Document 06m9GqRJLYEmx5mxmaq6QBZen

l 1 jnitho states district COURT FOR THE DISTRICT OF JERSEY 2 3 GRACE M. GRASSO, EXECUTRIX OF THE 4 ESTATE OF JOHN C. S3ASS 0, DECEASED, 5 PLAINTIFF, -- v-- 6 3.F. GOODRICH COMPANY. 7 DEFENDANT. 8 DOCXET NU-WRER 7 -1 5 A 2 9 10 3EF0RE 11 THE H0NGRA3LE STANLEY S.630TRAN, UNITED STATES DISTRICT JuDGE 12 date: Thursday, January 22, ic?l 13 14 APPEARANCES : 15 16 MESSRS. 3 R 0 W N , CONNERY, <ULP, WILLS, PURNELL AND GREENE, 17 3Y: MICHAEL J. VA S S ALOT YI, ESC tJ IRE, ATTORNEYS FOR THE L-' I NT I ep . 18 19 MESSRS. SC'-MJENE"AN\* AND G E R C < E 20 3Y: STEPHEN DUMSSR, ESOulRE, 21 22 23 24 LEGAL SUPPORT SERVICES 25 1400 David Stott Duilding Detroit, Michigan 48226 965-5445 ASI-PR 0004307 S zXA.-l 1 NAT 1 ON - LAUCI'JS - MR . RENNSI5SN S5 1 The JURY PRESENT.) 2 THE COURT : CALL YOUR NEXT 3 WITNESS. 4 MR. VASSALOTTI:. THANK YOU, 5 YOUR HONOR. DOCTOR SAMUEL EPSTEIN. 6 SAMUEL EPSTEIN SWORN. 7 DIRECT EXAMINATION BY MR. VASSALOTTI. 8 0. DOCTOR, 8 Y WHOM ARE YOU PRESENTLY 9 EMPLOYED? 10 A. THE UNIVERSITY Or ILLINOIS MEDICAL 11 CENTER IN CHICAGO. 12 Q . AND WHAT IS YOUR POSITION WITH THE 13 UNIVERSITY OF ILLINOIS MEDICAL CENTER? 14 A. I'M PROFESSOR OF OCCdPATIONAL'AND 15 ENVI.RGMENTAL MEDICINE. 16 Q. CAN YOU DESCRIBE THE AREA OF 17 MEDICINE AND/OR TOXICOLOGY THAT YOU ARE 18 INVOLVED WITH IN THAT POSITION? 19 A.. MY MAJOR PROFESSIONAL INTERESTS 20 RELATING TO THE TOXICS ANO CANCER CAUSING OR 21 CARCINOGENIC EFFECTS OF CHEMICALS IN THE 22 ENVIRONMENT WITH PARTICULAR REFERENCE TO 23 POLLUTANTS IN AIR, FOOD, WATER AND THE WORK 24 PLACE. YOU ARE A MEDICAL DOCTOR? ASI"PR 0004308 XA.MINATI3N - SAMUEL EPSTEIN - MR. VASSAL07TISS A. I AM. 0. COULD YOU GIVE US A SUMMARY OF YO'JR EDUCATIONAL BACKGROUND IN THE MEDICAL FIELD? A. . I GRADUATED IN .MEDICINE IN LONDON IN 1950/ HAVING OUALIFIED BEFORE THAT AS A PHYSIOLOGIST. I SPENT SEVERAL YEARS IN THE ARMY AS A PATHOLOGIST. I THEN WORKED IN LONDON UNIVERSITY TEACHING MEDICINE, PATHOLOGY AND TOXICOLOGY AND ALSO DOING RESEARCH IN AREAS OF CANCER. I CAME TO THIS COUNTRY IN 1950 TO HAVARD AND WORKED AT THE CHILDREN'S CANCER RESEARCH FOUNDATION IN BOSTON ON PROBLEMS OF ENVIROMENTAL TOXICOLOGY: THAT IS AG4TN THE TOXIC EFFECT OF CHEMICALS IN AIR, FOOD AND WATER AND WAS ALSO A PATHOLOGIST AT HARVARD MEDICAL SCHOOL. I WENT TO CASE WESTERN RESERVE MEDICAL SCHOOL IN CLEVELAND WHERE I HAD A CHAIR. IN HUMAN ECOLOGY AND MOVED TO CHICAGO IN 1975. Q. AND THAT IS WHERE YOU WORK NOW, IN CHICAGO? A. THAT IS CORRECT. Q. DOCTOR, HAVE YOU RECEIVED ANY AWARDS FOR YOUR MEDICAL OR RESEARCH WORK? ASI-PR 0004309 DIRECT EXAM I NAT I ON SAMUEL EPSTEIN - M P VAS5ALOTTIR7 1 A. TE5. I RECEIVED A VARIETY AWARDS IN 2 THE WORLD ARMY MEDICAL CORP. 3 Q. THAT'S IS IN THE BRITISH ARMY? 4 A. 3RITISH ARMY. I'VE ALSO RECEIVED 5 SOCIETY OF TOXICOLOGY. IT*S AN AWARD IN THIS 6 COUNTRY IN 1959, SOCIETY -- SOCIETY OF 7 TOXICOLOGY ACHIEVEMENT AWARD AND A VARIETY 8 OTHER PROFESSIONAL SCHOLARSHIP AND 9 DISTINCTION. 10 Q. WHAT IS TOXICOLOGY? 11 A. TOXICOLOGY IS THE SCIENCE OF ADVERSE 12 EFFECTS, THE STUDY OF ADVERSE EFFECTS 13 GENERALLY IN RELATION TO THE EFFECTS OF 14 CHEMI CALS. 15 Q. AND YOU MENTIONED THAT YOUR PRIMARY 16 INTERESTS AS A PHYSICIAN WAS STUDYING THE 17 TOXIC AND CANCER CAUSING EFFECTS OF CHEMICALS 18 IN THE ENVIRONMENT? 19 A. THAT IS CORRECT. 20 0. ANO IN THE WORK PLACE AS WELL? 21 A. YES. 22 Q. DOCTOR, HAVE YOU SERVED ON ANY 23 GOVERNMENT COMMITTEES OR WORKED WITH ANY 14 GOVERNMENT AGENCIES AS A CONSULTANT OR ACTED 25 AS A CONSULTANT TO ANY OTHER ORGANIZATIONS ASI-PR 0004310 EXAMINATION - SAMUEL EPSTEIN - M3. VAS5AL0TTIS? 1 RELATED TO YOUR WORK IN THE FIELD OF 2 TOXICOLOGY AND ENVIRONMENTAL AND OCCUPATIONAL 3 MEDICINE? 4 A. YES. I SERVE AS A CONSULTANT TO THE 5 UNITED STATES CONGRESS, THE SENATE COMMITTEE 6 OF PUBLIC WORKS FOR SEVERAL YEARS. 7 Q. WHEN WAS THAT? 8 A. A30UT 1959 TO ABOUT 1974, SOMETHING 9 LIKE THAT. 10 AND VARIOUS OTHER 11 CONGRESSIONAL COMMITTEES ON SUBSEQUENT 12 OCCASIONS SINCE THEN. I'VE CONSULTED 13 EXTENSIVELY AND ACTED AS AN EXPERT WITNESS 14 FOR THE ENVIROMENTAL PROTECTION AGENCY IN 15 PROCEEDINGS RELATING TO CANCER CAUSING 16 PESTICIDES AND ACTIONS TAKEN TO REMOVE THESE 17 FROM THE MARKET. I'VE ALSO CONSULTED AND 18 ACTED AS AM EXPERT WITNESS.FOR THE 19 OCCUPATIONAL SAFETY AND HEALTH COMMISSION 20 THAT GOES THE PART OF THE DEPARTMENT - OF 21 LABOR THAT HAS AUTHORITY AND JURISDICTION ON 22 PR03LEMS OF WORKERS HEALTH AND PUBLISHED 23 SAFETY AND HAVE INTERESTS IN THIS CONNECTION, 24 I WAS ON A COMMITTEE ESTA3LISHE0.IN 1973 BY 25 THE DEPARTMENT OF LABOR TO EXAMINE THE ASI-PR 0004311  r EXhM 1 NATIOM - SAMUEL EPSTEIN - MR. VA5SAL0TTlc* 1 QUESTION OF 5TANDARD SETTING CANCEL 2 CAUSING CrtE.-lICALS IN THE WORK PLACE. AND I'VE 3 ALSO 5ERVED AS CONSULTANT AND EXPERT IN OTHER 4 AGENCIES, INCLUDING THE NATIONAL INSTITUTE OF 5 HEALTH. OCCASIONS, I'VE SERVED.ON AN AOHOC 6 3ASIS AS CONSULTANT TO LA 3 OR, TO THE AFL-CIO, 7 I'VE ALSO SERVED AS CONSULTANT TO INDUSTRIES 8 THAT HAVE ASKED FOR MY SERVICES IN CONNECTION 9 WITH PROBLEMS IN THE WORK PLACE. 10 Q. DOCTOR, HAVE YOU WRITTEN ANY 11 ARTICLES THAT HAVE BEEN PUBLISHED IN ANY 12 SCIENTIFIC OR MEDICAL JOURNALS? 13 A. APPROXIMATELY 250 ARTICLES I'VE 14 WRITTEN IN -- WHICH HAVE APPEARED IN IS SCIENTIFIC JOURNALS. I'M AN AUTHOR OF 3^ OR 16 35 3GOK5. 17 Q. WELL, HAVE ANY OF THOSE ARTICLES 18 LET'S STICK WITH THOSE FOR AWHILE 19 OR THE BOOKS DEALT WITH ISSUES ARE CANCER OR 20 CANCER CAUSING CHEMICALS? 21 A. I WOULD SAY THE MAJORITY, THE GREAT 22 MAJORITY OF MY WRITINGS HAVE BEEN IN THE 23 AREAS OF CANCER, CANCER IN HUMANS, CANCER 24 CAUSATION, EXPERIMENTAL STUDIES IN ANIMALS 25 AND THE REGULATORY IMPLICATIONS OF THESE ASI-PR 0004312 cC' eXAMINAT ION - SAMUEL tP STEIN - MR. VASSALGTTI73 1 SC I ENT IF IC FINDINGS. 2 Q. HAVE YOU, IN PACT, ENGAGED IM 3 CLINICAL RESEARCH CANCER CAUSING CHEMICALS? 4 A. I'VE DONE VERY XTENSlVE. STUD IES IN 5 ANIMALS ON CERTAIN CARCI NOGEN ICS, EFFECTS OF 6 CHEMICAL, THAT IS THE ABILITY OF CHEMICALS TO 7 INDUCE IN ANIMALS AND ALSO SUSCEPTIBILITY* 8 Q. NOW, DOCTOR, YOU'VE MENTIONED YOU'VE 9 WRITTEN -- I THINK YOU SAID FOUR BOOKS THAT 10 DEALT WITH THE SUBJECT -- WELL, DO THEY DEAL n W1 TnE SUBJECT OF CANCER AND CANCER-CAUSING 12 CHEMICALS? 13 A. WELL, LET'S TRY TO REMEMBER. THE 14 FIRST BOOK WAS ON THE GENETIC HAZARD FROM 15 PESTICIDES, WHICH REALLY ISN'T DIRECTLY 16 RELATED TO CANCER, 3UT TIS IS ANOTHER SET OF 17 HAZARDS. THESE ARE HAZARDS FROM EXPOSURE TO '18 PESTICIDES. 19 ANOTHER 300K WAS ON THE NON 20 PSYCHIATRIC EFFECTS, HAZARDOUS EFFECTS OF 21 DRUGS OF ABUSE, THE ABILITY OF DRUG ABUSE TO 22 PRODUCE BIRTH DEFECTS, CANCER, GENETIC 23 A3MORMALITIE3. I'VE ALSO WRITTEN TWO VOLUMES 24 ON CONSUMER PRODUCT SAFETY, THE WHOLE 25 QUESTION OF HAZARD OF CONSUMER PRODUCTS, ASI-PR 0004313 EXAMINATION - SAMUEL EPSTEIN - MR. V A 5 S A L Q T TI 7 1 1 AMONG OTHERS, REFERENCE TO * THE *\* ABILITY OF 2 PRODUCTS TO PRODUCE CANCER. THE RECENT BOOK 3 OF ONE 15 ON THE -- IT WAS TITLED THE 4 POLITICS OF CANCER, WHICH DISCUSSES THE 5 SCIENCE OF CANCER. I HAD RANGE OF RELATED 6 PROBLEMS OF CANCER CAUSING CHEMICALS IN THE 7 ENVIRONMENT IN AIR, WATER FOOD AND THE WORK 8 PLACE AND DRUGS. I THINK THOSE ARE THE MAJOR 9 BOOKS WHICH I CAN RECALL. 10 Q. NOW, DOCTOR, IN YOUR WORK AS A 11 MEDICAL DOCTOR. -- PHYSICIAN, SPECIALIZING 12 IN THE TOXIC AND CANCER CAUSING EFFECTS OF 13 CHEMICALS, HAVE YOU BECOME FAMILIAR WITH A 14 DISEASE AS ANGIOSARCOMA OF THE LIVER? 15 A. YES. 16 Q. WHAT IS ANGIOSARCOMA OF THE LIVER? 17 A. IT IS A MALIGNANT OISEASE OR CANCER 18 IN A GENERAL SENSE. OF THE WORD. IT ISN'T A 19 TRUE CANCER, BECAUSE IT AFFECTS PARTICULAR 20 NON-EPITHELIAL CELLS IN THE BODY. IN THE 21 LAYMEN'S SENSE OF THE WORD, YOU CAN CALL IT A 22 CANCER OF BLOOD FORMING CELLS WHICH CAN OCCUR 23 IN DIFFERENT PARTS OF THE BODY, BUT IN 24 PARTICULAR IN THE LIVER, WHIC IS THE 25 PERHAPS THE COMMONEST SIGHT 0* WHICH IT HAS ASI-PR 0004314 J l .1 E C 'll cXA.1I NA T I ON SAMUEL EP3TEI-. MR. VASSALOTT l 72 1 BEEN NOTED. 2 Q. WELL, IS THAT A COMMON FORM OF 3 CANCER. I'M A LAYMAN. I'M GOING TO CALL IT 4 CANCER? 5 A. NO, IT'S A VERY RARE FORM OF CANCER. 6 0. " TO YOUR KNOWLEDGE, DOCTOR, ARE THERE 7 ANY KNOWN CAUSES OF ANGIOSARCOMA OF THE LIVER 8 THAT HAVE BEEN GENERALLY ACKNOWLEDGED OR* 9 ACCEPTED IN THE MEDICAL COMMUNITY? 10 A. YES, I THINK IT'S FAIR TO SAY THERE 11 ARE FOUR RECOGNIZED CAUSES. THE FIRST" IS 12 VINYL CHLORIDE, THE SECOND ARE ARSENIC 13 COMPOUNDS, THE THIRD IS THORIUM DIOXIDE OR 14 THORAS AND THE FOUR ARE ANTIBIOTIC STEROIDS. 15 Q. NOW, YOU MENTIONED, DOCTOR,THAT 16 VINYL CHLORIDE. IS ACCEPTED AS A PROBABLE 17 CAUSE OF ANGIOSARCOMA OF THE LIVER. IS THAT 18 THE GAS USED IN THE MANUFACTURER OF PVC? ARE 19 YOU FAMILIAR WITH THE dVC industry? 20 A. YES, YES. 21 Q. AN! VINYL CHLORIDE IS USED IN THE 22 MANUFACTURE OF PVC? 23 A. 24 Q . CORRECT. DOCTOR, ARE YOU FAMILIAR WITH THE 25 STRIKE THAT. ASI-PR 0004315 ! EC EXAMINATION SAMUEL EPSTEIN *3. VA5SalOTTl73 1 WHEN OIO IT BECAME 2 STRIKE THAT, A L 5 0. 3 IN THIS CASE, DOCTOR, 3.F. 4 GOODRICH COMPANY, I 3ELIEVE, IS TAKING THE 5 POSITION THAT IT WASN'T UNTIL THE VEP.Y END OF 6 1973 OR THE BEGINNING OF 1974 THAT THEY 7 REALIZED THAT THERE WAS ANY CONNECTION 8 BETWEEN VINYL CHLORIDE AND ANGIOSARCOMA OF 9 THE LIVER. ARE YOU FAMILIAR WITH THE 10 SCIENTIFIC AND. MEDICAL EVIDENCE IN RESEARCH 11 THAT LED TO THE CONCLUSION THAT VINYL 12 CHLORIDE WAS THE CAUSE OF CANCER AND 13 ANGIOSARCOMA OF THE LIVER BEFORE THAT TIME? 14 A. COULD I ASK YOU TO REPHRASE THAT, 15 3ECAUSE 16 MR. RENNEISEN: I'D LIKE TO 17 OBJECT TO THE QUESTION. 18 the court: I'm going to 19 SUSTAIN THE OBJECTION. LET'S ASK THE QUESTION. 20 LET'S NOT 21 22 YOUR HONOR. MR. VASSALOTTI: I'M SORRY, 23 THE COURT: GET TO THE 24 QUESTION AND LET'S NOT WAVE ANY STATEMENT. 25 BY MR. VASSALOTTI: ASI-PR 0004316 z C EXAMINATION - SAMUEL EPSTEIN - MR. V A 5 S A L 0 T T 1 7 '4 I Q. ARE YOU FAMILIAR WITH THE 2 DEVELOPMENT OF SCIENTIFIC AND MEDICAL 3 EVIDENCE IN RESEARCH THAT LED TO THE 4 CONCLUSION THAT VINYL CHLORIDE IS A CAUSE OF 5 ANGIOSARCOMA OF THE LIVER? 6 A. YES.. 7 Q.- ARE YOU A3 LE TO TRACE THE 8 DEVELOPMENT OF THAT LITERATURE FOR US HERE? 9 A. YES. I WOULD ALSO Lite TO INCLUDE IN 10 THIS TRACING A VERY BRIEF STATEMENT OF 11 EFFECTS OTHER THAN CANCER INDUCED 3Y VINYL 12 CHLORIDE, WHICH I THINK IT WOULD 3E HELPFUL 13 TO- THE COURT'S UNDERSTANDING OF THIS ISSUE, 14 IF I MAY. IS Q. OKAY. 16 A. I 'LL 17 MR.RENNEISEN: YOUR HONOR, I 18 WOULD OBJECT. I THINK COUNSEL SHOULD ASK 19 QUESTIONS AND THE WITNESS SHOULD ANSWER THE 20 QUESTIONS. THAT'S THE WAY 21 THE COURT: |*M GOING TO 22 ALLOW HIM TO INCLUDE THAT. OVERRULED. LET'S 23 PROCEED. 24 A. LET ME LIST BRIEFLYTHE CHRONOLOGY 25 OF INFORMATION THAT DEVELOPED 3EFORE 1374 ASI-PR 0004317  0 l R E C 1 EXAMINATION - SAMUEL EPSTEIN - Mil. VASSALOTTI75 \ < 2 3 4 5 6 7 .8 9 10 11 12 13 14 IS 16 17 18 19 20 21 22 23 24 25 WHEN IT F I 3 5 T PUBLISHED RECOGNITION OF THE cancer hazard OF VINYL chloride IN the WORK PLACE WERE KNOWN, AND I'LL DIVIDE NY ANSWER INTO TWO CLASSES. FIRST OF ALL, INFORMATION KNOWN WITH RESPECT TO ANIMAL STUDIES AND SECONDLY, INFORMATION KNOWN WITH RESPECT TO HUMAN DATA. THERE'S VERY EXTENSIVE LITERATURE GOING SACK TO 1930 ON THE EFFECTS OF VINYL CHLORIDE IN ANIMAL STUOIES AND AS EARLY AS 1930, THERE WERE REPORTS IN THE LITERATURE THAT VINYL CHLORIDE HAD VERT HIGH CONCENTRATIONS, FIVE PERCENT CONCENTRATIONS, COULD PRODUCE ACUTE TOXICITY IN ANIMALS. SUBSEQUENT TO THAT, FROM ABOUT 19X0 ON WARD, FROM 1930 TO 1950, THERE WERE SEVERAL PUBLICATIONS, AGAIN CONFIRMING THE ACUTE TOXICITY' -- THAT'S THE ABILITY GF HIGH CONCENTRATION OF VINYL CHLORIDE TO KILL AND IT WAS SHOWN THAT A CONCENTRATION OVER FIVE PERCENT, IT WOULD PRODUCE NARCOSIS, IT WOULD PRODUCE CARDIAC ARREST, AND PULQNARY EDEMA, THE LUNGS WOULD 3EC0ME FULL OF FLUID. FROM ABOUT 19 -- FROM ABOUT 19r+9 ONWARD, THERE WERE A SERIES OF PUBLICATIONS, ASI-PR 0004318 =b r mm EXAMINATION - SAMUEL EBSTEIN. - MS. VASSALOTT17' 1 PREDOMINANTLY IN THE EUROPEAN LITERATURE, AND 2 IT WAS KNOWN THAT VINYL CHLORIDE COULD 3 PRODUCE A WIDE RANGE OF EFFECTS IN ANIMALS, 4 DEGENERATIVE EFFECTS IN THE LIVER., 5 DEGENERATIVE KIDNEY CHANGES, TOO. AND BY THE 6 EARLY SIXTIES, IT WAS ALSO SHOWN THAT VINYL 7 CHLORIDE PRODUCED A TOXIC EFFECT ON BLOOD 8 VESSELS AND ALSO ON BONE, TOO. 9 Q. WHAT WAS THAT? 10 A. A TOXIC EFFECT ON BLOOD VESSELS, 11 CALLED ANGI OF I BROS IS AND ALSO AM EFFECT ON 12 BONE, THE LINING OF SONE, CALLED THE 13 PERIOSTEUM. 14 IN 1970, AN ITALIAN 15 PATHOLOGIST CAME OVER TO THIS COUNTRY AND 16 PRESENTED A PAPER AT THE INTERNATIONAL CANCER 17 CONGRESS IN HOUSTON, SHOWING THAT VINYL 18 CHLORIDE INDUCED CANCER IN RATS. THIS IN 1970 19 WAS THE FIRST PUBLISHED AND OPEN INFORMATION 20 ON THE CANCER CAUSING A3ILITY OF VINYL 21 CHLORIDE. 22 Q. WHO WAS IT, THE RESEARCHER WHO MADE 23 THOSE FINDINGS? 24 A. HIS NAME WAS VIOLA. H= W A 5 AM 25 EMPLOYEE OF ITALIAN INDUSTRY CALLED 5ULVATE ASI-PR 0004319  X AMI NAT I ON SAMUEL EPSTEIN MR. VASSALOTTI77 1 INDUSTRIES LIMITED IN ITALY. 2 5U3SEOUSNT TO VIOLA'S 3 FINDINGS, THESE -- THIS INFORMATION WAS 4 CONFIRMED AND EXTENDED 3Y ANOTHER ITALIAN 5 PATHOLOGIST CALLED MATALONI, WHO BY 1972, 3Y 6 AUGUST -- OR 3 Y THE FALL OF 1972, HAD 7 CONFIRMED AND EXTENDED THESE FINDINGS, 8 ALTHOUGH INFORMATION ON THIS WAS NOT MADE 9 AVAILABLE UNTIL 1974, THE SAME DAY THAT THERE 10 WAS THE PU3LISHED ANNOUNCEMENT OF THE 11 OCCURRENCE OF THE CANCER IN THE 8.F. GOODRICH 12 WORKERS . THAT VERY BRIEFLY IS THE STATEMENT 13 OF IT IN ALL LITERATURE. 14 AS FAR AS THE HUMAN STUDIES 15 ARE CONCERNED, THE EARLY LITERATURE ON THIS, 16 VERY INTERESTINGLY, IS EUROPEAN. THERE WERE 17 VERY LITTLE IN THEWAY OF AMERICAN STUDIES 18 PU3LISHEO on THE HUMAN EFFECTS OF VINYL 19 CHLORIDE. 20 ONE OF THE VERY EARLY 21 IMPORTANT PAPERS WAS A RUSSIAN PAPER IN 1949, 22 WHICH SHOWED THAT EXPOSURE TO VINYL CHLORIDE 23 COULD PRODUCE CHROMIC HEPATITIS -- THAT'S 24 TOXIC EFFECT IN THE LIVER, GASTRITIS, S<IN 25 IRRITATION, AND THIS WAS SHOWN IN A GROUP OF ASI-PR 0004320 SC X*MINAT!OM " SAMUEL EPSTEIN - VA S 5 AL0T T I 7 1 73 RUSSIA* WORKERS. AND THIS WAS SUBSEQUENT 2 TO THAT. 3 IN 1957, IT WAS SHOWN THAT AT 4 LEVELS LOWER THAN RUSSIAN STANDARDS -- THE 5 RUSSIAN STANDARD THEN WAS ABOUT 390 PARTS PER 6 MILLION -- THAT IT WAS SHOWN AT LEVELS 7 BELOW THAT THAT VINYL CHLORIDE WOULD PRODUCE 8 TOXIC EFFECTS KNOWN AS TOX IC ANGI ONEUROPATHY. 9 Q. WHAT IS THAT? 10 A. IT MEANS AN IRRITANT E F P E C T OF BLOOD 11 VESSELS AND NERVES TO THE BLOOD VESSELS. 12 IN THE SAME TEAR, IT WAS 13 SHOWN THAT VINYL CHLORIDE WOULD PRODUCE 14 RAYNAUD'S DISEASE. RAYN'AUD'S DISEASE IS A 15 DISEASE WHICH IS RECOGNIZED IN LAY TERMS 3T 16 HANDS GOING VERY COLD AND BECOMING NUrtB AND 17 GOING VERY COLD AND THE SKIN BECOMING WHITE. 18 AND this WAS ASSOCIATED WITH SOME BQNEY 19 CHANGES KNOWN AS ACR00STE0LYS I S. BY 195 3, A 20 CHARACTERISTIC PICTURE HAD EMERGED OP THE 21 TOXIC EFFECT5 OF -- OF VINYL CHLORIDE AND 22 THIS WAS WELL SUMMARIZED, AGAIN, IN A FOREIGN 23 PUBLICATION BY SUCIO, S-U-C-I-O, IN 1953, 24 WHERE IT WAS SHOWN THAT VINYL CHLORIDE 25 PRODUCED HEPATITIS, SPLENOMEGALY, A BIG ASI-PR 0004321 XAM I NAT I ON SAMUEL EPSTEIN MR. VASSALOTT{79 1 SPLEEN, DERMATITIS, IRRITATION OF THE SKIN, 2 RAYNAUD'S DISEASE, WHICH WE'VE TALKED ABOUT 3 ALREADY, GUT UP DISTURBANCE, CENTRAL NERVOUS 4 SYSTEM DISTURBANCES AND THIS WAS VERY WELL 5 DESCRIBED, AS I SAY, IN 1955. THREE YEARS 6 LATER IN A BELGUIM PUBLICATION, THERE WAS A 7 FURTHER CONFIRMATION OF VINYL CHLORIDE 8 PRODUCED ACROOSTEOLYS I S THAN RAYNAUD'S 9 DISEASE, AND BY 1970, 1972, IT WAS SHOWN THAT 10 A DOSE RESPONSE EFFECT COULD 3E PRODUCED; IN 11 OTHER WORDS, OVER THE HIGH CONCENTRATIONS OF 12 VINYL CHLORIDE, THE WORST THESE DISEASES -- 13 THE WORST THE DISEASE, THE WORST WERE THE 14 INCIDENCES OF THE DISEASE AND THE WORST WERE 15 THE SYMPTOMS. AND IT WAS SHOWN THEY WERE 16 PRODUCED OVER A RANGE OF 35 TO ?0Q PARTS PER 17 MILLION AND THE DIFFICULTY WAS EVEN NOTED AT 18 LEVELS OF 40 ARTS PER MILLION. 19 20 Q. NOW, COMING CLOSER TO DOCTOR, LET ME INTERRUPT YOU FOR A 21 SECOND. 22 ALL THESE PUBLICATIONS AND 23 ARTICLES THAT YOU REFER TO, WERE THESE 24 ARTICLES GENERALLY AVAILA3LE IN MEDICAL 25 LITERATURE TO PERSONS WHO MAY HAVE SEEN ASI-PR 0004322 EC EXAMINATION - SAMUEL S 3 S T E IN - Ml. `/A S 3 A LO^T I 1 INTERESTED IN FINDING OUT ASOUT THE TDXICITY 2 OR EFFECTS OF VINYL CHLORIDE? 3A certainly, these articles were 4 PUBLISHED IN THE OPEN SCIENTIFIC LITERATURE 5 AND ANYBODY WHO HAD ANY INTEREST AT ALL IN 6 THIS ISSUE COULD HAVE HAD ACCESS TO THIS 7 MATERIAL 8 now, there are some other 9 INTERESTING POINTS. PRIOR TO -- WELL, LET 10 ME J'JST GO 3 AC < ON THAT FOR ONE MOMENT. 11 PRIOR TO 1 71, EIGHT CASES CP 12 CANCER OF THE LIVER HAD BEEN NOTED IN VINYL 13 CHLORIDE WORKERS. EIGHT CASES OF CANCER OF 14 THE LIVER HAD BEEN NOTED IN VINYL CHLORIDE*, 15 POLYVINYLCHLORIDE WORKERS PRIOR TO 1971. ONE 16 OF THESE HAD OCCURRED IN SWEDEN, SEVEN 17 OCCURRED IN THE UNITED STATE.-S, THREE CF WHICH 18 WERE IN 3.F. GOODRICH. ALL THESE EIGHT CASES 19 WERE SUBSEQUENTLY REDIAGNOSED AS ANGIOSARCOMA. 20 IT IS OF INTEREST THAT ONE OF THESE THREE * 21 CASES OCCURRED IN A B.F. GOODRICH WORKER WHO 22 IN 19*5 HAD RECEIVED WORKMEN'S COMPENSATION 23 FOR TOXIC HEPATITIS BUT HAD BEEN RETURNED TO 24 WORK SUBSEQUENTLY. 25 NOW, OVER AND A 3 0 VE THESE ASI-PR 0004323 c C eXhHI.SAT I ON - 5 AM-J EL EPSTEIN - MR. VASSAL OTTI * x 1 cIGrtT CAUSES CF LIVER CANCER IM VINYL 2 CHLORIDE WORKERS WHICH HAD OCCURRED PRIOR TO 3 1975, THERE'S SOME OTHER INTERESTING 4 INFORMATION ON THE CANCER-CAUSING EFFECTS OF 5 VINYL CHLORIDE IN HUMANS. DOCTOR MATALONI IN 6 1959 HAD DEMONSTRATED MALIGNANT TYPE CELLS IN 7 THE SPUTUM OF VINYL CHLORIDE WORKERS. IN 8 OTHER WORDS, ONE WAY OF DIAGNOSING LUNG 9 CANCER, EFFECTIVELY IF YOU'RE TRYING TOO PICK 10 IT UP AT AN EARLY STAGE, TO GET SOMEBODY TO 11 SPIT INTO A LITTLE POT. YOU GET THE SPUTUM, . 12 YOU LOOK IN THE CELLS AND 3Y LOOKING AT THE 13 CELLS YOU CAN TELL WHETHER THEY'RE CANCER 14 TYPE CELLS OR NOT. ANIMALS IN 19S9, HAD 15 ALREADY SHOWN THAT THERE WAS A HIGH INCIDENCE 16 OF CANCER LIKE CELLS IN THE SPUTUM OF VINYL 17 CHLORIDE WORKERS. INTERESTINGLY ENOUGH, THIS 18 INFORMATION WAS NOT MADE AVAILABLE IN THE 19 OPEN SCIENTIFIC LITERATURE UNTIL 1975. SO, IT 20 IS -- TO SUMMARIZE, I WOULD SAY THAT THERE 21 WAS EXTENSIVE EVIDENCE OF TOXIC EFFECTS OF 22 VINYL CHLORIDE, 30TH IN ANIMALS AND IN HUMANS, 23 PRIOR TO 19 7 A, THE 3UL< OF THIS LITERATURE ON 24 THE CHRONIC TOXIC EFFECTS COMING FROM THE 25 European literature. auT there were also very ASI-PR 0004324 EXAMINATION! SAMUEL EPSTEIN MR. VASSALOTTI*2 1 CLEAR INDICATIONS OF IT5 CARCINOGENICITY AS 2 EVIDENCED BY THE VIOLA APER IN 197!