Document jyKnQJvm6wk3bkM45N60kw8RQ

RECEIVER f IN THE UNITED STATES DISTRICT COURT ZJ1982 FOR THE EASTERN DISTRICT OF PENNSYLVANIA^ RlJSKQ^ ( THOMAS J. MCCONNELL and DIANE : CXVIL ACTION MCCONNELL, his wife, individually: and on their own behalf and as : parents and natural guardians of : KRISTINE McCONNELLL, a minor, : r vs. j CIBA-GEIGY CORPORATION j and ! < ORXIN EXTERMINATING COMPANY, INC.*' NO.80-1692 < j! |! j Philadelphia, Pennsylvania December 9, 10, 1982 " ( i BEFORE: HON. ALFRED L. LUONGO, CHIEF JUDGE (And a Jury) TESTIMONY OF DR. SAMUEL EPSTEIN i I I APPEARANCES: STEPHEN R. BOLDEN, ESQ., ( WILLIAM W. SPALDING, ESQ., RICHARD C. FERRONI, ESQ., Attorneys for the Plaintiffs F. HASTINGS GRIFFIN, JR., ESQ., FRANK J. EISENHART, JR., ESQ., Attorneys for Ciba-Geigy EDWARD L. McCANDLESS, ESQ., Attorney for Orkin 20321001 REPORTED BY DAVID S. EHRLICH, CSR, RPR, CP, CM OFFICIAL COURT REPORTERS Room 2722 < U.S. Courthouse Philadelphia. Pa. 19106 1 OR. SAMUEL EPSTEIN, Sworn. 2 THE COURT REPORTER: State your full name 3 please. 4 THE WITNESS: Samuel Epstein, E-p-s-t-e-i^n 5 DIRECT EXAMINATION 6 BY MR. BOLDEN: 7 Q. What is your profession. Doctor? 8A 9 0- I am a toxicologist, pathologist, M.D.. Do you specialize in any areas of medicine? 10 A I specialize in the effects of toxic chemicals in 11 the environment, in air, water, food and the workplace. 12 Q. Would you give us your educational background. 13 A My educational background, as spelled out in 14 the curriculum which I gave you, is basically that of, 18 I qualified in physiology in London University, England, 16 I took a degree in medicine in 1950 in Gy's Hospital 17 in London University; in 1952 I took a degree in 18 tropical medicine and hygiene; in 1954 I took a degree 19 in pathology; in 1958 I took an advanced degree in 20 medicine; in 1963 I was awarded a Diplomate in public 21 health and medical laboratory microbiology; in 1971 I 22 was a Fellow of the World Society of Health, in England. 23 Ql By whom are you employed at the present time? 24 A University of Illinois Medical Center. 25 Q. And, in what position are you employed by them? z o o fs e o e 3 Dr. Epstein - Direct 1 A. I am Professor of Occupational and Environmental 2 Medicine. 3 Qi What does that mean? 4 A. That means basically that I have the responsibilities 5 in the areas of occupational health and environmental 6 health, with particular reference to considering, 7 discussing, researching problems of toxic chemicals, 8 either in the workplace or in the general environment, 9 and in consumer products too. 10 Q. How long have you been associated with the 11 University? 12 A. Since about 1976. 13 Q. Have you ever acted as a consultant to any federal 14 or state agencies in the areas in which you specialize? 15 A. Oh, very, very, very much so. 16 Ql Would you please list them for us, what you have 17 done. 18 A. First of all, I was a consultant -- I have been 19 a consultant to Congress for many years. From '69 20 onwards, I was a consultant to the Senate Committee on 21 Public Works, and assisted them in their analysis of 22 problems of adverse health effects from air pollution 23 and from water pollution, with particular reference to 24 toxic chemicals. 25 I have consulted to other congressional I 4 Dr. Epstein - Direct 1 committees on and off since then, roost recently to 2 Veterans' committees on problems of Vietnam Veterans 3 and Agent Orange. 4 Additionally, I have acted as an expert 5 witness in the Environmental Protection Agency in a 6 variety of its Cancellation-Suspension proceedings 7 against pesticides, with particular reference to aldrin, 8 dieldrin and chlordane, and heptachlor. 9 I have consulted to the Occupational 10 Safety and Health Administration extensively, and in 11 fact was in 1973, one, a member of a small committee 12 that set up the first guidelines for regulation of 13 occupational carcinogens, cancer-causing chemicals in 14 the workplace. IS Additionally, I have been a consultant 16 I have been a member of expert committees for the 17 Environmental Protection Agency, particularly the 18 Environmental Health Advisory Committee, and pesticide 19 subcommittees which had specific reference and expertise 20 in areas of pesticide regulation, and have helped to 21 develop guidelines for methods of testing for pesticides 22 and also for problems of pesticide exposures. 23 Additionally, I was the Chairman of the 24 Teratology Committee, the Teratological Panel -- that is 2S the birth defects panel -- of a major government 5 Dr. Epstein - Direct 1 commission in 1969. 2 Secretary Finch, in 1969, who was HEW's 3 Secretary, convened a panel, a commission, known as 4 the MRAK Commission, specifically to investigate problems S of pesticides and their relationship to environmental 6 health. And, I sat on the Carcinogen Committee, that 7 is the cancer -- problems of cancer from pesticides. 8 I was the Chairman of the Mutagenicity Committee -- that 9 is the committee on genetic effects, adverse genetic 10 effects of pesticides; and, Chairman of the Teratology 11 Panel or Committee. 12 Additionally, I have acted as consultant 13 to various state boards. I was consultant to the 14 Massachusetts Pesticide Board from 1970 to 1971; and IS additionally, I have consulted to Governor Brown in 16 California on various aspects of toxic chemicals, 17 including pesticides. 18 That is, I think, as far as I can recall, 19 those are the major areas of my involvement with 20 government in problems of pesticides. 21 0 Are you a member of any professional organization 22 which deal in your area? 09frZCO 23 A Yes. The professional organizations which I have 24 been involved in, on page 3 -- and, there are about 25 thirteen professional societies and organizations, 6 Dr. Epstein - Direct 1 ranging from New York Academy of Sciences* Society of 2 Occupational Environmental Health* which was the society 3 composed of government, management, academia and labor* 4 and I was the president of that society; 5 The American Association for the Advance 6 ment of Science; The Environmental Mutagen Society* 7 of which I was a co-founder and executive secretary; 8 The Society of Toxicology; largely an 9 industry oriented society of professional toxicologists, 10 although with membership from academia and government; 11 and this society gave me the Honors Achievement Award 12 in about 1970; 13 American Board of Microbiology, American 14 Association for Cancer Research, American Society for 16 Experimental Pathology, Air Pollution Control Administra 16 tion. Society of Protozoologists, Society for General 17 Microbiology, and Society for Pathology and Bacteriology 18 fli Doctor -- 19 THE COURT: Excuse me. 20 Do you wish to question on qualifications > 21 Had you concluded on qualifications? 22 MR. BOLDEN: I was going to get into some 23 of the articles he was involved in, if I might, your 24 Honor. 25 THE COURT: Sorry. Go ahead. 7 ( Dr. Epstein - Direct 1 BY MR. BOLDEN: 2& Have you published articles or texts in your field, ( 3 and specifically any in the area of teratology? 4 A. My publications amount to about 260 scientific 5 articles and about six or seven books, specifically 6 with relation to -- I wonder if I may break down your 7 question into more manageable elements. <8 I have about 30 publications on 9 pesticides, and as far as publications on reproductive 10 toxicity, including teratology, about 20 publications, < 11 including chapters in books on teratology, and also 12 publications in the official journal of teratologists t 13 known as, "Teratology." So, I have reasonable publica 14 tions in the area of reproductive toxicity. 15 Q. One final question. Have you ever donated any of ( 16 your services in an unpaid capacity in your area? 3 I 17 A. I would say I donate a very substantial amount of l 18 my time for what is called pro bono work, doing things 19 for nothing. to o ta s o z 20 For instance, hardly a week goes by in l 21 which I don't either respond to requests by radio, s 22 press, TV, for information either on a consulting ( 23 basis or making statements. I donate my expertise 24 freely to citizen groups, public interest groups all 25 over the country. ( 8 ( 1 Dr. Epstein - Direct I am the President of the Rachel Carson 2 Trust, for which I -- for several years I have never r 3 been paid a penny, and lucky ever to get travel expenses. 4 For instance, I am talking about media, 5 this week I have three TV -- two TV appearances, I think e 6 -- one of them on pesticides in fact, and so on and 7 so forth. c8 Additionally, I have donated my services 9 pro bono for the last two years or so to litigation on 10 behalf of Vietnam Veterans, the Agent Orange Litigation. f 11 So, I spend a great.deal of time on 12 a pro bono basis. 13 MR. BOLDEN: Your Honor, that would 14 conclude the questioning on qualifications. MMM ?(. ..' (iMl - ram vat 8 0 0 1 ''G O S 15 MR. GRIFFIN: I do have a few questions, < 16 your Honor. 17 THE COURT: You may. 18 VOIR DIRE EXAMINATION 19 BY MR. GRIFFIN: 20 ft Bottom line. Doctor, are you attempting in this 21 case to qualify yourself as an expert teratologist? 22 A No. 23 ( MR. GRIFFIN: In that case, your Honor, 24 I have no further questions. 25 4 MR. McCANDLESS: I have one or two. 9 Dr. Epstein - Voir Dire 1 VOIR DIRE EXAMINATION 2 BY MR. McCANDLESS: 3 Q. Doctor, in what states are you licensed to practice 4 medicine? 5A None. 6 Q. You have an M.D. degree,right? 7A I do. 8 ft You talkedabout a number of appointments you have 9 had in consulting work. I haven't heard any date since 10 1971. Are you currently serving in any governmental 11 consulting capacity now? 12 A No. The last governmental work I did was, I think 13 I stopped in 1979. That was the Environmental Protectio 14 Agency, the Environmental Advisory Committee. Since IS then I have also been doing some government work on 16 a state level, particularly in California. 17 Ql Just to make it clear, is your appearance here 18 today one of your pro bono activities? 19 A No. 20 Qi This you will be paid for? 21 A 22 Q. 23 24 25 Certainly. Okay. MR. McCANDLESS: I have nothing else. THE COURT: You may proceed. MR. GRIFFIN: Your Honor, I object to IS O iS D D ) 18 Dr. Epstein - Direct f 1 consider yourself an expert in any aspect of that 2 field? r 3 THE WITNESS: Yes, sir. In the 4 evaluation of teratological data. e5 If the Court permits, I would like to e clarify my previous answer to Mr. Griffin, being, no. 7 When I was asked if I was a professional < 8 teratologist, that implied did I constantly -- 9 THE COURT: Excuse me. Dr. Epstein. c 10 I don't recall hearing such a question. 11 THE WITNESS: I beg your pardon, sir. 12 I thought I was asked a question if I was professional 13 or expert. 14 THE COURT: Mr. Ehrlich, would you go M il N# IS back to the question posed by Mr. Griffin and repeat C 16 it. 17 THE COURT REPORTER: "Question: Bottom 18 line, Doctor, are you attempting in this case 19 to qualify yourself as an expert teratologist? *#NM. m.h 20 "Answer: No." HIM# t f * 21 THE WITNESS: If the Court permits, I iu tc c a 22 would like to qualify that answer by saying I am not i 23 an expert teratologist in the sense that I perform 24 experimental teratology on a routine basis. However, 25 I am expert in the area of evaluation of teratological 1  19 Dr. Epstein - Direct f 1 data in general, and in particular with problems of 2 risks to humans from exposure to teratogens in the f 3 environment. 4 Apart from my publications in the area/ t 5 this is attested by my various governmental appointments 6 in areas including those in teratology, such as Chairmar 7 of Important Blue Ribbon Commissions, which dealt with c 8 the -- the panel which dealt with teratological effects 9 of pesticides. 10 c THE COURT: Do you wish to cross-examine n further? 12 MR. GRIFFIN: Yes, sir. 13 VOIR DIRE EXAMINATION(Continued) 14 BY MR. GRIFFIN: IS Ql If I hear what you are saying, you are saying c 16 although you are not an expert teratologist, you are * m m s 17 going to take some literature and you are going to i 18 look at it and tell us what you think the literature -? 19 means as a teratologist would view it, is that fair? w S 20 A. I repeat what I said, that I have expertise in the * 21 evaluation of teratological data, but I do not practice ss 22 teratology on a routine basis. i 23 ft The same as any other doctor, you can read a 24 medical report on teratology and interpret it. 25 A No, sir, not the same as any other doctor in the 1 STOt'^ 6 0 20 Dr. Epstein - Voir Dire r 1 sense that I am a person who has published extensively 2 in the areas of toxic chemicals in the environment, I c 3 have advised government committees on this, I have set 4 up standards for government, and have very substantial 5 expertise in the evaluation of risks to pregnant women c 6 from exposure to toxic chemicals in the environment, 7 ft Let me ask you this. Doctor: In the chemical 8 exposure cases in California Superior Court, in 9 San Francisco, where you gave a deposition in September 10 of 1982, did you testify, in answer to a question as C 11 to your qualifications: 12 "First of all, the literature on this ( 13 is pretty modest in comparison with the over 14 whelming literature on teratology, and before NHH ^ \. IIIUI. U. 1^1 fIM 15 answering it I should also point out that I don't 1 16 hold myself out as an expert in. teratology, so 17 the answers I will give you will be -- I won't 18 say poorly informed, but not expert, not that of 19 a professional." 20 A. Certainly. As I repeat again, I am not a 21 professional teratologist in the sense that I do 20924019 22 experimental teratology on a routine basis. I have 23 made that clear, I think. < 24 ft I think we need to define teratology. What is 25 the science of teratology? 1 21 Dr. Epstein Voir Dire ( 1 A. Well, if we accept it as a science, teratology is 2 the study of birth defects caused by exposure to agents f 3 in the environment, or in some instances simply just 4 the study of birth defects with no known exposure. 5 Qi And you, yourself, I gather, when you say you are t 6 not expert in the field, means you have never conducted 7 such studies. C 8 A. No, sir, that is not what I said. What I said 9 is, I don't conduct such studies on a routine basis. 10 I have conducted such studies. 11 In fact, let me be very specific. I 12 have specifically studied the fetotoxic and teratogenic ( 13 effects of N nitroso compounds in guinea pigs, and I 14 have several publications in this area. But, I don't 15 do this on a routine basis. C IS ft And, you do not consider yourself an expert * t 17 teratologist, you have said so over and over again, * ( 18 haven't you? a 19 A With due respect, the possibility exists that we m 9 9 +m 20 may be indulging in a semantic argument. 1 21 t When I said I did not consider myself 9mM 22 an expert teratologist, that definition relates to the c 23 routine practice of experimental or clinical teratology. 24 That answer to that is no. 25 i With respect to the evaluation of human 20924020 22 Dr. Epstein - Voir Dire 1 risks from exposure to teratogenic agents, and with 2 respect to the evaluation of experimental data, I do 3 most certainly consider myself an expert, and in fact 4 I am so considered by a wide-range of government and 5 non-government bodies. 6 Cl Now, as far as this case is concerned, what you 7 propose to do is simply review literature and draw 8 some conslusions from it, correct? 9 A. No, that is not entirely the case. 10 Cl What is entirely the case? 11 A. I propose to produce to the Court statements from 12 the literature from which the Court can draw its own 13 inferences * 14 In addition, I will be drawing inference: 15 from those data which may or may not be consistent with 16 the statements in the literature. In other words, I 17 will be -- 18 Cl 19 A. Thank you. Excuse me, sir. 20 Cl Excuse me. 21 A. In other words I will be confining myself to my 22 area of expertise, which is the evaluation of data and 23 also the evaluation of human risk, which is my 24 professional area. 25 Cl But, your professional area is not that of a 20924021  23 Dr. Epstein - Voir Dire c 1 teratologist, and what we are - concerned with in this 2 case is the evaluation of teratological data, aren't * 3 we? 4 A. You are forcing me to be repetitive, sir. I am 5 experiment professional teratologist in the sense that C 6 I do not perform experimental teratology on a routine 7 basis. ' 8 Ql That is -- 9 A. But, as far as the evaluation of data is concerned, 10 I am indeed expert in this area. C 11 Ql And, in that area, you say you are not -- poorly 12 informed, but not expert -- you don't have the views ( 13 of a -- your views are not that of a professional. 