1 1 IN THE UNITED STATES DISTRICT COURT 2 DISTRICT OF WYOMING 3 -------------------------------------------------------- THE ESTATES OF DEBORAH MARIE TOBIN, 4 and ALYSSA ANN TOBIN, deceased, by TIMOTHY JOHN TOBIN, personal 5 representative; and THE ESTATES OF DONALD JACK SCHELL, and 6 RITA CHARLOTTE SCHELL, deceased, by NEVA KAY HARDY, personal representative, 7 Plaintiffs, 8 Case No. 00-CV-0025-BEA vs. June 5, 2001 9 Excerpt of Volume XI SMITHKLINE BEECHAM PARMACEUTICALS, 10 Defendant. 11 ----------------------------------------------------------- 12 EXCERPTED TRANSCRIPT OF TRIAL PROCEEDINGS 13 CLOSING ARGUMENTS 14 15 Excerpted Transcript of Trial Proceedings in the 16 above-entitled matter before the Honorable William C. Beaman, 17 Magistrate, and a jury of eight, at Cheyenne, Wyoming, 18 commencing on the 21st day of May, 2001. 19 20 21 Court Reporter: Ms. Janet Dew-Harris, RPR, FCRR Official Court Reporter 22 2120 Capitol Avenue Room 2228 23 Cheyenne, Wyoming 82001 (307) 635-3884 24 25 2 1 A P P E A R A N C E S 2 For the Plaintiffs: MR. JAMES E. FITZGERALD Attorney at Law 3 THE FITZGERALD LAW FIRM 2108 Warren Avenue 4 Cheyenne, Wyoming 82001 5 MR. ANDY VICKERY Attorney at Law 6 VICKERY & WALDNER, LLP 2929 Allen Parkway 7 Suite 2410 Houston, Texas 77019 8 For the Defendant: MR. THOMAS G. GORMAN 9 MS. MISHA E. WESTBY Attorneys at Law 10 HIRST & APPLEGATE, P.C. 1720 Carey Avenue 11 Suite 200 Cheyenne, Wyoming 82001 12 MR. CHARLES F. PREUSS 13 MR. VERN ZVOLEFF Attorneys at Law 14 PREUSS SHANAGHER ZVOLEFF & ZIMMER 225 Bush Street 15 15th Floor San Francisco, California 94104 16 MS. TAMAR P. HALPERN, Ph.D. 17 Attorney at Law PHILLIPS LYTLE HITCHCOCK 18 BLAINE & HUBER, LLP 3400 HSBC Center 19 Buffalo, New York 14203 20 INDEX CLOSING ARGUMENTS PAGE 21 By Mr. Vickery 3 By Mr. Pruess 10 22 By Mr. Fitzgerald 79 23 24 25 3 10:54:11 1 P R O C E E D I N G S 10:54:11 2 (Jury instruction conference proceedings in 10:54:11 3 chambers 8:30 a.m. until 10:50 a.m. not transcribed.) 10:54:11 4 (Following in the presence of the jury 10:54:11 5 11:00 a.m., June 5, 2001.) 11:03:42 6 THE COURT: Good morning, ladies and gentlemen of the 11:03:44 7 jury. I want to apologize first for the one-hour delay. As 11:03:47 8 I promised you, we would start at 10:00, I haven't missed 11:03:54 9 that time too many times during the trial but we desperately 11:03:59 10 needed that hour and we appreciate your patience. 11:04:02 11 As I told you, we will go forward with the closing 11:04:04 12 arguments of counsel. Counsel have agreed to one hour and 30 11:04:08 13 minutes for each side. The plaintiff gets the opportunity to 11:04:11 14 reserve a portion of that time, as I said yesterday, for 11:04:15 15 rebuttal. 11:04:20 16 Mr. Vickery, are you ready to proceed? 11:04:22 17 MR. VICKERY: I am, thank you, Judge Beaman. 11:04:24 18 THE COURT: And I'm timing them, by the way, so you 11:04:27 19 know we will be pretty close. 11:04:29 20 MR. VICKERY: May it please the Court, good morning, 11:04:32 21 ladies and gentlemen. 11:04:33 22 This is the second time I can talk to you directly. 11:04:42 23 This is my final statement, my opportunity to address you, 11:04:44 24 the second time I could address you directly in the context 11:04:47 25 of this case, and I intend to use the time that's been 4 11:04:50 1 allotted to emphasize portions of the evidence to you, the 11:04:55 2 portions that I think support my client's case. 11:05:00 3 I come to you from Texas seeking justice for the 11:05:07 4 wrongful deaths of four of your own; not three of your own, 11:05:12 5 four of your own. This is a wrongful death case. It is 11:05:20 6 about the wrongful and unnecessary and tragic deaths of four 11:05:25 7 innocent people. 11:05:26 8 And in the time the Court has allotted me this 11:05:29 9 morning, I've got some notes and I've got some things I'm 11:05:32 10 going to show you. I have some Power Point slides that I'm 11:05:37 11 going to put up. 11:05:38 12 But mostly, mostly I'm going to talk to you from 28 11:05:41 13 years of experience in representing the small vulnerable 11:05:48 14 people in society, from the record in this case and from my 11:05:52 15 heart. 11:05:53 16 I want to talk to you about two things. Power and 11:06:01 17 responsibility, and then, of necessity, money and magic. 11:06:11 18 Power and responsibility: Well, whose power and what 11:06:15 19 responsibility? 11:06:15 20 This is sacred space. People are empowered in this 11:06:20 21 space, little people are empowered in this space. In the 11:06:24 22 halls of industry, little people like Tim Tobin and Neva 11:06:29 23 Hardy, little people, really little people like Alyssa Tobin 11:06:36 24 have no power. They have no power. 11:06:39 25 Their experiences, you see, can be lost in a mishmash 5 11:06:44 1 of statistical significance. Their experiences can be 11:06:48 2 written down to zero in the interests of mathematical 11:06:52 3 cleanliness. They have no power there. In the outside world 11:07:00 4 I have no power. Mr. Fitzgerald has no power. In the 11:07:04 5 outside world you have no power other than what affects your 11:07:07 6 daily lives. 11:07:09 7 Think about it. Three weeks ago you were summoned to 11:07:12 8 a place where you probably didn't want to come, told where to 11:07:15 9 sit, where to stand, what to do, to do a job you probably 11:07:21 10 didn't want to do. 11:07:23 11 Look what has happened in the course of three weeks. 11:07:28 12 When you come in, we stand. When you get ready to leave, we 11:07:31 13 stand until you're out. Because you have been empowered by 11:07:39 14 the citizens of Wyoming and by this federal court to be 11:07:42 15 judges of the facts and dispensers of justice in this case, 11:07:49 16 you have the power to render justice that no one else has and 11:07:53 17 it is a very sacred and important power. 11:07:58 18 When I talk about -- look at this, I'm showing you a 11:08:04 19 slide that didn't even show up -- power and responsibility -- 11:08:15 20 when I talk to you over the next hour of power, what I'm 11:08:17 21 talking about is the power of your verdict. 11:08:21 22 Now, that is one statistic that cannot be written 11:08:28 23 down to zero. That's one statistic that cannot be ignored. 11:08:32 24 That's one statistic that cannot be explained away. That is 11:08:35 25 a statistic that can render justice in this case and make a 6 11:08:39 1 difference in the world to come. 11:08:43 2 Power to do what, you say? Just this: To decide who 11:08:48 3 is responsible for these senseless deaths. Who is 11:08:53 4 responsible? There's a concept at law called fault and it 11:08:57 5 includes both negligence and it includes a body of law called 11:09:00 6 products liability. Once all the lawyers have finished 11:09:04 7 talking to you, His Honor Judge Beaman will give you 11:09:08 8 instructions on the law and he'll tell you about that. 11:09:14 9 And he's the source of the law. You see, he has the 11:09:14 10 power to tell all of us what the law is in this case. You 11:09:18 11 have the power to decide the disputed issues of fact. He's 11:09:23 12 the judge of the law. You are the judges of the facts. 11:09:27 13 Now, we have contended in this case that SmithKline 11:09:32 14 Beecham has fault under the law in two respects. They failed 11:09:38 15 to warn. They failed to give the warning that they should 11:09:42 16 have given years ago about these drugs. 11:09:48 17 And they failed to conduct any kind of prospective 11:09:53 18 tests to discern not only do these drugs really cause these 11:09:57 19 dangers for a small, vulnerable subpopulation of people, and 11:10:01 20 if so, how many and, more importantly, what can be done to 11:10:06 21 avoid those problems? 11:10:10 22 You remember in the opening statement I told you you 11:10:12 23 were going to learn a lot in these three weeks about SSRI 11:10:17 24 drugs, and now you know what they all are -- Prozac, Zoloft, 11:10:23 25 Paxil. You probably even remember that Celexa and Luvox are 7 11:10:28 1 SSRI drugs. 11:10:30 2 And I told you that we would prove since 1990 11:10:34 3 SmithKline Beecham knew that there was a small, vulnerable 11:10:37 4 subpopulation of patients who were at risk and that Don 11:10:42 5 Schell was one of those people. 11:10:44 6 Now, have we proved our case or not? There are a few 11:10:49 7 of you on the jury who are probably old enough to remember 11:10:52 8 Watergate and a famous congresswoman from my home state, 11:11:01 9 Barbara Jordan, who will always be remembered when one of the 11:11:05 10 people came to testify before that committee and she said, 11:11:08 11 "Tell us, sir, what did you know and when did you know it?" 11:11:13 12 Well, what did SmithKline Beecham know about the risk 11:11:17 13 for a small, vulnerable subpopulation, when did they know it 11:11:22 14 and what have they done about it? 11:11:24 15 I must invite you to come with me again back to 11:11:28 16 Philadelphia, Pennsylvania in 1989. At that point in time 11:11:34 17 they completed the new drug application. It chronicled the 11:11:41 18 experience of 2,963 patients, real, live human beings on 11:11:46 19 Paxil. And you have seen excerpts throughout the trial of 11:11:52 20 some of the tables that were presented there. 11:12:02 21 Let's look at one or two together for a minute: This 11:12:12 22 was what was filed in 1989, November of 1989, by Beecham 11:12:19 23 Laboratories, which was the laboratory division of SmithKline 11:12:23 24 Beecham. 11:12:24 25 Check this one out, "Better products through 8 11:12:26 1 international research." And you have seen many documents 11:12:37 2 like this one, and you will have them all to go through. You 11:12:43 3 see that people employed by them -- now, I suspect they may 11:12:49 4 say, "Oh, these were clinical investigators. These weren't 11:12:54 5 salaried employees. These were people we hired to conduct 11:12:57 6 our tests." 11:12:59 7 So what? People employed and paid by SmithKline 11:13:02 8 Beecham made a determination of the relationship of these 11:13:04 9 various adverse events to their drug. And when they said 11:13:08 10 definitely related, they wrote 5, probably was 4, and 11:13:13 11 possibly was 3. 11:13:16 12 I urge you -- these are Exhibits 10 through 16, 11:13:22 13 Plaintiff's Exhibit 10 through 16, and I urge you to start 11:13:24 14 your deliberations by looking through some of those. These 11:13:27 15 are tedious and if I hadn't highlighted them for you, it 11:13:31 16 would take you forever to find some of them. 11:13:40 17 So what we've done is this. We have prepared some 11:13:51 18 summaries, some excerpts and summaries from these voluminous 11:13:57 19 records and they're summaries of adverse events of the type 11:14:01 20 that Dr. Healy and Dr. Maltsberger explained to you are the 11:14:06 21 harbingers or precursors of violence and suicide. The 11:14:10 22 excerpts we've prepared are the ones that said "definitely 11:14:13 23 related to our drug" or "probably related to our drug," or in 11:14:16 24 some cases in the first two weeks, "possibly related to our 11:14:20 25 drug." 9 11:14:23 1 Now look at them: Nightmares, 43 days, definitely 11:14:27 2 related; restlessness, 1 day, possibly related; nocturnal 11:14:33 3 restlessness, 3 days, definitely; extremely agitated, two 11:14:38 4 days, just like Don Schell. 11:14:40 5 "This is not a case about whether two pills caused a 11:14:44 6 man to do something." Did we hear that in the opening 11:14:46 7 statement? Two pills, possibly. Four pills, restlessness, 11:14:53 8 definitely. 11:15:05 9 49-year-old female, anxiety on the second day, like 11:15:08 10 Don Schell, definitely related. 11:15:11 11 60-year-old male, like Don Schell, great anxiety on 11:15:14 12 day one, possibly related. 11:15:26 13 Check this one out. Akathisia -- remember they said 11:15:30 14 akathisia is just caused by neuroleptic drugs? No proof that 11:15:36 15 SSRI drugs cause akathisia. Akathisia, day 2, possibly; day 11:15:39 16 1, possibly; day 9, definitely related to the drug; day 4, 11:15:43 17 definitely related to the drug; day 5, definitely related to 11:16:03 18 the drug; depersonalization, day one, possibly related in two 11:16:08 19 instances; hallucinations, day one, definitely caused by the 11:16:14 20 drug. 11:16:15 21 You get the point. I could go on and on. That was 11:16:29 22 the experience of those 2,963 people. In Philadelphia in the 11:16:39 23 time period from 1988 to 1993 is when they finalized this new 11:16:45 24 drug application. Remember the testimony of Christine 11:16:49 25 Blumhardt, 21 percent of the people in the clinical trials 10 11:16:52 1 dropped out because of the side effects. And here are all of 11:16:55 2 the ones that -- here are all the ones that were documented 11:17:12 3 to be definitely or probably related or possibly related 11:17:16 4 within the first week or two, all of these side effects. 