}, THE 3 EIGHT CASES OF LIVER CANCER WHICH HAD 4 OCCURRED IN THIS COUNTRY AND IN SWEDEN, WHICH 5 WERE SUBSEQUENTLY DIAGNOSIED AS ANGIOSARCOMA, 6 AND PERHAPS LESS ACCESSIBLE WERE THE FINDINGS 7 OP MATALONI, THE TWO KINDS OF FINDINGS OF 8 MATALONI, ONE, THE EXPERIMENTAL CONFIRMATION 9 OF THE CANCER-CAUSING EFFECTS IN ANIMALS AND 10 THE MALIGNANT CELLS IN SPUTUM. 11 HOWEVER, I SHOULD MENTION 12 THAT MATALONI 'S INFORMATION ON THE CANCER13 CAUSING EFFECT OF VINYL CHLORIDE IN ANIMALS, U WHICH AS I INDICATED BEFORE, HAD BEEN 15 OBTAINED BY THE FALL OF 1972, WAS 16 COMMUNICATED TO THE AMERICAN INDUSTRY, TO Th 17 MANUFACTURING CHEMISTS* ASSOCIATION. 18 MR. RENNEISSN: OBJECTION, 19 YOUR HONOR, UNLESS THERE'S EVIDENCE IT WAS 20 COMMUNICATED TO 3.F. GOODRICH COMPANY. HE 21 SAID IT WASN.'T MADE AVAILABLE TO THE PUBLIC. 22 AND IT'S GROSS HEARSAY AS TO 23 THE COURT: WELL, THIS HAS 24 BEEN AN EXPERT IN THE cIE LO . I'M GOING TO 25 ALLOW IT. I * M GOING TO ALLOW IT. ASI-PR 0004325 c C EXA.-lK^TIC'S - SAMUEL EPSTEIN - MR. VASSALOTTI ; 3 1 HR. VASSALOTTI: YOUR HONOR, 2 I MIGHT FURTHER ADD 3 MR. RENNEI5EN: THE JUDGE HA 5 4 RULED. I DON'T THINK IT'S TIME FOR COUNSEL 5 TO MAKE A SPEECH. I OBJECT. 6 BY MR. VASSALOTTI: 7 q. DOCTOR, YOU MENTIONED THAT PROFESSOR 8 MATALONI'S FINDINGS WERE COMMUNICATED TO AN 9 ORGANIZATION CALLED THE MANUFACTURING 10 CHEMISTS ASSOCIATION? IT A. THAT IS CORRECT. 12 Q. AND WHEN WHAT WAS.THAT? 13 A. 14 LET Me GIVE YOU THE DETAILS OF THIS. IN AUGUST, 1972, THE 15 MANUFACTURING CHEMISTS' ASSOCIATION -- THAT 16 IS, THE TRADE LOBBY, THE ASSOCIATION IN THIS 17 COUNTRY THAT REPRESENTS THE CHEMICAL INDUSTRY 18 ENTERED INTO AN UNDERSTANDING WITH A 19 CONSORTIUM OF AMERI CAN-EUR OPEAM INDUSTRIES. 20 MR. RENNEISEN: YOUR HONOR, I 21 OBJECT. THIS, IS SIMPLY NOT MEDICAL EXPERT 22 TESTIMONY. 23 THE COURT: I'M GOING TO 24 SUSTAIN THE G3JECTION. IT'S GOME A LITTLE BIT 25 TOO FAR ASI-PR 0004326 EXAMINATION - SAMUEL EPSTEIN - MR. VASSALOTT I ** 4 1 3Y MR. VASSALOTTI: 2 O. IF YOU COULD, DOCTOR EPSTEIN, JUST 3 LIMIT YOURSELF TO THE DEVELOPMENT OF 4 KNOWLEDGE REGARDING 5 A. FINE. SY OC TOBER, *7 2, MAT ALONI HAD 6 CONFIRMED -- HAD REPEATED THE KIND OF 7 STUDIES THAT VIOLA HAD DONE AND HAD SHOWN 8 EFFECTS AT LOWER CONCENTRATIONS AND ON A 9 WIDER RANGE OF ORGANS. 10 Q. WHAT CONCENTRATIONS, WHAT LEVELS OF 11 . EXPOSURES DID HE TEST? 12 A. MATALONI WENT DOWN TO THE HUNDRED 13 P.P.M. KIND OF 3ALLPARK LEVEL AND HAD, IN 14 FACT, LEVELS WERE FOUND, CONCENTRATIONS 13 MATALONI'S SUBSEQUENT STUDIES HAD, IN FACT, 16 DEMONSTRATED CARCINOGENIC EFFECTS DOWN TO ONE 17 PART PER MILLION IN SUBSEQUENT STUDIES OF 18 MATALONI. 3UT BY72, EFFECTS IN THE HUNDRED 19 PARTS PER MILLION HAD SEEN DEMONSTRATED. AND 20 THIS INFORMATION FIRST 3ECAME AVAILABLE IN 21 JANUARY, 197>, THE SAME DAY AS THERE WAS A 22 THE PU3LIC ANNOUNCEMENT SY S.F. GOODRICH ON 23 THE OCCURRENCE OF FOUR CANCERS IN ITS WORKERS 24 IN THE LOUISVILLE -- FOR ANGIOSARCOMAS IN 25 THE LIVER IN WORKERS IN ITS B. F. GOODRICH ASI-PR 0004327 DIRECT ~ A - A I NAT I O N SAMUEL EPSTEIN -I3,. VAS5ALOTT I 1 PLANT, IN ITS PLANT IN LOUISVILLLE, KENTUCKY. 2 U. DOCTOR, YOU'VE MENTIONED AnIMAL 3 TESTS WERE DONE. DID THAT INCLUDE TESTS ON 4 RATS? IS THAT WHAT MATALONI AND VIOLA DIO? 5 A. VIOLA'S STUDIES WERE ON RATS. 6 MATALONI STUDIES WERE MORE EXTENSIVE. THEY 7 INCLUDED MICE, RATS, HAMSTERS AND THEY WERE A 8 VERY, VERY EXTENSIVE SET -OF STUDIES. 9 0. WHAT'S THE SIGNIFICANCE OF THE 10 MEDICAL FIELD AND PARTICULARLY IN THE FIELDS 11 OF CANCER-CAUSING CHEMICALS OF ANIMAL TESTS 12 IN THE STUDIES? 13 A. IT'S GENERALLY ACCEPTED 3Y ALL 14 AUTHORITIES IN THE FIELD THAT TESTS IN 15 ANIMALS AFFORD A PROPER METHOD OP PREDICTING 16 WHETHER A CHEMICAL IS LIKELY TO INDUCE CANCER IN HUMANS. AND TEST5 IN ANIMALS FOR THIS 18 REASON ARE STANDARD METHODS OF FINDING 19 WHETHER A CHEMICAL IS LIKE TO RE CARCINOGENIC 20 CR OTHERWISE AND TH METHODOLOGY FOR CANCER 21 TESTING IN .ANIMALS ARE FAIRLY WELL DEVELOPED 22 AND HAVE BEEN SO WELL DEVELOPED FOR DECADES. 23 THERE'S A WIDE RANGE OF EXPERT, BODIES 24 NATIONALLY AND INTERNATIONALLY THAT HAVE 25 UNEQUIVOCALLY CONCLUDED THAT INFORMATION ASI-PR 0004328 EC EXAMINATION - SAMUEL EPSTEIN - MR. VAS5AL0TTI?$ 1 DERIVED FROM WELL DEVELOPED ANIMAL TESTS GIVE 2 YOU A REAL PREDICTION AS TO THE LKLIHOOD Op 3 WHETHER A CHEMICAL WOULD INDUCE CANCER IN 4 HUMANS OR NOT. 5 Q. DOCTOR, DOES THE MEDICAL LITERATURE 6 OR STATE OF THE MEDICAL ART AT THE PRESENT 7 TIME ESTABLISH HOW VINYL CHLORIDE CAUSES 8 CANCER? 9 A. THE ANSWER IS NO, AND IT'S ALSO 10 CLEAR TO SAY THAT WE DON'T KNOW THE MECHANISM 11 OF ACTION OF ANY CHEMICAL CARCINOGEN. YOU CAN 12 DESCRIBE SOME OF THE EFFECTS OF A CHEMICAL 13 CARCINOGEN', THAT IT PRODUCES A DISTURBANCE OF 14 THIS METABOLIC SYSTEM, THIS BIOCHEMICAL 15 SYSTEM, THIS IMMUNOLOGICAL SYSTE*,.!UT WE 16 DON'T KNOW THE MECHANISM OF ACTION OF 17 CARCINOGENS, INCLUDING VINYL CHLORIDE. 18 WE KNOW MANY THINGS ABOUT THE 19 OCCURRENCE OF THE -- HOW THE CARCINOGENIC 20 PROCESS DEVELOPS, BUT WE DON'T KNOW THE 21 MECHANISM. 22 Q. DOCTOR, HAVE ANY OF THE MEDICAL OR 23 SCIENTIFIC STUDIES DONE TO DATE SHOWN THAT 24 THERE IS ANY SAVE LEVEL OF VINYL CHLORIDE 25 EXPOSURE TO WHICH A HUMAN COULD 3E EXPOSED? ASI-PR 0004329 EC EXAMINATION - SAMUEL EPSTEIN - M5 . VASS^LOTTj *7 1 A. LET ME ANSWER THAT IN TWO PARTS: 2 FIRSTLY, 8 Y SAYING THAT IT IS THE CONSENSUS 3 OF THE INFORMED SCIENTIFIC COMMUNITIES THAT 4 E DON'T KNOW OF ANY WAY OF SETTING SAFE 5 LEVELS FOR CHEMICAL CARCINOGENS AND THERE'S 6 OVERWHELMING EVIDENCE IN LITERATURE TO 7 SUPPORT THIS. WE JUST DON'T KNOW OF ANY SAFE 8 WAY. AND THE SAME OBTAINS AS FAR AS VINYL 9 CHLORIDE IS CONCERNED 10 WITH VINYL CHLORIDE, HOWEVER, 11 OVER AND ABOVE THE VERY GENERAL STATEMENT 12 THAT WE DON'T KNOW OF ANY WAY 0* SETTING SAFE 13 LEVELS FOP. SAFE LEVELS FOR CHEMICAL 14 CARCINOGENS, I SHOULD POINT OUT THAT WE HAVE 15 EXTENSIVE INFORMATION ON THE FACT THAT VINYL 16 CHLORIDE CAN PRODUCE CARCINOGENIC EFFECTS AT 17 LOW CONCENTRATIONS. NOW, WHEN I SAY LOW 18 CONCENTRATIONS, I HAVE TO EXPLAIN WHAT I M'S AN 19 8 Y LOW CONCENTRATIONS. ONE PART PER MILLION 20 MAY SOUND VERY LITTLE INDEED. ONE PART PER 21 MILLION IS ABOUT 2,SQ0 MICROGRAMS PER CUBIC 22 METERS, WHICH MEANS IF YOU WANT TO TRANSLATE 23 ONE PART PER MILLION IN TERMS Oc NUMBER OF 24 MOLECULES YOU BREATHE IN EVERY BREATH Or AIR, 25 WE'RE TALKING ABOUT -- NOT MILLIONS OF ASI-PR 0004330 c. X A A 1 N A T 1 01'\ SAMUEL EPSTEIN r.R. VASSALOTTI33 1 MOLECULES, NOT BILLIONS, WE * 9 E TALKING ABOUT 2 MORE THAN QUADRILLIONS OF MOLECULES. 3 NOW, AS I SAID BEFORE, WE 4 HAVE EXTENSIVE EVIDENCE ON THE 5 CARCINOGENICITY OF VINYL CHLORIDE AT LOW 6 * CONCENTRATIONS AND LET ME, IF I MAY, BRIEFLY 7 SUMMARIZE THIS FOR YOU. 8 0. COULD YOU, DOCTOR? 9 A. FIRST OF ALL, IN THE OVERWHELMING 10 MAJORITY OF CARCINOGENS OF THE TESTS THAT 11 HAVE 3 EEN SHOWN ON VINYL CHLORIDE IN ANIMALS, 12 CANCER-CAUSING EFFECTS HAVE BEEN DEMONSTRATED 13 AT THE LOWEST LEVEL TESTEO. LET'S SAY 50 14 PARTS PER MILLION WAS THE LOWEST LEVEL TESTED. 15 CANCER CAUSING EFFECTS WERE DEMONSTRATED AT 16 THAT. THAT DOESN'T MEAN TO SAY THAT 50 PARTS 17 PER MILLION IS A SAFE LEVEL -- THERE'S NO 18 SUCH THING AS A SAFE LEVEL. THAT SIMPLY MEANS 19 THAT 53 PARTS WAS THE LOW TEST OOSE TESTED. 20 HOWEVER, MATALON I HAS DONE 21 EXPERIMENTS JN WHICH HE HAS FOUND THE 22 INDICATION OF CANCER OF THE BREAST IN RATS AT 23 ONE POINTS PER MILLION. WITH INTERMITTENT 24 EXPOSURE OVER A YEAR. WITH INTERMITTENT EXPOSURE OF RATS TO LEVELS OF VINYL CHLORIDE ASI-PR 0004331 EXAM I NA 7 I ON SAMUEL E S TE IN v*9. va?SALOtTIo 1 AT ONE PART PER MILLION, HE HAS DEMONSTRATES 2 CANCER INDUCED 3Y VINYL CHLORIDE. OVER AN AND 3 A 3 0 V E THIS, WE ALSO <NOW THAT YOU DON'T NEED 4 VERY LONG AND SUSTAINED EXPOSURES TO VINYL 5 CHLORIDE TO GET CANCER. AS LITTLE AS ONE 6 HOUR IS ENOUGH TO GIVE YOU CANCER. 7 Q. HAS THERE BE ANY RESEARCH IN THAT 8 REGARD, DOCTOR? 9 A. YES. THERE IS A VERY EXTENSIVE STUDY 10 BY THE CONSUMER PRODUCTS SAFETY COMMISSION 11 THAT SHOWS THAT ONE HOUR EXPOSURE OF ANIMALS 12 TO VINYL CHLORIDE -WILL PRODUCE CANCER-CAUS I NS 13 EFFECTS. AND THE SAME DOCUMENT FROM THAT 14 CONSUMER PRODUCTS SAFETY COMMISSION WARNS 15 EXPLICITLY OF THE DANGERS OF SPILLS OF VINYL 16 CHLORIDE BECAUSE ONE EXPOSURE AS SHORT AS AN 17 HOUR CAN PRODUCE THESE EFFECTS. SO, ALREADY 18 .WE HAVE SEEN WITHOUT REVIEWING THE WIDE RANGE 19 OF ANIMAL TEST ON -- ON THE CARCINOGENIC 20 EFFECTS OF VINYL CHLORIOE, WE'VE SEEN ONE 21 POINT ONE, THE LOWEST LEVEL TESTED SO FAR. 22 ONE PART PER MILLION, CANCER CAUSING EFFECTS 23 WERE INDUCED BY VINYL CHLORIDE. TRUE, CANCER 24 CAUSING EFFECTS WERE CAUSED BY AS SHORT A 25 PERIOD OF AN HOUR. ASI~pr 0004332 It EXAMl WAT IGN - SA.'UEL EPSTEIN - MR. VASSAL OTTI 90 1 2 Q. LET'S EXAMINE THAT. DOCTOR, IS THERE ANY INDICATION 3 WE'VE SEEN TALKING ABOUT ANIMALS OF THESE 4 LOWER LEVELS. IS THERE ANY MEDICAL LITERATURE 5 WHICH INDICATES THAT HUMANS ARE AT RISK OF 6 DEVELOPING CANCER, AND ANGIOSARCOMA OF THE 7 LIVER IN PARTICULAR, FROM THESE LOW LEVELS OF 8 VINYL CHLORIDE EXPOSURE? 9 A. ' YES, 10 MS. RENNEI.SEN: YOUR HONOR, I 11 OBJECT TO THE QUESTION. I DON'T THINK AT RISK 12 IS WHAT WE'RE TALKING ABOUT HERE. 13 THE COURT: WHY DON'T YOU 14 REPHRASE YOUR QUESTION. 15 BY MR. VASSALOTTI: 16 Q. DOCTOR, IS THERE ANY MEDICAL 17 EVIDENCE TO INDICATE THAT HUMANS EXPOSED TO 18 LOW LEVEL CONCENTRATIONS OF VINYL CHLORIDE 19 CAN: DEVELOP AND DO DEVELOP CANCER AND 20 PARTICULARLY ANGIOSARCOMA OF THE LIVER? 21 A. YES, THERE IS SUCH EVIDENCE. 22 Q. CAN YOU DESCRIBE 23 A. AND THE EVIDENCE RELATES TO TWO 24 TYPES OF -- TO TWO LINES OF STUDY. THE 25 FIRST ARE THE OCCUPATIONAL STUD I5 IN THE ASI-PR 0004333 EC EXAMINATION! - SAMUEL EPSTEIN - MR. VA S S ALO T T I ^ 1 I WCRK PLACE. THE SECOND ARE STUDIES IN -THE 2 COMMUNITY, PEOPLE VJHQ LIVE CLOSE TO LANTS. 3 AND LET ME FIRST OF ALL DISCUSS THE EVIDENCE 4 FOR THE CARCINOGENICITY OP VINYL CHLORIDE IN 5 THE WORKPLACE AT LOW LEVELS OF EXPOSURE. 6 NOW, I SHOULD EXPLAIN THAT 7 THERE'S THREE KINDS OF PROCESSES IN WHICH A 8 WORKER IN THE -- IN THE VINYL CHLORIDE, 9 POLYVINYLCHLORIDE PLASTIC INDUSTRY IS 10 ASSOCIATED, THE FIRST IN THE MANUFACTURE OF 11 VINYL CHLORIDE. VINYL CHLORIDE IS A SMALL 12 BUILDING BLOCK WHICH WHEN STRUNG TOGETHER 13 FORMS LONG CHAINS CALLED POLYYINYLCHLORIDE. 14 SO, IN The PROCESS, THE worker can be exposed 15 TO VINYL CHLORIDE WHEN HE MAKES THE VINYL 16 CHLORIDE, THAT'S ONE; TWO, WHEN THE VINYL 17 CHLORIDE IS COOKED IN A PRESSURE POT, WHEN 18 THE SMALL MOLECULES ARE STRUNG TOGETHER TO 19 FORM POLYVINYL CHLORIDE, AND WHEN YOU MAKE 20 THE VINYL CHLORIDE AND WHEN YOU MAKE THE 21 POLYVINYLCHLORIDE, LEVELS OF EXPOSURE CAN BE 22 VERY HIGH, CAN BE PARTICULARLY IF WORK 23 PR ACT ICES' ARE BAD . 24 THERE'S A THIRD KIND OF 25 EXPOSURE ASI-PR 0004334 EC tAAM I NAT ION 54MUEL EPSTEIN MR. /AS5ALOTTI 92 1 mr. renneisen: YOU* HONOR, I 2 DON'T LIKE TO KEEP OBJECTING. BUT I WAS UNDER 3 THE IMPRESSION THAT HE WAS TELLING US ABOUT 4 HOw PEOPLE CAN GET CANCER FROM LOW LEVELS AND 5 HE'S JUST TOLD US ABOUT HIGH LEVELS. 6 MR. VASSALOTTI: YOUR HONOR, 7 I THINK HE'S DESCRIBING -- AND I DON'T WANT 8 TO PUT WORDS IN YOUR MOUTH, DOCTOR -- THE 9 DIFFERENCE IN EXPOSURE LEVELS. 10 MR. RENNEISEN: THAT WASN'T 11 THE QUESTION THEN. I ASK THAT THE ANSWER BE 12 STRICKEN AND THAT QUESTION 3E ASKED. 13 THE COURT: I '.M GOING- TO * 14 ALLOW IT. I THINK THE JURY SHOULD HEAR THIS 15 BACKGROUND. WE HAVE AN EXPERT. YOU HAVE NOT 16 OBJECTED TO HIS QUALIFI CAT IONS. THE COURT 17 FINDS HIM WELL QUALIFIED. THE COURT WILL 18 ALLOW THIS. IT BEARS EXACTLY ON THE ISSUES IN 19 THIS CASE. 20 THE WITNESS: THE THIRD KIND 21 OF EXPOSURE -IS THE EXPOSURE WHERE LEVELS ARE 22 LOW. AND WHEN YOU TAKE THE POLYVINYL RESIN 23 AND YOU WORK ON IT, YOU MAKE PHONOGRAPHS, YOU 24 MAKE PLASTIC. THAT IS WHAT WE CALL 25 FABRICATION. SO, I'M MAKING DISTINCTIONS ASI-PR 0004335 EXAMINATION - SAMUEL EPSTEIN - MR. VASS4LOTTI?5 1 BETWEEN TWO KINDS OF EXPOSURES TO VINYL 2 CHLORIDE . 3 THE VERY LOW LEVELS, WHEN YOU 4 TAKE THE VINYL -- THE PRODUCT, THE 5 POLYVINYLCHLORIDE PRODUCT AND MAKE THINGS 6 LIKE RECORDS OR WHAT HAVE YOU OR GARDEN HOSE, 7 AND WHEN YOU FA3RICATE -- WHEN YOU 8 FABRICATE THE POLYVINYLCHLORIDE, THE LEVELS 9 OF VINYL CHLORIDE ARE VERY LOW, COMPARED TO 10 WHAT THEY ARE WHEN YOU EITHER MANUFACTURE THE 11 VINYL CHLORIDE OR WHEN YOU HANDLE THE 12 POLYVINYLCHLORIDE. OKAY. 13' SO, THE RELEVANCE OF ALL THIS 14 IS AS FOLLOWS: IN THE POLYVINYLCHLORIDE . 15 FABRICATION, LEVELS OF VINYL CHLORIDE 16 EXPOSURE ARE LOW AND THERE WAS 4 STUDY ST THE 17 NATIONAL INSTITUTE OF OCCUPATIONAL SAFETY AND 18 HEALTH IN 1973 WHICH DID A SURVEY OF 19 FA3RICATING PLANTS, EVERY VINYL CHLORIOE 20 FABRICATING PLANT, IN WHICH THET SHOWED THE * 21 LEVEL OF VINYL CHLORIDE IN THE FA3RICATING 22 PLANT, RANGED FROM THE NONDETECTABLE 23 THEY WERE SO LOW YOU COULDN'T PICK THEM UP TO 24 A MAXIMUM OF ABOUT TWO PARTS PER MILLION. 25 OKAY. SO, WE'RE DEALING NOW WITH AN INDUSTRY, ASI-PR 0004336  C EXAM I NAT I ON SAMUEL EPSTEIN MR. VASSALOTT !*'+ 1 TrtE POlYVINYLCHLORIDE FABRICATION INDUSTRY IN 2 WHICH THE LEVELS OF VINYL CHLORIDE EXPOSURE 3 IS DEMONSTRABLY LOW. LET US NOW EXPERIENCE 4 THE EXPERIENCE IN THIS INDUSTRY TO SEE WHAT 5 IS THE EFFECT AND YOU'LL GET SOME INDICATION 6 THERE. 7 WE FIND, FIRST OF ALL, IN A 8 PLANT IN CONNECTICUT IN PUBLICATION CHRISTINE, 9 19 7 4, TWO ANGIOSARCOMAS OF THE LIVER WERE 10 DESCRIBED IN 1974. ONE OF THESE CASES WASN'T 11 EVEN A WORKER, HE WAS AN ACCOUNTANT, NOT 12 LIKELY TO BE TOOLING AND FABRICATING THE 13 STUFF ALL DAY LONG. SO, IN THESE PLANTS WHERE 14 LEVELS OF EXPOSURE ARE LOW,. TWO ANGIOSARCOMAS 15 ARE DESCRIBED, INCLUDING ONE ACCOUNTANT. 16 WHAT ELSE DO WE FIND? IN A 17 PU3LISHED TEXT 3Y BAXTER IN 1947, AN 18 ANGIOSARCOMA OF THE WORKER IN A 19 POLYVINYLCHLORIDE FABRICATOR. WHAT ELSE DO WE 20 FIND? 21 COULD I TROUBLE YOU cOR A 22 DROP OF WATER, PLEASE? 23 WHAT ELSE DO WE FIND? IN 24 ANOTHER STUDY, IN A BRITISH PLANT, BY BAXTER, 25 .* FIND -- WE FIND AN EXAMPLE OF CANCER OF ASI-PR 0004337 X Art I N A T l ON - SAMUEL EPSTEIN - MR. VASSALOTTl^S THE STOMACH IX A GROUP OF A 30 UT 700 fabricators, cancer of another site, and FINALLY, WE find IN A SERIES OF 17 POLYVINYLCHLORIDE PLANTS LOOKED AT IN THIS COUNTRY, AN EXCESSIVE CANCERS OF VARIOUS SITES, GUTS, LUNG, LYMPHATIC SYSTEM AND 3 REAS T. SO, MY SECOND LINE OF EVIDENCE I * VE ALREADY TOLD YOU ABOUT THE HUMAN DATA, the animal data, the second line of evidence RELATES TO THE OCCUPATIONAL DATA IN WHICH ANGIOSARCOMAS and other malignancies are DESCRIBED IN WORKERS EXPOSED TO WHAT COULD IN THIS CONTEXT BE CALLED RELATIVELY LOW LEVELS. LET US NOW LOOK AT A THIRD TYPE OF PIECE OF INFORMATION IN EVIDENCE; THAT IS, COMMUNITY CANCER. COMMUNITY CANCER Q. WHAT Dp YOU MEAN BY COMMUNITY CANCER, DOCTOR? A. FINE. Wr.AT I MEAN 3Y COMMUNITY CANCERS ARE CANCERS OCCURRING- IN RESIDENTS WHO LIVE IN- -- PEOPLE LIVING IN CLOSE PROXIMITY TO VARIOUS INDUSTRIES. AND THERE'S A GROWING 30DY OF INFORMATION SUGGESTING -- SUGGESTING IS PERHAPS NOT A SUFFICIENTLY ASI-Pr 0004338 EXAMINATION - SAMUEL 3 S T E r'! - MR. VASSAL''"!'!'? STRONG STATEMENT -- INDICATING THAT PiOXMITT OF RESIDENTS TO CERTAIN INDUSTRY IS wHAT mE CALL IN THE TRADE A RISK FACTOR. IT PUTS TOU AT EXCESS RISK OF DEVELOPING CANCER. AND THE 9ASE FOR THIS STARTED IN -- WITH A PUBLICATION OF SOME MAPS 3Y THE NATIONAL CANCER INSTITUTE, WHICH SHOWED -- AND THESE WERE -- WOULD SHOW THAT IN CERTAIN PARTS OF THIS COUNTRY, YOU HAD HIGH LEVELS, LIVING ENCOUNTERS IN CERTAIN PARTS OF THIS THERE WERE VERY HIGH LEVELS OF CANCER AS COMPARED TO. OTHER PARTS OF THE COUNTRY. AND THESE AREAS WERE THE HIGHLY INDUSTRIALIZED NORTHEAST. ANO IT'S NOT OVERALL CANCER MORTALITY RATES, BUT ITS CANCcR FOR A WIDE RANGE OF SITES. AND THESE STUDIES HAVE BEEN AMPLIFIED AND VARIOUS STUDIES SHOWING AGAIN IN CERTAIN PARTS OF AMERICA, IN CERTAIN STATES IN CERTAIN COUNTIES, THERE ARE EXCESS RATES OF CANCER. BEFORE I GET INTO THAT AND IN SOME OF THESE INSTANCES, THERE HAVE 3 EEN WHAT WE CALL MONITORING STUDIES. THE AIR HAS 3EEN SAMPLED AND IT HAS BEEN SHOWN THAT THE INDUSTRIES CONCERNED IN THESE AREAS WHERE YOU HAVE HIGH LEVELS OF CANCER HAVE BEEN ASI-PR 0004339 EC EXAMINATION - SAMUEL EPSTEIN - .U. '/A S 5 ALO T T I 5 7 1 PUTTING OUT CHEMICALS, CARCINOGENS INTO THE 2 AIR OF THE LOCAL COMMUNITIES. 3 U T LET US 3 RETURN NOW TO THE ANGIOSARCOMA. 4 THERE ARE EIGHT -DOCUMENTED 5 CASES OF COMMUNITY ANGIOSARCOMA; THAT IS, 6 PEOPLE GETTING ANGlOSARCOMA, LIVING IN THE 7 VICINITY Or VINYL CHLORIDE 8 POLYVINYLCHLORIDE PLANT. EIGHT CASES, WITH 9 MR. G.RASSO, THAT'S NINE. LET'S TALK A30UT THE 10 EIGHT CASES FIRST. n IN 1574, CHRISTINE REPORTED 12 ANGIOSARCOMA OF THE LIVER IN S0ME300Y LIVING 13 TWO MILES AWAY FROM A POLYVINYL CHLORIDE 14 PLANT IN CONNECTICUT. AND THIS WAS A MAN OF 15 AGS -- WHO DIED AT THE AGE OF 75 AND HE 16 LIVED -- INCIDENTALLY, UE DIED IN 19*7. AND 17 HE LIVED TWO MILES AWAY FROM A'PLANT IN 18 CONNECTICUT. AND THIS PLANT WAS A FABRICATING 19 PLANT; THERERFORE, LESS LIKELY TO PUT OUT 20 LARGE CONCENTRATIONS OF PVC. IN THIS SAME 21 PLANT WHERE THIS MAN LIVED IN, THERE WAS 22 ANOTHER OCCUPATIONAL CASE OF ANGIOSARCOMA, A 23 WORKER IN THIS PLANT ALSO DIED OF 24 ANGIOSARCOMA. 25 CHRISTINE ALSO DESCRIBED ASI-PR 0004340 XAMINATIDN - SAMUEL EPSTEIN - M. V A S ? 4 LO T T I *? another CASE NEAR another plant IN CONNECTICUT. Q. DOCTOR, LET .ME INTERRUPT YOU FOR A SECOND. YOU'RE TALKING A30UT A REFERENCE TO CHRISTINE. IS THAT AN AUTHOR OF A MEDICAL ARTICLE? A ,, YES/ THAT'S AN AUTHOR 0* A SCIENTIFIC PUBLICATION WHICH I HAVE WITH ME AND CAN MAKE AVAILABLE. Q. BUT THESE ARE MATERIALS A. THIS IS PUBLISHED IN THE OPEN LITERATURE. THERE WERE EIGHT INDICATIONS 0* ANGIOSARCOMA PU3LISHE0 IN THE OPEN SCIENTIFIC LITERATURE AND LET ME, BEFORE GOING INTO THE DETAILS, MAKE TWO POINTS ABOUT THEM: THAT THESE PEOPLE ALL LIVED IN LESS THAN TWO MILES -- OF THESE EIGHT CASES, THEY ALL LIVED LESS THAN TWO MILES FROM THE PLANT -- FROM THE PLANT, AND IN TWO OF THESE CASES, THE LATENCY PERIOD WAS BRIEF, SIX YEARS IN ONE, LIKE MR. GRASSO^ AND EIGHT YEARS IN ANOTHER. Q. DOCTOR, WE'LL GET TO THE LATENCY PERIOD IN A MOMENT. RIGHT NOW LET'S TALK ABOUT THE EVIDENCE OF THE DEVELOPMENT OF ANGIOSARCOMA IN RELATIVELY LOW LEVELS OF ASI-pp 0004341 EC I ***! 7 1 '.jM -- Sx-'HuEL Si*S Fi IN - R. V -^ S m L - T I 1 * 3 I EXPOSURE? 2 A. WELL, WE'RE TALKING NOW ON HE THIN3 3 LINE OF EVIDENCE, NAMELY HE ACCOUNTS CF 4 ANGIOSARCOMAS IN COMMUNITY RESIDENTS, THIS 5 REPRESENTING The THIRD. LIME OF EVIDENCE FOR 6 THE ACCOUNTS OF ANGIOSARCOMAS AT LOW LEVELS 7 OF VINYL CHLORIDE EXPOSURE. I'VE ALREADY 3 MENTIONED TWO CASES. 