CAUSE NO. 67-198478-03 IN THE DISTRICT COURT OF TARRANT COUNTY, TEXAS 67th Judicial District ALCON LABORATORIES, INC. and ) REFRACTIVEHORIZONS, L.P., ) ) Plaintiffs, ) ) vs. ) ) EBW, INC. and EBW LASER, ) INC., ) ) Defendants. ) ______________________________) DEPOSITION OF MORRIS WAXLER, PH.D. Friday, November 19th, 2004 At Charlotte, North Carolina Reporter: Karen K. Kidwell, RMR, CRR . 2 A P P E A R I N G For the Plaintiffs: Troy S. Brown, Esq. MORGAN LEWIS 1701 Market Street Philadelphia, Pennsylvania 19103-2921 215-963-5000 215-963-5001 Fax tsbrown@morganlewis.com For the Defendants: Douglas S. Harris, Esq. LAW OFFICE OF DOUGLAS S. HARRIS 1698 Natchez Trace Greensboro, North Carolina 27455 336-288-0284 dharris12@triad.rr.com Also in attendance: Mark McDaniel * * * * * 3 I N D E X EXAMINATION BY MR. BROWN . . . . . . . . . . . . . . . 4 EXAMINATION BY MR. HARRIS . . . . . . . . . . . . . . 107 FURTHER EXAMINATION BY MR. BROWN . . . . . . . . . . . 178 FURTHER EXAMINATION BY MR. HARRIS . . . . . . . . . . 185 * * * * * E X H I B I T S Plaintiff's Waxler Exhibit Number 1-2 . . . . . . . . 17 Plaintiff's Waxler Exhibit Number 3 . . . . . . . . . 34 Plaintiff's Waxler Exhibit Number 4 . . . . . . . . . 46 Plaintiff's Waxler Exhibit Number 5 . . . . . . . . . 48 Plaintiff's Waxler Exhibit Number 6 . . . . . . . . . 84 Plaintiff's Waxler Exhibit Number 7 . . . . . . . . . 88 Plaintiff's Waxler Exhibit Number 8 . . . . . . . . . 103 Plaintiff's Waxler Exhibit Number 9 . . . . . . . . . 106 * * * * * 4 1 This is the Deposition of MORRIS WAXLER, Ph.D. 2 taken in accordance with the Texas Rules of Civil Procedure 3 in connection with the above case. 4 Pursuant to Notice and/or consent, this Deposition 5 is being taken in the Executive Boardroom at the Marriott, 6 304 E. Greene Street, Greensboro, North Carolina, beginning 7 at 8:56 a.m. on the 19th day of November, 2004, before KAREN 8 K. KIDWELL, RMR, CRR, Registered Professional Reporter and 9 Notary Public. 10 IT IS STIPULATED AND AGREED by and between the 11 parties that review and signing of this transcript by the 12 witness is waived. 13 * * * * * * 14 MORRIS WAXLER, PH.D., upon first being duly sworn, 15 testified as follows: 16 * * * * * * 17 EXAMINATION BY MR. BROWN 18 Q. Good morning, Dr. Waxler. 19 A. Good morning. 20 Q. You and I know each other from chatting at the 21 other depositions. My name is Troy Brown, and I 22 represent the Plaintiffs in this case, Alcon 23 Laboratories and RefractiveHorizons, LLP, in this 24 collection action that they've brought suit 25 seeking nearly two million dollars from EBW for 5 1 procedure fees that haven't been paid for the use 2 of the lasers. 3 Why don't you just state your name and 4 business address for the record before we get 5 started? 6 A. Name and what? 7 Q. Business address. 8 A. Oh, business address. My name is Morris Waxler. 9 Business address is Godfrey and Kahn, 1 East Main, 10 Madison, Wisconsin. 53701 I believe is the zip. 11 Q. And I understand you've been deposed a number of 12 times in the past for other cases? 13 A. No, I have not. 14 Q. You have not? 15 A. No. 16 Q. Is this your first deposition? 17 A. It's my first deposition, however, I will be 18 deposed in another case, totally unrelated to 19 this. Well, they keep delaying it, so God only 20 knows when. Sometime in the next month supposedly 21 now. It was supposed to be in July. 22 Q. Fair enough. I was being presumption based on 23 your CV. 24 A. No, not at all. 25 Q. You were here for yesterday's -- 6 1 A. Correct. 2 Q. So you know the rules. If you don't understand or 3 hear a question of mine, just let me know. 4 A. Right. 5 Q. If you need to take a break, just let me know. 6 Let me finish my question before you give me your 7 answer, and I'll show you the courtesy, and that 8 will be make it easier for the court reporter. 9 A. Great. 10 Q. And Mr. Harris will put objections on the record 11 if he chooses to. That doesn't mean you don't 12 answer a question. You continue to answer 13 questions unless there's an instruction not to 14 answer, which I don't expect we'll hear today. 15 Why don't you tell me who retained you in 16 this case to act as an expert witness? 17 A. I was retained by Mark McDaniels, EBW Lasers. 18 That's basically it. 19 Q. Okay. So you're being paid by EBW Laser, Inc.? 20 A. Correct. 21 Q. Do you have a retention agreement with Mr. Harris 22 or with EBW? 23 A. Yes, with EBW. 24 Q. Okay. And when were you retained? 