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 THURSDAY, OCTOBER 20, 1994 15 VOLUME XIX 16 17 * * * 18 19 20 21 _____________________________________________________________ REPORTER: JULIA K. McBRIDE 22 Coulter, Shay, McBride & Rice 1221 Starks Building 23 455 South Fourth Avenue Louisville, Kentucky 40202 24 (502) 582-1627 FAX: (502) 587-6299 25 2 1 2 I_N_D_E_X _ _ _ _ _ 3 4 WITNESS: DOCTOR_HANS_NIKOLAUS_SCHULZE-SOLCE _______ ______ ____ ________ _____________ - By Video Deposition - 5 Examination by Ms. Zettler............................... 7 6 WITNESS: DOCTOR_MAX_TALBOTT _______ ______ ___ _______ 7 Examination by Mr. Smith and Ms. Zettler................. 19 8 * * * 9 Reporter's Certificate................................... 75 10 * * * 11 12 13 14 15 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 NANCY ZETTLER 1405 West Norwell Lane 9 Schaumburg, Illinois 60193 10 FOR THE DEFENDANT: 11 EDWARD H. STOPHER 12 Boehl, Stopher & Graves 2300 Providian Center 13 Louisville, Kentucky 40202 14 JOE C. FREEMAN, JR. LAWRENCE J. MYERS 15 Freeman & Hawkins 4000 One Peachtree Center 16 303 Peachtree Street, N.E. Atlanta, Georgia 30308 17 18 * * * 19 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 Thursday, October 20, 1994, at approximately 9:10 A.M., said 5 proceedings occurred as follows: 6 7 * * * 8 9 SHERIFF CECIL: The jury is entering. All rise. 10 The Honorable Judge John Potter is presiding. All jurors are 11 present. Court is now in session. 12 JUDGE POTTER: Please be seated. 13 Mr. Smith, do you want to call your next 14 witness? 15 MR. SMITH: Your Honor, before we play the 16 videotape of the next witness, we would offer Plaintiffs' 17 Exhibit 162, which is Doctor Breggin's article that was 18 published in the International Journal of Risk and Safety in 19 Medicine on psychiatry's role in the Holocaust. 20 MR. FREEMAN: No objection, Judge. 21 JUDGE POTTER: Okay. Be admitted. 22 Do you want to call your next witness? 23 MR. SMITH: Your Honor, we would call at this 24 time by videotape deposition Doctor H. N. Schulze-Solce, which 25 was taken on September 16th, 1994. 5 1 JUDGE POTTER: Can you-all see that all right? 2 Ms. Ryan, would it embarrass you if I got you and Ms. Felker 3 to switch places; you think that would help things? That's 4 the taller lady sitting in front of you. Why don't you-all 5 switch places, Ms. Ryan. Ms. Felker, do you mind giving up 6 your position on the first row? 7 JUROR FELKER: Oh, maybe just a little. Do you 8 want me to get in the back? 9 JUDGE POTTER: No. I've tried to talk Ms. 10 Whitehouse out of her seat and I can't do it. 11 Ms. Whitehouse, can you see all right? 12 JUROR WHITEHOUSE: Yes, sir. 13 JUDGE POTTER: Ladies and gentlemen, as I've 14 mentioned to you-all before, a deposition is sworn testimony 15 that's taken outside the courtroom prior to trial. The 16 witness is placed under oath. Each side has a chance to 17 examine and cross-examine the witness just as they do here at 18 trial. And, you know, that proceeding can either be 19 videotaped or a written transcript can be made; sometimes both 20 are done. In this case there was a videotape, and the 21 videotape or portions of that deposition are going to be 22 played for you. Let me say, why I say portions is because 23 often when you take a deposition you don't know what maybe is 24 going to be important when you get to trial so you ask some 25 questions that later aren't that important. And so if you see 6 1 the tape stop or start, that doesn't mean anybody is trying to 2 hide anything from you. What it means is that there are 3 portions of it that are covered better by another witness or 4 no longer important or no longer in dispute. I think you-all 5 noticed when they were reading them they didn't read every 6 single page. So I wanted to explain, if there are any jerks 7 in the tape where you see they've cut, that's what they've 8 done. But I emphasize again, this is to be treated just as if 9 the witness were here testifying live. 10 Mr. Smith. 11 (VIDEO DEPOSITION OF DOCTOR H. N. 12 SCHULZE-SOLCE BEGINS; BENCH DISCUSSION) 13 MR. MYERS: I think this document is already in 14 evidence, and it was my understanding they were not going to 15 reoffer multiple copies of the same document throughout the 16 course of the trial and, in any event, I renew my hearsay 17 objection as to this document if they're going to offer it 18 again in a separate form. 19 JUDGE POTTER: Is this thing in? I haven't kept 20 up with it, Mr. Smith. 21 MR. MYERS: I think at least the attachment to 22 it is, sir. 23 MR. SMITH: Yes, Your Honor. I believe it's 24 been offered, Your Honor. I just thought it would be 25 easier -- 7 1 JUDGE POTTER: So they can follow along? 2 Because they may not have it with them. I'm not going to 3 admit Plaintiffs' Exhibit 163, but we'll tell them which one 4 it's a duplicate of. 5 MR. SMITH: Ten. It's from Doctor Weber's 6 deposition. 7 (BENCH DISCUSSION CONCLUDED) 8 JUROR HIGGS: Can we get that one exhibit that 9 we haven't gotten yet? 10 JUDGE POTTER: That's what we're dealing with 11 right now. 12 MR. SMITH: No. I think he's talking about the 13 article by Doctor Breggin. The sheriff wasn't here this 14 morning. 15 JUDGE POTTER: Oh, okay. 16 (BENCH DISCUSSION) 17 MR. SMITH: It seems to me it will be a lot 18 easier to pass them out so they don't have to find them. 19 MR. MYERS: Yeah. See, the attachments are the 20 same. The attachment is the same. 21 JUDGE POTTER: I am going to admit Exhibit No. 22 163. 23 (BENCH DISCUSSION CONCLUDED) 24 SHERIFF CECIL: (Hands both documents to 25 jurors). 8 1 (SCHULZE-SOLCE VIDEO DEPOSITION RESUMES) 2 MR. SMITH: This is another exhibit coming, Your 3 Honor. The next exhibit that's going to be referred to is 4 Plaintiffs' Exhibit 2, Your Honor, and that is the German 5 package insert that's already in evidence. 6 JUDGE POTTER: It's already in evidence. 7 MR. SMITH: We didn't make copies of this German 8 package insert. 9 JUDGE POTTER: I'm not going to admit this one 10 but you can say that you're describing Weber Exhibit 2. 11 MR. SMITH: It's already admitted as 62, I 12 believe, Your Honor. 13 (SCHULZE-SOLCE VIDEO DEPOSITION RESUMES) 14 MR. SMITH: All right. We're starting a new 15 subject. The next subject comes 12 pages later, which is 10 16 or 15 minutes later. 17 JUDGE POTTER: You want to break now or in 12 18 minutes? 19 MR. SMITH: Doesn't make any difference to me. 20 JUDGE POTTER: Don't make me decide. 21 Ladies and gentlemen, I'll tell you what. I'll 22 take the easy road out. We'll go ahead and take the morning 23 recess at this time. As I've mentioned to you-all, do not 24 permit anybody to speak to you about this case; do not discuss 25 it among yourselves. We'll stand in recess for 15 minutes. 9 1 (RECESS) 2 SHERIFF CECIL: All rise. Jurors are now 3 entering. All jurors are present. 4 JUDGE POTTER: Please be seated. 5 Mr. Smith. 6 (SCHULZE-SOLCE VIDEO DEPOSITION RESUMES) 7 MR. SMITH: At this time, Your Honor, we would 8 offer Plaintiffs' Exhibit 164, which is the deposition exhibit 9 to Doctor Schulze-Solce Exhibit 3. 10 (BENCH DISCUSSION) 11 MR. MYERS: Judge, instead of me getting up and 12 renewing objections to documents where I've already objected 13 to the testimony, may I simply have the same objection to the 14 documents that I made to the testimony; then I won't get up 15 and interrupt Mr. Smith any further, if that's all right with 16 the Court and Mr. Smith, and renew those objections. 17 JUDGE POTTER: This is just based on the fact 18 that these are documents that this person didn't generate or 19 didn't get? 20 MR. MYERS: There's a hearsay objection as 21 relates to this document that the Court took up when the Court 22 took up the issue of the testimony. 23 JUDGE POTTER: I'm going to overrule the 24 objection. 25 MR. MYERS: May I have a continuing objection? 10 1 JUDGE POTTER: I'm reluctant to do that because 2 things crop up and I don't remember that well, so we'll need 3 to conference every time. 4 MR. MYERS: Okay. 5 (BENCH DISCUSSION CONCLUDED) 6 JUDGE POTTER: Number 164 is admitted. 7 SHERIFF CECIL: (Hands document to jurors). 8 MR. SMITH: Your Honor, by way of explanation, 9 Exhibit 164 is the same document copied twice and stapled 10 together. Page 1 and 2 are an unredacted copy of the 11 document; Page 3 and 4 are the same document where there were 12 some redactions but, by virtue of court order, it had been 13 unredacted, I believe. 14 JUDGE POTTER: So is there any reason everybody 15 shouldn't pull the last two pages off? 16 MR. SMITH: I don't have any objection, Your 17 Honor. 18 JUDGE POTTER: Okay. Be admitted. 19 Go ahead, Mr. Smith. 20 (SCHULZE-SOLCE VIDEO DEPOSITION RESUMES) 21 MR. SMITH: At this time, Your Honor, there is 22 another document that we're going to introduce. It's 23 Plaintiffs' Exhibit 165, which was Exhibit 4 to Doctor 24 Schulze-Solce's deposition. 25 (BENCH DISCUSSION) 11 1 JUDGE POTTER: This is the same topic and the 2 same -- 3 MR. MYERS: A different document, yes, sir. As 4 with respect to the testimony, Your Honor, we renew our 5 objection. This document contains numerous double and triple 6 hearsay and, for that reason, we object to it. 7 JUDGE POTTER: Objection is overruled. 8 (BENCH DISCUSSION CONCLUDED) 9 SHERIFF CECIL: (Hands document to jurors). 10 (SCHULZE-SOLCE VIDEO DEPOSITION RESUMES) 11 MR. SMITH: At this time, Your Honor, we would 12 offer Plaintiffs' Exhibit 166, which was Plaintiffs' Exhibit 5 13 to the deposition of Doctor Schulze-Solce. 14 MR. MYERS: No objection. 15 JUDGE POTTER: Be admitted. 16 SHERIFF CECIL: (Hands document to jurors). 17 (SCHULZE-SOLCE VIDEO DEPOSITION RESUMES) 18 JUDGE POTTER: What page do you think you're 19 missing? 20 VARIOUS JURORS: 210. 21 JUDGE POTTER: So your package does not have a 22 PZ 2467210? 23 JUROR HIGGS: She's not giving page numbers. 24 JUDGE POTTER: You've got to live with what's on 25 there; that's all I can say. 12 1 MR. SMITH: That's why she didn't come today, 2 Your Honor. I think what she's on now, though, is page -- the 3 last three digits is 210. It's confusing because in the 4 German package insert there's patient and physician 5 information. I wasn't with her at the time she took that 6 deposition, Your Honor. 