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 MONDAY, NOVEMBER 14, 1994 15 VOLUME XXXV 16 17 * * * 18 19 20 21 _____________________________________________________________ REPORTER: JULIA K. McBRIDE 22 Coulter, Shay, McBride & Rice 1221 Starks Building 23 455 South Fourth Avenue Louisville, Kentucky 40202 24 (502) 582-1627 FAX: (502) 587-6299 25 2 1 2 I N D E X 3 WITNESS: JOACHIM WERNICKE, M.D., Ph.D. 4 By Mr. McGoldrick........................................ 5 By Mr. Smith............................................. 39 5 By Mr. McGoldrick........................................160 6 WITNESS: JOHN GREIST, M.D. 7 By Mr. McGoldrick........................................168 8 * * * 9 Hearing in Chambers......................................193 10 Reporter's Certificate...................................225 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 4 FOR THE PLAINTIFFS: 5 PAUL L. SMITH Suite 745 6 Campbell Center II 8150 North Central Expressway 7 Dallas, Texas 75206 8 NANCY ZETTLER 1405 West Norwell Lane 9 Schaumburg, Illinois 60193 10 IRVIN D. FOLEY Rubin, Hays & Foley 11 300 North, First Trust Centre Louisville, Kentucky 40202 12 FOR THE DEFENDANT: 13 EDWARD H. STOPHER 14 Boehl, Stopher & Graves 2300 Providian Center 15 Louisville, Kentucky 40202 16 JOE C. FREEMAN, JR. LAWRENCE J. MYERS 17 Freeman & Hawkins 4000 One Peachtree Center 18 303 Peachtree Street, N.E. Atlanta, Georgia 30308 19 JOHN L. McGOLDRICK 20 JOHN F. BRENNER McCarter & English 21 Four Gateway Center 100 Mulberry Street 22 Newark, New Jersey 07102 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 Monday, November 14, 1994, at approximately 9:08 A.M., said 5 proceedings occurred as follows: 6 7 * * * 8 9 SHERIFF CECIL: All rise. The Honorable Judge 10 John Potter is now presiding. All jurors are present. Court 11 is now in session. 12 JUDGE POTTER: Please be seated. Did any of the 13 jury have any difficulty observing the admonition over the 14 weekend? 15 How about you, Ms. Davis-Spalding, did you have 16 any problems? 17 JUROR DAVIS-SPALDING: No. 18 JUDGE POTTER: Doctor, I'll remind you you're 19 still under oath. 20 Mr. McGoldrick. 21 MR. McGOLDRICK: Thank you, Your Honor. 22 23 24 25 5 1 EXAMINATION 2 3 BY MR. McGOLDRICK: 4 Q. Good morning. Let me begin, if I may, going 5 back to one thing quickly. We had an exhibit last week, 6 Doctor Wernicke, which was this time line. I'm going to bring 7 out part of it and start by asking you this question. In 8 various places on this chart the word PADER appears; it 9 appears in 1988; it appears in 1989 a couple of times; 1990 10 couple, three times, and I guess in '92, '93 and '94. Would 11 you tell the jury what PADER means? 12 A. Yes. That stands for periodic adverse drug 13 experience report. 14 Q. And what is that and with whom does it get 15 filed? 16 A. It's a compilation of all the spontaneous 17 adverse-event reports that are collected by the company and 18 compiled and transmitted to the FDA. 19 Q. Is that routinely done? 20 A. Yes. 21 Q. Thank you. Now, Doctor Wernicke, last week at 22 some length we went through a whole lot of stuff about testing 23 and the documents you go through and the dosage studies and 24 other things. Now, today I'd like to go through a little more 25 quickly some other subjects. First, there's been talk in this 6 1 case about questions raised by the BGA, the German FDA I'll 2 call it, Lilly's answers to those questions and whether Lilly 3 made the FDA aware of all that. You have some knowledge of 4 that subject? 5 A. Yes, I do. 6 Q. First of all, let's just get it straight from 7 the top. Did the BGA ask questions of Lilly? 8 A. Yes. 9 Q. Did Lilly answer all those questions? 10 A. Yes. 11 Q. Was one of those questions about suicidality in 12 the clinical trials? 13 A. Yes. 14 Q. Did Lilly answer that question? 15 A. Yes. 16 Q. Did there come a time when Germany approved 17 Prozac for use in depression? 18 A. Yes. 19 Q. Did the BGA ever require a warning that Prozac 20 can cause or increase the risk of suicide? 21 A. No, they did not. 22 Q. All right. Now, let's turn to the other side. 23 Did Lilly provide the FDA with the BGA's questions to Lilly? 24 A. Yes. 25 Q. Did Lilly provide the FDA with Lilly's answers 7 1 to those questions? 2 A. Yes, we did. 3 Q. Did the FDA thereafter approve the medicine? 4 A. Yes. 5 Q. Did the FDA ever require a warning that Prozac 6 can cause or increase the risk of suicide? 7 A. No, they did not. 8 Q. Was one of your responsibilities, among other 9 people, to respond to inquiries from foreign agencies? 10 A. Yes. 11 Q. Did the BGA at some point raise a number of 12 questions? 13 A. Yes. 14 Q. About how many, if you remember? 15 A. I believe there were 22 questions in the first 16 list that we got in 1984. 17 Q. Is it unusual for a governmental agency in any 18 country to ask questions as a company is trying to present a 19 medicine to them? 20 A. Not at all. It always happens, as far as I've 21 seen. 22 Q. Did other countries approve this medicine for 23 use? 24 A. Yes. 25 Q. Approximately how many? 8 1 A. I believe it's about 75. 2 Q. Now, let's return to the BGA for a minute. Did 3 there come a time when the BGA asked the question about 4 suicidality in the clinical trials? 5 A. Yes. 6 Q. Do you recall that issue? 7 A. Yes. We looked into that. 8 Q. Now, if I could maybe have the easel for a 9 minute. 10 A. While you're doing that, let me clarify. When I 11 say that it's usual for countries to ask questions, those are 12 what we call the major countries. Not every one of the 75 13 countries where it's approved ask their own questions, but the 14 big ones, the first ones always do. 15 Q. Okay. Now, I believe there has been testimony 16 in this trial by the Plaintiffs that there were more suicide 17 attempts in the Prozac group in the clinical trials than with 18 the other medicines or the placebo. Do you recall that? 19 A. Yes. 20 Q. Is that true? 21 A. Yes. 22 Q. And, again, referring to the clinical trials, 23 there were how many suicide attempts and any completions in 24 the Prozac group, do you remember that? 25 A. Thirteen. 9 1 Q. Do you remember how many of those were attempts 2 and how many were suicide? 3 A. There was 1 completed suicide, so 12 attempts. 4 Q. And in the other meds, that is, the comparitor 5 medicines against which Prozac was being compared, about how 6 many or how many? 7 A. There was one that was a completed suicide. 8 Q. And in the placebo, how many? 9 A. None, zero. 10 Q. All right. Now, that looks like a big 11 difference; is that right? 12 A. Well, certainly it would appear that way if you 13 just saw that, yes. 14 Q. And did the BGA ask you about those numbers? 15 A. Yes. 16 Q. And did you respond? 17 A. Yes. 18 Q. All right. Why don't you tell the jury the rest 19 of the story about the 13, the 1 and the 0. 20 A. Well, I have some examples. If I could go up to 21 the easel, I think I could illustrate how one looks at that. 22 Q. All right. 23 A. What I did -- those numbers do look large and if 24 one were to look at nothing else -- 25 MR. SMITH: We're going to object to a narrative 10 1 response to the question, Your Honor. We'd like to have it in 2 question-and-answer form so I might have the opportunity to 3 object to anything that's not permissible under the Rules of 4 Evidence. 5 JUDGE POTTER: I think he's right, Doctor. Why 6 don't you sort of tighten up your answer. 7 A. Yes, sir. 8 Q. First of all, tell the jury again, did you 9 answer the question to the BGA about the 13, 1 and the 0? 10 A. Yes, we did. 11 Q. And in explaining what you did to answer that 12 question, explain to the jury the kind of method you need to 13 do to look at those numbers, and use an example if you need 14 to. 15 A. All right. Allow me to illustrate an example, 16 and I just made up some numbers and I'll have to refer to my 17 notes. Let us just suppose that we had two baseball players. 18 This is a totally hypothetical example. We have two baseball 19 players, we'll call them A and B. And we have these two 20 gentlemen sitting discussing their performance over the last 21 year and they're talking about home runs. They say Baseball 22 Player One had ten home runs during the season and Baseball 23 Player Two had only one. That's a tenfold difference, so 24 these -- it looks like Baseball Player A is a much better 25 player and, in fact, that's what one of the gentleman says. 11 1 "Look, my man is a ten times better player than B." Then his 2 friend says, "Well, how many games did these two players 3 play?" Well, it turns out that Player A played five games and 4 Player B played one game. Now, that then brings you to home 5 runs -- let me abbreviate it home runs per game of two and 6 one, twofold difference. Obviously a much bigger difference 7 than the tenfold difference, but still Player Two looks better 8 than Player One. 9 Q. Excuse me, Doctor. You said it was a much 10 bigger difference than the tenfold difference? 11 A. I'm sorry. Tenfold difference is much bigger 12 than a twofold. Two is bigger than one, but obviously it is 13 now put much more in perspective. Then they say, "Well, how 14 many at-bats did these players have," because they only have 15 an opportunity to hit a home run if they get to go to bat. So 16 let's call them at-bats, and this player had ten chances and 17 this one only got to go once. So now what we're seeing is 18 that we have to look at the raw number, but what also is 19 important is how many games these people played and how many 20 chances they had to be at bat. So what we have to do is 21 divide the number of home runs by the number of games times 22 the number of at-bats. And that number ten divided by ten and 23 one divided by one and that equals one, and this one equals 24 one, and now we see that these are exactly the same. 25 Q. So you have to look at more than just the raw 12 1 numbers you start with, but the other facts? 2 A. Absolutely. 3 Q. All right. Now, let's turn to this issue of 4 adverse events with a medicine and the BGA's question 13 in 5 Prozac, 1 with the comparitors and 0 with the placebo, but 6 let's explain how that works in the medical context and give 7 us an example there. 8 A. All right. Let's use the same kind of a setup. 