9 THE THIRD CASE WAS DESCRIBED 10 3 Y 3AXTER IN' 1370,* A MAN OF A 1, WHO DIED IN tl 1370 WnO HAD LIVED FOR SIX YEARS NEAR A PLANT 12 AND IN THIS SAME PLANT WHICH HE LIVED NEAR, 13 THERE WAS ALSO A CASE OF A WORKER WHO OIED OF 14 ANGIOSARCOMA OF THE LIVER. 15 IN A PAPER 3 Y 3RADY IN l77, 16 THERE WERE A TOTAL OF FIVE CASES OF WOMEN WHO 17 LIVED CLOSE TO PLANT. THE FIRST ONE DIED IN 18 1 0 5 5 . SHE LIVED LESS THAN A MILE =<*OM A PLANT. 19 THE SECOND W.AS A WOMAN OF U5 WHO LIVED LESS 20 THAN A MILE FROM THE PLANT. THE THIRD WAS A 21 WOMAN OF 31 WHO LIVED A THIRD OF A MILE F*OM 22 THE PLANT. THE FOURTH WAS A WOMAN *QP 5 2 WHO * 23 LIVED A THIRD OF A MILE FROM THc PLANT. AND 24 The FIFTH WAS A WOMAN OF 31 WHO LIVED A30UT 25 POINT ONE MILES FROM A PLANT. I SHOULD ASI-PR 0004342 .> I RECT EXAM I NAT I ON SAMUEL EPSTEIN *3 ViSlAUCrr r 1 (?{} 1 mention that two of these case?, Tt*E raxt*? 2 CASE, LIVED SIX TEATS, 4D ONLY SIX YEA^S 3 EXPOSURE, WAS A SIX YEAR RESIDENT AND THE 4 3RAOY CASE WAS AN EIGHT YEAR RESIDENT. 5 NOW, IN ADDITION TO THE 6 ANGIOSARCOMAS OCCURRING AS A COMMUNITY CANCER, 7 .<' ALSO HAVE TwO OTHER KINDS -- WE ALSO 8 HAVE TWO OTHER REPORTS OF VINYL CHLORIDE 9 ASSOCIATED OR INDUCED CANCER IN COMMUNITY 10 RESIDENTS. AND THE PARTICULAR INTEREST OF n THESE IS AS FOLLOWS: THESE WERE RRAIN TUMORS. 12 NOW, WE <NQW THAT VINYL 13 CHLORIDE PRODUCES CANCER IN A WIDE RANGE OF 14 ORGANS AND VINYL CHLORIDE IS RECOGNIZED AY 15 THE INTERNATIONAL AGENCY FOR RESEARCH ON 16 CANCER AND VARIOUS OTHER GROUPS AS REING WHAT 17 We CALL a MULTI-SYSTEM CARCINOGEN -FOR 18 PRODUCING CANCER IN A WIDE-RANGE OF ORGANS, 19 ;>OT ONLY ANGIOSARCOMA OF THE LIVE* 3UT 20 PRODUCING CANCER OF THE LUNG, IN THE 3RAI-N 21 AND OTHER SITES. 22 NOW, IN THESE TWO-COMMUNItr 23 CANCERS I'M TALKING A30UT, NAMELY A StUqY 3Y 24 EANFANTI IN 1^75, AN EXCESS IN ERAIN TUMORS 25 WAS DEMONSTRATED IN RESIDENTS IN Ohio ASI-PR 0004343 X4M I NAT I C`4 - i4.'iuL EPSTEIN - MR. VASSALJTTIMl COrtrtU.il T 155 xHERE VC PVC PLANTS .-.EPS LOCATED. IN TrlE SAME YEAS, A S'T-JDY W AS -- A CANADIAN STUDY wAS PUBLISHED OF EXCESSIVE BRA IN TUMORS OF PEOPLE LIVING IN A CANADIAN COUNTY NEAR A VC PVC PLANT. THAT, VEPT BRIEFLY, IS THE EVIDENCE FOP THE CARCI NOGEN ICITY AT WAT MAYBE CALLED LOW LEVELS, although I WOULD PUT OUOTATION MARKS ABOUND THE WOPO LOW. 0. NOW, DOCTOR, IN DEALING WITH CANCSP CAUSING AGENTS LIKE VINYL CHLOPIDE,,. ThE TERM LATENCY PEPIOQ HAS COME UP IN THIS CASE AND YOU JUST MENTIONED IT TOURSELF. WHAT DOES LATENCY PERIOD MEAN? A. THE LATENCY PERIOD IS REALLY THE TIME FROM THE FIRST EXPOSURE TO A TOXIC OR CANCER CAUSING CHEMICAL TO THE DATE OF DIAGNOSIS OR DEATH FROM A PARTICULAR ADVERSE EFFECT. NOW, THERE APE OTHER WAYS OF DEFINING LATENCY PERIOD, PUT I THINK THIS IS PROBABLY, FOP THE CONTEXT -- = 0R OUP CONTEXT, PROBABLY THE MOST EFFECTIVE AND BEST DEFINITION.' Q. DOCTOR, HAS THE MEDICAL RESEARCH ^ITERATORS DETERMINED OR 3`JGGESTEO THAT A CERTAIN MINIMUM LATENCT PERIOD IS REQUIRED ASI-PR 0004344 EXAMINATION - SAMUEL EPSTEIN - M7. VA3SALOTTi10 1 F 0 3 THE DEVELOPMENT OF ANGIOSACCOMA IN 2 PERSONS EXOOSEO TO VINYL CHLORIDE? 3 A. WELL, IN GENERAL, I Thin* IT'S FA[7 4 TO SAY THAT THE AVERAGE LATENCY PERIOD IN Th 5 LITERATURE FOR ANGIOSARCOMA IS SOMEWHAT IN 6 THE RANGES OF ABOUT 20 YEARS, SOMEWHERE IN 7 THAT .< I NO Or 9ALLPARK, 20 YEARS. 8 HOWEVER, THERE ARE REPORTS, A 9 WIDE RANGE OF REPORTS, OF ANGIOSARCOMAS AND 10 OTHER VINYL CHLORIDE INDUCED CANCER WITH 11 LATENCIES UNDER TEN YEARS. 12 Q. YOU'VE ALREADY MENTIONED, I TKINK, 13 TWO OF THEM IN THE COMMUNITY CANCER CASES. 14 A. THAT IS CORRECT. LET MS JUST VERY t 15 3RIEFLY RUN THROUGH THESE TEN -- THESE 16 REPORTS ON VINYL CHLORIDE INDUCED CANCER, 17 ANGIOSARCOMAS, UNDER TEN YEARS. 18 0. AND AGAIN 9EFORE YOU START, THESE 19 REPORTS THAT YOU'LL 3E REFERRING TO ARE 20 MATERIALS THAT HAVE 3 E E N OUT IN THE PUBLIC 21 LITERATURE? 22 A. YES. IN 1975, THE ENVIRONMENTAL 23 PROTECTION AGENCY IN A PU3LIC DOCUMENT, 24 REFERRED TO TWO ANGIOSARCOMAS, ONE IN AN 25 ITALIAN WORKER, VINYL CHLORIDE WORKER, WHOSE ASI-PR 0004345 X AM I NAT ! ON - SAMUEL E ? 3 T E IN - MR . V A S 3 A L 2 T T I l:} LATENCY PERIOD *AS SIX YEARS, SIX YEARS, THE S A.iE AS MR. *j R A S S 0 ; THE SECOND *A3 AN ANGIOSARCOMA IN A BRITISH WORK WITH A LATENCY OF EIGHT YEARS. THE THIRD CASE IS CHRIST I NE ' S CASE IN 19 7 A; THAT IS, THE ACCOUNTANT WHO WORKED IN A FABRICATING L A N T WHO HAD A LATENCY OF TEN YEARS. THE NEXT IS A CASE I MENTIONED ALREADY, THE ANGIOSARCOMA OF THE LIVER, WHO HAD A LATENCY OF SIX YEARS. THIS WAS A RESIDENT WHO LIVED LESS THAN HALF A MILE FROM A VC PVC PLANT. THE NEXT CASE WAS AGAIN A LIVER CANCER WITH A LATENCY PERIOD OF EIGHT YEARS, PUBLISHED 3Y BRADY IN X977, WHO *AS A RESIDENT A THIRD OF A MILE AWAY FROM A VC PVC PLANT IN NEW YORK. OVER AND ABOVE THESE LIVER ANGIOSARCOMAS, THE LIVER CANCEP, WHICH IS* ANOTHER KINO OF MALIGNANCY OF THE LIVER WHICH IS different FROM angiosarcoma BUT IS lethal TODAY, WAS REPORTED IN A WORKER IN A BRITISH VC PVC PLANT WITH A LATENCY OF NINE YEARS, ANOTHER WAS IN THE SAME PAPER BY POX AND COLLIER, A CANCER OF THE LUNG IN A WORKER IN THE BRITISH1PLANT WITH A LATENCY OF NINE ASI-PR 0004346 EC EXA.i I nAT I ON - SAMUEL E P S T E l M - MS. V*S5AL0TTI I JA 1 YEARS. IM THE SAME A P E R , ALSO CANCER OF THE 2 PANCREAS IN LESS THAN TEN YEARS IN A W C R '< E R 3 IM A 9RITISH PLANT. FINALLY, TWO BRAIN 4 CANCERS, A 3RAIN CANCER IM A WORKER IN TMS 5 UNITED STATES, VINYL CHLORIDE WITH A LATENCY 6 OF THREE YEARS, WAXWEILLSR IN 1375. AMD 7 FINALLY, A WORKER IN A SWEDISH PLANT WITH A 8 LATENCY OF LESS THAN ONE YEAR. 9 Q. DOCTOR, HAS 3-RAlN CANCER BEEN LINKED 10 WITH VINYL CHLORIDE? 11 A.. IT MOST CERTAINLY HAS. 12 Q . DOCTOR, ARE YOU FAMILIAR WITH 13 AS A PHYSICIAN AND A RESEARCHER, ARE YOU 14 FAMILIAR WITH THE A3ILITY OF LUNGS TO 3 R E4 THE 15 IN PARTICLES OF VARIOUS SIZES? 16 A. YES, l WOULDN'T CLAIM PARTICULAR 17 EXPERTISE OF AREAS OF RESPIRATORY PHYSIOLOGY, 18 BUT I'M CONVERSANT WITH SOME ELEMENTS OF THE 19 FI ELD. 20 q. DOCTOR, IF A PERSON WAS EXPOSED TO 21 ATMOSPHERE HAVING WITHIN IT PVC DUST 22 PARTICLES WITHIN A SIZE RANGE OF ONE TO TEN 23 MICROnS -- DO YOU KNOW WHAT A MICRON IS? 24 A. YES. 25 Q. WOULD THOSE PARTICLES 3E RESPIRA3LE, ASI-PR 0004347 EXAMINATION - SA/UEL E 3 S ~ E IN - **R. V A 3 5 AL 0 T T I i .} s WGJLD THEY ENTER INTO A PERSONS LUNGS? A. SURE. THE SMALLER THE PARTICLE, CcRTAINuY, WHEN YOU REACH MORE THAN -- WHEN YOU REACH TEN MICRONS AND ABOVE, THE PARTICLES TEND TO 3E I RRESP l RA3LE. THE LOWER YOU GO, THE GREATER THE ABILITY OF THE LUNG TO RETAIN THESE PARTICLES, SO THE LOWER, THE SMALLER THE PARTtCLE, JUNK MORE RESPIRABLE IT IS WITHIN THIS RANGE. Q. AND WOULD They RE -- ONCE RESPtRABLE, WOULD THESE SMALL PARTICLES -- WOULD ANY OF THESE SMALL PARTICLES 9E SUBJECTED TO 9E RETAINED OR ENTRAPPED IN THE .LUNG? A. YES. AND THERE ARE VARIOUS STUDIES ON THE EFFECTS OF POLYVINYLCHLORIDE PARTICLES IN THE LUNG. THERE HAVE BEEN A WHOLE SERIES OF PUBLICATION SHOWING THAT POLYVINYLCHLORIDE CAN PRODUCE GRANULOMATOUS CHANGES IN THE LUNG AND THERE ARE VARIOUS PUBLICATIONS ON THE ABILITY OF PARTICLESS TO PRODUCE THESE CHANGES IN THE PARTS OUITE APART FROM INFORMATION THAT WE HAVE ON ITS CARCINOGENICITY, ON THE CARCINOGENIC EFFECTS OF POLYVINYLCHLORIDE. THE COURT: I THINK WE * L L ASI-PR 0004348 EC EXAM I .<AT I ON SAMUEL EPSTEIN MR. VAESALOTTI Id 1 T AXE OUR NOON RECESS, LAD I ES AND GENTLEMEN. 2 3 E 3 AC < HE P E AT 1:30. 3 CAT WHICH TIME THE JURY 4 LEAVES THE COURT- ROOM.). 5 THE COURT: WE WILL STAND IN 6 RECESS UNTIL 1:30 7 CLUNCHEON RECESS). 8 THE COURT: PLEASE CONTINUE. 9 10 YOJR HONOR. MR. VASSALOTTI: THAN< YOU, 11 3 Y MR. VASSALOTTI : 12 Q. DOCTOR, YOU WERE NOT IN THE COURT- 13 THIS MORNING WHEN I READ A HYPOTHETICAL FACT 14 SITUATION TO DOCTOR LAUCIUS, WERE YOU? 15 A. 16 Q. NO. OOCTOR, IN THAT CASE, I'LL HAVE TO 17 AS< YOU TO ASSUME THE FOLLOWING e A C T 5 WIT* 18 REGARD TO THIS CASE: CIRST THAT MR. JOHN 19 SRAS SO WAS 3CRN ON DECEMBER 27, 1P27 AND THAT 20 UP UNTIL HIS LAST ILLNESS IN MAT OF 107S, 21 there was no history, medical history of 22 CANCER OR LIVER DISEASE IN HR. GRASSO, AND 23 that also, there was no history of cancer or 24 LIVER DISEASE IN EITHER OF HIS PARENTS OR HIS 25 3ROTHERS OR 'SISTERS. I FURTHER AS< YOU TO ASI-PR 0004349 EC EXAMINATION - SAMUEL E P S t f I nj - MR . V A S S A L 3 T T I l 9 7 1 ASSUME THAT MR. GRASSO BESA'i WORKING AT THE 2 DUMONT C M A M 3 E R 5 w 0 R K S IN DEEPWATER, N E w JERSEY 3 IN APPROXIMATELY 19 4-7 A NO THAT EXCEPT FOR 4 PERIODS WHEN HE *AS LAID OFF FROM THAT 5 FACILITY, HE WORKED THERE UNTIL MAY OF 1975; 6 AND THAT IN THAT EMPLOYMENT AT THE DUPONT 7 chambersworks, he did not work with arsenic 8 OR ARSENIC COMPOUNDS OR WITH VINYL CHLORIDE. 9 DURING THE PERIODS THAT HE. WAS LAID OFF FROM 10 THE DUPONT CHAMBERSWORKS, HE HELD SUCH JOBS 11 AS WORKING AT AN GROCERY STORE, AN AUTO ARTS 12 SALESMAN, A GAS STATION ATTENDANT, A 13 CONSTRUCTION LA30RER, AN AUTO MECHANIC AND A 14 SHEET METAL WORKER. I ASK YOU TO FURTHER 15 ASSUME THAT DURING THE YEARS OF 1970 THROUGH 16 1975, MR. GRASSO WAS AWAY FROM HIS HOME 17 APPROXIMATELY 50 TO 55 HOURS PER WEEK; 18 therefore, he was at home or in the area of 19 HIS HOME APPROXIMATELY -- OR OVER 50 20 PERCENT OF THE TIME DURING THOSE YEARS. 21 IN ADDITION, I ASK YOU TO 22 ASSUME THAT -IN FEBRUARY QP 19 -- BETWEEN 23 FEBRUARY OF 1973 AND SEPTEMBER OF 1"73, *R. 24 GRASSO WAS AT HOME VIRTUALLY ALL THE TIME, AS 25 HE WAS RECUPERATING FROM CORONARY ARTERY ASI-PR 0004350  C A M l N A T I 0 N - SA.-iocL EPSTEIN - MR. VA S S ALG T T l I 3 5 1 BYPASS SURGERY.' 1 F JR THER AS< YOJ TO ASSUME 2 THAT DURING THE PERIOD OF MARCH CF 19 7G 3 THROUGh DECEMBER, 1975, MR. GRA530 LIVED 4 APPROXIMATELY ONE POINT SEVEN MILES FROM A 5 PVC PRODUCTION PLANT OWNED AND OPERATED *Y 6 THE A.F. GOODRICH COMPANY. DURING THOSE YEARS, 7 IT HAS BEEN ESTIMATED THAT Tat PVC PLANT 8 EMITTED BETWEEN THE ONE POINT POUR AND FOUR 9 POINT THREE POUNDS OF VINYL CHLORIDE INTO THE 10 ATMOSPHERE. AND IT`S SEEN FURTHER ESTIMATED 11 THAT DURING THOSE YEARS THAT ThE PVC PLANT 12 ALSO EMITTED INTO THE ATMOSPHERE AMOUNTS OF 13 PVC DUST PARTICLES THAT RANGED IN SIZE 14 BETWEEN ONE AND TEN MICRONS AND THAT SUCH PVC 15 DUST PARTICLES CONTAINED ENTRAPPED UNREACTED 16 VINYL CHLORIDE IN LEVELS RANGING FROM 40 17 PARTS PER MILLION UP TO 2,000 PARTS PER 18 MILLION. 19 IT HAS BEEN FURTHER ESTIMATED 20 THAT OURING THE YEARS 1970 THROUGH 1975, That 21 there EXISTED LEVELS OF VINYL chloride IN THE 22 AIR AND AROUND THE GRASSO HOME AND THAT THOSE 23 LEVELS HAVE BEEN ESTIMATED TO RANGE FROM ONE 24 POINT ONE PARTS PER MILLION TO 28 PARTS PER 25 MILLION, AND THAT THESE LEVELS OF VINYL ASI-PR 0004351 EXAMINATION - SAMUEL EPSTEIN - M=. VASSALOT"!10 1 CHLORIDE AT OR ABOUND THE GROSSO HOME V/FRE 2 PRESENT FOR A TOTAL Op 1 , 5 3 * HOURS OF 3 CONDITIONS WHEN THE WIND WAS FAVORABLE TO 4 3RING THOSE MATERIALS THERE DURING THE TEARS 5 IN QUESTION. 6 FURTHER, ON -- IN HAZE OR 7 POLLUTION CONDITIONS, THE LEVEL OF EXPOSURE 8 AT THE GRASSO HOME RANGED AS HIGH AS FROM TEN 9 TO 90 PARTS PER MILLION. 10 FINALLY, DOCTOR, IN ADDITION 11 TO THOSE EXPOSURES OR THOSE LEVELS OF 12 EXPOSURE AT THE AREA OF THE GRASSO HOMS, 13 THERE WERE IN ADDITION SHORT PERIODS OF TIME 14 DURING THE YEARS IN QUESTION RANGING ANYWHERE 15 FROM FIVE TO 15 MINUTES DURING WHICH IT HAS 16 SEEN ESTIMATED THAT LEVELS OF VINYL CHLORIDE' 17 EXPOSURE IN THE AREA OF THE GRASSO HOME 18 RANGED AS HIGH AS SEVERAL HUNDRED PARTS 3 E R 19 MILLION. 20 NOW, DOCTOR, 3ASED UPON THAT 21 INFORMATION, AND 3AS ED UPON TOUR EXPERIENCE 22 AS A PHYSICIAN AND A TOXOCOLOGI ST, AND YOUR 23 KNOWLEDGE OF THE LITERATURE AMO MEDICAL 24 EVIDENCE IN THE AREA OF CANCER AMD CANCER 25 CAUSING CHEMICALS, DO YOU HAVE AN 0 IN ION AS ASI-PR 0004352 EC' examination - Samuel epstein - 1 vassalg r r 111 a 1 TO rt.-iAT CAUSED THE A NG I 0 S A RC G MA OF THE LIVER 2 THAT HR. JOHN GRASSO HAD? 3 A. 4 q. rE S . AND WHAT IS YOUR. OP INIQN, DOCTOR? 5 A. MY OPINION IS THAT THERE * S A 6 SUBSTANTIAL PROBABILITY THAT IS HIS 7 ANGIOSARCOMA WAS DUE TO RESIDENTIAL EXPOSURE 3 TO VINYL CHLORIDE EMITTED FBQM THE B.F. 9 GOODRICH PLANT. 10 Q. DOCTOR, WHY DION'T ANY3QQY ELSE IN 11 THE GRASSO FAMILY GET THE ANGIOSARCOMA OF THE 12 LI V E R ? 13 A. WELL, I HAVE THREE RESPONSIVE 14 COMMENTS: FIRST OF ALL, I BELIEVE ON THE 15 BASIS OF THE EXPOSURE DATA THAT WE HAVE, THAT 16 THE GRASSO FAMILY IS AT RISK AND WHILE NOBODY. 17 IN THAT FAMILY HAS DEVELOPED CANCER SO FAR, I '18 BELIEVE THAT THE FAMILY IS AT RISK AND 19 THEREFORE ONE CAN'T ANSWER THAT QUESTION 20 UNTIL THE REST OF THE FAMILY AND LOCAL 21 RESIDENTS HAVE BEEN FOLLOWED UP FOR LIFETIME, 22 POINT ONE. - 23 POINT TWO, MR. GRASSO MAY 24 wElL -- AND I V; NOT PREPARED TO EXCLUDE THE 25 POSSIBILITY -- MAY WELL HAVE 3EEN ASI-PR 0004353 DIRECT EXAMINATION - SAMUEL EP5TSIN - Ml. VASSALCTTI1I1 1 SENSITIZED TO THE VINYL CHLORIDE 9Y OT^R 2 EXPOSURES, S'JCH AS CHEMICALS, A WIDE RANGE QP 3 CHEMICALS, NON-CARC I NOGENIC AMD CARCINOGENIC 4 WHICH HE HANDLED WHILE WORKING AT DUPONT. 5 ANO THIRDLY, IN ANY 6 POPULATION OF ANIMALS OR HUMANS WHO ARE 7 EXPOSED, THERE IS A DISTRl3UTI 0N, WHAT Wc * 8 CALL A GAUSSIAN, TYPE OF 0 I STRI 3UTI ON OF 9 SENSITIVITY. SOME INDIVIDUALS FOR GENETIC AND 10 OTHER REASONS HAVE HIGH SENSITIVITY; SOME 11 INDIVIDUALS ARE THE OTHER KIND -- END OF IT, 12 HAVE A LOW SENSITIVITY AND SOME HAVE 13 INTERMEDIATE SENSITIVITY. THIS IS A \ 14 CHARACTER IC, RIOLOGICAL SENSE, WHEN YOU TAKE 15 ANY POPULATION, RATS, HUMANS, THE SENSITIVITY 16 IS -- SOME ARE VERY SENSITIVE, SOME 17 RESISTANT, SOME INTERMEDIATE. AND IT MAT WELL 18 3c THAT MR. GRASSO FELL INTO THE -- THE END 19 UF THE SPECTRUM, REPRESENTING THOSE WHO, FOR 20 GENETIC AND OTHER REASONS, ARE MORE SENSITIVE 21 THAN OTHERS. 22 MR. VASSALOTTI: THANK YOU, 23 DOCTOR, NO FURTHER QUESTIONS, YOUR HONOR. 24 THE COURT: CROSS-EXAMINE 25 CROSS EXAMINATION 0004354 ASl'P* c to 3 5 DR. EPSTEIN 9ENNE I S E N 112 1 3T MR, icNNc!SEN : 2 Q. DOCTOR EPSTEIN, YOU USED TERM 3 SUBSTANTIAL PROBABILITY. WHAT 00 YOU MEAN BY 4 SUBSTANTIAL PROBABILITY? 5 A. I THINK THE TERMS ARE 6 SELF-EXPLANATORY, BUT I'M WlLLtNG TO OFFER 7 YOU SYNONYMS FOR SUBSTANTIAL ANO SYNONYMS -OR 8 PROBABILITY, IF THIS IS WHAT YOU WISH. 9 0. IN OTHER WORDS, IT SHOULD BE 10 INTERPRETED without any MEDICAL SIGNIFICANCE? 11 IT'S SIMPLY WHAT THE WORDS MEAN IN AN 12 ORDINARY DICTIONARY MEANING; IS THAT CORRECT? 13 A. NO. IT IS A STATEMENT OF -- MY 14 MEDICAL AND SCIENTIFIC OPINION THAT THERE IS 15 A SUBSTANTIAL PROBABILITY THAT HIS 16 ANGIOSARCOMA WAS DUE TO RESIDENTIAL EXPOSURE. 17 Q. I UNDERSTAND YOU'VE SAID THAT, 18 DOCTOR. * 19 CAN YOU EXAND UPON THAT AND 20 EXPLAIN WHAT YOU MEAN? 21 A. CERTAINLY. I THINK THAT SCIENCE 22 Q. PROBABILITY MEANS MORE LIKELY THAN 23 NOT, DOES IT NOT? 24 A. YES. MEDICAL SCIENCE IS UNABLE IN 25 ANY PARTICULAR CASE OF AN ADVERSE EFFECT TO ASI-PR 0004355 s - OR. EPSTEIN - MR. R E N N E I SEN 113 TAL< Pi A3S0UUTE TERMS. ONE CAN ONLY DEVELOP POSITIONS, I NFERENT I ALLY AND ON THE BASIS 0" P308A3ILITIES. WITH VERY RARE EXCEPTION I'M GOING TO GIVE YOU AN EXCEPTION IN A MOMENT -- THERE IS NO SINGLE ONE CAUSE FOR ANY ONE DISEASE AND YOU CAN'T NECESSARILY IN ArtY 0\E CASE TAL< ABOUT ABSOLUTE CAUSALITY. YOU CAN'T SAY, "I'M 1U0 PERCENT CERTAIN," OR IF SOMEBODY SAYS THEY'RE 100 PERCENT CERTAIN, THEY'RE ON S H A < Y SCIENTIFIC GROUNDS. THERE ARE CERTAIN KINDS OF CANCERS MESOTHELIOMA THAT -- A CANCER INDUCED 3Y ASBESTOS WHICH FOR ALL INTENTS AND PURPOSES, HAS NEVER ALTHOUGH THEY HAVE -- IT IS DANGEROUS AT -- HAS NEVER, IF AT ALL BEEN INOUCEO RY .AGENTS OTHER than ASBESTOS. THEREFORE, IF WE WERE TALK A30UT MESOTHELIOMA, THE LIKLIHCOO IS ONE WOULD TALK tN MORE ABSOLUTE TERMS. BUT IN A CASE LIKE THIS, I THINK THAT IT IS SCIENTIFICALLY APPROPRIATE TO TALK ABOUT THE MOST LIKELY AND THE MOST PR03A8LE. A-NO THE TERM SUBSTANTIAL PROBABILITY REALLY EXPRESSES WHAT ARE THE MOST LIKELY EXPLANATIONS FOR THtS CONDITION. 0. THANK YOU, DOCTOR. NOW, WITH RESPECT ASI-PR 0004356 0 R . P S T E I \ - MR . R E N N E I S = \* t TO ANGIOSARCOMA, I BELIEVE YOU HAVE ALREADY TOLO J 5 THAT THERE ARE FOUR AGENTS OR CHEMICALS THAT HAVE BEEN IDENTIFIES TO DATE AS CAUSATIVE -- AS AGENTS WHICH WILL CAUSE ANGIOSARCOMA. A. WELL, I'M NOT A9 SOLUTELY -- JUST ONE SLIGHT CAVEAT IF I MAT. WHEN IT COMES TO THE ANABOLIC STEROIDS, I DON'T THINK ONE CAN DEFINITELY INCRIMINATE THOSE. ONE CAN TALK ABOUT PROBABILITY. THE AUTHORS OF THE PAPER, FAULK ET AL WERE VERY CAUTIOUS ABOUT THIS. THEY DIDN'T INCRIMINATE THEM UNEQUIVOCALLY IN THE SAME SENSE THAT VINYL CHLORIDE IS INCRIMINATED. THEY TALKED ABOUT PROBABILITY AND TO USE THE LANGUAGE, IF YOU WISH ME TO quote from the language they used -- they SAY IT IS SUGGESTED THAT LONG TERM ANABOLIC STEROIDS IS THE FORTH CAUSE AGAIN. THE SUGGESTED ASSOCIATION WITH THE ANASOL IC STEROIDS AND ANGIOSARCOMA REMAIN TO BE CONFIRMED.' I THINK WHAT WE CAN S*Y IS THERE ARE THREE CLEARCUT CAUSES AND A FOURTH Q. AND A ossible fourth? A. AND A POSSI3LE FOURTH WHICH IS ASI-PR 0004357 CRQ55 JR. EPSTEIN MR. REN.NEISEN l15 1 PR03LEMA7 ICAL, POSSIBLE. 2 Q. THE ARTICLE BY HENRY FAULK ANO HIS 3 ASSOCIATES YOU'RE REFERRING TC, IS THAT THE 4 . ARTICLE IN THE LANCET, IS IT NOT, NOVEMBER 24, 3 1979? 6 A. YES.' 7 Q. IS ITTRUE, DOCTOR, THAT IN THAT 8 ARTICLE, THEY ID\ ENTIFY APPROXIMATELY 25 9 PERCENT OF THE CASES WHICH HAVE CAUSES? 10 A. THAT'S RIGHT, YES. 11 Q. WHICH WOULD MEAN 75 PERCENT OF THE 12 CASES HAVE NOT YET 3EEN I DENT I FI ED AS HAVING 13 14 I A CAUSE? A. WELL, THAT'S A VERY INTERESTING 15 POINT, BECAUSE THAT'S NOT EXACTLY WHAT THEY 16 SAY. 17 Q. 18 A. WELL, LET'S LOOK LET ME JUST COMPLETE MYANSWER. WHAT 19 THEY SAY IS AS FOLLOWS: THEY SAY THATOF THE 20 CASES DESCRIBED SOMETIME -- NAMELY SSTwEEN 21 34 AND 74 -- THESE ARE THE ONLY RECORDED 22 CAUSES. THEY DON'T SAT THEY ARE THE ONLY 23 NECESSARY CAUSES. IN FACT, THEY GO TO POINT 24 OUT AT THE END OF THE ARTICLE 25 Q. SUPPOSE ASI-pR 0004358 55 DR. EPSTEIN 19 9 ENNE f 5 EN 11 A. THE LAST SENTENCE 9EAOS . THE CO'JRT: LET THE DOCTOR FINISH. YOU STARTED THE LINE OF QUESTIONING. THE WITNESS: THE LAST SENTENCE READS: "THE MOST IMPORTANT PURPOSE IN CALLING ATTENTION TO THIS RANGE OF CONDITIONS IS TO ENCOURAGE THE SEARCH OR ETIOLOGIC FACTOR ENQOGONOUS, MEDICAL AND ENVIROHENTAL AND INDUSTRIAL, WHICH ARE RESPONSIBLE FOR THE CASE CONSIDERED SO FAR TO 3E IDIOPATHIC." 3Y IDIOPATHIC, ONE MEANS THE CASES FOR WHICH THERE IS NO KNOWN RECORDED ETIOLOGY. SO THE AUTHORS OF THIS PAPER SAY, we SHOULD LOOK A GREAT DEAL BETTER THAN WE* REALLY HAVE FOR CAUSES, FOR ANGIOSARCOMA WHICH UP TILL NOW HAVE SEEN REGARDED AS IDIOPATHIC. AND, IN FACT, .THERE IS A SUBSEQUENT LITERATURE, THE ARTICLE 9Y BRADY, MAKES IT VERY CLEAR THAT THE -- THERE ARE MORE KNOWN CAUSES -- OR AS MANY KNOWN * CAUSES OF ANGIOSARCOMA AS THERE ARE UNKNOWN CAUSES. - Q. WOULD YOU READ THE FIRST SENTENCE OF THE SUMMARY POR ME,. PLEASE? A. CERTAINLY. ASI-pr OO04359 CRJ 55 D R . t P 5 T IN HR. RENNEISeN I 17 1 Q. THE VERY FIRST SENTENCE IN THE 2 ART I CLE . 