2626 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 ) Pages 2,626 - 2,784 of the Estates of June M. ) 6 Forsyth and William D. ) Forsyth, and WILLIAM F. ) 7 FORSYTH, JR., ) ) 8 Plaintiffs, ) ) 9 vs. ) ) 10 ELI LILLY AND COMPANY, ) an Indiana corporation, ) 11 et al., ) ) 12 Defendants. ) __________________________) 13 14 TRANSCRIPT OF PROCEEDINGS 15 The above-entitled matter came on for trial on 16 Wednesday, March 31, 1999 at 9:15 a.m. at Honolulu, 17 Hawaii. 18 BEFORE: THE HONORABLE ALAN C. KAY 19 United States District Judge District of Hawaii 20 21 REPORTED BY: TINA M. STUHR, RPR, CSR #360 Notary Public, State of Hawaii 22 PACIFIC REPORTING SERVICES UNLIMITED, INC. 23 733 Bishop Street Suite 2090, Makai Tower 24 Honolulu, Hawaii 96813 (808) 524-PRSU 25 2627 1 APPEARANCES: 2 For Plaintiffs: ANDY VICKERY, ESQ. Vickery & Waldner 3 2929 Allen Parkway Suite 2410 4 Houston, Texas 77019 5 KAREN BARTH, ESQ. Baum, Hedlund, Aristei, Guilford 6 & Downey 12100 Wilshire Boulevard 7 Suite 950 Los Angeles, California 90025 8 ROY K.S. CHANG, ESQ. 9 Shim & Chang 333 Queen Street 10 Suite 900 Honolulu, Hawaii 96813 11 For Defendant: ANDREW SEE, ESQ. 12 MICHELLE MANGRUM, ESQ. Shook, Hardy & Bacon L.L.P. 13 One Kansas City Place 1200 Main Street 14 Kansas City, Missouri 64105 15 EDMUND BURKE, ESQ. Burke Sakai McPheeters Bordner 16 Iwanaga & Estes 737 Bishop Street 17 Suite 3100 - Mauka Tower Honolulu, Hawaii 96813 18 19 20 21 22 23 24 25 2628 1 I N D E X 2 PAGE 3 JURY INSTRUCTIONS 2630 4 5 CLOSING ARGUMENTS: 6 By Mr. Vickery 2647 By Mr. See 2683 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 2629 1 THE CLERK: Civil No. 95-00185 ACK, Susan K. 2 Forsyth, et al. versus Eli Lilly and Company, et al. 3 MR. VICKERY: Good morning, Your Honor. Andy 4 Vickery, Karen Barth, and Roy Chang for the Forsyth 5 family. 6 THE COURT: Good morning. 7 MR. SEE: Good morning, Your Honor. Andy See, 8 Michelle Mangrum, and Ed Burke on behalf of Eli Lilly 9 and Company. 10 THE COURT: Good morning. Good morning, ladies 11 and gentlemen of the jury. This morning first we'll 12 have the instructions read to you and then after that, 13 the parties will have their final argument, with the 14 plaintiff going first and then the defendant and then 15 the plaintiff will have the final argument. 16 My clerk is going to read the instructions to 17 you because I don't think my voice will hold up, but I 18 want you to listen to them, and we'll also pass out 19 the instructions to you and I want you to read them to 20 yourself silently as my clerk is reading them to you 21 and to consider it as though I was instructing you 22 rather than my clerk. 23 My clerk will now deliver the instructions 24 after the jury receives a copy. 25 MR. SCARBOROUGH: Jury Instruction No. 1, 2630 1 Members of the Jury: You have now heard all of the 2 evidence and will shortly hear the argument of 3 counsel. It becomes my duty to give you the 4 instructions of the Court concerning the law 5 applicable to this case. 6 It is your duty as jurors to follow the law as 7 I shall state it to you and to apply that law to the 8 facts as you find them from the evidence in the case. 9 You are not to single out one instruction alone as 10 stating the law, but must consider the instructions as 11 a whole. Neither are you to be concerned with the 12 wisdom of any rule of law stated by me. 13 Jury Instruction No. 2, regardless of any 14 opinion you may have as to what the law is or ought to 15 be, it would be a violation of your sworn duty to base 16 a verdict upon any view of the law other than that 17 given in the instructions of the Court, just as it 18 would also be a violation of your sworn duty, as 19 judges of the facts, to base a verdict upon anything 20 other than the evidence in the case. 21 In deciding the facts of this case, you must 22 not be swayed by bias or prejudice or favor as to any 23 party. Our system of law does not permit jurors to be 24 governed by prejudice or sympathy or public opinion. 25 Both the parties and the public expect that you will 2631 1 carefully and impartially consider all the evidence in 2 the case, follow the law as stated by the Court, and 3 reach a just verdict regardless of the consequences. 4 This case should be considered and decided by 5 you as an action between persons of equal standing in 6 the community and holding the same or similar stations 7 in life. A corporation is entitled to the same fair 8 trial at your hands as is a private individual. The 9 law is no respecter of persons, and all persons stand 10 equal before the law and are to be dealt with as 11 equals in a court of justice. 12 Jury Instruction No. 3, if in these 13 instructions any rule, direction, or idea is repeated 14 or stated in varying ways, no emphasis thereon is 15 intended by me and none must be inferred by you. For 16 that reason, you are not to single out any certain 17 sentences or any individual point or instruction and 18 ignore the others, but you are to consider all the 19 instructions as a whole and to regard each in the 20 light of all the others. 21 The order in which the instructions are given 22 has no significance as to their relative importance. 23 Jury Instruction No. 4, as stated earlier, it 24 is your duty to determine the facts, and in so doing 25 you must consider only the evidence I have admitted in 2632 1 the case. The term "evidence" includes the sworn 2 testimony of the witnesses and the exhibits admitted 3 in the record. 4 Remember that any statements, objections, or 5 arguments made by the lawyers are not evidence in the 6 case. The function of the lawyers is to point out 7 those things that are most significant or most helpful 8 to their side of the case, and in so doing, to call 9 your attention to certain facts or inferences that 10 might otherwise escape your notice. In the final 11 analysis, however, it is your own recollection and 12 interpretation of the evidence that controls in the 13 case. What the lawyers say is not binding upon you. 14 So, while you should consider only the evidence 15 in the case, you are permitted to draw such reasonable 16 inferences from the testimony and exhibits as you feel 17 are justified in light of common experience. In other 18 words, you may make deductions and reach conclusions 19 which reason and common sense lead you to draw from 20 the facts which have been established by the testimony 21 and evidence in the case. 22 Jury Instruction No. 5, you must not consider 23 as evidence any statement of counsel made during the 24 trial; however, if counsel for the parties have 25 stipulated to any fact, or any fact has been admitted 2633 1 by counsel, you will regard that fact as being 2 conclusively proved. 3 As to any question to which an objection was 4 sustained, you must not speculate as to what the 5 answer might have been or as to the reason for the 6 objection. 7 You must not consider for any purpose any offer 8 of evidence that was rejected, or any evidence that 9 was stricken out by the Court. Such matter is to be 10 treated as though you had never known of it. 11 You must never speculate to be true any 12 insinuation suggested by a question asked a witness. 13 A question is not evidence and may be considered only 14 as it supplied meaning to the answer. 15 Jury Instruction No. 6, evidence may be either 16 direct or circumstantial. It is direct evidence if it 17 proves a fact, without an inference, and which in 18 itself, if true, conclusively establishes that fact. 19 It is circumstantial evidence if it proves a fact from 20 which an inference of the existence of another fact 21 may be drawn. 22 An inference is a deduction of fact that may 23 logically and reasonably be drawn from another fact or 24 group of facts established by the evidence. 25 The law makes no distinction between direct and 2634 1 circumstantial evidence as to the degree of proof 2 required; each is accepted as a reasonable method of 3 proof and each is respected for such convincing forces 4 as it may carry. 5 Jury Instruction No. 7, the Court may take 6 judicial notice of certain facts or events. When the 7 court declares it will take judicial notice of some 8 fact or event, you may accept the Court's declaration 9 as evidence and regard as proved the fact or event 10 which has been judicially noticed, but you are not 11 required to do so since you are the sole judges of the 12 facts. 13 Jury Instruction No. 8, certain testimony has 14 been read into evidence from depositions. A 15 deposition is testimony taken under oath before the 16 trial and preserved in writing. You are to consider 17 that testimony as if it had been given in court. 18 Jury Instruction No. 9, now, I have said that 19 you must consider all of the evidence. This does not 20 mean, however, that you must accept all of the 21 evidence as true or accurate. 22 You are the sole judges of the credibility or 23 believability of each witness and the weight to be 24 given to his or her testimony. In weighing the 25 testimony of a witness you should consider his or her 2635 1 relationship to the plaintiff or to the defendant; his 2 or her interest, if any, in the outcome of the case; 3 his or her manner of testifying; his or her 4 opportunity to observe or acquire knowledge concerning 5 the facts about which he or she testified; his or her 6 candor, fairness, and intelligence; and the extent to 7 which he or she has been supported or contradicted by 8 other credible evidence. You may, in short, accept or 9 reject the testimony of any witness in whole or in 10 part. 11 Also, the weight of the evidence is not 12 necessarily determined by the number of witnesses 13 testifying as to the existence or non-existence of any 14 fact. You may find that the testimony of a smaller 15 number of witnesses as to any fact is more credible 16 than the testimony of a larger number of witnesses to 17 the contrary. 18 Jury Instruction No. 10, a witness may be 19 discredited or impeached by contradictory evidence, by 20 a showing that he or she testified falsely concerning 21 a material matter, or by evidence that at some other 22 time the witness has said or done something which is 23 inconsistent with the witness' present testimony, or 24 has failed to say or do something consistent with the 25 present testimony. 2636 1 If you believe that any witness has been so 2 impeached, then it is your exclusive province to give 3 the testimony of that witness such credibility or 4 weight, if any, as you may think it deserves. 5 Jury Instruction No. 11, the rules of evidence 6 provide that if scientific, technical, or other 7 specialized knowledge might assist the jury in 8 understanding the evidence or in determining a fact in 9 issue, a witness qualified as an expert by knowledge, 10 skill, experience, training, or education may testify 11 and state his or her opinion concerning such matters. 12 You should consider each expert opinion 13 received in evidence in this case and give it such 14 weight as you may think it deserves. If you should 15 decide that the opinion of an expert witness is not 16 based upon sufficient education and experience, or if 17 you should conclude that the reasons given in support 18 of the opinion are not sound, or that the opinion is 19 outweighed by other evidence, then you may disregard 20 the opinion entirely. 21 Jury Instruction No. 12, the burden is on the 22 plaintiff in a civil action such as this to prove 23 every essential element of his or her claim by a 24 preponderance of the evidence. A preponderance of the 25 evidence means such evidence as, when considered and 2637 1 compared with that opposed to it, has more convincing 2 force and produces in your minds a belief that what is 3 sought to be proved is more likely true than not true. 4 In other words, to establish a claim by a 5 preponderance of the evidence merely means to prove 6 that the claim is more likely so than not so. 7 In determining whether any fact in issue has 8 been proved by a preponderance of the evidence, the 9 jury may consider the testimony of all the witnesses, 10 regardless of who may have called them, and all the 11 exhibits received in evidence, regardless of who may 12 have produced them. If the proof should fail to 13 establish any essential element of plaintiffs' claim 14 by a preponderance of the evidence, the jury should 15 find for the defendant as to that claim. 16 Jury Instruction No. 13, the essential elements 17 of a claim based upon an alleged defect from failure 18 to warn are: 1, the defendant was the manufacturer of 19 a product, namely, Prozac; 2, the product was 20 defective; 3, the product defect was a cause of jury 21 to plaintiffs; 4, plaintiffs' injury resulted from a 22 use of the product that was reasonably foreseeable to 23 the defendant. 24 A product is defective if: A, the use of the 25 product in a manner that is reasonably foreseeable by 2638 1 the defendant involves a substantial danger that would 2 not be readily recognized by physicians; B, this 3 danger was known or knowable in light of the best 4 scientific and medical knowledge available at the time 5 of the manufacture and distribution; and C, the 6 manufacturer failed to give an adequate warning of 7 that danger. 8 In the case of prescription drugs, the warning 9 must be given to the physician and not the patient. 10 Jury Instruction No. 14, the law recognizes 11 that there are some products which by their very 12 nature cannot be made completely safe. These include 13 some prescription drugs. Products of this nature are 14 said to be unavoidably unsafe. In this case, the 15 parties have stipulated that Prozac falls in this 16 category. 17 If these products are properly prepared and 18 accompanied by proper directions and warning, then 19 they are not defective within the meaning of the law, 20 and liability for injuries caused by these products 21 will not be imposed on their manufacturer. The reason 22 is because the risk of harm is justified by the 23 possible benefits of releasing such products on the 24 market, provided, of course, they are accompanied with 25 proper warnings and instructions. 2639 1 Jury Instruction No. 15, the law presumes that 2 a prescribing doctor will heed legally adequate 3 warnings and follow appropriate instructions. 4 Therefore, if you find that Lilly failed to give 5 appropriate warnings and instructions, you are 6 entitled to presume that the warnings and instructions 7 would have been heeded by Dr. Riggs Roberts and 8 Dr. Randolph Neal, and the risk would have thereby 9 been avoided in the absence of evidence to rebut this 10 presumption. 11 Jury Instruction No. 16, the plaintiffs seek to 12 recover damages based upon a claim of negligence by 13 the supplier of a product. The essential elements of 14 such a claim are: One, the defendant was the supplier 15 of a product; namely, Prozac; two, the defendant was 16 negligent; and three, the negligence of that defendant 17 was the cause of injury and damage to the plaintiff. 18 Jury Instruction No. 17, one who supplies a 19 product for another to use, which the supplier knows 20 or has reason to know is dangerous or is likely to be 21 dangerous for the use for which it is supplied, has a 22 duty to use reasonable care to give warning of the 23 dangerous condition of the product or facts which make 24 it likely to be dangerous to those whom the supplier 25 should expect or use the product or be endangered by 2640 1 its probable use if the supplier has reason to believe 2 that they will not realize its dangerous condition. A 3 failure to fulfill that duty is negligence. 4 In the case of prescription drugs, the warning 5 must be given to the physician. 6 Jury Instruction No. 18, the law defines cause 7 in its own particular way. A cause of injury, damage, 8 loss, or harm is something that is a substantial 9 factor in bringing about injury, damage, loss, or 10 harm. There may be more than one cause of an injury. 11 Jury Instruction No. 19, the occurrence of an 12 injury does not raise a presumption that a product is 13 defective or that the defendant's conduct is a direct 14 cause of the injury. 15 Jury Instruction No. 20, an intervening and 16 superseding cause is one that interrupts or breaks the 17 sequence of events between a defendant's act and a 18 plaintiff's injury. A party acting independently in a 19 manner unforeseeable to the defendant will break the 20 causal connection between defendant's act and 21 plaintiff's injury if that party's act is the sole 22 cause of the injury. 23 If you find that William D. Forsyth, Sr.'s acts 24 of killing June M. Forsyth and committing suicide were 25 not caused by the ingestion of Prozac, then you should 2641 1 return a verdict in favor of Defendant Lilly. 2 Jury Instruction No. 21, the parties have 3 requested the Court to take judicial notice of the 4 fact that Eli Lilly's manufacturing and marketing of 5 Prozac is regulated by the FDA. The Court has granted 6 the parties request and has further permitted 7 introduction of both testimony and documentary 8 evidence concerning such regulation. 9 The Court will now instruct you further with 10 regard to your consideration of such judicial notice 11 and evidence. 12 The Federal Food and Drug Administration 13 regulates drugs like Prozac to protect the general 14 public health and welfare. To do so, it requires a 15 drug manufacturer to meet certain safety and efficacy 16 standards and requires certain warnings to be given. 17 The Federal Food and Drug Administration has approved 18 Prozac for use in the United States and approved the 19 package insert or labeling for Prozac which was in 20 effect in 1992 and 1993. 21 However, the fact that a warning may or may not 22 be either required by or acceptable to the FDA is not 23 determinative of your verdict. Likewise, the fact 24 that the FDA has approved a certain drug is not 25 determinative of your verdict. You may consider 2642 1 evidence of FDA activity along with all of the other 2 evidence in the case in deciding whether or not Eli 3 Lilly's conduct caused the deaths of William and June 4 Forsyth. 5 Jury Instruction No. 22, it is the duty of the 6 Court to instruct you about the measure of damages. 7 By instructing you on damages, the Court does not mean 8 to suggest for which party your verdict should be 9 rendered. If you find for plaintiffs on plaintiffs' 10 claims, you must determine plaintiffs' damages. 11 Plaintiffs have the burden of proving damages by a 12 preponderance of the evidence. 13 Damages means the amount of money which will 14 reasonably and fairly compensate the plaintiffs for 15 any injury you find was caused by the defendant. Your 16 award must be based upon evidence and not upon 17 speculation, guesswork, or conjecture. 18 Jury Instruction No. 23, plaintiffs in this 19 action sued to recover damages for the deaths of June 20 M. Forsyth and William D. Forsyth, Sr. If you decide 21 for plaintiffs on the question of liability, in 22 determining the amount of damages they are entitled to 23 recover, you may consider the following items: One, 24 loss of love and affection, including loss of society, 25 companionship, comfort, consortium, or protection by 2643 1 June M. Forsyth and William D. Forsyth, Sr. to 2 plaintiffs William D. Forsyth, Jr. and Susan K. 3 Forsyth; two, loss of attention, advice, or counsel of 4 June M. Forsyth and William D. Forsyth, Sr. to 5 plaintiffs William D. Forsyth, Jr. and Susan K. 6 Forsyth; three, loss of parental care, training, 7 guidance, or education by June M. Forsyth and William 8 D. Forsyth, Sr., to plaintiffs William D. Forsyth, Jr. 9 and Susan K. Forsyth; four, June M. Forsyth and 10 William D. Forsyth's reasonable burial expenses; and 11 five, physical and mental pain and suffering by June 12 M. Forsyth and William D. Forsyth, Sr. prior to their 13 deaths. 14 Jury Instruction No. 24, of course, the fact 15 that I have given you instructions concerning the 16 issue of plaintiffs' damages should not be interpreted 17 in any way as an indication that I believe the 18 plaintiffs should or should not prevail in this case. 19 Your verdict must represent the considered 20 judgment of each juror. In order to return a verdict, 21 it is necessary that each juror agree thereto. In 22 other words, your verdict must be unanimous. It is 23 your duty as jurors to consult with one another and to 24 deliberate with a view to reaching an agreement if you 25 can do so without violence to individual judgment. 2644 1 Each of you must decide the case for yourself, 2 but only after an impartial consideration of all of 3 the evidence in the case with your fellow jurors. In 4 the course of your deliberations, do not hesitate to 5 re-examine your own views and change your opinion, if 6 convinced it is erroneous, but do not surrender your 7 honest conviction as to the weight or effect of the 8 evidence solely because of the opinion of your fellow 9 jurors or for the mere purpose of returning a verdict. 10 Remember, at all times you are not partisans. 11 You are judges. Judges of the facts. Your sole 12 interest is to seek the truth from the evidence in the 13 case. 14 Jury Instruction No. 25, upon retiring to the 15 jury room, you should first select one of your members 16 to act as a foreperson who will preside over your 17 deliberations and will be your spokesman here in 18 court. 19 A form of verdict has been prepared for your 20 convenience. This will be the verdict form that you 21 will be receiving. It's entitled verdict, and 22 paragraph one, states, "We the jury in the 23 above-entitled case unanimously find in favor of," 24 then you will notice that there are two separate 25 lines, one under which is plaintiff, Susan K. Forsyth 2645 1 and William F. Forsyth, Jr., and the other, Defendant 2 Eli Lilly and Company. If you should find for 3 plaintiffs, then you would write the word plaintiff 4 above the line stating the plaintiffs' names. If you 5 should find in favor of defendant, then you would 6 write the word defendant over the line saying 7 Defendant Eli Lilly and Company. 8 If you find in favor of plaintiffs Susan K. 9 Forsyth and William F. Forsyth, Jr. in this first 10 paragraph, then you are instructed to carry on to 11 Paragraphs 2, 3 and 4, which are on the second page of 12 the verdict form. If you find in favor of the 13 Defendant Eli Lilly and Company on all claims set 14 forth in Paragraph 1, then you are instructed to not 15 go on to Paragraphs 2, 3, and 4 which are on the 16 second page. 17 Paragraph 2 on the second page states that "On 18 plaintiffs' claim for the wrongful death of June M. 19 Forsyth, we the jury in the above-entitled case 20 unanimously assess damages in the following amounts," 21 and you are instructed to answer in dollars and cents, 22 if any. And then there are separate lines for damages 23 for Susan K. Forsyth and damages for William F. 24 Forsyth, Jr. 25 Paragraph 3 states, "On plaintiffs' claim for 2646 1 the wrongful death of William Forsyth, Sr., we the 2 jury in the above-entitled case unanimously assess 3 damages in the following amounts," and once again, you 4 are instructed to answer in dollars and cents, if any. 5 And there are also two separate lines for damages for 6 Susan K. Forsyth and damages for William F. Forsyth, 7 Jr. 8 And then Paragraph 4 states that "On the claim 9 of Plaintiff Susan K. Forsyth as personal 10 representative of the estates of William D. Forsyth, 11 Sr. and June M. Forsyth, for the personal injury of 12 William D. Forsyth, Sr. and June M. Forsyth, we the 13 jury in the above-entitled case unanimously assess 14 damages in the following amounts," and once again, you 15 are instructed to answer in dollars and cents, if any. 16 And then there are separate lines for damages 17 sustained by June M. Forsyth and damages sustained by 18 William D. Forsyth, Sr. 19 You will take the verdict form to the jury room 20 and when you have reached unanimous agreement as to 21 your verdict, you will have your foreperson fill it 22 in, date and sign it, and then you will return to the 23 courtroom. 24 If, during your deliberations, you should 25 desire to communicate with the Court, please reduce 2647 1 your message or question to writing signed by the 2 foreperson and pass the note to the marshal who will 3 bring it to my attention. I will then respond as 4 promptly as possible, either in writing or by having 5 you return to the courtroom so that I can address you 6 orally. 