9 We have two drugs and let's say now we're looking at a rash. 10 Q. Is this a hypothetical example? 11 A. This is a hypothetical example but, again, 12 becoming more real. This is the way it's really done and this 13 is the way it has to be done in order to make any sense out of 14 it. Let's just call them events. 15 Q. That's events of rash? 16 A. Events of rash. Let's say there are 100 with 17 Drug A, 15 with Drug B. That's a 6.7 times greater number in 18 A than in B, which if one just looked at this by itself, it 19 would be disturbing. You would say this drug has a lot more 20 rashes associated with it and these numbers to this level that 21 would be true, but now we find out that the number of patients 22 treated was not the same. There were 200 patients in Group A 23 and only 100 patients in Drug B. This is 3.3 times greater. 24 Again, it's still bigger, but only about half the difference 25 that we saw before. Now, we look into this further and 13 1 discover that how much time these patients had on treatment, 2 so let's say average months on treatment, Drug A was 3, Drug B 3 was 1. Now, the proper way to now get to one number is to 4 talk about events per patient year and you're going to see 5 that all over. What that does is put the number of events 6 into the perspective of the exposure or patients times years. 7 So the proper calculation is events per patient year. I said 8 months up here because it just makes it easier, nice round 9 numbers, but it's the same. So this comes out to 2.0 and 1.1. 10 Now, this difference is a little less. Sorry. Above one. 11 Still a little bit bigger, but now you see that's a lot 12 different than 100 to 15, now it's about 2 to 1. 13 Now, the good question is are these numbers 14 really different. The only way you could say whether these 15 numbers were truly different without doing any more is to look 16 at every patient in the whole world that ever got this drug 17 over all time, both of these groups. Well, clearly that's not 18 possible, so what we do is we estimate whether these two rates 19 are really the same or different, but it's not, well, I think 20 they kind of look different; it's a formal statistical 21 comparison. And let me just illustrate that without going 22 through a whole lot of mathematics. What we say is this: We 23 observe a number of 2. What is that number really. Well, we 24 don't know exactly, but what we do is we talk about what we 25 call confidence intervals. What we can say mathematically, 14 1 and this goes to mathematics and statistics that go back over 2 100 years. They say we can be 95-percent sure that this 3 number of 2.0 -- and this is again just now hypothetical but 4 this has been done with the real numbers -- the 2 number is 5 somewhere between, say, 0.2 and 4. In other words, we can say 6 mathematically we are 95-percent sure if we evaluated every 7 patient in the whole world that ever took this drug over all 8 time that 95-percent sure that the real number would be 9 between 0.2 and 4. So that's with Group A. 10 We do the same thing with Group B. Say Group B 11 the confidence interval falls within 0.1 and 1.8 with the 12 observed number being right in the middle. So we have two 13 confidence intervals. If these overlap, they are not 14 significantly different. The more they do not overlap, the 15 more significantly different they become, and there's a point 16 where statisticians and scientists agree that at that point 17 those numbers are significantly different, and that's how it's 18 done. There's a lot of mathematics that goes behind this, but 19 the principle is that one gets these confidence intervals 20 based on the observations and then decides without any 21 prejudice or thinking what it ought to be, whether these 22 numbers are in fact different or not, and that's what happens 23 when we talk about statistical significant difference. 24 Q. Now, Doctor Wernicke, having given the jury the 25 explanation of -- your examples of how you go about this, when 15 1 the BGA asks the question and when we today look at these 2 numbers, 13, 1 and 0, tell us how that analysis goes. 3 A. Now I'm going to put up real numbers. 4 Q. This is really what happened in the clinical 5 trials? 6 A. Exactly. This is really what happened. And 7 you'll see these numbers again. Now, we're talking about 8 suicide and gestures, we're talking about all of these 9 together, or events -- suicide attempts. 10 Q. Is it gestures or attempts, Doctor? 11 A. Well, it's attempts. 12 Q. Why don't we put attempts. 13 A. Let's call them events. This is just like a 14 rash, and I've got my event numbers. 15 Q. And the event we're talking about is either a 16 suicide attempt or a suicide? 17 A. That's right. Fluoxetine, imipramine, doxepin 18 -- these are now tricyclic drug comparitors in the actual 19 clinical trials -- amitriptyline and placebo. That, of 20 course, is what's referred as a sugar pill. The numbers we 21 observed, 13 on fluoxetine; 0 on imipramine; 0 on doxepin; 1 22 on amitriptyline; 0 on placebo. And those are the numbers we 23 started that people said, "Aren't these much higher." In 24 fact, the BGA had asked about 16, but they misread the table. 25 There was some that weren't even in the trial; there was one a 16 1 year after, one on placebo, so the real number we're talking 2 about is 13. 3 Well, let's just now look at the number of 4 patients: On fluoxetine there were 1,362; imipramine, 394; 5 doxepin, 134; amitriptyline, 71; placebo, 378. So that's one 6 thing we've seen we have to consider. 7 Now, the other piece of information we need is 8 how long are these patients treated. Let's look at average 9 months. Just like in the rash example, 4 on fluoxetine; 3 on 10 imipramine; 3 on doxepin; 1 on amitriptyline; 1 on placebo. 11 This is now the average length of treatment. 12 Now, if we make the appropriate calculation, 13 events per patient month or patient year; that's the way it's 14 usually expressed. Comes out to 0.027 for fluoxetine; of 15 course, 0 for imipramine; no events for doxepin, so that's 0; 16 for amitriptyline, it comes out 0.175; and 0 for placebo. So 17 what we see is that in fact fluoxetine is in the middle, 0 for 18 imipramine, doxepin and placebo, then fluoxtine 0.027, and the 19 highest rate was actually with imipramine. 20 Q. Doctor, before you go forward, let me just say, 21 so that is it true that in the top row you have the 13, 0s and 22 1, and that makes the numbers look like that comparison, but 23 if you take all these proper factors into account you get down 24 to the numbers at the bottom? 25 A. That's correct. 17 1 Q. Now, it looks to me like amitriptyline is a lot 2 higher, maybe -- what's that? 3 A. About five times. 4 Q. Seven or something times higher. Does that mean 5 that amitriptyline in this was a lot worse for suicide? 6 A. No, it doesn't because what I haven't put on 7 yet, and this we would have to do for every one, is calculate 8 this 95-percent confidence level. And when one does that, 9 usually one finds that in fact none of these numbers are 10 different. Statistically, these are all the same, the zeros 11 all the way to the .175, and that is mathematically what there 12 is. 13 Q. Now, when the BGA asked the questions did you -- 14 at some point were all of these numbers provided to the German 15 affiliate? 16 A. Yes. The information was all there. 17 Q. And the ability to calculate statistical 18 significance was all there? 19 A. Yes. 20 Q. And did the German government ultimately approve 21 Prozac? 22 A. Yes, they did. 23 Q. Thank you, Doctor. Now, Doctor, is the issue of 24 suicide important in studying depression or an antidepressant? 25 A. Yes, it is. 18 1 Q. Why is that? 2 A. Well, suicide is a major component of 3 depression. It's a very high risk. 4 Q. You mean the people who have the disease and 5 know medicine? 6 A. Yes. 7 Q. Now, when the BGA asked the questions it asked, 8 did Lilly consult with anybody about the issue of suicidality? 9 A. Yes, we did. 10 Q. And what did you do? 11 A. Well, we talked with Doctor George Winniker, who 12 is one of the leading experts on suicide behavior, and we knew 13 that from the literature, from talking to our investigators. 14 He's at University of Iowa. So we called him and said, "We've 15 been asked these questions and although we've done 16 calculations, it doesn't look like there are any more. Help 17 us evaluate this because we're not experts in this area." 18 Q. And did Doctor Winniker and his colleagues at 19 the University of Iowa look at that question for you? 20 A. Yes. They looked at the data that we had. 21 Q. And what did they conclude about any 22 relationship between Prozac and suicidality? 23 A. There was no relationship between use of Prozac 24 and suicidality. 25 Q. All right. Now, let me ask you another question 19 1 that's been raised and I think maybe the BGA raised, too, at 2 the time, and that is this question about whether Prozac is an 3 activating antidepressant. Do you recall that issue being 4 raised? 5 A. Yes. 6 Q. All right. Now, in that connection looking at 7 the question of activation, did you look at concomitant 8 medicines? 9 A. Yes. 10 Q. And you did that -- strike that. Maybe I'll go 11 up to the board again. 12 Could you tell the jury what you did? And I'll 13 try to write it down the best I can. Sorry. I'd better bring 14 this out again first. 15 Please tell the jury what you did in looking at 16 the concomitant medicines in trying to look at the activation 17 question. First of all, explain what a concomitant medicine 18 is. 19 A. It's a medicine that's taken in addition to the 20 study drug, so in the study we've been talking about, the 21 fluoxetine-imipramine-placebo study that would be something 22 taken in addition to. 23 Q. Okay. Now, what did you do? 24 A. We looked at the frequency of use of those 25 concomitant medications, specifically the ones that were 20 1 anti-anxiety or sleep-inducing. 2 Q. Why did you do that? 3 A. Well, the hypothesis was or the question was 4 since fluoxetine is not sedating, do patients who have sleep 5 disturbance or agitation, anxiety as part of their depression, 6 do they need to take these medications to suppress that. So 7 then the hypothesis would be, well, if that is true then you 8 would expect a much higher use of concomitant medications in 9 the fluoxetine group than in the sedating tricyclic drug or 10 even placebo. 