1 1 NO. 90-CI-06033 JEFFERSON CIRCUIT COURT DIVISION ONE 2 3 4 JOYCE FENTRESS, et al PLAINTIFFS 5 6 VS TRANSCRIPT_OF_THE_PROCEEDINGS __________ __ ___ ___________ 7 8 9 SHEA COMMUNICATIONS, et al DEFENDANTS 10 11 *** 12 13 14 WEDNESDAY, OCTOBER 12, 1994 15 VOLUME XIII 16 17 * * * 18 19 20 _____________________________________________________________ 21 REPORTER: JULIA K. McBRIDE Coulter, Shay, McBride & Rice 22 1221 Starks Building 455 South Fourth Avenue 23 Louisville, Kentucky 40202 (502) 582-1627 24 FAX: (502) 587-6299 25 2 1 2 I_N_D_E_X _ _ _ _ _ 3 4 WITNESS: DOCTOR_DOROTHY_DOBBS - By Deposition _______ ______ _______ _____ 5 Examination by Mr. Smith................................. 5 6 WITNESS: DOCTOR_HANS_WEBER - By Video Deposition _______ ______ ____ _____ 7 Examination by Mr. Smith................................. 90 8 * * * 9 Hearing in Chambers...................................... 90 10 * * * 11 WITNESS:__DOCTOR_HANS_WEBER - By Video Deposition (Cont'd) ________ ______ ____ _____ 12 Examination by Mr. Smith.................................105 13 * * * 14 Bench Discussion.........................................107 15 Reporter's Certificate...................................112 16 * * * 17 18 19 20 21 22 23 24 25 3 1 2 A_P_P_E_A_R_A_N_C_E_S _ _ _ _ _ _ _ _ _ _ _ 3 4 FOR THE PLAINTIFFS: 5 PAUL L. SMITH Suite 745 6 Campbell Center II 8150 North Central Expressway 7 Dallas, Texas 75206 8 IRVIN D. FOLEY Rubin, Hays & Foley 9 300 South, First Trust Centre Louisville, Kentucky 40202 10 11 FOR THE DEFENDANT: 12 EDWARD H. STOPHER Boehl, Stopher & Graves 13 2300 Providian Center Louisville, Kentucky 40202 14 JOE C. FREEMAN, JR. 15 LAWRENCE J. MYERS Freeman & Hawkins 16 4000 One Peachtree Center 303 Peachtree Street, N.E. 17 Atlanta, Georgia 30308 18 ALSO PRESENT: 19 DR. W. LEIGH THOMPSON 20 21 22 23 24 25 4 1 The Transcript of the Proceedings, taken before 2 The Honorable John Potter in the Multipurpose Courtroom, Old 3 Jail Office Building, Louisville, Kentucky, commencing on 4 Wednesday, October 12, 1994, at approximately 9:20 A.M., said 5 proceedings occurred as follows: 6 7 * * * 8 9 MR. SMITH: Your Honor, since the Court 10 Reporter is here, can I move into evidence those exhibits 11 offered in connection with Doctors Slater and Stark? 12 JUDGE POTTER: So what we're talking about is 13 exhibits -- actually, it's all Doctor Slater, I think, but 14 it's Depositions 42 through 50 are admitted -- or Exhibits 42 15 through 50. 16 SHERIFF CECIL: The jury is now entering. All 17 jurors are present. Court is in session. 18 JUDGE POTTER: Please be seated. 19 Mr. Smith, do you want to call your next 20 witness? 21 MR. SMITH: Yes, Your Honor. At this time we'd 22 request to read the written deposition of Doctor Dorothy 23 Dobbs, M.D. 24 JUDGE POTTER: Ladies and gentlemen, I'm going 25 to remind you again that this witness is being called by 5 1 deposition. Deposition testimony is sworn testimony. The 2 person is under oath just the way they are at trial when they 3 give the deposition, and every question that's asked and every 4 answer should be given the same weight and effect as you would 5 give the question and answer if it was asked here in the 6 courtroom, rather than asked, you know, a month or two ago 7 somewhere else and then read here. The person is under oath 8 and it has the same value. 9 Mr. Smith. 10 (MR. SMITH & MR. DOBIESZ READ THE FOLLIWNG 11 TESTIMONY FROM DOCTOR DOBBS' DEPOSITION) 12 MR. SMITH: This is the deposition of Doctor 13 Dorothy Dobbs taken on July 11th, 1994, beginning on Page 2: 14 Comes Doctor Dorothy Dobbs, called by the plaintiffs, and 15 after first being duly sworn was deposed and testified as 16 follows, beginning on Page 12, Line 20. 17 Doctor Dobbs, have you given a deposition 18 before? 19 A. Yes. 20 Q. On how many occasions have you given a 21 deposition? 22 A. Three or four. 23 Q. Have you testified as an expert as to FDA 24 regulatory issues? 25 A. Yes. 6 1 Q. When was the last time you testified as such an 2 expert? 3 A. In the late '60s. 4 Q. Is that when you were working for the FDA? 5 A. Yes. 6 Q. Were you testifying on behalf of the FDA? 7 A. Yes. 8 Q. When you were working with the FDA, did you ever 9 testify on behalf of a drug manufacturer? 10 A. No. 11 Q. When you say testified, did you testify at a 12 trial or did you testify, like, for Congress or congressional 13 subcommittees or something of that nature? 14 A. I wasn't including the two or three times that I 15 testified before congressional committees. The two that I had 16 in mind were hearings. 17 Q. When you testified before congressional 18 committees, were you an employee of the FDA? 19 A. Yes. 20 Q. How long were you at the FDA? 21 A. Approximately five years, although in the 22 interest of total accuracy, there was one period of about a 23 year when I was working part time at St. Elizabeth's and part 24 time at FDA, and then I returned to FDA full time. 25 Q. When did you first start working at the FDA? 7 1 A. I believe it was January 1965. 2 Q. Until about 1970? 3 A. Until the end of 1970. 4 Q. What did you do at the FDA? 5 A. Initially, I was a medical officer reviewing new 6 drug applications. I later transferred to the marketed 7 drug -- or actually it was called Division of Drug 8 Surveillance. And still later, with a reorganization, I 9 was -- no, prior to the reorganization I was Director of the 10 Division of Neuropharmacology for Drug Surveillance, that is 11 marketed drugs, and then, following a reorganization, was 12 Director of the Division of Neuropharmacologic Drug Products. 13 Q. Do you do any regulatory work now? 14 A. No. 15 Q. Either for a drug company or for a governmental 16 agency? 17 A. No. 18 Q. When was the last time you did regulatory work? 19 A. When I was at Lilly. 20 Q. When did you leave Lilly? 21 A. June 1985. 22 Q. Have you kept up with any of the changes in the 23 regulations or anything of that nature at the FDA? 24 A. No. 25 Q. Do you consider yourself at the present an 8 1 expert on regulatory compliance, FDA regulatory compliance? 2 A. Not now, no. 3 Q. When you say that your last position at the FDA 4 was as director of the Division of Neuropharmacological Drug 5 Products, would that be the same position that Paul Leber is 6 in now? 7 A. Yes. 8 Q. How long were you director of that division? 9 A. About six months. 10 Q. So from about the middle of 1970 to the end of 11 1970? 12 A. Approximately, uh-huh. 13 Q. Where did you go after leaving the FDA? 14 A. Abbott Laboratories, North Chicago, Illinois. 15 Q. Know it well. 16 A. Currently Abbott Park, Illinois. 17 Q. How long were you with Abbott? 18 A. Close to 11 years. 19 Q. Why did you leave the FDA? 20 A. The director of the Bureau of Medicine or Bureau 21 of Drugs -- I can't remember which it was called at that 22 time -- apparently felt that I was not a good manager and 23 asked me to take another position. 24 Q. Another position with the FDA? 25 A. Yes. 9 1 Q. Who was the director of Bureau of Drugs at that 2 time when you left? 3 A. Director Henry Simmons. 4 Q. Did he say in what way he felt you were not a 5 good manager? 6 A. I don't recall his exact comments. 7 Q. Did he ask you to take a particular other 8 position at the FDA? 9 A. He suggested that I head up FDA activities on 10 drug abuse. 11 Q. You didn't want to do that? 12 A. No. 13 Q. Why not? 14 A. I wasn't interested. 15 Q. Did he give you any other options within the FDA 16 besides that position? 17 A. No. 18 Q. What did you do when you were at Abbott? Just 19 generally. I don't want to know any compound or anything like 20 that. 21 A. I was medical director for corporate regulatory 22 affairs. 23 Q. Did you have any particular type of drug that 24 you worked on, like psychiatric drugs or things of that 25 nature? 10 1 A. No. I was involved with essentially a cross 2 section of Abbott Laboratories' products. 3 Q. When did you leave Abbott? 4 A. '82 -- '81. 5 Q. And then when you left Abbott you went to Lilly? 6 A. Yes. 7 Q. And you were with Lilly until June of '85, I 8 believe you said? 9 A. Yes. 10 Q. We'll get into what you did at Lilly in more 11 detail a little bit later, but why did you leave Lilly in June 12 of '85? 13 A. In general, I wasn't finding my role at Lilly 14 very satisfying. 15 Q. Can you expand on that a little bit? What was 16 it about your role at Lilly that wasn't satisfying? 17 A. The status of my position was not really as high 18 as had been the case at Abbott. There were also some personal 19 reasons having to do with family and so forth. 20 Q. What position were you hired in at at Lilly? 21 A. Medical Adviser Clinical Research and Regulatory 22 Affairs. 23 Q. Did that position change? I mean, did you get 24 another position or other responsibilities while you were at 25 Lilly or did that pretty much stay the same? 11 1 A. It pretty much stayed the same. 2 Q. Were you expecting to move up to a higher 3 position while you were at Lilly? 4 A. I had anticipated that, yes. 5 Q. What was it that made you anticipate that? 6 A. Conversations prior to my going to Lilly. 7 Q. Conversations with who? 8 A. Primarily, Doctor Charles Christensen. 9 Q. Was this when you were interviewing for the job? 10 A. Yes. 11 Q. What did Doctor Christensen say about your 12 advancement with the company? 13 A. I certainly can't quote him at this -- after 14 this length of time. I certainly had the impression that it 15 was highly likely that I would be promoted to a director 16 position. 17 Q. Did he give you a time period in which you might 18 be promoted? 19 A. No. 20 Q. Were you promised a promotion? 21 A. No. 22 Q. Were you fairly confident that you would be 23 promoted? 24 A. Yes. 25 Q. Did there come a time then that you realized 12 1 that you were not going to be promoted? 2 A. Yes. 3 Q. When was that? 4 A. I don't remember exactly. Perhaps five or six 5 months after I had been there. 6 Q. So I understand this, you accepted the job with 7 the understanding, at least in your mind, that you would 8 eventually be promoted to a director position; correct? 9 A. Yes. 10 Q. And then about six months after you started your 11 employment with Lilly, you came to the realization that you 12 would not be promoted; right? 13 A. Yes. 14 Q. What happened that made you believe that you 15 would not be promoted? 16 A. I don't remember in every detail, but there was 17 one conversation with Doctor Christensen. 18 Q. Did he tell you that you were not going to be 19 promoted? 20 A. Yes. 21 Q. Did he tell you why you were not going to be 22 promoted? 23 A. The only specific comment that I can recall was 24 that I called attention to problems without offering 25 solutions. 13 1 Q. Okay. Well, during the time you were at Lilly 2 after this, after you came to the realization that you were 3 not going to be promoted, do you recall anybody else at Lilly 4 that was either on your level or below you that was promoted 5 in a position that you thought you should have been promoted 6 to? 7 A. Doctor Zerbe was made director of the 8 neuropharmacology area. I didn't know -- I don't recall where 9 Doctor Zerbe had been working within Lilly. 10 Q. Was he under your supervision at all? 11 A. No. 12 Q. How about Max Talbott? When did Doctor Talbott 13 start working at Lilly, if you know? 14 A. About the same time I did. 15 Q. Were you his superior? 16 A. I beg your pardon? 17 Q. Were you Doctor Talbott's superior while you 18 were at Lilly? 19 A. No. 20 Q. Were you on an equal level? 21 A. Yes. 22 Q. Tell me what your responsibilities were when you 23 first started at Lilly. 24 A. In general, I was a liaison between the company 25 and the Food and Drug Administration on certain assigned 14 1 drugs. 2 Q. What drugs were those? 3 A. Fluoxetine was obviously one of them; nabilone 4 was another; pergolide was another. There were some other 5 investigational drugs, some of which were never pursued; among 6 the marketed drugs, the various insulin products. I saw some 7 of the records on Darvon, but for reasons related to my prior 8 position I could not appear before FDA, and did not, as I 9 recall, even sign correspondence on Darvon. 10 Q. Because of a perceived conflict of interest of 11 some sort? 12 A. Yes. I reviewed advertising, advised within the 13 company on regulatory matters. 14 Q. When you say you reviewed advertising, you mean 15 Lilly product advertising? 16 A. Yes. 17 Q. Did you work on fluoxetine the entire time you 18 were with Lilly in some capacity or another? 19 A. Yes. 20 Q. In your capacity as liaison between Lilly and 21 FDA, we know that you were responsible for submitting 22 correspondence and other various documents to the FDA through 23 your position. What other responsibilities did you have as 24 liaison? 25 A. There would be from time to time telephone calls 15 1 between various FDA personnel and myself, the contents of 2 which were of course shared with the relevant individuals at 3 Lilly. I arranged for a number of meetings at FDA. 4 Q. Anything else? 5 A. I reviewed the intended submissions, 6 occasionally had suggestions within the company for some 7 revision, and in the case of fluoxetine I was in charge of 8 preparing the New Drug Application. 9 Q. You have testified that you have voiced 10 criticisms to Doctor Christensen about records that were kept 11 at Wishard and records regarding the disposition of 12 investigational drugs, although you did not recall whether or 13 not those criticisms were directed towards fluoxetine. Do you 14 have or do you recall any criticisms that you had with the way 15 that Lilly was developing fluoxetine or testing fluoxetine or 16 anything with regards to the aspects of fluoxetine whatsoever? 17 A. I was concerned about the magnitude of studies 18 in Europe and our capacity to deal with the enormous amount of 19 incoming data. 20 Q. Anything else? 21 A. Not that I can recall now. 22 Q. Earlier you testified that you were concerned 23 about the magnitude of the studies in Europe and the firm's 24 capacity to deal with an enormous amount of incoming data; 25 correct? 16 1 A. Yes. 2 Q. And that's specifically on the fluoxetine 3 trials; correct? 4 A. Yes. 5 Q. What was it about Lilly's ability to deal with 6 the amount of data coming in from the foreign trials that 7 concerned you; for instance, not enough personnel, not enough 8 computer capacity, things of that nature? 9 A. I questioned whether we had enough personnel. 10 Q. My understanding is -- and I'm a little bit 11 confused on this, so bear with me, okay? My understanding is 12 that protocols that are run on studies done in the United 13 States were submitted to the FDA for approval before studies 14 could be conducted. 15 A. That isn't correct, or was not then. 16 Q. Okay. 17 A. With the exception of the very first study to be 18 conducted under a new IND. 19 Q. When you say the very first study, you mean the 20 very first study on humans? 21 A. That's correct. 22 Q. To your knowledge, was that protocol submitted 23 before you became employed by Lilly? 24 A. Yes. 25 Q. Aside from the very first protocol being 17 1 submitted for approval by the FDA, can you think of any other 2 reasons a protocol would have to be submitted to the FDA while 3 you were there at Lilly? 4 A. From time to time the FDA, for one reason or 5 another, would require submission of a specific protocol. In 6 addition, it was sometimes to the company's advantage to 7 submit a protocol for review and comment, particularly for 8 those multi-center studies that were deemed particularly 9 important. 10 Q. Like something that the company would be 11 thinking of using as a pivotal trial later on? 12 A. Correct. 13 Q. Are you familiar with Protocol 27 on fluoxetine? 14 A. I'm sure I was in the early 1980s, but I am not 15 now. 16 Q. Do you recall a multi-center study run on 17 fluoxetine comparing fluoxetine, placebo and imipramine? 18 A. I recall that there was such a study. 19 Q. Do you recall whether or not you submitted a 20 protocol for that study while you were working at Lilly? 21 A. I don't know whether that was submitted prior to 22 my going there or whether I submitted it. 23 Q. How about final reports on studies done outside 24 the United States? If Lilly runs a trial outside the United 25 States and the drug is sourced from within the United States, 18 1 did the FDA require that final reports on those studies be 2 submitted? 3 A. It's my recollection that the final report had 4 to be submitted regardless of the source, sourcing of 5 investigational drug, that is. 6 Q. Okay. So even if, for instance, the fluoxetine 7 used in the UK was manufactured in London, the final reports 8 on those studies would still have to be submitted to the FDA, 9 as far as you recall? 10 A. Yes. 11 Q. Let's go back a little bit. Can you give me 12 your educational background after high school? 13 A. My undergraduate education was at Duke 14 University, 1945 to 1948, B.S. Degree in chemistry; 1948 to 15 1950, M.S. Degree in biochemistry at Emory; 1952 to 1956, 16 medical school, George Washington University in Washington, 17 minus the sophomore year, which I took at Emory. 18 Q. So you went back to Emory for your sophomore 19 year? 20 A. Yes. 21 Q. I'm sorry. Go ahead. 22 A. Rotating internship at St. Elizabeth's Hospital, 23 July '56, end of June of '57; residency in psychiatry at Duke 24 University in 1957 to 1960, and the last four months of my 25 residency back at St. Elizabeth's; that would have been 19 1 July 1, 1960, to the end of October of 1960. 2 Q. Okay. Any other graduate degrees that you 3 received besides your M.D.? 4 A. Well, Master's. 5 Q. Any others besides that? 6 A. No. 7 Q. What did you do after you completed your 8 residency in October of 1960? 9 A. I was appointed to the staff at St. Elizabeth's, 10 assigned to maximum security -- 11 Q. How long did you do that? 12 A. -- and later was made assistant chief, maximum 13 security. Until the end of 1964. 14 Q. And then you went to the FDA? 15 A. That's right. 16 Q. Are you board certified? 17 A. Yes. 18 Q. When were you board certified? 19 A. Roughly, 1963. 20 Q. In what specialty? 21 A. Well, the board is the American Board of 22 Psychiatry and Neurology. I was certified in psychiatry. 23 Q. Have you ever practiced as a neurologist? 24 A. No. 25 Q. While you were at St. Elizabeth's Hospital, did 20 1 you ever conduct clinical trials on psychotropic drugs? 2 A. No. 3 Q. Since you left Lilly, what have you been doing 4 employmentwise? 5 A. Starting in June 1985, I went to work as a staff 6 psychiatrist at Anneewakee, and I'll go ahead and spell that, 7 A-N-N-E-E-W-A-K-E-E. Anneewakee was a residential treatment 8 center for adolescent patients. 9 Q. How long were you there? 10 A. Until January 1987. 11 Q. And what did you do after that? 12 A. There was a brief period when I was not working; 13 my mother was terminally ill. On April 1st, 1987, I went to 14 work at Brynn Marr, B-R-Y-N-N, M-A-R-R, Hospital in 15 Jacksonville, North Carolina, working primarily, but not 16 exclusively, in the adolescent area which I later headed up. 17 Q. Any other positions that you held in the times 18 you took off from working at Brynn Marr Hospital? 19 A. No. 20 Q. What did you do after that? 21 A. I retired. 22 Q. Are you currently retired? 23 A. No. 24 Q. How long were you retired? 25 A. Until February 21st of this year. 21 1 Q. And now what are you doing? 2 A. I'm working part time as a psychiatrist at 3 Graydon Manor, G-R-A-Y-D-O-N, in Leesburg, Virginia. 4 Q. And have you been working part time at Graydon 5 since February 21st of '94? 6 A. Yes. 7 Q. Any other positions that you currently hold? 8 A. No. Let me go back a moment, again, in the 9 interest of total accuracy. During the time that I was 10 retired, I saw an occasional patient, including the young lady 11 I mentioned who was studying to be a court reporter, and did 12 some consulting work on one occasion that related to the 13 deposition that I previously mentioned in earlier testimony. 14 Q. Throughout your practice, Doctor, have you ever 15 prescribed Prozac to your patients? 16 A. Yes. 17 Q. On how many occasions would you say you 18 prescribed Prozac? 19 A. Perhaps 12, 15. I don't know exactly. 20 Q. Less than 20? 21 A. Yes. I believe so. 22 Q. Have you prescribed Prozac to adolescents? 23 A. Yes. 24 Q. On how many occasions? 25 A. Perhaps five or six, most of whom were already 22 1 receiving Prozac on the order of a physician who was 2 responsible for that particular patient prior to transfer of 3 responsibilities. 4 Q. Do you feel comfortable prescribing Prozac to 5 adolescents? 6 A. Yes. 7 Q. Have you ever had a patient who has experienced 8 an adverse reaction on Prozac? 9 A. Not of any clinical importance. 10 Q. Have you prescribed other medications 11 concomitantly with Prozac to those people that you prescribed 12 Prozac to? 13 A. Yes. 14 Q. What types of medications? 15 A. An antipsychotic. Otherwise, I don't offhand 16 recall. 17 Q. What prompted you to prescribe a concomitant 18 antipsychotic with Prozac in that patient? 19 A. As I recall that, the antipsychotic had been 20 started shortly prior to my first seeing the patient, and of 21 course the reason for prescribing the antipsychotic in the 22 first place was because the patient was psychotic. 23 Q. That makes sense. So it was your recollection 24 that the patient was already on the antipsychotic medication 25 when you began prescribing Prozac to he or she? 23 1 A. Yes, but I have continued both Prozac and the 2 antipsychotic. 3 Q. How about benzodiazepines? Have you ever 4 concomitantly prescribed benzodiazepines to patients on 5 Prozac? 6 A. Not that I remember. I use benzodiazepines very 7 infrequently. 8 Q. How about any drugs with sedative properties in 9 conjunction with Prozac? 10 A. Well, of course, an antipsychotic agent does 11 have typically some sedative properties; I don't remember any 12 other instances. 13 Q. Have any of your patients who you prescribed 14 Prozac to experienced agitation after beginning Prozac? 15 A. No. 16 Q. How about sedation? 17 A. No. 18 Q. Anxiety? 19 A. Not that I can remember offhand. 20 Q. Irritability? 21 A. No. I don't think so. 22 Q. Akathisia? 23 A. No. 24 Q. Suicidal ideation? 25 A. Questionably in one patient that I'm 24 1 remembering. 2 Q. When you say questionably, do you mean it was 3 questionable whether or not that person was actually suicidal? 4 A. Yes. 5 Q. What was your opinion? Do you feel that patient 6 was suicidal? 7 A. No. 8 Q. How did the issue arise? 9 A. I'm not sure I quite understand your question. 10 Q. Okay. Earlier you said it was questionable 11 whether or not a patient had become suicidal while taking 12 Prozac. How is it that the question arose whether or not the 13 person was suicidal? Is that something that they told you or 14 is that some behavior they manifested? 15 A. It was in the course of an interview. 16 Q. Was this person on Prozac when this interview 17 took place? 18 A. Yes. If I might add, the patient had rather 19 vaguely expressed approximately the same thoughts prior to my 20 starting. 21 Q. To the same extent? 22 A. I think so. 23 Q. Did you change your course of treatment with 24 regards to the Prozac after this person voiced suicidal 25 ideation? 25 1 A. I did discontinue the Prozac, but not for that 2 reason. 3 Q. Were you the person responsible for deciding 4 what would be included in the package insert as far as adverse 5 events and what would not? I'm talking strictly about 6 fluoxetine. 7 A. Certainly I was not the only such individual. 8 Q. Who else was responsible to make those 9 decisions? 10 A. Doctor Stark would have had input, Doctor 11 Thompson, Doctor Zerbe. 12 Q. When you say Doctor Thompson, you mean Leigh 13 Thompson? 14 A. Yes. 15 Q. Anybody else? 16 A. There probably were other individuals, but those 17 are the only ones that occur to me at the moment. 18 Q. How about Doctor Bergstram? 19 A. I can't at the moment recall a Doctor Bergstram. 20 Q. How about Doctor Lemberger? 21 A. Doctor Lemberger would have received copies of 22 drafts of the package insert, yes, and would have commented. 23 Q. Do you recall any discussions on whether or not 24 to include incidents of suicide attempts in the initial 25 package insert for fluoxetine? 26 1 A. I don't recall any such discussions. 2 Q. Do you recall incidents of suicides occurring on 3 fluoxetine trials prior to the initial insert being submitted 4 to the FDA for review? 5 A. I know that there were reports of suicide 6 attempts in patients receiving fluoxetine. I don't know -- I 7 don't recall whether any had been actual suicides or not. I 8 have a vague recollection that there were indeed discussions 9 of such reports. 10 Q. In what context? 11 A. I really don't know how to characterize the 12 context. I mean, there were ongoing discussions of adverse 13 reactions. 14 Q. If suicide attempts occurred in the clinical 15 trials prior to submitting the original insert to the FDA for 16 review, why would they not be included in the adverse event 17 listing? 18 A. I really have no answer to that question now. 19 Q. Do you feel that they should have been included? 20 A. Probably in a similar manner to statements that 21 are included in the package inserts for other antidepressants. 22 I think some of those mention the possibility of suicide. 23 Q. I'm not talking about the general cautionary 24 statements about depressed people suffering from suicidal 25 ideation; I'm talking about listing of adverse events 27 1 occurring during the fluoxetine clinical trials. Okay? If 2 those such adverse events occurred, suicidal ideation, suicide 3 attempts, completed suicide, why would they not be included in 4 a listing of the adverse events that occurred during the 5 clinical trials on fluoxetine? 6 A. I don't know. 7 Q. Do you think that they should have been if they 8 occurred? 9 A. Probably. 10 Q. And you have no idea why they would not have 11 been? 12 A. After approximately 11 years, no, I don't. 13 Q. Let's talk about that suicidality cautionary 14 statement that you brought up a couple of seconds ago. To 15 your knowledge, had anybody at Lilly ever lobbied for a 16 stronger statement with regards to patients who may be 17 suffering from suicidal ideation and the administration of 18 fluoxetine? 19 A. I don't remember anyone taking that position. I 20 can't say that it didn't happen. 21 Q. How about you? Did you feel that a stronger 22 statement should be included in the package insert, other than 23 a precautionary statement about people suffering from 24 depression becoming suicidal in general? 25 A. I don't know. 28 1 MR. SMITH: At this time, Your Honor, we have 2 Plaintiffs' Exhibit 2 -- or Dobbs Exhibit 2, which is 3 Plaintiffs' Exhibit 52 that we would offer into evidence. 4 (BENCH DISCUSSION) 5 MR. MYERS: I have the same objection to this 6 exhibit that I had to the testimony of this witness on this 7 subject; that is, that there's been no adequate foundation 8 laid. The exhibit has not been adequately identified by the 9 Witness and the Witness had no recall of the exhibit, and the 10 testimony is nothing other than the reading of the exhibit to 11 the Witness, and thus I object to its introduction through 12 this witness. 13 JUDGE POTTER: Mr. Smith? 14 MR. SMITH: This is the package-insert proposal 15 of the early package insert which has, I believe, some writing 16 on it that we were discussing with her, which may or may not 17 have been her writings. It has to do with her knowledge 18 concerning early package-insert proposals and issues of 19 whether or not suicidality and violent, aggressive behavior 20 should be included specifically as a written notation under 21 precautions on Page PZ 3642866, where there is the statement 22 concerning suicidal ideation, and there was drafts there 23 concerning hospitalizing patients who were considered possible 24 suicides. 25 JUDGE POTTER: But there is no objection to the 29 1 fact that this document is what it purports to be? 2 MR. MYERS: It is a Lilly document. 3 MR. SMITH: She was the addressee. 4 MR. MYERS: It still doesn't get over my 5 objections. The Witness had no recall and the testimony was 6 simply the reading of the document. The Court overruled my 7 objection on the testimony, but I want to preserve the 8 objection as to the document. 9 JUDGE POTTER: I'm going to sustain the 10 objection, Mr. Smith, to getting the actual document in. If 11 she can't identify it, you can get her testimony and get 12 somebody else to take it in later. Objection sustained. 13 (BENCH DISCUSSION CONCLUDED) 14 MR. SMITH: May I approach the bench one more 15 time, Your Honor, concerning how to handle this? 16 JUDGE POTTER: Sure. 17 (BENCH DISCUSSION) 18 JUDGE POTTER: You can go ahead and have her 19 introduce -- it's hard to say "her" when Dobiesz is sitting 20 over there, but go ahead and have her give her testimony. You 21 can identify what you've given to her. I'm giving you what 22 has been marked as your exhibit -- whatever it is -- 23 Plaintiffs' Exhibit No. 52 and take her through the questions, 24 but as far as actually getting the document itself into 25 evidence, it will just have to wait. 30 1 MR. SMITH: Okay. I'll do it that way. Here 2 she says on Page 77, Line 6, "I have no recollection of this. 3 I have a vague recollection of certainly one or more drafts of 4 the insert prior to submission of the NDA and soliciting 5 comments from various areas, but I have no memory of that 6 specific issue." 7 JUDGE POTTER: Let me just ask you this, Mr. 8 Myers. Is there any doubt that he's going to get this thing 9 in. 10 MR. MYERS: I don't know who else he's going to 11 offer it through. The testimony of the -- the Court has 12 overruled my objection so the testimony is going to come in. 13 So I think to the extent he needs in this evidence, he's got 14 it in. 15 JUDGE POTTER: Is Mr. Leigh Thompson going to 16 testify to that? 17 MR. MYERS: I don't know. 18 JUDGE POTTER: What's he going to say if you 19 hand it to him? 20 MR. MYERS: I don't know that he's an addressee 21 on this document, either. 22 JUDGE POTTER: Mr. Smith, if you'll just go 23 through it, and you'll have to figure out some other way to 24 get it in until somebody says, yes, this is what it purports 25 to be. 31 1 MR. SMITH: Okay. I was going to give a copy to 2 the very attractive Doctor Dobbs. 3 All right. Have you had a chance to review 4 Exhibit 2? 5 A. Yes, I have. 6 Q. Does this refresh your recollection as to who 7 Doctor Bergstram is or was? 8 A. I still can't picture Doctor Bergstram. 9 Obviously, he was involved with early studies, matters of 10 half-life metabolites, et cetera, as was Carl DeSante. 11 Q. How about Doctor Lemberger? Who was Doctor 12 Lemberger? 13 A. Doctor Lemberger was a clinical pharmacologist 14 who was generally in charge of the Phase 1 clinical trials and 15 volunteers at Wishard. 16 Q. Exhibit 2 purports to be Doctor Bergstram's and 17 Doctor Lemberger's comments on the package insert submitted to 18 them or draft of the package insert for fluoxetine submitted 19 to them by you; correct? 20 A. Yes. 21 Q. And they list, it looks like, two pages of 22 typewritten comments, and also attach a copy of the draft of 23 the package insert with some handwritten comments; correct? 24 A. Yes. 25 Q. And the second page of the typewritten comments, 32 1 the third page of the actual exhibit, at the bottom under the 2 precaution section, they seem to suggest adding statement 3 that, quote, patients -- and I'm reading from just the 4 typewritten part, not the corrected part, okay -- patients 5 with suicidal ideation should be considered for 6 hospitalization. Do you see that? 7 A. Yes. 8 Q. Do you recall that issue coming up where Doctor 9 Lemberger and/or Doctor Bergstram felt that that statement 10 should be added to the package insert under the precaution 11 section? 12 A. I have no recollection of this. I have a vague 13 recollection of circulating one or more drafts of the insert 14 prior to submission of the NDA and soliciting comments from 15 various areas, but I have no memory of that specific issue. 16 Q. Okay. Do you recall there have been meetings 17 regarding what should be included in the package insert for 18 fluoxetine? And I'm talking about intra-Lilly meetings? 19 A. It's a reasonable assumption that there may have 20 been such meetings, but I don't remember any of them. 21 Q. If you go to Page 6 of the draft of the package 22 insert itself, in the upper left-hand corner, I know it's a 23 little difficult to read because the copy is bad, but it looks 24 like up here, the section where it has the general -- 25 A. Excuse me, if I might. I gave up. I couldn't 33 1 read it. 2 Q. Okay. We'll see if we can get through it 3 together. It looks like a handwritten note up by the 4 precaution section, the general wording on suicidality in 5 depressed patients. Do you see that? 6 A. I see the note. It's -- without a great deal of 7 effort, it's largely illegible. 8 Q. My best reading of it -- to me it appears it 9 says, "Should we not state that patients with suicidal 10 ideation should be considered for hospitalization -- be 11 hospitalized?" 12 A. I think your reading is probably correct. 13 Q. Okay. Again, do you recall that issue being 14 raised at any time with regards to the package insert while 15 you were an employee at Lilly? 16 A. As I indicated previously, I have a vague 17 recollection of discussions of the issue, not necessarily 18 related specifically to the preparation of the insert. The 19 issue being occurrence of suicide attempts or possibly actual 20 suicides occurring in patients in clinical trials who received 21 fluoxetine or who received placebo or who received other 22 antidepressant agents. 23 MR. SMITH: At this time we have, Your Honor, 24 Plaintiffs' Exhibit 53. 25 MR. MYERS: It was Dobbs 3. 34 1 (BENCH DISCUSSION) 2 MR. MYERS: Again, Your Honor, this is not an 3 exhibit to which -- in fact, this exhibit was not directed to 4 this witness. She didn't write this exhibit. I believe this 5 exhibit will come in through some other witness, but in terms 6 of introducing it through this witness, it's not appropriate. 7 MR. SMITH: Again, Your Honor, this is on the 8 issue of notice; whether she's seen it or not is immaterial. 9 I'm entitled to question her about it and have her identify 10 the issues presented by this memo. She was a Lilly employee 11 at the time. This is a Lilly memo. It concerns the issues at 12 the heart of this case. 13 JUDGE POTTER: And if I remember it from 14 yesterday, she was an expert witness talking about what should 15 have been told to who about what and that's where she ends up. 16 MR. MYERS: The Court indicated yesterday that 17 it would allow the testimony questioning to her about the 18 exhibit, and that's not what I'm objecting to. 19 JUDGE POTTER: Maybe you need to go over these 20 things the day before. Right now, if she can't identify it, I 21 sustain the objection to her actually getting it in. But you 22 can go ahead and get her testimony in. 23 (BENCH DISCUSSION CONCLUDED) 24 Q. Have you had a chance to review Exhibit 3, 25 Doctor? 35 1 A. Yes. 2 Q. Have you seen this document before, Doctor? 3 A. Possibly. I don't know. 4 MR. SMITH: Your Honor, again, we would move for 5 the admission. Witness just stated possibly she had seen the 6 document. 7 JUDGE POTTER: Okay. Objection sustained. 8 Q. I understand that you're not listed as a main 9 recipient or on the "cc" list, but do you recall being alerted 10 to questions raised by regulatory agencies outside the United 11 States regarding fluoxetine? 12 A. I think I probably was. I may well have seen 13 this telex and others. But, again, I have no specific 14 recollection of it. 15 MR. SMITH: Again, Your Honor, we would move for 16 the admission of Dobbs Exhibit 3. 17 JUDGE POTTER: Objection sustained. 18 Q. What position was Doctor Zerbe in around this 19 time, if you recall? 20 A. By that time Doctor Zerbe was, I think, probably 21 the director of the neuro or neuroendocrine drug section or 22 division or whatever it was being called. Contrary to my 23 earlier statement, I think probably Doctor Zerbe would not 24 have been on the London trip. 25 Q. Would not have been on the London trip? 36 1 A. Right. 2 Q. When you say the London trip, you mean your trip 3 to London? 4 A. Correct. 5 Q. Would the concerns raised by the German 6 government, as reflected in this exhibit, have been reported 7 to the FDA, to your knowledge, back then? 8 A. Probably not. 9 Q. Why not? 10 A. I don't recall that there was any requirement 11 within the regulations that the concerns as opposed to 12 information be reported. 13 Q. Let me ask it this way, Doctor. It's our 14 understanding, okay, that in response to these concerns raised 15 by the BGA that employees at Lilly, in particular Doctor 16 Wernicke, participated in the analysis of the occurrence of 17 suicide attempts and suicides on clinical trials of fluoxetine 18 for submission to the BGA, okay? Would such a study have to 19 be submitted to the FDA, as far as you know? 20 A. The underlying data would certainly have to be 21 submitted to the FDA. Whether the analysis would need to be 22 submitted to the FDA, I can't answer as a generality. And, 23 again, it's been a long time since I dealt with such 24 questions. 25 Q. Okay. So the best that you can recall, there is 37 1 no requirement by the FDA that the concerns of another 2 regulatory agency outside the United States be submitted to 3 the FDA; correct? 4 A. That is correct. 5 Q. And to the best of your recollection, there was 6 no requirement, at least while you were working there, that 7 analyses done in response to those concerns be submitted to 8 the FDA; correct? 9 A. That's the way I remember the situation at that 10 time, yes. 11 Q. Do you know what clinical trial data was 12 submitted to foreign regulatory agencies outside the United 13 States during the time that you worked there? 14 A. I certainly don't know here in July 1994. I 15 don't believe I would have known in any detail in any way at 16 that time. 17 Q. Would it essentially have been the same clinical 18 trial data that was submitted to the FDA, to your knowledge? 19 A. Probably, yes. 20 MR. SMITH: Your Honor, at this time we would 21 move for the admission of Plaintiffs' Exhibit 54, which is 22 Dobbs Exhibit 4. 23 SHERIFF CECIL: (Hands document to jurors). 24 JUDGE POTTER: Be admitted. 25 Q. Have you had a chance to review Exhibit 4? 38 1 A. Yes. 2 Q. When you were with Lilly, did they have a system 3 for computerizing information on adverse events occurring 4 either postmarketing for a drug or during clinical trials? 5 A. Yes. 6 Q. What was Doctor Thompson's position when you 7 first started with Lilly? 8 A. I don't remember the title. He was in charge of 9 clinical research for Lilly Research Laboratories. 10 Q. Was he your superior? 11 A. Yes. Or if not initially, shortly thereafter. 12 Q. Did you report to him? 13 A. Yes. 14 Q. Do you recall a time when the FDA questioned 15 Lilly's practice of breaking the blind on fluoxetine trials to 16 transition patients into an open-label phase of the trials? 17 A. I have a very vague recollection of that 18 question coming up. 19 Q. What is your recollection of that? 20 A. I can't add anything really to your question. 21 Q. Well, how about nausea, where 23 percent of the 22 patients on fluoxetine experienced nausea and 10 percent of 23 the patients on placebo experienced nausea? What would be the 24 situation with regards to establishing a causal relationship 25 in that instance? 39 1 A. Okay. I would conclude from that that 2 fluoxetine probably results in nausea in some patients but, 3 with individual patients, that's a different situation. 4 Q. Well, if you wanted to see if an individual 5 patient was having that reaction to the drug, what could you 6 do to determine that? 7 A. You could take the patient off the drug; 8 however, if the benefit were considerable and the nausea was 9 mild, not of a clinical protocol but a clinical practice, and 10 if the patient were willing to put up with the nausea, I would 11 probably think to myself, yes, the drug might be causing this. 12 I'm not seeing anything else that troubles me in the way of 13 gastrointestinal symptoms. If the patient were willing, I 14 would continue the drug. 15 Q. Let's limit it to deciding whether or not the 16 adverse event is related to the drug, okay, as opposed to the 17 other practical implications of treating the individual 18 patient. 19 A. Okay. 20 Q. You say that one of the ways that you can try to 21 determine the causal relationship is to take the patient off 22 the drug and see if the adverse event subsides; correct? 23 A. Yes. Sometimes followed by readministration of 24 the drug. 25 Q. Commonly known as rechallenging? 40 1 A. Yes. 2 Q. Would you agree with me that rechallenging a 3 patient is probably, with regards at least to that individual 4 patient, the best way to try to determine whether or not 5 there's a causal relationship between an adverse event and the 6 use of a particular drug? 7 A. If one's goal is to try to decide the question 8 of causality, it's probably best. But, again, as a clinician, 9 I'm going to consider other factors. 10 MR. SMITH: At this time, Your Honor, we now 11 offer Plaintiffs' Exhibit 57, which was Dobbs Exhibit 7. 12 SHERIFF CECIL: (Hands document to jurors). 13 Q. Have you had a chance to review Exhibit 7? 14 A. Yes. 15 Q. Okay. Exhibit 7 purports to be a cover memo 16 written by you to Doctor Lemberger and Doctor Stark as primary 17 recipients, and four other Lilly employees as "ccs"; correct? 18 A. Yes. 19 Q. And the purpose of the memo is to transmit a 20 copy of a letter dated May 17th, 1982, to you from Doctor Paul 21 Leber, Acting Director, Division of Neuropharmacological Drug 22 Products; correct? 23 A. Yes. 24 Q. At the FDA; right? 25 A. Yes. 41 1 Q. In that letter, Doctor Leber talks about 2 requests that you apparently made to amend Protocols 26, 28 3 and 36; correct? 4 A. Yes. 5 Q. And it says -- he said that he has no objection 6 to a couple of the requests or a couple of the amendments that 7 you proposed, but recommends that the patients remain blinded 8 if you're going to switch them or continue them on in trials 9 after the double-blind phase; correct? 10 A. You said patients remain blinded? 11 Q. Right. It says, "We also recommend when 12 patients complete the blind phase of the trial, you maintain 13 the blind and either routinely switch the patients to 14 fluoxetine if they were appropriate candidates for the 15 lodge-term exposure or continue patients on the blind 16 medication for the extended phase." Correct? 17 A. Yes. 18 Q. His basic objection was breaking the blind when 19 patients had finished the blind phase of the trial? 20 A. Yes. 21 Q. And the reason he objected to that is because he 22 felt that breaking the blind would educate the investigators 23 to the action and adverse-event profile of the drug and 24 possibly make it possible for them to determine what drug 25 other patients were on that were still blinded; correct? 42 1 A. Yes. 2 Q. Now, when you have a clinical trial, you're 3 running a clinical trial on a drug, you don't have, say, 40 4 patients necessarily all on the trial together starting and 5 completing at the same time; correct? 6 A. Obviously not; correct. 7 Q. So you would have -- say if you have a clinical 8 trial where you want to have 75 patients complete the trial, 9 you could have 10 patients start one week and another, like, 10 6 weeks later have another 10 patients start; correct? 11 A. It's more likely that one would start some 12 patients this week and additional patients the following week. 13 Q. You wouldn't be running all 75 patients at once; 14 correct? 15 A. Correct. 16 Q. It's theoretical that you could have some 17 patients complete the study before other patients begin in the 18 study; correct? 19 A. Absolutely. 20 Q. And Doctor Leber was concerned that if you were 21 unblinding patients that participated, say, in the first week 22 of the study at the end of this period to be on the study and, 23 say, started other patients on the study, the investigator 24 would be educated as to what drug the person may or may not be 25 on because of their experience with the other patients; 43 1 correct? 2 A. That was the concern that was expressed, yes. 3 Q. In fact, this became a fairly serious issue 4 between Lilly and the FDA, did it not? 5 A. I really don't remember. Once I read this 6 letter and others that we've discussed, it seems a bit 7 familiar, but to go beyond the letter I can't remember what 8 happened. I may well have drafted a response. I guess my 9 cover memo suggests that I did. 10 SHERIFF CECIL: (Hands document to jurors). 11 Q. Have you had a chance to review Exhibit 8? 12 A. Yes. 13 Q. Do you recall this exhibit, Doctor Dobbs? 14 A. At the risk of repeating myself endlessly, it's 15 the same situation; I've looked at it, it seems somewhat 16 familiar. 17 Q. Okay. 18 A. It also bears a striking resemblance to my 19 writing style. 20 Q. So you're saying that you believe you did draft 21 this? 22 A. I think I drafted this, yes. 23 Q. It's a two-page response, it appears, to the 24 Food and Drug Administration, to Doctor Leber's letter dated 25 May 17, 1982, that we were just talking about; correct? 44 1 A. Yes. 2 Q. And in the letter you suggest Lilly's position 3 that breaking the blind at the end of the study does not 4 educate the investigator or possibly educate the investigator 5 as to the profile of the drug for future patients; correct? 6 A. Yes. I can't today express it any better than I 7 did then. 8 Q. Do you agree with that proposition, Doctor, that 9 breaking the blind on earlier patients does not educate the 10 investigator as to the profile of the drug, either side effect 11 or otherwise? 12 A. I assume we're talking about fluoxetine and the 13 specific studies? 14 Q. Sure. 15 A. I can't off the top of my head generalize. I 16 think my point here was that there was nothing so unique about 17 the side effects, much less the efficacy of fluoxetine, that 18 the investigator would thereby figure out what the next 19 patient and the next patient were likely to be taking. 20 Q. Well, is it one of the claims about fluoxetine 21 that it lacks a number of anticholinergic effects that 22 tricyclic antidepressants have, such as dry mouth, nausea, et 23 cetera? 24 A. May I refer back to that draft insert? 25 Q. Sure. It's Exhibit 2, I believe. 45 1 A. Yes, on Page 9. I couldn't, of course, recall 2 the figures. And if I may conjecture, if we had an 3 amitriptyline group in here at a goodly dosage, the incidence 4 there would be, depending on dosage, 20, 30 percent higher, I 5 don't know. My point is that if one is thinking of -- an 6 individual patient's dry mouth can occur in association with 7 fluoxetine, can occur with amitriptyline, can occur with 8 several others, and can occur with placebo, and so if the 9 investigator sees a patient who says I'm -- to use a frequent 10 expression -- I'm spitting cotton, and if I were the 11 investigator, I wouldn't be able to figure out, therefore, 12 that the patient was on amitriptyline or fluoxetine or placebo 13 because dry mouth can occur. 14 Q. But if you saw enough patients who were 15 suffering dry mouth and you knew from your previous experience 16 that imipramine, for instance, causes dry mouth in patients, 17 you would fairly quickly be able to educate yourself that 18 those people on the clinical trial who were suffering from dry 19 mouth would more likely be on imipramine than placebo, would 20 you not? 21 A. A little more likely, yes, but that's just a 22 probability. I still wouldn't know whether that was 23 imipramine or what. 24 Q. In fact, a lot of these guys who have been in 25 the business for years and years and years are pretty good at 46 1 being able to pick out what drug a patient is on at any given 2 time, are they not, Doctor? Not just fluoxetine; I'm talking 3 about everything. 4 A. I have heard investigators claim they can, on 5 one or two occasions. I don't know how good they actually 6 are. 7 Q. They at least think they can, don't they? 8 A. I have met one or two that thought they could. 9 Q. And obviously you are a psychiatrist? 10 A. Yes. 11 Q. And Prozac, fluoxetine hydrochloride, is a 12 medication given to people with psychiatric illnesses; 13 correct? 14 A. Yes. 15 Q. So, therefore, we're going to have the benefit 16 of your testimony as not only a medical doctor but a 17 psychiatrist, one who has a specialty of treating individuals 18 with mental illnesses; correct? 19 A. Correct. 20 Q. Do you agree, Doctor Dobbs, that depression is a 21 mental illness? 22 A. Yes. 23 Q. Do you agree, Doctor Dobbs, that for some 24 individuals suffering from some types of depression that there 25 is scientific evidence that that depression is a result of 47 1 physiological factors? 2 A. I accept that for many patients there are 3 physiological, or to be a bit technical, pathophysiological 4 changes which underlie the depression. The extent to which 5 such beliefs is based on animal data and theory, I can't 6 really elucidate right now. 7 Q. Do you have an opinion, Doctor Dobbs, as a 8 psychiatrist and medical doctor and one knowledgeable 9 concerning antidepressants and concerning depression, whether 10 or not depression and the serotonin system are related to some 11 extent in some individuals? 12 A. I share that opinion, yes. 13 Q. That it's related -- 14 A. Yes. 15 Q. -- to some extent in some individuals? 16 A. Yes. 17 Q. Would you qualify that as I have qualified that; 18 that is, depression in some individuals in some instances is a 19 result of some type of imbalance -- or, I want to say 20 abnormality -- not necessarily abnormality, but some 21 deficiency or some problem in the serotonin system in that 22 individual? 23 A. I couldn't have said it better myself, Mr. 24 Smith. 25 Q. But you are an individual who has been employed 48 1 by Lilly? 2 A. Yes. 3 Q. Who has worked for the pharmaceutical company in 4 connection with psychiatric drugs, who has practiced 5 psychiatry; correct? 6 A. Yes. 7 Q. Both before you joined Lilly -- 8 A. Yes. 9 Q. -- and now, after you've left Lilly? 10 A. Yes. 11 Q. Additionally, you're, I believe, the first 12 witness who is a medical doctor, psychiatrist, that's also 13 worked for more than one pharmaceutical company, who has now 14 gone back into private practice? 15 A. My career has taken some unusual twists and 16 turns. 17 Q. And, finally, you also are an individual, one of 18 the first that we've talked with, that's ever worked as a 19 medical doctor, psychiatrist for the Food and Drug 20 Administration; correct? 21 A. Yes. 22 Q. And when you were in the Food and Drug 23 Administration, as I understand it, you were with that 24 division or department that was responsible for psychotropic 25 drugs such as Prozac? 49 1 A. Yes. 2 Q. Obviously, when you were with the Food and Drug 3 Administration, there hadn't been any application made or 4 there was no work being done on Prozac, as far as you know? 5 A. That's correct. 6 Q. And you don't know of anything that's come to 7 light since that that makes you believe that Prozac was a 8 substance actively being investigated by Lilly back when you 9 were with the FDA? 10 A. It's my understanding that the work on 11 fluoxetine and preclinical studies started well after I left 12 FDA. 13 Q. You left the FDA in -- 14 A. End of 1970. 15 Q. All right. Does the FDA have or did this FDA 16 division that you were with, what was that, 17 neuropsychopharmacological drugs? 18 A It wasn't quite that bad. It had various 19 terms when I was there, but it was -- at the time I left, 20 anyway, it was the Division of Neuropharmacological Drug 21 Products, the same division that was noted on Doctor Leber's 22 letter, which is Exhibit 7. 23 Q. All right. 24 A. No -- yes, sorry. 25 Q. And the FDA, and specifically that division, 50 1 didn't have a laboratory where they did clinical studies on 2 psychotropic drugs, did they? 3 A. That's correct. 4 Q. We people -- we laypeople think that when a drug 5 is FDA approved, that the FDA actually takes that medication, 6 runs chemical tests and clinical trials on it, correct, or 7 that's what a lot of us think? 8 A. I imagine that that could be true. I have done 9 no survey of laymen's opinions of drug approval process. 10 Q. But that is not true, is it, Doctor Dobbs, that 11 the Food and Drug Administration tests psychotropic 12 medications and conducts clinical trials on any particular 13 psychotropic drug such as Prozac? 14 A. FDA rarely contracts clinical trials. In 15 special circumstances -- they do not routinely conduct 16 clinical trials; they do, however, do some chemical testing. 17 Q. All right. Now, to be clear, the United States 18 Food and Drug Administration did not do any clinical trials 19 with respect to Prozac, as far as you know, did they? 20 A. That's correct. They did not. 21 Q. You submitted to the United States Food and Drug 22 Administration a new drug application under your signature, 23 did you not? 24 A. Correct. 25 Q. And part of that application stated that Lilly 51 1 would perform clinical trials, did they not? 2 A. Would perform and had performed, yes. 3 Q. Had and would? 4 A. Yes. 5 Q. And it didn't ask the Food and Drug 6 Administration to do any independent clinical trials, did 7 they? 8 A. That's correct. 9 Q. And you don't know of any independent clinical 10 trials that the United States Food and Drug Administration did 11 in connection with Prozac, do you? 12 A. No, I do not. 13 Q. And, therefore, all clinical data that was 14 submitted to the United States Food and Drug Administration 15 was clinical data submitted by Eli Lilly and Company, was it 16 not, prior to its being approved? 17 A. Up to the point where I left Lilly, that's true. 18 Q. And you left Lilly in mid '85? 19 A. Correct. 20 Q. And it would not surprise you to know that there 21 was no other independent data submitted to the United States 22 Food and Drug Administration concerning any independent 23 clinical trials contracted out by the United States Food and 24 Drug Administration or any other regulatory body, would there? 25 A. It would not surprise me to learn that there 52 1 were no such studies. 2 Q. That's not unusual, is it? 3 A. That's correct. 4 Q. That the sponsor, the pharmaceutical 5 manufacturer, does the clinical trials; correct? 6 A. Well, as a question, though, the sponsor and its 7 representatives -- the sponsor is called the sponsor because 8 they sponsor clinical trials actually conducted by 9 investigators, except for the Phase 1 trials. 10 Q. And the investigators that do the human clinical 11 trials, other than the Phase 1 trials, are investigators that 12 are hired by the sponsors, are they not? 13 A. That's true. 14 Q. In other words, they're paid -- those 15 investigators that did clinical trials on Prozac to be 16 submitted to the FDA, were paid by Eli Lilly and Company, as 17 far as you know, were they not? 18 A. Yes. 19 Q. And did you know that their clinical trial 20 investigation was submitted by the investigators to Lilly? 21 A. I beg your pardon? 22 Q. Well, while you were at Lilly -- 23 A. Yes. 24 Q. -- the work that the investigators did -- 25 A. Yes. 53 1 Q. -- was submitted to Lilly. 2 A. Yes. 3 Q. Correct? 4 A. Yes. 5 Q. And then Lilly submitted that data to the Food 6 and Drug Administration; correct? 7 A. After compilation and analysis and a narrative 8 summary report and so forth, yes. 9 Q. In other words, the information that the 10 investigators who were paid by Lilly were collecting, were 11 doing, that work that they were doing was not sent directly to 12 the Food and Drug Administration, was it? 13 A. That's correct. 14 Q. It was sent to Eli Lilly and Company, wasn't it? 15 A. Yes. 16 Q. Then Eli Lilly and Company did, as you say, an 17 analysis, compilation and data entry on whatever is necessary 18 and then submitted that data to the Food and Drug 19 Administration; correct? 20 A. That's correct. 21 Q. Data was sent by the investigators to Lilly; 22 correct? 23 A. Correct. 24 Q. Volumes? 25 A. Yes. 54 1 Q. Voluminous data? 2 A. Yes. 3 Q. And that -- a lot of that data was submitted to 4 the FDA in microfiche forms, the actual case report forms that 5 recorded actual patient-by-patient, visit-by-visit 6 information; correct? 7 A. Yes. 8 Q. And that was sent on microfiche for a reason, 9 was it not? 10 A. Just the sheer volume, yes. 11 Q. The sheer volume. Wouldn't be room at the FDA 12 for that -- all that material, Number One? 13 A. I know, I've sat there. 14 Q. Number Two, the FDA doesn't go through each one 15 of those case report forms, do they? 16 A. I did. 17 Q. When you were at the FDA, you went through each 18 and every case report form that was submitted on a drug? 19 A. Yes. 20 Q. After you left, do you know of anybody that did? 21 A. No. I didn't ask the question, but... 22 Q. What's your opinion concerning whether or not 23 each and every case report form that was submitted by Eli 24 Lilly and Company to the Food and Drug Administration in 25 connection with Prozac was actually reviewed by somebody at 55 1 the FDA? 2 A. Probably didn't happen. 3 Q. Simply by virtue of the sheer volume? 4 A. Yes. 5 Q. Would you agree that the FDA is overworked and 6 understaffed? 7 A. Yes. 8 Q. And that the FDA has to rely on the sponsor, the 9 pharmaceutical manufacturer, for some help in evaluating the 10 safety and efficacy of a drug? 11 A. Yes. 12 Q. And that's based on our experience, not only as 13 an individual who has worked with the Food and Drug 14 Administration, but as an individual that's worked for two 15 separate pharmaceutical firms; correct? 16 A. Yes. 17 Q. Additionally, the FDA system of examining a drug 18 for safety and efficacy can only be as good as the information 19 that it gets; correct? 20 A. I was hung up on your word "system." I'm not 21 entirely convinced that there is one. 22 Q. Is it that disorganized? 23 A. Sometimes, yes. 24 Q. Well, use a term that you're comfortable with. 25 A. Process, procedures, whatever; that isn't the 56 1 important point. FDA reviewers -- I'm not suggesting that 2 they play got-you games, but by the same token they are not 3 adverse to raising questions, auditing, reanalyzing, 4 inspecting, et cetera. In other words, they're carrying out 5 their regulatory function to the best of their abilities. 6 Q. But sometimes they'll play got-you in an area 7 that doesn't need to have inquiry; correct? 8 A. I've known that to happen, yes. 9 Q. And sometimes they'll miss an area that does 10 need inquiry, won't they? 11 A. Well, if that's later discovered, then it must 12 not have been missed. 13 Q. All right. But you -- you have reason to 14 believe, based on your working at the FDA and working for 15 pharmaceutical firms, that sometimes there's some area that 16 actually could deserve closer scrutiny by FDA employees that, 17 just by virtue of the FDA is made up of human beings, doesn't 18 get looked at; right? 19 A. This, I have to agree, is possible. 20 Q. Now, would it be accurate to state that there 21 are other safeguards or other procedures in place by FDA 22 regulations that also help in the process of identifying risks 23 presented by particular drugs? And by that I'm speaking about 24 a postmarketing surveillance system. 25 A. That is a means of gaining additional 57 1 information, yes. 2 Q. In other words, if there is a requirement, which 3 there is, that adverse experiences that -- or adverse 4 reactions that are made known to a pharmaceutical manufacturer 5 are made known to the FDA, then there might be a greater body 6 of knowledge concerning a particular adverse event than is 7 revealed by the clinical trial process? 8 A. Please excuse me. I got sort of lost. 9 Q. I kind of got lost when I was asking it, really, 10 Doctor Dobbs. In other words, FDA law requires that if a 11 manufacturer hears of an adverse event in connection with its 12 product, that it advise the FDA of that particular adverse 13 event; correct? 14 A. Yes. Some are required to be submitted rapidly 15 and others are not. 16 Q. There's different times within which to report 17 different types of events, but -- 18 A. Yes. 19 Q. -- the theory is that if a manufacturer learns 20 that its product is the subject of a particular adverse event, 21 that that manufacturer must tell the government about it? 22 A. I would have to quibble a little bit with your 23 wording. If a manufacturer learns that an adverse event has 24 been reported in association with one of that manufacturer's 25 drugs, it must -- the report must be submitted sooner or later 58 1 to the Food and Drug Administration. 2 Q. Correct. 3 A. Without any elimination by virtue of anybody's 4 conclusion. 5 Q. The data generated by the manufacturer, 6 vis-a-vis clinical trial data, is somewhat limited, is it not? 7 A. I'm sorry. I really don't know what you mean by 8 limited. 9 Q. Well, we know that the protocols in connection 10 with Prozac included individuals with certain criteria and 11 excluded individuals with certain criteria? 12 A. That's correct. 13 Q. Allowed for some medications to be used 14 concomitantly and disallowed some medications being used 15 concomitantly? 16 A. Yes. 17 Q. So from that aspect you're not going to get as 18 broad a spectrum of patients in the clinical trial data as you 19 might expect to get in the actual postmarketing practice; 20 correct? 21 A. Correct. 22 Q. So you'll have a greater number of patients 23 exposed to the product after the clinical trials, won't you? 24 A. Yes. 25 Q. And the postmarketing data will be reflective of 59 1 that larger group of patients, will it not? 2 A. Yes. 3 Q. And most physicians don't know, in connection 4 with any particular drug, what particular patients were 5 included and excluded in the clinical trial process, do they? 6 A. The major trials would be reflected in 7 publications, ordinarily, and that, of course, is open to 8 scrutiny by anyone. 9 Q. But, for instance, Prozac is prescribed by a lot 10 of physicians who are general practitioners; correct? 11 A. I would assume so. I don't know it for a fact. 12 Q. So it might very well be that those general 13 practitioners are giving Prozac to patients who are depressed, 14 that those particular patients might have been excluded from a 15 Lilly clinical trial? 16 A. That's possible. 17 Q. I can't think of a particular instance now, but 18 generally speaking in this practice, you expect that, a 19 broader group of patients to be receiving the product 20 postmarket than during the clinical trial phase, do you not? 21 A. Yes. 22 Q. And that's known by the manufacturer? 23 A. Yes. 24 Q. And it's known by the Food and Drug 25 Administration, is it not? 60 1 A. Yes. May I add something to my answer? 2 Some of the questions are specifically addressed 3 in other contexts. For example, in most efficacy trials there 4 is an upper age limit; however, FDA expects to see, and most 5 manufacturers would conduct without being asked, some 6 investigation in elderly patients. They would frequently -- I 7 don't remember exactly what Lilly did in the case of 8 fluoxetine. They would probably try the drug in a carefully 9 supervised fashion in patients with impaired renal capacity or 10 with impaired liver function, at least to the extent of blood 11 levels. So some of the questions that arise out of 12 limitations from the major protocols are addressed. Can one 13 address every single possible concurrent medical condition; 14 no, of course not. 15 Q. That's not what I'm suggesting. I'm only 16 suggesting that postmarketing data as collected by the Food 17 and Drug Administration generally will encompass a larger 18 number of patients and a broader spectrum of patients, will it 19 not? 20 A. Certainly a broader spectrum. The actual 21 numbers, considering that most adverse experiences or 22 suspected adverse experiences go unreported, I don't know. 23 It might take quite awhile for spontaneous reports to equal 24 in number the clinical population within the studies. 25 Q. All right. So it might be that there might be 61 1 a particular event that wouldn't be picked up in postmarketing 2 reports that would be picked up in the clinical trial phase? 3 A. That's possible. 4 Q. Maybe because it was specifically looked for in 5 the clinical trial phase? 6 A. Perhaps. 7 Q. Obviously, clinical trials are done as per 8 protocols, are they not? 9 A. One hopes so. Yes. 10 Q. And in protocols -- is my understanding correct 11 that a protocol for a pivotal trial must be approved by the 12 Food and Drug Administration before the clinical trial has 13 begun or can it be approved subsequent to the trial being 14 done? 15 A. At the time I was at Lilly, there was no 16 regulatory requirement that protocols for those studies 17 intended to be pivotal have prior approval. FDA encouraged 18 submission of those protocols and discussion thereof; however, 19 it could sometimes take six months or a year to get such a 20 meeting. 21 Q. All right. 22 A. So the practical effects were arguable. 23 Q. So sometimes the trial might have been under way 24 before there was actual official FDA approval? 25 A. Yes. And sometimes there never was official FDA 62 1 approval. Ultimately, if the drug itself is approved, I 2 suppose that constitutes tacit approval of the more important 3 protocols. 4 MR. SMITH: Your Honor, this might be a point 5 where we could break. 6 JUDGE POTTER: Ladies and gentlemen, I'm going 7 to take the morning recess. As I've mentioned to you-all 8 before, do not permit anybody to talk to you about this case. 9 Do not discuss it with each other or form or express opinions. 10 We'll take a 15-minute recess. 11 (RECESS) 12 SHERIFF CECIL: The jury is now entering. The 13 jurors are present. 14 JUDGE POTTER: Please be seated. 15 Okay. Mr. Smith, you want to continue with the 16 deposition of Doctor Dorothy Dobbs? 17 (MR. SMITH & MR. DOBIESZ RESUME READING PORTIONS 18 OF THE DOCTOR DOBBS DEPOSITION) 19 Q. Continuing on Page 166, Line 12: Okay. But the 20 protocol, at least from the manufacturer's standpoint and to 21 some extent from the Food and Drug Administration, is designed 22 to look at specific issues with respect to the specific drug? 23 A. To a large degree, that's true; however, the 24 collection of adverse-reaction information is designed so that 25 if someone notices -- to be absurd -- a purple toad, that can 63 1 be reported. 2 Q. I understand that. But as far as the design of 3 the clinical trial, it's generally designed as per a protocol, 4 that is, the protocol itself is designed to look at a specific 5 issue in connection with the drug under investigation. For 6 instance, you do a study on geriatric patients, -- 7 A. Yes. 8 Q. -- that would be a situation where it's designed 9 to look at a specific issue or issues? 10 A. Yes. 11 Q. Obviously, in the Prozac protocols, they 12 required that a number of the individuals, if not all of the 13 individuals, be suffering from depression, since that was the 14 indication for which the product was being submitted? 15 A. Yes. 16 Q. Do you have any specific recollection of talking 17 with anybody at Eli Lilly and Company on an informal basis, 18 Doctor Dobbs, concerning suicidality or suicidal tendencies 19 that occurred during the clinical trials? 20 A. I have a mental picture of talking to Mrs. 21 Earlene Ashbrook; I'm sure that wasn't the only discussion, 22 and I don't know why that happens to come to mind. 23 Q. Anyone else? 24 A. Not that I can conjure up as an image at this 25 moment. 64 1 Q. You said you probably had formal meetings in 2 connection with this issue. Were you a part of any of those 3 formal meetings or is that just an assumption on your part, 4 Doctor Dobbs? 5 A. It's -- I guess it's an assumption, yes. 6 Q. Because you can't remember any formal meetings? 7 A. I can't actually remember any formal meetings; 8 correct. 9 Q. You said you might have examined the incidence 10 figures concerning suicidal tendencies or is that also an 11 assumption on your part or do you specifically recall doing 12 that? 13 A. It's somewhere between. I have a vague 14 recollection of doing that. 15 Q. All right. Do you recall what the examination 16 of the incidence figures revealed? 17 A. Not in any detail, no. 18 Q. Do you recall where you got those incidence 19 figures? 20 A. Ms. Ashbrook was probably responsible for 21 providing those. 22 Q. Is that something that you requested she provide 23 you or you're just aware that she provided that to somebody? 24 A. I'm not sure. I may have requested it, but 25 someone else may have requested it. 65 1 Q. But I think you said you don't recall what the 2 figures revealed? 3 A. I said I didn't remember the figures. By the 4 same token -- and there's a degree of assumption in this -- I 5 don't remember feeling that -- correction -- I don't remember 6 concluding in my own mind that fluoxetine was associated with 7 any greater incidence of suicide tendencies than placebo or 8 other drugs. 9 Q. All right. In connection with this issue of 10 suicidality and how it came up, we have shown you an exhibit 11 -- I don't know which it's marked -- Exhibit 3, this 12 document -- this telex from Germany that you weren't addressed 13 on, an issue from the BGA, turn to Point 14. It says, as 14 we've already explained -- "As we already explained by our 15 telex to Doctor Zerbe, June 8th of '84, we need a careful 16 analysis of suicides and suicide attempts, patient by patient, 17 symptomatology, and severity upon entry into the study, and 18 week by week until the event occurred, dose of fluoxetine, 19 side effects, et cetera. This is a very serious issue in the 20 opinion of the BGA. It might well be that we have to 21 recommend concomitant tranquilizer intake for the first two or 22 three weeks in the package literature," end quote. Did I read 23 that correctly? 24 A. Yes. 25 Q. As I understand it, you have not seen this 66 1 before? 2 A. I think I may have seen it while I was at Lilly. 3 I'm not sure. 4 Q. Would that be the first instance that you were 5 aware or where there might have been some -- you said you 6 might have had some overseas information that came in 7 concerning the issue of Prozac and suicidality. Could this be 8 what we're talking about? 9 A. I simply don't know. I -- let me see the date. 10 Q. This is June '84. 11 A. No. Based on that date, my best estimate is 12 that the informal chats and possibly formal meetings and 13 concerns and so forth occurred prior to this. 14 Q. All right. And -- 15 A. And may have been ongoing. I don't know. 16 Q. Do you know of any memos, notes, data of 17 anything in that connection? Because this is about the first 18 time we've seen it from any document. 19 A. I could be totally wrong in my estimate. You 20 know, I'm trying to be as truthful as possible. 21 Q. I understand that. 22 A. It might have been the first; my best estimate 23 is that it was not. 24 Q. All right. Do you recall ever discussing with 25 Doctor Zerbe this issue of suicidality? 67 1 A. I have no specific recollection of discussing it 2 with Doctor Zerbe. 3 Q. Turn back to Page 2 of the document, Item 10. 4 It says, "The BGA suspects fluoxetine to be a stimulating, 5 activating drug." 6 A. Excuse me. I must have misunderstood. 7 Q. Page 2, Item 10, the last sentence. "Reason: 8 The BGA suspects fluoxetine to be a stimulating, activating 9 drug (side-effect profile, suicide, suicide attempts)." Do 10 you see that? 11 A. Yes. 12 Q. Had you heard before this that Prozac could be a 13 stimulating, activating drug? 14 A. I think I've already testified that I never 15 would have characterized it as being a stimulating drug, 16 recognizing that there was a percentage of patients that 17 experience nervousness, nor would I have used the term 18 activating, whatever that means. 19 Q. Do you as a psychiatrist and a scientist 20 recognize a side-effect profile of suicide and suicide 21 attempts in connection with stimulating, activating drugs? Is 22 that known, that stimulating, activating drugs have a higher 23 incidence of side-effect profile of suicides and suicide 24 attempts? 25 A. I'm not aware of that if it's true. I was 68 1 trying to think what drugs I would regard as stimulating or 2 activating. Amphetamines, for example, I don't recall that 3 they are associated particularly with suicide attempts. I 4 don't know whether there are data on that question or not. 5 Q. Do you know Doctor Jan Fawcett? 6 A. I've heard the name. 7 Q. He's on Lilly's psychiatric advisory board. Do 8 you have -- have you ever read anything he said concerning 9 Prozac and jitteriness, nervousness, therefore presenting a 10 risk in suicidal patients requiring concomitant tranquilizers? 11 A. If I've read anything that he wrote, I didn't -- 12 I couldn't identify it now. I don't remember it. 13 Q. Do you know of anything that was done in 14 connection with Exhibit 6 yourself, that is, whether or not 15 there was this analysis of suicides and suicide attempts as 16 requested by Item 14 on Page 3? 17 A. Excuse me. I thought you said Exhibit 6. 18 Q. I'm sorry. It is Exhibit 3. It was Exhibit 6 19 to another deposition. 20 A. All right. Now that we've straightened out that 21 critical point... 22 Q. Do you know whether or not anything was done in 23 connection with this June 26, '84 telex concerning those 24 issues raised in Item 14 of the analysis that needed to be 25 done? 69 1 A. I'm virtually certain that something was done, 2 if only because the practice within Lilly Indianapolis was to 3 respond to requests from affiliates. 4 Q. Why were you not -- 5 A. Specifically, I can't tell you how we responded 6 to any of the items. 7 Q. Why would you not have been included in this 8 document, Doctor Dobbs, since you are a psychiatrist, medical 9 doctor, who was the medical regulatory scientist involved with 10 Prozac at the time? 11 A. I have no idea. 12 Q. Wasn't this something that would come under your 13 purview normally? 14 A. Yes. 15 MR. MYERS: I have an objection. 16 (BENCH DISCUSSION) 17 MR. MYERS: Your Honor, I have the same 18 objection to this exhibit being introduced into evidence as I 19 did for the Deposition Exhibit 3; that is, that Doctor Dobbs 20 is neither an author nor recipient of this document and it's 21 not properly introduced through this witness. The Court has 22 overruled my objection on the questioning of the Witness about 23 the document. 24 JUDGE POTTER: I can't remember Doctor Dobbs' 25 testimony but I assume, Mr. Smith, she does not identify this 70 1 thing. Isn't it just something that you show her and ask her 2 questions? 3 MR. SMITH: Something I show her, but the 4 purpose I show it to her is after she's seen and questioned 5 about it, she is the chief regulatory scientist of Eli Lilly 6 at that time. She's the director of regulatory affairs. The 7 issue is, has Lilly been put on notice of this as a problem. 8 This is something from their German affiliate to their home 9 office. 10 JUDGE POTTER: But there's no witness here that 11 can tell us what that is. At lunchtime -- we haven't dealt 12 with authentication of exhibits and whatnot and we'll just 13 have to deal with it at lunchtime for further witnesses, but 14 as far as this witness goes, in the absence of any prior 15 orders, I'm going to sustain the objection. 16 MR. MYERS: The document is going to be admitted 17 through another witness. I don't think it's appropriate to -- 18 MR. SMITH: There's no question as to the 19 authenticity of the document. 20 JUDGE POTTER: We may get some ground rules at 21 lunchtime. 22 MR. MYERS: I contend that the Witness has never 23 seen the document and, thus, cannot testify from the document, 24 that there's no foundation. Certainly it's a Lilly document; 25 it may well be introduced through another witness who is a 71 1 recipient on the document. Since this witness has not seen it 2 and had no knowledge of it, its admission at this time is 3 inappropriate. 4 JUDGE POTTER: We'll deal with it at lunchtime 5 about authenticating documents, but at this time at this point 6 there's been no court orders about stipulating to the 7 authenticity of documents. There's been no court orders if 8 documents are objected to but they're presumed authentic. 9 MR. SMITH: At this time I'd like to display the 10 exhibit to the witness, and Mr. Myers is not contending this 11 is not an authentic document. 12 JUDGE POTTER: I understand. You can display to 13 the Witness and ask him questions about it. 14 Mr. Myers, if you agree that this is what it 15 says it is and this is an authentic document, why can't he get 16 it in? 17 MR. MYERS: He can through another witness. But 18 I don't think it's appropriate to indict this witness with a 19 document, if you will. It will be introduced through another 20 witness. 21 JUDGE POTTER: At this point, we'll have to take 22 it up at lunchtime and maybe get some ground rules on it. 23 Objection sustained. 24 (BENCH DISCUSSION CONCLUDED) 25 Q. While he's looking at that, did you ever have 72 1 the feeling, Doctor Dobbs, that you were taken out of the loop 2 or somehow there was some information while you were an 3 employee at Eli Lilly and Company that you should have had 4 that you didn't receive? 5 A. With respect to whether I was taken out of the 6 loop, that feeling crossed my mind, but with respect to the 7 other half of your question, I have no specific reason to 8 believe that information was withheld from me and therefore 9 from the Food and Drug Administration. 10 Q. Certainly that information reflected in 11 Exhibit 3, that the BGA expected Prozac to be an activating 12 drug and that the BGA was concerned about this issue, was not 13 brought to your attention, was it, Doctor Dobbs? 14 A. As I have already testified, I think I probably 15 saw this regardless of the fact that it was not specifically 16 addressed to me. I may have been involved in the response. 17 Q. Did you, as the regulatory scientist involved at 18 the time, forward that on to the Food and Drug Administration 19 for their review? 20 A. This telex? 21 Q. Yes, ma'am. 22 A. If I heard your question correctly, it was, did 23 I ask the regulatory scientist? 24 Q. Did you, as the regulatory scientist. 25 A. Oh, I beg your pardon. I probably would not 73 1 have submitted this telex. As I said, I think I probably saw 2 it. I probably would not have submitted it, not as a matter 3 of concealing something but because this is simply expressing 4 an opinion of someone -- or more than one, perhaps, individual 5 at BGA, which individual or individuals are simply looking at 6 data already in the hands of the Food and Drug Administration. 7 I don't think this would have added anything, so I probably 8 didn't submit it. 9 Q. Okay. Look at Exhibit 9, then, and see if you 10 can tell me if you think that the BGA is looking at the same 11 data that the FDA is. 12 A. Yes. 13 Q. You were still with Lilly in April 1985, were 14 you not? 15 A. Yes. 16 Q. Which is the time this document was generated, 17 apparently? 18 A. Yes. 19 Q. Were you familiar with this problem in Germany 20 in connection with registration of Prozac as Fluctin in 21 Germany? 22 A. I certainly have no specific recollection of 23 this memo. And in this instance -- I'll make a little more 24 than a guess, I suppose, that I might not have seen this. 25 Q. Why do you suppose that, Doctor Dobbs? 74 1 A. Because of the date. 2 Q. All right. 3 A. As I left about two months later and, as I have 4 already acknowledged, there were some times when I felt a 5 little bit out of the loop. 6 Q. All right. And you think this might be 7 something by virtue of the fact that you felt out of the loop 8 and were going to be leaving in two months -- 9 A. Although no one at Lilly knew that at that time. 10 This is conjecture. 