128 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. ) 6 Forsyth and William D. ) Pages 128 - 232 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 hearing on 16 Thursday, March, 4, 1999 at 1:35 p.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 129 1 APPEARANCES: 2 For Plaintiffs: ANTHONY ANDERSON VICKERY, ESQ. Archer, Waldner & Vickery 3 2929 Allen Parkway Suite 2410 4 Houston, Texas 77019 5 For Defendant: ANDREW SEE, ESQ. MICHELLE R. MANGRUM, ESQ. 6 Shook, Hardy & Bacon L.L.P. One Kansas City Place 7 1200 Main Street Kansas City, Missouri 64105 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 130 1 THE CLERK: Civil No. 95-00185 ACK, Susan K. 2 Forsyth, et al. versus Eli Lilly and Company, et al. 3 May we have appearances, please. 4 THE COURT: We'll get to that before the trial 5 is over, I hope. When we start, we make appearances. 6 MR. VICKERY: Oh, I'm sorry, Your Honor. I 7 always waited for her to ask. I thought that was the 8 proper thing to do. My name is Andy Vickery. I'm 9 here for the Forsyths. With me at counsel table is my 10 paralegal, Rhonda Hawkins, Your Honor. 11 THE COURT: Good afternoon. 12 MR. SEE: Andrew See and Michelle Mangrum for 13 Eli Lilly and Company. 14 THE COURT: Well, the Court has completed his 15 review of the hundreds of objections here, and I take 16 it, you still are not in agreement as far as the FDA 17 documents that Mr. Vickery mentioned in his letter of 18 March 1, 1999? 19 MS. MANGRUM: That's correct, Your Honor. 20 THE COURT: What's good for the goose is good 21 for the gander. 22 MS. MANGRUM: Yes, Your Honor. 23 THE COURT: As far as all of the exhibits, any 24 reference to other entries or non-indicated uses 25 should be redacted. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 131 1 The Court has carefully applied to each of 2 these exhibits an analysis under Rule 402 and 403, and 3 I assume the parties don't want me to go through the 4 analysis with respect to each of the numerous 5 objections; is that correct? 6 MR. VICKERY: The plaintiff does not, Your 7 Honor. 8 MR. SEE: At this time, I don't see a need for 9 that, Your Honor. I suppose if the Court would 10 entertain a question, if there is one -- 11 THE COURT: Oh, yes, I will. And under 403, 12 I've reviewed each one of these exhibits and I find 13 that the probative value is substantially outweighed 14 by danger of prejudice or confusion of the issues or 15 misleading the jury or of considerations upon due 16 delay, waste of time, cumulative evidence, I have 17 applied Rule 403. I'm not going to get into a mini 18 trial on what went on with the FDA or the BGA, as I 19 indicated in the in limine ruling. Some of that is 20 admissible as far as notice to Lilly, in which case it 21 is not admissible for the truth, but just notice. 22 Now, there is some case law that pertains to 23 the FDA documents that neither party cited to the 24 Court, but basically, the McClintock case holds that 25 non-final determinations by the FDA should not be PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 132 1 admitted, except in this case, if they're being 2 admitted for notice to Lilly and then it would not be 3 for the truth. 4 And then at the end of our discussion today, if 5 I have failed to address any objections that need to 6 be addressed, please let me know because there are so 7 many that we may have overlooked some. 8 So turning to the plaintiffs first exhibit, 9 Exhibit No. 1, which I understand, is a U.S. warning 10 for Prozac, 1987 warning. Is that a final warning at 11 that time? 12 MR. VICKERY: That's my understanding. That's 13 the final warning they were using in 1987. 14 MS. MANGRUM: Your Honor, that's not the final 15 warning. You'll note that in that document it says in 16 brackets, "Note to firm," and what you see there is 17 the FDA's note when the final insert was being 18 discussed with the FDA between Lilly and the FDA. 19 Certainly in that form, it never went out to the 20 public, any physician, or anyone other than Lilly. 21 THE COURT: Well, you two can determine that, 22 but if it's not final, then I'm not going to admit it 23 under the McClintock ruling and 402 and 403. 24 MR. VICKERY: But, Your Honor, this is not an 25 FDA document. It's a Lilly document, drafted by Lilly PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 133 1 not the FDA. And so anything -- I don't want to start 2 this whole thing by arguing with the Court. 3 THE COURT: That was drafted by Lilly? 4 MR. VICKERY: Yes, these warnings were drafted 5 by Lilly, not the FDA, and if I've misspoken and if 6 Ms. Mangrum is correct that they said, "note to firm," 7 that would, indeed, be a FDA note to the firm, but the 8 document itself is a Lilly admission. 9 MS. MANGRUM: "Note to firm," here on Page 295. 10 This is part of the approvable letter, Your Honor, a 11 letter from the FDA to Eli Lilly and Company saying, 12 "If certain conditions are met, we will approve this 13 drug." It was before the drug was approved. It is 14 part of a letter dated September 9, 1987 from FDA to 15 Lilly. 16 THE COURT: Very well. I will admit it then 17 only for notice to Lilly and not for the truth of the 18 matter. 19 The next exhibit is No. 4, and I had a question 20 as to who prepared that one. It seems to be -- it 21 says that the package insert for Fluoxetine, Dr. Dobbs 22 and Dr. Burgstrom. I don't know who they are. 23 MS. MANGRUM: Your Honor, Dr. Burgstrom and 24 Dr. Linberger are both clinical pharmacologists that 25 do pharmacokinetics and bioavailability studies at PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 134 1 Lilly. They are Ph.D.s not M.D.s. This is a draft 2 insert that was prepared by Lilly and being circulated 3 four years before the drug was ever approved by the 4 FDA. 5 My relevance objections to this document, Your 6 Honor, are really those of proximate cause, because 7 the statements that Mr. Vickery points out are 8 patients who are considered possible suicides, should 9 be hospitalized or should be considered for 10 hospitalization. Mr. Forsyth, in this case, was 11 hospitalized, so the fact that that very statement did 12 not appear in the final warning certainly could not 13 have been the proximate cause of Mr. Forsyth's 14 injuries. 15 THE COURT: Mr. Vickery. 16 MR. VICKERY: Well, he was hospitalized on 17 March 3rd, Judge. He was released from the hospital 18 on March 3rd and sent home, and it was that night -- 19 THE COURT: Well, he had been in the hospital a 20 week. 21 MR. VICKERY: I understand that. I understand 22 that. But if someone had been warned that he may need 23 to stay in the hospital, then he might have stayed in 24 the hospital. 25 THE COURT: You mean everyone who takes Prozac PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 135 1 should stay in the hospital for how many weeks? 2 MR. VICKERY: Don't know the answer to that, 3 but I know that Lilly -- Lilly people prepared 4 warnings about Lilly's suggesting that people that 5 were at suicidal risk, should be hospitalized. 6 Now, Mr. See told the Court at side bar the 7 other day that they thought Mr. Forsyth was a suicidal 8 risk. He's going to try to say before Prozac. I say 9 not until he took it, but clearly he was a suicidal 10 risk when he was in Castle Medical Center. So the 11 fact that Lilly scientists said you need to warn, the 12 people on suicidal risk should be in a hospital is 13 extremely germane, particularly since it's in 1983, 14 four years before approval. 15 MS. MANGRUM: Your Honor, I would just 16 reiterate, having that in here wouldn't have changed 17 anything because it happened in this case -- 18 THE COURT: Pardon me? 19 MS. MANGRUM: Having that warning in the 20 insert, as Mr. Vickery claims we should have, would 21 not have changed anything in this case. This man was 22 hospitalized. Having it in there, would not have 23 changed a thing. Mr. Vickery then argues, well, it 24 doesn't say how long they should stay, but this 25 document doesn't say that either. This document PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 136 1 cannot be used to support that proposition. 2 THE COURT: I'm going to allow that under 402 3 and 403, prepared by Lilly. 4 I do have a question, just for my edification, 5 how long -- there's some indication that, I think at 6 least by the German label, that a person should be 7 under close supervision until remission sets in, and 8 how long a period of time is that? 9 MR. SEE: I think that would vary with every 10 individual, Your Honor. And I might point out to the 11 Court, that in the United States' insert, it basically 12 says the same thing. 13 THE COURT: What time frame -- I understand it 14 varies from individual to individual, but basically, 15 in general, what time frame would that be? I mean, 16 would it be one day to two weeks or two weeks to four 17 weeks? 18 MR. SEE: In a general way of thinking, neither 19 Prozac nor any other antidepressant really becomes 20 effective, starts having antidepressant effect until 21 two to three weeks. Now, when is a suicidal risk 22 abate in that person or any person having depression? 23 It really just depends on the person. 24 I think it's a common rule of thumb these days 25 that antidepressants are given for a trial, about six PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 137 1 months, and then the person is kind of taken off and 2 see, are they okay? So, I think it really depends on 3 the person, but clearly the warning in the U.S. insert 4 is -- 5 THE COURT: I understand, but I just wanted to 6 know that for my own purposes. 7 No. 5, this is prepared by Lilly also, correct? 8 MS. MANGRUM: Correct, Your Honor. 9 THE COURT: The Court will allow this as far as 10 notice for Lilly, admission by Lilly. 11 And No. 6 -- 12 MS. MANGRUM: Your Honor, my argument on this 13 one is not the foreign regulatory activity argument 14 that we raised in our in limine motions, rather it's 15 again, proximate cause. The German warning says that 16 the patient should be observed closely, and 17 Mr. Forsyth was observed closely. It says, "Perhaps 18 you should give calming medicines or anxiolytics or 19 medicines to make the person less nervous." And in 20 fact, Mr. Forsyth, during the time he was receiving 21 Prozac, received those medicines; Xanax, Inderal, and 22 then Desyrel, all of which have those properties. 23 So having the German warning in the United 24 States would not have changed the behavior in this 25 case because what Dr. Riggs Roberts did and what PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 138 1 Dr. Neal did was exactly what is specified in the 2 German warning, so to the extent Mr. Vickery is trying 3 to claim that the U.S. warning was inadequate because 4 it did not contain that language, that language would 5 not have changed anything and that alleged inadequacy 6 could not have been the proximate cause because those 7 exact things occurred in this case. He was given 8 additional medication and he was hospitalized and 9 observed closely. 10 THE COURT: Mr. Vickery. 11 MR. VICKERY: Your Honor, I think it's a 12 question of degree and of clinical judgment. I think 13 that the German warning says, "risk of suicide." The 14 fact that a doctor might have, for some period of 15 time, either given an anxiolytic, which is not the 16 concomitant sedative, by the way, that was recommended 17 in Germany, or monitored them or had them in the 18 hospital doesn't necessarily mean that with a more 19 explicit warning that told that there was a risk of 20 suicide, that they might not have taken greater 21 measures and particularly, when we get to the point of 22 discharge on March the 3rd. 23 THE COURT: Well, there's a precautionary note 24 concerned about suicide, isn't there, suicide and 25 violence? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 139 1 MR. VICKERY: Yes, there is. And the question 2 concerns -- the jury question here is whether the 3 warning is legally adequate under the Ontai case under 4 Hawaii law. A precautionary note, as the Court's seen 5 I'm sure, under the federal regulations. There's a 6 difference between what the federal government calls 7 box warnings and precautionary notes. 8 A precautionary note hidden in the small print 9 of the package insert is a very different thing than 10 an explicit expressed warning, particularly when you 11 compound it by the kinds of letters we've seen, the 12 seven-page letter that the missing Dr. Beasley wrote 13 to Dr. Roberts which downplays any significance of any 14 warning or precaution in the package insert. 15 THE COURT: Well, I'm going to allow six. 16 Again, that's only going to be for notice and not for 17 the truth. 18 And likewise on 8, 9, 10, 11, and 12, I'm going 19 to allow those for notice and not for truth. 20 No. 14, what's the relevance of this? 21 MR. VICKERY: The relevance is, Your Honor, 22 that it shows that they expect questions, as I say 23 here, that the marketing people expect that doctors 24 are going to raise certain questions, and that they 25 prepare their marketing folks in advance to how to PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 140 1 respond to those questions. 2 THE COURT: This talks about serotonin and the 3 uptake. I'm not going to allow this one under 402 and 4 403. I am going to allow other marketing instructions 5 though. 6 MR. VICKERY: Okay. 7 THE COURT: No. 15, I will allow. Again, it 8 would be statements from the medical articles are not 9 going to be offered for the truth, but for notice to 10 Lilly. 11 No. 16, the Court will allow. Likewise, No. 12 17, but the Court will require that any reference to 13 pending -- other pending litigation be redacted. 14 No. 19, the Court is not going to allow, 402 15 and 403. This refers more to doses over and above the 16 amount we're concerned with. Likewise, the Court had 17 a motion in limine concerning lesser doses. 18 No. 20, the Court will allow. 19 No. 21, the Court will allow. Marketing 20 instructions prepared by Lilly. 21 No. 24, the Court has a question as to why 22 that's relevant? These are FDA guidelines. 23 MR. VICKERY: I'll withdraw it in the face of 24 the objection. It's a lengthy exhibit and I don't 25 think it would help the jury anyway. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 141 1 THE COURT: Okay. Thank you. Two points for 2 you. 3 MS. MANGRUM: Your Honor? 4 THE COURT: Yes. 5 MS. MANGRUM: On your rulings regarding 6 Exhibits 16 through 21, which are the same type 7 documents, the documents sent to Dista Select and 8 sales representatives, I would ask that the Court 9 reconsider those rulings in light of this: That all 10 these documents are going to be used by Mr. Vickery to 11 show one thing and that is that Lilly was somehow not 12 forthcoming and hiding facts by telling its sales 13 representatives not to raise this subject. When on 14 Mr. Vickery's list is a dear-doctor letter as 15 Exhibit No. 22, and also a letter to Dr. Riggs Roberts 16 concerning these very, very issues and Dr. Roberts has 17 testified that before he ever prescribed Prozac for 18 Mr. Forsyth, he knew of the Teicher article and he 19 knew of this discussion of suicidality possibly 20 related to Prozac. And again, he's got the 21 dear-doctor letter. He knew all of this. 22 So any actions that Mr. Vickery is trying to 23 show here, in the face of his other exhibits, will 24 show that Lilly medical took great steps to tell 25 doctors about this very issue. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 142 1 THE COURT: Mr. Vickery. 2 MR. VICKERY: I think that's a jury speech, 3 Your Honor. I think she needs to let the jury decide 4 what weight to give the evidence. The evidence is 5 relevant because it's clear that Lilly, A, withheld 6 information, but B, sent out other information 7 intending to reassure and placate doctors' concerns. 8 I have a totally different view of the letter 9 from Dr. Beasley to Dr. Roberts than does Ms. Mangrum. 10 My view is, is Lilly hiding the ball and saying, 11 here's the Teicher article, but don't worry about it. 12 THE COURT: I'm going to allow it. I'm not 13 going to change my ruling on that. 14 25, the CFR, you're going to limit your -- the 15 number of pages on that, Mr. Vickery? 16 MR. VICKERY: Yes, I am, Your Honor. In my 17 response column, I indicated those sections that we 18 were offering. 19 MS. MANGRUM: I would object to that, Your 20 Honor, simply because it's law that he may impeach 21 someone with knowledge on that topic of any witness he 22 wants to ask about the labeling, but certainly it is 23 strictly law. 24 THE COURT: But aren't you asking for the same 25 thing in some of your exhibits? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 143 1 MS. MANGRUM: Yeah, we're asking for an 2 instruction to the jury on that. 3 THE COURT: You're asking for a regulation, as 4 I recall, concerning pharmaceutical drugs. 5 MS. MANGRUM: I believe that's just as a 6 demonstrative evidence -- demonstrative exhibits, Your 7 Honor. Those are blowups of those portions for the 8 jury to see, but we're certainly not asking that the 9 Court allow them to be published to the jury, they can 10 take them back to the jury room with them. 11 THE COURT: I'll allow you to use this for 12 cross-examination or for jury instruction. 13 MR. VICKERY: Okay. 14 THE COURT: No. 26, I'll allow that on 15 cross-examination only. 16 Twenty-eight, the Court is not going to allow 17 that under 402 and 403. 18 No. 30, the Court's not going to allow that 19 either. However, as far as akathisia being related to 20 it and restlessness, you can use that portion on 21 cross-examination. 22 Same thing with respect to 32, 402 and 403 23 preclude that as being admitted. 24 Thirty-three, the Court will allow the first 25 two paragraphs, but redact the balance. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 144 1 Thirty-nine, the Court is not going to allow 2 that on dog toxicity. 3 Forty-two, the Court will admit that only as to 4 notice and not for the truth. 5 Forty-three, what's the relevance of that? 6 MR. VICKERY: The relevance, as I said in the 7 paragraph, Your Honor, is that it shows that Lilly, in 8 effect, ghost writes scientific papers. That they 9 come in and talk about all this scientific research, 10 and I want to show the jury that a lot of this 11 scientific research by purportedly independent people 12 is really authored by folks in Lilly. It says, 13 "Here's a copy of your paper" -- 14 THE COURT: I'm not going to allow it to be 15 admitted, but you may use it for cross-examination. 16 MR. VICKERY: Okay. 17 THE COURT: Forty-five, Schenk Weber are Lilly 18 people? 19 MS. MANGRUM: Yes, Your Honor. 20 THE COURT: The Court will allow that. 21 Forty-seven, these minutes were not given to 22 Lilly, so there's no notice. The Court is not going 23 to allow that and it's not a final FDA determination 24 under McClintock. 25 Fifty-one, this is Lilly's manual; is that PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 145 1 right? 2 MS. MANGRUM: Yes, Your Honor. 3 THE COURT: The Court will allow only that 4 portion that you have set forth in your response, 5 Mr. Vickery, and redact the balance. 6 MS. MANGRUM: Your Honor, I would just like to 7 point out for the Court that plaintiffs' own experts 8 have testified in this very case that this activity of 9 excluding patients thought to be at high risk of 10 suicide is absolutely appropriate, and in light of 11 that testimony, I'm not -- I don't see how Mr. Vickery 12 can use this to imply Lilly did anything wrong. 13 THE COURT: Mr. Vickery. 14 MR. VICKERY: Your Honor, I expect that 15 tomorrow morning in the opening -- 16 THE COURT: Is that correct, that your experts 17 are going to testify as proffered? 18 MR. VICKERY: Oh, sure. Sure. The problem is 19 that I expect what we'll hear from Mr. See in the 20 morning is something along these lines, Prozac has 21 been the most studied drug in the history of the 22 world. There's been all of these studies, and it's 23 important for me to let the jury understand that in 24 all of these studies that were done, they purposely 25 skewed the scales of the studies by excluding people PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 146 1 for whom the drug would be intended later. 2 MR. SEE: If I might, Your Honor. 3 THE COURT: I thought the drug was intended for 4 people who had depression. 5 MR. VICKERY: It is, but you see, when they did 6 the -- in one of the eight or nine, depending on the 7 point in time, items that a physician is suggested to 8 check off as an indication for Prozac, there's a list 9 and it comes from the DSM-III or now IV. And there 10 are these eight diagnostic criteria and the physician 11 will say, well, do you have this? Yes. Okay, well, 12 how about this? No. This one? Yes. And if he gets 13 four out of the eight, then they say, well, that means 14 Prozac is indicated for that person. 15 Well, one of the eight is suicidal ideation or 16 actions, so they indicated or recommend it for 17 patients who are suicidal, and yet, when they did all 18 of the clinical studies, they excluded those very 19 patients from the study. 20 So it's important for me, as Mr. See touts how 21 much this drug has been studied, to say to the jury, 22 yeah, it was studied all right, but when they studied 23 this, they excluded some of the people that they 24 intended to market it to later. 25 THE COURT: Then why do your experts approve of PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 147 1 that? 2 MR. VICKERY: Of doing that in the clinical 3 study? 4 THE COURT: Yeah. 5 MR. VICKERY: There's nothing wrong with doing 6 it in the clinical study. What's wrong is to come in 7 to this court and try to persuade the jury that this 8 whole issue has been so thoroughly looked at and 9 there's no problem here, when in fact, if you look at 10 the way that it was looked at, and there are many 11 other aspects of that I could go on about, if you look 12 at the way that it was looked at, you see they haven't 13 really studied that phenomenon at all. 14 THE COURT: Mr. See. 15 MR. SEE: If I may, Your Honor, the manual is 16 directed at out-patient studies; that is, people who 17 are out in their normal walk of life. They are not 18 hospitalized. With respect to those patients, my 19 experts at Lilly and FDA and his experts and everybody 20 agrees, if you have a patient at high risk, right 21 then, of suicide, you don't put them in a randomized 22 study where you might be giving them a placebo, 23 because they might walk out and kill themselves. It's 24 very unethical. 25 The way you study patients with high risk of PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 148 1 suicide -- 2 THE COURT: That's Dr. Healy's point, isn't it, 3 as to why a more comprehensive study has not been 4 completed in this case. 5 MR. SEE: Well, I will have some questions for 6 Dr. Healy about that, and some of them will concern 7 in-patient studies; that is, when patients are 8 actually in the hospital under constant supervision, 9 so that, number one, the guns and knives and so on 10 with which they might dispatch themselves are kept 11 from them, and they're watched very, very carefully. 12 With respect to those in-patient studies, in 13 fact, patients at current high risk for suicide are 14 included. I also don't want the Court to have the 15 idea that in out-patient studies, that patients that 16 have suicidal thinking, have been excluded. That's 17 not the case at all. The exclusion is current high 18 risk for suicide. Now, there are people that have 19 suicidal thinking that are not, in fact, at current 20 high risk to actually carry out the act and those 21 patients, in fact, a very large percentage, were in 22 the out-patient studies. 23 So it's really -- it's a red herring. I 24 believe the plaintiffs want to try to use it for 25 inference, as Mr. Vickery just said, that somehow PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 149 1 people who had suicidal thinking were not really 2 studied because of this, and that's not what this 3 says, and it's not what it means and his own experts 4 agree with that. That this is how you study an 5 antidepressant drug, but the high risk suicidal people 6 are studied in in-patient studies. 7 THE COURT: Well, I'll allow it for 8 cross-examination only then. 9 Now, No. 53 -- 10 MS. MANGRUM: Your Honor, if it would save the 11 Court some time, Mr. See and I withdraw our objection 12 and have no objection to the admission of that. 13 THE COURT: Thank you. You get two points, 14 too. 15 MR. SEE: It's now a tie. 16 THE COURT: So 53 is allowed. I wasn't going 17 to allow that one. 18 No. 54, the Court will allow this, but only for 19 notice and not for the truth, and instruct Mr. Vickery 20 to redact anything regarding other injuries. 21 No. 57, the Court is not going to allow that 22 under 402 and 403. 23 Fifty-eight, the Court will allow that. That's 24 a Lilly analysis done by Lilly employees. I note 25 here, Mr. Vickery points out that this is the same PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 150 1 document being offered by Lilly as Exhibit 1115; is 2 that correct? 3 MS. MANGRUM: It was at one time when we 4 simultaneously exchanged, but as Mr. Vickery sees on 5 our list, we have withdrawn that exhibit. 6 THE COURT: Then why are you objecting? 7 MS. MANGRUM: Well, we have withdrawn it 8 because we don't want to offer it. We object to his 9 offering it. It was on -- 10 THE COURT: I'm going to allow it, but it seems 11 like maybe someone has put us through a lot of extra 12 work here. 13 MR. SEE: Your Honor, if I could just say, on 14 our initial exhibit list, it was unknown at the time 15 whether the issue of foreign regulatory events were 16 going to be admitted in the case. On our principal 17 exhibit list, we had zero exhibits about foreign 18 regulatory events. We had a separate little part that 19 said now, if foreign regulatory events are going to be 20 in the case, then there may be these additional 21 exhibits that we might want to put in evidence, and 22 that is the part in which this document appeared. 23 THE COURT: All right. No. 64, the Court's not 24 going to allow that. That's an unsigned letter and 25 the Court's not going to allow it under 402 and 403. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 151 1 And I should say, just because I'm mentioning 402 and 2 403 in some of these rulings, that I applied that in 3 all of the rulings. 4 Sixty-five, I'm not going to allow that under 5 402 and 403. 6 Sixty-eight, the Court's not going to allow 7 that. And a lot of these are getting cumulative, and 8 the Court finds that they would be a waste of time, 9 involve a mini trial. 10 No. 70, the Court's not going to allow that 11 under 402 and 403. 12 Seventy-one, the Court will allow that. This 13 involves an admission by a Lilly employee. 14 MS. MANGRUM: Your Honor, just by way of 15 explanation, this document is discussing the DEN 16 system, which is the Drug Experience Network, a new 17 computer way of tracking adverse events that was set 18 up by Lilly, and I suspect that from Mr. Vickery's 19 note that he plans to use this to show that Lilly had 20 no idea what events were out there and what were not. 21 The truth is -- 22 THE COURT: To show what? 23 MS. MANGRUM: That Lilly didn't know or wasn't 24 keeping close track of medical event reports that it 25 was receiving. This document does not stand for that PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 152 1 proposition at all. Because if DEN was the only 2 system in place at Lilly, I believe he could make that 3 inference, but that is not and was not the case and he 4 makes the remark here at the end of his comment about, 5 "And Lilly claims that they have done comprehensive 6 reporting and meta-analysis of data." 7 The data meta-analysis to which he is 8 referring, makes it clear on the face of that 9 document, that it did not look just at DEN, that it 10 looked at all the case report forms, and made a 11 comprehensive review of the hard documents. Looked at 12 it all. 13 So for him to take this one speculative memo 14 where this employee says, I'm not sure if it went into 15 DEN or not, to imply, number one, that it did not, 16 number two, that that was the only way of tracking 17 medical events, and that therefore, any analysis done 18 of the data was flawed is simply inappropriate. 19 THE COURT: Mr. Vickery. 20 MR. VICKERY: I don't know how in the world she 21 plans on proving those things, Judge, unless she's 22 going to take the stand and testify. The 23 meta-analysis was done by Dr. Charles Beasley who they 24 refuse to bring. I don't know how she anticipates 25 that she's going to prove this to the satisfaction of PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 153 1 the jury, but if she's got somebody that will take the 2 oath and be subject to cross-examination that will 3 explain that this interpretation is wrong, let her do 4 it. 5 MS. MANGRUM: Your Honor, I would say that any 6 expert can rely on medical literature, and this is 7 published medical literature, and in fact, our experts 8 will rely upon it and can read from the face of the 9 document to Mr. Vickery what I've just argued to the 10 Court. 11 THE COURT: All right. Again, I will allow 12 that. 13 Seventy-three, has that -- that appears to have 14 been withdrawn. 15 MR. VICKERY: No, Your Honor. The -- 73, they 16 said -- they objected that it was 27 different memos, 17 and they're correct. It was the form that we got it 18 in and we couldn't tell if that was one document or 19 not, and that's why I was given one exhibit number. 20 What we have done is withdrawn specific pages that 21 reference specific memoranda, and you'll see that 22 there's one, two, three, four, five, six, there are 23 six sequences of pages or memos that we are still 24 seeking to offer. 25 THE COURT: All I'm looking at is in the middle PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 154 1 column under defendant's objections it says, "PZ 2467, 2 291-293." Those are the pages involved and then you 3 have in the middle here, "Withdrawn 291-293." 4 MR. VICKERY: Then I don't know how this list 5 got printed up and given to the Court. The one that I 6 have and the one that I provided to Ms. Mangrum lines 7 up each entry, each page entry on the middle column 8 with our response on the right. So, for example, 9 246 -- 10 THE COURT: Do you have -- I have a top page 11 for Exhibit 73 and it has exhibit withdrawn, and 12 someone has written in, "Portions of exhibit withdrawn 13 as follows, colon," and then there's a list of pages 14 withdrawn, right? 