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 FRIDAY, OCTOBER 14, 1994 15 VOLUME XV 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 Hearing in Chambers...................................... 4 5 * * * 6 WITNESS: DOCTOR_W._LEIGH_THOMPSON - Continued _______ ______ __ _____ ________ 7 Examination by Mr. Smith................................. 15 8 * * * 9 Hearing in Chambers......................................128 10 Reporter's Certificate...................................143 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 IRVIN D. FOLEY Rubin, Hays & Foley 11 300 South, First Trust Centre Louisville, Kentucky 40202 12 13 FOR THE DEFENDANT: 14 EDWARD H. STOPHER Boehl, Stopher & Graves 15 2300 Providian Center Louisville, Kentucky 40202 16 JOE C. FREEMAN, JR. 17 LAWRENCE J. MYERS Freeman & Hawkins 18 4000 One Peachtree Center 303 Peachtree Street, N.E. 19 Atlanta, Georgia 30308 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 Friday, October 14, 1994, at approximately 8:55 A.M., said 5 proceedings occurred as follows: 6 7 * * * 8 9 (THE FOLLOWING PROCEEDINGS OCCURRED IN ROOM 148) 10 JUDGE POTTER: You-all mentioned there was 11 something we needed to talk about? 12 MR. FREEMAN: Yes, sir. Judge, after 13 yesterday's hearing we went back to the depositions and 14 checked on Exhibit No. 70. First of all, as represented by 15 plaintiffs -- 16 JUDGE POTTER: What is No. 70? 17 MR. FREEMAN: 70 is the article that nobody 18 could identify that Leigh Thompson had never seen, didn't know 19 what it meant or anything else. First of all, in Doctor 20 Beasley's deposition, contrary to what was represented to the 21 Court as being identified by the deposition, it's not 22 identified there. The only witness we've been able to find 23 out it was even shown to was Doctor Zerbe, and Doctor Zerbe 24 said he did not know what it was and had not ever seen it. So 25 we think this should be withdrawn and taken out of the jury 5 1 packet because it was not correct. 2 MS. ZETTLER: It was never given to the jury. 3 MR. FREEMAN: You offered it with the 4 representation -- it went in with the representation that it 5 was connected up. 6 MS. ZETTLER: It is connected up. 7 JUDGE POTTER: I need to go out and get my list. 8 Was it admitted into evidence? 9 MS. ZETTLER: No. 10 JUDGE POTTER: I've got my notes out here. I'll 11 go by my notes. 12 (JUDGE POTTER LEAVES AND RETURNS) 13 JUDGE POTTER: My rough notes would be that it 14 was not introduced into evidence and that you-all could look 15 at the transcript, but I suspect that most happened was kind 16 of a discombobulated... 17 MS. ZETTLER: It wasn't admitted. We never 18 passed it out. 19 MR. FREEMAN: You let him ask questions on it. 20 JUDGE POTTER: And he said, "No, I didn't know 21 about that. Yes, I know about that. I disagree with that." 22 MS. ZETTLER: He went into his long explanation 23 about three different types of treatments, et cetera. 24 JUDGE POTTER: My memory of it would be that the 25 purpose of the cross-examination was that at some point later 6 1 somebody was going to say this is significant, this is the way 2 it is, then they could have him as saying he didn't know about 3 it, or at least he disagreed with it. But my notes are that 4 it is not in evidence. 5 MR. FREEMAN: If that's right, that's one thing. 6 In the second place, I think we need to be very specific about 7 allowing documents to be inquired of a witness when it has not 8 been identified unless we can show the page reference. 9 JUDGE POTTER: Well, we went over this two days 10 ago that I think before a document comes in it has to be 11 authenticated and identified. And, apparently, you-all don't 12 have a problem with authentication very much. 13 MR. MYERS: That's right. 14 JUDGE POTTER: But there is a problem with 15 identification. 16 MR. FREEMAN: Yes, sir. 17 JUDGE POTTER: And, you know, I said let's do 18 something where you get a list -- you know, they mark them, 19 give them to you two days ahead of time, you don't object the 20 second day, then we're agreed that it's authentic and we know 21 what it is. And both of you didn't want to do that because 22 you wanted to retain your flexibility, you thought things were 23 working out. You know, I may have to do that -- force it on 24 you just to bring some order to it because everybody agrees -- 25 I mean, in a way I don't understand how you can agree 7 1 something is authentic until you know what it is: It's the 2 will of Mr. Foley; it's Mr. Foley's diary; it's Mr. Foley's 3 social calendar. Just admitting that this is something 4 written by Mr. Foley -- 5 MR. FREEMAN: With no author, we couldn't admit 6 to anything. 7 JUDGE POTTER: We agree it's authentic, it's a 8 piece of paper written by Mr. Foley in a certain day, but 9 you've got to identify what it is. That one is particularly 10 unself-identifying because it doesn't have dates or an author 11 on it. I don't know whether there was a cover sheet missing 12 or whatever. We'll just keep going the way we are and, you 13 know -- 14 MS. ZETTLER: That was the basis of your ruling 15 that we couldn't pass it out to the jury, Judge. There's 16 really no issue here. That thing never got to the jury. 17 JUDGE POTTER: At the end of today we'll sit 18 down and plan out next week, and do you think Mr. Thompson is 19 going to take most of today? Is that where we are? 20 MR. SMITH: (Nods head affirmatively). 21 JUDGE POTTER: And you're going to bring him 22 back on Monday? 23 MR. FREEMAN: (Nods head affirmatively). 24 MR. SMITH: Wait. I thought he was going to 25 Brussels. 8 1 MR. FREEMAN: He was, but I'm going to keep him 2 here. 3 MR. SMITH: Absolutely not. I've got my expert 4 scheduled first thing Monday. You told me that -- 5 JUDGE POTTER: Wait just a second, Mr. Smith. 6 He is entitled -- I think what he told you was that he would 7 be here through Friday, he was scheduled to go to wherever 8 next week. And that was said to you more into if you're going 9 to use him, use him this week; I can't guarantee -- I'm not 10 planning to have him here next week. If you take him up 11 through 1:00 today -- or the other alternative is we will just 12 go a full day. But I don't think you can go till 1:00 and say 13 he can't get his cross-examination in. So, I mean, we'll just 14 have to decide. You finish and then we'll decide whether to 15 go longer -- I mean, you're not looking at that much on your 16 fellow, are you? 17 MR. FREEMAN: Sir? 18 JUDGE POTTER: Timewise on Mr. Thompson, what 19 are you looking at? 20 MR. FREEMAN: I'm looking at half a day to three 21 quarters. 22 MR. SMITH: Then I'll have redirect. Judge, the 23 reason I put Doctor Thompson on, we subpoenaed Doctor Thompson 24 to appear. Because he's an out-of-state witness we subpoenaed 25 him. 9 1 JUDGE POTTER: I thought that's what you were 2 going to do when you were not making your points about "Where 3 is Mr. Smith, is he in Indianapolis?" You were going to get 4 him on the freeway going to Alabama with all these other 5 people. 6 MR. SMITH: And when I subpoenaed Doctor 7 Thompson, Mr. Freeman advised me -- the reason I subpoenaed 8 Doctor Thompson was because Mr. Freeman advised me that he was 9 going to be out of the country for a couple of weeks. I went 10 ahead and subpoenaed him, and I said when we subpoenaed him -- 11 we said, "We will work with you on your schedule." And then 12 Mr. Freeman advised me that Doctor Thompson was going to be 13 out of town beginning Monday. That required me to put him on 14 as an adverse witness. They have said he's coming back. I 15 certainly have scheduled my witnesses and put Doctor Thompson 16 on on the representation that they would bring him back and 17 put on their case with him when they got him back. 18 JUDGE POTTER: Okay. Well, now, I don't know 19 what that representation was. I was in a hallway or something 20 where you-all wanted to make sure that they understood Doctor 21 Thompson -- you could call him even though he probably wasn't 22 on the list and -- in the hallway when he was advising you 23 that he was going to be out of town next week and the week 24 after. And, see, I have no idea. Were you going to put him 25 on for three hours and he takes him an hour and a half? 10 1 MR. FREEMAN: Nor did I. And I certainly never 2 agreed that I wasn't going to examine him. 3 MR. SMITH: I thought you were going to bring 4 him back later on. 5 MR. FREEMAN: I can't leave this cold, really. 6 MR. SMITH: I wouldn't have put him on had you 7 not represented to me you were bringing him back. 8 MR. FREEMAN: We had him ready to go Wednesday 9 morning, also, and you did other things. 10 JUDGE POTTER: In all candor, that is correct. 11 I mean, it was a little vague. And I didn't know whether you 12 were doing it just to needle Mr. Freeman or not about exactly 13 when you were going to call him. 14 MS. ZETTLER: We're trying to put our case on, 15 Judge. 16 JUDGE POTTER: I understand, but there was a 17 thought at the beginning of the week that he would be on 18 Wednesday. And I'm not criticizing you-all and I don't get 19 into it, but I do -- my ruling would be that you have called 20 the witness and he says, "Judge, I want to do my 21 cross-examination;" he's entitled to cross-examine the 22 gentleman. Now, if your-all's understanding was that he would 23 do his direct and there would be no cross-examination -- 24 MR. SMITH: That was my understanding. 25 MS. ZETTLER: And we also anticipate our case 11 1 being in before he gets back from Brussels; that's why we put 2 him on now. We would have waited and gone till later if he 3 wasn't going to be gone for two weeks. 4 JUDGE POTTER: I don't understand what the 5 problem is. 6 MS. ZETTLER: We anticipate our case being in by 7 the time he gets back from Brussels, so we made adjustments 8 around his schedule. We subpoenaed him. We could have 9 insisted that he stick around for a couple of weeks. Instead, 10 we're trying to accommodate them. So now Mr. Freeman is 11 telling us that he's going to take up part of our case in 12 chief to put on his case when he should be required to bring 13 him back during his own case because he's just going to get up 14 there and spew company policy. 15 JUDGE POTTER: Which he's doing... 16 MR. SMITH: Pretty good now. 17 JUDGE POTTER: That's why I asked him what are 18 we talking, an hour and a half? 19 MS. ZETTLER: We're trying to accommodate them, 20 too, Judge. 21 JUDGE POTTER: You are. But I think they're 22 entitled to cross-examine every witness you call. And if 23 there was some misunderstanding they weren't going to 24 cross-examine... But if you kept him here for two weeks and 25 examined him, he would have still been cross-examining him 12 1 during your part of the case. 2 MR. SMITH: We wouldn't have called him when we 3 did, might not have called him at all had we not been told 4 Doctor Thompson won't be back until your case is over. That's 5 why we had to put him on at this time. 6 JUDGE POTTER: All right. I understand. What 7 about this, Mr. Freeman? My ruling is not going to change, 8 but I will tell you this, that if -- I mean, can't you limit 9 yourself to, like, two hours because he's getting his policy 10 in during their part of the case. You know, if they really 11 get up and object a lot, a lot of what you're going to take 12 him over is probably going to be asked and answered. I 13 understand your thing, you don't want this just to come in and 14 lay there without a response. 15 MR. FREEMAN: Judge, I think I have a right to a 16 thorough examination of him and I can't do it in two hours. 17 Plus, you've told the jury they're going to be gone at 12:00 18 or 12:30 today, and I don't want to irritate them and be the 19 one that's holding them up. 20 JUDGE POTTER: Even if he comes back on 21 Monday -- I mean, I'll just tell you, my notes on Doctor 22 Thompson are about that much out there because things have 23 been going over and over and over and over, and there's very 24 little in dispute. He's an excellent professional PR person. 25 You know, we'll just take it up when you do your 13 1 cross-examination, but maybe you could tell them that you'll 2 keep it to two hours, and then they won't object and you can 3 put on your dog-and-pony show and he gets to go to Brussels, 4 because there really is very little in dispute. You don't 5 need to rehabilitate him. He does a fine job himself. Okay? 6 But my ruling is that they do have a right to 7 cross-examine every witness you call after you call the 8 witness, and if there was a misunderstanding, maybe things 9 that important need to be put on the record. 10 MR. SMITH: That's what I'm going to say. In 11 that case, Your Honor, we're going to not be able to make any 12 kind of agreements or accommodation with defense counsel 13 without the matter being brought up before the Judge and 14 without a Court Reporter present, because we feel that we've 15 certainly been taken advantage of in connection with this, and 16 we'll not make any accommodations for the -- I mean, just 17 yesterday -- day before yesterday Mr. Freeman came to me and 18 advised me that Doctor Ray Fuller, their neurobiologist, had 19 cancer and asked me, said he was going to start six weeks of 20 chemotherapy and asked me if he could put him on during our 21 case out of order, and I accommodated him. And we scheduled a 22 time for him to come in, and now Mr. Freeman tells me this 23 morning he's not going to bring him in. There will be no 24 more, Counsel, no more agreements made outside the presence of 25 the Judge and outside the presence of the Court Reporter. 14 1 MR. FREEMAN: That's fine. But you'll have to 2 admit that I never said that I was not going to examine Doctor 3 Thompson. Never, never, never. 4 JUDGE POTTER: It was a misunderstanding 5 whichever way it was, and I'm sure both sides believe they're 6 correct in good faith, but I think you-all detected the way I 7 try a case is you-all can make all kind of agreements you 8 want. And I haven't got involved very much in this case 9 pretrial and I may come to regret it, but it comes up, I rule 10 on it and we go on. And the ruling is before me, that if he 11 says I want to cross-examine the witness you called, and I 12 can't say no. 13 You know, I think you-all have gotten along very 14 well, and I really don't believe what's happened today is 15 going to change that. I do think you-all are getting along 16 well. Let's go back out and we'll put on today's proof and 17 maybe Mr. Smith will finish early, you'll get yours in and the 18 problem will go away. 19 (THE FOLLOWING PROCEEDINGS OCCURRED IN 20 OPEN COURT) 21 SHERIFF CECIL: The jury is now entering. All 22 jurors are present. Court is in session. 23 JUDGE POTTER: Please be seated. Ms. Morrison, 24 did you have any trouble with the admonition last night? 25 JUROR MORRISON: No. I didn't have any problem. 15 1 I'm sorry. 2 JUDGE POTTER: You-all have changed seats on me. 3 You're Ms. Morrison. My chart is off. All right. Let me get 4 who everybody is. So I have to put Ms. Morrison over there, 5 and that means you have to be Ms. Shelby; is that right? 6 JUROR SELBY: Selby. 7 JUDGE POTTER: Selby. All right. I'll erase 8 the H in the name. I don't know how I got them out of order 9 because you-all are -- and I can figure out who Mr. Miller is 10 in that scramble. The three of you-all are different than you 11 are on my chart. But, anyway, that Ms. Morrison, did you have 12 any problems? 13 JUROR MORRISON: No, sir; not at all. 14 JUDGE POTTER: Okay. And I take it the rest of 15 you haven't, either. 16 Doctor Thompson, I'll remind you you're still 17 under oath. 18 Mr. Smith. 19 20 EXAMINATION ___________ 21 22 BY_MR._SMITH: __ ___ _____ 23 Q. Doctor Thompson, yesterday we were discussing 24 the protocols which, as I understand it, are the rules and 25 regulations and guidelines for how the investigators were -- 16 1 who were hired by Lilly were to perform the clinical trials; 2 is that correct? 3 A. Yes, sir. 4 Q. And I believe -- I don't know if you have it 5 before you, sir -- we have already introduced Plaintiffs' 6 Exhibit 49, which was Slater's Exhibit 12. 7 May I approach the Witness, Your Honor, to show 8 him the document? 9 JUDGE POTTER: Sure. 10 A. I don't think I have it. 11 Q. All right. (To Ms. Zettler) Do we have a copy 12 of that? 13 Here. We got an extra copy. 14 A. Thank you, sir. 15 Q. This was a relatively early protocol, 16 apparently, that was written in connection with the IND 17 Protocol No. 14, is it not? 18 A. Yes, sir. 19 Q. It's attached to a cover letter from Doctor 20 Slater to Doctor Gosenfeld in Los Angeles, California; 21 correct? 22 A. Yes, sir. At the Brentwood V.A. 23 Q. Turn with me to the protocol itself and let's 24 talk about this a little bit. Under the heading, it's headed 25 up "A Control Study for the Treatment of Major Depressive 17 1 Disorders with Fluoxetine"; correct? 2 A. Yes, sir. 3 Q. And when we see that No. 110140 out there beside 4 anything like this, is that the number to which Prozac was 5 being referred to at the time? 6 A. Yes, sir. When we make new molecules we assign 7 a number to them as a code internally so we can keep them 8 straight, and that was its number at this time. 9 Q. All right. The document identifies who the 10 investigator is going to be in this case? 11 A. Yes, sir. 12 Q. Maybe not always will the protocol actually list 13 the name of the investigator; is that right? 14 A. Often if it's going to have many investigators, 15 it just indicates that they'll all be psychiatrists or some 16 other qualification, and then you select them as you go out 17 and find them. 18 Q. All right. It appears that under Paragraph 3, 19 the control agents is going to be imipramine; is that right? 20 A. Yes, sir. 21 Q. Which was another or is another existing 22 tricyclic antidepressant? 23 A. Yes, sir. 24 Q. And imipramine works, I believe you said 25 earlier, Doctor Thompson, on a number of neurotransmitters as 18 1 opposed to just serotonin? 2 A. That's exactly correct. 3 Q. This under Paragraph 4 mentions fluoxetine, 4 placebo and imipramine; is that right? 5 A. Yes, sir. 6 Q. So some of the patients were going to get 7 Prozac; some of the patients were going to get a placebo, 8 which is a capsule that looks similar to the other capsules 9 but really has no active ingredients; is that right? 10 A. Most people call it a sugar pill. 11 Q. All right. And then imipramine is the tricyclic 12 antidepressant? 13 A. Yes, sir. 14 Q. And you're going to compare the actions of those 15 two medications with a placebo to determine the different 16 actions of the drugs; is that right? 17 A. Yes, sir. 18 Q. Under Paragraph 5 and Paragraph 6 -- 5A and B, 19 actually, you're defining the group that you're going to 20 study; is that right? 21 A. Yes, sir. 22 Q. And there is separate criterias for inclusion 23 and separate criterias for exclusion in Paragraph B; is that 24 right? 25 A. Yes, sir. 19 1 Q. And to be excluded in this study individuals who 2 were a serious suicidal risk? 3 A. That's one of the 16 exclusions. Can I explain 4 what that means? 5 Q. What serious suicidal risk means? 6 A. Yes, sir. 7 Q. Okay. I guess so, if you'd like to. 8 A. Well, if you notice, the first inclusion 9 criteria is that this is going to be an outpatient study, so 10 people are going to be not hospitalized. It's unethical -- I 11 would consider it unethical -- to do a study outside of the 12 hospital in somebody that the physician judged needed to be 13 hospitalized for any reason, but certainly one of the reasons 14 would be that you're afraid the person is about to kill 15 themselves. So this doesn't mean -- and remember I wasn't at 16 Lilly in '79, but the way it's used today does not mean that 17 you're not putting into the study people who are thinking of 18 suicide or even committing acts of suicide. What you're 19 saying is if some patient told you that they were seriously 20 considering it, they'd bought the gun, they planned when to do 21 it, they knew exactly how they were going to shoot themselves, 22 almost any physician would put that kind of patient in the 23 hospital and, therefore, you wouldn't put them in an 24 outpatient study. 25 Q. You feel that explains it adequately? 20 1 A. Well, adequately for now. 2 Q. The serious suicidal risk is one of, as you say, 3 16 criteria for exclusion? 4 A. Yes, sir. 5 Q. The question of whether or not a patient was a 6 serious suicidal risk was something that was going to be 7 determined in the investigator's discretion; is that right? 