838 1 IN THE UNITED STATES DISTRICT COURT 2 FOR THE DISTRICT OF HAWAII 3 4 SUSAN K. FORSYTH, ) Civil No. 95-00185ACK Individually and as ) 5 Personal Representative ) of the Estates of June M. ) Pages 838 - 1,029 6 Forsyth and William D. ) Forsyth, and WILLIAM F. ) 7 FORSYTH, JR., ) ) 8 Plaintiffs, ) ) 9 vs. ) ) 10 ELI LILLY AND COMPANY, ) an Indiana corporation, ) 11 et al., ) ) 12 Defendants. ) __________________________) 13 14 TRANSCRIPT OF PROCEEDINGS 15 The above-entitled matter came on for trial on 16 Thursday, March 11, 1999 at 9:30 a.m. at Honolulu, 17 Hawaii. 18 BEFORE: THE HONORABLE ALAN C. KAY 19 United States District Judge District of Hawaii 20 21 REPORTED BY: TINA M. STUHR, RPR, CSR #360 Notary Public, State of Hawaii 22 PACIFIC REPORTING SERVICES UNLIMITED, INC. 23 733 Bishop Street Suite 2090, Makai Tower 24 Honolulu, Hawaii 96813 (808) 524-PRSU 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 839 1 APPEARANCES: 2 For Plaintiffs: ANTHONY ANDERSON VICKERY, ESQ. Archer, Waldner & Vickery 3 2929 Allen Parkway Suite 2410 4 Houston, Texas 77019 5 KAREN BARTH, ESQ. Baum, Hedlund, Aristei, Guilford 6 & Downey 12100 Wilshire Boulevard 7 Suite 950 Los Angeles, California 90025 8 ROY K.S. CHANG, ESQ. 9 Shim & Chang 333 Queen Street 10 Suite 900 Honolulu, Hawaii 96813 11 For Defendant: ANDREW SEE, ESQ. 12 MICHELLE R. MANGRUM, ESQ. Shook, Hardy & Bacon L.L.P. 13 One Kansas City Place 1200 Main Street 14 Kansas City, Missouri 64105 15 EDMUND BURKE, ESQ. Burke Sakai McPheeters Bordner 16 Iwanaga & Estes 737 Bishop Street 17 Suite 3100 - Mauka Tower Honolulu, Hawaii 96813 18 Also Present: Catherine Itai 19 20 21 22 23 24 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 840 1 I N D E X 2 WITNESS ON BEHALF OF PLAINTIFFS 3 DAVID HEALY, M.D, Ph.D. PAGE 4 Direct Examination by Mr. Vickery 855 Cross-Examination by Mr. See 934 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 841 1 (Whereupon, the following proceedings were had 2 in open court out of the presence of the jury.) 3 THE CLERK: Civil No. 95-00185ACK, Susan K. 4 Forsyth, et al. versus Eli Lilly and Company, et al. 5 MR. VICKERY: Good morning, Your Honor. Andy 6 Vickery, Karen Barth, and Roy Chang for the 7 plaintiffs, the Forsyths. 8 THE COURT: Good morning. 9 MR. SEE: Good morning, Your Honor. Andy See, 10 Michelle Mangrum, and Ed Burke for Eli Lilly and 11 Company. 12 THE COURT: Good morning. Well, at five 13 minutes to nine the Court received this latest memo 14 from plaintiffs. Are you prepared to discuss that, 15 Mr. See? 16 MR. SEE: I certainly can, Your Honor. 17 THE COURT: Pardon me? 18 MR. SEE: I certainly can. Sure. 19 THE COURT: I guess we better let Mr. Vickery 20 go first. 21 MR. SEE: Yes, sir. 22 MR. VICKERY: First of all, I want to 23 apologize. I got it to the Court as fast as I could. 24 I was unaware until yesterday afternoon, of course, 25 that Mr. See was going to try to -- PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 842 1 THE COURT: I can't hear you. 2 MR. VICKERY: I said I want to apologize first 3 for laying this on the Court this morning. I think 4 we've, both sides, have imposed significant burdens on 5 the Court throughout, but I didn't realize until 6 yesterday afternoon that Mr. See was going to seek to 7 circumscribe Dr. Healy's testimony in the way that he 8 has. 9 The gist of the memo that we filed this 10 morning, Your Honor, was simply to point out to the 11 Court that the rules are to be construed and applied 12 in a way that does justice and that prevents a party 13 from having undue prejudice or unfair surprise, not, 14 on the other hand, as I think they are being urged in 15 this case, to support brinksmanship or one-upsmanship. 16 Eli Lilly can hardly claim it's unfair or 17 prejudicial to them to expect that witnesses called in 18 the trial would be asked about the ramifications of 19 exhibits, particularly their own documents, that have 20 been marked for ages to be admitted in this trial. 21 That's not unfair surprise. It's not prejudice, and 22 to the extent that those are relevant and germane to 23 the core opinions that have been previously disclosed, 24 deposed, and declarated at some length by an expert is 25 certainly not unfair prejudice or surprise. This is PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 843 1 particularly true, particularly true in view of the 2 fact that Lilly has deemed not to bring any of the 3 in-house scientists with that company that have the 4 expertise. So certainly not in my case in chief, as 5 we know, about Dr. Beasley, and I fear not in their 6 case in chief. I asked Mr. See this morning for the 7 line up of their witnesses next week so we can start 8 to prepare for them. He can't tell me or not whether 9 Dr. Tollefson will even come. 10 I suspect quite frankly, Your Honor, that 11 Mr. See's not going to bring anyone inhouse at Lilly 12 who's a scientist to answer the questions that we 13 think this jury is entitled to know. So, of course, 14 it places us at a significant unfair advantage if the 15 documentary evidence and the ramifications of the 16 documentary evidence cannot be explained by qualified 17 experts in the context of the opinions they previously 18 disclosed, and it was for that reason I filed this 19 memorandum this morning and cited the cases we did. 20 THE COURT: Thank you. Mr. See. 21 MR. SEE: Your Honor, first of all, I want to 22 correct a statement in Mr. Vickery's brief. I told 23 him about this before you came out, and I'm surprised 24 he didn't mention it to you. 25 MR. VICKERY: I should have. He's absolutely PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 844 1 right. He'll tell you. 2 MR. SEE: The case is -- the only piece of 3 evidence that Mr. Vickery has offered in this new 4 argument is that he says Dr. Healy's deposition -- 5 THE COURT: What page are you on? 6 MR. SEE: On Page 4. It's number two. He says 7 Dr. Healy's deposition put Lilly on notice that his 8 opinions that Lilly's warnings were inadequate and its 9 marketing was misleading. That's Mr. Vickery's 10 plaintiffs' claim and that part of Dr. Healy's 11 deposition that he has attached, I say to Your Honor, 12 has nothing whatever to do with that topic. 13 During Dr. Healy's deposition, he had reviewed 14 the expert report of Dr. Gary Tollefson, who not only 15 is on our witness list as a company witness, but was 16 identified by Lilly as an expert, both a company 17 witness and an expert. Dr. Healy reviewed 18 Dr. Tollefson's report, and I simply asked him, 19 anything in there that you disagree with? And with 20 respect to a particular passage where Dr. Tollefson 21 was talking about causation, Dr. Healy said that 22 statement made in Dr. Tollefson's expert report about 23 causation is misleading. 24 So any implication by the plaintiff that 25 Dr. Healy somehow gave an opinion at his deposition PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 845 1 about warnings or about marketing is, with respect, 2 simply false. That didn't happen. And the quotation 3 the plaintiffs have attached to this memo is not 4 supportive of what they say. It has nothing to do 5 with it. 6 With that cleared up, as I heard Mr. Vickery's 7 argument, none of it had anything to do with the issue 8 that the Court decided yesterday; that is, what 9 opinions were disclosed by Dr. Healy and that issue is 10 the same. Dr. Healy disclosed opinions on general 11 causation and on specific causation. He relied upon 12 no Lilly documents to form his opinions. 13 The declaration that he most recently filed 14 with the Court states that. I relied on no Lilly 15 documents to form my opinion. There was simply no 16 disclosure. I would be at risk of repeating my 17 argument of yesterday, but the simple matter is, 18 Dr. Healy did not disclose opinions on marketing, on 19 regulatory issues, on what Lilly should or should not 20 have submitted to the FDA or to the German regulatory 21 agency, none of that was disclosed. None of that was 22 questioned about. 23 Frankly, if Dr. Healy had said, you know, I've 24 read these Lilly documents and I've got some views on 25 them. I would have gone over line by line, what's PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 846 1 your view? What's wrong with it? How do you 2 criticize it? Why is it significant? I would have 3 done every bit of that, and I did none of it because 4 he disclosed nothing. 5 So I just want the Court to know that this 6 representation here is not correct, and the deposition 7 pages do not support it at all. That's very 8 misleading. 9 I think we've argued the issue and I think Your 10 Honor decided correctly yesterday. This witness -- 11 Mr. Vickery can use exhibits when they are appropriate 12 and when they are admissible with appropriate 13 witnesses, and I suspect that's going to come up, but 14 with this witness, it is not appropriate because he 15 did not opine on them, and did not disclose that he 16 was going to talk anything about them. So I think the 17 Judge's ruling yesterday was absolutely correct. 18 THE COURT: Well, the Court is not going to 19 change its ruling. The Court has read the plaintiffs' 20 brief and the cases cited and the Court finds that the 21 deposition did not put Lilly on fair notice of any 22 matters regarding marketing or notice or regulatory 23 matters. 24 The Court will limit him to what was contained 25 in his report as to what he was opining on. The Court PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 847 1 finds that otherwise Lilly would be prejudiced and 2 that this prejudice cannot be cured in the middle of 3 trial, and the Court further finds plaintiff clearly 4 should have sought to amend the expert report for 5 Dr. Healy. 6 Now, there's also this joint instruction you 7 wanted the Court to -- you wanted the Court to read 8 this morning, is that it, on these DER -- I guess what 9 you call DER, but they're really Drug Experienced 10 Reports and FDA spontaneous reporting system data. 11 MR. VICKERY: Mr. See wanted you to read it 12 this morning, Your Honor. I think it would be out of 13 context this morning. I think that at the appropriate 14 time that whenever those documents are on the floor 15 and being discussed, that it might be appropriate. I 16 think right now would not. 17 MR. SEE: I agree with that. I didn't know if 18 he was going to bring that issue up with Dr. Healy, 19 but when it comes up, then I believe the instruction 20 is appropriate. 21 THE COURT: All right. Then let the Court know 22 when you feel it is appropriate, and I'm not sure the 23 jury is going to understand what a Drug Experience 24 Report is unless you clearly explain that to the jury. 25 MR. VICKERY: If, as, and when we get to that PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 848 1 issue, Your Honor, we'll be glad to make sure that it 2 is put in a context they'll understand. 3 MR. SEE: I might say, Your Honor, the joint 4 submission of that instruction contains an initial 5 agreed upon portion. 6 THE COURT: Right. 7 MR. SEE: And then the plaintiff has asked for 8 an additional tail on the end to which we object. 9 THE COURT: The Court sees no need for the 10 additional portion that the plaintiffs seek. It seems 11 redundant and inappropriate. 12 Anything else we should take up at this time? 13 MR. VICKERY: No, Your Honor. 14 MR. SEE: Your Honor, while the jury is not 15 here, if it's convenient, it's very short. I would 16 hand up the report of Dr. Shlensky and raise the issue 17 similar to Dr. Healy, that when Dr. Shlensky comes to 18 the stand, he disclosed in his report and his 19 deposition opinions about two issues; one is 20 causation, and the other is the adequacy of Lilly's 21 warning. And that's it. 22 And my request would be that the Court make 23 similar ruling as the Court made with Dr. Healy, that 24 Dr. Shlensky can opine about those opinions which he 25 disclosed, but with respect to, for example, documents PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 849 1 submitted to Germany, documents submitted to the FDA 2 in the United States, Dr. Healy -- Dr. Shlensky, 3 pardon me, made no disclosure and no opinions about 4 those. 5 I might just add, so the record is clear, I 6 asked Dr. Shlensky, do you know anything about the 7 regulatory situation in Germany? Do you know about 8 the statutes and the regulations or anything about 9 that agency? And he said, nope. I'm not an expert in 10 that at all. That's at Pages 167 and 168 of his 11 deposition. 12 I said, well, what about foreign countries, do 13 you know anything about that, regulatory procedures 14 required in other foreign countries? No, I'm not an 15 expert in that. 16 THE COURT: Well, did you say he stated that he 17 did not know anything about the FDA regulatory process 18 or the BGA or both? 19 MR. SEE: The first that I've just said applies 20 to the BGA and any other foreign country. Now I will 21 tell you that on Pages 336 and Pages 497, Dr. Shlensky 22 testified that he was not knowledgeable about the 23 internal workings of the FDA, and he said, I'm not an 24 expert on what goes on at the FDA. 25 So that being the case, he having disclosed no PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 850 1 opinion about any issue on whether a regulatory 2 submission was appropriate, whether Lilly did the 3 right thing, or the wrong thing or whatever, there's 4 no opinion disclosed, and I asked him, do you know 5 anything about that and he said, no. 6 THE COURT: What pages did you say with respect 7 to the BGA and foreign regulatory? 8 MR. SEE: 167 and 168. 9 THE COURT: Do you have anything you wanted to 10 say on that Mr. Vickery? 11 MR. VICKERY: Your Honor, Mr. See just apprised 12 me 15 minutes ago about his concern in that regard 13 about Dr. Shlensky. I need to go look at 14 Dr. Shlensky's deposition at the pages he said. He's 15 not coming on today. He's coming on tomorrow. So I 16 will do that and be prepared to address it. 17 THE COURT: So that will be our bombshell for 18 tomorrow? 19 MR. VICKERY: Well, I promise not to lay any 20 paperwork bombshells on the Court tomorrow morning on 21 it. I think I understand the Court's -- the way that 22 you have interpreted it with regard to Dr. Healy, and 23 I'm certainly not going to ask you to do something 24 different with respect to Dr. Shlensky. 25 THE COURT: Well, are you both in agreement PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 851 1 with respect to the Court's earlier ruling that it is 2 not necessary to have a Daubert hearing as far as 3 Dr. Shlensky? 4 MR. VICKERY: I certainly am. 5 MR. SEE: Well, here's my issue on that, and it 6 was in the papers directed to Dr. Shlensky's opinion, 7 and it's this: I asked Dr. Shlensky, do you agree 8 that it is generally accepted in the medical and 9 scientific community that before you can find that a 10 drug causes an event, you must show a statistically 11 significant association between the drug and the 12 event? And Dr. Shlensky says, I think that's a fair 13 statement. 14 Now, having established by his testimony what 15 is generally accepted in the medical and scientific 16 community, I believe that unless Dr. Shlensky can come 17 up and say there is. Here is the study that shows a 18 statistically significant association between a 19 drug -- taking a drug and a bad event occurring, then 20 he ought not be able to testify under Daubert. 21 He himself has testified what the standard is, 22 and I don't believe that he's going to be able to come 23 up with the data that shows that, at least, we haven't 24 seen it. I have -- you know, I have the same kind of 25 objections to the rest of Dr. Shlensky's methodology PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 852 1 as I do to Dr. Healy's, and that has been in the 2 papers that have been on file with the Court; that is, 3 he relies to some extent on Jick. I think Jick does 4 not show a statistically significant association 5 between taking Prozac and suicide. He relies on Drug 6 Experience Reports and SRS, this Spontaneous Reporting 7 System data. I think the law is very clear that that 8 is black letter law, cannot be relied upon to support 9 a causal opinion. He relies on a bunch -- 10 THE COURT: Well, did you read that -- what was 11 it, the Medina case? 12 MR. VICKERY: Mendes-Silva. 13 THE COURT: Mendes case. 14 MR. SEE: I did not read it yesterday, Your 15 Honor. I have to admit that. So what Dr. Shlensky 16 comes down to relying upon is not consistent with the 17 standard that he himself admits is the generally 18 accepted standard in the medical and scientific 19 community to prove causation. 20 To that extent, his testimony is different than 21 Dr. Healy. Dr. Healy would not admit that, but 22 Dr. Shlensky did. To that extent, I think 23 Dr. Shlensky has admitted what the standard is and has 24 not, and I don't think can, come forward and show that 25 there is such data. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 853 1 THE COURT: Mr. Vickery. 2 MR. VICKERY: Dr. Shlensky, like any expert, 3 can testify in response to a hypothetical question. 4 He can be asked to assume that there is a 5 statistically significant or assume that causation is 6 established. I have read the Mendes-Silva case. I 7 read it at about 6:30 this morning, and clearly, any 8 expert can assume certain facts, to the extent that 9 that assumption is not satisfied in the minds of the 10 jury, that opinion is not well founded. That has 11 nothing to do whatsoever with Daubert. 12 This man is a clinician, and under a host of 13 cases, McKindle and Kennedy, to cite two, he may 14 testify. Now, if Mr. See -- I don't think he answered 15 the Court's question, does he want a Daubert hearing? 16 I don't think he answered that question. He said his 17 position is the same as Dr. Healy. If Mr. See wants a 18 Daubert hearing for Dr. Shlensky, I suggest, fine, 19 let's have at it. We'll bring him down here this 20 afternoon and when we're done with the jury, have a 21 Daubert hearing. I'll leave that between the Court 22 and Mr. See. I'm not in that fight. 23 MR. SEE: Your Honor, with respect to the 24 Daubert hearing, I did not mean to be non-responsive. 25 It's just that I believe that Dr. Shlensky, in his PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 854 1 testimony that's already been given and is before the 2 Court, has testified about what he admits the 3 generally accepted standard is. Now, if it would be 4 of assistance to have him come and I could put the 5 question to him again, you know, where are the 6 studies? Do you have the studies that show a 7 statistically significant association between Prozac 8 and suicide or homicide? Those questions can 9 absolutely be put to him, and perhaps they should be 10 put to him, but all I'm trying to say is when asked at 11 his deposition, there's no such data forthcoming. 12 THE COURT: Well, I'll rule on that later. 13 Mr. Vickery, you're on schedule for closing your case 14 tomorrow? 15 MR. VICKERY: I don't quite think so, Your 16 Honor. It depends on the length of the 17 cross-examination. I discussed it with Mr. See this 18 morning. I think we're going to get close to closing 19 tomorrow, but we may spill over into Tuesday. Just 20 depends on the cross. 21 THE COURT: And you both want me to or at 22 least, certainly Mr. See wants me to give that 23 instruction on the breast implant matter of yesterday? 24 MR. SEE: I do, Your Honor, if you will. 25 THE COURT: And I'll simply say that breast PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 855 1 implants have nothing to do with the issues before 2 this jury. 3 MR. SEE: I think that's fine. 4 THE COURT: All right. We'll take a few 5 minutes to let the jury come in. 6 (Whereupon, a recess was taken at 9:50 a.m.) 7 (Whereupon, the following proceedings were had 8 in open court in the presence of the jury.) 9 THE CLERK: Civil No. 95-00185ACK, Susan K. 10 Forsyth, et al. versus Eli Lilly and Company, et al. 11 MR. VICKERY: Good morning, Your Honor. Andy 12 Vickery, Roy Chang, and Karen Barth for the Forsyths. 13 THE COURT: Good morning. 14 MR. SEE: Good morning, Your Honor. Andy See, 15 Michelle Mangrum, and Ed Burke for Eli Lilly and 16 Company. 17 THE COURT: Good morning. Good morning, ladies 18 and gentlemen of the jury. We apologize again for the 19 delay, but we have been at work. I do want to 20 instruct you that breast implants have nothing to do 21 with this case. So just disregard that issue. 22 Mr. Vickery. 23 MR. VICKERY: Thank you, Your Honor. 24 FURTHER DIRECT EXAMINATION 25 BY MR. VICKERY: PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 856 1 Q. Good morning, Dr. Healy. 2 A. Good morning, Mr. Vickery. 3 Q. Take us back a step or two just to put it in 4 context. We had talked about challenge, dechallenge, 5 and rechallenge yesterday as the preferred method to 6 prove the causal relationship between a drug and an 7 event like akathisia or suicide and violence, right? 8 A. Yes. 9 Q. And then secondly, we were discussing 10 epidemiology as a means to determine the frequency 11 with which that happens? 12 A. Yes. 13 Q. And you were telling us about a study published 14 by Dr. Hershel Jick and Dr. Susan Jick and another 15 peron on this issue, correct? 16 A. Yes. 17 Q. And we were looking at some tables, and I'd 18 like to go back and just look very hastily at those 19 first two tables and just have you kind of put it in 20 context for us, and tell us the significance of this 21 table is this, and then we'll move on to number three, 22 okay? 23 A. All right. 24 Q. Ms. Barth, will you put number one on the 25 screen? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 857 1 A. Is it okay for me to go down? 2 THE COURT: Yes, you may. What table is this? 3 MR. VICKERY: This is table one, Your Honor. 4 THE WITNESS: This is not a Jick table. This 5 is a modified table from Table 3 of the Jick table. 6 We worked out the full figures. 7 MR. VICKERY: For the record, Your Honor, these 8 are the demonstrative aids marked as Plaintiffs' 9 Exhibit 161, which were slides prepared by Dr. Healy 10 from the figures in the Jick study to illustrate this 11 testimony. 12 THE COURT: Thank you. 13 MR. VICKERY: This is slide number one -- we'll 14 call it slide rather than table. 15 Q. Okay. Slide number one is entitled, "Method of 16 Suicide," and just very briefly what is the 17 significance of the fact that there are 189 per 18 100,000 patient years? 19 A. Well, the first point to get ahold of is the 20 figure for fluoxetine is higher than for all of the 21 other drugs. 22 THE COURT: You're going to have to speak up, 23 Dr. Healy, so the court reporter and the rest of us 24 can hear you also. In fact, maybe it would be better 25 if you had a mic. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 858 1 MR. VICKERY: I'll take this one, Your Honor. 2 THE WITNESS: The first point to note is that 3 the figure for fluoxetine is higher than for all of 4 the other antidepressants there. 5 Q (By Mr. Vickery) And you said fluoxetine. 6 A. Prozac. 7 Q. Prozac. 8 A. The next point that you want to note is the 9 reference antidepressant, the one to which all of the 10 other antidepressants are being compared is the 11 antidepressant on the first line there called 12 Dothiepin. And one more point to note is there are a 13 few other antidepressants here at the end which have 14 high figures also. Not as high as Prozac, but they 15 are high also. 16 Now, can we move on to the next table, please. 17 Q. Before we do, are these three licensed in the 18 United States, these three that have high figures? 19 A. Only one of them. 20 Q. Okay. Now, let's go to number two, slide 21 number two. And what was the significance of this 22 slide again? 23 THE COURT: What table is that a modification 24 of? 25 MR. VICKERY: The Judge wants to know what PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 859 1 table this modifies? 2 THE WITNESS: This is Table 3, I believe in the 3 Jick paper. This is the Odds Ratio Table, Your Honor. 4 The one that first gives the figure of 2.1. 5 Q (By Mr. Vickery) Dr. Healy, you just used a 6 term I think we need to define. Odds Ratio, is that 7 an epidemiological term? 8 A. Yes, it is. What we're talking about here is 9 the relative risk of the different antidepressants 10 which you've seen before in the previous table which 11 have now actually been converted into figures, so that 12 we can compare the relative risk of these agents. 13 Q. And is that a measure of what epidemiologists 14 call the strength of association between the drug and 15 an event? 16 A. It is, yes. 17 Q. All right. Now, let's move to the one that we 18 haven't seen, slide number three. 19 A. Well, I would have to hop back and forth 20 between three and two. 21 Q. If you'll just tell me, I'll use my pencil 22 here. 23 A. Could I have slide number two for a second in 24 my hand? Okay. Now, what Mr. See and what Eli Lilly 25 would want me to say to you that when -- PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 860 1 MR. SEE: Your Honor, may I just object to the 2 form of the testimony. 3 THE COURT: Sustained. 4 MR. SEE: And ask that we proceed by question 5 and answer. 6 THE WITNESS: Right. What scientifically we 7 would like to do is -- 8 THE COURT: Mr. Vickery. 9 MR. VICKERY: Yes, Your Honor. 10 Q. Would you explain for us what we are doing here 11 when we show the figures for adjusted relative risk in 12 the far right-hand column? Have you made some 13 adjustments? 14 A. These were made by Dr. Jick himself when he 15 actually compiled the paper. 16 Q. And punctuate this. 17 A. When he wrote the paper. 18 Q. What is the purpose for adjusting the relative 19 risk and putting this information in a table for 20 scientists, such as yourself, to read in a published 21 journal? 22 A. The purpose is this: What you've seen in the 23 previous table is the fact that Prozac was 2.1 times 24 more likely, it seemed, to be associated with people 25 committing suicide than the reference antidepressant. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 861 1 Now, what we don't know from that is whether the 2 problem is being caused by Prozac or whether there's 3 something about the people to whom it's being given 4 that makes them more likely to actually commit 5 suicide. 6 So what you would ideally like to do is to 7 remove from the equation the people who we know who 8 are at highest risk of actually committing suicide for 9 other reasons. Men are more likely to commit suicide 10 than women. The older you are, the more likely you 11 are to commit suicide. If you've tried to commit 12 suicide before, this makes you much more likely to try 13 again. 14 Now, when you control for all of these things, 15 when you remove all of these people from the previous 16 table that you've seen, what Dr. Jick here has done is 17 to estimate a new relative risk for all of the 18 antidepressants that you saw beforehand, and this will 19 be for a group of people who, on average, are going to 20 be younger, probably less men in the group, and 21 certainly it will have removed from the group the 22 people who've tried to commit suicide before. 23 So you've got people who are depressed, who are 24 out of work, and you can perhaps begin to make an 25 estimate, could it be the illness or could it be PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 862 1 something to do with the pill they're on that's 2 actually causing the problem. 3 Q. So let's -- we may hear this term later, so 4 help us out. Those things that you removed, that 5 we're not going to sort of talk about, are those 6 called confounding factors? 