652 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 652 - 837 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 Wednesday, March 10, 1999 at 9:15 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 653 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 654 1 I N D E X 2 DAUBERT HEARING 3 DAVID HEALY, M.D., Ph.D. PAGE 4 Cross-Examination Continued by Mr. See 656 Redirect Examination by Mr. Vickery 667 5 Recross-Examination by Mr. See 668 6 WITNESSES ON BEHALF OF PLAINTIFFS: 7 BARBARA COMSTOCK 8 Direct Examination by Mr. Vickery 703 Cross Examination by Mr. See 712 9 Redirect Examination by Mr. Vickery 733 10 DAVID HEALY, M.D., Ph.D. 11 Direct Examination by Mr. Vickery 747 12 13 14 15 16 17 18 19 20 21 22 23 24 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 655 1 (Whereupon, the following proceedings were had 2 in open court out of the presence of the jury.) 3 THE CLERK: Civil No. 95-00185 ACK, 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 Forsyths. 7 THE COURT: Good morning. 8 MR. SEE: Good morning, Your Honor. Andy See, 9 Michelle Mangrum, and Ed Burke on behalf of Eli Lilly 10 and Company. 11 THE COURT: Good morning. 12 MR. SEE: Good morning, sir. 13 THE COURT: I think you said you had about 15 14 minutes more with Dr. Healy? 15 MR. SEE: I think that should do it, Your 16 Honor. 17 THE COURT: Dr. Healy, front and center. 18 You're reminded you're still under oath, 19 Dr. Healy. 20 THE WITNESS: Yes, Your Honor. 21 MR. SEE: Your Honor, if I might approach and 22 put in front of the witness the four documents I'm 23 going to be asking him about? 24 THE COURT: Very well. 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 656 1 CROSS-EXAMINATION (Continued) 2 BY MR. SEE: 3 Q. Dr. Healy, first I'd like to ask you about the 4 article you mentioned yesterday by William C. 5 Wirshing, which is W-I-R-S-H-I-N-G. Do you have that 6 in front of you? 7 A. Yes. 8 Q. Now, this is one of the articles you say you 9 relied upon with respect to your conclusion that 10 Prozac, through causing akathisia, causes suicide, 11 correct? 12 A. Yes, it is. 13 Q. All right. Now, I'd like to refer you to the 14 second paragraph of the Wirshing paper that's in the 15 left-hand column, and it starts out saying, "We have 16 now had experience with five such patients." Do you 17 see where I am? 18 A. Yes. 19 Q. Now, I'm going to go down and read about after 20 two phrases and it says, "All reported an urge to pace 21 that paralleled the intensity of the distress. All 22 experienced suicidal thoughts at the peak of their 23 restless agitation." Have I read that correctly? 24 A. You have, Mr. See. 25 Q. Now, I want to ask you about -- he lists his PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 657 1 cases and then there's case one, and I want to go over 2 to the second middle column about a third of the way 3 down where it is described some of the symptoms that 4 case one experienced, and among other things, it says, 5 "Restlessness marked with a desire to pace and an 6 inability to find somatic comfort." Do you see that? 7 A. I do. 8 Q. And I've read it correctly? 9 A. You have. 10 Q. Now, I want to ask you about case two further 11 down in the same column, say about a third of the way 12 into the case two portion. It says, "Two and a half 13 weeks later she developed motor restlessness with a 14 compulsive need to pace." Do you see that? 15 A. I do. 16 Q. All right. Now, let me ask you about case four 17 which is over on the right-hand column all the way 18 down at the bottom on case four and it says, "She was 19 pacing incessantly." Do you see that? 20 A. I do. 21 Q. Now, I want to ask you about case five which is 22 over on the second page. Just about halfway down in 23 the paragraph about case five, it says, "She became 24 agitated, frantic, insomnic" -- that means can't 25 sleep; is that right? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 658 1 A. Yes. 2 Q. -- "and restless and unable to keep still. She 3 would take frequent long showers, pace, have her 4 husband rub her back in bed for relief." Do you see 5 that? 6 A. I do. 7 Q. Have I read that correctly? 8 A. You have. 9 Q. Now, could you turn to the Theodore Van Putten 10 article, please? 11 A. Yes. 12 Q. And Van Putten is two words, spelled V-A-N, 13 next word, P-U-T-T-E-N, correct? 14 A. Yes. 15 MR. VICKERY: Could we have the title, please? 16 MR. SEE: The title of the Van Putten article 17 is "Behavioral Toxicity of Antipsychotic Drugs." 18 Q. Correct, sir? 19 A. Yes. 20 Q. That's the article you were referring to 21 yesterday? 22 THE COURT: Antipsychotic? 23 MR. SEE: Yes, sir. That's what it says. 24 THE WITNESS: No, this was not the article that 25 I was referring to yesterday. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 659 1 Q (By Mr. See) You were not? 2 A. No. 3 Q. You have a Van Putten article that has to do 4 with Prozac? 5 A. Well, there is a Van Putten communication. He 6 is one of the authors on the Wirshing paper. 7 Q. Oh, I see. So that was your reference to Van 8 Putten? 9 A. No. He has other articles on akathisia. He 10 has many articles on akathisia. The best known of 11 which is called, "The Many Faces of Akathisia." 12 Q. I was only asking if you have an article -- and 13 I may have misunderstood you yesterday. That if you 14 have an article, a separate article, other than the 15 Wirshing one we just talked about by Dr. Van Putten 16 that has to do with taking Prozac and developing 17 akathisia? 18 A. The Wirshing article, I think, is the best one 19 to go by for this purpose. 20 Q. Very good. Now, you also mentioned yesterday 21 that you have looked at a Lilly document that talks 22 about the risk of suicide being 5.6 times the risk of 23 suicide in the other active comparison drugs, correct? 24 A. Yes. 25 Q. I have put before you Exhibit 1116, and I'd PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 660 1 like to ask you to turn to Page 26 of that exhibit. 2 Are you there on Page 26? 3 A. I am, yes. 4 Q. Now, as a preliminary question, you gave some 5 testimony yesterday, and I'm going over to the easel 6 here where Mr. Vickery has written some numbers. You 7 gave some testimony yesterday about the number or the 8 rate of suicides per 100,000 population and this was 9 the rate that Dr. Jick found with Prozac, correct? 10 A. Yes. 11 Q. And the calculation that Dr. Jick used took 12 into account the duration or length of time the 13 patients took the drug, correct? 14 A. The calculation didn't, at that point, take 15 into account the length of time that the patient took 16 the drug. When he looks at the rates at which the 17 periods of time he finds that during the first few 18 weeks of treatment, the rate is higher than 187. 19 THE COURT: That's Table 7? 20 THE WITNESS: Pardon? Yes, it is. It would 21 rise to 274. 22 Q (By Mr. See) All right. Maybe I'm not being 23 articulate. The numbers -- you readily agree with 24 that, I'm sure, don't you? 25 A. No, Mr. See, I don't agree with that one. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 661 1 Q. The way Dr. Jick analyzed the numbers of 2 suicide was to take into account patient years at 3 risk, correct? 4 A. Yes. 5 Q. And you agree that's an appropriate way to 6 analyze those numbers? 7 A. I do. 8 Q. Now, back to Page 26 of Exhibit 1116. 9 A. Yes. 10 Q. And in the first paragraph under suicide 11 attempts I will read the last sentence and it says, 12 "The incidence rate under Fluoxetine, therefore, 13 purely mathematically, is 5.6 times higher than the 14 other active medications Imipramine, Amitriptyline, 15 and Doxepin." Have I read that correctly? 16 A. Mr. See, you'll have to help me again. Just 17 exactly where is it you're reading from? 18 Q. Yes. It's on Page 26. 19 A. Yes, I have it. 20 Q. Have I read that correctly? 21 A. Yes, you have. 22 Q. Do you recognize, Dr. Healy, that the inclusion 23 of the phrase, "purely mathematically," indicates that 24 the patient years at risk have not yet been taken into 25 account when the 5.6 number was calculated? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 662 1 A. I do. 2 Q. Now, if you would look at -- so -- now, if you 3 would look at 1114, please. 4 A. Can you give me just one moment? 5 Q. I will. 6 THE COURT: Looking at what now? 7 MR. SEE: Exhibit 1114. 8 THE COURT: What page? 9 MR. SEE: It's on Page, at the top, 451. Upper 10 right-hand corner it says 451. 11 THE WITNESS: You want me to turn to which 12 page? 13 Q (By Mr. See) The page at the upper right-hand 14 corner, 451. Are you there, Doctor? 15 A. I am, Mr. See. 16 Q. Now, the table that appears at the bottom of 17 that page shows the -- 18 THE COURT: This is the BGA response? 19 MR. SEE: This is, in fact, a response by Lilly 20 to the BGA. It was also submitted to the FDA to show 21 the FDA what had been submitted to the German agency. 22 Q. All right. Now, Dr. Healy, at the bottom of 23 that page, there is a list called "Total Duration of 24 Observation." Do you see that table? 25 A. I do. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 663 1 Q. And it shows the patient years of exposure to 2 the different drugs analyzed, correct? 3 A. It does. 4 Q. And, for example, for Amitriptyline it shows 5 5.7 total patient years, right? 6 A. Yes. 7 Q. And going down -- well, for Imipramine, 91.7 8 patient years, right? 9 A. Yes. 10 Q. And going down to the very bottom, it shows for 11 Fluoxetine, which is Prozac, correct? 12 A. Yes. 13 Q. It shows 485.7 years, correct? 14 A. Correct. 15 Q. Those patient years of exposure or patient 16 years at risk were not included in this 5.6 times 17 number that you cited to the Court; isn't that right? 18 A. That's correct. 19 THE COURT: So what's the significance of that? 20 MR. SEE: The significance -- 21 THE COURT: I'm asking him. 22 MR. SEE: Sorry. 23 THE WITNESS: Oh, well, Your Honor, Lilly's 24 internal documents show that their estimate was that 25 their drug was 5.6 times more likely to produce PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 664 1 suicide or suicide attempts than reference 2 antidepressants. If we turn back to Document 1116, 3 which I have been asked to look at by Mr. See, and if 4 we go to Page 26, and if we go to Paragraph 3, under 5 Fluoxetine, two out of 243 patients attempted suicide. 6 This would be an incidence of 8.2 per 1,000 patients, 7 and this would come out as 820 per 100,000 patient 8 years. 9 Among the 242 Imipramine and placebo patients, 10 the same number of patients exposed, the same number 11 of patient time, the incidence of suicide attempts was 12 zero. Same document we're reading from. 13 Q (By Mr. See) And let me now ask you the 14 question to follow up, have you done a calculation to 15 see whether in 243 patients on the one hand in 16 Fluoxetine, and 242 patients on the other hand in 17 Imipramine, whether that difference is statistically 18 significant or whether it could be under universally 19 recognized statistical testing, the result of chance? 20 Have you done that testing? That's the question. 21 A. I clearly, Mr. See, could not have done the 22 testing on the piece of paper that you've shown me now 23 because I've only just seen it for the first time, 24 this piece of paper here. But I can go further if you 25 wish me to on this issue. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 665 1 MR. SEE: Your Honor, those are the questions I 2 have for Dr. Healy on voir dire, but I'd like to 3 address the Court at the appropriate time. 4 THE COURT: You say you could go further, what 5 does that mean? 6 THE WITNESS: There are a few things that I 7 could go further on, Your Honor. I would like to come 8 back to the Wirshing article, which I was asked to 9 look at first. Mr. See, pointed to the fact that four 10 of the five patients paced. 11 Now, this is reported pacing by the patients. 12 In only one of the incidents that I've noticed, was it 13 observed by the clinicians that the patient was 14 pacing. This is self-report by the patient. By 15 clinicians sensitive to the phenomenon, worried that 16 this may be happening, going back and asking the 17 patient, are you more restless than usual? 18 So there is no -- in the ordinary course of 19 events in clinical practice, the pacing that Mr. See 20 has drawn your attention to, would have been missed. 21 It would still be akathisia even if the pacing were 22 missed. Same phenomenon. 23 MR. SEE: Your Honor, I move to strike 24 Dr. Healy's last statement as being pure speculation. 25 THE WITNESS: It's not pure speculation, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 666 1 Mr. See. 2 MR. SEE: It was addressed to the Court, 3 Doctor. Sorry. 4 THE WITNESS: Sorry. I'm very sorry. 5 THE COURT: Why do you say it's not pure 6 speculation? 7 THE WITNESS: I think this is well recognized 8 if you read the articles of Theodore Van Putten and 9 others. They say that unless the clinical people 10 involved have a high index of suspicion that this 11 phenomenon is happening, they will miss it, they -- 12 unless they actually ask the patient. 13 They will notice that the patient is in some 14 way out of sorts, but unless they actually ask the 15 patient what's going on, they won't get reports from 16 the patient, gosh, look. I can't sit still. I seem 17 to have to walk around the place. It has to be 18 extremely severe before it will be observed by the 19 clinical members of the staff that the patient has 20 visibly observable pacing that they can pick up 21 without asking the patient. 22 THE COURT: Thank you. Did you have any other 23 questions, Mr. Vickery? 24 MR. VICKERY: Just one, Your Honor, if I may. 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 667 1 REDIRECT EXAMINATION 2 BY MR. VICKERY: 3 Q. If I understood correctly, if I was following 4 you, I want to make sure I'm on the right page, the 5 Jick figures for suicide and suicide attempts on 6 Fluoxetine are 187 per 100,000 patient years? 7 A. Exactly. 8 Q. And if you take the internal Lilly document 9 that Mr. See just asked you to look at and you adjust 10 that for patient years, is it 820 per 100,000? 11 A. No. This is an even more serious problem, 12 Mr. Vickery. Let me explain what the problem is. The 13 Jick study looks at people who actually die. If we 14 use internal Lilly documents to look at the probable 15 number of suicide efforts that don't result in actual 16 death, then they say there will be between 80 and 30 17 times the number of suicide attempts for every single 18 death, so you would have to multiply the figure of 187 19 up, probably by a factor of something like 20, to get 20 the true figure for suicidal episodes on this drug. 21 Now, that's entirely consistent with the other 22 figures that I've been asked to look at in 23 Exhibit 1116. 24 Q. So you mean the true figure then would be over 25 3,000 attempts or suicides per 100,000 patient years? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 668 1 A. That's the true figure based on Lilly 2 estimates, yes. 3 MR. VICKERY: Okay. That's all I have for this 4 witness at this hearing, Your Honor. 5 MR. SEE: I have one more based upon 6 Mr. Vickery's last, if I may? 7 THE COURT: You may. 8 RECROSS-EXAMINATION 9 BY MR. SEE: 10 Q. In Table 7 of Dr. Jick's paper, Dr. Healy, do 11 you have that there? 12 A. I don't have it here. It could be in this 13 folder if you want me to hunt through? I'm not sure 14 I've got it. 15 Q. Maybe I can just ask. 16 A. Yeah. 17 Q. You came up with 187 patients per 100,000 for 18 Prozac. That's a conversion of Dr. Jick's numbers. 19 He gives the numbers per 10,000 and you converted them 20 over to 100,000? 21 A. Yes. 22 Q. And so you could just do the same thing with 23 the numbers of any of these other numbers -- 24 A. Yes. 25 Q. -- in that table? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 669 1 A. Yes, you could. 2 Q. It would be the same thing? 3 A. Yes. 4 Q. All right. So the -- I better get you a copy 5 so we're sure we're on the same page. 6 THE COURT: Mr. See, what exhibit number is 7 this going to be? 8 MR. SEE: Dr. Jick's paper? It has not been 9 marked as an exhibit, Your Honor. It certainly can 10 be. 11 MR. VICKERY: It is in the plaintiffs. Let me 12 dig it out. 155. 13 MR. SEE: 155, Your Honor. 14 THE WITNESS: I actually have it here, Mr. See. 15 Q (By Mr. See) Very good. Thank you very much. 16 Would you turn to Table 7? 17 A. Happily. 18 Q. Are you there? 19 A. Yes, I am. 20 Q. Okay. Now, actually the table for Fluoxetine 21 says 19, but that's just the number rounded off from 22 187, just to get it to -- 23 A. Yes. 24 Q. -- per 100,00, correct? 25 A. Yes, that's right. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 670 1 Q. Now, the equivalent rate for the antidepressant 2 Mianserin, would be 161 per 100,000, correct? 3 A. That's correct, Mr. See. 4 Q. 161 per 100,000. And the number for Trazodone, 5 if you do the conversion, would be 148 per 100,000; is 6 that correct? 7 A. That's correct, Mr. See. 8 Q. And just to take one more, the number for 9 Flupenthixol -- 10 A. Flupenthixol. 11 Q. Flupenthixol, which is F-L-U-P-E-N-T-H-I-X-O-L. 12 A. Yes. 13 Q. The corresponding number of that would be 12 14 per 100,000; is that correct? 15 A. Yes, that's correct. 16 Q. Now, Dr. Healy, what I want to ask you and what 17 I want you to tell the Court is this: You have just 18 made an analysis of using Dr. Jick's numbers comparing 19 187 per 100,000 suicides with Prozac with this number 20 that you came up with in your draft manuscript of 15.8 21 suicides per 100,000 in moderately to mildly depressed 22 people, correct? 23 A. Absolutely, yes. 24 Q. So 187 compared to 15.8? 25 A. Yes. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 671 1 Q. And from that you reason that that is evidence 2 that Prozac causes suicide, right? 3 A. That's part of my evidence, Mr. See. 4 Q. That's the part I'm asking you about. 5 A. All right. 6 Q. Now, let's go on. 7 A. Yes. 8 Q. By the same reasoning of 161 per 100,000 on 9 Mianserin, a different antidepressant -- 10 A. Yes. 11 Q. -- you would also conclude from your reasoning 12 process, comparing 161 to 15.8 that Mianserin causes 13 suicide, correct? 14 A. No. I would have to explain why not, Mr. See. 15 Would you like me to explain? 16 THE COURT: Well, whether he would or not, I 17 would. 18 THE WITNESS: Right. Your Honor, when Dr. Jick 19 later controlled for confounding factors, the figure 20 for Fluoxetine stays at 187. The figure for all three 21 of the other antidepressants that he has mentioned 22 fall. 23 I might also point out to Your Honor, that two 24 of the three antidepressants that he has referred to 25 in the table have not been licensed by the FDA in this PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 672 1 country, and I might also point out to Your Honor, 2 that one of them, Flupenthixol, is a notable causer of 3 akathisia. 4 Q (By Mr. See) Just one follow-up to that, 5 Dr. Healy. You said when Dr. Jick controlled the data 6 for confounders, that result appears in Table 6, 7 doesn't it? 8 A. It does. 9 Q. And that is a result, because of the 10 controlling for confounders, where the confidence 11 interval done at 95 percent significance includes the 12 number one, correct? 13 A. It does. 14 Q. And even as you sit here today, I think you 15 have said in your sworn declarations, that you have 16 not and are not capable of calculating whether the 17 confidence interval would include one for the Table 6 18 results at either a 96 percent significance level or 19 an 85 percent significance level, correct? 20 A. That's correct. 21 MR. SEE: That's all, Your Honor. 22 THE WITNESS: Can I add to this, Your Honor? I 23 would like to add one further point to this. 24 THE COURT: You may. 25 THE WITNESS: When the British Medical Journal PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 673 1 introduced the notion of confidence intervals, and 2 they were the journal that introduced them first into 3 the field, they said that confidence intervals should 4 only be applied to one of the tables in the paper. In 5 essence, they should not be applied to all of the 6 tables. In this case, if that advice had been 7 followed, the figure of 2.1 would stand for Fluoxetine 8 in Table 6 without any confidence interval at all. 9 The other point to mention here is that the 10 figure of 2.1 is the most reliable figure for 11 Fluoxetine that we have from Table 6. The comparable 12 figures for all of the other antidepressants that 13 Mr. See has referred to here this morning, when 14 controlled for these confounding factors, they fall. 15 The figure for Fluoxetine does not fall. 16 THE COURT: Any further questions, Mr. See? 17 MR. SEE: I have no questions for the witness, 18 Your Honor. 19 THE COURT: Well, I have a few questions. 20 Are you then saying, Dr. Healy, that in using 21 valid and recognized scientific methodology that you 22 can interpret or reinterpret the Jick study to support 23 your opinion regarding causation? 24 THE WITNESS: Your Honor, as from the start, 25 and I hope I will get the opportunity during the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 674 1 course of this hearing, to outline my reasons for 2 cause and effect. I believe the strongest evidence 3 comes from challenge, dechallenge, and then challenge, 4 dechallenge, and rechallenge. The epidemiological 5 evidence drawn from Dr. Jick's paper, which was not 6 designed in the first instance to answer the question, 7 does Fluoxetine cause suicide, is extremely strong 8 evidence that points that way. 9 We have been able to supplement Dr. Jick's 10 paper with further epidemiological evidence that has 11 been presented to the Court, which I think, in its own 12 right, also proves causation. 13 THE COURT: But are you then reinterpreting the 14 Healy study to support your opinion of causation? 15 THE WITNESS: By "the Healy study," you mean, 16 Your Honor -- 17 THE COURT: I'm sorry, I meant the Jick study. 18 THE WITNESS: If one supplements the Jick 19 figures, which I have no reason to doubt, and which no 20 one else has cast any doubt on, and compares these to 21 the figures that we have derived from epidemiological 22 work that I have been involved in, then the evidence 23 for causation from these figures becomes extremely 24 strong, Your Honor. Yes. 25 THE COURT: Okay. Now, putting aside the Jick PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 675 1 study, have there been any epidemiological studies at 2 all that have conclusively determined that Prozac 3 either does or does not cause suicide? 4 THE WITNESS: There has been no study that has 5 been -- no epidemiological study that has been 6 designed specifically to answer this question. This 7 is unfortunate as the Jick study has shown how easily 8 this could have been done. It did not require a great 9 input of money. It did not require a great deal of 10 time. It did not require a great deal of personnel to 11 run this particular study. This study could have been 12 run by Eli Lilly or any other drug company to see how 13 their particular antidepressant stacks up on this 14 issue. 15 THE COURT: Mr. See, do you agree that there 16 has been no such epidemiological study that has 17 conclusively determined one way or the other whether 18 Prozac causes or does not cause suicide? 19 MR. SEE: Conclusively is a difficult word. I 20 suspect you would find it hard to find a scientist 21 anywhere in the world on any issue that will say 22 conclusively. I will tell the Court that there are a 23 number of epidemiology studies that show that Prozac 24 has no higher risk of suicide than any other 25 antidepressant. There is that data. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 676 1 THE COURT: Which ones are those? 2 MR. SEE: Could I make a request to the Court? 3 THE COURT: Pardon me? 4 MR. SEE: Could I make a request to the Court? 5 In that they were part of my cross-examination for 6 Dr. Healy should he be permitted to testify. May I 7 submit them in camera as work product? 8 THE COURT: Well, we'll take it up later then. 9 THE WITNESS: Could I also add this one further 10 point, Your Honor, that may be worth mentioning? The 11 epidemiological work that I have been involved with 12 bears directly on Dr. Jick's own work in that both 13 were conducted in primary care in the United Kingdom. 14 So there's a peculiar relevance to the work that I 15 have submitted to Your Honor on Monday afternoon on 16 this issue of causation. 17 THE COURT: In the Rosenbaum study, there's a P 18 value of .07? 19 THE WITNESS: That is correct. 20 THE COURT: And it's stated that, I think 21 Page 22 of Mr. Vickery's latest memo. It says, "The 22 relative risk of suicidality was 3.3 and then 23 (95 percent CL 0.9, 12.2), P-0.07." 24 So does that mean that -- that a fact of 25 93 percent that there would be -- it would be PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 677 1 significant? 2 THE WITNESS: Yes, it does, Your Honor. What 3 it means is this: If Your Honor was to put money on 4 the issue as to what the true figure was, you would be 5 well advised to put your money on the figure of 3.3. 6 However, if one wanted to be a little more exciting, 7 the actual -- the actual analysis of this particular 8 study would permit Your Honor to go as high as 12.9 9 times higher without being absolutely sure of losing 10 your money. 11 THE COURT: One final question then. When you 12 have several different studies that each have certain 13 confounding factors, but still suggest that there is 14 an otherwise significant causal relationship, is it 15 scientifically permissible to consider them? 16 THE WITNESS: Oh, I think it is. It's not 17 only -- on an issue of this importance, it is not only 18 scientifically permissible, it's morally obligatory. 19 THE COURT: Either counsel have any further 20 questions in respect to the Court's questions? 21 MR. VICKERY: I do not, Your Honor. 22 MR. SEE: I have no questions for the witness, 23 Your Honor. 24 THE COURT: All right. Thank you. You may 25 step down, Dr. Healy. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 678 1 Counsel, I think you said you would like to 2 have some argument, Mr. See? 3 MR. SEE: I would, Your Honor. 4 THE COURT: Very well. 5 MR. VICKERY: Your Honor, before he does that, 6 since it is my motion, can I go first? I mean, since 7 it is my burden? 8 THE COURT: Yes, you may. 9 MR. VICKERY: I will tell the Court that I have 10 delivered to Mr. See this morning, a copy of 11 Dr. Pert's CV, which we got by E-mail last night and 12 I'd like to tender -- 13 THE COURT: I would like to say, as far as 14 Dr. Pert goes, that the Court has decided that the 15 Court is not going to rely on the testimony of 16 Dr. Pert. Lilly had received no notice regarding 17 Dr. Pert, and it would be unfair to consider 18 Dr. Pert's testimony in that regard. 