8 A. Yes, sir. 9 Q. If you'll turn with me to Page 6 of the 10 protocol, under Paragraph 4 there, it is talking about the 11 study period. Under 4 it says, on Page 6, "Given the 12 investigator's opinion, it is necessary chloral hydrate .5 13 grams or 1 gram may be given for sleep. Administration of 14 chloral hydrate will be recorded in the case-report form." 15 B says, "If a patient complains of agitation, 16 the dose of study drug should be reduced and the patient may 17 receive diazepam at the investigator's discretion. This 18 should be entered on the case-report form." Correct? 19 A. Yes, sir. 20 Q. So if a patient in the study was having problems 21 sleeping, the investigator could administer chloral hydrate, 22 which is a sleeping medication? 23 A. Yes, sir. 24 Q. And if a patient was complaining of agitation on 25 the study, the investigator had a couple of options. Number 21 1 One, he could reduce the dose of the study drug; right? 2 A. Yes, sir. 3 Q. And here the study drug is fluoxetine? 4 A. No, sir. The study drug is placebo, fluoxetine 5 and imipramine. 6 Q. It says study drug, does it not? 7 A. No, sir. 8 Q. The words say study drug, don't they, Doctor 9 Thompson? 10 A. The study drug means whatever drug from this 11 protocol the patient is assigned to. And some of the 12 patients, as you said, would be on placebo and some would be 13 on imipramine and some would be on fluoxetine. This 14 instruction absolutely does not say that you only do that for 15 patients on Prozac. That's not what it says. 16 Q. The drug under study in this protocol is Prozac, 17 is it not, Doctor Thompson? 18 A. No, it's not. If you go back and look at the 19 clinical trial materials there are three drugs under study, 20 one of them is placebo, which we think of as a sugar pill, one 21 is Prozac and one is imipramine. All three of those are study 22 drugs. 23 Q. The title of the protocol says "A Controlled 24 Study of the Treatment of Major Depressive Disorders with 25 Fluoxetine Hydrochloride." That's why I thought that maybe 22 1 the study drug would be referring to fluoxetine, since the 2 name of the study is "A Controlled Study of the Treatment of 3 Major Depressive Disorders with Fluoxetine." 4 A. I understand why it's easy to make that mistake, 5 but if you think through it, if in fact the investigator knew 6 which drug the patient was on, it wouldn't be a blinded study. 7 So they wouldn't have any way of carrying out this instruction 8 if it were interpreted by them the way you interpreted it, 9 meaning you only reduce the dose of fluoxetine. 10 The second thing is, if you treated that group 11 of patients different from the other group of patients, then 12 you wouldn't know whether their responses were due to 13 fluoxetine or the fact that you had introduced some other 14 variable that treats them differently. 15 Q. In the administration of sleeping pills like 16 chloral hydrate and sedatives or anti-anxiety agents like 17 diazepam, you are introducing another agent other than the 18 study drug, whatever that study drug might be, are you not, 19 Doctor Thompson? 20 A. Yes, sir. 21 Q. So it says here under B, "If a patient complains 22 of agitation, the investigator may do two things," or both, I 23 guess. It says, "He may reduce the dose of the medication or 24 he may add diazepam at the investigator's discretion." 25 Correct? 23 1 A. Yes, sir. Diazepam is Valium. 2 Q. And Valium is -- is that a tranquilizer or a 3 sedative? 4 A. I'd rather use a third word, if you don't mind, 5 an anxiolytic, a drug that reduces anxiety. Because most of 6 us use tranquilizer to mean the very powerful drugs that you 7 use in psychosis and sedative to mean like chloral hydrate 8 that just have the effect of putting you to sleep. And so 9 this is sort of in between; it's a drug that relieves anxiety, 10 although, it also tends to put you to sleep, but it's not a 11 drug you'd use in a psychosis as a major tranquilizer. 12 Q. Well, is diazepam a benzodiazepine, Doctor 13 Thompson? 14 A. Yes, sir. Yes, sir. 15 Q. Under -- on Page 7 here, under 9, Criteria for 16 Discontinuing Drug, Item D says that the drug may be 17 discontinued if serious risk of suicide develops, does it not? 18 A. Yes, sir. 19 Q. Item 12 indicates that there will be statistical 20 analysis plans; is that right? 21 A. Yes, sir. 22 Q. And it says -- the second sentence of Item 12 23 says, "Data will be analyzed by appropriate statistical 24 methods by Eli Lilly and Company," does it not? 25 A. Yes, sir. The methods mean massaging. 24 1 Q. Did I ask you that question, Doctor Thompson, 2 whether methods meant massaging? 3 A. I was trying to explain what was meant here, and 4 the plural on method was very important. 5 Q. You want to explain that methods there mean 6 massage; is that what you're saying? 7 A. Yes, sir. 8 Q. Should we mark that out and maybe put massage in 9 its place there? 10 A. You can put it in parentheses, at least. 11 Q. That's going to be done by Eli Lilly and 12 Company, the statistical massaging, not by the investigator; 13 correct? 14 A. Yes, sir. 15 Q. And I'll try to be a little briefer with these, 16 Doctor Thompson, but I just want you to identify a couple 17 other protocols. Can you identify -- 18 A. This appears to be IND Protocol 19. 19 Q. Yes. And is that a protocol used in a Prozac 20 study? 21 A. Yes, sir. That's what it says. 22 MR. SMITH: We would offer Exhibit 104, Your 23 Honor. 24 MR. FREEMAN: No objection. 25 JUDGE POTTER: Be admitted. 25 1 SHERIFF CECIL: (Hands document to jurors). 2 Q. Exhibit 104 is another protocol that was used in 3 the Prozac studies, is it not? 4 A. Yes, sir. 5 Q. It's IND Protocol No. 19, and the investigator 6 on that study was Doctor Louis Fabre down in Houston, Texas. 7 A. I think it's Fabre, but whatever. 8 Q. Under Paragraph 5 -- on Paragraph 3, it looks 9 like this is -- the only other control agent is placebo? 10 A. Yes, sir. 11 Q. In other words, there's not another 12 antidepressant being tested with this drug? 13 A. That's correct. 14 Q. In this case? 15 A. In this protocol. 16 Q. In this protocol under 5 on Page 1, Selection of 17 Treatment Groups, where we define who's going to be in and 18 who's going to be out of the study, this is also an outpatient 19 study, is it not? 20 A. Yes, sir. 21 Q. Do you know, Doctor Thompson, the number of 22 outpatient studies that were done on depression versus the 23 number of inpatient studies that were done on depression in 24 the Prozac trials? 25 A. Well, do you mean -- we've had several hundreds 26 1 of protocols at this time. Do you mean just in the NDA or 2 since the NDA? In the NDA, to my knowledge, there was either 3 one or two studies that had hospitalized patients. 4 Q. All right. So that would be those studies that 5 had been completed or were in existence before September 1983? 6 A. Yes, sir. 7 Q. And then -- okay. So of those depression 8 studies that Lilly submitted to the FDA that they contended 9 supported safety and efficacy of the drugs, there were one or 10 two that were inpatient studies? 11 A. And they may not have had all inpatients, but 12 they didn't say it had to be only in outpatients. 13 Q. And how many outpatient studies were there at 14 that time, Doctor, in depression? 15 A. You know, I know we had studies numbered up 16 to 29, but some of those were in normal volunteers. So I 17 think in the original NDA there were somewhere in the range of 18 three dozen total protocols, some, again, in healthy 19 volunteers. 20 Q. Could we use maybe the figure approximately 25 21 were outpatient studies and 1 or 2 were inpatient studies? 22 A. That's the best of my recollection, in that 23 ballpark. 24 Q. Under the inclusion criteria on Page 2, it has 25 Paragraph 5 there, Hamilton Psychiatric Rating Scale for 27 1 Depression, HAM-D, score of at least 20. 2 A. Yes, sir. Should we define what that means, 3 because it's a little arcane? 4 Q. Well, as I understand, the Hamilton Psychiatric 5 Rating Scale for Depression was one of the scales that was 6 being used to measure whether or not patients, A, were 7 depressed to enter the study and, B, whether they improved, 8 stayed the same or got worse during the study; is that right? 9 A. That's correct. 10 Q. And there are just I guess arbitrary numbers 11 assigned to whether or not a patient is depressed by virtue of 12 a score on the HAM-D? 13 A. Well, that takes a little more explanation. 14 People that are thought not to have any mood disorder at all, 15 no depression, will have scores -- these are a series of 16 questions that a psychiatrist is asked about does the patient 17 have a sleep disorder, are they thinking of suicide and so 18 forth. 19 Q. I tell you what, Doctor Thompson. I have that 20 and I'll introduce that in about ten minutes. If you want to 21 defer talking about that, we can go ahead and get through 22 these protocols and we'll get a sample HAM-D so we can all 23 look at it at the same time. 24 A. Let me add just one thing about the score of 20. 25 That's the generally accepted minimum score on the scale, 28 1 which qualifies as moderate to severe depression. 2 Q. All right. That was going to be what I was 3 going to ask. Does 20 -- or did 20 at that time on the HAM-D 4 scale, was that sort of a break-even point for moderate to 5 severe; is that right? 6 A. Yes, sir. 7 Q. So a minimally depressed patient would not be in 8 the study? 9 A. That's correct. 10 Q. But a moderately depressed patient would be in 11 the study, as would a major depressed patient in this study? 12 A. Well, the words actually are moderate or severe. 13 It's all major depressive disorder. 14 Q. All right. This protocol under B in exclusion 15 criteria also excludes serious suicidal risk, does it not? 16 A. Yes, sir. 17 Q. Item 4 under B? 18 A. Yes, sir. 19 Q. This study also under 8 excludes concurrent 20 administrations of other psychoactive drugs, including 21 lithium, does it not, on Page 2B8? 22 A. Oh, I'm sorry. Eight. Yes, sir. 23 Q. If you turn to Page 6, it's also got a Page 8 in 24 the upper right-hand corner of the page, under 4, Medications 25 Under the Study Drug? 29 1 A. Yes, sir. 2 Q. This is identical to Protocol No. 14, is it not, 3 in allowing chloral hydrate for sleep and benzodiazepines for 4 anxiety or agitation? 5 A. Well, let me call your attention to a subtle but 6 very important difference, and that is that 4C actually uses 7 the word "should be reduced" and as I recall the former 8 protocol said "may," and this is a command. 9 MR. FREEMAN: Objection. They both say should. 10 JUDGE POTTER: Mr. Freeman, the Witness can 11 handle his own questions -- or, actually his own answers. 12 Go ahead, Mr. Smith. 13 Q. Under Page 7, 009 in the top right-hand side of 14 the page, it talks about D, treatment-related dropouts. 15 A. Yes, sir. 16 Q. Do you see that? 17 A. Yes, sir. 18 Q. Under 9, the Criteria for Discontinuing the 19 Drug? 20 A. Yes, sir. 21 Q. And it's Item 3 there says that, "Those patients 22 in whom a serious suicidal risk of suicide develops should be 23 discontinued from the study"? 24 A. Yes, sir. 25 Q. And, again, on Page 8, Page 010 in the upper 30 1 right-hand corner of the page under 12, Statistical Analysis 2 Plans, the last sentence there says that, "Data will be 3 analyzed by appropriate statistical methods by Eli Lilly and 4 Company." Correct? 5 A. Yes, sir. 6 Q. And, again, when we say appropriate statistical 7 methods in that sentence, could we also put in parens, 8 massaged, Doctor Thompson? 9 A. Well, that's my slang word for it. 10 Q. Finally, Doctor, we have the Exhibit 105, which 11 is -- can you identify that as IND Protocol No. 27, which was 12 another study in connection with Prozac for depression? 13 A. Yes, sir. That's what it seems to be. 14 MR. SMITH: We would offer Plaintiffs' Exhibit 15 105, Your Honor. 16 MR. FREEMAN: No objection. 17 JUDGE POTTER: Be admitted. 18 SHERIFF CECIL: (Hands document to jurors). 19 Q. For identification purposes, Doctor Thompson, 20 Exhibit 105 is IND Protocol No. 27, and this was a 21 multi-center study, and there's been testimony concerning this 22 protocol and there will be testimony concerning this protocol 23 in the future. Can you identify this as Protocol No. 27? 24 A. Yes, sir. 25 Q. This is also an outpatient study, is it not? 31 1 A. Yes, sir. 2 Q. This also is a study that requires patients to 3 score at least 20 on the HAM-D on Page 3? 4 A. Yes, sir. 5 Q. It excludes individuals with serious suicidal 6 risk? 7 A. Yes, sir. 8 Q. Under Item 13, it excludes individuals who are 9 engaged in the regular use of psychotropic drugs, including 10 lithium, does it not? 11 A. Yes, sir. 12 Q. On Page 8, under 3 at the bottom of the page, it 13 allows chloral hydrate or flurazepam for sleep, does it not? 14 A. Yes, sir. 15 Q. But on Page 9, apparently, the protocol states 16 that no other psychotropic drugs are permitted during the 17 study; is that right? 18 A. Yes, sir. 19 Q. Which would probably mean, by reading the 20 protocol, that benzodiazepines or diazepam or things of that 21 nature should be administered during the trial? 22 A. Well, I think flurazepam is considered to be a 23 benzodiazepine; it's chemical structure is a benzodiazepine. 24 It says you can use chloral hydrate or you could use 25 flurazepam, but you can't use anything else that works in the 32 1 brain. 2 Q. All right. On Page 12, this statistical 3 analysis plan, this also indicates the data will be analyzed 4 by Eli Lilly and Company, does it not? 5 A. Yes, sir. 6 Q. (Hands document to Witness). 7 A. Thank you. 8 Q. Doctor Thompson, Exhibit 123 is a HAM-D 9 questionnaire, is it not? 10 A. Yes, sir. This is the 21-question version. 11 Q. And this has been, in fact, filled out by an 12 investigator or someone on the investigator's staff actually 13 during the Prozac clinical trials, it appears? 14 A. I can't disagree with that. The protocol number 15 is HCAB and I think that's one of the fluoxetine protocols. 16 Q. And the patient's name, of course, has been 17 marked out to protect the patient's privacy? 18 A. I hope so. 19 Q. Is this the HAM-D depression scale that we've 20 been referring to earlier? 21 A. Yes, sir. The one thing I think we ought to be 22 careful about is that infrequently in Lilly studies we've used 23 other subsets of this. There's an 18-question version and I 24 think there's actually a longer version than the 21, but this 25 is the one that's been used in all of the major protocols. 33 1 This is the scale that when we say HAM-D, this is almost 2 always the scale that we're talking about. 3 Q. This has 21 questions? 4 A. Yes, sir. 5 Q. We would offer Plaintiffs' Exhibit 123, Your 6 Honor. 7 MR. FREEMAN: No objection. 8 JUDGE POTTER: Be admitted. 9 SHERIFF CECIL: (Hands exhibit to jurors). 10 Q. While the Sheriff is passing that exhibit out, 11 the HAM-D scale is one that was relied on heavily by the 12 scientists at Lilly as being indicative of the safety and 13 efficacy of Prozac, is it not? 14 A. Yes, sir. 15 Q. The HAM-D scale here has 21 different sets of 16 questions, does it not? 17 A. Yes, sir. 18 Q. Or areas of inquiry? 19 A. Yes, sir. 20 Q. The purpose of the HAM-D questionnaire is to 21 rate whether or not a patient is depressed, Number One; 22 correct? 23 A. Yes, sir. That's correct. 24 Q. And then you can follow that HAM-D -- you can 25 administer that test on a serial basis and by looking at the 34 1 total scores get some measure of whether or not the patient is 2 getting more or less depressed; correct? 3 A. Yes, sir. 4 Q. In other words, if you'll look down at the 5 bottom of Page 2, this one is actually scored, is it not? 6 A. Yes, sir. 7 Q. And that person has a score of 28? 8 A. Yes, sir. 9 Q. And that would mean that they would be 10 depressed? 11 A. They would have moderate or severe major 12 depressive disorder; yes, sir. 13 Q. And if this study was administered in two 14 weeks -- the same test was administered in two weeks and they 15 had a score of 35, then two weeks later the score was 40, is 16 it reasonable to assume that that is at least one measure that 17 the patient might be getting more depressed? 18 A. Yes, sir. 19 Q. Consequently, if the patient's score was 28 on 20 the first time, then the second visit it was 20, the third 21 visit it was 18, the next visit it was 18, we could make the 22 assumption that that patient's depression is getting better? 23 A. We can say it's getting better but, as you know, 24 the criteria that we generally used for response in a patient 25 was that they had to have a score reduced to half of the 35 1 baseline score. And most people would say for a real pure -- 2 in other words, the person's gotten over their depression, the 3 score ought to go down to 7; some people even say 3. 4 Q. Okay. So if I'm not depressed, my score would 5 probably be between seven and three? 6 A. It would certainly be less than seven. If 7 you're more than seven, you've got more mood dysfunction than 8 a person who is thought not to have any psychiatric problems. 9 Q. This is a test for depression, is it not, to 10 measure depression? 11 A. Yes, sir. It measures a whole bunch of symptoms 12 that we say are part of the disease which we call depression. 13 Unfortunately, this isn't quite as precise as finding a bug 14 and saying you have an infection with this bug. As you know, 15 it's a little imprecise. 16 Q. But this is sort of a test that is used and 17 relied on generally in the psychiatric community, is it not? 18 A. This is by far the best accepted test in the 19 United States and in the U. S. dominant part of the world. 20 Q. That test covers 21 separate items, does it not? 21 A. Yes, sir. 22 Q. And there is one item only on that test that 23 inquires specifically into suicidality, isn't there? 24 A. Specifically into thoughts or acts of suicide, 25 yes. 36 1 Q. And that's Item 3? 2 A. Yes, sir. 3 Q. Out of the 21 questions; right? 4 A. Yes, sir. 5 Q. Yesterday, Doctor Thompson, we were talking 6 about an Exhibit 85 and 86, the efforts that were made to 7 investigate the postmarketing reports of suicidality and 8 violent-aggressive behavior? 9 A. Yes, sir. 10 Q. And you say you had 21 -- 20 people in the 11 postmarketing area analyzing each and every one of these 12 reports; is that right? 13 A. If you give me one second, let me pull out the 14 second one of those. I have the first one. 15 Q. Eighty-five and eighty-six. 16 A. I remember what you said to be correct, but, 17 interestingly, I only have 86. I don't seem to have a copy 18 here of 85. But I remember what you said, you said it 19 correctly. 20 Q. This has got my scribbling on it, Doctor, but 21 let me show it to you so I can -- so you can be sure and have 22 your recollection refreshed. 23 A. Yes, sir. What you said was correct. 24 Q. All right. Twenty people Lilly was going to go 25 out -- you were concerned about the financial future of Lilly 37 1 and the future of Prozac as a drug by virtue of these 2 postmarketing reports and were doing everything you could to 3 investigate this matter; correct? 4 A. I said financial and our scientific reputation, 5 but that's what I said. That's correct. 6 Q. All right. In all this investigation of 7 postmarketing reports, suicidality or violent-aggressive 8 behavior, did you ever find one instance where it was the 9 opinion of you or any of the scientists at Eli Lilly and 10 Company that the act of suicide, suicide attempts or the 11 violent-aggressive behavior was indeed related to and caused 12 by the ingestion of Prozac? 13 A. Now, you've asked me several questions; one was 14 in my opinion and the other was the opinions of anybody at 15 Lilly, 30,000 people. Can I answer them separately? 16 Q. Well, okay. Let's first ask what your opinion 17 is. And to get to that, let me -- just let me take you 18 through it, okay, because you said I asked too many questions. 19 I'm going to ask one at a time. 20 Did you, Doctor Thompson, ever talk to a person 21 who was complaining of feelings of suicide or feeling violent 22 or aggressive as a result of taking Prozac? 23 A. No. 24 Q. Did you ever talk to a physician who reported to 25 you -- who was reporting that they had a patient who was 38 1 becoming suicidal or violent aggressive on Prozac? 2 A. On Prozac while taking it or after taking it, 3 yes. 4 Q. You talked to physicians who had had that 5 reported to them by their patients? I'm talking about the 6 treating physician. 