25 A. Well, must have been -- I can, think to refresh my 7 1 memory about that, but it was six months ago? No, 2 it hasn't been that long. Four months? I'm not 3 actually -- I don't remember the dates, as a 4 matter of fact, to be honest with you. 5 Q. It was, if we put it into context of the 6 depositions that you sat in on in Orlando of the 7 Alcon management, how far prior to those 8 depositions do you believe you had -- 9 A. Couple months maybe. I'm sorry I didn't refresh 10 my memory about that. I don't recall. 11 Q. That's all right. And what compensation are you 12 receiving for your expert -- 13 A. My standard fee is 285 an hour for -- it's what 14 the, Godfrey and Kahn says I'm worth. 15 Q. Up to the point when we're sitting here today, can 16 you approximate for me how much time you spent on 17 this engagement? 18 A. I could tell you more probably in dollar amounts 19 than I can in time. 20 Q. Why don't you tell me in dollar amounts? 21 A. Calculation in my head. Probably roughly 40,000 22 maybe, 35, something like that, 40. 23 Q. Is that approximately EBW has actually paid to you 24 thus far or is that how much you have invoiced? 25 A. He said 40,000. 8 1 Q. Is EBW current on its payments to you? 2 A. Yes. 3 Q. Do you keep a time records billing for -- 4 A. Absolutely. 5 Q. And is that standard Godfrey and Kahn time 6 records? 7 A. Absolutely. 8 Q. It goes into Godfrey's time and billing system? 9 A. I learned that kind of timing as soon as I left 10 the FDA and went to work for Hogan and Hartson. 11 Q. Welcome to my world. 12 A. Exactly. It was interesting. 13 Q. Have you reviewed in full the deposition 14 transcript of Dr. Brian Will? 15 A. No, I have not seen it at all. 16 Q. Have you asked for it from EBW counsel? 17 A. Actually not that particular transcript I haven't 18 asked for. I must say I did see a little snippet 19 of it yesterday that was faxed to Mark because of 20 the issue, the question having to do with the 21 quote that you made. So I did see that little 22 portion. 23 Q. So Mark McDaniels showed you some page or more 24 than one page of Dr -- 25 A. Four or five. 9 1 Q. But you haven't reviewed the transcript -- 2 A. No, not at all. 3 Q. Have you ever met with Dr. Will? 4 A. No, I've talked with him on the phone many times, 5 but I've never met him. 6 Q. And how many times have you spoken with him on the 7 phone? 8 A. Gracious. Six, five or six times. 9 Q. Is that all in connection with your expert 10 testimony in this case? 11 A. Correct. Well, not all. Initially, it had to do 12 with his issues with Alcon Laboratories. I was 13 referred to Dr. Will through a colleague of mine 14 at Bell, Boyd and Lloyd who recommended me to 15 Dr. Will and that's how -- Dr. Will got me in 16 touch with Mark McDaniels so my initial contact 17 was with Dr. Will, a very brief contact. And then 18 EBW retained me. 19 Q. I see. So when was your first contact and 20 referral to Dr. Will? 21 A. Well, it was very close to the time that we 22 computed that I was retained by EBW. It was sort 23 of in that same time frame. When you said -- 24 Q. So sometime in the May, June of this year? 25 A. Yeah, probably would be right. 10 1 Q. Prior to the May-June time period of this year 2 when you first got in contact with Dr. Will, had 3 you ever met or spoken to Dr. Will? 4 A. No, nothing. 5 Q. Had you ever heard of him before? 6 A. Not at all. 7 Q. Had you ever heard of EBW Laser before? 8 A. No. 9 Q. Had you ever heard of Mark McDaniel? 10 A. No. 11 Q. Did you have any prior business relationship with 12 EBW or any of its affiliated entities? 13 A. Not at all. 14 Q. So Dr. Will, you get in touch with him through a 15 referral, and what was the nature of your 16 discussions with Dr. Will initially? 17 A. Initially, he described some problems with 18 outcomes. Partly was retreatment issue and partly 19 other kind of outcome problems with repair, 20 breaks, and things like that. I don't remember 21 the exact discussions. And then quickly, we went 22 to having a telephone conference with Mark. And 23 then it proceeded from there. 24 Q. Did Dr. Will ever retain you for any purposes? 25 A. I -- we are -- he is a client of mine as well, 11 1 although we haven't really -- he hasn't, we 2 haven't pursued anything. 3 Q. Have you been formally retained through a 4 retention agreement? 