1 1 NO. 90-CI-06033 JEFFERSON CIRCUIT COURT DIVISION ONE 2 3 4 JOYCE FENTRESS, et al PLAINTIFFS 5 6 VS TRANSCRIPT_OF_THE_PROCEEDINGS __________ __ ___ ___________ 7 8 9 SHEA COMMUNICATIONS, et al DEFENDANTS 10 11 * * * 12 13 14 WEDNESDAY, NOVEMBER 16, 1994 15 VOLUME XXXVII 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 Hearing in Chambers on Deposition Objections............. 4 4 Hearing in Chambers on Avowal............................ 27 5 * * * 6 WITNESS: GARY_D._TOLLEFSON,_M.D.,_Ph.D. _______ ____ __ __________ _____ _____ 7 By Mr. McGoldrick........................................ 39 Hearing in Chambers on Tollefson Cross-Examination....... 76 8 By Ms. Zettler........................................... 86 Hearing in Chambers on Tollefson Cross-Examination.......135 9 By Ms. Zettler (Continued)...............................146 By Mr. McGoldrick........................................191 10 WITNESS: DAVID_FEWELL (By Deposition Transcript) _______ _____ ______ 11 By Mr. Stopher............................................197 12 WITNESS: RICHARD_KEILMAN (By Deposition Transcript) _______ _______ _______ 13 By Mr. Stopher............................................216 14 * * * 15 Hearing in Chambers on Scheduling........................239 16 Reporter's Certificate...................................252 17 * * * 18 19 20 21 22 23 24 25 3 1 2 A_P_P_E_A_R_A_N_C_E_S _ _ _ _ _ _ _ _ _ _ _ 3 FOR THE PLAINTIFFS: 4 PAUL L. SMITH 5 Suite 745 Campbell Center II 6 8150 North Central Expressway Dallas, Texas 75206 7 NANCY ZETTLER 8 1405 West Norwell Lane Schaumburg, Illinois 60193 9 IRVIN D. FOLEY 10 Rubin, Hays & Foley 300 North, First Trust Centre 11 Louisville, Kentucky 40202 12 FOR THE DEFENDANT: 13 EDWARD H. STOPHER Boehl, Stopher & Graves 14 2300 Providian Center Louisville, Kentucky 40202 15 JOE C. FREEMAN, JR. 16 LAWRENCE J. MYERS Freeman & Hawkins 17 4000 One Peachtree Center 303 Peachtree Street, N.E. 18 Atlanta, Georgia 30308 19 JOHN L. McGOLDRICK JOHN F. BRENNER 20 McCarter & English Four Gateway Center 21 100 Mulberry Street Newark, New Jersey 07102 22 23 * * * 24 25 4 1 The Transcript of the Proceedings, taken before 2 The Honorable John Potter in the Multipurpose Courtroom, Old 3 Jail Office Building, Louisville, Kentucky, commencing on 4 Wednesday, November 16, 1994, at approximately 7:40 A.M., said 5 proceedings occurred as follows: 6 7 * * * 8 9 (HEARING IN CHAMBERS) 10 JUDGE POTTER: Okay. 103, Mr. Shea. What is 11 Exhibit 6? 12 MS. ZETTLER: It's that report that you 13 sustained the objections on yesterday. 14 JUDGE POTTER: We're talking about the thing 15 from Hartford; right? 16 MS. ZETTLER: Hartford; right. 17 MR. MYERS: It's the Hartford analysis. 18 JUDGE POTTER: Okay. I don't know if it's asked 19 100 other places or not, Mr. Myers, but I'm going to sustain 20 the objection except 104 at 21 through 105 at 2. That's just 21 his saying no, there was never a security analysis. You can 22 keep it in if you want it, but I've got a feeling it's 23 probably in there dozens of other places. 24 MR. MYERS: So that range is sustained except 25 Page 104, Line 21, through 105, Line 2? 5 1 JUDGE POTTER: Right. 2 MR. MYERS: All right, sir. 3 JUDGE POTTER: I'm going to overrule 108 just on 4 the grounds it isn't worth -- 5 MS. ZETTLER: Not worth the edit? 6 JUDGE POTTER: -- making the video technician 7 fool with it. 109, 110 is overruled. 122. I think 122, 8 although it is whatever it is, it's needed to fill out his 9 prior answer. 10 MR. MYERS: I have a question on this next one, 11 Nancy. I don't know what the objection is. In other words, 12 there's a question that starts on Line 24 on Page 128, and the 13 objection goes to Line 2 on 129. 14 MS. ZETTLER: Okay. Hold on a second. 15 JUDGE POTTER: Yeah. I think you may have the 16 wrong pages or something. 17 MS. ZETTLER: Those are the ones that are marked 18 on my sheet. I think what I have wrong is what the objection 19 should be. Hold on (reviews document). 20 JUDGE POTTER: I mean, it's a proper -- I mean, 21 it's a lead-in that -- let me go on while you're seeing if 22 there's a mistake in what you meant. 23 MS. ZETTLER: Okay. Yeah. I don't know what 24 that is, Judge. 25 JUDGE POTTER: Okay. So it's overruled. Okay. 6 1 Is Mr. Mattingly going to be called before this? 2 MR. MYERS: Before this goes in? He's going to 3 be called, Judge; I'm not for sure what the order is, but he's 4 going to testify about the meeting with Ms. Warman. 5 MS. ZETTLER: Well, also, Judge, Mr. Stopher 6 here is throwing in a lot of stuff that Ms. Warman never said, 7 like that the company didn't want to hear this. 8 JUDGE POTTER: Wait. Wait. I understand. 9 That's why I'm asking about Mr. Mattingly may provide that. 10 MS. ZETTLER: My understanding is what Mr. 11 Mattingly is going to testify to, Judge, is that it would have 12 been dangerous for Mr. Wesbecker to work the folder, that he 13 never said -- 14 JUDGE POTTER: Wait. Wait. I think we all know 15 one thing, that when we're dealing with live witnesses in this 16 case, we've got to call them before we have a clue as to what 17 they're going to say. 18 MS. ZETTLER: Yeah. Well, yeah. I think 19 consistently what's happened here is these people have backed 20 off their deposition testimony. 21 JUDGE POTTER: Exactly. Okay. What I'm going 22 to do on this one is I'm going to sustain the objection, 131 23 through 134. And, Mr. Myers, if, you know, you want to have 24 me reconsider that after I hear Mr. Mattingly, I will. 25 MR. MYERS: You want to hear his live testimony 7 1 or see precisely what his deposition says? 2 JUDGE POTTER: I mean, hear him out here, 3 because apparently that phraseology is not in his... 4 MR. MYERS: Just in terms of the phraseology, 5 Mr. Stopher is quoting on Page 131 when he asks the question, 6 closed quote, quote. 7 MS. ZETTLER: Just because he says quote in the 8 text doesn't mean it's an actual quote. 9 JUDGE POTTER: Well, I tell you what. I'm going 10 to sustain that one and you can either give me his testimony 11 or if you want to bring his deposition and he flat says that 12 then I'll reconsider it, because we've got a difference about 13 what the underlying evidence is and I'm not in a position to 14 resolve it right now. 15 MS. ZETTLER: Just to remind the Court, another 16 portion of that is what Ms. Warman said, and she never 17 testified to that. 18 JUDGE POTTER: Right. They won't get it in on 19 Ms. Warman; they may get it in on Mr. Mattingly. 20 MS. ZETTLER: Okay. 21 JUDGE POTTER: (Reviews document) Well, I can't 22 keep all my people straight, but Mr. Gosling did testify that 23 way, didn't he? 24 MR. MYERS: Yes, sir. I think that was pretty 25 clear as to the threats and the list of people. 8 1 MS. ZETTLER: Actually, I don't think -- I think 2 what he talked about was -- he ended up just saying he heard. 3 JUDGE POTTER: Well, I'm going to leave that one 4 in. If he didn't, somebody else did close enough to... I 5 mean, I heard some testimony about somebody writing something 6 down on a sheet of paper and, you know. 7 MS. ZETTLER: That was the list that he made 8 to -- for his lawyer and showed Lucas again after he was on 9 Prozac. 10 JUDGE POTTER: All right. I'm going to sustain 11 135 through 138. 139 is overruled on the grounds that it's 12 not worth making the person make the cut. The answer was, 13 "I'm sorry. I don't know what you mean." 14 MS. ZETTLER: You have to remember this was done 15 about a week and a half ago when I still had some brain cells 16 left, Judge. I was a little obsessive about it. 17 JUDGE POTTER: Exactly. As the trial goes on, 18 things become less and less -- 19 MS. ZETTLER: Important? 20 JUDGE POTTER: Minor things become less and less 21 important. 22 MS. ZETTLER: Right. 23 JUDGE POTTER: I'm going to sustain the 24 objection to 139 through 141. Has Mr. Metten testified? 25 MR. MYERS: Yes, sir. 9 1 JUDGE POTTER: Did he say pretty much what's 2 said in here or not? 3 MS. ZETTLER: No. Judge, the only thing that's 4 been established here as far as Mr. Wesbecker bringing a gun 5 into the plant is that one occasion with Lucas in late '86, 6 early '87. Now he's talking again about January of '88. Now, 7 I don't know if he's referring to the same incident here. 8 JUDGE POTTER: Well, let me go get my notes on 9 Mr. Metten and see what at least I think he said. 10 (JUDGE POTTER LEAVES AND REENTERS CHAMBERS) 11 MS. ZETTLER: I'm not entirely sure that 12 Mr. Metten has testified. 13 MR. MYERS: He has. 14 JUDGE POTTER: He was the 46th witness. 15 MS. ZETTLER: That's why I don't remember them. 16 After a while they all blend. 17 JUDGE POTTER: That's how I've tried to keep 18 track of them. (Reviews document) Okay. My notes say he said 19 someone ought to do away with Shea. 20 MS. ZETTLER: But that's different than -- 21 they're trying to imply that there was a separate incident 22 with bringing the gun into the plant in 1988, as opposed to 23 late '86, early '87. I think he's trying to capitalize on a 24 mistake he made here on his dates, Judge. 25 MR. MYERS: Well, he clearly testified that 10 1 there was a threat made. 2 MS. ZETTLER: Right. But what I'm saying is 3 that, first of all, Mr. Metten testified that he had heard 4 this. He testified, as far as the gun is concerned, that this 5 wasn't something that Mr. Wesbecker said to him directly. He 6 may have said that something ought to be done with Shea, but 7 that's a big difference, Judge, and now they're trying to 8 create a new incident here that just didn't occur. 9 JUDGE POTTER: Okay. She's convinced me that 10 he's put together two parts -- two separate incidences in such 11 a way as to make them a different incident. Now, the second 12 half of it is in a different situation, isn't it, Ms. Zettler? 13 MS. ZETTLER: Well, again, it goes back, Your 14 Honor. He's coming up with dates all over the place here, 15 Judge. 16 JUDGE POTTER: All right. Now, wait a second. 17 There's a gap. You pick up 143. So the one in between is 18 correct. 143, Line 3 -- no. 19 MS. ZETTLER: Actually, now that I look at that, 20 Judge, let's go back on that other one. It's not correct. I 21 missed this. He says February '88 now Lucas tells him. I 22 think Mr. Lucas testified that this was sometime in late '86, 23 early '87, and that's what the presumption has been, that 24 that's when this occurred, and I think Mr. Stopher has made a 25 point -- 11 1 JUDGE POTTER: Well, that's close enough. Let 2 me see 143. All right. The 141, 142 is sustained; the 143, 3 144 is overruled. 145. 4 MS. ZETTLER: Just for the record, Judge, the 5 problem we have with 143 and 144 is Mr. Stopher -- these 6 issues are very much in dispute. Mr. Stopher has spent a lot 7 of time in this deposition creating threats, and now he's 8 trying to tie them together by just simply stating these are 9 true. I mean, they're very much in dispute. This kind of a 10 question would draw an objection which would be sustained in 11 this courtroom, Judge. 12 JUDGE POTTER: All right. Let's do it this way, 13 then. On the 143, 144, I'm going to overrule it as to 143, 14 Line 4 through 8, and sustain it at 143, Line 9, through 144, 15 Line 2. In other words, he gets to ask the first question and 16 answer and then the rest of it he's arguing with him about 17 whether it's true or whether it's a hypothetical. 18 MR. MYERS: So on 143, we're going to read 19 Lines 4 through 8? 20 MS. ZETTLER: Uh-huh. The rest of it is out. 21 JUDGE POTTER: Right. Mr. Gosling testified for 22 such a long time. What is wrong? 23 MS. ZETTLER: Mr. Gosling did not testify about 24 the bomb, Judge. Mr. Gosling, if you remember, is the 25 gentleman that kept going like this when Paul was reading to 12 1 him and he needed to talk to you. He ended up testifying, 2 compared to his deposition, to relatively little of substance. 3 MR. MYERS: Judge, in this other line of 4 testimony Mr. Senters clearly testified about these threats, 5 and particularly Mr. Gosling said he was going to put this 6 bomb near this tank, but it was too expensive, it might blow 7 the whole place up. And then Mr. Senters clearly came in and 8 testified about this list. 9 MS. ZETTLER: It said that in his deposition. 10 JUDGE POTTER: Wait. Wait. Wait. (Reviews 11 document) Bomb. All right. 145 through 148 are overruled. 12 MS. ZETTLER: Can I point out one thing on 148, 13 Judge? 14 JUDGE POTTER: Uh-huh. 15 MS. ZETTLER: Lines 11 through 24, Mr. Stopher 16 says, "Let's assume that many employees have testified that 17 they took these threats seriously." I think what the 18 preponderance of the evidence is -- 19 JUDGE POTTER: Well, that's... All right. So 20 it's overruled except 148, Line 11 through 24; that is a 21 different topic. All right. Page 4. 148 and 149 are 22 overruled. 149 through 150 are overruled. 151. 23 MS. ZETTLER: Mr. Croft is the gentleman that 24 we've been disputing about with the alleged heart condition, 25 Judge. He has not testified. 13 1 JUDGE POTTER: So he hasn't testified. All 2 right. Let's do this. The last part of it is a different 3 question. 4 MS. ZETTLER: Which part, Judge? 5 JUDGE POTTER: 153, Line 17. 6 MR. MYERS: Line 17? Because the first part 7 refers to Mr. Croft's deposition. 8 JUDGE POTTER: You've got a different kind of a 9 wrap-up question. The first part, Page 151, Line 3, through 10 153, Line 16, is sustained, and it's overruled as to Line 17 11 through 154, 2. 12 MS. ZETTLER: Mr. Likins has not testified and 13 has not even been put on a list at this point, Judge. 14 MR. MYERS: I think he's on one of our multitude 15 of lists. He's on one of the other earlier ones. 16 MS. ZETTLER: Well, then, he should have been 17 called by now. 18 JUDGE POTTER: All right. I'm going to sustain 19 it because even if he comes in and testifies, his testimony 20 will be there. 21 MS. ZETTLER: That sort of raises another issue, 22 Judge, that I'd like to take up after we're done with this on 23 these witness lists. 24 JUDGE POTTER: Let's just wait till we get 25 there. 14 1 MS. ZETTLER: All right. 2 MR. MYERS: These next two groups are about the 3 same thing, Judge, the threat file that Mr. Throneberry 4 testified about and then about the document retention policy. 5 MS. ZETTLER: Our major problem with this -- 6 JUDGE POTTER: This is one where we have a whole 7 batch and then -- 8 MR. MYERS: 155 and 156, and then 156 through 9 164, and then it looks like Nancy put some specific additional 10 objections. 11 JUDGE POTTER: Right. Specific objections. 12 MS. ZETTLER: Right. 13 JUDGE POTTER: All right. Well, let me take a 14 look at it. We haven't heard from Mr. Smithers? 15 MS. ZETTLER: No. He was in another earlier 16 list and, actually, I believe Mr. Stopher said that he does 17 not intend to call him. He's interspersed throughout this 18 whole thing, Judge. I believe Mr. Stopher in Mr. McCall's 19 deposition just voluntarily withdrew the stuff about the phone 20 calls because there was no way it could be connected up. 21 JUDGE POTTER: Okay. As I understand it -- 22 okay. I'm going to overrule the objection through 160. 23 MS. ZETTLER: Even with Mr. Smithers not 24 testifying in this case? 25 JUDGE POTTER: Mr. Smithers is a small part of 15 1 this. I mean, if he testifies or not, the idea is he's 2 getting him nailed down that he's looked for it, can't find 3 it. And then 161, when we pick up with the tape that will 4 just be confusing so I'm going to sustain that. 5 MR. MYERS: So starting at Line 7 on 161, after 6 that you're sustaining it? Because 161 goes down to Line -- 7 JUDGE POTTER: Well, I tell you, why don't you 8 stop in the middle of his answer. Just leave the whole tape 9 out, "I would as far as turning over a tape." 10 MR. MYERS: All right. So that is actually 11 through 160. Okay. 12 MS. ZETTLER: Judge, Mr. Smithers is not going 13 to testify like represented in here or they would have called 14 him. 15 JUDGE POTTER: Right. But Mr. Smithers is a 16 very small part of this thing. That is just a lead-in to say 17 somebody's testified you boxed the stuff up, have you looked 18 for it. 19 MS. ZETTLER: He's arguing with him here 20 continuously in trying to accuse him of destroying documents, 21 and then he's trying to bolster that testimony with this other 22 person's testimony who's not even going to be here. 23 JUDGE POTTER: Okay. All right. 164 through 24 167. 25 MS. ZETTLER: All right. So these other 16 1 leading, argumentative, et cetera, are all out, too? 2 JUDGE POTTER: Yeah. They're covered in the... 3 MS. ZETTLER: All right. 4 JUDGE POTTER: Mr. Myers, just there's a typo. 5 The 164 should run through Line 8. I mean, it says 8 one 6 place and 7 another. 7 MR. MYERS: I'm sorry? 8 JUDGE POTTER: That should be an 8. It says 8 9 down here. 10 MR. MYERS: Oh, yes, sir. Thank you. 11 JUDGE POTTER: Have we heard from Denise Hall? 12 MS. ZETTLER: Denise Hall, no. 13 JUDGE POTTER: Is Ms. Hall going to be here? 14 MR. MYERS: I think that we're going to -- she's 15 going to be a witness. 16 MS. ZETTLER: Well, she's sure not on any 17 current list and we're pushing eight weeks of trial now. 18 MR. MYERS: We have a lot of witnesses. 19 MS. ZETTLER: And, again, that doesn't mean that 20 she's got -- 21 JUDGE POTTER: All right. Okay. The 164 22 through 167, I'm going to sustain it. It's just too likely to 23 be error if I don't do it the other way, particularly since 24 she hasn't testified. 25 MS. ZETTLER: Judge, I might be able to save you 17 1 a little time on this one. This testimony is like the 2 testimony you struck out of Mr. McCall's. 3 JUDGE POTTER: Well, let me just -- Mr. Myers, 4 the opening lead-in is, "Let me assume that Standard Gravure 5 in this case has employed the services of a security expert 6 named Robert Shallow." Do I have to read any further? 7 MR. MYERS: I'd like the Court to read further. 8 JUDGE POTTER: Okay. Let me read through it. 9 I'm going to sustain 171 through 177. 10 MR. MYERS: Judge, we've quit reading at this 11 point. 12 JUDGE POTTER: All right. If they've quit 13 reading by 187, the Plaintiff can read. 14 MS. ZETTLER: But it's a video, Judge. 15 JUDGE POTTER: Well, all right, just play it. 16 MR. MYERS: You want me to put it in, Judge? 17 JUDGE POTTER: Well, unless you have some 18 objection to it since it's a video. I mean, I don't know how 19 they can do it. I mean, do you want to stop the machine and 20 have them punch the button to go forward? 21 MR. MYERS: Here's the problem I have. This is 22 a line of questioning starting at 187 that was done -- 23 JUDGE POTTER: By whom? 24 MR. MYERS: -- by Mr. -- let's see. 25 Mr. Alexander asked some questions starting at 178. 18 1 MS. ZETTLER: It doesn't matter who asked the 2 questions. 3 MR. MYERS: I'm just giving the Court some 4 background. 5 JUDGE POTTER: That's all right. 6 MR. MYERS: And then Mr. Carroll did some 7 examination, so this examination is both by Mr. Alexander and 8 by Mr. Carroll, these three ranges of pages here. 9 MS. ZETTLER: And that's an objection? 10 MR. MYERS: No. That's just some background as 11 to what happened. 12 JUDGE POTTER: All right. I tell you what. I 13 think what you need to do, Mr. Myers, is -- I don't know how 14 much in between here is designated but I assume probably most 15 of it. If you want something else in this last part to be 16 designated because of theirs -- 17 MR. MYERS: I don't want anything to be 18 designated because of theirs, but the subject matter of this 19 testimony, the Court has ruled out a number of the 20 objections -- has ruled out some of the testimony on Mr. Shea 21 giving opinions as to adequacy of security in our questioning, 22 then these guys come back and ask him the same types of 23 questions that the Court has already ruled out. 24 JUDGE POTTER: So you have objections to it 25 on -- okay. I understand. You have objections to it that 19 1 it's objectionable? 2 MR. MYERS: Yes, sir. 3 JUDGE POTTER: All right. 4 MR. MYERS: I tell you what. I'll agree to 187 5 through 189. 6 JUDGE POTTER: Okay. I was going to -- you need 7 to do it before I read them. I'm going to leave in 191 8 through 193. This is just his -- when I put sustained that 9 means it's in. 10 MS. ZETTLER: Can we just make sure with one 11 clarification here, that 191 through 193 starts at Line 25 on 12 Page 191, that he doesn't put in that "Wayne Carroll, I 13 represent Hall Security." 14 MR. MYERS: I see the line. 15 MS. ZETTLER: I just want to make sure there's 16 no inadvertent mistakes. 17 JUDGE POTTER: Okay. Throneberry doesn't work 18 for him; it's McCall that still works for him? 19 MR. MYERS: Yes. That's right. 20 MS. ZETTLER: Right. 21 JUDGE POTTER: Okay. They can read 203 and 204. 22 MR. MYERS: Judge, we had one thing that was 23 still open from yesterday, which was that Page 45 to 48, which 24 had to do with the personnel policy manual that the Court held 25 open. 20 1 MS. ZETTLER: I think you later on went and 2 sustained the objection, Judge. 3 JUDGE POTTER: Well, I have it blank. It looks 4 like I changed my mind. I have something and then I have it 5 crossed out. This is the one where you -- when you produced 6 the exhibit it was a big, fat thing, right, that had lots of 7 pages? 8 MS. ZETTLER: Right. And then the one that he's 9 gotten in is -- 10 MR. MYERS: Is the bomb threats and the gun 11 policy. 12 MS. ZETTLER: -- two or three pages out of this 13 entire thing which is double-sided, Judge. 14 (SHERIFF CECIL ENTERS CHAMBERS) 15 SHERIFF CECIL: Excuse me. Judge, Sue just 16 called. A witness named James Croft, I think that you-all 17 were supposed to have in, he called this morning and says that 18 he has a heart condition and that he cannot testify. His 19 doctor was supposed to have sent a letter, and Tricia, Mr. 20 Stopher's secretary, was supposed to have taken care of it. 21 But he called this morning and said he will not be here. 22 JUDGE POTTER: Well, give that to Mr. Myers, and 23 we'll just have to deal with it. My current ruling is that 24 the Defendants cannot read his deposition. Now, if you-all 25 want to make a motion for me to have a sheriff go out and 21 1 arrest him or something, we'll just have to take that up as it 2 comes. 3 MR. MYERS: I'll take that up with Mr. Stopher. 4 Thank you for that report. 5 SHERIFF CECIL: Yes. 6 (SHERIFF CECIL LEAVES CHAMBERS) 7 JUDGE POTTER: All right. There is no real 8 contention that that thing isn't the full personnel manual 9 that parts have been introduced from; right? 10 MR. MYERS: No. I mean, it is exactly what it 11 is, and parts have been introduced in evidence. 12 JUDGE POTTER: Okay. I'm overruling the 13 testimony, the objection. I don't know that that necessarily 14 means the document will come in at trial. 15 MS. ZETTLER: Well, actually, Judge, if you're 16 going to overrule that and let him just talk about certain 17 parts of this, we want the whole thing in. 18 MR. MYERS: That's just a short portion. 19 JUDGE POTTER: If I understand this, it's I'm 20 showing you what's the personnel manual. They haggle around 21 about whether it's the personnel manual. And then he says, 22 "I can't find any reference in here to which employees are 23 encouraged to require or to report anything about safety and 24 security." 25 MS. ZETTLER: That's exactly the point. Then 22 1 they're not given the entire document. I want the whole 2 document in. 3 JUDGE POTTER: All right. You want the whole -- 4 and he says, "No, I can't see it." 5 MS. ZETTLER: No. He doesn't even look at the 6 whole thing, Judge. 7 JUDGE POTTER: And he says, "I agree with you as 8 a lawyer." Was there something in there? 9 MR. MYERS: No. He said if Mr. Throneberry gave 10 it to you then, yes, sir. 11 MS. ZETTLER: I'm talking about the information 12 that he's talking about. 13 JUDGE POTTER: He says, "If you tell me there's 14 nothing in there, I'll believe it." Well, if you want it 15 in... 16 MS. ZETTLER: Yes, I want it in, the whole 17 thing, the entire page-to-page thing. 18 MR. MYERS: Can I ask just a planning question? 19 I'm going to have Mr. Mattingly's deposition brought over 20 here, Judge, because that's the only thing that's outstanding, 21 and if at the morning break we could just look at that because 22 I need to get this tape edited. 23 JUDGE POTTER: Okay. 24 MR. MYERS: And the other thing is -- 25 MS. ZETTLER: At the morning break I may be 23 1 preparing for my cross, Judge. 2 JUDGE POTTER: Okay. Well, we'll do it at 3 lunch, then. 4 MR. MYERS: The only other thing, Judge, is we 5 need -- I know the ball is still in the air on Mr. Croft based 6 on this morning's report. We have designations out for 7 Mr. Rakow and Mr. Rothenburger, and we need to get those 8 objections, and we need to have a hearing on Mr. Jackson and 9 Mr. -- 10 MS. ZETTLER: Jackson I thought was done. 11 Didn't we do Jackson yesterday? 12 MR. MYERS: No, we did Fewell. 13 MS. ZETTLER: Well, we did someone else; right? 14 MR. MYERS: No, we did Fewell yesterday. We 15 never got to Jackson. 16 MS. ZETTLER: One of them is already done. You 17 told me yesterday we had two people left or three people left, 18 mcCarty, Shea and somebody else. 19 MR. MYERS: I didn't write anything on my 20 designation, so we haven't had a hearing on Mr. Jackson. 21 There are just some things outstanding because in order to 22 move things along, Judge -- 23 JUDGE POTTER: Okay. Well, we'll look at it at 24 lunchtime and do Mattingly. 25 MR. MYERS: I'll have that brought over. 24 1 JUDGE POTTER: Why is -- why are we doing 2 Mattingly's deposition? 3 MR. MYERS: No. No. I'm going to bring it over 4 so that you can look at that reference to see if Mr. Stopher 5 quoted it correctly for purposes of this. 6 JUDGE POTTER: Oh, okay. 7 MS. ZETTLER: Let me clarify something here, 8 Judge. Mr. Rothenburger is here in Louisville. They are 9 supposed to prove that he is unavailable. That's the guy who 10 supposedly is in the hospital with leukemia, okay, but they 11 haven't proven that, they've just said it. And the second is 12 we have an outstanding motion on Rakow's deposition as a 13 whole. So I think before we worry about going over objections 14 we should resolve those two issues, and if they have a 15 problem, then -- 16 JUDGE POTTER: I'm in the process of reading 17 Mr. Rakow's deposition. 18 MR. MYERS: And if I could just -- this doesn't 19 have to be on the record; I'm just asking Ms. Zettler. 20 (OFF THE RECORD; HEARING IN CHAMBERS 21 CONCLUDED; THE FOLLOWING PROCEEDINGS 22 OCCURRED IN OPEN COURT; BENCH DISCUSSION) 23 MS. ZETTLER: Judge, we still have one 24 outstanding matter to take up before we begin about that 25 study. 25 1 JUDGE POTTER: Show me where he talks about it 2 or tell me where he talks about it. 3 MR. MYERS: Here this was marked as Defendant's 4 Exhibit 421, that was the published paper that was published 5 at the end of this year. I can represent to the Court that in 6 the deposition of Doctor Charles Beasley this document, first 7 page of which is PZ 210 8374, the last page is 210 8399, was 8 produced for Doctor Beasley's deposition. 9 Additionally, in the deposition of Doctor 10 Beasley, he was examined at some length about the subject at 11 Pages 131 to 156 and then at 180 and 181, and I brought 12 excerpts of that transcript for the Court and have given that 13 to Ms. Zettler and Mr. Smith. 14 Additionally, from the deposition of Doctor Gary 15 Tollefson, I can represent to the Court that the document -- 16 here it is, another draft of the document with the first page 17 PZ 244 13162, last page PZ 244 13189, was produced in Doctor 18 Tollefson's deposition and that Doctor Tollefson was examined 19 during the course of his deposition. 20 JUDGE POTTER: What are we talking about? The 21 April 7th draft was produced during Doctor Tollefson's 22 deposition? 23 MR. MYERS: Yes. The only reason we're talking 24 about Doctor Beasley is because the question is was there a 25 disclosure, and there has been a disclosure in Doctor 26 1 Beasley's and Doctor Tollefson's deposition, both of whom are 2 authors on the paper. 3 JUDGE POTTER: Let me see his deposition. 4 MR. MYERS: Doctor Tollefson? 5 JUDGE POTTER: Yeah. 6 SHERIFF CECIL: All rise. The Honorable Judge 7 John Potter is now presiding. All jurors are present. Court 8 is now in session. 9 JUDGE POTTER: Please be seated. 10 I don't understand. This is Doctor Beasley's 11 paper or there are two papers? 12 MR. MYERS: No. That is one of the papers to 13 which he made reference on which he and Doctor Tollefson are 14 authors, and the other papers that I gave the Court are drafts 15 of that same paper which were produced for both Doctor 16 Beasley's deposition and Doctor Tollefson's deposition. 17 Doctor Beasley's deposition was taken in May. The first two 18 installments in Doctor Tollefson's deposition was taken in 19 July and the subject originally came up in Doctor Beasley's 20 deposition, and then it was taken up again in Doctor 21 Tollefson's deposition. 22 JUDGE POTTER: Ms. Zettler, is there anything 23 you want to say? 24 MS. ZETTLER: Yes. First of all, the absence of 25 use attempts during pharmacotherapy for depression, Number 27 1 One, was never produced to us for -- before either Doctor 2 Beasley's or Doctor Tollefson's deposition. We surely would 3 have questioned him on it and attached it to the deposition. 4 References were made to an activation study, one of which was 5 the Beasley 38-percent document that you have not let us use 6 in this case. If you look at Doctor Tollefson's deposition on 7 Page 159, he talks about something to the effect that there is 8 an association -- 9 JUDGE POTTER: We're going to have to take a 10 brief recess to sort this thing out. 11 (BENCH DISCUSSION CONCLUDED) 12 JUDGE POTTER: Ladies and gentlemen, I'm going 13 to start the morning off with a recess or you-all are going to 14 be sitting there for a while. We'll take a recess. As I've 15 mentioned to you-all, don't talk about this case; don't form 16 or express opinions about it. Go to the jury room until we're 17 ready. 18 (HEARING IN CHAMBERS) 19 JUDGE POTTER: Let's start this way. Mr. 20 McGoldrick, why don't you get Doctor Beasley in here -- 21 MS. ZETTLER: Tollefson. 22 MR. McGOLDRICK: Tollefson. 23 JUDGE POTTER: Tollefson, I'm sorry. And in 24 four minutes take him through his testimony about what he's 25 going to say. 28 1 MR. McGOLDRICK: Yes, sir. 2 (MR. McGOLDRICK LEAVES CHAMBERS AND REENTERS 3 WITH DOCTOR TOLLEFSON) 4 JUDGE POTTER: Have we got a full Doctor 5 Tollefson's copy? 6 MS. ZETTLER: Yes. Right here. 7 JUDGE POTTER: Let me read one thing first. 8 Okay. Doctor, I'll remind you you're still 9 under oath. You want to answer Mr. McGoldrick questions. 10 11 AVOWAL_EXAMINATION ______ ___________ 12 13 BY_MR._McGOLDRICK: __ ___ __________ 14 Q. Doctor, did you at Lilly study whether certain 15 adverse-event clusters were related to suicidality on Prozac? 16 A. Yes, I did. 17 Q. And approximately when did that occur? 18 A. That analysis was started in 1991. 1991. 19 Q. Okay. And very briefly, what did you do? 20 A. We were interested in testing a hypothesis of 21 whether or not there might be a higher frequency or 22 concurrence of an adverse event and the emergence of 23 suicidality or an act of suicidality then seeing either one 24 alone; in other words, was there a relationship between the 25 two, and that is in fact what we tested. 29 1 Q. And, again, briefly, what method did you employ? 2 A. We did an analysis looking at the frequency or 3 the incidence of emergences of suicidality or acts of 4 suicidality, and essentially analyzed the frequency of those 5 events with the frequency of a temporal or time-related 6 association with an adverse event, and there were nine -- 7 actually nine adverse event clusters that we looked at. 8 Q. And with respect to that, what were the results 9 insofar as activation and suicidality or similar categories? 10 A. Well, in no cases were there a higher frequency 11 of an adverse event associated with suicidality than seeing 12 suicidality occurring independent of any adverse event, and 13 that was true across the treatment arms. There were three 14 treatment arms: fluoxetine, placebo and tricyclic 15 antidepressant. 16 Q. And is there any conclusion one can draw from 17 the study? 18 A. Our conclusion was that there was no evidence 19 based on that data that there was an association -- 20 higher-than-chance association between experiencing any one of 21 those adverse events in the nine clusters and the emergence of 22 suicidality or a suicide act. 23 MR. McGOLDRICK: Judge, that's what I'm going to 24 do. 25 JUDGE POTTER: Ms. Zettler, is there any short 30 1 question you want to ask him before I rule on it? 2 3 AVOWAL_EXAMINATION ______ ___________ 4 5 BY_MS._ZETTLER: __ ___ _______ 6 Q. How many double-blind controlled studies have 7 been conducted on fluoxetine and depression? Over 100? 8 A. I don't know the exact number. 9 Q. Can you give me an estimate? 10 A. Double-blind placebo-controlled? 11 Q. Double-blind controlled studies. 12 A. Of any type? Oh, I'm sure that it would be 75 13 to 100, I would think. 14 Q. Okay. Is that United States and outside United 15 States? 16 A. Yes, it is. 17 Q. We've heard testimony that there were over 200 18 double-blind controlled studies done on depression. Would 19 that surprise you? 20 A. No. No. 21 Q. When you testified at your deposition, did you 22 have a copy of this article with you? 23 A. I don't believe so. 24 Q. At the time you were not sure of all the details 25 that you're sure of now about the study. Have you reviewed 31 1 the study since your deposition? 2 A. I've looked at it on several occasions. 3 Q. When was the most recent time you've looked at 4 it, Doctor? 5 A. Yesterday. 6 Q. And when did Lilly lawyers inform you that you 7 would be testifying about this study here at this trial? 8 A. I believe the issue came up yesterday in the 9 courtroom. 10 Q. So you didn't look at the study -- the most 11 recent time you've looked at the study was yesterday? 12 A. Yes. 13 Q. At your deposition we asked you a series of 14 questions if you expected to testify at this trial; do you 15 recall that? 16 A. Yes. 17 Q. And at the time you said you hadn't heard 18 anything about testifying at this trial; correct? 19 A. Correct. 20 Q. When were you told you were going to be 21 testifying at this trial? 22 A. Three or four weeks ago. 23 MS. ZETTLER: Judge, we got very little detail 24 on this study. 25 JUDGE POTTER: Is there any other part of this 32 1 you want me to read other than what Mr. Myers has given me? 2 MS. ZETTLER: What did he give you, on 158? 3 JUDGE POTTER: I assume it's a different study 4 you're talking about before 158; is that right? 5 MS. ZETTLER: Uh-huh. Yes. No, Your Honor. 6 JUDGE POTTER: Let me see the study. (Reviews 7 document) Doctor, I assume that even though it's not written 8 in your conclusion, one of the things you found is that 9 patients may experience a state of activation while receiving 10 fluoxetine as an adverse event, that it typically occurs early 11 in the course of events and that it tends to wane over time 12 and that there's a modest dose response relationship? 13 DOCTOR TOLLEFSON: That, Your Honor, has been 14 reported in some other manuscripts, but that would be 15 consistent, certainly, with the data set here. 16 JUDGE POTTER: But it's not set out in this 17 article? 18 DOCTOR TOLLEFSON: That is correct. 19 JUDGE POTTER: Does anybody else have anything 20 they want to say before I rule on this? 21 MS. ZETTLER: I'd just like to add, Judge, 22 again, if it goes to your rulings about any opinions that are 23 going to be rendered at trial by these current Lilly 24 employees, experts now, we touched on the study. He knew very 25 little about it that he could recall. We didn't have a 33 1 document to refresh his recollection with because, contrary to 2 what Mr. Myers has said, neither of these manuscripts were 3 produced to us before. I've never seen these manuscripts 4 before. Okay? I've seen other meta analyses of the same data 5 but not in this form. I've seen Doctor Beasley's meta 6 analysis strictly on suicidality. If they wanted to bring 7 this out at trial, they should have raised that issue during 8 the deposition so we would have had an opportunity to 9 thoroughly question him about it. 10 JUDGE POTTER: Let me ask you one thing, Doctor. 11 What were you referring to in that answer? 12 DOCTOR TOLLEFSON: This would be referring to 13 one of the papers authored by Doctor Charles Beasley on 14 activation and sedation as adverse events. 15 JUDGE POTTER: And not this study? 16 DOCTOR TOLLEFSON: Correct. 17 JUDGE POTTER: Mr. Myers, if I'm reading this 18 correctly, the only place this is discussed during Doctor 19 Tollefson's deposition is 158, Line 8, through 160, Line 4. 20 Is it discussed anywhere else? 21 MR. MYERS: No, sir. As to that article, the 22 subject matter of activation is what follows. 