Document M4ELMEybvMJkgdM7QZMk3rKJ9

VO I Pp. 1-87 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF OHIO WESTERN DIVISION MARY A. ETTA M. DENDINGER, ET AL AND WALLACE, ET AL, Plaintiffs vs. B.F. GOODRICH, ET AL, Defendants ) ) ) ) ) ) ) ) ) ) ) ) ) ) Civil Action No. CG7-7117 (Hon. Nicholas Walinski) 7. Deposition of RICHARD R. MONSON, M.D., Sc.D., taken on behalf of the Plaintiffs, pursuant to the Federal Rules of Civil Procedure, before Wendy Wagner Registered Professional Reporter, a Notary Public within and for the Commonwealth of Massachusetts, at the offices of Irene M. Arabian, 65 East India Row, Boston, Massachusetts 02110, commencing at 12:00 P.M. on Monday, October 17, 1988. IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 1 APPEARANCES 2 KIRK J. DELLI BOVI, Esq. (Murray & Murray) 3 Murray Building 300 Central Avenue 4 Sandusky, Ohio 44870 for Mary A. Dendinger, et al and 5 Etta M. Wallace, et al. Plaintiffs. 6 ROBERT A. BUNDA, Esq. (Fuller & Henry) 7 One Seagate, 17th Floor P.O. Box 2088 S Toledo, Ohio, 43603 for B.F. Goodrich, et al, Defendants, 9 10 11 12 13 14 15 16 17 12 19 20 21 22 23 24 IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 2 0 -E Boston, Massachusetts 02110 (617) 367-8888 ID -U V-CkI 1 INDEX 2 Depos11ion of: 3 Richard R. Monson , M.D., Sc.D. 4 5 DirectCross_________________________ ___________________________Recross 64 81 83 85 7 8 EXHIBITS 9 Nunber_j_______________ __________________________________________ For n t_. 10 1 - A five-page document entitled "Statement for OSHA Hearings on 11 Vinyl Chloride" dated 6/27/74. 26 12 2 - A multi-page document. 26 13 14 15 16 17 18 19 20 21 22 23 24 IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 3 ^n S S tnnyr, 4 1 RICHARD R. MON SON, M.D., Sc.D^ 2 a witness called by the plaintiffs, first having 3 been duly sworn, on oath deposes and says as 4 foilows: 5 Direct Examination a 6 by Mr, Delli Bovi 7 *Q Would you state your full name and home address, 8 please? 9 A Richard Redding Monson, 191 Buckminster Road, 10 Brookline, Mass, 11 Q When did you initially have involvement on a 12 professional level with vinyl chloride? 13 A 1973. 14 Q How did your involvement start at that time? 15 A I was contacted by CMA, Chemical Manufacturers 15 Association, the right of proposal to study vinyl 17 chloride workers. 18 Q Do you recall who at the CMA contacted you? 19 A No. 20 Q Was the contact from the CMA over the phone or in 21 writing? 22 A As best I can tell it was made to someone else at 23 school who then referred them to me. I don't 24 recall anything in writing initially. IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 URL 11457 5 Did you have in 1973 or 1974, prior to the submission of your final report, any written communications with anyone at the CMA? I sent them a proposal but I never received anything in writing from them. Was the proposal submitted in 1973? Yes. What was your understanding of what the CMA wanted from you in terms of a proposal? They wanted a study of people who worked with vinyl chloride basically a mortal study. Did they indicate to you, that is the CMA, why they wanted this study conducted? A As best I recall it had to do with work, the work from Italy on the effects of vinyl chloride in rats. , iii j 0 Prior to the contact from the CMA were you aware of the results of the Italian studies? MR. BUNDA* Objection to the form of the question. I'm not sure that there were any Italian studies meaning more than one but nevertheless you can go ahead and answer. A I don't remember. Q Did the CMA indicate to you whether they wanted ________________ IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8B88 ___________________ 6 1 you to study workers involved in the production of 2 vinyl chloride monomer, workers involved in the 3 production of polyvinyl chloride, workers involved 4 in the use of polyvinyl chloride resins or all 5 three? 6 A Again, I don't remember what they asked for. VJhat 7 I proposed was people who produced polyvinyl 6 chloride, PVC. 9 Q Did the CMA, when it contacted you in 1973, 10 indicate the identities of the companies that 11 would be supporting any vinyl chloride research? 12 A I don't recall. 13 Q Do you have a copy of the proposal that you 14 submitted to the CMA in 1973? `S P % c-1 15 A Yes. 16 Q Do you have it withyou? 17 A I don't have it with me. 18 Q What was the scope of your proposal in terms of 19 the worker population that you anticipated 20 studying? 21 A As best I can recall it was -- well, I don't think 22 I knew what the worker population was to be 23 specifically. I basically designed a study that 24 would be applied to a general study design. IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E___________________________________ Bo s ton, Massachusetts 02110 (617) 367-8888 7 1 Q Did the CMA discuss with you focusing on 2 particular health effects related to vinyl 3 chloride exposure? 4 A I think cancer was the main health effect that 5 they were concerned about. 6 Q What type of study did you propose to the CMA? 7 A I proposed initially doing a proportional 8 mortality study which would be an analysis of 9 death certificates. And I also proposed a 10 retrospective cohort study where workers would os 11 followed up for mortality. 12 Q Was the PMR study that you proposed one that would 13 encompass all deaths? 14 A Yes. 15 Q Did you propose a cancer proportional mortality 16 ratio study? 17 A I don't recall if I did or not. 18 Q What would be the difference between the two? 19 A Well, on a proportional mortality study you 20 basically compare a cause of death as a proportionj 21 of all causes of death. And a proportional cancer 22 mortality study you would take a specific cancer 23 as a proportion of all cancers. And at the time I 24 was writing this computer program where one IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E Boston, Massachusetts 02110 (617) 367-8885 URL 11459 3 analyzes both types of things and it is something I would sort of do as part of any study. So the PCMR would be subused in the PMR study. It's not something you automatically do but it's something you consider. Q Have you at any time before today attempted to take the proportional mortality ratio study that Dr. Chiazze did at Georgetown and determine PCMRs? A One can do it with the data he has. One can approximate it. 0. Have you done it or have you approximated it? A I've approximated it. Q What have you determined in terms of PCMRs using Dr. Chiazze's data for total cancers, other and unspecified cancers, buccal cavity cancers and colon cancers? A Can I look at the paper? 0 Certainly. A Table VI, Page 627. Q Which paper are you referring to now. Doctor? A This is the 1977 Journal of Occupational Medicine paper. 0 Go ahead. A You want actual numbers? I can compute the IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E___________________________________ Boston, Massachusetts 02110 (617) 367-8880 URL 11460 1 numbers with a calculator. 9 2 Q Certainly if you can do that this morning I would 3 prefer. 4 A Well, for males the -- PMR is the same as * 5 proportional mortality ratio so I'll just say 6 PMR -- the PMR on all cancers is 119. 7 Now what specifically did you want in 8 terms of proportional cancer mortality? 9 Q Colon. 10 A One can approximate the proportional cancer 11 mortality by dividing the cause, specific PMR by 12 the all cancer PMR. So, for colon which is the 13 same as intestinal I would divide the intestinal 14 PMR which is 139 by the all cancer PMR which is 15 119. So 139 divided by 119 is 117. 16 Q And what about for.females? 17 A Females would be 156 divided by 131 which is 119. 18 Q Using Dr. Chiazze's results how would you classify 19 a parotid gland cancer? 20 A I assume it's under buccal cavity and pharynx 21 although I don't know for sure. 22 Q Have you attemped to determine prior to today 23 whether the PCMRs for colon cancers in men and 24 women reported by Dr. Chiazze are statistically U fiL V B t'l IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 10 1 significant? 2 A Not formally, 3 Q Have you attempted to do so informally? 4 A Well, let's see, one can't actually do it with 5 these data in a formal sense because you don't 6 have the actual data that Chiazze used. 7 Q Have you at any time requested any of 8 Dr. Chiazze's raw data or attempted to obtain it? 9 A NO. 10 Q Did Dr. Chiazze determine that the PMRs for colon 11 cancers among both white males and white females 12 were statistically significant? 13 A I'll have to look and see, it doesn't seem to be 14 in the table. I don't see any results where he 15 did but he may very well have if I read through it 16 careful 1y. 17 0 When you designed your proposal to submit to the 18 CMA in 1973 what was your result for proposing 19 both a PMR study and a retrospective cohort study? 20 A I'm sorry, proposed both the PMR and the 21 retrospective cohort? 22 Q Yes. 23 A The PMR was to give results as quickly as possible 24 because one has to have only death certificates to IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 11 1 do that . The problem that might arise from a PMR 2 study is that you don't have all the death 3 certificates on a defined group of workers. 4 With the retrospective cohort study 5 you would follow-up workers in the factory and get 6 death certificates on people who have terminated, 7 on people who have died while working or while 8 retired and then one can compare death rates than 9 death proportions. 1 0 Did the CMA indicate during your discussions with 11 it in 1973 what they were looking for in terms of 12 bottom line results, that is what they wanted you v-u W . 13 to determine was either true or not true? 14 A As best I recall they wanted the study done and 1 that's what I remember* ijj 16 Did you submit a joint proposal to the CMA with 17 any other researcher? 18 A No# I was the only one that was the author. 19 Q The CMA did not accept your proposal? 20 A Yes. 21 0 Why was that? 22 A I don't know. 23 0 Did you ever have any discussions with anyone at 24 the CMA as to why your proposal was not accepted? IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E Boston, Massachusetts 02110 (617) 367-6888 12 1 A I don't believe I did. 2 Q The CMA instead accepted the Tabershaw proposal? 3 A Yes. 4 0 How did his proposal or the workultimately done 5 by Tabershaw differ from what you had proposed? 6 A They ultimately published a retrospective cohort 7 study. 8 Q Did Tabershaw to your knowledge do a PMR study 9 initially? 10 A Not to my knowledge. 11 Q were you furnished with any information in 12 document form by the CMA in 1973 in connection 13 with your proposal submission? 14 A I don't believe so. 15 o Did the CMA indicate to you whether the type of 16 study that they wanted done had ever been done by 17 anyone before? 18 A I'm not sure I follow. What do you mean by "type 19 of study"? 20 Q Either a PMR study or a retrospective cohort study 21 that inquired into potential vinyl chloride 22 carcinogenic!ty? 23 A Did they indicate a study -- had a study been done 24 of vinyl chloride workers or are you just talking IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617 > 367-8888 13 1 in a general sense? 2 Q I'm talking about the epidemiologic studies 3 dealing with vinyl chloride and cancer. 