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 TUESDAY, OCTOBER 11, 1994 15 VOLUME XII 16 17 * * * 18 19 20 _____________________________________________________________ 21 REPORTER: JULIA K. McBRIDE Coulter, Shay, McBride & Rice 22 1221 Starks Building 455 South Fourth Avenue 23 Louisville, Kentucky 40202 (502) 582-1627 24 FAX: (502) 587-6299 25 2 1 2 I_N_D_E_X _ _ _ _ _ 3 Hearing on Objections.................................... 4 4 * * * 5 WITNESS: DOCTOR_IRWIN_SLATER - By Deposition _______ ______ _____ ______ 6 Examination by Mr. Smith................................. 27 7 8 WITNESS: DOCTOR_PAUL_STARK - By Video Deposition _______ ______ ____ _____ 9 Examination by Mr. Smith.................................115 10 * * * 11 Hearing on Objections....................................115 12 * * * 13 WITNESS: DOCTOR_PAUL_STARK - By Video Deposition (Cont'd) _______ ______ ____ _____ 14 Examination by Mr. Smith.................................126 15 * * * 16 Hearing on Objections....................................132 17 Reporter's Certificate...................................143 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 ALSO PRESENT: 21 DR. W. LEIGH THOMPSON 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 Tuesday, October 11, 1994, at approximately 7:40 A.M., said 5 proceedings occurred as follows: 6 7 * * * 8 9 (THE FOLLOWING PROCEEDINGS OCCURRED IN THE 10 COURTROOM OUTSIDE THE PRESENCE OF THE JURY) 11 12 JUDGE POTTER: Who is Hans Weber? 13 MS. ZETTLER: Doctor Weber is the -- well, at 14 the relevant times he was the medical director, the German 15 affiliate for Eli Lilly. 16 MR. MYERS: And that's what he does now? 17 MS. ZETTLER: I wasn't sure if he had gotten 18 promoted by now. 19 MR. MYERS: No. He's the medical director in 20 Germany. 21 MS. ZETTLER: Let me tell you, 12 is okay. (To 22 Mr. Smith) Paul, I took out the part that says that you're 23 from Dallas and there's a bunch of cases. 24 14 through 18 we want in. (To Mr. Smith) This 25 is where you're establishing that he can speak English without 5 1 an interpreter. 2 JUDGE POTTER: Okay. 19. 3 MR. MYERS: Judge, on the Page 14 to 18, on Page 4 13 he answered the question as to whether he could speak 5 English, and the ensuing four pages are just a continuation of 6 that. So I don't object to obviously the question being 7 asked, but it just goes on quite a bit. 8 MS. ZETTLER: Paul, 19 through 22 is where you 9 were talking to him about the teleconference with the lawyers. 10 I put on there that it was okay to take it out. 11 JUDGE POTTER: You-all kind of struck a deal on 12 that for better or for worse. 13 MS. ZETTLER: No. I'm trying to ask him at this 14 point. It's his call. 15 MR. SMITH: I think it's significant that they 16 had this conference and that they went over these things. I 17 think it's significant in connection with his ability to speak 18 English that it be answered more than just the yes, I can 19 speak English. 20 JUDGE POTTER: There are two parts. One is four 21 and a half pages that deal with can he speak English. I'm 22 going to leave that in. My personal opinion, you're dumb to 23 put it in because it's four and a half pages and it's going to 24 lose the jury. 25 MS. ZETTLER: It's a video, Judge. 6 1 JUDGE POTTER: Then let it -- that stays in. I 2 agree with Mr. Smith that 19 through 22 could be relevant. In 3 a lot of cases it would have come in, but you-all struck a 4 deal that they weren't going to take Doctor Breggin with how 5 many times he met with you and whether you've had shadow 6 juries and I don't know all the things, so you-all kind of for 7 better or worse struck a deal. So I'm going to sustain 8 halfway through 18 -- Line 8, on 18. 9 MR. MYERS: Through Line 11 on 22, I believe. 10 JUDGE POTTER: Okay. Now, Page 48. 11 MR. MYERS: That's just some colloquy. 12 MS. ZETTLER: It's discussion between counsel. 13 I think it's the Polish comment. This is my opinion. I have 14 to check with him. 15 JUDGE POTTER: I tell you what. I make a phone 16 call, you talk. I should check with my office. 17 (OFF THE RECORD) 18 MR. MYERS: 99. 19 MS. ZETTLER: 99 is talking with Doctor Weber 20 about Doctor Benkert and his affiliation with the BGA 21 Commission A. Doctor Benkert was a suicide expert. 22 MR. MYERS: And my objection, just so it's 23 clear, doesn't relate to the discussion with Benkert but just 24 Lines 2 through 10, which I think reference a question asked 25 by the BGA. 7 1 MS. ZETTLER: (To Mr. Smith) You asked him if he 2 considered the issues of suicide raised by the BGA in regards 3 to violent, aggressive behavior as trivial and you... 4 JUDGE POTTER: All right. Now I'm beginning to 5 understand it because the other day when you did it that was 6 what we were going to use. So it's kind of the opposite now. 7 All right. 8 MR. MYERS: And, Judge, while you're looking, 9 just for the record, obviously, I'm not waiving our position 10 with respect to all this BGA information, but it certainly 11 would not have been a useful objection for me to object to any 12 and all testimony as irrelevant. 13 JUDGE POTTER: There was a motion in limine and 14 you can renew it but... 15 MR. MYERS: Yes, sir. 16 JUDGE POTTER: I'm going to overrule 99. It's a 17 continuation of getting him to admit that the BGA, it was 18 proper for them to be concerned. 19 MR. MYERS: Let me just say this, Judge. My 20 problem with the question -- and maybe we can resolve it this 21 way. The question was, you didn't consider the questions on 22 suicide and violent, aggressive behavior in connection with 23 Prozac, et cetera. There's nothing in any question about 24 violent and aggressive behavior using that terminology; the 25 question was about suicide. And I'm just not aware of any 8 1 such question, and if they want to modify the question, then 2 that's fine. 3 MS. ZETTLER: We're going to prove that suicide 4 and aggressive behavior are one and the same. 5 JUDGE POTTER: Well, I tell you what, when they 6 raised it they raised it in connection with suicide; is that 7 right? 8 MR. SMITH: No. They raised it in connection 9 with activation, Your Honor. 10 JUDGE POTTER: Wait. One or the other. 11 MR. SMITH: They raised it in connection with 12 activation and CNS stimulation, and it's our position that 13 that is the harbinger of violent, aggressive behavior. And, 14 additionally, they raised specifically the question of suicide 15 but they said activation and CNS stimulation in that list of 16 concerns and then they went ahead and mentioned suicide, but 17 those three items, and it's our position that that put them on 18 notice of this side effect profile of this drug early on. 19 JUDGE POTTER: Well, I see it one way -- I don't 20 know who's right or wrong but it's -- I mean, here it is on 21 Page 97, "Well, you don't consider -- let's face it, Doctor 22 Weber, you don't consider the questions that the BGA raised in 23 connection with fluoxetine and suicidality and violent, 24 aggressive behavior as being stupid questions, do you? 25 "No, I would not call them stupid questions, 9 1 no." This is a continuation of that. 2 MS. ZETTLER: So it's still overruled. 101 3 through 105 are about the same subject, Judge. 4 MR. MYERS: About the same subject but not the 5 same subject as 99. And 99 is overruled? 6 JUDGE POTTER: Right. All right. Mr. Myers, 7 tell me what... 8 MR. MYERS: Our position is this inquiry has to 9 do with -- about Lilly's hiring a lawyer by the name of 10 Straeter in Germany. That testimony is irrelevant to 11 testimony under which Lilly retained counsel. There's a 12 motion in limine which said that you cannot go into the 13 circumstances under which a party retained a lawyer. 14 JUDGE POTTER: Ms. Zettler. 15 MS. ZETTLER: In this case there's a fundamental 16 difference between what's going on in this testimony and the 17 motion in limine. This testimony is talking about hiring a 18 lawyer who is to give advice regarding regulatory issues back 19 in 1984. This has nothing to do with this litigation. 20 JUDGE POTTER: All right. Let me get the 21 lead-in. (Reviews document) Who is the "he" on 100? 22 MS. ZETTLER: I think it's Doctor Herrmann on 23 100, Line 6. Benkert, he's a suicide expert. 24 JUDGE POTTER: All right. (Reviews document) 25 Okay. Is Straeter ever going to appear in this scenario 10 1 again? 2 MS. ZETTLER: Yes. 3 JUDGE POTTER: Where? In what context? 4 MS. ZETTLER: Not in this one except for the 5 very end talking about Straeter contacting a portion of the 6 BGA on behalf of Lilly and something that we feel was 7 inappropriate contact. Towards the end. 252. 8 MR. MYERS: We have an objection to that part, 9 as well, so... 10 JUDGE POTTER: All right. Let me see 252, then. 11 (Examining document). 12 MR. MYERS: I don't see his name. See if this 13 index is any good. 14 MS. ZETTLER: Hold on one second. Here. See, 15 we're talking about this letter here, and it's indirectly by 16 us and what I heard from Straeter and Lode. 17 JUDGE POTTER: I'm going to sustain the 18 objection. 19 MR. SMITH: Can I be heard on that a minute, 20 Your Honor? 21 JUDGE POTTER: Either you take them or Ms. 22 Zettler take them because, you know, each person chipping in, 23 it doesn't work very well. What do you want to say on it? 24 MR. SMITH: I apologize, then. I won't say 25 anything. 11 1 JUDGE POTTER: We've been very loose. The only 2 thing I can see is this brings up a person's name. There's 3 not going to be anything out of the ordinary about him and 4 whatever slight probative value it has is far outweighed by 5 its confusion and prejudice for the jury. 6 MS. ZETTLER: Can I make one more point about 7 this? In this deposition it may appear that way, but what we 8 plan on proving is Doctor Straeter is -- 9 JUDGE POTTER: That's why I asked where is this 10 guy going to appear again. 11 MS. ZETTLER: Another deposition we have Nick 12 Schulze-Solce, who's going to testify that he was instrumental 13 in getting package insert changes in Germany changed to keep 14 him from contraindicating the drug in people who were suicidal 15 and violent aggressive. In other words, undue influence on 16 the BGA, Judge. 17 JUDGE POTTER: All this guy says is that we have 18 hired a lawyer and that he's a consultant? 