23 JUDGE POTTER: And he's testified about that 24 already; right? 25 MS. ZETTLER: Yes, Your Honor. 34 1 MR. McGOLDRICK: He's testified about 2 activation. I don't remember which particular part has been 3 referred to. 4 MR. MYERS: Yes, sir. This testimony from his 5 deposition comes from a discussion about activation and 6 sedation. 7 JUDGE POTTER: Uh-huh. Well, what do you say, 8 Ms. Zettler? You asked him about an article, he tells you 9 it's published around the first of '94, you say what does it 10 say; he gives you the bottom line. 11 MS. ZETTLER: Well, Judge, I mean, another thing 12 I'd like to point out is this Court ordered that the parties, 13 before this trial starts, produce documents they're going to 14 be using at trial, and this document -- I mean, they've 15 literally produced us, as far as Lilly documents are 16 concerned, Judge, the two-volume BGA report, that stack of 17 stuff that they submitted to the PDAC and, like, three other 18 pieces of paper with regards to this drug. I specifically 19 asked Mr. Myers is this all you're going to use, and he said 20 yes. Now, throughout this trial, through these witnesses 21 we've been getting new documents and new documents and new 22 documents. 23 I mean, our position is is that if he was going 24 to testify to this under your previous order, they should have 25 alerted us during the deposition so we had an opportunity to 35 1 cross-examine him specifically about it. They should have 2 produced that document to us then. This document, it appears, 3 was in existence at the time of his deposition; they should 4 have produced this to us then, too. We did not have an 5 opportunity, we had no reason to believe that they were going 6 to rely on this document in any way in this trial. 7 This man had very little knowledge without 8 refreshing his recollection at the time of his deposition. He 9 just testified that he wasn't even told till three weeks ago 10 that he was going to be testifying here and didn't even look 11 again at this article until yesterday after we raised this 12 issue. 13 JUDGE POTTER: I think you misunderstood his 14 testimony. He said the last time he looked at it was 15 yesterday. 16 I assume three weeks ago you began looking at 17 this article; is that right, sir, or close to three weeks? 18 You tell me when you started refreshing. 19 MR. McGOLDRICK: Have you looked at the article 20 a number of times? 21 DOCTOR TOLLEFSON: I have looked at the article 22 a number of times, yes. 23 MS. ZETTLER: Did you look at the article in 24 preparation for your deposition, Doctor Tollefson? 25 DOCTOR TOLLEFSON: No, I had not. 36 1 MS. ZETTLER: Why not? 2 DOCTOR TOLLEFSON: I had not looked at anything. 3 JUDGE POTTER: We're through with the 4 examination. Okay. I'm going to sustain the objection to 5 allowing him to testify about the study that's reflected in an 6 article that was published in Volume 14, No. 3, at 163 of the 7 Journal of Clinical Psychology. 8 Mr. McGoldrick, as far as an avowal goes, is 9 there anything else you want to get on the record? I will 10 treat his brief testimony here as an avowal of what he would 11 testify to at trial. Do you want to expand it in any way for 12 the record? 13 MR. McGOLDRICK: Well, let me just ask one or 14 two more questions, Doctor. In having done this study, do 15 you -- can you tell the jury whether this study gives help in 16 determining whether any adverse-event clusters, be they 17 agitation, be they insomnia, drowsiness, anxiety, 18 nervousness-type clusters, any of these clusters are related 19 to suicidality? 20 DOCTOR TOLLEFSON: Our conclusion was that this 21 particular article helped suggest there was no relationship 22 between suicidality or any of those specific adverse-event 23 clusters. 24 MR. McGOLDRICK: I think that's all, Judge. 25 JUDGE POTTER: Okay. We'll mark this and enter 37 1 it as Avowal Exhibit No. 421. 2 MR. MYERS: Judge, may I move also to mark the 3 other documents and excerpts as avowal exhibits, and I'll give 4 those documents to Ms. McBride? 5 JUDGE POTTER: I tell you what. We'll mark them 6 421A and 421B, April 7th and April 24th, and they'll be 7 admitted. And why don't you put little stickers on them. 8 MR. MYERS: I'd also like to offer that portion 9 of Doctor Beasley's testimony and Doctor Tollefson's 10 testimony. 11 JUDGE POTTER: All right. 421C and 421D. And 12 if you'll put the stamps on and give them to me, then I can 13 keep them up there, and that way they won't get involved. 14 MR. MYERS: Yes, sir. Thank you. 15 MS. ZETTLER: Thanks, Judge. 16 (HEARING IN CHAMBERS CONCLUDED; THE FOLLOWING 17 PROCEEDINGS OCCURRED IN OPEN COURT) 18 SHERIFF CECIL: All rise. The Honorable Judge 19 John Potter is now presiding. The jury is now entering. All 20 jurors are present. Court is back in session. 21 JUDGE POTTER: Please be seated. 22 Ladies and gentlemen of the jury, did anybody 23 have any difficulty observing my admonition? 24 How about you, Ms. Williams? 25 JUROR WILLIAMS: No, sir. 38 1 JUDGE POTTER: I'm sorry we got a late start 2 this morning. You-all don't know this because this is 3 probably your first trial, or certainly the first one of this 4 length, but the lawyers have done a pretty good job of getting 5 their disagreements resolved at night or early in the morning. 6 I think if you-all were sitting over on the other side in 7 another trial you would find that there would be a lot more 8 recesses to get things sort of thrashed out. I don't want to 9 jinx anything by saying how good they've been doing, but 10 they've been in here at 7:30 in the morning and working on it 11 at night and things like that to get it done where it doesn't 12 disturb your-all's cycle. 13 And one reason that's been done, you know, an 14 hour's delay in the middle of the day in a two-day trial 15 doesn't add up to that much, but you take an hour and a half 16 or a two-hour delay in the middle of a long trial and it adds 17 up to a lot at the end, so everybody has tried to make a 18 special effort to get things resolved. And I know you're 19 thinking why don't they do it weeks or months ahead. And I 20 think you realize a trial kind of unfolds and people try to 21 anticipate what's going to happen and what people are going to 22 say and what issues are going to come up, but even with all 23 the work they've done there are still surprises. 24 Doctor, I'll remind you you're still under oath. 25 Mr. McGoldrick. 39 1 MR. McGOLDRICK: Thank you, Your Honor. 2 3 EXAMINATION ___________ 4 5 BY_MR._TOLLEFSON: __ ___ _________ 6 Q. Good morning, Doctor Tollefson. 7 A. Good morning. 8 Q. I'd like to turn -- if Your Honor, please, 9 before we begin, I don't know whether there's any possibility 10 of doing anything with the heat. 11 JUDGE POTTER: You want it up or down? 12 MR. McGOLDRICK: I think it's pretty cold. No? 13 You like it? All right. Whatever you folks want. Very well. 14 That's all better. 15 All right. Let's turn to another subject, 16 Doctor Tollefson. Did there come a time when a question of a 17 possible relationship between Prozac and suicidal thinking was 18 put as a hypothesis? 19 A. Yes, there did. 20 Q. And approximately when was that? 21 A. February of 1990. 22 Q. And was that by way of a case report? 23 A. Yes, it was. 24 Q. Now, tell the jury what a case report is. 25 A. A case report is a published observation of some 40 1 event or circumstance that occurs while the physician is 2 treating a patient, that he or she feels is worth sharing with 3 their colleagues, and typically a case-report form at its best 4 will generate we call a hypothesis or a question that then 5 might be investigated further in controlled clinical trials. 6 Q. And so there were case reports in 1990 that 7 generated a hypothesis? 8 A. That is correct. 9 Q. And just the difference between a case report 10 and a controlled clinical trial? 11 A. Well, there are several. A case report is 12 uncontrolled, that is, that whatever is being observed is 13 subject to many, many different variables and many different 14 interpretations. It's done -- a case report typically would 15 describe one patient or a handful of patients, whereas a 16 controlled clinical trial would typically be done in very 17 large numbers of patients, and the controlled description is 18 that you are trying then in a controlled trial to minimize the 19 impact of all these many, many variables and focus down on 20 just one that is the subject of the study. 21 Q. Would it be an apt illustration, Doctor, a case 22 report, that if I had a cold and I took some medicine for the 23 cold and then later I got pneumonia, a hypothesis could be 24 either that the medicine I took caused the pneumonia or the 25 cold caused the pneumonia? 41 1 A. That's true. 2 Q. And a case report might report on this event 3 when I had my cold and that would generate these hypotheses 4 that you have to look at? 5 MS. ZETTLER: Your Honor, we're going to object 6 to the continuing leading nature of the questions. 7 JUDGE POTTER: It's sort of preliminary, but it 8 is leading. Go ahead, Mr. McGoldrick. 9 A. Yes. That's a correct analogy. 10 Q. All right. Now, when there was a case report or 11 case reports in '90, about hypotheses between Prozac -- strike 12 that. 13 Once again, is suicidality part of depression? 14 A. It is one of the nine symptoms of major 15 depression. 16 Q. All right. Now, when there were case reports in 17 1990, what did Lilly do? 18 A. Lilly, to my understanding, convened a panel of 19 consultants to advise them both on their analysis of the case 20 reports and also to make recommendations about in what ways 21 Lilly might look at their vast database to try to test this 22 hypothesis. 23 Q. And were you one of those consultants? 24 A. Yes, I was. 25 Q. And were there others? 42 1 A. There were two others, Doctor Jan Fawcett from 2 Rush Presbyterian Hospital in Chicago, Doctor George Winniker 3 was chairperson at the time at the University of Iowa 4 Hospital. 5 Q. And at this time you were still in Minneapolis? 6 A. St. Paul Ramsey Medical Center. 7 Q. Excuse me. St. Paul. Doctor, what is it that 8 Lilly asked these consultants, you and the others, to do? 9 A. Again, it was to look at those case reports and 10 offer opinions about the hypothesis that had been generated in 11 those observations and then to review what was in the Lilly 12 database and make suggestions how that database could be used, 13 what kinds of analyses could be conducted to try to test that 14 hypothesis. 15 Q. Now, did you have any impression at that time as 16 to whether Lilly was trying to downplay or cover up this data 17 or this question? 18 A. On the contrary. When we were there, there 19 seemed to be a significant amount of interest and a sincere 20 interest to try to get to the bottom of whether or not these 21 case-report observations and the interpretations were valid or 22 not valid. 23 Q. And did this group of experts and consultants 24 that were called in offer any suggestions to Lilly as to how 25 to go about doing it? 43 1 A. Yes, they did. 2 Q. What was that suggestion? 3 A. I think the principal suggestion was because in 4 these case reports what had been described were a small series 5 of very complicated patients who before starting treatment did 6 not have active or serious suicidal ideation, but during the 7 course of their receiving therapy and treatment they had an 8 emergence of fairly intense thoughts of suicide. So to test 9 that observation, the -- I think the primary recommendation 10 that we as a consulting group made was that given Lilly had 11 controlled clinical trial data on over 3,000 patients who had 12 participated in their United States studies of depression, 13 that one way to try to address whether or not this emergence 14 of suicidality occurred more often with Prozac or with other 15 antidepressants versus a placebo or a sugar pill, was to go 16 back to that Hamilton Depression Rating Scale, the Item 3 that 17 was discussed yesterday in the Court, and to ask the following 18 question: How many patients in that database in excess of 19 3,000 patients when they entered the study before they began 20 any treatment or the placebo, had a score on the Item 3 of 21 zero, which would be an absence, no suicidal thinking, or a 22 score of one, which would be only some passive thoughts about 23 life not being worth living, who then at any time during the 24 study, whether they were on fluoxetine, a tricyclic 25 antidepressant or a placebo had an emergence or an increase to 44 1 a score of three or four; three would be indicative of serious 2 ideation or thoughts of suicide, a score of four would be 3 suggestive that a suicidal act had occurred. So to summarize 4 that, changes from a zero or a one score before beginning the 5 study to score the maximum three or four on that item at any 6 time during the course of the study, we defined that for Lilly 7 as the emergence of serious suicidal ideation during 8 treatment. 9 Q. So you experts made that suggestion to Lilly. 10 Did Lilly follow it? 11 A. Yes, they did. 12 Q. And they went back and they looked at all of 13 that data? 14 A. That is correct. 15 Q. Was that an undertaking that took some effort? 16 A. A very, very significant amount of effort and a 17 lot of person hours. 18 Q. Now, you talked about how you suggested to Lilly 19 that they look at the HAMD scores and see if they went up in a 20 significant way in the one instance and whether they went down 21 and just sort of check that out in this clinical controlled 22 trial, and that's that same HAMD-3 item that we showed up here 23 on the board yesterday with zero to four? 24 A. Yes, sir. 25 Q. All right. Now, Lilly did go ahead and do this. 45 1 Are you familiar with the results of that work and that study? 2 A. Yes, I am. 3 Q. All right. And did you and then Lilly look at 4 the data in lots of different ways? 5 A. Yes. There were several different analyses that 6 were done. 7 Q. And did all of the looks -- all of the looks 8 that you took at that information give you cause for concern 9 or comfort with respect to Prozac and suicidality? 10 A. Our considered medical opinion was that the data 11 was reassuring that there was no evidence of a relationship 12 between any of the antidepressants, including fluoxetine, or 13 Prozac, and the induction or worsening of suicidality. 14 Q. All right. Now, let's take a look at at least 15 some of that. You looked at the U.S. clinical trial group, 16 all those clinical trials? 17 A. Yes. 18 Q. Let me see if I can get this out. All right, 19 Doctor. Now, in looking at the U.S. clinical trials, I'd like 20 just to take -- go through these categories. One thing I 21 think you said that you looked at was to see measured by this 22 HAMD whether there was worsening of suicidality; is that 23 right, sir? 24 A. That was one of three analyses that were 25 conducted on that data. 46 1 Q. All right. Let's get the others. And, again, 2 just on this one you're looking at HAMD scores and how they go 3 up or down; is that right? 4 A. In that case, worsening, it would be any 5 increase in score at any time during the clinical study. 6 Q. Even by one number? 7 A. Even by one point; that is correct. 8 Q. All right. And then you also looked at any -- 9 did you say any worsening of suicidality there? 10 A. Any is correct. 11 Q. And then you looked at any improvement of 12 suicidality; is that right? 13 A. That is correct. And that was defined as 14 looking at the patient's score on entry to the study before 15 receiving treatment or placebo and then looking at their last 16 visit in this study. So we will call that or often call that 17 a baseline-to-end-point change; end point being the time when 18 the patient had their last visit to the study. 19 Q. Okay. And then I think your testimony just was 20 that you looked at a third category, which you called 21 substantial emergence of suicide; is that right? 22 A. Emergence of substantial suicidal ideation. 23 Q. All right. Let me try to get -- that's a 24 mouthful. Let me see if I can get that. Substantial suicidal 25 ideation. All right. I think you'd better tell us one more 47 1 time what that is. 2 A. The emergence of substantial suicidal ideation 3 was an analysis of any patient before starting the study who 4 had an Item 3 Hamilton score, the suicide item, a score of 5 zero, absence of any thoughts whatsoever or a score of one, 6 which just were some passive reflections that life may not be 7 worth living, and then at any time during the clinical trial 8 had a score of three, significant suicidal thinking, or four, 9 a suicide act. 10 Q. So if you only went -- if you started at zero 11 and you only went up to one, that wouldn't get counted here? 12 MS. ZETTLER: Your Honor, we're going to object 13 to the continued leading nature of Mr. McGoldrick's questions. 14 Q. I'll rephrase that. If you started at zero or 15 one and went to two, would that be counted? 16 A. That would be counted as a worsening but it 17 would not be counted as an emergence of substantial suicidal 18 ideation. 19 Q. So you would capture it here but not here? 20 A. That is correct, sir. 21 Q. Here you were looking for the more significant 22 increases? 23 A. That's correct. Dramatic changes. 24 Q. And you compared Prozac and placebo? 25 A. Yes. 48 1 Q. And what was the third? 2 A. A group of tricyclic antidepressants or TCAs. 3 Q. Is it other antidepressants; is that a fair way 4 to say it? 5 A. Yes, that would be. 6 Q. All right. Now, Doctor, I asked you and you may 7 refer to the notes or paper, what were the results? Let's 8 first talk about worsening of suicidality, any worsening. On 9 Prozac what percent? 10 A. 15.3. 11 Q. And what about placebo? 12 A. 17.9. 13 Q. And what about the other medicines? 14 A. 16.3 percent. 15 Q. Now, Prozac looks like the best number there. 16 Are those statistically significant differences? 17 A. No, they are not. 18 Q. So they really look like -- to the statistician 19 and the scientist they're the same even though there's a 20 slight difference in the numbers in favor of Prozac? 21 A. They are comparable. 22 Q. All right. Now let's look at any improvement of 23 suicidality. What were the numbers there, first, with respect 24 to Prozac? 25 A. 72.2 percent. 49 1 Q. And placebo? 2 A. 54.8 percent. 3 Q. And other antidepressants? 4 A. 69.8 percent. 5 Q. All right. Now, are those the same -- those 6 numbers do look different. Are they different as we look at 7 statistical significance? 8 A. There's a statistically significant difference 9 between Prozac and placebo, that difference favoring Prozac, 10 that there were significantly more patients who had an 11 improvement from their baseline score than were seen with the 12 sugar pill or the placebo. Now, the comparison of Prozac with 13 other antidepressants was not statistically significantly 14 different. 15 Q. So the Prozac and the other medicines seemed to 16 do about the same in making suicidality better? 17 A. In improving suicidality. 18 Q. Right. And Prozac was better than placebo in 19 that respect? 20 A. It was statistically significantly better than 21 placebo in that trial. 22 Q. Not just the number, but it was statistically 23 significant? 24 A. Yes, it was. 25 Q. All right. Now, let's look at this last 50 1 category, emergence of substantial suicidal ideation. How did 2 those numbers come out, Doctor? 3 A. The fluoxetine number was 1.2 percent; 2.6 4 percent for placebo; and 3.6 percent for the other 5 antidepressants. 6 Q. And are those all about the same? 7 A. No, they were not. In fact, there were 8 statistically significant differences first of all between 9 Prozac and placebo, where there were less cases of this 10 emergence occurring with Prozac than were seen with the sugar 11 pill, or placebo, fewer cases. And then the comparison 12 between Prozac and other antidepressants in this analysis was 13 also statistically significant, again favoring Prozac in the 14 sense there were fewer -- significantly fewer emergences of 15 this zero-one to three-four change in the suicide item scale 16 from the Hamilton, fewer instances with Prozac than were seen 17 with the other antidepressants. 18 Q. All right. So there was this hypothesis that 19 Prozac might be related to suicidality or substantial increase 20 in suicidality and that was looked at? 21 A. Yes. 22 Q. It was looked at in the data from the clinical 23 trials? 24 A. Yes, it was. 25 Q. These were the results? 51 1 A. Yes, sir. 2 Q. And what's a fair conclusion from those results? 3 A. I would summarize it with three conclusions, 4 that between the three possible treatments in this group of 5 over 3,000 patients, Prozac, placebo or other antidepressants, 6 first of all, there was no significant difference regarding 7 worsening of suicide items or suicidality, which would be 8 consistent with that as a feature of the disease, which can 9 wax or wane, depending on the severity of the depression; that 10 when one looks at improvement of suicidality, not surprisingly 11 because suicidality is a symptom of this serious disease, 12 those patients that were receiving an active treatment, for 13 example, in this case Prozac, were statistically significantly 14 more likely to have a reduction, an improvement in suicidal 15 ideation as part of their recovery from the disease 16 depression. 17 The third conclusion would be regarding this 18 hypothesis, this observation, in case reports, that a very 19 small number of patients might during the course of treatment 20 have this emergence of serious suicidal thinking. The 21 conclusion is essentially twofold; one is yes, it happens, but 22 it happens as part of the disease because it's seen more often 23 with placebo or a sugar pill than it was seen with Prozac. In 24 fact, one could argue one possible interpretation of that data 25 would be that it would appear that Prozac may have had a 52 1 protective effect against the emergence of serious suicidal 2 ideation because the figures were significantly lower than 3 that seen with the placebo or the sugar pill. 4 Q. Regardless of whether it's protective or not, 5 this data goes a long way to show that the phenomenon of 6 Prozac being causally related to suicidality isn't so? 7 A. That's true. 8 Q. Doctor, in looking at this, is it surprising to 9 see suicidality in depressed patients? 10 A. Not at all. 11 Q. It's part of the disease? 12 A. It is. 13 Q. And as you look at this data and all evidence, 14 for that matter, is it fair to say either that suicidality is 15 part of the disease or part of something to do with the 16 medicine? 17 A. This data I think clearly states that changes or 18 worsenings, to be specific, in suicidality, would appear to be 19 part of the natural history in some patients of this disease. 20 Q. Now, Doctor, were the results, all the results 21 of these studies that you've shown us here, published? 22 A. Yes, they were. 23 Q. They're published in the peer-reviewed medical 24 literature? 25 A. Yes, it was. 53 1 Q. And made available to other scientists to look 2 at? 3 A. Yes, sir. 4 Q. Were these data made available to the FDA? 5 A. Yes, they were. 6 Q. Were they made available to the PDAC, the 7 advisory committee of the FDA? 8 A. Yes. They were made available to the PDAC. 9 Q. All right. Doctor, let's turn now to the PDAC. 10 The jury has already heard a lot about everything, but they've 11 heard a lot about the PDAC. I don't want to go through it in 12 great detail, but what is the psychopharmacology -- what is 13 the PDAC, first of all? What's it stand for? I may have even 14 forgot. 15 A. It's the Psychiatric Drugs Advisory Committee. 16 Q. All right. And that's a group of experts -- to 17 do this quickly, that's a group of experts called in by the 18 FDA to advise the FDA about questions that the FDA wants to 19 know the answer to? 20 MS. ZETTLER: Your Honor, again, Mr. McGoldrick 21 doesn't need to testify; it's Doctor Tollefson's testimony. 22 JUDGE POTTER: He's trying to speed us along. 23 MR. McGOLDRICK: I can take Doctor Tollefson 24 through ten minutes of that if Ms. Zettler wants. 25 JUDGE POTTER: He's trying to speed things up. 54 1 Go ahead, Mr. McGoldrick. 2 Q. PDAC is a group of experts called in by the FDA 3 to advise the FDA about questions that it wants advice from; 4 is that right, sir? 5 A. That is correct. 6 Q. And do these experts come from throughout the 7 country? 8 A. They come from throughout the United States and 9 sometimes there may well be invited consultants from 10 international medical communities. 11 Q. And you're familiar with that advisory committee 12 process? 13 A. Yes, sir. 14 Q. How many times did the advisory committee meet, 15 as we sit here today, to consider Prozac? 16 A. The advisory committee has met and deliberated 17 about Prozac on four separate occasions. 18 MS. ZETTLER: Your Honor, may we be heard on 19 this? 20 (BENCH DISCUSSION) 21 MS. ZETTLER: He's going to go into other 22 indications now, Judge. And as this Court well knows, we were 23 only allowed safety information on other indications. Whether 24 or not the FDA determined that it was safe and effective for 25 use in bulimia or OCD is not relevant to this case. What's 55 1 relevant to this case is depression. These other two meetings 2 came well after the '91 advisory committee meeting, one just 3 yesterday, as a matter of fact, and just doesn't have any 4 relevance in this case. 5 MR. McGOLDRICK: My response, Your Honor, is 6 that the Plaintiffs have put in issue violence and suicidality 7 on this medicine. The issue of violence and suicidality and 8 safety in general were considered in all four. Violence and 9 suicidality were considered in the last three, 1991, 1993 and 10 1994. The safety was considered in all of them and 11 suicidality to some degree in the '85 one, and so that issue 12 is considered in all of them. I do not propose to go into 13 efficacy on any other subject. I agree that would be beyond 14 the scope. 15 MS. ZETTLER: He's trying to get this four-time 16 stamp of approval. Mr. Myers and Lilly lawyers have argued at 17 length that the issue of OCD and bulimia are not relevant 18 because there is no connective disease process here. There is 19 no evidence that Mr. Wesbecker suffered from bulimia or OCD in 20 this case, so either one of those are completely irrelevant. 21 JUDGE POTTER: I was expecting the answer to be 22 it -- what is going to be the testimony about the other two? 23 MR. McGOLDRICK: There are two. I don't know 24 which two you're thinking about, '85 and '90. There's '85, 25 the original approval -- for the original approval. There's 56 1 '91 where they looked at violence and suicidality 2 specifically. There's '93 where we have OCD, obsessive- 3 compulsive disorder. In that hearing they did look at 4 violence and suicidality again. And then there's 1994, 5 bulimia, where they also looked at that subject again. That's 6 what the testimony will be. 7 MS. ZETTLER: We have not had access to the 8 transcripts of either the bulimia or OCD advisory committee 9 meetings. 10 JUDGE POTTER: Why not? 11 MS. ZETTLER: Because they haven't produced 12 them. They haven't produced them. It took us forever to get 13 the one from the '91 advisory committee on them. The point is 14 that he's just trying to get another stamp of approval on 15 here. We have no way of knowing if these issues were raised 16 or discussed or the basis or the data they used for anything. 17 JUDGE POTTER: Ms. Zettler, putting the 18 relevance of it aside, why do you think the discovery process 19 should preclude them in this process from at this point 20 bringing this issue up? 21 MS. ZETTLER: First of all, the bulimia one just 22 occurred yesterday or the day before, okay, I mean, the 23 advisory committee just met yesterday or the day before. 24 Well, I mean, the point is -- let me finish what I'm saying 25 first, please, the point is, is that neither of these 57 1 transcripts were produced. I mean, to put the onus on us to 2 go out and dig up these for trial is just prejudicial, Judge. 3 If they wanted to use these things at this trial -- we had a 4 huge hearing on this subject of whether or not these things 5 were relevant, you know, I mean to the discovery process. We 6 haven't had a chance to look at any of these studies because, 7 for example, the OCD studies were not allowed to use -- 8 JUDGE POTTER: Mr. McGoldrick, now that Ms. 9 Zettler reminds me, there was -- Mr. Myers I think will 10 confirm this, from your point of view there was sort of a 11 bright line drawn in documents you-all had to produce and, I 12 forget, bulimia and all the other things were kind of carved 13 out as not having to produce those that were used for that. 14 Am I right on that, Mr. Myers? 15 MR. MYERS: The exception is while the efficacy 16 data did not have to be produced the safety data including all 17 the adverse-event reports was and had to be produced, which 18 was the subject of the commissioner's review. So the Court is 19 correct on the efficacy part, but on the question of safety 20 that's not correct. 21 MS. ZETTLER: All they've produced to date, 22 Judge -- 23 JUDGE POTTER: Are the 1639s. 24 MS. ZETTLER: Mr. Myers is right. You did allow 25 us to look into the safety issues, but they mean nothing 58 1 without the study data. We've never seen these studies. 2 MR. McGOLDRICK: Just one corrected thing, I 3 think it's not to Your Honor's ruling. Ms. Zettler said that 4 the bulimia thing just occurred yesterday. That's not so. 5 I'm talking about the advisory committee meeting. That did 6 not occur just yesterday. 7 JUDGE POTTER: The approval came through 8 yesterday? 9 MR. McGOLDRICK: If she's right on that I don't 10 know. 11 MS. ZETTLER: It was Monday or Tuesday. 12 JUDGE POTTER: I'm going to sustain the 13 objection because I don't think that to get into -- I think 14 everybody agrees that the safety data dealing with the bulimia 15 thing is different from the safety data dealing with someone 16 who's depressed. Suicide is not a symptom of bulimia. 17 Suicide is not a symptom, and I just think we spend more time 18 arguing over the two that everybody agrees tangentially at 19 least relevance here and just focus on the two that -- 20 MR. McGOLDRICK: I accept Your Honor's ruling 21 except to say only that we do not agree that those have 22 tangential relevance, the question of whether the medicine 23 makes people suicidal. I'm not trying to be contentious. I 24 just don't agree when Your Honor says we all agree. I don't 25 agree to that. 59 1 JUDGE POTTER: Okay. 2 (BENCH DISCUSSION CONCLUDED) 3 Q. All right. Doctor, I would like you to focus on 4 two of the advisory committee meetings now, not any others. 5 The first one was -- do you remember which year, sir? 6 A. The very first one that I'm aware of was in 7 1985. 8 Q. Okay. And that was related to what? 9 A. The New Drug Approval for Prozac for the 10 indication of depression. 11 Q. And so the advisory committee, the experts were 12 then looking to see whether -- at the FDA's request whether 13 this medicine was safe and effective for use in depression? 14 A. That is correct. 15 Q. And what did they recommend to the FDA? 16 A. That Prozac was safe and effective in the 17 treatment of depression. 18 Q. Now, there was another PDAC meeting in what 19 year, sir? 20 A. There was another one in 1991. 21 Q. Okay. And we'll talk about that some more, but 22 what was the issue there? 23 A. The issue that the PDAC was addressing was 24 whether or not there was any credible evidence that 25 antidepressant medications caused suicidality or aggression, 60 1 violence. 2 Q. And they looked at antidepressant medicines in 3 general? 4 A. Yes, sir. 5 Q. Did they look at Prozac in particular? 6 A. Yes. 7 Q. And when they looked at these, what did they 8 conclude? 9 A. They concluded in a unanimous ten-to-zero vote 10 that there was no credible evidence that antidepressant drugs, 11 or Prozac specifically, were associated with induction of 12 suicidality or aggression and violence. 13 Q. Now, there's been some discussion here in this 14 courtroom, Doctor Tollefson, when you haven't been here, about 15 some charts that the FDA had at the time of that 1991 PDAC 16 meeting. I'd like to show you some of these charts that have 17 been shown around in this courtroom. This may be a little 18 difficult. Let me get this going. You have to be able to see 19 this a little bit, as well as the jury. I'll move this back a 20 little so we can see. And we'll see whether we need to move 21 it up or not. I'm referring to Exhibit 120 in this case and 22 I'm going to refer to some of the charts which have been shown 23 here by the Plaintiffs. And if I can do this right, can you 24 see that, Doctor? We'll get it focused, I hope. I better put 25 it this way. 61 1 All right. Do you remember charts of this sort 2 being the FDA having those in connection with the PDAC 3 meeting, sir? 4 A. Yes. 5 Q. All right. And this shows suicide attempts on 6 fluoxetine at fairly large number and smaller numbers on other 7 medicines; is that right? 8 A. Yes. 9 Q. And there were some other charts that have been 10 shown here. This is a similar chart showing hostility and 11 intentional injury events; is that right, sir? 12 A. Yes, sir. 13 Q. And there's still another chart that's been 14 shown here showing hostility and intentional injury on 15 fluoxetine? 16 A. Yes. 17 Q. And I'll show you one more here. This is one 18 that shows hostility and intentional injury on fluoxetine and 19 on trazodone. Can you see that all right? 20 A. Yes. 21 Q. All right. Now, I think there are big charts 22 like this over here that Mr. Smith occasionally has brought 23 out. Now, Doctor, these charts relate to what kind of 24 reporting system? 25 A. These related to what's called the spontaneous 62 1 event reporting system that is under the auspices of the Food 2 and Drug Administration. It's a spontaneous reporting system. 3 Q. All right. Tell the jury what a spontaneous 4 reporting system is. 5 A. Spontaneous reporting is a system that's in 6 place to encourage reporting of any observations that might 7 occur in a patient while they're receiving a medical therapy. 8 And those reports could come from physicians, other concerned 9 individuals, in fact, the vast majority typically come through 10 actually the manufacturers' reporting system. 11 Q. And were these reports or at least some of them 12 shown -- perhaps all of them shown by the FDA to this group of 13 experts at the 1991 PDAC meeting? 14 A. Yes, they were shown. 15 Q. And this group of experts had all of this 16 information in front of them? 17 A. That was part of what they reviewed in their 18 deliberations. 19 Q. They had a lot of information but they had 20 those -- 21 A. Yes, sir. 22 Q. -- before they made this decision? 23 A. Yes, sir. 24 Q. Now, when we take -- let's just take a look at 25 one of these charts that Mr. Smith has been showing around. 63 1 Let's take a look at this one. Now, it's a little hard and I 2 may have to move it up. Would you like it moved up? If I may 3 ask the jury that. 4 JUDGE POTTER: Mr. Smith will lend you his big 5 ones. 6 MS. ZETTLER: That's fine, go ahead. 7 MR. SMITH: You don't want my charts? 8 MR. McGOLDRICK: I may use those, Paul, but not 9 right now. Thank you. 10 MR. McGOLDRICK: Now, Doctor -- may I ask the 11 Witness to just stand here, Judge? 12 JUDGE POTTER: Yeah. He can walk around. 13 Q. Doctor, you can just stand here for this couple 14 of questions. Why don't you move back there so you're not in 15 the way of anybody. 16 MS. ZETTLER: It's Exhibit 120, John. 17 JUDGE POTTER: I tell you what, Doctor, why 18 don't you move down closer to the TV. 19 Q. All right. Doctor, now, we've got this chart 20 and this is one of the charts in Exhibit 120. Now, Doctor, 21 this chart appears to show more events in the fluoxetine group 22 than the trazodone group; is that right? 23 A. It shows approximately 20 events out of a 24 million prescriptions for fluoxetine and what looks to be 25 about one report out of a million prescriptions for trazodone. 64 1 MS. ZETTLER: Objection, Your Honor. That 2 mischaracterizes what the document says. It's per million. 3 Q. It reports per million prescriptions; is that 4 right? 5 A. I'm sorry. I thought that's what I said. 6 MS. ZETTLER: Okay. 7 JUDGE POTTER: I thought so, too. 8 Q. This is per million prescriptions, and it says 9 if I had a million quarters piled up here on this table there 10 would be 20 quarters in the fluoxetine group and whatever it 11 is, 1 or 2 in the trazodone group; is that right, sir? 12 A. Correct. 13 Q. Now, just stay there for a minute. We'll show 14 you another one quickly and then you'll be able to go back. 15 Let's take a look at one of the others. Let's take a look at 16 this one. It's again in Exhibit 120, one of those charts. 