7 A. They are called confounding factors. And I'll 8 add here further, Dr. Jick has removed some of the 9 confounding factors, not all. 10 Q. What confounding factor has he not removed that 11 would be significant? 12 A. Well, one of the things that won't come out of 13 this particular table at all is the fact that one of 14 the antidepressants, the one that's up here on the 15 top, the one regarding which they did all the work, 16 Dothiepin is an antidepressant which, when you take it 17 in overdose, you're highly likely to kill yourself. 18 Prozac on the other hand, if you overdose on it, you 19 won't kill yourself. Now, this is a significant 20 confounding factor that hasn't been controlled for at 21 all in this table. 22 Q. And if -- 23 A. The other thing that hasn't -- 24 Q. Before we leave that, if one were to, is there 25 a way to predict what effect it would have if we PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 863 1 adjusted for that confounding factor? In other words, 2 if we removed that group of people who had tried 3 before from the list. 4 A. I think there is, but I haven't tried to do 5 that. Actually, you'll see, I think there are other 6 ways to actually handle the issues as you'll see later 7 on. 8 Q. Okay. So explain for us, then, once they are 9 adjusted for the confounding factors in the far 10 right-hand column of slide three here, we still see 11 the 2.1, correct? 12 A. Let me take you through this, Mr. Vickery. 13 Yes, we do see the 2.1, but I want to point out a few 14 more features of the actual table. 15 Q. Okay. What's significant about the table? 16 Tell us about that. 17 A. Well, there were a few of the antidepressants 18 that you saw on the previous table which are ones that 19 you cannot kill yourself when you overdose with them, 20 okay, so you might think that general practitioners, 21 when they are faced with a person who they know to be 22 at risk for suicide, would opt an antidepressant 23 that's less likely to kill the person if they take an 24 overdose. 25 Now, the three antidepressants you saw at the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 864 1 end, which also had very high figures, which were 2 Trazodone and Mianserin and Flupenthixol, the figures 3 you had on the previous table, you have to -- I'll 4 read these out for you. When we didn't control for 5 the risks, the figures for Mianserin were 1.8. 6 Q. Ms. Barth, could you just write that down? 7 A. Yes, just beside the last line, 1.8. That was 8 the figure. So when we take out all the people who 9 might have been higher risk whom GPs may have been 10 giving Mianserin to because it's safe in overdose, 11 when we take those out of the equation, and just look 12 at the people who are at lower risk who got this drug, 13 they see much less likely now to commit suicide. 14 Q. There -- 15 A. The relative risk has fallen from 1.8 to 1.1. 16 Q. All right. 17 A. Now, if you look at the next antidepressant on 18 the list and the order has altered slightly. 19 Trazodone has gone off that list, for whatever reason. 20 Flupenthixol is the one that's next on your list there 21 and you see 0.9. That was 1.3, so again, this is a 22 drug which you cannot kill yourself with an overdose, 23 and the fact that the relative risk has dropped, 24 strongly implies that GPs were giving this to people 25 who were at risk, and the reason why you had the high PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 865 1 figure the last time for it was because it was being 2 used for people who were at risk, okay. 3 The same is true for all of the other 4 antidepressants on that table. If you were to compare 5 the previous table with this table, in every case, the 6 figure falls. The risk falls in this group of people, 7 except for one drug, fluoxetine. 8 Q. Prozac? 9 A. Prozac, where it stays exactly the same, 2.1. 10 Q. Okay. Now, Dr. Healy, I see here that the 11 confidence interval, if that's what this information 12 in parentheses is, has also changed once we make that 13 adjustment; is that true? 14 A. That is true, Mr. Vickery. 15 Q. What is the significance of the change in the 16 range of the confidence interval? 17 A. The significance is two or three-fold. First 18 of all, in order to control in this way, to take out 19 the people who are of higher risk and to make sure 20 that it's not the risk that they bring to the 21 situation that's seeming to cause the problem, all 22 right, if you remove all of those from the study, 23 you're left with much fewer people, and the confidence 24 interval necessarily broadens out. You can't be as 25 absolutely sure what the true value is. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 866 1 Q. Let me stop and ask you a question about that. 2 We've talked about, in different context, proving 3 something, proving causation scientifically with just 4 one person. Is it important when we're looking at 5 epidemiology, to have large populations of people and 6 if so, why? 7 A. It is extremely important to have large 8 populations. Suicide is a very rare event, and unless 9 you have extremely large populations, you're not going 10 to be able to tell the difference between the 11 different drugs. 12 Q. Okay. 13 A. Now, what the confidence interval there says to 14 you is this: That if you have money to bet, you 15 should bet on the figure of 2.1 being the true figure. 16 It is entirely possible that 0.6 is the true figure, 17 in which case Prozac would be okay, but what it also 18 says to you, if anyone from Eli Lilly were here in the 19 room, they could not reassure you that 7.9 isn't the 20 true figure. That Prozac is 7.9 times more likely to 21 be associated with people committing suicide than this 22 other antidepressant Dothiepin. 23 Q. Dr. Healy, can you explain to us why the 2.1 24 number is not smack dab in the middle of the 25 confidence interval and what significance is it that PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 867 1 the 2.1 figure is on the lower end of the confidence 2 level? Can you explain that for us? 3 A. It's not easily explained, Mr. Vickery. No, 4 that's just the way the cards fall. If you have a 5 figure of 2.1 you obviously can't go down below zero. 6 You'll see, however, it's awfully interesting the one 7 antidepressant there that does not act on the 8 serotonin system at all that I pointed out to you 9 yesterday, the third line there, a drug called 10 Lofepramine, it gets down as close to zero as you can 11 possibly get. They have said, look, this is 12 associated with suicide. The true figure could well 13 be zero. That's what they're saying, but you couldn't 14 get lower than that. 15 So, in essence, if the figure is 2.1, in 16 general, there's going to be more figures on the 17 right-hand side of that than on the left, and what 18 you'd be looking for is any other evidence from the 19 real world that led you to believe that the true 20 figure might err from 2.1, either to the right or to 21 the left, and we believe that there is a considerable 22 amount of evidence that suggests that the true figure, 23 if it isn't 2.1, lies between 2.1 and 7.9 rather than 24 between 2.1 and 0.6. 25 Q. Okay. If you will take your seat again then, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 868 1 we will talk about that evidence. How many patients 2 were involved in the Jick study? 3 A. It was over 172,000 patients. 4 Q. And from what population of patients were these 5 patients taken? 6 A. This was done over in the U.K., the United 7 Kingdom, in what is called primary care. These are 8 people who are mildly to moderately depressed who are 9 going to their primary care physician for treatment. 10 They were not going to a psychiatrist. 11 Q. Is there information that's useful for 12 epidemiological purposes from this same population of 13 people on this same database in the U.K. that will put 14 these Jick figures in perspective? 15 A. There is, Mr. Vickery. 16 Q. And have you studied and written about and 17 published about those patients and the significance of 18 them? 19 A. Yes, I have. 20 Q. Tell us, if you would, what studies have been 21 published or currently in publication by yourself or 22 others that bear on these issues. 23 A. Right. In a journal called Psychological 24 Medicine This Year, which is probably the premiere 25 U.K, if not European journal of psychiatry, an article PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 869 1 appeared in the first issue looking at all of the 2 suicides in an area of England called North 3 Staffordshire. This is an area that's colloquially 4 called the Black Country. It's the opposite to the 5 Rainbow State. It's not where you would like to live 6 probably. But it's entirely representative of the 7 rest of the United Kingdom in that they have exactly 8 the same rates of suicide as all of the United 9 Kingdom, and the same things that we know to be 10 associated with suicide in the rest of the United 11 Kingdom are associated with suicide in the same ratio 12 in this area. 13 This area is an area of over 470,000 people and 14 one of my colleagues, Dr. Boardman, did a piece of 15 work that lasted the better part of six to seven 16 years. He collected data for five years on these 17 470,971 people, giving altogether, almost two and a 18 half million patient years as we would refer to it, 19 and out of this he was able to find 212 people who'd 20 committed suicide. 21 Q. 212 out of how many patient years? 22 A. Two and a half million. 23 Q. All right. And does that tell us something 24 about -- are these depressed people on antidepressants 25 or are these just the full range of everybody? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 870 1 A. He looked at everybody who had actually 2 committed suicide for any reason, and he then went 3 back to look at whether they were known to be 4 depressed, whether they had been known to have an 5 alcohol problem, known to have schizophrenia or 6 whatever. 7 Q. Okay, sir. Now, did you take that work done by 8 Dr. Boardman over these six or seven years and work 9 personally with Dr. Boardman to carry that to the next 10 step that provides us with helpful information? 11 A. Yes, I have done, Mr. Vickery. 12 Q. And tell us what it is that you have done in 13 that regard. 14 A. What we have done is we have gone back to the 15 data and looked at what the rates of suicide in 16 primary care in the United Kingdom should be; that is, 17 for people who are depressed, who are only seeing 18 their general physician, who have not gone on to see a 19 psychiatrist. We've also been able to estimate the 20 rates of suicide for people who have gone on to see a 21 psychiatrist, who have obviously been more severely 22 depressed, and we have the figures here for you today. 23 Q. And have you prepared those in a written 24 publication that is being submitted for peer review 25 and publication within the next few weeks or months? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 871 1 A. Yes, I have, Mr. Vickery. 2 Q. Tell us, if you will, and I'll write it on the 3 board here. Let's give credit where credit is due. 4 Are you the senior author on this one or is it 5 Dr. Boardman? 6 A. Dr. Boardman is the senior author, in that he's 7 the person who's been actually responsible for making 8 sure that we have the data in the first instance. 9 Q. Okay. And according to the Boardman/Healy 10 analysis of this epidemiological data, what is the 11 rate of suicide that we would expect across the board? 12 A. Now, Mr. Vickery, what I would like you to do 13 here, to help me out, would be the following: I would 14 like you to write down a series of figures, if this 15 will be okay. 16 Q. Okay. 17 A. They are the figures that have been thought for 18 years to be the figures, the rates at which people who 19 are depressed commit suicide, and I'd like you to 20 write these down in three different columns. 21 Q. Okay. 22 A. On the left-hand side, I'd like you to put the 23 figure 200. In the middle column, I'd like you to put 24 the figure 600, and on the right-hand side, I would 25 like you to put the figure 790. Now, let me quickly PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 872 1 explain what those are. 2 Q. Okay. 3 A. The senior figure in this field who has come -- 4 who produced the two figures on the left and in the 5 middle is a man called Professor Samuel Guze from 6 Washington State University, St. Louis. He said -- 7 Q. G-U-Zed-E guy. 8 A. G-U-Z-E. 9 Q. I'm just teasing you about the way you say Z. 10 A. I know you're teasing me, yes. 11 Q. G-U-Z-D? 12 A. E. 13 Q. E, Guze. 14 A. Now, for many years people like me have been 15 very concerned to make sure that we try and reduce the 16 risk that people who are depressed actually commit 17 suicide because this is a very high risk. This is 200 18 per 100,000 patient years or 600 per 100,000 patient 19 years, and maybe the worst case scenario is a figure 20 that comes from Sweden that has been cited by Dr. Gary 21 Tollefson from Eli Lilly is 790 per 100,000 patient 22 years. 23 Q. This is rates of suicide for depressed people? 24 A. This is rates of suicide for depressed people. 25 The rates of suicide in the community, just you and PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 873 1 me, if we had no nervous problems of any sort, should 2 be 10 per 100,000 patient years. 3 Q. Let me write it in a different color. 4 A. Put it up at the top maybe just for the moment 5 because we're going to have a few more figures to add. 6 So 10 per 100,000 person years. 7 Q. Patient years? 8 A. Person years for us. The other figures below 9 are 200 per 100,000 patient years. 10 Q. Let's compare apples to apples. Is this fair? 11 A. It is fair. 12 Q. So there's ten in the regular population and 13 then Dr. Guze said 200 or 600? 14 A. Yes. 15 Q. Why does he give two figures? 16 A. Well, the work has generally indicated that it 17 falls in that range. It's somewhere in between 200 18 and 600. 19 Q. Okay. But Dr. Tollefson from Lilly said 790? 20 A. Well, he cited a study from Sweden to come to 21 that figure. 22 Q. Okay. Now, what does the work by Boardman and 23 Healy tell us about the rate? 24 A. What I would like you to do now, Mr. Vickery, 25 is to write down three more figures that come from the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 874 1 Jick study. In the left column I want you to write 2 the figure 95. You probably want to write it higher 3 up because we're going to go down the page a bit. 95, 4 and then in the middle the figure 187, and then on the 5 right-hand side the figure 357. 6 Q. And those are all three from Jick? 7 A. They are. 8 Q. And can you explain for us the significance of 9 those three figures? 10 A. Where you saw the figure 187 before, you saw 11 the confidence interval went from 1.1 to 4.1, and if 12 you apply that interval to the figure 187, what you 13 get on the left-hand side is the best case scenario 14 for Prozac. It's 95 per 100,000 patient years. 15 What you get in the middle is the most likely 16 scenario for Prozac which is 187, and what you get on 17 the right-hand side is a figure that Eli Lilly could 18 not reassure you isn't the true figure. It's probably 19 not the true figure, but they can't say to you that 20 this couldn't be the true figure which is 357. 21 MR. SEE: Well, Your Honor, I move to strike 22 Dr. Healy's last statement, "is probably not the true 23 figure." In his opinion, if it's probably not the 24 right figure, then we ought not be hearing about it. 25 Q (By Mr. Vickery) Let me ask you this: Let's PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 875 1 get the rules. I know you've never done this before, 2 but when Mr. See stands up, I've got to do the 3 talking, okay? 4 A. Okay. 5 Q. Is there significance to the fact that the top 6 end of the Jick confidence interval has 357 even 7 though you said it's probably not the true figure? 8 A. What I'm saying to you is that if you want to 9 bet money, and the more money that you wanted to bet, 10 you would go for a figure of 187. However, if you 11 want to take a flutter with a small amount of money 12 and maybe win a complete jackpot, you might try the 13 figure of 357 because there's a chance that that's the 14 right figure also. 15 Q. Okay. Tell us then -- 16 THE COURT: You still seeking that that be 17 stricken? 18 MR. SEE: Absolutely. He said, "there's a 19 chance." It's pure speculation on his part. 20 THE COURT: But he's not exactly opining that 21 Lilly's study is correct, is he? He's just analyzing 22 what Dr. Tollefson has done. 23 MR. SEE: As I understand what he was saying, 24 he's saying that the figure 357 was -- first, he said 25 probably not the right figure, and then said there's a PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 876 1 chance that it's correct. The objection is he's 2 speculating. 3 Q (By Mr. Vickery) Are you speculating? 4 A. No, I'm not. What the figures you have there 5 means this, the true figure lies between 95 and 357. 6 If you're going to bet money, I would advise you to 7 bet on 187. However, if you are concerned about this 8 drug, a company employee from Eli Lilly cannot say to 9 you for certain that 357 is not the right figure. 10 That's what these figures mean. 11 THE COURT: I'll deny the objection. 12 Q (By Mr. Vickery) Okay. Now, Dr. Healy, where 13 do we go from here? What's the next step in the 14 analysis? 15 A. Where we go from here is if you look at these 16 figures, it's obviously clear that people who are 17 depressed are much more likely to commit suicide than 18 they would ever be likely to commit suicide if they 19 went on a drug like Prozac even under the worst case 20 scenario. 21 Q. Okay. 22 A. The problem with that is Dr. Guze drew his 23 figures, as you see there, from studies done in the 24 1920s and '30s, and '40s and '50s in Germany and 25 Sweden and the United Kingdom and the United States, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 877 1 and these are figures drawn from hospitalized cases of 2 depression exclusively. 3 Q. Woe, okay. Let me write that down. These are 4 people in the hospital. 5 A. These are severe cases of depression. Now, 6 there is strong evidence that Prozac does not work for 7 this group of people, and it is used primarily in 8 primary care. It is not used in hospital care for 9 severe depression. It is used in primary care, and 10 Dr. Jick's figures come from primary care in the 11 United Kingdom where you would expect the risk to be 12 much lower. 13 What we haven't known until recently is just 14 what this risk should be. The first person to put the 15 possible risk on the map was a man called Morrison 16 from San Diego who looked at primary care in San Diego 17 County and you can put down in the middle column, 18 Mr. Vickery, the figure 42. 19 Q. Okay. 20 A. And he found the rate for primary care 21 depression to be 42 per 100,000 patient years. 22 Q. Have others found different rates for mildly or 23 moderately depressed people? 24 A. There have been three other studies, which I'm 25 going to take you quickly through. The second one PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 878 1 comes from Holland, which they have also looked at 2 people who have been treated in primary care. In the 3 column beneath the 42 of 337. That's their estimate 4 of the likelihood of committing suicide from 5 depression if you're being treated in primary care. 6 Now, the next figure -- there's two other 7 figures which come from Dr. Boardman and myself. We 8 authored two different figures. One is all people who 9 are depressed, both of those that go to the hospital 10 and those who are treated in primary care, every 11 single person who is depressed in the Black Country in 12 England during this five-year period, and what we get 13 for all of those, which include the most severe 14 depressions, is the figure of this in the middle 15 column of 44. Why isn't it as high as the 200 or 600 16 you see above is because this includes both the people 17 in the hospital and out in the community in primary 18 care. 19 Now, we've been able to remove the people who 20 have gone into the hospital and just looked at the 21 figure for primary care. Okay. These are the people 22 that Dr. Jick was looking at, and the figure that we 23 have for the middle column is -- you need a bit more 24 space -- is 15.8. 25 Q. Okay. Now, let me see if I can -- if I PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 879 1 understand it. If I do, I'm sure everyone on the jury 2 will. These figures down here, the 15.8, is that 15.8 3 per 100,000 -- 4 A. Patient years, yes. 5 Q. And that is of people that are depressed in 6 primary care? 7 A. The group of people that Dr. Jick was looking 8 at. 9 Q. Okay. So let's do it this way: 15 point, what 10 was that, 8? 11 A. Point eight. 12 Q. Okay. 13 A. Sixteen would be an easier figure to use if you 14 want. 15 Q. And the number in that from that same patient 16 population, according to Dr. Jick's study who 17 committed suicide on Prozac was what? 18 A. Well, the best case scenario for Prozac is 95, 19 which is six times higher. 20 Q. Let's take the most likely case. 21 A. The most likely case is 187, which is 12 times 22 higher. 23 Q. Are you saying, Dr. Healy, that people on 24 Prozac from this same group of patients have a 12 25 times higher risk of suicide? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 880 1 A. I'm saying to you, Mr. Vickery, that neither -- 2 that Eli Lilly could not reassure you or me or anyone 3 else in the court that the true figure couldn't even 4 be 23 times higher. Twelve times higher is the most 5 likely. 6 Q. That's taking into account the underlying 7 depression. We can't blame the underlying depression 8 on this? 9 A. How do you mean, Mr. Vickery? 10 Q. I tell you why I asked that. Back here you 11 said that Dr. Tollefson from Lilly said that 790 12 people -- let me finish the question -- 790 people out 13 of 100,000 who were depressed commit suicide, but 14 you're saying it's only 15 people, so I'm trying to 15 figure out the difference here. Can we safely blame 16 the underlying disease or not? 17 A. Could I go a little bit further, Mr. Vickery? 18 Our figure of 15.8 includes the vast majority of 19 people who are depressed in the United Kingdom. For 20 every one person who goes to hospital, 20 -- between 21 20 and 40 people are treated by their general 22 physician. 23 So this is the vast majority of people who are 24 depressed, but it includes some very mild depressions 25 who may be put on Prozac, and it includes some more PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 881 1 moderate depressions also, so the figure of 15.8 is a 2 mean figure. There is only one study that has ever 3 been done in the world that has calculated the rates 4 of suicide for only mild depression in community care 5 anywhere, and this is the study that Dr. Tollefson has 6 used, which comes up with the figure of 790 per 7 100,000. That was the figure for the hospitalized 8 patients. 9 Q. Okay. Let me go back then. Dr. Tollefson's 10 figure of 790 was also hospitalized people? 11 A. They were all hospitalized patients. Now, from 12 exactly the same study in Sweden and -- just, the jury 13 needs to perhaps appreciate what's involved here. To 14 run this kind of study what you need is the kind of 15 town or the kind of place where there's not too many 16 people moving in and not too many people moving out, 17 and you ideally want to track them over 10, 20, 30, 40 18 years. 19 This particular study tracked people over, 20 between 30 and 40 years, and they came up with a 21 figure for mild depression in the community, and this 22 is a figure that will be mild depression where the 23 people were often left untreated. They did not have 24 the benefit of antidepressant treatment -- well, the 25 benefit or the risk of antidepressant treatment, and PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 882 1 I'd like you to add in wherever you think is 2 appropriate, the figure for mild depression from that 3 Swedish study. 4 Q. Okay. Same study Dr. Tollefson wrote on? 5 A. Yes, it is. 6 Q. But the people who were not in the hospital, 7 what's the number that committed suicide? 8 A. Zero. 9 Q. Zero? 10 A. Yes. Can I explain a bit more about this? 11 Q. Is there something significant about it? 12 A. There is. There's something highly 13 significant. It's the thing I've thought for a long 14 time and a number of other experts in the field have 15 thought for some time and it's this: That just 16 because you've been depressed and just because you've 17 been suicidal before in the past, you may have talked 18 in the past about being suicidal, in actual fact, that 19 doesn't increase your risk of committing suicide 20 necessarily. Remember the figure for the population 21 generally is ten. 22 What does increase your risk is if you try to 23 commit suicide. Just having suicidal thoughts is not 24 a problem, is not necessarily anything that's going to 25 make -- I'm sure quite a few people in the court have PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 883 1 had suicidal thoughts. I know I've had them in the 2 past without being depressed. I'm sure an awful lot 3 of you have had them. 4 A lot of people who will be mildly depressed 5 will have thoughts like this and these figures suggest 6 that even having these kind of thoughts may inoculate 7 you against suicide, and it's only when something else 8 happens in your life that then you may be pushed 9 towards suicide. 10 Q. How would it inoculate you if you -- let's say 11 you've had -- I've had a bad day at court. Things 12 just haven't gone my way and I walk out of court and 13 go, boy, I'd just like to jump in the ocean. How does 14 just having that thought, in any way, serve to protect 15 me, in fact, from doing such a thing? 16 A. Well, all the evidence at the moment is that 17 unless you are -- I mean, the one we know is that when 18 you go on pills, psychotropic agents of any sort, from 19 alcohol to illegal drugs on the street, to the 20 antidepressants to the antipsychotics, your risk of 21 suicide goes up. 22 Changes in your life put your risk of suicide 23 up. Simply being depressed and having suicidal 24 thoughts does not in itself put the risk up. It's 25 other things happening to you that throw you off PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 884 1 balance that put your risk up. 2 Q. Okay. Thank you, Dr. Healy. Let's move now 3 from epidemiology back to the third way that we talked 4 about looking at this issue, which was the randomized 5 clinical trial. And can you tell us why it is that 6 that is not a good way to either prove or disprove 7 that Prozac causes suicide and violence? 8 A. Well, there's a few different reasons. Let's 9 say we were to look at whether Prozac works as an 10 antidepressant. It's a weak antidepressant. In order 11 to show that it worked as an antidepressant, we would 12 need two courtrooms full of people, half of whom got 13 sugar pill and half got Prozac. And at the end of the 14 day we'd probably just about be able to show that 15 slightly more people who took Prozac got well compared 16 to the people who took the sugar pill. In fact, if 17 the courthouse was full of very severely depressed 18 people, we wouldn't be able to show that at all. 19 Q. Is that that placebo effect we're talking 20 about? 21 A. That's the placebo effect. 