19 MS. ZETTLER: Right. But it establishes how he 20 was hired from the BGA right after he left. It shows what his 21 influence on the BGA is. 22 MR. MYERS: I believe that's irrelevant and 23 covered by the motion in limine. 24 JUDGE POTTER: I agree this is not covered by 25 the motion in limine because this is 1984, and the motion in 12 1 limine dealt with preparation and whatnot for this case in 2 this trial. All this says is that they hired a lawyer, and if 3 someone else says something else bad about him later, that 4 will have to stand on its own. 113 through -- are these all 5 separate -- 6 MR. MYERS: 113 through 119 I believe all relate 7 to the same thing. I just looked at it quickly but I think 8 that's right. 9 MS. ZETTLER: The letter of concerns. 10 JUDGE POTTER: What is this all about, Ms. 11 Zettler or Mr. Smith? 12 MS. ZETTLER: Judge, what this is, is Doctor 13 Weber is talking about the original official notification from 14 the BGA regarding their concerns about the drug. Paul takes 15 him through the letter, asks him specific questions about 16 different portions of the letter and how it impacted their 17 regulatory actions related to the application. 18 JUDGE POTTER: Okay. And the objection is? 19 MS. ZETTLER: Hearsay. 20 JUDGE POTTER: Hearsay. What -- if I understand 21 it right, Mr. Myers, is what they're doing is taking Mr. Weber 22 through the German correspondence back and forth about getting 23 the drug approved; is that right? 24 MR. MYERS: Correct. In this line of 25 questioning, he's being asked about a memo that he and -- that 13 1 Doctor Schenk wrote that he reviewed, I believe, and that 2 isn't the hearsay problem, obviously since he's our agent. 3 The problem is he and Schenk are reporting what in turn the 4 BGA is reporting, and that is hearsay and there's no exception 5 to cover that. 6 JUDGE POTTER: At some point does not the letter 7 or whatever they're discussing get into this case? 8 MS. ZETTLER: Yes. Absolutely. It's a 9 translation of the official letter from the BGA. 10 MR. MYERS: I believe what they're discussing to 11 the extent the witness or any witness has personal knowledge 12 of it does get into the case, but this line of questioning, 13 the way these questions were asked raises the hearsay 14 objection. 15 JUDGE POTTER: I'm going to overrule the 16 objection. I think they're dealing with the BGA, and what 17 they thought the BGA was saying is relevant because part of 18 the criticism is going to be that they improperly pass it 19 onto -- at the FDA. 20 MR. MYERS: The next one is 126, 18 through 22. 21 MS. ZETTLER: What that's talking about, Judge, 22 is a study done by Doctor Beasley on activation versus 23 sedation, and we'll be able to prove that the numbers that 24 Paul is quoting to him there are in fact the numbers that 25 Doctor Beasley came up with. 14 1 MR. MYERS: My foundational objection is I 2 simply don't know the source of the information since it's not 3 identified in the question. 4 JUDGE POTTER: Let me see. I'm going to sustain 5 it. If it comes in later, it comes in, you get the same thing 6 here that he doesn't know -- he doesn't know, I know there is 7 a tendency but I don't think it's statistically relevant. 8 Like he says, the physicians are not identified. If they come 9 in somewhere else, they come in, but he's answered the 10 question he doesn't know. 136? 11 MR. MYERS: Yes, sir. 136 to 142 I think is 12 another block of objections on the same subject. 13 JUDGE POTTER: It looks like it because it 14 starts -- it's pretty consistent. 15 MS. ZETTLER: And it's similar to -- 16 JUDGE POTTER: Let me take a look at it. What 17 is Commission A? 18 MS. ZETTLER: Commission A is like the advisory 19 committee here to the FDA. It's part of the -- works with the 20 BGA. 21 JUDGE POTTER: Okay. So if I understand it 22 right, they've either gotten approval or their first turndown 23 or whatever from the BGA and this is going over -- 24 MS. ZETTLER: That medical opinion, their first 25 medical opinion. 15 1 JUDGE POTTER: In other words, this is going 2 over with the BGA what Lilly intends to do with the FDA. Over 3 here is all these things saying we've looked over it, we have 4 no problems, it's a healthy, good drug? 5 MR. MYERS: Yes, sir. As I read this, we've 6 received a medical comment from the BGA and the discussion is 7 simply what the medical comment from the BGA says. 8 JUDGE POTTER: I'm going to overrule the 9 objection. I see that as sort of the flip side of your proof 10 over here that everything went smooth with the FDA, and 11 they're going to prove that humans are the same everywhere and 12 another person over here had some questions the FDA didn't. 13 So the objections on Pages 136 through 142 are overruled. 14 165. 15 MR. MYERS: 165 and 166, they go together. 16 JUDGE POTTER: What are we talking about? 17 MR. MYERS: Line 16 on 165 through Line 4 on 18 166. 19 JUDGE POTTER: I mean the lead-in to it. 20 MS. ZETTLER: It's talking about whether 21 patients in the clinical trials were categorized by subtype of 22 depression, like agitated depression, retarded depression. 23 MR. MYERS: This is where Mr. Smith sought to 24 summarize what Doctor Beasley said in his deposition. And I 25 think if it's going to come in, it ought to come in through 16 1 Doctor Beasley. 2 JUDGE POTTER: I'm going to sustain 165 and 166. 3 168 is probably okay. 4 MR. MYERS: Yeah. That's just colloquy. You 5 can take that out, right, Nancy? 6 MS. ZETTLER: Yeah. Take that out. 7 JUDGE POTTER: 171. 8 MS. ZETTLER: 171. 9 JUDGE POTTER: All right. 171 sustained. It's 10 just even whoever is asking the question again says, "I may 11 not have asked the question right," and he reasked the 12 question. I don't know what no foundation meant. 193 and 13 194. 14 MR. MYERS: Those go together. 15 JUDGE POTTER: Who is Fawcett? 16 MS. ZETTLER: Doctor Fawcett is a member of 17 Lilly's drug advisory committee -- or psychiatric advisory 18 committee who has written and published an article here in the 19 United States recommending that for people who are suffering 20 from anxiety a concomitant medication be given to cut back on 21 the risk of suicide attempt. 22 MR. MYERS: My problem with the question is did 23 he know Doctor Fawcett and then the question ended up telling 24 him what Doctor Fawcett said. 25 JUDGE POTTER: Then the objection is overruled. 17 1 We're going to hear about Doctor Fawcett somewhere? 2 MS. ZETTLER: Absolutely. 199 through 210, 3 those all go together, Judge. 4 JUDGE POTTER: But it looks like there's skips, 5 but you tell me they all go together? 6 MS. ZETTLER: They just have certain objections 7 and the objections they have are all related to the same 8 thing. 9 MR. MYERS: That's correct. 10 MS. ZETTLER: Now they're talking about another 11 letter received by the BGA which was an intent to reject the 12 drug after the letter of concerns. It's the same type of 13 thing where we take them through the steps of the letter. 14 JUDGE POTTER: So if I'm going to be consistent 15 I have to overrule this, too; is that right? 16 MS. ZETTLER: Yes. 216 through 220. 17 JUDGE POTTER: Are those tied or not? 18 MS. ZETTLER: Yeah. Those are together. 19 JUDGE POTTER: What are they? 20 MS. ZETTLER: This is a discussion involving the 21 infamous Wally memo, and basically what the Wally memo is, is 22 Doctor Herrmann's review of the information contained in the 23 letter of intent to reject, so it's the same type of thing 24 again, except now they're talking to an expert. 25 MR. MYERS: Our position is that this is a Lilly 18 1 employee saying what somebody else said, and therein lies the 2 hearsay objection. 3 MS. ZETTLER: Doctor Herrmann was retained by 4 Lilly. 5 JUDGE POTTER: Just out of curiosity, are we 6 ever going to hear from Doctor Herrmann? You-all answered 7 that question for me, but I've forgotten the answer. 8 MS. ZETTLER: No. 9 JUDGE POTTER: That's the next case. All right. 10 As I understand it, there's going to be evidence that 11 regardless of when -- who Doctor Herrmann is, his report was 12 sent back to Indianapolis as kind of a summary of what was 13 going on in Germany; is that right? 14 MS. ZETTLER: Right. 15 JUDGE POTTER: Or advise about how things 16 were... 17 MR. MYERS: A summary of his report, which is in 18 part what this line of questioning refers to, was sent to 19 Indianapolis. 20 JUDGE POTTER: Okay. 21 MS. ZETTLER: Let me give you a little bit of 22 background. I think this will help. After this letter of 23 concerns and the intent to reject came out, they hired Doctor 24 Herrmann to look at the same data that the BGA came out. 25 Doctor Herrmann agreed that there were problems on this and 19 1 made suggestions on what to do to rectify those problems. He 2 was an expert that was hired, identified and relied on by 3 Lilly in relation to some of the actions they took with the 4 BGA. Doctor Schenk's review of this report is I don't think 5 hearsay because they're relying on his opinions to, in 6 effect -- an expert opinion to, in effect, conduct regulatory 7 actions after that. 8 MR. SMITH: As a direct employee. Schenk is a 9 direct employee and Herrmann is their expert. 10 JUDGE POTTER: I'm going to overrule it. And 11 part of this is both sides are treating these regulatory 12 bodies as kind of like fact finders or opinion givers. And 13 Lilly is going to rely heavily on the initial application, the 14 1991 review, and I think when you do that, they should be able 15 to show that other legitimate bodies kind of went through the 16 same process and came to a different conclusion. -24 and -29. 17 MS. ZETTLER: -24, those are two different 18 things this time, Judge. 19 MR. MYERS: That's separate, yeah. 20 JUDGE POTTER: All right. 21 MR. MYERS: The objection there is simply that I 22 didn't review what the question says he reviewed. And I 23 objected to the form at the time and they didn't change it. 24 MS. ZETTLER: Hold on a second. 25 JUDGE POTTER: It's just confusing. You asked 20 1 the same thing the next time. So 224 is sustained. 2 MS. ZETTLER: Okay. 3 JUDGE POTTER: 229. He starts asking the 4 questions. 5 MS. ZETTLER: This is talking about the Stuart 6 Montgomery suicide study, Judge, that was in issue in here. 7 MR. MYERS: And my objection has to do with the 8 fact that he said he didn't know the outcome. 