4 A I don't recall. I don't recall if they did. 5 Q Have you determined prior to today whether or not 6 any epidemiologic studies were done to your 7 knowledge by the CMA or the PVC resin industry 3 prior to 1973 dealing with vinyl chloride 9 UW.V146 ID A Have I determined that studies have been done? 11 Q Have been done or have not been done. v 12 A I haven't determined either way. I'm not aware 13 that any was done. 14 Q In connection with the literature review that you 15 did for Mr. Bunda, have you reviewed any of the ! I 16 scientific or medical journal papers or articles j 17 prior to 1970 dealing with the health effects j i 18 associated with exposure to vinyl chloride? 19 A I've looked in the past on health effects related 20 to acroosteolysis. 21 Q Was this before 1973, during 1973 or after 1973? 22 A I was aware of that particular relationship. I'm 23 not sure when I became aware of it. 24 Q How much time elapsed between your initial IRENE M. ARABIAN, CSR/RPR 65 East India Row,__________________________Suite Boston, Massachusetts 02110 (617) 367-8888 20-E 14 1 proposal submission to the CMA and its rejection? 2 A I don't recall. 3 MR. BUNDA; I'll object to the 4 characterization of "rejection." I think that is 5 a mischaracterization of was his testimony has 6 been. 7 Q Did the CMA accept your proposal? 8 A They didn't fund it. Q Q Do you recall when in 1973 your proposal was 10 submitted to the CMA? 11 A I thin* it was in the spring or early 1973. 12 Q T/?hen did you receive word that the CMA would nor 13 fund your proposal? 14 A I don't recall. 15 3 Do you recall whether it was in 1973? '>&c 16 A I believe so but I don'tspecifically recall. 17 0 Did you submit a proposed cost to the CMA along 13 with your proposal? 19 A I don't believe so* 20 Q What was your next involvement with the vinyl 21 chloride chemical following your contact by the 22 CMA in 1973? 23 A When Maurice Johnson reported the three cases of 24 angiosarcoma among workers at one Kentucky plant I IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 15 1 guess -- let's see, how did it go? Johnson worked 2 for Goodrich so I knew this was a Goodrich plant. 3 And since 1971 we had been studying 4 rubber workers at Goodrich, As part of that study 5 I was collecting death certificates,for all of 6 B.F, Goodrich, And what I had done was taken the 7 rubber worker death certificates and put them in C my study pile and all the others I put in another 9 pile. 10 And when Maurice Johnson reported the 11 three cases of angiosarcoma I went to the other 12 pile and pulled out certificates from Kentucky for 13 people who had been working at the two plants that 14 Goodrich had in Kentucky, 15 O Did you as a result of your inspection of those 16 death certificates discover whether or not there 17 were angiosarcoma cases at the BF,G, Louisville ; ie facility in addition to those reported by Mauricc.19 Johnson? 20 A Eventually I did, I don't know whether they were 21 there at the time. What I did after that was I 22 was in touch with the people at CDC, we eventually 23 worked with Waxweiler on the NIOSK study. 2 4 I think I also got some death IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-Ej Boston, Massachusetts 02110 (617) 367-8888  16 1 certificates from Goodrich, I think more were 2 coming in. I was getting certificates regularly 3 and whether the cases with angiosarcoma were there 4 at the time I pulled them out of my file or 5 whether they came over the next six months I'm not 6 sure. 7 Q Do you recall how many total angiosarcoma deaths S have been reported to date out of that 9 3.F. Goodrich facility in Kentucky? 10 A Uc 11 0 Have you performed work in the past for any of the 12 following companies: Firestone? 13 A Ho. 14 Q Conoco? 15 A No. 16 C Tenneco? 17 A No. I hesitate only because I send a computer 18 program to people who work for some companies but 19 I don't do any work for them so I provide them a 20 service. 21 Q Occidental? 22 A NO. 23 Q Union Carbide? 24 A I may have consulted once with an epidemiologist. IRENE M. ARABIAN, CSR/RPR 65 East India Row# Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 89V URL 11469 1 Q Do you recall who that was? 17 2 A Susan Austin. 3 Q What did it concern? 4 A I'm not even sure that I did. I know I talked to 5 her once and whether it was informal or formal I 6 don't recall. 7 Q Do you recall whether or not one of the topics of B the consultation was vinyl chloride? 9 A I'm quite sure it wasn't. The topic, had I done i 10 any formal consulting, would have been in the use 1 1 of my computer program. 12 Q Have you done any work in the past for Uniroyal? 13 A No. Again, with Firestone andUniroyal they were 14 a part of the rubber worker study we were invclvodj 15 in but they worked with the university of North 16 Carolina. We had a certain amount of contact with 17 them but never any funding through them or worked IS for them. 19 0 Diamond Shamrock? i 20 A No. 21 Q What PVC manufacturers other than Goodrich 22 participated in the Harvard study? 23 A Well, the Harvard study was only with Goodrich and 24 URW, United Rubber Workers. We also did a rubber IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8088 URL 11470 13 1 worker study with Armstrong and one with, I think 2 Mansfield was the other one. Whether they make 3 PVC or not 1 don't know. 4 Q The work that you did for Goodrich was reported in 5 the Lancet in 1974? 6 A I wouldn't say work "for Goodrich," it was funded 7 by Harvard. e Q Who was it funded by? 9 A Harvard. 10 Q Did Harvard have acontract withGoodrich? n A Yes, we had acontract with Goodrich and UP.W to 12 study rubber workers, this was outside of the 13 contract. 14 Q How long had Harvard been under contract with 15 Goodrich? 16 A Since 1971. 17 Q When that contract was first funded in 1971 did 18 Goodrich determine or did Harvard determine 19 whether there were particular chemicals utilized 20 in the rubber industry that would be the subject 21 or the focus of the study? 22 A I don't think either determined at that time that 23 there were specific chemicals to be studied. The 24 intent was for Harvard to write a study proposal IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 19 1 to Goodrich and to URW. 2 Q Did Harvard propose, when it submitted that 3 document, looking at any particular chemicals 4 utilized in the rubber industry? 5 *A There were several studies proposed but I think the best way to characterize them was the 7 mortality study and the morbidity study. I did 8 the mortality study and that was a general survey O of the mortality among Goodrich workers in Akron. 10 0 Was there any focus prior to the 1974 Maurice 11 Johnson announcement on vinyl chloride ac it 12 related to the 1971 proposal that was submitted to 13 Goodrich? 14 A No, because that wasn't a UR'/J plant so that wasn't 15 part of our contract at all. IS Q You reported in the Lancet article in 1974 what 17 you characterized as an unusual cancer of the 18 nasopharynx. 19 A I don't have the paper. 20 Q Certainly. 21 A One thyroid and onenasopharynx. 22 Q Do you classify -23 MR. BUNDA: Where is the reference 24 you're pointing to for "unusual"? IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E___________________________________ Boston, Massachusetts 02110 (617) 367-8888 URL 11471 20 1 MR. DELLI BOVXs The word "unusual" is 2 contained on Page 2 of that article. 3 A Right here. 4 MR. BUNDAs No, the reference is there 5 were two unusual other types of cancer, thyroid 6 and nasopharynx. 7 0 Is the nasopharynx an unusual cancer? 8 A Yes. 9 0 Is that classified as a buccal cavity cancer? 10 A It would be under buccal cavity and pharynx, 11 that's the grouping. 12 Q Have you attempted to determine prior to today the 13 the rate at which people in the United States die 14 from buccal cavity cancers? 15 A Well, I have the rates in my computer program so 16 there is some number of rate of dying, yes. I 17 can't tell you what it is. 10 Q Do you have an estimate as to the percentage of 19 buccal cavity cancers as compared to total 20 cancers? 21 A No, I don't. 22 Q Do you know whether or not it's less than 23 1 percent? 24 A I don't know. I would have to look it up. It's IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 URL 11472 21 1 very age dependent so it depends on which age 2 group you are talking about. 3 Q In what way are those cancers age dependent? 4 A All causes of death usually have different rates 5 and different proportions by age. If you're 6 talking about proportions it's harder to tell 7 whether they go up or down with age. Obviously 8 death rates go up with age. 9 Q Have you looked into buccal cavity cancers or more 10 particularly parotid gland cancers and attempted 11 to determine the extent to which those are age 12 dependent ? 13 A No, I haven 1t s-->i 14 Q Did you submit any papers to Goodrich reporting 15 the results of your study other than the paper 16 that was published in the Lancet? 17 A I'm sure we sent drafts to them but nothing ie independent other than the draft. 19 Q Did Goodrich at any time make any changes i 20 editorial or otherwise in any of the drafts that 21 you submitted to it? 22 A I'm not aware that they did, they may have. 23 Q Was any restriction imposed on you by Goodrich at 24 the time you were commissioned to do the study IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 URL 11474 22 1 with respect to either the use of your raw data or 2 the publication of your results? 3 MR. BUNDAs Let me just interject 4 here for a second. Are you talking about the 1971 5 study that was jointly funded by Goodrich? 6 MR. DELLI BOVI: No, I'm talking about 7 the 1974 study. 8 MR. BUNDAs I'm confused because I'm 9 not sure that Goodrich commissioned the 1974 10 study. My understanding from the testimony was 11 that he did that and it was funded by Harvard. 12 I'm not sure you ever established that Goodrich 13 asked him to commission the study in '74. 14 0 Did Goodrich commission any study in '74 either of 15 you or Peters or Harvard concerning vinyl chloride 15 17 A No. 18 Q Did Goodrich impose any restrictions on you or 19 Peters or Harvard concerning the use of the death- 20 certificates which they forwarded to you after the 21 announcement of Maurice Johnson? 22 MR. BUNDAs Obviously I think that's a 23 mischaracterization We haven't established that 24 they forwarded any death certificates after IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 URL 11475 1 Maurice Johnson. 23 2 I believe the testimony was that he 3 already had those from his earlier study of the 4 overall rubber worker population. I object on the 5 basis it mischaracterizes the evidence and 6 therefore is improper. 7 Q Dr. Monson, you got additional death certificates B from Goodrich after Maurice Johnson's anoucement, o correct ? 10 A Yes. 11 0 When Goodrich forwarded those additional death 12 to you did they impose any 13 restrictions on your use of those cs or 14 the data that you gathered as a result of the use 1 5 of those death certificates? 16 A I don't believe so 17 Q Did you and Peters first report the results of 18 your *74 study to the Occupational Safety and 19 Health Administration? 20 A First report, I don't believe so 21 Q The article in the Lancet was published in August 22 of 1974? 