Document 3JDaRYpXDDMg6VNZkBaYbZRwn
FILE NAME: Johnson & Johnson (JAJ) DATE: 2017 Aug 18 DOC#: JAJ019 DOCUMENT DESCRIPTION: Legal - Deposition of Dr. John Hopkins Part 4
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SUPERIOR COURT OF THE STATE OF CALIFORNIA
FOR THE COUNTY OF LOS ANGELES
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TINA HERFORD and DOUGLAS HERFORD,
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Plaintiffs,
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vs
Case No. BC646315
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AT&T CORP., a subsidiary of AT&T INC.
and its subsidiary PACIFIC BELL
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TELEPHONE COMPANY, et al..
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Defendants.
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VIDEO DEPOSITION OF DR. JOHN HOPKINS
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Day 4
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Friday, August 18, 2017
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AT: 10:03 am
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Taken at :
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Shook Hardy & Bacon LLP
25 Old Broad Street
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London EC2N 1HQ
United Kingdom
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Court Reporter:
DEIRDRA JORDAN
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25 Job NO. 2684109
Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
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SUPERIOR COURT OF NEW JERSEY
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SUPERIOR COURT OF NEW JERSEY
LAW DIVISION - MIDDLESEX COUNTY
LAW DIVISION - MIDDLESEX COUNTY
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DAVID CHARLES ETHERIDGE and
4 DARLENE PASTORE ETHERIDGE,
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Plaintiffs,
6 vs
Docket No.
MID-L-0932-17 AS
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BRENNTAG NORTH AMERICA, INC.
8 (sued individually and as
successor-in-interest to
9 MINERAL PIGMENT SOLUTIONS, INC.
and as successor-in-interest to
10 WHITTAKER CLARK & DANIELS, INC.)
et al.,
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Defendants.
12 ________________
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IRMAVERDOLOTTI,
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Plaintiff,
5 vs
Docket No.
MID-L-5973-16 AS
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BRENNTAG NORTH AMERICA, INC.
7 (sued individually and as
successor-in-interest to
8 MINERAL PIGMENT SOLUTIONS, INC.
and as successor-in-interest to
9 WHITTAKER CLARK & DANIELS, INC.)
et al.,
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Defendants.
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SUPERIOR COURT OF NEW JERSEY
LAW DIVISION - MIDDLESEX COUNTY
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RONALD MARTIN TEUSCHER and
4 SHANNON TEUSCHER,
5
Plaintiffs,
6 vs
Docket No.
MID-L-7249-16 AS
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BRENNTAG NORTH AMERICA, INC.
8 (sued individually and as
successor-in-interest to
9 MINERAL PIGMENT SOLUTIONS, INC.
and as successor-in-interest to
10 WHITTAKER CLARK & DANIELS, INC.)
et al.,
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Defendants.
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Appearing for the Plaintiffs:
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SIMON GREENSTONE PANATIER BARTLETT, PC
BY: CHRIS PANATIER, ESQ.
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BY: LEAH C. KAGAN, ESQ.
3232 McKinney Avenue, Suite 610
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Dallas, Texas 75204
214.276.7680
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cpanatier@sgpblaw.com
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8 Appearing for the Defendant Johnson & Johnson:
TUCKER ELUS LLP
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BY: SHARLA J. FROST, ESQ.
405 Main Street, Suite 500
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Houston, Texas 77002
972.537.4205
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sharla.frost@tuckerellis.com
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Appearing for die Defendant Johnson & Johnson:
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SHOOK HARDY & BACON LLP
BY: KATHLEEN FRAZIER, ESQ.
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JPMorgan Chase Tower
600 Travis Street, Suite 3400
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Houston, Texas 77002-2926
713.227.8008
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kfrazier@shb.com
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Appearing for Whittaker Clark & Daniels:
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HOAGLAND LONGO MORAN DUNST & DOUKAS LLP
BY: MARC S. GAFFREY, ESQ.
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40 Paterson Street, PO Box 480
New Brunswick, New Jersey 08903
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732.545.4717
mgaffrey@hoagtandlongo.com
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2 (Pages 1059 - 1062)
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1
A P P E A R A N C E S...(continued)
2 Attending via telephone:
LEVY KNIGSBERG LLP
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BY: MOSHE MAIMON, ESQ.
BY: DANIEL LATERRA, ESQ.
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BY: JEROME BLOCK, ESQ.
800 3d Avenue, 11th Floor
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New York, New York 10022
212.605.6200
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mmaimon@levylaw.com
dlaterra@levylaw.com
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jblock@levylaw.com
(For Plaintiffs in the Lanzo matter)
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9
HAWKINS PARNELL THACKSTON & YOUNG
BY: OLIVER BUNDY, ESQ.
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455 S. Figueroa, Suite 3200
Los Angeles, California 90071-1651
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213.486.8043
obundy@hptylaw.com
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(For Elizabeth Arden Inc., Revlon Inc.,
Bristol-Myers Squibb Company and Yves Saint
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Laurent America, Inc. in Herford case)
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FOLEY & MANSFIELD
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BY: M. AMADEA GROSECLOSE, ESQ.
300 South Grand Avenue, Suite 2800
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Los Angeles, California 90071
213.283.2100
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mgroseclose@foIeymansfield.com
(For Unilever United States, Inc. and
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Conopco, Inc. in Herford case)
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ORRICK, HERRINGTON & SUTCLIFFE LLP
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BY: C. ANNE MALIK, ESQ.
BY: ALLEGRA NOONAN, ESQ.
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1152 15th Street, N.W.
Washington, DC 20005
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202.339.8458
amalik@orrick.com
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anoonan@orrick.com
(For Johnson & Johnson)
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A P P E A R A N C E S...(continued)
2 Attending via telephone:
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MONTGOMERY McCRACKEN WALKER & RHOADS, LLP
BY: RONALD E. HURST, ESQ.
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123 South Broad Street
Philadelphia, Pennsylvania 19109
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215.772.7242
rhurst@mnrwr.com
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(For Brenntag Specialties in Teuscher case)
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COSMICH SIMMONS & BROWN
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BY: LaKEYSHA GREER ISAAC, ESQ.
100 Vision Drive, Suite 200
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Jackson, Mississippi 39211
601.863.2100
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lakeysha@cs-law.com
(For Shulton, Inc., sued individually and as
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successor to The Shulton Group and/or
Shulton, Inc.; The Procter & Gamble Company,
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sued as successor-in-interest to The Shulton
Group and/or Shulton, Inc.; and Wyeth Holdings
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LLC, filc/a Wyeth Holdings Corporation, f/k/a
American Cyanamid Company, sued individually
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and as successor-in-interest to The Shulton
Group and/or Shulton, Inc.)
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21
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23 ALSO PRESENT VIA TELEPHONE: DR. DAVID S. EGILMAN
24 VIDEOGRAPHER: LINDA FLEET
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1
A P P E A R A N C E S...(continued)
2 Attending via telephone:
3
DRINKER BIDDLE &REATH
BY: JACK N. FROST, ESQ.
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600 Campus Drive
Florham Park, New Jersey 07932-1047
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973.549.7338
jack.frost@dbr.com
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(For Johnson & Johnson in all but Herford)
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KING & SPALDING LLP
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BY: ALEXANDER CALFO, ESQ.
633 West Fifth Street, Suite 1700
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Los Angeles, California 90071
213.443.4365
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acalfo@kslaw.com
(For Johnson & Johnson in Herford case)
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RAWLE & HENDERSON LLP
BY: LINDA DOBBINS, ESQ.
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1339 Chestnut Street, 17th Floor
Philadelphia, Pennsylvania 19107
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215.575.4200
ldobbins@rawle.com
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(For Cyprus Amax Minerals Company
and Imerys Talc America in NJ cases)
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DENTONS US, LLP
BY: ERIN CARPENTER, ESQ.
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601 S. Figueroa Street, Suite 2500
Los Angeles, California 90017-5704
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213.623.9300
erin.carpenter@dentons.com
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(For Imerys Talc America, Inc. and Cyprus
Amax Minerals Company)
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HARRIS BEACH PLLC
BY: MATTHEW QUIRIN, ESQ.
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100 Wall Street
New York, NY 10005
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212.912.3505
mquirin@hamsbeach.com
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(For Glaxosmithkline in Teuscher matter)
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1
(On the record at 10:03 am)
2
VIDEOGRAPHER: W e are now on the record.
3 This is the continued deposition o f John Hopkins. The
4 date today is A ugust 18,2017, and the tim e is 10:03
5 am.
6
EXAM INATION:
7 BY MS FROST:
8
Q G ood morning, D r Hopkins.
9
A G ood m orning.
10
Q W e have been with you for about three days, but
11 since w e w ere doing the P la in tiff first, w e're in a
12 little b ito fre v e rs e order.
13
So I'm going to ask you, if you would,
14 please, can you introduce yourself to the ju iy ?
15
A Yeah. M y name is John Hopkins. M y academic
16 qualifications: I have a Bachelors degree in chemistry
17 and biochem istry from the U niversity o f St A ndrew 's in
18 S cotland and I have a P hD in toxicology from the
19 U niversity o f D undee M edical School in Scotland.
20
Q Do I also understand that you hold a membership
21 in one o f the R oyal Societies in connection w ith your
22 w ork as a toxicologist?
23
A Yes. I'm a chartered biologist, but I'm also a
24 m em ber o f the Royal Society o f Biology.
25
Q W hat is your relationship with Johnson &
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1 Johnson?
1 powder?
2
A Johnson & Johnson is a past employer. I had
2
A It did, indeed. Certainly, talc has always
3 started o ff m y w ork in toxicology. I worked in the
3 been a topic o f interest within Johnson & Johnson, and
4 pharm aceutical industry for a couple o f years from 1974
4 certainly from m y first joining the company in 1976,1
5 to 1976 and I jo in ed Johnson & Johnson, the U K com pany 5 w as involved in talking to people w ho are involved in
6 in 1976.
6 talc safety in the U nited States, regular m eetings, and
7
Q How long did you stay w ith the U K company?
7 basically keeping up to date w ith the literature and
8
A I stayed with the U K company until the end of
8 w hat was going on.
9 1994 and then I m oved to the U nited States com pany for 9
Q W e'll get back to that in m ore detail.
10 four y e a rs ,'9 5 ,'9 6 , '97, '98.
10
B ut I w ould like for you to tell the jury
11
Q W hat positions did you hold during the tim e
11 w h a t hav e yo u done p ro fessionally since yo u left
12 th at you w orked for Johnson & Johnson?
12 Johnson & Johnson in 2000?
13
A W hen I joined the U K company, I joined the
13
A I left Johnson & Johnson as a full-time
14 M edical D epartm ent, b asically w ith responsibility for
14 em ployee in 2000, and I m aintained contact w ith the
15 safety in toxicology.
15 co m pany as a co n su ltan t un til approxim ately 2011,
16
Q Did you later becom e the head o f the M edical
16 m ostly w ith the European affiliates.
17 Departm ent?
17
B ut in 2 0 0 0 ,1basically set up m y own
18
A I becam e the head o f the R& D group in the UK
18 com pany, a consultant toxicology com pany, and that
19 co m pany, a n d that's the po in t th en I relocated to the
19 com pany, w e w ork for basically anyone in the industry
20 U nited States to be responsible for the baby products
20 w ho has an interest in safety o f their consumer
21 R & D on a w o rld w id e basis.
21 products.
22
Q Let's talk a little bit about your
22
Q A s part o f your w ork as a consultant in your
23 responsibilities as a toxicologist during your 25 years
23 ow n business, do you continue to evaluate the safety o f
24 at Johnson & Johnson.
24 m aterials and carry out assessm ents o f safety for the
25
W hat did you actually do?
25 ingredients that go into products?
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A Basically, well, the role o f a toxicologist is
1
A That is correct, yes.
2 to ensure the safety o f the products, and not just baby
2
In pretty well all o f the toiletries and
3 products. Initially, I w as also involved in som e o f
3 cosm etics that you w ould go into W al-M art or any store
4 the professional products.
4 to buy, you w ould find that they list m any, many
5
But, as w e're talking about baby products and
5 different ingredients.
6 particularly baby powder, m y responsibility w as to
6
A nd the role o f the toxicologist is to ensure
7 ensure that the materials used in the products are
7 that each o f those ingredients is safe for the purpose
8 safe, and that's basically a toxicologist's role.
8 o f use.
9
Q Y ou m entioned term "professional products".
9
Q Do I understand that you are w hat is called a
10 W e've not heard that before. W hat are you talking
10 "cosm etic safety assessor" under the EU cosm etics
11 ab o u t w h en y o u talk ab o u t Johnson & Johnson's
11 directive program ?
12 p ro fessio n al products?
12
A Yes.
13
A W ell, certainly back in the 1970s, early 1980s,
13
Q C ould you explain that for the jury, please?
14 th e U K co m pany h a d overall responsibility for products 14
A Yeah. Essentially, in Europe products need to
15 th a t w e see n o w as hospital p roducts, surgical sw abs
15 have a file assem b led befo re they're p laced on the
16 th at are used in operating theaters, item s that
16 m arket. T hat's not a prem arket registration, but it's
17 surgeons u se, the gow ns, the h ead rest, and th o se kind
17 the responsibility o f the com pany to assem ble a file,
18 o f m edical products.
18 in cluding the safety o f the products.
19
But in the m id '80s, they w ere split out into
19
Part o f that is a requirem ent for a safety
20 a separate com pany and I stayed w ith the consum er
20 report, w hich typically could be 20, 30 pages long, to
21 company.
21 review the product, the safety o f the ingredients and
22
M S FROST: Can w hoever is on the phone please 22 any final studies.
23 m ute? W e're hearing feedback.
24
Q Did your role as a toxicologist call for you to
23
A nd to be an approved safety assessor, the
24 assessor needs to have the appropriate toxicological
25 assess the safety o f talc as an ingredient in the baby
25 background experience, and I have a qualification, a
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1 chartered biologist, w hich enables m e to be an approved
1 done over the years, assem ble that data as to the
2 safety assessor for European cosm etic products.
2 safety o f raw materials.
3
Q H ow m any o f those are there in Europe?
3
Q Have you personally published papers in the
4
A W ell, probably in total, probably several
4 field o f toxicology and biology?
5 dozen, m aybe a hundred m ore. In each country there's
5
A Yes, I have, yes.
6 maybe ten, 20 or 30 who operate privately through a
6
Q Can you give us just a sense o f the types o f
7 company, as I do.
7 papers and the volume that you have done?
8
M ost o f the large corporations w ill --the
8
A W ell, the papers I've published from the three
9 Unilevers, the Procter & Gambles, those kind o f
9 and a half, four years I did for m y PhD thesis were
10 com panies tend to have their ow n inhouse people.
10 related to the w ay that certain dm gs react on red
11
But people w ho operate as I do as a company,
11 b lo o d cells in the body.
12 probably ten, 1 5 ,2 0 in the UK. Probably sim ilar
12
I was lucky enough to do m y PhD in a teaching
13 n u m bers in o th er countries.
13 hospital, so w e h ad exam ples o f getting hum an blood
14
Q Now, you said that you had a PhD in -- did
14 sam ples and w e looked at the w ay that certain dm gs
15 I und erstan d p h arm acology an d toxicology?
15 reacted w ith those people.
16
A That w as the w ork I did, yes, for m y PhD.
16
I have done other work since then in the
17
Q A nd w hat is pharm acology and toxicology?
17 cosm etic industry. O ne o f the problem s, o f course, is
18
A Pharm acology is the study o f the way that
18 that a lot o f that w ork is confidential and it tends to
19 drugs, m edicines w ork in the body, how the body reacts 19 be retained w ithin the industry and you don't alw ays
20 to them , w hat kind o f w ay that they w ork. I f you've
20 publish it, but I have done other w ork on skin safety
21 g o t a h eart d ru g o r a n antibiotic, it's th e w a y it
21 o f a num ber o f products.
22 works.
22
Q In addition to having done written
23
Toxicology relates to the safety o f those
23 publications, have you also presented at conferences
24 m aterials. So for any given m aterial, w e need to know
24 and so on on the issues o f toxicology and biology?
25 w hat is a safe level. You know, how m any aspirin can
25
A Yes, I have. Certainly since I set up m y
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1 you take that w on't harm you? That's a very sim ple
1 consultancy company, I have presented to young
2 example.
2 scientists, young toxicologists, people particularly in
3
So a toxicologist looks at issues like the
3 the cosmetic industry to give them an understanding o f
4 dose response, how safe is one aspirin versus 20? A nd
4 h o w p ro d u ct safety is evaluated for cosm etics. I've
5 the same applies to antibiotics and m aybe heart drugs,
5 done that at a num ber o f professional societies.
6 dm gs for epilepsy.
6
Q D r Hopkins, this m orning I want to talk with
7
So the toxicologist will leam to understand
7 you about a variety o f topics, including talc, Johnson
8 w hat are the side effects o f those drugs, and the basis
8 & Johnson a n d its history, Johnson & Johnson's use o f
9 o f that originally was how do they behave in rats and
9 talc, its evaluation o f safety and so on, and we're
10 m ice. W e look nowadays at how chem icals and dm gs
10 going to deal with those individually.
11 b eh av e in cell cultures system s.
11
B ut before w e do that, because some o f the
12
Y ou're essentially looking for how the drug
12 questioning over the last three days had to do w ith
13 reacts w ith b o d y o r w ith cells.
13 v ery specific docum ents th at raised questions that I
14
Q Have you personally done any work in your
14 believe need to be handled upfront, I w ould like for
15 c are er to do th at so rt o f in d ividualized assessm ent on
15 you to go through w ith m e som e specific docum ents that
16 pharm aceutical m aterials?
16 M r Panatier talked about, and then w e're going to get
17
A Yes. I m ean, going back to w hen I w orked in
17 back to the issue o f Johnson & Johnson and w ho it is
18 th e p harm aceutical industry, I w as responsible for
18 and w hat it w as doing.
19 antibiotic safety program s. I had a team o f people and
19
B ut before w e get into the individual
20 w e developed products that certain types o f synthetic
20 docum ents, I'd like to ask you can you tell the ladies
21 penicillins and antibiotics, and it m eans doing anim al
21 and gentlem en o f the jury w hether or not, from your
22 safety studies before they're launched on the market.
22 position both as a corporate representative and also as
23
Essentially, o f course, w hen you com e into
23 a scientist, a toxicologist, is it important to
24 the cosmetic industry, the data is available in the
24 evaluate the totality o f m aterials before you reach a
25 public literature, so you can read w hat others have
25 conclusion?
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A Yes. It's good scientific practice to, w hen
1
A No, it does not, no.
2 you're evaluating any chem ical, any substance, and not
2
Q I'm going to put a zero w ith a line through it,
3 ju st in the cosm etic industry, but the sam e applies to
3 and w e will understand that that means no.
4 foods and food additives, that you aim to find all the
4
But in connection w ith the evaluation o f this
5 data you can -- good, bad, indifferent --and read it
5 docum ent, does this provide you any information to use
6 all and com e to an overall conclusion.
6 to assess either the safety o f the talc being purchased
7
Q Likewise, can you tell us w hether or not you
7 by Johnson & Johnson at any time or the behavior
8 believe that it is im portant to look at the totality o f
8 associated with that purchase?
9 the docum ents that are being evaluated in connection
9
A No, it does not.
10 w ith the questions that have been raised here?
10
Q You m ay set that aside.
11
A Yes. The sam e i s - - the sam e situation
11
The next docum ent w e're going to look at it
12 applies. It's im p o rtan t to rev iew all docum entation.
12 is nu m b er 22.
13
Q Okay.
13 (E xhibit 22, p reviously m arked, handed to w itness)
14
The first docum ent I w ould like for you to
14
A nd this document, if you w ould take a look
15 lo o k a t -- I'm g oing to try an d do these so rt o f in
15 a t it, p lease --
16 n u m erical o rd er to m ake it easier fo r all o f u s an d for
16
A Okay.
17 th e ju ry , b u t i f y o u w ould look, w e have the stack here
17
Q --M r Panatier asked you som e questions, but
18 o f the docum ents th at have b een adm itted into the case, 18 I'm g oing to a sk th at y o u tu rn to the flag on the
19 a n d the first do cu m en t th at w e w an t to lo o k at is
19 docum ent.
20 num ber 17.
20
A nd the question that I have for you, in
21
Here, I w ill give you m y copy. I can see it
21 connection w ith the m ine in Italy from w hich Johnson &
22 from here.
22 Johnson received its talc, does this docum ent help us
23 (Exhibit 17, previously m arked, handed to witness)
23 identify the specific m ine from which its talc was
24
A Thank you.
24 received?
25
Q Do you rem em ber this docum ent from the
25
A Yes, it does actually name the mine.
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1 questioning by M r Panatier?
1
Q A nd w hat is the nam e o f that mine?
2
A Yes, I do, yes.
2
A It says in one sentence:
3
Q I'm going to go to the board.
3
"All o f the J& J talc w ill com e from the
4
Now , that's a docum ent that --a 1948
4 Fontana M ine".
5 docum ent that purports to be betw een one governmental 5
Q In connection with evaluating the documents in
6 agency and another, does it not?
6 this case, is it important to distinguish between the
7
A It does, yes.
7 various m ines in the Val Chisone area?
8
Q W ho does it say it's from and w ho does it say
8
A Y es, it is.
9 it's to?
9
Q A nd w hy is that?
10
A W ell, the heading on the notepaper is the
10
A W ell, there are m any different mines. The Val
11 F ederal Security A gency, U S P u blic H ealth Service,
11 C hisone area covers a v ery large acreage. T here are
12 W ashington --yeah, W ashington D C.
12 m any, m any m ines in the Val C hisone valley, and w hat
13
Q A nd the topic o f this docum ent has to do with
13 th is identifies is the specific m ine th at the Johnson &
14 findings in the V erm ont m ines, does it not?
14 Johnson talc com es from.
15
A It does, yes. It's authored to M r H arry Ashe,
15
Q In evaluating the documents that are introduced
16 D ivision o f Industrial H ygiene in the S tate o f V erm ont, 16 in this case, w o u ld yo u tell u s w h eth er o r n ot it is
17 D ep artm en t o f P ublic H ealth, V erm ont.
17 im portant fo r the readers o f those docum ents to take a
18
Q Is there anything on that docum ent that
18 look at w hich m ine is being discussed as it --he or
19 indicate th at it is w e n t eith er to Johnson & Johnson or
19 she evaluates w hat is being talked about in the
20 to the W indsor m ines?
20 documents?
21
A N o. N o, it doesn't m ention Johnson & Johnson,
21
A It is important, yes. If we review documents
22 nor does it m ention the W indsor mine.
22 that relate to a different m ine, then it's not relevant
23
Q The docum ent itself, does it indicate in fact
23 to Johnson & Johnson.
24 anything about the identity o f the m ine that is being
24
Q Y ou m ay set that aside.
25 discussed as part o f the correspondence?
25
In evaluating the issues related to the
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1 individual m ines, M r Panatier asked you some questions
1 report to Johnson & Johnson in connection with the
2 about the variability o f the m ines and the fibers and
2 evaluation o f the H am m ondsville m ine?
3 the geology.
3
A They concluded that the reserves were
4
W ould you, as a toxicologist, rely on the
4 3.75 m illion tons o f ore containing 767,000 tons o f
5 geologists, w ho are fam iliar with the mineral
5 platy talc.
6 structures and developm ents o f the individual m ines, to
6
Q A nd rem ind us, please, w hat is platy talc and
7 provide inform ation about the type o f m inerals in an
7 w hy is that significant?
8 individual deposit?
8
A Okay. Platy talc is the kind that's used in
9
A Yes. The geologist is the expert who would
9 the cosm etic industry. Essentially, if you were to
10 understand the quality o f the m ine, or he or she w ould
10 look at a sam ple o f the talc under a m icroscope, you
11 u n d erstan d the kin d o f m in eralo lo g y in the m ine, and
11 w ould see it looks like little d in n er plates, little
12 w ould give a professional overview o f the quality o f
12 side plates.
13 th e talc from the m ine.
13
A nd the point o f the platiness is that when
14
Q During the tim e that you were working for
14 one little plate slides over another, it gives that
15 Jo hnson & Johnson, d id y o u rely o n outside geologists
15 sm ooth, silky feeling th at you're looking for on the
16 to provide you w ith inform ation concerning the m ineral 16 skin and prevents chafing.
17 content o f the m ines from w hich talc w as received?
17
Q D id they conclude in their report to Johnson &
18
A Yes, yes, I did. I was aware that the company
18 Johnson that there w ere asbestos m inerals in the
19 had chartered a specific geologist to exam ine the
19 H am m ondsville m ine?
20 quality o f the m ines involved.
20
A They concluded there w ere no asbestos materials
21
Q A nd w e're going to talk in som e detail about
21 in the H am m ondsville m ine.
22 the specific geologist and the findings.
22
Q W hat was the date on that, please?
23
But, in general, you were asked some
23
A The report is dated Decem ber 4,1970.
24 questions about docum ent 36, and I'm going to hand you 24
Q L et's turn now to num ber 41.
25 the cover page o f that.
25 (Exhibit 41, previously m arked, handed to witness)
Page 1080
Page 1082
1 (Exhibit 36, previously m arked, handed to witness)
1
This is a docum ent from w hich M r Panatier
2
Can you tell us w ho it shows to have
2 read som e portions. H e asked you to read portions of
3 conducted the evaluation on the m ine reflected in
3 the document, but he did not ask you to read the
4 number 36?
4 rem ainder o f the document.
5
A The title is Colorado School o f M ines, Geology
5
If you w ill take a look at this?
6 and Ore Reserves, H am m ondsville M ine, W indsor Mineral s 6
M R PANATIER: Sorry, what?
7 Inc:
7
M S FROST: Exhibit num ber 41.
8
"The attached report completes our w ork on
8
M R PANATIER: Okay.
9 th e nature a n d m agnitude o f ... [the] ore b o d y in
9
TH E W ITNESS: Okay, I've taken a look at
10 Verm ont from w hich w e m anufacture B aby Pow der talc". 10 this, yes.
11
Q Thank you.
11 B Y M S FR O ST :
12
A nd then let's look, w hat did they report to
12
Q Okay. W ho is that from and who is that to?
13 h av e been th e objective o f the stu d y th a t w as
13
A It is from D r Nashed in Johnson & Johnson to a
14 com m issioned from the Colorado School o f M ines by
14 M r L Foster in Johnson & Johnson.
15 Jo hnson & Jo h n so n in co nnection w ith the H am m ondsville 15
Q A nd w hat does M r N ashed report to M r Foster?
16 m ine?
16
A He describes the ore manufacturing process and
17
A The Colorado School o f M ines stated that:
17 he states that:
18
"The objective o f this study w as to estimate
18
"The ore undergoes a careful purifying
19 an ore reserve tonnage and quality o f the H am m ondsville 19 process w hich includes a 36-step w ashing process to
20 mine. In conjunction w ith this, it was necessary to
20 m axim ize its content o f high lubricity platy talc ..."
21 study in detail the geology o f the m ine and the
21
Q Okay. Stop right there. Thirty-six step
22 m ineralology o f the ore m aterial. This latter
22 washing process.
23 information w ill facilitate future m ine developm ent and 23
W ould that indicate to you whether or not the
24 planning".
24 com pany w as taking efforts to ensure that it had the
25
Q A nd w hat did they ultim ately conclude and
25 finest quality o f talc to use in its baby powder?
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1
A It would, yes.
1
M r Panatier didn't ask you to read this
2
Q A nd then you read a portion o f this document
2 particular paragraph w hen you talked with him about the
3 earlier, but the paragraph I w ould like for you to read
3 document. Can you read that paragraph and explain to
4 into the record is the final paragraph o f this
4 us the significance o f it?
5 d o cu m en t, w h ic h M r P an atier d id n 't a sk y o u about.
5
A Yeah.
6
C ould you please read that for us and then
6
"I have just re-exam ined the G -l 1 sample and
7 I'll have a couple o f questions?
7 find no chrysotile in the second sample. There w as one
8
A Yeah.
8 fiber, but it gave a different diffraction pattern from
9
"W e w ill be receiving som etim e next w eek a
9 that o f chrysotile."
10 rep o rt from o u r consultant, P ro fessor F D P o o le y ...
10
Q W hat --if you would, please, remind us the
11 U n iv ersity C ollege o f W ales ... G reat B ritain. H e has
11 d iffractio n pattern? W h at is the significance o f that?
12 com pleted an exhaustive exam ination o f a sam ple o f baby 12
A W ell, w hen you're using x-ray diffraction, for
13 p o w d er b y electron m icroscopy a n d o th er sophisticated 13 exam ple, yo u g e t a num erical --a num erical v alue can
14 techniques. H is o ral report is ... it contain s no
14 be printed out or presented that identifies different
15 asbestos."
15 crystalline structures and it's given a num erical
16
Q Two things there.
16 num ber.
17
W hat type o f testing does it indicate that Dr
17
So, essentially, you get a num ber and you try
18 P o o ley co n d u cted on the b ab y p o w d er sam ple?
18 and m atch up that num ber w ith the kind o f m ineral
19
A Electron m icroscopy.
19 that's present.
20
Q W ould you rem ind us, please, w hat is the
20
Q So we now have --from the documents you
21 significance o f using electron m icroscopy versus som e
21 review ed with M r Panatier, w e have an evaluation o f the
22 other method o f evaluating the baby powder?
22 Ham m ondsville m ine in 1970 and it reflects no asbestos,
23
A W ell, electron microscopy, transmission
23 w e have the Pooley report in 1971 that reports no
24 electron m icroscopy, or other m eans o f electron
24 asbestos, and w e have the M cC rone report in 1971 that
25 m icroscopy, allows you to go right dow n to look at
25 reports no chrysotile, w hich w ould be no asbestos in
Page 1084
Page 1086
1 parts per m illion o f a product.
1 the sam ple that was evaluated.
2
In other words, it is very, very
2
From your perspective on behalf o f Johnson &
3 sophisticated.
3 Johnson, w hat is the significance o f those reports from
4
Q The date again on that?
4 the outside consultants?
5
A The date on that is July 29, 1971.
5
(Tannoy sounded)
6
Q S o in l 9 7 1 ,a report from D r Pooley was, what?
6
(O ff the record at 10:30 am)
7
A It essentially said his oral report is that the
7
(O n the record at 10:33 am)
8 baby powder contains no asbestos when m easured by
8 BY MS FROST:
9 electron --electron m icroscopy.
9
Q Doctor, before the fire alarm, we were talking
10
Q Y ou m ay put that aside.
10 about w hat is the significance, from the perspective o f
11
The next docum ent I'd like you to look at is
11 Joh n so n & Johnson, to have received in the 1970 a n d '71
12 num ber 44, w hich M r Panatier asked you som e questions 12 tim e period these three different reports in connection
13 about.
13 w ith their talc?
14 (Exhibit 44, previously m arked, handed to witness)
14
A W ell, the significance was that coming from
15
If you w ould take a quick look at that, who
15 different people, it w as clear that there w as no
16 is that from?
16 asbestos in the talc that w as Johnson's Baby Pow der and
17
A It's from an outside agency, W alter M cCrone
17 Johnson's products.
18 A ssociates to --
19
Q W hat's the date?
18
Q Y ou m ay set that particular document aside.
19
The next docum ent we are going to look at is
20
A It is dated September 3,1971.
20 Exhibit num ber 55, w hich M r Panatier talked with you
21
Q W hat does it report?
21 about.
22
A It reports the prelim inary report on the
22 (Exhibit 55, previously m arked, handed to witness)
23 Grantham ore in the Shower to Shower m edicated powders .23
B ut there was a period that he did not ask
24
Q And if you w ill turn to the next page to the
24 you to read that I'm going to ask you to take a look
25 paragraph that I have marked?
25 at.
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1
But, first o f all, num ber 55, this is the
1 provide inform ation useful in the comminution o f
2 w ritten report from D r Pooley, is it not?
2 particularly the talc ore samples, and also displays
3
A It is, yes, yes.
3 the non occurrence o f asbestiform am phiboles in the
4
Q And w hat does it reflect here on the front
4 talc ore".
5 cover?
5
Q A couple o f questions for you on that.
6
A It is --the title o f the report is from the
6
The im plication from the questioning by
7 Departm ent o f M ineral Exploitation, U niversity College
7 M r Panatier was that the photom icrographs indicated a
8 Cardiff, W ales.
8 presence o f asbestiform m ineral in the ore deposits
9
Q A nd for those o f us w ho are A m ericans and don't
9 evaluated by D r Pooley in Italy.
10 really understand the significance o f the University
10
Based on the final w ritten report, can you
11 C ollege o f C ardiff, w h y w as the U niversity C ollege o f
11 tell u s w h eth er or n o t th at is an accurate im plication?
12 C ardiff an appropriate outside consultant to retain to
12
A It doesn't reflect w hat the geologist wrote.
13 evaluate a m ineral issue o n b e h a lf o f Jo h n so n &
13 H e states very clearly:
14 Johnson?
14
"... the non occurrence o f asbestiform
15
A T hat particular university department has a
15 am phiboles in the talc ore".
16 long-standing expertise in understanding m ineralology. 16
Q Remind us, if you would, what is the
17 In th at particu lar locality, there has b een o v e r a
17 relationship betw een an am phibole and asbestos, since
18 h u n d red y ears o f m ining, m o stly coal b u t also iron ore,
18 the language there is slightly different than ju st
19 an d so m ineral expertise develops around that in the
19 asbestos?
20 universities and colleges.
20
A Yes. Am phiboles can occur in asbestosform or
21
A nd so that expertise developed into a very
21 n o t asbestosform , a n d w h at he's saying is there's no
22 high quality geology department that cam e with some
22 asbestos amphiboles present.
23 very experienced people.
23
Q The language o f that report conclusion would
24
Q A nd w e spoke yesterday and the day before and
24 seem to indicate that the photomicrographs that were
25 the day before that about D r Pooley. Is D r Pooley one
25 attached and illustrated by Plaintiffs' counsel earlier
Page 1088
Page 1090
1 o f the faculty m em bers there, or did he have some other
1 this w eek related to areas o f the m ine other than the
2 relationship with the university?
2 m ine ore.
3
A He w as initially a leading researcher and then
3
W hy w ould that inform ation be provided in the
4 he became Professor in the m ineralology department.
4 context o f a report o f this nature?
5
Q Right.
5
A Essentially, i f you are entering a mine, you
6
W hat I w ould like for us to turn to, w e saw
6 will come across different kinds o f rock. It was
7 on Exhibit num ber 41 that in the paragraph that was not
7 form ed in the geology m any, m any millions o f years ago.
8 read into the record that D r Pooley had provided an
8
It's im portant w hen you're m ining that you
9 oral report that there was no asbestos.
9 know w hat else is there besides the talc ore. So it's
10
However, this is a w ritten report. Can you
10 n o t unreasonable to have a look at w hat the else is in
11 tak e a lo o k a t pag e that's B ates nu m b ered 95 a n d read
11 th e m ine a n d know w here to go a n d w here to avoid.
12 for us w hat did the ultim ate conclusion o f the w ritten
12
Q You m ay set that one aside.
13 rep o rt dem onstrate in co nnection w ith the evaluation o f 13
Let's take a look at docum ent num ber 56,
14 the talc used by Johnson & Johnson?
14 w hich you talked about w ith M r Panatier.
15
A Yeah.
15 (E xhibit 56, previously m arked, handed to w itness)
16
Professor Pooley presented a report from his
16
I f you w ould like a look at that, w hat is
17 studies in the m ine, a very detailed report, it looks
17 num ber 56?
18 like alm ost an inch thick, but he essentially
18
A It is a letter from D r Nashed o f Johnson &
19 sum m arizes on this first page:
19 Johnson. It's a m em o to the file, a report o f a
20
"In the following pages (no. 7 to 48) the
20 m eeting at the FD A in Septem ber 21, 1972.
21 Italian specim ens are system atically described as
21
Q Right. L et m e stop you there.
22 regards [to] their m ineral com position and m ode o f
22
So in 1972, the company was m eeting with the
23 intergrowth. N um erous photom icrographs taken under PP .23 FDA; correct?
24 and XN are provided with the description to mainly
24
A This is a report o f that meeting, yes.
25 illustrate the rock textures which, it is hoped, will
25
Q A nd can you rem ind us was it obligatory for
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1 Johnson & Johnson to meet with the FDA, or was it
1
Q W hat is a talc shard?
2 voluntary for them to meet with the FDA?
2
A V ery simply, talc norm ally takes the form o f a
3 A No, it's always been voluntary.
3 plate-like structure, but if you break a plate you will
4 Q In connection with this particular document,
4 end up with a piece that is not any longer the shape o f
5 look at paragraph 1.
5 a plate, b ut a piece that's broken off.
6
Who joined the Johnson & Johnson team to make
6
So a talc shard could well have a non-platy
7 this particular presentation to the FDA?
7 appearance, but it's still talc.
8 A It was Dr Pooley from University of Wales in
8
Q The docum ent goes on to describe what happened
9 the UK.
9 further in the m eeting.
10 Q And I believe you discussed one portion of this
10
H ow did they characterize how the m eeting
11 paragraph with Mr Panatier, but the portion that he
11 w e n t w ith D r L ew in?
12 didn't read I have marked at the bottom.
12
A W ell, w hen I read this, I think they were
13
Can you read for us, please, what did Dr
13 hav in g a little d ifficu lty w ith D r L ew in, becau se it
14 Pooley report to the FDA in connection with his
14 states:
15 evaluation of talc from Turin?
15
"The m eeting w as beginning to deteriorate in
16 A Yes. H e - - Dr Pooley:
16 a nonfruitful pathw ay. I interrupted to suggest a
17
"He pointed out that the mine contained two
17 com prom ise, nam ely, that D r L ew in has carried out the
18 species of chlorite ore which show x-ray peaks which
18 procedure w e h ad agreed on in the last m eeting. It was
19 could be confused with chrysotile asbestos. He also
19 one obvious that the X -ray scan d id not show definitive
20 mentioned that the Italian Mining Institute at Turin
20 chrysotile, [and] that m icroscopy was indicated, and
21 ... [had] also determined no chrysotile asbestos in the
21 since D r M cC rone is very fam iliar w ith this technique,
22 mine. He presented data on [the] SHOWER-TO-SHOWER and 22 I su g g ested th at the decisio n be m ade th at D r L ew in
23 Italian talc samples provided by Johnson & Johnson
23 w ork w ith D r M cCrone to establish the best microscopy
24 England dating back to 1949, establishing [the] absence
24 technique to be followed. D r Schaffer [FDA] obtained
25 of chrysotile asbestos by various techniques,
25 [an] ag reem en t f r o m ... [D r] L ew in an d [Dr] M cC ron e to
Page 1092
Page 1094
1 (E lectron] M icroscopy, diffraction, X-ray, and
1 im plem ent this suggestion".
2 m icroscopy)".
2
Q In connection with the w ork that the FDA was
3
Q So w hat is the significance o f the inform ation
3 doing with talc, can you tell us w hether or not this
4 presented by D r Pooley to the FDA in connection with
4 indicates that Johnson & Johnson and the outside
5 this particular m eeting?
5 consultants it had retained were co-operating with the
6
A It essentially can be sum m arized that there was
6 FD A in order to evaluate the appropriate techniques for
7 no asbestos in the US Shower to Show er product and
7 the evaluation o f the talc that was being sampled?
8 there was no asbestos in the Italian talc samples from
8
A I w ould say that very m uch indicates
9 today.
9 co-operation. There's free exchange o f ideas and
10
That w as 1972 and going back to 1949.
10 suggestions to m ove things forward.
11
Q If you w ill flip to the second page, please -
11
Q A ll right. Y ou m ay set that one aside.
12 I g uess it w o u ld b e th e th ird page, I can 't count this
12
N ext docum ent w e are going to look at is
13 m orning.
13 an o th er th at y o u talk ed ab o u t w ith M r P anatier, n um b er
14
There is another paragraph w hich M r Panatier
14 63. D o you recognize that one?
15 d id n o t ask y o u to review . L o o k at the first paragraph
15 (E xhibit 63, previously m arked, handed to w itness)
16 a t the top o f th e page on p ag e 3, an d i f y o u c o u ld read
16
A Yes.
17 th a t for us, an d th en I'll have a couple o f questions?
17
Q And this one is dated what?
18
A "D r M cC rone [w ho w as also present] review ed the 18
A This one is dated June 28,1977.
19 d a ta b y D r L ew in a n d po in ted o ut a logical explanation
19
Q Now , in the portion that you talked with
20 for what D r Lew in w as seeing, nam ely, [that] the talc
20 M r Panatier about, you - he focused on som e o f the
21 h ad not one b ut three refractive indices, and D r
21 evaluation techniques, b u t w hat I w ould like to look at
22 Lew in's observations only indicated this fact and not
22 is w hat the docum ent says about the purpose o f the
23 the presence o f chrysotile. D r Stewart pointed out
23 audit m eeting in connection w ith W indsor 66 talc?
24 that D r Lew in's photographs indicated only talc
24
A It states very simply:
25 shards."
25
"To form alize the audit testing currently
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1 perform ed to ensure the absence o f asbestos in W indsor
1
Q A nd rem ind me, please, w hich m ine is that?
2 66 Talc, the following protocol is currently being used
2
A This relates to the W indsor m ine, producing
3
H
3 talc grade 66.
4
Q W hy would Johnson & Johnson be performing an
4
Q You m ay set that one aside.
5 audit o f the talc that is being used and characterized
5
N ext docum ent is docum ent num ber 81.
6 as W indsor 66?
6 (Exhibit 81, previously m arked, handed to witness)
7
A Essentially, the same reason I m entioned a
7
W hat is the date on that, please?
8 little while ago that you need to ensure that you have
8
A It's dated 20 October, 1975.
9 a clean m ine and that the m ine does not contain
9
Q To whom is it addressed and from whom?
10 asbestos.
10
A It's from W alter M cC rone A ssociates, Consulting
11
Q And w hen the phraseology that it uses --
11 L aboratory, an d it's ad d ressed to M r R o g er M iller o f
12
A Very simple. It says:
12 the W indsor M inerals C om pany in Verm ont.
13
"... to ensure the absence o f asbestos in
13
Q Now, M r Panatier asked you some questions about
14 W in d so r 66 T a l c ..."
14 the second sentence o f the third paragraph in this
15
Q You m ay set that one aside.
15 docum ent.
16
N ext document that he talked with you about
16
W ould you please read the entirety o f that
17 a n d h a d y o u read som e portions, b u t n o t all, is n um ber
17 paragraph to give u s context?
18 69.
18
A Yeah. The first sentence was, w e discussed
19 (E xhibit 69, p reviously m arked, h an d ed to w w itness)
19 yesterday:
20
W hat is num ber 69?
20
"None o f the m ethods o f examination showed
21
A It's a report described as N ew Reagent
21 any evidence o f asbestiform m inerals present in any o f
22 System s - Plant Trial at W indsor M inerals Inc.
22 the three samples. Both light m icroscopy and
23
Q Can you tell what the date o f that is? Do we
23 transm ission electron m icroscopy indicated that the
24 have a date on that document?
24 unbeneficiated talc was som ewhat m ore fibrous than the
25
A n d i f th ere's n o t on e easily -
25 H am m ondsville talc to w hich w e ... [w ere] accustom ed".
Page 1096
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1
A W e do not. W e do not, no.
1
Q Then on the next paragraph w hat does --w hat do
2
Q Okay.
2 they conclude concerning their evaluation o f the
3
Now, I believe you spoke with M r Panatier
3 m aterials that they were looking at?
4 about some inform ation on the sort o f the first and
4
A The last sentence sim ply states:
5 last pages.
5
"No evidence o f... amphiboles were
6
But the part I wanted to focus on that we did
6 detected".
7 not look at is on page 5 o f the document.
7
Q You m ay set that one aside.
8
Looking at the first paragraph on page 5,
8
N ext document that he talked with you about
9 w hat does that report concerning the am phibole content
9 that I w ould like to look at is num ber 83.
10 in the talc product?
10 (E xhibit 83, previously m arked, handed to w itness)
11
A "There were no significant differences with
11
This is a docum ent from 1980. W hat is this
12 resp ect to th e am phibole co n ten t in the test products.
12 one?
13 T h e d etected am phibole m inerals d id n o t appear [to be] 13
A It's a docum ent dated O ctober 17,1980, and
14 ... fibrous [in] form in any o f the product sam ples."
14 it's titled Procedure for Identification and
15
Q Okay.
15 Q uantification o f A m phibole Particles in J& J Talcs
16
So no fibrous form o f amphibole in the
16 U sing O ptical M ineralogical M icroscopy.
17 p ro d u ct sam ples; is th at correct?
17
Q A nd M r Panatier asked you about the first line,
18
A That is correct. There w ere no fibers present.
18 w hich talked about the techniques u sed to evaluate talc
19
Q W hat is the significance o f that com m ent to you
19 for the freedom from asbestos m inerals, b u t he d id not
20 in your role as a toxicologist, or as a corporate
20 talk with you about the general comm ents that explain
21 representative?
21 the process.
22
A It provides an ongoing reassurance that,
22
First o f all, w hat is this particular
23 certainly in the m ine and the evaluation o f the mine,
23 docum ent? W hat is the im port o f it?
24 there is no am phibole m aterials present that are
24
A It's a Johnson & Johnson docum ent and it
25 asbestos.
25 describes the procedures that are follow ed to examine
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1 talc for freedom from asbestos.
1 talcs.
2
It reports the techniques, optical
2
I am m arking deposition Exhibit num ber 220 in
3 m icroscopy, CTFA m ethod J4 using x-ray, and, third,
3 connection w ith the docum ent num ber 84.
4 scanning electron microscopy, plus dispersive x-ray
4
(Exhibit 220 m arked for identification)
5 analysis for particles less than 5 microns.
5
Have you seen docum ent num ber 220 previously?
6
A nd then they m ove on to state General
6
A I think I have seen this, yes. Yes, yes.
7 Comments:
7
Q A nd w hat does num ber 220 tell us?
8
"The m ethod is applicable to the amphibole
8
A It says:
9 type m inerals in the size o f 5 m icrons and above. In
9
"W e are sending seven sam ples for asbestiform
10 ... all cases am phibole ob serv ed is specifically
10 analysis v ia transm ission electron m icroscopy".
11 trem olite, o r actinolite i f iron is present. T he
11
That's from W indsor M inerals Inc to Electron
12 trem olite/actinolite ob serv ed in talcs is presen t in
12 O ptics G roup at W alter M cC rone A ssociates.
13 relativ ely large particle size, e.g., one d im ension at
13
Q Right, and do the num bers there correspond with
14 2 0 m icrons o r greater".
14 the num bers reported on the report from A ugust, w hich
15
A nd then it states that:
15 is do cu m en t nu m b er 84?
16
"The particle shape is non-fibrous and ranges
16
A Yes.
17 fro m eq u an t gran u lar to th ick co lum nar elongated
17
Q Okay.
18 p articles w ith parallel prism atic cleavage".
18
I am m arking number 221.
19
Q Can you put that in plain English for those o f
19
(Exhibit 221 m arked for identification)
20 us w ho don't speak science? W hat do they m ean in that 20
M r Panatier.
21 last particular sentence there?
21
This is another docum ent related to the
22
A Sim ply they're saying that w here you find
22 samples. If you would take a look at that, please,
23 trem olite/actinolite m aterial, it is not fibrous in
23 w hat does that tell us about the samples w hose numbers
24 nature.
24 correspond to the report reflected in num ber 84?
25
It w ould be described as "chunky" m aterial,
25
A Those seven samples are described as Grade 76,
Page 1100
Page 1102
1 but certainly not fibrous in nature.
1 Grade 76, Grade 76, Grade TC-700, Grade 76, Grade
2
Q A nd i f the trem olite is not fibrous, w hat is
2 TC-700, Grade 76.
3 the significance o f that?
3
Q W hat is the significance o f the Grade 76
4
A It is not asbestos.
4 designation as it relates to these particular examples?
5
Q You m ay set that aside.
5
A W ell, it clearly differentiated it from the
6
You were show n a num ber o f documents related
6 talc that's used in baby pow der, w hich is W indsor Grade
7 to m ineral sam ples that were done by the M cCrone
7 66.
8 Environm ental Services Laboratory and you talked a
8
Q W hen you review ed the transmittal letter, the
9 little bit w ith M r Panatier yesterday about the
9 schedule and the report, w hat does that tell you
10 ch aracterization o f sam ples th at have the p refix W M I,
10 concerning the evaluation and any m ineral content
11 an d I w an t to return to that.
11 related to the m inerals ev alu ated an d reported in
12
L et's look at docum ent num ber 84.
12 d o cu m en t nu m b er 84?
13 (E xhibit 84, p reviously m arked, h an d ed to w itness)
13
A Essentially, those seven m inerals that were
14
W hat is your understanding o f the
14 evaluated w ere not relating to the talc that's used in
15 sig nificance o f the d escrip to r W H I?
15 Jo hnson's B aby P o w d er o r S how er to S how er products.
16
A W MI.
16
Q W as it alw ays the case that the talc grade used
17
Q W M I, I'm sorry?
17 for baby pow der from W indsor w as G rade 66?
18
A Y eah. It describes product that's com e from
18
A G rade 66 is the reference given to talc that's
19 W indsor M inerals Inc, W M I.
19 alw ays been used for baby pow der.
20
Q A nd I am going to --w hat does the I indicate
20
Q So in evaluating the documents, it w ould be
21 as part o f the extension?
21 im portant for the jurors not ju st to m ake sure that the
22
A M y belief is that I --these were industrial
22 m ine being discussed in the docum ent is the same, but
23 talcs.
23 it's also im portant to identify that --w hether or not
24
Q Let's talk a little bit about that to m ake sure
24 the exact sam ple is in fact Grade 66 or some other
25 that we can confirm that these in fact are industrial
25 grade?
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1
A Yes, there needs to be a clear differentiation.
1 BY MS FROST:
2 O nly G rade 66 is used in baby powder, and these results 2
Q B ack to the question.
3 do not relate to the talc that's used in baby powder.
3
In connection w ith the results reflected in
4
So -
4 num ber 84, do those results tell us about the mineral
5
M R PA NATIER: Can I ju st --I'm going to
5 content o f cosmetic baby powder or not?
6 state for the record, these docum ents w eren't produced
6
A No, those results have no relevance to cosmetic
7 to us here. These appear to be from the ovarian
7 baby powder.
8 production. So I never got these.
8
Q Y ou m ay set that aside.
9
But, anyw ay, I'm ju st going to state that for
9
Let's look at num ber 85.
10 the record, and go ahead.
10 (Exhibit 85, previously m arked, handed to witness)
11
M S FROST: O nly 66 w as used for b a b y --
11
This is a docum ent that you discussed with
12
M R M AIM ON: This is M oshe M aimon.
12 M r Panatier. W h at is that docum ent?
13
Can w e have an identification o f the docum ent
13
A It's a letter from Joseph Schm idt in Johnson &
14 b y B ates n u m ber?
14 Johnson to a M r J M olnar and M r R M M iller.
15
M R PANATIER: Yeah.
15
Q Now, M r Panatier talked w ith you about some
16
M S FROST: Y eah, I'd be happy --I can read
16 m aterials in the second paragraph, b u t I w ant to talk
17 that.
17 w ith you about the first paragraph o f this docum ent.
18
H appy to do that.
18
W hat is the subject m atter being discussed in
19
(Reporter clarification)
19 this docum ent?
20
Yes, for the record, the docum ent that is
20
A Okay. It describes the W indsor M inerals raw
21 m arked as E xhibit 220 has the B ates num ber -- it has
21 talc subm issions from N ovem ber, 1986, to January, 1987.
22 tw o Bates numbers.
22
Q A nd w hat does it report as the finding
23
The first is J& J0004479. The second is
23 regarding those sam ples?
