August 31, 2015 1 SUPERIOR COURT OF NEW JERSEY ATLANTIC COUNTY/CIVIL DIVISION 2 REGINA JACKSON, 3 Plaintiff, 4 v. 5 6 MCNEIL-PPC-INC., MCNEIL CONSUMER HEALTHCARE, and JOHNSON & JOHNSON, INC., 7 Defendants. 8 9 10 DAVID L. TAYLOR, a surviving spouse and closest of kin of LINDA TAYLOR, deceased, 11 Plaintiff, v. 12 13 MCNEIL-PPC-INC., MCNEIL CONSUMER HEALTHCARE, and JOHNSON & JOHNSON, INC., 14 Defendants. : : : : : : : : : : : : : : : : : : : : : : : : - ATL-L-880-13 ____________________ ATL-L-8575-11 ____________________ STENOGRAPHIC TRANSCRIPT OF: KEMP HEARINGS 15 PLACE: ATLANTIC COUNTY COURTHOUSE 1201 BACHARACH BOULEVARD ATLANTIC CITY, NJ 08401 DATE: AUGUST 31, 2015, 9:30 AM 16 17 18 B E F O R E: 19 THE HONORABLE NELSON C. JOHNSON, JSC 20 TRANSCRIPT ORDERED BY: 21 22 23 24 25 Butler Snow Seeger Weiss - - MICHELLE L. GRAY, CCR, RPR, CSR GOLKOW TECHNOLOGIES, INC. 877.370.3377 ph 917.591.5672 fax deps@golkow.com Golkow Technologies, Inc. Page 1 August 31, 2015 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 APPEARANCES: ASHCRAFT & GEREL, LLP BY: CHRISTOPHER V. TISI, ESQUIRE 4900 Seminary Road, Suite 650 Alexandria, VA 22311 (703) 931-5500 cvtisi@aol.com Representing the Plaintiffs HENRY SPIEGEL MILLING, LLP BY: R. CLAY MILLING, ESQUIRE 950 East Paces Ferry Road Suite 2450 Atlanta, Georgia 30326 (404) 832-8000 rcm@hsm-law.com Representing the Plaintiffs SEEGER WEISS, LLP BY: MOSHE HORN, ESQUIRE 77 Water Street New York, New York 10005 (212) 584-0700 mhorn@seegerweiss.com Representing the Plaintiffs BUTLER SNOW, LLP BY: MICHAEL B. HEWES, ESQUIRE 1300 25th Avenue, Suite 204 Gulfport, MS 39501 (228) 864-1170 Michael.Hewes@butlersnow.com Representing the Defendants -And- Golkow Technologies, Inc. Page 2 August 31, 2015 1 APPEARANCES: (Cont'd.) 2 3 4 5 6 7 BUTLER SNOW, LLP BY: TAYLOR B. MAYES, ESQUIRE BY: G. BRIAN JACKSON, ESQUIRE The Pinnacle at Symphony Place 150 3rd Avenue South, Suite 1600 Nashville, Tennessee 37201 (615) 651-6700 taylor.mayes@butlersnow.com brian.jackson@butlersnow.com Representing the Defendants 8 9 10 11 12 13 14 MCCARTER & ENGLISH, LLP BY: DAVID KOTT, ESQUIRE 100 Mulberry Street Four Gateway Center Newark, New Jersey 07102 973-639-2056 dkott@mccarter.com dkaufman@mccarter.com Representing the Defendants 15 16 17 18 19 ALSO PRESENT: Deborah A. Kaufman (Paralegal - McCarter English) Court Clerk: Jessica Rodeo 20 - - - 21 22 23 24 25 Golkow Technologies, Inc. Page 3 August 31, 2015 1 - 2 3 THE CLERK: - - All rise. The Honorable Nelson C. Johnson presiding. 4 THE COURT: Good morning. Everybody have a 5 seat. 6 their students where they needed to be or children, 7 everybody in school? 8 Everybody have a good weekend? 9 10 11 MR. MILLING: Everybody get Everybody is in school. Everybody hopefully got to spend a little time with the family. THE COURT: I'll ask Mr. Kott again to give 12 us the two docket numbers for these cases, because all 13 I had with me is on my notice. 14 MR. KOTT: The Jackson docket number is 15 ATL-L-880-13, and the Taylor docket number is -- 16 Ms. Kaufman is going to tell me in a second. 17 Taylor is ATL-L-8575-11. 18 THE COURT: 19 Counsel, enter your appearances, please. 20 MR. MILLING: 21 Thank you, Mr. Kott. For the plaintiff, Clay Milling, Henry Spiegel Milling for the plaintiffs. 22 MR. TISI: Chris Tisi, Ashcraft & Gerel. 23 MR. HORN: Moshe Horn, Seeger Weiss. 24 25 Good morning, Your Honor. MR. KOTT: Golkow Technologies, Inc. David Kott, McCarter & English. Page 4 August 31, 2015 1 Behind me, Brian Jackson. 2 3 And, Your Honor, before we start arguing, we just want to talk about some of this pro hoc. 4 5 MR. MAYES: I'm sorry. Taylor Mayes, Your Honor, Butler Smith. 6 MR. HEWES: 7 MR. KOTT: Michael Hewes, Your Honor. Everyone who's argued before you 8 has been admitted pro hoc in one of the New Jersey 9 cases. I'm not sure -- actually, I am sure that some 10 have not been admitted in Jackson. 11 whether the Court wanted separate orders for each case 12 or not. 13 THE COURT: And I didn't know I don't think it's necessary. 14 I'll acknowledge -- Mr. Mayes, you are not admitted in 15 the -- 16 MR. MAYES: Your Honor, I think I'm 17 admitted in the Taylor case, not in the Jackson case, 18 but I also am admitted in several of the other New 19 Jersey cases. 20 submit it -- 21 22 THE COURT: 25 I think we can If anybody thinks it's necessary to submit an order, that's fine by me. 23 24 But we do have an order. MR. KOTT: I'll be guided by what Your Honor wants. MR. MILLING: Golkow Technologies, Inc. We certainly don't think it's Page 5 August 31, 2015 1 necessary, and we're happy to have them. 2 THE COURT: My game plan, because I've got 3 to -- I want to introduce my law clerk for this court 4 session, Jessica Rodeo. 5 deal with. 6 size. 7 industrious and very bright. 8 working with me, and I think you'll find her a pleasure 9 to deal with. You'll find her a pleasure to Don't be taken aback by her diminutive She is a fireball, and one with energy and very 10 I'm honored to have her What I have done with Jessica's help is 11 basically prepared a list that I think we can run right 12 through them, because, you know, some of this is 13 territory we've covered in the past. 14 proclivity sometimes in these matters to say to defense 15 counsel, why don't you keep a list, because I'm working 16 on the other ruling, and I'll have the other ruling to 17 the expert testimony to you by the end of the day 18 tomorrow. 19 And I have a But on this one, I think what we can do, 20 and we'll have the transcript to help us, we can simply 21 run through the motions. 22 sometimes prepare these things because I know they are 23 getting paid, and I know you guys are on contingency. 24 I say let the defense counsel prepare these things. 25 Obviously, you'll have input, and I'll have input. Golkow Technologies, Inc. And I ask defense counsel to Page 6 August 31, 2015 1 If Mr. Kott gets anything wrong -- but he 2 usually doesn't, and I'll rely upon him to prepare the 3 order, again with the benefit of the transcript, and I 4 think we can go right through this. 5 we'll take whatever breaks we need to take, but 6 hopefully we'll get it all resolved today. 7 You know, again, Beginning with plaintiffs' motions, and how 8 I think I want to handle these is probably say to one 9 side or the other, tell me why I shouldn't rule a 10 certain way; tell me why I shouldn't grant; tell me why 11 I shouldn't deny it. 12 more discussion than most, but most won't require a lot 13 of discussion, I don't think. 14 Some of these will require a lot So let's begin with plaintiffs' omnibus 15 motion with regard to Taylor. 16 we want to do is resolve all the motions for each case; 17 and then if Jackson settles or, you know, Taylor comes 18 up quickly afterwards, we won't have to go through this 19 again. 20 MR. MILLING: I think we agreed what Your Honor, good morning. 21 The omnibus motion has, as your Your Honor is aware, as 22 defense counsel is aware, a number of individual, very 23 small motions -- 24 THE COURT: 25 MR. MILLING: Golkow Technologies, Inc. I know. -- most of which were granted Page 7 August 31, 2015 1 last week -- last year. 2 into the record. 3 objection -- 4 5 What I suggest is I read them If the defense counsel has an THE COURT: What I want -- you can have a seat. 6 What I want to do is get started. I've got 7 a list, which I'm pretty sure is accurate. 8 to do is just run through them and then say, one side 9 or the other, tell me why I shouldn't be granting it. 10 So the first one is, exclude reference to 11 verdicts of adverse impact on pharmacy -- any adverse 12 impact of verdicts on the pharmaceutical industry 13 ability to get medications, stock value of publicly 14 traded pharmaceutical company, et cetera. What I want 15 Defense, tell me why I shouldn't grant it. 16 MR. KOTT: 17 I think you should grant it, Your Honor. 18 THE COURT: 19 Next one, exclude arguments concerning how Thank you. 20 plaintiff chose counsel. 21 it. 22 23 MR. KOTT: That makes it easy. Tell me why I shouldn't grant The Court is going in a little different order than -- 24 THE COURT: 25 MR. KOTT: Golkow Technologies, Inc. I'm sorry. -- than the motion -- than they Page 8 August 31, 2015 1 were briefed. It will take me a moment. 2 MR. MILLING: 3 THE COURT: I think you grouped a bunch. I did. But I'm trying to 4 get -- again, we know what the issue is. 5 I grant that? 6 7 MR. KOTT: 10 I think you would grant that, Your Honor. 8 9 Why wouldn't THE COURT: Okay. financial status of counsel. Exclude records to Why wouldn't I grant that? 11 MR. KOTT: I think you would, 12 provisionally, unless there is some comment by 13 plaintiffs' counsel that they are mismatched, meaning, 14 gee, these guys -- 15 THE COURT: 16 MR. KOTT: 17 THE COURT: 18 Well, I couldn't agree more. And the other thing -And you know what he's alluding to. 19 MR. MILLING: 20 THE COURT: Absolutely, Your Honor. If you sit there, we're just 21 humble contingent fee lawyers and we've got heavy guns 22 from Fortune 500 companies. 23 and we're doing our best on behalf of our client. 24 25 MR. MILLING: We're really overwhelmed, Even if it's true, we won't say it. Golkow Technologies, Inc. Page 9 August 31, 2015 1 2 THE COURT: Well, I don't think we need any references by counsel to either side. 3 MR. MILLING: 4 THE COURT: 5 I absolutely agree. Okay. possibility and ability of defendants to pay verdict. 6 MR. KOTT: Agreed. 7 THE COURT: Okay. 8 MR. KOTT: 10 Agree. THE COURT: 11 damages are unlawful. 12 MR. KOTT: 13 THE COURT: issue. Exclude reference that punitive Well, I think that -Punitive damages is not an It's not an issue. 15 MR. MILLING: 16 THE COURT: 17 It's moot. Okay. It's moot. Glad we all agree. 18 19 Exclude reference to pre- or post-judgment interest. 9 14 Exclude reference to Exclude any mention of lawyer-driven litigation. 20 MR. KOTT: Agreed. 21 THE COURT: Okay. Exclude any reference to 22 any books, seminar, and educational materials for 23 plaintiffs' attorneys. 24 MR. KOTT: Agreed. 25 THE COURT: Okay. Golkow Technologies, Inc. Exclude any reference Page 10 August 31, 2015 1 that plaintiff may be covered by insurance. 2 MR. KOTT: Agree. Well, Your Honor, let me 3 go back on that one, because we know under the New 4 Jersey statutes, the fact that plaintiff -- and 5 plaintiff, as I understand it, is an employee -- I'm 6 now referring to Jackson -- is an employee of the State 7 of New Jersey. 8 9 10 THE COURT: Let's stay with Taylor. You're going to get your chance to talk about Jackson. I want the record to be coherent. 11 12 MR. KOTT: Okay. We're talking about Taylor. 13 THE COURT: So, again, exclude any 14 reference that plaintiff is covered by insurance. 15 agree? 16 MR. KOTT: I think I do. You And I would just 17 want to check that Oklahoma does not have a similar 18 statute to New Jersey that health insurance bills, 19 if -- no double recovery. 20 THE COURT: I'm going to grant it. And if 21 you feel you need to brief that issue, we can talk 22 about it later. 23 Exclude current and former employee 24 character evidence. 25 issue at some point, depending upon the testimony that Golkow Technologies, Inc. Character can always become an Page 11 August 31, 2015 1 we hear. 2 grant the motion subject to somebody raising it later. 3 But generally, you know, my inclination is to 4 In this case, I don't see it being an issue on Taylor. 5 But... MR. KOTT: And our view would be that would 6 be determined by 404(a). 7 our witnesses, depending upon what attacks are made on 8 our witnesses that may call into play on both cases on 9 404(a). 10 11 12 THE COURT: And I'm now concerned about Okay. Well, again, I'm going to grant the motion subject to what may arise at trial. Exclude any mention that design defect or 13 failure-to-warn laws pressured defendants to dilute or 14 invalidate warnings. 15 because, again, I'm inclined to grant that. 16 me why I shouldn't. 17 MR. KOTT: Let's talk about that one, But tell Because -- and I'm going to stay 18 on Taylor, which is a warnings case -- one of the 19 defenses to the claim that the warning is inadequate is 20 if you put too many warnings on a product, the consumer 21 is less likely to read it. 22 the reasonableness of our conduct, meaning negligence 23 in Taylor, or judging whether the warning is defective, 24 we should be allowed to offer evidence -- and we've 25 given to the Court in papers scientific papers done by Golkow Technologies, Inc. So, therefore, when judging Page 12 August 31, 2015 1 people who have done empirical testing that have said, 2 if you give too many warnings, people won't read any of 3 them, and then the product will be less safe. 4 So I think that's fair game for us, because 5 it's a defense to their claim, well, you should have 6 added this warning, you should have added that warning, 7 you should have added that warning. 8 lawnmower 60-page owner's manual which nobody reads. 9 I'm exaggerating when I say that. 10 THE COURT: 11 MR. MILLING: I know. Mr. Milling? Actually, I was just asking 12 Mr. Horn. 13 working on the plaintiffs' motion? 14 THE COURT: 15 Is this a defense motion, or are you still When I -- I'm going to keep this record very clear. 16 This is plaintiffs' motions on Taylor, is 17 what we are talking about right now. 18 MR. MILLING: 19 the motion. 20 pulling up his notes. 21 And now we have a Mr. Horn is going to argue But I'll address one point while he is As to the length of the warning, the 22 monograph within the actual tentative final monograph 23 and within the regulations and within the expert 24 testimony allows for, even an over-the-counter, a 25 package insert. So the length of the warning is not a Golkow Technologies, Inc. Page 13 August 31, 2015 1 valid argument out of defense. 2 that clear. 3 MR. HORN: I just want to make Just to my point, Your Honor, I 4 would ask that if Your Honor wants to retain this 5 motion, I think it's premature, because I think it's -- 6 THE COURT: 7 MR. HORN: It may be. We don't exactly know what the 8 issue Mr. Kott is discussing is and what experts may or 9 may not say. 10 Maybe that's the kind of thing we'll deal with at a 104 or a sidebar or whatever. 11 But just briefly to respond to his comment, 12 if his point is they are going to say nothing could be 13 safe or the label should be ten pages long, it strikes 14 me that's a generic pharmaceutical, industrywide 15 argument. At that point, it's irrelevant. 16 What should be coming into play in this 17 case is what the Tylenol label should have said and 18 what the design defect was, and not some sort of 19 sweeping industrywide issue of a ten-page-long label. 20 But nevertheless, I think that's the kind 21 of issue that's probably best dealt with in the 22 specific fact that arises at trial that we all can 23 discuss. 24 25 THE COURT: I agree with you. So my inclination is to neither grant nor deny. Golkow Technologies, Inc. Page 14 August 31, 2015 1 2 Next, exclude any mention that state tort law undercuts FDA's mission. 3 MR. KOTT: 4 this caveat: 5 all over the case. 6 understand. 7 I think we agree with this, with The FDA is all over the case. I mean, It's a little hard in a vacuum to I don't -THE COURT: I think that I have to deny 8 that, but deny it with the caveat that FDA -- I think 9 each one of you may decide to use FDA as a sword and 10 maybe even a shield. 11 that. 12 use it as a sword. I don't see the plaintiffs doing But the defendants might. 13 But they might also And we may have to at some point agree upon 14 a charge or charges that would be cured while they're 15 hearing testimony so that they understand the role of 16 the FDA. 17 The role of the FDA is enormous. MR. TISI: Judge -- Your Honor, the point 18 that I think is being made by this motion is not 19 whether the FDA is involved in this case or not. 20 question is whether or not there should be argument 21 that, if you render a verdict in this case, you're 22 undercutting the safety of medications because you are 23 undercutting the FDA's ability to regulate medicines. 24 25 THE COURT: The I think the jury will understand from me that that's not the case. Golkow Technologies, Inc. Page 15 August 31, 2015 1 MR. TISI: And that's why we have the 2 motion, because, in fact, the Supreme Court has said in 3 the Wyeth case -- 4 THE COURT: The state of the law in our 5 nation is that it's a process that the FDA oversees 6 nationally, but each state can say what they think is 7 best for their citizens. 8 9 MR. TISI: That's right. And so the state -- so we believe that the motion should be 10 granted, because we don't want any inference in some 11 fashion that what a jury does in the State of New 12 Jersey or Nevada or any other place undercuts the -- 13 THE COURT: My inclination is to grant it, 14 but we all need to understand that we're going to be 15 talking about the role of the FDA, because we're going 16 to get to that conversation -- we're going to get to 17 that conversation shortly. 18 get to reprise his arguments on GRASE, and then we'll 19 go on to the next issue. 20 MR. MILLING: 21 And Mr. Milling is going to I've got a lot of notes here, but I don't have anything about GRASE, or GRASE. 22 THE COURT: 23 So I'm going to grant that motion with the We do later on. 24 understanding that at some point we're going to have to 25 talk about the FDA, so that the jurors understand just Golkow Technologies, Inc. Page 16 August 31, 2015 1 what their role is vis-à-vis the states. 2 MR. TISI: And the role may be depending 3 upon -- I mean, in the pure design defect case -- I 4 know we're dealing with Taylor, but the design defect 5 case, again, focuses on the product. 6 that the role of the FDA is going to be less in that 7 case than it would be in the warnings case. 8 9 THE COURT: I don't disagree with that. But that motion will be granted. 10 11 And so we think Exclude any mention that plaintiffs want Tylenol removed from the market. 12 MR. KOTT: Well, to the extent that the 13 plaintiffs are arguing that the design -- the design is 14 defective in Taylor and we should have some other 15 product, which is exactly what they did, I think it's 16 fair game in closing for our side, whomever is giving 17 the closing, which won't be me, but whomever is giving 18 to say, look, they're asking for you to find this 19 product defectively designed. 20 pay money. 21 products. 22 defectively designed in the real world, we're going to 23 have to remove it from the market. 24 25 They want us to have to And we're in the business of making If we have to pay money for a product that's So to the extent the plaintiffs are arguing a defective design, I think it's fair game in closing Golkow Technologies, Inc. Page 17 August 31, 2015 1 for us to argue that. 2 MR. MILLING: Your Honor, these were 3 prepared long before where we are now. 4 we withdraw this motion in limine. 5 THE COURT: 6 MR. MILLING: We actually -- Okay. I'll explain. Especially on 7 the design defect claim, I'll explain in some other 8 arguments today about conduct at instances where with 9 other -- where McNeil has noticed in other of its 10 products, a small risk, they have, in fact, withdrawn 11 the product from the market, as compared to the risk 12 that we're going to present as Extra Strength Tylenol. 13 So we would file that motion. 14 THE COURT: Yeah, I think if that argument 15 was made, some people might find it presumptuous. 16 you think about it, they'd likely say, "Really? 17 want to remove Tylenol from the market?" 18 MR. MILLING: the decision of the advisors to prescription. 20 from the market is out of the question. 22 You Well, and it also bleeds into 19 21 If THE COURT: Remove I take it the motion's withdrawn. 23 MR. MILLING: And not remove Tylenol. 24 We're just talking about extra strength versus regular 25 strength. We withdraw the motion. Golkow Technologies, Inc. Page 18 August 31, 2015 1 THE COURT: Okay. Exclude evidence of 2 defendants' reputation and good facts. 3 anything, really. 4 MR. MILLING: Not relevant to I think we talked about this 5 last time. 6 allowed to talk about how they may engage in charitable 7 endeavors, that they may do other things outside of 8 what the context of this is. 9 overboard about the mission of Johnson & Johnson and We don't think that the defendant should be That maybe going 10 public health, all the medicines that they put out, all 11 the good things -- 12 THE COURT: 13 Mr. Kott? 14 MR. KOTT: I agree with you. I think I'm back to 404(a) and 15 (b) where we need to see what the plaintiffs say about 16 McNeil. 17 THE COURT: Okay. Well, it'll be granted 18 for now subject to the defendants' ability to reply to 19 some of the things that you may raise. 20 21 22 23 24 25 Exclude gratuitous reference of plaintiff being out of state. Of course I'm going to grant that. Exclude any evidence of settlement negotiations. Of course I'm going to grant that. Defendants should be precluded from increasing pretrial advertising or publicity. Golkow Technologies, Inc. I know Page 19 August 31, 2015 1 that's not going to happen. 2 It's not going to happen. 3 MR. KOTT: That will be granted. Your Honor, may I be heard on 4 that? 5 to know whether we are going to increase it in the 6 Philadelphia or Atlantic City market. 7 And I'm not for a moment -- I'm too far removed THE COURT: In today's world, there's so 8 many channels that people can choose from in terms of 9 their media appetites. 10 11 I don't know how they could do it and it be even noticeable by anybody. MR. KOTT: I accept that, Your Honor. But 12 we get into a whole line of very strong U.S. Supreme 13 Court cases on prior restraints. 14 THE COURT: 15 MR. KOTT: I agree. And I think -- I remember 16 hearing Judge Reising, an appellate division judge, she 17 said, "Anytime a lawyer says 'respectfully,' I know the 18 next thing out of his mouth is disrespectful." 19 THE COURT: 20 MR. KOTT: I don't assume that. So I'm going to use 21 "respectfully," but I think what the Court just did is 22 enter a prior restraint. 23 understanding of the Supreme Court precedence, the 24 Court can do that. 25 THE COURT: Golkow Technologies, Inc. I don't think, based on my No, let me -Page 20 August 31, 2015 1 MR. KOTT: 2 THE COURT: 3 MR. KOTT: Just let me finish. Go ahead. There are plenty of other ways 4 that the Court can deal with it. 5 is jury selection, and an instruction to the jury, 6 "Look, if any Tylenol ad comes on, you're in the 7 presence, shut the TV off, walk out, stop talking." 8 The standard instructions you've given in a case. 9 What I'm referring to So the prior restraint is particularly a 10 problem when there are much less ways that you can 11 effectively deal with a case. 12 THE COURT: I think we agreed last time 13 that they would consent that it's just not going to 14 happen. 15 MR. MILLING: Again, I think the order last 16 time -- I think you asked counsel to check with the 17 client and make a representation to Your Honor at some 18 point that we are not, within a month before this 19 trial, going to increase our advertising, change our 20 advertising in an increased manner within a certain 21 area around Atlantic City, I think, when you go back 22 and look at the transcript. 23 with that. 24 25 THE COURT: But I think we all agreed Why don't we say that the motion's withdrawn because of the defendants' Golkow Technologies, Inc. Page 21 August 31, 2015 1 representations? 2 MR. MILLING: Yeah, if the defendant is 3 representing that we're just going with the status quo, 4 that's fine. 5 THE COURT: I've got more damn channels 6 than I know what the hell to do. 7 most of them are. 8 to remember when they talked about cable TV. 9 going to be free because you were paying for the cable I don't know what And you're probably all old enough It was 10 TV and so it was going to be free of advertisements. 11 That hasn't happened. 12 channels and I'm still getting advertisements. 13 about it. 14 would have to spend a fortune in order to have an 15 impact. 16 commercial on TV, to be honest with you. 17 It's crazy. I'm paying for all these damn Think How could they possibly -- they I can't remember the last time I saw a Tylenol MR. KOTT: I just can't make the 18 representation, just because I, David Kott, don't know, 19 and I doubt my colleagues -- 20 THE COURT: Well, I'm hoping at some point 21 within the next few days they'll be able to say, you 22 know, "McNeil has advised us that they plan no increase 23 over what they've been doing for how long." 24 MR. KOTT: 25 MR. HEWES: Golkow Technologies, Inc. That, we can do. Yes, Your Honor. Page 22 August 31, 2015 1 THE COURT: The Court should limit 2 defendants' ability to play their deposition 3 cross-designation during plaintiffs' case in chief to 4 only those portions, if necessary, pursuant to the 5 principles of fairness and completeness. 6 Let's talk about this, because, obviously, 7 they are going to become -- they may become relevant 8 depending upon what a witness says. 9 cross-examination. I permit broad 10 MR. MILLING: 11 The purpose of this motion, Your Honor, I remember you saying that. 12 is -- and, in fact, Your Honor, everybody has tried a 13 case; the plaintiff has the burden of proof. 14 And what we -- what the big picture is, we 15 believe that while we're trying to move the ball in our 16 burden of proof, that it is unfair for the defendants 17 to stack their evidence into our presentation. 18 19 20 THE COURT: I couldn't agree more. this conversation last year. MR. MILLING: We had It's not going to happen. Right. So with that caveat, 21 with that understanding, we have not -- for example, we 22 have served our deposition designations on the defense 23 almost two months ago. 24 may need to tweak them now that we're trying Jackson, 25 but we haven't received the responses. Golkow Technologies, Inc. We served them in the MDL. We Page 23 August 31, 2015 1 The first part of this motion, is, you 2 know, under Rule 4:16-1(d) in the New Jersey rules, a 3 party -- "When a writing or recorded statement is 4 introduced by the plaintiff, an adverse party may be 5 required" -- "may require the introduction at that time 6 of other parts of the writing or recorded statement 7 which in fairness ought to be considered 8 contemporaneously." 9 opposed to in their case. 10 That's what the rule is, as And so the first part of this motion is, we 11 hope that when we sit down with Your Honor and we get 12 defenses' counter-designations, that there's not a 13 counter-designation to every question we have 14 designated. 15 permits only -- 16 17 18 Because the rule doesn't permit that. THE COURT: It I'm confident that's not going to happen. MR. MILLING: Well, it kind of did last 19 year, respectfully, even though that means I'm going to 20 say something disrespectful. 21 The second part is, Your Honor, when we put 22 up -- each of the witnesses we're going to put up -- 23 all -- I would think almost everyone -- I can't think 24 of anybody off the top of my head, except for maybe 25 Colleen Goggins, who is the second in command at Golkow Technologies, Inc. Page 24 August 31, 2015 1 Johnson & Johnson -- is still an employee of Johnson & 2 Johnson. 3 from, maybe save for two or three, virtually all of 4 them started at McNeil and have risen to Johnson & 5 Johnson and they are still employees. 6 their control. 7 cross-examination of a party, of their employee for the 8 purposes of, A, proving our case; B, seeking admissions 9 from the deponent. All of these people that you're going to hear 10 They are under We are going to play a What we don't want to have happen is, in 11 our case, while we're trying to move the ball forward, 12 for the defense to then turn on the tape and play a 13 long direct examination that totally takes the winds 14 out of our sail when they could call that person live 15 in their case. 16 testimony while to just give a closing argument. 17 18 That is unfair to play 50 pages of THE COURT: Give me, I don't want to say context, but you're going to call a witness via video. 19 MR. MILLING: 20 ten witnesses via video. 21 example, if we call Dr. Ed Kuffner, and he'll be called 22 a few times, he was the medical director of McNeil from 23 2006 to 2012, right in the heart of this case. 24 we're going to play our cross-examination, parts of our 25 deposition. Golkow Technologies, Inc. We're going to call probably We'll cut them down. For And Page 25 August 31, 2015 1 And the Court should allow, for 2 completeness, and only if it should be played 3 contemporaneously, them to add into our 4 cross-examination of Dr. Kuffner a couple extra 5 questions here and there if they really needed to be 6 added in for context. 7 But then what happened at the end of the 8 deposition of Dr. Kuffner is whoever -- whatever lawyer 9 for the defense was handling it, turns the tape on 10 again and says, "Dr. Kuffner, state your name. 11 Michael Hewes or I'm Taylor Mayes from McNeil," and 12 asks softball direct questions that go on for 50 pages. 13 That -- we don't think that should be played during our 14 case in chief. 15 we're supposed to be trying to do, and we're allowed to 16 call corporate witnesses on cross. 17 long, lengthy direct, which is in essence like closing 18 argument because it's a friendly witness answering 19 questions from their lawyer, being played right after 20 that is patently unfair. 21 live. 22 testimony on, they can call him in their case. 23 what we're trying to avoid is 50 -- 24 25 I'm We've just advanced the ball, which And they can call Dr. Kuffner He's their employee. THE COURT: response to your video? Golkow Technologies, Inc. But then to have a If they want to put that And so What if they call him live in What if he's sitting here Page 26 August 31, 2015 1 while you are playing the video and then he takes the 2 stand? 3 4 MR. MILLING: That would be fine. Or, the way I've seen it happen is we play the video -- 5 THE COURT: You say that would be fine. 6 would say as much or as little as he needed to say on 7 their cross. He 8 9 MR. MILLING: He would do it in their case. If we call him in our case, we put up our testimony. 10 And then in their case, they call him live. 11 shouldn't be able to call him live and put on a 12 direct -- 13 THE COURT: Hold on. They We all know you run 14 the risk that when you call a witness -- and I'm 15 sympathetic to a degree, and I'm empathetic to a 16 degree, with, you know, competing videos. 17 you've got a video that goes on for a half an hour, and 18 then -- what's the name of the doctor? 19 MR. MILLING: 20 THE COURT: But if Dr. Kuffner. Okay. And you've got 21 Dr. Kuffner sitting there watching the whole video, and 22 I can see him smouldering, because he thinks you really 23 cherry-picked his testimony and he wants to take the 24 stand. 25 how many questions they ask of him. And they take the stand, I'm not going to limit Golkow Technologies, Inc. Why would I do Page 27 August 31, 2015 1 that? 2 MR. HORN: Your Honor, I think there's a 3 little bit of a miscommunication here. 4 think, what we're trying to say. 5 it to an extreme. 6 out of Dr. Kuffner was one question -- If we -- let's take Let's say the only thing we wanted 7 THE COURT: 8 MR. HORN: 9 Here's, I Sure. -- what date was something done -- 10 THE COURT: 11 MR. HORN: Correct. -- and that's it, then we don't 12 want them to be able to start from scratch with a 13 three-hour direct. 14 If Dr. Kuffner is sitting there and he 15 can't wait to get up there, by all means. 16 on their case. 17 Dr. Kuffner. 18 stand for a week if they want. 19 20 21 So we rest. Absolutely. THE COURT: But that's They stand up and call They can put him on the Then we cross. Look, every cross is limited by the scope of the direct. And so, again, I don't know to what extent 22 you're going to use video to, pardon the expression, 23 but trash a witness and make them look like something 24 they really aren't in the eyes of the other side. 25 so what's the best time to, you know, rehabilitate that Golkow Technologies, Inc. And Page 28 August 31, 2015 1 witness so the jury understands that they got a picture 2 that was something less than the person really is. 3 Right then and there, that's the time. 4 MR. MILLING: I guess the problem is, from 5 the plaintiffs' perspective, we think they should be 6 able to put on their case. 7 trashing. 8 They should be able to put their case, but they should 9 put their case on during their case in chief, not 10 It's going to be scientific discussion. during our case in chief. 11 12 Firstly, there's no THE COURT: their witness. 13 Yeah, but you chose to call There's your problem. You created the lineup. If you called 14 their witness, I mean, my inclination is their witness 15 gets to respond. 16 the direct. 17 But, again, subject to the scope of MR. TISI: 18 points. 19 mass tort case. Correct. And let me just -- two Number one is, this is kind of unique in a 20 THE COURT: 21 MR. TISI: I understand that. These depositions have been 22 taken. 23 because of the uniqueness of a pharmaceutical mass tort 24 case, is they do it in the way that Mr. -- I recently 25 had a case where we put on a half hour of the witness. And what I've seen judges do as a matter of -- Golkow Technologies, Inc. Page 29 August 31, 2015 1 They wanted to call the witness for a lot of other 2 purposes, and Judge Polster in the Northern District of 3 Ohio said, "That's fine. 4 in your case, or you can play your direct examination 5 in your case." 6 You can either call him live That's the way judges have handled it. And the other point I would make is, it's 7 not really unlike, for example, even a medical 8 malpractice case. 9 either an interrogatory or a deposition to set the 10 Sometimes we need evidence from groundwork for what an expert says. 11 You play that, you put it into evidence, 12 the expert can rely on it. 13 defendant from calling that witness in their case. 14 They'll -- 15 THE COURT: 16 MR. TISI: That doesn't prevent the Of course it doesn't. So what I think has happened in 17 the past, and I think judges have seen the abuses of 18 this, is that you do play -- you know, I've had a 19 witness call it stuffing the turkey. 20 a half hour from a witness, and then they stuff the 21 turkey with two hours' worth of testimony, so the jury 22 really misses the essence of what it is that the 23 plaintiff was trying to put the witness on for in the 24 first place. 25 You want to play And that's what we're trying to do. Golkow Technologies, Inc. We're Page 30 August 31, 2015 1 trying to make sure that our case is not diluted. 2 We're not in any way suggesting that they are not 3 entitled to put on a defense. 4 What we're saying is, don't dilute our 5 case. 6 videotape, as opposed to calling an adverse witness in 7 our case, don't dilute it by allowing them to stuff the 8 turkey. Don't force us, because we had to do this by 9 And I think that most MDL judges, most 10 judges that I've seen, have been very scrupulously 11 careful in dealing with this issue because it is a real 12 practical problem. 13 THE COURT: It is a practical problem 14 because so much of this testimony will be introduced by 15 video, but the only guide that I have right now -- and 16 I do want to hear from the defense. 17 have right now is let's circumscribe whatever gets 18 presented in counter to your, quote, direct. 19 to be limited by the scope of that direct. 20 The only guide I It's got And obviously it's going to take us some 21 time for me to either read transcripts or for me to 22 either look at video clips so I can say, okay, you put 23 your witness on for 30 minutes, and I think 15 minutes 24 is -- based upon what I'm hearing -- is all they need 25 to reply. Golkow Technologies, Inc. Page 31 August 31, 2015 1 Does the train going down the track get 2 slowed up for 15 minutes? 3 it. 4 MR. TISI: It sure does. I can't stop We're not in any way suggesting 5 that they can't put contextual information in. 6 all we're asking for, Judge. 7 8 That's THE COURT: Let's hear what Mr. Kott has MR. KOTT: First, let's go back to basics. got to say. 9 10 If he were called live and they dropped a subpoena on 11 Dr. Kuffner and they did an examination of him, right 12 then and there, we can cross within the scope. 13 uncontroverted that we can do that. 14 heard Mr. Tisi acknowledge that. 15 That's I think I even So, therefore, my rhetorical question is, 16 how could we be any worse off because they show a 17 video? 18 My next point is when the Court -- the 19 Court is going to control this, because you're going to 20 go over the dep readings. 21 our proposed counter-designations, almost every one of 22 them says, "Dr. Kuffner, do you remember you were asked 23 about what color the light was at the intersection? But when the Court does hear 24 "Yes. 25 "I have some questions about that, the Golkow Technologies, Inc. Page 32 August 31, 2015 1 color of the light." 2 So they're all in context. 3 And the third thing I'd say is what 4 Mr. Tisi asked you to do is exactly what one of your 5 brethren many years ago, a trial court judge, did in 6 Moksvold, M-O-K-S-V-O-L-D, v. Meyers, M-E-Y-E-R-S, 7 130 N.J. Super. 481, App. Div. 1974, where the 8 appellate division reversed the trial judges despite 9 the broad latitude that trial judges have, and despite 10 what the standard is on appeal, reversed the trial 11 judge because he or she did not allow cross within the 12 scope. 13 So I think it's easy. We get treated the 14 same, whether it's called live or video and we're 15 allowed to cross within the scope. 16 scope, we're back in Your Honor's anteroom and we're 17 talking about it, you're going to say, no, Mr. Hewes, 18 no, Mr. Mayes, I'm not going to let you ask that 19 question. 20 If we go beyond the It's beyond the scope. MR. TISI: It's not just that, Your Honor. 21 What happened last year is, we would designate -- I 22 would not disagree. 23 THE COURT: 24 MR. TISI: 25 I never got to see those. Well, in part you did start to rule on -- Golkow Technologies, Inc. Page 33 August 31, 2015 1 THE COURT: We -- you got cut short. 2 MR. TISI: What ultimately happened, 3 Judge -- Your Honor, is there really are two things. 4 In the cross-examination, Mr. Hewes would redirect, and 5 those questions, as Mr. Kott said, as long as they're 6 fairly within the scope and fairly well prescribed, I 7 would agree with him. 8 What I think would happen, they would -- is 9 they would go way and -- go beyond that in their cross. 10 The other part of it is, if I take a -- 11 many of these went for several days. 12 example, with Dr. Temple. 13 want to put an hours' worth of testimony in with him. 14 So two days, for I took him for two days. I The other stuff I decide, for whatever 15 reason, tactical reasons, responsiveness, whatever the 16 reasons happen to be, I decide not to play the other 17 ten hours of my direct. 18 Okay. Putting aside Mr. Hewes' cross, what 19 happens is I play my hour in front of the jury. 20 then take three hours of my continued direct 21 examination and put that in, not of their cross, not of 22 their redirect, but of my questions, which dilutes the 23 reasons why I called him in the first place. 24 25 They We all know that in real trial, if I was to call Dr. Temple at trial, I would have taken a Golkow Technologies, Inc. Page 34 August 31, 2015 1 five-hour deposition, seven-hour deposition of him. 2 might call him on the stand for an hour. 3 I To use Mr. Kott's thing in the real world, 4 they wouldn't be able to then force me to ask the 5 questions that I asked in a deposition of the witness 6 who was on the stand. 7 So what's really happening here, and what 8 happens in these cases if you don't carefully 9 delineate, I will designate an hour of my questioning 10 of the witness, and they will counter-designate a 11 couple hours of my questioning of the witness. 12 dilutes the purpose, putting aside the cross. 13 Okay. That So it's a real slippery slope. And 14 if we're trying to parallel what happens in the real 15 world, you know, number one, they should be really 16 limited in designating questions that I ask, only to 17 contextual questions. 18 But limit the cross as well. So I wanted to be clear about what 19 ultimately happens in the real world when we're dealing 20 with these things. 21 22 23 It's not so much Mr. Hewes' cross. THE COURT: You're saying this trial is not in the real world? MR. TISI: No, I'm saying in the real world 24 where we call live witnesses. 25 malpractice -- if I'm calling a doctor in a malpractice Golkow Technologies, Inc. If I'm calling a Page 35 August 31, 2015 1 case, I may call him for a half hour. 2 ask the eight hours of questions. 3 THE COURT: I'm not going to Again, I think we've all been 4 around long enough to know, the person who calls the 5 witness sets the scope by the questions that are asked. 6 And then I have to look at what's being proffered in 7 response to that, and I have to say, okay, or I say, 8 "That's interesting, but it's part of your case; it 9 doesn't come up now. 10 You're going to have to simply, you know, hold that video until it's your turn." 11 MR. MILLING: 12 THE COURT: 13 MR. MILLING: I think that's fair. I don't know how else to do it. I think all Chris was saying 14 is that we don't think the defense should be able to 15 play -- to stuff the turkey and play my questions or 16 Chris's questions as part of their evidence. 17 THE COURT: I'm not going to say that some 18 of your questions are out of bounds. 19 say that. 20 I'm not going to I mean, I'm going to look at -- and let's 21 hear Mr. Hewes' response to this. 22 stuffing the turkey. 23 other things, not for this. 24 I'm going to look at efforts to stuff -- and I know 25 you've never tried to do that. Golkow Technologies, Inc. I'm going to look at I've heard that phrase used for It's pretty interesting. Page 36 August 31, 2015 1 I'm going to look at efforts to stuff the 2 turkey with a pretty, you know, green-shade eye. 3 going to scrutinize them very carefully, saying, 4 "Mr. Hewes, you're a pretty bright guy. 5 hear your questions to Dr. Temple? 6 more of Mr. Tisi? 7 we hearing more from you?" 8 9 I'm Why don't we Why are we hearing I heard enough of him. Why aren't So the scope of what he's doing has got to be limited by the scope of what you're doing. 10 MR. HEWES: Your Honor, I believe that the 11 questions that we designated that they asked were 12 completeness-type questions. 13 Not to use another food analogy, but the proof will be 14 in the pudding, Your Honor, when we get there. And that will come out. 15 THE COURT: I agree. 16 MR. HEWES: And I had the opportunity to 17 spend many days with Mr. Tisi and Mr. Milling all over 18 the country. 19 asked any question to say, "Do you recall the question 20 Mr. Tisi asked you?" 21 And I made a concerted effort before I And then I discussed that. We'll see it. We'll play it. We're kind 22 of putting the cart before the horse, but they will be 23 contextual. 24 Your Honor, in terms of our designations. 25 And I think we're saying the same thing, THE COURT: Golkow Technologies, Inc. And I recognize that, and I Page 37 August 31, 2015 1 don't view this as freedom, but, yeah, I have a great 2 degree of discretion and I view that as serious 3 responsibility. 4 And what I know that you're sensitive to, 5 and I'm very sensitive to, is whether you call it the 6 reader's eye, juror's eye, the juror's ear, I'm very 7 sensitive to that. 8 presentations to be unnecessarily distracted. 9 I don't want the audience for the I want the stories that each one of you 10 need to tell -- I want them to be as coherent and as 11 seamless as each side permits it to be, because then I 12 know that the jurors have got competing stories and 13 they are going to make sense of it, provided, you know, 14 we don't overwhelm them, I don't give them a stupid 15 charge, somebody doesn't do something crazy during the 16 case. 17 You know, my hope is that each one of you 18 makes the best presentation you can make, that the 19 jurors are as informed as possible, and that they 20 render a fair verdict. 