9 JUDGE POTTER: The one on 229 is sustained. I 10 don't remember exactly. 11 MR. MYERS: Mr. Smith answered the question and 12 told the witness his interpretation of what the study showed. 13 JUDGE POTTER: Let's do it this way. 14 MS. ZETTLER: Just say I don't remember exactly. 15 JUDGE POTTER: It will be -- the answer at Line 16 9 on 229 will be, "Well, I do not remember exactly," and then 17 it will pick up again with "Question: Has anybody ever 18 submitted to you any type of report," in Line 23 on that page. 19 MS. ZETTLER: That's fine. 20 JUDGE POTTER: 230? 21 MR. MYERS: 230 and -31, I believe go together. 22 MS. ZETTLER: And, again, they're talking about 23 Doctor Herrmann's opinions, Judge. 24 JUDGE POTTER: Better or worse, I'm stuck with 25 it. Doctor Herrmann gets in. 21 1 MS. ZETTLER: 232 through 250 are all together. 2 Big chunk. 3 MR. MYERS: Yeah. Well, actually, Nancy, isn't 4 232 separate because he was given an exhibit at 233? 5 JUDGE POTTER: Let's look at 232. 6 MR. MYERS: It's separate. 7 MS. ZETTLER: Then that must go with the 8 Herrmann opinion thing. 9 JUDGE POTTER: Let me just take a look. 232. 10 MR. MYERS: 13 through 21. 11 JUDGE POTTER: (Reviews document). 12 MS. ZETTLER: No. That goes with this. It goes 13 with the rest of it. 14 JUDGE POTTER: I've written down something. 230 15 through -2 and 231 and 232 -- 16 MS. ZETTLER: Were Herrmann's opinions which you 17 said you're stuck with. 18 JUDGE POTTER: It's overruled. I was writing 19 down the wrong thing. The objection is overruled. Let's look 20 at 233. That may be the same thing. I don't know. (Reviews 21 document). 22 MR. MYERS: Through 250. 23 MS. ZETTLER: Since this is rather lengthy, you 24 want me to give you a little bit of background on what's going 25 on here? 22 1 JUDGE POTTER: Yes. 2 MS. ZETTLER: Okay. What they're doing here is 3 the letter that was sent by Doctor Talbott, their regulatory 4 head, the head of regulatory at the FDA, he's the one who's 5 got the main contact with the FDA. He's the one who transmits 6 all the documents to the FDA. In 1987, I sent a letter in 7 response to the approval letter that was sent out by the FDA 8 requiring them to give them information on foreign regulatory 9 activities. He sent them a letter that pretty much summarized 10 what was going on in other countries. What is going on in 11 this group of testimony is Paul is asking Doctor Weber as the 12 medical director of Germany whether or not the information 13 that was transmitted by Doctor Talbott to the FDA was accurate 14 as per what actually happened in Germany. 15 JUDGE POTTER: All right. To the extent she has 16 accurately -- if I understand it, Mr. Myers, is they've got a 17 letter that Lilly sent the FDA and it says -- I forget it, but 18 isn't there some vague term they used and then he translated 19 that term? 20 MS. ZETTLER: Right. It's the unacceptable 21 damaging effects. 22 JUDGE POTTER: And he says that means one thing, 23 and you're taking this guy through a litany of questions to 24 prove that unacceptable damaging side effects -- 25 MS. ZETTLER: Means something very specific and 23 1 that they knew what it meant back in '87 before they sent that 2 letter. 3 MR. MYERS: My problem with the line of 4 questioning is at the outset that it was even a predicate in 5 the question that he had never seen the document before. 6 JUDGE POTTER: Right. But what they're using 7 him now as is, in effect, an expert witness. I assume that 8 letter is going to come in through somebody else or another 9 time; is that right? 10 MS. ZETTLER: Doctor Talbott. Yes. It will 11 come in by Doctor Talbott. 12 JUDGE POTTER: And I think they can show it to 13 this person and say, "You've never seen this, does this match 14 up with your understanding of what went on -- with what went 15 on in Germany?" If he says no, that in itself probably 16 doesn't have any relevance, but when they bring in the other 17 person and say this letter was then submitted to the FDA and 18 put the two together, I think you come up with relevance. 19 Now, where does this stop? 20 MS. ZETTLER: 250. 21 JUDGE POTTER: I mean, the objections stay the 22 same but it looks like we start skipping around, so we may 23 change topics. 24 MR. MYERS: Well, it goes to 250. 25 JUDGE POTTER: All right. The objection is 24 1 overruled. 2 MR. MYERS: And then 252 through 259 -- well, 3 actually through the end are all the same thing, all have to 4 do with the same thing. 5 JUDGE POTTER: All right. What is -- 6 MS. ZETTLER: This goes back to that Doctor 7 Straeter, the lawyer thing. This is a letter by the general 8 manager of the German affiliate to Lilly in Indianapolis 9 talking about an action taken by the Commission A, which is, 10 like I said, a portion of the BGA. We're asking Doctor Weber 11 as the medical director whether or not he believes the actions 12 taken at the time, that that action took place. 13 JUDGE POTTER: Go a little slower and start with 14 a little more background. 15 MS. ZETTLER: Claude Bouchy was the manager of 16 the Lilly affiliate in Germany. He wrote a letter talking 17 about -- 18 JUDGE POTTER: Wrote a letter to whom? 19 MS. ZETTLER: Wrote an E-mail to -- these people 20 are in Indianapolis. These people are in Germany, all Lilly 21 employees talking about actions taken at the Commission A, 22 which is a portion of the BGA. Okay? Talking about 23 contraindications and warnings coming up on the label, et 24 cetera, et cetera. At the time that this letter was written, 25 Doctor Weber was in the United States, even though he was 25 1 medical director of the German affiliate. What we were asking 2 him in here is if he was aware of this action and whether or 3 not some of these actions are appropriate in his opinion with 4 regards to dealing with the BGA, again, regulatory issues on 5 contacts made with people at the BGA whether or not they were 6 appropriate. 7 MR. MYERS: Let me just correct one thing. 8 There may have been some other errors. At the time this was 9 written Doctor Weber was not the medical director in Germany. 10 He was on a two-year assignment in Indianapolis and had 11 another job in Indianapolis; he was not in Germany at the 12 time. And if the Court reads it, I think the Court will see 13 that he doesn't know anything about this and has never seen 14 the document. Same sort of situation Ms. Warman was in the 15 other day. 16 JUDGE POTTER: Okay. I'm going to sustain the 17 objections to 252 through -60. 18 MS. ZETTLER: What's the basis? 19 JUDGE POTTER: The basis is that he doesn't 20 answer any question other than "I don't know. You'd have to 21 tell me." And Mr. Smith, or whoever it is, is just arguing 22 with the witness over something. I mean, it's -- he doesn't 23 answer any question in a positive way. You've given him a 24 document he's never seen and, in effect, asking him for an 25 expert opinion. Assume this document to be correct, was this 26 1 proper, what do you think of it, and his whole answer is "I 2 don't know." You may want to review it, Ms. Zettler, and take 3 out the in-betweens that he hasn't objected to because it's 4 all a flow and I don't know whether to have your deposition 5 end the way you want, you may want to leave out some more. 6 MS. ZETTLER: All right. 7 MR. MYERS: That's it. 8 JUDGE POTTER: Okay. 9 MS. ZETTLER: Judge, we'd like to go through 10 Doctor Dobbs's deposition, if we could, too, because we may 11 have to read it this afternoon. 12 MR. MYERS: I really thought we were going to 13 spend all morning doing this. 14 MS. ZETTLER: We can do it at lunch. 15 JUDGE POTTER: Let's do it at lunch. You've got 16 Mr. -- 17 MS. ZETTLER: Finish Doctor Slater, then Doctor 18 Stark's video, and then we're thinking if we're running short 19 we'll put Doctor Dobbs in. 20 MR. SMITH: We can do Doctor Thompson tomorrow 21 live. 22 (RECESS) 23 SHERIFF CECIL: The jury is now entering. All 24 jurors are present. Court is now in session. 25 JUDGE POTTER: Please be seated. Good morning, 27 1 ladies and gentlemen of the jury, has anyone had any 2 difficulty with observing the admonition of not letting 3 anybody talk to you about this case or anything like that? 4 How about you, Mr. Higgs, have you had any problems? 5 JUROR HIGGS: No, sir. 6 JUDGE POTTER: Mr. Smith, do you want to call 7 your next witness. 8 MR. SMITH: Yes, sir, Your Honor. At this time 9 we'd like to continue with the written deposition of Doctor 10 Slater. 11 JUDGE POTTER: Ladies and gentlemen, I'm going 12 to remind you one more time that a deposition is sworn 13 testimony taken outside the courtroom and it's -- should 14 give -- be given the same treatment by you that you would give 15 the testimony if it was given by Doctor Slater here in person. 16 Mr. Smith, Mr. Foley. 17 (MR. SMITH & MR. FOLEY RESUME READING PORTIONS 18 OF THE DEPOSITION OF DOCTOR SLATER) 19 MR. SMITH: I'd like to resume on Page 173, Line 20 21. 21 Q. The next notation is 1-29-79? 22 A. Yes. 23 MR. SMITH: Continuing on Page 178, Line 18. 24 Q. I mean, there is a reasonable basis in that 25 instance that there was a cause and effect in connection with 28 1 fluoxetine in a particular instance without a double-blind 2 placebo controlled trial; correct? 3 A. Yes. 4 Q. You don't have to have a double-blind placebo 5 controlled study to establish in reasonable medical judgment a 6 cause and effect with a particular medication at a 7 particular -- for a particular problem, do you? 8 A. My judgment is that you can never establish 9 efficacy of a given medication without an adequate clinical 10 trial, which includes a double-blind study in most cases. In 11 some cases you can't justify it. On a humane basis, in some 12 cases you can't justify doing double-blind study. 13 Q. None of the studies that you proposed in order 14 to determine whether or not to continue clinical trials on 15 Prozac were double-blind, either, were they? 16 A. No. They were open-label studies to see whether 17 there was any possibility that one would be justified in doing 18 double-blind studies. 19 MR. SMITH: Excuse me, Your Honor. Is my 20 microphone on? 21 JUDGE POTTER: No. I think we're trying to 22 punch all the buttons and I think we may have missed the 23 little box over there. 