14 A Precisely. I am not an experimental teratologist. 15 Ql How, Doctor, if you are not expert in that field, C 16 if you don't keep yourself up, as it were, with every $ m 17 thing that goes on in the field, can you properly S C 18 evaluate literature in the field? That is what you are i 19 doing. HIUI, .l. ? 20 A Because, my expertise is in the area of evaluation MUM* *1 21 of toxicological data. 3s 2 22 Toxicology is the study of the toxic or 1 23 adverse effects of chemicals, which includes carcino 24 genesis, cancer; mutagenesis; teratogenesis, birth 25 defects; acute toxicity; subacute toxicity; chronic i l l 20924022 24 Dr. Epstein - Voir Dire 1 toxicity. It is a wide-range'of adverse effects in 2 which I have substantial expertise. * Now, it is humanly impossible to be 4 performing all of these individual subareas of . toxicology on a routine basis. My profession is in 6 the evaluation of data on toxic effect, be it terato 7 genic or carcinogenic, together with a formulation of 8 opinions as to human risk. 9 MR. GRIFFIN: Well, your Honor, I have 10 no further questions. < 11 THE COURT: I will permit the witness 12 to testify, and the jury of course will accept the < 13 testimony from this witness in light of the answers 14 that he has given in which has expressed the reservatiors 15 that the jury will evaluate. ( 16 You may present your case, Mr. Bolden. 17 DIRECT EXAMINATION(Continued) * BY MR. BOLDEN: i m ft Doctor, at my request, did you conduct an investi I 20 gation into the pesticide Diazinon for the purpose of determining its teratogenicity? 9 z 22 A I did, sir. . < i 23 Cl And, as a result of that investigation did you 24 arrive at an opinion on its teratogenic properties or h 25 potential? ^ 1 C S jiS G O Z 25 Dr. Epstein - Direct c 1 A. Yes, sir. 2 Q. Would you please state what your conclusion is. C 3 A. My conclusion is that there is a substantial 4 probability that Diazinon is teratogenic and represents 5 a teratogenic hazard to humans exposed to it. C 6 CL Would you please state how you arrived at your 7 conclusion and what underlying data you reviewed for 8 the purpose of forming your conclusion. 9 A. With the permission of the Court, I would like to 10 use one or two simple charts to explain the basis for 11 my opinion. 12 THE COURT: I haven't any idea what you 13 are going to do here, Mr. Bolden. I can't rule on 14 the admissibility of a chart without an idea of what 15 it is all about. ( 16 THE WITNESS: May I respond, or do you 9K a s 17 wish Mr. Bolden to respond to that? I 18 THE COURT: I think Mr. Bolden should a 19 respond to that initially. u m 20 MR. BOLDEN: Your Honor, as I understand < 3 21 it from talking to Dr. Epstein last night and this aaa 22 morning, he has prepared certain charts, actually three ( 23 charts, one of which summarizes the findings from 24 various studies of various kinds of animals as to whetht r 25 they were negative or positive for showing teratogenic t 20924021 * 26 Dr. Epstein - Direct 1 effects, and has listed them as summarized chart, 2 and another -- r3 THE COURT: Excuse me. Let's just 4 clarify one thing. Are these Dr. Epstein's studies? 5 MR. BOLDEN: No. These are studies 6 from other -- 7 THE COURT: Are these from certain 8 publications? 9 MR. BOLDEN: Certain publications. 10 THE COURT: And those publications will i 11 be here to support those. 12 THE WITNESS: Yes, sir. c 13 MR. BOLDEN: Yes, sir. 14 Do you have all of them here with you? 15 ( 16 THE WITNESS: I think so. THE COURT: All right. We will proceed. 17 We will deal with them on an individual basis. 18 A This first chart, which I hope is visible is 19 listed as "Quotations Prom Literature on Teratogenicity 20 of Diazinon," and the chart contains two columns. Mi NNI ^11 T 1MIIII m m 21 The column on the left is the author, 22 and the date of the statement. And on the right the 1 23 quotation is actually using the author's words. Wt O 24 If I may, I will proceed. J\) 25 t MR. GRIFFIN: If your Honor please, I O t-rt 27 Dr. Epstein - Direct t 1 object to this procedure. This seems to me, is nothing 2 more than picking words out of some study that is done f 3 somewhere and trying to give those words probative 4 force, and they obviously can't have that; And, if 5 there is an exception to the Hearsay Rule, I think your 6 Honor should look at this whole picture to figure out 7 whether there is. It certainly has to be introduction C 8 of an article, not words from it, and that this is just 9 an attempt to build an argument based on what is in 10 the literature, not an expose of the actual probative 11 effect of what it may be. 12 THE COURT: I will give you the full 13 opportunity in your cross-examination to probe all of 14 that. We will at this time proceed in this fashion. 15 THE WITNESS: Thank you. 16 A (Continuing) The first article is by Khera, in t * 17 1968. Dr. Khera is a member of the Canadian Food and I 18 Drug Administration, and Dr. Khera states that Diazinon 19 induced -- and, I quote, "congenital foot deformities," 4 u tum 20 in duck and chick eggs. Kumsk 21 The next article by Kimbrough and Gaines 22 in 1968, Kimbrough and Gaines were government scientists l co#23 working at the Center for Disease Control in Atlanta, 24 states, and I quote: "Diazinon produced some mal 25 formations ." i 28 f 1 Dr. Epstein - Direct "The spontaneous incidence of malformatiors 2 -- well, no. That is fine. "Diazinon produced some 3 malformations." * The next is Green, 1969. "Diazinon 20921027 M> 00 W produced teratogenic activity in all chicks." 6 The next is Earle, 1973, United States 7 Food and Drug Administration. "Teratogenic abnormalities have been observed in dogs given Diazinon. Teratogenic 9 abnormalities have been seen in sows given Diazinon." 10 That is pigs, miniature pigs. 4 11 Nishimura, a Japanese scientist, in 12 1973, "The following chemicals were proved to have a M teratogenic effect: Diazinon." 14 NIOSH, National Institute for Occupational 15 Safety and Health, 1978: "Based on the available C 16 evidence, Diazinon can be considered possibly teratogenic * *: 17 and should be handled with caution by women of child i bearing age." i a* Sax, 1979, a standard textbook on I 20 toxic chemicals: "Diazinon is 'an experimental 1 529 21 teratogen.'" 22 NI0SH, National Institute for Occupation 1 i 23 Safety and Health, RTECS, which stands for Registry of 24 Toxic Effects of Chemical Substances, in 1977, in 1978, 25 in 1979 and in 1980, states that Diazinon is a 1 M . ttftl MUM* Ik . 29 Dr. Epstein Direct C t teratogen. 2 That, sir, is the first chart I wish C 3 to draw to the attention of the Court. 4 The next chart relates to the actual C 5 summary of the experimental findings on teratogencity 6 of Diazinon. 7 The chart is headed, "Teratogenicity < 8 of Diazinon." And, 1 have attempted here to summarize 9 all the literature in which I am familiar, all the 10 studies done on Diazinon from the point of view of its 11 birth defect potential. 12 And, there are three columns here. The < 13 column on the extreme left is the species, the animal 14 in which it was tested. The middle column is on the 15 author, including the date, and the right column is 16 on the results. 17 I would like to stress at this stage 18 that this chart represents my most recent evaluation 19 of the literature. 20 I had in fact considered the literature 21 prior to a deposition last year, but since then I have 22 have the opportunity of going into the literature more 23 1 thoroughly, evaluating studies which I had evaluated 24 before, and also evaluating all evidence which has 25 become available to me. And, this is my evaluation of 1 N M I I C l. M M W I. .#. H IM r N i H I 30924028 30 Dr. Epstein - Direct the data, and in many instances such evaluation actually reflects the author's own statements. The first -- MR. GRIFFIN: Excuse me, your Honor, I don't like to interrupt, but here again- I have an objection based on what the Doctor has now said. Your Honor ruled in an Order that we were to be able to take this Doctor's deposition since he was held out as an expert. And, at the time of the deposition he should be fully informed to; testify about everything that he was going to testify to in Court, that we could have advance notice. We took his deposition and got such advance notice. Already he has come up with on the prior chart there, with studies for books that I haven't had a chance to even look at. And now he says in his testimony, I have since my deposition, I have gone and done other work. And -- THE COURT: I will -- MR. GRIFFIN: Your Honor, I think he shouldn't be permitted to do it. THE COURT: I will have to limit him to what he disclosed at the time of the deposition, Mr. Bolden. He will have to -- whatever way he has to tailor his testimony, he has to go back to what it was 31 c Dr. Epstein - Direct 1 at the time of the deposition! 2 We had a serious problem in this case * a and we tried to resolve it as best we could by the * ruling that was made. He will have to conform to that r s ruling. 6 BY MR. BOLDEN: 7 Qi Do you understand that. Dr. Epstein? 8 A. Am I permitted to make a comment, sir? 9 THE COURT: No. I think the best you 10 can do is give us the testimony that you gave at the C 11 time of deposition, or that which is consistent with 12 what you gave at the time of deposition. t 13 *< If what you have learned since makes 14 a substantial change in your opinions or testimony. 15 you will simply have to ignore it. 1 18 THE WITNESS: All right, sir. i THE COURT: We must conduct litigation l 18 by certain rules. Doctor, and the rule that I made i i9 earlier was that whatever was disclosed at deposition a * 20 is what would be the subject matter disclosed at trial. i A At the time of -- with further reference to this 22 chart, at the time of my deposition I stated specifically 20924030 t-a i that I had not yet completed my evaluation of the 24 literature and, therefore, the statements which I made 25 at my deposition reflect such incomplete evaluation. 1 32 < 1 Dr. Epstein - Direct To be specific, I stated, "I don't think 2 I have really completed the work yet." Therefore, C 3 statements at my deposition reflect such incomplete 4 evaluation, but I will proceed on that basis. 5 * MR. McCANDLESS: Your Honor, I object 6 to the voluntary statement of the witness in response 7 to no question, and apparently in contempt of your ordei ( 8 in directions to him to try to limit himself to whatevei 9 it was -- 10 < THE COURT: No. I think he was explainirg 11 that at the time of deposition he made the statement that 12 he was giving testimony based on incomplete data, and < 13 I have simply ruled that whatever it was, that is what 14 he will be limited to. 15 MR. GRIFFIN: Your Honor, I don't think c 16 your Honor perhaps has actually looked at your Order. 3 * *: 17 Your Order stated that he is to be fully informed when I 18 his deposition is taken. 19 THE COURT: And, all that I am ruling m m 20 now is that fully informed means that he will now 34 21 confine himself to what he had at the time of the tt 22 deposition. 23 1 The jury will ignore everything else. 24 We do operate according to rules here. 25 A It is clear from the literature that a variety of 4 20324031 . 33 f Dr. Epstein - Direct 1 studies have been done -- 2 '3 MR. GRIFFIN: Excuse me. If your Honor please, could I get the 4 Doctor to strike from the chart the post-deposition . 5 literature he is referring to? * 8 THE COURT: Was all of that that you 7 testified to earlier post-deposition? < t8 THE WITNESS: Some of these data, sir. 9 are based on material which I hadn't examined at the 10 time, but which I have examined, but which are in the < 11 published literature. 12 THE COURT: I will have to sustain the f 13 objection. We will have to strike the references to W 14 literature that was not referred to at the time of 15 deposition. t 16 s That deposition was taken when? 5 17 % MR. BOLDEN: THE WITNESS: August of 1981. w 00 i I f 21 mm % 22 THE COURT: All right. Not '81. THE WITNESS: Yes, sir -- MR. BOLDEN: August 26 of '81. THE WITNESS: Yes, sir, of '81. 23 1 THE COURT: Nothing further was done 24 before trial? 25 t MR. BOLDEN: Your Honor, I might add 20924032 34 Dr. Epstein - Direct f 1 that -- of course -- maybe I should do it at side bar. 2 r THE COURT: Come to side bar. (Side bar discussion on the record. as follows:) f* THE COURT: How can you permit the case 6 to come to trial without updating the expert material? 7 ( * 8-- MR. BOLDEN: Your Honor, the literature 9 THE COURT: I was surprised when he said 10 August '81. 1 thought he meant '82. 11 MR. BOLDEN: All the literature we 12 are talking about is literature which came from Ciba- < 13 Geigy's files which was made -- if I am not mistaken -- 14 all of the literature are their published works, all of 15 it was in Ciba-Geigy's files. t 16 We may have had some of it ourselves, 9 8 17 but it was all turned over to us as part of the studies ck 18 -- not studies, part of the documents which Ciba-Geigy 2 1 produced. i MR. EISENHART: All that was made avail \ 21 able to them well prior to the deposition. a 22 MR. SPALDING: That is not true. 20924033 i 23 MR. BOLDEN: That particular statement 24 is not true. 25 1 MR. SPALDING: Your Honor, you will 35 Dr. Epstein'- Direct/Side Bar remember the controversy arising over my trip down to Greensboro when they refused to produce the document!; c 39 1 Dr. Epstein - Direct/Side Bar MR. GRIFFIN: My objection -- it seems 2 to me the whole purpose of this is to avoid that kind c 3 of thing for the poor attorney who is trying to get 4 himself ready to try a case. We are dealing in the # 5 field we know not ourselves. All we can do is take 6 advice from others, and if we don't have the time to 7 get the advice ahead of time, we are unduly strapped. <8 9 THE COURT: Yes, I understand. MR. BOLDEN: Your Honor, in his direct 10 examination will he be permitted to correct an error < 11 he made? Now, this is not a question of supplementing 12 new literature. It is a question of clearing up an c - 13 area -- 14 MR. GRIFFIN: He is just anticipating 15 cross-examination. < 16 THE COURT: Well, I think he has a 17 right to. 1 18 18 MR. GRIFFIN: He can if he wants to. THE COURT: Yes, and I think he should. tiaaai. 20 MR. EISENHART: He was reading this rm n SG0t'~C0 21 chart backwards at deposition, Mr. Bolden. 22 i (End of side bar discussion.) t: V 23 THE COURT: Members of the jury, we 24 have had a long discussion here at side bar, and it 25 requires Mr. Bolden to make a statement out of your a joj axqBXTBA* apam sx qxpqo xaqqouv) co c * ITS r* rc*o 'uxpBp no/i axqnojq upa 1 3X 'uouxzpxa 30 qxoxua6oqp:raq cl aqq 30 Axpuiwhs aqq oq qopq amoo oq `aon *C6T 'si-iea pup .'6961 T uaa.JD *8961 'sauxps pup qfenojquixji *8961 'airaqa 'auo qsxx3 aqq apnxaux qsxx sfqq ux squamxxadxa aqq pxp oqM axdoad aq noX 3(upqi Y (ssauqxw aqq X03 axqPXTAB apaux sx qxpqo aqj.) paqaxdmoo qsnf aAPq 1 qoxq/* auo snoiAaid aqq 'Xpui i 3X 'qxpqo snoxAaxd aqq oq umai am qax -- saoupqsux 2x103 uj squamxxadxa aqq paqonpuoo oqM axdoad xnqop aqq 'os *squamxxadxa aqq paqonpuoo 3APq oqM axdoad x^qoa UX023 auioo squanaqpqs asaqq 30 moj sqoa3ap qqxxq saonpoxd 'oxua6oqpxaq sx uouxzpxq qpqq 8961 oq qopq fiuxob amqeisqn aqq ux squamaqpqs qqxa qspax qp sisa axaqj uouxzpxa 30 Aqxoxuaboqpxaq aqq uo axnqpxaqxx aqq mox3 suoxqpqonb aqq axaq* qjpqo snoxAaxd aqq azxxpuiums qsnC am qax *uxuoxqsanb aqq oq asuodsax xaqqxnj ux y (ssauqxA aqq pup uapxog xh uaaAqaq uoxssnosxp pxooax-aqq-330) xpq apxs qp appm 1 buxxnx aqq oq mxo3uoo jSpui aq qpqq xapxo ux ssauqtA sxq oq buxxpaq qoaxja - uxaqsdg *xa Ofr sz tz ez zz LZ oz 61 81 41 91 SI H ei zi u 01 6 8 4 9 5 t 8 Z l > > m mmm m< ) s > > > 1 * i i 41 Dr. Epstein - Direct r i the witness.) 2 It is clear that there have been some r 3 where in the region of 13 studies on the teratogenicity 4 of Diazinon. These studies have involved eight species, 5 And, I think it is necessary to emphasize to the Court 6 that these studies have not produced uniform results. 7 They are a mixed bag. c8 In some of the experiments Diazinon 9 was shown to be teratogenic and in some of the experi 10 ments it was shown not to be teratogenic. Some of the m %. 11 experiments are better than others, some of the experi 12 ments are worse than others. In other words, it is c 13 difficult to place equal weight on. all the experiments * 14 whether positive or negative. 16 But, it is necessary for me to explain c 16 the difference between positive and negative data from k s 17 a toxicological standpoint. s 18 1 In toxicology, in the study of -- a 19 MR. GRIFFIN: Your Honor, what question a a a 20 is being answered now? \ a 21 aaa 22 THE WITNESS: I am -- THE COURT: I think he is outlining and 0924040 23 summarizing certain information from studies. He may ( 24 proceed. 