2610 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 2,610 - 2,625 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 hearing on 16 Tuesday, March 30, 1999 at 1:30 p.m. at Honolulu, 17 Hawaii. 18 BEFORE: THE HONORABLE ALAN C. KAY 19 United States District Judge District of Hawaii 20 21 REPORTED BY: TINA M. STUHR, RPR, CSR #360 Notary Public, State of Hawaii 22 PACIFIC REPORTING SERVICES UNLIMITED, INC. 23 733 Bishop Street Suite 2090, Makai Tower 24 Honolulu, Hawaii 96813 (808) 524-PRSU 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2611 1 APPEARANCES: 2 For Plaintiffs: ANDY VICKERY, ESQ. Vickery & Waldner 3 2929 Allen Parkway Suite 2410 4 Houston, Texas 77019 5 ROY K.S. CHANG, ESQ. Shim & Chang 6 333 Queen Street Suite 900 7 Honolulu, Hawaii 96813 8 For Defendant: ANDREW SEE, ESQ. Shook, Hardy & Bacon L.L.P. 9 One Kansas City Place 1200 Main Street 10 Kansas City, Missouri 64105 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2612 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 afternoon, Your Honor. Andy 4 Vickery and Roy Chang for the plaintiffs. 5 THE COURT: Good afternoon. 6 MR. SEE: Good afternoon, Your Honor. Andy See 7 for Eli Lilly and Company. 8 THE COURT: Good afternoon. First on the 9 verdict, you both agreed on this form of verdict? 10 MR. VICKERY: Yes, we did. 11 MR. SEE: We did. 12 THE COURT: I think there ought to be a gap in 13 this line here otherwise they don't know really 14 whether they're checking off on the plaintiffs or the 15 defendants. 16 MR. VICKERY: Right. Down the middle, the 17 line? 18 THE COURT: Right. 19 MR. VICKERY: I agree. 20 THE COURT: Do you agree with that, Mr. See? 21 MR. SEE: That would be fine. In fact, I had 22 contemplated using forms of verdict like that before 23 and just telling the jury what you need to do is write 24 it in of who you're finding for, but putting a gap in 25 the line makes a lot of sense. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2613 1 THE COURT: Then they've got to write the whole 2 plaintiffs, Susan K. Forsyth and William F. Forsyth, 3 Jr.? 4 MR. VICKERY: How about if you just put it in 5 an instruction that said, please write either Forsyths 6 or Lilly? 7 THE COURT: Or P or D. 8 MR. VICKERY: I don't want to be fighting at 9 the bench about whether a letter is a P or a D. 10 THE COURT: I'm ready to rule now on the last 11 two instructions, and I'm going to -- as far as 215, 12 the standard of whether it was known or knowable in 13 light of the generally recognized and prevailing best 14 scientific and medical knowledge available at the time 15 of the manufacture and distribution, I'm going to give 16 that instruction, recognizing that we don't have any 17 Hawaii law directly on point, but the parties did 18 stipulate in this case that Prozac is an unavoidably 19 unsafe product as that term is used in Comment K of 20 Section 402A of the Restatement 2nd of Torts. 21 And Comment K states that there is a special 22 category for unavoidably unsafe products, particularly 23 prescription drugs, and it goes on and concludes by 24 saying, "with a known, but apparently reasonable risk: 25 using the word known. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2614 1 And Comment J, which plaintiffs are asserting 2 should be used with respect to Instruction 57, itself 3 says, "not only that where warning is given the seller 4 may reasonably assume that it will be read and 5 heeded." It says earlier on in Comment J, "The seller 6 is required to give warning against it if he has 7 knowledge or by the application of reasonable 8 developed human skill and foresight should have 9 knowledge of the presence of the ingredient and the 10 danger." 11 And the fourth line said that the Hawaii 12 Supreme Court frequently follows California law, and 13 in the Anderson versus Owens Corning Fiberglass 14 Corporation, the Court stated, "Thus while a 15 manufacturing or design defect can be evaluated 16 without reference to the conduct of the manufacturer, 17 the giving of a warning cannot and the latter 18 necessarily requires a communicating of something to 19 someone. How can one warn of something that is 20 unknowable?" 