23 A Right 24 Q Is that correct? IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E Boston, Massachusetts 02110 (617) 367-8688 24 A Yes. Q Do you recall when it was submitted? A I suspect it was submitted in June or July. They have a pretty good turnaround. It may have beerf May or June. Q That report that was published in the Lancet was a PMR study? A Yes. Q Did you have at any time after you submitted that report an opportunity to do a retrospective cohort study of the Goodrich employees? A No. Q Did you propose doing such a study? A No. Q Were you asked by Goodrich to do such a study? A There were already two such studies going on. Q Thosewere which ones? A The NIOSH oneand the Tabershaw one. Q Did either of those studies deal exclusively with the Goodrich plants? A No. Q Do you know whether Tabershaw or NIOSH ever broke down the retrospective cohort studies that they did on an individual plant or an individual PVC IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 1 manufacturer basis? 25 2 A I don * t know. 3 Q Do you have an opinion today as to whether such a 4 breakdown of the industry-wide data for individual 5 plants or individual resin manufacturers would be 6 helpful? 7 MR. BUNDA: For what? I'm going to 3 object to the form of the question on the basis of 9 relevancy and vagueness. 10 Q You can go ahead and answer. V"ItiO 1 1 A Would you repeat the question? 12 MR. DELLI BOVI: Could you read it ----js 13 back, please. 14 (The last question was read. ) 15 A I haven't thought about it. The study we did was j 16 the two B.F. Goodrich plants that was separate. 17 Beyond that I can't think of any specific reason IS why it would be helpful unless one had more 19 information about the plants, i 20 Q Were you originally scheduled to appear before 21 OSHA in June of 1974 along with Dr. Peters? 22 A I don't believe so. My recollection of what 23 happened before that time was that there was a 24 meeting, I thought it was in New York, that IRENE M. ARABIAN, CSR/RPR 6 5 East India Row,.__________________________Suite Boston, Massachusetts 02110 (617) 367-8888 2Q-E-----------------  26 Selikoff organized. I know Peters went somewhere ! and gave a presentation, a verbal presentation. 3 And whether it was New York or OSHA I don't 4 remember specifically what the context was. 5 Q Did you participate in the New York Academy of 6 Sciences Conference on vinyl chloride in 1974 or 7 1975? 8 A NO. 9 MR. DELL I BOVI: Would you nark those 10 two for me. 11 (A five-page document entitled 12 "Statement for OSHA Hearings on Vinyl 13 Chloride" dated 6/27/74 was marked as 14 Plaintiffs* Exhibit No. 1 for 15 Identification.) 16 (A multi-page document was marked as 17 Plaintiffs* Exhibit No, 2 for 19 Identification.) 19 Q Have you had any contact either verbal or direct 20 written contact with either Dr. Doll, Dr. Chiazze, 21 Dr. Harbison, Dr. Zenz, Dr. Shindell or Mr. 22 Peterson in connection with this case? 23 A No. I've met Chiazze recently but we haven't 24 talked about this case. I met Doll last year but. IRENE K. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 URL 11478 -1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 27 again, we didn't talk about the case. Q Did you have any discussions with Dr. Chiazze concerning vinyl chloride when you met with him? A No. Q Would you take a look at plaintiffs' Exhibit 1 Monson and identify it for me if you can. It says "Statement for OSHA Hearings on Vinyl Chloride," June 27, 1974. Do you recall whether that statement was jointly prepared by you and Dr. Peters? A It wa s, yes. MR. BUNDAs Just a second, let him read it. A Okay. Q You've had an opportunity to review that submission, Doctor? A Yes. Q You reported to OSHA in June of 1974 that the observed cancers at the Goodrich facilities which I you studied exceeded by 50 percent the number of cancers expected. A Right. Can I see the paper? I think these are the same numbers in the paper. I just want to check to make sure that they are. IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 URL 11479  23 1 Q Sure. 2 A These are the same numbers as in the Lancet paper. 3 Q Have you attempted to determine at any time prior \ 4 to today what the reason for that increase was? 5 A I'm not sure what you mean by "determine." 6 Q Have you rendered an opinion or do you have an 7 opinion as to what the reason for that 50 percent 8 increase in observed cancer deaths over expected 9 cancer deaths at the Goodrich facilities was? 10 A Most of it was due to an excess of liver cancer. 11 There were a total of 13 excess deaths, 13, 12 observed number is 13.1 greater than the expected 1 3 number. 7.3 of that is due to liver cancer of the 14 biliary tract. 15 0 And my question, Doctor, is whether you have an 16 opinion as to what the reason was for the 17 50 percent increase in observed versus expected 18 cancer deaths at the Goodrich facility? 19 MR. BUNDAs I object. I think that's 20 been asked and answered. The doctor indicated it 21 was liver cancer. 22 Q You can go ahead and answer. 23 A Can you phrase it in a different way? 24 Q Sure. Why were people who worked at the Goodrich IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 URL 11480 29 1 plant dying of cancer at greater than expected 2 rates? 3 A Well, my presumption was it had something to do , 4 with the exposure in the work place. 5 Q To what? 6 A Vinyl chloride, 7 Q Have you formed anopinion prior totoday as to 8 whether or not that was the probable cause for the 9 increases in the cancer death rates? 10 A Well, cancer proportions. 11 0 Cancer proportions. 12 A But in a proportionalstudy there is usually one 13 reason for an increase, just the methodology that 14 proportion cancer tends to be higher in all 15 proportional studies so that's just an artifact 16 way the data is analyzed. But beyond that I 17 presume that the angiosarcoma was due to vinyl 18 chloride monomer exposure. 19 Q What about the brain cancers? 20 A When we reported this we reported five observed 21 brain cancers and 1.2 expected. Z point out that 22 there were other cancers where the observed number 23 was greater than expected and I have kept an open 24 mind whether or not the other cancers that URL 11481 IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 30 1 occurred were due to vinyl chloride or not. That 2 literature has been not consistent on other 3 cancers. 4 Q Do you have an opinion today as to whether or not 5 vinyl chloride causes cancers or probably causes 6 cancers other t&an angiosarcoma of the liver? 7 A I would say possibly causes cancers other than 8 angiosarcoma. 9 0 And do you have an opinion today as to what 10 cancers vinyl chloride possibly causes other than 11 angiosarcoma of the liver? 12 A The three that have been on the possible list I 13 think in most people's minds has been brain 14 cancer, lung cancer and lymphatic hematopoietic, 15 those are the three categorizations that have been 16 reported in some studies but not in other studies. 17 0 What are the cancers that are on your possible 13 list? 19 A Those three groupings. 20 Q When this statement marked plaintiffs' Exhibit 21 Monson 1 was submitted to OSHA in June of 1974, 22 did you agree with the last sentence of the 23 statement that reads "At this point the only way 24 to assure an end to this this serious hazard is to IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 30-E__________________________ Boston, Massachusetts 02110 (6171 367-8008 1 eliminate exposure." 2 A Yes. 3 Q Do you agree with that statement today? 4 A Yes. i 5 Q Have you had an opportunity before today to reac 6 Dr. Peterson's testimony before the Occupational 7 Safety and Health Administration in 1974? 8 A Is that Peterson or Peters? 9 0 Peters, I'm sorry. 10 A I don't recall that I have. I may have read it at 11 that time but I don't recall. 12 0 I'm going to hand you plaintiffs' Exhibit 13 Monson 2. Would you take a look at that document, 14 read it if you wish and identify it for me if 15 you're able to. 16 A What do you mean "identify it"? 17 Q Have you seen that document before? 18 A I don't recall that I have but I may have. 19 Q Would you take a look through the document and 20 tell me whether a review of it refreshes your 21 recollection as to whether or not you've seen it 22 before? 23 A I'll go through it quickly. 24 MR. BUNDA: Take your time. You're JRL 1143 IRENE M. ARABIAN, CSR/RPR _______________________65 East India Row. Suite 20-E_________________' Boston, Massachusetts 02110 (617) 367-8888 entitled to look at it. 32 MR. DELLI BOVI: Certainly. THE WITNESS: Do you want to look at it? MR. BUNDA: Yes, I do. Q Dr. Peters indicated on the first page of his statement to OSHA "But we wish to stress two points; One, multiple cancer sites seem to be involved and two, cancer is increasing over tine in this population." Did you in 1974 agree with those points expressed by Dr. Peters? A Yes . i--2CD dr otrx. Q Do you agree with them today? MR. BUNDA; About whether he said their, then or whether they were true then or whether they are true today? Q Whether they were true then. A They were true then based on the data that we were presented. Q What about today? A In terms of -- I guess I'm not sure of your question. Do I feel any different today about what was said then or do I feel that there is IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 URL 11485 3 3' 1 increasing cancer today relative to 15 years ago? 2 Q Let me ask you how you feel today about what was 3 said by Dr. Peters in 1974. 4 A I agree with what he said in 1974. 5 Q Do you believe today that he would have reached 6 the halfway point in terms of the occupational 7 cancer deaths caused by vinyl chloride exposure? 8 A I don't know. 9 Q Having reviewed plaintiffs' Exhibit Monson 2 is 10 your memory refreshed as to whether you've seen 11 that document before? 12 A I don't recall. I haven't seen it. 13 Q Dr. Peters was asked at Page 779 of the OSHA 14 hearing transcript, "Doctor, of the workers who 1 0 have already been exposed to high levels or any 16 levels over a long or short period of tine would 17 you recommend any further exposure?" Dr. 18 Peterson's answer was "I recommended no exposure 19 for anybody." 20 Can you tell me whether or not I've 21 accurately read the question and the answer. 22 A Again, it's Peters not Peterson. 23 0 I'm sorry. 24 A I'm sorry, again, did you switch the page? IRENE M. ARABIAN, CSR/RPH 65 East India Row. Suite 20-E Boston, Massachusetts 02110 (617) 3 67 - 8 8 8 B 34 0 Starting on the bottom of Page 779. A Now what's the question? He said that, yes. MR. BUNDAs That's what the document * says. Q` Let me ask you. Dr. Monson, the same question that Dr. Peters was asked in 1974. Doctor, of the workers who have already been exposed to high levels or any levels over a long or short period of time would you recommend any further exposure? MR. BUHDA: I'm going to object to the question on the basis that the word "workers" il vague and ambiguous. A Are you casting this question as if it were 1974? Q No, I'm casing this question as if it were October 17, 1983. A I'm still not sure of the context, that's the problem. Also any answer 1 give will be as an epidemiologist rather than as a clinician, Q Certainly A Dr. Peters was a clinician partially where I've never been a clinician. I can't see where anyone would recommend exposure to anybody in the work place. _Q What about exposure to substances shown to have IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 U fil \ 1436 URL 11487 1 caused cancer In humans? 35 2 A Again, there is no reason why a physician would 3 recommend exposure, I mean that isn't the proper 4 context 5 Q As an epidemiologist today would you recommend or e advise against the exposure of any vJorker to vinyl 7 chloride monomer? 