5 A. I do have one. 6 Q. We're doing the kind of anticipating my question 7 answer -- 8 A. Oh, sorry. 9 Q. Just so that we have a clear record, let me get my 10 total question out. I know you know where I'm 11 going. But we need a clear record. 12 A. Sorry. My wife complains about that a lot. 13 Q. So you do have a formal retention? 14 A. I do. 15 Q. Representation agreement with Dr. Will? 16 A. Correct. That is correct. 17 Q. Okay. Have you billed him for any time or 18 services thus far? 19 A. A few hours, not much because I haven't done much. 20 Q. And then it's Dr. Will who raised the issue of EBW 21 and that you may want to get in touch with EBW? 22 A. Yes, he referred me to EBW. 23 Q. At the time you started talking with Dr. Will, did 24 you know that Dr. Will had a judgment against him 25 by Alcon in the amount of more than $1.6 million 12 1 for procedure fees that he hadn't paid to Alcon? 2 A. No, I didn't know at that time. I learned that 3 subsequently. 4 Q. Did you know when you first started discussing 5 issues with Dr. Will that during the time that he 6 had made allegations of problems with his lasers, 7 he then subsequently performed thousands of 8 procedures on his patients using the same lasers? 9 A. Would you restate that? I'm not -- 10 Q. Sure. Had Dr. Will explained to you that at the 11 same time he was alleging problems with his 12 LadarVision machines in his practice, that he was 13 also performing thousands of additional procedures 14 on patients using those same machines that he 15 alleged to have problems? 16 A. He don't know that that is quite clear to me, that 17 he did. I did eventually learn that he, about the 18 time sequence of when he made the complaints and 19 when he was doing his procedures. But I don't 20 think initially that I really understood those 21 time relationships. 22 Q. And are those time relationships important in any 23 way to the opinions that you're offering in this 24 case with respect to Dr. Will's allegations of 25 problems? 13 1 A. No, not really. 2 Q. And so, is that the reason that you've chosen not 3 to review Dr. Will's extensive transcript in this 4 case where he's serving as a medical expert on 5 EBW's behalf? 6 A. No. I just, it wasn't available, and I didn't see 7 any need to do it. I've read a mountain of 8 material, and, you know, based on what I've 9 reviewed, I just didn't see a need to do that, 10 supplement what I needed for my conclusions. It 11 would be valuable perhaps, but I haven't felt it 12 essential. 13 Q. When you say "it wasn't available," what do you 14 mean by that? 15 A. Well, I, the transcript -- I didn't ask for it, 16 and as far as I know, the transcript is not 17 available to me at least. I haven't seen it. It 18 wasn't offered to me. 19 Q. Okay. 20 A. And so I -- 21 Q. So, just so the record is clear, you know he's 22 been deposed in this case? 23 A. Yes. Oh, yes. 24 Q. There is a transcript? 25 A. Right. 14 1 Q. You haven't asked to see it? 2 A. Right. 3 Q. And either EBW's counsel or Mr. McDaniel hasn't 4 provided it to you? 5 A. Correct. 6 Q. Okay. So you don't know in preparing the report 7 that you've tendered in this case one way or the 8 other what Dr. Will has testified to at deposition 9 under oath about issues that he had with his 10 LadarVision machines? 11 A. Correct. 12 Q. How many conversations approximately have you had 13 with Mr. McDaniel in which you've been provided 14 facts or information that you've used as a premise 15 for your report? 16 A. I've had many conversations -- well, many. Fair 17 number of conversations with Mark McDaniels. Not 18 too many of them actually included discussion of 19 details of my basis for my opinion. There have 20 been a few, but I don't think there have been 21 many. 22 One prior to yesterday, one -- I guess that 23 was Wednesday we had a, sort of discussion, and 24 there was issues there, but mostly it wasn't about 25 the details. It was more general discussion of 15 1 strategy and issues like that, and it was -- there 2 may have been a couple conversations where there 3 was that kind of content discussion. 4 Q. When you say "strategy," what do you mean by that? 5 A. Well, I mean, just sort of what to expect at a 6 deposition and things like that. That's what I 7 mean. 8 Q. Are these meetings that Mr. Harris was involved in 9 or were these one-on-one conversations with 10 Mr. McDaniel? 