21 And then in the Carlin case which plaintiffs 22 have directed the Court to with respect to California 23 reliance on Comment J, the California court states, 24 "Similarly, a manufacturer cannot escape liability 25 under strict liability principles merely because its PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2615 1 failure to warn of a known or reasonably 2 scientifically knowable risk conformed to an 3 industry-wide practice of failing to provide warnings 4 that constituted the standard of reasonable care." 5 And then they footnote and say, "In Anderson, we 6 explained that our definition of constructive 7 knowledge, i.e., what is reasonably scientifically 8 knowable is derived from the Restatement 2nd of Torts 9 Section 402A, Comment J. Which refers to knowledge 10 obtainable by the application of reasonable developed 11 human skill and foresight." 12 Now, the Hawaii courts on the one hand, we have 13 some federal Hawaii asbestos cases which state that 14 the state-of-the-art evidence is inadmissible, but the 15 Hawaii Supreme Court, to which a question was referred 16 by the Ninth Circuit to be certified, the Hawaii 17 Supreme Court in that case, the Johnson case, 18 specifically noted that it did not address the duty to 19 warn, although the Ninth Circuit took this and 20 extended it to that anyway. 21 On the other hand, in the 1997 case of Tabieros 22 (phonetically) versus Bark Equipment Company, the 23 court -- Hawaii court stated, "However, the appellate 24 courts" -- this is the Supreme Court of Hawaii. 25 However the appellate -- let me start earlier here. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2616 1 "A duty to warn of latent defects in a product 2 arises under both negligence and strict liability 3 theories. However, the appellate courts in this 4 jurisdiction have repeatedly recognized that a 5 manufacturer's duty to warn only extends to known 6 dangers which the user of the manufacturer's product 7 were not ordinarily discovered." Citing to Mysaki and 8 also citing to Ontai. 9 And that this Hawaii Supreme Court of 1997 also 10 states that "The Court should extend the analysis to 11 include the risk utility test." Of course if the -- 12 that test would -- necessarily would seem to require 13 to be measured by the known risk. 14 So the Court will -- I should also say the 15 Larsen decision, which is a Hawaii decision, discusses 16 Comment K which refers to knowable dangers. 17 Now, with respect to Instruction 57 -- 18 MR. VICKERY: Excuse me, Your Honor, before you 19 go to 57, I realize I've lost on 215, and I'm not 20 going to ask the Court to reconsider that at all, but 21 I wondered whether or not the Court might be willing 22 to take out the words "generally recognized and 23 prevailing best," so that it would just read "in light 24 of the scientific and medical knowledge available at 25 the time of the manufacture"? PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2617 1 THE COURT: Mr. See. 2 MR. SEE: I guess my inquiry would be, why take 3 that out? I mean, I could see a couple things about 4 it. If the reason to take it out is to be able to 5 argue something other than what the best scientific 6 knowledge was, then I think that's an illegitimate 7 reason to take it out. 8 I mean, from my experience, the standard is the 9 manufacturer is held to know what was knowable, and I 10 think that pretty clearly says what that is. I mean, 11 as the Court knows, exactly out of the California 12 pattern instruction, I doubt Mr. Vickery wants to 13 lower the standard applicable to my client, so it 14 makes me a little uneasy that if you take that out, 15 then the argument can be, well, you have to give 16 warnings based on this sort of science that doesn't 17 really rise up to the level of what is the best 18 prevailing scientific knowledge, and I think that's an 19 illegitimate argument so I would oppose taking it out. 20 If that's -- I'm not attributing that, but that would 21 be my concern. 22 MR. VICKERY: The reasons are twofold, Your 23 Honor. One is the phrase "generally recognized" 24 sounds remarkably like generally acceptable, sounds 25 like Fry versus United States which was rejected by PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2618 1 the Supreme Court in Daubert. I pointed out in our 2 pleading on this, the anomaly between being able to 3 adduce expert testimony that's not generally 4 acceptable within the scientific community and then, 5 in effect, telling the jury to disregard it. That 6 seems to be an anomaly. 