21 So I will make my decisions on the tapes 22 that are played. 23 trials, but it sounds like we're going to have a hell 24 of a lot of tapes. 25 I mean, I've had lots of tapes in MR. MILLING: Golkow Technologies, Inc. And that's the nature -- for Page 38 August 31, 2015 1 example, Dr. Kuffner lives in Switzerland. 2 know, given the breadth of this litigation, all of the 3 depositions are for use in this case as well as for use 4 in the MDL. 5 THE COURT: As you We're going to be in a 6 different courtroom, and I'm sure you've done this 7 before, but I just want to make sure that the screen 8 and everything is -- because what we don't want to do 9 is spend a heck of a lot of time fiddling with the 10 11 12 13 presentation. MR. HORN: We'll work together on this. We'll make sure it works. THE COURT: It's going to be 14 Judge Marczyk's courtroom we're going to be using, and 15 I know it's fully equipped. 16 your IT people use it as efficiently as possible so we 17 don't have jurors waiting 15, 20 minutes between clips. 18 MR. MILLING: You just have to make sure Both of us have used the same 19 service throughout the case. 20 same service throughout the trial. 21 folks that have experience doing this where the 22 witnesses will come up, the documents will come up that 23 they are talking about, all of that kind of stuff. I suspect we'll use the And these were 24 THE COURT: 25 But how many witnesses do you think will be Golkow Technologies, Inc. I've seen you do it before. Page 39 August 31, 2015 1 called by video? 2 MR. MILLING: We're going -- we're working 3 on our order of proof right now -- a substantial 4 number. 5 I will tell you that one of the things that 6 I will raise at the end, that we can talk about at the 7 end, I do think, given the fact that the Jackson case 8 has been selected for trial and the only issue in that 9 case is design defect, that the plaintiff -- I know 10 when we submitted our cuts back at the beginning of 11 July, our proposals, which I don't think we've gotten a 12 response to -- we did? 13 We just got them on Friday. And we may need to tweak them, in fairness, 14 given the fact that the case is now proceeding only on 15 one cause of action. 16 want to take up at the end. 17 that we need to add in because we were going to try the 18 case one way with more of a warnings focus, and now 19 there's no warnings focus, and a lot of that evidence 20 is not even going to be part of the case. I just raise that as something we There may be other stuff 21 The issue is, was the product defective at 22 the time it was on the shelf when the plaintiff bought 23 it. 24 25 THE COURT: Okay. The motion is granted, subject to my review of the clips and guided by the Golkow Technologies, Inc. Page 40 August 31, 2015 1 principles of fairness and completeness. 2 MR. MILLING: 3 THE COURT: 4 Thank you, Your Honor. That's all I can do at this point. 5 Next, exclude evidence or argument that 6 defendants were precluded from changing the label 7 without FDA approval. 8 9 Again, we've got the role of the FDA. We certainly know there's a long history of exchanges 10 between McNeil and FDA. 11 to get into some of those exchanges. 12 MR. MILLING: And I don't doubt we're going The issue here is precluded. 13 I don't think that under the monograph system and under 14 314.70, which is changes being effected -- I think 15 we've all come to see the testimony, even from 16 Dr. Temple, from changes being effected, 21 CFR 314.70, 17 the monograph system -- Your Honor's order that 18 defendants can freely change under a tentative filed 19 monograph. 20 suggest to the jury that they were precluded from 21 changing the label. 22 23 24 25 And so it would be actually improper to They can -- they can change the label under most systems. MR. KOTT: Let me clear one thing up. Changes being effected only applies to prescription Golkow Technologies, Inc. Page 41 August 31, 2015 1 medicine. 2 MR. MILLING: 3 MR. KOTT: 4 MR. MILLING: You used changes being effected in 1990 court filings -- 7 8 That's my understanding, but that's okay. 5 6 That's not true. THE COURT: Why don't you let him finish. He didn't interrupt you. 9 MR. KOTT: It was -- at one point, Your 10 Honor will recall that McNeil went through the NDA, new 11 drug -- 12 13 THE COURT: Correct. And then they withdrew it. 14 MR. KOTT: 15 And CBE, changes being effected, would And then they withdrew it. 16 apply to the NDA, but this case isn't about a 17 prescription drug. 18 Second thing -- and I think even 19 Mr. Milling acknowledges in one of the colloquies, the 20 day we had the blow-ups of the labels -- we cannot 21 change the organ-specific warning because of the 2009 22 rule published in the Code of Federal Regulations. 23 So there are parts of the warnings by law 24 we can't change. 25 law to change the organ-specific. It would be a violation of federal Golkow Technologies, Inc. And I'm referring to Page 42 August 31, 2015 1 the liver warnings. 2 about. 3 Your Honor knows what I'm talking So I think the -- we think the Court needs 4 to kind of slice this a little and talk about what 5 we're talking about, because, for some of it, we might 6 have some ability to change the warnings without FDA 7 approval. 8 the law if we did. But some of it we would be in violation of 9 MR. MILLING: Your Honor, let me just back 10 up. 11 all, even -- first of all, I joked with my wife that 12 you told Mr. Tisi, she knows Mr. Tisi, that he 13 interrupts himself. Changes being effected applies to NDA. 14 First of I just interrupted myself. Under the monograph system, the company is 15 free to change their label, their warnings, and 16 voluntarily. This drug marketed under -- 17 THE COURT: 18 MR. MILLING: 19 THE COURT: 20 21 Any aspect? Any aspect. I didn't understand it that way. MR. MILLING: As it relates to the final 22 warning, what Mr. Kott just said was improper. 23 Regulatorily, respectfully. 24 25 Wrong. If there is a final rule, that's the floor, not the ceiling. And as I showed Your Honor, 21 CFR Golkow Technologies, Inc. Page 43 August 31, 2015 1 Section 311 specifically provides for an NDA deviation 2 if the company wants to ask the FDA to change the 3 label. That's number one. 4 As to changes being effected, even after 5 Extra Strength Tylenol moved to the monograph system -- 6 and Your Honor may remember the document, may not. 7 I'll represent to the Court that in 2004, even after 8 Extra Strength Tylenol moved to the monograph system, 9 McNeil at all times has an NDA filed that's called 10 But extended-release product; it's in Tylenol. 11 In 2004, they wrote to the document, and 12 they said, under the CBE 314.70, we're going to change 13 our label to put a liver warning on extended-release 14 Tylenol in the NDA, and then we're just going to make 15 all our monograph products consistent. 16 they did. 17 always says, "We voluntarily put a liver warning on it 18 to get overdose warning in 2004." 19 that was by sending as changes being effected to their 20 NDA product and announcing to the government, "We're 21 going to put it on our monograph." 22 That's what And that's when Mr. Hewes stands up and The way they did The bottom line is, we have talked about 23 this ad nauseam. 24 the label, and to suggest or infer to the jury that 25 they can't voluntarily do it is wrong regulatorily and There is no preclusion from changing Golkow Technologies, Inc. Page 44 August 31, 2015 1 would be wrong for the jury to even have that idea 2 floating in their head as a possibility. 3 The jury may hear in this case multiple 4 times where McNeil has voluntarily changed their -- 5 that they voluntarily put on an alcohol warning. 6 they even sent out press releases saying we have 7 voluntarily done this and we urge the entire industry 8 to do it. 9 And They voluntarily put on a liver warning in 10 2004. 11 three, which Your Honor in the order last week noted 12 they did voluntarily and they are free to do. They voluntarily reduced the dose from four to 13 To suggest to this jury that they are 14 precluded from doing that is all we're saying that you 15 can't do. 16 not the way the system works. Almost -- it's brought on the jury. That's 17 MR. HEWES: May I address this, Your Honor? 18 THE COURT: Go ahead. 19 MR. HEWES: They are both apples and 20 oranges in the bucket that Mr. Milling is arguing from, 21 and he's continually improperly comparing the two. 22 Let's be perfectly clear here. We're not 23 talking about the Taylor case right now as I understand 24 it. 25 dispute as to the label in the Jackson case as to We're talking about the Jackson case. Golkow Technologies, Inc. There's no Page 45 August 31, 2015 1 whether it was a post, final, ruled label. 2 doubt that acetaminophen and other antipyretics are 3 still under a tentative filing monograph to some 4 extent. 5 There's no If Your Honor recalls, in 2009, with the 6 issuance of the final rule, those portions of the final 7 rule and the tentative final monograph have been deemed 8 final. 9 monograph. That portion of the labeling is a final I can pull out the regulation and show it 10 to you. 11 more. 12 must put in your label as it relates to liver damage." 13 But it doesn't say this is a floor, you can do It says, "This is the mandatory language you Upon the issuance of the final rule, Your 14 Honor, that laid out what was to happen and what the 15 companies were to put in the label. 16 Could we have changed the label after that? 17 Mr. Milling actually cited the wrong regulation. 18 said 21 CFR 311. 19 He It's actually 21 CFR 330.11. The FDA says, "If you want to change it, 20 you have to file a new drug application." 21 Honor remembers the new drug application process, it is 22 a lengthy, detailed process. 23 in 21 CFR 314.50. 24 you have to do a new drug application. 25 If Your In fact, it's enumerated The FDA gives 10, 20 pages of how So can McNeil change the label voluntarily Golkow Technologies, Inc. Page 46 August 31, 2015 1 after the final rule? 2 to go through a new drug application process and get a 3 new drug approved with that label post final rule. 4 It's 21 CFR 330.11. 5 there's no confusion, because I'm seeing some popping 6 up over there. 7 Absolutely not. We would have And I'll read it to Your Honor so It says, "A new drug application requesting 8 approval of an OTC drug," which we have here, 9 "deviating in any respect from a monograph that has 10 become final," what we have here as to the language in 11 the final rule, "shall be in the form required by 12 Section 314.50." 13 Section 314.50 is the regulations for 14 submitting a new drug application. 15 everything in the new drug application. 16 include a statement that the product meets all 17 conditions of the applicable monograph except for the 18 deviation for which approval is requested." 19 20 21 It doesn't require It says "shall So it requires express explicit FDA approval. There can be no question about that. Prior to the implementation of the final 22 rule, McNeil did make changes to the label, and one of 23 the methods was through the NDA process to do a change 24 as being effected per 21 CFR 314.7. 25 Even under the CBE process, Your Honor, the Golkow Technologies, Inc. Page 47 August 31, 2015 1 FDA has 30 days to bless it or not bless it before it 2 can go into effect. 3 In every instance, as we've shown Your 4 Honor in our prior presentations, there is a letter or 5 a record of correspondence from the FDA prior to the 6 issuance of the final rule where the FDA said, "We will 7 allow you to do this," or, "We will not allow you to do 8 this." 9 And we have to get FDA enforcement 10 discretion to change the label prefinal ruling. 11 of course, the discretion simply means the FDA won't 12 pop us if we go ahead and change the label. 13 And, What we're talking about in Jackson, we're 14 talking about a post-final-rule process here. 15 only way to change it per the regulations is to file a 16 totally new NDA. And that's being lost in the 17 discussion here. And I want to make sure that's out 18 there, because that's what the regulations require. 19 20 21 THE COURT: And the What was the process by which McNeil went from 4 to 3 grams? MR. HEWES: From 4 to 3 grams, they 22 processed post that -- or the FDA in 2000, or shortly 23 after that, the FDA said, "There's some confusion in 24 the post-final-rule area." 25 some allowance," and they will exercise enforcement Golkow Technologies, Inc. And they said, "There's Page 48 August 31, 2015 1 discretion to allow some deviation in the actual dosage 2 that's allowed to be put on the label. 3 And you'll notice in the label, Your Honor, 4 even in the label it ultimately says, "Don't take more 5 than 3 grams, but 4 grams has been recognized as the 6 maximum recommended dosage." 7 discussion as to the dosage, but there was no post 8 discussion as to the final rule liver damage -- 9 THE COURT: There was some post When the label went from four 10 to three, did McNeil do anything other than write a 11 letter? 12 MR. HEWES: McNeil went to the FDA. 13 discussed it with the FDA. 14 to -- 15 THE COURT: McNeil McNeil received approval But what was -- what was the 16 blessing from FDA, other than saying, "We got your 17 letter"? 18 MR. HEWES: The FDA says it's allowable and 19 approvable. 20 like to see it, Your Honor. 21 22 23 24 25 And I can pull the letter up if you would THE COURT: McNeil wrote a letter, and FDA MR. HEWES: McNeil went to the FDA. said okay? McNeil worked with the FDA. THE COURT: Golkow Technologies, Inc. That doesn't sound too arduous Page 49 August 31, 2015 1 to me. 2 3 MR. HEWES: It was a process that was gone through, Your Honor. 4 THE COURT: 5 it right at the start. 6 thin, because generally I think there are changes that 7 McNeil can make, and then there's going to be those 8 that they can't. 9 this issue. 10 I'm going to have to slice this So we're going to have to revisit But for now, what I'll do is simply deny it 11 without prejudice. 12 me to approach this. 13 revisit this issue. 14 I think Mr. Kott may have said I think that's the safest way for But we're going to obviously Exclude any mention that compliance with 15 FDA regulation absolves liability. 16 that FDA designation means something, right? 17 approval means something. 18 MR. MILLING: Well, we do know FDA It's not insignificant. It does, but compliance with 19 legislative enactment, administrative regulation or 20 safety codes, because while evidentiary, is not 21 conclusive as to the non-negligence of a manufacturer 22 in the State of New Jersey -- 23 THE COURT: 24 MR. MILLING: 25 I agree. -- and compliance, and so there should be no inference. Golkow Technologies, Inc. Whether we're trying a Page 50 August 31, 2015 1 pharmaceutical case or a trucking case or an automobile 2 case, compliance with the federal regulation does not 3 absolve a defendant of liability under state court law, 4 and certainly -- 5 THE COURT: But there is a process by which 6 this drug ultimately made its way onto the market. 7 it's a long process with -- loaded with history. 8 we're talking about a product that's been on the market 9 for 50 years and is widely used. 10 11 12 And And And throughout that process, FDA was giving various blessings. MR. MILLING: Your Honor, to be clear, this product was grandfathered under the market. 13 THE COURT: 14 MR. MILLING: 15 THE COURT: I know. So actually -As I said before, they didn't 16 invent acetaminophen. 17 They were able to develop a portion of the market on 18 the delivery of this particular product. 19 They don't have a patent on it. MR. MILLING: As Your Honor knows very 20 well, this product is now governed -- except for that 21 one liver warning, which is that one box, it's governed 22 under a tentative final monograph, which has the force 23 of law of a proposed rule and nothing more. 24 25 And the defendant -- and as we saw, and Your Honor quoted, they are free to make changes. Golkow Technologies, Inc. And Page 51 August 31, 2015 1 so to suggest -- 2 3 THE COURT: Well, they are not absolved of liability. 4 MR. MILLING: 5 THE COURT: Perfect. Okay. We understand that, and 6 the jury is going to understand it. 7 approvals that they need to market this product from 8 FDA? But do they have Yeah, they do. 9 MR. MILLING: Actually, they don't have 10 approval. 11 market at their own risk. 12 The FDA, as it relates to tentative final monographs, 13 has decided not to take enforcement action against it. 14 There has been no formal approval. 15 THE COURT: Under the tentative final monograph, they It's actually the reverse. Well, I think the history tells 16 you otherwise. 17 get into that discussion, I guess, in a little bit when 18 we talk about GRASE, or GRASE, however you're supposed 19 to say it. 20 21 We're not going to have that -- we'll MR. HEWES: grandfathered. 22 Extra Strength was not It was approved in 1975. THE COURT: Correct. 24 MR. HEWES: There was a misstatement. 25 MR. HORN: 23 I've got it right here. Golkow Technologies, Inc. Just very briefly, Your Honor, I Page 52 August 31, 2015 1 think you just touched on it, and we dealt with this in 2 the Vioxx trials years ago. 3 here, as I understand there's a good chance they're 4 going to be arguing, there's an FDA -- there's an 5 approval process. I think one of the nuances We did what we're supposed to do. 6 The issue here is it's not taking away the 7 province of the jury, and that's why part of the words 8 of our warning was to say "precludes liability." 9 is the argument that we want to preclude. That I'm sure 10 we'll be able to deal with this, Your Honor, at the 11 trial, and be able to say to the jurors, essentially 12 you can't find against us, because the FDA said we play 13 by the rules. 14 referred to the FDA as the cops. 15 In that case, the defense counsel THE COURT: They're not going to hear from 16 me that they can't find for the plaintiffs because of 17 the FDA. 18 MR. HORN: Or from counsel. Just to give 19 Your Honor an example, in that case, the defense 20 counsel referred to the FDA as the cops, literally, and 21 said, "The cops said we did it okay." 22 our argument was, they took away the province of the 23 jury by saying you can't find for us because the FDA 24 did. 25 This whole theme was throughout the trial. They're the scientific jury. Golkow Technologies, Inc. And essentially They're the cops. And that's Page 53 August 31, 2015 1 what we're concerned about. 2 THE COURT: Just as I permit broad 3 cross-examination, I also permit a lot of freedom in 4 remarks that you make directly to the jurors whether in 5 your opening or your closing. 6 judge of whether or not your remarks stand up in light 7 of the facts. 8 9 MR. HORN: They're going to be the That's good to know, Judge, because it's always more fun to try cases that way. 10 But this is a specific area. 11 just the jurors should not be disempowered that they 12 can't come to a verdict because there's some sort of 13 shield, some sort of immunity. 14 THE COURT: I think our concern is We're going to have a 15 discussion, obviously at the end of the case, not only 16 on the charge, but also an idea of where people think 17 they are going to go with their closings. 18 And if they go some place -- I really don't 19 like commenting on closing arguments. 20 commenting on closing arguments. 21 it. 22 that I'm commenting on. 23 I hate Very rarely do I do If I have to, it doesn't work well for the party So I hope we don't hear something like FDA 24 is the cops, you know, because their role is a little 25 bit different than that. Golkow Technologies, Inc. But it's an important role Page 54 August 31, 2015 1 too. 2 been set up better? 3 system is what it is because of the society that we 4 have and because of the political culture that exists. 5 It is what it is. 6 It's an important -- look, could the system have Probably. But I also think the And that's one of the reasons the Supreme 7 Court said, you know, the FDA ain't final. 8 a role here too. 9 States have So in terms of -- the motion is granted 10 with the understanding that we have a lot more 11 conversation on FDA. 12 Exclude any mention that manufacturers do 13 not have the ultimate responsibility for providing 14 adequate warnings. 15 You do have the ultimate responsibility. 16 product going onto the market. 17 Why wouldn't I grant that, defense? MR. KOTT: It's your I think I agree with the Court, 18 except for -- and, again, the FDA is all over this 19 case. 20 THE COURT: 21 MR. KOTT: It is. We should be allowed to say 22 through witnesses and/or in argument that the FDA has 23 the final authority over all this. 24 25 Part of the problem with the plaintiffs' motions is, you know -- and the last one is an Golkow Technologies, Inc. Page 55 August 31, 2015 1 example -- well, they shouldn't be allowed to say that 2 we can never be held liable because we met the FDA 3 regulations. 4 But that doesn't mean that we can't point 5 out to the jury that we -- evidence of meeting 6 regulations is -- 7 8 THE COURT: is evidential. 9 10 MR. KOTT: Jersey. 11 12 Evidence of meeting regulations Both for Oklahoma and New So the way these are -THE COURT: Evidence of violating a regulation is evidential too. 13 MR. KOTT: So if the Court were to say -- 14 granted, my concern would be, what exactly on many of 15 these motions is the Court granting? 16 sure, under New Jersey product liability law, we have 17 the responsibility for design and warnings, same thing 18 under Oklahoma. 19 Because, again, If that weren't the case, you would throw 20 the case out or somebody else would. 21 authority, I don't think there's anything wrong with 22 our witnesses or counsel saying that or counsel arguing 23 that. 24 25 THE COURT: Again, on some of these, I'm saying denied without prejudice. Golkow Technologies, Inc. But on final And it's a peculiar Page 56 August 31, 2015 1 way to say granted without prejudice. 2 my hand to one side or the other to say going forward, 3 you know, you're going to have a heavy burden of 4 persuasion to convince me otherwise. 5 can do here. 6 MR. MILLING: And I'm tipping And that's all I It's more inferential. 7 is directly from Wyeth versus Levine. 8 has the ultimate responsibility -- 9 THE COURT: 10 MR. MILLING: -- the ultimate responsibility for their labeling. 12 THE COURT: 13 MR. TISI: Thomas wrote that, right? I believe it was Justice Stephens, but I don't recall. 15 MR. KOTT: 16 THE COURT: Pardon me. 17 MR. KOTT: May I amend? 18 The manufacturer Clarence Thomas' revenge. 11 14 This Thomas wrote the generic. That was Justice Thomas. 19 THE COURT: 20 MR. MILLING: Justice Thomas. So this motion's just Wyeth 21 versus Levine. 22 anybody other than the manufacturer has an ultimate 23 responsibility for what's on the label. 24 law. 25 You can't imply to the jury that THE COURT: Golkow Technologies, Inc. That is the Again, I said I agree with you. Page 57 August 31, 2015 1 But, again, granted, you know, without prejudice, 2 meaning they've got the burden to convince me 3 otherwise. And the other one was denied without 4 prejudice. It's unusual to say granted without 5 prejudice, but you know what I'm getting at. 6 Next, exclude any mention of nonliability 7 because Tylenol was approved by the FDA. 8 sort of thing. 9 10 11 12 13 Again, same Granted without prejudice. Exclude any argument that Tylenol is GRASE. Do you want to argue that again? MR. MILLING: No, sir. You're welcome to. We incorporate our prior argument. I would say that, and it shouldn't be a -- 14 especially in the Jackson case, we're going to be 15 talking about product defect. 16 Tylenol is used by millions of people, certainly. 17 the truth of the matter is, there has been no final 18 monograph on Tylenol and on acetaminophen; and the FDA 19 has said, in the 2009 Federal Register, we still have 20 many questions regarding acetaminophen. 21 question they list is, we're still, at the FDA, 22 concerned about the maximum safe dose. 23 THE COURT: What we don't want -But And the first I understand that, but -- and 24 I'm going -- for purposes of this record -- and I'll 25 ask Mr. Kott to put it in the order too. Golkow Technologies, Inc. My decision Page 58 August 31, 2015 1 of August 28, 2014, was arrived at after a really -- 2 you know, look, I'm still the new kid on the block 3 here, but still a very painstaking review, when I go 4 back and look at FDA's correspondence of May 15, 5 1975 -- and correct me if I have the dates wrong -- and 6 July 22, 1975, where they conclude both letters with 7 this sentence: 8 application and have concluded that the drug is safe 9 and effective for use as recommended in the submitted 10 "We have completed the review of this labeling." 11 Nothing that ever happened after that 12 eliminated those words "safe and effective." 13 And you can argue all you want. 14 have to show me in the history where they did. 15 they didn't. 16 17 MR. MILLING: Nothing. But you're going to Again, here we go. And The trap has been set, respectfully. 18 In 1975, those letters were written to 19 Tylenol saying Extra Strength Tylenol as a product, 20 which was asking to be approved under an NDA. 21 NDA has nothing to do -- does not do GRASE. 22 THE COURT: Yeah, but they made a finding 23 on acetaminophen, which is, generally it's safe and 24 effective. 25 MR. MILLING: Golkow Technologies, Inc. No, no. Actually, that's not Page 59 August 31, 2015 1 what NDA does. 2 Extra Strength Tylenol with a certain label for 3 prescription -- and that is what they found in 1975 -- 4 with this label which said -- 5 NDA, respectfully, made a finding on THE COURT: We're talking about the 6 evolution of a label. 7 talking about the evolution of a label. 8 about their finding with regards to a particular 9 chemical compound. 10 We're not talking -- you're MR. MILLING: I'm talking But they did not find it to 11 be GRASE, because GRASE is only found in the monograph 12 system. 13 NDA doesn't find grace. THE COURT: I'm not -- I don't have enough 14 authority to tell the FDA that their sentence that they 15 repeated twice in two letters, where they said "safe 16 and effective" -- I don't have the authority to tell 17 them, "You know, you got it wrong." 18 MR. MILLING: I'm not saying that. I'm 19 just respectfully saying that the issue is that there's 20 a regulatory finding that is not just "safe and 21 effective," which is called "generally recognized as 22 safe and effective and not misbranded," and it doesn't 23 apply to products like Extra Strength Tylenol. 24 applies to ingredients -- 25 THE COURT: Golkow Technologies, Inc. It The problem I get into is when Page 60 August 31, 2015 1 they create the categories of medications too. 2 this is a Category 1 analgesic and a Category 1 -- 3 however you say that word -- antipyretic. 4 MR. MILLING: And It is never -- as you said, 5 the Code of Federal Regulations is the law. 6 Federal Register is not. 7 the FDA in the Code of Federal Regulations that 8 acetaminophen is a Category 1. 9 10 It has never been stated by THE COURT: Category 1. 11 The It's been proposed -- I recall reading it. It's in Acetaminophen is a Category 1 medication. MR. MILLING: It has been proposed by the 12 advisors in 1977 and accepted tentatively in 1989, but 13 not in the CFR. 14 THE COURT: Okay. Here is the thing, 15 though. 16 that this is -- that this acetaminophen is generally 17 regarded as safe and effective, I'm going to find that 18 argument to be acceptable. If one of their witnesses or the lawyers argue 19 MR. MILLING: 20 THE COURT: 21 Exclude evidence of personal use of Tylenol That's fine. So that motion is denied. 22 by any party, witness, or counsel. 23 consent to that being granted? 24 25 MR. KOTT: You're going to I'm looking to my right, Your Honor. Golkow Technologies, Inc. Page 61 August 31, 2015 1 MR. MAYES: Yeah. The only case that I 2 think it's been made, fair mentioning, is in the Taylor 3 case because of what happened to the Tylenol that 4 Mrs. Taylor ingested. 5 ingested after her death, went to her sister, who 6 consumed it, along with her roommate. 7 may be relevant. The specific bottle that she In my mind, that 8 If the daughter is aware at the time of her 9 mother's passing that Tylenol may have had something to 10 do with her illness and then goes on to consume the 11 entire bottle over the course of the next 12 months, I 12 think it goes to her credibility if she takes the stand 13 to suggest that somehow it's not safe. 14 THE COURT: Well, that very narrow 15 situation is something I want to hear plaintiffs' reply 16 to. 17 MR. HORN: It's slightly different than 18 what I thought we would be arguing in the motion, Your 19 Honor. 20 Specifically, to begin with, in terms of if 21 any of its employees -- we hope that's a nonissue with 22 the Court. 23 don't know the fact that Mr. Mayes didn't address it 24 means they agree to that as well. 25 even bother. It's our position that that would be -- I Golkow Technologies, Inc. If yes, then I won't Page 62 August 31, 2015 1 But it's our argument that any defendants' 2 employees getting up there and saying, "We take 3 Tylenol; we think it's safe," should absolutely be 4 precluded. Same with expert witnesses -- 5 THE COURT: 6 MR. HORN: 7 THE COURT: It's not going to happen. Okay. I'm not going to have a lawyer 8 stand up in opening argument or a witness take the 9 stand and say, "I take Tylenol every day. 10 taking it for 30 years. 11 it every day." MR. HORN: 13 witnesses, counsel -- 15 I've got a bad knee, and I use No, that's not going to happen. 12 14 I've been THE COURT: Okay. Same with expert What about Mr. Mayes' situation where -- is it the daughter or the sister? 16 MR. MAYES: Daughter. 17 THE COURT: The daughter is going to say, 18 "I think Tylenol killed my mom," yet she kept taking 19 Tylenol herself afterwards. 20 MR. HORN: This is a very narrow situation, 21 Your Honor. 22 it's a completely different situation. 23 just irrelevant. 24 expert opinion that "I think Tylenol is a bad drug, 25 because I am a toxicologist or I'm a chemist" or But our argument is that, first of all, I mean, it's I mean, she's not giving a scientific Golkow Technologies, Inc. Page 63 August 31, 2015 1 whatever. 2 3 She is -- if this happens, she'd be a family member saying -- 4 THE COURT: It's going to depend upon what 5 that witness says on direct examination. 6 witness starts crying about, you know, this lethal 7 over-the-counter drug that her mom took -- If the 8 MR. HORN: 9 THE COURT -- and her mom was unaware of how 10 Fair enough. unsafe it was -- 11 MR. HORN: 12 THE COURT -- and she kept on taking it 13 I'm sure. herself, that might affect her credibility. 14 MR. HORN: If the daughter was to say, I 15 think Tylenol caused this because one of the doctors at 16 the hospital said it, or because I found out afterwards 17 because I looked on the computer, or I don't know, 18 whatever, the fact that she then chose to take it is 19 her business. 20 situations, maybe she took it much less. 21 took it only in certain situations. 22 had a hangover one night and took a pill. 23 that's -- 24 25 And maybe because it's under different THE COURT: Maybe she Maybe because she That's -- I'm granting your motion. I'm granting your motion with the understanding that, with Golkow Technologies, Inc. Page 64 August 31, 2015 1 the narrow incident that Mr. Mayes gets to, we're going 2 to have a discussion. 3 4 Before he cross-examines a witness, we're going to have a discussion. 5 6 MR. HORN: Fair enough, Your Honor. We won't open the door, so it's not an issue. 7 8 Okay. THE COURT: And, again, if you open the door, he may get -- be permitted to walk through it. 9 MR. TISI: I do have one point of 10 clarification in this regard, as I understand this 11 motion, personal use and vouching for the drug by 12 corporate witnesses and that kind of thing. 13 What is relevant in this case -- and I 14 referred to it last week when we were talking about, 15 for example, all the DILI experts, you know, the 16 hepatologist -- to a person, to my knowledge, whether 17 it's Dr. Flann, Dr. Brown, Dr. Cohen in the Lyles case, 18 Dr. Kaplowicz, Dr. -- all these doctors have said very 19 clearly on the record that they prescribe for their 20 patients less than four grams. 21 them. 22 precluded from establishing that -- I want to be clear that we're not going to be 23 24 25 Every single one of THE COURT: And I recall reading all of that, and -MR. TISI: Golkow Technologies, Inc. That's different. Page 65 August 31, 2015 1 THE COURT: -- how I took it is they're 2 erring on the side of caution. 3 professionals do, don't they? 4 MR. TISI: Right. Like a lot of But that's different -- 5 you know, I want to make clear that this ruling is not 6 broadened to preclude us from cross-examining, for 7 example, if Dr. Flann were on the stand in the Taylor 8 case and saying, look, you increase the margin of 9 safety for your patients because you -- and you 10 11 12 13 understand that they may take more of a direct -THE COURT: preclude you. The answer is, no, it doesn't That's fair cross-examination. MR. MAYES: Briefly, two points. On the 14 experts' testimony that they often recommend less than 15 four grams to their patients, keep in mind that all of 16 these doctors are dealing with patients that have liver 17 disease already. 18 So that's an important distinction. The second thing I want to mention as it 19 relates to personal use of Tylenol is there are design 20 defect claims in both cases. 21 there will be expert witnesses for the plaintiff taking 22 the stand and testifying that Tylenol is defectively 23 designed and unreasonably unsafe. 24 25 So we can expect that And I'm not so sure that there's not a pretty good argument that they -- we ask them if they Golkow Technologies, Inc. Page 66 August 31, 2015 1 take Tylenol personally and they say yes, then that 2 goes to their credibility as well. 3 that I think we might want to discuss. 4 THE COURT: That was one issue I'm not going to have a witness 5 vouching for Tylenol's safety by saying, "I take it all 6 the time." 7 questioned concerning how they prescribe it. 8 Mr. Mayes said if somebody -- if somebody was careless 9 enough to say, "I think Tylenol is lethal," and they I am going to permit witnesses to be And 10 are taking it themselves, that might be interesting 11 testimony. 12 MR. MILLING: Your Honor, I think what you 13 said is fair. 14 have an opportunity before those questions are asked to 15 explore with the witness. 16 nobody in this case is going to say that taking two 17 Tylenol for a headache puts you at risk for DILI. 18 What we would only ask for is that we As the Court is well aware, So the question is, would a witness take 19 this chronically at the maximum recommended dose or 20 thereabouts. 21 would be relevant. 22 would be prejudicial, because it would imply that they 23 are vouching for the drug, they believe the drug is 24 safe. We're only -- there's only one defect in the 25 case. That's the margin of safety and how it applies And that would be the only time that it Golkow Technologies, Inc. Taking two Tylenol for a headache Page 67 August 31, 2015 1 2 to people. THE COURT: I'm granting your motion. 3 Again, if we get a situation where the defense says on 4 cross-examination, "Look, they raised this issue; we 5 want to go after it," we'll have that conversation. 6 MR. MILLING: 7 THE COURT: Perfect. Let's talk about strike -- 8 Sherrie Cathcart, strike certain deposition testimony, 9 American Association For the Study of Liver Diseases, 10 11 witness Sherrie Cathcart. It seems to me, Mr. Kott, Mr. Mayes, or 12 Mr. Hewes, that the relief sought here is appropriate. 13 Tell me why it isn't. 14 MR. HEWES: Your Honor, you denied this 15 motion in the past, noting that you would let those 16 play out in a cross-examination in front of a jury. 17 18 19 THE COURT: I know I did. But the more I look at this, I'm saying this person is a layperson. MR. HEWES: Two things, Your Honor. If the 20 AASLD motion that we move to strike and our Motion in 21 Limine Number 16 based on hearsay is out, then we don't 22 need to address this, because the point is moot. 23 But Sherrie Cathcart was -- if the 24 documents are out there, no need to get there. 25 assuming we're there, Your Honor, Sherrie Cathcart was Golkow Technologies, Inc. But Page 68 August 31, 2015 1 the first witness taken in this litigation. 2 designated as a 30(b)(6) witness, not as plaintiffs 3 suggest, just to talk about this AASLD document. 4 She was She was designated on five topics, and I'm 5 going to just touch on them quickly. 6 designated to talk about testimony concerning the 7 AASLD, including its membership, mission, and 8 structure; the circumstances surrounding the initiation 9 and creation of the AASLD memorandum to the FDA, She was 10 including the authors and contributors responsible for 11 its content; and the process by which the memorandum 12 was approved by the AASLD; the conclusions and 13 recommendations made by the AASLD and its members. 14 And then this is an important one, Your 15 Honor: 16 policy committee to address the issue of acetaminophen 17 toxicity. 18 the efforts of the AASLD and the AASLD public No doubt that she was not a physician. 19 doubt that she was not a clinician. 20 designated -- No But she was 21 May I approach, Your Honor? 22 THE COURT: Sure. 23 MR. HEWES: -- to speak on behalf of the 24 AASLD. 25 this testimony should come in to put it in context. And if the AASLD document is in, Your Honor, Golkow Technologies, Inc. Page 69 August 31, 2015 1 And there is a reason why the plaintiffs don't want 2 this testimony in, Your Honor. 3 indicators as to why plaintiffs don't want this in, 4 because it does put the AASLD document in context. 5 And I flagged the main And it goes back to our argument why the 6 AASLD document shouldn't be in in the first place. 7 It's hearsay, set forth by a third party that was never 8 recommended or approved by the FDA. 9 What happened, Your Honor, in 2006, in the 10 Federal Register, the FDA was looking at different 11 acetaminophen risks and asked the industry and asked 12 groups such as the AASLD and asked stakeholders to 13 comment on the safety and effectiveness of 14 acetaminophen and other drugs. 15 ten topics for them to comment on. 16 17 And the FDA listed out The AASLD was one of many different institutions and entities that commented on these. 18 The FDA considered what the AASLD asked. 19 The FDA didn't adopt anything that the AASLD 20 recommended in the context of over-the-counter 21 medications. 22 In the 2009 Federal Register, the FDA 23 expressly said some of the submissions by the AASLD, 24 expressly as to whether there should be a 4-gram 25 notice, is not supported by any data. Golkow Technologies, Inc. Page 70 August 31, 2015 1 And if you look at the questions I asked 2 her, Your Honor -- and I want to touch on these, to put 3 it in context as to why the document is improper, and 4 if Your Honor thinks it's in, as to why her testimony 5 should come in. 6 "Question: You testified that the AASLD 7 works with and collaborates with the FDA on certain 8 projects, correct? 9 "Correct. 10 "And the AASLD recognized that the FDA is 11 the rulemaking authority for pharmaceutical 12 manufacturers, correct? 13 "Correct. 14 "And the FDA -- and the AASLD recognizes 15 that manufacturers are bound by the FDA's directives 16 regarding labeling and packaging of their products? 17 "Correct. 18 "And you agreed that the AASLD is not a 19 rulemaking authority, correct? 20 "Correct. 21 "And you are not critical or the AASLD is 22 not critical of a pharmaceutical company for following 23 the FDA's mandates and directives regarding labeling, 24 correct? 25 "Correct. Golkow Technologies, Inc. Page 71 August 31, 2015 1 "And the AASLD is not critical of a 2 pharmaceutical manufacturing company for following the 3 FDA's directive regarding packaging, correct? 4 "Correct." 5 And I also cited, Your Honor, if I can find 6 it, her conclusions. 7 212 and 216. Give me one second, Your Honor. 8 THE COURT: 211. 9 MR. HEWES: 211, Your Honor. 10 "What the AASLD did there is recommend that 11 the FDA consider the following specific directions or 12 warnings for acetaminophen, correct? 13 "Correct. 14 "And the AASLD in italics listed a series 15 of bullet points that the AASLD proposed to be a label 16 for Tylenol, correct? 17 "Correct. 18 "And it asked the FDA to consider this and 19 to adopt this label? 20 "Correct. 21 "Question: 22 Is that correct? And the FDA did not adopt the AASLD label, did it? 23 "Correct." 24 That is in the context of what she was 25 designated to be deposed for. Golkow Technologies, Inc. That directly addresses Page 72 August 31, 2015 1 the AASLD document. 2 has been waved around like gospel since day one. 3 been used at every deposition. 4 every hearing. 5 brief as to what the pharmaceutical manufacturers 6 should have had notice of and what the pharmaceutical 7 manufacturers should use -- should have used as a 8 guide. 9 This AASLD document, Your Honor, It's It's been cited at And it's been listed in almost every And the questions I asked her relate to 10 those five topics. 11 there was a question as to why Will Lee, who was the 12 author of that AASLD document, wrote Sherrie Cathcart 13 and said, "I don't want my name on it." 14 her some questions about that. 15 later questions about some AASLD scientific documents 16 that were authored by Will Lee and asked about the 17 validity of those. 18 Now, admittedly, towards the end, So I did ask And I asked her some And I believe, if Your Honor recalls, when 19 we were going through the deposition designations, we 20 pulled some of that and realized it's probably not 21 proper to ask her some scientific opinions. 22 But these opinions, the bulk what I asked 23 her, are facts, and they're facts that the executive 24 director of the AASLD knows about. 25 She knows about interactions with the FDA. Golkow Technologies, Inc. Page 73 August 31, 2015 1 Everything I asked her that we designate, Your Honor, 2 goes to those four topics. 3 topic said interaction between the FDA and the AASLD -- 4 interaction between the FDA and the AASLD as it relates 5 to this document, and the AASLD's position on 6 acetaminophen hepatotoxicity. 7 And let's not forget the That's what she was designated for. 8 what I asked her about. 9 document should come in anyway. That's We don't think the AASLD And I've some basis 10 for that later. 11 was proper cross-examination to ask her questions about 12 the AASLD and the FDA in this document. 13 we believe this testimony is proper, Your Honor. 14 If Your Honor lets it in, I think it THE COURT: Give me the history of how the 15 AASLD was formed. 16 but how was that group created? 17 And that's why How was that agency -- not agency -- MR. TISI: Let me answer that question 18 correctly, Judge. 19 think everybody agrees in this case -- in fact, all the 20 hepatology witnesses are members of the organization. 21 It's not unlike professional organizations that you 22 might be more familiar with, like the American College 23 of Cardiology, the American College of Radiology. 24 25 The AASLD is analogous -- and I THE COURT: It's not the same thing as a liver study group, right? Golkow Technologies, Inc. Page 74 August 31, 2015 1 MR. TISI: 2 THE COURT: 3 No. Liver study group was formed by the FDA, and people were paid by the FDA. 4 MR. TISI: This is a professional 5 organization, like I said, like the American College of 6 Cardiology. 7 every hepatologist and gastroenterologist are members 8 of the organization. 9 Association, for example. 10 It was formed in the 1950s. Virtually It's like the American Bar It is the largest hepatology organization 11 of professionals in the country. 12 comparable one in Europe. 13 worldwide organizations with hepatology who study liver 14 diseases. 