7 A. I'm talking about the treating physician. 8 Whether it was their own impression or whether it was reported 9 to them by the patient I can't remember, but, yes, I talked to 10 physicians who called and said, "I have this patient," they 11 described it, part of it was suicidality, and they asked 12 questions about our data. Yes, sir. 13 Q. Did you ever ask any of those physicians who 14 were actually treating those patients if they felt like in 15 their opinion that suicidality or violent-aggressive behavior 16 was being caused by Prozac? 17 A. Absolutely. 18 Q. Did any physician that was actually treating a 19 patient ever report to you personally that that physician felt 20 like the Prozac was causing the suicidality or the 21 violent-aggressive behavior? 22 A. No, sir. 23 Q. Did you ever -- how many physicians would you 24 say you talked to that were actually treating patients who had 25 had this reported to them by their patients? 39 1 A. Where suicidality was at least a part of what we 2 were talking about, not necessarily the primary part, at least 3 a half a dozen. 4 Q. Six? 5 A. Yes, sir. 6 Q. Would it have been more? 7 A. It's somewhere around a half dozen, sir. 8 Q. Now, you've not talked to a patient but you have 9 talked to some of the patients' doctors; right? 10 A. No. That's not correct and that's not what I 11 said. I have talked to patients. I have not talked to a 12 patient who called because -- in any way related to 13 suicidality, but I did not say that I had never talked to a 14 patient. 15 Q. I'm not trying to play games with you, Doctor 16 Thompson. My question is: Have you talked to a patient, a 17 person taking Prozac, that has related to you that they felt 18 like this Prozac was causing them to become suicidal or 19 violent aggressive? 20 A. No, sir. 21 Q. All right. You talked to patients before, 22 certainly. You're a physician. 23 A. No. In addition to that, patients taking Prozac 24 have specifically called to talk to me about Prozac, including 25 side effects, but not specifically suicidality. 40 1 Q. All right. But you say that you have talked to 2 maybe approximately six physicians in the United States who 3 have had reports from their patients that they were becoming 4 suicidal or violent aggressive on Prozac? 5 A. Yes, sir. 6 Q. And it's your testimony here that none of those 7 six physicians reported to you that it was those physicians' 8 opinion that the reason the patient was becoming suicidal or 9 violent aggressive was because of the ingestion of Prozac; is 10 that right? 11 A. That's correct. I'm very sure that I asked each 12 of them because that's a part of our safety reporting 13 procedure. So if the person telling me about an adverse event 14 says, "I think it's caused by," I always record that and that 15 stays in our records. So I'm sure that I asked the question, 16 and I'm sure that on this particular issue none of them said 17 that in their opinion it was causally related. 18 Q. All right. Let's go to the next step because 19 you are the chief scientific officer of Lilly. You have other 20 duties other than monitoring postmarketing experience with 21 Prozac, but there are individuals, physicians at Eli Lilly and 22 Company that do that on a regular basis, are there not? 23 A. Yes, sir. 24 Q. And, specifically, the names of some of those 25 psychiatrists at Lilly that do that are Doctor Charles 41 1 Beasley? 2 A. Yes, sir. 3 Q. Doctor John Heiligenstein? 4 A. Yes, sir. 5 Q. Doctor Dan Masica? 6 A. Dan Masica is not a psychiatrist, he is an 7 internist, but he was responsible for -- at one time he was 8 director of the division at Lilly, the medical group that 9 handles neuropsychiatric drugs. 10 Q. And Doctor David Wheadon? 11 A. Doctor David Wheadon. 12 Q. Was a psychiatrist at Lilly who also did that? 13 A. Yes, sir. 14 Q. Any other psychiatrists who did that at this 15 point in time? 16 A. Remember we're talking about a long span of time 17 when you're talking about Prozac, so certainly you had, before 18 I came there, they were already doing that -- well, 19 postmarketing experience. I'm sorry. You're restricting it 20 to just after it was marketed? 21 Q. Yes. And I'm restricting it to psychiatrists at 22 this time. 23 A. Doctor Bennett I think had retired by then. 24 Doctor Lemberger was certainly -- is not board certified in 25 psychiatry, but is a professor of psychiatry; he certainly was 42 1 involved. And I really think that I need to add a little 2 explanation. Anybody at Lilly -- 3 Q. Well, my question -- I'm going to broaden my 4 question, Doctor Thompson. My question simply is give us the 5 names of the psychiatrists that were employed by Lilly at 6 Lilly in Indianapolis who were talking to, on a regular basis, 7 physicians or patients who were alleging or raising the 8 question of whether or not those patients were becoming 9 suicidal or violent and aggressive on Prozac. 10 A. Well, you'd have to include Doctor Tollefson, 11 who came later. Doctor Wernicke is a neurologist; remember 12 they're combined boards of neurology and psychiatry. Then 13 we've had more psychiatrists added recently, Doctor Pande and 14 others. So there's actually a whole collection. 15 Q. Have any of those psychiatrists told you that 16 they have talked to physicians who have reported that they 17 felt they had a patient or patients who had become suicidal on 18 Prozac? 19 A. Yes, sir. 20 Q. They have told you that they have indeed talked 21 to physicians whose opinion it was that the patient was 22 becoming suicidal as a result of taking Prozac? 23 A. Well, they either talked to me as we're talking 24 or they wrote it down in the adverse-event reports. 25 Q. Were there any instances where the psychiatrists 43 1 at Eli Lilly and Company advised you as chief medical officer, 2 or in your other capacity as group vice-president, that they 3 had talked to physicians who had reported to them that these 4 physicians' opinion was that they had patient or patients 5 becoming violent aggressive on Prozac? 6 A. I don't remember the violent aggressive. I do 7 remember the suicidality, which, as you've pointed out, is 8 inward violence. In terms of outward violence, which I think 9 is what you meant by that question, I don't specifically 10 recall that from my own knowledge. 11 Q. So is it your testimony here, Doctor Thompson, 12 that, in fact, it has indeed been reported to you that Lilly 13 has had calls from physicians in this country who have 14 reported to Lilly that it was their opinion that patients were 15 becoming suicidal because they were taking Prozac? 16 A. Yes, sir. 17 Q. Once you got that report, did you personally, 18 the chief scientific officer, call that physician who was 19 reporting that to you? 20 A. Me personally? 21 Q. Yes, sir. 22 A. No. 23 Q. Did you request that the psychiatrists follow up 24 to talk with that physician who was reporting this again? 25 A. Now, that, I have to answer with an explanation 44 1 because you phrased it as psychiatrists, who are a key part of 2 our follow-up system but not the only part. So I wrote the 3 procedures to say what the follow-up would be, and part of 4 that was under the responsibility of the physicians assigned 5 to Prozac, most of whom were psychiatrists. But the actual 6 calls might be made by clinical pharmacists or nurse 7 specialists in what we call the drug epidemiology unit who 8 would then report to the psychiatrist what they've learned in 9 the follow-up. So, again, I'm not trying to play games, I'm 10 just trying to be precise. Did I tell psychiatrists it was 11 their job and only their job to call, no. Did I set up a 12 system whereby somebody would follow up, somebody with medical 13 credentials under the direction of mostly psychiatrists, but 14 not 100 percent psychiatrists, absolutely. 15 Q. All right. And so there was investigation -- 16 further investigation made concerning those reports where the 17 physicians felt like Prozac was causing the suicidality? 18 A. Well, we follow up on any serious event, sir. 19 So as part of that constellation, absolutely. 20 Q. All right. Was there ever a situation where 21 someone at Lilly had confirmed that physician's opinion that 22 Prozac was indeed causing that particular patient to become 23 suicidal? 24 A. Your question is, did they confirm that that was 25 the opinion of the physician treating the patient, yes. 45 1 Q. All right. Did the scientists or psychiatrists 2 or any of the doctors or personnel at Lilly confirm that that 3 physician's opinion was indeed correct? 4 A. There were instances in which for the purpose of 5 foreign regulatory reporting under the CIOMS rules, 6 psychiatrists at Lilly checked a box that said it was possibly 7 related to Prozac; yes, sir. 8 Q. So, by that, are you saying that Lilly did in 9 fact confirm that the physician's opinion that was treating 10 the patient was correct and that Prozac was indeed causing 11 that suicidality? 12 A. No, sir. 13 Q. Do you dispute that any of these physicians were 14 indeed correct when they attributed the patient's suicidality 15 to the ingestion of Prozac? 16 A. Well, because we're talking about a highly 17 technical area, let me say that for the purposes of foreign 18 regulatory reporting, although I didn't do it, I would have no 19 problem with checking the box that says possibly related 20 because anything is scientifically possible. That's 21 different, however, than the tone of your question which is 22 saying that they confirmed the impression of the physician. 23 The physicians by and large wouldn't use the technical term of 24 possible versus probable versus definite, but those are the 25 terms that are very important in reporting adverse events 46 1 outside of the United States. 2 Q. Doctor Thompson, I'll repeat my question and see 3 if I can get an answer this time. Do you dispute here as the 4 Lilly chief scientific officer in front of this jury that 5 Prozac did cause suicidality in those patients reported by the 6 physicians as being causally related to the ingestion of 7 Prozac? 8 A. Do I dispute that it's causally related? The 9 answer to that is, yes, I dispute that there's any creditable 10 scientific evidence that Prozac in any patient has caused as a 11 causal relationship suicidality; yes, sir. 12 Q. All right. So when the physicians have called 13 and said, "I think it's related to Prozac," your opinion is 14 that they are wrong? 15 A. They are wrong because I now have the benefit 16 from a great deal of data and they were looking at a single 17 patient. 18 Q. They were looking at the patient, weren't they? 19 A. They were looking at the patient; that's 20 correct. 21 Q. They knew the patient, didn't they? 22 A. Yes, sir. They knew the patient. 23 Q. They could have been a psychiatrist that had 24 been treating that patient for two years; correct? 25 A. Yes, sir. 47 1 Q. They could have been a general practitioner that 2 might have delivered that patient at birth and followed that 3 patient's general medical care for 30 or 40 years; correct? 4 A. And maybe delivered the patient's parents. 5 Absolutely. They knew the patient very well. 6 Q. And it was their opinion that Prozac was causing 7 the suicidality, but you as the chief scientific officer, 8 because you have more data, dispute that that physician is 9 right? 10 A. That's exactly what I said. 11 Q. All right. 12 (OFF THE RECORD) 13 Q. Can you identify Plaintiffs' Exhibit 87, Doctor 14 Thompson? 15 A. Yes, sir. This is an E-mail -- a Lilly E-mail 16 message which was originated by me. I'm the last signature. 17 It includes a message from Doctor Heiligenstein addressed to 18 me and some other people who were carbon copied, which then 19 around it, both at the front and the back, have my addition to 20 that. I'm sorry it's confusing, but the middle part is what 21 came to me from Doctor Heiligenstein; the top part is what I 22 sent to massacre it out and the signature at the bottom shows 23 that I was the person who put that front part on. 24 Q. This is an in-house Lilly document? 25 A. Yes, sir. September 14th, 1990. 48 1 Q. As far as you know, when you authored this 2 document and when Doctor Heiligenstein authored this document, 3 it was for just internal use; is that right? 4 A. Yes, sir. 5 Q. We'd offer Plaintiffs' Exhibit 87. 6 MR. FREEMAN: No objection, Your Honor. 7 JUDGE POTTER: Be admitted. 8 SHERIFF CECIL: (Hands document to jurors). 9 JUDGE POTTER: Ladies and gentlemen of the jury, 10 while she's passing that out, don't sit there and suffer if 11 you can't hear. They're closer to me; they're facing me. 12 JUROR HIGGS: The red light is not on his mike. 13 MR. SMITH: It's showing as red. 14 JUDGE POTTER: Thank you for trying to solve the 15 problem, Mr. Higgs. 16 JUROR HIGGS: Usually that light is kind of 17 eyeballing us. The batteries must be low. 18 JUDGE POTTER: Raise your hand, make us get it 19 it right. Don't sit there and suffer. Okay? 20 Go ahead, Mr. Smith. 21 MR. SMITH: I'm just trying to remain calm, 22 that's why I'm not talking loud. But I'll try to talk a 23 little louder and still remain calm. 24 Doctor Thompson, why don't -- now that the jury 25 has this document actually in front of them, why don't you 49 1 give them the explanation you were giving them earlier so they 2 can understand how this document works. 3 A. Well, in our E-mail system, at the very top you 4 see the date and the time that's put on by the computer that 5 the last message in this train of messages is recorded. And 6 that was a message to Doctors Masica, Zerbe, et cetera, and 7 from Comments down to the little dash line that says Forwarded 8 Message is the message that came from me, and that's indicated 9 -- you have to go all the way to the back. It says "End of 10 forwarded messages, Leigh Thompson RVAX." The Research Vax 11 Computer. So that's the part that I added. Now, in the 12 middle is the original message that I'm now forwarding. So 13 the September 14, 1990, at 07 -- looks to me like 07:30 to me 14 and carbon copied to four other people -- I'm sorry. That's 15 when I began the forwarded message. The one of September 13 16 at 17:50, the day before, was the one that was addressed by 17 Doctor Heiligenstein to me and the others. 18 Q. All right. So actually on September 13th, 1990, 19 you did indeed receive the bottom of the first page, right, 20 where it says to Thompson, Leigh? 21 A. Yes, sir. 22 Q. All of the second page? 23 A. Yes, sir. 24 Q. And all of the third page up to where it says 25 "End of forwarded message." Is that right? 50 1 A. Yes, sir. That's correct. 2 Q. You got that on September 13th, 1990, at 3 approximately 17:50? 4 A. Yes, sir. 5 Q. What you did was, is you responded on September 6 14th, 1990, at 7:31 in the morning? 7 A. Yes, sir. 8 Q. And when you were responding back, what you did 9 is you just picked up this earlier message and shot that back 10 with your response; is that right? 11 A. Yes, sir. 12 Q. So that everybody would know what you were 13 talking about, so everybody would have exactly in front of 14 them what the subject was? 15 A. Yes, sir. 16 Q. Now, in order to get things in chronological 17 order, it helps to look, in fact, at the second message, 18 because you referred to why you had originally -- you were 19 getting the first message on September 13th, 1990; right? 20 A. Yes, sir. 21 Q. You were at that time fixing to make a 22 presentation to the board of directors at Eli Lilly and 23 Company? 24 A. Yes, sir. 25 Q. And you had been for some time reviewing some 51 1 material, some slides and things of that nature? 2 A. I had been preparing the slides and reviewing a 3 whole bunch of data and information. 4 Q. And you had prior to September 13th, 1990, had 5 discussions with Doctor Beasley, Doctor Heiligenstein, Doctor 6 Masica and Doctor Wheadon; is that right? 7 A. And others. 8 Q. Concerning the subject of the slides and 9 presentation? 10 A. Yes, sir. 11 Q. And you used a term up on the third line of the 12 September 14th message in parentheses there you say, "The 13 verbatims are just for Mr. Wood"? 14 A. Yes, sir. 15 Q. They're in parentheses. You say, "The verbatims 16 are just for Mr. Wood"? 17 A. Yes, sir. 18 Q. Is it verbatim or verbatim? 19 A. I have no idea. 20 Q. Kind of like tomato/tomato. What is that, 21 verbatim? 22 A. There were two different kinds of materials that 23 I was preparing: one was a set of 35-millimeter slides that I 24 would actually use to make a verbal presentation to the board; 25 the second thing was I had summarized what I thought were the 52 1 key points to go over with the chairman of the board, Mr. 2 Wood. So the verbatims in this case -- because it can mean 3 different things. What it meant was a series of bullet points 4 to say, "Here's what I'm saying. Here's what I think it 5 means." 6 Q. Verbatims in here then means key-point 7 summaries? 8 A. Yes, sir. 9 Q. And the Mr. Wood that's referred to is the Mr. 10 Wood who was chairman of the board of Eli Lilly and Company at 11 that time? 12 A. Yes, sir. 13 Q. The same Mr. Wood that's referred to back in 14 that 10 milligram or 5, 20, study back in 1985 where he 15 canceled that study; correct? 16 A. Everything except the word "canceled" is 17 correct. 18 Q. All right. Now, look at the bottom of Page 1 19 where it says Verbatim 4, which would be the last paragraph 20 there; correct? You see that? 21 A. Yes, sir. 22 Q. Now, what this is, is this is a statement that 23 Doctor Heiligenstein, one of the psychiatrists, is making, is 24 it not? 25 A. Yes, sir. Well, it says "we," it probably 53 1 reflects more than his own opinion. 2 Q. The document is authored by Doctor 3 Heiligenstein, but he's probably talked with some of the other 4 psychiatrists or scientists there at Lilly? 5 A. Yes, sir. I believe so. 6 Q. He says there under Verbatim 4: "We feel that 7 caution should be exercised in a statement that, quote, 8 suicidality and hostile acts in patients taking Prozac 9 reflects the patient's disorders and not a causal relationship 10 to PZ," end quote. Correct? 11 A. PZ means Prozac. Yes, sir. 12 Q. All right. So the verbatim that you were going 13 to present to the board of directors by virtue of being in 14 quotes says -- must have said suicidality and hostile acts in 15 patients taking Prozac reflect the patient's disorders and not 16 a causal relationship to Prozac; is that right? 17 MR. FREEMAN: Objection. The Witness previously 18 testified that the verbatim is for Mr. Wood, not for the 19 board. 20 JUDGE POTTER: Go ahead, Mr. Smith, with that. 21 A. The question is correct, as that was probably 22 the exact words on a verbatim. The verbatims, as we've talked 23 about before, were only for Mr. Wood, not for the board, and 24 the reason for that was my style is to present data to the 25 board rather than conclusions. In an abbreviated fashion, I 54 1 was briefing Mr. Wood on, in essence, what I thought the key 2 points were that would come out of that discussion. I 3 didn't -- I don't have a script when I give a talk. 4 Q. All right. But Mr. Wood was the chairman of 5 that board of directors? 6 A. Yes, sir. 7 Q. And the verbatim for Mr. Wood said that the 8 suicidality and hostile acts reflects the patient's underlying 9 disorder and not a causal relationship to Prozac? 10 A. That's what I've written; yes, sir. 11 Q. But what Doctor Heiligenstein, the psychiatrist, 12 says is, we feel caution should be exercised in a statement of 13 that nature, does he not? 14 A. That's exactly what he says. 15 Q. He goes on to explain, "Our physician letter 16 summarizes experience to say" -- no. It says, "Postmarketing 17 reports are increasingly fuzzy and we have assigned, 'yes, 18 reasonably related', on several reports." Correct? 19 A. Yes, sir. 20 Q. In other words, Doctor Heiligenstein was telling 21 you that he as a psychiatrist working at Lilly had marked 22 "yes, reasonably related," to reports of suicidality and 23 hostile acts in patients taking Prozac; correct? 24 A. Yes, sir. But the meaning of that is not clear 25 unless you read it in the context of how we handle 55 1 adverse-event reporting outside the United States. 2 Q. I'm just reading what is written there in black 3 and white, Doctor Thompson, and there's not a word there about 4 outside the United States reporting, is there? 