25 < THE WITNESS: Thank you, sir. < 42 Dr. Epstein - Direct 1 A. In the chart which you see in front of you, you 2 will see some pluses and some minues in the extreme t 3 right-hand column. And, before getting into any 4 specifics, I would like to explain the difference, the t 5 difference in toxicological significance between a 6 positive study and a negative study in toxicology. 7 In general, a positive study -- finding 8 a result in a toxicological test, be it study of birth 9 defects or cancer, supersedes a negative study. In 10 other words, if you have a positive finding of an C 11 adverse effect in any one system, this result is much 12 more important than a study in which you failed to c 13 find an effect. And the reason for this is very very 14 clearcut. The reason for this is, toxicology is a <. N.i. ! . IN K M Tt-OtCGOZ 15 very insensitive subject. It is a very very insensitive 4 16 discipline and it is terribly important to get this 17 point across before we get into the specifics of any 18 positive and negative studies. And, with the permission 19 of the Court, I would like to explain why toxicology 20 is an insensitive subject. 21 Let us say we introduce into the 22 environment an agent which induces 1 in 10,000 cancers, ( 23 or 1 or 10,000 birth defects, okay? Therefore, in the 24 United States alone, that one agent would be responsible 25 for 20,000, or 20,000 cancers a year, which would be 43 Dr. Epstein - Direct 1 H a national calamity. 2 Now, what are our chances of picking up 3 such an effect in experimental systems? 4 Now, let us assume that the sensitivity 5 of a rat, or mouse, or guinea pig to a particular agent 6 is the same as that of a human being. Therefore, if 7 you were to test in animals at the same levels as you 8 test in humans, you need 10,000 rats, or 10,000 mice 9 in an experiment to get one adverse effect, one cancer 10 or what have you, and for statistical significance you 11 may need 20,000 rats or 20,000 mice. f2 In an attempt to reduce this insensitivity 13 of animal tests compared to large human populations, 14 we tend in animal tests to test at levels higher than 15 those of human exposure. C 18 But, the fact is this: When you are th 3 17 dealing in an animal test with 20 or 30 or 10 animals, 18 this is very insensitive, and your chances of picking 19 up an agent which induces birth defects or cancer, 20 in one in a thousand, is virtually nil; in one in a i 21 hundred can be virtually nil. Therefore, you have got a r 22 to understand, toxicology per se is a grossly insensiti^ 23 subject. It is grossly insensitive because we test 24 for very small numbers of animals compared to massive 25 human populations at presumptive risk. And, this is an 0324042 44 Dr. Epstein Direct axium in teratology, and in toxicology in general, that a positive result, unless in a study of course that has controls, and doesn't -- and in which other advers effects have not been introduced, that a positive result is very much more important than a negative result. & Doctor, can I stop you in your explanation to ask you one question with respect to that. Is there anything from recent history of the last 30 years that demontrates a point that a negative study is superseded by a positive study? A. Let me tell you about thalidomide. Q. Is the answer yes? A. The answer is yes. And, thalidomide is a most excellent example of this. Rats and mice are somewhere in the region -- mice are somewhere about 700 times more resistent to thalidomide than humans -- MR. GRIFFIN: Do I have to try a thalidomide case? I have enough trouble with the Diazinon case. MR. BOLDEN: Your Honor, he doesn't have to try a thalidomide case, but I believe this witness is entitled to explain why a positive and a negative study have different implications. And, if he has to do it by illustration, I believe that is an 45 Dr. Epstein - Direct appropriate way of receiving it. THE COURT: All right. But, he should be careful not to intrude in an area where an objection has been made and until it has been clarified. THE WITNESS: Yes, sir. THE COURT: I will permit it, but I will * caution Dr. Epstein once, and I hope I won't have to caution him again: When you hear an objection. Doctor, be very circumspect and very careful about what you say until we get a clear ruling. You may proceed along that line. A My point about thalidomide is not wishing to get into any aspect of this, but merely to talk about problems of insensitivity of animal tests. There are many occasions in which you can demonstrate that animal tests are very very insensi tive and, therefore, when you get a positive in an animal test, this is a lighted beacon, and ignore this at the peril of society. Now, to come back to the -- Qi Just one second. Doctor. With respect to that statement, as it related to the experience that actually t: happened in the thalidomide situation, how does that relate to the positive-negative aspect of what you were talking about? What was demonstrated there? O 46 Dr. Epstein - Direct f 1A Well, to the best of my recollection, thalidomide 2 is -- the teratogenic effects of thalidomide in mice f 3 are 700 -- mice are 700 times more resistent. Therefor^ 4 testing -- 700 times more resistent to thalidomide 5 than humans. And, therefore, one could easily have e 6 missed the teratogenic effects of thalidomide using 7 rodent species. And, therefore, this is the principle < 8 in toxicology in general, not only in teratology, but f im iw 9 in carcinogenesis, and the full area of toxic chemicals 10 in the environment, the insensitivity -- < 11 THE COURT: Just a moment. Dr. Epstein. 12 You offered thalidomide as an example. Were tests c 13 conducted and did it in fact fail to reveal something? 14 Is that what you are trying to get across? 15 THE WITNESS: Essentially, the only c 16 point I am making is that you have major variations 17 in sensitivity from animal species to humans -- 18 THE COURT: No. Would you just answer 19 the question. Were some tests conducted? 20 THE WITNESS: Yes, sir. 21 THE COURT: Well, this is the only 22 significance, it seems to me, that your earlier comment 1 23 could have. And, if you would address yourself to that 24 BY MR. BOLDEN: 25 ft Were there differences in animal speci] that were n u ll A , im n , 20324045 47 Dr. Epstein - Direct tested with respect to thalidomide that produced different results? A. Yes, there are. ft Explain that. A But I must stress we are dealing with two factors here, both of which I would just like to segregate because there may be ambiguity. One is the insensitivity of animal tests in general. Animal tests, irrespective of whether they are mice, rats, guinae pigs, monkeys, what have you, are insensitive because you only test a very small number of animals compared to very large human popula tion. That is one problem. The second problem is differences in sensitivity from species to species. Some species are much more sensitive than others and others are much less sensitive than others, and you don't have any way in advance of knowing whether humans are more sensitive or less sensitive. Humans could be very much more sensitive to a particular cancer-causing agent, or birth defect cancer-causing agent. And, the importance of thalidomide lies in relation to this -- that thalidomide -- humans IM were much more sensitive to thalidomide than animal tests, particularly mouse and rat tests. 48 Dr. Epstein - Direct 1 Now, to get back to -- I must apologize 2 for that long explanatory note. But, to get back to f 3 the summary of teratogenicity of Diazinon, here you 4 see about 13 studies done on teratogenicity of Diazinon. 5 mixed results: some positive, some negative. sr. e The previous chart had statements from 7 four of the people who conducted these studies who f 8 clearly concluded that they are -- they were positive. 9 Now, my interpretation of the data, c 10 therefore, is weighed in the favor of -- there is a 11 frank bias in the direction of positive data. I am 12 biased in the direction of positive results for the ff 13 reasons which I have explained. That is number one 14 bias. 15 4 The second is that I don't believe that 18 any one of these studies -- that -- I am not proposing 17 that the inferences that I draw on teratogenicity of 18 Diazinon rests exclusively on any one of these positive 19 studies. They rest on the aggregate of the data. 20 In toxicology, you examine individual 21 studies and you draw inferences from them, whether they 22 be positive or negative, but you also examine all the 1 23 positive studies together an you look at all the nega 24 tive studies together. And, it is possible that in 25 some instances you may say, well, I'm not terribly ( rH m I I I H M . I.J .^ N IM H O IZ C O Z l 49 Dr. Epstein - Direct t happy about that one positive- study alone, but that one 2 positive study together with other positive studies 3 creates a more persuasive position, and that is 4 basically my eeling in the matter. 5 I subscribe to the position in the 6 literature that Diazinon is teratogenic, and the basis 7 for this rests on some of these studies here. 8 Now, I should point out, and I gather 9 that I have the Court's permission to explain this, 10 that there are some discrepancies between my listings 11 of positive results here and negative results here, 12 and those at the time of my deposition, because, as I 13 indicated before, I had not completed my evaluation of 14 the literature. And, I will be very specific as to IS these. 16 For instance, the first three studies -- 17 the first two studies I call positive here, and at the 18 time of my deposition I said they were negative. That 19 is because I did not have access to a paper which I 20 have in court which states -- the paper -- another 21 paper by the authors which states that the duck egg 22 and the chick egg study were both positive, and I did 23 not have that paper with me at the time. And, there 24 fore -- 25 MR. GRIFFIN: It seems to me this is e to tte o t 50 Dr. Epstein - Direct 1 precisely just the opposite what your Honor ruled. 2 THE COURT: No, no. We said that there t 3 would be a clarification of a mistake. Now, is this -- 4 MR. GRIFFIN: This is not it, sir. 5 He is simply using articles that you told him not to # 6 use and he is now saying, now look, I am only going to 7 use three. Here are the three results. Now, one of 8 those he didn't have before. Here are the three result!; 9 and I want you all to know I am taking those out, but 10 he is just repeating them and left them on the chart. 11 I don't know these cases that he is 12 bringing up now. I never heard of them before. C 13 THE COURT: I am not sure I understand 14 exactly what it is everyone is saying here. 18 Members of the jury, I ruled at side bar c 16 it was brought to my attention that Dr. Epstein had I * *s 17 made a mistake at the time of his deposition,, and that 18 he has since learned that it was a mistake, and I did i 19 allow him, or gave permission that he could clarify that m999m i 20 he did in fact make a mistake, even though it was based l 3 21 upon information that he obtained later. % 22 Now, let's not go beyond that. And, 23 Dr. Epstein, don't you go beyond that. 24 BY MR. BOLDEN: 25 ft Dr. Epstein, specifically as it relates to the i 20324049 51 Dr. Epstein - Direct mistake, confine yourself to -the Ciba in-house study. A. I beg your pardon. I was under the impression I was allowed to correct mistakes. & Not at at this point. Just the mistake -- that specific mistake. A. I understand. I understand. Therefore, as far as the first two studies are concerned, the authors themselves, the Khera and Lyons, and Green, all have' stated that those results are positive. I will not be discussing those further at the moment. MR. GRIFFIN: Are those ones you did not tell me about in the deposition? THE WITNESS: In the previous chart, I listed Khera and Green as stating that they induced congenital abnormalities. I am not discussing this now, I had this up on the previous chart. On the previous chart I had a quote from Khera that it induced congenital deformities. I have already discussed that and I have already discussed Green's statement that Diazinon was teratogenic and, therefore, I was referring just then exclusively to statements in the literature in the previous chart. MR. GRIFFIN: I just wanted to make sure that we were doing that. Doctor. THE WITNESS: Oh, yes. 0924050 52 f 1 Dr. Epstein - Direct MR. GRIFFIN: We are not dealing with 2 any literature subsequent to your deposition, right, 3 and you are not calling any such literature to the 4 attention of the jury, right? 5 C THE WITNESS: In the previous chart I 6 have made statements in the literature on the 7 teratogenicity of the Diazinon. I am now discussing c 8 my analysis of the experimental data which is different 9 from making quotations from the literature. 10 < THE COURT: Did you understand that my 11 ruling comprehended the chart as well? 12 THE WITNESS: This chart as well, I 13 understand -that, sir. 14 THE COURT: Not this chart, the chart 15 you earlier referred to. Is that the chart that you 16 earlier referred to? 17 THE WITNESS: No. The previous chart 18 on quotations from the literature was a different one 19 to this. n u i^ y ii `i'll 'm m u ' J H n ii 20 THE COURT: All right. 21 THE WITNESS: This is an analysis -- 22 THE COURT: With respect to the previous Q323 chart on quotations from the literature, the restriction 24 applies there as well. v. 25 THE WITNESS: I understand. f 53 Dr. Epstein - Direct < 1 ft. In the time of the deposition there was one 2 particular -study, a Ciba-Geigy study in 1974 which I < 3 took the position that it was positive. On further 4 evaluation of those data in the sense that I evaluated 5 all the data too, not only that, I have discovered that ( 6 I misread one particular table and I am changing that 7 positive result to a negative result. 48 Therefore, this is in accordance with 9 the Judge's ruling. I will restrict my comments 10 exclusively to that particular change, although there < 11 have been changes in the other direction which I am 12 precluded from discussing. 4 13 Therefore, let us come back to the 14 totality of this chart. The totality of the chart 15 demonstrates there are negative studies and positive < 16 studies. r* M M 17 THE COURT: Dr. Epstein, you do under 18 stand English, don't you? 19 THE WITNESS: I will not make any. u m , .J. 20 further reference -- s. 21 THE COURT: Not again. You have done 22 it twice so you feel it won't be necessary to do it i 23 again, is that right? Now, Doctor, don't play games *0 24 with me. I have told you, you have been told by 0324052 25 counsel, to refer to nothing after the deposition. i 54 Dr. Epstein - Direct < 1 except to correct that one mistake. Don't do it again. 2 A. Ignore the last column on results. Let me simply * 3 say that these studies are -4 1 MR. GRIFFIN: Excuse me, your Honor, 5 if we are going to ignore the last comment, can we just ff 6 take it off? If part of it is supposed to be ignored. 7 let's not play with it. 18 THE COURT: Is that the chart we are 9 talking about? 10 11 12 MR. GRIFFIN: Yes, sir. THE COURT: Yes. MR. GRIFFIN: He says they are not t 13 appropriate and there are things he says to ignore. 14 Let's not use it. IS THE WITNESS: May I just make the changer < 16 in the chart to reflect the statement at the time of thr 1 to 17 deposition? < 18 THE COURT: You may make a change to 2 19 reflect what was included at the time of the deposition 1 20 and we will block out the rest. *m 'im tiv * i* *nm 21 c 22 THE WITNESS: Thank you, sir. Could I borrow your red pen, sir? 23 V THE COURT: Counsel have in mind, of 24 course, the time limit we put on for this morning. 25 < nU Ti5l fvtBjKTifffPfTINM .; Tx wuuia l1i-xI e 4u.*o. ssiu. ^^cde +t- f ^O fiC S ^ - 57 Dr. Epstein - Direct 1 defects, and you miss it in animals, which is the worst 2 possible thin? that can happen -- in an attempt to 3 prevent this, you like to have a reasonable number of 4 animals. 5 Now, the definition of reasonable varies 6 from time to time. However, a positive result, when 7 you have a small number of animals, is very significant 8 because it means even with this insensitive test, even 9 with a small number of animals, you are getting adverse 10 effects, you are getting your cancer or your birth 11 defects. 12 So, therefore, the answer basically is 13 that you would like to have a reasonably well defined 14 study with a reasonable number of animals, that a nega IS tive inference from a study of small animals is just 16 not acceptable whereas a positive inference may well be 17 acceptable. 