15 I think there's a And these are the two major Okay. So it's a smaller group, for example, than 16 the American College of Radiology, for example, just 17 because liver disease is much more of a discrete topic. 18 But it -- and to the extent -- we had this 19 argument, frankly, last week before Judge Stengel. 20 It's a very -- it is the standards-setting organization 21 for hepatologists. 22 presented an article, for example, the AASLD writes 23 papers in their Journal of Hepatology. 24 paper on acute liver failure, which the defendants have 25 relied on in their -- and their experts have relied on. Golkow Technologies, Inc. In fact, we saw last week, and I It's a position Page 75 August 31, 2015 1 So it's a very large organization. 2 The reason why this came about -- 3 THE COURT: 4 What weight am I supposed to give to their opinions? 5 MR. TISI: The same weight, for example -- 6 well, let me put it this way. 7 is supposed to give and the weight that the experts are 8 supposed to give. 9 10 THE COURT: It's the weight the jury What weight do I give it before the jury hears it? 11 MR. TISI: Well, the weight -- the test, to 12 me, is Rule 703, which is, is this the kind of 13 information that an expert relies on? 14 that to happen. 15 hepatologist, whether it be a toxicologist, whether it 16 be a drug-induced liver disease expert, they all would 17 look to -- and, in fact, the defendants' experts have 18 looked to the American Association of the Study of 19 Liver Disease for their opinions. 20 21 Well, 703 allows And frankly, whether it be a Are their opinions final? No, they are not final. 22 But they are considered to be part of the 23 spectrum of evidence that experts are supposed to be 24 relying on. 25 In fact, if the AASLD had come down and Golkow Technologies, Inc. Page 76 August 31, 2015 1 said, "You know, we've looked at the safety profile of 2 acetaminophen. 3 on the face of the earth," the experts still would be 4 able to rely on it. 5 witness. 6 We think it's the most fantastic drug I would have to cross-examine that But the truth of the matter is, you can't 7 ignore -- you can't ignore the statements of major 8 medical organizations on major medical topics that they 9 weigh in on. 10 THE COURT: 11 MR. TISI: 12 But the FDA did, though, right? The FDA considered it. is proof that the jury should consider it. 13 This is the -- 14 THE COURT: 15 And that The FDA did not adopt the recommendations. 16 MR. TISI: The fact that -- the FDA has not 17 weighed in on all of the issues on these cases. 18 is still a tentative final monograph, Your Honor. 19 point of the matter is the jury is going to say -- the 20 jury is going to -- what information did you have, 21 defendants, at your disposal? 22 this topic? 23 you consider the opinions of learned people? 24 25 This The Who was weighing in on Did you consider all the evidence? Did We have an exception to the hearsay rule. Do you consider learned treatises? Golkow Technologies, Inc. Do you consider all Page 77 August 31, 2015 1 the evidence? 2 And all we want to do in this case is to 3 present a jury with the accurate information and the 4 accurate environment in which the defendant was acting 5 at the time. 6 If the shoe was on the other foot, Judge, 7 and I would agree with this, if you've seen it in 8 another case, where all the major medical organizations 9 had come down against my position in this case, you 10 should allow that in, because it bears upon the 11 questions that the jury -- whether my expert has any 12 credibility and whether the jury should consider my 13 position to be valid. 14 Here we have the opposite. We have 15 virtually every medical person who looked at this issue 16 from a regulatory standpoint, from a safety standpoint, 17 from an efficacy standpoint, who weighed in on this and 18 told McNeil, "We think this has an inadequate margin of 19 safety. 20 public health issue, hepatotoxicity." 21 the 2006 proposed rule says. 22 23 24 25 We think this drug is creating -- is a serious And here's why. And that's what And among those reasons are, these various groups weighed in on the topic. That's something that an expert is entitled to rely on in support of their opinions. Golkow Technologies, Inc. In fact, they Page 78 August 31, 2015 1 2 would be remiss if they didn't. So the question really becomes specific to 3 this motion in this case, and we've kind of jumped 4 ahead to the admissibility of the AASLD document. 5 But the issue was, and I have 6 Judge Higbee's -- it's remarkable how this has taken a 7 life on its own. 8 which she issued to the AASLD in this case and, Your 9 Honor, I'm happy to provide it to you. I have Judge Higbee's commission 10 THE COURT: 11 MR. TISI: Sure. This is the schedule of 12 documents that I pulled from the motion. 13 now I don't have it in front of me. 14 very clear what I asked. 15 come on the stand and say, you know, we have this 16 recommendation out there by this major medical 17 organization. 18 organization is? 19 Okay. And But it's really I wanted to have a witness Can you tell us who this major medical Well, answering the question that you 20 proposed before, it is a 50-year organization; their 21 mission is to do this. 22 This is what they do. How did this document -- then the second 23 question was, how did this come about? 24 we got this proposal from the FDA. 25 in on the organization. Golkow Technologies, Inc. Well, you know, We wanted to weigh We brought it to our board of Page 79 August 31, 2015 1 governors, which is made up of five medical doctors: 2 past president, current president, future president, 3 and two other people. 4 had them peer-review it. 5 a recommendation. 6 it to everyone in the medical community. 7 to the FDA. 8 9 10 We had them weigh in on it. We And they issued -- they sent They sent it to McNeil. They sent They sent it I did not ask, and you will not find anywhere in that document, what is the scientific basis for this recommendation? 11 I didn't ask that. And that's why, when the American 12 Association for the Study of Liver Diseases answered 13 this 30(b)(6) deposition, they didn't produce the 14 president of the organization, who was a doctor. 15 didn't produce its company -- its lawyer. 16 produce its researcher. 17 director with no medical training, no regulatory 18 training whatsoever, just to basically walk through 19 this. 20 They They didn't They produced the executive Now, you know, the analogy that my 21 colleague keeps asking me to do here, to give you here, 22 it's like this. 23 opinion that Your Honor issued last week, you know 24 the -- you had read the cases, you've done the 25 analysis, you issued your opinion. If Your Honor were to issue -- the Golkow Technologies, Inc. Page 80 August 31, 2015 1 If, for some reason, in another case, the 2 fact of you issuing that opinion became important for 3 some reason, and I asked -- I issued a 30(b)(6) 4 deposition under the rules here and I said, "I want to 5 have somebody tell me when was it authored. 6 Judge Johnson? 7 When was it issued, and how was it distributed?" the 8 clerk's office might designate somebody like the clerk 9 to give that -- to give that opinion. 10 Who was Was he a valid commissioned judge? It would be unfair to that witness, once 11 that witness is in the stand, to then turn around and 12 say, "Oh, by the way, this paragraph here that 13 Judge Johnson wrote in this issue, how did he analyze 14 the Smith versus Jones case, and why did he come to 15 this conclusion that this case?" is better than that 16 case. 17 That's what happened here. I wasn't here when -- I was there when this 18 witness was deposed. 19 case. 20 don't know what the arguments made were. 21 It was the first witness in the I wasn't here when it was argued last year, so I I will tell you this. Sherrie Cathcart -- 22 the AASLD was a third party. 23 six hours, and she kept saying over and over and over 24 again, "I'm not a doctor. 25 very uncomfortable for me. Golkow Technologies, Inc. She sat in that chair for I'm not a lawyer. This is You know, this is outside Page 81 August 31, 2015 1 the scope of what I know." 2 were being asked by Mr. Hewes, and he kept going. 3 there was a judge in a room and I objected, that 4 deposition would have been stopped halfway through. 5 And all these questions If What happened to this witness was very 6 unfair. 7 question: 8 Was it just something that was willy-nilly thrown 9 across the transom of the FDA? All I called her on was a very simple "When was this issued? How was it vetted? And how did you 10 communicate it? 11 did you put it in an envelope and send it to the FDA 12 and nobody else saw it?" 13 Did you send it out or was it some -- Because my major concern was the company 14 got a copy of it. 15 questioning of that witness, where I ask the question, 16 you know, when you made this recommendation, what was 17 the basis of that recommendation? 18 expect this to be adopted by the FDA under a regulatory 19 scheme? 20 And so you will look in vain in my There was none of that. What was -- did you That only came in 21 Mr. Hewes' questions. 22 that witness sat in the chair and said, "I'm not an 23 expert. 24 in the colloquy, the AASLD lawyer came up and said, you 25 know, this is really way outside of the scope. And almost every single time I'm not a" -- and, in fact, at several points Golkow Technologies, Inc. Page 82 August 31, 2015 1 So we really have two questions here. 2 Number one is whether or not this was properly within 3 the scope to bind the AASLD. 4 questions that were asked of Sherrie Cathcart were not 5 properly within the scope. 6 This was not -- the And, second, even if you were outside the 7 scope, were the questions that were asked within the 8 competency of the witness? 9 bigger problem. And that, to me, is the 10 THE COURT: That's my biggest concern. 11 MR. TISI: That is the biggest concern. 12 THE COURT: I don't want the jury to hear 13 opinions that the witness was not competent to talk 14 about. 15 why I'm reconsidering it now. 16 And that's why I denied your motion, and that's But using your analogy, I need -- and I'm 17 not saying I'm going to preclude any discussion at all 18 from this group's findings and recommendations, but I 19 sure as heck know the jury needs to understand some 20 perspective objectively at what the weight of all this 21 is. 22 I mean, using your analogy of the American 23 Bar Association, you have a decider here. 24 American Bar Association, the decider is whatever Court 25 they are making a recommendation to. Golkow Technologies, Inc. And the And the FDA, they Page 83 August 31, 2015 1 are the decider. 2 recommends something to the state supreme court, and 3 the state supreme court can ignore it -- The New Jersey Bar Association 4 MR. TISI: 5 THE COURT: And you know that --- and the same thing here with 6 the FDA. 7 recommendation from either group is, you know, taboo 8 for discussion. 9 understand that the decider did embrace it. I'm not saying that none of that 10 But I am saying the jury needs to MR. TISI: And what I'm trying to tell you, 11 Judge, is I don't disagree with your analysis to this 12 extent. 13 with respect to the safety of this drug. Number one, the FDA did not decide anything 14 15 THE COURT: the same effect as a decision, isn't it? 16 17 20 21 That's Is it not? How long ago did they make this recommendation? 18 19 Well, they ignored it. MR. TISI: They made the recommendation in 2007, Judge. THE COURT: Okay. Well, eight years is enough time to decide if they embrace it or not, right? 22 MR. TISI: 23 THE COURT: 24 about the real world. 25 not embrace it. Well, you know -Come on. You want to talk The real world is that FDA did That's the real world. Golkow Technologies, Inc. Page 84 August 31, 2015 1 MR. MILLING: 2 THE COURT: 3 And they could have. know you say they should have. 4 5 May I be heard? MR. MILLING: they should have. 6 But they didn't. No, no, no. Back up. THE COURT: And I We don't say No. The AASLD -I've heard about the -- 7 I've heard about these recommendations for quite a 8 while. 9 hasn't embraced it. The long and the short of it is, the decider 10 MR. TISI: 11 THE COURT: 12 No, no, no, no. MR. MILLING: No, sir. THE COURT: 16 MR. MILLING: Yeah. The AASLD put out comments, that -- those comments about the safety of -- 18 THE COURT: 19 MR. MILLING: 20 21 22 23 The FDA in 2006 asked stakeholders for comments on various issues. 15 17 The recommendations were made to the FDA, were they not? 13 14 The decider is McNeil. them. The FDA got those comments out. FDA got them. McNeil got Everybody -THE COURT: What did FDA do with them other than file them? MR. MILLING: FDA filed them. Just be -- 24 and as you know from reading the statement of facts, 25 FDA has said -- when Mr. Hewes says FDA hasn't adopted Golkow Technologies, Inc. Page 85 August 31, 2015 1 that, that's going to open the door, respectfully, for 2 us to talk about the monograph system. 3 now said, "This system is so slow, we cannot" -- 4 they've said, "We cannot move quickly on OTC drugs for 5 safety reasons." 6 2009 final rule, they are saying we are delaying issues 7 of the maximum safe dose, fasting, these other issues, 8 because we want to get this one document out in 2009 on 9 the severe liver warning. 10 Because FDA has So what the FDA did, if you read the The next thing that happened with the FDA 11 is they wrote in 2014 in the Federal Register and said, 12 "We want to revamp the whole system, because we 13 said" -- and it says that we the FDA cannot do what we 14 do with prescription drugs. 15 the rulemaking and lengthy bureaucratic process of the 16 monograph. 17 We cannot do it through So when Mr. Hewes stands up and says they 18 rejected it, they didn't reject it. 19 of the 2009 rule, they said, "We're going to consider 20 it when there's more data, and we're going to consider 21 it in the future." 22 On the first page Number one. Number two, then they said, "The system is 23 too slow. 24 the prescriptions. 25 acetaminophen in prescriptions, we did it. We can't do anything." Golkow Technologies, Inc. You saw us react to When the advisor said take them, We can't do Page 86 August 31, 2015 1 it; McNeil has to do it. 2 3 And so, two things. There's been no rejection -- three things. 4 Number two, the AASLD memo is part of 5 pharmacovigilance. 6 testified -- Every witness at McNeil 7 THE COURT: 8 have the power to say to McNeil -- 9 MR. TISI: 10 You're saying the FDA doesn't No, they don't. THE COURT: They don't have the power to 11 say, you know, "This group has got it right; you've got 12 to change things"? 13 that? 14 They don't have the power to say MR. MILLING: Not on the monograph. It is 15 a rulemaking process. 16 points and the cites of the document on the omnibus 17 statement of facts. 18 said, "We cannot do it." 19 power on the monograph system, which everybody thought 20 was a great system in 1972. 21 worked out. 22 unfinalized. 23 has said that. You saw it at the end of the They've come out publicly and The FDA does not have the But it's not. It hasn't Those monographs, 20 percent are still There's still so many questions. 24 So what I would say to you -- 25 THE COURT: Golkow Technologies, Inc. The FDA You know, I'm sitting here Page 87 August 31, 2015 1 thinking, you know, you really run the risk of making 2 some of these issues really big for jurors. 3 MR. MILLING: Well, the problem is if 4 Mr. Hewes says -- first of all, as to the AASLD, the 5 memo was highly vetted within every one of the -- 6 within the corporate executives and the medical 7 department at McNeil. 8 it's part of the case. 9 THE COURT: It's part of their knowledge; It ends -I am not saying to you it's 10 irrelevant. 11 know, directly broader, you know, what weight is going 12 to be allowed to be attributed to it. 13 14 15 I'm saying to you -- I'm trying to -- you MR. MILLING: And the weight will be -- it's part of the lines of evidence that are considered. THE COURT: And I'm reversing myself to an 16 extent that I do want to look carefully at the 17 questions that are asked of Ms. Cathcart, because I'm 18 not going to have -- and I'm speaking to defense 19 counsel, and I want them to reply. 20 have her talking about things that she's not qualified 21 to talk about, simply because you guys pushed her on 22 the issue and she felt she had to -- in looking at 23 portions of it, she was pushed. 24 25 MR. HEWES: I'm not going to Yes, Your Honor. And a lot of it, as you recall from last year, we withdrew some of Golkow Technologies, Inc. Page 88 August 31, 2015 1 it that probably was beyond the scope of her 2 qualifications. 3 But throughout the deposition, I went back 4 and I made sure to ask her that she was providing the 5 AASLD's opinion, the AASLD's position on these issues. 6 She said it was the AASLD's position. 7 8 9 10 11 THE COURT: Probably as best she understood MR. HEWES: As best she could. it. And I don't quite know where to begin responding -THE COURT: I'm not comfortable with 12 somebody like her opining on different issues as best 13 she understood it. 14 We've got witnesses that are going to talk about the 15 recommendations, and the witnesses will be 16 cross-examined. 17 been embraced by FDA after eight years. 18 have done something more than say nothing. 19 We've got the recommendations. We've got the fact that it's never They could And so what I want to make clear to the 20 defense is, when we play whatever testimony of hers is 21 going to be played, that whatever portions of the 22 cross-examination are played are ones that are going to 23 be within the scope of the direct. 24 MR. HEWES: 25 Yes, Your Honor. And whether the FDA followed the AASLD recommendations is not a Golkow Technologies, Inc. Page 89 August 31, 2015 1 scientific question. 2 authority is not a scientific question. Whether the AASLD is a rulemaking 3 MR. TISI: 4 MR. HEWES: Let me finish. 5 THE COURT: You are interrupting him. 6 MR. TISI: 7 MR. HEWES: But -- I'm sorry, Judge. And to suggest that our experts 8 relied on this document is not the case, Your Honor. 9 None of our experts relied on a memorandum by the AASLD 10 in forming their opinions, number one. 11 Number two -- 12 THE COURT: 13 14 But they didn't ignore it either, did they? MR. HEWES: Well, 703.7, Your Honor, allows 15 experts to consider hearsay documents in their context. 16 To read 703.7 -- 17 THE COURT: 18 whatever other experts considered. 19 MR. HEWES: They're allowed to consider Nevertheless, in 703.7, hearsay 20 statements relied upon by an expert are generally -- 21 are admissible for the limited purpose of apprising the 22 jury of the basis of their opinion. 23 THE COURT: Correct. 24 MR. HEWES: So if they relied on this 25 document, it doesn't mean the document comes in. Golkow Technologies, Inc. Page 90 August 31, 2015 1 2 THE COURT: comes in. It doesn't mean the document 3 You're correct. MR. HEWES: And to suggest that the FDA 4 didn't weigh in on this, Your Honor -- and I've got two 5 cites just to put them in the record. 6 Federal Register -- specifically on Page 19391 and on 7 Page 19377 -- in 19391, the FDA expressly talked about 8 the 2006 memorandum. 9 But the 2009 And the FDA said this when the AASLD 10 suggested that the label should be changed to reflect 11 an increased risk of liver damage when using 12 acetaminophen for more than five days. 13 direct quote from the FDA talking about the AASLD 14 memorandum: 15 to support this recommendation." 16 17 18 19 This is a "The submission does not include any data So there's no doubt that this memorandum was considered by the FDA. THE COURT: There's no doubt the jury is going to hear that too. 20 MR. TISI: I'm fine with that. 21 THE COURT: I'm sure you are. I'm going to 22 permit experts to reference that document, because 23 experts do look at what other experts do. 24 they sometimes learn about what other experts do is to 25 read a hearsay document. Golkow Technologies, Inc. The only way The document itself, I don't Page 91 August 31, 2015 1 know what value that would be giving it to the jury for 2 them to read. 3 4 I think it would be beyond their -- MR. TISI: I would answer that question to say -- 5 THE COURT: 6 MR. TISI: 7 Hold on. I thought you were directing it to me. 8 THE COURT: 9 What I'm saying is, so that they know, a 10 lot of their witnesses, and I don't know who they're 11 planning on being the ones that we'll talk about, are 12 going to be permitted to reference this document. 13 MR. HEWES: I'm not. I don't disagree. I think 14 703.7 allows them to reference the document. 15 don't think it allows them to go into the context and 16 content of the document. 17 that was, despite what was weighed in by the FDA, and 18 the FDA weighed in on it, Your Honor, and issued a 19 final rule. 20 do? 21 But I That is pure hearsay. And And after weighing in on it, what did they They added one word to the label. After reviewing this document, after 22 reviewing the documents from everybody else since 2002, 23 they did weigh in on it. 24 25 And that was the end result. But the content of a document, Your Honor, hit it on the head. Golkow Technologies, Inc. It's like an associate writes a Page 92 August 31, 2015 1 brief and suggests I file the brief in this case. 2 associates are probably smarter than me anyway, so I'd 3 probably give it a lot of weight. 4 adopt it. 5 Most I don't have to That brief may never get filed. In the book-publishing business, you send 6 your book out to a small publishing house, one that 7 creates space route. 8 story editor. 9 are the final arbiter of what is included in that book. 10 And this was submitted to the FDA, and they You send it to a copy editor or a They make edits. But you as the author 11 are going to talk about it too. 12 2008 working group document was submitted to the FDA, 13 and the FDA considered it. 14 that, in the context of acetaminophen, oh, the FDA was 15 too busy. 16 didn't have time to look at it. 17 40-page document in the 2009 Federal Register. 18 walked through what they considered. 19 This working group -- There's no evidence to say Oh, the monograph system is broken. The FDA The FDA has about a They And the FDA did not adopt any of the 20 recommendations in the AASLD or the working group, 21 which we're going to talk about later, as it relates to 22 over-the-counter acetaminophen. 23 suggest or spin or use it as a Trojan horse to get all 24 this other stuff in that the FDA didn't rely on, is not 25 proper in the case. Golkow Technologies, Inc. Not one. And so to It's a hearsay document. If Your Page 93 August 31, 2015 1 Honor allows the document to come in, in the context of 2 the document, surely the testimony of Sherrie Cathcart, 3 putting the document in context, saying it was never 4 adopted by the FDA, saying it is not a rulemaking 5 document for purposes of pharmaceutical companies, 6 surely that would come in in the context of the review 7 of the discussion of the AASLD document. 8 9 10 MR. TISI: second. Judge, let me back up for a I want to use Mr. Hewes' example, because it is the perfect example. 11 If Mr. Mayes prepares a brief for Mr. Hewes 12 to file, and he makes the ultimate decision to not 13 file, and his client files a malpractice claim against 14 Mr. Hewes for not making a proper argument, the memo 15 that Mr. Mayes provided to Mr. Hewes is relevant for 16 Mr. Hewes' knowledge, the notice that he was given to 17 make an argument that he failed to make, number one. 18 And an expert, a malpractice expert, an 19 expert, would be able to rely on Mr. Mayes' memo to 20 say, you know, "Mr. Hewes was told about this. 21 a decision not to do it. 22 it." 23 He made It is malpractice not to do So my point is, is this, Judge: This is 24 part of the spectrum of evidence. 25 experts -- we went through this in detail last week. Golkow Technologies, Inc. Each one of our Page 94 August 31, 2015 1 Each of the experts in this case has independently 2 explored the bases for epidemiology, clinical trials, 3 case reports, all of that stuff. 4 In addition to looking at that, to 5 basically validate their own opinions in this case 6 about margin of safety, about the things that are 7 important to this case, one of the things that they 8 consider is, what do other experts in the field say 9 contemporaneous about this issue? 10 And so whether it be Dr. Blume, 11 Dr. Plunkett, Dr. Kaplowicz, any of these people in 12 this case, they say, "Look, it's not only me. 13 at the evidence myself, but it's the people at the FDA 14 working group who looked at it. 15 looked at it. 16 17 18 I looked It's the AASLD who They all looked at it." And you know something? That's one of the things that experts rely on. Now, on whether the document comes in 19 itself, I would agree that, first of all, I would think 20 that the document is, in fact, a business record of -- 21 and it would come in under the hearsay exception. 22 But even if it wasn't, it was a document 23 that was provided to this company in 2006, which was, 24 frankly, the reason why I took Sherrie Cathcart's 25 deposition in the first place, to establish this wasn't Golkow Technologies, Inc. Page 95 August 31, 2015 1 sent under cover of night to the FDA and that McNeil 2 never got a copy of it. 3 It was done in the very beginning part of 4 this case to establish the fact that they got this 5 memo, notice, and notice to do something. 6 would agree with you. 7 and the witness is testifying to, well, the FDA -- the 8 AASLD had said 4 grams is unsafe in some people, they 9 can come back and cross-examine the witness. If the witness is on the stand 10 FDA didn't believe you. 11 That's valid cross-examination. 12 all about. 13 You know, I Well, the So-and-so didn't believe you. That's what this is So, really, where I come out and where I 14 would advocate to you, Judge, is this: 15 comes in because it was provided to them as notice. 16 can be relied on under 703 as something an expert 17 typically relies on, subject to cross-examination. 18 The document It The issue with Sherrie Cathcart, she should 19 be strictly prescribed to the reason why she was 20 called. 21 30(b)(6) witness of McNeil, I'm sure a little bit more 22 latitude would be given. 23 was called for a very specific purpose. 24 25 I'm sure that the Court -- if this was a This is a third party. She I would even grant you, if they went outside the scope of that limited purpose, but the Golkow Technologies, Inc. Page 96 August 31, 2015 1 witness actually knew the answers to the questions, you 2 might have some latitude. 3 did over and over again -- and I can read it to you -- 4 "I'm uncomfortable. 5 as to whether or not Dr. Lee" -- 6 If the witness says, as she I'm not a doctor. THE COURT: I can't testify I'm going to be very sensitive 7 to that. And the motion is granted in part and denied 8 in part. We'll have to look at the questions that are 9 posed, but I'm not going to have a witness testifying 10 to things that she admittedly is uncomfortable to 11 because it's beyond her knowledge. 12 MR. TISI: I prepared a chart that lays 13 out -- in fact, I have a chart here. 14 example, that the testimony about the meaning and 15 interpretation of FDA regulation -- 16 17 THE COURT: It says, for That's going to be helpful to me. 18 MR. TISI: 19 THE COURT: 20 MR. TISI: And I prepared it, and -Do they have a copy of it? Yes, they do. And it goes 21 through -- for example, she was asked, "What does the 22 FDA mean when they say X, Y, and Z?" 23 Here it is, Judge. 24 of it. 25 will help guide you. I think you have a copy I have a copy of it here. Golkow Technologies, Inc. And I think that When we were doing this last Page 97 August 31, 2015 1 time -- 2 3 THE COURT: Okay. The motion is denied in part and granted in part. 4 And the next subject is: Exclude any 5 reference to the risk of adverse events from 6 medications other than acetaminophen. 7 that? 8 9 MR. MILLING: Why would I do Your Honor, the issue for the jury in this case is very simple. As it relates to the 10 Taylor case, did the company properly warn consumers, 11 including Ms. Taylor, of the risks associated with 12 acetaminophen? 13 this case is that it caused anywhere from light DILI 14 all the way through ALF and death, at a lower margin of 15 safety than has been represented to the public. 16 the issue. The risk that we're talking about in That's 17 Second issue as to both cases is, is that 18 low margin of safety dangerous, rendering the product 19 defectively designed at the time it was -- forget about 20 the plaintiff -- at the time it was on the shelf? 21 Those are the issues. 22 The defense to that issue cannot be -- is 23 not relevant to say, "Well, if we warn about that" -- 24 and this is relevant if we are talking to the FDA in an 25 academic sense. "If we warn about that, people have to Golkow Technologies, Inc. Page 98 August 31, 2015 1 switch to nonsteroids. 2 you may have stomach bleeding." 3 If you switch to nonsteroids, That's going to open the question. Are you 4 talking about over-the-counter nonsteroids? 5 talking about prescription nonsteroids? 6 talking about the Voltaren that I take, which is a 7 24-hour extended-release? 8 in this case. 9 10 THE COURT: Are you Are you That has not been discovered That's why it's real unlikely we're going to have any conversation about it at all. 11 MR. MILLING: 12 THE COURT: Okay. 13 MR. HEWES: Can I address it real quick. 14 One of the plaintiffs' themes that you keep Thank you very much. 15 hearing about and we heard about in prior hearings is 16 that they try to beat us up because we say it's the 17 safest alternative analgesic or it's the safest 18 over-the-counter analgesic. 19 Honor -- may I approach? 20 raised by Mr. Milling, there is a large body of 21 evidence, and this is just a snapshot of it, discussing 22 acetaminophen -- discussing NSAIDs at over-the-counter 23 doses showing that not only is there an increased 24 cardiovascular risk in taking the over-the-counter 25 dose, but there is an increased risk of GI bleeds and Golkow Technologies, Inc. If they say that, Your To address some of the issues Page 99 August 31, 2015 1 death when taking that over-the-counter dose. 2 matter of fact, as I cite here, such as a twofold risk, 3 relative risk of two, of taking over-the-counter 4 acetaminophens -- excuse me -- over-the-counter NSAIDs, 5 it doesn't matter if you take it once or take it 20 6 times, you can suffer -- if the plaintiffs are going to 7 set forth to the jury that we're arguing that 8 acetaminophen is the safest drug or that that's just a 9 made-up, fictional argument, then we certainly should As a 10 be allowed to say that, of the over-the-counter 11 options, when taken at recommended doses, acetaminophen 12 has less of a risk than these other options that are 13 out there. 14 MR. KOTT: I would add to that, Your Honor, 15 one of the arguments that the plaintiffs made -- and 16 they've made hundreds of them -- is that extra strength 17 should only be offered in the prescription form, and, 18 therefore, we should be allowed to suggest to the jury 19 under -- 20 21 22 THE COURT: I don't think they are going to have a witness that is probably going to say that. MR. KOTT: -- and, therefore, we should be 23 allowed to argue to the jury that if that happens, 24 because we know people don't want to go to the doctor, 25 either can't afford to, they don't like to, they are Golkow Technologies, Inc. Page 100 August 31, 2015 1 then going to the local CVS or Walgreens and purchasing 2 a competitive over-the-counter pain reliever. 3 would be simply unfair for the plaintiffs to say that 4 Extra Strength Tylenol ought to only be by prescription 5 and then not let us talk about what that would result 6 in. 7 THE COURT: And it And I think, Mr. Milling -- I 8 hope you're going to agree with me -- to the extent 9 that they can or can't talk about -- how do you say it, 10 NSAIDs? 11 MR. HEWES: Yes. 12 THE COURT: That is the terminology? 13 -- to talk about NSAIDs is going to be -- 14 I'm going to be guided by your proofs. 15 this motion, I'm neither going to grant it nor deny it. 16 I'm going to wait to see what develops in your proofs. 17 So it's neither granted nor denied. 18 19 MR. MILLING: you? So in terms of You asked me to agree with I'll agree with you to -- 20 THE COURT: 21 MR. MILLING: You don't have to. I ruled. The only thing I just want 22 the Court to be aware of, there has been no expert 23 testimony on this. 24 NSAIDs, just so you know. 25 There's been no discovery on THE COURT: Golkow Technologies, Inc. Again -- I don't know how far you're Page 101 August 31, 2015 1 going to go in condemning acetaminophen. 2 MR. MILLING: I understand. I do think, 3 though, that NSAIDs are a different -- little bit 4 different animal in that -- 5 THE COURT: 6 MR. MILLING: Sounds like they are. They are different also in 7 dosage, because one Motrin is this level of an NSAID. 8 One prescription Motrin is this level of an NSAID. 9 In acetaminophen, 500 milligrams is this 10 level of acetaminophen, and the FDA has reduced 11 prescription -- 12 THE COURT: 13 MR. MILLING: 14 I'm aware of that. -- down. So they are backwards. 15 So what I don't want is us to be in a 16 position where I could never cross-examine an expert on 17 the risk of GI bleeds off of NSAIDs, because I don't 18 know whether the GI bleeds' literature -- it hasn't 19 been part of this case -- I don't know whether it comes 20 from -- predominantly from -- I believe it comes 21 predominantly from prescription NSAIDs taken in elderly 22 people for a long period of time, not from 23 over-the-counter Motrin taken for a headache. 24 25 But what's going to end up happening is classic 403. We're going to end up with a jury trying Golkow Technologies, Inc. Page 102 August 31, 2015 1 to put all this together, we're going to spin off into 2 mini trials over issues that haven't been discovered in 3 this case, and that's all I want to say. 4 THE COURT: 5 Okay. I don't want that to happen. Preclude the inference that there is 6 a lack of randomized controlled trials relating to 7 acetaminophen and acute liver failure for any reason 8 other than the fact that such studies are unethical and 9 virtually impossible to design. 10 Well, tell me why I should grant that. 11 MR. HORN: 12 motion, I grant you that. 13 14 15 Your Honor, this is an unusual THE COURT: It is. And this is a tough issue. MR. HORN: It is a very tough issue. I 16 can -- it was referred to as a kamikaze mission by one 17 of my colleagues back at my office, this motion, but I 18 said I'll take the hit. 19 20 21 22 23 24 25 I'll tell you how it happened. True story. He's not here, but it's a true story. THE COURT: Well, he ought to be the one here arguing it. MR. HORN: I don't disagree with Your Honor, but you're stuck with me. One, there is a thread through this case Golkow Technologies, Inc. Page 103 August 31, 2015 1 that the defense is putting into play. 2 through their experts and through their crosses of our 3 experts. 4 of our experts, defense counsel asked, "There's no 5 trial that shows it over 4 grams, is there? 6 study, there's no study, there's no study, clinical 7 study, randomized study. 8 failure." It's done For example, in every deposition taken of any There's no You can't show acute liver They've asked numerous times. 9 Their experts in their reports and in their 10 opinions all state, "We recommend under 4 grams, but 11 there's absolutely no data that anybody can show you 12 that under 4 grams it causes liver failure. 13 there's no study that shows it. 14 defense expert to tell you that." 15 16 And And I'm here as the Now the problem is -- so that's the -that's the thread. 17 That's the -- THE COURT: 18 testimony. 19 cross-examination. You are going to hear that 20 So let's talk about the limits of your All right? MR. HORN: Well, hopefully before the -- 21 before you rule, let me get -- just bear with me one 22 more minute. 23 THE COURT: 24 MR. HORN: 25 THE COURT: Golkow Technologies, Inc. I'm not ruling. I'm setting the stage -You set it up. Right? We know Page 104 August 31, 2015 1 we're going to hear that testimony. 2 MR. HORN: 3 won't. 4 kamikaze part of this. 5 in a minute. And let me just explain why, and that's the 6 7 THE COURT: And maybe we'll get to stage 2 I don't know. I think you're going to have to be able to counter it. 8 9 Well, if I'm successful, they MR. HORN: Here I go. Here is the problem, Judge. 10 Their own experts -- for example, Dr. Flann 11 testified it would be very hard to do a study like he's 12 referencing. 13 said -- and it's in our motion, Judge. 14 seen it -- his own testimony was they couldn't figure 15 out how to ethically do this study because it gets too 16 dangerous with dosage. 17 Dr. Temple, the defense's own employee, I'm sure you've They couldn't get it done. So you have Dr. Flann, Dr. McKay, 18 Dr. Temple all saying, the study they're all saying 19 doesn't exist, couldn't be done. 20 So here is the problem. The problem is, if 21 you get a really good expert -- and I can tell you, 22 Dr. Flann, impressive guy. 23 great cred -- he talks about being the biggest hotshot 24 at Northwestern. 25 Dr. McKay is going to get up there and say, "I'm the I saw him, talked to him, He's all these, NIH, everything. Golkow Technologies, Inc. Page 105 August 31, 2015 1 head of poison control. 2 government. 3 impressive guys, and that's fine. 4 should hire. 5 I do grants for the FEMA comes to me." These are very That's who they But when a guy that -- with those kinds of 6 creds, when he puts his creds into play, then says, 7 "And, members of the jury, you have to trust me, 8 because I'm telling you there's no study to say what 9 the plaintiffs are asking you to believe; the science 10 doesn't exist," when, in fact we don't know, because we 11 heard from Dr. Temple, and Dr. Flann has already 12 admitted, that that study couldn't be done and nobody 13 has figured out how to do it, then we have a 14 sword-and-shield problem. 15 is they're using this concept to the jury, when, in 16 fact, they also know it couldn't be done. 17 Because what they're doing Now, I understand Your Honor's remedy, 18 which is fair, because that's what most people would 19 say. 20 cross him on that. 21 testimony. That's cross-examination. 22 I get it. We can We can show him Dr. Temple's I understand that. But here is the problem. Some bells can't 23 be unrung. 24 statement, which I'm sure they will -- they're good 25 lawyers -- and say, "Members of the jury, here is what When they get up in their opening Golkow Technologies, Inc. Page 106 August 31, 2015 1 I want you to know. 2 are going to show them the pyramid of evidence. 3 case reports are the worst, and randomized control 4 trials are the best. 5 and say, "This is the best piece of evidence that 6 everyone agrees, this is the most powerful evidence 7 that exists." 8 plaintiffs are right. 9 couldn't be done. 10 There is not one study" -- they The And they're going to get up there And guess what, none of that shows the When, in fact, we all know it And they concede it couldn't be done. 11 We're then in a situation where there are 12 bells that can't be unrung. 13 in a position where they could wildly speculate, "Why 14 don't these studies exist?" 15 could be too late. 16 this issue coming into trial, at the very least we're 17 going to ask for either a severe instruction or some 18 sort of real curtailment or maybe even an instruction 19 from Your Honor during the testimony or something like 20 that. 21 The jurors are going to be By the time we cross, it So if Your Honor won't preclude But my concern is there will be this 22 umbrella over the case which they are going to put into 23 play in their jury questionnaire, in their opening, and 24 their course of experts and in their experts' opinion, 25 that is going to say, "There's no study, there's no Golkow Technologies, Inc. Page 107 August 31, 2015 1 study, there's no study," when, in fact, it couldn't be 2 done. 3 Anyway, this is the issue I wanted to raise 4 with Your Honor, is how do we deal with this. 5 we deal with the fact that, at the same time they're 6 saying, hey, members of the jury, there's no study, but 7 you know what, we all know behind closed doors it 8 couldn't be done because it's unethical. 9 why I think it's unfair for the jury to even hear that 10 MR. JACKSON: Your Honor, if I could be heard -- 13 MR. HORN: 14 THE COURT: 15 And that's and us to try to remedy that on cross. 11 12 How do Mr. Jackson first. We're not done. I'm going to hear from He looks ready. 16 MR. JACKSON: 17 If I could, Your Honor, first of all, the Thank you, Your Honor. 18 motion that's been filed is different, really, from 19 what's been argued and it's much broader. 20 THE COURT: 21 MR. JACKSON: You are correct. The motion asks to preclude 22 any reference to the lack of randomized clinical trials 23 of acetaminophen. 24 there are -- first of all, there are at least 21 such 25 published clinical trials. As we pointed out in our response, Golkow Technologies, Inc. So, as a matter of fact, Page 108 August 31, 2015 1 the argument that the plaintiffs are making, which is 2 that you can't perform a randomized clinical trial to 3 assess the safety of acetaminophen, is belied by at 4 least 21 published, peer-reviewed, randomized clinical 5 trials assessing the safety of acetaminophen up to the 6 recommended dose and even beyond the recommended dose. 7 One of which, the Watkins-Kaplowicz -- 8 THE COURT: 9 And you were kind enough to give them to me. 10 MR. JACKSON: That's right, the ones we 11 found. 12 unpublished trials as well. And there are many more. 13 There are many The Watkins-Kaplowicz study, which 14 plaintiffs' own experts are relying on as a critical 15 piece of evidence in this case, is exactly such a 16 study. 17 So it is simply just objectively false to 18 our view that you cannot assess the safety of 19 acetaminophen in a randomized clinical trial. 20 everyone has said is you cannot design a randomized 21 clinical trial for the purpose of figuring out how much 22 acetaminophen you have to give a person before they 23 develop acute liver failure. 24 unethical. 25 What Obviously, that would be But that doesn't mean you can't have Golkow Technologies, Inc. Page 109 August 31, 2015 1 randomized clinical trials where you give recommended 2 doses and even slightly more than recommended doses of 3 acetaminophen to people, compare their reaction with 4 that of placebo or with other drugs, and assess the 5 product for safety. 6 21 studies. 7 found to be safe. 8 don't want the jury to hear, because it is high-grade, 9 high-quality scientific evidence. And that's been done in at least And in all of them, acetaminophen was And this is what the plaintiffs And in each and 10 every one of those clinical trials, there were no cases 11 of acute liver failure. 12 law. 13 I'm not surprised that the plaintiffs don't want to 14 talk about this evidence. 15 There were no cases of Hy's And there were no cases of hepatotoxicity. But it is out there. So And it's very 16 important evidence. 17 that we have. 18 anecdotal case reports that the plaintiffs want to talk 19 about ad nauseam. 20 there's no basis to hold it inadmissible. 21 It's the highest grade of evidence It's a much higher grade than these And it is clearly admissible, and Dr. Temple's testimony has been thoroughly 22 misconstrued. 23 him in full, what he said was they couldn't figure out 24 a way to design a fasting study that met their 25 specifications. We point out in our papers and quoted He didn't say it would be dangerous. Golkow Technologies, Inc. Page 110 August 31, 2015 1 He didn't say it would be unethical. 2 practically had difficulty with figuring out a way to 3 do the study. 4 They said they There have been studies -- in addition to 5 the randomized clinical trials, Your Honor, which is 6 not all we're talking about, there could be -- there's 7 absolutely no reason why a case-control study, which is 8 a controlled study, could not be designed to test some 9 of the theories that the plaintiffs have advanced in 10 11 this case. One of their experts, Dr. Nelson -- they 12 withdrew it in this case -- he admitted that he could 13 design such a study. 