5 A. There isn't the word there, sir, but, again, the 6 context of this is explicit to outside of the United States 7 reporting, and you will misinterpret the words if you don't 8 understand the context in which Doctor Heiligenstein was using 9 them. 10 Q. Well, we've taken Doctor Heiligenstein's 11 deposition. He's in Indianapolis, is he not? 12 A. That's where his office is. I don't know where 13 he is today, either. 14 Q. But if he doesn't come here, we'll read his 15 deposition and we'll get his impressions of what he was 16 referring to then; right? 17 A. Excellent. Excellent. 18 Q. Don't you think that would be the best evidence, 19 since he authored that, Doctor Thompson? 20 A. Yes, sir. Yes, sir. 21 Q. Turn to Page 2. In the middle of the page right 22 there before those marks are there that black kind of box; do 23 you see that? 24 A. Yes. 25 Q. Do you see where it says Page 5? 56 1 A. Yes, sir. 2 Q. He says -- Doctor Heiligenstein also reports to 3 you under Suicidal Thinking and Clinical Trials, "You may want 4 to note that trials were not intended to address the issue of 5 suicidality. Also in Paragraph 2, patients were excluded who 6 were serious suicidal risks." Correct? 7 A. Yes, sir. 8 Q. Do you agree, Doctor Thompson, that the Prozac 9 depression clinical trials were not intended to address the 10 issue of suicidality? 11 A. No, sir. 12 Q. You disagree with Doctor Heiligenstein when he 13 makes that statement? 14 A. I disagree at this time; at that time it was a 15 point of debate. 16 Q. Have any physicians reported to you that they're 17 of the opinion that Prozac causes violent-aggressive behavior 18 in humans? 19 A. Now, before we were talking about physicians 20 specifically treating a patient; now you're saying physicians 21 in the general sense, has any physician reported to me that in 22 their opinion, not necessarily their own patients, they think 23 that Prozac -- if you would be willing to put the word "might" 24 or "may" in there, the answer is yes. If you restrict it 25 specifically to a physician telling me, "I think Prozac causes 57 1 violent or aggressive behavior," the answer is no. 2 Q. Can we say has it ever been reported to you, 3 Doctor Thompson, by physicians that they're of the opinion 4 that Prozac can cause violent-aggressive behavior? 5 A. Yes, sir. 6 Q. On how many occasions? 7 A. Once, maybe twice. 8 Q. Tell me about those two occasions, sir. 9 A. They were in large meetings of predominantly 10 psychiatrists where we were talking about all of the aspects 11 of the drug relatively early on after the publication of the 12 Teischer article and after the newspaper discussions of this 13 case in which psychiatrists were asking a number of questions 14 about the data and in which I recall one, maybe two of them 15 said, "Well, isn't it possible that Prozac could in fact in 16 some individual induce this behavior." 17 Q. And two of those psychiatrists indicated to you 18 that they believed, yes, that Prozac could cause 19 violent-aggressive behavior? 20 A. One or two were at least asking the question, 21 since none of us know, were asking the question at that time 22 of could it happen. I was trying to be very conservative in 23 my answer, or liberal. 24 Q. Well, let's get clear here. Did either one of 25 them express -- those psychiatrists express to you that it was 58 1 their opinion that in some instances Prozac could in fact 2 cause violent-aggressive behavior? 3 A. I think I answered that before, because remember 4 I qualified it to say if you're willing to let me say that 5 they said it may or might in their opinion, the answer -- 6 Q. Let's use the word "can." 7 A. Remember I said before, the answer to that would 8 be no. A physician has never come to me and said, "In my 9 opinion Prozac can do this," the answer is no. 10 Q. Was one of those physicians Doctor John H. 11 Greist, M.D.? 12 A. No. I don't think I ever saw Doctor Greist at 13 one of the meetings that I'm describing that I can recall, but 14 I know Doctor Greist. 15 Q. Doctor Greist has testified as an expert in this 16 case by deposition? 17 A. Yes, sir. 18 Q. And Doctor Greist in his deposition testified 19 that he was at some meetings at Eli Lilly discussing the issue 20 of Prozac causing suicidality and violent-aggressive behavior. 21 Do you recall that he was at those meetings? 22 A. Yeah. Where there were discussions of suicide 23 and aggressive behavior, yes. 24 Q. And those would have been when? And it was in 25 connection with Doctor Teischer's article, would that have 59 1 been 1990? 2 A. Well, it certainly began with Doctor Teischer's 3 article and then the reports of this case, the tragedy we're 4 talking about here. 5 Q. Why wasn't this issue raised in 1984 when raised 6 by the German government? 7 A. It was. It was discussed extensively then. 8 Q. With these psychiatrists that you're talking 9 about? 10 A. No, not those particular psychiatrists. It was 11 discussed with the FDA and it was discussed internally with 12 Lilly, and I don't know which outside psychiatrist it was 13 discussed with. In the context of all the adverse events, we 14 went over in great detail. 15 Q. But you can't remember a specific discussion 16 with a specific individual at the FDA concerning the BGA's 17 opinion that Prozac was stimulating and activating with a 18 side-effect profile of suicide? 19 A. No. Now you've gone beyond what we were talking 20 about yesterday, Mr. Smith, because I think you've got to be 21 very careful with that. Yesterday you didn't ask me if we had 22 a discussion with the FDA about activating versus sedating; 23 that discussion occurred and I recall it. What you asked me 24 yesterday was do I recall telling, myself, Paul Leber on the 25 phone about the BGA's concerns, and I told you that I could 60 1 not recall that conversation. 2 Q. All right. Okay. That was '85. Now I'm in 3 '90. Teischer's written the article, everybody's looking at 4 it, Lilly's looking at it, and the issue of violent-aggressive 5 behavior has come up; correct? 6 A. Again, yes, sir. 7 Q. Because inward-directed violence and outward- 8 directed violence, it's valid to look at both of those in 9 connection with this particular side-effect profile of Prozac; 10 correct? 11 A. And any other antidepressant. 12 Q. And you know Doctor Greist -- you say in these 13 discussions in 1990, there was indeed two psychiatrists who 14 expressed to you that Prozac might indeed cause 15 violent-aggressive behavior in humans? 16 A. I want to distinguish because you've included, 17 in essence, two different groups of discussions. The ones 18 that I was talking about, the one or two psychiatrists who 19 asked about "can" or "might" were in outside meetings where 20 Lilly sponsored 100 psychiatrists who were using the drug 21 coming together to talk about their experience with the drug 22 and to present data. That was one set of meetings. Your 23 question referred to inside meetings at Lilly with expert 24 consultants that we brought in. No one -- no one at those 25 meetings asserted that Prozac was a cause of violent or 61 1 suicidal behavior. 2 Q. All right. None of the experts you brought in 3 to Lilly asserted that? 4 A. We went over it in great detail, and remember 5 you held me specifically to "can cause," which is an important 6 point. The answer to that is none of them, to my memory, said 7 Prozac can cause suicidality or violent behavior. 8 Q. And those that did say Prozac can cause 9 suicidality and violent-aggressive behavior were psychiatrists 10 in these larger outside Lilly-sponsored meetings? 11 A. Yes, sir. 12 Q. You do know Doctor John H. Greist, M.D., do you 13 not? 14 A. Yes, sir. 15 Q. Doctor Greist has been designated as an expert 16 by Lilly, but let me read you what he's testified in his sworn 17 deposition and see if this can help refresh your recollection. 18 The Qs are by me, the As are by Doctor Greist, just like you 19 gave Qs and As in your deposition. 20 MR. FREEMAN: Your Honor, we would request that 21 he read the entire portion at which Doctor Greist talks about 22 this rather than just a portion. 23 JUDGE POTTER: Approach the bench. 24 (BENCH DISCUSSION) 25 MS. ZETTLER: Your Honor, if they want to read 62 1 that, they can read it later or any other portion of this 2 deposition, they can read that later. This is our case; we 3 should be able to cross-examine Doctor Thompson any way we 4 please. 5 JUDGE POTTER: Wait. Let me read what we're 6 talking about. Okay. Mr. Freeman, has somebody got the rest 7 of this that you want me to read with this, Mr. Freeman? 8 MR. FREEMAN: She has the transcript. I will 9 show you. 10 JUDGE POTTER: Show on the transcript what 11 additional you want me to read. 12 MS. ZETTLER: He wants to read this here, too. 13 JUDGE POTTER: Mr. Freeman, will you show me 14 what section you want me to read and I'll ask when they ask 15 him if he agrees or disagrees. 16 MR. SMITH: We just handed it to him. I may not 17 read any of it. 18 JUDGE POTTER: She's handling it, Mr. Smith. 19 MS. ZETTLER: Sorry. 20 MR. FREEMAN: It begins on Page 89, Judge, that 21 she's got marked in red here, the top of that idiosyncratic 22 reaction. 23 MS. ZETTLER: If you could keep your voice down, 24 Joe, and not try to influence the jury. 25 MR. FREEMAN: And that's how it's led into. 63 1 JUDGE POTTER: (Reviews document) Okay. Ms. 2 Zettler? 3 MS. ZETTLER: Paul was asking a question and he 4 admitted that he does think that it causes violent-aggressive 5 behavior. Second of all, this is our case. If they want to 6 get up and read that portion to him, let them. 7 JUDGE POTTER: The fact that it's your case -- 8 MS. ZETTLER: This is not the same set-up as 9 reading a deposition. 10 JUDGE POTTER: I understand, but they're saying 11 that -- I don't know what Mr. Smith is going to do, but if he 12 wants the fellow to read this and say does he agree or 13 disagree with it, I'm going to have him include Page 89 along 14 with 90 and 91 because I think that puts the thing in context. 15 MS. ZETTLER: I think we need to get -- we're 16 just not going to read the thing, Judge, because it doesn't 17 need to be in that context. 18 JUDGE POTTER: I can't guarantee -- okay. 19 (BENCH DISCUSSION CONCLUDED) 20 Q. Did you know whether or not it was Doctor 21 Greist's opinion that Prozac could cause violent-aggressive 22 behavior? 23 A. It's my understanding, and I have not talked 24 with Doctor Greist, but I've talked -- 25 Q. Did you know that it's Doctor Greist's opinion 64 1 that Prozac can cause violent-aggressive behavior? 2 MR. FREEMAN: That is a misstatement of Doctor 3 Greist's testimony. 4 JUDGE POTTER: I'm going to sustain the 5 objection. 6 Q. Do you know whether or not Doctor Greist has 7 stated the opinion that Prozac can cause violent-aggressive 8 behavior in some individuals? 9 A. He's addressed that a number of times in the 10 parts of his deposition that I have seen, but I haven't seen 11 his whole deposition. 12 Q. My question simply is: Did you know, Doctor 13 Thompson, that it's Doctor Greist's opinion that Prozac can 14 cause violent-aggressive behavior in some individuals? 15 MR. FREEMAN: That's not an accurate 16 representation. 17 JUDGE POTTER: Objection sustained again. 18 Q. As chief scientific officer of Eli Lilly and 19 Company, have you ever heard Doctor John Greist, M.D., from 20 Madison, Wisconsin, express the opinion that Prozac can cause 21 violent-aggressive behavior in some individuals? 22 A. Heard, no, sir. I haven't talked with Doctor 23 Greist in several years. 24 Q. You do know that Doctor Greist has been hired by 25 Eli Lilly and Company as an expert in this case? 65 1 A. Yes, sir. 2 Q. You do know that Doctor Greist is on the 3 psychiatric advisory board of Eli Lilly and Company? 4 A. I don't know that of my own knowledge, but I 5 would hope he would be. He's a very good psychiatrist. 6 Q. Do you have any basis for disagreeing with 7 Doctor Greist if he has expressed the opinion that Prozac can 8 cause violent-aggressive behavior in some individuals? 9 MR. FREEMAN: Same objection, Your Honor. 10 JUDGE POTTER: Overruled. 11 A. Yes, sir; I do. And we need to very carefully 12 define "can," because used as a scientist I would agree with 13 the assertion; used indiscriminately, I would not agree with 14 the word "can," and I tried to explain that before. Causality 15 is very important. To a scientist, I would say that almost 16 anything is possible, including the possibility that this 17 courthouse will move across the street to the park outside. 18 In quantum mechanics, that's clearly something that's 19 possible. 20 Q. Beg your pardon? I didn't hear what you said. 21 A. Quantum mechanics tells us it's possible that 22 this courthouse will move across the street to the park on the 23 other side of the street. 24 Q. Quantum mechanics? 25 A. Quantum mechanics, quantum physics will tell you 66 1 that that's possible. If I flipped a coin a thousand times 2 and it came up tails a thousand times in a row, I would tell 3 you that it's possible that it would come up heads on the next 4 turn; I wouldn't bet on it, but I would tell you it's 5 possible, because when a scientist says that, he says I can't 6 prove to you that it's impossible. 7 Q. Do you think Doctor Greist was talking about 8 quantum mechanics or do you think Doctor Greist was flipping a 9 coin when he expressed that opinion, Doctor Thompson? 10 A. I was trying to explain how, as scientists, 11 Doctor Greist and I would use the word "possible." And if you 12 want to define "can," as is it possible, I will agree with 13 that because there are very few things in life that I will 14 tell you as a scientist are impossible. 15 Q. Well, do you disagree that in those individuals 16 speaking about whether or not it can or cannot or may or may 17 not, that in those cases where it would occur, Prozac 18 interacts with the neurochemistry and their disorder to 19 produce a violent behavior? 20 A. My answer to you earlier, if you recall, was 21 that there was no creditable scientific evidence that Prozac 22 in anyone causes violent behavior or suicidality, no 23 creditable scientific evidence that it produces that in 24 anyone. But if you ask me is it possible, I'll say 25 absolutely, because I can't absolutely prove to you beyond a 67 1 shadow of a doubt that it's impossible. 2 Q. Well, what if it interacts with the 3 neurochemistry and that individual's disorder to produce that 4 violent behavior? 5 A. Well, I'm sure that it interacts with the 6 neurochemistry of serotonin in the brain; I'm not sure exactly 7 what that has to do with the resulting effects. 8 Q. What if it is causing violent behavior by virtue 9 of its specific serotonin reuptake inhibiting property or 10 direct or indirect result of the inhibition of serotonin? 11 A. Well, I'll quote you again my answer, which is 12 also what the FDA's talk paper says. There is no creditable 13 scientific evidence that Prozac causes, in anyone, suicidal 14 behavior or violent behavior. That's exactly what my 15 statement is. 16 Q. Your Honor, it's twenty till. I'm fixing to 17 change subjects. 18 JUDGE POTTER: Okay. We'll go ahead and take 19 our morning recess. 20 As I mentioned to you-all, ladies and gentlemen 21 of the jury, do not permit anybody to speak to or communicate 22 with you on any topic connected with this trial. Do not 23 discuss it among yourselves and do not form or express 24 opinions about it. We'll take a 20-minute recess. 25 (JURORS EXCUSED FOR RECESS; BENCH DISCUSSION) 68 1 JUDGE POTTER: Let me go over a few of my 2 rulings just so people will understand what I did. Reading a 3 deposition is entirely different from showing somebody a 4 statement or cross-examining them with a prior inconsistent 5 statement. I do believe in certain very limited situations. 6 I can require you to broaden what you show a person or ask a 7 person or give a person when you're preparing to examine the 8 person about a statement. That's entirely different from 9 reading in a deposition. Those are separate rules, but I do 10 think when you give a person -- you know, "I want to show you 11 a statement that you wrote or a letter that you wrote" or 12 "Isn't it true you told Mr. Smith X, Y, Z on such and such a 13 day," I think I can require you to give them more than just a 14 snippet, and that's all I was doing there. He had like three 15 questions before that that set the tone for his answer, and 16 that's all I was doing. 17 I'm going to go back and revisit an earlier 18 ruling that was made this morning. There's a person here in 19 Louisville who has a saying that they're frequently wrong but 20 never in doubt. I kind of am the other way around; I'm always 21 in doubt and I try to be wrong as infrequently as possible. 22 Mr. Freeman, as just a management of the case and it really 23 doesn't have to do with your-all's agreement outside, I am 24 going to limit -- I don't know whether I'm going to do it by 25 time or what I'm going to do, but I am going to limit the 69 1 cross-examination during the plaintiffs' case of Doctor 2 Thompson. He is a well-prepared, able-to-defend-himself 3 expert witness. We're not talking about some person that saw 4 the red light that needs to be rehabilitated before the impact 5 of the direct examination sinks in on the jury and becomes 6 difficult to change through cross-examination. We're talking 7 about a person who has handled himself as if he were being -- 8 he got on his own cross-examination during the direct. And 9 just for the flow of the case and the problems of the case, I 10 am going to limit you in some way, and what I'm thinking about 11 is like two hours, an hour and a half. And you can call him 12 later, but I don't think this guy ought to be used as an 13 opportunity to wheelbarrow your whole case in through him, 14 because Kentucky does have very broad rules about 15 cross-examination. You can cross-examine on any topic, and, 16 you know, if Mr. Smith hadn't called him he would have 17 probably been your lead-off witness. 18 So I don't know if that changes your thinking 19 about how to handle this afternoon or what you're going to do 20 on Monday, but I am thinking about maybe an hour and a half, 21 certainly no more than two hours, just put a limit on it. You 22 do it the way you can, because there's really very little that 23 needs to be cleared up about what he said. I mean, the man, 24 that's his job, and if we need a -- that's why I've spent some 25 time up here looking around. Well, there is a rule that 70 1 allows me to limit the examination of witnesses just to manage 2 the flow of the case. So if that helps you-all work out what 3 you're doing this afternoon or Monday, go ahead and work it 4 out, but even if he comes back on Monday, there will be -- if 5 you were planning on taking half a day to three quarters of a 6 day there would be a very serious limit on doing it, so I just 7 wanted to advise you-all of that. 8 MR. SMITH: If that occurs, Your Honor, would I 9 have the opportunity to redirect Doctor Thompson? 10 JUDGE POTTER: What do you mean, if what occurs? 11 MR. SMITH: If Mr. Freeman elects to go for an 12 hour or an hour and a half or two hours. 13 JUDGE POTTER: Well, you are -- two minutes 14 redirect. I mean, really, there's very little left to be 15 asked on redirect or cross-examination. Okay. 16 (RECESS; BENCH DISCUSSION) 17 MR. SMITH: We're going to go ahead and relent 18 and read what they've asked us to read to Doctor Thompson, 19 Page 89. 20 JUDGE POTTER: You're going to read it and then 21 what? To what purpose? That's part of my problem. I don't 22 really know what this is. 23 MR. SMITH: Ask him whether he agrees or 24 disagrees. 25 JUDGE POTTER: Okay. All right. That's what I 71 1 thought it was going to be. Okay. 2 (BENCH DISCUSSION CONCLUDED) 3 SHERIFF CECIL: The jury is now entering. All 4 jurors are present. Court is back in session. 5 JUDGE POTTER: Please be seated. Doctor 6 Thompson, I'll remind you you're still under oath. 7 Mr. Smith. 8 Q. Doctor Thompson, I have a portion of Doctor 9 Greist's, Lilly's expert, that I want to read to you and ask 10 you if you agree or disagree with Doctor Greist's opinion in 11 this case. All right? 12 A. Yes, sir. 13 Q. And to be fair with you, I had some copies of it 14 but we're going to include one more page. So if you don't 15 mind, I'd like to come over here so I can show you as I'm 16 reading. All right? 17 A. Sure. 18 Q. Go ahead and sit down; I'm just going to read it 19 over your shoulder. Question. These are questions of Doctor 20 Greist, and this deposition was taken September 29th, 1994, in 21 Mr. Stopher's office here in Louisville, Kentucky. All right? 