17 Now, that shows more events of suicidality and other events in 18 the fluoxetine group than in these other medicines? 19 A. Yes, sir. 20 Q. It shows a lot more as an absolute number; is 21 that right? 22 A. Yes. 23 Q. All right. You can go back to the stand, if 24 you'd like. 25 Now, here we see in these two charts and there, 65 1 are some others here, what look like a lot more absolute 2 numbers. Doesn't this give you some suggestion or 3 significance as to causation or what is the significance of 4 this as to causation? 5 A. Spontaneous event reporting systems can be used 6 to infer causality. In fact, an analogy that's given is that 7 spontaneous event reporting systems are only useful for 8 generating a hypothesis on causality when you're talking about 9 events that are rare and also distinctly different than part 10 of the disease. There's a well-known epidemiologist who has 11 worked in the area by the time of Feinstein that commonly 12 gives the example if you start on a medication and tomorrow 13 you have feathers coming out of your arm, that's a fairly rare 14 event, but, on the other token, the closer features are to the 15 disease in question or if those features are occurring less 16 frequently than the actual base rate of those circumstances in 17 our overall population, they really become quite meaningless 18 in trying to assume or infer a causality. 19 Q. Now, I don't necessarily want you to take a 20 whole morning or a whole day to give the jury a full course on 21 spontaneous reporting, but if you could, just give the jury a 22 sense of why one must be very cautious in looking at 23 spontaneous reporting numbers. 24 MS. ZETTLER: Your Honor, may we be heard on 25 this? 66 1 (BENCH DISCUSSION) 2 MS. ZETTLER: We can look it up on my computer, 3 if you'd like, Judge, but this man said not one word about 4 spontaneous reporting systems and rendered no opinions on how 5 it was to be handled and was never established as an expert in 6 regulatory compliance. In this area, he simply was not 7 disclosed. 8 MR. McGOLDRICK: He was at the meeting where the 9 FDA was talking about just these subjects. 10 MS. ZETTLER: That doesn't make any of them 11 experts, Judge. 12 JUDGE POTTER: Mr. McGoldrick, is he going to go 13 much beyond what we've already heard a dozen times or at least 14 several times of what a drug just starts out, et cetera, 15 et cetera? 16 MR. McGOLDRICK: He's going to answer this 17 question, Judge, in a narrative way listing a number of 18 factors as to why we have to be cautious and then I'm moving 19 on. 20 MS. ZETTLER: What he's going to say is things 21 like -- I'm assuming because I haven't heard him testify to 22 this before, but I'm going to guess it had something to do 23 with the numbers of adverse events. 24 MR. McGOLDRICK: I think he has pretty good 25 information about this. 67 1 MS. ZETTLER: Then let's get Doctor Talbott. 2 JUDGE POTTER: I'm going to overrule the 3 objection. We've listened to this before. I'm going to 4 overrule the objection. 5 (BENCH DISCUSSION CONCLUDED) 6 Q. All right, Doctor, not at any great length, tell 7 the jury what the factors are that make it such that we have 8 to be very cautious about implying any causation from such 9 spontaneous-event reporting numbers. 10 A. Well, there are very, very many reasons. One 11 that's often looked at initially is how often does the event 12 in question occur in general terms in the population. So, for 13 example, if one were talking about suicidality and at the time 14 these charts were shown there were approximately two million 15 patients receiving Prozac, it's known from data from the 16 National Institutes of Mental Health that the incidence of 17 suicide attempts in depressed patients, there are 18 approximately 3.5 percent of depressed patients who during the 19 course of one year might have a suicide attempt. So if you 20 then look at those 2 million people over the course of one 21 year, that 3.5 percent becomes 70,000 suicide attempts. 22 MS. ZETTLER: Your Honor, again, this Witness 23 has not been established as an expert to this subject matter. 24 He's going way beyond his testimony previously. 25 JUDGE POTTER: Objection is overruled. 68 1 A. So that the base rate according to data from the 2 federal government, the National Institutes of Mental Health, 3 would say that in a population of 2 million people with 4 depression over the course of one year you would expect as 5 part of the disease process 70,000 suicide attempts. Now, 6 when one looks at the number of spontaneous reports received, 7 you need to consider how often this occurs, suicide attempts, 8 relative to the number of reports, to determine whether or not 9 there's any possible sign there that would suggest it should 10 be further evaluated. 11 The same thing could be said as far as the base 12 rate of aggression or violence. Question would be how often 13 does one see aggression, for that matter, homicide in the 14 United States, a part of our society. Center for Disease 15 Control says about 8.6 homicides per 100,000 Americans per 16 year is the figure. Looking over then a million individuals, 17 a city of 1 million people, one might expect based on that CDC 18 information there would be 86 homicides that would occur in 19 that city of 1 million people in the course of one year. So 20 that's an important thing in establishing a base rate. 21 Then there are a whole number of other features 22 about this system that typically -- people that write about 23 spontaneous-event reporting and specifically the FDA's system 24 have commented on in the medical literature they include 25 changes in the system overall. In fact, since 1982 there has 69 1 been a tendency for all drugs to have more reports coming into 2 the FDA for any events. There is a well-known phenomenon 3 called the Weber phenomenon, which says essentially when a 4 drug is new in the marketplace there tends to be a peak in the 5 number of reports of side effects associated with that drug 6 and after two years the number of reports declines 7 dramatically. Somewhat analogous to if a new restaurant were 8 to open in the community, the first year people tend to talk 9 about the restaurant; did they like it, did they not like it. 10 It's a discussion point, a focal point. After the restaurant 11 has been open a year or two, typically the number of 12 discussions about it go down. That same type of phenomenon 13 has been described in the medical literature by a investigator 14 named Weber. 15 Another consideration that's been articulated is 16 the media or publicity. Because this is a spontaneous 17 reporting system, if your awareness to think about the 18 possibility of something is heightened because you've heard 19 about it recently, you're more likely to report it than if you 20 had not heard about it. So whether or not a compound or a 21 product, for example, is something that's been discussed and 22 you've heard about it recently, can influence how likely you 23 are to report or not report. 24 And there are a number of other things that go 25 on that list, including how long has the patient actually been 70 1 on the medication, how many days have they been exposed to the 2 medication, not just were they prescribed it or not. Looking 3 at number of days of exposure, that's quite important, the 4 type of patient receiving the medication. 5 For example, if someone thought that a certain 6 medication was really quite safe in a patient who otherwise 7 had a very serious disease, they might choose that medication 8 more often than another one that was less safe. What you 9 might see, though, is that if you're using that medication in 10 a very high risk group, while you follow their treatment, you 11 might see some of these observations occurring at a higher 12 frequency rate just because you're talking about more at-risk 13 patients receiving one drug than another drug. 14 Then there have been a number of other changes 15 in the system, the way, you know, event terms that have been 16 added or deleted over time, that certainly can influence what 17 these numbers might mean or how they could be interpreted. 18 Q. Taking these into account in connection with the 19 spontaneous reporting, did these numbers on these charts imply 20 causation? 21 A. They did not. 22 Q. All right. Let me just -- I guess I have to 23 turn this back on. 24 Let me call your attention to one thing you 25 talked about, and that is this thing I think you called the 71 1 Weber Effect after Doctor Weber who reported on it, and that 2 was that in the beginning a new medicine may have a lot of 3 reports but then over time they tend to go down for any new 4 medicine in spontaneous reporting. Do you recall testifying 5 about that, sir? 6 A. Yes, sir. 7 Q. All right. Let's take a look at this chart and 8 this shows spontaneous reports with respect to suicide 9 attempts, overdose and psychotic depression. Then we have a 10 chart that's been shown here showing spontaneous-event reports 11 comparing trazodone and Prozac with respect to hostility and 12 intentional injury. If what you said was true, that there was 13 in the first couple of years you see a lot of reports and then 14 according to Doctor Weber they tend to trail down, as with any 15 medicine, you'd expect to see this curve go up and then start 16 to come down; is that right? Can you see that? 17 A. Your Honor, may I step down? 18 JUDGE POTTER: Sure. 19 Q. If what you said was true about a -- an effect 20 of spontaneous reporting that in the beginning years of a 21 medicine you start to see it go up and then you later see it 22 come down, we should be seeing reports for Prozac coming down; 23 is that right, sir? 24 A. Yes. 25 Q. Have we in fact seen reports for Prozac coming 72 1 down? 2 A. The Spontaneous Reporting System that comes 3 through Lilly and goes to the FDA's system has indeed declined 4 over the last three years. 5 Q. And would it be down to levels as low as down 6 here? 7 A. That would be an approximation of where it would 8 be, yes. 9 Q. So it would be something along this order is the 10 way the chart would go? 11 A. It would be a curve. 12 Q. A curve down; is that right, sir? 13 A. Yes, sir. 14 Q. Now, by the way, what percent of spontaneous 15 reports come to the FDA from Eli Lilly, that is, Eli Lilly 16 actually sends them in? 17 A. According to the FDA, approximately 90 percent 18 of the spontaneous events that they receive have come through 19 Eli Lilly and Company with regard to Prozac. 20 Q. Thank you, Doctor, you may resume the stand. 21 Now, if the spontaneous reporting system is not a particularly 22 good way to look at causation, what is, scientifically? 23 A. The preferred scientific method is what we have 24 talked about earlier, a controlled clinical trial, and ideally 25 a controlled clinical trial that has at least one arm that has 73 1 a placebo or a no-active treatment component so that one can 2 determine again how frequently this event occurs as part of 3 the disease without the effect of a medication, and then that 4 allows for appropriate comparison of the incidents or the rate 5 of that event. 6 Q. And this is the kind of thing you did when you 7 looked at the -- these numbers, went back and looked at your 8 clinical database? 9 MS. ZETTLER: Objection. That's not what he 10 said. 11 JUDGE POTTER: Sustained. It's leading. 12 Q. Is that the kind of thing you did? 13 A. These numbers that you had written on the 14 graphic come from controlled clinical trials of patients with 15 depression in excess of 3,000 individuals, and as you had 16 delineated, some of them were receiving Prozac, some were 17 receiving other antidepressants, and very importantly there 18 was another group receiving a placebo or sugar pill, which as 19 I had indicated, allows the establishment of the base rate, 20 the incidence of that event without the impact of a drug. 21 Q. All right. And from your analyses of -- 22 Lilly's analyses of the data with respect to this subject and 23 controlled studies, is there any evidence that you discovered 24 that Prozac causes suicidality or violence or homicide? 25 A. Well, based on a number of the controlled 74 1 clinical trials that we have conducted, we find no credible 2 evidence that there is an association between Prozac and the 3 induction of suicidality or aggression. 4 Q. All right. Now, was all of this information and 5 a whole lot more presented to the PDAC experts in 1991? 6 A. Yes, it was. 7 Q. And was the FDA aware of those data and that 8 information? 9 A. They were. 10 Q. And I may need to get out the talk paper, 11 Exhibit 47, I believe. Bear with me one second. And what did 12 the PDAC conclude? 13 A. The PDAC took a vote and that vote was ten to 14 zero, it was a unanimous vote saying that there was no 15 credible evidence that antidepressants or specifically 16 fluoxetine were associated with suicidality or violence. 17 Q. All right. I'm going to show you Exhibit 173, 18 which has previously been in this trial, and ask you just what 19 type of document is it. 20 A. This type of document is referred to as a talk 21 paper. It's an official document that comes from the United 22 States government, specifically out of the United States 23 Department of Health and Human Services, the Food and Drug 24 Administration, and it is prepared by the FDA essentially to 25 disseminate or share information with the public. 75 1 Q. And, again, for the jury's reference, what is 2 the exhibit number at the bottom? 3 A. 173. 4 Q. All right. 5 Ms. Zettler, I'm going to ask the Witness a 6 question about this and show it as a demonstrative, if you'd 7 like to look at it first. 8 MS. ZETTLER: Judge, we haven't seen this before 9 but we have no objection since it's just a reiteration of what 10 Doctor Tollefson just said. 11 Q. Doctor Tollefson, I'd like to call your 12 attention to the third page, I think it is, and there is a 13 third paragraph which maybe I'll point out to you and maybe 14 we'll do it one more time. This paragraph -- maybe the jury 15 does have that -- and I'd ask you to read that as I put this 16 excerpt from it up here on the board. 17 A. This is the second paragraph on Page 3. "The 18 committee unanimously agreed that there is no credible 19 evidence of a causal link between the use of antidepressant 20 drugs, including Prozac, and suicidality or violent behavior. 21 Committee Chairman Daniel E. Casey, M.D., summarized the 22 committee's view by saying, quote, there was no evidence 23 showing an increase of suicidality with any of the drugs in 24 depressive or nondepressive patients, and regarding Prozac, we 25 probably have looked more closely and analytically at those 76 1 data than on any other antidepressant drug." End of quote. 2 Q. All right. Doctor, we won't go into any more of 3 that because the jury does have it. Let me ask you this: 4 Does Lilly continue as part of its constant monitoring to look 5 at aspects of this medicine and any other medicine with 6 respect to suicidality, violence and aggression? 7 A. Yes, they do, Mr. McGoldrick. 8 Q. And having kept up to date on that with the data 9 and the literature, what does it show? 10 A. It continues to confirm what I just read and the 11 deliberations of the PDAC, that there was no and there is no 12 credible evidence of a causal linkage between Prozac and 13 suicidality or violence. 14 Q. Thank you very much. 15 Cross-examine, Your Honor. 16 JUDGE POTTER: Okay. Ladies and gentlemen, 17 we'll take the morning recess at this time. Do not permit 18 anybody to talk with you or communicate with you about this 19 case. Do not discuss it among yourselves and do not form or 20 express opinions about it. We'll take a 15-minute recess. 21 (HEARING IN CHAMBERS) 22 JUDGE POTTER: Let's get down to this, because 23 Ms. Zettler has made a motion to be allowed to cross-examine 24 this Witness with the use of -- and I'm not going to 25 distinguish between the various ones but, in other words, ask 77 1 the question is it not true that Lilly has been convicted of a 2 misdemeanor for failing to produce, what was it, 1639s or 3 whatever? 4 MS. ZETTLER: Report numerous deaths in early 5 clinical trials. And, also, they've also -- I think the most 6 important point here, Judge, and I guess I don't even have to 7 get into whether or not they were convicted, but the fact is 8 in 1983 as well as just very recently this year, the FDA has 9 either changed regulations or have proposed changes in 10 regulations because of the conduct of Eli Lilly and the 11 reporting of adverse events. 12 JUDGE POTTER: You have a House report. First 13 of all, what we're talking about is a question -- because this 14 is cross-examination. 15 MS. ZETTLER: Right. 16 JUDGE POTTER: And I looked at the 1994 stuff or 17 whatever it is, 1994, and I can't find Lilly mentioned in 18 there anywhere. They may have changed the rules because of 19 that, but I read the talk paper and did not find Lilly 20 mentioned anywhere in the 1994 stuff. I haven't read the 21 House report, but I'm assuming that it legitimately indicates 22 that Lilly was found to not have reported -- is Oraflex and 23 the other thing the same drug? 24 MS. ZETTLER: No. Two different drugs. And I 25 think Mr. Freeman can probably confirm that FIAU is a Lilly 78 1 drug. 2 MR. BRENNER: It's not quite that simple. I'm 3 probably the only person, from my understanding, that knows 4 anything about that, and I don't know much. 5 JUDGE POTTER: Let's get down to it. Since this 6 thing first came up, I have kind of listened for this motion 7 and listened to testimony with this motion in mind. And 8 Doctor Greist, I thought I was going to get it then. If I'm 9 quoting him correctly, he said Lilly is in the forefront of 10 wanting to report everything when he was telling us why he -- 11 anyway, describing in response to a question. This Mr. 12 Tollefson has -- he was the Schweitzer fellow, talking about 13 why he wanted to go to Lilly, said that their reputation was 14 top notch. They asked him about when he was doing his 15 clinical trials was there any indication that Lilly suggested 16 that he downplay events or do anything, and he vehemently 17 denied that. 18 I think I understand Ms. Zettler's argument. 19 And, Mr. McGoldrick, in Kentucky, if you put in reputation one 20 way, you're allowed on cross-examination -- you know, my son's 21 the most honest person I ever knew, he wouldn't hurt a fly or 22 whatever it happens to be. Dear Ms. Jones, didn't you know 23 he's been convicted of, you know, assault and battery 12 times 24 and bad check 20 times or whatever it happens to be. And my 25 question is, sir, have you not opened this Witness up to the 79 1 question, Doctor, did you know, and presuming that she has a 2 factual basis, can accurately describe what happened in '84 or 3 '85 with this prior drug, when you said they were top notch, 4 were you aware of that. 5 MR. McGOLDRICK: Yes, Your Honor. Let me 6 respond to that. First, absolutely not. And the reason is 7 the man was simply asked what his reasons for coming were and 8 what his view of the reputation of Lilly was or the 9 scientists -- the quality of science there at the time. That 10 is in the nature of just qualifying the man, explaining why he 11 came. It's not putting the company in issue. Furthermore, 12 Your Honor, if in any case, and I suggest it would be 13 virtually every case in America where the company in a 14 products case or a negligence case is proving its own safety, 15 proving its characteristics of safe behavior, safe conduct, 16 has to face all other products and all other incidents, it's 17 going to make these trials completely unmanageable. We have 18 won Oraflex cases. They take a long time to try. They have 19 their own set of medical things about the company's conduct, 20 and to get into that kind of highly inflammatory sideshow on 21 this slender read, at best, I would suggest is a great error 22 and not consistent with the law of Kentucky. 23 So my first point is, I don't think I've put 24 reputation in issue by the questions I've talked about here, 25 and even if it were so, to be able to let that be an opening 80 1 to an entire discussion of the company's activities in any 2 respect at any time, I think is just wrong, Judge. 3 JUDGE POTTER: We're not talking about whether 4 Oraflex is a good drug or a bad drug. What we're talking 5 about is the simple question about whether Lilly was 6 reprimanded or whatever. We'd have to -- she'd have to 7 explain to me what the question is and show that there's a 8 factual basis for it; that Lilly has been criticized, 9 reprimanded, punished, whatever, in 1983, for failure to file 10 certain types of reports. You don't even have to mention 11 Oraflex, you don't have to mention anything else. But should 12 she not be allowed to do that? Because the Plaintiffs have 13 been beaten over the head with how thorough this system is. I 14 mean, we even heard today what percentage of the 1639s come 15 from Lilly, 90 percent. I mean, it's just been a constant 16 theme in this case that every bit of information gets to the 17 FDA on a timely, expeditious basis. 18 MR. McGOLDRICK: Judge, first, if I may, this is 19 so foreign to this case, as I see it at least, that I don't 20 even know -- personally I don't know about what the Oraflex 21 situation is except in general, and I think Mr. Myers does 22 know about that, and I don't know about FIAU because I just 23 don't know about that, Mr. Brenner does. And perhaps they can 24 address those specifics. I can tell you that on those, I 25 can't, because they're not part of this case and I don't 81 1 have -- 2 JUDGE POTTER: Ms. Zettler, what is the question 3 you're planning to ask? 4 MS. ZETTLER: If he is aware that in 1983 5 Lilly -- that the federal regulations were changed after 6 recommendations by a Senate/House subcommittee after 7 investigating Lilly's failure to report deaths on one of their 8 drugs that occurred on clinical trials on one of those drugs 9 and whether or not those drugs occurred outside the United 10 States. 11 You know, I'd also like to point out, Judge, 12 that Doctor Tollefson got up there two or three times and 13 talked about how Lilly has been complimented by the FDA on 14 their reporting system, how the FDA has said, without any 15 backup whatsoever, that it is the most elegant and sensitive 16 reporting system in the world and on and on and on and on and 17 on. 18 JUDGE POTTER: You mean Thompson? 19 MS. ZETTLER: Yes, I'm sorry. Thompson, in 20 nonresponsive answers to questions Mr. Smith asked him. And 21 every chance he got he got into 40 companies have come to look 22 at our reporting system and this, that, and the other thing. 23 And, you know, he's making them sound like the gods of 24 reporting, and it's just not true. This company has a history 25 of this kind of conduct and we've got documentation of that 82 1 history and we should be allowed to put it in. 2 MR. McGOLDRICK: That history is not relevant, 3 A, this witness did not testify about that. 4 JUDGE POTTER: Well, there is a cumulative 5 effect here. I mean, this Witness -- maybe if this was the 6 first witness that had said I went there because it's top 7 notch, I might be tempted to say that the confusion and 8 problems that would come out of this would outweigh whatever 9 probative value it might have, but I think in estimating its 10 probative value, I cannot only take into account what this 11 Witness said but I think I can take into account how his 12 testimony fits into a theme. And, I mean, I might be wrong 13 but I've got a quote, Lilly is in the forefront of wanting 14 everything reported, from Greist. And I don't know if this 15 stuff was brought up when Leigh Thompson testified or not, but 16 my memory would be -- 17 MR. BRENNER: Actually it was, Your Honor. At 18 that time you ruled he wouldn't be allowed to inquire about 19 it. 20 JUDGE POTTER: Right. I probably did. But as 21 things go along, the factors that I try and weigh change. 22 MR. McGOLDRICK: Judge, may I be heard? 23 JUDGE POTTER: Uh-huh. 24 MR. McGOLDRICK: Your Honor please, I think this 25 is a subject of major moment to this trial. Not only do we 83 1 respectfully think that it would be a grave, grave error to 2 admit this, but it is, we think, highly inflammatory and at 3 best, best, peripheral to the issues in this case. With that 4 in mind, before Your Honor permits any examination or any 5 evidence on this subject, I wonder if -- I don't know what the 6 schedule's going to be this morning and whether Ms. Zettler 7 plans to go through the noon hour, but I wonder if we could 8 have a more complete argument on this at the lunch hour. 9 MS. ZETTLER: Can you speak up, John? I can't 10 hear you. 11 MR. McGOLDRICK: I'm sorry. I apologize. I 12 wonder if we could have an opportunity to argue this at 13 greater length either at the noon hour or some appropriate 14 time, perhaps submit paper. We really think this is the kind 15 of thing that could be very destructive of the trial. I 16 haven't been here. I don't know whether there's error on 17 either side anywhere. 18 JUDGE POTTER: Oh, there's probably error on 19 both sides, the question is how much. 20 MR. McGOLDRICK: I understand. And what I'm 21 saying, Your Honor, with respect -- 22 JUDGE POTTER: I appreciate the fact that this 23 is a significant call. 24 MR. SMITH: May I say something, Your Honor? 25 JUDGE POTTER: (Shakes head negatively). 84 1 MR. SMITH: Okay. I won't say anything. I'm 2 sorry. 3 MS. ZETTLER: Let me make a couple of points 4 here. This is probably the last Lilly witness we're going to 5 see on the stand, and I can guarantee if you grant Mr. 6 McGoldrick's request, we aren't going to see any more Lilly 7 witnesses on the stand. I'm not sure if that's a blessing or 8 not. But the fact of the matter is that we have raised this 9 issue at least five times that I can think of, including this 10 time, and every time the Judge has -- the Court has said 11 basically I don't think there's enough there, I don't think 12 there's enough there. Every witness they put on the stand 13 that's even remotely related to this drug has said, "This 14 company is the gold standard of drug companies," and it's just 15 not the case. And we have a right to, as Your Honor himself 16 pointed out, to go after their reputation data or the 17 reputation evidence, and this is directly on point. Not only 18 does it show that they are not being honest when they say that 19 they're always reporting everything in the best way it can be 20 reported, it also shows that the FDA itself took steps related 21 to regulations in tightening up reporting requirements based 22 on Lilly's actions. 1983 was the same time that they were 23 getting ready to file the NDA on this drug. Doctor Ian 24 Shedden, who was the doctor who was involved in the Oraflex 25 deal, was involved in this drug. I mean, it's just 85 1 incomprehensible to me that this is not relevant to this 2 issue. 3 MR. McGOLDRICK: Your Honor please, I think it 4 is an entire side issue. It may cause us to have to bring in 5 a whole bunch of stuff about this. I think it just has the 6 potential to engulf this trial in -- 7 JUDGE POTTER: Well, that's one reason I ruled 8 in your favor previously was that I saw it as bringing in 9 another fairly major issue into the trial. But then 10 repeatedly they've been hit over the head with top notch, 11 wanting to report, I mean... 12 MR. McGOLDRICK: But, Judge, with respect to 13 Prozac that's the testimony we've been offering and we stand 14 by that. And if the Plaintiffs can attack that, that's fine. 15 Beyond that, if there has been even the slightest going beyond 16 that penumbra of that, it's the safety in connection with 17 Prozac, it has been, if at all, and I suggest it's not at all; 18 slight, if that. And that to take that little tiny bit and 19 cause this whole trial to start to get into this problem of 20 other products, the company's conduct in other entirely 21 unrelated products, strikes me, Your Honor, as being far 22 outweighing any probative value that could come from any 23 cross-examination question that would be permissible on this 24 subject. 25 JUDGE POTTER: Ms. Zettler, what is the question 86 1 you intend to ask? Take a minute and write it down so that I 2 know exactly what we're dealing with. 3 MS. ZETTLER: Judge, can I have a couple minutes 4 to confer with Mr. Smith? 5 JUDGE POTTER: Well, let me ask you this: Have 6 you got enough cross-examination to get us to lunch or is 7 this -- 8 MS. ZETTLER: May be close. I'd have at least 9 an hour with this guy but it could be shorter, I don't know. 10 MR. McGOLDRICK: We could break if they wanted. 11 JUDGE POTTER: All right. Let's go till -- 12 would it disrupt your planned cross-examination unduly if you 13 went -- took an hour and then we thrashed this thing out at 14 lunch, rather than me making a decision right now? 15 (HEARING IN CHAMBERS CONCLUDED; RECESS) 16 SHERIFF CECIL: The jury is now entering. All 17 jurors are present. Court is back in session. 18 JUDGE POTTER: Please be seated. 19 Doctor, I'll remind you you're still under oath. 20 Ms. Zettler. 21 22 EXAMINATION ___________ 23 24 BY_MS._ZETTLER: __ ___ _______ 25 Q. You testified earlier that the 1985 I believe 87 1 it's psychopharmacological drug advisory committee; is that 2 correct? 3 A. Yes, ma'am. 4 Q. Not psychiatric? 5 A. Psychopharmacological. 6 Q. That the 1985 PDAC committee ruled that the drug 7 was safe and effective; correct? 8 A. Correct. 9 Q. Were you at that meeting? 10 A. I was not there. 11 Q. You weren't working at Lilly at the time, were 12 you? 13 A. No, I was not. 14 Q. In fact, is it safe to say that you probably 15 hadn't heard of Prozac in 1985? 16 A. I had heard it discussed in the medical 17 literature as a research drug. 18 Q. You hadn't done any research on it? 19 A. I had not. 20 Q. And you hadn't used it in patients because it 21 hadn't been approved, so who told you that the drug was safe 22 and effective? 23 A. I can't say that anyone told me. It is standard 24 practice for the Food and Drug Administration when they review 25 a drug to evaluate it on both comprehensive safety and 88 1 efficacy for the indication. So by virtue of the fact that it 2 was approved for the treatment of depression, I would assume 3 that it was approved to be both safe and effective. 4 Q. But it's an assumption on your part that the 5 advisory committee in 1985 was called to make a judgment on 6 whether or not this drug was safe and effective? 7 A. Assumption based on the standard operating 8 procedures of that committee. 9 Q. Are you aware that not every new drug goes 10 through an advisory committee with the FDA? 11 A. Yes. 12 Q. And generally when that's done, the FDA 13 perceives a problem; correct? 14 A. That is not correct. 15 Q. There are numerous reasons but one would be if 16 it perceived a problem. 17 A. I would think that the reasons that they would 18 use the PDAC is when they need an expert consultant's opinion, 19 and there could be a whole range of opportunities where an 20 expert consulting opinion could be useful. 21 Q. Okay. So in that scenario, one reason could be 22 because they perceive a problem either with the proof of 23 efficacy or the proof of safety of the drug; correct? 24 A. That could be possible. 25 Q. Another reason is if it's a new type of 89 1 compound? 2 A. Yes. 3 Q. Okay. Judge, may I approach the Witness? 4 JUDGE POTTER: Uh-huh. 5 MR. McGOLDRICK: Excuse me, Your Honor. I think 6 we have to approach the bench. 7 (BENCH DISCUSSION) 8 MR. McGOLDRICK: This is a 1985 transcript from 9 the Psychopharmacological Drug Advisory Committee, Judge. 10 MR. MYERS: We've not been furnished with that 11 document it's not sworn evidence and there's been no 12 disclosure. 13 MS. ZETTLER: Judge, they have a copy of this. 14 MR. MYERS: Is it the '85 or the '91? May I see 15 the document? This one we have been supplied with, I stand 16 corrected. If she's going to try to impeach him, that's not 17 sworn evidence in there, if she's going to try to impeach him 18 with a transscript of a meeting. 19 JUDGE POTTER: What are you going to ask him 20 about it? 21 MS. ZETTLER: I'm just going to point out that 22 the reason the advisory committee was convened was not to make 23 a ruling on safety and efficacy; it was because they wanted to 24 get an analysis of the information that they had, and they 25 also wanted suggestions as to where they needed to go further 90 1 to establish the safety and efficacy of this drug for 2 approval. There's been testimony after testimony about this, 3 Judge. 4 MR. McGOLDRICK: I'm sure there's a lot of 5 testimony. 6 JUDGE POTTER: Why does what you've got in your 7 hand say that? 8 MS. ZETTLER: Why does it say that? "Again, 9 remember the subject for today of fluoxetine is not on the 10 approval of fluoxetine, per se. We are asking the Committee's 11 advice on whether or not the evidence that bears on safety and 12 efficacy is as we believe it is. There is still additional 13 safety information that must come in. There are questions 14 about the metabolism of fluoxetine, et cetera, et cetera." 15 Then they go on to say in here that they hadn't reviewed the 16 safety of the drug. 17 JUDGE POTTER: Does everybody agree that this is 18 an accurate transcript of the proceedings? 19 MR. MYERS: We have no reason to question that. 20 JUDGE POTTER: Objection is overruled. 21 MR. McGOLDRICK: Judge, just one point. With 22 respect to the question and answer that's just been talked 23 about that's one thing, but there may be much more in that 24 transcript that I don't know and I don't think there's an 25 offer been made about that. 91 1 JUDGE POTTER: You just have to object to it as 2 it goes along. 3 (BENCH DISCUSSION CONCLUDED) 4 Q. Okay. It's your belief that the 1985 PDAC -- 5 can we call it PDAC for short so we don't have to keep saying 6 Psychopharmacological Drug Advisory Committee? 7 A. That would be great. 8 Q. Okay. The PDAC was called to render a judgment 9 on whether the drug was safe and effective, the drug meaning 10 Prozac; correct? 11 A. Yes. 12 Q. And, again, you were not at that meeting? 13 A. I was not there, no. 14 Q. I'm showing you, Doctor Tollefson, a copy of the 15 transcript from the 1985 PDAC meeting. Okay. During this 16 meeting I believe it's Doctor Leber stated at Page 25, 17 starting at Line 19: "Before I turn the discussion over to 18 our staff, I would like to make a couple of observations. 19 Again, remember the subject for today of fluoxetine is not on 20 the approval of fluoxetine, per se. We are asking the 21 Committee's advice on whether or not the evidence that bears 22 on safety and efficacy is as we believe it is. There is still 23 additional safety information that must come in. There are 24 questions about the metabolism of fluoxetine, its apparent 25 nonlinear pharmacokinetics, the possibility that blood levels 92 1 of fluoxetine and its long-acting metabolites may be 2 accumulated. These have yet to be decided, but I believe they 3 are labeling issues and will require further review." 4 Correct? 5 A. Yes. 6 Q. Now, it goes on to say, "There is additional 7 information about the dose response of fluoxetine that we will 8 expect that they will submit, and we will have additional 9 discussions with them about how to predict this." Correct? 10 A. Yes. 11 Q. It also says, "Also, there is a mandated safety 12 update that has to be submitted, but, again, we can move 13 fairly far along in the process if you will look at what we 14 have in hand and offer good judgment on that." Correct? 15 A. Yes. 16 Q. So they weren't asking at that time to recommend 17 whether or not it be approved; correct? 18 A. They were recommending them to comment on safety 19 and efficacy. 20 Q. Okay. And is it your understanding that they 21 actually asked the members to make suggestions of what they 22 should look at further with regards to safety of the drug? 23 A. As you pointed out earlier, I was not there. It 24 is standard procedure, though, to heed the recommendations of 25 committee members, to certainly consider their expert opinion. 93 1 What is recommended or what is not recommended, of course, is 2 ultimately the decision of the Food and Drug Administration to 3 make. This is only an advisory committee. 4 Q. Do you know who Doctor Sheldon Prescorn is? 5 A. Yes. 6 Q. Who's Doctor Sheldon Prescorn? 7 A. Doctor Prescorn is a psychiatrist. He also is a 8 psychopharmacologist, a researcher, who is in Wichita in 9 private practice at a research center that he founded. 