11:17:19 5 Now what did they do about that? This is 11:17:29 6 interesting. In November 1989, three months before the 11:17:32 7 Teicher and Cole article hit, before it became a public 11:17:36 8 concern that Prozac, the first of the SSRI drugs, was 11:17:39 9 precipitating suicide in some people, they didn't have any 11:17:43 10 problem making these determinations were they causally 11:17:46 11 related. They filed away the little reports. 11:17:48 12 It was only after it became a matter of public 11:17:51 13 concern, after there were the threats of proceedings such as 11:17:55 14 this that Dr. Ian Hudson said it is impossible to decide in 11:18:02 15 an individual case if the drug causes or does not cause these 11:18:06 16 events. In an individual case it is just impossible, 11:18:10 17 unless -- finger in the page -- you happen to be a defense 11:18:14 18 expert hired by these people to try to beat this family and 11:18:17 19 this court. Then all of a sudden it is possible. 11:18:31 20 Well, you have all the info on these patients. What 11:18:35 21 else did they know about the small, vulnerable subpopulation? 11:18:40 22 You know, I talked to Dr. Mann. He's an individual who has 11:18:43 23 devoted his life to the study of suicide, and I think it is 11:18:49 24 unfortunate that for three years he wrote on behalf of the 11:18:53 25 small, vulnerable subpopulation of people and for whatever 11 11:18:58 1 reason abandoned them in favor of the majority. 11:19:01 2 What did he write? In 1991 he wrote, "Whether 11:19:05 3 certain antidepressants precipitate or aggravate suicidal 11:19:10 4 ideation in a small, vulnerable subpopulation of psychiatric 11:19:13 5 patients who require antidepressants is uncertain, but," he 11:19:17 6 went on, "paradoxical suicidal ideation or behavior may be 11:19:22 7 more frequent in patients with unrecognized akathisia." 11:19:25 8 Do you remember Dr. Suhany when he treated him on 11:19:28 9 Prozac said, "I didn't recognize that as akathisia." 11:19:31 10 Dr. Maltsberger and Dr. Healy said those are the classic 11:19:36 11 symptoms of akathisia that he had, but it was unrecognized. 11:19:40 12 In 1992 the same man, their expert, said, "Side 11:19:44 13 effects such as akathisia may be associated with a worsening 11:19:50 14 psychiatric state. Patients should be warned." 11:19:54 15 Remember the last expert, Dr. Merrell, talking about 11:19:57 16 empowering the family? How do you do that if you don't alert 11:20:00 17 them. "Applying this standard" -- a typo boo-boo -- 11:20:04 18 "clinical practice to all patients would constitute a 11:20:06 19 reasonable safeguard in the event that there are indeed a 11:20:11 20 small minority of vulnerable patients who are at risk for 11:20:15 21 emergent suicidal ideation." He went on to say that could be 11:20:19 22 caused by other things, but in a few cases because of an 11:20:22 23 adverse effect of the antidepressant. 11:20:25 24 The following year he wrote a letter to the editor 11:20:28 25 when somebody tried to whitewash the issue and say there was 12 11:20:31 1 no problem with Prozac, and he said, "This study highlights 11:20:34 2 the need for better controlled research, prospective studies, 11:20:38 3 to determine whether specific antidepressant drugs are 11:20:41 4 associated with emergent suicidality in a subpopulation of 11:20:45 5 depressed patients." 11:20:48 6 What other sources of knowledge did they have? 11:20:50 7 Remember, I told you in the opening statement about 11:20:54 8 Dr. Wheadon? He worked at Eli Lilly for several years. When 11:20:58 9 the Teicher and Cole article came out, he flew to Boston, 11:21:04 10 went to Europe and met with seven different international 11:21:07 11 experts who said, "The only way to study this, the best way, 11:21:10 12 the most definitive way is with a prospective study." 11:21:14 13 And yesterday afternoon you heard in rebuttal his 11:21:16 14 testimony read by my colleague, Mr. Fitzgerald, that said, 11:21:22 15 "We've never done that. We've never done a prospective 11:21:23 16 study," the very thing he was told was the best way to study 11:21:26 17 it. 11:21:30 18 And he helped Dr. Charles Beasley design a study, a 11:21:35 19 study to use the exact methodology that Dr. Healy has 11:21:40 20 indicated should be used, a rechallenge study. Remember, 11:21:44 21 Dr. Mann called it an A-B-A design. 11:21:52 22 That's not the only source of their knowledge. 11:21:55 23 There's scientific knowledge in many articles. We could be 11:22:00 24 here for months if we went through each and every one of 11:22:02 25 them, but the Lane article in 1997 sort of summarized them 13 11:22:06 1 all. Do you remember that -- 11:22:08 2 MR. PREUSS: Your Honor, I will object to any 11:22:09 3 reference to the Lane article. There is no testimony from 11:22:12 4 any witness on the substance of that article. 11:22:14 5 MR. VICKERY: Your Honor, I think that both Dr. Healy 11:22:16 6 and Dr. Maltsberger testified about the Lane article and I 11:22:22 7 cross-examined one or two of their witnesses about it. 11:22:26 8 THE COURT: Overruled. 11:22:28 9 MR. VICKERY: Remember, this man works for an SSRI 11:22:30 10 manufacturer, Phizer. Lane wrote that don't just blame 11:22:34 11 neuroleptic drugs, SSRI drugs cause akathisia and akathisia 11:22:37 12 increases the risk of violence or suicide. 11:22:44 13 Now, warnings: Failure to warn, failure to test, 11:22:48 14 that's what we're going to talk about. Warnings, ladies and 11:22:57 15 gentlemen, are a matter of clinical judgment and clinical 11:23:08 16 needs. I know how boring it is to watch video depositions 11:23:11 17 and I'm sorry for that. I wish I could have forced every one 11:23:14 18 of those people to come here live. I would have loved to 11:23:19 19 have the opportunity to question them here live. 11:23:21 20 You see, what little power I have in the world to 11:23:23 21 remedy injustice is in this room. It is in this room. It is 11:23:28 22 in my power to insist, and I hope I haven't offended anybody 11:23:33 23 by trying to insist on getting a straight answer to a 11:23:36 24 straight question. It is the power to make them give us 11:23:39 25 documents like these documents that were filed in 1989 that 14 11:23:42 1 Dr. Mann and his colleagues never got. It is the power to 11:23:46 2 make them at least in their home town of Philadelphia give 11:23:50 3 their depositions. 11:23:55 4 Well, here was very, very important testimony about 11:23:59 5 warnings. 11:24:01 6 "I'm a clinician. For me it is a clinical decision. 11:24:05 7 It is a matter of what is clinically important, what is 11:24:08 8 clinically valid, what is clinically relevant to the use and 11:24:11 9 abuse of a medication. That's what it comes down to. And, 11:24:15 10 you know, it is not regulatory at all. If I felt or the 11:24:18 11 people around me felt that there was a significant problem, 11:24:21 12 whether or not the agency felt -- the agency meaning the 11:24:24 13 FDA -- felt it was a problem that we needed to have a warning 11:24:27 14 on, I personally would feel that -- feel compelled to put it 11:24:30 15 on our label." 11:24:32 16 Now, who said that? Who said that? The man that 11:24:35 17 said it was a director of SmithKline Beecham. He's above the 11:24:40 18 level of vice-president. He's the head of research. 11:24:43 19 Dr. Taki Yamada said that in his deposition. "It is a matter 11:24:50 20 of clinical judgment." 11:24:52 21 Now, whose clinical judgment? I ask you to focus on 11:24:55 22 two parts of the evidence regarding clinical judgment. 11:24:57 23 First, the testimony of this man sitting right out here, 11:25:00 24 Dr. Maltsberger, who has devoted 41 years of his life to 11:25:05 25 studying suicide and trying to prevent it and doing a darned 15 11:25:09 1 fine job, I might say, in his own practice. Even Dr. Mann 11:25:13 2 had to concede that this man has vast clinical experience. 11:25:18 3 Let's look at his judgment and testimony and then 11:25:21 4 let's look at the one that mattered the most, let's look at 11:25:27 5 clinical judgment and the clinical needs of Dr. Kirkikumar 11:25:36 6 Patel who prescribed Paxil. 11:25:38 7 What did Dr. Maltsberger say on the stand? He said 11:25:42 8 that SmithKline Beecham should warn that for some patients, 11:25:45 9 some patients, drugs like Paxil cause akathisia. 11:25:49 10 Well, now that's a tenpenny word, so I said "What do 11:25:53 11 you mean? Put it in terms that we can understand." Turmoil, 11:25:58 12 it causes turmoil. He says that it causes mania and 11:26:02 13 hypomania. "What do you mean by that, Doc?" "Well, what I 11:26:07 14 mean is frenzy." 11:26:08 15 You remember I asked him, "Are turmoil and frenzy the 11:26:11 16 kinds of things that precipitate violence and suicide?" He 11:26:15 17 said that's exactly the condition that people get in that 11:26:18 18 triggers people who may or may not be at risk because of some 11:26:21 19 depressive symptom. That's exactly what triggers their 11:26:28 20 behavior. 11:26:30 21 And he also said they should warn about psychosis. 11:26:33 22 And we've seen in these Exhibits 10 to 16 instances where the 11:26:37 23 drug causes psychosis, which he explains simply are 11:26:42 24 hallucinations or delusions. 11:26:44 25 Don Schell had hallucinations on Prozac. His 16 11:26:49 1 sister-in-law overheard him telling her sister and her niece, 11:26:57 2 Deb Tobin, "I was seeing things that weren't there. I was 11:27:01 3 scared to death. Girls, don't ever let that happen to me 11:27:04 4 again." 11:27:05 5 Well, unfortunately he doesn't have a degree in 11:27:08 6 psychopharmacology. He didn't know that Paxil was a drug in 11:27:11 7 the same class and his doctor wasn't warned about this risk 11:27:16 8 for that class of drugs. 11:27:20 9 Dr. Maltsberger drafted a warning. Why? Because the 11:27:25 10 defense lawyers asked him to. They said, "Put your money 11:27:28 11 where your mouth is. You think we should have a warning. 11:27:32 12 What should it look like?" 11:27:33 13 It wasn't real hard. He didn't have to be a warnings 11:27:36 14 expert or FDA expert to draft something that would have 11:27:39 15 alerted Dr. Patel, and he did testify, to get somebody's 11:27:45 16 attention put it in a black box. 11:27:50 17 Now, how about Dr. Patel? What did he say? Well, he 11:27:55 18 said that if the written material -- he doesn't like those 11:27:59 19 salesmen very much. You kind of get that feeling. Doesn't 11:28:02 20 pay much attention to them. 11:28:04 21 But he does pay attention to the label. He knows 11:28:06 22 that the label says you don't give a SSRI within 14 days of a 11:28:12 23 MAOI. Why? Because Prozac had a problem with a MAOI. Not 11:28:18 24 Paxil, Prozac. It is right there in the label, 11:28:23 25 Exhibit 200-B, because of a problem with a different SSRI 17 11:28:26 1 we're going to warn you not to give this drug within 14 days 11:28:30 2 of a MAOI. 11:28:33 3 So he said, "Boy, if they had told me in writing what 11:28:36 4 the salesman said here, that for an anxious person like Don 11:28:40 5 Schell I would only give a half dose to start." Why? 11:28:46 6 Dr. Healy explained it. Because of the SSRI drugs this is 11:28:49 7 the most potent inhibitor of serotonin reuptake. It is the 11:28:53 8 most powerful drug. It is the one most likely to cause a 11:28:57 9 problem in the first day or two or three. That's why he 11:29:00 10 would have cut the pill in half. 11:29:02 11 He said, "Boy, if I had known what they tell those 11:29:06 12 German guys about giving a concomitant sedative, other 11:29:10 13 medication to take the edge off, then I would have done what 11:29:14 14 Dr. Suhany did when he gave him Prozac." He gave him a 11:29:19 15 benzodiazepine, Ativan, and when he began to have the 11:29:23 16 symptoms of "obvious somatic anxiety today," he upped the 11:29:27 17 dosage to try to deal with it. 11:29:29 18 It didn't work. Three weeks later his hands were 11:29:32 19 trembling and he tried another antidote, a beta blocker. And 11:29:38 20 that didn't work, so he took him off of it and worked fine on 11:29:43 21 imipramine. 