22 It says Doctor Greist was called by the Plaintiffs and was 23 first being duly sworn, was deposed and testified as follows, 24 and these were questions that I was proposing to Doctor 25 Greist. 72 1 A. Yes, sir. 2 Q. On Page 89, it says, "Question: Have you seen 3 reports in the scientific literature of it being reported that 4 individuals have become violent and aggressive while on 5 Prozac? 6 "Answer: I believe I have. Certainly that's a 7 feeling, an opinion that I have. 8 "Question: All right. Do you share that 9 opinion, that it's a side effect of Prozac that individuals 10 can become violent and aggressive as a result of ingestion of 11 Prozac? 12 "Answer: It's my opinion that it's an 13 idiosyncratic side effect." 14 MR. STOPHER: Idiosyncratic. It is my opinion 15 that it's an idiosyncratic side effect. 16 JUDGE POTTER: That is right. 17 MR. SMITH: Do I need -- do I need to -- 18 JUDGE POTTER: Start the question over. 19 Q. "It's my opinion that it's an idiosyncratic side 20 effect of the entire class of antidepressant medication, 21 Prozac amongst them. 22 "Question: Let's limit it to Prozac right now. 23 "Answer: Okay. 24 "Question: So I can get your answer in 25 admissible form. 73 1 "Answer: Yes. 2 "Question: Is it your opinion that Prozac can 3 cause violent aggressive behavior in some individuals?" 4 His answer was yes. 5 "Question: And why is that? What about this 6 medication would cause somebody to become violent and 7 aggressive? 8 "Answer: Probably their underlying disorder, 9 which in some way that we don't understand, Prozac in those 10 cases where it would occur, interacts with their 11 neurochemistry and their disorder to produce a violent 12 behavior. 13 "Question: Let me see if I understand this; 14 that in those individuals who have become violent or 15 aggressive as a result of the ingestion of Prozac, your 16 opinion is that these individuals have become violent and 17 aggressive while on Prozac because Prozac interacts with their 18 neurochemistry and disorder -- underlying disorder to produce 19 violent behavior in that particular individual; is that right? 20 "Answer: Yes. 21 "Question: Obviously, in those instances, 22 Prozac is causing this violent aggressive reaction by virtue 23 of its neurochemical action; is that right? 24 "Answer: Yes. If we -- in the case where we 25 conclude that it's Prozac that did it, yes. 74 1 "Question: Yes? 2 "Answer: Correct. 3 "Question: By virtue of its serotonin-specific 4 reuptake inhibiting property or direct or indirect result of 5 this inhibition of serotonin? 6 "Answer: Correct." 7 Do you agree or do you disagree with Doctor 8 Greist from the University of Wisconsin and from his 9 expertise? 10 MR. FREEMAN: Your Honor, he hasn't read the 11 portion that he even handed to the Court earlier. 12 JUDGE POTTER: He read the part that was marked. 13 Go ahead, Mr. Smith. 14 MR. FREEMAN: He handed to the Court an exhibit 15 that went down to the end of Page 91, and he did not read 16 that. 17 JUDGE POTTER: No. There was a marked portion 18 on that and he read the part that was marked to the Court. 19 Q. My question is, do you agree or disagree with 20 Doctor Greist, Doctor Thompson? 21 A. I agree with some of his assertions and I 22 disagree with some of his assertions. Since there were a 23 whole number of questions and answers, it's very hard for me 24 to say globally yes or no, because the answer is neither yes 25 nor no. 75 1 Q. We'll take them question by question, then, 2 Doctor. 3 A. Thank you, sir. 4 Q. "Question: Have you seen the reports in the 5 scientific literature of it being reported that individuals 6 have become violent and aggressive while on Prozac?" His 7 answer was, "I believe I have. Certainly that's a feeling, an 8 opinion that I have." Do you agree or disagree with that, 9 sir? 10 A. I disagree with that being in the scientific 11 literature. 12 Q. All right. The next question was, "All right. 13 Do you share that opinion that it's a side effect of Prozac 14 that individuals can become violent and aggressive as a result 15 of ingestion of Prozac?" His answer was, "It's my opinion 16 that it is an idiosyncratic side effect of the entire class of 17 antidepressant medications, Prozac among them." Do you agree 18 or disagree with that, sir? 19 A. As long as we understand between us the 20 definition of idiosyncratic I will agree with it, because 21 idiosyncratic means is it scientifically possible. I already 22 testified to the fact that, yes, it is a possibility. 23 Extremely unlikely. 24 Q. Like moving this building across the street to 25 that park over there? 76 1 A. Well, very unlikely, but certainly a 2 possibility. 3 Q. Like flipping a coin a thousand times? 4 A. And the next time coming up the other way; yes, 5 sir. 6 Q. Like moving this building over there? 7 A. That, sir, is what we mean by idiosyncratic. We 8 do not understand it; we do not have an explanation for it; it 9 occurs out of the blue, but it's not impossible. 10 Q. The next question is, "Is it your opinion that 11 Prozac can cause violent aggressive behavior in some 12 individuals." His answer was a straight yes. Do you agree or 13 disagree with that, sir? 14 A. As long as his yes is taken in the context that 15 it could be a possibility as an idiosyncratic reaction, I will 16 agree with him. 17 Q. And I said -- the next question I posed to him, 18 "And why is that? What about this medication would cause 19 somebody to become violent and aggressive?" His answer was, 20 "Probably their underlying disorder, which in some way that we 21 don't understand, Prozac in those cases where it would occur, 22 interacts with their neurochemistry and their disorder to 23 produce a violent behavior." Do you agree or disagree with 24 that, sir? 25 A. I believe that that is a possibility because I 77 1 can't prove that it's impossible. 2 Q. The next question was, "Let me see if I 3 understand this; that in those individuals who have become 4 violent or aggressive as a result of ingestion of Prozac, your 5 opinion is that these individuals have become violent or 6 aggressive while on Prozac because Prozac interacts with their 7 neurochemistry and disorder -- underlying disorder to produce 8 violent behavior in that particular individual; is that 9 right?" His answer was yes. Do you agree or disagree with 10 Doctor Greist's opinion to that question -- answer to that 11 question? 12 A. I agree that that, like almost everything else 13 you could possibly think of, is possible. I disagree to the 14 extent that I believe there to be no creditable scientific 15 evidence that Prozac in any individual has caused violent or 16 aggressive behavior or suicidality. 17 Q. Well, maybe I'm confused, because right here I 18 asked, "And why is that? What about this medication would 19 cause somebody to become violent and aggressive?" His answer 20 was not possibly, "Probably their underlying disorder, which 21 in some way that we don't understand, Prozac in those cases 22 where it would occur, interacts with their neurochemistry and 23 their disorder to produce a violent behavior." Correct? 24 Isn't that what he said, probably? 25 A. That's what he said. 78 1 Q. Don't you think there should probably be some 2 warning given to physicians in this country that Prozac 3 probably does cause violent aggressive behavior in some 4 individuals, Doctor Thompson? 5 A. Absolutely not. 6 Q. All right. Let's go back real quickly to 7 Exhibit 87. Do you have it before you, sir? 8 A. Yes, sir. 9 Q. There down at the bottom of Page 1, Doctor 10 Heiligenstein says, "Postmarketing reports are increasingly 11 fuzzy, and we have assigned, 'yes, reasonably related', on 12 several reports." Correct? 13 A. Yes, sir. 14 Q. And the statement that he was criticizing was, 15 quote, suicidality and hostile acts in patients taking Prozac 16 reflect the patient's disorder and not a causal relation to 17 Prozac; correct? 18 A. He was saying we should be cautious. We feel 19 that caution should be exercised in a statement, yes. 20 Q. Because they have assigned "yes, reasonably 21 related" on several reports of suicidality and hostile acts 22 while on Prozac; right? 23 A. And that the postmarketing reports are 24 increasingly fuzzy. 25 Q. Right. Now, he said this to you before you made 79 1 your presentation to the board, did he not? 2 A. Yes, sir. 3 Q. All right. Can you identify what's been marked 4 as Plaintiffs' Exhibit 88, sir? 5 A. It says it's the minutes of regular meeting of 6 the board of directors of Eli Lilly and Company, and going 7 down it says that occurred on September 17th, 1990. 8 Q. And that's the meeting where you made your 9 presentation, is it not? 10 A. I think so. 11 Q. And the second page is the minutes of those 12 meeting of the board of directors of Eli Lilly and Company, is 13 it not? 14 A. It seems to be. It doesn't look like the whole 15 minutes and it's not signed, but they are attached. 16 Q. Well, I'll represent to you that it's those 17 portion of the minutes of the meeting of the board of 18 directors having to do with Prozac. Obviously, we weren't 19 given the entire minutes of this corporation because it 20 involves sensitive matters involving other business matters in 21 the corporation; do you understand that, sir? 22 A. I understand that. 23 Q. All right. We would offer Plaintiffs' Exhibit 24 88, Your Honor. 25 MR. FREEMAN: No objection. 80 1 JUDGE POTTER: Be admitted. 2 SHERIFF CECIL: (Hands exhibit to jurors). 3 Q. The first page of Exhibit 88 identifies this as 4 the Meeting of the Board of Directors of September 17th, 1990; 5 correct? 6 A. Yes, sir. 7 Q. And that's when you made your presentation on 8 this issue of whether or not Prozac causes suicidal behavior 9 or violent aggressive behavior there? 10 A. One of many presentations to the board. 11 Q. The minutes reflect that the chairman then 12 requested Doctor W. L. Thompson to enter the meeting to 13 discuss statistics regarding the occurrence of suicide and 14 suicidal ideation in the United States and the data on those 15 phenomena as reported from Prozac clinical trials in the 16 marketing experience; correct? 17 A. Yes, sir. 18 Q. And you did do that, did you not? 19 A. Yes, sir. 20 Q. The minutes reflected that you stated that 21 epidemiology studies demonstrated that suicides, inhibited 22 suicide and suicidal thoughts are common in depressed 23 patients; correct? 24 A. Yes, sir. 25 Q. It says Doctor Thompson -- the last sentence 81 1 says, "Doctor Thompson also indicated that in the view of the 2 epidemiology studies, the number of postmarketing 3 spontaneous-event reports of suicides and suicidal acts have 4 not been of unusual frequency in relation to the large number 5 of patients who have been treated with Prozac. Doctor 6 Thompson concluded by stating that suicide, suicidal acts and 7 suicidal thoughts, therefore, more probably reflect the 8 patient's underlying disorder and not a causal relationship to 9 Prozac," end quote. Is that correct, sir? 10 A. It's correct and it's based on the sentence that 11 you left out. 12 Q. I'll read the entire thing. I didn't intend to 13 leave anything out. "He indicated that suicides and suicidal 14 acts were reported infrequently in the extensive controlled 15 clinical trials on Prozac and that the emergence of suicidal 16 thinking occurred less often than in patients treated with 17 Prozac than with comparable drugs." Did you tell the board, 18 Doctor Thompson, that German studies indicated that there were 19 16 suicides and suicide attempts on Prozac and none on 20 comparitors? 21 A. That's not true. There was one on placebo and, 22 as you know, if you get that letter out which you've 23 introduced into evidence, if you look at the incidence, the 24 incidence of suicide in that report from Germany is less on 25 Prozac in terms of the number of patients, and the patients 82 1 treated with Prozac were treated much longer. So although 2 there were more reports from Prozac, obviously we treated a 3 lot more people with Prozac than with comparitors, and the 4 incidence rate was higher on placebo than on Prozac. 5 Q. Did you tell that to the board? 6 A. Yes, sir. I showed those data, along with all 7 the other data we had. 8 Q. You told the board of directors on 9 September 17th, 1990, that the BGA had brought this issue up 10 back in 1984 and '85? 11 A. I'm not sure I said that. That one I'm not sure 12 of. 13 Q. The minutes don't reflect that, do they, sir? 14 A. Well, I talked for a long time. The minutes I 15 think accurately reflect the flavor of what I said, but I 16 don't think I had a slide that said specifically, "By the way, 17 the BGA has raised this question." But I did show all -- all 18 of the data that he we had up till the day before. 19 Q. And then you concluded by saying, "Doctor 20 Thompson concluded by saying suicide, suicidal acts and 21 suicidal thoughts, therefore, more probably reflect the 22 patient's underlying disorder and not a causal relationship to 23 Prozac." Correct? 24 A. Yes, sir. 25 Q. Did you tell the board of directors what Doctor 83 1 Heiligenstein, the Lilly psychiatrist, has said: "We feel 2 caution should be exercised in the statement that suicidality 3 and hostile acts in patients reflect the patient's disorder 4 and not a causal relationship to Prozac"? 5 A. I don't remember if I attributed it to Doctor 6 Heiligenstein, but I showed them the data themselves, and I 7 showed them and talked about the controversy in how to 8 interpret the data, because only one member of the board of 9 directors is a physician, and only three are really primarily 10 scientists, and so I went in great detail over the data, all 11 of the data. 12 Q. Did you tell the board of directors that Doctor 13 Heiligenstein had told you that he felt that caution should be 14 exercised in attributing this conduct to the underlying 15 disease versus Prozac? 16 A. I do not remember using Doctor Heiligenstein's 17 name specifically. I recall -- 18 Q. Do you recall telling him whether you used -- 19 MR. STOPHER: He hasn't finished, Your Honor. 20 JUDGE POTTER: Let him finish his answer. Mr. 21 Stopher, I think Mr. Freeman is handling this part. 22 MR. STOPHER: I apologize. 23 A. As I said before, sir, I went into great detail 24 over the controversies within Lilly and with our experts and 25 how to interpret the data, and I showed the board the data and 84 1 explained the controversies. 2 Q. Was there a controversy within Lilly at this 3 time about whether or not Prozac could involve suicidality and 4 violent aggressive behavior? 5 A. Absolutely. In 1990, when we had very little 6 reports of suicidality and virtually no reports of aggressive 7 behavior, it's very difficult to draw causal relationships; 8 you do that on a basis of a group of patients, not just a few 9 patients. And so with the amount of data we had then, there 10 were a whole variety of opinions, and we went out and 11 solicited opinions to see the whole diversity of opinions. 12 There was not 100-percent agreement. 13 Q. Well, was there anybody other than Doctor 14 Heiligenstein at that time that was expressing the 15 relationship that on some reports that caution -- by virtue of 16 some reports, caution should be exercised in attributing this 17 conduct, this suicidality or violent aggressive behavior, to 18 the underlying disease instead of Prozac? 19 A. I don't think Doctor Heiligenstein was the only 20 person. We had a large number of people looking at the data. 21 Q. All right. I need to know who else expressed 22 the opinion that Prozac -- that this suicidality and violent 23 aggressive behavior could be a result of Prozac instead of the 24 underlying disease. 25 A. That's not what it says, sir. You've got to be 85 1 careful now, because what it says is that caution should be 2 exercised in a statement, which is the verbatim I had written 3 for Mr. Wood that suicidality and so forth are related to the 4 underlying disease. It doesn't say whether it is or not; it 5 says as a scientist caution should be exercised in making that 6 assertion, because we didn't have enough data to be 7 100-percent sure in 1990. 8 Q. My question is, who else in addition to Doctor 9 Heiligenstein at that time was feeling that caution should be 10 exercised in attributing this condition to the disease as 11 opposed to the drug? 12 A. As of that date I really don't know who else, 13 but I don't think he was the only person who would have said 14 that out of the dozens of people who were looking at the data. 15 Q. Well, let's look back at Exhibit 87. I see here 16 that Doctor Heiligenstein in the first paragraph under the 17 September 13th, 1990, re: proposed presentation to the board, 18 it says, "Charles, David and I have reviewed your presentation 19 and offer the following thoughts and comments." Correct? 20 A. Yes, sir. 21 Q. And then we have the language about Verbatim 4, 22 and it says, "We feel that caution should be exercised." 23 A. I pointed thought out to you before. We 24 suggests it's more than -- again, I said I don't know the 25 specific names of -- I don't think John was unique in feeling 86 1 that caution should be exercised. 2 Q. Okay. He mentioned Charles. That's Charles 3 Beasley, Jr., M.D., is it not? 4 A. Yes, sir. 5 Q. Psychiatrist, Charles M. Beasley, Jr., M.D.; 6 correct? 7 A. And author of the, as you call it, famous meta 8 analysis. 9 Q. Doctor John H. Heiligenstein we've identified. 10 David is David Wheadon, is he not? 11 A. Yes, sir. 12 Q. And David Wheadon is also a psychiatrist with 13 Lilly? 14 A. Yes, sir. 15 Q. Well-educated, bright individual? 16 A. Super psychiatrist. 17 Q. And Charles, David and Doctor Heiligenstein then 18 feel that caution should be exercised attributing these acts 19 to just simply this disease; correct? 20 A. Well, you and I are equally able to interpret 21 "we." 22 Q. Well, did you advise anybody else involved in 23 this -- I think you said controversy in September of 1990, 24 concerning -- within Lilly concerning whether or not Prozac 25 could be causing this conduct? 87 1 A. Sir, almost every day we were having meetings of 2 experts within Lilly, experts on clinical pharmacology, 3 experts on drug causality, experts on drug epidemiology. We 4 were calling in experts from all over the world. This was a 5 topic that was of intense debate almost on a daily basis. 6 Q. Did you know that Doctor Greist was one of those 7 experts that had been called in? 8 MR. FREEMAN: He's not finished his answer, 9 Judge. He keeps interrupting. 10 A. So that day by day, more and more data were 11 developed from our own data base, from publications, from 12 outside sources, and so the debate continued as we accumulated 13 more and more data, including adverse events that came in day 14 by day. And so the data constantly changed and we were 15 constantly analyzing it and constantly seeking opinions. 16 Q. Were you still massaging the data at that time? 17 A. Not only me, but all of our good statisticians. 18 Q. And was Doctor Greist one of the experts that 19 was called in? 20 A. I don't recall that specifically, but I have 21 great respect for Doctor Greist and I hope he was one of the 22 experts we consulted. 23 Q. Let's talk about the postmarketing data for a 24 while. 25 Excuse me, Your Honor. I'm hurrying. 88 1 JUDGE POTTER: No. Take your time, Mr. Smith. 2 Q. Doctor Thompson, can you identify Plaintiffs' 3 Exhibit 92? 4 A. Yes, sir. This is a Lilly E-mail message which 5 I sent to Doctor Perelman and carbon copied to a bunch of 6 other people, and I think part of it is cut off because I 7 think my message is the one after the little dots on the first 8 page at the top where it begins July 18th at 6:48 in the 9 morning. I'm not sure exactly what is above that, because it 10 doesn't show who forwarded it to somebody else. See what I 11 mean? My message began with the July 18, 1990 at 6:48 in the 12 the morning to Doctor Perelman, Zerbe, et cetera, and it 13 continues through my signature on the computer, Thompson, 14 Leigh RVAX, and then what this line under it means is that 15 somebody has now forwarded my message to Doctors Beasley, 16 Chappell, et cetera. 17 Q. But does this have the entire text of your 18 message, sir? 19 A. Yes, sir. 20 MR. SMITH: We'd offer Plaintiffs' Exhibit 92. 21 MR. FREEMAN: No objection, Your Honor. 22 JUDGE POTTER: Be admitted. 