8 A One makes recommendations as an epidemiologist to 9 minimize exposure to all substances in the work 10 Place 11 Q So your recommendation today would be what? 12 A I think the phrase that is used a lot and that I 13 think is a good working rule is "as low as 14 possible . " 15 Q You discussed the PMRs for cancer in one of your 16 earlier answers in connection with death rates for 17 all causes among industrial populations. is it 1C your opinion that when industrial populations are 19 studied the PMRs for all cancers are normally more 20 than one? 21 A Yes. 22 Q In what range would you place them in the normal 23 context? 24 A I think over the years I've said anywhere between IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E Boston, Massachusetts 02110 (617) 367-8388 URL 11488 1 10 and 20 percent. 36 2 Q What is the reason for that? 3 A Because causes other than cancer tend to be less 4 than one. 5 0 Did you write an article in the Journal of 6 Occupational Medicine in June of 1976 entitled 7 "Observations on the Healthy Worker Effect? 8 A 1986. 9 Q 1986. 10 A Yes . 11 Q Are the opinions that you expressed in that 12 article in 1986 of the same opinions that you hold 13 today with regard to the healthy worker effect? 14 M?.. 3UNDA: I'm going to object unless 15 you can make specific reference to what opinion 16 you're describing so he can understand the 17 context 18 Q You can go ahead and answer if you can. 19 MR. BU1JDA: Do you understand what 20 opinions he's talking about? Generally a lawyer 21 will trick you to buy into the whole article and 22 then comes back and asked you whether -- 23 MR. DELLI BOVI: I'm going to object 24 to Mr. Bunda. Either he can answer the question IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E_____________________________________ Boston, Massachusetts 02110 (617) 367-8888 fi8bit iy 37 or he can't answer the question. He doesn't have to be coached by you and I don't need your 3 characterization of my questions because that's 4 not my intent * 5 MR. BUNDA: Why don't you make 6 specific reference to what opinions you're talking 7 about. I think it's unfair to take the whole 8 article and broadly ask that question so I'm going 9 to object to the form of the question. 10 0 VJould you read the summary of that article# 11 Doctor# and tell me whether the opinion expressed 12 in that summary is the opinion that you hold 13 t oday ? 14 A Yes. 15 Q Now on Page 431 you indicated in the second 16 paragraph from the bottom# the left-hand column 17 "This observation has led to a view that the HV7D 18 is of little or no consequence in interpreting 19 data on cancer mortality." Is that a statement 20 that you made in 1966? 21 A Yes. 22 Q Do you agree with that today? 23 A Yes. 24 0 Thankyou. IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E Boston, Massachusetts 02110 (617 ) 3 67-B 8 8 8 i 39 1 0 Do you have an opinion as to the duration of the 2 healthy worker effect among vinyl chloride workers 3 or workers occupationally exposed to vinyl 4 chloride? 5 A I have no information on vinyl chloride workers 6 separately from other workers* 7 Q What about your review of the medical or e scientific literature on that issue? 9 A I'm not sure that I looked specifically at healthy 10 worker effect questions in vinyl chloride workers, 11 I may have but I don't recall having done it. 12 Q Would you take a look again at Page 431 of the 13 article. A reference to Fo;: and Collier indicates 14 Fox and Collier observed that in their cohort of 15 vinyl chloride workers the HWE last about 15 16 years. 17 A I said that's in one study, yes. 10 0 Have you reviewed prior to today any other studies 19 that reported different duration of the healthy 20 worker effect in vinyl chloride workers other than 21 that reported by Fox and Collier? 22 A I've reviewed other studies. I don't recall, I 23 don't recall what other studies said about healthy 24 worker effects. IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 nan 39 0 What effect would a 15-year healthy worker effect duration for vinyl chloride workers have on a 3 proportional mortality ratio study? j 4 A I*m not sure I follow your question. The 15 yearsj 5 they use as an example for vinyl chloride workers 6 I think is common for all populations so it's a j i 7 general question you're asking rather than a B specific one. j 9 0 For all 10 A Yes, as industrial populations? a first approximation, i 11 0 When you reported the results of your study of 12 B.F. Goodrich workers in the Lancet in 1974, did 13 you make any assumptions about the duration of the 14 healthy worker effect? URL 11491 15 A Ko. 16 Q Assuming that you used a 15-year healthy worker 17 effect duration, do you have an opinion as to 1C whether that would have an effect on the expected 19 number of cancer deaths reported in your 1974 20 article? 21 A It's hard to tell because there is really two I I 22 parts to the healthy worker effect. There is this! 23 15-year average that Fox and Collier reported and 24 that other people sort of talked about, that tends IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 URL 11492 i. 40 1 to wear off* 2 There is also the general question of 3 comparing an employed population to the general 4 population which may last for the entire length of 5 follow up so there is really two parts to the 6 healthy worker effect* 7 Q Based on your review of the literature when was 8 vinyl chloride first reported to be a suspected 9 human carcinogen? 10 A I'm not quite -- what do you mean by the term 11 "suspected human carcinogen"? It was first 12 reported -- let's see, the angiosarcoma were 13 reported cases, were reported at the end of 1973. 14 And I think the rat or other data were reported in 15 *70 or '71* 16 Q One of the articles that you reviewed prior to 17 today was an article by Dr* Viola appearing in IS Medicina del Lavoro. 19 A An article or a paper? 20 Q A paper. 21 MR. BUNDA: I'll object to the 22 question. I think it was a translation* 23 A There is a report here, there is three separate 24 Viola things. IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 41 2 You authored a document dated March 24, 19S8 entitled "Review of Epidemiological Literature on Health Effects on Vinyl Chloride." h Right, 3 Was the 1970 Viola paper which you reviewed or the translation of that paper the same translation that I'm now handing you that has previously been marked as plaintiffs' Exhibit Wheeler 4 and also bears the number of other exhibit stickers? A Yes. MR. BUNDA: Well, for the record '.*c should indicate that the article that X provided to Dr, Monson came from plaintiffs' counsel anu it differs in respect that the one that he saw did not have all the exhibit stickers on it but essentially it's the same copy. Q Have you reviewed any other translation of Dr. Viola's 1970 article other than the one that bears the sticker plaintiffs' Exhibit Wheeler 4? A I don't recall that I have. Q Do you have anopinion# Dr. Monson,as to how or the routes by which vinyl chloride gets into the body? A Well# I guess my opinion is that it's inhaled. 6Hnun ___________________ IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E______________ _ Boston, Massachusetts 02110 (617) 367-8886 A. 42 1 Q Do you have an opinion as to whether or not it can 2 be ingested? 3 A I don't have any opinion. 4 Q Do you have an opinion as to whether or not it can 5 be absorbed through the skin? 6 A I don't have an opinion* 7 Q Do you have an opinion as to how vinyl chloride is 8 metabolized once it enters the human body? 9 A No. 10 0 Do you have an opinion as to the metabolites 11 either primary or secondary of vinyl chloride? 12 A No. 13 Q Do you know or do you have an opinion where in the 14 human body vinyl chloride is metabolized? 15 A No. 16 Q Do you have an opinion asto whether any of the 17 metabolites of vinyl chloride are themselves 18 carcinogenic? 19 A . No. 20 Q Do you have an opinion as to where in the human 21 body the metabolites of vinyl chloride might be 22 found? 23 A No. 24 Q As anepidemioligist I take it you'vestudied a W H iiy n _________________ IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E______________ Boston, Massachusetts 02110 (617) 367-8888 _ 43 1 number of chemicals suspected or proven to cause 2 cancer in humans? 3 A I've studied groups of people who were exposed to | I 4 chemicals. j 5 Q Do you know anything about chloro ethylene oxide? 6 A I don't believe so unless it has another name. 7 Chloro ethylene oxide? 8 Q Yes, sir, 9 A No, I don' t . j i 10 Q Have you reviewed any studies prior to today that 11 indicate whether or not chloro ethylene oxide is a| 12 metabolite of vinyl chloride? 13 A I don't recall that I have. 14 Q Do you have an opinion today as to whether or not 15 vinyl chloride is a human carcinogen? 16 A I think my opinion about the studies for the last j 17 15 years are that people who work at vinyl j IB chloride plants who have excess cancer, excess 19 angiosarcoma -- I'm trying to phrase it in a way 20 of how I think or what I think causes might be. 21 If I say a chemical is a cause, if I 22 say in my opinion vinyl chloride causes 23 angiosarcoma, part of that could be that a 24 znatabolite of it is also a cause. URL ^ 14'd5 IRENE M. ARA3IAN, CSR/RPR 65 East India Row. Suite 20-E__________________________ Boston, Massachusetts 02110 (617) 367-88C8 URL 11496 i. 44 1 Q Then let's talk about vinyl chloride and it's 2 metabolites. 3 A It's implicit that if vinyl chloride is -- well,` 4 put it another way. If a metabolite of vinyl 5 chloride is a cause then vinyl chloride itself is 6 the cause. 7 Q With that assumption in operation do you have an 3 opinion today as to whether vinyl chloride is a 9 human carcinogen? 10 A Yes. 11 0 What is your opinion? 12 A My opinion it is. 13 Q Do you have an opinion today as to whether vinyl 14 chloride is a human mutagen? 15 A Ho, I don 1t. 16 Q Do you have an opinion today as to whether or not 17 vinyl chloride is a human teratogen? 18 A Ho, no, 1 have no opinion. 19 Q Had the CMA come to you not in 1973 but in 1953 20 and asked you for a proposal to study vinyl 21 chloride carcinogenicity, would you have been able 22 to do and to propose the same type of study that 23 you proposed to the CMA in 1973? 24 A You mean knowing what I knew in 1974 about IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E______________________________________ Boston, Massachusetts 02110 (617) 367-8885  45 1 epidemiology? 2 Q Yes. 3 A In 1963 I knew nothing about epidemiology. j 4 Q Let's talk about the field of epidemiology rather 5 than you personally. 6 A All right. e 7 0 Would the field of epidemiology have been able tc 8 do and propose to the CMA had they been requested 9 to do so in 1963 precisely the same study that you: 10 proposed doing for the CMA when it contacted you 11 in 1973? 12 A I would say generally, yes. 13 0 Do you have an opinion as to whether vinyl 14 chloride or its metabolites are excreted from the 15 body? 16 A Yes, I assume they are excreted. 17 0 In the urine or the feces or both? 10 A I have no opinion. 19 Q Do you intend to express an opinion in this case 20 as to the role, if any, which vinyl chloride 21 played in the cancers that killed Herman Dendingsr 22 and Fred Wallace? 23 MR. BUNDAs I'm going to object to the 24 form of the question. I don't know that the IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 3 67-8 8 8 C URL 1149? 