22 Q. Let me see if I follow the reasoning of that. 23 If a person is depressed and they go to a doctor like 24 yourself in whom they might have confidence in and 25 say, give me something to help, and you say, yes, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 885 1 here. I'm going to give you this pill, Mr. Vickery. 2 Is there something about just the fact that I've 3 gotten a pill from a guy like you with a lot of people 4 will make them respond, and all of a sudden, they're 5 not depressed anymore? 6 A. Absolutely, Mr. Vickery, yes. Now, the problem 7 in terms of trying to work out cause and effect from 8 that is, let's say in the courtroom here you had been 9 one of the people who had seemed to get well on 10 Prozac. What I wouldn't know, therefore, was whether 11 you'd got well because of the Prozac or because you 12 just got well from the therapeutic gesture, the 13 placebo effect. 14 So we can know from that kind of trial that 15 slightly more people may be likely to get well on 16 Prozac, but we don't have good cause and effect. We 17 don't know, in your case for instance, that it was the 18 Prozac that got you well. 19 Now, the other important thing in this area, 20 and this is an area where we certainly could improve 21 things, which is the way we collect side effect data 22 from clinical trials. The clinical trials we do -- 23 actually, there are two or three points. One is we 24 use rating scales, and the primary rating scale that 25 gets used to test whether an antidepressant works is PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 886 1 named after a man called Max Hamilton, and it's called 2 The Hamilton Rating Scale for Depression and that's 3 abbreviated down to Ham-D usually. 4 Now, if I was trying -- let's say all of you in 5 the court had volunteered to participate in a clinical 6 trial -- 7 MR. SEE: Your Honor, at this point I'm going 8 to object. He's now going beyond the scope of his 9 report. 10 Q (By Mr. Vickery) Let me confine you to the 11 published scientific literature, okay? Let me ask you 12 this: I expect that we are going to hear some 13 testimony about clinical trials and the data that was 14 accumulated by Lilly in the clinical trials. Have you 15 seen, in the published scientific literature, an 16 analysis done by a Lilly scientist named Charles 17 Beasley going back and looking at this issue of 18 suicidality based on the people that were tested in 19 the clinical trials? 20 A. Yes, I have, Mr. Vickery. 21 Q. When that article was published, what journal 22 was it published in? 23 A. It was in the British Medical Journal. 24 Q. And when that article appeared in the British 25 Medical Journal, what did you do? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 887 1 A. Well, I was very disturbed, as a member of the 2 British Medical Association, that my journal had been 3 happy to publish this article, not because, at this 4 stage, that I thought that there was a particular 5 problem with Prozac. I thought the arguments that 6 were being put in the article were scientifically 7 flawed. 8 So I did a thing, which I rarely, rarely do -- 9 I've done it twice in my career, I think -- and that's 10 written to the journal in question, and said look, 11 there are serious problems with this study. 12 Q. And is that typical when an article appears 13 that there are letters to the editor from other 14 scientists? Is that typically done and does the 15 journal publish those letters? 16 A. Yes, they often will. The issue will actually 17 depend on the editor of the journal, whether he thinks 18 this is an issue that really needs to be aired or not. 19 Whether the issue of this particular piece of work not 20 been done correctly is one that needs to be thrown 21 into the public domain. 22 Q. Okay. And did the British Medical Journal 23 choose to print your letter of protest, if you will, 24 about this article being published? 25 A. They did. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 888 1 Q. Is it customary, when that's done, for the 2 journal to give the author of the article, 3 Dr. Beasley, the courtesy of a response? 4 A. It is. 5 Q. And did, in fact, Dr. Beasley send in a 6 response to the British Medical Journal responding to 7 your criticism of his article? 8 A. He did. 9 Q. And please tell us -- this is real important -- 10 when Dr. Charles Beasley of Dr. Eli Lilly wrote back 11 in response to your criticism, which of these three 12 methods did he say was the preferred method for 13 testing this phenomenon? 14 A. He said that challenge/rechallenge was 15 scientifically appropriate. 16 Q. And tell us, if you will, sir, whether or not 17 you're aware of Dr. Beasley actually preparing a 18 protocol for Eli Lilly to study this issue? 19 MR. SEE: Objection, Your Honor. The question 20 is beyond the scope of this witness' report. 21 MR. VICKERY: This is a fact question, Your 22 Honor. It is not an opinion question at all. It is a 23 simple fact. 24 THE COURT: I'll sustain the objection. 25 Q (By Mr. Vickery) Now, so let's talk about PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 889 1 Dr. Beasley's analysis of the patient's in the 2 clinical data. 3 MR. VICKERY: Before we do that, though, I have 4 a stipulation, Your Honor, I'd like to offer at this 5 time. Does the Court desire me to read it or are you 6 going to instruct the jury? How would you like me to 7 handle it? 8 THE COURT: Well, I assume that you and -- 9 MR. VICKERY: It's signed by Mr. See. Mr. See 10 and I both -- actually, it's signed by Ms. Mangrum. 11 We signed it this morning. 12 THE COURT: Okay. I will instruct the jury 13 that since the parties have agreed to that 14 stipulation, you should consider the facts as having 15 been proved. 16 MR. VICKERY: Thank you, Your Honor. "The 17 facts are stated as follows: The parties stipulate 18 that it is well accepted and appropriate medical 19 practice to exclude patients at serious risks of 20 suicide from outpatient clinical studies involving 21 antidepressant medications. Number two, patients at 22 serious risk of suicide were excluded from Eli Lilly 23 and Company's outpatient clinical trials involving 24 Prozac. And number three is neither plaintiffs nor 25 plaintiffs' expert witness criticize Eli Lilly and PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 890 1 Company's exclusion of patients at serious risk of 2 suicide from the outpatient clinical trials involving 3 Prozac." 4 Q. Now, of what significance is it if there's no 5 criticism about the fact that Lilly excluded people at 6 serious risk from the clinical trials? Is that of 7 significance in any way when they then go back to 8 analyze retroactively the clinical trial data to see 9 if there is a problem with suicide and violence -- I 10 mean, Prozac and suicide and violence? 11 A. There are two or three problems, Mr. Vickery. 12 Q. And what are they? 13 A. Let me quickly take you through them. One is 14 they relied on one of the items from the Hamilton 15 Rating Scale for Depression. This is a list of 16 different items which clinical people like me would 17 want to rate people who are depressed in clinical 18 trials on. It's only oriented, from my point of view, 19 I have to say to you, in clinical trials. The patient 20 is rarely offered the opportunity to use rating 21 scales, which exist, some of which have been produced 22 by Eli Lilly, which are called quality of life rating 23 scales, to rate whether they think they're improving. 24 Okay. Now, using -- there's only evidence that 25 Prozac works at all when you use the Hamilton scale PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 891 1 for depression. There's no evidence that it works 2 when the patient is left to rate the outcome 3 themselves, but using the Hamilton Rating Scale for 4 Depression, there's one item on suicidality. 5 Q. Is that Ham-D item three? 6 A. That's Ham-D item three. 7 Q. Who rates it, the physician or the patient? 8 A. The physician rates it, and typically without 9 really talking very closely to the patient, and in 10 particular, given that the patient -- 11 MR. SEE: Your Honor. Pardon me, Dr. Healy. 12 Your Honor, I object because of the witness' 13 speculation. It's impossible that this witness has 14 personal knowledge about how patients in clinical 15 trials were or were not carefully rated by the 16 physicians conducting the trials. It's speculation. 17 THE COURT: Mr. Vickery. 18 MR. VICKERY: I'll move on to something else. 19 THE COURT: All right. I'll sustain the 20 objection. 21 Q (By Mr. Vickery) Let me ask you this: The 22 Ham-D rating scale, item three, Ham-D -- may I confer 23 with Mr. See for a matter, Your Honor? It's just a 24 quick question. 25 THE COURT: Well, let's take a break now. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 892 1 Please be back at ten after eleven. 2 (Whereupon, a recess was taken from 10:55 a.m. 3 to 11:20 a.m.) 4 THE COURT: Please proceed, Mr. Vickery. 5 MR. VICKERY: Thank you, Your Honor. 6 Q. Dr. Healy, before the break, we were talking 7 about this Ham-D item three that was used by 8 Dr. Beasley in his analysis. It's actually called a 9 meta-analysis, wasn't it? 10 A. That's correct. 11 Q. Is that just a word that means you're looking 12 back at something after the fact? 13 A. No. It means -- well, yes, it does mean that, 14 but it also means that you pull a few different 15 clinical trials together. 16 Q. And was this the use -- Dr. Beasley's use in 17 the published meta-analysis of the Ham-D item three as 18 the vehicle to get his arms around the issue of Prozac 19 and suicide, one of the things that caused you to 20 write a letter of protest to the British Medical 21 Journal? 22 A. It was. 23 Q. Now, explain for us how this Ham-D item three 24 works? I mean, is it some kind of a scale or what is 25 it? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 893 1 A. Well, it's the third item on Max Hamilton's 2 scale, and in essence, it is a four or five-point 3 item. I would have to have the actual scale here 4 before me to be able to give it to you, but what you 5 do is if the patient has no thoughts of suicide at 6 all, no actions of any sort, you rate zero. If there 7 may be some thoughts, some ideas, you would rate one. 8 If they're more actively thinking about it, you would 9 rate two. If they've got plans, clear plans to commit 10 suicide, you'd rate three. And if they'd actually 11 tried to commit suicide, you would rate four. I mean, 12 tried to commit suicide within a few hours or one or 13 two days from the time you took the rating as opposed 14 to any point during their life. 15 Q. And again, it's written by the physician not 16 the patient? 17 A. It's purely from the point of view of the 18 physician. It depends critically on sensitive 19 questioning and detailed questioning by the physician, 20 and Max Hamilton, whom I knew before he died, did not 21 see it as an instrument to rate treatment of urgent 22 suicidality. 23 Q. This is a kind of thing -- well, I think we 24 gave the jury a big long questionnaire that had 25 similar kind of things, that people can rate from one PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 894 1 to five how you feel about something? 2 A. Yes, very similar. Yes. 3 Q. And this is what Lilly used to try to get their 4 arms around it? 5 A. Yes. 6 Q. Now I want to show you something and what I 7 will show you are statements written by Mr. See during 8 the opening statement, his opening statement to this 9 jury. And down here on the bottom he talks about such 10 things as fear of being alone, low self-worth, 11 hopelessness, helplessness, lonely, dependent, mental 12 sharpness, reclusive. Are those sorts of things -- is 13 there any measurement on the Ham-D item three to 14 measure those sorts of things? 15 A. There isn't any measurement in any part of the 16 Hamilton scale, not just in the Ham-D three, to 17 measure most of those points. 18 Q. Were there publicly available measurement 19 tools, like the Ham-D scale, back when Lilly was doing 20 the clinical trials, that could have been used to look 21 at these factors that might predispose -- 22 MR. SEE: Objection, Your Honor. Going beyond 23 the scope of the witness' report. 24 MR. VICKERY: Your Honor, this is simply a fact 25 question about what was available back then. It's not PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 895 1 an opinion at all. 2 THE COURT: I'll overrule the objection. 3 THE WITNESS: Yes, there were, and as I said, 4 the Hamilton scale and item three was not designed to 5 look at the question of people becoming suicidal on an 6 antidepressant. 7 Q (By Mr. Vickery) Are these -- 8 A. There are other scales which have been designed 9 to look at people becoming -- actually, becoming 10 suicidal. 11 Q. Is one of those called the Beck scale? 12 A. It is. 13 Q. Was it published back in 1979? 14 A. It was. 15 Q. And does it look at these kinds of factors and 16 others which might predispose someone towards 17 committing suicide? 18 A. It does. 19 Q. So you were telling us, I believe, that there 20 were two or three reasons that caused you to protest 21 about the way that Lilly looked or analyzed this 22 issue. One was Ham-D. What were the other two? 23 A. One of the other issues is, generally, in the 24 course of clinical trials, the way we collect side 25 effect data. Curiously, I have pointed to the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 896 1 weaknesses in the randomized-controlled trials, but 2 you could, curiously enough, use a placebo-controlled 3 randomized trial to establish the frequency with which 4 fluoxetine causes akathisia or nervousness, and there 5 are some indications from Lilly's own database as to 6 what this frequency is. 7 Q. And what is it? 8 A. Well, I have to explain one thing to you first 9 of all, which is, if any drug company is asking me, 10 the rating physician, to rate whether a particular 11 side effect is happening, in the ordinary course of 12 events what they will want is the way the patient 13 themselves describes it, and they'll say to you in 14 regards to akathisia -- and this is not just Eli 15 Lilly. They'll say that akathisia is not the kind of 16 word that any patient would ever use, is it, Doctor? 17 And I'd say, no. And they'd say, well, look, we 18 suggest that if this is happening, what you do is you 19 code it under nervousness. This is the appropriate 20 term to use. 21 Now, if you look at the placebo-controlled side 22 effect database for fluoxetine as published by them in 23 public at the European College, at the 24 Neuropsychopharmacology meeting in autumn of 1997, you 25 can get rates for the side effects that have been PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 897 1 declared, and you get a rate for Prozac-induced 2 anxiety of 12.1, I believe, and you get a rate for 3 Prozac-induced nervousness of 13.7. 4 Now, we also know from -- 5 Q. Let me make sure we understand. Does that mean 6 that 12.1 and 13.7, if my math is good, is 25.8, so 7 nearly 26 people out of every hundred that got it, in 8 the clinical trials got either anxiety or nervousness? 9 A. That figure refers to the figure that me, the 10 practicing psychiatrist, will have picked up. We know 11 from a lot of other research, some excellent research 12 done by Lilly themselves, that the true rate of side 13 effects that occurred -- but we see in clinical 14 trials, I would have a patient taking a particular 15 drug, and they'd come back to me each week and I would 16 say, look, how are you doing? Are you having any 17 problems? This is what's call spontaneous reporting. 18 And if the side effect you're having is an 19 unusual one that you can't put in words or an awkward 20 one like the fact that you don't seem to be having a 21 normal sex life or whatever, you're not going to 22 report it to me all that easily. 23 Now, we know that if as opposed to me depending 24 on the spontaneous reports that people give me about 25 the problems that they're having with the drug, we PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 898 1 give them systematic checklists, and this has been 2 done by Lilly themselves, that for every side effect 3 that's spontaneously reported, it is recorded as 4 happening three times more frequently with the 5 checklist. Not only that, the spontaneous reports 6 only pick up a quarter of the side effects that are 7 happening. I mean, there's a whole lot of side 8 effects that are just not spontaneously reported at 9 all. 10 Q. Let me stop you there and make sure we 11 understand. Are you saying that if you depend on me 12 telling you that I'm nervous or telling you that I'm 13 anxious, you're far more likely to get that 14 information out of me than if you give me a little 15 checklist that let's me check off, yes, I've been 16 feeling nervous or anxious? 17 A. No. If we give you the checklist and you're 18 able to go into a room on your own and things like 19 that, and check all the things that you think are 20 happening to you since you went on this drug, it's 21 much more likely, at least three times more likely -- 22 in fact, let me give you a good figure. When the 23 clinical trials using the side effect -- the method of 24 rating side effects that we use in the clinical trials 25 for Prozac. When they estimated what the rate of PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 899 1 sexual dysfunction with the drug was, the rate came 2 out at 5 percent. This is -- 3 MR. SEE: Your Honor. If I may, Dr. Healy. I 4 object, beyond the scope of the report and I'll ask to 5 approach? 6 THE COURT: I'll sustain the objection. 7 Q (By Mr. Vickery) Let's stay away from that. 8 What we were talking about, is there a problem with 9 the way that data is collected in the clinical trial 10 that hides or underreports the true frequency of the 11 problems? 12 MR. SEE: Object, Your Honor. It's beyond the 13 scope of the report. 14 THE COURT: Mr. Vickery. Sustained. 15 MR. VICKERY: I think he's right, Judge. I 16 think it is. 17 Q. Let's move on to the third criticism that you 18 had of Dr. Beasley's article that caused you to write 19 your letter to the British Medical Journal. What was 20 that? 21 A. I've been slightly confused by the recent 22 exchange. I'm trying to remember what my third 23 criticism was. Can you move on to something else? 24 Q. I don't know. I don't have it in my notes. 25 Let's go on then. Bottom line on the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 900 1 randomized-clinical trial, is it fair to say that it 2 is simply not a good tool to measure the question of 3 whether Prozac causes suicide and violence? That's 4 not the preferred tool to do it? 5 A. That is absolutely correct. As I have written 6 in several reviews, the randomized-controlled trial as 7 conducted in the testing of pharmacological agents is 8 a business exercise, not a scientific exercise. It 9 does not establish the frequency with which adverse 10 effects may be happening. It does not establish the 11 overall quality of life that the individual patient 12 themselves are having. It's simply not empirical. As 13 practiced, it's not scientific. 14 Q. Okay. Now, who invented this whole notion of 15 randomized clinical trials? 16 A. It was a man called Austin Bradford Hill. 17 Q. And was he, in fact, knighted by the Queen? Is 18 he Sir Austin Bradford Hill? 19 A. He was before he died, yes. 20 Q. Was he an epidemiologist, by the way? 21 A. Yes, he was. 22 Q. And did he give us a framework of nine factors 23 that we might look at, moving from general to specific 24 causation, to sort of put a framework for us to 25 discuss whether -- to discuss the bases for your PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 901 1 opinion that Prozac in this case caused Bill Forsyth 2 to commit suicide? 3 A. He did. He gave the generally accepted 4 framework for doing so. 5 Q. All right. There are nine factors, are there 6 not? 7 A. There are. 8 Q. And I do have those in my notes, so let me ask 9 you about the first one. Number one is strength of 10 association. Could you tell us, Dr. Healy, first of 11 all, what that means? 12 A. It can mean two things. It can mean strength 13 in the sense of how likely is this to happen if you 14 happen to have a particular drug or a particular 15 condition, and it can also mean how frequently does it 16 happen. 17 In terms of how likely this is to happen, 18 Mr. Vickery, it's something in the area -- if you were 19 to have a drug and grow feathers, you know, this is 20 just not likely to happen in the ordinary course of 21 events, so you would strongly suspect an association 22 between the drug and what had happened to you. 23 Q. Yes, I would. 24 A. In the case of akathisia, as I explained 25 earlier, it is invariably drug induced. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 902 1 Q. Ah, okay. Now, is the strength of association 2 something that is usually measured with a numerical 3 figure? 4 A. No. It's very hard to put a figure on, for 5 instance, you growing feathers. 6 Q. Right. 7 A. It's very hard to do that. It can be if you go 8 into the epidemiology and look at the -- what we can 9 do is if you're looking at it from the point of view 10 of the frequency with which the thing happens, you can 11 go into the epidemiology and look at the relative 12 risks, which we have done earlier. 13 Q. Okay. So the relative risks that we've looked 14 at earlier, first, we have the Jick risk of 2.1, 15 correct? 16 A. Well, this is 2.1 relative to Dothiepin. I 17 think the true figure is anything between 6 and 22. 18 Q. Six and twenty-two, okay. And then when we 19 compared it with the study that you and Dr. Boardman 20 had done, I think we illustrated it was about 12 times 21 higher in a depressed population of the same kind of 22 people, from the same area of people taking Prozac, 12 23 times more frequent suicide than people who are not, 24 right? 25 A. Yes. Well, that's where I have the figure from PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 903 1 6 to 22 from. Twelve is midway in there. 2 Q. Okay. Is that a fairly strong strength of 3 association, a strong association? 4 A. That is an extremely strong association, 5 Mr. Vickery. You rarely see stronger. 6 Q. Okay. Now, number two is called temporal 7 relationship, right? Am I correct about that? 8 A. You are. 9 Q. And what is a temporal relationship? 10 A. Well, if you grew the feathers before you had 11 the drug, then clearly, I would be much less likely to 12 suspect that the drug had caused it. If it happens 13 after you take the drug, then, yes. What you want to 14 see is that the phenomenon that you're looking at 15 happens after you actually take the drug. 16 We know that there can be much longer term 17 effects that happen maybe years after you've had a 18 drug, and it can be harder to prove cause and effect 19 in these instances. However, if you take a drug and 20 become akathisic within hours or days having had it, 21 and in particular if you become suicidal, ten days 22 after having had it, and a number of other studies 23 show the same thing, then you've got a very strong 24 temporal association that points to the drug being 25 causative. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 904 1 Q. Okay. Let me follow-up on that feathers 2 business a minute. What if I took the drug now, but I 3 grow feathers a year from now and you did blood tests 4 on me and there's none of that drug in my body -- 5 A. Yes. 6 Q. -- that's pretty weak, isn't it? 7 A. This is where it gets weaker, yes. It still 8 could be the case that the drug is causing the 9 problem, but we wouldn't know for sure. We would have 10 to have other things in there to lead us to believe 11 that this was the case. 12 Q. So is it important to know whether or not the 13 drug is in the body and is active? 14 A. Not necessarily in the body and active, but 15 obviously that makes things much stronger, but that 16 the phenomenon has happened recently after you've had 17 the drug. It could have been that the drug has been 18 cleared out of the body and the phenomenon appears 19 within hours or days after that, because the drug hits 20 the system and things don't just go back to normal 21 because the drug is out of your body. 22 Q. Well, we have two pieces of information 23 already. Number one, we know that this happened ten 24 days after Mr. Forsyth started taking the drug, right? 25 A. Yes. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 905 1 Q. And number two is we know that Prozac was in 2 his body when his body was autopsied after his death, 3 correct? 4 A. That is correct. 5 Q. And what do those two things suggest to us as 6 we think about the temporal relationship? 7 A. Well, what they actually suggested very 8 strongly to me at the time that I read the original 9 details of the case was this is what I had come to 10 recognize as the problem that's caused by Prozac. 11 This was what had happened to the man that I had seen. 12 This is what has happened to another man that I've 13 been involved in the case where ten days after he took 14 Prozac, he killed his wife and committed suicide. 15 This is another man, not Mr. Forsyth. 16 Q. Okay. And is this what happened in the 17 patients that were reported by Teicher? 18 A. This is what happened. 19 Q. Rothschild? 20 A. It was a week to three weeks afterwards, yes. 21 It's in that time frame. The earlier reports it at a 22 slightly wider time frame, but the field is generally 23 narrowed down into the area of saying this will happen 24 in the first week or two, and in order to try to 25 ameliorate the problem, it is common clinical practice PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 906 1 throughout the USA and Europe to give benzodiazepines 2 or other drugs for the first two or three weeks when 3 you go on Prozac, and incidentally, in the clinical 4 trials that were done with Prozac, benzodiazepines 5 were co-administered so this would have helped conceal 6 the problem. 7 Q. Okay. 8 MR. SEE: Your Honor, I object. I ask that the 9 last statement be stricken. It's beyond the expert's 10 report. 11 THE COURT: Let's have a side bar. 12 (Whereupon, the following proceedings were had 13 at side bar out of the hearing of the jury.) 14 MR. SEE: It is not, I suspect, accidental that 15 this has happened. The doctor has shown in demeanor, 16 in my view, that he's doing this on purpose. How the 17 clinical trials are conducted, he has not opined in 18 any way. It's not in his report in any way. I think 19 he's doing his very best to throw things in that he 20 should have been instructed by Mr. Vickery not to put 21 in. It is calculated, and I move this be stricken and 22 the jury directed to disregard it. 23 MR. VICKERY: Your Honor, first of all, I don't 24 think that Dr. Healy is trying to slip anything in. I 25 simply gave him the Court's in limine orders. I PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 907 1 talked to him about this. This man, unlike the 2 witnesses Lilly is going to call, has simply never 3 been a witness before. That's why I tried, as best I 4 can -- 5 THE COURT: I see his point. 6 MR. VICKERY: Yes, I think it should be 7 stricken, but it's simply not intentional. The last 8 statement about Lilly's clinical trial with 9 benzodiazepine -- 10 THE COURT: Benzodiazepine. 