15 MR. VICKERY: Your Honor, I don't know what the 16 Court's reading from. I'm looking at the exhibit list 17 that is the final version that Ms. Mangrum provided. 18 THE COURT: Come take a look. 19 MR. VICKERY: Your Honor, the handwritten page 20 that you're looking at was prepared by Ms. Hall, one 21 of our paralegals. Those are the pages that were 22 withdrawn. The only ones we're still offering are 23 those pages that are right behind it in the Court's 24 copy. 25 THE COURT: Well, the yellow portion on the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 155 1 objections that the Court is being directed to address 2 refers to Pages 291 to 293. 3 MR. VICKERY: Clearly those are withdrawn when 4 I look at Ms. Hall's notes. 5 THE COURT: What I said is correct then? 6 MR. VICKERY: Yes, sir. 7 THE COURT: I'm not often right, so that's nice 8 to hear. 9 MR. VICKERY: Well, you're the judge, sir. 10 THE COURT: Now, as far as on Page 28 at the 11 top there, involving Exhibit 73, the Court will allow 12 Pages 294 through 296 only for notice and not for the 13 truth. And the Court will not allow anything else 14 under 73 under 402 and 403. 15 Now, 74, what's the relevance of this, 16 Mr. Vickery? 17 MR. VICKERY: Well, as I said in the relevance 18 column, Your Honor, the relevance is that it puts 19 Lilly's arguments about FDA stringent regulation in 20 context. It puts it in context. When they -- and we 21 haven't gotten to the FDA documents yet, so I don't 22 know how the Court's going to rule on that, but when 23 they say, we have here this document and it's an FDA 24 document and it shows that this was approved by the 25 FDA, I want to show the jury, this was written by PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 156 1 Lilly. It was written by Lilly and you gave the 2 computer disk to the FDA and they just -- 3 THE COURT: We asked you for a computer disk of 4 the jury instructions, right? 5 MR. VICKERY: That's true. That's true. 6 THE COURT: Does that taint the jury 7 instructions then? 8 MR. VICKERY: I don't think it taints the jury 9 instructions, Your Honor. I don't think it taints 10 them at all. I understand that in the regulatory 11 process sometimes somebody might draft something for 12 the FDA to consider. I do understand that, but it 13 seems to me quite a different thing when Lilly in a 14 case, such as this, hides behind the FDA regulation 15 and tries to create the illusion that it is under such 16 stringent government regulation. And I think anything 17 that I can show the jury to put that in context is 18 important to my case. 19 MS. MANGRUM: Your Honor, I would point out to 20 the Court what I have in several cases already pointed 21 out to Mr. Vickery and that is, 21 CFR Section 22 314.430, which reads, "Before approval of the 23 application, the applicant may prepare a draft summary 24 basis of approval which the Center for Drug Evaluation 25 and Research will review and may revise." I should PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 157 1 think that that should put the issue to rest without 2 having to give it to the jury. 3 THE COURT: I'm not going to allow it under 402 4 and 403. Same with 75. 5 Seventy-six, the Court will allow. 6 Seventy-seven, the Court will not allow. 7 Seventy-eight is a duplicate of Lilly's 8 Exhibit 1053. 9 MS. MANGRUM: This is what we discussed a 10 little earlier, Your Honor. It's -- part of it was 11 plaintiffs' Exhibit No. 1 and Lilly has withdrawn this 12 from its exhibit list. 13 THE COURT: Well, I'm going to allow that to 14 the extent that it shows that the FDA wanted 15 information regarding the foreign regulatory actions 16 and redact the balance. 17 Seventy-nine, the Court will allow. 18 MS. MANGRUM: Would that be, Your Honor, with 19 the redaction of the unidentified handwriting that the 20 plaintiffs produced or is that not on the Court's 21 copy? 22 THE COURT: Yes. Well, let's see. If there is 23 handwriting, then it should be redacted. 24 MR. VICKERY: There is handwriting, Your Honor, 25 and we will redact it. As I pointed out, one of the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 158 1 problems that a lawyer has when they inherit a case 2 from an MDL that other counsel have handled, sometimes 3 you get documents and you don't know what's on them or 4 whose handwriting, but the best we can tell, that 5 handwriting there is from MDL, the plaintiffs' 6 counsel. 7 THE COURT: Or what the original source is. 8 MR. VICKERY: An even greater problem, Your 9 Honor, an even greater problem. 10 THE COURT: Now, the next exhibit, 80, I'm not 11 going to allow. You seem to be wanting to show that 12 for the purpose that Lilly was not telling the BGA 13 about suicidal potential, but as a matter of fact, 14 your immediately preceding exhibit does just that and 15 it was a letter that was written to them two months 16 earlier. 17 MR. VICKERY: Okay. 18 THE COURT: No. 81, the Court is not going to 19 allow that. It's a non-final agency determination and 20 it's under McClintock and 402 and 403, the Court's not 21 going to allow that. 22 No. 83, the Court will not allow that. Again, 23 under 402 and 403. 24 Eighty-four, the Court will not allow that, 25 under 402 and 403 and McClintock. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 159 1 Eighty-six, the Court's not going to allow that 2 under 402 and 403. That may be, possibly, relevant 3 regarding punitive damages and we'll take that up 4 later. 5 Eighty-seven, the Court will not allow that, 6 402 and 403. 7 Eighty-eight, the Court will allow that as far 8 as notice and not for the truth. 9 Eighty-nine, the Court will not allow that. 10 Ninety, the Court will allow. It's a memo from 11 Dr. Beasley. 12 Ninety-one, the Court will allow as admission 13 by Lilly. 14 MS. MANGRUM: Your Honor, on these last two, 90 15 and 91, there's going to be a great factual dispute in 16 this case whether Mr. Forsyth, in fact, had the 17 events -- 18 THE COURT: He what? 19 MS. MANGRUM: There will be evidence from both 20 parties whether, in fact, he experienced the events 21 that are discussed in these documents, and I would ask 22 only that this Court ask Mr. Vickery to put on such 23 evidence and to show, in fact, through his witnesses 24 that these events occurred in Mr. Forsyth before these 25 documents be admitted. Because if he cannot make that PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 160 1 showing, they're evidence of other injuries. 2 THE COURT: What do you have to say to that, 3 Mr. Vickery? 4 MR. VICKERY: Well, I think Ms. Mangrum knows 5 that Dr. Healy's belief is that akathisia happened, 6 and unfortunately, we don't -- we're very limited in 7 the amount of information that we have regarding 8 Mr. Forsyth, you know, he's not here and those that 9 had an opportunity to observe him -- I mean, for 10 example, Dr. Roberts himself never observed the man on 11 Prozac. He gave it to him on February 22nd, talked to 12 him on February 23rd, he was 200 percent better. 13 Talked to him the next day and he wanted to go to the 14 hospital. So the sources of information there are 15 very limited so what we're left with is expert opinion 16 about what probably happened. 17 So they know quite well what the foundation is, 18 that the expert opinion that comes in is that this man 19 probably experienced these phenomenon. 20 Before Mr. See speaks to this, I want to ask if 21 I'm going to be double-teamed all afternoon on 22 exhibits? 23 THE COURT: Mr. See. 24 MR. SEE: Your Honor, the request is simply a 25 foundation. The plaintiff ought to lay a preliminary PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 161 1 foundation because we know a great deal, in fact, 2 about what people observed. Most of the time 3 Mr. Forsyth was taking Prozac he was in Castle Medical 4 Center under constant observation. We also had the 5 testimony of his son, the plaintiff, Mr. Forsyth, who 6 has testified unequivocally that at the time he 7 observed his father, for example, after he came out of 8 the hospital, he was calm. He was sedate. He was not 9 fidgeting. He was not pacing. He was not wringing 10 his hands. 11 The factual predicate for a diagnosis or even 12 an inference that this man had akathisia is simply not 13 present in the case. I understand and I know 14 Dr. Healy will give an opinion that he had akathisia, 15 but the fact is Dr. Healy never saw Mr. Forsyth. 16 Dr. Healy cannot divine that Mr. Forsyth had akathisia 17 from medical records because there's not a single 18 medical record that he ever had akathisia. 19 Dr. Neal who supervised him in Castle said 20 absolutely, the man was under close supervision, and 21 he never had akathisia, never had symptoms of 22 akathisia. So the factual predicate to make these 23 documents relevant simply won't be there, and all, I 24 guess, we're asking is, the plaintiff ought to have to 25 make that factual predicate to show that the documents PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 162 1 will be relevant because at least if the testimony is 2 going to come as the discovery did and as the records 3 show, there aren't going to be any factual underlying 4 predicate that the man had akathisia. 5 THE COURT: Do you intend to introduce this 6 with Dr. Healy's testimony, is that it? 7 MR. VICKERY: I intend to discuss it with him, 8 yes, I do, Your Honor. 9 THE COURT: Then I'll make my determination at 10 that time then. 11 MR. VICKERY: Okay. 12 THE COURT: Ninety-three, the Court's not going 13 to allow that under 402 and 403. 14 Ninety-four, the Court will allow that. 15 MS. MANGRUM: Your Honor, in this regard -- 16 THE COURT: As far as any hearsay, that will 17 only be for the notice and not for the truth. 18 Ninety-five, this was -- how do you pronounce 19 this name? Teicher. 20 MR. VICKERY: Teicher. 21 THE COURT: Teicher. I guess I'll be hearing a 22 lot of that. 23 MR. VICKERY: And, Your Honor, I will tell you 24 before you rule on this one, of course, it's only 25 offered for notice, but there is a stipulation now PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 163 1 that's been signed by both counsel that Lilly was 2 aware of this article in February of 1990. That is a 3 stipulated item that they were aware of. 4 THE COURT: Well, it's included in their 5 marketing instructions -- 6 MR. VICKERY: Right. 7 THE COURT: -- and also in their letters to 8 doctors, they go through an analysis of the study. 9 Anyway, it's only being admitted -- it's only being 10 offered for notice; is that right? 11 MR. VICKERY: Right. 12 THE COURT: So the Court will allow it for that 13 purpose and not for the truth of it. 14 No. 96, again, notice only and not for the 15 truth. 16 Ninety-seven, the Court will allow that, and 17 the same with 98. 18 Ninety-nine, the Court will not allow. 19 MS. MANGRUM: Your Honor -- 20 THE COURT: Through 402 and 403. Yes. 21 MS. MANGRUM: On 95, before we get too much 22 further, that is to be allowed in cross-examination as 23 notice, am I correct? Because -- 24 THE COURT: Correct. 25 MS. MANGRUM: -- it is not admitted as an PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 164 1 exhibit. 2 THE COURT: Correct. 3 MS. MANGRUM: Thank you. 4 MR. VICKERY: Now, wait a minute, Judge. They 5 stipulated that Lilly was aware of this document in 6 1990, and how I get hamstrung on this, you'll just let 7 him use that in cross-examination, won't you? And the 8 only guy they're going to be bringing, the Lilly guy 9 is -- 10 THE COURT: Dr. Tollefson. 11 MR. VICKERY: -- Dr. Tollefson who didn't even 12 arrive on the scene until -- well, they may bring 13 Dr. Thompson, I don't know. I can't get an answer on 14 that issue. 15 THE COURT: I thought you said he was going to 16 be their key witness? 17 MR. VICKERY: Dr. Thompson? 18 THE COURT: Correct. 19 MR. VICKERY: Leigh Thompson? I don't know, 20 they can tell you whether or not they're going to be 21 bringing him. I'd like to know myself. 22 MS. MANGRUM: Your Honor, that's a question we 23 won't be able to answer until we see the state of 24 Mr. Vickery's case when it's concluded. 25 MR. VICKERY: You see what happens to me? They PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 165 1 say, you can only use this document to cross-examine 2 someone, and then the only guy they may choose to 3 bring is this guy that didn't show up until 1991. 4 THE COURT: If Dr. Healy relied on it as an 5 expert, he can testify to it. 6 MR. VICKERY: Okay. I just want the jury to 7 have this document. Since Lilly stipulated that they 8 were aware of the document, I want the jury to have 9 this document. 10 MS. MANGRUM: Your Honor, Dr. Healy can testify 11 about it all he wants. Under 803-18, medical articles 12 are not admissible into evidence. 13 THE COURT: Let's see, how far did I get? 14 MR. VICKERY: You got down to -- 15 THE COURT: Ninety-nine. 16 MR. VICKERY: -- ninety-nine. 17 THE COURT: I said I was not going to allow 18 that. One hundred, the Court's not going to allow 19 that under 402 and 403. The same with 101. 20 102, the Court will permit that. Again, that's 21 only as to notice, and again, remind me whenever you 22 want a limiting instruction. 23 103, the Court will permit that. 24 104, the Court will permit that. 25 MS. MANGRUM: Your Honor, on Exhibit 103, this PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 166 1 is a draft and there's no evidence that this letter 2 was ever sent out to anyone. 3 THE COURT: It says a Lilly response to anyone. 4 MS. MANGRUM: Right, and the document says 5 across the front of it, "Draft, Draft B," and it's 6 unsigned and there's no evidence that this went 7 anywhere. 8 THE COURT: It has as much as the same verbiage 9 as your dear-doctor letter, doesn't it? 10 MS. MANGRUM: Well, it's discussing bulimia and 11 other injuries, and I just -- you know, what Lilly 12 writes in a draft form and who drafted it, you know, 13 it could have been a medical assistant or someone. I 14 just don't know that, so there's no evidence that it 15 went to anyone. 16 THE COURT: Then why was the person's name 17 blocked out? 18 MS. MANGRUM: Because this was who Lilly was 19 responding to. Mr. Vickery has it listed incorrectly. 20 This was sent from Lilly's research laboratories to 21 someone outside and under FDA regulations when you're 22 responding to a request about drug experience reports 23 under the conditions of the MDL protective order, 24 those were redacted, so the person to whom it was sent 25 or intended to be sent when it got finished, is PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 167 1 redacted and then the signature is for someone from 2 Lilly and no one had ever signed it. 3 THE COURT: Mr. Vickery. 4 MR. VICKERY: It's a draft. It doesn't matter, 5 Your Honor. It's still a Lilly admission. It's 6 drafted by someone at Lilly. I don't have control 7 over their final documents. If this letter was 8 superseded by some other letter, then all they have to 9 do is produce it and say, Mr. Vickery, here's the 10 final version that went out. And I'll say, well, 11 let's substitute it, but they have control over that 12 evidence, I don't. 13 All I do is inherit from the MDL certain 14 documents and here's a letter they got, Exhibit 102 15 and 103, and here's the response they drafted. In the 16 absence of other information, I have to assume that 17 someone at Lilly thought this was an appropriate 18 response. Now, whether it was ever sent or not, you 19 know, they can develop or not. 20 THE COURT: Well, isn't this all covered in the 21 dear-doctor letter and other letters you have? I 22 mean, even the letter to Dr. Riggs, it's almost word 23 for word if you read it. 24 MR. VICKERY: It is almost word for word. The 25 timing of this letter is important to me, Judge. You PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 168 1 see the Teicher -- 2 THE COURT: This is three years before the 3 incident that we're talking about. 