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. May 21, 2001 9 Excerpt of Volume I SMITHKLINE BEECHAM PHARMACEUTICALS, 10 Defendant. 11 ----------------------------------------------------------- 12 EXCERPTED TRANSCRIPT OF TRIAL PROCEEDINGS 13 OPENING STATEMENTS 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 22 Court Reporter: Ms. Janet Dew-Harris, RPR, FCRR Official Court Reporter 23 2120 Capitol Avenue Room 2228 24 Cheyenne, Wyoming 82001 (307) 635-3884 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 OPENING STATEMENTS PAGE 21 By Mr. Vickery 3 By Mr. Pruess 32 22 23 24 25 3 1 P R O C E E D I N G S 2 (Trial proceedings commenced 3 8:30 a.m., May 21, 2001.) 4 (Motions in limine and jury selection not transcribed.) 5 6 * * * * * * * * * * 7 14:16:44 8 THE COURT: We will proceed with the opening 14:16:44 9 statements, and Mr. Vickery, you may proceed. 14:16:44 10 MR. VICKERY: Thank you, Your Honor. May it please 14:16:44 11 the Court, ladies and gentlemen of the jury, again, my name 14:16:44 12 is Andy Vickery and this is the only time until the end of 14:16:44 13 the case that I can speak to you directly, even in the hall. 14:16:58 14 The most we can do is kind of nod our heads to one another, 14:16:58 15 and that's the way the process is supposed to be. His Honor 14:16:58 16 has given me an hour and given the other side an hour to sort 14:16:58 17 of give you a road map, if you will, to give an opening 14:16:58 18 statement in the case. 14:16:58 19 I've been doing this about 28 years and really am a 14:16:58 20 paper and pad kind of guy, but courtesy of all of this I'm 14:16:58 21 going to try something I haven't. So we'll see if I can mess 14:16:58 22 it up or not. 14:16:58 23 This is a case, ladies and gentlemen, it is the case 14:16:58 24 of Tobin and Schell versus SmithKline Beecham 14:16:58 25 Pharmaceuticals. It is a case in which we seek justice for 4 14:16:58 1 the wrongful deaths of four innocent people. 14:16:58 2 Now, in this case you're going to learn a lot of new 14:16:58 3 things. And you're going to learn specifically about SSRI 14:16:58 4 drugs and suicide. 14:16:58 5 Can everyone see that okay? 14:16:58 6 It is not my purpose nor would it be proper for me to 14:16:58 7 argue the evidence now or the law. All the law that we will 14:16:58 8 need for this case, as Mr. Gorman told you, will come from 14:16:58 9 His Honor, Judge Beaman at the end. And at the end it may be 14:16:58 10 proper for Mr. Fitzgerald and I to suggest to you inferences 14:16:58 11 from the evidence. That's not what we're here to do right 14:16:58 12 now. 14:16:58 13 Right now we're here to outline for you what kinds of 14:16:58 14 evidence you will hear on what issues and what it will tend 14:16:58 15 to show and some things that might help you as you look at 14:16:58 16 that evidence and assess that evidence to do what you 14:16:58 17 ultimately have to do at the end of the case and that is to 14:16:58 18 render a verdict that will result in justice in this case. 14:16:58 19 You're going to learn a lot about SSRI drugs and 14:16:58 20 suicide and we're going to put on evidence to prove two 14:16:58 21 things to you. 14:16:58 22 Since at least early 1990, SmithKline Beecham has 14:16:58 23 known that SSRI drugs like Paxil pose a serious risk of 14:16:58 24 violence and suicide for a small vulnerable subpopulation of 14:16:58 25 patients; not all of the patients, not even the majority of 5 14:16:58 1 patients, but for a small vulnerable subpopulation. 14:16:58 2 SSRI stands for selective serotonin reuptake 14:16:58 3 inhibitor, and it refers to a class of drugs that includes 14:16:58 4 Prozac, Zoloft and Paxil, a couple others, actually, in 14:17:14 5 addition. 14:17:14 6 The second thing we're going to show you is that Don 14:17:14 7 Schell was one of those vulnerable people. 14:17:14 8 Now, come with me, if you will, from Wyoming to 14:17:14 9 Philadelphia, Pennsylvania in the time period from 1988 to 14:17:14 10 1993. As Mr. Gorman told you, Philadelphia is the operations 14:17:14 11 center for SmithKline Beecham. Its headquarters are over in 14:17:14 12 the United Kingdom but Philadelphia is the operations center 14:17:14 13 in this country. 14:17:14 14 And let's look at some of the significant events that 14:17:14 15 happened in each of those years. 14:17:14 16 In 1988 you will hear evidence that Prozac was 14:17:14 17 launched in the market in this country by Eli Lilly & 14:17:14 18 Company. It became the largest selling antidepressant drug 14:17:14 19 in the history of mankind. And up in Philadelphia, of 14:17:14 20 course, they didn't have anything to compete with that drug. 14:17:14 21 So in that year SmithKline Beecham patented -- got a 14:17:14 22 patent from the United States Patent Office for a chemical 14:17:14 23 substance called paroxetine. Later they adopted the trade 14:17:14 24 name Paxil, P A X I L, for paroxetine, and you will hear us 14:17:14 25 use those words interchangeably throughout the trial. 6 14:17:14 1 The following year SmithKline Beecham finalized a new 14:17:14 2 drug application with the Food & Drug Administration and 14:17:14 3 submitted all of this data to them and said, "We want to 14:17:14 4 market our drug in competition with another SSRI drug, 14:17:14 5 Prozac. We've tested it in some patients. We've done some 14:17:14 6 clinical trials and here is our data." 14:17:14 7 Let me tell you what you will see from that 14:17:14 8 information. 21 percent of the patients who volunteered to 14:17:14 9 participate in those clinical studies dropped out because of 14:17:14 10 adverse side effects, mainly in the first week or two. I 14:17:14 11 think that you will find this important and significant as 14:17:14 12 you consider the fact that Mr. Schell had only been on this 14:17:14 13 medicine for a couple of days. The adverse effects were 14:17:14 14 mainly in the early period. 14:17:14 15 And the following adverse experiences according to 14:17:14 16 their own documents were either definitely caused by Paxil or 14:17:14 17 possibly caused by Paxil within the first week or two. 14:17:14 18 Akathisia and an overactive brain: You will learn 14:17:14 19 about this term "akathisia." It refers to -- I guess the 14:17:14 20 best lay word is turmoil, a sense of incredible inner 14:17:14 21 turmoil. Sometimes you see laypeople describe it as like 14:17:14 22 they had ants in their pants or they wanted to jump out of 14:17:27 23 their skin, something like that. Sometimes it was 14:17:27 24 accompanied by outward motor movements, jitteriness, tapping 14:17:27 25 of the feet, movement of the hands, that type of thing. 7 14:17:27 1 Mania, hypomania: Mania would be someone who is 14:17:27 2 almost feverish, who was just bouncing off the walls, 14:17:27 3 climbing the walls, frequently accompanied by irritability or 14:17:27 4 aggression towards other people. 14:17:27 5 Psychosis, we've all heard that term, same root 14:17:27 6 word -- just as mania is the root word of maniac, psychosis 14:17:27 7 is of psychotic, being out of touch completely with reality. 14:17:27 8 These are the people that don't know right from wrong. 14:17:27 9 Attempted suicides: You will see those documented as 14:17:27 10 either definitely or possibly caused by Paxil. 14:17:27 11 Hostility and aggression, abnormal dreams and 14:17:27 12 nightmares: Now, I believe as you consider all of the 14:17:27 13 evidence in the case, you will find that significant because 14:17:27 14 the defendants -- the coroner could tell the deaths happened 14:17:27 15 in the wee hours of the morning and the family were clad in 14:17:27 16 their pajamas. 14:17:27 17 Insomnia, depersonalization, or as one person 14:17:27 18 described it, feeling zombie-like: That was documented. 14:17:27 19 Depersonalization is one of those out-of-body 14:17:27 20 experiences, you know. 14:17:27 21 And hallucinations, seeing things that aren't there. 14:17:27 22 The following year in 1990 something very significant 14:17:27 23 happened in February. An article was published in the 14:17:27 24 scientific literature by two very prominent Harvard 14:17:27 25 psychiatrists and psychopharmacologists. Those are people 8 14:17:27 1 that know about mind-altering drugs. 14:17:27 2 And these two Harvard physicians wrote a paper in a 14:17:27 3 prominent peer-reviewed journal saying, "We've just 14:17:27 4 discovered that a small percentage of patients seem to have a 14:17:27 5 real problem with violent suicidal thinking or 14:17:27 6 de novo suicidal thinking." They estimated this is 3 and a 14:17:27 7 half to 5 percent of the patients. 14:17:27 8 And they were talking about Prozac. That was the 14:17:27 9 only drug on the market at that time. It was the only SSRI 14:17:27 10 drug on the market. When they wrote that, it caused quite a 14:17:27 11 stir. 14:17:27 12 And in October of that year, the Food & Drug 14:17:27 13 Administration asked these folks, SmithKline Beecham, to, 14:17:43 14 quote, "Submit a detailed response to the public's concern 14:17:43 15 discussing violence and suicide," with respect to Paxil. 14:17:43 16 "Since it is an SSRI drug," they said, "does it have a 14:17:43 17 similar problem?" And you will see the October 3rd, 1990 14:17:43 18 conversation record. 14:17:43 19 In the next year, 1991, a very important article was 14:17:43 20 published. The scientific community had for about a year and 14:17:43 21 a half been thinking about, writing about this issue of SSRI 14:17:43 22 drugs, mainly Prozac because it was the only one on the 14:17:43 23 market, and violence or suicide. 