11:29:44 22 Dr. Patel said that he certainly would have taken a 11:29:47 23 more thorough history when Don told him -- and it is right 11:29:50 24 there in the records. You have it -- "Prozac didn't help 11:29:53 25 me." 18 11:29:53 1 Well, I guess they'll say it was Don Schell's fault. 11:29:56 2 He should have come in and said, "I had Prozac once, Doc, and 11:30:01 3 that's an SSRI drug, and I had hallucinations on that drug." 11:30:04 4 Come on, this is an ordinary man. He went to his doctor and 11:30:08 5 said, "I tried Prozac. It didn't help." 11:30:11 6 Now, properly alerted the doctor would have said, 11:30:14 7 "Let's dig into that a little bit deeper. What do you mean, 11:30:18 8 didn't help? Did you get a tummy ache, headache?" "No, Doc, 11:30:23 9 I saw things. I saw things that weren't there." 11:30:27 10 "Uh-oh, I got a warning that this class of drugs can 11:30:32 11 precipitate psychosis. I have a patient that tried one of 11:30:36 12 this class of drugs. He's seeing things that aren't there." 11:30:39 13 "What worked for you, Don?" 11:30:41 14 "Well, imipramine worked for me real fine, Doc." 11:30:44 15 "Let's try that." 11:30:45 16 He would have alerted the family. That's what 11:30:48 17 Dr. Patel said. He would have empowered the family. The 11:30:54 18 thorough history you see would have revealed that there were 11:30:57 19 akathisia-like symptoms on Prozac, in spite of the antidote; 11:31:04 20 that Prozac absolutely scared him to death and made him see 11:31:07 21 things that weren't there; that imipramine really worked for 11:31:12 22 him. In sum, the warning would have precipitated a history 11:31:20 23 which would have revealed that Don Schell was one of the 11:31:22 24 small, vulnerable subpopulation of people. 11:31:36 25 Now, we have said that they ought to use a warning. 19 11:31:39 1 It ought to be in bold type. It ought to be in the warnings 11:31:42 2 section, and indeed, that it should be inside of a black box. 11:31:46 3 Why not put it inside of a black box? Well, there's 11:31:50 4 the truth and then there's their arguments. Let's look at 11:31:54 5 them. 11:31:59 6 When you take a warning and you surround it with a 11:32:00 7 little black box, you can't use those mugs and pens and golf 11:32:05 8 balls that Dr. Mann was talking about to remind physicians to 11:32:09 9 prescribe Paxil; no TV ads so that 84 percent of the people 11:32:16 10 who ask a doctor for a prescription by name will get it. 11:32:22 11 You see, two of the top executives of SmithKline 11:32:25 12 Beecham acknowledged that a black box warning would hurt 11:32:31 13 sales. Dr. Taki Yamada said, "I believe a black box warning 11:32:37 14 would have an impact on the sales of Paxil." And with great 11:32:41 15 understatement the vice-president of marketing, Bonnie 11:32:45 16 Rossello, said a warning about suicide probably wouldn't help 11:32:48 17 sales. 11:32:54 18 Now, what are their arguments? They say, "There's no 11:32:57 19 scientific proof of causation. Why should we warn until 11:33:00 20 there's been scientific proof that this absolutely, 11:33:04 21 positively, without question, beyond a reasonable doubt does 11:33:06 22 cause it in X, Y, Z percent to a statistically significant 11:33:12 23 degree," blah, blah, blah, blah. 11:33:17 24 And they say, besides that, it would discourage 11:33:20 25 people from taking Paxil. And that's where they really want 20 11:33:24 1 to scare you. They want to scare you, say, "Oh, if you 11:33:31 2 render a verdict that leads to warnings, think of the people 11:33:34 3 who will be at risk." 11:33:38 4 Let's look at those. With regard to the first, 11:33:41 5 that's answered by the FDA regulations. You heard testimony 11:33:45 6 from Dr. Marks, Dr. Maltsberger, I think from Dr. Healy, I 11:33:50 7 believe I cross-examined one or two of their experts about 11:33:53 8 the fact that the FDA regulations, which are really only 11:33:57 9 minimum safeguards for the average patient, say they're 11:34:01 10 supposed to warn about risks without waiting for this 11:34:06 11 scientific proof positive from tests that they will never do 11:34:09 12 in the first place. 11:34:13 13 And the law in Wyoming says when you do it, you do it 11:34:16 14 in a manner which will bring home the message, which will get 11:34:19 15 the doctor's attention. That might require a black box. 11:34:28 16 Ladies and gentlemen of the jury, SmithKline Beecham 11:34:29 17 has failed to warn and I submit to you most respectfully that 11:34:34 18 you have the power and, with respect, the responsibility 11:34:38 19 under your oaths as jurors to render a verdict in this case 11:34:42 20 that will lead to such warnings. 11:34:44 21 We're not talking about removing Paxil from the 11:34:47 22 market. We're not a bunch of crazy zealots out here saying, 11:34:54 23 "This is a dangerous drug here. Get it off the market." 11:34:57 24 We're not saying that at all. 11:34:58 25 You heard Dr. Maltsberger yesterday. He said it was 21 11:35:01 1 a good drug, it helps people. Dr. Healy who courageously has 11:35:06 2 spoken out in the field of neuropsychopharmacology on behalf 11:35:11 3 of small, vulnerable people instead of on behalf of the 11:35:14 4 companies, he said, "I prescribe these drugs." 11:35:18 5 What we're talking about is empowering the 11:35:21 6 physicians. We're talking about you using your power of the 11:35:25 7 verdict to in turn empower the physicians throughout Wyoming 11:35:29 8 and the rest of these United States at least to have the 11:35:32 9 information that they need to safely use the drugs. 11:36:05 10 You know, there's nothing wrong with the old 11:36:05 11 antidepressants. We heard it yesterday from Dr. Merrell. 11:36:05 12 They're cheaper. For those of us who have to pay the 11:36:05 13 freight, they're cheaper than the others because they don't 11:36:05 14 have patent protection. But they work well. 11:36:05 15 Dr. Merrell said Don Schell should have been on 11:36:05 16 imipramine for all of these years. That's his view. 11:36:10 17 That's pretty much it about warnings. Let's talk 11:36:13 18 about testing for a minute. Prospective testing, an idea 11:36:20 19 whose time has come or should come in June of 2001. 11:36:28 20 August 8th to 15th, 1990, Dr. David Wheadon, now 11:36:33 21 vice-president of SmithKline Beecham, flew to Europe and the 11:36:36 22 experts there said, "The way to get a definitive handle on 11:36:39 23 this is to do prospective testing." Ten years later, last 11:36:44 24 November, I questioned him and the answers were read 11:36:47 25 yesterday from the stand: "We have never done that. We have 22 11:36:53 1 never done that." 11:36:54 2 Well, why haven't they done that? Let's look at his 11:37:05 3 memo. August 8 to 15, European consultants, potential 11:37:32 4 relationship between paroxetine treatment and suicidal 11:37:44 5 ideation or behavior. Each of the consultants felt that the 11:37:49 6 most definitive assessment would be by some sort of 11:37:50 7 prospective study. 11:37:52 8 And look, they said if a prospective study was done, 11:37:55 9 they recommend using a different suicide scale. Professor 11:37:59 10 mentioned someone by somebody. This is David Wheadon. This 11:38:02 11 is the vice-president of SmithKline Beecham writing this 11:38:04 12 memorandum. 11:38:11 13 That was August of 1990. The following spring -- if 11:38:17 14 I don't hit these right buttons, you will see nothing I've 11:38:21 15 planned for you -- Lilly told the FDA that it would proceed 11:38:26 16 with just such a study. Let's look at it. 11:38:46 17 May 13th, 1991 at the meeting Lilly agreed to do the 11:38:51 18 following: Proceed with a rechallenge study. We agreed to 11:38:54 19 have the rechallenge protocol ready to go by September 1st, 11:38:58 20 1991. 11:38:59 21 And when they did that study, guess what? They were 11:39:04 22 going to incorporate the modified scale for suicidal 11:39:08 23 ideation, MSSI-R, in other words, a different suicide scale. 11:39:15 24 You will see the Beck scale attached to Dr. Beasley's draft 11:39:18 25 study as Exhibit 39. 23 11:39:29 1 "But this is Lilly," they say. "How about us? We're 11:39:32 2 SmithKline Beecham?" Well, look at this. The FDA said they 11:39:39 3 should consult Drs. Teicher and Cole, but the FDA did not 11:39:44 4 have a problem if we gave the MSSI-R questionnaire to other 11:39:49 5 companies to use in their clinical trials. It is no big 11:39:53 6 trade secret. Dr. Wheadon didn't have to leave that 11:39:55 7 knowledge behind when he went over to SmithKline Beecham. He 11:39:58 8 could take it with him. 11:40:11 9 What's the deal with this Beasley study? It is not 11:40:14 10 really complex. It is Exhibit 39. And they said -- you 11:40:35 11 remember Dr. Wang talking about scientific ways of studying 11:40:38 12 things. There's the epidemiology and there's the randomized 11:40:42 13 control trial. Those are really the tools of real 11:40:45 14 scientists. 11:40:46 15 Well, look what a real scientist at Eli Lilly, 11:40:49 16 Dr. Wheadon's colleague, Dr. Beasley, said: Three different 11:40:54 17 basic approaches to the prospective assessment have been 11:40:58 18 considered: Numero uno, epidemiology studies but they're 11:41:03 19 subject to two major concerns, selection bias and confounding 11:41:06 20 bias. 11:41:21 21 He said -- he concluded, given the major concerns 11:41:24 22 with these biases, such a study design, epidemiology, would 11:41:31 23 not be the best approach. 11:41:33 24 So then he says numero dos. How about large 11:41:37 25 prospective double-blind parallel comparison trials? There's 24 11:41:41 1 several disadvantages with those. One of them is, given the 11:41:44 2 rarity of the event, extreme confidence in sample sizes based 11:41:51 3 on power calculations are suspect. The necessarily large 11:41:55 4 sample sizes would require many investigators. 11:41:58 5 These people want to try to persuade you that a 11:42:00 6 single study done by somebody else that they've partially 11:42:04 7 funded in Holland with 91 people, all but 19 of whom dropped 11:42:08 8 out, resolves the issue. 91 wouldn't be enough, but good 11:42:16 9 gracious me, 75 percent of the people dropped out of it. 11:42:21 10 Finally, they said even though a rechallenge study 11:42:26 11 has its own limitations, it is considered the best way to 11:42:29 12 study the issue. 11:42:47 13 SmithKline Beecham fell heir to that knowledge when 11:42:50 14 David Wheadon went to work there. And of course in the 11:42:53 15 following March of '92, Dr. Mann's ACNP paper came out and 11:42:59 16 outlines four study designs, three of which were prospective. 11:43:05 17 And isn't it a shame that someone with the obvious 11:43:09 18 knowledge of Dr. Mann who has written as much as Dr. Mann has 11:43:12 19 on this, twice I have deposed that man under oath and twice I 11:43:20 20 have said, "Have you looked at the Beasley study protocol so 11:43:23 21 we can talk intelligently about it?" I asked him here last 11:43:27 22 week, "Doc, have you looked at that yet so I can question you 11:43:30 23 about it?" 11:43:30 24 "No, I haven't read that." 11:43:37 25 Prospective studies: Have they done them? 25 11:43:41 1 Absolutely not. Three executives testified. Dr. Blumhardt: 11:43:47 2 "In terms of in-house testing or analysis, has it been 11:43:53 3 confined to retrospective analysis?" 11:44:01 4 "So far as I know," she says. "We've gone over 11:44:04 5 that." 11:44:04 6 "There were no prospective studies? It was all 11:44:07 7 retrospective?" 11:44:10 8 "At that time, that's correct." That's what she 11:44:12 9 said. 11:44:13 10 How about Dr. Ian Hudson, that British chap? I 11:44:17 11 asked, "Have you ever done a large-scale clinical study or an 11:44:20 12 epidemiological study to look at this issue." 11:44:28 13 He said, "We've looked at it with a number of 11:44:28 14 different tools." 11:44:28 15 I said, "But have you done one of these kinds of 11:44:30 16 studies?" Because I know what they're going to do, they're 11:44:33 17 going to hire a guy like Dr. Wang and say, "This is the only 11:44:35 18 way to study the issue." 11:44:37 19 So I asked the man, "Have you done it?" 11:44:39 20 He said, "We've evaluated it through a number of 11:44:42 21 different tools. If you're asking whether we've conducted a 11:44:44 22 randomized prospective study, that's an inappropriate way to 11:44:49 23 study the issue." 