11 Q. So to see if people were being activated, you 12 looked at whether the doctors were prescribing the sedatives 13 or the anti-anxiety medicines? 14 A. Yes. 15 Q. And you looked at it in the controlled study? 16 A. Yes. 17 Q. And what did you find? 18 A. That in fact the rates were almost identical. 19 There was no statistically significant difference. In all of 20 the groups about 20 percent of the patients took these 21 medications. 22 Q. And all of the groups, you mean which of the 23 groups? 24 A. Fluoxetine, imipramine and placebo. 25 Q. All right. Now, have I asked you to get the 21 1 exact numbers so we could give those to the jury? 2 A. Well, I wrote them down because I have to 3 remember them. 4 Q. First of all, what should my chart look like 5 here? I've got Prozac here in one column. Then what are the 6 other columns? 7 A. Imipramine. 8 Q. Imipramine, that's a tricyclic? 9 A. Yes. A generally sedating tricyclic. 10 Q. I'm going to just write "imip." And then what 11 else? 12 A. Placebo. 13 Q. Okay. And you were looking for how much of the 14 sleep medicine or the anti-anxiety medicine? Are those 15 sometimes called benzodiazepines? 16 A. Yes. There are others that are not 17 benzodiazepines, also. 18 Q. Okay. So we look for sleep or anxiety 19 medications; is that right? 20 A. Yes. Percent of patients taking those 21 medications. 22 A. All right. 23 Q. All right. And what did you find? 24 A. In the fluoxetine group that 19 percent of the 25 patients took them; in imipramine, 20 percent; and in placebo, 22 1 17 percent. 2 Q. Is activation of this sort and therefore the use 3 of sleep or anxiety medicines to deal with it, part of the 4 disease depression, even without a medicine? 5 A. Yes. 6 Q. So did it surprise you to find 17 percent in the 7 placebo group? 8 A. Not at all. In fact, in further analyses we 9 looked at the use of these over time and we found that a lot 10 of these patients, about the same percent was taken at the 11 very beginning of the study before they ever even entered the 12 study. 13 Q. All right. Let's just stay with these numbers. 14 These numbers look about the same, but you've just taught us 15 that you have to be careful about looking at things. Are they 16 statistically significantly different or are they in fact 17 about the same? 18 A. They are the same statistically. 19 Q. All right. Now, in this look you looked at all 20 of the persons in this study who had -- in each of the groups 21 who had received these medicines; is that right? 22 A. Yes. 23 Q. Now, did you also look at a subgroup of the 24 people in that study? 25 A. Yes. 23 1 Q. What was the subgroup? 2 A. Well, we looked at the patients that had what we 3 call agitated depression, with the idea being if these people 4 already had a lot of these symptoms of depression; insomnia, 5 anxiety, nervousness, would they need even more of these 6 sedating medications because fluoxetine was not thought to be 7 sedating. 8 Q. So you looked at this subgroup of the agitated 9 depressed people? 10 A. Yes. 11 Q. Now, these were people who were agitated, 12 depressed, just part of the disease? 13 A. Right. They came into the studies with those 14 properties, characteristics. 15 Q. And is agitation a part of depression for some 16 people? 17 A. Yes. 18 Q. All right. Now, so let's look at the chart 19 again. This time we're looking at agitated-depressed patients 20 and we're looking for sleep and the anxiety medicine. Same 21 three groups? 22 A. Yes. 23 Q. One is Prozac, second one is -- 24 A. Imipramine. 25 Q. Third one is placebo? 24 1 A. Yes. 2 Q. Is that writing large enough? Now, what did you 3 find? 4 A. In the fluoxetine group, 28 percent of the 5 patients took concomitant sedative or anxiolytic medication; 6 in the imipramine, it was 27 percent; and placebo was 32. 7 Q. Now, Doctor, those numbers again, to my eye at 8 least, look kind of the same. Are they significantly 9 different? 10 A. No, they're not. 11 Q. Not statistically significantly different? 12 A. That's correct. 13 Q. Doctor, imipramine is sometimes said to be a 14 sedating antidepressant. What does that mean? 15 A. Well, that a lot of patients that take it find 16 that it makes them drowsy, sleepy. 17 Q. But the medicines that were used here were sleep 18 and anxiety medicines in addition to the imipramine? 19 A. Yes. 20 Q. Now, is the -- did it surprise you to find 32 21 percent using these medicines in people who weren't taking any 22 medicine? 23 A. Well, not really because we know that this is a 24 part of depression and that those are bothersome symptoms to 25 patients, and sometimes they need something to help them with 25 1 that. 2 Q. Now, Doctor, did -- was the information which 3 you've just described to us provided to the FDA? 4 A. Yes. 5 Q. Was it provided to the BGA? 6 A. Yes. 7 Q. Did each of those bodies approve the medicine as 8 safe? 9 A. Yes. 10 Q. Now, Doctor, did there come a time when -- 11 strike that. 12 These numbers you've just given us in both the 13 agitated-depressed part and in the total group and your 14 earlier numbers -- well, are they numbers which were published 15 at some point? 16 A. Well, the drug-use numbers were published, 17 certainly not the baseball example, not all that stuff. 18 Q. Oh, no. I'm just talking about the Prozac and 19 the sleep and anxiety, this one that I showed and the others 20 over here, were they published? 21 A. Yes. Yes. They were published. 22 Q. In a peer-reviewed journal? 23 A. Yes. 24 Q. Now, Doctor, did there come a time later when 25 the FDA asked if you would take a look at Prozac in this 26 1 agitated-depressed group to see if it made their conditions 2 better or worse? 3 A. Yes, we were asked that. 4 Q. And approximately when were you asked that? 5 A. That was part of the approval letter. When we 6 got the final approval they asked us to at some time do an 7 analysis to look at that and I believe one other issue. 8 Q. And did you do that? 9 A. Yes, we did. 10 Q. And did you provide the answer to the FDA? 11 A. Yes. 12 Q. And what were the general overall results of 13 that? 14 A. Well, that in fact fluoxetine worked very well 15 for agitated patients, and in the major studies we looked at, 16 in some cases even better than the imipramine. 17 Q. Now, you're comparing it with the sedating -- in 18 the agitated-depressed group, you compared it with the 19 sedating antidepressant and Prozac worked as well or better? 20 A. Yes. 21 Q. Did you report that to the FDA? 22 A. Yes, we did. 23 Q. Did you in short answer their question? 24 A. Yes. 25 Q. And was that data, do you recall whether that 27 1 was published? 2 A. I'm not quite certain right now. I would have 3 to look at the papers. 4 Q. All right. Well, we can find that out. 5 A. I know that concept was dealt with but whether 6 those exact numbers were published, I don't know. 7 Q. Okay. Were the issues that were raised by the 8 BGA that we've been talking about this morning and Lilly's 9 responses to those issues also provided to the FDA? 10 A. Yes. 11 Q. All right. I want to show you a document, if I 12 can, that's been marked Defense Exhibit 177. 13 Your Honor, I believe this is in evidence, so 14 the ladies and gentlemen of the jury should have it. Okay. 15 Now I have it straight. 16 Let me show you 177, Doctor, and let me ask you 17 what that is. 18 A. This is a letter to the FDA dated March 12th, 19 1985. And it's a transmission of -- it's a part of a report 20 called IND Annual Report and it lists what's in this report. 21 Q. Okay. So it's to the FDA from Lilly; is that 22 right? 23 A. Yes. 24 Q. And that's dated February 1985? 25 A. Yes. 28 1 Q. Now, is the whole report that's contained here 2 in that letter, the attachment there? Let me ask the question 3 differently. You've got a cover letter? 4 A. Yes. 5 Q. It says that there is an attachment? 6 A. Yes. There are a number of appendices to this. 7 Q. Are all of the appendices there or just the 8 index? 9 A. What I have here is just one -- a part of one of 10 the appendices. 11 Q. And let me ask you this: Does this appear to be 12 the whole thing? 13 A. (Reviews document) It appears to be. 14 Q. I won't ask you to look through every page. For 15 the record, the jury has the cover but not the whole, big 16 thing at this point. Now, Doctor, were the answers to the 17 BGA's questions in connection with that exhibit? 18 A. Yes. This exhibit contains the questions from 19 the BGA. 20 Q. Okay. Now let me jump ahead a little. Was 21 there some confusion, Doctor, about communication with the FDA 22 about what the BGA meant by the phrase unacceptable damaging 23 effects and severe organ damage? 24 A. Yes, there was. 25 Q. Let's get one thing clear. Whatever else, did 29 1 the company tell the FDA what these terms meant? 2 A. Yes. 3 Q. Now, perhaps I could have Exhibit 67. This is 4 again in evidence; it's Plaintiffs' Exhibit 67. Now, would 5 you tell the jury what that is, sir? 6 A. This is a letter dated October 26, 1987, from 7 Doctor Talbott to the FDA in response to the FDA's wanting to 8 have a discussion of all foreign regulatory activity. 9 MR. McGOLDRICK: With the Court's permission, 10 this is in evidence already. I wonder if I could ask that 11 another copy just be handed out. 12 SHERIFF CECIL: (Hands document to jurors). 13 Q. All right. We'll work off this one, Doctor 14 Wernicke. If I may come up here, Judge. 15 Doctor Wernicke, first, what is the first page 16 of that exhibit? 17 A. It's a transmittal letter. 18 Q. From whom to whom? 19 A. From Doctor Max Talbott to the FDA saying that 20 this is the report that they had asked for. 21 Q. All right. Now, I'm going to call your 22 attention to -- these pages aren't numbered as such except 23 with the PZ number on the side, but I'm going to call your 24 attention to what's the third page, and does that have a title 25 at the top? 30 1 A. Yes. It says, "Actions taken by other national 2 regulatory authorities." 