11 MR. VICKERY: -- benzodiazepine 12 co-administered. It is much to do about nothing, 13 because there's no dispute about it, but certainly it 14 was not in his report, and I have no problem with the 15 jury being instructed to disregard his last statement 16 regarding benzodiazepines being co-administered. I 17 have no problems with that. 18 THE COURT: Benzo -- 19 MR. VICKERY: Benzodiazepine. They are 20 sedatives. 21 THE COURT: It's a sedative. Is that it? 22 MR. SEE: Yes. It would be correct to 23 disregard his last sentence. 24 (Whereupon, the following proceedings were had 25 in open court in the presence of the jury.) PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 908 1 THE COURT: The Court will instruct the jury 2 that Dr. Healy's last sentence is stricken and you are 3 to disregard it. Please proceed, Mr. Vickery. 4 Q (By Mr. Vickery) Dr. Healy, on this temporal 5 relationship issue, when Dr. Jick was doing his 6 epidemiological study, did he specifically provide a 7 table in there showing how many of the folks, that 187 8 per 100,000 patient years that committed suicide, how 9 many of those had done it on Prozac early? 10 A. Yes, he did. He distinguished between those 11 who had recently been put on Prozac versus those who 12 had been on it for some time, and he showed that the 13 figure for those who had been recently put on it was 14 274 per 100,000, which is completely in line with the 15 other reports that I've outlined to you. 16 Q. Okay, sir. Let's moving right along. Sir 17 Austin Bradford Hill said the third thing we should 18 look at in finding specific causation is consistency 19 of the association. What does that mean? 20 A. The consistency of the association means a few 21 things. One is that you would like to have a number 22 of different people finding it. You wouldn't want one 23 expert saying I see this happening and see it 24 happening the whole time. You want a range of 25 different experts, ideally worldwide, saying they've PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 909 1 seen this kind of thing happening, and you'd want it 2 happening in a consistent temporal relationship. 3 For instance, now, the record in this instance 4 is, I think, entirely consistent in that the general 5 body of opinion is that when this phenomenon happens, 6 it happens in a way that everybody seems to be seeing 7 much the same thing. 8 Q. Okay. 9 A. And this is what I believe happened to 10 Mr. Forsyth. 11 Q. So we've got Teicher and Cole, these are the 12 Harvard guys, right? 13 A. Yes. 14 Q. We've got Rothschild, right? 15 A. We have. 16 Q. He's another Harvard fellow? 17 A. Yes. Yale is outgunned here, Mr. Vickery. 18 Q. I don't take a personal offense at it. That's 19 okay. And Yale is next, who's that? 20 A. That was King, I believe. 21 Q. Then we had -- 22 A. Wirshing. 23 Q. -- Wirshing and Van Putten, right? 24 A. That's right. 25 Q. Did you remember over the evening where those PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 910 1 guys are from? 2 A. I didn't check. I'm sure we could find that 3 quite easily. 4 Q. And, of course, Cole and Van Putten are both 5 very senior guys, aren't they? 6 A. You cannot be more senior. 7 Q. All right. And who else do we have? 8 A. Well, you've got an obscure person like me as 9 well, yes. 10 Q. So is the consistency of the observation of 11 this phenomenon by senior people published in 12 well-respected, peer-reviewed journals, something that 13 tends to suggest that there's a causal relationship in 14 the case of Mr. Forsyth? 15 A. Yes, it is. You not only have very senior 16 investigators, but there's little or no reason to 17 believe that any of them were copying each other. I 18 know, in our case, for instance, we were unaware of 19 the Teicher reports when we filed our reports. What 20 we filed on, and what I believe the Harvard guys all 21 filed on, was a clinical picture very, very similar to 22 what happened to Mr. Forsyth. 23 Q. Okay. Number four is called biologic 24 plausibility. That's a mouthful. Can you put it in 25 simple plain English for me? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 911 1 A. Yes, I can. What it means is if a drug appears 2 to be causing some problem of some sort, you would 3 want some physiological rationale, some mechanism to 4 appeal to. Now, we can appeal to the mechanism on two 5 levels. We can appeal to akathisia or nervousness, 6 drug-induced nervousness, being wired. We can 7 actually appeal to that as a mediating factor in 8 producing the effect, and the other thing then, which 9 would really be wonderful if we had it, would be if we 10 understood exactly what causes the wiredness. 11 Now, we've got some hints. The best theories 12 at the moment are that it's an interaction between the 13 serotonin and dopamine system, and that in particular, 14 drugs which release serotonin on to the serotonin 2 15 receptor may trigger this off, and Reserpine, which I 16 outlined to you at the start, and fluoxetine, which 17 both cause akathisia, both do just this. So this 18 biological plausibility, which is proven by the fact 19 that clinicians throughout the United States use a 20 drug which blocks the serotonin 2 receptor in order to 21 try and ameliorate this particular problem. 22 Q. Okay. Let me try plain English. Does it mean, 23 biologic plausibility, that there is just a simple 24 logical, physical reason to explain why this happens 25 and how it happens? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 912 1 A. Yes. What it means is if you've got something 2 happening and no one can understand why it's 3 happening -- for instance, there used to be a problem 4 with the MAOIs that when you ate -- well, it appeared 5 that when you ate cheese, that you were at risk of 6 having a stroke. No one really believed this was 7 happening from the studies that were done until people 8 were able to pinpoint the mechanism by which this was 9 happening. Once they pinpointed the mechanism, every 10 one believed it happened. 11 In the same case we are now at the point where 12 we have a mechanism by which akathisia happens and we 13 know that fluoxetine is a drug that acts on this 14 mechanism. 15 Q. Okay. So the biologic explanation that you 16 have for why Mr. Forsyth -- why you believe that 17 Prozac caused him to do these things is akathisia? 18 A. Yes. 19 Q. Well, let me come back to something that I'm 20 sure Mr. See may ask you about. Don't you have to 21 have visible pacing, tapping, squirming for a person 22 to have akathisia induced by fluoxetine? 23 A. Absolutely not. As the Lilly database itself 24 shows, they called this phenomenon as nervousness. 25 I've explained to the jury and to the Court earlier PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 913 1 that the best hunch or the best way to get an insight 2 on this is the notion of being wired by too much 3 coffee. This gives you a hint of what the problem is 4 like. 5 It can be much, much worse than that, but if 6 you were wired with too much coffee, you'd have to let 7 us know that you are actually pacing around more than 8 was usual for you or I'd have to ask you questions in 9 great detail before I know this was a fact. 10 Q. Well, let me ask you this: We'll kind of put a 11 footnote that I may or may not have to come back to on 12 the redirect examination. Footnote, is there a 13 difference between akathisia that is induced by Prozac 14 in something called neuroleptic-induced akathisia? 15 A. Yes, there is, and I would hope to illustrate 16 this before the end. I can read some quotes for you 17 if you like. 18 Q. No, let's don't do that. We'll leave that to 19 Mr. See. 20 A. There is a difference. There is a difference. 21 Q. Okay. That's number four. Number five is a 22 consideration of alternative explanations. Now, is 23 there a process that doctors do with live patients 24 called a differential diagnosis? 25 A. There is, yes. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 914 1 Q. And if I come to you and I have a problem, do 2 you typically, in order to figure out what's wrong 3 with me, establish, in your own mind, a differential 4 diagnosis? 5 A. Yes, I do. 6 Q. What is it? 7 A. What this means is I would look at the three or 8 four options that could be involved here. I might, 9 early on, have them in order in my own mind. Well, 10 this is the most likely, then this, then this, then 11 this. Then we would do other kinds of tests to try 12 and work out which option actually applies in your 13 case. 14 Q. Now, you can't do that with someone who's not 15 alive, right? 16 A. That's absolutely true. 17 Q. But is there a similar procedure that is used 18 as you consider the case of Mr. Forsyth to say, is 19 there something else that can account for this? Is 20 there something else to explain why he would do this 21 if not the Prozac? 22 A. Yes. And the obvious one in this case is you 23 would want to look at the fact, did his being 24 depressed cause him to do this? And I looked very, 25 very closely at this. I looked through the record, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 915 1 and for my money, Mr. Forsyth was only mildly 2 depressed. And I've shown you that the risk of 3 suicide with this particular condition should be 4 almost zero. 5 Now, there's more to it than that. 6 Mr. Prozac -- Mr. Forsyth not only killed himself, but 7 killed his wife as well. So you would look at the 8 suicide/homicide literature and see, well, is this 9 particular case typical of what normally happens there 10 and there's been some -- well, there's a good recent 11 article in the American Journal of Psychiatry which 12 looks at this, in particular, in elderly people. The 13 issue hasn't -- well, I hope I'm not actually 14 offending anyone here by using the word -- 15 MR. SEE: If you could stop just one second, 16 Dr. Healy. I object. It's beyond the scope of his 17 report, Your Honor. 18 Q (By Mr. Vickery) Don't go into this recent 19 article. Just tell us, did you consider the 20 possibility that depression would account for it in 21 Mr. Forsyth's case? 22 A. I consider it very strongly, and the nature of 23 the suicide and the nature of the suicide/homicide 24 here was inconsistent with the literature on 25 depression-induced suicide or depression-induced PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 916 1 suicide and homicide. 2 Q. Okay. And did you also consider whether or not 3 this was, I believe the words -- they're not on that 4 chart -- but was the classic case of a 5 homicide/suicide? 6 A. No, this is not the classic case of a 7 homicide/suicide. 8 Q. Did you consider that though and think about 9 it, that possibility, and reject it? 10 A. Yes, I did. 11 Q. Why? Was there something about the manner of 12 death that caused you to reject it? 13 A. Absolutely. We know that older people, where 14 the husband -- usually the husband kills the wife, so 15 that bit would be consistent with it, but we know that 16 usually what's happening is -- 17 MR. SEE: Your Honor, I object. It's beyond 18 the scope of the witness' report. 19 MR. VICKERY: It certainly isn't. I'll be glad 20 to read the Court that section of the report right 21 here. 22 THE COURT: Well, let's break for lunch now. I 23 want to meet with counsel. Please be back at one 24 o'clock. 25 (Whereupon, the following proceedings were had PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 917 1 in open court out of the presence of the jury.) 2 THE COURT: Mr. Vickery. 3 MR. VICKERY: May it please the Court, Your 4 Honor -- 5 THE COURT: You may step down. 6 MR. VICKERY: I'm trying very diligently to 7 adhere to the Court's order. The following sentence 8 appears in Dr. Healy's report. 9 THE COURT: What page? 10 MR. SEE: What page, please? 11 MR. VICKERY: This is on Page 3 in the 12 paragraph down at the bottom. "The ferocity of these 13 events is not consistent with a simple premeditated 14 disposal of his wife on the basis of marital 15 disharmony, nor is it typical of the suicides or 16 homicides that occur in depressive disorders, but in 17 my experience, akathisia, whether caused by Prozac or 18 other drugs, can produce this proportionally violent 19 impulses and actions." It's right there in his 20 report. 21 MR. SEE: The reference that I'm searching for, 22 Your Honor, and I can't find it as I stand here this 23 second, I asked Dr. Healy this question in his 24 deposition: Doctor, are you aware that there is a 25 body of literature about the combined event, homicide PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 918 1 followed by suicide? His answer, yes. 2 Question: Have you looked at any of that? 3 Answer: No. 4 So now for the witness to get on the stand and 5 say, oh, by the way, here's what I find in all this 6 literature, grossly unfair. I object to it. 7 MR. VICKERY: Now, Judge, Mr. See can't have it 8 both ways. He can't say to Your Honor, please confine 9 him to his report and don't let him supplement his 10 report in his deposition, and then when I show the 11 Court where it is right in his report, and then say, 12 but he didn't tell me that in his deposition. 13 I'm sure that one of the reasons Dr. Healy went 14 to study this literature after his deposition was 15 probably because he knew Mr. See was interested in it 16 and wanted an answer to it. He can't have it both 17 ways. 18 MR. SEE: The descriptive term for that, with 19 great respect to counsel is, sandbag, and that ought 20 not to be permitted. 21 THE COURT: I'll allow you to cross-examine him 22 on that, Mr. See. I will allow the question. 23 MR. SEE: Very good. 24 THE COURT: You had another matter that you 25 wanted to bring up? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 919 1 MR. SEE: We did, Your Honor. There -- I 2 believe we'll get to her this afternoon. The former 3 employee of Lilly, a lady by the name of Amy Lee who 4 was a Lilly representative, who called, for a very 5 short time, on Dr. Roberts, I think -- 6 THE COURT: Called on Roberts? 7 MR. SEE: She called on Dr. Roberts as a Lilly 8 representative. 9 THE COURT: Oh. 10 MR. SEE: About how long? Three months? Four 11 months? About three or four months just prior to this 12 event, and she's been subpoenaed by the plaintiff and 13 will be here to testify. The issue is, there are -- 14 and again, I cannot anticipate what Mr. Vickery may 15 have in mind, but I think what he may have in mind is 16 taking internal Lilly documents that this young lady 17 has never seen, would never have any cause to see 18 because they were way before her time or were internal 19 company documents that she would have absolutely no 20 knowledge of and put them in front of her and say, 21 well, did you know that? Well, why didn't you know 22 that? And so on. 23 I think that Rule 602 is very clear that if a 24 witness doesn't have personal knowledge about a 25 matter, then they ought not testify about it. And PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 920 1 with -- and again, I don't know if he's going to do 2 that or not, but with respect to documents that 3 clearly were before her time or that were back in 4 Indianapolis, that she would have no knowledge about, 5 there's no point to be served, and, in fact, is 6 improper under Rule 602 to try to use her by sticking 7 the document under her nose and saying, well, what do 8 you think about that? Isn't that horrible? Didn't 9 you want to know that and so on? 10 So I'm raising it at this time that the 11 plaintiff ought not be able to try to make play of 12 documents that the witness will not have any knowledge 13 about. All she'll do is say, I've not seen that. I 14 don't know. 15 THE COURT: Mr. Vickery. 16 MR. VICKERY: With respect, Your Honor, it is 17 difficult to believe that I just heard that from 18 someone who had accused me of sandbagging. The 19 dilemma that we face in trying to prove our case is 20 that, you know, we are here in Hawaii. We have access 21 only to those people that we can compel by subpoena 22 here in Hawaii. The Court knows we tried mightily to 23 get Dr. Beasley, who obviously has knowledge, who 24 obviously is the key player, but Lilly keeps him back 25 in Indianapolis and says, ah-ha, you can't make him PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 921 1 come. 2 We have this woman who is the only marketing 3 person within the subpoena range of the Court and have 4 her here to come so that we can ask her what kind of 5 instructions she was given about warning doctors or 6 responding to their questions about Prozac-induced 7 violence. That's all we have access to from Eli 8 Lilly. They can bring whoever they want -- 9 MR. SEE: If those are the questions, then 10 those are proper questions. 11 MR. VICKERY: So anything that predates any 12 information that Lilly had, whether she knew it or 13 whether they withheld it from her, if it predates the 14 time of this incident, she should have been told. 15 They can't simply keep their sales force in the dark 16 and then -- and not give them information and then 17 when you -- 18 THE COURT: You can ask her about what she was 19 aware of, but you can't ask her to testify as to 20 things she had no knowledge of. 21 MR. SEE: Your Honor, there are cases right on 22 this that say it's improper to use a witness simply to 23 read a document to the jury. 24 THE COURT: I'll sustain Mr. See's objection as 25 to that. We'll meet at one o'clock. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 922 1 (Whereupon, a lunch recess was taken from 2 12:03 p.m. to 1:10 p.m.) 3 THE COURT: Please proceed, Mr. Vickery. 4 MR. VICKERY: Thank you very much, Your Honor. 5 Q. Dr. Healy, we were talking before about the 6 fifth Bradford Hill criteria, consideration of 7 alternative explanations. 8 A. Yes, Mr. Vickery. 9 Q. Did you consider and reject the possibility 10 that either depression or the classic homicide/suicide 11 phenomenon would account for the deaths of the 12 Forsyths? 13 A. I did. 14 Q. Let's look at the sixth one, specificity of the 15 association. What's that about? 16 A. The specificity of the association looks at 17 whether the particular drug in this case, for 18 instance, would only cause this particular problem or 19 could it cause other problems, and you're looking at 20 whether there's a one-to-one relationship between the 21 drug or the event or whatever and the consequence that 22 you're interested in. 23 Now, of course, a drug could have a specific 24 relationship to the consequence that you're interested 25 in, but do other things as well, and indeed, it could PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 923 1 be the case that there might be more than one 2 mechanism by which the drug leads to the consequence 3 that you're interested in, and while akathisia, I 4 think, has to be the leading mechanism in this case, 5 there are other aspects of Prozac's action which would 6 need to be taken into account and are consistent with 7 what happened. 8 Q. Okay. Now, let's look at number seven. Dose 9 response relationship. Let me write it and then I'll 10 ask you to tell us what it means. Can you tell us 11 what a dose response relationship means and how, in 12 any way, that is pertinent to the question of whether 13 this drug caused this man to kill his wife and then 14 himself? 15 A. Yes. The dose response relationship between 16 the intake of a drug and the consequence of having had 17 it is the most important law in all of pharmacology, 18 and basically, what it's saying is that if you take -- 19 it's like a bit like tea or coffee. If you take a 20 small amount of tea or coffee, it will wake you up a 21 bit. If you take more, it will wake you up more. And 22 there's a curve where increasing dose will give more 23 of the consequence until you hit a point where things 24 may change. 25 Q. Is that sort of like the example you used PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 924 1 yesterday of me drinking a little bit of gin versus 2 drinking a lot of gin? 3 A. It is, yes. 4 Q. And what is the evidence in the published 5 literature regarding Prozac and its dose response, 6 vis-a-vis causing akathisia? Tell us -- 7 A. Well, it is good -- 8 MR. SEE: Dr. Healy, one moment please. I 9 object and ask that we can approach? 10 THE COURT: Okay. 11 (Whereupon, the following proceedings were had 12 at side bar out of the hearing of the jury.) 13 THE COURT: We're spending more time over here 14 than we are in hearing testimony. 15 MR. SEE: Your Honor, I believe that this is an 16 area of testimony that the Court has already, 17 essentially, ruled out of the case. The testimony is 18 that there is no evidence whatever that this man 19 suffered any adverse consequences as a result of 20 taking too much Prozac. In other words, that the dose 21 was too high. 22 Now Dr. Healy is going to be talking about that 23 high doses are more dangerous and high doses cause 24 akathisia, where the fact is, there wasn't a high 25 dose. He had the normal dose and no expert on either PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 925 1 side says that this man suffered any adverse 2 consequence at all because of taking a high dose of 3 Prozac. So it's not relevant and it is very 4 prejudicial. 5 THE COURT: It is not relevant, is it? 6 MR. SEE: It is very prejudicial because it 7 didn't happen to this man, and Dr. Healy will say if 8 you take a lot of it, then that does cause the event. 9 Well, this man didn't take a lot of it. He didn't 10 take a high dose. 11 MR. VICKERY: First of all, this is not the 12 dose issue the Court ruled on. The dose issue the 13 Court ruled on is whether we should be permitted to 14 bring out the fact that shortly before Mr. Forsyth got 15 Prozac, they offered him a 10-milligram tablet, and 16 the Court said don't bring it out. 17 THE COURT: I don't think Mr. See is saying 18 that. 19 MR. SEE: I didn't say that. 20 MR. VICKERY: Well, he said the Court already 21 ruled on it. That's the only dose issue that the 22 Court ruled on. And secondly, nobody is going to say 23 that Mr. Forsyth had too high of a dose, and in fact, 24 if that's his concern, I'll bring that out. What is 25 important about it, as you analyze the causality PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 926 1 issue, is to know that this phenomenon occurs more 2 frequently or with greater intensity than a higher 3 dose, then that's evidence that the drug is -- 4 THE COURT: Higher dose? 5 MR. VICKERY: I think that Dr. Healy's 6 testimony will be that there -- the published 7 literature establishes that it has happened with 8 higher doses, 40 milligrams, 60 milligrams than with a 9 20-milligram dose, so that's that fact alone. I'm not 10 saying that Mr. Forsyth had too much. I'm not saying 11 that at all. I'm saying the fact that the phenomenon 12 is connected to the dose is indicative to the drug is 13 causing it. I hope I said that in a way -- 14 MR. SEE: But his question asked specifically 15 about Mr. Forsyth. That's how it led into the area. 16 The reason it's prejudicial is, a lot causes this 17 problem, then, I guess, a little might, too. And 18 that's the danger and prejudice. 19 THE COURT: I'll allow it if you bring up the 20 fact that that's not an issue in this case and 21 Mr. Forsyth was taking the normal -- within the normal 22 MG dose. 23 MR. VICKERY: Okay. 24 THE COURT: Okay. 25 (Whereupon, the following proceedings were had PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 927 1 in open court in the presence of the jury.) 2 Q (By Mr. Vickery) Dr. Healy, do you understand 3 that in this case that Mr. Forsyth was taking a 4 20-milligram dose and that we do not have any 5 challenges regarding the dose he was taking? We're 6 not saying it was too high or anything like that? Do 7 you understand that? 8 A. I do, indeed. 9 Q. Now, is there something about the fact -- is 10 there something in the public literature to indicate 11 that this phenomenon, the akathisia is sensitive to 12 changes in dose? 13 A. There is. If you look at the Wirshing case 14 series, you clearly see that some people who were on a 15 20-milligram dose, when they went up to a 40-milligram 16 dose, the phenomenon appeared. When they went back 17 down to 20, the phenomenon went away again. This is a 18 very strong dose-relationship indication. 19 In Mr. Forsyth's case, in particular, we have 20 some evidence from the fact that he appears to have 21 gone on Prozac and may have halted it for a day or two 22 after he went into the hospital -- this is a little 23 less clear -- during which time he may have been 24 slightly less distressed and then he goes back on the 25 drug. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 928 1 But the dose response relationship itself may 2 give you a good idea as to why this phenomenon 3 happened something like ten days into the course of 4 treatment because there's a very long half life to 5 this drug, Prozac, and it builds up in the system, so 6 you're not on the same dose the whole time. It's 7 building up in your system, and there comes a point, 8 and this seems to be what happened -- this was the 9 kind of consideration that led me to implicate Prozac 10 in the case of Mr. Forsyth's death, that it happened 11 around the time that the dose had been building up in 12 his body. 13 Q. Okay, sir. Number eight is experiment, right? 14 Now, what is that? Had there been some test/retest, 15 challenge/rechallenge? Is that what we're talking 16 about when we talk about experiment? 17 A. Yes, it is. As opposed to me simply having to 18 rely on the details of the case in Mr. Forsyth's case, 19 I'm able to appeal to the fact that other 20 well-conducted studies have been done on this issue 21 and they provide data consistent with the opinion that 22 I'm coming to in his case. 23 Q. These studies that you talked about involving 24 challenge, dechallenge, rechallenge, are these case 25 reports or anecdotal reports or are they some other PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 929 1 kind of scientific article? 2 A. These are not case reports or anecdotal 3 reports. These are controlled clinical studies done 4 to the highest standards. 5 Q. And the final one is analogy. Analogy. What's 6 an analogy? 7 A. Well, it's this: If you're looking at a 8 particular phenomenon, you would be reassured if 9 something similar to that phenomenon had happened and 10 had been reported on before and had been generally 11 agreed upon before, and in this case, there is a 12 compelling similarity between what happened to 13 Mr. Forsyth, and what happens, I believe, with Prozac 14 for some individuals, and something that has happened 15 before. 16 Q. Okay. Let's set the foundation for this. Did 17 the something that happened before involve a drug 18 which operates on the serotonin system? 19 A. The something that happened before involved an 20 antidepressant active in the serotonin system. 21 Q. Did the something that happened before involve 22 akathisia? 23 A. The something that happened before involved 24 akathisia. 25 Q. Did the something that happened before involve PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 930 1 a drug which influenced the serotonin system and 2 caused akathisia which then led to suicide? 3 A. It did, Mr. Vickery, and the significance of 4 what happened is particularly important, and I would 5 like to outline, if I could, to you what's involved. 6 Q. I want to get to it. I want to lay my 7 foundation first. 8 A. All right. 9 Q. Now, Dr. Healy, did the something that happened 10 before involve depression? 11 A. No, it didn't, Mr. Vickery, and this is the 12 critical point. 13 Q. Okay. Let me write that in a different color. 