7 I caution you, however, with regard to any 8 message or question you might send that you should 9 never state or specify your numerical division at that 10 time. 11 THE COURT: Mr. Vickery. 12 MR. VICKERY: Thank you, Your Honor. May it 13 please the Court, Susan, Bill, friends, counsel, 14 ladies and gentlemen of the jury, I stand before you 15 on behalf of my friends Susan and Bill Forsyth to try 16 to do the job that Mr. Scarborough just read for you 17 on behalf of the Court is my job, which is to call 18 your attention to matters in evidence that might 19 otherwise escape your notice, but I also stand before 20 you, quite frankly, on behalf of June Forsyth and 21 William D. Forsyth, Sr. and I speak on their behalf. 22 This is a case, a civil action, about 23 drug-induced violence, about the Prozac-induced 24 wrongful deaths of June Forsyth and Bill Forsyth, Sr. 25 That's what this case is about. 2648 1 Now, back when we started in the opening 2 statements, we were talking about Prozac induced and 3 what is a cause, and you probably thought then, boy, 4 I'm going to have to decide which one it is, is it 5 Prozac, like Mr. Vickery said, or is it depression as 6 Mr. See said? Which one is it? And I've got to 7 choose between the two, but it should be abundantly 8 clear to you now from these instructions that were 9 just read to you, that that's not the law. That's not 10 the law at all. 11 The law is that if Prozac was a substantial 12 factor, and there may be more than one, indeed, with 13 something as complex as human behavior like this, 14 there is more than one in any instance, as 15 Dr. Matthews testified, but if Prozac was a 16 substantial factor, then this company is responsible. 17 Now, I have the burden of proof in this case 18 and to help you assess the relative likelihood that 19 Prozac contributed in a substantial way or that we can 20 put the sole cause, the intervening cause on 21 depression, I brought to you two of the best experts 22 that I could find in the world. Guys who wrote the 23 book. 24 With respect to the first issue, I brought the 25 fellow who wrote the book on the antidepressant era, a 2649 1 man who had never testified in his life, as it was 2 obvious, I think, from his demeanor on the stand, 3 Dr. David Healy, and he explained to you in some great 4 detail what is the best science in the case. The best 5 science that's available is the science that they 6 chose not to do. The challenge, dechallenge, 7 rechallenge test. It's the best that's available for 8 this particular purpose and they drafted a protocol to 9 use it, but they chose not to do it. They chose to do 10 what Dr. Teicher said, which is to stick their heads 11 in the sand rather than give you that information. 12 And Dr. Healy explained to you about the role 13 of akathisia, how it's difficult to diagnose, how it's 14 clear-cut, from your perspective, as a patient, but 15 not from the doctor's perspective unless they know to 16 look at it, and I'm glad that Dr. Reus looked at that 17 DSM-IV because we learned that it wasn't available to 18 Dr. Neal. It wasn't even published until 1994, and 19 even today, even six months ago, the experts agree 20 that akathisia is largely a subjective matter of 21 subjective restlessness, and I'll have considerably 22 more to talk to you about concerning akathisia. 23 But this is the man that I brought, David 24 Healy, to help you understand the causative role that 25 Prozac plays, although his testimony is not the only 2650 1 causative evidence. I mean, it's very clear that 2 Dr. Matthews said that psychosis was a causative agent 3 in these -- 4 MR. SEE: Your Honor, I object. That misstates 5 a matter that is not in evidence in the case. 6 THE COURT: I'll sustain the objection. 7 MR. VICKERY: The jury will recall 8 Dr. Matthews' testimony about psychosis, what he said. 9 Now, how about the other side? Depression is a bad 10 disease. Well, I brought to you there a guy that 11 wrote the book on assessment and prediction of 12 suicide, Dr. Ron Maris, or that edited this book 13 actually, and wrote many others. 14 THE COURT: And I do want to remind the jury, 15 that you are the judges of the facts and if the 16 attorneys misstate the facts or the Court misstates 17 the facts, it's your memory that controls. 18 MR. VICKERY: Thank you, Your Honor, I 19 appreciate that. 20 I brought Dr. Maris realizing that Mr. See 21 would say, oh, he was at risk. Isn't that true, he 22 was at risk, Dr. Maris? And Dr. Maris said, yes, he 23 was at risk. Now, why would I do that? Am I just a 24 stupid lawyer from Texas or did I want you to have a 25 real handle on the likelihood, the likelihood that all 2651 1 of those factors, you can take every one from their 2 perspective, what's the likelihood that they would 3 contribute? Well, I'll tell you what it is. I better 4 watch my time because the Court's given me an hour 5 this morning. 6 The likelihood is real simple, even for those 7 people in the danger zone, the suicide zone, he said 8 only one out of a hundred ever commit suicide. Even 9 the ones in the suicide zone. But of those that do, 10 only one out of a hundred kill someone else first. So 11 if you want to say what's the likelihood that all of 12 those risk factors and life stressors would cause this 13 man to kill his wife and then himself, you have to add 14 two zeros folks and that's one in 10,000. That's the 15 defense in this case. That's the likelihood of the 16 defense in this case stands. 17 Now, in the time that the Court has allotted to 18 me this morning, I'm going to basically divide it into 19 three, roughly, twenty-minute segments, and the first 20 one I want to discuss with you, your role and my role 21 and the standards that we have to use to resolve this 22 case, the standards right here that have just been 23 read to you. In the second 20 minutes, I want to 24 discuss with you something that you will have 25 available to you that unfortunately Lilly's experts 2652 1 didn't have available, which is the documents, the 2 internal documents that show what Eli Lilly knew about 3 the risks that it was exposing people to. I don't 4 know why they didn't share them with their experts, 5 but they didn't and in considering what weight to give 6 the opinion of those experts, you might what to 7 consider the fact that they only had half the story, 8 and under the rulings of the Court, I couldn't ask 9 them about something they didn't know about, but you 10 can say, wonder what they would have said if they had 11 known this? 12 And then in the third section, I'm going to 13 fulfill my duty as an officer of this court to talk to 14 you about the damages in this case. 15 THE COURT: Mr. Vickery, just so there isn't 16 any misunderstanding, the Court has not placed a time 17 limitation. 18 MR. VICKERY: Oh, okay. Thank you, Your Honor. 19 I appreciate that. I'll try to use my time wisely 20 then, but I appreciate that extra time if I need it. 21 Now, I told you at the start of this case, that 22 there were five points that I wanted you to try to 23 remember throughout the case and here they are, and 24 you can tell what a good planner I am, you start 25 writing five and at the bottom they're all crowded. 2653 1 But Prozac is unsafe for some people. It's an unsafe 2 drug for some people. Not everybody, but for some 3 people. I don't know whether it's 3-1/2 percent as 4 Dr. Teicher said in his article or if it's 5.3 percent 5 if we look at the tiny little print in the label that 6 shows us how many people dropped out, but it's unsafe 7 for some people. 8 And, indeed, you just heard the stipulation 9 read to you by Mr. Scarborough, that both sides admit 10 that it is unavoidably unsafe, which simply means 11 under the law, warn. You've got to warn. You've got 12 to tell the prescribing physicians about the unsafe 13 condition for some people and you especially have to 14 do it when the unsafeness regards life or death 15 matters as they clearly do. 16 I told you, number three, that I was going to 17 show you that Lilly knew and had failed to warn and 18 that's what I'm going to spend the second segment with 19 you this morning doing, to show you that Lilly knew 20 and they failed to warn. 21 I told you, number four, that under Hawaii law 22 Lilly is liable if the drug or a lack of a warning was 23 a substantial factor. Now, I want to talk to you 24 about substantial factor for a minute. 25 I am from Texas. You probably gathered that 2654 1 from my accent and the fact that I introduced myself 2 that way, and I have tried to learn the local customs 3 and learn the local law, and I've had real good help 4 from Mr. Chang. And so I said to him, Roy, help me 5 understand the Hawaii concept of substantial factors 6 because we don't use exactly those words in Texas. 7 And he said, well, the way I usually explain it is 8 it's just a factor that has some substance to it. It 9 doesn't mean that it's the primary factor because 10 there could be many, but it's a factor that has some 11 substance to it. 12 And I said give me a example. He said it's 13 like baking a cake. Baking a cake, there's eggs, 14 there's flour, there's shortening, there's sugar, 15 there's butter, there's heat. You don't get the cake 16 unless there's something at the end that triggers it 17 to become a cake, and each of those are factors which 18 have substance. 19 THE COURT: Mr. Vickery, Instruction No. 18 20 defines what a cause is. 21 MR. VICKERY: Thank you, Your Honor. 22 THE COURT: But I don't want you to go beyond 23 the jury instructions in defining the law. 24 MR. VICKERY: Okay, sir. The Court has 25 directed me to Instruction No. 18, which says, "A 2655 1 cause of injury, damage, loss, or harm is something 2 that is a substantial factor in bringing about the 3 injury. There may be more than one cause of an 4 injury." 5 And I told you that, and you probably wondered 6 then why is he talking about Hawaii law so much? Why 7 is he emphasizing that so much? We know it. We're in 8 Hawaii. Well, the reason obviously is because of the 9 role of the FDA and the evidence from the FDA. I knew 10 Lilly would want to talk a lot about the FDA. But you 11 see, the FDA is concerned with a compound, fluoxetine 12 hydrochloride, and the general safety and welfare of 13 the people. Hawaii consumer law, though, is concerned 14 with consumers, the protection of individuals, and 15 that's why Hawaii law governs. 16 And finally, number five, I told you that we 17 were going to talk about, even though I don't have to 18 prove it to win the case, we're going to talk about 19 the reasonableness of their conduct because they've 20 misled people. It's not just that they failed to 21 warn, it's that they've misled people. They've given 22 them reassurances when they shouldn't. This letter 23 that they're so proud of, this August 31, 1990 24 dear-doctor letter, that's not a warning. It is an 25 antiwarning. It reassures them, don't worry about it. 2656 1 You may have heard some of this, but don't worry about 2 it. And so we're going to talk about that. 3 Now, your role, my role, what are we all doing 4 here? I thank you for allowing me to spend time with 5 you here on your island and to present the case for 6 these fine people. I've been a lawyer for 27 years 7 and I've tried 50 or more jury cases and it's 8 something that I enjoy doing and I appreciate the 9 opportunity to plead my client's case for you. 10 I also appreciate the attention that you have 11 given to the case. Now, a lot of lawyers always want 12 to really thank the jury for their jury service and 13 I'll tell you, I don't do that and I'll tell you why. 14 Because it is so important to the fabric of our 15 society that people like you help your fellow man to 16 resolve disputes, and were I to represent you or 17 anyone in this courtroom, I would insist that your 18 fellow citizens do the same for you. And so I don't 19 thank you for fulfilling your civic duty in serving, 20 but I do thank you for the patience and attention that 21 you've shown throughout this trial. 22 And if my manners or my accent or my role as an 23 advocate for these people has in any way made your 24 task more difficult, I apologize for that. I know 25 there are at least two instances that I can think of 2657 1 in the course of this trial in which, because of my 2 very strong feelings about it, I probably lost my cool 3 a little bit. I probably lost my cool a little bit 4 with one or two witnesses, and if that distracted you 5 or made your task more difficult, I'm sorry. 6 I try not to look at the jury during the course 7 of the trial. I do it for a couple reasons; one, 8 because the job that you have is so important that I 9 think that it can sometimes be distracting if a lawyer 10 is trying to look you in the eye and see what 11 movements you're making, and another one is, quite 12 frankly, I try to figure out -- in earlier years when 13 I tried to look at juries, I tried to figure out what 14 you're thinking, and as long as I've been doing this, 15 I never can do that. All I can say is that jurors 16 take their jobs seriously. They take their oaths 17 seriously, and so it's best for me to just do my job 18 and let you do yours because it is such an important 19 job. 20 I don't think I've ever heard a better 21 explanation of the role of the jury than Judge Kay 22 gave you at the inception of this trial, when he said 23 that you are the conscience of the community and the 24 cornerstone of the system of justice. 25 You know, you started out by being summoned to 2658 1 a place that you probably didn't want to come to by 2 people that you didn't know. You were given numbers 3 and told where to sit or what order to take. We gave 4 you a 14-page questionnaire and asked you to fill it 5 out and asked some pretty private and probing 6 questions of you and they were probably somewhat 7 intrusive, but they were necessary and we appreciate 8 the information you gave, but look at what a change 9 has happened. We start every day with Ms. Mywa 10 opening the back of this court and saying, "All rise 11 for the jury." Well, no one rises for me when I come 12 in, not even Ms. Barth and she's supposed to, but they 13 do rise for you, because as the judge told you in his 14 instructions, you are the judges of the facts. 15 The way the system works is you decide the 16 facts and the judge then enters a judgment based on 17 your verdict. He can't add a nickel to the damages. 18 The Court decides the law and gives you the law and 19 we're all obligated to follow it, but you are the 20 exclusive judges of the facts and your verdict is oh, 21 so important. 22 Now, there's some other concepts that we're not 23 familiar with generally, the burden of proof and the 24 preponderance of the evidence. Again, the Court gave 25 you an excellent example, a metaphor that we use, when 2659 1 he gave you the initial instructions and it is the 2 tipping of scales. You put all the evidence in scales 3 and all the evidence for us over here and for them 4 over here, and we don't have to prove anything beyond 5 a reasonable doubt. If the scales of justice tip this 6 way, we win. That's what the preponderance -- 7 THE COURT: Preponderance of the evidence, not 8 beyond a reasonable doubt. 9 MR. VICKERY: That's what I said, we don't have 10 to prove anything beyond a reasonable doubt. We do 11 have to prove it by the preponderance of the evidence. 12 THE COURT: I'm sorry, I misunderstood you. 13 MR. VICKERY: It's weight in the scales of 14 justice, and if the scales tip ever so slightly in one 15 direction or another, that party wins, and we win if 16 the scales tip in our favor. 17 Now, what may you consider? You can consider 18 the evidence in the case, which includes the 19 stipulations and admissions. It includes the -- all 20 those things that I read to you that they admitted 21 about the people bopping other people and being wired 22 and having akathisia and the stipulation that it's an 23 unavoidably unsafe drug. 24 Now, evidence also -- and I always take time to 25 talk to folks about this -- includes direct and 2660 1 circumstantial evidence, and circumstantial 2 evidence -- you know, those of us who garner our 3 knowledge about the law from television think, well, 4 that's not good evidence. It's just circumstantial as 5 if it were second class, but what the Court has 6 instructed you is, the law makes no distinction. 7 Circumstantial evidence can be as powerful to you as 8 direct evidence, and I'll give you two examples. 9 One of them is an island story from well-known 10 literature. Robinson Crusoe thought for a long time 11 he was alone on an island. He thought there was no 12 other human to be a companion. But one day he walked 13 along the beach and he saw human footprints in the 14 sand. That, ladies and gentlemen, is circumstantial 15 evidence, because he knew then he was not alone and 16 subsequently, he found his friend Friday. 17 One that I tell in Texas and this is sort of a 18 Texas story, so bear with me, but it involves a man 19 that was charged criminally for biting off a fellow's 20 ear and the prosecutor had an eyewitness, and said, 21 you know, "Were you an eyewitness to this fight?" 22 "Yes, sir I was." 23 He said, "Did this man bite this fellow's ear 24 off?" 25 He said, "Yes, sir, he sure did." 2661 1 "Thank you. Your witness." 2 And the young defense lawyer said, oh, my 3 goodness, how am I going to win this case with an 4 eyewitness? I've got to discredit this guy, and so 5 she went into this long examination and said, "Okay. 6 Where were you? How was the light? What was your 7 angle?" And really did a good job of undermining the 8 testimony of this witness, and got down and finally 9 said, "You couldn't really see him bite that ear off, 10 could you?" 11 The man said, "No, ma'am, I can't." 12 And she did then what lawyers should never do 13 and that's ask one question too many. And she said, 14 "So why did you say you did know that he bit it off?" 15 He said, "Well, I'll tell you, ma'am. I seen 16 him spit it out." That, ladies and gentlemen, is 17 circumstantial evidence. 18 We don't know all of the circumstances 19 surrounding the last week of Bill and June Forsyth's 20 lives and particularly the last night. We don't know, 21 for example, have no idea, how long Ms. Forsyth lived, 22 how long she lived once the attack started, but the 23 circumstances that you do know, are that she bled to 24 death and that she had a lot of defensive wounds and 25 you are entitled to infer from those circumstances the 2662 1 fact that this lady had some physical and mental 2 suffering before her death. 3 Nor do we know all that occurred to Mr. Forsyth 4 in the hospital. We have a little bit better record 5 of that and you will see when you look at the Castle 6 Medical records that he was complaining of just the 7 kinds of things that patients complain of when they 8 have akathisia; nervousness, restlessness. That it 9 was there, but you see there was no DSM-IV there. 10 Dr. Neal was not advised, look out for this, question 11 the patient for this. So there's no diagnosis. But 12 the circumstances are the ones that caused Dr. Healy 13 to say yes, this man had this condition that's caused 14 by this drug, and Dr. Shlensky, and you're entitled to 15 look at those circumstances and make your own 16 determinations. 17 So what are the substantial factors in the 18 deaths of June and Bill Forsyth? Well, drug-induced 19 akathisia, Prozac-induced akathisia, I believe the 20 weight of the evidence shows you to be a substantial 21 factor. That it was, to use Dr. Maris' words, the 22 trigger of acute lethality. It was the only thing 23 that changed, you see. He had dealt with all of the 24 other life stresses. He had dealt with them a long 25 time before, but that's the only thing that could 2663 1 cause this behavior that changed after February 22nd. 2 Psychosis, I've already mentioned. You'll 3 recall the testimony of Dr. Matthews concerning that. 4 A premature release and no more Xanax. What about 5 that? Dr. Matthews said, well, I think those were 6 substantial factors. Now, that leads me to talk about 7 the role of the doctors, Dr. Neal in particular. It 8 would be easy to, in hindsight, blame Dr. Neal, and 9 I'm sure that if Eli Lilly thinks that Dr. Neal is to 10 blame, that they will argue that to you, that Mr. See 11 will argue that to you, but I bet they won't, you know 12 why? It's not part of their marketing strategy. You 13 can't pick on doctors. 14 MR. SEE: Your Honor, I object. This is a 15 matter about which there is no evidence in this trial. 16 THE COURT: Sustained. 17 MR. VICKERY: You see, I don't criticize 18 Dr. Neal in this. I criticize him for not writing a 19 timely and accurate discharge summary at the time when 20 he was being advised by Mr. Burke's firm over here, 21 but I don't criticize him about not knowing about 22 akathisia and not knowing that he needed to keep him 23 in the hospital longer and not knowing that he needed 24 to continue that benzodiazepine because Lilly didn't 25 tell you. Ignorance is not negligence, and I think 2664 1 these doctors were ignorant about some things because 2 they weren't told. But it is not negligence. So I'm 3 not going to blame them. 4 Now, defect, marketing defect, the Court gives 5 you an instruction on how could this drug be defective 6 if it's sold to 38 million people. It's defective as 7 to those people who need the warning, don't get the 8 warning. If it is unsafe for a few and they don't 9 give the warning, it's unsafe to those few and that's 10 all that means. And certainly the testimony of Drs. 11 Riggs Roberts and Randolph Neal show that they needed 12 warnings and certainly, if we were to take the 13 combined testimony of Dr. Maris and Dr. Reus, they 14 needed warnings because, according to Dr. Maris, this 15 man was in a danger zone. He was in a danger zone. 16 He needed his doctors to be well informed. 17 Now, the Court has instructed you on 18 intervening and superseding cause and told you that 19 that's an unforeseeable cause. It is something that 20 Lilly could not foresee. Well, Lilly couldn't foresee 21 this. So those are the standards under the Court's 22 instruction and our system of justice that you must 23 follow and I hope that my discussion of them will be 24 helpful. 25 I'd like now to turn to the second thing and 2665 1 discuss with you sort of chronologically the 2 documentary evidence that you will have as has come 3 out. Because of the way these things happen, you 4 haven't sort of seen it all in chronological order. 5 These are the documents that Lilly chose not to share 6 with its experts. I have said frequently to young 7 lawyers like my friend Ms. Barth, that a lawyer ought 8 to be able to capture the essence of a case in ten 9 documents, and I'm going to direct your attention to 10 about thirty, but we've got about ten blown up to show 11 you and I urge you to look at all of them and look at 12 them in context, but since you are able to take notes, 13 I'll go through chronologically and tell you the 14 exhibit numbers and page numbers that I think will 15 help you. 16 We're going to start in May of 1994 in Germany 17 with the BGA, and they said that during treatment with 18 the preparation Prozac, 16 suicide attempts were made, 19 two with success. That's two dead people. As 20 patients with a risk of suicide were excluded from the 21 studies, it is probable that the high proportion can 22 be attributed to an action of the preparation Prozac. 23 And that's from Exhibit 42, Page 3, the sixth 24 paragraph. 25 And in January of '85, about eight months 2666 1 later, Lilly got the word the BGA is not going to let 2 you sell Prozac here, and there's two reasons. One of 3 those two reasons was suicidal risk. And what did 4 they do? They said we better go talk to some opinion 5 leaders. That's Exhibit 53. And you have seen the 6 preliminary report from the opinion leader perform 7 another -- Ms. Barth will put it up for us now. This 8 is where they did a benefit risk consideration and 9 they noted that the incidence rate for suicide is 5.6 10 times higher with Prozac than another antidepressant. 11 And he concluded at the end that because of this -- 12 here it is where the incidence rate is 5.6 times 13 higher. 14 Now, they concluded at the end that because of 15 this, maybe we should limit the number of patients. 