7 The second reason is that when you use the 8 words "prevailing best," it suggests that the duty to 9 warn -- that Lilly has the prerogative to decide what 10 is the best science or not, and under the federal 11 regulation, which I put up on the screen and read, 12 their duty to warn arises whenever there is a, quote, 13 reasonable association of causation, and it says you 14 don't even have to wait for proof for causation. 15 So to suggest that their duty to warn arises 16 only when the prevailing best scientific evidence 17 establishes it, runs contrary to the federal 18 regulations which are in evidence in this case. Those 19 are the two reasons for the request that that phrase 20 be deleted. 21 MR. SEE: With respect, Your Honor, having 22 heard that, I don't think that makes any sense at all. 23 What this standard does is it holds Lilly to whatever 24 the best medical knowledge is, the best medical 25 knowledge available, and that's the standard that PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2619 1 Comment K requires. 2 THE COURT: All right. What if we say in light 3 of the best scientific and medical knowledge 4 available? 5 MR. SEE: Again, it would be my request that 6 the language in the instruction be given. What the 7 Court has proposed is far superior to what Mr. Vickery 8 proposes, but I would request the language that was 9 proposed be given. 10 THE COURT: Mr. Vickery. 11 MR. VICKERY: Your Honor, I think the decision 12 the Court has made is that this is to -- the standard 13 is one of the actual more constructive knowledge of 14 Lilly, and so when you tell them that the danger was 15 known or knowable in light of the scientific and 16 medical knowledge available at the time, that is a 17 plain vanilla instruction that goes neither to the 18 plaintiffs nor the defendants. Mr. See can argue his 19 side of that, and I can argue my side of it, and it's 20 right square down the middle. When you put any of 21 these other verbs in there, generally recognized or 22 prevailing best -- I'm sorry, they're not verbs. 23 They're adjectives, I guess, and adverbs, but when you 24 put those in, it tends to take it off the middle keel 25 and lean towards Lilly's side. PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2620 1 MR. SEE: With respect, this is the instruction 2 approved by the California Supreme Court. It's in the 3 standard pattern instruction book. I don't believe it 4 leans toward any side. It puts a high standard on the 5 drug manufacturer. And so I would request that Your 6 Honor give it as it's set forth. 7 THE COURT: Mr. Vickery, are you willing to go 8 with the best scientific and medical knowledge 9 available? 10 MR. VICKERY: I don't like it, but I'm willing 11 to go with it. 12 THE COURT: Mr. See. 13 MR. SEE: As I said before, my position is 14 that's a far superior and more correct statement than 15 the one Mr. Vickery proposes. 16 THE COURT: Because Daubert does definitely say 17 or its progeny definitely does say it doesn't have to 18 be generally recognized, so I will delete those words, 19 generally recognized and prevailing. 20 MR. SEE: I would submit, Your Honor, the 21 Daubert standard goes to admissibility. It doesn't go 22 to the standard of what the manufacturer is held to 23 comply to. 24 THE COURT: Well, it hasn't yet. 25 MR. VICKERY: How about putting in the word PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2621 1 reasonable instead of best. That's what the CFR uses, 2 Your Honor. It says there's a reasonable scientific 3 association, not the best one. 4 THE COURT: Well, the best holds Lilly to the 5 highest standard. 6 MR. VICKERY: Well, that's one view of it. The 7 other is to say that Lilly can -- that Lilly can 8 choose and pick in between scientific evidence when -- 9 the significance of it is under the federal 10 regulations -- 11 THE COURT: If you want to say that they 12 choose, then you ought to go back to generally 13 recognized because then they can't choose. 