14 Give us the analogy. What happened and what's the 15 significance of it? 16 MR. SEE: Your Honor, I'm going to object to 17 the question and again ask to approach? 18 THE COURT: All right. The jury will excuse 19 us. 20 (Whereupon, the following proceedings were had 21 at side bar out of the hearing of the jury.) 22 THE COURT: What is it now? 23 MR. SEE: What it sounds like Mr. Vickery is 24 going to try to put in evidence there is some drug, I 25 don't know what he's talking about, a drug that causes PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 931 1 akathisia that results in suicide, not Prozac, but 2 something else that's completely irrelevant. That 3 some other drug has that effect has nothing to do with 4 whether Prozac has the effect. It is guilt by 5 association, and it is the most unfair kind of 6 evidence. He's trying to tar Prozac with some other 7 drug. 8 MR. VICKERY: I'm not trying to do that at all. 9 What I'm trying to do is respond to the defense's 10 contention raised by Mr. See in his opening statement, 11 this is a good drug. This is a case about a good drug 12 and a very bad disease. What I intend to show is if 13 you take -- if you have a drug that causes akathisia, 14 and if you take depression out of the equation, it 15 still leads to suicide, and that tends to respond 16 directly to the defense's theory, oh, it's not the 17 drug. It's not the drug. It's the underlying 18 disease, and it's applicable analogy. 19 He can cross-examine if he wants. If he wants 20 an instruction by the Court -- this is just an 21 analogy. 22 THE COURT: What's the drug? 23 MR. VICKERY: Reserpine. 24 THE COURT: Huh? 25 MR. VICKERY: Reserpine. In this country we PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 932 1 pronounce it Reserpine. It was a drug that was an 2 antidepressant for the serotonin system that caused 3 akathisia and suicide in non-depressed people, and 4 that fact is very compelling evidence that Mr. See is 5 on very shaky ground when he says it's the underlying 6 disease. 7 MR. SEE: You almost wonder what case he's 8 trying. I request 403 analysis. What he's trying is 9 Prozac, but the evidence he's putting on has to do 10 with a completely different drug not related to 11 Prozac, not like Prozac at all. It is completely 12 prejudicial and invites the jury to think that if one 13 drug does it, then this one must too. That's the 14 reason he's going for it and that ought not be 15 permitted. It is totally unfair. 16 THE COURT: I'm not going to allow it under 17 403. I find that highly prejudicial and more, 18 prejudicial giving rise to unfair prejudice as quoted 19 in the statute, and it would confuse the jury. This 20 is another drug. 21 (Whereupon, the following proceedings were had 22 in open court in the presence of the jury.) 23 Q (By Mr. Vickery) Dr. Healy, considering all 24 nine of the Bradford Hill factors that we've 25 discussed, do you believe that Prozac was a PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 933 1 substantial factor in the deaths of June and Bill 2 Forsyth? 3 A. Yes, I do, Mr. Vickery. I think it is the 4 factor without which I am as certain as one could be, 5 that this man would not have committed suicide and 6 would not have killed his wife. 7 Q. One final question and I'll allow Mr. See to 8 question you a while. In your travels to all of these 9 places that you've gone and given speeches on this 10 topic, is Prozac used in all of those places? 11 A. No. Prozac is not used worldwide. It's not 12 used in large parts of the world because it's too 13 expensive, but in particular, it's not used in Japan. 14 It's not on the market in Japan. It does not have a 15 license in Japan, and from being in Japan and talking 16 to the issues that you've heard me talk about in the 17 court today, I thought I was going to surprise my 18 Japanese colleagues, but they surprised me by saying 19 well, they were aware -- 20 MR. SEE: Your Honor, I'm sorry. I object. 21 Hearsay. 22 THE COURT: Sustained. 23 MR. VICKERY: I'll pass the witness. 24 THE COURT: Your turn, Mr. See. 25 MR. SEE: Thank you, Your Honor. Your Honor, I PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 934 1 have some literature that I may ask Dr. Healy about. 2 May I put the notebook in front of him so he would 3 have ready reference to them? 4 THE COURT: You may. 5 CROSS-EXAMINATION 6 BY MR. SEE: 7 Q. Doctor, I may ask you about one of these. I'll 8 let you know when that comes up. Don't be concerned 9 about it until we do. 10 A. Okay. Thank you. 11 MR. VICKERY: I would only request of the 12 Court, that if this is literature that's not marked as 13 an exhibit, that we also have a copy of it as well. 14 THE COURT: Sounds fair enough. 15 MR. VICKERY: If I may, Your Honor, I'd like 16 the opportunity to sort of thumb through these things 17 as he's asking. If they are things that are not 18 premarked as exhibits, I'd like to have some 19 opportunity to look at them so I can know whether they 20 are objectionable or not before Mr. See asks him. 21 MR. SEE: This is medical literature, Your 22 Honor. It's published. I'm just going to ask 23 Dr. Healy, if he's looked at it, considered it, taken 24 into account. I'd be happy to hand Mr. Vickery a 25 copy, each one as they come up. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 935 1 THE COURT: Let's proceed. 2 Q (By Mr. See) Good afternoon, Dr. Healy. 3 A. Good afternoon, Mr. See. 4 Q. I should say welcome to the United States. 5 A. Thank you very much. 6 Q. And in particular welcome to this side of the 7 world. 8 A. Well, I'm thrilled to be here. Not under these 9 circumstances. 10 Q. Yes, sir. You've come a long way traveling to 11 Honolulu to testify here? 12 A. I have. 13 Q. Of course, you're being compensated for your 14 time, working on the case, traveling here and 15 testifying? 16 A. I am. 17 Q. What does that work out, traveling all the way 18 here from Wales and so on? 19 A. Well, to date, over the course of two years, I 20 think, for a very large amount of work, I've been paid 21 something like $15,000. Approximately, I've been paid 22 nothing for being here today so far. 23 Q. You would contemplate that you would be 24 compensated for coming all the way here? 25 A. I think there's a chance that I will see some PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 936 1 compensation, yes. 2 Q. Good for you. Now, Dr. Healy, this afternoon 3 we're going to proceed by just a slightly different 4 method. I am actually going to be asking you 5 questions and then you will give me the answer to my 6 question. Are you willing to do that? 7 A. Yes. 8 Q. Now, you've testified yesterday and today about 9 a condition called akathisia. 10 A. I have. 11 Q. And particularly, you gave testimony on your 12 view that you actually had patients that had 13 akathisia, but you couldn't see it and you missed it. 14 Do you recall that? 15 A. I do. 16 Q. Would you turn to tab two in your book, please. 17 Tab two is a declaration that you gave in this case, 18 right? 19 A. Yes. 20 Q. And you see your signature there on Page 41? 21 A. I assume it's there. 22 Q. It is the last page. 23 A. I trust you that it is. 24 Q. The last page. 25 A. Yes. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 937 1 Q. And that was dated the 5th of October of 1997, 2 correct, sir? 3 A. It is correct. 4 Q. And when you made this declaration it says here 5 that you declare under penalty of perjury, that's what 6 it says there? 7 A. It is, yes. 8 Q. So you understood that you were under oath to 9 tell the truth? 10 A. Absolutely. 11 Q. And you understood that the declaration would 12 be submitted to the Court in this case, right? 13 A. I'm not sure I understood that, Mr. See. This 14 is the first court case of this sort that I've been 15 involved with. 16 Q. Let me ask you this way: You did realize that 17 when you signed the declaration under penalty of 18 perjury, you needed to tell the truth and it was a 19 pretty important matter? 20 A. Absolutely. 21 Q. Now, would you turn please to Page 5 of your 22 declaration on Paragraph 17. Are you there? 23 A. I am, yes. 24 Q. I want to ask you about the second sentence of 25 that paragraph, and I want to read it to you and then PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 938 1 ask you a question about it. This is what you wrote: 2 "The emergence and clearing up of akathisia is a much 3 more visible and clear-cut phenomenon and much less 4 subject to spontaneous variation than the emergence 5 and resolution of a depressive disorder." That's what 6 you wrote? 7 A. That's what I wrote. 8 MR. VICKERY: Excuse me, Mr. See. Objection, 9 Your Honor. Under Rule 106, I submit in fairness, the 10 entire paragraph is necessary to put this statement in 11 context. 12 MR. SEE: With respect, Your Honor, if 13 Mr. Vickery wants to bring it back on redirect, I 14 would have no objection to that, but I have a point to 15 make and it gets lost if you read the whole thing 16 straight through. 17 THE COURT: I direct you to read the rest of 18 the paragraph. 19 MR. SEE: All right. 20 Q. And let me go on with the paragraph -- 21 MR. VICKERY: Well, excuse me, Counsel. Would 22 you start at the first sentence? 23 MR. SEE: Oh, sure. I'd be happy to. 24 Q. You write, "In the case of side effects such as 25 suicidal ideation and akathisia induced by Prozac, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 939 1 clinical trials are not necessary. The emergence and 2 clearing up of akathisia is a much more visible and 3 clear-cut phenomenon, and much less subject to 4 spontaneous variation than the emergence and 5 resolution of a depressive disorder. In terms of 6 whether clinical trials are needed or whether case 7 reports will suffice, the facts outlined above need to 8 be considered. One factor is the clarity of the 9 outcome being considered. 10 "In the case of strychnine and activated 11 charcoal, the end point is so clear-cut that there can 12 be no doubt about the answer. The same applies to 13 falling asleep 30 seconds after an anesthetic. 14 Akathisia similarly is a clear-cut phenomenon. It is 15 extraordinarily rare naturally. It's occurrence 16 following drugs is so well-established that no 17 investigator has ever felt the need to conduct a 18 randomized placebo-controlled trial to establish this 19 fact. 20 "Further references regarding single event 21 trials are Tergi Johanson, controlled trials in single 22 subjects, British Medical Journal, Volume 303, 30 July 23 1991; Alan E. Casdin, single case research designs, 24 Oxford University Press, New York, 1982; and then 25 there's a parenthetical and it says, Exhibit 1B." PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 940 1 Have I read that correctly, that paragraph? 2 A. You have, Mr. See. 3 Q. And you wrote that under penalty of perjury? 4 A. I did, indeed. 5 Q. I'd like to ask you about the several articles 6 that you discussed with Mr. Vickery and that he has 7 listed here, Teicher, Rothschild, King, Wirshing, and 8 David Healy. Do you recall those? 9 A. I do. 10 Q. And I believe you just testified to the jury 11 that these articles were not case reports, right? 12 A. These are controlled studies. 13 Q. Would you turn to tab 35 in your book, please? 14 A. I would be happy to. 15 Q. Tab 35 is a copy of the Teicher paper, correct? 16 A. Not here. Yes. I had the one before the tab. 17 All right. 18 Q. You have the Teicher paper now? 19 A. I have the Teicher paper now. 20 Q. I'd like to ask you to look at the heading in 21 the second -- in the left-hand column, if you would 22 please, and there -- the left-hand column on the first 23 page of the article, and there it says, "Case 24 reports;" isn't that right? 25 A. It is. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 941 1 Q. Now, would you turn to tab 33, and that is the 2 paper by Dr. Rothschild, correct? 3 A. That is correct. 4 Q. Now, I'd like you to refer to the heading in 5 the right-hand column, and it says there, "Case 6 reports," correct? 7 A. That is correct. 8 Q. Now, if you would turn to the front pocket of 9 the book, it's not actually in the rings, but there 10 should be a separate copy of the King paper. Do you 11 see it? 12 A. I do. 13 Q. All right. If you look at the second page of 14 the King paper it says there, "Case report," right? 15 A. That is correct. 16 Q. You want me to go on to the rest? They say 17 case report, too, don't they? 18 A. They do. 19 Q. Let me move this up so we'll have a little 20 clearer view. I want to show you, Dr. Healy -- let me 21 hold it up this way first -- an excerpt from your 22 article called, "The Fluoxetine and Suicide 23 Controversy." 24 A. Yes. 25 Q. "By David Healy, A Review of the Evidence." PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 942 1 A. That's right. 2 Q. Now, first I'd like to ask you this: You made 3 some comments and some testimony about a study done by 4 a Dr. Charles Beasley earlier on today, right? 5 A. That is correct. 6 Q. And there's a reference here to Beasley in this 7 excerpt. That would be one in the same Dr. Beasley? 8 A. It would be. 9 Q. And your reference in this excerpt is to the 10 meta-analysis done by Dr. Beasley? 11 A. It is, indeed. 12 Q. My question is, did you write, "In reply to the 13 case reports of fluoxetine" -- that's Prozac, right? 14 A. That's Prozac. 15 Q. -- "fluoxetine-induced suicidality that Beasley 16 and colleagues scrutinized the Eli Lilly database for 17 evidence of increased suicidality in patients 18 receiving fluoxetine. No such evidence has been 19 found. These data from several thousand patients and 20 the evidence that fluoxetine reduces suicide ideation, 21 must on any scientific scale, outweigh the dubious 22 evidence of a handful of case reports." 23 Now, my first question for you is, that's what 24 you wrote in this article by David Healy, right? 25 A. Absolutely, correct. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 943 1 Q. Now, dubious, does that mean, what? 2 Unbelievable? 3 A. Dubious means you would have to think twice 4 before you believed it. 5 Q. Very good. Now, let me ask you about the 6 second excerpt here we have, also this highlighted 7 part from your article, and it says, "Case reports are 8 clearly an unreliable form of information." Have I 9 read that right? 10 A. You have. 11 Q. And you wrote that in this published article? 12 A. I did. 13 Q. Now, I would like to ask you, Dr. Healy, if I 14 might, some questions about the facts concerning 15 William and June Forsyth. The first thing I'd like to 16 ask you is this: At the time that you formed your 17 opinion that Prozac caused the deaths of Mr. and 18 Mrs. Forsyth, you had examined a series of notes that 19 Bill Forsyth had taken prior to his death? 20 A. Yes. 21 Q. And in those notes Bill Forsyth, as was his 22 habit, wrote down plans or what he was doing or what 23 he was thinking about; isn't that right? 24 A. It is. 25 Q. And it is your view, is it not, that there is PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 944 1 nothing significant contained in Mr. Forsyth's notes, 2 at least as it relates to the cause of his and his 3 wife's death? 4 A. Yes. That is correct. 5 Q. You were not influenced by Bill Forsyth's notes 6 in forming your opinion? 7 A. It's very hard to say, Mr. See, exactly what 8 influences you. I reviewed a very large amount of 9 evidence in a very short period of time, and I know I 10 came to a conclusion, but I couldn't put a weight on 11 just what bits of the information influenced me to 12 what extent. 13 Q. Would it be correct to say that there was 14 nothing significant one way or the other that leapt 15 out to you from Bill Forsyth's notes? 16 A. I cannot clearly answer that for you. It's 17 almost two years since I read that particular piece of 18 the evidence. 19 Q. To you, Bill Forsyth's notes just looked like a 20 normal set of jottings? 21 A. Yes, largely. 22 Q. Now, with respect to Mrs. Forsyth, June 23 Forsyth, as you reviewed the materials and formed your 24 opinion in this case, Mrs. Forsyth did not appear to 25 you to have any significant psychiatric problems; PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 945 1 isn't that correct, sir? I'm talking about at the 2 time you formed your opinion. 3 A. That is correct. 4 Q. And when you formed your opinion as far as you 5 knew, June Forsyth had no psychiatric condition which 6 affected the marital relation, she with her husband, 7 right? 8 A. That is correct. 9 Q. You will agree that before he ever took Prozac, 10 Bill Forsyth had a problem with the condition anxiety? 11 A. I agree that he appeared more anxious than he 12 had been before in his life, yes. 13 Q. And would you agree that before he ever took 14 Prozac, just because of his personality, that Bill 15 Forsyth was the kind of person who could be said to 16 have a controlling personality; that is, he wanted to 17 be in charge? 18 A. I didn't particularly get that from the record, 19 no. 20 Q. Would you agree, based upon your understanding 21 of the facts of the case, that the religious 22 activities and religious orientation of the Forsyth 23 family, and especially of June Forsyth, caused stress 24 on Bill Forsyth the last six months or so of his life? 25 A. Mr. See, as I read the record, I think Bill and PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 946 1 June Forsyth were in the position of working out where 2 they were going with their life, as all of us are 3 regularly, and you can't do this in a completely 4 stress-free way, but there's a difference between that 5 kind of stress and any stress disorder. And I would 6 like to make a very clear distinction between the two 7 and say that there was no stress disorder here. 8 Q. I didn't really ask you about that, so I'll try 9 again. Would you agree that the religious activities 10 of June, his wife, and Bill, his son, were a 11 significant stressor in Mr. Forsyth's life during the 12 last six months? 13 A. As you're phrasing the question, it is so 14 ambiguous, Mr. See, that I cannot give you a yes or no 15 answer. 16 Q. Well, isn't it correct that when I asked you 17 that question at the time of your deposition, you 18 answered me with a no? 19 A. I can't remember what I said to you at the time 20 of my deposition. If you say to me that that's what I 21 said, then I'm happy to agree with you. 22 Q. Would you agree that Bill Forsyth, Sr. felt 23 pressured by his family to enter into their 24 Christian-oriented lifestyle, again, in the last six 25 months of his life? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 947 1 A. I would agree with you that Bill Forsyth was 2 doing a considerable amount of thinking about his life 3 and clearly -- he was paying heed to what his family 4 was actually saying to him. If you say to me, he felt 5 clearly pressured by his family, again, you would have 6 to distinguish between normal pressure and abnormal 7 pressure, and I don't believe there was abnormal 8 pressure here. 9 Q. Again, let me refer you to the time that you 10 formed your opinion that Prozac caused the deaths of 11 these two people, at that time, did you know and would 12 you agree that June Forsyth's changing role in the 13 marriage to become a more independent person, more of 14 an equal partner, instead of the traditional 15 subservient wife's role, would you agree that that 16 change in June was a stressor on Bill Forsyth, again 17 during the last six months or so of their lives? 18 A. If you're referring to an abnormal stressor, 19 then no, I wouldn't. I think it was an opportunity 20 for growth for the two of them. 21 Q. And would you agree -- 22 THE COURT: Mr. Vickery, can you read what is 23 being written down there? 24 MR. VICKERY: No, Your Honor. Thank you for 25 asking. I couldn't. I was going to get up and check PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 948 1 it later. 2 MR. SEE: By all means. There's no question 3 pending. I'm sorry. 4 THE WITNESS: I think my statement has been 5 misrepresented. 6 Q (By Mr. See) All right. Let's do it right. 7 What should I say? 8 A. I think in the case of pressure and stressor, 9 you must distinguish between normal and abnormal 10 stressors and pressures and I have not conceded. I 11 haven't said that there isn't some stress, there isn't 12 some pressure, but I have said there is nothing 13 abnormal. I think you should include the word 14 abnormal to get an accurate representation of what 15 I've just said. 16 Q. Does that go to religious activity and June's 17 changing role? 18 A. Yes. 19 Q. So your testimony then would be, in your view 20 that was not an abnormal stressor? 21 A. That's my testimony. 22 Q. All right. Sir, thank you. 23 A. Could I quickly interpose one more point, 24 Mr. See? You may choose to disallow it. 25 Q. We're going to try to go with me asking PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 949 1 questions and you giving answers, if that's okay? 2 A. Okay. I'm sorry. 3 Q. Now, would you agree that before Bill Forsyth 4 ever took Prozac, he underwent a personality change as 5 observed by his own family? 6 A. No, I don't believe he did undergo a 7 personality change as observed by his own family. At 8 least if you're talking about to a psychiatrist -- 9 before you write the note, Mr. See. I think you 10 should listen to me through. 11 If you're talking to a psychiatrist, 12 personality change will mean one thing. If you're 13 talking to people generally in the street, personality 14 change -- for instance, if I were to fall in love -- 15 Q. I'm going to ask you a different question now. 16 A. Right. 17 Q. And maybe get rid of the problem. 18 A. Hopefully we will. 19 Q. Would you agree that before Bill Forsyth ever 20 took Prozac, he underwent a personality change as 21 observed and as described by his own family members? 22 A. I do not believe he underwent a pathological 23 personality change. 24 Q. I'll try this: Do you agree that Bill Forsyth 25 was described by his own family as having undergone a PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 950 1 personality change before he ever took Prozac? 2 A. Can I answer in this fashion, Mr. See? If I 3 was to fall in love, people who know me describe a 4 personality change. There would be nothing 5 pathological about this. If you're asking me did any 6 pathology appear, no, I do not believe that the family 7 observed any pathological personality changes. 8 This is very -- these words have very precise 9 meaning within psychiatry and it would be a mistake to 10 imply that lay words, in any way, map onto the 11 psychiatric use of these words. 12 Q. You understood my question was as described by 13 his family? You heard that part? 14 A. I heard that part. 15 Q. Didn't his family members say that he had a 16 changed personality way before he ever took Prozac? 17 MR. VICKERY: Excuse me. Objection, Your 18 Honor. That assumes facts not in evidence and in 19 fact, facts which are contrary to the testimony from 20 the only family member that's testified so far. 21 THE COURT: I don't think the son testified in 22 that fashion, did he, Mr. See? 23 MR. SEE: I'm asking Dr. Healy the question 24 based upon his thorough review of all the materials 25 he's looked at in the case. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 951 1 THE COURT: Which were different than what we 2 have heard in court? 3 MR. SEE: If he has reviewed them so, that's 4 what I'm trying to find out. 5 THE COURT: Well, ask him about what he 6 reviewed then. 7 Q (By Mr. See) Dr. Healy, based upon your 8 careful and thorough review of the materials that had 9 to do with this case, isn't it true that Mr. Forsyth 10 was described by his own family members as having 11 undergone a personality change before he ever took 12 Prozac? 13 A. Mr. See, as I recall the deposition between us, 14 and you may well have to check the wording, when faced 15 with that kind of question then and now, I take it 16 you're asking me to confirm that there has been a 17 personality change of the psychiatric kind in this 18 man. There hasn't been. The simple -- the lay use of 19 the word change of personality, encompasses the kind 20 of thing that happen to people when they fall in love. 21 Q. Okay. So for personality change, can I just 22 simplify it for you, and put no? 23 A. You can say that he has not had an abnormal 24 personality change. 25 Q. No abnormal change in your view. Do you agree PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 952 1 that in the last two or three months of his life, but 2 before the time he ever took Prozac, Bill Forsyth 3 exhibited a worried, panicky nature? 4 A. Not consistently, no. There were periods where 5 he may have been worried, but there were lengthy 6 periods, it seemed to me, from what I have read the 7 entire set of documents that I read, that he was not 8 unduly worried. 9 Q. So would your answer be sometimes? 10 A. Yes, he had periods of anxiety. 11 Q. Again, we understand all of this is before he 12 took Prozac? 13 A. Excuse me, Mr. See. You've misrepresented me 14 again. You included the word -- the word panicky. 15 Q. That's the question I asked. 16 A. Oh, well, perhaps I didn't hear it. This is a 17 very -- this is regarding which I would like to be 18 very careful. I'm happy to concede that Mr. Forsyth 19 had episodes when he was anxious. I would not like 20 you, if you can at all avoid it, to include the word 21 panicky. 22 Q. So should I put no? 23 A. Well, if you insist on including the word 24 panicky, which has a very different meaning between 25 the lay use of it and the psychiatric use of it, then PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 953 1 I think you may have to put no, but we'll need to bear 2 in mind that there's been a disagreement about the 3 meaning of what you asked me. 4 Q. My question is: Before he ever took Prozac in 5 the last two or three months of his life, did Bill 6 Forsyth exhibit a worried, panicky nature? 7 A. I will answer you that he exhibited on 8 occasions episodes of anxiety. 9 Q. With respect, I would like for you to answer my 10 question. If you can't answer it, you may say so. 11 A. I have a serious problem, because this word has 12 two almost completely opposite meanings in the lay use 13 of the word and the psychiatric use of the word. Now, 14 if you want to ask me the specifically psychiatric use 15 of the word, that's fine, but until I'm clear which 16 use of the word you're asking me the question in, I 17 have to insist on remaining neutral. 18 Q. We'll leave that blank. 19 A. Okay. 20 Q. Do you agree that William Forsyth showed signs 21 of paranoia -- 22 A. No. 23 Q. Hold on. I hadn't finished yet. -- before he 24 ever took Prozac? 25 A. No, I don't. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 954 1 Q. Do you agree that Bill Forsyth felt that he had 2 lost control of his life before he took Prozac? 3 A. No. Again, can we try and get some clarity on 4 the question? Statements that I feel at the moment 5 that I've lost control of my life, are not the same as 6 considered judgments that I've lost control of my 7 life. Clearly at the moment, I would feel that I have 8 lost control in my life in that it's in your hands 9 right at the moment, but that's a very different thing 10 to the overall judgment -- 11 Q. The objective observer might have a different 12 view, Doctor. 