19 MR. VICKERY: Very well. Your Honor, what we 20 have seen over the past hour or so of examination by 21 Mr. See illustrates the wisdom of what the Supreme 22 Court said in the Daubert opinion itself. At the 23 conclusion of that opinion, they were addressing the 24 question of whether by abandoning the notion of 25 general acceptance that was -- that adhered in Fry vs. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 679 1 The United States and whether by, in effect, 2 liberalizing the admission of expert evidence, which 3 was the intent of the Supreme Court, whether by doing 4 that they ran the risk, quote, that it would result in 5 the abandonment -- I'm sorry, that it would result in 6 a free-for-all in which befuddled juries are 7 confounded by absurd and irrational pseudoscientific 8 assertions, end quote. 9 What the United States Supreme Court said about 10 that is in this regard, the respondent seems to us to 11 be overly pessimistic about the capabilities of the 12 jury and of the adversary system generally. Vigorous 13 cross-examination, presentation of contrary evidence, 14 and careful instruction on the burden of proof are the 15 traditional and appropriate means of attacking shaky, 16 but admissible evidence. 17 I think that what is abundantly clear is what 18 we have just seen is not voir dire examination at all 19 by Mr. See, but it is cross-examination, and he has 20 illustrated the wisdom of the Supreme Court's 21 teachings and the fact that he himself is, indeed, 22 prepared to cross-examine this witness. 23 We had an echo of this, if you will, two months 24 ago with the Ninth Circuit in Kennedy vs. Collagen, 25 when the Court had excluded evidence based on a PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 680 1 Daubert challenge in a jury trial, granted summary 2 judgment and the Ninth Circuit reversed and said that 3 the weight of this evidence, if it is scientifically 4 reliable and it's relevant to the task at hand, the 5 weight to be given to it is for the jury in a jury 6 trial case. 7 So I think that that is where we are on this 8 issue that very clearly the scientific methodology is 9 sound and there is compelling evidence. I would only 10 finally mention that Kennedy vs. Collagen also said 11 that it was an abuse of discretion, and therefore, 12 error for the Court to ignore the internal 13 documentation of the defendants which tended to 14 establish causation. And we have that in abundance 15 here. 16 For that reason, I submit that we have more 17 than carried our burden under Daubert and that there 18 should be no question about the jury deciding what 19 weight to give to Dr. Healy's testimony. Thank you. 20 THE COURT: Thank you. Mr. See. 21 MR. SEE: Your Honor, I have two major points 22 to make. The first one is historical, somewhat 23 procedural. After I took Dr. Healy's deposition and 24 in accordance with the court's schedule, a summary 25 judgment motion was filed. That was my vehicle to PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 681 1 challenge Dr. Healy's qualification -- not 2 qualification, because that's not really the challenge 3 at all. To challenge the methodology Dr. Healy 4 applied to conclude that Prozac causes suicidality and 5 homicidality in humans. 6 At his deposition, as we set forth in our 7 initial pleadings, Dr. Healy told me what his 8 methodology was, what he relied upon, and what he told 9 me in his deposition was I rely on three things. I 10 rely on my case report, the article that Your Honor 11 has heard Dr. Healy give testimony about, that he 12 calls a challenge/rechallenge, but, in fact, as he has 13 testified, it involved two patients only. 14 They were first given Prozac and then it was 15 stopped, and after that, they were given a different 16 antidepressant, so they were not rechallenged with 17 Prozac. So that was one thing he relied upon, and he 18 also said I rely on other case reports that also used 19 this kind of method and we've talked about those 20 today, and I'll bring those up again. So that was the 21 second thing. And the third thing he said he relied 22 upon was Dr. Jick's study, an epidemiological study. 23 So those were the three things he told me about in his 24 deposition, and that's what we set forth in our 25 motion. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 682 1 THE COURT: Well, I think you would have to 2 look at his declaration. It's much broader than that. 3 MR. SEE: What I'm talking about, Your Honor, 4 is when I took his deposition and asked him, Doctor, 5 you've now formed this opinion. Now that you've got 6 that opinion, on what did you rely to come to that 7 conclusion? He formed his opinion based upon the 8 methodology he told me about. 9 THE COURT: I'm referring to his declaration 10 filed in opposition to your motion, the first 11 declaration. 12 MR. SEE: Well, yeah, I think you do have to 13 take it into account, but here's what I want to tell 14 the Court. The case law as we cited says you can't 15 rely upon case reports that are reports of doctors 16 observing individual patients in their practice or 17 series of patients, can't rely upon case reports to 18 come to cause and effect conclusions. 19 THE COURT: Well, did you read the Mendes-Silva 20 case out of the District of Columbia circuit? 21 MR. SEE: Mendes-Silva doesn't ring a bell 22 right as I stand here. I know that there are legion 23 cases that say what I just said. 24 THE COURT: Well, in that case they did permit 25 the case studies because there were no epidemiological PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 683 1 studies that conclusively determined one way or the 2 other cause and effect. 3 MR. SEE: All right. What we litigated 4 because -- and I continue to submit to the Court, the 5 vast weight bulk of authority says you can't use case 6 reports to come to a scientifically valid conclusion 7 about cause and effect. What we litigated was whether 8 Dr. Healy could rely upon Jick. 9 THE COURT: And I think at that time we entered 10 a motion in limine order to that effect, too. 11 MR. SEE: Yes, sir. 12 THE COURT: At that time having concluded that 13 the Jick study was reliable. 14 MR. SEE: Yes, sir. So we've been litigating 15 about the Jick study, and I dare say, and I could be 16 wrong of course, but it is my proposition, and I may 17 be wrong, that the reason that Dr. Healy's testimony 18 survived from the time our motion was filed up until 19 yesterday afternoon was because of Dr. Healy's 20 reassurance to the Court in declarations in response 21 to our raising the issue about confounders, not being 22 able to rely on something if it was filled with known 23 confounders, and about not being able to rely upon 24 something if it's not statistically significant, that 25 even if the confidence level is lowered, Dr. Healy PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 684 1 reassured the Court that it will be significant. I 2 haven't done the calculations, but I know it will. 3 Now, I believe that's why, at least as I read 4 the Court's orders, why Dr. Healy's testimony 5 survived. 6 THE COURT: No, there were other reasons given 7 also. 8 MR. SEE: Now we know that the Jick study Table 9 6 is not statistically significant at the 90 or the 85 10 level. And here's my point about all of this, Your 11 Honor, the historical part. Until yesterday afternoon 12 that's what Lilly has been litigating with the 13 plaintiff about. Now, yesterday afternoon, Dr. Healy 14 said on the stand and kind of turned to the Court and 15 said, well, Jick's irrelevant. All this confidence 16 interval business is irrelevant. In response to the 17 Court's request that Dr. Healy respond, I submit, 18 Dr. Healy did not respond. What Dr. Healy did was 19 avoid. 20 Oh, well, that Jick -- that's not so important. 21 I don't know why we're so concerned with Jick all 22 along. Now this is what I really rely upon. I submit 23 to the Court that Dr. Healy has changed the 24 methodology that he's employing and it's not the same 25 as he said in his deposition. Now he says Jick PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 685 1 doesn't matter, and that's not fair. That violates 2 the discovery rules about expert disclosure, and I 3 want to offer the Court a case -- 4 THE COURT: I think he's still saying that Jick 5 has been supplemented by his own studies. He's not 6 saying it's irrelevant. 7 MR. SEE: Well, his own study meaning the 15.8, 8 the study that's in his manuscript? 9 THE COURT: Well, and a number of others, 10 Rosenbaum and several others that he's mentioned in 11 his declaration. Isacsson. 12 MR. SEE: Prozac is not in Isacsson. 13 THE COURT: I understand that, but it 14 corroborates the findings in Jick's. 15 MR. SEE: So my first point is, I believe that 16 Dr. Healy has modified his method from that he 17 disclosed in his report and from that, that we have 18 been litigating all along that he should not be 19 permitted to do that. The case that I would offer the 20 Court is, In Re: 3-Mile Island litigation. And I'll 21 hand the Court's clerk a couple of copies of that. 22 It basically stands for the proposition. It's 23 a very thick case, but I put clips and highlighted the 24 part that I think talks about this issue. What it 25 says is that the expert, once a summary judgment PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 686 1 motion has been filed and his methodology has been 2 attacked, ought not be able to say, oh, well, don't 3 really look at that too much. I've got this new 4 methodology. I believe that the witness ought not be 5 able to do that. That's not what's contemplated by 6 the discovery disclosure rules and that's what's been 7 done here. 8 THE COURT: Well, you know, I think if you read 9 his declaration, if you read the Court's orders, 10 you'll find that he did not rely solely on Jick's. 11 MR. SEE: I understand. I understand that, 12 Your Honor, but the fact -- 13 THE COURT: He is saying that Jick still is 14 relevant and that he supplemented it. 15 MR. SEE: Well, it is still my position with 16 the Court, Jick and the results in Jick have been used 17 by Dr. Healy in an unscientific way. That the law 18 supports that. The science supports that. The only 19 result that can be considered out of that study is not 20 statistically significant, even if you, as Dr. Healy 21 wants to do, go in after the fact and say, well, this 22 is real important. I think you ought to consider a 23 lower level. Even after you do that, it's not 24 significant. Scientists don't consider results that 25 are scientifically significant as being evidence of PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 687 1 causation. So that's the point on the procedural 2 point. 3 Now, I've got a substantive part. I listened 4 carefully to what Dr. Healy said yesterday and here's 5 what he said. He said there are three ways to get to 6 causation. You can rely on randomized controlled 7 clinical trials, you can rely on epidemiological 8 studies, and you can rely on challenge/rechallenge. 9 Now, I'm mindful of what the Court has said and 10 the questions the Court has asked today, but I submit 11 to the Court, number one, the plaintiffs have not 12 submitted any scientifically valid results from 13 randomized-controlled clinical trial. I think they 14 admit that. So that one is out. With respect to 15 epidemiology studies -- 16 THE COURT: Well, actually, on randomized 17 control, isn't that what Healy himself used in his 18 1985 clinic? 19 MR. SEE: No, sir. Dr. Healy? The only thing 20 I know that Dr. Healy has done himself -- 21 THE COURT: No, I meant to say Lilly in their 22 1985 memo. 23 MR. SEE: Your Honor, the 1985 memo is the memo 24 that -- those are, in fact, results from controlled 25 clinical trials, bunched all together, and that's the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 688 1 Exhibit 1114 and 1116 that I just questioned Dr. Healy 2 about. And all of those accumulated numbers, that's 3 where the 5.6 comes from, and Dr. Healy admitted on 4 the stand that those numbers didn't take into account 5 patient years at risk, which was the appropriate way 6 to analyze the number, and I had him read off the 7 table showing that some of the comparison 8 antidepressants were five patient years at risk, but 9 Prozac was 400 some odd patient years at risk and this 10 number didn't take that into account. 11 So I submit that that number is not a number 12 that is a valid comparison from controlled clinical 13 trial results. Dr. Healy also referred to the 242 14 patients on Prozac and 243, or whichever it was, on 15 the other antidepressant. There were two suicides in 16 one group and zero in the other. I asked him, do you 17 know if that's a statistically significant difference 18 because you have to test statistical significance 19 every time you do a study like that? It's because 20 there's always the chance that a random application of 21 people, when you pull people in to do a study, you get 22 sicker people on one side than the other. 23 The result might be due to chance. That's why 24 scientists do statistical significance testing and he 25 says, no, he didn't do statistical significance PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 689 1 testing. He doesn't know whether that's a significant 2 number or not, so I submit that's not a result from a 3 randomized clinical trial to use. 4 Going to the epidemiological studies, I still 5 believe that the only one that's been put forward is 6 Jick and the only result that can be considered is 7 Table 6, and that's not statistically significant even 8 at a lower significance level. 9 So I submit to the Court from the plaintiffs' 10 perspective, that supporting the epidemiology side is 11 out. He has one left, which is challenge/rechallenge, 12 and I also listened carefully to what articles he was 13 talking about, and asked how do you use that? Where 14 do you go on challenge/rechallenge? 15 He mentioned his own challenge/rechallenge, 16 which he admitted the patients -- two patients only 17 got Prozac and later got a different antidepressant. 18 I submit that's not a challenge/rechallenge protocol 19 that proves anything about Prozac. So that's 20 eliminated. 21 The other papers we talked about, the Wirshing 22 and the Rothschild papers, what do they show? First 23 of all, Wirshing was not a challenge/rechallenge at 24 all. It was a report of five patients. Again, a case 25 report. Not a study. A report on five patients that PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 690 1 had been administered Prozac, and again, these 2 patients, with their own problems, with their own 3 pre-existing disease and history and so on, five 4 patients that Dr. Wirshing and his colleagues observed 5 became akathisic when they were given Prozac. And 6 what did we see about them? Pacing, hand wringing, 7 movement. And then we look at the Rothschild paper, 8 which was a challenge/rechallenge paper, and what did 9 we see with each one of the three patients; pacing, 10 hand wringing, movement, akathisia. 11 Now, here's my point, Your Honor. The only way 12 Dr. Healy, in a scientifically valid way gets to 13 causation, by his methodology, is that Prozac causes 14 akathisia, which results in suicide and then 15 accompanying homicide. That's how he gets there. But 16 look at the papers he relies upon to get there. The 17 challenge/rechallenge paper are two, Rothschild and 18 Healy. 19 We've already said Healy wasn't really a 20 challenge/rechallenge with Prozac because they didn't 21 get Prozac the second time. So let's look at 22 Rothschild. We read off the description, the symptoms 23 that occurred in each of those patients, the three 24 patients. Obviously, physical, noticeable 25 psychomotor, active hand wringing, pacing, couldn't PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 691 1 stand still symptoms. Although Dr. Healy has told the 2 Court a couple of different things, he put in his 3 declaration this statement, "Akathisia is a clear-cut 4 phenomenon." Sworn affidavit by Dr. Healy. 5 Here's the point. The Supreme Court said in 6 Daubert that not only do you need to have 7 scientifically reliable evidence and on a scientific 8 note, I would strongly submit to the Court that what's 9 been proposed to get through the challenge/rechallenge 10 business, the Healy study, that's not a rechallenge 11 with two people, and Rothschild's with three against 12 the hundreds and thousands of people that have been in 13 studies is not scientifically reliable. 14 I'll set that aside for one second. The 15 Supreme Court also said the testimony of the expert 16 and the method has got to fit the facts of the case. 17 Fit. As important as reliability, it's got to fit the 18 facts. So far we have heard -- 19 THE COURT: I remember you writing all that. 20 MR. SEE: Yes, sir. So far we've heard the 21 testimony of the principal fact witness, Mr. Forsyth, 22 Jr., and I tell the Court as an officer of the Court, 23 there is no notation in the Castle Medical Center 24 records whereby the way Mr. Forsyth went in as a 25 depressed patient, who said he was having suicidal PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 692 1 feelings. 2 Dr. Neal has testified in deposition, and I 3 suspect will say the same thing when he gets here, 4 this man was under close scrutiny all the time. He 5 was there and there is no akathisia. Dr. Neal will 6 say he didn't have akathisia, and I'm the doctor that 7 saw him every day. None of the health care people, 8 the mental health people who were writing notes down 9 about how this man had noted that he had akathisia. 10 THE COURT: But you did bring out that he had 11 suicidal thoughts. 12 MR. SEE: Yes. He said he had suicidal 13 thoughts the past month. He had been taking Prozac 14 for two days. He said, my depression has been getting 15 worse the last two months and I've been having 16 suicidal thoughts the past month. He said that on the 17 evening of February 24th. 18 THE COURT: And he was afraid to stay in his 19 house that night. 20 MR. SEE: That's correct, before he took 21 Prozac. 22 THE COURT: No, this was -- as I recall, and I 23 may be wrong, but I thought he said he was afraid to 24 stay in the house another night, meaning that that day 25 that he went in the hospital he had already taken PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 693 1 Prozac. 2 MR. SEE: I believe Bill Forsyth, Jr. said 3 that. I believe he did say that. 4 So my point, Your Honor, looking at the Supreme 5 Court opinion in Daubert, if Dr. Healy's opinion -- 6 just put aside the scientific validity. I submit it's 7 not there. If Dr. Healy's opinion operates that 8 Prozac causes akathisia and that results in suicide 9 and homicide, it doesn't fit and there's no evidence, 10 there's no evidence in this record that it does. 11 In fact, the affirmative evidence in the record 12 is exactly to the contrary. Mr. Forsyth, Jr.'s 13 testimony that he gave about how his father was the 14 evening of March the 3rd, that is the day before he 15 died; calm, subdued, sitting, not pacing, not running 16 around. The fit isn't there for Dr. Healy's theory 17 and that's not a jury argument because Dr. Healy's 18 method of getting from here, Prozac, to there, 19 suicide, goes through akathisia. That's how he 20 reasons. That's why he says that these articles about 21 akathisia are relevant. 22 THE COURT: But Dr. Healy also testified and 23 stated that unless you're looking for it, you don't 24 notice the symptoms of akathisia, and he quoted from 25 Dr. Van Putten, I believe it was. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 694 1 MR. SEE: I heard him say that. I heard him 2 say that. I will tell Your Honor, Dr. Neal will 3 testify that Mr. Forsyth was under, not just normal 4 scrutiny, but because he was potentially suicidal, 5 under close scrutiny, and he had none of those 6 symptoms and there will be no evidence that he did. 7 And if Mr. Vickery has some, I'm sure he'll tell you, 8 but there won't be any. I could have missed something 9 in the record, but, you know, I did my best. 10 THE COURT: And he was also under sedatives? 11 MR. SEE: Say? 12 THE COURT: I said, he was also under 13 sedatives? 14 MR. SEE: He had been taking Xanax for many 15 months. Dr. Roberts prescribed Inderal for anxiety 16 and Desyrel for sleep, and he continued that regimen 17 in the hospital, that's correct, and he took that 18 every day that he was in the hospital, that's right. 19 But if the theory is akathisia makes you so miserable 20 and you feel so bad and you're so bothered that you 21 engage in a suicidal act, there's no evidence that 22 this man felt that way. Subjective feeling of 23 restlessness, where? There's no testimony. None. 24 Mr. Forsyth said that to no one. Dr. Healy may say -- 25 THE COURT: He had to go to the hospital that PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 695 1 day. He had to leave that hospital when he wanted to 2 leave. 3 MR. SEE: He wanted to go to the hospital 4 before he ever took Prozac. 5 THE COURT: He went to the hospital that very 6 day. 7 MR. SEE: He had episodes when he wanted to go 8 to the doctor that very day, too. 9 THE COURT: That's correct. 10 MR. SEE: Wanting to go to the hospital, I 11 submit, is not akathisia. It is clear the man was 12 very depressed, very disturbed, had a very serious 13 state of mind. About that, there is absolutely no 14 question, and the evidence is and will be he had the 15 same state of mind before he ever took Prozac. He 16 called his doctor in L.A. and said, boy, I feel like I 17 need to be in the hospital. That was before Prozac. 18 So I think the bottom line is, you can't -- you 19 have to fit your theory, your methodology of coming to 20 scientific conclusion about causation to the facts of 21 the case, and it doesn't fit this case because there's 22 no akathisia. 23 Akathisia is not invisible. I mean, I think 24 the Court has to take Dr. Healy at his word in his 25 sworn declaration addressed to the Court. Akathisia PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 696 1 is a clear-cut phenomenon. And I think the Court 2 needs -- I think the Court needs to take into very 3 careful consideration -- 4 THE COURT: I think he explained what he meant 5 by that, too. 6 MR. SEE: I just read the words in the 7 declaration and I think they ought to be taken at 8 their plain meaning. I think they are intended to be 9 read at their plain meaning. 10 THE COURT: Thank you. 11 MR. SEE: Thank you, Your Honor. 12 THE COURT: Mr. Vickery. 13 MR. VICKERY: Your Honor, I don't know that I 14 can add anything at this juncture. I think the 15 Court's questions -- 16 THE COURT: Well, you haven't really submitted 17 much either. 18 MR. VICKERY: Well, I hope that the materials 19 that we labored greatly over over the weekend have 20 been assistance to the Court. I think fundamentally 21 Mr. See and I disagree on a point of federal civil 22 procedure. He seems to be of the view that even 23 though the Court has thriced denied his motion for 24 summary judgment, that it's sort of like always 25 pending out there. I don't think it is. I think it PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 697 1 is very clear that the Court has an understanding of 2 it. 3 What he has just illustrated for us is that in 4 addition to being capable of conducting very vigorous 5 cross-examination, he is also capable of making very 6 forceful arguments, but those arguments, I submit to 7 the Court, need to be addressed to the jury at the 8 conclusion of the case rather than in the context that 9 we find ourselves in now. 10 THE COURT: The Court is going to take a short 11 recess and then it will make its ruling on this 12 matter. 13 (Whereupon, a recess was taken at 10:10 a.m.) 14 (Whereupon, the following proceedings were had 15 in open court out of the presence of the jury.) 16 THE COURT: Well, first the Court wishes to 17 commend Mr. See for his well-reasoned argument, but 18 the Court is not persuaded by it. The Court will make 19 a brief summary of its order now, but will issue a 20 more elaborate written order later. 21 The Court first notes that Lilly was on notice 22 of this issue before this Court's most recent order 23 and the Court is concerned about the timeliness of the 24 latest Jick declaration. Prior to Lilly's renewed 25 motion for reconsideration, the Court had said in its PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 698 1 order denying Lilly's motion for reconsideration that 2 Table 6 might be significant at 90 percent or 3 85 percent and the Healy declaration, which had been 4 included earlier, had recited that the Jick's study 5 would be significant, at least, at 90 percent. 6 Case law has established that epidemiological 7 studies are not the only means to establish causation. 8 Daubert itself so holds. In the Kennedy case, the 9 Court noted that other circuits have found that it is 10 scientifically permissible to reach a conclusion on 11 causation without epidemiological studies. That's a 12 Ninth Circuit 1998 case. 13 Kennedy, Fourth Circuit, 1995 case held that 14 under the Daubert standard, epidemiological studies 15 are not necessarily required to prove causation as 16 long as the methodology employed by the expert in 17 reaching his or her conclusion is sound. 18 In Heller, Third Circuit, 1999 case, given the 19 liberal thrust of the Federal Rules of Evidence, the 20 flexible nature of the Daubert inquiry, and the proper 21 rules of the judge and jury in evaluating the ultimate 22 credibility of an expert's opinion. We do not believe 23 that a medical expert must always cite published 24 studies in general causation in order to reliably 25 conclude that a particular object caused a particular PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 699 1 illness. 2 Here there is an absence of epidemiological 3 studies that conclusively determine whether a causal 4 relationship exists. In Mendes-Silva, the DC Circuit, 5 distinguish the Richardson case which involved 6 Bendectin because no epidemiological studies existed, 7 plus there was no wealth of epidemiological studies 8 that had reached the conclusion contrary to the 9 plaintiff's expert. 10 Ambrosini, DC Circuit, '96 case, noted that 11 there was no overwhelming body of contradictory 12 epidemiological evidence to the expert's conclusion. 13 In response to the FDA concerns, Lilly had 14 offered to conduct a 200 person rechallenge -- 200 15 person rechallenge study, but later dropped the study, 16 so Lilly did have an opportunity to conduct such a 17 study. And in Beasley's meta-analysis could have 18 included certain data to address the suicide issue. 19 In Plaintiffs' Exhibit 108, FDA epidemiologist, 20 Dr. Graham, commented that it could be argued that 21 these exclusions are not justified or appropriate 22 under a meta-analyst -- analysis where data 23 contributing to both the enumerator and the 24 denominator of Fluoxetine were collected and are 25 analyzable. Were those cases included, substantial PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 700 1 differences in suicidality between drugs could have 2 been observed. 