14 MR. VICKERY: Well, I'll take best rather than 15 going back to generally recognized. I will do that. 16 THE COURT: All right. On Instruction 57, the 17 heeding warning -- the heeding of the presumption, the 18 Comment J, under the facts and the evidence of this 19 case and the Carlin decision which noted that the 20 standard of known and reasonably scientifically 21 knowable risk be derived from Comment J, and the 22 Hawaii rules and underlying social policies involved 23 in Hawaii strict liability, I will give that 24 instruction. But it will have to be modified from 25 what we gave you earlier to insert, would have been PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2622 1 heeded by Dr. Roberts and Dr. Neal -- 2 MR. VICKERY: Okay. 3 THE COURT: -- in the second sentence. 4 MR. VICKERY: Fine. 5 THE COURT: Now, I guess that also takes us to 6 Lilly's motion to exclude certain matters from final 7 argument, Page 5, and with the Court's ruling that it 8 will give Instruction 215, it would seem likewise that 9 there should be a limitation that in evaluating 10 whether Lilly provided adequate warnings concerning 11 Prozac to prescribing physicians, the jury may only 12 consider alleged risks associated with Prozac of which 13 Lilly knew or should have known in February of 1993. 14 Anything else? 15 MR. VICKERY: Actually, there is one thing, 16 Your Honor. Mr. See and I discussed yesterday 17 afternoon the fact that since we both agreed that the 18 Court's instructions would be read before we argued, 19 that it might be a good cost-saving or time-saving 20 mechanism if we simply made our formal objection to 21 the charge on the record right now and that way -- 22 THE COURT: Formal objection? 23 MR. VICKERY: Yes, sir. I mean, to the extent 24 that you're inclined to hear any -- I know that both 25 sides have written papers and we've discussed them at PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2623 1 length in the charge conference yesterday and today, 2 but if you wanted any kind of further objections to 3 clarify or preserve the points, we can tick them off 4 now. If the Court feels like the record is adequately 5 protected on that, I feel -- 6 THE COURT: Do you have any objections to these 7 instructions that I spent so much time on? 8 MR. VICKERY: I don't have any new ones, Your 9 Honor. For example, I clearly object to giving that 10 215 Paragraph B at all for the reasons we discussed at 11 length yesterday. And, for example, I clearly object 12 to the Court's decision made previously not to submit 13 a 402B instruction to the jury or an instruction that 14 there is a duty to warn the patients directly. 15 These are all matters that we've discussed at 16 length and the Court's rejected. I'm just protecting 17 my record by reiterating. That is my position in 18 spite of the fact that I've lost those issues. 19 THE COURT: All right. So noted for the Ninth 20 Circuit. 21 Anything else? 22 MR. SEE: I would simply note for the record, 23 Your Honor, that Lilly objects to the heeding 24 instruction, as I think is very clear on the record. 25 THE COURT: Well, I guess that means that, PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2624 1 perhaps, one of you will be right and we'll see you 2 all again in another year or so. 3 MR. VICKERY: Don't say that. 4 THE COURT: We'll see you at nine o'clock 5 tomorrow. 6 MR. VICKERY: Thank you, Your Honor. 7 (Whereupon, the proceedings were adjourned at 8 2:00 p.m. to be reconvened on Wednesday, 9 March 31, 1999 at 9:00 a.m.) 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU 2625 1 C E R T I F I C A T E 2 --ooOOoo-- 3 I, TINA M. STUHR, Official Court Reporter, 4 United States District Court, District of Hawaii, 5 Honolulu, Hawaii, do hereby certify that the foregoing 6 is a correct partial transcript of proceedings in 7 Civil No. 95-00185ACK, Susan K. Forsyth, et al. vs. 8 Eli Lilly and Company, et al., at Honolulu, Hawaii, on 9 March 30, 1999, before the Honorable Alan C. Kay, 10 United States District Judge. 11 DATED: December 29, 1999. 12 13 ______________________________________ TINA M. STUHR, RPR, CSR #360 14 15 16 17 18 19 20 21 22 23 24 25 PACIFIC REPORTING SERVICES UNLIMITED, INC. (808) 524-PRSU