14:17:43 24 And Drs. Mann and Kapur wrote an article in 14:17:43 25 September. Now, this is very important for a couple of 9 14:17:43 1 reasons. One of these gentlemen you will hear from, 14:17:43 2 Dr. J. John Mann, knows a lot about suicidology and 14:17:43 3 psychopharmacology and he's been hired as an expert by 14:17:43 4 SmithKline Beecham. He will testify. 14:17:43 5 In this article that he wrote for his peers in 1991, 14:17:43 6 he wrote that although the drug -- there's no evidence to 14:17:43 7 prove the drug was a problem for most people, that it was 14:17:43 8 entirely possible that there was a small vulnerable 14:17:43 9 subpopulation of patients at risk for violence or suicide as 14:17:43 10 a result of taking this drug. 14:17:43 11 And he made two specific recommendations. He 14:17:43 12 recommended specific testing, and he recommended immediate 14:17:43 13 warnings. In fact, not only did he just say, "You should 14:17:43 14 test," but when you see his article and when we discuss it 14:17:43 15 with him and other witnesses, you will see that he detailed 14:17:43 16 not one but two, three, four different ways that the drug 14:17:43 17 company could test for this to find out, hey, is this really 14:17:43 18 a problem, and if so, how bad? 14:17:43 19 In November of that year an article was written by 14:17:43 20 Dr. Healy and Mr. Creaney. I've misspelled his name. 14:17:43 21 Dr. Healy is in the United Kingdom where SmithKline Beecham 14:17:43 22 is headquartered and he is a leading authority on 14:17:43 23 neuropsychopharmacology. He's this gentleman sitting over 14:17:43 24 here with his hand up by his mouth. He is our expert and he 14:17:43 25 will be testifying tomorrow. He's written the only 10 14:17:43 1 definitive book that's a history of the antidepressant era 14:17:43 2 called The Antidepressant Era and published a couple years 14:17:43 3 ago by the Harvard Press. 14:17:43 4 And Dr. Healy, this was the first time in the 14:17:57 5 published, peer-reviewed literature where he said, "Hey, 14:17:57 6 there may be a problem with these SSRI drugs." He was 14:17:57 7 talking about two of them, one being Prozac, fluoxetine, and 14:17:57 8 paroxetine, Paxil, which was being used in Europe but not in 14:17:57 9 this country at that time. 14:17:57 10 The following year, 1992, three things happened of 14:17:57 11 significance. First, SmithKline Beecham hired Dr. David 14:17:57 12 Wheadon, and that becomes very significant for reasons I'll 14:17:57 13 explain to you in a minute. 14:17:57 14 Second, in March of that year there was a consensus 14:17:57 15 paper published by a very prestigious organization, the 14:17:57 16 American College of Neuropsychopharmacologists, or ACNP. 14:17:57 17 The principal author of that paper was SmithKline's 14:17:57 18 expert, Dr. J. John Mann. And in that paper he talked about 14:17:57 19 the akathisia. Remember, we've seen it was documented as 14:17:57 20 being caused by Paxil. And he wrote that akathisia side 14:17:57 21 effects may aggravate or provoke aggression or suicidality 14:17:57 22 and recommended that patients should be warned. 14:17:57 23 On December 30th, 1992, the Food & Drug 14:17:57 24 Administration approved Paxil to be sold in competition with 14:17:57 25 Prozac as an antidepressant in this country. Thus, it was 11 14:17:57 1 launched the following year. But I promised you I would tell 14:17:57 2 you about Dr. Wheadon and here's what I'm going to tell you 14:17:57 3 about. 14:17:57 4 It relates to SmithKline Beecham's knowledge about 14:17:57 5 this small vulnerable subpopulation. You see, Dr. Wheadon 14:17:57 6 came over from Eli Lilly. He worked for Eli Lilly from 1987 14:17:57 7 until 1992, and they're the maker of Prozac. And he dealt a 14:17:57 8 lot with this very issue. 14:17:57 9 You remember me talking about that Teicher and Cole 14:17:57 10 article that started it all in February of '90? When that 14:17:57 11 article came out, Dr. Wheadon as an employee for Eli Lilly 14:17:57 12 flew to Boston twice to meet with Dr. Teicher to discuss the 14:17:57 13 issue of SSRI-induced suicide with him and how they could 14:17:57 14 study and get their arms around the issue. 14:17:57 15 He also went to Europe and met with seven different 14:17:57 16 international consultants in Europe, and they concluded that 14:17:57 17 the most definitive assessment of a potential relationship 14:17:57 18 between fluoxetine, and that's the name for Prozac, and 14:17:57 19 suicidal ideation or behavior would be some sort of 14:17:57 20 prospective study. 14:18:13 21 Put that word in green because that's going to be 14:18:13 22 important for you as you consider the evidence and you hear 14:18:13 23 about all of the studies and as we have a great debate in 14:18:13 24 this courtroom for the next two weeks about science and what 14:18:13 25 constitutes science. 12 14:18:13 1 You need to bear in mind that Dr. Wheadon was told it 14:18:13 2 needed to be looked at prospectively: Design the study to 14:18:13 3 figure out if it causes suicide and then conduct the study as 14:18:13 4 opposed to looking at studies performed for another purpose 14:18:13 5 to see if they tell you something about another issue. 14:18:13 6 Indeed, while he was an employee at Eli Lilly, 14:18:13 7 Dr. Wheadon, along with about a hundred other people, helped 14:18:13 8 Dr. Charles Beasley design just such a study, a way to study 14:18:13 9 this issue. It is called a rechallenge study. And he 14:18:13 10 participated in a meeting where Eli Lilly met with the FDA 14:18:13 11 and promised to do that study. They never did, nor has 14:18:13 12 SmithKline Beecham. 14:18:13 13 We were up to '92. In February of 1993 Paxil was 14:18:13 14 indeed launched in this country. Let's look at the next 14:18:13 15 five-year period briefly. We're still in Philadelphia. I 14:18:13 16 promise to get you to Wyoming before I'm done. 14:18:13 17 In the next five years there were two sources of 14:18:13 18 continuing information about the small vulnerable 14:18:13 19 subpopulation of patients who were potentially at risk 14:18:13 20 because of these drugs. 14:18:13 21 One was more scientific literature and the second was 14:18:13 22 reported adverse events. Let's look briefly at each of 14:18:13 23 those. 14:18:13 24 Scientific literature: There were many other 14:18:13 25 articles, and in my opening statement I couldn't possibly 13 14:18:13 1 plunk down all of them for you. This one I've listed is very 14:18:13 2 important. It happened six months before the tragedy that 14:18:13 3 brings us all here today, so it was fairly current. It was 14:18:13 4 written by someone who worked for another SSRI manufacturer. 14:18:13 5 Dr. Roger Lane at Pfizer wrote this article and he was 14:18:13 6 surveying and reviewing all the scientific literature to 14:18:13 7 figure out do SSRI drugs really cause akathisia. 14:18:13 8 And he reviewed about 50 articles about these drugs 14:18:13 9 as a class, 11 of them which were specific to Paxil. He 14:18:13 10 concludes that SSRIs do indeed cause akathisia and that 14:18:13 11 akathisia increases the risk of violence and of suicide. 14:18:26 12 Meanwhile, as they expanded from the hundreds of 14:18:26 13 patients who were in clinical trials to the millions of 14:18:26 14 patients who took the drug once it is marketed, over the 14:18:26 15 five-year period they had adverse events reported. And I 14:18:26 16 believe you will see evidence to indicate that there were 14:18:26 17 regularly recurring suicides in which the treating doctors 14:18:26 18 considered Paxil as suspect. And there were regularly 14:18:26 19 recurring reports of suicidal ideation, aggression, akathisia 14:18:26 20 and agitation, all of which are warning signs of suicide and 14:18:26 21 violence. 14:18:26 22 Let's come to Wyoming. Gillette, Wyoming, 1990 to 14:18:26 23 1998. Don and Rita Schell married in 1961. I wrote the 14:18:26 24 family tree up here for you. Flo and Gerald Reavis had three 14:18:26 25 daughters; Peggy, Neva who is sitting right here, and her 14 14:18:26 1 sister Rita. 14:18:26 2 Rita and Don married in 1961. They had two children, 14:18:26 3 Michael Schell and Debra. Debra married Tim Tobin in 1992, 14:18:26 4 and in May of 1997 their baby, Alyssa, was born. We have Tim 14:18:26 5 and Debbie getting married and Alyssa born in 1997. 14:18:26 6 Ladies and gentlemen, I would like for you to meet 14:18:26 7 Don and Rita Schell. You will get to know them over the 14:18:26 8 course of the next two or three weeks from the memories of 14:18:26 9 the people that knew them best, their friends and families. 14:18:26 10 I think you will learn that Don Schell liked to put 14:18:26 11 his arm around his wife. And believe it not, somebody may 14:18:26 12 criticize that, but he liked to do that. He liked to hold 14:18:26 13 her hand. They held hands most places they went. He liked 14:18:26 14 to walk with her in the afternoon and she liked to leave her 14:18:26 15 part-time job at the real estate place to be home and walk 14:18:26 16 with her husband in the afternoon. You will not hear any 14:18:26 17 witness sit in that chair and say that this man ever raised a 14:18:26 18 hand in anger to his wife in 37 years of marriage. 14:18:26 19 1992 is their wedding day and here is Don with his 14:18:26 20 daughter on the day that he gave her away to Tim. I wasn't 14:18:26 21 quite sure what they were doing. My own daughter is getting 14:18:26 22 married in November of this year, but I've learned that this 14:18:26 23 is the garter ceremony. The father of the bride puts the 14:18:26 24 garter on and I understand the husband, the groom, takes it 14:18:43 25 off. 15 14:18:43 1 Five years later Tim and Debbie presented Don and 14:18:43 2 Rita with a little baby, Alyssa, and you will find that she 14:18:43 3 was the apple in her granddaddy's eye. He loved that baby. 14:18:43 4 Now, you've heard references to evidence about Don 14:18:43 5 Schell and depression, and I just want to tell you there will 14:18:43 6 be disputes about the extent of the problems he had with 14:18:43 7 depression. There are certainly episodes of depression, 14:18:43 8 usually triggered by something like worry over his job when 14:18:43 9 Cities Service, his employer, was consolidating or leaving 14:18:43 10 the oil fields. 14:18:43 11 But there's no question about it in 1992 he was 14:18:43 12 treated throughout that year by a very competent 14:18:43 13 psychiatrist, Dr. Suhany. Dr. Suhany did not just see him in 14:18:43 14 the office 15 minutes and give him a pill. He saw him 18 to 14:18:43 15 21 times for an hour a time and gave him a lot of 14:18:43 16 psychotherapy, talking therapy, got to know him, get inside 14:18:43 17 his head, figure out what makes him tick. 14:18:43 18 And Dr. Suhany, because Don came there with 14:18:43 19 depression, inquired very carefully whether he was a risk to 14:18:43 20 himself or anyone else. You will see from his records and 14:18:43 21 his testimony that he found that he was not a violent man, he 14:18:43 22 had no suicidal thoughts or tendency. He thought about death 14:18:43 23 but nothing suicidal, no family problems at all. 14:18:43 24 Unfortunately, this relates to just how and in what 14:18:43 25 sequence you will see the evidence. A lot of it is 16 14:18:43 1 controlled by factors beyond our control like people's 14:18:43 2 availability. Dr. Suhany unfortunately can't be here until 14:18:43 3 later in the trial, so -- I would that you could hear him 14:18:43 4 early on because he's a very important witness. 14:18:43 5 Guess what? Dr. Suhany tried him in January of 1990 14:18:43 6 on one of the new classes of drugs, the SSRI drugs, 14:18:43 7 specifically Prozac, and Mr. Schell didn't react very well to 14:18:43 8 that. 14:18:43 9 Even though he was given another drug which is an 14:18:43 10 antidote, benzodiazepine, to take the edge off, even though 14:18:43 11 he was on that, he was still jittery, he was anxious and then 14:18:43 12 he developed tremors. 14:18:43 13 Dr. Suhany gave him another antidote to counteract 14:18:43 14 the tremors and a week later decided, "This kind of drug 14:18:59 15 doesn't work for you. I'm going to wean you off of it." 14:18:59 16 And he did and treated him throughout the rest of the 14:18:59 17 year with a completely different kind of medication plus 14:18:59 18 psychotherapy, and he found that Don did real well. 14:18:59 19 And you will also hear his testimony that Don wanted 14:18:59 20 to do real well. He was what doctors called a compliant 14:18:59 21 patient. He had a good therapeutic alliance with his doctor. 14:18:59 22 He wanted the doctor's help and he followed the doctor's 14:18:59 23 orders. 14:18:59 24 You will see records from a couple doctors who will 14:18:59 25 not testify, Dr. Bagnarello and Dr. Kraushaar, indicating in 17 14:18:59 1 August of 1991 Don had another brief bout with depression, 14:18:59 2 and then a couple years later in March of '93 to April of '93 14:18:59 3 he had four visits with Drs. Lougar and Buchanan. 14:18:59 4 Finally that brings us to February of 1998. In the 14:18:59 5 fall of 1997 there were a couple of stressful things that 14:18:59 6 happened in Don Schell's life. He lost his father-in-law, 14:18:59 7 his father-in-law Gerald. And he was always close with him. 14:18:59 8 He fished with him and he liked his father-in-law. That 14:18:59 9 upset him, in fact, to the point that he even got mad at his 14:18:59 10 father-in-law for dying on him and said he didn't like him 14:18:59 11 anyway or something like that. 14:18:59 12 He also lost a brother. And so he became depressed 14:18:59 13 again and he went to see the doctor. He was having trouble 14:18:59 14 sleeping, and Don and Rita went together to see a GP, or an 14:18:59 15 internist really, Dr. Patel, for sleeping pills. 14:18:59 16 Dr. Suhany had moved to Las Vegas. He didn't have a 14:18:59 17 psychiatrist. He went to see this general practitioner for 14:18:59 18 sleeping pills, and he told him that the Prozac he had had 14:18:59 19 before -- and I think another one of those doctors tried him 14:18:59 20 on it, too, the records are so bad you can't tell much about 14:18:59 21 it -- the Prozac didn't help him. It didn't help him. 14:18:59 22 Why is that significant? Because it is 14:18:59 23 significant -- you may -- as you hear all of the evidence 14:18:59 24 about warnings and what kind of warnings could be given, you 14:18:59 25 may conclude that, well, if Dr. Patel had been warned then 18 14:18:59 1 his antenna might have gone up and he might have inquired 14:18:59 2 more thoroughly into those matters. 14:19:15 3 But he was told that Prozac didn't help. And of 14:19:15 4 course if he had inquired more thoroughly, he probably would 14:19:15 5 have said, "You're one of the people that SSRIs don't work 14:19:15 6 for very well. It is your constitution, your body chemistry. 14:19:15 7 I am going to try something else on you, something that's 14:19:15 8 worked before." 14:19:15 9 So Dr. Patel gives him samples of Paxil, professional 14:19:15 10 samples left by a professional salesman with him. Two days 14:19:15 11 later at precisely the time that one would expect this kind 14:19:15 12 of adverse event from a drug, it is not uncommon to expect it 14:19:15 13 in this period of time, Don Schell in the wee hours of the 14:19:15 14 morning shot his beloved wife, his daughter and the apple of 14:19:15 15 his eye, his granddaughter, and then turned the gun on 14:19:15 16 himself. 14:19:15 17 Ladies and gentlemen, as I said, this is a case in 14:19:15 18 which we seek justice for the wrongful deaths of four 14:19:15 19 innocent people. 14:19:15 20 Now, what will be the evidence you will hear about 14:19:15 21 what SmithKline Beecham did wrong? Is it their fault? What 14:19:15 22 kind of evidence will you hear? First of all, evidence that 14:19:15 23 there were no adequate and timely warnings, indeed no 14:19:15 24 warnings at all to indicate that this drug would trigger or 14:19:15 25 precipitate violent or suicidal behavior. 19 14:19:15 1 Second, no reasonable testing, none of that 14:19:15 2 prospective testing that Dr. Wheadon learned about in Europe, 14:19:15 3 none of that rechallenge testing that Dr. Wheadon worked on 14:19:15 4 at Eli Lilly with Dr. Beasley. 14:19:15 5 Thirdly, you may hear representations that there were 14:19:15 6 misrepresentations about the safety of Paxil. 14:19:15 7 Of course, we know that the FDA has warning 14:19:15 8 requirements, and the Court will instruct you about those. I 14:19:15 9 think you will find that they're supposed to warn about 14:19:15 10 risks, specifically and particularly life-threatening risks, 14:19:15 11 without waiting for somebody to conduct the test that proves 14:19:15 12 exactly to what degree this problem is really caused. 14:19:15 13 If the drug is reasonably associated with a problem, 14:19:15 14 they're supposed to warn now. And they're supposed to convey 14:19:15 15 the warning in a manner which will bring it home to the 14:19:15 16 prescribing physician, in other words, to get their 14:19:15 17 attention. 14:19:15 18 The second witness you will hear either this 14:19:15 19 afternoon or the first thing in the morning is the Paxil 14:19:15 20 salesman that called on Dr. Patel, and you will hear him talk 14:19:15 21 about his role in emphasizing and reemphasizing warnings to 14:19:28 22 doctors like Dr. Patel to bring it to the doctor's attention. 14:19:28 23 How do you get their attention? Well, I'm trying to 14:19:28 24 get your attention, no question about it, by putting the 14:19:28 25 words "get their attention" in big, bold type. You could go 20 14:19:28 1 a step further. If it were life threatening, you could put 14:19:28 2 those words and that big, bold type inside of a black box. 14:19:28 3 You will hear a lot of evidence and testimony about black box 14:19:28 4 warnings, a warning surrounded by a black box so it catches 14:19:28 5 your eye. 14:19:28 6 Now, interestingly, there are different things on the 14:19:28 7 label for paroxetine -- remember that's Paxil -- for 14:19:28 8 paroxetine in Germany. The German label is different from 14:19:28 9 the label in this country. And yet the same company is the 14:19:28 10 one that warns those doctors there, so why don't they tell us 14:19:28 11 the same thing they tell the Germans? 14:19:28 12 You will see on the German label it says in patients 14:19:28 13 who suffer from marked restlessness and insomnia, folks just 14:19:28 14 like Don Schell, that adjuvant sedative therapy -- there's 14:19:28 15 some tenpenny words -- some other medication, an antidote to 14:19:28 16 take the edge off, an antidote like Dr. Suhany gave, some 14:19:28 17 adjutant sedative therapy may be necessary. 14:19:28 18 You will also see in the German label they say 14:19:28 19 because of unpredictable effects on the central nervous 14:19:28 20 system, especially at the start of treatment, caution is 14:19:28 21 necessary. 14:19:28 22 Well, that's Germany. How about over here? Another 14:19:28 23 expert you will hear from is this distinguished looking 14:19:28 24 gentleman with a bow tie, Dr. John Terry Maltsberger, III, 14:19:28 25 from Boston. He has devoted most of his professional career 21 14:19:28 1 to trying to learn why people commit suicide and how to help 14:19:28 2 them keep from doing that. He's a psychiatrist, a clinical 14:19:28 3 professor at Harvard and a suicidologist who has written and 14:19:28 4 researched and worked in this area for years. And he is 14:19:28 5 another of our experts in this case. 14:19:28 6 But in his deposition these fine lawyers said, "Well, 14:19:28 7 Dr. Maltsberger, you say we should give a warning. What 14:19:28 8 should it look like? What should it say?" He took a piece 14:19:28 9 of paper, he wrote one out like you will have in evidence in 14:19:45 10 about five minutes. It wasn't hard. 14:19:45 11 And here is what it said: "Physicians should be 14:19:45 12 aware that in rare instances SSRI compounds such as Paxil may 14:19:45 13 produce acute homicidal and suicidal states. Close 14:19:45 14 monitoring of patients is indicated in the course of the 14:19:45 15 first six weeks of therapy" -- "of prescription of these 14:19:45 16 drugs, especially when there's a history of unusual anxiety, 14:19:45 17 hypomania or akathisia." 14:19:45 18 And yes, he testified that in his opinion and will 14:19:45 19 testify in this case in his opinion to get the doctors' 14:19:45 20 attention and bring the message home that these words should 14:19:45 21 be in a black box. 14:19:45 22 Now, what's the big deal with the black box, you say? 14:19:45 23 Why not use a black box warning? Why do you keep mentioning 14:19:45 24 that? As you hear the evidence, what you're going to learn 14:19:45 25 is if you take that warning and you put it inside of a black 22 14:19:45 1 box, there's some things that you would do to market the drug 14:19:45 2 you can't do anymore, like reminder ads. The salesman can't 14:19:45 3 leave a mug or pen or a slim jim or prescription pad to 14:19:45 4 remind the doctor about Paxil if that drug has a black box 14:19:45 5 warning. 14:19:45 6 Television and magazine ads, why is that important? 14:19:45 7 It is important because you'll hear the testimony from the 14:19:45 8 vice-president of marketing from SmithKline Beecham, 84 times 14:19:45 9 out of a hundred that one of us goes into a doctor and asks 14:19:45 10 for a drug by name, we get that drug. But you can't do that 14:19:45 11 if there's a black box warning. 14:19:45 12 The truth of the matter, ladies and gentlemen -- you 14:19:45 13 will hear evidence from a couple of sources about it -- is 14:19:45 14 that black box warnings would have an impact on sales of 14:19:45 15 Paxil, so says the director of SmithKline Beecham and the 14:19:45 16 head of research, Dr. Tada Yamada. You will see him on the 14:19:45 17 big screen here in a video deposition. He's in Philadelphia. 14:19:45 18 Believe it or not, we can't force him to come. The court's 14:19:45 19 subpoena power extends throughout the state of Wyoming and 14:19:45 20 for a hundred miles, so someone from Denver we could force to 14:19:45 21 come, but not from there. 14:19:45 22 So we all worked together and went to Philadelphia 14:19:45 23 and said, "Let's talk to the people that have the knowledge," 14:19:45 24 so you will see several of the testimony of SmithKline 14:19:58 25 Beecham's executives on the video screen, and Mr. Yamada is 23 14:19:58 1 one of them. 14:19:58 2 You will also hear some evidence you will need to 14:19:58 3 assess and consider with regard to their lack of testing of 14:19:58 4 this drug. You will see that they've done no prospective 14:19:58 5 clinical trials, none of those forward-looking ones where the 14:19:58 6 thing they're studying is does this drug cause suicide and 14:19:58 7 violence. 14:19:58 8 Just as soon as I sit down and shut up, you will hear 14:19:58 9 a lot about other tests that were done where people went back 14:19:58 10 and said, "What can we figure out about suicide and violence 14:19:58 11 from these tests that were done?" But I don't think you will 14:19:58 12 hear anybody talk about prospective clinical trials conducted 14:19:58 13 by SmithKline Beecham to study this issue. 14:19:58 14 You will see that they never did any of the four 14:19:58 15 recommended tests that their own expert Dr. Mann recommended 14:19:58 16 in 1991 and that he reiterated again on behalf of the ACNP in 14:19:58 17 1992. They never did the rechallenge study that Dr. Wheadon 14:19:58 18 and Beasley and all the other hundred people at Eli Lilly 14:19:58 19 worked so hard to write. 14:19:58 20 They did fund one study, and you will hear Mr. Preuss 14:19:58 21 talk about it, by a fellow named Verkes over in Europe to 14:19:58 22 look at this specific issue. The problem with it is they 14:19:58 23 started with 91 patients and only 19 finished the study, so 14:19:58 24 it is kind of hard to tell about a small vulnerable 14:19:58 25 subpopulation of patients if you've only got 19 in the whole 24 14:19:58 1 study and three-quarters of the people in it dropped out. 14:19:58 2 They also have done some internal reviews. They 14:19:58 3 wrote an internal review of Paxil's association with 14:19:58 4 aggression, big thick report. It is a joint exhibit. It 14:19:58 5 will be in evidence. Each of you will have your own copy. 14:19:58 6 But what you will learn through the testimony is that 14:19:58 7 this report was never filed with the FDA and it was not 14:19:58 8 subjected to peer review and publication. It was not out 14:19:58 9 there in the public domain, and that will be an important 14:19:58 10 issue with respect to lots of scientific information. 14:19:58 11 Dr. Healy has had more access to information about 14:19:58 12 the adverse effects of these drugs than any expert in this 14:19:58 13 case or indeed in the world because he went to their 14:19:58 14 headquarters in London and looked at it, Harlow, I think, 14:20:14 15 Harlow, England. You see there's a lot of information that's 14:20:14 16 never published, never released from the drug company. 14:20:14 17 Your job at the end will be to make some decisions 14:20:14 18 about substantial factors and concurrent causes. And all I 14:20:14 19 mean is you're going to have to decide whether Paxil was a 14:20:14 20 substantial factor in causing these deaths, even if there 14:20:14 21 were other concurrent causes. Even if you think, well, 14:20:14 22 depression might make you commit suicide. I don't know about 14:20:14 23 this homicide, but it might make you commit suicide, but even 14:20:14 24 if it did, did the Paxil play a substantial role in 14:20:14 25 triggering that behavior? That's the decision you will have 25 14:20:14 1 to make under the law and evidence at the conclusion of this 14:20:14 2 case. 14:20:14 3 It is a case about SSRI drugs and suicide and our two 14:20:14 4 main points: That SmithKline Beecham has known since 1990 if 14:20:14 5 not before that there was a small vulnerable subpopulation of 14:20:14 6 patients at risk, and that Don Schell was one of those 14:20:14 7 vulnerable people. 14:20:14 8 Now, why did I say that he was one of those 14:20:14 9 vulnerable people? Simply this: He had a prior bad 14:20:14 10 experience on Prozac. It is well documented in the records 14:20:14 11 and the testimony of Dr. Suhany. He had exactly the kind of 14:20:14 12 symptoms that are the harbingers of suicide and violence. 14:20:14 13 Unfortunately, no one who saw Don under the influence 14:20:14 14 of the SSRI drug Paxil is alive. He took his wife and 14:20:14 15 daughter with him. They're not alive to tell us what they 14:20:14 16 saw. 14:20:14 17 There are two family members, though, his 14:20:14 18 mother-in-law and son-in-law, who talked to him on the phone 14:20:14 19 and he was not himself. He was abrupt with one, so shaky 14:20:14 20 with his mother-in-law she could hardly recognize him. 14:20:14 21 On Paxil Don Schell did something so bizarre and out 14:20:14 22 of his character, the only real explanation is that it was a 14:20:14 23 drug-induced frenzy or craze. 14:20:14 24 There are a couple of other points to watch for as 14:20:14 25 you assess the evidence in this case. I want to talk about 26 14:20:14 1 four of them real briefly. First is the evidence that 14:20:14 2 suggests that depression made him do it. We will come back 14:20:14 3 and talk about it. 14:20:14 4 Second, that Paxil is a different SSRI. 14:20:26 5 Third, you're going to have to try to look at the 14:20:26 6 truth behind statistics. Look cautiously at statistics. 14:20:26 7 And then there will be evidence trying to suggest to 14:20:26 8 you that Don Schell is at fault in some way for not staying 14:20:26 9 on drugs all the time. 14:20:26 10 Let's consider a couple, three of those. First, 14:20:26 11 depression made him do it. You will see evidence that 14:20:26 12 suicide is a risk of depression, but generally speaking 14:20:26 13 homicide is not. There's a rare phenomenon called 14:20:26 14 murder/suicide but it doesn't include shooting your 14:20:26 15 granddaughter multiple times. 14:20:26 16 You will learn from all of the experts, including 14:20:26 17 their expert Dr. Mann who readily concedes this, that suicide 14:20:26 18 is multi-factorial and biologically triggered. What do I 14:20:26 19 mean by that? Simply this: There are many factors. It is 14:20:26 20 never simply depression made them do it. There's always more 14:20:26 21 than one thing that is a concurrent cause, a substantial 14:20:26 22 factor. 14:20:26 23 Invariably one of them is biological, organic. It is 14:20:26 24 something the person has put into their body or some problem 14:20:26 25 like a brain tumor with their body. But it is frequently 27 14:20:26 1 reaction to some drug or alcohol, and that's the biological 14:20:26 2 trigger. 14:20:26 3 As you consider that evidence, you're going to have 14:20:33 4 to bear this depression-made-him-do-it evidence in mind with 14:20:33 5 the fact that one concurrent cause such as depression may be 14:20:34 6 continuous in operation and joined with another cause 14:20:37 7 occurring at a later time. 14:20:41 8 Now, how about Paxil is a different SSRI? Actually, 14:20:46 9 this one is going to be a little funny. What you're going to 14:20:50 10 learn from the evidence is that the company that coined the 14:20:55 11 acronym SSRI, selective serotonin reuptake inhibitor, are 14:21:01 12 these folks, SmithKline Beecham. They coined that acronym to 14:21:05 13 compete better with Prozac because they wanted to tell 14:21:08 14 doctors, "Our drug is more selective, it is more selective. 14:21:13 15 It is a cleaner drug than Prozac." 14:21:15 16 So they joined that class of drugs by coining the 14:21:20 17 term themselves, but there will be evidence from which 14:21:23 18 they'll suggest that, "Well, ours is different, really." 14:21:26 19 They all selectively inhibit the reuptake of serotonin, and 14:21:32 20 if I have time, I'll talk about what that means in a minute. 14:21:44 21 You will see from the scientific literature and the 14:21:47 22 testimony of the experts in the field that all SSRI drugs 14:21:51 23 cause akathisia, mania and psychosis, albeit to varying 14:21:56 24 degrees. Prozac is more dangerous, at least that's what all 14:22:01 25 the studies show, but Paxil is also dangerous for some 28 14:22:04 1 people. 14:22:07 2 Blame Don Schell. All I will ask you here, as you 14:22:10 3 hear all the evidence just use your common sense and see when 14:22:13 4 you weigh all of the evidence, do you want to really blame 14:22:17 5 this man or do you want to clear his good name for something 14:22:22 6 that was beyond his control? 14:22:25 7 Well, I have a few minutes left so I want to talk to 14:22:40 8 you about a few buzzwords. Any field of knowledge -- I 14:22:43 9 learned early on as a young Army lawyer working at the 14:22:46 10 Pentagon, I went to that place, "Oh, my gosh, how am I going 14:22:49 11 to function in this environment?" It is all a matter of 14:22:52 12 knowing the acronyms and the buzzwords, and that's true with 14:22:55 13 almost all of our various fields of endeavor. You will have 14:22:59 14 these things rolling off your tongue by the end of a couple 14:23:03 15 weeks. 14:23:11 16 Serotonin, let's start with that. I'm sure most of 14:23:13 17 you have heard the word "serotonin" in connection with some 14:23:18 18 medication or another. 14:23:19 19 It is a chemical neurotransmitter in the brain. It 14:23:23 20 is a chemical substance that takes messages from one cell to 14:23:27 21 the other in the brain and impacts various functions in the 14:23:29 22 brain. It has been known for years to be associated with not 14:23:33 23 only depression but with violence and suicide and 14:23:37 24 disinhibition of human behavior. 14:23:40 25 And all of these SSRI drugs were targeted to work on 29 14:23:44 1 the serotonin system. Dr. Healy is an expert in the 14:23:48 2 serotonin system. He has an M.D. and a Ph.D., and his Ph.D. 14:23:52 3 thesis was on the serotonin -- a portion of the serotonin 14:23:57 4 system. 14:23:58 5 I say system because it is fairly complex. There are 14:24:02 6 different things called serotonin receptors. And you will 14:24:06 7 see sometimes people call it serotonin, sometimes they call 14:24:10 8 it 5HT, which is the way serotonin is written. 14:24:14 9 And there are different receptors in the brain, 14:24:18 10 different little cells that the serotonin operates on. You 14:24:21 11 will see, for example, Dr. Mann eight or nine years ago when 14:24:25 12 he was writing about the small vulnerable subpopulation said, 14:24:29 13 "I think maybe the drug is affecting the 5HT-1A receptor." I 14:24:37 14 hope I've got that right. "Maybe that's what is causing 14:24:41 15 these people to behave this way." More recently he said, "I 14:24:44 16 was really wrong in that. That's not the way it does it." 14:24:48 17 You will see some other evidence indicating that 14:24:50 18 perhaps it is the impact of these drugs on the 5HT-2 14:24:55 19 receptor. 14:24:57 20 Now, none of those are the reuptake mechanism. The 14:25:01 21 reuptake mechanism is something -- the experts will explain 14:25:05 22 it far better than me -- but it is something that increases 14:25:08 23 the amount of serotonin available in the little area called a 14:25:11 24 synaptic cleft in the brain and they think if you do that, it 14:25:15 25 alleviates depression. 30 14:25:17 1 They can't really tell you why, biologically can't 14:25:22 2 explain why, but they believe it happens and it seems to 14:25:25 3 happen, you know, with 50, 60 percent of the people. And 14:25:28 4 that's the basis of the serotonin agents as antidepressants. 14:25:36 5 Selective serotonin reuptake inhibitors we've already 14:25:39 6 talked about. They include Prozac, Paxil and Zoloft. Paxil 14:25:43 7 is the brand name for SmithKline Beecham's drug paroxetine; 14:25:51 8 Prozac, for Eli Lilly's drug fluoxetine; and Zoloft for 14:25:59 9 Pfizer's drug sertraline. 14:26:02 10 And I've already talked about mania, hypomania and 14:26:07 11 psychosis. 14:26:15 12 A word or two about how the evidence will unfold. 14:26:17 13 Evidence is merely the testimony from the people that have 14:26:20 14 facts or opinions which are admissible under the law that can 14:26:23 15 help you decide what is just and fair in this case, and 14:26:25 16 documents. 14:26:28 17 And, you know, there are reams and reams of documents 14:26:31 18 that lawyers for both sides have gone through, and we've 14:26:33 19 tried to boil it down, both sides really have, to the things 14:26:36 20 that the lawyers really believe you need to see, the lawyers 14:26:40 21 on each side, to have a fair view of things. 14:26:45 22 Many of the exhibits you will receive in evidence are 14:26:48 23 joint exhibits, exhibits both sides have said, "The jury 14:26:51 24 certainly needs this exhibit." Many of the others are ones 14:26:54 25 that we thought, "Well, we really want them to look at it," 31 14:26:57 1 and they said, "Here's some we want," and those will be 14:27:00 2 admitted as well. 14:27:01 3 You will have to decide the case from the whole of 14:27:04 4 the evidence. You will hear some testimony by video 14:27:08 5 deposition. You will hear some testimony from live 14:27:12 6 witnesses. You know, I know it will hit you -- sometimes we 14:27:16 7 will be in Gillette, sometimes we will be in Philadelphia, 14:27:20 8 and you will kind of have to pay attention: "Vickery was 14:27:24 9 talking about Gillette and then he was talking about 14:27:27 10 Philadelphia." Where does this witness fit in? Are they 14:27:30 11 fitting in with what SmithKline Beecham knew, when they knew 14:27:33 12 it and what they did about it or are they fitting in with the 14:27:37 13 tragedy that occurred in Gillette, Wyoming and whether it 14:27:40 14 could have been prevented? 14:27:42 15 Mr. Fitzgerald and I are proud to represent these 14:27:45 16 people. We don't want your sympathy. We want a just verdict 14:27:48 17 that will do justice at the end of the case and we're real 14:27:51 18 confident from the jury selection process this morning, the 14:27:54 19 way this Court handles business here, that that is precisely 14:27:57 20 what we will get at the conclusion of the case. 14:28:00 21 So I'm going to give you back about five or ten 14:28:02 22 minutes, Your Honor. 14:28:03 23 Thank you, ladies and gentlemen. 14:28:05 24 THE COURT: Thank you very much. 14:28:21 25 Mr. Preuss. 32 14:28:25 1 MR. GORMAN: Can we have a couple minutes to get set 14:28:27 2 up here, Judge? 14:28:29 3 THE COURT: Sure. 4 (Pause.) 14:29:56 5 MR. PREUSS: Good afternoon. My name is Chuck 14:29:59 6 Preuss. Tom and Vern and I will be working together to 14:30:04 7 provide you with SmithKline's evidence in this case and now 14:30:07 8 it is my opportunity to address some opening remarks to you. 14:30:15 9 Members of the jury, this case isn't about two Paxil 14:30:18 10 pills. This case is about how Don Schell's deepening 14:30:21 11 depression caused him to commit this horrible crime in 14:30:24 12 February of 1998 against the three closest women in his life, 14:30:31 13 and thereby create the three victims that are here today in 14:30:38 14 this court: Tim Tobin, Rita -- Neva Schell, Flo Reavis and 14:30:53 15 other family members. 14:30:54 16 You will have difficulty resisting sympathy for these 14:30:58 17 victims. Such feelings are understandable. There is no one 14:31:03 18 in this court today whose heart does not reach out to these 14:31:06 19 individuals. 14:31:07 20 But as you will learn from Judge Beaman as this case 14:31:10 21 progresses, your final decision, your ultimate decision in 14:31:38 22 this case must be from science and not from sympathy. 14:31:38 23 So let's take a look at what the evidence will show. 14:31:38 24 Don Schell had a long history of anxiety and depression. Don 14:31:38 25 Schell failed to follow the recommendations of his physician. 33 14:31:40 1 Don Schell concealed the full history of his anxiety and 14:31:43 2 depression from his family, and more importantly, from his 14:31:46 3 physicians. 14:31:48 4 Two Paxil pills did not cause Don Schell's crime. 14:31:55 5 The facts, science and your common sense will lead you to 14:31:58 6 that conclusion. 14:32:00 7 Depression, unfortunately, is all too common an 14:32:03 8 illness, and it can lead to suicide in some cases. It is a 14:33:00 9 known fact that most suicides occur when people are 14:33:00 10 undertreated or untreated. 14:33:00 11 Paxil is an effective drug treatment. Paxil reduces 14:33:00 12 anxiety, Paxil reduces depression, Paxil reduces aggression, 14:33:00 13 and Paxil saves lives, not only the lives of the individuals 14:33:00 14 who have the depression or anxiety and need the medications, 14:33:00 15 but also those who have to care for and cope with the anxious 14:33:00 16 and depressed people in their living and working 14:33:00 17 environments. 14:33:00 18 SmithKline is proud of Paxil's records in helping the 14:33:00 19 depressed people and anxious people and those who are 14:33:00 20 affected by them. 14:33:03 21 First let's talk about Don Schell's history of 14:33:03 22 depression. Dr. Merrell, a local psychiatrist here in 14:33:07 23 Cheyenne who makes his living seeing patients on a day-to-day 14:33:12 24 basis, will relate to you the history of Don Schell's 14:33:16 25 depression and anxiety and relate it to the fateful night in 34 14:33:20 1 February of 1998. No one from whom you will hear in this 14:33:27 2 trial has made as thorough and thoughtful review of this 14:33:30 3 history and its implication for this case. 14:33:40 4 As you will note, six prior episodes of depression, 14:33:44 5 first in 1984 when Don Schell first saw Dr. Hemphill. 14:33:53 6 Dr. Hemphill was an internist, since moved to Alabama but was 14:33:57 7 practicing in Gillette. 14:34:00 8 You will hear his deposition, which is a recorded 14:34:03 9 statement of questions asked him by both sides, and he will 14:34:07 10 say Don Schell came to see him for anger, depression and 14:34:10 11 stress. However, we don't have the medical records 14:34:38 12 themselves. 14:34:38 13 Late 1988, early first quarter of 1989, the second 14:34:38 14 depressive episode occurred. Again, Dr. Hemphill was asked 14:34:38 15 to see Don Schell. The contact came, unusually, from the 14:34:40 16 wife of a colleague of Dr. Hemphill. Rita knew the wife and 14:34:49 17 Don got hooked up with Dr. Hemphill again, the two symptoms 14:34:53 18 being depression and irritability. 14:34:55 19 He was put on Prozac for about a month but Don Schell 14:34:58 20 claimed he had sexual dysfunction, was tired and decided on 14:35:02 21 his own to quit. At the end Dr. Hemphill referred Don 14:35:09 22 Schell to Dr. Bresnahan, the first psychologist to see Don 14:35:14 23 Schell, in April of 1989. 14:35:16 24 The third depressive episode occurred in 1990, the 14:35:20 25 very end of 1989 and all through '90 and early '91 when 35 14:35:25 1 Dr. Suhany, a psychiatrist, saw Don Schell. Dr. Suhany not 14:35:32 2 only treated with medications but also with psychotherapy. 14:35:35 3 That went on on a periodic basis. His diagnosis was 14:35:38 4 major depression. And again Don Schell was on Prozac. He 14:36:15 5 received benefits from that medication; however, he did 14:36:15 6 develop hand tremors which was a known side effect and was 14:36:15 7 treated with Inderal and that took care of the hand tremors. 14:36:15 8 Later Dr. Suhany switched him off of this medication. 14:36:15 9 As was the case with Dr. Hemphill on the second 14:36:15 10 visit, Don Schell was out of work two months on this 14:36:15 11 year-long period, having been out one month on the 1989 14:36:15 12 episode. 14:36:18 13 The fourth depressive episode, Don Schell was seen by 14:36:24 14 Dr. Bagnarello, also an internist. At the time Don Schell 14:36:30 15 was also seeing a psychologist, Dr. Kraushaar. Again the 14:36:33 16 diagnosis, major depression, moderate severity; treated on a 14:36:37 17 variety of medications. 14:36:40 18 Dr. Bagnarello, not happy with the progress he was 14:36:44 19 making, referred Don Schell to another psychiatrist, a 14:36:48 20 Dr. Lucas. Again, Don Schell on the fourth episode was out 14:36:55 21 of work for one month. 14:36:57 22 The fifth episode occurred in 1993. This time Don 14:37:03 23 Schell was seeing a psychologist, Dr. Lougar. Dr. Lougar 14:37:07 24 felt this was something he needed help on and asked 14:37:10 25 Dr. Buchanan, a psychiatrist, to take a look at it. 36 14:37:14 1 Dr. Buchanan saw Don Schell on three separate 14:37:18 2 occasions making a diagnosis of major depression, recurrent. 14:37:26 3 Again, Don Schell was out of work for one month. 14:37:32 4 '94 through '96, we have no records. We do know 14:37:36 5 through Father Ogg, the priest at the church where Don and 14:37:41 6 Rita went in Gillette, advised us that Sister Agnes Clair, a 14:37:45 7 professional counselor, was seeing Don on a regular basis. 14:37:48 8 However, she has passed away and the records are no longer 14:37:51 9 available, so we don't know the full nature of care and 14:37:55 10 treatment during that period of time. 14:38:05 11 Second, the evidence will show that Don Schell did 14:38:07 12 not follow the recommendations of his physicians. 14:38:10 13 Dr. Merrell will also address this point. 14:38:13 14 In 1990 Dr. Suhany recommended that Don Schell 14:38:19 15 continue his psychotherapy and medications. However, Don 14:38:22 16 Schell decided not to follow that recommendation. 14:38:25 17 In the fourth depressive episode in 1992, Dr. Lucas 14:38:29 18 recommended continued antidepressant treatment for one year. 14:38:37 19 Don Schell decided not to do that. 14:38:44 20 In 1993 Dr. Buchanan only saw him three times, 14:38:48 21 recommended follow-up after April 27, 1993. That 14:38:53 22 recommendation was not followed. 14:38:57 23 Don Schell, you will learn, was a proud man. He 14:39:01 24 believed he was stronger than his depression and he wanted 14:39:08 25 people to think he was strong and in complete control of his 37 14:39:10 1 life. As a result, he stopped treatment, whether it was 14:39:13 2 psychotherapy or whether it was medications, and he waited 14:39:17 3 too long to seek medical treatment. 14:39:21 4 Third, Dr. Merrill will testify Don Schell concealed 14:39:26 5 the extent of his anxiety and depression from the outside 14:39:30 6 world, including his family, and most importantly, his 14:39:33 7 physicians. He simply did not give a complete history of his 14:39:38 8 past episodes of depression, anxiety to each new physician as 14:39:44 9 time went on. 14:39:45 10 You will find of interest as you listen to the 14:39:47 11 evidence how little his closest family members knew about his 14:39:52 12 episodes with depression over at least the 14 years we know 14:39:55 13 about. Listen to the testimony of Tim Tobin, Neva Hardy, Flo 14:40:04 14 Reavis. None had close to a complete picture of what was 14:40:07 15 going on in Don Schell's mind. 14:40:10 16 You will recognize from their testimony and the 14:40:12 17 testimony of others who live in the community of Gillette 14:40:14 18 that the Schells were very private people who shared very 14:40:17 19 little about their personal business. 14:40:25 20 Although it is very difficult to know what goes on 14:40:27 21 behind closed doors, the evidence will show this about Don 14:40:30 22 Schell: He rarely socialized or entertained in his home. He 14:40:35 23 was always seen with Rita Schell in public. He wanted Rita 14:40:40 24 to be with him at all times. He got upset when his daughter 14:40:43 25 left the house to go to college, when his daughter married 38 14:40:46 1 and moved to Billings with Tim because he felt much better 14:40:51 2 when she was around. He had a temper and he wanted things 14:40:54 3 his own way. 14:40:57 4 He didn't share his soul. He shut out friends and 14:41:01 5 family from his innermost thoughts. Perhaps much of Don's 14:41:08 6 behavior during his episodes of depression over the years was 14:41:11 7 known to Rita Schell, but her loyalty and protective nature 14:41:17 8 kept her from discussing with others what went on behind 14:41:21 9 their closed doors. 14:41:24 10 However, her friends at ERA, the real estate company 14:41:27 11 for whom she worked, some of whom you will hear from during 14:41:30 12 the course of this trial, knew all was not well on the home 14:41:34 13 front. 14:41:37 14 All of this comes to a head during Don Schell's final 14:41:40 15 depressive episode which resulted in the horrible crime in 14:41:45 16 February of 1998. 14:41:52 17 About a year before February 1998 Don Schell lost his 14:41:59 18 brother and his father-in-law and both of these things seem 14:42:05 19 to have affected him. 14:42:09 20 Taking it right to the time of this tragedy, Don 14:42:15 21 Schell wasn't feeling too well and Tim and Debbie Tobin were 14:42:22 22 looking for a little time to get away from the baby. They 14:42:25 23 had been focusing all of their energy and they wanted to have 14:42:28 24 a night away, thought it would be a good idea to drop off the 14:42:35 25 baby at the Schells. But Don was having depression. 39 14:42:38 1 They met up on a Sunday, February 1, in Sheridan. 14:42:42 2 The Tobins came down from Billings and up from Gillette came 14:42:46 3 the Schells, and Debbie and Alyssa went with the Schells back 14:42:49 4 to Gillette, the idea being it might be good for Don Schell 14:42:54 5 to have his daughter and granddaughter there. Tim went back 14:42:57 6 to work and Tim would come down later. 14:43:00 7 Well, they spent the week. Debbie and Alyssa spent 14:43:07 8 the week in Gillette. Tim came down for the weekend. Don 14:43:07 9 was still depressed, still sad, not feeling well, not doing 14:43:11 10 well. At that time Debbie and Alyssa had a cold so they 14:43:15 11 weren't feeling well. So it was decided maybe for Don's sake 14:43:18 12 maybe we can get some help. Rita can help out taking care of 14:43:22 13 Debbie and the baby. Tim Tobin would come down later that 14:43:26 14 week and the visit would be over. 14:43:32 15 On Monday after Tim went back to Billings again, Don 14:43:36 16 Schell told his boss he needed time off work, he wasn't doing 14:43:40 17 too well. His boss will testify that Don Schell was very sad 14:43:47 18 and depressed. 14:43:48 19 On Tuesday, February 10th, he went to work but he was 14:43:54 20 almost incapable of driving himself back home and felt he was 14:44:00 21 going to have to call Rita to come pick him up. 14:44:04 22 That same day Rita called Dr. Patel, the internist in 14:44:09 23 Gillette, and said, "His nerves are shot. His nerves are 14:44:13 24 shot. He needs sleeping pills." And the telephone slip was 14:44:17 25 given to Dr. Patel. Dr. Patel told his nurse, "I need to see 40 14:44:21 1 the chart." He takes a look at the chart and didn't see 14:44:24 2 anything on the history on anxiety or depression or sleeping 14:44:29 3 problems. He said, "You've got to get some more information 14:44:31 4 here." 14:44:32 5 The nurse then called up, spoke to Rita Schell and 14:44:35 6 the telephone slip, as you'll see, has a lot of additional 14:44:38 7 information. 14:44:39 8 Dr. Patel said, "Bring him in." They made an 14:44:43 9 appointment for the next afternoon for about 2:45 p.m. 14:44:48 10 That same Tuesday Don Schell had Kevin Nelson, 14:45:32 11 somebody he knew -- Don Schell worked in the oil fields. He 14:45:32 12 was an independent contractor, checked wells and kept track 14:45:32 13 of what was going on. He therefore transferred his books 14:45:32 14 over to Kevin and said, "You have to take over for me. I 14:45:32 15 can't do it anymore." 14:45:32 16 Don Schell that day also called his investment 14:45:32 17 counselor when he got a statement and it didn't look right to 14:45:32 18 him and he was very upset. He thought something had happened 14:45:32 19 to his money and was very irritable on the phone to that 14:45:32 20 individual who responded to his call. 14:45:35 21 On Wednesday Don Schell and Rita went to visit 14:45:38 22 Dr. Patel. And Don Schell did all of the talking. Rita was 14:45:45 23 just there to kind of support him. Told something about his 14:45:49 24 history, but there were a whole bunch of things that he 14:45:53 25 didn't tell Dr. Patel. 41 14:46:08 1 He didn't tell Dr. Patel that he was unable to work, 14:46:12 2 and that, as you will learn, is a very, very significant 14:46:14 3 thing in dealing with depression, inability to work. 14:46:18 4 He didn't tell him that the day before, couple days 14:46:20 5 before he wasn't even sure he could drive himself home from 14:46:23 6 the oil field. 14:46:31 7 Some other things here by themselves probably don't 14:46:33 8 mean so much, but put them together with a prior history, put 14:46:36 9 them together with five prior depressive episodes treated by 14:46:40 10 four psychiatrists in the past, two psychologists, and one 14:46:47 11 professional counselor at the church, and the treatment 14:46:52 12 lasted with Dr. Suhany in excess of one month, one to two 14:46:55 13 months, in fact in excess of a year, one to two months on the 14:46:59 14 others, and he hadn't followed up with different 14:47:02 15 psychiatrists; that's significant information that any 14:47:07 16 physician would need to know. 14:47:14 17 Dr. Patel prescribed Paxil, gave him some samples and 14:47:21 18 prescribed the sedative Ambien to help his sleeping issue, 14:47:27 19 which according to Don Schell at that visit was the only 14:47:30 20 thing really bothering him and causing him a problem. 14:47:34 21 That same evening that they saw Dr. Patel there's 14:47:47 22 some question as to whether or not Don had a conversation 14:47:50 23 with Flo Reavis, whether it was that day or another day, but 14:47:53 24 in any case, on Thursday the 12th we have very, very little 14:47:58 25 information. 42 14:47:58 1 We do know that Tim Tobin called that evening to make 14:48:03 2 arrangements. He was coming down the next day, let them know 14:48:06 3 when he was going to be down there and pick up his wife Deb 14:48:09 4 and the baby. 14:48:12 5 And Don Schell answered the phone and did not give a 14:48:16 6 customary greeting to Tim Tobin, just passed the phone off to 14:48:21 7 Debbie. And according to Tim Tobin, she didn't talk freely 14:48:26 8 to him because Don Schell was there, because obviously he 14:48:29 9 wanted to know how Don Schell was doing. 14:48:32 10 And that's the last we know. When the police 14:48:39 11 arrived, they had a diagram where the bodies were. In the 14:48:48 12 upper right corner is the master bedroom where Rita and Don 14:48:58 13 Schell were. The guest bedroom on the lower right, in the 14:49:05 14 middle, lower section. Rita Schell was against the bed on 14:49:10 15 the wall on the top on your right and between Rita and Don 14:49:14 16 Schell were Debbie and the baby. 14:49:25 17 We are not able to tell you precisely what happened 14:49:27 18 that night behind the closed doors of the Schell household, 14:49:35 19 but this crime and the long-standing history of depression 14:49:39 20 which Don Schell tried to hide will show that no one knew the 14:49:43 21 real Don Schell or what was going on in some dark recess of 14:49:48 22 his mind. 14:49:51 23 This terrible tragedy left his remaining family 14:49:54 24 searching for an answer. No one, no one wants to believe 14:49:59 25 that their father, their father-in-law, their son-in-law, 43 14:50:03 1 their brother-in-law could do something this terrible. 14:50:10 2 So they filed a lawsuit claiming that Paxil made Don 14:50:13 3 Schell commit this crime. In fact, they say only two Paxil 14:50:19 4 pills did it. 14:50:20 5 Now, there's no question that Paxil was found in his 14:50:23 6 blood. There's no question that Paxil had nowhere near 14:50:28 7 enough time to do its job in reducing the anxiety and the 14:50:33 8 depression that Don Schell had and thereby lowering his risk 14:50:38 9 of violence or suicide. 14:50:40 10 There's no question that depressed people, 14:50:43 11 particularly men as they get older, can commit violent acts 14:50:47 12 including homicide and suicide. 14:50:50 13 Unfortunately murder/suicides do occur, whether the 14:50:56 14 person is or is not on antidepressant medication. It is not 14:50:59 15 as rare as you might think and it always ends with tragic 14:51:04 16 effects. 14:51:05 17 The question in this case is whether Don Schell's 14:51:08 18 murder/suicide was caused by only two days of a 20 milligram 14:51:12 19 tablet of Paxil. SmithKline contends that there's no 14:51:18 20 reliable scientific evidence that Paxil causes suicide or 14:51:22 21 homicide, and in the case of Don Schell, that two Paxil pills 14:51:27 22 caused him to kill the three closest women in his life. 14:51:32 23 Don Schell's depression overcame him. The facts, the 14:51:38 24 science and your common sense will tell you that as you hear 14:51:42 25 the evidence in this case. 44 14:51:45 1 Let's talk about depression. Dr. Mann, our expert 14:51:52 2 witness and one of the foremost authorities in depression and 14:51:55 3 suicide, will explain the seriousness of depression as a 14:51:59 4 mental illness and the importance of prompt medical 14:52:03 5 treatment. 14:52:04 6 Depression is characterized by feelings of 14:52:06 7 worthlessness, hopelessness and guilt. Depression is known 14:52:11 8 to cause suicide and violence, so it can be life threatening. 14:52:16 9 A risk of suicide can persist even after treatment has begun 14:52:21 10 until significant remission of the depression occurs. 14:52:27 11 Major depression, which Don Schell had, is a sad or 14:52:34 12 empty mood which doesn't just go away after a couple weeks. 14:52:39 13 Everyday activities like sleeping, socializing, working can 14:52:43 14 be affected, as they were in Don Schell's case. 14:52:46 15 No single cause of depression is known. The genetic, 14:52:52 16 biologic, psychologic and social factors all play a role. 14:52:56 17 Certain life difficulties such as stress at work can 14:53:00 18 contribute to depression, and work, as you will learn, was a 14:53:05 19 big stressor in Don Schell's life. 14:53:08 20 More than 19 million Americans, one in ten adults, 14:53:12 21 experience depression each year. 15 percent of the 14:53:16 22 population have depression at some time in their lives. 15 14:53:19 23 percent of the population which have severe major depression, 14:53:23 24 as Don Schell did, take their own lives. 14:53:29 25 Paxil is an effective treatment for anxiety and 45 14:53:33 1 depression. It is a member of a class of antidepressants 14:53:38 2 known as selective serotonin reuptake inhibitors, or SSRIs. 14:53:45 3 Serotonin is a neurotransmitter or a chemical which 14:53:50 4 transports a chemical between the nerve cells and the brain. 14:53:53 5 Serotonin function is believed to be a factor in depression 14:53:56 6 and aggression. And Paxil is believed to work by increasing 14:54:01 7 the amount of serotonin available to the nerve cells and the 14:54:07 8 brain. 14:54:07 9 It is a prescription medication so you can only get 14:54:11 10 it through a physician. Paxil, Prozac, Zoloft are the most 14:54:18 11 commonly known antidepressants within the SSRI class. 14:54:25 12 Although there is a class known as SSRIs, there are many, 14:54:29 13 many differences among them. And as our pharmacological 14:54:34 14 expert, Dr. Frazer, will explain, each SSRI must be examined 14:54:41 15 individually on the issues of efficacy and safety. To know 14:54:45 16 what Paxil does, you have to study Paxil. 14:54:50 17 I ask you to listen to the testimony of plaintiffs' 14:54:52 18 experts and ask yourselves whether they're talking about 14:54:55 19 Paxil or some other -- or some other SSRI. 14:55:04 20 David Wheadon, the vice-president of SmithKline, will 14:55:11 21 testify. He's also a psychiatrist, and he will relate to you 14:55:13 22 the Paxil story. He will discuss with you the development of 14:55:19 23 the drug leading to its approval for depression by the FDA in 14:55:23 24 the U.S. in December of 1992. 14:55:28 25 This chart I know may be a little difficult to read, 46 14:55:31 1 but included early on is the analysis of suicidality which 14:55:40 2 was requested by the FDA and provided by SmithKline to the 14:55:47 3 FDA, and there was no finding by the FDA of a link between 4 Paxil and aggression or suicide. 14:55:54 5 It involved a review of clinical study for safety and 14:55:58 6 efficacy involving thousands of patients. Dr. Wheadon will 14:56:04 7 discuss how it has gained approval since then from the FDA 14:56:09 8 for additional indications for use. 14:56:11 9 You see on the top in the white boxes there, those 14:56:15 10 are for obsessive-compulsive disorder, panic disorder, social 14:56:19 11 anxiety and general anxiety disorder. On each occasion, each 14:56:30 12 subsequent approval, the SSRI information was provided by way 14:56:37 13 of study to the FDA and approval obtained. 14:56:41 14 Interspersed from early 1991 are numerous analyses of 14:56:49 15 suicidality: A study on OCD, or obsessive-compulsive 14:56:55 16 disorder, suicidality, 1995; 1996, suicidal ideation and 14:57:03 17 aggression, suicidal ideation being ideas of suicide; 14:57:08 18 aggression again in 1999, data thoroughly reviewed again in 14:57:13 19 2001, 2000. All of these analyses were done to make sure 14:57:20 20 there was no signal linking Paxil with either aggression or 14:57:25 21 suicide. 14:57:26 22 Dr. Wheadon will affirm SmithKline's willingness to 14:57:33 23 be responsible for the safety and efficacy of Paxil. He will 14:57:42 24 express his desire to have Paxil available to people in 14:57:46 25 trouble with their depression if their physicians believe 47 14:57:51 1 that particular medication is right for them. 14:57:54 2 He will express his personal belief based on his long 14:57:57 3 experience with Paxil at SmithKline that Paxil saves lives by 14:58:02 4 helping those people that are depressed or anxious, helping 14:58:05 5 those people around the depressed and anxious individuals. 14:58:10 6 And he will express his regret that Don Schell did 14:58:14 7 not have enough time to let Paxil work for him and hopefully 14:58:20 8 prevent a horrible crime that occurred in 1992. 14:58:25 9 Plaintiffs are contending in this case that somebody 14:58:29 10 should have put something in his warning to the effect that 14:58:33 11 Paxil may cause suicide in some people. Here's what our 14:58:38 12 label says about suicide: "The possibility of a suicide 14:58:41 13 attempt is inherent in depression and may persist until 14:58:44 14 significant remission occurs. Close supervision of high-risk 14:58:48 15 patients should accompany initial drug therapy. 14:58:51 16 Prescriptions for Paxil should be written for the smallest 14:58:54 17 quantity of tablets consistent with good patient management 14:58:59 18 in order to reduce the risk of overdose." 14:59:06 19 Dr. Mann will confirm what the company data shows 14:59:08 20 internally, and that is that there is no reliable scientific 14:59:12 21 evidence that Paxil causes either suicide or violence. 14:59:18 22 Dr. Wang, who is an expert who will testify on 14:59:22 23 SmithKline's behalf in the analysis of studies where you look 14:59:26 24 to see if there is a safety risk, will comment upon the 14:59:29 25 scientific literature. These are studies that will be 48 14:59:40 1 reviewed with you. The names of the lead authors on the 14:59:43 2 left, the bottom one will include the data that comes from 14:59:48 3 our own healthy volunteer studies at SmithKline. The issues 14:59:57 4 in red were the issues examined and in each case it is shown 15:00:00 5 that Paxil is not a cause of suicide or homicide. 15:00:09 6 Our experts will also show that the literature relied 15:00:13 7 on by plaintiffs does not pertain to Paxil and is not of the 15:00:18 8 type that would reasonably support any conclusion that Paxil 15:00:23 9 can cause suicide or violence. 15:00:33 10 For example, the plaintiffs rely heavily on an 15:00:35 11 article by Dr. Donovan, and here's what the authors 15:00:45 12 themselves in the study the plaintiffs rely on has to say 15:00:48 13 about cause and effect relationship: "Establishment of cause 15:00:52 14 and effect for persistence of DSH which is associated with 15:00:57 15 different antidepressants seen in the study is therefore 15:01:01 16 almost impossible," and that is a principal study upon which 15:01:06 17 they're relying. 15:01:17 18 The label which I showed you a portion of that deals 15:01:19 19 with suicide is submitted as part of any NDA submission of 15:01:25 20 depression initially. It is reviewed on a constant basis 15:01:29 21 with the FDA and reviewed internally based on information 15:01:32 22 that may be published in the scientific literature or may 15:01:35 23 come to the company's attention through adverse experience 15:01:43 24 reports where physicians report their experience. So it has 15:01:43 25 constant attention and is looked at. 49 15:01:45 1 And our experts will testify that Paxil does not 15:01:51 2 cause suicide, does not cause homicide, that there is no 15:01:54 3 reason to change the label as I have shown it to you. 15:02:01 4 In summary, the evidence will show that two pills did 15:02:05 5 not cause Don Schell to commit this crime. Two pills were 15:02:10 6 simply not enough to prevent this tragedy from occurring. 15:02:16 7 There's no reliable scientific evidence to show that Paxil 15:02:20 8 can cause suicide or violent behavior, and there's no basis 15:02:24 9 for a change in the warning, which was adequate in 1998 and 15:02:31 10 is adequate today. 15:02:33 11 Don Schell's depression and his failure to seek 15:02:36 12 medical attention earlier and to disclose the depth of his 15:02:40 13 history of depression and anxiety past and present to 15:02:44 14 Dr. Patel led to this horrible crime and the death of the 15:02:49 15 three women closest to him. 15:02:56 16 At the conclusion of the trial the court will 15:02:59 17 instruct you on the burden of proof and the burden of proof 15:03:02 18 rests with the plaintiff on two crucial issues and that means 15:03:07 19 that they have to show it is more likely than not, as the 15:03:10 20 court will explain, that Paxil does not cause violence or 15:03:15 21 suicide and that the Paxil labeling was inadequate. 15:03:20 22 We submit that the evidence will be lacking from the 15:03:23 23 plaintiffs and SmithKline will ask for your verdict at the 15:03:26 24 conclusion of this case. Thank you. 15:03:29 25 THE COURT: Thank you, Mr. Preuss. We're ready to 50 15:03:32 1 begin with the evidence. Maybe we ought to take our 15:03:36 2 afternoon recess. 15:03:38 3 Are you all right with that, Mr. Vickery? 15:03:40 4 MR. VICKERY: That's fine. That will give us a 15:03:41 5 chance to change the equipment and everything. 15:03:43 6 THE COURT: Be a 15-minute recess and we will 15:03:46 7 readjourn at, by this clock anyway, ten after 3:00. 15:03:55 8 (Recess taken 2:55 p.m. until 3:10 p.m.) 9 10 * * * * * * * * * * 11 12 (Testimony of Regina Kuhl, Tim Haase not transcribed.) 13 (Videotape Deposition of Christina Blumhardt played.) 14 (Trial proceedings recessed 15 5:00 p.m., May 21, 2001.) 16 17 18 19 20 21 22 23 24 25 51 1 C E R T I F I C A T E 2 3 I, JANET DEW-HARRIS, a Registered Professional 4 Reporter, and Federal Certified Realtime Reporter, do hereby 5 certify that I reported by machine shorthand the excerpted 6 trial proceedings, Volume I, contained herein, and that the 7 foregoing 50 pages constitute a true and correct excerpted 8 transcript. 9 Dated this 2nd day of July, 2001. 10 11 12 JANET DEW-HARRIS Registered Professional Reporter 13 Federal Certified Realtime Reporter 14 15 16 17 18 19 20 21 22 23 24 25