3 There's also difficulty in conducting such a 4 study by plaintiffs' expert involving ethical 5 dimensions and costs. The Kennedy case noted that 6 epidemiological studies would be almost impossible to 7 perform. Those patients who have collagen injections, 8 do not seek treatment from rheumatologists for their 9 reactions. 10 Turning to Dr. Healy's scientific methodology. 11 He did testify that he can reinterpret the data from 12 this study to corroborate his opinion and relied on 13 the Rosenbaum, which has 93 percent statistical 14 significance, shows a relative risk of 3.3. The Court 15 notes in the Turpin decision and Isacsson, which do 16 not look at Fluoxetine, but did find the same rank 17 ordering of other drugs in terms of their relative 18 risks of suicide, as was found in Jick's study Tables 19 3 and 4. 20 Mann study reanalyzed Rosenbaum data and found 21 increased suicide rate, but did have confounding 22 factors of multiple antidepressants. 23 Lilly's own 1985 memo noted suicide rate on 24 Fluoxetine is 5.6 times higher than under three other 25 antidepressant drugs. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 701 1 Dr. Healy analogized from his own research on 2 serotonin and akathisia in reaching his conclusion 3 that there is a causal relationship, and he's also 4 published many articles. We have a 1999 article that 5 refers to the Jick study. He's done research that was 6 not prepared for litigation. He's also attended many 7 conferences on the subject and lectured on the subject 8 to hundreds of scientists and published case studies 9 as well as authoring research into akathisia, and he 10 has conducted a challenge/rechallenge test. 11 So the Court concludes under Daubert, number 12 one, that Dr. Healy's opinion on causation is based on 13 scientifically valid principles and that it would just 14 assist the trier of fact; that it would fit the facts 15 of this case; and that it is relevant. So the Court 16 will permit Dr. Healy to testify. 17 Now, the Court is not going to permit the 18 defendant to cross-examine Dr. Healy on the latest 19 Jick declaration or any of the Jick declarations. 20 So we'll take a short recess to allow the jury 21 to come in. 22 (Whereupon, a recess was taken at 10:40 a.m.) 23 (Whereupon, the following proceedings were had 24 in the presence of the jury.) 25 THE CLERK: Civil No. 95-00185 ACK, Susan K. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 702 1 Forsyth, et al. versus Eli Lilly and Company, et al. 2 MR. VICKERY: Good morning, Your Honor. Andy 3 Vickery, Karen Barth, and Roy Chang for the 4 plaintiffs, Susan and Bill Forsyth. 5 MR. SEE: Andy See and Michelle Mangrum and Ed 6 Burke for Eli Lilly and Company. 7 THE COURT: Good morning, ladies and gentlemen 8 of the jury. We apologize for the interruptions, but 9 there are some things we had to resolve so we will 10 proceed now. 11 Mr. Vickery, your witness. 12 MR. VICKERY: Yes, your Honor. Thank you, I 13 have asked her to come on in. This is Ms. Bobbie 14 Comstock. 15 THE CLERK: Please rise and raise your right 16 hand. 17 BARBARA COMSTOCK, 18 called as a witness on behalf of the Plaintiffs, after 19 having been first duly sworn to tell the truth, the 20 whole truth, and nothing but the truth, was examined 21 and testified as follows: 22 THE CLERK: Please state your name and spell 23 your last name. 24 THE WITNESS: Barbara or Bobbie Comstock, 25 C-O-M-S-T-O-C-K. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 703 1 THE COURT: You're going to have to speak up so 2 that we can all hear you. 3 THE WITNESS: Okay. Barbara Comstock, 4 C-O-M-S-T-O-C-K, and people call me Bobbie. 5 DIRECT EXAMINATION 6 BY MR. VICKERY: 7 Q. Ms. Comstock, where do you live? 8 A. I live in Maui. 9 Q. How long have you lived on Maui? 10 A. Oh, off and on over the last 35 years. We 11 spent ten years on the Big Island and most of the rest 12 of it on Maui. 13 Q. We have heard your name mentioned once briefly 14 in the trial already. Is it true that you and June 15 were very close friends? 16 A. Yes. 17 Q. Tell us, if you will, how you all became 18 friends. 19 A. Well, we had each prayed for another mature, 20 old-bag friend and we met at a women's fellowship at 21 church. Exceeding abundantly all I could think or ask 22 was the way God gifted me with the answer to that 23 prayer in June. 24 Q. I know this is tough for you and I won't keep 25 you any longer than I must. When was that? When did PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 704 1 you all become friends? 2 A. It was sometime in '91. Early '91. 3 Q. And did you -- what kind of things would you do 4 together? Give us an idea of the activities as 5 friends that you would engage in. 6 A. Well, we went to lunch a lot. We went to each 7 other's houses. We went to church together. We had a 8 women's fellowship at her house on Thursday nights. 9 We went to plays and dinner. Talked on the phone a 10 lot. I've never been a phone chatter, but with June, 11 I was. 12 Q. Sounds like you and your husband socialized 13 with Bill and June together; is that true? 14 A. Yes. 15 Q. Now, were the men as close as the wives were? 16 A. No. 17 Q. Okay. So really the cement was the two of you, 18 I guess? 19 A. Right. 20 Q. Were you the kind of friends that would share 21 your inner most thoughts and secrets with one another? 22 A. I think so. 23 Q. And we've heard testimony about there being a 24 point in time in which June and Bill were in a 25 difficult time in their marriage. Were you aware of PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 705 1 that? 2 A. Yes. 3 Q. Did she share that very openly and candidly and 4 confidentially with you? 5 A. Yes. 6 Q. Tell us, if you will, what you recall of her 7 sharing with you at that point in time when they were 8 in the bad part of it. 9 A. I think that June was confused and a little 10 frightened and perhaps angry sometimes, felt betrayed. 11 Q. At that point in time did she have a name 12 that -- you know, when she was sharing with you, her 13 most confidential friend, in anger or frustration, 14 what would she call her husband? 15 A. Old Bilious. 16 Q. Old Bilious? 17 A. Yeah. We talked about how that wasn't very 18 honoring, but if you look up the definition of Bilious 19 she thought it fit at the time. 20 Q. Okay. Did you and she discuss the kinds of 21 things that might be done to heal that broken 22 relationship? 23 A. Oh, yes. 24 Q. Was this over a long period of time? 25 A. Sure. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 706 1 Q. Were you close with her when, in the summer of 2 1992, Bill suddenly left and went back to the Mainland 3 for a while? 4 A. Yes. 5 Q. And what was her initial reaction when he did 6 that? 7 A. She was very hurt, confused. 8 Q. And over time did her reaction and attitude 9 about them being apart for a while change? 10 A. I think it was a relief to her not to have to 11 walk on eggshells, as she put it, but she wanted there 12 to be communication and reconciliation, and we prayed 13 about it and read things about it and, you know, 14 just -- she worried about it. 15 Q. Okay. And when Bill was there on the Mainland, 16 did you suggest someone that he might see to help him 17 through this time? 18 A. No, I didn't suggest it, but June and I prayed 19 that Bill would remember Tom Brady and get in touch 20 with him. 21 Q. Now, Dr. Brady is here in the courtroom. He 22 was your friend before; is that right? 23 A. Yes. And he met June and Bill when he had been 24 on a prior visit and that's what happened, I guess, as 25 well as I remember. Bill did remember Tom and get in PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 707 1 touch with him. 2 Q. Now, did there come a point in time in October 3 of 1992 when Bill asked June to join him on the 4 Mainland and continue therapy sessions with Dr. Brady? 5 A. Yes. 6 Q. Okay. And did she discuss that with you before 7 she went to do that? 8 A. Yes. 9 MR. VICKERY: Your Honor, a point of procedure, 10 based on the conference the other day, I told 11 Dr. Brady, since he is an expert, that he could be 12 here for -- because he's a friend of this lady. Does 13 the Court wish to exclude him since he will be 14 testifying? 15 THE COURT: Mr. See. 16 MR. SEE: Your Honor, I don't have any problem 17 with -- if Dr. Brady stays in the courtroom. 18 THE COURT: Thank you. 19 MR. VICKERY: Thank you, Your Honor. 20 Q. So how did she feel when Bill said come join me 21 in therapy with Tom Brady? 22 A. I think she had a mixture of feelings of 23 elation and apprehension. 24 Q. And did you have telephone reports back from 25 her while she was going through that process with PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 708 1 Dr. Brady? 2 A. Yes. 3 Q. And did she change in her attitude about the 4 marriage and her husband as they went through that 5 process? 6 A. Absolutely. 7 Q. Tell us about it. What change did she have? 8 A. She had hope. She had a new understanding of 9 how she could go on. You know, she had -- I guess, I 10 would say a humility and a forgiveness and love and 11 just a serenity. She was very excited. 12 Q. So her attitude changed? 13 A. Yes. 14 Q. And did she report to you as to whether his 15 attitude had changed as part of that process? 16 A. Well, she said that he dealt with a lot of 17 things and that he was much more tender and they could 18 communicate, which they hadn't been able to. 19 Q. Did you see them when they got back in December 20 of '92? 21 A. Yes. 22 Q. And how would you describe their relationship 23 at that point? 24 A. Improved. 25 Q. Did she still call him Old Bilious then? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 709 1 A. No, she often called him "My Bill," actually. 2 Q. And what did you, as her close friend, read 3 into the change of what she called her husband from 4 Old Bilious to my Bill? 5 A. I think that she had made a commitment to what 6 we know to be true, that God is supposed to be first 7 and your husband is supposed to be second, and she 8 hadn't been able to put him second before, but she was 9 happy to give him that preeminence, and she felt that 10 it was the right path that she was finally getting a 11 handle on. 12 Q. Did you remain in contact with your friend June 13 from December 7th, when they came back, until their 14 deaths in early March? 15 A. Yes. Not as much as before. 16 Q. Why not? Was she busy with something else? 17 A. She was busy with Bill and committed to helping 18 him, and he wanted -- he didn't want her away from 19 him. We weren't free to run around and hang out like 20 we used to because he needed her. 21 Q. And was she there for him? 22 A. Yes. 23 Q. Tell us about the last conversation you had 24 with her. When was it? 25 A. It was the morning that she went to pick him up PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 710 1 at the hospital. 2 Q. Want to take a sip of water? 3 Can you recall the conversation for us, please? 4 A. We met at her house early on Wednesdays for 5 prayer and she was getting ready to go catch the plane 6 and she said -- well, I said, "Does this mean we're 7 not going to fast and pray today?" Which we usually 8 did on Wednesdays, and she said, "You do it. I'm 9 going to go have Mexican food and I'm going to pick up 10 my Bill." And she was being -- she was very happy, 11 you know. She was kind of rascally when she said 12 that. 13 Q. Two more things, Ms. Comstock, and I'm done. 14 Tell us your impression of Bill Forsyth, and 15 particularly from the time they got back in December 16 of '92 until their deaths. 17 A. Well, he was depressed, but he was also a 18 giver. I have kind of an adopted son, not really a 19 son, but he was an old employee, and he kind of comes 20 to us for help and he was in a difficult situation 21 with his business finances and so on, and Bill had 22 offered to help at church because he was akamai about 23 things like that and I think June asked him if he 24 would help Tim or advise Tim, and Tim was also 25 depressed, so I remember that Bill called me and asked PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 711 1 if Tim was coming and he was just really sweet about 2 it. And that he and Tim got together and he helped 3 Tim and they had quite a rapport. And I didn't see 4 Bill too much, but I talked to him on the phone and I 5 saw him at Bill, Jr.'s wife's baby shower the last 6 time. 7 Q. Ms. Comstock, was Bill Forsyth, Sr. a good man? 8 A. I'm sorry? 9 Q. Was he a good man? 10 A. I think he was a good man. 11 Q. Have you had any interaction with Bill, Jr. or 12 with Susan since the deaths of their parents? 13 A. Sure. 14 Q. And can you tell us from your perspective how 15 that death has influenced them? 16 A. How it's influenced them? 17 Q. Yes, ma'am. 18 A. I think they're hanging onto God and they know 19 there's a time when we'll be together again, but it's 20 devastating. Their grandchildren will never grow up 21 with their grandparents and that's painful. 22 MR. VICKERY: I won't ask any more. Thank you, 23 Ms. Comstock. I'll pass the witness. 24 THE COURT: Mr. See. 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 712 1 CROSS-EXAMINATION 2 BY MR. SEE: 3 Q. Ms. Comstock, we do thank you for coming over 4 and I know it's difficult, but I also need to ask you 5 some questions, if you don't mind? 6 A. Okay. 7 Q. I take it that you and June were not only 8 friends, but if you had to identify the person on Maui 9 who was June's best friend, that would be you? 10 A. Yes. 11 Q. And is it correct that you and June shared the 12 same Christian beliefs? 13 A. Yes. 14 Q. And the same Christian way of life? 15 A. Yes. 16 Q. And you shared that together? 17 A. Yes. 18 Q. You and June attended the same church for a 19 time? 20 A. For a time, and then I went somewhere else and 21 she was still going. 22 Q. The church that you attended with her was the 23 Kumalani Chapel? 24 A. Yes. 25 Q. I apologize, but I do need to ask some PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 713 1 questions about what you know, as June's friend, about 2 her relationship with her husband and what she told 3 you. Did June tell you about an episode that took 4 place between she and Bill sometime before they moved 5 to Maui, an episode at the house they had in the 6 desert? 7 A. Yes. 8 Q. And was that a time when, as June told it to 9 you, she had tried to clear the air about her 10 relationship with Bill? 11 A. Yes. I mean, they were just having an argument 12 or something and they were both expressing how they 13 felt about things, I guess. 14 Q. Did she tell you that was about two years 15 before they moved to Maui? 16 A. I don't remember. 17 Q. Now, did June tell you that at the time that 18 she and Bill had this episode at their house in the 19 desert, that she had told him the sort of pent-up 20 thoughts that she was having about how she viewed 21 their marriage? 22 A. Well, I don't know that pent-up is accurate. I 23 think that she just thought that she wanted her to, 24 you know -- that they were both being honest and so 25 she told him how she felt. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 714 1 Q. And as she related it to you, how she felt was 2 that Bill had never really been there for her during 3 their marriage? 4 A. That's kind of -- kind of what he inferred, I 5 think. 6 Q. And this episode where June told Bill how she 7 was perceiving their marriage, she brought that up 8 with you more than once? 9 A. Yes. She said that he never let go of it. 10 Q. In fact, she told you that he never forgave her 11 for that; is that right? 12 A. Well, it bothered him. He kept bringing it up. 13 Q. Now, understanding I'm asking you about your 14 observations of June and Bill's marriage before they 15 came back to Maui in December of 1992, and the 16 question that I have for you is, as you observed it, 17 was it a happy marriage? 18 A. It was a troubled marriage. 19 Q. When June would share her private and her 20 intimate thoughts with you, did she also tell you 21 about, that she was going through a process of growing 22 as a person? 23 A. Yes. 24 Q. You and she discussed that a great deal, did 25 you not? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 715 1 A. Yes. 2 Q. In fact, June told you that she was in the 3 process of changing from maybe a more traditional wife 4 that always agreed with and let her husband decide 5 everything in the marriage, to a more independent or 6 self-assertive person; isn't that right? 7 A. No, I don't. I think what she was doing was 8 finding out what it meant who she was in Christ and 9 what that meant, and it was exciting to her and she 10 didn't feel that it was wrong, but it bothered Bill. 11 Q. It was a different role than she had played in 12 the marriage before that? 13 A. Yes, but she couldn't go back. You know, she 14 couldn't make a U-turn because she felt that the path 15 she was on was the right way. And she wanted him to 16 share it, but -- I don't know. 17 Q. As June talked with you and as you observed her 18 growing into her new role, there was some problem with 19 Bill about that? 20 A. Yeah. I think most non-Christians don't 21 understand Christians. He felt a little threatened, 22 maybe, by the way she was growing and he didn't 23 understand. 24 Q. And June told you that now that she had 25 discovered how she was growing and how she was PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 716 1 changing and it was the right path for her, that she 2 just couldn't go back to the old way; isn't that 3 right? 4 A. Well, that's not really a decision that you 5 could make to do that. I mean, it would be like going 6 back into darkness out of light. 7 Q. But June -- did June tell you that she herself 8 realized that she couldn't go back? 9 A. Yes. She couldn't be the wife that she was 10 when they were younger. She thought that perhaps 11 that's what he required of her. 12 Q. Now, in her quest to learn about her faith and 13 to grow in this way, did you know that June liked to 14 read Christian-oriented books and listen to 15 Christian-oriented tapes and that kind of thing? 16 A. Yes. 17 Q. In fact, you shared some of those things with 18 her? 19 A. Of course. 20 Q. Did June ever tell you what comments Bill made 21 about the Christian books and the Christian tapes and 22 that kind of thing? 23 A. There's a scripture that says, "The cross of 24 Christ is foolishness to those that are perishing," 25 and he thought it was foolishness. He didn't want the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 717 1 books and the tapes and things around because they 2 represented foolishness and the way she was changing 3 to him. She was full of love for him, but he didn't 4 perceive it that way. 5 Q. Did he, in fact, as she related it to you, tell 6 her that he wanted her to get all of those things out 7 of the house, that he was tired of looking at them? 8 A. No, just get them out of his sight. 9 Q. Were their times, Ms. Comstock, when you and 10 June were talking on the telephone when you could hear 11 Bill in the background? 12 A. Yes. 13 Q. And were their times that you heard him because 14 he was raising his voice at June? 15 A. He had a pretty big voice, so I don't know if 16 he was raising it, but sometimes he would tell her he 17 didn't want her to talk on the phone. I think, 18 perhaps, my closeness to her was an aggravation to him 19 sometimes. 20 Q. Up through the time that Bill and June came 21 back to Maui in December of '92, did Bill -- you may 22 have already implied this, but Bill didn't share 23 June's outlook about her spiritual life and did not 24 adopt the kind of Christian outlook and Christian 25 lifestyle that June had; isn't that right? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 718 1 A. I really don't know what he felt. He had gone 2 to church with her, but in January he accepted the 3 Lord, and after that, he started reading the books 4 that he complained about before. 5 Q. We heard testimony, Ms. Comstock, already about 6 Bill having a problem adjusting to his retired life on 7 Maui. Did June tell you about that? 8 A. Yes. 9 Q. What did she tell you about that? 10 A. Just one thing I remember is that he needed to 11 be busy. He was always accomplishing things and 12 giving to other people and stuff, and he'd offer to 13 help people, as I said before, at church with 14 financial advice or stuff like that. And he just 15 needed to feel busy, that he was still accomplishing 16 things. 17 Q. In fact, he had been a self-made man and built 18 up quite a successful business -- 19 A. Yes. 20 Q. -- before his retirement? 21 A. Yes. 22 Q. And did June also tell you that Bill really had 23 not found anything to do on Maui along the lines of 24 finding a feeling of accomplishment? 25 A. I don't remember any particular conversation, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 719 1 but that's the impression that I had, that we did 2 discuss that. 3 Q. Did you hear Bill talk about his former 4 business life? 5 A. Yes. 6 Q. And he was proud of it, wasn't he? 7 A. Yes. 8 Q. Did you hear Bill talk about the importance of 9 his working life to him? 10 A. No. I don't think I would characterize it as 11 the importance of it. He just told me little things 12 about the progress of it. Once he told me that the 13 way he made money was to be so busy, he didn't have 14 time to spend it. 15 Q. Ms. Comstock, again, during the private times 16 that you and June would share, and again, this is 17 before she -- they came back to Maui in December of 18 '92, did she share with you about whether, from her 19 perspective, her emotional needs had been met in the 20 marriage? 21 A. I'm sorry, her emotional needs had been met? 22 Q. Had been met in the marriage. Whether Bill had 23 met her emotional needs. 24 A. Are you speaking of after they came back? 25 Q. No, ma'am. Before they came back. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 720 1 THE COURT: What time are you asking of? 2 Q (By Mr. See) I was asking about the time, 3 say, during '92 before Bill and June came back to Maui 4 in December. 5 A. No, she didn't feel that he met her emotional 6 needs. 7 Q. Did June tell you a story about her having to 8 go to her mother's funeral? 9 A. Yes. She wished that Bill had offered to go 10 with her and be there for her, but he didn't, and it 11 kind of hurt her. 12 Q. So she had to go back to Illinois -- 13 A. Um-hum. 14 Q. -- by herself for her mother's funeral? 15 A. Yes. 16 Q. We've also heard some testimony about the 17 communication situation between Bill and June. Is 18 that something that you observed? 19 A. Well, I really don't know what you mean. I 20 observed them together many times, and sometimes there 21 was better communication than other times. 22 Q. All right. As you observed them as husband and 23 wife, isn't it the case that there were times when 24 they just didn't communicate with each other at all? 25 A. I don't really remember specifically. I know PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 721 1 that it wasn't great. It wasn't warm and friendly 2 before they got back from California. 3 Q. Did June talk with you about Bill being 4 unhappy, again before they came back to Maui in 5 December of '92? 6 A. You mean, when she called me from California? 7 Q. No. During the time that you observed their 8 marital life before they came back to Maui. 9 A. Well, sure. We talked about it. 10 Q. And did she tell you that Bill was unhappy? 11 A. I don't remember her saying that he was 12 unhappy. I just remember her recounting things that 13 happened that showed that he was unhappy or confused 14 or something. 15 Q. As you were able to observe Bill and June 16 interacting with one another, again during 1992, did 17 you learn either through observing or from June 18 telling you that there was anger in their marriage? 19 A. No. I don't really remember that. 20 MR. SEE: May I approach the witness, Your 21 Honor? 22 THE COURT: You may. 23 Q (By Mr. See) It's been now about seven or 24 eight years since these events took place? 25 A. Six years since they died. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 722 1 Q. Let me hand you a copy of the deposition. You 2 recall that we had a deposition over on Maui? 3 A. Yes. 4 Q. And we sat and we asked questions and you gave 5 answers? 6 A. Yes. 7 Q. If you wouldn't mind looking at Page 17. On 8 Page 17 at Line 9, I want to ask if you can recall you 9 were asked this question and gave this answer: 10 "QUESTION: Could I ask you this: As you were 11 able to observe Bill and June interacting with one 12 another in their marriage, did you learn that there 13 was anger in their marriage? 14 "ANSWER: Yes." 15 Do you recall telling us that, ma'am? 16 A. I don't recall telling you that, but I'm old 17 and I forget things. On Line 20, "June told me a lot 18 of things, I mean, resentments on both sides." I 19 think that is accurate. 20 Q. Mr. Vickery asked you about the first time that 21 Bill and June separated; that is, in the summer of 22 1991? 23 A. Um-hum. 24 Q. And what I'd like to ask you about that is, 25 from what you learned about the circumstances of that, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 723 1 based upon what June told you, was it your 2 understanding that Bill had left without telling June 3 he was going? 4 A. Yes. 5 Q. Did June tell you how that made her feel? 6 A. It was very hurtful. It was -- she didn't 7 understand it. It was confusing. 8 Q. Then if I could, ma'am, June and Bill, they 9 reconciled and they came back from Los Angeles and 10 they lived together again as husband and wife after 11 that separation? 12 A. He came back and they lived together. 13 Q. Then there was a second separation in the 14 summer of 1992? 15 A. Yes. 16 Q. And based upon what June told you about that, 17 was it the case that Bill had left again without 18 telling her? 19 A. Yes. I think he called her from the airport 20 and said he was going. 21 Q. Now, you've told us that you came to know the 22 family of Bill, Jr. who also lived on Maui -- 23 A. Yes. 24 Q. -- and you attended the same church for a time 25 as did Bill, Jr. and his family? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 724 1 A. Yes. 2 Q. Ms. Comstock, you had experience talking with 3 Bill, Jr. or having discussions with Bill, Jr. on 4 church matters or matters about which he had strong 5 beliefs? 6 A. Yes. 7 Q. And could you tell us please about Bill, Jr.'s 8 manner of speaking about matters about which he had 9 strong beliefs from your own observation. 10 A. We didn't agree on certain matters and he 11 thought that I was wrong and unforgiving, and I 12 thought that I had made it clear how I felt and we 13 just didn't agree. 