46 doctor has an intention to express any opinion except to answer the questions that are put to him MR. DELLI BOVI: I will reask the question then. Q Do you have an opinion today as to whether vinyl chloride played any role in the cancers that hilled Herman Dendinger and Fred Wallace? A Do I have an opinion? Q Yes. A Yes, I have an opinion. Q What is your opinion? A I think it ` s very unlikely that vinyl chloride? had a role in either of their cancers. Q What is the basis for your opinion? A The sum of the epidemiologic evidence on the studies of vinyl chloride workers. 0 Is colon cancer a common type of cancer? A Yes. Q Among what particular age groups is it most common? A I can't be as specific but in general it's more common. Well, certainly more common among older people than younger people. Whether it becomes URL 11498 IRENE M. ARABIAN, CSR/RPR _______________________65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 ___________________ J URL 11499 47. 1 less common in very old people I don't know. 2 MR. BUMDA: If we could stop for just 3 a second. Let's go off the record. 4 (Discussion held off the record.) 5 0 From an epidemiolgic prospective is it easier to 6 establish causal connections or possible causal 7 connections between an exposure to a potential 8 carcinogen and the development of that carcinogen 9 if the cancer is a rare one? 10 A I don't think being rare by itself necessarily 11 makes it easier to identify a cause. 1 2 Q Does the degree to which a chemical causes an 13 increase in the rate of particular cancer affect 14 an epidemiologist's ability to discover that 15 causal connection depending on whether or not the i j 16 cancer is a rare one? 17 A Again, I'm not sure what you mean by "degree." 13 C Okay. VJhat I'm trying to contrast, for example, 19 is a chemical that causes a 5 percent increase in 5 20 lung cancer rates as opposed to a chemical that 21 causes a 5 percent increase in thyroid cancers. 22 Is it easier to detect that increase when you're 23 dealing with a rare form of cancer than it is a 24 common type of cancer? IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 URL 11500 48 1 A I don't have an opinion that it is. I think in 2 certain contexts one might want to make 3 arguments -- 5 percent of course is a very small 4 increase* I don't think any epidemiologic study 5 can detect 5 percent. You could have used another 6 number but -7 Q What percentage increase do you feel it would 8 require in order for the field of epidemiology to B take note of a potential causal connection? 10 A Oh, I would say somewhere between 20 and 40 is 11 where you start being able to collect data that 12 are stable. 13 0 Now at the 20 to 40 percent level will that allow 14 you as an epidemiologist to draw any conclusion:, 15 with statistical significance or would you need 16 increases in cancer rates even higher than that? 17 A IJo. You can get statistical significance at any 18 rate depending upon the amount of data you have. 19 Q And the amount of the data is directly 20 proportional to the number of individuals in the 21 cohort ? 22 A Partially that, yes. 23 0 Have you attempted in your review of the 24 literature that you reported to Mr. Bunda on *' IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 2 0-E Boston, Massachusetts 02110 (617) 367-8888 49 1 March 24, 1968 and October 6, 1988, to select out 2 those studies that dealt with workers in the PVC 3 fabrication industry as opposed to workers in the 4 VC or PVC manufacturing industry? 5 A I'm sorry, have I done what? 6 Q Attempted to select out those articles or studies 7 that dealt with PVC fabrication employees as 8 opposed to vinyl chloride monomer rrtanufacturinc; orj | 9 PVC resin manufacturing employees? j 10 A I'd have to look and see. 11 rW\ My question is whether in terms of your analysis i 12 and in terms of your opinions concerning causation' 13 you've attempted to segregate out from all of the 14 studies you've reviewed those that deal with PVC URL 11501 15 fabrication industry employees? 16 A Yes, the bulk of them were PVC fabrication. PVC 17 fabrication means making PVC from VCr is that 18 correct? Most of the studies are of that sort of 19 study. 20 Q My question remains the same. Dr. Konson, is that 21 whether you attempted to segregate out and to 22 separately analyze the studies of PVC fabrication 23 employees versus studies that dealt with PVC 24 manufacturing or vinyl chloride monomer i IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E________________;________ Boston, Massachusetts 02110 (617) 367-8888 50 1 manufacturing employees? 2 MR, BUNDA: Doctor, when he uses PVC 3 fabrication he means taking the resin and making 4 plastic products out of it as opposed to somebody 5 making the PVC. 6 A I wasn't sure about your -- I mean there's a study 7 which is what I would call fabricators taking PVC 8 resin and making something out of it. And most of 9 the other studies are making PVC from vinyl 10 chloride monomer, that's the way I think of it. | 11 C Are there any principal studies of PVC fabrication 12 employees you are familiar with other than URL 11SO 13 Chiazze's and Dr. Shindell's? 14 A In terms of studies? I'm not aware of any other ro 15 studies. My memory may be incorrect, it may be 16 faulty. 17 0 Is there any reason why you haven't attempted to ie segregate out and to separately analyze the PVC 19 fabrication employee studies? 20 A well, I have in the sense that I've looked at 21 Chiazze's that's separated from the VCM studies. 22 Q Have you reviewed Dr. Shindell's study? 23 A I've reviewed the report in here which is Shindell 24 and/or Ulrich's epidemiologic study. IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E__________________________ Boston, Massachusetts 02110 (617) 367-8888 51 1 Q Have you ever reviewed before today or asked for 2 or been furnished with any of Dr* Shindell's raw 3 data? 4 A Ho. 5 Q When you did your epidemiologic studies of the 6 rubber worker employees* did you use a two-year 7 minimum employment cutoff? 8 A Initially it was five years and then the follow-up 9 wa s two years. 1C 0 What was your reason for using initially a 11 five-year and later a two-year minimum employment 12 threshold if I can call it that? 13 A Basically ease of finding employees who had 14 terminated. 15 0 Any other reasons? 16 A Hot that I can think of* I think it was just a 17 matter of we felt that short-term workers would bej 13 hard to trace. 19 Q Do you have an opinion as to whether the 20 incorporation into an epidemiologic study dealing 21 with occupational exposures and cancers of j 22 employees with a total employment period in the 23 effective industry of three months would have the 24 effect of diluting the results of the study? _________________ IRENE M. ARABIAN* CSR/RPR 65 East India Row* Suite 20-E Boston* Massachusetts 02110 (617) 367-8888 i. 52 A I think what you want to do is stratify years worked, length of work and split your group into people who have worked varying lengths of time. Q When you did the study of the rubber workers what did you use as the employment cutoff date, was there a period of time prior to the start-up of your study after which you no longer would consider a particular employee? A I'm sure there was. I don't recall but my guess it was was five years before -- well, in the initial study if we took only workers who had worked at least five years we started in 1940, then anyone who started working after 1935 would not have been included. That's my recollection but I I may be wrong. Q Do you have an opinion as to the latency period for cancers caused by vinyl chloride exposure? A I don't have a number in my mind that I think is critical. Q Do you have a range and you can answer it either way you want, with respect to vinyl chloride cancers or occupational cancers in general? MR. BUNDAs I'm going to object to the Question "occupational cancers" with respect to IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E____________________________________ Boston. Massachusetts 02110 (617) 367-8889 URL 11504 53 1 the fact that it's vague and over broad and 2 therefore irrelevant* 3 Q You can go ahead and answer. Doctor* 4 A I'm trying to think of the various circumstance:. 5 One can consider radiation as an occupational 6 exposure in some sense and radiation I think one 7 can see cancers say five to 15 years or more R commonly 15 to 25. Q With chemicals there 3ro certainly a 10 range, I don't have anything specific in mind. 11 The vinyl chloride I don't have a number in mind 12 as to the minimum years latency bu t there is s o ;Vi o 13 number that I would look at. I don ' t have a 33 r-- 14 number i n my mind. That 1 s the answe * 1 5 Q Talking about chemically induced occupational on O on 16 cancers, do you have a general number or a general. i 17 range in mind in terms of minimum latency periods? IP HR. BUNDA: Same objection* X think 19 it's vague, over broad and irrelevant* i 20 A I don't keep firm numbers in my mind. I can say 21 what other people have done, I*m not sure if that j 22 is relevant* 23 Q Do you have an opinion based on the readings of 24 others that you have reviewed concerning the I __________________ IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 54 1 latency period for occupationally induced vinyl 2 chloride cancers? 3 MR, BUNDA: Same objection, 4 A. I just don't have a number in my mind. I would 5 want to go through the papers and come up with a number to answer the question in a reasonable way. 7 I don't have a number that I have arrived at that e I carry around with me. 9 Q Would you take a look at Dr. Shindell's study if 10 you have a copy of that with you. Did 11 Dr. Shindell attempt to determine the SMRc for 12 colon cancers or parotid gland cancers or buccal 13 cavity and pharyngeal cancers? 14 A Table III. Yes. I don't know what he tried to 15 do. I can only say what's in the paper. 16 0 Does the paper report any SMRs for colon cancer or 17 parotid gland cancer or buccal cavity and 1C pharyngeal cancers? 19 A I*m trying to understand what's in Table II here, 20 what it says. I don't think that he has SMRs. 21 All he has listed here is respiratory cancer and 22 other cancer. In the text he may have had 23 specific ones. 24 0 Have you at any time attempted to utilize sos i n u n IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 f 6 17 ) 367-8888 ___________ <M Hsu? 55 1 Dr. Shindell's report to determine the SMRs for 2 colon cancer and parotid gland cancer at the 3 Chrysler facility? 4 A No. 5 Q Would that be something that an epidemiologist | j i 6 would ordinarily do to determine whether there was 7 an increase in the observed number of colon cancer 8 deaths and parotid gland cancer deaths versus the 9 number expected? 1 0 A Would one compute an SNR, is that what you're 11 asking? 12 Q Yes, Doctor. 13 A That's part of the exercise,yes. 14 0 Do you see anything in Dr. Shindell's report that 15 does that? 16 A As I say I don't see anything in the tables. 17 There may be something in the text. i | j 18 0 Have you read the text before today? 19 A Yes. 20 Q Do you recall -- j j 21 A I don't recall that he did but X can't say that hej i 22 didn't. 23 Q Can you refer back to Table II, I believe it was, 24 if that was the one you were on before. Do you IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E_______________________________________ Boeton, Massachusetts 02110 (617) 367-8888 ' M 11508 L 56 1 know in which of the job categories reported in 2 that table Mr* Wallace and Mr. Dendinger worked? 