3 Q. And this is your thing you sent to the FDA? 4 A. Yes. 5 Q. All right. Now, I'll call your attention to -- 6 let's see -- the seventh page. I think it's on the side, it 7 says PZ 65 1967. And does this page and the next page 8 contain -- I'm sorry. I think it's PZ 65 1967. 9 JUROR BAILEY: Ours are 164 something. 10 JUDGE POTTER: Madame Sheriff, will you pick up 11 the 67s or one of them so he'll know what we're dealing with. 12 Q. All right. I think we have it clear. The page 13 that has at the top, "Actions taken by other regulatory 14 authorities," that's Page PZ 65 1963 or -4? 15 JUDGE POTTER: It's your problem. Do you want 16 my sheriff to collect them all up? 17 MR. McGOLDRICK: I think if Your Honor could, 18 that would be best. Let me try this, Judge. 19 JUDGE POTTER: Why don't you use the TV thing. 20 MR. McGOLDRICK: Maybe I'll move this out of the 21 way and use the TV, and we'll get these copies out to the 22 jury. All right. Let me see if I can work with this machine 23 here. All right. This is going to be hard to see, but I'll 24 zoom in when it comes time. 25 MR. SMITH: May we approach the bench, Your 31 1 Honor? 2 JUDGE POTTER: Uh-huh. 3 (BENCH DISCUSSION) 4 MR. SMITH: I need to sit over so I can see what 5 he's doing, but I can't sit in Joe's lap. Can Mr. Freeman 6 come over? 7 JUDGE POTTER: We'll break the one-chair rule. 8 I had an extra chair brought in and Mr. Myers took it. 9 They're far enough away from the jury box. 10 (BENCH DISCUSSION CONCLUDED) 11 Q. All right. Now, I'm going to give you another 12 copy of Plaintiffs' Exhibit 67, and I should have one. Let's 13 show they're the same. All right. Now, Doctor, first of all, 14 let's start from the top. This is the cover letter, 15 Plaintiffs' Exhibit 67 and this is -- who is it to? 16 A. It's to the FDA from Doctor Max Talbott. 17 Q. And the date? 18 A. October 26, 1987. 19 Q. There. Okay. Now, let me call your attention 20 to I guess what's the next page on this document, which I'd 21 better zoom down again. At the top what does that say, sir? 22 A. "Actions taken by other national regulatory 23 authorities." 24 Q. All right. And this is the document in which 25 you were reporting to the FDA about other regulatory 32 1 authorities? 2 A. Yes. 3 Q. All right. Now, I ask you to leaf ahead a few 4 pages until we come -- there's England. Let's come to Germany 5 where it says, "German regulatory correspondence." See where 6 it says that at the top? 7 A. Yes. 8 Q. Let me just zoom that page down so the jury can 9 see that. Okay. That's that whole page and at the top, that 10 says, "German regulatory correspondence." Now, on that page 11 and the next page, what are all those things with numbers 12 listed on the side? 13 A. Those are the questions that were asked of us in 14 1984 by the BGA. 15 Q. Okay. And this is your letter sending those 16 questions to the FDA? 17 A. Yes, for the second time, actually. Because we 18 had submitted those questions also in '85. 19 Q. In that big pile that I just handed you? 20 A. Yes. 21 Q. Now, turn to the next page or I guess the second 22 page there and there is a section in there that says 23 "Additional questions." Do you see that, Doctor? 24 A. Yes. 25 Q. All right. Now, under that there are listed 33 1 additional questions; is that right, sir? 2 A. Yes. 3 Q. All right. Now, let's turn over to the next 4 page, the top, the additional questions continue; is that 5 right, sir? 6 A. Yes. 7 Q. All right. Let's look at the first additional 8 question and this is one of the BGA's questions and let's look 9 at the last line of that first carryover item, I guess. You 10 can read the whole thing, if you like. What do those words 11 say at the end? It says Number Two on the left. Do you see 12 it? 13 A. On the top left. 14 Q. Yes. 15 A. Okay. "For the drugs concerned, there is 16 according to their specified profile of adverse effects, the 17 justified suspicion that they have unacceptable damaging 18 effects." 19 Q. All right. And then under that, numbers 2.1, 20 2.2 and 2.3, are explained, various other questions they have 21 may be under that category; is that right, sir? 22 A. Right. It appears now to be an explanation of 23 what they mean by unacceptable damaging effects. 24 Q. All right. And they go on and in the first 2.1, 25 they ask the question whether there is an increased risk of 34 1 suicide; is that right, sir? 2 A. Well, it's written as a statement, not as a 3 question. 4 Q. But these are, in effect, questions that you 5 answered, did you? 6 A. Yes. 7 Q. You sent the answers over to Germany? 8 A. Yes. 9 Q. And after you sent those over to Germany, they 10 approved the medicine? 11 A. Yes. Sometime later. 12 Q. Now, in the next -- next category there's an 13 issue or a question raised about agitating effects; is that 14 right, sir? 15 A. Yes. 16 Q. And then in the next category there's a question 17 about anxiety, insomnia and agitation; is that right, sir? 18 A. Well, that's part of the second question. 19 Q. Right. These are all subheads of that second 20 question? 21 A. Yes. 22 Q. All right. Now, just to go back, the FDA asked 23 these questions -- excuse me. Strike that. 24 The BGA, the German government asked these 25 questions; is that right? 35 1 A. Yes. 2 Q. You provided the answers? 3 MR. SMITH: I'm going to object to the continued 4 leading questions. 5 JUDGE POTTER: Sustained. 6 Q. Withdrawn. Did you provide the answers to the 7 BGA? 8 A. Yes. 9 Q. Is this letter an example of sending the 10 questions to the FDA? 11 MR. SMITH: Same objection, leading, Your Honor. 12 Q. Did you send the questions that the BGA asked to 13 the FDA? 14 A. Yes, we did. 15 Q. And is one of the methods this letter? 16 A. Yes. 17 Q. Thank you. 18 Judge, at an appropriate time when I can get 19 them together, we'll get this document to the jury. 20 JUDGE POTTER: If they already have it, we've 21 kind of developed a policy that you only get to put it in 22 once. 23 MR. McGOLDRICK: All right, sir. It's No. 67. 24 Doctor, did there come a time in 1985 when there 25 was a psychopharmacology advisory committee meeting with 36 1 respect to Prozac? 2 A. Yes. 3 Q. And very briefly -- the jury's already heard 4 this -- what is the committee and what's it composed of? 5 A. They're a group of outside experts that the FDA 6 calls to give them recommendations about the drug. 7 Q. This was in 1985? 8 A. Yes. 9 Q. What was the question which the FDA asked all 10 these experts in 1985? 11 A. There are two questions: Is this drug safe and 12 is it effective. 13 Q. And this was in '85? 14 A. Yes. 15 Q. What did this panel of experts say? 16 A. They unanimously concluded that it was safe and 17 effective. 18 Q. Okay. Do you recall the precise questions that 19 were asked at that time? 20 A. Not the exact words, but that's how it's 21 phrased. The FDA approaches it, they present their analysis, 22 sometimes the sponsor speaks. I believe we give a summary. 23 Then the FDA asks the committee, what is your opinion, is this 24 drug safe, is it effective, should it be approved. Do you 25 recommend approval is the way they often phrase it. 37 1 Q. So whatever the way the question was phrased in 2 1985, this committee was asked to look at this issue and 3 advise the FDA with respect to this medicine and whether it 4 should be approved? 5 A. That's correct. 6 Q. Did they recommend anything with respect to 7 approval? 8 A. They recommended that it be approved. 9 Q. Did you later provide -- later provide the FDA 10 with a further safety update with additional information? 11 A. Yes, we did. 12 Q. And approximately when did you do that? 13 A. I think that was in 1986. 14 Q. And approximately how much more information had 15 been accumulated by then as measured by the books you sent? 16 A. Well, we sent a submission that was actually 17 larger than the original NDA, in about 200 volumes. 18 Q. And thereafter did the FDA have any other 19 questions? 20 A. Yes. There were a few more questions that 21 followed that. 22 Q. Is this is a normal process in an FDA regulatory 23 situation? 24 A. Yes. 25 Q. Did you answer those questions? 38 1 A. Yes, we did. 2 Q. And did the FDA approve the medicine? 3 A. Yes. 4 Q. And approximately when was that, unless you 5 remember exactly? 6 A. December 1987. 7 Q. Okay. Doctor Wernicke, have you ever had an 8 occasion where you personally prescribed Prozac for a patient? 9 A. Yes. Several times. 10 Q. Can you just tell us a couple of those? 11 A. When I was a neurology attending at Indiana 12 University -- 13 MR. SMITH: May we approach, Your Honor? 14 JUDGE POTTER: All right. 15 (BENCH DISCUSSION) 16 JUDGE POTTER: Where are you going with that? 17 MR. McGOLDRICK: I'm just going to ask about a 18 couple of occasions where he prescribed the medication and if 19 he had any problems with it. 20 JUDGE POTTER: Okay. I'm going to sustain the 21 objection. 22 (BENCH DISCUSSION CONCLUDED) 23 Q. Doctor, do you have an opinion as to whether 24 Prozac is safe and effective? 25 A. Yes, I do. 39 1 Q. What is that opinion, sir? 2 A. That it is safe and effective. 3 MR. McGOLDRICK: Cross-examine, Your Honor. 4 JUDGE POTTER: Mr. Smith, do you want to start 5 now or do you want to take a morning recess? 6 MR. SMITH: Why don't we leave it up to the 7 jury. 8 JUDGE POTTER: Let's go ahead and take a morning 9 recess; it's just a good time to break. 10 As I've mentioned to you-all before, do not 11 permit anybody to talk to you about this case; do not discuss 12 it among yourselves, and do not form or express opinions about 13 it. We'll take a 15-minute recess. 14 (RECESS) 15 SHERIFF CECIL: The jury is now entering. All 16 jurors are present. Court is back in session. 17 JUDGE POTTER: Please be seated. Doctor, I'll 18 remind you you're still under oath. 19 Mr. Smith. 20 21 EXAMINATION 22 23 BY MR. SMITH: 24 Q. Doctor Wernicke, is it your position that Eli 25 Lilly and Company fully and completely disclosed to the United 40 1 States Food and Drug Administration what the German government 2 meant by unacceptable damaging effects? 3 A. Yes. 4 Q. Let me show you what's been marked as Exhibit 5 170, Doctor Wernicke, and is already in evidence. Take a 6 minute to look at that. 7 Your Honor, I have some extra copies. 8 JUDGE POTTER: Was that on the list they were 9 going to bring? 10 JUROR BAILEY: Yes. 11 JUDGE POTTER: Okay. They've got it, Mr. Smith. 