16 We should limit it to a smaller group of patients, and 17 if we do that, we might get the number of suicides 18 down. The benefit versus risk do not fall in favor of 19 benefits, therefore it is of greatest importance that 20 it is the subgroup who respond better to Fluoxetine 21 than Imipramine, so that the higher incident of the 22 suicide attempts may be tolerable. That's what they 23 decided. And this man is an opinion leader and that's 24 Exhibit 58. 25 And while we're talking about that, I want to 2667 1 urge you to look at Exhibit 1116. This is the final 2 report from this same man and it is in evidence for 3 your consideration and you'll see we change the risk 4 benefit analysis. We're not going to limit the amount 5 of patients, but let's give a warning. Ladies and 6 gentlemen, the things that they were going to warn 7 about, the very things if we accept Daryl Matthews' 8 testimony that would have saved the Forsyth's lives, 9 keep them in the hospital for a little bit longer and 10 make sure he has the sedative medicine Xanax that will 11 then counteract -- 12 MR. SEE: Again, I object to what he said about 13 keeping him in the hospital for a little longer. 14 There is no such evidence in this case. 15 MR. VICKERY: Your Honor, Dr. Matthews said 16 premature release. That's the exact word he used. 17 THE COURT: I'll overrule the objection, but 18 again, I'll caution the jury that it is your memory of 19 what the evidence and testimony has been. 20 MR. VICKERY: Thank you, Your Honor. Now, in 21 June of '86, somebody at Lilly does a draft 22 precaution, not a warning, but it is better than 23 nothing, about psychosis being precipitated or caused 24 by antidepressant therapy. Never appears anywhere in 25 the warnings. 2668 1 Moving forward to August of '89, there's 2 additional feedback regarding Germany, the counter 3 indication because of acute suicidality should become 4 a warning. Somebody, you see, at Lilly thinks that 5 people are entitled to be warned of suicide and that's 6 in Exhibit 88. Later that year in November of '89, 7 there's a letter to the salespeople, people like Amy 8 Lee, although she didn't work for them then, about 9 Prozac-induced akathisia and it refers to this 10 Lipinski article that you have heard talked about. 11 And look at this, they say in the article, the 12 voice -- the authors voice their suspicion that the 13 triad of symptoms anxiety, nervousness, and insomnia, 14 reflect the syndrome of akathisia. 15 Now, that's in Exhibit 91, first page second 16 paragraph and second page last sentence. These are 17 the same three symptoms that caused 5.3 percent of the 18 people to drop out of the clinical trials. 19 So when Dr. Beasley did a meta-analysis of the 20 clinical trials, let's go back and look for those 21 people that had what Teicher was talking about. They 22 weren't there because they dropped out. And the same 23 three symptoms that caused them to drop out were what 24 Lilly knew in '89 was akathisia. 25 In January of '90, the Teicher article comes 2669 1 out or they get a preadvance notice that it's coming 2 out really in the next month, and the internal 3 Exhibit 94 shows that they were aware or had notice 4 this article was going to say that Prozac can induce 5 severe, intense, obsessional suicidal ideation. 6 What did they do? They gave their salespeople 7 a heads up. Do not initiate discussions. They're not 8 part of our current marketing plan. That's 9 Exhibit 15, ladies and gentlemen. 10 Now, come back with me for a minute to January 11 and February of 1990 when they had 20 people working 12 full time on this issue. How easy would it have been 13 to put a warning out? I mean, you folks put warnings 14 out for dangerous beaches. You put warnings if there 15 are shark attacks or even when there are jellyfish. 16 How easy would it have been for them to say, look, 17 tell our salespeople to tell the doctors this can 18 happen in a small percentage of patients? 19 There are things you can do to look for. There 20 are things you can do to protect against it. It would 21 have been so easy, but that's not what they did. What 22 they did is, the top scientist, Leigh Thompson, said, 23 whoa, we're spending a lot of time defending the 24 relationship of murder, suicidal ideation. Exhibit 25 97. 2670 1 The same day he said, "I've talked to Dr. Leber 2 over at the FDA, and although he's a fan of Prozac, 3 he's a political creature and I hope that Patrick" -- 4 I don't know who he is from the evidence -- "realizes 5 that Lilly can go down the tubes if we lose Prozac." 6 That's Exhibit 98. 7 That's what they were focusing on, and as 8 you'll see later in the year, when Dr. Thompson, this 9 same man, the top scientist, designed their 10 priorities, priority number one was to protect Prozac. 11 In June of 1990 Lilly gets a letter from 12 someone about a disturbing number of suicides, and 13 look at this one when you go in the jury room, 14 Exhibit 102, because it says some of these cases 15 appear to be in patients taking Prozac for other 16 reasons. These aren't people who are taking Prozac 17 for depression. What was it Mr. See said, the big bad 18 awful disease depression? Take it out of the 19 equation, and people were still committing suicide. 20 In July of 1990, the public began to briefly be 21 interested, and what did they do? Well, when 22 Dr. Thompson got a call from Paul Leber at the FDA, he 23 talked to him at 6:15 in the morning. Either that 24 means Dr. Leber is a wonderful public servant for you 25 and me or it means he has an awful cozy relationship 2671 1 with Dr. Thompson. You decide which inference is 2 appropriate. But they had a call about suicide. And 3 they decided, well, we're going to work together and 4 we're going to put a cap on the number of events. 5 That's Exhibit 104. 6 Two weeks later they write their salespeople. 7 Again, do you think, well, gosh, they would say, hey, 8 folks, get the word out. Tell doctors this can happen 9 and there are things that they can do to protect their 10 patients. But no, they had a promotional strategy, do 11 not initiate discussions. But if a doctor does say 12 something, what should you do? Should you say, yeah, 13 you know, it can happen. This drug can cause 14 akathisia like Dr. Reus said, and if you're at risk, 15 it can push you over the edge like Dr. Reus said. 16 Did they do that? No. They said, no, reassure 17 them that there is no causal relationship. That is 18 negligence. Exhibit 17. 19 August 31, the dear-doctor antiwarning letter, 20 Exhibit 22. September 12, Lilly is talking to the FDA 21 and they talk about strategy and they say, well, gosh, 22 if FDA presses for a strategy, let's make all of our 23 competitors put a warning out, too. So if they had 24 pressed for a labeling change regarding suicide, then 25 let's go for a class-wide warning, but only as a last 2672 1 resort. And this is the memo where Dr. Thompson said, 2 look, we've got to get the skinny over to Dr. Paul 3 Leber. We need to get a report to him pronto because 4 he is our defender. You must -- the report must move 5 swiftly for approval through Dr. Leber's hands. He is 6 our defender. That's Exhibit 109, ladies and 7 gentlemen. 8 On September 14, 1990, the internal memo from 9 Dr. Heiligenstein to Leigh Thompson says, hey, boss, 10 don't tell everybody that it's the depression making 11 people do it, because we ourselves, we have said, yes, 12 it is reasonably related to the drug on several 13 reports. And you might also want to note that the 14 trials were not intended to address suicide. Isn't 15 that interesting? When they went to look back at it 16 and did a meta-analysis, they didn't consider the fact 17 that the trials didn't address suicide. 18 On October 2 of 1990, Leigh Thompson gets a 19 memo about what are we going to do about these big 20 numbers on suicide? If you look at all the data, 21 they're big numbers. Well, let's show them next to 22 nausea, then they'll seem small. That's Exhibit 113. 23 Then we get to November 7, 1990, when the top 24 scientist at Eli Lilly, Dr. Leigh Thompson, who I sure 25 wanted to question at this trial and I'm sure you 2673 1 wanted to hear from him, said we need to set our 2 priorities up. What are our priorities? 3 MR. SEE: Your Honor, I object to that 4 argument. That's improper argument. Dr. Thompson no 5 longer works for the company. 6 MR. VICKERY: Your Honor, he most certainly is 7 not. He's on Lilly's witness list. 8 THE COURT: I'll sustain the objection. 9 MR. VICKERY: What are our priorities? I'd 10 suggest that the priorities are number one, protect 11 Prozac. Protect Prozac. Not inform the doctors. Not 12 protect patients. Protect Prozac. And then he talks 13 about this elaborate scheme that he had to get the 14 10,000 patients the FDA wanted to study. 15 Now, Dr. Beasley studied 3,065, but 16 Dr. Thompson said, well, there's an FDA mandated study 17 to look at suicidality and they want 10,000 patients 18 looked at, so why don't we study another drug and 19 we'll tie up these investigators for several years. 20 This shows you the priorities of Eli Lilly protecting 21 Prozac is their number one priority. 22 In that same month, folks over at -- in 23 Germany, a guy named Claude Bouchy was really worried 24 about some of the measures that were being taken to 25 protect Prozac. He said, wait a minute. We're told 2674 1 to change -- when we code this stuff, we're told to 2 change suicidal ideation to depression. Suicidal 3 ideation. I'm thinking about killing myself. Oh, you 4 must be depressed. And he said, I don't think I could 5 explain it to the BGA or to a judge, I guess they 6 don't have juries over there, or to a reporter or even 7 to my family why we do this on such a sensitive issue 8 as suicidal ideation. Look at Exhibit 117 when you 9 get back there. 10 You'll see the one on the next day, in the same 11 manner, Exhibit 118, where he says, I personally 12 wonder whether we're helping the credibility of our 13 system, our adverse drug event system, by calling 14 overdose what a physician reports as suicide, and 15 calling depression what a physician is reporting as 16 suicidal ideation. Garbage in. Garbage out. Plain 17 and simple. 18 Now, the following spring, April 15, somebody 19 at Lilly, somebody in the PR department at Lilly wrote 20 what I submit to you, ladies and gentlemen, is the 21 script or screenplay for the defense in this case. It 22 is quite simply, hey, we're going on television, and 23 you need to know what you need to do. 24 Message goals, whatever questions you are asked 25 or whatever direction the interviewers take, the three 2675 1 points we want to establish are: One, no medicine has 2 been more thoroughly researched, even though they 3 didn't look at suicidality as we've just seen. Say, 4 we've studied this whole medicine. Number two, it's 5 in the disease not the drug. That's the theme of the 6 defense. That's the whole script of the defense. And 7 number three, if you warn, people will be scared away. 8 They won't get the treatment they need. 9 How can that be if you warn physicians and tell 10 physicians what they need to know? And then he tells 11 them, tone. Take the tone, show your medical 12 authority. Say a lot about statistics and say, well, 13 as a physician, very importantly you must seize 14 opportunities in a polite way. 15 You think that that is consistent with what you 16 saw from Dr. Tollefson. Where every time I would say 17 a question to him, he would say, well, Mr. Vickery, 18 I'm sure you don't understand this. Very 19 condescending, patronizing to suggest that he is the 20 final authority and that we're not smart enough to 21 figure out what they're doing. Seize the 22 opportunities. 23 Now, Mr. See, I have to give him credit, he 24 points out that a year ago I asked Dr. Maris to go to 25 school to help communicate complex scientific stuff to 2676 1 juries better. He wasn't told to ignore the 2 questions. He wasn't told to seize opportunities, to 3 make points. He was told, wear a nice tie, 4 occasionally look at the jury, answer the lawyer's 5 question, and don't use a lot of big scientific words. 6 Put it so we can all understand it. 7 Well, Dr. Thompson got instructions from the PR 8 folks, what if somebody says, isn't it just possible 9 that Prozac causes a few people to commit violent 10 behavior? And he had a script written for him to say, 11 no, Prozac is a safe drug. Safe drug? They just 12 stipulated it is unavoidably unsafe for some people. 13 Because of their disease, some people remain prone to 14 tragic behavior. If we're really pressed, then make 15 the point that there's absolutely no evidence of 16 cause. The script for the defense two years before 17 the Forsyths die. Is that reasonable? That's 18 Exhibit 123, ladies and gentlemen. 19 The following week, Dr. Thompson goes on the 20 20/20 show and he wanted people to know that he did 21 not share the European data at all. All caps. Hum? 22 Wonder why not? That's Exhibit 124. 23 In August 1991 Dr. Healy writes his first 24 article. Dr. Healy has never been involved in a 25 lawsuit. This is before the Forsyths ever die, and 2677 1 he's trying to get the word out. And in October of 2 1991, Lilly prepares a draft for Dr. Beasley, which is 3 ultimately signed that says, well, that item three 4 that we've used to analyze this issue of the Ham-D, 5 it's really not very sensitive, we admit it. And they 6 also said, look at this, akathisia is a subjective 7 phenomena, and hence, you would have to rely on 8 patients volunteering information. 9 You contrast that, if you would, from 10 Exhibit 130, from the little demonstration we saw from 11 Dr. Reus about akathisia. How could that go 12 unrecognized? You don't have to have anybody 13 volunteering that information. This is Eli Lilly 14 that's saying this. 15 Well, Eli Lilly didn't do the rechallenge 16 study. They never did, but Dr. Rothschild did a small 17 one with three patients and all three of them, when 18 they were restarted on Prozac, after a previous 19 suicide attempt, they got suicidal ideation again. 20 When re-exposed, it happened again, akathisia and 21 suicidal ideation. But when they were dechallenged, 22 the feelings went away. 23 Now, finally in January, in the spring of April 24 of 1992, there was some doctors that had some data, we 25 don't know what their data said. We know what it's 2678 1 about. It's about suicide. Dr. Lu and Ko. And Eli 2 Lilly sent somebody on a very important mission. 3 Exhibit 144 shows how that mission succeeded. 4 Mission accomplished. Professor Lu will not present 5 or publish his data, suicidality data. And Lilly's 6 version of this is, well, we were trying to help these 7 Taiwanese guys get published in a scientific journal 8 here in the United States. Well, if that's so, why on 9 earth is the CEO of a company, Vaughn Bryson, getting 10 a copy of this memo? Do you think the CEO of Eli 11 Lilly and Company cared whether some Taiwanese doctors 12 were published in an American journal or not? No, but 13 he does care whether these guys published the 14 suicidality data they had. 15 Eli Lilly spent $2 million to hire these men 16 and tie them up for four or five years. Actually, 17 longer. They are still tied up. All of that happens 18 before March 3 of 1993. All of that shows you what 19 Eli Lilly knew before March 3 of 1993 when the 20 Forsyths die. 21 Ladies and gentlemen, when you consider the 22 documentary evidence of what Eli knew -- Eli Lilly 23 knew, I think you will conclude that they knew that 24 there was a problem, there was a problem about 25 akathisia and suicide and violence and that they 2679 1 failed to warn anybody about it. And that's just not 2 right. 3 What they did do was they reassured doctors and 4 they wrote their script. They wrote their script for 5 the defense. 6 Now, it now becomes my duty to talk to you 7 about what I think you will find to be your hardest 8 task and that is to assess monetary damages in this 9 case. I stand before you on behalf of Bill and Susan 10 Forsyth and I'm going to say it at least two or three 11 times, so there will be no mistaking it. They do not 12 ask for any particular amount of money. That is your 13 job as jurors to determine what is fair and reasonable 14 to them and to Eli Lilly based on all the evidence 15 before you. 16 You see, Bill and Susan's priorities aren't to 17 protect their worldly treasures. That's evident to 18 you from the evidence you've seen. Bill flew all the 19 way to Indianapolis to try to touch the hearts and 20 conscience of people that worked at Eli Lilly by 21 putting a flier on their car. Susan participated in 22 the formation of a non-profit organization to put 23 information on the internet and answer 1-800 calls. 24 That's where their priorities are. And they do not 25 ask for a particular amount of money. 2680 1 But, you know, in this world we don't have 2 magic. I would talk to you of magic and of money. 3 You don't have the power of magic. If you did and you 4 could wave your wand and give them back to us, that 5 would be sufficient for all of us. Even this group of 6 lawyers. But you don't have the power of magic. All 7 that you do have is the power and the obligation under 8 Hawaii law to make an assessment of monetary damages, 9 and I hope that it will be one that is appropriate. 10 Now, what should it be? What are the elements, 11 first of all? Well, the Judge has described many 12 things to you. I think that he could have simply said 13 to you, award damages based on the loss of Forsyth 14 ohana. I think that's what he could have said and 15 probably that would have been as good of instructions, 16 if I understand your concepts. But there are certain 17 things in the law that are required and the Judge 18 detailed them for you; love, affection, loss of 19 companionship, no more bear hugs, no more fishing 20 trips. These people have a permanent loss, and the 21 permanency of their loss is something you should 22 consider in assessing damages in this case. 23 And you should consider the pain and the 24 suffering that Bill and June each went through. June 25 when she awoke to find out that she was being attacked 2681 1 by my Bill. How confused and upset she must have been 2 as she fought for her life and sustained numerous 3 defensive cuts. And how awfully anguished he must 4 have been to realize that his nightmare was reality 5 and to make that decision to take his own life. 6 So what's reasonable? Well, I would expect 7 that Mr. See and Eli Lilly would hope and expect that 8 I would say something to you like ten million dollars 9 for the death of Bill Forsyth, ten million dollars for 10 the death of June Forsyth. And you know what, I've 11 got to tell you, as a lawyer with 27 years of 12 experience, this record before you would justify that. 13 It would justify that. But these people do not ask 14 for a specific amount of money. 15 Let's be fair to everybody. Let's be fair to 16 Eli Lilly. The only thing we know about Eli Lilly is 17 that they spent $2 million to suppress a study or to 18 suppress the publication of data -- 19 MR. SEE: Your Honor, I object -- 20 MR. VICKERY: -- on suicidality. 21 MR. SEE: -- there is no evidence -- 22 THE COURT: Sustained. 23 MR. SEE: -- in this case that says that. 24 THE COURT: Sustained. 25 MR. VICKERY: In the final analysis, ladies and 2682 1 gentlemen, what I hope is that you will render a 2 verdict that will cause somebody on the 12th floor at 3 Eli Lilly to say, when we weigh the economic values of 4 life, we need to take into account that life is 5 precious. How precious is a father? How precious is 6 it to be able to say good-bye to your parents? To 7 look forward to your father walking you down the 8 aisle. How precious is your mother and to have her 9 comfort and her solace when you need it and to be able 10 to say good-bye to her? And what on earth is it like 11 to replace that with the images that have been left 12 for them? 13 Now, we live in a time where people pay 14 $30 million for race horses and $50 million for 15 paintings, and how dear is life in that time? While 16 we've been trying this case, an American pilot went 17 down over Yugoslavia and our country didn't hesitate a 18 minute before they sent in a hundred million dollar 19 jet and several other people to try to save that man's 20 life. That's how precious life is in our society. 21 That's how precious it is. 22 So let's be fair. Let's be fair. Just do what 23 the collective wisdom of the 11 of you says to do. Do 24 justice. And whether when you get to the money, you 25 award $2 million or $20 million or any other number 2683 1 that the 11 of you think is full and fair 2 compensation, because you can't bring them back, but 3 once you say, well, you can't put a value on that, 4 once you say that, then you've just renigged on your 5 oath as jurors because the law requires you to do 6 that. 7 But, folks, I'm not the only officer of the 8 court here. I've given you my thoughts and my 9 reflections. Mr. See is also an officer of the court, 10 and he may have some thoughts for you on the value of 11 human life. I hope he does. Weigh his thoughts. See 12 if he's being fair, if his client is being fair. 13 My clients do ask for one thing from you, from 14 the bottom of their hearts they ask for your verdict. 15 They ask for your verdict. They ask for you to find 16 in their favor, because to do so, will honor and 17 respect their father and their mother who didn't have 18 to die. Thank you. 19 THE COURT: It's 10:30. Let's take a 15-minute 20 break. Please be back at quarter to eleven. 21 (Whereupon, a recess was taken at 10:30 a.m.) 22 THE COURT: Please proceed, Mr. See. 23 MR. SEE: Thank you, Your Honor. May it please 24 the Court, Ms. Forsyth, Mr. Forsyth, Mr. Vickery, 25 ladies and gentlemen, I want to say just to -- at the 2684 1 beginning that I and my client do thank you for your 2 service. Both the parties and the Court have asked 3 you to be here for a long time. It has taken about a 4 month, and it has been my observation that you have 5 been, in my experience, remarkably attentive and 6 there's nothing more that either party or the Court 7 could ask of you than to have done exactly what you 8 have done. 9 This is a marvelous system, and it would not 10 work at all without people like you who are willing to 11 do this and pay such close attention and take your 12 responsibility so seriously, and we do thank you for 13 it. 14 Now, I need to say two things at the beginning. 15 The first one is this: There's no one in this room 16 that doesn't feel natural human emotion about what 17 happened here. Nobody. There's nobody here, 18 excluding anyone, who doesn't feel sympathy for Susan 19 Forsyth and Bill Forsyth, Jr. That is a normal human 20 emotion, and we can't pretend that it isn't here 21 because it is, and it's here in all of us. 22 Now, you heard some testimony that, may have 23 been from witnesses on either side, that we dearly 24 wish that we had treatments that worked for everybody 25 with this disease or any mental disease, and the 2685 1 unkind truth is we don't. We know a lot, but we don't 2 know everything. We don't have medications that can 3 work and prevent tragic events like this in everybody. 4 The medicines we have are pretty good and they 5 work in about 60 or 70 percent of the people, but they 6 don't work for everybody. And that is -- that is a 7 shame, but it's the truth that we have to live with. 8 Now, there's another thing that I want to say, 9 another regrettable aspect of this kind of case, and 10 I'm a lawyer. You know, I get -- this is my job. But 11 it is also regrettable personally that much of the 12 evidence in this case has had to do with the private 13 and deep profound pain that existed in Bill, Sr. and 14 June, his wife. It is regrettable that those kinds of 15 things, their journals, their notes, what they said to 16 their psychiatrists during their times of torment had 17 to be brought out in the courtroom, particularly with 18 their children here, particularly because I think 19 there may have been many of those things their 20 children simply were not aware of, and that is 21 regrettable also. 22 Now, the Court told -- really asked all of you 23 before you became jurors about whether you could sit 24 in this case and be fair to both sides and listen to 25 the evidence and make your decision based upon the 2686 1 evidence and not be swayed by sympathy. Now, I'm 2 talking about this because there's -- one cannot 3 ignore the tragedy of this event and the tragedy for 4 these people, but you all took your oath and 5 Mr. Vickery and I, we also took an oath, that when 6 we're called in this room, we're called to look at the 7 truth the best we can, to put sympathy to one side. 8 If this was a question of sympathy and feeling very 9 sorry about what's happened here, everybody in this 10 room would line up on one side. There would be nobody 11 over on the other side. 12 But you see, that's not the reason we're here. 13 Because we, under the law, must put aside that 14 sympathy and we must, and you must, decide this case 15 based upon the evidence that has been presented. So 16 we have to look at, and have looked at over these 17 weeks, this sort of painful truth about what's 18 happened. 