13 A. Well, well. That's very different to saying 14 that this man had come to the point where he had made 15 a considered judgment that he had lost control of his 16 life. We all feel we've lost control of our lives 17 from time to time. 18 Q. Before he took Prozac did Bill Forsyth say that 19 he felt like he had lost control of his life? 20 A. As the rest of us I'm sure have also at some 21 point, I think he did as well, yes. 22 Q. So we'll put yes to that. 23 A. Yes in the sense that he said that he had the 24 feeling of lost control. We're not saying in 25 considered judgment that he had lost control. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 955 1 Q. You saw I put the word say in there? Bill say 2 he felt he lost control of his life. 3 A. We need to make clear to people, though, that I 4 don't believe that he had come to a considered 5 judgment that he had lost control of his life. 6 Q. Now, I want to ask you whether another 7 particular circumstance was a significant source of 8 stress for Bill Forsyth. After he retired, he was 9 spending much more time at home with his wife. This 10 was very different than he had experienced during the 11 time he was an active working person. 12 My question is, do you agree that his spending 13 much more time at home with his wife was a significant 14 source of stress for Bill Forsyth before he ever took 15 Prozac? 16 A. Right. Mr. See, we're going to have to get 17 padantic here again, at least, I am unfortunately. We 18 cannot, by definition, say that he was abnormally 19 stressed because this is the condition that all of us 20 go through when we're retired. This is normal. Now, 21 you've used the word significant in this context. I 22 have no idea what it means. 23 Q. Meaningful. 24 A. He went through a change in life. It opened up 25 some opportunities for him. Clearly things were PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 956 1 changing. I'm not sure it would be fair -- I don't 2 know that you can call it -- you clearly cannot call 3 it an abnormal stress. Would that satisfy you? 4 Q. I want to accurately record your answer. Is it 5 don't know, or no or you tell me? 6 A. He was at a turning point in his life. He was 7 undergoing a normal stress. 8 Q. A normal stress, okay. Would you agree that 9 before he ever took Prozac, Bill Forsyth felt like he 10 was trapped in his marriage and that was a source of 11 stress for him? 12 A. Mr. See, I doubt if there is a single person in 13 this room, who is married, who hasn't at some point 14 felt trapped in their marriage, so from that point of 15 view he was entirely normal. 16 Q. So your answer would be, yes, but in a normal 17 way? 18 A. My answer would be he was not in an abnormal 19 state. 20 Q. So no abnormal stress as a result of feeling 21 trapped in his marriage? 22 A. I actually happen to believe that what 23 Mr. Forsyth and his wife were doing was rather 24 creative in ways. They were looking at their lives 25 again. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 957 1 Q. I just want to get past this point so we can go 2 to the next one. Would it be accurate then that your 3 view is that Bill Forsyth, having feelings of feeling 4 trapped in his marriage, was not an abnormal stressor 5 to him? 6 A. I do not believe this was an abnormal stressor. 7 By definition it cannot be an abnormal stressor. 8 Q. Okay. Now, maybe cutting to the bottom of the 9 line on this kind of question. It is your view, is it 10 not, that during the last two or three months of Bill 11 Forsyth's life, way before he took Prozac, that Bill 12 Forsyth had no significant sources of stress in his 13 life? 14 A. I think Bill Forsyth was not under abnormal 15 stress or pathological stress. 16 Q. So no abnormal or pathological stress? 17 A. That's right. 18 Q. Now, I specifically want to ask you this: In 19 your view did Bill Forsyth have suicidal thinking, I 20 think that sometimes the doctors call it suicidal 21 ideation, before he ever took Prozac? 22 A. In my view, Mr. See, every single human being 23 has suicidal ideation, and I think if any of us here 24 were to die by suicide, at least, someone that we know 25 would be able to say of us that, yes, they voiced a PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 958 1 suicidal thought at some point or other. The record 2 in regards to Mr. Forsyth's suicidal ideation strongly 3 indicates that if he had the occasional suicidal 4 thought, he didn't have much, and furthermore, as I've 5 indicated to you, suicidal ideation in its own right 6 is not a risk factor for suicide. 7 THE COURT: Not a what? 8 THE WITNESS: Not a significant risk factor in 9 its own right unless something else has happened. 10 Q (By Mr. See) Believe me I heard all of that 11 part, but with respect, I want to ask you if you can 12 answer my question. Did Bill Forsyth have suicidal 13 thinking or suicidal ideation as a result of his major 14 depression before he ever took Prozac? 15 A. Right. The -- as the phrase sits on the board 16 there, if I answer yes, it's going to read as though I 17 think this man was significantly suicidal. I'm saying 18 to, I think I've said quite clearly, that I don't 19 think he was. 20 Q. I just want the truth, Doctor. I want what you 21 think. 22 A. Yeah, well, that's what I'm offering you, what 23 I think. 24 Q. So is your answer, not that it mattered? 25 A. Voicing an idea about suicide is not the same PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 959 1 thing as suicidal thinking. Suicidal thinking implies 2 that you're constantly ruminating about the idea. If 3 you're asking me was this man constantly ruminating 4 about suicide, I think the record, as I've read it, is 5 very clear that he wasn't. 6 Q. Did Bill Forsyth have suicidal thinking before 7 he took Prozac? 8 A. My problem, Mr. See, again, is I think you're 9 asking me to give an answer that is going to read as 10 though I think this man was ruminating about suicide, 11 and I don't believe he was. 12 Q. Okay. We'll leave that one blank. Do you 13 agree with this: Before Bill Forsyth ever took 14 Prozac, his condition of major depression was out of 15 control? 16 A. No, I don't agree with that statement. 17 Q. Do you agree that Bill Forsyth's inability to 18 adjust to his retirement was an important fact in the 19 development of his depression? 20 A. I don't think it was, Mr. See. And this is -- 21 we have to be clear here. Before you interact too 22 much, can we just try to clarify some terms here? 23 Q. I'm just writing down the question. 24 A. All right. Fine. 25 Q. Because I want to make sure I get your answer PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 960 1 just right. 2 A. Good. I'm pleased that you want to make sure 3 of that. 4 When everybody changes, when they move job, 5 when they move where they're living from, we all have 6 a mild mood disorder of some sort. We can feel some 7 lethargy, loss of interest. It takes a while to get, 8 sort of, readjusted, but this is reasonably normal. 9 This is a relatively normal reaction. 10 Now, you're introducing the word major 11 depression into all of this. Now, the problem I have 12 with that is this: It's a very specific psychiatric 13 term. Clearly we're not in lay language here, and 14 DSM-IV allows us to talk about major depression to 15 apply this term to what may be very mild conditions. 16 If you have the criteria, under DSM-IV, probably 17 everybody in this courtroom may have had a major 18 depression disorder at some point or another. 19 Now, if you want me to say did his inability to 20 adjust to retirement, did it lead to a mild depressive 21 disorder, I'll say yes, it may well have contributed. 22 If you want to imply by the word major, which is a 23 tricky word here, that he had a severe depressive 24 disorder, then I couldn't agree to that. 25 Q. Maybe we could get past this question. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 961 1 A. Maybe we can. 2 Q. Would you agree that Bill Forsyth's inability 3 to adjust to retirement did lead to a mild depression 4 in your opinion? 5 A. It may have contributed. I'm not saying it's 6 the causal factor. We're back to cause and effect 7 here. I don't know how much it contributed. It may 8 have contributed some. 9 Q. Is it your opinion that it contributed? 10 A. It may have contributed some, but this may be 11 anything from one to two to three to five to ten 12 percent of the contribution. I don't know. 13 Q. I'm going to write down "May have contributed 14 some to a mild depression," how about that? 15 A. Yeah, okay. 16 Q. Now, I want to ask what's a bigger question, do 17 you agree, Dr. Healy, that Bill Forsyth developed the 18 psychiatric condition major depression before he ever 19 took Prozac? 20 A. I agree that Mr. Forsyth had a condition that 21 can meet criteria for major depression, but he had a 22 milder form of it, mild to moderate form at the most, 23 and he had a condition that could have been handled 24 without antidepressant drugs at all. He did not have 25 the kind of condition that necessitated antidepressant PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 962 1 drugs or other physical treatments. Just to be 2 absolutely clear. 3 Q. So your answer to my question did Bill Forsyth 4 have diagnosable psychiatric condition, major 5 depression, before he ever took Prozac? And your 6 answer is yes, but a mild form? 7 A. He had a mild to moderate depressive disorder. 8 Q. Now, you wrote a report in this case which was 9 provided to me, which set out your opinions and your 10 reasoning. You recall writing that? 11 A. This is the very first report; is that right? 12 Q. Yes, sir. 13 A. Yeah. Yes, I recall writing it. 14 Q. Now, in your report you set out some possible 15 explanations for the deaths of Bill and June Forsyth? 16 A. That I have considered, yes. 17 Q. That you had considered. Correct? 18 A. Yes. 19 Q. If you want to turn to your report, there's a 20 copy of it there under tab one of your book. I've 21 written down possible causes I've considered. 22 A. Yes. 23 Q. And I want to ask you about those if there were 24 some. First, you set out there is a possible 25 explanation for the deaths of Mr. and Mrs. Forsyth and PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 963 1 the events we're here about today, a possible 2 explanation for that is the existence of their marital 3 disharmony, correct? 4 A. No. 5 Q. Okay. Look at the first page of your report, 6 please. 7 A. I am looking at it. 8 Q. And then in the second paragraph it starts out, 9 "In my opinion," you see that? 10 A. Yes. 11 Q. I want to move down four lines to the sentence 12 that starts, "There are," and there you write, "There 13 are few available explanations to account for these 14 events based on current data. One possibility is the 15 presence of marital disharmony." Have I read that 16 correctly? 17 A. You have. 18 Q. And that's what you wrote in the report? 19 A. But I would like to have the context on this, 20 Mr. See. I think it would be awfully important to 21 read the rest of the paragraph. 22 Q. I understand you considered and dismissed 23 marital harmony -- 24 A. Disharmony, yes. 25 Q. Disharmony. You've dismissed it as a cause? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 964 1 A. Yes. 2 Q. All I'm asking about is what you considered? 3 A. Yes. Right. 4 Q. And one of the possible explanations for these 5 events that you considered is their marital 6 disharmony, right? 7 A. That's right. 8 Q. But as I understand it, under your view of the 9 facts, Bill and June Forsyth did not have significant 10 marital disharmony, correct? 11 A. Would you like me to read what I've written? 12 Q. I'd like you to answer my question that I just 13 asked. 14 A. What I said was that they had a degree of 15 conflict within their relationship that was entirely 16 within the range of normal. It was of the ordinary 17 domestic kind. This is what I've written. 18 Q. Okay. So as to marital disharmony, if we're 19 talking about your view of Bill and June Forsyth, you 20 would write down of the normal kind or within the 21 range of normal? 22 A. This seemed to me to be a relatively normal 23 marriage. In fact, I would go further, actually, 24 and -- I suppose you wouldn't want me to read further 25 just on that point, would you? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 965 1 Q. I've got another question for you. 2 A. All right. Go ahead. 3 Q. And as I understand your views, it is because 4 you believe that Bill and June Forsyth had a 5 relatively normal marriage, it's because of that that 6 you are able to dismiss their marital harmony -- their 7 marital disharmony as a cause of these events and 8 their deaths, correct? 9 A. What I'm saying is I've seriously, as I have a 10 duty to do, I have to seriously consider this option, 11 and it does not seem to me to be the likely option. 12 Q. And the rationale by which you are able to 13 conclude that this possible explanation, marital 14 disharmony, isn't the right one, is your conclusion or 15 your observation that the Forsyths had a marriage 16 within the range of normal, a relatively normal 17 marriage? 18 A. Mr. See, what I say is there's a great deal of 19 evidence. I was offered an awful lot of material to 20 read in a very short period of time. And I said 21 there's a great deal of evidence equally pointing to 22 the stability of this relationship and the basic 23 affection of the partners for each other and civility 24 toward each other. 25 Now, I'm being asked to explain a PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 966 1 homicide/suicide that involves an extraordinary level 2 of violence. This is just not any average suicide or 3 any average homicide. I'm saying that I can't see the 4 evidence in the marriage to account for this level of 5 violence. 6 Q. You have used the phrase in your report, the 7 ordinary domestic kind. That applies to their 8 marriage? 9 A. Yes. Against the background of basic civility 10 and affection. 11 Q. Now, the second possibility that you've 12 considered in your report was Bill Forsyth's condition 13 of depression mixed with anxiety, correct? 14 A. Yes. 15 Q. You would agree, as a psychiatrist, that major 16 depression, particularly major depression with 17 anxiety, it can lead, as a course of the disease, to 18 suicide? 19 A. As I've clearly indicated, sir, Mr. See, I 20 believe severe major depression is a significant risk 21 factor for suicide. I've also indicated to the Court, 22 that at the milder end of the range, which I referred 23 to Mr. Forsyth's condition here as, that, in fact, it 24 may -- it may even confer a protective effect against 25 suicide. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 967 1 Q. Do I understand you to say now that having 2 depression of a mild to moderate type is protective 3 against suicide? 4 A. I am saying to you that the only empirical data 5 in the field suggests that mild depressions, even if 6 left untreated, commit suicide at a rate that's lower 7 than people who aren't depressed at all. That's the 8 only data. 9 Based on that, if we're going to follow the 10 data, you and I have to believe -- you and I both have 11 to believe that mild depression may well confer a 12 protective effect against suicide. 13 Q. If I could just ask for you to respond to my 14 question. The next question is this: The last line 15 on the first page of your report, the last line? 16 A. On the first page, yes. 17 Q. Yes, sir. You write, "Depression, and 18 particularly depressive disorders accompanied by 19 anxiety, can lead to suicidal behavior." That's what 20 you wrote? 21 A. That's what I wrote, yes. 22 Q. Now, I also want to ask you this: You would 23 agree that -- I'm just talking about the disease, 24 major depression. The disease itself. That major 25 depression, in some patients, can lead or can be PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 968 1 associated with the commission of violent acts? 2 A. Mr. See, I would agree with you, but we have 3 this recurring ambiguity. You use the word major 4 depression. The word major here is unfortunate in 5 that it implies severe. You can have severe and 6 moderate and mild major depressions. 7 Now, if you're asking me does severe major 8 depression, is it associated with violent acts? I 9 would agree with you, but I don't believe that 10 Mr. Forsyth had this condition. 11 THE COURT: Let's take a 15-minute break, 12 please. Be back at quarter to three. 13 (Whereupon, a recess was taken from 2:30 p.m. 14 to 2:53 p.m.) 15 THE COURT: Please proceed, Mr. See. 16 MR. SEE: Thank you, Your Honor. 17 Q. Dr. Healy, we have been talking about severe 18 major depression being associated with violent acts. 19 A. And we agreed that Mr. Forsyth didn't have it. 20 Q. I beg your pardon? 21 A. At least I had said that Mr. Forsyth didn't 22 have severe major depression. 23 Q. Yes, sir. I wonder if you would turn to your 24 deposition that I just handed you at Page 15. 25 A. What page? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 969 1 Q. Fifteen. I want to start on line three. 2 A. Yes. 3 THE COURT: I'm sorry, that was page what? 4 MR. SEE: 15, 1-5. 5 Q. And were you asked this question and did you 6 give this answer: 7 QUESTION: -- 8 MR. VICKERY: Excuse me, Your Honor. I'm 9 sorry. I must object. To put it in context, he has 10 to start on Line 22 of the page before, four lines 11 earlier, five lines earlier. 12 THE WITNESS: You'd have to start at the top of 13 the page of Page 14 and perhaps even Page 13 to put it 14 in context. 15 MR. SEE: Your Honor, with respect, Mr. Vickery 16 will have a chance to redirect. I'd just like to ask 17 Dr. Healy if he got asked the question and gave the 18 answer that goes to the point that I'm trying to 19 establish with him. 20 THE COURT: Go ahead and read off the part that 21 you want to read, but then read off the part that 22 Mr. Vickery would like you to read. 23 Q (By Mr. See) Now the question, this is at 15 24 Line 3, "Is it the case that the condition, major 25 depression, is associated in some patients with the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 970 1 commission of violent acts? 2 "ANSWER: Yes." 3 Did you get that question and give that answer? 4 A. I did, yes. 5 MR. SEE: And what did you want me to read? 6 MR. VICKERY: Start on Page 14 Line 22, and go 7 up to the place where you picked up. 8 Q (By Mr. See) Yes. 9 "QUESTION: Dr. Healy, is it the case that the 10 condition, major depression, is, in fact, associated 11 in many patients with violent acts? 12 "ANSWER: Not many patients, no. It will be 13 unusual." 14 Did you get that question and give that answer? 15 A. I did get that question and give that answer, 16 but the context is larger again. You're asking me 17 about another individual on whom you're asking me to 18 comment. 19 Q. No, sir, I'm not. 20 A. Yes, you are. 21 Q. With respect. My next question is this: 22 Violent acts can be associated, as you said, with 23 severe major depression up to and including homicide, 24 correct? 25 A. I said that violent acts can be associated with PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 971 1 severe major depression. 2 Q. Yes. 3 A. In the context of a man who had killed his 4 wife, whom I had been asked to see, who had had severe 5 chronic pain in his hips. He had had both hips 6 removed. We're talking about a very specific case. 7 Q. Dr. Healy, my question is a general question. 8 If you would like to disagree with it or answer it in 9 the negative, that is your prerogative, sir. 10 A. I want to avoid the implication that I applied 11 this statement to the Forsyth case at all. This was 12 about an entirely different case. 13 THE COURT: Are you asking a question from the 14 deposition now? 15 MR. SEE: I am. 16 THE COURT: What page? 17 MR. SEE: Well, I'm asking him the question at 18 Page 15 Line 3, which is a general question not 19 connected with any specific individual. 20 THE WITNESS: No. Well, as I read the problem, 21 Your Honor, if you go back to Page 14, you probably 22 even have to go back to Page 13, I was being asked 23 about a man who had killed his wife. 24 MR. SEE: Your Honor. I'm sorry, Dr. Healy, if 25 you would just give me just a moment. Your Honor, may PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 972 1 I ask that the Court instruct the witness to be 2 responsive to the questions? 3 THE COURT: If there is any problem with the 4 question, your attorney or Mr. Vickery will -- 5 THE WITNESS: Yes, Your Honor. 6 THE COURT: -- raise any objections. 7 Otherwise, just answer the question. Next question. 8 MR. SEE: All right. Thank you, Your Honor. 9 Q. Now, did I hear you correctly, Dr. Healy, 10 during your direct examination, did you say that 11 suicide was a rare event? 12 A. Yes. And, Mr. Vickery, can I explain how 13 rare -- 14 MR. VICKERY: I object to that. 15 THE WITNESS: Sorry, Mr. Vickery. 16 MR. VICKERY: I object vehemently to that. 17 Q (By Mr. See) I'm going to ask you about that 18 right now. Isn't it true, Dr. Healy, notwithstanding 19 your saying that suicide is a rare event, it is, in 20 fact, as of the time Bill Forsyth and June Forsyth 21 died, the ninth most common cause of death in the 22 United States? 23 A. I don't know whether it was the ninth most 24 common cause of death in the United States. I can 25 tell you from the United Kingdom where the Jick study PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 973 1 was done -- 2 Q. Dr. Healy, that's not my question, with 3 respect, sir. You'll have a chance when Mr. Vickery 4 comes back again. If you'll just let me ask you my 5 questions -- 6 A. And your question is? 7 Q. I'll get the next question for you, thanks. I 8 would like to ask you about some of the effects of the 9 disease, major depression. You agree that major 10 depression can negatively affect a patient's ability 11 to perceive and understand people around them? 12 A. It negatively colors how they are viewing 13 things particularly if the condition becomes moderate 14 to severe. It's only if it's extraordinary severe 15 that it compromises their ability to judge and 16 perceive these things. 17 Q. And you agree that major depression can cause 18 people to misinterpret their own feelings as a part of 19 the disease? 20 A. If it's severe, yes. If it is mild to 21 moderate, no. 22 Q. Well, would you turn to Page 119 of your 23 deposition, please, at Line 15. Were you asked this 24 question and did you give this answer: 25 "Would you agree that Mr. Forsyth's mixed PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 974 1 anxiety depressive state did have a negative impact on 2 the marriage relation with his wife? 3 "ANSWER: It was clearly a stress in the 4 relationship. In my clinical practice, I regularly 5 see one -- I would see either a husband or a wife who 6 both come to me and one of them is actually depressed. 7 I make it my practice to not make any judgments about 8 the state of the marriage until both are well because 9 depression is the kind of disorder which people can 10 misinterpret. They can misinterpret their feelings in 11 terms of conflicts in the marriage. So it tends to 12 bring conflicts that may not really be there. It 13 tends to create conflicts that may not really be 14 there." 15 Did you give that answer? 16 A. I gave that answer. 17 Q. So you would agree that a person who is 18 depressed, that person will see the real conflicts in 19 their life as being more serious than they actually 20 are? 21 A. No, this is not what I said here in the 22 deposition, Mr. See. What I've said repeatedly 23 throughout is the word can. This can happen and it 24 will be particularly likely to happen in severe 25 depression. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 975 1 Q. I'll change my question to can. If I said can, 2 then you would agree with that? It can happen? 3 A. And it would be likely to happen in severe 4 depression. 5 Q. Now, your deposition was taken in this case on 6 July 11, 1997, that would be right on the cover of 7 that, but that's about the right date? 8 A. That's about the right date, yes. 9 Q. And at that time you had formed the conclusion 10 that you've told the jury about that, in fact, it was 11 Prozac that caused the deaths of William and June 12 Forsyth, right? 13 A. Yes. 14 Q. Now, you, as a physician and a psychiatrist, 15 you actually prescribe and have prescribed Prozac 16 yourself, don't you? 17 A. I have and do. 18 Q. And you started prescribing Prozac to your own 19 patients about the time it came on the market in the 20 United Kingdom? 21 A. I did, indeed. 22 Q. And at the time of your deposition in 1997, you 23 still prescribed Prozac? 24 A. I did, indeed. 25 Q. And this was after you published your case PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 976 1 report, the challenge case report you talked about, 2 right? 3 A. Yes. 4 Q. After you published this article, "Fluoxetine 5 and Suicide Controversy"? 6 A. Absolutely. 7 Q. Now, when you, as a physician, prescribe 8 medication for your own patients, you do a 9 risk/benefit analysis, don't you? 10 A. Yes, I do, indeed. 11 Q. You consider the possible benefits of the 12 medication and you weigh them against the possible 13 risks for that patient, correct? 14 A. I do, indeed. 15 Q. And so the jury is clear, you recognize that 16 physicians all over the world have prescribed Prozac 17 for millions of people since the time it first came on 18 the market? 19 A. It's all over the world is incorrect as I've 20 explained earlier. Large sections of the world do not 21 prescribe Prozac, and it is mandatory in most parts of 22 Europe for people who are put on Prozac to be reviewed 23 within a week of being put on Prozac and the 24 risk/benefit analysis to be reassessed. 25 Q. Millions of people have taken Prozac; haven't PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 977 1 they, Doctor? 2 A. They have, indeed. 3 Q. And you would agree that it is accepted that in 4 most cases, Prozac reduces suicidal thinking? 5 A. Oh, I am happy, Mr. See, that in very many 6 cases, that prescribing Prozac to patients who are 7 mildly to moderately depressed -- because it won't 8 help suicidal ideation in severe depression -- but who 9 are mildly to moderately depressed and suicidal before 10 they go on it, will reduce the level of suicidality 11 for a substantial proportion of people, but this very 12 finding compromises and obscures the fact that there 13 are people who get worse on it. 14 Q. Would you turn to the Jick article, which is 15 tab 25 of your book, please. Are you there? 16 A. Yes, I am. 17 Q. I'd like to ask you to look at the first page 18 the left-hand column in the abstract and come down to 19 the conclusions part. Do you see that? 20 A. Yes. 21 Q. I want to bring to your attention what it says 22 there. 23 THE COURT: Excuse me, what exhibit is the 24 Jick? 25 MR. SEE: It's been marked as Exhibit 155, Your PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 978 1 Honor. 2 THE COURT: 155? 3 MR. SEE: Yes, sir. 4 THE COURT: Thank you. Please proceed. And 5 what page are you on? 6 MR. SEE: Actually, Your Honor, I'm going to go 7 over to the last page of the article. 8 Q. Dr. Healy, it is 218 down at the bottom, but 9 the copies are kind of cut off, so it's the last page. 10 A. Right. 11 Q. There's a box there on the left called key 12 messages. Do you see that? 13 A. I do, indeed. 14 Q. I want to bring to your attention the third key 15 message there, and it says -- well, these key messages 16 are -- these are the conclusions of the authors? 