4 MR. VICKERY: Yes, I understand that, but this 5 is right at that point in time in which the issue of 6 Fluoxetine-induced suicidality was a live or hot 7 issue, if you will, from a public and regulatory 8 standpoint. So that's what this -- the timing of this 9 letter, even though I agree with you, the verbiage is 10 very similar to what was sent out later, that is 11 something that is important to me. 12 THE COURT: Well, I'm going to allow that. And 13 104 I said I would allow also. 14 105, I will not allow, non-final determination, 15 402, 403, and McClintock. 16 106, the Court will permit. 17 107, the Court will allow, but any reference to 18 Oraflex should be redacted. 19 MS. MANGRUM: Your Honor, just to clarify, on 20 exhibits that we were going through, has your 21 instruction been, if they contain other injuries, such 22 as 106 talking about -- 23 THE COURT: Yes, if there are any other 24 injuries, they should be redacted. I said that at the 25 beginning. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 169 1 108, I'm not going to allow that. It's a 2 non-final determination of the FDA, Mr. McClintock. 3 109, the Court will permit. 4 110, the Court will permit that. 5 112, the Court will allow this for 6 cross-examination purposes. Again, this will be only 7 for notice and not for the truth. 8 113, the Court will permit that. 9 114, the Court is not going to allow that under 10 402 and 403 and McClintock. 11 115, I take it this would only be for 12 cross-examination or reliance? 13 MR. VICKERY: Yes, Your Honor. 14 THE COURT: The Court will allow it for those 15 purposes. 16 116, the Court will permit, but there should be 17 some redaction. 18 MR. VICKERY: Your Honor, that one was 19 difficult for us because it appears from the context 20 of what was said that the margin A in this instance, 21 was not made by counsel in the MDL, but by Lilly 22 people. I'd have to pull it if you want me to discuss 23 it in detail. I'll take that back, Judge. 24 THE COURT: It doesn't add anything anyway. 25 MR. VICKERY: You're right. I'm sorry. I'm PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 170 1 trying to do too many things too fast. We'll redact 2 it. 3 THE COURT: 117, the Court will permit that as 4 an admission. 5 118, same. 6 119, this is an article by Dr. Healy that he 7 would like to rely on, is that it? 8 MR. VICKERY: Yes, I would like to use it to 9 cross-examine the defendant's experts. 10 THE COURT: Pardon me? 11 MR. VICKERY: Yes, Your Honor, and I want to 12 use it under 803-18 to cross their people. 13 THE COURT: You may do so. 14 120, the Court is not going to permit that as a 15 non-final determination under McClintock and 402 and 16 403. This is an internal FDA memo that was not given 17 to Lilly, so it's not notice. 18 121, the Court will permit that, but only for 19 notice and not for the truth. 20 122 -- 21 MR. SEE: Your Honor, if I may? On 121, it 22 does concern akathisia, and I wonder if 121 can come 23 in the same category as the previous exhibits we 24 discussed where if, in fact, there's a factual 25 predicate for akathisia and Dr. Healy has the facts to PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 171 1 rely upon, only then can it be used. 2 THE COURT: Well, yes. If akathisia does not 3 seem to be relevant, then I won't allow it in. 4 I think I ruled on 122, did I not? 5 MR. VICKERY: No, you did not, Your Honor. 6 THE COURT: I thought I did, but I guess it 7 wasn't a favorable ruling for you. Anyway, I'm not 8 going to allow that. Non-final FDA determination 9 under McClintock, 402, and 403. Again, that was an 10 internal FDA document that was not given to Lilly. 11 No. 123, the Court will not allow that under 12 402 and 403. 13 MR. VICKERY: May I cross-examine Dr. Thompson 14 on it, Your Honor? 15 THE COURT: Yes, if he's here. 16 MR. VICKERY: I don't suspect he will be, 17 Judge. 18 THE COURT: And again, the same thing with 124, 19 you may cross-examine him on that, but otherwise, it's 20 not admissible. 21 125, the Court's not going to allow that under 22 402 and 403. 23 126, article by Dr. Healy, so I guess you want 24 to use that for reliance on cross-examination? 25 MR. VICKERY: Yes, I do. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 172 1 THE COURT: Well, you may use it for that 2 purpose. 3 127, a transcript of the FDA advisory 4 committee. The Court is not going to allow that under 5 402 and 403. 6 128 and 129, if the door's opened, the Court 7 will allow those letters if Dr. Healy is being 8 discredited. 9 MR. SEE: Your Honor, may I ask for a point of 10 clarification? It had never been and will not be the 11 intent of questioning Dr. Healy to try to impeach him 12 on bias or on some improper motivation. What will be 13 the thrust of the cross-examination will be that his 14 science is bad. 15 THE COURT: That what? 16 MR. SEE: That his science is bad. I'm 17 presuming and, I guess, asking for the Court for 18 direction, if we can have it, that that doesn't open 19 the door. 20 THE COURT: Well, it would seem to me that one 21 way or the other it's going to come out that at one 22 point he was hired by or had some relationship with 23 Lilly. 24 MR. SEE: As with the objection to the 25 exhibits, I would interpose an objection to that PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 173 1 question because this: Lilly is not attacking 2 Dr. Healy on the fact that he's not qualified, on the 3 fact that he's biased, on the fact that he had some 4 improper motivation. The only thrust of the 5 cross-examination of Dr. Healy is that on this topic, 6 his science is just not good. 7 THE COURT: And what was the topic that Lilly 8 wanted to hire him for and did hire him? 9 MR. SEE: Lilly went and asked him what he 10 thought about akathisia and Fluoxetine. And it is 11 revealing -- I will tell the Court what he said. When 12 Lilly did hire him and had a meeting with him. He 13 said, well, what I would tell my residents is, when 14 you take Fluoxetine, it's just like you feel when you 15 have a couple extra cups of coffee. That was his 16 testimony. That's what he told Lilly. Now, he has 17 said something very different now that he's gotten 18 involved with the litigation. 19 THE COURT: Well, if you limit your examination 20 to what you just stated, then the Court will be 21 inclined not to rule that the door's been opened. 22 MR. SEE: Thank you. 23 THE COURT: 130, the Court will allow. 24 131, I take it this is for reliance and 25 cross-examination? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 174 1 MR. VICKERY: Yes, it is. 2 THE COURT: It will be allowed for that 3 purpose. 4 MS. MANGRUM: Your Honor, pardon me for being 5 slow to object. On 130, I would like to raise one 6 point. This is just the reply points to Oswald, 7 Healy, and Creaney. This document was apparently 8 authored in the U.K. and that is clear from the 9 spelling of certain words in it. They spelled them in 10 the British way. We have no idea or cannot determine 11 who wrote it, who prepared it, who it was by. There 12 is a final published version of this letter in the 13 published literature, but for that reason, I would 14 object to there being no foundation, because we have 15 no idea who prepared it, who drafted it, and what 16 their experience level was, and if in fact, it was 17 part of their job to do this sort of a reply. 18 THE COURT: This says it's a draft of a Beasley 19 response. 20 MS. MANGRUM: Well, that's what Mr. Vickery had 21 said. This obviously isn't authored by Charles 22 Beasley because of the spellings in it as I pointed 23 out. For example, in Paragraph 2, line four, the word 24 randomized is spelled with an S as the British do not 25 with a Z as we do. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 175 1 The final article that was in the published 2 medical literature is by Charles Beasley, this 3 however, is not as far as we can determine. It's by 4 someone in the U.K. where this issue arose where 5 Dr. Healy lives. 6 MR. VICKERY: That's the reason I said when I 7 described it, "Draft of Beasley Response," Your Honor. 8 When -- this is a draft. When Lilly finalized and 9 published a response in the medical article, it was 10 signed by Dr. Charles Beasley, so whether Dr. Beasley 11 did this draft or whether he had some minion do this 12 draft for him, this was done by or for Dr. Charles 13 Beasley at Lilly. 14 THE COURT: Well, how does this differ from the 15 final article? 16 MR. VICKERY: You've asked me something that I 17 just can't answer without going and looking at them. 18 MS. MANGRUM: It differs a great deal, Your 19 Honor. If the Court would like, I can provide a copy 20 of the final published version from the British 21 Medical Journal. 22 THE COURT: Are you suggesting that this was 23 prepared by someone other than a Lilly employee? 24 MS. MANGRUM: No. I'm suggesting that it was 25 prepared in the United Kingdom by someone at Lilly, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 176 1 but someone whose experience and knowledge and the 2 foundation for these statements I have no evidence nor 3 does Mr. Vickery. 4 THE COURT: But you're saying it was prepared 5 by a Lilly employee? 6 MS. MANGRUM: I believe it was, a Lilly 7 subsidiary employee. 8 THE COURT: I'm going to allow it. 9 139, the Court is not going to allow under 402 10 and 403. 11 148, the Court is not going to allow under 12 McClintock, non-final agency determination, 402, 403. 13 It wasn't sent to Lilly so they didn't have notice of 14 it. 15 150, the Court is not going to allow this under 16 402 and 403. Frankly, it doesn't appear misleading to 17 the Court anyway. 18 151, the Court will not allow under 402, 403. 19 It doesn't appear relevant. 20 153, I take it -- 21 MR. VICKERY: I'm sorry, Your Honor. 151, this 22 lady is going to be testifying, Amy Lee. This is a 23 note of a conversation she had with Dr. Riggs Roberts. 24 They're both going to be testifying. 25 MS. MANGRUM: Your Honor, if I might? Her name PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 177 1 appears on this document. She did not prepare this 2 document. She is listed as the Dista sales 3 representative who called on Dr. Roberts. That was 4 true up until February 15 -- 5 THE COURT: You mean, representative of Lilly? 6 MS. MANGRUM: Yes. But she did not make this 7 call. Her name is listed just because she was 8 Dr. Roberts' sales representative, the last one who 9 called on him. She last called on him sometime toward 10 the end of 1992. She was no longer employed by Lilly 11 as of February 15, 1993, but she was identified on 12 there as the Lilly sales rep, as she was the last one 13 who called on him at the time this call was made. 14 She was no longer in Lilly's employ at the time 15 of the Forsyths' deaths. 16 THE COURT: This first page of 151, was a 17 telephone message? Sales rep, Amy Lee, and then 18 someone's written in "suicide, violent behavior." 19 What does that all mean? 20 MR. VICKERY: I don't know. That's what I want 21 to ask Amy Lee about. That's the reason she's under 22 subpoena to be here, Your Honor. 23 THE COURT: Well, what's your guesstimate? 24 Does it involve this case at all? 25 MR. VICKERY: I think so. I think it does PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 178 1 involve this case. 2 THE COURT: Why? 3 MR. VICKERY: The date. 4 THE COURT: Where is the date? 5 MR. VICKERY: It's on the third line, 3/10/93. 6 THE COURT: Okay. Maybe we can decipher that. 7 So where was she? Was she on Maui or what? 8 MR. VICKERY: She was their -- I'm sorry, 9 something that Ms. Mangrum said just registered with 10 me, Judge. Let me simply hold off -- 11 THE COURT: What is this meant to be? Is this 12 meant to be a call to the doctor, Dr. Riggs or what? 13 MR. VICKERY: I think it's meant to reflect a 14 telephone conversation between Dr. Riggs -- Dr. Riggs 15 Roberts and a Lilly personnel. 16 THE COURT: So Dr. Roberts called her and said 17 Mr. Forsyth just stabbed his wife and committed 18 suicide? 19 MR. VICKERY: Right. 20 THE COURT: Well, what's the relevance of that 21 to this trial? And what is this that follows here 22 anyway? 23 MR. VICKERY: I don't know because I haven't 24 talked to the woman, Your Honor. I haven't talked to 25 the sales rep. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 179 1 THE COURT: It says, "Prepared by M. Williams." 2 Who's that? 3 MR. VICKERY: I have no idea. 4 THE COURT: Does that have anything to do with 5 this case? 6 MR. VICKERY: I believe that this is a report 7 that was prepared by Lilly in the wake of this case. 8 This particular document, though, as I look at it, 9 particularly given what -- 10 THE COURT: It says, "Released on 3 March." 11 MR. VICKERY: Right. Particularly given what 12 Ms. Mangrum just said about when Ms. Lee left the 13 employ of Lilly, I just want to back down and withdraw 14 it. 15 THE COURT: Pardon me? 16 MR. VICKERY: I'd like to just back down and 17 withdraw it and sit down gracefully. 18 THE COURT: What is that? 19 MR. VICKERY: That's 151. 20 THE COURT: Okay. 151 is withdrawn. 21 MR. VICKERY: Right. 22 THE COURT: Good. Let's take a break. Let's 23 take a 15-minute break. 24 (Whereupon, a recess was taken at 3:00 p.m.) 25 THE COURT: So did we leave off with 153? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 180 1 MR. VICKERY: Yes, Your Honor. 2 THE COURT: And that will be for reliance and 3 cross-examination. 4 155, same. 5 161, the Court will allow that. 6 165, the Court's already ruled on that. Have 7 you reached agreement on the number of photographs? 8 MR. VICKERY: Yes, we have, Your Honor. 9 MR. SEE: We have, Your Honor. We've agreed on 10 that. 11 THE COURT: Okay. 167, is there an objection 12 there? 13 MR. SEE: There is, Your Honor. What 167 is, 14 is about a 15 or 20 or so minute, around in there, 15 video of excerpts from many videotapes taken over the 16 years, and I made some notes as I looked at it and it 17 is several video sets of different occasions when 18 various members of the Forsyth extended family 19 gathered together; on the boat with the grandchildren, 20 the grandchildren opening up presents at Christmastime 21 and so on. 22 I really have only two points to make about it. 23 Number one, a great deal of the video, as it is, has 24 been excerpted and put together in this summary 25 fashion is strictly concerned with the children of PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 181 1 Bill Forsyth, Jr.; that is, the grandchildren of 2 Mr. and Mrs. Forsyth. Now, clearly they are very cute 3 and handsome children. Those children are not, 4 however, plaintiffs in the case nor are they 5 beneficiaries under the Hawaii wrongful death statute. 6 Those beneficiaries are William, Jr. and Susan 7 Forsyth. 