3 A. A .RETROSPECTIVE 4 EPIDEMIOLOGICAL STUDY OF DEATHS FROM HAPATIC 5 ANGIOSARCOMA HAS IN THE U. S. SHOWED DURING 6 1954-74 THERE WERE IS? SUCH CASE, OF WHICH 7 3 7-, 22 PER CENT, WERE ASSOCIATED WITH 3 PREVIOUSLY KNOWN CAUSES, VINYL CHLORIDE, 9 THOROTRAST AND INORGANIC ARSENIC AND FOUR, 10 THREE POINT ONE PERCENT, OF THE REMAINING 131 11 CASES WITH THE USE OF ANDROGEN IC-ANA30LIC 12 STEROIDS. 13 Q. AM I CORRECT, DOCTOR IN 14 UNDERSTAND ING THERE IS NO DISCUSSION OF THE 15 CAUSE OF THE OTHER 75 PERCENT? 16 A. THAT * S * NOT MY POINT. MY POINT IS 17 THAT THEY CONCLUDE THAT FOR THE OTHER CASES, 18 WE SHOULD LOOK FOR THE CAUSES AND THAT 19 LET ME REPEAT AGAIN. THAT WE SHOULD LOOK 20 THE MOST IMPORTANT PURPOSE,- THE BOTTOM LINE 21 OF THE ARTICLE -- AND I REMEMBER -- THE 22 MOST IMPORTANT PURPOSE IN CALLING ATTENTION 23 TO THIS RANGE OF CONDITIONS IS TO ENCOURAGE 24 THE SEARCH FOR THE ETICLOGIC FACTORS, 25 ENVIROMENTAL, INDUSTRIAL, ENDOGONOUS AND ASI-PR 0004360 ss 01. EPSTEIN MR R E'JNE I SEN 11* medical, which a9E RESPONSIBLE FOP the CASES CONSIDERED SO FAR TO BE IDIOPATHIC. FOR THE CASES WHICH UP TO NOW WHICH HAVE SEEN CONSIDERED TO HAVE NO CAUSE. HIS POINT IS FOR THESE REGAINING CASES,. WE SHOULD TRY TO FIND THE CAUSE, SUCH AS COMMUNITY RESIDENCES, WHICH TILL RELATIVELY RECENTLY, HAVEN'T 3EEN WELL DOCUMENTED. Q. WOULD THE COURT REPORTER READ BACK MY QUESTION, PLEASE?.I DON'T THINK IT WAS ANSWERED. IF IT HAS SEEN, I'LL APPOLOGIZE. 3 UT I'D LIKE T*E QUESTION READ 3ACK. THE COURT: READ RACK THE QUESTION. (QUESTION READ). 3 Y MR. RENNEISEN: Q. CAN YOU ANSWER THAT QUESTION YES OR *0, DOCTOR? A. THE ANSWER IS, THERE IS A DISCUSSION. Q. THERE IS A DISCUSSION? A. YES. Q. A-ND IS YOUR -- THE ANSWER YOU'VE JUST GIVEN ME, THE DISCUSSION THAT EXISTS? A. ' THAT ISTHE BOTTOM LINE OF THE ARTICLE, YES; THERE ARE OTHER REFERENCES TO ASI-PR 0004361 C A ;s - dr EPSTEIN HR. ? c N \ c I 5 : N 11 5 1 THIS PR05LEM THROUGHOUT THE PAPER. BUT THE 2 I REPEAT, IT SAYS THE MOST IMPORTANT 3 PURPOSE. THE PAPER SAYS THE MOST IMPORTANT 4 PURPOSE 15 TO LOOK FOR CAUSES FOR THOSE 5 ANGIOSARCOMAS WHICH UP TILL NOW HAVE SEEN 6 CONSIDERED NOT TO HAVE A CAUSE. THAT IS WHAT 7 THE PAPERS SAYS. 8 0. THE PAPER SAYS LOOK eOR CAUSES. DOES 9 THE PAPER DISCUSS POSSIBLE OTHER CAUSES? 10 A. NO. IT DOESNT. 3ECAUSE WE HAVE A 11 RANGE OF CAUSES, FOUR CAUSES, AND IN THESE 12 154 CASES, WHAT HAVE YOU, IT IS IMPORTANT 13 THAT EACH OF THEM SHOULD BE CAREFULLY SERCHED 14 TO EXAMINE FOR THE POSSIBILITY Or EXPOSURE TO IS THESE AGENTS. AND IN THE LITERATURE tN THE 16 PAST, THERE HASN'T 3EEN DOCUMENTATION OF SUCH 17 EXPOSURES. IN THE SAME WAY AS SOME OF THE 18 COMMUNITY CANCER CASES HAVEN'T BEEN 19 RECOGNIZED IN THE PAST AS BEING DUE TO 20 ANGIOSARCOMA. AND THIS ISTHE POINT OF THE' 21 PAPER. IN CASES WHICH ARE CONSIDERED NOT TO 22 HAVE A CAUE, LOOK FOR THE CAUSES, LOOK AND 23 SEE IF THEY LIVE CLOSE TO A PLANT, LOOK AND 24 SEE IF THEY WORK IN A PVC FABRICATION PLANT, 25 LOOK FOR THESE CAUSES ASX"PR 0004362 DP. EPSTEIN MP . REHNEISEM 120 0. PRESENTLY DOCTOR, APE THE PE CASES FOP WHICH CAUSES APE UNATTR IP'JTAqLE CDP THE CENTER OF DISEASE CONTROL AND HEN P Y FAUL< 4 ND IS -A. MOST CERTAINLY. U. AND CURRENTLY, IS THAT A30UT-75 PERCENT OF THE TOTAL NUMBER OF CASES? A. I WOULDN'T AGREE WITH THAT FIGURE AND LET ME GIVE YOU THE REASONS FOR NOT AGREEING. LET US TURN TO THE COURT: LET ME SAT THIS, DOCTOR: 00 YOU WANT HIM TO CO-NT I NL'E ' ON . MR. penneisem: NO, SIR, RUT EVERYTIME I CUT HIM OFF, YOUR HONOR,. I*VE SEEN THE COURT: THIS SHOULD BE MOPE OF A QUESTION AND ANSWER. HE'LL ASK THE QUESTION. I'VE GIVEN YOU BROAD LATTITUDE. 3JT REMEMBER, HE'S QUESTIONING YOU AND YOU'LL RESPOND TO HIS ANSWERS. WHEN IT COMES 3AC.< FOR REDIRECT, IF THERE'S SOMETHING THAT COUNSEL FOR THE PLAINTIFF WANTS TO GET OUT OF YOU, HE'LL GET OUT OF YOU. BUT, 00 IT SY CUESTION AND ANSWER AND SORT OF STAY AWAY ASI-PR 0004363 c.r S - 02. EPSTEIN - .12. RENNEISEN 12 1 1 FROM THE VOLUNTEER ING. 50 AHEAD. 2 HR. renneisen: WHAT WAS MY 3 LAST QUESTION? 4 (DESIGNATED QUESTION IS READ.) 5 BY MR. RENNEISEN: 6 Q. SO, DOCTOR, I WAS 4SKING YOU AT THE * # 7 PRESENT TIME, ARE APPROX I M A T e L Y 75 PERCENT OF I 8 THE TOTAL CASES OF ANGIOSARCOMA ATTRIBUTED BY 9 THE CENTER FOR DISEASE CONTROL TO UNKNOWN 10 CAUSES? 11 A. YES. 12 Q . THANK YOU. 13 Q. DOCTOR, WHEN YOU TESTIFIED 14 CONCERNING YOUR QUALIFICATIONS, YOU GAVE US A 15 GREAT DEAL Oc BACKGROUND ABOUT YOURSELF. HAVE 16 YOU DONE ANY ANIMAL STUDIES YOURSELF WITH 17 RESPECT TO VINYL CHLORIDE? 18 A. I'VE DONE NO CARCINOGENICITY STUDIES. 19 I DID SOME MUTAGENICITY STUDIES ABOUT TEN 20 YEARS AGO, BUT I'VE DONE NO CARCINOGENIC ITY 21 STUDIES WITH THE WITH IT. 22 Q. YOU TESTIFIED THIS MORNING THAT 23 ANGIOSARCOMA IS A VERY RARE FORM OF LIVER 24 CANCER. HOW MANY CASES CAN WE EXPECT A YEAR 25 IN THE ENTIRE COUNTRY; 00 YOU KNOW, DOCTOR? ASl~pR 043i$4 - DR. EPSTEIN - MR. R5NNE1SEN 12? A. WELL, THERE HAVE SEEM VARYING ESTIMATES ON THIS, SOMEWHERE IN THE RANGES OF A30UT 25 TO 30 A YEAR, SOMEWHERE IN THAT RALL PARK. THAT WAS A-C.D.C. ESTIMATE OF A FEW YEARS AGO. Q. IN TALKING ABOUT THE HISTORY OF THE LITERATURE SHOWING INFORMATION ABOUT VINYL CHLORIDE, YOU, I BELIEVE, SAIO THAT BACK IN AROUND 1330, IT WAS FOUND THAT CONCENTRATIONS OF FIVE PERCENT PRODUCED ACUTE TOXICITY IN ANIMALS. FIVE PERCENT IS HOW MANY PARTS PER MILLION? A. P. P.M.. IT'S VERY HIGH, ABOUT 50 THOUSAND, Q. AND NATIONALS HIGHER THAN IT IS EXPLOSIVE LIMIT? A. OH, YES, VERY HIGH CONCENTRATIONS* INDEED. Q. AND AT THAT LEVEL, IT WOULD MAKE :AM ANIMAL UNCONSCIOUS POS3I3LY? A. SURE, ABSOLUTELY. Q. AND NOBODY -- NOBODY EVER WORKED IN LEVELS THAT HIGH, DID THEY? A. THERE HAVE BEEN RECORDED HIGH LEVELS IN AUTOCLAVES. I CAN'T RECALL THE EXACT ASI-PR 0004365 CRQ 5 S DR. EPSTEIN MR. RSNNSISEN 123 1 LEVELS, BUT I WOULD 4SREE WITH YOU THAT IN 2 ALL PROBABILITY, THIS IS AM EXTRAORDINARY 3 HIGH LEVEL, WHICH PROBABLY ISN'T COMMONLY 4 FOUND IN THE WORK PLACE. 5 Q. AND IF SOMEBODY STRUCK A MATCH IN 6 THAT LEVEL, BOOM, IT WOULD GO OFF, RIGHT? 7 A.- IT WOULD GO OFF, SURE. 8 Q. IN YOUR REVIEW OF THE LITERATURE 9 AND I THINK YOU SAID IT WAS MOSTLY 10 EUROPEAN LITERATURE -- TALKING ABOUT 11 TOXICITY, YOU DIDN'T FIND ANY REFERENCE TO 12 ANGIOSARCOMA, DID YOU, ABOUT THE PERIOD FROM 13 1949'TO 1970? 14 A. TO -- I MISSED ~ 15 Q. IN THE PERIOD FROM 1945 UNTIL VIOLA 16 IN 1970 -- 17 A. THAT'S RIGHT. 18 Q. THERE WAS NO REFERENCE TO 19 A. CORRECT 20 Q. -- AN G I OSARCOMA. 21 NOW, I THINK YOU HAVE SAID 22 THAT THAT LITERATURE WAS AVAILABLE AND COULD 23 BE READ BY ANYONE WHO WAS INTERESTED IF they 24 DID A LITERATURE SEARCH; IS THAT CORRECT? 25 A. YES. 0004366 ASI-PR crd SS - U R . EPSTEIN HR. REMNEIStN 1 2L 1 Q. WERE YOU FAMILIAR WITH THE 2 LITERATURE BEFORE 1970? 3 A. 4 q. 5 A. OF VINYL CHLORIOE? YES. I DON'T THINK SO. UT THEN IDIDN'T 6 HAVE RESPONSIBILITIES IN THE AREA. 7 Q.- YOU WERE IN THE ENVIRONMENTAL AREA AT 8 THAT TIME, WERE YOU NOT? 9 A. YES. I I WAS INTERESTED IN THOUSANDS 10 OF CHEMICALS. 11 Q. ALL RIGHT. DOCTOR, IS IT TRUE THAT 12 THERE WAS A PERIOD OF TIME -- I BELIEVE IT 13 WAS IN 1 9 5 0 * S BUT IT MAT HAVE BEEN IN THE 14 I96 0 ' S -- WHEN BECAUSE OF ITS NARCOTIC 15 EFFECT, VINYL CHLORIDE WAS -- NAS 16 EXPERIMENTED WITH BY THE MEDICAL PROFESSION 17 AS AN ANESTHETIC? 18 A. ABSOLUTELY. 19 Q. I KNOW THAT STUDY WAS ABANDONED, 3UT 20 IT DIDN'T PRODUCE ANY CANCER .RESULTS THAT 21 ANYBODY KNOWS ABOUT, DOES IT? 22 A. I'HAVE NO IDEA WHETHER THE PEOPLE 23 HAVE BEEN FOLLOWED UP. I JUST HAVE NO IDEA. I 24 THINK IT WOULD BE AN INTERESTING THING TO DO. 25 THAT MAY BE ONE OF THE UNEXPLAINED CAUSES OF ASI-pr 0004367 C R 'i 5S - OR EPSTEIN - RE HNS I SEN 1?* 1 angiosarcoma. 2 Q. IT DIDN'T PRODUCE -- W-*EN THE 3 EXPERIMENT TO USE IT AS AN ANESTHETIC STOPPED, 4 THERE WERE NO ACCOMPANING PAPERS DISCUSSING 5 CANCER, WERE THEY? 6 A. I DON'T THINK -- I DON'T THINK 7 these papers have been followed up. i think 8 IT'S AN EXCELLENT IDEA TO FOLLOW THEM UP TO 9 SEE HOW MANY OF THEM HAVE GOT ANGIOSARCOMA OR 10 IF ANY HAVE. SPLENDID CONCEPT. 11 Q. YOU MENTIONED THAT PRIOR TO 171, 12 THERE WERE EIGHT CASES Oc ANGIOSARCOMA IN 13 VINYL CHLORIDE WORKERS. 14 WHEN DID THAT KNOWLEDGE 15 artEN WAS THAT KNOWLEDGE COLLECTED? 16 A. WELL, IT IS IT CAME IN TWO STAGES: >7 FIRST OF ALL, THESE WORKERS WERE KNOWN TQ IB HAVE DIED FROM CANCER OF THE LIVER. HOWEVER, W Tnc DIAGNOSIS OF ANGIOSARCOMA WAS ONLY MADE 20 AFTER THE 3.F. GOODRICH ANNOUNCEMENT IN 21 JANUARY, 74, THAT SOME OF ITS WORKERS HAD 22 DIED OF ANGIOSARCOMA AND THIS WAS FIVE YEARS 23 AFTER THE VIOLA PUBLICATION OF THE 24 CARCINOGENICITY IF YOU RECALL. AND THE 25 REFERENCE TO THE -- THESE ANGIOSARCOMAS IS ASI-PR 0004368 SS OR. EPSTEIN - M". RENNEISEN 127 1 A LITTLE MIXEO U? ON HIS OATES 2 HIS FIRST STUDIES WERE 1972. 3 HIS FIRST 3TUDIE5 WERE DISCUSSED IN A PAPER 4 PRESENTED IN 1972; IS THAT CORRECT? 5 A. NO, SIR, NO, NO, NOT AT ALL. 6 MATALONI STARTED -- AFTER 7 VIOLA'S PUBLICATION AND PRESENTATION, 8 MATALONI WAS GIVEN A CONTRACT TO CONFIRM ANO 9 EXTEND THE FINDINGS. 3Y OCTOBER OF 1972, HE 10 HAD CONFIRMED A CARCINOGENICITY ANO EXTENDED, 11 HAD GONE TO MUCH LOWER DOSES. THREE MONTHS 12 AFTER THAT, THIS INFORMATION WAS PASSED ON TO 13 THE MANUFACTURING CHEMISTS ASSOCIATION. 14 0. EXCUSE ME? 15 A. 3UT. 16 THE COURT: JUST A MOMENT. 17 MR. RENNEISEN: I DON'T T HIN < 18 I ASKED HIM THAT. I ASKED HIM wMAT DATE 19 THE WITNESS: I'M GOING TO 20 TELL YOU. 21 3 Y MR. RENNEISEN: 22 Q. LET ME ASK YOU FIRST OF ALL, ARE WE 23 CORRECT IN UNDERSTANDING THAT HIS STUDIES 24 WERE IN SOME SENSE COMPLETED IN OCTOBER OF 25 19 7 2? ASI-pr 0004369 C} 55 - EPsTcIN MR. ilc'iNc l 5EN' I2* I NO, SIR, THAT'S NOT >4 HAT I SAID. 2 Q. WELL, WHEN WERE THEY COMPLETED? 3 A. LET ME ANSWER YOU, IF I MAY 4 HE STARTED A SERIES OF 5 ONGOING STUDIES IN ABOUT -- WITHIN SIX TQ 9 6 MONTHS OF VIOLA'S COMMUNICATION. 3Y l?7 2, IN 7 THE ONGOING STUDIES, HE HAD DEMONSTRATED THE 8 CARCINOGENIC EFFECTS OF VINYL CHLORIDE AND 9 HAD EXTENDED VIOLA'S INDEPENDENT FINDINGS. 10 THE FIRST STATEMENT OF THIS CAME -- WAS 11 RELEASED IN JANUARY, 1974 ON THE SAME DAY AS 12 3.F. GOODRICH AND ANGUNCED THE DEATH FROM 13 hMG10SARCOMA. THE FIRST PUBLICATION OF 14 MATALONI CAME SUBSEQUENT TO THAT. SO, AFTER 15 74. 16 Q. I'M SORRY, OKAY . 17 NOW, WHAT LEVELS WAS HE USING r* 18 IN THE STUDIES THAT WERE RELEASED IN JANUARY 19 OF 1974? 20 A. WELL, THE -- 8Y THEN, HE W*S * 21 WORKING WITH CONCENTRATIONS OF ASOUT S3 22 P.P.M.. WHEN -- 50 3.P.M. BALL PARX. TO THE 23 3EST OF MY KNOWLEDGE, WHEN 3.F. GOODRICH MADE 24 THE ANNOUNCEMENTS IN JANUARY, 1974, l DON'T 25 THINK THEY DISCLOSED DETAILS OF THE MATALONI ASI-PR 0004370 oss - DR. EPSTEIN - MR. RENNEISSN 12? TESTS. THE INFORMATION ON THE "ATALONI TEST CAME FROM THE SUBSEQUENT PUBLICATIONS NOT NEW YORK ACCAOEMY OF SCIENCE VOLUME ANO OTHER PLACES. BUT IT WAS ABOUT 50 P.P.M. BY 1 o 7 tf. Q. THEN LATER, HE CONTINUED STUDIES. IS THAT RIGHT? A.- THAT'S CORRECT, YES. A SET OF ONGOING STUDIES. Q. AND THEY, ARE THEY STILL ONGOING? A. TO THE BEST OF MT <NQWLEDGE, THE OVERWHELMING MAJORITY OF THEM ARE COMPLETE AND HAD BEEN COMPLETED BY 1979. THEY WERE INFLUENCED -- THEY WERE PRESENTED IN COLD SPRING HARBOR SYMPOSIUM IN 197?. 0. I THINK YO'J MENTIONED THAT I >4 ANIMAL STUOIES, A SINGLE DOSE OF VINYL CHLORIDE DID PRODUCE TUMORS OR DO I RECALL YOUR TESTIMONY INCORRECTLY? A. YOU RECALLED IT CORRECTLY BUT YOU'RE LINKING IT NOW WITH MATALONI WHICH IS NOT WHAT HE STUDIED. Q. WHO DID THAT? A. THAT WAS A CONSUMER PRODUCT SAFETY COMMISSION ON STUDY ON BRIEF EXPOSURES TQ VINYL CHLORIDE. ASI-pR 0004371 - OR. cFSTclN - MR. RENNEISSM 133 1 Q. . H A T W A 3 THE OOSAGE FOR THAT 3RIEF 2 KNOWLEDGE? 3" A. WELL IT WAS A RANGE OF YOUR OOSAGE 4 GOING FROM 50 P.P.M. TO ABOUT, I THINK, 5,000 5 OR SO ANO THE RANGE AT -- AT THE ONE HOUR 6 LEVEL, THE LEVEL -- THE LEVEL AT WHAT THEY 7 AT WHICH THEY GOT TUMORS AT ONE HOUR WAS 3 50 -- WAS 500 P.P.M.. SO, FOR THE ONE HOUR 9 EXPOSURE, THAT -- WHICH WASN*T A MATALONI 10 STUDY, WHICH WAS IT IS CONSUMER PRODUCT t 11 SAFETY COMMISSION, THEY GOT EFFECTS AT 12 AT 500 P.P.M.. THE MATALONI STUDY, WHICH I 13 WAS REFERRED TO OF THE LOWEST LEVEL, THE ONE 14 P.P.M., THAT WAS AN INTERMITTENT EXPOSURE 15 OVER THE COURSE OF A YEAR, AT WHICH THE 16 3REAST CANCER WERE DEVELOPED FOLLOWING. 17 Q. WHEN YOU SAY INTERMITTENT, EIGHT 18 HOURS ON, EIGHT 19 A. NO, BASICALLY IT WAS A BQUR HOUR. 20 FOR THE ONE PART PER MILLION STUDY, IT WAS - 21 TO THE SEST OF MY RECOLLECTION, IT WAS 22 FOUR HOURS -A DAY FOR FIVE DAYS- A WEEK ON AND 23 OFF FOR THE YEAR. THAT WAS -- THAT WAS AN 24 intermittent level. 25 Q. FOUR HOURS A DAY 'ASI-p 004372 cr 5 - DR. P5T IN - .MR. RENNEISEN 151 1 A. 2 Q. FIVE DAYS A WEEK. FIVE DAYS A WEEK. 3 A. 4 Q. YEAH. IS THERE A WAY TO RELATING DOSE IN 5 RATS AND DOSAGE IN MAN, TAKING INTO 6 CONSIDERATION THEIR RESPECTIVE WEIGHTS OR 7 ISN'T THAT NECESSARY? 3 A. WELL, YOd KNOW, I CAN'T REALLT TELL 9 YOU WHETHER IT'S NECESSARY. IT'S POSSIBLE TO 10 DEVELOP A LOT OF PAPER CALCULATIONS ON THIS 11 RESPECT. AND RELATING DOSE ON THE BASIS OF 12 SURFACE AREA OR WEIGHT. THIS COULD 3E DONE. I 13 DON'T HAVE -- I HAVEN'T MADE THESE 14 CALCULATIONS . 15 GENERALLY, I THINK IN 16 CARCINOGENESIS EXPERIMENT, ONE USES ANIMAL 17 DATA, NOT FOR MAKING QUANTITATIVE INFEDENCS, 18 3UT SIMPLY FOR SAYING WHETHER THE MATERIAL tS 19 CARCINOGENIC FOR NOT OR NOT. THAT'S WHY I 20 HESITATED A 3IT A30UT 21 3. YOU .HADE REFERENCE TO, I THINK, 22 TESTS CONDUCTED 3Y THE CONSUMER PRODUCT 23 SAFETY COMMISSION, THAT PRODUCED 3 REAS T 24 TUMORS, IS THAT RIGHT? 25 A. NO. I'M AFRAID -- I APPEAR TO EE ASI-PR 0004373 D 3. EPSTEIN - MR. PENNS ISSN 111 1 CONFUSING YOU. 2 the mataloni study at one 3 PART PER MILLION PRODUCED aREAST TUMORS, 4 g. WHAT DIO THE C.P.S. -- THE 5 CONSUMER SAFETY PRODUCTS 6 A. FINE. THE CONSUMER PRODUCT 7 COMMISSION PRODUCED PULMONARY ADENOMAS AND 8 THESE ARE SO CALLED 3ENIGN TUMORS OF THE LUNG 9 AND PULMONARY ADENOCARCINOMAS. 10 0. AND THE ANGIOSARCOMA 11 A. NO, NO. NO, THOSE WERE PULMONARY 12 TUMORS. 13 Q. DOCTOR, YOU HAVE REFERRED TO A 14 SERIES OF ARTICLES AND I THINK I HAVE COPIES 15 OF MOST OF THEM HERE. 16 IF I REFER TO AN ARTICLE THAT 17 YOU DON'T HAVE, I THINK I HAVE AN EXTRA COPY, 18 3JT IF YOU CAN LOCATE TOURS, THAT WOULD 3E 19 FINE. 20 3UT 3EF0RE WE GET TO ARTICLES, 21 I HAVE A COUPLE OTHER QUESTIONS I'D LIKE TO 22 ASK YOU. 23 I 3 EL I EVE YOU ALREADY HAVE 24 TESTIFIED THAT ARSENIC IS A KNOWN C-i'JSE OF 25 ANGIOSARCOMA; IS THAT CORRECT? ASI-PR 0004374 iS - D* EPSTEIN MR. R E N N E { SEN 133 1 A. YES, 51*. 2 Q. AND YOU KNOW THAT FROM LITERATURE 3 STUDIES THAT YOU HAVE READ; IS T*AT CORRECT? 4 A. YES, SIR. 5 0. DO YOU KNOW THAT HR. GRAS50 LIVED IN 6 SALEH COUNTY, NEW JERSEY AND that SALEM 7 COUNTY IS RURAL AND, FURTHERMORE, THAT 8 ARSENIC VMS USED AS AN INSECTICIDES IN SALEM 9 COUNTY. DO YOU KNOW THAT? 10 A. I DIDN'T KNOW THAT, 3UT I WOULDN'T 11 3 E SURPRISED. 12 q. I TA.<E IT YOU KNOW THAT ARSENIC IS 13 ANINGREDIENT IN INSECTICIDES? 14 A. I DO. 15 Q. ARSENIC IS A MINERAL, ISIT NOT? 16 A. WELL, I ANYONE PERHAPS MORE 17 CORRECTLY CALL IT A METALLOID, RUT I CALL IT 18 A MINERAL RY ALL MEANS. 19 0. WELL, I DON'T WANT TO RE 20 UNSCIENTIFIC. WHAT IS THE DIFFERENCE BETWEEN 21 A MINERAL AND A METALLOID? 22 A. I THINK THATTECHNICALLYTHE TERM IS 23 THE METALLOID, BUT I'D RATHER NOT GET INTO 24 25 0. IN ANY EVENT, AFTER YOU SPRAY IT ON ASI-PR 0004375 3 J \ m 3 ;i* 'i 1i j - 1 r.-te GROUNDS, IT DOESN'T DISSOLVE INTO 2 SOMETHING ELSE, DOES IT? 3 m. W ELL, THE META30LIC NATURE OP 4 ARSENIC IS- -- SOME OF IT IS INTERESTING. 5 SO.ic OF IT CAN BECOME INCORPORATED, SOME OF 6 IT CAN 3ECOME METALLATED, SOME OF IT CAN 7 BECOME SOLUA3LE AND LEACH INTO WATERS. SO, 8 IT'S -- AND SOME OF IT, ON THE OTHER HAND, 9 CAN ALSO BECOME AERSOLIZED ANO BLOW UP INTO 10 DUST WHICH CAN BECOME WIDELY DISSEMINATED IN 11 A COMMUNITY. 12 0. DIO YOU CONSIDER ARSENIC AS A 13 POSSIBLE CAUSE FOR MR. GRASSO'S ANGIOSARCOMA? 14 A. I CONSIDERED EVERY POSSIBLE CAUSE, 15 NAMELY OF THE FOUR WHICH WE HAVE CONSIDERED. 16 THERE WAS ONLY 0jE FOR WHICH THERE APPEARED 17 TO 3E SUBSTANTIAL DOCUMENTATION ANO THAT IS 18 THE BASIS FOR MY VIEWPOINTS OF SUBSTANTIAL 19 PROBABILITY -- OR PART OF THE BASES FOR THE 20 VIEW POINT OF SUBSTANTIAL PROBABILITY. 21 0. IN RULING OUT ARSENIC, DID YOU MAKE 22 ANY INQUIRY AS TO THE ARSENIC LEVEL OR 23 EXPOSURE 0= ARSENIC IN SALE** COUNTY? 24 A. SIR, I DID NOT RULE OUT ARSENIC. M Y 25 ANSWER TO T-E OUESTION WAS -- I WAS -TALKING ASI-PR 0004376 CR DR. EPSTEIN 4 3 R c .m N E l 5 E N 135 1 about substantial probability, i *m not 2 PREPARED TO EXCLUDE ARSENIC. I JUST DO* ' T 3 HAVE THE INFORMATION ON THE BASIS OF WHICH I 4 COULO INCLUOE THAT IN A STATEMENT ON 5 CAUSATION. THE ONLY INFORMATION I HAVE OF THE 6 POUR AGENTS WHICH ARE KNOWN TO INDUCE 7 ANGIOSARCOMA IS THAT HE WAS EXPOSED TO WHAT 8 APPEARS TO BE SUSTAINED AND INTERMITTENT AND 9 EPISODIC VERSUS OF VINYL CHLORIDE OVER A 10 PERIOD OF FIVE TO SIX YEARS. I DON'T HAVE 11 THIS INFORMATION FOR ANABOLIC STEROIDS OR 12 THORIUM OR FOR ARSENIC. 3UT I'M NOT EXCLUDING 13 THESE POSSI3ILIT1ES. 14 Q. DOCTOR, I BELIEVE YOU'VE TOLD US 15 THAT THERE IS NO SAFE LEVEL FOR EXPOSURE TO 16 VINYL CHLORIDE; IS THAT CORRECT? 17 A. 18 MO, SIR. THAT'S NOT WHAT I SAID. I SAID WE DON'T KNOW O* 19 ANYWAY OF SETTING SAFE LEVELS OF EXPOSURE TO 20 ANY CARCINOGEN, INCLUDING VINYL CHLORIDE. 21 THAT ISN'T THE SAME AS SAYING THERE IS NO 22 SAFE LEVEL. - 23 <J. WOULD YOUR STATEMENT BE THE SAME FOR 24 ARSENIC AS FOR 25 A. OH, CERTAINLY, FOR ANY CARCINOGEN WE / ASI-PR 0004377 f 0*1 5 S 5PST5 lN A 3 3 E NNE I S EM i5s 1 DON'T <\0W of ANY'-.'ay Oc S = TTI\fi 5A = E LEV-LS. 2 Q. IS THERE A SAFE.LEVEL? 3 A. I'VE JUST T 0 L 0 YOU, WE DON'T <NOW Or 4 ANY WAY OF SETTING SAFE "LEVELS . IT 15 THE 5 soncenSus of the informed independent 6 SCIENTIFIC COMHUN I T I ES THAT WE <NOW OF NO WAY 7 Or- SETTING SAFE LEVELS OF EXPOSURE TO AMY 8 CHEMICAL CARCINOGEN. THE HIGHER THE LEVEL OF 9 THE EXPOSURE^ THE HIGHER THE RISK. THE LOWER 10 THE LEVEL OF THE EXPOSURE, THE LOWER THE RtS<. 11 3 U T WE DON'T <NOW OF ANY WAY OF SETTING SAFE 12 LEVELS. 13 Q. AND I 3 EL I EVE YOU HAVE S A 10 A SINGLE 14 EXPOSURE COULD RE ENOUGH? 15 A. I SAID THAT ON THE S4SIS OF THE 16 CONSUMER PRODUCT SAFETY COMMISSION STUDY, IT 17 APPEARS THAT AN EXPOSURE AS 3RIEF AS ONE HOUR 18 TO VINYL CHLORIDE IS ENOUGH TO PRODUCE 19 CHEMICAL -- TO PRODUCE CARCINOGENIC EFFECTS. 20 WE XNOW FROM A WIDE RANGE OF STUDIES IN 21 CHEMICAL CARCINOGENESIS THAT SINGLE 22 ADMINISTRATION OF MANY DIFFERENT CARCINOGENS 23 IS ENOUGH TO PRODUCE CANCER. 