7 (SCHULZE-SOLCE VIDEO DEPOSITION RESUMES) 8 MR. SMITH: Your Honor, at this time, we'd offer 9 Plaintiffs' Exhibit 167, which is Exhibit 6 to the Doctor 10 Schulze-Solce deposition. 11 JUDGE POTTER: Be admitted. 12 SHERIFF CECIL: (Hands document to jurors). 13 (SCHULZE-SOLCE VIDEO DEPOSITION RESUMES) 14 MR. SMITH: I have another exhibit, Your Honor. 15 At this time, we would offer Plaintiffs' Exhibit 168, which is 16 Exhibit 8 to Doctor Schulze-Solce's deposition. 17 JUDGE POTTER: Be admitted. 18 SHERIFF CECIL: (Hands document to jurors). 19 (SCHULZE-SOLCE VIDEO DEPOSITION RESUMES) 20 MR. SMITH: At this time, Your Honor, the next 21 document is Plaintiffs' Exhibit 169, which was Deposition 22 Exhibit 9 to the deposition of Doctor Schulze-Solce. 23 JUDGE POTTER: Be admitted. 24 SHERIFF CECIL: (Hands document to jurors). 25 (SCHULZE-SOLCE VIDEO DEPOSITION RESUMES) 13 1 MR. SMITH: Your Honor, we have Exhibit 170 that 2 we could do now or we could take a lunch break. 3 JUDGE POTTER: How long is it to your next 4 exhibit? Can you look ahead there? 5 MR. SMITH: Ten or fifteen minutes, maybe. 6 JUDGE POTTER: Let's do another one because the 7 afternoon is going to be depositions, too, and if we quit now 8 we'll have a long afternoon. 9 (BENCH DISCUSSION) 10 MR. MYERS: Your Honor, I have the same 11 objection as I did to the testimony. The man is going to be 12 asked has he ever seen it before, and the answer is no. Your 13 Honor has said that he can testify to it, but I object 14 strenuously to the line of testimony, and this is not the 15 witness to enter it through. There is absolutely no 16 foundation laid for it to come through him. 17 MR. SMITH: This is the only way we can get 18 this. Obviously it's notice of what representations they made 19 to the FDA. It's authenticated. It is an official letter 20 signed by the medical -- director of medical regulatory 21 affairs that they're going to bring here to testify. It's not 22 hearsay; it's their own document. 23 JUDGE POTTER: Mr. Smith, we're getting back to 24 the point we had before. Mr. Myers, is there any -- there's 25 no doubt that this is an accurate copy of a letter that was 14 1 sent by Lilly in the United States to the Food and Drug 2 Administration on December 4th, 1987; is that right? 3 MR. MYERS: That's correct. It is not a 4 question as to authenticity. With regard to this witness, 5 he's never seen it and now he's going to be examined about it. 6 JUDGE POTTER: Okay. I'm going to overrule the 7 objection. 8 (BENCH DISCUSSION CONCLUDED) 9 JUDGE POTTER: Admit No. 170. 10 SHERIFF CECIL: (Hands document to jurors). 11 (SCHULZE-SOLCE VIDEO DEPOSITION RESUMES) 12 JUDGE POTTER: Is this a good time to break, 13 Mr. Smith? 14 MR. SMITH: Be fine. 15 JUDGE POTTER: Ladies and gentlemen, we'll take 16 the lunch recess. As I've mentioned to you-all, do not let 17 anybody communicate with you about this trial or any topic 18 connected with this trial. Do not discuss it among yourselves 19 or form or express opinions about it. We'll stand in recess 20 till 2:00. 21 (JURORS EXCUSED FOR LUNCH RECESS) 22 JUDGE POTTER: My sheriff has received a note 23 from some fellow -- it's the Lilly people he wants to give it 24 to -- and he would like to deliver this note to the Lilly 25 people. He wanted to talk to you-all and my sheriff told him 15 1 you-all were busy, and he left his name and number and he 2 wants to tell you how Prozac has helped his life. 3 (LUNCH RECESS) 4 SHERIFF CECIL: The jury is now entering. All 5 jurors are present. Court is back in session. 6 JUDGE POTTER: Please be seated. 7 Ladies and gentlemen, I'm going to remind you 8 again that a video -- a deposition is just as valuable and 9 just as important -- let me put it this way. Testimony given 10 by deposition should be given the same weight and attention 11 that you give testimony that's given here live in court. 12 Mr. Smith, do you want to continue the 13 deposition by videotape? 14 MR. SMITH: Yes, Your Honor. At this time we 15 would offer Plaintiffs' Exhibit 171. 16 (BENCH DISCUSSION) 17 MR. MYERS: Your Honor, as noted with respect to 18 the testimony of the witness on this subject, Number One, he 19 testified "I have never seen this document before." There's 20 no foundation for its introduction through this witness. 21 Number Two, it is not a Lilly document; it's a document from 22 the FDA and, as Mr. Smith has pointed out, neither the 23 Plaintiffs nor Lilly has had an opportunity to cross-examine 24 on this document. Hearsay. 25 JUDGE POTTER: But everyone agrees that this was 16 1 a file memorandum by Mr. Kapit he wrote to his file dealing 2 with the fluoxetine application? 3 MR. SMITH: That's correct. Same NDA number and 4 everything. 5 JUDGE POTTER: Okay. Objection is overruled. 6 (BENCH DISCUSSION CONCLUDED) 7 JUDGE POTTER: Number 171 will be admitted. 8 SHERIFF CECIL: (Hands document to jurors). 9 (SCHULZE-SOLCE VIDEO DEPOSITION RESUMES) 10 MR. SMITH: At this time, Your Honor, we would 11 offer Exhibit 172, which is the Exhibit 12 to Doctor 12 Schulze-Solce's deposition. 13 JUDGE POTTER: Be admitted. 14 MR. FREEMAN: No objection. 15 MR. SMITH: I don't see any sheriff, Your Honor. 16 JUDGE POTTER: I sent her on an errand. The 17 Court Reporter will do it. 18 COURT REPORTER: (Hands document to jurors). 19 (SCHULZE-SOLCE VIDEO DEPOSITION RESUMES) 20 MR. SMITH: At this time, Your Honor, we would 21 offer Plaintiffs' Exhibit 173, which is the Exhibit 13 to 22 Doctor Schulze-Solce's deposition. 23 (BENCH DISCUSSION) 24 MR. MYERS: For the record, Judge, I renew my 25 objection. I will still contend that this is a privileged 17 1 communication, attorney-client privilege, and I want to assert 2 it again without waiving it. 3 JUDGE POTTER: Well, as we've already 4 discussed -- I should have gotten a memo on whether it was the 5 German privilege or Kentucky privilege or whatever -- under 6 the Kentucky privilege this is something that is prepared with 7 the view whether it was actually delivered to Mr. Straeter or 8 not, it was prepared with the view that it would be delivered 9 to Mr. Straeter, so I overrule the objection. It's not a 10 confidential communication. 11 MR. MYERS: My position is that there will be no 12 proof that this was delivered outside the confines of the 13 individuals to whom it's addressed. 14 JUDGE POTTER: Okay. 15 (BENCH DISCUSSION CONCLUDED) 16 MR. SMITH: Offer 173, Your Honor. 17 JUDGE POTTER: Be admitted. 18 SHERIFF CECIL: (Hands document to jurors). 19 (SCHULZE-SOLCE VIDEO DEPOSITION RESUMES 20 TO ITS CONCLUSION) 21 JUDGE POTTER: Ladies and gentlemen, we're going 22 to go ahead and take a recess at this time. As I've mentioned 23 to you-all before, do not permit anybody to discuss this case 24 with you; do not talk about it among yourselves and do not 25 form or express opinions about it. We'll take a 15-minute 18 1 recess. 2 (RECESS) 3 SHERIFF CECIL: The jury is now entering. All 4 jurors are present. 5 JUDGE POTTER: Okay. Please be seated. 6 Mr. Smith, do you want to call your next 7 witness? 8 MR. SMITH: Yes, Your Honor. At this time we 9 would call Doctor Max W. Talbott, Ph.D., by written 10 deposition. 11 JUDGE POTTER: Ladies and gentlemen, you've 12 heard me say this before. A deposition is sworn testimony 13 taken outside the courtroom prior to trial. Each side is 14 present; each side has an opportunity to examine and then 15 cross-examine the witness just the way they do here in the 16 courtroom and, in certain circumstances, that deposition can 17 be read to you at trial as evidence; and when it is, you'll 18 give it the same weight and treatment you would as if the 19 witness were here live. 20 Mr. Smith. 21 (PORTIONS OF THE DEPOSITION OF MAX W. TALBOTT, 22 Ph.D., WERE READ, THE QUESTIONS BY MR. PAUL 23 SMITH AND THE ANSWERS BY MR. HUME MORRIS, 24 AS FOLLOWS) 25 19 1 EXAMINATION ___________ 2 3 BY_MR._SMITH_AND_MS._ZETTLER: (As Read by Mr. Smith) __ ___ _____ ___ ___ _______ 4 MR. SMITH: This is the deposition upon oral 5 examination of Max W. Talbott, Ph.D., a witness produced and 6 sworn before Antonette Thompson, RPR, and Dabney Whittaker, 7 CSR, Notaries Public at Large in and for the State of Indiana, 8 taken on behalf of the Plaintiffs in the offices of Eli Lilly 9 and Company, 307 East Merrill Street, Indianapolis, Marion 10 County, Indiana, on June 4, 1992, at 8:30 A.M., pursuant to 11 the various rules of civil procedure as to time and place 12 thereof. 13 Beginning on Page 10, Line 6, the question is by 14 myself: 15 Q. Would you state your name, please, sir? 16 A. Certainly. Max W. Talbott. The last name is 17 spelled T-A-L-B-O-T-T. 18 Q. What is your date of birth, Mr. Talbott? 19 A. It's October 16th, 1948. 20 Q. How are you now employed, sir? 21 A. I'm Director of Medical Regulatory Affairs. 22 Q. For Eli Lilly and Company? 23 A. That's correct, sir. 24 Q. Would you give us, please, Doctor Talbott, your 25 educational background starting with high school and 20 1 continuing through -- it's my understanding you have a Ph.D. 2 A. That's correct, sir. I graduated in 1966 from 3 Muncie, Indiana, South Side High School. 1970 from Ball State 4 University. I have a bachelor's degree in 1973 also from Ball 5 State University, a master's degree in 1976 from Rutgers 6 University where I received by doctorate. 7 Q. What was your bachelor's degree? 8 A. It was in biology. 9 Q. So you got a Bachelor of Science Degree? 10 A. Essentially, yes. 11 Q. You say essentially? 12 A. To be very honest with you, I never can remember 13 whether it's a Master's of Science and a Bachelor of Arts or a 14 Bachelor of Science and a Master of Arts, so with that 15 caveat... 16 Q. Your master's was at Ball State? 17 A. That's correct. 18 Q. And what was your degree there? 19 A. It was in physiology. 20 Q. Physiology? 21 A. Yes. 22 Q. Define for me in a sentence what physiology is. 23 A. It's just the function of the body. 24 Q. And your Ph.D.? 25 A. Was in immunology. 