11 Q. But you were the regulatory scientist in 12 connection with Prozac in April 1985, were you not? 13 A. Yes. 14 Q. But you were not made aware of this particular 15 telex from Germany? 16 A. Well, obviously, my name does not appear among 17 the addressees. 18 Q. Well, Doctor Dobbs -- 19 A. That was the case with the earlier communication 20 where my very, very vague recollection is that I probably saw 21 it. In this case, I doubt that I saw it, but I can't be 22 certain. 23 Q. Because you think you would have remembered it 24 had you seen this, don't you, frankly, Doctor Dobbs? 25 A. Perhaps, yes. 75 1 Q. Would this report be something, as the 2 regulatory scientist involved with Prozac, that should or you 3 would have sent to the United States Food and Drug 4 Administration? 5 A. It's awfully hard to make sure what one would 6 have done 10 or 11 years ago or whatever. My reaction today 7 if I tried to imagine myself back in that setting is that I 8 would not submit these pages. I would request, rapidly 9 perhaps, certain other aspects of this. But at the least, 10 this higher-incidence paragraph, I would request information 11 behind that, what they were, going back to raw data, what were 12 the actual figures, how long was the patient on the drug, how 13 long was the patient on the comparitor drug, what differences 14 were there in the patient populations at entry and on and on 15 and on. Which isn't to say that I would foot drag for months, 16 but I would not submit a third-hand opinion on something I 17 hadn't seen. 18 Q. Well, are you saying that you would have 19 submitted the opinion itself, though? In other words, this is 20 thirdhand because this is summarizing Doctor Herrmann's 21 report; correct? 22 A. I don't really know whether I would -- in this 23 hypothetical or imaginary situation, whether I would submit 24 this or not. This, after all, was prepared by Doctor Johanna 25 Schenk. 76 1 Q. Do you know her? 2 A. I did. 3 Q. All right. 4 A. I don't recall what doctor it refers to. I feel 5 virtually certain that Johanna was not a physician and not a 6 psychiatrist. I would have, at the least, gone back to Doctor 7 Herrmann's report but I would have ordered the information 8 that I just outlined. 9 Q. The first thing you would have done, I believe 10 you said, was you would have ordered the report sent to you 11 immediately, would you not? 12 A. I think I would have, yes. 13 Q. Had you known of its existence and had you known 14 that it was being summarized with this -- in these terms, the 15 first thing you would have done as the regulatory scientist 16 involved, had you known about this, would have been to ask for 17 the report immediately; correct? 18 A. I believe so. 19 Q. That's because you've got to see the report 20 itself to really understand the true significance of the 21 summary here; correct? 22 A. Basically a summary of a summary, yes. 23 Q. This is 3 pages; the opinion is 21 pages. If 24 for no other reason, the length would indicate that it's going 25 to have more details; correct? 77 1 A. Yes. 2 Q. And it might very well have that information 3 that you said you would be impressed with, concerning how long 4 these people had been on the medication, details of the 5 particular individuals and things of that nature; correct? 6 A. Yes. 7 Q. If that were the case, that probably would be 8 something that you would have and should have submitted to the 9 Food and Drug Administration; correct? 10 A. Unless upon -- well, if upon review we -- not 11 just I alone, we had concluded that this conclusion was not 12 supported by the actual facts, then I wouldn't be in any big 13 hurry setting aside the other issues. I wouldn't see any need 14 to submit rapidly and I would sleep very well that night. 15 That is, my acute concerns would be lessened markedly. Would 16 the report need to be submitted at some point given those 17 circumstances -- we have concluded that there's nothing to it 18 for the following reasons or that it's a fallacious 19 conclusion -- would really depend. Is it simply somebody 20 else's reanalysis of information that has already gone in; 21 that becomes a debatable issue. 22 Q. Does the fact, Doctor Dobbs, that this 21-page 23 opinion is somebody that was hired by Lilly to, as it says 24 here, quote, to give best advice as a consultant to the 25 company in the registration process of fluoxetine, end quote, 78 1 would that have a significance in whether or not it should be 2 submitted to the United States Food and Drug Administration; 3 that is, the fact that Lilly had hired him as a consultant on 4 a registration question in another country? 5 A. That point doesn't strike me as terribly 6 important. 7 Q. All right. Well, then, what's important about 8 it is whether or not it's of an accurate scientific 9 conclusion? 10 A. Correct. 11 Q. And if it is accurate, it would need to be 12 forwarded and action be taken immediately; correct? 13 A. Very rapidly. The term "immediate" I think took 14 on a regulatory definition, but very rapidly. 15 Q. As soon as possible, would that be a better 16 phrase? 17 A. Yes. 18 Q. But if it's something that Lilly disagrees with 19 for what they think is a good scientific basis, then that's 20 still something that probably should be reported to the United 21 States Food and Drug Administration, just not so quickly; 22 correct? 23 A. Yes. 24 Q. And how long would you have taken as a 25 regulatory scientist, had you seen this report and had it been 79 1 a matter that you disagreed with for scientific reasons, 2 before you would have submitted it to the United States Food 3 and Drug Administration? 4 A. I'm looking at the date with respect to the new 5 drug application. I might submit it at the time of the next 6 annual report to the IND, for example. 7 Q. All right. Does the fact that this drug is 8 under investigation by the United States Food and Drug 9 Administration at this very time that this consultant 10 purportedly makes this statement concerning the high incidence 11 of suicide attempts on the Prozac group make any difference as 12 to whether or not the U.S. FDA should see it? Do you follow 13 what I'm saying? 14 A. I think part of your premise was that FDA is 15 under active investigation. 16 Q. Yes. In April of 1985 -- 17 A. Wait. I'm sorry. I'm sorry. I'm confusing 18 dates. So this is well after submission of the New Drug 19 Application -- 20 Q. Well, before it was approved? 21 A. -- but before it was approved. I'm not sure now 22 when I would have submitted it, given all of the assumptions 23 that we've made. 24 Q But you follow my point. this is a product 25 that's under investigation in Germany and it's a product 80 1 that's under investigation in the United States, both 2 concurrently? 3 A. If you forgive my quibbling, I think FDA would 4 call it under review. 5 Q. Under review. Okay. I guess the BGA in Germany 6 was reviewing it at the same time the United States Food and 7 Drug Administration was reviewing it; correct? 8 A. Yes. 9 Q. And they were reviewing this data for safety, 10 both governments were, were they not? 11 A. And efficacy. 12 Q. And efficacy. But safety for sure; right? 13 A. Yes. 14 Q. And this summary of this 21-page opinion is in 15 fact broken down into safety and efficacy; correct? 16 A. Yes. 17 Q. And the issue with respect to suicidality is in 18 the safety portion of the section; correct? 19 A. Yes. 20 Q. Of the summary? 21 A. Yes. 22 Q. Had you ever seen anybody who had expressed an 23 opinion that it is of importance to determine certain types of 24 patients who will better respond to fluoxetine than to 25 imipramine so that a higher risk might be acceptable, 81 1 expressed? Do you see where I'm reading? 2 A. Yes. The goal within psychopharmacology, -- and 3 this applies to fluoxetine as it has applied to other agents 4 back close to 30 years -- to my personal knowledge, has been 5 to identify specific patient or fairly specific patient 6 populations who might best respond to Drug A versus Drug B 7 versus Drug C, not just in the antidepressant field but 8 antipsychotic and so forth. And that goal has been avidly 9 pursued for many years, to my personal knowledge, and probably 10 still is. 11 Q. You think that's an admirable goal? 12 A. I think that's an admirable goal. And to the 13 best of my knowledge, it's never been achieved. I recall one 14 eminent expert who referred to such endeavors as Seeking-The- 15 Redheaded-Patients-With-Redheaded-Guitar-Playing- 16 Swedish-Grandmother Syndrome as his way of ridiculing, if you 17 will, the unsuccessful efforts. 18 Q. Well, but this Doctor -- this Doctor Herrmann is 19 talking about if you get people that will respond better to 20 Prozac then you will have, I assume, a lower incidence of a 21 risk that is unacceptable; is that right? Is that what he's 22 saying on the bottom of Page 2, under benefit/risk ratio? 23 A. Let me reread it, if I may. 24 Q. Sure. 25 A. I'm sorry. Would you repeat the question, 82 1 please. 2 Q. Well, isn't he saying here that in order to 3 encompass this higher risk, that is, of suicidality, we better 4 find us some patients that will respond better to Prozac than 5 to imipramine or find us some patients that will respond 6 better to Prozac than imipramine so that we can make this 7 higher risk acceptable? Isn't that what he's saying? 8 A. I guess so. I don't -- 9 Q. Is that a reasonable interpretation of what we 10 see written here? 11 A. I think so. 12 Q. Again, wouldn't it be better to have that report 13 to know specifically whether he gave any detail in connection 14 with this? 15 A. Yes. And, of course, I don't accept the premise 16 that I think he's tucked in there. 17 Q. Well -- 18 A. Based on something, I don't know what, Doctor 19 Herrmann had apparently concluded as we've said elsewhere that 20 the risk of suicide with fluoxetine is greater than with 21 imipramine. 22 Q. That's a pretty astounding statement to see, 23 isn't it, Doctor Dobbs? 24 A. Yes. And if I accepted it I might stop a few 25 patients from Prozac tonight, but I don't accept it. 83 1 Q. But you don't know whether to accept it or not, 2 do you, Doctor Dobbs, because you don't even have the benefit 3 of what this man's 21-page opinion is, do you? 4 A. Correct. I don't. 5 Q. You would be in a better position to know 6 whether to accept it or reject it -- you would be in a better 7 position to know whether to accept it or reject it if you 8 could see the full report; correct? 9 A. Somewhat. However, I don't have that bit of 10 data. But at this point, while I have long left the field, I 11 still have respect for both for my former -- both of my former 12 employers, Eli Lilly and Company and the Food and Drug 13 Administration. If this report were true, somehow it is my 14 firm conviction that Lilly and/or the FDA, and I believe both, 15 would have taken suitable action. 16 Q. What if the FDA didn't know about it, Doctor 17 Dobbs? 18 A. They may never have known of this, whatever it 19 was, but there are indeed many other studies and many other 20 sources of information. 21 Q. Doesn't the FDA want the benefit of all studies 22 and all sources of information so that they can make their 23 determination concerning these issues, Doctor Dobbs? 24 A. Yes. 25 Q. Doctor Dobbs, the issue of concomitant 84 1 medication has come up in connection with the clinical trials 2 that were conducted with respect to Prozac? 3 A. Yes. 4 Q. I'm going to give you an unstapled document that 5 we'll give you just as soon as the court reporter marks it. 6 MR. SMITH: At this time, Your Honor, we have 7 Plaintiffs' Exhibit 60, which is Dobbs Exhibit 10. 8 SHERIFF CECIL: (Hands document to jurors). 9 Q. We may be able to shorten this, Doctor Dobbs, 10 without having you go through the entire document. Exhibit 10 11 is a document that apparently is signed by you. Is that your 12 signature? 13 A. Yes. 14 Q. Dated December 17, 1984, where you transmit a 15 table containing concomitant medications administered during 16 the Prozac clinical trial; is that right? 17 A. Yes. 18 Q. Do you recall doing this? 19 A. I can very, very vaguely. I remember Doctor Lee 20 -- I vaguely remember the issue. 21 Q. Do you remember why the issue came up? 22 A. I believe in some of our earlier studies that 23 had been designed and at least in part conducted prior to my 24 joining Lilly, the protocols allowed a wide variety of CNS 25 active medication, and the major difficulty is that these 85 1 interfere with the analysis of both safety and efficacy, 2 actually. Ideally, patients in clinical trials would be 3 completely healthy except for whatever disease was under study 4 and would not ingest a single aspirin. That, of course, is 5 not real. But this -- I think I share the opinion, frankly, 6 of Doctor Lee in the earlier studies that we had. 7 Q. Too many people on too much concomitant 8 medication? 9 A. Yes. 10 Q. Too many psychotropic and concomitant 11 medications; correct? 12 A. Yes. And even -- well, some of the ones 13 mentioned under other CNS affect medications, Demerol, for 14 example, would confound the results somewhat. 15 Q. Would these patients that are listed and these 16 patients were put on these concomitant psychotropic 17 medications that might interfere with an accurate reading of 18 the safety and efficacy of Prozac, would they have been put on 19 this medication for treatment-emergent symptoms or would these 20 have been symptoms that they had experienced prior to and were 21 taking these medications at the time of entry into the 22 clinical trials? 23 A. It might have been either. 24 Q. Let me see if I can shorten my question. 25 A. Okay. 86 1 Q. Were patients -- if I'm taking a benzodiazepine 2 and I'm depressed and I fit all the criteria, will I be 3 allowed on the clinical trials? 4 A. That would depend on the wording in the 5 protocol. The question then becomes what should the protocol 6 say. 7 Q. All right. Do you have a recollection? 8 A. My recollection is that some of the studies, as 9 I said, that had been started earlier and probably before I 10 was there, allowed -- well, this says allowed psychotropics 11 including benzodiazepines and chloral hydrate and -- so two 12 patients in this group get one milligram of one of them and 13 five patients over here get ten milligrams of another for 14 three nights and it simply fouls it up. 15 Q. It's bad? 16 A. It's bad. It's scientifically bad. 17 Q. But it was allowed on the Prozac clinical 18 trials? 19 A. As I've already acknowledged, I advised within 20 Lilly that that -- before Doctor Lee did, that that practice 21 cease. 22 Q. But it didn't, did it? 23 A. We -- I believe we arrived at something that was 24 considerably cleaner. As I said, the ideal in this situation 25 is not attainable and the -- what might be attainable is to 87 1 specify one drug. You know, if a patient can't sleep, use 2 this dose of this drug and at least you can count that. 3 Q. But none of that was ever done. As far as I can 4 tell, none of the protocols were changed to reduce the amount 5 of concomitant medications. 6 A. Then my memory is failing me with great rapidity 7 because I thought we did. 8 Q. Okay. In other words, there might have been a 9 change in practice? And I don't want to mislead you. Your 10 recollection may be better than mine; you were there, I 11 wasn't. 12 A. But you've seen protocols much more recently 13 than I have. 14 Q. Okay. It might have been that you might have 15 given instructions to the investigators to limit that but 16 never changed the protocol, or which was it? Is it your 17 recollection -- if it is your recollection that you actually 18 changed -- 19 A. I thought we tightened protocols in that regard. 20 Q. And that would have been in when? 21 A. Well, I started Lilly in November of 1981 and 22 recognized this issue shortly thereafter and advised against 23 it and discussed it with Doctor Christensen. And I thought we 24 made some changes in future protocols, but I could be totally 25 wrong. 88 1 Q. Did you really see any change in practice, 2 Doctor Dobbs? 3 A. I thought we had. If you were to show me 4 successive protocols that were not different... 5 Q. Well, this is dated December 17, 1984, and it's 6 got a lot of people on concomitant medications. This is dated 7 after -- 8 A. CNS active medications? 9 Q. Yes. I mean, don't you agree this is a lot of 10 CNS active medications for a CNS drug, such as Prozac? 11 A. Are we talking about the same document? 12 Q. See, there's a tabulation behind this that lists 13 specifically drugs that were given to patients and everything 14 up through 1984, December '84, and it looks like a lot of 15 medication. 16 A. I was thinking that we had narrowed things down 17 to chloral hydrate. This is Protocol 19 and I don't remember 18 when that was initiated, of course. 19 Q. Yes. But it looks like we go through Protocol 20 19 through 35. 21 A. Obviously, my recollection is faulty. 22 Q. My point is simply -- and you're free to look at 23 this. But my point is simply, Doctor Dobbs, that it appears 24 to me that you may have been under the impression that the 25 procedure was changed where there weren't as many people 89 1 receiving concomitant psychotropic medications, but it doesn't 2 look like it in looking at these tables that were dated as of 3 December 17, 1984. 4 A. I have to agree with you. 5 MR. SMITH: That concludes the written 6 deposition of Doctor Dorothy Dobbs, Your Honor. 7 JUDGE POTTER: Thank you very much. 8 MR. SMITH: We would offer those exhibits that 9 have been received and we would additionally -- 10 JUDGE POTTER: So 45, 57, 58 and 60 are admitted 11 into evidence. 12 MR. SMITH: We would additionally reoffer those 13 exhibits that were offered that have not at this time been 14 admitted into evidence. 15 JUDGE POTTER: My ruling will stay the same. 16 Mr. Smith, do you want to call your next 17 witness? 18 MR. SMITH: Yes, Your Honor. Our next witness 19 is a video deposition of Doctor Weber. We'll take hopefully 20 just a short time to set it up. 21 JUDGE POTTER: How long is your first tape? 22 MR. SMITH: The first tape is 1 hour and 33 23 minutes long. 24 JUDGE POTTER: Why don't you look at it and see 25 if you've got a break in about an hour. Why doesn't everybody 90 1 stand up and stretch themselves while Mr. Smith is putting on 2 the videotape. 3 MR. SMITH: I'll be glad to stop it, Your Honor, 4 at 12:30, if you like. 5 JUDGE POTTER: If you find you can break after 6 12:30, why don't you. If you quit before then, it's a long 7 afternoon; if you go much past that, you get too short an 8 afternoon. 9 MR. SMITH: Also, Your Honor, we're going to 10 need to stop and start this to hand exhibits to the jurors. 11 JUDGE POTTER: Okay. That's fine. 12 (THE VIDEO DEPOSITION OF DOCTOR HANS WEBER 13 BEGINS) 14 JUDGE POTTER: Ladies and gentlemen, we're going 15 to take the lunch recess. As I've mentioned to you-all, do 16 not permit anybody to talk to you about this case, do not 17 discuss it among yourselves and do not form or express any 18 opinions about it. We'll stand in recess till 2:00. 19 (JURORS EXCUSED FOR LUNCH RECESS) 20 JUDGE POTTER: Why don't we take about five 21 minutes and then come back and talk about documents or a plan 22 for documents. 23 (THE FOLLOWING PROCEEDINGS OCCURRED IN ROOM 148) 24 JUDGE POTTER: I think at some point I mentioned 25 that I had thought we'd entered an order about exhibits, and I 91 1 find that it is still handwritten and on a tablet and in my 2 file, so perhaps that explains it. Mr. Smith started to 3 introduce some exhibits this morning and I sustained 4 objections to them, and the reason I did it is because there 5 hadn't been any prior orders entered on anything, and so I 6 felt I just had to go by the rules of evidence. And he was 7 showing these things to people who say, "No, I've never seen 8 it. I don't know what that is." That's why I did not think 9 he could admit it. 10 When we went over it yesterday with the 11 testimony, I allowed the testimony in because at some point I 12 assumed he would get the document in. And it may be very 13 important to show, for example -- what was the female doctor 14 this morning -- Dobbs never saw some telexes from Germany, and 15 when he gets them in, it will be "This is a telex from Germany 16 and the head of your liaison to the FDA says they never saw 17 them." So I think even though he can't get it in, it's 18 permissible to get evidence about them. 19 Before you get a document in, there are two 20 things you need: one is identification and the other is 21 authenticity. And let me go out and get a note that I 22 apparently didn't bring back from the -- oh, here it is. You 23 had video of Weber today and maybe Thompson or Wernecke is 24 what the road map says. 25 You know, you-all have done a lot of things 92 1 without my participation, so everything that needs to come up, 2 I don't feel like I need to cover every base because I think 3 you-all have done very well among yourselves. But this is 4 going to be a suggestion for a handling of documents; that the 5 documents that you intend to introduce be delivered two days 6 before you intend to use them and marked. In other words, 7 Wednesday's will be delivered on Monday, and unless there's an 8 objection to those documents -- Wednesday's delivered on 9 Monday -- unless there's an objection on Tuesday, the 10 authenticity and identification would be admitted and the day 11 for you-all to think about whether or not you want them 12 treated secretly would also have run the day that you -- 13 MR. MYERS: Make your objections. 14 JUDGE POTTER: -- make your objections. Then if 15 you want them held from the public or treated secretly... And 16 what we're talking about is authenticity and identification. 17 And, really, I took Mr. Myers' objections to be more that of 18 identification in the sense that the witness you handed it to 19 wasn't going to tell what it was. You know what I mean? It 20 was just "I haven't seen it." It was this document and I 21 think he was saying, well, I think it ought to come in through 22 somebody else who can say in fact this is a telex from Germany 23 or whatever it happens to be. Does anybody have any comments 24 on that? 25 And I guess with your -- when you produce it, 93 1 since identification will be an issue, you ought to give maybe 2 a -- you know, how we're doing these lists of documents, give 3 some kind of identification with it that it is -- let me just 4 take -- a contract between X and Y or a letter from Lilly in 5 Germany to Lilly in the United States, because some of those 6 things may not -- you know what I'm saying -- they may not 7 tell you what they are. 8 MR. SMITH: Let me say this, and just ask now, 9 because I had talked with Joe Freeman and the Lilly lawyers 10 all over the country, I think, including Larry, and I never 11 dreamed that there would be any problem with authenticity of 12 any document that had a PZ number. That means it came from 13 Lilly's file and it was produced to us, that it's a Lilly 14 document. 15 MR. MYERS: I can't imagine, sitting here, Your 16 Honor, that there's going to be any authenticity problem. And 17 I want the Court to understand that what happened this morning 18 was very much related to this witness and the issue of 19 identification, not whether the document would be admissible, 20 but what individual it should come in through, and whether in 21 this case, as I mentioned to the Court, Doctor Dobbs was going 22 to get stuck, if you will, with these documents. There are 23 addressees of these documents who testified about these 24 documents from personal knowledge who I'm confident they'll 25 come into evidence from. That was the purpose of my 94 1 objection; that is, a matter of timing. But I can't think of 2 a document where there will be an authenticity objection. 3 JUDGE POTTER: Then I think I read your 4 objection correctly; it was the identification of what it is. 5 MR. SMITH: Can I speak to that? 6 JUDGE POTTER: Okay. 7 MR. SMITH: For instance, this is one of the 8 documents, this is Exhibit 53, that the Court declined to 9 introduce into evidence. What this is is a telex to one of 10 Ms. -- Doctor Dobbs' employees, direct employee whom she 11 testified in her deposition that she had had discussions 12 concerning the issues of suicidality with. This is from Lilly 13 Germany. The witness, Doctor Dobbs, is additionally a Lilly 14 employee. This is cross-examination. My opinion is, and my 15 argument is, is that I don't have to get her to identify this 16 document in order to get it admitted into evidence through 17 her. If I'm questioning her about a corporate document, she's 18 a corporate employee, authored by another corporate employee 19 where the issue is notice and what they did and who told her 20 what and to who told her when. Obviously, it took half of the 21 effectiveness out of my examination of this witness by virtue 22 of the fact that the jury couldn't see what was listed here 23 concerning these things. 24 It's cross-examination. If it were independent 25 direct evidence, then probably there would need to be some 95 1 identification. There's no question about the authenticity. 2 This witness, I think for cross-examination, doesn't have to 3 be able to identify the document if the purpose of my 4 questioning is to talk about this document and that she didn't 5 know about it. Our argument is she was purposely taken out of 6 the loop on this document. 7 JUDGE POTTER: I think when we're through today 8 we're not going to have a problem. Let me just say that we 9 had not talked about this, or I was under the impression that 10 we had talked about it a little bit, and maybe it was more I 11 had done a draft of a pretrial order that never got typed up. 12 But I was under the impression this morning that there was 13 nothing to govern this, so I ruled the way I did. 14 First of all, Mr. Smith, I don't think the rules 15 of evidence have any exception for cross-examination or direct 16 examination. I do think you are allowed to get the person to 17 say, "I've never seen Exhibit 53." To get Exhibit 53 into 18 evidence, I think you've got to go through the same drill that 19 you've got to go through whether it's direct or cross- 20 examination. 21 Mr. Myers has said there is not an issue of 22 authenticity, and I don't know whether, you know, by getting 23 the Wally memo in at a separate time we're doing trial tactics 24 or not, and I don't want to get into that. You can argue that 25 by not having it you lost some of the effect of it, but it may 96 1 be also by the fact that it was kept out and the jury knowing 2 it was kept out, they may look at it more carefully. I'm not 3 going to get into the trial tactics of it. But what I'm 4 saying is I think his, and correctly so, was identification, 5 because that witness could not say this is a memo from 6 so-and-so from the German so-and-so to so-and-so. 7 MR. SMITH: If there's no question about the 8 authenticity, why is the identification critical to the 9 admission of the document? 10 JUDGE POTTER: Because the jury needs to know 11 what it is. I mean, you could go over there and get whatever 12 and show it to her and she says, "No, I've never seen it," and 13 you say, "Judge, I want to put it in." The jury has got to 14 know what it is; that this is a letter from so-and-so to 15 so-and-so. And normally you do that. "What is it? Well, 16 it's my will." 17 MR. MYERS: May I make a comment, Judge, that 18 might short-circuit this? First is, that there does have to 19 be some minimal foundational what-is-it, and I don't think 20 that was the case at least with that witness. Second, I can't 21 imagine that this is going to come up a whole lot, Number Two. 22 And, Number Three, the Court has to remember -- and I'm sure 23 the Court and Paul does -- that these depositions were taken 24 both for discovery and evidentiary purposes. And while in a 25 deposition you might be able to examine a witness about a 97 1 document the witness has not seen -- and I think the Court, 2 over objection, ruled that the witness could be questioned at 3 length about the document; it's simply when it would come in. 4 I hadn't given it as deep a thought as tactical or anything 5 else. I know that these documents come through a handful of 6 witnesses. 7 MR. SMITH: I think both of them come in this 8 afternoon with Weber. 9 MR. MYERS: And that goes to the order of proof 10 and that's Mr. Smith's deal. 11 JUDGE POTTER: And he may want it to come in 12 with somebody who can defend it and say Weber is stuck with it 13 or whoever's stuck with it. I don't know whether he's 14 planning for it to come in through a live witness or whatever. 15 Let's do it this way, that two days before, you 16 give him the marked thing and you have some kind of 17 identification. And that way, Mr. Smith, when you introduce 18 it, you can say, you know, Your Honor, I'm giving you 53. 19 MR. SMITH: Well, haven't we given him a list of 20 exhibits? 21 JUDGE POTTER: You-all have exchanged documents, 22 but as I understand it, it's in the tens of thousands. And 23 we'll get through this week all right. 24 MR. SMITH: I can't question anybody else this 25 week, then. 98 1 JUDGE POTTER: No. We're going to get through 2 this week all right. But what you need to do is -- what have 3 you got on Weber? How long is Weber going to run? 4 MR. SMITH: Most of the afternoon. 5 JUDGE POTTER: And then you're going to use? 6 MR. SMITH: Thompson. He knows the documents 7 I'm going to use this afternoon. I've attached them to his 8 deposition. He's known about it for months. 9 JUDGE POTTER: Are they identified? Because 10 what I would hope that on -- some of these are discovery 11 depositions that are being read, and what I would hope that 12 you-all would be able to say is, stop the deposition, reading, 13 whatever it is: "Judge, I'd like to introduce Plaintiffs' 14 Exhibit 56 or 53, which the parties agree is a telex from 15 Germany to the United States, dated" -- whatever the date is. 16 You've identified it. And then we'll do the drill and pass it 17 around. 18 MR. MYERS: With respect to Doctor Weber's 19 deposition, it's my recollection that with the exception of 20 one or two documents -- I think with one document you ruled 21 the testimony out so I don't think the document can come in -- 22 that they were all identified in the deposition. 23 MR. SMITH: Can we just submit a list of things 24 that we think might not be identified? I mean, we're working, 25 as it is, -- 99 1 JUDGE POTTER: I know you-all are working. 2 MR. SMITH: -- 18 to 20 hours a day. 3 JUDGE POTTER: I understand that. But I think 4 there has to be some control. You-all are preparing this. 5 You're marking them. As far as Doctor Weber goes, show him 6 what you've got. Are they all identified in the deposition, 7 you think? 8 MR. MYERS: I think with the exception of one or 9 two, I think that's the case. 10 JUDGE POTTER: The one or two, you-all agree on 11 an identification of what it is so that when you pass it to 12 the jury and give it to my sheriff you can state, "This is the 13 Lilly handbook on protocols," or whatever it happens to be, 14 because some of this stuff is not identified. And I think 15 before it comes in, it has to be what it is and it has to be 16 identified and then, you know, next week, get -- what is today 17 -- get Friday the list of what's going to be on through -- 18 have everything there that's going to be next week by Friday, 19 and that will include Monday and Tuesday, have it by Friday, 20 and then we'll get the two-day lead-in. 21 MR. SMITH: Any document, whether there's going 22 to be an identification problem or not? 23 JUDGE POTTER: If you don't think there's going 24 to be an identification problem and you want to go by the 25 rules, with video people you know who they are; with live 100 1 witnesses you may come up with something you haven't given 2 them. 3 MR. SMITH: Giving the list doesn't solve any 4 identification problem, if the Court's ruling is that I can't 5 cross-examine a corporate employee concerning another 6 corporate memo without laying an identification predicate when 7 the document on itself is already authenticated, the only 8 reason to identify the document is to authenticate it. 9 Authentication comes by virtue of either something on its 10 face -- 11 JUDGE POTTER: Most of these things, the 12 identification will be obvious from what it is. Okay? But I 13 still think it has to be identified by somebody. 