18 Q. Doctor, have you formed an opinion as to whether 19 or not the spraying of Diazinon at the Amtrak facility 20 at Cornwells Heights by Orkin Exterminating Company, 21 was or was not a substantial factor in causing the 22 complete unilateral cleft palate and cleft lip which 23 the infant Khristine McConnell was born with? 24 A. 2S a Yes. What is your opinion? oe u. f '' 58 Dr. Epstein Direct f 1 A. My opinion is that there is a substantial probabil:.t 2 that the exposure of Mrs. McConnell to the Diazinon r was the contributory factor or the cause of her birth 4 defect. r fit Can you explain why you arrived at that opinion? 6 A. The conclusion is based on two major sets of 7 considerations. The first is that she was exposed to * 8 a teratogenic pesticide, a pesticide causing birth 9 defects, in her first trimester of pregnancy; that is. 10 in the first three months of pregnancy. That is the * 11 particularly sensitive time when birth defects can 12 occur. t 13 And, as I indicated before, the reasons 14 for my statements on the teratogenicity of Diazinon 15 come from my evaluation of the literature and also 1 16 statements in the literature. So, that is one set 3 S 17 of considerations. i> 18 The second set of considerations relate 2 19 to the fact that there were no other known predisposing m MMU : 20 factors. There was no family history, no -- the first cg aa:t 21 child was normal, she took no teratogenic drugs; there 22 were no ether recognized causes of birth defects to whicl ^ 4. 23 she was exposed in her first trimester. So, it .rests C 24 basically on positive data, the exposure to a terato- 25 genic pesticide in the first trimester, and the negatived ( v ' VOMtN, .m Ilrf* M M 20324057 I 59 Dr. Epstein - Direct r 1 data, the absence of exposure-to other known teratogens, 2 or the absence of other known predisposing factors. C3 MR. BOLDEN: May I have a minute with 4 counsel? r* 5 (Pause) 6 Qi Did you consider any specific records or spraying 7 records in arriving at your conclusion? < 8 A. I examined the records, but have not used the 9 records as a basis for quantitative determination of 10 exposure, but'for qualitative determination of exposure. < 11 Qi How many exposures would be needed to produce 12 the result that we have been talking about? c 13 A. I can't, with due respect, answer that question 14 simply. 15 The induction of an adverse effect 4 16 such as teratogenic birth defects or carcinogenic, 17 follows what we refer to as a dose response situation. H a m , m a a a i, .*. i k ! m a im 18 The more the material you are exposed to the greater is 19 the chances, the greater are the chances of an adverse 20 effect. 21 Now, when I say the more of the material 20324058 22 I am exposed to, that is a function of two factors: V 23 one, the actual level of the material or the dose of 24 the material at any one time; and, two, the duration of 25 the time. So, you have two factors: one, the duration i * V 60 Dr. Epstein - Direct 1 of exposure to the material itself/ and/ two, the actual 2 concentrations at any one time. r3 So, the more you are exposed to and the 4 longer you are exposed to it, clearly the greater are 5 the risks. The lesser you are exposed to it, the # 6 shorter period of time, the lesser are the risks. But, 7 there isn't a stage at which you can eliminate any 8 possibility of a risk. You just say the risks are 9 lower with lower exposures and with shorter periods of 10 time. t5 11 Ql With respect to Diane McConnell, what time period 12 and what exposure were you using in arriving at your < 13 opinion? 14 A. The basic period of time which clearly one has 15 maximal interest in is the sixth to the ninth week of c 16 pregnancy. That is the most sensitive time for the * ! 17 formation of the palates. * . r ia tn < 18 Mow, therefore, the month of December 2 19 is clearly more significant than the month of October. m 1 20 However, I am not prepared to exclude the possibility ** < 41 21 that there are residues from the month of October, and Sm * 22 I can elaborate on that if you so wish me to. But, it l 23 is the month of December which clearly is the most 24 critical time from the point of view of exposure. 25 For instance, on the 7th of December, u. i* 20924053 * 61 Dr. Epstein - Direct 1 when he was seven weeks pregnant, I understand that she 2 was only present at work for a short period of time 3 that day, probably three-quarters of an hour or an 4 hour. I don't have full details on that. My information 5 on that is somewhat derivative. But, she did return 6 to work eleven days later when she was about eight-and7 a-half weeks pregnant then. Therefore, during the time 8 of the single exposure on the 7th of December, and 9 subsequent exposure on the -- when she returned to work 10 on the 18th, that is clearly a time for which one has 11 concern, and also time subsequent to that time after 12 the 18th of December during which time she was exposed 13 to, presumably, to residues in the environment. So, 14 that is one set of exposures. 15 Therefore, let me go over this, if I 16 may, a little more clearly. There was the exposures on 17 the 7th of December for a short period of time, and 18 from the 18th of December onwards. There was a 19 transient -- that is one thing. And then in addition, 20 there was a residue from the exposure on the 5th of 21 October of the Diazinon, and we can discuss this in 22 a moment; and, also, perhaps of significance, although 23 I can't be too certain of this, an impurity, a very 24 stable impurity in the Diazinon called sulfotep, which 25 is highly toxic and highly stable. rWM NMil /*. .rUUH. 20924080 ! 62 Dr. Epstein - Direct 1 So, essentially, we are discussing 2 basically the December episode but possibly residues ( 3 from the October spraying. 4 There is also one other possibility, 5 which has to be considered, and that is that there were I- 6 breakdown products in her body, persistent breakdown 7 products in her body following the October spraying. <8 We do know that for one-to-two months 9 after exposure to Diazinon there can be breakdown 10 products of the Diazinon which can be recovered from 11 the body. And, we don't know, therefore, what signifi 12 cance these have in terms of teratogenic effects. 1 13 Therefore, because of these areas of 14 ignorance I would prefer to concentrate on the December 15 spraying , particularly the December spraying on the i 16 period of time on the 7th and after the 18th, but I 17 am not prepared to exclude residues from the 5th of 18 October and -- residues in the environment from the 5th 19 of October -- residues in the environment from the 20 5th of October, especially as the literature is very c 21 clear that residues can persist for a long period of 22 time, and I am also not prepared to exclude the possi 23 bility that there are some metabolic or degradation 24 products in her body which may also have played a role 25 in the teratogenic effects. 20924061 U N I r j * 63 Dr. Epstein - Direct 1 MR. BOLDEN: Your Honor, that concludes 2 my direct examination of Dr. Epstein. But,-what I 3 would like to request the Court's indulgence for, 4 because it would only take until 11:30, I believe, 5 is that if counsel would permit me to examine Dr. 6 Hulnick, who is here, I am reasonably confident that 7 his examination should only take five or ten minutes. B THE CODRT: Do you have any objection? 9 That way we can start the cross-examination and not 10 interrupt it. We are only goinq to have a few minutes 11 anyway. 12 MR. GRIFFIN: No, I have no objection, 13 sir. 14 THE COURT: Thank you. 15 Would you step down. Dr. Epstein? 16 THE WITNESS: Yes, sir. 17 (Witness withdrew from the witness 18 stand.) 19 (The jury entered the courtroom at 20 2:35 p.m.) 21 THE COURT: Good afternoon, members of 22 the jury. I was happy to hear that you were all so 23 jolly out there. 24 You may commence your cross-examination, 25 Mr. Griffin. M M IM M U M .H M U , .i. 20924062 * 64 ( 1 (Dr. Samuel Epstein resumed the witness 2 stand.) r 3 CROSS-EXAMINATION 4 BY MR. GRIFFIN: 5 Q. Doctor, this is not the first case in which you o 6 have been engaged as a witness, is it? 7A No. i 8 Ql Maybe 12 other litigations you could recall 9 quickly? 10 A Yes, by all means. ( 11 Q. And, you have testified with respect to a number 12 of different substances, right? 13 A May I take your questions one at a time? 14 Qi I thought you answered it. 18 A I was going to answer that the -- i 16 THE COURT: Just a moment. Would you i 17 give me the question and let's see if the question 18 was completely answered. 19 THE COURT REPORTER: "Question: Doctor, 20 this is not the first case in which you have 21 been engaged as a witness, is it? 22 "Answer: No. t 23 i "Question: Maybe 12 other litigations 24 you could recall quickly? 25 "Answer: Yes, by all means." Mramii. ij .^ hmm 20924063 I 65 1 Dr. Epstein - Cross THE WITNESS: I am sorry. I didn't 2 hear "twelve. 3 THE COURT: Did you say twelve? 4 MR. GRIFFIN: I was not asking him to 5 list them. 6 THE COURT: No, no. Did you say 7 twelve? 8 MR. GRIFFIN: I said twelve. 9 THE WITNESS: I am happy to accept 10 that. 11 A. I haven't testified that number of times, 12 ft The various cases required many different substance 13 A. That is correct. 14 ft Am I not correct that in everyone of those cases 15 other than this one, you were really testifying about 16 carcinogenicity? 17 A No, that is not true. 18 ft Have you testified about teratogenic effects 19 cause and relationship in any of those cases? 20 A No. Teratogenesis was not the issue, but 21 carcinogenesis also was not the only issue. For 22 instance, there was a case in 1974 or '75 -- 23 ft Well -- N 24 A -- in which workers were exposed to a chemical 25 that produced, in a plant in Columbus, Ohio, and this MINC. H J. 11^ . r i M H * N M il 1901^C0 ! 66 Dr. Epstein - Cross 1 chemical produced paralysis in workers, and I testified 2 on behalf of that. So, there have been areas other 3 than questions of cancer. 4 Q. Well, for my purposes, to put it the other way 5 around, you have not testified in a case before claiming 6 that there was a cause-and-effect relationship between 7 a chemical and a birth defect. 8 A. Correct, sir. 9 Q. When you were engaged in this case, did you 10 consider whether you should tell the plaintiffs' 11 lawyers they should get themselves a teratologist? 12 A. I made it very clear to the counsel for plaintiff 13 what my areas of expertise are and have been, and what 14 in what areas I could be helpful to them. I made it 15 clear to them that I wasn't a bench teratologist in 16 the sense of doing experimental work on teratogenicity, 17 but I also pointed out that I had had extensive 18 experience in the evaluating of teratogenic hazards, 19 teratogenic data, and in the formulation of opinions 20 on risks of birth defects from people exposed to 21 teratogens. That I made explicitly clear to Mr. Bolden w 22 at the time when he first approached me. 23 {?. Doctor, my question was, did you consider referring o cn 24 him to a teratologist? wl 25 A. I said to them that I was not a bench teratologist-1- . inn i p iiiu ^ u ih m , M ! 67 Dr. Eostein - Cross 1 Q. I am not asking you what' you said to them. I am 2 asking, did you consider referring them to a teratolo- 3 gist? 4A Yes, I did. 50 All right. In the course of that consideration, 6 did you come up with the name of a teratologist who 7 you thought would give the kind of testimony you have 8 given in this case? 9A Well, I -- that would be presumption on my part 10 to predict what testimony another expert would give. 11 Ql You know men all over your toxic field, don't you, 12 or throughout the country, you have been on panels and 13 you -have worked on governmental things, you know men 14 in this area, don't you? 15 A But I do not predict or would not be so presumptuoi. 16 to predict the nature and the type of testimony that 17 another expert would give, especially prior to their 18 evaluation of the data. 19 Qt Let's just put it this way. Doctor: If somebody 20 comes to me with a question, with a legal question, 21 and I say to myself, I understand that question, but 22 that is not really in my field. I would know people 23 around the country to whom I could refer who do know 24 the answer to that question and who are specialists 25 in it. < w * "r * m au 20924066 68 Dr. Epstein - Cross Now, my question to you was, you consider ec that because you told me you considered it. Now, secondly, my question was, did you come up with the name of anybody in all this mass of people you know who you knew was a teratologist who you could expect to give the kind of testimony you are giving here? A. I repeat again, I would not presume to predict the nature of a testimony of another expert witness. I am perfectly happy to give names of people who they could go to get the data evaluated, but I reject the implication in the question that one can simply address a list of experts and say, ah, yes, they will testify favorably on unfavorably. I reject that most emphat ically, sir. Qt That may be unfair. Doctor. Let me put it this way: Knowing the case as you knew it, did you make any references to any teratologists whom they should go and consult? A. That is your question? Q. That is my question, yes. A. The answer is yes. fit And to whom did you refer them? A. I referred them to a teratologist, a Dr. Manson, in the University of Cincinnati. 20924067 69 Dr. Epstein - Cross 1 Q. Anybody else? 2A No. 3 Cl All right, sir. 4 You have been in court enough to know 5 that a witness is supposed to be sworn before he 6 testifies, right? 7A Correct. 8 Ql 9A 10 Cl And, you weren't here. I beg your pardon? Were you? 11 A Most certainly, sir. 12 Ql My recollection was that you were not, people 13 around me said that their recollection, when I asked 14 at lunchtime, their recollection was you were not. IS Were you? 16 A 17 CL 18 A Indeed, sir, I was. Were you in the witness stand when it happened? I was not on the witness stand. I was facing the 19 court reporter. 20 MR. GRIFFIN: Did you? 21 THE COURT REPORTER: Yes, sir, I did. 22 MR. GRIFFIN: I am sorry, that is a 23 misunderstanding. 24 THE COURT: Mr. Griffin, if it did not 25 happen it would be the first time in my courtroom. 69UZG uZ * 70 < 1 Dr. Epstein - Cross MR. GRIFFIN: I am sure of it, Judge. 2 That is the reason I thought it was very unusual, but C 3 that was our recollection. We probably were working 4 on something else. 5 THE COURT: As a matter of fact, a 6 witness does not even reach the witness stand without 7 having been sworn. That is our practice. 8 MR.GRIFFIN: All right, sir. 9 BY MR. GRIFFIN: 10 Qt Now, Doctor, let's get to the substance of the C 11 opinion. 12 As a scientist, can I -- is it fair ( 13 to say that if you are trying to prove or give a w 14 scientific opinion that there is a cause-and-effect 15 relationship between exposure to a substance and an 16 end result in man, you have to go through at least * *s 17 some steps of the reasoning process. C 18 A Certainly. m* 19 Qi Is it fair to say that you should say to yourself, *m m * 20 I have a substance which in my best judgment is i 9 21 teratogenic in man; that is one step, because if the xm 22 substance was not teratogenic in man that would be the i 23 end of your search right then, wouldn't it? 24 A With due respect, sir, I have to disagree. The 25 first question you ask yourself is, is there any 20324069 ! 71 Dr. Epstein - Cross evidence that the agent is teratogenic, not necessarily in man. ft No. That was part of the process I was going to go through. A. I beg your pardon. Cl You have to find in course, in your own judgment that the substance is teratogenic in man. A. No, sir. Ql Well, you have to get there soon or later, don't you? A. No, sir. May I attempt, with due respect, to explain the process. The process is essentially to analyze the experimental data on the teratogenicity and see whether indeed this supports the inference that there was a substantial probability that the material is teratogenic in animals, or if the material is terato genic in animals. That is point one. On the basis of that, one makes the reasoned presumption on the basis of which all toxicology is based, that one can extrapolate from the animal to to the human. So, the point of fact relates to the findings of teratogenicity in animals. From that, one makes the reasoned presumption of a likely teratogenic hazard in humans. That is the process. M C Q N O o 72 Dr. Epstein Cross C 1 Q. I was really going to go through that process 2 in arriving at the fact that before you can complete 3 your chain of reasoning you have to have established 4 that the substance is teratogenic in man. 5 A. No, sir. There was a strong probability that 6 it is teratogenic. 