3 A I don't have it in my mind, no. 4 Q Have you attempted prior to today to determine the 5 total number of cancer deaths in the job 6 categories in which Mr. Wallace and Mr. Dendinger 7 were employed? 8 A no. 9 Q Have you been furnished with any data. Dr. Monson, 10 prior to today that leads you to believe that 11 Mr. Dendinger or Mr. Wallace were occupationally 12 exposed to any carcinogens other than vinyl 13 chloride? 14 A I have the two industrial commission reportshere. 15 In Wallace it says was handling many different 1 S aromatic and abrasive compounds. I don't know 17 what they were. So some of those could be 10 carcinogens 19 In Dendinger it says was exposed to 20 pigments which contained other substances and then 21 three of them are methyl ethyl ketone, 22 tetrahydrofuran and toluene. 23 And then it also says the patient 24 claims that the malignant tumors were caused by IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 URL 11509 571 contlnuous repeated overexposure to polyvinyl 2 chloride, toxic solvents and other carcinogenic 3 substances. That's basically what I've been 4 given. 5 Q Based on the materials that you've been given, do 6 you have an opinion with reasonable professional 7 certainty as to whether Dendinger or Wallace were 8 occupationally exposed to carcinogens other than o vinyl chloride? 10 A I don't have an opinion other than what I juct 11 said. 12 Q Would you take a look. Doctor, at Table XI, I 13 believe it is, to Dr. Shindell's study. I'd like 14 you to assume for the purposes of the next few 15 questions that Mr. V.'allace was classified by 16 Dr. Shindell as working in the coating/finishinc 17 department and that Mr. Dendinger was classified 13 by Dr. Shindell as working in the 19 inspection/shipping department. Okay, can you 20 assume that for me? 21 A Yes. 22 Q booking at the respiratory cancer deaths in the 23 two departments in which Mr. Wallace and 24 Mr. Dendinger worked, what was the number of IRENE M. ARABIAN, CSR/RPR ______________________65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 _____________________ UhL 11510 SB 1 expected deaths and what was the total number of 2 observed deaths? 3 A Coating and finishing the expected is 1.4 and the 4 observed is four. Inspection/shipping the 5 expected is 1.17 and the observed is two. 6 Q So in terms of respiratory cancer deaths in the 7 job categories in which Wallace and Dendinger S worked the expected number of deaths were 2.57? Q A Do you want me to calculate it or I'll accept your 10 ratio. 11 0 And the observed number of deaths were six? 12 A Yes. 13 Q Do you have an opinion as to whether or not 14 exposure to vinyl chloride causes lung cancer? 15 A I don't have a firm opinion, no. 16 0 Would the figures reported by Dr.Shindell of his 17 epidemiologic study of the workers at Chrysler and IS in particular the job categories Mr. Wallace and 19 Mr. Dendinger worked, support the hypothesis that 20 exposure to vinyl chloride causes lung cancer in 21 your opinion? 22 A One would want to look at it in the context of all 23 cancers. One wouldn't want to just pick up one 24 cancer. IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 2 0 - E Boston, Massachusetts 02110 (617) 367-8888 59 1 Q Why would you want to look at it in the context of 2 all cancers? 3 A Because the hallmark of vinyl chloride related 4 cancer is angiosarcoma. 5 Q Are you familiar with studies of workersin the 6 ` PVC fabrication, PVC resin manufacturingand vinyl 7 chloride resin manufacturing industries that 8 showed no incident of angiosarcoma at all? 9 A Again, I didn't follow the question of the three. 10 Q Are you aware of studies in the PVC fabrication 11 industry? 1 12 A Do you mean PVC manufacturing? tS 13 0 PVC fabriCuting. 14 A That's what I'm not following. You mean _ .a 15 fabricating is making? 16 Q We've been using fabrication in the context of \I j 17 this case to refer to a company that purchases the IE manufactured PVC resin and then makes something 19 out of it. 20 A Okay, fine, fine. j 21 Q Are you aware of studies in the PVC fabricating, 22 PVC manufacturing and VC manufacturing industriei 23 that report no angiosarcoma deaths? 24 A Just to be clear I'm aware of studies in PVC IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-88B8 l l ItiU 60 1 manufacturing that is where they do the 2 polymerization. I think there are studies where 3 there is no angiosarcoma deaths. 4 Q Is it your opinion that the existence of those 5 studies detracts from the results reached in other * 6 studies showing a relationship between vinyl 7 chloride exposure and angiosarcoma of the liver? 8 A No. 9 0 In terms of lung cancer deaths at the Chrysler 10 facility, do the number of actual deaths exceed 1 1 the number of expected deaths by over 100 percent? 12 A Yes. 13 Q Now id like you to take a look next at the other 14 cancer deaths in the job categories in which 15 Wallace and Dendinger worked. Have you attempted 16 prior to today to segregate out and to separately 17 analyze those job categories in which the 18 plaintiffs, decedents in this case, worked for 19 cancer deaths? 20 A I look atTable III which hasobserved numbers 21 described by the specific causes, that's all I've 22 done 23 Q You haven't attempted though before today to break 24 out of the data from the job categories in which IRENE M. ARABIAN, CSR/RPR 65 Ea3t India Row, Suite 20-E___________________________________ Boston, Massachusetts 02110 (617) 367-8886 61 1 Wallace and Dendinger were placed? 2 A No. 3 Q I*d like you to take a look. Doctor, at the other 4 cancers reported in Table II for the 5 coating/finishing and inspection/shipping job 6 categories. If we total those do those show 7 expected deaths of 4.42? 8 A Yes. 9 Q Ana observed deaths of eight? 10 A Right. 11 Q Finally, if we look to the total number of cancer 12 deaths in the job categories in which Wallace and 13 Dendinger worked, and you may want to use your t5 r* 1 4 calculator on this, would we expect a total of ,,,n 15 6.99 cancer deaths? 16 A Yes, that seems about right. 17 0 And the total number of observed cancer deaths v?as! j 18 double the total number expected? i 19 A It's 14, yes. 20 Q Have you seen any study, epidemiologic study of ii 21 the vinyl chloride monomer manufacturing industry,j 22 the PVC manufacturing industry or the PVC 23 fabrication industry where the total number of 24 observed cancer deaths for the entire work force IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 Hsm un 62 1 or any segment of the work force is more than 2 double the total number of expected deaths? 3 A What you are taking out of here though is you're 4 breaking the study apart so I'm not sure it's a 5 re1eva n t comparison* 6 Q Okay* Would it make sense to you if we're 7 analyzing and attempting to determine the cause of 8 Wallace and Dendigner's cancer to look to tho 9 particular job classifications in which those 10 employees worked? 11 A What I'm thinking is -- let me think about it a 12 minute. Certainly looking at what they worked 13 with is relevant, yes. 14 Q So you know from the results of Dr. Shindell's 15 study that the total number of observed deaths in 16 the job categories in which Wallace and Dendinger 17 were assigned were double the number of expected 18 cancer deaths? 19 A Yes. 20 Q Have you read, prior to today, Dr. Shindell's 21 deposit ion? 22 A No. 23 Q If you were the researcher who uncovered, as a 24 result of an epidemiologic study, results showing IRENE M. ARABIAN, CSR/RPR ______________________ 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 n iy r 63 1 in this case observed cancer deaths in the job 2 categories Wallace and Dendinger worked double the 3 expected number of cancer deaths what would you 4 want to do next? 5 A Well, one thing is to look at the specific causer: 6 of cancer. Another thing would be to characterize 7 the work place where they worked. Then try to 8 relate the specific causes to the work place 9 -0 10 Q Would another thing you might want to do be to 11 look at the individuals themselves to see whether j their work historys or their medical historys werej 12 13 consistent with an occupational exposure, whether } ! 14 the latency period between beginning employment j j15 and the development of cancers fit into accepted 16 ranges? i i 17 MR. BUNDAs I'm going to object to the! l 18 form of the question. I don't think the question 19 makes any sense, it's vague and ambiguous. i 20 You're switching terms. I think your 21 question describes occupational exposures and I i 22 think what you're implying by the question is an 23 occupational cause of the cancer so I'm going to 24 object to the question as being vague and IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-B______________________________________ Boston, Massachusetts 02110 (617) 367-8888 64 1 ambiguous. 2 Q You can go ahead and answer, 3A I think one would want to see if there is an . 4 inconsistency with what they were exposed to. 5 Q Would you as an epidemiologist with that data in 6 front of you want to do more? 7 MR. BUHDA: More what? 8 Q Research in an attempt to determine the cause or 5 the potential cause of the increased observed 10 number of cancer deaths versus the expected number 11 of cancer deaths. 12 A Looking at the study these excesses are based on 13 fairly small numbers so it's not clear-cut what 14 the next step should be. Most epidemiologists 15 would say it's useful to continue following the 16 group of people. 17 X think another thing that would be 18 useful to do is to try to characterize the 19 exposure patterns within these various groups and 20 specify what or in fact measure what levels of 21 exposure there has been in the past and at the 22 present 23 Q And is that what you would recommend to whoever 24 commissioned you to perforin that type of a study? URL 11516 _________________ IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E___ Boston, Massachusetts 02110 (617) 367-8888 URL 11517 1 A Yes. 6'5 2 O Do you have an opinion* Dr. Monson, as to what 3 caused Mr. Dendinger's colon cancer or 4 Mr. Wallace's parotid gland cancer? 5 A NO. 6 Q Do you have an opinion as to the way in which 7 vinyl chloride or its metabolites can cause S cancers or may cause cancers other than 9 angiosarcomas of the liver? 10 A No. 11 Q Do you have an opinion today as to the reason why 12 the observed number of cancer deaths in the job 13 categories in which Wallace and Dendinger worked 14 is double the number of expected cancer deaths? 15 A No. 1G Q Do you know who commissioned Dr. Shindell's study? 17 A I could look through it and see, it says in the 18 report. 19 Q Do you have an opinion as to when one considers i i 20 epidemiologic studies done by others one has to 21 take into account the possible bias of the 22 inve stigator? 