19 And so now, I have a chance, as Mr. Vickery 20 did, to examine with you the truth that has been 21 presented and see where it leads because that's -- 22 we're all sworn to do that. 23 Now, first of all, while the memory is fresh, 24 I'd like to just address a couple of things that 25 Mr. Vickery brought up in his presentation to you. 2687 1 The first thing I would like to address is you will 2 recall that in his summary and also in the blowups, he 3 put up the Exhibit 58 again. That's that preliminary 4 report from Germany back in 1985. It had the 5.6 5 times risk, that sort of thing, you will remember, I 6 know, going through the baseball home run analogy with 7 Dr. Tollefson, that that number, that 5.6, was a raw 8 number. It did not take into account the patient 9 years in the studies. And once you did take that into 10 account, there was no significant difference. 11 And you will also remember that Dr. Tollefson 12 testified all of that data was submitted to the German 13 agency, all of that data was submitted to our FDA here 14 in this country, and the drug was approved in both 15 places. 16 Talking about baseball, I'm kind of set to 17 thinking about if you look at all the documents that 18 Mr. Vickery has put up here and you look at the dates 19 on them, '85, '90, '91 and so on, he's really kind of 20 looking at the second inning or the third inning and 21 saying, well, that's how you tell how the game came 22 out, but that's not how you tell how the game came 23 out. You have to look at the end. So when 24 Mr. Vickery writes up there, as he did in his opening, 25 1985 BGA reject, that's all he told you. 2688 1 Well, in fact, in 1990, after receiving the 2 evidence, after looking at the analysis, the BGA, 3 which is the German agency, of course, approved Prozac 4 and it's approved there today. 5 And let's make no mistake about this business 6 about some suicides being tolerable, and I want to 7 emphasize that. You heard the person that wrote that 8 did not work for Eli Lilly and Company. When that 9 question was put directly to Dr. Tollefson, no death 10 is tolerable? That's ridiculous. It's not worthy of 11 your consideration. Any argument that Eli Lilly 12 believes that suicides or deaths are tolerable is not 13 the evidence. It was not said by anybody working at 14 Lilly. 15 Now, Mr. Vickery also said, and I objected to 16 it, he said Dr. Matthews had said that Prozac caused 17 psychosis in Mr. Forsyth. We've got the advantage of 18 having the transcript from the trial. I just want to 19 remind you exactly what Dr. Matthews said. You all 20 took notes, and you'll remember, but let me just 21 remind you what he said. Question by Mr. Vickery of 22 Dr. Matthews, "Does Prozac cause psychosis?" 23 "ANSWER: Well, there are reports that it has 24 caused psychosis and it would not surprise me in some 25 instances if people became psychotic on Prozac, but I 2689 1 think there's no evidence that Mr. Forsyth was 2 psychotic because of Prozac." 3 Let me remind you what Dr. Neal said on the 4 same topic. This is the doctor that treated 5 Mr. Forsyth in the hospital. The doctor that actually 6 saw him hands-on, interacted with him every day. 7 "QUESTION: Do you believe Bill Forsyth became 8 psychotic? 9 "ANSWER: No, I don't." 10 So I don't think there's any question of 11 psychosis or being psychotic in the case. 12 Mr. Vickery put up some -- I mean -- one more 13 thing about psychosis, he put up in one of his 14 summaries that someone said, well, there have been 15 reports of mania or psychosis and psychosis never got 16 in the insert, never did. That's what Mr. Vickery 17 told you. You will have a copy of the package insert, 18 which is all the instructions that Lilly gives to the 19 doctors and it is Exhibit 2 and you'll see, if you 20 look on the sixth page, under the heading of nervous 21 system. It says, "One of the events that were seen in 22 the controlled-clinical trials was psychosis." So it 23 is in the insert, contrary to what Mr. Vickery said to 24 you. 25 The last thing I want to raise is this: 2690 1 Mr. Vickery again put up the -- a little summary and I 2 think he put up a blowup of the E-mail that Mr. Claude 3 Bouchy wrote back to Lilly saying, well, I don't 4 understand. This is not right. Coding an attempted 5 suicide into depression and how could I explain that 6 to my family and so on? I don't know why he did this 7 again, but he never wants to read to you the response. 8 He just reads the one side. He didn't read the other. 9 The response is Exhibit 1124, and you'll have that and 10 I'll just remind you of what the first part of that 11 says. And you'll remember Mr. Bouchy was saying -- 12 you know, this is not right. How could these coding 13 events in certain ways and doesn't that not look right 14 or get the information in some way we can't retrieve 15 it and so on. 16 Here's the response to Mr. Bouchy, to Claude 17 Bouchy. "This is such a good and important point. 18 That I am hereby asking Bob Zerbe and Alan Weinstein 19 to organize an appropriate group to discuss it. I 20 would very much like to emphasize again that we 21 never," all caps, "diminish information content in a 22 report by deleting any words of the reporter. Never. 23 Ever. The code start" -- that's the name of this 24 coding system -- "the code start classification terms 25 which were invented by and maintained by the FDA, and 2691 1 now required for electronic reporting of ADE, that's 2 these events that they're reporting to the FDA, are 3 just classification terms. They are just pigeon holes 4 in which to file reports so we can retrieve all the 5 ones of a certain time." 6 So that's the explanation, but Mr. Vickery 7 didn't tell you that. You have to see both sides. I 8 think you all need to ask yourself, if you get one 9 document, what was the response? 10 You will recall, I know, the testimony of 11 Dr. Tollefson, all these codes are is simply a way to 12 put it in a computer file. When doctors report 13 adverse events, they could report and I've seen these, 14 for one event, they could say all kinds of different 15 things. If you have a stomach ache, a doctor might 16 say that's a GI upset, gastrointestinal upset. 17 Another doctor might say it's heart burn, another 18 might say you had a belly ache, another might say you 19 had a stomach ache. 20 Now, how are you going to handle that if you 21 are a company that is interested in having a handle on 22 the information? What they do is they make codes, so 23 those different descriptions of the same belly ache 24 can fall into the same bucket with pigeon holes, so if 25 you're searching by computer it's easy to pick those 2692 1 up. That's all it's about. That's the whole thing. 2 Mr. Bouchy did not understand how that system worked 3 and Dr. Thompson explained it to him. That's it. 4 Now, when I gave my opening statement, I told 5 you that this case was about a good drug and that's 6 true, and a very bad disease, major depression. 7 You've heard a lot of evidence about it. I want to go 8 over some of it just to highlight for you what you've 9 heard over the last month. And as I start, I want to 10 say to you that I and Michelle and Ed, we have done 11 our very best to bring to you the evidence in an 12 honest and straightforward way. And I hope we have. 13 You heard evidence about the testing of Prozac. 14 You saw the big chart about how many 15 controlled-clinical trials there were during the 16 1980s. And about the controlled-clinical trials, 17 there's a group given the drug and a group given the 18 placebo, the sugar pill so you can compare so you can 19 tell whether you have a good or bad reaction to the 20 drug. 21 You've heard that Prozac was approved by the 22 Food and Drug Administration in 1987 in the United 23 States. It was first available for marketing in 1988. 24 It has been approved since that day up until this day. 25 Now, I mentioned before Mr. Vickery put up 2693 1 several documents about the by play, the give and take 2 during the approval process for Germany, and again, 3 emphasized all these things that went on in 1985 and 4 so on, and as you know, Prozac was approved by Germany 5 in 1990 and it still is. 6 And I showed you this chart which just 7 summarizes for you, that Prozac is approved in more 8 than 90 countries in the world. You see Germany on 9 there. It still is approved today. So did the German 10 regulatory agency ask questions? Did they ask to have 11 analysis of data? Did they say, gee, this looks 12 funny? Can you explain this for us? Sure. That's 13 what happens in drug approval. And then in the final 14 analysis, all things considered, the drug was 15 approved. Prozac has become the most widely 16 prescribed antidepressant medication in the world. 17 Now, here's another thing to think about and it 18 just struck me last night. Let's go down every doctor 19 that came into the courtroom to testify that said 20 anything about Prozac. We have the treaters, 21 Dr. Neal, Dr. Riggs Roberts; we have the plaintiffs' 22 experts who testified about Prozac, Dr. Shlensky and 23 Dr. Healy; we have defense experts, Dr. Tollefson who 24 was with the company, Dr. Reus, Dr. Matthews, and 25 Dr. Eliashof, the psychiatrist here in Honolulu, what 2694 1 do we know about every one of those doctors that came 2 into this courtroom on both sides of the case? 3 In this case where the claim is that this drug 4 causes people to die, every one of those doctors 5 prescribes Prozac. Every one. The one thing that you 6 all were not asked to do when you came in here is to 7 leave your common sense outside. No instruction tells 8 you to do that. In fact, every one expects, and 9 indeed, the system depends on it, that you brought it 10 in here with you. That the collective wisdom of all 11 of you, with all of your life experience will figure 12 out what's the common sense answer here. 13 You heard a little bit about the development of 14 different antidepressant drugs. First, we had the 15 tricyclic antidepressants. The drug Pamelor that 16 Mr. Forsyth first got, that's a tricyclic 17 antidepressant. Very good, really helped people. 18 About 70 percent of the people with major depression 19 responded well and got help. The problem was it was 20 unpleasant to take, dry mouth, nausea, people didn't 21 like it. And when they didn't like it, they take it. 22 If they didn't take it, it didn't help them. So that 23 was one thing. 24 The other thing was much more serious, and you 25 heard several people testify about this, that those 2695 1 antidepressants, if you take them in overdose, even 2 one prescription worth, they will kill you. So, you 3 know, the doctor was faced with not a very good 4 choice, frankly, a patient with major depression, who 5 may be, in fact, suicidal as part of the disease, 6 provide them medication to help them, and the big 7 risk, suppose they take the overdose because it is 8 very dangerous. 9 This is why drugs like Prozac and drugs in its 10 class called SSRI, and we've heard a lot about that, 11 were such a break through because they're not toxic in 12 overdose. It's very hard to take enough of that kind 13 of drug that would really do you damage in overdose. 14 So a much better deal. 15 However, one thing in common with the other 16 antidepressants, and it is the thing I talked about 17 before, Prozac just like tricyclics, just like every 18 one of the other SSRI antidepressants, Paxil or 19 Zoloft, we've heard they only work about 70 percent of 20 the time. In about 70 percent of the people. So you 21 know, the doctor knows going in, that when you 22 prescribe one, whether it's Pamelor or Prozac or any 23 of them, about a third of the people it isn't going to 24 work. 25 It just -- we don't understand enough about 2696 1 major depression. We don't have a perfect medication. 2 We just have these that are pretty darn good. So you 3 know about a third, 30 percent it's probably not going 4 to work for them. And what happens when it doesn't 5 work? 6 That person with major depression still has 7 major depression, and it is not being treated, and 8 there's always the risk that major depression gets 9 worse and that person with major depression is -- 10 continues to be exposed to the real risk and that is, 11 suicidality. And that's why -- this is probably 12 pretty obvious by now, that's why you have reports of 13 people who have major depression, who take an 14 antidepressant, whether it's Prozac or any of them, 15 because there are case reports about all of them, long 16 before Prozac came along. That's why you have 17 reports, you -- a doctor observes a patient taking an 18 antidepressant, and lo and behold they become 19 suicidal. And so doctors who observed said, well, I 20 gave this medication and then the patient became 21 suicidal. That's a case report. 22 Now, it is important to consider that major 23 depression untreated, unresponsive to medication, is 24 subject not only to the risk of suicide, but severe 25 major depression is also associated with violent acts. 2697 1 And who told us that? This is Dr. Healy. This is the 2 chart I wrote while Dr. Healy was testifying, the 3 plaintiffs' expert. Dr. Healy. He agreed, severe 4 major depression not responsive to treatment is 5 associated not only with suicide, but with violence. 6 Just look at Dr. Shlensky, also the expert for 7 plaintiff, and Dr. Shlensky -- Dr. Shlensky also 8 agreed that it is a recognized concept that sometimes 9 suicidal people will kill other people along with 10 themselves. So that's the risk when you have someone 11 who has a major depression that is not responding to 12 treatment. And everybody agrees on that. 13 Now, we have the report by Dr. Teicher and we 14 heard testimony about that, and what did Dr. Teicher 15 say in the report? Doctor at Harvard, he said, I've 16 got these six patients and I'm observing them and I 17 give them Prozac and they have suicidal thinking. And 18 so he publishes his case report. Now, there's no 19 control group, right? There's no group that he's 20 comparing them to to getting placebo, does this one 21 have more than this one and so on. None of that, case 22 report, but what does that case report do? 23 You know, I don't know, maybe it is the 24 nineties, the media got very interested and there were 25 several case reports saying about the same thing in 2698 1 1990, 1991, all raising the question, as case reports 2 do, well, I gave the patient this medication and I saw 3 that the patient had some suicidal thinking and then 4 what's next? What's next is maybe there's a 5 relationship or maybe we should do a study to see. 6 That's what a case report is. 7 Now, we went through with Dr. Healy his -- the 8 case reports he talked about. He talked about five of 9 them. Here we are, Teicher, King, Wirshing, and 10 Healy, David Healy, his own. Now, even though 11 Dr. Healy said these are controlled-clinical studies, 12 but we read them off, as you may recall, each one says 13 case report. This is not a controlled study. This is 14 Teicher. It says case report. And you remember I 15 read them off with Dr. Healy. They all say case 16 report. Rothschild says case report, which is what 17 they are, not studies. Case reports. 18 And I am not saying to you and none of the 19 witnesses who testified either for the plaintiffs or 20 for Lilly are saying to you those mean nothing. 21 Nobody is suggesting that. But what I am telling you 22 and I believe well substantiated by the witnesses on 23 the stand, the place of case reports in science is to 24 report observations and raise questions, raise 25 questions. Gee, could this be related? Maybe we 2699 1 should do a study to see. That's the place of case 2 reports. 3 First, let me put this up. This is Dr. Healy's 4 article. And then I'm going to go over here and 5 review Dr. Healy's testimony about case reports. Here 6 we are, Dr. Healy. I was making notes while he was 7 testifying, and editing them when Dr. Healy didn't 8 agree, and we talked about case reports. And I asked 9 Dr. Healy, well, what about case reports? There are a 10 number of possibilities because you don't have a 11 control group. There's nothing to compare it to. 12 Either the event could be caused by a drug, that's a 13 possibility, the event could be caused by some other 14 drug, if the patient happens to be taking more than 15 one and you don't know. And if you look at Tiecher's 16 case report, the patient was taking all kinds of 17 different drugs. 18 Another possibility, the event could have been 19 caused by the underlying disease, major depression, 20 suicidality. And another possibility, it could just 21 be a coincidence, that you happen to have taken the 22 drug at a time when the person was going to have the 23 event anyway, and just because the drug was taken 24 before the event occurred, it still could have been a 25 coincident. That's recognized by science. This is 2700 1 Dr. Healy's evaluation of case reports. 2 And then what did he say? When he writes in 3 1994, case reports are clearly an unreliable form of 4 information. This is the plaintiffs' expert, 5 Dr. Healy. So I think that puts case reports in their 6 proper context. They raise scientific questions. 7 They don't provide answers. 8 So what did Lilly do? Mr. Vickery has 9 presented all kinds of documents and he came to the 10 final conclusion Lilly misled everybody. Lilly was 11 dishonest, essentially, is what he was saying, so I 12 want to review what Lilly did. 13 A lot of memos, internal Lilly memos, did 14 people take this seriously? You bet their life they 15 did. In fact, Lilly's probably betting a lot of 16 people's lives that they took it seriously. Were they 17 concerned? You bet. Did they want it looked at? 18 Absolutely, carefully, no holds barred, put a lot of 19 people on it. You get on the plane right now and go 20 see Dr. Teicher in Boston, talk to him, find out what 21 he saw, what's the deal? So what did Lilly do? You 22 heard Dr. Tollefson talk about that. 23 First thing Lilly did was went out and 24 identified who really is an expert in this field, 25 let's bring them in and have them advise us. One of 2701 1 them happened to be Gary Tollefson who was the head of 2 the department of psychiatry at University of 3 Minnesota at the time. So Lilly goes out and asks the 4 experts to come in, and what do they do? They look at 5 their own database, all these clinical trials, to see 6 whether there was more suicide or suicidal thinking 7 with Prozac versus placebo versus the other drug. 8 Not all the studies, they did a meta-analysis, 9 and you heard testimony when you pool all this data, 10 you have to only pool and put together studies that 11 are similar so you can compare apples and apples and 12 they did that and found no increase risk of suicide 13 was apparent in that data. That was one thing Lilly 14 did. 15 I know Mr. Vickery and Dr. Healy complain all 16 about that study in this courtroom. Let's see what 17 Dr. Healy said about that study in 1994 before he gets 18 involved in this case. That was a Beasley study. 19 Let's see what he says. In reply to these case 20 reports, Dr. Beasley scrutinized the database to see 21 about increased suicidality. No such evidence has 22 been found. And what value does Dr. -- did Dr. Healy 23 put on that study at the time? He says, "These data 24 from several thousand patients and the evidence that 25 Fluoxetine reduces suicidal ideation must, on any 2702 1 scientific scale, outweigh the dubious evidence of a 2 handful of case reports." 3 That's what he said in 1994 when he wrote this 4 article to his scientific peers. That's not what he 5 said here, but that's what he said when he published 6 his literature. That was a good way to look at it and 7 really outweighs case reports. 8 MR. VICKERY: Excuse me, Mr. See. Your Honor, 9 I'm going to object to that and ask the jury be 10 instructed to disregard that. This is not in evidence 11 and Mr. See did not cross-examine Dr. Healy about this 12 statement and give him a chance to explain it, so it's 13 argument outside of the evidence. 14 MR. SEE: I beg your pardon, Your Honor. I 15 read -- Dr. Healy read this very statement on the 16 stand. 17 THE COURT: That's my recollection. I'll 18 overrule. 19 MR. VICKERY: I could be wrong. I could have a 20 different recollection. I didn't think he asked 21 him -- 22 THE COURT: Again, I'll defer to the jury's 23 memory of it. 24 MR. SEE: That's one thing Lilly did. 25 Dr. Tollefson testified Lilly also did studies in 2703 1 people who weren't depressed to get the depression 2 part out of the picture, found no increased risk of 3 suicide with Prozac. 4 Dr. Tollefson also testified that Lilly did 5 studies in special high-risk groups and found no 6 increased risk of suicide. There have been, kind of 7 surprised me, 11,500 publications in the scientific 8 and medical literature on Prozac. It surely is one of 9 the most studied and published about substances ever. 10 There is not a single, not one, not one, not a single 11 controlled-clinical trial where you give drug to one 12 group and you give placebo or some comparative 13 antidepressant to another group and compare the 14 results, not one that shows that Prozac has an 15 increased risk of suicide. Not one. Believe me, if 16 there was, you would have heard about it. There's not 17 one. 18 So we have -- and this is done by Lilly. As we 19 know, there have been controlled-clinical trials on 20 Prozac by Lilly's competitors. We heard about one of 21 them. There had been such studies done by independent 22 bodies, National Institute of Mental Health, not a 23 single one shows that. So that's another thing that 24 Lilly looked at, another kind of evidence. 25 I asked Dr. Healy when he gave his testimony 2704 1 about that he had been secretary of the British 2 Association for psychopharmacology and that was a very 3 invitation only group, sort of like the ACNP group in 4 the United States, membership implied a very high 5 expertise in this area, and then I asked him, well, 6 wasn't Professor Stuart Montgomery the president of 7 that group when you were the secretary? Yes, he was. 8 Well, then I asked Dr. Healy about 9 Dr. Montgomery's views. Dr. Montgomery published this 10 article about Reboxetine, which is a competitor 11 antidepressant. Pharmacy and Upjohn Drug. And we 12 read what Dr. Montgomery said, the president of the 13 British association of Psychopharmacology. And he 14 said this: "The risk of suicide and the safety of 15 antidepressants in overdose are of major importance in 16 the management of patients with depression." That's 17 true. "There have been concerns that antidepressants 18 can provoke or worsen suicidal ideation or 19 tendencies." That's the question that was raised by 20 the case reports. That's the question. 21 "It is important to remember, however, that 22 antidepressants will relieve suicidal ideation 23 tendencies in the majority of patients, and" here's 24 the answer, "and there is no clear evidence from 25 clinical trials or from meta-analyses that any 2705 1 antidepressant significantly increases suicide risk." 2 That's Stuart Montgomery. And what's the data he 3 looks at? He looks at controlled-clinical trials and 4 meta-analyses of controlled-clinical trials. 5 He then talks specifically about SSRI drugs. 6 That's the family Prozac belongs to. "SSRIs had been 7 found to reduce suicidal thoughts faster than 8 reference antidepressants, and to protect against the 9 emergence of suicidal thoughts." So that's the 10 president of Dr. Healy's elite psychopharmacology 11 organization in the United Kingdom, Stuart Montgomery. 12 Now, you may recall, I certainly do, Dr. Healy 13 suggesting that Professor Stuart Montgomery had done a 14 study with Prozac and had not published it. Kind of 15 suggesting maybe it didn't work out quite right, was 16 not made public. 