23 SHERIFF CECIL: (Hands document to jurors). 24 Q. Exhibit 92 is dated July 18th, 1990, is it not, 25 Doctor Thompson? 89 1 A. Yes, sir. 2 Q. And the time by that is 6:48; correct? 3 A. Yes, sir. That's the time at Lilly. 4 Q. And it's A.M.; is that right? 5 A. Yes, sir. 6 Q. You authored this two-page document, did you 7 not? 8 A. Yes, sir. 9 Q. And it's sent to Doctor Mel Perelman; correct? 10 A. Yes, sir. He was my boss at that time. 11 Q. He was at that time president of Lilly Research 12 Labs, was he not? 13 A. Yes, sir. 14 Q. Robert L. Zerbe was at that time a medical 15 doctor who was head of the Division of Epidemiology and 16 Neuropharmacological Drug Products at Eli Lilly and Company? 17 A. I think Bob was a vice-president at that time, 18 and I think I had given him responsibility for all of the 19 U. S. medical operation. And earlier in his career he had 20 been head of the neuropsychiatric drugs part of Lilly. 21 Q. Max Talbott was your director of regulatory 22 affairs? 23 A. Yes, sir. 24 Q. Dan Masica was who? 25 A. I think he was the current director of the 90 1 neuropsychiatric drugs group and I think he reported to Doctor 2 Zerbe. 3 Q. Merle Amundson? 4 A. Merle was an executive director at that time. 5 He's since retired, and he was one of the scientists in our 6 toxicology laboratories. 7 Q. Philip Reid? 8 A. Philip Reid was a vice-president in medical. 9 He's a cardiologist internist. At that time I think his 10 responsibility was largely the Lilly clinic, the 62-bed 11 research center where we give drugs to people. 12 Q. And Rebecca Goss? 13 A. Becky Goss at that time was one of Lilly's 14 senior attorneys, and I think she was responsible for all of 15 Lilly Research Laboratories at that time. 16 Q. So would it be accurate to say that you were an 17 executive with the corporation at the time? 18 A. Yes, sir. 19 Q. Doctor Perelman was certainly an executive with 20 the corporation at that time? 21 A. Yes, sir. 22 Q. Doctor Zerbe was an executive with the 23 corporation at that time? 24 A. Yes, sir. 25 Q. Doctor Talbott was an executive with the 91 1 corporation at that time? 2 A. He was a director. It depends how you want to 3 define executive. We were all Lilly employees at relatively 4 senior positions. 5 Q. All right. And the E-mail says, "Paul Leber 6 called yesterday. I contacted him at 6:15 A.M. this morning 7 and half-hour conversation. Very, very pleasant with Paul and 8 Tom Laughren." Now, at this time Paul Leber was the head of 9 the FDA division that approved Prozac; is that right? 10 A. Yes, sir. 11 Q. And who was Tom Laughren? 12 A. Tom Laughren is a psychiatrist, who is a deputy. 13 I think his official title is group leader, so that under 14 Doctor Leber I think there are two group leaders, and Doctor 15 Laughren is the one that handles psychiatric products like 16 Prozac. 17 Q. You contacted Paul Leber at 6:15 A.M. in the 18 morning? 19 A. That was Indianapolis time; that's 7:15 A.M. in 20 Washington. That's about the time we usually had been 21 talking. 22 Q. You and Doctor Leber, as I understand it, had 23 frequent early morning phone conversations? 24 A. Well, I'm not sure they were frequent 25 conversations, but they were almost all early in the morning. 92 1 Q. Well, you've identified four at least already 2 throughout your testimony, haven't we? 3 A. Yes, sir. 4 Q. And was it 6:15 -- were you in your office at 5 6:15 A.M. at that point? 6 A. Oh, goodness, yes; I had been there for some 7 time, probably. 8 Q. You say the call was about suicide? 9 A. Yes, sir. 10 Q. They -- I assume that was Doctor Leber and 11 Doctor Laughren said, "This morning's Wall Street Journal 12 article in their mind was trivial and the reporter had called 13 them." Correct? 14 A. Yes, sir. 15 Q. I assume the article in The Wall Street Journal 16 was in some way some report on some relationship between 17 Prozac and suicidality? 18 A. I assume so. 19 Q. Well, this is now six months after Doctor 20 Teischer had published his article? 21 A. I honestly don't remember what was in The Wall 22 Street Journal. 23 Q. Well, July was six months after Doctor Teischer 24 had published his article in the American Journal of 25 Psychiatry? 93 1 A. Yes, sir. 2 Q. And this is six years after this issue has been 3 raised by the BGA? 4 A. Yes, sir. 5 Q. Did they feel some data -- they say, "However, 6 this issue is building and will not go away. They feel some 7 data are required and wanted a study or studies of the issue. 8 Paul suggested several designs." Correct? 9 A. Yes, sir. 10 Q. Number One was a case-control retrospective 11 study; correct? 12 A. Yes, sir. 13 Q. Was that study done? 14 A. We worked real hard to put it in place and never 15 found a way to do it, so it was not done. 16 Q. So is the answer to my question, no, that study 17 wasn't done? 18 A. The answer is the study has not been done. 19 Q. Is that study planned at this time? 20 A. I don't think so. 21 Q. The next thing Doctor Leber, with the FDA, was 22 suggesting was a cohort study. "Paul feels the power is low, 23 but if the incidence is 3.5, even a small study should be able 24 to establish relative rates between fluoxetine and other 25 treatments. Also it should set an upper limit on the 94 1 incidence of the emergence of suicidal ideation." 2 A. Yes, sir. 3 Q. Was a cohort study done, Doctor Thompson? 4 A. Not the way it's described here. 5 Q. Is a cohort study planned? 6 A. Well, cohort studies that address this issue 7 have in fact been done. They were going on at this time and 8 they've been done since then, as we've talked about many 9 times. 10 Q. Has the cohort study as suggested by Doctor 11 Leber and Doctor Laughren with the FDA been done? 12 A. Well, yes. I said that cohort studies that 13 address this issue were ongoing at that time and have 14 subsequently been started and finished and reported. 15 Q. Was the incidence 3.5 percent in your cohort 16 studies? 17 A. No. And no study -- no study ever showed an 18 incidence of 3.5 percent. 19 Q. All right. Three is: "Best would be a larger 20 blind prospective study designed with the help of Teischer to 21 detect his phenomenom." Correct? 22 A. Yes, sir. 23 Q. Was a large blind prospective study ever done? 24 A. Yes, sir. A large blind prospective study was 25 done. We never found a way to detect his phenomenon. 95 1 Q. All right. When was the large blind prospective 2 study done? 3 A. Oh, there have been a number of them done with 4 Prozac after this memo in 1990, dozens. 5 Q. Identify those large blind prospective studies 6 looking at the issue of emergence of suicidality with Prozac. 7 A. We have done dozens of large -- 8 Q. Identify them, Doctor Thompson. 9 A. I don't have the code numbers of those studies 10 in my head, sir. They're easily producible. 11 Q. They haven't been produced? 12 A. Sir, you asked me have we done larger blind 13 prospective studies that address suicidality. The answer is 14 we've done dozens since this time, and we could easily go and 15 find their code numbers and their descriptions and their 16 results. 17 Q. We will. 18 The next page, on Page 2, second paragraph you 19 say, "He said that Temple had asked that we not effect label 20 changes on the suicide issue without clearing them with the 21 FDA first. I think Paul would like this in general but 22 emphasized Bob's interest specifically on the suicide issue. 23 There wasn't anything else that hinted to more need for label 24 change. I promised we would on suicide not use the provision 25 for effecting the change." Correct? 96 1 A. Yes, sir. 2 Q. Now, is it true that at that time, Doctor 3 Thompson, that Lilly could have effected a label change 4 without FDA approval? 5 A. We had made 20 or more changes in the Prozac 6 label up to that time. We could for sure change the label in 7 certain respects, only in certain respects without prior 8 authorization of the FDA. 9 Q. In this issue of suicide and whether or not it 10 caused violent-aggressive behavior, you could change the label 11 without prior FDA approval, couldn't you, sir? 12 A. If we were to put a new warning in, yes, that's 13 something that we could implement without their prior 14 authorization. 15 Q. You could have done that in 1990? 16 A. Yes, sir. 17 Q. You could have done that before September 14th, 18 1989? 19 A. Yes, sir. 20 Q. You could have done that at the time that the 21 product was put on the market in this country in December 22 1987, couldn't you? 23 A. Yes, sir. And we could do it today. 24 Q. But you haven't and you won't, will you? 25 A. Well, we haven't. I can't address the future. 97 1 Well, wait a second. Wait a second. Let me go back and 2 qualify that because we have made changes in the label that 3 relate to suicidality, so we need to be very specific about 4 what we mean. 5 Q. And how have you changed the label as it relates 6 to suicidality? 7 A. I think we have added the statement that -- you 8 would have to go look at the exact language but, roughly, that 9 suicidality and I think it says aggressive behavior or 10 aggressive acts have been seen in patients who have been 11 intended to give Prozac. 12 Q. All right. That particular portion of the label 13 says there's no causal relationship between Prozac and those 14 behaviors, doesn't it? 15 A. That's exactly correct. But let's look at the 16 exact wording. 17 Q. Got it. 18 A. Hey. 19 Q. The part discussing suicide specifically says, 20 "The possibility of a suicide attempt is inherent in 21 depression and may persist until significant remission occurs. 22 Close supervision of high-risk patients should accompany 23 initial drug therapy. Prescriptions for Prozac should be 24 written for the smallest quantity of capsules consistent with 25 good patient management in order to reduce the risk of 98 1 overdose." Correct? 2 A. Yes, sir. 3 Q. Now, that's not a warning that Prozac can cause 4 suicide or violent-aggressive behavior, is it, Doctor? 5 A. I hope not. Heavens, no. 6 Q. Because you don't believe that Prozac does cause 7 suicide or violent-aggressive behavior, do you? 8 A. And the FDA doesn't believe it and I don't think 9 anybody at Lilly believes it. 10 Q. Except maybe Doctor Heiligenstein, maybe Doctor 11 Beasley, maybe Doctor Wheadon and maybe, certainly as we've 12 heard, Doctor Greist? 13 A. As of 1990, all those things are possible, but 14 why don't we ask them what they believe. 15 Q. Here under Adverse Reactions, is that where it's 16 going to be about suicide and violent behavior? 17 A. Yes, sir. I think we added it down there. It 18 should be under Nervous System. 19 MR. FREEMAN: We're losing some of the sound. 20 JUDGE POTTER: Keep your voices up. 21 MR. SMITH: Here it is. Down here it begins 22 Adverse Reactions right up here, doesn't it? 23 A. Yes, sir. Adverse Reactions. 24 Q. And then down here under Post-Induction Reports. 25 A. Post-Introduction, after the drug is introduced 99 1 into the market. 2 Q. It says, "Voluntary reports of adverse events 3 temporarily associated with Prozac that had been received 4 since market induction..." -- 5 A. Introduction. 6 Q. Introduction. I'm trying to read it; it's real 7 small -- "...that are not listed above and that may have no 8 causal relationship with the drug include the following." 9 A. May have no causal relationship; yes, sir. 10 Q. And the very last one is violent behavior; 11 right? 12 A. Yes, sir. 13 Q. And suicidal ideation is in the next-to-the-last 14 sentence, isn't it? 15 A. They're listed alphabetically, sir. That's why 16 S is towards the end and V is at the end. 17 MR. SMITH: Since we've referred to this, any 18 objections? 19 MR. FREEMAN: No objection. 20 MR. SMITH: Well, this is a recent. We'll get 21 an earlier one. 22 So, there is no warning that Prozac can cause 23 violent-aggressive behavior in the Prozac package insert, is 24 there? 25 A. There's a specific part that's called Warnings 100 1 and it's not in that part. You're absolutely right. 2 Q. Turn back with me to Page 2 of Exhibit 92. 3 A. Yes, sir. 4 Q. The next-to-the-last paragraph says, "Paul is 5 taking a position in talking with outside folks today that 6 Lilly and FDA and working together." It should read "are," 7 should it not? 8 A. (Nods head affirmatively). 9 Q. "Lilly and FDA are working together on the 10 suicide issue and following closely the postmarketing events, 11 but that there are no denominators, and the best that can be 12 done is to put a 'cap' on the number of events." Correct? 13 A. Yes, sir. 14 Q. So Doctor Leber -- is this a direct quote from 15 Doctor Leber? 16 A. The "caps" in quotes? 17 Q. Yeah. 18 A. I don't know whether that's his word or mine. 19 It's one of my words, but I can't recall whether he used that 20 word. 21 Q. Okay. The word you used was that Doctor Leber 22 suggested that the best thing that you -- that is, Lilly -- 23 could do is to put a cap on the number of postmarketing 24 events; correct? 25 A. Yes, sir. It's referring back to what he said 101 1 at the beginning of that memo which -- and he probably did use 2 the word "cap." I mean, it has a specific meaning. 3 Q. All right. Okay. Can you identify Exhibit 151? 4 A. It looks like a tabulation of our adverse 5 events. It looks like this is restricted to postmarketing 6 spontaneously reported adverse events through the end of 1992 7 for Prozac -- although, interestingly that word is never used, 8 but it says, "Patients worldwide exposed, 8,789,000," so I 9 assume this is just Prozac. 10 MR. SMITH: We'd offer Plaintiffs' Exhibit 151, 11 Your Honor. 12 MR. FREEMAN: Your Honor, we have a previous 13 ruling on that subject. These are summaries. 14 JUDGE POTTER: Okay. Be admitted. 15 SHERIFF CECIL: (Hands document to jurors). 16 Q. Let's look at Table 1 of Exhibit 151. You say 17 this is the postmarketing events in connection with Prozac; is 18 that right? 19 A. That's what it says. 20 Q. It says, "Estimated worldwide population 21 exposed, 8,789,000." Correct? 22 A. Yes, sir. 23 Q. Where was that number obtained? 24 A. That number is obtained by two means; the first 25 means is knowing how many pills we've actually sold on a 102 1 worldwide basis, and the second means is by auditing 2 prescriptions to find out what the number of pills is that the 3 average patient takes. So if the average patient takes 100 4 pills and we've sold 878,000,000, you divide one by the other 5 and that's the estimated number of patients. 6 Q. All right. Now, when you talk -- let's make 7 sure we all understand this. When you use this 8-million 8 figure as of December 31st, 1992, that's not the amount of 9 people that are currently taking that medication at that date, 10 is it? 11 A. No, sir. That would be all the patients who 12 outside of clinical trials are likely to have taken Prozac for 13 any indication at any dose for any period. 14 Q. And it's whether they took one pill or one 15 thousand pills? 16 A. That's correct, sir. 17 Q. Okay. So the number of people actually taking 18 Prozac at any one time could probably have never been 19 8,789,000 people, could it? 20 A. Oh, certainly not. 21 Q. All right. Any estimate? Would it have been 22 4 million people at this time that had taken Prozac? 23 A. I'm sorry. I really don't know that number. I 24 think that's a little high, though. I wouldn't estimate it to 25 be that high myself. 103 1 Q. Could we put 3 million people that had taken 2 Prozac by this time? 3 A. Oh, by this time? By this time I think the 8.8 4 million is correct. But at this specific date on December 31, 5 1992, -- I thought that's what you were asking me -- I don't 6 know what the number would be. 7 Q. Yeah. But of those 8 million people they might 8 have taken as little as 1 or as many as 100? 9 A. Yes, sir. 10 Q. So there's got to be less than 8 million people, 11 doesn't it? 12 A. I said that; yes, sir. 13 Q. And you say maybe on December 31st, 1992, it 14 would be less than 3 million people? 15 A. I said I really don't know, but I'll buy into 16 that number, something like that. I don't know, 2 million, 17 3 million, something. 18 Q. Now, Table 1 is the body system as a whole, is 19 it not? 20 A. Yes, sir. 21 Q. And then Table 8 is specifically the nervous 22 system, is it not? 23 A. Yes, sir. So we're missing a whole bunch of 24 tables. 25 Q. Well, but these are going to be the tables that 104 1 are applicable, are they not, to the issue of suicidality and 2 violent-aggressive behavior? 3 A. I hope so. I'm not sure where all the other 4 terms are, I mean, which other tables have terms that might be 5 related. 6 Q. As of December 31st, 1992, there had been 120 7 reports of death. On Page 1, it shows death, 120 reports of 8 death? 9 A. Yes, sir. The event, death, occurred on 120 10 reports. 11 Q. There were 1,514 reports of headache; is that 12 right? 13 A. Yes, sir. That event term was used on 1,514 14 reports. 15 Q. There were 240 reports of intentional injury, 16 were there not? 17 A. Yes, sir. 18 Q. There were 151 reports of intentional overdose, 19 were there not? 20 A. Yes, sir. 21 Q. There were 1,284 reports of overdose, weren't 22 there? 23 A. Yes, sir. 24 Q. There were 9 reports of sudden death, were there 25 not? 105 1 A. Yes, sir. 2 Q. There were 1,260 reports of suicide attempts, 3 weren't there? 4 A. Yes, sir. 5 Q. I don't see a listing of suicide -- suicidal 6 ideation on this. 7 A. I think that was coded under the term 8 depression -- I think that's correct. Why don't we look back. 9 Oh, if you look back at Table 8 under the Ds. 10 Q. Is that on Page 432? 11 A. Yes, sir. I think the depression 2,168 includes 12 reports which would be suicidal ideation. 13 Q. All right. So we've got 2,168 reports of 14 depression, which would include reports of suicidal ideation; 15 correct? 16 A. I think that's where those would be classified; 17 yes, sir. 18 Q. All right. Since we're on that page, if you 19 turn down to the middle of the page you'll see hostility, 20 won't you? 21 A. Yes, sir. 22 Q. That's on Page 432, PZ 2334; 432, correct? 23 A. Yes, sir. 24 Q. Hostility, 757 reports of hostility, were there 25 not? 106 1 A. Yes, sir. 2 Q. Twenty-four reports of hysteria, weren't there? 3 A. Yes, sir. 4 Q. Twenty-two reports of manic depressive reaction? 5 A. Yes, sir. 6 Q. Let's go back to the first of this nervous 7 system. 8 A. Go on to the next page because it's only fair to 9 include manic reaction, as well. 10 Q. All right. Manic reaction, 645 instances of 11 that, reports of that? 12 A. Yes, sir. 13 Q. Let's go back to Page 1 of Table 8, which is 14 Page 431. There are 1,571 reports of agitation, are there 15 not? 16 A. I'm sorry. On Page 1, which would be 416? 17 Q. No. 18 A. I'm sorry. 19 Q. It's Page 1 of Table 8, I believe. 20 A. Oh, I'm sorry. I apologize. 21 Q. It's Page 431. 22 A. Agitation, 1,571; yes, sir. 23 Q. Akathisia is relevant here, isn't it? 285 24 reports of akathisia; correct? 25 A. Doctor Teischer thinks it's relevant and there 107 1 are 285 reports thereof. 2 Q. And when you were reviewing the postmarketing 3 events in determining whether or not there was any 4 relationship of Prozac to suicidality and violent-aggressive 5 behavior, you looked at reports of akathisia; did you not? 6 A. Absolutely. 7 Q. All right. Antisocial reaction, 6? 8 A. Yes, sir. 9 Q. Anxiety, 1,350 reports of anxiety? 10 A. Yes, sir. 11 Q. So we've got 1,571 reports of agitation and 12 1,350 reports of anxiety; right? 13 A. But, as you know, both reports could be one 14 patient who has both events. These are events, not patients, 15 but you're absolutely correct about the numbers. 16 Q. In those instances, the doctor would be 17 reporting both anxiety and agitation in connection with a 18 patient if there was a double report, wouldn't he? 19 A. Yes, sir. 20 Q. Looks like there was 761 reports of confusion, 21 doesn't it? 22 A. Yes, sir. That's correct. 23 Q. Ninety-five reports of delusions? 24 A. Yes, sir. 25 Q. Forty-nine reports of CNS stimulation? 108 1 A. Yes, sir. 2 Q. If we turn to Page 433, we'll get some more 3 events that are significant here. You mentioned manic 4 reaction, 645 instances of manic reaction; correct? 5 A. Yes, sir. I think all these events are 6 significant. 7 Q. Significant to this question is what I'm talking 8 about. 9 A. You mean suicidality and violent behavior? 10 Q. Yes, sir. 11 A. Yes, sir. 12 Q. If I mention one that's not something that has 13 been investigated on this issue, let me know, okay? 14 A. Yes, sir. 15 Q. Nervousness, 1,304? 16 A. Yes, sir. Neurosis, 98. 