24 0. THEN A SINGLE EXPOSURE TO A 25 CARCINOGENIC INSECTICIDE CAN RE PLOUGH, TOO? ASI-PR 0004378 L ^ U SS - ->* HST; I N MR. re I 5 En 13 7 1 1 1 M :N 0 T MILLING to EXCLUDE THAT. 3 U T 2 m rl E N IT COMES TO VINYL CHLORIDE, W E 30 HAVE A 3 STRIKING ST JOY, SET UP BY THE COMMISSION, 4 SIMPLY TO LOOK AT THE HAZARDS LIKE FIREMEN 5 AND POLICE, AT A TANK CAR INVOLVEMENT, THE 6 QUESTION IS ARE THESE PEOPLE AT RISK. AMO 7 THEY CONCLUDED THAT EVEN FRO^ * SINGLE R3IE= 8 EXPOSURE TO VINYL CHLORIDE, THERE ARE 9 DEMONSTRABLE RISKS. 10 q. I THINK IN YOUR DIRECT EXAMINATION, 11 YOU ANSWERED QUESTIONS ABOUT LATENCY AND l 12 BELIEVE YOU DEFINED 13 THE COURT: WOULD YOU LIKE 14 SOME MORE WATER. 15 THE WITNESS: YES, SIR, I 16 WOULD APPRECIATE THAT. 17 BY MR. RENNEISEN: 18 0. I WAS TALKING ABOUT LATENCY, DOCTOR, 19 AND I THINK YOU DEFINED LATENCY AS THE oERIOO 20 OF TIME FROM THE FIRST EXPOSURE TO DIAGNOSIS. 21 A. YES. YOU RECALL, WHEN I WAS 22 ANSWERING THIS, I INDICATED THERE ARE SEVERAL 23 WATS OF DEFINING LATENCY AND I THINK ON THE 24 WHOLE, THE BEST ONE IS =R0M THE TIME OF FIRST 25 EXPOSURE TG THE DATE OF DIAGNOSIS OR DEATH. ASI-PR 0004379 S - OR. EPSTEIN - MR. REWNEISEW M* 1 THE IE A IE OTHER WAYS OF DEFINING IT, SUT l 2 T HIN < IN THIS CONTEXT, THAT'S THE MCST 3 appropriate ONE. 4 0. I JUST WANTED to MAKE.SURE WE WERE 5 30TH USING THE WORD THE SAME WAY. 6 A. YEAH. 7 Qr AND THE TERM EXPOSURE TIME I THINK 8 MEANS THE TIME THE PERSON WAS EXPOSED; ISN'T 9 THAT. TRUE? 10 A. YES. OF COURSE, ONE CAN 3E MORE 11 PRECISE A30UT THIS WHEN IT COMES TO A WORKER 12 WHO HAS GONE INTO A PLANT AND WORKED WITH 13 VINYL CHLORIDE, YOU CAN ACTUALLY PUT A DAY ON 14 IT. WHEN IT COMES TO RESIDENTIAL EXPOSURE, 15 FOR WHICH WE HAVE TO NOW -- 3ECAUSE THERE 16 WASN'T ANY MONITORING DONE AT THE TIME 17 BECAUSE WE DIDN'T KNOW EXACTLY HOW MUCH VINYL 18 CHLORIDE WAS BEING PUT OUT IN THE STACK AND 19 THE PERIMETER OF THE PLANT WASN'T 8EING 20 MONITORED AND THE COMMUNITY WASN'T MONITORED, 21 WE CAN'T PUT AN EXACT DATE WHEN EXPOSURE 22 COMMENCED. WE CAN SAY IN ALL PROSA3 ILITY, MR. 23 GRASSO'S EXPOSURE COMMENCED IN 1970 WHEN THE 24 PEDRICKTOWN -- PEDRICKTOWN PLANT STATED 25 OPERATION, 9UT WE DON'T KNOW AN E XACT DATE. ASI-PR 0004380 "3 % 5 - 0R . ?ST IN - ^ . o m I 55M 13 1 Trtx 13, I .jOULD SAY, A LlUlc `.ORE 2 uncertainty WHEN it comes to j. E 3 I > c n t I a L. T -t A \ 3 WHEN IT COMES TO OCCUPATIONAL. 4 Q. WITH RESPECT TO THE 3.F. GOODRICH 5 PLANT, WE KNOW THAT OPERATION BEGAN ON MARCH 6 25, 1970. SO, THAT ANY EXPOSURE MR. GRA5SO 7 HAD TO VINYL CHLORIDE 9EcORE THAT TIME CAME 8 FROM SOMEPLACE ELSE. 9 A. YES, RUT I'M SAYING WE-DOM'T <*40W 10 THE SPECIFICS OF THE EXACT TIME AND DATE AT 11 WHICH INDIVIDUAL EXPOSURES IN 17(1 COMMENCED. 12 Q. THAT'S TRUE. 3UT WE KNOW ITCAN'T BE 13 3EFORE THE PLANT 3 EGAN 14 A. PRECISELY. 15 Q. 16 A. -- TO OPERATE? PRECISELY. 17 Q. DOCTOR, l HAVE HERE BOTH COPIES OF 18 YOUR BOOK, THE FIRST EDITION AMD THE SECOND 19 EDITION. 20 DO YOU HAVE EITHER IBOOK WITH 21 YOU? 22 A. r HAVE THE SECOND ONE, NOT THE FIRST. 23 0. LET US TRY THEN TO USE THE SECOND 24 ONE BECAUSE THE PAGE NUMBERS ARE A LITTLE 25 DIFFcRENT. ASI-PR 0004381 Cq SS - JR . EPSTEIN MR. RENNEI5EN 14 3 1 A. 2 0. SURE. LAST NIGHT I HA 0 TO BUY THE SECOND 3 ONE SO THAT I COULO COORDINATE THE 3 A S E 4 NUMBERS. 5 ON PAGE 111, YOU STATED, * * 6 "WHILE THE OCCUPATIONAL EXPOSURE PRECEDING 7 THE CANCER HAVE USUALLY RANGED PROM 13 TO 20 8 TEARS, THERE HAVE 3EEN FOUR REPORTED CASES OF 9 ANGIOSARCOMA FOLLOWING LESS THAN SIX YEARS OF 10 HUMAN EXPOSURE." AND I BELIEVE TODAY, IS THAT 11 INFORMATION STILL CORRECT OR ARE THERE MORE 12 OR LESS THAN FOUR NOW? 13 . A. WELL, WHEN l WAS TALKING TODAY, I 14 CLASSIFIED THEM AS TEN YEARS -- AS UNDE?. 15 TEN YEARS. ANO I CITED TWO, ONLY TWO TODAY, 16 'WHICH -- FOR WHICH I WAS CONVINCED ON A 17 RECENT REVIEW OF THE LITER 4 TUR E THAT THE 18 ANGIOSARCOMAS HAO OCCURRED WITHIN SIX YEARS. 19 SO -- 20 Q. SO, IT'S TWO INSTEAD FOUR? 21 A. WELL, NO, FOR SIX YEARS, THAT'S 22 CORRECT, YES. 23 Q AND THEN YOU WENT ON TM YOUR 3Q0< 24 AND SAID, THE TRUE INSURANCE DENSE Or VINYL 25 CHLORIDE CANCER IN EXPOSED WORKERS TS STILL ASI-PR 0004382 3 DR. EBSTEIN P 1M j 3 C A 'J S E OF LONG LATENCY PERIODS; IS THAT CORRECT? A. THAT'S CORRECT. Q. AND I RELIEVE YOU.ALREADY TOLD US THAT THE AVERAGE -- WELL, LET HE AS< YOU AGAIN: WHAT IS THE AVERAGE LATENCY PERIOD, AS YOU UNDERSTAND IT? A. WELL, THERE HAVE SEEN VARIOUS ESTIMATES OF THIS, AS I INDICATED BEFORE, BUT I CITED REFERENCE TO HEATH EASED ON C.D.C. DATA OF ABOUT 20 POINT THREE Y E A3 S WHICH SEEMS TO 5 E IN THE* <IN0 OF A BALLPARK. Q. DOCTOR, I WISH YOU'D ONLY HAD ONE PU3L-ICATION OF THIS BOOK. NOT REALLY; I'M GLAD YOU.MANAGE TO SELL IT TWICE. IN THE FIRST BOOK, FOOTNOTE IS IS FOOTNOTE 19 IN THE SECOND 300K. I CAN'T FIND FOOTNOTE 19. BEAR WITH ME A SECOND, DOCTOR. A. I'LL TURN TO AGS 597, THAT'S FOOTNOTE REFERENCE -- PLACE 0. WHAT PAGE? A. PAGE 597 WILL GIVE YOU WAXWeILLER ET A L., 19. Q. HOW, THE WAXWEILLER ARTICLE WHIC-* ASI-PR 0004383 DR. c i5 5 T t I tt R . 3 c N N E I S E.; * 1*4 2 YOU HAVE TO, DO YOU HAVE A COPY OF THAT? A. YEAH, I THINK SO. A. SURE . Q- NOW, IN THE WAXWEILLER ARTICLE ON PAGE 45, THERE IS A TA3LE SHOW ING EXPOSURE YEARS AND LATENCY PERIODS FOR ANGIOSARCOMA; IS THAT CORRECT? A. YEAH . Q. AND THAT TABLE SUMMARIZES 11 CASES OF ANGIOSARCOMA AND I GUESS IT GIVES THE TOTAL EXPOSURE IN YEARS AND LATENCY PERIODS; IS THAT CORRECT? A. THAT'S RIGHT. Q. DID YOU RELY ON THAT INFORMATION IN PREPARING YOUR -- THE CHAPTER OF TOUR 30C< dealing WITH VINYL CHLORIDE. A. amongst many other. Q- THAT ARTICLE DOESN'T SAY ANYTHING A3QUT SHORT LATENCY PERIOD, DOES IT. A. THAT'S RIGHT. M fT DOES HAVE WOULD THAN SHORT EXPOSURE PERIOD, DOESN'T IT, IN THAT TA3LE ON PAGE 45? A. SURE, 3 U T THAT'S NOT LATENCY. ASI-PR 0004384 C V 55 - 33 EPS" f V - MR. RENNSISS- : '4 1 C. 30 THIS'S ONE GENTLEMAN W MO 'PAS * 2 THS:E Y A R cX = 05'J. 3 E R I 0 0 i'!D A 17 YEAR 3 latency period. 4 A. YEAH, ABSOLUTELY. 5 Q. AND DO YOU KNOW FROM OTHER SOURCES 6 THAT THAT .GENTLEMEN WAS A REACTOR CLEANER AT 7 THE 3.F. GOODRICH PLANT? 8 A. I DON'T HAPPEN TO KNOW THAT, NO. 9 0. DOCTOR, IS IT TRUE THATVInYL 10 CHLORIDE WAS USED AS A OR0PELL4NT IN AEROSOL 11 SPRAY CANS OF HAIR SPRAY, DISINFECTANTS, 12 FURNITURE POLISH AND SO FORTH? 13 A. AMD PESTICIDES, SURE. 14 Q. AND DID YOU REPORT in YOUR 3C0< THAT 15 E.P.A. STUDIES SHOW THAT DURING THE USE QF 16 HAIR SPRAY OR INSECT SPRAY, USERS BREATHE 17 V IN X.L CHLORIDE IN THE RANGE OF 100 TO 40 0 18 PARTS PER MILLION? 19 A. RIGHT. 20 Q . AND, ALSO, DID YOU' REPORT IN YO'JR 21 BOOK THAT IN 1974, IT WAS FOUND THAT VINYL 22 CHLORIDE LE-VELS AS HIGH AS NINE PARTS PER 23 MILLION COULD RE FOUND IN VEGETABLE OIL SOLD 24 IN 50LID -- SOLD IN LIO'JtD 25 POLYVINYLCHLORIDE CONTAINERS? ASI-PR 0004385 c rqss DR EP S TE IN 'l 1 . StN'15 I 5 i;,J 14 L 1 m. RI jHT. 2 Q. THEN IT'S TRUE THAT MR. S R A S S G 01 3 ANY OF US COULD 3E EXPOSED TO VINYL CHLORIDE 4 FROM A VARIETY SOURCES; IS THAT TRUE? 5 A. AT THE PRESENT MOMENT, I WOULD SAY 6 THE MAJOR POSSIBLE SOURCE IS RESIDENTIAL 7 3 5-CAUSE THE SPRAY CANS HAVE R E EN TAKEN OFF 8 THE MARKET AND THE RIGID CONTAINERS, 3 IG10 9 PVC CONTAINERS ARE NO LONGER USED FOR FOOD 10 PRODUCTS. AND LEVEL Or VC, ALSO, ARE VERY 11 MUCH REDUCED AT THEM. I WOULD SAY AT THE 12 PRESENT MOMENT RESIDENTIAL IS PR03A3LY THE 13 MAJOR SOURCE OF NONE OCCUPATIONAL E.XPOSURE. 14 Q. 3 UT 3ACK IN THE LATENCY SIXTIES, 15 THERE WERE OTHER 16 A. I COULDN'T AGREE MORE AND CAN'T 17 EXCLUDE THESE POSSIBILITIES. 18 Q. DOCTOR, IN YOUR BOOK, I'LL READ IT 19 TO YOU, IF YO'J NEED THE PAGE NUMBER*. IT'S 20 PAGE TWO OF THE FIRST EDITION AND IT'S IN THE 21 PREFACE OF THE LATER EDITION. "THE 22 OSVELOPrtENT- OF CANCER IS -- IS, OF COURSE, 23 PROFOUNDLY INFLUENCED 3Y GENETIC, ENDOCRINE, 24 immunological, virile, biochemical and 25 P05SI3LY EVEN PSYCHOLOGICAL FACTORS." IS THAT ASI-PR 0004386 C R Q ss DP . EPS TE I N MR. ''ENNEISEN L'+5 1 STILL you* OPINION, DOCTOR? 2 A. SURE, THAT'S THE EASTS 0 * W-AT V/S 3 CALL THE MU L TIF AC TOR IAL ETIOLOGY OF CANCER. 4 IN OTHER WORDS, A .VERY WIDE RANGE OF AGENTS 5 CAN INFLUENCE THE DEVELOPMENT OF CANCER 6 FOLLOWING EXPOSURE, EVEN TO A SPECIFIC CANCER 7 CAUSING AGENT. CERTAINLY THIS IS, I THINK, 8 THE COMMONLY ACCEPTED VIEWPOINTS. 9 Q. DOCTOR, YOU HAVE SAID -- AND I 'LL 10 ASK IF YOU STILL AGREE -- THAT THERE ARE 11 MANY INDUSTRIAL CHEM ICAL CARCI NOGENS NOT YET 12 IDENTIFIED? 13 A. SURE. 14 0.' ISN'T IT TRUE -- OR DO YOU KNOW 15 LET ME ASK YOU -- YOU DO KNOW THAT MR. 16 GRASSO WORKED .AT THE DUPONT PLANT. 17 A. 18 Q. SURE . YESTERDAYAN EMPLOYEE FROM THE PLANT 19 TESTIFIED THAT OVER 3,000 CHEMICALS WERE USED 20 THERE. DID YOU KNOW THAT? 21 A. 22 Q. YES. I-NC IDENTALLY, DO YOUKNOW WHEN THE 23 SPRAY CANS OF VINYL CHLORIDE WERE REMOVED 24 FROM THE MARKET? WAS IT 1 R7U, 75 OR WAS IT 25 SOME TIME EARLIER? ASI~pr 0004387 CRD ss - OR EPSTEI 'H - r E u;; E t s E n 14 > 1 I'D HAVE TO CHECK THE BOOK. I 2 BELIEVE IT WAS A30UT 75. I 0 F F H A N 0 DON'T 3 RECAlL EXACTLY, BUT I THINK IT WAS ABOUT 75. 4 LET HE JUST CHECK. 5 THE ANSWER IS THE CONSUME!? ' 6 PRODUCT SAFETY COMM ISSION, ON PAGE III? SAYS 7 NO NEW CONSUME? PRODUCTS CONTAINING VC WERE 3 MANUFACTURED SINCE 74, 3 UT ON T"E QTHE3 "AND 9 THE ARTICLE -- THE BOOK ALSO POINTS OUT 10 THAT THERE WASN'T A RECALL OF THESE PRODUCTS 11 SO, IT'S POSSIBLE THAT SOME OF THEM REMAINED 12 ON THE MARKET UNTIL 73. 13 Q. THE RATS THAT DOCTOR VIOLA -- IS 14 HE AN M.O. CR -- IF YOU KNOW? 15 A. I THINK HE IS, 8UT I'M NOT 16 ABSOLUTELY SURE. 17 Q. WELL, WE'LL CALL HIM OOCTOR VIOLA? 18 A. WELL, HE WAS EITHER; HE WAS A PH.D 19 OR M.D., WHATEVER. 20 Q. WHEN DOCTOR VIOLA EXPOSED RATS IN 21 1970, HE WAS USING DOSES OF 3,000 P4RT3 22 30,000 PARTS PER MILLION, WAS HE NOT? 23 A. AMONG OTHER DOSES. MUCH WAS ALSO 24 USING MUCH LOWER DOSES. RUT HE DIDN'T REPORT 25 ON THE lOwER DOSES IN 1970. ME ONLY REPORTED ASI-PR 0004388 CROSS DR . EPSTEIN .-13. RENNEISEN 1 '*7 1 ON THE HIGHS* DOSES IN 1^70. HE REPORTED ON 2 THE LOWE" DOSES AT A S UB 5 E C'JE N'T * E E T J \ Q with 3 THE MANUFACTURING CHEMISTS' A 5SDCIAtI ON. 4 Q. THIS- IS VIOLA 0* MATALONI? 5 A. VIOLA. 6 Q. WITH RESPECT TO THE 30,000 PARTS PER 7 MtLLION -- THAT'S THREE PERCENT AND THAT'S 8 THE EXPLOSIVE LIMIT, IS IT NOT? 9 A. SOMEWHERE ROUND A30UT. IT'S A PRETTY 10 HIGH CONCENTRATION. 11 Q. DO YOU KNOW WHY HE WAS CONDUCTING 12 THOSE STUDIES? WHAT WAS HE LOOKING POR? WAS 13 HE LOOKING *09 CANCER OR WAS HE LOOKING cOR 14 AN EXPLANATION OF THE ACROOSTcOLYSIS? 15 A. YOU'VE A 5 .< E 3 THE QUESTION AND I'VE 16 ANSWERED IT. IT'S BASICALLY AT 17 ACRE00STE0LY5IS THAT HE WAS LOOKING *QR AND 18 HE .-- AND HE FOUND THESE IN THE COURSE 0* 19 EXPERIMENT. 20 0* I 3SLIEVE YOU HAVE TOLD US THAT HE 21 WAS DOING THE STUOIES EITHER AT THE DIRECTION 22 OF OR AS AN EMPLOYEE OF A CHEMICAL COMPANY IN 23 ITALY; IS THAT 24 A. TO THE S EST OF MY KNOWLEDGE, HE WAS 25 THEN WORKING FOR SALVATE INDUSTRIES. ASI-PR 0004389 ca 3 DR. P 3 T 1V M3 REN\E ISE\ l Q. 13 THAT A CHEMICAL COMPANY? 2 A. I REALLY DON'T <NO W MUCH A30UT 3 5JLVATE INDUSTRIES, 3UT 4 Q. 3EFORE THAT, WAS ANY RESEARCH DONE 5 IN MEDICAL SCHOOLS OR BY THE MEDICAL 6 PROFESSION WITH RESPECT TO VINYL CHLORIDE IN 7 RATS THAT YOU KNOW ABOUT? 8 A. WELL, I WENT THROUGH A BRIEF 9 CHRONOLOGY OF THE -- OF THE STUDIES THAT 10 WERE OONE. IT WOULDN'T -- WHEN I LEe T OUT 11 IN THIS COUNTRY, WHICH WAS UNINTENTIONAL, 12 WERE SOME STUDIES ABOUT DOW, AMONG OTHERS, 13 OORKEL5CN, BUT THERE WERE VERY FEW STUDIES IN 14 THIS COUNTRY ON CHRONIC TOXIC EFFECTS OP 15 VINYL CHLORIDE. AND THE EXTRAORDINARY THING 16 ABOUT IT, IS THAT THERE WERE NO 17 CARCINOGENICITY SUBSTITUTED DIFFICULTIES, 18 EVEN-THOUGH A WIDE RANGE OF WORKERS HAD BEEN 19 HANDLING MATERIAL, AND EVEN ALTHOUGH WE KNEW 20 FROM THE LITERATURE, IT MAO TOXIC EPFECTS 21 EVEN AT LEVELS AS LOW AT 50 P.P.M.. SO, IT IS SURPRISING.' Q. BUT IT WASN'T JUST INDUSTRY THAT WASN'T DOING ANY STUDIES, NO ONE DIO ANY STUDIES, ISN'T THAT TRUE? ASI-PR 0004390 ss OR. EPSTEIN A R. R E N N E l S E N 14? A. WELL, THE ONLY TYPE OF INDIVIDUAL OR INSTITUTION THAT WOULD HAVE AN INCENTIVE TO WORK AND TO TEST A PRODUCT IS THAT -- IS THE INDUSTRY THAT MANUFACTURES THE ROOJCT AND EXPOSES ITS WORKERS TO IT. Q. WELL, AT THE PRESENT TIME, YOU'RE INVOLVED WITH CONSIDERING CHEMICAL CARCINOGENS, ARE YOU NOT? A. INDEED. Q. AND YOU ARE NOT PART Or THE CHEMICAL INDUSTRY IN ANY WAY, ARE YOU? A. I DON'T THINK SO. Q. NOT? YET, YOU HAVE AN INTEREST, DO YOU A. YES. 3 U T TO UNDERTAKEt^sts AS EXPENSIVE AND -- IT'S ONLY VERY RECENTLY THAT THE GOVERNMENT HAS STARTED PAYING FOR TESTS FOR CARCINOGENICITY ON PROFITABLE PRODUCTS. IT HAS SEEN A POSITION OF THE GOVERNMENT THAT INDUSTRY HAS A RESPONS I 3 I LITY FOR PRETESTING ITS PRODUCTS PR I OR TO INTRODUCTION IT TO THE PU3LIC. q. WAS ANYONE ELSE OTHER THAN INDUSTRY DOING STUDIES? AND I THINK YOU SAID NO. A. I DON'T KNOW OF ANY STUDIES ON VINYL ASI-PR 0004391 C ? ss - or. epste in I SEN l sn 1 CHLORIDE DONE OF THE CHRONIC TOXICITY NATURE 2 DONE OTHER THAN 3Y INDUSTRY, WHICHEVER C\ 3 EXCEPTION. THAT IS, SOME OF THE EARLIER 4 STUDIES, THE PATTI STUDIES AROUND THE 5 THIRTIES OR FORTIES WIJM THE VERY ACUTE HIGH 6 ANIMALS GOT ARYTHMIA ANO WENT TO SLEEP, 7 SOME OF THOSE TESTS WERE DONE 9Y THE UNITED 8 STATES GOVERNMENT. PATTI, I RELIEVE, DID *AVE 9 SOME MONEY FROM THE UNITED STATES GOVERNMENT. 10 I'M NOT CERTAIN A30UT THAT, RUT I THINK SO. 11 0. DOCTOR, I 3ELIEVE YOU'VE INDICATED 12 IN YOUR 8 OOK THAT UP TO 19 7'4, THE PSRMI5S IDLE 13 EXPOSURE LEVEL FOR U.S. WORKERS WAS 530 PARTS 14 PER MILLION; IS THAT CORRECT? 15 A. YES. 16 Q. AND I THINK YOU'VE ALSO STATED IN 17 YOUR 300K THAT IN APRIL OF 197<4, OSHA 18 E S TA3LI SHED A NEW EMERGENCY STANDARD OF 50 19 PARTS PER 3ILLION; IS THAT CORRECT? 20 A. CORRECT. 21 0. ANO THEM SOMETIME AFTER THAT, T;hp 22 WORKPLACE STANDARD WAS LOWER T0 ONE PART PER 23 3ILLI0N; IS THAT CORRECT? 24 A. YES. THERE WERESOMESTATEMENTS IN 25 3ETWEEN, 3JT, YES. ASI-PR 0004392 c r; S - OR. EPSTEIN - HR. RE.VNEI5EN 151 l Q. NOW, DURING THE COURSE OF THIS TRIAL, 2 WE'VE SEEN T A L <IN G A 3 0 U T PARTS DE R BILLION 3 AND AT LEAST ON ONE OCCASION YESTERDAY, 4 PROFESSOR P E S K I N REFERRED TO PARTS ER 5 BILLION. 6 AM I CORRECT IN UNOERSTAMDING 7 THAT THERE ARE 1,000 -- THAT IN ORDER TO 8 TURN -- LET ME ASK IT THIS WAY -- 1,000 9 PARTS. PER 3 I LLI ON EQUALS ONE PART PER MILLION? 10 A. SURE. 11 Q. NOW, IN CONNECTION WITH THIS LAWSUIT, 12 YOU WROTE A REPORT, DID YOU NOT, TO HR. 13 VASSALOTT I ? 14 A. I WOULDN'T DIGNIFY IT BY THE NAME OF 15 A REPORT. THESE WERE SOME VERY, VERT, 16 PRELIMINARY KIND OF THOUGHTS IN AUGUST OP 17 LAST YEAR, WHICH WAS VERY PRELIMINARY INDEED. 18 Q. WELL, WHETHER YOU WOULD DIGNIFY IT 19 WITH THE NAME REPORT OR NOT, DM THE COVER, IT 20 DOES SAY "REPORT ON .MR. JOHN GRASSO," AND IT 21 SAYS SAh 22 A. THAT'S RIGHT. ASI-PR 0004393 23 Q. S. EPSTEIN, M.D., AUGUST 13, 1974. 24 WHETHER WE CALL THIS DOCUMENT A REPORT CR NOT, 25 I'D LIKE TO ASK YOU 4 FEW QUESTIONS ABOUT IT. CROSS D R . EPSTEIN - M3 3 S y \* < i 5 E M 1^2 1 IF YOU WAVT TO C*LL IT a P3 S L I<M T "AR Y REPORT, 2 FINE? 3 A. 4 Q. BY ALL MEANS. ON PAGE NINE OF THAT REPORT, YOU 5 STATE: THE FIRST REPORT OF CARCINOGEN IS 6 FREE OF VINYL CHLORIDE CREATE LITTLE IMPACT. 7 THIS WAS BECAUSE VIOLA HAD CLAIMED THAT THE 8 TYPE OF TUMORS INDUCED WERE PECULIAR TO RATS 9 AND WITHOUT HUMAN SIGNIFICANCE AND ALSO 10 BECAUSE THE VERY HIGH LEVELS OF VC TO WHICH 11 THE ANIMALS WERE EXPOSED. IS THAT A CORRECT 12 statement? 13 A. 14 0. I THINK SO, YES. THE DISCLOSURE THAT 3.F. GOODRICH 15 MADE ABOUT THE THREE CASES THAT DOCTOR CREECH 16 A.-.D DOCTOR JOHNSON FOUND, WHO WAS THAT 17 DISCLOSURE MADE TO, IF YOU KNOW? 18 A. AS FAR AS I RECALL, THIS WAS A 19 PU3LIC DISCLOSURE. AND I'VE FORGOTTEN WHETHER 20 THE MANUFACTURING CHEMISTS' ASSOCIATION MAO E 21 THE DISCLOSURE OR 9.F. GOODRICH. I THINK IT 22 WAS PROBABLY 3.F. GOODRICH'S DISCLOSURE. 23 Q. AND THE INFORMATION THAT WAS 24 DISCLOSED WAS UNCOVERED AS A RESULT 0* 25 MEDICAL ANALYSIS AND RESEARCH BY DOCTOR ASI-PR 0004394 cro S 5 - OR EPSTEIN MR. RE^NSISEN 15 1 C.iEcCH AND TO A DEGREE DOCTOR JOHNSON, TOWARD 2 THE END OF 1975; ISN'T ThAT TRUE? 3 A. I DON'T THINK SO. I THINK THIS WAS 4 IN JANUARY, 74, THE PU3LIC ANNOUNCEMENT WAS 5 MADE. 6 0. I'M SORRY. PUBLIC ANNOUNCEMENT IN 7 JANUARY, 74 AND THE INFORMATION THAT THEY 8 GATHERED, THEY BEGAN TO GATHER THE MONTH 9 3 E F 0 R E, DECEMBER, 73; IS THAT CORRECT? 10 A. WELL, I CAN'T TELL YOU EXACTLY WHEN 11 THEY STARTED DOCUMENTING THE HUMAN CANCER 12 CASES. CERTAINLY ONE KNOWS THAT THE 13 .MANUFACTURING CHEMISTS ASSOCIATION HAD 14 INFORMATION ON THE -- DETAILED INFORMATION 15 ON CARCINOGENICITY ABOUT TOWARDS THE END Or 16 1972. SO, THAT INFORMATION ON CARCINOGENICITY 17 WAS KNOWN FOR ABOUT 1 R MONTHS BEFORE. 18 Q. WHAT WE'RE TALKING ABOUT IS THE 19 GOODRICH -- DO YOU KNOW WHEN DOCTOR CREECH 20 GOT TOGETHER THE INFORMATION THAT HAS 21 SUBMITTED TO THE PUBLIC IN JANUARY OF 1974? 22 A. KNOW. 23 Q. AGAIN, IN YOUR REPGRT -- I THINK 24 IT'S ON PAGE FIVE AND MAYBE YOU DON'T HAVE TO 25 FINO IT -- l BELIEVE YOU STATED THAT VINYL ASI-PR 0004395 t C.% u S3 - 0 R t^STc In MR. 3 N N I S E N l iO 1 A. YEArl. 2 Q. AND I 3ELIEVE YOU HAVE TOLD `IE THIS 3 IS A GOVERNMENT PUBLICATION? 4 A. YE.AH. I *M NOT ABSOLUTELY SURE. I 5 THINK IT'S A C.D.C. DOCUMENT, 3UT I'M REALLY 6 NOT 100 PERCENT CERTAIN. 7 Q.. WELL, AT THE VERY E^D, IT SAYS 8 "ADDRESS ALL CORRESPONDENCE FOR CENTER FOR . 9 FOR DISEASE CONTROL." 10 A. YEAH, I'M PRETTY SURE, YEAH. 11 Q. AT THE ENDS OF THE CHRISTINE ARTICLE, 12 ON PAGE 215, THERE'S AN EDITORIAL NOTE. WOULD 13 THE EDITORIAL NOTE BE DOCTORS WITH C.D.C.? 14 A. I IMAGINE SO. SURE. 15 Q. NOW, AT THE TOP OF THE SECOND COLUMN 16 IN THE EDITORIAL NOTES, IT SAYS IN ABOUT THE 17 SIXTH OR SEVENTH LINE, "WHILE THESE FIMOImgS 18 ESTA3LISW NO CAUSAL CONNECTION BETWEEN 19 EXPOSURE TO PVC AND ANGIOSARCOMA Oe THE LIVE, 20 THEY DO RAISE THE POSSIBILITY OF SUCH A 21 RElATIONSHIP ." 22 A. SURE. 23 U* DO YOU AGREE WITH THAT STATEMENT? 24 A. WELL, I DON'T THINK IT'S POSSIBLE TO 25 TALK A30UT CAUSAL RELATIONSHIPS ` IN ABSOLUTE ASI-PR 0004396 cr SS DR. E S T E IX 'A 2 ' E N N E I S E * 1*1 1 TERMS. I THINK ALL YOU can TALK ABOUT I c 2 PR03A3LE ASSOCIATIONS, the HOST ? R 0 3 A B L E, THE 3 MOST LIKELY. THIS IS IT IS WAY IN WHICH all 4 CAUSALITY IS ATTRIBUTED IN MEDICINE. IF YOU 5 KrvOW OF S0MS300Y WHO OIES OF LUNG CANCER AND 6 HE SMOKED FIVE PACKS OF CIGARETTES A DAY, IT 7 WOULD BE A RASH, A SCIENTIFICALLY RASH PERSON 8 TO SAY HIS LUNG CANCER WAS ABSOLUTELY CAUSED 9 BY THE SMOKING. SO WE'RE TALKING ABOUT MOST 10 PROBABLE ASSOCIATIONS, AND THE STRENGTH OP 11 THESE ASSOCIATIONS BECOMES GREATER THE Mnog 12 CASES THAT A PE AR IN THE LITERATURE. 