17 Well, then we had, during the testimony of 18 Dr. Tollefson, the very study by Professor Stuart 19 Montgomery. And here's what Dr. Montgomery says. 20 This study was not done in people with major 21 depression. It was done to see if Prozac could help 22 people who had something called recurring depression, 23 which is totally a different condition, but here's 24 what he says. "It is clear in this study, 25 Fluoxetine," that's Prozac, "neither increased nor 2706 1 decreased the suicide attempt rate. The absence of 2 provocation of suicidal behavior by Prozac in this 3 group of high-risk patients contradicts the suggestion 4 that had been paid on the basis of anecdotal reports 5 that Prozac provokes suicidal behavior." And what 6 does he cite, Tiecher. He says his data contradicts 7 what Teicher said, and then he goes on and talks about 8 what kind of studies you look at when you want to 9 answer the question. 10 "The high suicide attempt rate observed on 11 placebo," that means a lot of people just getting a 12 sugar pill in this study, "had thoughts about suicide. 13 The high suicide attempt rate observed on placebo, 14 emphasizes the danger of bias in interpreting open 15 report of suicidal behavior in those with a history of 16 suicide attempts, and makes it clear that judgments 17 that particular treatments are likely to cause suicide 18 attempts should only properly be made on the basis of 19 randomized placebo-controlled studies." That's the 20 data you want to look at. That's Dr. Montgomery. 21 So Lilly looked at its own database. Lilly 22 looked at controlled-clinical trials, special 23 populations, non-depressed populations. What else? 24 Epidemiologic studies. You heard that those are the 25 studies of the big groups of people taking different 2707 1 drugs and seeing what happens. And we heard about 2 several of them, and I'll just read exactly what you 3 heard from the stand. 4 The study by Jick, Dr. Healy talks a lot about 5 that study, but during his testimony he never read the 6 actual conclusion. And under the key methods, it 7 says, "The risk of suicide was not determined by the 8 antidepressant prescribed." And in the conclusion 9 here, "Though the suggestion has been made that Prozac 10 may trigger an emotional state, which itself increases 11 the risk of suicide, this suggestion has not been 12 supported by formal opinion." That's the conclusion 13 of the Jick authors themselves based on their data. 14 So there's an epidemiologic study done on patients in 15 the United Kingdom, the authors conclude that it 16 doesn't show that Prozac increases the risk of 17 suicide. 18 We have the physicians survey done by Dr. Fava, 19 and the conclusion of that. "New onset suicidal 20 ideation of the intensity and severity described by 21 Teicher and associates did not emerge in the course of 22 treatment with either Fluoxetine alone or any other 23 antidepressants in our sample of depressed patients." 24 That's the Fava epidemiology type physician survey. 25 Dr. Tollefson told you about the big study paid 2708 1 for by Lilly done in Germany by Dr. Ditman with 2 almost -- I don't know, how many patients did it have? 3 I can't add this. Eighteen thousand some odd. And 4 Dr. Tollefson gave his testimony about what that 5 shows. "The incidents of the risk of suicide 6 decreased as the severity of the depression decreased 7 with Prozac treatment." 8 We then have the, I said it was Fiona Mackay 9 and Dr. Healy corrected me, Fiona Mackay. This is the 10 study, epidemiology study done in Dr. Healy's own 11 country, United Kingdom, by the Drug Safety Research 12 Unit. And in that study, the difference between the 13 number of suicides with each of the four SSRIs was not 14 statistically significant. No deaths in these studies 15 was attributed to an SSRI. And then there's a 16 conclusion. Remember this is the Drug Safety Research 17 Unit of the United Kingdom. "There was no statistical 18 significance between the number of suicides and the 19 SSRI taken. It has been suggested that Fluoxetine 20 might promote suicidal ideation." And what's cited 21 there? Teicher. And then question, "Our data do not 22 support this view." There's another big epidemiology 23 study, "No increased risk with Prozac." 24 We've got only two more to talk about. This 25 one by Dr. Leon, these were the two studies that were 2709 1 prospective in nature, that actually didn't look in 2 the past, but followed a group of people as they went 3 on living their lives. The testimony is the real 4 world stuff. This is not academic, ivory tower, 5 isolated. Real world. 6 "The results indicate that although Prozac was 7 prescribed to more severely ill subjects; that is, the 8 people in this group that were just observing, the 9 people who got Prozac were actually sicker before they 10 got the drug." So Prozac was being given to people 11 who had worse depression. "Their risk of suicidal 12 behavior was not elevated. Instead, they were 13 non-significant protective effects of Fluoxetine, 14 Prozac, and other somatic antidepressant treatment in 15 the absence of Fluoxetine." So not only did it not go 16 up, it actually went down a little bit. 17 And the conclusion, "Despite the greater 18 severity and suicidality before the use of Prozac, 19 suicidal behavior did not increase with the use of 20 Fluoxetine." So there we have the Leon study, another 21 big epidemiology study. 22 And the last one I'll talk about is the Warshaw 23 study. Conclusion, this is another one of these 24 prospective studies, where you follow a bunch of 25 people over time and see what some of their doctors 2710 1 give them Prozac and some of their doctors give them 2 something else, and you group those together and see 3 what happens to them over time. It's called 4 naturalistic, very real world. 5 Conclusion, "We found no evidence that Prozac 6 was associated with increased risk of suicide attempts 7 or gestures." I think we even blew up -- we even blew 8 that one up. That was the conclusion. No evidence 9 associated with increased risk of attempts or 10 gestures. And, in fact, they found there was a 11 significantly lowered probability of suicide attempts 12 in patients with both anxiety disorder and a 13 depressive disorder who had received Fluoxetine 14 compared with those who did not. 15 Now, why is this part applicable to this case? 16 Because Bill Forsyth had major depression plus 17 terrible anxiety. He had both. And that's what this 18 study looked at, people with both. Lower probability 19 of suicide attempts in people who had both. 20 Now, that's the data that was presented in this 21 case about whether the scientists have found the 22 answer to the question whether -- is there an 23 increased risk of suicide or violent act with Prozac? 24 Those are the studies. Now, what had been the 25 conclusions? You know, you'll remember, we went round 2711 1 and round about this. Mr. Vickery doesn't like the 2 Harvard Mental Health letter and I presume he doesn't 3 like it because that's where Dr. Teicher comes from, 4 the Harvard Medical School. 5 And what the Harvard Mental Health letter from 6 the Harvard Medical School says, and this is January 7 of '95, '95; "On the other hand, critics have also 8 claimed that Prozac causes suicide. The evidence 9 against that claim is strong. Antidepressant drugs in 10 general, as one would expect, reduce the danger of 11 suicide and SSRIs are no exception." That's the 12 Harvard Medical School. 13 And then, finally, you heard about the American 14 College of Neuropsychopharmacology, ACNP, long name. 15 But what you heard about it is it is the top 16 organization, scientific group, in this country of 17 people who have the most expertise in this area. 18 Invitation only. Dr. Tollefson from Eli Lilly is a 19 member of this group. And they issued a consensus 20 statement in March of '92, and they talked about these 21 case reports, what do they all mean? What are we to 22 talk about this? Here's what they said: "In 23 conclusion, case reports suggest that a small minority 24 of patients may experience emergent suicidal thoughts 25 or event such behavior during the pharmacological 2712 1 treatment of depression. People who are depressed 2 while they are taking antidepressants might have," and 3 they go on. 4 "These reports do not distinguish between the 5 relative contribution of the disease, external 6 stressors, or the medication." They're saying you 7 can't tell from case reports. "Of significance, there 8 is evidence that such emergent suicidality is not 9 specific to any one kind of antidepressant and may, 10 therefore, be largely a manifestation of the natural 11 course of the illness." That's not me saying that. 12 That's the ACNP saying that. 13 They conclude, this is the top, top scientific 14 organization in this country, about drugs used for 15 psychiatric illness. "There is no evidence that 16 antidepressants, such as the selective serotonin 17 reuptake inhibitors, SSRI, for example, Prozac, 18 trigger emergent suicidal ideation over and above 19 rates that may be associated with depression and other 20 antidepressants. What is clear is that most patients 21 receive substantial benefit from treatment with this 22 drug, Prozac, and related antidepressants." That's 23 the conclusion in 1992. 24 Now, the judge has instructed you about the 25 Food and Drug Administration. And the Food and Drug 2713 1 Administration also was involved, as you heard, 2 questioning back and forth, what about this? What 3 about the data? Do this, do that. And here's the 4 first conclusion by the FDA. This is in July of 1990, 5 and the FDA says, well, what is this case report by 6 Teicher and these other case reports, what does it 7 mean? They say the Prozac label has always warned the 8 general risk of suicide in depressed patients and 9 recommended close supervision of high-risk patients. 10 Prozac labeling has always done that. 11 "On the evidence currently available, there 12 appears to be no basis to conclude that the use of 13 Prozac is associated with any unreasonable or 14 unexpected risk." That's the FDA. That's their first 15 conclusion. 16 Then we go down the road about a year, July of 17 '91, and what do they say? "The data and information 18 available at this time do not indicate that Prozac 19 causes suicidality or violent behavior." Official 20 conclusion by the FDA. 21 And here's one more, and now we're at August of 22 '91. This is when the Church of Scientology kind of 23 went after Prozac and asked the FDA to take it off the 24 market and that sort of thing, and this is the FDA's 25 response back to that. And they say, same thing as 2714 1 the last one, "Data available do not indicate that 2 Prozac causes suicidality or violent behavior. The 3 FDA reveals no basis for concluding that Prozac causes 4 these adverse events. Depression itself is highly 5 associated with suicide." 6 And what do they do? An analysis of 7 controlled-clinical trials. That's the data that the 8 experts look at. That's the data the FDA looks at 9 when they want to answer the question. Allow the 10 direct comparison between Prozac, placebo, or other 11 antidepressants failed to find any greater risks among 12 those on Prozac. 13 Now, there's one more and if you're taking 14 notes, I didn't blow this one up, and I apologize. 15 It's Exhibit 1049, and it's a letter from the FDA and 16 it's dated June the 3rd of 1992. And again, the FDA 17 is responding to a suggestion or request that Prozac 18 have some different warning and here's what they say. 19 The request was that there -- that Prozac include a 20 boxed warning, a warning with a box around it. You 21 may have heard Mr. Vickery talk about that earlier. 22 That's what this 1049 requested, a boxed warning. 23 "Regarding the association of Prozac with 24 intense violent suicidal preoccupation, agitation and 25 impulsivity in a small minority of patients." That 2715 1 was the request. Here's what the FDA said. "We have 2 reviewed your citizen petition and evaluated all 3 currently available relevant evidence. Because this 4 evidence is not sufficient to reasonably conclude that 5 the use of Prozac is possibly associated with suicidal 6 ideation and behavior, we are denying your request." 7 So in this one, the FDA is saying we've looked 8 at all of this data and we can't conclude that the use 9 of Prozac is even possibly associated. They 10 specifically talk about Teicher case report and that 11 sort of thing. So that's at 1049 in the exhibits that 12 you'll get. That's the FDA's conclusion in '92. 13 Could all this be true? If, as Dr. Healy says, 14 Prozac causes, I don't even remember what it was, 20, 15 25 times more suicide, could all this be true if that 16 were so? That's the common sense question that you 17 really are being asked. 18 Now, we need to talk about the package insert, 19 which is the instructions, warnings, and so on that 20 Lilly provides to the prescribing doctors. And the 21 Court read you -- well, first of all, the Court read 22 you Instruction 14, and Mr. Vickery has made reference 23 to it. It's about Prozac being unavoidably unsafe. 24 That's why it is a prescription drug, because all 25 prescription drugs have risks. That's why you can't 2716 1 go and buy it over-the-counter and I can't go and buy 2 it over-the-counter. It has risks. Just like all the 3 other antidepressants have risks. The TCAs have a big 4 risk. If you take too many, you'll die. All 5 prescription drugs are in that category. They have 6 risks. But because they can do so much good, we don't 7 say that they are defective because they have risks. 8 We just have to have instructed the physician to be 9 aware of what the risks are so that the doctor then 10 can make a judgment. 11 And you heard several of the doctors testify, 12 well, sure before I prescribe any drug, I take into 13 account the potential benefit for the patient and the 14 potential risks, and I don't give any drug unless I'm 15 convinced that the benefits outweigh the risk. That's 16 what prescribing medicine is all about. 17 So that's the unavoidably unsafe part of it. 18 It doesn't mean that this stuff is dangerous. It's 19 bad, get it off the market. All it means is it is a 20 prescription drug and when you read Instruction 14, 21 you will see that. They're just talking about 22 prescription drugs. 23 Now, Instruction 13 is the instruction that 24 talks about these warnings of risk. A prescription 25 drug is defective under the law, as the instruction 2717 1 says, if the warnings, the instructions, the 2 information given to the doctors is not adequate to 3 tell the doctors about risks that were known or 4 knowable in light of the best scientific and medical 5 knowledge available at the time of the manufacturer 6 distribution. So we've got to go back to 1992 and 7 1993, February and March of '93. That's the time. 8 So we have to look at risks that were known or 9 knowable. In other words, what did science know at 10 that time? That's the deal. That's the shorthand way 11 of saying it, and you had to bring that to the 12 doctor's attention to have an adequate warning, and if 13 you did that, the drug is not defective. That's what 14 the instruction says. So let's look at this. 15 First, the insert warns about suicide and it 16 tells the doctor that the possibility of a suicide 17 attempt is inherent in depression. They probably 18 already know that as we heard our doctors say they 19 knew that. This is important in the next part, "And 20 may persist until significant remission occurs." And 21 that risk of suicide may stay around for a while until 22 the depression, you have significant remission, that's 23 the warning Lilly gave. 24 Close supervision of high-risk patients should 25 accompany the initial drug therapy. Watch them 2718 1 closely if they have a high risk of suicide. Lilly 2 says to the doctors, if you use this in combination 3 with other CNS active drugs, caution is advised. 4 Caution is advised. 5 And now, specifically, I want to take you back 6 to the testimony of Dr. Shlensky. What did 7 Dr. Shlensky say? What was his criticism of this 8 insert? Again, I've got the benefit of the 9 transcript. What is it that he complained about? He 10 said this: "What are your opinions about the 11 information that they put out for prescribing doctors 12 about these issues?" And here's what he said. "Well, 13 the information that was provided to prescribing 14 physicians in the so-called package insert in the 15 Physicians Desk Reference," that's just the big book 16 that has all of these in it, at the time; that is, in 17 1993, here's the language. This is the complaint by 18 Dr. Shlensky, "It did not raise the issue of potential 19 suicide and violence." That it did not raise the 20 issue of the potential -- of potential suicide and 21 violence. That's Dr. Shlensky's complaint. 22 And I tell you, search your memory, Dr. Healy 23 gave no criticism of the insert. That's the only 24 criticism from the plaintiffs' experts. That's it. 25 That it did not raise the potential for violence or 2719 1 suicide. 2 In the section called post-introduction 3 reports, you know what those are? Case reports. It 4 says, "Voluntary reports of adverse events temporally 5 associated with Prozac." We've heard that term. It 6 means, you took the drug and the event happened at the 7 same time. It happened while you were taking the 8 drug -- "had been received since market introduction 9 and may have no causal relationship with the drug" -- 10 remember what Dr. Healy says about case reports. They 11 may have no causal relation with the drug -- "include 12 the following:" And here's what Lilly told the 13 prescribing doctors, "those kinds of reports we 14 received that you ought to know about, include 15 suicidal ideation, that's suicidal thinking, and it 16 includes violent behaviors." So did Lilly raise the 17 issue of potential suicide and violence in 1993 in 18 February? Yes. 19 Now, as the case has worn on, it has become 20 apparent, although Dr. Shlensky made no criticism 21 about akathisia, he didn't say anything about it, we 22 blew this up, other events during premarketing 23 evaluation of Prozac. These were the adverse events 24 that were seen actually in the clinical trials. We 25 saw this, this occurred, and what does Lilly tell the 2720 1 doctors? We saw agitation and we saw akathisia. 2 Any doctor that read this insert that was 3 provided was informed, warned by Lilly, that in people 4 taking this drug -- now, remember go back to February 5 of '93, that's the time we're talking about, it had 6 been reported that people taking this drug had had 7 agitation, had had akathisia, it had reports of people 8 having suicidal ideation, and it had reports of people 9 having violent behaviors. That information was 10 provided to the doctors along with this general 11 warning. Don't forget now, if you're treating 12 depressed patients, the possibility of suicide is 13 always there. So that's the package insert. 14 THE COURT: Excuse me, Mr. See. I'd like to 15 meet with counsel at side bar. 16 MR. SEE: Surely. 17 (Whereupon, the following proceedings were had 18 at side bar out of the hearing of the jury.) 19 THE COURT: I assume you have a while to go? 20 MR. SEE: A little bit. 21 THE COURT: Like what? 22 MR. SEE: Say, 45 minutes. 23 THE COURT: Okay. I think we better break for 24 lunch then. 25 MR. SEE: Okay. 2721 1 THE COURT: Sorry. Come back at one o'clock? 2 MR. VICKERY: Okay. That would be fine. 3 (Whereupon, the following proceedings were had 4 in open court in the presence of the jury.) 5 THE COURT: It's twelve o'clock, so I think we 6 better break for lunch now. Please be back at one 7 o'clock. 8 (Whereupon, a lunch recess was taken at 9 12:00 p.m.) 10 THE COURT: Please proceed, Mr. See. 11 MR. SEE: Thank you, Your Honor. Ladies and 12 gentlemen, let me put the package insert up for one 13 more second. Let's talk about one more thing. I 14 suspect that when Mr. Vickery gets up, he gets to get 15 up and give another argument after I finish, that he 16 will say this, he will say, well, this is not a 17 warning. This right here, this is not a warning 18 because it's not up here in the warning section in the 19 insert. There's a section of the insert called 20 warning, and because this is not up there in that 21 warning section, it's not a warning. 22 The thing is this, you heard read to you during 23 the testimony of Dr. Tollefson the federal regulation 24 that governs what goes in that warning section and 25 what it says is there has to be reasonable evidence of 2722 1 an association between the drug and the adverse event, 2 reasonable evidence of an association. Exhibit 1049, 3 that we just talked about, this is the FDA's June 3, 4 1992 decision, they say, "Because the evidence is not 5 sufficient to reasonably conclude that the use of 6 Prozac is possibly associated with suicidal ideation 7 and behavior, suicidality, we are denying your 8 request." 9 So there, right there the FDA is saying there 10 is no evidence, reasonable evidence of an association, 11 so it doesn't have to go up there. So I submit to you 12 in the circumstances where what you have is case 13 reports that raise a question, where you have the 14 federal regulation that says in order to go up here in 15 the warnings it has to be reasonable evidence of an 16 association. The FDA says there is no such evidence. 17 And Dr. Eliashof has said -- now, this gives you a 18 warning. This tells you these events have been 19 reported and puts you on notice, so it doesn't have to 20 be in the warning section, and in fact, the FDA has 21 specifically ruled that it's not appropriate to put 22 that in the warning section. I just want to cover 23 that because I would suspect that that may come up. 24 Now, there's one more thing about the warning 25 aspect of the case that I want to talk to you about. 2723 1 You've heard reference to Exhibit 22, that's the 2 dear-doctor letter, and you've heard that in August of 3 1990, Eli Lilly, on its own, nobody made it do this -- 4 fDA did not order Lilly to do this -- sent out this 5 letter to every doctor in the United States. And what 6 this letter did was it told the doctors specifically 7 about the Teicher article. A recent 1990 report of a 8 series of six clinical cases of patients with 9 refractory or chronic depression and complicated 10 psychiatric histories raised the possibility that 11 Fluoxetine therapy may induce suicidal ideation. 12 So Lilly is telling every doctor in the United 13 States, this article came out and you ought to know 14 about it. Now, Mr. Vickery kind of says this is no 15 good. Not any kind of warning. Not any kind of 16 putting doctors on notice of something they ought to 17 take care about, be aware of. Well, you'll get it and 18 you take a look at it if you have a question about it, 19 see what Lilly said to the doctors, see if you don't 20 conclude that Lilly, in a straightforward and honest 21 way, told the doctors here's the evidence that we have 22 right now. Here's what we think it means, but you 23 ought to be aware of it. And it also has this 24 particular sentence. See if you don't think this was 25 a reasonable thing to do by Lilly. "When using any 2724 1 antidepressant therapy, clinicians must remain 2 vigilant for direct or indirect communication of 3 suicidality, including emergence or changes in 4 intensity of suicidal thoughts in order to take 5 appropriate clinical action." 6 So Lilly specifically tells the doctors, you be 7 aware, you remain vigilant when you give people 8 antidepressants, including Prozac, there could be 9 suicidality and you need to be aware of it and be on 10 guard about it. That's the dear-doctor letter, 11 Exhibit 22. 12 Now, that's the issue of the warnings, did 13 Lilly provide adequate warnings of these risks that 14 the plaintiffs say ought to have been warned about, 15 and I submit to you the answer to that is yes. 16 Now, there's another aspect of it. Did the 17 warnings -- what effect did they have on this case, on 18 these doctors. You'll remember, Dr. Roberts, he gave 19 very clear testimony. Had he read the Prozac insert? 20 Yes, he had. Did he always take in account the 21 potential benefits and the potential risks? Yes, he 22 did. He didn't prescribe unless the benefits 23 outweighed the risk, and he also said this, "When I 24 prescribe antidepressants, I have in mind that my 25 patient with depression could already be suicidal." 2725 1 He's already thinking about that, and he also said, 2 "During treatment with antidepressants, I always have 3 in mind that suicide could emerge or could worsen." 4 And he also said, and you know what, "I also consider 5 the risk of homicide." So Dr. Roberts had all this in 6 mind when he prescribed Prozac for Mr. Forsyth. 7 He was also very clear about this. "I went to 8 Harvard Medical School," this is Dr. Roberts. "I was 9 trained there not to rely on the drug company 10 information. I was trained to do my own research, to 11 read the journals myself, to go to meetings myself and 12 get my own information." And what does he say? He 13 said, "The information that I rely upon for my 14 prescribing decisions is published controlled-clinical 15 trials." So that's what he relies upon. 16 And then we had Dr. Neal and Dr. Neal also 17 continued the prescription for Mr. Forsyth, and his 18 testimony is also very clear on this. You'll remember 19 there was testimony that Mr. Vickery sent Dr. Neal a 20 bunch of exhibits from this case and then went to 21 visit him in his office, and this was the question: 22 "Now, the question I have for you, Dr. Neal, is after 23 having reviewed those materials" -- Mr. Vickery 24 described them as exhibits in this case, including the 25 article by Dr. Healy -- "if you had known what was 2726 1 contained in those materials, including Dr. Healy's 2 article, if you had known all of that in February of 3 1993, would that have caused you not to prescribe 4 Prozac to William Forsyth?" And the answer, "I don't 5 believe it would have." So that was Dr. Neal's take. 6 He says on the next page, "If you had known all 7 these things contained in the materials Mr. Vickery 8 sent you, would you have treated Mr. Forsyth 9 differently than you did in February and early March 10 of 1993? 11 "ANSWER: No. I would not." 12 So Dr. Neal would have treated Mr. Forsyth in 13 the same way. 14 Now, that's the warning issue, so I'm going to 15 take this down and put it over here and put that to 16 bed. And the next issue I want to talk about is 17 akathisia. Two questions about akathisia; what is it 18 and did Bill Forsyth have it? Two questions. 19 Now, we have a number of sources we could turn 20 to on the first one, what is it? First, let's turn to 21 the plaintiffs' expert, Dr. Shlensky. This is his 22 testimony about what akathisia is. "It is a restless 23 state. People have trouble sitting still. They pace. 24 They may wring their hands. Very uncomfortable 25 emotionally." So you can see Dr. Shlensky says 2727 1 akathisia is both a restless state and he said, motor, 2 you pace, you may wring your hands, you may have 3 trouble sitting still, so he has both, the objective 4 and the subjective motor symptoms. That's akathisia 5 according to Dr. Shlensky, the plaintiffs' expert. 6 You'll recall that when Dr. Reus was up here 7 testifying, he had an article written by a fellow from 8 the Pfizer company which talked about akathisia and we 9 came back and actually read the definition of 10 akathisia in that very article, and this is the 11 article used by Mr. Vickery, and it says, "Akathisia, 12 a syndrome characterized by an inner sense of 13 restlessness, one, and an inability to sit or stand 14 still." So that's the definition in the article that 15 Mr. Vickery used, same thing that Dr. Shlensky said. 16 And during Dr. Reus' testimony, we looked at 17 the DSM-IV, which is the diagnostic manual put out by 18 the American Psychiatric Association. And it defined 19 akathisia in exactly the same way. A subjective 20 complaint of restlessness and at least one of these: 21 Fidgety, swinging legs, rocking from foot to foot 22 while standing, pacing, or inability to sit or stand 23 still. 24 So I would suggest to you that those are 25 definitions all consistent from pretty good sources. 2728 1 Two of them come from the plaintiffs; the Lane article 2 and Dr. Shlensky, and the DSM-IV is the Bible of 3 diagnosing psychiatric diseases in this country. So 4 akathisia is having an inner subjective sense of 5 restlessness and having motor symptoms that you can 6 see; pacing, can't sit still, can't sit down, that 7 kind of thing. 8 Now, the second question is, did Mr. Forsyth 9 have it? Did he have that condition while he was 10 taking Prozac? I'll put up the chart that I kept 11 during the testimony of Mr. Bill Forsyth. And I 12 recorded while Mr. Forsyth gave his testimony, his 13 observations about what his dad looked like during the 14 time he was taking Prozac, and you'll recall on the 15 23rd when his dad came over to his home, he seemed 16 pretty good. No description of agitation or pacing or 17 anything like that. 18 Now, this is -- the 24th is the day he actually 19 wanted to go to the hospital, and you'll recall 20 Mr. Forsyth first said he thought his dad had a panic 21 attack, but then it passed and he was quiet, calm, 22 wasn't jumping around. This was in the taxi on the 23 way to the airport. This was flying over here to Oahu 24 to go to the hospital. Then Mr. Forsyth visited his 25 father on the 27th and 28th, all this time on Prozac, 2729 1 quiet and calm. And then seeing him the evening of 2 March the 3rd, still, all the time, Mr. Forsyth is on 3 Prozac. He's calm. He was sitting on the sofa. He 4 was not pacing. He had a subdued demeanor, nothing 5 drastically wrong. Those are the descriptions we have 6 of how Mr. Forsyth appeared during the time that he 7 was taking Prozac. 8 You will get the Castle Medical Center records, 9 and I will tell you in the Castle Medical Center 10 records there is no entry that this man had akathisia. 11 There is no entry that this man had agitation during 12 any time he was taking Prozac. There was no entry 13 that he was pacing, that he was hand-wringing, that he 14 couldn't sit down, that he was foot tapping or moving 15 back and forth. Nothing like that. 16 And in particular, let's look at what Dr. Neal 17 testified about on that topic. This is Dr. Neal's 18 testimony during this trial. And first I asked him, 19 you know, how he was tapering him off the Xanax, 20 because he didn't like taking that drug, and I asked 21 him, "When you take a person off of a drug like that, 22 do you watch him carefully to see whether he had any 23 symptoms or withdrawal or anything?" 24 He said, "Yeah, that's right." 25 I said, "You watched him pretty carefully to 2730 1 see if he had any drug-related symptoms?" 2 "Yes, that's right." 3 Then he said this, I asked, "Your interviews 4 with Mr. Forsyth, did you actually inquire about 5 whether he was having subjective feelings of 6 restlessness?" That's the first part. "I don't 7 remember asking specifically, but that's ordinarily 8 part of the questioning." 9 "So according to usual practice then, at that 10 time you would have asked him?" And he said, "Yes, I 11 would. 12 "QUESTION: Whether he was feeling subjective 13 feelings of restlessness?" And the answer was "Yes." 14 "And if he would have reported that to you, is 15 that something that you would have written in the 16 chart?" 17 "Yes, I would." 18 "And is there any entry in the chart that 19 Mr. Forsyth, in response to questions, was feeling any 20 subjective feeling of restlessness?" 21 "ANSWER: No." 22 So think about it. Even if -- even if you 23 would follow Dr. Healy and say you don't need any of 24 this, you don't need to see it. You could have 25 invisible akathisia. I don't think that's right, and 2731 1 I don't think any of these definitions say that's 2 right, but assume that's right. You're looking for 3 the inner sense of restlessness. Dr. Healy even said, 4 you know, patients have to be questioned about that. 5 They might not report it to you. 6 Well, according to Dr. Neal's practice, he did 7 question Mr. Forsyth about that, and there was no 8 indication that Mr. Forsyth was having any subjective 9 feeling of restlessness, so even as to the first 10 point, we have no evidence that shows that 11 Mr. Forsyth, in fact, had that feeling. 12 Here's some more of Dr. Neal's testimony in 13 this case. 14 "During your observation of Mr. Forsyth during 15 all the time he was in the hospital taking Prozac, was 16 there any indication he was having any kind of side 17 effect or adverse reaction to Prozac?" 18 "ANSWER: There was not. No side effect or 19 adverse reaction." 20 "Based upon your observation during all the 21 time he was taking Prozac, is there any evidence that 22 Prozac caused Mr. Forsyth to have suicidal ideation, 23 suicidal thinking?" 24 "ANSWER: No." 25 "Was there any evidence or any symptom that 2732 1 Mr. Forsyth became agitated?" 2 If you remember, one of those articles said, 3 well, you might confuse akathisia for agitated 4 depression, so I asked him, "Any symptom or sign he 5 became agitated?" Answer to that, "No." 6 "Any evidence or sign that Prozac caused 7 Mr. Forsyth -- that Prozac caused Mr. Forsyth to 8 become agitated?" 9 And the answer to that, "No." 10 Now, here, again, "During his entire time of 11 hospitalization at Castle, was there any evidence, any 12 sign, any symptom that Prozac caused Mr. Forsyth to 13 have akathisia?" 14 "ANSWER: No." 15 Now, I'm going to suggest to you that this is 16 the doctor right here, who's -- he was the fellow that 17 was there. None of these other people were there. 18 Dr. Neal was there, saw Mr. Forsyth every day. No 19 sign of akathisia. 20 Just to finish this out. "During your 21 psychiatric evaluation and interaction and 22 observation, is there any evidence that Prozac caused 23 Mr. Forsyth to have homicidal ideation?" 24 "No." 25 "Any evidence that Prozac caused Mr. Forsyth to 2733 1 become violent or physically assaultive?" Remember he 2 was in the hospital for seven or eight days taking 3 Prozac. 4 "ANSWER: No." 5 "During that time, was there any evidence that 6 Prozac caused him to have panic attacks?" You 7 remember he had panic attacks before he ever started 8 taking Prozac, and his answer, "Prozac made him have 9 panic attacks? No." 10 "Any evidence that Prozac caused him to 11 physically attack other people?" 12 "No." 13 "Any evidence while he was at Castle that 14 Prozac caused his depression to get worse?" 15 "No. No evidence of that." 16 "Any evidence while he was taking Prozac at 17 Castle that caused his anxiety to get worse?" 18 "No. No evidence of that." 19 So, you know, we've got both the records that 20 have absolutely no entry of any kind of either the 21 subjective inner sense of restlessness, and Dr. Neal 22 asked him, no entry like that. No entry of the 23 physical symptom. Here's the doctor that treated him, 24 no symptom of akathisia, no symptom of agitation. 25 So during the entire time he was at Castle, 2734 1 24th of February to March the 3rd, nothing that would 2 suggest akathisia. No diagnosis and no symptoms. 3 Here's this question put to Dr. Neal during his 4 testimony here at trial. 5 "Okay. Is -- did you ever question Bill 6 Forsyth specifically looking for akathisia? 7 "ANSWER: Yes. 8 "QUESTION: Okay. What do you recall him 9 saying? 10 "ANSWER: He had anxiety, but he didn't have 11 any sort of restless feeling, any feeling that he 12 needed to move around or pace or any of those things 13 that are symptoms of akathisia." 14 Again, there's no indication, even upon 15 questioning, that Mr. Forsyth had akathisia during the 16 time he was taking Prozac. 17 Now, you recall that Mr. Forsyth's wife, 18 Mrs. Kim Forsyth, testified and she testified about 19 seeing her father-in-law on the 24th of February, and 20 Mr. Burke questioned her and he had to bring out her 21 deposition that I took three years ago, and at her 22 deposition three years ago when I asked her about this 23 day, February 24th, this is the question, now, this is 24 an open-ended question: 25 "QUESTION: How did Mr. Forsyth appear to you? 2735 1 "ANSWER: Let's see. He appeared very sedate, 2 somewhat quiet, and that's all." 3 I submit that the testimony from Mrs. Kim 4 Forsyth that is worthy of your consideration is the 5 testimony she gave at her deposition three years ago 6 where she said that she saw her father-in-law, he 7 appeared sedate and quiet and that's all. 8 Now, there is one thing that I do want to 9 mention, need to mention. We've seen that all the 10 time that Mr. Forsyth was taking Prozac, he's 11 described as being quiet and calm and so on. Now, you 12 will remember when Mr. Forsyth was -- I beg your 13 pardon, when Mr. Vickery was examining Dr. Neal, and 14 then I got up and I asked Dr. Neal some questions, and 15 after Dr. Neal gave his testimony, Mr. Vickery got 16 back up again and he kind of raised his voice at 17 Dr. Neal, and he said, have you been threatened? You 18 will recall that, and I think Mr. Vickery's 19 implication was that Dr. Neal had maybe fudged and not 20 written the right thing in his discharge report from 21 Castle Medical Center because it had been dictated 22 some 20 days or so after the discharge. 23 Now, what I want to read to you is what 24 Dr. Neal told the Maui Police right after this 25 happened. This happened on the third, actually 2736 1 discovered, I guess, on the fourth, and the police 2 came and talked with Dr. Neal on the telephone on the 3 eighth. It's right after this happened. And what 4 you'll hear is Dr. Neal told the Maui Police exactly 5 the same thing that he wrote in his discharge summary. 6 This is -- the police report is Exhibit 165, 7 and this particular entry is on Page 20. He says -- 8 this is Dr. Neal. "Mr. Forsyth had wanted to return 9 to Maui immediately. He said that his son was trying 10 to gain control of his assets. He was very upset that 11 his son was trying to make financial decisions with 12 his assets. He felt that his son was not capable of 13 making sound financial decisions. Continued to say 14 that Mr. Forsyth and his son had disagreements over 15 money. Then said that Mr. Forsyth was a very peaceful 16 man." 17 So I just want you to know that, although 18 Mr. Vickery asked Dr. Neal if he had been threatened 19 to change his testimony or whatever, Dr. Neal told the 20 Maui Police exactly the same thing right after it 21 happened. 22 Now, I want to talk about the opinions of 23 Dr. Healy and Dr. Shlensky. Dr. Healy's opinion and 24 Dr. Shlensky's opinion really work the same way. They 25 depend on akathisia. They both say Prozac caused 2737 1 akathisia in Mr. Forsyth and that caused Mr. Forsyth 2 to be so uncomfortable that he committed these 3 suicidal and homicidal acts. Those are their 4 opinions. If you don't have akathisia, their opinions 5 don't stand up because that's the way they get there. 6 But let's look. 7 Here's what Dr. Healy said and you'll remember 8 I wrote down some notes as we were going along. He 9 said that Bill Forsyth's notes, you remember seeing 10 those? We'll look at them briefly again. To him, 11 those were just normal jottings. Well, I think that's 12 just wrong. You'll remember them when you see them. 13 With Mrs. Forsyth, Dr. Healy said she had no 14 psychiatric condition. That's just wrong. He said 15 that Mr. Forsyth did not have a controlling 16 personality. That's not consistent with the evidence 17 we've heard. 18 He thought this religious issue was not an 19 abnormal stressor on Mr. Forsyth. We probably 20 disagree about that. That June's changing role in the 21 marriage was not an abnormal stressor on the marriage. 22 Asked him about a personality change, and you'll 23 remember the testimony from his family members, and in 24 fact, he had a personality change. Dr. Healy didn't 25 think so, no abnormal change. And did he have a 2738 1 worried, panicky nature? Well, we couldn't agree on 2 that one. 3 Did he have signs of paranoia before he took 4 Prozac? Dr. Healy said no. Well, other people said, 5 yeah, maybe he did. Dr. Healy agreed that Mr. Forsyth 6 said that he felt that he lost control of his life. 7 Spending more time at home was a stressor, yes, but a 8 normal stressor. 9 Did Mr. Forsyth feel trapped in his marriage? 10 Well, not abnormally. And this was the one that got 11 me. Dr. Healy said that Mr. Forsyth had no abnormal 12 or pathological stress acting on him in these last 13 months of his life. The evidence just doesn't support 14 that. 15 Was his depression out of control? Dr. Healy 16 says no, but clearly the answer is yes, if you just 17 read Dr. Roberts' record. 18 Suicidal thinking, you may remember Dr. Healy 19 didn't really want to give an answer to that one. And 20 you give whatever weight you think it deserves. 21 Now, here's the one, the important one for 22 Dr. Healy's opinion in addition to akathisia because I 23 think we've seen, by anybody's definition, by his or 24 by the rest of the world's, Mr. Forsyth didn't have 25 akathisia during the time he was taking Prozac, no 2739 1 subjective feeling of restlessness. There is no 2 evidence of that, and certainly no objective movement. 3 But here, Dr. Healy's opinion about the causation of 4 what happened here is based upon his view that 5 Mr. Forsyth had only a mild to moderate depression. 6 And that's pretty important to Dr. Healy's opinion. 7 Look exactly at what he says about that. 8 I was asking him about what do you do to try to 9 account for what happened in a case like this? He 10 said, well, we're looking at alternative causes and he 11 says, obviously, in this case, you would want to look 12 at his being depressed. Did his being depressed cause 13 him to do this? See, right here. In the possible 14 causes according to Dr. Healy, depression, that was 15 one of the big causes he considered, and here's what 16 he said: "I looked very, very closely at this," says 17 Dr. Healy. "I looked through the record and for my 18 money, Mr. Forsyth was only mildly depressed. And 19 I've shown you the risk of suicide with this 20 particular condition should be almost zero." 21 That is what Dr. Healy's opinion is based upon. 22 That Mr. Forsyth had just a mild depression and that 23 the risk of suicide with that kind of condition is 24 just about zero. We're going to see in a second, and 25 you'll remember everybody else, Dr. Roberts, did he 2740 1 have a severe depression? Absolutely. That's the guy 2 that treated him, severe depression. And even 3 Dr. Maris talking about the risk of suicide places 4 Mr. Forsyth pretty high up on the ladder of risk of 5 suicide. 6 So in evaluating Dr. Healy's opinion, take two 7 things in account; it depends on akathisia and 8 akathisia isn't there, and it depends on a mild to 9 moderate depression. Here's the testimony. Mildly 10 depressed. And the record doesn't show that. The 11 record shows Mr. Forsyth had a severe, severe 12 depression. So I think his opinion falls based upon 13 the kind of depression he had and whether he had 14 akathisia. 15 Look at the marital one, you know, we're going 16 to see in just one second, but Dr. Healy thought that 17 the Forsyths had a relatively normal marriage, 18 ordinary domestic kind. Yes, they reconciled. God 19 bless them. They tried to get back together, but if 20 you follow Dr. Roberts' records through, that 21 marriage, there were serious problems there, and the 22 problems changed from one of conflict to one of 23 Mr. Forsyth was so anxious and so fearful, he was 24 bonded to his wife and could not get away from her, 25 which created a whole different kind of stress. So I 2741 1 think when you look, Dr. Healy's opinion on cause just 2 doesn't hang together. 3 Now, let's look real quickly at Dr. Shlensky. 4 First of all, we've seen his akathisia definition, and 5 by Dr. Shlensky's own definition and his opinion 6 depends on akathisia, it falls because Mr. Forsyth, by 7 Shlensky's definition, did not have akathisia, so his 8 opinion falls. 9 We ran down some things with Dr. Shlensky, was 10 inactivity significant and he wasn't sure about that. 11 And he was. Was Mr. Forsyth fearful he would recover? 12 He didn't agree with that. I think he was. Did he 13 become dependent on his wife? Maybe. I think he was 14 extremely dependent upon his wife. 15 Now, this is a good one. Hopeless before he 16 took Prozac? Dr. Shlensky says no, but he clearly was 17 hopeless by the records of the physicians. 18 Did he feel trapped in his marriage? He 19 clearly did. He said he was. He wrote it himself. 20 He told his doctor. Dr. Shlensky says no. No, he 21 didn't feel trapped. 22 Dr. Shlensky did acknowledge that the religious 23 issue was a stress to Bill Forsyth, and let me just 24 say this, I am in no way putting any kind of criticism 25 or any kind of value on the religious beliefs or 2742 1 activities of these nice people. The issue in the 2 case, though, is Bill Forsyth's psychiatric condition 3 and it is clear beyond argument that the family's 4 attitude and the family's religious beliefs did bother 5 him during his marriage and it affected their 6 marriage. That's the only issue that is important to 7 this case. 8 Now, here, this is interesting. Dr. Shlensky's 9 opinion, remember, depends on akathisia, and he says, 10 did he have -- he did have hand-wringing, pacing, foot 11 tapping, and pacing. Shlensky says yes, he did. 12 Well, not in that record. There's no witness that 13 says that. And this is critical, and it's what 14 everybody needs to understand about depression, when 15 people have this disease, they do things outside of 16 their normal character. You heard it from Dr. Maris 17 and we'll see that again briefly, people do things and 18 their spouses and friends and family are surprised. 19 My God, how could that have happened? How could he 20 have done that? I never would have thought that. 21 That's so out of character. That's what happens with 22 this disease and Dr. Shlensky's acknowledges that. 23 This is also, I think, a very important point. 24 It is a recognized concept that people with -- that 25 have this disease, major depression, they can seem 2743 1 better and start getting a little better, but that may 2 be the most dangerous time for suicide. And you might 3 think about that as it applies to Mr. Forsyth. He was 4 looking a little bit better in Castle. 5 Of course, we've already talked about the fact 6 that Dr. Shlensky acknowledges that part of this whole 7 syndrome is sometimes people who kill themselves, 8 they'll kill somebody else at the same time. And for 9 Dr. Maris' suicide analysis, this is Dr. Shlensky's 10 testimony about the risk period, high-risk period for 11 suicide. Mr. Forsyth had major depression, he was 12 hospitalized in an inpatient program, and I said, "Do 13 you think he was prematurely released?" 14 "Yes." 15 I asked Dr. Maris, "Do you think he was 16 prematurely released?" 17 "Yes." 18 I'm not criticizing anybody at Castle. I'm not 19 criticizing Dr. Neal in any way. I'm just looking for 20 the truth. And if Mr. Forsyth was let go from the 21 hospital prematurely, what did Dr. Shlensky tell us? 22 This period right here, right after the release, very 23 high risk for suicide. And that's what happened here. 24 I want to invite you to do one more thing, and 25 I don't want to read them because I know this is all 2744 1 taking more time than you want to listen to, but one 2 of the things Dr. Healy said, the way I know that 3 Mr. Forsyth had akathisia in Castle Medical Center was 4 the fact that he withdrew and did not participate in 5 any of the group activities. You may remember that 6 testimony. 7 If you look at the Castle Medical Center 8 records, they are Exhibit 164, and turn to the nursing 9 notes, and that's at Page 24, Page 25, Page 26, 10 Page 27, you will see the entries over and over and 11 over again, patient attended scheduled groups; patient 12 participated in community meeting, good participation; 13 participation afternoon groups, good participation; 14 interacted well with peers; attended all scheduled 15 groups. All the entries are the same. I don't know 16 if Dr. Healy wasn't familiar with this, but his 17 relying upon somehow that Mr. Forsyth did not 18 participate in the groups, well, is just wrong. It's 19 not correct, and you can look at that record and see 20 that. 21 Now, I want to point out just a couple of 22 things about the medical records just to remind you. 23 The reason I'm doing it is, as the witnesses were 24 presented to you, they were presented all out of order 25 and it's kind of hard to follow. Where was the 2745 1 marriage? We didn't see the doctors in chronological 2 order, and I just want to point out a couple of 3 things. 