24 JNJ000065646.
24
A It states:
25
N um ber 21 has also tw o B ates num bers. The
25
"The accom panying table summarizes the
Page 1104
Page 1106
1 first is J& J0004480. The second num ber is
1 am phibole m ineral content o f various talc samples
2 JNJ000065647.
2 su b m itted to date for m ic ro s c o p ic ... [exam ination].
3
M R M AIM ON: For the record, those prefix for
3 T h e counts p e r slide w ere ob tain ed b y ... dispersion
4 B ates num ber series w ere n o t am ong the production to us 4 sta in in g ... on acid-w ashed sam ples. Few acicular, and
5 in this case. So I ju st w ant to note that.
5 no fibrous forms, were observed".
6
M S FROST: A nd which case are you referring
6
Q W hat is the significance o f that finding as it
7 to, Mosh?
7 relates to the W indsor M ineral raw talc submissions
8
M R M AIM ON: The Lanzo case.
8 during that tim e period?
9
(Reporter clarification)
9
A As describing them as no fibrous forms, they
10
The production o f documents in New Jersey
10 are suggesting and indicating that there w as no
11 w e re u n d er differen t B ates ranges.
11 asbestos in those sam ples.
12
(Reporter clarification)
12
M R PA NATIER: W hat w as the date?
13
M r Frost is on the line. H e can confirm
13
THE W ITNESS: January 30,1987.
14 that.
14
M R PANATIER: Thank you.
15
M R PANATIER: Just for the record, these
15 B Y M S FRO ST:
16 docum ents w ere indisputably n ot produced to us and
16
Q I think w e have one m ore before we get back to
17 th ey're n o t in the B ates ran g es th at w ere pro d u ced to
17 a m ore linear discussion.
18 u s, n o r w ith the B ates num bers th at w ere pro d u ced to
18
Num ber 155, which you discussed yesterday
19 US.
19 w ith M r Panatier.
20
These are clearly from the ovarian
20 (Exhibit 155, previously m arked, handed to witness)
21 production.
21
W hat is the date on num ber 155?
22
M S KAGAN: W hich w e were told was not
22
A January 14,1975.
23 relevant.
23
Q A nd w hat is that document?
24
M R PA N A T IE R : O kay. A ll right. L et's go
24
A It's a letter on W indsor M inerals letterhead.
25 ahead.
25 The author is V ernon Zeitz, M anager o f Research and
13 (Pages 1103- 1106)
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1 Developm ent --
1 hospitals, surgical swabs, and basically medical
2
Q A nd--
2 ingredients that are used in operations.
3
A --to R oger M iller, also at W indsor M inerals.
3
Q W here w as it located?
4
Q During this tim e period, was there a
4
A In N ew Brunsw ick, State o f N ew Jersey.
5 relationship betw een W indsor M inerals and Johnson &
5
Q Has it always been head quartered in New
6 Johnson?
6 Brunswick?
7
A Yes. Yes, W indsor M inerals w ere supplying talc
7
A In that location, yeah, in the area.
8 to Johnson & Johnson.
8
The facility has m oved slightly over the
9
Q Now, I believe you spoke w ith M r Panatier about
9 years, but within the State in that area, yes.
10 the sam ples being subm itted, including both industrial
10
Q A t what point did Johnson & Johnson get into
11 m inerals, w h ich w e re id en tified as G I, a n d W indsor,
11 the b u siness o f m aking b a b y pow der?
12 w hich is identified as W I, and the ores in the cosm etic
12
A It was one o f those things that occur just as
13 p roduction, w h ich is HC.
13 th ey occur.
14
B ut the thing that you didn't discuss w ilh
14
The products w hich were sold as adhesive
15 h im is the co n clu d in g paragraph.
15 plasters, so m etim es quite large, m aybe four inches b y
16
Can you tell us what the concluding paragraph
16 five inches, w ere sold, and som e people w ould react to
17 rep o rts in co nnection w ith the ev alu atio n o f the
17 the strong adhesive.
18 m inerals?
18
So a doctor wrote to the Johnson company in
19
A It relates to industrial in addition, but it
19 the early 1890s and suggested that he'd found that if
20 states very clearly:
20 you added a little bit o f high grade talc to the area
21
"In conclusion it can be stated with a
21 w here the adhesive m aterial had been rem oved, it would
22 greater than 99.9% certainty that the ores and
22 be tender on the skin and w ould protect the skin.
23 m aterials p ro d u c ed from the ores a t ... [the] W indsor
23
Certainly back in the day, I guess that
24 M ineral locations are free from asbestos or asbestiform 24 adhesives were m uch stronger than they are now.
25 m aterials".
25
So it was a w ay o f soothing the skin, and he
Page 1108
Page 1110
1
Q W hat is the significance o f that report, from
1 thought it w as a good idea, and so Johnson started to
2 your perspective?
2 send out little tins o f this Italian talc powder with
3
A It w ould certainly indicate that the m ine was
3 boxes o f adhesive plaster material.
4 producing clean m aterial, free from asbestos.
4
Q So in the talc business starting in the 1890s?
5
Q Y ou m ay set that aside, please.
5
A I believe about 1894.
6
Let's take a five m inute break. I'll get all
6
Q W hen it begin in the business o f selling baby
7 m y stuff-organized.
7 pow der in 1984, from w here did it source the talc?
8
(O ff the record at 11:05 am)
8
A From the records that I've seen, it w as
9
(O n the record at 11:12 am)
9 originally sourced from the sam e Italian m ine we've
10 B Y M S FR O ST :
10 spoken about from Italy from the V al C hisone valley.
11
Q D r Hopkins, you introduced yourself to the
11
Q W hat are the years that the com pany used the
12 ju ry , an d w e'v e g iv en th em a n un d erstanding o f y o u r
12 talc from the V al C hisone valley in Italy?
13 b ack ground, b ut on e o f the o th er th in g s I w o u ld like to
13
A It was the m ain source up until during the war,
14 d o is to introduce Johnson & Jo h n so n to the ju ry .
14 1941, b ut there w ere exam ples o f a dom estic talc used
15
W hen was Johnson & Johnson founded?
15 a t certain tim es.
16
A A long time ago. From w hat I can understand,
16
There w ere political difficulties in the US
17 aro u n d ab o u t 1878.
17 in the D epression, and w e found that there've been
18
Q A nd w hat was the origin o f Johnson & Johnson?
18 cases w here the talc w as sourced from -- ju s t described
19
A The origin w as actually as a surgical dressings
19 as "dom estic", possibly Californian.
20 m anufacturer.
20
B ut during the war, talc shipments from Italy
21
Q W hat does that m ean for us Am ericans?
21 w ere being delayed or sunk, and so there w as a m ove
22
A W ell, actually, it's an A m erican term .
22 towards using again w hat is described as "domestic
23
Surgical dressings related to simple things
23 talc" for som e period o f tim e in the 1940s.
24 like what later became Band-Aid or adhesive plaster
24
Q S o from the 1890s u p to ro u g h ly W orld W ar II.
25 that goes on the skin, but also for use by surgeons in
25 The source o f Italy?
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1
A M ainly Italy w ith a little bit o f exception.
1
Q W hat is the grade from the m ine in China?
2 T here's som e indication that dom estic talc w as being
2
A It's given the title J200.
3 used probably som e tim e in the 1920s, probably during
3
Q W e've been talking an aw ful lot about talc.
4 the tim e o f the Depression.
4 W hat exactly is talc?
5
Q And then after W orld W ar II, what is your
5
A It's a m ineral. It's m ined underground, and,
6 understanding o f the source o f the talc?
6 as w ith all minerals, it has a chem ical composition,
7
A W ell, after W orld W ar II, shipm ents from Italy
7 and chem ists w ould describe it as a m agnesium silicate.
8 were getting through with no problem , and from then on
8
Q M agnesium silicate?
9 it w as used in Johnson's B aby Pow der and other baby
9
A Yes.
10 products, other products until approxim ately 1968.
10
Q In term s o f softness or hardness, where does
11
Q W hat happened in 1968 to cause the com pany to
11 talc lie on the - so rt o f the scale o f so ft to hard?
12 cease u sing th e Italian talc a n d m o v e to a different
12
A Okay. W ell, scientists rate m aterials from
13 source?
13 very h a rd to v e ry so ft on a scale. So ju s t about the
14
A W ell, at that tim e, the com pany had validated a
14 hardest m aterial know n to science is diam ond.
15 dom estic source o f talc from a m ine in the S tate o f
15
B ut at the other end o f the scale the
16 V erm ont, w h ich w as ow n ed b y the com pany, an d th ey had 16 m aterial talc is p retty w ell one o f the softest
17 q u alified it to use a g rade o f talc w h ich w as later
17 m aterials know n to science.
18 k n o w n a s G rade 66, a n d th at approved g rade w a s used
18
Q D oes talc com e in different varieties or types?
19 instead o f im porting from Italy.
19
A Yes. Yes. It depends on the m ine and the
20
Q Now, the type o f talc that was used from Italy,
20 geology, and that's w hy, w hen you're looking for
21 y o u ju st m entioned the W indsor 66 Grade.
21 cosm etic talc, you're looking for a product that m eets
22
W as there a specific grade o f talc used by
22 the requirements o f cosmetic talc, in softness and
23 Johnson & Johnson in connection with its baby powder 23 platiness.
24 products that it received from Italy?
24
Q W e've talked about softness o f talc. W hat does
25
A Yes, right the way through it always described
25 that actually m ean in terms o f texture or usage?
Page 1112
Page 1114
1 as "five zeros", w hich is 00000 talc.
1
A Sim ply, the p o int o f talc is you pu t it on y our
2
That was the grade that was used from Italy.
2 skin. It should feel soft.
3
Q Y ou said that there had been a m ine qualified,
3
W ords like "silkiness", "lubriciousness" --
4 if I understood your term inology.
4 those w ords are u sed to describe how it feels on the
5
W hat do you m ean by that in connection with
5 skin.
6 the change from the Italian m ine to a second m ine?
6
Q W hat does "lubriciousness" m ean?
7
A Yeah. The m ine in the State o f V erm ont was,
7
A It's a lo v ely w o rd , isn 't it?
8 obviously, w hen you open a new m ine, it takes tim e to
8
Q It is.
9 ensure that the quality o f the talc is the kind o f
9
A It m eans oily alm ost. A lm ost like a lubricant.
10 grade that you're looking for and w ill m eet the
10
It h as th a t v e ry soft, o ily feel w h e n it's
11 sp ecification yo u req u ire in term s o f its feel its
11 p la c e d o n th e s k in a n d r u b b e d o n th e sk in .
12 platiness, freedom from un w an ted m aterials.
12
Q I'm g o in g to h an d y o u w h a t I have m ark ed as
13
So that's part o f the m ine qualification.
13 E x h ib it 222.
14
Q W e'll talk about the m ine process in a little
14
(E xhibit 222 m arked for identification)
15 b it m ore detail shortly.
15
W hat is that?
16
But how long did the com pany use the Verm ont
16
A It's a p ile o f rock. It lo o k s like talc. It
17 m ine as the source fo r the talc th at it u se d in b ab y
17 certain ly looks lik e talc.
18 p o w d er a n d its o ther cosm etic b o d y pow ders?
18
W h en talc is first m in ed , it's b ro k en d o w n
19
A From approxim ately 1968 to about 2003.
19 into baseball, tennis ball size pieces, and this is
20
Q A nd w hat did it do in 2003?
20 w h at talc looks like w hen it first com es out o f the
21
A There w as another m ine source qualified, which
21 m in e an d is b ro k en d o w n in to ten n is b all size pieces.
22 has tended to be used globally. N ot just for Johnson & 22
Q C an you turn that around?
23 Johnson in the U nited States, but in AsiaPacific
23
M ad am V ideographer, can y o u get that, or is
24 countries and in Europe, and the grade m oved to a very 24 it to o fa r aw ay?
25 sim ilar high purity grade from a m ine in China.
25
V ID EO G R A PH E R : I can try ...
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1
Okay.
1 free o f asbestos. T hey're generally very w hite in
2
M S FRO ST: G ot it?
2 color, very pure.
3
Q A nd i f you'll turn to the second page, w hat
3
Industrial grades, as I said before, talc is
4 does that show?
4 a m agnesium silicate, but there are other m agnesium
5
A W ell, that shows w hat talc looks like under a
5 silicates that are found and they can quite
6 m icroscope. It's a general field, a high field, so it
6 legitim ately be used in industrial grades o f talc.
7 shows the talc particles w hich are recognized to have
7
Q Y ou m entioned that talc can be used in certain
8 w hat we describe as a "platy structure". They look
8 fo o d stuffs. A re y o u fam iliar w ith the F D A 's
9 like little side plates, dinner plates.
9 determination o f the use o f certain food products as
10
Q Can you turn that around? Can you point to
10 being safe?
11 w h a t you're talk in g about so th at the ju r y can see?
11
A Yes, I am, yes.
12
So it's the --
12
Q Can talc be used in foods based on its safety
13
A In its crystal structure, it's the one this
13 a n d th e recognition o f its safety?
14 side. T hat's a b ro a d view o f w h at a group o f talc
14
A W ell, providing the talc quality specification
15 p articles lo o k like u n d er a m icroscope.
15 m eets the F D A standards, it is allow ed to be u sed in
16
If you raise the m icroscopic field to get a
16 food contact m aterials sold in the U nited States, and
17 h ig h er po w er, y o u can g e t a pictu re o f w h a t on e o r tw o
17 indeed in other countries.
18 talc particles lo o k like.
18
Q W hat sort o f standards does the FDA have for
19
Essentially, w e describe them as "plate-like"
19 talc for use in foods?
20 or "platy".
20
A The FD A has a specification w hich describes the
21
Q A fter it is ground, w hat does it look like?
21 quality o f the talc.
22
A W ell, after it's ground, it has the appearance
22
It describes the param eters or features such
23 that w e described a m inute ago o f little plate-like
23 as whiteness, fineness, freedom from certain materials,
24 particles.
24 including freedom from asbestos materials.
25
Q Are there uses for talc other than for baby
25
Q I'm going to hand you w hat I have m arked as
Page 1116
Page 1118
1 powder?
1 Exhibit 223.
2
A Yes, talc has long been used as an industrial
2
(Exhibit 223 m arked for identification)
3 m aterial. In fact, I believe approxim ately at least
3
Can you tell us w hat that is?
4 90, 92 per cent o f the talc that's m ined around the
4
A It's a definition o f w hat are called "GRAS
5 w orld is used in industrial applications, and some o f
5 substances". G-R-A-S.
6 those include, o f course, paper. It's a filler in
6
Q A nd w hat is a GRA S substance?
7 paper that w e use.
7
A A GRA S substance is a term used within the
8
It's used in used in autom atic tires as a
8 U nited States and it's kind o f adopted elsew here around
9 filler w ith the rubber. It's used in som e packaging
9 the world. It stands for G enerally Recognized As Safe.
10 m aterials. It's used in roofing m aterials for the
10
Q A nd looking at num ber 223, w hat does this tell
11 ro o fin g m aterial th at goes on m any roofs. It's also
11 u s ab o u t w h a t the F D A has concluded about talc an d its
12 u se d in a nu m b er o f other applications.
12 use as a generally recognized safe substance?
13
Food, for exam ple -- certain foods are
13
A It states that it is recognized under a certain
14 perm itted to have talc added to them . I believe it's
14 rep o rt from 1979 as approved as a G R A S substance.
15 in ch ew ing gum , a n d in som e countries rice is treated
15
Q A nd if w e look at the bottom o f the page on
16 w ith talc to p re v en t it stick in g together.
16 page 1 o f E xhibit 223, w here it talks about definitions
17
Q Let me stop you there.
17 o f labels, can y ou read fo r us, please, w hat the FD A
18
Is there a difference in the uses o f the
18 has said in connection w ith the G enerally R ecognized As
19 industrial talc that you've been describing and
19 Safe characteristics o f various products, not ju st
20 cosm etic talc?
20 talc?
21
A Yes.
21
A Yes. A Generally Recognized A s Safe substance
22
Q H ow is it used in cosm etic talc?
22 is defined as:
23
A W ell, the cosm etic, and som etim es w e talk about 23
"A food substance that is not subject to
24 cosmetic or pharmaceutical talcs, are o f a very high
24 prem arket review and approval by FD A because it is
25 grade, and in fact one o f the requirem ents is they're
25 generally recognized, by qualified experts, to be safe
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1 under the intended conditions o f use".
1 if asbestos were present, it w ould be shown up by the
2
Q W e've talked about the use o f talc in baby
2 evaluation that was done from approxim ately 1946
3 pow der going all the w ay back to the 1890s.
3 onwards. That w as a m icroscopic examination.
4
In the tim e that Johnson & Johnson has been
4
Q L et me hand you w hat I have m arked as Exhibit
5 m anufacturing baby powder, w hat has been the form ula or 5 224.
6 the com ponents o f the baby powder?
6
(Exhibit 224 m arked for identification)
7
A Baby pow der comprises typically 99 per cent
7
W hat is this document?
8 talc pow der with a sm all trace o f fragrance.
8
A It is a specification, and a specification is a
9
Historically, there was addition o f other
9 description o f w hat a product should look like, feel
10 ingredients. O ne that's com e to light is a m aterial
10 like and the chem ical and various physical features o f
11 c alled sodium sesqui citrate, w h ich is a -- it's
11 th a t product.
12 actu ally used as a food additive; it's ad ded in table
12
And this relates to powdered talc used by
13 sa lt to stop salt from clogging in the little holes
13 Jo h n so n & Johnson.
14 w hen you invert your salt on your food.
14
Q Okay.
15
Q W hat was the point o f using it in baby powder.
15
A nd w e've talked a little bit about
16
A Essentially, basically, to stop any baby powder
16 specifications over the last few days, but w hat is a
17 fro m clogging in the little holes.
17 specification and w hat is the significance o f having a
18
Q Does Johnson & Johnson still use sodium sesqui
18 specification th at relates to a raw product?
19 citrate in th e u se o f b ab y pow der?
19
A A specification describes w hat a product should
20
A No. It was something that was done just for a
20 look like, feel like and any chem ical studies that you
21 few years, b ut I think it w as discontinued m any, m any
21 do on it.
22 years ago.
22
So, for exam ple, it describes it as:
23
Q As it relates to the baby powder, has Johnson &
23
"... a very fine, w hite pow der, free from
24 Johnson historically done anything to test the powder
24 g rittin e s s..."
25 for m inerals that w eren't talc, w hether w e're talking
25
So if you received from the factory or from
Page 1120
Page 1122
1 about asbestos or som ething else?
1 the m ining site a dark brow n pow der w hich felt gritty,
2
A W ell, w hen you evaluate baby powder by
2 that clearly w ould not m eet the specification.
3 techniques such as x-ray diffraction, you can determine
3
A nd w e can look at other features o f the
4 if there are other m inerals present.
4 specification, such as the w ater content or its
5
You w ould pick those up if they were present.
5 solubility in acid, or how fine it is.
6
Q W hy would you not w ant other m inerals present
6
So those are all described on the
7 in the baby powder?
7 specification to ensure that w hen you receive a product
8
A For two reasons. One, they may have properties
8 from the m ine or from the factory, the sam e product is
9 that were unpleasant on the skin and didn't feel good;
9 the sam e every tim e and it m eets the quality required.
10 and, tw o, they m ay be harm ful o r toxic.
10
Q W ould it be fair to say that a specification is
11
So you basically try to avoid any material
11 u se d to ensure th at a sup p lier is providing to the
12 th a t is unw anted, e ith e r b ecause it's harm ful o r
12 purchaser the product th at it w ants to buy?
13 d o esn 't feel g o o d o n the skin.
13
A It is. The specification is generally agreed
14
Q Y ou m entioned earlier lubricity. H ow does
14 betw een the purchaser and the supplier.
15 n on-talc m ineral affect the lu bricity o f the baby
15
The supplier is advised: this is w hat we
16 powder?
16 w ant. A nything you send to us should m eet this
17
A If you have particles that are, for example,
17 specification.
18 needle-like, sharp o r granular, th ey w o u ld n o t give
18
Q N ow the docum ent that w e are looking at, num ber
19 th at nice silky, sm ooth feeling. It w ould feel like
19 224, w hat is the date on the docum ent?
20 rubbing sandpaper on your skin.
20
A The date on this particular version is
21
Q H ow long has Johnson & Johnson been evaluating 21 F ebruary 2 2 ,1 9 5 5 .
22 the talc in its baby powder to determine w hether there
22
Q N ow , attached to it there are som e other items
23 is any additional m ineral or contam inant in the ore?
23 that appear to have an earlier date.
24
A Looking back through the records, the oldest I
24
W hat are the m aterials that are attached to
25 could find was one w hich has a cover note stating that
25 Exhibit 224?
17 (Pages 1119-1122) Priority-One Court Reporting Services Inc. - A Veritext Company
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Page 1123
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1
A This is a guide, w hich is dated A ugust 14,
1
A It's a picture o f three types o f com m ercial
2 1946, from a book, and this gives guidance to the
2 asbestos, crocidolite, am osite and chrysotile.
3 people evaluating the specification as to w hat talc
3
Q I f you would, please, flip that around and
4 should look like for cosm etic purposes, and indeed w hat 4 let's show that to the jury.
5 it should not look like for cosmetic purposes.
5
How does that differ from the plate-like
6
So there are several photographs here.
6 version o f the talc?
7
Q Does it provide anything in this specification
7
A W ell, clearly, each o f those different types o f
8 that relates to the presence o f asbestos or other
8 asbestos are needle-like in structure. They look like
9 m inerals?
9 needles.
10
A It doesn't m ention the w ord "asbestos" back in
10
Q A nd I'm going to hand you back the previous
11 1946, b u t as an alternative it u ses the term
11 v iew o f talc.
12 "acicular", A -C -I-C -U -L -A -R , a n d th at is the L atin nam e 12
Can you hold those up together?
13 fo r a needle.
13
A So the talc is the classic plate-like structure
14
So it's saying th at there sh o u ld n o t be any
14 under the m icroscope, w hich is clearly very different
15 needle-like crystals present.
15 from n eedles u n d e r the m icroscope.
16
Q W ould an acicular fiber include asbestos, or
16
Q Okay. Y ou can set those aside.
17 w o u ld it n o t include asbestos?
17
To your knowledge, has Johnson & Johnson ever
18
A Asbestos w ould be - fall under the heading o f
18 b een in the b u siness o f selling asbestos?
19 a n acicular fiber.
19
A No. J& J has never sold asbestos.
20
Q Based on your review o f the documents, how far
20
Q Has Johnson & Johnson ever been in the business
21 b a ck does the req uirem ent to b e free from acicular
21 o f selling products to w hich they intentionally added
22 fibers extend?
22 asbestos?
23
A W ell, w ith the cover note I've seen for this
23
A No, Johnson & Johnson has never been selling
24 Exhibit 224, it described it as being relevant from
24 products with intentional addition o f asbestos.
25 1946 onwards.
25
Q The 1946 and 1955 specifications that we were
Page 1124
Page 1126
1
Q So since at least 1946, Johnson & Johnson has
1 talking about, did those specifications go specifically
2 been evaluating the talc it received from its supplier
2 to health-related issues, or were they developed in
3 to determine whether it m et the specification to be
3 connection w ith broader concerns concerning the talc
4 free from acicular particles or not; is that correct?
4 and the baby pow der products?
5
A That is correct, yes.
5
A T hey w ere developed to ensure that the quality
6
Q And w hat is the significance o f that from your
6 o f the talc m et the requirements o f the company.
7 perspective as it relates to the purity o f the baby
7
W e said earlier that the talc should be free
8 pow der over tim e?
8 from unw anted m aterials; that it should feel sm ooth and
9
A It m eans that, certainly since 1946, probably
9 silky on the skin.
10 ev en earlier, i f yo u 've taken talc from the 000 0 0 m ine,
10
So certainly by avoiding what we described as
11 th e talc w o u ld n o t contain asbestos.
11 needle-like structures, th en you 're n ot going to g et
12
Q Is talc acicular?
12 that unpleasant, prickly feeling on the skin.
13
A No, talc is platy in structure. It looks like
13
Q As part o f your work as an employee and then as
14 little -- little d in n er plates.
14 a consultant on the safety issues for the com pany, are
15
Q Now , you show ed us the pictures o f talc and the
15 y ou fam iliar w ith the quality control testing that
16 dinner plates.
16 Johnson & Johnson perform ed on the talc that it used?
17
How does asbestos look if you see it under a
17
A Yes, I am, yes.
18 m icroscope?
18
Q If you would, give us ju st a short overview
19
A Generally, there are different kinds o f
19 about the steps that J& J took to ensure the talc it
20 asbestos, but generally they all have a very sim ilar
20 used w as free o f asbestos, and then we're going to talk
21 appearance under a m icroscope. T hey look like needles. 21 about those various steps in som e detail?
22 Very, very different from the plate structure.
22
A Okay.
23
Q Let me hand you what I have marked as 225.
23
W ell, the first part is to ensure that the
24
(Exhibit 225 m arked for identification)
24 m ine from w hich the talc is obtained is not going to
25
W hat is this?
25 allow contam ination o f the product with asbestos. So
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1 to ensure that the quality o f the ore coming out o f the
1 company.
2 m ine is talc that m eets the cosm etic pharmaceutical
2
A nd he w as involved in co-ordinating m any
3 grade.
3 approaches, dealing w ith geologists, dealing with
4
Then the next stage is to examine the quality
4 outside agencies, dealing w ith regulators, dealing with
5 o f the talc after it's been taken from the m ine, ground
5 facilities w ho w ould evaluate the talc.
6 dow n into the fineness that you require for body
6
A nd one o f his roles was to regularly visit
7 powders, and then going into packaging, being cleaned
7 talc facilities to ensure that the m ine was doing what
8 up and ready for sale.
8 w as required o f them.
9
So there are two issues there. One is to
9
I do rem em ber he w ent to the China m ine many,
10 ensure the m ine is clean; and then ensure the product
10 m any years ago to help open that up and help qualify
11 is clean.
11 it.
12
Q Let's talk first about the m ines.
12
He visited the Verm ont m ine in Italy and --
13
You said that the m ines had to be evaluated,
13 sorry, the V erm ont m ine in the U n ited States --an d the
14 an d you used the w ord "qualified" earlier.
14 m ine in Italy.
15
W hat steps did Johnson & Johnson take to
15
So he was a regular visitor to w ork with the
16 evaluate a m ine?
16 people and ensure that they produced the kind o f
17
A W ell, w e've alluded to som e o f that in the past
17 product that Johnson & Johnson required.
18 hour.
18
Q N ow , w e've talked about the m ine in Italy and
19
It's im portant to get the involvem ent o f
19 the m ine in V erm ont and the m ine in China.
20 expert geologists to look at what's going on in the
20
D id Johnson & Johnson ever evaluate any other
21 m ine, to look at the type o f talc that's available in
21 m ines that it concluded didn't m eet its qualifications
22 the m ine, and to look at m aterials that you don't w ant
22 for use in the baby pow der product?
23 in the m ine to ensure that they can be avoided by the
23
A W ell, the w ay that that was done w as that,
24 miners.
24 certainly once Professor Pooley had reported on the
25
So that's part o f the qualification o f the
25 Verm ont m ine and the Italian mine, a program was
Page 1128
Page 1130
1 mine.
1 considered and set in place to look at the talc that
2
W hen you look at the quality o f the talc, you
2 was being used by non-US affiliates around the world.
3 look at it by the best scientific techniques available,
3
T hat was an international program done on a
4 look at it m icroscopically, w ith x-ray diffraction,
4 regular basis to ensure that the talc that w as being
5 scanning m icroscopy, and whatever other techniques
5 used m et the same quality standards as in the United
6 you've got to ensure that the product is pure.
6 States, w hether talc w as sold in Philippines, in
7
Q How did Johnson & Johnson go about that process 7 England or India.
8 o f determining whether the talc was pure in the ores
8
So there was a regular audit o f the product
9 from which it obtained its talc?
9 that was being used in those countries.
10
A By involving outside expert geologists. A s
10
Q Did M r Ashton ever evaluate mines or products
11 w e 'v e alluded to earlier, C olorado School o f M ines w ere 11 a n d conclude th at th ey w eren 't a fit for Johnson &
12 involved w ith the V erm ont m ine and later, in 1972,
12 Johnson?
13 P ro fessor P oo ley fro m the G eology D epartm ent o f the
13
A N o, he never actually had to do that.
14 U niversity o f W ales w as also involved in the V erm ont
14
The m ines that were being used m et at the
15 m in e review .
15 tim es those quality standards required.
16
Q You spoke over the last several days about a
16
Q W e talked about the change from Italy to
17 g entlem an b y the n am e o f B ill A shton. W hat
17 V erm ont. W hy w as it th at Johnson & Johnson m ade the
18 involvem ent, i f any, d id M r A sh to n have in evaluating
18 decision in the late 1960s to change the source o f its
19 m ines to determ ine w hether they w ere appropriate for
19 ore from V al C hisone in Italy to V erm ont?
20 use by Johnson & Johnson?
20
A I've never actually seen the w ritten records.
21
A W ell, M r Ashton was a senior scientist in
21 M y understanding, having spoken to M r Ashton, is that
22 Johnson & Johnson. W e called him "M r Talc".
22 taking a dom estic source from Verm ont and packing it in
23
H e'd been em ployed from approxim ately 1950
23 the State o f N ew Jersey is a lot easier than shipping
24 until he retired as a consultant, I think about the
24 m any thousands o f m iles from Italy.
25 year 2003. So he had a long history o f talc in the
25
It w as a case of: w e have a good m ine nearby,
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1 let's use that.
1
Q I'm going to hand you w hat I have m arked as
2
(Reporter requested phones to be m uted)
2 226.
3
Q L et's m ove, then, from the question o f how
3
(Exhibit 226 m arked for identification)
4 Johnson & Johnson qualified a m ine, and let's talk
4
Can you tell us w hat is this?
5 about the testing that it did o f the ore -- hang on a
5
A It's a letter from a Johnson & Johnson employee
6 second?
6 w ith the Baby Products Com pany to another Johnson &
7
M R PANATIER: Hey, folks on the phone --
7 Johnson employee.
8
M S FRO ST: Yeah. W hoever's on the phone,
8
It's dated M ay 4, 1977, and the subject is
9 please put your phone on m ute. W e're getting feedback
9 W indsor 66 Talc Specification, Proposed Asbestos
10 from one or m ore o f you.
10 R equirem ents.
11
Q W e'll try that again.
11
Q Let me stop you there.
12
A Okay.
12
This is a 1977 letter, but did Johnson &
13
Q Y ou m entioned that, in addition to evaluating
13 Jo h n so n have a talc specification fo r the W indsor 66
14 the m ine and determ ining the purity o f the ore, that
14 m ine prior to 1977?
15 Jo hnson & Johnson also d id testin g -- the subsequent
15
A Yes, it did.
16 product.
16
Q In connection w ith that specification, w hat was
17
So let's break that into tw o parts. First,
17 the expectation for the quality o f the talc received
18 th e ore, a n d th en w e w ill talk ab o u t the finished
18 fro m the supplier a t V erm ont?
19 product.
19
A T hat it should be free from asbestos.
20
W hat did Johnson & Johnson do to test the
20
Q Now, the docum ent that we are looking at here,
21 talc o re itself?
21 num ber 226, it actually uses specifically the w ord
22
A The talc ore w as evaluated by a regular audit.
22 "asbestos", does it not?
23 Initially, obviously, w hen you're developing a new
23
A It does, yes, yes.
24 m ine, you do a lot o f testing to ensure that the
24
Q W as that a new requirem ent in 1977?
25 quality o f the talc m eets the required quality and
25
A T hat particular w ord was relatively new in 1977
Page 1132
Page 1134
1 specification.
1 on the specification.
2
Once the m ine is operating and it's producing
2
Q W ould the specification, prior to 1977, have
3 talc, then the requirem ent then is to confirm that the
3 encom passed m aterials that included asbestos, or w ould
4 talc has not changed as you progress through the mine.
4 it not have?
5
So there was a regular audit on the talc
5
A It w ould have included, to ensure that the
6 that's been produced from the m ine. That's a m ine
6 product was free from asbestos prior to this document.
7 audit.
7
Q B ased on your review o f the materials, w hy was
8
Q W as there ongoing testing that perm itted
8 it that Johnson & Johnson changed the wording during
9 Johnson & Johnson to evaluate the quality o f the talc
9 the tim e period 1977?
10 ore from the m ines that it used as -- w as provided by
10
A M y understanding, and speaking to people, was
11 its suppliers?
11 to en su re th at there w as absolute clarity and
12
A There w as a program , or is still a program , to
12 clarification betw een the m ine and the purchaser,
13 evaluate th e ore o n a qu arterly basis. So that, as yo u
13 Jo hnson's B aby P roducts, th at the products should be
14 progress through the m ine, that is confirm ed on a
14 free from asbestos, and used the w ord "asbestos",
15 q u arterly b asis th at th e m ine is still pro d u cin g the
15 rath er th an an y o th er w ord, such as "acicular". It
16 co rrect grade o f talc.
16 m oved from acicular to clearly stating asbestos.
17
Q W hat's the significance o f the grade o f talc?
17
Q W hat was the frequency o f the testing that was
18
A W ell, the grade o f talc, as w e've talked about
18 associated w ith the evaluation o f the W indsor 66
19 in the --w hen w e use the w ord "specification", relates
19 m aterials?
20 to its purity, its w hiteness, its softness, feel on the
20
A M y recollection is that that testing was done
21 skin, and absence o f unw anted m aterials and m inerals.
21 quarterly to evaluate as it progressed through the
22
Q Did Johnson & Johnson have a specification for
22 m ine, that on a quarterly basis the product still m et
23 the W indsor 66 talc, specifically?
23 the requirem ents to be free from asbestos, and indeed
24
A Yes. There's a separate specification for that
24 m et the other quality specifications.
25 talc.
25
Q W hat other quality specifications were there?
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A There's quite a long list.
Page 1135
Page 1137 1 control, the regular quality control, as a check on the
2
It lists the m axim um am ount o f moisture you
2 pow der before it's shipped for filling.
3 can have. It describes the m icroscopic structure, free
3
Q W hen did Johnson & Johnson begin to test baby
4 from m aterials that are unw anted and platy-type, it
4 pow der and Show er to Show er products?
5 describes its bulk density, it describes its color,
5
A In the talc form , certainly in the '60s, '70s,
6 fineness, m axim um limits for heavy m etals, and the
6 it was part o f the process specification.
7 am ounts o f w ater soluble iron.
7
Q W ere there standard methods that Johnson &
8
So there's a long list o f quality
8 Johnson used for its testing o f the talc?
9 descriptions that the product should meet.
9
A Yes, and over the years those methods developed
10
Q W e keep talking about w hether or not there is
10 as science and technology im proved and various m ethods
11 asbestos in talc a n d specifications th at th ere n o t be
11 have b een used.
12 a n y asbestos o r acicular particles o r anything o f th at
12
Q M ore specifically, did Johnson & Johnson have a
13 nature in th e talc.
13 standard m eth o d for testin g talc specifically for
14
W hy w ould one be concerned about the
14 asbestos?
15 ex istence o f those m aterials in co n junction w ith talc?
15
A W ell, originally, yes, back in the 1960s it
16
A W ell, i f those m aterials w ere present, if there
16 w ould have been optical m icroscopy, and certainly a
17 w ere asbestos m aterials present, th en it w o u ld be
17 com petent optical m icroscopist can see i f there's
18 d escrib ed a s n o t m eeting the specification.
18 asbestos presen t u n d er a g o o d m icroscope i f y o u look at
19
A nd certainly at that tim e, people were
19 enough slides.
20 beginning to be aware that the quality o f talc should
20
Then going forward, you can look at some of
21 be asbestos free.
21 the other techniques that have been developed, such as
22
Q Can you describe for us the finishing process
22 x-ray diffraction and transm ission electron microscopy.
23 that's associated w ith m aking the talc ore appropriate
23
Q W e keep talking about those terms.
24 to go into a finished baby pow der product?
24
Doctor, I have m arked an Exhibit 226 that -
25
A Yes. K eeping it very sim ple, the talc is talc
25
MS KAGAN: 227.
Page 1136
Page 1138
1 rock, w hich w e see the baseball, tennis ball size
1
MS FROST: 227. Let me have that back,
2 pieces. They're ground dow n to fine particles.
2 please. Thank you.
3
Y ou're aim ing to get as m any o f the
3
(Exhibit 227 m arked for identification)
4 plate-like particles as possible and m inim ize the
4
Both sides have been lucky to have M s Kagan
5 num ber o f sm all, tiny particles that don't give you
5 here to keep us honest on our numbers. W e are looking
6 that nice feel.
6 at num ber 227.
7
So a process is set up called "flotation",
7
Q Just a sort o f orient us, when you are talking
8 w hereby the ground material is placed into a water
8 about these different types o f m achines that do
9 bath, essentially. Bubbling agents or foaming agents
9 testing, I am a visual person, so it's helpful for me
10 are added and the platy talc, the highest quality, the
10 to have som e idea o f w hat it is that you're talking
11 nicest, so ftest talc, rises to th e to p an d sits on the
11 about, an d I th in k th at w o u ld pro bably ben efit the
12 b ubbles at th e top o f the b ath , a n d th at is filtered
12 ju ro rs as w ell.
13 o f f o r taken off, an d an y m aterial th at is n o t o f that
13
Can you explain for us what these different
14 q u ality sinks to the b o tto m a n d is rem oved.
14 m achines you have described look like, and in sort o f
15
So w hat you're aim ing for is as high as
15 sim plified term s w h at is the difference o f w h at th ey 're
16 possible am ount o f the plate-like particles, because
16 looking for?
17 th at's w h a t you 're looking fo r to give the nice, silky,
17
A I m ean, the classic one in the m iddle is
18 sm ooth feel.
19
Q Okay. You can put that one away.
18 optical m icroscopy, and this is a picture o f a very up 19 to date, sophisticated m odel, certainly better than the
20
So w e've now talked about the m ine and the
20 ones I rem em ber from school, and that is a high pow ered
21 ore.
21 m icroscope that allow s you to look at the talc in the
22
Did Johnson & Johnson also test the finished
23 baby powder product itself to determine whether there
22 same way we looked at some o f those pictures today. 23 Y ou can see fine particles.
24 w as any asbestos in the product?
24
But, o f course, technology has moved on, and
25
A Yes. T hat was part o f the regular audit
25 there are other methods. This one is a picture o f a
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1 x-ray diffractom eter, w hich m easures x-ray diffraction,
1 Better? W orse? M ore comprehensive? Less
2 and that scans the talc particles and gives a printout
2 comprehensive? H ow w ould you describe it?
3 o f a num erical reference num ber, and that allows you to
3
A It's m ore com prehensive.
4 define w hat kind o f m inerals are present.
4
The CTFA m ethod requires to do tw o tests.
5
Again, very sim ply, the transm ission electron
5 O ne, ev aluate u sin g x -ray diffraction, an d i f th ere's
6 m icroscope allows you to look for fine, fibrous-like
6 any question, to follow up w ith polarized light
7 particles under the m icroscope.
7 m icroscopy.
8
They have a very, very high sensitivity.
8
The policy in Johnson & Johnson is to go a
9 T hey will w ork dow n to parts per million.
9 step further and have a product evaluated by
10
Q Is the transm ission electron m icroscope able to
10 transm ission electron m icroscopy.
11 g e t d ow n alm o st to a cellular b asis? Is th at w h at
11
Q How often was the talc that was used in baby
12 I understand?
12 p o w d e r an d S how er to S how er tested w ith Johnson &
13
A It will go down pretty well, yes.
13 Joh n so n 's internal testin g m ethods, starting in the
14
The Food and Drug A dm inistration used
14 1970s?
15 tran sm ission electron m icroscopy in th eir au d it o f
15
A The test m ethod was tested every two weeks on
16 products on the U S m arket in 2009, and they claim the
16 sam ples, every tw o w eekly.
17 d etection sensitivity o f .04 p arts p e r m illion.
17
Q W ho perform ed that testing?
18
Q Okay.
18
A Generally, outside consultants.
19
A So it's pretty sophisticated.
19
A s I've said before, expensive equipm ent
20
Q All right. Y ou can put that aside.
20 needs training and expertise in how to use it. So
21
Y ou spoke yesterday, I believe it was,
21 com panies like M cC rone Laboratories, EM Associates wei e
22 although it m ay have been the day before, with
22 used to give an outside opinion as to the quality o f
23 M r Panatier about a very specific testing m ethod called 23 the talc using their equipment.
24 J4-1, and w e looked at w hat is in the record as Exhibit
24
Q Now , w hen w e talk about the cost o f the
25 num ber 162. L et me hand that back to you.
25 equipm ent, you w ould agree w ith me, w ould you not, that
Page 1140
Page 1142
1 (Exhibit 162, previously m arked, handed to witness)
1 Johnson & Johnson could probably have afforded to buy
2
W e're going to talk about that in detail in a
2 its ow n equipm ent; right?
3 m inute.
3
A They certainly could, yes, yes.
4
But in addition to this CTFA m ethod, did
4
Q So w hy didn't they?
5 Johnson & Johnson have any internal testing procedures
5
A W ell, it's relatively inexpensive to have a
6 that included review by the x-ray diffraction, optical
6 scan evaluated.
7 m icroscope and/or transm ission electron m icroscope,
7
B ut the m ain reason, to m y understanding, is
8 like the ones you ju st showed to the jury?
8 that to get a good result and to understand how to use
9
A Yes. A lthough J& J didn't necessarily in the
9 this equipm ent is one that requires expertise and
10 early days have som e o f the sophisticated equipm ent
10 training.
11 in-house, it w a s the com pany's p o lic y to u se outside
11
It's not som ething that I could do. I could
12 ex p erts w h o w ere --h a d ex p ertise in usin g x -ray
12 n o t do th at k ind o f w ork. I can look at an optical
13 d iffractio n a n d transm ission electron m icroscopy.
13 m icroscope. I can lo o k a t things, b u t w h en w e're using
14
A nd it w as the com pany's policy to use this
14 very sophisticated equipm ent, like transm ission
15 p articu lar m ethod, w hich u ses x -ray diffraction,
15 electron m icroscopy o r x-ray diffraction, w e need
16 polarized light m icroscopy and electron m icroscopy.
16 people w ho've got a good experience as to how to use
17
Q Okay. W hen you say "this m ethod", I can see
17 them so that the result is m eaningful.
18 th at you are lo o k in g a t the docum ent.
18
M S FROST: W hy don't w e take a ten m inute
19
Are you looking at num ber 162, w hich is the
19 break? W e've b een going for about an hour.
20 CTFA method?
20
M S FRAZIER: Yeah.
21
A Yes, I am.
21
(O ff the record 12:02 pm )
22
Q Okay.
22
(O n the record at 12:12 pm )
23
If you w ould set that down for a moment.
23 BY M S FROST:
24
W hy don't you tell the jury how did the
24
Q D octor, w e w ere talking about the CTFA J4-1
25 Johnson & Johnson m ethod relate to the CTFA method? 25 process.
22 (Pages 1139- 1142)
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1
Remind us, who is the CTFA?
1
A W ell, Johnson & Johnson actually incorporated
2
A It's the short nam e version for a group, the
2 that standard before the CTFA published.
3 Cosm etic Toiletry & Fragrance A ssociation o f the United 3
CTFA published in 1977. M y understanding is
4 States, and that's a group o f well know n com panies that
4 that J& J were doing those sam e tests certainly a year
5 sell products you'll buy in m ost superm arkets,
5 before then, and probably a little bit longer.
6 Unilever, Johnson & Johnson, Estee Lauder, all those
6
Q W hen you say that you understand that it was a
7 well known names.
7 little bit earlier, w hat is the basis for that?
8
Q The process itself describes the use o f
8
A It's having spoken w ith people within the
9 different technology.
9 com pany w ho said that, because they were involved in
10
W hat processes are required in order to
10 developing the CTFA standard, they w ere getting
11 d eterm ine th e absence o f am phibole m inerals in talc
11 ex p ertise in u sin g those sam e test m ethods v ia their
12 u sin g the J4-1 m ethod?
12 outside external consultants.
13
A The J4-1 m ethod states that the first test you
13
Q D oes the talc used in Johnson & Johnson's Baby
14 should use is x-ray diffraction to ensure there's no
14 Pow der m eet any other specifications?
15 am phibole m in erals present.
15
T hat's p ro b ab ly a v ery p o o r question.
16
Q M r Panatier has asked you several tim es about
16
W e talked -- these are industry standards,
17 th e com parison b etw een u sin g the J4-1 o r on e o f the
17 b u t there are also standards for som ething th at is
18 o th er m ethods and h is use o f a m agnifying glass to try
18 c alled the U S Pharm acopeia; is th at correct?
19 a n d fin d b acteria o n his skin.
19
A Yes.
20
Is that, in fact, an apt analogy in term s o f
20
Q A nd w hat is the Pharmacopeia?
21 h o w one g o es ab o u t finding som ething from a scientific 21
A The Pharm acopeia --we see it as a book, or
22 standpoint?
22 several volum es o f a book, and it describes the quality
23
A N o, I think that's, to be honest, that's
23 o fju st about all the drugs and pharm aceuticals that
24 probably a little bit o f a difficult one to draw a
24 th at you get prescribed to you, or even ju st over the
25 strong analogy.
25 counter.
Page 1144
Page 1146
1
If you look on your skin w ith a
1
So everything from aspirin, acetaminophen,
2 m icroscope slide --
2 right through to anti-virals, antibiotics,
3
Q Why?
3 beta-blockers, heart drugs, just about anything your
4
A --sorry, with a hand microscope, or a hand
4 physician w ould prescribe you.
5 slid, you w ill never, ever see any bacteria. They're
5
But it also includes m aterials that are what
6 ju st w ay too sm all to be seen through Sherlock Holm es'
6 are described as "excipients", so things that go to
7 m agnifying glass.
7 m ake the little white tablets you put in your mouth;
8
If you look at talc under x-ray diffraction,
8 m aterials like cellulose or starch or talc, w hich is
9 you will certainly at some level pick up w hether there
9 also used in those little w hite tablets.
10 is any asbestiform m inerals there, including asbestos.
10
So it describes the quality o f materials that
11
Q Is that because o f the detection lim it
11 go along w ith the drug, as w ell as the actual drug
12 d ifference w ith the m agnifying glass, o r som e other
12 itself.
13 technical d ifference b etw een th e type o f com parison?
13
Q W e've been talking about industrial talc and
14
A It is essentially the detection limit.
14 cosm etic talc. Is there also som ething called
15
A hand m agnifying glass will never, ever pick
15 p harm aceutical grade talc?
16 u p a bacterium o n y o u r skin, w hereas x -ray diffraction
16
A There is. The U nited States Pharm acopeia sets
17 w ill p ick up certain m aterials, su ch as asbestos, in
17 a standard for pharm aceutical grade talc.
18 talc sam ples.
18
Q I have m arked and handed to you a docum ent that
19
Q Even though it has a detection lim it?
19 w e --is num ber num bered 228.
20
A E ven though it has a detection lim it, there is
20
W hat is that?
21 a point at w hich it w ill pick them up, yes.
21
(Exhibit 228 m arked for identification)
22
Q D oes Johnson & Johnson's B aby Pow der and Show e 22
A It is a description o f w hat is the USP.
23 to Shower have to pass the CTFA standard?
23
It describes the US Pharmaceutical
24
A As a basic starting point, yes.
24 Convention, the USP:
25
Q And how long has that been so?
25
"... is a scientific nonprofit organization
23 (Pages 1143 - 1146)
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1 that sets standards for the identity, strength,
1
A Procedure 1 is to evaluate by infrared
2 quality, and purity o f medicines, food ingredients, and
2 absorption.
3 dietary supplements manufactured, distributed and
3
Q W e haven't talked about that. Is that a
4 consum ed worldwide".
4 process that Johnson & Johnson uses to evaluate the
5
Q Does the Johnson & Johnson B aby Pow der and its 5 quality o f the talc?
6 Shower to Show er m eet the standards for pharm aceutical 6
A N o, that's not one that's w idely used.
7 grade talc?
7
It has been used, but as an alternative,
8
A Yes. The U SP standard for pharm aceutical grade
8 Procedure 2, w hich is x-ray diffraction, is the one
9 talc is just about identical to the Johnson & Johnson's
9 that's Johnson & Johnson's initial evaluation.
10 standard for baby pow der talc.
10
A nd Procedure 3, w hich defines if you get a
11
Q A nd I believe M r Panatier asked you about the
11 resu lt in P ro ced u re 1 o r Procedure 2, is to use optical
12 n atu re o f the U S Pharm acopeia.
12 m icroscopy.
13
It is not a governm ental agency. I think you
13
Q W hat is the outcome if the talc passes the USP
14 described it as a quasi governm ental agency.
14 test? W hat is --w hat are the im plications in term s o f
15
W hat did you m ean by that?
15 sales?
16
A W ell, as the U SP heading describes, U SP's
16
A W ell, that talc can be used in pharmaceutical
17 standards are enforceable in the U n ited States b y the
17 applications, and in d eed food applications.
18 F o o d an d D ru g A dm inistration.
18
Q H ow often is the talc used in baby pow der and
19
So a branch o f the governm ent enforces the
19 Show er to S how er tested under the U S P standard?
20 U SP's standards.
20
A U sing the sam e test m ethodologies, batches are
21
Q Does the USP set standards on m inerals other
21 sam pled every tw o weeks.
22 than asbestos that are perm itted to be in
22
Q W e've now discussed the internal testing, the
23 pharm aceutical grade talc?
23 industry standard J4-1, the USP test.
24
A It does, yes, yes.
24
A re those all o f the tests that are done on
25
Q W ell, I have handed you docum ent num ber 229.
25 the final Johnson & Johnson baby pow der product?
Page 1148
Page 1150
1
(Exhibit 229 m arked for identification)
1
A No. Johnson & Johnson takes that seriously and
2
Is that the set o f standards applicable for
2 takes it to the next level and uses transmission
3 the USP?
3 electron m icroscopy as an additional follow up test.
4
A It is, yes.
4
Q In connection w ith that testing, despite the
5
Q A nd I guess standards applicable to talc for
5 m aterials w ritten on the flip-chart by M r Panatier over
6 the USP?
6 the last several days, have you seen any testing from
7
A Talc for the USP, yes, yes.
7 the J4-1 m ethod, the U SP m ethod, the internal testing
8
Q And can you just give us some examples? W hat
8 or TEM to demonstrate that there is asbestos in Johnson
9 else does the USP set limits on in connection with the
9 & Johnson's B aby Pow der?
10 talc?
10
A The answ er to that question is no. I've never
11
A It sets a lim it on the content o f m agnesium , a
11 seen an y resu lt w h ich confirm ed asbestos w as p resen t in
12 lim it o n th e co n ten t o f iron. It sets standards for
12 b aby pow der.
13 th e am ount o f w a ter soluble substances. It sets a
13
Q In addition to the testing that is done by the
14 lim it on the am ount o f led, a lim it on calcium , a lim it
14 com pany, are y ou aw are o f any testing done by
15 o n alum inum , and absence o f asbestos, a n d the m icrobial 15 governm ental agencies regarding Johnson & Johnson talc?
16 quality.
16
A Yes, la m , yes. The classic, well known one
17
Q In connection with the standard for the absence
17 w as the F ood and D rug A dm inistration did a very
18 o f asbestos, h o w does it instru ct th o se w h o are
18 stringent analysis b ack in 2009.
19 com plying w ith the standard to do the testing?
19
Q I have m arked and I'm handing you w hat I
20
A W ell, to quote:
20 believe is 230.
21
"Suppliers o f talc m ay use one o f the
21
(Exhibit 230 m arked for identification)
22 follow ing m ethods to determine the absence o f asbestos. 22
W hat is that, sir?
23 Proceed as directed for Procedure 1 or Procedure 2. If
23
A This appears to be a print-off from the FDA
24 either test is positive, perform Procedure 3".