14 THE COURT: 15 MR. JACKSON: I read enough about Dr. Nelson. But we all -- there's 16 absolutely no reason, no ethical reason, that you 17 couldn't collect controls and compare them with the 18 cases, for example, that have been accumulated by the 19 acute liver failure study group, just as they did PPA, 20 that Mr. Tisi mentioned last week. 21 epidemiologic study in the PPA cases where they 22 collected people with stroke and compared them with 23 people that didn't have stroke to -- compared people 24 with stroke that hadn't been exposed to the 25 phenylpropanolamine in those cases. Golkow Technologies, Inc. They did an Page 111 August 31, 2015 1 But in any event, what they've said is 2 fodder for cross-examination, obviously. 3 can be cross-examined on this. 4 disputed that this argument that randomized clinical 5 trials shouldn't be discussed is just totally without 6 basis. 7 THE COURT: 8 MR. TISI: 9 But it cannot be Let me hear from Mr. Tisi. Judge, I think we're getting a little bit -- 10 11 The experts THE COURT: You're picking up on the kamikaze mission? 12 MR. TISI: Yeah, this is a little 13 obfuscating here. 14 nature -- and I'm sorry to get too wonky here. 15 a convention, the Helsinki Convention that was after 16 World War II, you cannot construct a human prospective 17 clinical trial that would test a hypothesis that Drug X 18 causes Harm Y. 19 After World War II, you cannot do it. 20 Clinical trials by their very That is not ethical. You cannot do it. These clinical trials that Mr. Jackson is 21 talking about are all efficacy trials. 22 work better than 5? 23 THE COURT: 24 MR. TISI: 25 But by Absolutely. Does 4 grams Is that irrelevant? No, it's not irrelevant. In fact, we want there to be clinicals. Golkow Technologies, Inc. Page 112 August 31, 2015 1 In every single clinical trial, there is an elevation 2 in ALT. That's all relevant. 3 We agree with that. The question that is very different, 4 they're going to -- you heard it over and over again. 5 You heard it in their attempt to cross-examine 6 Dr. Plunkett. 7 Okay. Is there any clinical trial that 8 demonstrates a risk of acute liver failure at 9 four grams? Okay. That's not -- that's a different 10 question than saying has any clinical trial patient 11 ever gotten acute liver failure. 12 The suggestion that they're making there is 13 the suggestion by the question that you can conduct a 14 clinical trial that tests the hypothesis that Dose X 15 can cause hospitalization or death. 16 Okay. You cannot do it. 17 And so we're not saying here -- the jury -- 18 and we want the testimony that experts can look at ALTs 19 in clinical trials. 20 safety in an efficacy trial. 21 are there things happening to patients that we didn't 22 expect. 23 at, blood pressures, liver enzymes. 24 people who have reactions. 25 Those are -- you always look at You always look and see, And that's a whole panel of things they look They look for That's all true. But none of those trials are testing a Golkow Technologies, Inc. Page 113 August 31, 2015 1 hypothesis where the primary goal of the study is, does 2 Drug X cause Harm Y. 3 And I would challenge counsel to 4 demonstrate a clinical trial where the hypothesis is, 5 we're going to give the patient X amount of drug in 6 order to see whether it causes a problem. 7 The second thing -- 8 MR. JACKSON: 9 THE COURT: Can I -Let him finish. 10 MR. TISI: 11 MR. JACKSON: 12 MR. TISI: Let me finish, Counsel. I'm sorry. I find it -- again, to try to 13 put this in perspective, I love the argument that 14 counsel make. They have a drug that's on the market 15 for 50 years. They continued to say, "It's so easy. 16 You just do a case-control prospective study." 17 18 What the jury is going to hear is, you have the drug. Have you ever designed such a study? 19 I mean, Mr. Jackson kind of went into the 20 whole issue of epidemiology, which is not the focus of 21 this motion. 22 and say, "Oh, it's so easy. 23 done," when in 50 years they've never done one study, 24 despite, you know, two advisory committees, despite 25 questions from the medical and scientific community. But, to me, it's ironic for him to get up Golkow Technologies, Inc. Everyone knows it can be Page 114 August 31, 2015 1 But for 20 and 30 years, they've never done one. 2 3 So that's going to be an issue that's plainly before the jury. 4 But the narrow focus in this motion in 5 limine is, can they get up there before this jury and 6 say, "Ladies and gentlemen, you will not hear one 7 study, one clinical trial that demonstrates that acute 8 liver failure statistically significantly is caused by 9 acetaminophen at 4 grams." 10 And if they want to make that claim, it is 11 patently unfair, because it's not only impossible to 12 design because it's a rare disease, from a technical 13 standpoint, it's unethical. 14 that. 15 It's against the law to do So that's why -- that's really where this 16 is. 17 there was a case that happened to show up in the 18 clinical trials, which, to my knowledge, there is not, 19 that's fodder for cross-examination. 20 comes in. 21 Clinical trials, absolutely in. Evidence, if Elevation in ALTs Fodder for cross-examination. But to take it one step further and to 22 argue that somehow there is a lack of a clinical trial 23 that tested the hypothesis that 4 grams causes acute 24 liver failure is wrong. 25 THE COURT: Golkow Technologies, Inc. Well, you may be hypothesizing Page 115 August 31, 2015 1 an argument that they don't plan on making. 2 Mr. Jackson. 3 MR. JACKSON: Your Honor, first of all, I 4 apologize. 5 I apologize to Mr. Tisi for doing that, because 6 everybody should be allowed to speak their piece, and I 7 apologize. I've been very good about not interrupting. 8 THE COURT: 9 MR. JACKSON: Thank you. Your Honor, remember in the 10 Jackson case, of course, it's not a case of acute liver 11 failure. 12 told is an injury, a compensable injury. 13 the case is going to be litigated about, apparently: 14 Elevation of a ALT or AST is a liver injury. It is a case of elevated enzymes, which we're 15 That's what Mr. Tisi just assured us there's never been 16 a trial where the objective was to assess whether 17 injury can occur from exposure to a drug. 18 would violate the Helsinki accords or what have you. 19 He said it I would simply, if I may approach, Your 20 Honor, hand up to you a study that the plaintiffs are 21 well aware of, which is the Watkins-Kaplowicz study, 22 which their own expert performed and the affiliations 23 of all these reputable institutions are there on the 24 first page. 25 And the objective of this study as Golkow Technologies, Inc. Page 116 August 31, 2015 1 described by the authors was to characterize the 2 incidence and magnitude of ALT elevations in healthy 3 participants receiving 4 grams of acetaminophen daily. 4 So here is a randomized clinical trial 5 doing what Mr. Tisi just told us a minute ago is 6 unethical and prohibited by all sorts of international 7 accords. 8 acetaminophen increases your liver enzymes, which they 9 are claiming in the case of Ms. Jackson is a It was a trial to test whether 4 grams of 10 compensable injury. 11 elevated enzymes. 12 It is a liver injury to have I think this motion is way overbroad. It's 13 attempting to exclude from evidence things which are 14 not only relevant, they're at the heart of the case. 15 And they go to the heart of claims being made by the 16 plaintiffs. 17 And we certainly should be entitled to 18 explore, subject to cross-examination, of course, with 19 all the experts in this case what the actual data are 20 about acetaminophen as published in the literature. 21 MR. MILLING: 22 THE COURT: My last comment -I'm going to let Mr. Horn know 23 that kamikaze mission hit the ocean, not the 24 battleship. 25 The motion is denied. Golkow Technologies, Inc. You'll deal with Page 117 August 31, 2015 1 this issue in cross-examination. 2 limit people's ability to present their case based upon 3 existent facts and based on existent expert 4 peer-reviewed articles. 5 cross-examine. 6 I'm not going to You'll just have to We're going to wrap up Taylor, and then 7 we're going to take a break, and then we're going to go 8 to Jackson. 9 Let's talk about them. 10 Exclude character evidence of plaintiff, Mrs. Taylor, or their family. 13 Why wouldn't I do that? I'm talking to the defense. 14 do that? 15 attributes. 16 anything? 17 They are not going to involve a whole lot. 11 12 And I think we have four Taylor-specific. Why wouldn't I I understand this woman had certain But how's her character any account of MR. MAYES: It would be if they open the 18 door to putting on testimony through the husband or 19 through Tabitha Taylor, the daughter, that Ms. Taylor 20 was this conscientious user of all medications or that 21 she had been trained to administer them safely. 22 23 24 25 That, in my mind, would open the door to a lot of her past. THE COURT: they understand that. Golkow Technologies, Inc. I think, generally speaking, If they open the door, you are Page 118 August 31, 2015 1 2 going to be able to come in. MR. MAYES: Well, they've moved to exclude 3 it, and they've already done that in their pleadings. 4 They've already noted that she is responsible when she 5 took her medication. 6 say that they would continue to make that point. 7 That's the reason I just would This stuff about the stealing the Weed 8 Eater and gambling, we've already conceded in our 9 pleading that we don't believe that those are fair game 10 11 in any respect. THE COURT: I'm going to grant the motion. 12 But if plaintiffs raise issues that are fair game for 13 countering, then they're going to be countered. 14 15 MR. HORN: If there is an issue that is a close call, we'll air it out with Your Honor. 16 THE COURT: 17 Exclude any reference to Mrs. Taylor's use All right. Motion granted. 18 of alcohol, tobacco, aspirin, prescription drugs, or 19 her alleged addictive personality. 20 to grant that. 21 22 23 Again, I'm inclined Tell me why, defense, why I shouldn't. MR. MAYES: It would be the same argument that I just made. THE COURT: Okay. All right. Exclude any 24 reference pertaining to potential risk factors that did 25 not cause decedent's injuries. Golkow Technologies, Inc. I think that's a big Page 119 August 31, 2015 1 discussion that we'll have on both of them together. 2 So I'm going to pass over that now until after our 3 break. 4 Exclude any reference or inference that 5 Mrs. Taylor was depressed or suicidal before her acute 6 liver failure. 7 8 What do we have? Do we have anything on that defense that's worth pursuing? 9 MR. MAYES: Not entirely. It would be 10 along the same lines, Your Honor, if they were to 11 attempt to put into evidence that she was a 12 life-loving -- and, you know, never had any problems, 13 and you know, wanted to live -- it's just not 14 consistent with her history. 15 depression for a number of years. 16 17 THE COURT: She was treated for Well, I am going to grant the motion. 18 So when we talk about Jackson, because we 19 have to talk about risk factors, we'll talk about that 20 all together. 21 going to get that issue covered in the next five 22 minutes. 23 And then I can -- it's a few minutes before 12. 24 25 I don't view -- you know, we're not I think everybody can use a bathroom break. You choose. Is that okay? 12:20, 12:30? Let's do 12:30. If we resume at 12:30, we're going to Golkow Technologies, Inc. Page 120 August 31, 2015 1 get this done today. 2 MR. HORN: One brief housekeeping matter. 3 I have to do it now, because I have to make a phone 4 call about this. 5 guidance from the Court, Judge. 6 We're actually asking for some I had a brief conversation with defense 7 counsel last week about the outstanding trial 8 preservation depositions for the treaters in the Taylor 9 case. We've been trying to schedule those. It's been 10 very difficult, because there are some hospital offices 11 that have made it very hard to do it. 12 the process of nailing down some dates. 13 Your Honor's ruling about Jackson being the selection 14 case. 15 whether or not those depositions should still go 16 forward. 17 would -- We received One thing we started talking about last week is At first, my instinct was they probably 18 THE COURT: 19 MR. HORN: 20 THE COURT: 21 We're finally in We'll know Tuesday, right? Maybe today -You'll know today or tomorrow; you're going to give us for certain, right? 22 MR. HORN: The only reason I'm raising it, 23 Your Honor, is I have noticed that Your Honor's 24 practice in everything has been to keep both cases on 25 track. Golkow Technologies, Inc. Page 121 August 31, 2015 1 THE COURT: 2 MR. HORN: I do. Without Your Honor's permission, 3 I certainly didn't want to cancel those depositions. 4 We have doctors who are getting us dates. 5 THE COURT: 6 MR. TISI: Yeah. 7 MR. HORN: I don't want to misstate their You do have them set up? 8 position. 9 available the end of this week and, I think, the end of We finally got dates from them. 10 next week. 11 dates with defense counsel. 12 rulings. 13 holding pattern. 14 They are I was in the process of nailing down the We got Your Honor's We kind of went into a little bit of a I guess we have two choices. We can -- 15 we're happy to go forward with them as soon as we lock 16 down dates with defense counsel, keep all the trials on 17 track. 18 I just think -- in the instance that 19 Jackson settled or something happened to it, I didn't 20 know if Your Honor would be displeased that we had 21 not -- 22 23 24 25 THE COURT: Yeah, I would be. keep both cases on track. MR. HORN: I want to I really do. That's why we wanted to ask for some guidance. Golkow Technologies, Inc. Page 122 August 31, 2015 1 THE COURT: Sure. There's ample resources 2 in your law firms to make sure that those depositions 3 get taken. 4 find out later that Jackson has settled, I want to go 5 right to Taylor. 6 I don't want to lose any momentum. MR. MAYES: If I The only thing I would add, 7 Your Honor, is we were made aware by Your Honor back in 8 July that both cases need to be prepared to be tried. 9 THE COURT: Sure. 10 MR. MAYES: We asked Mr. Horn on July 15th Yeah. 11 to get dates from these doctors, which I would add are 12 doctors that have already been deposed in the 13 litigation that they want to now re-depose. 14 "Give us the dates. 15 scheduled." 16 haven't been provided to us. 17 18 25 They still I really -- my guidance is I MR. HORN: And we'll get these done, Your MR. MAYES: My suggestion would be to use Honor. the depositions that have already been taken. 23 24 The dates were never provided. want them to go forward. 21 22 We'll see about getting them THE COURT: 19 20 We said, THE COURT: They may reconsider. Who knows? MR. KOTT: Golkow Technologies, Inc. And that's why I stood up, Your Page 123 August 31, 2015 1 Honor. 2 And I'm using that as a term of art. Because I'm -- the doctors are unavailable. 3 I'm unaware if a fact witness -- and these 4 are fact witnesses -- is deposed out of state and he's 5 unavailable, the party who took that deposition now 6 goes and gets to do a second deposition. 7 position, under the rules of court, and I'm now 8 referring to the court rules, but also under the rules 9 of evidence, that they don't get a second deposition. 10 MR. HORN: It's my Just to clarify, they are not 11 unavailable. 12 to say it wasn't a hassle doing it, because it was, and 13 that's why it took so long. 14 unavailable. 15 it again. I'm not going But they're not They're willing to do it. We want to do There's no obstacle to doing it -- 16 17 They are willing to do it. THE COURT: It seems like you want to do a second deposition? 18 MR. HORN: 19 deposition, Your Honor. 20 plaintiffs. 21 defense counsel. The first one was a discovery 22 There was no direct done by It was not done in sort of a formal way by THE COURT: Then I would -- no, Mr. Kott, I 23 think they are entitled to do their own de bene esse 24 deposition for submission of testimony at the time of 25 trial. Golkow Technologies, Inc. Page 124 August 31, 2015 1 2 MR. KOTT: the first deposition and they noticed it. 3 MR. HORN: 4 MR. MAYES: 5 MR. HORN: THE COURT: It's true as to We did not notice it. And we And that is an important fact that we ought to resolve. 10 11 Yes, it is. want to go forward today. 8 9 That's not true. Dr. Gebetsberger -- 6 7 Just so we're clear, they took MR. KOTT: We'll let you know, because on the ones that they questioned first -- 12 THE COURT: If you called the deposition, 13 and you still -- I'd like to see -- it's important, 14 just to be -- sprinkle this into your conversations. 15 It is important to me, if you think this witness has to 16 be called, I'd rather see him in video, than somebody 17 stand up and reading testimony. 18 MR. HORN: 19 THE COURT: 20 MR. HORN: That's our view as well, Your MR. MAYES: The plaintiff chose not to 21 videotape. 24 25 Rather see that, yeah. Honor. 22 23 You would rather see that done? I didn't have control over that. THE COURT: Okay. Let's get that answered first. Golkow Technologies, Inc. Page 125 August 31, 2015 1 See you in half an hour. 2 THE CLERK: 3 (Short break.) 4 5 6 7 8 9 10 11 Court recessed. THE CLERK: Please be seated but come to THE COURT: Mr. Kott, you are taking order. careful notes, right, for this order? MR. KOTT: reporter here. I'm so glad we have a court I will confess on the record, one or two of the motions I'm looking for, where are they? THE COURT: Do you want to go back over 12 them right now? 13 saying, granted, denied, granted in part, denied in 14 part, neither granted nor denied, denied without 15 prejudice, granted without prejudice. I think when we break I'm either 16 I think I've been pretty precise on that. 17 MR. KOTT: 18 think the Court knows, I don't submit things under -- 19 THE COURT: 20 MR. KOTT: 21 22 And what I will do -- and I I know. I'll do this here, is send a copy to Mr. Horn. THE COURT: Okay. Let's go to Jackson. 23 Let me go through the ones I have here. 24 why I would change anything. 25 I don't see Exclude reference to verdicts of adverse Golkow Technologies, Inc. Page 126 August 31, 2015 1 impacts on the pharmacy industry, ability to get 2 medications, stock value, and publicly traded 3 corporation, et cetera. 4 5 6 I've already said granted. MR. MILLING: That's omnibus, identical. We can incorporate the rulings. THE COURT: Yeah, I'm going to say we 7 incorporate the ruling until we get down, again -- 8 because this is case-particular, plaintiff-particular, 9 exclude current and former employee character evidence. 10 Is that an issue here? 11 The ruling is the same as on Taylor. 12 So there's nine precede that. But looking at Jackson, are we talking 13 about any employee evidence we need to be concerned 14 about for character? I'm asking. I don't know. 15 MR. MILLING: 16 THE COURT: Defense? 17 MR. MAYES: They were concerned that we I don't think so. 18 were going to bring up her chronic absence from work. 19 That's not something I -- 20 THE COURT: That's the flavor I got, 21 something about her work history. 22 MR. HORN: That was our motion. 23 was it's irrelevant to the case. 24 prejudicial to hear that she -- 25 THE COURT: Golkow Technologies, Inc. Our view It would be I think it is too. But Page 127 August 31, 2015 1 Mr. Mayes is saying we're not going to worry about it. 2 3 MR. HORN: If they're not, then I'll sit down and be quiet. 4 MR. MAYES: 5 political affiliation. 6 that. 7 cocaine use. 8 in the Jackson case. 9 The ones I remember -- one was We don't intend to get into The other one was absences from work. One was We don't intend to get into any of those Now, they do have a -- I think the big one 10 in Jackson that we might want to discuss is, they've 11 moved to exclude potential risk factors that they claim 12 are -- 13 THE COURT: 14 Okay. 15 MR. MAYES: 16 17 18 19 20 We're going to get to that. That was within the same motion, is what I'm saying. THE COURT: And we have to discuss risk factors as to both cases. Exclude current and former employee character evidence is granted. 21 Exclude any mention that design defect, 22 failure-to-warn laws pressured defendants to dilute 23 their invalidated warnings. 24 25 Again, same as I ruled before, which is -I'm looking at my notes here -- neither granted nor Golkow Technologies, Inc. Page 128 August 31, 2015 1 denied on that one. 2 Exclude any mention that state tort laws 3 undercut FDA's mission. 4 withdrawn. 5 I think you said that was Which one -MR. MILLING: No. 6 that one. 7 of motions that had to do with. I think you ruled on That was -- again, that goes to the grouping 8 THE COURT: 9 MR. MILLING: 10 Which ones did you withdraw? That a verdict would impact the FDA, pretrial publicity. 11 THE COURT: 12 MR. MILLING: 13 THE COURT: Pardon me? Pretrial publicity. Pretrial publicity, you're 14 withdrawing because they're going to make a 15 representation. 16 or go too fast here. 17 18 I don't want to get ahead of ourselves Exclude any mention that state law undercuts FDA's mission. 19 MR. MAYES: 20 MR. MILLING: 21 THE COURT: 22 Exclude any mention that plaintiffs want 23 You granted that one earlier. You granted it. That's granted. Tylenol removed from the market. 24 MR. MAYES: 25 MR. MILLING: Golkow Technologies, Inc. That was withdrawn. That was withdrawn. Page 129 August 31, 2015 1 THE COURT: Okay. Exclude any evidence of 2 defendants' reputation and good acts. 3 that's not an issue. 4 be talking about it. 5 6 It's granted. Okay. We're not going to Exclude any evidence of settlement negotiations. 7 Granted. Attendants should be precluded from 8 increasing pretrial publicity. 9 representation that there won't be any. 10 neither granted nor denied. 12 one. 14 15 16 17 Again, we've got their Again, court designations, we're -- that's 11 13 Again, MR. MILLING: I'll deal with it one by That's the stuffing of the turkey and proof in the pudding. THE COURT: in the pudding. Stuffing the turkey and proof You got it. Exclude evidence, arguments that defendants 18 were precluded from changing the label. 19 that -- we've had that conversation. 20 without prejudice. 21 And I think that's a correct way to approach it. 22 We've had That's denied At least that's what my notes say. Exclude any mention that compliance with 23 FDA regulation absolves liability. 24 liability, but we also know that FDA is a big dog that 25 we're going to have to talk about. Golkow Technologies, Inc. It doesn't absolve Page 130 August 31, 2015 1 So for purposes of ruling, it's denied 2 without prejudice, which means we will revisit it. 3 Any mention that the manufacturer does not 4 have the ultimate responsibility. 5 They do have the ultimate responsibility. 6 That's granted. Again, but it's granted without prejudice, 7 subject to them, you know, being able to argue their 8 position. 9 Exclude any mention of nonliability because 10 Tylenol was approved by the FDA. 11 granted without prejudice. Okay. Again, that's 12 When I grant something without prejudice, 13 then the burden of persuasion is on the other side or 14 vice versa, deny without prejudice. 15 16 17 Exclude any argument that Tylenol is GRASE. We've already addressed that. That motion is denied. Exclude any evidence of personal use of 18 Tylenol by any party, witness, or counsel. 19 motion is granted. 20 We know that. 21 But, again, it may come into play. Strike Sherrie -- talking about striking 22 the testimony of Sherrie Cathcart. 23 part, denied in part. 24 MR. TISI: 25 Again, that That's granted in Judge, on that one, I did not mark that chart that I gave you, but I assume you have Golkow Technologies, Inc. Page 131 August 31, 2015 1 it. 2 3 THE COURT: Yeah, I have it. it back? 4 MR. TISI: No, the chart -- no, no. 5 Judge Higbee's list. 6 which kind of grouped the testimony. 7 make sure -- 8 9 THE COURT: 11 THE COURT: 14 15 16 17 I just wanted to Yeah, yeah, I have that. When you said chart -MR. TISI: 13 That's I gave you like a spreadsheet 10 12 Do you need I'm sorry. Yeah. May I approach? I've attached it to the deposition. MR. TISI: Yeah, that's it. just want to make sure you have it. THE COURT: Correct. I Thank you. I have it, and I will be looking at it before we discuss that issue again. Okay. Exclude any reference to risk of 18 adverse events for medications other than 19 acetaminophen. 20 prejudice, because they'll have the opportunity to get 21 into that -- neither grant nor deny is how I'm 22 approaching that. 23 And, again, that is granted without Preclude the inference that there are a 24 lack of randomized controls. 25 talking about that. Golkow Technologies, Inc. We spent a lot of time That motion is denied. Page 132 August 31, 2015 1 Okay. Jackson-specific omnibus, exclude 2 any reference or inference relating to plaintiffs' 3 experimentation with alcohol, tobacco, or illicit 4 drugs. 5 Talk to me about this plaintiff. 6 MR. MILLING: 7 didn't intend to bring it up. 8 9 Mr. Mayes just said they MR. MAYES: With the exception of the alcohol, specifically her admitted alcohol consumption 10 on the first date of her applicable or pertinent 11 Tylenol ingestion. 12 13 That's why we disagree. THE COURT: Four glasses. She drank a bottle of wine. Maybe it's not a bottle. 14 MR. MAYES: 15 MR. MILLING: It is in my eyes. First, Your Honor, I'll let 16 Mr. Tisi address the design defect aspect because 17 that's all we're dealing with now. 18 to the label, the label only says, "Consult your doctor 19 if you drink three or more glasses of alcohol every 20 day." But as it relates 21 So taking -- drinking four glasses of wine 22 and then taking Tylenol is not relevant to any conduct 23 in this case. 24 25 MR. HORN: And to your point, Your Honor -- and I'll let Mr. Tisi respond -- there's no theory Golkow Technologies, Inc. Page 133 August 31, 2015 1 under which we are aware this would be relevant to 2 anything. 3 this is some sort of element they're relying on that's 4 probative to some -- 5 6 7 I'm unaware of the defense experts saying THE COURT: It doesn't seem like it from my reading of the expert's deposition. MR. HORN: So at that point, all it is, is 8 prejudicial without any probatives, and we would argue 9 on the 403(c) that this would -- 10 THE COURT: This motion is granted. 11 MR. MAYES: Your Honor, if I could make one 12 comment in there. 13 boils down to a design defect claim, if I understand 14 the plaintiffs' position, the defect that they claim 15 rendered it defectively designed was the label of 16 instructions specific to dose? 17 the same page there? 18 lowered the dose, right? 19 MR. MILLING: If the case is now, the Jackson case Is that -- are we on They are saying we should have No. There are multiple 20 defects, but it essentially boils down to the fact that 21 this drug has the capacity to cause a range of DILIs, 22 from low DILI to death, at far lower doses than people 23 are aware of. 24 25 MR. MAYES: And the point I would make on that, Your Honor -- Golkow Technologies, Inc. Page 134 August 31, 2015 1 MR. MILLING: 2 MR. MAYES: And outweighs the benefit. -- is there's no indication 3 that Ms. Jackson -- first of all, she readily admits 4 she didn't read the label. 5 direct violation of the "do not use this product if you 6 consume three or more alcoholic beverages daily while 7 taking this product," which would include the first day 8 that she took it. 9 whether or not the design defect they claim, that being 10 11 12 13 So the alcohol use is in So I would say it does come in on the label dosing, caused her injury. THE COURT: Isn't that going to depend upon whatever proofs they submit? MR. TISI: Yeah, I think this kind of 14 dovetails into the larger question of what's left in 15 the case after your ruling of last week. 16 this is a design defect case under -- I spent the 17 weekend studying design defect law under New Jersey, 18 and it's very clear that the design defect, under the 19 design defect law, the -- what she did and did not do 20 is not relevant or is of very marginal relevance if 21 they meet certain hurdles. 22 And because The question in this case is whether or 23 not, when the drug was on the shelf, when she bought 24 it, whether the risk utility of Extra Strength Tylenol 25 was -- the jury will have to decide whether or not that Golkow Technologies, Inc. Page 135 August 31, 2015 1 is -- passes the risk-utility test. 2 objective test. 3 in the Johansen v. Makita case, 128 N.J. 86, the 4 plaintiff's actions or nonactions do not bear on that 5 question of design defect under the risk-utility 6 analysis. 7 That is an And the objective test, and, in fact, And so, to me, at least at this point, 8 there are some defenses to that product misuse, those 9 kinds of things, but whether she took alcohol later on 10 down the stream is irrelevant. 11 from the Makita case, "The risk-utility analysis based 12 on the premise that the product is defective, if it's 13 dangerous when marketed, the postmarketing conduct of 14 one plaintiff cannot inform that determination." 15 And I would just quote So what her action is down the stream 16 doesn't really bear on the risk-utility analysis of the 17 drug when it's marketed. 18 New Jersey. 19 glasses of wine does not bear on that question. 20 So that's the test of And, frankly, whether she took a couple of MR. KOTT: One of the plaintiffs' design 21 defects is, and I'll just address one, is the dosing. 22 Plaintiff says the product is defectively designed 23 because it allowed too large a dose. 24 that claim, plaintiff is going to have to prove a 25 defect but also causation; that had we had that Golkow Technologies, Inc. To prevail on Page 136 August 31, 2015 1 different dosing, that she would have followed that 2 instruction and she would not have been injured. 3 So Mr. Tisi cites Johansen, which just 4 deals with the product defect. 5 that the plaintiff has to prove under that cause of 6 action, which is causation. 7 We have another element Presumably Ms. Jackson is going to get on 8 the stand -- we may object to it -- but she's going to 9 say, "Oh, my, if somebody had only told me 3 grams 10 instead of 4 grams, I would have done something 11 differently," because that's what she needs to prove on 12 causation under design defect. 13 the liquor comes into the case, because she didn't 14 follow the warning she got; and, therefore, the jury 15 can conclude that she would not, despite her 16 self-serving -- and I know all testimony is 17 self-serving. 18 self-serving testimony that "Had I been told 3 grams 19 instead of 4, I would have done something differently." 20 We have a right to test that and say, "Hold on. 21 didn't follow the very warnings we gave her. 22 Therefore, you can disbelieve her self-serving 23 testimony." 24 25 That's exactly where I use it here on purpose -- despite her MR. TISI: She And I think a really careful look on the New Jersey law on this is really important. Golkow Technologies, Inc. Page 137 August 31, 2015 1 The test is, of course, an objective test. 2 I'm reading directly from the jury instruction. 3 foreseeable uses and awareness of the dangers inherent 4 of the product and their unavoidability, because of the 5 general public's knowledge of the obvious condition of 6 the existence of suitable warnings and instructions." 7 "The So the point -- the point of the Makita 8 case and every other case that's done, that has 9 addressed this issue, courts have fallen into the trap 10 in a design defect case of trying to engraft 11 case-specific issues on the design defect module. 12 the Court, whether it's the Feldman case or the Makita 13 case, they have repeatedly come back to the question of 14 whether or not it -- there's no question in this -- I 15 just interrupted myself. 16 There is no question, in this case, 17 acetaminophen caused this woman's almost two-week 18 hospitalization. 19 And There's no question about that. The question really in this case is whether 20 or not the risks outweighed the benefit to the average 21 objective consumer. 22 case-specific issues into that inquiry. 23 MR. KOTT: And we cannot start injecting Except for the Supreme Court in 24 the appellate division, and I'm going to make an 25 approximation, at least five cases on design defect Golkow Technologies, Inc. Page 138 August 31, 2015 1 have said what the plaintiff did may not be admissible 2 on whether or not it's defective. 3 five -- I think actually five reported cases, they've 4 said it's admissible on causation. 5 argument -- I've moved beyond product defect, which 6 Mr. Tisi keeps coming back to. 7 and, by the way, I'm going to vary from my friend 8 Mr. Mayes. 9 The cocaine use may be relevant on the anticipated But in three to And that's what our I'm talking about -- We'll have to have a discussion about this. 10 self-serving testimony. 11 issues. 12 violated the very warning she got, she received, is 13 relevant on proximate cause. 14 defect. I realize there's other But, clearly, on the alcohol, that she 15 MR. TISI: I'm not talking about I'm going to the Badignoli (ph) 16 case. 17 not have been allowed to use the plaintiff's conduct in 18 determining whether or not the car was defectively 19 designed." 20 It says, "The Court ruled that the jury should And the end of the day, it comes down to an 21 issue of comparative fault, which is, in this 22 jurisdiction, we have some of that in the design defect 23 case. 24 last week, foreseeable misuse is no defense in a 25 design. But as Your Honor found in your findings of fact And I think you were aware and you noticed -- Golkow Technologies, Inc. Page 139 August 31, 2015 1 2 THE COURT: But it may very well depend upon what she testifies to. 3 4 Well, it's not. What I'm do is granting your motion without prejudice. We may revisit this. 5 MR. TISI: 6 THE COURT: I don't know. Thank you. Exclude character evidence. 7 We're not going to get into that, are we? 8 granted. 9 Exclude any reference to previous 10 litigation. 11 relevant here? Is there any previous litigation that's 12 MR. MAYES: 13 MR. HORN: 14 That's No, Judge. I'm assuming they're not going to -- there was a car accident years and years ago. 15 MR. MAYES: We agree. 16 THE COURT: Granted. 17 Exclude any reference to plaintiffs' 18 reprimand for chronic absence. 19 there, right? You're not going to go 20 MR. MAYES: No, Your Honor. 21 THE COURT: Exclude any reference to 22 political affiliation. 23 that? We're not going to get into 24 MR. MAYES: No, sir. 25 THE COURT: Granted. Golkow Technologies, Inc. Page 140 August 31, 2015 1 Exclude any reference to potential risk 2 factors. 3 it applies to both cases. 4 has the burden of proof on both these motions, I'll let 5 the plaintiff go first, and then we'll hear from the 6 defendants. 7 8 Now, we need to talk about that issue because MR. TISI: here -- I'm sorry. 9 And because the plaintiff The last time when we were We're talking about risk factors. THE COURT: Yeah, risk factors. Why should 10 the jury -- Mr. Jackson, are you going to argue this 11 one? 12 MR. JACKSON: 13 MR. MAYES: What number motion is this? 14 THE COURT: Hold on. I'm unclear as to -- Let me look -- maybe 15 we're going to deal -- maybe we're going to get a 16 three-for, instead of a two-for. 17 MR. JACKSON: Defendants' 17 is motion to 18 exclude testimony regarding risk factors. 19 trying to be clear, are we talking about that or -- 20 THE COURT: Hold on. So I'm just I think we're talking 21 about the same thing. 22 one each under Taylor and Jackson, and then one by 23 the -- one by the -- well, it's -- we have four 24 motions. 25 by you, two by them. We basically have three motions, This is the fourth one. Golkow Technologies, Inc. I'm getting -- two Each side has raised a question. Page 141 August 31, 2015 1 You want to talk about risk factors. 2 about risk factors. 3 talk about risk factors first. 4 talk, and we'll go from there. 5 They want to talk You made the motion first. MR. TISI: You'll And then I'll let them All right. The lowest common -- 6 let's talk about the common claim in both cases, which 7 is design defect. 8 But let's put that aside for a moment. 9 One has a failure-to-warn component. When we were before you last year, we were 10 primarily discussing failure to warn. 11 design defect aspect of that case. 12 statement of the record to say that when we were all 13 together last year, the focus was what were the 14 warnings, and what did plaintiff do. 15 There was a I think it's a fair I want to move off of that, if we could, to 16 where we are today, which is in both cases, we have a 17 design defect case. 18 As I talked about last week and as I told 19 you on the weekend, really, trying to look at this 20 question, and both Taylor and Jackson will apply a 21 risk-utility analysis, whether it's under Oklahoma law 22 or New Jersey law. 23 different. 24 defect of the product. 25 There may be some nuances that are But primarily, the focus is on the design I'm going to refer the Court to the Golkow Technologies, Inc. Page 142 August 31, 2015 1 Johansen versus Makita case, 128 N.J. 86, 1992. 2 3 And that case makes two points that I think are relevant to this discussion. 4 Number one is that the entire risk-utility 5 analysis, the starting point for the jury's 6 deliberations in this case, is an objective test that 7 is governed by the class of users of the products, not 8 just the particular plaintiff. 9 of Extra Strength Tylenol is the general public. 10 isn't a diabetes drug. 11 THE COURT: 12 MR. TISI: The class of the users This That's a pretty broad class. It's a pretty broad class. It's 13 not just, for example, a diabetes drug where we look at 14 diabetics or heart medication that we look at people 15 with heart disease. 16 This is people who use OTC Tylenol. 17 that's the first part of the Makita case that's 18 important. 19 So The second part that's important is the 20 product liability law in New Jersey is premised on 21 the -- the premise of it is that the product is 22 dangerous when marketed. 23 So the post-marketing attributes of any 24 particular plaintiff cannot inform that determination 25 as to whether or not the product is defective as Golkow Technologies, Inc. Page 143 August 31, 2015 1 designed. Okay. 2 So to use a car example. 3 THE COURT: 4 for another issue. 5 factors. Okay. This sounds like an argument We are talking about the risk 6 MR. TISI: 7 THE COURT: It is. Which is alcohol, malnutrition, 8 fasting, all those things. 9 is, why do we want -- Plunkett gets into a lot of that, 10 and so does Blume. 11 I mean, I guess my question Why do we hear that testimony? MR. TISI: The reason you hear about it is 12 because Extra Strength Tylenol is marketed to all 13 comers. 14 may not be eating very well. 15 They're marketed to people who are sick and THE COURT: 16 alleging here? 17 well? 18 But is that what you're Your lady was sick and wasn't eating MR. TISI: No, Your Honor. That's not the 19 focus in the Johansen case. 20 under the risk-utility analysis, she is kind of like a 21 cork in the ocean. 22 THE COURT: 23 MR. TISI: The focus in the -- Ms. -- Go ahead. What is really important is 24 where does the wave start. 25 my analogy with the product, and the jury has to Golkow Technologies, Inc. And the wave starts, using Page 144 August 31, 2015 1 understand the entire risk profile and entire benefit 2 profile. 3 Let me give you an example. They are going 4 to bring in efficacy studies in this case because the 5 other side of the analysis is, how effective is it? 6 There are going to be dental pain studies. 7 going to be episiotomy studies. 8 studies of people with acute headaches, people with 9 osteoarthritis. 10 There are There are going to be Mrs. Taylor doesn't have any of those 11 conditions. 12 side of the equation. 13 hear -- the jury should hear, what are all the benefits 14 of this product to the average objective consumer? 15 But they all go in within the benefits So the jury is going to have to At the same time, the jury is going to have 16 to hear what are the potential risks. 17 risks are you can get it at 4 grams. 18 getting it are greater if you are malnourished. 19 They're greater if you have all these different risk 20 factors. The potential Your chances of 21 Because without that information, the jury 22 is going to be unable to render a verdict on the first 23 question in this case, which is, does the risk -- the 24 totality of the risks outweigh the totality of the 25 benefits? Golkow Technologies, Inc. Page 145 August 31, 2015 1 And that focus is on all comers. That's 2 why -- that's why it is very important in a design 3 defect case, whether it's under Oklahoma law or under 4 New Jersey law, it's almost like until you get to 5 Questions 2 and 3 on the jury instruction, the first 6 question is really not relevant to Ms. Jackson or 7 Ms. Taylor. 8 9 The first question is, is this product defective as designed? And that's -- I don't know how 10 to say it better than that, except as to say, it's all 11 the risks and all the benefits. 12 Tylenol -- under your ruling, the first question, it's 13 Extra Strength Tylenol is on trial in this case. 14 It's Extra Strength And it is the whole risk profile and the 15 whole benefit profile. 16 company and what everybody else, the American 17 Association for Liver Disease, what they're all doing. 18 It is what the FDA and what the They are not looking at any particular 19 plaintiff. 20 of the drug, pro and con. 21 motions -- there are four, I think you said. 22 four-for here. 23 24 25 They're looking at the overall attributes That's why for all of these We have a THE COURT: You each have filed motions in MR. TISI: The general framework -- and we this case. Golkow Technologies, Inc. Page 146 August 31, 2015 1 can talk about things individually -- but the general 2 framework of the law, at least as I've spent the time 3 reading this weekend, is the focus is on the product, 4 objectively without any reference to the plaintiff 5 specifically, until you get down the road to her 6 injuries and proximate cause and whatever defenses 7 there are. 8 9 10 But the first question is really focused on the totality of the benefits and the totality of the risks. 11 THE COURT: 12 MR. JACKSON: Mr. Jackson. Your Honor, I have to 13 respectfully disagree with plaintiffs' effort to 14 disengage the defect issue from any facts involving the 15 plaintiff. 16 I think it is clear under the law that the 17 defect that's alleged has to be a defect that caused 18 harm to the plaintiff. 19 to Mr. Tisi, to think of a good metaphor, or analogy, 20 rather. 21 liability case about a allegedly defective car that's 22 gone over the cliff because the brakes failed. 23 And I've struggled, as I listen And I'm thinking of a car case, a product The plaintiff in that case would allege 24 that the car was defectively designed because the 25 brakes didn't work properly. Golkow Technologies, Inc. Page 147 August 31, 2015 1 How would it be relevant in that case to 2 offer evidence that the catalytic converter was 3 defective as well? 4 the catalytic converter didn't work well. 5 has nothing to do with the injury that's being 6 complained of by a particular plaintiff, how in the 7 world is it relevant to that plaintiff's case? 8 9 It may be a, quote, defect in that But if it It's not an abstract question, Your Honor. It's not something that we're just here in a sort of 10 ivory tower to assess whether the jury thinks the 11 product was defective as it relates to malnourished 12 people or as it relates to heavy drinkers or as it 13 relates to people with viruses or whatever the various 14 risk factors are. 15 That's not what this jury is going to be 16 asked to do. 17 is to assess whether the product was defective as used 18 by this plaintiff and whether the defect caused this 19 plaintiff's injury. 