23 A I think in general one looks to seewhere studies 24 come from but I don't think that I feel that there IRENE M. ARABIAN. CSR/RPR 65 East India Row, Suite 20-E Boston. Massachusetts 02110 (617) 367-8888 66 is necessarily bias based on who supported tho study, Q Have you made any attempt prior to today to determine where Dr. Shindell's study came from? A As I say I assumed it was -- I'm just trying to think what conversations I've had. The study was initiated because Chrysler and a number of suppliers of material: used in the plant were interested in determining whether workers at the Sandusky plant had experienced any unusual mortality as compared.to comparable segments of the general population over the same period of time. So I infer from that that Chrysler and the suppliers of materials commissioned the study. r=' Q Would you define the term "observation bias," please? C--O A Do you have my book? | Q I have an article that you wrote in 19 -- A *78 probably. Q -- *78 called "Effects of Industrial Environment on Health." A In my book I define observation bias -- I'm just trying to make a general, see if I can come up IRENE M. ARA3IAN, CSR/RPR 65 East India Row. Suite 2 0 - E_________________________________ Boston, Massachusetts 02110 (617) 367-8888 67 1 with some general words that I use. 2 Let me put it in the context of when 3 obtaining information on disease, knowledge of 4 exposure will influence the categorization of 5 disease or vice versa. 6 Q Have you attempted to assess the role, if any, of 7 observation bias in Dr. Shindell's study? 8 A I think one observation bias is a matter of 9 opinion rather than a matter of one can't analyze 10 for it. 11 Q In your 1978 article, and if you'd like to look at 12 it I'd be glad to share it with you, did you 13 report that the risk of angiosarcoma among the 14 worker cohort study was more than 1000 times the 15 risk of that cancer among the unexposed 16 population? 17 A That seems more or less the basic data I had. 18 Q Do you have an opinion as to whether there is a 19 level of exposure to any carcinogen below which no 20 cancers will occur? 21 MR. BUNDA: Again, I'm going to object 22 to the form of the question on the basis that it's 23 over broad and vague. 24 Q Let's narrow it then to vinyl chloride. IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 URL 11519 o?s 11 itin i 6C 1 A Yes, I think at some very low level it's very 2 unlikely there would be any vinyl chloride caused 3 cancer. 4 0 Do you have an opinion as to what that level or 5 approximately what that level would be? 6 A I believe the current TLV is 1 part per million. 7 0 Is it your opinion, therefore, that the threshold B level for cancers is caused by vinyl chloride 9 would be at minimum 1 part per million? 10 A No. I think at minimum it would be above that by 11 a factor of 10 or 100. That is a TLV is said to 12 have some range of uncertainty. 13 0 In the conclusion of your article on "Effects of 14 Industrial Environment on Health," you indicate15 "There is no absolute process through which we can 16 learn whether a chemical causes a disease. 17 Different persons will collect, analyze and 13 interpret data differently. Errors will be made 19 which are not detected, conflicting results will 20 occur. In the face of such uncertainty, it seems 21 reasonable to err on the side of safety. If there 22 is a suggestion that a substance is carcinogenic, 23 it should be treated as such until further data 24 are available. Exposure to which should be IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E_________________________________ Boston, Massachusetts 02110 (617) 367-8888 URL 115 69 1 reduced period." 2 Was that your opinion with regard to 3 vinyl chloride at the time you wrote that article? 4 A Yes . 5 Q Is that your opinion with regard to vinyl chloride 6 today ? 7 A Yes. 8 Q Thank you. One of the articles that you brought 9 with you today was published this year in the 10 British Journal of Industrial Medicine by three 11 Soviet researchers, an article entitled 12 "Increasing Evidence of the Rise of Cancer in 13 Workers Exposed to Vinyl Chloride." 14 A Yes. 15 Q And do the results of that study report mortality j ! 16 for tumors of the digestive organs, respiratory j 17 system, bones and connective tissue, brain and | 18 skin greater than in the general population? 19 A Can I look at that table? 20 Q Sure. | 21 A Let's see, for men there is a deficit of digestive 22 cancer and for women the observed number is 23 greater than the expected. 24 Respiratory, there is no respiratory IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 70 1 cancer in women so that's a deficit . And in men 2 the observed is greater than the expected. 3 For bone it's hard to tell because 4 there is only one observed number. 5 Skin, again, there is only one 6 observed number so it's a little bit harder to 7 compute a number when the expected number isn't 8 given. 9 Brain, again, in men there is no 10 expected and in women there are two observed and 11 one expected. j 12 Q Do you have an opinion as to whether, by the time 13 Viola published in Cancer Research in 1971, vinyl 14 chloride was a suspected carcinogen? g r~ 15 A He reported that there were tumors of the zymbal r3 1G gland in animals so I assume he reported there 17 were carcinogens in rats. I'm not sure if he i 18 recorded liver cancer at that time as well or not.! I 19 0 Would you like to take a look at the summary of 20 the *71 article? 1 21 MR. BUNDA: The question related to 22 the time before the publication of the article or 23 at least before 1971 as I understood the question. i 24 The question as I recall it, was by IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-5. Boston, Massachusetts 02110 (617) 367-888E 71 1 the time Viola published in 1971 was vinyl 2 chloride recognized to be a suspected carcinogen 3 or something like that so I'm not sure that 4 reading from that particular article is going to 5 answer the question, 6 A I'm not sure what the term "suspected carcinogen" 1 means. They studied vinyl chloride for some 8 reason and whether it was because it was a 9 suspected carcinogen or some other reason I don't i 10 know. 11 Q My question is whether or not at the time that cXJ: 12 article was published in -13 A 71. crcono 14 Q -- in May of 1971, was there good scientific basis] i 1 5 for concluding that vinyl chloride was a suspected 1 5 carcinogen? 17 MR. BUNDAj I'm going to object to the lfl form of the question. I think he's indicated some 19 uncertainty about what you mean by "suspected 1 i 20 carcinogen." 21 Q If you can answer the question go ahead otherwise 22 I'll try to rephrase it. 23 A First of all this is an animal study. I'm not an 24 expert on animal studies. I didn't know the IRENE M. ARABIAN, CSR/RPR ____________65 East India Row. Suite 2 0-E_______________________ Boston, Massachusetts 02110 (617) 367-8888 72 1 status of animal literature at all before this was 2 published. I'm not an expert in the conduct of 3 research on animals so I don't know whether this 4 report itself was viewed by others as being a good 5 study or not so I just don't know. 0 Do you know whether it was as a result of the 7 publication of Dr. Viola's last work that the CMA B or the MCA, however it was known at the time, 9 contacted you in 1973? 10 A You know, there were two names that come to my 11 mind about vinyl chloride and animal cancer at the| 12 time. One was Viola and one ie Haltoni, I'n net 13 sure what was going on specifically. They 14 certainly both were involved in vinyl chloride in 15 rats. 1G Q By the time the MCA or the CMA contacted you in 17 1973, did that group indicate that it had reason 18 to believe that vinyl chloride was a cancinogen? 19 A As best I recall they said there were studies from 20 Italy saying that rats exposed to vinyl chloride 21 had cancers of the zymbal gland and the liver, 22 that's my recollection. So they reported the 23 facts, that's what I remember. 24 As an epidemiologist is it your opinion that it is IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E_________________________________ Boston, Massachusetts 02110 (617) 367-8888 URL 11524 URL 11525 T3 unethical to knowingly expose humans to suspected carcinogens? 3 A Again, it's a question of level of exposure. I 4 think everyone i6 exposed to substances that are 5 carcinogens at some level. You certainly don't e want to expose people to levels that have some 7 reasonable likelihood of causing cancer. 8 MR. DELL1 BOVI: Can we take a break 9 for about five minutes and then I think I can 10 probably wrap it up. 11 (Short recess.) 12 Q In formulating your opinions concerning the role 13 or the nonexistence of the role played by vinyl 14 chloride in the cancers Dendinger and Wallace 15 contracted, did you assume whether or not either 16 of those individuals was exposed to vinyl 17 chloride? 18 A I assume they were exposed to PVC raw material 19 whatever that's called, PVC pellets or however it 20 comes in. 21 Q Did you assume that they were or were not exposed 22 to vinyl chloride monomer? 23 A My understanding is that there is vinyl chloride 24 monomer trapped in pellets at some level. I don't IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 i have any idea as to how much. 74 0 Did you assume whether Dendinger and Wallace inhaled vinyl chloride monomer at their work # place? A. I didn't assume anything about that. Q So am I correct in understanding that you did not I assume for purposes of your opinion on causation that Wallace and Dendinger were in fact exposed to' and inhaled vinyl chloride monomer? 1 A I assumed there was vinyl chloride monomer in the j PVC monomer somehow. What happens to it aftc-r URL 11526 that I just don't know. They could have beer, exposed to it and they could not have been, I don't have any opinion one way or the other. 0 Did you make an assumption for purposes of ycur opinion on causation as to whether they did or clidj not inhale VC monomer? I A My assumption would be there was some VC monomer in the environment if in fact it was in the PVC. 0 Did you make an assumption as to whether or not they inhaled it? A If it's in air I assume they would inhale it, yes. Q In rendering your opinion on causation did you assume over what period of time Wallace and __65 East IRENE M. ARABIAN, CSR/RPR India Row, Suite 20-E__________________________________________ Boston, Massachusetts 02110 (617) 367-8888 1 5 1 Dendinger inhaled vinyl chloride monomer? 2 A I know they worked there for some number of years 3 but I don1t have that number in my mind. 4 Q Did you assume that they were constantly exposed 5 while at work to vinyl chloride monomer or that 6 they were exposed only during certain years or 7 only for portions of days or make any assumption 8 in that regard at all? 9 A I have no assumption as such other than what was 10 reported in there whatever this is, some of the 11 reports in here. As I say I don't recall having 12 assumed anything specifically about that. I can 13 make an opinion now but that's just an opinion. 14 0 Is it your opinion that the duration and intensity 15 of Wallace and Denaigner's exposure to vinyl 16 chloride are factors that must be considered in 17 determining causation? ro 18 A My assumption is that they were exposed to | I 19 relatively low levels throughout their work life ! 20 so that the intensity was below any reasonable | 21 likelihood intensity that would be -- well, it 22 would be considered as important. 23 Q Did you make any assumption concerning maximum or 24 peak levels of vinyl chloride that Wallace and "65 East IRENE M. ARABIAN, CSR/RPR India Row, Suite 20-E____________________________________ Boston, Massachusetts 02110 (617) 367-8888 1 Dendinger may have been exposed to? 76 2 A NO. 3 Q In your opinion in determining or rendering an 4 opinion on the issue of causation* should one take 5 into account the potential exposure peaks? 6 A I think it's hard in an individual. On an 7 individual person it's hard to determine causation 8 from that person's experience. One wants to look 9 at the scientific evidence that's available on 10 vinyl chloride exposure. 