12 Q. Have you had an opportunity to review Exhibit 13 170, Doctor Wernicke? 14 A. Yes. 15 Q. Now, you and I have talked about this exhibit 16 before, haven't we? 17 A. Yes. 18 Q. And this is a letter to the Food and Drug 19 Administration dated December 4th, 1987, is it not? 20 A. Yes. 21 Q. And it's authored by Doctor Max Talbott, who at 22 the time was the director of medical regulatory affairs, was 23 he not? 24 A. Yes. 25 Q. He was the primary liaison between Eli Lilly and 41 1 Company and the United States Food and Drug Administration, 2 wasn't he? 3 A. Yes. 4 Q. Do you know that he's still employed by Eli 5 Lilly and Company? 6 A. As far as I know. 7 Q. And is still in Indianapolis, Indiana? 8 A. As far as I know. 9 Q. Two hours up Interstate 165 (sic)? 10 A. I haven't driven it, but I've heard that that's 11 about how far it is, yes. 12 Q. Look in the second paragraph in Doctor Talbott's 13 letter to the Food and Drug Administration. The last sentence 14 there says, "In February 1985 in response to this submission, 15 the BGA alluded to unacceptable damaging effects. This phrase 16 was not defined." Correct, sir? 17 A. That's what it says, yes. 18 Q. And there Doctor Talbott is advising the Food 19 and Drug Administration specifically in response to a specific 20 question that the FDA had asked Lilly about this issue raised 21 by the German BGA; correct, sir? 22 A. Yes. 23 Q. And he tells them in this letter of December 24 4th, 1987, that the BGA didn't define it; correct, sir? 25 A. That's what this letter says, yes. 42 1 Q. We have already introduced, Doctor Wernicke, 2 Exhibit 171. Take a look at that, would you please, sir. 3 That's Exhibit 171; correct? 4 A. Yes. 5 Q. And, again, you and I talked about this in your 6 deposition in Houston, Texas, did we not? 7 A. Yes. 8 Q. This is a memoranda, apparently, written in 9 connection with the letter that Doctor Talbott had wrote to 10 the FDA; correct, sir? 11 A. Yes. 12 Q. And this memoranda is talking about that letter 13 and about this issue, isn't it, sir? 14 A. Yes. 15 Q. The second paragraph there says the letter -- 16 that's the letter from Doctor Talbott; correct? 17 A. (Nods head affirmatively). 18 Q. Asserted that the German authorities never 19 defined or documented the phrase severe organ damage or 20 unacceptable damaging effects which were used in their 21 communication to the company. The letter denied that any such 22 organ damage has ever occurred in fluoxetine-treated patients; 23 correct, sir? 24 A. Yes. That's what it says here. 25 Q. Well, that wasn't true, was it, that the letter 43 1 from the BGA never defined unacceptable damaging effects, was 2 it? 3 A. This is a result of a confusion that we talked 4 about earlier, and what's missing here is the word "other." 5 The way that I interpret this, now looking at all the 6 documents, I know exactly how this happened and I'll be more 7 than happy to explain it because I now understand why there 8 was confusion. 9 Q. Well, you know, did you do anything at the time 10 to clear up this confusion? 11 A. Yes. I asked Doctor Weinstein to communicate 12 with the German affiliate to ask if there was anything else 13 that was meant by severe organ damage other than the 14 elevations in laboratory abnormalities and the issues that we 15 had discussed and analyzed with the FDA and the BGA. 16 Q. We're not talking about severe organ damage, are 17 we? We're talking about unacceptable damaging effects, aren't 18 we? 19 A. Well, we are now but in my mind when -- I am 20 responsible for this confusion, and I understand now why I was 21 confused because I never saw those words unacceptable damage 22 in that context, and in my mind that was all the same issue. 23 I thought they were all just talking about organ damage and we 24 had, in fact, submitted all that to the FDA and the BGA. So 25 in my mind there was nothing else beyond that. 44 1 Q. Well, actually, what the letter that -- the 2 definition that the BGA gave you in Plaintiffs' Exhibit 67 has 3 to do with -- on Page PZ 1650 of Plaintiffs' Exhibit 67, do 4 you still have that in front of you, sir? 5 A. No. 6 Q. Can I approach the Witness to show him, Your 7 Honor? 8 JUDGE POTTER: Sure. 9 Q. If we go up there, Item Two doesn't say a thing 10 about organ damage, does it? It talks about they have 11 unacceptable damaging effects, doesn't it? 12 A. In this letter that's what it says, yes. 13 Q. Well, that's the letter we're talking about. 14 That's where the phrase was raised, wasn't it? 15 A. Yes. But I didn't see that letter until all 16 these depositions and all this. When I was asked that 17 question, in my mind that was all the same thing, and I was 18 responding to severe organ damage and unacceptable damaging 19 effects all in the same context because I didn't see that. I 20 never had that. 21 Q. You were the medical monitor in connection with 22 this drug at that time, weren't you, sir? 23 A. Yes. 24 Q. And you were responsible in large part for 25 getting this drug approved, weren't you, sir? 45 1 A. I certainly contributed to that process. 2 Q. And you had been given a great deal of 3 responsibility in this drug, hadn't you? 4 A. I would say so. 5 Q. And Doctor Talbott was looking to you to give 6 him those answers, wasn't he? 7 A. He asked me questions and I provided the answers 8 that I had available to me. 9 Q. And actually it's very important now because the 10 definition that the German government gave was 2.1, "The use 11 of the preparation seems objectionable as the increase in 12 agitating effect occurs earlier than the mood-elevating effect 13 and, therefore, an increased risk of suicide exists." 14 Correct, sir? 15 A. Yes. 16 Q. And that's important, isn't it? 17 A. Yes. The FDA -- 18 Q. That's involved in this -- 19 MR. McGOLDRICK: I wonder if he might finish. 20 JUDGE POTTER: Let him finish his answer. 21 A. The FDA had all of those definitions and that's 22 what I think even now, and that was that -- my own 23 interpretations, what else did they mean, since they had all 24 of those words -- 25 Q. The thing is Doctor Talbott was writing them at 46 1 the time. They had I think Doctor Thompson said 2.5 million 2 pages of documents that this was stuck in, and they were 3 specifically asking about this and Doctor Talbott was 4 specifically responding to them, wasn't he? 5 A. Yes. 6 Q. And he said they didn't define it, didn't he? 7 A. He said that because -- that was my memory -- 8 that there was no further definition of severe organ damage. 9 Remember that I gave Doctor Talbott that information and in my 10 mind, not having seen that 2 and 2.1, .2 and .3, it was all 11 part of the same question. 12 Q. Wait a minute. You hadn't seen this? 13 A. That's what I've said before; that I had at that 14 time had not -- at least I don't remember at the time of the 15 deposition that I had seen that. In thinking back on it 16 further, I still don't remember ever having seen that exact 17 language at the time all of this communication went on with 18 the FDA, and that's why I was confused and concluded that it 19 was all part of this organ damage that we had discussed and 20 analyzed in great detail. 21 Q. You had been the medical monitor for this drug, 22 responsible for this drug since 1984; is that right, sir? 23 A. I was one of the people that was working on it 24 and responsible for it, yes. 25 Q. You were as responsible as anybody was within 47 1 the medical component, weren't you, sir? 2 A. I would say that to a large degree, yes. 3 Q. And you're telling this jury you weren't aware 4 that the German government had raised this issue? You had 5 worked on it and done a response to it, hadn't you, Doctor 6 Wernicke? 7 A. Let me answer the first question. You asked me 8 if I was aware whether they had dealt with that issue and, 9 yes, of course, I was aware of that and we did answer that 10 when we submitted all of that information to the FDA. The 11 question is was I aware of that exact language and the answer 12 to that is no. But, yes, I was aware of that issue. 13 Q. Why didn't you go back to the response that you 14 had filed with the BGA that purportedly you had filed with the 15 FDA and look it up and made yourself completely aware of what 16 you had done to respond to this? 17 A. Because I know that we had submitted all of that 18 information to the FDA and much, much more. 19 Q. But they were asking you for the answer to a 20 question, weren't they, Doctor Wernicke? Doctor Talbott came 21 to you and said, "The FDA wants to know what the BGA means by 22 unacceptable damaging effect," didn't he? 23 A. No. Actually that's not the way it happened. 24 The way it happened was that there was a telephone conference 25 of which I participated. The FDA asked a number of questions 48 1 and one of them was, "By the way, what does the BGA mean by 2 these words?" 3 Q. So the FDA asked you directly? 4 A. There were a number of us involved in that 5 telephone conversation. 6 Q. And it's your testimony that you were confused, 7 you didn't go look it up to give them the proper definition? 8 A. My testimony is that my memory of this back to 9 1984 and '85 was that this had to do with laboratory 10 abnormalities and possible organ damage and that we had 11 answered all of that to the BGA and, furthermore, that we had 12 done a very, very comprehensive analysis with much more data 13 and had submitted all of that to the FDA. 14 Q. When they talked to you did you tell them go 15 back and look at this submission that we made back in 1985 and 16 you'll get the answer; we set it out in toto? 17 A. I don't usually tell the FDA to go and do 18 something. 19 Q. They asked you to give them the answer, didn't 20 they? 21 A. They asked if we had any information about what 22 that could mean. 23 Q. And you did? 24 A. I gave them the answer that I knew at that time 25 and that we had discussed all of that and that was answered to 49 1 the BGA and I knew that they had been given that information 2 and that we had dealt with all of those issues again in a much 3 more comprehensive analysis. 