7 Qi Well, that's -- 8 A. I have not made the statement it is teratogenic 9 in man. I have made the statement, I believe this 10 morning, that there was a strong probability that it 11 is teratogenic, which, sir, with due respect, is M.i. I f ^ t rNM 9M 12 different than what you quoted me on. 13 Q. That is different from saying it is. 14 A. Precisely. 15 Ql You are saying in the scientific world that's 16 different. 17 A. I am stating in any world it is. I do not wish 18 to be misquoted. 19 Ql Suppose I say that as far as we lay people are 20 converned, if there is a strong probability that it is 21 we would accept that as saying well, if there is a 22 strong probability, it probably is; fair enough? ^ 23 A. That is your inference, sir. ^ 24 Q. Well, you -- you nevertheless -- I will put it 25 Q on the negative. If your scientific knowledge convinces 81 Dr. Epstein - Cross 1 these can be done for you -- one part per trillion of 2 Diazinon is not one molecule, it is not a million mole 3 cules, it is not a billion molecules, it is not a 4 trillion. It is more than a quadrillion molecules, 5 and that is the ball park, if you like, we can frame 6 this discussion. 7 BY MR. GRIFFIN: 8 Qi Well, let me go back to your deposition when you 9 were being deposed upon the levels you were talking 10 about in order to give your opinion at that time. 11 A. Yes. 12 Q. Now, you say here, among other things, on page 13 69, "So, we are dealing with exposures that were not 14 trivial, and if you want to follow my line of 15 reasoning that the dosage required to produce minimum 16 symptoms is in the region of 50 to 80 milligram." 17 And, that is over -- "And, there are 18 references to support that. There is documentation 19 to support that. That's equivalent, say, to a 20 milligram per kg body dose." 21 Now, when you are talking about a 22 milligram per kg body dose, you are talking about 23 one milligram per what? 24 A A kilogram of what he weighed. 25 ft Right. And, translated into something like the 82 Dr. Epstein - Cross 1 TLV, the Threshold Limit Values, what does that mean? 2A I really couldn't do an off-the-cuff translation, t 3 but it is very much in excess of that, 4 fit "This was going on repeatedly. It is not just 5 one occasion an element like Diazinon, although it 6 isn't very stable and persistent material. We do enough 7 of it staying around after a spraying to make people 8 sick when they returned." You knew that, didn't you? 9 A. What is your question? 10 ft That was a premise for your opinion in those * 11 days, wasn't it, that there was an exposure of such 12 an extent that it caused people to get sick when they % 13 came back the next day? 14 A. Well, certainly. What you have read is several M IN 15 things, and I am not certain if you want a yes or no 16 from me or you want me to comment on any part, s 17 ft Well, that is what you testified to before, isn't 18 it? 19 A. Yes, I certainly did testify to that, 20 ft All right. 21 Then, "Well, is your basis for believing 22 that there were incidents like that earlier in her 23 t pregnancy?" And you said, "Well, I am told again that 24 there were multiple exposures to Diazinon in the first 25 trimester. The dates, I have a couple of them." v M M M I . N IIR M . R.I, i r . 0324081 83 -84 Dr. Epstein - Cross Now, by multiple exposures, did you mean exposures of the kind that made people sick when they came back the next day? A By multiple exposures I meant exposures which wwerti more than one. ft And, by exposure you mean exposure to more than one molecule? A Well, we didn't discuss the number of molecules there, but I have already indicated to you that we are dealing, if you want to translate this into mole cules, you are dealing in the very, very high orders of magnitude in terms of more than quadrillions. Ct Just dealing in terms of human experience, what is the experience to your knowledge of people coming in contact with molecules of Diazinon day in and day out, everywhere they go? A I am not clear what the question is. Is it relating to birth defects, what is it relating to? CL I am just talking about people's exposure to that particular chemical. Are people exposed to it a lot or aren't they? A Well, certainly people who formulate and manufacture the material do have fairly constant exposure and people 2032-1082 n Have you ever heard -- * 85 Dr. Epstein - Cross ( 1 A. Excuse me. 2 Qi One at a time. If you will just tell me the *3 people who are exposed, I will ask you after each 4 one. e 5 A. Please let me finish. 6 Qi Have you ever -- 7 THE COURT: Mr. Griffin, let him finish t 8 his answer. 9 You do pretty well asking questions. 10 Give him a chance to answer. ( 11 A. What I was going to say was that people who 12 tend to have sustained exposure would fall into several 13 categories. First of all, manufacturers and then 14 formulators and then applicators; in other words. 18 people who actually manufacture the material, people ( 16 who take the material once it is manufactured, make * SOk 17 it up into solutions or preparations which pesticide i k applicators cna then use; and then the third are 2 19 pesticide applicators, people who actually apply the k I 20 material in homes or buildings or for agricultural \ 21 m* purposes. Those are really the three major categories 5 22 of people that have sustained exposure. 23 I am unaware of the likelihood that 24 pregnant women would fall -- would be occupied or 28 employed in those three categories, but I can't exclude 1 a m M h i hum 20324083 1 * 86 Dr. Epstein - Cross i 1 that possibility. 2 Qi Well, you would assume, don't you, that there are < 3 some pregnant women who do gardening. 4A There is nothing I have said which would lead you 5 to a contrary assumption. 6& And would you think that some of them would use 7 Diazinon? It is a very common insecticide, isn't it? 8A I would not be willing to exclude that possibility 9 Qi And, in using Diazinon they become exposed to it 10 in one degree or another. c 11 A Possibly. Certainly. 12 C- As far as experience is concerned, do you know of 13 any case in the entire world where somebody, because 14 of being exposed to Diazinon had a teratogenic effect? . raaa im 15 A I have no idea of this. Largely, because the < 16 vast majority of birth defects -- and, I can tell you 17 that the incidence of birth defects is not trivial. In 18 the vast majority of incidences of birth defects there 19 have been neither investigation nor inquiry into . mhu 20 possible causes. And, in fact, to produce an answer 21 to your question, one would have to have a very long -- 22 large-scale epidemiological study with a large number 23 of women exposed to be able to develop such inferences 24 of the kind you are inquiring about. 25 Ql There seems to me that there is a fundamental t V. tAvoMMK, a .t.^ 180^260 87 Dr. Epstein - Cross 1 difference here between us. 2 In the courtroom, you know, what we 3 are trying to prove is the fact, right? the fact, not 4 the question of what might be or what could be, and, 5 to the extent, as I see it, to the extent that science 6 has not yet given us an answer, to the extent that we 7 are still in the realm of that's the world and that's * 8 God, and that all those things we don't have answers 9 for, we say they are not provable. Do you think 10 differently from that? 11 A. Yes, sir, sir, I think I understand what you are 12 driving at. The situation here is, we know that this % 13 lady, during her pregnancy was exposed to a pesticide 14 for which the substantial preponderant evidence in the 16 literature demonstrates that it is teratogenic, period. % 16 Therefore -- mi am 17 Ql 18 A. Wait a minute. Teratogenic in where? Would you please not interrupt my answers and 19 then I think we can proceed more expeditiously. 20 -- was teratogenic in a series of 21 experimental animal systems. And, on the basis of this, 22 this offers, this presumes a potential human teratogenic 23 hazard because of the preponderance of evidence in the <u w 24 literature there is a presumption this agent is also w t) 25 teratogenic in women. * 0 00 01 n ^ m au 88 Or. Epstein - Cross We also have some evidence of persistence of these materials, we also have evidence that there was an exposure roundabout the time of the critical / time of the formation of the palate and lip. In addition to this, there was no other known -- she was 89 < 1 Dr. Epstein - Cross I think really what it called for though 2 was a short definition of epidemiology. And, I would *3 request that you answer the questions that are posed 4 to you. There is a danger in delivering lectures. S 6 THE WITNESS: All right, sir. Epidemiology is basically the study of 7 adverse effects in human populations. In other words. * 8 what evidence is there in human beings of cancer or 9 birth defects. Are these related to ethnic factors, 10 to race, to religion, sex, exposure to various chemical!! < 11 in the environment. And, one of the problems about 12 epidemiology is, like toxicology, it is very insensitive C 13 And let me explain this. 14 To develop inferences -- 15 ft Doctor -- 16 THE COURT: I think we passed the \ 17 definition sometime ago. All right. 1 18 Mr. Griffin, please, please avoid the 2 m lecture soliciting-type of questions. Now, make them 1 20 precise. \ 21 MR. GRIFFIN: It is difficult. aM% 22 Q. Am I not correct that as far as epidemiology is 'I 23 concerned, there is no demonstrated connection between j 24 Diazinon and human experience? . , 25 A The absence of data in no way implies safety. i 1 Wi r ! ,* w n m 48012602 1 98 Dr. Epstein - Cross 1 did not discuss this at that time of the deposition. 2 Now you are putting me in a difficult position now c 3 because if I refer to this again I risk being in 4 contempt of court. 5 r THE COURT: You are relieved from that 6 if you can point out anything in the literature that 7 sets forth the standards in answer to Mr. Griffin's 8 question. 9 A. I am unaware of any governmental standards on 10 birth defects. These were under consideration at the 11 time of the Carter Administration but have not been 12 promulgated in this present Administration. < 13 Cl Now -- 14 A That is in relation to occupational exposure. 15 THE COURT: Mr. Griffin, let me c 16 interrupt for a moment. * 17 Counsel at counsel table are cautioned fM N 18 to make no facial expressions whatsoever. 19 A I beg your pardon. In relation, say, to consumer 20 products in drugs, the FDA, I think, takes very clear N M tl *7. 21 and unequivocal action on this. And, let me just 22 very briefly state what this was. 23 i 24 Subsequent to the thalidomide episode. MR. GRIFFIN: Your Honor, please. 25 A You asked me C? ( 14, i r * 092409 I 99 Dr. Epstein - Cross MR. GRIFFIN: Your Honor, drugs and the FDA, I think we are just getting beyond our ken. THE COURT: We are dealing here with the 4 question of the effects of Diazinon. Let's move on. 5 The next question, Mr. Griffin. 6 Qi Now, is it correct. Doctor, that in 65 to 70 percent 7 of all cases of developmental defects in man, that the 8 cause is unknown, flat out unknown? 9A 10 Q. I think that is fair to say that, yes. I Talking again about man, what substances are there 11 that have been shown of all the different substances 12 we have, what substances are there that have been 13 shown to be teratogenic in man as differentiated as 14 being teratogenic in animals? 16 A Do you mean -- when you say, as opposed to, do 16 you mean when the animal data are negative? 17 Q. No. I mean -- forget all animal studies. I am 18 just asking about what has been shown to the extent of 19 present day knowledge of the scientific community, 20 what substances are teratogenic in man. 21 A Okay. Well, the causes of birth defects -- 22 Ql What substances are teratogenic in man? 23 A Okay, fine. 24 Well, substances fall into various 26 categories. First of all, infectious, like German m n iiii f*' miimv. n. .i i w 0924097 i 100 Dr. Epstein - Cross < 1 measles. Is that responsive to your question? 2d It is ambiguous. I wouldn't have thought of it c 3 as a substance, but if you do -- 4 8 A. May I simply answer your question in relation to 5 the risk factors or predisposing factors of birth defects 6 which would allow me to make reference to infectious 7 agents which aren't in your understanding substances, 8 okay? m w i> i. .i. U *T ' ^ 9d Okay. 10 A. Fine. So -- well, the first is, I suppose, 4 11 genetic and familial predisposition, which is one 12 factor. That is important. There is a genetic and 13 familial predisposition. 14 There are ethnic factors. For instance, 18 Orientals have a higher incidence of birth defects, < 16 particularly in cleft lip and cleft palate than non17 Orientals. 18 The maternal x-rays, radiation, which 19 isn't a substance, but is an influence, an adverse 20 influence, and maternal radiation is an important cause; 21 infectious agents, like rubella, German measles; drugs, Mm m 22 a series of drugs have been shown to induce birth Im 1 23 defects, such as thalidomide, which we have repeated, 24 meclizine, a drug used in the treatment of morning 25 sickness; Aminopterin, a folic acid antimetabolite; 1 0324098 101 Dr. Epstein - Cross c 1 anticonvulsant drugs, drugs used in the treatment of 2 maternal epilepsy; then a series of toxic chemicals, c 3 particularly methyl chemicals like methylmercury, and 4 then this may not be totally responsive, but there is * 5 an interplay of these factors, what we call multi 6 factorial influence; that is, the interaction of 7 exogenous factors, such as infection, or chemicals, or < 8 what have you; and, genetic susceptibility. 9 In other words, it is possible that some 10 people have a built-in genetic susceptibility. That 11 coupled with the environmental exposure, whether it be 12 a drug or pesticide, or what have you, the two of < 13 them are important. 14 So, I think we have to bear in mind, 16 in addition to the exclusive external factors, and c 16 interplay with internal factors or genetic predisposi ms 17 tions. That is just an off-the-cuff listing. < 18 Qi But still, if you have a birth defect, and if you 19 take into account all the things you know which may 20 cause it, you still end up with 65 to 70 percent of i 21 them that you just can't attribute anything to. 22 A. It is not you can't, sir. I wish that was the i 23 case. Unfortunately, the overwhelming majority of 24 birth defects haven't been studied. We don't even, 26 in this country, have a birth defect registry. I 20924099 102 Dr. Epstein - Cross I am consultant on birth defects* on cause of birth defects to the March of Dimes. One of the things we are trying to do is set up a national registry. Sweden has a national registry. We don't have one in this country. So, we don't have the baseline data on human birth defects. But, -- even, for instance -- Qt But -- A. Excuse me, just one second. The occupation, maternal and paternal occupation is not listed on birth certificates in this country. One of the things we have been trying to do just to answer your kind of question as to what maternal influences possibly could have had an effect on the birth defect, we don't have the information. But, it doesn't mean to say the influences, the environmental influences aren't there. You must not equate the absence of data with the absence of a causal association. Q, But, it doesn't mean that they are there either. A. I couldn't agree with you more. Q. It doesn't mean one way or the other. You just don't know. OOIioGO A. That's right. Ql And, in 65 percent to 70 percent of the cases, based on the present scientific knowledge, you don't < 103 Dr. Epstein - Cross 1 know what it is. 2 A. Not based on the scientific knowledge, because 3 nobody has really looked. It is an absence of data. 4 Qi Then, based on our knowledge as human beings, we r 8 don't know. 6 A. Based on the absence of data. 7 Mr. Griffin, if you will t 8 simply revise your question, based upon lack of knowledge 9 then. Perhaps you will accept that. 10 < Ql There is not adequate knowledge. 11 A. There is a lack of knowledge. There's almost an 12 absence of it. < 13 ft Now, for the purposes of our discussion from here 14 on in, would you take the words "lack of knowledge," 16 and "no", as the same thing? ( 16 A. No, I most certainly would not be prepared to do 17 that, sir, with due respect. 18 Qi If, as a scientist, you don't know the answer to 19 something, for the purposes of proof, can't you accept 20 the proposition that it can't be proved? 21 A. Most certainly not, and let me explain why. 22 In the majority of instances of consumer 23 i product safety, pesticides, there is a massive lack of 24 information in the published scientific literature. 25 However, there is a great deal of information in industry i ' m i. 1 .1. ! r n , mhm 20924101 ! 104 Dr. Epstein - Cross c 1 files which industry has resisted making available for 2 scientific inquiry and exposure. Now, is one to say that because there 4 is no data in the open published scientific literature there is no hazard, when knowing full well that there 6 may be very extensive data in industry files. And, I 7 have had extensive experience as a government witness 8 looking into industry files for data which have never | 120 Dr. Epstein - Cross 1 Ql And I got an abnormality. 2A In just one animal, in just one litter, one baby 3 in one litter, one would say well, look, you now, this 4 is nothing to write home about, go and get lost, chum. 5 One would not be interested in that. 8 If, however, in two or three litters of 7 these four animals you had unusual birth defects and 8 none in the controls, and in fact when you looked up 9 your agency files you found that there were half a dozen 10 other of these experiments, all of which with varying 11 degrees of animals showed positive effects, one would 12 say, now, look, this is very interesting. Why don't 13 we mount more studies on this strain of animals which ha$ 14 not been done, incidentally, on the two positive strains 18 of rats, why don't we mount large-scale studies on the 16 mammalian species like pigs and dogs? That's the respond 17 for one to have. And, in fact, the results with the 18 i pigs and dogs you see down there are positive and 19 equivocal, you have two positive results in rats, in 20 two strains of rats, the Wistar rat, the Sherman rat, 20324118 21 and the Ciba-Geigy you used a different strain. 22 Qi Are you mad at me? 23 A No, not in the slightest. I am trying to explain. 24 I think we are developing a reasonable pattern of 25 communication at last. 121 Dr. Epstein - Cross 1 ft Can't you turn off a little after I just ask you 2 a simple question, can't you just give me a simple V 3 answer? 4 A. Hell, I am trying to be as helpful as I can to you, 5 but it appears that a certain amount of repetition is 6 necessary. Otherwise you ask the same question twice, 7 ft Well, I am simply trying to find out whether one 8 unusual result in a litter of four animals would be taken 9 seriously? I think you told me no, it wouldn't. Then 10 you went on to a long explanation as to why -- C 11 A. No. You changed your question. Initially you 12 were talking about one litter -- one animal amongst 13 four, and then I tried to find out from you whether you < 14 were talking about one baby in four litters which may 15 be one in fifty. There is a difference, 16 ft At least then the process of evaluating these 17 different studies to say whether they give you evidence 18 that is meaningful should be done by people who know 19 their business, and I assum you are holding out to. me 20 that you know your business. You say, by gosh, I am 21 good at this. 22 A. Well, those weren't my exact words, but I am willinc 23 to accept your paraphrase. 1 24 ft All right. Now let's go here. You have some 25 studies up here and you have a plus mark on some egg 1 *>*(, J. A IH I * rotn M l 0924113 i 122 Dr. Epstein - Cross ( 1 studies. Do they recognize egg studies as being good 2 studies? Do they tell you something about -- c 3 A. Well, to be quite frank, I have done a vast amount 4 of egg work myself. 5 Ql For godsakes, doctor, don't tell me what your e. 6 opinion is. Do they? 7 A. I was just going to comment to say, in general, I 8 think the position amongst most people is that it 9 would be pretty rash to develop clear inferences on 10 the basis of egg data. And, I share that too. I would 11 be very unhappy about accepting clear inferences of 12 positivity on the basis of egg data. 13 t All I think that the egg data can do is 14 to show you whether or not the material is suspicious 15 and the degree of suspicion. So, I would say the answer c 16 is, you shouldn't rely on egg data in a definitive m* m 17 fashion, but it is reasonable to take the position that >to 18 it provides you suggestive data. That's the kind of ! 4 a 19 thing. it is a screen test. a a 20 Ql Is it reasonable to say that a subject is -- to be I 3 21 teratogenic, a substance has to cross the placenta a * 22 barrier and affect the fetus? 23 A Yes, I think so. And, this is the reason why l 24 one has certain reservations about drawing hard and 25 fast inferences from egg data. I fully accept this. ( 20924120 ! 123 Dr. Epstein - Cross f 1 Qi And the placenta barrier -is the covering around 2 the mammalian fetus? C 3A You are absolutely right. There are differences/ 4 clear differences between the egg, the physiology of the 5 egg in chicks or ducks, and the physiology of a human C 6 egg, the human embryo. And, for this reason, I think 7 one has to be cautious, although in fact the FDA studies < 8 have shown a fairly interesting concordance, or 9 similarity between some of the chick egg studies and 10 some of the rodent studies. 11 Qi Now, Doctor, pick out for me, if there is one, the 12 one study on which you put a plus that you think is the t 13 most important study supporting your opinion. 14 A Well, you know, I said very clearly in the deposi 15 tion that I am relying on the aggregate of the data. ( 16 I am not prepared -- I was not prepared then, and I am *m sto 17 not prepared to say now that this study is the most l 18 important 19 What I am saying is, we have several 20 positive studies; each of them which have different 21 strengths and different weaknesses, and the aggregate 22 of all of these I find persuasive. As indeed many other 23 authors in the literature also find persuasive. i 24 Ql Like whom? W* r* 25 A Well, I may be in contempt of court if I go into Cvi c I 124 Dr. Epstein - Cross ( 1 this again, but we already had a chart this morning 2 from which you insisted that I excluded several authors C 3 who made statements on teratogenicity of Dia2inon. If 4 you would like me to go over these and with the consent 5 of the Court, I will do so. 6& 7 Well, we have taken a lot of time already. This Kimbrough and Gaines study in 1968, 8 did that have an adequate number of animals by today's < 9 standard? 10 A. Well, that is a good question. I said before that < 11 today's standards, in general, tend to like about ten or 12 so animals per dose level. I would say that on a whole 13 the Kimbrough and Gaines Study was a bit short on animal*: t 14 It had four to six animals in a group, in a test group, 15 and it had four to six animals in controls. But, there i 16 were three control groups in the Kimbrough and Gaines t 17 Study. f . 18 ! Furthermore, the losses, the birth i 19 defects which you got in the Kimbrough and Gaines Study 20 were extraordinarily similar to the birth defects in 3< 21 found in the Dobbins Study. That is the study immediately I 22 above. Those two. Very similar birth defects. 23 The Dobbins Study was with Wistar strain N c 24 of rats; the Kimbrough and Gaines Study was with the 25 Sherman strain of rats, and both of them found renal 0924122 I 125 Or. Epstein - Cross i defects of the -- defects of the renal tract. Very 2 interesting. f3 So, when you say to me, do I exclusively 4 rely on the Kimbrough and Gaines Study, the answer is 5 no. It is a study I would like to see more animals in ft 6 it. However, there were three groups of controls, there 7 were birth defects similar to the defects found in other 8 studies, and these, I think, are very very interesting 9 indeed. 10 Ql Well, Doctor, I am basically going to give up on &C 11 you because I just can't keep going and all I asked 12 you -- the only question I asked was, in the Kimbrough 13 and Gaines study was there an adequate number of rats 14 by today's standards. It seems to me you can answer that 18 yes or no, and it took -- it took 15 minutes. C 16 At any rate, in judging whether these #m 9 X 17 studies are indicative of teratogenicity in man, people 18 could have a difference of opinion with yours, couldn't l i 19 they? m m 20 A I would say that if you show data of this kind where i l m 21 you have several positive studies in animals, when some a 2 22 of these studies show similar birth defects in different Y tC o 23 species, on different strains, the most some people -l 24 you might have a difference of opinion this way: Some 25 people would say there is a high degree of probability I 126 Dr. Epstein Cross c 1 this is teratogenic in humans; others would simply say 2 there is a possibility, or there is a suspicion. I am ( 3 willing to accept the fact that there may well be a 4 difference of opinion between some scientists who say 5 there is a suspicion that this produces birth defects 6 in humans, or those who go stronger and say there is a 7 high degree of probability. In that respect I totally ( 8 agree with you, between good men of -- and women, excuse 9 me, but in good people of faith and training in the 10 area, there could well be a difference of opinion between C 11 those who look at data of this kind and talk about 12 suspicion of teratogenicity on the one hand or proba ( 13 bility, that I fully accept. 14 & Do you know Dr. James G. Wilson, don't you, or of 15 him? 16 A. Yes, I do. 3a l9 * 17 Q. Do you accept him as a competent authority in the i. 18 field of teratogens? 19 A. Certainly he is a most competent bench teratalogist 20 but I wouldn't accept him as authoritative in the area Wmm 21 of human risk evaluation. 22 Q. Well,' you would accept him as an authority in the 23 field of deciding whether various tests indicate I 24 teratogenicity in the animals? 25 A. As I say, I think the man, Dr. Wilson, is certainly 127 Dr. Epstein - Cross 1 a most competent teratologist. There is no question 2 at all. 3 Of his professional ability in the 4 area of risk assessment -- and we have had differences 5 of opinion on this which I would be happy to discuss 6 with you if you care to, I would, with due respect, 7 raise some guarded qualifications, and, these qualifi 8 cations, incidentally, have been shared by governmental 9 agencies,and the Administrative Environmental Protection 10 Agency rejected recommendations of his committee of a 11 committee which he chaired on ability of 245T to 12 produce birth defects. Dr. Wilson looked at a great 13 deal of data in 1972 on 245T, a herbicide for which 14 there was overwhelming evidence on causes of birth defects 15 -- this is the Agent Orange chemical -- and he came to c 16 the conclusion that there really wasn't much hazard * i 17 in this and I took a different position and the 18 adminstrator. of the Environmental Protection Agency, in i 19 an action unprecedented in the regulated history of the r* im k iii W ln m 20 United States rejected the opinions of his advisory 21 committee, including the opinions of Dr. Wilson. 22 So, as I said before, I think in terms 23 of experimental teratology, fine; in terms of human 24 risk evaluation, with due respect and -- really, with 25 due respect I would question his ability to make 128 Dr. Epstein Cross inferences on risk assessment. ft If your are criticizing, Doctor -- 1 take it that was a criticism of Dr. Wilson? A. No, no. I said that I think that he is highly 129 Dr. Epstein - Cross 1 same question repeatedly, and I am willing to repeat my 2 answers, but I am afraid by doing this we are trying 3 the patience of the Court. I have already answered 4 very substantively, and if you wish me to repeat this, 5 I will. 6& I don't want you to repeat it. God only knows, 7 I'm not sure where we are, to tell you the "truth with 8 that answer. You simply -- I gather you are saying, 9 yes, you accept Dr. Wilson as am eminent authority, 10 but there was an instance in which he and some other 11 people in the government disagreed. 12 A. Sir, you do misquote me, and, really, this is most 13 unfortunate. 14 What I said was that Dr. Wilson is 15 a most experienced and an excellent bench teratologist. 16 He has done very fine fundamental studies on teratology 17 in animals. 18 When it comes to human risk assessment, 19 the question of assessment of risk to humans, he has 20 been characterized by many as highly conservative. And, 21 the instance I have given you of a committee which he 22 chaired and which is recommendations on public policy 23 were ignored and rejected by the federal agency to whom 24 he was reporting, this is an example of questions that 25 may be reasonably direct on his qualifications in the 130 Dr. Epstein - Cross 1 area of risk assessment. 2 Now, I hope that is clear, sir. 3 Ql As far as you are concerned, what does "Nature 4 Magazine," think of you? 5 A. Well, "Nature Magazine" is a journal that publishes 6 opinions from qualified scientific people. A journal 7 never thinks of, be it all badly, of anyone. A journal 8 is prepared to publish opposing viewpoints and opposing 9 viewpoints of positions I have taken have been published 10 in "Nature" and elsewhere. 11 Ql So, we don't want to get into incidents where 12 somebody has not gone along with somebody else. 13 A I am not really talking about incidents. I am 14 talking about the fact that when recommendations on 15 public policy effecting the lives of millions of women 16 in this country are concerned, he made a recommendation 17 that it was no hazard from 245T. The scientific data 18 were contradictory to that, and I was involved in 19 marshaling of the scientific data which took a contrary 20 position and presenting this in Washington and the 21 Admistrative Environmental Protection Agency decided i 22 with due scientific advice to reject the recommendations 23 of Dr. Wilson that indeed 245T was safe. And, the 2 T t? .e o 2 24 subsequent experimental data in the last ten years has 25 confirmed the fact. We have dozens of experiments now, 137 Dr. Epstein - Cross 1 an overwhelming majority of cases with birth defects 2 that are never investigated. 3 ft All right. Are you an investigator of birth 4 defects? 5A I think I have discussed my professional expertise 6 in some detail this morning. I do not make a profession 7 out of investigating birth defects. I have advised 8 governmental agencies, I have advised and still advise 9 the March of Dimes how to go about studying this, but 10 I do not spend my time exclusively in these areas. 11 Qi Okay. Are there people who do? 12 A Certainly. Certainly. There are some epidemiolo 13 gists, particularly in the Center for Disease Control, 14 who do their best with the very limited data they have. IS But, as I said before, the basic information which you 16 need, namely a birth defects registry, or parental, 17 maternal and paternal occupation on birth certificates, 18 we don't have these data, but, nevertheless there are 19 epidemiologists in CDC and elsewhere who study these 20 matters, and there are experimentalists who study these 21 matters, and there are people in the area of risk 22 assessment too. There is a wide-range of areas for the 23 data base. As far as humans are concerned, to say the 24 least it is grossly inadequate. r: c 2S Ql Are you and epidemiologist? a CO -1 138 Dr. Epstein - Cross 1 A. NO. 2 Ql Would you rely on another epidemiologist if you 3 wanted to know something about epidemiology? 4 A. In general, when I have problems in epidemiology 5 I discuss these with colleagues in the field and take 6 opinion and advice from those who are recognized as 7 being professionally competent in the area, certainly, 8 ft Doctor, do you know when Diazinon was created? t 9 A. Created? That is a strange word. What do you mean 10 by that? 11 ft Well, did it come to us with the formation of the 12 earth? It is not a natural compound, is it, or is it? 13 A. Do you mean when was it synthesized? 14 ft Whatever you want to make it. 15 A. Okay. Well, that is different. I believe a I 16 patent was taken out in about '51, to the best of my 17 memory, and Ciba-Geigy started marking it in about 1954. 18 That is to the best of my recollection. I may be off k 3 19 by a few years, that I think that is basically the -- 20 I may have some -- I think that was -- yes. I think it na h i s e iz e d 21 was marketed in '54. Sure. 22 ft How long has man been on this earth? 23 A. Well, you know, it depends on whether you are a 24 creationist or not, and I am not sure this Court would 25 permit a discussion of evolution in this area. I just 139 1 don't know. Dr. Epstein - Cross 2 ft Will y.ou accept a million years? 3 A. I am willing to accept any hypothetical you 4 willing to offer. are 5 ft When did cleft palate first appear on this earth? 6 A. Well, you know, in the ancient papyri, I believe 7 there are records in times of Egyptians of birth defects . 