11:44:52 24 Isn't that weird? This guy is the worldwide director 11:44:56 25 of safety, worldwide, for SmithKline Beecham, and he says 26 11:44:59 1 that it is inappropriate to do the very thing that Dr. Mann 11:45:02 2 and Dr. Wang say is the way, the only way to do it. 11:45:12 3 Finally, of course, Dr. Wheadon. We've been over 11:45:15 4 that. You heard it yesterday. He agreed the most definitive 11:45:17 5 assessment is a prospective study, which they've never done. 11:45:27 6 They have done some look back over the shoulder, some 11:45:30 7 metaanalyses, but that doesn't answer the question, and it 11:45:33 8 doesn't answer the question because they weren't designed to 11:45:36 9 answer the question in the first place. They use those 11:45:41 10 single items, the Ham D and the MADRS instead of that 11:45:45 11 19-point Beck scale. 11:45:47 12 They were looking for a rare phenomenon. The 11:45:51 13 patients took other medications which masked the problems, 11:45:55 14 and of course Paxil redistributes the risk. That's the big 11:45:59 15 problem, helping some but harming others. 11:46:38 16 Three quick things: Remember Teicher and Cole in 11:46:38 17 '93, this guy Cole is a pioneer in the field of 11:46:38 18 psychopharmacology. Everyone agrees. And they write an 11:46:38 19 article about these drugs and said very specifically, "We're 11:46:42 20 particularly concerned with the possibility that 11:46:45 21 antidepressant drugs redistribute the risk." 11:47:06 22 Remember the letter to the editor written in response 11:47:08 23 to Dr. Mann's article that I asked him about? And I 11:47:17 24 apologize for this copy. It is not the best. But Theodore 11:47:21 25 Van Putten, the world expert on akathisia, wrote responding 27 11:47:25 1 to Dr. Mann's article and said, "Examining large placebo 11:47:28 2 controlled databases for treatment of emergent suicidal 11:47:33 3 ideation is not likely to be instructive because the active 11:47:37 4 treatment, even if it causes suicidal ideation in a subgroup, 11:47:42 5 also suppresses it. As long as the treatment suppresses more 11:47:46 6 than it causes, it is going to compare favorably." 11:48:06 7 Finally there's the Donovan study. They point out 11:48:09 8 the limitations that the author himself pointed out, but they 11:48:14 9 funded it. And what does it show? It shows that the risk of 11:48:23 10 deliberate self harm, the risk of deliberately harming 11:48:29 11 yourself, for imipramine, which worked so well for Don 11:48:35 12 Schell, is only 1.2, but for paroxetine, which is Paxil, 4.0; 11:48:43 13 almost four times as great. 11:48:45 14 Why did this man get a medication that was four times 11:48:49 15 riskier for him? Because these people didn't do the tests 11:48:53 16 and didn't do the warnings to alert his doctor. That's 11:48:57 17 exactly why. That's the Donovan study and they try to poke 11:49:23 18 holes in it even though they funded it. 11:49:25 19 I submit to you with great respect, SmithKline 11:49:30 20 Beecham has simply failed to test, and that's negligence 11:49:32 21 under the law. They failed to test. 11:49:39 22 Now, you, frankly, have the power and the 11:49:42 23 responsibility to render a verdict which will lead to tests 11:49:45 24 in the future. 11:49:48 25 Causation. We have to prove that this drug can cause 28 11:49:52 1 some people to become suicidal or violent by a preponderance 11:49:59 2 of the evidence, not by scientific studies that they have 11:50:04 3 never done and will never do, but by a preponderance of the 11:50:07 4 evidence that you find credible and that it was a cause, it 11:50:13 5 was one of the causes of the suicidal and homicidal behavior 11:50:16 6 of Don Schell. We have to tip the scales of justice ever so 11:50:20 7 slightly in our favor with the evidence that you have. 11:50:23 8 Is it the best evidence available in the world? 11:50:27 9 Yeah, it is. It is the best that's available. Could more be 11:50:32 10 available? You bet. They could have had more had they done 11:50:35 11 what a responsible company should have done a decade ago and 11:50:39 12 done the tests that their own vice-president acknowledged 11:50:43 13 they should have done. 11:50:44 14 But there is ample proof of causation in this case. 11:50:47 15 First of all, Exhibits 10 to 16, their own internal data, 11:50:51 16 shows this drug can cause these kinds of problem with some 11:50:54 17 people. 11:50:55 18 And secondly, there's the testimony of Dr. Healy on 11:50:57 19 the issue of general causation. Here is a loquacious man, 11:51:04 20 irrepressible Irish charm, I guess, a teacher, but an 11:51:13 21 incredibly courageous man. Have you got any idea how 11:51:18 22 courageous one must be to stand up if you're a 11:51:22 23 neuropsychopharmacologist, that's how you make your living 11:51:26 24 and your reputation, to stand up to a company like SmithKline 11:51:30 25 Beecham and say, "Hey, I used to work for you. I've done 29 11:51:33 1 some studies for you. I like your drug, but, by God, you're 11:51:37 2 not doing what you need to do. You're not telling people 11:51:40 3 what they need to know, particularly where 55 percent of the 11:51:43 4 people in the United States that are writing prescriptions 11:51:46 5 are not mental health care physicians." 11:51:51 6 You heard Dr. Merrell say it, "Boy, this guy should 11:51:54 7 have been seen by a psychiatrist." Well, whose fault is 11:51:57 8 that? Who has encouraged GPs like Dr. Patel to diagnose and 11:52:02 9 treat depression with this pill? These people have. 11:52:13 10 Dr. Healy said, "Nothing good known to man comes to 11:52:17 11 mankind from drugs that impact the 5HT2 receptor." Dr. Mann, 11:52:22 12 much to his chagrin, had to read from the first and only 11:52:26 13 textbook of suicidology that SSRI drugs affect the 5HT2 11:52:32 14 receptors, that causes akathisia, and akathisia causes 11:52:37 15 violence and suicide. 11:52:38 16 You recall the Yale study from January of 1991 11:52:41 17 talking about psychiatric admissions to the hospital. That 11:52:43 18 says, "The impact of SSRI drugs on the 5HT2 receptor causes 11:52:49 19 hallucinations like being on LSD." 11:52:55 20 He did research for SmithKline Beecham. Two of the 11:52:59 21 trials he did never made it public. He told you that Paxil 11:53:02 22 was more potent. He talked about the various kinds of 11:53:05 23 testing suggested by all of the different experts. He told 11:53:09 24 you about his own healthy volunteer study where 2 out of 20 11:53:16 25 perfectly healthy people taking Zoloft became suicidal, 30 11:53:21 1 actively suicidal on that drug, proving that SSRI drugs, 11:53:25 2 drugs that inhibit the reuptake of serotonin, do cause 11:53:28 3 suicidality. 11:53:32 4 He told you that the most effective way to study was 11:53:35 5 challenge/dechallenge/rechallenge, just like John Mann wrote, 11:53:40 6 A-B-A design; that randomized clinical trials do not work for 11:53:48 7 this for the reasons we've discussed, it helps some, hurts 11:53:51 8 others; he reiterated that SmithKline has done no prospective 11:53:56 9 study, although they did do the retrospective studies looking 11:53:59 10 for something that would not be found. And he also told you 11:54:02 11 that a vast amount of their material, inconvenient material, 11:54:07 12 was not published. 11:54:09 13 Remember his testimony about one of the published 11:54:11 14 studies by Dr. Baldwin and Dr. Montgomery? They published 11:54:15 15 other data but did not publish the suicide data. He just 11:54:19 16 happened to get it in a talk from Dr. Baldwin and told you 11:54:23 17 that data confirmed that there is a problem, that this drug 11:54:27 18 does cause suicide and violence for a small, vulnerable 11:54:30 19 subpopulation of people. 11:54:34 20 With respect to Don Schell, he told you his 11:54:37 21 assessment was the same as Dr. Maltsberger's, that he had 11:54:40 22 mild to moderate -- it is a major depression, but the 11:54:43 23 severity is mild to moderate. It is usually self limited, in 11:54:49 24 other words, limited in time; usually arose from a situation; 11:54:54 25 that he was more anxious on Paxil; that as a result of the 31 11:55:07 1 reaction to Prozac, he would likely have had the same 11:55:10 2 reaction to other drugs. 11:55:12 3 We get now to the questions you will be asked by the 11:55:14 4 Court, things that you have to fill out. First question: 11:55:19 5 Can Paxil cause some people to commit, some people, to commit 11:55:25 6 homicide or suicide? 11:55:27 7 From the best available evidence in the world, the 11:55:30 8 answer to that question is yes, it can. 11:55:38 9 And question number 2 is well, was that a cause of 11:55:42 10 Don Schell's homicides and suicide? Yes. 11:55:46 11 Were other factors at play? Probably. Dr. Mann says 11:55:50 12 it is multi-factorial. I don't dispute that. But was one of 11:55:54 13 the causes, was the biological trigger he says is always 11:55:58 14 there? The Paxil is the only explanation. Dr. Maltsberger 11:56:02 15 said it yesterday, "In 41 years I've never seen a 60-year-old 11:56:07 16 man go nuts and murder people without some organic reason, 11:56:11 17 some biological reason." 11:56:15 18 When you get your verdict form, for us to win this 11:56:19 19 case we have to prove by a preponderance of the available 11:56:22 20 evidence that you should say yes and yes to questions 1 and 11:56:26 21 2. 11:56:31 22 I need to move along because I need to save some time 11:56:38 23 for my colleague, Mr. Fitzgerald, in rebuttal. 11:56:39 24 On your verdict form you will see there's a 11:56:41 25 comparative fault question and it will ask was SmithKline 32 11:56:45 1 Beecham at fault under the law, and how about Don Schell? 11:56:48 2 Now, honestly I don't think Don Schell did a thing in 11:56:51 3 the world wrong, but from all of the evidence before you you 11:56:54 4 could say, "Well, maybe he ought to bear some percent of the 11:56:58 5 responsibility." Our suggestion is certainly 95 percent of 11:57:02 6 the responsibility or more is on SmithKline Beecham in this 11:57:05 7 case. 11:57:09 8 The defense has been, as you've seen, to blame Don 11:57:12 9 Schell. We ask you by your verdict to clear Don Schell's 11:57:17 10 good name. 11:57:18 11 Don't have a ton of time. I need to talk to you 11:57:21 12 about damages. 11:57:24 13 Magic and money. Wish I didn't. Don't like that. 11:57:31 14 Don't like that. Wish I had a different commodity. Wish I 11:57:35 15 had different power. Wish I had the power of the 11:57:38 16 resurrection. I guarantee you this man right down here at 11:57:43 17 the end of this table and this one right here would walk out 11:57:46 18 of this courtroom in a heartbeat if we had had that kind of 11:57:49 19 magical power. We could wave this little light saber better 11:57:53 20 and bring these four people back to life. 11:57:57 21 Forget the fame, forget the verdict, forget the 11:58:01 22 money. If we had that kind of magical power, if I could 11:58:05 23 restore to this guy right here, who I have come to love in 11:58:08 24 the last three weeks, his wife and his child, I would do it 11:58:12 25 in a heartbeat. But I don't have that power. I don't have 33 11:58:16 1 that magic, and you don't either. 11:58:21 2 All you've got is the power of your verdict and all 11:58:25 3 that the law allows you to do in rendering a verdict is to 11:58:29 4 award money, to award money. So how much money? You know, 11:58:38 5 it is my responsibility -- one of you asked in the jury 11:58:42 6 selection process, a couple of you actually talked about it 11:58:45 7 and you said, "We think we could award damages in this case, 11:58:48 8 but we would want some guidance. We would want some guidance 11:58:53 9 from you." 11:58:54 10 You're going to get it. They won't like it, but 11:58:56 11 you're going to get it. It is our obligation, it is 11:59:01 12 Mr. Fitzgerald's obligation and my obligation. It is our 11:59:06 13 obligation to these people and these people, it is our 11:59:09 14 obligation to those out in the future that we don't want 11:59:12 15 written down to zero to talk to you about the unpleasant 11:59:17 16 subject of money. That's all we've got to give them. Can't 11:59:21 17 give them anything else. 11:59:24 18 We want to be fair to them, too. We want a verdict 11:59:27 19 that will be fair to SmithKline Beecham. What should it be? 11:59:34 20 You will get a damages question. It will ask about the 11:59:40 21 damages for each of the four people that were deceased and 11:59:43 22 for claims with regard to each of them. 11:59:46 23 For the wrongful death of Deborah Tobin, damages for 11:59:50 24 her husband, Timothy Tobin -- where does this come from? The 11:59:54 25 judge will instruct you, there's no formula. There's no 34 11:59:58 1 expert that can give it to you. What this comes from is a 12:00:02 2 combined experience of about 55 years of being a lawyer. I 12:00:07 3 think that's 50 for Jim and 5 for me -- not quite. We each 12:00:14 4 have tried 50 cases. We've tried 50 jury cases. This comes 12:00:19 5 from our experience and assessment of this evidence. 