4 Q. But you didn't point them to it. You told 5 Doctor Talbott to tell them they didn't define it, didn't you? 6 A. As I remember, there was no further definition, 7 but all of those words, all of those definitions were in 8 material we submitted to the FDA, at least once. 9 Q. I know that, Doctor Wernicke. I know that it's 10 there, in here, which was part of 2.5 million pages of 11 documents. And your United States Food and Drug 12 Administration was asking you as the proponent, sponsor of 13 this drug 3 days before it -- or 13 days before it was finally 14 approved by the Food and Drug Administration, they were asking 15 you these questions? 16 A. Yes. 17 Q. And I mean, this was something that was a final 18 question they wanted to know, wasn't it? 19 A. Yes. 20 Q. And this was something that stood between this 21 drug being approved by the FDA, this issue, they called you 22 and you were on a conference call with them, weren't you? 23 A. No. I would not agree with that, that that was 24 the issue that stood between the drug and approval; this was 25 just one of the loose ends that they wanted to tie up. 50 1 Q. It was certainly one of the last questions they 2 asked before you got word that they had approved the drug, 3 wasn't it, Doctor Wernicke? 4 A. I would have to look at the documents. I 5 remember that we -- 6 Q. You have it in front of you. 7 A. But I don't have all of the other documents that 8 go between that date and the approval, including any safety 9 updates that we may have sent in the last few weeks. I know 10 that there was a lot of activity at that time and I can't 11 testify that this was the last communication. And it may be, 12 I just don't know. 13 Q. Will you agree with me, this was one of the last 14 communications? 15 A. Yes. 16 Q. This was one of the last telephone conversations 17 you had with them there in December 1987 before it was 18 approved in December 1987, wasn't it? 19 A. As I remember, that it was one of the last ones. 20 Q. And the United States Food and Drug 21 Administration specifically wanted to know what the Germans 22 meant by unacceptable damaging effects and you told them that 23 they hadn't defined it, didn't you? 24 A. To the best of my knowledge there was no 25 definition beyond what we had submitted, and that is the 51 1 context in which I answered that question. 2 Q. But you didn't tell them to look at what you had 3 submitted; you said it wasn't defined, didn't you? 4 A. Defined any further. The reason I don't feel 5 that that's even relevant is because those questions in 1984 6 were based on what was in the original NDA and, remember, we 7 had done that very comprehensive safety review. 8 Q. But, see, you didn't tell the FDA -- you didn't 9 point them back to that, did you? 10 A. I don't believe I need -- 11 Q. You said the Germans didn't define it. 12 A. I don't believe that I needed to point the FDA 13 to that. 14 Q. You don't think so when they were calling you 15 and asking you a specific question about a specific item? 16 A. No. I don't feel that I need to point to that. 17 What I felt and still do need to do is to tell them what my 18 opinion and information was on that issue at the time. 19 Q. That was wrong, wasn't it, at best? 20 A. I don't think it was wrong. 21 Q. It was either a mistake on your part or it was a 22 misrepresentation on your part, wasn't it? 23 A. The most it was was that I had not seen those 24 words "severe damaging effects" and thought that this was all 25 the same, but I would remind you that all of the documents and 52 1 all of the words had been submitted to the FDA so -- 2 Q. I know that. I know that. They knew that. 3 They knew they had something, but the Food and Drug 4 Administration was calling and asking about this particular 5 phrase, "unacceptable damaging effects," weren't they? 6 A. Yes. 7 Q. And Doctor Talbott, based on your information, 8 said this phrase was not defined, didn't he? 9 A. That's what he said, yes. 10 Q. And then in the -- you know it was relied on by 11 the FDA because they referred to in Exhibit 171, "Your letter 12 says unacceptable damaging effects was not defined," don't 13 they? 14 A. Yes. 15 Q. And then approval was granted a few days later; 16 correct, sir? 17 A. A few weeks later. 18 Q. Well, that may have been in some of this two and 19 a half million pages of documents that was submitted to the 20 FDA, and maybe with a real diligent search on the part of the 21 FDA they might have been able to find it, but do you have 22 exhibit -- Plaintiffs' Exhibit 64 in front of you, Doctor 23 Wernicke? 24 A. No, I do not. 25 Q. This goes back in time to September 11th, 1984, 53 1 doesn't it? 2 A. I would have to look at this, if I may. You are 3 showing me a large part. 4 Q. Yeah. But I've shown it to you before, haven't 5 I, Doctor Wernicke? 6 A. Well, let me quickly look over it. Actually, I 7 don't remember seeing this. You may have shown me this, but 8 I've seen a lot of documents and I would have to look at this 9 in some detail to put this into context. 10 Q. Okay. Well, why don't you -- of course it's got 11 Weber Exhibit 4 there, who was the director of the German 12 medical component, wasn't he not? 13 A. Yes. 14 Q. And you are copied on this document, aren't you? 15 A. Yes. 16 Q. You're the last name there, aren't you? 17 A. Yes. 18 Q. In September of '84, you had been with Eli Lilly 19 and Company six months? 20 A. I joined in June so... 21 Q. Four months? 22 A. Four months. 23 Q. All right. Turn with me -- this is the -- it 24 says, "Attached please find the draft of the enclosures which 25 have been made, prepared in Bad Homburg." Correct, sir? 54 1 A. Yes. 2 Q. And the subject of this is draft of the reply to 3 the list of concerns; correct, sir? 4 A. Yes. 5 Q. And you knew about this list of concerns raised 6 by the BGA, didn't you? 7 A. Yes. I helped draft a response to those. 8 Q. You helped draft a response to the BGA; correct? 9 A. Yes. 10 Q. And you say you filed that with the FDA; 11 correct? 12 A. Yes. 13 Q. And that's that two-volume submission there? 14 A. I believe that is correct. 15 MR. McGOLDRICK: Your Honor, may I approach the 16 bench for just a minute? 17 (BENCH DISCUSSION) 18 MR. McGOLDRICK: Judge, I want to object only to 19 this extent. Of course, Mr. Smith should be allowed to 20 approach the Witness with a document that the Witness doesn't 21 have and show it to him, but I'm not sure that he should stand 22 in the witness box and hover over him and question him. 23 JUDGE POTTER: Do you have an extra copy of 24 that? 25 MR. SMITH: I'll see. 55 1 (BENCH DISCUSSION CONCLUDED) 2 Q. So I can get out of your face -- that's a Texas 3 phrase, isn't it, get out of your face, get out of my face? 4 A. I think so. 5 Q. Turn with me, Doctor Wernicke, to the last page 6 of Exhibit 64, and if we took a look at the next-to-the-last 7 page, we see that this is part of summarizing an opinion, 8 doesn't it? 9 A. Yes, it says that. 10 Q. The last paragraph of the last page of this 11 response to the list of concerns of the BGA says, quote, and 12 this is Doctor Schenk speaking, is it not? 13 A. Well, it appears to be, but remember I haven't 14 looked at this all recently. It looks like it is. 15 Q. Take my word for it. We've talked to Doctor 16 Weber. "If the drug is used according to the revised package 17 literature, that is, in agitated and suicidal patients only 18 together with concomitant sedative drugs, there should be no 19 doubt on fluoxetine's positive benefit/risk ratio in the 20 treatment of depression." Right, sir? 21 A. That's what this says, yes. 22 Q. Did you tell the FDA that Doctor Schenk had 23 concluded actually five years to the day before Joe Wesbecker 24 went to see Doctor Coleman and Doctor Coleman discontinued 25 Prozac because of his deterioration, did you tell the FDA that 56 1 it was Doctor Schenk's opinion and Lilly in Germany's opinion 2 that this drug would be beneficial and have a positive 3 benefit/risk ratio only if in agitated and suicidal patients 4 it was used together with concomitant medications? 5 A. I'd like to point out that this memo -- 6 Q. I think I can ask you to answer with yes or no 7 to the question, Doctor Wernicke. 8 A. I did not personally tell that to the FDA. 9 Q. Did you ever send this document to the FDA? 10 A. I did not have this document because I am only 11 one of the ccs on the cover memo. It clearly indicates that 12 the attachments were only sent to Doctor Zerbe. I don't 13 remember seeing this entire document except perhaps during the 14 depositions, so I cannot speak to whether and why and how this 15 was sent to the FDA. 16 Q. Okay. Is it your position here that this was 17 submitted to the Food and Drug Administration? 18 A. I don't have a position on that because I just 19 don't know. 20 Q. You are copied with this, aren't you? 21 A. On the cover memo, yes. 22 Q. And you were the one that was primarily 23 responsible for drafting this submission to the BGA? 24 A. The questions to the answers I was largely 25 involved in drafting. 57 1 Q. Did you -- and you're telling this jury you 2 never saw this? 3 A. I am telling you that I don't remember seeing 4 this whole document the way -- certainly not at the time that 5 I was working there. 6 Q. Do you remember seeing the summary of the 7 document? 8 A. No, I don't. 9 Q. Have you looked in here to confirm that in the 10 response -- this response that you sent to the BGA that was 11 two years later sent to the FDA, did you ever look in here to 12 see if that language is contained in here? 13 A. Well, no, because I didn't have this language. 14 Q. Nobody ever told you that it was Germany's 15 conclusion -- Lilly-Germany's conclusion -- not the BGA's 16 conclusion but Doctor Schenk with Lilly in Germany's 17 conclusion that this drug would be safe only if used with 18 concomitant sedatives in patients who were agitated and 19 present a risk of suicide? 20 A. You used both of those together, Doctor Schenk's 21 conclusion and Lilly-Germany. Now, it is true that Doctor 22 Schenk worked at the German affiliate and those may have been 23 at the time at one point their conclusion. I do know that the 24 BGA approved the drug and this is not the way it is in their 25 approval. 58 1 Q. It is, too. 2 A. I beg to differ, because what they say, as far 3 as I know -- I may have to look at the language -- but 4 concomitant medications may be necessary; that does not mean 5 that you need to or should or have to use those together. 