20 What this jury is going to be asked to do And when this plaintiff, or these 21 plaintiffs, had none of these risk factors -- they 22 weren't alcoholics. 23 weren't fasting -- those risk factors are not relevant. 24 25 They weren't malnourished. They Furthermore, even if there were some marginal merit to what Mr. Tisi says, the risk of Golkow Technologies, Inc. Page 148 August 31, 2015 1 confusing the jury with this kind of evidence would be 2 very, very high, because we would then be talking about 3 all of these disputes. 4 And Your Honor knows that we don't agree 5 that the proof is there for malnutrition or fasting or 6 alcohol. 7 and we can spend a lot of time in this trial arguing 8 about whether or not the scientific evidence actually 9 supports any of these risk factors. 10 We have a lot of things to say about that, And I think that is a very -- A, wastes a 11 lot of our time; and B, would be very confusing to the 12 jury ultimately hearing a lot of evidence that has 13 nothing to do with the plaintiff who is before the 14 Court. 15 And we've submitted in our brief. There's 16 some cases that we've cited to, the Barker case out of 17 the Third Circuit where it's been tractors and whether 18 you should -- if a case doesn't involve a rollover, it 19 is -- was found to be an error to admit a bunch of 20 evidence about rollovers. 21 my car analogy, I would submit, that you just don't 22 open it up for a sort of abstract analysis of the 23 product and whether it's defective in the way that 24 Mr. Tisi has just suggested. 25 THE COURT: Golkow Technologies, Inc. And it's the same thing as Okay. One moment. The blue Page 149 August 31, 2015 1 man is going to go out. 2 the blue man back on. 3 (Brief interruption.) 4 THE COURT: 5 MR. TISI: 6 Mr. Tisi. Yeah, I would like to adopt the -- 7 8 And then we're going to put THE COURT: got to be on. 9 Pardon me. The blue man has I went too quick. MR. TISI: 10 THE COURT: 11 MR. TISI: That's okay. Here we go. I'm going to adopt the car 12 analogy and see if I can work with it to really 13 illustrate the point of New Jersey law. 14 When you design a car with an accelerator 15 and a brake, you have to anticipate all of the kinds of 16 people who will use that car. 17 that a child may get in the front seat of the car and 18 not be able to -- may reach the accelerator, but not 19 the brake. 20 may use the car. 21 car may be used in the mud that will allow it to get it 22 up into the brake and the accelerator. 23 You would anticipate You might anticipate that a seven-foot man You may have to anticipate that that The point is that you have to take all 24 comers. And in those cases, you have to look at all 25 comers. And the fact that a particular plaintiff in Golkow Technologies, Inc. Page 150 August 31, 2015 1 one of those cases -- and the case law is really clear 2 on this -- was a seven-year-old person, or a large 3 person, or was -- I think there are cases involving 4 snow equipment, snow-removal equipment, that talk about 5 this. 6 designed, that being the brakes and the accelerator. You really look at, is the product defective as 7 Here, the issue is acute -- is acute liver 8 failure working all the way down to elevated 9 transaminase. It's the spectrum of liver disease. 10 We're not talking about heart disease; we're not 11 talking about anything else. 12 correct. So the analogy is not So that's number one. 13 Number two is -- I don't know whether or 14 not Mr. Jackson had an opportunity to really look at 15 the jury instructions on this point, but I would refer 16 you to the jury instructions, specifically on the 17 risk-utility analysis in Charge 5.40 D-3. And the 18 six-part test of that specifically talks about, it 19 gives five factors -- excuse me -- six factors, none of 20 which is specific to the plaintiff. 21 In fact, the reason for that is that the 22 courts -- the highest courts of this jurisdiction, the 23 appellate division and Supreme Court, have been very 24 clear that in the risk-utility analysis that focuses on 25 the product. Let me give you an example. Golkow Technologies, Inc. Page 151 August 31, 2015 1 Factor Number 1, the usefulness and benefit 2 of the product as it was designed to the user and the 3 public as a whole. 4 5 Was there a need for this product to be designed in a specific way? 6 That's Factor Number 1. Factor Number 2 is the safety aspects of 7 the product, that is, the likelihood or risk that the 8 product as designed would cause injury and that the 9 probable seriousness of that injury which could have or 10 should have been anticipated through the use of the 11 product. 12 range of injuries on the risk side of the table. 13 14 Was there a substitute designed for this product that was feasible and practicable? 15 16 Again, an objective standard looking at the Number 4, the ability for the defendant to eliminate the product without impairing its usefulness. 17 And 5, the ability of the foreseeable 18 users, again an objective test, all comers, to avoid 19 the danger by exercise of care of use of the product. 20 And the sixth factor, which is the 21 foreseeable users' awareness of the dangers inherent in 22 the product and that is an unavoidably unsafe aspect of 23 it. 24 25 The point of it is, if you look at the law as it stands in New Jersey -- and the reason why I'm Golkow Technologies, Inc. Page 152 August 31, 2015 1 really emphasizing this is because trial courts have 2 erred and have been corrected by the appellate 3 courts -- when they inject the specific facts of the 4 specific plaintiff into this analysis and the courts 5 have repeatedly said you cannot do that and have 6 reversed trial judges for doing that. 7 think anybody here is interested in having Your Honor 8 questioned on appeal. 9 THE COURT: And I don't The point here is -At this stage, it doesn't 10 concern me. 11 division decisions is something to learn from. 12 Sometimes I learn I did it right. 13 did it wrong. 14 Educational opportunity for me. How I view -- how I view appellate Sometimes I learn I I don't worry about it at all. 15 And I'm sitting here listening to you, and 16 I ask myself, do you take on the burden of proving too 17 much? 18 you can prove? 19 Do you take on the burden of proving more than MR. TISI: And ultimately that is a 20 question that obviously goes to the issue of trial 21 strategy for us. 22 not, if I am a juror and this is something that's 23 really important to me, if I'm sitting in the jury box, 24 I am -- one of the things I want to know about, a 25 defect of design, is whether or not -- not whether so But the question about whether or Golkow Technologies, Inc. Page 153 August 31, 2015 1 much I in particular, given my particular attributes as 2 a guy who is losing his hair, is going to have a 3 particular reaction to a drug. 4 The question is whether or not the 5 foresee -- whether or not the actual risk profile of 6 the drug, okay, the entire risk profile, and the entire 7 benefit profile is something that makes this product 8 unavoidably unsafe. 9 Let's be concrete here. The difference 10 between Extra Strength Tylenol, 500 milligrams, and 11 325 milligrams, regular strength Tylenol, is 12 175 milligrams. 13 you look at the benefits side of the equation, there is 14 almost -- that 98 percent of the people who take 15 regular strength Tylenol get the same relief as they 16 get with Extra Strength Tylenol. 17 going to hear there is an increased risk, and that 18 increased risk is multifactorial. 19 The jury is going to hear that when Yet they are also It is, you may not be eating a couple of 20 days because you've got the stomach flu. 21 not -- you may go to a party and have a couple of 22 drinks. 23 don't know anything about. 24 25 You may You may have genetic predisposition that we The point of the matter is, I don't think a jury in this case is going to like or understand the Golkow Technologies, Inc. Page 154 August 31, 2015 1 fact that they can get the same benefit by taking a 2 drug at a lower dose, yet take on additional risk at a 3 higher dose for factors we know, factors we suspect, 4 and factors we don't even know. 5 that responsibility? Why would anybody take 6 Again, under the law, whether we choose to 7 prove it up or not as part of our proofs, maybe that's 8 tactical. Maybe you're right. 9 too much. But under the law, we have a right to make 10 that argument. 11 benefits and all the risks. 12 Maybe we are taking on And the argument would include all the So I hear Mr. Jackson. I think we're 13 thinking about failure to warn, and so maybe in that 14 context it might be a closer question. 15 there is. 16 a closed question on this, at least not according to my 17 reading of the cases. 18 MR. KOTT: I don't think But certainly, under design defect, it's not I don't fault Mr. Tisi for not 19 being fully familiar with our design defect. 20 look at the model jury charge, it does instruct the 21 Court to not -- to use it in the context of the case 22 before it. 23 specifically to the risk-utility factors that are 24 inapplicable should not be instructed. 25 If you And what I'm referring to is, refers I'm not saying that 100 percent rebuts what Golkow Technologies, Inc. Page 155 August 31, 2015 1 Mr. Tisi says. 2 Judge, you have a case before you with concrete 3 allegations," meaning whatever they are, and coming 4 back -- and I do have a lot of experience in trying 5 design defect cases. 6 example than Mr. Jackson did. 7 But I think that's saying, "Look, Trial Let me give you a little broader Riding lawn mowers, you have three primary 8 accident examples: 9 and hits the blade; thrown object; and then a fire from 10 11 blade contact, somebody falls off the gasoline. And if we have somebody falls off and says, 12 "I hit the blade, and the guarding is inadequate," 13 under the model jury charge and under our law, we don't 14 get into whether the product is defectively designed as 15 it relates to thrown objects or risk of gasoline fire. 16 We don't do that because the model jury charge says -- 17 and this is all throughout our law. 18 Supreme Court said a bunch of times, "We're going to 19 give you the model jury charges, but you need to factor 20 them into the case that you have." 21 bunch of times. 22 model jury charge. 23 24 25 Remember, the They've said that a In fact, they wrote, actually, in the The other reasons are what Mr. Jackson said, which is they are prejudicial. But more than that, we have an unbelievable Golkow Technologies, Inc. Page 156 August 31, 2015 1 undue consumption of time. 2 cutoff date to finish the trial, which is the second or 3 third week of October -- 4 5 THE COURT: The Court has given us a And we're going to talk about that issue. 6 Go ahead. 7 MR. KOTT: If we're all in on all issues, 8 Judge -- there are 18 criticisms they have, and only 9 one of them is relevant to Jackson or Taylor; maybe two 10 are -- we're going to be here for months and months. 11 My argument is not primarily 403. I do get 12 there. 13 instructed in case law, tailor your jury charge to the 14 facts of the case you have. 15 specifically in the model jury charge under design 16 defect. 17 But my argument is the Supreme Court has MR. TISI: They've done it Judge, first of all, I 18 appreciate counsel's schooling on this, but I actually 19 have read these pretty carefully. 20 There are allegations, for example, that 21 because of depletion of glutathione, that patients -- 22 because glutathione expresses itself in the lungs, that 23 this is a potential cause for asthma in children. 24 Okay. 25 That would be under Mr. Kott's analogy. Golkow Technologies, Inc. Page 157 August 31, 2015 1 That would not come in, because we're not looking at 2 that issue in this case. 3 acute liver injury. 4 5 We are looking at liver -- And it's a spectrum. What does a jury expect of what they know about liver injury? 6 It would be salami-slicing this case to the 7 maximum to have to say that we can only prove our case 8 very specific to that injury. 9 example. Let me give you an Let's look at the efficacy side of it. If 10 Mr. Kott was correct, they can't use episiotomy 11 studies. 12 efficacy. 13 efficacy side to demonstrate that this is a wonderful 14 product. 15 They can't use dental pain studies on They can't use any of those studies on the You would only be able to use an efficacy 16 study that was specific to the individual plaintiff. 17 That's not what -- that's not what the law says. 18 I would never -- I would never tell 19 Mr. Kott that he could not look at the efficacy side of 20 the entire spectrum of the good effects of 21 acetaminophen. 22 Under the law, again, looking at what a 23 reasonable, objective consumer expects of a product on 24 the liver issue specifically, the jury needs to 25 understand that nobody understands that they could take Golkow Technologies, Inc. Page 158 August 31, 2015 1 acetaminophen on one day and be perfectly fine, take it 2 for four days and not be perfectly fine. 3 of the risk utility of this drug. 4 That is part And so I guess I just want to really kind 5 of wind this down. 6 and I really appreciate it. 7 different world than we were last year when we were 8 discussing risk factors and what goes into a warning 9 label. 10 You're being very patient with me, We are really now in a We are now into the attributes of the drug 11 as it pertains to the risk factors. 12 things that, you know, if you look at any of the 13 objective contemporaneous evidence -- not in this case, 14 not for litigation -- if you look at what the AASLD was 15 struggling with, what the FDA is struggling with, what 16 hepatologists struggle with, they're trying to figure 17 out what is the risk utility of this drug as a whole as 18 it relates to acetaminophen's benefits on one hand and 19 acetaminophen's risks of liver disease on the other 20 hand. 21 And one of the And they -- some of them have suggested put 22 it behind the counter. 23 experts, we know that people take too much, and also we 24 know there's a low margin of safety. 25 3 grams and 2 grams. Golkow Technologies, Inc. Some of them, like defendants' Let's lower it to We also know doctors who actually Page 159 August 31, 2015 1 prescribe acetaminophen never go above 2 grams. 2 know a lot of things about this drug. 3 tethered to any particular plaintiff. 4 We And it's not A doctor doesn't say, "I have a patient 5 here who is malnourished. 6 2.5 grams; and I have somebody here who is not 7 malnourished, and I'm going to give them 3.5 grams." 8 That's not the kind of inquiry we make with risk 9 utility. 10 I'm going to give him We say, on the whole, do the risks outweigh 11 the benefits? 12 looking at it, that's where the cases get into trouble. 13 They are looking at these are all -- these are all 14 objective tests, and the Johansen case, to me, was the 15 most obvious one. 16 And that's honestly, at least as I'm The court said you have to go back, not at 17 the time the plaintiff is sitting there with her 18 acetaminophen bottle in her hand and has a drink or 19 two. 20 That's not the test for risk -- design defect. The question is, when she or anybody else 21 went to the Kmart to pick it off the shelf, when it was 22 marketed to her, what was the risk utility? 23 drinking when she put it off the shelf. 24 doing anything other than -- 25 THE COURT: Golkow Technologies, Inc. She wasn't She wasn't Where does her reading of the Page 160 August 31, 2015 1 label come in? 2 MR. TISI: It comes in as part of the -- as 3 the courts have said, contributory and comparative 4 negligence. 5 THE COURT: What is it that she read that 6 misled her to the extent that she did whatever she did 7 with the medication, which led to her injury? 8 really going to be that fact-specific for this jury. 9 MR. TISI: It might be when you get -- it's 10 not failure to warn. 11 road to some of the case-specific questions. 12 13 question about acetaminophen in the Jackson case. THE COURT: I'm concerned we're going to have a lot irrelevant testimony. 16 17 It might be as you get down the But remember, in this case there is no 14 15 It's MR. TISI: Let me address that question. I'm glad you raised that, Your Honor. 18 THE COURT: Thank you. Because when I read 19 these depositions, one word pops into my head on some 20 of these issues: 21 fuzzy, fuzzy, fuzzy, fuzzy. MR. TISI: Well, I mean, look, that's the 22 nature of a deposition. 23 opposing counsel of a witness, of an expert, the job is 24 to create fuzziness. 25 question -- Golkow Technologies, Inc. When you read a deposition by I mean, it's my job as to Page 161 August 31, 2015 1 THE COURT: 2 MR. TISI: 3 THE COURT: 4 MR. TISI: I mean, look, the point of the THE COURT: They don't hesitate to make 5 These are learned witnesses. Well, some of them are. They all are. matter -- 6 7 themselves heard. 8 good job of making sure they got the opportunity to be 9 heard. 10 11 12 And you and Mr. Jackson did a pretty MR. TISI: We kind of throw punches, pretty well, respectfully. THE COURT: When I sit back and look at all 13 of these, I said I don't know whether all of these 14 issues -- they're interesting. 15 may be interesting to the general public. 16 sure how relevant they are to the Jackson claim. 17 18 19 MR. TISI: They really are. They But I'm not If I was to say -- there's two questions there, and let me address them directly. If I was to put on evidence to gild the 20 lilly, and say to the witness, "And, by the way, isn't 21 it true that there are studies that this causes asthma 22 in children?" 23 24 25 I mean, I would agree with you. You probably -- you can't go there. But what they're trying to do, they're Golkow Technologies, Inc. Page 162 August 31, 2015 1 trying to say our evidence is so narrow that because 2 she had ALTs that resulted in a two-week 3 hospitalization, and that she didn't have -- that our 4 evidence is so narrow. 5 What I would propose is, and really what 6 the FDA and AASLD and everybody else did, they looked 7 at the liver risk versus the benefit. 8 9 And this issue of, well, now, Judge, we're going to be here for months and months and months. 10 Look, we put on Dr. -- 11 THE COURT: 12 MR. TISI: 13 16 We won't be. -- Plunkett. She sat in the chair for six hours. 14 15 Okay. THE COURT: She won't be on the stand for six hours. MR. TISI: She won't be either. I don't 17 put on witnesses that long. 18 Judge, if you would obey the law, we're going to be 19 here forever, that's kind of a red herring that I see 20 trotted out whenever we feel like we don't like where 21 the argument is going. 22 law says the risk, the benefit. 23 This idea that somehow, The truth of the matter is the I mean, if Mr. Kott is correct, if Mr. Kott 24 is correct in the statement of the law, are we not 25 going to hear anything about the osteoarthritis Golkow Technologies, Inc. Page 163 August 31, 2015 1 studies, the benefits studies? 2 Judge. 3 studies? Are we not going to hear about dental pain She wasn't having dental pain. 4 5 She doesn't have that, What's good for the goose is good for the gander. 6 THE COURT: I agree. Depending upon the 7 objection that you make and depending on what it's 8 offered in response to, I'll have to rule. 9 MR. TISI: Right. So, to me, the question 10 is, you can't go down the road -- I understand the 11 Court's desire to get to the issues. 12 salami-slice the evidence so tight that the jury 13 doesn't have an appreciation for the full benefit and 14 the full risk. 15 But we can't And so the focus in this case, as in any 16 case, the first question is on the design of the 17 product. 18 designed? 19 Ms. Jackson; it could be Mr. Kott sitting in that 20 chair. 21 the allegation is liver injury. 22 Is Extra Strength Tylenol defective as That's the question. It could be It doesn't matter, except to the extent that I would agree with you on that. We don't 23 want to get into extraneous issues involving the heart 24 or the brain or whatever the other issue is. 25 That's where the jury's first question is, Golkow Technologies, Inc. Page 164 August 31, 2015 1 before she even went to the shelf in Kmart to pick it 2 out, what are the attributes of that product with 3 relation to the benefit and liver risks. 4 And so the risk factors figure into that, 5 because I don't think a jury -- I don't think a jury is 6 really going to understand how dangerous this drug -- I 7 know we are talking about acetaminophen. 8 remind myself, everybody really takes this drug. 9 I have to They don't realize -- I know we have Wawa 10 down here and all that. 11 go in and they pick this up behind the Coke and the 12 potato chips, that depending upon factors that they 13 know about or not know about, they may be putting 14 themselves at risk. 15 pills. They don't realize when they They may take a couple extra They don't appreciate that. 16 And that's what this jury needs to 17 understand, or else, honestly, this case doesn't go 18 anywhere. 19 MR. KOTT: Very briefly. 20 MR. TISI: I'm done. 21 MR. KOTT: Mr. Tisi referred to the FDA, Thank you. 22 and the FDA looks at all the risks and all benefits, as 23 they should. 24 25 That's their statutory obligation. We're trying a case. don't want to pay it. Golkow Technologies, Inc. They want money. We We have jurors that are going to Page 165 August 31, 2015 1 decide under New Jersey law. 2 function. 3 That's a much different And let me get to the practical, because I 4 think that's going to drive the legal. 5 right, on some of these risk factors, as a matter of 6 law, they never could be the cause of her injury, 7 because either Taylor or Jackson, some of these risk 8 factors don't apply. 9 10 THE COURT: If Mr. Tisi is That's the problem. The risk factors have nothing to do with her injury. 11 MR. KOTT: And then we get to the 12 problem -- let me just finish, Your Honor. 13 to -- the problem is the jury just rendering an 14 advisory opinion, and we're having this whole long 15 opinion, whole long trial, an advisory opinion on 16 whether or not it's defective, when they might find 17 it's defective for some risk factor that not only is it 18 not the proximate cause, plaintiffs would concede, and 19 if they didn't concede, you take it out of the case as 20 a matter of law because it wasn't. 21 Then we get So why are we going to have all issues in 22 on defect, meaning every possible risk factor, when 23 90 percent of them -- and I don't know that I'm right 24 on 90. 25 a matter of law, can never sustain a verdict for the I might be wrong. Golkow Technologies, Inc. But a great many of them, as Page 166 August 31, 2015 1 2 plaintiff. MR. TISI: The defect -- we're changing 3 the -- it's like we're taking an hourglass and turning 4 it upside down. 5 the ability of this drug to cause acute liver injury. 6 That is the issue. 7 particular -- 8 9 The really proper inquiry, Judge, is Okay. THE COURT: No. And so the attributes of the The issue is whether or not this product was defective and as a result of that 10 your lady was harmed. 11 MR. TISI: That's a separate question. 12 That ends -- and whether she was harmed. 13 separate question. 14 THE COURT: 15 MR. TISI: Two parts. That's a Yeah. But the first question is 16 whether -- and it kind of goes to the question that we 17 were talking about before with the car. 18 If you have a -- a company is required, 19 when it designs a car, if it's designing a brake system 20 or an acceleration system, it has the duty to 21 anticipate all kinds of people who may use that car for 22 the purposes of stopping and starting that car. 23 24 25 Mr. Kott wants to focus on the particular risk factors. That's not the inquiry -- THE COURT: Golkow Technologies, Inc. No, you want to focus on the Page 167 August 31, 2015 1 risk factors. 2 MR. TISI: 3 THE COURT: 4 You -- because you are the one who is going to raise them in your case. 5 6 No, I want to focus on -- MR. TISI: I want to focus on the ability -- 7 THE COURT: And I don't know what relevance 8 is -- you're not saying she drank too much alcohol. 9 You're not saying that she was undernourished. 10 not saying that she was fasting. 11 testimony about those three things? 12 MR. TISI: You're Why are we hearing Because I'm saying this drug 13 caused acute liver injury and acute liver failure in 14 these patients. 15 saying, "Ladies and gentlemen of the jury, we have a 16 product that, when she picked it up, neither she nor 17 any other objective consumer who looks at this product 18 understood the low margin of safety of this product." 19 There are things about this product that are known, 20 alcohol, we believe fasting and malnutrition, they 21 don't. 22 things about this drug that you know and things about 23 the drug that you don't know that make it difficult to 24 accept the risks of this drug. 25 margin of safety is so small. And so I'm then going to the jury and That there are other risk factors and there are Golkow Technologies, Inc. And that's why the And that's why this is Page 168 August 31, 2015 1 an unacceptably dangerous product. 2 If the only people taking this drug were 3 healthy, 170-pound, well-nourished men, okay, we might 4 have a different issue. 5 is everybody. 6 room will go in and buy this drug. 7 But the market for this drug It's everybody. It's everybody in this So the question the jury will be asked is, 8 is the margin of safety appropriate for everybody? 9 With respect to liver disease -- again, I'm not talking 10 about brain injuries or heart disease or anything like 11 that. 12 what the jury is entitled to know, I believe under the 13 case law, before we get to Ms. Jackson or Ms. Taylor or 14 any other plaintiff in the case, is, is this drug from 15 an objective standard from the members of the jury, is 16 it -- is it defective, where the risks outweigh the 17 benefits. With respect to liver injury, is there -- and 18 19 The next question, then, is ultimately, you know, proximate questions and all those issues. 20 But the product -- the strict liability law 21 is really pretty untethered to that. 22 product. 23 MR. MILLING: It looks at the Your Honor, you asked a 24 specific question, why is it relevant to the Jackson 25 case. Golkow Technologies, Inc. Page 169 August 31, 2015 1 Because the issue that we are now trying is 2 not a warnings case. 3 it's taken me a while as well, having got a bunch of 4 stacks of things to read, to fully grasp my hands 5 around what we're now trying. It is a design defect case. And 6 We're trying the product. 7 all of the defects, are relevant to all objective 8 users, just like all of the benefits, dental pain, it 9 cures it. They are going to say episiotomy pain, it 10 cures it. It has nothing to do with Ms. Jackson, are 11 irrelevant. 12 And the product, And, Your Honor, I think as you were 13 reading the law, you even said defect predominates 14 proximate cause in a design defect case. 15 The first issue is, is the product 16 defective? 17 is, did the defect of the product cause the plaintiffs' 18 harm? 19 That's for the jury. Then the second issue In this case, both sides agree, 20 acetaminophen was the cause. So the case is going to 21 be driven on Issue Number 1. And Issue Number 1 under 22 New Jersey law and under Oklahoma law deals with 23 consumer expectation, deals with the five tests, deals 24 with risk utility. 25 plaintiffs. But it doesn't deal with the It just deals with the product. Golkow Technologies, Inc. And Page 170 August 31, 2015 1 that's why it's relevant to the Jackson case. 2 It's going to be a great trial. It's going 3 to be a very focused trial about Extra Strength 4 Tylenol, its risks and its benefits, and the jury is 5 going to decide, just like the advisory committee did. 6 They may agree with what the advisory committee did. 7 The advisory committee said these defects, in our 8 opinion, are so significant, even though you can take 9 it for a headache, that we think it should be only by 10 prescription. 11 They didn't look at Ms. Jackson or 12 Ms. Taylor. 13 essentially is what the advisory committee was doing, 14 what the jury is going to do. 15 risks, all the benefits, and make a decision. 16 what design defect cases are. They are looking at all comers. That They'll look at all the That's 17 I think it's difficult for -- maybe for all 18 of us to change our paradigm, because we're not talking 19 about a warnings case anymore. 20 MR. KOTT: 21 design defect cases all the time. 22 23 24 25 Not difficult for me. MR. MILLING: And as do I. I try But this is about the product. In pharmaceutical cases, we tie the motion to the warning. We don't have that anymore in the Golkow Technologies, Inc. Page 171 August 31, 2015 1 Jackson case. 2 experts that the cause of Ms. Jackson's injury and 3 nine-day hospitalization was acetaminophen. 4 And we have agreement amongst all the THE COURT: Okay. We have exhausted this 5 issue. 6 the plaintiffs' motions are denied without prejudice. 7 The defendants' motions are granted without prejudice. I think the approach I want to take to this is 8 9 I really do need to take more time myself looking at this. I'm not going to unnecessarily 10 hamstring the plaintiffs in making proofs that they 11 think they need to present, nor am I going to give them 12 free reign to simply have, you know, a loose discussion 13 about all the evils that are attributable to 14 acetaminophen and all the potential people -- again, I 15 look at some of these depositions, and I say to 16 myself -- and I look at some of the documents you've 17 given me, and, I mean, there was a study concerning 36, 18 38 people who consumed alcohol who had liver failure. 19 What about the fact that some of them may be alcoholics 20 and their liver has gone to hell without acetaminophen? 21 22 What do we do with that? Some of these proofs are murky. 23 MR. TISI: Well, I'll tell you why that's 24 important. 25 evidence, because in truth -- That's why I think you have to hear the Golkow Technologies, Inc. Page 172 August 31, 2015 1 THE COURT: I'm just remembering all the 2 things I've been reading over the weeks, and I say to 3 myself, "I don't know." 4 MR. TISI: I think intuitively you might -- 5 that might be an obvious to lawyers who sit here and 6 look at legal cases. 7 example, who knows that when you drink alcohol, you are 8 in effect causing a depletion of glutathione, okay, and 9 that is the mechanism by which we're talking about the 10 But to a toxicologist, for impetus for the -- 11 THE COURT: But that same person is going 12 to destroy their liver whether they ever took Tylenol 13 or not. 14 MR. TISI: Look, that's true. 15 when the damages come in. 16 understand at the end of the day -- 17 18 19 20 21 THE COURT: And that's Look, the jury is going to But we're not talking about alcohol with your lady. MR. TISI: But we are talking about -- the reason why those cases come in, those -THE COURT: You argued against the 22 discussion of alcohol, so we're not talking about 23 alcohol with her. 24 25 MR. TISI: But those studies are important not because they're alcohol patients, per se. Golkow Technologies, Inc. And Page 173 August 31, 2015 1 that's why you'll hear about this. 2 that is, when somebody is drinking their calories, as 3 opposed to -- they are developing a depletion of 4 glutathione. 5 yourself to an increased risk of liver injury. The importance of 6 When you deplete glutathione, you expose So there are multiple pathways in which you 7 can, known, unknown, that reduce glutathione in 8 patients. And that -- 9 10 THE COURT: Glutathione is in every cell, is it not? 11 MR. TISI: 12 THE COURT: 13 MR. TISI: It is. But -- Every cell of the body. But particularly it's in the 14 liver. 15 know and understand that glutathione depletion is 16 variable amongst people. 17 that increases -- that affects the margin of safety, 18 because this drug is not marketed -- I guess I can't 19 come at this enough to say, "Look, most drugs you go to 20 a doctor" -- 21 And the reason why that is important is, we now THE COURT: And because it's variable, I think the jury is going to 22 learn that the margin of safety for acetaminophen may 23 be more narrow than the public understands. 24 25 MR. TISI: That's right. And what's really different about this drug is, because it's not Golkow Technologies, Inc. Page 174 August 31, 2015 1 prescribed by a doctor and you can just go and buy it 2 at the Wawa, you know, there's this understanding and 3 perception that, you know, it's safe. 4 really -- 5 THE COURT: And so that's Well, we have that 6 understanding and perception about other 7 over-the-counter drugs too. 8 know, any medication, you take enough of it, it will do 9 you in. 10 MR. MILLING: And, you know, as we all I think what Your Honor just 11 said is exactly what we intend to prove in the case. 12 You said, I think the jury is going to come to the 13 understanding that the margin of safety is more narrow. 14 That's the design defect claim in its encapsulation. 15 THE COURT: 16 we do have to move on. 17 interesting. 18 forever. 19 I understand. For purposes -- This conversation's If I let it go, it will keep going on But, you know, the two motions of the 20 plaintiff are denied without prejudice. 21 motions of the plaintiff -- of the defendant on the 22 risk factors are granted without prejudice. 23 24 25 The two We're going to revisit this issue. I want to do some more reading on my own. MR. TISI: Golkow Technologies, Inc. Thank you, Judge. Page 175 August 31, 2015 1 MR. JACKSON: 2 THE COURT: 3 Thank you. I appreciate your arguments. think they are very enlightening. 4 Mr. Kott, you got that, two and two? 5 MR. KOTT: 6 THE COURT: 7 Okay. I got that one. I'm sure you do. Exclude evidence and argument of 8 defendants' draft company documents and intuitive 9 reports that were not decimated. 10 11 I Well, I guess the plaintiffs should tell me why I shouldn't grant that motion. 12 MR. HORN: Yes, Your Honor. Several 13 reasons. 14 I'll get to the next issue as well. 15 that if there are certain drafts that they are going to 16 claim are misleading, unfinished, prejudicial, 17 incomplete, we can deal with those one by one at the 18 appropriate time, whether it's in a sidebar or 19 whatever, and see if, in fact, they're too prejudicial. 20 To make an overbroad sweeping claim that -- 21 THE COURT: For starters, the motion is overbroad. this is the second time you said it. 23 not picking on you. 25 It's our position Just so you know, you said -- 22 24 And Believe me, I'm What I'd like to do at sidebar are things that pop up unanticipated and we all feel we can Golkow Technologies, Inc. Page 176 August 31, 2015 1 resolve very quickly. 2 be resolved quickly, it's going to get resolved early 3 in the morning before the jury gets in here, because I 4 don't like them sitting there while we're having an 5 extensive conversation off to one side. 6 that works well for any of us. 7 MR. HORN: If there's something that can't I don't think I agree, Your Honor. We can 8 just take out the word "sidebar" and put in "early 9 morning conference," whatever works for the Court. 10 That's something that we can deal with, and 11 that's the appropriate way to do it. 12 sweeping statement that no drafts come in completely 13 ignores the entire 403 process. It means that they 14 didn't establish the predicate. We don't even know why 15 these documents are prejudicial, number one. 16 of all, it's overbroad. 17 believes certain drafts shouldn't come in, let's take 18 them one by one, have them identify what they're 19 talking about, and we'll deal with it at an early 20 morning conference or at the appropriate time. 21 To make a So, first We would argue if Your Honor Secondly, Your Honor, it's our position 22 that these are admissible on a whole number of levels. 23 These drafts, especially in this case -- and I know 24 that Your Honor has read the facts. 25 revisit them all. Golkow Technologies, Inc. I don't want to Page 177 August 31, 2015 1 But these documents can go directly to 2 state of mind of the defendant, intent, marketing, 3 company motive, company conduct, regulatory strategy. 4 These drafts are actually woven into the entire Tylenol 5 decades-old and years-old saga. 6 with corporate witnesses. 7 experts. 8 9 They have been used They've been used with They are literally part of the case. If we were allowed to use them by Your Honor to address defense concern that these are 10 misleading, prejudicial, they will have every 11 opportunity to make us look bad and show the jury that, 12 by on direct asking whoever the witness is, "Isn't it 13 true, sir, that this was only a draft?" or whatever 14 they choose to deal with. 15 They can address this issue. But to argue that we fail under any kind of 16 403 analysis -- and as I read it, that's the heart of 17 their motion -- it doesn't make any sense, because 18 these go right to the probative heart of the matter. 19 If we're looking at the 403 seesaw, on a probative 20 side, it's down here at the floor, because we're right 21 at their marketing strategy, their state of mind, 22 notice to the defendant, why they chose to do certain 23 kinds of projects, certain kinds of experts, certain 24 kind of research. 25 The drafts are directly woven into that Golkow Technologies, Inc. Page 178 August 31, 2015 1 saga. 2 here, and this is where the prejudicial part is. 3 they want to make the argument that we're getting back 4 to this side, again, they can deal with it on cross, 5 they can deal with it on direct. 6 us look bad and show the jurors that we're pulling a 7 fast one by using an unfinished draft. 8 absolutely their remedy. So we are literally at -- the seesaw is right 9 If They can try to make But these are admissions. That's So, first of 10 all, they're definitely admissible. 11 saying is just, they're admissible but they're too 12 prejudicial. 13 Our argument is, absolutely not. 14 100 percent probative. 15 They're involved in every saga. 16 depositions. 17 18 So all they're 19 They're directly on point. They've been used in And if there happens to be one draft -THE COURT: discovery. They are Lots of things get used in They don't turn out to be evidence. MR. HORN: And you know what, Your Honor, 20 100 percent true. 21 that we used completely wrong, we'll pull it out one by 22 one. 23 And if there happens to be a draft THE COURT: I'm going to grant this motion 24 without prejudice, and we'll renew this document by 25 document if we need to, or types of documents by types Golkow Technologies, Inc. Page 179 August 31, 2015 1 of document. 2 will revisit it depending upon what documents you want 3 to show me are really important to your case. 4 I'm going to grant the motion, and we MR. HORN: As I said, Your Honor, prior to 5 opening statement, prior to any witness, we'll just 6 approach Your Honor and say we'd like to use these 7 documents, and we can just litigate it at that point. 8 9 THE COURT: That may be the way we do it. If you think you're going to be using some of these in 10 your opening statement, we're certainly going to have 11 to talk about it before then. 12 MR. HORN: 13 MR. MILLING: That's fine. I want to make sure I address 14 one thing. 15 to not only draft documents, but to internal company 16 documents. I believe the motion also somehow expanded 17 THE COURT: 18 MR. MILLING: 19 argued. I believe so too. And I presume that had been The focus has been on drafts. 20 THE COURT: 21 difficult than internal documents. 22 use was made of the internal documents. 23 the context of them. 24 is sending it? 25 all of that to know. The argument on draft is more I don't know what How important is the person who Who is the audience? Golkow Technologies, Inc. I don't know I would -- I need Page 180 August 31, 2015 1 MR. MILLING: So, you know, examples of 2 internal documents, e-mails between corporate witnesses 3 that are discussed with them. 4 to make sure that your granting of this motion is not 5 saying that all internal documents of McNeil are not 6 going to be -- 7 THE COURT: 8 revisit this, we will. 9 example. And I guess I just want It's not. If we need to Mr. Horn just gave a very good If there is a document that he thinks is so 10 important that he wants to discuss it with the jury in 11 the opening, we're going to have to look at that 12 particular document and talk about it before the 13 opening comes. 14 And we will. MR. MILLING: I think I also speak, lastly, 15 for Mr. Tisi as well. 16 I don't know, as I stand here today, what documents the 17 defense claims that I used throughout this case that 18 are drafts, whether -- I don't know if they are 19 claiming documents that were not marked drafts are 20 drafts. 21 are drafts. We took most of the depositions. I don't know what documents they're claiming 22 Some documents may say, you know -THE COURT: They're not saying anything, 23 because I granted their motion. 24 without prejudice to the right to revisit it document 25 by document. And I granted it We're on to the next one. Golkow Technologies, Inc. Page 181 August 31, 2015 1 Exclude evidence or argument related to 2 defendants' profit margins, net worth, or other 3 financial information. 4 There's no reason not to. 5 I'm going to grant that. MR. HEWES: Judge, did we skip defendants' 6 motion in limine Number 1? 7 brief minute. 8 MR. TISI: 9 THE COURT: 10 I know I stepped out for a We did not do it. We skipped it. Let's deal with my third one first. 11 Evidence concerning profit margins, net 12 worth, other financial information. 13 grant that? 14 MR. MILLING: Why shouldn't I First of all, we absolutely 15 agree that as to the wealth of the company, that that 16 does not come in. 17 Extra Strength Tylenol versus regular strength Tylenol, 18 one product being $440 million and one being a 19 $14 million product, that goes right into the heart of 20 the case. 21 mind. 22 want to warn, want to redesign, not want to redesign. 23 As to profits, as it relates to That goes to motive. It goes to state of It goes to whether defendants want to warn, not In fact, as the Court knows, right after 24 the advisors in 2009, the best example said, we would 25 like -- we believe as scientists that this drug should Golkow Technologies, Inc. Page 182 August 31, 2015 1 be put behind the market. 2 to save Extra Strength Tylenol. 3 is right in the wheelhouse. 4 There was an entire effort They have done -- this We've got financial analysis of what 5 happened to Extra Strength Tylenol versus regular 6 strength Tylenol if the advisors -- if their 7 recommendation comes true. 8 9 We cited a case, just to back up. We cited, Your Honor, to the case of the asthma MDL case, 10 which I think really highlights the tension that goes 11 on in a company between profits and the desire to warn 12 or redesign the product. 13 said, evidence about sales goals, which is profit, is 14 certainly relevant when it may impact the 15 decisionmaking regarding labeling of the product or 16 design, whatever the case is. 17 And the court in In Re Yasmin There is an inherent tension between the 18 desire for profit and scientific decisions to suggest 19 warnings may well shrink the consumer base. 20 tension was echoed and agreed to by the president of 21 the company, Ashley McEvoy. 22 the side effects, when we warn about more side effects, 23 can affect the brand's public perception and the 24 reputation and lead to a decrease in sales. 25 This She said in her deposition Where are we? Golkow Technologies, Inc. Page 183 August 31, 2015 1 THE COURT: I'll tell you where you are. 2 We're probably going to have that discussion when one 3 of you is cross-examining one of their witnesses. 4 MR. MILLING: 5 THE COURT: Okay. As a general proposition, I'm 6 granting it. 7 that you are trying to make when we have a witness on 8 the stand, we're going to revisit it. 9 do right now. 10 But if you can convince me of the point That's all I can I need to see it framed better. And I 11 don't think we're going to be able to do that today in 12 terms of the tension that you're talking about. 13 MR. MILLING: Or the motive to do something 14 or not to do something, or what the e-mails say about 15 we really need to really beef up our marketing of Extra 16 Strength Tylenol because it's dropping, or the 17 desire -- 18 THE COURT: 19 everybody wants extra. 20 Everybody wants the Big Gulp. 21 22 It's funny. In America, MR. MILLING: Everybody wants bigger. That's the -- there are documents that -- 23 THE COURT: That's America. 24 MR. MAYES: Your Honor, this stuff about 25 motive and corporate state of mind, I don't believe Golkow Technologies, Inc. Page 184 August 31, 2015 1 either one of those are applicable in a strict 2 liability case. 3 inject a bunch of big dollar figures. 4 5 6 This is nothing but an attempt to THE COURT: distracted me. You make a good point. We'll deal with that in context. Let's go back to Number 1. Exclude 7 evidence or argument of adverse event reports. 8 last time we discussed this. 9 But I denied it with such a qualifier that the 10 11 You Now, Last year I denied it. plaintiffs know they have a very heavy burden of proof. And why don't we say that my ruling last 12 year is incorporated by reference. 13 2014 -- and if you look at the answer to that or the 14 ruling, notwithstanding this ruling, plaintiff must 15 proffer with specificity the nature, quality, and 16 number of adverse event reports, more directly the 17 precise AERs sought to be referenced. 18 My August 21, Such report must be relevant to the time 19 and facts of plaintiffs' claims. 20 generally predisposed to preventing an expert witness 21 to reference AERs during their testimony -- the court 22 confirmed with counsel on the wording of the limine 23 charge to be given by the jury by the court in advance 24 of any testimony regarding AERs. 25 While the court is Finally, it is very unlikely that any AERs Golkow Technologies, Inc. Page 185 August 31, 2015 1 will be considered on the issue of causation. 2 think we're going to have anything like it. 3 I don't So, again, their motion is denied. So I'm 4 ruling in your favor. 5 have to convince me that AERs of any nature are going 6 to be coming in. 7 MR. TISI: You know that you are going to And I'm happy to do that. 8 me address that question. 9 ruling. 10 Let I understand the Court's AER evidence, as the Court knows, in 11 pharmaceutical cases falls into two buckets. 12 the pharmacovigilance bucket, which is basically what 13 the defendant knew and did not know about and 14 understood about the risk profile of its drug. 15 given our discussion before about design defect, it's 16 particularly important because that's how companies 17 understand the risk profile of the drug. 18 One is in And When a drug is marketed, it only has a 19 certain clinical trial base. 20 is marketed to millions of people, then they get to 21 gain experience with the drug, both through informal 22 and in published case reports. And when it goes out and 23 And through that process of 24 pharmacovigilance, they get a better handle on what 25 does the risk and benefit profile of the drug look Golkow Technologies, Inc. Page 186 August 31, 2015 1 like. That's one area. 2 And the courts are really clear that 3 adverse events -- and they don't even have to be that 4 similar -- come in. 5 Decker versus GE Healthcare, 770 F. 3d 378, 2014, from 6 the Sixth Circuit. 7 And I will again cite the Court to THE COURT: I've read those cases. I've 8 also read the federal manual on medical evidence. 9 we all know we're talking about hearsay evidence. 10 So -- and I'm not telling you that I won't 11 let you refer to them. 12 you are going to have to re-make later. MR. TISI: 14 THE COURT: You are making an argument that 13 15 And And just for the record -We're going to move on to the next. 16 MR. TISI: 17 THE COURT: That's fine. You are going to get a chance 18 to make your record. 19 I'm putting you on notice that you've got some heavy 20 lifting to do. 21 MR. TISI: 22 THE COURT: I've denied their motion. 23 I'm happy to lift heavy. Save your energy for the lifting later. 24 25 But MR. HEWES: Can I briefly address this, Your Honor? Golkow Technologies, Inc. Page 187 August 31, 2015 1 THE COURT: 2 employee compensation? 3 MR. HEWES: Exclude evidence regarding No, Your Honor. You said it's 4 probably not likely an issue of causation, possibly for 5 the adverse event reports. 6 7 THE COURT: event reports? You want to be heard on adverse Go right ahead. 8 MR. HEWES: Just on the notice issue. 9 THE COURT: Go right ahead. 10 MR. HEWES: And I don't plan to be very 11 long. 12 defect case only, and we've been discussing the various 13 jury instructions related to that. 14 THE COURT: 15 We talked about the fact that this is a design And 5.40 D-3 -- It's something I can assure you I'll be re-reading tonight. 16 MR. HEWES: Yes, Your Honor. It says, "In 17 proving a defect in the design of a product, plaintiff 18 need not prove that the manufacturer knew that the 19 accident in the case could happen as it did. 20 is imputed." 21 Knowledge This is a design defect case only, now, 22 Your Honor. 23 in a design defect case. 24 since day one, but in this case, in the Jackson case, 25 the element of notice is removed because notice is Notice is not an issue to the manufacturer Golkow Technologies, Inc. We've heard notice all along Page 188 August 31, 2015 1 imputed to the manufacturer, number one. 2 Number two, Your Honor said when discussing 3 ones that may come in, documents that may come in, that 4 they -- per your Court's order that you just read, the 5 adverse events report must be relevant to the time and 6 facts of plaintiffs' claims. 7 argument. 8 Honor has seen the expert discovery. 9 seen the plaintiffs' testimony. You heard last week the Your Honor has read the complaint. Your Your Honor has And I've got all the 10 documents here if you want to look at them, Your Honor. 11 But this is a case where, from the very beginning, from 12 the complaint, they allege that the plaintiff suffered 13 the following liver injury. 14 in her complaint, that she had elevated liver enzymes. 15 Nowhere in the complaint does the plaintiff allege that 16 she suffered acute liver failure. 17 no doctor ever -- 18 And this is Paragraph 20 The plaintiff said THE COURT: They call it acute liver 20 MR. HEWES: Liver injury. 21 THE COURT: That's a claim. 22 MR. HEWES: It is a claim. 23 THE COURT: She was hospitalized for quite MR. HEWES: Absolutely, Your Honor. 19 24 25 injury. a while. Golkow Technologies, Inc. But my Page 189 August 31, 2015 1 point is, she never suffered acute liver failure. 2 so the plaintiffs, if they were truly going to put in 3 her notice documents relevant to the times and facts of 4 plaintiffs' case, there should be no adverse event 5 reports or notice where somebody suffered acute liver 6 failure. 7 limited to someone who, just as they plea, took an 8 overdose of acetaminophen, by their own admission, and 9 developed elevated liver enzymes. And The adverse events that they put in should be And if you're going 10 to keep it boxed in to the facts and time relevant to 11 plaintiffs' claims, that's it. 12 MR. KOTT: And I just want to supplement on 13 Mr. Hewes' first point. 14 Jackson by virtue of the Court's orders. 15 out. Here is the lay of the land in Negligence is So the only issue we're trying is design defect. 16 When you look at Section 4 of the Product 17 Liability Act, that's the design defect, and it talks 18 in terms of a safer, feasible, alternative design. 19 That's carried through to the model jury charge. 20 And the model jury charge, as Mr. Hewes 21 said, not only does not require notice to be an element 22 of the plaintiffs' case, just the opposite. 23 presumed. 24 Court. 25 Notice is presumed. It says it twice. Notice is I can read it to the When you read it tonight, you'll see it. Golkow Technologies, Inc. Page 190 August 31, 2015 1 2 So they're -- in Jackson, arguing that it's for notice, that's inadmissible. 3 As soon as Mr. Tisi changes -- and if we 4 had a game show, I'd ring the bell loudly, because he 5 changed. 6 of a sudden it was pharmacovigilance, not notice. 7 Meaning he wants to offer it for substantive evidence. I don't know whether you saw it -- then all 8 MR. TISI: No. 9 MR. KOTT: Let me finish. 10 MR. TISI: I'm sorry. 11 MR. KOTT: And there are two points to 12 that. 13 substantive evidence, we have like three or four levels 14 of hearsay, some of which they can come in with 15 exception, one of which they'll never be able to 16 satisfy an exception. 17 evidence -- and this is where it gets a little 18 complicated. 19 about it -- it's not a negligence case. 20 liability case, reasonable alternative design. 21 Therefore, if we never had any notice, none at all, we 22 still could be found liable by the jury because there 23 was a feasible alternative design. 24 25 Number one, as soon as he offers it for And if he's offering substantive And I'll do it and let the Court think It's a strict If we had tons of notices, 20 million notices, and the jury found that the product was safe Golkow Technologies, Inc. Page 191 August 31, 2015 1 as designed, we would win. 2 it is a strict liability design defect case. 3 a negligence case. 4 element and our conduct does not come in. 5 as soon as Mr. Tisi -- and I'm going to yield to him in 6 a minute if the Court will allow me to. 7 And the reason for that is It's not And, therefore, notice is not an But, again, As soon as Mr. Tisi says, "Well, it's not 8 just notice. 9 A, that's hearsay. We want to do it on pharmacovigilance," And, B, that's not relevant, given 10 the Court's earlier orders striking negligence and 11 saying only design defects when we look at statute and 12 when we look at the model jury charge. 13 MR. TISI: Judge, pharmacovigilance is -- 14 is a lot more than simply notice issues. 15 before me -- and I thought this would be a longer 16 argument than it is -- but I have the testimony from 17 the director of pharmacovigilance for McNeil. 18 And I have I asked him the question that the jury will 19 be asked, which is, "How do we decide what the risk 20 profile of the drug is?" 21 question. 22 Okay. I asked him that This isn't just a notice issue. I asked him -- and this is page 78 of 23 Dr. Kwong. 24 say risk profile, what doctors and patients want to 25 know primarily when they are taking a drug is they want I ask him, "So when doctors -- and when I Golkow Technologies, Inc. Page 192 August 31, 2015 1 to know the risk. 2 were to happen, how often does it happen? 3 Is there a risk and if something "Okay. The frequency, character, and 4 severity are important concepts in developing the risk 5 profile of a drug. 6 on the risk side, frequency, character, and severity." Right? So, again, that's the issue 7 The answer was, "Yes." 8 "So one of the things that was being 9 discussed in the early 2000s in the medical and 10 scientific community were the use of different lines of 11 evidence. 12 event reporting and if you have epidemiology, all of 13 that, how to pull it together and figure out what, in 14 fact, is the frequency, character, and severity of a 15 liver risk associated with a drug. Clinical trials, toxicology, and adverse 16 "Answer: 17 Okay. Yes." So despite what Mr. Kott is saying, 18 the way in which the medical community -- in fact, the 19 way in which McNeil figures out the risk profile of the 20 drug is to look at all of the lines of evidence. 21 You know, I've heard over and over again 22 about the fact that case reports cannot inform you as 23 to the rate of -- because there's no control. 24 true. 25 asked to me; it doesn't define the rate. That's I would say that, too, if that question were Golkow Technologies, Inc. But it does Page 193 August 31, 2015 1 define the character and severity of the risk that a 2 patient can have when they take a drug. 3 So case reports are very important and very 4 informative in the pharmacovigilance perspective. 5 are also important -- and you refer to the manual -- 6 they are also important, we heard from the various 7 drug-induced liver disease experts, I brought books, 8 about how they define causation. 9 that they look at is case reports. 10 They And one of the things But I will refer you to the Manual of Scientific Evidence. 11 This is from the -- this is from the second 12 edition of it. 13 and do not provide as much information as controlled 14 epidemiological studies do." It says, "Case reports lack controls 15 Of course they don't. 16 "However, case reports are often all that I agree with that. 17 is available on a particular subject because they 18 usually do not require substantial, if any, funding to 19 accomplish and human exposure may be rare and difficult 20 to study." 21 That's true with acute liver failure. 22 "Causal attribution based upon case studies 23 24 25 must be regarded with caution." True. "However, such studies may be carefully considered in light of all the other information, Golkow Technologies, Inc. Page 194 August 31, 2015 1 including toxicologic data." 2 Judge, I've heard over and over about the 3 Manual for Scientific Evidence. 4 I've heard over and over again how case reports are not 5 used. 6 that generally. 7 I have it right here. They are used in causation algorithm. We know We know that in drug-induced liver disease, 8 we heard it from Dr. Kaplowicz and from Dr. Flann, and 9 we know that the courts in this jurisdiction have 10 11 always permitted it. The McCarrell case? They go on for three 12 pages about how case reports, if used in connection 13 with other evidence, it can be pulled together to 14 decide what the risk profile is. 15 and, in fact -- 16 17 18 THE COURT: And so -- you know, I've ruled in your favor. We're still having this conversation. MR. TISI: Okay. Well, I'm responding to 19 counsels suggestion that somehow pharmacovigilance is 20 not relevant to this case. 21 THE COURT: Of course it is. Number 4, exclude evidence and 22 argument relating to employee compensation. 23 shouldn't I grant that? Why 24 MR. MILLING: 25 Last year you said that we can mention that Golkow Technologies, Inc. Thank you, Your Honor. Page 195 August 31, 2015 1 they were employed and they were compensated. 2 could not -- 3 4 THE COURT: But we Isn't it true you are an employee of so-and-so and you are paid by them? 5 MR. MILLING: But we can't talk about the 6 amount, but you excluded Dr. Temple from that because 7 he has a specific contract where now he's paid -- 8 9 10 THE COURT: changes. Nothing changes. Nothing Generally, we're not going to get there. 11 12 You are correct. MR. MAYES: Yeah, we do get to take that up about Dr. Temple before they start asking -- 13 THE COURT: 14 Exclude opinion testimony regarding 15 defendants' state of mind. 16 17 We will. Talk to me about that, defense counsel. What is it that you're concerned about? 18 MR. KOTT: We don't allow a witness to get 19 on the stand and say, "Here is the intent of someone 20 else." 21 But what's going on, they are looking at some 22 documents, presumably the documents in evidence, and 23 then they give an opinion as to -- 24 THE COURT: 25 This is basic. It's -- experts are doing it. What? You are talking about Plunkett? Golkow Technologies, Inc. Page 196 August 31, 2015 1 MR. KOTT: 2 THE COURT: 3 Yeah. She won't be talking about anybody's state of mind. 4 MR. KOTT: Okay. 5 MR. HORN: Your Honor, just very briefly to 6 respond. 7 conduct the same strategy we did with the documents. 8 Just looking at the motions, there are -- 9 This may be an issue which we ask you to THE COURT: 10 MR. HORN: It's a broad motion. It's a broad motion. They cite 11 an example where one expert said this company cares 12 more about publicity than profits. 13 example. It's been struck down, I get it. 14 15 THE COURT: prejudice. 16 Pretty extreme I'm going to grant it without If we need to revisit it, we will. MR. HORN: For example, Your Honor, if we 17 believe there is an area of a witness's testimony that 18 may bleed into that, we'll raise it before testimony 19 and ask that it be -- to be heard. 20 THE COURT: 21 Exclude evidence or argument relating to 22 25 Thank you. fraud on the FDA. 23 24 That's good. MR. KOTT: Buckman. I have a one-word argument: I'll sit down. THE COURT: Golkow Technologies, Inc. Mr. Mulling. Page 197 August 31, 2015 1 MR. MILLING: First of all, Your Honor, we 2 have no claim for fraud on the FDA. 3 case distinguishes between the cause of action and 4 evidence. 5 And the Buckman In this case, we have causative action, 6 not -- evidence, not cause of action. 7 decision that they cited, I believe it said regardless 8 of how the plaintiffs style the claims, if it is a 9 claim that could not be articulated but for the In the Cornett 10 existence of a federal requirement allegedly violated, 11 it is a functionally equivalent -- it is functionally 12 equivalent to a claim that is grounded solely on the 13 federal violation. 14 They are not grounded but solely on any sort of fraud 15 on the FDA or but for fraud on the FDA. 16 Our claims do not meet that test. But what the defendants fail to cite is in 17 the Cornett decision. 18 plaintiffs' failure-to-warn claim, based on other 19 allegations of wrongdoing, apart from defendants' 20 failure to file an FDA disclosure, it's not preempted. 21 It says to the extent Buckman is a very narrow holding. And in 22 our claims in this case, certainly the interaction 23 between McNeil and the FDA is relevant. 24 as to warnings and design. 25 It's relevant First, as to warnings and design, in your Golkow Technologies, Inc. Page 198 August 31, 2015 1 recent order, you even mention that there's 2 black-and-white evidence that the instructions on the 3 product at the time of the ingestion, the plaintiff was 4 not in conformance with the TFM. 5 between McNeil and FDA that may be discussed in these 6 cases. 7 That's an interaction As it relates to the safety of 8 acetaminophen at 4 grams per day, McNeil says, you 9 know, the -- they submit certain documents to the FDA 10 with their arguments that are public documents. 11 certainly should be able to go into those and explain 12 why those representations and the company's state of 13 knowledge regarding the 4 grams is inaccurate. 14 We Bottom line, Buckman is very, very narrow, 15 and we're not claiming fraud on the FDA in this case. 16 It is a design defect case and one case. 17 18 THE COURT: You're not claiming fraud. That's why I will grant the motion. 19 MR. MILLING: 20 THE COURT: 21 Thank you. Exclude evidence of unrelated manufacturing and regulatory matters. 22 MR. MILLING: I presume you meant to say 23 we're not claiming fraud on the FDA, so you'll deny the 24 motion. 25 THE COURT: Golkow Technologies, Inc. The motion is to exclude Page 199 August 31, 2015 1 evidence relating to fraud on the FDA. 2 MR. MILLING: But it goes on to talk about 3 interaction with the FDA. 4 just fraud on the FDA, we are not claiming fraud on the 5 FDA. 6 THE COURT: And to the extent that it's Okay. Of necessity, because of 7 all the communication there's been, the exchanges 8 between McNeil and FDA are certainly relevant. 9 10 MR. MILLING: That's right. evidence -- 11 THE COURT: 12 because you're not claiming fraud. But the context is not fraud, 13 MR. MILLING: 14 THE COURT: 15 Thank you, Your Honor. Okay. Exclude evidence of unrelated manufacturing and regulatory matters. 16 MR. MILLING: 17 THE COURT: 18 MR. MILLING: 19 That response to that. Is that Number 7, Your Honor? Yes. I believe we did not file a That has to do with other issues. 20 THE COURT: 21 Exclude evidence of other lawsuits or 22 25 That's granted. settlements. 23 24 Okay. MR. KOTT: Does the court need to hear from me? THE COURT: Golkow Technologies, Inc. Is there any reason that I'm Page 200 August 31, 2015 1 not going to grant that? 2 MR. MILLING: Your Honor, we have cited a 3 number of cases. 4 specifically the case both parties cite, the Wimms 5 versus Toombs (ph) case. 6 we're not trying to show that other lawsuits are being 7 offered for the truth of the matter, but defendants, 8 when they receive a lawsuit or a claim, they are 9 required to assess that with their pharmacovigilance, And we refer you to the case, And the issue is whether 10 required to report it to the FDA, fill out a 3500. 11 They are trying to investigate it. 12 And it does not need to be substantially 13 similar. 14 it said that the standard for similarity of other 15 incidents sought to be introduced is relaxed when 16 evidence is offered to show notice. 17 In fact, it's the Wimms versus Toombs where Other lawsuits and other claims can be -- 18 other lawsuits can be introduced, not to show there was 19 a verdict, not to show there was a settlement, but to 20 show there was notice of a claim if the lawsuit 21 involved acetaminophen and a liver injury. 22 I'd also cite the Court, there have been 23 cases involving Johnson & Johnson where this came in. 24 That's the first Persuad versus Johnson & Johnson case. 25 We cited the In Re Gadolinium case, where the knowledge Golkow Technologies, Inc. Page 201 August 31, 2015 1 of other claims in lawsuits was admitted. 2 Arnold versus Riddell, the case involving helmets, said 3 it was error to not allow other accidents or lawsuits 4 with the same type of football helmet because the 5 evidence went to notice of a potential design defect 6 and the adequacy of the warnings. 7 We cited So the real -- the real -- what the 8 defendants are really saying is it's hearsay. 9 not offering it for the truth. We're We're offering it for 10 notice. 11 probative. 12 think we ought to be able to talk about it. Under the 403 analysis, it's certainly And it's not unduly prejudicial. 13 THE COURT: 14 MR. KOTT: And we Mr. Kott. Your Honor, you were a 15 practicing lawyer. 16 junk. 17 writes up a complaint. 18 it in as good a light as he can or she can for his 19 claim. You're a judge now. And I don't use that pejoratively. Complaints are But a lawyer And of course he's going to put It would be negligent not to. 20 We come back to notice. It's everything I 21 said before. 22 important, because I want to fast-forward the court to 23 the trial, because -- and I'm going to hope that 24 notice -- ultimately the court says notice doesn't come 25 in. But I just want to -- this is so Golkow Technologies, Inc. Page 202 August 31, 2015 1 2 But let's assume it does, or it comes in the back door through the experts, 703. 3 What we're going to have, Your Honor, is 4 we're going to have experts talking to the jury about 5 this much inadmissible stuff, when on the stuff that 6 would be admissible substantively, there's this much. 7 And even if the Court is inclined to give a 8 modified Agfa jury instruction -- I'm mispronouncing, 9 but I think the jury knows what I'm referring to -- 10 there's no way we get a fair trial. 11 Six weeks, for the first three or 12 four weeks, the plaintiffs are putting in things on 13 notice, not admissible substantively, putting in things 14 through 703. 15 things that are not admissible. 16 And we're overwhelmed with non-evidence, There's nothing Your Honor can do about it 17 now. 18 think about it. I raise it because I'm hoping to get the Court to 19 THE COURT: 20 MR. KOTT: I am. We're not going to get a fair 21 trial if that happens. 22 says jurors follow instructions of judges, but our 23 jurisprudence also recognizes that sometimes things can 24 happen in trials where, no matter what the instruction 25 of the judge was, the jurors can't really follow it. Golkow Technologies, Inc. And I realize our jurisprudence Page 203 August 31, 2015 1 And that's my concern here. 2 It doesn't have to be addressed. Notice is 3 not relevant. 4 element of the case. 5 table, because I'm very worried about us not getting a 6 fair trial. 7 Notice doesn't come in. It's not an MR. HORN: But I did want to get it on the Just to address that, Your 8 Honor, I can assure counsel and the court nobody wants 9 a six-week trial where most of the evidence is not 10 admissible. 11 an angry jury, exhausted lawyers, and you just got like 12 a nuclear scenario, which I have never seen happen in 13 any of my products trials, and I don't think my counsel 14 have either, and we've both been through a lot of them. 15 My suggestion is if Your Honor is okay with 16 it, is you seem to have set a trend, which I think will 17 work very well, where if we have an issue that we think 18 is relevant and passes all judicial muster, we'll raise 19 it with Your Honor and say we want to use this and can 20 we use it at the appropriate time as part of the case. 21 And so I ask Your Honor, if it's okay with That's not good for anyone. That leads to 22 the Court, a notice issue, let's follow the same 23 pattern. 24 25 THE COURT: inclination. Well, that remains my I'm going to grant the defendants' motion Golkow Technologies, Inc. Page 204 August 31, 2015 1 to exclude evidence of other lawsuits. 2 I just think that the potential for 3 prejudice outweighs the value of them. 4 know how far we're going to go in terms of notice, but 5 the jury has to assess this case based upon the 6 testimony of the plaintiff and the experts regarding 7 whether or not the defect which is contained in the 8 label affected her in such a way that she took Tylenol 9 and it caused her harm. 10 And I don't At the end of the case, that's what's happening here. 11 So we're not going to get into other 12 lawsuits that were filed. 13 exclusion of evidence regarding other lawsuits or 14 settlements is granted. 15 Defendants' motion on Number 9, exclude evidence or argument 16 regarding unrelated products or any documents, events, 17 or labeling changes that postdate December 2009. 18 this is -- yeah, this is on Taylor, this one. 19 Tell me why I shouldn't grant that. 20 MR. MILLING: Your Honor, this has to do 21 with subsequent remedial measures. 22 THE COURT: 23 MR. MILLING: 24 25 So Yes, this is on Taylor. I think it's in Jackson as well. THE COURT: Golkow Technologies, Inc. Yeah, it would be Jackson as Page 205 August 31, 2015 1 well. 2 MR. MILLING: 3 First, as to Rule 407, deals with Jackson as well. 4 subsequent remedial measures, and the Court, in your 5 order on design defect, actually cited McNeil's 6 voluntary reduction from 4 grams to 3 grams as evidence 7 of feasibility. 8 want to keep out, 4 grams to 3 grams, Your Honor has 9 said that is the evidence of feasibility. 10 11 12 And so as to one of the issues they So that evidence should stay in for certain evidence to come out. It says that "Although subsequent remedial 13 measures cannot be used to prove negligence, they can 14 be used to prove other issues." That's what 407 says. 15 And feasibility is certainly one of those. 16 is one of those. 17 Knowledge Changes to the prescription label as 18 occurred in 2011. 19 case, but I have a big feeling that the door is going 20 to be open as soon as the defendants make any sort of 21 suggestion about limitations on what they can do and 22 have the relationship with the FDA. 23 able to show to the jury -- they are going to imply, 24 for example, that at all times Extra Strength was 25 approved by the FDA, something of that nature. We don't intend to put that in our Golkow Technologies, Inc. We're going to be At that Page 206 August 31, 2015 1 point, we're going to assert actions were not taken by 2 the FDA. 3 explain, wait, the jury has to understand the full 4 regulatory system. 5 FDA has the authority to decrease acetaminophen. 6 in fact, it has done so. 7 prescriptions in this country with Extra Strength 8 Tylenol in them like they used to be. 9 strength Tylenol. 10 monograph system. 11 That's going to open the door to us to Under the prescription area, the And, There are no more Only regular But they couldn't do it in the So the 2011 reduction in prescription 12 acetaminophen will come in if the door is opened by any 13 suggestion of the defendants. 14 to doctors which is a public document, "Please do not 15 prescribe any more prescription medication containing 16 Extra Strength Tylenol, 500 milligrams," will come in 17 if the defendants open the door. 18 The FDA's pronouncement And the last -- right, and also, again, 19 they also come in as affirmative evidence on the case 20 on causation, on design -- especially on the design 21 defect aspect of this case. 22 The last issue they've asked to keep out is 23 the notice of proposed rulemaking. 24 looked it up. 25 a decision on acetaminophen in December of 2015. It's very vague. I Apparently the FDA may be posed to make Golkow Technologies, Inc. Page 207 August 31, 2015 1 Nobody knows what that is. 2 defense on that, that we should not discuss the fact 3 that the FDA may make some decision that is not 4 articulated in the Federal Register. 5 And I concur with the But as to the 403, which postdates the 6 injury, Your Honor, that's feasibility and it's been 7 cited to Your Honor. 8 9 As to the prescription, that's feasibility; that goes to notice; that goes to design. 10 11 And certainly, if the door is opened, and the same with pronouncements by the FDA. 12 THE COURT: Mr. Hewes. 13 MR. HEWES: Yes, sir. Let's not forget 14 that lost in a discussion of design defect and 15 feasibility is that it has to be feasible at the time 16 of the manufacture of the product that the patient 17 ingested. 18 It's not feasibility open-ended. The assessment as to whether a safer, 19 practical, feasible alternative design existed stops 20 the date her product was manufactured. 21 that you can look forward to see if something in the 22 future is feasible is not one of the elements to design 23 defect. 24 out completely in Regina Jackson and the design defect 25 element for feasibility for Taylor is also out as well, So to suggest So that that keeps post-ingestion activities Golkow Technologies, Inc. Page 208 August 31, 2015 1 which leaves us with essentially the subsequent 2 remedial measure issue and a failure to warn, as they 3 would be putting out or suggesting things that happened 4 post-injury for negligence purposes or to prove 5 negligence. 6 remedial measure. That's not allowable under subsequent 7 I think Your Honor got it right when you 8 were assessing the Lyles case, which is more akin to 9 the Taylor case than it is the Jackson case, when Your 10 Honor said, quote, "I don't see the relevance of it. 11 I'm granting it in accordance with 403 and common law." 12 And we don't think, for those two reasons, 13 even if it postdates the injuries, either of these 14 claimants, for design defect purposes at the time the 15 product was manufactured that they ingested, and in 16 Taylor, should be out. 17 MR. MILLING: Your Honor, in your order, 18 you said, "The actual change in the recommended dose in 19 the summer of 2011 arguably demonstrates the 20 feasibility and practicability of this alternative 21 design. 22 that, as you know. 23 way the tentative final monograph was done in 2006, in 24 2007, in 2008, in 2002, and any time before. 25 chose not to do it. You cited that. Golkow Technologies, Inc. The defendant was free to do And you've also cited based on the But they And it was recommended by numerous Page 209 August 31, 2015 1 scientific bodies, which they were aware of and which 2 we discussed with their executives that they lower the 3 dose. And they chose not to. 4 But the issue in the design defect is could 5 they have. 6 they have made a prescription. 7 things to it. 8 shows the feasibility. 9 You have cited it in your own order. Could they have lowered the dose. Could Could they have added And the fact that they did it after That's one of our elements. And that's the 10 way it -- respectfully, that's the way it works in 11 this -- given that we're now in a design defect case. 12 MR. HEWES: I can't talk about design 13 defect and feasibility without talking about, at the 14 time that the product was manufactured, it was 15 ingested. 16 That continues to be ignored, number one. Number two, I recognize your order. Your 17 order is what it is. 18 facts considered for summary judgment purposes sort of 19 are considered in the light most favorable to the 20 nonruling. 21 a different standard for assessing a summary judgment 22 claim at that point versus actual admissibility at 23 trial, Your Honor. 24 up. 25 As we discussed last week, the It doesn't mean they are admissible. It's Again, we shouldn't mix those two So for the reasons I previously stated at Golkow Technologies, Inc. Page 210 August 31, 2015 1 deposition, Your Honor. 2 3 MR. MILLING: are you saying, "Mr. Hewes, it was not feasible" -- 4 5 MR. HEWES: 8 9 10 You should address the Court. Address the Court. 6 7 I guess my last comment is, MR. MILLING: -- "to reduce the dose before 2011?" THE COURT: It's feasibility as of the date that it's manufactured. There is a distinction between a summary judgment motion and where we are now. 11 And the defendants' motion is granted. 12 Number 10. Exclude evidence argument 13 regarding what the FDA may do in the future. 14 we already talked about that. 15 I think Apparently both -- you both believe the FDA 16 may do something in the future, but we're not going to 17 talk about it. 18 MR. MILLING: 19 THE COURT: 20 Exclude evidence or argument related to the Correct. So that motion's granted. 21 September 2002 and 2009 advisory committee meetings. 22 Tell me why I shouldn't grant that. 23 MR. TISI: Yeah. Your Honor, as I 24 understand it, there are kind of three categories of 25 evidence that they are seeking to preclude while at the Golkow Technologies, Inc. Page 211 August 31, 2015 1 same time seeking to introduce evidence from those very 2 same meetings to support them. 3 THE COURT: So the 2002 advisory -- That's not going to happen. 4 What's good for the goose is good for the gander. 5 you both want to introduce things from those reports, 6 then they'll live with the reports. 7 MR. TISI: If Yeah, well, these are the -- 8 we're talking about a 2002 advisory committee that was 9 codified in the 2006 proposed rule. And that would be 10 all the discussion about the risks and benefits and 11 different lines of evidence, case reports, case series, 12 you know, labeling needs to change, all those kinds of 13 things. 14 working group document which the Court cited in its 15 motion for summary judgment denial. 16 advisory committee which they were present at. We talked about the 2008 -- excuse me -- 2008 17 And the 2009 I want to really focus in on all of that. 18 Because this goes to the issue that we talked about 19 repeatedly throughout the past couple of days. 20 What happened with acetaminophen happened 21 over at least a decade, and multiple decades going back 22 to the 1970s. 23 24 25 THE COURT: You're talking about a couple generations. MR. TISI: Golkow Technologies, Inc. Correct. And -- but it really Page 212 August 31, 2015 1 got heated up in the 2000s. 2 advisory committees. 3 the AASLD. 4 There were several There was, as we talked about, We talked about different groups. And, you know, importantly, McNeil was part 5 of that whole thing. 6 closed doors. 7 They participated in every meeting. 8 it. 9 FDA, of the FDA advisory committee, the FDA working This wasn't happening behind They were present at every meeting. They reacted to And the reaction to the recommendations of the 10 group, the AASLD I would roll in there, is all really 11 important because those people were trying to tell 12 McNeil that the risk-benefit profile -- again, we're 13 going to the common denominator here in a few cases -- 14 was not what McNeil was saying it was. 15 Now, they come in for three reasons. First 16 of all, they are not hearsay at all. 17 notice. 18 notice of it. 19 things, 2002 advisory committee, the working group, and 20 the 2009 advisory committee. 21 purpose. 22 They come in for They were involved in the process. They reacted to it. They got All of these three So it comes in for that But these also come in as business records. 23 They meet all the elements as a business records 24 exception, and they come in as government records under 25 803.8. Golkow Technologies, Inc. Page 213 August 31, 2015 1 More so than that, it comes in as evidence 2 that experts can rely on under 703. 3 rely on, for example, case -- the evidence from the 4 2002 advisory committee, because the experts did, in 5 fact, do so. 6 We know experts And I would refer, and I have copies here, 7 of both Federal Registers from 2006 and 2009. 8 itself relied on the evidence produced at those 9 meetings. 10 The FDA FDA -- we know the AASLD relied on them. We know that McNeil relied on them. 11 So Rule 703 allows experts to rely on what 12 the consensus of the community is, what learned groups 13 come together to discuss, particularly when the 14 defendant is involved in those. 15 So, you know, Mr. Kott said in the 16 beginning -- and I wrote it down -- he said at least 17 three times in different arguments, "The FDA is all 18 over this case." 19 "The FDA is all over this case." 20 And they want to discuss those aspects of 21 what happened with the FDA that benefit them. 22 would like to discuss to put it in balance. 23 like to say, well, you know, the FDA may not have taken 24 a formal position yet on Issue X. 25 something, the FDA and its scientists and its advisory Golkow Technologies, Inc. And we We would But you know Page 214 August 31, 2015 1 committees have weighed in on this issue repeatedly 2 over the past five or six years. 3 You reacted to it. 4 could have rejected it, which you decided to do. 5 you could have accepted it and we wouldn't even be here 6 today. You know about it. You could have accepted it. 7 Okay. 8 presentation of the evidence. 9 quote, all over this case, or it is not. 10 You Or So we can't have a one-sided Either the FDA is, And if it's all over this case, the jury 11 should hear about their participation in the two 12 advisory committees and their understanding of and 13 their reaction -- their reaction to those events. 14 Importantly, it's -- you know, apart from 15 being woven into the fabric of this case, I must say 16 what is really important is that they did weigh in on 17 these issues when they participated in the 2002 18 meeting, when they weighed in in opposition to AASLD 19 working group. 20 They had every opportunity to convince the 21 FDA and the advisory committee that they were wrong, 22 and they were unable to do that. 23 evidence in this case that an expert can rely on. 24 25 That's important But, again, it comes in as business records. It comes in as government records, and it Golkow Technologies, Inc. Page 215 August 31, 2015 1 comes in for notice as well. 2 3 So there are multiple avenues in which this comes in, Judge. 4 MR. HEWES: Briefly, Your Honor. 5 THE COURT: Yes, Mr. Hewes. 6 MR. HEWES: First off, the Federal 7 Register, what's contained in the Federal Register is 8 required under statute for Your Honor to take judicial 9 notice of. 10 And that's a different issue. Moreover, the 2009 Federal Register issue 11 here predates the 2009 advisory committee. 12 suggest that those are interrelated somehow is 13 incorrect. 14 So to But I want to first talk about the actual 15 advisory committees themselves. 16 case, precedent after precedent after precedent has 17 found advisory committee testimony to be hearsay, to be 18 inadmissible hearsay. 19 Case after case after And Your Honor -- when Your Honor discussed 20 this about last year almost to the day, Your Honor 21 noted that advisory committee work is hearsay. 22 Honor suggested that you were going to exclude it based 23 on that. 24 25 Your As a matter of fact, the motion was granted. And then Your Honor went into a discussion of the 2008 working group. Golkow Technologies, Inc. And I re-read it again to Page 216 August 31, 2015 1 make sure I had it right. 2 when we discussed this in more detail on September 2nd 3 as to the working group, and I quote on Page 159, 4 Lines 23 through 24, "This is not going to get 5 presented to the jury for sure." 6 First off, Your Honor said, And Your Honor said it better than I can 7 say it. 8 makes more sense. I'll read what Your Honor said, because it 9 It says, "Here is my concern." This is you 10 talking, Your Honor. 11 removed and one step pre the advisory committee, and 12 the FDA never acted on the advisory committee. 13 we're trying to gussy this up to the jury. 14 agree, it's all learned people talking, learned people 15 having significant disagreements that the FDA has never 16 acted on." 17 "This study group is one step Page 20 to 183. So And I It's to Line 20 to 183 18 Line 2. 19 the study group's recommendations and the entire 20 discussion are a step removed from a step prior to the 21 advisory committee. 22 the opinion that's hearsay. 23 never acted on by the FDA." 24 25 Again, Page 187. The Court, Line 20: "Well, And the advisory committee, I'm of This is hearsay, hearsay And you went on to explain how a limiting charge would not be enough to unring this bell, Golkow Technologies, Inc. Page 217 August 31, 2015 1 basically, as to the hearsay and the hearsay problems 2 with it. 3 reasons previously stated, Your Honor, advisory 4 committee meetings are pure hearsay. 5 qualify under any type of exceptions. 6 detailed with that if Your Honor would like. 7 it's fully briefed. 8 conversations that were never subject to 9 cross-examination by a group of people who were 10 So for the reasons in our brief and the They don't I can get more We think They represent informal convened to discuss certain issues. 11 And as we discussed earlier, the issue 12 under Rule 703, experts rely on a lot of things, Your 13 Honor. 14 make them right. 15 something, that doesn't give them carte blanche to open 16 the door to discuss it substantively in front of a 17 jury. 18 It doesn't make them admissible. It doesn't And because an expert relies on And so I think 703.7 kind of bears that 19 out. 20 reasons Your Honor cited last year, we believe advisory 21 committee meetings as well as the -- 22 23 24 25 So for the reasons that we stated earlier, the THE COURT: Well, Mr. Tisi thinks you are going to be relying upon these yourself. MR. HEWES: If they are excluded, we're not going to be relying on them, Your Honor. Golkow Technologies, Inc. Are you? We have Page 218 August 31, 2015 1 enough in this case -- 2 THE COURT: He's smiling. 4 MR. HEWES: He's smiling because -- 5 THE COURT: Pull me into the loop. 3 Are you going to -- Is 6 there any plans that you are going to be relying upon 7 this information? 8 9 MR. HEWES: We will be relying on information based upon reliable scientific evidence as 10 to the safety of this drug. 11 reliable scientific evidence as to the efficacy of this 12 drug. 13 discussed at an advisory committee. 14 intend to cite any advisory committee opinions. 15 don't intend to cite any advisory committee testimony. 16 We don't intend to rely on that, Your Honor, because 17 hearsay is hearsay. We will be relying on And some of it may cross over as to what was 18 We don't ever We What we're talking about is the opinions of 19 the committee themselves and the discussions of the -- 20 the discussions of the committees themselves, 21 specifically focusing on the 2009 committee, because it 22 was a more active discussion. 23 rely or discuss any of the 2009 committee activities, 24 Your Honor. 25 MR. TISI: Golkow Technologies, Inc. So we don't intend to Your Honor, let me just address Page 219 August 31, 2015 1 the elephant in the room, if I could, your rulings of 2 last year. I'm going to be blunt. 3 The discussions that we had about that was 4 during the course -- you had originally denied it, but 5 we had a discussion of it while we were dealing with 6 deposition designations. 7 In those -- in those discussions, there was 8 no discussion about whether any of the evidence was -- 9 for example, let's take the working group -- whether or 10 not it was admissible for notice under 801. 11 no discussion about whether or not it met an exception 12 to the hearsay rule under 803.6 or 803.8. 13 There was There was no discussion about whether an 14 expert would rely upon it. 15 the context of as we were getting ready for trial and 16 dealing with the issues of that. 17 You were ruling on it in I think, candidly, if I could be so bold as 18 to say, I think you said we've learned a lot in the 19 past year. 20 recognizes, at least implicitly -- I mean, it didn't 21 rule on the admissibility of, for example, the working 22 group, but recognized the importance of this group of 23 people providing information, government employees 24 providing -- doing a formal report. 25 And I think that your ruling the other day And remember this formal report was to the Golkow Technologies, Inc. Page 220 August 31, 2015 1 commissioner of CDER. 2 report. 3 advisory committee and their position before the 4 advisory committee. 5 This is not some low-level It's provided by the FDA directly to the McNeil filed its own response to the 6 advisory committee, which presumably is the basis for a 7 lot of what they're talking about here. 8 9 So in fairness to everybody in this room, there was really not a discussion of whether or not 10 there was an exception involved, whether experts can 11 rely upon it. 12 So I think Mr. Hewes, respectfully, is 13 reading too much into the Court's comment that was made 14 during the course of -- during the course of a ruling 15 on deposition exception. 16 I have heard in this case -- moving on to 17 the next point about this, I have heard in this case 18 over and over, and we dealt with it with how the FDA 19 did this, the FDA did that. 20 Perfect example. Mr. Hewes got up here -- I forget what day 21 it was, but talked about the fact that when they 22 changed the four to six hours to the four hours, there 23 was a letter that was written from the FDA basically 24 telling them that it was okay to do it, change it to 25 four to six hours instead of four hours. Golkow Technologies, Inc. Page 221 August 31, 2015 1 They are not going -- they won't get beyond 2 the first sentence of their first -- of their opening 3 statement without mentioning the FDA. 4 recommend to us today that they're willing to take the 5 FDA out of the case entirely and the FDA is not going 6 to be mentioned at all in this case -- 7 THE COURT: 8 MR. TISI: 9 If they were to That's not going to happen. -- I would agree. know that's not going to happen. But we all So how could we have 10 a discussion about letters sent back and forth on 11 GRASE, memos back and forth to them on four to 12 six hours, you know, that the FDA did this in the 13 Federal Register, the FDA did that in the Federal 14 Register, but not have a discussion of a formal working 15 group document that was submitted to the commissioner 16 and was made part of the formal record at an advisory 17 committee? 18 I'm not going to suggest in any way that 19 the comments of the advisory committee come in. 20 hearsay. 21 is a government record. 22 note of their vote. 23 website for the FDA. 24 25 But the formal vote? That's The formal vote, that The federal government took They issued it. You can go on the The vote of that telling McNeil and everybody else that the dose should be lowered from Golkow Technologies, Inc. Page 222 August 31, 2015 1 4 grams to 3 grams, that Extra Strength Tylenol be 2 taken and be put behind the counter, that is a record 3 of a formal meeting of a government organization that's 4 provided by a statute. 5 That comes in. I'm not saying all the testimony of the 6 different advisors during the course of that meeting. 7 But the results of that meeting? 8 I'm trying to give a traffic board who has -- they have 9 a vote on whether to put a stoplight in. It's almost like a -- It may not be 10 binding on the county. 11 formally entered in the public record, it becomes part 12 of the record in the case. 13 14 But there's a board. If it's The vote of the advisory committee, the 2000 -- it's a government record. 15 The 2002 data that came in in the 2002 16 advisory committee was codified in the Code of Federal 17 Regulations. 18 they come in for the truth. 19 and experts can rely on them in Rule 703. 20 So these are all government records. MR. MILLING: So They come in for notice, If I may add, Your Honor, 21 just to put some factual context. 22 to tell the story of what happened to acetaminophen and 23 not talk about the 2002 and 2009 advisory committees 24 and all of the submissions. 25 of pages to the advisory committee that were Golkow Technologies, Inc. I think -- back up, McNeil submitted hundreds Page 223 August 31, 2015 1 disseminated to everybody on their position. 2 They received thousands of pages from all 3 the stakeholders on other people's positions. 4 attended these meetings. 5 They made representations at the meetings that we 6 certainly intend to cross-examine them on. 7 8 11 They spoke at the meetings. To make it even more clear, just tell them the story without the chapters. 9 10 They As the defendants relate, none of this happens. It's a lot of negative talk. The 2002 advisory committee -- the 12 defendants, actually, in their summary judgment motion, 13 you'll remember, they submitted all the FDA PowerPoints 14 as part of their exhibits. 15 scientist named Dr. Nourjah in front of McNeil and 16 everybody, did a summary. 17 The FDA stood up, and a And you've seen it. He looked at all the case studies, and he 18 discussed to the whole group, and he found that 19 10 percent of the cases in the FDA's database had 20 reported doses of under 10 grams. 21 Now, that's notice to McNeil of what the 22 FDA is saying they're seeing with this drug. 23 importantly, before that meeting -- and that 24 information was put in the Federal Register. 25 But, more Even in addition to that, before the Golkow Technologies, Inc. Page 224 August 31, 2015 1 meeting, McNeil went to the FDA and said, "We 2 understand that you're going to present these 286 cases 3 at the advisory committee." 4 this. Dr. Temple testified to "Can we look at them?" 5 And McNeil took the same cases and took 6 them down to Denver and had Dr. Dart and some of their 7 consultants look at some of those cases. 8 involved these advisory committees are. 9 This is how At 2009 advisory committee, Dr. Kuffner 10 stood on the -- and, by the way, these are transcribed 11 documents. 12 time. 13 These meetings are transcribed in real Dr. Kuffner stood up on behalf of McNeil 14 and said, "Today we are recommending changing 15 instructions for Extra Strength Tylenol from, 'Take two 16 tablets every four to six hours, to take one tablet 17 every four to six hours.'" 18 19 Called dose titration. It is a design change. They haven't done it. 20 That's -- they are talking. They are going 21 to stand up and say, "Our efficacy trials show X, Y, 22 and Z." 23 Christina Chang told them and gave them notice that, 24 from the FDA's position, their efficacy studies were 25 not very convincing. At the 2009 committee, the FDA itself, Golkow Technologies, Inc. They heard that. They've been Page 225 August 31, 2015 1 questioned about that. 2 them at deposition about how all this information is 3 taken -- is required to be taken into context of the 4 company in terms of its pharmacovigilance. 5 They were -- they talked with And so what's really happening here, 6 backing up, is these are major chapters in the 7 acetaminophen progression and the dialogue in the 8 scientific community. 9 the 2009 meeting. These are huge -- 37 advisors at That's a huge meeting. And 10 McNeil -- it's convened by statute. 11 they probably had a hundred meetings before this 12 advisory committee. 13 meetings. 14 questions and answers. 15 what they are going to tell people if somebody says 16 this. McNeil testified They do mock advisory committee It's like doing a mock trial. They do mock They write position papers on 17 Huge amount of information. For McNeil to stand up and say, "We just 18 want to extract these two monster pieces," one of which 19 is 2002, which led to the 2006 rule which is the 20 codification in the Federal Register of the 2002 21 advisory committee, one of which resulted in the 22 advisors saying this product is risky. 23 takes its position and all the stakeholders take 24 theirs. 25 And McNeil It would be like, you know, you writing a Golkow Technologies, Inc. Page 226 August 31, 2015 1 book and taking a couple of the major chapters out of 2 it and saying this is the whole story. 3 to the jury. 4 5 6 This goes to notice. That's not fair It's woven in the fabric of the case. THE COURT: My concern remains that I want 7 the jury to hear quality evidence, but the jury also 8 needs to hear the entire story. 9 there's going to be a certain amount of hearsay I don't have any doubt 10 evidence that's going to be introduced. 11 unlikely that we're going to be able to omit from the 12 presentation to the jury, and I think both sides are 13 going to have to, in part, rely upon some of the things 14 that were discussed by these advisory committee 15 meetings, because you find that some of those things 16 discussed are to your advantage. 17 And it seems All that said, I think I have to deny the 18 defendants' motion with the understanding that the 19 party coming forward with, you know, whatever they want 20 to cherry-pick out of these two study groups is going 21 to have a heavy burden of persuasion with me before the 22 jury hears about it. 23 24 25 I would start with you, because you're going to be the first ones that are going to do it. MR. MILLING: Golkow Technologies, Inc. Absolutely. And we're happy Page 227 August 31, 2015 1 to explain the relevance and the admissibility at the 2 proper time. 3 Thank you, Your Honor. THE COURT: Mr. Hewes, you can be heard, 4 but it seems to me the discussions between McNeil and 5 these study groups was quite involved. 6 MR. HEWES: The advisory committees, 7 yourself, Your Honor, the plaintiff referenced the FDA 8 interaction with McNeil. 9 with McNeil. 10 That's the FDA interacting That's not an advisory committee which is a second committee from the FDA. 11 There's no reference to any type of 12 advisory committee notes appearing in any type of 13 Federal Register. 14 15 THE COURT: submissions to the advisory committee? 16 17 18 19 20 Yeah, but did McNeil make MR. HEWES: Yeah, McNeil did make submissions. THE COURT: Yeah, in the hopes of persuading them. MR. HEWES: Yes, Your Honor, but the data 21 in the submissions to the advisory committee is the 22 same data that Mr. Jackson and Mr. Cohen presented in 23 terms of reliable scientific data. 24 presented outside and beyond the advisory -- 25 THE COURT: Golkow Technologies, Inc. That can be And that may be the way it has Page 228 August 31, 2015 1 to be done too. 2 MR. HEWES: 3 And I think just from a -- from a pure Yes, Your Honor. 4 hearsay point, just so I understand your ruling -- tell 5 me if I'm wrong, because I don't want to presume 6 anything as we prepare. 7 The advisory committee meetings -- the 8 advisory committee testimony and the presentations to 9 the advisory committee meeting, including the 2008 10 working group -- 11 THE COURT: They remain hearsay. How you 12 are going to cherry-pick those, I'm not sure. 13 results and the presentations and the exchanges between 14 the committee and McNeil, they seem like they're fair 15 game to me. 16 MR. KOTT: 17 MR. HEWES: I'm talking. 18 THE COURT: Let him finish. 19 MR. HEWES: Let me ask you this. But the And, Your Honor -- So the 20 votes and the suggestions by the 2008 working group, 21 which are recommended to the FDA and not adopted, those 22 are not going to come in? 23 THE COURT: No. If they took a formal 24 position and FDA responded to it, then why shouldn't 25 the jury know of these exchanges? Golkow Technologies, Inc. Page 229 August 31, 2015 1 MR. KOTT: 2 THE COURT: 3 MR. KOTT: I've got an answer. Go ahead. Because unlike the Federal 4 Rules, the New Jersey rules on business records and on 5 government records under Crispin versus Volkswagenwerk, 6 Bureau versus Prudential, I know the Court's aware of 7 it. 8 9 10 11 The conclusions don't come in. So if you have in a document a statistical study, there were eight people who lived on the block where the explosion occurred, that might come in. But the conclusion of the BUP or BPU as to 12 why the explosion would occur, under our appellate 13 division and Supreme Court cases, the embedded opinions 14 don't come in. 15 So I was with the Court, and the only 16 reason I stood up is because the Court said, "Well, 17 some of the testimony back and forth might come in." 18 And some of the back and forth, Your Honor -- 19 THE COURT: I'm most concerned about 20 exchanges that McNeil had with these committees. 21 Obviously, McNeil wasn't giving them information for 22 the heck of it. 23 They were trying to persuade them. MR. KOTT: And that's different than the 24 opinion reached and the conclusion reached by these 25 committees, recommended X that the FDA never did. Golkow Technologies, Inc. Page 230 August 31, 2015 1 That's my point. 2 Under New Jersey law, the way the rules of 3 evidence have been interpreted under the case law, when 4 we have embedded opinions, those are normally out. 5 THE COURT: Embedded -- you have a result, 6 and within that result are various opinions. 7 result is going to be admissible. 8 aren't going to be. 9 MR. TISI: The The opinions likely The difference between what 10 Mr. Kott is saying is a conclusion -- you know, 11 so-and-so ran the red light -- is different than 12 saying, "We recommend that the dose be lowered from 13 4 grams to 3 grams." 14 can choose to accept it. 15 But the truth of the matter is -- 16 THE COURT: That's a recommendation. They They can choose to reject it. Okay. Stop. Why wouldn't the 17 recommendation be presented to the jury after the 18 certain exchange between McNeil and the committee? 19 McNeil had an opportunity to make their pitch. 20 committee said, "Well, this is what we recommend." 21 The Then you circled it off and did what you 22 did. 23 hear chunks of exchanges of information, but we're 24 still going to get to the same place, which is the FDA 25 seems to do what it does, vis-à-vis McNeil, or And the FDA did what they did. Golkow Technologies, Inc. We're going to Page 231 August 31, 2015 1 vis-à-vis the manufacturer, without too much regard to 2 the input they are getting from, and I'll put it in 3 quotes, learned professionals. 4 regards to their expertise. 5 MR. HEWES: I'm sure they vary with I can give you two examples for 6 liability, and it comes down to a 403 issue, Your 7 Honor. 8 discussions made in the 2008 working group is the 9 recommendation and discussion that acute liver failure For instance, one of the recommendations and 10 can occur at or near a narrow therapeutic toxic dose. 11 And the basis for making that assertion is built on 12 adverse event reports. 13 events reports as the basis for making that assertion. In fact, they cite adverse 14 So we risk the jury from getting too much 15 weight or putting too much weight to a committee that 16 was never subject to cross-examination. 17 18 And I can give you a good example, Your Honor. May I approach? 19 THE COURT: 20 I'm sorry, guys. 21 bottom of the pyramid. 22 23 The adverse event reports are at the MR. TISI: Maybe. But it doesn't make them irrelevant, Judge. 24 25 That's a real problem for me. THE COURT: irrelevant. I'm not saying they're I'm saying they have to be scrutinized. Golkow Technologies, Inc. Page 232 August 31, 2015 1 MR. TISI: And the point is, Judge, what 2 was done here on page 12 -- and I wish I had it in 3 front of me, because it's a really important point. 4 The FDA advisory committee -- the working group, it 5 didn't just make this -- it didn't just make its 6 recommendations like willy-nilly and sit down in a 7 closet somewhere and did it. 8 by McNeil. 9 commend you to look at Page 11 and 12 of that report -- 10 it starts out saying that McNeil -- "one manufacturer," 11 and we know it's McNeil because it's footnoted -- it 12 says, "McNeil's submission to the advisory 13 committee" -- "suggests that you cannot make an 14 inference of causation," or whatever, "because case 15 reports are unreliable." It has formal submissions 16 And you'll see, if you look -- and I really Then it goes -- does exactly what we've 17 been saying for the past three times we've been before 18 you. 19 databases that support this. 20 through all that stuff. But there are clinical trials. 21 There are two Blah, blah. It goes Then it says -- on Page 12, it says, "Now 22 there are going to be those people," like McNeil, "who 23 say you can't rely on case reports because they are 24 unreliable." 25 that we think, on balance, we need to lower the dose. But the evidence is so overwhelming here Golkow Technologies, Inc. Page 233 August 31, 2015 1 2 That is exactly what our case is about, Judge. 3 I mean, they address Mr. Hewes's statements 4 directly, and it's directly by -- and I would just 5 point out, this was a recommendation of nine scientists 6 to the director of CDER, which is the Center for Drug 7 Evaluation and Research, and present it as the formal 8 FDA opinion to a statutorily created advisory committee 9 as the position of the FDA. 10 And it was presented as part of the background package to that. 11 So the fact that these scientists and the 12 FDA itself specifically rejected the very kind of 13 argument that this is low-level evidence that should be 14 disregarded, is just not true. 15 THE COURT: I have denied the motion with 16 the express understanding that plaintiffs are going to 17 have a significant burden to convince me that anything 18 that looks like hearsay is going to come in. 19 all been heard. 20 And we've So we're going to go to the next one. Exclude evidence or argument based upon 21 defendants' constitutional right to petition the 22 government. 23 Again, I think what I did with that last 24 time was granted it. 25 shouldn't grant it again. Golkow Technologies, Inc. And I don't see any reason why I Page 234 August 31, 2015 1 MR. MILLING: Your Honor, again, to use my 2 colleague Mr. Tisi's statement, to be so bold, I think 3 we've come a long time -- a long way. 4 all due respect, we were trying to process a lot of 5 information -- 6 THE COURT: Last year, with And I've read all that stuff 7 again in the submissions. 8 talking about a conversation at a golf course. 9 MR. MILLING: 10 No, no, no. That's Kennedy. I'm talking -- I think the more important 11 is, McNeil can lobby. 12 that's fine. 13 I'm saying to myself, we are I can lobby. We can lobby, and However -THE COURT: That's how this process works. 14 For better or for worse, that's how the FDA is set up 15 and Congress is set up. 16 MR. MILLING: We know after the 2009 17 advisory vote to recommend to take Extra Strength 18 Tylenol off of OTC, the board of directors of Johnson & 19 Johnson convened a meeting at which Dr. Kuffner 20 testified, as you've seen the documents called SATAC. 21 And the goal of SATAC, as is in the PowerPoint 22 presentation, was to influence the FDA to keep Extra 23 Strength on the market. 24 25 And it went through, and it said the reason -- "Here is how we're going to do it. Golkow Technologies, Inc. We're Page 235 August 31, 2015 1 going to involve key opinion leaders, and we're going 2 to get them to help us influence the FDA to disregard 3 what the advisors said." 4 And what they did was they said -- they 5 identified the senators, the representatives, on a 6 specific issue. 7 Johnson documents about "We have been in contact with 8 the White House on this issue, the Office of Management 9 and Budget on this issue." 10 And then there's also Johnson & And so this petitioning of the government 11 is not just petitioning of the government. 12 right to what the heart of this case is, saving Extra 13 Strength Tylenol, their billion-dollar product, that 14 had been recommended, because of this narrow safety 15 margin, to be put prescription. 16 And that is directly relevant to motive. 17 It's right in the fabric of the case. 18 intent. 19 20 It goes THE COURT: It goes to the How do you propose getting this evidence in? 21 MR. TISI: 22 MR. MILLING: Through Dr. Kuffner. We have a 30(b)(6) on the 23 entire issue. 24 discussed through the company. 25 This meeting has been discussed. The corporate conduct has already been Golkow Technologies, Inc. It's been acknowledged. The PowerPoint has Page 236 August 31, 2015 1 been discussed, the influencing the FDA. 2 Dr. Kuffner's testimony. 3 4 THE COURT: Are you going to call Dr. Kuffner? 5 6 It's right in MR. MILLING: Yes. By video. It's already done. 7 MR. TISI: And I would point out, Judge, 8 that you've heard it from Mr. Hewes a couple of times. 9 My friend, Mr. Hewes, I don't mean to be pointing it 10 directly at him. 11 couple times that the FDA did nothing. 12 be left holding the bag as to why that is. 13 You've heard from the defense a We're going to And the jury may come to the conclusion, as 14 maybe some people in this room will come to the 15 conclusion, maybe it was not warranted. 16 But the jury should also understand that 17 there are other reasons why the FDA may not have moved 18 on certain issues. 19 lobbied. 20 constitutional right to lobby the government. 21 course they do. 22 it's a constitutional right doesn't mean they're immune 23 from their actions. 24 25 One would be that they were We're not saying that they don't have a Of But that doesn't mean -- just because I have a constitutional right to do a lot of things, but I'm sure that if I was in court I would Golkow Technologies, Inc. Page 237 August 31, 2015 1 be, you know -- my conduct, even if it's protected by 2 the Constitution, would be relevant on certain issues. 3 They have a right to go to the government. 4 They have a right to go to Congress and say the FDA is 5 off the tracks here. 6 things. 7 They have a right to do a lot of But in a court, we're going to be called 8 upon to explain to the members of the jury why the FDA 9 hasn't acted. And part of the reason why the FDA 10 hasn't acted is because they have done a lot of work 11 before Ms. Taylor and before Ms. Jackson, and they've 12 done a lot of work to try and make sure it stays on the 13 market. 14 truth, that is the truth. That's the truth. I mean, if we go to the 15 And we shouldn't be put in a position where 16 we have a warped sense of the truth when we have a guy, 17 a 30(b)(6) executive of the company, testifying that 18 that's what, in fact, they did. 19 THE COURT: Mr. Hewes or Mr. Kott? 20 MR. HEWES: The more learned lawyer. 21 MR. KOTT: I hear so much today, offers of 22 proof. 23 And we're trying a design defect case. 24 motive. 25 all. And I have to come back to what we're trying. I heard about Motive is not in any element of this case at Golkow Technologies, Inc. Page 238 August 31, 2015 1 2 The corporate state of mind is not an element. 3 If our product is defective, we could have 4 the worst corporate state of mind or the best. 5 going to be liable if there is a reasonable, safer, 6 alternative design under the risk-utility factors. We're 7 So that's the proffer. 8 Mr. Tisi says, well, they have a right to 9 petition the government, without Mr. Tisi talking about 10 a case he knows very Well, United States Supreme Court 11 case Noerr, N-O-E-R-R, v. Pennington. 12 Court, it's this case. 13 not even a product liability. U.S. Supreme Well, it is not a Tylenol case, 14 The U.S. Supreme Court said the defendant 15 may not in any way, shape, or form be held liable for 16 anything to do with petitioning the government because 17 that is a First Amendment right. 18 applied -- I think it's Page 3 in our brief -- Noerr 19 has been applied three or four times in New Jersey to a 20 variety of cases. 21 And Noerr has been So my argument is, number one, motive, 22 corporate state of mind, none of those things are 23 relevant. 24 25 And, number two, even if they were relevant under Noerr, Pennington, and under appellate division Golkow Technologies, Inc. Page 239 August 31, 2015 1 cases, we could never have bad stuff come to us because 2 we exercised our First Amendment right to petition the 3 government. 4 MR. MILLING: Your Honor, we addressed that 5 case, and we distinguished it in our briefs. 6 United States Supreme Court case dealt with a claim 7 dealing with a right to petition government. 8 at all what we're talking about here. 9 That It's not We're talking about the course of conduct 10 of this company as it relates to either changing the 11 warnings or changing the design of Extra Strength 12 Tylenol. 13 the jury -- as Mr. Tisi said, why Extra Strength 14 Tylenol is still on the market, at least an explanation 15 for it. 16 and a PowerPoint that absolutely says "influence the 17 FDA." 18 And the defendants, we're entitled to show And we have one witness who talked about it, THE COURT: The defendants' motion is 19 granted. 20 may want to revisit it. 21 and evaluate it more carefully then. 22 the defendants' motion is granted. 23 I do want to see the Kuffner deposition. MR. TISI: I will look at the deposition But right now, Are they going to -- I ask this 24 of the Court for clarification. 25 able to stand before the jury and say the FDA never Golkow Technologies, Inc. I Are they going to be Page 240 August 31, 2015 1 acted? Because if they do -- 2 3 THE COURT: I'll have a better feel for that after I hear what Kuffner has to say. 4 MR. MILLING: Dr. Kuffner talked about a 5 lot of issues. 6 that talks about petitioning the government, which I 7 believe would be the part which is all that's being 8 asked to be addressed. 9 THE COURT: It was just one part of the PowerPoint As a general proposition, 10 people should never be penalized by exercising their 11 First Amendment rights. 12 MR. TISI: 13 THE COURT: 14 Of course not. Well, that's what you would hope to do. 15 MR. TISI: 16 THE COURT: No, no. You would like to take 17 Kuffner's deposition and beat him over the head with 18 it. 19 it. And what I need to do is see it. 20 So let me see MR. TISI: Just to be clear, I don't want 22 THE COURT: We'll make a time for certain 23 where I get to see it. 21 to beat -- 24 25 MR. TISI: the head. I don't want to beat anyone over I just want to provide the jury with an Golkow Technologies, Inc. Page 241 August 31, 2015 1 explanation as to why the -- 2 THE COURT: 3 the head. 4 to see it. 5 Maybe he needs to be beat over What do I know? Okay. I need to hear it. I need Number 13, exclude evidence, 6 argument related to foreign labeling or regulatory 7 actions. 8 Why shouldn't I grant that? 9 MR. MILLING: 10 we're not interested in foreign regulatory documents. 11 12 Your Honor, first of all, THE COURT: So then you don't have any problem with me granting it. 13 MR. MILLING: No. But we do believe that 14 the Canadian label, which is the only thing we're 15 talking about, should be shown to the jury, because, in 16 Canada, the label says severe or possibly fatal liver 17 damage. 18 Tylenol are warned about the potential fatality 19 involved in this case and as to the seriousness of the 20 injury. So Canadian citizens with Extra Strength 21 In the United States, they are not. 22 In the Canadian label, it is relevant to 23 show the adequacy of the United States label, because 24 we know before 2009, from 1988 to the present, McNeil 25 was free under the tentative final monograph, until the Golkow Technologies, Inc. Page 242 August 31, 2015 1 final rule came down, to put anything they want to. 2 And they put in Canada one label to warn 3 those citizens. 4 weaker label. 5 there if they didn't believe that it was a risk of the 6 product. 7 And in the United States, they put a And they wouldn't have put that label on And in our brief, Your Honor, we've cited 8 literally a host of cases where courts have repeatedly 9 and repeatedly allowed the use of foreign labels in 10 order to show the state of the company's knowledge of 11 the risks. 12 Beecham, which involved Paxil. 13 foreign label was relevant to the defendant's knowledge 14 of the potential side effects resulting in Paxil. 15 We cite the Tobin versus SmithKline In Re Fosamax. That held that the Persuad versus J&J. In Re 16 Yasmin. 17 Tobin versus SmithKline Beecham, the foreign product 18 labeling is relevant evidence as it may potentially 19 demonstrate the defendant's knowledge of a potential 20 side effect. 21 In Re Levaquin. Robinson versus McNeil. We cite in Robinson versus McNeil, this 22 very defendant, denied motion to exclude foreign label 23 in regulatory action to the extent that it's used to 24 establish knowledge. 25 motion to exclude -- denied motion to exclude foreign Golkow Technologies, Inc. Galdi versus Bayer. Denied Page 243 August 31, 2015 1 labeling. 2 And so I think there's about 20 cases that 3 are cited in our brief in which courts have considered 4 this issue and have said that it's relevant to 5 knowledge. 6 And I think it would be a different 7 analysis, quite frankly, if this was a prescription 8 product. 9 courts have allowed it. 10 But even in prescription products, these But this case, respectfully, this is an 11 easier decision because we're dealing with an OTC 12 product under the monograph system. 13 14 THE COURT: Do your exhibits include the Canadian warning? 15 MR. MILLING: Yes. The Canadian warning, 16 there's actually a website called Tylenol Canada. 17 can pull it up. 18 THE COURT: You I want to reserve a decision on 19 that, because I do want to look at the Canadian -- I'm 20 thinking what's on the American label -- I mean, you 21 even got an 800 number. 22 talking about the average person, right? 23 Liver. 24 much. 25 okay; that's no big deal. You talk about -- we're Liver. You're going to hurt your liver if you take too You have to be an idiot to think, Oh, well, it's Golkow Technologies, Inc. Think it through with me, Page 244 August 31, 2015 1 will you, please? 2 You -- implicit in your argument is the 3 average person is really stupid. 4 argument is the average person is really stupid. 5 MR. TISI: 6 THE COURT: Implicit in your No, I don't think so. And we've got to make sure. 7 See, I don't know where you are going with some 8 warnings. 9 here if you have a problem. The warning even has a 800 number. Call I don't know what more -- 10 we live in a society where people don't read, and you 11 can -- and I fear we're going to give them too much, 12 like we were talking about this morning around 9:30. 13 We talk about giving them too much in the way of a 14 warning, and they won't read that either. 15 MR. TISI: If you can design out the 16 problem, you design out the problem. 17 case is about, number one. 18 Number two is -- 19 THE COURT: 20 21 22 23 That's what this We're still talking about the reasonable person. MR. TISI: I agree with you. You know, Judge, it's a funny thing. THE COURT: I do want to look at the 24 Canadian label. 25 reserving a decision on that. I do want to compare the two. Golkow Technologies, Inc. I'm Page 245 August 31, 2015 1 2 It's 10 after 3:00. We need to move on to the next one. 3 Marketing and promotional materials. 4 Mr. Kott, tell me why I shouldn't deny that motion, 5 because that's a big part of what this case is about. 6 MR. MAYES: Your Honor, I think you'll 7 understand perhaps more why we filed this motion after 8 you've gone through some of the deposition 9 designations. 10 The amount of marketing evidence that the 11 plaintiffs are trying to introduce spans back decades. 12 All of it is offered to establish something that we 13 don't really dispute; that is, by and large, none of 14 the Tylenol advertising, whether it be for Tylenol 15 products generally or specific to a specific strength, 16 none of them list off the litany of risks that you hear 17 in prescription drug commercials, because those 18 companies are required to have risk information in 19 their advertising because they are governed by the FDA 20 as it relates to advertising. 21 Over-the-counter products are governed by 22 the FTC. 23 advertising be truthful and not misleading. 24 to you that, particularly in these two cases, where we 25 have no evidence that either plaintiff relied on any All that is required is a statement that Golkow Technologies, Inc. We submit Page 246 August 31, 2015 1 advertising in making their decisions to take Tylenol. 2 3 THE COURT: Hold on. the concern that I have. 4 I need to hear from the plaintiff. 5 marketing is very relevant here. 6 she rely upon marketing? 7 MR. MILLING: 8 9 Now you're raising it. I think To what extent did Your Honor, I will address First of all -THE COURT: Because I'm generally inclined 10 to deny their motion. 11 put up a whole bunch of history about marketing that 12 never influenced this lady. 13 facts of the plaintiff, don't we? 14 But that doesn't mean you get to MR. MILLING: We have to stay to the Actually, there are many, 15 many cases that we cited in our brief where the courts 16 have dealt with decades-long significant national and 17 international marketing campaigns and have decided that 18 the evidence comes in, even though a prescribing 19 physician in a prescription case or a plaintiff in an 20 OTC case, but they are mostly prescription cases, and 21 we cite the case of Barton versus Wyeth 22 Pharmaceuticals. 23 It's a hormone therapy breast cancer case. 24 The appellate court affirmed the admission of evidence 25 to defendant's marketing practice, even though the Golkow Technologies, Inc. Page 247 August 31, 2015 1 prescribing physician testified his prescription was 2 not based on any specific marketing he could pinpoint. 3 It was just based on the global marketing that had gone 4 on. 5 We cite the case, Hon versus Stroh Brewery. 6 "Evidence of a manufacturer's attempt to cultivate 7 belief among the consuming public that moderate 8 consumption of a product is safe is relevant to a 9 defective product case even if it didn't rely on it." 10 That goes to your first question. 11 But the real issue is, is marketing 12 relevant to this case. 13 I would suggest that it absolutely should be denied. 14 In fact, in your own order, this is a design defect 15 case, and you say in your order -- 16 THE COURT: And you're inclined to deny it. Yes, I'm denying their motion. 17 But I'm also alerting you that you need to show me what 18 it is that you want to propose in marketing. 19 prevailed. 20 MR. MAYES: So you Two quick questions, Your 21 Honor. 22 information was relevant, you indicated that they were 23 required that they come forward with that evidence 24 before the trial starts -- 25 Last year when you ruled that marketing THE COURT: Golkow Technologies, Inc. And that's what I'm telling Page 248 August 31, 2015 1 them now. 2 MR. MAYES: Okay. And the second part of 3 their response to the motion talks specifically about 4 getting into evidence the amount of money McNeil -- 5 dollar figures that McNeil spent on its marketing and 6 promotional materials for its Tylenol brand. 7 like the same protection we asked for as it related to 8 profit margins and sales numbers, that the amount of 9 money that we spent on marketing of Tylenol products We would 10 should not come into evidence because it's not relevant 11 and it's highly prejudicial. 12 MR. MILLING: Your Honor, as the Court 13 knows, this brand, this case is being tried, it's very 14 interesting. 15 America. This is one of the most iconic brands in 16 THE COURT: 17 MR. MILLING: It is. It's apple pie and Chevrolet 18 that's on trial. 19 be clear, it's not even a brand. 20 that, through marketing, McNeil has convinced people, 21 or Johnson & Johnson, that it's a brand. 22 brand. 23 And the reason it is -- in fact, to It is a generic drug It's not a It's a generic. And it was done that way through 24 sophisticated marketing by getting -- through the 25 slogan, "Number one trusted by doctors," marketed on Golkow Technologies, Inc. Page 249 August 31, 2015 1 the basis of safety. 2 the defendants' witnesses have all testified that even 3 if they can't remember specific commercials, what they 4 remember is the gist of the marketing over their life, 5 that this is a safe and trustworthy brand that doctors 6 recommend most. 7 And the plaintiff will testify, It's even on the box. THE COURT: The defendants' motion has been 8 denied, and we will talk more about what I'm going to 9 commit in the way of marketing materials. 10 Let's go to 15, exclude media reports 11 relating to Tylenol. 12 think of. 13 That is rank hearsay that I can MR. MILLING: I think, Your Honor, you are 14 exactly right. 15 like Dr. Kuffner is on the stand and he may have made a 16 statement, I think we might be entitled to 17 cross-examine him with the statement. 18 intend to try this case on media reports. 19 Except to the extent that a witness THE COURT: But we do not Well, the motion's granted. 20 And if at some point we've got a particular witness 21 that has been quoted, we'll have a 104 hearing first, 22 because the witness may say, "That's absolute utter 23 nonsense," and that's the same thing that he said in an 24 earlier deposition, and there's never been anything to 25 contradict the witness or support the article. Golkow Technologies, Inc. I don't Page 250 August 31, 2015 1 know where we go with it. 2 But the answer to that is, their motion's 3 granted and we'll deal with it case by case. 4 think there's some pressing media report that we need 5 to talk about -- 6 MR. HORN: If you That's fine, Your Honor. Just 7 as a slightly broader issue, I think what we're seeking 8 to do is not just impeach a specific witness, but a 9 comment they might have made in the media. But, 10 hypothetically, if a witness says something about 11 corporate conduct, what they knew, that would be 12 contradicted by a general media article that they put 13 out. 14 impeachment. 15 That's broader impeachment, but that's still THE COURT: 16 like a press release? 17 MR. HORN: 18 they helped generate. Hold on. That McNeil put out Yeah, a press release. Media 19 THE COURT: 20 for cross-examination. 21 release to contradict something said now in this 22 courtroom, it's fair game. Of course. That's fair game If McNeil put out a press 23 Exclude evidence and argument related to 24 statements submitted to the American Association for 25 the Study of Liver Disease to the FDA and a 2006 press Golkow Technologies, Inc. Page 251 August 31, 2015 1 release issued by the American Liver Foundation. 2 Again, that falls within the category of a 3 lot of things we've talked about. I don't know who is 4 going to try to use what portion. Again, we're talking 5 about hearsay, but embedded in that hearsay may be some 6 important facts. 7 may be some final statements that each side is going to 8 want to try to take advantage of. 9 There may be some conclusions. There I'm neither going to grant nor deny that. 10 We're going to have to deal with this information as we 11 go forward. 12 MR. TISI: 13 THE COURT: 14 already talked about risk factors. 15 have not ruled on that. 16 carefully. 17 Thank you. Exclude testimony -- again, we And I told you I I'm going to look at it more For now, how I've ruled on it is, 18 plaintiffs' two motions are denied. 19 two motions are granted. 20 issue. 21 MR. TISI: 22 THE COURT: The defendants' But I am going to revisit the That's all we ask. Mr. Tisi and Mr. Horn and 23 Mr. Milling, I am concerned about the relevancy of all 24 that. 25 now I'm not persuaded that the jury should be hearing And I need to look at it more carefully. Golkow Technologies, Inc. Right Page 252 August 31, 2015 1 about alcoholics and people who are fasting. 2 sure where we go with that. 3 4 to the death certificate. MR. HORN: 6 THE COURT: Where are we with that? One second, Your Honor. Yeah, this is on whether or not she died of sepsis or acetaminophen poisoning. 8 9 We'll talk about it again. 18, exclude evidence and argument related 5 7 I'm not MR. HORN: Yes, Your Honor. It's argument that should be admissible for a number of reasons. 10 Number one, it's a medical record. 11 as a medical record along with the rest of her file. 12 It's part of her hospital chart. 13 14 It should come in Number two, it was an official medical document signed -- 15 THE COURT: I tend to agree with you. It's 16 going to be up to the defense to, you know, show why 17 the -- one witness -- the witness, the guy who prepared 18 it, already recanted, right? 19 MR. MAYES: Yeah, I took the deposition -- 20 THE COURT: You are going to use a 21 certificate, and the guy who prepared it says it ain't 22 right. 23 MR. MILLING: Actually, at one point, he 24 said that "I prepared it with legal medical certainty." 25 Then Mr. Mayes, very skilled lawyer, got him to say, Golkow Technologies, Inc. Page 253 August 31, 2015 1 "Well, you know what, I'm going to" -- 2 THE COURT: 3 MR. HORN: Go ahead, Mr. Horn. Yes, Your Honor. The way he's 4 described it is how it should play out. 5 in and they get to cross-examine on it, and let the 6 jury do what the jury will do. 7 MR. MAYES: It should come Yeah, the fact of the matter is 8 Dr. Gebetsberger is the one who filled out the death 9 certificate. Never provided any medical care and 10 treatment to Ms. Taylor. 11 while she was in the hospital. 12 she was already dead, if not a couple of minutes away 13 from death. 14 He didn't see her at all When he first saw her, She was totally comatose. He noted on the death certificate that he 15 was not her attending physician. 16 at the time of death. 17 acetaminophen toxicity as being the cause of her death. 18 He said he would defer to the people that did treat 19 her. 20 make that decision at his deposition. 21 He was just present He said he had no confidence in He said that he didn't have enough information to He said, even after having reviewed her 22 medical records in preparation for his deposition, he 23 was unable to tell us at his deposition what, in his 24 opinion, caused her death. 25 So for one document that he never knew Golkow Technologies, Inc. Page 254 August 31, 2015 1 would be utilized by plaintiffs' lawyers in the future 2 to establish a causal relationship between Tylenol and 3 Mrs. Taylor's death, when he himself has indicated that 4 he had no basis to offer that opinion. 5 THE COURT: It's certainly a public record 6 that I'm obligated to take notice of. 7 going to get the opportunity to share why the guy who 8 made it is not sure anymore. 9 MR. HORN: That's fine, Your Honor. 10 course, they can cross-examine. 11 Court -- 12 THE COURT: 13 MR. HORN: Also, they are Of Just to update the I'm not going to exclude it. I just wanted to inform Your 14 Honor, I think this is going to develop further. 15 is -- this doctor will be one of the people that will 16 be deposed in the upcoming weeks. 17 be fleshed out further and we'll know more at the time, 18 but -- 19 20 THE COURT: This I imagine this will But he was deposed already, right? 21 MR. HORN: In a discovery deposition. 22 THE COURT: Deposed on your notice? 23 MR. MAYES: Yes. 24 MR. KOTT: 25 This is what I've learned. In two of the depositions, the plaintiffs questioned Golkow Technologies, Inc. Page 255 August 31, 2015 1 first. 2 very short, the one we are talking about now. 3 a couple hours. The Court asked how long they were. 4 One was One was Those two were not videotaped. So it's our position on the two where they 5 questioned first under the court rule, they don't get 6 to -- and I think I'm right -- they don't get to -- 7 THE COURT: I would like to see these 8 depositions be done by video. 9 they? 10 MR. HORN: 11 Your Honor. 12 counsel said -THE COURT: It is true what The two that were done by video, did you do the initial questioning? 15 16 Two of them were done by video, Two of them were not. 13 14 But they weren't, were MR. HORN: It wasn't me, Your Honor. I don't believe they were -- 17 THE COURT: But plaintiffs did? 18 MR. MAYES: Four depositions were taken. 19 They agree one does not need to be retaken. 20 want to retake three of them, two of which they noticed 21 and didn't videotape, one of which we noticed and did 22 videotape. 