1 1 0 V7ac it your opinion or ic it your opinion that 12 vinyl chloride did not cause Dendinger's or URL 11528 13 Wallace's cancer because in your opinion the 14 literature that you have reviewed does not 15 establish a causal connection between vinyl 15 chloride exposure and colon cancer or parotid 17 gland or buccal and pharyngeal cancer? 18 A I think it's more the opposite, that the 19 literature provides fairly strong evidence against 20 such a hypothesis. 21 Q And was that the basis or is that the basis for 22 your opinion that Dendinger and Wallace's cancers 23 were not caused by vinyl chloride exposure? 24 A Yes. IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 URL 11529 77 1 Q Other than your papers dated March 24, 1988 and 2 October 6, 1988, have you authored any other 3 reports or letters or documents in this case that 4 set out any analyses done by you or any opinions 5 formulated by you? 6 A No. I've written letters about meetings and all 7 that but nothing about -- this is my scientific 8 contribution q 0 Have you met with anyone concerning this case 10 other than Mr. Bunda or a member of his firm? 11 MR* MONSON: The person we met with 12 last time was a person in your firm, right? 13 MR. BUNDA: Yes. 14 A No. 15 0 In terms of the literature that you have reviewed j / 15 and that is documented in your papers dated 17 March 24, and October 6, 1985, have you reviewed j 18 any additional epidemiologic literature on the 19 health effects of vinyl chloride other than those 20 reported in those two documents? 21 A I probably have* The issue would be whether other 22 reporte were epidemiologic or not* I've certainly 23 read other literature. Whether I would call then 24 epidemiologic or not is a fine point. IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E_______________________ Boston, Massachusetts 02110 (617) 367-8888 7C 1 0 Have you read any epidemiologic or reviewed any 2 epidemiologic studies on the health effects of 3 vinyl chloride other than those reported or 4 reviewed in your March 24 and October 6 documents? 5 A As I say I probably have. I can't give you a 6 specific one. 7 Q Is it correct that all of the studies which you 8 have reviewed were furnished to you by Mr. Bunda? Q A No. 1 0 Q May I take a look at this file, please? 11 A Yes. 12 0 There is a letter in this filedated March 27, 13 1988 from you to Mr. Bunda. It indicates in the 14 second sentence "I have reviewed only the 15 information contained in the folder provided by 16 you as well as reprints that I have collected 17 since 1974"i is that correct? 18 A Yes. 19 Q Now can you tell me which of the articles reviewed 20 by you in your March 24 and October 6 documents 21 were provided by Mr. Bunda and which you had in 22 your possession prior to that time? 23 A There is a considerableoverlap. Sothat most of 24 the ones -- most of the scientific articles he IRENE M. ARABIAN. CSR/RPR 65 Bast India Row. Suite 20-5 Boston, Massachusetts 02110 URL 11530 7 9/ 1 gave me I also had. The ones that 1 didn't have# 2 I didn't have the unpublished article by Jones. I 3 didn't have Doll's article, that was also 4 unpublished. I didn't have the Wong article 5 No. 13. 6 Q' Has the Jones article been published to date to 7 your knowledge? 8 A Yes. It's in the Scandinavian Journal of Work 9 Environment and Health. 10 0 Are there any opinions that you have concerning 11 the merits of this case other than those outlined 12 in your March 24 and October 6 documents and other 13 than those that we have discussed over the last 14 few hours? URL 11531 15 MR. BUKDAs I'm going to object to 16 that question on the basis that it's over broad 17 and incredibly vague. I'm sure the doctor has 18 additional opinions but his purpose here again is 19 to respond to questions. 20 MR. DELLI BOVIs Sure. What I want toj ! 21 understand is what Dr. Monson is going to be 22 testifying about in a few months when this case 23 comes to trial. The only materials I've been 24 furnished with concerning his opinions are these IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 8C 1 documents dated March 24 and October 6 and I want 2 to make sure that you're not going to offer 3 opinions on matters that are not contained in 4 those documents or that we haven't discussed over 5 the last few hours, * 6 MR, BUNDAj Well, I don't know that 7 you can do that. What I'm going to ask him is a 8 matter that I have yet to formulate. The doctor 9 will respond to whatever questions I ask if he's 10 qualified to do so. 11 I've given you come indication in rny URL 11 12 listing of witnesses that he's going to address 13 the causation issues from an epidemiologic CJ ro 14 standpoint. He's provided you with a report. I 1 5 provided you with his report which I wasn't 16 required to do. And I think that you're certainly 17 free to ask the doctor about the issues in the 18 case but to ask him a broad question like that 19 concerning opinions other than those already 20 touched upon I think is unfair so I'll object to 21 the form of the question. 22 0 Would you like to answer it for me. Doctor? 23 A I don't know how to answer it other than to say my 24 opinions are based on the scientific literature __65 East IRENE M. ARABIAN, CSR/RPR India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 82*. 1 and I'm not aware of any relevant scientific 2 literature to date that would expand upon my 3 opinions. 4 There are certainly other papers I've 5 read that are part of my opinions but I don't 6 think they add anything to what you have already, 7 MR. DELLI BOVI: That's all the 8 questions I have. 9 Doctor, thank you. 10 MR. BUNDA: Doctor, I have a couple of 11 questions. 1 2 Cross Examination 13 by Mr. Bunda 14 0 You were askedsome questions about a proposal 15 that you submitted to the Manufacturing Chemist 15 Association, do you recall that? 17 A Yes. 18 Q Do you recall whether or not you had any 19 information concerning why they wanted that study 20 done or what they were going to do with it after 21 they received the information? 22 A As I recall -23 MR. DELLI BOVI: I'm going to object 24 but you can go ahead and answer the question. IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 82 MR. BUNDA: What's the basis for your obj ection? 3 MR. DELLI BOVIs Hearsay. 4 Q All right. Go ahead, Doctor. 5 A They wanted to do a Btudy so that they could 6 report the results at the next International 7 Cancer Conference. 8 Q And do you have a belief in your own mind as to 9 why they chose the Tabershaw group to do the study; 10 rather than accepting your proposal? i 11 A I don't have a specific belief other than 1 thin;: | I 12 Tabershaw was an experienced occupational health ! 13 professional and they probably knew him better 14 than they knew me, c 15 Q Did the type of study that was being proposed by :i Cw' 16 Tabershaw versus the type being proposed by you 17 have any factor in your own mind with regard to 18 which study was accepted? 19 A We both proposed essentially the same study. 20 Q What kind of study was that? 21 A Well, I proposed a retrospective cohort study but 22 also a proportional mortality study. Tabershaw 23 proposed only a retrospective cohort study but 24 basically the same approachl IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 83. 1 Q What is the length of time required for each of 2 those? 3 A I proposed a proportional mortality study because 4 it would take less time than a retrospective 5 cohort study. At that time my estimation was a 6 retrospective cohort study would take a year and a 7 half or two years and a proportional mortality 8 study would take maybe six months. URL 11535 9 0 In terms of obtaining accurate information 10 regarding causation which is the better study? 11 A The retrospective cohort study. 12 MR. BUNDA: I think that's all I have, 13 Redirect Examination j 14 by_D e 1_1_ i^B ov^i j 15 Q I hand you a document that's previosly been marked' i IS plaintiffs' Exhibit Peterson 1# have you ever seen! i 17 that document before? 18 A I don't believe I've seen it. 19 Q Other than the medical and scientific journal i 20 articles that you've brought with you today and 21 the other medical and scientific journal articles 22 you have reviewed, have you been furnished with or 23 reviewed any other documents in this case other 24 than a binder of materials captioned IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 X 84 1 "Wallace/Dendlnger litigation materials" and 2 containing 26 items? * 3 MR, BUNDAs I*m sorry, what was the 4 question? Have you been furnished with -- 5 MR. DELLI BOVIs Has he been furnished 6 with or reviewed anything else. 7 A I've reviewed this binder. 8 Q Containing the 26 items of materials? 9 A Right. I've reviewed the papers that I gave you, 10 that were given to you by Mr* Sunda and I've 11 reviewed a number of other scientific papers on 12 vinyl chloride that were primarily not 13 epidemiologic case reports and a variety of 14 things 15 Q So other than the scientific and medical articles 16 you have reviewed, the only other documentation 17 you've reviewed in connection with this care is cr 3D 18 the binder of Wallace/Dendlnger litigation 19 materials containing 26 items? 20 A And I've Been two depositions. 21 0 What depositions have you seen? 22 A Doll and Jones. Is Jones the other person? 23 MR. BUNDAs Kelly. 24 .A Kelly. IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 2 0-E Boston, Massachusetts 02110 (617) 367-8888 URL 11537 84 MR. DELLI BOVIs That's all I have. I do have one other thing* Q Would you provide Mr* Bunda with a copy of your 1973 proposal to the MCA or the CMA within the next week? A Right. MR. BUNDA: Again, I would ask that you - MR. DELLI BOVI: I would formally request that from you. MR. BUNDA: All right. Recross Examination by_Mr_j__Bunda 0 Dr. Monson, just so the record is clear, when you were asked about the material that you reviewed you referred to the binder and you referred to articles that I then supplied to plaintiffs' counsel. Where did those articles that were supplied come from? A I gave them to you. Q They came from your own files? A Yes. Q Thank you. Those were your own records? A Yes. IRENE M. ARABIAN,CSR/RPR 65 East India Row. Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 86 1 Q Those were kept before this case ever arose: " 2 A Yes. 3 MR. BUNDA: That's all. X have no A further questions. 5 (VJhereupon, the deposition 6 was concluded at 2*45 p.m.) 7 8 9 10 11 12 13 14 15 16 17 10 19 20 21 22 23 24 IRENE M. ARABIAN, CSR/RPR 65 East India Row, Suite 20-E Boston, Massachusetts 02110 (617) 367-8888 URL 11538 87 1 C ,_E_R_T_I_F_I_C_A T E 2 COMMONWEALTH OF MASSACHUSETTS ) ) 8S 3 COUNTY OF SUFFOLK ) 4 I, Wendy Wagner, a Registered Professional 5 Reporter, a Notary Public within and for the 6 Commonwealth of Massachusetts, do hereby certify: 7 That Richard R. Monson, M.D., Sc.D., the witness 8 whose deposition is hereinbefore set forth# was duly 9 sworn by me and that such deposition is a true record 10 of the testimony given by said witness, 11 I further certify that I am not related to any of 12 the parties to this action by blood or marriage, and 13 that I am in no way interested in the outcome of this 14 matter. 15 Ill WITNESS WHEREOF, I have hereunto set my hand 16 and affixed my seal of office this 24th day of October 17 1988. 18 19 Wendy Wagner 20 21 22 My Commission expires: 23 June 18, 1994. 24 i t Tcii'i IRENE M. ARABIAN, CSR/RPR 65 East India Row. Suite 20-E Boston, Massachusetts 02110 (617) 367-8888