12:00:29 6 I submit to you all the money in the world wouldn't 12:00:32 7 bring them back. $10 million for each of these deaths 12:00:39 8 wouldn't be too much, but I'm asking you to award 6,445,000 12:00:44 9 to this man for the death of his wife and to this man for the 12:00:48 10 death of his daughter, and a similar amount for the wrongful 12:00:51 11 death of Rita Schell, to her sisters and to her son and to 12:00:55 12 her mother. 12:01:00 13 And finally, for the death of Donald Schell, you 12:01:03 14 know, if you answer that fault question and you say Don 12:01:06 15 Schell was 51 percent at fault, his son Michael doesn't get a 12:01:10 16 penny. Otherwise, they're responsible for whatever 12:01:15 17 percentage you put on it. 12:01:16 18 Michael Schell, unfortunately, is not blessed with 12:01:20 19 the wonderful expressive vocabulary that this woman and both 12:01:25 20 of her sons have. He's not quite as good at putting into 12:01:31 21 words the effect on him of the loss of the comfort and 12:01:35 22 society and companionship of his parents. 12:01:38 23 He's a clean-spoken man, a ranchhand, a Wyoming man. 12:01:44 24 But you know what he said? He said, "Things just come harder 12:01:52 25 to me now. They just come harder." And that spoke volumes 35 12:01:58 1 to my soul. They come harder to him because he's lost his 12:02:03 2 mother and his father in a tragic way. And I ask you to 12:02:15 3 award a similar amount of money. 12:02:16 4 Now, people are saying, "That's a lot of money. 12:02:21 5 That's a lot of money. You're talking about an awful lot of 12:02:24 6 money. Maybe in New York, maybe in Philadelphia, maybe in 12:02:27 7 San Francisco, maybe even down in Houston where you live, 12:02:31 8 Andy Vickery, maybe a jury there might award that kind of 12:02:35 9 money, but this is Wyoming. We're conservative people here." 12:02:40 10 Well, listen to what they say. See what he proposes. 12:02:44 11 See if he proposes something that's reasonable to you and 12:02:48 12 then use your own good judgment about what type of verdict 12:02:51 13 should be appropriate under this case. 12:02:58 14 I have found that the people of Wyoming love life and 12:03:04 15 they appreciate the simple comforts. When they say, "We've 12:03:09 16 lost our comfort and companionship and society in the 12:03:12 17 future," that they know just what they're talking about. 12:03:36 18 Enough of the Power Points. Enough of the slides. I 12:03:42 19 got to sit down and shut up in a few minutes. That's a real 12:03:46 20 hard thing for me to do, a real hard thing for me to do, 12:03:52 21 because I have devoted whatever energies and God-given 12:03:57 22 talents I may have to speaking on behalf of small, vulnerable 12:04:02 23 people in our society for 28 years and for these people for 12:04:05 24 the last couple, and it is hard for me to take off that old 12:04:11 25 cloak of justice seeker and give it to someone else. 36 12:04:17 1 But I have enough confidence in this process and you 12:04:23 2 to do precisely that. I am not going to seek justice for 12:04:28 3 them anymore. I'm going to sit down and shut up. I'm not 12:04:32 4 going to say another word. After lunch you'll hear from some 12:04:36 5 very fine lawyers whose obligation it is to represent 12:04:40 6 SmithKline Beecham, and they've worked hard to do that and 12:04:42 7 I'm sure they'll have some perspective. 12:04:44 8 And then finally, because we have the burden of 12:04:47 9 proof, you will hear from one of Wyoming's finest. He always 12:04:52 10 wears a maroon tie to trial. He doesn't wear buckskin like 12:04:57 11 the more famous guy in the northwestern portion of your 12:04:59 12 state, or a ten-gallon hat, but here is a true seeker of 12:05:04 13 justice. And I think that when he sums up the evidence for 12:05:08 14 you at the end, you will appreciate and understand his 12:05:16 15 perspectives as well. 12:05:17 16 Lawyers like to thank jurors for their jury service. 12:05:20 17 I'm a little weird about that. You see, if I were 12:05:24 18 representing any of you, I wouldn't hesitate a heartbeat to 12:05:29 19 make this man or this woman sit in these chairs for three 12:05:34 20 weeks to judge your case. I think it is a civic 12:05:38 21 responsibility and a privilege and an honor. 12:05:42 22 You have the power and the responsibility to do 12:05:44 23 justice in this case, justice that will see that other people 12:05:49 24 aren't written down to zero, justice to render a statistic 12:05:54 25 that is not statistically insignificant, justice for these 37 12:05:59 1 four innocent people right here. I hope and I pray that you 12:06:06 2 will do that. 12:06:07 3 I ask you from the bottom of my heart to give your 12:06:10 4 verdict to the plaintiff in this case. Because it is sad? 12:06:15 5 No. Because you have sympathy for us? No. There are plenty 12:06:19 6 of people that are sympathetic with this family. But because 12:06:24 7 it is the just and the right thing to do. 12:06:27 8 I never get to this point in a trial that I don't 12:06:29 9 think about the closing scene in a movie called Philadelphia. 12:06:36 10 Some of you may have seen it. Tom Hanks was a lawyer and he 12:06:42 11 was dying of AIDS and became a plaintiff like Tim suing a law 12:06:46 12 firm that fired him. 12:06:47 13 Right at end of the trial he's sitting in the witness 12:06:50 14 stand and his lawyer says to him, "Why did you become a 12:06:53 15 lawyer?" You know, everybody likes lawyer jokes. "Why did 12:06:56 16 you become a lawyer?" 12:06:56 17 He said, "I'll tell you why: Because when you really 12:07:01 18 work hard, it doesn't happen often, doesn't happen always, 12:07:06 19 but every so often when you really work hard and you 12:07:10 20 participate in the judicial process, you are part of justice 12:07:15 21 being done and that's a mighty good feeling." 12:07:20 22 I pray for each of you you will have that feeling the 12:07:24 23 rest of your lives. Thank you. 12:07:27 24 THE COURT: Thank you, Mr. Vickery. 12:07:29 25 Ladies and gentlemen, we will take our noon recess at 38 12:07:32 1 this time, and I believe it worked out for you to have lunch 12:07:38 2 together. Because that's going to take a little bit more 12:07:41 3 time, we will adjourn until 1:30 p.m. this day. 12:07:46 4 Please remember the admonition the Court has given 12:07:52 5 you throughout this trial. Court will stand in recess. 12:07:55 6 (Trial proceedings recessed 12:05 p.m. 12:08:06 7 and reconvened 1:40 p.m., June 5, 2001.) 14:05:21 8 THE COURT: The defendant may commence its closing 14:05:21 9 arguments. 14:05:21 10 MR. PREUSS: Thank you, Your Honor. 14:05:21 11 Your Honor, Counsel, members of the jury. Good 14:05:21 12 afternoon. Tom Gorman, I, and the rest of our team would 14:05:21 13 like to thank you for the opportunity to present SmithKline's 14:05:21 14 position in this case. 14:05:21 15 When I made my opening remarks a couple of weeks ago, 14:05:21 16 I expressed the belief that the facts, the science and your 14:05:21 17 common sense would lead you to the conclusion that two Paxil 14:05:21 18 pills had nothing to do with the murder/suicide that occurred 14:05:21 19 in Gillette in February of 1998. Rather, it was Don Schell's 14:05:21 20 depression history and his terrible bout in February of 1998 14:05:21 21 that led to this terrible crime. 14:05:21 22 What I would like to do this afternoon is to show you 14:05:21 23 how the evidence establishes that Paxil had nothing to do 14:05:21 24 with this case. Rather, it was Don Schell's depression that 14:05:21 25 led to this tragedy. 39 14:05:21 1 Let's start with depression. Depression is the 14:05:21 2 underlying factor in this entire case. We know from Dr. Mann 14:05:21 3 and Dr. Merrell that depression is a terrible, terrible 14:05:21 4 disease. It is crippling, it is disabling. It is despair 14:05:21 5 beyond despair, Dr. Merrell told us. 14:05:21 6 15 percent of our adult population experiences 14:05:21 7 depression in their lifetime. 15 percent of those seriously 14:05:21 8 depressed take their lives each year. 30,000 suicides occur 14:05:21 9 on an annual basis, many of those, most of those, in fact, 14:05:21 10 are men, particularly as they get older. A thousand 14:05:21 11 murder/suicides occur each year. Dr. Mann told us that it is 14:05:21 12 the largest source of disability in the country, keeping 14:05:21 13 people away from work and nonproductive. 14:05:21 14 Unfortunately, as we learned, there is a stigma 14:05:21 15 attached to mental illness. Many men think it is unmanly, 14:05:21 16 think they can handle it and control it on their own. It is 14:05:21 17 something they're embarrassed about so they keep it from 14:05:21 18 other people, even their families. Don Schell was one of 14:05:21 19 those men who felt the stigma of mental illness. 14:05:21 20 The result is that many people who need help with 14:05:21 21 mental illness do not get help. Dr. Wang told us that 84 14:05:21 22 percent of the people that have depression do not get 14:05:37 23 treatment at any time and that those that do, it takes up to 14:05:37 24 ten years before they seek their first treatment. 14:05:37 25 Others go undertreated. 60 percent of individuals 40 14:05:37 1 who are untreated commit suicide. Don Schell was one of 14:05:37 2 those that was untreated or undertreated. 14:05:37 3 As we have learned, Paxil is a treatment for 14:05:37 4 depression. It is a safe and effective medication for 14:05:37 5 depression and anxiety. It has been used successfully for 14:05:37 6 millions of people over the past eight years. It reduces 14:05:37 7 anxiety, it reduces depression, and it reduces aggression. 14:05:37 8 Simply put, it saves lives, not only the lives of those 14:05:37 9 people afflicted with mental illness, depression in 14:05:37 10 particular, but those who work and live in the environments 14:05:37 11 of those people who are depressed. Given time to be 14:05:37 12 effective, Paxil could have saved four lives in Gillette in 14:05:37 13 February of 1998. 14:05:37 14 Let's talk a little bit about Paxil and its 14:05:37 15 development and its testing. David Wheadon, you probably 14:05:37 16 recall, he was here on a Friday, I think, before the long 14:05:37 17 weekend that we all had. He's vice-president of regulatory 14:05:37 18 affairs and product services and he expressed what the 14:05:37 19 company's philosophy is. 14:05:37 20 And to paraphrase, he said, "It is our mission to 14:05:37 21 responsibly and appropriately discover and develop drugs that 14:05:37 22 make a difference in the lives of patients and treatments 14:05:37 23 that target unmet needs of patients suffering from diseases 14:05:37 24 in a scientifically rigorous fashion." 14:05:37 25 That philosophy emanates from J. P. Garnier, the 41 14:05:37 1 current CEO of the company, himself a Ph.D. in pharmacology. 14:05:37 2 Paxil is one of the drugs that meets the unmet needs of 14:05:37 3 people with depression. 14:05:37 4 Taki Yamada, you saw him by video depo, the head of 14:05:37 5 research and development, told us that the company decisions 14:05:37 6 are based on patient needs, not business consideration. 14:05:37 7 Let's take a look at how Paxil was developed. You 14:05:37 8 recall that I discussed the Paxil story with David Wheadon. 14:05:37 9 It begins in 1980s where over a thousand, approximately 1500 14:05:37 10 healthy volunteers took Paxil initially, healthy volunteers 14:05:50 11 meaning people like you and myself that are healthy, nothing 14:05:50 12 wrong, they're given Paxil, they want to see what happens. 14:05:50 13 All studies indicated no homicide, no suicidal 14:05:50 14 ideations, no homicidal ideations, no attempted suicide, no 14:05:50 15 attempted homicide. 14:05:50 16 Then it was tested clinically with Paxil and 14:05:50 17 depressed people, over 2,000 initially, and the NDA, which is 14:05:50 18 a new drug application that every company has to submit to 14:05:50 19 our Food & Drug Administration, was submitted in November of 14:05:50 20 '89 for approval for depression. 14:05:50 21 During the process, 1990, there were some case 14:05:50 22 reports published on Prozac, and we've heard about those. 