23 MR. HORN: So they The witnesses are not 24 unavailable. 25 for a variety of reasons we never figured out. They are agreeing to testify, one of them Golkow Technologies, Inc. Page 256 August 31, 2015 1 2 THE COURT: But you already took their deposition. 3 MR. HORN: But they were done in a 4 discovery deposition before we had a full set of 5 medical records. 6 records at the deposition. We didn't know about the medical 7 MR. MAYES: 8 medical records were well in hand. 9 MR. HORN: That's not true. Let me finish. All the Counsel had 10 records that we didn't have at the deposition. 11 blaming anyone. 12 fact. I don't know what happened. I'm not It's a You can laugh all you want. 13 Bottom line, Your Honor, this is what 14 happened. 15 hear a full-blown -- We think the jury should have the right to 16 THE COURT: I do too. I'm not going to 17 prejudice the plaintiffs' ability to put on their case. 18 It's possible that Mr. Mayes had records that Mr. Horn 19 didn't. That concerns me a great deal. 20 MR. HORN: I wasn't making accusations, 21 Your Honor. 22 that we were there, and it did happen. 23 deposition will give us a chance to explore records 24 that we simply didn't have at the time. 25 willing to testify. I don't know how it happened. Golkow Technologies, Inc. I just know We can schedule it. The second They're The jury will Page 257 August 31, 2015 1 have the benefit of hearing a full-blown, proper trial 2 preservation deposition on videotaped testimony, which 3 will benefit everyone, which as of now they don't have. 4 I don't understand how this prejudices the 5 defendants to do it again. 6 full opportunity to question as much or as little as 7 they choose with whatever document they choose. 8 will be a proper direct this time with proper 9 credentials done, a proper narrative. They're going to have a 10 everyone. 11 And that's where we stand, Your Honor. It It benefits And I don't see how it prejudices anyone. 12 MR. MAYES: The only thing I would add to 13 that -- it sounds like you are going to make your 14 decision. 15 July 15th. 16 having asked him to set these up. 17 like he's going to have -- be successful in dictating 18 scheduling issues during a pretty critical time when 19 we're getting ready to try another case. But we requested that these be set up 20 We are now almost to September 1st after So that's my complaint of the day. 21 this be done July 15th. 22 it hasn't -- 23 And now it sounds MR. HORN: I asked Now we are in September, and Your Honor, if you'd like, I'm 24 happy to show you e-mails and phone calls that have 25 gone back and forth with the risk office at the Golkow Technologies, Inc. Page 258 August 31, 2015 1 hospital. 2 THE COURT: 3 MR. KOTT: 4 THE COURT: That's not necessary. May I be heard? I'm going to exclude the death 5 certificate. 6 But now we are talking about the witness. And the witness will be cross-examined. 7 Mr. Kott wants to be heard. 8 MR. KOTT: 9 10 exclude the death certificate, did you intend to say that? 11 12 I hate to hurt my client, but to THE COURT: No, no, I'm going to deny the motion to exclude. 13 MR. KOTT: Our alternative really would be 14 that the conclusion as to the cause of death be 15 redacted. 16 Prudential. 17 moment. And I would rely on Biro, B-I-R-O, versus I'll give the court the cite to that in a 110 N.J. Super. 391, pages 402 to 406. 18 THE COURT: 19 MR. KOTT: Did you say 301? 391. It's an appellate division 20 decision that is reversed on other grounds at 57 N.J. 21 204, 1970. 22 But it comes back to the point I made 23 before, the document is a government record. 24 the date of death and the things that are -- I don't 25 remember. As far as But the document has her weight on it, date Golkow Technologies, Inc. Page 259 August 31, 2015 1 of death, hair color, whatever it has. 2 comments goes through this, talks about what he calls 3 embedded opinions. 4 Biro in his And so, therefore, not fighting with the 5 Court's ruling, you said you are going to admit it. 6 have an alternative request, and that is that the Court 7 redact the cause of death. 8 my friends over here, who some are not from New 9 Jersey -- this is a little bit where federal law and 10 And, again, this is where New Jersey state law diverge. 11 12 I MR. HORN: I didn't hear counsel state the reason why the cause of death should be redacted. 13 THE COURT: Because the preparer recanted, 14 didn't he? 15 don't want me to ignore that, do you? 16 I mean, that's a problem, isn't it? MR. HORN: You Well, number one, Your Honor, if 17 you even want to discuss that, why don't we wait until 18 after the deposition takes place to see what he says at 19 the next deposition. 20 Number two, I'm happy to send you the 21 transcript, Your Honor, and you can read them as you 22 wish. 23 anything, he deferred to another colleague. 24 25 We do not recommend it as recanting. If Nevertheless, the document stands on its own. The proper remedy is for them to cross-examine Golkow Technologies, Inc. Page 260 August 31, 2015 1 and make the doctor look bad, make us look bad for 2 trying to mislead the jury, whatever -- any way they 3 want to play it. 4 not to just to start selectively taking information out 5 of a document. 6 But that's the remedy. THE COURT: The remedy is I'm not going to rule on that 7 now. 8 And what use gets made of it, we'll determine after I 9 get a chance to see it and know more about the 10 11 12 13 All I'm doing is excluding the death certificate. testimony. Exclude certain inadmissible testimony of fact witnesses. That's a pretty broad one. MR. MAYES: That is specifically, narrowly 14 confined to a statement that Mr. Taylor testified in 15 his deposition was said to him by an unidentified 16 healthcare provider that, quote, if there were ever a 17 class action, a lawsuit against the makers of Tylenol, 18 you should be the first in line. 19 That's what he claims some healthcare 20 provider told him. 21 It's totally hearsay. 22 And it's clearly inflammatory. THE COURT: It sounds like hearsay to me. 23 I'm not going to worry about that kind of testimony. 24 It's not going to come in. 25 MR. HORN: Golkow Technologies, Inc. Given his example -- I understand, Your Honor. It's Page 261 August 31, 2015 1 our position this would come in under a number of 2 exceptions to show why the Taylors began to think about 3 Tylenol as an issue, as excited utterance. 4 importantly, not even for the truth. 5 there to say -- Mr. Taylor wouldn't say this doctor was 6 telling the truth when he said it. 7 saying it to say, in fact, the ultimate diagnosis was 8 Tylenol. But, more I mean, he wasn't Or he wouldn't be 9 He couldn't say that as a layman anyway. 10 So he actually couldn't make the statement as a true 11 statement. 12 13 THE COURT: Did he give you the name of the doctor? 14 MR. HORN: No, he did not. I understand 15 that's not a great fact for us. 16 change the fact -- and that's great cross. 17 THE COURT: 18 MR. HORN: However, it doesn't Pretty good. It doesn't change the fact that 19 he -- this witness could not use that statement for the 20 truth. 21 part of the narrative, say, "This is why we began to 22 think Tylenol was a problem." 23 24 25 He's not equipped to. THE COURT: All he can do is, as It's so self-serving. It falls all over itself. MR. HORN: Golkow Technologies, Inc. That sounds like pretty good Page 262 August 31, 2015 1 cross-examination, Judge. 2 the weight. 3 4 THE COURT: So it's argument; it goes to If that's the testimony you're alluding to here, I'm not going to permit it. 5 Okay. 6 Now, we're going to take -- it's almost That concludes Taylor. 7 3:30. 8 enough time to go to the bathroom, and we'll get back 9 and get this done. 10 How about if we resume at 3:40? THE CLERK: 11 Give everybody All rise. (Short break.) 12 THE CLERK: Remain seated and come to 14 THE COURT: Let's go back to our list. 15 And some of these we might be able to work 13 order. 16 through pretty quickly, because on Jackson, the first 17 thing we start with is adverse event reports. 18 motion is denied. 19 burden that they've got in terms of doing anything with 20 them. 21 Okay. And that But, again, plaintiff knows the The next item is draft documents. 22 And, again, that motion is granted. 23 mean that there won't be documents that will come into 24 play, depending upon what a witness says and how they 25 may be cross-examined. Golkow Technologies, Inc. But that doesn't Page 263 August 31, 2015 1 Number three, exclude evidence or argument 2 relating to profits. 3 granted without prejudice. 4 we want to look at that. 5 again, when I grant it without prejudice, that lets the 6 plaintiff know that, you know, they've got the burden. 7 And, again, that motion was There may be a reason why If we have to, we will. But, Four, exclude evidence or argument relating 8 to employee compensation. 9 granted. 10 And, again, that one is Although we said -- was it Dr. Temple? MR. MILLING: We said, Your Honor, that we 11 could mention that employees receive compensation, not 12 the amount, with the exception going to Dr. Temple. 13 THE COURT: Yeah. That there was one 14 witness in particular you said you might want to talk 15 about? 16 MR. MILLING: Dr. Temple is the one who's a 17 consultant still with a contract on an hourly basis for 18 litigation services. 19 20 21 THE COURT: We probably could talk about his hourly rate. Again, defendants' state of mind, that 22 motion's granted, again, without prejudice, because you 23 said there may be certain things that you can show 24 based upon documents that you produced in discovery. 25 So that was number five. Golkow Technologies, Inc. Exclude opinion Page 264 August 31, 2015 1 testimony regarding defendants' state of mind. 2 without prejudice. 3 4 Six, exclude evidence or argument relating to fraud on the FDA. 5 6 Granted That is granted. Seven, exclude evidence of unrelated manufacturing and regulatory matters. 7 MR. MILLING: 8 THE COURT: 9 MR. MILLING: That is granted. No opposition. Correct, no opposition. Just to clarify, Your Honor, 10 on the fraud on the FDA, you granted that, as I recall, 11 as to a claim on fraud of the FDA, not to the remaining 12 matters. 13 THE COURT: 14 Eight, exclude evidence of other lawsuits 15 or settlements. 16 Correct. Correct. That is granted. Nine, exclude evidence or argument 17 regarding unrelated products or documents or events or 18 labeling changes that postdate plaintiffs' alleged 19 February 2011 liver injury. 20 me make sure I'm completely consistent. 21 was granted. 22 Again, that motion -- let That motion Ten, exclude evidence or argument regarding 23 what FDA may do in the future. 24 Again, FDA really is going to be a big dog in these 25 proceedings. That motion's granted. You can't escape it. Golkow Technologies, Inc. Page 265 August 31, 2015 1 11, exclude evidence or argument related to 2 the September 2002 and June 2009 advisory committee. 3 That one is denied. 4 clear hearsay will not be admissible. 5 be the product of some of these discussions as a result 6 of exchanges between McNeil and the committee probably 7 are going to be pretty relevant. 8 9 But, again, what I find to be MR. MILLING: What I find to Just to be clear, Your Honor -- 10 THE COURT: You have given me the 11 impression -- they haven't denied it -- that a whole 12 lot of information flowed from McNeil to these people 13 on these committees. 14 one morning and read about a report. 15 MR. MILLING: So it wasn't like McNeil woke up Absolutely. I just want to 16 make the general comment that, as we all walked through 17 this case, in any pharmaceutical case any of the 18 lawyers have been in, all pharmacovigilance and 19 information the company hears about it is hearsay. 20 whether it's literature, adverse event -- 21 22 THE COURT: I'm talking about discussions within these committees and -- 23 MR. TISI: 24 THE COURT: 25 So product was. Recommendations. Yeah, I need to know what the I need to know that the product was Golkow Technologies, Inc. Page 266 August 31, 2015 1 something that came after what McNeil had a chance to 2 be heard on. 3 MR. HEWES: Your Honor, to answer your 4 question -- maybe this isn't your question -- but in 5 the past when the advisory committee meetings and 6 discussions were considered, Judge Higbee made an 7 exception for discussions between advisory committees 8 and testimony by the defendant who was at the advisory 9 committee meetings and correspondence related to that. 10 11 Everything else she excluded, but she did allow that. 12 Is that what you're allowing here? THE COURT: That's the kind of thing I'm 13 talking about. 14 morning and learned about this report and made 15 recommendations that were contrary to our position." 16 McNeil had input. 17 relevant. 18 McNeil can't say that "We woke up one So the exchanges are going to be MR. HEWES: Just so I'm boxed-up in my mind 19 with what we can talk about, what you're allowing with 20 the advisory committee and the AdComs and the working 21 group is -- consists of correspondence between the 22 advisory committee and McNeil and testimony by McNeil 23 at the advisory committees; is that correct? 24 25 THE COURT: Yeah, but there might also be final recommendations that McNeil was aware of that Golkow Technologies, Inc. Page 267 August 31, 2015 1 were promulgated, and they wouldn't be irrelevant 2 either. 3 MR. TISI: Right. So, for example, with 4 the working group document, Judge, the footnotes to it, 5 we consider McNeil's argument to X, and we rejected it 6 for Y. 7 So there's a lot of give-and-take, as you 8 said, and the recommendation comes after having 9 considered McNeil's arguments. 10 The advisory committee in 2002, the 11 publications that came out of that in 2009 discussing 12 all the evidence, came after McNeil's participation in 13 that. 14 there. 15 you. 16 That would be the Nourjah stuff. So it's all in I think we understand where you are. THE COURT: Thank 12, exclude evidence or 17 argument based upon defendants' constitutional rights. 18 That is granted, but that doesn't mean there won't be 19 any discussion at all. 20 21 MR. TISI: You wanted to see Dr. Kuffner's 30(b)(6) clips on that. 22 THE COURT: 23 MR. TISI: 24 THE COURT: 25 But generally it is granted. Correct. We'll send you that. 13, exclude evidence, argument related to foreign labeling or regulatory actions. Golkow Technologies, Inc. Page 268 August 31, 2015 1 And, again, that is denied for now. I do 2 want to look at the Canada -- I do want to look at the 3 Canada label and some of the case law that you cited. 4 5 6 Exclude marketing and promotional materials. That's denied. But, again, I need to see a proffer from 7 you as to just how expansive you want to make these 8 materials, because, again, I continue to be concerned 9 about what was your client influenced by. 10 MR. MILLING: Overall safety, number one, 11 recommended by doctors. 12 the theme of all the advertising. The general message, which is 13 THE COURT: 14 Exclude media reports relating to Tylenol. 15 16 Okay. I hear you. That's granted. Exclude evidence and argument relating to 17 statements admitted to the American Association for 18 Liver Disease. 19 neither granted nor denied. 20 what you want to submit by way of proofs one by one. 21 Again, that one is -- yeah, that one is I have to look at those, 17, exclude testimony regarding 22 inapplicable risk factors. 23 ruling, and I'm going to look more at risk factors over 24 the next few days. 25 weekend anyway, so I'll be home. Golkow Technologies, Inc. I made my preliminary I have no emergent duty this I'll have plenty of Page 269 August 31, 2015 1 time to read. 2 18, exclude evidence and argument regarding 3 negligence-based conduct of the manufacturer. 4 was granted. 5 6 MR. MILLING: 8 THE COURT: Why wouldn't I grant it? MR. MILLING: THE COURT: 12 MR. KOTT: Yeah. Okay. May I be heard? Motion in limine Number 13, foreign labeling. 14 THE COURT: 15 MR. KOTT: 16 I think it's not relevant anymore now that it's a design defect claim. 11 13 That motion was not -- This is the first time we're discussing it today. 9 10 Actually, I don't think that was made in the Taylor case. 7 That one Go ahead. And reports that you wanted, to refer to some of the cases that Mr. Milling -- 17 THE COURT: 18 MR. KOTT: Correct. Mr. Milling did not refer to -- 19 we have a number of cases. 20 to In Re Vioxx, which is a New Jersey decision affirmed 21 by the appellate division. 22 They've got cases outside of New Jersey 23 going both ways. 24 Re Vioxx. 25 Mr. Milling did not refer But it's cited in our brief. THE COURT: Golkow Technologies, Inc. It's In Thank you. Page 270 August 31, 2015 1 2 Anything else today? a lot of work to do. Mr. Kott, you've got So do I. 3 And we'll have the transcript fairly soon. 4 MR. KOTT: 5 The court prepared the order in Lyles on the motions in limine. 6 THE COURT: 7 MR. KOTT: I know. There was a lot like this where 8 you said granted, denied, granted without prejudice, 9 you'll have to show me X, Y, or Z. 10 In the order, however, the Court basically 11 just said granted without prejudice, denied without 12 prejudice, because if I get into all the -- what you've 13 said to counsel, "Yeah, but, Mr. Tisi, you have to show 14 me." 15 relitigate it. 16 We're never going to agree on it. We'll want to So I thought what I would say is, in the 17 opening paragraph, if the Court rendered oral 18 opinions -- later, if we have a discussion, what did 19 you mean when you said, "Granted," and you have to show 20 me, we can refer back to the transcript. 21 THE COURT: And I'm going to -- submit it 22 to me in a Word document form, not PDF. 23 them. 24 with it myself. 25 And show it to I don't have any doubt that I'll probably tinker MR. KOTT: Golkow Technologies, Inc. But I'm just inclined to do Page 271 August 31, 2015 1 denied, granted, denied without prejudice, whatever. 2 I'm just inclined to do the result. 3 THE COURT: If you can get that by the end 4 of the week or before, that would be very helpful, 5 because I'm going to be working on other things. 6 Anything else we need to address today? 7 MR. HORN: 8 9 Just a minute, please, Your Honor. MR. MILLING: Your Honor, a couple of 10 things that may be quick. 11 update the Court, as I understand it, we submitted 12 deposition designations actually in accordance with the 13 MDL schedule to the defense on July 1st, and then we 14 had designations in this case due sometime. 15 wrote a letter and said, "You already have our 16 designations." 17 Again, where we are, just to We just We just got the defense 18 counter-designations, I believe, yesterday. 19 candor, now we're trying Jackson on design defect, 20 given our conversations, I suspect both parties are 21 going to need to tweak their designations. 22 to make sure that the Court is comfortable with that. 23 In all And I want I'd also ask for leave for us to designate 24 one more witness, who is a scientist from Rutgers 25 University who helped developed the diallyl sulfone Golkow Technologies, Inc. Page 272 August 31, 2015 1 product. 2 THE COURT: 3 MR. MILLING: He's already been deposed? He's been deposed. We just 4 didn't designate it, given the grand scope of the case. 5 He wasn't going to be a focus. 6 defect designation, I'd like to add a designation for 7 him. 8 THE COURT: 9 MR. MILLING: Now that it's a design What's his name? 10 THE COURT: 11 MR. MILLING: His name is Chung Yang. I never heard of his name. He invented the diallyl 12 sulfone. 13 on the product. 14 granted on that product. 15 there where he talks about the practicability of the 16 product and feasibility of the product. 17 And he actually -- McNeil paid for the patent It was -- the U.S. patent was actually There was an affidavit in But I have not designated him, given the 18 overall scope of the warnings claim and the design 19 defect. 20 defect. 21 Obviously, we want to put him in on design I think, at the same time, though, there 22 will be some witnesses, if we go back -- if I can have 23 four or five days or through the weekend, I believe we 24 may be able to cut some witnesses. 25 just trying design defect, both sides may need to Golkow Technologies, Inc. Given that we're Page 273 August 31, 2015 1 tinker with designations, and we can come up with an 2 amicable schedule that's -- 3 THE COURT: I'm not opposed to that. How 4 does defense feel about them making modifications on 5 designations? 6 MR. HEWES: That's fine, Your Honor. The 7 question is, when are we going to sit down with you and 8 argue these? 9 down to. I mean, that's what it's going to come Time is short now. 10 THE COURT: It's getting short. 11 MR. HEWES: Last year we did it as the jury 12 questionnaire was going out. 13 Your Honor. 14 15 16 17 18 19 20 So whenever is best for Next week -THE COURT: Well, I think the ball is in their court to get the process started. MR. HEWES: It looks like it's the week that the jury gets selected. THE COURT: It looks like it will be. When are we going to have your new designations? MR. MILLING: We just got the -- I wasn't 21 even aware of it, given the speed that we've been back 22 and forth here, that we've got the defense 23 designations. 24 if we can strike some out. 25 work with Golkow. Obviously, I want to read each one, see And as soon as we can -- we We have a system. Golkow Technologies, Inc. We send it to -Page 274 August 31, 2015 1 who do we send it -- send it to Travis, his lawyer from 2 Butler Snow. 3 designations to him or say, "No change to this 4 witness." We've got a system down. Get the 5 But I think given the fact that it's just a 6 design defect, we may have testimony that we didn't put 7 in that we want to put in, and we may have testimony 8 about warnings that we don't need anymore. 9 as fast as I can. 10 11 THE COURT: Monday. How quick is that? I'll move Today is Wednesday? 12 MR. MILLING: 13 THE COURT: 14 MR. MILLING: Wednesday? Yeah, end of the day Wednesday. I can tell you that I have 15 two days of meetings and I have a -- how about Friday? 16 I'll start rolling them out as fast as I can. 17 THE COURT: 18 Thursday? 19 holiday. 20 Why not the end of the day Give them at least one workday before the MR. MILLING: I think they are going to be 21 shorter. 22 schedule, with my practice, I don't know that I can 23 turn the entire generic case around in two days. 24 a lot. 25 through to conform to the Court's ruling. Just being honest with you about my personal It's It's the entire case that needs to be read Golkow Technologies, Inc. It's a Page 275 August 31, 2015 1 pretty big task. 2 3 THE COURT: MR. MILLING: one day. I would be really only having I've got Tuesday and Wednesday booked. 6 7 You can't do the end of the day Thursday? 4 5 I'll beg for Friday. THE COURT: Get it done by the end of the day Friday. 8 MR. MILLING: 9 THE COURT: You're the best. Thank you. Anything else? 10 MR. MAYES: We're done. 11 MR. HORN: Yes, Your Honor, very briefly. 12 Mr. Kott made a statement and I wanted to respond. 13 did have an opportunity to speak to Ms. Jackson several 14 times over the weekend. She's looking forward to going 15 forward with the trial. We are going forward. 16 I She did ask me to convey to Your Honor that 17 she doesn't get paid when she doesn't work, so -- for 18 litigation. 19 it's okay if she's not here for the entire case and 20 come when she can. 21 Court of that. 22 So she wanted to ask me, Your Honor, if And I told her I would inform the But aside from that, she's looking forward 23 to testifying and we're looking forward to try the 24 case. 25 THE COURT: Golkow Technologies, Inc. It's okay with me if she has to Page 276 August 31, 2015 1 miss for work. 2 sort of statement that I would read to the jury 3 explaining her absence. 4 you would be able to agree upon that statement. 5 not, I'll come up with one. 6 7 MR. HORN: And I would hope the two of If So, just to continue, that is our response to Mr. Kott's statement. 8 9 What I would want to agree upon is some I would just like to issue the same statement. We're about to spend a lot of money on this 10 case. 11 client. 12 case, the same way they asked us, I'd ask they inform 13 us by Thursday of this week if any -- for any reason 14 they choose not to go forward. 15 us as well. 16 my client's money that they don't have. I'm sure defense is too. It comes out of our If defense has any interest in not trying the I ask that they contact Otherwise, I don't want to spend a lot of 17 THE COURT: 18 MR. HORN: They seem eager to go forward. I don't know. 19 if we're serious. 20 or whether they are or not. 21 But that's up to them. 22 choose, they let us know as soon as -- They keep asking 23 24 25 I don't really know what they are -- MR. MAYES: It's a design defect case. All I ask is whatever they We'll probably be here for the trial, Your Honor. THE COURT: Golkow Technologies, Inc. Okay. All right. Page 277 August 31, 2015 1 I'm trying to think -- I'm not sure the 2 next time we're going to meet. 3 hear from Mr. Kott between now and the end of the week. 4 And defense is going to hear from Mr. Milling. 5 going to work on my ruling regarding expert testimony. 6 I'm going to tinker with the document that Mr. Kott 7 gives me. 8 questionnaire soon. But I know I'm going to I'm And we're going to see the jury 9 And we'll see each other soon. MR. MILLING: Your Honor, I guess the last 10 thing. 11 defense, can they similarly turn it back around to me 12 in four days or so, so we can have the final product of 13 what we're arguing for Your Honor? If I'm going to turn this around to the 14 MR. KOTT: Completely unfair. Given it's 15 the Labor Day weekend, I don't want my friends in the 16 South to ruin their Labor Day weekend when we got into 17 this mess because of them. 18 them more time, but I don't think it's fair to say -- 19 MR. MILLING: 20 MR. KOTT: 21 MR. MILLING: I'm not objecting to giving What mess did I cause? By the late designations. No, no. I'm changing the 22 designations because we have a new ruling from the 23 Court. We're trying design defect. 24 25 MR. KOTT: designation. Right. They are adding a It just seems a little unreasonable when Golkow Technologies, Inc. Page 278 August 31, 2015 1 we're getting it on Friday on Labor Day weekend. 2 THE COURT: Well, four days from when? 3 Three days are holidays. 4 MR. MILLING: I'm just asking if we can get 5 it back in a reasonable time. 6 we just not have it -- 7 THE COURT: If somebody could -- if I heard you say four days. 8 I heard Mr. Kott jump up, and I said that three of 9 those four days are holidays. 10 MR. MILLING: Four business days. 11 going to do it in two. 12 I can't work on it Tuesday and Wednesday. 13 do it in two days. 14 15 18 I'm I represented to the Court that THE COURT: Four business days. I'm going to They'll probably have it done sooner. 16 17 And MR. HEWES: We'll do what it takes to get MR. HORN: Your Honor, can I have another it done. 19 housekeeping matter? 20 defense on the logistics. 21 jury selection process? 22 people have done it differently here. 23 if there are times there has been a situation where the 24 jurors fill out the questionnaire and they go home and 25 we all make our own copies, make three copies and we Golkow Technologies, Inc. We'll have to coordinate with Can we review with you the And by that I mean, I know In other words, Page 279 August 31, 2015 1 all go over them, and bring them back the next day -- 2 THE COURT: That's the plan we've had the 3 last year, and that's the plan I've done in every large 4 trial. 5 MR. HORN: Okay. So they'll come back the 6 next day, and we'll start seating people and asking 7 about questionnaires. 8 9 THE COURT: They're going to answer the questionnaires and go home. You are going to make 10 copies of the questionnaires. 11 the questionnaires amongst yourself and together. 12 There are going to be obvious people who shouldn't 13 serve for whatever reason. 14 questionnaires. 15 shouldn't serve, and we'll notify those not to come in. 16 I don't know how big that number will be. 17 it won't be a big number. 18 You're going to review I am going to look at the I may find obvious reasons people Hopefully, Then I'm going to get everybody together. 19 I hope we don't have to do this twice, depending on the 20 size of the courtroom. 21 together and I'm going to weed them out based on 22 hardship. 23 if they have a hardship. 24 them. 25 go. But I'm going to get everybody I will define what a hardship is. Ask them Discuss the hardship with Assuming the hardship is bona fide. Let them Get them out of the way. Golkow Technologies, Inc. Page 280 August 31, 2015 1 Then, depending upon your questions arising 2 from the individual questionnaires, we'll proceed then 3 with individual voir dire of the prospective jurors. 4 5 MR. HORN: one? 6 THE COURT: 7 MR. HORN: 8 THE COURT: 9 Call them up to the bench one by Correct. Okay. Any other thoughts? looking to make it as efficient as possible. I'm And my 10 goal will be to make this whole process as educational 11 for the jurors as possible so that they leave here, 12 regardless of what the verdict is, they leave here 13 feeling they learned something about the system and 14 feel better about the system. 15 16 MR. HORN: Do the casinos still have three days of jury duty and that's it, Judge? 17 THE COURT: I can envision it being a 18 hardship on a lot of workers out of the casino. 19 be guided by what they have to say. 20 that this could be five or six weeks. 21 less. 22 MR. MILLING: 23 THE COURT: 24 MR. HORN: 25 THE COURT: Golkow Technologies, Inc. We'll I'm anticipating I hope it's I don't think it'll be more. I hope it's less. I hope it's less. As efficient as you folks are, Page 281 August 31, 2015 1 I know it will be less. 2 MR. MILLING: 3 Your Honor, last thing, we talked about the I think it will be. 4 lawyers getting together to agree on admissibility of 5 documents. 6 expressed your expectation, we play the video, we put 7 the documents in. 8 premature until we have rulings on motions in limine. 9 We now have them -- 10 11 When we talked about it before, you've Mr. Hewes has indicated that it was THE COURT: Well, it's not premature anymore. 12 MR. MILLING: I'd like to have some 13 guidance from the Court on what the Court's 14 expectations are in terms of us agreeing on the 15 admissibility of documents. 16 THE COURT: 17 MR. KOTT: Go ahead, Mr. Kott. I think the logical way to do 18 this is have plaintiffs' counsel send to Mr. Hewes or 19 somebody on our side an exhibit list listing all the 20 exhibits. 21 the first draft they should tell us if there is a 22 question about authenticity in general so we have to 23 deal with custodian. 24 document, we'll go through it and we'll tell them which 25 ones -- we can't do anything in a vacuum without We'll then go through it. Golkow Technologies, Inc. And I think on So we can say Exhibit P-1 is this Page 282 August 31, 2015 1 getting their exhibit list. 2 THE COURT: Again, the ball is in your 3 court to start that process, because there may be a lot 4 of documents on there that turn out to be joint 5 exhibits. 6 their own. 7 And then they'll counter with a list of MR. MILLING: We started with -- we sent 8 the request to admit a number of weeks ago with all -- 9 with every document that was used that was currently in 10 the clips of the video. 11 Bates number for every document with a request to 12 admit, authenticity, and business rule exception. 13 admissibility. We sent the defense every And We're waiting on that response. 14 So we have started the process. 15 There may be other batches of documents 16 that I now want to work with defense counsel, and we 17 want to work with them to agree on in addition to 18 those, especially now the way the case is framed. 19 But 200 documents have been sent to the 20 defense weeks ago, waiting on a response from the 21 defense. 22 The ball is actually in their court. MR. HEWES: We're looking at that, Your 23 Honor. 24 Let's finish the last chapter. 25 for admissions and documents related to medical But we're talking about chapters and stories. Golkow Technologies, Inc. We also served requests Page 283 August 31, 2015 1 records. 2 So we are working through the issues. 3 burden the Court with this. 4 if we can work it out. 5 THE COURT: They objected to almost every one of them. We don't want to We'll take it up and see Well, I'm hopeful you'll be 6 able to work it out. 7 exhibits that you are in agreement on will be finalized 8 before we have opening statements. 9 exhibits people want to refer to. 10 And I'm hopeful that the list of Maybe certain And I would hope they would be in evidence 11 to save potential, you know, embarrassment or 12 explaining later. 13 evidence. 14 on as many things as possible. 15 16 If they aren't, they never get into I would hope that you would be able to agree MR. KOTT: I think we start, Your Honor, with an exhibit list and -- 17 THE COURT: I think you do too. He's 18 saying he's giving you a list of video clips -- you're 19 going to give them a list of documents? 20 MR. MILLING: I did. What I gave him was 21 the list of every -- the Bates number, just like it's 22 been done in other cases in this courthouse. 23 number. 24 the document was an internal document. 25 every document that was used with their corporate Bates Whether the document was an e-mail or whether Golkow Technologies, Inc. So far, it's Page 284 August 31, 2015 1 witnesses in depositions that we have decided that we 2 have right now identified as wanting to play. 3 I have sent 250 documents to them to ask 4 them if they will agree that they're admiss -- 5 authentic and admissible. 6 of the documents that are going to be used at the 7 trial. 8 THE COURT: 9 MR. MILLING: 10 That's probably 70 percent How long ago did you send them? How long did I send them? At least three weeks ago. 11 THE COURT: He's telling me that he gave 12 you 70 percent of the documents that he may need to 13 rely upon. 14 Can you respond to those 70 percent? MR. HEWES: I'd have to look. I don't know 15 exactly the extent that we responded to all of it, Your 16 Honor. 17 did go back and forth on some documents. 18 at them. 19 there's some ambiguity in terms of whether the document 20 becomes admissible would be decided upon if it's 21 authored in evidence, and I don't think we will agree 22 to those documents. 23 we can certainly come to -- 24 25 I would have to look at it and see. I know we We will look And to the extent that we can agree -- I know But there's certain documents that THE COURT: I would hope, particularly on the lady's medical records. Golkow Technologies, Inc. Page 285 August 31, 2015 1 MR. HEWES: Medical issues are one issue, 2 we thought that was a no-brainer. 3 record we identified, they objected to the contents of 4 the medical records. 5 6 THE COURT: But every medical They're the medical records for your client. 7 MR. MILLING: I will tell you that I know 8 myself, Mr. Tisi, I don't know about Mr. Horn, did not 9 participate in those responses. 10 them. 11 12 We'll take a look at THE COURT: Come on. How are not all her medical records relevant? 13 MR. HORN: We can work this out. I 14 actually only remember a -- I thought we worked out 15 almost all of those. 16 17 MR. HEWES: MR. HORN: MR. MAYES: MR. HORN: 23 records, I thought -- 25 No, we didn't talk about exhibits. 22 24 I thought Taylor and I worked on almost all of them. 20 21 We disagreed on them. 18 19 We didn't. MR. MAYES: Oh, exhibits, no. Medical We served her responses, and I thought that they were true and accurate copies of Golkow Technologies, Inc. Page 286 August 31, 2015 1 medical records. That's what the response is. 2 MR. HORN: We can work this out. 3 THE COURT: I don't understand. 4 Why aren't all her medical records admissible? 5 MR. MILLING: I guess it depends what all 6 of her medical records are. 7 requests are. 8 and throat visit in 2001, I don't -- it has nothing to 9 do with the case. 10 I don't know what the But if it has to do with an ear, nose, THE COURT: I have to agree with you. If 11 they try to use it, I'm going to ask them what's this 12 got to do with this case. 13 MR. HEWES: 14 medical records. 15 bridge to cross. 16 That's where we were on the We thought that was the easiest MR. MILLING: I think we're going to cross 17 the medical records issue easily. 18 got hundreds of corporate documents that we want the 19 defense to tell us whether or not they're admitted so 20 we can do exactly as Your Honor has said, play the 21 video. 22 THE COURT: The issue is we've Have the hundreds of documents, 23 the 70 percent of the evidence that you hope to rely 24 upon, have they been reduced to a list? 25 MR. MILLING: Golkow Technologies, Inc. Yes. The list is attached to Page 287 August 31, 2015 1 a request to admit, with every Bates number of every 2 document, which is how we've always done it, as well as 3 a description of the document. 4 request to admit. 5 THE COURT: Okay. And it was sent with a Without sending me the 6 documents, can you send me the list? 7 MR. MILLING: 8 9 10 11 Absolutely. It's just a list of Bates numbers, but sure. THE COURT: Next to the case number, doesn't it have -- doesn't it have a description? MR. MILLING: No. I'm happy to do that. 12 But the way I believe we were asked to do it by the 13 defense, and the way it's been done with Butler Snow in 14 other mass tort litigation, we send the Bates numbers, 15 and their system picks up the Bates number, the 16 beginning number and end Bates number of the document. 17 And just the description is very generic, e-mail. 18 THE COURT: 19 MR. MILLING: It's numeric; it's not generic. It's numeric. All the 20 documents and their system are all computerized. 21 They're able to quickly find the documents. 22 THE COURT: 23 MR. KOTT: I'm sure they are. At some point, the Court is 24 going to need an exhibit list. 25 this is they can send an exhibit list with P-1, P-2, Golkow Technologies, Inc. The easiest way to do Page 288 August 31, 2015 1 the Bates stamp, and a description of the document. 2 we were trying an automobile case and we were dealing 3 with our normal pretrial procedures here, you'd say, 4 look, pretrial, give me the exhibit list, because 5 that's the most reliable way we don't have a mess-up 6 where we don't know what we're talking about. 7 8 THE COURT: I guess Mr. Milling thought let's get it to them as quickly as possible. 9 MR. MILLING: 10 MR. MAYES: I started -- we have -They have several million 11 documents, Your Honor, for the Lyles case. 12 essentially every document that they'd exchanged in 13 discovery. 14 wanted to use. 15 really send us a legitimate list of exhibits, that's 16 fine. 17 approaches 2 to 3 million documents -- 18 It was We couldn't figure out which ones they So if they want to condense it and If it's going to be a Bates range that MR. MILLING: That's not what happened. 19 Last year, both sides had ridiculously long exhibit 20 lists. 21 list. 22 working so fast to get the Lyles case together. 23 If I talked to the gentleman who ran the exhibit I said it is our desire not to do that. We were What I had done is, I said, okay, what are 24 the core documents? 25 the documents that we used with all the corporate Golkow Technologies, Inc. Probably the core documents are Page 289 August 31, 2015 1 witnesses over and over again. 2 request to admit back in July to the defense to get 3 this done, so, at least as to the core documents, 4 there's no disagreement. 5 list with other documents that I find as fast as I can 6 that we might want to use. 7 I'm going to send a THE COURT: And then I'll send a separate But I've done -- Can you have somebody, your 8 staff between now and Friday when you're doing your 9 portion, have somebody else put names of documents next 10 11 to those numbers? MR. MILLING: I cannot. 12 can have that done. 13 We can probably do the best we can. I don't think I I'm only a four-person law firm. 14 MR. HORN: 15 THE COURT: We'll get that to you. I think if you give me an 16 exhibit list and say, memo, such a date, from so-and-so 17 to so-and-so, I'll start to get a feeling for what it 18 is that you're relying upon. 19 Bates stamps doesn't tell me anything. 20 21 MR. MILLING: Looking at a bunch of We'll figure out a way. And I think a lot of the documents, Your Honor -- 22 THE COURT: 23 MR. HORN: Seeger Weiss will get it done. We'll figure out a way. 24 you for volunteering us. 25 MR. MILLING: Golkow Technologies, Inc. Thank Of course, if the defendants Page 290 August 31, 2015 1 can respond in good faith, we request they do, because 2 that will take care of a lot of the issues. 3 THE COURT: It seems to me you gave them a 4 list of a bunch of Bates stamp numbers, which your 5 computer should be able to recognize and respond. 6 the meantime, somebody is going to get me a list that 7 is going to have names of documents so I get a feel for 8 how many memos are internal to McNeil and how many -- 9 you know, on and on and on. 10 MR. MILLING: 11 MR. KOTT: In You tell me. We'll do it. One other thing I don't want to 12 raise now, happily. 13 temperature on the Court's inclination to have time 14 limits on presentation of cases. But I wanted to take the Court's 15 And we're not ready to talk about that. 16 you say, Mr. Kott, we never do that, we won't waste 17 your time. 18 THE COURT: If I have done it when lawyers are 19 in agreement to doing it. 20 anybody how to try the case or how long it takes to put 21 their case in. 22 23 24 25 I'm not going to tell If you could agree to time limits, I think that could be very helpful to everybody. Here is what I do not want to do. I do not want to give the jurors an end date and then I'm Golkow Technologies, Inc. Page 291 August 31, 2015 1 pleading with them to stick around another week, 2 because that gets pretty hairy. 3 MR. TISI: I mean, it depends on how much 4 we stuff the turkey. 5 we're going to try to get video testimony, that's 6 pretty streamlined. 7 and hours of extra stuff, that will extend the time. 8 I'm sure counsel will do their best, and we'll figure 9 it out. 10 I mean that respectfully. If we end up with hours and hours THE COURT: With regards to hours and hours 11 and hours of videos, let me say this to you. 12 the best movies ever made is 84 minutes long. 13 called the Ox-Bow Incident. 14 mortality tale. 15 seen, and it's 84 minutes long. 16 If One of It's It's the ultimate And it's the top ten movies I've ever When you present a video to a jury that I 17 think is longer than 90 minutes, believe me, they're 18 checking it out. 19 You don't have them anymore. MR. TISI: That's sometimes, frankly, why 20 so much is counter-designated so that jury will check 21 out. 22 THE COURT: That's my big fear. 23 fear is that -- what's the expression? 24 over. 25 MR. MILLING: Golkow Technologies, Inc. My big My eyes glaze I don't think any designation Page 292 August 31, 2015 1 we sent is over 90 minutes. 2 added in to make the video longer, but our 3 presentation -- 4 THE COURT: I don't know what they Well, we certainly will take 5 breaks at the appropriate time. 6 about the length of videos sometimes get lost on their 7 audience. 8 MR. TISI: 9 THE COURT: 10 11 I just warn lawyers Thank you, Your Honor. Okay, guys. Have a good week. Have a good holiday. (Concluded at 4:15 p.m.) 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Golkow Technologies, Inc. Page 293 August 31, 2015 1 C E R T I F I C A T E 2 3 I, MICHELLE L. GRAY, CSR, CCR, RPR, License 4 Number 30XI00212600, a Certified Court Reporter in and 5 for the State of New Jersey, do hereby certify the 6 foregoing to be prepared in full compliance with the 7 Current Transcript Format for Judicial Proceedings and 8 is a true and accurate compressed transcript to the 9 best of my knowledge and ability. 10 11 12 13 14 _________________________________ 15 MICHELLE L. GRAY, CCR, CSR, RPR NJ Certified Court Reporter 16 17 18 19 20 21 22 23 24 25 Golkow Technologies, Inc. Page 294