17 Q. Neurosis, 98. Personality disorder, 478? 18 A. Yes. But I'd pick up paranoid reaction, 145. 19 But the personality disorder's 478; yes, sir. 20 Q. Psychosis, 220? 21 A. Yes, sir. 22 Q. Psychotic depression, 5? 23 A. Yes, sir. 24 Q. Schizophrenic reaction, 9? 25 A. Yes, sir. 109 1 Q. Sleep disorder, 162? 2 A. Yes, sir. But I'd also put in the one screaming 3 syndrome, whatever that is. And I think you've got to put 4 somnolence in, too. I mean, that was part of our analysis, I 5 mean, 1145 people with somnolence. 6 Q. All right. I didn't see insomnia. 7 A. Let's go back and look. 8 Q. Oh, here it is. Insomnia, 1,363; that's on Page 9 432. 10 A. That's plus the sleep disorder, 162, although, 11 again, it could be the same patient has both events, but there 12 are other sleep disorders besides insomnia. 13 Q. I see 757 reports of hostility here on 14 Page 432. 15 A. Yes, sir. 16 Q. Do you see that? I don't see any reports of 17 intentional injury, though, do you? 18 A. I don't think that's an FDA term. Again, it 19 might be on one of the tables we're not seeing, but I don't 20 know if intentional injury is one of the COSTART terms the FDA 21 uses or not. 22 Q. Can you identify Exhibit 120, Doctor Thompson? 23 A. This seems to be -- the front of it is a memo 24 from Doctor Al Webber to the NDA files, which is our 25 regulatory file at Lilly, talking about a meeting with the 110 1 psychopharmacological drug advisory committee, and then there 2 are a bunch of attachments to it. So I assume that these are 3 all things that were used -- that were at least filed -- they 4 appear to have been filed in our NDA files relevant to the 5 September 20th, 1991 meeting of the psychopharmacological 6 drugs advisory committee of the FDA. 7 Q. And this has mention of hostility and 8 intentional injury, does it not, this data? 9 A. Yes, sir. It has on Page 1902, the line it has 10 hostility, then under it it's got intentional injury and it's 11 got in parentheses July 1989. I think that means -- you want 12 me to explain it? 13 Q. (Nods head affirmatively). 14 A. I'm going to have to tell you I think what that 15 means is that that term was either added to or taken out of 16 the Lilly version of COSTART, COSTART being the FDA list of 17 terms. And my guess is that happened on July 1989, but I 18 don't know whether it went in or it went out. 19 MR. SMITH: We'd offer Plaintiffs' Exhibit 120. 20 MR. FREEMAN: No objection. 21 JUDGE POTTER: Be admitted. 22 SHERIFF CECIL: (Hands document to jurors). 23 A. Mr. Smith, now that I've had a chance to read 24 the cover memo, it appears that some of these slides were 25 prepared from Doctor Potter. I can't tell where Attachment 3 111 1 is. There are several attachments here and I can't tell who 2 made the slides. See, "Finally a copy of the slides shown by 3 Lilly speakers is attached." I honestly don't know which of 4 these came from Lilly and which came from the FDA and which 5 came from whoever Doctor Potter is. 6 Q. But they would have come from either Doctor 7 Potter, the FDA or Lilly? 8 A. Well, that's all the people that are named. 9 Q. Well, who is Doctor Potter? 10 A. I don't have any idea. 11 Q. All right. Turn with me to the first page of 12 the -- Page 1900. 13 A. Yes, sir. 14 Q. It lists drugs, does it not? 15 A. Yes, sir. 16 Q. It lists fluoxetine, Trazodone, amitriptyline, 17 Desipramine and Maprotiline, correct? 18 A. Yes, sir. 19 Q. That may be the first time I said Maprotiline 20 correctly. Trazodone is a tricyclic antidepressant? 21 A. Some scientists say it's a derivative of 22 tricyclics, but why don't we say that all of these are 23 antidepressants and, except for fluoxetine, all of them are 24 either tricyclics or slight variants on tricyclics. 25 Q. Would it be appropriate to say, Doctor Thompson, 112 1 that fluoxetine is the only specific serotonin reuptake 2 inhibitor of this listing of drugs? 3 A. Yes, sir. That's correct. 4 Q. And if we turn to Page 1901, we see that 5 prescriptions for selected antidepressants in millions, do we 6 not? 7 A. Yes, sir. 8 Q. And maybe the original slides were in color. 9 It's hard to distinguish fluoxetine versus amitriptyline, is 10 it not? 11 A. Well, but I think fluoxetine is probably the top 12 bar, particularly because its bar begins in 1988 when we 13 marketed fluoxetine in the United States, so that's probably 14 the top segment. 15 Q. Okay. That was going to be my next question. 16 Would it be reasonable to assume the top segment is Prozac and 17 the bottom segment is amitriptyline? 18 A. Yes, sir. 19 Q. Now, if you look at this graph and it's up to 20 1990, it includes 1982, 1983, 1984, 1985, 1986 and 1987? 21 A. Yes, sir. 22 Q. And Prozac basically wasn't on the market during 23 those years? 24 A. Was not on the market. 25 Q. But the other antidepressants were? 113 1 A. Yes, sir. 2 Q. And the data up to 1987 is reflective of the 3 amount of prescriptions in millions of these other 4 antidepressants up to that time; correct? 5 A. Yes, sir. 6 Q. Then if you look at 1988, 1989 and 1990, if you 7 look at the top you'll see that Prozac has entered the market. 8 A. Yes, sir. 9 Q. But these -- that graph took a period of time 10 into account before Prozac came on the market, did it not? 11 A. Yes, sir. 12 Q. And then if you look at the next page, 1902, it 13 says COSTART terms: suicide attempt, psychotic depression, 14 overdose, hostility and intentional injury, July 1989? 15 A. Yeah. That dates the intentional injury. The 16 suicide attempt has the notation January '89, and those were 17 changes either the FDA or Lilly or maybe both of us made in 18 the use of those terms, I presume, on those dates. 19 Q. Well, if this was July of 1989, do you know why 20 this table that we have marked as Plaintiffs' Exhibit 151 21 wouldn't have intentional injury on it? 22 A. Well, I think -- I mean, the whole description, 23 as you know, requires an understanding of COSTART and how the 24 FDA codes adverse events. I think that term was replaced by 25 putting those events under another term as of the date of 114 1 July 1989, but that's just the best of my memory. 2 Q. What other term would they go under? 3 A. I don't remember the rules at that time, sir. 4 The important thing is that the FDA classifies adverse events 5 into roughly 1400 different buckets. And so hostility is the 6 title of one of those buckets. And so if you were report to 7 the FDA that you took Ceclor and you got real mad, they would 8 take those words and they'd say that tracks to our bucket 9 called hostility, and they would therefore classify that event 10 term under hostility. They could use other terms as well for 11 describing the same thing. 12 Q. What was the bucket for intentional injury? 13 A. Well, I think that got taken out, but I'm not 14 100-percent sure of it. I do think it was changed and around 15 that date. It was either put in or taken out. 16 Q. All right. Turn to Page 1903. That shows the 17 spontaneous domestic reports received January 1982 until July 18 1991, for suicide attempts, overdose and psychotic depression; 19 correct? 20 A. Yes, sir. 21 Q. These are all relevant to the issue of whether 22 or not there's any relationship between Prozac and 23 suicidality; correct? 24 A. Yes, sir. I'm surprised that the FDA limited it 25 to domestic, which means U. S. reports, but I think that's 115 1 because their chart of the prescriptions is probably also 2 U. S. data. 3 Q. Trying to compare apples with apples? 4 A. Yes, sir. 5 Q. It indicates here that from January 1982 until 6 July 1991, there had been 519 reports of suicide attempts, 7 468 reports of overdose, and 321 reports of psychotic 8 depression, does it not? 9 A. Yes, sir. And I'm not sure how they did their 10 compilation because there are actually two overdose terms 11 which are very confusing. There's an overdose term and an 12 intentional overdose term. If I were doing this, I would put 13 both of those together under overdose, but I honestly don't 14 know how they did this. 15 Q. Now, those reports would have been reports that 16 were received from 1987 to 1991, is that right, for Prozac? 17 A. I think 1982. 18 Q. Beg your pardon? 19 A. I think 1982 is the date. 20 Q. It goes to '82, but Prozac didn't go on the 21 market until actually 1988, did it? 22 A. Oh, I'm sorry. It would be 1988 inclusive 23 through July 1991. 24 Q. So when you compare these figures, these other 25 antidepressants have a big jump on Prozac as far as reporting 116 1 of adverse events, don't they, because they've been on the 2 market for six years before Prozac came on? 3 A. Actually, it's the other way around, but they 4 had been on the market for a long time, which is why there 5 were more adverse-event reports with fluoxetine. 6 Q. That's probably subject to some debate, Doctor 7 Thompson. But the fact is is that Prozac didn't come on the 8 market really until 1988; correct? 9 A. That's a fact; yes, sir. 10 Q. And these other antidepressants that are listed 11 here had been on the market for some time? 12 A. Actually, I think most of them had been on long 13 before 1982. 14 Q. The compilations here come from '82 up to 15 July '91? 16 A. Yes, sir. 17 Q. All right. You'll agree with me that there is 18 much more reports of suicide attempt, overdose and psychotic 19 depression on Prozac than these other antidepressants? 20 A. Yes, sir. And the other thing that's important 21 to point out is that, again, if I'm correct in the change in 22 the use of the term "suicide attempt," at least some of those 23 468 overdoses may actually have been the same kind of report, 24 which after the change would have been put into the suicide 25 attempt bucket. So I don't know whether you add these two 117 1 numbers together to get the total number of patients, probably 2 something less than that. But some of the things that say 3 overdose, which could include just accidentally taking twice 4 as many pills, my guess is that many of these are in fact 5 suicide attempts listed in the overdose buckets. 6 Q. Same could be said, though, for the other 7 antidepressants, too? 8 A. Yes, sir. 9 Q. I mean, the rules are the same for all of these, 10 aren't they? 11 A. Yes, sir. 12 Q. All right. Page 1904 is the same data but 13 dealing with the violent-aggressive behavior issue and it's 14 data using the terms hostility and intentional injury, isn't 15 it? 16 A. Yes, sir. 17 Q. And, again, the other antidepressants here have 18 a six-year jump on Prozac, don't they? 19 A. In terms of the reports here. 20 Q. And if you look back on the first page, as far 21 as prescriptions, certainly if you add up all these figures on 22 Page 1901 where it gives the total number of prescriptions, 23 Prozac is not going to exceed these others, is it? 24 A. Oh, no, sir. 25 Q. Going to be less, in fact, isn't it? 118 1 A. Oh, yes, sir. Considerably. 2 Q. But there's more reports of hostility and 3 intentional injury in connection with Prozac than all the 4 others combined, isn't there? 5 A. Absolutely. 6 Q. Even though the others had been on the market 7 for six years, hadn't they? 8 A. Longer than six years. 9 Q. Well, the six years is what's been reported 10 here; right? 11 A. Yes, sir. But it is relevant that they've been 12 on the market even longer than that. 13 Q. Look with me at Page 1905. 14 A. Yes, sir. 15 Q. It lists the percentages of suicide attempts, 16 overdose and then psychotic depression, does it not? 17 A. Yes, sir. 18 Q. And this is true percentage representation, it's 19 not based on just total numbers, is it? 20 A. No. I think that the 14,198 is the number under 21 fluoxetine of either the total reports or the total events. I 22 think it means reports. And ordinarily one patient would at 23 one time have one report, even though there could be multiple 24 terms. 25 Q. All right. But let me take you, for example, 119 1 for suicide attempt for the number of -- and I assume this is 2 the same number of years, don't you? 3 A. Yes, sir. 4 Q. All right. For the number of suicide attempts 5 there was -- versus the amount of reports generated, there was 6 3.7 percent of suicide attempts; right? 7 A. Again, I would interpret that as saying of all 8 the adverse-event reports, the 1639s you talked about that the 9 FDA had on fluoxetine over this time period, 3.7 percent of 10 them had been classified by the FDA into the suicide attempt 11 bucket. But, as I said before, some of the 3.4 percent under 12 overdose in my opinion are also suicide attempts that were 13 just classified under overdose because that was the rule 14 earlier. 15 Q. Well, suicide attempt and overdose are generally 16 the same type of self-directed violent behavior, are they not, 17 Doctor Thompson? 18 A. Well, overdose includes accidental overdoses. 19 It includes some other things. 20 Q. But that normally wouldn't be reported as an 21 adverse event like overdose with a suicide attempt, would it? 22 A. Yes, sir; it would. In fact, if you read the 23 FDA regulations, they're entirely explicit about those 24 overdoses being reported to them; whereas, in Europe they 25 exclude those from adverse-event reports, but in the U. S. you 120 1 report them. 2 Q. I'm talking about the likelihood of a doctor 3 reporting an overdose where you had an accidental overdose. 4 It's much less likely that you're going to get a doctor 5 reporting, "I had some patient that accidentally took two 6 pills instead of one" versus "I had a patient that tried to 7 overdose and kill themselves on Prozac." 8 A. Mr. Smith, remember that most physicians 9 treating somebody who had taken an excess of Prozac for any 10 reason would call Lilly to get information about that event. 11 And if they talked to any of the 30,000 of us that work at 12 Lilly, that would be part of this event report and part of 13 this calculation. What I was saying is the things that are 14 overtly suicide attempts, including by gunshot or hanging or 15 nondrug-related event, used to be put in the bucket called 16 overdose. That's why I was trying to make the point, because 17 it's confusing. So a lot of them, 3.3 percent, are in fact 18 really suicide attempts. 19 Q. So we're straight on that, when you look at 20 overdose, even though it may include a few accidental 21 overdoses, the majority of those are intentional overdoses? 22 A. Yes, sir. 23 Q. Because you didn't have anyplace else to put 24 suicide attempt for a long time? 25 A. That's correct, sir. 121 1 Q. All right. Of the suicide attempts reported on 2 fluoxetine there was 3.7; right? 3 A. 3.7 percent of all the reports, in fact, were 4 put into that bucket; yes, sir. 5 Q. All right. On Trazodone it was 0.2 percent, 6 wasn't it? 7 A. Yes, sir. 8 Q. Overdose was 3.3 on fluoxetine; correct? 9 A. Yes, sir. 10 Q. And 3.4 on Trazodone; correct? 11 A. Yes, sir. 12 Q. 2.3 instances of psychotic depression; correct? 13 A. Yes, sir. 14 Q. .02 on Trazodone; correct? 15 A. 0.2. Yes, sir. 16 Q. 0.2. Turn with me to 1906. Is this not the 17 same comparison and at this time comparing outward-directed 18 violence? 19 A. Yes, sir. Although, intentional injury could 20 include -- it could include a self-inflicted wound if for some 21 reason it hadn't gone into the suicide attempt bucket. 22 Q. All right. 23 A. I mean, each one of these reports has its own 24 narrative because you get exactly the words used by the 25 reporter, and it's not always 100-percent clear which bucket 122 1 to put it in, and the FDA and Lilly often disagree. 2 Q. Anything else you want to explain, Doctor 3 Thompson, before I ask my next question? 4 A. There's a whole ton, but I'm not sure you want 5 me to. 6 Q. Here there was -- if you add hostility and 7 intentional injury as a percentage of reports on Prozac, what 8 will you get, if you add 1.6 and .08 -- 0.8? 9 A. 2.4 percent. 10 Q. All right. If you compare that with Trazodone 11 and add .4 and .1, what will you get, .5? 12 A. Point five. 13 Q. So in differing in percentages, how much 14 difference in percentages is there? 15 A. Between 2.4 and .5? 16 Q. Uh-huh. 17 A. It's a difference of 4.8 fold or 480 percent? 18 Q. So there is 400 and how many? 19 A. Four hundred eighty percent more -- you've got 20 to be careful adding those two because, again, the same 21 patient might have been classified in both buckets but most of 22 them wouldn't be. 23 Q. But that's going to be the case with both 24 antidepressants, isn't it, Doctor? 25 A No, sir. I said 480 percent more percent of 123 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 124 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 adverse-event reports with fluoxetine than Trazodone. 123 1 Q. Is that statistically significant, 2 Doctor Thompson? 3 A. It depends on how you choose the denominator and 4 the time factor. 5 Q. We're talking about comparing the two. 6 A. But, Mr. Smith, that's why we have a lot of good 7 statisticians, because if you want to ask -- let's frame your 8 question correctly because you normally in statistics don't 9 use percentages if you multiplied those by the 14,000 and the 10 2,000 what you're saying is there are a whole bunch more 11 reports on fluoxetine than Trazodone, yes, is it the fact that 12 there are more reports are those two numbers significantly 13 different, yes. Okay. 14 Q. Okay. But to really understand it you've got to 15 get a statistician to massage some data before you really 16 know? 17 A. I think you have to be very specific about how 18 you do the tests and we're just batting these around. 19 Q. These are FDA or Lilly documents, it's not 20 something I generated. You understand that, don't you? 21 A. No, sir. I think these are FDA slides. 22 MR. SMITH: All right. We're getting close to 23 lunchtime. 24 JUDGE POTTER: Let me see you-all up here. 25 124 1 (BENCH DISCUSSION) 2 JUDGE POTTER: I thought the plan was you were 3 going to finish this witness today. 4 MR. SMITH: I got to stop when I got to stop. I 5 mean, I just was going to cover one deal. 6 JUDGE POTTER: How much more have you got to 7 finish this witness today? 8 MR. SMITH: Well, frankly, I had planned on 9 stopping at 12:30 and either passing the witness or letting 10 him come back. I thought that the man had to leave and, you 11 know, I didn't know whether I would be finished with him or 12 not. I can say pass the witness because he's going to ask him 13 some questions later on, I assume, and I don't think this is 14 the last opportunity I got to talk to him. 15 JUDGE POTTER: I was under the impression that 16 you were under the impression that you had to finish today and 17 so you were planning to finish with him today. 18 MR. SMITH: And that's what I'm going to do. I 19 mean, I can continue to offer more evidence, but as far as I 20 think having essentially what I wanted to prove from this man, 21 I've done it. 22 JUDGE POTTER: If he finishes today, what are 23 your plans, Mr. Freeman? 24 MR. FREEMAN: To call him back for the two hours 25 that you've allotted him on Monday. 125 1 JUDGE POTTER: If he comes back on Monday, how 2 much time do you want with him on Monday, Mr. Smith? Because 3 you can argue with this guy for the rest of the trial. 4 MR. SMITH: Yeah. You know, I would think that 5 we wouldn't need any longer than the rest of Monday. 6 JUDGE POTTER: All day Monday? 7 MR. SMITH: I don't think I'll need more time 8 than Joe. I may not need as much time as Joe. 9 JUDGE POTTER: You can have him for an hour and 10 a half on Monday and you finish up and we'll go to lunch, and 11 I know you object to your time limit. 12 MR. FREEMAN: What are we saying exactly, now, 13 Judge? 14 JUDGE POTTER: Mr. Smith will have an hour and a 15 half Monday morning and then you can have him. We'll take our 16 noon break and then we'll go to lunch and we'll go onto 17 something else in the afternoon. 18 MR. FREEMAN: That's fine. 19 MR. SMITH: Is that going to be enough time for 20 what you need to get out of your witness? I don't want Mr. 21 Freeman to have the last word. 22 JUDGE POTTER: You can have five minutes of 23 redirect. 24 MR. SMITH: I don't think the Judge thinks I'm 25 doing that well with Doctor Thompson. 126 1 JUDGE POTTER: He's a hard witness. 2 MR. FREEMAN: If there's something I need to 3 clear up, I'll clear it up. 4 MR. SMITH: Can I ask him about this one last 5 exhibit? 6 JUDGE POTTER: One last exhibit. 7 (BENCH DISCUSSION CONCLUDED) 8 Q. One last exhibit, and that's on PZ 1548 1911 9 there. Is that a head-to-head comparison of Prozac and 10 Trazodone? 