14 Q. What I'm trying to ask you, ma'am, is the style 15 in which you have observed Bill, Jr. carry on 16 discussions, for example, about church related or 17 religious matters. 18 MR. VICKERY: Objection. Irrelevant. 19 THE COURT: Overruled. 20 Q (By Mr. See) And if I can, ma'am, let me ask 21 you this: Would you describe Bill, Jr.'s style in 22 discussing matters about church or about religion as 23 being tenacious? 24 A. He can be tenacious. So can I. 25 Q. Did you know or learn that Bill, Jr. had PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 725 1 conversations with his father about his father's 2 outlook and attitude towards religious beliefs? 3 A. Yes. 4 Q. Ms. Comstock, is it the case in discussions 5 about matters of religion and church activities that 6 Bill, Jr. and his style would simply not give up, 7 would press his point home and come back at it again 8 and again? Has that been an experience you've had? 9 A. I felt at the time that he was too tenacious. 10 I think we have both grown since then. 11 Q. Did you -- did June tell you about the fact 12 that Bill, Jr. had been having conversations with his 13 father about his father's religious orientation? 14 A. I think so, but I don't remember clearly. I've 15 tried to forget a lot of this. 16 Q. Now, we've heard testimony, ma'am, about the 17 fact that Bill, Sr. became depressed after he returned 18 to Maui in December of 1992, and I'd like to ask you a 19 couple of questions about that. 20 A. Well, I'd like to say I don't think he became 21 depressed when he returned. I think he was depressed 22 when he left. 23 Q. What I would like to ask you about is that time 24 period after their return in December of '92. You, 25 actually, in your interaction you saw that Bill, Sr. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 726 1 had difficulty functioning? 2 A. What do you mean by functioning? 3 Q. I mean, his depression seemed to affect his 4 ability to do ordinary things, day to day. 5 A. Well, when you're depressed, everything seems 6 kind of overwhelming, and it was hard for him, as it 7 is for anybody who is depressed, to do ordinary 8 things. 9 Q. And did June tell you that during her husband's 10 depression, that the lack of communication just 11 increased and he became angry and irritable? 12 A. I don't remember that. I remember her saying 13 that it concerned her that he didn't relate to the 14 grandchildren like he had before because they were his 15 joy. He just didn't take joy in anything, and it was 16 hard for him, overwhelming. 17 Q. Could I just refresh your recollection and ask 18 you to turn to Page 30 of your deposition? I want to 19 ask you about starting at Line 22, were you asked the 20 question and give this answer: 21 "Could you tell us what June told you about 22 Bill's depression, in other words, how was he acting, 23 how he seemed to her? 24 "ANSWER: He was harder to live with. He was 25 more and more removed emotionally and physically, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 727 1 just -- you know, he had his own little routine. He 2 would get in the car and go downtown, go to a place 3 for breakfast and wander around and stuff, but they 4 didn't do very much together, and that lack of 5 togetherness and lack of communication just increased 6 and he became angrier -- I'm sorry, he became angrier 7 and irritable, I guess." 8 Do you remember answering that way? 9 A. I remember her saying he didn't do his routine. 10 That he wasn't able to do that, and I don't know that 11 angrier is a word that I remember really. I think he 12 was irritable that he couldn't get over it, you know, 13 and that was -- when they first came back, I think 14 there was probably more communication and stuff, but 15 later he got harder to know how to help him, to know 16 how to deal with the depression. That was my 17 impression. 18 Q. Now, I think you said that after Bill and June 19 came back from Maui, you weren't really able to take 20 up your -- what had been your normal relationship with 21 your friend June; that is, you met one another and 22 went out for lunch and you met back and forth, that 23 that really wasn't possible? 24 A. Right. He didn't want her to go anyplace. If 25 she went to church, she was supposed to come right PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 728 1 home. We just weren't free to pal around like we used 2 to because he needed her. He didn't want her away 3 from him. 4 Q. And did June tell you that the reason that Bill 5 did not want her away from him during this time was 6 because he had become afraid to be home by himself? 7 A. She said he acted afraid. 8 Q. Did June also tell you that the times when he 9 acted afraid, he would actually go to bed in the 10 afternoon and pull the covers up to his nose and just 11 stay there? 12 A. Yes. 13 Q. So even though you could talk on the phone, it 14 was difficult to visit back and forth because of 15 Bill's condition? 16 A. Yeah. June just asked me to be patient and to 17 help her to make Bill her priority, that she was going 18 to help him through this and he had to come first and 19 we had to wait until he was better to hang out. 20 Q. Now, you did see your friends June and Bill 21 when you went over to their home for a Christmas 22 dinner in '92? 23 A. Um-hum. 24 Q. I'm sorry, you have to say -- 25 A. Yes. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 729 1 Q. How did Bill appear when you went over to their 2 home at Christmas of '92? 3 A. He was very quiet. He was not very 4 conversational. 5 Q. Was that a change from the Bill Forsyth that 6 you had known before? 7 A. Yes. 8 Q. Would you tell us what was the change? In 9 other words, how was he before? 10 A. He was kind of a character, kind of joking and 11 teasing and talking and interacting, and he just 12 seemed like he really wasn't there. 13 Q. And he actually got up from the dinner table 14 and went downstairs while you were all sitting there 15 eating dinner? 16 A. As I recall, we were all kind of eating dinner 17 and he said, yes, I'm sorry, I want to go downstairs 18 or something like that. 19 Q. And after he had gone downstairs, did June then 20 tell you that she was sorry, but he just was not able 21 to be social because he felt so bad? 22 A. I don't remember. 23 Q. Now, I'd like to ask you another question, if I 24 might. When June would tell you about the times when 25 Bill became afraid and would actually go and get into PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 730 1 bed and pull the covers up, did she tell you that when 2 he did that, he said, "I don't know what is happening 3 to me, but that I just feel strange"? 4 A. Yes. I think that that's accurate, but I don't 5 remember that she said that it happened more than 6 once, him pulling the covers up. I think I only 7 remember that as one occasion. 8 Q. But this was what June was relating to you 9 during the time period of December '92, January '93, 10 that general time frame? 11 A. Um-hum, yes. 12 Q. Bill, Jr. gave testimony about an occasion when 13 he and his father were driving to a swim meet. He 14 told you about that, too, didn't he? 15 A. Yes. 16 Q. And when Bill, Jr. related the story to you, 17 did he tell you that his father just said that he had 18 to go to the doctor, that he just felt like something 19 was happening to him and he couldn't handle it and he 20 needed to see the doctor? 21 A. Yes. 22 Q. And did Bill, Jr. also tell you about that 23 event that when they got to Dr. Roberts, the 24 psychiatrist's office, that the office was closed and 25 they were not able to see anyone? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 731 1 A. Yes. 2 Q. And did he also tell you that he told his 3 father at that time that his father did not need 4 medicine, that his father did not need doctors? 5 A. I don't -- the way you're putting it, I don't 6 think is accurate. I think he told him that because 7 the doctor wasn't there, that the great physician was 8 there and that they could pray and they did pray, and 9 Bill calmed down and got a peace about him. That he 10 was just -- 11 Q. I'm sorry, I wasn't trying to put it any way. 12 In fact, I hadn't really finished. I was going to ask 13 if Bill, Jr. told you that he was telling his father 14 at that time that he didn't need doctors, that he 15 didn't need medicine, but he needed to rely on his 16 relationship with the Lord and that after that, his 17 father seemed to calm down? 18 A. Well, I guess the way I remember it now, and it 19 has been a while, is that he said because the doctor 20 wasn't there, that, yes, we could pray and have access 21 to what Jesus says, that He is our peace. We don't 22 have to rely on pills and things. 23 Q. Just a couple more, ma'am. You told us that 24 the last time you saw Bill, Sr. was at a shower that 25 was held at their home? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 732 1 A. Yes. 2 Q. Can you tell us how Bill looked that day? 3 A. I remember that he looked thin and he looked 4 tired and he just didn't look like the regular Bill. 5 Q. And as the party was ending and you were 6 leaving, did you speak with him? 7 A. Yes. 8 Q. Can you tell us about that conversation? 9 A. He had been out during the shower and he had 10 come home and we were leaving and I hadn't seen him 11 for a while and I said something. I pat his chest and 12 said, "Honey, you're so skinny." And he said, yeah, 13 or something, and I said something about getting 14 better or something. I don't really remember now. 15 Q. Now, at this time in February and March of 1993 16 you were meeting at the Forsyths' home every Wednesday 17 for a fellowship for prayer? 18 A. Wednesday morning for prayer and Thursday night 19 for women's fellowship. 20 Q. Did you go to Bill and June's house the 21 Wednesday night of March the 4th, that is when they 22 were found? 23 A. I think that was a Thursday. 24 Q. Thursday night, sorry. 25 A. Thursday night, yes. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 733 1 Q. And when you got to their street, there were 2 police cars there; isn't that right, ma'am? 3 A. Yes. 4 Q. And before you knew what had happened, you 5 thought to yourself that Bill had killed himself; 6 isn't that right? 7 A. Yes. 8 MR. SEE: Ms. Comstock, I don't have any more 9 questions. I'm very, very sorry if this was 10 troubling. I thank you very much for coming. 11 MR. VICKERY: I just have a few. I'm sorry. 12 REDIRECT EXAMINATION 13 BY MR. VICKERY: 14 Q. I want to follow up on a couple of things that 15 Mr. See asked you. 16 First of all, whatever you and -- disagreement 17 that you and Billy had where you were tenacious and 18 you thought he was tenacious, did it have anything to 19 do with Bill or June or their relationship? 20 A. No. 21 Q. Okay. Secondly, Mr. See asked you or he 22 actually read a question and answer from your 23 deposition. I'd like to read the question and answer 24 right before it. Would you turn please to Page 16 of 25 that deposition? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 734 1 A. Um-hum. 2 Q. Here's the drill. This is real easy. I'll 3 read the question starting on Line 19, and if you'll 4 just read the answer you gave in the deposition. 5 "Did June tell you whether she and Bill had any 6 particular problem in communicating one with the 7 other?" 8 A. "Yes. They almost didn't, except I think you 9 get to the point where you try not to communicate when 10 you don't communicate, you know. She had her car and 11 he had his car and sometimes they met and sometimes 12 they didn't." You want me to go on? 13 Q. Yes, ma'am. Read the whole answer. 14 A. "They were like growing away from each other, I 15 think, before they went to California. After they 16 talked to Tom Brady, that was different. She was more 17 serene and more hopeful that it was possible to have a 18 life together. That they peeled off some of the onion 19 and that they had resolved some things." 20 Q. Ms. Comstock, from that forward after they were 21 with Dr. Brady and they peeled off some of the onion, 22 would it be fair to say that they had had a broken 23 relationship or bad marriage? 24 A. I don't think so, no. I think they were both 25 committed. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 735 1 Q. I want to ask you about an answer you gave 2 Mr. See where you said that in January, I believe I 3 wrote it down correctly, in January Bill accepted the 4 Lord and then started reading the books that he had 5 been complaining about? 6 A. Yes. 7 Q. Did you get that information from her or from 8 him? 9 A. I think I got it from the both of them. I 10 think June told me that she would often walk by a room 11 and would see him reading something and then we would 12 discuss things. They planned to go to Waimea to get 13 some training to be counselors with Youth With A 14 Mission, but they also have outreaches for old folks 15 like us and they wanted to do some ministry as a team. 16 And they would have made a formidable team. 17 Q. They wanted to both go together to some 18 Christian camp? 19 A. Yes. 20 Q. Was she the kind of person who twisted her 21 husband's arm into having his own religious beliefs? 22 A. No. She prayed for him for many years, but she 23 didn't twist his arm. 24 Q. Mr. See asked you about them arguing or 25 quarreling. Do you know any married people that don't PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 736 1 argue with their spouse from time to time? 2 A. No. 3 Q. Is your relationship with her or was your 4 relationship with her such that if their quarrels had 5 ever involved even a hint of physical violence, you 6 would have known about it? 7 A. I would have known about it. We both agreed 8 that that was unacceptable. If our husbands had ever 9 hit us or hurt us, that we would be out of there. 10 Q. And did she ever indicate to you that her 11 husband ever even threatened an act of violence to 12 her? 13 A. No. 14 MR. VICKERY: Thank you, ma'am. 15 MR. SEE: Nothing further, ma'am. Thank you 16 very much. 17 THE COURT: Thank you very much. Do we have 18 another witness we can cover in the next eight 19 minutes? 20 MR. VICKERY: No, Your Honor. I'm afraid I 21 don't. I don't have an eight-minute witness. I can 22 offer some exhibits if you want me to? 23 THE COURT: All right. Who is your next 24 witness? 25 MR. VICKERY: Dr. Healy. Your Honor, in light PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 737 1 of that, I was going to go ahead, in view of the 2 pretrial matters that we have discussed, and offer the 3 following liability exhibits, the plaintiffs 4 Exhibit 2, 4, 15, 16, 17, 18, 20, 21, 22, 33, 35, 45, 5 49, 53. 6 THE COURT: Wait. Slow down. 33, 35. 7 MR. VICKERY: Yes, 45, 49, 53, 58, 60, 67, 69, 8 71, 76, 78, 79, 97, 98, 103, 104, 106, 107, 109, 110, 9 111, 113, 116, 117, 118, 130, 143, 161, 162, 163, 164, 10 165, I believe has already been offered and admitted, 11 Your Honor, as has been 167 and 168. 170, 171, 172 12 has already been offered and admitted, and that would 13 conclude the offer at this time. 14 Those are not for limited purpose, but general 15 purpose pursuant to the Court's earlier rulings. 16 MR. SEE: If we could approach on that, Your 17 Honor? 18 THE COURT: Very well. Why don't we excuse the 19 jury at this time. Please be back at one o'clock. 20 (Whereupon, the following proceedings were had 21 in open court out of the presence of the jury.) 22 THE COURT: Mr. See. 23 MR. SEE: Your Honor, the point I wanted to 24 raise with the Court is this, I suspect that the 25 reason Mr. Vickery raises at this point is because PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 738 1 Dr. Healy is the next witness and I further suspect 2 that Mr. Vickery will want to ask Dr. Healy about 3 these liability exhibits, and my strenuous objection 4 is this, in his report, his expert witness report, 5 Dr. Healy raises no liability issue, none. In his 6 expert report. 7 THE COURT: No liability issue. 8 MR. SEE: His report is only about causation; 9 that is, whether Prozac causes the injuries complained 10 of in this case. He raises no liability issue; that 11 is, did Lilly perform appropriate studies? Did Lilly 12 provide appropriate information to either the agency 13 in Germany or the agency in the United States? 14 He puts nothing in his report with respect to 15 testifying about the adequacy of Lilly's package 16 insert. That is the key issue in the case, the 17 adequacy in the warning. There was nothing in his 18 report about any Lilly document, about any FDA 19 document, about the warning. He had a big packet of 20 documents which was Exhibit L to his deposition. And 21 he said, "Well, I got these after I prepared my 22 report. I've just looked at them in a cursory fashion 23 and I haven't relied on them for my report." 24 In his declaration, I think it's the one 25 recently filed -- PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 739 1 THE COURT: What was the document you were just 2 referring to? 3 MR. SEE: Exhibit L to his deposition. He had 4 a bunch of documents that he basically said I didn't 5 get these until after I wrote my report and hadn't 6 really looked at them. 7 So the plaintiffs have disclosed under Rule 26 8 nothing, no opinion by Dr. Healy other than does 9 Prozac cause suicide or homicide and does Prozac and 10 did Prozac cause it in this particular decedent or 11 decedents? 12 There was no disclosure. So I didn't ask any 13 questions about it. He did not disclose that he had 14 any opinion about whether Lilly had submitted the 15 right things to Germany or whether Lilly had submitted 16 the right things to the FDA or whether the warning or 17 insert was adequate. Absolutely nothing. 18 So under Rule 26 and under Rule 37, Dr. Healy 19 can't give opinions about those things because they 20 have not been disclosed, discovery hasn't been taken 21 about them. There's nothing about the FDA, nothing 22 about any liability issue in his report at all. 23 Nothing. 24 And what I suspect Mr. Vickery has in mind is 25 asking Dr. Healy to opine on every one of these PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 740 1 internal Lilly documents. When I deposed him and I 2 asked him what did you rely on, what are your 3 opinions, what are you going to testify about, there 4 was nothing about any of that. Nothing. And I have 5 relied on it up until the time I stand here. 6 Under Rule 37 he cannot give opinions about 7 these matters because they were not disclosed. 8 They're not in his report. Relying upon his report I 9 asked him no questions about it. About any of those 10 issues, was the warning adequate? Do you think we 11 should have said something different? Should we have 12 submitted the right information to the FDA? And so 13 on. I asked him nothing about that because nothing 14 was disclosed. 15 Under Rule 37 he's precluded. He can't give 16 testimony about these documents. I know that 17 Mr. Vickery wants to hand him the document and say, 18 look at that. Isn't that bad behavior? Didn't Lilly 19 do something wrong? Isn't that a bad study? And so 20 on. But he's an expert witness and he has an absolute 21 obligation to disclose his opinions and to disclose 22 what he's going to rely upon and none of this was 23 disclosed. None. His report contains not a single 24 mention of any opinion other than did Prozac cause 25 suicide in this man? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 741 1 There are cases that are right on this 2 question -- 3 THE COURT: Well, I guess my only question is, 4 why have you waited until this late hour to raise 5 this? 6 MR. SEE: With respect, Your Honor, I don't 7 think I have waited until the late hour. Dr. Healy 8 has said and disclosed nothing to indicate that he is 9 going to testify about Lilly documents, about what 10 Lilly had provided to the Germans, what Lilly provided 11 to the FDA. They hadn't told us that he's going to do 12 any of that. Never conducted discovery on it. Had 13 they told me, I would have done it, but I think I've 14 got a right to rely on his report. 15 Now, Dr. Shlensky, on the other hand, said I'm 16 going to give an opinion on the adequacy of the insert 17 and I -- therefore, I questioned him about that. I 18 got the discovery that I was entitled to. Dr. Healy 19 said nothing, offered no opinions on those topics. 20 And with respect, for an expert witness, as a 21 psychopharmacologist, as Dr. Healy is, look at 22 internal Lilly documents and say yes, I'm reading this 23 now and boy, this is bad behavior. Lilly didn't do 24 the right thing. No such opinion was ever disclosed, 25 never. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 742 1 Dr. Healy -- I think Dr. Healy, as the Court 2 has ruled, can testify about the scientific issue in 3 the case, whether Prozac is capable of causing suicide 4 and homicidality and whether Prozac caused it in this 5 particular man, but that's all. Because that's all he 6 disclosed. And I fear that the purpose of this mass 7 offer right now is to be able to say the document is 8 in evidence, so Dr. Healy can comment on it. 9 Well, with respect, lots of that is simply not 10 an appropriate subject for this expert witness. He is 11 a scientist and he disclosed testimony and opinions 12 about scientific causation issues. Not about 13 regulatory issues. Not about adequacy of barring 14 issues. Nothing about that. 15 THE COURT: Thank you. I'd like to see his 16 report then. 17 MR. SEE: Surely. I've got one here. 18 THE COURT: Mr. Vickery. 19 MR. VICKERY: Your Honor, I've never heard a 20 lawyer object to someone asking a witness about a 21 document in evidence and how all that might affect 22 their opinion. Did it corroborate, as many of these 23 documents do, the fact that Dr. Healy reached an 24 opinion from the scientific body of knowledge and his 25 own knowledge without considering internal Lilly PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 743 1 documents, doesn't mean that documents, which are 2 relevant, which the Court has determined to be 3 relevant, in spite of multifarious objections by Lilly 4 should not be -- you know, that the doctor can't be 5 questioned about those and how does this impact? 6 Well, it confirms it, corroborates it, so I -- I 7 frankly am at a loss because I've never heard a lawyer 8 say this document is in evidence, but you can't ask a 9 witness about it. If you can't ask the witness about 10 the documents in evidence, then we bind them up and 11 send them back to the jury room. 12 THE COURT: Well, you'll have to go by the 13 rules, Mr. Vickery. 14 MR. VICKERY: I understand I have to go by the 15 rules, Your Honor, but I don't know that I have 16 violated any rule at all. I don't believe that I 17 have. 18 THE COURT: Do you intend to ask Dr. Healy 19 about the adequacy of the notice or the actual cause 20 of the Forsyths death? 21 MR. VICKERY: He opined in his report and in 22 his declarations opined on the actual cause of the 23 Forsyths death. I don't remember, quite honestly, 24 whether either his report or his deposition or any of 25 the number of declarations that he has signed PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 744 1 addressed the issue of adequacy of the warnings. I 2 don't remember that issue. 3 THE COURT: So you weren't going to ask him 4 about that? 5 MR. VICKERY: I won't if there's a proper 6 objection. I really -- I probably had planned to ask 7 him what he thinks about these warnings and would that 8 have affected his opinion about the causation. I 9 mean, he has given an opinion. 10 THE COURT: It sounds like to me -- do we have 11 the report? 12 MR. SEE: Yes, sir. 13 THE COURT: It's twelve now. We'll break until 14 one o'clock and I'll make my ruling then. Did you 15 have some cases, too, on that, Mr. See? 16 MR. SEE: Yes, sir, one moment. 17 THE COURT: Might save my law clerk a few hours 18 over the lunch hour. 19 MR. SEE: And, Your Honor, I'm going to ask the 20 Court's guidance. I have a Ninth Circuit case, but 21 it's one where the Ninth Circuit says not appropriate 22 for publication. May not be cited. It talks right 23 about the issue. 24 THE COURT: Don't cite it, but I'll take a look 25 at it. And the two areas again that you're objecting PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 745 1 to, Mr. See? 2 MR. SEE: I'm objecting to Dr. Healy testifying 3 about any area except general causation; that is, 4 whether Prozac causes suicide or homicide in people 5 and specific causation, whether Prozac caused suicide 6 and homicide in Bill Forsyth. Those are the issues 7 upon which he made disclosure and he made disclosure 8 on no other issue. So I object to any other issue. 9 THE COURT: Thank you. And do we have the 10 cases now? 11 MR. VICKERY: Your Honor, did you want the 12 declarations, too, or just the report? 13 THE COURT: I think it's the report that 14 governs. We'll break until 1:00. Let's make it 1:15. 15 (Whereupon, a lunch recess was taken at 16 12:10 p.m.) 17 (The following proceedings were had out of the 18 presence of the jury.) 19 THE COURT: The Court has reviewed Dr. Healy's 20 report, as well as gone over the Rules 26 and 37 and 21 appropriate case law. This is an issue being raised 22 in the middle of trial. There's clear prejudice to 23 Lilly, and the Court's going to limit the testimony of 24 Dr. Healy to the opinions covered in Dr. Healy's 25 report. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 746 1 MR. VICKERY: Does that include his deposition 2 which supplement's his report, Your Honor? 3 THE COURT: No. What's in the report. That's 4 what the rules prescribe. 5 We'll take a short recess to allow the jury to 6 come in. 7 MR. SEE: Your Honor, I beg your pardon, could 8 I -- before the jury comes, there's a very small 9 matter. 10 The parties have invoked the rule that 11 witnesses should be excluded. 12 THE COURT: Correct. 13 MR. SEE: The Court did give leave to have 14 expert witnesses present during the testimony, as I 15 understood it, of fact witnesses. We're now going to 16 have the testimony of an expert witness, Dr. Healy. 17 The plaintiffs' other expert witness, Dr. Shlensky, is 18 sitting in the audience, and I would request that 19 Dr. Shlensky be excluded under the rule because 20 Dr. Healy has no fact testimony to offer that 21 Dr. Shlensky would, perhaps, want to see live for the 22 demeanor of the witness and so on. All Dr. Shlensky's 23 presence in the courtroom does is let him see me 24 cross-examine Dr. Healy, I think to my client's 25 prejudice. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 747 1 So I would ask that during the testimony of 2 Dr. Healy, Dr. Shlensky be asked to step out. There's 3 no justification for him to be in the courtroom during 4 that time. 5 THE COURT: Sounds fair enough. 6 (Whereupon, a recess was taken at 1:28 p.m.) 7 (Whereupon, the following proceedings were had 8 in open court in the presence of the jury.) 9 THE COURT: Please proceed, Mr. Vickery. 