24 w ebsite relating to talc.
25
Q O kay, a n d w h at is P rocedure 1?
25
Q W hat was the FD A looking for in connection with
24 (Pages 1147- 1150)
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1 talc?
1 either by polarized light m icroscopy nor by
2
A It was looking for quality and purity, and in
2 transm ission electron m icroscopy.
3 particular it expressed that there was interest around
3
Q A nd w hat did they show to be the limit o f
4 the topic o f asbestos, and so they were interested in
4 detection in the m aterials that they are using?
5 exam ining talc to ensure that its quality w as such that
5
A W ell, w ith the very sophisticated methodology
6 it w as safe.
6 o f transm ission electron microscopy, they state that
7
Q Okay.
7 the average lim it o f detection is .0000021 per cent,
8
Looking at the second page o f 230, w hat does
8 w hich translates in parts p e r m illion to .021 parts per
9 the FD A say that it was doing in connection w ith the
9 million.
10 evaluation o f talcum pow ders?
10
Q Looking at that level, did they find any
11
A W ell, w hat is stated is How FDA follow ed up on
11 asbestos m inerals in the o re subm itted b y either R io
12 th e latest reports:
12 T into or L uzenac?
13
"Because safety questions about the
13
A They found no asbestos present in the minerals,
14 p o ssibility o f asbestos in talc are raised
14 no.
15 periodically, F D A d ecided to co n d u ct an exploratory
15
Q Turning over to page 7 w here it reflects body
16 su rv ey o f [the] c u r re n t... m ark eted cosm etic-grade raw
16 pow der, w hat does it show that Johnson & Johnson
17 m aterial talc, as w ell as som e cosm etic products
17 subm itted to be evaluated as p art o f the testing?
18 co ntaining talc".
18
A Yes, it appears to show that Johnson & Johnson
19
Q D id Johnson & Johnson provide sam ples o f its
19 subm itted tw o products, Johnson's B aby P ow der and
20 product for testing by the FDA in 2009 and 2010?
20 Shower to Shower M orning Fresh Body Powder.
21
A They did, yes.
21
Q W hat did the FDA report about the talc that
22
Q Did the supplier for Johnson & Johnson supply
22 they review ed -- the products they review ed for Johnson
23 m aterials for the FD A to review as part o f its testing?
23 & Johnson?
24
A Yes, the supplier provided talc ore materials.
24
A W ell, looking for asbestos by both polarized
25
Q W ould it be fair to say that Johnson &
25 light m icroscopy and transm ission electron microscopy,
Page 1152
Page 1154
1 Johnson's participation on --in this FD A process w as
1 they reported none detected.
2 voluntary, rather than m andatory?
2
M S FR O ST : This is probably a good place to
3
A It was voluntary, yes.
3 break -
4
Q W hy would Johnson & Johnson voluntarily
4
M R PANATIER: Sure.
5 participate in the evaluation o f talc by --at the FDA
5
M S FROST: --fo r lunch.
6 in 2009 and 2010?
6
Let's do a quick lunch if w e can so w e can
7
A I w ould summarize by saying that there was
7 try and get finished.
8 nothing to hide and no fear that the product w ould be
8
(O ff the record at 12:28)
9 found lacking in any way.
9
(O n the record at 12:58 pm)
10
The com pany is very confident in the safety
10 B Y M S FROST:
11 o f its p roduct, a t lea st in term s o f freedom from
11
Q D r H opkins, w e w ere talk in g ab o u t the F D A 's
12 asbestos.
12 evaluation o f cosm etic talc in 2009 and 2010 and their
13
Q W hat sort o f test did the FDA perform , as
13 findings in co nnection w ith b o th Johnson & Johnson's
14 reported in num ber 230?
14 finished products and the ore from w hich they get their
15
A They used a well known contract laboratory and
15 talc.
16 th ey an aly zed sam ples u sin g tw o techniques, p o larized
16
Prior to the 2009/2010 evaluation, had
17 lig h t m icroscopy a n d tran sm issio n electron m icroscopy. 17 Joh n so n & Johnson h a d interaction w ith the F D A
18
Q W hat did they ultim ately conclude concerning
18 concerning asbestos testing that it w as perform ing in,
19 th e rev iew o f m aterials?
19 say, the early 1970s?
20
A They sum m arized their report. They looked at
20
A Yes, there was regular dialogue with FDA and
21 the raw talc, talc that is actually used by Johnson &
21 Johnson & Johnson on m any occasions in the early 1970s.
22 Johnson.
22
Q A nd you talked --I'm handing you num ber 231.
23
Q Is that reflected on page 3?
23
(Exhibit 231 m arked for identification)
24
A That's on page 3, and they reported that in the
24
You spoke w ith M r Panatier about some
25 seven sam ples evaluated, no asbestos was detected
25 interactions w ith the FDA, but I w ant to show you what
25 (Pages 1151-1154)
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1 I've m arked as 231.
1
A That is correct, yes.
2
W hat is this document?
2
Q A nd w hy w as J& J com m unicating this information
3
A It's a letter on Johnson & Johnson letterhead
3 to the FDA?
4 dated Septem ber 21 ,1 9 7 1 . It's from D r N ashed and to
4
A Johnson & Johnson was aware that FDA were
5 D r Schafiher at the Bureau o f Foods, Food and Drug
5 interested in the safety o f talc, talc products, and
6 A dm inistration in W ashington.
6 there had been discussion in the m edia and the press as
7
Q A nd w hat does it claim to do?
7 to w hether or not there m ay be asbestos in talc
8
A W ell, the subject is Johnson's B aby Pow der and
8 products.
9 it's a letter to D r Schafiher at FD A as a follow up
9
So FD A w ere responding to that.
10 from a m eeting w ith FD A on A ugust 3,19 7 1 .
10
Q Okay. You can set that one aside.
11
Q Right. It says on the document:
11
W e talked about the qualification o f the
12
"As w e discussed, w e are subm itting herewith
12 m ines. I w ould also like to talk w ith you about the
13 fu ll reports o f o u r investigations as follow s ..."
13 specific testin g o f the m ines.
14
W hat types o f investigations was Johnson &
14
O ne o f the item s identified in num ber 231 is
15 Jo hnson sharin g w ith the F D A an d the D epartm ent o f
15 a rep o rt fro m D r Pooley, an d w e have talked about D r
16 H ealth E d u catio n and W elfare in '71?
16 Pooley and w hat he found.
17
A W ell, the subject is Johnson's Baby Pow der and
17
I have for you document num ber 232.
18 th e sam ples th at are b eing sh ared w ith F D A are
18
(Exhibit 232 m arked for identification)
19 d escrib ed as:
19
There's a cover page and an attachm ent.
20
Identification o f samples used in the Pooley
20
A Thank you.
21 re p o rt an d the M cC rone report;
21
Q W hat is num ber 232?
22
A letter from the Colorado School o f M ines
22
A N um ber 232, there's a cover page on letterhead,
23 Research Institute;
23 U niversity College, Cardiff, w hich is the U niversity o f
24
A report by Johnson & Johnson Pharmaceutical
24 W ales, from D r Pooley, D epartm ent o f M ineral
25 Research Section entitled "Particle size o f JO H N SO N 'S 25 Exploitation, and that's to D r Shelley at Johnson &
Page 1156
Page 1158
1 B aby Powder";
1 Johnson.
2
A report from D r FD Pooley, University
2
Q A nd w hat do you understand that Dr Pooley did
3 College, W ales, w hich is described as "Report o f
3 in connection w ith his evaluation o f the mine?
4 Investigations o f Talc Sam ples supplied by Johnson &
4
A This is a report w hich in two paragraphs states
5 Johnson"; and, finally,
5 that:
6
Reports from W alter M cCrone Associates (a)
6
"The m ineralogical x-ray and morphological
7 and(b);
7 exam ination o f the Italian mine samples has been in
8
(a) is "M ethodology for the Determ ination o f
8 progress for over a year. The sam ples [which] w ere all
9 Asbestos in Talc; and
9 collected under m y supervision at the Fontana mine,
10
(b) "E xam ination o f B ab y P o w d er for Jo h n so n & 10 w h ic h is the sam e m ine from w h i c h ... 'S how er to
11 Johnson".
11 S how er' sam ple w as obtained".
12
Q Is this roughly all o f the inform ation that
12
A nd he goes on to state that the report
13 w e'v e been d iscussing th is m o rn in g ab o u t the evaluation 13 sum m arizes:
14 o f talc and finished product for Johnson & Johnson?
14
"No chrysotile w as found at the mine or in
15
A Yes, that is m y understanding is the sum total
15 the sam ples taken, som e trem olite w as located, b ut was
16 o f w hat w as available in 1971.
16 n o t asbestiform in character and has n ot been detected
17
Q A nd w hat does D r N ashed say in connection w ith 17 in the 00000 talc im ported into G reat B ritain for the
18 p ag e 2 ? W h at does h e say ab o u t th e ou tco m e o f the
18 past year, n o r in shipm ents dating back to 1949".
19 data?
19
Q D r Pooley attach a report as part o f his
20
A W ell, summ arizing the reports from the five
20 correspondence to M r Shelley?
21 people previously m entioned, he states:
21
A H e does. He attaches a b rief report. It looks
22
"It is seen that the data conclusively proves
22 about six pages.
23 that JO H N SO N 'S Baby Pow der is free o f asbestos".
23
Q A nd w hat type o f sam pling does it indicate that
24
Q W as that what Johnson & Johnson thought in
24 he did in connection w ith the testing?
25 1971?
25
A It's a sam pling o f sam ples from the Italian
26 (Pages 1155 - 1158)
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1 m ine, the basic rocks from different parts o f the m ine
1 spent several days in the m ine, looking at the
2 w here the m ine runs, and also sam ples o f the actual
2 different kinds o f rock in the locality o f the talc
3 talc that w as in the mine.
3 m ining area; looked for types o f rock that are not
4
Q And, again, the conclusion was?
4 m ined, but could well be in the m ine, and also to look
5
A W ell, there's a six page report, but the
5 at the quality o f the talc itself.
6 overall conclusion is that there w as no asbestos
6
Q I have handed you what I have marked as number
7 present.
7 233.
8
Q Y ou m ay set that aside.
8
(Exhibit 233 m arked for identification)
9
The letter talks about the m ine, but it also
9
W hat is that?
10 talk s ab o u t sam ples o f product, d id it not?
10
A This is a report from D r Pooley from the
11
A It did, yes.
11 M ineralogy D epartm ent o f h is university, w h ich is
12
Q W hat was his conclusion about the samples o f
12 described as a R eport o f the E xam ination o f the R ock
13 th e product?
13 S am ples from the V erm o n t M ine.
14
A W hat he stated w as - let's read it exactly.
14
Q Okay.
15
"The data conclusively proves that Johnson's
15
W hat is the date o f this, as best you can
16 B aby Pow der is free from asbestos."
16 tell?
17
Let m e read that again. Let m e read it
17
A It's w ritten --handw ritten, O ctober, 1972.
18 exactly.
18
Q W hat did he conclude after having reviewed the
19
"No chrysotile w as found at the m ine or in
19 V erm ont m ine, i f w e turn over to page 48, w hich is the
20 sam ples taken."
20 last page o f the document?
21
A nd then he goes on to say:
21
A It's a long report. Y es, the conclusions are
22
"Chrysotile w as located, but was not
22 on page 48, yes.
23 asbestiform in character and has not been detected in
23
L et's read th is c a re fu lly ...
24 talc im ported into Britain for the past year, nor in
24
Q Ith in k -
25 shipm ents dating back to 1949."
25
A I think the second paragraph is the key one:
Page 1160
Page 1162
1
Q Chrysotile is one o f the types o f asbestos that
1
"The am phibole m inerals were [not] found in
2 you show ed to the jury on the graphic earlier?
2 [the] discrete locations ... [nor] dissem inated
3
A Yes.
3 throughout the talc ore and w ere not asbestiform ..."
4
Q W as it not?
4
I w ill read that again:
5
So none o f that in the mine?
5
"The amphibole m inerals were found in
6
A H e did not find that in the mine.
6 discrete locations and not dissem inated throughout the
7
Q Likewise, he did not find that in the product.
7 talc ore and w ere not asbestiform in character".
8 Is that correct?
8
Q Let me stop you there. W hat does that mean?
9
A That is correct, yes.
9
A Basically, he found no asbestos in the talc
10
Q H e m entions having looked at som e sam ples going 10 ore.
11 b a ck som e years.
11
Q Okay.
12
How far back did D r Pooley evaluate samples
12
W hat does he say in connection with
13 fo r Johnson & Johnson?
13 serpentine m ineral?
14
A It im plies, w hich is clear from the letter,
14
A "Serpentine m ineral w as found in the specimens
15 th a t he lo o k ed a t shipm ents d ating b ack to 1949.
15 lo cated a t the center o f the o re body b ut n o fibrous
16
Q Okay.
16 com ponents w ere observed."
17
D id D r Pooley also look at the Verm ont m ine
17
Q So what does that mean?
18 fo r Johnson & Johnson?
18
A Again, there was no asbestos in the --in that
19
A Yes, he did a separate audit o f the Vermont
19 particular location.
20 mine.
20
Q A nd that location is the W indsor mine?
21
Q W hat is your understanding o f w hat he actually
21
A This is the actual ore body o f the W indsor
22 did in connection with his evaluation o f the Verm ont
22 m ine, yes.
23 m ine?
23
M R PANATIER: Is that 233?
24
A V ery similar to what he did in the evaluation
24
M S FROST: Yes.
25 o f the Italian mine. Go down the mine. 1 know he
25
Q Now , M r Panatier talked with you about the
27 (Pages 1159- 1162)
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1 various outside consultants, and this m orning we have
1
"Roger M iller o f W indsor M inerals has asked
2 talked about the w ork that D r Pooley did in connection
2 th at I w rite to ... co n firm th at w e have b een u sing
3 w ith the Italian m ine and the V erm ont mine.
3 W in d s o r ... talc fo r a n u m b er o f years."
4
D r Pooley was not the only one who evaluated
4
Q A nd--
5 ore from the Verm ont m ine on behalf o f Johnson &
5
A Canyon.
6 Johnson.
6
Q Pm sorry, I didn't m ean to interrupt you.
7
W ould you agree with m e on that?
7
They've been evaluating the talc for Johnson
8
A That is correct, yes.
8 & Johnson; is that -
9
Q For a very long tim e, Johnson & Johnson
9
A Yes.
10 retained an outside group to do som e ongoing m onitoring 10
"Our first project with W indsor w as opened in
11 o f the talc products, d id th ey not?
11 S eptem ber 1971."
12
A They did, yes.
12
W hich w ould be 16 years previously.
13
Q A nd w ho was it that did the m ajority o f that
13
"Since that date w e have continuously
14 evaluation, o r m aybe all o f th at evaluation?
14 m onitored com posite sam ples for W indsor using
15
A M uch o f the evaluation at one point w as the
15 transm ission electron m icroscopy, the m ost sensitive
16 C olorado S chool o f M ines.
16 technique for fine asbestos fibers."
17
Q Did they also use a comm ercial testing group?
17
Q Cutting to sort o f the chase, as we say it -
18
A They did, indeed.
18
A Yeah.
19
Q W ho was that?
19
Q - w hat does M r Stewart say about their
20
A They used one o f the few that were available,
20 collection o f evaluations o f W indsor talc through the
21 and that w as M cC rone Associates.
21 15 years o f evaluating that talc, starting in Septem ber
22
Q I have m arked num ber 234.
22 o f 1971 and as o f the date o f the letter in M ay, 1987?
23
(Exhibit 234 m arked for identification)
23
A W ell, in the second paragraph he states:
24
I didn't go back through all o f the docum ents
24
"Throughout this entire period I can only
25 that M r Panatier show ed to you, although it m ay have
25 recall two occasions on w hich som e suspicious material
Page 1164
Page 1166
1 felt to you and the jury like I did, but there w ere a
1 w as detected. The first involved possible chrysotile
2 num ber o f testing results that he talked with you about
2 contam ination in an air sample and the contam ination
3 from M cCrone Laboratories.
3 source was subsequently pinpointed as a deteriorating
4
And rather than going back through all o f
4 clutch in som e m echanical equipment".
5 those, I have provided you with num ber 234.
5
Q A nd let m e stop you there.
6
W hat is this, sir?
6
Y ou were asked a num ber o f questions by
7
A This looks like a retrospective sum m ary o f
7 M r Panatier about M cCrone and its reporting.
8 events in the previous few years.
8
W hat does M cCrone itself comm unicate to this
9
Q And who is the letter from and w ho is the
9 outside third party about the status o f their testing
10 letter to?
10 fo r the sam ple that show ed som e chrysotile?
11
A It's from M cC rone A ssociates, it's dated 21
11
A It said that they believe they did find some
12 M ay, 1987, a n d it is to M r B en n in g er a t A rm strong W orld 12 chrysotile, an d it w as likely to n o t have com e from the
13 Industries Inc.
13 talc, b u t from a piece o f equ ip m en t in the facility.
14
Q Does it have a copy with anyone associated with
14
Q W hat does he say about the second occasion in
15 W indsor M inerals?
15 w h ic h th ey found suspicious m aterial in the talc?
16
A It has a copy o f -- to M r R oger M iller at
16
A "The second occasion was so novel that it was
17 W in d so r M inerals.
17 w ritten up in our publicity brochure published around
18
Q A nd rem ind us, w ho is M r M iller?
18 ... 75-76."
19
A He w as the --basically, he was the Plant
19
He encloses a copy.
20 D irector at the W indsor M inerals operation.
20
" S u ffic e ... to sa y th at am id st m utterings
21
Q In 1987, w hat does M r Stewart report to
21 ... [that] 'th at in spector is no lo n g er w ith us', the
22 M r Benninger, w ho I am assum ing was either another
22 Illinois EPA wrote to W indsor M inerals to the effect
23 custom er or a potential custom er that he w as looking to 23 that they w ere satisfied that W indsor's product is free
24 evaluate?
24 o f asbestos. That has always been our opinion and
25
A W ell, w e'll pull out the im portant parts.
25 concludes to be --continues to be our opinion based on
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1 o ver 15 years o f closely exam ining this product."
1
Q How long was that the process, or how long has
2
Q So, in addition to the inform ation that M cCrone
2 that been the process?
3 w as providing to Johnson & Johnson about the lack o f
3
A Essentially, ever since the Verm ont mine was
4 asbestos in the W indsor talc, w hat were they reporting
4 opened and shipping product.
5 to unaffiliated companies regarding that same matter?
5
Q H ow often were m aterial analysis reports
6
A They gave a sum m ary o f their results in the
6 generated?
7 previous 15 years th at stated they h ad not found
7
A Generally, every two weeks.
8 asbestos in the W indsor talc used by Johnson &
8
Q I'm going to show you w hat I've m arked as
9 Johnson's baby products.
9 num ber 235.
10
Q So any implications to the contrary would be
10
(Exhibit 235 m arked for identification)
11 inaccurate. W o u ld y o u th in k th at w o u ld be correct?
11
W hat is this?
12
A That is w hat is im plied in this letter, yes.
12
A It is a certificate, M aterial Analysis Report,
13
Q Okay.
13 w hich is a n analysis o f the product.
14
W e've talked about m ines. W e've talked about
14
It's the vendor Cyprus M inerals is describing
15 ore. W e've talk e d ab o u t the product. L et's talk a
15 W in d so r 66 talc, w h ich is the talc u sed in Johnson's
16 little bit m ore about finished talc testing.
16 baby products, and they describe their analysis, their
17
Y ou described something called "bulk
17 a ssay fo r various im p o rtan t factors, such as m oisture,
18 testing". W h a t does th at m ean?
18 a cid solubility, m agnesium , color, b u lk density, its
19
A Bulk testing is to evaluate the talc samples
19 degree o f fineness, am ounts for arsenic, heavy m etal,
20 b efo re th ey 're p ack ed into little h a lf p o und
20 water, w ater soluble iron, and assay for asbestos.
21 containers.
21
Q O n this particular one, w hat does it reflect
22
So it's the bulk m aterial before it's
22 about asbestos?
23 shipped, o r w hen it's shipped to the factory for
23
A In this particular one, the specification
24 filling into containers.
24 lim its are none detected, and none are detected.
25
Q Does the company get from the supplier any
25
Q It shows that the laboratory report was
Page 1168
Page 1170
1 confirm ation that the m aterial is in fact in compliance
1 reviewed by someone.
2 w ith the specification as it relates to this bulk
2
W ho w ould have reviewed this material?
3 sampling?
3
A It w ould have been review ed by the -- this is
4
A Yes, the com pany is required to receive from
4 actually signed by the Johnson & Johnson Products
5 the supplier a regular audit to demonstrate absence o f
5 Com pany in Royston, Georgia. So they've obviously
6 asbestos in the bulk sampling.
6 checked it, and before it w ould be shipped, it w ould be
7
M S FRO ST: Can we go off for just a second?
7 review ed by the laboratory in Vermont.
8 I'm m issing a document.
8
Q Does it have an indication for w hether -- what
9
(O ff the record at 1:17 pm)
9 to do w ith the product?
10
(O n the record at 1:18 pm )
10
A It says it's --the m aterial conform s to
11 B Y M S FR O ST :
11 specification and it's a ccep t or n o t accept, an d it's
12
Q For the bulk testing, did that relate to rail
12 ticked accept.
13 cars?
13
You can accept this product.
14
A Yes.
14
Q Rather than go through every single such
15
Q A nd w hy w ere you testing rail cars? W hat was
15 docum ent, have y o u seen docum ents like this for
16 th e relationship b etw een a rail car and talc?
16 shipm ents other than num ber 235?
17
A O kay. T alc is shipped from the m ine in V erm ont 17
A I've seen very, very m any, yes, yes.
18 g ro u n d a fte r being h e ld in silos in rail cars, a n d it's
18
Q All o f them generally the same sort -
19 sh ip p ed for filling in the facto ry in G eorgia.
19
A All o f them generally the same. All o f them
20
Q In connection with filling the rail cars, did
20 w ith a sum m ary which says the product conform s and it
21 the com pany receive any sort o f m aterial analysis
21 m ay be accepted, yes.
22 report from the supplier related to those rail cars?
22
Q W e do product testing, w e do rail car testing.
23
A Yes. It's a requirem ent to supply a statem ent
23 D id Johnson & Johnson also have any sort o f a process
24 ensuring the compliance to the specification for the
24 to do testing regarding asbestos in a more global
25 shipment.
25 sense?
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1
T hat apparently w as a very poor question.
1 of the talcs that it was using in baby powder and other
2
A It was.
2 cosmetic powders?
3
Q It's late in the day.
3 A It concluded that, on a global basis, there was
4
A Try again.
4 no asbestos contamination in any of the talcs used in
5
Q W e'll try that one again.
5 the Johnson's products around the world.
6
Did Johnson & Johnson have any other program
6 Q Let's summarize. We've talked about 1946
7 for the testing o f asbestos or m onitoring o f asbestos
7 through some period of time, and the company testing.
8 related to the talc?
8
What was the company's conclusion, based on
9
A Yes.
9 the testing that you are able to document going back
10
Q A nd w hat was that?
10 into the '40s and '50s?
11
A Certainly in the early 1970s, the decision was
11 A Going back into the '40s, '50s certainly into
12 tak en in the com p an y th at the q u ality standards that
12 the '60s, 70s, and then the worldwide monitoring
13 w ere applicable in the U n ited S tates should a p p ly to
13 program 75 onwards, right up to 2000 and beyond, many,
14 every country a ro u n d the w o rld w here consum ers w o u ld 14 many hundreds of talc samples were made, and in no case
15 b u y Johnson's B ab y P ow der o r Jo hnson's talc products. 15 was asbestos found in any of the talc samples.
16
A nd so to initiate that, a project was
16 Q Well, then let's turn to another subject.
17 u n d ertak en on p re tty w ell a n annual basis w hereby
17 Let's talk about some of the researchers who were
18 overseas affiliates from E urope, A frica, F a r E ast,
18 looking at talc in the early 1970s.
19 L atin A m erica, w o u ld send reg u lar - send a sam ple o f
19
You are familiar with a gentleman by the name
20 their finished product talc, as purchased from the
20 ofDrLewin?
21 local store, to N ew B runsw ick for evaluation for
21 A Yes,lam .
22 quality and purity.
22 Q Who was Dr Lewin?
23
Q I'm going to hand you w hat I've m arked as
23 A Dr Lewin was a researcher based in New York and
24 number 235.
24 he was commissioned by the Food and Drag Administration
25
M S KAGAN: 236.
25 to evaluate talc samples in the United States.
Page 1172
Page 1174
1
M R PANATIER: I thought the last one was 235.
1
Q Did D r Lew in ever work for Johnson & Johnson,
2
M S FRO ST: I'm going to hand you w hat I have
2 to your knowledge?
3 marked as num ber 236.
3
A H e did not.
4
(Exhibit 236 m arked for identification)
4
Q I'm going to hand you docum ent num ber 237.
5
Q W hat is that, sir?
5
(Exhibit 237 m arked for identification)
6
A This is a report entitled Johnson & Johnson
6
A nd this -- are you fam iliar with this
7 W orldwide 1975 Talc M onitoring Program.
7 document?
8
Q And is that the program that you were just
8
A I've seen this before, yes.
9 describing for us?
9
Q A nd w hat is this?
10
A It is, yes.
10
A This is a report dated A ugust 11,1972. It's a
11
Q W hat is the frequency with which this talc
11 m eetin g b etw een F o o d a n d D rug A dm inistration
12 p ro ject w as done?
12 representatives, o f w hich there are six nam ed, and
13
A For most o f about 25 years, it was done
13 co nsum ers -- or, sorry, com panies selling consum er
14 annually. I th in k th ere m ay have b een a couple o f
14 products to the industry. So from the industry,
15 y ears w h en it w as skipped fo r a year, b u t pretty w ell
15 in clu d in g Jo h n so n & Johnson, others, M cC rone
16 an nually ov er a p e rio d o f 25 years.
16 A ssociates, Gillette, W hittaker C lark & Daniels, A von
17
Q A nd w hat was the finding o f the annual report
17 P roducts, the M ennen C om pany, C heesebrough-P ond's, an 1
18 o v e r the course o f th at 25 y ears?
18 D r L ew in h im self w as there.
19
A O ver that tim e, and this is taking m any, m any
19
Q W hy was Johnson & Johnson and its industry
20 talc samples from all over the w orld, in no case did
20 colleagues m eeting with the FDA to talk about D r Lewin?
21 the com pany ever find asbestos in any o f the Baby
21
A W ell, D r Lewin, as I said, had been given the
22 Products Com pany products.
22 project to take a look at products on the US market
23
Q Having found no asbestos in those products over
23 for --to check whether or not there was asbestos
24 that period o f tim e, w hat conclusion did Johnson &
24 present.
25 Johnson reach regarding the asbestiform m ineral content 25
Q A nd how m any products do you understand that he
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1 tested?
1
A Yes. W hat D r N ashed stated was that Johnson &
2
A A lm ost two hundred. I think it was 192 or
2 Johnson:
3 thereabouts.
3
"... reported w ork they had done on a J& J
4
Q O f those, how m any products by Johnson &
4 product w hich D r Lew in reported as having chrysotile.
5 Johnson did he test?
5 D r N ashed reported that J& J scientists (Dr Stewart and
6
A A s I recollect, there w ere 11 th at h e'd tested.
6 M r Rolle supervised the analyses) had examined a
7
Q A nd in his initial testing, how m any o f those
7 portion o f the very same sam ple that Dr Lewin had
8 11 d id h e rep o rt th at he h ad fo u n d a percentage o f
8 analyzed and found no detectable chrysotile. They
9 asbestos?
9 reportedly used the follow ing techniques, petrographic
10
A H e thought he'd found asbestos in seven o f
10 analysis, electron m icroscopy, electron diffraction,
11 those, as I recollect.
11 p o w d er cam era x-ray, scanning x -ray and step scanning
12
Q Did Johnson & Johnson agree or disagree with
12 x -ray ... E ach sam ple w as analyzed fo r chrysotile and
13 h im on th at finding?
13 n o detectable am o u n t w as found".
14
A T hey totally disagreed for the sim ple reason
14
Q T he conclusion o f this m em o from the FD A is
15 th a t it d id n o t reflect the testin g th at Johnson &
15 reflected in the final paragraph.
16 Johnson had done and other laboratories had done over
16
Can you tell us w hat the conclusion o f the
17 th e p rev io u s few years.
17 m eeting w as, as reported by D r W enninger?
18
Q Because o f that, did --is that what
18
A It sim ply states:
19 p recip itated th e m eeting w ith the FD A ?
19
"There was no disagreement between FDA and
20
A Yes, yes, and it was concern not just in
20 industry scientists present at this m eeting about the
21 Jo h n so n & Johnson, b u t w ith o ther com panies th at D r
21 potential safety hazard that the presence o f asbestos
22 L ew in's results did not reflect reality.
22 in talc containing cosmetic products poses to the
23
Q W hen you say that, tell us about the m em orandum 23 consumer".
24 o f the m eeting with D r Lew in and the FDA.
24
Q Does the docum ent also indicate that D r Nashed
25
W hat does it say that D r Lew in reported in
25 represented to the FD A that analytical data w ould be
Page 1176
Page 1178
1 connection w ith his technique for having identified
1 m ade available?
2 w hat he thought was chrysotile?
2
A It does.
3
A Yeah. W ell, D r Lew in was using x-ray
3
Q A nd w hat does it say in that connection?
4 diffraction as a means o f detecting chrysotile and
4
A It said:
5 trem olite, w hich he described as tw o species o f
5
"D r N ashed said that J& J w ould m ake all
6 asbestos in the talc samples analyzed. He found other
6 analytical data on the analyses o f their talc samples
7 m aterial species that he thought did not interfere.
7 available to FD A on a non-confidential basis in the
8
So he was using a technique o f x-ray
8 very near future".
9 diffraction to try to identify chrysotile.
9
Q Now, D r Lew in him self had something to say
10
Q W as there a discussion at this m eeting about
10 about the accuracy o f his findings, did he not?
11 w h eth er electron m icrographs reflected talc in the -
11
A He did, yes.
12 reflected asbestos in the talc o f th e p ro ducts th at had
12
Q I'm going to hand you w hat I've m arked as
13 b een evaluated?
13 n u m b er 238.
14
A W ell, the discussion centered around the x-ray
14
(Exhibit 238 m arked for identification)
15 d iffraction pictu res o r results a n d it w as p o in te d out
15
A Yes.
16 to D r L ew in that x-ray diffraction w ould not
16
Q Have you seen this before?
17 n ecessarily d etect asbestos m aterial as a single test
17
A Yes, I have, yes.
18 m ethod.
18
Q A nd what is this?
19
Q Now, D r Nashed attended this particular m eeting
19
A W ell, this is a letter to The W all Street
20 on behalf o f Johnson & Johnson, did he not?
20 Journal from Professor Lew in at N ew York University and
21
A He did, yes.
21 he --it's headed A sbestos R eport. H e --D r L ew in
22
Q A nd w hat did he report to the FD A regarding the 22 states:
23 w ork that had been done on Johnson & Johnson products, 23
"I w ish to m ake a sm all correction t o ...
24 the ones that are the same that D r Lew in had reported
24 [the] generally accurate article that appeared on
25 as having contained chrysotile?
25 February 26, dealing w ith the FD A 's concern over the
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1 possible health hazard posed by the presence o f large
1
W hat does he conclude at the end o f the day
2 am ounts o f asbestos-type impurities in cosmetic
2 in his reporting about the evaluations he's m ade o f the
3 powders".
3 various cosm etic talc products?
4
Q W hat did he have to say specifically as it
4
A Yes. In point 7 he states:
5 related to his findings on Johnson & Johnson's pow der?
5
"M ost o f the com m ercial talcs tested are free
6
A "In the article referred to, I w as erroneously
6 o f any detectable am ount o f any o f the asbestiform
7 quoted as having reported that Johnson and Johnson's
7 minerals, according to the criteria enumerated above.
8 talcu m p o w d e r con tain ed 2 ... to 3% asbestos. In
8 Thus, there appears to be an adequate supply o f talc
9 actual feet, I rep o rte d th at o f 11 sam ples o f the
9 for w hich there is no ambiguity about the absence o f
10 products o f this com pany, I found no asbestos in nine
10 chrysotile or trem olite. In about 10% o f the sam ples
11 o f th e sam ples, a n d [in] the o th er tw o sam ples fell
11 ... there appear[s] to b e definitely detectable am ounts
12 in to the in co nclusive categ o ry described above. T hese
12 o f either chrysotile or trem olite present".
13 are -- resu lts are n o t seriously a t variance w ith those
13
Q H e has a key that indicates the products, and
14 reported b y investigators retained by the com pany."
14 i f you look, num bers 29 and 30 -
15
Q W hat was the expert disagreement as it related
15
A Thank you.
16 to D r L ew in's classification o f m inerals as having been
16
Q - - are Johnson & Johnson?
17 chrysotile, to the ex tent th at y o u know ?
17
A Yes.
18
A I think what cam e out o f the m eeting and the
18
Q And then if you go a few pages further on,
19 d ialogue a n d discussion afterw ards w a s th at D r L ew in
19 num bers 1 3 1 ,2 ,3 ,4 ,5 , 6 ,7 and 8 are also Johnson &
20 realized, as did m any other people after the m eeting,
20 Johnson products; correct?
21 th a t the m eth o d o f differential x -ray analysis w as n ot
21
A They are, yes.
22 specific to detect asbestos, and that you need to go on
22
Q And if you turn to the results in the back
23 and do further testing to confirm whether or not that
23 w here he has the listing o f his final report results,
24 result is the case.
24 w hat does it show for num bers 29 and 30, w hich are the
25
A nd in the case o f chrysotile, it is well
25 tw o Johnson & Johnson products first listed?
Page 1180
Page 1182
1 recognized that the x-ray analysis confuses chrysotile
1
A H e's listed chrysotile trem olite as
2 w ith a harm less m ineral called chlorite, w hich is
2 non-detected.
3 com m only found associated with talc.
3
Q For both o f those?
4
Q I th in k yo u 'v e m entioned chlorite before. W hat
4
A For 29 and 30.
5 is chlorite? Y ou said that it w as basically harmless?
5
Q T hen if w e turn over to the listings for the
6
A It is. It's a m agnesium silicate w ith a
6 rem aining products, num bers 131 through 138, w hat did
7 calcium atom on there. So it's very sim ilar to talc.
7 he ultim ately conclude?
8 It's totally innocuous, quite safe, but it's
8
A Right, I'm m issing those pages. They're out o f
9 occasionally found in association w ith talc.
9 order.
10
Q A nd w hat did you tell us earlier was the
10
Q Here, you can use this one.
11 chem ical d escrip tio n o f talc?
11
A O kay. I've g o t th em now . Y eah, okay.
12
A M agnesium silicate.
12
131 for trem olite, he describes as trace in
13
Q I'll hand you w hat I have m arked as num ber 239.
13 sam ple 131, b u t in 132 d ow n to 140, non-detected.
14
(Exhibit 239 m arked for identification)
14
A nd for chrysotile, he describes non-detected
15
This is, I believe, the final report o f D r
15 from 131 d ow n to 140.
16 L ew in.
16
Q So at the end o f the day, in connection with
17
Have you seen this?
17 the testing that D r L ew in d id in the early 1970s, w hat
18
A I think I've seen som ething sim ilar, yes.
18 w as the conclusion about the presence o f asbestos in
19
Q Okay.
19 the Johnson & Johnson product?
20
Let's take a look if you w ill turn to the
20
A The com pany's conclusion w as that there w as no
21 th ird pag e o f the docum ent. W hose is the signature?
21 asbestos in the product.
22
A SZ Lewin. Yes, Professor Lewin.
22
Q W hat about D r Lew in's conclusion?
23
Q In connection with the report that D r Lewin
23
A D r Lew in sim ply stopped at the point where he
24 m ade in July o f '73, let's look at the very last
24 noted trem olite in one sam ple, but he'd not defined
25 paragraph on page 3 in his Summary.
25 whether it w as asbestos trem olite or not asbestos
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1 tremolite.
1 D r L ew in didn't know w hat he w as doing.
2
Q Did D r Eierm ann at the FDA have any comm ents
2
His results were basically not valid.
3 regarding D r Lew in's findings?
3
Q In addition to D r Lewin, we talked about
4
A There w ere -- w ell, there w ere regular m eetings
4 som eone called D r Langer, or you spoke with M r Panatier
5 betw een consum er companies, including Johnson &
5 about a Dr Langer.
6 Johnson, and FD A, and D r Eierm ann certainly summarize 6
W ho was Dr Langer?
7 som e o f those meetings, yes.
7
A H e's a researcher at M t. Sinai in N ew York.
8
Q I will hand you num ber 240.
8
Q Okay, and what was his relationship to Johnson
9
(Exhibit 240 m arked for identification)
9 & Johnson?
10
W hat is num ber 240?
10
A I don't believe he'd ever w orked for Johnson &
11
A It's a letter from H einz Eierm ann, dated
11 Johnson. H e 'd done som e independent research o f his
12 O cto b er 1, 1973.
12 o w n on talc analyses.
13
Q A nd rem ind us, who is D r Eierm ann?
13
Q A nd in connection with the analysis that he
14
A A t that tim e in '73, he w as w ith the Food and
14 did, w hat w as the report o f w hat he found initially?
15 D ru g A dm inistration.
15
A Again, he claim ed w ith one o f his colleagues
16
Q A nd w hat does he report to us in connection
16 that --he claim ed to have found asbestos in Johnson &
17 w ith the Sum m ary and Com m ents on the A nalyses for
17 Johnson, and indeed in other products on the U S m arket.
18 A sbestos in C osm etic T alc P roducts?
18
Q A nd in connection with the w ork that he did, he
19
A W ell, it's a long m em o. W e'll ju st focus on a
19 d id tw o sets o f analyses, did he not?
20 couple o f sentences.
20
A He did, yes.
21
But it comm ents on the w ork by following
21
Q A ll right. H e did one in the early '70s?
22 investigators, o f w hich D r Lew in is one, and D r Schulze 22
A Yes. It w as '71,1 think.
23 from the FD A was there, and they summarize:
23
Q A nd then som e later testing in '76?
24
"T here is p o o r correlation betw een D r L ew in's
24
A H e published in '76, yes.
25 results and the findings o f the other investigators".
25
Q All right.
Page 1184
Page 1186
1
Q A nd in the next paragraph, w hat does he report
1
In connection w ith the 1971 testing, I have
2 as the reason for those discrepancies?
2 marked num ber 241.
3
A H e said:
3
(Exhibit 241 m arked for identification)
4
"The reason for these discrepancies m ay be
4
A fter the initial reports concerning D r
5 found in D r L ew in's ow n notes o f July 10,1973, in
5 Langer's findings, w hat did he later report concerning
6 w hich he stated: 'the chrysotile that I found in
6 w hat he had claimed to find in connection with baby
7 comm ercial talcs is generally different in significant
7 powder?
8 respects from the chrysotile that occurs as m assive,
8
A He claim ed to have found -- initially, he
9 fibrous g row ths in v e in s ... [of] serpentine rocks.
9 claim ed to have found asbestos in the baby powder.
10 T h at is, th e form er h as [a] d iffraction p e a k ... that
10
Q A nd w hat did he ultim ately report to the news
11 m a y differ from th e latter b y as m uch a s p o in t 0.2 A
11 m ed ia co n cerning w h at h e found?
12 ... It is th erefore - it is m ore reactive to w ard
12
A W ell, he just says:
13 d ilute acids; it show s a d ifferent appearance u n d er the
13
"Foolishly I sent them a w ritten report after
14 m icroscope; a n d [in] i t s ... [differential therm al
14 lo o k in g a t on ly tw o sam ples ... T he data w ere very
15 analysis] endotherm s and exotherm s are sh ifted relative 15 p relim inary in n a tu r e ... a n d ... I m ay have [ b e e n ] ...
16 to those o f the latter (and apparently dim inished)'.
16 m istaken [in looking at] long talcum fibers for
17 H e fu rth er states th a t 'the analytical m ethod (x-ray
17 asbestos fibers. T hey have [very] sim ilar properties".
18 d iffraction) g ives a rep ro ducibility o f plu s o r m inus
18
Q Is that the quote from D r Langer?
19 2 % to 3% average dev iatio n in replicate determ inations 19
A T hat is a letter. I guess he was trying to set
20 on the [very] sam e sam ple, but different sam ples from
20 the record straight. He w rote a letter to the - - 1
21 th e sam e b u lk co n tain er are fo u n d to vary a s m uch as
21 believe it w as T he N ew Y ork Tim es.
22 200% '".
22
Q A nd in connection w ith his --the report o f his
23
Q All right. In plain English, w hat is that
23 story, w hat did he ultim ately say about his analyses?
24 telling us, sir?
24
It's the next paragraph after the --
25
A W ell, it's telling m e that the FD A thought that
25
A It's very sm all font.
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1
Q Sorry about that.
1 1976, w hat was the takeaw ay conclusion o f Johnson &
2
A V ery sm all print.
2 Johnson from the w ork done by D r Langer in '76?
3
"... M t. Sinai lab has been actively involved
3
A T hat he'd found no asbestos in any o f the
4 in warning the public o f the dangers o f inhaling
4 Johnson & Johnson products.
5 asbestos f i b e r s ...
5
Q W as Johnson & Johnson able to obtain the
6
D r ... Selikoff, w ho heads the laboratory,
6 results o f the investigation from the FDA related to
7 has a -- has been a central figure in the controversy
7 those products?
8 o v er a s b e s to s ...
8
A I believe so, yes.
9
B ut L anger said [that] the am ount o f asbestos
9
Q I will hand you what I have marked as number
10 he saw in baby pow der w as only 'trace level'."
10 243.
11
Q W hat did he say about w hat he thought about the
11
(Exhibit 243 m arked for identification)
12 im portance o f looking fo r asbestos in talcu m pow ders?
12
Is this is a 1976 document from the FDA
13
A W hat he said was the data very prelim inary in
13 regarding the evaluation o f asbestos m inerals in field
14 nature, and:
14 activity surveillance?
15
"... w h at is m ore, I m ay have [been]
15
A Yes.
16 m istaken --m istaken long talcum fibers for asbestos
16
Q W hat does "field activity surveillance" mean?
17 fibers. T h ey hav e sim ilar properties".
17
A It's a project that FD A has from tim e to time.
18
He continued:
18 T hey'll go into stores and take sam ples o f m any
19
"It ann o y s the hell o u t o f m e -- t h e r e ...
19 different types o f products, lipstick, nail polish and
20 [is] a lot m ore im portant things than looking for
20 other products, and they look to ensure that they are
21 asbestos in talcum powder".
21 safe to the consum er.
22
Q All right.
22
Q And, again, what was the conclusion based on
23
But, nonetheless, he returned to the issue o f
23 that evaluation o f products and the Johnson & Johnson
24 looking for asbestos in talcum pow der in 1976, did he
24 products?
25 not?
25
A W ell, they looked at over -- alm ost 200
Page 1188
Page 1190
1
A He did, yes.
1 products, I think, yeah. They looked at alm ost 200
2
Q In 1976, w hat do you understand D r Langer to
2 products, including some Johnson & Johnson products,
3 have evaluated?
3 a n d the conclusion --give m e a s e c o n d ...
4
A He claim ed to have evaluated several products
4
Looking for trem olite fibers, w hich w ould be
5 on the US m arket and published a report as to w hat he
5 asbestos fiber, or chiysotile, which w ould be an
6 believed that they contained asbestos.
6 asbestos, they found none detected in Johnson's Baby
7
Q Once again, there w as an article in The New
7 Powder.
8 Y ork Tim es concerning his results, was there not?
8
Several sam ples o f Johnson's Baby Pow der,
9
A Correct, there was. 1976, yes.
9 they found none detected.
10
Q In 1976, w hen they reported th at ten o f 19 body
10
Q Okay.
11 a n d b ab y p o w ders h a d b e en found to contain asbestos
11
A nd is this is the Langer report or the Lewin
12 fibers - - 1 have handed you docum ent num ber 242.
12 report?
13
(Exhibit 242 m arked for identification)
13
A It's 176 sam ples. So let's have a look ...
14
A nd this is a copy o f (he article at The N ew
14
This is -- yes, this is a review o f D r
15 Y o rk tim es, w h a t w as his conclusion about the p ro ducts 15 L e w in 's d a ta . Y es.
16 in w hich he did n ot find asbestos?
16
Q Okay. Y ou m ay set that one aside.
17
A "The products that the researchers found
17
O ther than the w ork that was done with that,
18 u n co n tam in ated w ith asbestos fibers w ere A m m en's
18 the L anger m aterials received quite a bit o f coverage,
19 M ed icated P ow der, A von B ird o f P arad ise B eauty D ust, 19 d id th ey not?
20 D iaperene M edicated B ody Pow der; [and] tw o Johnson's 20
A They did, yes.
21 B aby Pow ders (... m ade here and one in Britain),
21
Q And, as with other issues with the FDA, the
22 Johnson's M edicated Pow der, M ennen B ath Talc, Y ardley 22 CTFA arranged for a m eeting w ith M t. Sinai, did they
23 After Shave Pow der and Yardley Original B ody Powder". 23 not?
24
Q Okay.
24
A They did, yes.
25
So o f the products evaluated by Mt. Sinai in
25
Q A nd did that include m em bers o f the staff o f
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1 Environm ental Science Laboratories, D r Langer and his
1
Q Is this 245?
2 cohort, D r Rohl?
2
A Yes.
3
A It did, yes.
3
(Exhibit 245 m arked for identification)
4
Q In connection with the m aterials that were
4
Q W hat is this, sir?
5 reviewed by D r Langer and D r Rohl, I have handed you
5
A The first page is a response from the Food and
6 number 244.
6 D rug A dm inistration and it is in response to a
7
(Exhibit 244 m arked for identification)
7 Citizen's Petition.
8
W hat is this?
8
Q A nd w hat is a Citizen's Petition, as you
9
A It's a m em orandum o f a m eeting, M arch 2 2,1976,
9 understand it?
10 a t M t. Sinai S chool o f M edicine, N e w Y ork, b etw een
10
A Putting it sim ply, it means that any citizen
11 m em b ers o f s ta ff o f the E nvironm ental Science
11 fro m the U n ited States can talk to F o o d and D rug
12 L aboratories a t M t. Sinai, D r L an g er a n d D r R ohl, an d
12 A dm inistration i f they have a concern or an issue on a
13 tw o peo p le fro m D ivision o f C osm etics T echnology o f
13 food, a drug o r a cosm etic, and they can require F D A to
14 FD A , M r W ilson and M r Yates.
14 com e to an opinion as to w hether that concern is valid
15
A nd they w ere discussing the topic o f
15 o r n o t valid.
16 A nalytical M ethodology fo r th e D etectio n an d
16
Q A nd w hat did the Citizen's Petition in 1983
17 D eterm ination o f A sbestos M inerals in Talc.
17 request o f the FD A in connection w ith cosm etic talc?
18
Q Right.
18
A W ell, the response to M r Douillet:
19
Now, in connection with this meeting, and I
19
"This responds to your Novem ber 8,1983,
20 apologize, I think I described it as a m eeting with
20 petition requesting that cosmetic talc be labeled with
21 F D A --this is actually a m eeting w ith M t. Sinai -- the
21 an asbestos w arning statem ent, inform ation on asbestos
22 ten products that D r Langer had done analyses on and
22 particle size and the proportion o f talc impurities in
23 reported the presence o f trem olite and anthophyllite,
23 the product".
24 those did not include a Johnson & Johnson product; is
24
Q W hat did the FD A conclude w as the appropriate
25 that correct?
25 thing to do in connection with the citizen request that
Page 1192
Page 1194
1
A They did not include a Johnson & Johnson
1 a warning be placed on cosmetic talc?
2 product.
2
A W ell, the response covers over --alm ost an
3
Q In fact, the docum ent itself lists the ten
3 inch o f documentation, but they basically summarized
4 products w hich he had evaluated.
4 having discussed how they had taken their approach, and
5
Can you tell us w hat those were?
5 w hat approach they had taken to com e to a decision.
6
A T hey w ere other products on the U S market.
6
A nd they sum m arized it by saying that:
7 Cashm ere Bouquet Body Powder; Rosem ary talc; Brut for 7
"However, your petition has not persuaded us
8 M en; A ir Spun Face Pow der from Coty; Baby talc from
8 that cosm etic talc that is presently being produced
9 B auer and Black; Black Label, Yardley; After Shave
9 contains sufficient am ount o f asbestiform m inerals --
10 Talc, English Leather; Z B T B aby Pow der; Invisible Talc 10 sorry, contains significant am ount o f asbestiform
11 fro m Y ardley; an d Shave talc from M ennen.
11 m inerals".
12
Q In addition to the Langer w ork and the FDA
12
Q W hat does it say about the FD A 's evaluation o f
13 analyses, d id -- w a s there ev er an y an alysis or
13 inform ation in the early 1970s, as th ey reported to the
14 interaction betw een the FD A and w hether o r not there
14 citizens?
15 w a s a hazard asso ciated w ith th e asbestos contam ination 15
A W ell, w hat they state is:
16 in cosm etic talc?
17
A Y es, I think it's fair to say that the industry
16
"In addition, FD A surveillance activities
17 that w ere conducted in the latter portion o f the 1970s
18 selling co sm etic talc w as k een to ensure th at the
18 show that the quality o f cosm etic talc had
19 p ro d u ct w as safe, a n d th ey w ere --there are reports o f
19 significantly im proved, and that even w hen asbestos w as
20 several m eetings betw een industry representatives and
20 present, the levels were so low that no health hazard
21 F ood and D rag A dm inistration, FDA.
21 existed".
22
Q In 19 --are you fam iliar w ith a 1983 Citizen's
22
Q U nderstanding w hat the FDA said about testing
23 Petition asking that a warning be placed on cosm etic
23 in the early 1970s, i f you look back on the first page,
24 talc?
24 the first paragraph explains w hat it w as that they did.
25
A Yes, I have seen that Citizen's Petition, yes.
25
A nd w hat does the FD A say that they did in
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1 connection w ith the evaluation o f the health status o f
1
Q In connection with the relevant data, did the
2 cosm etic talc?
2 FD A also look at the risk o f exposure in relationship
3
A W ell, they go on, and particularly in the last
3 to environm ental exposures?
4 paragraph, that they received several such reports and
4
A I'm sure they did. This is over an inch thick
5 they evaluated them by looking at the analytical
5 o f documentation. So give me a minute.
6 results and discussed how questionable they were:
6
Q Okay.
7
"... [The] assessm ent proved to be correct
7
H ere's an easier question: w hat do you
8 because m any questions were subsequently raised about
8 understand to have been their conclusion about the
9 results reported in the literature in the early 1970s
10
t
9 comparison o f a w orst case exposure to asbestos from 10 cosm etic talc as it relates to a lifetim e environm ental
11
And they give some references, and:
11 exposure?
12
"Because o f the questionable nature o f the
12
A A s I recollect, and I'm not going to read
13 analytical results, the agency w as n o t able to assess
13 several hundreds p ages o f docum entation, b ut as I
14 ... [the reliab ility of] the levels o f asbestiform
14 recollect, it w as o f no consequence.
15 m inerals in cosm etic talc t h e n ... [on] the
15
There's ju st no relationship. So it w as not
16 m arketplace."
16 o f significance.
17
Q Turning to the second page, what do they report
17
Q A t Johnson & Johnson --you can set that aside.
18 in the seco n d p arag rap h about the actions th at it took?
18
A Thank you.
19
A They stated that --took these actions:
19
Q Yes.
20
"... m an y cosm etic m an ufacturers b egan to
20
A t Johnson & Johnson, w ho all evaluated the
21 analyze their talc for asbestiform m inerals as part o f
21 published scientific literature concerning talc?