6 Q. You're saying the difference is "should" versus 7 "may" -- Doctor Schenk says should and the German package 8 insert says may, and you think that's a distinction here, 9 Doctor Wernicke? 10 A. I think that is a fairly big distinction, yes, 11 from a clinical standpoint, certainly another factor. 12 Q. We people here in the United States don't get 13 the benefit of either one of those recommendations, either 14 "should" or "may." It doesn't say anything in the U. S. 15 package insert, does it, sir, about the use of concomitant 16 medication in agitated patients or suicidal patients, does it? 17 A. That's correct. 18 Q. Did you ever discuss this question with Doctor 19 Zerbe of whether or not the benefit/risk ratio, which I 20 believe you said Friday was the ultimate issue in safety, 21 isn't it? 22 A. Yes, I would agree. 23 Q. Whether there's a positive benefit/risk ratio? 24 Didn't you say Friday that's the real issue; that's what we 25 want to know? I believe your term was, at the end of the day 59 1 we want to know whether or not this drug was safe and the way 2 we define it is whether or not it has a positive benefit/risk 3 ratio; right? 4 A. Yes. That's correct. 5 Q. And here Doctor Schenk, the person that was 6 responsible for Prozac in Germany with Lilly, says it's going 7 to have a positive benefit/risk ratio only if used together 8 with concomitant medications in patients who are agitated and 9 suicidal; right, sir? 10 A. I'm not sure that that's exactly what she says. 11 I don't read this as saying that it has to be used only in 12 conjunction with medication. She said, "If the drug is used 13 according to the revised package literature, i.e., in agitated 14 and suicidal patients only together with concomitant sedative 15 drugs, there should be no doubt on fluoxetine's positive 16 benefit/risk ratio in the treatment of depression." I don't 17 believe that to say that one has to use this drug in 18 conjunction with a sedative medication. 19 Q. Well, if you want to have not any doubt about 20 the positive benefit/risk ratio, that's what she's saying is 21 the way to assure that, isn't it? 22 A. In agitated and suicidal patients she feels, 23 apparently, and I would have to talk to her, that that is 24 something that one can consider, which I believe is expressed 25 in the German package insert. 60 1 Q. When you say that the Prozac was approved in 2 Germany, when Lilly's lawyer was questioning you, you didn't 3 point out that when it was approved in Germany the only way it 4 could be approved was with the language that concomitant 5 sedative medications should be used in cases of suicidality 6 and excitability; correct, sir? 7 MR. McGOLDRICK: If Your Honor, please, I don't 8 think that's an accurate characterization. 9 JUDGE POTTER: Well, the Doctor is familiar with 10 it; if it's not, he can correct it. 11 Go ahead, Mr. Smith. 12 A. I didn't point that out because that wasn't part 13 of the question. And I would also further not -- 14 Q. It's part of the truth, isn't it? 15 A. It is part of much information, but I would 16 actually want to look at the German package insert because I'm 17 just not sure the way you phrased it that's exactly the way 18 they said it. It may be. 19 MR. SMITH: We may as well introduce it into 20 evidence. Offer Exhibit 103, the German package insert at the 21 time Joseph Wesbecker shot the Plaintiffs in this case. 22 MR. McGOLDRICK: May we approach the bench, Your 23 Honor? 24 (BENCH DISCUSSION) 25 MR. McGOLDRICK: Judge, the date of this 61 1 document is 1992. I don't know that it's the same and I'm not 2 sure what the foundation is for this document. 3 MR. SMITH: He's saying he had to see -- 4 JUDGE POTTER: Let him finish, Mr. Smith. Where 5 do you see 1992? 6 MR. MYERS: Last page, Judge, lower left-hand 7 corner. 8 MR. SMITH: Actually, it was approved in 9 December 1989. 10 MR. McGOLDRICK: And Mr. Smith just got through 11 telling the jury that it was approved on the date Joseph 12 Wesbecker shot the Plaintiffs, and that's just wrong. 13 JUDGE POTTER: Well, we don't know whether it is 14 or not. Mr. Smith, why don't you correct your own exhibit to 15 be 1992. Objection is overruled. 16 MR. McGOLDRICK: May I ask for instruction that 17 Mr. Smith's statement with respect to this being the package 18 insert in effect on the date of Joseph Wesbecker's -- 19 MR. SMITH: I'll correct that. 20 (BENCH DISCUSSION CONCLUDED) 21 Q. Doctor Wernicke, I said this was the package 22 insert that was in effect at the time Mr. Wesbecker committed 23 this act. Actually this is dated March 16th, 1992, which was 24 a translation that we had made after this litigation began, 25 and I am fixing to follow up with you as to the proposed 62 1 package insert for Germany that Lilly was proposing at the 2 time this incident occurred, but as far as currently what the 3 German people have or at least what they had in 1992, does 4 this appear to be a correct copy of that package insert? 5 A. As far as I know. This is the patient insert, 6 by the way. But remember I was not there so I can't testify 7 this is exactly what anybody had in 1992. 8 MR. SMITH: We'd offer 103, Your Honor. 9 JUDGE POTTER: Be admitted. 10 Q. Now, you say this is the patient information? 11 A. Yes. It looks that way to me. 12 Q. We don't get that in the United States, do we? 13 A. No. 14 MR. McGOLDRICK: Judge, may I approach? 15 SHERIFF CECIL: (Hands document to jurors). 16 (BENCH DISCUSSION) 17 MR. McGOLDRICK: Judge, if the Court please, 18 patients don't receive warnings in the United States. The FDA 19 doesn't -- that's not -- just the way the FDA is structured. 20 My understanding from Mr. Myers is that this was not to be 21 mentioned in this trial and here it's mentioned. I object. 22 MR. MYERS: Your Honor, just factually when we 23 went through a number of the depositions of Lilly employees, 24 specifically the German people, I expressed a concern and the 25 Court ruled out some of the testimony about warnings going to 63 1 patients for this very reason, that there's no issue in this 2 case that the patient should have been warned; the question is 3 whether or not the doctor should have been warned. 4 MR. SMITH: I said patients don't get this. 5 MR. McGOLDRICK: It puts that in issue. There's 6 no need to say it. 7 JUDGE POTTER: As I understand, Mr. Smith, the 8 reason you're admitting this is that the German government 9 conclusively came to a different conclusion than the American 10 government? 11 MR. SMITH: Yes. 12 JUDGE POTTER: Okay. I'm going to overrule the 13 objection. 14 (BENCH DISCUSSION CONCLUDED) 15 Q. Doctor Wernicke, turn with me to Page 2 of this 16 exhibit. 17 A. Okay. 18 Q. Under Risk Patients. Do you see it? 19 A. Yes. 20 Q. It says, "Risk of Suicide"? 21 A. Yes. 22 Q. Fluctin, and that's Prozac in Germany, isn't it? 23 A. Yes. 24 Q. It says, "Fluctin does not have a general 25 sedative effect on the central nervous system; therefore, for 64 1 his/her own safety, the patient must be sufficiently observed 2 until the antidepressant effect of Fluctin sets in. Taking an 3 additional sedative may be necessary. This also applies in 4 cases of extreme sleep disturbances or excitability." 5 Correct, sir? 6 A. Yes. 7 Q. That's what the German government approved 8 Prozac on in Germany; right? 9 A. I believe so. 10 Q. With that language? 11 A. I believe so, if this is a true translation, 12 yes. 13 Q. That language is not contained in the United 14 States packaging instruction, is it? 15 A. Not the same words. I know there is a 16 discussion of suicide and that patients have to be monitored 17 very carefully, that suicide is a risk for depression. 18 Q. And it doesn't say, though, that patients taking 19 an additional sedative may be necessary for these types of 20 patients, does it? 21 A. Not to my knowledge, no. 22 Q. And it doesn't say this also applies in cases of 23 extreme sleep disturbances or excitability, does it? 24 A. That's correct. 25 Q. You have relatives in Germany, don't you, still? 65 1 A. Yes, I do. 2 Q. They're getting different information, the 3 doctors there are getting different information about the risk 4 involved in this product than we are here in the United 5 States, aren't they, sir? 6 A. I would not agree with that, because this does 7 not speak to the risk of the product. What this speaks to is 8 how patients, like this, perhaps should be treated. That's 9 far different than the risk of the product. In fact, the 10 German government has exactly the same information as the 11 U. S. government. 12 Q. Isn't it talking about how this product can be 13 used in the safest way, Doctor Wernicke, in patients who were 14 most susceptible to the most horrible types of side effects in 15 connection with this drug? Isn't that what it's talking 16 about? 17 A. I don't think I would be that firm that this is 18 exactly what it's talking about. I think what they're talking 19 about is the disease state, that this drug is not sedating, 20 and as a reflection that medical practice in Germany is a 21 little bit different than in the United States, and the 22 regulatory authorities apparently have a slightly different 23 view of what they should do. This is reflected in the way 24 this is written. 25 Q. Apparently Lilly employees in Germany, as early 66 1 as 1984, had a different view of how this drug should be used, 2 didn't they? 3 A. That seems to be reflected in some of the things 4 that they say. 5 Q. Especially in this response that Doctor Schenk 6 was making to the BGA; correct, sir? 7 A. Yes. I would say that Doctor Schenk considered 8 this as a possible issue, also. Remembering, however, that 9 she is a physician in Germany and she is used to their 10 regulatory background. 11 Q. Well, do you know if Doctor Schenk was doing 12 anything other than trying to give the right information to 13 people of her country in connection with the proper use and 14 the risk that this drug presents, Doctor Wernicke? 