10 Q. Has he done clinical trials on fluoxetine for 11 Lilly, as far as you know? 12 A. I believe he has. 13 Q. Has he acted as a consultant in any way to Lilly 14 on the issue of Prozac? 15 A. Not that I am aware of. 16 Q. Okay. Were you aware that Doctor Prescorn was a 17 member of the advisory committee in 1985? 18 A. I was not. 19 Q. Were you aware that Doctor Prescorn recommended 20 to Lilly that they run clinical trials or study the issue of 21 the use of Prozac in people suffering from psychotic 22 depression? 23 MR. McGOLDRICK: Judge? 24 (BENCH DISCUSSION) 25 MR. McGOLDRICK: This is the kind of problem I 94 1 was alluding to before. This is far beyond the question as to 2 the original cross. She said -- Ms. Zettler said that the 3 Witness had said that it was -- the committee approved it for 4 safety and efficacy. She's confronted him with that and now 5 she's moving on to what a committee member said. I am not 6 sure that's crossing him on anything and that it's 7 inconsistent with what he said. B, one of the difficulties 8 with the form of the questions is when the question is asked, 9 did so-and-so state so-and-so, if it's indeed improper, by 10 that time it doesn't matter what the answer is because the 11 question reads the transcript, which may be improper. This is 12 hearsay, certainly, and I don't know what all the things here 13 are going to be read. 14 JUDGE POTTER: First of all, Mr. McGoldrick, 15 under Kentucky law, cross-examination is not limited to the 16 topic of direct examination. 17 MR. McGOLDRICK: Yes. 18 JUDGE POTTER: And if I understand your 19 objection, it is that you're trying to impeach him -- what are 20 you trying to do, Ms. Zettler? 21 MS. ZETTLER: He testified, Your Honor, he was 22 some sort of expert at this; that this drug was approved in 23 1985 by the advisory committee, by the FDA, by the 1991 24 advisory committee, and I'm trying to establish that that's 25 not the case; that, in fact, what happened here was that the 95 1 committee made specific recommendations on studies that they 2 would like to see done. Those studies were never done. 3 JUDGE POTTER: I don't think there's a problem 4 here of you asking the question. The problem is that you're 5 trying to put in evidence through this Witness he doesn't know 6 anything about. I mean, if you want to call a separate 7 witness and say I've read the transcript and they made these 8 recommendations, that might be a different issue. 9 MS. ZETTLER: They opened the door, Judge, by 10 getting the guy on the stand and testifying about someplace he 11 supposedly never was and knows nothing about except by 12 hearsay, and getting him to testify that the drug was approved 13 as safe and effective in 1985 by this advisory committee. 14 They opened the door, wide open for this. 15 JUDGE POTTER: Right. I don't have a problem 16 with that. The problem is you've got to do it -- 17 MR. McGOLDRICK: If this were admissible, which 18 I don't believe it is, maybe Ms. Zettler can put that on 19 directly or through another witness, but I don't see it is 20 proper to interrogate this man who wasn't there at the time on 21 what Doctor Prescorn said there. 22 JUDGE POTTER: I'm going to rule this way; that 23 she has a good-faith basis to ask him the questions, can he 24 deny that the committee made this or that recommendation. And 25 when he says I can't deny it or confirm it, then you have to 96 1 go on. 2 (BENCH DISCUSSION CONCLUDED) 3 Q. Doctor Tollefson, do you deny that in 1985, the 4 drug advisory committee recommended that a study of patients 5 with psychotic depression be done with fluoxetine? 6 A. I have no knowledge of that. 7 Q. To your knowledge, has any such study been done 8 at Lilly? 9 A. Studies of depression, including patients with 10 psychotic features, have been conducted. 11 Q. I'm talking about a specific clinical trial 12 structured to study the effects of the drug in psychotic 13 depressed patients. 14 A. Patients who were both psychotic and depressed 15 have been investigated. 16 Q. I'm talking about a specific trial here, Doctor. 17 You've already told us that you did a specific trial on 18 agitated depressed patients; right? 19 A. Uh-huh. Yes. 20 Q. Do you know of a specific trial that was 21 structured and conducted to study this specific patient 22 population? 23 A. I know of a large number of trials that have 24 been conducted in patients with bipolar disease who may be in 25 a depressive phase with psychotic features, and in at least 97 1 three studies that we have sponsored in patients with 2 co-morbid depression and schizophrenia where psychosis could 3 be part of their clinical presentation. 4 Q. Three studies in patients with schizophrenia? 5 A. Correct. 6 Q. When were those studies conducted? 7 A. They have been initiated over the last two 8 years. 9 Q. Your deposition was taken this summer, wasn't 10 it? 11 A. Yes. 12 Q. Why didn't you mention that to us when we asked 13 you then, Doctor? 14 MR. McGOLDRICK: Judge. 15 JUDGE POTTER: Is that at the bottom of the 16 following page here? 17 Q. Have any studies been done with patients with 18 schizoaffective disorder on Prozac? 19 A. Schizophrenia and depression, but not 20 specifically the diagnostic entity of schizoaffective 21 disorder; however, we feel that in the psychiatric literature 22 now, schizoaffective disorder is very, very closely aligned 23 with what we call manic depression or bipolar disease. There 24 is a genetic inheritance pattern in those disorders. They're 25 grouped as common or similar. We have conducted trials, as I 98 1 mentioned, in bipolar patients but not specifically 2 schizoaffective disorder. 3 Q. But you're conducting one now on another drug 4 that Lilly is developing on specifically schizoaffective 5 disorder; correct? 6 A. We now have a developmental program for an 7 antipsychotic medication, and that is one of the clinical 8 groups that's being investigated for this potential 9 antipsychotic agent. 10 Q. Do you believe it's dangerous to give a 11 stimulant drug to a schizoaffective patient? 12 A. I don't think that there's adequate literature 13 to answer that question. 14 Q. I'm asking for your opinion, Doctor, as a 15 psychiatrist. Would you give a stimulant drug to an 16 schizoaffective patient? 17 A. Could you provide me an example of what specific 18 stimulant drug you're talking about, since there are many, 19 many different drugs? 20 Q. Would you give an amphetamine to a 21 schizoaffective patient? 22 A. Personally, I would not, but there are 23 investigators who have written in the literature who believe 24 that a stimulant medication paradoxically may actually improve 25 mania and psychosis. In my practice experience, however, I 99 1 would not give an amphetamine to someone who is experiencing a 2 psychosis. 3 Q. Now let's go back to my original question. Are 4 you aware of any trial -- I'm not talking about patients who 5 may have slipped in the inclusion or exclusion criteria on 6 other trials. Are you aware of any specific trial that was 7 performed by Lilly with Prozac on patients who were diagnosed 8 as psychotically depressed, that specific diagnosis, Doctor? 9 A. No, I'm not. 10 Q. Okay. You were at the 1991 PDAC; correct? 11 A. Yes, ma'am. 12 Q. In fact, you testified there, didn't you? 13 A. Yes, I did. 14 Q. And you testified to all of this stuff that 15 Mr. McGoldrick has been asking you to talk about here today; 16 correct? 17 A. I did. 18 Q. Who actually did these studies that you're 19 talking about here? 20 A. They were conducted by Lilly Research 21 Laboratories. 22 Q. Okay. Who at Lilly Research Laboratories? 23 A. Many, many people over many, many hours. 24 Q. When this data was published as a meta analysis 25 paper, it was published with the first author being Doctor 100 1 Beasley; correct? 2 A. This particular part of the data; that is 3 correct. 4 Q. Do you know where Doctor Beasley is today? 5 A. No, I do not. 6 Q. He's the one who did most of the work on this 7 study, isn't he? 8 A. No. He is the one that wrote the manuscript. 9 Q. Who did the majority of the work on that study? 10 A. There would not be one person who did the 11 majority of the work. This really involved efforts from many 12 different areas of the company to assemble the data: clinical 13 research associates, systems analysts, statisticians, 14 physicians, people in the field that work with our clinical 15 investigative sites in auditing and checking data to make sure 16 that it is indeed in accordance with the case-report forms and 17 clinical records; many people really were involved in 18 generating this information. 19 Q. One of the things he also looked at were the 20 number of suicide attempts; correct? 21 A. Yes. 22 Q. Were you aware, Doctor, of how Doctor Beasley 23 defined what a suicide attempt would be for this paper? 24 A. Basically, Doctor Beasley had indicated that -- 25 in his description in the paper that these would be acts on 101 1 the part of an individual that were likely to be associated 2 with self-harm and where there was no additional evidence that 3 hurting one's self was not the intention of the individual. 4 Q. Who decided whether or not an act would be 5 likely to be self-harm? 6 A. Initially, there was a screening done by several 7 physicians who were blinded to which particular medication or 8 sugar pill that these patients had received. They reviewed 9 any cases where there was any question about whether or not 10 the intent was a suicidal act. 11 Q. Okay. When you say physicians, you mean Lilly 12 psychiatrists? 13 A. That is correct. 14 Q. In Indianapolis? 15 A. Yes. I believe so. 16 Q. Okay. Where did this original data come from? 17 It came from clinical investigators out in the field; correct? 18 A. Yes. 19 Q. So if a clinical investigator out in the field 20 called something a suicide attempt, whether or not Lilly's 21 psychiatrists thought it was likely to cause self-harm, if the 22 clinical investigator called it a suicide attempt, he believed 23 it was a suicide attempt, or she; correct? 24 A. Presumably. 25 Q. So when they came in -- and these guys are 102 1 psychiatrists that you guys hire to run these trials; right? 2 A. Most often for a trial with a psychiatric 3 medication it would be a psychiatrist. 4 Q. Okay. And these guys are, according to Lilly, 5 preeminent psychiatrists in their field; correct? 6 A. They may be men or women that participate; we're 7 not exclusive in using just male investigators, but typically 8 they have established the track record as being a competent 9 researcher. 10 Q. Would you disagree that they are preeminent 11 psychiatrists in their field? 12 A. Some are. 13 Q. Some aren't? 14 A. Preeminent, to me -- my interpretation of 15 preeminent would be the very, very upper echelon, the best of 16 the best. We certainly use people that would fit that 17 particular definition; we also use very good, very capable, 18 very competent psychiatrists all throughout the United States, 19 in Indiana, in Minnesota, in Kentucky, wherever. They're 20 academic, credentialed, qualified people. 21 Q. They're reporting to you that a suicide attempt 22 occurs in one of their clinical trials; correct? That's where 23 this information comes to Lilly from? 24 A. I'm not sure that I'm following what you're 25 saying. 103 1 Q. What I'm saying, Doctor, is that what you looked 2 at was the clinical trial database; correct? 3 A. That is correct. 4 Q. What Doctor Beasley reviewed when he reviewed 5 these instances to see if they would be likely to be 6 self-harm, were instances that occurred in the clinical 7 trials; correct? 8 A. Correct. 9 Q. And they were reported to you by your clinical 10 investigators as suicide attempts; correct? 11 A. They may have been. 12 Q. So Doctor Beasley didn't follow the judgment of 13 the investigator who reported it as a suicide attempt; Doctor 14 Beasley made his own specific judgment as to whether or not he 15 believed it was likely to cause self-harm; correct? 16 A. That's completely incorrect. That's a 17 distortion of exactly what happened. 18 Q. Okay. Tell me exactly what happened, then. 19 A. First of all, the clinical case-report forms 20 were evaluated in three ways. Let me have a drink of water, 21 if I may. In order to be as comprehensive and thorough as 22 possible, Number One, the Hamilton items were evaluated. You 23 remember when we talked about the Hamilton Depression Rating 24 Scale, Item 3, that the number four was indicative of a 25 suicide act. So one way to identify a suicide act in the 104 1 trial, regardless of where else it might have been coded, was 2 did the patient at any time during the trial have an Item 3 3 score of four. 4 A second thing that was looked at were all event 5 terms, which could have included suicide attempt but may have 6 included other adverse-event terms suggestive of suicide. 7 And, last, the text -- in each of these 8 case-report forms there is an opportunity for some narrative 9 comment on the part of the investigator. They were also 10 identified and searched for anything suggestive of a suicidal 11 act or attempt. In any of those that had been classified as 12 an attempt, they should have been indeed recorded as an 13 attempt. There may have been other ones identified with 14 related terms where there was some indecision, some ambiguity. 15 That is what was submitted to a group of physicians at Lilly 16 who were blinded to whatever drug that they had been 17 receiving. They then made a determination whether it was an 18 act or whether it was not. 19 Q. Okay. So all event terms of suicide attempt 20 were used in this evaluation; correct? 21 A. I can't attest to all; certainly the effort 22 would be to have all included. I can't say that there could 23 have been one that was missed or two that were missed, but 24 certainly there was an effort, an exhaustive effort to include 25 them. 105 1 Q. Is it your testimony that you tried to include 2 every single adverse event that was termed suicide attempt? 3 A. That's certainly my understanding. 4 Q. And the other cases would be an adverse event 5 that wasn't necessarily a suicide attempt; correct? 6 A. Correct. 7 Q. Like, for instance, no overdose? 8 A. I would prefer to characterize it as an example, 9 a suicide gesture. 10 Q. I'm talking about event terms here, Doctor. 11 A. All right. Overdose. Yeah. 12 Q. Self-inflicted injury? 13 A. Again, I think that in order to provide the 14 appropriate background on this, any of those event terms, a 15 self-inflicted injury, an overdose, really exist along a 16 continuum, from things that are medically insignificant to 17 life-threatening activities. And any clinician in evaluating 18 suicide, it is not a simple black or white decision; it is 19 with a significant consideration about the medical risk. It 20 could be very insignificant. We refer to those in the 21 clinical literature as a gesture or a manipulative activity. 22 There are others on the other end of the continuum that are 23 very serious, that are taken very seriously. Those would be 24 called a suicidal act. So a simple yes, no, or a dichotomy 25 here is really not an appropriate way to look at that data. 106 1 Q. Where along this continuum did you, the 2 psychiatrists at Lilly, decide you were going to include the 3 events? 4 A. As I indicated, any of those that were coded as 5 an event where it was obvious that it was a suicide attempt 6 presumably were coded as a suicide attempt. I think what I 7 tried to make clear, Ms. Zettler, was that where there was any 8 ambiguity on whether or not it was an attempt, those were 9 blindly submitted to a panel to look at and render a decision; 10 did they appear to be in their clinical perspective an 11 attempt, suicide attempt, or alternatively not an attempt to 12 induce serious harm to one's self. 13 Q. How many suicide attempts were included in 14 Doctor Beasley's analysis, do you remember? 15 A. I believe that there were approximately 13 in 16 the BMJ paper. 17 Q. Okay. 13 where? 13 Prozac attempts? 18 A. No. In fact, there were -- pointing out that 19 this disease is serious and that suicidality is part of the 20 disease, three of the suicide attempts reported in this study 21 occurred during what is called a placebo run-in. In other 22 words, in the week prior to a patient being randomized to 23 either the placebo or one of the other antidepressant agents, 24 they took a sugar pill that first week of the trial. Three of 25 the reported attempts occurred while on that sugar pill during 107 1 the one week before the trial formally began with what we 2 called randomization. 3 Q. How many people on Prozac? 4 A. Well, it would be easiest for me to refer 5 directly to the paper, but -- 6 Q. Have you got that? 7 A. Yes, I do. 8 Q. And? 9 JUROR FELKER: Ms. Zettler, would you mind 10 speaking up? 11 MS. ZETTLER: Sure. I thought this would help. 12 A. (Reviews document) It gives the percentages 13 here. If you were to convert them over, there were six with 14 fluoxetine, one with placebo, I believe, and three with the 15 tricyclics. 16 Q. Okay. So that whole thing you just went through 17 about underscoring that this is a part of depression and there 18 were three placebo suicide attempts was inaccurate. There was 19 one placebo suicide attempt; correct? 20 A. No. The three patients in the one-week run-in 21 were receiving a placebo. 22 Q. Okay. So that was in washout; right? 23 A. No. That was in study lead-in. 24 Q. Which is the placebo washout? 25 A. I don't refer to it as washout. It's called a 108 1 lead-in or a run-in. 2 Q. It's a week-long period where everybody gets 3 placebo; right, Doctor? 4 A. Yes. 5 Q. And that's to try to get whatever drugs are in 6 their system out of their system so you can start studying 7 Prozac; right? 8 A. No, that's not the primary reason. The primary 9 reason for this run-in is to make sure that the patient's 10 depressive signs and symptoms are stable during that one week. 11 In other words, one thing you would not want to see in this 12 type of clinical trial is someone coming in looking either 13 mild or seriously ill and within just a couple days having a 14 dramatic change; it wouldn't be a valid analysis. So 15 typically, and it's convention for these type of studies to be 16 conducted, not only with antidepressants but any of the 17 psychiatric medications, that for that first week they receive 18 a placebo; they're reevaluated after the one week to see 19 whether or not their clinical illness is stable or not; if it 20 is stable and it hasn't significantly changed, particularly in 21 the sense of declining or improving, they then would be a 22 candidate for the study. So it's a period of stabilization 23 and assessment. 24 Q. Okay. The fact is we've got six on Prozac; 25 right? 109 1 A. Correct. 2 Q. Three during the washout, that's nine total; 3 correct? 4 A. Yes. 5 Q. One in placebo during the trial? 6 A. Right. 7 Q. And three on other antidepressants; right? 8 A. I believe so. 9 Q. So that's a total of 13; correct? 10 A. Yes. 11 Q. How many studies did you look at or did Doctor 12 Beasley look at in this? 13 A. I believe there were 17 separate studies, 14 controlled clinical trials. 15 Q. Okay. How many studies had been run on Prozac 16 up to that point in time? 17 A. I'm not sure of the exact number. 18 Q. More than 50? 19 A. Very possibly. 20 Q. More than 75? 21 A. I wouldn't be surprised if there were 100 or 22 more complete studies, not all of them clinical controlled 23 trials, though. 24 Q. Okay. A hundred studies, how many would you say 25 were double-blind controlled studies? Half of them? 110 1 A. I'm only aware of these 17 controlled clinical 2 trials as being part of the New Drug Application, which is 3 what this paper was based on. Any additional studies 4 conducted at that time, of course, which was before I joined 5 the company, I couldn't give you an exact estimate. But my 6 understanding is these are all of the clinical controlled 7 trials that were part of the New Drug Application to the Food 8 and Drug Administration. 9 Q. Okay. So you've limited this study to the 17 10 double-blind controlled studies in the New Drug Application 11 that was submitted to the FDA in 1983, 1984? 12 A. Well, with periodic updates thereafter. 13 Q. Well, let's get this straight, Doctor. Were the 14 17 studies that Doctor Beasley looked at in 1990 or '91, 15 limited to those studies that were filed with the original NDA 16 on Prozac? 17 A. Not necessarily all filed in 1983. Some of 18 those studies I would suspect were still ongoing, and then 19 typically when they are completed, the file is updated for the 20 FDA prior to its final deliberation. 21 Q. And it's your belief that there were no other 22 double-blind controlled studies done on Prozac and depression 23 between that period of time and 1990, when Doctor Beasley did 24 his study? 25 A. I think what I said was I'm not aware of any 111 1 other placebo-controlled double-blind studies that were part 2 of the NDA. 3 Q. So other studies could have been done but they 4 just weren't part of the NDA? 5 A. That's possible. 6 Q. Okay. Let me show you what's been marked as 7 Plaintiffs' Exhibit 227. 8 I believe it's already been entered, Judge. 9 Doctor, to back up a little bit, earlier you 10 said when Mr. McGoldrick was asking you questions, that the 11 first time the issue of using Prozac and the incidence of 12 suicide was raised in 1990 by Doctor Teicher's article; 13 correct? 14 A. It was the first time that I was aware of the 15 issue having arisen at that time. 16 Q. Okay. So let's make sure we're clear on this. 17 That issue was raised by the German government back in 1984; 18 correct? 19 A. I have heard that indication, yes. 20 Q. Have you ever seen any information about the 21 BGA? 22 A. No, I had not; I have not. 23 Q. You have not still, even in your position at 24 Lilly now? 25 A. Correct. 112 1 Q. Have you asked to see any of that information? 2 A. No. 3 Q. Why not? 4 A. In my position, I've talked with a number of our 5 people, my physicians who report to me that work with the 6 product who are familiar with the issue, and I trusted in fact 7 what their analysis of the situation was. 8 Q. Did you know that they did a complete analysis 9 of this issue back in 1985? 10 A. I'm aware of that. 11 Q. Were you aware of that when you testified at the 12 1991 advisory committee meeting? 13 A. No, I was not. 14 Q. You were not aware of the issue being raised by 15 the German government in 1991? 16 A. I was not aware that there was a specific issue 17 that had been raised by the German government; I was aware 18 that the drug was approved and marketed in Germany. 19 Q. But nobody told you that the issue had been 20 raised? 21 A. I didn't know that there was an issue because, 22 as I said, the drug was approved, it was marketed and it was 23 being used in the German Republic. 24 Q. Let's just make sure we get this clear. When 25 you testified before the 1991 PDAC, which Mr. McGoldrick has 113 1 had you talk about earlier today, okay, and you said -- and we 2 went through this and we went through boards and we went 3 through papers -- no credible evidence, right, that you did 4 not know personally, even though you were testifying on behalf 5 of Lilly, that Germany had raised this issue back in 1984; 6 correct? 7 A. I'm not sure what the issue specifically was 8 that you're talking about. I was not aware that -- in fact, I 9 don't believe there was any ongoing concern on the part of the 10 German government at the time I testified. 11 Q. That's not my question, Doctor Tollefson. My 12 question was -- 13 A. Well, I'm just talking about what was relevant 14 to the time frame. 15 Q. Let me ask my question, please. I'll let you 16 answer the question; please let me ask it first, okay? 17 A. Sure. 18 Q. My question is: Were you aware when you 19 testified in 1991 at the PDAC on behalf of Eli Lilly as a 20 Lilly employee; correct? 21 A. Yes. That's correct. 22 Q. You were there at that time? 23 A. Yes. 24 Q. In fact, you had been there for about three or 25 four months at that time? 114 1 A. Yes, ma'am. 2 Q. Okay. Were you personally aware that in 1984, 3 the German government raised the issue of an increased risk of 4 suicide and the use of Prozac? 5 A. No. I was not aware of that specific question 6 back in 1984. 7 Q. Okay. Did you inform the PDAC that the German 8 government had raised that issue back in 1984? 9 A. I did not. 10 Q. Were you aware in 1991, when you testified 11 before the PDAC, that Lilly had in fact hired experts back in 12 1985 and 1986 to look at this issue with regards to the German 13 government? 14 A. I had heard that there were some individuals 15 that have consulted previously with Lilly on those issues but 16 did not know specifically whether it was related to the BGA or 17 the issue in general. 18 Q. Okay. Did you tell the PDAC in 1991, that Lilly 19 had previously -- and I'm talking about prior to Doctor 20 Teicher raising the issue, that Lilly had previously hired 21 experts to look at the issue of increased suicide and the use 22 of Prozac? 23 A. I think as part of the presentation it was made 24 clear that a very thorough and comprehensive analysis of the 25 worldwide data on suicide and Prozac had been made. In fact, 115 1 I was personally aware of the analyses of the depression 2 studies both from the U. S. and those conducted overseas and, 3 in fact, when those data are combined in analysis, the numbers 4 are even more in the favor of Prozac than what I shared with 5 Mr. McGoldrick that was published in the British medical 6 journal. 7 Q. Let's try it one more time. Specifically, did 8 you tell the PDAC that prior to 1990, when the German 9 government raised this issue, that Lilly hired experts to 10 investigate the issue of increased suicide and the use of 11 Prozac, yes or no? 12 A. That was not a question I was asked by the PDAC, 13 so I did not answer that question. 14 Q. Did you volunteer it? 15 A. No. 16 Q. You talked about a lot of stuff and they didn't 17 ask you questions, didn't you? 18 A. No. I think everything I talked about was 19 relative to the question that the PDAC was addressing; that 20 is, is there any credible evidence. So we shared U. S., 21 O.U.S. data, depression, nondepressed patients, 10,000 22 patients; that's what they saw, that's what they deliberated 23 upon. 24 Q. You didn't think the fact that the BGA had 25 raised this issue back in 1984 and Lilly had investigated it 116 1 thoroughly, according to Lilly, back in 1985 and 1986, was 2 relevant to the issue that was raised by the PDAC in 1991? 3 A. Well, first, you've already established I didn't 4 know about it. Second of all, I have no reason to doubt the 5 integrity of Lilly researchers; they're world class. So if 6 they told me that it had been investigated, I would have 7 believed that it was investigated. 8 MR. SMITH: Your Honor, maybe this would be a 9 good time to break for lunch. 10 MS. ZETTLER: To take a lunch break, yes. 11 JUDGE POTTER: Okay. I tell you what, Ms. 12 Zettler, why don't you go on a little longer. 13 MS. ZETTLER: Okay. 14 Did you tell the PDAC that in 1991, the 15 Norwegian government had rejected Lilly's application to 16 register the drug there for sale? 17 A. I did not specifically say that, although I know 18 that the FDA was aware of what countries the drug had been 19 approved and in what countries it had not been approved. 20 Q. PDAC is something that's different from the FDA; 21 correct? 22 A. Correct. 23 Q. So when you say the FDA knew about it, the PDAC 24 didn't necessarily know about it; correct? 25 A. I really couldn't say what the PDAC knew about 117 1 or not. That would be their privileged discussions with FDA 2 officials. 3 Q. My question to you, Doctor Tollefson, as the 4 representative for Eli Lilly at the 1991 PDAC -- and I believe 5 you talked for, what, about an hour when you were there? 6 A. Forty-five minutes to an hour. 7 Q. Presented slides; right? 8 A. Yes, ma'am. 9 Q. Okay. Went over all kinds of data, like Doctor 10 Beasley's study; correct? 11 A. Correct. 12 Q. And we'll get to this later, but Doctor 13 Heiligenstein's violent-aggressive behavior study; correct? 14 A. Yes. 15 Q. Who also hasn't been here yet, by the way. But 16 you went on for 45 minutes to an hour and talked about all 17 kinds of stuff. My question to you is, during your talk did 18 you inform the members of the committee that Norway and Sweden 19 had both rejected the drug for sale in those countries at the 20 time the meeting was being held? 21 A. No, I did not. 22 Q. Did you inform the committee that the German 23 government had raised this very issue of suicidality and 24 violent-aggressive behavior in 1984? 25 A. No. I did not know of the fact at the time, 118 1 although I don't see any purpose in it. 2 Q. Did you inform the committee that there was a 3 package insert in use in Germany, on the day of the advisory 4 committee, that recommended the use of sedatives in people who 5 were suicidal or agitated on Prozac? 6 A. My recollection of that package insert was not a 7 recommendation to use a sedative, merely outlining that as a 8 possible addition to the therapeutic regimen of patients being 9 treated with fluoxetine. To me, that's quite different from a 10 recommendation to do. 11 Q. This, I think, says you may want to use a 12 sedative; correct? 13 A. You may. They were leaving it to the 14 clinician's discretion to determine if it was indicated or not 15 indicated. 16 Q. Did you tell the PDAC that in 1991, when you 17 were there for 45 minutes to an hour talking about how 18 wonderful this drug was and how it didn't cause anybody to 19 commit suicide or violent-aggressive behavior? 20 A. That was not one of the points of discussion. 21 Q. The answer is you didn't; right? 22 A. Again, I did not feel there would be any reason. 23 Q. How about concomitant medication use in the 24 clinical trials? Did you tell the PDAC members about that 25 when you were there? 119 1 A. Not during that particular hearing. 2 Q. Because you didn't feel it was relevant; right? 3 A. Actually, for example, patients in those trials 4 that you've been talking about of 20 milligrams, those taking 5 a concomitant medication were equivalent to those on placebo. 6 There were no statistically significant differences to 7 suggest, you know, a meaningful difference. 8 Q. Did you tell them that Doctor -- well, strike 9 that. Who is Doctor Jan Fawcett? 10 A. Jan Fawcett is a psychiatrist, an expert in 11 depression and suicidality at Rush Presbyterian Hospitals in 12 Chicago, Illinois. 13 Q. He was on the Lilly advisory committee with you 14 before you became an employee of Lilly; right? 15 A. That's correct. 16 Q. Did you tell the advisory committee that -- 17 strike that. 18 Doctor Fawcett also testified at the advisory 19 committee; correct? 20 A. Yes. 21 Q. In fact, he testified on depression and suicide; 22 right? 23 A. Yes, he did. 24 Q. He also testified on behalf of Lilly; correct? 25 A. Yes. 120 1 Q. Did either you or Doctor Fawcett, that you 2 remember, tell the committee that in 1990 Doctor Fawcett had 3 published a paper recommending in patients who had anxiety and 4 they're using Prozac that they may want to get a concomitant 5 benzodiazepine? 6 A. Doctor Fawcett in that 1990 paper had indicated 7 -- he didn't recommend it be done. He indicated that that was 8 an option. I think that's something that physicians are very 9 much aware of, Ms. Zettler. 10 Q. Let's take a look at it. 11 A. You have to recognize one thing, we don't 12 dictate how a physician practices. That is for the 13 physician's best decision-making prowess between physician and 14 the patient, and there are no universal situations where you 15 should do something or you shouldn't do something. 16 Q. And for the physician and the patient to make a 17 judgment on how a patient should be trea2e$, the9 should have 18 all information about medications that they're considering 19 giving the patient; correct? 20 A. Yes. 21 Q. Let's look at Page 42. 22 Has this been entered, Monica, 213? 23 Judge, I don't have enough copies here. We'd 24 move that this be entered and we'll get copies later. 25 JUDGE POTTER: It's numbered what? 121 1 MS. ZETTLER: 213. 2 JUDGE POTTER: It is not in evidence. 3 MS. ZETTLER: Oh, here. Okay. 4 MR. McGOLDRICK: No objection, Your Honor. 5 JUDGE POTTER: Number 213 is admitted into 6 evidence. 7 SHERIFF CECIL: (Hands document to jurors). 8 Q. Okay. Doctor, you've seen this article before, 9 haven't you? 10 A. Yes, I have. 11 Q. And it's an article by Doctor Fawcett that was 12 published in the November 1990 issue of the Journal of 13 Clinical Psychiatry; correct? 14 A. Correct. 15 Q. And the title of the article is Targeting 16 Treatment in Patients with Mixed Symptoms of Anxiety and 17 Depression; right? 18 A. That is true. 19 Q. And on the second page, first column, last 20 paragraph, he talks about combination therapy; right? 21 A. Page 42. 22 Q. There he says, "Suicide prevention is the first 23 consideration in the treatment of major depression with 24 anxiety." Correct? 25 A. That's what he says. 122 1 Q. "Severe anxiety symptoms must be addressed 2 immediately. A few of the antidepressants, especially newer 3 medications, have an early effect on anxiety, which may 4 explain the low compliance rate comment to this whole 5 therapeutic class." Correct? 6 A. Correct. 7 Q. "Aggressive treatment with the benzodiazepine 8 anxiolytic is indicated for immediate relief of anxiety in 9 patients with major depression if they manifest risk factors 10 for suicide." Correct? 11 Q. That's what he says. 12 Q. "Or if the anxiety is severe." Correct? 13 A. Correct. 14 Q. "Or if the antidepressant selected causes 15 jitteriness." Correct? 16 A. Correct. 17 Q. And after that, he specifically refers to 18 Prozac, doesn't he? 19 A. And several other drugs. 20 Q. No. I'm talking about here what causes 21 jitteriness, fluoxetine; correct? 22 A. Yes, as an example. 23 Q. Then goes on to say, "Or is without sedative 24 properties," which is a little different, isn't it, Doctor? 25 A. A little. 123 1 Q. Hmm? 2 A. A little. 3 Q. Okay. 4 Q. Did you tell the PDAC in 1991, that Doctor 5 Fawcett had published an article recommending benzodiazepines 6 be used with patients who were suffering from anxiety? 7 A. As you already pointed out, Doctor Fawcett 8 testified to the PDAC. 9 Q. I'm asking about you. Did you personally tell 10 them? 11 A. I didn't, nor did Doctor Fawcett. 12 Q. Doctor Fawcett didn't either, did he? 13 A. No. 14 Q. Let's go back to Exhibit 227. I apologize for 15 kind of getting off track there a little bit. Have you had a 16 chance to look at Exhibit 227, Doctor? 17 A. No, I have not. 18 Q. Why don't you take a look at it. 19 A. (Reviews document). 20 Q. Have you had a chance to read it now, Doctor? 21 A. I've looked at it. 22 Q. Doctor Wernicke was here yesterday, I believe it 23 was, or the day before -- the days start blending together 24 after a while -- and testified that this was a document that 25 he had sent to Germany revolving around this issue raised by 124 1 the BGA. Okay? 2 A. Okay. 3 Q. And if you look at the second page -- 4 MR. McGOLDRICK: I'm not sure that's right. Can 5 we approach? 6 (BENCH DISCUSSION) 7 MR. McGOLDRICK: Unless I am -- this has been 8 talked about, of course. The representation is that Doctor 9 Wernicke testified that he had sent this to Germany. Unless 10 I'm missing something, this is something from Von Keitz. 11 MS. ZETTLER: I'm sorry. I take that back. 12 (BENCH DISCUSSION CONCLUDED) 13 Q. I'm sorry. Doctor Tollefson, I was mistaken. 14 It was not a document written by Doctor Wernicke; it was a 15 document written to Doctor Wernicke, okay, by Lilly employees 16 in Germany. 17 A. Yes. 18 Q. Okay. They talk about -- on the first page, if 19 you go back to the first page right above the original NDA 20 designation, "Summarize the number of suicides and suicide 21 attempts of which we are currently aware." Okay? 22 A. Yes. 23 Q. And they list the original NDA. Do you see 24 that? 25 A. Yes. 125 1 Q. One suicide, one completed suicide in 2 fluoxetine; one completed suicide in placebo; 13 attempts in 3 fluoxetine and 13 attempts in amitriptyline; correct? 4 A. One. 5 Q. I'm sorry. One. Correct? 6 A. One is correct. 7 Q. All right. So they have here, as far as the 8 original NDA is concerned, 14 suicide attempts on Prozac, 9 either completed or not completed; one on placebo, and one on 10 amitriptyline or other medication; correct? 11 A. The numbers are correct, although I think 12 designating it in that way is really quite misleading. 13 Q. Does it not say here that this is the original 14 NDA information? 