22 th eir q u ality control p r o g r a m s ... talc suppliers began
22
A It w ould say several people. Certainly, there
23 to sell higher purity talcs to the cosm etic industry.
23 w as a Research Departm ent, a M edical Department,
24 By 1976, asbestos analytical m ethodology was
24 several qualified M Ds, toxicologists.
25 sufficiently developed that the Cosm etic Toiletry and
25
Q W e talked about the Johnson & Johnson process
Page .1196
Page 1198
1 Fragrance Association (CTFA) could issue a
1 o f hiring outside experts to assist with talc issues.
2 specification (copy enclosed) for cosm etic talc. [The]
2
D id they use that sort o f outside expertise
3 ... specification required that such talc be free o f
3 for anything other than talc?
4 fibrous am phibole (e.g., asbestos in the form o f
4
A Yes. That's certainly not uncom m on in m any
5 asbestiform tremolite) using a CTFA m ethod o f analysis 5 corporations and com panies that you look at outside
6 that is capable o f detecting 0.5 per cent o f amphibole
6 help w here you think someone else has got a different
7 asbestos. This specification contributed to the
7 skill set. Yeah, certainly.
8 continued im provem ent o f cosm etic talc quality".
8
Clinical trials for one. You're not
9
Q Is the FD A referring in that discussion to the
9 necessarily going to do those in-house. Tests on
10 C T F A asbestos testin g standard th at w e talk ed about
10 product for skin irritation. T hose are all done
11 earlier?
11 outside.
12
A I believe they are, yes.
12
Q One o f the issues that you talked with
13
Q Does the FD A indicate that it has taken into
13 M r P an atier ab o u t yesterd ay h a d to do w ith publications
14 co nsideration th a t a n d o th er issues since the 1970s to
14 in the literature and Johnson & Johnson's involvem ent
15 evaluate th e safety o f such talc?
15 w ith its outside experts and others in connection w ith
16
A Yes. T hey indicate that they've certainly
16 that.
17 follow ed the issues a n d keep a n eye o n things.
17
D o you rem em ber those questions?
18
Q So w hat was their final conclusion?
18
A Yes, I do, yes.
19
A In their final conclusion, having review ed all
19
Q Right.
20 the data that they have found in the literature with
20
One o f the things that we talked about
21 spoken w ith experts, th ey sim ply conclude that:
21 yesterday had to do w ith C olorado School o f M ines'
22
"For all o f these reasons, your petition is
22 discussion o f a paper at the Bowling Green - from
23 denied. T his denial is w ithout prejudice to the future
23 Bowling Green University.
24 filing o f a petition on this m atter, accom panied b y all
24
Do you recall that?
25 relevant data in support o f the petition".
25
A I do, yes, yes.
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1
Q A nd docum ent num ber 188 was som ething that
1 m ay possibly m ake an identification o f anhydrite in
2 M r Panatier show ed you and talked w ith you about that
2 talc".
3 has to do w ith the Colorado School o f M ines' discussion
3
Q Y ou spoke yesterday w ith M r Panatier about the
4 w ith the Bow ling G reen people regarding their findings.
4 professional process o f m eeting with other scientists
5
Now, one o f the things that he show ed you in
5 to go through things that did not seem to be logical in
6 that docum ent had to do with the people w ho w ent to the 6 connection with a variety o f findings.
7 m eeting, but what he didn't talk to you about w as w hy
7
A s it relates to this document, mem orializing
8 it was that the Colorado School o f M ines had been asked 8 the m eeting between the Colorado School o f M ines and
9 to go and talk w ith their counterparts at Bowling Green
9 the Bowling Green research team, what does it reflect
10 to discuss the findings, as reflected in their article.
10 that w as discussed am ongst the scientists involved in
11
Can you look at the first page o f num ber 188
11 th at m eeting?
12 and read for us, please, w hat it is that it says there
12
A It summarizes w hat appears to be a very
13 regarding th e re aso n fo r th eir v isit to discuss these
13 technical discussion, and one o f the things about
14 issues with Bowling Green?
14 scientists, as I'm sure w ith law yers, is that there's
15 (E xhibit 188, prev io u sly m arked, han d ed to w itness)
15 general respect for each other, and you have an opinion
16
A W ell, this letter is from the Colorado School
16 as to w hat som eone has done, and if you find
17 o f M ines Research Institute, dated June 8,1973, and it
17 disagreem ent, you'll talk about it in a friendly and
18 describes the m eeting w ith Bow ling G reen University
18 positive m anner.
19 G eology Staff, and w hat is stated is that:
19
So that basically is the essence o f this
20
"Since our general observations at the
20 discussion.
21 R esearch Institute - that's Colorado School o f
21
Q A nd let's look at the specific item s that they
22 M ines -- relative to asbestiform m inerals in talc are
22 reflect, because M r Panatier talked with you about the
23 such --are at such high variance --sorry, such large
23 fact that there was a m eeting and it made clear that
24 variance to those reported in the paper, an
24 the data could be a serious charge against the product.
25 investigation o f the paper w as undertaken".
25
B ut let's talk about exactly w hat the authors
Page 1200
Page 1202
1
Q A nd how do you interpret that? W hat does that
1 and Colorado School o f M ines discussed in connection
2 mean?
2 with those findings.
3
A W hat it m eans is that Colorado School o f M ines
3
A Essentially, one o f the outcomes o f that
4 had been looking at talc samples from m any different
4 professional m eeting stated that:
5 suppliers, including Johnson & Johnson, and they had
5
"None o f the three authors had any previous
6 never found anything like the num bers that were found
6 experience w ith talc m ineralogy, b u t th ey d e c id e d ...
7 by the Bowling Green University group.
7 it w ould be a suitable subject for a paper. Our
8
Q Now , this docum ent goes on to talk about the
8 discussions yielded the follow ing significant results:
9 identification o f som ething called "anhydrite".
9
A ll three au th o rs re ad ily adm itted ... they
10
W hat is anhydrite?
10 did a 'rush job'. A bout 2 w eeks w as spent in gathering
11
A W ell, anhydrite is calcium sulphate.
11 d ata f o r ... [this] paper".
12
Q A nd w hat does the Colorado School o f M ines
12
Q W hat else does it show?
13 rep o rt in th is docum ent co n cerning the significance o f
13
A It says that:
14 the B ow ling G reen team 's finding o f anhydrite in
14
"They agreed that asbestiform minerals cannot
15 co n n ectio n w ith the m aterials th at it evaluated?
15 be identified by X -ray diffraction. X -ray diffraction
16
A W ell, calcium sulphate or anhydrite is a very
16 is capable only o f identification o f a m ineral group
17 sim ple m aterial, and w hat they say is that:
17 w hich contains both asbestiform and non-asbestiform
18
"T he m ineral [calcium sulphate] a n h y d rite ...
18 minerals".
19 i s ... reported b y X -ray diffraction for all except
19
Q W hat else did the Bowling G reen researchers
20 three o f the sam ples. W e have never found anhydrite in 20 agree w ith the Colorado School o f M ines about in
21 any talc sam ples exam ined at the R esearch Institute.
21 connection w ith the evaluation o f the quality o f
22 Furtherm ore, from the standpoint o f geological
22 research done to support their paper?
23 occurrence and ro ck g e n e s is ,... [we] w o u ld n o t expect
23
A "They admitted that they did not adequately
24 to find anhydrite associated w ith talc. W ith these
24 c h eck the 'talc edge effect' w hich could lead t o ...
25 factors in m ind, a study was m ade to determ ine how one 25 m isidentification o f talc plate edges as [an]
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1 asbestiform m ineral by m icroscopic analysis."
1 read to the jury those portions that M r Panatier did
2
Q N ow , th at's n o t som ething M r Pan atier talked
2 not ask you about and tell us w hat is your
3 w ith you about; correct?
3 understanding o f w hat w as being asked to be
4
A N o. I m ean, basically w hat they're saying is
4 accom plished in connection with the review o f Dr
5 if you have the plate set on its edge, it w ould look
5 H enderson's work?
6 long and thin, b ut they didn't separate that out.
6
A Sure. Just as a follow up, it was mentioned
7
Q And does the document reflect that there were
7 that M r Henderson was looking at electron m icroscopy
8 several other areas o f scientific discussion concerning
8 w here the particle is shadowed with platinum deposited
9 the quality o f the research?
9 under vacuum , and the final sentence is important:
10
A Yes. They agreed that they had m ade several
10
"M r Henderson claims that this pattern was
11 errors. T h ey agreed:
11 specific to talc an d anthophyllite only".
12
"They did not take into account the possible
12
T hen it goes on to state that:
13 p resence o f chlorite in the talc an d co uld w ell have
13
"Our inform ation was that these types o f
14 m isidentified chlorite as serpentine (w hich [would] o f
14 patterns w ere a function o f any cleavable m aterial".
15 course in c lu d e ... chrysotile)".
15
Q A nd w hat w as the significance o f the finding
16
T hey also adm itted that:
16 th at the patterns w ere the sam e as on any cleavable
17
"Relative to the identification o f anhydrite,
17 m aterial?
18 th ey a d m itte d ... th ey p ro b a b ly m isidentified ... [the]
18
A W ell, w hat it m eant w as that any cleavable
19 k -b eta talc peak" th at's o n the m achinery.
19 m aterial w ould not necessarily include anthophyllite or
20
And, secondly:
20 talc, so that the claim that M r Henderson m ade that the
21
"They counted only 100 grains for their
21 pattern w as specific to talc and anthophyllite w ould
22 quantitative m icroscopic analyses. Though their data
22 not be valid.
23 is p resen ted in term s o f v o lu m e ... W e p o in ted o u t ...
23
Q Is that an appropriate or an inappropriate view
24 the statistics involved are totally unacceptable".
24 o f how to deal w ith a scientific disagreement?
25
Q Does that indicate to you that the discussion
25
A I think the sum m ary here is that people are
Page 1204
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1 betw een the Colorado School o f M ines and the Bowling
1 setting out their position and m aking clear that, in
2 Green researchers was, as implied by M r Panatier, some
2 this case M r Henderson, w asn't accurate in his
3 sort o f a threatening meeting, or w ould you
3 interpretation.
4 characterize it in some other way, and if so how?
4
It's a professional dialogue.
5
A No, I think, as I've said earlier, that
5
Q You can set that aside, I believe.
6 generally when scientists sit dow n and talk to each
6
W as Johnson & Johnson involved in any w ay in
7 other, there m ay be an occasion for disagreement, but
7 subm itting materials to the NTP?
8 the outcome o f this m eeting is that the Bowling Green
8
A Forevaluation? For --
9 scientists realized that they had not understood the
9
Q For talc safety?
10 jo b pro p erly a n d h a d n o t g iv en accurate readings and
10
A For talc safety studies?
11 results.
11
I believe N TP did use talc in a talc safety
12
Q All right. Y ou m ay set that aside.
12 study, yes.
13
M r Panatier, also talked with you
13
Q A nd w e haven't talked about NTP. W hat is NTP?
14 d o cu m entation n u m b er 189, w hich is a C onfidential
14
A Okay. It's the N ational Toxicology Program o f
15 T alc - U K W o rk S tatus R eport.
15 the U n ited S tates. It's a div isio n o f the U S
16 (Exhibit 189, previously m arked, handed to w itness)
16 governm ent, w ho has a responsibility to evaluate the
17
A nd the area that I specifically w ant to talk
17 toxicology or safety o f m any different kinds o f
18 w ith y o u ab o u t is the d iscussion ab o u t th e evaluation
18 m aterials that are u sed both in industry --m ostly in
19 o f D r H enderson's w o rk reg ard in g cleavage fragm ents an d 19 industry - a n d also ju s t in the environm ent an d arou n d
20 patterns on cleavagable m aterial.
2 0 US.
21
N ow , as I understood the questioning from
21
Q Okay.
22 M r Panatier, it w as his im pression, at least, that the
22
D id you personally have any involvem ent in
23 com pany was discrediting D r Henderson generally.
23 subm itting m aterials related to talc to the N TP for an
24
Can you review the parts o f that docum ent
24 evaluation at any point?
25 related to the evaluation o f D r H enderson's w ork and
25
A I personally did not, no.
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1
Q Did Johnson & Johnson subm it m aterials to the
1 m arket, they did extensive studies and show ed that in
2 N TP for its evaluation o f whether to list talc as a
2 no case were there asbestos m aterials present in the
3 carcinogen or a product reasonably expected to be a
3 product.
4 carcinogen?
4
Q In connection w ith the C itizen's Petition, w hat
5
A Are you talking about documentation?
5 did the FDA conclude concerning the need for a warning
6
Q Yes, sir?
6 on cosmetic talc products?
7
A N ot talc samples?
7
A W ell, they review ed all the literature that was
8
I believe Johnson & Johnson was certainly
8 technically available in --up to 1986 and beyond, and
9 involved in assem bling data to support the safety o f
9 they concluded that there was no reason to list a
10 talc for th at p articu lar review .
10 w arning on talc products.
11
Q W hat did the N TP conclude in connection with
11
Q Do you know whether they have revisited that
12 w h e th er o r n o t to list talc as a carcinogen o r a
12 question since 1986?
13 p ro d u ct reaso n ab ly ex p ected to b e a carcinogen?
13
A I believe they have, but I don't have that
14
A They concluded that there was insufficient data
14 docum entation w ith me.
15 to list talc a s a carcinogen.
15
I believe there has been a more recent
16
Q Do you have any idea o f w hat the constituency
16 C itizen's Petition, b u t I can't be sure, so I'm not
17 w as o f the g roup o f people w h o w ere m aking that
17 going to com m ent.
18 d ecision?
18
M S FROST: Okay. Let's take a five m inute
19
A W ithin the N TP process, the ROC process, the
19 break, please.
20 first level is undertaken to nom inate a product. It
20
(O ff the record at 2:19 pm )
21 co m es fro m w h a t are called the "staffers".
21
(O n the record at 2:33 pm )
22
They are relatively junior people in the
22 BY MS FROST:
23 organization who w ill pull together a proposal; and at
23
Q D r Hopkins, w hy is it that the FD A was involved
24 the second review it goes to a higher authority body
24 w ith the evaluation o f the safety o f cosmetic talc
25 w ith m ore --m ore skill set.
25 products?
Page 1208
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1
But in betw een tim es, people m ay m ake a
1
A W ell, FD A 's role to the A m erican consum er is to
2 subm ission and provide data inform ation that m aybe NTP 2 ensure that the products that are on the market are
3 didn't have at their first evaluation.
3 safe.
4
Q So is this a fairly thoroughly scientific
4
FD A has responsibility for - overall
5 review?
5 responsibility for cosm etic products.
6
A It's a very thorough review.
6
Q Could the FD A require a warning on cosmetic
7
It allows not just industry but consum er
7 products if it so wished?
8 groups to present data to N TP as part o f their review.
8
A If they had valid reason to do so, they could
9
Q And, again, at the end o f this review, w hat was
9 require that warning, yes.
10 the conclusion o f N T P regarding w hether or not to list
10
Q To date, have they done so?
11 talc as a carcin o g en o r a p ro d u ct reasonably expected
11
A They have not, no.
12 to b e a carcinogen?
12
Q Now, w e spoke previously about the NTP.
13
A N TP concluded that there w as no valid evidence
13
In advance o f the N TP's m eetings in 2000, was
14 to list talc as a carcinogen.
14 Johnson & Johnson aw are that they w ere going to be
15
Q In discussion o f -- actually, let m e m ove back
15 review ing talc as a potential carcinogen?
16 to the board for a m om ent. L et's m ake sure that we
16
A I'm not aw are that that w as part o f the story.
17 h a v e ...
17
There was no early warning other than the
18
So N TP concluded that talc was not a
18 N T P 's review , o r p ro p o sed rev iew in 2000.
19 carcinogen?
19
Q Okay.
20
A That's --
20
Did you, as part o f the work that you did
21
Q O r not to be listed?
21 w hile you w ere still at Johnson & Johnson, participate
22
A N ot to be listed as a carcinogen, yes.
22 in any specific FD A workshop or other evaluation
23
Q W hat w as the outcom e o f the FD A 's analysis in
23 regarding talc?
24 2009 and 2010 as it relates to cosm etic talc products?
24
A Yes. The FD A called a workshop in 1994 in
25
A B ased on their review o f products on the US
25 W ashington and I was a participant in that workshop.
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1
Q And w hat did the workshop consider?
1
D o you think that's a fair takeaw ay from the
2
A The w orkshop w as over two days. It considered
2 questions yesterday?
3 tw o m ain topics. One w as the results o f the rat and
3
A That is an interpretation, yes.
4 m ouse studies that N TP had conducted to evaluate talc
4
Q Okay.
5 safety by inhalation in rats and m ice over a lifetime.
5
N ow , one o f the documents that you were shown
6
Q Let m e stop you there. W e haven't talked about
6 yesterday, and I w ant to go through a series o f these,
7 that. W hat sort o f rat and m ouse study did they do?
7 and there's one for w hich I don't have a num ber. I
8
A Essentially, standard toxicology stuff.
8 didn't write the num ber down. It's O ctober 10,1974,
9
Y ou dose rats and m ice at different dose
9 M r A shton to D r Hildick-Smith.
10 levels o f talc dust, b reathable talc dust, an d they
10
M R PA N A TIER: H ere it is. 78. N o, that is
11 b reath e it in ev ery day o f th eir lives for tw o years.
11 another.
12
Q A nd w hat did those two years demonstrate in
12
W e'll figure it out.
13 co nnection w ith the ra t study?
13
MS FROST: Okay.
14
A The total sum m ary o f the study that was
14
M R PANATIER: It was an exhibit; right?
15 p resen ted b y the N ational T o x ico lo g y Pro g ram in 1994, 15
M S FROST: It is an exhibit.
16 b o th the ra ts an d the m ice, w a s th at th e talc w as n ot
16
So I'm going to ask about it and we'll come
17 resp o n sib le fo r a n y c an c er cau sin g effects.
17 back w ith the exhibit num ber.
18
Q Specifically, did the rat and m ouse study
18
Q In connection w ith the discussions for the
19 d isclose a n y m esotheliom a in the te s t subjects?
19 study that D r R ubino w as doing, there w ere a series o f
20
A They did not see any m esotheliom a in rats or
20 docum ents, and I'm going to try to do them in
21 m ice.
21 chronological order.
22
Q T hat is 1994?
22
Let's look first at docum ent num ber 192,
23
A It was reported in 1994, yes.
23 w hich is a m em o from D r G avin Hildick-Sm ith to D r
24
Q W e've been talking about an aw ful lot o f
24 Petterson talking about the initial m eeting to discuss
25 documents today. You personally attended this
25 the scope o f the study.
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Page 1214
1 particular seminar, but o f the documents we have been
1 (Exhibit 192, previously marked, handed to witness)
2 talking about this afternoon, had you reviewed and have
2
D o you rem em ber that?
3 fam iliarity w ith those documents prior to your arrival
3
A I rem em ber that, yes.
4 here today?
4
Q M r Panatier asked you some questions, but he
5
A Yes, indeed. M any tim es over m any years.
5 didn't ask you som e questions about the discussion on
6
Q How is that?
6 page 2 o f that m emo that describes w hat the m eeting was
7
A W ell, as an employee o f Johnson & Johnson from
7 about.
8 '76 and then through as a consultant to 2 0 1 1 ,1 had
8
Can you look for me, please, at the first
9 occasion to be involved in safety o f talc, and part o f
9 paragraph there on page 2 o f this docum ent and let's
10 th at w as to review those docum ents as and w hen the need 10 talk about w hat the docum ent reports as the purpose o f
11 arose.
11 th e m eeting?
12
So I have certainly seen them and I reviewed
12
A W ell, this docum ent is dated Decem ber 12,1973:
13 th em ov er th e --rereview ed th em o v e r the p a st several
13
"A m eeting was held with Professor Rubino and
14 weeks.
14 his associate, D r G Piolato, and it w as pointed out
15
Q A nd speaking o f rereviewing, we just talked
15 th a t the objective o f the epidem iological study w as to
16 ab o u t the ra t an d m ouse study, b u t som e o f the issues
16 determ ine w hether the incidence o f cancer in the
17 th at you discussed yesterday w ith M r Panatier had to do 17 diseased m iners w as different from that expected in the
18 w ith outside research th at w a s b ein g con d u cted b y D r
18 ... n o n-m ining po p u latio n in ... [the] adjacent area".
19 R u b in o in Italy.
19
Q Let me stop you there.
20
Do you recall that discussion?
20
W hose objective does the docum ent seem to
21
A Yes, I do, yeah.
21 reflect that refers to?
22
Q Okay.
22
A W ell, Professor Rubino and the people --the
23
The im plication w as that there was something
23 epidem iology experts in Italy.
24 untow ard about the actions o f Johnson & Johnson in
24
They are keen to understand whether or not
25 connection w ith that study.
25 there was an issue w ith incidence o f cancer.
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1
Q Right.
1 Tenovus group w ill be subm itting data on the content of
2
It goes on in the next paragraph. W hat else
2 talc in cancerous and norm al tissues".
3 does it say about w hat D r Rubino's objective w as with
3
Q W hat is the significance o f the description o f
4 the study, as explained in this first m eeting?
4 D r Rubino and his m ethodology in your review o f this
5
A W ell:
5 document?
6
"Prof Rubino w ill initially obtain the
6
A It sum m arizes that G avin Hildick-Smith, MD,
7 records --[all] the records o f all m ining em ployees
7 believed that he was working to the highest standards,
8 from 1945 to 1973 and determ ine those w ho have died and 8 using experts in statistics, biometrics, and getting
9 the cause o f death. In addition, som e o f the data will
9 together unassailable facts -- to quote those words.
10 be obtained from a m atched group o f non-m iners in an
10
Q Is that a good thing or a bad thing?
11 ad jacent com m unity. A ll the d a t a ... w ill be recorded
11
A T hat is a good thing. T hat w ould be called
12 on a standard form to allow it to be computerized".
12 good science.
13
Q Now , M r Panatier talked w ith you about the
13
Q Y ou m ay set that aside.
14 th ird p arag rap h and the fact th at it w o u ld involve
14 (E xhibit 197, previously m arked, handed to w itness)
15 review o f epidem iological experts and procurem ent o f
15
He also showed you this document from
16 optim um data.
16 O ctober 3 0 ,1 9 7 4 , another -- this one to D r
17
Based on your understanding o f the
17 H ildick-Sm ith from M r A shton, also concerning the
18 m ethodology involved in a study o f this nature, how do
18 Italian talc studies and a visit w ith D r Rubino.
19 you interpret that description?
19
Now, w hat M r Panatier asked you about was the
20
A W ell, the tw o paragraphs I've ju st read
20 instructions concerning the term s o f the talk, but what
21 indicate that the --Professor Rubino and the
21 he didn't ask you about w as the follow ing paragraph.
22 epidem iology contacts in Italy have pretty well decided 22
Can you read for us from the following
23 w hat appears to be a good protocol to review the data.
23 paragraph and explain to us the significance o f that
24
So they have already set up a nice protocol.
24 from your analysis?
25
Q You m ay set that aside, sir.
25
A Yeah. It discusses that Rubino read his talk
Page 1216
Page 1218
1
N ext docum ent I w ant to talk with you about
1 from the Italian draft and the English translation was
2 is also related to the epidem iological study o f the
2 translated by Stefano and Stefano.
3 cause o f death in Italian talc m iners. This one is
3
"There are some phrases which do not
4 m arked as Exhibit 193.
4 translate into English, but I gather they do not alter
5 (Exhibit 193, previously marked, handed to witness)
5 the findings o r the conclusions. Since O ctober 7 talk,
6
D ated February 14,1974. If you will take a
6 Rubino has an additional 200 case histories, but the
7 look at it and orient yourself.
7 results are the sam e as you have reported earlier."
8
Y ou spoke w ith M r Panatier about part o f this
8
Q So he has continued to compile data; is that a
9 yesterday, but I w ould like for you to look at the
9 fair understanding?
10 portion he didn't show you or ask you about on page 2
10
A T hat is the case, yes, and the period between
11 co n cerning the evaluation o f D r R ubino a s a researcher? 11 his talk an d w h e n th is m em o is w ritten, he h as g ot m ore
12
A O kay. T his docum ent is dated February 14,
12 data from m ore m iners.
13 1974, receiv ed in Jo h n so n & Jo h n so n M arch 12, '74, and 13
Q And if you turn to the second page, an
14 that particular sum m ary from D r Hildick-Sm ith, MD,
14 analysis, or in conjunction w ith the discussion by
15 w ritin g to h is colleagues in Joh n so n & Johnson says,
15 M r A shton o f the com m ents that he provided, w hat does
16 final paragraph:
16 he say w as the nature o f the com m ents th at he m ade to
17
"The im pression w as obtained from Professor
17 the draft o f the paper, as presented in this m eeting?
18 R ubino that he is a m eticulous w orker concerned with
18
A His first sentence says:
19 obtaining unassailable facts and [he] is h im self not
19
"I have some m ineralogical comm ents w hich I
20 concerned with personal gain from the study. Professor 20 told to Stefano".
21 Rubino is consulting with experts in the field o f
21
A nd then, as we discussed yesterday:
22 statistics and biom etrics and expects to have his study
22
"The first page o f the article has to be
23 com pleted so that he can have data available for the
23 carefully revised. The m ention o f two genetic sources
24 fall, 1974, m eeting ... h eld by D r S elikoff a t the N ew
24 o f talc and the phrase indicates that talc o f dolomite
25 Y ork Academ y o f Science at w hich M r Henderson o f the 25 origin has fibrous m ineral m ust be deleted. It is
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1 important that Rubino refers only to high grade
1 the m ineralogical m aterials in the rock ore and the
2 cosm etic talc to avoid paragenetic m aterial matters."
2 talc ore.
3
So he's com m enting on m ineralogical aspects
3
Q If you turn to the last page o f that document,
4 to D r Rubino.
4 and specifically to the section where their comments on
5
Q He goes on to m ake comm ents concerning som e o f 5 capabilities o f Rubino and staff - in sort o f sum m ary
6 the surprising findings about D r Rubino's evaluation.
6 fashion, w hat did M r Ashton report o f his evaluation of
7
W hat does D r --does M r A shton refer to in
7 the capabilities o f D r Rubino and his staff?
8 connection in this next paragraph about the findings
8
A W ell, in sum m ary, he looks -- he sounds to be
9 that were unexpected as it related to the evaluation o f
9 very im pressed by Rubino:
10 th e m iners a n d m illers?
10
"Rubino's m edical capabilities are w ithout
11
A Talking about the m ineralogical aspects o f
11 question. A s yo u w ell k n o w he is in d em and for talks
12 R ubino's talc article, he says:
12 o n the co n tin en t an d a recognized authority in
13
"You recall that a few o f us here were
13 o ccupational disease investigations".
14 talk in g ab o u t the surprising d ata w hich seem s to show
14
He goes on to say that he was pleased to
15 th at silicosis a n d pneum oconiosis w as h ig h er in the
15 lea m th at he has three electron m icroscopies at his
16 m in ers th an in the m illers. It w as surprising because
16 d isposal in th e hospital.
17 m illers are exposed to m ore d u st th an m iners. It w as
17
Q W hat is the significance o f three electron
18 very significant an d a testim o n y o f R ubino's veracity
18 m icroscopies b ein g available to D r R ubino during this
19 th at he's b een w o rrying ab o u t th at un expected
19 tim e p e rio d o f tim e?
20 relationship in his findings."
20
A W ell, at that tim e it was pretty amazing,
21
Q Is it good or a bad thing that D r Rubino is
21 becau se those are expensive, sophisticated pieces o f
22 reporting on an unexpected finding related to the
22 equipm ent. W hat it show s is that he has the best
23 m iners and m illers?
23 equipm ent available to do his research.
24
A That's good science. Y ou should report on w hat
24
Q A nd in the final paragraph that M r Panatier
25 y o u find.
25 didn't ask you about, w hat does M r Ashton say to his
Page 1220
Page 1222
1
Q Now, in connection with the next paragraph, you
1 colleagues concerning the qualities and independence o f
2 w ere asked som e questions about silica and the
2 D r Rubino?
3 drilling, but in the middle o f that paragraph there was
3
A H e states:
4 som e explanatory m aterial w hich seems to give context, 4
"M y opinion on Rubino is this. H e is a
5 but was not show n to you or asked about.
5 sincere, distinguished and m ost capable m edical
6
Can you take a look at that and tell us what
6 scientist. H e has at his disposal the m ost
7 is the im plication or im port o f that additional
7 sophisticated o f equipm ent and can go at any dust
8 information?
8 problem with profundity. Anybody w ho for a moment
9
A W ell, it says that:
9 thinks that Rubino, his data, or the hospital at the
10
"....the miners are exposed to host rock
10 U n iv ersity o f T u rin is anything b u t top flight has
11 d u st w h ich contains ... am ounts o f m uscovite ( m ic a ) ...
11 eith er snapped o ut [ o f it] o r is full o f crap".
12 quarts ( s ilic a ) ..."
12
Q Y ou can put that one in the stack.
13
How ever, it goes on to say:
13
N ow , let's look at docum ent num ber 207.
14
"The m illers never are exposed to those rock
14 (E xhibit 207, prev io u sly m arked, handed to w itness)
15 d usts o r to ... [the] m ineral b alance since m illers
15
D o you rem em ber 207 from yesterday? That's
16 o n ly m ill talc, n o t h o st rocks. R u b in o n o w needs a
16 the allegedly altered versio n --
17 w ritten reference [to] com m unication o n the m ineral
17
A The shortened version.
18 m ake-up o f the h o st rocks and talc ore. T he geological
18
Q - o f the prelim inary data?
19 rep o rt fro m C a rd iff (on file a t F D A here) is a useable
19
A Y es,Id o ,y es.
20 reference for that and I gave you the appropriate pages
20
Q I'm also going to show you the prepublication
21 y esterd ay fo r transm ittal to R ubino".
21 co p y o f the article p repared b y D r R ubino an d w hich you
22
Q Does that indicate that the m aterials being
22 discussed in som e detail w ith M r Panatier.
23 provided w ere to hide inform ation o r to provide 24 information?
23
A nd I w ant you to look at the prepublication
24 docum ent, num ber 207, and then w e're going to compare
25
A No, the intent was to provide inform ation on
25 that to num ber 202, and I w ant you to tell us w hat
42 (Pages 1219 - 1222)
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1 these three documents are and how they relate to each
1
Q A nd am ongst the sim ple tabulation in the
2 other?
2 published version, in w hich journal did you say that
3
A Yeah.
3 is?
4
W ell, in the prepublication department, as
4
A It's the Journal o f O ccupational M edicine.
5 this m atter was raised yesterday, there was a separate
5
Q In the Journal o f --
6 line item for cause o f death from larynx, lung,
6
A Sorry, Journal o f Occupational M edicine, yes.
7 trachea, oesophagus and stomach cancer.
7
Q Journal o f Occupational Medicine.
8
Q A nd in the prepublication -- that's the
8
And as an aside, who does the Journal of
9 prepublication?
9 O ccupational M edicine go to?
10
A That's the prepublication. There w as a
10
A W ell, generally, anyone w ho's interested in
11 relativ ely long list o f differen t types o f cancer.
11 h ygiene in industry. So it's p retty w ell anyone in
12
Q Okay.
12 industry: m ining, m illing, factories.
13
Now, when you turn to document number 207,
13
It relates to the health o f employees in any
14 w h ich is th e docu m en t th at M r P anatier a sk ed y o u about, 14 industrial application.
15 can yo u tell u s from looking a t nu m b er 207 w h at is the
15
M R PANATIER: Can you just show m e the front
16 sou rce o f th at docum ent?
16 page?
17
W here was it published?
17
Perfect. Thank you.
18
A I've n o t com e across th is a s b eing p u b lish ed in
18 B Y M S FR O ST :
19 a n y p eer rev iew m edical jou rn al.
19
Q In the chart on page 4 o f Exhibit num ber 204,
20
It doesn't have a page num ber on or a journal
20 w hich is the - or 202, the publication version --
21 reference, w hich you w ould norm ally find.
21
A Yes.
22
Q B y com parison, let's take a look at num ber 202.
22
Q W hat does it show as the incidence o f cancer
23 (Exhibit 202, previously m arked, handed to witness)
23 for the m iners and millers?
24
W hat is the publication inform ation as it
24
A It breaks dow n the incidence o f cancer into all
25 relates to the Rubino study for num ber 202?
25 m alignant neoplasm s, and then it goes on to look at
Page 1224
Page 1226
1
A W ell, this is a print from the Journal o f
1 neoplasm s --that's cancers --o f the larynx, and then
2 Occupational M edicine from M arch, 1974.
2 the lung, bronchus and trachea, and then it considers
3
Q And is the Journal o f Occupational M edicine the
3 the pleura, mesotheliom a, the oesophagus, the stomach,
4 sam e journal w hich was referred to yesterday in the
4 the intestine and the liver and any other sites.
5 documents as the one where one o f the in-house folks at
5
Q H ow does that com pare to the table that is
6 Johnson & Johnson was assisting D r Rubino in making
6 reflected in the prepublication document?
7 sure that the article w ould com ply w ith the
7
A L et's have a look.
8 requirements for publication?
8
W ell, the prepublication docum ent also
9
A Yes. It was, yes.
9 reviews all m alignant neoplasm s, lung, bronchus,
10
They have a house style that you follow that
10 trachea, larynx, oesophagus, stom ach, pneum oconiosis.
11 fo rm at i f y o u 're subm itting an article.
11
Y es, it's pretty well the sam e. V ery
12
Q N ow , M r Panatier asked you som e questions about 12 sim ilar.
13 th e very last pag e o f th at particu lar docum ent, b u t
13
Q Does D r Rubino m ake available data from which
14 w hat he didn't ask you about w as the chart regarding
14 one can analyze the incidence o f m alignancies am ongst
15 th e results o f findings am ongst the m iners a n d m illers
15 the m iners and m illers in his study?
16 in the talc a rea o f V al C hisone.
16
A Yes, it's published in this docum ent. He deals
17
If you will turn to the --is it the fourth
17 w ith both m iners and w ith both m illers and he looks at
18 p age?
18 actual em ployees a n d the control g roup o f non-em ployees
19
A Yeah. Yes.
19 and he com pares the two.
20
Q W hat do you fm d on the fourth page o f the
20
Q Y ou m entioned m esotheliom a. W hat does the
21 publication version o f the R ubino study?
21 study reflect as m esotheliom a findings in the m iners
22
A There's a sim ple sum m ary o f observed versus
22 and millers in Val Chisone?
23 expected deaths in both m iners and millers.
23
A He found that there w as no evidence o f
24
(Reporter clarification)
24 m esotheliom a in either the m iners or the m illers in
25
It's a sim ple tabulation.
25 their particular m ining operation.
43 (Pages 1223 - 1226)
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1
Q So if Johnson & Johnson w as attem pting to edit
1
A W ell, by 2003, they had a larger --what they
2 out o f the m edical literature any findings related to
2 call a "cohort". That's the num ber o f em ployees that
3 other types o f cancer in the Val Chisone workforce, did
3 com prised 1,795 m en w ho had w orked for at least a year
4 they do a good or a bad job?
4 in the m ine and/or the factory betw een 1946 and 1995.
5
A W ell, I'm not aware they tried to edit out,
5
So they basically did the same kind o f study
6 because the prepublication version is as close to
6 but with a larger population.
7 identical to the final published version, and in the
7
Q A nd w hat did they conclude in 2003 as it
8 topic o f mesotheliom a, very clearly there were no
8 relates specifically to mesotheliom a, w hich is the
9 deaths.
9 issue in front o f us in this case?
10
Q Now, you can set that one aside.
10
A W ell, in a sim ple four-line sum m ary they
11
M R PANATIER: H and it to me, please.
11 concluded:
12
M S FROST: O f course.
12
"This study provides additional support for
13
M R PANATIER: Thank you.
13 a n association betw een talc in m in in g an d m illin g and
14 B Y M S FR O ST :
14 non-neoplastic respiratory d is e a s e ..."
15
Q D r R ubino's study is not the only study that
15
Q Stop there. W hat does that mean?
16 relates to the occurrence o f m esotheliom a in talc
16
A W hat they noted was that there were an increase
17 m iners a n d m illers; is th at correct?
17 in som e respiratory diseases in m iners and millers.
18
A Y es, that's correct. O ther people in the
18
Q Does that go back to the silica issue that was
19 m in in g o f co sm etic grade, p harm aceutical grade talcs
19 being discussed in som e o f those earlier docum ents?
20 have certainly looked at the health o f their employees
20
A It is recognized that, certainly back in the
21 over --in m any different m ines around the world.
21 early days, there w as a significant am ount o f dust in
22
Q And in connection with the Rubino study, that
22 the m ine, and that w ould certainly raise the chance o f
23 first one w as published in 1976?
23 respiratory disease, or w hat they call "non-neoplastic
24
A W as it '76?
24 respiratory disease".
25
M S FROST: M r Panatier, what is the
25
Q A nd w hat did they conclude concerning
Page 1228
Page 1230
1 publication date?
1 neoplastic respiratory disease?
2
M R PANATIER: W hat?
2
A Then they go on to say:
3
M S FROST: The item.
3
"... w hile show ing no significant excess risk
4
M R PANATIER: This one? The official
4 for lung cancer and mesothelioma".
5 publication date? M arch, '76.
5
Q D id they find any m esotheliom a in the miners
6
M S FROST: A nd I apologize. I try not to do
6 and m illers in their report from 2003?
7 that, but since w e're sharing docum ents, you'll have to
7
A Let me refresh m yself...
8 forgive me.
8
N o, they didn't, no.
9
Q N ow , D r Rubino did follow up studies related to
9
Q 2003 w asn't the last tim e that a researcher
10 the m iners and m illers, did he not?
10 looked at the w orkers w ho had w orked as m iners or
11
A H e and his colleagues, or certainly his
11 m illers in V al C hisone; correct?
12 colleagues as th e y ears p rogressed, yes.
12
A That's correct. The sam e team plus one two
13
Q A nd there is a follow up o f the m ortality study
13 others, th ey lo o k ed a t the sam e m ine operation w ith
14 o f talc m iners and m illers in Italy from 2003, is there
14 even m ore people b y 2013 -- 2017.
15 not?
15
Q I'm handing you w hat I have m arked as num ber
16
A That's right. The sam e m ine, but m ore people.
16 250.
17
Q A nd I have m arked this as 249.
17
(Exhibit 250 m arked for identification)
18
(Exhibit 249 m arked for identification)
18
Are you fam iliar with this paper published in
19
W ho w as the lead author on the follow up in
19 2017 that's entitled M ortality o f Talc M iners and
20 2003?
20 M illers from Val Chisone, Northern Italy?
21
A M aurizio Coggiola.
21
A Y es, I've read this paper, yes.
22
Q All right, and how do w e spell Coggiola?
22
Q A nd w hat is this paper taking a look at?
23
A C-O -G -G -I-O -L-A . H e's an M D .
23
A The aim o f the study was to update the analysis
24
Q W hat did M r C oggiola and his colleagues look at 24 o f m ortality in talc m iners and millers in northern
25 in the 2003 publication?
25 Italy, and they looked at the m ortality from 1946 to
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1 2013 o f 1,722 m ale w orkers in an asbestos free talc
1 the Verm ont talc business.
2 m ine, o f w hich 1,166 w ere m iners and 556 were millers. 2
Q As an aside, w hat w ould be the anticipated
3
Q Is this the same or a different group of
3 levels of exposure to talc for someone working as
4 employees that were evaluated first by D r Rubino and
4 either a m iner or a m iller in a cosmetic talc m ine?
5 then later by D r Coggiola?
5
A They w ould vary.
6
A It's an update o f the group. S o m e -th e re
6
The m iners are exposed traditionally to quite
7 w ere probably som e additions.
7 high levels. Certainly going back to pre-w ar tim e, the
8
Q W hat conclusion, and who is the lead author on
8 quality o f w ork environm ent in the mines was much
9 this one?
9 dustier than it is today. Today there's m ore forced
10
A The lead author was also on the 2003 paper,
10 ventilation, so the air is less dusty.
11 E n rico P ira, M D . P-I-R -A .
11
W hereas the m illers, w orking above ground,
12
Q W hat do the researchers report in 2017
12 are going to b e exposed to m uch less talc dust.
13 co ncerning th eir findings related specifically as to
13
But in both cases there is a pretty well
14 m esotheliom a in the talc m iners and m illers from the
14 eight h our day exposure to som e level o f talc dust on a
15 V al C hisone area o f n o rthern Italy?
15 daily b asis for m any, m any, m an y years.
16
A They concluded simply:
16
Q W as Johnson & Johnson aware o f the Selevan
17
"W e confirm the lack o f association between
17 study in 1979?
18 exposure to asbestos free talc, lung can cer and
18
A Y es, yes. This has been in the com pany files
19 m esotheliom a".
19 since it w as available.
20
Q So w hat does that m ean in plain English?
20
Q W ere you familiar with this study w hen began
21
A It m eant that those m illers and m iners working
21 your w ork in 1976?
22 in that environm ent did not get m esotheliom a or lung
22
Clearly, you w ouldn't have anticipated it in
23 cancer associated w ith their work.
23 '76, but as part o f the jo b that you did as a
24
Q You m ay set that aside.
24 toxicologist, did you becom e familiar with this report
25
The health status o f m iners and m illers who
25 in the tim e period w hen it w as published.
Page 1232
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1 deal with talc have been evaluated in areas other than
1
A I did, yes. I m ean, it's part o f the jo b to
2 just Italy, have they not?
2 keep up to date w ith the m edical literature. So I was
3
A They have, yes. There are talc mines in
3 certainly aw are o f this one in '79, '80, yes.
4 several countries that m ine cosm etic grade talc.
4
Q You m ay set that aside, and I will hand you
5
Q I'm going to hand you num ber 51.
5 num ber 248.
6
(Exhibit 251 m arked for identification)
6
(Exhibit 248 m arked for identification)
7
Are you familiar with this document?
7
W hat is num ber 248?
8
A Yes, I've read this m any times.
8
A It's a publication from a m edical journal.
9
Q A nd w hat is this?
9 It's the Journal o f Occupational and Environm ental
10
A This is a report from Selevan and colleagues, a
10 M edicine, and it's from 2002, and the title o f the
11 U n ited States report, d ated 1979, a n d th ey lo o k at
11 article is A C o h o rt M o rtality an d N ested C ase C ontrol
12 M o rtality P a tte rn s A m ong M in ers an d M illers o f
12 Study o f French and A ustrian Talc W orkers.
13 N o n -asb estifo rm T alc, a n d this is a prelim in ary report.
13
Q So we have Italian from Rubino, Coggiola and
14
Q W hen you say miners and millers in the United
14 Pira. T hen w e have A m erican from Selevan.
15 S tates, does th a t include an y o f th e a reas w here the
15
This one is French and Austrian?
16 W indsor m ine w as located?
16
A French and Austrian employees, yes.
17
A It did include. Yes, it was done as part o f
17
Q And who was the first author on that one?
18 th e V e rm o n t H ealth D ep artm ent's surveys.
18
A It's M r P W ild.
19
So it relates to the Verm ont talc industry.
19
Q W -I-L-D?
20
Q W hat did Selevan and his colleague D r D em ent
20
A Yes.
21 and others conclude concerning the incidence o f
21
Q W hat did the researchers conclude concerning
22 m esotheliom a am ongst the workers in the m ines in
22 the risk o f health effects to French and Austrian talc
23 Verm ont and their exposure to talc?
23 workers as part o f their evaluation?
24
A They concluded that there was no association
24
A They sum m arized in tw o lines:
25 betw een m esotheliom a and m iners and millers w orking in 25
"The m ortality from non-m alignant respiratory
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1 disease was found to be related to high cumulative
1 general population.
2 exposure to talc dust. The sm all excess in lung cancer
2
Q A nd w hat did they conclude concerning the
3 does not seem to be attributable to talc".
3 existence o f mesotheliom a?
4
Q Do they find any mesotheliom a?
4
A Just let m e double check...
5
A Ju st let m e check, p l e a s e ...
5
They don't report m esotheliom a as a cause o f
6
No, in both the Austrian cohorts they found
6 death. There's no m ention o f m esotheliom a as a cause
7 no cases o f mesothelioma, and in the French group they
7 o f death.
8 found no cases o f m esotheliom a.
8
Q So no m eso reported?
9
Q Are you fam iliar w ith this docum ent, sir?
9
A N o meso reported, no.
10
(Exhibit 246 m arked for identification)
10
Q If one w ere to exclude the original Rubino
11
A Yes, I rem em ber this.
11 stu d y from the list o f epidem iological studies related
12
Q A nd w hat is this?
12 to the relationship betw een talc m iners and m illers and
13
A This is a publication in the Am erican Journal
13 the developm ent o f m esotheliom a, w ould it change the
14 o f Industrial M edicine from 1990 and it is from a
14 conclusion at the end o f the day concerning the
15 N o rw eg ian talc m ine, a cosm etic talc m ine.
15 relationship betw een exposure to cosm etic talc and the
16
The author is Ebba W ergeland.
16 risk o f the developm ent o f m esotheliom a?
17
Q Y ou're going to have to spell that one for me.
17
A N o, it wouldn't.
18
A Y eah. W ergeland. W -E-R -G -E-L-A -N -D , and he oi 18
I m ean, in all these cases w e have several --
19 she is an M D.
19 certainly w ell over 2,000 em ployees exposed to quite
20
Q And you said that is Norw ay?
20 high levels o f talc dust pretty well all day for 20 or
21
A It is in Norway. Yes, it is Norway, yes.
21 m ore years, and in no case was m esotheliom a ever
22
Q W hat were they studying in the Norw ay
22 reported.
23 employees?
23
Q W hen you combine the historic testing done both
24
A They were essentially looking for the health o f
24 internally by Johnson & Johnson and externally by its
25 employees w ho w ere exposed to talc dust as part o f the
25 consultants with the epidemiological findings o f the
Page 1236
Page 1238
1 their job.
1 m edical researchers w ho have looked at the issue o f
2
They looked for mesotheliom a, tuberculosis,
2 developm ent o f disease amongst those who w ork all day
3 pneum oconiosis, lung disease in general.
3 in their w ork day with cosm etic talc products, what
4
Q A nd w hat did they conclude concerning the
4 does that lead you to conclude on behalf o f Johnson &
5 health status o f the Norw egian talc workers?
5 Johnson concerning the risk for development o f
6
A W ell, this was a group o f 94 talc miners and
6 m esotheliom a for users o f its cosmetic talc products?
7 295 talc m illers exposed to non-asbestiform talc, and
7
A Okay. I'm trying to sum m arize that in a couple
8 they com m ented that:
8 o f sentences.
9
"M esotheliom a, tuberculosis or pneum oconiosis
9
It's clear that in none o f the analyses o f
10 w ere not reported as a cause o f death".
10 baby powder talc has anyone found asbestos, and if we
11
Q So no mesotheliom a?
11 lo o k a t som e real life exposure o f people w ho've been
12
A N o m esotheliom a.
12 exposed to quite high levels o f talc dust every day o f
13
Q Are you fam iliar with this one, sir?
13 their lives fo r 20, 30 or m ore years, and no cases are
14
(Exhibit 247 m arked for identification)
14 there reports o f mesothelioma.
15
A Yeah, this is a follow up from the sam e team,
15
Q During the years you worked for Johnson &
16 D r W ergeland in Norw ay. This one is dated 2017 and
16 Joh n so n a n d w ith all the in teraction y o u 'v e had w ith
17 it's published in the A m erican Journal o f Industrial
17 their scientists and the outside experts, w hat w as the
18 M edicine.
18 consensus o f the scientists, both at Johnson & Johnson
19
Q The same set o f Norwegian workers?
19 and on the outside consultants, concerning health risk
20
A It's the sam e workers, yes.
20 for users o f Johnson's cosm etic body pow ders?
21
Q W hat did they conclude?
21
A Assum ing and presum ing that consumers use the
22
A It's essentially a longer follow up w ith m ore
22 product as directed and in a norm al consum er fashion,
23 workers.
23 there w as zero health risk.
24
But they followed up for 24 years, covering
24
Q W hen you talk about "consumers", we talk about
25 1953 to 2011, and they compared the workers with the
25 them in sort o f a hypothetical way.
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1
But as an employee o f Johnson & Johnson, were
1
A It does, yes. That's been the case since the
2 you a user or consum er o f those products yourself?
2 1940s w hen the com pany set up what they call a "company
3
A A bsolutely, yes. I m ean, I've had th re e - - w e
3 credo".
4 have had three - m y wife and I have three children.
4
Q W hat's that?
5 W e certainly used baby powder.
5
A It's an interesting little one page document,
6
All three o f m y children are m arried and have
6 and it's g ot about four paragraphs.
7 families. B etw een them there is an additional eight
7
It was initiated by the then Chairm an o f the
8 grandchildren and I know that I can go into any o f
8 company, General Johnson, and he set out the guiding
9 their hom es and they use talc pow ders, m ostly Johnson's 9 principles that all em ployees have to follow to ensure
10 B aby Powder.
10 that the com pany perform s well.
11
M y m um, w ho passed away a few months ago,
11
Q A nd how does that relate to this?
12 alm o st 99, she u se d Jo hnson's B ab y P o w d er p retty w ell 12
A W ell, the first principle says that we have a
13 all h e r life.
13 responsibility to the users o f our products, nurses,
14
So from a personal view, I have never had any
14 doctors, m um s, babies, et cetera, and the products
15 co ncern fo r m y se lf o r m y fam ily in u sin g b ab y pow der. 15 sh o u ld be safe.
16
Q In connection with the com pany view o f the
16
That's the first principle.
17 efficacy a n d the safety o f Jo hnson's B aby P ow der, yo u
17
Q O ver the years, has Johnson & Johnson kept
18 are here as the corporate representative.
18 abreast o f the developm ent o f the scientific and
19
So w hat is Johnson & Johnson's position, as
19 m edical literature as it relates to talc?
20 w e sit here today, concerning the status o f its
20
A I believe so, yes.
21 cosm etic talc products and the potential for the
21
Certainly, if you look through the company
22 existence o f asbestos in those products?
22 files, you w ill find a lot o f correspondence, a lot o f
23
A The com pany is very clear. There is not and
23 im portant information on the safety o f talc, published
24 never has been any asbestos in the talc products, and
24 in the m edical literature from symposia, meetings.
25 the products are safe to use.
25
There is a great deal o f talc safety
Page 1240
Page 1242
1
Q Even though they think that, w hy not just
1 information in the public domain, and the com pany has
2 include a warning?
2 ensured that it keeps up to date w ith that.
3
M r Panatier talked to you for a very long
3
Q If you had to tell someone w hat you think on
4 time about warnings.
4 behalf o f the company about the safety o f the baby
5
Y ou have told us you don't have any concerns
5 pow der or the other cosmetic powders, w hat w ould you
6 about (he product, the com pany doesn't have any
6 tell them?
7 concerns about the product. W hy not ju st throw on a
7
A I w ould tell them that there's no hazard in
8 w arning for the fun o f it?
8 using those products, that they're quite safe to use,
9
A I think the best answ er to that is to recognize
9 and have been since the 1890s.
10 that a w arning should m ean there is an issues. There
10
There's never been any proven issue with
11 is a concern to be avoided.
11 p ro ducts w h en u sed as intended. T h e product is safe.
12
W e seem to put warnings in m any cases where
12
M S FR O ST : Let's go o ff the record.
13 y o u 'v e g o t to q u estio n w a s th at right. I get a cup o f
13
(O ff the record at 3:22 pm )
14 coffee fro m a w ell kno w n store, it says, "C aution,
14
(On the record at 3:29 pm)
15 p ro d u ct m ay b e hot". I k n o w that.
15
M S FROST: D r Hopkins, those are all the
16
B ut in the case o f talc products, there is
16 qu estio n s I'm g oing to have for y o u this afternoon.
17 never a valid reason to say there is a safety issue
17
I am now going to pass the witness and I
18 w ith th is p roduct. So a w arn in g b eco m es in a sense
18 b eliev e som e o f the o th er law yers w ill have som e
19 irrelevant.
19 questions for you.
20
It can actually devalue the nature o f
20
THE W ITNESS: Thank you.
21 w arnings b y having unnecessary warnings.
21
EXAM INATION:
22
So I believe that there is no valid reason to
22 BY M R GAFFREY:
23 have a warning on this product relating to asbestos.
23
Q Hello, D r Hopkins.
24
Q D oes Johnson & Johnson take seriously its
24
A Hello.
25 responsibility to its customers and users?
25
Q M y nam e is M arc Gafffey. I represent W hittaker
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1 Clark & Daniels.
1
A It is correct, yes.
2
You and I have met a number o f times over the
2
Q And in m y review o f those documents, I have not
3 past few days, have we not?
3 seen a docum ent w hich referenced W hittaker Clark &
4 A We have, yes.
4 Daniels as a source o f talc used either in Johnson &
5 Q And you understand I represent Whittaker Clark
5 Johnson B aby Pow der or Johnson & Johnson Shower to
6 & Daniels in this case?
6 Shower; is that correct?
7 A Ido,yes.
7
A That's correct. I've no t seen it used in
8 Q Just from my own understanding, Johnson &
8 m anufacturing operations for either o f those products.
9 Johnson's Baby Powder was manufactured through the Baby
9
Q Okay.
10 Products division of Johnson & Johnson?
10
Just to conclude that area o f questioning,
11 A Yes. Historically, it was termed Baby Products
11 w o u ld it b e true to the b e st o f y o u r know ledge th at
12 division. It became Consumer Products division back in
12 W h ittak er C lark & D aniels w as n e v er a source o f talc
13 the 1990s, but historically the terminology on
13 u se d in the pro d u ctio n o f either Johnson & Johnson B aby
14 letterhead is Baby Products Company.
14 Pow der or Johnson & Johnson Show er to Show er; is that
15 Q Okay.
15 correct?
16
And, likewise, Shower to Shower, which
16
A T hat's correct. A s far as I'm aw are having
17 I understand became --came into production some time
17 read as m any docum ents --n ot quite 170,000 --b u t I've
18 later; is that correct?
18 n o t seen W hittaker C lark D aniels supply as a source o f
19 A It did, yes.
19 product used for sale to the consum er.
20 Q And I think we established the date some time
20
Q A nd that w ould be for production?
21 during the course of this deposition, but it was a
21
A For production, yes.
22 later period?
22
Q A nd y o u had m ade reference --I forget i f it
23 A It was much later, yes.
23 w as D ay 1 or D ay 2 o f your testim ony --to certain mine
24 Q And was that also produced through the Baby
24 strikes?
25 Product division and later the Consumer Products
25
A There w as a m ine strike in the V erm ont m ine in
Page 1244
Page 1246
1 division?
1 the 1980s, as I recollect, yes.
2
A That's correct, yes.
2
Q W as that the only m ine strike, to your
3
Q A nd you are, as you've testified here in the
3 knowledge?
4 past few days, familiar with the suppliers or the
4
A O n the Verm ont m ine, yes, yes.
5 sources o f talc for use in the B aby Product division,
5
Q A nd during that m ine strike, w as it necessary
6 and later the Consum er Product division, throughout
6 for Johnson & Johnson to obtain talc for use in baby
7 your tenure and subsequently in your tim e as a
7 powder and Shower to Shower from some other source?
8 consultant; is that correct?
8
A It was. In fact, for a very short period of
9
A Yes, I read the correspondence that I --has
9 tim e, I think just a few months, they reverted to the
10 b een available to m e to see w ho the suppliers were.
10 historic Italian 00000 talc from the Fontana m ine in
11
Q D uring the past four days o f your testim ony, I
11 Italy.
12 h a v e n o t h e ard y o u reference W h ittak er C lark & D aniels 12
Q Okay.
13 a s a supplier o r a source o f talc to Johnson & Johnson
13
W as there a particular company that sourced
14 for use either in baby pow der or Show er to Show er; is
14 th at talc for use in baby pow der and Show er to Show er
15 th at correct?
15 to Jo h n so n & Jo h n so n fo r pro d u ctio n during the m ine
16
A It's correct. I've not seen W hittaker Clark
16 strike?
17 D an iels' letterh ead o r correspondence in products that
17
A Yeah, the records that I've seen indicate it
18 w e u se d fo r sale to m anufacture S how er to S how er or
18 w as supplied b y C yprus M inerals at that tim e.
19 Johnson's B a b y Pow der.
19
Q I'm going to ask you to assum e for the m om ent
20
Q And, in fact, Johnson & Johnson turned over a
20 that W hittaker Clark & Daniels on M arch 19,1977, sold
21 num ber o f docum ents in this litigation; is that
21 five 50 pound containers o f 141 talc to Johnson &
22 correct?
22 Johnson B aby Products division.
23
A Yes.
23
W ould you have knowledge or an idea o f what
24
Q A n d from w h at I've seen, it's an estim ated
24 that would have been used for?
25 170,000 pages o f docum ents; is that correct?
25
A W ith a hundred per cent certainty I w ouldn't be
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1 sure w hat it w as used for, but that is a very sm all --
1
A N o, it's the sam e --sam e thing. It's too
2 sm all amount.
2 small.
3
It w ould be too sm all to be used in a
3
It w ouldn't --w ouldn't barely go in the pipe
4 m anufacturing operation, but it's the kind o f am ount
4 w ork o f the production operation. So it's too sm all an
5 that would be used in an R& D operation if R& D were
5 amount.
6 evaluating a talc sam ple for a product.
6
Q A n d w hat i f W hittaker C lark & D aniels sold 12
7
It could well have gone to the research
7 fifty pound containers o f 5251 talc to Johnson &
8 laboratory to see i f it's o f value in the company.
8 Johnson? W ould that have been used in production?
9
(Reporter clarification)
9
A Again, that's too small.
10
A research sample.
10
The production operation m ns by m any tons
11
Q A n d R & D stands for R esearch a n d D evelopm ent? 11 p e r operation. H a lf a ton o f talc w o u ld not - w ould
12
A Research and Development, yes.
12 b arely g o into the m achinery. It's too sm all to be
13
Q And i f Johnson & Johnson had to, or w anted to
13 used.
14 use talc 141 from W hittaker C lark, w hat w ould they have 14
It's the kind o f am ounts that the research
15 h a d to do in o rd e r to b e able to pro d u ce th at talc from
15 g ro u p w o u ld use i f th ey w ere evaluating a sam ple o f
16 th a t m aterial?
16 talc.
17
A That w ould have needed to have gone through a
17
Q W hat about, just using odd numbers, 50 pound
18 fairly d etailed valid atio n process.
18 b ag s o r 50 p o u n d containers o f 3440 talc, w ould th at
19
Part o f that would have been to ensure that
19 have been used in production?
20 it m et, as w e've talked about earlier, the
20
A Again, the same - the same applies. A 50
21 specification.
21 pound sack is ju st too sm all to even get through --you
22
But also that it m atched the fragrance that
22 know, it would never be used in the equipment.
23 w as currently being used and that it processed
23
The equipm ent works by tons, not a few
24 according to the w ay the factory w o uld require it.
24 pounds. So those kind o f numbers, 50 pounds, 100
25
It w ould need to -- the product w ould need to
25 pounds, that's the kind o f thing that the research and
Page 1248
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1 be put on stability. The product w ould need to have
1 developm ent group could well be evaluating.
2 been evaluated by consumers.
2
Q So you can state with reasonable certainty that
3
So they could well have --they w ould use
3 if W hittaker Clark & Daniels delivered a 50 pound -
4 those kind o f four 50 pound sacks - could well have
4 50 - 50 - 50 pound containers o f talc to Johnson &
5 been done for a prelim inary evaluation.
5 Johnson, it w ould not be used in production for either
6
Q But it would not have been feasible to Johnson
6 Johnson & Johnson Baby Pow der or Shower to Shower?
7 & Jo h n so n to u se the five 50 p o u n d containers o f 141
7
A Yes, I can. W ith reasonable certainty, that is
8 talc in the production?
8 the case, yes.
9
A No. N o, the production uses am ounts in the
9
Q Thank you.
10 tonnages, not a few hundred pounds.
10
A Thank you.
11
You w ould not have -- you would not have used
11
M R GAFFREY: A nd I appreciate your endurance.
12 th e equipm ent for that.
12
M R PA N A TIER: A ll right. Let's go o ff the
13
It's m ore likely -- and, again, I'm only
13 record.
14 guessing -- it sounds m ore like an R & D project.
14
(O ff the record at 3:39 pm)
15 R esearch a n d d evelopm ent project.
15
(On the record at 3:44 pm)
16
Q A nd you can state with reasonable certainty,
16
EXAM INATION:
17 th en, th at th e 141 talc -- the five 50 p o u n d containers
17 B Y M R P A N A T IE R
18 fro m W h ittak er C lark & D aniels w as n o t used in
18
Q W e're g oing to pro ceed w ith m y questions i f
19 production?
19 no one else on the phone has questions.
20
A W ith reasonable certainty, it's too sm all an
20
The next exhibit is 252.
21 am ount to ship to production.
21
(Exhibit 252 m arked for identification)
22
Q And, likewise, if W hittaker Clark & Daniels
22
Here you go, sir.
23 shipped to Johnson & Johnson Baby Products division
23
A Thank you.
24 three 50 pound containers on January 19,1979, that
24
Q Sir, can you see that this is a letter dated
25 w ould not have been used in production?
25 February 16,1970; it's from D onald Ferry at Chas
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1 M athieu to R obert G Smith at W hittaker Clark & Daniels? 1
Q A nd W hittaker C lark & D aniels is saying they're
2
A That's w hat it says on the letter, yes.
2 prepared supply more; right?
3
Q D o you understand the questions that you were
3
A Yes.
4 ju st given w ere from the law yer from W hittaker Clark & 4
Q Okay. You can set that aside, sir.
5 Daniels; right?
5
W hat I w ant to do is I kind o f - - 1w ant to
6
A Yes.
6 start near the end, because you recall that you were
7
Q Okay.
7 asked to look at the Rubino paper and the
8
So D on Ferry says here to the President of
8 prepublication version; right?
9 W hittaker Clark & Daniels:
9
A Yes.
10
"D ear B o b ..."
10
Q Right. Okay. I'm going to leave this Post-it
11
A nd then he says:
11 o n there.
12
"W e have been reviewing the situation o f
12
And you were shown -- remember yesterday we
13 M etro p o litan T alc C o a n d its future operations here in
13 established R ubino w ro te tw o pap ers in the '70s; right?
14 th is office a n d believe th at because o f the recent
14
A He wrote a paper that was published in the
15 dev elopm ents, th at serious consideration sh o u ld be
15 A m erican Journal o f H ygiene.
16 given to the raising o f price on all grades o f C anadian
16
Q W ell, no, he published one that was published
17 T alc cu rren tly sold. W hile ou r initial estim ate o f the
17 in the Journal o f O ccupational M edicine?
18 situation se e m e d to indicate a m o re gradual approach to 18
A Occupational M edicine, yes.
19 the problem , several things have occurred w hich we
19
Q A nd then he wrote a second one published in the
20 believe m ake it reasonable to increase prices alm ost
20 Society for Occupational and Environm ental Health;
21 im m ediately".
21 correct?
22
That's ju st our context; okay.
22
A Okay. I've not seen that. W as that the one we
23
"The large loss sustained last year by
23 discussed yesterday?
24 M etropolitan was caused by failure o f prices to m eet
24
Q It indeed is.
25 the costs o f producing at South Plain-field. A s you
25
A A nd w hat w as reference for the publication?
Page 1252
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1 are well aware, w e have received the initial order from
1
Q So the reference o f the publication was the
2 Johnson & Jo h n so n o f N e w B ru n sw ick fo r 1100 tons o f ... 2 ex h ib it w h ich I can show you.
3 1615 talc to cover the period o f February 23rd through
3
B ut here's the first one; okay. Rem em ber
4 June 15th."
4 there was a m ortality study?
5
N ow , 1,100 tons is a lot m ore than a couple
5
A Yes.
6 o f 50 pound bags; right?
6
Q A nd a m orbidity study, remember?
7
A It is, yes.
7
A Yes, yes.
8
Q A nd 1615 is Italian talc; correct?
8
Q A nd I asked you the question. I said:
9
A It is, yes. That's m y understanding, yes.
9 m ortality m eans death; m orbidity m eans illness?
10
Q Right.
10
A Correct.
11
"They have indicated great concern to us that
11
Q Right.
12 i f S how er to S how er should m eet w ith g o o d m arket
12
So you were looking at the m ortality study.
13 approval, th ey m ig h t have to increase th is tonnage and
13 T h at w a s the first study; right?
14 w o n d e r ab o u t o u r abilities to supply. W e have assu red
14
A Yes.
15 th em th at w ith the existing bu sin ess w e have in hand,
15
Q 1976 is w hen it actually ended up in the
16 w e could take care o f betw een 2000 and 2500 tons on an 16 Journal o f O ccupational M edicine?
17 an n u al basis."
17
A Yes, and o f course it also discusses other
18
D id I read that right?
18 diseases.
19
A You did, yes.
19
Q Right.
20
Q A ll right.
20
If you want to finish today, you just got to
21
So on the basis o f an actual document, we
21 answ er the questions; okay?
22 know that Johnson & Johnson actually ordered 1,100 tons 22
A Yes.
23 o f Italian from W hittaker Clark & Daniels at som e point 23
Q Okay. All right.
24 before February 16,1970; correct?
24
Now, w hat you were shown by Ms Frost was the
25
A That's w hat it w ould im ply, yes.
25 prepublication copy w hich you and I asked about
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1 yesterday.
1 ju st broken down by m iners and m illers; right?
2
A Yes.
2
A Correct.
3
Q Now , the prepublication copy, that entire
3
Q Okay.
4 packet is dated M arch 20,1978?
4
Because then he has other tables broken down
5
A Yes.
5 by amounts o f exposure; right?
6
Q Now, unless Johnson & Johnson bought D r Rubino 6
A Correct.
7 a tim e m achine, he could not have given them a
7
Q So let's ju st look at -- the easiest one to
8 prepublication copy o f the second article, the
8 look at is m iners and m illers there?
9 m orbidity article, before that article cam e out;
9
A Yes.
10 correct?
10
Q On that page?
11
A And w hat was the date o f the m orbidity article?
11
A Yes.
12
Q M arch 20,1978.
12
Q A nd you can see there's different cancers that
13
A Okay.
13 are reported; correct?
14
Q Okay.
14
A Correct.
15
So w hen you were comparing the
15
Q There are a few elevated cancers, but not by
16 p rep u blication, an d M s F ro st w rote it up there. She
16 m uch in th at publication; is that right?
17 w rote: p republication?
17
A T hat is right, yes.
18
A Yes.
18
Q Okay.
19
Q And publication?
19
Now, it sounded to m e like what you guys were
20
A Yes.
20 trying to do w as to suggest that the data that I said
21
Q The prepublication copy w as for the article
21 didn't m ake it into the m orbidity study w as actually in
22 published in 1979. W e do not have a prepublication
22 the m orbidity study; right?
23 copy o f the one published in '76.
23
A W ell, that's w hat you're saying.
24
Do you have that straight now?
24
Q W ell, that's w hat you guys w ere doing; right?
25
A M ay I look at the exhibit?
25
A That's w hat you're saying.
Page 1256
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1
Q O f course. T here it is, and y o u can see in the 1
Q That's w hat I'm saying you w ere doing; am I
2 top com er the R ubino m orbidity study; right?
2 right?
3
A nd the date on th at is 1978?
3
A I'm not sure how you're interpreting it. S o -
4
A Yes.
4
Q Okay.
5
Q Okay?
5
A --let's pass on that one.
6
A Yeah.
6
Q Sure. Okay. W e'll pass. W e'll come back to
7
Q A n d th e n y o u can see th is is th e p rep u b licatio r 7 that; okay?
8 co py for the m orbidity study; right?
8
A Yes.
9
A T h at is the date, yes.
9
Q So this is the data from the second study that
10
Q Okay.
10 I'm putting in front o f you, all right, and it reports
11
N ow , the m ortality study also had data on
J 1 on cancers o f larynx, oesophagus, stomach; okay?
12 cancers; rig h t?
12
A It does, yes.
13
A Yes.
13
Q A nd you have the data from the previous study
14
Q Okay.
14 there.
15
N ow go ahead and turn to the page that
15
A Yes.
16 M s F ro st flag g ed fo r you; okay?
16
Q Right.
17
So the first study h ad data on cancers?
17
N ow , if you look at the observed and expected
18
A Yes.
18 and you com pare it w ith the second study, it is a
19
Q T he second study, w hich you have seen the
19 different data set; correct?
20 actual publication, did n o t except fo r lung cancer; 20
A It is, and I believe I said h alf an hour ago
21 correct?
21 th at the reports w ere essentially sim ilar.
22
A Yes.
22
Q Except that the raw data from the second paper
23
Q A ll right.
23 never m ade it into the paper; right?
24
So you are looking at the first publication
24
A T hat's an interpretation, yes.
25 an d it has -- w h a t y o u 're lo o k in g at o n th at p a g e is 25
Q W ell, that's a fact, isn't it?
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1
A Y es. It is, yes.
1
A That was their proposal, yes.
2
Q A ll right, sir. Y ou can set that aside.
2
Q Okay.
3
O kay. S o n o w w e're g o in g to ju m p around
3
"The conclusion is based on the human
4 again. W e're g o in g to g o to th e y ear 2000.
4 epidem iology studies that purportedly link Talc use in
5
(B riefly o ff the record)
5 the perineal area w ith ovarian cancer. The web address
6
T his w ill be 253.
6 ... [is yada yada] T he N T P B oard o f Scientific
7
(E xhibit 253 m arked for identification)
7 C ounselors is scheduled to m eet D ecem ber 13 or 14 to
8
H ere y o u go, sir.
8 review the conclusion. A ttention from the press m ay be
9
E xhibit 253 is a m em o b y the C T FA , dated
9 expected before then, how ever, since the report is
10 O cto b er 1 0 ,2 0 0 0 ; do y o u see that?
10 publicly available.
11
A I do, yes.
11
CTFA has contacted a consultant in
12
Q A n d it's fro m L in d a L o retz, w h o w e h ave
12 epidem iology to determ ine i f sufficiently high pow ered
13 d iscu ssed b efo re; right?
13 epidem iologists w ill b e available to question the
14
A Yes.
14 studies being used to support the ovarian cancer
15
Q A n d she's w ith th e C T F A ; true?
15 concern, along w ith a cost estim ate. A crisis
16
A She is, yes.
16 m anagem ent firm has also b een contacted to determ ine
17
Q Y ou have talked som e about the N T P , the
17 the cost o f preparing for the expected public interest.
18 N atio n al T o x ico lo g ical P ro g ram ; right?
18 W h en th is inform ation is received, it w ill be forw arded
19
A Yes.
19 to the T ask Force for review and support."
20
Q A nd ju st to m ake it clear, ultim ately the N T P 20
So the industry was kind o f scrambling to
21 w as considering talc w ith no asbestos in it; right?
21 reply to this; right?
22
A T hat is correct, yes.
22
A Yes, the industry was putting together their
23
Q R ight.
23 position to defend the safety o f talc.
24
So w hen M s F rost w rote on her board, "N TP, 24
Q A nd ultim ately they put forth their position;
25 n o t a c arc in o g e n - talc n o t a carc in o g e n ", th ey w e re 25 right?
Page 1260
Page 1262
1 only considering talc that had no asbestos in it;
1
A They did, yes.
2 correct?
2
Q A nd they persuaded the N TP not to find that
3
A They w ere considering the w ord "asbestiform
3 non-asbestos talc w as a carcinogen; right?
4 free talc".
4
A T hat was the outcome o f the dialogue, yes.
5
Q Right, w hich i f it's asbestiform free, it's
5
Q A ll right.
6 asbestos free; correct?
6
This next one will be som ething - 254. That
7
A Correct.
7 w ill be quicker.
8
Q All right.
8
(Exhibit 254 m arked for identification)
9
A nd you're aware that both the N TP and IARC
9
So this is an email, and, sir, you can see
10 consider talc containing asbestos to be a carcinogen;
10 that this is from R ichard Z azenski and he is at
11 correct?
11 L uzenac; correct?
12
A They do.
12
A Correct.
13
Q A nd Johnson & Johnson w ould agree with that;
13
Q Okay.
14 correct?
14
A nd this is dated January 2 ,2001, so this is
15
A Correct.
15 ju s t a couple o f m onths after th e N T P announced th eir
16
Q A ll right.
16 proposal; right?
17
So for background, here's w hat she said:
17
A Yes.
18
"The N TP background docum ent addressing the
18
Q A nd num ber 1 says:
19 listing o f T alc in the R eport on C arcinogens w as posted 19
"Jim congratulated us for a fine victory, but
20 on the NTP webpage today, with the conclusion that
20 suggested w e not get too confident ju st yet. He
21 N o n-asb estifo rm T a l c ..."
21 confirm ed that the talc session w as quite an
22
So non-asbestos talc:
22 em barrassm ent for N TP but that m ight also m otivate them
23
"... is 'reasonably anticipated to be a hum an
23 to address the talc definition issue w ith greater
24 carcinogen'".
24 resolve".
25
So that w as w hat was proposed by NTP; right?
25
Now , before w e m ove on into the rest o f this
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1 thing, w e've been talking a lot about definitions in
1
A Again, I repeat w hat I said. Johnson & Johnson
2 this case; right?
2 ow n the company, babycenter.com . It was a com pany the)
3
A Yes.
3 purchased.
4
Q W hat is asbestos? W hat is asbestiform ? The
4
Part o f that rem it is that they have zero
5 difference betw een massive tremolite and asbestiform
5 control over w hat is w ritten on the website.
6 trem olite, and so forth; right?
6
So the idea o f influence is --it just does
7
A Yes.
7 not exist, either for or against any com m ent on the
8
Q Now, the industry was using sort o f a
8 website.
9 definition defense with the NTP; correct?
9
Q Johnson & Johnson ow ns babycenter.com ?
10
A That's -- that is possible, yes.
10
A They own the company.
11
Q All right.
11
Q Has no control over them?
12
W ell, if you go down to the second to last
12
A B ut has no control over the editorial content.
13 p aragraph, M r Z azenski, w h o is at L uzenac, n o w Im erys, 13
Q A ll right.
14 says:
14
A nd we're not to read it one w ay or another
15
"We, the talc industry, dodged a bullet in
15 i f Johnson & Jo h n so n links to babycenter.com on the
16 D ecem ber based entirely on the confusion over the
16 Johnson & Johnson.com w ebsite?
17 d efin itio n issue".
17
A W e can interpret any w ay w e wish, but the
18
Do you see that?
18 reality is th at Jo h n so n & Johnson has zero control over
19
A That's w hat he has written.
19 the co n ten t o f the w ebsite, the w ay it's w ritten.
20
Q All right, sir. Y ou can set that aside.
20
Q That's not the question I asked.
21
Okay. Let's go back tow ards the beginning o f
21
The question I asked is: w e're not to take it
22 the questions asked by M s Frost.
22 as any type o f endorsement that Johnson & Johnson
23
Now, you said at the beginning o f your
23 offers babycenter.com as a resource to people on their
24 exam ination and at the end, you said talc is safe for
24 ow n website; correct?
25 use, including baby talc; right?
25
A Again, Johnson & Johnson owns the company, but
Page 1264
Page 1266
1
A Yes.
1 not the content. So w hat is w ritten on the w ebsite is
2
Q Now, I show ed you a website controlled by
2 not endorsed by Johnson & Johnson.
3 Johnson & Johnson yesterday where Johnson & Johnson 3
Q O ther than linking to it and saying: you can go
4 says skip the powder because it can be harmful to
4 here for information; right?
5 baby's lungs; right?
5
A Yeah, absolutely.
6
A W ell, the website is not controlled by Johnson
6
Q So, as you sit here today, people should
7 & Johnson. T hey have zero influence on editorial
7 continue to powder their babies with Johnson &
8 content.
8 Johnson's talc; right?
9
Q Okay.
9
A Yes.
10
W ell, it is called babycenter.com ; right?
10
Q Okay.
11
A Y eah, it's a that com pany Johnson & Johnson
11
Now , you also serve as a consultant in some
12 p u rch ased som e tim e ago.
12 litigation; right?
13
Q Okay.
13
A I have done, yes.
14
A But they have zero control over the content.
14
Q I never asked you the question: about how often
15
Q Okay.
15 do you w ork as a consultant in litigation in term s o f
16
Johnson & Johnson endorses w hat they say;
16 either hours or your total tim e?
17 right?
17
A Probably once --typically, once every six,
18
A It depends how you define "endorses".
18 nine, ten m onths.
19
A s I say, they have zero control over the
19
Q Okay.
20 content. So if you have zero control over w hat is
20
Now, we w ent through a num ber o f studies
21 w ritten, y ou cannot have the grounds to endorse it.
21 yesterday, or tw o days ago, from the '50s and '60s that
22
Q W ell, let me give you a hypothesis.
22 Battelle did where they were looking in the actual
23
W ould Johnson & Johnson be endorsing it if
23 proportion o f the talc process that would ultim ately go
24 they had num erous links to BabyCenter on the Johnson & 24 into the end product, and they were finding tremolite;
25 Johnson.com website?
25 do you recall that?
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Page 1267
1
A They claim to find a type o f tremolite, yes.
1
Page 1269 Internally, the non-talc needles, those are
2
Q N ow , that's m y follow up. Y ou kept saying they
2 tremolite. T hat was w ritten by Johnson & Johnson; do
3 found trem olite and w e don't know w hether it w as
3 you recall that?
4 fibrous or m assive; right?
4
A That was an analysis done in 1971 o f 344L talc,
5
A Correct.
5 and I'm absolutely certain that that w as re-evaluated
6
Q Johnson & Johnson, in response to those
6 and show n to be not asbestos. 344L is not a talc
7 B attelle studies, never went back and said: let us know
7 product.
8 w hat proportion, if any, is fibrous as opposed to
8
Q Right. T here w as a longer story to this;
9 massive; correct?
9 right.
10
A I've not seen that in the literature, although,
10
A Sorry, not a needle talc product with
11 historically, w e k now the an sw er to th at b ecause w e
11 trem olite.
12 k n o w th at th ere w as n o asbestos trem olite in the m ines
12
(Reporter clarification)
13 th at w ere b ein g the source o f supply.
13
Okay. That 344L grade talc was shown to be
14
Q Can we go to the board. Thanks.
14 free from asbestos.
15
So these were the studies w e w ent through,
15
Q W hat w as shown, let's be very clear, is that
16 and from the '50s, and in '48 you w ere asked about that 16 Colorado School o f M ines w ent to a m eeting w ith
17 docum ent. T h at w as ju s t a governm ental do cu m en t th at 17 everybody, including Johnson & Johnson, on 3 A u g u st and
18 sa id there w a s serpentine an d asbestos in V erm ont talc
18 on 6 A ugust they w rote back and said: now that w e w ent
19 generally; right?
19 to that m eeting, w e rem em ber that w e contam inated all
20
A Yes. Certainly back in the '40s, as I've read,
20 the samples; right?
21 th ere w ere som ething like 50 talc m ines in V erm ont.
21
A W hat they said in a follow up: w e've evaluated
22
Q Okay. W ell -
22 the product again and we do not find any asbestos or
23
A N ot necessarily the one that J& J were using.
23 trem olitic talc that's asbestosform in your product.
24
Q W ell, the Battelle studies were Johnson &
24
And that pretty well reflects dozens upon
25 Johnson's tests o f the Italian talc that it w as using;
25 dozens o f different analyses conducted on the same talc
Page 1268
Page 1270
1 correct?
1 source over m any decades. N o asbestos.
2
A That is correct, yes.
2
Q Right. So he got back, rem em bered he had
3
Q Okay.
3 contam inated everything and told Johnson & Johnson;
4
And you don't dispute the conclusions o f
4 right?
5 Battelle; right?
5
A I can only hypothesize, I can speculate, and
6
A No.
6 you can hypothesize or speculate, but it could well
7
Q N ow , for instance, you've said none o f it was
7 have been that they went back and said: hey, we better
8 fibrous, or none o f it was asbestos, and you have
8 check that again. They checked it again and they came
9 continued to say that.
9 out w ith a conclusion that there was no asbestos in the
10
But, for instance, this is ju st one m em o that
10 product.
11 y o u an d I lo o k ed a t in 1967 w here th ey w ere looking at 11
Q The precise opposite conclusion they had
12 so m ebody else's product, an d th ey said:
12 reached tw o m onths earlier; right?
13
"Baby-mate is greater than or less than - - 1
13
A Two months? Two days?
14 can't read anym ore -- .5 p e r cent fibrous trem olite".
14
Q One m onth earlier?
15
R ig h t?
15
A One m onth earlier.
16
A That relates to Baby-M ate.
16
Q Right?
17
Q That's right, and then they said: this com pares
17
A Yeah, because they probably re-evaluated ale
18 to o u r Italian nu m b er 1 talc.
18 found out that they h ad m isinterpreted their results.
19
A The definition o f "compares" is not given
19
Q Now, we also w ent over the fact that Dr Langer
20 there. Com pares could m ean in term s o f whiteness or
20 edited his estim ate o f the am ount o f asbestos in
21 feel. T here's n o necessarily m ineralogical
21 Johnson & Johnson's B aby Pow der dow n; correct?
22 relationship.
22
A Yes, correct.
23
Q Okay. W ell, if you w ant to dispute that one,
23
Q Correct. But he never said it was asbestos
24 let's look a t som e others.
24 free, did he?
25
Let's do -- let's do this one.
25
A I don't think that was the intent o f his
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Page 1271
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1 article, his study.
1
This has reference to our discussion in New
2
Q In fact, he told J& J internally at a m eeting: I
2 Y ork regarding the proposed FD A regulations for talc
3 still think your stuff has chrysotile in it; correct?
3 for food and food packaging m aterials w herein it is
4
A He did, and the reason for that is that Dr
4 stated th a t'... since talc can be processed to rem ove
5 Langer did not have the ability to distinguish between
5 asbestos-form particles, it is prudent to require that
6 chrysotile and chlorite talc.
6 talc w hich is to be used in the manufacture o f food or
7
They give the same reading on the x-ray
7 food pack ag in g be free o f asbestos-form p articles'. I
8 diffraction machine.
8 recall the result o f that study concluded that the talc
9
Q You recall from the m em orandum , and I don't
9 could not be processed to com pletely rem ove tremolite,
10 w ant to have to dig it out, but he did it by x-ray --
10 even b y your m ost technologically advanced m ethods o f
11 h e d id it b y T E M ?
11 beneficiation".
12
A He did, yes.
12
If you'll ju st verify that I read that
13
Q Yes. Okay. A ll right.
13 correctly?
14
TEM , you can't confuse chlorite and
14
A Y ou did.
15 chrysotile, can you?
15
Q All right.
16
A You need to be an expert to look at that, and
16
So Johnson & Johnson has told these folks: we
17 certainly th o se findings w ere n ev er confirm ed b y any
17 can't get rid o f elongate particles, including
18 o th er research.
18 trem olite; correct?
19
Q Okay. So one o f the exhibits that you were
19
A The reference is to a discussion in New York
20 show n w as Exhibit 41, M s Frost brought up the fact that 20 regarding the proposed FD A regulation, and the
21 the talc u sed b y Johnson & Johnson undergoes a 36-step 21 regulation states that talc can be processed to rem ove
22 washing process; right?
22 asbestiform particles. It's prudent to require that it
23
A Yes.
23 not be used. So the FD A are stating that, yes.
24
Q Okay.
24
Q R ight. T he FD A had proposed a regulation to --
25
Now, Johnson & Johnson understands, and of
25 and in that they had said it is possible to remove
Page 1272
Page 1274
1 course you and I talked yesterday about it, the fact
1 elongate minerals, including trem olite; correct?
2 that, regardless o f how m any tim es they w ashed the
2
A W ell, that w as the FD A 's opinion.
3 talc, elongate m inerals still got through into the
3
Q T hat's right, and w h at Johnson & Johnson's
4 final product; correct?
4 o p in io n w as w as no, y o u can 't; right?
5
A Y ou could certainly get talc shards coming
5
A Correct, yes.
6 through and sm all granular talc com ing through in the
6
Q Okay.
7 fines, yes.
7
A ll right, sir. So you can hand that back.
8
Q Including trem olite; correct?
8
In fact, I'll ju st give you the second page
9
A There m ay well be non-fibrous tremolite.
9 and you can verify that Colorado School o f M ines was
10
Q This will be Exhibit 255.
10 echoing the sam e sentim ent?
11
(Exhibit 255 m arked for identification)
11
A Yes.
12
A ll right, sir. B ecause I'm ju st responding
12
Q Okay.
13 to s tu ff o n cross, I d o n't h av e copies, so I'll ju s t
13
Now , if there w as no elongated tremolite
14 give you a copy.
14 present in the talc, they could have sim ply ju st said
15
MS FROST: Okay.
15 th at, b u t th ey d id not; right?
16
M R P A N A T IE R : A ll right, sir. I'm going to
16
A W ell, the sentence states w hat it states.
17 re ad th is to y o u a n d th en I'm g oing to give it to you;
17
Q In neither letter did they say: there is no
18 okay.
18 elongated trem olite in our talc, d id they?
19
A Okay.
19
A W ell, from D esert M inerals, Johnson & Johnson
20
Q Because I only have the one copy; okay?
20 has never used D esert M inerals talc.
21
A Okay.
21
So I'm n o t sure th ey w ould go to th at level
22
Q This is a letter from February 8 ,1 9 7 3 . It's
22 o f m inute detail.
23 from D esert M inerals -- it says an A m erican m ineral
23
Q I f they w eren't using - if they w eren't using
24 com pany, a Johns M anville affiliate - to Bill Ashton:
24 D esert M inerals talc, then they w ould say: w e don't
25
"D ear Bill:
25 know what can be rem oved from your talc; right?
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1
A Again, that's a hypothesis. I f you're given a
1
Q But they never said they m isread this, did
2 quick one paragraph, two sentence reply, you give a two 2 they?
3 sentence reply. You don't necessarily go to the
3
A T hey did not.
4 m inutiae and what can and cannot be done.
4
Q Okay.
5
So I'm not going to specify or hypothesize
5
Let's look at --by thickness, I'm going to
6 w hat m ight or m ight not have been stated.
6 pass on this one.
7
Q You know, a lot o f tim es w hen I ask you a
7
A Thank you.
8 question, and you say that's a hypothesis.
8
Q I'm going to skip som e o f this stuff. Okay.
9
How m any tim es did you tell M s Frost that her
9
Okay. This is Exhibit 56, dated
10 questions w ere hypotheses?
10 Septem ber 25, '72, and this is a m eeting about Show er
11
A W ell, I'm not sure I got questions so m uch as
11 to S how er w ith the FD A ; okay?
12 co m m ent o n th e data.
12
A Thank you.
13
Q Okay.
13
Q A nd you were asked some questions about that.
14
A I think you're providing m e w ith a hypothesis
14
A nd throughout that document, Johnson &
15 an d, as a scientist as w ell, I'll actu ally p ick u p a
15 Johnson is reiterating, th ey are telling the FD A
16 hypothesis and say: that's a good idea, or that's w orth
16 there's no asbestos in Show er to Shower; correct?
17 testing.
17
A Yes.
18
Q Num ber 44 is M cCrone Shower to Shower. You
18
Q Okay.
19 w e re a sk ed a b o u t th at docum ent; correct?
19
A nd w e know, however, that as o f Septem ber 3,
20
A Yes.
20 1971 --w hat's the date o f that?
21
Q Okay?
21
A Septem ber 25, '72.
22
A Yes.
22
Q Okay, so a year earlier M cCrone had identified
23
Q All right.
23 chrysotile in an additive that was going into Shower to
24
Y o u said: w ell, the final says there's no
24 Shower; correct?
25 asbestos, there's no chrysotile.
25
A They reported on a G -l 1 sam ple that they claim
Page 1276
Page 1278
1
W ill you look at the flagged portion o f the
1 to have found chrysotile, but --
2 final report from M cCrone? I highlighted a little bit
2
Q A nd did that --was that reported to the FDA?
3 up there. W hat does that say?
3
A B ut m y recollection, and I don't have the paper
4
A "We have, however, found traces o f chrysotile
4 in front o f me, is that a re-evaluation was done on
5 in G -l 1..."
5 G -l 1 w hich did not confirm chrysotile.
6
It says:
6
That's probably som ething w e could look in
7
"... one o f the additives to Show er to
7 the documentation.
8 Shower".
8
Q W ell, their point is there's no asbestos in
9
Q Right, so if something is an additive to Shower
9 Show er to Shower. That's w hat they're telling the FDA;
10 to Show er, that m eans it's added to it; right?
10 right?
11
A Yes.
11
A They are.
12
Q A nd M cC rone found chrysotile in it; right?
12
Q W e know that, what, a year later the FDA found
13
A A t that point, they claim to have found
13 107,000 fibers o f trem olite p e r gram in S how er to
14 chrysotile, b u t if I m ay respond?
14 Show er; correct?
15
Q It was just a hypothesis?
15
A B y the FD A m ethod at that time.
16
A It was a finding o f a confusion between sodium
16
Q M m m hm m . Okay. So they did find it, right?
17 sesqui citrate, w h ich looks like chrysotile, and that's
17
Y ou alw ays say: well, by that m ethod they
18 m isidentified.
18 found it; right?
19
Q Did they say that there?
19
A I'd like to --before I com m ent on that, I'd
20
A N ot in this one, no. It's on a later one I
20 like to see that FD A report.
21 found that chrysotile can look like sodium sesqui
21
Q I am not going to dig every paper out o f here.
22 citrate in a M cCrone report.
22
A Okay.
23
Q In general - in general, chrysotile can look
23
Q I f you w ant to w e can do it, or I w ill try to
24 like sodium sesqui citrate; correct?
24 rem em ber to do it at the very end; okay?
25
A Correct.
25
A Thank you.
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1
Q It was an optical method?
Page 1279 1
Q Okay.
Page 1281
2
A It was an optical m ethod, yes.
2
A N ot for asbestos, no.
3
Q Yes. It w as optical m icroscopy, so it w asn't
3
Q You ever run a TEM ?
4 XRD?
4
A N o. I said earlier I'm not a transm ission
5
A Yeah.
5 electron m icroscopist.
6
Q All right?
6
People w ho do that are experts in their
7
A But by fibers, you cannot tell whether
7 field.
8 trem olite is a fiber o f trem olite or a sim ple talc
8
Q M mmhmm.
9 fiber.
9
Have you ever done XRD?
10
A nd one o f the issues around talc is that you
10
A N o, I've not.
11 g e t fibrous talc w hich, a s I h av e said before, talc is
11
Q AH right.
12 n o rm ally a plate, a n d w h en y o u roll it up it looks like
12
A I said earlier that's an expert job that people
13 th at, an d y o u get a m isinterpretation th at it's a
13 d o th at ju s t as th eir job.
14 fiber.
14
Q Okay. I'm going to read to you from the cover
15
So I just question the w ord "fiber" and
15 o f E x h ib it 67, w hich is the F D A test th at w e lo o k ed at
16 trem olite together.
16 tw o days ago, and then I'll let y ou look at it.
17
Q You've done that now for four days.
17
Description o f the work:
18
So w hat you're doing now is you're now saying
18
"The 200 comm ercial cosmetic talc samples
19 m ay b e the F D A screw ed u p an d th ey m isidentified talc as 19 ev alu ated b y D r L ew in w ill be tested for asbestos by
20 tremolite?
20 refractory optical m icroscopy. After installation o f
21
A I'm saying that, w ith a m icroscope, you cannot
21 the autom ated x-ray pow der diffractom eter and the
22 identify trem olite w ith an optical m icroscope.
22 high-tem perature differential thermal analyzer,
23
You can identify fiber, w hich under a
23 instrum ent analytical m ethodology will be perfected to
24 m icroscope could be a fiber o f trem olite, could be a
24 a degree that asbestos can be determined reliably and
25 fiber o f any chem ical, any other ingredient that comes
25 speedily at concentrations o f less than one per cent".
Page 1280
Page 1282
1 in a fibrous form.
1
Okay?
2
But com m only you will find fibrous talc when
2
A Yes.
3 you look under a m icroscope because talc on edge looks
3
Q So you're aware o f the different techniques
4 like a fiber. Talc w hen it's rolled looks like a
4 he's using; right?
5 fiber.
5
A Yes, yes.
6
So without seeing the detailed report again,
6
Q H e is using techniques that can identify the
7 w e ju st have it there were 107,000 fibers.
7 m ineral, isn't he?
8
B ut trem olite -- to identify trem olite, you
8
A If he's using x-ray diffraction as an initial
9 need to go dow n to the next level o f --
9 screen.
10
Q I'm going to object to all o f this as
10
Q A n d th at's w h at he's saying. H e's saying he's
11 n o n-responsive.
11 u sin g that, refracto ry optical m icroscopy, w hich also
12
Let's take a break. I'm going to pull out
12 can identify the m ineral, can't it?
13 th at study.
13
A It can, yes.
14
(O ff the record at 4:17 pm)
14
Q Okay.
15
(O n the record at 4:18 pm)
15
A nd high-tem perature differential thermal
16 B Y M R P A N A T IE R :
16 analysis; right?
17
Q Are a m icroscopist?
17
A Yes.
18
A I'm not a m icroscopist. I have certainly used
18
Q W hich you guys actually had a spec for for
19 o p tical m icroscopes in m y w o rk in g life.
19 looking for chrysotile; correct?
20
Q Okay.
20
A Yes.
21
Have you ever looked at talc for asbestos?
21
Q A nd then he says, for num ber 84 --w e saw this:
22
A N ot under a microscope, no.
22
"Sample # 84 contained 107 fibers o f
23
Q Have you ever looked at -- have you ever looked 23 trem olite/actinolite per mg".
24 at --in any substance for asbestos particles?
24
A nd a m illigram is one one thousandth o f a
25
A No.
25 gram; right?
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1
A Yes.
1
A W e reviewed that this week.
2
Q In fact, w ith M s Frost, you looked at the FDA
2
Q W e certainly did.
3 re-evaluation o f the Lew in results; right?
3
Now, you said: I think they must have spiked
4
A Yes.
4 it, right, to put chrysotile in it?
5
Q A nd w hen they did the FD A re-evaluation o f his
5
A You would - to show a decent reduction, you
6 results, they actually found some trem olite - they
6 w o uld n eed to spike it.
7 found trace trem olite in the m edicated pow der as well,
7
Q D o you know w hether they actually say in their
8 didn't they?
8 m ethods that they actually spiked it?
9
A They found trace trem olite, yes. Trace.
9
A That's a - looks like a 30 or 40 page report.
10
Q Yeah, I don't even think I have that on the
10
Q M mmhmm.
11 b oard, b u t I assum e Jo h n so n & Jo h n so n takes issue w ith 11
A But, from m emory, I think they put in
12 th a t finding, too?
12 2 p e r cent to see i f th ey could reduce it.
13
A T here's no record on the Lew in finding that it
13
Q Can you find that for me?
14 w as fibrous trem olite.
14
A It's a m em ory. I can't remember.
15
Q Okay.
15
Q Yeah.
16
A But m y understanding is they found tremolite,
16
(Pause).
17 a n d th at w a s n o t unusual to fin d traces o f non-asbestos
17
A Okay. O n that report I cannot find that they
18 trem olite.
18 spiked it.
19
Q N ow , you have been very clear about this
19
There was certainly a report that I have read
20 distinction from your perspective between non-asbestos 20 where they did spike with either 1 or 2 per cent to
21 trem olite or m assive form trem olite and asbestiform
21 show a reduction.
22 trem olite; right?
22
B ut in this particular report it doesn't
23
A Yes.
23 quote that they've deliberately added or spiked it w ith
24
Q Okay.
24 chrysotile.
25
A nd regardless o f w hat they were finding
25
Q O kay, and let's speak specifically, because we
Page 1284
Page 1286
1 there in the Verm ont m ine and when they were using the 1 should do that - me, as a pseudo-scientist and you as
2 Italian, Johnson & Johnson expended funds to ask Dr
2 an actual scientist; right?
3 Pooley to find two different w ays to get rid o f
3
A Yes.
4 chrysotile and trem olite in V erm ont talc; correct?
4
Q A n d so w h en y o u say th at y o u 're aw are o f a
5
A As a hypothetical question, they did.
5 reference to som ebody spiking a sam ple, you can't even
6
So if there w ere --trem olite were present,
6 say it's w ith regard to w hat they w ere doing here.
7 they asked him to find out how to reduce it, yes.
7
There are discussions o f spiking sam ples in
8
Q Right, and they sent him samples o f the Verm ont
8 order to determine a lim it o f detection with certain
9 talc; correct?
9 tests; right?
10
A Correct, yes.
10
A Yes.
11
Q A nd they also asked him to find out a w ay how
11
Q A nd there are, for instance, we saw that
12 to destroy chrysotile trem olite in it; right?
12 yesterday in the C T FA round robin, they had spiked som e
13
A In talc, yes, and I've been to D r Pooley's lab.
13 sam ples to see i f peo p le could d etect it u sin g J4;
14 H e w ould --h e w o u ld have the trem olite as w ell.
14 right?
15
Q Okay.
15
A Correct, yes.
16
Now, Exhibit 69 is the reagent system that
16
Q O kay, but you don't have --there's nothing you
17 they were trying to set up, and in the docum ent it says
17 can po int to here.
18 th a t th ere w ere conclusions:
18
Y ou've had four days w ith the Johnson &
19
"Chrysotile fiber suppression w as indicated
19 Johnson law yers to find som ething that says those
20 w hile u s in g ... n-butanol-citric acid system ".
20 sam ples w ere spiked, and you haven't, have you?
21
A nd they actually have the results showing
21
A No.
22 the reduction o f chrysotile through use o f each
22
Q Okay.
23 reagent; correct?
23
A But, as you say, there are 170,000 documents,
24
A Correct, yes.
24 and I've not found the m atching one.
25
Q Okay.
25
B ut if I were running a study, I would be
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1 looking to spike it, and I w ould also be looking to
1 respectively.
2 ensure that if it did claim to be chrysotile, it really 2
D r Estrin stated that these products which
3 w as, because they describe it as probably chrysotile, 3 w ere analyzed by D r L ew in and the C T FA com m ittee were
4 probably chrysotile, chrysotile, chrysotile.
4 obtained by D r Lew in prior to 1973 and are no longer
5
So it kind o f implies that it wasn't
5 representative o f com m ercially available cosmetic talc
6 confirmed.
6 products".
7
B ut that's m y opinion.
7
M eaning that w e're still talking about the
8
Q W ell, two say chrysotile and two say probably 8 original Lewin samples; correct?
9 chrysotile, w hich would mean, sir, that two were
9
COURT REPORTER: Sorry, could I just have a
10 confirmed as chrysotile and two were probably
10 m inute?
11 chrysotile; right?
11
M R PANATIER: Yes.
12
A That's w hat it states.
12
(O ff the record at 4:29 pm)
13
Q A nd you know w ho did that test?
13
(O n the record at 4:31 pm )
14
A W as it McCrone?
14 B Y M R PA N A TIER:
15
Q It's M cCrone.
15
Q So the only point there is, first o f all,
16
A Yes.
16 L ew in, all he d id w as X R D ; right?
17
Q Good guess.
17
A Correct.
18
Okay. Y ou can set that aside, sir.
18
Q O kay, and they're saying for X R D the CTFA
19
The next docum ent is 256.
19 agreed w ith L ew in's read on those early sam ples on 14
20
(Exhibit 256 marked for identification)
20 o f 15 o f them ; right?
21
This is regarding M r Lewin. Y ou spent some 21
A Yes.
22 tim e talking about M r Lewin.
22
Q Okay. You can set that aside, sir.
23
A nd they're talking here about him - I'm
23
Okay. So there w as an exhibit w hich was the
2 4 going to h an d it to y ou again, I did n 't m ake copies 24 '73 report fo r - 1 th in k it w as E xhibit 239, the
25 because these were sort o f unanticipated.
25 second Lew in report, the final report.
Page 1288
Page 1290
1
B ut it says:
1
B ut you're saying the cover page w asn't on
2
"D r E strin requested this m eeting ..."
2 it?
3
Now, Estrin is CTFA; right?
3
M S KAGAN: Correct.
4
A Yes.
4 BY M R PANATIER:
5
Q "... for the purpose o f discussing the results
5
Q So apparently it didn't have a cover page. So
6 obtained from the analysis o f 15 coded sam ples o f
6 w e'll m ake that 257.
7 cosmetic talcs that had been sent to the CTFA by the
7
(Exhibit 257 m arked for identification)
8 Division o f Cosmetics Technology on N ovem ber 4,1975". 8
Okay.
9
So that's from the FD A ; right?
9
All I w ant to do here, because a lot o f time
10
A Yes.
10 w as spent on D r L ew in and his results.
11
Q Okay.
11
So A lfred W eissler, w ho's the Acting Director
12
A nd it just says here:
12 for the F D A in 1973, in this letter he says under
13
"The results o f the CTFA analyses by x-ray
13 nu m b er 2:
14 d iffra c to m e try ..."
14
"I chose D r Lew in for this w ork because he is
15
A nd that's X RD ?
15 a n internationally-recognized ex pert on m ineralogical
16
A Yes.
16 chem istry and because he is a m em ber o f the academic
17
Q "... w ere, w ith the exception o f one sam ple
17 com m unity and therefore likely to be im partial in a
18
it
18 co nfrontation b etw een industry and g o v e rn m e n t...
19
So 14 o f 15:
19 [Therefore], his com petence had previously been
20
"... in general agreem ent w ith those obtained
20 recognized by industry (by virtue o f their ow n use o f
21 b y D r SZ Lew in. H ow ever, the results o f the optical
21 him as a consultant) w hich appeared to confer a
22 m icroscopic exam inations o f these sam ples by CTFA and 22 desirable im m unity against possible industry attacks on
23 D C ST could not be com pared due to the usage o f
23 the validity o f the results".
24 differing definitions as to w hat constitutes a fiber;
24
T hat prediction turned out to be wrong. His
25 i.e. length to diam eter ratios o f 5 to 1 and 3 to 1
25 results are pretty well attacked, w eren't they, sir?
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1
A They were, and with good reason.
1 chrysotile", sir?
2
Q W ell, as w e saw from the previous memorandum,
2
A I don't. It's not a norm al scientific term.
3 the results that were looked at betw een the CTFA and
3
Q This is Exhibit 258.
4 L ew in w ere in ag reem en t 14 o f 15 tim es; correct?
4
(Exhibit 258 m arked for identification)
5
A On second review, although w e read this
5
W hat is the date o f that memo?
6 sentence an hour ago: however, D r Lew in points out on
6
A It's A u g u s t...
7 page 2 paragraph 1 o f his table that chrysotile he has
7
Q H ere, let m e hand it to Sharia first.
8 identified in commercial products shows several
8
T here you go, sir. A ugust 10 - is that '80
9 significant differences from classical chrysotile in a
9 o r '83?
10 location o f x-ray diffraction, et cetera.
10
A Eighty-three. August 10,1983.
11
So even D r Lew in is saying that he's having
11
Q All right, and what is that docum ent talking
12 d ifficu lty id entifying chrysotile.
12 about?
13
Q H e's saying it doesn't look like com m ercial
13
A It's called Q uality Assurance Testing o f
14 chrysotile; right?
14 W indsor G rade 66 T alc and B aby Pow der, Form ula 499.
15
A It doesn't look like chrysotile, yeah.
15
Q Right.
16
Q No.