11 A. Yes, sir. 12 Q. On overdose, psychotic depression and suicide 13 attempts? 14 A. Yes, sir. I think they've added those together. 15 Q. And is -- on Page PZ 1548 1912 a head-to-head 16 comparison of Prozac and Trazodone from the years 1982 until 17 July 1991? 18 A. Yes, sir. 19 Q. And are the reports divided by reports per 20 million, sir? 21 A. Per million prescriptions; yes, sir. 22 Q. Right. In other words, this is equalized, is it 23 not? 24 A. As best they could; yes, sir. 25 Q. All right. And that reflects, of course, that 127 1 Prozac wasn't on the market until 1988; right? 2 A. That's correct, sir. 3 Q. And then in 1988, the black is reports of 4 hostility and intentional injury on Prozac? 5 A. Yes, sir. 6 Q. And the white there on the right is Trazodone? 7 A. Yes, sir. 8 Q. In '89, the black is Prozac, white is Trazodone? 9 A. Yes, sir. 10 Q. '90, black is Prozac, and the white there to the 11 right is Trazodone? 12 A. Yes, sir. 13 Q. Same for half of '91, basically? 14 A. Yes, sir. 15 Q. And by looking at the black versus the white 16 lines, you get a comparison between the reports of hostility 17 and injury on Prozac versus reports of hostility and injury on 18 Trazodone? 19 A. Yes, sir. Per million prescriptions. 20 Q. Yeah. They're equalized as best as possible. 21 A. Yes, sir. 22 MR. SMITH: That's all I have at this time, Your 23 Honor. 24 JUDGE POTTER: Okay. Ladies and gentlemen, what 25 we're going to do is take the weekend recess as we planned 128 1 we'd only work half a day on Friday. 2 I'm going to give you the same admonition I've 3 given you before, and that is don't permit anybody to 4 communicate with you about this case or any topic connected to 5 this case. And again I emphasize that includes your family, 6 your friends as well as the news media, the radio or the 7 newspaper or the television. Don't let anybody communicate 8 with you on any topic connected with this trial. Do not 9 discuss it among yourselves and do not form or express 10 opinions about it. With that admonition, we'll stand in 11 recess till 9:30 Monday morning. 12 (JURORS EXCUSED AT 12:40 P.M.; THE FOLLOWING 13 PROCEEDINGS OCCURRED IN ROOM 148) 14 JUDGE POTTER: Can I just ask something gossipy 15 to -- for my own curiosity? The moving the courthouse was an 16 ad lib? 17 MR. FREEMAN: Absolutely. 18 MR. MYERS: I couldn't say quantum physics or 19 whatever it was, quantum mechanics. 20 JUDGE POTTER: Actually, I'm kind of a physics 21 buff or whatever, and he's technically absolutely correct. 22 MR. STOPHER: It is correct. Yeah. 23 JUDGE POTTER: But it was an ad lib, I tell you 24 that. I thought about that. 25 MR. STOPHER: Judge, I don't know when it was, 129 1 but twice today I heard some audible responses from the 2 plaintiffs. And I recognize and understand that they 3 requested that Doctor Thompson not react, and I would ask that 4 the same rule apply to them. 5 JUDGE POTTER: Yeah. Mr. Smith, when it's an 6 intended humorous thing there's nothing wrong with anybody 7 laughing, you got the jury to laugh with you about Alabama 8 English and Georgia English and that's fine, but your 9 plaintiffs were snorting or laughing or making some kind of 10 comment, and it was the courthouse line and there were a few 11 other things, and you've just got to tell them they have to 12 stop that. 13 MR. SMITH: Put on the poker face. 14 JUDGE POTTER: It doesn't have to be a poker 15 face, just so it's not audible. And it was kind of a group 16 response. Actually it happened on a couple occasions. 17 MR. SMITH: Can I get them to stand up and say, 18 "He's lying? He's lying?" 19 MS. ZETTLER: Oh, laugh, Ed. It's funny. 20 JUDGE POTTER: I notice on your witness list 21 Wernicke is listed and Weinstein is not listed, and Wernicke 22 is listed on two separate lists, so I just want to avoid any 23 problem that -- we ran into this before with a Montgomery that 24 was listed twice and they left off Ms. Montgomery or whatever 25 it happened to be. And Dunner is not on there. I don't know 130 1 if it makes any difference or not. 2 MS. ZETTLER: You think we should call these 3 people, Judge? 4 JUDGE POTTER: No. I just don't want confusion. 5 Let me go over some things. Can you have -- who is it that 6 does your witness lists? 7 MS. ZETTLER: Amy. 8 JUDGE POTTER: I don't want to tout Mr. Stopher, 9 but they got my idea right. If you could add to the summary 10 thing some kind of description, because it doesn't so much 11 help me Exhibit 1, date, Paula Warman, but an idea, because 12 you-all are keeping them. It doesn't have to be in their 13 format, but you see they have added a description to it. 14 MS. ZETTLER: Along those lines, and I don't 15 mean to be a pain about this, but I've asked Ed numerous times 16 to get us the photographs they're going to be using. 17 MR. STOPHER: I'm sorry. I had them here today. 18 I'll send them over to you this afternoon. 19 MS. ZETTLER: Thank you. 20 JUDGE POTTER: The other thing is, and it's not 21 a big deal, but also could you give me the day-by-day list? 22 MS. ZETTLER: Sure. 23 JUDGE POTTER: Yours are mostly in numerical 24 order. You had it and then, redoing it, you dropped it out. 25 You're mostly in numerical order, but we're going to come up 131 1 on 120 that are here. I mean, they have done a really good 2 job on that, and the longer we go the more likely we are to 3 get lost, so that's why I'm mentioning it now. 4 MS. ZETTLER: That's fine. 5 JUDGE POTTER: I have made a decision 6 tentatively and I want to see if anybody has anything. I told 7 the jury don't write on your exhibits because we'll take them 8 away from you before you go to the jury room. Unless somebody 9 has some strong objection, I'm going to tell them on Monday 10 that we will work out a system to where if they want them, 11 they can take their exhibits to the jury room. We've got a 12 cart that they can store it on them and a closet to put them 13 in, and we've really worked out the mechanics to where they 14 can keep the packages. Does anybody have any objections to 15 that? 16 MR. SMITH: No. Along that same line, Your 17 Honor, and I don't mean to interrupt you. It can wait, if 18 you'd like. 19 JUDGE POTTER: No. If it occurs to you now, go 20 ahead. 21 MR. SMITH: Yesterday, I ran over to Wendy's and 22 got a Coke and then came back and was smoking a cigarette in 23 the bailiff's office waiting for you to put on your robe, as I 24 do, to try to get my last cigarette down before you get back 25 on there. And Tammy Duncan -- the sheriff was there, and 132 1 Tammy Duncan came in and said, "Look, he's got a Coke. He 2 gets to drink water the entire time and now he's got a Coke." 3 The sheriff was there. I didn't respond at all. And 4 apparently her complaint was that they didn't have any Cokes 5 or any ice machines or anything. 6 JUDGE POTTER: I don't know what we can do. We 7 got them a refrigerator, we got them a microwave. Apparently 8 they were moving towards TV and video when we put a stop to 9 it. You know, she's the one at the first day I think brought 10 one of those convenience-store mugs that holds 12 gallons. 11 You know, if they want to bring in a six-pack of soft drinks 12 and put them in the refrigerator, maybe I'll mention that to 13 them. We've even got them an honor box where they can buy 14 soft drinks (sic). I think they're getting along back there. 15 If you don't want to be badgered, you'll have to smoke out 16 front where they can't see you with your Coke. 17 MR. SMITH: I usually do, but I got caught that 18 time. 19 JUDGE POTTER: Let me bring up one thing. 20 Apparently, Mr. Fuller is not going to be called; is that 21 right? 22 MR. FREEMAN: Not this week; no, sir. 23 JUDGE POTTER: Let me ask you this, because I'm 24 thinking of entering an order that anybody that Lilly won't 25 produce for them during their case and they have to read a 133 1 deposition, Lilly can't call during your case, because I 2 just -- these depositions are difficult and they are 3 convoluted. And I've been reading my little rule book on 4 order and proof, and what I can do to make things go along, 5 and I'm thinking of entering an order that -- and I wouldn't 6 do it on Mr. Fuller because he didn't come up until after this 7 occurred to me -- that if Mr. Smith says, "I'd like Doctor 8 Fuller here," you say, "Tough, you have to read his 9 deposition," then you can't call him. 10 MR. FREEMAN: If you'll recall, Judge, initially 11 I had made a different offer on some of them, but it doesn't 12 make any difference to me. We're going to call Ray Fuller in 13 our main case and we'll look at the list and see if we can 14 call any of the others, are going to produce any of the 15 others. 16 JUDGE POTTER: Okay. Because Mr. Smith, I'm 17 assuming, and I'll also enter the order that if they agree to 18 make the person available, you got to call them and can't use 19 their deposition. So what I'm saying is any of their experts 20 that you're planning to make -- and you can just do it by a 21 letter or whatever you want or do it on the record right now, 22 that you want them all produced and then you-all have to 23 decide whether you want to produce them. 24 MR. FREEMAN: What if he doesn't want them 25 produced, because I don't know? 134 1 JUDGE POTTER: Is there any expert Lilly 2 employee that -- is there anybody you want produced -- I mean, 3 is there anybody you've taken a deposition of that you would 4 rather have the deposition than the person produced? 5 MR. SMITH: No. Now, there is -- you're talking 6 about current Lilly employees? 7 JUDGE POTTER: I've been thinking about it that 8 anybody they have control of, that if you could pick somebody 9 as a former Lilly employee and say, "Mr. Freeman, will you 10 produce this person," and Mr. Freeman will say, "No, I won't," 11 or "I can't," and if he can't produce him for you he can't 12 produce him for himself. 13 MR. SMITH: Obviously the main ones are Beasley, 14 Wheadon, Heiligenstein, Wernicke. I mean, we're going to have 15 to read all their depositions if they don't produce them in 16 this case. 17 MR. FREEMAN: Does that mean that I'm forced to 18 produce them for their case even if I'm going to have them 19 here for our case? 20 JUDGE POTTER: That's what I'm saying. I think 21 it's unfair for you to make him struggle through six hours of 22 deposition and, besides that, the jury is going to get the 23 whole thing over in cross-examination as part of your case. 24 MR. FREEMAN: Can he just examine them in my 25 case if I make the representation that they're going to be 135 1 produced in my case? It's not going to hurt anybody by way of 2 motion or, otherwise, if I tell him I'm going to have Doctor 3 Fuller and Doctor Wernicke here during my case that he can 4 examine them at whatever length he needs to. 5 MR. SMITH: Are you withdrawing your motion to 6 strike Doctor Breggin or will you not file motion for summary 7 judgment on punitive damages? Are you withdrawing your motion 8 to strike Doctor Breggin? Are you representing you will not 9 file a motion for directed verdict? 10 MR. FREEMAN: I certainly will at the conclusion 11 of the case. 12 JUDGE POTTER: We may be making some progress 13 here. 14 MR. FREEMAN: But I think those motions could be 15 reserved until the conclusion of the case rather than my 16 putting up my case in the middle of yours. 17 JUDGE POTTER: We may be making some progress 18 here. 19 Mr. Smith, if he says that he is not going to 20 object to Doctor Breggin until the end of the case, at which 21 point I would strike his testimony and then everybody would go 22 home; and he's not going to move for a directed verdict at the 23 end of your case, he will do it at the end of the case, at 24 which case if I granted it we'd all go home then. And he 25 guarantees you that he's going to have whoever we're talking 136 1 about here as part of his case, and in Kentucky your 2 cross-examination can cover absolutely all topics, are those 3 people that he's telling you he will have here as that part of 4 the case, or you want to take them live instead of reading 5 their deposition or try to deal with them during your part of 6 your case? Maybe I haven't articulated it very well, but we 7 may be making some progress to get more live witnesses in here 8 and less duplication. 9 MR. SMITH: Could you agree with that? 10 MR. STOPHER: Judge, there won't be any waiver 11 if we don't move for a directed verdict at the end of the 12 plaintiffs' case for purposes of appeal? 13 MR. FREEMAN: Or if we don't move to strike 14 Breggin at the appropriate time of his deposition. 15 JUDGE POTTER: Let me just tell you this. You 16 know, I mean, I've read the brief on Mr. Breggin. I denied 17 the motion in limine and that was a gimme. I mean, it was 18 certainly safe to deny the motion in limine before the trial 19 even started. I mean, it was just a... But I did read it 20 with the idea of what I was going to do, and I am 99.9.9 21 percent that I would deny it at the time he testifies simply 22 because Mr. Smith has filled in some background. And as I 23 really understand Doctor Breggin, his testimony is going to be 24 as hypothetical as Lilly's testimony about how this thing 25 works. They've done a lot of experiments and it works this 137 1 way and this is the assumption, but nobody's ever gotten in 2 there and seen a neurotransmitter move or measured the level 3 in the synaptic cleft. 4 If I understand his testimony right, and really 5 Mr. Smith is depending on more of a statistical analysis, and 6 I assume Doctor Lord and some other people to convince a jury 7 that it's happened. Doctor Breggin's testimony, if I 8 understand it, is primarily a putative explanation of how 9 this -- the mechanics of how his side could be right. I mean, 10 if that helps anybody in trying to decide about this 11 arrangement, because I really think it's important for these 12 jurors to have live testimony. First of all, I think it will 13 shorten the trial and, second of all, really even more 14 important than shortening the trial it will give them a better 15 understanding of what's going on. 16 MS. ZETTLER: Can we have the weekend to think 17 about this, Judge? 18 MR. STOPHER: My only question was if we don't 19 move for directed verdict at the close of the plaintiffs' 20 case, are we giving up some kind of appellate right and, if we 21 are, I think the answer is obvious. 22 JUDGE POTTER: You would have to decide that. 23 The only thing I would see is that you would be giving up -- 24 let's say there's some hole in their case and they read all 25 their depositions and I should have granted a directed verdict 138 1 because there's a hole in their case. 2 MR. STOPHER: That they later fill in in our 3 case? 4 JUDGE POTTER: That they later fill in in your 5 case. 6 MR. STOPHER: I don't have a problem with that, 7 Judge. I just don't want to be foreclosed from filing an 8 appeal by virtue of that. 9 JUDGE POTTER: I don't believe you have to make 10 a motion for a directed verdict. Why don't you-all think 11 about this over the weekend. Mr. Freeman is out of town but 12 he is -- does your new house have a fax? 13 MR. FREEMAN: No, sir. It has a phone, though. 14 JUDGE POTTER: It has a phone. And see if 15 you-all can't work out some kind of agreement where he will 16 guarantee your witnesses will be here, he won't make certain 17 motions where you feel you have to put on that evidence as 18 part of your case. 19 MS. ZETTLER: Maybe we should get a list of 20 those people that they were planning on calling in their case 21 to begin with. If you're not going to call somebody like 22 Dunner, then obviously we have to work around that. 23 JUDGE POTTER: But I'm saying he may not be 24 planning on calling somebody as part of his case, but if he 25 wants to make you call them live, I'm going to give him that 139 1 right to say we'll produce Mr. So-And-So, but you can't use 2 his deposition except to impeach and whatnot. And he may not 3 be planning to call him because if you're going to read his 4 deposition, he doesn't want to call him to let you have 5 another crack at him and he's happy with the deposition, but 6 if he would rather have the person here, he could prevent you 7 from taking the deposition. 8 MR. STOPHER: Okay. Let us take a look at it. 9 JUDGE POTTER: That isn't the end of my list. 10 MR. STOPHER: Okay. 11 JUDGE POTTER: Because we have that, let's meet 12 here at 8:00 on Monday to talk about that. On Mr. Thompson, 13 you'll have an hour and a half, Mr. Smith, and then two hours 14 for Mr. Freeman, and then we'll break for lunch, and if there 15 is just one or two questions on redirect you can clean up with 16 them. But you could argue with that guy from now till 17 doomsday and unless he ad-libs again -- 18 MR. SMITH: It won't do any good. 19 JUDGE POTTER: They could put their whole case 20 in from him, you could develop your whole case from him. 21 The TV has asked if they can put a microphone up 22 and do bench conferences. Without pointing fingers, does 23 anybody have any objection if I tell them that the parties 24 would prefer they not do that, or do one of you-all want them 25 to do bench conferences? 140 1 MR. FREEMAN: I prefer they not do that. 2 MS. ZETTLER: Only because I prefer not to have 3 Chuck Olmstead commenting on our bench discussions at 10:00. 4 MR. SMITH: Let's preserve the sanctity, 5 whatever may be left of it. 6 JUDGE POTTER: I don't know what there is. 7 MR. STOPHER: I don't think that's a good idea 8 at all. 9 JUDGE POTTER: I didn't want to take the heat 10 myself; that's what it was. I don't want to have to make a 11 decision. If both of you had said no I know what I'd do. But 12 I don't know what I'd do if one of you said yes and one of you 13 said no. But if both of you said you prefer not to, I don't 14 have to think it through. Let's plan for next week. 15 SHERIFF CECIL: Excuse me. Could I interrupt 16 for one second? You know Mr. Bass, Bill Bass, the kind of 17 mysterious attorney from Houston? He wants to stay over here 18 back in the little holding cell to go through the depositions 19 and all of that. 20 JUDGE POTTER: Has anybody checked his bona 21 fides? 22 MR. MYERS: We finally tracked him down. He has 23 a case in Houston, Texas, that's very inactive. 24 SHERIFF CECIL: He can push the door to, it will 25 lock itself. 141 1 JUDGE POTTER: What time does the sheriff leave? 2 When does mental inquest close? He needs to check out with 3 mental inquest and tell the clerk in mental inquest to close 4 the door. That's part of the clerk's office. Tell him he 5 needs to report to mental inquest and tell them to check on 6 him as time goes on, just like it's part of the clerk's 7 office. Okay. Thank you. 8 (SHERIFF CECIL LEAVES) 9 JUDGE POTTER: Well, I was going to go over the 10 witness plan for next week but it may change depending on what 11 you-all do on the weekend. 12 MR. FREEMAN: Do you have your witnesses for 13 Monday afternoon? 14 JUDGE POTTER: I had another list here. The 15 only guy that I didn't know who he was -- I must have left it 16 out there because I hadn't punched holes in it. 17 MS. ZETTLER: Larry, do you have a copy of our 18 most recent list? 19 JUDGE POTTER: You'll finish Thompson. You said 20 your experts are coming in on Monday or not, Mr. Smith? Do 21 you know which one it is? 22 MR. SMITH: Probably Breggin. 23 JUDGE POTTER: Can you give them any more than 24 "probably"? 25 MS. ZETTLER: If they promise not to go to the 142 1 press and tell them he's here and make a big deal out of it so 2 we don't have to deal with the press all weekend. 3 MR. STOPHER: We don't have any interest in 4 doing that. 5 JUDGE POTTER: You-all are committing to him 6 and, as far as his name goes there's a gag order; is that 7 fair? 8 MR. STOPHER: Sure. 9 JUDGE POTTER: Who's next in your -- oh, this 10 guy I didn't know, Robert Zerbe. 11 MR. FREEMAN: He's a doctor that no longer works 12 for Lilly. 13 JUDGE POTTER: But he wasn't one of your top 12, 14 but I didn't know more than just he was -- I saw him on the 15 E-mails but... Can you give him your next one after Breggin? 16 MR. SMITH: We thought it was going to be Fuller 17 after that, but we're not sure at this time because we had 18 been -- 19 JUDGE POTTER: Well, that will get us through 20 Monday and then we'll look at where we are. 21 Okay. Anything else? 22 (PROCEEDINGS TERMINATED THIS DATE AT 12:55 P.M.) 23 * * * 24 25 143 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 144 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