14 MR. MYERS: I don't want to try to talk the 15 Court out of the Court's ruling on this two-day thing, but I 16 really don't foresee this down the road as a big problem. I 17 made these objections consistent with the objections I made 18 when we went over the depositions yesterday; it was for the 19 purpose I stated that -- I don't need to state it again -- 20 that I don't think they should come in through this witness. 21 JUDGE POTTER: If you were going to admit that 22 this was whatever it purports to be, I would have let it in 23 today. I know you would rather have it come in through a 24 different witness that knows more about it, but I would have 25 let it in. Now, if you-all want to agree that you've got all 101 1 the documents and that they, you know, you're not only 2 admitting their authenticity, you-all know it well enough to 3 where you're prepared to admit their identification, you know, 4 maybe we don't need the two-day rule. We'll just go with it. 5 MR. MYERS: Certainly for this afternoon's 6 witness, I don't think there's but one or two. 7 JUDGE POTTER: Why don't you talk to Mr. Smith 8 and get the ones that are not identified by the witness what 9 they are. And you-all talk about whether you -- talk about -- 10 MR. MYERS: I don't think it's going to be a 11 problem this afternoon. 12 JUDGE POTTER: You-all talk about whether you 13 want it to come up on future witnesses until I have something 14 to tell me I don't have to go to every peg on the rules of 15 evidence I feel I have to do that. 16 MR. SMITH: Let me give you an example of how it 17 might come up. 18 JUDGE POTTER: Okay. 19 MR. SMITH: Let's say we've got -- 20 JUDGE POTTER: The Wally memo. 21 MR. SMITH: Here's the Wally memo. It doesn't 22 have Doctor Leigh Thompson's name on it, he's going to be a 23 witness tomorrow. This is their chief scientific officer who 24 was present -- who was director of medical affairs in 1985; as 25 we say in Texas, the big dog. They've authenticated this 102 1 document by virtue of producing it with the stamp on it. 2 JUDGE POTTER: What is it? 3 MR. SMITH: He knows what it is. He knows well 4 what it is. 5 JUDGE POTTER: But the lady that was out there 6 this morning did not know what it is. It's a small point, Mr. 7 Smith, and that's what I'm saying. You've agreed as to 8 authenticity, and if you can't agree as to identity, then 9 we'll go to a two-day rule. 10 And it will cut both ways, Mr. Myers, when 11 you-all get on, you know, start putting on your evidence. You 12 know, if you-all can agree that this is a memo written by 13 the -- whatever committee it is in 1985 and sent around to the 14 people named on it, that's identification. 15 MR. SMITH: Every one of those people there with 16 the -- no, I think every one of them come under his direction. 17 They all work for him. He has responsibility for their 18 supervision. He hasn't seen this -- I guess that's an 19 argument. 20 JUDGE POTTER: If he hasn't seen it, that's what 21 you got in today. Now, because it didn't come in today, it's 22 going to be harder for you. You're going to have to do some 23 extra work with the jury to remind them this is the thing that 24 so-and-so said they didn't see, what is it. I think the 25 reason we're having difficulty, I see it as a very small point 103 1 and you see it as a nonexistent point. 2 MR. SMITH: But you're sustaining his objection 3 to it and the jury hasn't seen it; that's what makes it a big 4 point, in my judgment. You be the judge, I'll just be the 5 lawyer; I can't do anything. 6 JUDGE POTTER: I have the power of the pencil, 7 right, or the crayon. I think Mr. Myers wants it to come in 8 when it's favorable to him or in an orderly way, and to get 9 over that, you-all have got to agree what they are. And why 10 don't you-all take a look at this afternoon's. You've got 11 them right there. 12 MR. MYERS: I've got this afternoon's in a book. 13 JUDGE POTTER: Go through them. If there's 14 anything you're going to have any objection to, say, "This 15 isn't identified, but I will stipulate that when you introduce 16 it you can say this is a report," whatever it is. Because if 17 they identify it -- you know, he may identify this, "Judge, 18 I'd like to introduce this incriminating document." I don't 19 know how you'll identify it. But you-all need to get your 20 identifications set. 21 MS. ZETTLER: We have the Response to Motion for 22 Summary Judgment. Can I get this file-stamped or something or 23 do I need to get across the street or does it matter? 24 JUDGE POTTER: No. It doesn't make any 25 difference. Do you want to look it over and decide whether 104 1 104 2 you want to respond to it and let me know whether it's ready 3 for submission? 4 MR. MYERS: Yes. 5 MS. ZETTLER: I don't think we have anything 6 else outstanding, do we? Please don't do that to me. 7 (LUNCH RECESS) 8 MR. SMITH: Judge, while Mr. Myers is looking at 9 that, we would point the Court to Kentucky Rule 901, where it 10 refers to rules of authentication or identification. 11 JUDGE POTTER: Okay. 12 SHERIFF CECIL: The jury is now entering. All 13 jurors are present. Court is back in session. 14 JUDGE POTTER: Please be seated. Ladies and 15 gentlemen of the jury, we're going to continue with the 16 deposition of Doctor Weber. Again, I remind you this is to be 17 treated as if Doctor Weber were here testifying live. 18 Mr. Smith. 19 MR. SMITH: At this time, Your Honor, we have 20 handed the Witness Weber Exhibit 1, which is Plaintiffs' 21 Exhibit 61, which we'd like to offer into evidence at this 22 time. 23 JUDGE POTTER: Admitted. 24 MR. FREEMAN: No objection, Judge. 25 JUDGE POTTER: I'll tell you what, Mr. Smith. 105 1 Why doesn't everybody just stand up for a second. We'll take 2 30 seconds. You don't have to stand up unless you want to. 3 Please be seated. Go ahead, Mr. Smith. 4 MR. SMITH: At this time, Your Honor, we have 5 Plaintiffs' Exhibit 62, which was Weber Exhibit 2. And don't 6 worry, you can't read it; it's in German. 7 SHERIFF CECIL: (Hands document to jurors). 8 JUDGE POTTER: Mr. Smith, you might advise the 9 jury what you advised me so you can save them their eyesight. 10 MR. SMITH: The document is in German. It's the 11 German package insert. I think he's going to translate it for 12 us, if I remember correctly. 13 You notice they didn't raise an objection to 14 this document, Your Honor. 15 JUDGE POTTER: All right, Mr. Smith. You want 16 to start your video. 17 (VIDEO OF DOCTOR WEBER RESUMES) 18 MR. SMITH: Your Honor, since we're going to 19 have an exhibit, this might be a time to break. 20 JUDGE POTTER: Okay. Ladies and gentlemen, 21 we'll take the afternoon recess. As I've mentioned to you-all 22 before, do not permit anybody to talk to you about this case, 23 do not discuss it among yourselves and do not form or express 24 opinions about it. We'll stand in recess for 15 minutes. 25 (RECESS) 106 1 SHERIFF CECIL: The jury is entering. All 2 jurors are present. 3 JUDGE POTTER: Please be seated. Isn't an 4 exhibit where we were? 5 MR. SMITH: Yes. 6 JUDGE POTTER: It will be 63? 7 MR. SMITH: Yes, Your Honor. It's Plaintiffs' 8 Exhibit 63, which was Doctor Weber's Exhibit 3. 9 SHERIFF CECIL: (Hands document to jurors). 10 (VIDEOTAPE OF DOCTOR WEBER RESUMES) 11 MR. SMITH: At this time, Your Honor, we'd have 12 Plaintiffs' Exhibit 64, which was Weber Exhibit 4. 13 MR. FREEMAN: No objection, Judge. 14 JUDGE POTTER: Okay. Be admitted. 15 SHERIFF CECIL: (Hands document to jurors). 16 (VIDEOTAPE OF DOCTOR WEBER RESUMES) 17 JUDGE POTTER: Is that your last one? 18 MR. SMITH: This is the last one, one hour and 19 23 minutes. 20 JUDGE POTTER: Ladies and gentlemen, I'm going 21 to take the evening recess at this time. As I mentioned to 22 you-all before, do not permit anybody to speak with you or 23 talk to you about any topic connected with this trial, and any 24 attempt to do so should be reported to me. I emphasize again 25 and again the part about letting someone communicate with you; 107 1 that refers to friends as well as somebody that might have 2 connection with this case. It also includes the news media 3 and it also includes not only this case but any topic that you 4 feel might be connected with this case. Do not discuss this 5 case among yourselves or form or express any opinions about 6 it. 7 One juror is going to think I'm picking on her 8 because she was running a little late this morning, but it's 9 just something I wanted to mention. To get anything started 10 there's a lot of people that have got to be in the same place 11 at the same time. So I'm really going to ask that you make an 12 effort to be on time. Now that I've said that I'll be late 13 tomorrow 45 minutes or so. But we've all got to assume that 14 it's going to go off on time and try and be here so that we 15 can go on time. We'll -- remembering my admonition, we'll 16 stand in recess till 9:00 tomorrow morning. 17 (JURORS EXCUSED AT 4:55 P.M.) 18 JUDGE POTTER: You've worked out Mr. Fuller? 19 MR. FREEMAN: Yes, sir. We'll have him here a 20 week from Thursday morning. I called Mr. Burns this afternoon 21 and he's trying to set that up now. 22 JUDGE POTTER: So what we have is an agreement 23 for the Plaintiff to call a witness out of -- for the 24 Defendant to call a witness during part of the Plaintiffs' 25 case; is that right? 108 1 MR. SMITH: Right. But obviously we would want 2 whatever -- you say Thursday morning. We'd like to be able to 3 complete whatever we happen to have and then switch him in at 4 the next stopping point. 5 MR. FREEMAN: Certainly. 6 JUDGE POTTER: Sure. Let me go over a couple of 7 things with you. First of all, in preserving the record as 8 far as appeals, Mr. Smith, I'm going to ask when you've 9 finished one of your videos that -- when you finish one, you 10 give the copy to Ms. McBride so she can include it as part of 11 her transcript. There isn't an actual transcript. We got Mr. 12 Stark and I can't remember how many volumes. And will you be 13 sure and get his video to her and, obviously, Mr. Weber's? 14 MR. SMITH: Yes, Your Honor. 15 JUDGE POTTER: One other thing. It's my 16 understanding that you-all have worked out your problems about 17 exhibits and so we're back to no particular order about 18 producing them at a certain time or people waiving the rights 19 to object to authenticity or anything like that. You-all are 20 just going to kind of go along on your own? 21 MR. MYERS: As long as we know the day before 22 which deposition they're going to use, I can look at the 23 exhibits and tell Mr. Smith that morning if there's a problem. 24 JUDGE POTTER: And we also have the same 25 situation. He's going to have some live witnesses, so you 109 1 need to address how you're going to handle those exhibits. So 2 we've got an hour and a half tomorrow and then Mr. Thompson. 3 Is that what your plan is for tomorrow? 4 MR. SMITH: Yes, Your Honor. 5 JUDGE POTTER: Did we forget part of Ms. Dobbs's 6 deposition, because they had -- 7 MR. FREEMAN: I looked at it, Judge, and I 8 didn't think it added anything. 9 MR. MYERS: Mr. Freeman didn't like my 10 designations. 11 JUDGE POTTER: He didn't like the cheerleading. 12 My sheriff has given me a note and I just want to know whether 13 you-all want me to -- I'll just say something to her tomorrow, 14 Ms. Carolyn Selby. She's the lady that sits back there. Her 15 maiden name is Moller and the family came from Germany, and 16 the spelling used to be Moller. She felt you should know. 17 She does not know him, but she was in Germany two years ago 18 and she feels she could be related to him. 19 MR. SMITH: We're going to have to go for a 20 mistrial, Your Honor. 21 (LAUGHTER) 22 JUDGE POTTER: I don't know much about Germany, 23 but isn't Moller kind of like Smith or Jones? I'll just 24 mention something to her tomorrow. 25 MR. FREEMAN: Tell her we're just glad she's kin 110 1 to us, that's all. 2 JUDGE POTTER: I'll tell you what, Mr. Myers. 3 Since he's going to be showing you the exhibits a day ahead of 4 time, rather than wait a day before you have any -- to see 5 whether you have any right to exhibits being sort of part of 6 public domain. Unless you say at the time an exhibit is 7 introduced, "Judge, we need some time to look that over," I'll 8 assume that they can put it up on the bulletin board or 9 whatever they want to do with it, because I've got a feeling 10 there are going to be very few in that category. 11 MR. FREEMAN: Your Honor, tomorrow, we will -- 12 if I get to the direct examination of Doctor Thompson, we will 13 have some exhibits that -- I believe the plaintiffs have seen 14 all of them except a series of definitions that the Court 15 indicated that they might want to know what clinical trial and 16 synaptic cleft is and things like that, that we will have as 17 exhibits to demonstrate his testimony. 18 JUDGE POTTER: But as far as -- I see the lady 19 from Court TV here. But as far as them using one of those 20 documents in their production, unless something is said before 21 they're introduced -- but it can be said, "That's one I 22 haven't looked at, Judge, I haven't had time to look at it; 23 they can use it." 24 JUDGE POTTER: That's everything I've got. 25 MR. SMITH: I want to make it clear that I 111 1 haven't given to Mr. Myers a listing of the documents I intend 2 to use to examine Doctor Thompson. 3 JUDGE POTTER: Okay. But then you might do it, 4 because then we'll run into the same problem we had today. 5 MR. MYERS: May I inquire if those exceed what's 6 in his deposition? Maybe that's a good way to start. 7 MR. SMITH: I doubt it, Larry. Actually, I 8 should have that sometime tonight and we'll try to -- if you 9 want to meet at 8:15 in the morning, I can let you know or 10 show you what I got. 11 MR. MYERS: That's fine. I'll start looking. 12 MR. SMITH: Probably since we're going to have 13 his video anyway, probably that will give you the opportunity 14 for you and I to look at it and discuss it. 15 MR. MYERS: That's fine. I'll start with the 16 deposition. 17 JUDGE POTTER: If you-all don't have any need of 18 me, I'll see you at quarter till nine. 19 (PROCEEDINGS CONCLUDED THIS DATE AT 5:03 P.M.) 20 * * * 21 22 23 24 25 112 1 STATE OF KENTUCKY )( )( Sct. 2 COUNTY OF JEFFERSON )( 3 I, JULIA K. McBRIDE, Notary Public, State of 4 Kentucky at Large, hereby certify that the foregoing 5 Transcript of the Proceedings was taken at the time and place 6 stated in the caption; that the appearances were as set forth 7 in the caption; that prior to giving testimony the witnesses 8 were first duly sworn; that said testimony was taken down by 9 me in stenographic notes and thereafter reduced under my 10 supervision to the foregoing typewritten pages and that said 11 typewritten transcript is a true, accurate and complete record 12 of my stenographic notes so taken. 13 I further certify that I am not related by blood 14 or marriage to any of the parties hereto and that I have no 15 interest in the outcome of captioned case. 16 My commission as Notary Public expires 17 December 21, 1996. 18 Given under my hand this the__________day of 19 ______________________, 1994, at Louisville, Kentucky. 20 21 22 23 24 _____________________________ 25 NOTARY PUBLIC 113 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25