17 A. Yes. 18 Q. The third one says, "People with a history of 19 suicidal behavior were at a greatly increased risk of 20 committing suicide." You see that? 21 A. I do. 22 Q. And in the final key message there by the 23 authors of the Jick paper it says, "The risk of 24 suicide was not determined by the antidepressant 25 prescribed." You see that? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 979 1 A. I do. 2 Q. Did I read it correctly? 3 A. You did. 4 Q. Now, if you'd go to the right-hand column under 5 conclusions, do you see that part? 6 A. I do. 7 Q. I want to go about halfway down that paragraph 8 and there is a sentence which starts out, "Though the 9 suggestion," do you see it? 10 A. Yes. 11 Q. And I want to draw that sentence to your 12 attention, and it reads, "Though the suggestion has 13 been made that fluoxetine" -- and that's Prozac, 14 right? 15 A. Right. 16 Q. -- "that Prozac may trigger an emotional state 17 which itself increases the risk of suicide, this 18 suggestion has not been supported by formal evidence." 19 Have I read it correctly? 20 A. You have. 21 Q. Now, I want to ask you one more question and I 22 have really stepped over one. When I was asking about 23 the key message, the last one there in the box, it 24 says, "The risk of suicide;" that is, from the data in 25 the Jick paper, "the risk of suicide was not PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 980 1 determined by the antidepressant prescribed." You 2 agree with that, don't you? 3 A. No, I don't based on the data that I can now 4 bring to bear on this issue. I don't agree with it. 5 Q. Dr. Healy, would you turn to tab 31 in your 6 book. 7 A. Yes. 8 Q. That's a paper by a Dr. Stuart Montgomery. Do 9 you see that? 10 A. Yes, I do. 11 Q. You're familiar -- you know Dr. Montgomery? 12 A. I do, indeed. 13 Q. Dr. Montgomery is a professor at the Imperial 14 Medical School in London? 15 A. He is. 16 Q. And that's an institution of some considerable 17 renown in the United Kingdom? 18 A. It's not one of the premiere institutions. 19 Q. Now, has Professor Montgomery held any office 20 in the British association for psychopharmacology? 21 A. He has been the president. 22 Q. He has been the president? 23 A. He has. 24 Q. And -- 25 A. At the same time as I was the secretary. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 981 1 Q. How about that? 2 A. How about that. 3 Q. Now, you have testified, have you not, that to 4 be a member, not even to say an officer, of the 5 British Association for Psychopharmacology means that 6 the person would have an unusual degree of expertise 7 in that field; that is, psychopharmacology, correct? 8 A. As I would have, he also has, yes. 9 Q. Now, if you'd look down at the bottom on the 10 left-hand side of the first page of Dr. Montgomery's 11 paper -- I should say Professor Montgomery, shouldn't 12 I? 13 A. Yes. 14 Q. It indicates there that Professor Montgomery 15 was writing this paper as part of serving as chairman 16 for a symposium this was sponsored in Nice, France, 17 and it was sponsored by The Pharmacy, an Upjohn 18 Company; isn't that right? 19 A. That is correct. 20 Q. So that symposium and this paper coming from 21 that symposium, didn't come from Eli Lilly and 22 Company, did it? 23 A. Dr. Montgomery has had extensive consultancies 24 with Eli Lilly in the past. 25 Q. Yes, but if you would just zoom in on my PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 982 1 question. In the paper that we're talking about, 2 Dr. Montgomery is writing about an antidepressant 3 called Reboxetine, right? 4 A. He is. 5 Q. And that is an antidepressant that is marketed 6 by The Pharmacy, an Upjohn Company, isn't it? 7 A. It is. 8 Q. And, in fact, it is marketed in competition 9 with Eli Lilly and Company's Prozac, right? 10 A. In Europe. 11 Q. You would agree, wouldn't you, that The 12 Pharmacy, an Upjohn Company, is a competitor of Eli 13 Lilly an company with respect to these 14 antidepressants? 15 A. Yes, I would. 16 Q. Now, would you turn to Page 28 of that article, 17 which is really about the third page? 18 A. Yes. 19 Q. And under the heading "Tolerability," you see 20 that? 21 A. Yes. 22 Q. Let me go back again. You have respect for the 23 views and expertise of Dr. Stuart Montgomery, the 24 president of the British Association of 25 Psychopharmacology at the time when you were the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 983 1 secretary? 2 A. I have a certain amount of personal affection 3 for him and respect for him on a personal basis. We 4 disagree profoundly on many scientific issues. 5 Q. We're about to find one, I think. 6 A. Okay. 7 Q. Turn down to the fourth paragraph under 8 tolerability. The sentence that starts out, "The risk 9 of suicide," do you see that? 10 A. Yes. 11 Q. I want to draw that paragraph to your 12 attention. The first sentence says by Dr. -- 13 Professor Montgomery, president of the British 14 Association of Psychopharmacology, it says, "The risk 15 of suicide and the safety of antidepressants in 16 overdose are of major importance in the management of 17 patients with depression." Now, just that sentence. 18 You agree with that, don't you? 19 A. Would you -- actually, please, excuse me for a 20 moment. I was actually slightly distracted by the 21 person walking out of the court. 22 Q. You want me to read it again? 23 A. Yes, please do. 24 Q. "The risk of suicide and the safety of 25 antidepressants in overdose are of major importance in PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 984 1 the management of patients with depression." You 2 agree with that? 3 A. As it stands, no, you would have to insert the 4 word severe. 5 Q. Let's start the next sentence. "There have 6 been concerns that antidepressants can provoke or 7 worsen suicidal ideation or tendencies." I take it 8 you agree with that? 9 A. Yes. 10 Q. In fact, that's the question that you are here 11 to talk about, right? 12 A. Yes. 13 Q. Now, let's look at the next sentence by 14 Professor Montgomery. "It is important to remember, 15 however, that antidepressants will relieve suicidal 16 ideation and tendencies in the majority of patients, 17 and there is no clear-cut evidence from clinical 18 trials or from meta-analyses that any antidepressant 19 significantly increases suicide risk." 20 Now, my question for you is simply this: Did 21 you take Dr. -- Professor Montgomery's view into 22 account when you formed your opinion? 23 A. I have a particular problem with this, Mr. See, 24 which I need to explain to you and unfortunately, I 25 can't give you a yes or no answer here. I took PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 985 1 Professor Montgomery's work into account in particular 2 because I had correspondence from Dr. David Baldwin 3 who worked with Dr. Montgomery giving fluoxetine, 4 Prozac, to people who were depressed, and after my 5 case reports came out, Dr. Baldwin wrote me and said 6 that they, as a group, had witnessed exactly the same 7 phenomenon that I had been describing. 8 Q. Would you turn your attention down to the 9 bottom of the page we're talking about of Professor 10 Montgomery's article and I just want to draw to your 11 attention and agree with you on the date. It was 12 published in 1998, last year, wasn't it? 13 A. It was. 14 Q. Let me ask you about the last sentence of that 15 paragraph. It starts out, "SSRIs." Do you see that? 16 A. This one begins, "like the SSRIs," or am I 17 missing something? 18 Q. I'm at the sentence directly above that. It 19 starts out, "SSRIs." 20 A. Have a greatly reduced adverse event profile, 21 is that -- 22 Q. No, sir. 23 A. Sorry, I've lost you. 24 Q. Go to the fourth paragraph under tolerability 25 and I'm asking you about the last sentence of that PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 986 1 paragraph. 2 A. Right. Yes. 3 Q. Now, first, the term SSRI, you talked about it 4 before. It has a very long name, selective serotonin 5 reuptake inhibitor. It's the class of drug to which 6 Prozac belongs, right? 7 A. It is. 8 Q. So when someone says SSRIs, they would also be 9 talking about Prozac, right? 10 A. They would. 11 Q. Now, let's go back to the sentence. "SSRIs had 12 been found to reduce suicidal thoughts faster than 13 reference antidepressants and to protect against the 14 emergence of suicidal thoughts." Did I read that 15 correctly? 16 A. You did, Mr. See. 17 Q. And do you agree with Professor Montgomery, the 18 president of the British Association of 19 Psychopharmacology at the time you were secretary? 20 A. He isn't currently the president. We have to 21 be clear about this, but I agree that SSRIs, and I've 22 actually said this before, may reduce suicidal 23 thoughts in people who are depressed and suicidal to 24 begin with. I think the evidence that they do it 25 faster than reference antidepressants, is drawn if PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 987 1 you'll notice from the reference list from one study 2 that Dr. Montgomery did on Paroxetine, for which he 3 also has a consultancy with SmithKline and Beecham. 4 Now, the sentence does not preclude the 5 emergence of suicidal ideation. In some people the 6 drug may well protect against the emergence of 7 suicidal ideation. A statement like that does not 8 preclude the fact that in others, it may provoke 9 suicidal ideation. 10 Q. Okay. So maybe you agree with part of that and 11 maybe you disagree with part of that, is that where 12 you come down? 13 A. That's what it looks like. 14 Q. Would you turn to tab six. Are you there? 15 A. I am, yes. 16 Q. Tab six is the program for the meeting of the 17 American Psychiatric Association in Toronto this last 18 year, in 1998; is that right? 19 A. It is. 20 Q. And you presented at that program, right? 21 A. I did. 22 Q. Okay. Would you turn to Page 126 of that 23 exhibit -- of that tab. 24 A. I'm there already. 25 Q. In fact, the abstract of your presentation is PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 988 1 right there? 2 A. It is. 3 Q. And you presented on a drug called Reboxetine? 4 A. I did. 5 Q. An antidepressant? 6 A. An antidepressant. 7 Q. What I want to ask you about, these meetings 8 like the meeting in Toronto of the American 9 Psychiatric Association, this is one of the meetings 10 that you described in your direct examination where 11 psychiatrists and researchers and so on from near and 12 far come and convene; is that right? 13 A. Yes. 14 Q. And the purpose of such a meeting is to 15 exchange the latest research results, among other 16 things? 17 A. Yes. 18 Q. Talk about new studies, good things, bad 19 things, problems, papers presented, people want to 20 talk about their research, what they found out. It's 21 a quick way to exchange information, right? 22 A. Yes, broadly speaking. It does more than just 23 that, but broadly speaking. 24 Q. That's one of the purposes of having such a 25 meeting? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 989 1 A. Um-hum. 2 Q. And it truly draws the real top experts in the 3 field, doesn't it? 4 A. No. 5 Q. It does not? 6 A. No. 7 Q. But it draws lots of them, doesn't it? 8 A. It draws a number of experts. The majority of 9 people there are probably general psychiatrists. 10 Q. Now, what I want to draw your attention to is 11 this: On the same page as your abstract about 12 Reboxetine -- 13 A. Yes. 14 Q. -- if you look just on the other side of the 15 page down at the bottom, there is reported a study of 16 a drug called, is it Venlafaxine? 17 A. Venlafaxine. 18 Q. Venlafaxine. And that study was done by the 19 Wyeth drug company? 20 A. It was, yes. 21 Q. And Venlafaxine is an antidepressant drug? 22 A. It is. 23 Q. So the Wyeth drug company was presenting data 24 about this particular study about their antidepressant 25 at the meeting, right? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 990 1 A. They were. 2 Q. And they tested their antidepressant against 3 another antidepressant, didn't they? 4 A. They did. 5 Q. And that was Prozac, wasn't it? 6 A. They tested their drug against Prozac for a 7 very specific reason. 8 Q. And it was against -- it had to do with 9 depressed patients also, didn't it, that study? 10 A. It had to do with depressed patients. 11 Q. Now, there's nothing about Prozac causing 12 suicide or homicide in that abstract, is there? 13 MR. VICKERY: Objection, there's no foundation 14 laid under 80318 for this particular entry, Your 15 Honor. It's not a peer-reviewed journal. There is no 16 foundation that -- 17 THE WITNESS: These are not peer reviewed. 18 MR. VICKERY: It is just an abstract in a 19 paper. 20 MR. SEE: I am asking Dr. Healy about what kind 21 of information was presented at this meeting. There 22 were several. I don't want to testify, Your Honor, 23 but -- 24 THE COURT: I'll sustain the objection. 25 Q (By Mr. See) Was data presented at this PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 991 1 meeting from several different pharmaceutical 2 companies, each competitors against Lilly, each 3 presenting data about their antidepressant tested 4 against Prozac? 5 A. Yes. There was a considerable amount of data 6 with their antidepressant tested against Prozac and 7 all companies were doing it for a particular reason. 8 Q. Did you say you attended another meeting, the 9 European -- 10 A. College of Neuropsychopharmacology? 11 Q. Yes, in Paris? 12 A. Yes. 13 Q. And that was last year? 14 A. That was last October. 15 Q. And did you attend quite a few sessions at that 16 meeting? 17 A. I attended some of the sessions, yes. 18 Q. And do you know that there were 10 or 15 19 different studies presented at that meeting by 20 different investigators testing antidepressant drugs 21 against Prozac and some testing Prozac against placebo 22 and so on, but you're aware that that kind of data was 23 presented at that meeting? 24 A. Mr. See, I will be happy to take your word that 25 there were roughly 10 to 15 presentations, but again, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 992 1 I will draw your attention to the fact that these were 2 all done for a very specific point. 3 Q. Now, we heard you talk about case reports, and 4 I want to ask you about four specific questions about 5 them. 6 A. You didn't hear me talk about case reports. 7 Q. Pardon me. I want to ask you four specific 8 questions about case reports. 9 A. You didn't hear me talk about case reports. 10 Q. I've got a new question now. 11 A. But you asked me -- 12 Q. I beg your pardon. I now want to ask you 13 questions about case reports if you will. 14 A. Yep. 15 Q. A case report is a report, an article, a letter 16 to the editor by a physician who has given a drug to a 17 patient in his or her practice and noticed something 18 happened and -- or one patient or several patients and 19 then will write that up as perhaps being of interest 20 to their colleagues and many of those get published in 21 the medical journals, correct? 22 A. No. Would you like me to help you with this 23 one, Mr. See? 24 Q. There are a number of different kinds of case 25 reports, right? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 993 1 A. There are controlled clinical studies where the 2 convention is for senior investigators to present a 3 number of cases and the convention is when you begin 4 to describe the details of the case to write at the 5 top, case reports. 6 This is a very -- these are not, however, case 7 reports in the sense that you're implying. Case 8 reports in the sense that you're implying are the 9 conditions where one physician sitting on his own in a 10 room with a patient will report that I saw this. Now, 11 I am -- 12 Q. Dr. Healy, again with respect, with respect, if 13 I could just ask if you're willing to answer 14 questions? If you are, I'll ask one. 15 A. I've been answering your question. 16 Q. I want to ask you about -- specifically about 17 case reports, and here's the question. With respect 18 to a case report, if you give a patient a drug -- a 19 doctor gives a patient a drug, a patient in your own 20 practice, you for example, and you notice or observe 21 some kind of adverse event, isn't it correct that one 22 of the possibilities is that adverse event was 23 actually caused by the drug, right? 24 A. Absolutely, yes. 25 Q. Again, we're talking about administering a drug PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 994 1 to a patient in, for example, your practice? 2 A. Yes. 3 Q. Another possibility is the patient may have 4 been taking more than one medication and the event was 5 caused by some other drug the patient was taking? 6 A. Absolutely, yes. 7 Q. And another possibility is that the event was 8 caused by the underlying disease for which the drug 9 was prescribed, correct? 10 A. This is a possibility. 11 Q. And again, in this case report situation that 12 we're discussing another possibility is, because 13 you're giving it to one patient at a time, that the 14 occurrence of the event was a coincidence? It 15 happened by coincidence at the time the drug was 16 given, that's a possibility? 17 A. That's a possibility. 18 Q. Would you turn to tab 22? 19 A. I will be happy to. 20 Q. That is your review article, the one we looked 21 at the blow up of? 22 A. Yes, it is. 23 MR. VICKERY: Is this the 94 article, Mr. See? 24 MR. SEE: Yes. 25 MR. VICKERY: It's Exhibit 153. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 995 1 MR. SEE: It's Exhibit 153, Your Honor. 2 THE COURT: Thank you. 3 Q (By Mr. See) First, I'd like to turn your 4 attention to the second page of that article, which is 5 marked Page 224. 6 A. Yes. 7 Q. And I want to go down to the second paragraph 8 on the first or left-hand column, the one that starts 9 out that there was immediate criticism? 10 A. Yes. 11 Q. Now, here you are writing about the Teicher 12 article, correct? 13 A. I am, yes. 14 Q. And that's the article you told us about 15 earlier. I can't seem to find it, but it was the 16 article by Dr. Teicher and it came out, was it 1990? 17 A. It was, yes. 18 Q. And you write about that, and let me draw this 19 to your attention about the Teicher article. There 20 was immediate criticism of the article, and you mean 21 the Teicher article, right? 22 A. I do. 23 Q. The article by Teicher. The main criticisms 24 are listed in table one and then you've listed them? 25 A. I have. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 996 1 Q. Then you write, "Subsequently, a meta-analysis 2 of clinical trials involving 3,065 patients and 3 retrospective analysis of 1,017 patients who had 4 received fluoxetine was performed," right? 5 A. Yes. 6 Q. And you write, "These analyses suggested that 7 fluoxetine" -- and that's Prozac, right? 8 A. Can we be clear when we read this that I'm not 9 saying that they suggested to me. This was the 10 analysis that I wrote -- 11 Q. I'm asking you what this says. 12 A. -- to the BMJ. Well, words often have 13 equivocal meanings, and it did not suggest to me -- 14 Q. Well, the only question now is what's written 15 on the paper, Doctor, that's all. The last sentence 16 says, "These analyses suggested that fluoxetine was 17 unlikely to lead to the emergence of suicidal 18 ideation." That's what's written there, correct? 19 A. That's what the authors of the analysis 20 suggested the data revealed. It's not what I'm 21 suggesting the data revealed. 22 Q. Now, would you turn over to Page 227 of that 23 article. And I want to ask you about your table 24 two -- 25 A. Yes. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 997 1 Q. -- which is up at the top of the right-hand 2 column. Do you see it? 3 A. Yes. 4 Q. Now, in your table two you say -- it is 5 entitled criteria required for a case report of a 6 drug-induced adverse effect to be considered reliable, 7 right? 8 A. Yes. 9 Q. So you've written in that table the 10 requirements that you would put on a case report of a 11 possible drug-induced adverse effect in order to 12 consider it reliable, right? 13 A. The ideal requirements. 14 Q. Well, you didn't write ideal in there, did you, 15 Doctor? 16 A. I didn't expect that this was going to be 17 subject to litigation, this particular report, and 18 that every word would be analyzed so carefully. 19 Q. We're just after what you wrote. 20 A. Yes. What you're after, I guess, is what I 21 understood rather than what I wrote. 22 Q. Let me ask you what you wrote, because, I mean 23 that's what we know about. The second one down there, 24 is it correct you wrote, "The adverse effect should 25 not be a manifestation of the underlying illness," PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 998 1 correct? 2 A. That is correct. 3 Q. And that means if a case report is to be 4 considered reliable, to figure out whether the drug 5 caused the event, then the event can't be one that is 6 naturally occurring with the disease, right? 7 A. No, that's not what it means, Mr. See. Would 8 you like me to explain it to you? 9 Q. The next item -- 10 A. You don't want it to be explained? 11 Q. I want to ask you about the next item. 12 A. Fine. 13 Q. The next item says, "The individual should not 14 be taking other medications." You wrote that? 15 A. I wrote that. 16 Q. Now, if you would turn to tab 28, please. Are 17 you there? 18 A. I am. 19 Q. This is an article by the first author, Fiona 20 McKay do you see that? 21 A. McKay. 22 Q. McKay, I beg your pardon. Do you know 23 Ms. McKay? 24 A. No, I don't, but that's the way it would be 25 actually pronounced. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 999 1 Q. And, in fact, this article is from your 2 country, right, The United Kingdom? 3 A. Yes, it is. 4 Q. Now, down under the authors it is listed that 5 it is from or they work for the Drug Safety Research 6 Unit in the United Kingdom. Do you see that? 7 A. I do. 8 Q. Do you know what that is? 9 A. I do, indeed. 10 Q. Would you tell us? 11 A. I would be very happy to. Now, in my review, I 12 clearly stated, as you indicated to the jury, that it 13 would be misleading to believe that fluoxetine -- 14 MR. SEE: Your Honor, may I ask that the 15 witness respond to my question. It was what is -- 16 THE COURT: Would you repeat the question and 17 just answer the question that he asks you. 18 Q (By Mr. See) Dr. Healy, you were going to 19 tell us what the Drug Safety Research Unit is in your 20 country, The United Kingdom? 21 A. The Drug Safety Research Unit collects 22 anecdotal reports largely. 23 Q. Now, go down under the summary of this article, 24 under objective, and it says, "To compare the safety 25 and side effect profiles of the four selective PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1000 1 serotonin reuptake inhibitor antidepressant, 2 fluvoxemine, fluoxetine" -- that's Prozac, right? 3 A. It is. 4 Q. Sertraline and Paroxetine, so they are 5 comparing four antidepressants? 6 A. They are. 7 Q. Dr. Healy, did you take this Fiona McKay 8 article into account when you formed your opinions in 9 this case? 10 A. No. In my review, which you pointed out, I 11 clearly stated that taking this kind of data into 12 account, even if it had suggested that Prozac was 13 causing treatment emergent suicidality would be a 14 mistake. 15 Q. Have you read the Fiona McKay article before 16 today? 17 A. I have, yes. 18 Q. And is it your testimony that it contains 19 anecdotal data? 20 A. Yes, it's largely anecdotal data, essentially. 21 Q. It, in fact, was done through the prescription 22 event monitoring program; isn't that right? 23 A. That's right, yes. 24 Q. And under the methodology on the next page, you 25 know that the Drug Safety Research Unit gets PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1001 1 prescriptions because of the socialized medicine 2 circumstance in your country, right? 3 A. That's correct. 4 Q. And so they can gather all these prescriptions 5 together and, in fact, they did, with respect to these 6 four antidepressants, correct? 7 A. Yes. 8 Q. And they then solicited, by means of 9 correspondence directed to physicians who had 10 prescribed those antidepressants, solicited 11 information with respect to the outcome of those 12 prescriptions, correct? 13 A. Correct. 14 Q. And then got the information back from the 15 doctors and tabulated it, right? 16 A. That's correct. 17 Q. And turn over to Page 237, please. And under 18 table one it shows the size -- 19 MR. VICKERY: Objection to him going to the 20 substance of this. There is no proper foundation 21 under 80318 that is peer reviewed, reliable 22 information. If Mr. See doesn't lay that foundation, 23 it can't be used as a learned treatise. 24 Q (By Mr. See) Dr. Healy, do you know what the 25 Pharmaco, Epidemiology and Drug Safety Journal is? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1002 1 A. I know that it's a journal that will have heavy 2 sponsorship from the pharmaceutical industry. I don't 3 know if its articles are peer reviewed. 4 Q. Okay. 5 MR. SEE: Well, Your Honor, I want to ask him 6 about the outcome of the article, and if Mr. Vickery 7 has an objection, then I would like to ask him those 8 questions. 9 MR. VICKERY: I do have an objection. There's 10 no foundation under 80318 that this is reliable 11 information. It's anecdotal reports. There's no 12 proof that it's peer-reviewed, and I've just learned 13 that this institute that publishes it is heavily 14 sponsored by the pharmaceutical industry. There is no 15 basis of liability whatsoever. 16 MR. SEE: If I may, Your Honor. Dr. Healy has 17 already testified that the authors work for the 18 government, the Drug Safety Research Unit of the 19 United Kingdom. 20 THE COURT: I'll allow the question. 21 Q (By Mr. See) Dr. Healy, if you're at 22 Page 237 -- 23 A. Now, hold on, Mr. See, one moment. Yes, I'm on 24 Page 237. 25 Q. There's a table one there, correct? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1003 1 A. There is. 2 Q. And all I want to do is ask you to confirm the 3 number of pieces of data that were gathered on each of 4 these drugs. Under fluvoxemine, the size of the group 5 that was studied was 10,983 people, correct? 6 A. I can confirm that half of the green forms that 7 were sent out were returned, yes, and that came to 8 10,983. 9 Q. Yes. And there were 12,692 data on that many 10 patients collected on Prozac, correct? 11 A. I can confirm with you as well that half of the 12 forms that were sent out on Prozac were returned, and 13 that figure came to 1,002 -- 1,692. 14 Q. Thank you. And the figure for the 15 antidepressant Sertraline was 12,734? 16 A. Again, a 50 percent response to the number of 17 forms that were sent out. 18 Q. The number is correct? 19 A. The number is correct. 20 Q. And for Paroxetine, 13,741, correct? 21 A. That's the correct figure, but again, the same 22 considerations apply. 23 Q. Now, if you would turn over to Page 243. There 24 is a heading, deaths and suicides. Do you see that? 25 A. I haven't quite got there. Give me a moment. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1004 1 Yes. 2 Q. I want to draw to your attention the last two 3 sentences in that paragraph and they read, "The 4 difference between the number of suicides with each of 5 the four SSRIs was not statistically significant. No 6 death in these studies was attributed to an SSRI." 7 Have I read that correctly? 8 A. You have, indeed, Mr. See. 9 Q. Would you turn over to Page 245, please. In 10 the left-hand column under selective events, I want to 11 read the last paragraph in that column. Do you see 12 that? It starts out, "There was no." 13 A. Yes. 14 Q. "There was no statistical significance between 15 the number of suicides and the SSRI taken. It has 16 been suggested that fluoxetine might promote suicidal 17 ideation. Our data do not support this view." Have I 18 read that correctly? 