21 1 Q. Any particular emphasis in your physiology 2 master's? 3 A. Primarily, asthma, respiratory immunology. 4 Q. Your master's was in physiology only? 5 A. Just in physiology generally. 6 Q. Not any particular emphasis? 7 A. No, just general. 8 Q. Did you obtain a teacher's certificate at some 9 point down the line? 10 A. I did. 11 Q. From Ball State? 12 A. Yes. 13 Q. And you were certified by the Indiana -- 14 A. State of Indiana. Yes, sir. Let's see. We're 15 up to master's. And then when I graduated with my master's 16 degree, my first real job, so to speak, was with 17 Warner-Lambert and Company. 18 Q. When did you start with Warner-Lambert? 19 A. 1973. 20 Q. How long did you continue? 21 A. I was there until 1977. 22 Q. What job did you start out at at Warner-Lambert? 23 A. I was a scientist working in the laboratories. 24 Q. Any particular area there that you were 25 studying? 22 1 A. It was just general activities, all sorts of 2 laboratory tests and what have you, really just a kind of 3 general laboratory. 4 Q. Was that all pharmaceuticals? 5 A. Yes. 6 Q. Can you give me some of the other job titles 7 that you had? 8 A. The one that I do recall, in 1977 I was promoted 9 to a Scientist level. That was a title with a capital S, 10 Scientist, but the others I do not recall prior to that. 11 Q. Did that company require that you have a Ph.D. 12 to obtain that level? 13 A. No. 14 Q. Then what did you do after Warner-Lambert? 15 A. I joined the Bureau of Medical Devices of the 16 Food and Drug Administration. 17 Q. Why did you leave Warner-Lambert? 18 A. The FDA was -- the Bureau of Medical Devices was 19 in a hiring mode at that time; they were expanding. The 20 Warner-Lambert job situation, as far as promotion or other 21 opportunities, were starting to be limited; they were in a 22 retransfer phase, so it just looked like a career advancement 23 opportunity. 24 Q. Did you leave Warner-Lambert in good standing? 25 A. Oh, indeed. 23 1 Q. And where was your job with the Bureau of 2 Medical Devices with the Food and Drug Administration? 3 A. It was in Silver Spring, -- also two words -- 4 Maryland. 5 Q. And was that the main office of the Food and 6 Drug Administration? 7 A. No. 8 Q. Was it a branch separate? 9 A. It was the medical device branch. 10 Q. How long were you with the Food and Drug 11 Administration? 12 A. I was there until January of 1982. 13 Q. What was your starting job title with the Bureau 14 of Medical Devices of the Food and Drug Administration? 15 A. As best I can recall, it was pharmacologist. 16 Q. Are you a medical doctor, Doctor Talbott? 17 A. No, sir. 18 Q. Have you ever applied to medical school? 19 A. I believe I did, my junior year of my bachelor's 20 work, undergraduate. 21 Q. What medical schools did you apply to? 22 A. Indiana University, as best I can recall. 23 Q. Were you accepted or rejected? 24 A. Rejected. 25 Q. What was your next job with the FDA after the 24 1 title of pharmacologist? 2 A. I think, Mr. Smith, I was next a branch chief. 3 Q. Tell me what that job involved. 4 A. It was a supervisory position that had a number 5 of pharmacologists and other scientists reporting to it, or to 6 me, in this case. 7 Q. Over what particular branch were you a chief? 8 A. This was in the area of ophthalmic, eye devices. 9 Q. When did you become a branch chief in the 10 ophthalmic division? 11 A. As best I can recall, it probably would have 12 been in 1979. 13 Q. Did you say '79? 14 A. Yes, sir. '79. 15 Q. Okay. So you started in '77? 16 A. That's correct, sir. 17 Q. And you continued with the FDA from 1977 until 18 1982? 19 A. That's correct, sir. 20 Q. How long were you a branch chief with the Food 21 and Drug Administration? 22 A. Well, formally, until I completed -- until 23 January of 1982 that was my formal title. 24 Q. I take it from your response that your job 25 changed somewhat? 25 1 A. I was an acting division director during part of 2 that time, as well. 3 Q. That sounds to me like that included more 4 responsibilities? 5 A. That's correct, sir. 6 Q. Was that also over the ophthalmic devices 7 division? 8 A. Actually, the division was made up of a number 9 of different branches, and so it was the ophthalmic; ear, 10 nose, throat; and dental devices division. So it had three 11 separate groups, if you will. 12 Q. So you went from being a branch chief involved 13 only in eye devices and then became an acting director of a 14 division that included additional medical devices? 15 A. That's correct, sir. 16 Q. How many people did you supervise as a branch 17 chief in the ophthalmic division? 18 A. The best I can recall, maybe 10 to 15, and it 19 varied from time to time. 20 Q. And how many people did you supervise as an 21 acting division director? 22 A. Probably 50 to 55. 23 Q. Is that people that just reported directly to 24 you? 25 A. Oh, no, sir. The total. 26 1 Q. Why did you leave the Food and Drug 2 Administration? 3 A. I joined Eli Lilly and Company at that time. 4 Q. Did Lilly recruit you? 5 A. No. I contacted Lilly. 6 Q. Why did you contact Lilly? 7 A. I'm a native Hoosier, and my wife and I wanted 8 to come back to the midwest. 9 Q. All right. Were you in the medical division? 10 A. I believe that's what they called it; yes, sir. 11 Q. You were a regulatory associate in the medical 12 division? 13 A. As best I can recall, yes. 14 Q. And at that time your direct supervisor was the 15 director of regulatory affairs? 16 A. That's correct, sir. 17 Q. You were a regulatory associate from 1982 until 18 when? 19 A. I believe about 1984 or 1985. 20 Q. When you became regulatory scientist, was it '84 21 or '85? 22 A. Can't recall. It was in that time frame. 23 Q. Was that a promotion? 24 A. No. I don't believe a promotion came with it; I 25 think it was just a job title change. 27 1 Q. Would it have involved different job duties? 2 A. Yeah, exactly. 3 Q. Was there a written job description in existence 4 in connection with the regulatory scientist job? 5 A. No. 6 Q. The regulatory associate, I assume, was not a 7 supervisory position? 8 A. No, it wasn't. 9 Q. Was your job in 1984, as a regulatory scientist, 10 a supervisory position? 11 A. No, sir. 12 Q. But you at that time, then, became a liaison 13 with the FDA? 14 A. That's correct. 15 Q. In what respect were you a liaison with the FDA? 16 A. Well, in the sense of contacting medical 17 officers, consumer safety officers, other reviewers, as we had 18 questions about our application in the internal medicine area. 19 If questions come up on an IND or an NDA, then I was the 20 person that would make the contact. 21 Q. How long were you a regulatory scientist with 22 Eli Lilly and Company? 23 A. I believe I held that title until 1987. 24 Q. Then what job? 25 A. In 1987, I became manager of regulatory affairs. 28 1 Q. Would it be accurate to state that you were the 2 manager of regulatory affairs in December of 1987, when the 3 NDA on Prozac was approved for the treatment of depression? 4 A. That's correct. 5 Q. Did you have anything to do with that, Doctor 6 Talbott? 7 A. I did. 8 Q. What did you have to do with that? 9 A. In that instance, I was the chief FDA liaison, 10 or the liaison for Lilly with the FDA, in the approval of the 11 Prozac NDA. 12 Q. When did you begin working on the Prozac 13 project? 14 A. I would imagine it was probably a year before, 15 probably 1986. 16 Q. The FDA, in your judgment, is understaffed? 17 A. I think so, yes. 18 Q. They need more people there? 19 A. Oh, indeed. 20 Q. They could do quicker studies if they had more 21 people? 22 A. I don't think that the agency has ever, for a 23 moment, compromised the safety and efficacy evaluations; 24 they've just taken a long time to do reviews. So I guess if 25 their safety and efficacy evaluations stayed at the same high 29 1 level and they got additional resources, we could assume 2 probably those reviews would get done sooner, yes. 3 Q. But, frankly, they're just not given enough 4 money, are they? 5 A. You'll never hear me say that the FDA shouldn't 6 get every bit of support that they possibly could. 7 Q. They need more support, don't they? 8 A. Indeed. 9 Q. It would work to Lilly's benefit and the 10 public's benefit if they had that support? 11 A. To everyone, everybody. 12 Q. They need more support with respect to manpower? 13 A. Yes. 14 Q. With respect to funding? 15 A. Yes. 16 MR. SMITH: Now, this is the deposition of 17 Doctor Talbott that continued on April 19th and 20th, 1994, 18 sometime later, beginning on Page 15 at Line 6: 19 And what work -- and that work that you did for 20 Lilly since 1982 has been in assisting Eli Lilly and Company 21 in complying with Food and Drug Administration's regulations 22 with respect to the pharmacy industry -- pharmaceutical 23 industry; is that correct? 24 A. In part, yes, that's part of my job. 25 Q. That those duties involved Prozac to a large 30 1 extent, did they not? 2 A. Starting in 1985 that -- that's correct, sir. 3 Q. Once you became a regulatory scientist, you were 4 dealing on a regular basis with the Food and Drug 5 Administration in connection with the approval of Prozac as a 6 drug to be consumed by citizens of the United States? 7 A. That's correct, sir. 8 Q. And after 1985, or by 1985, when you became a 9 regulatory scientist, your work dealt exclusively with Prozac, 10 did it not? 11 A. I had other drugs under my responsibilities, but 12 I dealt with Prozac, yes. 13 Q. Did there come a period of time when you were 14 just dealing with Prozac in connection with securing FDA 15 approval? 16 A. It was the vast majority of the work. I had 17 responsibilities for some other drugs, but Prozac was the vast 18 majority of the work. 19 Q. All right. Would the NDA have all the 20 information that Lilly had on Prozac, comma, fluoxetine 21 hydrochloride, comma, that Lilly had in connection with 22 Prozac? 