8 including cleft palates, 9 ft Did the Egyptians have Diazinon? 10 A. To the best of my knowledge, no. I think I told 11 you that Diazinon was synthesized about 1951, and I am 12 not sure at what point the repetition of the question 13 is. If it was synthesized in 1951, how could the 14 Egyptians have been using Diazinon; the early Egyptians, 15 the ancient Egyptians, I mean. 16 On the other hand, there have been many 17 instances of acute toxicity in organic phosphate 18 pesticides in Egyptians, Egyptians in the course of the 19 last decade or so, including massive numbers of buffalo 20 kills from organic phosphate pesticides which were 21 manufactured in this country and exported without any 22 labels or warning on these problems to Egypt. I am 23 willing to discuss this, if you so wish. That was 24 an Egyptian episode. 25 ft Well, let me just get this straight, leaving the 140 Dr. Epstein - Cross 1 Egyptians in or out of this. Cleft palate and cleft 2 lip certainly came long before Diazinon. 3 fc. Oh, you are absolutely right. 4 Qi Thank you. 5 Well before Diazinon, what would we 6 blame cleft palates on? 7 A. I had gone through a list of risk factors in respond 8 to your colleague's question. Would you like me to 9 repeat the same list of risk factors for humans? 1 thinl; 10 the record is very very clear as to what X said causes 11 risk factors, but I am willing, if the Court wishes, to 12 repeat the same list again. 13 Qi You needn't do that. We heard it once, 14 fc. Well, you asked the question a second time. 18 & It is pretty clear to say that certainly you couldn 16 blame any of those clefts before 1951 on Diazinon. 17 A. In the absence of an exposure to a teratogen, 18 you cannot blame the teratogen or incriminate the 19 teratogen for the birth defect. That is fairly obvious. 20 Ql And, Doctor, is that a yes answer or a no? 21 A. X have answered, I think, fairly simply. 22 Qi Can you blame pre-1951 birth defects, cleft palate, S C T frg 0 9 & 23 cleft lip, on Diazinon? 24 A. I have already said no. 28 Qi Thank you. 141 Or. Epstein - Cross c 1 A. For the reasons I have given. 2 Ql Where are Diazinon's fingerprints on the McConnell C 3 cleft? 4 A. There aren't any. in fact, the majority of 5 adverse effects in the environment, whether cancer or C 6 birth defects, or genetic abnormalities, there are no 7 pathognomic, or fingerprints to say this cancer is due < 8 to that chemical, or this birth defect is due to that 9 particular chemical. It is very very rare that you can 10 have -- you can state by looking at a particular cancer, c 11 or this or that, or birth defect, this is due to exposure 12 to that agent. 13 Ql You can't do that in this case either, can you? f 14 A. I just told you. 15 Ql You said that in part you relied upon what you ( 16 perceived to be an absence of exposure in Diane McConnell * 9 17 to known teratogens, is that correct? I 18 A. Yes. l 19 Q. Well, I think in your earlier testimony, and I know JAVONNI, 20 you will correct me if I am wrong here, but, you led me 21 to believe that certainly almost no compound can be 22 excluded simply because there is no data, on it, is that 23 correct? N C lQ 24 A. Yes, certainly. There is a great deal of differenc 25 between actual data showing that a material is i * CO CJ ! 142 Dr. Epstein - Cross 1 teratogenic than the absence of data which would not 2 allow you to pass an opinion one way or another. But C 3 here we have clearcut exposure to an agent which has 4 been demonstrated to be teratogenic in several animal 5 species and several strains. We don't have data on r 6 teratogenicity of any other materials to which she was 7 exposed. <8 Now, I am not willing to exclude the 9 possibility that there were other materials in the 10 environment. I don't know. I am not prescient. All 11 I can do is to offer the Court an opinion based on the 12 evidence that is available. c Now, if you hypothesize on something 14 on which I have no data, I am not in a position to M *f` 'K M IV l 15 be helpful to you. * 16 Ql Did you give Diane McConnell a checklist of S 17 possible teratogens so you can know this? k 18 A I gave her nothing. I have never met Mrs. isi McConnell until this morning, but I asked Mr. Bolden I 20 if he would please inquire into a range of exposures 21 and factors. 22 Q. Hr. Bolden did this for you? Q VnZG Q Z 23 a. I asked Mr. Bolden if he would get this information l 24 for me, and make this information available to me. 25 Q, What checklist did you give him to find out what ( 143 Dr. Epstein - Cross the exposure to other-- A. I have already told you that -- Qt You gave him that checklist? A. Would you allow me to finish before firing staccato questions? I told Mr. Bolden that I needed informa tion covering a wide-range of factors, including any drugs she took in pregnancy, tobacco, alcohol; I went into a very wide-range of possible environmental influences with Mr. Bolden and I got information on all of those. I got information on drugs, lack of radiation -- Ql Doctor -- A. -- alcohol, tobacco, and all otherexposures. So, the answer to your question is, while I do not have a formal checklist in front of me of factors one to twelve, I inquired about all factors which I considered. Qi Okay. Well, Doctor, ifsomething werecarcinogenic, would you -- that means it causes cancer. Maybe we are bandying about words here that not everyone is totally ; familiar with. Doesn't it, carcinogenic means capable of causing cancer? A. That's right. Qi If you suspected a compound as being carcinogenic. 144 c Dr. Epstein - Cross 1 would you also have suspicions about its teratogenicity'1 2 A. Well, that is a good question. One of the * 3 difficulties of answering this is that we don't have 4 good comparative data on a large number of carcinogens 5 and a large number of teratogens. There have been 6 suggestions based on smaller numbers that there is an 7 association between the two. I don't think the t 8 association is an obligate one. I don't think it is a 9 very clearcut association. But, there are some sugges 10 tions of an association. 11 It is clear that some carcinogens do 12 induce teratogenic effects. But, that doesn't mean to 13 say that there is a close association between them. 4 .14 Ql There is a lack of -- 15 ft 16 17 THE COURT: Just a moment, Mr. McCandless May I see counsel at side bar, please? (Side bar discussion on the record, 18 as follows:) 19 THE COURT: I don't want to limit .anybody 20 By the same token, I don't want to cause unnecessary 21 expense. But, I do not want to press the jury too hard. 22 We have pushed them pretty hard. 23 C 24 I take it you are going to be awhile? MR. McCANDLESS: I may well be. W 25 THE COURT: Particularly if you are goinc ( H M ty f* . H M M , ||T * * V**1* ,U z fc T t^ e o r 145 Dr. Epsteitt - Cross 1 to go over the same ground Mr. Griffin has already 2 covered. V3 MR. McCANDLESS: I don't think I have 4 done too much of that already, have I? 5 THE COURT: It all depends if 80 percent 6 of what you have done is too much or not too much. 7 In any event, I certainly am not going 8 to cut anybody off. But, I am not going to push the 9 jury any further. It is now 4:15. They have been 10 sitting without a break for two hours. I am going to 11 excuse them until 9:30. 12 Unless -- if I knew -- Mr. Griffin. c 13 If I knew that five or ten minutes 14 more would save a witness fee, I will -- but I -- 15 MR. FERRONI: Your Honor, the witness < 16 does have a plane that he would like to catch at 17 7 o'clock tonight. with all due respect to the Court, 18 if we could finish today, we would appreciate it. 19 THE COURT: Yes. But, you would have - < >' N N > V > *(. Hi. f t t 20924143 20 to say, with all due respect to defense counsel, and 21 defense counsel are not about to accommodate this 22 witness, I don't think. 23 L 24 Am I correct in my assessment? MR. McCANDLESS: Yes, your Honor. 25 I think you are right. ( 146 Dr. Epstein - Cross MR. SPALDING: Perhaps we could inquire of the jury if they would be willing to indulge us to hear the end of this witness' testimony. 147 ? 1 (Proceedings for December 10, 1982.) 2 (Court convened at 9:55 a.m.) 3 THE COURT: Good morning. 4 The witness may return to the stand. 5 * 6 -(Dr. Samuel Epstein resumed the witness 7 stand.) 8 CROSS-EXAMINATION(Continued) 9 BY MR. McCANDLESS: 10 Q. Good morning. Doctor. l 11 A Good morning. 12 Qi Did you meet with plaintiffs' counsel last night? 13 A Well, we had dinner yesterday together, yes. 4 14 Ql Did you discuss this case? 15 A No. No. 4 16 Qi Not at all? *to !to 17 A No. We talked about music and many other matters, 18 but not the case. l 19 MR. McCANDLESS: Your Honor, I would lik e 20 to make a motion about this witness. I feel that during 1 21 22 THE COURT: Come to side bar. 23 (Side bar discussion on the record as i 24 follows:) 25 MR. McCANDLESS: Your Honor, I think tha t 4 149 Or. Epstein - Cross e 1 the key words, like diazinon,_or whatever you are 2 interested in, and they produce the information for 3 you. 4 ft Mr. Bolden supplied you with this literature. 5 A. Yes. 6 ft In your deposition which we took in Chicago in 7 August of 1981, you said that you had only been asked 8 to consult in this case some five months before the 9 deposition. 10 A That was a mistake. It was in fact the summer 11 of 1980. 12 ft We did come to Chicago to depose you; you recall 13 that? C 14 A Yes, I do. 15 ft And, you charged us a thousand dollars for your 4 16 time on that single day, isn't that right? 17 A Yes, that's correct. 18 ft And, that time, as now, you presented yourself as 19 being an expert in reading literature, is that correct? 20 A That was not the language I used. I presented e r 21 myself as an expert in toxicology. 22 ft And at that time you read the 1974 Baselt Rat 23 Study backwards, did you? i 24 A Yes. In fact, I got the Baselt report fairly 25 shortly before the deposition, and I really hadn't had m iiu i, au. fi*'* la 1 150 Dr. Epstein - Cross 4 i an adequate amount of time to look into it as thoroughly 2 as I did subsequently. I think I pointed out right 3 . at the beginning of the deposition that I had by no 4 means completed my literature review. 5 ft But, at that time, your conclusion was that that 6 showed some sort of teratogenic effect. 7 A. That's correct. 8 ft And it in fact didn't. 9 A. Well, I wouldn't say it is totally without any 10 effect at all. But, there is no question that I t 11 misread one table. However, there are certainly some 12 other interesting aspects to the Ciba-Geigy 1974 report. 13 which make it not entirely without blemish. l 14 ft But now you changed on your chart from a plus to 15 a minus? 16 A. That's right, yes. 5*k 1 17 ft Doctor, in the request that was presented to you m 18 about this case, were you asked to find the cause ( 9 19 for the birth defect, or were you asked whether Diazinon w 9 m a 20 was involved? \ 21 A. 1 was just asked to review the files and to see if s 22 I could come up with an opinion as to the causes of the 23 birth defect. fK 24 ft And, Diazinon had been suggested to you, hadn't it? 25 A. 1 was presented with a background document and I 151 Or. Epstein - Cross 1 asked to review them and asked to see if I could come 2 up with an opinion. 3 ft Diazinon was suggested to you at that time. 4 A. Well, to be quite frank with you, I don't remember 6 exactly the nature of the original letters and the 6 conversation, but I was told, among other things, that 7 she had been exposed to pesticides in her early 8 pregnancy, yes. 9Q 10 A. You have the original letter with you, don't you? I am afraid I don't, no. 152 Or. Epstein - Cross 1 A. Well, I specifically inquired about all these 2' matters, and you are quite right in pointing direction 3 in those areas. 4 First of all, as far as tobacco is S concerned, she did smoke certainly at one stage, but 6 she gave up smoking as soon as she discovered she was 7 pregnant. I believe that was the exact time. 8 Over and above that, she did take 9 alcohol very very briefly. I think over Christmas 10 when she was pregnant. She said that she had taken, 11 I believe, one to two glasses, or something of that 12 kind. So, in fact, she didn't take alcohol during 13 pregnancy, with the exception of about one to two 14 glasses of alcohol in Christmas of '78. And, as I 15 said before, she stopped smoking as soon as she 16 discovered she was pregnant with Kristine. 17 Q, Isn't that somewhat contradicted by the medical 18 records you were given on this lady's delivery and her 19 health before that time wherein it was indicated that 20 she was smoking one-pack-and-a-half a day? 21 A You are absolutely right. There is one record of 22 Dr. nayman, in which it was said that she smoked one- 23 and-a-half packs a day. And I specifically inquired 24 about that and was assured by Mr. Bolden, who in fact 25 I asked him to go back and check with Mrs. McConnell, 153 Dr. Epstein Cross t 1 that in fact that represented her past history, that 2 she had in the past smoked one-and-a-half packs of 3 cigarettes a day in her pregnancy, but that in fact she 4 confirmed to me, via Mr. Bolden, that she did not 5 smoke during this pregnancy. r6 In fact, in all the medical records I 7 saw, there was only one reference to her smoking in 8 pregnancy, and that was Doctor -- to the best of my 9 recollection, that was Dr. Hayman's note, which I am 10 assured is a mistake. 11 Q. Doctor, have you brought all the records with you? 12 A. No, I don't have the medical records. 13 & Did you ever talk to Mrs. McConnell personally? ( 14 A. Yes, I spoke to her yesterday and introduced myself 18 and asked to see her daughter, and that is the first ^ Ml MU M 16 time I have spoken to her or seen her. 17 Qt Doctor, I realize you are not what you call a 18 bench teratologist, but you agree that in the field 19 of teratology there is a wide margin of error when you " M - 20 ask a mother what it was she might have been exposed to 21 after delivery? \ I 22 A. You are absolutely right. Human memory is, mine 23 included, is frail at best. And, one can simply go on w l 24 good faith. 25 If indeed you question and question u\ 154 Dr. Epstein - Cross f i repeatedly and repeatedly and you get an answer, "I 2 haven't smoked," or, "I didn't take alcohol," you know, r 3 what else can one do but accept. 4 I am not denying the possibility that 5 an error was made, but all I can say is, I don't think r 6 so. 7 Now, if you ask me the basis for saying, t 8 "I don't think so," I can't really tell you. It is 9 just my feeling that this is the truth. 10 Qi Well, then, you are familiar, I take it, with the 11 literature of people who are bench teratologists, that 12 there is certainly a selective memory bias in women 13 who have had children with birth defects as to what c 14 they have been exposed to during pregnancy. 15 A. With due respect, I don't think bench teratologists 4 16 would have any information at all on this. A bench 17 teratologist is someone who works experimentally with 18 animals and most of them have never seen a pregnant 18 woman, let alone -- in the course of their professional 20 activities -- let alone have any professional opinion 21 on this. , 22 The kind of person who I think would 23 be qualified in this area would be, say, the clinical l 24 -- the clinical teratologist, or the pediatric teratolo 25 gist on the one hand; alternatively, the psychiatrist. mi mw * m Z 9 X IZ C 0 Z 1 161 Dr. Epstein - Cross 1 the mothers showed. 2 Q. Two-out-of-five of them died. 3 A. Yes, there was weight loss and mortality, sure. 4& Under current teratological practice, with the 5 bench people now, as you understand it, don't the % 6 scientists in that field now regard that type of test 7 as not showing teratogenic effects because you are 8 inducing toxic effects in the mother? 9 A. No. In any teratology experiment you aim to give 10 a series of doses, the top dose being -- the highest 11 dose being a near-toxic-dose, or just short of toxic. 12 very often called MTD, or Maximally Tolerated Dose. H U M . m ill, IJ. I , i fM I4| 6sm 608 13 That is standard practice. 14 Then you give fractions of those doses. IS So, it is standard practice, as I said, to have in your * 16 high dose, as I said before, doses which approach * i toxicity. - 18 t In fact, in the Ciba-Geigy 1981 Study, i 19 they had mortality at the high dose and they had also H ! 3 20 symptoms at the high dose, and I wouldn't criticize S 21 the Ciba-Geigy Study on that basis. I think it is a s 22 correct and proper approach. 23 & I am not criticizing the Study. I am asking you C 24 whether under current teratological practice, in the 25 experimental fields of teratology, isn't it true that ( m 162 Dr. Epstein - Cross 1 teratologists would tend to ignore any findings where 2 they have shown toxic doses in the mother? 