8 And it's my view in looking at this video it 9 concentrates extraordinarily on these grandchildren, 10 and in this case where we're operating under a 11 statutory scheme where we know who the beneficiaries 12 are and we know the prescribed elements of damage, the 13 grandchildren involvement is simply an appeal to 14 sympathy, very charming and very cute children, but 15 they are people who cannot take under the statute and 16 cannot be beneficiaries under this lawsuit. 17 And so both under 402, being not relevant, and 18 403 being unduly prejudicial our objection is to the 19 inclusion of all of these scenes of the grandchildren, 20 and there are some scenes where it's just the 21 grandchildren and the grandparents aren't even around, 22 at least that the camera could see. So that would be 23 one objection. 24 The other objection is, as the video has been 25 edited, and I don't know where this was put in, but it PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 182 1 sort of ends with a boat ride and there's soft music 2 in the background and so on. It's a little much of a 3 production, if I can say so. So I object to the way, 4 especially with the background music, it's kind of a 5 boat sailing off into the sunset sort of thing. 6 I think it's probably legitimate to show family 7 life so that the jurors can understand about the 8 relationship of Mr. Forsyth, Jr. and Ms. Forsyth with 9 their parents, but I think the grandchildren 10 involvement, and particularly the heavy emphasis on 11 it, is an appeal to undue and improper sympathy, and 12 so I object to it on that basis. 13 THE COURT: Mr. Vickery. 14 MR. VICKERY: Your Honor, I think all of those 15 concerns can readily be handled by an instruction from 16 the Court. I'm sure if Mr. See would draft one, I 17 would agree that the Court should give it, explaining 18 that the grandchildren are not takers under the Hawaii 19 wrongful death act, but certainly, when you take 20 people's -- I mean, the Forsyths are no different 21 probably from any of our other families, when they're 22 rolling the cameras for home videos, people seem to 23 focus on the little ones. 24 THE COURT: But you have been doing a lot of 25 editing. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 183 1 MR. VICKERY: Well, I didn't do the editing. 2 Until he just said that to me just now or he just said 3 it to the Court and I heard it, that was not -- it was 4 certainly not our purpose, and I didn't think it was 5 our impression. My instruction -- I didn't do the 6 editing, but my instructions were, let's select from 7 the videotapes 15 or 20 minutes that will help the 8 jury see what kind of family this is, what kind of 9 family relationships there were, so that's what we 10 have tried to do. 11 We've not tried to appeal to sympathy. We 12 don't want these people's sympathy. And we've not 13 tried to focus on the grandchildren. I mean, I agree 14 with Mr. See when he -- there's a photo or two of -- 15 in the family photos that are being offered, the still 16 photographs, of Mr. or Mrs. Forsyth with 17 grandchildren, and Mr. See raised that issue with me 18 and I said, Mr. See, I agree totally with you that 19 they're not takers, but that doesn't mean that a 20 photograph of someone with their grandchildren is not 21 probative of what the children have lost. 22 I can assure the Court that a picture of my 23 mother and my child is indicative of the kind of love 24 and affection that I have with my mother, and I expect 25 that the same is true for the Court and for most human PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 184 1 beings. So it is probative evidence. It's very 2 relevant evidence, and this whole concern about 3 grandchildren can be cured entirely with an 4 appropriate instruction. 5 THE COURT: Frankly, I would have thought that 6 both of you would have been discussing more about the 7 fact that Lilly is asserting that there's marital 8 discord, that the Forsyths were very depressed, that 9 there were a number of other reasons why Mr. Forsyth 10 may have committed suicide and that these photographs 11 would go toward either rebutting or presumably 12 rebutting that. 13 MR. VICKERY: Had he raised a relevance 14 objection, I would have done that, Your Honor, because 15 I think that's true. As I understood the objection 16 Mr. See made, it's not irrelevant, but a 403 17 objection. In other words, he's saying, I know this 18 is relevant evidence, but I think that having photos 19 of the grandchildren -- 20 THE COURT: If they are just of the 21 grandchildren, they do seem to be irrelevant. 22 MR. VICKERY: But it shows Mr. Forsyth with the 23 grandchildren. So had he said that it's simply not 24 relevant, I guess I would have said -- 25 THE COURT: He said there are some of just the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 185 1 grandchildren alone. 2 MR. SEE: There's some opening presents and so 3 on at Christmas. 4 THE COURT: Can you fast forward it or 5 something through that, through those phases? 6 MR. VICKERY: Sure. Sure, we can do that. But 7 what I would submit to the Court is that even there, 8 you know, if it's a family setting, and if, for 9 example, Bill, Jr. is on the stand, say, were your 10 parents there when the kids opened their presents? I 11 mean, did they make it a point after they moved here 12 on Maui to be close to you and their grandkids, were 13 they there? 14 It is indicative not only of the loss that 15 Bill, Jr. suffered from the death of his parents, but 16 also the other items the Court mentioned, the nature 17 of the family relationship and whether, indeed, it's 18 true as Lilly says, that this man had such a horrible 19 marriage and horrible family circumstances and that's 20 what caused him to murder his wife and kill himself. 21 MR. SEE: With respect, Your Honor, these 22 videos, as best I can look at them, because of the 23 physical appearance of all of the people in the family 24 do change a little bit, were taken over a period of 25 some years. Mr. Forsyth was only in a deep depression PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 186 1 from December of '92 until the end of his life. 2 So in terms of whether the video could rebut 3 that, they simply don't go to it because they weren't 4 taken in that period of time. And I believe the 5 relevancy objection is raised and the irrelevancy goes 6 to the fact that the children aren't plaintiffs, and 7 can't take under the statute. 8 I mean, I look at it and I think to myself, 9 well, is a juror going to sit there and think, those 10 poor little grandchildren. And that's just not a 11 proper amount or kind of damage in this case. 12 THE COURT: Well, I tend to agree with some of 13 that and I'd like the two of you to get together to 14 see if you can revise the video or fast forward it or 15 something to procure that problem. 16 MR. VICKERY: All right. We'll endeavor to do 17 that. 18 THE COURT: And the same thing goes for 168. 19 MR. SEE: We have spoken and I have indicated 20 to Mr. Vickery which of the photographs that I have a 21 problem with, and they are, essentially, all those 22 that are of the grandchildren. There are a number of 23 the grandchildren. There are other photographs, June, 24 Mrs. Forsyth, Senior, and her father, for example. 25 Again, there are some photographs that just PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 187 1 aren't relevant to any issue in the case, kinds of 2 damages or anything like that, so we will get together 3 on that, Your Honor. 4 THE COURT: All right. I'm going to allow 170 5 and 172, but again, with respect to 172, redacting 6 pictures drawn by the grandchildren. 7 Now, on 173, there are a number of objections 8 relating to -- as I take it, this was a phone call or, 9 I guess, a transcript of a phone call that Lilly made 10 to a number of doctors, and these are responses by the 11 doctors. They reflect responses of one doctor saying 12 "Injuries, they are so hyper that they could not sit 13 still." Another, "Inability to concentrate, work, or 14 carry on conversations; decreased attention span." 15 Another, "Amphetamine like action, severe anxiety, and 16 the feeling of wanting to jump out of own skin. 17 Insomnia, bopping other people on the head in the 18 unit, or something. Irritability, feeling wired." 19 You seem to want to say something about that, 20 Ms. Mangrum. 21 MS. MANGRUM: I haven't decided what yet, Your 22 Honor. I was waiting for you to finish. 23 THE COURT: Okay. Well, in that case, I'll 24 allow them, but only for putting Lilly on notice and 25 not for the truth of the matter. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 188 1 MS. MANGRUM: Your Honor, in that regard, you 2 said during the course of the hearing today, if there 3 were certain matters to which we believe that a 4 limiting instruction applied, we should identify those 5 to the Court. 6 THE COURT: Pardon me? 7 MS. MANGRUM: I believe that you stated earlier 8 that to the extent that the parties sought a limiting 9 instruction concerning the use of drug experience 10 reports or anecdotal reports of medical events, that 11 they cannot be used to show causation, that we should 12 let the Court know. Do you wish us to prepare a 13 pleading in that regard, or what would be the Court's 14 pleasure? 15 THE COURT: Didn't you actually already prepare 16 a joint instruction on that? 17 MS. MANGRUM: Yes. We have an instruction, but 18 we haven't totally agreed. 19 THE COURT: Oh. 20 MS. MANGRUM: We've submitted both parties, but 21 to the extent that we would like the final product to 22 apply to exhibits that we've reviewed today, how 23 should we let the Court know that? 24 THE COURT: Well, by communicating with the 25 Court. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 189 1 MS. MANGRUM: Any special form? Should I just 2 write a letter or call Ryan or prepare a pleading. 3 THE COURT: It shouldn't be done ex parte, but 4 you should put something in writing as far as which 5 exhibits you want a limiting instruction for, or if 6 during the trial itself, if something has come up 7 where you feel there should be a limiting instruction, 8 ask for a side bar. 9 MR. SEE: Your Honor, if I may? 173 is one of 10 those sets of exhibits that concerns lots of different 11 kinds of adverse events. 12 THE COURT: Yeah, it would just be limited to 13 what I just read off, which is what, you know, the 14 hyperactivity. 15 MR. SEE: Yes, sir. 16 THE COURT: Also, I wanted to ask you about -- 17 I've read a lot of statistics and whatnot during the 18 course of going over these exhibits, but is there a 19 study that indicates, as far as people who are 20 suffering from a depression and commit suicide, is 21 there a study as to what percentage of those people 22 have akathisia? 23 MR. SEE: Gosh, what percentage of the 24 population overall had akathisia? 25 THE COURT: What percentage of depressed PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 190 1 people, people that you know have been depressed, and 2 then they commit suicide, what percentage of those 3 people had akathisia? 4 MR. SEE: I can't tell you that as I stand 5 here. I don't know that off the top of my head. Of 6 all the depressed people who commit suicide, how many 7 of those also had akathisia? I don't know that as I 8 stand here. 9 THE COURT: I would think that would be -- if 10 there is such a study, that that would be rather 11 significant. 12 MR. SEE: The thing is depression is a very 13 commonplace. Suicide, unfortunately, is a little bit 14 less commonplace, but still very common, while people 15 that actually have akathisia are very rare. So I 16 don't know of a study that actually looks to those 17 elements in combination. There may be one, but I 18 don't know. 19 THE COURT: What is your definition of 20 akathisia? 21 MR. SEE: Akathisia has been defined in the 22 DSM-IV, which is the psychiatrist's manual for 23 diagnosing psychiatric problems, it contains two 24 elements. One element is a subjective feeling of 25 restlessness and one of four specific items that are PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 191 1 enumerated. So you have to have the subjective 2 feeling of restlessness and you have to have one or 3 more of the four items. And the four items are in the 4 nature of having an inability to sit or stand still, 5 being in constant movement, rocking back and forth -- 6 I'm trying to remember exactly what the others are, 7 but it's a motor -- it is a motor -- oh, I know. 8 Having restless legs. People will tap their legs like 9 that (indicating) and also pacing. 10 THE COURT: I see a lot of people like that. 11 MR. SEE: This is involuntary. It goes on and 12 on and on, and apparently, it's quite an uncomfortable 13 feeling. Those are the diagnostic criteria for 14 akathisia in the DSM-IV. 15 THE COURT: Thank you. 16 MR. SEE: If I could ask one more for 17 clarification, Your Honor? Your Honor has said with 18 respect to some of the exhibits that contain adverse 19 events about which the parties are in disagreement 20 whether there will be a factual predicate, that 21 perhaps the plaintiffs need to make sure that factual 22 predicate is laid before, for example, they would 23 bring up such an exhibit with Dr. Healy, and I believe 24 173 would be in that category. 25 THE COURT: I think so, yes. I think that's PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 192 1 correct. 2 MR. SEE: Very well. Thank you. 3 THE COURT: 174, I had a question mark. I 4 guess the question mark is it refers to Lilly's 5 response to number four, and the objection here by the 6 defendant seems confused or makes me confused anyway. 7 MS. MANGRUM: Our response or our objection -- 8 THE COURT: It says, "In addition, there's no 9 admission nor denial to this request, simply a 10 reference to Lilly's response to number four." 11 MS. MANGRUM: That's correct, Your Honor. On 12 this one, I believe that the easiest way to handle it 13 would be to have the request number three, the 14 response is in number four, since it's incorporated by 15 reference in response to number three. So you would 16 have to have the request number three, the substantive 17 response to number four to make this combination work, 18 and our objection to that would be, again, that the 19 predicate -- the factual predicate that needs to be 20 laid before this could be admitted. 21 THE COURT: You follow all that, Mr. Vickery? 22 MR. VICKERY: I sure didn't, Judge. 23 THE COURT: I didn't either. 24 MR. VICKERY: I think she said she wants me to 25 read three and four both, but she wants me to try half PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 193 1 of my lawsuit first. 2 THE COURT: I'm not sure that we have number 3 four. Well -- 4 MS. MANGRUM: My objection to number three is 5 there's no response to it. All it says is look at 6 number four. So if all he wants to read is number 7 three and read to the jury, "Look at number four," 8 that's all he's designated. He's designated, "See 9 general objections, 2, 3, and 11 subject to and 10 without waiving objections, Lilly incorporates herein 11 by reference response to number four." By his 12 designation, that's all he could read. 13 THE COURT: Number four says, "Look at 14 Dr. Thompson's testimony and ventures." 15 MS. MANGRUM: No, number four says, "Lilly 16 states that while Fluoxetine is neither sedating nor 17 activating antidepressant, a minority of Fluoxetine 18 patients in Lilly's double-blind placebo 19 controlled" -- 20 THE COURT: No, you're reading from something I 21 don't have. 22 MR. VICKERY: I see the problem. There's two 23 sets. There's two sets for request for admission and 24 what Ms. Mangrum was just looking at was the first 25 set. If you see in Exhibit 174, it's the response to PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 194 1 the second set. What the Court was looking at, what 2 we've offered is request number three of the second 3 set. It's on Page 7, Ms. Mangrum, of the second set 4 of responses. 5 MS. MANGRUM: The problem with this is -- 6 MR. VICKERY: The request was -- excuse me, if 7 I may. The request was to admit that Lilly cannot 8 explain how Prozac works either for treatment of 9 depression or for other behavioral disorders, and it's 10 the response to that -- the admission and response to 11 that one that we were offering. 12 MS. MANGRUM: My difficulty here has been that 13 what is labeled as the exhibit and what was produced 14 as the exhibit are different, so my foresight -- 15 THE COURT: Well, why don't you two get 16 together later on and see if you can straighten this 17 out, and if you can't, then come back to me. 18 MR. VICKERY: Okay. 19 THE COURT: So I guess the next one is 175, 20 response to Interrogatory No. 57. This goes back to 21 the one that Mr. See was speaking to earlier, I guess, 22 the exclusion of people with serious suicidal risk 23 from the controlled trials. 24 MR. VICKERY: That's the issue. 25 THE COURT: Now, that I'm going to let PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 195 1 Mr. Vickery question Dr. Healy on as to whether that's 2 appropriate or not. 3 MR. SEE: I believe the -- part of the 4 substance of the objection was, Your Honor, was there 5 are a lot of controlled clinical trials, there were a 6 lot, for depression. So asking what are the exclusion 7 criteria, some of them had different ones. It's like 8 a compound question. It's hard to give the response. 9 THE COURT: Well, I think that ought to be 10 explained anyway. It's not something that you're 11 trying to hide, is it? 12 MR. SEE: Not a bit. 13 THE COURT: I think that ought to be explained. 14 MR. VICKERY: Well, Your Honor, I think, as I 15 suggested, in the offer, it could easily be cured with 16 a stipulation, that in the clinical trials for 17 depression, one of the exclusion criteria was people 18 were at serious suicidal risk. That's what the 19 interrogatory answer says, and if Mr. See just wants 20 to stipulate to that, then we can avoid all of that. 21 MR. SEE: It's hard to do that because it's not 22 accurate. 23 MR. VICKERY: Well, his sworn interrogatory 24 answer says that, though, Judge. It says, "Lilly 25 further states that the following were exclusion PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 196 1 criteria for the controlled trials for depression. 2 Serious suicidal risk," it's right there on Page 28 of 3 their interrogatory answers. 4 MR. SEE: That was the exclusion criteria for 5 outpatient studies. It was not an exclusion criteria 6 for inpatient studies. 7 THE COURT: Well, why don't you prepare a 8 stipulation to the -- to cover what you just stated, 9 Mr. See, and see if Mr. Vickery will agree to that? 10 MR. SEE: All right, sir. 11 THE COURT: I trust that neither of you are 12 trying to keep anything from the jury on that, so... 13 No. 14, the Court will allow. This is a 14 response to Interrogatory No. 14, the Court will allow 15 for notice and not for the truth of the matter. 16 Now, I guess we get to Page 90 and I think all 17 of the matters from there on pertain to the punitive 18 damages phase, if we get there, so I don't think we 19 should take the time to go through those today. 20 I ought to turn to the plaintiffs or the 21 defendants exhibits and the objections to them. 22 Ryan, you better go get the -- the first one, 23 1008, trying to decipher what's been written here 24 under defendant's response to plaintiffs' objections. 25 It says, "No objections to the medical records in this PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 197 1 exhibit, which were produced by Dr. Brady. However, 2 there are documents in this exhibit that" -- this was 3 defendant's exhibit, I take it. Defendant is saying 4 there are documents in this exhibit which are not 5 Dr. Brady's medical records and Lilly objects to them. 6 MS. MANGRUM: I can explain that, Your Honor. 7 Mr. Vickery has said counsel has been conferred and 8 agreed that plaintiffs' version will be admitted and 9 defendant's response is referring to what plaintiffs 10 have produced, which is different than the documents 11 that we received pursuant to discovery on the firm. 12 THE COURT: Which exhibit of plaintiffs is 13 that? I don't recall. In any event, is there any 14 problem with eliminating the pages that Lilly objects 15 to, Mr. Vickery? 16 MR. VICKERY: I'm not sure which ones they are, 17 Your Honor. 18 THE COURT: Pardon me? 19 MR. VICKERY: I'm not sure which pages they are 20 that they object to. 21 THE COURT: Okay. I want you two to get 22 together and go over that. 23 MR. VICKERY: Okay. 24 THE COURT: 1009, defendants state that 25 plaintiffs have not listed Castle Medical Center PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 198 1 records as an exhibit. 2 MR. VICKERY: Judge, all I can tell you is this 3 was their exhibit list. This left-hand column, 4 exhibit description. I didn't make up the 5 descriptions they gave these exhibits, they did. 6 MS. MANGRUM: Well, I'm saying here, it says, 7 we're going to use yours, and I'm just saying, we 8 can't use yours because you haven't listed any. 9 MR. VICKERY: I'm sorry, we put the label on 10 Dr. Neal's records, okay? They are one in the same 11 records. The records are marked as plaintiffs' 12 exhibits. I'm sorry, we called them Dr. Neal's 13 instead of Castle's. 14 THE COURT: Well, 1003 you do make reference 15 to -- or the defendants, I guess, make reference to 16 Dr. Neal's medical records. Anyway, you two get 17 together and resolve that. 18 MR. VICKERY: Okay. 19 THE COURT: 1020 and all the ones that -- the 20 Court is going to allow the records that refer to 21 Mrs. Forsyth being prescribed Prozac. That falls 22 within the ruling made by Magistrate Judge Yamashita 23 and goes to her psychiatric and mental history. 24 So same for 1021. 25 The Court will allow 1022. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 199 1 The Court will allow 1023, but redact 2 everything that doesn't relate to depression. 3 And the same with 1024. 4 1025, our copy really is not legible. Do you 5 have a copy for the jury that they can read? 6 MS. MANGRUM: Yes, Your Honor. 7 MR. SEE: Your Honor, at the page marked 019 8 down at the bottom right-hand corner, the copies are 9 very bad, that is absolutely true, but there are 10 legible parts to that which show that when 11 Mrs. Forsyth was treated here at Saint John's Hospital 12 she had a test for depression, and really the point of 13 it was to show that back in various times of her life 14 she was having these recurring bouts of depression. 15 So at least that part is legible. 16 THE COURT: Well, I can't -- I'm not sure that 17 meets -- is that the form that they use? I mean, it 18 looks like a form. Oh, this is better than what we 19 have. 20 Okay. I will allow that. 21 1028, the Court will allow that. Same with 22 1040. 23 Now, we have a bunch of questionnaires, I 24 guess, of acquaintances of the Forsyths who were asked 25 all sorts of questions about their condition before PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 200 1 their deaths. 2 MR. SEE: Your Honor, we have withdrawn those. 3 We would reserve the right to use them for 4 impeachment, but will not be offering them. That's 5 143, 144, and 145. 6 THE COURT: Right. Okay. 7 MR. SEE: I believe the Plaintiffs also 8 withdrew the similar questionnaires on their list as 9 exhibits to be offered in evidence. 10 THE COURT: All right. 1047, the Court will 11 allow that, but order that non-indicated uses be 12 redacted. 13 MR. SEE: If I could just state for a point of 14 clarification, when Lilly submitted safety data to 15 FDA, and particularly this submission, it submitted 16 data on gathering adverse events from the studies 17 conducted no matter what indications the study was 18 conducted for, but it all became safety data. In 19 other words, the safety data from the bulimia study 20 don't have anything to do with bulimia at all. We 21 gave Prozac to this many people and here's the adverse 22 events we saw. 23 I understand the Court's ruling and we will do 24 that, but I do believe the safety side is very 25 different than studies show is or is not a good drug PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 201 1 to treat bulimia. 2 THE COURT: What's your point then? 3 MR. SEE: Well, I guess my point is we'll 4 redact the non-indicated uses, Your Honor. Thank you. 5 THE COURT: Okay. 1049, the Court will allow 6 this because it's a final action by the FDA under the 7 McClintock responding to citizens' requests, I guess 8 is what you call it, to acquire a different label and 9 there are several of those. 10 1050, Mr. See, maybe you better speak to that. 11 MR. SEE: Your Honor, 1050 is simply a blank 12 case report form that is a document that consists of a 13 number of forms used to fill out the different sorts 14 of examinations and testing of a patient as they go 15 through a clinical trial. In all candor, we may not 16 use any bit of this at all. We listed it on the list 17 in case, how clinical trials get conducted, what 18 happens, how often does the patient go in to see the 19 doctor, what does the doctor do, and that sort of 20 thing. If that comes in to issue, we would have a 21 document to refer to. 22 In all candor, that would not be offered as it 23 is and if any parts will be referred to, I don't know. 24 That's the reason it is on the list. It is in blank. 25 It doesn't contain any data at all. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 202 1 THE COURT: Why don't we bring it up if you 2 decide to use it? 3 MR. SEE: Yes, sir. 4 THE COURT: 1055, the Court is not going to 5 allow under 402 and 403. It's not a final 6 determination under McClintock. 7 Same with 1058. 8 MR. SEE: Now, Your Honor, if I could speak to 9 1058. 1058 has to do with a fact, not an agency 10 determination. It's not a matter of wanting to put in 11 a document and saying that the FDA thinks Prozac is 12 great or anything like that. But basically, it refers 13 to a very specific fact; that is, a telephone call 14 between Dr. Wernicke of Lilly and FDA, where 15 Dr. Wernicke informed FDA of certain events that were 16 going on in Germany; namely, what was going on with 17 the German regulatory agencies. 18 So this document is not put in to show any kind 19 of interim agency action or anything great about 20 Prozac, but only that this conversation occurred. 21 It's a very narrow fact. 22 THE COURT: This is a letter from Lilly to the 23 FDA? 24 MR. SEE: No, it's an FDA memo. It's an 25 internal FDA memo that reflects that this conversation PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 203 1 took place. It has to do with whether Lilly provided 2 information to FDA. 3 THE COURT: I thought that you had a letter 4 that laid down for the FDA exactly what requirements 5 would be made by every other nation. 6 MR. SEE: We did, Your Honor. I mean, we do. 7 This letter goes to a very specific fact. I believe 8 that the plaintiffs in their case will suggest that 9 when the BGA made inquiry to Lilly during the German 10 approval process, that Lilly was not forthcoming and 11 did not tell the FDA that all of this was going on, 12 and this letter goes to the fact that Lilly, in fact, 13 did tell the FDA. 14 THE COURT: Well, again, I thought this other 15 letter lays out in detail what all the other nations 16 have required. 17 MR. SEE: In fact, it does, Your Honor. It is 18 a timing question. You know, I believe Mr. Vickery 19 will suggest to the jury that during particular times, 20 Lilly was misleading or not forthcoming, not giving 21 the FDA full information and this letter shows that it 22 was. It's not a letter. It's an internal memo. 23 THE COURT: But what's the difference in timing 24 between that and the other one that I'm referring to? 25 MS. MANGRUM: It's October 26th to PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 204 1 December 3rd, and then approval finally was had on 2 December 29th of the same year. This is just closer 3 to the time of approval. 4 MR. SEE: The point being -- 5 THE COURT: I thought that was the letter that 6 I mentioned earlier. 7 MS. MANGRUM: October 26th, right, 1987. And 8 that's on our list. 9 THE COURT: On your list or is it -- I think 10 there was one -- 11 MS. MANGRUM: Actually, it's on both of our 12 lists. 13 THE COURT: So you're talking about two months 14 difference? 15 MS. MANGRUM: Yes. 16 THE COURT: And the other one being earlier? 17 MS. MANGRUM: Actually -- yes, the other one is 18 earlier. 19 THE COURT: This is cumulative anyway. 20 MR. SEE: Well, all I can say, Your Honor, is, 21 you know, I believe that the plaintiffs are going to 22 make the suggestion that Lilly was not forthcoming. 23 THE COURT: You have a letter -- as I 24 understand it, you have a letter in October of this 25 very same year laying out all of the German PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 205 1 requirements two months earlier than this. 2 MS. MANGRUM: It's just been our experience in 3 the past in this litigation, Your Honor, that this 4 argument is made. If that argument is not made, we 5 fully have always argued that, in fact, the Court's 6 position that the October 26th letter in detail sets 7 out all of Lilly's foreign regulatory activity. 8 The plaintiffs in other cases have claimed 9 that, in fact, Lilly did not -- was not forthcoming in 10 that regard and this is additional evidence that Lilly 11 was forthcoming. To the extent that's not an issue, 12 we would have no need for this December 3, 1987 memo. 13 MR. SEE: Your Honor, we can certainly defer 14 and bring it up at the time if the issue is raised 15 that would make Exhibit 1058 particularly relevant. 16 We can certainly do that. 17 THE COURT: All right. Let's defer it. The 18 Court is not going to allow 1059 in furtherance of its 19 in limine ruling. 20 MS. MANGRUM: Your Honor, if I might clarify 21 this. I think Mr. Vickery has made a mistake in his 22 objection. 23 THE COURT: I know that bulimia is indicated if 24 that's what you're going to say. 25 MS. MANGRUM: No. Mr. Vickery's objection says PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 206 1 that these are from weight loss studies or from 2 obesity studies or bulimia studies. In fact, if you 3 look at Table -- Attachment 2 that he wants to keep 4 out of evidence, it refers to three trials, HCAC, 5 HCAF, and HCCP, and each one of those trials is a 6 controlled clinical trial in depression. These are 7 not from any studies other than depression. The issue 8 raised was, do patients on Prozac, as an adverse 9 event, tend to lose weight? Is that a problem with 10 the drug? And Lilly looked at these three depression 11 trials and evaluated the adverse event of weight loss 12 for the FDA and that's what this is. It's nothing to 13 do with clinical trials in indications other than 14 depression. 15 THE COURT: What's this got to do with this 16 trial? 17 MS. MANGRUM: In the FDA's approvable letter 18 that the Court has found admissible, they say Lilly, 19 please tell us -- we see these things as potential 20 problems, please respond to them for us. And this is 21 our response showing that we provided that information 22 to the FDA. 23 THE COURT: About losing weight? 24 MS. MANGRUM: Well, there's two. One is, I 25 believe, anxiety or agitation and Table 2 is weight PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 207 1 loss. It's just to make the complete response that we 2 made to the FDA in response to the September 9th 3 letter. 4 THE COURT: All right. The Court will allow 5 that. 6 1061, the Court will allow this. It's a final 7 statement by the FDA under McClintock. 8 1067, isn't this cumulative of 1061? 9 MR. SEE: Well, Your Honor, it is about the 10 same event, but 1067 is the FDA's release to the 11 public about its decision on that event and contains 12 some different language in it. It simply is the FDA's 13 public announcement about its final decision on the 14 event that is referred to in 1061. 15 THE COURT: Okay. The Court will allow that. 16 1068, this is an advisory committee 17 recommendation of the FDA, which seems to be not 18 admissible under McClintock. 19 MR. SEE: If I could speak to that, Your Honor? 20 THE COURT: Yes. 21 MR. SEE: The FDA's advisory committees are 22 bodies created by regulation that are bodies of 23 independent experts brought together, yes, to advise 24 the FDA on specific questions submitted to it. The 25 pharmaceutical drugs advisory committee, which is the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 208 1 one we're concerned with here, this press release, 2 which is the FDA's press release, advises the public 3 about the determination of that independent body. It 4 does not tell the public about a regulatory decision 5 because, in fact, Your Honor, as a result of this 6 decision by the advisory committee, the FDA made no 7 regulatory decision. They decided that everything was 8 okay, because there are a lot of people that said take 9 Prozac off the market. It's terrible and so on. 10 The advisory committee met, had a public 11 meeting under regulation, it's all set out in the CFR, 12 issued its final decision. Yes, by law, it's advisory 13 on the FDA, that's correct, but the advisory 14 committees themselves exist as independent bodies. 15 They are not part of the FDA, and their decision as 16 reflected in the FDA press release was their final 17 decision answering the questions submitted to it by 18 the FDA, and as a result of that, the FDA took no 19 regulatory action. So I would submit that this press 20 release reports a final decision by the pharmaceutical 21 drugs advisory committee. 22 THE COURT: Well, what if the FDA took some 23 action? 24 MR. SEE: If the FDA took some action, I 25 would -- in order to be consistent and what I honestly PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 209 1 believe, the decision of the advisory committee on -- 2 the FDA submits a question. Is there credible 3 scientific evidence that Prozac causes suicide or 4 violence? That's submitted to this advisory body, and 5 they come back and answer it and they say, no, there 6 is no such evidence. 7 Now, if the FDA came down and said, well, we 8 think we're going to do something anyway and here's 9 what we do. I believe what the FDA did is the final 10 decision of that regulatory agency, but I also believe 11 that what the advisory committee did as it exists as 12 an independent body under the regulations is also a 13 final decision. It's a final decision of a different 14 body. 15 THE COURT: I mean, at the very end of it it 16 says, "Although advisory committee recommendations are 17 not binding on the agency, they are given careful 18 consideration in any decisions that the FDA makes." 19 MR. SEE: That's absolutely correct, but, Your 20 Honor, the important distinction is, this advisory 21 committee is not a bunch of FDA employees or FDA 22 scientists or FDA bureaucrats or whatever who are 23 making -- having their internal memos and one 24 disagrees with the other one until it finally gets to 25 the top and there's a decision. That's not the case PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 210 1 with the advisory committee. It is brought together. 2 It is submitted a question. It has a public open 3 meeting and it makes its decision and it answers the 4 question. What the FDA chooses to do with that 5 question, is a totally separate issue. 6 THE COURT: Mr. Vickery. 7 MR. VICKERY: This is that sauce for the goose 8 sauce for the gander item the Court mentioned when you 9 came in. A decision to admit this document which is a 10 rank hearsay would be totally inconsistent with the 11 Court's numerous rulings already citing the McClintock 12 case, which I'm red faced for not citing to the Court 13 earlier myself, that a non-final agency decision 14 should not be admitted. The Court, in every ruling 15 you have made, had been absolutely consistent with 16 that principle including the Sanford Block, Exhibit 61 17 and 67. It would be inconsistent with that principle 18 to admit this. 19 Mr. See says this is a -- his response in the 20 response column is, this is a public document, so he 21 wants to get around hearsay by saying this is an FDA 22 document, but then he runs into a little McClintock 23 problem and a problem with consistency with the 24 Court's other rulings and so says, well, get me over 25 the hearsay loop, Judge, by saying it's a government PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 211 1 document, but then as soon as I get over that hurdle, 2 then let me say, oh, it's not really a government 3 document. It's this independent body. I can go on 4 and on about the independence of the body, but that's 5 yet another tale, Your Honor. It is rank hearsay and 6 to admit it would be inconsistent with the Court's 7 other rulings. 8 MR. SEE: If I could, Your Honor? 9 Mr. Vickery's only objection was hearsay and the 10 document is not hearsay because it's authenticated 11 with the red seal and the whole works, but -- although 12 he didn't make the non-final decision objection, I 13 never heard him say that the advisory committee does 14 not, was not created or does not exist as an 15 independent body, legally independent of the FDA. 16 It's not part of the agency. The people that serve on 17 that body are not FDA employees. 18 THE COURT: Okay. I'm not going to allow it at 19 this time. If you can give me some authority to the 20 contrary, I'll reconsider that. 21 MR. SEE: Very good. We'll do that, Judge. 22 THE COURT: No. 1074 -- and that may also cause 23 me to reverse some of my rulings with respect to the 24 plaintiffs' exhibits, too. 25 No. 1074, the Court will permit this. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 212 1 1075, I have a question mark. 2 MR. SEE: Your Honor, 1075 -- 3 THE COURT: 1075 is kind of duplicative of 4 1074, isn't it? 5 MR. SEE: It just comes from a different place. 6 1074 comes from the Food and Drug Administration -- 7 THE COURT: No, this is that -- 8 MR. SEE: 1075 comes from the World Health 9 Organization. They say the same things, but they're 10 from different sources. 11 THE COURT: Who are they? I've never heard of 12 them. 13 MR. SEE: The World Health Organization? 14 THE COURT: Right. 15 MR. SEE: It's the body of the United Nations. 16 THE COURT: Are they entitled to as much 17 consideration as the BGA? 18 MR. SEE: The WHO is not a regulatory body. 19 They don't approve or disapprove medications. It's a 20 scientific body. It's basically a scientific advisory 21 body to the United Nations. 22 THE COURT: What's your position, Mr. Vickery? 23 MR. VICKERY: My position, Your Honor, is that 24 it is a hearsay document, however, given the Court's 25 ruling on 1074, overruling my hearsay objection, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 213 1 consistency wise, this doesn't add anything, but, you 2 know, having overruled me on 1074, it wouldn't 3 surprise me if you overruled me on 1075. 4 THE COURT: All right. I'll allow it. Thank 5 you. 6 1077, this is for demonstrative purposes. I 7 don't see why the Court should not allow that. 8 Same with 1084 and 1085, 1091, 1101. 9 Now, 1102, the Court will allow that, but it 10 would seem that if you -- if it covers non-depression 11 patients, then that should be redacted. 12 MR. SEE: It can be, Your Honor. These were -- 13 these are controlled clinical trials that specifically 14 analyzed suicidality, that had actual measurements in 15 the study to see if suicidality got better, got worse, 16 didn't change, and they were conducted in different 17 patient populations. 18 Absolutely, we can redact the ones that were 19 non-depressed. I mean, the only thing I would, just 20 to clarify for the Court -- the plaintiff is saying if 21 you give Prozac to people, it causes them to become 22 suicidal or become violent. And whether you give it 23 to someone who happens to be suffering from depression 24 or from bulimia or from obsessive compulsive disorder 25 or whatever, if it doesn't cause them to become PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 214 1 suicidal or become violent and there are actual 2 measuring devices within studies to gather data in a 3 scientifically valid way about suicidality, that would 4 seem to me to be relevant. I mean, for consistency 5 sake, we can certainly take out the non-depressed 6 studies. 7 THE COURT: Okay. Thank you. 1104 the Court 8 will allow that. 9 1113, the Court will allow that. 10 MR. SEE: I beg your pardon, Your Honor? I 11 missed the number. 12 THE COURT: 1113, the Court will allow. 13 1114, the Court will allow, although it would 14 seem that these are 64 or 94 pages ought to be 15 redacted. I think you can tell -- you know, you can 16 indicate somehow in the exhibit that it consisted of 17 700 pages. 18 MS. MANGRUM: The purpose for that, Your Honor, 19 is just that it shows the portion of the BGA's inquiry 20 that was direct to the suicide issue, that there were 21 many other issues and to the extent -- 22 THE COURT: Isn't there a summary page, too, or 23 something on that? 24 MS. MANGRUM: I'll look at that, Your Honor, 25 and try to pare that down. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 215 1 THE COURT: I think the summary pages are 2 2779 -- I mean 932 and 933. Unless you want the jury 3 to deliberate the rest of the year. There's going to 4 be a lot of reading material here for them. 5 MR. SEE: As I understood, Your Honor, it may 6 be something that we could show them, but then what 7 actually goes in evidence is just a few pages? 8 THE COURT: Yes. 9 MR. SEE: Very good. 10 THE COURT: 1117, isn't that the same as 1114? 11 MS. MANGRUM: It's the same except for the 12 cover page, Your Honor, that says Exhibit G, that's 13 just showing that it was part of Lilly's annual report 14 for Prozac in 1984. The substance on the pages is 15 identical. The PZ or Bates number on the side are 16 different and that one first page that says Exhibit G 17 is different. I believe that's all. 18 THE COURT: So that's to show that it went both 19 to the BGA and the FDA? 20 MS. MANGRUM: Yes, Your Honor. 21 THE COURT: Okay. I'll allow that for that 22 purpose, but again, it would seem that you could trim 23 that down to eight or so pages. 24 1121, that's for the punitive damages phase, so 25 I won't take that up now. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 216 1 1123, the Court will allow that. 2 The Court will allow 1125. That was a final 3 ruling by the FDA under McClintock. 4 1126 -- 5 MR. SEE: Your Honor, I think our computer went 6 a little off on that one. 1126 is, in fact, the 7 citizen's petition that was denied in 1125. 1126 is 8 the request. 1125 is the denial. 9 MR. VICKERY: I'm going to withdraw the 10 objection to it, Judge. 11 THE COURT: You're withdrawing the objection? 12 MR. VICKERY: I'll withdraw the objection to 13 it. Sure will. 14 THE COURT: Always makes you wonder when 15 counsel withdraws his objection. 16 MR. VICKERY: I did it to make Mr. See wonder, 17 Your Honor. 18 THE COURT: I think that covers everything. 19 Any objections that I should have addressed that I 20 haven't. It's only 4:25. 21 MR. VICKERY: I don't think so, Your Honor. I 22 want to thank the Court. I think this will, 23 hopefully, expedite the trial. I don't know, perhaps 24 I should ask, given the Court's ruling, would it 25 expedite matters if we simply made our offer of PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 217 1 exhibits at the inception of the trial consistent with 2 the rulings the Court has made? 3 In other words, everything that's in is in and 4 we move it along. 5 THE COURT: Well, there are some that still 6 require further foundation. 7 MR. VICKERY: I understand. And we would make 8 the offer consistent with the rulings the Court's 9 made. In other words, things that you said, I'm going 10 to allow, those would be the things that we would 11 offer up front and get them in and we need not delay 12 the Court or jury further. 13 THE COURT: Mr. See. 14 MR. SEE: Well, if I understand correctly, what 15 Mr. Vickery is really referring to is what he can show 16 the jury in his opening statement. 17 THE COURT: Pardon me? 18 MR. SEE: Is what he can show the jury in his 19 opening statement, I believe that's really the import 20 of the discussion. 21 MR. VICKERY: That's not the only import. 22 That's certainly one of them, as I told Mr. See. 23 THE COURT: I think that's another issue as to 24 whether they come in before or after your opening 25 statement. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 218 1 MR. VICKERY: That's one of the reasons, Your 2 Honor, but I was really speaking more to the concern 3 about expediting the trial. The Court has spent 4 considerable time and resources in focusing on these 5 exhibits and making the rulings, and I'm merely 6 suggesting that having done that, those that you've 7 clearly ruled are in, it would seem to me to be 8 expeditious for us to say we offer the following 9 exhibits consistent with the Court's ruling at the 10 pretrial, boom, and then we offer the following 11 exhibits for the purpose of notice. 12 THE COURT: That's what I thought you had in 13 mind until Mr. See mentioned opening statements, 14 but -- because it would seem to me that these would be 15 coming in after your opening statements. 16 MR. VICKERY: Right. The opening statement is 17 a whole separate issue there, and I had visited with 18 the Court's clerk about that and was instructed to 19 tell Mr. See those that we anticipated using in the 20 opening statement, which I will do. I've deferred 21 doing that until I had the Court's ruling this 22 afternoon, but certainly -- 23 THE COURT: Anticipating using what? 24 MR. VICKERY: Using in the opening statement, 25 the exhibits that we would anticipate using in the PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 219 1 opening statement. I was instructed by Ms. Miwa, that 2 the Court generally allows that, but that I should 3 disclose to Mr. See beforehand what I intended to use. 4 So I had waited until the Court ruled, so I would know 5 which ones were in and not in. But it's my intent to 6 tell Mr. See that, you know, with respect to these 7 exhibits that the Court has already ruled on, it is my 8 intention to use them in the opening statement. 9 THE COURT: Well, opening statements are not 10 meant to be arguments either. 11 MR. VICKERY: I understand that. They are 12 meant to be an overview of the evidence, Your Honor, 13 and that's one of the reasons I think it would be 14 helpful to use those exhibits. It will keep me on a 15 short leash and keep me from saying something I 16 shouldn't and getting into trouble with the Court. 17 MR. SEE: It has always been my experience, 18 Your Honor, that even if there is a block offer of 19 exhibits, it happens, essentially, after the trial 20 starts; that is, after the opening statements. I just 21 haven't had the experience where actual exhibits, 22 which technically have not yet been admitted, have 23 been used extensively in opening statements. 24 THE COURT: Well, which way do you -- you ought 25 to agree on this one way or the other. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 220 1 MR. SEE: I told Mr. Vickery I plan to make a 2 time line and use one demonstrative exhibit that he 3 knows about and he agrees to and that's it. That is 4 my plan. I just think that if the exhibits have not 5 technically been admitted, then it's probably not 6 appropriate to be using them in the opening statement. 7 THE COURT: Well, I think you're technically 8 correct. 9 How long is your opening statement going to be, 10 Mr. See? 11 MR. SEE: Well, I thought it might be just a 12 little bit over an hour. 13 THE COURT: And how about you, Mr. Vickery? 14 MR. VICKERY: I want however much time Mr. See 15 takes, Your Honor. 16 THE COURT: Pardon me? 17 MR. VICKERY: I want whatever time Mr. See 18 takes. He's paring it down. When we talked about it 19 the other day, he said -- 20 THE COURT: You're going to be going first. 21 MR. VICKERY: I know. 22 THE COURT: He may end up taking half the time 23 you do. 24 MR. VICKERY: I doubt that. The other day he 25 said he was thinking an hour and a half, so it sounds PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 221 1 like he's widdled it down to an hour. 2 THE COURT: I hope our local jurors are going 3 to be able to hold their attention for that long a 4 period of time. 5 MR. VICKERY: I hope so, too, Your Honor. I 6 think if we could have about an hour and 15 minutes 7 apiece, that would enable us to get the jury in and to 8 finish by noon. 9 One of the reasons that I wanted to use the 10 documents in the opening statement is because since 11 the Court clearly will admonish the jury that what the 12 lawyers say is not evidence, that this might be a way 13 to focus them on the evidence when I say it's going to 14 be, and this is a complex case, it's going to take 15 multi weeks, and I think, hopefully if I've done my 16 job properly, by doing this, I will provide them a 17 good overview of the evidence as it will come in in 18 the case. 19 THE COURT: You have any objection to that, 20 Mr. See? 21 MR. SEE: I do. 22 THE COURT: Okay. I think you better just 23 describe what the evidence is going to be without 24 using the exhibits. 25 MR. VICKERY: I will do that, Your Honor. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 222 1 It -- with respect, I submit it certainly is 2 inconsiderate of our jury. 3 THE COURT: Pardon me? 4 MR. VICKERY: I think it is -- the reason that 5 I want to do this is because I think it would be 6 considerate of the jury to give them an opportunity 7 ahead of time to see some of these exhibits and see 8 what they look like and put it in the context of the 9 overall -- 10 THE COURT: They're not going to see what they 11 look like when you hold up a piece of paper. 12 MR. VICKERY: This TV screen right here. 13 THE COURT: Oh. 14 MR. VICKERY: It would be right there on the TV 15 screen, so if I was here, they will angle that out at 16 a 45-degree angle and we can say that there are some 17 exhibits. You'll have an opportunity to look at the 18 entire exhibit later, but to help you to get oriented 19 with the case, particularly the chronology, we're 20 going to show you eight or nine in the course of the 21 time that the Court's allotted us. That's what I 22 really urge the Court to allow us to do. 23 THE COURT: And you're going to be using a 24 demonstrative chart or something? 25 MR. SEE: It is simply the diagnostic criteria PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 223 1 for depression. 2 MR. VICKERY: Which is one of his exhibits. 3 MR. SEE: I won't even use it. I can write it 4 on the tablet. It was just for ease of showing them 5 what they are. 6 MR. VICKERY: You see, Judge. I can do the 7 same thing. I can write the key words from these 8 exhibits on a tablet as well, but isn't it better 9 rather than -- particularly, once you've seen my 10 penmanship, but rather for me to write something on a 11 tablet, just to say, look folks, you're going to have 12 an opportunity to see it. These are government 13 exhibits here. One, take a look at it. I just can't 14 see where the harm is possibly and I would urge the 15 Court to let us do it. Basically, I've prepared 16 around the expectation of doing it. 17 THE COURT: How many exhibits? 18 MR. VICKERY: I think there are eight or nine. 19 Let's see. There are eight, Your Honor. 20 MR. SEE: Again, Your Honor, I just think it is 21 not appropriate because the exhibits have not yet been 22 received into evidence. There's no context. 23 THE COURT: I'm going to agree with Mr. See on 24 that. Anything else we should take up now? 25 MR. SEE: Just one very small item, Your Honor. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 224 1 The parties have, in fact, agreed on a fact 2 stipulation, stipulated to certain things and they are 3 not terribly earth shaking things, but we have agreed 4 on some. I anticipate Mr. Vickery may want to read 5 some of those stipulations to the jury, and I have no 6 problem with that with the exception of stipulation 7 number one. 8 We put down in writing, in essence, what Your 9 Honor asked Mr. Vickery; that is, that Prozac is an 10 unavoidably, unsafe product under the restatement. We 11 formally stipulated to that. I would object if 12 Mr. Vickery plans to read that to the jury because 13 that is a term of art. It's a legal term and a lay 14 jury is not in a position to know or understand what 15 that means. There will be no instruction from the 16 Court. It's telling the jury about a technical, legal 17 term. 18 I mean, frankly, unavoidably, unsafe to a lay 19 person sounds pretty bad, but in fact, it has a 20 particular legal term of art meaning, and it only goes 21 to the legal significance of how that product should 22 be treated. And it really is not a term for the jury 23 so I would object to Mr. Vickery reading that 24 stipulation, number one. 25 THE COURT: Well, it would be read in at some PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 225 1 point, right? 2 MR. SEE: I don't think so, Your Honor. I 3 think that under the Court's instructions, as I 4 believe the Court will give to the jury, product 5 defect will be defined. 6 THE COURT: But they're going to have to know 7 about the stipulation at some point in time before 8 they get the jury instructions, right? 9 MR. SEE: I don't believe so, Your Honor. I 10 believe that Mr. Vickery's agreement -- 11 THE COURT: Well, certainly I would expect that 12 probably some of the experts will be referring to 13 that. 14 MR. SEE: I don't see why, Your Honor. It's a 15 legal consideration. Mr. Vickery's agreement to the 16 Court's answer is Prozac is an unavoidably, unsafe 17 product, and now our stipulation that that, in fact, 18 is the legal effect of Prozac status, what that does 19 is that controls how the Court instructs the jury. It 20 controls what the jury tells -- what the Court tells 21 the jury about what the law means. 22 THE COURT: Well, maybe what you should be 23 doing instead of stipulating is agreeing to an 24 instruction that will be given to the jury. 25 MR. SEE: I would be happy to do that. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 226 1 MR. VICKERY: I guess he would, Judge. He 2 pleads that it's unavoidably unsafe. The Court asked 3 me the other day, Mr. Vickery, are you going to 4 stipulate that this drug is unavoidably unsafe? I 5 said, of course, I will, Your Honor, if Lilly is, but 6 he can't stipulate that it's unavoidably unsafe and 7 then withhold that information from the jury. 8 MR. SEE: The ramification -- 9 MR. VICKERY: Excuse me, Counsel, the 10 ramifications depends on the instructions the Court 11 gives. So certainly when a stipulation is read, 12 either at that time or later, the Court can say, 13 there's certain consequences to some of these 14 stipulations and the Court will give you instructions 15 regarding those consequences and you're to accept the 16 Court's instructions, but a stipulation is a 17 stipulation. Mr. See and his client cannot have it 18 both ways. 19 MR. SEE: May I have it, please, sir, so I can 20 read it to the Court so the Court can know what it 21 says? 22 MR. VICKERY: Sure. 23 MR. SEE: The first stipulation says that 24 Prozac is a, quote, an unavoidably, unsafe product, 25 closed quote, as that term is used in Comment K to PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 227 1 Section 402A, the restatement second of torts. It is 2 to that we've stipulated. 3 THE COURT: It seems to me that really ought to 4 be incorporated into a jury instruction that you both 5 agree to. 6 MR. SEE: I believe that the legal effect of 7 that should be incorporated into a jury instruction, 8 but I do not believe that the jury, neither now knows, 9 or ought to know or ought to be told about anything 10 about 402A. They don't know what that is. Or 11 restatement second of torts. They don't know what 12 that is. 13 What they need to know is what does it mean 14 that a product is defective? Well, I believe under 15 the law with a prescription drug that is unavoidably 16 unsafe, it means that the product, if it doesn't have 17 a manufactured defect, and there's no claim of that 18 here, the product has to be -- has to contain a 19 warning to the doctor of the risks inherit in the use 20 of the product of which the doctor knew or which the 21 company knew or should have known. 22 That's the language that the jury can 23 understand. That's language that lay people can 24 appreciate. As opposed to telling them about Section 25 402A of the restatement. I simply believe that lay PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 228 1 juries, they don't know what that means. It's a term 2 of art. 3 THE COURT: I agree. Anything else? 4 MR. SEE: Only to say -- I'm sorry. 5 MR. VICKERY: Go right ahead. 6 MR. SEE: Only to say, Your Honor, that I 7 understand that the Court and its clerk has worked 8 long and hard on ruling on these objections and I want 9 to express our appreciation. I do believe it will 10 make the trial much smoother and I really do 11 appreciate the Court's hard work on it. 12 THE COURT: Well, thank you. I hope it does 13 facilitate the course of the trial. I guess, we're 14 starting a day later, so you won't be through to next 15 Saturday. 16 MR. VICKERY: Your Honor, the only thing, at 17 the risk of trying the Court's patience with me, 18 having invested the kind of time that the Court has in 19 the exhibits and the multifarious objections from 20 Lilly, and having spent that time and you've ruled, 21 would you please reconsider and let me use eight 22 exhibits in the opening statement that you've already 23 ruled on that are coming in to evidence? Won't you 24 please do that? 25 THE COURT: Well, I'll have to review that. Do PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 229 1 you have any authority that supports that? 2 MR. VICKERY: I do have authority that supports 3 that. The authority -- I'll have to look for my rule, 4 but it is that rule that gives the Court the power and 5 the discretion to conduct the presentation of the 6 trial. And I think that having been asked by Lilly to 7 rule on these numerous objections in advance and 8 having spent the time and done that -- 9 THE COURT: Well, I don't give that any weight 10 in this consideration. 11 MR. VICKERY: I think that when a Court knows 12 that evidence is coming in, when counsel know -- now 13 it would be irresponsible, okay, for me if I didn't 14 know an exhibit was coming in, to throw it up on the 15 screen and show it to this jury, but having invested 16 the time that we have and the Court has and knowing 17 that this is relevant, you know, it's coming in. You 18 folks are going to get to see it later, now let me 19 help you put it all in context, that's just a very 20 important thing, and I think the Court clearly has the 21 discretion. It's a discretionary matter. I don't 22 think no one can fault you one way or the other on 23 doing it, but it falls within your discretion and I 24 would just urge you to allow us to do it. 25 THE COURT: Do you agree that it's PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 230 1 discretionary, Mr. See? 2 MR. SEE: I'm just thinking a minute because 3 technically, the items are not in evidence. And not 4 being in evidence, ought not to be published to the 5 jury, so I think there are items in evidence that 6 ought not to be published to the jury, not until 7 they're admitted. I guess that's how I look at it. 8 THE COURT: Well, if you can come up with 9 authority that satisfies me, that specifically your 10 exhibits that haven't been introduced yet, can be used 11 in your opening statement and published to the jury, 12 I'll allow it. Otherwise, I won't. 13 MR. VICKERY: Okay. Off the top of my head, 14 the authority that immediately jumps to mind is the 15 very instruction that the Court gives the jury, what 16 the lawyers say to you is not evidence. You will hear 17 the evidence in the trial. 18 THE COURT: Well, I think you've got to do 19 better than that. 20 MR. VICKERY: I will go looking for a case that 21 says it. My guess, Your Honor, is that because it's 22 discretionary, no lawyer in this country has ever seen 23 fit to make an appellant issue out of it. That there 24 won't be any reported case authority on it because of 25 the very simple reason, the Court has such discretion PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 231 1 to do it that no one will have written on it. I'm 2 looking for a needle in a haystack when I'm looking 3 for authority on that. 4 THE COURT: Well, You're going to have to 5 satisfy me on that. 6 MR. VICKERY: I will try first thing in the 7 morning. 8 THE COURT: We'll start at nine o'clock 9 tomorrow morning. 10 MR. VICKERY: Thank you, Your Honor. 11 THE CLERK: All rise. 12 (Whereupon, the proceedings were adjourned at 13 4:40 p.m.) 14 15 16 17 18 19 20 21 22 23 24 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 232 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 transcript of proceedings in Civil No. 7 95-00185 ACK, Susan K. Forsyth, et al. vs. Eli Lilly 8 and Company, et al., at Honolulu, Hawaii, on March 4, 9 1999, before the Honorable Alan C. Kay, United States 10 District Judge. 11 DATED: December 13, 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