10 MR. VICKERY: Thank you, Your Honor. We call 11 Dr. David Healy. 12 THE CLERK: Please raise your right hand. 13 DAVID HEALY, M.D. Ph.D., 14 called as a witness on behalf of the Plaintiffs, after 15 having been first duly sworn to tell the truth, the 16 whole truth, and nothing but the truth, was examined 17 and testified as follows: 18 THE CLERK: Please be seated. Please state 19 your name and spell your last name. 20 THE WITNESS: My name is David Healy, 21 H-E-A-L-Y. 22 DIRECT EXAMINATION 23 BY MR. VICKERY: 24 Q. And I said doctor when I called you. Are you, 25 indeed, a doctor, sir? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 748 1 A. Yes, I am, Mr. Vickery. 2 Q. What kind of doctorate do you hold? 3 A. In this country, I would qualify as an M.D., 4 Ph.D. I have both a medical degree and a 5 post-doctoral research degree. 6 Q. When did you get the degree that you hold and 7 from what institution? 8 A. The primary medical degree that I got was in 9 1979 from the National University of Ireland. The 10 doctoral research, the Ph.D. thesis, was from, once 11 again, the National University of Ireland in 1985. 12 Q. Are you Irish, sir? 13 A. I am, indeed. 14 Q. Did you grow up and were you educated in 15 Ireland? 16 A. I did. 17 Q. Where do you currently reside? 18 A. I reside at the moment in the United Kingdom. 19 After training in Ireland and after obtaining my 20 Ph.D., I then moved to the University of Cambridge 21 where I spent between four and five years before 22 moving to Wales where I now work. 23 Q. What is your title at the university you are 24 affiliated with in Wales? 25 A. In the University of Wales, we have a division PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 749 1 of psychological medicine. This is a department of 2 psychiatry and it has both North Wales and South Wales 3 branches to it, and I'm the director of the North 4 Wales Department. 5 Q. Dr. Healy, when you mentioned a research paper, 6 do you do, in essence, a dissertation? 7 A. Yes. 8 Q. And can you tell us what was the subject of 9 your dissertation for the Ph.D. equivalent degree? 10 A. The work that I did was on what was called 11 radio-labeled binding. What we became able to do 12 during the late 1970s was to radio label some of the 13 drugs that are used to treat mental illnesses and 14 other illnesses, and using radio labels, like this, we 15 were able to look at things like serotonin reuptake 16 for the first time into nerve cells in the brain, and 17 into platelets in the bloodstream of people who were 18 depressed, for instance. My work centered primarily 19 on serotonin reuptake. This is before Prozac had 20 actually hit the market. 21 Q. Let us write down those two words, serotonin 22 and reuptake. After we get through the qualification 23 issue, I'll ask you about those. 24 When you got your degrees, is there some kind 25 of specialty training you get in psychiatry after your PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 750 1 general medical degree? 2 A. Yes, there is. It usually takes the better 3 part of seven or eight years. 4 Q. What specialty did you pursue? 5 A. I pursued the field of general psychiatry with 6 a -- my Ph.D. work was in psychopharmacology, so I 7 would be both a psychopharmacologist and a general 8 psychiatrist. 9 Q. Okay, sir. Now, have you, over the years, 10 authored scientific papers that have been published in 11 peer-reviewed journals? 12 A. Yes, I have. 13 Q. And would you just explain for the jury what it 14 means when we talk about publishing something in a 15 peer review journal? What is that process? 16 A. What that briefly means is that as a younger 17 person or as an individual out in the street, you may 18 get a very good idea. You may even get a bright idea. 19 But if you write the article up and want to get it 20 published in one of the journals that are really 21 influential, you've got to go through a process called 22 peer-review. 23 And what would happen is one of, say, the 24 members of the jury or yourself, Mr. Vickery, might 25 submit an article to one of the journals in this area PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 751 1 of psychopharmacology. The idea could be good, but 2 you'd be faced with someone like me looking at just 3 the methods that you've used, whether you've used 4 generally accepted methods, whether your conclusions 5 are reasonable conclusions to come to, and it's only 6 if two or three like me looked at your work and 7 thought that this was reasonable to be published, that 8 it would then get published. 9 Most peer-review journals pride themselves on 10 turning down more than 50 percent of the articles that 11 are submitted to them. 12 Q. And how many journals -- articles have you 13 published in peer-review journals? 14 A. Over one hundred. 15 Q. A hundred? 16 A. Um-hum. Yes. 17 Q. Do any of those deal with any of the subjects 18 that we're here to talk about today? 19 A. Yes, they do. There have been two reviews of 20 the issue, in particular, looking at how you would 21 work out whether a drug like Prozac could cause people 22 to become violent and suicidal, and there have also 23 been a series of case studies that we have done on 24 individuals who have appeared to become suicidal on 25 Prozac. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 752 1 Q. So how many articles altogether have you 2 authored dealing with this issue of Prozac causing 3 violence or suicide? 4 A. That have been peer-reviewed, three. 5 Q. Okay, sir. Have you, in addition to your 6 published articles in the scientific journals, 7 published books? 8 A. I have. At this stage, there are nine books 9 that have been published and there are three more that 10 are being worked on. 11 Q. And are any of the books that you have 12 published pertinent to the issues that we are here to 13 discuss today? 14 A. They are. Several books, I think, are 15 pertinent. I have written on the history of the 16 antidepressants, and that's clearly highly pertinent. 17 I've also interviewed pretty well all of the senior 18 figures in the field, and in the course of my 19 interviews with these people, either the basic 20 scientists working in the lab on how these drugs work, 21 or the marketing people with pharmaceutical companies 22 or the clinicians who've used the drugs, I've, on 23 quite a few instances, asked the question about 24 akathisia and the question about whether a drug like 25 Prozac can cause it. So I've consulted with the most PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 753 1 senior figures in the field on this issue. 2 I also have a book for lay people on 3 psychiatric drugs, which goes into, just this issue, 4 and how antidepressants can make a person who's 5 depressed worse. 6 Q. Okay. The books or -- the book or books of 7 interviews with the senior people in the field, are 8 either or both of those volumes in print already? 9 A. Well, the Harvard book on the history of the 10 antidepressants has sold out. I understand they're 11 going to have a paperback version of it. They may go 12 to a further hardback run before the paperback 13 version. 14 Q. Is that this book right here, "The 15 Antidepressant Era"? 16 A. That's that book right there, yes. 17 Q. And did you say the Harvard Press published it? 18 A. Harvard University Press published it. 19 Q. In what year? 20 A. It was published -- well, it came out the start 21 of 1998. 22 Q. And, Dr. Healy, is it typical when someone 23 publishes things, as you do, to have feedback from 24 other scientists, either book reviews or letters to 25 the editor, when you submit journal articles? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 754 1 A. Well, there are two things that will happen. 2 Before a group like Harvard would be happy to have the 3 book published, they will also have it peer reviewed. 4 So this book was peer reviewed. They sent this out 5 for vigorous comment before they're actually prepared 6 to say yes, we'll have it. 7 Since it's come out, the book has been reviewed 8 in journals like Nature, Science, The New England 9 Journal of Medicine, the Journal of the American 10 Medical Association, and a range of other journals. 11 Q. Have any of the reviews of your book been 12 critical of your book or methodology? 13 A. None to date. 14 Q. What's the best one you got? 15 A. Well, the one that appeals to me was from 16 the -- 17 MR. SEE: I object to hearsay. 18 THE COURT: Huh? 19 MR. SEE: I object to the hearsay. 20 THE COURT: Sustained. 21 Q (By Mr. Vickery) Dr. Healy, have you been 22 asked from time to time to lecture, either in your own 23 country, this country, or other countries, on the 24 topics that are germane to your testimony today? 25 A. I have. I've lectured on issues that are PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 755 1 highly germane to the issues today in a variety of 2 settings in Europe, in Japan, in the United Kingdom, 3 and I've included some of the issues that I'm going to 4 include in the course of the afternoon in lectures 5 here in the United States as well. 6 Q. Now, all total, how many different scientists 7 have you lectured to and shared with them the opinions 8 that you're here to give and the methodology you used 9 to arrive at it? 10 A. Quite apart from the peer-reviewed articles 11 that I have no way of knowing how many people have 12 read these, but they seem to be fairly highly cited at 13 this stage, in audiences to whom I've talked, the 14 audiences have varied in size between 20 to 30 people 15 up to 3 to 400 people. I would estimate, all total, 16 over 1,000 people, at least, have heard me talk on 17 these issues. 18 Q. And when you have talked to that 1,000 19 different scientists about it, have you ever had 20 repercussions from them? Anyone been critical that 21 this is bad science, or anything of that ilk at all? 22 A. No, I haven't. One thing that may be worth 23 mentioning is after a talk that I gave in the United 24 Kingdom recently, some of the representatives from 25 Lilly who were there -- PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 756 1 MR. SEE: Objection to hearsay, Your Honor. 2 THE WITNESS: This is not hearsay. This is a 3 statement of fact. 4 MR. VICKERY: Your Honor, a statement by a 5 Lilly person would not be hearsay. 6 THE COURT: I'll overrule the objection. 7 THE WITNESS: Came to me and said they were 8 unhappy with what I was saying, and I offered to them, 9 at that point, to debate the issues on any forum of 10 their choosing with any of their experts in any 11 country that they wished. This has been my position 12 throughout. 13 Q (By Mr. Vickery) And has Lilly ever taken you 14 up on that offer? 15 A. No. 16 Q. Now, have you been invited to speak before 17 scientific associations in the future? I mean, are 18 there some future things coming up? 19 A. Yes, there are. One of the more important ones 20 is, I've been asked to give a lecture called the Roth 21 Stieger lecture in Zurich this year. This is a 22 distinguished annual lecture. I've only just come 23 last week from talking about the history of the 24 antidepressants to the American Psychopathological 25 Association. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 757 1 Q. Say that one again a little bit slower. 2 A. Sorry. I'm very sorry. The -- it's the APPA, 3 it's called, which stands for the American 4 Psychopathological Association. This is a very select 5 group of scientists who usually meet in New York. 6 Q. And you were a speaker last week at that? 7 A. I was. 8 Q. Now, what's this Zurich deal that's coming up 9 this year? 10 A. This is a distinguished guest lecture. It's a 11 lecture that is put on by the Department of 12 Pharmacology in the University of Zurich once a year 13 where they have funds to bring a lecture of their 14 choosing to talk on some issue of broad relevance to 15 health. 16 Q. Have you chosen your topic for the 17 distinguished lecture this year in Zurich? 18 A. I have chosen to talk about the origins of the 19 antidepressants and how it has seemed, although we 20 appear to have drugs that supposedly should help the 21 illness, more and more people seem to be depressed 22 these days than ever were depressed when the 23 antidepressants were first discovered. This raises a 24 broad range of issues of social and human importance 25 which I would hope to address. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 758 1 Q. Now, do you belong to any professional 2 associations that guys like you belong to? 3 A. Yes, I do. I belong to the British Medical 4 Association. I belong to the Royal College of 5 Psychiatrists. I belong to the European College of 6 Neuropsychopharmacology. I belong to the Association 7 of European Psychiatrists. I belong to the British 8 Association for Psychopharmacology, for which I was 9 the secretary for a number of years. 10 I'm sure there are more organizations, but I 11 can't think of them off hand. 12 MR. VICKERY: Your Honor, at this time I tender 13 Dr. David Healy as an expert in the fields of 14 psychiatry and neuropsychopharmacology. 15 THE COURT: Mr. See. 16 MR. SEE: Your Honor, I have no objection to 17 Dr. Healy's qualifications. 18 THE COURT: The Court finds Dr. Healy qualified 19 as an expert to testify in the area of psychiatry and 20 neuropsychopharmacology. 21 MR. VICKERY: Thank you, Your Honor. 22 Q. Dr. Healy, I'd like to get to the core opinions 23 and then we'll come back and discuss the foundation 24 for those opinions, if we may. 25 Do you have an opinion, based on reasonable PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 759 1 medical or scientific certainty, as to whether Prozac 2 can cause some people to become violent or suicidal? 3 MR. SEE: Objection, Your Honor, on a 4 foundation ground and ask to approach. 5 THE COURT: All right. 6 (Whereupon, the following proceedings were had 7 at side bar out of the hearing of the jury.) 8 THE COURT: The question is Prozac can cause -- 9 MR. VICKERY: Some people to become violent or 10 suicidal. 11 THE COURT: Mr. See. 12 MR. SEE: My objection is there is no 13 foundation, in that Dr. Healy's testified at the 14 Daubert hearing that the reasons that Prozac does 15 this, in his view, is by causing people to become 16 akathisic; that is, have akathisia. There is no 17 factual basis in this case that akathisia was present, 18 therefore, there's no foundation for him to give the 19 opinion. 20 THE COURT: I thought his opinion was going to 21 be that Prozac causes akathisia, which in turns causes 22 violence. 23 MR. VICKERY: It does, Your Honor. That will 24 be further explained. I'm trying to set the broad 25 stage for it. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 760 1 THE COURT: Ask for only that opinion. 2 MR. VICKERY: Okay. I'll do that. 3 (Whereupon, the following proceedings were had 4 in open court in the presence of the jury.) 5 Q (By Mr. Vickery) Dr. Healy, do you have an 6 opinion, based on reasonable medical and scientific 7 certainty, as to whether Prozac causes some people to 8 have a condition called akathisia? 9 A. Yes, I do. 10 Q. And what is that opinion? 11 A. I believe that Prozac can cause some people to 12 have akathisia. 13 Q. And do you have an opinion, based on reasonable 14 medical and scientific certainty as to whether this 15 Prozac-induced akathisia causes some people to become 16 violent or suicidal? 17 A. Yes, I do. 18 Q. And what is that? 19 MR. SEE: I beg your pardon. Objection, 20 foundation, Your Honor. 21 THE COURT: Overruled. 22 Q (By Mr. Vickery) What is that opinion, sir? 23 A. That, yes, this Prozac-induced akathisia can 24 lead to suicide and violence. 25 Q. Do you have an opinion, based on reasonable PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 761 1 medical and scientific certainty, as to whether Bill 2 Forsyth -- let me restate it this way: Whether Prozac 3 was a substantial factor that caused Bill Forsyth to 4 become akathisic, if I've said that word correctly, 5 and then violent and suicidal? 6 MR. SEE: Objection, Your Honor, foundation. 7 No factual predicate. 8 THE COURT: What? 9 MR. SEE: No factual predicate. 10 THE COURT: This is his opinion at this time. 11 You'll have to back that up with factual analysis. Go 12 ahead. 13 Q (By Mr. Vickery) And what is that opinion, 14 sir? 15 A. Yes. I have the opinion that Mr. Forsyth 16 became akathisic on Prozac and this led directly to 17 his death and the death of his wife. 18 Q. And is it your opinion that his akathisia was 19 caused by the Prozac that he took? 20 A. Yes, it is. 21 Q. Now, let's back up then and discuss some of the 22 foundation for these, and if we can take you all the 23 way back to your school days, tell us about serotonin 24 and reuptake. What is serotonin first? 25 A. Could I quickly come out and draw this on the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 762 1 board for the Court? I think I can be helpful by 2 doing this. 3 MR. VICKERY: Is that permissible, Your Honor? 4 May he do that? 5 THE COURT: That's permissible. 6 THE WITNESS: Do I need to wear a mic or will 7 the jury be able to hear me? 8 All right. I think one of the -- 9 MR. SEE: Your Honor, my only request would be 10 that we proceed by question and answer. 11 MR. VICKERY: I'll be glad to ask a question. 12 THE COURT: Overruled. 13 Q (By Mr. Vickery) Please proceed. 14 A. One of my concerns here is that the Court, Your 15 Honor, the jury, and the lawyers here are going to be 16 faced with a lot of scientific evidence, and this can 17 bamboozle people. In essence, I believe that the 18 scientific issues in this case are extremely simple, 19 and I hope to illustrate this point. 20 Serotonin is one of the neurotransmitters in 21 the brain. It is only one of many neurotransmitters 22 that are in the brain. What's a neurotransmitter? 23 Well, you can have two nerve cells. You can have one 24 here and you can have one here. In some way, they've 25 got to talk to each other. These nerve cells liberate PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 763 1 neurotransmitters which go from this one, nerve cell A 2 to nerve cell B. And the idea is this is how nerve 3 cell A talks to nerve cell B. Let's assume that nerve 4 cell A is a serotonin nerve cell. What it's going to 5 release is serotonin. I'll put an S here. 6 Q. Would it help to put it in blue? 7 A. Yes, it would. Now, what we found out many, 8 many years ago were that there were two forms of 9 antidepressants. There were a group of drugs called 10 the MAOIs, the monoamine oxidase inhibitors, and we 11 knew from very early on that they increased the 12 concentration of the number of neurotransmitters in 13 the brain of people who were depressed or in any 14 healthy volunteers who had these drugs. 15 We had another group of drugs which were the 16 tricyclic antidepressants from which Prozac has been 17 derived. And one of the things we found out -- we 18 didn't find this out awfully early, but one of the 19 things we found out was serotonin and other 20 neurotransmitters get released from nerve cell A. It 21 was very important that the nerve cell takes these 22 back up again because if not, they get broken down and 23 you end up with less serotonin. 24 Q. Let me stop you right there. Is that like a 25 recycling process? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 764 1 A. Yes. 2 Q. Is that a way for us to think of it? 3 A. Yes, it is a recycling process. We call this 4 the reuptake mechanism. 5 Q. Now, let me see if I can clarify with a 6 question. If nerve cell A wants to send a message to 7 nerve cell B, it gives that message to this little 8 serotonin molecule, kind of a carrier pigeon or 9 something? 10 A. Yes, in essence. 11 Q. And it goes down and delivers the message to B 12 and then does it go back to A to get the next message? 13 MR. SEE: Your Honor, objection to the 14 testimony by Mr. Vickery, and again, I ask that the 15 narration be stopped, that we proceed by question and 16 answer. 17 THE WITNESS: I think it is very important, 18 Your Honor, to bring the point out. 19 THE COURT: Well, Mr. Vickery can ask the 20 question and you may answer. 21 THE WITNESS: All right. 22 Q (By Mr. Vickery) All right. Here's the 23 question, when nerve cell A sends the message to B, 24 then does the serotonin molecule get recycled back 25 into nerve cell A? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 765 1 A. It does. 2 Q. And can you explain for us the process by which 3 it is recycled? 4 A. Yes. There is a reuptake mechanism which takes 5 it back from this area here (indicating) back into the 6 nerve cell. Now, what we found was drugs like some of 7 the early antidepressants, and now, drugs like Prozac, 8 block this, so the serotonin is not going to go back 9 into nerve cell A. It's going to remain here 10 (indicating). 11 And the simple view we have -- you just aren't 12 going to believe how simplistic this view was -- the 13 idea was that maybe some of these neurotransmitters 14 are low in the people who are depressed. Not only 15 serotonin -- because in the early days we didn't think 16 it was important at all, and there's an awful lot of 17 people who still don't think it's of any importance at 18 all, but what the idea was is that we would increase 19 the amount of serotonin here (indicating) to act on B, 20 and that's what many people like me had thought, 21 medical students and the kinds of lectures that we 22 would have given for ages and ages and ages. 23 Until one day, what happened to me, which was 24 interesting, was that I was having to give this kind 25 of a talk to a group of lay people, medical students PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 766 1 and lay people, and one of the people in the audience 2 said to me, "Look, if taking the serotonin back up 3 into nerve cell A is all that important in order to 4 make sure that it's not broken down, if you don't take 5 it back up, if you block the reuptake of this thing, 6 you've got to leave it here and it's going to be 7 broken down and you're going to end up with less 8 serotonin in your brain; isn't that right?" 9 Okay. This is an obvious view from a lay 10 person who says, look, this emperor looks to me like 11 he's got no clothes on. And the answer is, they're 12 right. We don't know what drugs like Prozac do to the 13 overall levels of serotonin in your brain. You will 14 see a lot of hype, a lot of marketing from a lot of 15 different companies -- 16 MR. SEE: Your Honor, I object. I'm sorry, 17 Dr. Healy. I object to about the last two statements 18 of Dr. Healy and ask that they be stricken. They're 19 irrelevant. And I also move to strike Dr. Healy's 20 statement about what he doesn't know as speculation. 21 THE COURT: Overruled. You may cross-examine 22 him. 23 Q (By Mr. Vickery) Dr. Healy let me ask you a 24 question. 25 A. Can I -- PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 767 1 Q. Let me explain something to you, okay. You've 2 never testified in any court anywhere, have you? 3 A. No. 4 Q. Okay. Let's set the ground rules, okay, so we 5 won't get into trouble. When Mr. See makes an 6 objection, we need to wait for the judge, okay? 7 A. Okay. 8 Q. And I'm the one that's got to handle that. You 9 can't do that. 10 Let me ask you this: The Prozac, does it 11 operate in some way to block the reuptake site of the 12 serotonin? 13 A. It does. 14 Q. And let me ask you this: Is there anyone 15 anywhere in the world today that can tell us how much 16 serotonin in this space between A and B is appropriate 17 to anyone? I mean, could you tell me how much I 18 should have in that space in my brain? 19 A. No, I can't. We have no evidence that there's 20 any lowered serotonin in the brains in anyone who's 21 not depressed. In fact, all the evidence that we have 22 is that the serotonin in the brains of people who are 23 depressed is lowered. 24 Not only -- let me illustrate this to you. We 25 have drugs, which are antidepressants, which get rid PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 768 1 of the serotonin in your nerve cell completely. We 2 also have drugs, which are antidepressants, which 3 increases the rate by which the serotonin goes back in 4 the nerve cell. 5 Q. Let me stop you and ask you a question. You 6 mean there are drugs in use as antidepressants, one of 7 which blocks the reuptake and gives us more serotonin 8 here? Right? 9 A. Yes. 10 Q. And is that a drug like Prozac? 11 A. It is. 12 Q. Let me see if you taught me anything. Is this 13 little space here between A and B called the 14 presynaptic cleft? 15 A. It's called the synaptic cleft, yes. 16 Q. And then number two, there are other drugs that 17 decrease the amount of the serotonin in this space? 18 A. That's right. 19 Q. Less serotonin. And then what was the third 20 one? 21 A. Well, there are two groups of drugs which do 22 this, which reduce the serotonin levels in two 23 different ways. 24 Q. Okay. 25 A. The point I'm moving on to making is that the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 769 1 levels of serotonin, per se, are not important when 2 you're trying to treat a person who's depressed. They 3 may be important in terms of the side effects you 4 cause. 5 The issue is what does a drug like Prozac do to 6 get a person who's depressed well if it's not 7 increasing the serotonin here? I will put to you that 8 the action of Prozac, to get people who are depressed 9 well, is to reduce your emotional reactivity to the 10 environment. For some people this will feel extremely 11 good. You will feel better than well on this, and 12 other people, when this happens to you, will feel 13 emotionally blunted. 14 If I took the jury here and halved them down 15 the middle -- 16 Q. We can't do it to the jury. How about if we 17 half the folks out here. 18 A. If we took half the court here and put them all 19 on Prozac, half of them would say, gosh, I'm reacting 20 less to the environment. In fact, the shoes at the 21 end of the stairs out of order, that's not bugging me 22 as much as it used to bug me before. That kind of a 23 thing. Lately when I go to meet my boss, usually I'm 24 awfully nervous and anxious and that's not happening 25 quite as much. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 770 1 The other half of the audience wants to be in 2 touch with the environment more will say, this is 3 awful. I feel emotionally blunted on this drug. This 4 is not a side effect of the drug. This is what it 5 does. This is the central action of the drug. 6 Q. This is the way it works? 