4 First, from Dr. Brady, just two points: 5 Dr. Brady is the marital counselor, the first, sort 6 of, mental health professional that Mr. Forsyth saw 7 that we heard about. This is when he separated from 8 his wife. He's in L.A. He first sees Dr. Brady on 9 his own and then they're seen together. One of the 10 key points here is this entry right here, "Conflict is 11 not acceptable because it is catastrophic." That's in 12 Bill's list. 13 Bill Forsyth was a person who could not deal 14 with stress and conflict. He simply was a person that 15 just couldn't handle it, couldn't process it. And 16 what was his means of dealing with it? His means of 17 dealing with it was running away. And it's not to be 18 critical of him. It was just a description of how he 19 handled it. You'll remember the evidence that when it 20 came to every interaction, every conversation with his 21 wife was overwhelming to him. He would leave the 22 room, he would leave the house, and he would leave the 23 island. That was the way he would handle it. He 24 would simply get away. He couldn't deal with it. 25 Now, there's been a lot of testimony from 2746 1 friends and so on about comments the Forsyths made 2 about how their marriage was doing after they finished 3 counseling with Dr. Brady, and what's important is to 4 see these things in chronological order. 5 They finished up with Dr. Brady on December 4th 6 and returned to Maui on December the 7th, and here we 7 have the first visit to Dr. Roberts on December the 8 16th, and what do we see? The marriage was supposedly 9 back together. They were going to do great and move 10 on. What does he say after he returns with his wife? 11 Loneliness is his biggest problem. And we will see 12 that his conflict and stress in their relationship, in 13 fact, did change, but it didn't get better. It got 14 different. He became co-dependent on his wife, a new 15 feeling. His fear and anxiety forced him into this 16 dependency. And again, co-dependent on his wife. And 17 he described it, now they're on top of one another and 18 he can't take the stress. 19 His depression out of control, anger on his 20 side of things, anger at his wife. And as he goes on 21 treating with Dr. Roberts, he now gets a trapped 22 feeling. So, you see, the marital relationship has 23 changed some, but it hasn't gotten better. It's 24 gotten different, and he now has a trapped feeling. 25 He can't face all the problems. More than he can 2747 1 solve. Again, it is overwhelming him. He can't deal 2 with it. His solution? Run away. That was always 3 his solution was to run away. 4 And again, now attached to his wife, bonded and 5 fearful. Barely keeping up. His history was that he 6 runs away. He lost control of everything. And in 7 essence, as we'll see with Dr. Maris, Mr. Forsyth had 8 lost the ability to run away because of his 9 depression. Because he had -- he was afraid to be by 10 himself. He was afraid to leave the home. He was 11 afraid not to have his wife right there with him. So 12 his method of dealing with stress, was gone. He could 13 no longer do what he had always done. 14 Just give me one second. Again, these are the 15 notes that Dr. Healy thought were just sort of a 16 normal sort of jottings. I just want to go over a 17 couple things in them. Again, remember after their 18 marital counseling was finished on December 4th, the 19 marriage was supposedly back together, better than 20 ever and so on, well, we know what Mr. Forsyth wrote 21 down and what did he talk about? This is December 4, 22 of '92. Determine bitter attitude. June was upset 23 and Bill was in pain. Again, he was out of control 24 and anxious. 25 He talks about his personality change and 2748 1 particularly, he cannot handle stress. He's fearful 2 of being on his own. He's co-dependent. Again, we 3 have the same notes that he himself is making. He 4 can't take stress. He's talking about denial and 5 anger, being out of control. Again, you see it over 6 and over again in his notes, he cannot take stress. 7 Loss of control. He's afraid to be alone. Over and 8 over again, not in control. I'm not in control. I'm 9 not in control. I can't control things. This is a 10 person to whom control was very important. 11 Now, we haven't talked about this one. This 12 is -- you heard during the deposition of Dr. Hawley, 13 which is the doctor in Los Angeles that Mr. Forsyth 14 called, and it is important to talk about Dr. Hawley 15 to get the dates down because on February 22, 1993, 16 Mr. Forsyth called Dr. Hawley and said he was 17 depressed and he was worried about taking Xanax and he 18 feels he needs to be in a hospital. 19 Now, we know from Dr. Roberts' notes and the 20 calendar of the Forsyth family that this call probably 21 took place in the morning, and what's Mr. Forsyth 22 saying before he ever took any Prozac? Gee, I think I 23 need to be in the hospital. This is before he took 24 any Prozac, and then he goes on to see Dr. Roberts in 25 the afternoon and here he calls Dr. Hawley again, this 2749 1 is the first time he gets the Prozac, and he says, 2 I've got a new prescription, so there's your morning 3 call. There's your afternoon call. And of course, 4 I -- the issue is Mr. Forsyth was thinking to himself, 5 gee, I need to be in the hospital before he even took 6 any Prozac. 7 Now, I want to talk about Dr. Maris. Dr. Maris 8 had prediction or risk factors -- now, this is the 9 plaintiffs' expert. The last gentleman who testified, 10 prediction and risk factors for suicide written down, 11 and we asked which ones did Bill Forsyth have? 12 Impulsivity? Yes. Cognitive rigidity? And you'll 13 remember, that's a person who doesn't see any 14 alternatives. He sees maybe only one way, one way to 15 go; tunnel vision. Did Mr. Forsyth have that? Yes. 16 Anger? Yes. Suicidal thinking? Yes. Work problems? 17 Yes. I'm going to skip those trigger factors for a 18 second and go down to Dr. Maris' analysis of 19 prediction of suicide. 20 And remember I asked Dr. Maris, he didn't 21 actually want to give me this answer, but he finally 22 did. These factors of Dr. Maris predicting suicide 23 are statistically significant with actual suicide, 24 completed suicides, and so we go down the list and 25 pre-existing treatments before he took Prozac. Just 2750 1 read them down. Did Mr. Forsyth have depressive 2 illness? Yes. He had a history of alcoholism, not 3 current, old, but the fact that he had that history, 4 gave that a weak positive as well. 5 He had suicidal thinking before Prozac, so 6 that's a risk factor. The religious conflict in the 7 family, Dr. Shlensky gave that a positive risk factor. 8 There's no prior suicide attempt, but then you 9 wouldn't expect one in an older white male. Lethality 10 of method, moderately lethal. 11 Isolation, living loss of support, now, Dr. 12 Maris said, well, he had some changes there. I think 13 you'll remember the evidence about both Bill, Jr., I 14 didn't see my dad all that much, he didn't stay home. 15 Bobbi Comstock, June's best friend, talked about Mr. 16 Forsyth, about going to bed in the afternoon and 17 pulling the covers up to his nose. I think he 18 probably did have isolation there even though 19 Dr. Maris didn't want to give that one a positive. 20 Did he have hopelessness and cognitive 21 rigidity? Absolutely. And what did that mean? Boxed 22 in. I asked Dr. Maris, well, how about trapped? Is 23 that the same thing? He didn't want to go that way, 24 but I think it probably is not too far. 25 Older white male? Yes. No suicide history in 2751 1 the family, so that was not there. Work problems? 2 Yes. Marital problems? Yes. Stress in life events? 3 Yes. Anger, aggression, and irritability? Yes. No 4 physical illness other than the mental illness, and 5 then repetition and co-morbidity, he gave that a weak 6 positive. 7 So I think Dr. Maris counted out that 8 Mr. Forsyth had 11 out of the 15, and let me just add 9 this, all completely independent of him taking Prozac. 10 Now, the whole question is, and Mr. Vickery 11 will make an argument, I know, well, wait a minute. 12 All these things existed before he took Prozac and he 13 never committed suicide and never became homicidal, so 14 the only difference was Prozac, so it must have been 15 the Prozac. Well, let's look at that. 16 What trigger factors do we really have here? 17 Three that Dr. Maris will admit to, and these put, in 18 Dr. Maris' own chart, the person in the suicide zone. 19 He had a major depressive episode, he had 20 hopelessness, and his hospitalization. You'll 21 remember the testimony of various doctors, discharged 22 from a mental hospital after an inpatient treatment 23 program can be very high risk for suicide. Why? 24 Because when you get out, you're not any better. 25 You're not any better. You've gone that final step 2752 1 and gone into a psychiatric institution, and nobody 2 wants to do it. Mr. Forsyth hated it. And you get 3 out, and what's happened? You're no better. 4 Now, I want to add to these trigger factors. 5 Dr. Maris said Mr. Forsyth was a very successful 6 businessman. He handled stress well until now. What 7 does he say in his own writings? "I can't handle the 8 stress. I can't take it. I can't deal with it." And 9 Dr. Maris admitted that in the end, Mr. Forsyth could 10 not handle the stress. That's what depression does. 11 It impairs your ability to cope with stress. 12 Now, I think Dr. Matthews, you know, probably 13 said it pretty well. We don't know everything. I 14 mean, I can't come in here and tell you exactly what 15 happened here. We know what we know, but here was a 16 man, very tragic, who basically was set up by these 17 life events and got this terrible disease which made 18 him unable to consider alternatives, and what 19 happened? He went in to a mental hospital and he 20 didn't like it at all, and he got out, maybe a little 21 early, and he went home. And what was the discussion 22 the night he came home? Where he was going to go for 23 his next psychiatric hospitalization. That was the 24 family discussion. Maybe to a Christian psychiatric 25 institution in the Mainland. 2753 1 A man who could always handle stress. How did 2 he handle it? He handled it by running away from it, 3 getting away. And what couldn't he do now? He 4 couldn't run away because of his depression. 5 Now, the question which you've also heard about 6 and you've heard the experts talk about the risk of 7 violent behavior, suicide, which was severe 8 depression, and Dr. Shlensky also saying, yes, 9 sometimes suicidal people kill someone else, too. We 10 had Dr. Tardiff come and testify. I have to apologize 11 to you. Dr. Tardiff had to get on the airplane, and 12 we had to get him on and get him out of here, that's 13 why he didn't stay on the stand long enough, but we 14 got out the basics. 15 You'll remember, this is a guy who has done his 16 lifetime of research in this area, violence and 17 homicide/suicide and he told us about what the studies 18 show of this kind of event. Three types. Now, 19 Dr. Shlensky didn't say any of this was wrong, but all 20 Dr. Shlensky wanted to talk about was this type, the 21 younger man who was jealous and there's been a history 22 of prior violence. That's what he wanted to talk 23 about. That's not this one at all. We're here under 24 the depressed older male type. 25 And here's what the studies show, that 2754 1 invariably, where there's a homicide/suicide, the 2 person that does the act is a man, an older man, 3 upper -- middle upper income who has depression, 4 psychiatric illness, whose victim is his wife or lover 5 or long-time relationship. You know, what's going on? 6 There are issues in the relationship. What's the 7 dynamic of the suicide? Control versus dependency. 8 What do we have here? That's exactly what we have 9 here. And the location, where do these things happen? 10 Invariably it happens at home and it's usually in the 11 bedroom, and that's what happened here. 12 And I think critically important, and I know 13 Mr. Vickery will talk about this, this was a peaceful 14 man. This was not a man who abused his wife 15 physically. He didn't hit her. He was not a violent 16 man. All of that is true. But when you look at the 17 studies, the kind of people who were involved in this 18 kind of act, there's very rarely a history of domestic 19 violence. These are depressed, older men who kill 20 themselves and take their spouse as well. 21 Now, you will get your instruction about 22 causation and that is Instruction No. 18 and it is an 23 important instruction, because it is one of the key 24 issues, obviously, in the case. One key issue is was 25 the warning in the insert adequate? Did it raise the 2755 1 issues that the prescribing doctors get adequate 2 information? That's one issue. The second issue, did 3 Prozac actually cause the deaths of Mr. and 4 Mrs. Forsyth? 5 So your causation instruction is 18, and it 6 says that Prozac has to be a substantial factor in 7 bringing about these deaths. It doesn't say a little 8 factor. It doesn't say one among many other factors. 9 It says a substantial factor. And I want to ask you 10 to think about it in this way: Think about all of the 11 evidence you know about, of the Forsyths history, of 12 Mr. Forsyth's illness, of his treatment, of his 13 hospitalization, of his feelings before he ever took 14 Prozac, how his depression was getting worse, wasn't 15 getting any better. Set Prozac to one side. Forget 16 Prozac for right now. Think about every other fact in 17 the case. His relationship with his wife, his 18 relationship with his family, his problems with 19 retirement, his problems with communicating with his 20 wife, the religious controversy, he's hospitalized, he 21 comes home. He's not any better. He's now bonded to 22 his wife, afraid to be by himself. He can't use his 23 usual coping mechanism to get away. He cannot handle 24 stress. 25 If you consider every one of those facts, and 2756 1 you were asked the question, what happened here? I 2 think you'd probably come to maybe to two conclusions, 3 possibly. You might say, well, gee, you know, I don't 4 know. Or you'd say, based upon everything we know, 5 all the expert testimony in this case, this man, 6 because of his personality and life stressors on him 7 and his disease killed his wife and killed himself 8 because of the pressure. 9 Or you might say, gee, I don't know. I'm not 10 too sure. Then you can say, well, because it is part 11 of the major depression based upon the studies we 12 have, what we know about the stressors on him, he 13 couldn't handle stress, he couldn't run away any more, 14 that would be the answer. One of those two things. 15 And either one of them is fine. So that's given. 16 Now, put Prozac back into the equation, and 17 think, what is everything we know about the effect of 18 Prozac on Mr. Forsyth? Is there any evidence that 19 Prozac had any bad effect on Mr. Forsyth? I submit to 20 you that there is not. Every person who observed him 21 during every time he was taking Prozac, he had no 22 adverse reactions. He did not have akathisia. It did 23 not make him agitated. He did not have a subjective 24 sense of restlessness. He was depressed, sure, but he 25 was calm and quiet and subdued. That's what we know 2757 1 about whether Prozac had any effect on him. 2 Now Prozac is back in the equation. Does it 3 make any difference? Is your answer any different? 4 Based upon what we know about whether Prozac had a bad 5 effect on him, I don't think it is. And that's what 6 substantial factor is all about. I think you'll 7 probably come up with the same answer. That this was 8 probably due to his major depression and his life 9 events and the stressors or, you know, I'm just not 10 sure. I just don't know. But there is no evidence, 11 none, that Prozac had any bad effect on Mr. Forsyth. 12 So I think your answer is that it doesn't make -- 13 doesn't make any difference. 14 Now, I want to raise maybe just one more point 15 with you. Maybe I'll just put up one, one more 16 blowup. And this is one of the blowups from Jane 17 Forsyth's notes. It's from the 1991 period. This is 18 not from March of '93, but I'm going to put it up as 19 an example. That's not the one I want to put up. 20 Well, I can't find that one. 21 It's the one that says, "No way out forever." 22 I only use that as an example because that's what 23 Mrs. Forsyth wrote during the time when she was in the 24 depths of her depression. "No way out forever." And 25 I asked Dr. Matthews about that and you may remember I 2758 1 put that up for him. Can you tell us what that means, 2 what depression can do? What it means is it can be so 3 powerful and you simply think there is no way out 4 except to end everything. I just offer that as an 5 example to you of the kind of dynamic that was going 6 on -- probably going on in this case. 7 Now, jury service is, I think, and I've heard 8 this a lot of times, next to defending your country 9 and next to voting and choosing your leaders, it is 10 the most important civic thing that you do, and I 11 believe that's so. 12 Again, this has not been an easy case to listen 13 to. I know that. It hasn't been an easy case to try 14 because it's painful. We've had to look deeply at a 15 very painful episode in the life of this family and 16 what happened to them shouldn't happen to anybody. 17 But we've talked about taking our sympathy and setting 18 it aside and looking at the facts of the case and 19 making a decision based upon an impartial look at the 20 facts of the case, and that's what you're required to 21 do. I am very confident that you will do that, and 22 when you take that impartial look and make your 23 decision based upon the evidence in the case, that you 24 will conclude that there is no evidence in this case 25 that Prozac caused these deaths. Because there's no 2759 1 evidence in the case that Prozac had any bad effect on 2 Mr. Forsyth. You think about it. Where is it? 3 Where's the evidence? 4 The expert opinions of the plaintiffs depend 5 upon the condition akathisia, and however you define 6 it, that condition is not here. There's no evidence. 7 Whether Prozac is defective, as the plaintiffs claim, 8 depends on whether Lilly failed to adequately provide 9 information to bring to the attention of the 10 prescribing doctors that there had been reports of 11 suicide, reports of violent behavior, reports of 12 akathisia, and you seen Lilly did all those things, 13 not only in the insert, but sent out a separate letter 14 to do it as well. 15 The Court has given you the form of verdict or 16 hasn't given it to you yet. I think we'll give it to 17 you when we're finished as part of your instructions, 18 and the clerk has read to you paragraph one which 19 says, "We the jury in the above-entitled case, 20 unanimously find in favor of" and then it has two 21 blanks, and what I want to ask you to do is after you 22 do your duty and evaluate the case based upon the 23 evidence that you've been presented, setting your 24 sympathy, understandable as it is, aside, to enter 25 your verdict in favor of Eli Lilly and Company. I 2760 1 have every confidence that you will evaluate the 2 evidence in a fair and impartial way and come to a 3 just verdict. Thanks very much. 4 THE COURT: It is 2:15. Let's take a 15-minute 5 break. Please be back at 2:30. 6 (Whereupon, a recess was taken at 2:15 p.m.) 7 THE COURT: Please proceed, Mr. Vickery. 8 MR. VICKERY: Thank you, Your Honor. May it 9 please the Court, ladies and gentlemen, I know you're 10 probably tired of listening to us recapitulate the 11 evidence for you. I hope that it will help. I'm 12 tempted to just say, I know you know the answers to 13 all -- everything he just said better than I do, but 14 I'm scared to. Scared to. 15 You know, they say a picture is worth a 16 thousand words. Well, if this is a broken marriage, 17 I'll eat my hat. If this is a man that through life's 18 stresses, explains him killing his wife. I know 19 Mr. See asked Ms. Comstock when she saw the ambulance, 20 you thought he killed himself, didn't you? She said, 21 yeah, I did, but that's a hundred and one chance. It 22 was a long shot, but she still thought. But if, 23 whether we use our common sense, or whether we use 24 statistically significant scientific information from 25 Dr. Maris, the odds of depression and life stressors 2761 1 explained what happened on March 3rd on Maui are 2,000 2 to 1. 3 Now, Mr. See's said a bunch of things that I'm 4 going to briefly address. First, let's use our common 5 sense together. I agree with him about the SSRIs. 6 They're real hard to overdose on those, real hard to 7 kill yourself by an overdose. That's the major 8 marketing advantage of those drugs. 9 So what do they say in their package insert 10 about suicide? The only thing, the final sentence, 11 "Prescriptions for Prozac should be written for the 12 smallest quantity of capsules consistent with good 13 patient management in order to reduce the risk of 14 overdose." Why? There is no risk of overdose. 15 What do the people in the corporate 16 headquarters of drug epidemiology say? Claude Bouchy 17 after a month, this isn't a lack of Mr. Bouchy didn't 18 understand so, boy, they set him straight the next 19 day. He said we've argued this back and forth for a 20 month. The people in the drug epidemiology unit in 21 the corporate group said change suicide attempt to 22 overdose. 23 Now, I don't know, in Texas we call it plain 24 ole horse sense. If the drug doesn't -- if you can't 25 kill yourself by overdose, then why would they put 2762 1 that in that pigeon hole? What if we took all of your 2 exhibits and we put them in pigeon holes and we took 3 all of the ones that were related to suicide or 4 suicide attempts and we put them in a folder and we 5 marked in overdose on the outside and we said, ladies 6 and gentlemen, for your convenience we have placed the 7 exhibits in relevant pigeon holes. 8 As soon as you got back to the jury room, you 9 would say Mr. See says that this drug doesn't cause 10 death by overdose. Mr. Vickery agrees. We're not 11 going to look at those documents. We're not going to 12 look in that pigeon hole. We're wasting our time. 13 That's what common sense is all about. 14 Now, I don't think Dr. David Healy needs me to 15 defend him, but I do want to talk about the two things 16 that Mr. See talked about, akathisia and the 17 depression or the degree of the depression. We'll 18 start with akathisia. 19 Back in 1989 the internal Lilly document, 91, 20 talks about the article from Dr. Lipinski and it says, 21 "There are a triad, three, of symptoms that reflect 22 the syndrome of akathisia; anxiety, nervousness, and 23 insomnia." When you get the Castle Medical records 24 and I'm glad that Mr. See has encouraged you to look 25 at them. They're not real easy to read, but you can 2763 1 do it. Here's what they say. Those three symptoms; 2 anxiety, nervousness, insomnia. Quote, the patient 3 claims he's had some difficulty with insomnia, has 4 been moderately anxious. That's that one. And that's 5 that one. "Patient reports recent increase of 6 anxiety. Patient reports nervousness." Oops, there's 7 that one. 8 2/24 from Rick Poole, "Increased anxiety 9 today." 2/26 staff notes, "A lot of anxiety lately 10 and been thinking about suicide." Staff notes, 3/1, 11 "Very anxious." Poole notes, March 1st, "Poor sleep 12 pattern." Where is it? It's right in there in the 13 records. And there was no DSM-IV. Nobody's talking 14 about motor movement, but since Mr. See did mention 15 the Lane article, let's do look again at what Dr. Lane 16 said. 17 It's less than a year ago. The SSRI-induced 18 akathisia is relatively rare, but frequently 19 unrecognized. The precise definition is a matter of 20 controversy as is the importance of objective, 21 subjective aspects of the disorder. Is akathisia a 22 movement disorder or an intense and uncomfortable 23 mental state? It may be less of a question of 24 patient's experiencing Prozac-induced suicidal 25 ideation and patients feeling death is a welcomed 2764 1 result when the acute discomforting symptoms of 2 akathisia are experienced on top of already 3 distressing disorders. 4 Now, this is what Dr. Reus admits is accurate 5 if someone has already a distressing disorder and they 6 get akathisia from Prozac on top of it, that they 7 could, indeed, have acts of death or violence. It is 8 right here. 9 I, too, have some transcripts from this trial. 10 From Dr. Reus' testimony, "Do they cause akathisia? 11 They can cause akathisia?" 12 "Yes." 13 "All three of them, Paxil, Zoloft, and Prozac?" 14 "Yes, they can." 15 And I said, "Well, do they cause?" 16 "Well, they can cause it. Not that they do. 17 You have to evaluate each individual case." 18 And I said, "All right. Now, wait a minute. 19 Is this one of these deals where you have to have a 20 clinical trial?" 21 He said, "I don't know how I could be more 22 clear than I just have been. I said the SSRI drugs 23 can cause akathisia. Not necessarily do, can cause." 24 "Okay, sir." 25 "It's a relatively rare side effect." 2765 1 Side effects are something that is caused by 2 the drugs, and so then I asked him about the 3 relationship between suicide and violence and he said, 4 "I believe what akathisia does is creates a state of 5 severe anxiety which can exacerbate pre-existing 6 proclivities and cause people to engage in suicide or 7 violence." 8 And I said, "Well, that's a mouthful of words. 9 Are you saying it can contribute to suicide and 10 violence?" 11 And he says, "It's the state of extreme anxiety 12 and if someone is predisposed to suicide, it can 13 increase the risk of suicide and also for anxiety in 14 the case of someone who is contemplating violent 15 action or who is prone to violent action can lower the 16 threshold for engaging it." 17 That's one of the top experts that Eli Lilly 18 brought to testify for you. And you know, there's 19 other evidence of akathisia, the constricted effect 20 that Dr. Neal noticed, Kim's testimony, you know -- I 21 guess, Mr. See says discount Kim Forsyth's testimony 22 because I only asked her one question and she didn't 23 say anything about his hands. Well, you saw her, and 24 you can judge for yourself. You think she's just 25 lying to try to help out, just making stuff up? Or 2766 1 did you get the impression that she was a woman that 2 was remembering something that she had seen very 3 vividly? 4 I suggest to you that there's no question about 5 akathisia. I don't usually do this, but I had to make 6 a bunch of notes here, so you all bear with me. 7 Dr. Van Putten, one of the leading 8 authorities -- the leading authority, according to 9 Dr. Healy, said akathisia has many faces. It's hard 10 to put down, and Dr. Healy said, well, it's clear-cut 11 from the patient's perspective, and I've tried to 12 think of an analogy, something in my own experience 13 and perhaps yours that might help us, because if you 14 know what to look for, then you know what you're 15 experiencing or what others are experiencing. 16 There are folks, and I'm one of them, that tend 17 to get sea sick if they go out too far on heavy seas, 18 and if you know that the motion of a heavy sea and the 19 rocking of a boat can make you ill, then when you 20 begin to feel that queazy feeling, you know what it is 21 that's happening to you, and if those that are with 22 you -- even before you complain, even before you're 23 hanging over the side of the boat, if those that are 24 with you kind of see that you're a little green around 25 the gills, they know. And they say, are you feeling 2767 1 all right? Is this making you sick? And they know 2 what to do to counteract it as do you. 3 You see, foreknowledge is being forearmed. If 4 you know what can happen to you, then when it happens, 5 instead of you spinning out of control, if you will, 6 with anxiety, you say, okay. I know what this is. 7 This is the effect that's caused by the sea or this is 8 the effect that's caused by this drug that the doctor 9 told me about, and so I'm supposed to call 10 1-800-SUICIDE where somebody is going to help or I'm 11 supposed to call my doctor or I'm supposed to take 12 that Inderal pill. 13 Remember Dr. Neal's testimony, he had one on 14 March the 3rd because he left the hospital. And let's 15 look at it. I asked him, I said, well, did you -- I 16 didn't have it blown up. 17 We see here that he's on Inderal and he gets 18 four doses every day, the 26th, 27th, 28th. Can you 19 help me on that? March 1st he gets it four times. 20 March 2nd he gets it four times, but the next day, the 21 very next day, the day he killed his wife and he 22 killed himself, he only got one dose. 23 Now, this is the medicine, you will remember, 24 that Dr. Neal said he gave him because he had heard 25 that Prozac might cause akathisia. And he answers, 2768 1 "Well, that's because he left." 2 MR. SEE: I object. That just misstates the 3 testimony of Dr. Neal. 4 THE COURT: Sustained. 5 MR. VICKERY: With all due respect, Your Honor, 6 that's my recollection of it. 7 THE COURT: Well, I'll leave it to the jury's 8 recollection. 9 MR. VICKERY: Thank you. He answered, "Well, 10 that's because he left. He left in the morning. He 11 only got one dose before leaving." 12 And I said, "Well, certainly, you didn't tell 13 him that he needed to take this to ward off akathisia 14 or suicidality, did you, sir?" 15 And he said, "I didn't tell him he had to take 16 it for that, no." 17 And I said, "And the reason you didn't tell him 18 is because Eli Lilly and Company never told you that, 19 did they? They never told you that it would cause 20 this and they never told you that you needed to take 21 these measures; isn't that true, Dr. Neal?" 22 And he said, "They didn't tell me that, no." 23 And I said, "Mr. See asked you when he got up 24 here about whether you would put any stock in the 25 information that I tried to provide to you and sending 2769 1 you stuff from Dr. Healy. That's a far cry different 2 thing to get information from a lawyer and information 3 from a witness that lawyers hired than it is to get 4 information from a company itself; isn't it, sir?" 5 And he said, "Well, I don't understand what you 6 mean." 7 I said, "What I mean to say is if Lilly told 8 you this, that there's a problem, Doctor, and you need 9 to do something about it, you would have been much 10 more careful, wouldn't you?" 11 "ANSWER: I guess." 12 "Wouldn't you take heed of whatever warning Eli 13 Lilly gave you about this medicine?" 14 "ANSWER: I would take heed of any warning they 15 gave me, yes." 16 "If they gave you a big bold warning, whatever 17 it might say, you would look at it and you would heed 18 it, wouldn't you?" 19 "Yes, I would." 20 He said it and the law presumes it, and the law 21 presumes on the issue of causation that a failure to 22 warn leads to causation unless it's proven to you 23 otherwise. That's the effect of a presumption. So, 24 is there akathisia? Yes, there is. And the opinions 25 are soundly based. 2770 1 Now, how about this depression issue? Did he 2 have moderate or severe depression? Well, here's what 3 we know. Three mental health professionals, all with 4 doctorates, a Ph.D. or an M.D., none of the three of 5 them think he's suicidal; not Tom Brady, not Riggs 6 Roberts, not Randolph Neal. None of them think that 7 he needs to be in the hospital really. You know, the 8 very first reaction that Dr. Riggs Roberts has -- I 9 mean, Mr. See just told you, Dr. Roberts thinks he was 10 in a severe depression. Well, he didn't think he 11 needed to be in the hospital. Even when the man's son 12 first called. That was his first reaction. 13 So they didn't see suicidality and they didn't 14 think that he needed to be in the hospital. Well, 15 what have the people that knew this man told you? I 16 can't believe Mr. See is talking about this pulling 17 the covers up. Ms. Comstock said that there was one 18 day, one day out of months where her friend June told 19 her that Bill's in there and he's got the covers 20 pulled up over him, and from that we're to assume he 21 was in a deep, dark depression for months and months. 22 What did his son say? My dad didn't have his 23 usual spunk. They tried to get him to say he had this 24 major personality change, but he didn't. He said, he 25 just didn't have his usual spunk, but boy it was 2771 1 different on February the 24th. It was real 2 different. That was the first time that I ever was 3 worried about my father. All those months before he 4 wasn't, but that day he was worried sick. 5 What does Susan say when she talked to her 6 father on the telephone from Castle Medical Center, 7 17-minute conversation she's upset about him. He 8 wants to go have dinner at the psychiatric ward 9 instead of talking to his daughter who's worried sick 10 about him. Now that was after Prozac. But before, 11 she had never worried about him before. It was 12 never -- I mean, he was the same dad before. 13 What did Kim Forsyth say? She said well, you 14 know, there was a dramatic change on February 24th. 15 It was something I had never seen in him. He looked 16 like I had never seen. 17 Tom Brady, I called him a couple of times and 18 he seemed to be doing fine. Two weeks before they go 19 in the hospital, Bobbi Comstock said I saw him at a 20 party, a shower given for Kim Forsyth. So deep, dark 21 depression? What did Ms. Smith say, Dorothy Smith? 22 In the first week in December he's chasing the 23 grandkids around. He's just taken out an office in 24 Kaanapali. He's planning a trip to the Greek Islands. 25 He's looking forward to the birth of his grandkid. 2772 1 Well, he was having some bad days, no question 2 about it. I'm not trying to belittle it, but deep, 3 dark depression? There's a deep, dark depression -- I 4 mean, they make it sound like he had one foot in the 5 grave. This man did not have serious problems until 6 February 24th, two days after taking Prozac. He 7 didn't have serious health problems until then. 8 Now, what about all these records from Riggs 9 Roberts? Well, here's my take on that and you may 10 have your own, but... We know that the very first 11 record is a history, that he's taken a history. And 12 we know that through the process each week of visiting 13 with someone, he's trying to dredge up old things. 14 Unfortunately, we can't tell from Dr. Roberts' notes, 15 whether the things he's written down are things 16 currently being experienced or they're old things that 17 are being dredged up. 18 Now, does he need help? Sure, he needs help. 19 He's going to a psychiatrist. I'm not saying he 20 doesn't need help. I'm just saying that let's not put 21 too much stock in all of the old stuff that he brings 22 up at that point in time. Point of order, religion. 23 You know, we never brought up the subject of religion, 24 why? Because this man had a profound personal 25 experience in January. There's not a shred of 2773 1 evidence otherwise. 2 Dr. Roberts' note say on January 18th he was 3 fighting God back, and on June's calendar on January 4 24th it was his spiritual birthday. And there's not a 5 shred of evidence that there was any active religious 6 disagreement after that, and yet they bring it up time 7 and again. And never once say, but you know, he did 8 have a profound experience. That wasn't in the 9 equation in February and March, ladies and gentlemen. 10 I want to be fair with you. They never say that. 11 They never say -- because, you know, Ms. Comstock told 12 us that those books that bothered him for his wife to 13 have around, he was reading them by the end of 14 January. 15 So, was he depressed? Of course, he was 16 depressed. But let's use our common sense taking 17 together what everything said about him. How sick was 18 the man? If he had needed to be hospitalized, Riggs 19 Roberts would have put him in the hospital. If he had 20 shown suicidality, he probably would have put him in 21 the hospital. Even Dr. Neal didn't think he needed to 22 be in a hospital. He was ambivalent about it as was 23 the patient and let him go. 24 Looking at my notes, I see there's one more I 25 forgot and I don't know how I could, Dave Capelouto, 2774 1 he was the man's friend for 50 years, knew him since 2 the tenth grade and he saw him in early December, and 3 said his marital relationship was better than ever. 4 His marital relationship was better than ever. So 5 religion, marriage, was he depressed? Sure. Was he 6 having marital problems or religious problems in 7 February of 1993? No. No, he was not. 8 Part of the problem I guess I have in 9 reconstructing what happened with Dr. Roberts is not 10 only the fact that they dredge up old stuff and the 11 notes aren't clear, but when I asked him about it, he 12 said, I've got brain mush and I can't really put all 13 that real clear in context for you. So, you know, the 14 best that we've got is we know that he needed help. 15 We know that he needed help and we know that he was at 16 risk for himself, but not his wife, and the help he 17 got, unfortunately, was ill-informed help. 18 Now, I want to talk to you about Mr. See's 19 comment that Lilly responded in such a rationale and 20 reasonable way in studying this. They went back to 21 the meta-analysis -- well, we've already talked about 22 the fact that they were looking at a population of 23 patients that didn't include the dropouts. 24 5.3 percent dropped out because of this triad of 25 symptoms we just talked about. And so, when they went 2775 1 to study this in this responsible way, they were 2 looking at a population of patients that didn't 3 include them. What else didn't it include? Let's 4 look at Dr. Beasley's testimony. We have that over 5 here, don't we? 6 You have information through December 14, 1990 7 that 198 suicide deaths in the United States that 8 happened, and then there were 94 outside of the United 9 States. 10 "QUESTION: So you actually had almost 300 11 deaths reported by suicide of individuals taking 12 Prozac ten months earlier than this article was 13 written, didn't you?" This was a famed meta-analysis. 14 "Yes." 15 "And that's not anywhere reflected in your 16 paper, is it?" 17 "No." Well, he won't say no. "Not in that 18 paper." 19 "Well, what paper is it in?" I don't have any 20 other paper except the meta-analysis. They didn't do 21 the rechallenge. That's the best science available. 22 If you want to talk about what was knowable from the 23 best science available, it would have been if Eli 24 Lilly had done the meta-analysis -- I'm sorry, the 25 rechallenge study that Dr. Beasley drafted up. That 2776 1 would be the best science available. They didn't want 2 to know the answer or actually, I think they knew the 3 answer, but they didn't want to hear it. And they 4 certainly didn't warn about it. 5 If you want to use the baseball analogy, ladies 6 and gentlemen, and I have to confess I'm a bit 7 offended by it, but if you want to, Dr. Beasley's 8 analysis is like looking at the people who finished in 9 the ninth inning, but it doesn't include those that 10 were hit by fastballs and taken out of the game in the 11 early innings because it didn't include the dropouts. 12 Another very important instruction you have, if 13 you still have the instructions in your laps, if 14 you'll just look at number five at the last paragraph. 15 It said that the lawyers questions aren't evidence. 16 What's evidence is the answers. And that becomes real 17 important when you get to all of those things that 18 Mr. See just read you about Mackay and Leon and 19 Warshaw. Those were things in questions that he asked 20 Dr. Healy, but it's Dr. Healy's testimony that's the 21 evidence. And what his testimony is that two of those 22 involved 654 and 643 patients, I think. Not enough to 23 be an epidemiological study or tell us anything of 24 significance. One, the Mackay study involved -- was 25 prompted by Eli Lilly and supported by Eli Lilly, but 2777 1 was inconsistent. 2 MR. SEE: I beg your pardon, but that's not the 3 evidence. Not the Mackay study. 4 MR. VICKERY: Okay. Which one was it that was 5 sponsored by Lilly? It was one of them. Ditman. 6 Ditman. Not Mackay. I stand corrected. But he 7 considered all of those. With 11,500 published 8 articles, you would think somewhere there would be an 9 article where Eli Lilly has studied the issue of does 10 Prozac cause suicide or violence. Something. And all 11 there is is Charles Beasley's meta-analysis as flawed 12 as it is for the various reasons that we've discussed. 13 They've just never done it. And only they have the 14 resources to do it. 15 There are a number of other articles, though, 16 and I can go over them in Dr. Tollefson's testimony. 17 I won't. I'm sure you remember them and have good 18 notes. All of the various articles from 19 well-respected people at Harvard and Yale, and 20 elsewhere. You know, it's not that it's from Harvard. 21 He says I criticized the Harvard medical or mental 22 health newsletter. I guess, Mr. Vickery doesn't like 23 Harvard or something. It's not that. It's not that 24 at all. It's unsigned. It's not peer-reviewed. It's 25 nothing that we can put any credence in. I can't 2778 1 cross-examine articles. I can't cross-examine 2 Dr. Stuart Montgomery's article, this man who 3 Dr. Healy testified is a consultant for Eli Lilly. I 4 can't do that. That's why the Court tells you that 5 it's the answers that are the evidence. 6 If Dr. Stuart Montgomery was here, believe me, 7 I would have some questions for him. If Dr. Charles 8 Beasley were here, I would have some questions for 9 him, and he works for Lilly. Stuart Montgomery is 10 just a consultant. Beasley works for him. This is 11 the man Charles Beasley wants to persuade you is so 12 reasonable, where is he? 13 Ladies and gentlemen, I want to end by talking 14 to you about warnings and how important they are. 15 We're not asking you to take this drug off the market. 16 I don't know why they show that except to say, see, 17 the FDA is impressed by what we're doing. What we're 18 saying is people need to be told. The doctors who are 19 prescribing need to be told the full truth. They need 20 to be told everything that you folks knew beforehand. 21 Everything that you knew as I've gone through somewhat 22 painstakingly with you because the documents are 23 there, you will see what this company knew and they 24 just weren't told about it. It's just not a box 25 warning. That's not the only way they have to 2779 1 communicate. 2 You'll remember their admission in the request 3 for admissions that they admit that it relies on 4 package insert, these tiny little print things, 5 medical and scientific literature, direct mail, and 6 direct communications consistent with package inserts 7 by sales of its representative to apprise prescribing 8 physicians of risks, indications, contraindications, 9 and other pertinent information. Those are the people 10 that they rely on, but they told the salespeople in 11 '90 and '91, don't bring it up. And then by '92, we 12 know when Amy Lee is going through a whole month of 13 training in Indianapolis, they don't tell her anything 14 about it in a whole month, so these see no evil, hear 15 no evil, speak no evil, the others were told not to 16 bring it up. 17 The only letter they sent out, the dear-doctor 18 letter he -- please read it. You'll see if that's a 19 warning that this drug can cause akathisia and can 20 cause violence and suicide in some people or is it, on 21 the other hand, an assurance designed to placate 22 doctors and get them to keep prescribing these pills? 23 That's exactly what it is. 24 The warning that he points to isn't a warning 25 at all. It's a precaution. It's on high-risk 2780 1 patients. How would that alert Randolph Neal or Riggs 2 Roberts, neither of whom thought this was a high-risk 3 patient? Those are the people we need to worry about. 4 This isn't one of them. He's not in that category. 5 So in the final analysis, this is your case. 6 Ladies and gentlemen, I've done all that I can to 7 bring to you the truth, realizing that you're the ones 8 that have to ferret out the truth. And I just have 9 two thoughts to leave you with. One I want to respond 10 to Dr. Matthews about psychosis because I have that 11 transcript too and he wants you to go back and look at 12 what Kim Forsyth said in her deposition and give that 13 more credence than what she said in court. 14 I asked Dr. Matthews, are you going to stick 15 with Page 24 on your report, that report where you 16 talk about it being unrealistically concerned about 17 the cost of care and financial worries and these are 18 common of psychosis, are you sticking by your report 19 there? I didn't mean it that he didn't have 20 psychosis. He said, "I'm not changing my mind at all. 21 I want to make that clear. I think that he may have 22 been psychotic." In the report, "Psychotic features 23 may have been present and I cite it in the report, but 24 I think on balance, if you have to choose one way or 25 the other, was he or was he not, the better evidence 2781 1 is that he was not." So in his report he said yes. 2 In court he said could have been, but on balance, I 3 choose not psychotic. 4 Folks, Bill and June Forsyth did not have to 5 die. This is a case about drug-induced violence, but 6 it is also a case about priorities. Eli Lilly made 7 their priorities very clear in February, and again, in 8 November of 1990. And the priority, number one, was 9 to protect Prozac. 10 Priority number one for my clients is to 11 protect people, to try to make some sense out of the 12 senseless tragedy that has occurred in their family, 13 some sense, and the only way they can which is to 14 bring this case here for you to decide. 15 I'm sorry that Mr. See chose not to give you 16 the benefit of his years of experience and his wisdom 17 to help you out on assessing damages in this case. 18 I'm sorry he did that, but we trust you, as neighbors 19 of these people, as the conscience of this community 20 to make an award in this case that is fair considering 21 the laws that are pertinent to the tragic and 22 unnecessary losses that have been suffered by this 23 family. You see, when your priority is helping out 24 people, you fly to Indianapolis. When people try to 25 help out other people, you establish a non-profit 2782 1 organization and put information on the Internet, and 2 man 1-800 lines. When your priority is helping 3 people, you even go so far as to sit in this 4 courtroom, as these fine people have for all of these 5 weeks now, while the worst dirty laundry of your 6 parents is dragged out in public, while it's made to 7 appear that your mother had depression in '91 and that 8 somehow that effects her in '93. While your father is 9 called a philanderer, and your mother is branded as a 10 religious fanatic. If your priority is helping your 11 public, that's what you do and that is what they have 12 done. 13 Justice is like an island rugged without a 14 beach. Once you've left it, it is beyond your reach. 15 Ladies and gentlemen, it is within your grasp, don't 16 let it slip away. What you do today will be justice 17 for this family, and indeed, for all of America. 18 Thank you. 19 THE COURT: The Court will now swear the 20 bailiff. Raise your right hand. 21 (Whereupon, the Court swore in the bailiff.) 22 THE COURT: The Court will instruct the bailiff 23 to take the jury to the jury room and commence their 24 deliberations, but before you do, I want to caution 25 the jury, as I did at the beginning of the trial, not 2783 1 to watch anything on the TV or read anything in the 2 newspapers or listen to anything on the radio that 3 might involve this case. That's very, very important. 4 The Court will dismiss the jury. The jury will 5 begin their deliberations. 6 (Whereupon, the jury left the courtroom, and 7 the following proceedings were had in open 8 court out of the presence of the jury.) 9 THE COURT: I want counsel to get together with 10 the courtroom deputy when she returns to be sure that 11 the proper exhibits go to the jury. And I want you to 12 remain in close touch in case the jury has any 13 questions or reaches a verdict. 14 Anything else we should take up at this time? 15 MR. VICKERY: I don't think so, Your Honor. 16 MR. SEE: No, Your Honor. 17 THE COURT: We'll recess at this point. 18 (Whereupon, the proceedings were adjourned at 19 3:10 p.m. to be reconvened at time of verdict.) 20 21 22 23 24 25 2784 1 C E R T I F I C A T E 2 --ooOOoo-- 3 I, TINA M. STUHR, Official Court Reporter, 4 United States District Court, District of Hawaii, 5 Honolulu, Hawaii, do hereby certify that the foregoing 6 is a correct partial transcript of proceedings in 7 Civil No. 95-00185ACK, Susan K. Forsyth, et al. vs. 8 Eli Lilly and Company, et al., at Honolulu, Hawaii, on 9 March 31, 1999, before the Honorable Alan C. Kay, 10 United States District Judge. 11 DATED: January 5, 2000. 12 13 ______________________________________ TINA M. STUHR, RPR, CSR #360 14 15 16 17 18 19 20 21 22 23 24 25