24 All right. I think we've got all the buttons. 25 MR. SMITH: Testing. Testing. Is that better? 29 1 Resuming on Line 24. 2 Q. And you came to the conclusion that you were 3 justified in continuing on based on studies that weren't 4 double-blind placebo controlled, were you, Doctor? 5 A. Right. Everything is in steps. 6 Q. Beg your pardon? 7 A. Everything appears in steps. You have to take 8 step one before you take step two and so on. 9 Q. All right. And it says Fabre -- he is your new 10 investigator you hired to be in Houston -- "will do an 11 outpatient pilot, a strange but probably okay setup." Is that 12 correct? 13 A. Yes. 14 Q. Why did you say that Doctor Fabre's situation 15 was a strange but probably okay setup? 16 A. Because originally -- 17 MR. STOPHER: Ordinarily. 18 A. I'm sorry. -- ordinarily when a physician 19 treats patients he is paid by the patient for the treatment, 20 but Doctor Fabre treated all his patients without cost, as I 21 remember, and had his income from the people who were 22 sponsoring the trials. 23 Q. Did you know where Doctor Fabre was getting his 24 patients? 25 A. I gathered he was advertising in the newspaper. 30 1 Q. Did you have any idea who the people were that 2 were responding to those advertisements? 3 A. I imagine they were people who were depressed. 4 Q. Can you read me the notation of 2-21-79? 5 A. Doctor Herr said he was sorry that I have 6 decided to retire and so on and so forth, mentioned that Step 7 was impressed with my enthusiasm for fluoxetine. 8 Q. Who was Step? 9 A. Executive vice-president in charge of 10 pharmaceutical marketing. 11 Q. Is Step a first or last name? 12 A. Eugene Step. 13 Q. Continue. 14 A. "Johnson says 46 chance on raise, which may be 15 about right. I have told them that, if useful, I would carry 16 fluoxetine on a part-time basis." That is an interesting 17 possibility, at 20 hours per week, that is half time some 18 weeks, full time, and so on and so forth. It would be very 19 complicated. 20 Q. I don't understand where it says came up at 21 executive committee. What is that next word? 22 A. Oh, that's a long story. 23 Q. What is the word? 24 A. Impromptu. 25 Q. Came up impromptu at executive committee. And 31 1 what is after that? 2 A. Executive committee meeting. 3 Q. Oh, I thought it was two words. It says, 4 "Johnson said 46 chance of raise which may be about right." 5 What is that talking about? 6 A. I asked Doctor Herr for a raise. 7 Q. All right. 8 A. He told me I was doing great work. 9 Q. Can you read for us the notation on Page 37 10 dated 3-14-79? 11 MR. FOLEY: I have some missing pages here, 12 Paul. What page are you on? 13 MR. MYERS: I think the next designation is 200. 14 MR. FOLEY: I don't have Page 200. 15 MR. SMITH: Neither do I. Do you have 202? 16 MR. FOLEY: Yes, I do. 17 MR. SMITH: All right. Let's just go to 202 18 then. 19 Can you read for us the notation on Page 37 20 dated 3-14-79? 21 MR. FOLEY: What line are you on? 22 MR. SMITH: I'm sorry. Line 20. I'll repeat it 23 a third time. 24 Can you read for us the notation on Page 37 25 dated 3-14-79? 32 1 A. Well, it was skipped. "Visited an investigator 2 yesterday. He was ready to start as soon as we can supply 3 forms, which should be by March 28th. If a study progresses 4 according to his estimate, his optimistic projections, we 5 should have ten patients on the drug by the end of April. 6 This should give him some idea of efficacy by the NCDEU 7 meeting at the end of May. He said if fluoxetine doesn't work 8 in an open-label study, there's not too much reason to believe 9 that a double-blind study" -- and it should have said is 10 worthwhile. "He also wondered whether the transient 11 improvements that we have had reported to us may represent 12 inadequate dose. Somebody mentioned in a recent telephone 13 conversation that he's not seeing as much change in 5-HT 14 uptake as Lemberger, which makes Lou angry. Also side effects 15 in the patients receiving 60-40 regimen are not that different 16 from 30-20, so I would guess that -- will juggle doses if he 17 sees anything, but he has promised to let me know so that we 18 can file amendments with the FDA p.r.n.," which is as the need 19 arises. 20 "I think I should suggest to Bendush and Shedden 21 that I'll manage this Phase 2 fluoxetine trial and honestly 22 turn it over if open-label phase is completely discouraging, 23 but mention the tryptophan of 5-HT and joint study with 24 nortriptyline should be considered. I'll tell them and Morton 25 that I'll wind up my animal studies on September 15th and 33 1 release both Jones and Moore for other studies, that if the 2 clinical Phase 2 trial is still in progress, I'll take 3 interrupted vacation at least through February 15th, to see it 4 to an end or to Phase 3. I would like to go to NCDEU and 5 would, if they wish, recruit another psychopharmacologist." 6 Q. You say you would like to go to NCDEU. What do 7 those initials stand for? 8 A. I used to know. It's a meeting of people who 9 are interested in testing the drugs on -- in neuropsychiatric 10 things. 11 Q. Is NCDEU an in-house Lilly group? 12 A. No. It's a national meeting of people 13 interested in drugs affecting psychiatric disease. 14 Q. Did you ever report, Doctor Slater, to any 15 members of Eli Lilly and Company that your clinical trials, 16 the three clinical trials under your direction, established 17 that fluoxetine should be investigated further by Eli Lilly 18 and Company in connection with further clinical trials for 19 study of depression treated with fluoxetine? 20 A. Yes. 21 Q. Read for us the April 12, '79 memo. 22 A. "The Japanese 55-year-old physicist at Stanford 23 is still not improved while taking fluoxetine. During first 24 week, dose was reduced from 60 to 50 because of lethargy and 25 hypotension. At the end of the second week, I note in the 34 1 SCL 90 that he is nauseated. One or two weeks more and then 2 what. And this has gone on since the report of 3-27. I had 3 to sit still. I do hope that he will consent to a spinal 4 tap." 5 Q. Is it I have to sit still or it's hard to sit 6 still? 7 A. It's hard to sit still. 8 Q. All right. Tell me what you're referring to in 9 questioning this entry, Doctor Slater? 10 A. I think this is something I don't remember very 11 well, and I don't know where this patient came from. I think 12 we hoped that by spinal tap we could see whether there would 13 be an increase in spinal fluid levels of serotonin. This was 14 a patient who was depressed. 15 Q. How do you know that? 16 A. I'm inferring it from what it seems. 17 Q. What in there gives you the inference that it 18 was a patient who was depressed? 19 A. There's nothing that establishes it; it's just 20 my impression from -- I don't have any good data to back it 21 up. 22 Q. Is this patient deteriorating? Is he having a 23 problem? 24 A. My impression is that he was having some side 25 effects from relatively high doses of fluoxetine, than what we 35 1 know now, and that's all I can say. 2 Q. You say, "I note in the SCL 90 that he's 3 nauseated." What is the SCL 90? 4 A. I don't remember. 5 Q. Would that have been a clinical report form? 6 A. It could be. 7 Q. Let's turn to Page 43, the notation you made on 8 May 15, 1979. 9 A. "The meeting with Doctor Shedden and Bendush 10 went well, as did presentation with Herr staff. As of today, 11 we have fragmentary evidence of efficacy and we had best be 12 sure quickly. A slow, deliberate approach will land us a year 13 or two behind zimelidine, fluoxemine and puroxetine, and 14 therefore be worthless." This refers to the need to make a 15 decision about extending the clinical trial. 16 Q. Who is Herr's staff? 17 A. Doctor Herr was the executive vice-president in 18 charge of research and development, and I think also 19 production. He had a big job. 20 Q. And would he have been the one that would have 21 made the ultimate corporate decision on whether or not to 22 continue the clinical trials? 23 A. Right. His staff would make the decision. 24 Q. Obviously based in part on your recommendation? 25 A. On my recommendation and Doctor Shedden and 36 1 Doctor Bendush and Doctor Marsden. 2 Q. As of today, we have fragmentary evidence of 3 efficacy, and then you say and we'd best be sure quickly. I 4 get from your -- the tenor of your note that there was some 5 uncertainty in your mind or at least in this meeting in 6 questioning whether or not the product was efficacious? 7 A. Yes. 8 Q. Then you go on to say that "a slow, deliberate 9 approach will land us a year or two behind," and then you go 10 ahead and actually -- what you do is you list competitive 11 antidepressant drugs that were being developed by other 12 pharmaceutical companies at the time. 13 A. Correct. 14 Q. And you were afraid that if you took more time 15 to examine your fragmentary evidence that the other 16 competitive companies might get a jump on you that you would 17 never be able to make up; is that right? 18 A. Right. 19 Q. And if the other product came on the market 20 before fluoxetine as Prozac, it would be worthless? 21 A. Well, it would be an uphill fight, at best. 22 Q. Your word is "worthless"; is it not? 23 A. Huh? 24 Q. You wrote the word "worthless"? 25 A. Yes. 37 1 Q. On 5-18-79, would you read that notation? 2 A. "Off to NCDEU. Why do fluoxetine patients start 3 off well and then fade. Do we need L-5-HTP, Molloy says it 4 should cost twice as much as L dopa and be almost as stable. 5 I told Bendush we would need more perceptive open-label trials 6 with Diazepam and tricyclics and so on." 7 Q. "Why do fluoxetine patients start well and then 8 fade." What evidence did you have at that time that 9 fluoxetine patients were starting well and then fading? 10 A. The fragmentary evidence that I hadn't had. 11 Q. Based on the clinical trial data that you had 12 received up to May of 1979? 13 A. Uh-huh. 14 Q. Is that a yes? 15 A. Yes. 16 Q. And when you say they fade and then fade 17 specifically, what are you referring to? 18 A. The impression I was getting was that the 19 patients seemed to do well for a week or so, and then seemed 20 not to do as well. 21 Q. Becoming more depressed or exhibiting more side 22 effects? 23 A. Have a recurrence of depression. 24 Q. They would become less depressed and then return 25 to their original baseline depressive state? 38 1 A. Yes. Toward, not to. 2 Q. Now, are you talking about changing the 3 medication fluoxetine to add L tryptophan? Is that -- when 4 you say do we need L-5-HTP, is that what you mean, do we need 5 to add L tryptophan? 6 A. L-hydroxytryptophan, tryptophan, yes. 7 Q. And would that be where you would get fluoxetine 8 in conjunction with -- 9 A. Yes. 10 Q. -- L-tryptophan? 11 A. L-hydroxytryptophan. 12 Q. Was that ever done? 13 A. No. 14 Q. Why did you note that there -- that that might 15 be a possibility on something? 16 A. Because that's a precursor for serotonin. 17 Q. Did you think that that would alleviate the 18 problems of the patients who had started well and then faded? 19 A. I thought it might. 20 Q. Then you say Molloy says it should cost two 21 times L dopa; is that right? 22 A. Yes. 23 Q. It would cost two times as much to add L dopa? 24 A. No. As a chemical, the cost of this chemical 25 would be about double what L dopa would cost. 39 1 Q. The L tryptophan and fluoxetine would cost twice 2 as much as L dopa? 3 A. Uh-huh. 4 Q. Is that a yes? 5 A. Yes. 6 Q. Is L dopa an expensive medication? 7 A. Not terribly. 8 Q. That we need more perceptive open-label trials. 9 What do you refer to when you say "more perceptive open-label 10 trials"? 11 A. I'm not sure. 12 Q. What in your judgment -- on what are you talking 13 about? 14 A. I was thinking at this time that if the compound 15 only was given transient improvement, would the addition of a 16 compound that inhibited the uptake of other transmitters or 17 otherwise modified the brain function make the fluoxetine a 18 more useful drug. 19 Q. Okay. So you had fluoxetine at the time that 20 was -- I think it's been called a pure drug up to that point; 21 is that correct? 22 A. Yes. 23 Q. And that was what was one of the impugning 24 things about fluoxetine, was that it was a pure drug and 25 affected serotonin only? 40 1 A. Yes. 2 Q. As far as could be told at that time; is that 3 right? 4 A. Yes. 5 Q. And you felt like that some consideration, 6 because of the fragmentary results of the patients beginning 7 to fade, you felt like at that time in May of '79, that it 8 might be relevant to consider adding medications that affected 9 other brain chemicals to prevent this problem of the people 10 fading? 11 A. Right. 12 Q. And you mentioned tricyclics, which are other 13 antidepressants; is that right? 14 A. Uh-huh. 15 Q. And then you mentioned diazepam? 16 A. Uh-huh. 17 Q. And diazepam -- 18 A. It's a Valium and things like that. 19 Q. It's an anti-anxiety agent? 20 A. Yes. 21 Q. It's not an antidepressive at all, is it? 22 A. No. 23 Q. And wasn't it your thoughts that you were going 24 to add these Valium-type drugs to reduce the anxiety side 25 effects that had been seen in these studies? 41 1 A. We hadn't seen that, nothing. I don't see 2 anything that indicates that we were seeing anxiety. 3 Q. You don't recall that at this time? 4 A. No. 5 Q. Then why would you have been writing that you 6 had diazepam? 7 A. It was just something off the top of my head at 8 the time. It was not a proposal to anybody except to my diary 9 that we might have to do away with the purity. I had always 10 had the theory that most effective drugs have multiple effects 11 and maybe a very pure drug was not as much to go to the Holy 12 Grail as one might expect. I should say it turned out I was 13 wrong. 14 Q. All right. Continue, then, with the 5-30-79 15 entry. Would you read it for us, please. 16 A. Well, "At the NCDEU meeting last week I was 17 impressed how difficult it would be to design and carry out a 18 meaningful double-blind study with fluoxetine. I had hoped to 19 compare fluoxetine with amitriptyline but one of the 20 investigators whose name is blanked out pointed out that there 21 would be no double-blind." Would you like me to explain that? 22 Q. Yes. 23 A. All the effective antidepressants have all sorts 24 of side effects and fluoxetine is relatively free, so you have 25 a double-blind study, and the patient came in and said, 42 1 Doctor, I'm feeling so-and-so but my mouth is as dry as a 2 bone. This patient isn't on fluoxetine. That's not a 3 double-blind study. That's what this refers to. 4 Q. Do you agree with that? 5 A. Sure. I think that's what the whole world is 6 about. 7 Q. Go ahead. 8 A. In addition, I suspect that fluoxetine might not 9 affect as many patients as amitriptyline. 10 Q. Why did you -- let me stop you there. Why did 11 you have that suspicion? 12 A. I had a deep prejudice that adrenaline and 13 noradrenaline were more important neurotransmitters than 14 5-hydroxytryptamine. This goes back at least to some research 15 that I did in the '50s, but that's just prejudice; it's not 16 fact. 17 Q. I get the impression that -- just a few pages 18 before this, that you are being praised for your continued 19 work in fluoxetine and you're a staunch supporter of 20 fluoxetine and Fuller, Wong and Molloy are your boys that you 21 recruited; correct? 22 A. Yes. 23 Q. But I get the impression here in these last few 24 entries that you're beginning to have some second thoughts in 25 your own mind in your journal entry about whether or not this 43 1 pure drug, fluoxetine, might be the best drug that you could 2 come up with. 3 A. I had -- at this time had never conceived that 4 fluoxetine would be as successful of a drug as it was. 5 Q. All right. 6 A. I had hopes that it would offer benefit to some 7 patients and I thought it was a worthwhile addition to being 8 able to help people, but I didn't expect it would be as 9 successful as it is. 10 Q. And you were certainly having some mixed 11 feelings about it in May of '79 concerning it? 12 A. I had no doubt that we ought to go ahead and 13 that it was an important thing to complete, that it would be 14 effective in some patients, but I didn't think that it would 15 be as broadly effective as the then available drugs. 16 Q. Then you say, finally it dawned on me that my 17 old feelings -- 18 A. That our best bet for a successful combination 19 would be a combination of an inhibitor, norepinephrine. 20 Q. With F? 21 A. With fluoxetine. I discussed this with Fuller, 22 Stark, Morton, Raffey, Whale, Ostow and Shedden, and the 23 medical directors. I don't know who Whale is. 24 Q. Who is Raffey? 25 A. Raffey is a chemist who became the director of 44 1 the CNS group after the final reorganization which caused me 2 to retire or which preceded my retirement. 3 Q. When was the reorganization? 4 A. 1978. Ostow is an old friend of mine. 5 Q. Is he a Lilly employee? 6 A. No. No. He's a psychiatrist. I called him on 7 the telephone. That's the only time I talked to him in the 55 8 years since we graduated from medical school, and I asked him 9 did he think that an inhibitor of serotonin would be effective 10 or would it be more effective to have a combination of 11 serotonin and norepinephrine. 12 MR. MYERS: Norepinephrine. 13 MR. FOLEY: However you say that. 14 Q. And what was his response? 15 A. He thought it would be worth testing both 16 possibilities. 17 Q. Was that ever done? 18 A. No. I could never convince anybody to do that. 19 Q. Go ahead. I'm sorry I interrupted you, Doctor 20 Slater. 21 A. Clearly we must first show that fluoxetine alone 22 has some activity. This morning I'm inclined to run 23 fluoxetine against placebo for three weeks, and if nothing 24 happens, to go to amitriptyline, then compare a rate of 25 improvement of fluoxetine against placebo, fluoxetine plus 45 1 amitriptyline, and then placebo and amitriptyline. 2 MR. STOPHER: It's amitriptyline, Irv. 3 MR. FOLEY: Amitriptyline. Thank you. I might 4 not do it again. 5 MR. STOPHER: Okay. 6 Q. All right. Did you ever do that? 7 A. No. 8 Q. Why? 9 A. The oriental physicist seems to respond quickly 10 to amitriptyline after fluoxetine, when in the past he had not 11 done well on imipramine. Imipramine and amitriptyline have 12 relatively similar pharmacology. 13 Q. This is back to the physicist from Stanford? 14 A. Yes. 15 Q. What does your 6-18-79 notation say? 16 A. Oh, you want -- trying to enlist more fluoxetine 17 investigators, not happy with Fabre, wrote asking him to 18 return pills, forms and four-fifths of the grant. He had had 19 one patient at this time. 20 Q. What was your complaint with Fabre? 21 A. Apparently nothing was getting done. 22 Q. Do you specifically remember that was your 23 complaint with Fabre? 24 A. I think so. That's why I asked for four-fifths 25 of the grant be returned. I don't specifically remember. 46 1 This is the inference I'm making at this time. 2 Q. Did you have any correspondence with Doctor 3 Fabre asking him to return the pills and the forms? 4 A. It says I wrote to him and asked him. 5 MR. SMITH: At this time, Your Honor, we have an 6 exhibit. It will be Plaintiffs' Exhibit 41, which would be 7 Slater Exhibit 3, Your Honor. 8 SHERIFF CECIL: (Passing out exhibit to jurors). 9 Q. Doctor Slater, this is a letter you wrote back 10 in June of 1989. Would you take a look at that and 11 familiarize yourself with it? 12 A. Yes. That's interesting. 13 Q. Is that the letter you wrote to Doctor Fabre? 14 A. I guess so. 15 Q. Requesting that he return the pills to you as 16 you mentioned in your notation of June 18 -- 17 A. Yes. 18 Q. -- '79? 19 A. Apparently I really did write to him after all. 20 Q. And you were dissatisfied because he couldn't do 21 a single-blind study, weren't you? 22 A. I was dissatisfied that he had only done one 23 patient and we were getting nowhere fast. 24 Q. And this was a single-blind study, wasn't it? 25 A. Yes. 47 1 Q. I'm curious as to any explanation as for why 11 2 days later you would -- in this you would ask him to do a 3 double-blind study involving imipramine? 4 A. Apparently he was able to convince me that he 5 would do this. 6 Q. So, but it's definite that you hired Fabre to do 7 another study, haven't you? 8 A. Uh-huh. 9 Q. A double-blind trial; is that correct? 10 A. Yes. 11 Q. And that double-blind trial, do you recall 12 whether or not they had a comparitor drug? 13 A. No. 14 Q. Do you recall doing protocols and hiring Doctor 15 Fabre to do double-blind trials on a comparitor drug? 16 A. This is all I recall. I made a second visit to 17 Houston and talked with him. 18 Q. Between June 18th, 1979, and June 29, 1979? 19 A. I don't remember when it was. 20 Q. Tell me about your second visit. 21 A. Since I really can't place the timing of it very 22 well, my recollection is rather vague. I had the impression 23 that he thought that he had some data that suggested that 24 fluoxetine might be a useful drug. That's about the best I 25 can offer you. 48 1 Q. Well, you had asked that he discontinue the one 2 single-blind study and return the medication to you; correct? 3 A. Uh-huh. 4 Q. And return four-fifths of his grant money back 5 to you? 6 A. Yes. 7 Q. And then 11 days later, you had apparently -- is 8 it your testimony that you had talked to him and he had 9 convinced you that he could do an even more complicated study? 10 A. Yes. 11 Q. Involving more patients? 12 A. Uh-huh. 13 Q. Is that a yes? 14 A. Yes. 15 Q. Involving more paper work? 16 A. Yes. 17 Q. Involving more medications? 18 A. Yeah. 19 Q. What was it that he did or said that convinced 20 you that he was capable of taking on a bigger project when he 21 had demonstrated to you that he wasn't able to handle a 22 single-blind project? 23 A. I think you're putting an unwarranted 24 construction on -- what happened was that he had not done it. 25 It didn't prove that he was incapable of doing it; he just 49 1 hadn't done it, but he promised that he would do it this time. 2 Q. Well, at least he was incapable of getting it 3 done when you wanted it done; can we agree on that? 4 A. He had not gotten it done. He had apparently 5 gotten involved with other studies. 6 Q. And you wrote in your 6-18-79 note, not happy 7 with Fabre? 8 A. Yes. Well, I think that's reflected in the 9 letter that you have as Exhibit 3. 10 Q. Let's go back to Page 48, the 8-9-79 notation. 11 It says visited blank -- 12 A. In Nashville. I don't remember that visit. I'm 13 sorry. 14 Q. Who was that in Nashville that you visited? 15 A. This was one of the noninvestigators whose name 16 I think is still under privilege. 17 Q. Is that Doctor Sulser? 18 A. No. 19 Q. And then there's two blanks -- three blanks on 20 the second line? 21 A. That says Doctor Masco in New Port Richey. 22 Q. Whoever it was says that he can run a 20, 40, 23 60, 80 milligram of fluoxetine study, but four sets of 24 patients started in October of 1979 were taken to July 1980 25 for completion. I expressed concern that four subjects of 50 1 each dose might not be sufficient; correct? Am I reading that 2 correctly, Doctor? 3 A. Yes. 4 Q. "He seems confident that we would get answers;" 5 correct? 6 A. Right. "Could be." 7 Q. Could be is the next notation; right? Is that 8 correct? 9 A. Yes. 10 Q. Then you say, "We know that 20 rarely works and 11 that 60 causes lots of agitation, so I am going to recommend 12 that we go ahead and support the project;" correct? 13 A. Yes. 14 Q. What data did you have in August of 1979 that 15 indicated, Doctor Slater, that 20 milligrams rarely works? 16 A. I really don't remember. 17 Q. You had some data and some scientific basis at 18 the time for making that notation, did you not? 19 A. Yes. 20 Q. What data did you have, Doctor Slater, in August 21 of 1979, that 60 milligrams of fluoxetine, Prozac, causes a 22 lot of agitation? 23 A. I don't remember. 24 Q. There was scientific data, though, available to 25 you that caused you to make that notation that 60 milligrams 51 1 caused agitation; correct? 2 A. Yes. It should mention that there have been a 3 lot more detailed clinical studies that followed this. 4 Q. Let's go to Page 50, your 8-17-79 notation. 5 Would you read that, please. 6 A. The Fabre double-blind against placebo is ready 7 to go if again is improved. This Patient 103 has some corneal 8 and conjunctival lesions as well as hilar infiltrates that 9 Fabre says are probably viral in origin. Will know more when 10 he sees the patient again on August 20. 11 Q. Did you participate in doing the protocol for 12 the double-blind against placebo protocol? 13 A. Probably. 14 Q. Or for the double-blind against placebo study? 15 A. Probably. It may surprise you to understand 16 that I don't have a good recollection of something that 17 happened 15 years ago. 18 Q. Let's go to the 8-21-79 notation. 19 A. Yes. A physician called to tell us that he had 20 taken both of his -- oh, no. "A secretary called to tell us 21 that a physician had taken both his patients off fluoxetine, 22 and one was a young man with suicidal risk and increasingly 23 thought disorder that probably should be classified as 24 schizophrenic or schizoaffective. He was started on Mellaril. 25 The other must be a simple failure." 52 1 Q. Was that physician doing a clinical study in 2 connection with fluoxetine? 3 A. This was the entire extent of the clinical study 4 that he did. 5 Q. I don't understand. 6 A. These two patients, as far as I recall, are the 7 only patients he ever treated with the drug. Now, I can't 8 make any comments of what happened after 1980, but I know that 9 by the time I had retired, this was all he had ever done, and 10 I think it was just a matter of a few days of each patient on 11 medication. 12 Q. So you had this one physician, and where was he 13 located? 14 A. At a hospital. 15 Q. Well, is this physician a physician who only 16 treated two patients with fluoxetine? 17 A. As far as I can recall. 18 Q. Well, did he ever -- did these two patients ever 19 become a part of a clinical trial in connection with 20 fluoxetine? 21 A. My understanding was this was -- his intent was 22 to begin a clinical trial. He treated these patients for a 23 very short time and took both patients off the drug and never 24 did anything more in the way of a clinical trial. 25 Q. So he never completed the clinical trial? 53 1 A. Yes. 2 Q. And he was just supplied some fluoxetine by Eli 3 Lilly and Company? 4 A. He was supposed to have done a clinical trial, 5 but he didn't. 6 Q. As far as you know, the results of his studies 7 with these two patients was never included in a report of a 8 clinical trial? 9 A. Well, it would be -- the results of these two 10 trials were reported in the proper way, but they were not part 11 of a major clinical trial. 12 Q. Were there case report forms sent to this 13 physician? 14 A. Yes. 15 Q. Were case report forms sent back by this 16 physician? 17 A. Yes. 18 Q. Did you see the case report forms on these two 19 patients? 20 A. I don't remember, but I don't think so. 21 Q. How do you know that there were case report 22 forms received back on these two patients, then, Doctor 23 Slater? 24 A. See, I mentioned this note to the company and 25 they checked the company records, and these things have indeed 54 1 been reported. 2 Q. Did you read the contents of the entry? 3 A. I don't know whether we read it verbatim or 4 merely discussed the nature of the problem. 5 Q. Monday was January 20th, was it not? 6 A. 24th. 7 Q. 24th. All right. Monday was January 24th. 8 Today is January the 29th. At that time you gave the name of 9 the secretary and the name of the physician that's mentioned 10 in this notation, didn't you, Doctor? 11 A. Yes. 12 Q. So it's your testimony that at that time, on 13 Monday -- today is Saturday -- that they checked on this 14 doctor; correct? 15 A. Yes. 16 Q. And they reported to you that their research 17 indicated that case report forms were received back from this 18 doctor? 19 A. Yes. 20 Q. Did they send to you copies of these case report 21 forms on this particular individual? 22 A. No. 23 Q. Or these two patients? 24 A. No. 25 Q. Did they report to you whether or not this 55 1 physician ever did any clinical studies involving any other 2 patients other than these two patients? 3 A. No. 4 Q. Did they tell you whether or not these two 5 individuals had been reported as early terminations from the 6 clinical trials? 7 A. They just told me that they had been reported. 8 He did not tell me that the reports had been in any way 9 characterized. 10 Q. Did he tell you whether or not FDA form 1639s 11 had been filled out in connection with these two patients? 12 A. No, not specifically. 13 Q. And specifically did he tell you what type of 14 report concerning your notation of a young man with suicidal 15 risk and increasing thought disorders, what kind of report was 16 made? 17 A. No. Just the fact that a report had been made. 18 Q. But to whom, you don't know that? 19 A. To the FDA. 20 Q. They confirmed that a report to the FDA had been 21 made? 22 A. Yes. 23 Q. Did they tell you the date of that report? 24 A. No. 25 Q. Did they advise whether or not they had checked 56 1 to see whether or not any follow-up was made concerning this 2 patient who had a suicidal risk -- 3 A. No. 4 Q. -- and was having increasing thought disorders? 5 A. No. 6 Q. Did you make any follow-up, Doctor Slater? 7 A. No. I assumed that the diagnosis indicated that 8 this was not the sort of patient who was supposed to be in the 9 study, and that he had only been on the drug for a very short 10 time, and that what happened was not drug related. 11 Q. That was your assumption? 12 A. Yes. 13 Q. Because you made no investigation and don't know 14 of anybody at Lilly that did make an investigation concerning 15 whether or not these problems with this patient were drug 16 related; correct? 17 A. Yes. 18 Q. Did you ask the physician whether or not he was 19 administering this patient fluoxetine hydrochloride, Prozac, 20 according to protocols? 21 A. I don't remember talking with the physician 22 about this. My inference, from the nature of this note, is 23 that they felt that this patient, who had the suicidal 24 tendencies, was probably not the type of patient who fell into 25 the protocol as designed, that the patient was not a depressed 57 1 patient, but was schizophrenic or schizoaffective. 2 Q. Well, that's the reason I was asking, Doctor, is 3 because the protocols, most of them are -- call that the 4 medication be given to individuals who are diagnosed as 5 depressed; correct? 6 A. Yes. 7 Q. Did you send protocols to this physician? 8 A. Probably. 9 Q. Do you know? 10 A. I'm sure we did. 11 Q. Who would have been responsible for seeing that 12 physicians got protocols back in August of 1979? 13 A. I think I would have. 14 Q. Would they be sent by your office? 15 A. Yes. 16 Q. Do you have a recollection of sending this 17 physician, who treated these two patients only with 18 fluoxetine, drug kits? 19 A. Do I have a specific recollection of having sent 20 this man? 21 Q. Yes. 22 A. No. Do you remember what you sent to somebody 23 in 1979? 24 Q. Was this study a double-blind or single-blind 25 study that this doctor was performing? 58 1 A. I think it was open label. 2 Q. Were there any other physicians that you know of 3 at the time who only had two patients the subject of an 4 open-label study? 5 A. It's possible that the physician who was 6 treating the patients with a neuromuscular disorder had a 7 similar small number of patients. 8 Q. But this is a different physician than that 9 physician who was treating patients for the neuromuscular 10 disorder? 11 A. Yes. 12 Q. This is, as I understand it, Doctor Slater, a 13 physician who is conducting a clinical trial for Lilly? 14 A. Yes. Do I know of any other -- the other people 15 with whom I was in contact for the Phase 2 trial both had more 16 than two patients. 17 Q. Was this a Phase 2 trial? 18 A. Yes, I think so. 19 Q. And all of the Phase 2 trials, as far as you 20 know, excluded patients who were suicidal risks, did they not, 21 serious suicidal risks? 22 A. I don't know whether that exclusion was in the 23 protocol or not. 24 Q. Let's go back to the first paragraph on Page 51 25 of your August 21st, 1979 notation. You say one was a young 59 1 man with suicidal risk and increasing thought disorders who 2 probably should be classified as schizophrenic or 3 schizoaffective. Was this report to you that this patient 4 probably should be classified as schizophrenic or 5 schizoaffective, the report given to you by the investigator, 6 or was that a judgment you made yourself? 7 A. This was the investigator's judgment. 8 Q. And it was the investigator's judgment that the 9 the young man had suicidal risk and increasing thought 10 disorders; is that correct? 11 A. Yes. 12 Q. How long had this patient been on fluoxetine? 13 A. I don't know. I don't remember. 14 Q. Do you remember the dose -- 15 A. No. 16 Q. -- that this patient was receiving? 17 A. No. 18 Q. Do you remember the dose called for by the 19 protocol that was given to this physician? 20 A. No. 21 Q. Do you remember generally what the dosing 22 schedule was for those protocols that were used in the 23 open-label studies, as I think you said, this was an 24 open-label study? 25 A. My recollection is based not on recall, but from 60 1 what I have been reading lately I would gather that the doses 2 were between 20 and 60 milligrams per day. 3 Q. When you say by what I have been reading lately, 4 are you talking about -- 5 A. These notes that we're reviewing now. 6 Q. Do you know whether or not -- it says the 7 patient who had suicidal risk and increasing thought disorders 8 was started on Mellaril after the Prozac was discontinued; 9 correct? 10 A. That's what I was told. 11 Q. Do you know what effect the Mellaril had -- 12 A. No. 13 Q. -- on this patient's suicidal risk and 14 increasing thought disorders? 15 A. No. 16 Q. Was it your impression that the physician who 17 was administering this fluoxetine to this patient took him off 18 the fluoxetine because the patient was experiencing suicidal 19 thoughts and was having increasing thought disorders while on 20 Prozac or fluoxetine? 21 A. My impression was that the patient had had these 22 symptoms, and that he decided that the patient was not 23 appropriate for the clinical trial that had been outlined in 24 the protocol. 25 Q. Well, then, did he tell you that he had just 61 1 misdiagnosed the patient initially? 2 A. That is my impression from these notes, but I 3 have no immediate personal recall of this particular 4 situation. 5 Q. Well, your notation, Doctor, says that this 6 physician had reported to you that he had taken both of the 7 patients off fluoxetine; correct? 8 A. Yes. 9 Q. Therefore, the patient who was having suicidal 10 risk and increasing thought disorders had had fluoxetine for 11 some period of time, had he not? 12 A. Yes. 13 Q. And then was taken off fluoxetine; correct? 14 A. Yes. 15 Q. He was terminated from any study further in 16 connection with fluoxetine hydrochloride, Prozac, wasn't he? 17 A. Yes, because the diagnosis was not compatible 18 with the protocol. 19 Q. Then that patient was admitted to the clinical 20 trials in violation of the protocol instructions? 21 A. Presumably. 22 Q. But you can't say for a fact whether or not the 23 suicidal risk occurred after only he was being exposed to 24 fluoxetine, can you? 25 A. My interpretation of the note is that the 62 1 diagnosis implies that the symptoms existed before the 2 fluoxetine. 3 Q. Well, you don't say in your note that the 4 patient shouldn't have been included as a member of the 5 clinical trial, do you? 6 A. That's precisely what the note implies. 7 Q. But that's the implication; that's not what you 8 say in your note, is it? 9 A. Well, that's what it says to me now, and this is 10 written -- the diary was written for my information, so it 11 says what I think it says. 12 Q. Do you have an independent recollection, Doctor 13 Slater, of this conversation that you recorded here? 14 A. No. 15 Q. The only information you can give us is what's 16 being recorded here; correct? 17 A. Yes. 18 Q. And you can't tell us now what your impression 19 was then concerning this particular patient, can you? 20 A. Only to the extent of what I wrote. 21 Q. And that's based on, as you read it now? 22 A. Yes. 23 Q. Because you have no independent recollection of 24 the situation as it existed at the time? 25 A. Yes. 63 1 Q. Did that physician report to you whether or not 2 after the patient was taken off fluoxetine the patient 3 continued to be a suicidal risk or continued to have 4 increasing thought disorders? 5 A. I think we're getting into something we already 6 discussed about three times, and the answer is, I did not 7 discuss -- I have no recollection of having any further 8 information about this patient. 9 Q. So the answer to my question is no? 10 A. What was the question? 11 Q. The question was read back. 12 A. No. 13 Q. Did the physician report to you -- it says there 14 that the patient was started on Mellaril, which is another 15 antidepressant, is it not? 16 A. No. 17 Q. What is Mellaril, then? 18 A. It's a tranquilizer. 19 Q. During the time that you were monitoring the 20 clinical trials, did you feel it your responsibility or part 21 of your job to determine whether or not any side effects 22 reported while patients were on fluoxetine was causally 23 related to ingestion of fluoxetine? 24 A. Yes. 25 Q. And did you do that in the case of this patient 64 1 that you mentioned who had suicidal risk and increasing 2 thought disorders? 3 A. I didn't consider this a side effect of 4 fluoxetine. 5 Q. I object to the answer as being nonresponsive to 6 the question. 7 A. I think it's directly responsive. You asked me 8 whether I had monitored for side effects and I said I did not 9 consider this a side effect. 10 Q. So the answer is you did not do anything with 11 respect to this patient to determine whether or not the 12 suicidal risk or increasing thought disorders was causally 13 related to the ingestion of Prozac? 14 A. That's correct. 15 Q. Do you have any recollection of what the problem 16 was with the other patient? 17 A. No. 18 Q. Your notation there says the other must be a 19 simple failure; is that correct? 20 A. Yes. 21 Q. How were you classifying, quote, simple 22 failures? What did that mean to you as a clinical monitor? 23 A. The patient's depression did not lift. 24 Q. Well, in your judgment as a clinical monitor, 25 was that reason to discontinue a patient from the clinical 65 1 trials when their depression did not lift? 2 A. Yes. 3 Q. Do you know whether or not that patient that was 4 listed as a simple failure was reported to the Food and Drug 5 Administration? 6 A. No. I assume that it probably was, but I don't 7 know. 8 Q. Well, do you know whether or not while you were 9 present -- 10 MR. MYERS: Excuse me, Your Honor. There is an 11 objection to that question I believe that was taken out by 12 agreement. 13 JUDGE POTTER: Let me see. Please approach. 14 (BENCH DISCUSSION) 15 MR. SMITH: I apologize. That's what I was 16 reading. I wasn't going to read the other part. 17 JUDGE POTTER: Okay. 18 MR. MYERS: You'll make the change as with the 19 other, that other line of questioning? 20 MR. SMITH: Yeah. I'm not going to say that, 21 Your Honor. 22 MR. MYERS: That's fine. 23 (BENCH DISCUSSION CONCLUDED) 24 MR. SMITH: All right. I'll start the question 25 again. 66 1 Well, do you know whether or not while you were 2 present, the Lilly lawyers called to check on any details in 3 connection with what had been reported on the other patient in 4 this physician study which was a simple failure? 5 A. I have no information on that question. 6 Q. At the time you were clinical monitor of 7 fluoxetine, the clinical trials on fluoxetine, was it ever 8 reported to you, other than possibly this one notation that 9 we've discussed, that any patients who were being treated in 10 the clinical trials with fluoxetine would develop any suicidal 11 or violent thoughts? 12 A. No. Not to my recollection. 13 Q. At any time that you were employed by Lilly, did 14 you ever review the question as to whether or not fluoxetine 15 hydrochloride, Prozac, could induce suicidal ideation in human 16 beings? 17 A. No. 18 Q. Did you ever, while you were employed by Eli 19 Lilly and Company, ever investigate the notion that fluoxetine 20 hydrochloride, Prozac, could cause violent or aggressive 21 behavior in human beings? 22 A. No. 23 Q. Did you ever do any animal studies to determine 24 whether or not fluoxetine hydrochloride could induce violent 25 or aggressive tendencies in animals? 67 1 A. I think we reported that the cat showed some 2 increase in irritability, but nothing that we would call 3 violent or aggressive behavior. 4 MR. SMITH: Your Honor, at this time we had 5 mentioned the cat study earlier but we didn't have a copy of 6 it. We would request to offer as Plaintiffs' Exhibit No. 50, 7 which is Slater 1, which is the cat study. 8 SHERIFF CECIL: (Passing out exhibit to jurors). 9 Q. Your terminology is, I think, that those cats, 10 who had been friends of ours for years, started hissing and 11 growling? 12 A. Yes. 13 Q. The point is, though, Doctor Slater, that the 14 cats were growling and hissing, weren't they? 15 A. Yes. 16 Q. And you certainly characterized that as violent 17 and aggressive behavior on the part of the cats? 18 A. Not violent but aggressive. 19 Q. Although -- 20 A. Although growling and hissing may be defensive 21 rather than offensive. 22 Q. Well, they had been your friends for years. 23 A. They had been friendly, yes. 24 Q. They became, in your words, distinctly 25 unfriendly. 68 1 A. That's right. But it doesn't say whether they 2 were unfriendly in a defensive or offensive manner. 3 Q. Did you report this aggressive animal behavior 4 to Doctor Wong, Fuller or Molloy? 5 A. I don't remember. 6 Q. Did you ever discuss with Doctor Wong, Fuller or 7 Molloy any explanation for this aggressive behavior you noted 8 in class? 9 A. I don't remember. 10 Q. Well, you felt that was a significant finding on 11 your part, did you not? 12 A. I thought it was interesting, yes. 13 Q. Do you, as a scientist, have any explanation as 14 to why these -- why fluoxetine caused the aggression that you 15 saw in the cats? 16 A. No. 17 Q. Are you somewhat familiar with the serotonin 18 system, you are? 19 A. Somewhat. 20 Q. Do you have an opinion that the serotonin system 21 has some connection with our inhibitions? 22 A. With what? 23 Q. With our inhibitions. 24 A. I really don't know, and I don't have an opinion 25 on the subject. 69 1 MR. SMITH: At this time, Your Honor, we have 2 Exhibit 6 to Doctor Slater's deposition, which is Plaintiffs' 3 Exhibit 43 in this case. 4 SHERIFF CECIL: (Passing out exhibit to jurors). 5 Q. Would you review the document marked Exhibit 6. 6 A. It's interesting that I'm not even mentioned as 7 being present, and here I'm giving a report. 8 Q. Have you had an opportunity to review Exhibit 6, 9 Doctor? 10 A. I've skimmed through it quickly. 11 Q. Do you recall giving the report mentioned in 12 Exhibit 6? 13 A. No. 14 Q. You have no recollection of any of the materials 15 mentioned there? 16 A. I recognize that this was consistent with what's 17 in my diary in a general sort of way, but I have no specific 18 recollection of this meeting. 19 Q. Let's get some groundwork laid. What is that a 20 meeting of? 21 A. It's a meeting of a clinical research plans 22 committee. 23 Q. Were you on the clinical research plans 24 committee? 25 A. I don't think so. 70 1 Q. What is the date of that meeting? 2 A. January 10, 1979. 3 Q. By that time you had been -- you had agreed to 4 oversee fluoxetine clinical trials, had you not? 5 A. Yes. 6 Q. Do you have any idea why you wouldn't be asked 7 to be a member of the clinical research plans committee since 8 you were overseeing the fluoxetine clinical trials? 9 A. Yes. The clinical research plans committee was 10 presumably something that was set up among the people in the 11 medical department who were doing clinical research, and I was 12 a member of the pharmacology department, which was a 13 preclinical department, and I would not ordinarily be a member 14 of a committee of this sort. This committee was supervising 15 or overseeing all the clinical research, research on 16 antibiotics, research on whatever. 17 Q. There's no mention there in those meetings of 18 any proposed open-label study where a physician would study 19 only two patients, is there? 20 A. No. 21 Q. Beg your pardon? 22 A. No. 23 Q. Did you report there in January any agitation 24 that had been seen in the patients receiving fluoxetine? 25 A. Since I don't remember the meeting, I don't 71 1 remember what I reported. 2 Q. No. Is there anything recorded in that exhibit 3 that reflects your reporting agitation as a side effect of 4 fluoxetine? 5 A. No. 6 Q. Is there anything there that reflects your 7 earlier statements that 20 milligrams of fluoxetine was 8 worthless, and 20 milligrams produced agitation -- I mean, 60 9 milligrams produced agitation? 10 A. No, not that I can see. 11 MR. SMITH: We have at this time, Your Honor, 12 Plaintiffs' Exhibit 44, which is Slater Exhibit 7, Your Honor. 13 SHERIFF CECIL: (Passing exhibit to jurors). 14 Q. Doctor Slater, I'm going to hand you what's been 15 marked Exhibit 7 and ask you to review that with us, please. 16 A. I've read it now. 17 Q. That reflects -- what is that, Exhibit 7? That 18 reflects a clinical research planning committee meeting of 19 November 28, 1979, doesn't it, Doctor? 20 A. Yes. 21 Q. And you spoke at the meeting then, also, did you 22 not? 23 A. Apparently. 24 Q. That would have probably been the last time you 25 spoke to that austere group, would it not? 72 1 A. Yes. 2 Q. Because you retired within about a month? 3 A. Actually, I had stopped working and moved to 4 Naples and occupied my present dwelling on October 22nd, and 5 was -- had went to Indianapolis for a week for this meeting, 6 among other things. 7 Q. So do you recall that meeting, Doctor Slater? 8 A. No. I don't recall the meeting but I know 9 that's what I was doing in Indianapolis, was bringing to a 10 close my work. I had a lot of vacation time accumulated and I 11 was able to leave in the middle of October and work another 12 week, and my vacation time ran out on the 31st of December -- 13 well, no, at the beginning of the Christmas vacation, whenever 14 that was. And then I was asked to visit Doctor Bremner on the 15 west coast, so I got two extra days' pay. 16 Q. All right. Even though you may not recall a 17 meeting, do you recall the accuracy of the report? Does the 18 report appear to be accurate to you -- 19 A. Yes. 20 Q. -- in connection with the status of the work on 21 fluoxetine? 22 A. Yes. Uh-huh. Yes. 23 Q. Do you recall whether or not you had ever made 24 the clinical research planning committee aware of this study 25 involving two individuals that was discontinued? 73 1 A. Which one? 2 Q. The one where -- the one in August of 1979, 3 where one patient reported -- was reported as a suicidal risk 4 and increasing thought disorder and the other was classified 5 as a simple failure. 6 A. I do not recall specifically ever reporting this 7 directly to anybody, but probably did. 8 Q. Who would have been the individual that you 9 would have probably reported this to? 10 A. I may have mentioned it to Doctor Bendush or 11 Doctor Shedden and perhaps to Doctor Stark, but I have no 12 recollection on the subject. You have to remember that my 13 interpretation of the finding was that here was a patient who 14 should not have been put on the drug in the first place, who 15 was taken off the drug after a few days, and I didn't feel it 16 was a terribly revealing business except that the doctor had 17 made a mistake and put the wrong kind of patient on the drug. 18 Q. Did you ever do anything to minimize the risk 19 that your clinical investigators would not put the wrong kind 20 of patients on a drug? 21 A. I wrote protocols. 22 Q. That was designed to minimize the risks that 23 improper patients would be studied; isn't that correct? 24 A. Yes. 25 Q. Because what the intention was, as I understand 74 1 it, was to write a protocol that would be revealing 2 scientifically with respect to the effect of the drug on the 3 patient; correct? 4 A. Right. 5 Q. For treatment of the particular condition the 6 drug was being investigated for? 7 A. Yes. 8 Q. Is that right? 9 A. Yes. 10 MR. SMITH: Your Honor, we have another exhibit, 11 Plaintiffs' Exhibit 45, Mr. Slater's 8. 12 SHERIFF CECIL: (Passing out exhibit to jurors). 13 JUDGE POTTER: Ladies and gentlemen, Mr. Smith 14 informs me that he's got about another hour or so of 15 deposition, so why don't we go ahead and take the morning 16 recess. As I've mentioned to you-all before, do not permit 17 anybody to speak to you or communicate with you on any topic 18 connected with this trial, do not discuss it among yourselves 19 and do not form or express opinions about it. We'll take a 20 15-minute recess. 21 (RECESS) 22 SHERIFF CECIL: The jurors are all present. 23 JUDGE POTTER: Please be seated. Mr. Smith, you 24 want to continue with your testimony of Doctor Slater by 25 deposition? 75 1 MR. SMITH: Yes, Your Honor. 2 Have you had an opportunity to review Exhibit 8, 3 Doctor Slater? 4 A. Yes. 5 Q. Exhibit 8 appears to be a letter dated July 23, 6 1979, from Doctor H. A. Bartlett, M.D., the medical adviser 7 for regulatory affairs with Eli Lilly and Company; is that 8 correct? 9 A. Yes. 10 Q. And that is the letter to the Food and Drug 11 Administration; is that correct? 12 A. Yes. 13 Q. And that concerns fluoxetine hydrochloride? 14 A. Yes. 15 Q. You are listed as a recipient of a carbon copy 16 up on the top of the first page? 17 A. Yes. 18 Q. Do you recall seeing that letter? 19 A. No. 20 Q. If you will look with me at the one, two -- 21 third paragraph on Page 1 of Exhibit 8, it looks like the 22 letter is in reference to IND Protocol No. 13, doesn't it? 23 A. Yes. 24 Q. Which is a study involving Prozac, fluoxetine 25 hydrochloride at the time; correct? 76 1 A. Yes. 2 Q. The third paragraph says, "The initial dose of 3 fluoxetine will be one 20-milligram capsule given in the 4 morning of the first day. On Days Two and Three, a 5 20-milligram capsule will be given both in the morning and at 6 noon. On Day Four, two 20-milligram capsules will be given in 7 the morning, and one 20-milligram capsule at noon; correct? 8 A. Yes. 9 Q. At the investigator's discretion, this dose may 10 be continued for five weeks; is that correct? 11 A. Yes. 12 Q. It says it may be reduced if clinically 13 indicated, and in instances where the dose is reduced because 14 of agitation, diazepam may be administered as needed; correct? 15 A. Yes. 16 Q. Now, diazepam is an anti-anxiety agent, is it 17 not? 18 A. Yes. 19 Q. And did Doctor Bartlett -- 20 A. Barnett. 21 Q. -- Barnett consult with you in connection with 22 the Protocol No. 13? 23 A. I don't remember. 24 Q. You were knowledgeable concerning Protocol