7 A. This is what it does. 8 Q. Let me ask you to take your seat back on the 9 stand, if I may. 10 So you mean no one in the world knows what, 11 quote, balance is, what the chemical balance in the 12 brain is? 13 A. Absolutely not. No one knows at all. 14 Q. Was there a point in time, and the jury has 15 heard something about this, only in my opening 16 statement, at which scientists said maybe if we 17 increase the serotonin, then that will treat 18 depression because we found out that some people who 19 are suicidal, after they're dead and we measure in 20 their synaptic cleft, had low serotonin? Was that a 21 scientific basis on which the drug Prozac and others 22 were developed and marketed? 23 A. No, this is not the basis in which Prozac was 24 actually developed, but yes, you're right. There was 25 a point where people thought that there was lowered PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 771 1 5-HT -- serotonin. We call it 5-HT over in Europe. 2 So if by accident, every so often I call it 5-HT, 3 you'll know what's happening. 4 There was lowered serotonin in the brain of 5 people who are suicidal. Now, I've just explained to 6 you, however, that all the evidence that has been done 7 on animal works given Prozac chronically, is that it 8 lowers the serotonin level in the brains of those 9 animals. 10 Q. Okay, sir. Now, does a drug -- does Prozac 11 affect the levels of serotonin in the synaptic cleft 12 of people's brain? 13 A. Prozac does affect the level of serotonin in 14 the synaptic cleft of people's brains making more 15 serotonin available to interact with receptors; 16 serotonin one, serotonin two, and serotonin three, for 17 example. 18 Q. Is serotonin just confined to the brain or do 19 we have it all over our bodies? 20 A. We have it all over our body, in our gut, in 21 our blood, et cetera, and if you look at the blood 22 levels of people who take a drug like Prozac, for 23 instance, their serotonin levels are reduced by this 24 drug. 25 Q. Okay. Now, when serotonin operates in the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 772 1 brain and it changes the brain -- this brain -- I'm 2 sorry, Prozac it changes this brain chemistry, does it 3 affect a person physically or behaviorally, the way 4 they behave, or both? 5 A. It affects you almost immediately in a variety 6 of ways that could be called physical, in the sense 7 you'll feel nauseated, most likely, very early on, but 8 also in a range of behavior ways. As I said to you, 9 intrinsic to the action of this drug, the drug cannot 10 act if it's not in some way making you behaviorally 11 insensitive to the environment. So I guess this is 12 what you would call a behavioral effect, and that 13 action is there within hours or days that they're on 14 the drug. 15 Q. Within hours or days it has that affect on a 16 person? 17 A. That's right. 18 Q. Now, we're going to be talking about another 19 term that I would like for you to define for us now 20 and that term is -- do you pronounce it akathisia or 21 akathisia? 22 A. Akathisia, akathisia. Probably both. It is a 23 bit like either either, you know. 24 Q. I'll just choose one. We have heard a lot -- 25 somewhere around this courtroom there's a big board PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 773 1 that Mr. See wrote on during his opening statement -- 2 about akathisia having to have two components; a 3 subjective component, the way I feel, and an objective 4 component, the way I act. 5 Is that true for akathisia that's caused by 6 Prozac? 7 A. No, that's not true. And I'd like to 8 illustrate this point with some lecture notes that I 9 use when I lecture on this issue, if I may. 10 Q. Okay. Well, let me see. Let me show them to 11 counsel. We'll come back to that at another time, 12 okay. 13 Is akathisia -- let me ask you this: Is 14 akathisia, that is caused by Prozac, a subjective 15 phenomenon? 16 A. Akathisia that's caused by any drug pretty 17 well, except in rare cases, is a subjective 18 phenomenon. The ways in which it was actually 19 described, first of all, is almost exclusively 20 subjective. May I quickly outline to you the history 21 of it without using any side quotes? 22 Q. Sure. Can you give us just the history of this 23 phenomenon, akathisia, and explain to us how it 24 developed? 25 A. Right. And this is where the medical PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 774 1 profession has been very unhelpful to all of you in 2 the court because we've used this strange word, which 3 I hope to help you over to some extent. 4 The word got used first in the court of Louis 5 Napoleon in 1860 where Louis Napoleon, the Emperor of 6 France, had a courtier who couldn't sit still. Now, 7 in court this is not a good idea. You've got to be 8 able to sit still when the emperor is there, and this 9 unfortunate man couldn't. And the syndrome was 10 described first in connection with this man. It was 11 discovered by a man called Truseau. 12 No one heard anything more about akathisia 13 until after the big flu epidemic just after World War 14 I which caused encephalitis lethargica, which left an 15 awful lot of people -- 16 Q. Woe. Woe. Stop. That was two big ten-penny 17 medical words. Can you just tell us what that means? 18 A. After the big -- well, in 1918, I'm sure an 19 awful lot of you here will know, that there was the 20 most serious epidemic of influenza that we have ever 21 had in the world, and an awful lot of people were 22 killed. More people were killed by it than were 23 killed by World War I itself. And an awful lot of 24 other people were left with permanent neurological 25 problems in the hospital. And for any of you who have PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 775 1 seen the movie "Awakenings" by Oliver Sacks, from his 2 book, where you saw these people who were 3 parkinsonian, being woken up by some of the new drugs 4 we had during the 1960s, these were people who had 5 that condition. 6 There were a number of other people who had the 7 condition who weren't frozen and couldn't move for 8 years and years. They had the opposite problem. They 9 couldn't stop moving. They were restless, and the 10 word akathisia was used for those as well. Now -- 11 Q. Has it been used for all of these things? 12 A. The point I'm actually trying to make to you is 13 it was very, very rarely used for almost one hundred 14 years. There were only these two episodes, these two 15 groups of people for whom it was used. It next came 16 into use in the context of the first antidepressant 17 that was introduced into psychiatry by a randomized 18 control trial, and this is a drug called Reserpine. 19 It's one of these drugs that lowered 5-HT in the 20 brains of people who are depressed or anxious or 21 whatever. 22 Q. Lowered serotonin? 23 A. Serotonin. Sorry, Mr. Vickery. This was a 24 drug in the 1950s that caused reports, where people 25 said they felt better than well on this drug. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 776 1 Psychiatrists advised other psychiatrists you should 2 stop doing psychotherapy. This drug is good 3 psychotherapy in pill form. Exactly the kind of 4 quotes that you have heard about Prozac in Peter 5 Kramer's book, "Listening to Prozac," were all made 6 about Reserpine in 1954, 1955. 7 Now, Reserpine caused people to commit suicide. 8 This is a drug proven to be an antidepressant in 9 controlled clinical trials. It was a drug that left 10 some people feeling better than well. It was a drug 11 that led other people to commit suicide, and they 12 committed suicide, when you read the reports, because 13 they became akathisia. 14 Now, the point, the crucial point here you have 15 to bear in mind, is if you read the reports, which I'm 16 held up from actually showing you at the moment, the 17 few brief quotes, most of the quotes that what was 18 happening to these people at the time were -- they 19 report things like the patient felt nervous, afraid, 20 anxious. The patient saying, I'm afraid of some of 21 the unusual impulses that I seem to have developed on 22 this drug. I'm afraid of what I might do since I've 23 been on this drug, in one or two, but in a minority of 24 cases, you had reports of the patient being visibly 25 restless. Their legs moving. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 777 1 For the most part, the restlessness that was 2 described by the patient was only understood by the 3 psychiatrists because it was described to them by the 4 patients. 5 Q. You mean the psychiatrists didn't see it? 6 A. No. There's a real problem here, Mr. Vickery, 7 you see, which is this, that often when you've got a 8 person who's taking Prozac, for instance, for the 9 first time or Reserpine or one of these other drugs 10 that can cause akathisia, which is you haven't seen 11 this person when they're well. You've only maybe seen 12 them for a brief period of time before they go on this 13 drug. 14 You then see them on the drug and they seem a 15 bit antsy, jumpy, et cetera, et cetera, but you don't 16 know if this isn't the normal thing for them. You're 17 heavily dependent on them being able to say to you, 18 well, look, this isn't normal for me, Doctor. And if 19 you don't ask the question, they won't say it because 20 they'll often be unsure themselves as to whether it's 21 being caused by the drug. 22 One of the interesting things about akathisia, 23 as a phenomenon, because we produced this in healthy 24 volunteers, is how even very sophisticated people get 25 blind-sided by the fact that it's the drug that's PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 778 1 causing the problem. 2 Q. Let me stop you there and ask you to explain 3 what you just said. You say, you have produced it in 4 healthy volunteers? 5 A. Yes, we have. 6 Q. Before I ask that, does this happen -- 7 akathisia happen without it being drug induced? 8 A. No. As I think I have hopefully begun to 9 indicate to you, that it may in some rare instances be 10 caused by brain injury of some sort, but it really 11 only came into the language in the 1950s in response 12 to the way people were feeling when they went on these 13 drugs which act on the serotonin and the dopamine 14 system, for instance. 15 Now, the big unfortunate thing, which you'd see 16 if I was able to put up my quotes, is that some of the 17 Swiss and German psychiatrists who described the 18 phenomenon first, who all have had a training in Greek 19 and who all would have seen the akathisia that was 20 produced by the flu epidemic that hit Europe used this 21 Greek word, this mystifying Greek word to describe 22 what they were seeing. 23 I think you would agree with me, if you saw the 24 quotes, that it would be much better to describe what 25 was happening to these patients as nervousness, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 779 1 agitation. Something in this area. Akathisia is a 2 word that mystifies people, but nervousness -- if you 3 read the quotes, you would see that nervousness and 4 agitation in lay language are the words -- and 5 actually, I can go a little bit further than this. 6 Q. I was going to ask you before you do that, to 7 explain for us how it is and in what context you and 8 your colleagues induced people to have akathisia, 9 healthy people? Could you just explain to us what you 10 did and what the results were? 11 A. Yes, I could, and I think it's highly 12 relevant -- 13 MR. SEE: Doctor, sorry. Objection, relevance, 14 Your Honor. 15 MR. VICKERY: Your Honor the relevance is 16 that -- 17 MR. SEE: May we approach? 18 THE COURT: Very well. 19 (Whereupon, the following proceedings were had 20 at side bar out of the hearing of the jury.) 21 MR. VICKERY: The relevance, Your Honor, is 22 that it is important for the jury to understand the 23 drug-induced nature of this phenomenon. What he is 24 about to tell us is something that's right there in 25 his report, that they produced this in a group of PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 780 1 healthy volunteers, and what it shows is that when the 2 phenomenon exists, it is a drug-induced phenomenon and 3 what the repercussions of that are. 4 MR. SEE: What he's about to talk about is a 5 study that he did -- 6 THE COURT: A what? 7 MR. SEE: A study. He gave some healthy 8 volunteers a drug called Droperidol. Not Prozac. 9 Droperidol. I might add, a drug known to cause 10 akathisia. And so his study that was giving a drug 11 known to cause akathisia to a bunch of volunteers and 12 then observing them while they got akathisia has 13 nothing whatever to do with Prozac, and it's very 14 prejudicial because here's a study that's not on 15 Prozac, a drug not even remotely related to Prozac, 16 and the suggestion is going to be that Droperidol does 17 this, so then Prozac must do it. 18 MR. VICKERY: That's not the suggestion at all. 19 MR. SEE: It's not relevant and unduly 20 prejudicial. 21 MR. VICKERY: That's not the suggestion at all. 22 The point is that drugs can cause that. In fact, 23 drugs are the only things that cause akathisia, and 24 number two, that akathisia causes suicide. 25 MR. SEE: None of the people in his study PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 781 1 committed suicide. 2 MR. VICKERY: Five out of the twenty who 3 developed akathisia became suicidal. They didn't 4 actually -- 5 THE COURT: I'll allow it so long as you make 6 clear that they were given Droperidol and not Prozac. 7 MR. VICKERY: Of course I will, Your Honor. 8 THE COURT: And I will sustain, and it is not 9 prejudicial, your earlier objection as to the opinions 10 he was giving. I thought your objection was to 11 akathisia, not that he had not laid foundation. 12 MR. SEE: My objection, first, was that he 13 hadn't included akathisia. Second, that there was no 14 foundation in this case to give such an opinion 15 because there's no evidence, and there's not going to 16 be any evidence that he had akathisia. 17 THE COURT: Let's instruct the jury that if 18 foundation is not ultimately laid, I'm going to strike 19 the opinion. 20 MR. SEE: Very well. 21 (Whereupon, the following proceedings were had 22 in open court in the presence of the jury.) 23 THE COURT: The Court does want to make clear 24 to the jury that in order for an expert witness' 25 opinion to stand up and be considered by the jury, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 782 1 that first a foundation has to be laid for that. I 2 allowed Dr. Healy to give his opinion, but it has to 3 be substantiated by the foundation. So if there is no 4 foundation ultimately laid for that, then the opinion 5 will be stricken. 6 Please proceed, Mr. Vickery. 7 MR. VICKERY: Thank you, Your Honor. 8 Q. Now, let's make it real clear upfront, the 9 people that you gave a drug to to produce akathisia, 10 were they healthy volunteers? 11 A. Yes. 12 Q. Let's take it real slowly through, please. Was 13 it Prozac you gave them or was it some other drug? 14 A. You're asking me to answer now? 15 Q. Yes. Yes, I am. 16 A. This is an issue that I raised in my deposition 17 with Mr. See. I said this study was relevant to the 18 question of cause and effect. This was a study where 19 we gave a drug, other than Prozac, to healthy 20 volunteers. 21 Q. And what happened when you gave it to them? 22 A. This was part of a placebo controlled 23 randomized trial. Supposedly, one of the important 24 ways to demonstrate cause and effect is to give some 25 of the people placebo or Droperidol, which is one of PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 783 1 the antipsychotics in a low dose, in a dose that we 2 didn't believe was going to cause akathisia, because I 3 wouldn't have liked to do that to these healthy 4 volunteers. If I had known beforehand, we wouldn't 5 have done it. 6 Q. You said placebo. You mean they were given a 7 sugar pill? 8 A. Sugar pill, a minor tranquilizer. 9 Q. No one in the placebo group had akathisia? 10 A. None had the akathisia. Essentially, 20 out of 11 the 20 healthy volunteers in the Droperidol group had 12 akathisia. They had visible irritability, 13 belligerence. And just to come back in a way to 14 perhaps try and make it a bit clearer to the Court, if 15 you were trying to find a good word for akathisia in 16 lay language or a good hint of what it might be like 17 to anyone who hasn't had or hadn't actually 18 experienced the phenomenon, one word I often use is 19 wired. The way you get wired after you, maybe, have 20 one or two more cups of black coffee than you're used 21 to having. You say, this is good coffee. I'll have 22 another cup, but you know this is one cup too many for 23 me. Most of you, I think, if you're like me, have had 24 the experience of just being that bit wired, charged 25 on a drug, on the coffee which is a drug. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 784 1 Now, what you find, if you're like me, is you 2 become more irritable and slightly belligerent. If 3 you're home with the children, you're quicker to snap 4 at them than you would otherwise be, and it could be 5 hard at times to recognize that it is actually the 6 coffee. You might be inclined to think I'm an awful 7 person being irritable with these kids. I really 8 shouldn't be. That's an example that I often use for 9 medical students to say it's like that, but much 10 worse. 11 Q. And Droperidol, the drug you gave them -- 12 A. Produced exactly this. 13 Q. In twenty out of twenty people? 14 A. Twenty out of twenty people became akathisic. 15 Q. These are not depressed people, but normal, 16 healthy professional people? 17 A. These were very sophisticated people. These 18 were the consultant psychiatric staff, the senior 19 medical staff in the unit, the senior nursing staff in 20 the unit. We did not want to use unsuspecting 21 volunteers off the street. We thought if we were 22 going to do this kind of experiment, we wanted to have 23 people who knew something about the facts, so we felt 24 we really need to do this on professionals. 25 Q. Did any of those 20 out of 20 who developed PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 785 1 akathisia become suicidal? 2 A. Yes. Five said that they became suicidal 3 within hours of going on the drug, and most 4 importantly, one of the contributing factors to them 5 becoming suicidal was what seemed to be a certain lack 6 of insight. They had been blind-sided by the drug. 7 You'd thought that they would know they had 8 this pill, they felt awful afterwards, and 9 particularly what they knew what these pills had done, 10 and said, look, I'm feeling this way because of the 11 drug, but they didn't. 12 And while I -- what happened, what overrides 13 this obvious logic is the fact that when we feel 14 awful, we tend to blame our emotional state rather 15 than the drug, and this is what was happening. The 16 people became suicidal, began thinking I'm feeling 17 awful because I'm a worthless human being, and it was 18 extraordinary. We had senior professional people 19 going from being highly confident people in the course 20 of an afternoon to saying, I am useless and worthless 21 and were contemplating suicide and reported afterwards 22 feeling violent and belligerent. 23 Q. When you took them off the drug, did it go 24 away? 25 A. It all cleared up. It took some time. For PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 786 1 some people it took three or four weeks for the 2 phenomenon to clear up completely. 3 Q. And does that drug that you gave them that 4 produced this state operate on the serotonin levels in 5 the brain? 6 A. It operates on the serotonin and dopamine 7 systems in the brain as does Prozac and a number of 8 SSRI drugs. 9 Q. Another question about akathisia, Dr. Healy. 10 Up until his death of a few years ago, was there one 11 guy who was sort of the world akathisia guru? 12 A. Yes. The expert in akathisia, even though the 13 phenomenon was first seen in Europe, this is something 14 you stole from us, and it was a man from the United 15 States named Theodore Van Putten who did more than 16 anyone else in the scientific field regarding the 17 dangers of this phenomenon. 18 Q. And has Dr. Van Putten written various articles 19 about this phenomenon, akathisia? 20 A. Dr. Van Putten has written very many articles, 21 a number of which include that akathisia can be an 22 entirely subjective phenomenon that is not recognized 23 by either the medical or nursing staff who are looking 24 after the patient. He drew, in particular, attention 25 to one risk of akathisia, which is you will have a PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 787 1 person who is in the hospital informally, they are not 2 detained in the hospital, and the nursing -- 3 MR. SEE: Dr. Healy, just a moment, if I might. 4 Your Honor, I object. What I understand to be 5 Dr. Healy relating to is hearsay. If there is an 6 article Mr. Vickery wants to draw his attention to, I 7 think that's appropriate. I think now he's just 8 reciting articles. 9 THE WITNESS: This is an article called, "Three 10 Faces of Akathisia." 11 THE COURT: He's relying on a treatise for his 12 opinion. 13 THE WITNESS: This is peer reviewed, published 14 work for my opinion, Your Honor. 15 Q (By Mr. Vickery) Did you say, "The Three 16 Faces of Akathisia" or the many faces? 17 A. "Many Faces of Akathisia," sorry. I've got an 18 article entitled, "Three Faces of Antidepressants." 19 This is what's confusing me. 20 Q. "The Many Faces of Akathisia" discusses this 21 phenomenon? 22 A. Yes. And what he was concerned about, in 23 particular, was a malignant phenomenon, as he 24 described it, as a person may come in the hospital, 25 may not be all that ill. They are not detained in the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 788 1 hospital. They can't be kept in the hospital, and 2 they get put on drugs. They get put on drugs, which 3 causes akathisia, and after some hours or some days on 4 this drug, they come up to the nursing staff and say, 5 look, I'm leaving, and the nursing staff don't see 6 that -- this is an individual who becomes, obviously, 7 psychotic. They don't see obvious akathisia. They 8 don't see delusions or hallucinations. They see no 9 grounds to detain this person in the hospital and they 10 let the person go. And Dr. Van Putten's view was that 11 this was the kind of situation that may well lead to 12 suicide and violence. 13 Q. Now, did that same doctor, Dr. Van Putten, 14 publish a peer-reviewed article with Wirshing in which 15 they say that Prozac causes akathisia? 16 A. Dr. Van Putten and Wirshing and Collen, there 17 were five authors on the article, published on 18 fluoxetine-induced akathisia making patients suicidal 19 and violent. 20 Q. And you said fluoxetine. You mean Prozac? 21 A. I do. 22 Q. Okay, sir. 23 THE COURT: It's 2:30 now. Let's take a break. 24 Please be back in 15 minutes. 25 (Whereupon, a recess was taken at 2:30 p.m.) PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 789 1 THE COURT: Please proceed, Mr. Vickery. 2 MR. VICKERY: Thank you, Your Honor. 3 Q. Dr. Healy, we were talking about akathisia 4 before the break, and before we leave that, I want to 5 ask you one more thing. Have you ever had the 6 situation in your own clinical practice where a person 7 developed a drug-induced akathisia and you and your 8 colleagues didn't pick up on it at first? 9 A. Yes. I think this happens very frequently in 10 my own clinical practice, Mr. Vickery. I think it's 11 the kind of condition you've got to have a high index 12 of suspicion for before you detect it, but in 13 particular relevance to this case, it happened to a 14 man who came under my care who was on Prozac, who had 15 become akathisic and suicidal, and initially, we did 16 not recognize what was happening. 17 Q. And was that incident written up by you and 18 your colleagues and published in a peer-reviewed 19 journal? 20 A. It was. 21 Q. And has that publication been made available to 22 Mr. See and has he queried you about it in your 23 deposition? 24 A. I believe he has queried me about it in my 25 deposition, but I can't quite remember that far back. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 790 1 Q. Tell us about that incident, if you would. 2 Just relate to us what happened. 3 A. Yes. We had a 67-year-old man and his wife. 4 The family looked very much like the Forsyths in some 5 respects. This was a man who had done very 6 successfully in his career. He had some nervous 7 problems, unlike Mr. Forsyth it seemed, for some years 8 and had been on an antidepressant which was a 9 monoamine oxidase inhibitor, which works in a 10 completely different way to Prozac. 11 About a year before he came to see me, he 12 was -- he had actually become depressed, clearly 13 depressed, and was being treated by one of my 14 colleagues and got put on a range of different 15 antidepressants, all of which were more like Prozac 16 and to which he didn't respond very well. 17 Now, this was in the days before the Teicher 18 report, so we had no clues as to what might be going 19 on. He was finally put on Prozac and the reports were 20 extremely interesting. His wife reported during the 21 first ten days that he went on this that there seemed 22 be a dual effect of some sort happening. On one side 23 she could see that his mood seemed to be lightening in 24 some way, but on the other hand, she could see that he 25 was becoming more tense and she couldn't put it more PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 791 1 clearly than that. She just knew things weren't 2 right. 3 Now, this was a man -- what happened? The 4 first incident that happened that brought him -- that 5 ultimately brought him to our attention was that it 6 turned out during this period of time, which we found 7 out later, that he had been thinking of committing 8 suicide. 9 Q. This period of time when he was on the Prozac? 10 A. When he was on the Prozac. This was eight to 11 ten days after he had gone on the drug first. In 12 North Wales we provide rock stone for the rest of the 13 United Kingdom, and there are a lot of large quarries, 14 deep quarries, water in the bottom, jagged edges down 15 the side, and his plan had been to go to one of these 16 quarries and throw himself in and he felt sort of 17 through falling on the jagged rocks on the way and 18 ending up in the water, this would actually kill him. 19 And he went to the edge and walked down and would wait 20 at the edge for some hours. This was in the early 21 hours in the morning while his wife was in bed asleep. 22 He left surreptitiously and came back and she queried 23 him about where he'd been and he said, oh, I've just 24 been out for a walk. And she wasn't awfully happy 25 with his explanation. She didn't know what was going PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 792 1 on. 2 Q. Dr. Healy, let me ask you to slow down just a 3 little bit for the courtesy of our court reporter, 4 okay? 5 A. I'd be very happy to, Mr. Vickery. About two 6 or three days later, he walked into the sea. Now, 7 fortunately, in North Wales, the North Wales coastline 8 is very, very flat, and you've got to walk out a long, 9 long, long way before you get out of your depth, 10 particularly at low tide. And this man walked out a 11 long, long, long way and finally when he'd got to 12 armpit level, decided that, well, no, he was going to 13 turn back and try and seek some help, and he came 14 back. 15 It was harder to get back in, than it had been 16 to get out, but he came back in and was brought to the 17 hospital. At this point he said to his wife, look, I 18 need help and was brought to the hospital, and this is 19 where he came under my care rather than the care of 20 the colleague that had put him on Prozac. 