16
So this is in the '80s, and then I
17
A Classical chrysotile, sorry.
17 h ig h lig h ted a ph rase there, b u t w h at does the w hole
18
Q Right.
18 sentence o f th at ph rase say?
19
A nd com m ercial chrysotile, som ething th at is
19
A "Due to the excellent analytical
20 intentionally added to a product such as an asbestos
20
Sorry, I'll start again:
21 product, is going to look a lot different than
21
"Due to the excellent analytical quality
22 naturally occurring chrysotile; correct?
22 history w ith talc w e have accepted W indsor's
23
A Actually used the w ord "classical chrysotile".
23 C[ertificate] o f A[nalysis] on m ost o f the
24
Q O kay. That's fine. Classic chrysotile; right?
24 specification param eters, with only an infrequent audit
25
A He said the sam ples, the chrysotile he
25 conducted at Royston".
Page 1292
Page 1294
1 identified doesn't look like chrysotile, basically.
1
Q Okay.
2
Q A nd w hat I'm asking you is: you don't expect
2
I f y o u turn the page, so this w ould be the
3 chrysotile as it crops up as a naturally occurring
3 audit program for w hen they actually get the talc to
4 mineral as a contam inant o f som ething like talc to look
4 th e p lace w h ere it's b o ttled ; right?
5 like it looks w hen it com es out o f a chrysotile mine;
5
A N o t necessarily, no.
6 correct?
6
Q W ell, it said -- on the front it said, "w hen w e
7
A I w ould expect so.
7 g et it to R oyston"?
8
W e've seen those photom icrographs earlier
8
A Okay.
9 this afternoon o f w hat chrysotile looks like under a
9
Q Is th at w h ere th ey b o ttle it?
10 m icroscope, and it should still look the sam e w hether
10
A I t 's b o t tl e d i n R o y s to n .
11 it's in a sam ple o f p o w d er o r a sam ple o f flour, o r
11
Y o u c a n d o a n au d it o f th e talc after it's
12 w h atev er it m a y be con tam in ated by.
12 b o ttled o r b efo re w h en it's receiv ed in b u lk shipm ent
13
Q So-
13 o n th e - o n th e ra il cars.
14
A Chrysotile is chrysotile.
14
Y ou can still do finished product audit in
15
Q So if w e have a giant pile o f chrysotile, like
15 th e p o ts th at are little h a lf p o u n d pots.
16 y o u w ere sh o w n in the p hoto b y M s F rost, that's w h at w e 16
Q Okay.
17 should see i f w e find it in talc?
17
A I m ean , th at's n o t c le ar from here.
18
A The photographs we were showed about 50 or 100 18
Q Okay.
19 fibers o f chrysotile. T h ey hav e a definition, th ey
19
W hat does that second page say at the top?
20 look like chrysotile, and they have an x-ray
20
A Specification R equirem ent. F irst item is
21 diffraction pattern and a scanning or transm ission
21 asbestos.
22 electron m icroscopic picture that enables a real
22
Q A nd w hat is the frequency o f the audit?
23 expert, and obviously that's im portant, to identify if
23
A T ested b y frequency. It says research and
24 it's chrysotile or not chrysotile.
24 audit.
25
Q D o you know w hat he m eant by "classic
25
Q Okay.
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1
So the only tim e that w ould be tested for
1 level o f assurance.
2 asbestos is by an audit that som eone decides to do so,
2
Q A nd as w e sit here today on D ay 4, you can't
3 or for research; correct?
3 ever having recalled that Johnson & Johnson ever
4
A W ell, it im plies both research and by audit.
4 rejected a lot o f asbestos for --a lot o f talc for
5
Q Right.
5 asbestos content; correct?
6
A Tested by frequency - sorry, tested by
6
A I've never seen that in any docum entation or
7 research. Frequency is audit.
7 literature.
8
Q All right.
8
Q Okay.
9
A That's clear.
9
A ll right, sir. T his is dated M arch 18,
10
Q All right.
10 1976. The subject is The M t. Sinai Sam ples are Old.
11
And how often w ould an audit occur?
11
(Exhibit 259 m arked for identification)
12
A A n au d it is som ething th at yo u 'd do o n the
12
Okay.
13 m ine. It's --th e intention, I believe, is quarterly
13
So take a peek at that, and if you'll go dow n
14 fo r the m in e audit.
14 to the one that is highlighted, can you read that out
15
A n audit on finished product, once it's been
15 loud for us?
16 bottled, that's after it's been audited o ff the rail
16
A W ell, this talks about Colgate.
17 car, that is n ot specified on here.
17
"Colgate has identified a sample o f Cashmere
18
Q W ell, the w ord they used to describe the audit
18 B ouquet as being pre-1971. C olgate [has] changed talc
19 is "infrequent"; right?
19 sources in 1970 a n d ... rep o rted the n ew talc does n ot
20
A Yes.
20 contain asbestos."
21
Q Can you hand that back to me, please?
21
Q Do you know what talc Cashmere Bouquet or
22
A Yes.
22 Colgate used before 1970?
23
Q The other item s outside o f asbestos, they are
23
A I do not.
24 per rail car or a daily composite; right?
24
Q It was Italian 1615.
25
A Yes.
25
T hat's the sam e stu ff you guys used; right?
Page 1296
Page 1298
1
Q Now, the second Langer paper from 1976, or the
1
A Italian 00000.
2 second Langer research on consum er talcums from 1976, 2
Q W hich w e have agreed is the exact same thing as
3 you talked about that; do you recall?
3 1615 AG IT; correct?
4
A Yes.
4
A W ell, you're telling m e that. I've not seen
5
Q And you read some documents where they had
5 the specification for 1615, but I'll take your w ord for
6 found asbestos in different brands, including Cashm ere
6 it.
7 Bouquet; right?
7
Q W e saw three documents yesterday, and this
8
A That's w hat it read, yes.
8 perhaps - you've seen a lot o f docum ents, in fairness;
9
Q A nd you pointed out that they hadn't found it
9 okay.
10 in Johnson's B aby Pow der during that test; correct?
10
A Yes. Thank you.
11
A I believe so.
11
Q W e saw one that said 00000 is the exact same
12
Q Okay.
12 thing as 1615 A G IT , w hich then becom es the exact sam e
13
So m y question is: you have taken issue w ith
13 th in g as Supra.
14 D r Langer's abilities, m ethodology, you've already done 14
Do you recall that?
15 it w ith m e today.
15
A Yes, that's right, yeah.
16
So w hen he finds the asbestos in your product
16
Q Okay. A ll right.
17 a n d says th ere is asbestos there, I tak e it you're
17
So 00000 is 1615; correct?
18 say in g w e shouldn't tru st him , y o u disagree w ith him ;
18
A Yes.
19 b u t w h en h e d oesn't find it, w e sh o u ld agree w ith him ?
19
Q A nd if Cashm ere Bouquet was using 1615 during
20
A N o, I don't say that at all.
20 those years, w hich I w ill ask you to assume, then that
21
W e m ay be comparing two different sources o f
21 w as the pow der that w as found to be containing asbestos
22 talc. It could well be that the Johnson & Johnson
22 b y Langer at that tim e, if w hat I'm saying is correct?
23 product, having audited the m ine, having taken samples 23
A Yes.
24 o f the m ine, taken sam ples from the factory, taken
24
Q Okay. All right, sir. You can set that aside.
25 samples o f the finished product, you develop a high
25
This w ill be Exhibit 260.
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1
(Exhibit 260 marked for identification)
1 am ount o f asbestos in the cosmetic versus the
2
This is a memo from March 30,1976, telephone
2 industrial.
3 conversation with FD Pooley, and for context, and then
3
Is that correct?
4 I'll show it to you, it says:
4
A As fines, yes.
5
"Langer has spent two days in Pooley's
5
Q Okay.
6 Laboratory in Wales re-examining the OTC products
6
A Yes.
7 reported in the Washington Post. According to Pooley,
7
Q Now, did Johnson & Johnson ever ask M cCrone to
8 Langer agrees now that the level o f amphibole reported
8 re-evaluate those reports?
9 were too high. For example, Langer now feels that the
9
A No.
10 Cashmere Bouquet Body Powder has 4% amphibole (in line
10
Q Okay.
11 with McCrone and Pooley) and not 20% amphibole".
11
A But w e've described them as fibers is rather
12
Can you take a look at that?
12 high. W hat w e've not stated that's com ing out o f that
13 A Yes, and, in fact, the sentence goes on:
13 report, a t least it's n ot on the board, is w hether
14
"There ... [was] evidently still disagreement
14 those fibers w ere asbestos fibers o r talc fibers.
15 between Langer and Pooley as far as the products that
15
Q H ere. L et m e help orient you back to this,
16 Langer reports low levels of amphibole and Pooley finds
16 because I know it's been a long w eek, b u t this is w hat
17 none detectable levels".
17 they said.
18 Q Okay. All right. Sir, I want to get you done
18
Fibers o f asbestos and confirm ed asbestos.
19 today; okay? So you got to just answer the questions I
19 Y ou can't get m ore clear than that, can you?
20 ask, please.
20
A A nd that's in the industrial talc.
21
A I'll answer the question.
21
Q N o, it's not.
22
Q Okay. Thank you.
22
W e can break those out again.
23 A I agree with what you've highlighted.
23
I f you're going to decide to change --
24
Q Okay. Thank you.
24
A N o, I'm ju st - - 1 m ean, it w as three days ago,
25
And so whatever was in Cashmere Bouquet at
25 so w e're looking at that.
Page 1300
Page 1302
1 that time, in that early production pre-71, Langer,
1
Q Okay. Sir, do we --can you agree that in
2 Pooley and M cC rone all agree it's 4 per cent am phibole; 2 these tw o reports it said that there w as confirm ed
3 correct?
3 asbestos both in the fines and in the sediment?
4
A Yes. Amphibole. Yes.
4
Can w e agree to that, or do I have to get the
5
Q All right.
5 paper out?
6
In Exhibit 220 and 221, you said that you
6
A No, w e can agree to that.
7 believed that those were --those designations there,
7
Q Okay.
8 the W M I, w ere industrial talcs?
8
A nd can w e agree that in the next report it
9
A That was m y --that w as m y feeling, yes. Yes,
9 said there were fibers o f asbestos in the fines and in
10 G rade 76, yes.
10 the sedim ent? C an w e agree to that?
11
Q Okay, because it wasn't G rade 66; right?
11
A W e can agree to w hat was w ritten in that
12
A Yes.
12 report, yes.
13
Q Okay.
13
Q All right.
14
Now, w e actually have a comparison M cCrone
14
So w hat we know when we had a direct
15 d id b etw een som e industrial talcs an d som e cosm etic
15 co m parison o f cosm etic talc a n d industrial talc b y
16 talcs; correct?
16 M cC rone, w as that there w as m ore asbestos in the
17
A Yes.
17 cosm etic talc th an there w as in the industrial;
18
Q Right. H ere I'll go back up to the board.
18 correct?
19
So that was these two m em os in middle and
19
A That is w hat's reported.
20 late 1975.
20
Q Okay. W e can set that aside.
21
Any time they looked at the fines, w hich we
21
T his dead air is m e skipping stuff, so that's
22 talked about the fines versus the sediment, w hen we
22 good news.
23 looked at the fines, there were m ore than two tim es the 23
A ll right. Y ou were asked by M s Frost about
24 fines for asbestos, either confirm ed asbestos or fibers
24 som ething called GRAS, w hich is Generally Regarded As
25 o f asbestos -- there were m ore than two tim es the
25 Safe that is a designation the FDA uses; right?
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1
A Correct.
Page 1303
2
Q T hey have never designated talc for use in
3 cosmetics as GRAS, have they?
4
A They have designated talc for use in
5 pharm aceutical applications and food applications as
Page 1305
1
Q A nd at that tim e, the specification doesn't
2 specify any type o f regular testing for asbestos,
3 obviously, since it doesn't even m ention asbestos?
4
A No. It specifies regular testing for absence
5 o f acicular needles.
6 GRAS.
6
Q In fact, the testing --well, you tell m e what
7
Q Right. They have never done so in cosmetics;
7 type o f testing does it say they should do regularly
8 correct?
8 for testing for acicular needles?
9
A No.
9
A Ifs a m icroscopic test. Y ou look under the
10
Q In fact, in their assessment o f w hether or not
10 m icroscope for a sam ple o f the product and look for the
11 to say th at talc is generally reco g n ized a n d safe an d
11 absence o f acicular needles.
12 som ething y o u m ig h t ingest, th ey d id n o t conduct an
12
Q W ell, here is w hat it says:
13 in halation assessm ent, d id they?
13
"Acicular needle-like crystals. The latter
14
A T hey did not.
14 tw o are undesirable in the talc. T he presence o f large
15
Q Okay.
15 acicular crystals o f heavy cross section in any am ount
16
W hen you said that early on Johnson & Johnson
16 are sufficient grounds for rejection o f the talc. The
17 h a d a general specification, w hich w e'v e seen, th at
17 presence o f sm all am ounts o f pointed crystals w hich are
18 says y o u d o n 't w an t an y particu late really, b u t they
18 still platelets is n ot too serious, and distinction
19 said you don't w ant any needle-like particulate in it;
19 should be m ade betw een the tw o conditions".
20 right?
20
So that's w hat it says; right?
21
A Correct, yes.
21
A Yes.
22
Q Because w hen you're m aking a body pow der, you 22
Q I'm ju st looking here, I m ean, how often were
23 don't w ant anything like that you can feel; right?
23 they supposed to test it, do you know?
24
A Correct.
24
A I think, from m em ory, it does specify how
25
Q But you agree, sir, that fibers o f asbestos,
25 m any --they used fifty pound sacks, and I'm speaking
Page 1304
Page 1306
1 okay, if they w ere hypothetically present, as you've -
1 from m em ory, but I'm sure it does state how m any 50
2 we will put that caveat on it so w e can talk about
2 pound sacks were evaluated and when, but it was part o f
3 it - if those fibers are present and they're there at
3 the process, yes.
4 5 ,1 0 , 20 m icrons long, no one is going to feel that,
4
Q I'm ju st looking at their exam ples o f the
5 are they?
5 photomicrographs.
6
A I don't know . It's an interesting question
6
A M mmhmm.
7 because the hum an skin can basically pick up the
7
Q A nd they're all at 330 times.
8 trigger for one nerve, and a nerve ending in the hum an
8
A Yes.
9 skin is incredibly fine.
9
Q Okay.
10
So it's a physiological question. Y ou'd need
10
Is that w hat they were supposed to be doing
11 to ask a physiologist.
11 w h en th ey d id a n y so rt o f th e periodic testing?
12
Q Okay. So you don't know the answer?
12
A W ell, that w ould be a m inimum.
13
A I do not know the answer.
13
I m ean, I've used regular microscopes m any,
14
Q Okay.
14 m any, m any years and 3 5 0 ,1 ,0 0 0 , those are typical
15
A A physiologist m ay well know the answer.
15 levels at w hich y o u look under a m icroscope.
16
Q All right.
16
Q I'm not asking w hat you look at, sir.
17
The 1946 specification, w hich was I think
17
A W ell, 350 w ould be w hat is on that
18 2 2 4 --E x h ib it 224, it d oesn't hav e an y --it doesn't
18 specification.
19 m en tio n asbestos a t all; correct?
19
Q I am looking --I am asking a question about
20
A No.
20 w hat they did, not what you m ight have done.
21
Q A nd it doesn't m ention asbestiform ; correct?
21
A Okay.
22
A No?
22
Q So the exam ple they have here is 330 times.
23
It mentions acicular.
23
A Yes.
24
Q Right, w hich is needle?
24
Q There w as no specification to look any closer
25
A A general description for those structures.
25 than that; correct?
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A W ell, the specification gives the exam ples, as
1 the sensitivity o f the tool is key; correct?
2 published in a journal, where they use 350 tim es as
2
A It is, yes.
3 being the ideal that w ould pick up needle-like
3
Q A nd if w e had said, look, let's look at the ~
4 crystals.
4 let's look at the last 35 years, going back to 1975 for
5
Q H ere's all I found, okay. The exam ples they
5 Johnson & Johnson talcs, generally, we have a bi-weekly
6 gave are at 330 times.
6 J4 test and a quarterly TEM test, generally; is that
7
N ow , w e can agree if there's asbestos
7 right?
8 present, you could look at something at 330 tim es under
8
A Yes.
9 a m icroscope and you could very w ell m iss it; correct?
9
Q Okay.
10
A The view that I've spoken to m icroscopists is
10
T here are som e caveats. T here are --
11 th a t i f y o u lo o k a t enough fields o f v iew , enough
11 so m etim es it m ight change u p a little bit.
12 vision, y o u sp en d eno u g h tim e looking a t the m icroscope 12
A Yeah.
13 slide, yo u sh o u ld p ick it up.
13
Q B ut that's basically w hat w e have; right?
14
Q W hat's the m inim um w idth o f a chrysotile fiber
14
A Yes.
15 th a t y o u can see w ith optical m icroscopy?
15
Q Okay.
16
A It's in --it's in fractions o f a --fractions
16
A nd the TEM m ethod has always been the 7024
17 o f a m illim eter.
17 T E M ; correct?
18
I can't answ er that question.
18
A Yes.
19
Q So w hat it says here is under 6.4 it says
19
Q A nd the other m ethod has always been J4-1?
20 M icroscopic Structure:
20
A Yes.
21
"Take a sm all quantity o f talc on the tip o f
21
Q Now, another --another thing you brought up
22 a spatula and place on a glass m icroscope slide.
22 was this thing was USP, US Pharmacopeia; right?
23 Distribute in a very thin layer by rubbing and sm earing
23
A Yes, w e discussed that.
24 it gently using the flat side o f another slide. Insert
24
Q A nd you said that USP was another way that your
25 slide under microscope, and exam ine talc crystals at a
25 talc got tested? I w asn't sure?
Page 1308
Page 1310
1 m agnification o f 150..."
1
A No. The U nited States Pharm acopeia offers a
2
So that's the spec?
2 test system for the analysis o f talc for asbestos.
3
A That's the spec.
3
Q A ll right. So w hat does that have to do with
4
Q Right?
4 Johnson & Johnson?
5
A Yes.
5
A W ell, the tw o are virtually identical, in the
6
Q So how m uch asbestos can you see at 150 times?
6 sense that the USP has a stage one using x-ray
7
A Y ou w ould see large fibers o f asbestos.
7 diffraction, and if there's cause, you can m ove to a
8
Q Y ou w ouldn't see the sm all ones, w ould you?
8 stage two, w hich is transm ission electron microscopy.
9
A N ot by that method, no.
9
Q Okay.
10
Q Okay.
10
A A nd that's --that m eets the U SP requirem ents.
11
The next tim e there is any specification or
11
Q So U SP requires transmission electron
12 any tim e th a t is m o d ified is w h en th ey start to develop
12 m icroscopy?
13 J4; correct?
13
A A s a second stage.
14
A Y es, that specific, although, as w e've
14
Q I th in k I have it.
15 discussed, retrospective review s o f sam ples from the
15
I think it's in your pile. I think I w asn't
16 late 1940s b y the b e st m ethods d id n o t indicate any
16 planning to use it.
17 asbestos.
17
H ere it is. Okay. Great.
18
Q W ell, d id P ooley list w hat m ethods w hen h e used 18
So this is Exhibit 229, w hich you've spoken
19 w hen he said he w ent back to '49?
19 about, and on the second page is the procedure for
20
A Yes, he used exactly the same m ethods as he
20 absence o f asbestos, w hich you say is a two-step
21 used in the m ain review o f the m ines.
21 process o f X R D and TEM ?
22
Q W hat were those?
22
A Yes.
23
A From memory, differential - sorry, x-ray
23
Q Take a look at that.
24 diffraction and electron microscopy.
24
A Yes.
25
Q W hen you're looking for som ething very small,
25
Q A ll right.
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Page 1311
Page 1313
1
Now, the first step is a choice between
1
A N o, I've never seen the name.
2 infrared absorption and XRD; right?
2
Q Did you know that Johnson & Johnson put him up
3
A Correct, yes.
3 or nom inated him for this panel?
4
Q If it's non-detect, then you can pass it;
4
A No.
5 right?
5
Q Okay. All right.
6
A U nder U SP system , yes.
6
The abstract says:
7
Q And CTFA is similar because under CTFA if you
7
"In response to a req u est from the U S ...
8 don't see it w ith XRD , you get to pass it and say no
8 [FDA] through the FD A M onograph M odernization Task
9 asbestos; right?
9 Group, the U SP Talc m onograph is being m odernized to
10
A U nder that system, yes.
10 ensure th at the tests for asbestos have adequate
11
Q Okay.
11 specificity".
12
A U nder the CTFA protocol, yes.
12
D id I read that right?
13
Q Right.
13
A Y ou did.
14
A nd sam e w ith this one. If you pass step one
14
Q Okay.
15 b y X R D o r infrared absorption, y o u get to say pass, no
15
A t the end o f there it says:
16 asbestos; right?
16
"T he U S P T alc ... [E xperts'] recom m endation
17
A Yes.
17 fo r revision o f the test fo r A b sence o f A sbestos w ill
18
Q It doesn't m ean there's no asbestos, though;
18 include om ission o f the infrared spectroscopy test and
19 right?
19 in clu sio n o f a rev ised x -ray d iffraction procedure, in
20
A N o. That's w hy it's a good idea to m ove onto
20 com bination with one or m ore m icroscopic evaluations
21 step three.
21 (p o larized -lig h t m ic ro s c o p y ,... [TEM ] o r ... [SEM ])".
22
Q Right.
22
R ig h t?
23
A W hich is optical m icroscopy.
23
A Yes.
24
Q Right, because the problem with infrared
24
Q A ll right.
25 absorption is, w ell, infrared absoiption and X R D , is
25
Go ahead and go to the next page.
Page 1312
Page 1314
1 you've got a relatively high detection limit, m eaning
1
It says:
2 not as sensitive as something like optical or TEM ;
2
"T he infrared spectroscopy (IR ) an d ... [XRD ]
3 right?
3 m ethods, as currently written, can lead to
4
A No, you m ight well pick up other m aterials like
4 false-negative results, w hich could allow talc samples
5 chlorite that they're no concern, but they confuse the
5 w ith asbestos contam ination to pass the Absence o f
6 issue.
6 A sbestos test in the USP Talc Monograph".
7
Q Right, but you can miss asbestos; correct?
7
A false negative means som ething is there,
8
A You m ight do, yes.
8 b u t y o u say it isn't; right?
9
Q All right.
9
A That's w hat it states, yes.
10
D oes U SP require TEM , as you said, sir?
10
Q Likewise, it says --dow n below that it says:
11
A No. Optical m icroscopy.
11
"Even after applying the current USP
12
Q All right. Okay. You can set that aside.
12 m icroscopy m ethod, the an aly st can n o t ru le o u t the
13
So this w ill be Exhibit 261.
13 p resence o f hazardous fibers in a sam ple o f talc. In
14
(Exhibit 261 m arked for identification)
14 addition, the lack o f identification procedures in the
15
Sir, can you see that this is a --w hat's
15 op tical m icroscopy section o f the m eth o d co uld lead to
16 called a Stim uli to the R evision Process, the
16 false-positive results".
17 M o d ernization o f A sbestos T estin g in U S P T alc?
17
Right.
18
A Yes.
18
A Correct.
19
Q Do you see that there's tw o individuals there,
19
Q "This underscores the need to modernize the
20 Julie Pier; do you know who she is?
20 current m onograph for tw o reasons: 1) both the IR and
21
A N o, I've never heard the name.
21 X R D m ethods have relativ ely high detection lim its for
22
Q She works for a company called Imerys. You
22 a s b e s to s ..."
23 know w ho that is; right?
23
A nd Johnson & Johnson agrees with that;
24
A Yes.
24 right?
25
Q A nd D rew V an O rden; do y ou know w ho that is? 25
A Correct.
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Page 1315
1
Q "... a n d ... there is no k n o w n 'safe' level o f
1
Q Okay.
Page 1317
2 asbestos exposure".
2
L et's turn, please, to page 16 o f 21 at the
3
A nd you agree w ith that; right?
3 top. The m iddle paragraph:
4
A That's w hat it states.
4
"There are currently no established safe
5
Q D o you agree w ith it?
5 levels o f asbestos exposure. This underscores the
6
A I think that's based on current knowledge.
6 efforts o f the Talc EP to identify strategies and
7
Q Okay.
7 m ethods for reducing the potential for asbestos
8
Now, go ahead and turn to page 9 o f 21, okay,
8 contam ination o f talc to the lowest feasible levels.
9 and you can see that they have advantages and
9 M ore effective analytical approaches are needed to
10 disadvantages o f each m ethod; right?
10 achieve m uch low er levels o f detection than those
11
A They do. They review each o f the test
11 trad itionally u sed to evaluate asbestos contam ination
12 p ro cesses a n d describe the v alue o r w here they've g ot
12 o f bulk m aterials. T he existing m ethods are not
13 w eaknesses a n d failings.
13 necessarily adequate for assessing the potential health
14
Q Right. So under IR it says:
14 risks o f these m aterials. Research b y the U S EPA and
15
"Cannot distinguish asbestos from
15 o thers h as show n th at disturbance o f m atrices (e.g.,
16 n o n -asbestos form s o f the sam e m in e r a l... [and]
16 soil, verm iculite insulation) containing asbestos
17 detection lim it is unknow n".
17 concentrations identified b y the low er detection lim its
18
R ig h t?
18 o f P L M -- w ell below 1% asbestos by w eight, the lim it
19
A Yes.
19 historically u sed by the U S EPA to define an A sbestos
20
Q ForX RD:
20 Containing M aterial --can generate potentially
21
"Limit o f detection m ay be too high for
21 hazardous exposures (30-32). This issues, while not
22 public health and regulatory purposes".
22 currently evaluated, m ay be particularly relevant for
23
R ig h t?
23 the talc used in powders and cosmetics".
24
A Yes.
24
Okay. Have you read this before, sir?
25
Q And then:
25
A I've not, no.
Page 1316
Page 1318
1
"M ay give false-negative result if used as a
1
Q Okay.
2 screening method".
2
A No.
3
W hich they m ention earlier; true?
3
Q N ext page:
4
A Yes.
4
"Also, exposures to certain nonregulated
5
Q Okay.
5 m ineral such as fibrous forms o f winchite, richterite,
6
U nder Optical Microscopy:
6 and antigorite are o f concern. Recent studies have
7
"Particles o f m illed material m ay be
7 found that such exposures are associated with increased
8 disaggregated and inconsistent w ith typical asbestos
8 risks o f mesotheliom a and other asbestos-related
9 m orphology".
9 diseases ... T he U S P T alc E x p ert P anel agrees th at
10
Now, that means, right, sir, that you m ight
10 exposure risks can and should be m itigated b y revising
11 see som ething th at do esn 't lo o k like asbestos, b u t it's
11 U S P m ethods, w h ich w ill th en allow for m u ch low er
12 b e en disaggregated; right? So y o u m ay n o t recognize it 12 detectio n lim its for asbestos, and i f w arranted, other
13 a s asbestos; true?
13 m inerals".
14
A It's possible. It depends on the skill o f the
14
N ow , you haven't seen this before, but those
15 operator.
15 general com m ents, do y o u agree w ith those?
16
Q Okay.
16
A They're a general sum m ary o f current opinion.
17
"Particles o f m illed m aterial m ay be below
17
Q All right, sir. Y ou can set that aside.
18 th e reso lu tio n lim it."
18
Y ou discussed the FDA 2009 analysis o f
19
M eaning the detection limit; right?
19 various talcs. D o y ou recall that?
20
A Correct.
20
A W e did discuss that, yes.
21
Q A nd then, lastly:
21
Q Now , a few questions about that.
22
"Limit o f detection m ay be too high for
22
First, what do you know about the lab that
23 public health and regulatory purposes".
23 did the w ork on behalf o f the FDA?
24
R ig h t?
24
A The FDA report said - - 1 believe it was AM A, a
25
A That's w hat it states.
25 laboratory.
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Page 1319
Page 1321
1
Q Okay.
1 looked at ten grid openings per sample, that w ould be
2
Do you know whether or not the actual
2 less sensitive than looking at a hundred?
3 m icroscopist that did that w ork is now a paid
3
A Yes. In general, the m ore grid openings you
4 consultant for cosmetic talc m anufacturers?
4 look at, the greater the sensitivity.
5
A I don't know the answ er to that question, no.
5
Q Okay.
6
Q All rig h t
6
Exhibit 235 was the m aterial analysis report
7
Do you know, generally speaking --I think we
7 from C yprus, I think in the early '90s -- '92; is that
8 talked about it on D ay 1 --that, in order to increase
8 right?
9 your sensitivity w hen doing TEM , you take a fixed
9
A Yes. Y es, I've seen this.
10 am o u n t o f m aterial, y o u d isperse it a n d th en y o u p u t it
10
Q Okay, and it ju st says that it passes the
11 o n T E M g rids?
11 asbestos test; right?
12
A Yes.
12
A Yes.
13
Q Right?
13
Q Now , that w ould be one that is done by the
14
A Yes.
14 supplier; correct?
15
Q A nd each o f those grids has tiny grid openings
15
A Y es, it's the rail car evaluation.
16 th at you scan; right?
16
Q A nd they're required to do J4-1 on that; right?
17
A Yes.
17
A Yes.
18
Q And, as with anything, the m ore o f those grid
18
Q Okay.
19 o pen in g s y o u scan, the g reater y o u r sensitivity;
19
B ecause that's not a quarterly test. That's
20 correct?
20 ju st your regular test; right?
21
A Correct.
21
A Yes.
22
Q Right.
22
Q A ll right.
23
I think we saw that Blount said she did
23
A n d so y o u said a "rail car te s t".
24 several hundred grid openings w hen she did her paper;
24
N ow , I asked you earlier, generally, you had
25 correct?
25 a test --composite test every two weeks and then a
Page 1320
Page 1322
1
A Sure, yeah.
1 quarterly TEM . Y ou m entioned a rail car test.
2
Q T hat w ould give y o u a higher sensitivity than 2
Are you now saying that all the rail cars
3 ju st doing a few grid openings; right?
3 were also tested by J4?
4
A Yes.
4
A N o, I ju st used the w ord "rail car test" as
5
Q Okay.
5 being the finished product that's shipped in bulk from
6
O r, because people som etim es say low er
6 the holding silos.
7 sensitivity is better, right, higher w ould be less
7
Q A ll right. So w e w ould expect those to have
8 sensitivity; right?
8 been subject to the bi-w eekly test?
9
A Yes.
9
A That's, yes, correct.
10
Q Okay.
10
Q Okay. So w hen it checks that it passes the
11
So the m ore grid openings y ou look at, the
11 analysis, th at is the bi-w eekly test pe r J4; correct?
12 greater th e sensitivity?
12
A Yes.
13
A Yes.
13
Q A ll right, sir. You can set that aside.
14
Q A ll right.
14
Now, J4-1 is the test that both the Johnson &
15
D o y o u k n o w h o w m a n y g r i d o p e n in g s t h a t th< : 15 Johnson a n d th e F D A k n o w g ot an F m inus o n its round
16 contractor looked at for the F D A test in 2009?
16 robin in 1977; correct?
17
A I d o n 't reco llect read in g th at in th at report.
17
A If used alone, yes.
18
Q Okay.
18
Q Okay.
19
In fairn ess, it's n o t in th a t rep o rt. S o I'm
19
A Yes, w ithout TEM , yes.
20 ju s t asking if y o u know from anything else?
20
Q That's right. Okay.
21
A G o o d . N o , I'm g la d m y m e m o ry isn 't g o in g . 21
Exhibit 240 was a statement that M s Frost
22
Q No.
22 show ed you regarding --by Eierm ann regarding Seymour
23
A N o , I d o n 't reco llect read in g that.
23 Lew in; correct?
24
Q Okay.
24
A Yes.
25
I f - can w e generally agree that, if he only
25
Q A nd Eierm ann, o f course, w e've established w as
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Page 1323
Page 1325
1 a form er Johnson & Johnson employee; correct?
1
H ere you go, sir.
2
A Y eah, you stated that. I w asn't aw are o f it.
2
A Thank you.
3
Q W ell, I pointed it out to you on a Johnson &
3
Q Sure.
4 Johnson m em o; right?
4
Okay. So from tim e to tim e, citizens, in
5
A You did, yes.
5 groups or alone, they write to the FDA and they ask
6
Q Okay. A ll right, sir. Y ou can set that aside.
6 them to do things, such as m aybe take something o ff the
7
Exhibit 244 was a m eeting betw een FDA and
7 m arket or put a warning on a product; right?
8 Rohl and Langer that you were show n by M s Frost.
8
A They do.
9
(Briefly o ff the record)
9
Q Okay.
10
A nd D r Langer demonstrates his -- one o f his
10
So if you'll look at that page, at the bottom
11 m ethodologies here, a n d I hig h lig h ted a section.
11 it's g o t a P D N 1, b u t it's the th ird page overall.
12
Can you go ahead and read that out loud for
12
A Yes.
13 us?
13
Q A ll right.
14
A Okay. This is -- let's ju st check the date on
14
So the FD A responds to this individual,
15 w h ich rep o rt it is. It is the rep o rt o f a m eeting
15 P h ilip D ouillet; right?
16 betw een D r L anger and D r R ohl and tw o people from the 16
A They do.
17 F D A , M arch 2 2 ,1 9 7 6 .
17
Q A nd they say:
18
W hat you have underlined under the heading o f
18
"FDA recognizes that asbestos inhalation over
19 T rem olite, it states that:
20
"Dr Langer demonstrated by preparing a slide
19 extended periods is hazardous to hum ans. T he agency 20 II
21 o f C ashm ere B ouquet talc. U nder the m icroscope
21
L et me ask you this: is 40 years an extended
22 trem olite was observed as short particles with 90
22 period?
23 degree cleavage. A nthophyllite had the sam e cleavage
23
A Yes.
24 but was definitely fibrous, having aspect ratios
24
Q Okay.
25 ty p ically 30 o r 40 to 1".
25
"The agency is also aware that some cosmetic
Page 1324
Page 1326
1
Q All right.
1 talc produced in the 1960s and early 1970s did contain
2
So Langer is showing the FDA - by w ay o f
2 asbestiform minerals. However, your petition has not
3 exam ple, he's using Cashm ere Bouquet, but he's found
3 persuaded us that the cosm etic talc that is presently
4 trem olite in it and fibrous anthophyllite; correct?
4 being produced contains significant amounts o f
5
A H e's claim ing to have found, yes, trem olite and
5 asbestiform minerals".
6 am phibole. Yes, he's claim ing that.
6
R ig h t?
7
Q Right, and the w ord "claiming" is yours; right?
7
A That's w hat it states.
8
A It is, yes.
8
Q Now, the FD A knows that when the CTFA did their
9
Q Okay. A ll right.
9 round robin in 1977, they were using 1976 production
10
A Certainly, as w e know at this time, there was
10 pow ders; correct?
11 deb ate as to w h a t peo p le w ere identifying, a n d w e've
11
A Yes.
12 seen th at before.
12
Q A nd that at least three o f those w ere positive
13
Q W ell, that doesn't say there's a debate or he's
13 u n d e r J4; correct?
14 claim ing. It says this is w hat he found; right?
14
A Yes.
15
A T hat's w h a t he's --yes, th at's w h a t he's
15
Q Okay.
16 reporting.
16
Go to the next page, please. In the second
17
Q Okay, sir.
17 paragraph about halfw ay in:
18
One o f the other things you were asked to
18
"By 1976 asbestos analytical m ethodology was
19 look at w as a Citizen's Petition from 1986.
19 sufficiently developed th at the Cosm etic T oiletry and
20
I think there should be a - - 1 have the copy
20 Fragrance A ssociation (CTFA) could issue a
21 that w as handed to me.
21 specification (copy enclosed) for cosm etic talc. This
22
D o you have your copy over there? It's
22 specification required that such talc be free o f
23 Exhibit 245.
23 fibrous am phibole (e.g., asbestos in the form o f
24
Let m e come behind you.
24 asbestiform trem olite) using a CTFA m ethod o f analysis
25
(Briefly o ff the record)
25 that is capable o f detecting 0.5 per cent o f amphibole
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Page 1327
Page 1329
1 asbestos. This specification contributed to the
1
A Yes.
2 continuing im provem ent o f cosm etic talc quality".
2
Q Or, "Being redone"?
3
So he's citing J4; correct?
3
A Being redone, yes.
4
A Correct.
4
Q A nd then we have the new one where all the
5
Q All right, sir.
5 percentages are removed?
6
A nd that was -- that was one o f the things
6
A Correct.
7 that the FD A wrote to this m an and then, o f course, if
7
Q Right. Okay.
8 you turn a few pages, you can see CTFA J4 -- sorry, you 8
L et me show you som ething. This was in the
9 can see their spec for cosm etic talc; right?
9 documents you guys gave us.
10
A Yes.
10
This would be 262.
11
Q And then for fibrous amphibole, if you go
11
(Exhibit 262 m arked for identification)
12 acro ss, th ey sp ecify C T F A J4-1; right?
12
Now , you can see this is a November 26,1990,
13
A That's w hat is stated, yes.
13 letter from M cC rone to C yprus; right?
14
Q Right, sir. Y ou can set that aside.
14
A Yes.
15
So even though there were tw o guys from the
15
Q A nd it discusses three samples that were sent
16 FD A at that m eeting w here J4 failed m iserably, the FD A 16 to M cC rone for asbestos analysis; right?
17 is n o w tellin g som eone in 1986 th at they're actually
17
A Yes.
18 citin g J4 as o ne o f the reasons for im p ro v ed talc; is
18
Q A nd it says:
19 th at true?
19
"Examination found no quantifiable amounts o f
20
A It's true to say th at J4 has contributed to
20 asbestiform minerals".
21 im proved talc, yes.
21
R ig h t?
22
Q A nd w e know that later in 1977 M r Schelz from
22
A Yes.
23 Johnson & Johnson actually recom m ended increasing the 23
Q A nd there's three samples: CW M 90-28; 90-29; and
24 am ount o f allow ed fibrous trem olite and anthophyllite;
24 90-30.
25 correct?
25
So the ultim ate report that Cyprus gets back
Page 1328
Page 1330
1
A I believe we m ay have seen that as a com m ent in
1 is no asbestos; right?
2 a note, yes.
2
A That's the cover page, yes.
3
Q A llow ing anthophyllite up to 2 to 4 per cent;
3
Q Okay.
4 rem ember that?
4
Then you see the letter from Cyprus to
5
A Yes.
5 M cCrone w here they say: here's the sam ples; right?
6
Q Okay.
6
A Yes.
7
Now, M cCrone --Johnson & Johnson asked them
7
Q The next page lists the three samples: 90-28;
8 to revise at least one report w e put up on the board,
8 90-29; and 90-30; right?
9 the one that gave the percentages o f trem olite in the
9
A It does, yes.
10 baby pow der that they looked at; right?
10
Q T hen --you're looking at the correct page, I
11
A I don't know whether they w ere asked to revise
11 th in k -- a t the top it says E P A L evel I I T E M A nalysis;
12 o r asked to com m ent, b u t there w a s a -- there w as a
12 right?
13 seco n d variance, yes.
13
A Yes.
14
Q Yes.
14
Q It says the client ID is CW M 90-28; right?
15
So rem em ber the chain o f events was the
15
A Yes.
16 rep o rt com es to Johnson & Johnson, it gives the
16
Q A nd we know from the cover that they say it
17 percen tag es o f trem olite, a n d th ey d escribe th em as
17 co ntains n o asbestiform m inerals; right?
18 "rods" in tw o sam ples o f Jo hnson's B ab y Pow der;
18
A Yes.
19 correct?
19
Q Now, look down at the count sheet and look at
20
A Correct.
20 the space for grid 56.
21
Q Then there's a note on it that says, "Do not
21
Do you see that?
22 use this report"; right?
22
A Yes.
23
A Yes.
23
Q It says the structure is F, w hich is fiber;
24
Q Then we have another handwritten note that
24 type, A for asbestos; length, 20 --that's microns;
25 says, "M cCrone report being revised"?
25 right?
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1
A Yes.
1
A Yes.
2
Q W idth, 1.5; right?
2
Q Okay.
3
A Yes.
3
So the first one, 20 and 1.5 is far m ore than
4
Q A nd then under SA ED and ED S, it says check 4 3 to 1; right?
5 mark, check mark, anthophyllite; right?
5
A It is, yes, yes.
6
A Yes.
6
Q A nd here it is actually identified - the
7
Q Twenty to 1 is a fiber; right?
7 structure is identified as a fiber; correct? F? See
8
A Yes.
8 that?
9
Q B y anybody's definition; right?
9
A Yes, yes.
10
A Yes.
10
Q Okay.
11
Q Okay, and that is a fiber o f anthophyllite;
11
A nd under O SH A , it's a m inim um o f 5 microns;
12 right?
12 right?
13
A By -- on a 20 to 1 ratio, yes.
13
A Yes.
14
Q Yeah.
14
Q So this w ould be a fiber under OSHA?
15
A Yes.
15
A Yes.
16
Q O kay, and if you turn to the next count sheet, 16
Q Okay.
17 there's a couple o f ED S readouts there.
17
The last one w as shorter. It was 1 m icron
18
The next count sheet is for Cyprus 90-29;
18 long; right?
19 right?
19
A Yes.
20
A Yes.
20
Q Okay.
21
Q Okay, and you don't see any structures
21
So that's not a countable fiber under OSHA?
22 identified on that count sheet; true?
22
A No, it is not, no.
23
A No.
23
Q Okay.
24
Q Okay.
24
So let's ju st talk about the first one you
25
G o to the last one, w hich should be for
25 brought up. That's a countable fiber under O SH A and
Page 1332
Page 1334
1 90-30.
1 according to Johnson & Johnson; correct?
2
You see structure, F fiber, type C
2
A It is, yes.
3 chrysotile, length, 1, w idth .15, m eaning th at's about
3
Q Okay.
4 8 to 1. S o m eth in g like that; right?
4
And yet somehow the report from M cCrone back
5
A Yes.
5 to W indsor says, "No quantifiable am ounts of
6
Q Okay.
6 asbestiform minerals"; right?
7
And it says SAED, check mark, EDS, check
7
A Yes.
8 mark.
8
Q Okay. Y ou can set that aside, sir.
9
So that's a fiber o f asbestos; correct?
9
Y ou said this - - 1wrote this down - you
10
A I'm not a m ineralogist. Y ou know , I'm not
10 should report on w hat you find?
11 g oing to co m m en t on that. Y ou n e ed to a sk a
11
A Yes.
12 m ineralogist.
12
Q A s a scientist; right?
13
There have been - 1ju st tell you w here I'm
13
A Yes, absolutely.
14 com ing from . O S H A have defined the m inim um w idth, th ; 14
Q I f y o u fin d som ething, you n eed to rep o rt it;
15 m in im u m len g th for a fib er to b e defin ed as asbestos.
15 right?
16
That's - 1 can't rem em ber w hat the O SH A
16
A Yes.
17 d efin itio n is a t th is p oint, so it's p ro bably a
17
Q T hat goes for any scientist, yourself included;
18 q u estion to ch eck w ith a m ineralogist.
18 right?
19
Q W ell, let's do that, then. Let's take -- let's
19
A Yes.
20 actually take Johnson & Johnson's definition, w hich
20
Q It goes for McCrone?
21 happens to be the O SH A definition.
21
A Yes.
22
Remem ber on the first day I show ed you under
22
Q It goes for Rubino?
23 test m ethod 7024, fiber by J& J w as defined as 3 to 1
23
A Yes.
24 parallel sides.
24
Q Okay.
25
D o you remember that?
25
Do you agree that the act o f supplying
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1 information to the FD A can be ju st as deceptive as
1 things in duplicate or -
2 providing none if you provide incom plete information?
2
Q H ow m any -- for any studies that were done for
3
A I'm going to use the w ord again,
3 Jo h n so n & Jo h n so n th at show ed n o asbestos, h o w m any dii i
4 "hypothetical".
4 Johnson & Johnson go back to the researcher and say:
5
The act o f providing inform ation to the FDA
5 you had better redo this?
6 is --depends on w hat kind o f information.
6
A I don't know if anyone has ever used those
7
M y understanding o f the records that we've
7 w ords, "Better redo this".
8 gone through in the last four days is that Johnson &
8
It w ould not be unusual in any analytical
9 Johnson have provided a very large am ount of
9 study, w hether it's m icrobiology o r w hatever it m ay be,
10 inform ation to FD A w hich Johnson & Johnson considered 10 to question the study you've got, and say: does this
11 to b e v a lid a n d relev an t to the product.
11 so und right? Is this really the reality? Is this
12
I'm not aw are that any inform ation has been
12 reflectin g the p ictu re w e'v e h a d fo r the last ten
13 deliberately w ith h eld th at th e co m p an y has felt should
13 years?
14 have b een seen b y FD A .
14
So you m ay well go back to the lab and say:
15
But, again, I'm talking hypothetically.
15 w ould you check this, please?
16
Q W ell, let's go back to m y question in which,
16
Q I'm not asking a general question. Iw a s
17 w hich w a s a general question.
17 asking a very specific question about Johnson &
18
A Okay.
18 Johnson.
19
Q W hich is: the act o f supplying partial
19
A re you aw are o f any tim e w here Johnson &
20 inform ation can be ju st as bad or worse than supplying
20 Johnson asked any o f its consultants to redo a negative
21 none; correct?
21 study?
22
A Okay.
22
A I'm not aw are they've asked them to do a
23
Q G enerally speaking?
23 negative --redo a negative study.
24
A W ell, partial information, you should supply
24
Q Okay.
25 inform ation, partial or full, w hen you're sure o f its
25
W e saw a few tim es where they asked them to
Page 1336
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1 veracity, its correctness.
1 redo a positive study; correct?
2
Q W ell, let's say - let's say you have both
2
A T hey w ere asked to check the veracity o f the
3 positive and negative results, right, and the FDA wants
3 results.
4 to know is there any -- for instance, in this case, is
4
Q Right.
5 there any asbestos in the talc?
5
H ow m any tim es were they asked to check the
6
W e know they w anted to know that; right?
6 veracity o f a negative result? Ever?
7
A T hey did.
7
A I've not see that, no.
8
Q Okay.
8
Q All right.
9
A They do, yes.
9
Y ou're not an epidem iologist, are you?
10
Q A nd so if someone had both positive and
10
A No.
11 n egative tests and only su pplied th e negative, th at
11
Q Do you know how big o f a population o f m iners
12 w o u ld b e m isleading to the FD A ; correct?
12 you w ould have to have to be able to have sufficient
13
A It w ould be supplying insufficient information.
13 p o w e r to actu ally determ ine w h ether or n o t there is a
14 You w ould not be supplying the full picture.
14 relationship betw een inhalation o f talc in a m ine
15
Q Right.
15 settin g a n d m esotheliom a?
16
A Yes.
16
A I've not review ed -- you know, that's an
17
Q A nd it w ould be biased information; correct?
17 epidem iological question.
18
A That's an interpretation, yes.
18
W hat w e do know is w e've got over 2,000 talc
19
Q A nd you w ould agree w ith that interpretation?
19 m iners and m illers w ho have had a --often a lifetim e
20
A If the inform ation that was being withheld was
20 exposure, 25, 3 5 ,4 0 years in some cases.
21 show n to be true, as opposed to here's a partial
21
Q If I ask you that question, you can give me
22 experim ent, w e haven't finalized it.
22 that answ er, but that's not the question I asked you.
23
it's one o f the tilings in science. People
23
A Okay. Ask the question again.
24 often do a study and they say: I'd better confirm that,
24
Q The question I asked you was: do you know
25 and so you do it again. That's good practice, doing
25 whether or not any o f the studies you referenced had
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1 sufficient pow er to determine whether or not inhaling
1
This will be Exhibit 263.
2 talc in a m ine environm ent was sufficient to increase
2
(Exhibit 263 m arked for identification)
3 the risk for mesothelioma?
3
N ow , som etim es in m edia statem ents, sometimes
4
D o you know the answer to that question?
4 in advertisem ents we see Johnson & Johnson talking
5
A don't. All I read is w hat you read, is that
5 about how their talc is extrem ely pure; right?
6 none o f the miners developed mesotheliom a after a
6
A Yes.
7 lifetim e exposure to talc dust.
7
Q Very pure.
8
Q Right.
8
And under the CTFA standard that was set they
9
And, sir, have you -- are you aware o f any
9 said that the overall - w hatever goes into the bottle
10 studies com paring the quality o f the dust betw een a
10 has to be at least 90 per cent talc; right?
11 m in e setting, w h at is actu ally in the air, an d a
11
A I can't rem em ber, but I'll take your w ord for
12 co n su m er u se setting, w here they're u sin g the refined,
12 it, yes.
13 finely p u lv erized pow der?
13
Q That's fine.
14
Are you aware o f any studies comparing those
14
A A nd the CTFA statement.
15 tw o things?
15
Q W ell, okay.
16
A I've not looked at those studies, no, no.
16
So the extent that Johnson & Johnson's
17
There are studies w hich show the quantity o f
17 standard is any different than that, w hat is their
18 du st in the m ine.
18 standard on h o w m uch o f th e du st th at goes in the
19
Q Sure.
19 bottle is actually talc?
20
B ut you can have --for instance, you could
20
A It should be over 90 per cent, yes.
21 h a v e th e sam e q uantity in term s o f p articles o f tw o
21
Q Okay.
22 totally different dusts; right?
22
A O r thereabouts, yes.
23
A Yes.
23
Q All right.
24
Q B ut those dusts m ight be completely different
24
O ther stu ff m ight be --o f course, we're
25 in their character as far as how fine they are, what
25 talking about asbestos, but it m ight also be the
Page 1340
Page 1342
1 they actually are m ade of; right?
1 chlorite you mentioned.
2
A Yes.
2
A Yes.
3
Q Okay.
3
Q It m ight be little bits o f other accessory
4
M S FRA ZIER: T hey've been disconnected.
4 m inerals; right?
5
M R PA N A TIER: A ll right. W ell, that's a good
5
A Yes, yes.
6 tim e for a break anyw ay, and I'm nearing the end.
6
Q Okay.
7
(O ff the record at 5:30 pm)
7
So this here is --this is one o f those
8
(O n the record at 5:41 pm )
8 docum ents that w as provided to us. It's from som eone
9 BY MS FROST:
9 at --it looks like IITRI R esearch Institute, and it's
10
Q Sir, Exhibit 85 w as the one w here there was a
10 to the FD A , D ecem ber 2 0 ,1 9 7 3 .
11 survey d o n e o f som e com petitors, including Johnson's
11
Take look at that.
12 B ab y P ow der, b u t fo u r o th er com petitors from E keral,
12
A Okay.
13 R ichw ay, R ev co S tork-A id an d K -M art.
13
Q Have you seen that before?
14
A Mmm.
14
A N o, I'm not fam iliar w ith this one.
15
Q A s well as an evaluation o f international talcs
15
Q Okay.
16 and the W indsor float and stock.
16
He is calculating how m any chrysotile fibers
17
I f you'll take a look at the evaluation, this
17 o r how m any am phibole fibers you could have in talc
18 w as a n ev alu atio n o f ju s t am phiboles p e r slide, okay,
18 that is 99.9 per cent pure; right?
19 an d i f y o u take a look at th e bab y pow ders, there's
19
A Yes.
20 five total baby powders evaluated there; right?
20
Q Okay.
21
A Yes.
21
If you'll turn the page, right, and he's got
22
Q O ut o f those five, w hich one had the most
22 a big, long m ath equation there?
23 amphiboles?
23
A H e certainly has.
24
A Johnson's B aby Pow der, L ot PR6139.
24
Q G o ahead and go to the last page. I think he
25
Q A ll right. You can set that aside.
25 has his results, and he calculates results both for
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1 chrysotile and am phiboles; right?
1
Y ou talked w ith M s Frost about sort o f the
2
A Yes.