14:05:50 23 The Teicher report I think you will remember. And 14:05:50 24 immediately SmithKline, Dr. Blumhardt, began to focus on 14:05:50 25 review of that data that we had at that time on suicide. 42 14:05:50 1 The analysis was completed, sent to the FDA in April 14:05:50 2 of 1991 and in June of 1991 the FDA concluded that there was 14:05:50 3 no signal of suicidality in the Paxil data. 14:05:50 4 Meanwhile, the company was working on a prospective 14:05:50 5 study labeled par 057 study, an ongoing extensive study that 14:05:50 6 stretched out over a couple of years. 14:05:50 7 Even after the FDA informed SmithKline that there was 14:05:50 8 no signal from our data, we heard about the FDA advisory 14:05:50 9 committee from Dr. Mann in the last couple days -- last week, 14:05:50 10 and he was the head of that, mainly focused on Prozac, but 14:05:50 11 there was data in there from Paxil, I think you heard him 14:05:50 12 say, and it was unanimous, 9 to zero, that there was no 14:05:50 13 credible evidence that SSRIs cause the emergence or 14:05:50 14 intensification of suicide or violence, and indeed, that no 14:05:50 15 label change was needed. 14:05:50 16 Meanwhile, shortly thereafter, the FDA approved Paxil 14:05:50 17 as an indicated use for depression. The par 57 study in 14:05:50 18 October of '94 was completed and in December of '94 a new 14:05:50 19 drug application on obsessive-compulsive disease was 14:05:50 20 submitted to the FDA involving 452 patients. 14:05:50 21 In' 95 another NDA was submitted for panic disorder 14:06:08 22 to the FDA, 469 patients. These are all randomized control 14:06:08 23 double-blind studies where safety is looked at at every step. 14:06:08 24 Safety would include people with suicide attempts, suicide 14:06:08 25 thoughts, suicidal ideation, homicidal thoughts. That would 43 14:06:08 1 be encompassed in every new drug application. 14:06:08 2 Independent analysis in June of '95 to look at 14:06:08 3 suicidality and particularly with respect to the database 14:06:08 4 established for OCD. 14:06:08 5 1996, another review of suicidal ideation and 14:06:08 6 aggression was conducted. In 1996, two new approvals 14:06:08 7 submitted for obsessive-compulsive disease and for panic 14:06:08 8 disorder were approved by the FDA. 14:06:08 9 A new NDA for social anxiety disorder in May of 1998. 14:06:08 10 More randomized control clinical studies. 14:06:08 11 1999, FDA approved social anxiety disorder. 14:06:08 12 SmithKline reviewed its database for aggression. 14:06:08 13 In 2000 that same database was reviewed with new data 14:06:08 14 that was forthcoming in the last year. That report, I spoke 14:06:08 15 with Dr. Marks about that and we discussed that on several 14:06:08 16 instances with Dr. Wheadon. 14:06:08 17 New NDA submitted that same year for anxiety 14:06:08 18 disorder, 735 patients, and also another one for traumatic 14:06:08 19 stress disorder to the FDA. 14:06:08 20 In 2001 the FDA approved generalized anxiety 14:06:08 21 disorder. 14:06:08 22 Now, in August of 2000 the healthy volunteer data was 14:06:08 23 rereviewed and reported again to the FDA. Now, that ties way 14:06:08 24 back to the start. That was rereviewed and that was because 14:06:08 25 of Dr. Healy's publication in his study. The FDA asked us 44 14:06:08 1 for that data and it was submitted to the FDA at that time. 14:06:08 2 Lastly, the year 2001, additional data on the deaths 14:06:08 3 and suicide, all the clinical data was sent to the FDA for 14:06:08 4 their analysis. 14:06:08 5 What I presented to you there was the company's side 14:06:08 6 of the story. What I would like to do with you now is to 14:06:08 7 take a look at what evidence we have from outside scientists 14:06:08 8 looking at our data. 14:06:08 9 And before doing that, remember we had a lot of 14:06:08 10 discussion about the differences among the SSRIs. There were 14:06:21 11 definitely similarities and there were definitely 14:06:21 12 differences, and each one has to be examined separately. 14:06:21 13 A good example was given in the case of zimelidine. 14:06:21 14 Zimelidine for whatever reason developed the side effect of 14:06:21 15 GBS, Guillain-Barre syndrome. Why it did nobody knows, but 14:06:21 16 it never made it to the market. 14:06:21 17 That is why you need to look at each drug separately. 14:06:21 18 If you want to know about Paxil, you have to examine Paxil. 14:06:21 19 You can't take Prozac data, go to the FDA and get an approval 14:06:21 20 for Paxil. You have to do it with your own data. That's the 14:06:21 21 data that was submitted. 14:06:21 22 Now, plaintiffs claim that Paxil causes suicide, 14:06:21 23 homicide, albeit in a small, undefined population. If you 14:06:21 24 recall Dr. Wang when he testified, he said that this was a, 14:06:21 25 quote, wrong claim, end quote. I would translate that as a 45 14:06:21 1 false or bogus claim because it is not based on solid 14:06:21 2 science. And let's see why. 14:06:21 3 The stage is set back in 1991. You recall there was 14:06:21 4 the FDA advisory committee. Before that was the Teicher case 14:06:21 5 reports that prompted Tina Blumhardt, Dr. Blumhardt, to take 14:06:21 6 a look at our suicide database before we even got approval. 14:06:21 7 In 1991, Dr. Mann -- and this article was discussed 14:06:21 8 and I'll just -- The Emergence of Suicidal Ideation and 14:06:21 9 Behavior During Antidepressant Pharmacotherapy. He had read 14:06:21 10 the Teicher reports too. He said, "I don't think there's 14:06:21 11 anything there, but we need to get more data on it." That 14:06:21 12 was something that he published in that article. 14:06:21 13 The FDA advisory committee, we discussed that. They 14:06:21 14 were unanimous it didn't cause suicide or homicide, but let's 14:06:21 15 take a further look at it. 14:06:21 16 The ACNP task force, Dr. Mann was one of four and I 14:06:21 17 think the principal one on that, and they found no evidence 14:06:21 18 that SSRIs increase the risk of suicide in any subpopulation, 14:06:21 19 and that they do provide significant benefit. 14:06:21 20 But he recommended further studies, as you recall, 14:06:21 21 and there were four different categories in which he did it. 14:06:21 22 So let's take a look at what outside scientists have said 14:06:37 23 about Paxil and suicide and homicide. 14:06:37 24 You will recall that this chart was prepared by 14:06:37 25 Dr. Wang and he told us how you establish causation between a 46 14:06:37 1 particular drug and a particular side effect. 14:06:37 2 He said, "First you have to ask the questions." And 14:06:37 3 the questions, as we had discussed, were Teicher reemphasized 14:06:37 4 by the Mann article, reemphasized by the FDA, reemphasized by 14:06:37 5 the ACNP, it can be done by animal studies, case reports, can 14:06:37 6 be done by observational studies, but to cross this river 14:06:37 7 with answers, what you need is randomized control trials. 14:06:37 8 They're the best, double-blind randomized prospective control 14:06:37 9 trials. 14:06:37 10 And he went through all of these studies -- 14:06:37 11 Lopez-Ibor, Montgomery study. These are metaanalysis. He 14:06:37 12 said that was the best way to do it, you take existing 14:06:37 13 clinical data and put it together and analyze it. And it is 14:06:37 14 all prospective studies, you're just taking a secondary look 14:06:37 15 at it and you can get an answer very promptly by amassing the 14:06:37 16 data. 14:06:37 17 Each one of these articles, each one of these 14:06:37 18 articles, and as well as our own internal Paxil healthy 14:06:37 19 volunteer studies established that Paxil does not cause 14:06:37 20 suicide, does not cause homicide, suicidal thoughts, suicidal 14:06:37 21 ideations, suicide attempts, homicidal thoughts or homicide 14:06:37 22 attempts, all of these studies. 14:06:37 23 And specifically as to the issue of whether there is 14:06:37 24 a small group, a subpopulation undefined, whatever, 14:06:37 25 particularly the Lopez and Montgomery studies and the healthy 47 14:06:37 1 volunteer studies confronted that, looked at it and found 14:06:37 2 nothing, no increased risk in that area. 14:06:37 3 He also discussed that you can use an observational 14:06:37 4 study that isn't randomized and isn't controlled -- it is 14:06:37 5 controlled but it is not randomized so everybody knows who is 14:06:37 6 getting what if you adjust for bias. 14:06:37 7 Then Dr. Mann testified, and you remember the article 14:06:37 8 that we had, and he made some recommendations. Again, I had 14:06:37 9 him write down there what are the questions and he talked 14:06:37 10 about metaanalysis. Again, Paxil, he cited to the Lopez-Ibor 14:06:37 11 study, the Montgomery study, Dunner and Kumar and Kahn. And 14:06:50 12 then the second category, epidemiologic studies -- Inman, 14:06:50 13 Isaccson study, Inman, over 13,000 people involved in that 14:06:50 14 study between 1991 and 1993. 14:06:50 15 All of these people are looking at the question that 14:06:50 16 was asked earlier. All of these people are coming up with 14:06:50 17 the same answer. 14:06:50 18 The third category, nondepressed populations, that's 14:06:50 19 the third category we discussed; nothing in that data. 14:06:50 20 Lastly, placebo control; Moeller and Steinmeyer, two 14:06:50 21 applications, and the Verkes study which was an outgrowth of 14:06:50 22 par 057 there, a one-year study, so there you have a review 14:06:50 23 of the scientific literature. And the conclusion is the same 14:06:50 24 as Dr. Mann and Dr. Wang said, that Paxil does not cause 14:06:50 25 suicide or homicide in any population group, small, large or 48 14:06:50 1 somewhere in between. 14:06:50 2 Well, what do the plaintiffs have to offer in terms 14:06:50 3 of Paxil causing suicide or homicide in some population 14:06:50 4 group? They have nothing, zero. Nothing. If you listen to 14:06:50 5 their evidence, their evidence was all focused on all of the 14:06:50 6 machinations going on between 1990 and 1992 when these 14:06:50 7 questions were being asked, the questions of Dr. Wheadon, 14:06:50 8 Dr. Mann. Dr. Wheadon, I thought he was a Lilly employee the 14:06:50 9 way they were asking questions. All of the questions had to 14:06:50 10 do with when he was at Lilly, when all the questions were 14:06:50 11 being asked, not after the questions were being asked when 14:06:50 12 the science was being done and when the science was showing 14:06:50 13 categorically study after study that Paxil doesn't cause 14:06:50 14 suicide or homicide in any population group. 14:06:50 15 The only thing that they have to offer on the 14:06:50 16 causation side is the Donovan study. Now, the Donovan study 14:06:50 17 is an observational study that Dr. Wang told us about, and it 14:06:50 18 is not adjusted for bias. And I don't have to criticize the 14:06:50 19 study at all because the authors do it for me. 14:06:50 20 I mean, it is not that Donovan -- I'm not criticizing 14:06:50 21 the Donovan study. It is fine as far as it goes. It is an 14:06:50 22 observational study that is biased. It doesn't deal with 14:06:50 23 suicide. It deals with deliberate self harm, which is not a 14:07:05 24 proxy -- the author's word -- for suicide, and it is biased 14:07:05 25 because people at the greatest risk are given SSRIs, in this 49 14:07:05 1 case Paxil, if you want to isolate the Paxil data, because 14:07:05 2 Paxil is less likely to cause any harm if it is overdosed. 14:07:05 3 The comparative drug that was more favorable does 14:07:05 4 have that propensity, so as the authors say, the prescribers 14:07:05 5 are heeding the advice to prescribe safer-in-overdose 14:07:05 6 antidepressants in patients who are perceived to be at 14:07:05 7 greater risk of DSH. 14:07:05 8 When you do that, there's nothing wrong with it and 14:07:05 9 you want to make sure you protect your patients. This 14:07:05 10 effectively loads the dice against antidepressants such as 14:07:05 11 the SSRIs so that this manifests as an apparent excess of 14:07:05 12 self-harm behavior. The author says, "I understand it is 14:07:05 13 biased. It is biased, but here's my data," and then they go 14:07:05 14 on to conclude that you can't establish cause and effect from 14:07:05 15 that study. It is almost impossible. 