11 A. Oh, no, these were meetings that usually Doug was 12 involved, Doug Harris was involved. 13 Q. How many conversations have you had with Dr. Sheri 14 Rowen? 15 A. None. I don't know her at all. 16 Q. How many conversations have you had with either 17 Dr. David or Dr. Gay Bernitsky? 18 A. None, don't know them. 19 Q. How many conversations have you had with any of 20 the other eight EBW physicians that used Alcon 21 LadarVisions through EBW? 22 A. I don't even know who they are. 23 Q. Are there documents that you've reviewed as a 24 factual predicate for your report that are not 25 attached in the very extensive appendix that you 16 1 have to your report or are the documents that you 2 used in relying on -- are the documents that you 3 relied on to come up with your report all sited in 4 your monstrous appendix that I have in front of 5 me? 6 A. I would say that I tried to be very thorough and 7 include everything that I reviewed that was 8 pertinent to my decision. There were other 9 documents that I saw as irrelevant things that 10 didn't influence me one way or another that I 11 thought it was a waste of time to list everything 12 I read relating to the people concerned, to spare 13 all of us having to go through all of that. 14 Q. Fair enough. Have you testified in a litigation 15 as an expert in a civil litigation before? 16 A. Not yet. No. 17 Q. So I take it then it's fair to say you've never 18 been qualified or disqualified as an expert in any 19 court? 20 A. That's correct. 21 Q. Have you had an opportunity to review any 22 deposition transcripts in this case? 23 A. No, as a matter of fact, I haven't. 24 Q. Have you reviewed any case summaries prepared by 25 either Mr. McDaniel or Mr. Harris or anyone else? 17 1 A. No. 2 Q. Have you reviewed any pleadings or discovery 3 requests or responses or materials that have been 4 filed with the court? 5 A. I may have seen one early on, but I don't really 6 recall what it was to do with honestly. Seemed to 7 have a lot of legal -- being a nonlawyer, when I 8 see a lot of legal language, I start to glaze 9 over. 10 (Whereupon Plaintiff's Waxler Exhibit 11 Number 1-2, was marked for 12 identification.) 13 Q. (BY MR. BROWN) Fair enough. I'm going to mark as 14 Waxler 1 and 2, 1 being a draft of Dr. Waxler's 15 report dated November 2nd, 2004. And Waxler 2 16 being the final report that we received that was 17 served, that was dated November 3rd, 2004. 18 Dr. Waxler, I've shown you what I've marked 19 as Waxler 1 and 2. As I said, the first one is a 20 draft of your report. Second one is the final. 21 Are those dates accurate that a draft report on 22 the 2nd and then the next day you finalized the 23 report making any corrections? 24 A. Sure. To my best recollection, yeah. 25 Q. Okay. You can put Exhibit 1 aside. I want the 18 1 draft in the record, but when we talk about your 2 report throughout the rest of this deposition, 3 we'll focus on Exhibit 2. Okay? Great. Did 4 anyone other than you perform any of the work that 5 serves as a basis for your report or appears in 6 your report? For example, did you have any 7 associates or colleagues or paralegals or anyone 8 else help you with this? 9 A. No. In fact, we made specific arrangement within 10 the law firm that I do this as myself, that we 11 have a small team, FDA team, and it was felt that 12 they should not review this document. 13 They received a copy of my draft -- actually 14 received a copy of my draft, the first one. But 15 they did not receive a copy of my second one. 16 They reminded me that they didn't want to even see 17 the draft. I've forgotten, not being a lawyer, 18 I'd forgotten what our rules were when we started 19 out. So they quickly told me, "Don't tell us what 20 you're doing." 21 Q. Why is that? 22 A. Well, because they just wanted to not compromise 23 my independence at all with regard to giving my 24 opinion. They didn't want to review my statements 25 with regard to the rules, the FDA issues. One of 19 1 our colleagues is a very, was in the chief 2 counsel's office at FDA. She's really sharp. And 3 I would have loved to have -- you know, I'm the 4 kind of person I like to have other people pick me 5 apart to see whether I made the right sort of 6 conclusions, and I couldn't use her skills which 7 was, would have been nice. 8 But we decided it would be better, if I was 9 the expert, that it would not be a corporate 10 expertise, that it would be my expertise that was 11 purchased in this case, retained, and it would be 12 the basis of my opinion that was at issue. 