23 A. Well, again, like I said a little bit earlier, I 24 can't really comment that every time that somebody wrote 25 Prozac or fluoxetine within the corporation, that memo found 31 1 its way to the NDA. But I would answer your question by 2 saying all of the information obtained by studies conducted 3 under the NDA and related internal -- 4 MR. STOPHER: IND. 5 A. Excuse me, IND -- and related internal studies 6 on toxicology, development, manufacturing and control, 7 et cetera, would be in the NDA. 8 Q. Well, if there was a -- if there were notes made 9 by Lilly employees concerning meetings with the Food and Drug 10 Administration employees, would those be submitted to the Food 11 and Drug Administration as part of the NDA? 12 A. No, they would not. 13 Q. For the same reasons that you gave me earlier 14 concerning the IND? 15 A. That's correct, sir. 16 Q. That is, that internal memoranda generated by 17 Lilly are not required to be submitted to the Food and Drug 18 Administration? 19 A. Yes, sir. 20 Q. Is it the -- based on your experience with 21 the -- well, being with the Food and Drug Administration and 22 based on your experience being in regulatory affairs with Eli 23 Lilly and Company, is it the extent of the federal regulations 24 -- is it the intent of the federal regulations, as far as you 25 know, that the requirements to submit material to the Food and 32 1 Drug Administration is basically that a pharmaceutical firm 2 should submit to the Food and Drug Administration as much 3 information as they know concerning the particular product 4 drug being investigated? 5 A. The regulations are very explicit about the kind 6 of information that is to be submitted. And it's always been 7 our policy, and in my observation our practice, to follow 8 those to the letter. So information that fits either the IND 9 or the NDA requirements, I agree with you, yes, that's exactly 10 why we submit them. 11 Q. Is it Lilly's policy to let the Food and Drug 12 Administration have as much information concerning the 13 properties of Prozac that Lilly has? 14 A. I think that's a fair statement, yes. 15 Q. Whether the federal regulations specifically 16 actually require a piece of information to be submitted from 17 Lilly to the FDA, is it Lilly's policy to let the Food and 18 Drug Administration have the benefit of as much knowledge 19 concerning Prozac as Lilly does? 20 A. Again, I know I'm being tedious, and please bear 21 with me, but when you say "information" that means to me 22 again, you know, if there is one memorandum that has the term 23 fluoxetine in it, theoretically that's information about 24 fluoxetine. And I can't sit here this morning and say that 25 every time the word fluoxetine is used in a memoranda we 33 1 submitted that piece of information to the agency, but 2 technical information as described under the IND and the NDA 3 regs, yes. 4 Q. Let's be more specific here. How about 5 information concerning the side effects of Prozac? Would it 6 be Lilly's policy to submit all information that Lilly had 7 concerning the side effects or potential side effects of 8 Prozac to the Food and Drug Administration? 9 A. Yes, sir. 10 Q. Would it be Lilly's policy to submit to the Food 11 and Drug Administration all information concerning adverse 12 experiences sustained by patients or individuals taking Prozac 13 to the Food and Drug Administration? 14 A. Yes, sir. 15 Q. Is the information that is learned about Prozac 16 in other countries submitted to our United States regulatory 17 body, the United States Food and Drug Administration, by 18 Lilly? 19 A. Yes, sir. 20 Q. All information? 21 A. To my understanding, yes, sir. 22 Q. Is information concerning memoranda between 23 Lilly employees in a foreign country and Lilly employees in 24 Indianapolis, concerning specific reporting requirements and 25 characteristics of adverse reactions, submitted by Lilly to 34 1 the United States Food and Drug Administration? 2 A. I lost the train on that. Would you mind 3 reading it back to me? If you can tell me which one you 4 meant, then I think I can answer. 5 Q. Were there any memoranda? 6 A. The memoranda themselves perhaps would not be, 7 but the information contained in them would probably be 8 submitted in a summary fashion or in an official submission. 9 The memoranda -- in answer to your question now as I 10 understand it, the memoranda themselves would not. 11 Q. Why? 12 A. Again, I think this falls under the discussion 13 we've had earlier; that internal correspondence, memoranda 14 between Lilly individuals, even memoranda about Lilly meetings 15 with FDA people and telephone conversations with FDA people, 16 we've not submitted as part of the application. 17 Q. Well, what if there was a discussion within 18 employees of Eli Lilly and Company concerning how to 19 characterize a particular adverse event and how to report a 20 particular adverse event? Wouldn't that be something that 21 should be submitted to the Food and Drug Administration? 22 A. On the adverse event, certainly. 23 Q. Well, not just a 1639 or an international report 24 of an adverse event, but if there were discussions concerning 25 how specifically to characterize that adverse event with 35 1 respect to reporting purposes, shouldn't that be submitted to 2 the Food and Drug Administration? 3 A. You mean the dialogue of our conversation about 4 how to classify a particular adverse event? 5 Q. Yes. 6 A. I don't know that the agency would want that or 7 could even use that. I think what they would be concerned 8 with is our characterization of the event, if we used the 9 COSTART terminology, and then if we reported it within the 10 regulatory mandated time frames, ten days for INDs, 15 days 11 for serious, unexpected, spontaneous events, et cetera. 12 Q. You are now director of worldwide regulatory 13 affairs? 14 A. Yes, sir. 15 Q. While you were the director of medical 16 regulatory affairs, did you consider the Food and Drug 17 Administration as being an adversary with Lilly in connection 18 with Prozac? 19 A. I think adversary might be a little too strong. 20 Q. What term would you use, then? 21 A. Federal regulatory agency, law enforcement 22 agency. 23 MR. SMITH: At this time, Your Honor, we have 24 Plaintiffs' Exhibit 100, which was Exhibit 2 to Doctor 25 Talbott's deposition. 36 1 JUDGE POTTER: Be admitted. 2 SHERIFF CECIL: (Hands document to jurors). 3 Q. You dictated the memo, Number Two, didn't you? 4 A. I wrote it and I authored it; I don't think I 5 dictated it, per se. 6 Q. You wrote it; correct? 7 A. That's correct, sir. 8 Q. Was there any data analysis done subsequent to 9 this meeting as discussed with the FDA to test whether or not 10 the Teicher assertions were in fact real? 11 A. "Subsequent to" being the operative phrase? 12 Q. Yes, sir. 13 A. Yes, sir; there were. 14 Q. What data analyses were done? 15 A. Those were data analyses that I think were fully 16 represented and discussed at the advisory committee meeting, 17 the FDA advisory committee meeting, that occurred I believe 18 about a year later in 1991. 19 Q. Do you know of any other? 20 A. Well, that is -- when I say, that would be an 21 analysis, if you look at the entire thing, it would be 22 comprised, I'm sure, of many different individual analyses. 23 Q. Okay. 24 A. Am I making my point? 25 Q. Uh-huh. 37 1 A. So that would be the analysis. You asked me 2 about the analysis; that's the analysis. But it's made up not 3 just of a single data point but many, many, many. 4 Q. Was there a discussion in September of 1990, 5 that there was going to be an advisory committee called to 6 examine this question of whether or not Prozac was related to 7 suicidality, Doctor Talbott? 8 A. At this particular meeting, sir? 9 Q. Yeah. 10 A. I assume there wasn't or we would have put that 11 in there, or I would have put that in there. 12 Q. When did you first know that there was going to 13 be an FDA advisory committee meeting convened to specifically 14 examine this issue? 15 A. Probably late summer or so of '91. 16 Q. Before September of '91, when the meeting 17 actually occurred? 18 A. Yes. 19 Q. Do you know, Doctor Talbott, whether or not 20 there were any clinical trial designs done subsequent to this 21 memo which would test whether or not Teicher's assertions were 22 in fact real? 23 A. Yes, there were. There were. 24 Q. What clinical trials were designed to test 25 whether or not the Teicher assertions were real? 38 1 A. There were a number, and I recall this both from 2 looking -- both just from general memory and then also from 3 looking through the documents in preparation for our 4 deposition today, that Doctor Zerbe several times was in 5 contact by phone with FDA talking about trial designs, various 6 trial designs. Enrichment is a term that sticks in my head. 7 I think there was something called an enrichment trial design. 8 I'm not a physician, so I can't speak to the specifics of a 9 clinical trial design, that's not my expertise, but I do 10 recall from general memory and also from the memoranda that 11 I've looked through in preparation for today, that there were 12 those conversations, particularly between Doctor Zerbe and 13 people at the FDA. 14 Q. Do you know if there were any specific clinical 15 trials done by Lilly designed to examine the issue of whether 16 or not Prozac causes suicidality? 17 A. No, because I think what would -- I think what 18 happened was by the time that we could have agreed upon design 19 with the FDA and initiated the trials, the advisory committee 20 meeting took place and the results of the advisory committee 21 meeting I think were such that FDA and Lilly felt that no 22 additional studies were needed. 23 Q. Do you know of any, or is the answer to your 24 question there were no clinical trials designed by Eli Lilly 25 and Company to test whether or not Prozac causes suicidality? 39 1 A. Okay. The most recent question, as I understand 2 it, was, were there any trials designed. And, yes, there were 3 a number of trials designed, based on my earlier discussion, 4 where I do recall that there were conversations about trial 5 designs. And in preparation for today, I do remember seeing 6 some memoranda of telephone conversations from Doctor Zerbe to 7 various people at FDA talking about trials that we had 8 designed. So the answer to that is -- to your question is, 9 yes, there were trials designed. 10 Q. Did you -- do you recall seeing any actual 11 protocols that were submitted or done, that were done or 12 submitted to the FDA concerning these particular trials? 13 A. I don't recall seeing any, no. 14 Q. Do you know what a protocol is, Doctor Talbott? 15 A. Yes, sir; I do. 16 Q. Is it the requirement of the Food and Drug 17 Administration or is it the policy of Eli Lilly and Company 18 that any protocol for any clinical trial must be submitted and 19 approved by the Food and Drug Administration? 20 A. It's not only our policy, but I think under the 21 IND regulations it's a federal requirement. 22 Q. Did you as director of medical regulatory 23 affairs for Eli Lilly and Company, ever submit to the FDA any 24 protocol designed to test whether or not there was an 25 association between Prozac and suicidality? 40 1 A. I don't recall any, but the application file 2 would be a better source, because if there were one done it 3 would be in there. But my recollection is that I do not 4 recall one. My answer is that I do not recall one. 5 Q. Do you recall receiving approval from the FDA to 6 do a particular protocol to test whether or not there was a 7 relationship between Prozac and suicidality? 8 A. No, sir; I don't. 9 Q. Now, as I understand it, even though there may 10 have been some design of some clinical trials to test this, 11 there was, in fact, never actually any clinical trials done to 12 test this; is that correct? 13 A. That's correct, sir. 14 Q. Did you ever -- do you recall as director of 15 medical regulatory affairs ever requesting permission from the 16 Food and Drug Administration to not conduct a clinical trial 17 designed to test the issue of whether or not Prozac caused 18 individuals to become suicidal? 19 A. No. 20 Q. Do you know -- strike that. 21 Yes. Because my question was clinical trials 22 that were designed to test this question. 23 A. Specifically for that question? 24 Q. Yeah. 25 A. No. 41 1 Q. Well, do you know whether or not, as director of 2 medical regulatory affairs, any of the protocols that were 3 actually done as clinical trials had as a part of that 4 protocol the specific examination of the question of whether 5 or not ingestion of fluoxetine caused suicidal ideation by 6 depressed individuals? 7 A. Specifically, no, I do not. 8 Q. Do you know of any trials in the entire clinical 9 trial experience that were conducted to test or to use Prozac 10 to treat people who were suicidal? 11 A. Again you're starting to press the level of my 12 expertise here, and I will answer on the basis of 13 understanding that I'm not a physician, and that's starting to 14 get very clinically specific. But I don't, in my position as 15 medical regulatory affairs director, do not recall any such 16 trials. 17 Q. So we will be clear, Doctor Talbott, the Food 18 and Drug Administration did not conduct any clinical trials on 19 human beings concerning Prozac, did they? 20 A. That's correct. 21 Q. The Food and Drug Administration didn't conduct 22 any clinical trials or trials of any nature on animals? 23 A. Not to my understanding they didn't; no, sir. 24 Q. Since December 1987, are you aware of any 25 clinical trials that have been done by Lilly that have a 42 1 protocol that has, as any part, an objective or a component of 2 a reason to do the investigation to examine the question as to 3 whether or not Prozac causes suicidal ideation in humans? 4 A. Specifically, no. 5 Q. Generally? 6 A. Again, adverse events is a part of any clinical 7 trial. 8 Q. And when you say adverse events, you're talking 9 about -- well, if there were reported suicidal ideation or 10 suicide attempts as an adverse event in connection with that 11 clinical trial, then we would know that by virtue of it being 12 reported by the investigator? 13 A. That's correct, sir. 14 Q. But that would only be incidental to the purpose 15 of the clinical trial? 16 A. Looking for the specific adverse event or any 17 specific adverse event, per se, would be incidental and not 18 specific to it. 19 Q. Specific to that particular trial? 20 A. The objective of that trial, yes. 21 Q. Why has Lilly not done any clinical trials to 22 determine whether or not Prozac causes suicidal ideation in 23 humans? 24 MR. MORRIS: I'm sorry. 25 MR. SMITH: Oh, wait. Page 165, the answer. 43 1 MR. MORRIS: Line 18? 2 MR. SMITH: Line 6. 3 MR. MORRIS: Sorry. 4 I don't know in my capacity as director of 5 medical regulatory affairs or worldwide regulatory affairs. 6 Q. Have you ever seen any suggestion that Lilly 7 conduct a clinical trial in humans to determine whether or not 8 Prozac causes suicidality in humans, any suggestion by Lilly 9 employees that such a study be done? 10 A. Well, I think earlier we talked about some 11 potential protocols that followed up to one of these meetings 12 that we talked about this morning that were shared with FDA by 13 Doctor Zerbe, so I don't know if that speaks to your question 14 or not. I've seen that aspect of it. 15 MR. SMITH: At this time, Your Honor, we would 16 offer Plaintiffs' Exhibit 96, which I believe has previously 17 been offered as the February 13th, 1991 memo by Doctor Leigh 18 Thompson. It has previously been offered as 96, if any of the 19 jurors -- you want to wait a second and see if any of the 20 jurors want to -- 21 JUDGE POTTER: Would anyone like another copy of 22 96? I don't know if any of them brought any with you. Raise 23 them up high, how many hands have we got, just two? 24 Have you got two extras, Mr. Smith? 25 MR. SMITH: I've got the original. 44 1 JUDGE POTTER: All right. My sheriff will get 2 the original back from them. Get these two back for me. Get 3 them both back. 4 SHERIFF CECIL: Okay. (Hands document to 5 Jurors Duncan and Fitch). 6 Q. Will you review Exhibit 3 for me, Doctor 7 Talbott? 8 A. All right, sir. 9 Q. Okay. Excuse me. If you were going to do a 10 study in February of 1991, to do that study would the FDA 11 require that Lilly submit to them a protocol of the study in 12 order to do the study? 13 A. I believe that would fall under the IND 14 requirements, yes. 15 Q. And would that protocol have to be approved by 16 the Food and Drug Administration? 17 A. Yes, sir. 18 Q. Even though by February of 1991, Prozac is 19 already approved, an approved drug? 20 A. That's correct, sir. 21 Q. And even though anybody could do a study if they 22 wanted to; correct? 23 A. Well, any individual physician could obtain the 24 drug and do that. 25 Q. As long as they could prescribe the drug? 45 1 A. Yes. Exactly. That's what I was getting ready 2 to say. 3 Q. But if the manufacturer of the drug, Eli Lilly 4 and Company, in February of 1991, wanted to do a clinical 5 trial, they would need to submit a protocol and that protocol, 6 would that have to be approved by the Food and Drug 7 Administration? 8 A. That would be my advice to the company on this; 9 yes, sir, from my understanding. 10 Q. And that's because federal regulations require 11 that as per your interpretation? 12 A. I think specifically, yes, parts of 312 -- 13 21 CFR 312. 14 Q. The point of this study would be, as you 15 understand it as director of medical regulatory affairs for 16 Lilly, would be to determine whether or not that bad 17 experience could be reproduced, that adverse experience could 18 be reproduced by reintroduction of the investigational drug? 19 A. Well, a challenge study is generally a study 20 that is given to evoke a particular adverse event. 21 Q. Okay. 22 A. So I think that's how I would answer your 23 question. 24 Q. Which is basically my question; correct? 25 A. I'm sorry? 46 1 Q. The object is to see the individual reacting in 2 a similar or different manner than they had reacted to the 3 drug previously? 4 A. That's right. That's a good definition of a 5 challenge study. 6 Q. Was that study done? 7 A. I don't know, sir. I don't think so. 8 Q. Did you ever see a protocol drafted by Lilly 9 concerning the design of a study like that? 10 A. That particular one? I don't recall seeing one, 11 sir. 12 Q. Have you ever seen anything approved by the Food 13 and Drug Administration concerning this type of study? 14 A. May I clarify? 15 Q. Uh-huh. 16 A. For Prozac? 17 Q. Yes. 18 A. No, not for Prozac. 19 Q. What's your understanding of the value of that 20 challenge study? Why is that something that would be of 21 value, based on your knowledge as a fellow with a Ph.D. and as 22 the director of regulatory affairs at Eli Lilly and Company? 23 A. I think what I would go back to was the 24 definition I used just a few minutes ago, the challenge study, 25 and that was to see if the administration of a drug would 47 1 evoke a particular adverse event. 2 Q. Would that be of scientific interest? 3 A. Yes. 4 Q. But as far as you know, a study such as that has 5 never been done by Lilly on Prozac? 6 A. No, sir; I don't. I don't know that that study 7 has been done. 8 Q. Wouldn't you know, had there been one? 9 A. I would think so; yes, sir. 10 Q. Has any such challenge study been submitted to 11 any regulatory body but rejected by that regulatory body? 12 A. Not that I'm aware of, sir. 13 Q. Do you know of any regulatory reason why a 14 challenge study such as is suggested by Doctor Leigh Thompson 15 in February of 1991 could not be done? 16 A. Regulatory reason alone? 17 Q. Yeah. 18 A. No. I don't think there would be any 19 regulations that I'm aware of that would prohibit it. 20 Q. Do you know of any reasons why such a study 21 couldn't be done? 22 A. None that really comes to mind, no. 23 Q. The second study that Doctor Thompson mentioned 24 in connection with his February 13th memo is -- and I will 25 quote him -- a prospective study using new instruments to 48 1 measure suicidality in depressed folks randomly given Prozac 2 versus placebo or active comparitor; correct? 3 A. Yes. Depressed folks randomly given Prozac 4 versus placebo or an active comparitor, yes; that's correct, 5 sir. 6 Q. Were you aware in February 1991 that there were 7 new instruments to measure suicidality in depressed folks? 8 A. I don't know, Mr. Smith. 9 Q. Well, did you know what measurements were used 10 during the clinical trials prior to approval by the Food and 11 Drug Administration to measure suicidality? 12 A. No, I don't, sir. 13 Q. Have you seen any articles or scientific 14 publication that measure new measurements to measure 15 suicidality at any time? 16 A. I don't recall any, sir. 17 Q. Do you know whether or not a prospective study 18 using new instruments to measure suicidality in depressed 19 folks randomly given Prozac versus placebo or active 20 comparitor was ever done? 21 A. No, sir. I don't know. 22 Q. Again, if Lilly had done that, would they have 23 had to have done that under a protocol? 24 A. Yes. 25 Q. And would that protocol have had to have been 49 1 submitted to the Food and Drug Administration? 2 A. I believe we have talked -- I'm sorry. Yes. 3 Q. And would that request for approval of that 4 protocol have had to come via your signature as the director 5 of medical regulatory affairs? 6 A. It would have gone through my office; that's 7 correct, sir. 8 Q. And you're not aware of any such request? 9 A. I don't recall any at all, sir. 10 Q. You have never seen any protocol for a 11 prospective study using new instruments to measure 12 suicidality, as far as you know? 13 A. Again, I know there was some discussion between 14 Doctor Zerbe and people at FDA about potential studies. 15 Q. I understand that. 16 A. And whether I saw a protocol or not as part of 17 those discussions, I don't recall. So I can't say yes or no; 18 I just don't recall. 19 Q. You don't know of any studies that came to 20 fruition? 21 A. No, sir. I think I've answered that before, 22 but, no, I don't. 23 Q. And don't know of any protocols that were 24 approved -- 25 A. Not that I'm aware of. 50 1 Q. -- by the Food and Drug Administration? 2 A. No. 3 Q. And you're not sure, but you don't think you 4 know of any protocols that were submitted by Lilly to the Food 5 and Drug Administration concerning that? 6 A. I just don't recall if there were any. 7 Q. The third type of study that Doctor Thompson 8 mentions is probably used fluoxetine as an active comparitor 9 in many of the studies of new antidepressants. It says this 10 would serve as an additional suicidality studies for the FDA; 11 correct? 12 A. That's what it says there; yes, sir. 13 Q. Do you know whether or not Lilly used fluoxetine 14 as an active comparitor in any study of a new antidepressant? 15 And again I'll caution you, Doctor Talbott, to not reveal the 16 names of any other potential medicines being promulgated by 17 Lilly. 18 A. Okay. Thank you. I can't specifically recall 19 any, sir. 20 Q. And, again, especially if Lilly were studying 21 the new antidepressant and if fluoxetine was going to be used 22 as an active comparitor, that would be something where there 23 would have had to be FDA approval for such a study; is that 24 correct? 25 A. That's correct, sir. 51 1 Q. And there would have to be a formal protocol 2 prepared by Lilly? 3 A. And submitted to the agency; that's correct, 4 sir. 5 Q. And you're aware of none? 6 A. None that I recall; no, sir. 7 Q. That has been prepared or submitted? 8 A. I don't recall any. 9 Q. Do you have any knowledge concerning why such a 10 study hasn't been done? 11 A. No, sir. 12 Q. Do you have any knowledge why a prospective 13 study using new instruments to measure suicidality hasn't been 14 done by Lilly? 15 A. No, sir. 16 Q. I think you said earlier this morning that there 17 were several studies that were discussed; among those you 18 talked about Doctor Zerbe's discussion. 19 A. That's correct, sir. 20 Q. And that after the FDA advisory committee 21 meeting in September of 1991 on suicidality, that there was a 22 consensus that there was no need for that type of study; is 23 that right? Is that what you said? 24 A. That was my take of the situation; that's 25 correct. 52 1 Q. Is that still your take of the situation? 2 A. Oh, yes. Yes. 3 Q. It's just not necessary to do those studies 4 because of what was done at the advisory committee meeting in 5 October, September of 1991? 6 A. Not only what was done but what was discussed, 7 the data review, the conclusions reached by the agency and the 8 advisory panel and ourselves. 9 Q. You, as the director of medical regulatory 10 affairs at that time for Eli Lilly and Company, felt that that 11 was sufficient with respect to the issue of Prozac and 12 suicidality? 13 A. Yes, sir. 14 MR. SMITH: At this time, Your Honor, we would 15 offer Plaintiffs' Exhibit 99, which is Exhibit 4 to Doctor 16 Talbott's deposition. 17 JUDGE POTTER: Be admitted. 18 SHERIFF CECIL: (Hands document to jurors). 19 JUDGE POTTER: Marsha, why don't you get the two 20 copies of 96 back before the Plaintiffs forget about it. 21 SHERIFF CECIL: Okay. 22 JUDGE POTTER: And give Mr. Smith the two 96s. 23 SHERIFF CECIL: You want both of them to go to 24 him? 25 JUDGE POTTER: Yes. 53 1 SHERIFF CECIL: (Hands documents to Mr. Smith). 2 Q. We have handed you a document marked Exhibit 4, 3 I believe. Would you read that document for me, please, 4 Doctor Talbott? 5 A. Sure. You want me to read it to myself? 6 Q. Yes. Make yourself familiar with it, and I will 7 probably end up reading it out loud. 8 A. Okay, sir. 9 Q. Exhibit 4 is a memo dated May 15th, 1991, isn't 10 it? 11 A. That's correct, sir. 12 Q. And that is a memo authored by Doctor James 13 Kotsanos, M.D.? 14 A. Kotsanos; that's correct, sir. 15 Q. What was the date again? 16 A. May 15th, 1991. 17 Q. May 15th. The memo is dated about 60 days after 18 this Exhibit 3 we've been talking about where Doctor Thompson 19 is suggesting some studies for the FDA; correct? 20 A. Did you say 60? It would be more like 90, 21 wouldn't it, February to May? 22 Q. Yes. About 90. 23 A. Okay. Yes. And, apparently, you-all have by 24 this time had another meeting with employees of the Food and 25 Drug Administration; correct? 54 1 A. That's what this would indicate; yes, sir. 2 Q. And it says at the FDA meeting -- I assume that 3 was another one of the meetings in Rockville, Maryland, home 4 of the Food and Drug Administration? 5 A. Most likely it would be; yes, sir. 6 Q. And you are an addressee on that memo, are you 7 not? 8 A. Right. 9 Q. You were present at the meeting on May 13th, 10 1991, weren't you? 11 A. I don't recall, Mr. Smith. There may be some 12 other records or indications and I certainly don't recall that 13 I wasn't there, but I don't recall that I was there. 14 Q. Can you tell by looking at the individuals 15 listed on Page 1 of that exhibit that that's -- whether or not 16 that's intended to be a listing of individuals present at the 17 meeting? 18 A. I'm not sure that all these folks would be 19 there. I think that's what you're asking; right? 20 Q. Yeah. 21 A. Does this look like sort of a group that would 22 be there? I don't think so. I don't think all these folks 23 would necessarily be there. 24 Q. The subject of Exhibit 4, the memo dated May 25 15th, 1991 -- 55 1 A. This is Exhibit 4 I'm looking at right now? 2 Q. Yes. -- is, quote, FDA meeting to discuss 3 fluoxetine rechallenge protocol, comma, May 13th, comma, 1991. 4 A. Yes, sir. That's the title. 5 Q. And these are the protocols that we discussed 6 earlier, that in the clinical trial process must be submitted 7 to the Food and Drug Administration in a formal manner; 8 correct? 9 A. Correct, sir. 10 Q. And must be approved by the Food and Drug 11 Administration in a formal manner? 12 A. The protocols? 13 Q. Yes. 14 A. Yes, sir. 15 Q. Now, by that, with that background, if you look 16 at the caption of this memo, it would appear to me that there 17 was a protocol either being drafted or being considered at the 18 time; is that right? Does that -- would that be an accurate 19 interpretation? 20 A. Let's see. FDA meeting to discuss fluoxetine 21 rechallenge protocol. 22 Q. If you just read the caption wouldn't you assume 23 that there was some protocol that was written that was being 24 examined? 25 A. You might come to that conclusion. I guess I 56 1 could offer an alternative and we might go, for example, 2 hypothetical, because, again, I can't recall whether I was at 3 this meeting or not, but we might go there to discuss 4 developing a protocol. 5 Q. The memo says that at the FDA, Lilly agreed to 6 do the following projects, doesn't it? 7 A. Let's see. We're talking on the first page, 8 sir? 9 Q. Yes. 10 A. At the FDA meeting Lilly agreed to do the 11 following projects, colon. Right. 12 Q. One, proceed with the rechallenge study? 13 A. That's correct, sir. That's the heading for 14 One. 15 Q. Do you know if a rechallenge study was ever 16 done? 17 A. I don't know that, sir. 18 Q. Do you know if a rechallenge study protocol was 19 ever drafted? 20 A. No. I don't know whether one was or not. 21 Q. I believe we testified -- you testified earlier 22 that certainly you don't have any recollection of formally 23 submitting a rechallenge protocol to the Food and Drug 24 Administration? 25 A. I believe that's an apt characterization, sir, 57 1 yes. 2 Q. And you don't have any recollection of receiving 3 any formal approval from the Food and Drug Administration 4 concerning a rechallenge protocol? 5 A. I believe that's been my testimony; yes, sir. 6 Q. The third bullet point under Item One says we 7 agreed to have the rechallenge protocol ready to go by 8 September 1st, 1991, doesn't it? 9 A. Let's see here. We're talking the first page, 10 Item Number One? Yes. There are little points there. We 11 agreed to have the rechallenge protocol ready to go by 12 September 1, 1991. That's correct, sir. 13 Q. It also says, "and to provide data after the 14 first quarter, which would provide information on six months 15 of experience, doesn't it? 16 A. Yes, it says that. It does. You read that 17 correctly. 18 Q. It also says in the next sentence, this will 19 allow the Food and Drug Administration -- or he says FDA and 20 Lilly -- to determine if the study was feasible or not and to 21 give a feel for the data we were collecting if patients were 22 enrolled, doesn't it? 23 A. That's a correct reading, sir, yes. 24 Q. Do you know whether or not the rechallenge 25 protocol was ready to go by September 1st, 1991, 58 1 Doctor Talbott? 2 A. No, sir; I don't. 3 Q. Do you know if there was any data collected in 4 the first quarter of 1991, which would provide information on 5 six months of experience in testing this drug in a rechallenge 6 basis on individuals who had been suicidal -- who had had 7 suicidal ideation after being treated with Prozac? 8 A. I really don't understand what he means by this, 9 Mr. Smith. I'm not trying to be difficult, but I don't 10 understand what he means, data after the first quarter which 11 would provide information on six months of experience. I 12 mean, a quarter is three months, six months of experience, so 13 I don't know what he's going after there. So I don't know. I 14 guess to answer your question, I don't know. 15 Q. You haven't seen any data generated in 16 connection with a rechallenge study, have you, Doctor Talbott? 17 A. Not that I'm aware of, sir, no. 18 Q. The second point in that memo says that 19 incorporated the modified scale for suicidal ideation, 20 revised, paren, MSSI, dash, R, close paren, in ongoing and 21 planned U. S. and UK clinical trials. 22 A. That's correct, sir. That's Item Number Two. 23 Did we have a question before us, Mr. Smith? I'm sorry. 24 Q. Is that what the second point says? 25 A. The second point said Item Number Two, 59 1 incorporate the modified scale for suicide ideation, dash, 2 revised, parentheses, MSSI, dash, R, close parentheses, in 3 ongoing and planned U. S. and UK clinical trials, period. 4 Q. Do you know what a modified scale for suicidal 5 ideation is? 6 A. Other than what I can just derive from the words 7 themselves, a modified scale for suicidal ideation, I don't 8 know anything about it, practically; it's a clinical scale, 9 apparently. 10 Q. Apparently -- I think you testified earlier you 11 don't know anything about any scales or measurements of 12 suicidal ideation. 13 A. Yes. I believe I recall that. It was in regard 14 to Exhibit No. 3, Item No. 2, I think. 15 Q. Did you ever see a protocol or any plan 16 submitted to the Food and Drug Administration incorporating a 17 modified scale for suicidal ideation? 18 A. I don't recall any, sir, no. 19 Q. Did you ever see any data or any plan or any 20 proposal from a fellow by the name of Ivan Miller in 21 connection with this? 22 A. No. That name doesn't ring a bell at all. 23 Q. You've never heard of Ivan Miller? 24 A. I don't think so, no. 25 Q. Have you heard the term "validation study"? 60 1 A. Validation study is kind of a general term in 2 science. You have a method -- do you want me to explain it? 3 Q. Please. 4 A. Okay. You have a methodology, whether it's rats 5 or whatever, and you propose this methodology, and then you 6 validate against it an existing standard of some kind. So 7 that's what a validation study means to me. 8 Q. Is that good scientific principle? 9 A. I think so, yes. 10 Q. Do you know whether Lilly ever complied with 11 Item 3, as they agreed to do, in the use of MSSI, dash, R? 12 A. It may take a second. I'll review that 13 paragraph. 14 Q. Sure. 15 A. I don't know that we ever did that, sir. I 16 don't have any information one way or the other. 17 Q. Four indicates that Lilly agreed to do a 18 descriptive study of patients reported to develop intensive 19 violent, suicidal thoughts, doesn't it? 20 A. Give me a second again, Mr. Smith, to read the 21 paragraph. 22 Actually, they're talking about -- talking a bit 23 about a pilot study there. I will just modify it a bit. It 24 looks like we had suggested, after Doctor Stadel had made some 25 input, that we think about a pilot rather than a full-blown 61 1 study. 2 Q. Was there any pilot study done, which you're 3 aware? 4 A. I'm not aware of any, sir. 5 Q. Would a pilot study be a study that would have 6 to be submitted by the Food and Drug Administration by Lilly? 7 A. I would think so; yes, sir. 8 Q. Would a pilot study be a study that would have 9 to be approved by the Food and Drug Administration? 10 A. I would think so, sir. 11 Q. Do you know of any such pilot study submitted or 12 approved by the Food and Drug Administration? 13 A. I don't recall any, sir. 14 Q. The middle paragraph there says Doctor Leber 15 mentioned that it may be worthwhile to determine what the 16 risk, parens, incidents, close paren, is on the development of 17 these symptoms in garden-variety patients created for the 18 first time with fluoxetine versus other agents. Do you see 19 that? 20 A. That's the sentence; yes, sir. 21 Q. Do you know whether or not Lilly ever did any 22 study to determine what the risk is of development of these 23 symptoms in, quote, garden-variety patients treated for the 24 first time with fluoxetine versus other agents, end quote? 25 A. I don't know what Doctor Kotsanos meant by 62 1 garden-variety patients; I'm having trouble with that. So I 2 wouldn't know -- I mean, if I don't know what kind of patient 3 it is, I can't really give you a good answer about whether we 4 ever did a study or not. 5 Q. Do you know if the current German package insert 6 for fluoxetine has been submitted to the FDA? 7 A. The current one, no, I don't know whether that 8 one has or not. 9 Q. Is it Lilly's policy to submit yearly, or 10 anytime, its updated package inserts from other countries to 11 the FDA? 12 A. Not normally, no. 13 Q. What circumstances will a package insert be 14 submitted? 15 A. Usually it's part of a safety update or in 16 pre-approval sorts of documentation, consistent with the 17 regulations. 18 Q. How often are safety updates filed once a drug 19 is marketed in the United States? 20 A. In the United States, Ms. Zettler, it's 21 quarterly for the first three years and then it's annually 22 thereafter. 23 Q. Are foreign-country package inserts routinely 24 submitted with every safety update? 25 A. With post-approval safety updates, not 63 1 necessarily, no. 2 Q. What situation would a package insert from 3 another country be submitted with a post-approval safety 4 update? 5 A. I can't give you an exact instance, but, for 6 example, sometimes the agency will make as a part of their 7 approval conditions the fact that you will provide package 8 inserts for X number of months or X number of safety updates 9 or X number of years, et cetera, and it would be under those 10 conditions. 11 Q. Do you know if they did that in this instance? 12 A. I can't recall. 13 Q. What's the difference between approvable and 14 approval letter? 15 A. Let's track back from approval. Approval is the 16 -- Mr. Smith and I talked yesterday about the New Drug 17 Application being essentially a sponsor's application for 18 marketing rights for a new drug, and so the approval letter 19 grants you those rights and you can start selling the drug the 20 next day. 21 The approvable letter is really at the 99.9 22 percent completion point of the overall review when there are 23 some remaining questions that the agency wants to get 24 concluded as they complete their internal reviews, prepare the 25 documents associated with those, et cetera. So, generally, 64 1 the approvable letter will contain several pages of questions 2 that a firm then is asked to address before the approval 3 letter is finally granted. 4 Q. So the request to submit on package inserts 5 would be contained in the approval or approvable letter? 6 A. It could be in either. It could be in the 7 approvable letter as a part of their final information, or it 8 could be in the approval letter as one of the many conditions 9 of approval. There are always conditions of approval. 10 Q. Are there any limitations as far as what types 11 of information can be submitted to the IND as opposed to what 12 types of information can be submitted to the NDA? 13 A. I don't think that the agency restricts 14 submission, no, to the IND. 15 Q. How about to the NDA? 16 A. I don't believe -- in just trying to page back 17 over the Part 314 regulations I don't believe there's any 18 prohibition against submission in there. 19 Q. Doctor, do you recall yesterday testifying about 20 a rechallenge study being considered by Lilly prior to the 21 1991 product or drug advisory committee meeting? 22 A. As I recall, there was a memo, to use the term 23 -- actually, several memos used challenge, rechallenge, 24 et cetera; yes, ma'am, in that time frame. 25 Q. And it's your recollection that the study was 65 1 dropped after the 1991 advisory committee meeting because of 2 the results of the committee meeting or what was discussed at 3 the committee meeting -- 4 A. Consistent with that, I was going to say I don't 5 know if "dropped" is the right word or not, but reconsidered 6 within that time frame, and because of that reason that's my 7 understanding. 8 Q. The study was not done, to the best of your 9 knowledge; correct? 10 A. That's correct. 11 Q. And the reason it was not done was because of 12 the results or the results of the drug advisory committee 13 meeting held in 1991 -- 14 A. My understanding was -- 15 Q. The drug advisory committee meeting held in 16 1991; correct? 17 A. That's correct. My understanding was that as a 18 result of that, the study was not conducted. 19 Q. Who at Lilly made the decision not to do the 20 study after the 1991 advisory committee meeting? 21 A. I don't know, ma'am. I'm sorry. 22 Q. How about the FDA? Who at the FDA decided that 23 the study didn't need to be done, if you know? 24 A. I don't know. 25 Q. Who would be in charge of making such decisions 66 1 at Lilly? 2 A. At that time? 3 Q. Yes. 4 A. I think Doctor Thompson was the senior clinical 5 expert or clinical officer, if you will. 6 Q. Yesterday, Paul asked you a series of questions 7 about Lilly conducting or participating in studies 8 specifically structured to study the incidence of suicidal 9 ideation and the use of fluoxetine; do you remember that? 10 A. Yes, ma'am; I do. 11 Q. Do you recall any study that Lilly conducted or 12 participated in, where the specific objective of the study was 13 to look at the incidence of violent-aggressive behavior and 14 the use of fluoxetine? 15 A. I don't recall any such study. 16 Q. Before or after 1990? 17 A. No, ma'am. At any time. 18 Q. When the FDA approves a protocol that's 19 submitted to it, how is that approval communicated to Lilly? 20 A. It can be one of two ways. One way, which is 21 the most common way, is that we'll submit a protocol; the 22 agency will then send us back a form with typed-in -- it's a 23 boilerplate with, typed in, on such and such a date, we 24 received your Protocol No. 1, 2, 3 for IND No. 4, 5, 6, and 25 consistent with Part 312 regulations and unless FDA gets back 67 1 to us by -- and it's a date 30 days afterwards -- it says then 2 we're free to start the study. On occasion, as we talk to FDA 3 about other issues we'll say, "Have you got any problems with 4 the protocol that we sent in 21, 22 days ago, you know, for 5 IND 4, 5, 6, 7," and then perhaps by that point then the 6 division will say it's okay to start the trials, or they might 7 say, "We have not completed the review yet, but if we have any 8 problems by Day 30 per our letter of such and such a date, we 9 will let you know." So those are two ways. Most normally we 10 get the paper back, the acknowledgment back from the FDA and 11 we have 30 days on, and then the IND starts. 12 MR. SMITH: At this time, Your Honor, we would 13 offer Plaintiffs' Exhibit 95, which was Doctor Talbott's 14 Exhibit 17. 15 JUDGE POTTER: Be admitted. 16 SHERIFF CECIL: (Hands document to jurors). 17 Q. Doctor, have you had a chance to review Exhibit 18 17? 19 A. Yes. Just give me a second longer, Ms. Zettler. 20 Q. Sure. 21 A. Okay. 22 Q. Do you recognize this exhibit? 23 A. Yes. I believe, again, this is one of my, 24 quote, unquote, four-box exhibits. 25 Q. Okay. It talks about Doctor Laughren initiated 68 1 a call to Doctor Zerbe requesting additional information on 2 the 16 patients who reportedly committed suicide and 1 who 3 reportedly committed a homicide in the summary basis of 4 approval; correct? 5 A. That's correct. 6 Q. Okay. He talks about it there, Doctor Laughren 7 asking for additional information on those cases that he could 8 use in preparation for the advisory committee meeting in 1991; 9 correct? 10 A. That's what the second sentence, I believe, 11 says. 12 Q. A couple of sentences later he says or the -- 13 I'm sorry. The next sentence he states, "I followed with a 14 number of questions first requesting permission to contact 15 Doctor Bruce Stadel regarding his presentation to the advisory 16 committee." Do you see that? 17 A. Yes. 18 Q. And Doctor Stadel is the same Doctor Stadel 19 we've talked about quite a bit in the past day or so about -- 20 who did numerous statistical analyses of data given to him by 21 Lilly, as well as other sources; correct? 22 A. It's the same Doctor Stadel; yes, ma'am. 23 Q. Do you think it was appropriate for Doctor 24 Laughren to give Doctor Zerbe permission to consent or consent 25 to contact Doctor Stadel and ask him about his presentation to 69 1 the advisory committee? 2 A. The way that I interpreted this was that Doctor 3 Zerbe, I think, was following up very much in the same vein 4 that Doctor Laughren had contacted him, and that is to ensure 5 the information was provided. At least that was my 6 interpretation when I read it in my review before coming here 7 and also, once again, when seeing it today. I see it as an 8 information sharing. 9 Q. Don't you think Doctor Stadel would be capable 10 of contacting Lilly and asking for additional information if 11 he needed it? 12 A. Well, he probably would be capable, but 13 understanding the FDA the way I do, we're talking about two 14 divisions now. Laughren is the division of 15 neuropharmacological products, and Stadel is over 16 biostatistics and epidemiology. And I believe the division of 17 neuropharmacological drug products was the division planning 18 the meeting and conducting the meeting. So it would almost 19 require permission from Doctor Laughren, I think, to contact 20 Doctor Stadel, and Doctor Stadel then would almost have to get 21 Doctor Laughren's permission to contact Lilly. Coordinating, 22 I guess, was Doctor Laughren's role in this. 23 Q. Why did Doctor Zerbe go on to say Doctor 24 Laughren consented to emphasize that our questions should not 25 suggest any kind of collaboration? 70 1 A. I hate to say this, but I think you would 2 probably have to ask Doctor Zerbe about that. I wouldn't feel 3 comfortable. 4 Q. Do you know of any collaboration between Doctor 5 Laughren and Eli Lilly on this subject? 6 A. I don't know of any collaboration between Eli 7 Lilly and anybody at the FDA. 8 Q. If Doctor Laughren was in fact collaborating in 9 some way with Eli Lilly on the subject of the September 1991 10 advisory committee meeting or the information that was 11 presented at the meeting, would that be appropriate, in your 12 opinion? 13 A. No. I think my previous comment speaks to that. 14 I wouldn't know of any collaboration between anyone at FDA or 15 at Lilly with anyone on the subject. 16 Q. That's not my question. My question is, if they 17 were collaborating, would that be appropriate? 18 A. I'm not going to answer. 19 Q. Why not? Why aren't you able to answer the 20 question, Doctor? 21 A. I don't think that's a reality. 22 Q. I'm asking you if -- you can consider it 23 hypothetical -- if Doctor Laughren was collaborating with Eli 24 Lilly in preparing for the advisory committee meeting that was 25 held in September of 1991 on the issue of fluoxetine and 71 1 suicidal ideation or violent-aggressive behavior, would that 2 have been appropriate under the FDA regulations? 3 A. My response is simply this: First off, if that 4 had occurred, nobody would write it down in a memorandum for 5 us to be questioned on three years later such as we are now. 6 Q. I wouldn't be surprised. 7 A. Well, with that in mind it would be 8 inappropriate, I agree. 9 Q. It would be inappropriate? 10 A. Yes. 11 Q. You said that the double-blind control study is 12 sort of the gold standard of studies as far as clinical 13 trials? 14 A. My terminology, not FDA's, certainly. 15 Q. In your opinion? 16 A. That's my opinion. 17 Q. That's assuming that the study is being 18 conducted properly, correct, that it remains blinded, for 19 instance? 20 A. That would be implicit; otherwise, it wouldn't 21 be a blinded study. 22 Q. Just because the protocol is set up to require a 23 blind or a double-blind doesn't necessarily mean that the 24 study is conducted adequately or correctly under the protocol, 25 and each individual study could be flawed depending on 72 1 inadequacies about how it was conducted? 2 A. Of any aspect, whether it's blinding of, you mix 3 up the medications, I mean, sure. You plan and you plan 4 properly and then hopefully you execute properly, and then 5 lastly you analyze properly, so a breakdown could occur at any 6 time. 7 Q. So a gold standard can be garbage if it's not 8 conducted and analyzed properly; correct? 9 A. Well, but that was implicit in my saying that 10 that's the gold standard. I'm looking at a study when it's 11 done. I'm saying that it's an adequate and well-controlled 12 study because it was blinded, et cetera, et cetera, and all 13 the caveats I've just implied. 14 Q. Just because it's reported doesn't necessarily 15 mean that it was properly done, though, does it, Doctor? 16 A. Reported where? 17 Q. Anywhere. 18 A. Of course not. 19 MR. SMITH: That concludes the deposition of 20 Doctor Max Talbott, Your Honor. 21 JUDGE POTTER: Okay. 22 Ladies and gentlemen, we're going to take the 23 evening recess, and let me say a few things to you. I know 24 some of you have submitted questions to my sheriff, and 25 oftentimes there's -- sometimes there may be something, you 73 1 know, a question can be asked for some reason or another; 2 other times it may not be the right witness to ask the 3 questions. Like today, we've had nothing but deposition 4 witnesses, and we really can't change their testimony, you 5 know, to add or subtract from it. But I can assure you that 6 I've given all your questions, the ones that are appropriate, 7 to the attorneys and they have either agreed at some time or 8 another to get them answered, or if they don't want to do it, 9 like I did the other day, I will do it. So I just wanted to 10 let you know that those things weren't being ignored. 11 I've got some good news for you. Tomorrow will 12 be a short day. I have something that's going to tie me up in 13 the morning that's out of the ordinary, so we won't start till 14 10:00. The parties try and anticipate when they're going to 15 need evidence, and it's hard to anticipate, you know, two 16 weeks ahead exactly how long things are going to go, but Mr. 17 Smith's office tells me that it's going to be kind of a short 18 day tomorrow, so we'll come in at ten and you-all will be out 19 of here by 12:00 or 12:30 or something like that. And they've 20 also told me they'll have some live witnesses for you next 21 week. 22 I'm going to give you the same admonition I've 23 given you before: Do not permit anybody to speak to or 24 communicate with you on any topic connected with this case, 25 and, of course, don't get any information about it from any 74 1 outside source, including the newspapers or TV or whatever. 2 Do not discuss it among yourselves and do not form or express 3 opinions about it. We'll stand in recess till 10:00 tomorrow 4 morning. 5 (PROCEEDINGS TERMINATED THIS DATE AT 4:26 P.M.) 6 * * * 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 75 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 76 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