13 Q. . -BUT HERE WE'RE TALKING ABOUT THE 14 WORD POSSIBILITY. I MEAN, YOU HAVE TALKED 15 A30UT PROBABILITY 3UT HERE THE AUTHORS OF THE 16 EDITORIAL NOTE W-*0 YOU HAVE SAID ARE THE 17 DOCTORS AT CENTER FOR DISEASE CONTROL SAY,*' 18 "THESE FINDINGS ESTABLISH NO CAUSAL 19 CONNECTION BETWEEN EXPOSURE TO PVC AMO 20 ANGIOSARCOMA OF THE LIVER, THEY DO RAISE THE 21 POSSIBILITY OF SUCH A RELATIONSHIP.** / 22 POSSIBILITY IS LESS THAN PROBABILITY, ISN'T 23 I T? 24 A. YES, IT IS. BUT l WOULDN'T USE THF 25 WORD POSSIBILITY. I WOULD USE THE WORD asI_PR 0004397 3 S DR. EPSTEIN - HR . R E N >i I S S N 132 PROBABILITY AND, IN FACT, THE AUTHOR OF THE REPORT GOES FURTHER THAN THIS. Q. DOCTOR CHRISTINE GOES FURTHER? A. YES. FOR INSTANCE, IF YOU LOOK AT THE THIRD PARAGRAPH, TWO OF THE PATIENTS Q. THIRD PARAGRAow, THAT'S ?AC< ON 3AG E 2 1-0? A. LET'S GSt'thE APPROPRIATE PLACE. Q. ALL RIGHT, I'M LOOiCING AT IT. TELL HE WHAT YOU MEAN. OR READ IT TOO ME, IF YOU wAi\T to. A. SURE. Q. THE FIRST SENTENCE SAYS,"TWO OF THE PATIENTS APPEAR A. NO, THAT'S OCCUPATIONAL. 3 UT ON PAGE 213, ANOTHER TWO PATIENTS WHO HAD NO OCCUPATIONAL EXPOSURE WAD SEEN LONG-TIME RESIDENTS. AND THEM IT GOES ON TO SAY HAD LIVED FOR 35 YEARS, NO HISTORY OF OCCUPATIONAL* -- THEY arc RASICALLY REPORTING ANGIOSARCOMAS IN RESIDENTS NEAR VC PVC PLANTS'wHQ HAD NO OCCUPATIONAL EXPOSURE. This IS 3ASICALLY WHAT THEY'RE DOING. YOU'RE NOT DISCUSSING -- IT'S A CASE REPORT, WHICH IS EXACTLY -- THEY SAY THEY FOUND AN ASI-PR 0004398 CR SS 0R. EPSTF [V - . ? ENNE I S EN 1 1 ANGIOSARCOMA IN A v/OMAN WHO LIVED NEAo f\ 2 PLANT AND A COUPLE OF PEOPLE 'iuO LIVEO 'I CAP A 3 plant WHO had NO OCCUPATIONAL exposure and 4 THAT'S SASICAL.LT ALL THEY REPORT. 5 Q. SO, THE AUTHOR ISN'T REALLY 6 EXPRESSING AN OPINION ONE WAT OR ANOTHER OF 7 POSSIBILITY OS PROBABILITY. THEY'RE 8 DESCRIBING A CASE? 9 A. THIS IS A CASE REPORT, I THINK. 10 THAT'S THE 9 E ST WAY OF DESCRIBING IT. 11 Q. 1*0 LIKE TO REFER YOU TO THE ARTICLE 12 IN THE BRITISH MEDICAL JOURNAL, OCTOBER 3, 13 1-3 7 7 , WHERE PETER J . 3 AXTgS IS THE FIRST 14 AUTHOR. 15 A. SURE. 16 Q. DO YOU HAVE THAT REPORT? 17 A. I THINK SO, HOLD ON A SECOND. I 18 THINK SO. YES. 19 Q. NOW, ON PAGE 13 AT THE BOTTOM OF 20 TOUR -- NOT THIS REPORT 3 UT OF YOUR REPORT 21 OR YOUR PRELIMINARY REPORT TO THE TOP OF PAGE 22 19, YOU COMMENTED ON THIS ARTICLE BY PETER J. 23 BAXTER. AND YOU OBSERVED TAT A REVIEW OF 14 24 CASES OF ANGIOSARCOMA DIAGNOSIS? IN GRS*T 25 BRITAIN, 19R3 TO 1975 ASI-PR 0004399 CRi S S JR EPSTEIN R S \ .N E I S = N 1 i4 1 A. 2 q. I'M SORRY, WHAT PAGE M AS THAT. I AM MOW 3 A. 4 Q.` OH,.13, SURE, I'VE GOT YOU. 0 IAGNOSI ED IN GREAT BRITAININCLUDED 5 ONE CASE WHERE THE INDIVIDUAL INVOLVED WORKED 6 IN A PLANT THAT USED PVC AS RAW MATERIAL. AND 7 I -3ELIEVE YOU ARE REFERRING TO THE BAXTER 8 ARTICLE FOR THAT INFORMATION; IS THAT TRUE? 9 A. YOU'VE LOST ME NOW. WE'RE TALKING 10 ASOUT THE 9AXTER ARTICLE. 11 Q. FIRST I'M TALKING A30UT YOUR 12 REFERENCE TO IT. 13 A. SURE. AND WE'RE TALKING NOWA30UT 14 RESIDENTS. ARE WE TALKING ABOUT ANGIOSARCOMA 15 IN RESIDENT'S OR ARE WE TALKING ASOUT LATENCY? 16 Q. WELL, LET'S FIRST GO TO YOUR REPORT. 17 A. 18 0. OKAY, FINE. AUGUST 13, 19*0. 19 A. YEAH. 20 C. AT THE BOTTOM OF PAGE IR, YOU SAY, "A 21 REVIEW OF 14 CASES OF HEPATIC ANGIOSARCOMA 22 DIAGNOS I ED' I N GREAT BRITAIN DURING 19R3-1973 23 FOUND ONE CASE WHO HAD FORKED IN A PLANT 24 WHICH USED PVC AS RAW .MATERIAL," ANO YOU SAT 25 BAXTER 1977. ASI-PR 0004400 3 S DR . EPSTEIN! MR . REMNEISEN 135 A. YEAH. 0. AND THE BAXTER 1 G 7 7 IS THE ARTICLE,' IS IT NOT, IN THE BRITISH MEDICAL JOURNAL DATED OCTOBER A. THAT SRIGHT, TES. Q . E I GHT A.- RIGHT. 0. .NOW, REFERRING TO THE BAXTER ARTICLE, ISN'T IT TRUE, DOCTOR, THAT THE BAXTER ARTICLE REPORTED ON THE FINDINGS OF A PANEL OF DOCTORS WHO REVIEWED 14 -- IM SORRY, REVIEWED 41 DEATH WHEN THE DEATH CERTIFICATE MENTIONED A DIAGNOSIS OF ANGIOSARCOMA OF THE LIVER. A. I T HIN < SO, YES, I THINK THAT WAS WHAT THEY DID. Q. ISN'T IT TR'JE, DOCTOR, THAT THE PANEL AGREED ON ANGIOSARCOMA OF THE LIVER AS A DIAGNOSIS IN 14 Or THE CASES? A. I THINK SO, YES. THAT'S TABLE TWO, YES, ONE, TWO -- YES. Q. N<5W, I'M REFERRING TO PAGE 921 OF THE ARTICLE, THE SECOND PARAGRAPH IN THE RIGHT-HAND COLUMN. AND I ASK YOU, ISN'T IT TRUE THAT THE PANEL AGREED ON ANGIOSARCOMA Oe ASI-pR 0004401 C I'J ss DR. E P S T E IN - i\o REnNE ! SS' t 1 7 nE LIVES DIAGNOSIS -- I 'M 5 C3 RY. STRIKE 2 THAT QUESTION 3 ISN'T IT TRUE THAT ONLY ONE 4 CASE OF ANGIOSARCOMA OCCURRING 1953 TO 1973 5 COULD 3 E CONFIDENTLY ATTRIBUTED 3Y THE PANEL 6 TO VINYL CHLORIDE? V 7A * YES. 8 Q. NOW, IF WE L00< BACK TO PAGE 920 IN 9 THE SECOND COLUMN, THE SECOND PARAGRAPH UNDER 10 CASES AGREED 3Y THE PANEL, IT SAYS ONE HAD 11 BEEN A PROCESS WORKER IN PVC MANUFACTURE 12 EXPOSED TO LEVELS OF VCM EXCEEDING 200 PARTS 13 PER MILLION OVER 20 YEARS. DOESN'T IT? 14 A. YEAH. 15 Q. 16 A. AND THAT'S THE ONE CASE, IS IT NOT? JUST TELL ME WHERE YOU ARE ON THE 17 ARTICLE NOW. I'VE LOST YOU. 18 Q. I'M ONPAGE 920 OF THE ARTICLE. 19 A. YEAH. 20 Q. THE SECOND COLUMN, THE SECOND 21 PARAGRAPH UNDER THE HEADING, ''CASES AGREED S Y 22 THE PANEL." ANO I'M READING ONE HAD BEEN A 23 PROCESS WORKER IN PVC MANUFACTURE EXPOSED TO 24 LEVELS OF VCM EXCEEDING 2 0 0 PARTS E R MILLION .25 OVER 20 YEARS. ASI-PR 0004402 - 0*. EPSTEIN - MS. R E M N E I SEN 1 A. UM-HUM. AND. q. I'M ASKING YOU ISN'T TMAT THE ONE CASE TALKED A>3OUT SY BAXTER? A. NO, THIS IS A TARLE TWO WHICH HAS WHICH HAS ALL THE CASES CLASSIFIED 3T THE PANEL AS ANGIOSARCOMA OF THE LIVER. Q.' THAT'S RIGHT. 3 UT AT THE CONCLUSION, THEY SAID ONLY OnE CONFIDENTLY COULD 3E ATTR I 3JTABLE TO VCM? A. YES, 3ECAUSE ONLY ONE WAS -- AT THAT TIME TO HAVE LIVED -- TO HAVE WORKED IN PVC AND VC KIND OF PRODUCTS. Q. AND THE' ONE THE AUTHORSCONFIDENTLY ATTRIBUTED TO VCM WAS A MAN WHO HAD WORKED IN PVC MANUFACTURE AND WAS EXPOSED TO VCM AT LEVELS EXCEEDING 230 PARTS ER MILLION FOR ` OVER 20 YEARS; ISN'T THAT TRUE? A. THAT'S RIGHT, YES. Q. SC, HE WAS NOT A PVC FABRICATOR, HE AS ACTUALLY A PvC MANUFACTURER WORKING WITH THE RAW VINYL CHLORIDE; ISN'T THAT TRUE? A. WELL, IN THIS -- IN THE TA9LE, THEY TALK A30UT A FIBER GAS WORKER WORKING WITH PVC PASTE, THAT WAS THE MAN I WAS .REFERRING TO. ASI-PR 0004403 5 - DR PSTE IN MR . R 5mvp ! S EN 1 0. 3UT THE AUTHOR SMD O'lLY 0\E was A. I UM3EQSTAN0 YOUR QUESTION. ?JT I ' hREFERRING TO -- TABLE TWO GIVES A LISTING OF ALL THE CASES OF ANGIOSARCOMA. ON THE RIGHT-HAND COLUMN, IT GIVES STATEMENTS OF EXPOSURE TO VCM, ONE OF WHOM WAS OBVIOUSLY A PVC FABRICATOR, WHICH IS V/HAT I REPORT. Q. THAT *S. RIGHT. BUT THAT GENTLEMAN, ACCORDING TO THE AUTHORS OF THIS ARTICLE COULO NOT CONFIDENTLY BE CONSIDERED TO BE HAVE THE DISEASE CAUSED BY VINYL CHLORIDE; IS.N.T THAT TRUE? A. I THINK THAT IT IS A PARTIAL TRUTH, BECAUSE THEY GO TO SAY, THE POSSIBILITIES REMAINS ThAT THE, ANGIOSARCOMA OF THE LIVER ASSOCIATED *ITH -- WELL, IN THE LAST PARAGRAPH, THEY SAY, ONLY ONE CASE COULO 3E CONFIDENTLY ATTRIBUTED. Q. ALL RIGHT. A. AND THEN THEY GO ON TO SAY ONE PATIENTS WAS SUSPECTED. HE HAD LIVED THE COURT: DOCTOR, THE QUESTION TO YOU WAS BY MR. RENNEISEM: Q. WHICH CASE CONFIDENTLY CAN BE SAID aSI-pR 0004404 C.V4 ss DR. EPSTEIN MS. RENNEISE** l i? 1 TO a E 8 Y THESE TO BE ATTRIBUTED VINYL 2 CHLORIDE? 3 A. THEY CAME TO THE CONCLUSION THAT THE 4 ONE WITH VERY HIGH EXPOSURE LINES, THEY WERE 5 CONFIDENT OF THIS. BUT FOR OTHER CASES, THEY 6 clearly raised the possibility or probability 7 OF A RELATIONSHIP SUCH AS COMMON ITY OR OTHER 8 KINDS OF EXPOSURE. THEY TALK A 3 OUT ANOTHER 9 HAD LIVED FOR SIX YEARS 10 Q. THAT'S TRUE. 11 A. -- NEAR THE PLANT. 12 q. I RECOGNIZE THEY DISCUSS THE MAN 13 THAT HAD SIX -YEAR EXPOSURE. 3UT THE MAN THAT 14 THEY SAID CONFIDENTLY HAO A CAUSAL 15 RELATIONSHIP WAS A .MAN WHO HAD 20 YEARS 14 EXPOSURE TO 17 A. THERE'S NO QUESTION AT ALL. IT'S 18 MUCH EASIER TO MAKE A CONFIDENT STATEMENT OF 19 STRONG PROBABILITY IF SOMEBODY HAD BEEN 20 WORKING INSIDE A PLANT. UNTIL RELATIVELY 21 RECENTLY, THE LITERATURE HAS ONLY OUST 22 RECENTLY recognized THE WHOLE AREA OF 23 COMMUNITY HAZARDS. AND THIS IS -- THIS IS A 24 CASE IN POINT. THEY CONCLUDE THAT THERE WAS 25 ONE CASE WHO HAD NO OCCUPATIONAL EXPOSURE, ASI-PR 0004405 CRG SS DR. EPSTEIN - MR . R = N N E I S E N 17 n 1 WHO LIVED NEA? A PLANT, HAD ONLY LIVED NEAR A 2 PLANT FOP. SIX YEARS AND DEVELOPED 3 A N I OSARCOrtA. AND NO HISTORY Or OTHER 4 EXPOSURE TO THOROTRAST. 5 NOW, THIS ISN'T A CONFIDENCE. 6 THIS IS A STATEMENT OF WHAT I WOULD CONSIDER 7 PROBABILITY. 8 Q. THE AUTHORS DIDN'T EVEN SAY 9 PROBABILITY, DID THEY? 10 A. WELL, THE AUTHORS MAKE IT CLEAR THAT 11 THEY CONSIDER THESE TO EE ASSOCIATED. THEY 12 SAY IN THE TABLE, EXPOSURE TO VINYL CHLORIDE 13 LIVED NEAR PVC PLANT. THAT IS FAIRLY EXPLICIT. 14 Q. THAT'S AN EXPLICIT STATEMENT OF 15 where he lived, but it ib -- 16 A. NO, IT ISN'T. IT'S A STATEMENT OF 17 EXPOSURE TO VI it T L CHLORIDE. THEY HAVE A TA.3LE 18 WHICH SUMMARIZES DETAIL -- TA3LE TWO, 19 DETAILS OF ALL CASES CLASSIFIED 3Y THE PANEL 20 AS ANGIOSARCOMA OF THE LIVER. THEY HAVE ON 2T THE RIGHT-HAND SIDE COLUMN EXPOSURE TO VCM. 22 THEY HAVE ONE, YES, PROCESS WORKER, YES; THE 23 OTHER POSSI3LY PVC PASTE. HE WAS THE 24 FABRICATOR. THE OTHER, LIVED NEAR PVC 3 L A V T. 25 THE AUTHORS MAKE IT VERY ASI-PR 0004406 cro 5 5 - oa EPSTEIN H. a N N E I S 5 N l7I 1 ClEAR TnAT THEY REGARD nAD THESE AS SOURCES 2 OF EXPOSURE TO VINYL CHLORIDE. 3 NOW, HAVING SAID THEY WERE 4 EXPOSED TO VINYL CHLORIDE, THEY WENT ON TO 5 SAY, WELL, OBVIOUSLY, THE GUY WHO WORXEQ IN 6 THE PLANT, WE CAN BE MORE CERTAIN ABOUT 7 MAXING INFERENCES THAN IT IS OTHERS. 8 Q. THE ONLY -- DOCTOR, am I CORRECT, 9 THE ONLY MAN THAT THEY SPECIFICALLY IDENTIFY 10 15 THE MAN WHO HAD A 20 TEAR EXPOSURE OF 203 11 PARTS PER MILLION? 12 A. THAT IS NOT TRUE. ON PAGE 91, THEY 13 IDENTIFY ANOTHER WHO HAD LIVED FOR SIX YEARS 14 WITHIN A HALF MILE OF A PLANT MANUFACTURING 15 PVC AND IN THE TA3LE, THEY REFER TO THIS AS 16 EXPOSURE TO VCM, A CASE OF MAN AGED 70 WHO 17 AGE 61 WHO DIED IN 1070 WHO WAS A 18 CASHIER AND WHO HADN'T WORXED IN THE PLANT * 19 BUT LIVED NEAR THc PLANT. AND THAT IS 20 FALL.S INTO WHAT I THINX IS PROPER TO REGARD 21 AS A COMMUNITY CANCER CASE. 22 Q. CAN YOU POINT OUT. TO ME ANYPLACE IN 23 T Ml5 REPORT WHERE THEY SAY THE PASTE WCRXER'S 24 ANGIOSARCOMA WAS PROBABLY OR POSSIBLY CAUSED 25 3Y VINYL CHLORIDE, WHERE THEY USE EITHER OF ASI-PR 0004407 c r; DR . EPSTEIN M?. RENNEISEN 1 72 l THOSE WORDS? 2 A. THE TABLE IS VERY EXPLICIT. OVER 3 AND ABOVE THE T A 3 L E , THEY HAVE A WHOLE 4 PARAGRAPH ON LEVELS OF VI\YL CHLORIDE IN THE 5 ATMOSPHERE UP TO HALF A MILE AWAY FROM THE 6 FACTORY. THEY PRESENT MEAN LEVELS OF VINYL 7 CHLORIDE IN THE ATMOSPHERE UP TO HALF A NILE 8 AWAY FROM THE FACTORY FROM WHERE THE 9 NEIGHBORHOOD CASE OF ANGIOSARCOMA OF THE 10 LIVER OCCURRED, WHERE THE NEIGHBORHOOD CASE 11 OF ANGIOSARCOMA ARE CONSIDERED TO 36 SO AND 12 SO AND MAY HAVE 3EEN SEVERAL TIMES HIGHER IN 13 THE PASSENGER, INDICATING THE ORDER OF 14 EXPOSURE OF PEOPLE LIVING CLOSE TO FACTORIES 15 MANUFACTURING PVC. 16 Q. DOES THE ARTICLE 17 A. SO, IT IS CLEAR THAT THEY CONSIDERED 18 THIS TO 3E A COMMUNITY CANCER CASE. 19 Q. 20 A. IT'S CLEAR TO YOU * THEY MAY NOT HAVE USED YOUR LANGUAGE 21 OF POSSIBILITIES OR PROBABILITY OR MY 22 LANGUAGE. 'THEY REPORT THEIR FINDINGS. 23 THE COURT: LET * S NOT HAVE 24 THE ARGUMENT. JUST AS< THE QUESTION, YOU 25 RESPOND. ASI-PR 0004408 c R S - DR. EPSTEIN - 41. REVmcISEN 173 1 6 Y .4.1. R N N z I 5 N : 2 Q. 0 0C T 0 3 , I J 0N 1 T T H I N< W ' R E G0 I M S TO 3 ANSWER THAT QUESTION. WE'LL GO ON. 4 LET'S REFER TO THE BRADY 5 ARTICLE FOR A MINUTE. 6 A. SURE. 7 Q, THAT'STHE ARTICLE THAT APPEARED IN 8 THE GEORGE OF THE NATIONAL CANCER INSTITUT, 9 NOVEMBER, 1977. 10 A. SURE, I HAVE IT. 11 Q. 9EFORE WE GO ON, I WOULD IKE TO 12 MARK AS AN EXHIBIT -- AND AGAIN I DON'T 13 HAVE A CLEAN COPY, BUT I'LL GET ONE -- AS 14 Trie NEXT DEFENDANT'S EXHIBIT, THE BAXTER 15 ARTICLE. 16 THE COURT: DO YOU KNOW WHAT 17 NUMBER THAT IS?. 18 mr. remneisen: your honor, 19 I'LL WRITE ON HERE, D-A AND I'LL SUBSTITUTE A 20 CLEAN ONE FOR IT. I'LL WRITE D-'+ AND I'LL 21 WRITE "SUBSTITUTE CLEAN." 22 3T MR. RENNEISEN: 23 Q . NOW, REFERRING TO THE BRADY ARTICLE, 24 DOCTOR, THIS ARTiC'.E STUDIED 23 PATIENTS, DID 25 IT NOT? ASI-PR 0004409 cr 3 -DR. EPSTE IN - MR. R E N \ E I S E N 17 4 1 A. CORRECT. 2 0. ISN'T IT true tWAT 73 PERCENT OF the 3 23 PATIENTS STUDIED NAD NO DOCUMENTED DIRECT 4 EXPOSURE TO VINYL CHLORIDE, ARSENIC OR 5 THORIUM DIOXIDE? 6 A. N0, S IR . 7Q ISN'T IT TRUE THAT THE ARTICLE SAYS 8 DIRECT EXPOSURE TO THESE CHEMICALS COULD MOT 9 3 E DEMONSTRATED FOR 10 OF THE 23 PATIENTS? 10 A. THE ARTICLE SAYS THAT, 3 UTTABLE ONE n MARES IT VERY CLEAR THAT THAT ISN'T THE CASE 12 AND LET ME EXPLAIN TO YOU MY MEANING, IF I 13 MAY . 14 IF YOU TURN TO TABLE ONE, YOU 15 RILL SEE SEVEN CASES, THE FIRST SEVEN CASES 16 FOR WHICH THERE IS AN EXPOSURE HISTORY, 0<AY. 17 YOU WITH ME? 18 Q. YES? 19 A. FINE. HOWEVER,THERE'S ALSO ONE, TWO, 20 THREE, FOUR, FIVE, THE SUBSEQUENT FIVE CASES 21 BELOW WHO LIVED CLOSE TO A VC PVC FACTOR, 22 SEVEN PLUS -FIVE IS 12. TWELVE OUT OF 23 IS 23 43 PERCENT AS OPPOSED TO 27 PERCENT. 24 WHEN YOU SAIO THAT THERE'S NO 25 WHEN YOU INFER THERE'S NO ETIOLOGY IN IN ASI-PR 0004410 C V ss - J=. EPSTEIN - MR, RENNEISE'. 175 1 75 PERCENT -- I 73 PERCENT OF THE CASES, 2 TrIAT M E A N S THAT 27 PERCENT -- ONLY 27 3 PERCENT HAVE AN ETIOLOGY. MY POINT TO YOU 15 4 THAT LOOKING AT TABLE ONE, THEIR OWN TABLE 5 HAKES IT CLEAR THAT IN 45 PERCENT, HALF OF 6 THE CASES, THEY DIO HAVE AN ETIOLOGY; SEVEN 7 OF THEM, THE FIRST SEVEN AND THE LAST FIVE 3 WERE COMMUNITY RESIDENTS, PEOPLE WHO LIVED ' CLOSE TO VC PVC PLANT. SO, IN OTHER WORDS, 10 HALF OF THE CASES IN THIS A PS R HAD A HISTORY 11 OF EXPOSURE TO VINYL CHLORIDE. 12 NOW 13 Q. DOCTOR, YOU SAY -- . 14 THE COURT: JUST A MOMENT, 15 JUST A MOMENT. QUESTION. 16 3 Y MR. RENNSISEN: 17 Q. DOCTOR, DO YOU SAY THAT IN SPITE OF 18 THE AUTHORS SAYING DIRECT EXPOSURE TO THESE 19 CHEMICALS COULD NOT SE DEMONSTRATED FOR 37 20 PERCENT OF THE 25 CASES? A. WELL, IT'S DIRECT EXPOSURE. THE 22 POINT IS THAT IN TUE TABLE, THEY TALK ABOUT 23 EXPOSURE HISTORY. AND IN THE TABLE OF TABLE 24 ONE -/HERE THEY TALK A30UT EXPOSURE HISTORY, 25 IN 12 OF THE 25 CASES, THERE IS AN EXPOSURE 0004411 3 3 - D R. E P 5 T E I \ - HR E N E l S E' 17 1 history. 2 NOW, YTJ WANT "JSE 3 THE WORD DIRECT PQR THIS IS NETThp? NOR 4 THERE. THIS IS a report OF ?S CASES IN V/mo* 5 AT LEAST IN 12 OF THESE WE HAVE AN ETIOLOGY; 6 THE ETIOLOGY VARIES IN OIFcRENT ONES OF THEM, 7 3 J T THERE ARE FIVE CASES REPORTED HERE IN 3 WHICH THE ONLY KNOWN EXPOSURE WAS FROM 9 RESIDENTS IN The VICINITY OF VC PVC PLANT. I 10 HAY ALSO POINT OUT THAT THIS IS -- THE 11 FIGURES SHOULD REALLY BE 12 OUT OF 25, WHICH 12 HAKES IT UP TO 23 PERCENT. 3ECAUS IN ONE 13 CASE, THERE WAS NO RESIDENTS* HISTORY. SO, IN 14 FACT, IN 43 PERCENT OF THE CASES IN THAT 15 PAPER, THERE IS A KNOWN ETIOLOGY OR A 16 PRESUMPTIVE ETIOLOGY. 17 IN OTHER WORDS, DOCTOR, YOU DON'T 18 AGREE WITH THE FIRST PARAGRAPH OF ThE REPORT? 19 A. NO, THAT ISN'T THE CASE. IT HINGES 20 ON THE INTERPRETATION TO 3E USED ON EITHER 21 EXPOSURE ON THE ONE HAND OR DIRECT EXPOSURE. 22 THE TABLE _0.N= GIVES A HISTORY OF EXPOSURE 23 GIVES A COLUMN MARKED EXPOSURE HISTORY. * Q. LOOK, DOCTOR, DO YOU ASSUME THAT 25 EVERY CASE 0p VINYL CHLORIDE THAT OCCURS A$I-pr 0004412 CR 3 -DR. I J S T E Is: - *3 . 9 Ev '1E 1 S " N 17 7 1 [ T -I I N A ;11LE 09 TWO OF A PVC PLl'l 2 THE COURT: YOU MEAN EVERY 3 CASE OF 4 3Y hr. renneisen: 5 Q. I'M SORRY. DOCTOR, DO YOU EVER 6 ASSUME 7 MR. renneisen: HA.\`< YOU 8 JUDGE. 9 BY MR. RENNEISEN: 10 Q. DO YOU ASSUME THAT EVERY CASE 0* 11 ANGIOSARCOMA THAT OCCURS WITHIN A M f LE OR TWO 12 OF A "LANT IS CAUSED 3Y EMISSION FROM THAT 13 PLANT? 14 A. LET ME ANSWER YOU THIS WAY CLEARLY. 15 Ir ONE HAS AN ANGIOSARCOMA 16 OCCURRING l.N AN INDIVIDUAL WHO RESIDES CLOSE 17 TO A PLANT FROM WHICH DEMONSTRABLE EMISSION 18 THERE HAVE SEEN DEMONSTRABLE EMISSIONS 19 PVC EMISSION AND THE LONGER AND THE MORE 20 INTENSE AND THE MORE INFORMATION YOU HAVE ON 21 THIS, THE MORE CONFIDENT YOU CAN BECOME. 5(JT 22 THE TWO REQUIREMENTS FOR A DIAGNOSIS OF A 23 COMMUNITY ANGIOSARCOMA ARE, ONE, THE 24 DIAGNOSIS OF THE DISEASE IYSELF; Tv.-C, 25 HISTORY OF RESIDENTS CLOSE TO A Pl^NT; *'ID, ftSI-PR 0004413 t * crj 3 3 JR. EPSTEIN *. * R E N N E I S E ."I 17t 1 THREE, INFORMATION ON EMISSION FROM THE Pl_a\T. 2 AND IN THE GRAS SO CASE, w 3 HAVE ALL THESE THREE REQUIREMENTS: 4 ANGIOSARCOMA, RESI DENTS CLOSE TO Thf PLANT 5 AND DETAILED INFORMATION OF EMISSION ** A 5 ? D OM 6 MODELING AND OTHER DATA. SO, ME HAVE THESE 7 COM3 I NAT I ON OF THREE FACTORS AND THIS IS 8 PRECISELY WHY IN SCIENCE ONE DEVELOPS A BODY 9 OF INFORMATION FROM WHICH YOU HAKE INFERENCES 10 AND YOU DEVELOP UPON THESE PARTICULAR 11 RELATIONSHIPS. THIS GOES THE WAY WE KNOW 12 ABOUT THE RELATIONSHIP OF SMOKING AND LUNG 13 CANCER; FROM PROBLEMIST IC RELATIONSHIPS, NOT 14 BECAUSE OF ANY ABSOLUTE TERMS. 15 O. DOCTOR, W I TH RESPECT TO THE FIVE 16 PEOPLE REFERRED TO IN THE R R A D Y REPORT WHO 17 LIVED NEAR A PLANT, DO YOU HAVE ANY EMISSION 18 DATA? 19 A. NO, EXCEPT WHAT THEY SAY IS -- LET 20 JS SEE EXACTLY WHAT THEY SAY. OF POSSIBLE 21 IMPORTANCE IS THE FACT THAT THE A M 3 l E N T 22 EMISSION R OF VC MONOMER FOR THE FACTORY 23 LOCATED 1,700 FEET FROM THE RESIDENCE OF 24 PATIENT NUMBER TEN WERE AS HIGH AS 92,000 25 P.P.M.. THEY ALSO GO ON TO SAY -- a HERE IS ASI-PR 0004414 C R 5 -JR. EPSTEIN - MR . RENNEISE\ l ?0 1 ANG l C5ARCOMA? 2 A. I'Ve ALREADY ANSWERED THIS, I TMIK<, 3 3 ij T I 'LL REPEAT THE -- MY ANSWER: THAT THE 4 STRENGTH -- ASSURANCE OF MAKING STATEMENTS 5 OF P703A3ILITT DEPENDS, APART FROM THE 6 DIAGNOSIS OF ANGIOSARCOMA, DEPENDS ON 7 PROXIMITY OF RESIDENCE, AND ALSO THE TIME 8 5ECUENCE AMO FINALLY, INFORMATION ON EMISSION. 9 Q. 3 U T, DOCTOR 10 A. NO, I HAVE TO ANSWER YOU, 3ECAUSE 11 YOU'VE ASKED ME THIS THREE TIMES AND I 12 BELIEVE I'Ve ANSWERED THE SAME `WAY. 13 IF YOU HAVE INFORMATION ON M EMISSION OF VINYL CHLORIDE FROM THE PLANT 3Y 15 MODELING OR BY MONITORING, THEN THE STRENGTH 16 OF A. STATEMENT ON PROBLEMATIC -- ON 17 PROBLEMATIC RELATIONSHIPS BECOMES .STRONGER. 18 THIS IS EXACTLY WHAT WE HAVE IN GRASSO. WE 19 HAVE VERY DETAILED INFORMATION 20 THE COURT: I THINK THE 21 QUESTION HE'S ASKING YOU, DOCTOR IS A CAPABLE OF A RESPONSE, YES OR NO. READ THAT QUESTIQr.. I THINK THE DOCTOR CAN RESPOND YES OR NO. MR. RENNEISEn: THANK YOU, ASI-PR 0004415 YOUR HQ VO1* C C 0 U R T R E 0 R T E R READS 'ENDING QUESTION.) THE WITNESS: NOT IN ANY SITUATION. IN SOME SITUATIONS. MR. RSNNJEISEN: THAN A YOU, DOCTOR. 