21 As one would often do in these circumstances, 22 we halted the drugs that he was on. That's one of the 23 first things one would often do. We had the natural 24 psychiatric response, I think, faced with this kind of 25 situation. A 67-year-old man who had been 40 years PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 793 1 married, who claimed he had been 40 years happily 2 married. His wife said she had been very happily 3 married, and no, they never had any arguments of any 4 sort, but our instant hunch was, you know, this man is 5 trying to commit suicide, trying to get away from his 6 wife. He really wants to divorce. He wants to 7 separate. 8 Now, I'm not saying this for the purpose of 9 this case. This is what our clinical motes were at 10 that point in time. We spent a great deal of time 11 trying to ask him questions about the underlying 12 conflicts with his wife and how it was he couldn't 13 talk about them and maybe if only he could talk about 14 them, everything would be okay, but he was stubbornly 15 resistant to this. 16 And in order to help him talk about these 17 issues, we said, look, what we'd like you to do is 18 we'd like to lie you on a bed and we'll give you some 19 Valium to relax you down and what we want you to do is 20 to almost go to sleep, get very relaxed, and to just 21 talk about whatever comes into your mind. And at that 22 point he began to talk about what came into his mind, 23 and I have to confess that I was extremely shocked, 24 because what didn't come into his mind was any issues 25 to do with his wife. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 794 1 What came into his mind was he said, well, 2 look, in between the time I went to the quarry, and in 3 between the time that I walked out into the ocean, I 4 was thinking about other ways to kill myself. I was 5 thinking about taking a serrated knife to my wrist. I 6 was thinking about getting a sharp metal object, like 7 the scissors, and sticking it into the electric mains 8 and making sure I held the earth wire on the pipe 9 coming down from the sink at the same time. 10 He couldn't explain where these thoughts came 11 from. He never had these thoughts before in his life. 12 At this stage when he recanted this, I had not read 13 the Teicher articles. This, for me, was a new 14 phenomenon. There was no evidence that he had 15 anything like this before. 16 What we did after that was to think that, well, 17 maybe the antidepressant he had been on hadn't suited 18 him. Perhaps the Prozac was part of the problem, and 19 we put him on another antidepressant called 20 Imipramine, and what we observed during this period of 21 time -- 22 Q. Let me stop you there for a minute, Dr. Healy. 23 When he was off -- when you first took him off of the 24 Prozac, did the suicidal thoughts go away? 25 A. The condition cleared up considerably. The man PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 795 1 relaxed considerably. He became a lot better. In 2 fact, we almost got to the point of thinking he could 3 go home without treatment of any sort, but given that 4 he had had nervous problems for some time, the 5 conventional wisdom would be that this kind of man 6 probably should be on an antidepressant 7 prophylactically for the purposes, not so much to just 8 try to treat the state he was in now, but trying to 9 ward off future episodes. So we put him on another 10 antidepressant, Imipramine. 11 Q. Does Imipramine operate on the serotonin levels 12 in the brain? 13 A. Imipramine is a 5-HT reuptake inhibitor like 14 Prozac. The way to compare them maybe is this, that, 15 you know, you've got Prozac which is gin and also 16 alcohol. Imipramine is whiskey and also alcohol. 17 Q. Now that's an interesting analogy. Could you 18 explain for us how that analogy might be used in terms 19 of what alcohol, in either the gin or the whiskey, 20 might cause a person to do? Can you give us an 21 example? 22 MR. SEE: Your Honor, I object to the 23 relevance. 24 THE WITNESS: Oh, I think it is very relevant, 25 Mr. See. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 796 1 THE COURT: I'll allow it. 2 Q (By Mr. Vickery) Would you explain that for 3 us, please? 4 A. Yes. Let's say, Mr. Vickery, I was to sit you 5 down here and I'll just give you some gin, a large 6 amount of gin, and you were to get drunk and people 7 were to see you get drunk. 8 Q. Okay. 9 A. If they saw this happening, they would be 10 pretty inclined to think it was the gin making you 11 drunk. If, when the gin washed out of your 12 bloodstream, you were no longer drunk, this would be 13 stronger evidence that it had been the gin that made 14 you drunk. 15 Q. Okay. 16 A. The next day we would come into court and I was 17 to sit you down and say look, today, we'll try some 18 whiskey, and I gave you some bourbon and you got drunk 19 on the bourbon. Again, people would be inclined to 20 think it was the bourbon that had made you drunk, and 21 particularly, if, as it washed out of your 22 bloodstream, you obviously came back to your normal 23 self. 24 Now, I think most people would conclude out of 25 this that what we had done is we'd shown fairly PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 797 1 conclusively that the gin, the alcohol, had made you 2 drunk in the first instance, but we had really nailed 3 the case down good and solid when we gave you more 4 alcohol the next day in the form of whiskey and made 5 you drunk again. There might be one or two people in 6 this universe who would object and say, well, we 7 didn't give you gin the second time, so we really 8 haven't proven that gin made you drunk in the first 9 instance. 10 Q. Okay. I think I follow that along. So when 11 you gave this patient of yours a second drug that 12 operates on the serotonin system, Imipramine, what 13 happened? 14 A. Well, this was very, very interesting to us. 15 And this operates a little more weakly than Prozac on 16 the serotonin system, fortunately for our patient. He 17 became over the course of about ten days on this drug, 18 visibly tenser. We did not observe him pacing around 19 more than normal, but what he reported to us was, I'm 20 feeling wired. I'm feeling tense. I'm walking around 21 much more than normal. And once we halted the 22 Imipramine, it went away completely. 23 Now, there was an interesting end to this 24 story, which was we then went back through the records 25 and looked at what antidepressants he had ever done PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 798 1 well on before and what he hadn't done well on before 2 and recognized that it was always on a monoamine 3 oxidase inhibitor, a drug which works the opposite way 4 on the serotonin system to Prozac, that he had done 5 well, okay. 6 So we put him back on that drug, and two or 7 three weeks later, this man walked out of the hospital 8 extremely well, extremely happy, and it was crystal 9 clear to us in a way that I felt very ashamed about, 10 that this man really had a marvelous relationship with 11 his wife and that our efforts to impugn the 12 relationship with his wife were really doing him an 13 injury. 14 Q. At what point in that treatment did you snap to 15 and say he had akathisia? 16 A. It was after he went on the Imipramine, and as 17 I said, became -- what had happened when he had come 18 off the Prozac before he went on the Imipramine, he 19 had begun to participate in things that were happening 20 on the ward, in group activities. He had begun to sit 21 down and talk to other patients. He had become the 22 kind of man who was helping the other patients in the 23 ward, who seemed almost too well to be there. 24 This was not the way he was when he came in on 25 Prozac and for the first few days after it had been PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 799 1 halted, and this was not the way he was when he went 2 on the Imipramine. Slowly over the course of a week 3 to ten days, he began to withdraw from contact with 4 other people on the ward. He began to become visibly 5 tense, holding himself like this (indicating). The 6 man wouldn't have sat down with the other patients in 7 the ward and try to help them sort their problems out, 8 and it was then that I recognized that what we were 9 dealing with was a drug-induced tension. A 10 drug-induced wiredness. A drug-induced nervousness. 11 That this group of drugs just did not suit this man. 12 Q. Now, is there something about that clinical 13 experience that leads you to the conclusion that you 14 stated already that Bill Forsyth developed akathisia 15 as a result of ingesting Prozac? 16 A. Yes. There's a lot about it. I think the 17 phenomenon with Mr. Forsyth mapped very well onto 18 this. We have a man who goes on the drug and within a 19 few hours or a day or two been on it, feels strange 20 and odd and seeks help in a way that's most unusual. 21 You have to appreciate, he must have been fairly 22 desperate because while people will talk about going 23 to the hospital maybe for their problems, going into a 24 psychiatric hospital, if you've never been in one in 25 your life before, has a lot of stigma associated with PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 800 1 it, but this man knew he was not safe to be out of the 2 hospital and wanted to be in a hospital fast. 3 When he went into the hospital, there's some 4 indications that the Prozac may have been stopped for 5 a day or two and his mood lightened up. That's not 6 too important. That's not an issue that we need to 7 spend too much time about. If it did happen, it 8 suggests there's a certain amount of 9 challenge/rechallenge going on in this man's case as 10 well. 11 What is awfully clear is that he then went back 12 on the Prozac and at almost exactly the same time as 13 the man that I had been dealing with, that I just told 14 you about, he -- well, during the period of time that 15 he goes on the drug, it's reported in the notes that 16 he begins to withdraw from group activities in the 17 hospital. No one quite knows what's going on. 18 What their perceptions are when he comes in 19 first is that they're a little bit surprised that this 20 man, who seems really a pretty successful man, who's 21 not obviously awfully ill has come into the hospital 22 at all in the first place. If you read the notes, 23 they're also worried and concerned now that he wants 24 to leave the hospital. They don't quite know. They 25 haven't put their finger on exactly what's wrong with PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 801 1 this man because there are good indications, I think, 2 from the notes that he had the kind of akathisia that 3 I've seen induced with Prozac and Imipramine in the 4 patient that I was dealing with. 5 He leaves the hospital in a way, that Theodore 6 Van Putten describes, that patients with akathisia may 7 do. The medical staff and the nursing staff may be 8 uncomfortable about them leaving, but they can't see 9 the grounds to detain them because the patient has not 10 become obviously deluded. They haven't started to 11 hear voices. They just feel uneasy, but they let the 12 patient go. And Mr. Forsyth had the experience that 13 the healthy volunteers we gave Droperidol to had which 14 was, it was terribly difficult to stay in one room. 15 It was terribly difficult to even stay in the 16 building. 17 Our healthy volunteers, when they got through 18 having to do the test that we were asking them to do, 19 universally tried to get out of the building. They 20 couldn't explain why. They just wanted to get out. 21 And I think this maps very, very well as to what was 22 happening to Mr. Forsyth. 23 Q. Okay. Thank you, Doctor. Now, let's talk 24 about the bases then of your opinion that Prozac 25 causes some people -- general causation, causes some PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 802 1 people to develop akathisia which then causes them to 2 become violent or suicidal. Is there some scientific 3 methodology available by which someone like Eli Lilly 4 or anyone else could test that and see if that's the 5 case? 6 A. There are three approaches you can take. There 7 is what's called the randomized-controlled trial, 8 which, I think, is generally accepted, is not the best 9 method to actually establish cause and effect in terms 10 of the adverse effects of drugs. It's a crucial 11 method used to establish -- to control investigator 12 bias when they're trying to prove a drug works to do 13 something good, but it's a very bad method to actually 14 establish cause and effect in the case of an adverse 15 event. 16 Q. Let me write these three down and then we'll 17 come back and talk about all three, in the risk of bad 18 penmanship again. Number one was randomized clinical 19 trial. Can we call it RCT for short? 20 A. That's the usual abbreviation, yes. 21 Q. Now, what's the second? 22 A. The second approach would be to look at 23 epidemiological studies. 24 Q. That's a big medical word. Tell us what that 25 means. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 803 1 A. What one looks at is, for instance, the 2 frequency of the disease in the community. You might 3 do an epidemiological study to work out exactly how 4 many people out there are depressed. You might do an 5 epidemiological study to work out how many people out 6 there are taking an antidepressant. In essence, it 7 involves trying to count the numbers of people in the 8 community or in a part of the community whom you 9 believe are representative of all the community in 10 order to work out what's going on. 11 And the other thing where it becomes relevant 12 here is you might, for instance, want to look at the 13 numbers of people in the community who are committing 14 suicide, and you could go further there, and look at 15 the numbers of people who are committing suicide on 16 particular antidepressants. 17 Q. How about people that are not committing 18 suicide, but merely thinking about it or attempting 19 it, as your patient had? 20 A. In a sense, epidemiology would be a very poor 21 tool to do this because it would involve huge amounts 22 of work in terms of you would have to interview 23 hundreds of thousands of patients. Epidemiology will 24 work where you've got a death cert, for instance. The 25 patient has died from this disease after taking this PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 804 1 antidepressant, and we can count that quickly and 2 easily, but if we had to go and interview half a 3 million people as to whether they were actually 4 feeling more suicidal, it would be a huge effort and 5 it wouldn't establish cause and effect in necessarily 6 the best way. What it would give us is a frequency 7 with which the phenomenon is happening. 8 Q. Okay. Let me write that second one down. So 9 we have the RCT and epidemiology. What is the third 10 way by which someone might test this phenomenon to see 11 if, indeed, this drug is causing this behavior? 12 A. Right. Before I just mention what it is, I 13 want to say that the people responsible in this 14 country -- most responsible in this country for 15 randomized-controlled trials and senior 16 epidemiologists in the country have said that the best 17 method for establishing cause and effect in terms of 18 the adverse effects of drugs are controlled case 19 studies involving challenge/dechallenge or challenge, 20 dechallenge, and rechallenge. 21 Q. Let me write that down. Of these three 22 methods, is one of them the best way to determine 23 causal relationship between Prozac and 24 akathisia-induced suicide or violence? 25 A. Yes, it is. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 805 1 Q. Which one? 2 A. The testimony -- the scientific testimony from 3 people responsible for controlled trials in the 4 country, from epidemiologists in the country, from a 5 number of members from a number of different 6 pharmaceutical companies is that the third way, 7 challenge, dechallenge, and rechallenge, is by far the 8 best. 9 Q. Okay. Now, Dr. Healy, before we start 10 talking -- we'll start then -- since that was the 11 best, we'll start with that one first and then discuss 12 the others, but before we do, let me ask you 13 something. You've given us one example and one only 14 from your own clinical practice to date that bears on 15 this. In the field of science, can you prove 16 something definitively where scientists will all over 17 accept it just based on what happens with one person? 18 A. Yes, you can, Mr. Vickery. Let me give you 19 two, I think, good examples. 20 MR. SEE: Objection, relevance, Your Honor. 21 THE COURT: I'll allow it. 22 THE WITNESS: Can I proceed? 23 Q (By Mr. Vickery) Yes, you may proceed now. 24 A. Yes, there's a drug or a substance, activated 25 charcoal, which is used in this country and worldwide, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 806 1 for the purposes of counteracting the effect of 2 poisonings, particularly strychnine poisoning, and the 3 discovery of this was made by a man called Pierre 4 Touri in France in, I believe, 1856, and what he did 5 was in a room, rather like this, in the French academy 6 of medicine, he said, look, if you take activated 7 charcoal, you can make sure that the person who has 8 just taken strychnine or who takes strychnine won't 9 die from it. No one in the room believed him. 10 What Pierre Touri then did was to go to the 11 podium where he had a glass made up of ten times the 12 lethal dose of strychnine. He took his activated 13 charcoal, and in front of the entire room, drank the 14 beaker full of strychnine, and walked away as healthy 15 as he was before he had it. 16 On that basis, everybody in France, all the 17 scientists in that room, believed that activated 18 charcoal was a way to counteract the effects of 19 strychnine and it's used in this country for that 20 purpose based on just that. 21 Now, let me go one step further, and I have 22 talked -- I've interviewed, as I've told you, I've 23 interviewed senior pharmacologists in the field. I've 24 interviewed Dr. Paul Leber from the Food and Drug 25 Administration, who was the section chief for the CNS PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 807 1 division. This is the division that's responsible for 2 licensing psychotropic drugs, and this is published 3 information in the public domain. This is not 4 hearsay. Anyone can read it, and you can confirm what 5 I'm going to say now. 6 What's in this published interview is the 7 following: It's commonly held that, I believe, that 8 the FDA required a drug to be shown by 9 randomized-controlled trial to work before they will 10 license it. 11 MR. SEE: Your Honor, if I may object. It's 12 beyond the scope of the report. 13 THE COURT: Sustained. 14 MR. VICKERY: Okay. 15 Q. Let's go on to our discussion here of 16 challenge, dechallenge, rechallenge. Does this have 17 anything to do with that gin and whiskey business we 18 were talking about a minute ago? 19 A. Well, yes, it does. For instance, if we could 20 use, Mr. See, yourself -- well, Mr. See in this 21 instance rather than you yourself since I picked on 22 you earlier, and if, for instance, you had -- I mean, 23 it's in the ordinary course of events in the course of 24 a long hearing like this, people in the court will get 25 drowsy and tend to fall asleep, maybe, just briefly. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 808 1 But let's say, for instance, Mr. See is not happy with 2 what I was saying and was quite worked up and alert 3 and wide awake and we were to give him a drug which 4 caused him to fall asleep 30 seconds later. A man, 5 who, in the ordinary course of events, being wide 6 awake, you wouldn't expect to fall asleep 30 seconds 7 later after the drug. Dr. Leber has said the FDA 8 would license that drug -- 9 MR. SEE: Objection, Your Honor. It's beyond 10 the scope of his report as you just ruled. 11 THE COURT: Sustained. 12 Q (By Mr. Vickery) Forget what Dr. Leber said. 13 What would be the significance to you of -- 14 A. Well, it is generally accepted by the 15 scientific community that what we had on our hands was 16 an anesthetic drug, and this had been proven in the 17 case of just giving the drug to one individual. 18 Now, if we move on from this, we took the 19 example of you having gin here in the room and you 20 became drunk. 21 Q. Is that a challenge? 22 A. That's a challenge, yes. 23 Q. You can give me gin and challenge me and say, I 24 bet you can't drink this gin without getting drunk? 25 A. We would give you gin and you would get drunk, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 809 1 I'd presume, yes. We're not actually trying to get 2 you not to get drunk, okay. We would just give you a 3 large amount of gin and you would get drunk. 4 Q. Okay. 5 A. Now, with all of the audience in the room here 6 to see you, okay, they'd all be inclined to believe 7 it, and anyone who wasn't here this afternoon who said 8 that -- who heard that 30 to 40 people had been here 9 and had witnessed this, they would also be inclined to 10 believe it. 11 On the other hand, if, for instance, everybody 12 was removed from the court and it was only you and me 13 here in the room, and I came out and told people 14 afterwards, well, I gave you gin and you got drunk, 15 they wouldn't be as inclined to believe it. It 16 wouldn't be as persuasive. 17 Now, in the case of fluoxetine and suicidality 18 and violence, what you've got is a group of senior 19 investigators. You do not have oddball reports, one 20 individual in the room with the patient saying, I saw 21 this and no one else did. You have senior people from 22 Harvard. You have senior people from Yale. This may 23 be the only thing that people from Harvard and Yale 24 have ever agreed on. You've got the world expert on 25 akathisia writing with four or five colleagues, and PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 810 1 all reporting not just that gin made one person drunk, 2 but that they gave gin to five different people and 3 they all got drunk. 4 When you've got that consistency of a report, 5 you've got very, very strong causal evidence that the 6 phenomenon is happening. You've not only got the 7 evidence that the drug is causing the problem, in this 8 case, Prozac causing akathisia and violence and 9 suicidality, you have also got the fact that when the 10 drug is reduced, the phenomenon goes away. And you 11 have a further thing that happens, if you read the 12 reports clearly, which is, that if I gave you gin, a 13 little bit of gin, and you got a little bit drunk, and 14 if I gave you more gin and you got more drunk, again, 15 people would be more inclined to believe that it was 16 the gin causing the problem. 17 And if you read the reports from Wirshing, et 18 al., from Harvard and from Yale, what you get is this 19 dose response effect. A little bit of fluoxetine may 20 cause a problem, and/or you may have the person on the 21 standard dose of fluoxetine, and when the dose is put 22 up higher, the problem appears and goes away when the 23 dose is lowered down. This is very, very strong 24 causal evidence that the drug is causing the problem. 25 Q. Now, you mentioned Harvard and Yale. Why don't PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 811 1 we start with Harvard. I want to share with you a 2 stipulation between these parties that's been read to 3 the jury already, that in 1990 Eli Lilly was aware of 4 the article published by Dr. Teicher and Dr. Cole and 5 Nurse Glod in the -- what is it -- the journal of 6 psychiatry? 7 A. The American Journal of Psychiatry. 8 Q. Okay. And are you familiar with that article 9 that was published in February of 1990? 10 A. I am. 11 Q. Are those guys Harvard guys? 12 A. Those guys are not only Harvard guys, Jonathan 13 Cole can lay claim to being the senior 14 psychopharmacologist in the field. 15 Q. The senior psychopharmacist in the field -- 16 psychopharmacologist? 17 A. Psychopharmacologist. This is the man who 18 began psychopharmacology research in this country. 19 Q. And what did Drs. Teicher and Cole report in 20 February of 1990 about Prozac inducing akathisia, 21 which caused people to become suicidal? 22 A. What was reported and what the Court needs to 23 bear in mind, what was so striking for those of us 24 from the outside when we read the report was clearly 25 you had very, very senior people who knew what PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 812 1 depression was like, who knew what suicide ideation in 2 people who were depressed was like, and who were 3 saying, look, we know suicidal ideation happens in the 4 case of people who are depressed, but what we are 5 witnessing here is something new that we have not seen 6 before, not to this degree, not this intensity. 7 It was an obsessive preoccupation with suicide, 8 violent suicide often, and in a number of cases, they 9 noted akathisia in the patients also. 10 Q. Had any of those patients previously thought of 11 violent suicide or thought of suicide at all? 12 A. Yes. I believe of the six cases, three had 13 apparently not been suicidal ever before. Three had 14 been, but none had been suicidal in this manner 15 before. I do not think you would get senior 16 psychiatrists of this kind interested to write an 17 article just about depressed people being suicidal. 18 This would not be research news. They were reporting 19 what they believed to be a new phenomenon. 20 Q. Now, did they, in those cases, dechallenge 21 them? 22 A. Yes -- 23 Q. In other words, remove the Prozac to see what 24 happens once they were taken off of it? 25 A. Yes, they did. Clearly you couldn't leave PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 813 1 people in the state that these six patients were in on 2 the drug suspecting that it may be causing the 3 problem. They halted it. The problem cleared up, and 4 in three of the six cases, I believe, when they were 5 put on a monoamine oxidase inhibitor, just like the 6 man that I've described to you earlier that we had, 7 they responded beautifully and got well. 8 And, again, I must emphasize that this is a 9 drug that works the opposite way in the 5-HT system to 10 the SSRIs. 11 Q. Now, you've told us about your own experience, 12 which you published, you've told us about the 13 experience of the Harvard guys, the Teicher and Cole 14 guys. Who are the Yalees? 