14:07:05 16 So as Dr. Wang has told us, the Donovan study stays 14:07:05 17 on the question side of the river. The bias has not been 14:07:05 18 adjusted. It does not cross the river. So the only data we 14:07:05 19 have to look at on the issue, in addition to the company 14:07:05 20 data -- all of which is in the FDA and available for people 14:07:05 21 like Drs. Kahn, Montgomery, Lopez-Ibor, all looked at the 14:07:05 22 data, looked at it on their own and came up with their own 14:07:05 23 results -- all of that data says Paxil does not cause suicide 14:07:05 24 or homicide. 14:07:05 25 Not only is there not a study, but the plaintiffs, 50 14:07:05 1 each one of their experts, the three experts were asked the 14:07:05 2 question. They can't cite to a single case report which only 14:07:05 3 would raise a question to the effect that Paxil causes -- to 14:07:05 4 suggest the question that Paxil might cause suicide or might 14:07:05 5 cause homicide. Not a single case report for none of them. 14:07:05 6 All right. I would like to talk about the 14:07:05 7 plaintiff's experts for a while. You've heard experts on 14:07:05 8 both sides and you have to weigh the credibility one way or 14:07:05 9 the other way. That's your job. 14:07:05 10 I want to talk a little bit about Dr. Healy. Now, I 14:07:18 11 questioned him on several of his articles. The first one was 14:07:18 12 his '99 article. And I want to focus on the word 14:07:18 13 "possibility." Possibility is not probability. Possibility 14:07:18 14 is not more likely than not. 14:07:18 15 So I asked him some questions, you might remember, 14:07:18 16 and asked him, "Well, is that your statement in your 14:07:18 17 article?" 14:07:18 18 And he said, "Yeah, yeah, that was my statement," and 14:07:18 19 told me that I needed to consider the context of how one 14:07:18 20 writes scientific articles. And he went on to say if he were 14:07:18 21 a Republican from Wyoming trying to get some proposal through 14:07:18 22 the Clinton-Gore White House, one would frame the issues in a 14:07:18 23 way that didn't raise the hackles of the people reviewing the 14:07:18 24 articles. 14:07:18 25 And so I asked him, I said, "Are you telling me you 51 14:07:18 1 didn't mean what you said?" 14:07:18 2 And he goes on to tell me, "No, I knew I would get 14:07:18 3 into print given that many of the reviewers of this article 14:07:18 4 are going to be consultants to the pharmaceutical industry." 14:07:18 5 And then he went on to say that in writing the article it was 14:07:18 6 a political compromise. 14:07:18 7 So then I went on and ask him about his article year 14:07:18 8 2000. We're not talking very long ago. And again, you will 14:07:18 9 see he's talking about possibilities. I asked him about 14:07:18 10 possibilities and I said, "Is this what you said?" 14:07:18 11 And he goes on to tell me, "Now, what I'm saying 14:07:18 12 quite clearly is that other SSRIs probably will induce 14:07:18 13 suicidality," even though he used the word "possibility" and 14:07:18 14 he agreed that he used that word "possibility." 14:07:18 15 So then I read to him a portion of his deposition 14:07:26 16 and, in particular, I said, "Now -- this is his testimony -- 14:07:29 17 "Now, a possibility -- there are scientific conventions which 14:07:33 18 broadly speaking say it is probable that the earth is round. 14:07:36 19 They leave open the possibility that the earth may be flat. 14:07:40 20 It is very rare in any scientific article to have people make 14:07:45 21 absolute black and white statements, so you've got to 14:07:47 22 interpret the phrase here as being dictated by the scientific 14:07:51 23 convention which is the possibility there are other SSRIs 14:07:54 24 that may cause similar problems." 14:07:57 25 The possibility that there are other SSRIs that may 52 14:08:01 1 cause a similar problem. So I asked him about that. That's 14:08:05 2 what he said. I said, "So just like the earth may be flat, 14:08:11 3 it is possible that Paxil may cause some suicide?" 14:08:14 4 And he then says, "It is the other way around. In a 14:08:18 5 scientific article I would say it is possible that the earth 14:08:21 6 was round and the jury would understand that I mean 14:08:24 7 absolutely for certain the earth is round, in the same way 14:08:28 8 I'm saying that other SSRIs make people suicidal and I expect 14:08:32 9 the jury to understand that I mean it is absolutely certain 14:08:37 10 that other SSRIs cause people to commit suicide and 14:08:47 11 homicide." 14:08:48 12 Then I asked Dr. Healy whether he had written 14:08:52 13 anything in the literature about Paxil causing suicide or 14:08:55 14 homicide and he admitted that he had not. 14:08:59 15 Now, we heard a little bit about the Beasley study 14:09:04 16 this morning, and the Beasley study was an article that was 14:09:10 17 discussed by Dr. Healy in his '94 article and about three 14:09:20 18 years after the initial reports from Teicher. 14:09:25 19 And you will see there on the left, it says, "In 14:09:28 20 reply to the case reports that fluoxetine induced 14:09:32 21 suicidality, Beasley and colleagues scrutinized the Eli Lilly 14:09:37 22 database for evidence of increased suicidality in patients 14:09:41 23 receiving fluoxetine." 14:09:43 24 MR. VICKERY: Your Honor, I object. I don't mean to 14:09:44 25 interrupt you. This is not the Beasley rechallenge protocol. 53 14:09:48 1 This is a Beasley metaanalysis. I object that counsel 14:09:52 2 misstated what my argument was. This is not the Beasley 14:09:55 3 rechallenge. There's a study that wasn't done and a 14:09:59 4 metaanalysis that was published. 14:10:04 5 MR. PREUSS: All I said, Your Honor, is that Beasley 14:10:06 6 was discussed today, and so I just am making reference to the 14:10:10 7 Beasley reference here, not any broader than that. 14:10:13 8 THE COURT: Very well. Proceed. 14:10:14 9 MR. PREUSS: I apologize if I misstated something. 14:10:19 10 He goes on to say, "No such evidence has been found. 14:10:23 11 These data from several thousand patients and evidence that 14:10:27 12 fluoxetine reduces suicidal ideation must on any scientific 14:10:31 13 scale outweigh the dubious evidence of a handful of case 14:10:34 14 reports." 14:10:35 15 And that's what Dr. Healy is saying in 1994, so I 14:10:41 16 talked to him about it and asked him. He said, "I'm making 14:10:44 17 that statement ironically. I was just poking fun at the way 14:10:48 18 the issue had been handled by Lilly." 14:10:52 19 And, by the way, in that report you see on the right 14:10:55 20 he concedes the case reports are clearly an unreliable form 14:11:00 21 of information and again indicates that the Teicher reports 14:11:06 22 were clearly compromised on many of the criteria he felt were 14:11:08 23 important before you could give any credence to a case report 14:11:11 24 in raising a question about whether a certain side effect was 14:11:16 25 connected with a disease or with a drug. 54 14:11:20 1 Now, Dr. Healy did not read all of the medical 14:11:24 2 records before he formed an opinion on Don Schell. He said 14:11:30 3 that statistical significance is not an important term in 14:11:34 4 terms of causation, that it can be used whether -- data can 14:11:38 5 be used whether or not there is statistical significance, 14:11:40 6 which is something that Dr. Wang, the only epidemiologist 14:11:44 7 here, indicated you simply cannot do. 14:11:48 8 He had no data on Paxil, as we just discussed, so he 14:11:52 9 talked about Prozac. He dismissed the fact that Don Schell's 14:11:57 10 inability to work was of any significance in his opinion, and 14:12:01 11 I think you need to ask yourselves whether Dr. Healy says 14:12:07 12 what he needs to say to get out of a particular situation. 14:12:10 13 Is he telling us something different in this courtroom than 14:12:13 14 he would tell scientists in a peer-reviewed article? 14:12:17 15 Now, Dr. Maltsberger has very, very limited 14:12:20 16 experience with SSRIs, and Paxil in particular. In his 14:12:25 17 entire life, two cases, two patients have received Paxil. He 14:12:29 18 also did not read the entire literature that -- and medical 14:12:35 19 records that pertained to Don Schell. Nor was he familiar 14:12:39 20 with the scientific data that was available from the outside, 14:12:44 21 and because of that lack of familiarity with it suggested a 14:12:48 22 labeling that could not be backed up by science; i.e., 14:12:52 23 there's nothing that shows that Paxil commits -- causes 14:12:56 24 somebody to commit suicide or homicide and yet that was 14:13:00 25 something he advocated. 55 14:13:01 1 The result of that would be a label which would scare 14:13:04 2 patients from seeing doctors, scare doctors from prescribing 14:13:08 3 and patients who received prescriptions from taking it as 14:13:13 4 directed. That would not be an advantage to the mental 14:13:17 5 health in this country or anybody with depression. 14:13:19 6 He did acknowledge that the patient information 14:13:21 7 booklet that was available from SmithKline discussing 14:13:27 8 depression was most appropriate in helping patients that 14:13:30 9 might have suicidal thoughts, telling them that they should 14:13:34 10 see their doctor promptly. 14:13:41 11 Dr. Marks, he's the expert that was retained through 14:13:44 12 the Internet. He said what he was asked to say, but he had 14:13:51 13 nothing to back it up. He said that we didn't test enough. 14:13:56 14 He hadn't read any of the articles that discussed our data. 14:13:59 15 He hadn't looked at any of the data from the company. He 14:14:03 16 just said that we need to warn differently. He said he based 14:14:09 17 that on the aggression report. 14:14:12 18 The aggression report -- you recall we talked quite a 14:14:18 19 bit about the aggression report with him, and that aggression 14:14:21 20 report established that Paxil does not cause aggression and 14:14:33 21 he conceded that indeed one could not rely on case reports to 14:14:40 22 form causation opinions in general. 14:14:47 23 He then talked about underreporting on the data, but 14:14:52 24 the data is all there. That data was submitted to the FDA in 14:14:57 25 the year 2000, so they have our aggression data, and even 56 14:15:02 1 though there may be underreporting, as Dr. Mann told us, if 14:15:06 2 you're talking about something like suicide or homicide, that 14:15:09 3 is something that is extremely unlikely it would not be 14:15:12 4 reported. 14:15:13 5 So what we have is we have scientists turned 14:15:17 6 advocates and they've offered us no scientific evidence 14:15:21 7 whatsoever to support the claim that Paxil causes suicide or 14:15:25 8 homicide in any population group whatsoever. 14:15:30 9 Now, I would like to talk about what I would call 14:15:34 10 misleads, a small item but symbolic. Initially we heard that 14:15:41 11 SSRI was a term that was coined by SmithKline. Simply not 14:15:46 12 true. Dr. Mann and Dr. Wheadon said that term was well in 14:15:49 13 use before Paxil ever was available to physicians in January 14:15:53 14 of 1993. 14:15:55 15 Discussion about prospective studies on Paxil, we 14:16:01 16 heard a lot about that today. Every one of those clinical 14:16:05 17 trials is a prospective randomized trial, the best that you 14:16:10 18 can get to get the data. That's what Dr. Wang told us, 14:16:14 19 randomized clinical control trials. 14:16:17 20 Those studies all establish that there is no 14:16:19 21 subpopulation. So I hesitate to wonder why we were getting 14:16:29 22 that question, because there are studies that have been done, 14:16:32 23 have been approved by the FDA, looked at by independent 14:16:37 24 experts, our database has been analyzed thoroughly every 14:16:41 25 which way and our prospective studies come up with the same 57 14:16:45 1 answer. The plaintiffs just don't want to believe those 14:16:50 2 answers. 14:16:50 3 The par 57 studies, Verkes was a publication that 14:16:54 4 looked at suicide risk, patients with suicidal attempts in 14:16:59 5 the past. And they were looked at to see if they were more 14:17:04 6 likely to have earlier ones. And once again, Paxil proved to 14:17:10 7 help in that situation, subpopulation. 14:17:13 8 Now, this whole business of a subpopulation was dealt 14:17:19 9 with in the studies and it keeps coming up again. Remember, 14:17:22 10 that was raised in the 1990, 1992 time frame before Paxil was 14:17:27 11 even available to physicians and the case has been tried as 14:17:31 12 if the plaintiffs would stop time in 1992. They've ignored 14:17:35 13 the studies that have been discussed by Dr. Mann and 14:17:38 14 Dr. Wang. 14:17:40 15 We have heard about alcohol. We have heard about 14:17:43 16 allergy. As recently as this morning we heard about LSD. 14:17:47 17 Dr. Mann told us how misleading was his term to try to 14:17:52 18 compare LSD to Paxil. We're here to learn about Paxil. If 14:17:58 19 you want to know about Paxil, you have to look at Paxil. 