2 worldw ide talc control program ; right?
3
Q According to his calculations, if you have a
3
A Yes.
4 99.9 --and is it ju st .9 or 99?
4
Q W hen did that start?
5
A O n th is one it says .9.
5
A 1975 w as the first one I can find.
6
Q Okay.
6
Q Okay.
7
A 99.9.
7
Now, I have an undated docum ent here, but if
8
Q 99.9 per cent pure talc.
8 it started in '75, this w ould have to be p o st-7 5 --
9
W hat is his calculation as to how m any
9
A Yeah.
10 chrysotile fibers can still be present in th at talc?
10
Q --because it's entitled A sbestos Occurrence in
11
A H e's claim ing it m ay contain --sorry, it can
11 T alc, C ontrol W orldw ide.
12 co n tain as m an y as 3,500 chrysotile fibers p er
12
It's Exhibit 264.
13 m illigram .
13
(Exhibit 264 m arked for identification)
14
Q Per m illigram.
14
N ow , in the second paragraph here, and I'll
15
A nd for amphibole asbestos, how m any fibers
15 let you see it in ju s t a second --
16 p e r m illigram ?
16
A Thank you.
17
A W ell, for am phibole fibers, he's claim ing it
17
Q - they say:
18 m ig h t contain as m an y as 20,000 am phibole fibers p er
18
"In the US - and Italian-sourced talc, we
19 m illigram .
19 have excellent long-term audit inform ation, control o f
20
Q Okay.
20 specific ore veins, and an ongoing system o f
21
If w e w ant to know w hat that is per gram, we
21 m easurem ent th at w ill tell us i f w e had processed
22 ju st m ultiply each by a thousand; right?
22 asbestos-containing talc".
23
A Yes.
23
A nd you and I have talked about all o f
24
Q So for chrysotile, you w ould have 3.5 m illion
24 that --betw een m yself and you and M s Frost, we've
25 fibers per gram; right?
25 talked about that quite a bit; right?
Page 1344
Page 1346
1
A Yes.
1
A W e have, yes.
2
Q And for amphibole asbestos, you w ould have
2
Q "In other sources, history is scant, control o f
3 20 m illion fibers per gram; right?
3 exact source is less reliable, and ongoing m easurements
4
A Yes.
4 are so m odest that they gave us little confidence".
5
Q O kay, and that's hypothetical. I f you had --
5
B ut look at w hat it says at the very top. It
6
A The w hole --yeah, die w hole thing is a
6 says Present Position, and w hat is their introductory
7 hypothetical.
7 paragraph?
8
Q Sure.
8
A This says:
9
A W hat if, w hat if.
9
"... at present [we] have no control system
10
Q Right.
10 to prevent a s b e s to s ..."
11
A M ay contain. Yeah.
11
In --worldwide.
12
Q N ow , in fairness, w e see a lot o f w hat ifs
12
Q Okay.
13 ab o u t ho w m uch asbestos can b e in a talc product;
13
T hat's not ideal, is it?
14 right?
14
A W ell, obviously, in --this could have been
15
A W e have. In the last tw o or three days, we've
15 pre-'75, o f course, but at that tim e, there w as no US
16 seen a num ber o f hypothetical w hat ifs, yes.
16 control over the talcs in other non-U S countries.
17
Q Sure. Sure.
17
Q Tell m e w hat the title o f the --
18
N ow , w hat he's saying is, if his m ath is
18
A The title is A sbestos Occurrence in Talc
19 correct, that you could claim som ething to be
19 C ontrol W orldw ide.
20 99.9 per cent pure, but that w ould allow for
20
Q W orldwide, and you said that program started in
21 3.5 m illion fibers p er gram o f chrysotile or 20 m illion
21 7 5 ?
22 fibers per gram o f am phibole asbestos; right?
22
A It started in 7 5 as an official program , yes.
23
A Yes. Hypothetically, if it contains that
23
Q Okay. All right, sir. Y ou can hand that over.
24 num ber in the first place.
24
W hat they say here, w hether this was 7 5 or a
25
Q Okay. Y ou can set that aside.
25 little before or after, it says:
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1
"W e at present have no control system to
1
So th is is A pril 1, '77; right?
2 prevent asbestos contam ination at levels detectable by
2
A Yes.
3 T E M in ou r fin ish ed p ro d u c t'1.
3
Q A nd it's done by EM V . W e haven't talked about
4
R ig h t?
4 them yet, have we?
5
A That's w hat it states, yes.
5
A No.
6
Q A nd Johnson & Johnson w as selling Johnson's
6
Q If you look at the photom icrographs near the
7 Baby Powder worldwide at that point; right?
7 back, you can see that they have EDS. This is electron
8
A Yes. The reference doesn't, o f course, state,
8 m icroscopy; correct?
9 but responsibility was left to the individual countries
9
A Yes.
10 to ensure quality.
10
Q All right.
11
Q W ell, the ultim ate responsibility is the
11
A nd w hat they say is they're trying some
12 co m pany th a t puts it on the shelf, a n d th at w as Johnson
12 d ifferent sam ple preparation. T h ey say;
13 & Johnson; right?
13
"It becam e evident during the last set o f
14
A From a legal perspective, if Johnson & Johnson
14 analyses that som e particles o f the largest talc
15 F rance o r Jo h n so n & Johnson G erm any p u t a p ro d u ct on 15 fraction w ere b ein g b iased ag ain st during norm al sam ple
16 the m arket, they have the legal responsibility.
16 preparation. B ecause trem olite is often present in
17
Q A Johnson & Johnson entity; correct?
17 this size fraction and is apparently less susceptible
18
A A Johnson & Johnson entity, yes.
18 to com m inution than talc ..."
19
Q All right.
19
W hat does "comm inution" mean?
20
This w ill be Exhibit 265.
20
A Breakdown.
21
(Exhibit 265 m arked for identification)
21
Q Okay.
22
Now, you said that at some point it became
22
A Yeah.
23 fairly regular to do quarterly m onitoring?
23
Q Right, because, o f course, talc is softer, as
24
A M mmhmm.
24 you say?
25
Q I think w e have one o f those here.
25
A It is, yes.
Page 1348
Page 1350
1
Now , this is --if you look on the very first
1
Q S o it's easier to b reak d o w n talc th an
2 page, or actually the second page, right, do you see
2 trem olite; right?
3 that's highlighted there?
3
A Y es, yes.
4
A Yes.
4
Q "... tw o p rep aratio n s are n o w b ein g exam ined:
5
Q A nd it says Consultant R eport to Johnson &
5 one is as before, another is a slurry o f the bottom
6 Johnson, 9 T alc Sam ples, A pril 1, '77; right?
6 fraction o f talc dispersed and decanted w ith ethyl
7
A Yes.
7 a lc o h o l..." e t cetera; okay?
8
Q That would be the first day o f the second
8
T hey have several different tests. T hey have
9 quarter?
9 D g ro u n d , an d th at's th eir designation.
10
A Yes.
10
I take it that m eans "dom estic ground"?
11
Q Right.
11
A I d o n 't know .
12
A nd it's to Johnson & Johnson, and W indsor
12
Q Okay.
13 m ills; right?
13
A I d o n 't know . I w o u ld n 't com m ent.
14
A Yes.
14
Q T hey have no - nothing detected there;
15
Q Okay.
15 correct?
16
So on the next page it says;
16
A No.
17
"This report gives the results o f analysis
17
Q T h at's o n th e p ag e at the bottom , 8983?
18 fo r nin e talc a n d ro ck sam ples and d iscu sses new
18
A Yeah.
19 p reparation an d exam ination techniques th at have b een
19
Q Is th at correct?
20 im plem ented to supplement previous techniques. Other 20
A Yes.
21 than this, exam ination is as described in previous
21
Q Okay.
22 reports".
22
F or A com posite, and you guys w ere doing
23
I'm going to go to the board, because we
23 com posite quarterly T E M ; correct?
24 haven't talked about this report yet, and w e started
24
A Yes.
25 to. I put the date dow n and then I forgot.
25
Q T h ey say b o th -- I'm ju s t go in g to w rite this
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1 in green so it's easier --they say:
1 num bers o f large trem olite particles. This sam ple was
2
"Both large and small fibrous trem olite
2 prepared as described in the second paragraph o f the
3 particles fo u n d ..."
3 report. Figures 18 and 19 show the tw o types o f
4
R ig h t?
4 sam ples that w ould be prepared for each sample. One
5
A That's w hat they state, yes.
5 fibrous trem olite particle w as found in the larger
6
Q Okay.
6 fraction, Figure 20".
7
For O ld Stock Composite, does that m ean they
7
So one trem olite particle; right?
8 were just testing for a past quarter there?
8
A Yes.
9
A I don't know. It's - - you know, I'm going to
9
Q One non-fibrous?
10 use the w ord "speculate", but I w ouldn't w ant to
10
A Yes.
11 speculate.
11
Q Okay.
12
Q Okay. D on't speculate then.
12
A nd then there's a lot o f pictures, and
13
A Thank you.
13 th ey 'v e g o t som e a t 1,500 tim es, 15,000 tim es. So this
14
Q They say:
14 is electron m icroscopy; correct?
15
"One small, fibrous trem olite particle".
15
A Yes.
16
R ig h t?
16
Q Right.
17
A That's w hat they say, yes.
17
Even if you look at the bottom o f 8988, so go
18
Q Then in Sam ples -- they have something labeled
18 to th at page, 8988, they have som e pictures.
19 Sam ples 14 and 15:
19
Now, m ost o f these old photocopied pictures
20
"Trem olite particles here were found in
20 do n 't com e o u t too w ell; right?
21 several experim ental types o f p rep aratio n s ..."
21
A T hey don't.
22
B ecause they're talking about how they're
22
Q But these two on the left, you can actually see
23 changing up --how they're preparing the slides for
23 there's a big bundle o f trem olite there in the top
24 microscopy; right?
24 left; right?
25
A Yeah.
25
A You can, yes.
Page 1352
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1
Q "...how ever. Fibrous and non-fibrous
1
Q A nd then there's a very long fiber at 5,000 X
2 trem olite are show n in F igures 8, 9 and 10".
2 o f trem olite there on the bottom left; right?
3
So th ey say -- they ju st say som e trem olite
3
A Yes.
4 fo r 14 and 15; correct?
4
Q Okay.
5
A T hey do say that, yes.
5
That's a fiber o f asbestos sir; correct?
6
Q A n d fo r 8 ,9 and 10, again, n o n -fib ro u s - I'm 6
A I w ould say so, looking at that picture, yes.
7 sorry, fibrous and non-fibrous trem olite.
7
Q All right, sir.
8
Is that correct?
8
A B ut can I m ake a comment?
9
A T h at's w h a t's w ritten , yes.
9
Q One second.
10
Q S am ple 16 w as - I'm ju st going to list it so
10
Go ahead and turn to 8993, please. Sorry, I
11 w e 'r e a ll o n t h e s a m e p a g e h e re .
11 h a d one m ore I w an ted to show you.
12
Sam ple 16 w as non-fibrous trem olite.
12
Y ou can see there on the top left there's
13
S o th ey 're g etting a m ixture; correct?
13 an o th er large bun d le o f trem olite fibers; right?
14
A Yes.
14
A Yes.
15
Q T h ey 're g ettin g so m e fibrous a n d som e
15
Q A nd those --they label those as "fibrous
16 n o n -fib ro u s; rig h t?
16 trem olite particles"; correct?
17
A C orrect.
17
A They do, yes.
18
Q N o a s b e s to s in 17 th r o u g h 2 1 , a n d I g u e s s th a t 18
Q Right, sir. Y ou can set that aside.
19 is a t 2111?
19
Now, w hat did you want to say --
20
A Yes.
20
A Yes.
21
Q S o 17 th ro u g h 2 1 - 1 w ill p u t a II b y it:
21
Q --and I'm ju st allow ing y ou to say it. I
22 nothing.
22 didn't ask a question. B ut you can say w hat you w ant
23
A n d then B com posite. T hey say:
23 to say.
24
"T he sam ple represents w hat is hoped to be a 24
A Thank you. Thank you.
25 su ccessful p rep aratio n tech n iq u e fo r d etecting sm all 25
It relates to this, because I have seen this
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1 before and it is addressed to Johnson & Johnson.
1 Talcum Products; do you see that?
2
A t the tim e A pril, '77, Johnson & Johnson
2
A Yes.
3 also ow ned the industrial m ine and they would also have 4 been sending sam ples o f industrial talc.
3
Q Do you see that the authors are Pooley Rohl,
4 Langer, Bowes and Skinner; right?
5
This report, for w hatever reason, doesn't
5
A Yes.
6 state w hat --w hich m ine w as being evaluated. It's an
6
Q So it looks like Pooley, Rohl and Langer, all
7 unknown.
7 these guys actually w rote a paper together; right?
8
It's ju st a com m ent I w anted to make.
8
A Yes. W as this published?
9
Q Y ou're saying you don't know i f that is an
9
Q W ell, that's a good question. W e're going to
10 industrial sam ple?
10 talk about that.
11
A T hat is correct.
11
A Okay.
12
Q Okay.
12
Q So w e w ill get there.
13
W e do know a few things. It's the start o f
13
So, as you can see, this was a evaluation o f
14 the second quarter; right?
14 it looks like both m ine and consum er talc products;
15
A Yes.
15 correct?
16
Q Y ou w ere doing -- you were sam pling the
16
A Yes.
17 cosm etic quarterly; correct?
17
Q Okay.
18
A Y es, b ut w e haven't discussed the industrial
18
Now, you asked m e whether or not this was
19 sam pling.
19 published. I take it, then, you're not aw are if it w as
20
Q W ell, do we have a docum ent here that tells us
20 published?
21 w h a t the in d ustrial sam pling w as?
21
A I'm aw are o f a paper that Pooley authored w ith
22
A No, because I was not deposed to talk about
22 Langer, or a draft paper that was presented or not
23 industrial sam pling, and I don't have that information.
23 presented at a symposium.
24
Q But w ho brought it up, sir?
24
Q Mmmhmm?
25
A N o, I brought it up because this does not state
25
A A nd because Pooley did not agree with the draft
Page 1356
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1 it's cosm etic talc from the cosm etic m ine. It's a
1 th at it w as presented at.
2 bland report.
2
Q Okay.
3
I ju st w anted to note for the record it
3
So i f you turn to the --we'll talk about
4 doesn't state that it's cosm etic talc.
4 w hether it was presented or not, but if you turn to the
5
Q W ell, it also d o esn't state th at it's
5 page --w ell, let's go to the Conclusions, okay.
6 industrial talc, does it?
6
The Conclusion page is the one with the Bates
7
A N o, it doesn't. It's a bland report on talc.
7 stamp 4622.
8
Q Right.
8
A Yes.
9
W hat we do know is it is addressed to Johnson
9
Q Conclusions.
10 & Johnson; correct?
10
1. T he analysis o f tw enty-seven sam ples o f
11
A Correct.
11 raw talc im ported into G reat B ritain an d eighteen
12
Q It is the start o f the second quarter o f 1977;
12 consum er talcum products purchased at retail stores in
13 correct?
13 G reat B ritain h a s show n th at these m aterials co n sist o f
14
A Correct.
14 a variable and com plex m ixture o f m inerals".
15
Q It is electron m icroscopy; correct?
15
So we know that it was 27 samples o f raw and
16
A Correct.
16 18 consum er sam ples; right?
17
Q Johnson & Johnson w as doing quarterly testing
17
A That's w hat's stated, yes.
18 o f th eir talc b y electron m icroscopy; correct?
18
Q It says:
19
A Correct.
19
"Trem olite was found in six o f the forty-five
20
Q All right.
20 samples, in am ounts up to 30% by weight. Three o f
21
(Reporter clarification)
21 these six sam ples w ere consum er talcs. A nthophyllite
22
This w ill be Exhibit 266.
22 w as found in one consum er talcum. Serpentine phases,
23
(Exhibit 266 m arked for identification)
23 possibly including chrysotile, were found in at least
24
Sir, do you see that this is a paper entitled
24 tw o samples".
25 M ineralology and Chemistry o f British Talc and Consume] 25
D id I read that right?
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1 high grade platelet talc and a sm all am ount o f
1 m entioned those going back to the 1950s, '60s, the
2 fragrance. To assure that we obtain the purest talc
2 source o f the talc was the Italian 00000 talc, w hich we
3 available, w e extract ore from our ow n m ines in Verm ont 3 know m ay contain traces o f trem olite.
4 w hich were selected because o f the high quality and
4
B ut based on thorough evaluation, that has
5 purity o f the talc. The talc ore then undergoes a
5 been shown to be non-asbestos tremolite.
6 cleansing procedure know n as flotation that involves
6
So it w ill rem ove impurities. It m ay well
7 m any separate 'washing' operations to rem ove any
7 leave som e trem olite present.
8 impurities w hich m ight be present".
8
Q So I'm going to ask you the question again.
9
N ow , I'm going to stop there.
9
W e know that, first o f all, I asked you this
10
W e know that statem ent is false; correct,
10 question already today --w e know that Johnson &
11 sir?
11 Jo h n so n n ev er said to B attelle o r anybody else: go b ack
12
A The talc undergoes several washing operations,
12 an d decid e w h at portion o f the flotation w h ere you
13 yes.
13 fo u n d trem olite is fibrous versus non-fibrous; correct?
14
Q Right, and his statem ent that it rem oves any
14
A That is correct.
15 im purities is false; correct?
15
Q Okay.
16
A It depends how w e define "any impurities".
16
A Yes.
17
The washing involves removal o f a great deal
17
Q This person from Johnson & Johnson is telling
18 o f im purities, y o u know , the sm all fines, the
18 one o f y o u r consum ers th at the talc is washed; okay?
19 particles, hem atite, iro n m agnetic particles.
19
"... m any separate 'w ashing' operations to
20
T hey all get rem oved, as do sm all, fragile
20 remove any impurities which m ight be present".
21 fragm ents o f talc.
21
To a person that is receiving that letter, a
22
Q M r-
22 lay person, a consum er, the w ay they take that is: they
23
A Those are impurities.
23 git rid o f all the im purities, isn't it, sir?
24
Am I m issing som ething here?
24
A T h at's - w ell, that's p art o f the --the next
25
Q Yes, sir. It's right here on the board.
25 sentence.
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1
These are the results o f the flotations o f
1
Q Hold on. Hold on.
2 Italian talc, all starting back in the '50s, w here they
2
W e're going to get there; okay?
3 were show ing that, even w ith the flotations, the
3
A Okay.
4 flotation system , the w ashing, like they call it;
4
Q H ow a regular person hears that is: hey, they
5 right?
5 get rid o f whatever impurities m ight be present,
6
A Yes.
6 because that's w hat the guys says; right?
7
Q T hey were still getting trem olite in the end
7
A He does, and then he goes on in the next
8 result; correct, sir?
8 sentence.
9
A In the 1950s?
9
Q W hich w e're going to get to, okay.
10
Q In the 1950s?
10
"Finally, the talc is checked by complex
11
A Yes.
11 scientific m ethods including x -ray diffraction,
12
Q Through the 1960s, and, sir, w e have at least
12 differential therm al analysis, and electron m icroscopy
13 tw o letters in the 1970s, on e from C olorado S chool o f
13 w ith electron differentiation to confirm the absence o f
14 M ines, one from H ildick-Sm ith to a federal agency w here 14 asbestos".
15 th ey say: w e can n o t guarantee rem oval o f all elongate
15
R ig h t?
16 particles.
16
A That's rig h t
17
And, in fact, today I showed you the one
17
Q Okay.
18 w here C olorado S chool o f M ines said: w e can 't get rid
18
So this was w ritten in Decem ber 30,1974.
19 o f trem olite; right?
19
So w e have all o f this different testing.
20
A Yes.
20 Johnson & Johnson B aby Pow der ore has trace fibrous
21
Q So the statem ent that w e w ash it and we get rid
21 trem olite/actinolite .001 per cent chrysotile in
22 o f any im purities is a false statement.
22 m edicated pow er is the additive.
23
You m ight get rid o f some impurities, but you
23
.01 per cent chrysotile in Johnson's B aby
24 don't get rid o f any impurities; correct?
24 Powder.
25
A W ell, you m entioned trem olite and, as you
25
W e have --w e have 1 to .5 p e r cent trem olite
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1 and .2 to .3 per cent trem oiite in 108 and 109T.
1
A nd that Johnson & Johnson's goal in their
2
W e have trem oiite fibers that are suspected
2 ow n w ords w as to "control the work"; right?
3 in Johnson & Johnson Baby Powders.
3
A Johnson & Johnson's goal is to actually find
4
W e have confirm ed am phibole in four samples
4 the truth.
5 a t b etw een .001 p e r cen t a n d .01 p e r cent.
5
Q I'm not asking for your words. I'm asking to
6
The FD A study, then. W e have a --w ait a
6 agree w hether or not Johnson & Johnson's w ords w ere to
7 m inute, w hat's the date o f that?
7 "control the work"?
8
A Decem ber, 1974.
8
A It depends how w e define "control".
9
Q 12 m onths earlier, w e started a chrysotile
9
I think I've said this before, the comm ents
10 suppression system w here w e saw chrysotile in the final 10 from D r A shton m ade it also clear that Rubino and his
11 float; correct?
11 colleagues w ere v e ry professional.
12
W e looked at that today; right?
12
They w ould not subject them selves to any form
13
A T hat was --that was claim ed to be the case.
13 o f control. T hey w ere g oing to give an honest
14
Q Okay.
14 appraisal o f their results.
15
So despite all o f that, this is w hat he tells
15
Q D id Johnson & Johnson use the word "control" in
16 this person: that w e get rid o f any asbestos; right?
16 relation to R ubino's w ork?
17
A That's w hat he's w ritten, yes.
17
A A n individual used the w ord "control".
18
Q Then in the second paragraph he says:
18
Q Okay. A ll right, sir. Y ou can set that aside.
19
"It is unfortunate that articles like this
19
Is Johnson & Johnson's current philosophy,
20 appear from tim e to tim e, as they present a sensational
20 right now today, that --o r let's ju st say w ithin the
21 and scary perspective, rather than a balanced and
21 last ten years, okay --in the last ten years, is
22 scientific one. D ata associated w ith talc that is
22 Johnson & Johnson currently still testing the final
23 heavily contam inated with asbestos or other dusts o f
23 product, as opposed to ju st the raw material?
24 course has no bearing on the cosm etic use o f a purified 24
A I believe so.
25 talc like ours".
25
Q Okay.
Page 1372
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1
Now, w e know that the very next year their
1
It is Johnson & Johnson's policy that the
2 ow n study show ed that the cosmetic talc had more
2 final product should be tested?
3 asbestos in it than the industrial talc; right?
3
A I believe that is part o f the audit, yes.
4
A T hat was w hat was w ritten on the chart, yes.
4
Q All right.
5
Q Right.
5
Now, w ho is John Lemmo, L-E-M -M -O?
6
Do you know whether or not M r Infante wrote
6
A I think the name is in the Quality Assurance
7 M s Sorensen back and gave her those results?
7 Department.
8
A I do not know.
8
Q Okay.
9
Q Okay.
9
W ho's M atthew Noble?
10
In the m iddle o f the paragraph it says:
10
A H e's an ex-em ployee in the UK.
11
"The m ost recent inform ation in this regard
11
Q Did you know him?
12 w a s p resen ted b y P ro fessor G F R ubino at the 37th
12
A Yes, I did, yes.
13 C ongress o f the Italian S ociety o f O ccupational
13
Q W hat w as his job?
14 D ise a se s..."
14
A He was a senior scientist.
15
A nd he goes on to talk about that; right?
15
Q Senior scientist. Okay.
16
A Yes.
16
Sorry for the little break there. This will
17
Q D id he disclose that Johnson & Johnson funded
17 b e 269.
18 that?
18
(Exhibit 269 m arked for identification)
19
A Johnson & Johnson m ade a grant to Rubino, not
19
I only have the one copy, so take your time.
20 necessarily full cost o f the work, but they m ade a
20 No, I can bring it up here.
21 gran t to D r R ubino.
21
All right, sir. Here you go.
22
Q R ight. W e saw at one point it w as I think 12
22
A Thank you.
23 or 18,000. A t another point it w as 30,000?
24
A Yes.
23
Q D o you see that's an email sent D ecem ber 6,
24 2009. The subject is Global Talc Specification; right?
25
Q Right?
25
A Yes.
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1
Q A nd it regards a PCPC m eeting in DC.
1 responding to regulatory stuff; right?
2
That's the CTFA?
2
A Y eah. H e's b e en a t P C P C for a few years, yes.
3
A Yes.
3
Q Okay. Do you know him?
4
Q Right.
4
A Id o . I've m et him , yes.
5
It says -- this is M r Lem m o --he says:
5
Q Okay. A ll right.
6
"I did attend the PCPC m eeting in DC
6
Do you know whether or not Johnson & Johnson
7 yesterday. I m ade it a point to have off-line
7 has retained him as an expert witness in litigation?
8 discussions with the attending talc experts (Drew Van
8
A I don't know that, no. Y es o r no, I've no
9 O rden from RJ Lee, Julie Pier from Rio Tinto and Gary
9 idea.
i
10 T om aino fro m S peciality M inerals)".
10
Q Okay.
11
Do you know him?
11
Do you know whether anybody has retained him
12
A N o, I don't know him , no.
12 as an expert in asbestos talc litigation?
13
Q Okay.
13
A I don't, no.
14
W hat does "off-line discussion" mean?
14
Q Okay.
15
A It's probably ju st face it face, like w e're
15
A I m et him but, you know , beyond that I don't
16 having now .
16 k now w hat his d ay to d ay activities are.
17
W ell, no, actually it's not. W e're being
17
Q "This was reinforced in a comm ent from the PCPC
18 recorded. B u t i f the reco rd in g w as o f f an d w e had a
18 rep (John B ailey) w ho re-stated m y assertion that i f w e
19 chat, th at's off-line.
19 control (elim inate) asbestos in the raw m aterial there
20
Q Got you.
20 is no need to test for it in finished products. There
21
"All w ere in agreem ent that current XRD
21 w as no acknow ledgm ent from the FD A on this view ".
22 techniques are appropriate for testing for free
22
Now, do you agree with this proposition by
23 crystalline silica, and that a lim it o f less than 0.5%
23 M r Lem m o that there is no need to test for it in the
24 w as reasonable from the standpoint o f analytical
24 finished products?
25 sensitivity and w hat we can practically expect from our 25
A N o, I th in k h e 's ju s t m aking a suggestion.
Page 1376
Page 1378
1 high grade talc RM s".
1 It's not one that w ould, you know , be accepted, I don't
2
That's raw m aterials; right?
2 think, by his senior management.
3
A Raw materials, yes.
3
Q Okay.
4
Q "The FDA (John Gasper) m ade a brief
4
Because the truth is that the raw material
5 presentation at the talc portion o f the meeting, and
5 testing can absolutely m iss something; correct?
6 m entioned that FD A is soon to complete a contracted
6
A Raw m aterial or m ine? Raw material or m ine?
7 analytical study o f asbestos in US talc raw m aterials
7
Q The m ine testing can m iss something; right?
8 and finished products containing talc".
8
A The m ine testing, yes.
9
A nd we've talked about that today?
9
Q The raw material testing can miss something?
10
A W e've discussed that today, yes.
10
A In theory.
11
Q Okay. Last paragraph:
11
Q A nd even the final product testing can miss
12
"During the Q& A session I pointed out that
12 som ething; right?
13 the d ifficulties in testin g for asbestos i n ... raw
13
A In theory, yes.
14 m aterial beco m e even g reater w h e n testin g a w ide
14
Q Okay.
15 variety o f fin ish ed pro ducts th at contain talc (unknow n
15
And, for instance, I think we can point to an
16 potential interferences, low er overall sensitivity, no
16 exam ple o f this if w e take it at face value, w hich is
17 valid ated m ethods, etc.)".
17 i f w e look a t the report from the independent
18
N ow , there are validated m ethods for testing
18 laboratory from 2004, he studied Johnson's B ab y P o w d er
19 finished products; correct, sir?
19 and found .2 p e r cent anthophyllite asbestos; right?
20
A Yes.
20
A Yes.
21
Q Okay.
21
Q If we take that at face value, that means that
22
"This was reinforced in a com m ent from the
22 the m ine m issed it, the raw m aterials m issed it, and
23 PC PC rep (John B ailey) ..."
23 the final product testing m issed it; right?
24
N ow , John Bailey is one o f the guys w ho works
24
A Yes.
25 at PCPC and helps co-ordinate with industry and
25
Q But that also assumes that all three o f those
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1 tests happened; right?
1 docum ents I've seen, I haven't seen a single one w ith
2
A Yes.
2 your nam e on it if you were involved?
3
Q Because not every pound or every ton that
3
A Okay. They w ould probably be in the UK
4 leaves the m ine is tested; correct?
4 com pany's records, then, in th at case, th at an y
5
A That w ould be impossible.
5 m eetings we had w ith people like Bruce Semple and other
6
Q Right. O f course.
6 colleagues. He w ould visit the U K office or the U K
7
A You w ould never reach the manufacturing plant.
7 facilities. W e'd m eet and I'd get an update.
8
Q Right, and certainly not every ton or even
8
M inutes w ould be held in the UK, if anything.
9 every lot is tested at the plant; right?
9
Q So there should be m inutes o f those meetings?
10
A N ot every ton, no.
10
A I f the m inutes were taken o f any meeting, yes,
11
Q A nd certainly not every bottle is tested;
11 yes.
12 right?
12
Q W ell, w e know that Johnson & Johnson is m inute
13
A N ot every bottle, no.
13 taking com pany; right?
14
Q W e know that at the m ine, they only test every
14
A M aybe in the US. In the UK, things were,
15 65 0 tons --
15 certainly b a ck in the '70s, a little b it m ore inform al.
16
A Yes.
16
Q W ell, we have information certainly going back
17
Q -- by J4; right?
17 betw een the U K branch and the U S quite a b it in these
18
A Yes.
18 papers w e've looked at; right?
19
Q So the prospect o f m issing som ething is
19
A Yes, possible. Yeah.
20 certainly a reality if we take that report at face
20
Q A nd w e've only looked at --I m arked ju st over
21 v alue; right?
21 2 00 exhibits, and w e have w ell o ver a hundred thousand
22
A A theoretical possibility, yes.
22 o f them, o f total documents.
23
Q Okay.
23
A Yeah.
24
A ll right. Now, you said that --you said
24
Q So there should be documents with your name on
25 th at your fam ily use Johnson & Johnson's B aby Powder. 25 it if you w ere involved in talc back then; right?
Page 1380
Page 1382
1 W hen was the first tim e -- well, let m e ask you, you
1
A It depends if those m inutes that w ere taken in
2 said your kids used it?
2 the U K or what have you were transmitted back to the US
3
A Yeah.
3 and what have you.
4
Q I don't w ant to get personal, but w hen were
4
B ut Bruce Sem ple certainly visited the U K
5 your kids bom ?
5 office on m any occasions in the 1970s. W e m et, we
6
A 70 --that's right, they'll never forgive m e if
6 discussed this topic, and I kept up to date with the
7 I g et it w rong --'74, '75, '81.
7 information.
8
Q O kay. All right.
8
Q Y ou discussed the asbestos topic?
9
W hen was the first time that you had
9
A W e discussed talc safety. It was topical at
10 responsibility for talc at Johnson & Johnson?
10 the tim e, as you know . W e've discussed it in the last
11
A Seventy-six.
11 fo u r days.
12
Q O kay, and were you responsible - 1 didn't see
12
Q Sure. Yeah.
13 y o u r nam e o n an y o f th is early s tu ff - w ere yo u
13
But I just w ant to know to w hat extent you
14 dealing w ith the asbestos issue?
14 w ere involved in asbestos?
15
A I was dealing with the safety o f talc in the UK
15
A N ot asbestos, no. W e were involved in talc
16 a n d the E uro p ean perspective --
16 safety, and the inform ation w e've discussed in the last
17
Q Mmmhmm?
17 few days, people like R ohl and L anger and w hat w as
18
A -- as it pertained information crossing the
18 happening w ith the CTFA .
19 A tlantic. I w as involved in dialogue w ith peo p le like
19
T hat was part o f the dialog, ju st essentially
20 B ruce Sem ple, M D. He regularly visited our offices in 20 not that I w ould m ake a m ajor contribution, but that we
21 the U K .
21 w ould b e kept up to date w ith w hat's happening, because
22
So, yes, certainly from that tim e, I was
22 it m ight affect the European operations.
23 familiar with the w hole topic and issue from --right
23
Q It sounds like your involvem ent at all in
24 from the day I started, essentially, w ith J&J.
24 talc - well, in asbestos w ould be in passing at best.
25
Q O kay, b ut I'm ju st --in the 170,000 plus
25
A The involvem ent was in talc safety as it
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Page 1383
1 related to the publications we've been talking about
1
Q Okay. All right.
Page 1385
2 today. Publications in the public domain, Rohl,
2
Does Johnson & Johnson know the total num ber
3 Langer, Lewin, anything that was happening with CTFA.
3 o f Johnson & Johnson talc product users w ho have died
4
That was -- that was shared with myself and
4 or are dying from mesothelioma?
5 our Medical Director.
5
A I don't.
6 Q And when you arrived in 1975 --
6
Q W hat is the total num ber o f Johnson & Johnson
7 A Seventy-six.
7 talc users who have sued you because they are dying of
8 Q -- when you arrived in '76, did you sit down
8 mesotheliom a?
9 and go through all of the historical testing of Italian
9
A I don't know the answ er to that.
10 and Vermont talc for asbestos?
10
Q Okay. Certainly, Johnson & Johnson has that
11 A No, no.
11 inform ation; right?
12 Q Okay.
12
A I don't. Yes, it is possible that the Legal
13 A Not at that point in time, no.
13 D epartm ent m ay w ay. I can 't an sw er th at question.
14 Q When did you --when did you start to
14
Q Y ou w ere asked about --you w ere asked for this
15 appreciate that there was -- and I'll use the word
15 com m ent: ab o u t w arnings. D o y o u recall talk in g about
16 "controversy", because that's the word Johnson &
16 w arnings?
17 Johnson uses, but a controversy about asbestos in talc?
17
A I do, yes.
18 A Well, controversy came about with Dr Rohl, Dr
18
Q A nd M s Frost said --she brought up the concept
19 Langer, Dr Lewin in the early '70s, and then the
19 o f w arning ju s t for the fun o f it; right?
20 ongoing dialogue between CTFA, between CTFA and FDA.
20
A Yes.
21
That was a topic for discussion that we had
21
Q Okay.
22 with Dr Semple back in the mid-'70s, late '70s, yes.
22
If there w as asbestos in anybody's talc, m uch
23 Q Okay. So you became aware of it some time in
23 less Johnson & Johnson's, and they knew about it, the
24 the mid to late '70s?
24 m anufacturer knew about it, there should be a warning
25 A From when I joined the company.
25 on it; right?
Page 1384
Page 1386
1
Q Okay.
1
A If a talc product was deem ed unsafe by medical
2
A I rem em ber it w as one o f the first topics w e --
2 experts, scientific experts, it w ould be reasonable to
3 as a toxicologist, it w as a case of: you need to get up
3 w arn, or even n ot to sell it.
4 to speed with w hat's happening out there.
4
Q Correct, and in fact if Johnson & Johnson talc
5
So, yes, from the m id-'70s onward.
5 pow ders had asbestos in it, they shouldn't have been
6
Q Right.
6 sold at all; correct?
7
A So m id-'60s --'76 onwards.
7
A If they had asbestos that was dangerous and the
8
Q Okay.
8 product w asn't safe, then that's a reasonable
9
Now, you said that your kids used the baby
9 supposition.
10 pow der -- you used the baby pow der on your kids?
10
Q Okay, and in the 1960s, Johnson & Johnson was
11
A Yeah.
11 aw are th at doctors w ere alread y saying baby pow der
12
Q They use it on the grandkids; right?
12 shouldn't b e used on babies; right?
13
A Yeah. Still do. O r their parents do.
13
A Y eah, doctors are entitled to an opinion.
14
Q Okay.
14
W e've certainly seen in the last couple o f
15
N ow , m y question, then, is that's, w hat, 12
15 days th at a couple o f doctors, o r certainly several
16 p eo ple? E ig h t grandkids, th ree k i d s ...
16 doctors, h ad that opinion.
17
A It's eleven.
17
Q I'm going to re-ask the question because you're
18
Q Okay, well, including you said your 99 year old
18 answ ering a question I didn't ask.
19 m um ?
19
A Okay.
20
A Yeah, m y mum, yeah. W ell, she passed away and 20
Q Johnson & Johnson knew, as o f the 1960s and
21 w h e n w e w ere clearing o ut h e r cupboards recently 1
21 even before, that doctors w ere recom m ending against the
22 noticed another tub o f Johnson's Baby Powder.
22 use o f baby powder, saying it should not be used;
23
Q Yeah. W hat did you do w ith it?
23 correct?
24
A W ell, like everything else in the house, it
24
A Some doctors were.
25 w ent in the dumpster.
25
Q Johnson & Johnson still sells it; correct?
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1
A Correct.
1 should be minimized; correct?
2
M R PA NATIER: Let's go o ff the record and see
2 A Yes.
3 if I have anything else.
3
MR PANATIER: Those are all the questions I
4
(O ff the record at 6:32 pm)
4 have for you at this time, sir. Thank you.
5
(On the record at 6:34 pm)
5
THE WITNESS: Thank you.
6 BY M R PANATIER:
6
EXAMINATION:
7
Q Just briefly, sir, Exhibit 22 --it was one o f
7 BY MS FROST:
8 the first exhibits w e used in the case, was a report o f
8 Q Dr Hopkins, I'm going to start close to the end
9 a visit to Italy in 1959, and I'll go ahead and hand it
9 o f where Mr Panatier ended.
10 to you. I have a copy o f it.
10
In connection with the ongoing sale of
11
This is just on the last thing we talked
11 Johnson & Johnson Baby Powder, has the company had any
12 about. 1959. H ere's w h at it says:
12 reason historically to be concerned about the
13
"The Val Chisone owners were worried lest we
13 development o f mesothelioma in the users o f its baby
14 had found poisonous m inerals in the talc or had
14 powder or other cosmetic baby products?
15 oth erw ise b e en displeased. W h en to ld w e m erely had a 15 A No, none whatsoever.
16 sch em e fo r im proving th eir ex cellent talc, th ey w ere
16 Q You spoke with Mr Panatier about the Rubino
17 m o st anxious to cooperate. M asci ex p lain ed th at ou r
17 study, and irrespective o f which o f the years of
18 p ro b lem w a s n ot a m atter o f dissatisfaction, b u t th at
18 publication we're talking about, can you tell us
19 a b o u t 1/3 o f the doctors are presen tly ad vising against
19 whether or not the data concerning the development of
20 the use o f baby talc inasmuch as starches and oils have
20 neoplasms was made available to the medical community?
21 a greater purity and there is no dangerous dust to
21 A It was made available, yes, through symposia,
22 inhale".
22 publications, yes.
23
Now, you remember reading that on Day 1 ,1
23 Q The data that is important as it relates to
'
24 think?
24 these specific cases that we're here about, lung cancer
25
A Yes, w e've read this before, yes, yes.
25 or mesothelioma, was that information included in the
Page 1388
Page 1390
1
Q A nd yo u have said repeatedly everyone is
1 published version, or was it excluded from the
2 entitled to their opinion, but this is one third o f
2 published version?
3 doctors, according to them , in 1959; right?
3
A There's a record m entioning m esotheliom a and
4
A That is w hat is written, yes.
4 lung cancer that was included as part o f the analysis.
5
Q Okay.
5
Q A n d is th at tru e w h eth er w e 're talking about
6
H old on, there's one m ore thing apparently
6 1976 or 1979?
7 that I'm supposed to ask about.
7
A Yes.
8
A nd then the very next sentence, sir.
8
Q M r Panatier asked you about a document numbered
9
M r M asci is som eone w ith Johnson & Johnson,
9 265, and I'm going to hand you m y copy o f that.
10 N ick M asci; right?
10
Do you rem em ber that? That is the ENV
11
A Yes, that's m y --m y read o f it, yes.
11 analysis?
12
Q W ell, it actually says he's --
12
A Yes, I do rem em ber this. I recollect reading
13
A Yes, it does. It says Johnson & Johnson, yes.
13 th is som e w hile back.
14
Q T he next thing he says is:
14
Q In connection with the ENV analysis, is there
15
"M asci explained that J& J has no desire to
15 an y thing in the tex t o f th at rep o rt th at h elps us
16 g et into the m ining b u siness ... its objective is to
16 identify the source o f the talc being evaluated?
17 p ro duce a superior po w d er ... to reverse the presen t
17
A N o. It's ju st described as nine talc samples.
18 m ark et tren d w hich is aw ay from talc".
18
Q Can you tell us w hether or not the samples are
19
R ig h t?
19 industrial talc or cosm etic talc?
20
A That's w hat he states, yes.
20
A This report does not identify w hether they're
21
Q Right.
21 industrial or cosm etic, o r even if they are Johnson &
22
A That's w hat's w ritten, yes.
22 Johnson talc.
23
Q Okay.
23
Q In evaluating talc, and w e talked about this
24
And in 1969, the company doctor said that any
24 earlier today w hen w e were talking about M r Bill
25 use o f asbestos - any use o f talc if it had asbestos
25 Ashton, w ould there have been any reason for Johnson &
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Page 1391
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1 Johnson to have an outside source evaluate a talc
1
A I do, yes, yes.
2 sam ple at the time period o f this report in 1977 that
2
Q W ould you look on the page where they have the
3 w a s n ot rela te d to a specific m in e from w hich Johnson & 3 su m m ary o f the m ineralogic com position o f the 18
4 Johnson w as sourcing its cosm etic talc?
4 B ritish consum er talcum products, and I'm going to hand
5
A W hat actually happened, and I rem em ber Bill
5 y o u m y copy o f th at so y o u do n 't have to look for
6 A shton w hen I m et w ith him m any tim es, is that over the 6 yours.
7 years he received talc samples from prospective m ines
7
Do you see that?
8 all over the w o rld from Asia, India, China, Latin
8
A Yes, I do, yeah.
9 Am erica, several in Europe, who were saying: please
9
Q Can you tell us whether or not the indicated
10 evaluate o u r talc; can w e o ffer y o u as o u r talc as an
10 m ineral references say fo r the am phiboles w hether those
11 alternative to w h a t yo u 're doing.
11 are asbestos o r n o t asbestos?
12
So in fact his shelf in his little cubicle
12
A N ow here does it actually state they are
13 h a d lots an d lo ts o f differen t sam ples o f talc th at had
13 asbestos. T h ere's a description o f trem olite, b u t it
14 b e en sent in, to tally unsolicited, b y p ro spective m ine
14 doesn't state w hether it's asbestos trem olite or not.
15 ow ners in m an y p a rts o f the w orld.
15
A nd likew ise for anthophyllite. It doesn't
16
So it w as typical that he w ould say: yeah,
16 state w hether o r not it's asbestos trem olite.
17 let's look at it. It do esn 't co st a great deal. L et's
17
Q It is very late in the day. Can you tell us
18 ju s t see w h a t the q u ality o f this talc is.
18 d o es the use o f the w o rd "trem olite" o r "anthophyllite"
19
So he w ould invariably send o ff -- if it
19 alone answ er the question for u s o f w hether or not that
20 looked w hite, then he w ould say: yeah, let's check it
20 is asbestos?
21 out, it could be o f use to us.
21
A It does not, no.
22
And they were just labeled w ith a number, A,
22
The m ajority o f trem olite that we find in the
23 B, C, 1 ,2 ,3 .
23 w orld, the vast m ajority is not asbestos tremolite.
24
B ut that's all w e have. It's all I've seen
24
Q In connection w ith that report, and you m ay set
25 at this point. It w as unknow n talc samples.
25 that down, sir, M r Panatier also asked you about a memo
Page 1392
Page 1394
1
Q Now, in fairness, that particular report does
1 from D r Langer to D r Chalm ers that purports to explain
2 use the w ord "composite" as it relates at least to some
2 w hat was done in connection w ith that paper.
3 portion o f m aterials that were being evaluated.
3
D o you rem em ber those questions?
4
A Mmmhmm.
4
A Id o,yes,yes.
5
Q Does the use o f the term "composite" help you
5
Q A nd it makes reference to pressure put on D r
6 in any way to reach a conclusion about the source or
6 Pooley.
7 identity o f the materials that are being tested?
7
D o you recall those questions?
8
A N ot really. Y ou could have a composite sample
8
A Yes, I do, yes.
9 from more than one supplier.
9
Q O ther than D r Langer's m em o that talks about
10
For exam ple, if you've got tw o m anufacturers,
10 the w ithdraw al o f the paper, have you seen anything
11 tw o m ine ow n ers in a particu lar area, th ey co uld w ell
11 fro m D r P oo ley th at says th at D r P oo ley agrees or
12 sen d y o u a com posite from w h a t th ey h a d from their
12 disagrees w ith the representation by D r L anger
13 m ine.
13 concerning the handling o f the p aper a t the sem inar?
14
It's -- the problem w ith this report is it is
14
A N o, I've not seen any com m ent from D r Pooley.
15 n o t specific. It do esn 't give y o u th at lev el o f
15
Q Are you familiar with this particular issue,
16 inform ation that would, in m y view , give you an
16 and w ere you fam iliar at the tim e w ith the discussion
17 assurance th at yo u w ere lo o k in g a t a Jo h nson's cosm etic 17 ab o u t the presen tatio n o f the p ap er a n d the ultim ate
18 talc. It's n o t m en tio n ed anyw here.
18 w ithdraw al o f it by D rs Pooley and Langer?
19
Q M r Panatier also asked you about a document
19
A A t the time, I was not em ployed by Johnson &
20 num ber 266 w hich reflects to b e a draft -- it's poor
20 Johnson, but obviously I have since read part o f that
21 quality, but it says "Subject to being revision [sic]
21 100-odd thousand docum ents that there w as a dialogue
22 not to be quoted", and this is the document that was
22 betw een D r Pooley, or Professor Pooley and D r Langer
23 labeled as a draft article by both Drs Pooley and Dr
23 related to the w ithdraw al o f that paper.
24 Langer.
24
Q A nd based on your review o f those documents,
25
Do you rem em ber talking about that?
25 w hat is your understanding o f the reason why the paper
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1 was withdrawn?
Page 1395 1
Page 1397 Q M r Panatier also asked you som e questions,
2
A M y understanding, having read that, is that
2 looking back at som e 1995 findings by M cCrone regarding
3 Professor Pooley wasn't happy w ith the w ay the paper
3 asbestos in some o f the talc.
4 was written and the conclusions that were being drawn
4
Do you recall those questions?
5 from it. H e did not w ant to be associated w ith it.
5
A I do, yes.
6
Q M r Panatier asked you some questions about
7 testing and the frequency o f testing and the ability to
6
(Reporter clarification)
7
Q I am going to hand back to you Exhibit num ber
8 test every piece o f talc that cam e out o f the mine.
8 234.
9
Do you rem em ber those questions?
9
Separate and apart from what M r Panatier has
10
A Yes, I do, yes.
10 on the flip-chart, w hat did M cC rone tell to a third
11
Q Can you tell us w hether or not it is an
11 p a rty in 1987 ab o u t its historical findings related to
12 app ropriate statistical m eth o d to do sam pling o f
12 asbestos in the talc th a t w as being m ined from W indsor
13 p ro d u ct -- w h e th er w e're talk in g a b o u t talc or
13 a n d u se d b y Johnson & Johnson?
14 som ething else -- in o rd er to determ ine the quality o f
14
A Yes, they looked at all their analyses o f
15 th at product?
15 asbestos ov er the p erio d 1971 onw ards to 1984, and th ey
16
A W ell, the point o f achieving w hat you're trying
16 sum m arized that by saying that:
17 to fin d is statistical relevance o r significance.
17
"Throughout this entire period I can only
18
Essentially, as w ith anything, the m ore tim es
18 recall tw o o c c a sio n s... [in] w hich som e suspicious
19 y o u test, y o u test a n d test and te s t again, th en the
19 m aterial w as detected. T he first involved possible
20 higher level o f surety you have to be able to say: this
20 chrysotile contam ination in an air sample and the
21 product is free from asbestos.
21 contam ination source w a s ... pin p o in ted to a
22
If you test once, you've got an assurance
22 deteriorating clutch in som e m echanical equipment".
23 level o f one. I f you test a hundred tim es, then you're
23
A nd the second was a novel one that was
24 a hundred tim es m ore assured o f the result that you've
24 w ritten up in the m edical literature --in the
25 got.
25 scientific literature, w hich w as indicated that there
Page 1396
Page 1398
1
Q In connection w ith the sam pling that was done
1 w as no asbestos present.
2 by Johnson & Johnson to test its ore and the m aterial
2
Q A nd the sort o f bottom line sum m ary from
3 from the m ine, was the frequency sufficient from a
3 M cC rone concerning its conclusions about the ore it had
4 statistical standpoint to provide any level o f
4 been testing throughout that entire tim e period was
5 certainty regarding the quality o f the talc?
5 what?
6
A I w ould say yes a n d --
6
A "... our opinion [has alw ays been that] and
7
Q Why?
7 continues to be ... [that in] 15 y ears o f closely
8
A - w ith the caveat that, over tim e, if you test
8 e x a m in in g ... pro d u ct [the pro d u ct is free from
9 once, you've got an assurance o f one. B ut you do that
9 asbestos]".
10 regularly over the year m any tim es and do it again the
10
Q D id Johnson & Johnson have any basis to
11 n ex t y e ar an d the n e x t year, a n d i f you 're finding
11 co nclude th at the level o f exposure to talc associated
12 resu lts th at m eet the requirem ents, th en y o u r level o f
12 w ith its cosm etic products w ere not associated w ith the
13 su rety is very, v e ry high.
13 risk o f d ev elopm ent o f m eso?
14
Q W hat w as the level o f surety o f Johnson &
14
A There is no evidence that talc products sold by
15 Jo h n so n in co nnection w ith the talc th at it w as
15 Jo h n so n & Johnson w ere associated w ith m esotheliom a.
16 receiving for use in its baby pow der and cosm etic
16 None.
17 p o w d er products?
17
Q Prior to the litigation that w e're here about,
18
A W ell, the level o f surety com es from
18 and som e other contem poraneous litigation, over the
19 u n d erstan d in g o f the m ine an d the m ine geology. So yo u 19 co urse o f tim e from 1894 to close to contem porary
20 start at that point w ith a historical record o f absence
20 times, has Johnson & Johnson had any experience
21 o f asbestos from the m ine sam ples.
21 concerning m esotheliom a and its products?
22
And then the regular quarterly audit o f the
22
A No, they have not.
23 m ine as you progress. You look at that data, add that
23
Q A t the end o f the day, have any o f the
24 to your pile, and then you add to the data pile by
24 questions M r Panatier has asked you changed your
25 taking results from every tw o-weekly samples.
25 opinion regarding the safety or purity o f Johnson &
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Page 1399
1 Jo h nson's p ro d u cts?
2
A N o. I'd go hom e and use Johnson's Baby Pow der
Page 1401
1
Q Right? That has some cancer data from that
2 paper; correct?
3 tonight. I've no --no concerns.
3
A Yes. The '76 publication, it does - it does
4
M S FRO ST: I don't have any further questions
4 talk about m alignant neoplasms o f the esophagus,
5 for you, sir. I w ill pass you to the next one.
5 pleura, mesotheliom a. It m easures those: lung, larynx,
6
M R G A FFR EY : I don't have any further
7 questions.
6 stom ach, intestine.
7
It does m ention mesothelioma.
8
EXAM INATION:
8
Q Keep it on that page; okay?
9 BY M R PANATIER:
9
A Okay.
10
Q Ido.
10
Q That's in 1976. That's one paper?