15 A. I think that's certainly one of the things that 16 she was doing. I don't see anything that suggests that she 17 herself thought that this was a particular risk. I believe 18 what she was responding to was what the German government 19 would want to see in their labeling, which is entirely 20 consistent with their approach to how labels are written. 21 Q. That's not what she says. She doesn't say, 22 "We'll agree that this is what the German government wants." 23 If you look again -- and I'm not trying to beat this to death, 24 Doctor Wernicke, but I think we had -- you had in 1984 some 25 serious, serious information about this serious side effect 67 1 with this drug and what she's saying here, is it not, if this 2 drug -- if this drug -- she's not talking about treatment, 3 she's talking about this drug, isn't she? 4 A. That's what she says in that paragraph. 5 Q. She says, "If this drug is used according to the 6 revised package literature, that is, in agitated and suicidal 7 patients only together with concomitant sedative drugs, there 8 should be no doubt on fluoxetine's positive benefit/risk ratio 9 in the treatment of depression." Right, sir? 10 A. That is what she says, but the way you started 11 the question I would disagree with that there was a serious 12 side effect. I don't remember your exact words, but you put 13 it in the context suggesting that she thought that there was a 14 serious safety issue with this drug, and that I do not agree 15 with because I've talked with Doctor Schenk many times in the 16 past. 17 Q. Did you ever talk to her about her feelings on 18 this? 19 A. We talked about the use of sedative medication. 20 We talked about the numbers in the analyses. We worked on a 21 lot of issues together. 22 Q. Then maybe you'd better tell this jury what you 23 said to Doctor Schenk about the use of concomitant medications 24 and her recommendation that this was the way to assure a 25 positive risk/benefit ratio in patients who were suicidal and 68 1 agitated. 2 A. I was never asked whether I thought this drug 3 should be used with concomitant medications in any type of 4 patients. Our discussion was what does the data show, what 5 information do we have. 6 Q. Did you ever tell her she's wrong -- 7 A. I don't remember. 8 Q. -- in this recommendation? 9 A. I don't remember that actually being her 10 recommendation. We talked about that concomitant drugs could 11 be given. I explained to her that we had data that showed 12 that it was given in a number of patients, and that was how 13 our discussions were carried out. 14 Q. Did you tell her, "Well, you need to change your 15 opinion here, Doctor Schenk, you're wrong?" 16 A. Remember, as I told you before, I had not seen 17 that entire document. If, in fact, that was her opinion she 18 did not express it in that way to me. 19 Q. She didn't tell you that in these discussions 20 that you had? 21 A. Not in the sense that she thought that we had to 22 give concomitant medications. 23 Q. Could you be mistaken on that like you were 24 mistaken on those unacceptable damaging effects that you were 25 confused about in Doctor Talbott's correspondence with the 69 1 United States Food and Drug Administration? 2 A. All I can remember is the conversations I had 3 with Doctor Schenk. I know we spent a lot of time looking at 4 a lot of the data. In answering the questions, I can't 5 specifically testify to every conversation I had with her, 6 which is now almost ten years ago. 7 Q. I don't know that the jury has in front of them 8 what actually was the recommended package labeling for Prozac 9 in Germany at the time this incident occurred, September 14, 10 1989. It's contained in Exhibit 102, Plaintiffs' Exhibit 102. 11 Let's go over it, and I just have one copy of it. 12 MR. McGOLDRICK: I'm sorry. Mr. Smith, if we 13 could approach the bench. 14 (BENCH DISCUSSION) 15 MR. McGOLDRICK: If Your Honor, please, I object 16 to -- it's the same objection I made before when Mr. Smith 17 talked the first time about how this was the package insert in 18 effect in Germany when Mr. Wesbecker did this incident. This 19 document was dated December 6, 1989. It's after the Wesbecker 20 incident. It's the second time he has said that, and I think 21 it's objectionable and I think the jury ought to be instructed 22 about that by the Court. 23 JUDGE POTTER: Was it within a couple of months 24 of it? 25 MR. McGOLDRICK: That's right. As long as you 70 1 let them know you weren't exact about those dates. 2 JUDGE POTTER: 102 is in. We don't know if that 3 was in effect in September or not, all we know is that was -- 4 MR. McGOLDRICK: The drug wasn't approved, it 5 couldn't have been in effect, we do know that, Your Honor. 6 Mr. Smith is saying it's in effect on the date of -- 7 MR. SMITH: This is what was being recommended 8 as the German package insert. 9 JUDGE POTTER: Okay. 10 (BENCH DISCUSSION CONCLUDED) 11 Q. I'm going to get this right yet, Doctor 12 Wernicke. Actually Fluctin wasn't approved in Germany until 13 December -- late December 1989; isn't that right? 14 A. That's my understanding. 15 Q. Which was after this incident happened in 16 September of 1989; correct, sir? 17 A. Yes. 18 Q. And actually the German government still was not 19 sufficiently satisfied with the safety of this drug to approve 20 this product in Germany at the time that this incident 21 occurred; right, sir? 22 A. I don't know what their concerns were, if any, 23 at that time. I cannot suppose to look into the BGA's mind. 24 Q. In any event, the recommendation from Lilly to 25 the BGA in Germany at the time was contained in Exhibit 102. 71 1 Let me read this with you. It says, "Fluoxetine does not act 2 generally sedating..." Right, sir? 3 A. Yes. 4 Q. "...until the onset of the depressive 5 alleviating effect, the patients have to be observed 6 adequately. In patients with suicidal risk, continuous 7 observation and/or a generally sedating additional therapy can 8 be necessary. In patients suffering from agitation or marked 9 sleep disturbance, Fluctin has to be used with special care." 10 Doesn't it? 11 A. That's what it says. 12 Q. And that was the recommendation for use of 13 Prozac in Germany on September 11th when -- September 14th, 14 when this incident occurred; right, sir? 15 A. I thought you said it was approved after that. 16 I'm not certain of the date. If that's the package insert, 17 that would have come at the time of approval. 18 Q. Well, this is what Doctor Schulze-Solce had 19 presented from Lilly to the BGA to be used as their proposed 20 labeling? 21 A. I would presume that. I'm not quite sure. I 22 have to look at the whole document, but I will take your word 23 for that. 24 Q. All right. Doctor Wernicke, Exhibit 234 is Eli 25 Lilly and Company E-mail dated September 14th, 1989, at 13:56, 72 1 which is about five hours after Joseph Wesbecker committed his 2 act. Can you identify that as Lilly E-mail? 3 A. I don't remember seeing this. I would have to 4 look over it. I know I'm copied on it and apparently I was at 5 the meeting, but I would have to look at it to jog my memory 6 as to this meeting. 7 MR. SMITH: We'd offer 234, Your Honor. 8 JUDGE POTTER: Let him finish looking at it, Mr. 9 Smith, see if he has anything to say. 10 A. (Reviews document). 11 MR. McGOLDRICK: No objection, Your Honor. 12 JUDGE POTTER: Okay. Be admitted. 13 SHERIFF CECIL: (Hands document to jurors). 14 Q. Have you had an opportunity to review the 15 document, Doctor Wernicke? 16 A. Yes. 17 Q. Let me ask you this first: This document is 18 dated September 14th, 1989. That's the day this incident 19 occurred; correct, sir? 20 A. I presume that, as I remember. I don't know the 21 date exactly. 22 Q. The time as noted on Exhibit 234 is 13:56; 23 correct, sir? 24 A. Yes. 25 Q. That would be 1:56 in the afternoon in 73 1 Indianapolis, would it not, sir? 2 A. Yes. 3 Q. This would be then close to 2:00, so we're 4 talking about, about five hours after this incident occurred; 5 correct, sir? 6 A. Yes. 7 Q. Did you know this incident occurred -- had 8 occurred then? 9 A. I don't remember. This is the first time I 10 remember now seeing this memo, and I just can't remember that 11 day in 1989, whether I knew about this incident. 12 Q. We can talk about that. It says that this 13 document is addressed to Doctor Charles M. Beasley; right, 14 sir? 15 A. Yes. 16 Q. He is a psychiatrist at Eli Lilly, is he not? 17 A. Yes. 18 Q. Beverly Fry; correct, sir? 19 A. Yes. 20 Q. She is a systems analyst? 21 A. I believe so. 22 Q. John H. Heiligenstein is a psychiatrist at 23 Lilly? 24 A. Yes. 25 Q. Beth Meloy is who? 74 1 A. She was a group manager of some of the clinical 2 research associates, I believe, I'm not exactly sure what her 3 role was at that time. 4 Q. She's a clinical research associate group 5 manager? 6 A. I believe so. I don't remember exactly what her 7 role was at that time. 8 Q. And clinical research associates are those 9 people at Lilly who help the research physicians in 10 administration of the Lilly clinical trial; correct, sir? 11 A. Yes. 12 Q. And additionally help the research physicians at 13 Lilly in investigating adverse events in connection with the 14 drug; correct, sir? 15 A. That's right. 16 Q. You're listed and then Doctor David Wheadon is 17 listed; correct? 18 A. Yes. 19 Q. And Doctor David Wheadon was at that time a 20 psychiatrist who is a clinical research physician; right? 21 A. Yes. 22 Q. The subject of this meeting five hours after 23 this occurred here in Louisville is mortality in the Prozac 24 depression database; right, sir? 25 A. Yes. 75 1 Q. Now, mortality means death, doesn't it? 2 A. Yes. 3 Q. That could be death by suicide? 4 A. Yes. 5 Q. Homicide? 6 A. Yes. 7 Q. Overdose? 8 A. Yes. 9 Q. Or other causes? 10 A. Yes. 11 Q. It says in attendance Bev Fry -- that's the 12 systems lady; right? 13 A. Yes. 14 Q. Charles Beasley, that's the Lilly psychiatrist; 15 right, sir? 16 A. Yes. 17 Q. Yourself, you are the Lilly Prozac clinical 18 monitor and research physician at the time, are you not? 19 A. I'm not sure whether I was the primary monitor 20 at that time because that role changed over time. 21 Q. You were still intimately involved with Prozac 22 on September 14th, 1989, weren't you, Doctor Wernicke? 23 A. Yes. Somewhat. Less so than before, but I was 24 still involved. 25 Q. And Bruce Dornseif; right? 76 1 A.