14:18:01 20 The German label. I don't know why we've heard about 14:18:13 21 the German label, but I will read you the English 14:18:16 22 translation. It is "Paroxetine does not generally have a 14:18:19 23 sedative effect. Occasionally in patients with acute 14:18:22 24 suicidal tendencies and in patients who suffer from marked 14:18:29 25 restlessness and insomnia, adjutant sedative therapy may be 58 14:18:33 1 necessary." 14:18:35 2 Germany has a different regulatory body. Their 14:18:39 3 clinicians certainly practice medicine but they have their 14:18:44 4 own techniques. We both know Don Schell was not acutely 14:18:49 5 suicidal when he saw Dr. Patel. He didn't have marked 14:18:52 6 restlessness, but he did have insomnia and was given Ambien. 14:19:12 7 I'm not sure why we're talking about the German label. 14:19:16 8 Akathisia, we've heard a lot about akathisia. 14:19:18 9 There's no evidence of akathisia in this case. Dr. Suhany, 14:19:21 10 Dr. Hemphill were both asked, "Did he have akathisia?" And 14:19:26 11 the answer was no. No indication that Don Schell had 14:19:29 12 akathisia when he saw Dr. Patel. Not mentioned at all. 14:19:32 13 I'm not sure why we're talking about akathisia, but 14:19:35 14 remember, the issue is whether akathisia, if it were there, 14:19:38 15 which it is not in Don Schell's case, can cause murder or 14:19:41 16 suicide. Is it a step that leads to that? 14:19:46 17 So you get to the bottom line question, does Paxil 14:19:49 18 cause suicide, homicide, suicidal thoughts, homicidal 14:19:53 19 thoughts, et cetera. And the answer is no. One, two, three, 14:19:58 20 four, five, six studies. 14:20:06 21 All right. Let's talk about this Exhibit 12 here. 14:20:33 22 What this is is a clinical study. This is a clinical trial, 14:20:46 23 one of the trials reported in there and this is reported in 14:20:50 24 here. Everything that happens is reported in here. 14:21:01 25 This column here is the clinical investigator here is 59 14:21:03 1 making an evaluation of this particular patient with regard 14:21:06 2 to attempted suicide and concludes that very probably it is 14:21:10 3 related to the medication which in this case is Paxil. You 14:21:19 4 can't see that, but that's what it is. 14:21:22 5 You go down here, and much was made of that, and down 14:21:25 6 here you have suicidal ideation. You also have a 5. I want 14:21:30 7 to go over to the far left, if you can, please. You see, 14:21:34 8 that's a placebo. You remember what a placebo is, it is a 14:21:40 9 sugar pill. Now, it is a double-blind study, right? That 14:21:44 10 means the doctor doesn't know what the patient is getting. 14:21:47 11 The patient doesn't know what they're getting. Some gets 14:21:51 12 placebo, some a comparator drug and some get Paxil. 14:21:55 13 The one on the top, they got Paxil. The clinical 14:21:58 14 investigator found out or had the belief that it was very 14:22:02 15 probably related. 14:22:03 16 Well, on the placebo one on the bottom, 5 as well. 14:22:09 17 We know a placebo can't cause it. The point is that that 14:22:14 18 data is all sent to the FDA. It is available to everyone and 14:22:19 19 has been available to everybody that did a study on it. It 14:22:23 20 is reporting all of the information on it. 14:22:25 21 But the key issue is among the three groups -- the 14:22:29 22 placebo, Paxil and the comparator drug -- is there any 14:22:34 23 increased risk of suicide or homicide? And indeed this 14:22:39 24 particular study was discussed in the ACNP statement and 14:22:44 25 Dr. Mann talked about that. The number of patients was 2963, 60 14:22:52 1 and indeed, with respect to Paxil, Paxil was below both 14:22:57 2 placebo -- below both placebo and the comparator drug with 14:22:58 3 respect to suicide attempts and suicides. 14:23:06 4 So the bottom line is this study, all of this data is 14:23:10 5 very important, available to anybody, but the point is you 14:23:13 6 don't always know -- you have, I'm sure, a conscientious 14:23:17 7 clinical investigator that says a placebo caused suicidal 14:23:22 8 ideation. 14:23:22 9 Well, we know that can't be, and it means that it is 14:23:26 10 a clinical judgment, and the way you test it is a 14:23:30 11 double-blind control study, which is exactly what was done 14:23:35 12 there and reanalyzed on numerous occasions over here. 14:23:55 13 Also in the same vein there was a discussion about 14:23:58 14 the percentage figure being rounded off to zero and 14:24:03 15 hallucinations, eight. Dr. Wang was questioned about this. 14:24:08 16 All of that data goes down to the FDA. It is all considered. 14:24:11 17 It goes into the labeling issue. It is approved by the FDA. 14:24:16 18 That data is available to everybody. Those eight 14:24:20 19 hallucinations cases did not disappear. They're still there. 14:24:23 20 They're still in the data. It is all in the data. Anybody 14:24:24 21 that needs to know has the data right there. 14:24:42 22 I think as to the publication of the clinical data, 14:24:43 23 Dr. Healy they said this morning said that was not available 14:24:47 24 to the FDA. That material was all published. No question 14:24:50 25 about it. Some investigators choose to publish it, some say 61 14:24:54 1 come and get the data and some get it from us, some go to the 14:24:57 2 FDA and get our permission for the FDA and publish it, but 14:24:58 3 there's no secret with our data. It is available to anybody 14:25:02 4 that wants to look at it. It is available to the FDA. They 14:25:05 5 can look at it and make any request, as they have on 14:25:08 6 suicidality in 1991, and later on to request our data for 14:25:12 7 that. 14:25:13 8 The use of the Ham D questionnaire in our clinical 14:25:17 9 trials was criticized. Dr. Mann discussed that. Dr. Wheadon 14:25:22 10 discussed that. Dr. Wang discussed that. The Ham D is 14:25:27 11 perfectly adequate to get what you need to get and that is do 14:25:33 12 you have reports of suicide attempts, homicide attempts, 14:25:36 13 suicidal ideation, homicidal ideation? Do you have that? 14:25:41 14 That data is easily pulled out. It is pulled out from the 14:25:45 15 data and can be reported just as we saw on that slip. It is 14:25:48 16 right there. 14:25:52 17 Titration, something was made of that. Tim Haase, 14:25:58 18 actually the first witness in the case, you might remember, 14:26:01 19 right after opening statements was questioned about the 14:26:07 20 titration, and you start them out on a half dose. 14:26:10 21 The whole discussion on titration revolved around 14:26:14 22 panic disorder, and panic disorder is different from 14:26:17 23 depression. And indeed, if you take a look at the PDR, the 14:26:23 24 Physician's Desk Reference, what the doctor gets with the 14:26:25 25 medication, says you start out for panic disorder at 10 62 14:26:30 1 milligrams, which is half the dose for depression. And then 14:26:34 2 you change it if you want as determined as you go along. 14:26:40 3 The same titration is used for depression as the 14:26:48 4 starting dose, as Dr. Mann indicated and Dr. Merrell 14:26:53 5 indicated, the same use is appropriate is the 20. So I'm not 14:27:06 6 sure why we're talking about titration. 14:27:08 7 Multi-factorial enters into whether we're taking a 14:27:13 8 look at a murder/suicide or a suicide/homicide. Our position 14:27:18 9 is Paxil is not one of the factors at all based on the 14:27:22 10 science. 14:27:23 11 Now let's turn our attention to the SmithKline 14:27:26 12 experts. They stayed within their specialties. They relied 14:27:31 13 on outside data. Dr. Wang, the only epidemiologist, first 14:27:36 14 time in a courtroom setting, we discussed what he's shown. 14:27:40 15 Dr. Tardiff, he's an expert on murder/suicides, a 14:27:46 16 thousand a year. Really kind of an incredible thing when you 14:27:49 17 stop and think about it. A lot in my view. 129 in New York 14:27:54 18 City for eight years he's looked at. None had Paxil. One 14:28:02 19 had an antidepressant but happened to be on heroin as well. 14:28:06 20 The interesting thing about his testimony was the 14:28:08 21 analysis of the types of murder/suicide, how people fit into 14:28:20 22 certain groups. And he went through the groups as spouse 14:28:29 23 jealousy, the killing of children, declining health in 14:28:34 24 spouses, and lastly, the family murder/suicide where you have 14:28:39 25 a senior male, depressed, social stressors, financial 63 14:28:44 1 concerns, job concerns, personalities that might be 14:28:51 2 controlling or possessive, and that's where he put Don 14:28:55 3 Schell. 14:28:57 4 Dr. Mann, acknowledged world-class, by plaintiffs, 14:29:09 5 suicidologist. I think if you listened to him and saw him, 14:29:09 6 he's a man dedicated to what he does, extremely intelligent 14:29:15 7 individual. And the simple reason he hasn't published since 14:29:19 8 1992 on this issue is because the questions he asked as an 14:29:23 9 advisor to the FDA advisory committee, as head of the task 14:29:27 10 force for the ACNP, and as an author of the Mann-Kapur 14:29:31 11 article is that the answer is in. 14:29:34 12 He talked about the studies of Dr. Wang, talked about 14:29:41 13 the studies himself, and the opinion he held in 1990, 1991, 14:29:44 14 1992 when he asked the question saying, "It is my view there 14:29:49 15 isn't a risk of suicide and homicide with any SSRI." And he 14:29:54 16 said, looking at the data, "Since that I still believe that." 14:30:00 17 We have all that data from 1992 forward that reinforces that 14:30:04 18 opinion. 14:30:05 19 Dr. Merrell, he really did -- and I think we 14:30:07 20 discussed in the opening, I knew that he would have the most 14:30:10 21 thorough view of Don Schell's history. And if you're going 14:30:18 22 to comment on what Don Schell died from and what happened 14:30:21 23 before he died, you really need to understand that. 14:30:23 24 And Dr. Merrell showed why he is a very important 14:30:26 25 psychiatrist for the state of Wyoming, a clinician that I 64 14:30:39 1 think nobody can dispute is very, very caring about his 14:30:42 2 patients and wants to make sure that he helps them succeed in 14:30:45 3 coming out of their depression. 14:30:48 4 And he told us that Don Schell was undertreated and 14:30:50 5 essentially untreated and that Paxil was a red herring and 14:31:00 6 that depression unfortunately overcame. 14:31:08 7 Let's take a look now at Don Schell's history of 14:31:10 8 depression. And I know you went over that yesterday so I'm 14:31:12 9 not going to spend a lot of time. But I think it is 14:31:15 10 important to realize when you listen to Dr. Merrell's 14:31:19 11 testimony as he goes through that, when you have a depressive 14:31:21 12 episode and you don't get up to par and you don't stay there, 14:31:28 13 and you have a second one, you keep stacking the deck against 14:31:33 14 yourself. Each time it gets worse and worse and worse, and 14:31:36 15 your chance of having a succeeding one increases every time 14:31:39 16 that you get the past one. 14:31:41 17 So that he was at a 95 percent risk of, I think, 3 or 14:31:48 18 4. I don't remember precisely Dr. Merrell's testimony. And 14:31:52 19 he emphasized the importance and I think illustrated through 14:31:56 20 Dr. Suhany's records on the importance of continuing 14:31:59 21 treatment, continuing medication, and how it takes time to 14:32:02 22 get you to a level that you want to be, to maintain that 14:32:05 23 level and the importance of continuing that thereafter. 14:32:14 24 So we had 1994 -- 1984, '89, '90, '91 and '93, five 14:32:23 25 depressive episodes. And to call those garden variety 65 14:32:27 1 depressions or mild depressions when somebody who depended as 14:32:30 2 much on work for his feeling of self-confidence and 14:32:35 3 self-worth, those were serious depressions, and each time he 14:32:41 4 was out of work. And that was the most troublesome to him in 14:32:47 5 February of 1998. 14:32:48 6 And again, as we discussed earlier, Don Schell was 14:32:56 7 unfortunately -- did not like to talk about his depression, 14:33:00 8 did not want to share it. Tim Tobin knew about three 14:33:04 9 episodes. Neva Hardy heard about a couple. Even Peggy Deans 14:33:11 10 who herself has been treated with Prozac very successfully 14:33:15 11 and very happi