3 Y MR. RcNNEISEN: Q . AND IN THOSE SITUATIONS WHERE YOU HAVE MORE DATA; IS THAT CORRECT? A. IN PARTICULAR, WHERE YOU HAVE DATA ON EMISSION. IF, FOR INSTANCE, YOU HAD A PVC PLANT THAT WASN'T FUNCTIONING AND HAD NEVER FUNCTIONED, THEN I WOULD SAY -- I WOULDN'T BE WILLING TO A SC RI 3c A RELATIONSHIP. Q. LET. ME CHANGE THE QUESTION, DOCTOR. ARE YOU SAYING TnEN THAT IF YOU HAVE An ANGIOSARCOMA NEAR A FUNCTIONING PVC PLANT WITH EMISSION, THERE IS A SUSSTANTIAL PROBABILITY THAT THAT ANGI05ARC0MA -WAS CAUSED BY THE EMISSION FROM THE PLANT? A. Y.ES, ESPECIALLY IN THE A3SENCE OF EXPOSURE TO -- KNOWN EXPOSURE TO OTHER AGENTS INDUCING ANGIOSARCOMA. Q. NOW, I THINK WE -- WF ROTH AGREE, ASI-pR 0004416 5 - lr. ci-sr i: - ^- i2 - 112 iOCTjx, THAT IF YOU HAD A MAH LIVING OUT I * WYOMING AWAY FSOH EVERY P V C ^LAM A N D NEVER jScO A SPRAY CAN OF ANYTHING, HE COULD STILL HAVE ANGIOSARCOMA? A. CERTAINLY. I'VE ALREAOY DISCUSSED the four causes. 0. AND IF that gentleman has nQT EXPOSED TO THOROTRAST, VINYL C^LO^IOE, STEROID OS ARSENIC, HE STILL COULD GET A JG I OS ARCO.MA, COULDN'T HE? A. WELL, IF HE GETS ANGIOSARCOMA, HE GETS IT, SG, THEREFORE, THERE'S NO ARGUMENT A30UT IT. THE QUESTION IS WHAT IS THE CAUSE, g. WELL, YOU'VE ALREADY SAID, DOCTOR, THAT THERE ARE MANY CARCINOGENS NOT YET IDENTIFIED. A. WELL, WE HAVE FOUR <NOWN CAUSES OF ANGIOSARCOMA. I'M UNWILLING T0 EXCLUDE THE POSSIBILITY THAT AT SOE STAGE IN THE CUT'JIP, ANOTHER CAUSE -- I ' ** NOT GlTED 'WITH PROPHECY. ALL WE CAN SAY IS WE NOW <NDW OF THREE DEFINITE CAUSES OF ANGIOSARCOMA AND A FOURTH POSSIBLE CAUSE OF ANGIOSARCOMA. Q. AND TEN YEARS FROM NOW, :.'E MAY HAVE TEN CAUSES; ISN'T THAT TRUE? ASI~PR 0004417 5 S D R . EPSTEIN R E N N E I SEN <1. THAT 15 POSSIBLE. ^ UT I T ' 3 `OT PROPARLS. I * >'1 NOT WILLING TH EXCLUDE THAT POSSIBILITY. 0. IT'S NOT PR03A3LE? A. N0. Q. HOW MANY YEARS AGO THERE WERE NO K'SOrtT* A. . lS* THE REASON WHY IT'S NOT PR03A3LE THIS IS A VERY RARE CANCER AND THE OF THE RASE CANCERS OF ANG10SARCOMAS WHICH *'VE SEEN SO FAR, WE HAVE -- THE MORE WE EXAMINE THEM, THE MORE WE'VE SEEN ABLE TO DEVELOP INFORMATION ON ETIOLOGY. AND RAStCALLY, WHAT IS HAPPENING NOW IS THAT THE CASES OF. ANGIOSARCOMA THAT ARE DEVELOPING APE BEING EXAMINED MORE AND MORE CAREFULLY A\*3 CONSIDERATIONS SUCH AS PROXIMITY OF RESIDENCE IS NOW 3 E I N`G RECOGNIZED MORE AND MORE AND OTHER SuCh FACTORS OF IT. 0. WELL, DOCTOR, ARE YOU TELLl.vG M = *Th*T MORE as and more cases are BEING EXAMINED, PEOPLE LI<E YOURS ARE TRYING HARDER AND HARDER TO FIT THEM INTO ONE OF FOUR CATEGORIES? A. THAT'S NOT WHAT I 5*10. Thp ASI-PR 0004418 3 -03 EPSTEIN RSNNEISEN tltf SCIENTIFIC COfMJMTY 15 FAYING PARTICULAR atteht-ion to this, among other issues, ESPECIALLY 3 E C A u 5 E ANGIOSARCOMA HAPPENS TO BE A RARE DISEASE AND THEREFORE, IT'S EASIER TO 5 TOD Y. WHEN YOU HAVE A VERT COMMON CANCER LIKE LUNG CANCER, IT BECOMES FAR MORE DIFFICULT TO STUDY FROM THIS = 01MT Cc VIEW OF ASCRIBING CAUSALITY. W HEN IT COMES TO RELATIVELY UNUSUAL CANCERS#. LIKE MESOTHELIOMA FROM ASBESTOS OR ANGIOSARCOMA, IT THEN BECOMES EASIER TO TRY TO DEVELOP INFORMATION ON CAUSALITY. DOCTOR, WAS THERE A TIME WHEN THE nEDICAL PROFESSION HAD NO <NCw.N CAUSES FOR ANGIOSARCOMA? A. CERTAINLY. THE TESTS HADN'T BEEN J 01\ E IN ANIMALS ANO THERE MAD SEEN THE FEW CASES. THAT HAD OCCURRED IN THE M I CT-5 I XT I E 5 HAD BEEN MISS DIAGNOSIS?. 0. ANO AS DOCTOR LAUCIU5 WHO HAS HERE THIS MORNING SAID THAT ANGIOSARCOMA OF THE LIVER HAD BEEN KNOWN FOR C3 YEARS, DO YOU AGREE W I TH' THAT? A. I CAN'T TELL YOU THE DATE WHEN ANGIOSARCOMA WAS FIRST RECOGNIZED. I WOULD AsI-PR 0004419 -OR. E P 3 7 IN -MR. R N N E I S E N 125 HAVE TO GO 3AC!< TO THE LITERATURE. I KNOW IT'S 3EEN RECOGNIZED FOR SOME Tp'E, FOR DECADES. 3 UT I CAN'T REALLY TELL YOU THE DATE OF THE FIRST REPORT. 0. DOCTOR , ISN'T IT FAIR IF THERE WAS A TIME THAT IT EXISTED AND NOBODY CJEW ANY CAUSES AND THEN ONE DAY THERE WAS ONE CAUSE A 'iJ THEN THREE AmD NOW POSSI3LY FOUR? A. THAT'S CORRECT. Q. ANO ISN'T IT REAS0.NA3LE TO ASSUME, PARTICULARLY SINCE THERE SEEMS TO 3E NO RELATIONSHIP IN THE FOUR KNOWN OR SUSPECTED CAUSES WITH EACH OTHER, THAT THERE ARE PR03A9LT OTHER CAUSES; ISN'T THAT TRUE? A. WELL, I'M NOT WILLING TO EXCLUDE THAT AS A POSSIBILITY. ALL I CAN SAY IS THAT AT THE MOMENT, THREE DEFINITE CAUSES HAVE 3EEM DEMONSTRATED AND A FOURTH POSSIBLE CAUSE HAS BEEN DEMONSTRATED. THAT'S AS FAR AS AS ONE CAN GO IN THIS LINE. p. DIO YOU REFER TC THE -- I DOn''T THINK YOU REFER TO IT 3Y AUTHOR'S NAME. 3UT I thought rou were referring to an article 3y CHIAZZE ENTITLED MORTALITY AMONG EMPLOYEES OF PVC FABRICATORS? ASI-PR 0004420 CR 3 3 DR. E p S T E I \ >|3 R S '''4 E I S S N 1 * ' 1. a. I -JIDM'T LIST THAT f\ THE COMMUNITY 2 C4.\CER OR IN THE -- OR 1*4 Th= ONES .v l T H 3 LATENCIES UNDER TEN YEARS, NO, 1 OION'T LIST 4 THAT. 5 Q. OIO YOU REFER TO IT WHEN YOU WERE 6 TALKING ABOUT CASES IN FABRICATORS 7 A. THAT'S RIGHT. 8 0. -A WHERE THERE WAS EXPOSURES OF 9 ZERO TO TWO PARTS ER MILLION? 10 A. YES, IN THAT CONNECTION, I REFER TO 11 CHIAZZE. 12 Q. AND ON PAGE 10 OF YOUR REPORT, 13 REFERENCE IS MADE TO A CROSS-SECTION, 14 MORTALITY STUDY OF 3,?'*5 DEATHS AMONG 15 EMPLOYEES OF PVC FABRICATORS 9T LEONARD 16 CHIAZZE; ISN'T THAT TRUE? 17 A. THAT 'S TRUE. 18 Q. AND CHIAZZE IN fact, WITH H l 5 19 ASSOCIATES, NICHOLS AND WONG, DID, I-N PACT, 20 STUDY DEATH OF PVC FABRICATORS,DIO THEY NOT? 21 A. THAT`S RIGHT, YES . 22 Q. AND THSE ARE gentlemen op WOMEN WHO 23 TOOK POL Y VINYLChlCRIDE AND IN S CH PROCESSES, MANUFACTURED INTO PRODUCTS THAT WERE USED 25 TODAY? ASI-PR 0004421 DR. EPSTS IN MR. RENNEIScN 1-7 A. CORRECT. g, ISN'T IT TR'JE THAT DOCTOR CHIAZZE FOUNO NO ANGIOSARCOMA DEATH AMONG THE GROUP THAT HE STUDIED? % A. THAT'S RIGHT, HE FOUND VARIOUS OTHE3 CANCERS, 3 UT NO ANGIOSARCOMAS. Q. ISN'T IT TRUE THAT THE PRIMARY 03 J EOT IVE OF HIS STUDY HAS TO DETERMINE RELATIVELY QUIC<LY WHETHER OR NOT ANY Am* I 05 A.RCOMA DEATH COULD 3E IDENTIFIED AMONG THE STUDY GROUP? A. I REALLY DON'T RECALL. IT'S QUITE POSSIBLE HE TRIED TO DO THAT. 3UT ESSENTIALLY WHAT HE DID FIND WAS AN EXCESSIVE CANCER OF DIFFERENT MALIGNANCY. AND THIS HAS SEEN REPORTED IN SEVERAL OTHER STUDIES, TOO. C. WELL, IF YOU'LL TO PAGE *25 OF THE BOTTOM OF THE CHIAZZE ARTICLE A. REGRET. Q. I DON'T HAVE THAT IN FRONT OF ME, l I'M SORRY, I'LL GET YOJ OnE. THE COURT: YOU WANT SOME MORE WATER, DOCTOR. the witness: that would se S ICE, THAN* YOU. ASI-PR 0004422 f r 7oS 5 dr. epstein MR . 'E'INE ISE'l 1- 1 the witness I *5 n *i T , I SEE 2 He POINTS YOU ;t ERE MA<MG. 3 BY AH. RENNEISE\: 4 Q. AND HE DOES SAY, DOES HE NOT, ThE 5 PRIMARY STUDY OBJECT WAS TO DETERMINE 6 RELATIVELY qUlC<LY WHETHER ANY -- WHETHER 7 OR NOT ANY ANGIOSARCOMA DEATH 8 A. 9 Q. CORRECT. COULD BE 10 0. COULD BE IDENTIFIED AMONG THE STUDY 11 GROUP. 12 A. CORRECT. 13 0. AND WHEN he COMPLETED HIS OBJECT, HE 14 FOUND NONE, ISN'T THAT TRUE? 15 A. CORRECT. BUT OTHER CANCERS, WHICH 16 ALSO HAVE BEEN ASSOCIATED WITH VINYL CHLORIDE 17 EXPOSURE. 18 19 I q. NOW, YOU REFER TO A BAXTER AND FOX ARTICLE, DID YOU NOT? 20 ". YEAH. 21 Q. AND THAT IS INTHE LANCET, JANUARY 22 3 1, 1 9 7 S ,- ISN'T IT? 23 A. YEAH.HANG ON.0<AV, 24 0. AND I BELIEVE vOU SUGGESTED t^at 25 BAXTER AND e0X FOUND LUNG AMD 3RAtN CANCER : ASl-ppj 0004423 - DR. E ? S T E IN - /.a. R f N \ E I 5 M 1'; 15 THAT TRUE? A. I DON'T RECALL SAYING THAT. WHAT I LET'S JUST REFRESH MY MEMORY AND YOUR MEMORY, IF I MAY. Q. FINE, DOCTOR. A. FIRST OF ALL, I EF5* TO S A XT E R AS HAVING DESCR I9ED ONE COMMUNITY CANCER CASE 0s A LIVER ANGIOSARCOMA WITH A LATENCY 0* SIX YEARS IN SOMEBODY WHO LIVED WITHIN A HAL* MILE FROM A 3RITI5H PVC PLANTS. THAT'S ONE POINT I MADE. 0- IS THAT REFERRED TO IN THIS BAXTER AND FOX ARTICLE? A. I THINK SO. SURE. WAIT A SECOND. WE'RE LOOKING AT DIFFERENT 3AXTER ARTICLES. I THINK THAT'S THE BASIS FOR THE CONFUSION. I WAS* LOOKING AT BAXTER, ANTHONY, RODERICK, MC CUEEV, ET CETERA, WHICH IS BRITISH MEDICAL JOURNAL, OCTOBER, 177. I'M SORRY I MISLEAD YOU WITH THE REFERENCE. Q. I WAS TALKING ABOUT BAXTER AND FOX. A. WELL, MY REFERENCE THIS MORNING TO TnS -- MY REFERENCE PREVIOUSLY TO THE COMMUNITY CANCER AND. THE SHORT latency PERIOD *AS 3AXTER ET AL., 1977. I THINK THAT'S THE ASI-PR 0004424 OR. 5 ? S T S I M M 1 . R E v N = l S EN BASIS OF Ti? CONTUSION. SO, [ hAV5'T`-*5 BAXTER A SO FOX AST I C LS HERE, SURE. Q. AND YOU DIO REFER TO IT IM YOUR REPORT ON PAGE 19, DID YOU NOT? A . I T H l N .< SO . PAGE 19, NO . I REFER TO 3AXTER ET 4L., 77, NOT -- ANO THIS IS BAXTER 75, BAXTER ET AL. 77 IS THE -- IS THE ONE WITH THE COMMUNITY CANCER CASS'. 0. YOU ARE FAMILIAR WITH BAXTER AND FOX, ARE YOU NOT? A. I HAVE ROTH OP THEM [ m =RONT OF ME, SIR. Q. ALL RIGHT. NOW, IF u TAKE RAXTER AND FOX A. YOU SEE, ON =AGS 19, THERE'S TWO REFERENCES TO BAXTER. THAT'S THE PROSLEm. Q. I AM .REFERRING TQ THE LANCET, JANUARY 31, 1975 A. FINE. Q. BAXTER AND FOX TOWARD THE EnD. AND IT SAYS, "VINYL CHLORIDE HAS BEEN SUGGESTED AS CAUSING CANCEL Op THE LUNG AND BRAIN a WELL AS ANGIOSARCOMA OF T"S LINER AND OT'-tr-j ASI-PR 0004425 c pq ss - DP EPSTEIN r sen l'l 1 LIVE? DISEASES. IN THIS STUDY, TE 2 NUMRE* Or DEATHS p?Dm THESE CAUSES W E "> E '-:0T 3 IN EXCESS OF THOSE EXPECTED.'1 4 A. THAT'S RIGHT, Th A X * S CORRECT. f.JT 5 THERE HAVE 3 E EN A WIDE RANGE 0= OTHER ST'JDI-5 6 SINCE THEN WHICH HAVE DEMONSTRATED THAT THERE 7 AWE TARGET ORGANS BESIDES ThE LIVER AND THIS 8 IS WELL RECOGNIZED IN THE LITERATURE NOW. ? Q. DOES THE -- OID THE PEOPLE AT THE 10 CENTER FOR DISEASE CONTROL CONSIDER LUNG AND 11 BRAIN CANCER TO BE CAUSED 3Y VINYL CHLORIDE, 12 IF YOU KNOW? 13 A. . WELL, ALL I CAN TELL YOU -- I 14 HAVEN'T SEEN ANY CATEGORICAL STATEMENTS 01 15 THIS. BUT THE INTERNATIONAL AGENCY FOR ThP 16 RESEARCH ON CANCER, FOR WHICH C. 0 .C. IE 17 INVOLVED AS KINO OF A MEMBER ORGANIZATION, 18 clearly recognizes lung, brain and various 19 other SITES AS TARGET ORGANS FOR VINYL 20 CHLORIDE induced cancer. 21 0. YOU DO RECOGNIZE C.O.C. AS ANOTHER 22 AGENCY * H IC H SERVES A PURPOSE FOR THE .MEDICAL 23 COMHUN ITY AND COLLECTS INFORMATION AND MAKES 24 CONCLUSIONS? 25 A. CERTAINLY, I'M very familiar with ASI-PR 0004426 c? S5 epstein *9 . R E N Ne I s E - 1"2 1 T.i OPERATION OF C.O.C. C.O.C., I* pACT 2 ISN'T -- ITS PRIMARY EXPERTISE ISN'T l\ 3 CARCINOGENESIS. NATIONAL CANCER INSTITUTE ANO 4 NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETT 5 AND HEALTH HAS GREATER EXPERTISE IN THIS ARA 6 AND THE INTERNATIONAL AGENCY FOR THE RESEARCH 7 ON CANCER IS BASICALLY THE INTERNATIONAL 8 AUTHORITY ON THE R ECOGN I T I ON. ON RELATTONSHIPS 9 BETWEEN EXPOSURE TO CHEMICALS AND CANCER. AND 10 I SAID BEFORE, THERE'S A WIDE RANGE OF 11 PUBLICATIONS DEMONSTRATING THE INVOLVEMENT OF 12 ORGANS LKE LUNG AND 3RAIN AS A CARCINOGENIC 13 RESPONSE TO VINYL CHLORIDE. AND l HAVE MORE 14 Than -- i have literature here, if you wish. 15 g. HENRY FAULK IS WITH THE -CENTER FOR 16 DISEASE CONTROL? 17 A. THAT'S RIGHT, YES. 18 Q. AND DO YOU KNOW WHAT HIS POSITION IS 19 THERE? 20 a. I DON'T <NOW WHAT HIS "DSITtCN TS 21 NOW. 22 0. HAVE YOU MAD DEALINGS WITH HIM? 23 A. OH, YES, YES. 24 q . Wc TALKED EARLIER IN MY OUESTION 0* 25 YOU ABOUT HIS ARTICLE WHERE HE TALKS ABOUT ASI-PR 0004427 CRG ss - DR EP5TE IN iR . ^ 5 _ I $ -* Ihu 1 OP A SUBSTANTIAL PROBABILITY. ThEREFORF, I 2 CAN'T ANSWER Y 0 J AS TO WHAT PERCENTAGE OF THE 3 CASES HAS BEEN ArTRI3UT ED IM THE SAME WAY AS 4 THREE OR FOUR YEARS AGO. MOW WE*RE BEGINNING 5 TO SEE MORS AND MORE OF THEM. WE'RE GOING TO 6 SEE MORE ANO MORE LUNG CANCER, BECAUSE PEOPLE 7 ARE LOCKING FOR IT NOW. SO, THEREFORE, I'M 8 UNWILLING TO GIVE YOU AN ABSOLUTE FIGURE AS 9 TO THE PERCENTAGE- OF CASES OF ANGIOSARCOMA IN 10 WHICH AN ETIOLOGY HAS BEEN 0EMQNSTRATEO. THE n FIGURES IN THE LITERATURE SEEM TO SUGGEST 12 THE LITERATURE SEEMS TO SUGGEST ANYTHING 13 RANGING FROM 75 TO ABOUT 3 5, DEPEND ING ON 14 w H AT SERIES YOU LOOK AT. 15 Q. DOCTOR, IN MAKING YOUR ANALYSIS OF 16 CAUSE AND EFFECT, Or PROBABLE CAUSE AND 17 EFFECT BETWEEN VINYL CHLORIDE AND 18 ANGIOSARCOMA, YOU 3AS ICALLY ARE RELYING ON 19 DATA IN THE LITERATURE; ISN'T THAT TRUE? 20 A. CERTAINLY. DATA IN THE LITERATURE, 21 PLUS -- PLUS, SIR, INFORMATION ON THE 22 5PECICICS -OF MR. GRASSO'S EXPOSURE AND WHERE 23 ME LI'/EO. 24 0. BUT WITH RESPECT TO THE -- THE 25 CASES THAT YOU HAVE TOLD US ABOUT TODAY ASI-pR 0004428 CROSS U R . EPSTEIN MR. RENNEISEN 155 1 .nOT MR. BASSO'S CASE, 3UT THE ACCOUNTANT IN 2 CONNECTICUT AND THE 33 YEAR OLD wOMAN, 3 WHEREVER SHE LIVED, THOSE CASES YOU GOT FROM 4 THE LITERATURE. 5 A. CORRECT, SIR. 6 Q. YOU DIDN'T SEND OUT OUESTI 0 N N A IRES 7 YOURSELF TO PATHOLOGISTS AROUND T*E COUNTRY 8 AND COLLECT THE DATA YOURSELF? 9 A. 10 g. NO. IS THAT-RIGHT? 11 A. 12 q. NO. SO.THE PRINCIPAL SOURCE OF TOUR 13 INFORMATION ARE ARTICLES WRITTEN BY OTHER 14 REPUTA3LE DOCTORS WHO HAVE THEM PURL I SHED IN 15 REPUTABLE JOURNALS? 16 A. 3UT LET ME MAKE IT CLEAR THAT WHEN 17 YOU GO TO THE SCIENTIFIC LITERATURE, YOU 18 DON'T NECESSARILY GO THERE LOO<ING *OR 19 OPINIONS. YOU GO THROUGH LOO<ING "OR FACTS. 20 HAT I'VE GOT OUT Or THE LITERATURE ARE FACTS 21 AND TnE FACTS ARE THIS: THERE ARE A WIDE 22 RANGE OF C-ASES OF ANGIOSARCOMA IN PEOPLE 23 LIVING CLOSE TO PLANTS, ONE. 24 TWO, THERE ARE ANGIOSARCOMAS 25 A.SO OTHER .MALIGNANCIES IN PEOPLE LIVING CLOSE ASI-pr 0004429 S3 DR. p S T E I 'J M3. RENNEISEN I" TO PLANTS AND PEOPLE W 0 3 !< I MG ' W I T^ f *o >j 5 T 3 I 5 S IN SHORT LATENCIES. THREE, WE KNOW HE LIVEO HERE A PLANT. WE KNE'w THERE WERE A LOT OF EMISSIONS. SO, WE KNOW NATIONAL ENVIROmENTAL Q. EXCUSE ME, DOCTOR. DO YOU KNOW WHAT QUESTION YOU'RE ANSWERING. BECAUSE I DON'T.. A. I CAN TELL YOU THE OUESTION THAT YOU ASKED ME IS WHAT INFORMATION I GOT eROM THE LITERATURE WHICH ENABLES ME TO COME UP WITH INFERENCES IN THIS AREA. Q . MAYBE WE'LL GO BACK TO THE QUESTION, DOCTOR. OR LET'S GO ON. A. SURE. Q. I THINK I A.SKEO, DO YOU RELY ON Th LITERATURE. I DON'T THINK I ASKED YOU WHAT A. I SEE. I RELY ON THE FACTS IN THE LITERATURE. Q. ALL RIGHT. YOU RELY ON THE FACTS IN THE LITERATURE. A . YES . 0 . T*ERE IS L I TEP ATtjRER WHICH INDICATES, SAY, A POCKET OF PEOPLE IN WISCONSIN WM E R E ASI-PR 0004430 C R J|S S OR. ipsrs in MR . RSNNe I 5SN l'7 1 TnERE'5 NO PLANTS AT ALL AND THERE'S AN . 2 UNEXPLAINED GROUPING OF ANGIOSARCOMAS; ISN'T 3 THAT TRUE? 4 A. YES, tHE MARSHALL FIELD CLINIC AREA. 5 0. THAT'S RIGHT. ANO THAT'S OTHER DATA 6 THAT TOU CONSIDER 7 A. HOST CERTAINLY. 8 Q. AND AGAIN, THE DATA THAT TOU ARE 9 CONSIDERING, WHETHER IT 9S OPINIONS or facts 10 COMES OUT OF THE LITERATURE THAT TOU READ? 11 A. CORRECT. 12 HR. RENNcISEN: THANK YOU, 13 DOCTOR. THAT'S ALL I HAVE. 14 THE COURT: ANY REDIRECT? 15 16 YOUR HONOR. MR. VASSALOTTI: JUST A FEW, 17 3 Y MR. VASSALOTTI: 18 0. DOCTOR, THERE'S SEEN SOME TESTIMHNY 19 A30UT THE STEROIDS. I DON'T RECALL THE FULL 20 NAME' OP THE STEROIDS? 21 A. ANA3OL it STEROIDS. 22 Q. THAT ARE A P0SSI3LE -- IMPLICATED 23 AS A P 0 S $ I 3 uc CAjSE OF ANGIOSARCOMA OF THE 24 LIVER. 25 DOCTOR AS PART OF THE ASI-PR 0004431 I RECT DR. EPSTEIN - M vassalqtt r T 1* M A T E R l A L 5 THAT WERE PROVIDED T3 YOU WI ~H REGARD TO INFORMATION ON THE MEDICAL HIS'ORY OF HR. GRAS SO, OIO YOU RECEIVE LETTERS FROM THREE OF NR. GRASSO'S PERSONAL PHYSICIANS THAT DATE 3AC< TO 1353? A. YEAH, I'VE SOT SEVERAL LETTERS ON T r> 1 5 AnO, YEAH, I'VE SOT THREE LETTERS, THAT'S RIGHT. 3. ANO DO THOSE LETTERS PURPORT TO DESCRIBE ALL THE MEDICATION0* DRUGSTHAT WERE ADMINISTERED OR PRESCRIBED TO HR. SRASSO 9 Y THOSE DOCTORS? A. THAT'S CORRECT. Q. ARE THERE MR. RENNE ISEN: I OBJECT TO this line of questio?^ing. The COURT: I'LL SUSTAIN THAT. .MR. VASSALOTTI: . EXCUSE Me, TOJR HOnOR. THE COURT: SUSTAIN THE OBJECTION. MR. VASSALOTTI: YOUR HONOR, MAY JE APPROACH THE 3 ENCH? THE COURT: SURE. CSIDE BAR ON RECC'D.5 ASX-PR 0004432 .'< c J I RECT DR. EPSTEIN MR. VASSAlOTTI l99 1 MR. V A S 5 AL OT T f: FIRST, I '0 2 L l < E TO NO WHAT THE 5AS 1S OF THE OBJECTION IS, 3 THE COURT: I ASSUME IT'S A 4 HEARSAY OBJECTION OF THE CASES. 5 MR. RENNEISEN: IT'S HEARSAY 6 AND IT DOESN'T c A !_L IN THE MEDICAL RECORD 7 EXCEPTION BECAUSE THEY WERE NOT MADE FOR THE 8 PURPOSE OF TREATMENTS. THEY Wr RE G IVEM TO 9 THIS DOCTOR FOR THE TESTIFYING. 10 THE COURT: I ASSUMED THAT 11 WAS .THE SASIS HE WAS OBJECTING ON. 12 MR. VASSALOTTI: THERE IS A 13 RULE, AS I UNDERSTAND, ON THE FEDERAL RULES 14 OF EVIDENCE, IF DOCTOR EPSTEl'N SAID HE WOULD 15 RELY ON INFORMATION LIKE THIS, THEN -- 16 THE COURT*. WELL, IT WOULD BE 17 USED NOT FOR THE TRUTH. HE WAS BEGINNING TO 18 ASK HIM -- 19 MR. RENNEISEN: IT'S -- IT 20 DOESN'T GET INTO EVIDENCE UNDER T"E HEARSAY 21 RULE. MR. VASSALOTTI: I UNDERSTAND 23 The RJLtS -- AS AN EXPERT, IF HE WOULD RELY 24 UPON STATEMENTS BY A MAN'S aS RSQnAL PHYSICIAN 25 AS TO THc TYPE OF MEDICATION THAT WAS ASI-pr 0004433 I RECT 0 R . EPSTEIN MR. VASS4U0TTI 2 O'* PRESCRI3ED TO THAT man n\ THE WAYS 0 = D E T R.M I N I NG WHAT CAUSED THE -AN'S CANCEL, UNDER THE FEDERAL RULES OF EVIDENCE, THAT'S AN EXPERT'S REPORT UPON THIS: THE COURT: LET HE ASK YOU have you seen the letters? MR. RENNET sen: NO, SIR. THE COURT: WHY DON'T YOU SHOW HIM THE LETTERS? MR. RENNEISEN: THAT'S NOT GOING TO CHANGE MY OPINION. THE COURT: I UNDERSTAND. MR. vassalotti: JUDGE, I CAN TE;; YOU, I WROTE TO THP =HYSICIANS, WILL YOU PLEASE TELL ME EVERY OR'JG YOU PRESCRIP ED ON This MAN. THE LETTERS WERE SENT to ME. I SENT THEM TO DOCTOR EPSTEIN. MR. RENNEISEN: THAT CONFIRMS THE 3 * 5 I $ FOR MY OBJECTION. IF YOU'RE GOING TO PROVE HE HAD NO STEROIDS, YOU'VE GOT TO BRING THOSE DOCTORS IN. the court: let me as< you THIS: INFORMATION WAS GIVEN TO THIS WITNESS ON WHICH HE 3ASEO HlS OPINION, TOO, FROM EXPERTS WHICH IT'S TECHNICALLY HEARSAY ALSO, ASI-PR 0004434 1 I RECT DR. EPSTEIN MR . V A S S A L D T T I 231 T*jO . mr. aENNE i sen: .;0 3oor OBJECTED. THE COURT: WELL, I'M GOING TO REVERSE MYSELF AND ALLOW TT I OPEN COURT.) CTHE FOLLOWING TAKES PLACE IN 3 Y MR. VASSALOTTI : 0. DOCTOR, DID YOU REVIEW THE LETTERS FROM, I BELIEVE IT WAS DOCTORS ROZANSKI, DE PERSIA AND GILPATRICK? A. YES, SIR. Q. WAS THERE ANY INDICATION tN ANY OF those letters that mr. grasso received any STEROIDS? A. N0, S I R . Q. DOCTOR, DURING YOUR CROSS-EXAMINATION, YOU MENTIONED THAT E.P.A. ENACTED A NATIONAL EMISSION STANDARD FOR THE EMISSION OF VINYL CHLORIDE IN -- l Thim< P WAS OCTOBER OF 1<7R? A. THAT'S CORRECT. 0 . ARE YOU CA.H I L IAR WITH THE FI\0!S'GS THAT THE ENVIRONMENTAL PROTECTION AGENCY HADE AND RELIED UPON AND UPON WHICH THEY BASED ASI-Pr 0004435 RE 1 RECT J R PS TE IN ;ia vassalott r 202 1 THEIR STANDARD? 2 A. YES, I WAS A ME MAE 9 OP AN P . ? . A 3 ADVISORY COMMITTEE THAT CAME UP with THIS 4 RECOMMENDATION AT TWE TI ME. 5 Q. CAN YOU DESCRIBE =09 US THE "IMDINGS 6 THAT WERE MADE BY E.P.A. AND UPON WHICH THEY 7 3A S THEIR CONCERN A30UT EMISSION OF VINYL 8 CHLORIDE? 