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