15 A. It does, but there may have been patients 16 receiving Prozac in open label; they may have been on 17 humanitarian studies; there may have been many more patients 18 exposed to fluoxetine than amitriptyline. So, again, as we 19 were talking about this issue with spontaneous event 20 reporting, there are a number of things that need to be 21 considered: how many patients were getting the drug, for how 22 long, how many days' exposure, the types of patients. So I 23 think it's a little more -- in my opinion, a little more 24 complicated than just absolute numbers again. 25 Q. Okay. So what you're saying is that all of 126 1 those factors you just talked about may have been taken into 2 consideration to get down to this No. 6 that you talked to us 3 about earlier; correct? 4 A. No. I think they're probably different 5 exercises. They would be part of that, but it's somewhat of 6 an apples and orange comparison here. 7 Q. Doctor, I don't think it is. 8 A. Studies reported to -- all studies that might be 9 reported as part of a safety update and an annual report to an 10 NDA includes all patients receiving the medication at any time 11 in any trial. The specific placebo-controlled, comparator- 12 controlled clinical trials that went into the NDA, the 17 or 13 so studies that I mentioned earlier, are a subset but not the 14 entirety of everything that would be part of a safety -- 15 annual safety update to an NDA. 16 Q. Well, let's talk just about the original NDA 17 because that's what they write here. Okay? So now you're 18 telling us that not only were these studies a part of the NDA, 19 they were a subset of the NDA; correct? 20 A. They were the controlled clinical trials. 21 Q. Do you know that for a fact, Doctor? 22 A. I know that the ones that were looked at by 23 Beasley, et al, were controlled clinical trials. 24 Q. Do you know for a fact that there were no other 25 controlled clinical trials that were run on Prozac, other than 127 1 the ones you looked at? 2 A. That were part of the NDA? 3 Q. NDA; right. 4 A. I don't know that for a fact. I would strongly 5 believe that to be the case but, no, I do not know that as a 6 fact. 7 Q. Regardless, you were able to cut down the number 8 of suicide attempts as reported in Document Exhibit 227 from 9 14 on Prozac to 6; correct? 10 A. No. That's not correct. I think I tried to 11 articulate earlier that the paper that Doctor Beasley 12 published as lead author, the advantage of that, the key 13 advantage is having a placebo-controlled group to establish a 14 base rate. So that the numbers shared from the BMJ article 15 provided an opportunity to look at the number of attempts or 16 acts, for example, occurring as part of the disease in those 17 patients receiving placebo, and compared them in the same 18 clinical trial those patients receiving medications. 19 Q. So now are you saying, Doctor -- let's get this 20 straight. Are you now saying that the only studies you looked 21 at out of the NDA were the placebo-controlled trials? 22 A. No. I'm saying that, as an example, the best 23 way to assess comparative incidents of suicide is to compare 24 patients in the same trial exposed to the medication, versus 25 other people in that same trial who are taking a placebo. 128 1 That is the optimal way to try to answer a question of 2 causality. 3 Q. And the optimal way to do that would be to 4 construct a double-blind placebo-controlled study specifically 5 to look at the issue; correct? 6 A. Placebo-controlled trials that look at 7 suicidality are the optimal way. 8 Q. You didn't do that here, did you? 9 A. These are a series of placebo-controlled 10 clinical trials. 11 Q. None of these studies were constructed 12 specifically to look at the issue of suicidality or 13 violent-aggressive behavior in the use of Prozac; correct? 14 A. I would not agree with that statement. I think 15 all of these studies had a primary emphasis, and I'm sure that 16 it would be reflected in the protocol to evaluate the safety 17 and efficacy of fluoxetine. 18 Q. I'm talking about a trial where specifically 19 scales were used, specific scales like you used in your 20 agitation study, like the adult suicidal ideation 21 questionnaire, Doctor, where the specific objective of the 22 study was to look at suicide or violent-aggressive behavior in 23 the use of Prozac, the specific objection (sic). 24 A. Let me just correct you. The specific objective 25 of the study that you were citing that I published was not 129 1 suicidality; it was assessing the comparative efficacy of 2 fluoxetine and imipramine in agitation amongst agitated 3 patients. That was the primary objective of that study. 4 Q. And that's a study that you came up with the 5 idea for; correct? 6 A. That is correct. 7 Q. That's not a study that Lilly came up with the 8 idea for? 9 A. That is a study that I presented to Lilly that 10 they were very interested in and provided the financial 11 support to make it happen. 12 Q. Prior to that, they had never done a study in 13 agitated depressed patients, had they, to your knowledge? 14 A. I believe they have. I can't give you a 15 specific citation, but I believe that there are studies and 16 certainly populations of agitation. In fact, I do know that 17 the FDA had requested an analysis of the entire package of 18 those 3,065 patients as to whether or not fluoxetine was 19 effective or not in treatment of agitation, and there were 20 more patients than on placebo who had a reduction in agitation 21 while receiving fluoxetine. 22 MS. ZETTLER: Your Honor, I ask that the Court 23 instruct the witness to answer the question. He has not 24 answered my question. I've asked it three times now. 25 JUDGE POTTER: Well, ask it a fourth. 130 1 Q. Let's go back to suicide. Are you aware of any 2 clinical trial that has been conducted by Eli Lilly? And when 3 I say conducted, I mean sponsored, paid for, done in-house, 4 conducted in any way, where the specific objective stated in 5 the protocol was to look at the issue of suicide and the use 6 of fluoxetine? 7 A. The evaluation of suicide in the use of 8 fluoxetine is part of every study. It is one of the 9 objectives. 10 Q. I'm asking about the specific objective of the 11 study, Doctor. 12 JUDGE POTTER: Doctor, I think you can answer it 13 yes or no and then explain your answer if you need to. 14 Q. I'm talking about the specific objective of the 15 study. 16 A. I'm sorry. I'm having trouble with your 17 definition of a specific objective. I'm trying to indicate 18 that these studies have multiple objectives, so I'm trying to 19 decide what is specific and what is nonspecific in your mind. 20 MR. McGOLDRICK: Does Counsel means only, if 21 Your Honor please, maybe -- 22 JUDGE POTTER: No. I think she means spelled 23 out in the protocol. 24 Q. Spelled out as a purpose or objective in the 25 protocol. You did put that in your protocol; right? 131 1 A. Yes. Yes. 2 Q. Because when you send them to the FDA, the FDA's 3 got to know what you're looking for; correct? 4 A. If your question is whether or not it's been in 5 a protocol as a study objective, the answer is yes. 6 Q. It has? 7 A. Yes, it has. 8 Q. Where? 9 A. The study we're talking about, the agitated 10 depression study. There's been another study that was 11 recently completed that was a fluoxetine/placebo 12 investigational antidepressant trial that also included the 13 ASIQ. 14 Q. That's another drug that Lilly is working on 15 right now that you used Prozac to compare it with; correct? 16 A. Correct. 17 Q. And that wasn't a study that was specifically 18 set out to look at suicide either in fluoxetine or the new 19 drug? 20 A. The fact that the ASIQ and the HAMD Item 3 were 21 cited as part of what the analysts would look at, those were 22 outcome measures, of course it was cited there. 23 Q. If we looked at the protocol of that study, 24 Doctor, would it say we are looking at Prozac and this new 25 drug to specifically see if either one of them cause an 132 1 increase in suicidal ideation? 2 A. It would say Prozac, the new drug, and placebo, 3 and to compare the incidence of emergence of suicide. 4 Q. It is specifically in the objective or does it 5 say safety and efficacy? 6 A. It's one of the stated analyses to be performed 7 in the protocol. It is an outlined analysis, Item 3 and the 8 ASIQ. 9 Q. When was that study started? 10 A. Probably around 1991, perhaps. I think '91. 11 Q. You gave your deposition in July of this year; 12 correct? 13 A. Correct. 14 Q. At Page 184, starting at Line 2, do you remember 15 this question and giving this answer, Doctor: 16 "Question: All right. Now, back to where we 17 were going, my question is, in your time at Lilly do you know 18 of any other investigator who at any time in studying 19 individuals being given Prozac for any indication has employed 20 the Reynolds Adult Suicidal Inventory Scale other than 21 yourself on that trial you did before you came to Lilly with 22 respect to agitated depressed patients? 23 "Answer: Not specifically, no." Now you're 24 telling us that there is a study; correct? 25 A. You said with respect to agitated depressed 133 1 patients. This second study is in depression in general. 2 Q. Well, take a look at it together. 3 "Question: All right. Now, back to where we 4 were going, my question is, in your time at Lilly do you know 5 of any other investigator who at any time in studying 6 individuals being given Prozac for any indication has employed 7 the Reynolds Adult Suicidal Inventory Scale, other than 8 yourself on that trial you did before you came to Lilly with 9 respect to agitated depressed patients? 10 "Answer: Not specifically, no." 11 A. Other than myself, that answer would be correct. 12 I'm in charge of all the clinical studies at Eli Lilly in the 13 area of Prozac. The study I was mentioning, the second study, 14 is under me. 15 Q. You're the clinical investigator? 16 A. I don't think that was the question. 17 Q. Yes, it was. Do you want to see it again? 18 A. I'm sorry if I misunderstand you. 19 Q. Did you misunderstand me then? I don't think 20 you did; I think you're misunderstanding me now, aren't you 21 Doctor? "In your time at Lilly do you know of any other 22 investigator who at any time in studying individuals being 23 given Prozac for any indication" -- okay? And now your answer 24 is? 25 A. I am aware of another study. I would consider 134 1 myself to be responsible for the investigators; I am not the 2 investigator myself, so I apologize. 3 Q. Okay. Before there wasn't a study, now there is 4 one; correct? 5 A. There always has been one. I apparently didn't 6 recall or understand specifically your question at the time of 7 the deposition. 8 Q. You had a chance to read that deposition, didn't 9 you? 10 A. Yes, I did. 11 Q. In fact, you made corrections on that 12 deposition, didn't you? 13 A. Yes, I did. 14 Q. You didn't correct that, did you? 15 A. I did not see that, or catch it. 16 Q. Did you misunderstand it again when you reread 17 it? 18 A. Apparently, I did not catch it. 19 MS. ZETTLER: Your Honor, it's a good time to go 20 to lunch. 21 JUDGE POTTER: Ladies and gentlemen, we'll take 22 the lunch recess at this time. As I've mentioned to you-all, 23 do not permit anybody to speak to or communicate with you on 24 any topic connected with this trial and any attempt to do so 25 should be reported to me. Don't discuss it among yourselves. 135 1 We'll stand in recess till 2:00. 2 (JURORS EXCUSED FOR LUNCH RECESS) 3 JUDGE POTTER: I tell you what. We were 4 discussing something in chambers, and I'd like to try to talk 5 about it one more time on the lunch break before I make up my 6 mind. What I'm going to do is meet you-all here at 1:30. I'm 7 give each side ten minutes to do whatever, say whatever they 8 want to say in addition, then I'll make a ruling, and we'll go 9 on. 10 Ms. Zettler, what I need from you, so I can make 11 my ruling in context, is the specific question you're talking 12 about. 13 MS. ZETTLER: Okay. 14 MR. McGOLDRICK: I have made a suggestion over 15 the break to a couple of the Plaintiffs, and I think to the 16 Court, that counsel has not, in fairness, had time to respond. 17 JUDGE POTTER: Why don't we take it up at 1:30. 18 MR. STOPHER: Yeah. Let's just do that. 19 MR. McGOLDRICK: Okay. Fair enough. 20 MR. SMITH: Why don't we go ahead and do it? 21 JUDGE POTTER: Let's go on back and do it, then. 22 (HEARING IN CHAMBERS) 23 JUDGE POTTER: Go ahead, Mr. McGoldrick. 24 MR. McGOLDRICK: Yes, Judge. I'm not asking to 25 argue anything now. What I was going to say is this: We 136 1 perceive this issue to be of absolutely major importance; that 2 being so, my suggestion was and is that we -- that we defer 3 consideration of this issue. We're about to come upon a major 4 break in the trial, and my suggestion is that -- and I would 5 ask Counsel for Plaintiffs if they share the view -- that a 6 sensible thing to do is to defer the issue, let Ms. Zettler 7 finish her cross-examination of Doctor Tollefson save that, 8 and then go forward. 9 If Your Honor were to rule in our favor, we 10 would of course have to bring Doctor Tollefson back. 11 MS. ZETTLER: No. If he ruled in your favor -- 12 MR. McGOLDRICK: I'm sorry. In our favor we 13 wouldn't have to. If ruled in her favor, we would of course 14 have to bring Doctor Tollefson back. But that would give us 15 all an opportunity to do a number of things, but certainly to 16 be able to put the issue to Your Honor in a measured way over 17 that period of time. I would not normally ask that on a 18 ruling certainly on cross-examination, but I do believe that 19 this is of such importance and has such effects on possible 20 scheduling and issues and rebuttal case and all sorts of 21 things that that's what I suggest. 22 Now, I don't know whether Counsel for Plaintiffs 23 is in a position to say at this point whether they concur, 24 object or what have you, but that is the suggestion I would 25 make to the Court, really, regardless of what their view is. 137 1 JUDGE POTTER: First of all, let me ask you 2 this: Has Doctor Tollefson been kept in -- I'm sorry. Let me 3 start over. 4 What is Doctor Tollefson's answer going to be if 5 he is asked? 6 MR. McGOLDRICK: I don't know the answer to 7 that. I have not talked with him about the subject and I 8 don't know that any of my colleagues have, either. We can do 9 that. I don't know precisely what the question is. Clearly, 10 if it relates to 1983 stuff, he may not know much at all, but 11 I have not asked him. I have not asked him that question. 12 JUDGE POTTER: I've thought about Ms. Zettler's 13 question or how it can be limited. And it strikes me that on 14 Page 6 of this exhibit -- 15 MR. McGOLDRICK: What particular exhibit is 16 that? 17 JUDGE POTTER: The Avowal Exhibit 253, the House 18 report, there is a very concise finding, the subcommittee's 19 investigation has revealed that they did and they didn't and 20 there's a finding that Lilly did not report serious adverse 21 reactions associated with the drug use of Oraflex prior to 22 approval of the drug, and there's two sentences to explain it, 23 or actually three. And it strikes me that if you-all wanted 24 to strike some kind of deal about how to not have it come in 25 through this witness, that you come to the agreement that if I 138 1 rule this could come in as cross-examination, at some point 2 you will produce either Doctor Thompson or somebody that will 3 admit that this is in fact true and then get it into evidence. 4 I mean, it can come in maybe not -- because I don't want to 5 fight the whole report. I don't want to go into testimony 6 about what Lilly has done other places other times because 7 we'll be having a whole separate trial, but this one is a very 8 neat, precise finding that can be introduced. I mean, it 9 seems like it's summed up in about three sentences, that there 10 was this drug and they got criticized and there was a finding 11 by the same type of committee that they've been -- maybe not 12 the same type but the same process type committee made a 13 finding adverse to you exactly similar to the types of 14 findings you've been introducing in your favor. I don't know. 15 You want to talk to them about maybe putting off this decision 16 to give both sides an opportunity to think about it some more 17 or to give me some more help on it, or do you-all want to just 18 come back at 1:30? 19 MR. McGOLDRICK: Judge, I think my only -- I 20 will certainly think on Your Honor's suggestion. My quick 21 reaction is, knowing how sensitive the company is to this and 22 how the company thinks that these things are wrong and if they 23 got out into evidence they would like to rebut them, I'm not 24 sure we'd be able to agree to it. I'll think to that, but I 25 still suggest that the whole issue, both in terms of our 139 1 consideration, inter se, the Plaintiffs and the Defendants, 2 and Your Honor's final ruling is one that is better deferred 3 for a range of reasons, but that was the only discussion I was 4 going to make. 5 JUDGE POTTER: Well, of course, I'd like to have 6 as much time to think about them, or at least enough time to 7 think about them, but in all fairness, I have been thinking 8 about it since yesterday. I mean, I haven't gone out and done 9 work, but I've listened and I've tried to weigh things. And 10 there are really two things that strike me as significant 11 here, one, the type of evidence they're going to put in is 12 uncontroverted in the sense that it exists; in other words, 13 it's uncontroverted that there was this federal Congressional 14 panel and there is a finding and an explanation for the 15 finding. I mean, that's quick and easy; it's uncontroverted. 16 It's also -- the evidence that's come in over the trial as to 17 how Lilly's reputation has cumulatively built and built, and 18 each witness has, I feel, maybe some unintentionally but most 19 intentionally have added bricks to that structure. And it 20 really is probably objectionable testimony in the first place 21 because we're calling it character; it is really habit, and 22 it's being introduced to prove that Lilly acted in conformity 23 with that habit in connection with this drug. 24 Why don't I see you-all back here at 1:30. 25 Ms. Zettler, you have your question out. 140 1 You can have the avowal exhibit, if you want. 2 MR. McGOLDRICK: We don't have the benefit of 3 the question yet, because it might help us. If she doesn't 4 have it, fine. 5 MR. SMITH: No. We don't have it at this 6 moment. 7 JUDGE POTTER: And what I'm -- in trying to 8 phrase how it comes in, of course, you would have the right to 9 call witnesses and explain it and all of that, but that's what 10 I'm trying to avoid is... 11 MR. FREEMAN: This is very controverted. 12 JUDGE POTTER: No. But it's uncontroverted that 13 the Senate panel made that finding. 14 MR. McGOLDRICK: The sentence is on a piece of 15 paper. 16 JUDGE POTTER: Just like the talk paper has a 17 sentence on a piece of paper. They say that the talk paper is 18 factually incorrect. And that's what this whole trial is 19 about, and I'm not sure I want a second trial over whether 20 that statement is correct on a piece of paper. 21 MR. McGOLDRICK: Nor do we, Judge. Okay. We'll 22 be back, Your Honor. 23 JUDGE POTTER: Okay. 24 (HEARING IN CHAMBERS TERMINATES; LUNCH RECESS; 25 HEARING IN CHAMBERS RESUMES) 141 1 MR. McGOLDRICK: Judge, we have a suggestion. 2 JUDGE POTTER: Okay. 3 MR. McGOLDRICK: And Mr. Smith will tell me 4 whether I state this wrong or not. We have asked and I 5 believe that Mr. Smith has assented to the following, and if I 6 say it right he'll assent; if I don't, maybe he won't: That 7 the Plaintiffs will defer asking this Witness any question of 8 the sort that we've been talking about, Oraflex or FIAU. The 9 Plaintiffs, of course, do not wish to give up their right to 10 proceed with that; that we would ask Your Honor to defer 11 ruling and we will -- the Plaintiffs will not urge Your Honor 12 to rule now. 13 JUDGE POTTER: Okay. 14 MR. McGOLDRICK: That we would, between now and 15 the end of the Thanksgiving break, provide, if anybody wants 16 to provide, Your Honor with anything on the issue; that if we 17 cannot reach agreement on the issue, the Plaintiffs will have 18 the right to have a witness from Lilly -- I'll agree to bring 19 Gary Tollefson, and maybe we can talk about whether anybody 20 else, but I'll agree to bring Tollefson back to ask him that 21 question and, of course, Your Honor will rule if the parties 22 ask you to do so, I assume, and that's what I would put. Did 23 I say that all right? 24 MR. SMITH: Except for the fact that I would be 25 able to propound the question to Mr. Tollefson as Mr. 142 1 Tollefson is the witness. 2 MR. McGOLDRICK: Mr. Smith asked that he 3 personally be permitted to do that, not any particular 4 question. We would fight like cats and dogs about what 5 question he could propound, if any. But if Your Honor allowed 6 any to be propounded, we would not object to Mr. Smith doing 7 the propounding. 8 JUDGE POTTER: The reason he asked that is, I 9 don't know if anybody told you, we kind of have a one-lawyer, 10 one-section rule. 11 MR. McGOLDRICK: I did understand that. 12 JUDGE POTTER: I don't want to upset the 13 agreement, but I will add one thing to it, not to it but one 14 thing I've had is, Ms. Zettler, when we were talking about 15 this before, I gave you some thoughts about where I was. An 16 additional thought I've had over the lunch break is that you 17 have a hearsay problem in this document and, you know, it is 18 a -- this is -- you're introducing this to prove that they 19 have breached their protocols or rules or regulations, and 20 really this is not direct evidence, this is hearsay. This is 21 a Congressional report; it is not a judicial judgment, so you 22 might think about that if you-all can't work it out. You 23 mentioned at some point that you thought there was a 24 misdemeanor conviction. And I don't know if there is or not, 25 but a misdemeanor conviction going to the same issue might not 143 1 have the hearsay. What I don't want to do is get down to 2 where this thing doesn't work out and I'm still in a half-hour 3 bind where people haven't thought about what my problems are. 4 MR. McGOLDRICK: I do understand that. 5 JUDGE POTTER: I'm not telling you-all what to 6 do; that is just two additional thoughts that came to me and, 7 quite frankly, with some help from another judge over the 8 lunch break. 9 MR. McGOLDRICK: Could I, in that respect, Your 10 Honor, ask two questions? One, we were having a number of 11 folks back at our place at noon trying to make sure we 12 understood precisely which part Your Honor was referring to 13 and we were having disagreement. 14 JUDGE POTTER: I wasn't ruling. 15 MR. McGOLDRICK: I understand, but -- 16 JUDGE POTTER: I wasn't saying that's the way 17 they had to do it; I was just trying to put it in a posture, 18 because I see it this way. I see, is it admissible; is it 19 admissible to cross-examine this fellow; is it admissible on 20 its own. You have a hearsay problem. Okay? Maybe. And then 21 you have how does it come in. If it comes in, what is it. 22 And is it relevant. If I decide it's relevant, then I have 23 the problems is it unduly prejudicial, is it going to just 24 create a whole another trial. And in suggesting that, I would 25 only allow in, you know, sort of the finding part of it, what 144 1 I was trying to do is cut down on my own mind the second trial 2 kind of thing, because this says what it says and that's not 3 in dispute, and maybe that does trigger a whole trial. If it 4 does, you're certainly entitled to it. It also I think maybe 5 cuts down on the prejudicial because it's neat and it's clean 6 and it's not a lot of other things. So I wasn't telling you 7 how to put it in, but those are some additional thoughts that 8 occurred to me is the hearsay problem and somebody mentioned a 9 misdemeanor conviction. I don't know if there is or not. 10 MS. ZETTLER: Can I clarify something, Judge? 11 Is your concern regarding the hearsay is whether or not there 12 was a charge or a conviction in this case? 13 JUDGE POTTER: I don't know that there has been. 14 MS. ZETTLER: I guess what I'm -- 15 JUDGE POTTER: No. The hearsay would be that 16 this report itself is hearsay. I mean, it's -- you know, if 17 there had been a judgment somewhere that said they did this I 18 think it would be more likely to get around the hearsay 19 problem, presumably a conviction, I don't know. 20 MR. SMITH: I'm just thinking out loud. 21 Wouldn't the fact that it was used to impeach or on 22 cross-examination, wouldn't that cure the hearsay problem? 23 JUDGE POTTER: That may avoid the hearsay 24 problem. I don't know. 25 MR. McGOLDRICK: Maybe these are bridges we 145 1 don't have to cross if we can reach agreement about it. And 2 one of the things we'll be doing, in addition to trying to 3 give Your Honor help, is seeing if we can reach agreement 4 about it. I don't know if we can. 5 I'm constrained to say one thing at the risk of 6 wasting Your Honor's time because I know the other side will 7 disagree. It is my understanding and I was advised at lunch 8 hour that what is stated in the paragraph which was alluded to 9 is in fact false. Those facts are inaccurate. That doesn't 10 mean they aren't in there; they are of course in there, but 11 that they are in fact false. 12 The other thing I would mention is this: If 13 Your Honor suggested, and I'm trying to find a way to limit it 14 so if we end up having to fight about this maybe we could 15 reach an agreement that would cause us not to fight, is that 16 if -- Your Honor suggested that maybe Ms. Zettler prepare a 17 question, if we could know what the question is, it might make 18 a difference as to what our defense is. 19 MS. ZETTLER: With the caveat of just hearing 20 the Judge's suggestion and that this is my lunch-hour draft, 21 something to the effect of... 22 JUDGE POTTER: (Hands document to Mr. 23 McGoldrick). 24 MR. McGOLDRICK: Are you offering that to me, 25 Your Honor? 146 1 JUDGE POTTER: I'm offering it to you. She'll 2 get it back from you and make a Xerox copy if she wants it. 3 And, Mr. McGoldrick, you said you understood my ruling. 4 Again, I don't want to upset your agreement, but as of this 5 instant, I don't know that I've made a definitive ruling. I 6 think I've indicated to you facts had changed since I ruled 7 before and I was reconsidering it, and reconsidering it 8 extremely seriously. So you said you didn't want to waste any 9 more time because you realized I had ruled, I don't think I 10 have. 11 MR. McGOLDRICK: I think I misspoke if I said 12 that, Your Honor. I didn't take it that Your Honor had ruled. 13 I didn't understand that. 14 JUDGE POTTER: All right. Okay. 15 (HEARING IN CHAMBERS CONCLUDED; THE FOLLOWING 16 PROCEEDINGS OCCURRED IN OPEN COURT) 17 SHERIFF CECIL: The jury is now entering. All 18 jurors are present. Court is back in session. 19 JUDGE POTTER: Please be seated. 20 Doctor, I'll remind you you're still under oath. 21 Ms. Zettler. 22 MS. ZETTLER: Thank you, Your Honor. 23 Doctor Tollefson, before we broke for lunch you 24 were telling us now that you believe there is a study on 25 schizoaffective disorder in which Prozac is a part; correct? 147 1 A. I believe that I indicated that there are not 2 any studies being conducted at present specifically on the 3 diagnosis of schizoaffective disorder. 4 Q. Okay. So no studies, not even another Lilly 5 drug, where fluoxetine is an arm of that study? 6 A. That is correct. 7 Q. Okay. Let's go back to Exhibit 227; do you have 8 that? 9 A. Yes, ma'am. 10 Q. I think we established earlier that in Doctor 11 Beasley's meta analysis report to the PDAC there were 13 total 12 suicide attempts that were discussed in that paper; correct? 13 A. Yes, ma'am. 14 Q. And six of those were on Prozac? 15 A. Yes. 16 Q. Now, if you'd look at the second page of 17 Exhibit 227, do you see that? 18 A. Yes, ma'am. 19 Q. About halfway down the page it says Total 20 Suicides? 21 A. Yes. 22 Q. It says fluoxetine, seven? 23 A. Yes. 24 Q. And this is back in October of 1986; correct? 25 A. The memorandum is dated October 3, 1986. 148 1 Q. Okay. So at that time, Barbara Von Keitz and 2 Hans Weber are reporting that they are aware of seven Prozac 3 suicides in the clinical trials, correct, to date? 4 A. I believe that's the case. 5 Q. Okay. And they're also aware of five placebo 6 suicides; correct? 7 A. Yes. It looks like these are drawn from studies 8 from several countries. 9 Q. Under Suicide Attempts it says 47 on Prozac; 10 correct? 11 A. Yes. 12 Q. Two on placebo, attempts? 13 A. Yes. 14 Q. And two on amitriptyline? 15 A. Yes. 16 Q. And one on mianserin; right? 17 A. Yes. 18 Q. Can we say three total active comparators? 19 Would that be fair? 20 A. Yes. 21 Q. Okay. So as of October of 1986, in Prozac 22 clinical trials there are a total of 54 suicides and suicide 23 attempts; correct? 24 A. That's what the document says. 25 Q. And this is just as of October of 1986? 149 1 A. Yes. 2 Q. Are you aware of any other clinical trials that 3 were performed on Prozac after October of 1986, in depression? 4 A. There are a series of always ongoing trials of 5 Prozac in depression, so I would suspect that there were 6 indeed trials that were still under way or perhaps had not yet 7 been started as of '86. 8 Q. Okay. Fifty-four Prozac suicides and suicide 9 attempts as of October of '86, without counting any studies 10 that were done after October of 1986 and before 1990, when the 11 database was cut off to do Doctor Beasley's study; correct? 12 A. Yes. 13 Q. And in Doctor Beasley's study that you discussed 14 today with Mr. McGoldrick, it only discussed six suicides or 15 suicide attempts on fluoxetine; correct? 16 A. Correct. 17 Q. I believe yesterday you testified that you did 18 not believe that Prozac was an activating drug; is that true? 19 A. I believe that in the majority of patients that 20 take Prozac it is not an activating drug. 21 Q. You obviously know Doctor Greist; correct? 22 A. Yes. 23 Q. You're aware that Doctor Greist testified 24 yesterday that -- or the day before that one of the major 25 side-effect profiles of Prozac is activation and stimulation? 150 1 A. I was not aware of his testimony. 2 Q. Do you disagree with that, Doctor? 3 A. I think that one of the more common side-effect 4 profiles of Prozac is this so-called activation term that was 5 discussed yesterday. As far as it being something that is a 6 significant problem in the majority of patients who take the 7 medication, I would say it is not. 8 Q. Would you agree that generally tricyclics are 9 not stimulating and activating? 10 A. No. I would not agree. 11 Q. Do you remember again giving your deposition in 12 July of this year? 13 A. Yes, ma'am. 14 Q. Well, strike that. Are you aware that Doctor 15 Greist testified while he was here that generally tricyclics 16 are not stimulating and activating? 17 A. No, I wasn't aware of that. 18 Q. Before you did your study on agitated depressed 19 patients, Doctor Beasley did a meta analysis of sorts or a 20 review of clinical trials in Prozac for activation; correct? 21 A. My recollection is he looked at two fixed-dose 22 studies relative to activation and sedation as adverse events. 23 Q. And in his review of that, he found that more 24 patients on Prozac became activated than sedated; correct? 25 A. Yes. That was across the dose range of Prozac 151 1 up to 60 or 80 milligrams, I believe. 2 Q. Were you aware, Doctor Tollefson, that back in 3 1979, Doctor Irwin Slater found that -- strike that -- that 4 Doctor Irwin Slater allowed for the amendment of protocols to 5 allow for these benzodiazepines in controlling agitation in 6 patients on Prozac? 7 A. No. 8 Q. Yesterday you talked about the differences 9 between agitation and nervousness; do you remember that? 10 A. Yes, ma'am. 11 Q. Can you tell us again what the differences are? 12 A. Agitation is, typically, motor manifestation or 13 muscular features. I think we used some examples such as 14 pacing, inability to sit still, wringing of one's hands or 15 pulling or tugging at things. In contrast, anxiety or 16 nervousness involves more of a psychological feeling of being 17 on edge, apprehensive, features like that. 18 Q. If the clinical investigator were to report that 19 somebody was suffering from agitation, would it be appropriate 20 for that event to be reported to the FDA as nervousness? 21 A. If the -- if the investigator felt that it 22 included nervousness, then it would be appropriate. 23 Q. What if the investigator just said agitation? 24 A. At least in my clinical opinion, it would be a 25 motor manifestation more than a psychological one. 152 1 Q. There's a difference between agitation and 2 nervousness; correct? 3 A. Yes. Although in some patients there may be an 4 overlap, but I think they are different. 5 Q. What about a patient who is so agitated that 6 they needed IV Valium to help them control that agitation? 7 Would it be appropriate to report that to the FDA as 8 nervousness? 9 A. Not knowing that individual case, I couldn't 10 say. If the person was also nervous, then it would be 11 appropriate. 12 Q. Would it be appropriate in that situation to 13 report both agitation and nervousness? 14 A. I think as far as a description on a case 15 report, one might indicate both, but that would be at the 16 clinical investigators' discretion as to what degree they felt 17 one or the other was prominent. 18 Q. Who fills out 1639s for adverse events that 19 occur on Prozac? 20 A. It may be physicians that are investigators; it 21 could be Lilly physicians if they happen to hear about an 22 adverse event or receive a report of a potential adverse 23 event. 24 Q. What about on clinical trials? Isn't it true 25 that it's Lilly who fills out the 1639s and not the 153 1 investigator? 2 A. Yes. 3 Q. Yesterday you gave the opinion that activation 4 was somewhat like drinking a half a dozen cups of coffee; do 5 you remember that? 6 A. I think I cited that as an analogy of how 7 someone might feel. 8 Q. Would you agree that when somebody drinks six 9 cups of coffee they tend to feel a little jittery? 10 A. They can. 11 Q. Is jitteriness used in regards to coffee 12 consumption the same as jitteriness that's been used with 13 regards to Prozac? 14 A. I think a similar phenomenon. 15 Q. So is it your testimony, Doctor, that all 16 activation that's experienced by patients on Prozac relate to 17 the same feeling you would get if you drank too much coffee? 18 A. No. 19 Q. There are cases where activation in Prozac can 20 be extremely serious; correct? 21 A. There are varying degrees of activation. 22 Q. Are you familiar with J. Amsterdam? 23 A. Yes. 24 Q. Can you tell me who Doctor Amsterdam is? 25 A. A depression researcher in Philadelphia. 154 1 Q. He's done clinical trials on Prozac, has he not? 2 A. Yes, he has. 3 Q. Doctor, I'm going to show you what has been 4 marked as Plaintiffs' Exhibit 257. I'd like you to take a 5 look at it, please. 6 A. (Reviews document). 7 Q. Doctor, I'm not going to ask you about the 8 entire article, I just want to ask you this right now. Have 9 you seen this article before? 10 A. No, I have not. 11 Q. This is an article from the September 1994 issue 12 of the Journal of Clinical Psychiatry, is it not? 13 A. Yes, it is. 14 Q. And its title is The Efficacy of Alprazolam in 15 Reducing Fluoxetine-Induced Jitteriness in Patients with Major 16 Depression; correct? 17 A. Yes. 18 Q. And it's authored by J. Amsterdam and a list of 19 other doctors; correct? 20 A. Yes. Correct. 21 Q. Do you recognize these other authors? 22 A. No, I do not. 23 Q. Was Doctor Amsterdam ever on Lilly's psychiatric 24 advisory committee, as far as you know? 25 A. I don't believe so. 155 1 MS. ZETTLER: Your Honor, we'd offer Exhibit 257 2 into evidence. 3 MR. McGOLDRICK: I don't think I have any 4 objection, Your Honor. The Witness hasn't seen it, but it's 5 okay. 6 JUDGE POTTER: Okay. Be admitted. 7 SHERIFF CECIL: (Hands document to jurors). 8 Q. Doctor, the results of Doctor Amsterdam's study 9 is that out of 54 patients that were included in this study, a 10 third of them became jittery on fluoxetine; correct? 11 A. That's what Doctor Amsterdam reports here, yes. 12 Q. Okay. And they also became jittery enough to 13 require the co-administration of a benzodiazepine; correct? 14 A. I'm not sure. The way this reads, the 15 investigator was interested in studying alprazolam in the 16 treatment of jitteriness. So that I'm assuming, from what 17 I've been able to read so far, that someone who was jittery 18 then met the investigator's criterion so he chose to start the 19 alprazolam. I don't know how it relates to severity of the 20 jitteriness. 