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