3 A. 4 ft No. She just showed toxicity. 5 A. The answer is no. One wouldn't ignore them. One 6 would weigh those findings accordingly, 7 ft But, they are not of value, or the same value as * 8 compared to an effect shown at a subtoxic dose? 9 A. As I said, one would wait until those data are 10 recorded. % 11 ft What weight would you put on it? 12 A One would not ignore them, but one would note C 13 that there is toxicity. But, toxicity alone -- hundreds 4 14 and thousands of chemicals are toxic, but hundreds and 15 thousands of chemicals are not teratogenic. So, there 4 16 fore, toxicity per se does not confer teratogenicity. * i 17 That is exactly what I mean by -- I am saying, one would 18 weigh those observations accordingly, K 44 19 ft You would give it less Weight? i s 3 20 A I would certainly give it less weight, yes, but I 4 21 would not ignore it. ` 22 ft Okay. And, that one -- this dilated renal pelvis, 23 shown in Kimbrough and Gaines, under current practice in K C 1w 24 teratology, when you are dealing with rats, isn't it >* H* cr25 true that that is regarded not as a birth defect, not as c i 163 Dr. Epstein - Cross 1 a teratological effect, but something that is seen in 2 the normal development of rats, and depending upon 3 when you take your sample you may well it, you may well 4 not? 5 A. Oh, certainly. But, it is regarded as a birth 6 defect. Developmental abnormalities are birth defects. 7 For instance, a cleft lip and a cleft 8 palate, I presume you would regard as birth defect. 9 Ql Well -- 10 A. But, they are -- they occur at a stage in preg 11 nancy that the palate and the lip haven't fused. So, 12 therefore, one can't say because that is just simply 13 developmental, therefore, it isn't a birth defect. It c 14 is a birth defect. M . N U fW 15 Ql Well, these rats weren't born, were they, in ( 16 Kimbrough and Gaines. 17 A. No. The standard practice in most teratological 18 experiments is to deliver the young by cesarean section, 19 the test in the control before birth. 20 Ql And, you disagree with me then, I take it, that I.. \ 21 under current practice in the field of teratology, in 22 experimental teratology, teratologists would not regard 23 a dilated renal pelvis as being a teratological effect. 2 CJ 24 A I beg your pardon? I am sorry, I was just looking n 25 at something else. Would you mind repeating that? 164 Dr. Epstein - Cross 1 Ql Then I take it that you disagree under normal 2 present teratological science in the field of experiment al 3 teratology, that scientists who found dilated renal 4 pelvis, hydroureter in a rat, would not accept that as 5 being a teratological effect. 6 A. No, I think those are teratological effects. 7 Qi You think they are. % 8 A. Yes. 9 Ql And you think that is the general opinion in the 10 field? * 11 A That is what the authors of the Study considered, 12 and there are numerous statements in the literature 4 13 attesting to the fact.that on the basis of the Study 14 Diazinon is teratogenic. 15 Qi Kimbrough and Gaines concluded with a certain 18 qualification, didn't they? 17 A Certainly. 18 Ql They qualified any finding they might have found 1 19 by saying that it only occurred at toxic level doses? 20 A Well, that is not entirely true. I share the 21 qualifications of Kimbrough and Gaines, that the Study 22 is not a perfect one, and I pointed that out very 23 clearly and very explicitly in the deposition, that t 24 there are criticisms that can be made against the 25 Kimbrough and Gaines Study. However, it is incorrect 20324162 TH ** * ^ f H N C 165 Or. Epstein - Cross 1 to state that the birth defects were only noted at the 2 highest dose level. In fact, as I indicated before, 3 birth defects were noted at the lowest dose level of 4 100 mg per kg where there was no evidence of toxicity 5 at all. And, I explained that very clearly to you 8 before when I said at the 100 milligram per kg dose, 7 that birth defects were noted. 8 Qi Doctor, I would like to read to you from the li 166 Dr. Enstein Cross t 1 178 1 Dr. Epstein - Cross MR. McCANDLESS: Your Honor, I would - 2 ask to terminate this answer. 3 He originally stated -- 4A It is a scientifically precise -- S THE COURT: Mr. McCandless, when you 6 ask questions like that, you encourage answers like this. 7 t8 MR. MCCANDLESS: I got an answer. THE COURT: None of which has anything 9 to do with the issues before this jury.- 10 MR. McCANDLESS: I understand that. t 11 I was about to ask -- 12 THE COURT: So, if you will go on to 1 13 the next question and avoid that kind of question we 14 won't have to listen to these extended lectures. 15 MR. McCANDLESS: Yes, your Honor. I c 16 thought we had received an answer when he said he ts i 17 didn't know what I meant. But then somehow from not 18 knowing we appeared to be going down the road. ifs 19 BY MR. MCCANDLESS: sm 3 20 Ql Okay, Doctor, that's all I have. Thank you. ia 21 A Thank you. 3M* 22 MR. BOLDEN:. May I have a moment, your l 23 Honor? )24 (Pause o % 25 (Off-the-record discussion among <1 (X 1 179 Dr. Epstein - Cross 1 plaintiffs' counsel.) 2 HR. BOLDEN: No questions, your Honor. f3 THE COURT: You may step down. Doctor. 4 MR. GRIFFIN: If your Honor please, 5 based on the examination by Mr. McCandless, I have * 6 just a couple of questions. 7 THE COURT: All right. 8 MR. BOLDEN: I will object to that, 9 your Honor. 10 THE COURT: No. He has a right to 11 cross-examine further after the other cross-examination, 12 if he wishes. 13 * MR. GRIFFIN: I think it will be very 14 short, your Honor. . r N I 9HH 15 FURTHER CROSS-EXAMINATION ( 16 BY MR. GRIFFIN: 17 QL Dr. Epstein, in answer to some questions Mr. 18 McCandless asked you, you said Ciba had patented 19 Diazinon back in the mid-fifties. M M W - . NVM 1 HJ. 20 A Well, it may be a mistake. They developed it. 21 They developed it right about '51 and marketed it arouac 22 about '54. But -- 2032417 i 23 Qi Well, you know if there was a patent, it only 24 lasts for 17 years anyhow, don't you? 25 A Yes. **1 180 ' Or. Epstein - Cross ft So, that by the mid-seventies, this was 'a product that could be produced around the world without any limitations by anybody who wanted to produce it. A. I take your word for that. Ci Now, Doctor, I have had a chance over the evening to look at those other references you have. And, if there is anything in there you really think is important I don't want to hold you back from telling the jury about it. A Well, I don't want to be -- THE COURT: He has now withdraw his objection to your reference to the -- is it the subse quent studies and articles? MR. GRIFFIN: Yes, sir. He had three references yesterday I knew nothing about, and over the evening I was able to look at them, and if the Doctor thinks they are important and the jury should know about them, you can tell them. MR. BOLDEN: I think that is unfair. We were not permitted to question the witness in direct examination about them. THE COURT: You will have full opportu nity . If you wish now to inquire, I will do that before he resumes his cross-examination.  t i 9 i i. *S sm : tlO c i 181 1 Dr. Epstein - Cross MR. BOLDEN: No, your Honor. I think 2 it is probably best if Dr. Epstein wants to refer to 3 it, to let Mr. Griffin conduct the examination. 4 THE COURT: All right, you may bring 8 it out and you may, in your redirect examination, which 6 you have a full right to do, then explore it as fully 7 as you wish. 8 Mr. Griffin, you may proceed. 9 BY MR. GRIFFIN: 10 Ql Doctor, I can just short cut it, Doctor, by saying, 11 you had three additional references. One had to do with 12 egg and chick studies, didn't it? 13 A Are we talking about one chart, or all my charts? 14 Are you withdrawing your objection to all my charts, 15 or are you being selective about what I can -- 16 Qi I was talking about the literature references. 17 That is the only thing I have been able to check. 18 A Hell, there are several literature references, 19 and essentially what are you saying, that I can refer 20 to all three charts, or would you like me to be 21 selective about my suppression of information? 22 Ql I may have misunderstood you. I only thought there 23 was three additional literature sources to which you 24 went in making up the chart. 28 A In one particular chart, on the chart on the S LY vZS O Z  132 Or. Epstein - Cross 1 teratogenicity of Diazinon, that is true. There are 2 however, also statements on quotations from the %3 literature on precautions to be taken with Oiazinon and 4 persistence with Diazinon, and quotations si the 5 literature on teratogenicity of Diazinon. 6 Now, essentially what are you telling 7 me you want me to do? Should 1 suppress some informatic n / t 8 all information or no information? 9 Cl Doctor, I simply want to give you a chance to tell uI 189 Or. Epstein - Cross < 1 A. Well, would you let me finish and then I -- 2 Qi I want to know whether you did. t 3 A. Yes. I will be very happy to respond to any 4 questions if you will allow me to finish. 5 Qi Go on. 6 A. Menzie, 1969, United States Department of 7 Interior, quotation: "Diazinon half-life varies from < 8 21.6 to 80.2 days." 9 Now, what this amounts to -- let me 10 explain,if I may, what a half-life means. A half-life I 11 is the standard way of expressing the time taken for 12 material to degrade and to disappear. ( 13 If you say the half-life of a chemical v 14 say, in soil, is four days, it means by four days 15 50 percent of that chemical will have disappeared, okay? < 16 Four days after that, another 50 percent would have tm m 17 disappeared. So, in other words, by eight days there i 18 would only be 25 percent of the original. So, half-life < 19 is an expression of how long it takes for half the stuff M n H il, N4. 20 to disappear. < 21 Now, in soil, the half-life of Diazinon 22 can extend up to nearly three months. C CJ to 23 Now, take into account that in soil you i H- 24 have air movement, constant air movement; wind, sun, 9 25 rain and bacteria that are breaking down the Diazinon. K  * * * i I ( ( ( i 190 Dr. Epstein - Cross t Very very different from the situation in a house, or 2 in a carpet where you don't have constant wind movement, 3 air movement; you don't have constant wind, you don't 4 have constant sun, you don't have light, you don't have 5 bacteria which break the stuff down. 6 So, the statement already -- by 1969 7 it was known that Diazinon was a relatively stable 8 material, that it could vary up to three -- almost three 9 months, eight days. By eighty days, only half the stuff 10 would have disappeared. Okay. 11 Mow, let's see what the industry says 12 about Diazinon -- about exposure to Diazinon. This is 13 a statement from a book by Cornwell, a British textbook 14 by a manufacturer, director of a pesticide group known 15 as Rentokil. And it says, "...inhalation should be 16 prevented in confined areas." 17 The next, Ciba-Geigy, 1975; the 18 literature of Ciba-Geigy. "Do not breathe spray mist. 19 Do not get in eyes or skin or clothing." "One half of 20 the original application (in soil) was lost in two to 21 four weeks." Now, this is quite interesting. 22 Ciba-Geigy, in 1975 says, about two 23 to four weeks, up to four weeks, the half-life of 24 Diazinon is up to four weeks. It is interesting that 25 the same Ciba-Geigy statement that says that, also has M C CO tS K" 05 05 191 Dr. Epstein - Cross 1 a reference to the authority on which this is based. 2 This statement is based on an author known as 3 Braugh Rasmussen, which is cited in the Ciba-Geigy 4 document. But, Ciba-Geigy states that one-half was 5 lost in two to four weeks. It doesn't say one-half 6 was lost in eighty days. But, be that as it may -- 7 even though the Ciba-Geigy document says that, half 8 the stuff can remain after four weeks, okay. 9 The Environmental Protection Agency, 10 Allison and Hermanutz. What do they say? This is a 11 study in water. "Diazinon may persist many months in 12 some fresh water environments." Again, with exposure 13 to air, to sun, constant air movement; not just a 10 14 or 20 percent loss, or what have you, but constant air 15 movements, bacteria even can exist for many months. ( 16 Now, the United States Army, in Port < 17 Detrick, the Center for Bacteriological Warfare Research 18 -- and, there is a paper in 1978 by a man called Meier, 19 who determined that there was an impurity in Diazinon, 20 a highly toxic impurity known as sulfotep, which is 21 highly persistent, very stable and highly toxic, and he1 22 noted that this information was known to Ciba-Geigy and esT^zeoZ 23 that Ciba-Geigy had failed to warn people on its label, l 24 and had failed to produce any information in the open 25 scientific literature, or its own literature on sulfotep, * 192 Dr. Epstein - Cross 1 it's highly toxic, highly persistent impurity. And, 2 I quote, "Sulfotep is an impurity common to all 3 formulations. It is much more toxic. It is not more 4 stable. It may concentrate. Sulfotep presents a 5 % previously unidentified potential hazard to health.." 6 No warning by Ciba in its literature, no reference in 7 the total scientific literature. *8 NIOSH, 1978, National Institute of 9 Occupational Safety and Health, 1978: "Diazinon can 10 be considered to be possibly teratogenic and should be 11 handled with caution by women of childbearing age." 12 Baselt, in 1978. Dr. Baselt is the 13 Connecticut Medical Examiner who, I don't know, but I 14 am told has extensive experience in poisonings and 15 pesticides and other agents: "Diazinon itself " ( 16 and I quote, "-- accumulates in fat at concentrations * 8 3 17 over 100 times those in blood." 18 So, in other words, even when you look * 19 in blood, say about a few days afterwards, a few days a s i 20 after a pesticide spraying, you find no diazinon in 3 21 the blood, but, it is accumulated in the fat. 20324190 22 And, he goes on to point out that a ( 23 particular breakdown product, some breakdown products 24 of Diazinon, which I will tell you what they chemical 25 is, but it doesn't make any difference -- 1 20924191 qcaaq xaxxaqam ssop 'ou5[ oq spaau auo 'pauasouoo sz st aansodxa uo uoTqsmaojuT sc stsj sy aansodxa uo uoxqcuuo^uT st puooas aqq lAqxoxua6oqe;iaq ic^uauixjadxa aqq sen a zz ' asco sxqq ux qoxqM 'xaxaaqem aqq 30 Aqxoxxoq quaaaqux aqq uo uoxqamaojux 'auo *uox^cmaojux 50 saoaxd on^. iz 0z 3Acq oq spaau auo 'qoajja asasApe Auc jo sxsAxaua ua 61 'sxux 'aaojaq paqeoxpux I sc asodand aqj, :6uxmoxioj 81 aqq sx Axdrnxs AaaA asodand aqq quxqq 1 *on y Li caqxD qa pan AanC aqq qa oq qaqq 50 91 asodand aqq sx 'sn uaAtfi aAaq noA qaqq sxaqax aqq XT SI uo qxaq aqq se jcj sa 'noN *aoqooa 'qqfix^ XIY tJ l am aAafi no& Cl Aqxunqaoddo aqaxaaadda 1 *noA quaqj; Zl poq aqq ux uouxzaxa 30 saqxxoqaqam aqeaqsuomap 11 ueo noA aansodxa aaqja sqquom o/nq se 5uox sa usab pua 01 'qcj aqq ux sqsxsaad uouxzcxa aqq qaqq suxamaj qocj 6 aqq 'qng `saqxxoqaqam aqq 30 amos 50 Aqx=>Xua6oqajaq 8 aqq uo uoxqamao3UX ou ssoaoa amoo aAaq 1 -oxuafe L -oqeaaq aaa saqxioqaqaui asaqq 50 qoxq* jo 'saqxToqsqam 9 asaqq 30 Auam Aoq Mouq q,uop 1 'mon S poq aqq ux uouxzaxa aqq 30 saqxxoqaqam pux3 * IXX^s Pinoo noA aansodxa aaqje sqquom OAq 'os `aansodxa aaqja s/ap 8S Pu ZZ paqoaxioo suamxoads auxan ux puno3 C z ajan saqxxoqaqam aqq 'pua -- pxoa oxaoqdsoqdx^qqaXP ssoao uxaqsda *za E6T l itn iu i, m . it rM im l > ? ) '1 > ) J > 194 Dr. Epstein - Cross f 1 down immediately; is it persistent; does it degrade, 2 and information of this kind. And, this, I submit, is < 3 highly relevant to the question of the persistence 4 and exposure. 5 Now, I am sorry if you take a different (' 6 opinion, but in my view this is critical to an analysis 7 of the problem. ( 8 Ql Let me just ask you: This case doesn't involve 9 in any way Diazinon in the soil, does it? 10 A Certainly not. But, Diazinon in the soil breaks ( 11 down -- 12 Ql Excuse me. Doctor ~ t 13 A Excuse me. Diazinon in the soil breaks down -- 14 Qi Doctor -- 15 THE COURT: Dr. Epstein -- (. 16 THE WITNESS: I am sorry. Iffc a 17 Ql Just answer my question and we will get over this : 18 quickly. This case doesn't involve Diazinon in the I iU 19 soil. m S 20 A Correct. ( 21 Qi This case does not involve Diazinon in water. . 8 22 A Correct. 23 Ql Did you make any searches through the literature 24 to see what the breakdown of Diazinon would be in the 25 environment that we are talking about? i GTVZGQZ 195 A. Dr. Epstein - Cross To be quite frank, this is an issue that came -- that arose -- Qt Did you make any searches to see -- A. No. This is an issue that only arose relatively recently. I had already -- at the time of i nr