19 A. You have read that correctly. 20 Q. Let me ask you to -- you said you have read 21 this paper before, Dr. Healy? 22 A. Yes. It is one on which I wouldn't put much 23 thought. In fact, they don't provide the data to 24 support the conclusion that you just read out. They 25 make the statement, but there is no data supporting PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1005 1 that. 2 Q. Would you turn to tab 26? 3 A. I will happily do so. 4 Q. That's a study by Dr. Andrew C. Leon? 5 A. It is. 6 Q. Entitled, "Prospective Study of Fluoxetine 7 Treatment and Suicidal Behavior in Effectively Ill 8 Subjects," correct? 9 A. That is correct. 10 Q. And under methodology in the abstract -- well, 11 have you read this paper? 12 A. I have, indeed, yes. 13 Q. And so you know that the data came from the 14 National Institute of Mental Health, collaborative 15 depression study, right? 16 A. That's correct. 17 Q. And you know that that is a study in which they 18 enrolled a number of people who presented themselves 19 for treatment for depression and then followed those 20 people over the years to see what happened? 21 A. Absolutely, correct. 22 Q. And the study really didn't do anything to the 23 people, it just followed them and observed them, 24 correct? 25 A. Yes. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1006 1 Q. Real life situations, correct? 2 A. Real life situations. 3 Q. And if you read the paper, you know, don't you, 4 that one of the findings -- 5 MR. VICKERY: Objection. Before he states his 6 finding, Your Honor, there is no foundation for this 7 document under 80318. It says that this document is 8 supported, in part, by Eli Lilly and Company for whom 9 three of the authors work. There's no foundation that 10 this is scientifically reliable at all. It is just 11 something written by three Lilly consultants that are 12 not here. 13 Q (By Mr. See) Dr. Healy, let me ask you about 14 the American Journal of Psychiatry. Are you familiar 15 with that journal? 16 A. I am. 17 Q. It's a peer-review journal? 18 A. It's a peer-review journal. 19 Q. Would you say that it is the most prestigious 20 psychiatric journal published in the United State? 21 A. No, it's clearly not, an it's known not to be. 22 Q. All right. Let me ask you to turn over to 23 Page 200. 24 A. Yep. 25 Q. The question I was going to ask you when PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1007 1 Mr. Vickery objected was this: Because you've read 2 this paper you understand that one of the findings was 3 in this group of people that was followed, that a 4 number of them had been prescribed Prozac for their 5 depression, correct? 6 A. Yes. 7 Q. And one of the findings of the study was -- 8 MR. VICKERY: Excuse me, Mr. See. Before you 9 say that out loud, I object until the foundation is 10 laid that this is a reliable study, Your Honor. 11 There's no foundation that this is a learned treatise 12 under 80318. This is a Lilly document published last 13 month on this issue by three people who are not here 14 for me to cross-examine. 15 MR. SEE: Your Honor, Dr. Healy has just 16 testified that the American Journal of Psychiatry is a 17 peer-review medical journal in which this article 18 appears. It is not a Lilly document. 19 THE COURT: Well, it appears to be 20 peer-reviewed. 21 MR. SEE: Absolutely. 22 THE COURT: I'll allow the question. 23 Q (By Mr. See) And there were a number of other 24 of these depressed people followed over the years who 25 were prescribed other antidepressants, right? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1008 1 A. This is the case. 2 Q. And one of the findings about the people that 3 got Prozac in this observational study was that they 4 were sicker, they had more severe illness before they 5 got the drug as compared with the patients who got the 6 other antidepressants; isn't that right? 7 A. No, that's not strictly speaking correctly. I 8 know that phrase appears in the text, but if you would 9 look -- we would be here all day really. The issue is 10 how do you define severity. 11 Q. If you don't agree with what I said, then 12 that's your answer. Let me ask you this question. 13 A. Okay. 14 Q. Turn to Page 200 please under discussion, and I 15 would like to ask you about, starting the second 16 sentence there, which says "The results," do you see 17 that? 18 A. Yes. 19 Q. And it says, "The results indicate that 20 although fluoxetine was prescribed to more severely 21 ill subjects, their risk of suicidal behavior was not 22 elevated. Instead, there were non-significant 23 protective effects of fluoxetine and other somatic 24 antidepressant treatments in the absence of 25 fluoxetine." PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1009 1 Have I read that correctly? 2 A. You have. 3 Q. Now, I want to ask you about -- a sentence 4 about the middle of the right-hand paragraph and it 5 starts out, "Despite the greatest severity," do you 6 see that? 7 A. Yes. 8 Q. And it reads, "Despite the greater severity and 9 suicidality before the use of fluoxetine, suicidal 10 behavior did not increase with the use of fluoxetine." 11 Have I read that correctly? 12 A. You have. 13 Q. Could I ask you to turn to tab 36, please? 14 A. You certainly could. 15 Q. And that's an article by Meredith G. Warshaw? 16 A. Yes. 17 Q. Have you read that one? 18 A. No, I haven't actually. 19 Q. I'll draw your attention down to the bottom, it 20 says, "Supported in part by the Upjohn Company and by 21 Eli Lilly. Do you see that? 22 A. I do, yes. 23 Q. Dr. Healy, let me ask you, have you in the 24 course of your work an professional life, have you 25 received grants from pharmaceutical companies -- PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1010 1 A. I have. 2 Q. -- in order to perform research? 3 A. Yes, I have. 4 Q. Now, did your receipt of grants an supports 5 from pharmaceutical companies, it didn't make you into 6 a liar did it? 7 A. No, it didn't, but I think there's a general 8 belief in the field that people can be compromised by 9 this. 10 Q. I'm just asking about you. 11 A. Fine. 12 Q. And the fact that you received a grant from a 13 pharmaceutical company in order to carry out research, 14 it didn't make you publish falsified data, did it? 15 A. No. 16 Q. The Journal of Clinical Psychiatry is a 17 peer-review journal in the United States? 18 A. The Journal of Clinical Psychiatry is 19 peer-reviewed, but it actually publishes a lot of 20 non-peer-reviewed material as well. 21 Q. Okay. Now, let me turn you over to Page 165 of 22 the Warshaw article, please, under the discussion 23 section. 24 A. Yes, I'm there. 25 Q. I want to draw your attention to the first PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1011 1 couple of sentences there. It says, "In the harp, 2 that's H-A-R-P, Study." Do you know what HARP refers 3 to? 4 A. No, I don't offhand. You'll have to help me 5 with that, Mr. See. 6 Q. It's the Harvard-Brown Anxiety Disorders 7 Research Program? 8 A. Thank you. 9 Q. H-A-R-P. 10 A. Right. 11 Q. So we'll go on with the sentence, "In the HARP 12 study, we found no evidence that subjects who used 13 fluoxetine during follow-up were at higher risk of 14 suicide attempts or gestures than those who did not. 15 Indeed, among those subjects having episodes of major 16 depressive disorder at intake, there was a 17 statistically significant lower probability of suicide 18 attempts or gestures for those taking fluoxetine." 19 Did I read that correctly? 20 A. You did. 21 Q. Now, if you could turn your attention to the 22 bottom of that column, where it says, "In summary," 23 you see that? 24 A. Yes. 25 Q. It says, "In summary, we found no evidence that PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1012 1 fluoxetine was associated with an increased risk of 2 suicidal behavior in the study of patients with 3 DSM-IIIR anxiety disorders. To the contrary there was 4 a significantly lower probability of suicide attempts 5 in patients with both an anxiety disorder and a 6 depressive disorder who had received fluoxetine 7 compared with those who did not receive fluoxetine 8 during this study." Have I read that correctly? 9 A. You have. 10 Q. You are familiar with an organization called 11 the American College of Neuropsychopharmacology? 12 A. I am, indeed. 13 Q. And that is an organization of people with 14 interests and expertise in training like you; isn't 15 that right? 16 A. It is. 17 Q. And that's a member -- an invitation only 18 organization, correct? 19 A. That's correct. 20 Q. And membership in that organization implies 21 some considerable expertise in the area of 22 psychopharmacology; isn't that right? 23 A. It's an organization for which Jonathan Cole 24 and Theodore Van Putten have been previous presidents. 25 Q. So that's up here, a high-level organization? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1013 1 A. I'm just saying to you that people who have 2 reported on this phenomenon have been among the 3 leading people from this particular college reporting 4 the phenomenon that we're here discussing today. 5 Q. All right. Have you turned to tab five? 6 A. No, I haven't. Had you asked me to? 7 Q. Would you please if I hadn't. Are you familiar 8 with that document? 9 A. No, I'm not familiar with this particular 10 document, Mr. See. 11 Q. All right. 12 A. I would have to say to you that I believe it to 13 be severely out of date, if you look at the date of 14 it. 15 Q. Yes, I understand. I'm just going to ask you 16 some questions about it, if I can. 17 A. Fine. 18 Q. Now, the title, "Suicidal Behavior and 19 Psychotropic Medication accepted as a consensus 20 statement by the NCAP counsel, March 2, 1992;" is that 21 correct so far what it says? 22 A. That is correct so far. The important thing 23 that you read, of course, is the date. 24 Q. We read the date, didn't we? 25 A. Yes, we did. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1014 1 Q. Okay. First, I'd like to ask you to turn to 2 Page 7. 3 A. All right. 4 Q. And I want to refer you to the second paragraph 5 on that page which starts out, "In conclusion," do you 6 see that? 7 A. Yes. 8 Q. And this is what I want to draw to your 9 attention from the NCAP consensus statement. "In 10 conclusion, case reports suggestion that a small 11 minority of patients may experience emergent suicidal 12 thoughts or events such behavior during the 13 pharmacological treatment of depression. These 14 reports do not distinguish between the relative 15 potential contribution of the disease process, 16 external stressors, or the medication. Of 17 significance, there is evidence that such emergent 18 suicidality is not specific to any one type of 19 antidepressant and may, therefore, be largely a 20 manifestation of the natural course of the disease." 21 Have I read that correctly? 22 A. You have read that correctly. 23 Q. May I ask you to turn over to Page 9? And I'd 24 like to ask you about under the number six, "Clinical 25 Issues and Conclusions"? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1015 1 A. Yes. 2 Q. I'd like to ask you about the paragraph marked 3 C, do you see that? 4 A. I do. 5 Q. And does that say, "There is no evidence that 6 antidepressants, such as the selective serotonin 7 reuptake inhibitors, for example, fluoxetine" -- and 8 again, fluoxetine is Prozac, isn't it? 9 A. It is. 10 Q. Okay. So they say "There is no evidence that 11 antidepressants such as Prozac trigger emergent 12 suicidal ideation over and above rates that may be 13 associated with depression and other antidepressants. 14 What is clear is that most patients receive 15 substantial benefit from treatment with this drug and 16 related antidepressants." Have I read that correctly? 17 A. You have read that correctly, but clearly 18 events have marched on and I doubt that the NCAP would 19 write that now. 20 Q. Now, turn to Page 30 please for the last item. 21 A. Okay. 22 MR. VICKERY: I'm sorry, did you say Page 30 or 23 Tab 30? 24 MR. SEE: I meant tab 30. I beg your pardon. 25 Q. Tab 30 is an article entitled, "The Adverse PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1016 1 Effects of Antidepressants," and it comes from the 2 pharmacy department at Maudsley Hospital in London. 3 Do you have that? 4 A. Yes, I do. Yes. 5 Q. And the date of publication is 1997. Do you 6 see that? 7 A. I do. 8 Q. Would you turn over to Page 93? 9 A. Could I quickly point out to you that it's from 10 a group of pharmacists who have never seen a patient 11 in their life. 12 Q. As I said it is from the pharmacy department at 13 Maudsley Hospital in London, isn't it? 14 A. The pharmacy department? 15 Q. Yes, sir. 16 A. Yes. 17 Q. Would you turn over to Page 93? I want to ask 18 you about the conclusion. You see the conclusion? 19 A. Yes. 20 MR. VICKERY: Objection, Your Honor. There is 21 no foundation under 80318. There is just none. There 22 is no indication that this is a reliable authority 23 that's relied on by one of his experts or recognized 24 by Dr. Healy. 25 Q (By Mr. See) Are you familiar with Maudsley PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1017 1 Hospital in London? 2 A. I am familiar with the journal which is not 3 peer reviewed. 4 Q. And Current Opinions in Psychiatry, that's a 5 journal that's read by psychiatrists in the United 6 Kingdom? 7 A. This is a journal that is not peer reviewed and 8 psychiatrists in the United Kingdom get copies 9 distributed to them by Eli Lilly and Company in 10 particular. 11 Q. Let me ask you about the conclusion, Dr. Healy. 12 MR. VICKERY: I object to him doing that until 13 he has a proper foundation that this is a reliable 14 learned treatise under Rule 80318. 15 THE COURT: Sustained. 16 Q (By Mr. See) Turn to tab 20, please. You're 17 familiar with the Harvard Medical School, aren't you? 18 A. I'm sorry, I've got the wrong tab. 19 Q. Yes. It's 20? 20 A. Yes, I'm told by Mr. Vickery that it's not as 21 good as Yale, but, yes, I have heard of it. 22 Q. And tab 20 is a copy of an issue of the Harvard 23 Mental Health Letter, you see that? 24 A. It's the Harvard Mental Health Letter. I have 25 no idea if this is peer reviewed. The title of the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1018 1 journal suggests it's not. 2 Q. But you're familiar with the Harvard Medical 3 School, are you not? 4 A. I am familiar with the Harvard Medical School, 5 yes. 6 Q. And the top of this article says from the 7 Harvard Medical School, doesn't it? 8 A. It may not be peer reviewed in any way, 9 Mr. See. I am unable to help you with that one. 10 Q. And do you regard the Harvard Medical School as 11 an acknowledged, responsible medical institution in 12 the United States? 13 A. I have to tell you, Mr. See, before just 30 14 seconds ago, I had never heard of the Harvard Mental 15 Health Letter. 16 Q. That's not what I asked you. I asked you about 17 the Harvard Medical School. 18 A. I accept Harvard is well-known, but the Harvard 19 Mental Health Letter is unknown almost. 20 Q. Unknown to you? 21 A. To me certainly, and I'm sure to most people -- 22 to an awful lot of people outside of Harvard I 23 suspect. 24 Q. Let me ask you to turn over to Page 2. 25 A. I doubt anyone from Yale would accept the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1019 1 conclusions in this, but yes. 2 Q. Do you have Page 2? 3 A. I have Page 2. 4 Q. I want to ask you to turn to the last two 5 sentences on the left-hand column in the first 6 paragraph. It starts out, "On the other hand," do you 7 see that? 8 A. Yes. 9 Q. Now, this issue of the Harvard Mental Health 10 Letter was published, as indicated on the front page, 11 in January of 1995, you see that? 12 A. Yes. 13 Q. And it reads -- 14 MR. VICKERY: Objection, there's no foundation 15 under 80318. 16 MR. SEE: My experts will establish the 17 foundation if the Court believes it is not present. 18 It is the Harvard Mental Health Letter from the 19 Harvard Medical School. 20 THE COURT: I'll sustain the objection at this 21 time. 22 THE WITNESS: Mr. See, could you help me with 23 who the author is? I don't even know who the author 24 is. This may have been authored by an individual from 25 Eli Lilly for all I know. Can you see the author PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1020 1 here? 2 MR. SEE: Your Honor, my experts will make a 3 foundation for this. They will tie it up at that 4 time. 5 THE COURT: Pardon me? 6 THE WITNESS: They will tie it up at that time. 7 If Dr. Healy won't acknowledge the Harvard Medical 8 School, I guess I can't lay the foundation through 9 him. 10 THE COURT: All right. I'll allow it, but I'll 11 strike it if your experts do not establish that as a 12 peer-reviewed article. 13 MR. SEE: Yes, sir. 14 Q. Dr. Healy, would you look at the conclusion -- 15 THE COURT: Or we could recall Dr. Healy at 16 that time, if you wish, Mr. Vickery. 17 MR. VICKERY: I appreciate that, Your Honor. 18 I'm afraid the logistics involved from Wales back 19 here, probably won't work. 20 THE COURT: Okay. So we'll proceed at this 21 point. 22 Q (By Mr. See) The sentence starts, "On the 23 other hand," do you see that, Dr. Healy? 24 A. No. You'll have to take me back to where you 25 want me to go. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1021 1 Q. The second page. 2 A. Yes. 3 Q. The left-hand column. 4 A. Yes. 5 Q. The first paragraph. 6 A. Yes. 7 Q. The last two sentences. 8 A. Right. 9 Q. And it starts out, "On the other hand," do you 10 see it? 11 A. Yes. 12 Q. "On the other hand, critics have also claimed 13 that fluoxetine causes suicides. The evidence against 14 that claim is strong. Antidepressant drugs, in 15 general, as one would expect, reduced the danger of 16 suicide and SSRIs are no exception." Did I read that 17 correctly? 18 A. You read that correctly. 19 Q. And, Dr. Healy, the last thing I want to ask 20 you is, do you accept that statement from the Harvard 21 Medical School in the Harvard Mental Health Letter? 22 A. I do not accept the statement at all. 23 MR. SEE: Those are all the questions I have. 24 THE WITNESS: There's a lot of Eli Lilly 25 sponsored work that happens at Harvard. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1022 1 MR. SEE: Your Honor, I move to strike the last 2 statement of the witness as being non-responsive. 3 THE COURT: The last statement will be stricken 4 and the jury is instructed not to regard it. 5 MR. SEE: Thank you, Dr. Healy. 6 THE WITNESS: You're very welcome, Mr. See. 7 THE COURT: You have some redirect? 8 MR. VICKERY: Yes, I do, Your Honor, I'm 9 afraid. 10 THE COURT: Well, we're past four o'clock, so 11 let's adjourn at this time and please be back at nine 12 o'clock. I want to meet with counsel. 13 (Whereupon, the following proceedings were had 14 in open court out of the presence of the jury.) 15 THE COURT: I take it your next witness is 16 Dr. Shlensky? 17 MR. VICKERY: Actually, not, Your Honor. There 18 were others that were scheduled to come in tomorrow 19 morning and arranged their schedules for that. We've 20 got coming up tomorrow, Amy Lee, the marketing person 21 from Lilly, who I think will probably be a very short 22 witness. 23 THE COURT: Very short. 24 MR. VICKERY: Well, it doesn't sound like she 25 knows anything, but we'll find out. I don't have her PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1023 1 deposition. We have the two treating physicians, 2 Dr. Riggs Roberts and Dr. Randolph Neal. I don't 3 think either of them, frankly, from my perspective is 4 a real long witness, but I think it's important that 5 the jury hear from them. 6 THE COURT: Sounds like you've filled up the 7 morning already. 8 MR. VICKERY: Well, I know. We also have 9 Dr. Shlensky who I'd like to get out of here tomorrow 10 because he has a plane out tomorrow night. We have 11 Dr. Tom Brady who saw them in the marital therapy in 12 the fall, and then -- that certainly is going to be 13 all we can get to tomorrow. I've already told counsel 14 who the rest of ours are for the rest of the case. 15 We have a very short fact witness, Dorothy 16 Smith. We have Mr. Forsyth's wife at sometime, 17 probably Tuesday. She'll be a short fact witness, and 18 then, of course, Susan Forsyth, herself. So I think 19 that we have -- I think -- 20 THE COURT: Who was the last one? 21 MR. VICKERY: I'm sorry, Your Honor. 22 THE COURT: I thought you said Mr. Forsyth, 23 Jr.'s wife? 24 MR. VICKERY: Right. 25 THE COURT: And then who was the last person? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1024 1 MR. VICKERY: Susan Forsyth, his sister. I 2 think that's it. Did I miss anybody? I believe 3 that's it. 4 THE COURT: That sounds like several more days. 5 MR. VICKERY: I don't know. I don't know how 6 I'm doing on the clock, but I think I'm still okay on 7 the time we told the Court. I believe so. I hope to 8 be finished Tuesday. 9 THE COURT: Have you reviewed the -- I think 10 you said this morning you wanted to review 11 Dr. Shlensky's deposition? 12 MR. VICKERY: We have reviewed -- I have not 13 personally done that, Your Honor. Ms. Barth has been 14 working on that. She and I have not had an 15 opportunity to confer about that. We were going to if 16 he was going on today, but when it became obvious that 17 he wouldn't come on today, she and I haven't had a 18 chance to confer about it. She has been doing that 19 quite diligently, I can assure you. 20 THE COURT: Did he limit his opinion as Mr. See 21 represented this morning? 22 MR. VICKERY: I forget what Mr. See said this 23 morning. Oh, I know. No, he did not. I think his 24 opinion references or attaches almost every one of the 25 documents that Mr. See complains about, and so he PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1025 1 cites them that these are things that he looked at, 2 relied upon in arriving at his opinions. 3 THE COURT: Well, I thought that Mr. See said 4 this morning that during his deposition he stated 5 something to the effect that any causation opinion 6 would have to be based on statistically significant 7 epidemiological evidence? 8 MR. VICKERY: I haven't had a chance to talk to 9 Ms. Barth about that specific representation by 10 Mr. See, so I don't know. I haven't had a chance to 11 look at the deposition and see if that's what he said, 12 but I can tell the Court that I know that in his -- in 13 his report, I'm sorry, that the principal liability 14 exhibits in issue here are things that he reviewed, 15 that he chronicled and cited, and said that he relied 16 on in arriving at his opinions. 17 THE COURT: Do you see a problem coming up on 18 that, Mr. See? 19 MR. SEE: In my view, as I've stated to the 20 Court, with respect to the scope of his opinion 21 question, I believe Dr. Shlensky disclosed -- he wrote 22 a report and gave a deposition on causation and on the 23 adequacy of the warning whether the product insert -- 24 package insert was adequate. There's no question 25 about that, but with respect to whether Lilly should PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1026 1 have submitted something or other to the FDA or 2 whether Lilly should have submitted something or other 3 to the BGA, did something wrong, or that sort of 4 thing, there's no opinion about that at all. There's 5 nothing in his report. He didn't give any testimony 6 about it. He testified about causation, and he had 7 about 10 million articles. But he testified about 8 causation, and he testified about the warning. Those 9 two issues, and I believe he's absolutely entitled to 10 give opinions on those two issues, but not others. 11 THE COURT: I thought you had raised some 12 concern about his causation opinion this morning? 13 MR. SEE: Absolutely. I absolutely did. I'm 14 sorry if I mislead the Court. 15 THE COURT: Well, what is it then? 16 MR. SEE: My objection to his testifying is, I 17 have all the same objections I had with Dr. Healy. I 18 think the Court's considered those, and I'm not -- I 19 have them, but I understand the Court's probably going 20 to rule the way the Court ruled with Dr. Healy, but 21 there is one very important difference. I think it is 22 on Page 336 of his deposition, Dr. Shlensky says -- 23 let me make sure my reference is right. I believe it 24 is Page 336. 25 I asked him if he would agree that it was PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1027 1 generally accepted in the scientific and medical 2 community that in order to come to a cause and effect 3 conclusion that the drug had to be shown to be 4 associated with this bad effect to a statistically 5 significant degree, and he replies, I think that's a 6 fair statement. 7 So I would submit, with respect to Daubert, 8 Dr. Shlensky has set the standard. He has conceded, 9 admitted of what the standard is. To make a 10 scientifically valid causation opinion, you've got to 11 have some data that shows the drug is actually 12 associated with the event, to a statistically 13 significant degree. His own testimony. 14 I mean, I don't know what he's going to come up 15 with, but I don't think that data has been forthcoming 16 from him. If I missed it, I've missed it, but I don't 17 think he's shown that, so by his own standard. 18 THE COURT: Mr. Vickery. 19 MR. VICKERY: Your Honor, I just flat haven't 20 had the opportunity to confer with Ms. Barth about 21 everything else in that deposition. I think that 22 we're going to have to look at it very carefully. I 23 think it's obvious from Mr. See's comments, that if 24 there is a Daubert hearing, which I suspect is what's 25 concerning Your Honor, how we budget our day in terms PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1028 1 of time for that, if there is to be one, I think it's 2 obvious that it will be very short. I think either we 3 can show the Court, here's a reason, here's a 4 legitimate reason why he can give causation testimony, 5 or the Court will look at this sequence from his 6 deposition and the totality of that evidence and say, 7 no, you haven't got it. He can't testify on 8 causation. 9 So I think the hearing procedure, as such, 10 would be very short, five to ten minutes perhaps at 11 most, and I would suggest perhaps we might just give 12 the jury an hour and 15 minutes for lunch instead of 13 the usual hour and deal with it at that time if it 14 needs to be done. I just need to be able to confer 15 with Ms. Barth in private tonight about whether it 16 needs to be done at all. We may -- well, I just need 17 to confer with her. 18 THE COURT: All right. I'm not sure I share 19 your enthusiasm as far as a five-minute Daubert 20 hearing. I'll see you at nine o'clock. 21 (Whereupon, the proceedings were adjourned at 22 4:15 p.m. to be reconvened on Friday, March 12, 23 1999 at 9:00 a.m.) 24 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 1029 1 C E R T I F I C A T E 2 --ooOOoo-- 3 I, TINA M. STUHR, Official Court Reporter, 4 United States District Court, District of Hawaii, 5 Honolulu, Hawaii, do hereby certify that the foregoing 6 is a correct partial transcript of proceedings in 7 Civil No. 95-00185ACK, Susan K. Forsyth, et al. vs. 8 Eli Lilly and Company, et al., at Honolulu, Hawaii, on 9 March 11, 1999, before the Honorable Alan C. Kay, 10 United States District Judge. 11 DATED: December 20, 1999. 12 13 ______________________________________ TINA M. STUHR, RPR, CSR #360 14 15 16 17 18 19 20 21 22 23 24 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU