1 1 NO. 90-CI-06033 JEFFERSON CIRCUIT COURT DIVISION ONE 2 3 4 JOYCE FENTRESS, et al PLAINTIFFS 5 6 VS TRANSCRIPT_OF_THE_PROCEEDINGS __________ __ ___ ___________ 7 8 9 SHEA COMMUNICATIONS, et al DEFENDANTS 10 11 *** 12 13 14 FRIDAY, SEPTEMBER 30, 1994 15 VOLUME V 16 17 * * * 18 19 20 _____________________________________________________________ 21 REPORTER: JULIA K. McBRIDE Coulter, Shay, McBride & Rice 22 1221 Starks Building 455 South Fourth Avenue 23 Louisville, Kentucky 40202 (502) 582-1627 24 FAX: (502) 587-6299 25 2 1 2 I_N_D_E_X _ _ _ _ _ 3 4 Conference............................................... 5 Opening Statement by Mr. Smith........................... 6 Opening Statement by Mr. Stopher......................... 7 Opening Statement by Mr. Freeman......................... 8 Conference............................................... 9 Reporter's Certificate................................... 10 11 * * * 12 13 14 15 16 17 18 19 20 21 22 23 24 25 3 1 2 A_P_P_E_A_R_A_N_C_E_S _ _ _ _ _ _ _ _ _ _ _ 3 FOR THE PLAINTIFFS: 4 PAUL L. SMITH 5 Suite 745 Campbell Center II 6 8150 North Central Expressway Dallas, Texas 75206 7 NANCY ZETTLER 8 1405 West Norwell Lane Schaumburg, Illinois 60193 9 IRVIN D. FOLEY 10 Rubin, Hays & Foley Third Floor South 11 First Trust Centre 200 South Fifth Street 12 Louisville, Kentucky 40202 13 FOR THE DEFENDANT: 14 EDWARD H. STOPHER 15 Boehl, Stopher & Graves 2300 Providian Center 16 Louisville, Kentucky 40202 17 JOE C. FREEMAN, JR. LAWRENCE J. MYERS 18 Freeman & Hawkins 4000 One Peachtree Center 19 303 Peachtree Street, N.E. Atlanta, Georgia 30308 20 21 ALSO PRESENT: 22 DR. W. LEIGH THOMPSON 23 24 25 4 1 The Transcript of the Proceedings, taken before 2 The Honorable John Potter in the Multipurpose Courtroom, Old 3 Jail Office Building, Louisville, Kentucky, commencing on 4 Friday, September 30, 1994, at approximately 9:30 A.M., said 5 proceedings occurred as follows: 6 7 * * * 8 9 (THE FOLLOWING PROCEEDINGS OCCURRED IN ROOM 148) 10 JUDGE POTTER: Mr. Higgs, I've talked about your 11 situation with the attorneys and they have agreed that you can 12 be excused. I take it your situation has not changed since 13 yesterday? 14 JUROR HIGGS: I felt when I left yesterday that 15 I wasn't going to be released and I talked to my employers and 16 I have something worked out to where I'm just going to work 17 the weekends and work nights. 18 JUDGE POTTER: Okay. Now, that leaves one 19 question. Is this going to put you -- and, again, I said it 20 was my decision and I told you yesterday if the lawyers had 21 agreed on something -- and this is an important case and, 22 obviously, because you're here, this is a case in which both 23 sides said you're an acceptable juror to them. 24 JUROR HIGGS: I understand, Your Honor. 25 JUDGE POTTER: And you just have to answer a 5 1 question. And maybe I shouldn't have told you what they'd 2 agreed on first. But is this a situation where because you're 3 working at night you're going to be so tired -- are you going 4 to just work a couple hours at night or what are we talking 5 about? 6 JUROR HIGGS: I'm going to leave from the 7 courtroom and work till midnight. 8 JUDGE POTTER: What you have to tell me, is this 9 going to put you in a situation -- first of all, sir, let me 10 say I admire you and I think if I had known about your 11 rehabbing your house I would have done something before today. 12 Do you understand what I mean? 13 JUROR HIGGS: Yes, Your Honor. 14 JUDGE POTTER: I knew your income. I knew you 15 would lose it, but I don't believe that a jury -- I think we 16 try and get as many different people as we can. So what I'm 17 trying to ask you, sir, is we accept you as a juror if you 18 believe that, A, working at night won't put you in such a 19 sleep-deprived situation that you can't give this case your 20 attention or that you're going to try and take it out on 21 somebody because you've been put in this situation, and you 22 just have to tell me what the answer is. I know what the easy 23 answer for you is, but I want to know what you really -- 24 JUROR HIGGS: In all honesty, I believe that I 25 probably could give the case full attention. Yesterday I 6 1 think you felt I was upset. 2 JUDGE POTTER: And you were, and you probably 3 had a right to be. 4 JUROR HIGGS: Well, Your Honor, I believe you 5 were mistaking upset from being scared. 6 JUDGE POTTER: I would have been upset in your 7 case. 8 JUROR HIGGS: I was upset for my family. I've 9 made other arrangements. And to be perfectly honest with you, 10 yes, I believe I could. 11 JUDGE POTTER: Thank you very much, sir. We 12 will seat you as a juror. 13 (JUROR HIGGS LEAVES THE ROOM) 14 JUDGE POTTER: Let me bring up two things. One, 15 Ms. McBride needs to talk to you-all sometime today about the 16 rent on the room she's using up there. You-all just need to 17 get it straight whether she's responsible or it comes out of 18 the total fee or whether, you know, you-all are responsible, 19 and I mentioned it to her and she said it wouldn't be any 20 problem; you-all would resolve it one way or another. But 21 it's just those rooms up there I didn't get involved with, but 22 somebody from the County or something called me and said -- 23 talked to people and got different stories. You need to get 24 that set. 25 MR. FREEMAN: As far as I'm concerned, charge 7 1 the expense and we can split it. 2 MR. SMITH: That's fine. 3 JUDGE POTTER: And I didn't mean to push you 4 into a decision today. 5 I tell you what happened with him and me. I do 6 fine on decisions if there's a right or wrong or I can see a 7 logical decision, but when it comes to discretionary 8 decisions, I have an awfully bad habit of if I see something 9 is too easy or the popular way out or something, I resist it, 10 and that's what happened with some of these excuses. And it's 11 gotten me in a lot of trouble other times, and I guess it's 12 what we all have a calvinist background or whatever it is, and 13 I should have like a stall light or something when I see 14 myself going into that. I came that close, you know, when you 15 had four of them that couldn't do it, of letting them all go 16 because it was an even bag and I should have done that. Some 17 were good for one or the other. I still could kick myself. 18 Putting in six was just troubling people to make me feel safe. 19 The plan for today: up to two and one-half 20 hours. Let me -- per side. Let me know if you want to break. 21 The way you do that: "Judge, I think this would be a good 22 time to take a break." Okay? I'll leave it up to you. One 23 break per side. We'll take 15 minutes. Obviously, we will 24 take lunch. Obviously, you're not obligated to take two and a 25 half hours. We will take lunch between the two of you. We'll 8 1 start our routine at one and a half. We will finish that 2 today. I think we need to have a meeting, you know, like 3 after it's all over, have people sort of calm down, and we'll 4 have a meeting this afternoon to find out about your witnesses 5 and to talk about some other things to get it planned out for 6 next week. 7 MR. SMITH: Judge, I'm going to be making the 8 entire argument for our side. Obviously, two and a half hours 9 is a long time to talk. And, you know, I don't know whether 10 I'm going to get winded or not. I'm just wondering if maybe 11 after 30 minutes I might be able to sit down and reshuffle my 12 notes or something just to get off my feet a little bit. 13 Could I say, "Judge, may I have two minutes to confer with co- 14 counsel"? 15 JUDGE POTTER: And I'll have them stand in the 16 jury box and stretch. We'll do that. And if you want a real 17 break, say it, and we'll take 15 minutes. 18 MR. SMITH: I don't think I could talk about 19 anything for two and a half hours. 20 JUDGE POTTER: You go to the seminars and they 21 tell you everything over 20 minutes is lost. But this is a 22 long trial and you said you didn't want two hours. They said 23 they wanted two and a half. And so that's as long as we keep 24 it, to two and a half. And whoever -- who's going first on 25 your side, Mr. Stopher? 9 1 MR. STOPHER: I will, Judge. 2 JUDGE POTTER: Okay. Mr. Freeman, I will remind 3 you, you know, if your time gets close to the end I will cut 4 you off, because I'm assuming you're going to take a great 5 deal more time than Mr. Smith. The other thing is I'm not 6 saying there can't be a little overlap, but it's not going to 7 be repeated twice. You're drug and you're Wesbecker; is that 8 where we are? 9 MR. STOPHER: That's where we are. 10 MR. FREEMAN: And I just have some conclusionary 11 remarks to make about what Ed said. 12 13 * * * 14 15 SHERIFF CECIL: All rise. Silence is commanded 16 while the Honorable Judge John Potter is now presiding. Court 17 is now in session. Please be seated and remain silent. 18 JUDGE POTTER: I'm going to move over here 19 because it is this first part; it's important or not 20 important, but I would like to see the jury. Let me make a -- 21 I tell you what. Can I get someone to move the easel just for 22 this time being? Okay. 23 Good morning, ladies and gentlemen. Let me 24 start and give you kind of some information about how this is 25 going to go. I think all of the parties here think you know a 10 1 lot more about what's going on than you actually do because 2 we've talked to each of you, you know, 10 minutes or so apiece 3 and in our mind that adds up to 160 minutes. So we feel like 4 we've spent an hour or two with you where, really, from your 5 point of view, we've only spent 10 minutes. So I think all of 6 us kind of have a feeling you know a lot more about what's 7 going on down here than actually is. So let me start with 8 what our daily routine will be. We're going to start at 9:30 9 on Monday mornings and then on Tuesday, Wednesday, Thursday 10 and Friday, we start at 9:00. The reason for that is that I 11 have a commitment every Monday morning at 8:30. The judges in 12 Division One have to do something at 8:30. I can tell you 13 there will be a judge doing that 8:30 six years from now every 14 Monday morning. So I have that commitment, and that's why 15 we'll start a little late on Monday morning. 16 We will stop at 5:00, Monday through Thursday. 17 It will actually be probably 4:30 to 5:30, depending on 18 whether there's a good break between the witnesses. Is there 19 anybody here because of child-care commitments or any other 20 commitments could not stay till 5:30 if that's what it 21 happened to be? Okay. 22 On Friday we will have a half a day. And the 23 reason for that is there's some out-of-town attorneys and that 24 allows them to do some things that they couldn't do otherwise. 25 And, also, it gives the Court and the Counsel an opportunity 11 1 to take up some things that maybe we need to deal with outside 2 of your presence, and we make sure the next week goes 3 smoothly. 4 So, we will take an hour and a half for lunch 5 each day. I know you'd rather probably have a shorter lunch 6 break and go home a little earlier. The reason we're taking 7 an hour and a half is two reasons: As you might guess, some 8 of these attorneys have more than one client or more than one 9 case, and it gives them an opportunity to return a phone call 10 or something like that during the lunch breaks. It also gives 11 them and me an opportunity to take up something if it needs to 12 be taken up outside of the presence of the jury. We'll try 13 and take two breaks a day; one in the morning and one in the 14 afternoon. So to kind of summarize the schedule, I guess you 15 could think of it as nine to five, five days a week, except on 16 Mondays we start a half hour late, and on Fridays we'll have a 17 half a day. 18 Let me go over some dates with you. We will not 19 try the case Friday, November 4th. And the reason for that is 20 it is the Breeders' Cup and there are no hotel rooms available 21 Thursday night. Okay. I mean, that's the reason for that. 22 It's anticipated that we will finish this before Thanksgiving, 23 but if for some reason we don't, there would be no Court the 24 week of Thanksgiving. You know, if you need to check that 25 schedule or anything, let me know and let my sheriff know and 12 1 she'll give it to you again. I know this is information 2 that's flowing over you kind of fast. 3 Let me talk a little bit about your conduct 4 during this trial. I'm going to ask you all to follow my 5 admonition, of course, and that I give it to you every time we 6 recess. And the reason I do that is because it's important, 7 and if I don't do that, I'm afraid you'll kind of forget about 8 it. So when I give it to you all the time, I do it because 9 it's important, and I will ask you-all periodically as a group 10 or perhaps individually if you've had any problems obeying 11 that admonition. Has anyone had any problem abiding by my 12 admonition about the newspaper and talking to people about it 13 over last night's break? Just to pick on somebody, Mr. Fitch, 14 since you're in the first row, have you had any problems with 15 it? 16 JUROR FITCH: I don't have a problem; no, sir. 17 JUDGE POTTER: Okay. I'm going to ask you-all 18 to wear your juror badges, and the reason for that is so we'll 19 know who you are. And not just in the courtroom. Actually, 20 in the courtroom we know who you are because we look at what 21 seat you're sitting in; right? It's so when you're waiting 22 for your bus -- you can take it off once you get on the bus 23 and start going home -- or if you're over in the park enjoying 24 a pretty day on a break or walking around, people will know 25 that you're a juror, and a lawyer won't come up to you or talk 13 1 to you by mistake or somebody that's an old friend that's 2 going to be a witness in this case won't come up and talk to 3 you by mistake. It's just important that we know who you are. 4 I'm going to ask you-all to come and go through 5 this rear door that you've used as much as you can and to use 6 the jury room as much as possible. And the reason for that is 7 to keep you separate from the witnesses and the parties in the 8 case. I'm going to try to get a little refrigerator and have 9 them put it in the jury room so you can bring a lunch if you 10 want to or have Cokes or whatever. And that's to separate you 11 from the witnesses and the parties. 12 You-all don't realize it that you-all have -- 13 everybody wants to do the right thing and you-all have little 14 antennae out to pick up absolutely every clue. All right. 15 And why we try and separate you is not because somebody will 16 do something improper so much as these little antennae would 17 be trying to get clues. And you're supposed to decide the 18 case on what happens here in the courtroom, not because of 19 what you see out in the hallways. Do you understand what I'm 20 saying? And I'll tell you 99.9 percent of the clues you get 21 that way are going to be wrong. Okay. 22 One of the things you're not supposed to do is 23 try and read this case by what I do. Okay. If I come in here 24 in a bad mood, it's not because the case is going badly or 25 somebody didn't do well, it's because my cat got sick the 14 1 night before. All right. And you-all will be sitting there 2 looking for clues and put some significance in that. And you 3 don't realize that now, but each one of you wants desperately 4 to do the right thing, and that's fine, and you're trying to 5 get help every way you can. And one of the ways you're not 6 supposed to get help is because of how I'm acting that day or 7 how one of the plaintiffs is acting that day or whether a 8 plaintiff is here or absent that day. You base it on what the 9 lawyers do -- well, you don't even base it on what the lawyers 10 do; you base it on what the witnesses say and the evidence 11 that comes in. If you have any concerns about, you know, 12 something, you can talk to my sheriff. 13 Let me talk about my conduct, the parties' 14 conduct, the attorneys' conduct. I really won't speak to 15 you-all very much except nod or say "Good Morning" or I'll 16 talk to you with everybody present, with the lawyers and 17 everybody present. And the reason I do it with everybody 18 present because I just don't know what you-all are going to 19 say. I've had many times a juror says, "Judge, can I talk to 20 you." Get the lawyers up here, get the Court Reporter in, and 21 they want to know if they can get a back brace to put in their 22 chair because a pillow is bothering them or something. We 23 just never know what it is. Anytime I talk to you-all beside 24 "Good Morning," we'll get all the lawyers together and the 25 Court Reporter. 15 1 The attorneys will treat you the same way except 2 they won't even -- they'll just say "Good Morning" and they 3 won't even be able to get you together and talk to you if they 4 wanted to. Okay. So they'll just nod. So don't think 5 they're being rude, don't think they aren't concerned about 6 you; that's just we try and separate you from things happening 7 outside the courtroom. If you want to talk to me, let my 8 sheriff know and we'll get everybody together. What I'd like 9 to strike on that is kind of a balance. I don't want to be in 10 the position of carrying on a conversation with you-all 11 throughout this trial. Okay. So I would say if you want to 12 talk to me, kind of use that "contact my sheriff" sparingly. 13 Now, you can contact her about -- it seems to be a little 14 cooler in here today, doesn't it -- about the temperature, 15 asking her about what time things are going to start; do you 16 have time to go get something out of your car before we start, 17 all that kind of stuff. But I don't want you to feel like you 18 can't ask me a question. In other words, I don't want one of 19 you sitting there not able to concentrate on this case because 20 you've got some question in your mind that could be taken care 21 of like that if we could answer it. Maybe the question is a 22 simple answer; the answer may be we can't answer it, but at 23 least you could put it out of your mind instead of just 24 sitting there having to worry about it. 25 I know you-all are going to be a little lonely 16 1 throughout this trial. My suggestion is for you to bring a 2 book and read, talk to each other on anything but this case 3 and enjoy yourself as much as you can. 4 There are two questions jurors often ask, and I 5 think I'll just go ahead and answer them because I bet out of 6 the group at least one of you has got these questions. The 7 first one is: Can you take notes, and the answer is yes, but 8 I want to say a couple of things about that. And before we 9 start this trial, my sheriff has got 16 tablets and pencils, 10 and if anybody wants them you can have them. But let me say 11 something about notes. Let me first talk to those of you that 12 take notes. And there's no preferred way to do it. Some 13 people feel better concentrating and listening to things, 14 other people feel better taking notes when they hear things. 15 But those of you who take it, don't let it distract you 16 because it can happen that you're taking notes on Point A and 17 you totally miss what comes next. Okay. So don't let the 18 notes become sort of all consuming for you to the point where 19 you perhaps miss some things. And then also don't be a slave 20 to your notes. Don't refuse to change your mind because 21 something is or is not in your notes. Okay. Your notes are 22 merely an aid to help you and they can be wrong, just like 23 anything else. 24 Let me say something to those of you who don't 25 take notes. Do not be intimidated by somebody that takes 17 1 notes. Okay. Don't fail to put your opinion or your view 2 through forcefully simply because somebody has a piece of 3 paper or had a piece of paper with something written down on 4 it. Okay. 5 With that -- oh, another point, to kind of keep 6 things orderly, for those of you that have notes, what I'm 7 going to do is -- the tablets you're going to be given are 8 spiral binders, you know, it's a spiral wire, not a three-ring 9 binder, with front and a back. If you'll put your name on it, 10 close it. Whenever we go on breaks, leave it in your seat, 11 and just to kind of keep things orderly, my sheriff will 12 collect them up -- you know, leave them in your seat, she will 13 collect them up at the end of each day, put them in a folder, 14 put them in a secure place and have them there for you 15 tomorrow. No one is going to read them. No one is going to 16 look at them. That's just kind of a housekeeping measure. 17 Also, you-all are not getting paid enough to where you need to 18 work overtime by going home and studying your notes and adding 19 to them and subtracting to them. Okay. Does anybody have any 20 problem with that procedure on the notes? Okay. Do you have 21 the pads here? 22 SHERIFF CECIL: Yes. 23 JUDGE POTTER: Okay. Is there anyone here that 24 would like a pad or a pencil? 25 JUDGE POTTER: Okay. Why don't you bring them 18 1 all out and pass them around. Let me say this. Just because 2 you take the pad now doesn't mean you're committed to taking 3 notes the whole time, and if you don't take a pad it doesn't 4 mean that you can't change your mind and get one tomorrow. 5 All right? 6 (SHERIFF CECIL PASSES OUT TABLETS) 7 JUDGE POTTER: And the first thing you'll do, 8 please, is write your name on the front of it so you don't 9 pick up somebody else's. I think she has a couple of types of 10 pens, so if you've got a ballpoint fetish, she can take care 11 of you; if you've got a felt tip, she can take care of you. 12 Everybody set on that? And, again, I remind you if you didn't 13 take a tablet feel free to pick one up later, and if you get 14 tired of taking notes you're not obligated, really. 15 Another thought that jurors often have is 16 whether or not they can ask questions. The answer is yes, but 17 let me say a few things. First of all, let me tell you how to 18 do it. Okay. If you want to ask it orally in Court, wait 19 till the witness is absolutely through and about to leave the 20 witness stand. Okay. The reason for that is I'm sure when a 21 witness first takes the stand you've got a couple of 22 questions, and the person will probably answer them while 23 they're on the stand. Okay? So wait until the split second 24 before the witness is ready to leave. The other way you may 25 do it, if you want, is to write it down, give it to my sheriff 19 1 during one of the breaks and then -- if you want to ask a 2 question, I'll call you up to the Bench and it's a question we 3 may not ask for one reason or another, but we'll ask you to 4 state it up here and then it may or may not get asked. 5 Another way to do it is to write it down, give it to my 6 sheriff, and during a break -- you can do it with or without 7 your name on it, or whatever -- she will bring it to us and, 8 if it's a proper question, we'll try and see that it gets 9 asked. But before you exercise that right, let me say a few 10 things. The lawyers know a great deal about this case and 11 they have done a lot of time trying to figure out how the best 12 way to present it. The whole case does not have to come in 13 through the first witness, the second witness or any 14 particular witness, and the odds are that any questions you 15 have about this particular witness is going to be asked and 16 cleared up at a later witness. Do you understand what I'm 17 saying? The first witness is not going to be the whole case. 18 And I'm sure after the first witness you're going to have 19 thousands of questions, okay, or even before the first 20 witness. But the whole case does not have to come in through 21 that witness, so the fact that something is unanswered does 22 not mean it is not going to be answered. 23 Also, as far as maybe not remembering a 24 particular point, when you finally get back to the jury room, 25 you will have 11 other people to help you reconstruct what 20 1 went on. And my experience has been that a jury of 12 people 2 almost has a tape-recorder-like memory. I've had juries come 3 out and -- the question after they're deliberating -- and say, 4 "Judge, would you tell us what Mr. Smith said right after he 5 said this and right before he said that," and everyone is 6 sitting there scratching their head, not really remembering 7 the testimony, but we get it and look it up and, by George, 8 Mr. Smith said exactly what the jury said before and exactly 9 what the jury said he said afterwards. So I remind you that 10 you will have 11 people back there to help you reconstruct 11 what went on in here. 12 Also, the lawyers may intentionally leave 13 something out. It's not so much I think they're trying to 14 hide something from you. It's a lot of times something that's 15 not that important. If it comes in then leads to this 16 explanation which leads to that explanation which leads to 17 this explanation, and you end up being distracted, sort of 18 chasing some rabbits. So a lot of times there is something 19 that might have some relevance that they intentionally leave 20 out, and that's a decision they make. So before you decide to 21 exercise your right to ask a question, I would ask that you 22 keep those thoughts in mind. 23 Let me go over the sequence of the trial, how it 24 will proceed. Are you-all picking up kind of a whaaa? I 25 don't know where it's coming from. I think it's coming from 21 1 here; maybe if I move something a little bit. No. That makes 2 it worse, doesn't it? Well, we'll get that fixed before 3 Monday. 4 The trial will begin with opening statements. 5 This is a statement by the lawyer of what that lawyer thinks 6 the evidence is going to be. You will hear people refer to it 7 sometimes as a road map. The contents of the -- table of 8 contents in a book is an analogy. The picture on a jigsaw 9 puzzle box, you know, this is what they're hoping the picture 10 will look like when they put all the pieces together. The 11 purpose of it is to help you understand from that person's 12 point of view what the case is all about so you'll have a 13 better chance of fitting the pieces together, as that person 14 wants you to, as they come in throughout the trial. 15 I will emphasize that the opening statement is not 16 evidence. Okay. It is what the lawyers anticipate or hope to 17 prove. Obviously, at the end of the case, one side or the 18 other picture on the jigsaw puzzle is not going to look like 19 they thought it was. Okay. So I emphasize the opening 20 statement is a very helpful tool for you. It will orient you 21 from each side's point of view as to what this case is going 22 to be all about, but it's not evidence. What we're going to 23 do is each side is going to be allowed up to two and a half 24 hours to make their opening statement. We will have the 25 plaintiffs' opening statement today, we will take a lunch 22 1 break, we will have the defendants' opening statement, and 2 then we will recess until Monday morning. So that's the plan 3 for today. People may or may not take breaks during their 4 opening statement. 5 Starting with Monday, the plaintiffs will call 6 the witnesses they wish to call and then each witness -- when 7 you hear me describe this, it's going to sound like they're 8 all equal pieces but, I tell you, the opening statement will 9 take a day, the evidence is going to take about six or seven 10 weeks, and then the closing part is going to take about a day, 11 so just because it takes me two minutes to explain each 12 section doesn't mean they're going to take the same length of 13 time to go through. The plaintiffs will call any witnesses 14 that they want to call and each witness that the plaintiff 15 calls, the defendant will get a chance to examine or 16 cross-examine that witness. After the plaintiff has called 17 all the witnesses they want to call, the defendant will call 18 additional witnesses. If they want to, each witness the 19 defendant calls the plaintiff will get to examine or 20 cross-examine that witness. That's pretty much the way it 21 proceeds on TV; one side calls the witness, they 22 cross-examine, and then the other side calls it. 23 Let me point out one thing about witnesses. No 24 one owns the evidence that a witness brings in, and just 25 because the plaintiff calls a witness or the defendant calls a 23 1 witness, doesn't mean that witness can't be helpful to the 2 other person's side of the case. I've had many cases by the 3 time the plaintiff gets through calling witnesses the 4 defendant doesn't call any witness because everybody that knew 5 anything about it has already testified. Do you understand 6 what I mean? And so just because the plaintiff calls somebody 7 or the defendant calls somebody, you don't put that witness, 8 well, in a certain category and say he or she can't help the 9 other side. All right. It may well be that some of the 10 plaintiffs' important evidence will come in through 11 defendant -- a witness the defendant calls and vice versa. 12 Some of the evidence very important to the defendant will come 13 in through a witness that the plaintiffs call. 14 After all the evidence is in, I will read you 15 some instructions or some rules of law you'll use to decide 16 the case. These will be in writing. They'll be given to you 17 to read while the trial -- you know, the final closing 18 argument, you'll be allowed to take them in writing back with 19 you to the jury room. You-all will also be allowed to take 20 any exhibits that are introduced back with you to the jury 21 room. 22 After that, each side will make a closing 23 argument. Again, this is a statement by the attorney of what 24 that attorney thinks you ought to decide or the side of the 25 case that that attorney represents. It's not evidence. It is 24 1 argument. After that, if there are still more than 12 of you, 2 your cars have started, your children have stayed healthy, 3 there will be a random draw to determine the alternate jurors. 4 At this point does anybody have any questions of me? We've 5 kind of put you in the box in alphabetical order, and I notice 6 that we've got an awfully big person in the middle row. Do 7 you think it might be good if I moved him to the back row and 8 asked one of the -- somebody on the back row to move up a 9 seat? Do you mind, sir? Who would like to move up? Okay. 10 Why don't you-all just swap seats there. That's the kind of 11 important question I could figure you-all sitting there 12 worried about; can we change seats in the jury box. And if 13 you want to make any other adjustments you can. Is there 14 anybody else that wants to -- anybody else in the back row 15 feel that they would like to move up a row or move one of 16 the... 17 JUROR WHITEHOUSE: I can see you fine. 18 JUDGE POTTER: Well, I'm not important. How 19 about over here? Can you see over there all right? 20 JUROR WHITEHOUSE: Yes. 21 JUDGE POTTER: Okay. Does anybody else have any 22 questions of me? Okay. We'll have opening statements. 23 Mr. Smith? 24 MR. SMITH: May it please the Court. 25 JUDGE POTTER: Mr. Smith. 25 1 MR. SMITH: Counsel. As Judge Potter told you, 2 this is the opportunity that the lawyers have to tell you what 3 they expect to prove in this case. This case involves a 4 complicated medication. This case involves a complicated 5 illness. This case involves complicated factual matters. I 6 first started working in connection with investigating the 7 facts surrounding this drug back in early 1991. As those 8 three years have progressed, I have spent more and more and 9 more time in connection with the investigation of this drug. 10 In those few years, Ms. Zettler and I have probably spent more 11 time with each other than we have with our respective spouses. 12 We've traveled from Boston to Florida, from Seattle to Chicago 13 and back to Texas. The evidence that we intend to present in 14 this case is going to be somewhat tedious, somewhat difficult 15 to follow at some times. What I'm going to try to do this 16 morning is briefly summarize and visit with you a little bit 17 about what we found in connection with our travels and our 18 time, in connection with this drug. You should know that this 19 drug is named Prozac. Prozac is a trade name. Prozac is 20 manufactured by Eli Lilly and Company. Eli Lilly and Company 21 is located in Indianapolis, Indiana. The chemical name for 22 Prozac is called fluoxetine hydrochloride. That's what you'll 23 see a lot of scientists refer Prozac to is fluoxetine 24 hydrochloride. Prozac is an antidepressant. Prozac doesn't 25 grow on trees; it's not extracted from berries; it's not 26 1 derived from animal products. Prozac is a synthesized drug. 2 It was specifically made in a laboratory. Prozac is a 3 powerful psychotropic medication. Prozac is an 4 antidepressant. Prozac's use on September 14th, 1989, was for 5 antidepressant treatment. Now, let me back up with you a 6 little bit and tell you what we've learned about depression. 7 Depression is a term that we laypeople and 8 physicians use that encompass a lot of things. We've all 9 gotten up and feel -- and felt like, you know, I feel a little 10 blue today. We've all had periods where we were sad. We've 11 all gone through periods of relationships with other people 12 that were rocky where we felt sad. We've all lost loved ones 13 where we felt sad. We've dealt with that, in most instances, 14 fortunately. These are periods of just feeling blue, just 15 down a little bit. Most of us have the ability, with time, to 16 get through this sad feeling. The depression that you're 17 going to hear about in this trial, the depression that Joseph 18 Wesbecker suffered from is far different. That depression is 19 called clinical depression or major depressive disorder. It 20 is a specific psychiatric term for a specific mental illness. 21 Major depressive disorder is a serious mental illness that 22 affects people. It affects some people dramatically. It 23 causes these people to lose their productivity. It causes 24 these people to lose their happiness. It's beyond the 25 ordinary "just feeling down." People who are clinically 27 1 depressed spend a lot of time in bed. People who are 2 clinically depressed have difficulty having fun, having 3 pleasure at anything. They can't bring themselves out of this 4 clinical depression, it seems like, regardless of what 5 happens. People could give them a lot of money. People could 6 change their circumstances, but it wouldn't change their 7 depression. I believe there are eight different symptoms of 8 depression to fit this psychiatric disorder and I believe the 9 psychiatrists say if you fit a certain number of these 10 symptoms, that you fall within this disorder. Depression is a 11 common illness treated by a number of psychiatrists. 12 Depression is also treated to some extent by general 13 practitioners, by people who -- doctors who have different 14 specialties. The fact is, though, that this is a significant 15 mental illness. People who suffer from major depression are 16 not weak; they're not lazy; they haven't lost their drive. 17 They are mentally ill. Scientists believe that the cause of 18 this type of depression may be a result of an imbalance of the 19 chemicals in our brain. Apparently, what we've learned, all 20 of our thoughts are really the result of chemical electrical 21 reactions in our brain. Our brain has many chemicals and is 22 made up of a bunch of nerves and a bunch of fibers, and 23 apparently these chemicals help in the transmission of these 24 thoughts from one nerve to the other. This is called 25 neurotransmission. It's extremely complicated. I don't 28 1 understand it and, believe me, you won't understand it when we 2 get completely finished, so don't feel bad about that. I 3 think you'll be able to learn a lot about it. I think the 4 scientists will tell you that there are many, many, many 5 unanswered questions in connection with neurochemistry, 6 neurobiology and the science of thought. 7 The neurotransmitters, that is, the specific 8 neurochemicals that aid in thought are -- there are several of 9 them, there's dopamine, norepinephrine, epinephrine and 10 serotonin. These chemicals act in different ways on different 11 parts of the brain. The neurotransmitter that we're going to 12 be talking about is serotonin. And I have some charts that 13 I'm going to show that -- to hopefully make it a little easier 14 to tell you what we're talking about. 15 I practiced my speech, but I didn't practice 16 unboxing the box. Now, can everybody see this? Anybody 17 having any difficulty seeing this? I can move -- no, I can't. 18 Can everybody see it, at least to some extent? 19 Serotonin is a chemical but there are specific 20 nerve cells in the brain that make this chemical, and there 21 are specific nerve cells in the brain that receive this 22 chemical. Apparently, the serotonin system goes almost 23 completely throughout the brain. This one neurotransmitter 24 transmitting thought, serotonin, only picks up particular 25 electrical nerve impulses. The point is -- it's difficult to 29 1 understand. The point is that this serotonin system 2 encompasses and affects an individual's entire brain. The 3 thought is that this clinical depression that we see so much 4 about, that we hear so much about that Joseph Wesbecker 5 suffered from is a result of an imbalance in the serotonin 6 system in depressed individuals' brains. The theory so far, 7 is that if the serotonin system, the serotonin level is 8 decreased, that mood will be decreased and you're more likely 9 to be depressed. If you increase the serotonin level, it 10 should increase your mood; therefore, make you less likely to 11 be depressed. It's as simple as that. The theory is, is that 12 depression is a result in many cases of the chemical imbalance 13 of serotonin. Specifically what the problem is, according to 14 the scientists, the serotonin level is too low. Again, I'm 15 just giving you a preview of the evidence. There's going to 16 be a lot of details here. 17 Now, serotonin just doesn't float around in our 18 brain, apparently. This serotonin has to act with nerves. 19 And what this chart depicts is what's called a presynaptic 20 nerve end and a postsynaptic nerve end. These little circles 21 with arrows marked "S" indicate serotonin. Now, remember, 22 there's other neurochemicals surrounding this, within this, 23 and around this, but this is just a depiction of serotonin 24 neurotransmission. Here's how it works and we'll have 25 experts, believe me, that hopefully will be able to explain it 30 1 in more clarity, but let me give you a preview of what I know 2 about it and what I expect the evidence to show. You have a 3 presynaptic nerve end and you have a postsynaptic nerve end. 4 There is in fact a space, an empty space, between the two 5 nerve ends of the two neurons. They're called neurons. And 6 the -- you've got -- it's like a bridge or a string or 7 something and you've got a gap there. And what you have is, 8 you have an electrical impulse with thought; thought being 9 transmited via electrical impulses that are picked up by these 10 serotonin cells. The serotonin cells then -- it's not cells. 11 The serotonin molecules are free here in this space, 12 absolutely free. The point is, is to get the thought from 13 this side to this side, and the way serotonin does it is by 14 traveling across -- the thought travels across here and it 15 falls into a receptor side. All right. Once the impulse gets 16 here, it connects and the molecule fires across. So you have 17 the serotonin impulse going across the serotonin synapse. 18 This is called the synaptic cleft, this open space. 19 What Prozac does, is it works right here on this 20 reuptake port. This is a constantly moving process. There's 21 more serotonin being produced and there's got to be some way 22 for the serotonin to be regulated, so this port right here is 23 reabsorbing serotonin, so it's trying to maintain the same 24 level. What Prozac does, it's a specific molecule that stops 25 it up right here. It stops the reuptake of serotonin. The 31 1 effect of that is to leave more serotonin in the synaptic 2 cleft because there is still being serotonin manufactured by 3 this presynaptic nerve. The thought is by increasing the 4 amount of available serotonin in this area that you're going 5 to increase neurotransmission; you're going to make the 6 serotonin system work better, more smoothly. Now, I know this 7 is difficult for me to explain, but the point is, is that 8 Prozac -- this has been -- remember, this is the theory that 9 depression is caused by there being a low serotonin level. 10 The theory is, is if you increase the amount of serotonin in 11 the synaptic cleft, then you will improve neurotransmission. 12 The way you do that is by stopping up the reuptake of it. 13 It's like you have a bucket and you've got a constant stream 14 in that bucket and you've got a hole in the bottom of the 15 bucket. There is a smaller hole at the end, so you've always 16 got a level of liquid in that bucket, but if you stop up the 17 hole and have the same amount of fluid coming in, you're going 18 to increase the level, or if you reduce that hole you're going 19 to increase the level of serotonin; the theory being if you 20 increase the level of serotonin you increase mood. 21 The problem with this is, is that no one knows 22 exactly what anybody's serotonin level is. It can't be 23 measured. We can't go into a doctor's office and get a 24 serotonin level of our brain chemistry. We can go in and get 25 a serotonin level of our blood chemistry, but that won't do 32 1 any good because the important factor is how much serotonin 2 there is in the synaptic cleft. This is a microscopic detail 3 that you see. It can't be determined at all what the 4 serotonin level is of an individual. The theory that 5 decreased mood is a result of decreased serotonin is just 6 that, a theory. You can't measure directly what an 7 individual's serotonin level is at their synaptic cleft. What 8 we do know is that it varies, probably all 16 of you, as you 9 sit here today, have a different serotonin level right now; in 10 other words, not a one of you that has the same serotonin 11 level. The fact is, when you walked in and you sat down, you 12 each probably had a different serotonin level when you came 13 in. Your level of serotonin is fluctuating daily, and my 14 level of serotonin isn't the same as yours, and my level may 15 not be the same tonight when I go to bed, but the theory is 16 that you can generally increase the level of serotonin. You 17 can generally increase mood. Again, that's a theory. 18 With this theory in mind that if you could 19 increase serotonin levels you could reduce depression, the 20 Lilly scientists set out to invent a chemical that would 21 increase serotonin, and they invented Prozac. As I said, 22 Prozac is not something that occurs naturally; it is a 23 synthetic, synthesized medication. It was physically invented 24 and developed in the Lilly laboratories in Indianapolis, 25 Indiana, two and a half hours up Interstate 65. After the 33 1 Lilly scientists invented Prozac, the first thing they did was 2 get a patent on it. It is an invention that was patentable, 3 it was a peculiar product and they got a patent on it to make 4 sure it was theirs. Prozac was invented by the Lilly 5 scientists for Lilly to sell to the public to treat 6 depression. The goal from the outset by Lilly in developing 7 this product was to sell it for treatment of their depression. 8 It was invented back in the '70s, it was developed in the late 9 '70s. The clinical trials occurred in the late '70s and early 10 '80s. 11 Remember, throughout this case, that the theory, 12 the basis for how Prozac works is in fact a theory. It's 13 never been proven conclusively that increasing the level of 14 serotonin will improve mood. 15 When Lilly got the patent on Prozac, fluoxetine 16 hydrochloride, that meant nobody else could do anything with 17 it; it was their product. But being their product didn't do 18 them any good. In order to justify their product, they had to 19 be able to sell it. In order to sell it, they had to get Food 20 and Drug Administration approval. What the Food and Drug 21 Administration requires is that they test it. This is what's 22 called the clinical trials, the testing phase of Prozac. 23 I believed when I started this case that FDA 24 approval meant that a drug had been tested by the Food and 25 Drug Administration in Washington. I believed that physically 34 1 the FDA in Washington took that product, put it under a 2 microscope, did whatever they do with it and tested it. I 3 believed that they had actually gotten their scientists, their 4 doctors, their chemists and their people, the FDA people to do 5 the testing on this drug. I bet that you aren't any different 6 than me in your belief that I started out with, that the FDA 7 actually tested this drug. That's not true. The FDA itself 8 doesn't test pharmaceutical products in this country. The FDA 9 didn't test Prozac. Food and Drug Administration didn't test 10 Prozac, the National Institute of Mental Health didn't test 11 Prozac. The Centers for Disease Control didn't test Prozac. 12 Eli Lilly and Company tested Prozac. The inventor of the 13 drug, the proponent of the application for food and drug 14 approval tested the drug. What I mean by that is that Lilly 15 invented the drug, Lilly designed the test that would be 16 performed on the drug. Lilly chose the investigators who 17 would test the drug. Lilly chose the sites where the drug 18 would be tested. Lilly set up the rules and guidelines for 19 what people could be included in the test. The tests were 20 conducted exclusively by Eli Lilly. The trial process was 21 done by Lilly at their guidance, direction and control. 22 The first thing they did was they gave the 23 product to animals. They just injected Prozac into rats and 24 mice and monkeys and things of that nature. They did tests on 25 them. But Lilly did that in their animal laboratories in 35 1 Indianapolis, Indiana. The Food and Drug Administration 2 didn't do that. Lilly then reported that data to the FDA in 3 Washington, but remember, the FDA didn't kill any rats. These 4 were all Lilly rats that died in the clinical trial, clinical 5 trial process on animals. 6 When the human trials started, what Lilly did first was give 7 that medication, Prozac, fluoxetine hydrochloride to normal, 8 healthy humans. But they did that in their clinic in 9 Indianapolis, Indiana; the Food and Drug Administration 10 doctors didn't give Prozac to people in Washington. It wasn't 11 given at the Centers for Disease Control in Atlanta. It 12 wasn't given at the National Institute of Mental Health in 13 Bethesda, Maryland. The normal human trials were performed by 14 Eli Lilly on people under Eli's control by people under Eli 15 Lilly's control. Then that data was reported to the Food and 16 Drug Administration in Washington. 17 After the drug was given to human subjects who 18 weren't depressed, the drug was given to individuals that were 19 depressed. That wasn't done in Washington, D.C. First of 20 all, Eli Lilly and Company designed those tests. They're 21 called protocols. And what they are is they're a guideline of 22 how to do the test. But that was done, those protocols were 23 drawn up in Indianapolis, Indiana. That's not something 24 that's prescribed by the Food and Drug Administration. Once 25 the protocols or guidelines were drawn up, Eli Lilly and 36 1 Company went out and hired investigators to administer these 2 tests and they hired people, psychiatrists over the country, 3 and they chose them because they had been involved in other 4 clinical trials for Eli Lilly and for other pharmaceutical 5 manufacturers, and because they had a particular expertise in 6 testing psychotropic medication. They paid those 7 investigators and they paid them based on the number of 8 patients that they enrolled in the studies. They gave to the 9 investigators the rules of the test. 10 Those rules of the clinical trials prescribed 11 who could be in the test and who could not be in the test. 12 They prescribed how the test was to be done and what scales 13 were to be used. Obviously, they were testing the drug to see 14 whether or not it had any effect in treating depression. So 15 what they do is they administer a lot of scales. You'll hear 16 stuff like the Hamilton Depression Rating Scale. You'll hear 17 Ham and Ham D and Ham D3. They administered the Clinical 18 Global Impression, so you'll hear CGI. You'll be masters of 19 these terms by the time we finish. The point is is those 20 scales, what scales they used were prescribed by Lilly. The 21 investigators didn't have any discretion, then, in how to test 22 the people. 23 The investigators were given case report forms 24 to fill out on these patients. These case report forms were 25 filled out by the investigator or their assistants, but those 37 1 investigators didn't send those case report forms to 2 Washington to the Food and Drug Administration; those 3 investigators sent those case report forms to the people that 4 were paying them, Eli Lilly and Company in Indianapolis, 5 Indiana. Then when those case report forms came to Lilly in 6 Indianapolis, that data was put on computers and that data was 7 defined and categorized in many different ways and was 8 summarized and was capsulized and was crystallized and was 9 compartmentalized. Then Lilly sent data to the FDA, but the 10 data that Lilly sent to the FDA was their summaries, their 11 capsulizations and their crystallizations of what the results 12 of the clinical trial were. Lilly will tell you in this case, 13 "Oh, we submitted to the Food and Drug Administration all the 14 data we had on Prozac, fluoxetine hydrochloride. They didn't. 15 They did not. But they're going to say we sent every case 16 report form that we had to them. What they did is they put it 17 in a microfiche and sent it off to Washington. Well, the FDA 18 and many other governmental agencies are understaffed, 19 underpaid and overworked. Believe me, the Lilly scientists 20 themselves will tell you that the FDA relied not on the 21 individual case report forms but simply on the summaries and 22 the characterizations of that data that were sent in by Eli 23 Lilly. 24 The fact of the matter, ladies and gentlemen, 25 is, is that we are at the mercy; Joseph Wesbecker was at their 38 1 mercy and these plaintiffs in this case all are at the mercy 2 of the inventor and the seller of the drug that tests the 3 drug. You're going to be able to make your own 4 characterization and your own impression as to whether or not 5 that's good or bad or not, but the clear truth of the matter 6 is we're all at the mercy of people that invented the drug and 7 the people that are going to profit from the drug, and with 8 Prozac it was Eli Lilly and Company. 9 The first that Lilly did in connection with 10 these clinical trials was they gave the drug to animals in the 11 late '70s. When they gave the drug to cats back in the late 12 '70s -- this is the early clinical trials, they found that 13 that drug was interfering with REM sleep, R-E-M, rapid eye 14 movement. That apparently is a significant type of sleep that 15 we all need to stay mentally stable. Psychotropic medication 16 was affecting the brains of cats. It was interfering with 17 their REM sleep. We'll show you the scientific paper. We'll 18 read to you from the scientists about when they gave Prozac to 19 the cats in pretty healthy doses, healthy cats, they found 20 that those cats that had otherwise been friends, started 21 growling, hissing and fighting. They actually reported that 22 in a scientific paper. Lilly didn't tell the Food and Drug 23 Administration that this had happened. 24 The first few clinical trials didn't show that 25 Prozac was any good in treating depression. In fact, it 39 1 indicated that it was not good at treating depression because 2 it was, in some people, making them agitated, nervous, 3 irritable and psychotic. In 1978, the clinical trials on 4 Prozac were stopped, discontinued because Prozac couldn't be 5 found to be effective -- it's called efficacious and because 6 the side-effect profile on Prozac was pretty scary. But the 7 supervisor that stopped the clinical trials was overridden by 8 the inventors of the drug. They went to the supervisor's 9 boss. They went to a vice-president, and they said, "Give us 10 one more chance to prove that this drug works." And so they 11 decided that what they would do is that they would give Prozac 12 one more year. And what they did is they assigned Prozac to a 13 gentleman who had one year left before retirement, and they 14 said, "During your last year, we want you to run some trials 15 to see simply if Prozac works. You're limited to looking at 16 one thing. Can you prove that Prozac is efficacious." 17 The results of Doctor Slater's testing was 18 borderline at best. There was very minimal efficacy shown, 19 but the agitation, anxiety, nervousness, psychotic profile of 20 the drug was still recognized. Doctor Slater indicated that 21 20 milligrams was worthless and that people were going off the 22 wall at 60 milligrams. Doctor Slater indicated that maybe 23 there ought to be some combination of this drug with some 24 other drug that would reduce this agitating factor that this 25 drug produced. The problem with that is, is that these people 40 1 that invented the drug, Doctor Fuller, Doctor Wahl, who were 2 proud of the drug because this was something they had 3 synthesized and it was important to them because it only 4 worked in the serotonin system. It purportedly didn't work on 5 any other parts of neurotransmission. It didn't affect 6 dopamine. It didn't affect epinephrine. It didn't affect 7 norepinephrine. It was a pure drug. They didn't want to 8 contaminate this drug with any other type of medication that 9 would reduce the dangerous property of this drug that was 10 emerging. 11 Nobody at Lilly told the Food and Drug 12 Administration that this drug was beginning to present this 13 profile. Nobody at Lilly told the FDA that the product was 14 worthless at 20 milligrams and that people were going up the 15 walls on 60 milligrams. Nobody told Lilly -- told the FDA 16 that the Lilly clinical trials had been canceled. 17 Early on, back in '79 and '80, after this 18 problem began to arise, the Lilly scientists decided what they 19 better do is do something about this problem. So they did 20 something about this problem in a few ways: They directed the 21 course of the clinical trials so that they could get a 22 favorable outcome so they could sell the medication. The die 23 was cast by Lilly themselves. Number One, what they did to 24 control the result of the clinical trials was to design the 25 trials in such a way that they would exclude individuals with 41 1 serious suicidal risk. In other words, they took a depressed 2 population and they reduced it automatically, and they reduced 3 those people in the clinical trials who were probably the most 4 depressed, those people with serious suicidal risk. 5 In excluding those individuals with serious 6 suicidal risk, they certainly excluded a significant body of 7 information concerning the safety and efficacy of this drug. 8 Because Lilly themselves are going to get up and say it's 9 important to understand that suicidality is a real significant 10 factor in depressed individuals. And then they say, well, our 11 clinical trials didn't show any increase in suicidality. The 12 reason they didn't is because they excluded them. 13 Secondly, the way they directed the clinical 14 trials in their favor was somehow, some way, to give Prozac to 15 individuals who were less depressed than people on placebo or 16 people on comparative drugs. How they did this, we don't 17 know. We didn't learn this until we had our statistician look 18 at the statistics from the baseline scores on these tests. 19 And he looked at the people that started out the test and 20 found that the people that started out the test had lower 21 baseline scores than the people on Prozac and the people on -- 22 the people on Prozac had lower baseline scores than the people 23 on placebo, which is no drug, or comparative drug which is 24 another kind of existing antidepressant. Somehow it ended up, 25 whether it was by chance or by purpose, that the people who 42 1 were taking Prozac in the clinical trials weren't as sick as 2 the people with whom Prozac was being compared. 3 Thirdly, and probably most significantly in 4 connection with what happened to these people and their loved 5 ones is, is that Lilly allowed their clinical investigators to 6 administer what's called contaminant medication. That means 7 that if you're in a test on a clinical trial and you're being 8 given Prozac, that you can get another medicine along with 9 your treatment. What occurred was that the people in the 10 Prozac clinical trials got sedatives. They got sedatives 11 because Prozac causes insomnia in a number of people. You 12 know what else the people in the Prozac clinical trials got? 13 They got tranquilizers because Prozac was making them 14 agitated. In effect, what you had in the Prozac clinical 15 trials were not clinical trials of Prozac at all, but clinical 16 trials of Prozac in combination with sleeping pills and 17 tranquilizers. You're going to hear the terms chlorhydrate 18 and benzodiazepines in this lawsuit. Those are -- 19 chlorhydrate is a sleeping pill and benzodiazepines are 20 tranquilizers, like Valium. They're psychotropic medications. 21 Chlorhydrates are called hypnotics; benzodiazepines are called 22 anti-anxiety agents, tranquilizers. So when the Prozac was 23 making the people in the clinical trial nervous or jumpy or 24 anxious or when the Prozac in the clinical trial population 25 was causing the people not to be able to sleep, the 43 1 investigators were giving the clinical trial subjects 2 medication. And so what you found was these other medications 3 reduced the insomnia and reduced the anxiety, agitation, 4 nervousness, irritability because they were getting 5 tranquilizers, and you had people whom were actually being 6 tested on two medications. 7 Well, the FDA got wind of that, and they wanted 8 some kind of report as to how much psychotropic medication was 9 being given to the clinical trial subjects, and they finally 10 got it after some time out of Lilly, but that data is 11 relatively obscure and relatively incomplete. But what you're 12 going to find is that a significant number of people in the 13 Prozac clinical trial didn't get just Prozac. They got other 14 drugs that were affecting their behavior, and Prozac, 15 remember, is supposed to affect your behavior. 16 Now, let me step aside a second and talk to you 17 a little bit about something else, another line of evidence 18 that you're going to be seeing in this case; that's suicide 19 and attempted suicide. Well, Joseph Wesbecker, after he shot 20 and murdered these people, committed suicide himself, but our 21 claim in this case isn't that Prozac caused Joseph Wesbecker 22 to just commit suicide; our claim here is that Prozac caused 23 Joseph Wesbecker to injure them. It caused violent, 24 aggressive, homicidal behavior. 25 I thought when I started this lawsuit that you 44 1 shouldn't be able to get any information about whether or not 2 Prozac caused Joseph Wesbecker to shoot somebody by looking at 3 information as to whether or not Prozac causes somebody to be 4 suicidal, but apparently that's not the case. Apparently, the 5 concept of suicide, attempted suicide and violent, aggressive, 6 homicidal behavior are all linked, and apparently the question 7 is violence. And it doesn't make any difference whether that 8 violence is outward directed, which would be violence toward 9 others, or inward directed, which would be suicide. 10 Complicated. 11 You think, well, if I'm mad at somebody that 12 doesn't necessarily mean I'm going to commit suicide, or if I 13 commit suicide that doesn't necessarily mean that I'm likely 14 to go out and shoot somebody else. But the psychologists -- 15 all of the psychologists, even the Lilly psychologists, say it 16 comes from the same biological marker, a biological marker of 17 violence, aggressive behavior. Guess what biological marker. 18 Take a guess at what biological marker is associated with 19 suicide and violent behavior. You guessed it. Serotonin. 20 Lilly said -- Lilly says that the scientific data is that by 21 taking Prozac you increase your serotonin and, therefore, 22 you'd be less likely to attempt suicide, you'd be less likely 23 to become violent and aggressive. Remember, the theory is 24 only a theory. What in effect occurs is that when you stop 25 this port up, when you prevent reuptake, you get a flood of 45 1 serotonin. It's like stopping the hole in a bucket and you 2 still got the faucet running in. Something's got to give. 3 That is a real crude example, believe me, but it's basically 4 the same thing. 5 What happens, we think, in part is when there 6 gets a lot of serotonin in here, it messes the system up. It 7 messes the system up because reuptake is plugged up. When 8 there gets to be a lot of serotonin in, this postsynaptic 9 neuron has to do something. What it has to do is make these 10 receptor sites here less sensitive. It dulls them. Also what 11 it does is it makes these sites that make the serotonin shut 12 down. They quit making serotonin because they sense there's 13 an increased level of serotonin in this synaptic cleft. So 14 you start getting, we think, and Lilly agrees, a lot of 15 compensatory mechanisms here. But, remember, nobody has ever 16 been able to measure it at the synaptic cleft. Nobody knows 17 what it is to start with. The only evidence Lilly had to 18 submit to the Food and Drug Administration as to whether or 19 not the theory worked, Number One, and whether or not by doing 20 that increased the serotonin you might have a bad effect 21 instead of a good effect was the clinical trials. And that's 22 why you're going to hear a lot about these clinical trials 23 because the clinical trials didn't accurately present the 24 dangers and safety of Prozac, and what happened in the 25 clinical trials is that this danger for Joseph Wesbecker was 46 1 obscured by virtue of the design, implementation and reporting 2 of the clinical trials to the Food and Drug Administration. 3 The reason Joseph Wesbecker did what he did, in part, in part, 4 was because Eli Lilly didn't accurately design the trial, 5 conduct the trials and report the data that they learned in 6 the trials to the FDA. I'm out of breath. I think I've been 7 going how long, Your Honor? 8 JUDGE POTTER: Approximately an hour. You want 9 to take a break? 10 MR. SMITH: You-all want to take a quick break? 11 JUDGE POTTER: Ladies and gentlemen, I hope you 12 can all hear me; not too many of you can see me. What we're 13 going to do is take a 15-minute recess. As I've mentioned to 14 you-all before, do not permit anybody to speak to you on any 15 topic connected with this trial and any attempt to do so 16 should be reported to me. Do not express opinions on this 17 case or form any opinions about it until it is finally 18 submitted for your determination. With that admonition we'll 19 stand in recess for 15 minutes. 20 (RECESS) 21 JUDGE POTTER: Mr. Smith, I hope we've done a 22 little better with the microphones there. If we haven't and 23 you want to take a stop and try and work on it, please feel 24 free to do so. 25 JUDGE POTTER: If there's anybody in the jury 47 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 47 1 there that can't hear Mr. Smith -- I know lawyers raise and 2 lower their voices for effect, but if he does that and you 3 can't hear him, the effect isn't doing any good. 4 MR. SMITH: Have you-all been able to hear me 5 all right? Otherwise, I'll just repeat what I said. I'm 6 going to try and move a little quicker because I, believe it 7 or not, have a lot more to say about this drug and what its 8 effect on Joseph Wesbecker was. 9 I want to go back with you to the clinical 10 trials. By the early 1980s the Lilly trials were in full 11 progress. They had clinical trials going in multiple sites 12 all over the country and they were getting clinical trial 13 report forms in. They were designing more and more trials 14 with more and more guidelines. They were still excluding 15 serious suicidal risk of patients in the clinical trials. 16 They were still administering psychotropic tranquilizers and 17 sleeping pills to get rid of this stimulating, activating 18 effect that was being seen with Prozac. But by September 19 1983, Lilly had collected what they thought was enough support 20 and enough data to warrant approval by the Food and Drug 21 Administration of Prozac; in other words, they thought they 22 had enough proof of safety and efficacy to get FDA approval of 23 the product, and so they submitted what's called an NDA. Up 24 to that time they had been operating under an IND. A lot of 25 initials, but IND simply means that they were investigating 48 1 the drug; NDA means that they were continuing to investigate 2 the drug but they thought they had enough data to support the 3 safety and the efficacy of the product. 4 In the NDA -- and NDA is one document with 5 thousands of documents behind it, but the first page of that 6 document says -- I want you to remember this throughout this 7 trial. The first page of that document is Lilly's promise and 8 warranty and guaranty that the data they're submitting to the 9 Food and Drug Administration is all the scientific data that 10 there is, pro or con, good or bad or indifferent, regarding 11 what the scientific knowledge of the product is and how it 12 affects human beings, because the product now is being treated 13 and being used for the people that need it, depressed people. 14 Remember, Lilly has promised to the Food and Drug 15 Administration and to you and me and everybody that by 1983 16 this is all the science, all the data, good or bad, pro or 17 con, in connection with this product. That promise is a 18 continuing promise that they will continue to give them 19 documents and information and science on this drug. 20 By submitting the NDA you don't get overnight 21 approval from the FDA. The FDA begins a review process. 22 Remember, it's a review process. You've got thousands of 23 people in the clinical trials, according to Lilly. You've got 24 hundreds of investigators, hundreds of Lilly employees working 25 on the product, and you've got millions of Lilly dollars in 49 1 the product, and they're continuing to spend more money at 2 this time on the product, but they hadn't made a dime off the 3 product. 4 By September 1983, all the data that they had 5 collected from the different investigator sites wasn't really 6 too good. If you look at the data individually, what it 7 showed was that it wasn't any better than other existing 8 antidepressants. If you looked at the data individually, many 9 of those trials showed that Prozac wasn't any better, wasn't 10 as good as existing antidepressants. The only way Lilly could 11 get data that they wanted to support efficacy was by pooling 12 all of their data and using the raw numbers together. 13 We don't live in the only country in the world. 14 And there's not a market -- this is not the only market in the 15 world for an antidepressant. People are suffering from 16 depression worldwide. So Lilly made application for the 17 approval process in countries throughout the world, including 18 Europe. So they submitted this same data, same data that they 19 submitted to the FDA to a lot of other governments. They 20 submitted it to Germany; they submitted it to Italy; they 21 submitted it to France; they submitted it to Spain. What 22 those governments did was the same thing the FDA did; they 23 were looking for efficacy and safety of the drug. Now, they 24 looked at it in several different ways, but the final analysis 25 is, is this drug safe. Lilly felt like they needed to sell 50 1 this drug worldwide. Lilly saw a potential for this drug 2 worldwide, so they submitted applications and let other 3 governments review this data that they submitted to the Food 4 and Drug Administration. Big mistake. Big mistake for Lilly. 5 The governmental authority in Germany that's 6 charged with making sure products are safe for German citizens 7 is called the BGA. When the BGA looked at this data they saw 8 some real problems with this drug. The BGA has a different 9 review process from the FDA. The BGA has the governmental 10 body itself that approves the product, but they also have 11 what's called a Commission A. What the Commission A is, is a 12 group of independent scientists that review the safety and 13 efficacy of this drug, along with the BGA. So back in 1984, 14 they had -- the BGA had finished their review of this product. 15 Same data, remember; same controlled Lilly clinical trial data 16 that the FDA had seen. Look what they found. 17 This is a document. This is an interoffice 18 Lilly document. This first page says, "Yesterday we 19 unofficially received a copy of the medical comment on 20 fluoxetine application. A translation is attached." 21 Remember, fluoxetine is the chemical name for Prozac. This 22 letter was sent to the Lilly employees in Indianapolis, to 23 Lilly employees throughout the country, and to Doctor Leigh 24 Thompson in Indianapolis, this man sitting right here at the 25 end of this table. It was sent May 25th, 1984. Here's what 51 1 it says. This is what the German government is saying about 2 their review of this data. This is their comment on the 3 clinical documentation. 4 Number One, it says, "In the studies, up to 17 5 criteria for exclusion were stated." In other words, these 6 rules about who could be in the trials and who couldn't be in 7 the trials, there were 17 different criteria for exclusions. 8 "Of the 46 attached study protocols, in 25, the note is to be 9 found that these studies are not completed." This is the same 10 data that the FDA got. "The comparison studies with standard 11 antidepressants and with placebo gave most variable results. 12 In three studies, the preparation showed no efficacy; in 13 others, it was equally effective. Only in the Imipramine 14 study, the preparation showed itself to be more effective in 15 individuals of the studied parameters." Not too good a report 16 about the efficacy of this drug. 17 Now look what they say: "The frequency of side 18 effects was very high, partly more than 90 percent, and the 19 side effects resulted nearly in each study in dropouts. The 20 frequency of side effects depended on the dose, the age and 21 the duration of therapy. Deciding for the clinical 22 significance of side effects is not only the frequency of 23 their occurrence but of their safety. In 15 to 20 percent of 24 the cases, side effects occur which involve the central 25 nervous system," that's the brain and the nerves. "As most of 52 1 them vary, assemble the clinical picture from underlying 2 disease. Even from theoretic aspects one has to expect an 3 intensification and not an improvement of symptoms." In other 4 words, the side effects were getting worse. 5 Summarizing the opinion, "Considering the 6 benefit and the risk, we think this preparation totally 7 unsuitable for the treatment of depression." Totally 8 unsuitable for the treatment of depression. May 1984. That's 9 the medical comment from the German regulatory authority. 10 Side effect profile, 90 percent. Do you know when the Food 11 and Drug Administration learned of this? Never was it said to 12 them in that form. You know when it was sent? It was sent 13 over two and a half years later to the FDA only in summary 14 form. 15 What else did the German government have to say 16 about this? Well, in fact, the German government told Lilly 17 that they were going to reject the product and that you either 18 get your application withdrawn or get us some more data. Here 19 is the official correspondence from the German government. 20 This is the official intent-to-reject letter 21 from the BGA. "The drugs concerned are not sufficiently 22 tested to the secure state of scientific knowledge, and the 23 therapeutic efficacy which is claimed for them is 24 insufficiently substantiated. The promoted studies do not 25 allow a judgment on the efficacy and safety in long-term use. 53 1 For the drug's concern, there is, according to their specific 2 profile of adverse effects, the justified suspicion that they 3 have unacceptable damaging effects. The use of the 4 preparation seems objectionable, as the increase in agitating 5 effect occurs earlier than the mood-elevating effect and, 6 therefore, an increased risk of suicide. During treatment 7 with the drug, some symptoms of the underlying disease, 8 anxiety, insomnia, agitation increase, which, as adverse 9 effects, exceed those which are considered acceptable by 10 medical standards. We give you a chance to correct this or 11 your product is not going to be approved." 12 You know when Lilly told the Food and Drug 13 Administration, even though they learned it in September '83, 14 that they would make them aware of the scientific state of the 15 knowledge of this drug? They told them in October 1987, years 16 later. And when they told them, they obscured it, summarized 17 it, and hid it. It was too late. 18 When it became apparent that Lilly wasn't going 19 to get approval in Germany without some serious help, they 20 called in the scientific cavalry in Germany; they didn't help 21 them. And they said, their experts, their own experts told 22 them that the suicide rate was way too high; that this product 23 was creating activation and agitation and that this 24 side-effect profile of increased suicide would continue to 25 exist. And it lingered and lingered and lingered in Germany. 54 1 Apparently, Lilly sent volumes of information to 2 Germany to try to correct this problem. Apparently, they did 3 more studies to try to correct this problem. It didn't help. 4 The only way Lilly could get approval of Prozac in Germany was 5 to use the drug, recommend use of the drug in the package 6 insert in a way differently than it is here. The only way the 7 German government lets Prozac be sold in Germany is by a 8 warning in the package insert concerning these particular 9 risks and hazards. 10 On December 6, 1989, when this product was 11 already been approved in the United States, it was still under 12 consideration in Germany. On December 6, 1989, when a lot of 13 these people were still in the hospital, when a lot of these 14 people were still in the process of terminating their loved 15 one's estate, Prozac hadn't been approved in Germany. When 16 Joseph Wesbecker killed and maimed these people, Prozac wasn't 17 allowed to be prescribed in Germany at all. 18 Here's what the proposed package insert said in 19 Germany that was under application at the time concerning 20 people with Joseph Wesbecker's risk. It says, "Fluoxetine. 21 Does not act generally sedating. Until the 22 onset of depressive-alleviating effect, the patients have to 23 be observed adequately. In patients with suicidal risk, 24 continuous observation and/or a generally-sedating additional 25 therapy may be necessary. In patients suffering from 55 1 agitation or marked sleep disturbance, fluoxetine has to be 2 used with special care." 3 Let me read that to you again, because I can't 4 read that very well, and I think it's significant to know what 5 Lilly was recommending to the German government. This is a 6 Lilly document. This is not a German government document; 7 this is what Lilly proposed that the people of Germany know 8 about this product. I'm going to read it again because this 9 is December 6, 1989, two, almost three months after what 10 happened here in Louisville happened. "Fluoxetine does not 11 act generally sedating. Until the onset of depression- 12 alleviating effect, the patients have to be observed 13 adequately. In patients with suicidal risk, continuous 14 observation and/or a generally sedating additional therapy can 15 be necessary. In patients suffering from agitation or marked 16 sleep disturbances, fluoxetine has to be used with special 17 care." 18 This is what doctors in the United States got 19 and get (indicating). Not a word. Doctor Lee Coleman, 20 psychiatrist here in Prozac -- psychiatrist here in 21 Louisville, never got that information. Doctor Lee Coleman 22 never got this final -- this is what finally appeared in the 23 Prozac -- Fluctin -- it's called Fluctin in Germany. Prozac. 24 Fluoxetine hydrochloride, Fluctin. It's called Fluctin in 25 Germany. This is what the German people are told about this 56 1 product; this is what you're not told about this product. 2 Risk of suicide. Fluctin does not have a general sedative 3 effect on the central nervous system; therefore, for his or 4 her own safety the patient must be sufficiently observed until 5 the antidepressant effect of Fluctin kicks in. This also 6 applies in cases of extreme sleep disturbances or 7 excitability. Ask yourself in this case why don't the people 8 in Louisville, Kentucky, get the same information that people 9 in Bonn, Hamburg or Berlin, Germany, get concerning the risk 10 of this drug. Ask yourself that throughout this case. 11 You want to hear something else? You want to 12 see something else concerning what was going on with Lilly 13 concerning this drug? This is back in 1984. 1984 is when the 14 BGA sent that original letter out saying here's our list of 15 concerns, here's our intent to reject. What Lilly did was 16 they did this two-volume, four-volume study and sent it to 17 them, and here's a draft of the reply to the medical opinion 18 within the list of concerns, 1984. This was done not part by 19 the FDA, not by the BGA, but by Lilly scientists in Germany. 20 You know what they said about this problem that was raised in 21 the list of concerns, this increased agitating effect, the 22 problem of increased suicide? You know what they said about 23 it? Lilly's own people were telling Germany. They said if 24 the drug is used according to the revised package literature, 25 that's in agitated and suicidal patients only, together with 57 1 concomitant sedative drugs, there should be no doubt of 2 fluoxetine positive benefit/risk ratio in the treatment of 3 depression. Lilly's own people. Lilly's own people. This is 4 a Lilly document, confidential, own people saying if the drug 5 is used according to the package insert with concomitant 6 sedatives it will be safe, only together with concomitant 7 sedative drugs. You know when Eli Lilly and Company told the 8 Food and Drug Administration that they had made this 9 recommendation for use of Prozac in Germany? Do you know when 10 they told them that they had said this about this risk with 11 this drug? They still haven't. You've heard it, but the FDA 12 hasn't heard it. 13 In effect, what you have is Lilly applying two 14 different standards to two different countries. 15 Unfortunately, for you and I and most unfortunately for these 16 people in these first four rows, we're the ones who get the 17 short end of that study. Lilly says, well, you know, these 18 people are depressed. We did that because that's the only way 19 we could get it marketed there. That's simply a regulatory 20 matter. You don't have to worry about that regulatory matter 21 in foreign countries. We have the chairman of the board of 22 Eli Lilly and Company on videotape, a videotaped deposition, 23 and he'll tell you, you view him and you see what his attitude 24 is concerning this product. It's simply a foreign regulatory 25 problem. Is it a foreign regulatory problem? If that were 58 1 the end of it that would be bad enough, but we've got more 2 evidence concerning the danger of this drug. Fortunately, 3 since the FDA itself doesn't independently test the drug; 4 fortunately, since the FDA relies on the manufacturer of the 5 drug to test the drug and report to them the test of the drug, 6 they want some information about what happens to the drug 7 after the drug goes to market. This is called postmarketing 8 experience data. 9 The reason for this postmarketing experience 10 data is simple. The clinical trial data is very limited 11 because you're just studying, Number One, a limited amount of 12 people and, Number Two, it's given during the clinical trials 13 under controlled regulatory regulated circumstances; that is, 14 Lilly has selected only certain people. Once you start 15 selling the product to the public, you're going to be exposing 16 the product to many more people. You're going to get a great 17 wider variety and a broader data base of the experience with 18 the drug. So if something comes up with the drug, the FDA can 19 monitor it, and they do this by means of some regulations. 20 You can file, any doctor, anybody can file with 21 the FDA an adverse experience report. It's called a 1639. 22 The doctors aren't required to do this, but Lilly is required 23 to, if they learn of an adverse experience with a drug, report 24 it to the FDA. Lilly keeps their own computer data base 25 concerning adverse experiences with a drug. That's called the 59 1 DEN system; Drug Experience Network. But the FDA's data base 2 system is called the SRS system. Do the clinical trials, does 3 FDA approval, even according to the FDA, mean that Prozac is 4 safe? Let me tell you what the FDA says about that. This is 5 an FDA document: "When a drug goes to market, we know 6 everything about its safety. Wrong. Call 1-800-FDA." 7 The FDA is telling you two things here. They're 8 telling you, Number One, simply our approval of the drug 9 doesn't mean the drug is safe and, Number Two, we want to know 10 about adverse experiences in connection with this drug. Well, 11 there's more information. More information. 12 There has -- this product's been on the market 13 since 1987 in this country, so there is a data base concerning 14 this drug. Lilly scientists categorize the agitation syndrome 15 and the potential of this drug to cause problems, and they 16 categorized it in several different ways. I'll read these off 17 in connection with -- we have the computer data base. You can 18 write the Food and Drug Administration, make a request and get 19 information about it through a computer, the experience of the 20 drug. This is through July 1993. This is computer printouts 21 of adverse experiences in connection with this drug that are 22 related to the problems of Joseph Wesbecker, violence towards 23 self, suicide, attempted suicide. 24 Depression with suicidal ideation, 933 cases; 25 psychotic depression, 114 cases; Overdose, 897 cases; suicide 60 1 attempts, 1,889 reports, in black and white, hard computer 2 data. Through July 1993, there were a total of 4,830 reports 3 of self-directed violence in connection with this drug. Now, 4 other directed violence, what are the numbers on that? 5 Here's subjects that Lilly scientists agree is 6 what you look at. Here's the event turns you look at in that. 7 Aggravation reaction, 745; acute brain syndrome, 44; 8 agitation, 1,035; CNS stimulation, 49; confusion, 492; 9 delirium, 98; delusion, 71; depersonalization, 125; emotional 10 lability, 206; hostility -- hostility, 664 reports of 11 hostility on this drug; manic reaction, 477; manic depressive 12 reaction, 25; paranoid reaction, 139; personality disorder, 13 430; psychosis, 226; schizophrenic reaction, 16; thinking 14 abnormally, 497; irritability, 940; intentional injury, 373; 15 death, just the category of death, 120; abnormal dreams, 344; 16 insomnia, 1,073. These are categories Lilly scientists agree 17 are applicable to looking at this issue as to whether or not 18 Prozac causes violent aggressive behavior; anxiety, 928. 19 Total outward directed signs of violence, 7,177, along with 20 the eight or nine thousand of inward directed violence. 21 Shocking. Shocking. 22 Prozac is given to a lot of people. Shocking. 23 You know what else? The FDA literature themselves, the FDA 24 data itself indicates -- you know how many reports the FDA 25 actually gets of adverse events in connection with a drug? 61 1 Only 10 percent. This is the tip of the iceberg, apparently, 2 according to FDA data. So you can multiply this number times 3 10. Lilly says there is no causal connection. The adverse 4 event form itself says there's no causal connection here 5 presumed. Somebody -- the doctors on the line, the doctors 6 actually giving this medication thought there must be such a 7 causal relation that they reported it to the FDA. 8 Here's some more data on the postmarketing 9 experience for this drug. When you start looking at the 10 adverse event profiles, postmarketing and premarketing, this 11 compares fluoxetine, which is Prozac, with three other -- four 12 other commonly known, commonly prescribed antidepressants, and 13 the reason these numbers are 1982 to 1991, is that Prozac was 14 being manufactured -- being tested in 1982, so they put in all 15 the data. So these other antidepressants which were already 16 on the market had actually a seven-year head start on Prozac 17 in collecting adverse events. Look what happened. Suicide 18 attempt -- this is only through '91; that's data through '93. 19 Through '91. This is an FDA document, by the way. Through 20 '91, 519 suicide attempts and 468 overdoses and 321 instances 21 of psychotic depression. Compare those numbers. You know, if 22 you say, well, these numbers in a vacuum are worthless. Okay. 23 Maybe so. Here's a comparison. Look at them. Is the glare 24 too much for you? Look at the differences in the numbers. 25 There were 519 reports of suicide on Prozac; there was 4 on 62 1 Trazodone; 9 on Amitriptyline; 4 on Desipramine; and 0 on 2 Imipramine. We'll give these documents to you later. This is 3 a preview of the dangerous nature of this drug. 4 Inward directed violence, suicide, suicide 5 attempts, overdose, psychotic depression. Here's some other 6 statistics. Same period of time. Look at the difference in 7 numbers. But this gives you a percentage because it takes 8 into account the variety of the numbers of prescriptions and 9 people taking it. Look at the differences in percentages 10 here. This is over 9 percent. This doesn't equal 4 percent. 11 This doesn't equal 8 percent. Why is the experience with 12 Prozac so much greater than with other antidepressants? And 13 these other antidepressants in these years had a 7-year head 14 start. 15 Here's a head-to-head comparison over the same 16 years of Prozac with Trazodone, another well-known 17 antidepressant. And this head-to-head comparison compares it 18 on reports per minimum prescriptions, so this is head-to-head 19 equalized data. Well, in 1982 through 1987, Prozac wasn't on 20 the market so there wasn't any reports of Prozac psychotic 21 depression and suicide attempt. But look what happened in 22 1988, 1989, 1990 and 1991. The black numbers are Prozac. The 23 white numbers down here are Trazodone. Graphically look at 24 the difference in this particular side-effect syndrome. Well, 25 it's 15, 20 to 1. 63 1 Closer to home, closer to Louisville, closer to 2 these people, in my judgment, same years comparison of the 3 data of hostility and intentional injury between Prozac and 4 other antidepressants. Look at the difference. Look at the 5 difference. I mean, it's not -- almost not on the scale. How 6 could this be happening? 7 By the way, do you think Lilly's seeing this for 8 the first time? Do you see this number on the corner here? 9 That means they produced it in response to a request for 10 production. They've had it since it was created. 11 Here's a percentage of the totals. Look at the 12 difference in percentage of hostility and intentional injury 13 versus the other antidepressants. The comparisons are 14 startling. Here's maybe the most startling of the 15 comparisons. This is comparing hostility and intentional 16 injury with Prozac and Trazodone. It's equalized on a report 17 per million. Again, there's no Prozac before 1987, but look 18 what happens in 1988. Look what happens in 1989. This is 19 Trazodone and this is Prozac. Look what happens in 1990. 20 Look what happens in 1991. You know, is this drug capable of 21 producing hostility and intentional injury in people? Look at 22 the numbers and look at the comparisons. Again, Lilly is 23 going to say that this is postmarketing data and nobody has 24 investigated this to see if there's a real scientific 25 connection of these numbers. They're going to say there's a 64 1 lot of things that could have caused this. One of the things 2 that could have caused this is the fact that these people are 3 prone to do this. 4 Well, again, when Doctor Thompson here was 5 fixing to be making a presentation to the entire board of 6 directors at Eli Lilly and Company, he asked some of his 7 psychiatrist research associates to review a material in 1990 8 that he was going to produce to the board on this subject 9 because at that time it had come to light that this drug had 10 this problem. And he said in his -- well, I'll just quote it 11 to you. The document speaks for itself. What Doctor Thompson 12 had said on Verbatim 4 was -- here's how it reads. It says 13 -- the psychiatrists at Lilly themselves are saying -- "We 14 feel that caution should be exercised in a statement that 15 suicidality and hostile acts in patients taking Prozac reflect 16 the patients' disorders and not a causal relationship to 17 Prozac." Listen to this. This is their own psychiatrists 18 that are reviewing these marketing reports. 19 "Postmarketing reports are increasingly fuzzy 20 and we have assigned, 'yes, reasonable related', on several 21 reports." Lilly themselves, Lilly's psychiatrists themselves 22 have found on a number -- number of instances that the reports 23 of suicidality, hostility in connection with this drug were 24 indeed related to the drug. 25 We think that the evidence is clear, ladies and 65 1 gentlemen, this drug presents a real potential for a group of 2 people for serious, serious problems. We think that Lilly has 3 hidden that risk, Lilly has gone at length to prevent you 4 people from knowing about these risks, and they freely admit 5 in Germany that the product should be used in connection with 6 sedatives. 7 The next issue you've got to face, of course, is 8 this: Did this drug -- did these problems that we've been 9 talking about here, did this cause Joseph Wesbecker to do what 10 he did on September 14th, 1989. You know, I thought it was 11 curious that counsel for Lilly yesterday in talking about this 12 case in his voir dire, that he turned into an argument, 13 mentioned the word Prozac on only two occasions. What we 14 expect Lilly to do in this case is not defend their drug, 15 because we frankly think the evidence will show that this 16 problem with this drug is indefensible. What they're going to 17 try to do is attack. 18 MR. STOPHER: Objection, Your Honor, to 19 statements about what the other side is going to do. 20 JUDGE POTTER: He's just setting the stage for 21 his next statements about what he thinks the evidence is going 22 to be. Go ahead, Mr. Smith. 23 MR. SMITH: We think they are going to try to 24 introduce evidence that Joseph Wesbecker was so mentally ill 25 and was so sick that Prozac had no effect on him. Don't ever 66 1 lose sight of the fact that Lilly invented, tested, designed, 2 and marketed this drug for people like Joseph Wesbecker. 3 Joseph Wesbecker's mental illness was major depressive 4 disorder, bipolar disorder, schizo-affective disorder. It's 5 uncontradicted in this case by all parties, Eli Lilly, 6 experts, every one of them admit that Prozac was a drug that 7 was appropriate for Joe Wesbecker. 8 What they're doing here, because they can't 9 defend their drug, is they're attempting to convict the person 10 that their drug was supposed to treat. They would picture 11 Joseph Wesbecker as a Charles Manson or a Jeffrey Dahmer or 12 some sorry sociopath that was destined from the womb to commit 13 this act. We think, and we'll present evidence to present 14 Joseph Wesbecker as being no more or no less prior to August 15 1989, when he got this medication; that he was simply 16 depressed, major depressive disorder, psychotic depression. 17 Let me go over with you quickly some of the core 18 facts in connection with Mr. Wesbecker. He's been married 19 twice and had two children. Let me -- before I start this, 20 let me say I'm not defending the criminal act Joseph Wesbecker 21 committed, in doing what he did. What our case is about is 22 that Prozac caused him to do this. When he did this, he was 23 not under the influence of his mental illness and was not 24 under the influence of his past-life circumstances; what 25 caused him to do this was Prozac. He was married twice and 67 1 had two children. He hit his first wife once. He never hit 2 his second wife. He was in maybe a half dozen fistfights as a 3 teenager, and I'm giving that the best evidence I can. He was 4 in jail once as a juvenile but was never convicted of a crime 5 and never charged with a crime as an adult. Loved his sons 6 even though both of his sons -- both of his sons gave him 7 problems. He really didn't start to have serious psychiatric 8 problems until the mid 1980s. His psychiatric problems were 9 primarily centered around depression, which isn't ordinarily 10 associated with violence, unless you're taking Prozac, as you 11 can see. These problems at work that Mr. Stopher had talked 12 about were not such that would cause an individual to commit 13 this type of act. The fact of the matter is, when Mr. 14 Wesbecker was having these problems at work, he was relieved 15 of, as much as he could have been relieved, of the problem 16 that was causing him the most stress. More importantly, 17 Joseph Wesbecker had been away from Standard Gravure, off work 18 on long-term disability for over a year. That stressor had 19 been primarily taken out of his life. 20 You will see photographs of a large collection 21 of guns. Those guns were collected in 19 -- primarily in 1987 22 and 1988. They were some sports weapons, some assault 23 weapons. The facts are, in May 1989, before he got