15 A. This is another article by King, Riddle, and 16 colleagues, and they reported a very similar 17 phenomenon and they reported it in a younger age 18 group. 19 Q. Okay. Now, you've mentioned Dr. Van Putten, 20 the world authority on akathisia. Did he and 21 Dr. Wirshing report a similar phenomenon? 22 A. They did. They reported on a further five 23 cases. The Yale group, I believe, had five cases as 24 well. Dr. Wirshing and colleagues, there was more 25 than just Dr. Wirshing and Dr. Van Putten, reported PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 814 1 further on the five cases again and found the same 2 phenomenon that these people went on the drug, became 3 akathisic, violent, and suicidal. When the drug was 4 either halted or the dose was reduced, the phenomenon 5 cleared up. 6 Q. Is there a way that a person can stay on the 7 drug, but you can give them something else to 8 counteract it? 9 A. There is, and in the case of the 10 antipsychotics, for instance, which also cause 11 akathisia, akathisia of a slightly different kind. 12 For years people have been trying to work out, is 13 there some anecdote to this? 14 In the case of the SSRIs, Prozac in particular, 15 a number of clinicians here in the United States have 16 been giving benzodiazepines to try to alleviate the 17 phenomenon. They have people who are going on Prozac 18 and they will say to them, look, we want you to take a 19 benzodiazepine to try -- this can happen to you. We 20 want you to take a benzodiazepine to try to alleviate 21 the phenomenon or we want you to take a drug called 22 Trazodone which blocks the 5-HT(2) receptor. We have 23 a good understanding of what one of the 24 neurobiological components to producing this wired 25 feeling is, and Trazodone can help to block it. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 815 1 Now, the interesting thing is this is -- I 2 mean, this has become widespread practice in the 3 United States in order to help alleviate just this 4 problem. It has become widespread practice in Europe 5 to help alleviate just this problem. It is 6 recommended in Europe, not just widespread practice, 7 it's recommended in Europe to relieve just this kind 8 of problem, and if you look at the clinical trials 9 that were done on Prozac, drugs which might alleviate 10 the problem were -- 11 MR. SEE: Objection, Your Honor, beyond the 12 scope of the report. 13 THE COURT: Sustained. 14 Q (By Mr. Vickery) Okay. Dr. Healy, in 15 addition to those people you've talked about already, 16 the Harvard guys and the Yale guys, where are Wirshing 17 and Van Putten from? 18 A. You'll have to remind me. We'll have to look 19 at the address at the bottom. It's believed to be 20 high powered and pretty prestigious. 21 Q. Now, did a doctor named Rothschild also report 22 in peer-reviewed journals a similar phenomenon? 23 A. He did. Now, before I go on to this, I want to 24 emphasize one point. We've had -- we talked about 25 challenge/dechallenge here and we're about to go on to PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 816 1 challenge/rechallenge. I believe the 2 challenge/dechallenge data in its own right, nails 3 down cause and effect here. 4 Challenge, dechallenge, and rechallenge is the 5 icing on the cake, shall we say. If we had -- from 6 what we've explained to you, if we had Mr. Vickery 7 here having gin, and you all saw it happen, and when 8 the gin washed out of his system, things improved, 9 that's challenge/dechallenge. If we, again, gave him 10 either gin the next day, just the same form of 11 alcohol, or whiskey the next day, a slightly different 12 form of alcohol, but just the same alcohol in a sense, 13 and he became drunk again, this is challenge, 14 dechallenge, rechallenge. 15 Now, Dr. Rothschild, again linked into Harvard, 16 reported a challenge, dechallenge, rechallenge set of 17 studies on three patients. I want to emphasize, just 18 at this point, that you've heard me talk about six 19 patients from Harvard before, you've heard me talk 20 about five patients from Yale, five patients from 21 Dr. Van Putten. These are not case reports. These 22 are controlled studies. These are controlled by the 23 seniority of the investigators. These are not one 24 individual doctor in his room sitting with a patient 25 filling up a yellow card, which he sends off to the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 817 1 FDA and only he has seen the phenomenon happen and we 2 don't know for sure that it's really happening. These 3 were controlled studies, not case reports. 4 Now, Dr. Rothschild had three patients, and he 5 controlled the study even further. He gave these 6 patients Prozac. They became akathisic, violent, and 7 suicidal. They halted the drug, and the problem 8 cleared up. They gave the drug again, and it came 9 back. He used gin and gin, where we had used gin and 10 whiskey, but, in essence, he was demonstrating the 11 same phenomenon that we were demonstrating. 12 Q. And his patient that became suicidal, was the 13 way that they became suicidal by becoming akathisic? 14 A. It was, yes. In the Wirshing case series as 15 well, you will read that one of the patients was not 16 only challenged and dechallenged, but challenged, 17 dechallenged, and rechallenged again as well. So 18 there's a further element of challenge/rechallenge 19 there. 20 There's also, Mr. Vickery, another interesting 21 challenge/rechallenge that has happened in the 22 literature that's possibly worth mentioning because 23 what this takes out is the bias of the investigator, 24 et al. 25 A Dr. Cynthia Hoover -- this is just one PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 818 1 individual on her own as opposed to a group of senior 2 people from Harvard and Yale getting together and 3 agreeing on what they were seeing. Dr. Hoover 4 reported also that she gave fluoxetine to some 5 patients or to one individual patient and he became 6 akathisic and violent and suicidal. She stopped the 7 drug and it cleared up and she said, you know, based 8 on this, she believes that what's been reported by 9 Drs. Teicher and Cole has to be taken seriously. 10 A year later she was faced with the same man 11 and she gave him Imipramine, and she wrote into The 12 American Journal of Psychiatry and said, well, look, I 13 have to take back what I said about Prozac before 14 because we've given this man Imipramine and the same 15 kind of thing happened, to a milder degree, but the 16 same thing happened. What Dr. Hoover didn't 17 appreciate was that rather than doing a gin gin -- 18 challenge, dechallenge, rechallenge -- she had done, 19 inadvertently a gin, whiskey -- challenge, 20 dechallenge, rechallenge. 21 Q. With the same drugs, in fact, that you and your 22 colleagues used? 23 A. Exactly. 24 Q. Have we pretty well exhausted the reported 25 literature on challenge, dechallenge, and rechallenge? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 819 1 A. Except to say that this has been agreed by the 2 senior people in the field, the epidemiologists, the 3 randomized clinical trialists, the pharmaceutical 4 houses, and many other senior investigators as the 5 best method to establish cause and effect. What it 6 does not establish for you is how often this is 7 happening, but it establishes conclusively that it is 8 happening. 9 Q. Okay, sir. Now, let's move then to 10 epidemiology. Is there, in the published literature 11 on epidemiology, evidence which provides further 12 support for your opinion that fluoxetine, or Prozac, 13 induces suicidality in some people. 14 A. Yes, I believe there is, and this is an area 15 that I've been working on fairly extensively. And 16 Dr. Hershel Jick published in the British Medical 17 Journal in January or March of 1995, an 18 epidemiological study which looked at over 172,000 19 people who have been prescribed an antidepressant in 20 primary care in the United Kingdom. 21 Q. 172,000 people? 22 A. 172,000 people. 23 Q. Let me stop you before you go further. You 24 said this was published in January of '95? 25 A. January of 1995. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 820 1 Q. Prior to that time, had you already arrived at 2 the opinion that Prozac causes some people to become 3 akathisic, which then caused them to become suicidal 4 and violent? 5 A. Yes, I had. In two articles, the case reports 6 that we wrote up, and a peer-reviewed review of the 7 problem, which I'd written up in 1994, before I knew 8 anything about the Jick study. 9 Q. Okay, sir. Now, tell us about the Jick study. 10 What did they study with this 172,000 people? 11 A. Well, this was not a study that was designed, 12 in the first instance, to investigate whether Prozac 13 caused people to become violent and suicidal. So 14 Dr. Jick, as far as I'm aware, had no axe to grind 15 against Prozac, or any other antidepressant. Probably 16 the primary concern was a drug called Prothyadin in 17 the United Kingdom, which was the drug that had been 18 used most frequently in the United Kingdom at the 19 time. 50 percent of all of the prescriptions for 20 antidepressants, was this particular drug, and the 21 problem with it was it was dangerous in overdose. 22 Dr. Jick set out -- 23 Q. Let me stop you right there. Let's clear that 24 up. When you say, "dangerous in overdose," you mean, 25 as poison, people could kill themselves by taking too PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 821 1 much of it? 2 A. Yes. 3 Q. Can you do that with Prozac? 4 A. No, you can't. 5 Q. Okay. Please proceed and tell us about 6 Dr. Jick. 7 A. Right. Dr. Jick and colleagues, what they were 8 able to do, which you can do -- I mean, it's actually 9 quite easy to do this. In the United Kingdom, primary 10 care physicians all -- well, it isn't true for all of 11 them, but it is true for a great number of them. 12 Their prescribing is all done through a computer, and 13 the computers are all linked up together to a network, 14 so what Dr. Jick was, very easily and at very little 15 cost, was able to do was to get the data from the 16 172,000 scrips for an antidepressant in primary care 17 in the United Kingdom. 18 What he was then able to do was to establish 19 which or how many, if any, of these 172,000 people who 20 had gotten an antidepressant had gone on to commit 21 suicide and he found that something like 172 -- no, 22 it's not 172. 23 Q. Is it 187? 24 A. No, it's not. But anyway, he found a 25 particular number of people had gone on to commit PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 822 1 suicide, and he broke this down according to the 2 numbers of people who had committed suicide on each 3 drug and he broke it down also according to the number 4 of people who have been prescribed each drug. So he 5 was able to work out what the rates were per 6 prescription, the likelihood, if you were prescribed a 7 particular antidepressant, and he looked at ten 8 different antidepressants, what the likelihood was 9 that you would end up committing suicide if you were 10 put on this antidepressant. 11 Q. And what did he conclude? 12 A. Well, I have some tables that I could show the 13 jury exactly his finding, if we can show them. 14 Q. Okay. I believe we can do that. Okay. 15 Dr. Healy, I'm going to show you for identification 16 purposes, it is Plaintiffs' Exhibit 155, and it was 17 used for demonstrative purposes. 18 It says, "Antidepressants and Suicide," by 19 Susan Jick, Alan Dean, and Hershel Jick, and now, I 20 understand that the jury doesn't get scientific 21 articles, but other people may be talking about. When 22 we look at one, what is the abstract? 23 A. The abstract is where the authors present the 24 major conclusions and this is what, for instance, will 25 go on to the Internet. If any of you were trying to PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 823 1 search for evidence on an issue, you would put in, for 2 instance, the word suicide, perhaps, and 3 antidepressants and what would come out, will be the 4 names Jick, Dean, and Jick and this article, plus the 5 abstract, so you could see what the major conclusions 6 were, and if you wanted to get the whole article. You 7 wouldn't see the whole article, you would see the 8 abstract. 9 Q. Let's move it up and see what one of the major 10 conclusions was here. 11 Ms. Barth, if you would handle that part I've 12 highlighted. 13 And I'll just read this, Dr. Healy. "Rates of 14 suicide were higher in patients who received 15 fluoxetine, but this may be explained by selection 16 biases which were present for those drug users." 17 Okay, sir. Which of the three charts that you 18 have prepared from the Jick study would you like to 19 use first to illustrate the significance of this 20 study? 21 A. I have a chart which gives the absolute numbers 22 per 100,000 patient years. The figure 187 for Prozac 23 should be on it. It's labeled number one down in the 24 right-hand corner. 25 Q. Yes, there it is. Thank you. I appreciate you PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 824 1 doing that for me. 2 A. Essentially, the Court needs to look at the 3 right-hand column. What you've got on the top -- I 4 can't actually see this. Do we have a copy for me? 5 MR. VICKERY: Would it be permissible for 6 Dr. Healy to step down to the set? 7 THE COURT: Yes. 8 THE WITNESS: I'm a shade short-sighted, Your 9 Honor. 10 THE COURT: Well, it is pretty difficult to 11 read. 12 THE WITNESS: The antidepressant that was of 13 most concern to begin with was this antidepressant up 14 at the top, Dothiepin. It is called Prothyadin in the 15 United Kingdom, but this is what's called the 16 reference antidepressant. It's the reference 17 antidepressant, because it was the one that was used 18 the most and all of the other antidepressants are 19 going to be compared to that. 20 On the next line here you see -- well, on the 21 top line you see the rates of suicide that are 22 associated with taking Dothiepin per 100,000 patient 23 years, and you've got 85 suicides. The figure for 24 fluoxetine is 189 per 100,000 patient years. Now, I 25 want -- PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 825 1 Q. (By Mr. Vickery) Excuse me, Dr. Healy, what's 2 a patient year? 3 A. Well, this is the number of people who are on 4 this drug during the course of the year, who are 5 actually exposed to the drug during the course of the 6 year. 7 Q. Okay, sir. 8 A. If 100,000 people have been exposed to this 9 drug during the year, they are predicting 189 people 10 will commit suicide. 11 Q. Okay. 12 A. The next drug we'll have to look at here is 13 Lofepramine, which is 47. I want you to look at three 14 other drugs here at the bottom of the chart, which are 15 quite high figures as well. One of them is a drug 16 called Mianserin, and the other drug is called 17 Trazodone. Mianserin is 165, Trazodone is 148, and 18 Flupenthixol is 120. 19 Q. What's the significance of those three? 20 A. Well, what I'm going to show you is this: When 21 we control for all of the other things that we know 22 are associated with people committing suicide, like, 23 the older you are, men are more likely than women, 24 whether you've had a previous effort to try and kill 25 yourself; these issues, when we control for all of PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 826 1 these things, the figures for these three drugs fall 2 back down towards a hundred. The figure for 3 fluoxetine stays exactly the same. 4 Now, I want you to notice two or three more 5 things. It is very simple. You see this drug -- this 6 drug, Lofepramine, this is the only -- which has the 7 lowest rate of suicide. This is the only drug where 8 just -- this is the only drug that does not act on the 9 5-HT system -- 10 Q. You mean, the serotonin? 11 A. Yes. 12 Q. Prozac and serotonin. 13 A. I'm very sorry, yes. This is the only drug 14 that does not act on the serotonin system, and the 15 other thing that's very important here, a man -- a 16 group, a large group, headed by a man called Isacsson 17 in Sweden, looked at all suicides in Sweden during the 18 course of the year and he gets almost -- now, they 19 didn't, at this point, and this is 1991, 1992, they 20 did not have Prozac in their trial because Prozac had 21 not been licensed in Sweden, but the other 22 antidepressants, they have, and they come up with the 23 exact same rank order of how likely these were to be 24 associated with you committing suicide. Not only 25 that, they're almost exactly the same figure for PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 827 1 Lofepramine here. So this Jick study maps very well 2 to other large epidemiological studies that were being 3 done. 4 Now, one more point for you. These three other 5 drugs, which have high figures here, two of them, 6 Mianserin and Flupenthixol, have not been let on the 7 market in the USA. Flupenthixol is a drug that 8 notably causes akathisia. All right. We want the 9 next table. 10 Q. Tell us what this table shows in significance. 11 A. Right. The instant here -- what we've done 12 is -- well, what Dr. Jick did was to convert the 13 absolute figures over 200 odds ratio, how much more 14 likely it is for fluoxetine to be associated with 15 suicide than the reference antidepressant Dothiepin, 16 and he's saying it's 2.1 times more likely. 17 Now, the significance of this is 18 epidemiologists -- for instance, if we take the breast 19 implant problem, when people -- 20 MR. SEE: Your Honor, objection to relevance. 21 THE WITNESS: I'm trying to show what an 22 epidemiologist would be concerned about. 23 THE COURT: I'll allow the question and the 24 answer. 25 THE WITNESS: In the case of breast implants, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 828 1 no one could show that the rates which people had 2 breast implants was greater than two times of breast 3 tumors and other problems like connective tissue 4 diseases than in women who hadn't gotten breast 5 implants. So this is pertinent. This is where the 6 scientific community gets the point, saying, what we 7 really want to see before we really get concerned here 8 is a rate of at least two times greater. What you see 9 here is a rate of 2.1 times greater. 10 Q. (By Mr. Vickery) Dr. Healy, can you explain 11 for us, real simply so that I can understand it, why 12 the scientific community wants to see a rate of at 13 least two times greater? What's so magical about two 14 times greater? 15 A. Well, generally the feeling would be that, 16 while it may be that women who go for breast implants, 17 for instance, have some other factors that might 18 predispose them to the actual diseases that are then 19 being attributed to the implants, but once you get up 20 to a rate of two times higher than the rest of the 21 population, that's when you say, look, that there's 22 something going on with the breast implants. 23 Q. Let me ask you something. It shows that 24 fluoxetine or Prozac is 2.1, but right after that, it 25 says 1.1 to 4.1 in parentheses. What is the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 829 1 significance of that range of numbers? 2 A. This is what's called the confidence interval, 3 and this was a notion that was introduced by the 4 British Medical Journal, in which this article had 5 been published. Dr. Jick would not have been able to 6 publish the results in the British Medical Journal 7 without including the confidence interval. 8 What the confidence interval allows lay people 9 in the jury or in the court or scientists or anyone to 10 see what the range of values for fluoxetine compared 11 to this antidepressant, Dothiepin, might be. And what 12 he's say is, at a very high level of statistical 13 significance, it will always be higher. It is 14 unlikely to be as low as one, and he's saying it could 15 go up to 4.1 times higher. What he's saying here is 16 that nobody -- well, what he's actually saying to all 17 of you is if you have to put your money on a 18 particular figure, put it on 2.1. 19 What he's also saying to you is if the 20 representative from Eli Lilly here in the courtroom, 21 and I don't know that there are, that they couldn't 22 say to you for sure that fluoxetine isn't 4.1 times 23 more likely to be associated with suicide than the 24 reference antidepressant defined. 25 Q. Okay. Are we through with that particular PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 830 1 table? 2 A. We are. 3 THE COURT: Well, let's stop for the day now. 4 Please be back at 9:00 tomorrow morning. I want to 5 meet a minute with counsel. 6 (Whereupon, the following proceedings were had 7 in open court out of the presence of the jury.) 8 THE COURT: I want to see counsel at side bar. 9 (Whereupon, the following proceedings were had 10 at side bar.) 11 THE COURT: Before Dr. Healy testified and 12 Mr. Vickery had asked to have a whole bunch of 13 exhibits admitted, and you objected on the basis of 14 some evidence might go beyond the scope -- 15 MR. SEE: Yes. 16 THE COURT: -- and I ordered that he couldn't 17 go beyond the scope. 18 MR. SEE: Yes. 19 THE COURT: Is there any objection to those 20 coming in now? 21 MR. SEE: I think Your Honor has already ruled 22 on them. 23 THE COURT: I ruled at the time of the -- I 24 don't know the number for number, but do you have any 25 objection to those coming in. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 831 1 MS. MANGRUM: Those exhibits? 2 MR. SEE: Yes. There is one, I know, these 3 slides of Dr. Healy's that is not admissible, so I 4 presume that one was withdrawn. 5 MR. VICKERY: Yes, Mr. See is right. 6 Mrs. Mangrum pointed out to me it was demonstrative 7 only. 8 MR. SEE: And, Your Honor, I think Your Honor 9 has already ruled on our objections. 10 THE COURT: Right. I think I ruled on all the 11 objections. 12 MR. SEE: I think that you have. 13 THE COURT: I just wanted to know procedurally 14 whether you had any objections. 15 MR. SEE: Well, the only procedural objection I 16 had is somehow to admit the exhibits in mass at this 17 time permits the witness somehow to go beyond the 18 scope of his report. 19 THE COURT: No. 20 MR. SEE: I take it that won't happen as Your 21 Honor has ruled on the exhibits. I don't have any 22 particular objection. 23 THE COURT: All right. Well, they're in. 24 MR. VICKERY: Thank you. 25 MR. SEE: Your Honor, I have two very short PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 832 1 matters, and I'd like to ask the Court to give the 2 jury an instruction about breast implants. 3 THE COURT: You may go back to your seat. 4 (Whereupon, the following proceedings were had 5 in open court out of the presence of the jury.) 6 MR. SEE: I don't know if this can be cured 7 with an instruction, but it's the only thing I know to 8 ask for. First it was Phen-Fen and now it is breast 9 implants. 10 Your Honor, we filed a motion in limine before 11 we even got started going right to this issue, that 12 other products in litigation don't have anything to do 13 with this, and now Mr. Vickery has brought up, not 14 one, but the second time, about breast implant 15 litigation. He didn't use the word "litigation," but 16 I doubt that there's any person in the state that 17 doesn't know about the enormous breast implant 18 litigation. 19 So I think at a very minimum, and I don't even 20 know if it can be cured here, but that's all I know to 21 ask for. I request that the Court give the jury an 22 instruction that any mention of breast implants 23 doesn't have anything to do with whether Prozac causes 24 suicide or homicide or whether it caused it in this 25 man. I mean, the clear implication is there. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 833 1 THE COURT: Mr. Vickery. 2 MR. VICKERY: Your Honor, I'm uncertain of what 3 order it is that he thinks I have violated. He wanted 4 me not to talk about other litigation, and he wanted 5 me not to talk about other Lilly products. I've done 6 neither of those things. 7 With respect to what happened this afternoon, I 8 had no idea that Dr. Healy was going to use breast 9 implants as an example, and I don't even know if he 10 knew. It may have just popped into his head at the 11 time as an example, but certainly the example in the 12 way it was used, doesn't hurt Mr. See. In fact, it 13 does exactly the opposite. 14 What he just, basically, told the jury was that 15 there is no valid scientific proof of problems from 16 breast implants. So to the extent that anybody in 17 there had some preconceived notion about litigation, 18 which he said nothing about litigation, in fact, it 19 would help Mr. See. 20 However, having said all of that, I certainly 21 have no objection to the Court saying something to the 22 jury about not to consider other litigation or not to 23 consider -- that this case is not about breast 24 implants. It was just an example that popped into 25 Dr. Healy's head. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 834 1 THE COURT: Well, I didn't think that it 2 related to litigation, but I will instruct the jury 3 that breast implants have nothing to do with the 4 issues in this case. Is that satisfactory for both 5 counsel? 6 MR. SEE: That will be satisfactory, Your 7 Honor. 8 MR. VICKERY: Yes, it will. 9 MR. SEE: And I want to specifically ask the 10 Court to instruct Mr. Vickery and his witnesses -- I 11 mean, make the list, cigarettes, Dow Con Shield, 12 thalidomide, Bendectin, I mean, I expect them all to 13 sort of pop out as products that people think cause 14 injury, and we're in a case where Mr. Vickery wants 15 the jury to believe that products, and especially, 16 medical products, cause people injury and it is very 17 unfair and I resent his doing it. 18 MR. VICKERY: I resent the implication, Your 19 Honor, that I'm trying to do anything. 20 THE COURT: I'll reiterate the instruction. 21 MR. VICKERY: Fine. 22 MR. SEE: The other matter is this, Your Honor: 23 We have now had from Dr. Healy a discussion of -- 24 although, now he's claiming they are not case 25 reports -- about five or six medical articles, which PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 835 1 are, in fact, case reports. So I think we really 2 ought to have Your Honor resolve the instruction that 3 the parties worked on. The first part of that 4 instruction is agreed to and then Mr. Vickery has 5 asked to tack on a little part at the end that I 6 object to, but I believe it's been submitted. 7 THE COURT: All right. I'll do that overnight. 8 MR. VICKERY: All right. 9 MR. SEE: Very good. 10 THE COURT: We'll see you at 9:00 tomorrow. 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 836 1 (Whereupon, the proceedings were adjourned at 2 4:03 p.m. to be reconvened on March 11, 1999 at 3 9:00 a.m.) 4 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 837 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 10, 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