9 A. 10 YES, 1 THINK I CAN. MONITORING STUDIES 3Y THE 11 environmental protection agency in 1374 mao 12 DEMONSTRATED AVERAGE LEVELS OF 17 PARTS PER 13 3ILLTON IN THE VICINITY OF A RANGE OF PLOTS. 14 IT WAS ASSUMED -- IT WA 5 BELIEVED that FOUR 15 POINT SIX MTLLION PEOPLE IN Tc ijnTTSD STAt!S 16 WERE LIVING IN THE VICINITY OF PLANTS Wl^H 17 EXPOSURES ON THE AVERAGE -- I 9 EG YOUR 18 PARDON -- OF A3OUT 17 PARTS 3ER BILLION. ' 19 q. THAT'S PER BILLION? 20 A. .?E1 BILLION I'M T A L .< I N G ABOUT NOW. 21 THE ENVIRONMENTAL PROTECTION AGENCY ESTIMATED 22 THAT WITH J.HIS LEVEL OF EXPOSURE, ONE COULD 23 ANT 1C I PATE BETWEEN -- 24 MR. RENNEISEN: YOUR HONOR, 25 AT THIS POINT, I OBJECT. IT'S THE OPINION OF ASI-PR 0004436 f t t rs i I R ECT DR. EPSTEIN - M V*SSAL'Tt i 2? 3 1 A ?.s. GULATGR r AGENCY W I TH -- 2 THE WITNESS: THESE ARE 3 FIGURES -- 4 MR. VASSALOTTI: TOUR HONOR, 5 IT'S EXACTLY THE POINT. IT'S A FINDING OF A 6 GOVERNMENT AGENCY AND IT CLEARLY FALLS WITHIN 7 THE EXCEPTION OF RULE 3039. 8 THE COURT: ALLOWED. 9 OVERRULED. LET'S PROCEED. 10 THE WITNESS: THE 11 ENVIRONMENTAL PROTECTION AGENCY CALCULATED 12 THAT t I TH THIS < I NO OF LEVEL OF EXPOSURE, 13 THEY COULD ANTICIPATE 3 E TWEEN CESS THAN ONE 14 AND TEN ANGIOSARCOMAS A YEAR. FOR THESE 15 GROUNDS, THEY FElT IT WAS ESSENTIAL TO REDUCE 16 THE LEVELS Or VINYL CHLORIDE EMISSION. THE 17 NEW STANDARD OF THE ENVIRONMENTAL PROTECTION 18 AGENCY WAS DESIGNED TO REDUCE ThE EMISSION 3Y 19 30 PERCENT. 20 NOW, VIE WERE TALKING THERE 21 ABOUT 17 PARTS PER BILLION. AND CM THE 17 22 ARtS ER BILLION LEVEL SREAD OVER FOUR 23 POINT SIX MILLION PEOPLE, UP TO TEN 24 ANGIOSARCOMAS A YEAR WERE ESTIMATED. WE'RE 25 NOW TALKING IN THIS INSTANCE -- WELL, ASI-PR 0004437 U1 1 SECT DR. SPSTEIM MR. VA SSALOTTI 2 0V 1 PERHAPS THIS ISN'T -- This ISN'T IN 2 response to the question. 3 THE COURT: WELL, LET IT RE 4 IN RESPONSE TO Tg-S QUESTION, OR OTHERWISE YOU w 3 CAN'T. 6 3 Y MR. VASSALOTTI : 7 C. THAT WAS NY NEXT QUESTION, DOCTOR, 8 THE E.P.A. CONSIDERED LEVELS OF 17 PARTS PER 9 3ILLIQN IN THEIR FINDINGS UPON WHICH THEY 10 3*S THEIR STANDARDS; IN THIS CASE -- AND 11 IS IT TRUE THAT 3AS ED UPON THOSE LEVELS OF 12 EXPOSURE, THE E.P.A. CONSIDERED THAT THERE 13 WAS AN EXCESS 'RISK OF ANGIOSARCOMA AS A 14 RESULT OF THE VINYL CHLORIDE EXPOSURE? 13 A. 16 0. CORRECT, SIR. AND THE LEVELS WE'RE TALKING A 3 0 U T 17 IN THIS CASE ARE IN THE PARTS PER MILLION -- 18 WHEN I SAY THIS CASE W E 'RE TALKING AEOUt 19 SRA5SO -- THAT YOU'RE RASING YOUR OINI0N 20 0 '1? 21 A. 3AScO ON THE DATA WHICH HAVE SEEN 22 SUdMlTTEO TO ME 5Y DOCTOR PESKlN, THAT 23 APPEARS TO 6 E THE CASE. EVEN THE DAMES AND 24 MOORE DATA wOULD 3E. C0NSISTENT wITH THE 25 ESTIMATE OF THE E.P.A. ASI-PR 0004438 IRECT - DR. EPSTEIN - MR. VA35ALOTTI ?0 THE COURT: ANYTHING FURT-pr? MR. VASSALOT7I: TOUR HO'Oe , EXCUSE ME. BY MR. VASSALOTTI: Q. DOCTOR EPSTEIN, THERE HAS BEEN SOME MENTION OF ARSENIC 3 EI MG USED IN PESTICIDES. DO YOU HAVE ANY INFORMATION RELATING TO SHOWING THAT. ARSENIC OR ARSENIC COMPOUNDS CONTAINED IN PESTICIDES ARE CAUSEDLY RELATED TO ANGIOSARCOMA OF THE LIVER? A. ARSENIC CERTAINLY IS A CAUSE OF ANGIOSARCOMA. AND IF TH ARSENIC IS ---WHETHER IT*S CONTAINED IN A PESTICIDE OR ANY OTHER PRODUCT, I WOULD CERTAINLY wIS* TO CONSIDER THIS. Q. DOCTOR, IF -- AND I SAY tF 3ECA-JSE IT h A 5 fc * T BEEN SHOWN -- SOMEONE LIKE MR. 5RA5SQ HAO BEEN EXPOSED TO SOME UNKNOWN LEVELS OF PESTICIDES THAT CONTAINED ARSENIC AND WAS THEN EXPOSED TO THE VINYL CHLORIDE THAT WE'VE TALKED A30UT IN THIS CASE, IS THERE ANY MEDICAL EVIDENCE OR SCIENTIFIC EVIOENCE TO INDICATE THAT Tmc TWO CANCER CAUSING AGENTS WOULD WORK TOGETHER? A. WELL, LET ME ANSWER THIS GENERALLY ASI-PR 0004439 REJ I RECT DR. EPSTEIN - hr. vassalotti ;o' i A.'.u THEN SPEC I F I CALLY . FROM A GENERAL - 2 STANDPOINT, WE HVE VERY, VERY substantial 3 literature to show the effects of a chemical 4 CARCINOGEN. IT CAN BE WHAT WE CALL SINOGISEO. 5 THAT'S THE EFFECTS CAN BE MULTIPLIED BY 6 EXPOSURE EITHER BEFORE 0 AFTERWARDS TO 7 ANOTHER CHEMICAL OR TO ANOTHER CHEMICAL 8 CARCINOGEN. ANO THERE'S A LOT OF LITERATURE 9 ON THIS PRACTICE 10 BUT LET ME BE MORE SPECIFIC 11 AS FAR AS VINYL.CHLORIOE IS CONCERNED. 12 THERE'S ONE VERY CRITICAL 13 EXPERIMENT WHICH I VERY MUCH REGRET THAT I 14 NEGLECTED TO INFORM THE COURT ABOUT THIS 15 MORNING WHICH YOU JUST TRIGGERED ME. AND THAT 16 IS A STUDY BY A DOCTOR RADICKE FROM 17 CINCINATTI WHICH WAS REPORTED AT THE 18 CONFERENCE, A GOVERNMENT CONFERENCE ON VINTL 19 CHLORIDE IN THE SPRING OF 1 <* R 0. AND WHAT SHE 20 OIO .7 AS QUITE FASCINATING IN THIS CONTEXT. 21 SHE TOOK SOME RATS, SPAYEO OR NEUTERED RATS 22 AND DOSED THEM WITH ALCOHOL, NONE 23 > 0 N - C A R C I NOGEN. SHE THEN GAVE THE RATS WHICH 24 h E R c DOSED WITH ALCOHOL SOME VI\YL CHLORIDE. 25 A*Q THE RATS WHICH HAD VINYL CHLORIDE WITH ASI-PR 0004440 ECT DR . EPSTEIN MR. VASSALOTTI 217 1 ALCOHOL PRE-TRE AT^ENT GOT A 5INOGISTK F=*ECT 2 1M DELATION TO TWO THINGS: A VERY, V=RY, 3 marked increase in the incidence of 4 ANGIOSARCOMA AND AN INCREASE IN HEMATIC 5 CANCERS WHICH ARE OIFFER FROM ANGIOSARCOMAS. 6 SO, THE PRE-TREATMENT, THE MODEST 7 PRE-TREATMENT OF THE RATS WITH THE EQUIVALENT 8 OF A FEW DOUBLE MARTINIS AND WHAT HAVE YOU 9 I HAVEN'T TRANSLATED THE DOSE INTO EXACT 10 ALCOHOL CONCENTRATIONS -- MASSIVELY 11 SINOGISED THE INCIDENCE OF ANGIOSARCOMAS OF 12 THE LIVER IN RATE AND ALSO HEPATIC CANCER. 13 the court: could you define 14 SINOGISEO 30 EVERYONE KNOWS WHAT THAT TERM IS. 15 THE WITNESS: I*M SORRY, I 16 SHOULD HAVE DEFINED MY TERMS. LET US SAY YOU 17 HAVE AM AGENT -- LET'S SAY YOU GIVE 18 S0ME300Y -- YOU GIVE A POPULATION OF RATS A 19 DOSE OF ONE CARCINOGEN WHICH GIVES THEM TEN 20 PERCENT CANCER, OKAY, AND A DOSE OF ANOTHER 21 CARCINOGEN WHICH ALONE WOULD GIVE FIVE 22 PERCENT. Sa, YOU'D EXPECT WHEN YOU PUT THE 23 TWO TOGETHER, YOU'D GET 15 PERCENT, WOULDN'T 24 YOU. THAT WOULD EE AN ADDITIVE EFFECT. t = nj 25 PERCENT OF CANCER IN ONE SET OF EXJERTS. YTJ  V t # rR EeJjiIsReEcCtT - DOR'*. EPSTEIN - iM'i RR-. VA S 5 AL 3T T I 23' jcT TEN PERCENT FROM THE CHEMICAL. A *1 OTHER SET OF EXPERTS, YOU GET ANOTHER FIVE PERCENT. 3 BUT, IN FACT, WHEN YOU PUT THE TWO TOGETHER, 4 IF YOU GET 15 PERCENT, THAT MEANS IT'S A 5 MULTIPLICATIVE ACTION OR SINOGIST EFFECT. SO, 6 A SINOGISTIS EFFECT IS GREATER than YQU COULO 7 ANTICIPATE FROM THE MERE ADDITION OF THE TWO 8 THINGS TOGETHER. SO, ALCOHOL *Y Itself IS 9 THE LITERATURE ON THE CARCINOGENICITY OF 10 ALCOHOL IS COMPLEX WHICH I REALLY WON'T 11 OS VOTE any TIME TO. 3UT A SMALL PRE-TREATMcNT 12 jkITH ETHYL ALCOHOL PRODUCED A VERY, VERY MAJOR INCREASE IN THE CARCINOGENIC EFFECTS OF 14 VINYL CHLORIDE. 15 NOW, FOR THIS REASON, I THINK 16 WHAT WE -- WHAT WE NOW HAVE TO CONSIDER IS 17 WHETHER -- THE POSSIBILITY AS TO WHETHER IF 18 HE HAD EXPOSURE TO ARSENIC OR IF HE 4A0 19 EXPOSURE TO OTHER CARCINOGENS OR SOME NON- * 20 CARClNOGEMS AT DUPONT, W"ETHER THESE MIGHT 21 22 | POSSIBLY HAVE CONTRIBUTED SOMEWHAT. WE'RE DEALING WITH A PRIME CAUSE WHICH IS THE VINYL 23 CHLORIDE. IN MY OPINION, THE VINYL CHLORIDE 24 IS THE AGENT FOR WHICH THERE IS A SUBSTANTIAL 25 PROBABILITY. BUT I'M UNWILLING TO EXCLUDE THE ASI-PR 0004442 I 7ECT DR. EPSTEIN M 7. VASSALOTTl 200 FACT THAT AN.EXPOSURE OF PIH7 EXPOSURE TO ARSENIC- 07 P 7 10 7 EXPOSURE to SOME OF THESE 0THE7 AGENTS MAY HAVE MAO AM ADDITIONAL CONTRISUTORY ROLE. AND ONE' REASON WE MAY WISH TO CONSIDER THAT IS BECAUSE OF THE WHOLE HISTORY. WE DO <N0W AT DJPONT, HE WAS EXPOSED TO OTHER CHEMICALS, ALTHOUGH MY LEVEL OF INFORMATION ON THE NATURE OF THIS EXPOSURE IS NOT OF A HIGH ORDER. NONE OF THESE AGENTS WHICH HE WAS EXPOSED TO AT OUPQNT WERE KNOWN TO INDUCE ANGIOSARCOMA OF THE LIVER, HOWEVER. THE COURT: LET * S PROCEED. MR. VASSALOTTl:* I HAVE NOTHING FURTHER, YOUR HONOR. THE COURT: REDIRECT RECROSS. MR., rennsisen: thank you. 7 E C 7 0 S S-E XAH INA TI ON 3 Y MR. RENNEISEN: s* THERE, THIS SINOGISTIC EFFECT YOU JuST TALKED A30UT, THAT APPLIES TO EVERY30DY, DOESN'T IT, NOT JUST MR. GRASSC? A. WHAT APPLIES TO EVERY3Q3T? Q. A SINOGISTIC EFFECT WHEN THERE'S A CERTAIN COMBINATION OF CHEMICALS OR DRUGS IS ASI-PR 0004443 RED ROSS OR. EPSTEIN R.. RENNEISE'* 2 1 ", 1 A CONDITION TnAT 15 PRESENCE Pi RATS A NO 2 PEOPLE AN 0 CHIMPANZEES A NO EVERYONE ELSE, ' 3 ISN'T IT? 4 A. YOU CAN DEMONSTRATE SINOGISTIC 5 EFFECTS. 6 Q. IN ANYBODY, ISN'T THAT TRUE? 7 A. IF ONE HAS THE APPROPRIATE 8 CONDITIONS FOR THE INDUCTION OF THE 5IN0GISM, 9 SURE. TOO MUCH EXPOSURE TO A PARTICULAR 10 CHEMICAL CARCINOGEN WHICH INDUCES A 11 CARCINOGENIC EFFECT AND IN AOOITIOM TO THAT, 12 SOME OTHER CHEMICALS CAM SINOGISE. AND WE DO 13 HAVE THE LITERATURE ON THIS 30Th IN ANIMALS 14 AND HUMANS. I DON ' T KNOW IF THIS IS WHAT 15 YOU ' RE ASKING ME. 16 Q . THAT'S FINE, DOCTOR. HO* MANY CASES 17 OF ANGIOSARCOMA DID TfjE E.P.A. FIND WITHIN 18 THOSE FOUR POINT SIX MILLION PEOPLE WHO LIVE 19 AROUND PVC PLANTS? 20 A. I DON'T THINK AT THE TIME THEY H^O 21 DONE ANY STUDIES. THEY WERE -- THAT 22 PARTICULAR - -- THAT REPORT, The SO CALLED 23 STAR REPORT IN 1T75, 5*51CALLY DID TWO THINGS: 24 IT LISTED ALL THE KNOWN CASES OF ANSIOSARCjHA 25 A.,0 17 INCLUDED Also THOSE Two CASES WITH ASI-PR 0004444 r ea *o5 s OS. EPSTE IN MS. RENUEISEN 2I 1 1 SHORT LATENCY PERIODS AND ALSO THEY REPORTED 2 ON MONITORING AND MODELING STUDIES. AND AMONG 3 OTHER THINGS, IT REPORTED OM A STUDY BY Th 4 AMERICAN PU3LIC HEALTH ASSOCIATION ON THE 5 NUMBER OF PEOPLE LIVING IN THE VICINITY OF 6 PLANTS. THEY PUT ALL THE DATA TOGETHER AMD 7 SAID ON THE 3 A 5 IS OF O'JR MONITORING DATA, WE 8 THINK THAT THE LEVELS OF VINYL CHLORIDE IN 9 PEOPLE LIVING CLOSE TO VINYL CHLGR1DE PLANTS 10 IS ON THE AVERAGE 17 PARTS PER BILLION. WE 11 ESTIMATE ON THE BASIS OF THE AMERICAN PUBLIC 12 HEALTH ASSOCIATION DATA FOUR POINT SIX PEOPLE 13 LIVE IN THESE AREAS. THEY PUT THE TWO 14 TOGETHER AND THEY CAME UP WITH THESE 15 EST IMATES. 16 NOW, I * M WILLING TO CRT'ICIZE 17 THESE ESTIMATES. I THINK IT'S VERT DIFFICULT 18 TO MAKE THESE QUANTITIES TAKE THE DIFFERENT 19 ESTIMATES. 3 UT THE 3 E ST GOVERNMENT ESTIMATES 20 AT THE TIME WAS wE CAN ANTICIPATE IN THE 21 COMMUNITIES BETWEEN LESS THAN ONE -- HE 22 OION'T SAY HOW MUCH LESS THAN ONE JP TC TEN. 23 THAT *'S A BROAD RANGE. `WHEN IT'S LESS THAN ONE, 24 IT COULD BE ZERO POINT ZERO ZERO ONE. GOD 25 KNOWS. 3 UT THEY WERE CONCERNED ABOUT IT ASI-PR 0004445 >05S - O' E P S T E I N M R R = >: 'i E l 5 E \* ?17 if.O-Jii.l TO SAT 0,\ THE MAS IS of these FINDINGS, c ARE DETERMINED TO U I H I T THE AMOUNT OF EMISSIONS rao.1 PVC 90 PERCENT. Q. AND YOU WEREN'T CONSULTANT AT THAT TIME? A. I WAS OPERATING ON E.P.A. AT SEVERAL I WAS A CONSULTANT ANO EXPERT WITNESS IN THEIR SPECIAL CANCER HEAR[NTG5 ON ESTICIOES 9 UT I WAS ALSO A MEMBER OF THE ENVIRONMENTAL HEALTH ADVISORY COMMITTEE ANO 4 SUBCOMMITTEE WHICH WAS CONSIDERING SOME OF T5 DATA WHICH WE WERE LOO<ING AT. Q. AFTER THIS ESTIMATE WAS MADE, OIO anybody go out and fino out how many cases these were? A. rfE'RE DOING JUST THIS <IND OF THING NO*, BECAUSE THERE HASN'T BEEN Q. WHO IS WE?. A. 'court WE ARE CONSIDERING HERE IN THIS THE COURT: TO < M 0 W WHO IS WE. I THIN< HE WANTS THE WITNESS: WE IN THIS COURT, SIS, ARE CONSIDERING JUST ONE OF Tm E 5 E CASES, NAMELY A MR. GRAS SO. ASI-PR 0004446 *E<BRC5 5 0R . P5TE IN MR. SEN'JcISc'i 2I5 1 6 T MR. R 5 N N E l S E N : 2 Q. YOU -1EAN I N THIS- ROOM? 3 A. WE ARE CONSIOERING ONE COMMUNITY'S 4 CANCER CASE. THESE. HASN'T BEEN A SYSTEUZED 5 5TUOY OF THIS WHOLE PROBLEM OF COMMUNITY 6 CANCER. BUT THE ENVIRONMENTAL ROTECTI3N 7 AGENCY WAS CONCERNED SIX YEARS AGO 3Y THE 8 FACT THIS THIS LEVEL OF EXPOSURE COULD 9 PRODUCE UP TO 120 CANCERS EVERY YEAR. NOW, 10 IT'S IN ADDITION TO 11 Q. IT'S PRODUCED TEN CANCERS? 12 A. WELL, THIS WAS THEIR ESTIMATE. 13 SHORTLY AFTER THAT, LEVELS WERE PRODUCED. NOW, 14 THERE HAVE 3 EEN STUDIES WHICH I REFERRED TO 15 THIS HORNING,, QUITE APART "ROM THE 18 ANGIOSARCOMAS OF EXCESS BRAIN TUMORS 0* 17 LIVING IN THE V ICINITY OF PLANT. NOW, I CAM ' T 18 GIVE YOU ABSOLUTE CLEARCUT ANSWERS TO THESE 19 THINGS 3ECAUSE WE DON'T <NOW. ALL w <N0W IN 20 THIS CASE IS SOMEBODY WAS EXPOSED TO LEVELS 21 OF VINYL CHLORIDE WHICH APPEAR TO HAVE 3EEN A 22 GREAT DEAL' HIGHER THAN THOSE WHICH CONCERNED 23 TriE ENVIRONMENTAL PROTECTION AGENCY SO MUCH 24 AS TO ORDER INDUSTRY TO REDUCE ITS EMISSION 25 BY SO PERCENT. THAT SPEAXS FOR ITSELF. ASI-PR 0004447 ?=c ROSS 07. E D S T E IN *4* . BENNEISEN 21u 1 Q. ALL RIGHT. I HcA<?0 YOU s,\Y TUAT. H*S 2 A.NY3O0Y CHECKED THAT DATA? DO ifE, TH 3 IwrGRMED PUBLIC, THE DOCTOR EPSTEINS OF THE 4 WORLD, THE MEDICAL COMMUNITY, E.P.A., KNOW 5 HOW HANY ANGIGSARCGMA-5 ARE IN THAT GROUP OF 6 PEOPLE? 7 A. ONE OF THE THINGS IN THIS COUNTRY IS 8 WE DON'T HAVE A NATIONAL TUMOR INDEX. WE 9 DON'T <NOW THE CAUSE OF DEATH OF EVERYBODY IN 10 THIS COUNTRY. WE DON'T HAVE AN AUTOPSY Oe 11 EVERYBODY IN THIS COUNTRY. PEOPLE -- IT'S 12 IMPOSSIBLE TO ANSWER THAT. WE DO HAVE SURVEYS. 13 FOR INSTANCE, THE T.H IR 0 NATIONAL CANCER 14 SURVEY OR THE SEARS PROGRAM. THESE ARE BASED 15 ON TEN PERCENT OF THE AMERICAN POPULATION. IN 16 CONNECTICUT, YOU HAVE A GOOD TUMOR REGISTRY. 17 I CAN'T ANSWER YOU THESE QUESTIONS, BECAUSE 18 * DON'T HAVE A DATA 3 A NIC IN THIS COUNTRY 19 WHICH GIVES YOU INFORMATION ON 3IRTH TD DEATH, 20 INCLUDING AUTOPSY ON EVERY SINGLE ONE OF THE 21 220 MILLION AMERICANS. 22 Q. WAS ONLY ASKING ABOUT FOUR MILLION 23 FOUR POINT SIX MILLION PEOPLE That t 24 THOUGHT THAT YOU AND THE E.P.A. WERE 25 CONCERNED ABOUT. ASI-PR 0004448 REq ROSS JR. EPSTEIN hr. renneisen 21 5 1 A. SIR, WE DON'T HAVE A DATA RAN.< 2 COVERING THE WHOLE OF THE U.S. THERE ARE 3 CONCERNS OVER A WIDE RANGE OF ISSUES, NOT 4 ONLY THE VINYL CHLORIDE ISSUE. THE CONCERN 5 THEN RELATED TO FOUR AND A HALF *MLLIOM 6 P 0LE AND I THINX I'M REING REPETITIVE AND 7 THE CONCERN WAS ADEQUATE TO RESULT IN THIS a REDUCTION OF EMISSION. RUT THERE HASN'T EEN' 9 A SPECIFIC FOLLOW UP OF THESE FOUR POINT SIX 10 MILLION PEOPLE. THERE HASN'T SEEN A DETAILED 11 FOLLOW UP OF THEM. THERE HASN'T SEEN A FOLLOW 12 UP OF THE PEOPLE WHO WERE GIVEN VINYL 13 CHLORIDE AS AN ANESTHETIC AGENT. 14 0- SINCE THERE'S NO FOLLOW UP TO FIND 13 OUT WHAT HAPPENS TO THIS FOUR POINT SIX 16 MILLION PEOPLE, IS IT FAIR THEN, DOCTOR, TO 17 SAY, WE DON'T <NOW WHETHER THERE'S A HIGHER * 18 INCIOENTCE OF ANGIOSARCOMA CLOSE T0 POLYVINYL 19 PLANTS OR NOT? 20 A. I TH I N< ON THE EASIS OF THE 43SENCS 21 OF INFORMATION, THE ANSWER WOULD 3 YES. 22 HOWEVER, AS I'VE INDICATED, l GAVE YOU A LIST 23 OF A WHOLE SERIES OF ANGIOSARCOMAS, WHICH HAD 24 OCCURRED IN PEOPLE LIVING IN THE VICINITY OF 25 PLANTS. THAT IS ASX--PR 0004449 1RF ross 1 0. OR. E P S T E t N - MR RENNE I -5 EM ?1c YOU* VE GIVEN V! E 1 Cl4T OUT OF c0UR 2 POIMT FOUR MILLION PEOPLE? 3 A. NO, SIR, I HAVEN'T. I * V GIVEN YOJ 4 EIGHT OUT Or A VERY SMALL NUM3E.R 0P THE TOTAL 5 NUM3E.R OF ANGIOSARCOMAS WHICH ARE RECOGNIZED. 6 OF THE TOTAL NUMBER OF ANGIOSARCCiAS THAT ARE 7 RECOGNIZED, WS HAVE, I WOULD SAY, A FAIRLY 8 SUBSTANTIAL NUMBER OF COMMUNITY CANCERS. .9 Q. HOW MANY OUT OF FOUR POINT SIX 10 MILLION? 11 A. FOUR POINT SIX MILLION IS YOUR 12 OENOMI NAT I ON. 13 Q. THAT'S YOUR NUM3E. 14 THE COURT: LET'S NOT ARGUE 15 SACK AND FORTH. LET'S GO ON.. LET'S MOVE ALONG. 16 MR. RSNNEISEM: I HAVE NO 17 FURTHER QUESTIONS, JUDGE. 18 THE COURT: ANYTHING FURTHER? 19 MR. VAS5AL0TTI: JUST ONE 20 QUESTION. 21 BY mR. VASSALOTT I : Q. DOCTOR, I FORGOT TO ASK YOU, WHEN 23 YOU REFER TO THOSE LETTERS qF DOCTOR RCZANSKI, 24 DOCTOR DE PERSIA ANO DOCTOR GILPATRICK, 25 DOCTOR, IN YOUR POSITION *S A PHYSICIAN AND ASI-PR 0004450 cDIRECT - DR. EPSTEIN - MR. VA5S4LCTTI 217 TOXOCOLOG I ST STUDYING CAUSAL CONNECTIONS CAUSAL DELATIONS BETWEEN CHEMICAL S U 9 5 TA.nCES AND CANCER, WOULD YOU ORDINARILY RELY UPON THE REPORTS OF PHYSICIANS OF THE VICTIMS QP CANCER THAT YOU WERE STUDYING IN FORMING YOUR OPINION. MR. RENNEISEn: OWJECTJHm. I DIDN'T.HEAR ONE QUESTION ASKED AROUT twaT SUBJECT. THE COURT: I SUSTAIN THE OBJECTION, UNLESS YOU REPHRASE YOUR QUESTION. HR. VAS5AL0TTI: YOUR HONOR, I'M REFERRING BACK TO -- I AGREE WHOLEHEARTEDLY THAT MR. RENNEISE.N OID NOT BROACH THIS SUBJECT IN HIS RECROSS. THIS IS A MATTER THAT I OMITTED WHEN l -- WHEN I EXAMINED DOCTOR EPSTEIN tN REGARD TO THIS AND I l WANTED TO TIE UP A LOOSE END. THAT'S THE ONLY PURPOSE. THE COURT: ALL RIGHT. I'LL LET YOU DO IT. BY HR. VA5S-ALQTTI: Q. DOCTOR, IN YOUR CAPACITY OR POSITION AS m PHYSICIAN ENGAGED IN THE STUDY OF TOXICOLOGY AND CONSIDERING THE QUESTIONS OF ASI~pR 0004451  ' It. . # RE-t REDIRECT - DR. EPSTEIN - MR. VASSALOTTI 21 * THE CONNECT I ON BETWEEN CANCER COUSINS CHEMICALS AND DEVELOPMENT OF CANCER, WOULD 3 YOU ORDINARILY RELY UPON LETTERS WRITT EM ffROM 4 PHYSICIANS OF THE VICTIMS OF CANCER THAT YOU 5 WERE CONSIDERING WHEN SUCH PHYSICIANS report 6 TO YOU INFORMATION REGARDING THE 7 ADMINISTRATION OR PRESCRIPTION OF ANY 8 MEDICATIONS TO THE PAINT?. 9 MR. RENNEISEN: YOUR HONOR, 10 I'LL STIPULATE THE ANSWER IS YES, SO THE 11 DOCTOR DOESN'T HAVE TO ANSWER THE QUESTION. 12 THE COURT: -ALL RIGHT. 13 MR. VASSALOTTT: THANK YOU. 14 THE COURT: THANK YOU. 15 ANYTHING FURTHER NOW? 16 ALL RIGHT. DOCTOR, YOU MAY 17 STEP DOWN. 18 THE WITNESS: THANK YC'J, SIR. 19 THE COURT: WHY DON'T YOU JUST 20 STAY RIGHT WHERE YOU ARE FOR THE TIME BEING.' 21 THE COURT: LADIES A.NC 22 GENTLEMEN."GOOD TIME FOR STOP FOR THE 3 AY . 23 AS I HAVE CAUTIONED YOU 24 BEFORE AND WILL CONTINUE TO CAUTION YOU DURING THE COURSE OF THIS TRIAL, UNTIL THIS ASI-PR 00044S2 R REDIRECT DR . E ? S ts i :i VASSALOTTI 2 I'* 1 case is Submitted to yoj for oel irerat io\s, 2 YOU MUST NOT OISC'JSS this case with anyone OR 3 .< eMA IN WITHIN HEARING OF ANYONE DISCUSSING 4 IT. neither should you read any newspaper 5 ARTICLE, LISTEN TO ANY RADIO 5 R OAQCOAS T, NOR 6 VIEW ANY TELEVISION PROGRAM WHICH DISCUSSES 7 THIS CASE. 8 IF, HOWEVER, YOU SHOULD 9 3 EC ON* AWARE OF ANY SUCH STORY, ARTICLE OR 10 NEWS REPORT, YOU ARE TO REPORT THAT MATTER TO 11 ME IN MY CHAMBERS AT YOUR EARLIEST 12 OPPORTUNITY SO THAT WE MAY DISCUSS IT. 13 NEEDLESS TO SAY, SHOULD YOU HAVE SUCH 14 EXPOSURE,YOU SHOULD NOT MENTION THAT FACT TO 15 Any OF YOUR FELLOW JURORS. YOU ARE TO <EEP 16 AN OPEN MIND AND YOU MUST NOT DECIDE ANY 17 ISSUE IN THIS CASE UNTIL THE CASE IS 18 SUBMITTED TO YOU FOR YOUR DELIBERATIONS UNDER 19 THE INSTRUCTIONS OF THE COURT. 20 WE'LL STAND IN RECESS NOW 21 UNTIL TOMORROW MORNING AT :3C. AVE A 22 PLEASANT evening. 23 CRECESS FOR THE DAY.) 24 25 ASI-PR 0004453 -* ' t* 1 2 3 4 CERTIFICATION 5 I, STEPHEN J. OAMER, OFFICIAL 6 COURT REPORTER FOR THE UMITEO STATES 0ISTRIC7 7 COURT, FOR THE OiSTRICT Or .ME* JERSEY, 00 8 HERESY CERTIFY THAT THE FOREGOING MATTER IS A 9 TRUE AMO ACCURATE TRANSCRIPT OF MY 10 STENOGRAPHIC MOTES TAKEN AT THE Tl**E AMO 11 12 13 14 15 16 17 18 19 ! ^->2/ 2Q 21 22 23 24 25 ^ I "T f* ASI-PR 0004454