11
All right, sir. Sir, you said that Johnson &
11
A Yes.
12 Jo h nson has no concern reg ard in g m esotheliom a for the 12
Q That's the m ortality paper; correct?
13 u sers o f its pow ders; right?
13
A Yes.
14
A That's m y opinion, yes.
14
Q Then there's a second paper four years later;
15
Q Johnson & Johnson has never surveyed its users
15 right? T he m orbidity paper; correct?
16 to see the disease incidence am o n g them ; correct?
16
A Can w e look at that?
17
A That w ould be correct, yes.
17
Q Y ou're looking at it right there. That's the
18
Q Johnson & Johnson -- certainly an indication o f
18 p rep ublication version.
19 w h eth er o r n o t Jo hnson's talcs can cause m eso w o u ld be 19
Actually, it m ight be easier to get the -
20 individuals w ho get m esotheliom a from using it and then 20 let's hop o ff the record.
21 su e Johnson & Johnson; correct?
21
(O ff the record at 6:55 pm )
22
That w ould be an indication, w ouldn't it?
22
(On the record at 6:55 pm )
23
A That would be an indication o f a dialogue or a
23 BY M R PANATIER:
24 discussion about the relationship.
24
Q Y ou have in your hands the second Rubino paper;
25
Q Okay.
25 right?
Page 1400
Page 1402
1
Now, you mentioned, you painted it in a very
1
A Yes.
2 broad brash stroke, and said all o f Rubino's data w as
2
Q Okay.
3 available to the m edical comm unity.
3
A B u t this w as never published.
4
Do you recall that?
4
Q It w as published.
5
A The data was available in various publications,
5
A W here w as it published?
6 yes.
6
Q In the Society o f O ccupational and
7
Q W e know that's not true; right? W e know the
7 E nvironm ental H ealth Journal.
8 second publication has five categories o f increased
8
A Y es, this w as the -- I have -- I do recollect
9 cancer that never saw the light o f day; correct?
9 this.
10
A I believe it w as in the Rubino paper, was it
10
Q Okay.
11 not?
11
A T his w as presented as a paper at a sym posium
12
Q It was in the prepublication version o f the
12
Q Okay.
13 seco n d p ap er. T h e se co n d p ap er only re p o rte d o n lu n g
13
A Y es, it w as one o f several papers presented.
14 cancer; correct?
14
Q A n d rig h t u n d er it, okay, y o u hav e -- g et rid
15
A I'd need to look at that again.
15 o f that, th at is the o th er - y o u set this to the side.
16
Q Okay. I'm perfectly happy for you to do that.
16
A Yeah. Thank you.
17
A Okay.
17
Q H ere y o u go. T h at's th e p rep u b licatio n versio i
18
Q H ere's the prepublication version.
18 o f the docum ent there on yo u r left; correct?
19
A Yeah.
19
A It is a prepublication version o f a paper
20
Q H ere's the first version that's not
20 entitled M ortality and M orbidity in T alc M iners and
21 prepublication for that; right?
21 M illers in Italy, w h ich is the sam e title, yes.
22
A Okay.
22
Q T h at's right.
23
Q The paper you're looking at right now in front
24 o f you w as published in '76.
23
So you have the published version in your
24 right hand -- in your left hand, and you have the
25
A Yes.
25 prepublished version in your left hand; correct?
87 (Pages 1399 - 1402)
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Page 1403
1
A W e have a version -- a prepublication copy o f a
2 paper.
Page 1405
1
So I can see w hy that m ay have dropped out,
2 certain im portant --you m ay consider them important --
3
Q Right.
3 im portant areas o f discussion and debate.
4
W e already established that all o f the data
4
But in the publication that preceded this,
5 about the excess cancers do not appear in the published
5 the '76 paper --the '74 paper --he does look at
6 version; correct?
6 neoplasm s across the board, including mesothelioma.
7
A In the version that was presented as a lecture?
7
Q I'm going to ask you the question again.
8
Q Yes.
8
Sir, for the m orbidity paper that was either
9
A The 15-minute lecture in the Society.
9 presented or published --
10
Yes, this was --this was --that was the
10
A Yes.
11 d ata th at w as presented.
11
Q --I'll give y o u w h ich ev er one yo u w ant; okay?
12
Q H old on a m inute. I'm going to hold this up
12
A Okay.
13 fo r th e cam era.
13
Q D id it contain the five categories o f increased
14
This is a 15-minute lecture?
14 cancer that w as in the prepublication version? Y es or
15
A W ell, or h alf an hour lecture.
15 no?
16
Q Hold on. Hold on. Hold on.
16
A N o, it w as a sim plified version. It did not.
17
This w as a --w hat w as it? A 15-minute
17
Q It did not?
18 lecture? A h alf-h o u r lecture? W h at w as it?
18
A Correct.
19
A It was given as a lecture to a professional
19
Q They didn't suggest that there w as any
20 society.
20 increased cancer in the paper that was either presented
21
Q Okay.
21 o r published; correct?
22
A In --I believe it was Edinburgh.
22
A Correct.
23
Q A nd w hen it w as given, sir, did it contain all
23
Q Okay. Y ou can set that aside.
24 o f the cancer data for the increased cancers o f the
24
Y ou said the ENV paper, w hich you have there,
25 five categories that the prepublication version
25 right, w hich I w rote on the board all o f the fibrous
Page 1404
Page 1406
1 contains?
1 trem olite that was found there in 1977, you said that
2
A No, it did not.
2 c o u ld b e A shton w anting to test som ebody else's talc;
3
Q Okay. Y ou can set that aside, please, sir.
3 right?
4
A Yes.
4
A Yeah, I don't know w hose talc this is. This
5
Q Are you aware o f a published version o f the
5 doesn't describe w hose talc this is, w hich m ine it's
6 second Rubino paper that does include the increased
6 from.
7 incidence o f the five cancer categories?
7
It basically doesn't have enough data to be
8
A The paper that follow ed the first Rubino paper
8 able to say: yeah, I feel confident in saying this is
9 w as by R ubino's colleagues, D r Coggiola, in 2003.
9 yes or no Johnson's Baby.
10
That was an update o f the data that was
10
Q W ell -
11 available.
11
A There's no evidence here.
12
Q So you're saying that if w e w ant the data that
12
Q I f it's y o u r o w n talc, y o u d o n 't have to label
13 w a s w ritten th ere in --o f five in creased categories o f
13 it th at it's yo u r ow n talc, do you?
14 cancer from 1979, w e have to go to 2003?
14
A W hen you send a sam ple o ff to -
15
A W ell, all w e've got is w hat w e've got.
15
Q Can you ju st have to answer the question?
16
W e'v e g o t tw o papers, o r th ree pap ers, a n d w e
16
A No.
17 h av e a prep u b licatio n version o f a paper.
17
Q I f it's y o u r ow n talc, y o u d o n't have to list
18
Now, I --you know, I cannot be specific as
18 th a t it's y o u r ow n talc; right?
19 to w hy certain lines w ere rem oved from the half-hour,
19
A Y o u do n 't. Y o u d o n't have to, b u t y o u don't
20 one-hour lecture. They obviously were.
20 need to do so either. It's a choice.
21
Certainly, you know, I've given sym posia
21
Q Okay. All right.
22 talks and very often you're going to give it to a group
22
N ext question. So you --w e were talking
23 who have got expertise or experience in different
23 about the unpublished Pooley paper. Before you can
24 areas. It's not unusual to focus dow n on the m ain
24 have trem olite asbestos, you have to have trem olite the
25 bullet points.
25 m ineral; right?
88 (Pages 1403 - 1406)
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1
A Correct.
Page 1407
Page 1409 1 asbestos, in fact twice as m uch in the cosmetic as they
2
Q And before you can have anthophyllite asbestos,
2 did in the industrial?
3 you have to have anthophyllite the m ineral; right?
3
A T hey did not.
4
A Yes.
4
Q Did they m ention this one? Now, this one was
5
Q So by having the m ineral, you're h a lf w ay
5 industrial, but did they m ention that they found
6 there, but you've got to get fibers; right?
6 chrysotile fibers at .006 per cent in an industrial
7
A Correct.
7 sample?
8
Q Okay.
8
A M y understanding is they are only discussing
9
You said your recollection o f the reason why
9 cosm etic grade talc.
10 the Pooley paper w as w ithdraw n w as because Pooley
10
Q To Arm strong W orld Industries?
11 w a sn 't satisfied w ith h o w th e p a p er w a s b ein g w ritten?
11
A Y eah. I m ean, this doesn't m ake it clear
12
A Yes.
12 w hether it's asbestos in cosm etic or industrial.
13
Q H e w as the lead author; right?
13
Q So M cCrone doesn't m ention this one either;
14
A He was on a draft, yes, but not --the paper
14 right?
15 n e v er got to the stage o f b ein g ag reed to a fo rm at that
15
A No.
16 c o u ld b e published.
16
Q Okay.
17
Q The only copy w e have, he's the lead author;
17
Let's see here. I don't rem em ber all the
18 rig ht?
18 ones th a t M cC rone.
19
A H e's the lead author --
19
This one is. 4.24.74, the evaluation o f
20
Q Okay.
20 A rgonaut w here they found chrysotile. They didn't
21
A - and that was in the form as a presentation
21 m ention that, did they?
22 to a symposium.
22
A They did not.
23
Q And, lastly, M s Frost asked you to reread the
23
Q They didn't m ention the S5888 sam ple that was
24 letter from M cCrone w here they said from 1971 to 1984 24 chrysotile, did they?
25 they only had tw o occasions w here there w as asbestos in 25
A T hey did not.
Page 1408
Page 1410
1 talc.
1
Q L et's see here ...
2
One was they discovered that there was a
2
T h ey d id n 't m en tio n finding trem olite in 108
3 clutch that w as disintegrating in the m achine; right?
3 and 109T in O ctober o f '72, did they?
4
A Yes.
4
A No, but it could well have been non-asbestos
5
Q A nd another one, they ju st said was w ritten up
5 tremolite.
6 som ewhere, b ut they don't say w hat it was; right?
6
Q I hear w hat you're saying.
7
A They don't, no.
7
T hey didn't talk about finding chrysotile in
8
Q So really that means really no occasions o f
8 the additive to m edicated pow der in Septem ber o f '71;
9 asbestos in talc; right?
9 right?
10
A It does, yes.
10
A N ot in this, because there is a separate note
11
Q Okay.
11 I've seen th a t chrysotile c o u ld b e co n fu sed w ith the
12
So let's go to --so the ones I've w ritten
12 free flow agent, sodium sesqui citrate, that w as added
13 d o w n here, 1975, N o v em b er 5 ,1 9 7 5 , th at w a s M cC rone; 13 to h elp th e talc n o t stick in th e bottle.
14 correct?
14
Q Y ou said that, too.
15
A Correct.
15
The bottom line is M cC rone did not convey all
16
Q That's an occasion o f fibers o f asbestos they
16 o f the tim es they had found asbestos, even in cosm etic
17 found; right?
17 talc, in that letter; correct?
18
A That's w hat you've w ritten, yes.
18
A That letter states that they did not find
19
Q D id they put that in the letter?
19 asbestos in cosm etic talc over a 15 y ear period.
20
A That's w hat is written.
20
Q In their ow n words, they did; correct?
21
Q Did they put that in the letter w here they said
21
A But the letter states that they did not.
22 they'd only had those tw o occasions; right?
22
Q B ut in their own words --these are their
23
A In their overall sum m ary o ver 15 years, they
23 words, because I w anted to m ake sure that I did this
24 did not m ention that.
24 straightforward; okay?
25
Q Did they m ention this one where they confirm ed
25
In their ow n w ords, they did find asbestos in
89 (Pages 1407 -1410)
Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
Page 1411
Page 1413
1 talc?
1 w hether or not w e could tell if these were cosmetic or
2
A On the - the w ay you've written it on those
2 not.
3 boards, they claim - yes, that is what is written.
3
HC: cosm etic; correct?
4
Q Those quotes, right, remember you and I?
4
A W ithout seeing the tabulation to confirm that,
5
A Yeah, you've written that, yes.
5 it's a guestim ate.
6
Q Those were their words; right?
6
Q You and I talked about this. W e saw the
7
A Yes, that's your ~ that's the words you've
7 designations that W indsor M ineral used. HC was
8 written, yes.
8 cosmetic. W indsor w as W indsor Industrial and G was
9
Q That they wrote for me to write?
9 Gassetts.
10
A That's w hat --that's w hat you've written, yes. 10
D o you rem em ber that?
11
M R PANATIER: Pass the witness.
11
A I do rem em ber that, yes.
12
EX A M IN A TIO N :
12
Q They said this w as the cosmetic; correct? HC?
13 B Y M S FRO ST:
13
A I'll take your w ord for it, but I cannot
14
Q One last question: in connection with the
14 rem em ber w hether that is a definition for the cosm etic
15 letter from M cC rone in 1987, it is specific ab o u t the 15 grade.
16 W indsor m ine, is it not?
16
M R PANATIER: N o furthers questions.
17
A It is, yes.
17
Anybody on the phone?
18
Q A nd it is specific about cosm etic talc, or is 18
(O ff the record at 7:07 pm)
19 it?
19
(O n the record at 7:08 pm )
20
A It doesn't m ention cosm etic talc. A t least if 20
M S FROST: To the extent that they are J& J
21 it does, I can't see it.
21 B ates stam ped docum ents that w e produced to you, sam e
22
Q Okay.
22 stipulations as yesterday.
23
But talc from the W indsor mine would have 23
A s it relates to the reading o f the
24 been Grade 66?
24 transcript, the w itness w ill w ant to read the
25
A Yes, it would, yes.
25 transcript.
Page 1412
Page 1414
1
Q So that w ould be cosm etic talc?
1
M R PANATIER: C an we stipulate to an unread
2
A Yes, it would, yes.
2 and signed version to be used in motion practice if
3
Q A nd M r Panatier just asked you about a whole
3 necessary?
4 series o f various reports.
4
M S KAGAN: W e did that with the rough.
5
O f those reports - those previous reports,
5
M R PA N A TIER: W e're already doing it w ith the
6 can w e tell w hether or not those evaluations were from
6 rough, but I figured ~
7 the W indsor m ine, from one o f the other m ines in
7
M S FROST: W e can make that agreement.
8 Verm ont, or not?
8
M R PANATIER: Yeah. Okay.
9
A W e cannot.
9
(W hereupon the deposition concluded at 7:09 pm)
10
Q Can w e tell from those results whether the
10
11 fin dings th ey are reco rd in g are o f cosm etic talc o r o f
11
12 in d ustrial talc?
12
13
A W e cannot. That's not specified in the
13
14 reports.
14
15
I f it states G rade 66, it's cosm etic talc.
15
16
Q In connection w ith the findings that relate to
16
17 trem olite, can w e n ecessarily tell w h eth er those are
17
18 asb estos o r non-asbestos?
18
19
A That's not defined. It could be asbestos.
19
20 M ore likely non-asbestos.
20
21
M S FRO ST: I don't have any further
21
22 questions.
22
23
EXAM INATION:
23
24 BY M R PANATIER:
24
25
Q Let's ju st m ake sure: M s Frost ju st asked you
25
90 (Pages 1411 -1414)
Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
Page 1415
1
INDEX
1
2
Page
2
3 W ITNESS: D R JO H N HO PKINS (Recalled)
106< 3
4 Exam ination by M S FROST
1066
4
5 Exam ination by M R GAFFREY
1242
5
6 Exam ination by M R PANATIER
1250
6
7 Exam ination by M S FROST
1389
7
8 Exam ination by M R PANATIER
1399
8
9 Exam ination by M S FROST
1411
9
10 E xam ination b y M R PA N A T IE R
1412
10
11
11
12
EXHIBITS
12
13
13
14 E xhibit D escription
Page
14
15 N o.
15
16 220 L etter H ills (W M I) to P alen ik
16
17
(M cCrone)
17
18
JNJ000065646
1101
18
19 221 L ist o f Sam ples to M cC ro n e from
19
20
Hills (W M I)
20
21
JNJ000065647
1101
21
22 222 Im ages o f talc - "D -507"
22
23
N o Bates
1114
23
24
24
25
25
Page 1417
Exhibit Description
Page
No.
230 W ebsite from FDA Re Talc
No Bates
1150
231 Letter N ashed (J&J) to Schaffner
(FDA) Re Johnson's Baby Powder
JNJMX68 5215
1154
232 Letter Pooley to Shelly (J&J)
Re examination o f Italian
JNJAZ55 3645
1157
233 Pooley Report o f the Examination
O f Rock Samples from the Vermont
M ine
JNJMX68 14190
1161
234 Letter Stewart (M cCrone) to Benninger
(Armstrong) cc M iller (W indsor) and
M illette (M cCrone) Re W indsor Minerals
Inc
JNJMX68 00001... ?
1163
235 J& J M aterial Analysis Report W indsor
66 Talc
JNJM X68_000016...?
1169
236 J&J W orldwide 1975 Talc Monitoring
Program
JNJNL61 32876
1172
Page 1416
Page 1418
1 Exhibit D escription
Page
1 Exhibit D escription
Page
2 No.
2 No.
3 223 W ebsite Select C om m ittee on G RA S 3 237 M em o o f M eeting betw een FR A and
4
S u b sta n c e s
4
C T FA and J& J R e A sbestos in Cosm etic^
5
N o Bates
1118
5
C ontaining Talc, Such as D usting
6 224 J& J R aw M aterial Specification for
6
Pow ders and Face Pow ders
7
Talc Pow dered
7
N o Bates
8
JN J000370144
1121
8
A ppears to be FO IA
1174
9 225 Three T ypes o f C om m ercial A sbestos 9 238 L etter to E ditor from Lew in
10
Im ages.
11
N o B ates
1124
12 2 2 6 L e tte r L e e (J & J ) to F ra n k (J& J)
10
R e J& J Finding
11
JNJM X68_4614
1178
12 239 L ew in R eport (m issing cover page)
13
R e W indsor 66 Talc Specification
13
N o Bates
1180
14
- Proposed A sbestos R equirem ent
14 240 Sum m ary and C om m ents on A nalysis
15
JN J000252240
1133
15
F or A sbestos in C osm etic Talc
16 227 T ools for S tate-of-the-A rt
16
Products by Eierm ann (FDA)
17
Testing 1974-1995 im ages o f
17
JN JNL61_18340
1183
18
Testing equipm ent
18 241
"D octor A dm its H e M ay H ave
19
N o Bates
1138
20 2 2 8 W e b s ite U S P - A b o u t U S P
21
N o Bates
1146
22 2 2 9 R e v is io n B u lle tin T a lc U S P
19
B een M istaken"
20
JN J000343318
1186
21 242 N Y T im es "A sbestos F ound in
22
T en Pow ders"
23
M ethod
23
N o Bates
1188
24
N o Bates
1148
24
25
25
91 (Pages 1415 -1 4 1 8 )
Priority-One Court Reporting Services Inc. A V e r ite x t C o m p a n y 718-983-1234
1 Exhibit D escription 2 No.
Page 1419 Page
1 Exhibit Description
2 No.
Page 1421 Page
3 243 E ierm ann and Y ates Tabulated
3 253 CTFA Memo Re NTP
4
R esults o f D C S T 's A nalyses for
4
Pltf_IM ERY S_00041221
5
A sbestos M inerals in Lew in
5
IMERYS-A 0012865
1259
6
Field A ctivity Surveillance
6 254 Email from Zezinski Re NTP
7
N o Bates
1189
7
"Fine Victory" "Dodged Bullet"
8 244 M em o o f M eeting at M t. Sinai btw n
8
Pltf_IM ERYS_00077020
9
L anger and FD A R e 10 Sam ples
9
IMERYS 303828
1262
10
HHS00000018
11 2 4 5 . D o u ille t L e tte r re s p o n s e to
12
C itizens Petition R e A sbestos
1191
10 255 L etter from D esert M inerals (JM )
11
To Ashton Re FDA Talc Regulation
12
For Food;
13
W arning
13
Letter from Colorado School Mines
14
N o Bates
14
To JM
15
FO IA
1193
15
JN JN L 61J6536;
16 246 W ergeland, et al. "C ause-specific
16
JNJAZ55 6145
1272
17
M ortality and C ancer M orbidity in
17 256 M em o o f M eeting btw n CTFA (Estrin)
18
390 M ale W orkers E xposed to H igh
18
W ith FDA Re Lewin
19
P urity T alc, a six-decade follow -up"
19
HHS 65
1287
20
N o Bates
1235
21 247 W ergeland, et al. "M orbidity and
20 257 1973 L ew in W IT H W E ISSL ER C O V ER
21
LETTER
22
M ortality in Talc-Exposed W orkers"
22
N o Bates
1290
23
N o Bates
1236
23
24
24
25
25
Page 1420
Page 1422
1 Exhibit Description
Page
1 Exhibit D escription
Page
2 No.
2 No.
3 248 Leodolter, et al. "A Cohort M ortality
3 258 Q uality A ssurance Testing o f W indsor
4
And Nested Case-control Study o f French
4
66 T alc and Johnson's B aby P ow der
5
And Austrian Talc Workers"
5
Form ula 499
6
N o B ates
1234
6
JNJM X68_3587
1293
7 249 Coggiola, et al. "An Update o f a
7 259 J& J M em o "The M t Sinai Sam ples Are
8
M ortality Study o f T alc M iners and
8
O ld"
9
M illers in Italy"
9
JNJM X68 9855
1297
10
No Bates
1228
10 260 J& J M em o "Telephone C onversation
11 250 Piro, et al. "M ortality o f Talc
11
W ith F.D . Pooley"
12
M iners and M illers from V al Chisone
12
JNJM X68_17760
1299
13
N orthern Italy"
13 261 S tim uli to R e v isio n P rocess for
14
N o Bates
1230
14
USP
15 251 Selevan, D em ent, et al. "M ortality
15
N o Bates
1312
16
Patterns Among Miners and M illers o f
16 262 M cC rone to C yprus re C W M 90-28,
17
Non-Asbestosform Tale: Preliminary
17
9 0 -2 9 ,9 0 -3 0
18
Report"
18
JNJM X68_12851
1329
19
No Bates
1232
19 263 H TR I R esearch Institute to F D A
20 252 Letter Ferry to Smith (W CD)
20
JN JN L 61_20261
1341
21
Re Italian to J&J
21 264 A sbestos O ccurrence in Talc Control
22
CF-B ALL-5
1250
22
W orldw ide
23
(Produced by W CD in Kaenzig)
23
JNJNL61 16002
1345
24
24 265 EM V R eport to J& J
25
25
JN JM X 68 8981
1347
92 (Pages 1419 - 1422)
Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
1 Exhibit D escription
Page 1423 Page
1 Exhibit Description
Page 1425 Page
2 No.
2 No.
3 266 P ooley, R ohl, L anger, et al. paper
3 44 Report from Grieger (McCrone)
4
"M ineralogy and C hem istry o f B ritish
4
"from R. Rollo's files"
5
Talc and C onsum er Talcum Products"
5
Re Italian, Medicated
6
JNJAZ55 4614
1356
6
Grantham Talc
7 267 L etter from L anger to Chalm ers R e
7
Bates JNJAZ55 8893
1084
8
T he O ngoing T alc Study in the
8 55 M emo enclosing Pooley Report
9
Environm ental Sciences L aboratory
9
"An Examination o f Italian M ine
10
N o Bates
1361
10
Samples and Relevant Powders"
11
A rchives M ount Sinai
11
Bates JNJAZ55 212
12 268 L etter from J& J to consum er
12
Bates JNJAZ55 87
1086
13
Sorensen bcc W agner and Sem ple
13 56 M em o to File from N ashed
14
R esponding to C oncern R e A sbestos
14
Re Shower to Shower/Asbestos
15
In Johnson's B aby Pow der
15
FDA M eeting, Sept 21, 1972
16
JN JA Z 55_13489
1365 16
Bates JNJAZ55 380
1090
17 2 6 9 E m a il fro m L e m m o (J & J ) R e G lo b a l 17 63 L etter from Frank (J& J) to Lee
18
Talc Specification: Lim its o f Q uartz
18
(J&J) Re Audit Testing o f W indsor
19
(free crystalline silica)/PC PC
19
66 Talc for Asbestos
20
M eeting in D C
20
Bates JN JM X 6 8 J 8545
1094
21
JNJNL61 103603
1 3 7 4 21 69 C onfidential N ew R eagent System s
22 270 Plaintiffs additional pages o f
22
Plant Trial at W indsor M inerals Inc
23
F lip -c h a rt
23
Bates JNJMX68 4996; 5032; 5037
1095
24
N o Bates
24
25
25
Page 1424
Page 1426
1 Exhibit Description
Page
1 Exhibit D escription
Page
2 No.
2 No.
3 271 D efendant flip-chart
3 81 R ep o rt G rieger (M cC rone) to
4
4
M iller (W M I) re H am m ondsville
5
5
T alc
6
PREVIOUSLY M ARKED EXHIBITS
6
Bates JN JM X 68 19934
1097
7
7 83 M em o by R ussell (J& J) Procedure
8 Exhibit Description
Page
8
For Identification and
9 No.
9
Q uantification o f A m phibole
10 17 L etter from Byers (U S P ublic
10
Particles in J& J T alcs U sing
11
Health Service) to Ashe (State
11
O ptical M ineralogical M icroscopy
12
O f VT Dept Public Health)
12
Bates JN JN L61_492
1098
13
Re mineral samples in VT
13 84 R e p o rt M ille tte (M cC ro n e ) to
14
Bates JNJMX68 17827
1075
14
L aPierre (W M I) R e A nalysis o f
15 22 L etter from Sm ith (J& J) to
15
Seven Talc Sam ples for A sbestos
16
Tangel Re Rome, Italy
16
M ineral C ontent by TEM
17
M arch 5,1959 trip
17
Bates JN JM X 68 13019
110C
18
Bates JNJAZ55 1114
1077
18 85 L etter from S chm idt (J& J) to
19 36 C olorado School o f M ines
19
M olnar to M iller R e W indsor
20
Research Institute Report
20
M inerals R aw Talc Subm issions
21
Geology and Ore Reserves
21
N ovem ber 1986 to January 1987
22
Bates JNJAZ55 15127
1080
22
Bates JN JA Z55 8 177
1105
23 41 L etter from N ashed (J& J) to
23
24
Foster Re Talc/Asbestos
24
25
Bates JNJMX68_4646
1082
25
93 (Pages 1423 - 1426)
Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
Page 1427
1 Exhibit Description
2 No.
Page
3 155 M em o Zeitz to M iller of W indsor
4
M inerals re codes for industrial vs
5
Cosmetic VT
6
JNJMX68 2659
1106
7 162 J4-1
8
JNJNL61_53222
1140
Page 1429
1
CERTIFICATE OF DEPONENT
2
3 I, JO H N HO PK IN S, hereby certify that I have read the
foregoing pages, num bered 1 through 356, o f m y
4 deposition o f testim ony taken in these proceedings on
Friday, A ugust 18, 2018, and, w ith the exception o f
5 the changes listed on the next page and/or
corrections, if any, find them to be a true and
6 accurate transcription thereof.
9 188 M em o Caneer (Colorado School o f Mines) 7
10
To Ashton (J&J) Re M eeting with
8
11
Bowling Green Geological Staff
12
JNJAZ55_1871
1199
13 189 C onfidential Talc - U K W ork Status
14
1.6.73, IW Sloan
9
10 11 Signed: ............................ 12 N am e: JO H N H O P K IN S
13 D ate: ............................
15
JNJAZ55_5084
1204
14
16 192 M em o H ildick-Sm ith (J& J) to
15
17
Petterson (J&J) Re Epidemiological
16
18
Study o f Italian Talc M ine
17
19
JN JAZ55J583
1214
18
20 193 M em o H ildick-Sm ith (J& J) to
19
21
Petterson (J&J) Re Epidemiological
20
21
22
Study o f the Cause o f D eath in
22
23
Italian Talc M iners
23
24
JNJAZ55 1607
1216
24
25
25
Page 1428
Page 1430
1 Exhibit D escription
2 No.
Page
1
2
CERTIFICATE OF COURT REPORTER
3 197 M em o A shton (J& J) to H ildick-
3 I, D EIR D R A JO RD A N , an A ccredited C ourt Reporter,
4
Sm ith (J& J) R e Italian Talc
4 hereby certify that the testim ony o f the witness, JOHN
5
Studies V isit to P ro f R ubino
6
U niversity o f Turin, Italy
5 HOPKINS, in the foregoing transcript taken on Friday,
6 A ugust 18, 2017, w as recorded by m e in m achine
7
8 202
JNJAZ55 1096
1217
Rubino, M ortality and M orbidity
7 shorthand and w as thereafter transcribed by me; and
8 that the foregoing transcript is a true and accurate
9
10 11 12 2 0 7
A m ong T alc M iners and M illers in
Italy
JN JN L6153191
1223
R ubino, M ortality and M orbidity
9 verbatim record o f the said testimony.
10 11 12 I fu rth er certify th at I am n o t a relative, em ployee,
13
A m ong Talc M iners and M illers in
13 counsel o r financially in volved w ith any o f the
14
Italy
14 parties to the w ithin cause, nor am I an em ployee or
15
N o B ates
1222
15 relative o f any counsel for the parties, no r am I in
16
16 any w ay interested in the outcom e o f the w ithin cause.
17
17
18
18
19
19 Signed: ............................
20
20 N am e: D E IR D R A JO R D A N
21
21 D ate: ............................
22
22
23
23
24
24
25
25
94 (Pages 1427 - 1430)
Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
1
ERRATA SHEET
Priority-One Court Reporting/Veritext
2
718-983-1234
ASSIGNMENT NO. Pl-2684109
3 CASE NAME; Herford, Verdolotti, Teuscher & Etheridge v.
Asbestos/Johnson & Johnson
DATE OF DEPOSITION: 8/18/2017
4 WITNESS' NAME: Dr. John Hopkins Vol 4
5
PAGE/LINE(SV CHANGE REASON
6 / /_______ /
i
/________________ /
77
/________________ /
7
/________________ /
/ /_______ /
/ J____________ /
9 / /_______ !
/ /_______ !
10 / /_______ !
/ /_______ !
n
i
/________________ !
/
/________________ i
12 / /_______ /
7_______ i________________ !
13 7
/________________ !
7
/________________ /
14 / /_______ !
7
/________________ i
15 /___/_________ /
/
/________________ i
16 / /_______ /
/ /_______ !
17 / /_______ !
/ _ _ _ / _______________ !
/ /_______ ! 18
/
7
19
i________________ i i________________ /
20
Dr. John Hopkins Vol 4
21 (Notary not required in California)
SUBSCRIBED AND SWORN TO
22 BEFORE ME THIS
DAY
OF______________, 2017.
23
24 NOTARY PUBLIC 25 MY COMMISSION EXPIRES.
Page 1431
95 (Page 1431)
Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
1
CERTIFICATE OF COURT REPORTER
2
3 I, DEIRPRA JORDAN, an Accredited Court Reporter, 4 hereby certify that the testimony of the witness, JOHN 5 HOPKINS, in the foregoing transcript taken on Friday, 6 August 18, 2017, was recorded by me in machine 7 shorthand and was thereafter transcribed by m e ; and 8 that the foregoing transcript is a true and accurate 9 verbatim record of the said testimony. 10
11 12 I further certify that I am not a relative, employee, 13 counsel or financially involved with any of the 14 parties to the within cause, nor dm I an employee or 15 relative of any counsel for the parties, nor am I in 15 any way interested in the outcome of the within cause
17
18
19
20
21 Date: 22 23 24 25
3Oth August 2017
,
p
[&-1]
Page 1
_________ & _________
& 1058:16 1059:10 1060:10 1061:9 1062:8,12 1062:13,17,18 1063:9,14,19,23 1064:3,6,7,10,12 1065:3,7,11 1066:25 1067:2,5 1067:12,24 1068:11 1069:3,12 1069:13 1071:9 1074:8,8,17 1076:19,21 1077:7 1077:21 1078:13 1078:23 1079:15 1080:15 1081:1,17 1082:13,14 1086:2 1086:11 1087:13 1088:14 1090:18 1091:1,6,23 1094:4 1095:4 1098:24 1105:13 1107:5,8 1108:14 1108:15,18 1109:10 1111:23 1112:22 1119:4,18 1119:23 1120:21 1121:13 1124:1 1125:17,20,23 1126:16 1127:15 1128:7,20,22 1129:17,20 1130:11,17 1131:4 1131:15,20 1132:9 1132:22 1133:5,6 1133:12 1134:8 1136:22 1137:3,7 1137:12 1140:5,25 1141:8,12 1142:1 1143:3,6 1144:22
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1397:13 1398:10 1398:15,20,25 1399:11,15,18,21 1431:3,3________
______________0 _____________
0.2 1184:11 0.5 1196:6 1326:25
1375:23 00000 1112:1
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_____________ 1 _____________
1 1091:5 1118:16 1148:23,25 1149:1 1149:11 1183:12 1245:23 1262:18 1268:18 1285:20 1288:25,25 1291:7 1314:20 1317:18 1319:8 1323:25 1331:7,13 1332:3
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1096 1428:7 1097 1426:6 1098 1426:12 109t 1371:1
1410:3 10:30 1086:6 10:33 1086:7 11 1085:6 1174:10
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1368:12 1386:10 1386:20 1967 1268:11 1968 1111:10,11 1112:19 1969 1388:24 197 1217:14 1428:3 1970 1081:23 1085:22 1086:11 1250:25 1252:24 1297:19,22 1970s 1068:13 1141:14 1154:19 1154:21 1171:11 1173:18 1182:17 1194:13,17,23 1195:9 1196:14 1326:1 1368:13 1382:5 1971 1084:5,6,20 1085:23,24 1155:4 1155:10 1156:16 1156:25 1165:11 1165:22 1186:1 1269:4 1277:20 1297:18 1397:15 1407:24 1972 1090:20,22 1092:10 1128:12 1161:17 1174:10 1425:15 1973 1183:12 1184:5 1199:17 1214:12 1215:8 1272:22 1289:4 1290:12 1342:10 1421:20 1974 1067:4 1213:8 1216:6,13 1216:24 1217:16
1224:2 1365:24 1370:18 1371:8 1974-1995 1416:17 1975 1097:8 1106:22 1172:7 1288:8 1300:20 1309:4 1345:5 1362:1 1383:6 1408:13,13 1417:23 1976 1067:5,6 1069:4 1187:24 1188:2,9,10 1189:1,12 1191:9 1195:24 1227:23 1233:21 1254:15 1296:1,2 1297:10 1299:2 1323:17 1326:9,18 1390:6 1401:10 1977 1094:18 1133:8,12,14,24 1133:25 1134:2,9 1145:3 1246:20 1322:16 1326:9 1327:22 1356:12 1391:2 1406:1 1978 1255:4,12 1256:3 1979 1118:14 1232:11 1233:17 1248:24 1255:22 1390:6 1404:14 1980 1098:11,13 1980s 1068:13 1246:1 1983 1192:22 1193:16,19 1293:10
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1990 1235:14 1329:12
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226 1133:2,3,21 1137:24 1416:12
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234 1163:22,23 1164:5 1397:8 1417:15
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Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
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1269:18 1270:2,7 1274:7 1295:21 1300:18 1301:15 1308:19 1309:4 1329:25 1334:4 1335:16 1337:4,14 1349:7 1368:2 1369:1,11 1372:7 1381:15,16,25 1382:2 1383:22 1390:13 1397:2,7 background 1070:25 1108:13 1260:17,18 bacon 1058:16 1062:13 bacteria 1143:19 1144:5 bacterium 1144:16 b a d 1075:5 1217:101219:21 1227:4 1335:20 bags 1249:18 1252:6 bailey 1376:23,24 1377:18 balance 1220:15 balanced 1371:21 ball 1114:19,21 1136:1 1420:22 band 1108:24 barely 1249:3,12 b a rtle tt 1062:3 baseball 1114:19 1136:1 based 1089:10 1117:12 1123:20 1134:7 1166:25 1173:8,23 1189:22 1208:25 1215:17
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b ath 1136:9,12 1188:22
battelle 1266:22 1267:7,24 1268:5 1369:11
b au er 1192:9 bc646315 1058:5 bcc 1423:13 b cc'd 1366:3 beach 1064:22 bearing 1371:24 beauty 1188:19 began 1195:20,22
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bell 1058:6 beneficiation
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Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
[biometrics - calculates]
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biom etrics 1216:22 1217:8
b ird 1188:19 b it 1066:12
1067:22 1100:9,24 1109:20 1111:1 1112:15 1121:15 1143:24 1145:5,7 1167:16 1190:18 1276:2 1309:11 1345:25 1381:15 1381:17 bits 1342:3 black 1192:9,9 b la n d 1356:2,7 blind 1366:3 block 1063:4 blockers 1146:3 blood 1073:11,13 blount 1319:23 b o a rd 1076:3 1208:16 1259:24 1261:6 1267:14 1283:11 1300:18 1301:13 1328:8 1348:23 1367:25 1405:6,25 b o ard s 1411:3 bob 1251:10 body 1071:19,19 1072:13 1073:11 1080:9 1112:18 1127:6 1153:15,20 1162:15,21 1188:10,20,23 1192:7 1207:24 1238:20 1299:10 1303:22 book 1123:2 1145:21,22
b o rn 1380:5 bottle 1294:9
1341:9,19 1379:11 1379:13 1410:13 bottled 1294:4,10 1294:12 1295:16 bottom 1091:12 1118:15 1136:14 1325:10 1350:5,17 1353:17 1354:2 1398:2 1410:15 bought 1255:6 bouquet 1192:7 1296:7 1297:18,21 1298:19 1299:10 1299:25 1323:21 1324:3 bowes 1357:4 bowling 1198:22 1198:23 1199:4,9 1199:14,18 1200:7 1200:141201:9 1202:19 1204:1,8 1427:11 box 1062:19 boxes 1110:3 b ran ch 1147:19 1381:17 b ran d s 1296:6 b re a k 1093:3 1108:6 1131:17 1142:19 1154:3 1209:19 1280:12 1301:22 1340:6 1349:20 1350:1 1374:16 breaks 1225:24 b reath 1359:25 breathable 1211:10
b re a th e 1211:11 1360:2
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bringing 1366:19 bristol 1063:12 b rita in 1083:11
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c
c 1062:1,4 1063:1 1063:20 1064:1 1065:1 1123:12,12 1228:23 1293:23 1332:2 1361:16 1391:23
calcium 1148:14 1180:7 1200:11,16 1200:18
calculates 1342:25
Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
[certainly - citizens]
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1171:11 1173:11 1183:6 1196:16 1197:22 1198:4,7 1207:8 1212:12 1227:20 1228:11 1 2 2 9 :2 0 , 2 2 1233:7 1234:3 1237:19 1239:5 1241:21 1267:20 1271:17 1272:5 1280:18 1285:2,19 1324:10 1342:23 1366:14 1379:8,11,20 1380:22 1381:15 1381:16 1382:4 1385:10 1386:14 1386:15 1399:18 1404:21 certainty 1107:22 1246:25 1248:16 1248:20 1250:2,7 1396:5 certificate 1169:12 1429:1 1430:1 certify 1429:3 1430:4,12 cetera 1241:14 1291:10 1350:7 cf 1420:22 chafing 1081:16 chain 1328:15 chairm an 1241:7 chalm ers 1361:16 1394:1 1423:7 chance 1229:22 change 1112:6 1130:16,18 1237:13 1301:23 1309:11 1431:5 changed 1132:4 1134:8 1297:18
1362:9 1398:24 changes 1429:5 changing 1351:23 ch aracter 1158:16
1159:23 1162:7 1339:25 characteristics 1118:19 1362:8 characterization 1100:10 characterize 1093:10 1204:4 characterized 1095:5 charge 1201:24 Charles 1059:3 c h a rt 1150:5 1224:14 1225:19 1372:4 1397:10 1423:23 1424:3 ch artered 1066:23 1071:1 1079:19 chas 1250:25 chase 1062:14 1165:17 chat 1375:19 check 1137:1 1174:23 1202:24 1235:5 1237:4 1270:8 1323:14 1331:4,5 1332:7,7 1332:18 1337:15 1338:2,5 1391:20 checked 1170:6 1270:8 1370:10 checks 1322:10 cheesebrough 1174:17 chem ical 1075:2 1113:61121:10,20 1180:11 1279:25
1362:7 chemicals 1072:10 chem istry 1066:16
1 2 9 0 :1 6 1356:25 1362:11 1423:4 chem ists 1113:7 chen 1361:3 chestnut 1064:13 chewing 1116:15 children 1239:4,6 china 1112:25 1113:1 1129:9,19 1391:8 chnese 1361:3 chisone 1078:7,11 1078:12 1110:10 1110:12 1130:19
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1176:2,4,9,25 1177:4,8,12 1179:17,25 1180:1 1181:10,12 1182:1 1182:14 1184:6,8 1190:5 1203:15 1271:3,6,15 1275:25 1276:4,12 1276:14,17,21,23 1277:23 1278:1,5 1282:19 1284:4,12 1284:19,22 1285:4 1285:24 1287:2,3 1287:4,4,4,8,9,10 1287:11 1291:7,9 1291:12,14,15,17 1291:19,22,23,24 1291:25 1292:1,3 1292:5,9,14,14,15 1292:19,20,24,24 1293:1 1307:14 1332:3 1342:16 1343:1,10,12,24 1344:21 1358:23 1370:21,23 1371:9 1371:10 1397:20 1409:6,20,24 1410:7,11 chunky 1099:25 circle 1365:12 circum stances 1359:12 citing 1327:3,18 citizen 1193:10,25 citizen's 1192:22 1192:25 1193:7,8 1193:16 1209:4,16 1324:19 citizens 1194:14 1325:4 1419:12
Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
[citrate - commercial]
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citrate 1119:11,19 1276:17,22,24 1410:12
citric 1284:20 claim 1139:16
1155:7 1205:20 1267:1 1276:13 1277:25 1287:2 1344:191411:3 claim ed 1185:15 1185:16 1186:6,8 1186:9 1188:4 1371:13 claim ing 1324:5,6 1324:7,14 1343:11 1343:17 claims 1205:10 clarification 1103:19 1104:9,12 1134:12 1224:24 1247:9 1269:12 1356:21 1397:6 clarity 1134:11 d a r k 1059:10 1060:10 1061:9 1062:171174:16 1243:1,5 1244:12 1244:16 1245:3,12 1245:18 1246:20 1247:14 1248:18 1248:22 1249:6 1250:3 1251:1,4,9 1252:23 1253:1 classic 1125:13 1138:17 1150:16 1291:241292:25 classical 1291:9,17 1291:23 classification 1179:16
clean 1095:9 1108:4 1127:10,11
cleaned 1127:7 cleansing 1367:6 clear 1086:15
1103:1 1160:14 1201:23 1206:1 1238:9 1239:23 1259:20 1269:15 1283:19 1294:17 1295:9 1301:19 1373:10 1409:11 clearing 1384:21 clearly 1089:13 1102:5 1104:20 1107:20 1122:2 1125:7,14 1134:16 1227:8 1233:22 cleavable 1205:14 1205:16,18 cleavagable 1204:20 cleavage 1099:18 1204:19 1323:23 1323:23 client 1330:14 clinical 1198:8 clogging 1119:13 1119:17 close 1227:6 1389:8 1398:19 closely 1167:1 1398:7 closer 1306:24 clutch 1166:4 1397:22 1408:3 coal 1087:18 coauthor 1361:13 cobalt 1359:14 coded 1288:6
codes 1427:4 coffee 1240:14 coggiola 1228:21
1228:22,24 1231:5 1234:13 1404:9 1420:7 co h o rt 1191:2 1229:2 1234:11 1420:3 cohorts 1235:6 Colgate 1297:16,17 1297:18,22 colleague 1232:20 colleagues 1174:20 1185:15 1216:15 1222:1 1228:11,12,24 1232:10 1361:24 1373:11 1381:6 1404:9 collected 1158:9 collection 1165:20 college 1083:11 1087:7,11,11 1156:3 1157:23 colleges 1087:20 color 1117:2 1135:5 1169:18 Colorado 1080:5 1080:14,17 1128:11 1155:22 1163:16 1198:21 1199:3,8,16,21 1200:3,12 1201:8 1202:1,20 1204:1 1269:16 1274:9 1368:13,18 1421:13 1424:19 1427:9 colum nar 1099:17
com bination 1313:20
com bine 1237:23 come 1072:23
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Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
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1291:19 1416:9 co m m ercially
1289:5 com m inution
1089:1 1349:18,19 commission
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1129:1 1133:6 1145:9 1150:14 1152:10 1167:25 1168:4,21 1170:5 1171:12 1172:21 1172:22 1173:7 1174:17 1179:10 1179:14 1204:23 1233:18 1239:16 1239:23 1240:6 1241:2,2,8,10,21 1242:1,4 1243:14 1246:13 1247:8 1264:11 1265:2,2 1265:10,25 1272:24 1312:22 1335:13 1347:12 1366:21 1381:13 1383:25 1388:24 1389:11 com p an y 's 1140:11,14 1173:8 1182:20 1381:4 com pare 1222:24 1226:5 1258:18 com pared 1236:25 1288:23 com pares 1226:19 1268:17,19,20 com paring 1255:15 1296:21 1339:10,14 com parison 1143:17 1144:13 1197:9 1223:22 1300:14 1302:15 com petence 1290:19 com petent 1137:17
com petitors 1340:11,12
compile 1218:8 com plete 1376:6 com pleted
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1339:24 com pletes 1080:8 complex 1358:14
1370:10 com pliance
1168:1,24 com ply 1224:7 complying
1148:19 com ponents
1119:6 1162:16 com posed 1366:25 composite 1165:14
1295:24 1321:25 1350:22,23 1351:7 1352:23 1392:2,5 1392:8,12 com position 1088:22 1113:6 1393:3 com prehensive 1141:1,2,3 com prised 1229:3 com prises 1119:7 com prom ise 1093:17 com puterized 1215:12 concentrations 1281:25 1317:17 concept 1385:18 concern 1175:20 1178:25 1193:12 1193:14 1239:15
1240:11 1252:11 1261:15 1312:5 1318:6 1366:19 1399:12 1423:14 concerned 1135:14 1216:18 1216:20 1389:12 concerning 1079:16 1096:9 1098:2 1102:10 1126:3 1152:18 1154:18 1186:4,5 1186:11 1188:8 1197:21 1200:13 1203:8 1209:5 1216:11 1217:17 1217:20 1219:5 1222:1 1229:25 1231:13 1232:21 1234:21 1236:4 1237:2,14 1238:5 1238:19 1239:20 1366:13 1389:19 1394:13 1398:3,21 concerns 1126:3 1240:5,7 1399:3 conclude 1080:25 1081:17 1098:2 1130:11 1152:18 1161:18 1181:1 1182:7 1193:24 1196:21 1207:11 1209:5 1229:7,25 1232:21 1234:21 1236:4,21 1237:2 1238:4 1245:10 1398:11 concluded 1081:3 1081:20 1118:11 1129:21 1173:3 1207:14 1208:13
Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
[concluded - consumer]
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1208:18 1209:9 1229:11 1231:16 1232:24 1273:8 1414:9 concludes 1166:25 concluding 1107:15,16 conclusion 1074:25 1075:6 1088:12 1089:23 1107:21 1159:4,6 1159:12 1172:24 1173:8 1177:14,16 1182:18,20,22 1188:15 1189:1,22 1190:3 1196:18,19 1197:8 1208:10 1231:8 1237:14 1260:20 1261:3,8 1270:9,11 1358:6 1392:6 conclusions 1161:21 1218:5 1268:4 1284:18 1358:5,9 1395:4 1398:3 conclusively 1156:22 1159:15 conditions 1119:1 1305:19 conduct 1151:15 1303:12 conducted 1080:3 1083:18 1194:17 1211:4 1212:18 1269:25 1293:25 confer 1290:21 conference 1362:13,20 conferences 1073:23
confidence 1346:4 confident 1152:10
1262:20 1406:8 confidential
1073:18 1178:7 1204:14 1425:21 1427:13 confirm 1100:25 1104:13 1132:3 1165:2 1179:23 1231:17 1278:5 1336:24 1370:13 1413:4 confirm ation 1168:1 confirm ed 1132:14 1150:11 1262:21 1271:17 1287:6,10 1300:24 1301:18 1302:2 1371:4 1408:25 conform s 1170:10 1170:20 confrontation 1290:18 confuse 1271:14 1312:5 confused 1091:19 1410:11 confuses 1180:1 confusion 1263:16 1276:16 congratulated 1262:19 congress 1372:13 conjunction 1080:20 1135:15 1218:14 connected 1362:23 connection 1066:21 1075:9
1077:4,21 1078:5 1080:15 1081:1 1086:12 1088:13 1091:4,14 1092:4 1094:2,23 1101:3 1105:3 1107:17 1111:23 1112:5 1118:18 1126:3 1133:16 1148:9,17 1150:4,25 1151:9 1154:13 1156:17 1158:3,24 1160:22 1162:12 1163:2 1168:20 1176:1 1178:3 1180:23 1182:16 1183:16 1185:13,18 1186:1 1186:6,22 1191:4 1191:19 1193:17 1193:25 1195:1 1197:1 1198:15 1200:15 1201:6 1202:1,21 1205:4 1207:11 1209:4 1211:13 1212:25 1213:18 1219:8 1220:1 1227:22 1239:16 1389:10 1390:14 1393:24 1394:2 1396:1,15 1411:14 1412:16 conopco 1063:18 consensus 1238:18 consequence 1197:14 consider 1211:1 1260:10 1405:2 consideration 1196:14 1251:15 considered 1130:1 1211:2 1335:10
considering 1259:21 1260:1,3
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1207:16 constitutes
1288:24 consultancy
1074:1 consultant
1069:15,18,22 1083:10 1087:12 1126:14 1128:24 1212:8 1244:8 1261:11 1266:11 1266:15 1290:21 1319:4 1348:5 consultants 1086:4 1094:5 1141:18 1145:12 1163:1 1237:25 1238:19 1337:20 1364:22 consulting 1097:10 1216:21 consum ed 1147:4 consum er 1068:20 1069:201174:13 1177:23 1183:5 1189:21 1208:7 1210:1 1238:22 1239:2 1243:12,25 1244:6 1245:19 1296:2 1339:12 1356:25 1357:14 1358:12,16,21,22 1362:12 1363:20 1369:22 1393:4 1423:5,12
Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
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consumers 1171:14 1174:13 1238:21,24 1248:2 1365:10,12 1366:22 1369:18
contact 1069:14 1117:16
contacted 1261:11 1261:16
contacts 1215:22 contain 1095:9
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1292:12 1371:23 co n tam ination
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contribution 1382:20
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controlled 1264:2 1264:6
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co rn er 1256:2 corp 1058:6 corporate 1074:22
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daily 1233:15 1295:24
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description 1088:24 1121:9 1146:22 1180:11 1215:19 1217:3 1281:17 1304:25 1393:13 1415:14 1416:1 1417:1 1418:1 1419:1 1420:1 1421:1 1422:1 1423:1 1424:1,8 1425:1 1426:1 1427:1 1428:1
descriptions 1135:9
descriptor 1100:15
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designations 1300:7 1413:7
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1371:15 destroy 1284:12 detail 1069:9
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determ inations 1184:19
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Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
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proportion 1193:22 1266:23 1267:8
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public 1072:25 1076:11,17 1187:4 1242:1 1261:17 1315:22 1316:23 1383:2 1424:10,12 1431:24
publication 1223:24 1224:8,21 1225:20 1228:1,5 1228:25 1234:8 1235:13 1253:25 1254:1 1255:19 1256:20,24 1257:16 1362:22 1389:18 1400:8 1401:3 1405:4
publications 1073:23 1198:13 1383:1,2 1389:22 1400:5
publicity 1166:17 publicly 1261:10 publish 1073:20
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Priority-One Court Reporting Services Inc. - A Veritext Company 718-983-1234
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