21 Q. Okay. Well, let's talk about their definition 22 of jitteriness. Okay? At the first full paragraph on the 23 right-hand column where he starts to get into the actual 24 effects of the study, about halfway down the paragraph it 25 says, "However, the selective influence of these drugs on 156 1 postsynaptic serotonin receptors has resulted in a unique 2 constellation of adverse effects characterized by 3 restlessness." 4 A. I'm sorry. May I ask which -- are you on the 5 first page on the right column? 6 Q. Sure. First page, right column. This is the 7 paragraph by Doctor Heiligenstein. 8 A. Yeah. Okay. Sorry. 9 Q. The paragraph itself starts with "comparative 10 studies have consistently." 11 A. Thanks. I've got it. 12 Q. I'm starting the second full sentence. 13 "However, the selective influence of these drugs on 14 postsynaptic serotonin receptors has resulted in a unique 15 constellation of adverse effects characterized by 16 restlessness, nervousness, agitation, anxiety and 17 irritability, collectively termed jitteriness." Do you see 18 that? 19 A. I do. 20 Q. They also say in the second paragraph, about 21 halfway down, "There have, however, been no systematic studies 22 examining the efficacy of concurrent benzodiazepine therapy on 23 selective-serotonin-reuptake-induced jitteriness and most 24 information in the literature appears to be anecdotal." 25 Correct? 157 1 A. Correct. 2 Q. Has Lilly ever done a study on the effects of 3 benzodiazepines on the jitteriness adverse events experienced 4 by Prozac patients? 5 A. I'm not aware of any. 6 Q. Why not? 7 A. I think that the recommended dose that we see is 8 20 milligrams, and in our experience in the controlled 9 clinical trial data, there has been, looking back in those 10 studies, no difference -- no statistically significant 11 difference in the use of sedative hypnotics in patients on 20 12 milligrams of Prozac versus those receiving placebo. 13 Q. Well, Doctor Amsterdam used 20 milligrams of 14 fluoxetine per day on his study; correct? 15 A. Correct. 16 Q. And he found in his study that a third -- 17 thirty-three and a third percent of the patients became 18 jittery; correct? 19 A. That's correct. Although, as I had commented on 20 earlier, there's an issue here, I think, that one needs to 21 consider as to how serious or severe the jitteriness is. You 22 know, when we record or see patients in clinical experience 23 with an adverse event, they could be minor or mild or they 24 could be quite severe. The more important, I think, number is 25 were they adverse events that were serious enough that a 158 1 patient would want to stop treatment? Typically, these -- and 2 you mentioned Doctor Beasley's manuscript earlier. In Doctor 3 Beasley's experience in the manuscript he characterizes that 4 these side effects very often are mild and they're very 5 transient; they go away in one or two weeks. So the majority 6 of patients, the vast majority don't actually have to stop 7 taking their medication. 8 Q. How are we going to know that from the Prozac 9 clinical trials, Doctor Tollefson, if you allowed for the 10 concomitant administration of benzodiazepines in the clinical 11 trials to treat agitation? 12 A. I believe that in many of the trials a 13 concomitant benzodiazepine to treat agitation was not allowed. 14 Q. How about benzodiazepine use in general? 15 A. I believe in the majority of the trials it was 16 exclusionary. 17 Q. Can you point us to one of the seventeen trials 18 that Doctor Beasley reviewed in his analysis that you went 19 over this morning where concomitant medications were not 20 allowed? 21 A. Well, I know in the -- well, now you're asking 22 me a different question. I think we were talking about 23 benzodiazepines specifically for nervousness or activation. 24 The pivotal studies, for example, in those trials did permit 25 for the concomitant use of a sedative hypnotic agent to help 159 1 with sleep, with one exception, I believe; they did not 2 specifically allow for -- in fact, they excluded concomitant 3 benzodiazepines for anxiety or agitation. So those are really 4 two different side-effect profiles. 5 Q. I'm asking about the 17 studies that Doctor 6 Beasley reviewed. Can you point us to one specific study 7 where they were not allowed? 8 A. I'm sorry, but where what was not allowed, 9 treatment for agitation or treatment with a sedative hypnotic? 10 Q. Either one. 11 A. Well, treatment with a benzodiazepine for 12 agitation I do not believe was allowed in either Study HCAF or 13 HCCP, which were pivotal studies. 14 Q. HCAF was Protocol 27, was it not? 15 A. Correct. 16 Q. It's the imipramine/placebo/fluoxetine study; 17 correct? 18 A. Yes. 19 Q. And you believe there were no concomitants 20 allowed in that study? 21 A. No. I believe what I said is that concomitant 22 medications were allowed for the purpose of patient's sleep; I 23 do not believe that they were permissible for the treatment of 24 agitation or activation. 25 Q. So if we look at this exhibit where 24 percent 160 1 of the patients on Prozac were given concomitant medications, 2 it's your belief that that is sedatives as opposed to 3 benzodiazepines? 4 A. Well, let me try to clarify. There are a number 5 of sedative hypnotic agents which are also benzodiazepines, so 6 that some of the sedative hypnotics administered may have been 7 in the benzodiazepine class or family of medications. 8 Q. Okay. So you don't know how those were actually 9 administered during the clinical trial? I mean, you could say 10 you only give this for sleep, but they could have been giving 11 them out during the day, too? 12 A. I suppose that's possible. I mean, we have to 13 assume some clinical responsibility on the part of the 14 physicians taking care of those patients. 15 Q. Would that clinical responsibility include 16 reporting adverse events that required the administration of 17 concomitant medications, such as insomnia or agitation? 18 A. In accordance with the particular protocol, yes, 19 it would. 20 Q. So if a clinical investigator gave a concomitant 21 medication, say, for insomnia and didn't report that as an 22 adverse event in the clinical report form, that would be 23 inappropriate, as far as you're concerned? 24 A. No. I don't believe that's what I said. I said 25 it depends on the protocol and whether or not it was in 161 1 accordance with or not in accordance with the protocol. 2 Q. Do you know of any protocol at Eli Lilly where 3 the co-administration of a benzodiazepine or a sedative for 4 sleep was allowed and the investigator was not required to 5 report the event that required the administration of that 6 drug? 7 A. I can only cite my experience in clinical 8 investigation, and that is that, typically, adverse events 9 during a trial would be defined as things that either first 10 appeared during the course of a trial or worsened during a 11 trial. If a patient came into a trial and one of their 12 symptoms, which is one of their nine criteria for depression, 13 was insomnia and they had -- let's say they -- as an example, 14 they could only sleep three hours at night, and if I saw them 15 a week later in the study and they were still only sleeping 16 three hours a night, I wouldn't consider that to be an adverse 17 event. I would consider it a symptom of the depression that 18 might merit use, with discretion, of a medication to help for 19 sleep. 20 Q. I thought you testified earlier that anything 21 that happens to a patient on a clinical trial is reported as 22 an adverse event. And I believe Mr. McGoldrick made an 23 example of the ceiling falling in on them. 24 A. I'm sorry. I don't remember that example. 25 Q. Do you disagree that everything that occurred to 162 1 a patient during a clinical trial was reported as an adverse 2 event? 3 A. I think in some protocols it is specifically 4 delineated that if the event was felt to be -- not the event, 5 if the symptom that was observed was felt to be part of the 6 depression and it was not a first appearance or a worsening, 7 that then that was not automatically an adverse event; it was 8 considered to be part of the disease that the patient came 9 into the study with. 10 Q. So you're telling this jury that if somebody is 11 given a prescription of fluoxetine -- and this is an example 12 that's been used in this trial, Doctor Tollefson, is given a 13 prescription for fluoxetine and is hit by a bus walking across 14 the street before they get their prescription filled, that's 15 going to be reported as an adverse event, but a condition that 16 they walk into the trial with or get within that first week, 17 as you just said, is not going to be reported as an adverse 18 event? 19 A. No. Again, it would be necessary for me to 20 clarify. That is not what I said. What I said was, if a 21 patient has a particular feature of their depression, for 22 example, insomnia, they enter the study and it hasn't changed; 23 in other words, this is not a new appearance during the study 24 or it has not gotten worse during the study, it may well be 25 considered then as part of the disease because it was present 163 1 before the patient ever began on medication and it had not 2 changed. 3 Q. Isn't it true that on the SS -- the signs, 4 symptoms and illnesses forms of the clinical report forms 5 there is a space to indicate whether or not the investigator 6 believes that an event is study-drug related? 7 A. Yes. 8 Q. And isn't it true that in the majority of the 9 cases the investigators are told to list the adverse event 10 regardless of when it began, as long as it occurs during the 11 clinical trial, as long as it is ongoing or occurs during the 12 clinical trial, and then put whether or not the adverse event 13 is, in their opinion, related to the drug? 14 A. That certainly is one way that a protocol can be 15 constructed; you're correct. 16 Q. I believe it was your testimony yesterday that 17 all adverse events, however you define them, that occurred 18 during the clinical trials and spontaneously, that Lilly 19 became aware of, were reported to the FDA; correct? 20 A. I believe I said we make every effort to report 21 all, but I couldn't guarantee that it was 100 percent. 22 Q. Doctor Tollefson, I'm going to show you what has 23 already been marked and entered as Plaintiffs' Exhibit 151. 24 Judge, could you see if the -- I'm not sure if 25 this was in our original list or not, I mean, for the jury 164 1 today. 2 JUROR FRANKLIN: We have one. 3 JUDGE POTTER: They have it. 4 Q. You have it? Okay. 5 Okay. Doctor, can you see that? 6 A. Yes, ma'am. 7 Q. Doctor, I'm going to represent to you that this 8 has been established as a listing of adverse events that we 9 were able to obtain from the FDA, spontaneous-reporting 10 information on Prozac up until July of 1993. 11 A. Okay. 12 Q. Okay? You've seen Exhibit 151 before, haven't 13 you, at your deposition? 14 A. Yes. 15 Q. And Doctor Thompson testified earlier that this 16 appeared to him to be a listing of spontaneous reports for 17 Prozac without the clinical trial reports that were contained 18 in the DEN database, okay, as of December of 1992. Do you see 19 that? 20 A. I see the date, yes. 21 Q. Okay. What I'd like you to do is go through 22 with me and look at some specific adverse events. 23 MR. McGOLDRICK: Ms. Zettler, can we approach 24 the bench for just a second, if the Court please. 25 (BENCH DISCUSSION) 165 1 MR. McGOLDRICK: Judge, I may be here for the 2 wrong reason; I'm just not sure. Do we have a copy of what's 3 up on the board, or is this it? 4 MS. ZETTLER: No. It's different. It came in 5 through Doctor Breggin. 6 MR. McGOLDRICK: My apologies. 7 MR. MYERS: It's not in evidence. 8 MS. ZETTLER: The basis for that is in evidence. 9 MR. McGOLDRICK: But it's not in evidence? 10 (BENCH DISCUSSION CONCLUDED) 11 Q. Okay. Doctor Tollefson, these are numbers of 12 adverse events that were given to us by the FDA that exist or 13 existed in the spontaneous reporting system as of July of 14 1993. Okay. Now, what I'd like you to do is help me compare 15 some of these. Could you look on Exhibit 151 and tell me how 16 many instances of depression were reported in the Lilly DEN 17 database as of December of 1992? 18 A. Just for -- if I may ask you a point of 19 clarification. It looks like we're talking about two 20 different time intervals here? 21 Q. This is FDA's database. 22 A. These are not comparable? 23 Q. Right. 24 A. This says postmarketing and that looks like it 25 includes data from prior to the approval and marketing of the 166 1 drug. 2 Q. These are all of the events that have been 3 reported by Lilly to the FDA on 1639s, okay, that includes if 4 it's serious clinical trial data, et cetera. That, I think 5 Doctor Thompson testified was what he believed a listing of 6 spontaneous events without the clinical trial serious events. 7 So they were completely postmarketing events only. So if 8 you'll look up on that exhibit depression. 9 A. Okay. I have it. 10 Q. Tell me how many instances of depression were 11 maintained at Lilly in December of 1992. 12 A. I'm sorry. Did you say maintained at Lilly? 13 Q. Well, let's put it this way. That Lilly was 14 aware of on Prozac in 1992, as illustrated by Exhibit 151. 15 A. If I'm looking at the document correctly what I 16 see is that there were 2,168 spontaneous reports of depression 17 in the postmarketing interval. 18 Q. Okay. Now, in the FDA's database there are 933 19 listed. Do you see that? 20 A. Yes. 21 Q. Do you have any explanation why the FDA's 22 database would have less than half the number of the instances 23 of adverse events related to depression than Lilly would have 24 in their database at Indianapolis? 25 A. Possibly that some of these terms are being 167 1 directed in different ways. Prior to 1989, things like 2 suicidal ideation may have mapped to depression. I'm not sure 3 here. You have the term suicide attempt up there. I'm not 4 sure. The numbers are not in agreement. I'm also, though, 5 not sure if they are fair comparisons, so I can't answer. 6 Q. Well, should there be any difference with the 7 number of spontaneous adverse events that the FDA has 8 information on and the number that Lilly has information on? 9 A. Well, it may just be time. I don't -- you know, 10 I'm not sure what kind of a lag, for example, the FDA has in 11 recording. Let's say, theoretically, that the FDA is running 12 six months behind in this data collection, there could be a 13 number of events that have been reported through Lilly that 14 have not yet been accounted for in your chart just as one 15 possible explanation. I don't know if that's the case. 16 Q. That might be true except for one thing. This 17 is six months at least older -- seven or eight months older 18 than that document there. Okay? 19 A. Depending on what their turnaround time is, I do 20 not know what that is. 21 Q. How about overdose? Look up overdose and tell 22 me how many overdoses Lilly was aware of in December of 1992. 23 MR. SMITH: Nancy -- 24 JUROR FELKER: I don't know if I can ask this 25 question or not. 168 1 JUDGE POTTER: I'm sorry, ladies and gentlemen. 2 Do you want Ms. Zettler to speak up; is that what it is? 3 JUROR FELKER: No. I want something clarified 4 about this one and that one. 5 JUDGE POTTER: If you-all have an additional 6 question, at the break you can write it down, but other than 7 that, except to just ask her to speak up. 8 Q. Let me make sure. Maybe I can help the 9 confusion a little bit. Doctor, I think there's a little 10 confusion here, so let me illustrate what we've done with this 11 so that we can all understand. Okay. What we did was we sent 12 a Freedom of Information Act Request to the Food and Drug 13 Administration and asked them for a list of all of the 14 spontaneous reports or all of the reports of adverse events 15 that they had on Prozac. Okay. They wrote back to us and 16 told us that what they had in their system were all 17 spontaneous reports that were made on the drug and any serious 18 and unexpected clinical trial adverse events that were 19 reported. Is that consistent with your understanding of how 20 the reporting works with 1639s? 21 MR. McGOLDRICK: Excuse me. Could we approach 22 the bench? 23 (BENCH DISCUSSION) 24 MR. McGOLDRICK: Your Honor please, perhaps 25 there's a foundation for this that I'm unaware of. 169 1 MS. ZETTLER: It's in evidence. 2 JUDGE POTTER: Let him finish. 3 MR. McGOLDRICK: Just because Ms. Zettler stands 4 up and says we did this, we did that, that's her testifying. 5 And maybe if there's some basis I'm not aware of for that, I 6 could stand corrected, but I don't know that she can get up 7 and say -- 8 MS. ZETTLER: I was trying to lead him along, 9 but this man has also been offered as an expert on spontaneous 10 reporting. 11 JUDGE POTTER: I haven't seen the thing that's 12 on the bulletin board. What is it? 13 MS. ZETTLER: It's the listing that Doctor 14 Breggin used using the numbers cumulative that we had run in 15 the spontaneous reporting system. 16 JUDGE POTTER: And that's a graphic 17 representation of his testimony? Then I think you have to 18 introduce it to him as this is what Doctor Breggin said, not 19 how you got it. 20 (BENCH DISCUSSION CONCLUDED) 21 Q. Doctor Tollefson, do you have an understanding 22 of what the reporting through 1639 forms is? 23 A. Somewhat, yes. 24 Q. Can you tell us what your understanding is what 25 you report through a 1639? 170 1 A. A 1639 would record a possible or actually 2 record a potential adverse event. It may or may not allude to 3 degree of certainty regarding the causality that was 4 encountered either postmarketed compound or during the context 5 of a clinical trial. 6 Q. Okay. In what context in a clinical trial would 7 an adverse event be reported with a 1639? 8 A. In a clinical trial, if an adverse event were 9 serious, for example, and unexpected, and possibly causally 10 related, under those criteria, it's reported on a 1639 within 11 a certain time frame to the agency. 12 Q. Okay. Now, is it your understanding that when 13 the FDA receives the 1639 reports on adverse events, they put 14 the data in these spontaneous reporting system? 15 A. Yes. 16 Q. Okay. In fact, you testified this morning that 17 Doctor Stodel, I believe, at the 1991 advisory committee 18 meeting testified about their database; correct? 19 A. Doctor Stodel. 20 MR. McGOLDRICK: I think that's a 21 mischaracterization of what was said this morning. I object. 22 JUDGE POTTER: He'll remember his own testimony. 23 Q. Doctor Stodel testified at the '91 PDAC meeting 24 about the spontaneous reporting system, didn't he? 25 A. That is true. I don't believe that we talked 171 1 specifically about him this morning. I think we did talk 2 about did the FDA make a presentation. Yes, the FDA did make 3 a presentation; he was one of their presenters. 4 Q. And the graphs that Mr. McGoldrick went through 5 with you this morning on the TV were hard copies of slides 6 that Doctor Stodel used in his testimony? 7 A. Yes. 8 Q. Okay. This poster board here is Doctor 9 Breggin's testimony with regards to the numbers of adverse 10 events that were reported in the spontaneous reporting system 11 to the FDA as of July of 1993. Okay? 12 A. Uh-huh. 13 Q. These reports I think you said earlier, 90 14 percent of them should have come from Lilly, approximately; 15 correct? 16 A. Yes. 17 Q. Okay. So let's get back to this. And this, 18 151, is a listing of spontaneous reports of adverse events 19 postmarketing, not clinical trial, just postmarketing, right, 20 as of December of 1992? 21 A. I mean, it is. Now, there is, I think, if I'm 22 not incorrect here, a significant difference between what you 23 have on the poster board and what you've given me here as an 24 exhibit. The exhibit is for worldwide patients exposed. 25 Those would be patients in any of the 72-plus countries where 172 1 Prozac is marketed. That data I'm assuming deals only with 2 spontaneous reports in the United States since this system is 3 an FDA system for collecting postmarketing events. 4 Q. Is it your testimony, Doctor Tollefson, that 5 Lilly is not required to report to the FDA adverse events that 6 occur with their drug outside the United States? 7 A. If they are -- this is my understanding. If 8 they are serious or unexpected, possibly causally related, 9 there is an immediate time frame for that; otherwise, it would 10 be done, if it is done, on an annual basis. But I'm not in 11 the regulatory science division so I probably would not be the 12 best person to give you that answer. 13 Q. So you're saying that the differences between 14 this document and that document that you have in your hand are 15 most easily explained by adverse events occurring outside the 16 United States that were not reported to the FDA? 17 A. I'm only raising the question which I can't 18 answer. This does say, the document I have here, "Estimated 19 worldwide exposures." I'm not sure on the timings and what is 20 captured on your board versus what is captured here. I'm 21 confused about that. 22 Q. You really don't know why there's a difference 23 between what is in the FDA's database and what's in Lilly's 24 database, do you? 25 A. I'm suggesting some possibilities why there 173 1 might be a discrepancy, but I don't know. 2 Q. One of the possibilities that you suggest is 3 that Lilly did not report to the FDA adverse events that 4 occurred on Prozac outside the United States? 5 A. Or I'm saying there may be a timing delay issue, 6 as we were discussing earlier. 7 Q. What's the usual time lag on reporting to the 8 FDA on suicide attempts? 9 A. If the suicide attempts were a serious event, it 10 would be reported within ten working days, typically. 11 Q. Okay. And if it's not serious, when should it 12 be reported? 13 A. It would typically go in an annual report, 14 once-a-year update. 15 Q. Overdose, I think we've covered already -- I 16 don't think we covered already. Can you tell us how many 17 overdoses were in Lilly's database in December of 1992, as 18 opposed to the FDA's database? 19 A. It says 1284 on this sheet. 20 Q. 1284 at Lilly; 894 at the FDA. Correct? 21 A. Yes. 22 Q. Okay. How about agitation? How many adverse 23 events of agitation were in Lilly's database in 1992? 24 A. Spontaneous figure listed here is 1571. 25 Q. Okay. So over 1500 adverse events of agitation 174 1 that Lilly was aware of in 1992, and 1,035 that were in the 2 spontaneous reporting system at the FDA as of 1993; correct? 3 A. It appears that way. 4 Q. How about hostility? 5 A. I have it. 6 Q. Pardon? 7 A. I have it. 8 Q. Okay. How many adverse events of hostility was 9 Lilly aware of in December of 1992? 10 A. It looks like there were 757 events that tracked 11 to that COSTART term hostility. 12 Q. Okay. And in July of 1993, the FDA had 664; 13 correct? 14 A. Yes. 15 Q. How about confusion, instances of confusion? 16 A. 761 on this document. 17 Q. So in December of 1992, Lilly was aware of 761 18 instances of confusion and the FDA had 492; correct? 19 A. Yes. 20 Q. How about thinking abnormal? 21 A. I believe it's 658. 22 Q. Okay. Again, in December of '92, Lilly was 23 aware of 658 events of thinking abnormal, and in July of 1993 24 the FDA had reported to them 497; correct? 25 A. Yes. 175 1 Q. How about insomnia? 2 A. 1363. 3 Q. Okay. And in 1993, the FDA was aware of 1,073; 4 correct? 5 A. Yes. 6 Q. How about manic reaction? 7 A. 645. 8 Q. And the FDA was aware in July of 1993 of 477; 9 correct? 10 A. That's what the chart says. 11 Q. Doctor, as a psychiatrist, are you aware that 12 certain behaviors present a risk for violent behavior? 13 A. I'm aware that there are certain behaviors that 14 are associated with violent behavior, but I believe violent 15 behavior in the professional estimation of most psychiatrists 16 is something that would be very difficult to predict. 17 Q. Okay. Can you tell us what types of behavior 18 are associated with violent behavior -- what types of 19 psychiatric conditions are associated with violent behavior? 20 A. Well, it might depend on the type of violent 21 behavior that you were interested in. There are what we would 22 call personality disorders that typically don't have a lot of 23 remorse or guilt about behaviors and will engage in a variety 24 of activities, criminal; it can be violent or nonviolent. 25 There are other groups of individuals that as part of their 176 1 illness may actually have a psychosis and part of their 2 delusional system may trigger in them a violent episode. And, 3 lastly, there are also groups of patients, Alzheimer's or 4 other disorders, where there is so much impairment of their 5 cognitive ability to assess their environment that if someone 6 were to come up to them they might potentially strike out, be 7 aggressive or be violent. Those are at least three of the 8 more common examples, I think. 9 Q. Would you agree that if somebody was suffering 10 from antisocial behavior they would present a higher risk of 11 violence than somebody who wasn't? 12 A. No, I wouldn't agree. Let me try to be better 13 in clarifying. When I talk about antisocial personality 14 disorder, I'd be talking about a clinical diagnosis 15 consistent, for example, with the DSM-III-R or the DSM-IV, a 16 diagnostic entity rather than an adverse-event term. 17 Q. How about hostility, would that present a higher 18 risk for violent behavior? 19 A. I think, you know, my gut reaction would be that 20 one would, you know, I think all of us might say that someone 21 who was hostile might be more likely to be violent but, to be 22 honest, I'm not aware of any clinical studies that have ever 23 drawn a close association between being hostile and in turn 24 being violent. 25 Q. The adverse event of intentional injury, that's 177 1 obviously some sort of an aggressive act, is it not? 2 A. It could be. 3 Q. These are adverse event terms that were used in 4 the reporting of adverse events on Prozac to the FDA; right? 5 A. That's correct. 6 Q. Ninety percent of which you said were probably 7 reported by Lilly itself; correct? 8 A. That's my understanding. Yes. 9 Q. Do you know what types of events or what types 10 of behavior map to intentional injury? 11 A. There are a variety. It could go from somebody 12 banging their hand on a wall in frustration to someone who did 13 a fairly significantly violent act toward another person. 14 Q. Like murder? 15 A. Yes. 16 Q. Or assault? 17 A. Yes. 18 Q. How about paranoid reaction? What types of 19 adverse events were reported under paranoid reaction, what 20 types of behavior? 21 A. Suspiciousness, fearfulness. 22 Q. Is paranoia a risk factor for violent behavior? 23 A. I think that from clinical experience someone 24 who is paranoid might be somewhat more overreactive, impulsive 25 on the moment but, in general, having a diagnosis of paranoia 178 1 doesn't increase one's likelihood to conduct a violent act. 2 Q. As a psychiatrist if you see somebody who is 3 paranoid, they are more likely to become violent impulsively 4 at least than somebody who is not paranoid; correct? 5 A. If they perceive that they have been threatened, 6 that is a possible outcome. 7 Q. And I think you've already talked about 8 delusions if they're paranoid could indicate a risk of violent 9 behavior? 10 A. Could if they're misinterpreting what's going on 11 around them. 12 Q. Well, that's a delusion, isn't it, Doctor? 13 A. A delusion is a false belief, a 14 misinterpretation. I'm trying to help clarify the term. 15 Q. How about mania or manic reaction, does that 16 present a higher risk factor for violent behavior? 17 A. In and of itself, no, but some patients who are 18 manic may either be delusional or they may be extremely unable 19 to control impulses. In that subset of manics they can 20 impulsively act out in an aggressive manner. 21 Q. How about schizophrenia or schizophrenic 22 reaction? 23 A. Schizophrenia is a disease, typically isn't 24 associated with a significant increase of risk of violence. 25 Q. What about schizophrenic reaction? 179 1 A. I don't believe that's ever been investigated 2 for that feature. 3 Q. What about psychosis? Does psychosis present a 4 risk factor for violent behavior? 5 A. Not in and of itself. I think it really gets 6 back to what we were discussing in the sense of the paranoia 7 and how an individual might be misinterpreting as part of the 8 delusion the environment around the individual that really 9 would dictate that more than an individual diagnostic term or 10 an event. 11 Q. What about personality disorder? 12 A. No. I don't think so. 13 Q. You don't think that that presents a risk factor 14 for violent behavior? 15 A. It depends on the types of personality 16 disorders. There are, in fact, as a diagnostic grouping nine 17 personality disorders. There are two in there that tend to 18 have a somewhat higher profile of being impulsive, one of them 19 I mentioned as being antisocial personality. 20 Q. You said you read Doctor Heiligenstein's 21 violent-aggressive behavior report; correct? 22 A. The manuscript? 23 Q. His manuscript on that. 24 A. Yes, ma'am. 25 Q. You discussed briefly at the PDAC in '91 the 180 1 results of his review; correct? 2 A. There was one slide in the review, yes. 3 Q. And I believe your testimony on that subject was 4 about a paragraph long, maybe three or four sentences; it was 5 very short, wasn't it? 6 A. A paragraph, I believe. 7 Q. Are you aware of how Doctor Heiligenstein did 8 his review of violent-aggressive behavior? 9 A. I'm not an author on the paper. I have a 10 general sense of what he did in that particular analysis, but 11 not being an author I don't have an in-depth analysis. 12 Q. Okay. Do you know that he ran things like 13 aggravation reaction, antisocial behavior, hostility, 14 irritability, paranoid reaction, psychotic depression, acute 15 brain syndrome, confusion, delirium, delusion, manic 16 depressive reaction, manic reaction, psychosis, schizophrenic 17 reaction, thinking abnormally, personality disorder, paranoid 18 reaction and depersonalization in the DEN database as the 19 first part of his review? 20 A. That wouldn't surprise me. I don't know for a 21 fact all of the terms that he did or didn't look at, but it 22 wouldn't surprise me if he had looked at those as a screening 23 technique. 24 Q. Do you know that after looking at the DEN 25 database, the spontaneous reports in the DEN database, that 181 1 wasn't included in his final manuscript, was it, an actual 2 review of the DEN database; correct? 3 A. Correct. 4 Q. If you look at his manuscript, it shows that 5 clinical trial data; correct? 6 A. Again, wanting to take advantage of the 7 placebo-controlled arm, he did focus on controlled clinical 8 trials. 9 Q. Okay. After running all of these through the 10 DEN database and getting numbers similar to these or similar 11 to these, he narrowed it down to three event terms in his 12 final paper; correct? 13 A. There were three categories. Under each of 14 those categories there were a whole series of event terms 15 of -- I think there were approximately, and if you have the 16 manuscript you could count them up, but I think there are 17 probably 30 or 40 event terms. 18 Q. Okay. Do you recall what any of those adverse 19 events were that he used? Let's do it this way. Do you 20 recall what the aggression cluster is? 21 A. The aggression cluster in Doctor Heiligenstein's 22 manuscript included events that trace up to the COSTART term 23 hostility, antisocial reaction and personality disorder; those 24 three categories. 25 Q. Okay. So we have hostility, antisocial behavior 182 1 and personality disorder; correct? 2 A. As categories, yes. 3 Q. None of these other adverse events as terms 4 themselves were run through the clinical trial database for 5 his review; correct? 6 A. Again, my understanding is he ran some 30 terms 7 under these categories. I don't know specifically which ones. 8 There were quite a few. 9 Q. Event term hostility in the COSTART dictionary 10 maps to hostility; does it not? 11 A. Hostility maps to hostility. There are several 12 other terms that map to hostility, as well; in fact, quite a 13 few. 14 Q. Well, all I see in here, Doctor, are four, I 15 believe. 16 A. There are eleven terms that map to hostility. 17 Q. In the COSTART dictionary? 18 A. Yes, ma'am. 19 Q. Would you find it for me? 20 A. I'm not familiar with what you've got open here. 21 Q. That's COSTART dictionary as of September 1989, 22 so if you'll find for me hostility where it maps to eleven 23 different adverse events. 24 A. No, I'm sorry. There are eleven events that map 25 or trace back to hostility, I believe. 183 1 Q. Okay. Find that for me. 2 MR. McGOLDRICK: If Your Honor please, we have a 3 list, if it will help. 4 JUDGE POTTER: That will be all right. 5 A. It would be quicker for me. 6 MR. McGOLDRICK: We have a copy of the paper 7 that's Exhibit 184. 8 A. Thanks. Would you like me to read the terms to 9 the jury? 10 Q. Why don't you tell me what's the first term. 11 A. Anger. 12 Q. Okay. Maps to hostility. 13 A. Aggression. 14 Q. Aggression isn't even an event term in here, 15 Doctor. Aggressive reaction, hostility. 16 A. Same thing. 17 Q. Go ahead. 18 A. Rage. 19 Q. Let's do it this way. How many of these map to 20 hostility? 21 A. (Reviews document) Personality disorder I 22 mentioned was -- is one of the three categories. 23 Q. But it doesn't map to hostility; right? That's 24 a separate category, that's a separate event term in and of 25 itself? 184 1 A. These are separate events. The ones on the 2 board do not map to hostility; that is correct. 3 Q. We know personality disorder is an event term in 4 and of itself; right? 5 A. Yes. 6 Q. We know antisocial behavior is an event term in 7 and of itself; correct? 8 A. Yes. 9 Q. And hostility; correct? 10 A. Uh-huh. 11 Q. Are any of those other event terms that were 12 originally run by Doctor Heiligenstein in his review mapped to 13 any of those three event terms? 14 A. I'm at somewhat of a disadvantage in that there 15 are 30 or 40 terms here. 16 Q. Take your time. 17 A. I apologize. It will take me a minute. 18 Q. Sure. 19 JUDGE POTTER: I'll tell you what. We'll go 20 ahead and -- have you got very much more, Ms. Zettler? 21 MS. ZETTLER: I have to check my notes, Judge, 22 but I don't think so. Maybe another half hour. 23 JUDGE POTTER: Okay. Well, we'll wait till 24 you're through and take the break. 25 A. I don't see anger on the board, which is one. I 185 1 don't see aggression on your board which is a term that maps 2 to hostility. 3 Q. Let's make sure we understand this. The reason 4 we chose these event terms and actually some of these -- some 5 of them switched, but like emotional lability, CNS stimulation 6 and agitation is that these are the event terms that were 7 originally run by Doctor Heiligenstein on the DEN database 8 before he did his final analysis on the clinical trial, and 9 what I want to know is where these fall into the three that he 10 finally picked to run through the clinical trial database. 11 A. Well, I think the ones that he picked, at least 12 as he says in his manuscript, were the ones where the profile 13 of the adverse-event terms suggested violent or aggressive 14 behavior, so I am presuming that these terms in his analysis 15 weren't terms that he felt were suggestive of violent or 16 aggressive behavior in and of themselves with the exception of 17 hostility, which is up there, personality disorder, which is 18 up there. 19 Q. Okay. Would you agree with me, Doctor, that in 20 the final analysis he did on the clinical trial database he 21 did not run all of these adverse event terms; he ran 22 personality disorder, hostility and antisocial behavior. 23 Correct? 24 A. It is correct but it does say in the paper that 25 he established a profile of adverse-event terms suggestive of 186 1 violent-aggressive behavior and then lists the some 30-odd 2 terms, such as rage and violence and violent behaviors and 3 antisocial reactions, et cetera, that are listed here. 4 Q. But he also testified in his deposition in 5 here -- at trial through his deposition that he ran these 6 through originally because he was concerned that they might 7 present a risk for violent behavior. Okay. Now, how about 8 intentional injury? Wouldn't you presume that somebody who 9 was intentionally injuring themselves or somebody else may 10 present a risk for violence? 11 A. I think that's a fair assumption. The problem 12 is that term was not even in COSTART until 1989, so much of 13 the data in Doctor Heiligenstein's database was information 14 collected prior to 1989, where that event term would not have 15 appeared. 16 Q. He did include data that occurred in 1989; 17 correct? 18 A. Right. But trials that are already under way 19 with a certain dictionary wouldn't likely be modified in 20 midstream, so I would suspect and it is a suspicion that 21 virtually all of the trials in here used the previous COSTART 22 dictionary which did not have the term intentional injury in 23 it. 24 MS. ZETTLER: Your Honor, this might be a good 25 time to take a break. I need to find something. 187 1 JUDGE POTTER: Ladies and gentlemen, we'll take 2 the afternoon recess. As I mentioned to you-all before, do 3 not permit anybody to give you any information about this 4 case; do not discuss it among yourselves or form or express 5 opinions. We'll take a 15-minute recess. 6 (RECESS) 7 SHERIFF CECIL: The jury is now entering. All 8 jurors are present, Court is back in session. 9 JUDGE POTTER: Doctor, I'll remind you you're 10 still under oath. 11 Ms. Zettler. 12 Q. Doctor Tollefson, generally, if the manufacturer 13 reports, you said in Lilly's case, about 90 percent of the 14 adverse events that are reported to the FDA, where would the 15 other 10 percent come from generally? 16 A. I think that it could come from a variety of 17 sources. It might come directly to the FDA from a physician. 18 It actually could be reported by someone who is not a health 19 care provider, as I understand the system, so it could be a 20 number of outside parties. Any member of the public, 21 professional or nonprofessional. 22 Q. Would you agree with me, Doctor Tollefson, that 23 the spontaneous reporting data is a predictor of trends that 24 may be occurring with a drug in adverse events? 25 A. Qualified agreement, that in some cases it could 188 1 be suggestive of a trend; in other cases, the system really 2 falls short of even being able to suggest trends. 3 Q. Okay. Would you agree that in cases where -- 4 let me show you a document. Would you agree that not only the 5 numbers of reports that are received by the FDA on drugs but 6 the differences between the drugs and reporting could signal a 7 problem with the drug generally? 8 A. Generally, I would disagree that it would, 9 because of the many reasons I cited this morning, some of them 10 I guess I didn't even get to. It could; in this case, it's my 11 opinion it does not. 12 Q. Okay. And in this particular exhibit, it shows 13 the differences in the rates between fluoxetine and trazodone; 14 correct? 15 A. Correct. 16 Q. Is it your understanding that trazodone came 17 onto the market in 1982? 18 A. I believe so. 19 Q. And this hostility and intentional injury; 20 correct? 21 A. Yes. 22 Q. And this chart was made by Doctor Stodel at the 23 FDA; correct? 24 A. Yes. 25 Q. Isn't it true that you agreed at the PDAC in 189 1 1991 that this type of information or the spontaneous 2 reporting type of information could indicate the need to study 3 an issue with regards to an adverse event? 4 A. Yes, it could. 5 Q. And, in fact, didn't you tell the PDAC that 6 because of the issue being raised of suicidality in the 7 clinical trial data or by the media, by Doctor Teicher, that 8 Lilly was in the process of beginning clinical trials on the 9 issue of suicidality and the use of Prozac? 10 A. Yes. I think what I recall is indicating that 11 there were different ways to assess this, case reports, 12 spontaneous event, controlled clinical trials and that we were 13 in the process of analyzing controlled clinical trials and 14 looking at additional trials that could be conducted 15 prospectively to provide more information. 16 Q. Isn't it true that you told PDAC in 1991 that a 17 clinical trial protocol had been initiated at that time on the 18 issue of suicide and its use of Prozac? 19 A. Yes. 20 Q. In fact, that wasn't true, was it, Doctor? 21 A. I believe it was true. The study that we've 22 talked about, for example, earlier, the agitation study that 23 used the ASIQ, was under way. 24 Q. You talked about at the PDAC doing a prospective 25 double-blind controlled study to look at the issue of 190 1 suicidality; correct? 2 A. Yes, ma'am. 3 Q. And you talked extensively before that, I 4 believe, about looking specifically at the issue of suicide 5 and the use of Prozac; did you not? 6 A. Yes. 7 Q. That study that you did on activation, its 8 primary objective was not to look at suicide and the use of 9 Prozac, was it, it was to look at the response of agitated 10 depressed people using Prozac; correct? 11 A. That is correct regarding the primary objective, 12 although, as you know, from that study one of the secondary 13 objectives was to determine whether the patient was agitated, 14 as part of their depression was at greater risk for adverse 15 events, including suicide, with one drug or the other. And we 16 looked at it, as you know, in two different ways with the 17 Hamilton and with the ASIQ. 18 Q. You also testified at the PDAC that one of the 19 prospective trials you were considering was a rechallenge 20 study; correct? 21 A. That was one of many. 22 Q. And I believe at that time you had submitted at 23 least two drafts of the rechallenge protocol to the FDA; 24 correct? 25 A. I'm not aware of that. That may have occurred 191 1 prior to my joining the company that protocols were submitted 2 to the FDA. I'm not aware of that. I can't tell you that it 3 went to the FDA. 4 Q. That study was never done, was it, Doctor? 5 A. The rechallenge study? 6 Q. Right. 7 A. No. We actually looked at a number of studies 8 that might address the question, trying to figure out which 9 one we thought might address the issue, some pros and a lot of 10 caveats in conducting that type of trial, and we felt that 11 compared to the other ways that we were going to be looking at 12 the data that there really wasn't a data. 13 Q. The answer to my question is no, the rechallenge 14 study was never done; correct? 15 A. That is correct. 16 Q. That's all I have, Your Honor. 17 JUDGE POTTER: Mr. McGoldrick. 18 MR. McGOLDRICK: Thank you, Your Honor. 19 20 EXAMINATION ___________ 21 22 BY_MR._McGOLDRICK: __ ___ ___________ 23 Q. Doctor Tollefson, let me just go over a few 24 things here. Doctor, first of all, I probably should have 25 left one of these back up. This -- had this document which is 192 1 something which I guess there's been testimony about Doctor 2 Breggin getting from the FDA and that was being compared by 3 Ms. Zettler with another document, which I guess is Exhibit 15 4 is which the jury has, and I just have a couple of questions 5 to you about that, Doctor. 6 A. Sure. 7 Q. First of all, in connection with the timing of 8 the filing of reports, does FDA have different rules for when 9 things are supposed to be reported? Some events are supposed 10 to be reported within 10 days or 15 days or in an annual 11 report? 12 MS. ZETTLER: Your Honor, I object to this as 13 leading. 14 JUDGE POTTER: Sustained. 15 Q. Do they have different time periods? 16 A. Yes, they do. 17 Q. And is this your primary field, knowing these 18 time periods? 19 A. No, it is not. 20 Q. But you know there are different time periods? 21 A. Yes. 22 Q. Now, when Lilly sends in a report of an adverse 23 event, whether it was causally related or not causally 24 related, does the FDA always take the same characterization 25 coding, so to speak, in computer terms, that Lilly uses or do 193 1 they sometimes recode? 2 MS. ZETTLER: Objection, leading. 3 JUDGE POTTER: Overruled. 4 Q. Go ahead. 5 A. I'm sorry. It's my understanding that they do 6 have that discretion to recategorize or recode. 7 Q. All right. Now, with respect to worldwide data 8 as opposed to domestic data, are there differences in how the 9 FDA has those reported and different time periods? 10 A. There is. 11 Q. Do you know what they are? 12 A. Typically, the company, as I understand it, 13 would prepare an annual report, that annual report would try 14 to include as many of the spontaneous events from the 15 worldwide experience as were available. Just given that we 16 are a U.S. based company, I'm suspecting that there would be a 17 little bit of a lag that, for example, it might be that we may 18 not have everything on December 31st from Lithuania that we 19 would have in the U.S., but essentially we try to have as much 20 as we can in an annual report. That report, of course, covers 21 an entire calendar year and that report is typically prepared 22 and reviewed and authenticated in February or early March of 23 the following year. 24 Q. And some of the -- strike that. 25 Is there a delay, as well, a timing delay, when 194 1 the FDA is taking its own spontaneous reporting and getting it 2 into its system? 3 A. Yes. 4 Q. Do you have any sense of that length of delay or 5 do you just not know that? 6 A. I don't know. One of the graphics we talked 7 about earlier suggested that there were some lags. I suspect 8 it takes them awhile. I don't know with their bureaucracy the 9 amount of days or months it might take. 10 Q. The details -- are you familiar with the details 11 of the reporting of either of these and the timing periods? 12 A. Well, I haven't -- I had not seen that poster 13 board, those numbers, ever before. As I tried to say, I may 14 not have done a good job earlier, this cuts off in July. We 15 typically would file an annual report for the preceding year 16 typically, as I understand it, in March sometime, first of 17 March, middle of March, something like that, and I don't know 18 how long it would take the FDA to take that volume and 19 incorporate it in their reporting system. If they would have 20 it in, for example, by this July cutoff or it might take them 21 four or six months and it may not appear till the September 22 cutoff. I was trying to get out a sense of timings that could 23 create some discrepancies in numbers. 24 Q. All right. As you sit here, you can't pinpoint 25 to the jury precisely why there are differences, if there are, 195 1 between these two, can you? 2 A. No, I cannot. 3 Q. But you pointed to those factors. Can you say 4 to the jury at least to some degree that this is an apple and 5 this is an orange? 6 MS. ZETTLER: Objection, Your Honor, leading. 7 JUDGE POTTER: Overruled. 8 A. I believe that in my earlier statement I 9 indicated I wasn't sure that these were really comparable 10 data. So in that sense if I'm understanding an apple and an 11 orange as being two different things, I would agree. 12 Q. Okay. Just keep that. Now, Doctor, I think you 13 spoke to us earlier about the studies that were done by folks 14 at Lilly to analyze the U.S. clinical trial database, and 15 Plaintiffs' counsel asked you some questions about that. Has 16 Lilly continued to keep up on the data with respect to these 17 items? 18 A. Yes, they have. 19 Q. Is the continuing information that you have 20 from -- consistent with or any different from the kind of data 21 you had before? 22 A. No, it isn't. 23 Q. No, it isn't what? 24 A. It's not different. 25 Q. Doctor, to your knowledge, has the FDA ever 196 1 found that Prozac is unsafe? 2 A. No. 3 Q. To your knowledge, has the FDA ever found that 4 Prozac causes suicides or violent behavior? 5 A. No, it hasn't. 6 Q. Thank you, Doctor. 7 JUDGE POTTER: Thank you very much, sir. You 8 may step down; you're excused. 9 Mr. McGoldrick, do you want to call your next 10 witness? 11 MR. McGOLDRICK: Yes, Your Honor. Mr. Stopher I 12 believe will do that. 13 MR. STOPHER: Your Honor, the deposition of 14 David Fewell. 15 JUDGE POTTER: Okay. Ladies and gentlemen, you 16 haven't had to have a deposition in a while, but even if you 17 would have had one recently, I would remind you that a 18 deposition is sworn testimony that's taken outside the 19 courtroom prior to trial. Each side is given an opportunity 20 to be present and examine and cross-examine the witness. When 21 the deposition is read to you at trial, you will give it the 22 same effect you would as if the person were here testifying 23 live. 24 (PORTIONS OF THE DEPOSITION OF DAVID FEWELL 25 WERE READ, THE QUESTIONS BY MR. EDWARD STOPHER 197 1 AND THE ANSWERS BY MR. ROBERT McCLURE, 2 AS FOLLOWS) 3 4 EXAMINATION ___________ 5 6 BY_MR._STOPHER: __ ___ _______ 7 Q. This is the deposition of David Fewell, taken on 8 May 4, 1993. Mr. Fewell was first duly sworn and then deposed 9 and testified as follows: 10 Would you state your name for us, please, sir. 11 A. David Fewell. 12 Q. And do you have a middle initial, sir? 13 A. B. 14 Q. And it's spelled F-E-W-E-L-L? 15 A. Yes. 16 Q. Where do you presently live, sir? 17 A. 835 Steele Road, Hernando, Mississippi. 18 MR. STOPHER: You need to speak into the two 19 microphones I think that are there on the stand. 20 Q. Steele? 21 A. S-T-E-E-L-E. 22 Q. What's the name of the town in Mississippi 23 again? 24 A. Hernando. 25 Q. Is it H-E-R -- 198 1 A. A-N-D-O, Hernando. 2 Q. Is it H-E-R-N-A-N-D-O? 3 A. It's Hernando. Well, it was named after 4 Hernando DeSoto, the Spanish explorer that came to this part 5 of the world several hundred years ago. 6 Q. The ZIP there, sir? 7 A. 38632. 8 Q. And your phone number, please? 9 A. 601-429-8627. 10 Q. And your age, please, sir? 11 A. Fifty-five. 12 Q. Date of birth? 13 A. 12-16-37. 14 Q. Social Security number? 15 A. 314-38-9788. 16 Q. Where do you presently work, sir? 17 A. At Quebecor Printing. 18 Q. And is that on East Holmes Road here in Memphis? 19 A. Yes. 20 Q. And what is your present job title there, sir? 21 A. Pressman. 22 Q. Where are you originally from, sir? 23 A. Jeffersonville. I grew up in Jeffersonville, 24 Indiana. 25 Q. Did you ever have any relatives that worked at 199 1 Standard Gravure? 2 A. No. 3 Q. Okay. You went to school in Jeffersonville? 4 A. Correct. 5 Q. And would it be Jeffersonville High, is that -- 6 A. That's correct. 7 Q. Did you graduate from there, sir? 8 A. Yes. 9 Q. And about what year? 10 A. 1957. 11 Q. What did you do after graduation? 12 A. Started work at Fawcett-Haynes Printing Company. 13 Q. And did you start there in 1957? 14 A. April. The first of April. 15 Q. And how long did you work there, sir? 16 A. I believe three weeks. 17 Q. Then what did you do, sir? 18 A. I went to work for Courier General. 19 Q. Did you start with The Courier as opposed to 20 Standard Gravure? 21 A. Yes. I worked for The Courier for eight years. 22 Q. And did you work in their pressroom? 23 A. That's where I became a journeyman, journeyman 24 pressman in the newspaper pressroom. 25 Q. So you were there from 1957 until approximately 200 1 1965; is that about right? 2 A. That's correct. 3 Q. And then what did you do? 4 A. I just quit one night and I went to work the 5 next -- well, anyway, -- actually, I worked one Saturday night 6 or one Friday night at The Courier and Sunday I started to 7 work at Standard. 8 Q. And that was in 1965; right? 9 A. Yes. 10 Q. And how long did you work at Standard? 11 A. Probably June of 1990. 12 Q. And what did you do after that, sir? 13 A. I went to work for Quebecor Printing. 14 Q. And you've been there ever since? 15 A. Correct. 16 Q. Now, sir, let me direct your attention back to 17 the 1950s, and let me start with the three weeks that you 18 worked at Fawcett-Haynes Printing Company, at least I think 19 that's what it was called in those days? 20 A. Yes. 21 Q. I would assume that you started there as a 22 fly-boy, am I correct? 23 A. That's correct. 24 Q. At the time that you worked there, did you know 25 Joseph Wesbecker? 201 1 A. No. 2 Q. In 1965, you started at Standard Gravure, and I 3 think you told me that you started there as a journeyman 4 pressman? 5 A. That's true. 6 Q. And continued, I assume, in that same position 7 until June of 1990 or thereabouts; correct? 8 A. Yes. That's true. 9 Q. Were you ever a foreman or a supervisor at any 10 time, sir? 11 A. No. 12 Q. You were a pressman working in the pressrooms? 13 A. I was assistant man in charge or -- several 14 times I'd run the press. I'd be on that capacity. 15 Q. Not a supervisor or a foreman; it's like being 16 second man in charge or first man in charge? 17 A. Well, it's in charge of a press, but, you know, 18 everybody has their duties to do, and it's not like you're 19 going around being a straw boss and delegating a lot of work. 20 Q. While you worked at Standard Gravure, did you 21 come to be acquainted with Joe Wesbecker? 22 A. Yes, I did. 23 Q. My understanding is, sir, he started there in 24 the summer of 1971. Did you know him before he started there? 25 A. No. 202 1 Q. During the 1970s, sir, did you have occasions to 2 work with him and to be around him at work on occasions? 3 A. Not that early, we became friends later. 4 Q. About when did you become friends? 5 A. It would have to be in after '81/'82. 6 Q. What event or what situation occurred that sort 7 of began the acquaintanceship that makes you fix that date? 8 A. Well, it was after my second divorce, and it was 9 about that time, I believe, that he got a divorce. He started 10 going to PWP, which is Parents Without Partners. It's for 11 divorced -- or it's an organization in Louisville that's for 12 parents with children that are not married. 13 Q. And is that how you came to be friends with him? 14 A. Well, actually, it's some guy you work with that 15 always seems to entertain, or he was the type of person that 16 he was looking for attention, I guess, because he would try to 17 entertain people in such a way that -- more lake a clown. 18 That's really what I remember about him to start with. 19 Q. Before your divorce and before his divorce, did 20 you know who he was at work? 21 A. I knew who he was a month after he started work, 22 a work-type relationship, but I didn't work the same shift he 23 worked, not until, like I say, later probably in the '80s, 24 where we started working the same shift. 25 Q. Okay. And was that the five-to-one shift? 203 1 A. No. That would be day work. 2 Q. Nine-to-five shift? 3 A. Yes. 4 Q. How did you and he get to be friends in 5 connection with Parents Without Partners? 6 A. Well, we was both single, and that was just a 7 good place to go and meet nice people. 8 Q. What would these events be like, sir? Was it a 9 social occasion with a bar and perhaps a band or music and 10 that sort of thing? 11 A. It started out with a meeting that a lot of 12 times they'd have speakers. If some of the women was having 13 problems, they may have a guess come in and maybe like an 14 attorney or a social work or maybe even a nurse or someone, 15 but they would -- after the meeting they would either turn on 16 a jukebox and open up a bar. The one on Shelbyville Road was 17 run by Zachary Taylor of the Veterans of Foreign Wars. 18 Q. Okay. What sort of involvement did Joe 19 Wesbecker have with Parents Without Partners? 20 A. To meet people. 21 Q. And did he meet some people at those meetings? 22 A. Yes. 23 Q. Do you recall who he met? 24 A. He met Brenda there, which is the woman that he 25 married, Brenda Beasley. 204 1 Q. Yes, sir. 2 A. He met her on Dixie Highway, that chapter of 3 PWP. 4 Q. Other than yourself, did he associate with 5 anybody else at those meetings, other males? 6 A. Yes. 7 Q. Who else was there that he associated with? 8 A. I remember Frank Wheatley, not Wheatley, Frank 9 Wheeler. There was a John -- a David John Wheeler. I believe 10 that's his name, David John Wheeler, which was -- they're 11 brothers. Let me bring this in. On Sundays they'd have a 12 volleyball meet where -- Parents Without Partners had a 13 volleyball team, and it was a social get-together for people 14 on Sunday, also, and I know he went several times and met a 15 lot of the volleyball players. 16 Q. Now, did he ever talk to you about Brenda's 17 former husband? 18 A. Quite often. 19 Q. What kinds of things would he say that you 20 remember about Doctor Beasley or Mr. Beasley? 21 A. Well, he thought Mr. Beasley was a shyster and 22 being that -- they would talk about that he would operate on 23 people's feature and not have the -- anyway, he told me that 24 Brenda told him that the hospital come calling up, that this 25 patient supposedly needed something done and he went -- well, 205 1 I think what he said was they was laying there bleeding or 2 whatever and needed some instructions on how to care for him 3 or whatever, and he never was around or whatever, that he was 4 the type of person that could sell an Eskimo a deep freeze. 5 You can go in there with your feature hurting and you'd end up 6 with a $1500 foot operation instead of putting corrective 7 shoes on and lose 10 or 15 pounds of weight, you know. And he 8 estimated that Mr. Beasley had to take in quite a bit of money 9 to make his expenses before he made any profit because he had 10 one practice in one of the medical buildings -- he had two 11 practices; one out on Dixie Highway and the other one in town 12 in the medical buildings. I think what he was trying -- or 13 what he said, you know, how many operations you have to make 14 before you pay the month's bills. 15 Q. Did Joe Wesbecker talk about how she was being 16 treated in the divorce by him? 17 A. Yeah. 18 Q. What did he have to say about that? 19 A. He went on to say that he wouldn't give her 20 child support. He wouldn't -- that he would hold back four or 21 five weeks ever child support and then give her some money 22 when she went to get her attorney. He just -- I think the 23 utilities were turned off. He was supposed to keep 24 maintenance up and he wasn't doing his -- what he agreed to 25 do. 206 1 Q. At that time, sir, in the 1981/'82 period when 2 you and he got to be friends, did he ever talk about work at 3 Standard Gravure and his relationships with his foreman and 4 the superintendent and so forth? 5 A. I -- he was like everybody else probably. He 6 said something from time to time about this guy or that guy or 7 he thinks he knows it all. But as far as -- the type of work 8 we do, the guy that's telling, the foreman or whatever, may or 9 may not know more than what you know; in other words, you're 10 assigned to run this press and produce books. If you're 11 having problems you may say, hey, I don't know what to do, you 12 know, or I've tried this and this and this, have you got any 13 suggestions. But to actually think of a foreman as being a 14 straw boss or somebody there cracking a whip or like the 15 Japanese way of production is, they put you on an assembly 16 line and they keep turning it up. When you can't handle any 17 more, you ring a bell, and then they come by and give you a 18 chewing for not keeping up. That's not the situation with 19 running a printing press. So, I'm not sure -- I just want to 20 kind of clear this or give you some idea of what it is to work 21 on a printing press and maybe help direct your questions in 22 that direction. 23 Q. In the early '80s, Joe and Brenda Wesbecker not 24 to seeing each other, I take it, fairly often? 25 A. I would say so. They got married. 207 1 Q. Did you go out with them frequently? 2 A. We met at -- we met -- what I mean is everybody 3 seemed to meet at Parents Without Partners or they'd have 4 dances, Valentine's, Thanksgiving, Christmas, New Year's, they 5 would have dances for the members. And from time to time we'd 6 meet at the dances. I have been out with them, but I can't 7 remember where we were or what we did or -- been in the same 8 crowd. 9 Q. Did you attend their wedding? 10 A. Yes. 11 Q. Where was it? 12 A. It's right outside of Jeffersonville at a 13 justice of the peace. 14 Q. And do you recall, sir, who else attended? 15 A. I think his name was Dailey. He married one of 16 the girls that Brenda worked with at the House of James. 17 Q. Joe's mother was not there? 18 A. No. 19 Q. Neither one of his sons were there? 20 A. I don't know. I don't remember. I don't 21 remember them being there. 22 Q. After they were married, sir, did you see Joe 23 Wesbecker outside of Standard Gravure? 24 A. The only time that I can remember being out with 25 him and Brenda is when they had a Christmas dance at Standard. 208 1 That had to be in the late '80s. The rest of the time they 2 were, I guess, doing like all newlyweds, getting their house 3 in order. I do know that they ended up living in Joe's house, 4 the one that he had before they were married, and it was 5 small, and he was having some problems with the children. 6 They ended up for some reason giving the children back to 7 Tommy. I have heard that he -- I don't -- I'm not sure what 8 all the reasons were. 9 Q. He was having problems with his stepchildren or 10 his own children? 11 A. Stepchildren. 12 Q. Did he ever tell you what the problems were? 13 A. Well, he said the girl was, I guess, defiant or 14 embarrassed living in such a small house with him, that it 15 seemed to be an embarrassment to her that he didn't drive a 16 Cadillac instead of an Oldsmobile and that type of situation. 17 Q. Did he ever tell you how he dealt with her? 18 A. He told me that -- what he told me was that if 19 she didn't like it there she could go live with her father, 20 but it wasn't quite -- evidently, there was a mutual dislike 21 there. 22 Q. Did Joe Wesbecker ever talk to you about either 23 one of his sons or any problems that he was having with them 24 or that they were having generally at that time? 25 A. I knew that he had -- his oldest son -- well, 209 1 let me go back. This doctor in Canada could straighten up his 2 spine by some kind of operation and he wanted to take the boy 3 and get this operation, and the boy was working at one of the 4 pizza places on Dixie Highway, and he had a girlfriend and was 5 content. I believe that's the way he was. And it got to the 6 point where -- I guess I'm -- the boy didn't want to, didn't 7 want any part of this operation or whatever and Joe felt that, 8 okay, if you don't want it, then -- or maybe the boy told him, 9 you know, leave me alone or whatever. It was kind of one of 10 those situations where they kind of separated. 11 Q. Did they have any relationship father to son 12 after that? 13 A. I don't know. 14 Q. Did you ever hear him talk about his older son 15 after that issue? 16 A. I don't know. I mean, the only thing was the 17 other boy is out selling pizzas or something and didn't want 18 any help or some kind of comment like that. 19 Q. What about the younger son? Did you ever hear 20 him discuss him? 21 A. The only -- he always bragged on his youngest 22 boy about how studious he was and what -- supposedly, I think 23 he got a scholarship to U of L or got a scholarship to finish 24 high school at Bishop David, which is a Catholic school in 25 Louisville, and that was kind of the only remarks, I believe, 210 1 I remember what he said about him. 2 Q. He never mentioned any problems with the younger 3 son? 4 A. No. 5 Q. At that period in time, sir, some people have 6 said that you were perhaps his closest friend. Do you know 7 anyone that was closer to him at that time? Obviously his 8 wife was, but outside of his family members, anybody that was 9 close to him other than you at that point? 10 A. Well, I know when he first started there and he 11 was on third shift or usually -- well, the time he started 12 there -- he had guys that he would joke around with, this 13 Charlie Miller, Charlie Ganote. I don't know if they ever did 14 any socializing together outside the place or not, but they 15 would cut up a lot. Wesbecker was the type of guy that would 16 draw a crowd when he first started there by his sexual feats 17 or tell a good sex story or something, and he was an 18 entertainer. I know one time that after we was in PWP that he 19 came in to work there telling about this pretty little blond 20 girl that he met out at PWP and what all he did later on that 21 night. And the guy asked me, he says, boy, them good-looking 22 blonds. I said, "Beauty is in the eye of the beholder." The 23 woman he was talking to sure wasn't no raving beauty, but 24 that's the type of person he was. 25 Q. Some of that bragging and drawing a crowd, did 211 1 that continue up through the time that you continued to know 2 him? 3 A. He had two changes that I can remember. The 4 first change was -- the first change is that he was always 5 giddy and being funny and like someone looking for attention, 6 I think. It seemed like he took a harder approach to things 7 when they were going to lay 50 people off from work and they 8 ended up hiring 30 off. That's at the time that he and Brenda 9 had gotten married, too, I believe, right in that time period. 10 It just seemed like he just got firm. Somehow the joking was 11 over with or -- and then the last part was that you didn't 12 want to be around him when you talked to him because he was 13 acting like he had tunnel vision, like he would be 14 somebody's -- he would be mad at somebody and he would just 15 change the subject and he would want to bring it back and just 16 dwell on it like it was eating on him. The last time that I 17 talked to him was -- he was working there in Area One and I 18 was working in Area Two, and at lunchtime I stopped by and he 19 was going to get -- I'm trying to think how he got -- for what 20 reason that they were letting him off from work. But I asked 21 him, I said, "What's the problem, Joe?" He said, "Well, I've 22 got this industrial" -- let's see. What the heck was it? My 23 mind has went blank. He didn't call it a disease, stressed -- 24 industrial stress is maybe what he said that -- I said, 25 "Industrial stress?" He said, yeah, he said, "It's when 212 1 people get stressed out and they can't perform at work." And 2 I thought, "Do I believe this?" He said, "Call me sometime." 3 He said, "I'll be at home. Call me sometimes and we'll talk." 4 Q. Did he ever discuss his relationship with Brenda 5 with you? 6 A. No. I knew that they had separated or whatever. 7 They had a Christmas dance, and I knew they were having some 8 problems but he never talked to me about it. 9 Q. Did he ever have any other girlfriends after he 10 married Brenda? 11 A. None that I knew of. He got -- before he quit 12 work, like I say, you really didn't try to be around him. You 13 know, it was -- he had this attitude. It was just like he 14 wanted to focus on whatever his attention was, and that was 15 it, someone you really wouldn't want to even start a 16 conversation with. 17 Q. At that time, sir, did he ever mention guns? 18 A. No. I never knew him really to be a gun person, 19 you know, like a hunter or a sportsman, even a weekend 20 shooter. 21 Q. Did you ever see him with any catalogues, 22 magazines or written material about guns or ammunition or 23 weaponry of some sort? 24 A. Not to my -- I don't -- no. I don't remember 25 any. 213 1 Q. At that point in time when people didn't want to 2 be around him, what sorts of things would he talk about 3 that -- I think you said he'd get real focused on -- 4 A. Focused on somebody. 5 Q. What would it be that he would be focused on? 6 A. Good point. I can't -- I can't really remember 7 exactly what because I wasn't interested, I guess. 8 Q. Was it someone or something? 9 A. I'm thinking it was probably people instead of 10 an event, like he might be mad at you or mad at him or 11 something like that maybe or maybe his ex-wife or -- not 12 Brenda but -- I don't remember her name. 13 Q. Sue? 14 A. Sue. I can't remember any particulars. 15 Q. At that time or at any time, sir, did you ever 16 hear him threaten anybody at Standard Gravure, say he wanted 17 to get even or do some harm to somebody? 18 A. It was never any it threats -- if there were any 19 threats, it was none that I took serious. But I -- to answer 20 your question, there's none that I can remember. You're 21 asking me a question and I just can't say that he did, but I'm 22 not saying that he didn't. 23 Q. Did you ever hear him talk about mental illness 24 or emotional difficulties? 25 A. The only thing that he was telling me was this 214 1 industrial emotional trauma thing that he couldn't perform his 2 duties at work or whatever it was because of this -- like I 3 said, supposedly he had he a name for it, and I thought he was 4 blowing smoke. 5 Q. During that last year, sir, how did he react and 6 get along with people that would tease him? 7 MS. ZETTLER: Where are you? 8 MR. STOPHER: Page 54. 9 MR. McCLURE: I've got page 46. 10 MR. STOPHER: Excuse me. I apologize. Page 46. 11 Q. Mr. Fewell, did he ever discuss with you at any 12 time his boyhood and his parents and where he grew up and how 13 he grew up, that sort of thing? 14 A. The only thing that I can recall, he was talking 15 about one time when he was 16, 17 maybe, that he got threw in 16 jail. I'm not sure what they were doing. They were going 17 over there fence to steal something or what it was, but they 18 got caught and they got threw in jail. 19 Q. During that last year, sir, how did he react and 20 get along with people that would tease him? 21 A. I don't -- I think he reacted in a hostile way, 22 hostile meaning the inner anger. I don't know that -- he, of 23 course, didn't have any fights other than verbal, and I don't 24 know that anybody in particular that was in a conflict with 25 him, you know, verbal or otherwise. 215 1 Q. Did people sort of stop teasing him or did they 2 continue teasing him as they had in the past? 3 A. I don't think that anybody intentionally teased 4 him or, you know, like two or three guys, "Well, we're going 5 to go over and beat up on Joe today." It wasn't that. This 6 is an older crowd, you know. Younger crowds would do that, 7 but these are guys are 40, 50 years old, and they have got 8 children and grandchildren and this and that. And the guy 9 wants to act a little weird, so to hell with him, you know. 10 Q. Did he have nicknames that people would use on 11 him? 12 A. He got two nicknames while I was there. One was 13 called Rocky and the other was called Sexbecker. Of course, 14 Sexbecker is a version of Wesbecker and, of course, always 15 bragging and everything about being a -- what word should I 16 use -- being a stud, I guess. And Rocky, he was down at Media 17 Mix with -- it was a part of the old YMCA that they converted 18 into a downtown athletic club, that Courier and Standard 19 formed a health club called the Media Mix, or they had -- they 20 had some kind of dealing in it through the Bingham Foundation 21 and he was -- one of the girl bartenders, now, whether he will 22 dated her or somebody else had dated her or whatever, and he 23 got in an argument with her -- I'm trying to think -- and one 24 of the WHAS news reporters or something butted in, and he just 25 told him to shut his lip or -- I don't know what he told him, 216 1 but they had a face-off. So they called him Rocky then 2 because he wanted to get up and duke it out and they give 3 him -- or that's the nickname. 4 JUDGE POTTER: Is this a different deponent? 5 MR. STOPHER: It is, Your Honor. 6 (PORTIONS OF THE DEPOSITION OF RICHARD 7 KEILMAN WERE READ, THE QUESTIONS BY 8 MR. EDWARD STOPHER AND THE ANSWERS BY 9 MR. ROBERT McCLURE, AS FOLLOWS) 10 11 EXAMINATION ___________ 12 13 BY_MR._STOPHER: __ ___ _______ 14 Q. This is the deposition of Richard Keilman, 15 May 4, 1993. Richard Keilman, after having been duly sworn 16 was deposed and testified as follows: 17 Would you state your name for us, please, sir? 18 A. Richard Scott Keilman. 19 Q. Where do you presently live, sir? 20 A. 6495 Rocky Park Drive, Memphis, Tennessee, 21 38141. 22 Q. And what is the telephone number there, sir? 23 A. 363-5996. 24 Q. Mr. Keilman, how old are you, sir? 25 A. Forty-two years old. 217 1 Q. And your date of birth, please? 2 A. 1-14-51. 3 Q. Social Security number? 4 A. 400-76-6331. 5 Q. And by whom are you presently employed, sir? 6 A. Quebecor. 7 Q. How do you spell that, sir? 8 A. Q-U-E-B-E-C-O-R. 9 Q. Is it one word? 10 A. Uh-huh. 11 Q. Is that a yes? 12 A. Yes. 13 Q. Q-U-E-B-E-C-O-R? 14 A. Yes, sir. 15 Q. And where is this located, sir? 16 A. 828 East Holmes Road. 17 Q. H-O-L-M-E-S? 18 A. Uh-huh. Yes, sir. 19 Q. And I take it that Quebecor is a printing 20 facility? 21 A. Yes. 22 Q. Is it a gravure-type printing company? 23 A. Yes. 24 Q. And what is your present title there, sir? 25 A. Pressman. 218 1 Q. Mr. Keilman, where are you originally from? 2 A. Louisville, Kentucky. 3 Q. Did you grow up there, sir? 4 A. Yes. 5 Q. Do you still have relatives in the Louisville 6 area? 7 A. Yes. 8 Q. Who are you still related to in that part? 9 A. My brother, my mother. My sister lives in 10 Leavenworth, Indiana. I've got aunts and uncles. My uncle 11 worked at Standard, also. And when they shut down, of course, 12 he decided -- he's retired now. 13 Q. Let me start with him. What was his name or 14 what is his name? 15 A. Kenneth, Kenneth Keilman. 16 Q. He worked there until -- 17 A. They shut the place down. 18 Q. Standard shut down in February of '92? 19 A. Yes. 20 Q. What was his job title there, sir? 21 A. He was a pressman. 22 Q. Where did you go to school, sir? 23 A. Fairdale High School. 24 Q. And did you graduate from there or what was the 25 highest grade? 219 1 A. Yes, I graduated. 2 Q. Graduated? 3 A. Yes. 4 Q. And what year was that, sir? 5 A. '69. 6 Q. After you graduated from Fairdale, what did you 7 do, sir? 8 A. I worked at a place called Universal Container 9 for a couple months until I got called to Standard Gravure. I 10 was promised a job at Standard when I was 15 by the 11 superintendent. He was a friend of my father's. 12 Q. And who was the superintendent? 13 A. Stan Hausman. 14 Q. And he was a friend of yours father's? 15 A. Uh-huh. Yes, sir. 16 Q. What was your father's name, sir? 17 A. Charles B. Keilman, Sr. 18 Q. And was he employed at -- 19 A. Yes, he was. 20 Q. -- Standard Gravure? 21 A. Yes. 22 Q. Was he a pressman? 23 A. Yes. 24 Q. About when did he die, sir? 25 A. Oh, man, I'm terrible with years and dates, 220 1 about '82 or thereabouts. 2 Q. And was he still employed at the time of his 3 death? 4 A. Yes, he was. 5 Q. Still working at Standard? 6 A. Yes. 7 Q. I take it he must have been relatively young, 8 perhaps in his mid to late fifties? 9 A. About 55. 10 Q. Mid fifties? 11 A. Yes. 12 Q. So, because of your dad's long term, I take it, 13 employment there, Mr. Hausman, who was the superintendent of 14 the pressroom, offered you a job when you were about 15 years 15 old? 16 A. Yeah. 17 Q. Now, sir, I take it in the fall or the latter 18 part of the 1969, you started at Standard Gravure? 19 A. It was July 5th. 20 Q. And how long did you work there, sir? 21 A. Almost 20 years. 22 Q. Until -- 23 A. Until after the fire, what was it, 19 -- was it 24 January of '88? 25 Q. No, sir. The fire was on November 10, 1988. 221 1 A. All right. At the end of '88, January of '89, 2 they released a bunch of us. 3 Q. In the period of time then, sir, from '69 to 4 early '89, I take it you worked in the pressroom all that 5 time? 6 A. Yes. 7 Q. Did you start as a fly-boy? Is that the way you 8 started, sir? 9 A. Yes, it is. 10 Q. And about how long was it until you became a 11 journeyman pressman? 12 A. Pretty close to ten years. 13 Q. So you were a fly-boy for ten years? 14 A. No. I was an apprentice for five years, too. 15 Q. So you were a fly-boy for five years? 16 A. I spent my service time in between there when I 17 went in the navy between fly-boy and apprentice, so I actually 18 spent about two and a half, three years as a fly-boy and then 19 I was in the service. I was on two years active duty. I come 20 back, got my apprenticeship and spent five years as an 21 apprentice or real close to it. 22 Q. Okay. Now, I take it as a fly-boy and as an 23 apprentice, you were also employed in the pressrooms; correct? 24 A. Right. 25 Q. Did you work in Area One or Area Two most of the 222 1 time? 2 A. As a fly-boy and apprentice, I probably spent 3 about an equal amount of time in each area. 4 Q. Switching back and forth? 5 A. Yes. 6 Q. And did you have any particular shift that you 7 worked as a fly-boy or as an apprentice? 8 A. After I come back out of the service, I said, "I 9 can't do this anymore." So I went on five in the afternoon to 10 one in the morning, and I worked mostly that, a little day 11 work in there. 12 Q. And the last ten years you were there, then you 13 were a journeyman pressman? 14 A. Yes, sir. 15 Q. When you were a pressman, sir, did you work in 16 Area One or usually in Area Two? 17 A. Area One. 18 Q. Area one? 19 A. (Nods head affirmatively). 20 Q. And was there one particular press that you 21 worked on in that area? 22 A. Well, I run Press One for quite a while. 23 Q. And would you be the man in charge or the second 24 man in charge? 25 A. I was second man in charge. 223 1 Q. And would that be on the five-to-one shift? 2 A. Yes. 3 Q. Let me see if I can get some more specifics. 4 Were you all aware of what Mr. Shea had done with regard to 5 the pension plan? 6 A. Yeah. 7 Q. Did you-all know that he had taken about five 8 million dollars in cash out of the pension plan and had put it 9 in junk bonds that cost him $500,000 approximately? 10 A. No. I didn't know that. 11 Q. What information did you-all have about what he 12 was doing to the pension plan, as you recall it, sir? 13 A. Well, I just understood that he come in and took 14 a bunch of money out of the pension plan because it was 15 overfunded, that -- it's not right, but it's legal. 16 Q. What was the attitude of the pressmen when 17 you-all learned that? 18 A. Well, probably mostly about like mine. I didn't 19 like it. There wasn't nothing I could do about it. It's 20 legal. The government says they can do it, so what can I say. 21 Q. When Shea came in, sir, did he attempt to speed 22 up the presses and to demand more quality in the production? 23 A. Somebody did. I don't know if it was Shea. I 24 would manage it was. 25 Q. How was it different in terms of speed and 224 1 quality requirements from what it had been under the Binghams? 2 A. I don't think it was all that much different 3 myself. 4 Q. Okay. 5 A. That's one of the reasons that when McKeown, 6 Bill McKeown, asked me to work -- to run a press was -- I just 7 figured that if there was anything that I could do to make a 8 differene, yeah, I'll do it. He used to come up and tell me 9 to slow my press down. 10 Q. McKeown did? 11 A. Yeah. 12 Q. I take it you were one of the better folder 13 operators? 14 A. I wouldn't necessarily say that. It's just I 15 like to see how fast they'd go and not fly part. 16 Q. Was there an issue with regard to Mr. Shea over 17 the termination of retirees' benefits, including medical and 18 hospitalization? 19 A. I really don't remember. 20 Q. After the service, sir, you came back, and I 21 take it at that time you started pretty much as an apprentice? 22 A. Right. 23 Q. And that would have been about '74? 24 A. '74, yes, sir. 25 Q. And then in 1979 you became a journeyman? 225 1 A. Right, or thereabouts. 2 Q. Okay, sir. When you were an apprentice, did you 3 have any contact with Joe Wesbecker? 4 A. I'm sure I did. I'm sure I had contact with 5 just about everybody in the pressroom, but I can't -- I didn't 6 have anything that would make a lasting impression, you know. 7 Q. Okay. As an apprentice in the mid to late '70s, 8 sir, did you ever recall working on a shift or a particular 9 job with him? 10 A. I probably worked with him some when he run a 11 reel in Area Two. That was the apprentice's job to help the 12 reel man. 13 Q. And would that have been on the one-to-nine 14 shift? 15 A. Well, probably. I believe he worked one to nine 16 at that time. 17 Q. I think at some point in time you told me you 18 worked the one-to-nine? 19 A. Yes, I did. When I first came back from the 20 service, I worked the nine-to-one for a while until I figured 21 out I couldn't do this no more. I got used to day work in the 22 navy. 23 Q. When you were an apprentice, what do you recall 24 about him and what his interests were and what was going on in 25 his life? 226 1 A. I don't recall anything because I didn't 2 really -- if I worked with him, you know, it just doesn't make 3 an impression on me how much I worked with him and where at. 4 Joe was a likable enough guy, you know. I just don't -- I 5 just, you know, don't remember sitting and having 6 conversations with him at that time. 7 Q. I take it that he was not a person that at that 8 time you were particularly close to; is that a fair statement? 9 A. That's right. 10 Q. At that time, sir, do you recall anybody that he 11 was particularly close to? 12 A. Maybe Johnny Tingle, David Fewell. Those are 13 two that come to mind. I can't think of anybody else. 14 Q. In 1979 or thereabouts, you become a journeyman? 15 A. Right. 16 Q. And I gather about that same time you started 17 working the five-to-one shift? 18 A. Right. Well, I started working that before -- 19 while I was an apprentice. 20 Q. Still an apprentice? 21 A. Yes. 22 Q. When you become a journeyman, are you working in 23 Area One or Area Two most of the time then? 24 A. I believe at that time I was on a proof press 25 and there was a proof press in each area, so I would bounce 227 1 back and forth. 2 Q. Do you have much contact at all with him during 3 that period of time? 4 A. No, sir; I don't believe so. 5 Q. He was still probably working the reel over in 6 Area Two? 7 A. I believe at that time he was on five to one and 8 probably up on the folder on the north line or the south line. 9 I don't remember which one. 10 Q. And that obviously would be in Area Two? 11 A. Yes. 12 Q. How did he like working the folder, if you know? 13 A. He didn't much care for it at all. 14 Q. What was -- 15 A. It was a job of responsibility. You was 16 responsible for what went up the conveyer to the bindery, and 17 apparently Joe just didn't care to be responsible. 18 Q. Did he ever talk to you about working the folder 19 and -- 20 A. I believe Joe talked to just about everybody in 21 the building about working the folder. 22 Q. Okay, sir. 23 A. I do remember that. 24 Q. Did he ever say in your hearing, whether it was 25 to you or somebody else and you happened to hear it, what his 228 1 problem was in working the folder? 2 A. Joe just didn't like -- he didn't like the 3 responsibility and he didn't like being told -- one thing that 4 does -- I do remember is if they come up and told him to speed 5 the press up, oh, God he'd get pissed. 6 Q. What would bother him about speeding up the 7 press? 8 A. Well, if you're running and you're running along 9 just fine, sometimes to speed up faster you'll have trouble 10 keeping the web in, and nobody likes to work, you know. 11 Q. You say have trouble keeping the web in. Are we 12 talking about a break in the web? 13 A. Yeah. 14 Q. If you speed the press up, sir, if you're 15 running slong and then you speed it up, if you don't break the 16 web do you sometimes get out of register? 17 A. Oh, you get out of register a little bit, yeah, 18 but it will come back. 19 Q. It will come back? 20 A. Or you can bring it back. That's what I say. 21 You have to work a little bit, but it will settle back down 22 and everything will just be hunky-dory. 23 Q. So you could speed it up when you were running 24 the folder? 25 A. Yeah. 229 1 Q. But, I take it, it bothered him to speed it up? 2 A. It bothered a lot of people. These guys I work 3 with down here, if the foreman comes up and says speed the 4 press up, they just go crazy. 5 Q. Is that because of a concern about a web break? 6 A. Yeah. 7 Q. When the web breaks, there's a lot of lost time 8 and there's a lot of extra work, am -- 9 A. If the sheet doesn't go out, the company makes 10 up a lot of times, you know. 11 Q. Did you ever hear Wesbecker talk about Cox? 12 Page 36. 13 MR. McCLURE: We still have a question on 34, 14 Ed, Line 23. 15 MR. STOPHER: I see. I apologize. Page 34. 16 Q. Did he ever say in your hearing that he thought 17 people were picking on him by making him work on the folder? 18 A. Yes, sir. He hated McKeown with a passion. He 19 hated Cox. Those were the main two. 20 Q. Did you ever hear Wesbecker talk about Cox? 21 A. I heard him talk about him and McKeown before, 22 yes. 23 Q. What kinds of things do you recall he said about 24 them? 25 A. Well, just that he hated them and thought they 230 1 was picking on him and like that. 2 Q. Were their other people, sir, that were working 3 on the folder that were having difficulty doing it and wanted 4 off? 5 A. Well, there was -- there was people that wanted 6 off, but Joe didn't have difficulty doing it. He was a good 7 folder plan as far as I knew. There was just -- guys would 8 get ticked off, you know, and they knew that they were hurting 9 for good folder men, and they would want off the folder just 10 to get a dig in, you know, just to hurt the company or 11 whatever. 12 Q. Were others let off of the folder? 13 A. I really don't remember. 14 Q. At that time, sir, in the early '80s, did you 15 ever have any information as to what was going on in Joe 16 Wesbecker's life? 17 A. I knew he divorced. And as a matter of fact, I 18 think him and David Fewell and my father would get together at 19 Parents Without Partners. I think that was the name of the 20 place. There was several guys up there that there divorced. 21 That's a disease amongst pressmen, I think. It comes from 22 drinking the water in the pressroom. 23 Q. Did you ever hear him talk about his attitude 24 generally toward management and the supervisors? 25 A The only thing I knew back then was that 231 1 he just -- he didn't like Cox or McKeown. He thought that he 2 was getting the screwing by having to work the folder. And up 3 until mid to late or late '80s, they finally -- he went on day 4 side and they put him -- he was on the reel on Press Three, 5 and it didn't get any better there. So, actually, anywhere 6 you put him he didn't like it? 7 Q. What was your relationship with Joe Wesbecker in 8 those days? 9 A. Well, there towards -- before the fire and 10 everything, he was off for a long time sick, and I'm talking 11 like -- the best I remember around '85 or so, he was on day 12 work. He was on the reel and I was on five to one, but I 13 worked a lot of overtime on day side. Usually if you work in 14 one area and you work overtime on another shift, they usually 15 keep you in the same area that you normally work in. So he 16 just -- I mean, he just didn't like it anywhere they put him. 17 You know, they put him on the reel to appease him, you know, 18 there wasn't much to it. He didn't have to leave the basement 19 much. I don't know what to say about the man. You couldn't 20 please him. 21 Q. Did he get along well and trust the other 22 pressmen? 23 A. Well, one of the guys he killed, Bill Ganote, 24 run the press that he was on the reel. And if Wesbecker 25 missed a paster, they'd always ride his butt something 232 1 terrible, and it was all in good nature but he would get hot. 2 So, for the most part, he got along with everybody, I guess. 3 I guess he felt like everybody was picking on him. You know, 4 most of it was just good-natured ribbing, you know. 5 Q. When he would get upset or mad or didn't take it 6 as a joke or as ribbing, how would he act? How would he show 7 it? 8 A. I'm trying to picture him now because he got mad 9 at me a couple of times. Joe was pretty small, and I'm 10 fairly -- he just stalked away from me a couple of times and 11 cussing me on his way out from wherever we was or whatever. 12 But it was the kind of a thing that didn't last, because I 13 liked to tease him, too, because pressmen seem to be a 14 different type of people. Once they see they get to you, then 15 they put the spurs on you and really dig in. And I'm no 16 different than anybody else, I guess. 17 Q. So I take it that he would react in a hostile or 18 an adverse manner to a teasing? 19 A. It would be worse. 20 Q. Then it would be increase? 21 A. Oh, yeah. 22 Q. In those days, sir, did he have any nicknames? 23 A. Sexbecker. That was from his exploits at 24 Parents Without Partners. Rocky, I don't know how he got that 25 one. I don't remember how. That's the best I can do. 233 1 Q. How did he react to being called those 2 nicknames? 3 A. I don't remember that it ever bothered him. 4 Q. You said sometimes like if he missed a paster, 5 what does that mean? 6 A. Well, when he was making a splice from one roll 7 to another and it would cause the sheet to go out, okay, and 8 then everybody would you tease him about, you know. 9 Q. And if they got on him about that, what would he 10 do? 11 A. He would get hot. 12 Q. When he got hot, what would he do? 13 A. He would cuss and raise hell. I mean, you know, 14 he didn't get physical or nothing like that, but he would rant 15 and rave pretty good. 16 Q. In those days, did he ever get physical with 17 anybody? 18 A. Not that I know. 19 Q. Did you hear him talk about fighting or trying 20 to fight? 21 A. He never talked to me about it. 22 Q. In those days did you ever hear him talk about 23 guns, firearms or weapons, that sort of thing? 24 A. Yeah. 25 Q. What did he have to say about those kinds of 234 1 things? 2 A I don't remember what he talked about. I 3 remember he had these magazines that -- and he talked -- he 4 would talk about guns, but I never did sit down and talk with 5 him about them because I don't know anything about guns 6 myself. 7 Q. Did anybody ever get disciplined or terminated 8 for bringing a gun in to work, to your knowledge? 9 A. So far as I know, they didn't. You had to shoot 10 the Pope to get fired from that place. 11 Q. What do you recall about it, sir? 12 A. He -- just that he wanted to shoot Popham. I 13 don't know. It was Popham. It was McKeown, it was, oh, hell, 14 Cox. It was -- you know, I never took him serious. I don't 15 think anybody did. Maybe if somebody had taken him more 16 serious, this wouldn't have happened. 17 Q. When he said that, sir, did you actually see a 18 pistol or a revolver? 19 A. No. 20 Q. Or a gun with him? 21 A. No. 22 Q. Where was he when he told you about this? 23 A. I think we were in the reel room. 24 Q. Who else was there, sir? 25 A. I don't remember. 235 1 Q. What specifically did he say as best you can 2 remember? 3 A. That's what I'm trying to think. 4 Q. Yes, sir. 5 A. It seems that he was mad at Popham for some 6 reason, and it was just, "If he comes down here I'm going to 7 shoot the son of a bitch," you know, something like that. 8 Q. Did he have anything with him at the time that 9 he made that statement? 10 A. Not that I know of. I didn't see no gun. I 11 saw -- I didn't see a gun. But, you know, it's like there was 12 a lot of people in there that carried guns to work, or you 13 knew they did or they said they did, you know. You didn't 14 actually see them. 15 Q. Mr. Keilman, did this occur when he was still 16 working there? 17 A. Yeah. 18 Q. Can you give us any idea as to what year or what 19 period we're talking about that he made that statement to you? 20 A. Mid '80s, as best I can -- the best I can 21 remember. 22 Q. I take it that you didn't believe that he was 23 serious from what you've told me? 24 A. No, I didn't. 25 Q. Did you report it to anybody? 236 1 A. I wouldn't know if I reported it to anybody. I 2 mean, sitting around talking, I might have said, you know, to 3 somebody that crazy Wesbecker, you heard what he come up with 4 now, you know, something like that. But, no, I didn't go 5 running to anybody and say, hey, watch your back, Joe was 6 going to kill you, because I didn't believe it. Joe went from 7 one of the nicest guys you'd ever want to meet to paranoid, 8 you know. Everybody was out to screw him, you know, and he 9 was just over -- you didn't realize it when it was happening. 10 But when you look back on it, you remember Joe the way he was 11 when, you know, in the '70s and whatever, and then the way he 12 ended up. I don't know what did it to him. 13 Q. What was different about him in the '70s as 14 compared to the times that you last saw him in the -- 15 A. He was just more happy-go-lucky. You know, he 16 was either divorced, getting divorced or whatever, and he 17 would talk about his conquests, you know, the ladies he put at 18 PWP and whatever. There towards the end, he was talking about 19 wanting to kill people and stuff, you know. I mean, wouldn't 20 you think there was a big change. 21 Q. During the time that you heard him make the 22 statement that he would kill the son of a bitch if he came 23 downstairs, were there others that told you that they had 24 heard things like that from him, also? 25 A. Not -- I don't remember at that time, just after 237 1 it happened, you know, you talk to people. And when it 2 happened, I didn't know -- I got a phone call that morning and 3 was told what had happened and I don't think Joe Wesbecker. 4 It was somebody else that worked there I thought it would be. 5 And then, you know, we talked down here, and I talked to 6 people up there, and then everybody starts remembering things 7 that Joe said that, you know, would lead you to believe that 8 this might happen, but not while we were working there. You 9 might have heard things, you know, but I don't remember. It 10 just didn't stick in my mind. 11 Q. I take it that after he stopped working at 12 Standard Gravure that you had some contact with him about a 13 car? 14 A. Yes, sir. He -- his boy had an Oldsmobile. I 15 don't remember what make, model, year or anything, but he blew 16 the motor up and Joe wanted me to rebuild the motor. But 17 after I pulled it out, it was a mess. It would have just been 18 cheaper to buy another motor and that's what he did. I put 19 the motor in. 20 Q. On the occasion that you dealt with him on that 21 vehicle, sir, did you talk with him or did he talk with you 22 about Standard Gravure and what his relationship was there? 23 A. I believe they said something about they was 24 cutting off his benefits or something. He was going to get a 25 lawyer or something. That's about it. We didn't talk much. 238 1 He was in a big hurry. They were going someplace. They were 2 all dressed up. I don't remember. 3 Q. Can you tell me when this was? 4 A. When was the fire? 5 Q. November 10, 1988, sir. 6 A. It may have been July or August. 7 Q. Of '88? 8 A. Of '88, yeah, or thereabouts. 9 Q. You moved from Louisville in January or the 10 early part of '89? 11 A. Right. 12 Q. At that time, sir, did he talk anything more 13 about Standard Gravure or about Cox or Popham or McKeown when 14 you did the work on the car? 15 A. No. 16 MR. STOPHER: Your Honor, this is a good place 17 to stop for the day. 18 JUDGE POTTER: Okay. Ladies and gentlemen, let 19 me just mention one thing. My sheriff said one of you had 20 mentioned something to her and I know a lot of you have 21 thoughts in your mind and things you're curious about and 22 there are probably a lot of things I know and I don't even 23 think to tell you-all, and some of you may be worried about 24 it. When the end of this case does come, you-all will not be 25 sequestered. Okay? You see that on TV that they put you in a 239 1 hotel room or something like that. In Kentucky, that does not 2 happen in -- well, there's certain criminal cases primarily. 3 It will not happen in this case. If you-all are deliberating 4 and have to go home, I'll give you the same admonition that 5 I've given you now and I'll send you home and come back in the 6 morning. If I trust you now, I'll trust you then. All right. 7 So maybe only one person was concerned about that, but I bet 8 that crossed at least more than one mind. No? Okay. 9 I'm going to give you the same admonition I've 10 given you before. Do not permit anybody to talk with you 11 about this case or communicate with you about this case and 12 that includes members of the public or members of the news 13 media. Do not discuss it among yourselves or form or ex[erss 14 opinions about it. We'll stand in recess till 9:00 tomorrow 15 morning. 16 (JURORS EXCUSED AT 4:30 P.M.; 17 HEARING IN CHAMBERS) 18 JUDGE POTTER: There was something left in Mr. 19 Shea. 20 MR. STOPHER: It was 131 to 134, Judge. 21 JUDGE POTTER: With leave to reconsider. All 22 right. So 131. All right. Let's see what Mr. Mattingly says 23 in his deposition. 24 MR. STOPHER: It begins down there, Judge, and 25 goes over to the next page. 240 1 JUDGE POTTER: There it is. 2 MS. ZETTLER: (Reviews document). 3 JUDGE POTTER: And in Kentucky if he doesn't say 4 it on the stand, he can then read him his deposition and it's 5 considered substantive evidence. 6 MS. ZETTLER: The way the question is posed to 7 Mr. Shea is that Paula Warman said the company wasn't going to 8 like it. That's the problem. 9 JUDGE POTTER: Okay. All right. Let me see. 10 Let's do it this way. I have reconsidered the ruling on Pages 11 131 through 134 and I'm going to overrule it with the 12 exception of 131, Line 25, and 132, Line 1. 13 MR. STOPHER: 131, Line 25. 14 JUDGE POTTER: It takes out the sentence, 15 "According to Mr. Mattingly, she responded that the company 16 didn't want to hear that." Mr. Mattingly does say that, but 17 it's in a different context, and since the gentleman said, "I 18 never heard any of it," I don't think it's that significant. 19 Just take out the sentence, "According to Mr. Mattingly, she 20 responded that the company did not want to hear that," because 21 that still says it wasn't reported. I read the thing he's 22 talking about the man not being capable of the job. Did 23 anybody ask him what he meant by that or not? We'll find out 24 when he gets here. Have we got enough where, Mr. Myers, 25 Ms. Zettler and I should see each other at 7:30 so we just 241 1 keep this train on the track? 2 MR. STOPHER: My understanding is, Judge, that 3 nobody is going to be doing this next week, so I've got to get 4 it cleared up as much as I can so I can get into the next week 5 and get it done. 6 MR. SMITH: Can I raise one issue now? I gave 7 you a list of witnesses that we got from Mr. Stopher at seven 8 last night. This is the original list that we got for this 9 week and this was sent November 14th, and Ed said he was going 10 to call these witnesses this week. So that's what we've been 11 relying on. Then last night we got a list of ten witnesses 12 that he said this is -- now, I thought that you kept that. I 13 left it -- Nancy may have picked it up. She has a habit of 14 picking up important stuff. 15 MS. ZETTLER: Just keep putting stuff like this 16 on the record. 17 MR. MYERS: I do not have one, Judge. 18 JUDGE POTTER: All right. Let me look out on 19 the desk. 20 (JUDGE POTTER LEAVES CHAMBERS) 21 MR. MYERS: The two that are left that I have 22 objections on are McCarty and Jackson. 23 MS. ZETTLER: Okay. 24 MR. STOPHER: We've got Rakow that's been out 25 since November 1st. 242 1 MS. ZETTLER: There's a motion on Rakow and it's 2 in his deposition. 3 MR. STOPHER: I haven't seen a motion. 4 MS. ZETTLER: It's oral. 5 MR. STOPHER: I haven't seen any objections to 6 Rakow, have I? 7 MS. ZETTLER: I don't think so. And the other 8 guy, you've got to get an excuse from his doctor, too. 9 MR. STOPHER: Yeah. Mr. Croft. I'm not sure 10 what his status is. He's been dealing with the Court 11 directly. 12 MS. ZETTLER: And the other guy, who was the 13 last one? 14 MR. STOPHER: Yeah. Oh, the guy with leukemia. 15 Okay. 16 MR. FOLEY: That's Vernon Rothenburger. 17 MS. ZETTLER: Just like Mr. Croft had a serious 18 heart condition, so we'll see when we get the proof. So 19 Jackson and McCarty are the only two then that we're in a 20 position to do anything with? I'm going to wait till the 21 Judge rules on that, Ed. 22 MR. MYERS: We made objections on Croft, Rakow 23 and Rotheburger. 24 MS. ZETTLER: Croft is coming in. 25 MR. STOPHER: We've got seven doctors. You can 243 1 strike Doctor Buchholz. I'm going to bring him in live. 2 MS. ZETTLER: What about Leventhal? Did you put 3 him on a list without deposition? 4 MR. STOPHER: I'd rather get the deposition 5 done, if I can get him here I can. I haven't been able to 6 reach him in the last two nights, so I don't know what that 7 means. So those doctors' depositions I want to deal with 8 early next week, so we need to get those done. They're 9 routine doctors' depositions. You were at half of them, Irv. 10 MS. ZETTLER: What do you mean you want to get 11 them done early next week? 12 MR. STOPHER: I mean the week after. 13 MS. ZETTLER: Okay. I ain't coming back down 14 here for depositions. 15 (JUDGE POTTER REENTERS CHAMBERS) 16 JUDGE POTTER: Your paralegal had a copy of it. 17 Is this what you're talking about? 18 MR. SMITH: Yeah. Apparently they have the 19 machine set up so the fax machine has the heading. This is 20 what we were relying on as going to be put on this week. Now 21 I've got this last night and Ed tells me that tomorrow he 22 wants to put on Jimmy Wesbecker and we were just first 23 notified of Jimmy Wesbecker last night. 24 JUDGE POTTER: Maybe I'm reading something into 25 what's been going on here that isn't there, but it does seem 244 1 like there has been an awful lot of confusion on what ought to 2 be a fairly straightforward kind of thing. Fewell went today; 3 right? Keilman went today; right? 4 MR. STOPHER: Uh-huh. Right. 5 JUDGE POTTER: What's wrong with Mattingly and 6 Minch tomorrow? 7 MR. STOPHER: I can do them both tomorrow, 8 Judge. My problem with Jimmy Wesbecker is that he's on home 9 incarceration and I've had to work to get a court order to get 10 him permitted to come here. 11 MR. SMITH: We've had no notice of that. 12 JUDGE POTTER: Wait. Wait. Wait. Wait. Wait. 13 MR. STOPHER: And then I've got a -- this Shea 14 deposition has not been done until just now and it's going to 15 take about six hours to get that edited and get it ready, so 16 I'm trying to fill in tomorrow. Mr. Croft is up in the air, 17 Judge, I don't know what the situation is on him. I'm leaving 18 that up to you and him. And I don't know whether he's got to 19 come live or what his situation is. 20 JUDGE POTTER: Between me and him right now he's 21 got to come live. I haven't communicated with him. As I view 22 it, you want to read a deposition, you've got to make the 23 necessary showing. And if you want me to get involved in 24 that, I will. 25 MR. STOPHER: I thought he had told us, Judge, 245 1 that he was going to talk to you. 2 JUDGE POTTER: No. He left some kind of message 3 with my clerk that she sent over that he had heart problems 4 and he couldn't come. 5 MR. STOPHER: I would prefer that he be here 6 live, so I'll just tell him that he's got to be here. 7 JUDGE POTTER: Okay. 8 MR. STOPHER: But the other problem that I've 9 had, it's difficult to anticipate. And I don't own any of 10 these people, these are all independent people. And I was 11 told yesterday that we'd start at 11:00 today, so I had people 12 here ready to go live at 11:00. And then at 3:00 I had to 13 tell them to go on and they're upset, so I'm trying to work 14 around the original schedule. 15 JUDGE POTTER: I understand. But this is 16 something -- you can have Minch and Mattingly here; right? 17 MR. STOPHER: I can have Mattingly and Minch 18 here. I will try to get the Shea deposition done, so we can 19 do it. 20 JUDGE POTTER: Call up -- who is doing it for 21 you? Ms. Cissell? Tell Ms. Cissell that we will owe her one. 22 All right? 23 MS. ZETTLER: She's done things overnight for us 24 constantly. 25 JUDGE POTTER: How about Mr. Ganote? 246 1 MR. STOPHER: He's unavailable now and I can't 2 get him here. 3 MR. SMITH: He's the brother-in-law of Linda. 4 JUDGE POTTER: So, Mr. Smith, to get right down 5 to it, we have Rex Rakow and we have to argue out -- I'm 6 two-thirds of the way through reading that. Do you still 7 intend to use Mr. Rakow? 8 MR. STOPHER: Yes, sir. 9 JUDGE POTTER: Have you marked the parts you 10 intend to use, because there's a whole lot of that that I 11 suspect that nobody wants. Have you marked the parts you 12 intend to use? 13 MR. STOPHER: Well, I think we designated the 14 whole thing, if I recall correctly. 15 JUDGE POTTER: If you did, you don't want to. 16 MR. STOPHER: We don't want to? All right. 17 JUDGE POTTER: I mean... All right. So, Mr. 18 Smith, in all fairness, if he gets Keilman, Minch and does -- 19 Minch and Mattingly and uses Shea, he has made a good-faith 20 effort to take his list in order. 21 MR. SMITH: Minch, Mattingly and Shea's 22 deposition? 23 JUDGE POTTER: I don't know if that will get us 24 through tomorrow, but that's -- you know, Ganote's a problem, 25 Wesbecker. Have you made arrangements to get Mr. Wesbecker 247 1 here? 2 MR. STOPHER: Yes, sir. He is to be here 3 tomorrow morning at 9:00. 4 JUDGE POTTER: Wait just a second, Mr. Smith. 5 Who else have you got off your second list? 6 MR. STOPHER: Well, for tomorrow, Judge, I can 7 bring in Rebecca Wade, who is the Louisville Water Company 8 lady, and that will take about five minutes, and John Henry. 9 JUDGE POTTER: Who is he? 10 MR. STOPHER: He's a repairman who did some work 11 when the water was shut off. I'd like to do Jimmy Wesbecker 12 in the morning, Dan Mattingly, then Ms. Minch and then the 13 Shea deposition, and then try to get these two people plugged 14 in at the end of the day; they're both short. 15 JUDGE POTTER: Has Mr. Wesbecker given his 16 deposition? 17 MR. STOPHER: He has, sir. 18 JUDGE POTTER: Mr. Smith, is there anything you 19 want to say why Wade and Henry are -- 20 MR. STOPHER: They're nothing. They're short. 21 MR. SMITH: Everything is okay except Jimmy 22 Wesbecker. I get this last night. I've already frankly gone 23 home with this stack of depositions after cross-examining a 24 witness all day yesterday, and we had no notice that Jimmy 25 Wesbecker was going to be here, you know. 248 1 JUDGE POTTER: But the point is he can go 2 through this list today and he's still got time tomorrow. He 3 can go through this list tomorrow and he's probably not going 4 to fill up a day, because I don't think Shea's more than a 5 couple hours and these people won't be that long. Maybe we're 6 overestimating. Who is Deidre Meredith? 7 MR. STOPHER: Neighbor, and very, very short. 8 JUDGE POTTER: How about Charles Conn? 9 MR. STOPHER: He is the gentleman we wanted to 10 bring up with you at some point who was in jail with Wesbecker 11 when they were youths. 12 JUDGE POTTER: You-all can't stipulate him out 13 somehow? 14 MR. STOPHER: I would hope so, but they won't 15 stipulate. 16 JUDGE POTTER: All right. We'll get him in 17 here. Who is Sam Vereena? 18 MR. STOPHER: He's the records librarian at Our 19 Lady of Peace. 20 JUDGE POTTER: Who is Barbara Sheehan? 21 MR. STOPHER: She is the records librarian at 22 Our Lady of Peace. It's a records librarian and I can't 23 remember where from. I'm drawing a blank on it. 24 JUDGE POTTER: Are Leventhal and Buchholz -- 25 MR. STOPHER: Buchholz will be here Friday 249 1 morning, Judge. 2 JUDGE POTTER: Okay. 3 MR. STOPHER: And Leventhal is in Florida and 4 I've not been able to make contact with him yet. It's 5 probably going to be after the break, if ever. I've 6 designated his deposition to be read in case I can't get him 7 up here. And I suspect that it will be the deposition because 8 he's quite elderly now. 9 JUDGE POTTER: Who, Leventhal? 10 MR. STOPHER: Yes, sir. He's been retired. 11 JUDGE POTTER: How long is his deposition? 12 MR. STOPHER: It's about 60 pages. 13 JUDGE POTTER: Is there any problem with 14 Leventhal's deposition? 15 MR. STOPHER: It's a straightforward doctor's 16 deposition. 17 MS. ZETTLER: I haven't had a chance to read it 18 yet. We just got this notice last night. 19 JUDGE POTTER: Mr. Smith, all theatrics aside -- 20 MR. SMITH: Me, theatrical? 21 JUDGE POTTER: -- is calling Mr. James Wesbecker 22 tomorrow you feel going to put you under any kind of -- 23 MR. SMITH: He's got a two-volume deposition. 24 Can we put him on Friday morning? 25 JUDGE POTTER: I tell you what, Mr. Stopher. 250 1 Where is -- he's on home incarceration? 2 MR. STOPHER: Right. 3 MR. SMITH: What does that mean? Does that mean 4 you had to get a court order to get him here? 5 MR. STOPHER: Grant Helman did it. I don't know 6 what the procedure is. 7 JUDGE POTTER: You get certain releases from 8 home incarceration to go to school and do this and you have to 9 get a judge to do that. 10 MR. SMITH: Is it a judge or can a sheriff do 11 it? 12 JUDGE POTTER: I'll fix it so he can be here 13 Friday morning. 14 MR. STOPHER: Judge, can I move then Doctor 15 Buchholz to tomorrow afternoon late? That's a short 16 deposition. 17 JUDGE POTTER: Okay. You can move Doctor 18 Buchholz and bring Mr. Leventhal's deposition with you early 19 in the morning, so if you need to read him for a while you 20 can. 21 MR. SMITH: Can we get a list of at least for 22 these next two days? 23 JUDGE POTTER: All right. Tomorrow you get 24 Mattingly and Minch live. You get Shea by deposition. That 25 gives you three hours, Mr. Smith, to go out and prepare. And 251 1 then live you may get a collection of these people, Rebecca 2 Wade, Henry, Vereena. 3 MR. STOPHER: I'll hold him out, Judge, since I 4 can't remember who he is. 5 JUDGE POTTER: All right. Barbara Sheehan and 6 then the two doctors, Leventhal and Buchholz. 7 MS. ZETTLER: Now, am I going to get an 8 opportunity to file objections to Leventhal's deposition? 9 JUDGE POTTER: How many pages is it, Mr. Myers? 10 MR. STOPHER: It's about 65 pages. 11 JUDGE POTTER: We'll just go over it first thing 12 in the morning. 13 MR. STOPHER: And we'll do Jimmy Wesbecker on 14 Friday and what's left over from the rest of that crowd. 15 MR. SMITH: Can I please ask a request that we 16 get these list of the witnesses a little quicker? 17 JUDGE POTTER: Let me go off the record. 18 (OFF THE RECORD; PROCEEDINGS TERMINATED 19 THIS DATE AT 5:00 P.M.) 20 21 22 23 24 25 252 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 253 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