13 Q. And did you have any discussion with those 14 colleagues in the FDA group at Godfrey with 15 respect to whether, if they reviewed your report, 16 their subjective interpretation of reporting 17 obligations may be different than the opinions 18 you're offering in this case? 19 A. No, no, we didn't discuss it at all. 20 Q. Do you know why then they didn't want to see the 21 opinions and interpretations you were offering in 22 connection with this case? 23 A. No. It was just a way of ensuring that there was, 24 that I was truly independent, that I was offering 25 my opinion and not the, you know, that it was -- 20 1 gee, I'm not a lawyer, so it's hard to know. I 2 think we decided early on that if there were legal 3 opinions, since I'm a consultant hired by, the 4 only one at this law firm as a consultant and a 5 nonlawyer, that I wouldn't be giving legal 6 opinions. And so that my opinion was having to do 7 with the procedures as I understood them and based 8 on my experience and they felt it would be better 9 for, actually better for EBW and better for Alcon 10 that I be, that it be clear that these were my 11 opinions based on my experience and my review of 12 the technical information and my knowledge of the 13 rules. That's all it was. 14 Q. Your retention, though, here is -- strike that. 15 What is your title at Godfrey and Kahn? Are you a 16 partner, of counsel? 17 A. No, I'm a consultant, an FDA regulatory 18 consultant. 19 Q. But you are formally implied by Godfrey and Kahn? 20 A. Absolutely. 21 Q. Now, do you have an understanding that Godfrey and 22 Kahn represents medical device manufacturers? 23 A. Sure. 24 Q. And therefore, Godfrey and Kahn provides advice to 25 those medical device manufacturers in a variety of 21 1 settings with respect to reporting obligations? 2 A. Sure. 3 Q. Just let me finish the question so that we get it 4 on the record. Provides advice to medical device 5 manufacturers with respect to what their reporting 6 obligations are or are not under the FDA's rules. 7 You understand that? 8 A. Correct. 9 Q. And do you have an understanding one way or the 10 other whether any of your colleagues at Godfrey 11 and Kahn in publicly filed cases have taken 12 positions with respect to reportability that are 13 absolutely contrary to your opinions in this case? 14 Do you know one way or the other? 15 A. I don't know one way or the other, but I'm pretty 16 sure they have not. 17 Q. Okay. But to the extent they have, you're not 18 aware of them? 19 A. I'm not aware of them. 20 Q. Who are your colleagues, the lawyers in the FDA 21 practice at Godfrey and Kahn? 22 A. Well the primary lawyers relative recent 23 acquisition by the firm, Patricia Kaeding. She 24 was previously in the chief counsel's office. 25 Q. Could you spell that for the court reporter? 22 1 A. K-E -- I'm sorry. K-A-E-D-I-N-G. And the other 2 is a young lawyer who is a patent attorney who 3 wants to get into the FDA regulatory practice. 4 His name is, easy for me to say, Gabriel Gross. 5 And there are a couple of others that sort of want 6 to get involved, but we have had enough, I haven't 7 brought enough cases in to make it very worthwhile 8 to get involved. 9 Q. Okay. So in your view, the FDA group at Godfrey 10 as presently constituted is you, Ms. Kaeding and 11 Mr. Gross? 12 A. Correct. 13 Q. Other than Waxler 1, your draft report, how many 14 other drafts do you have that you've retained 15 prior to that version? 16 A. I don't honestly know. There probably is an 17 early, you know, my style of working is to develop 18 an outline. And we have a document tracking 19 system that allows me to update the drafts ad 20 infinitum. So probably I have an early outline 21 and then I make a second draft, so there could be 22 two or three. I'm not really sure. It's all 23 retained on our document control system. Some of 24 the early ones may not be very comprehensible. 25 But they, because I start, you know, I shift the 23 1 logic around as I see it. Might work better as I 2 learn more as I read, so sort of a -- but I do 3 keep those if there's any value in them. 4 MR. BROWN: Okay. Well, Mr. Harris, as I did 5 with Dr. Ritchie and Dr. Walther, I'd like copies 6 of those drafts. 7 A. Sure. 8 Q. Thank you. Is it your understanding, Dr. Waxler, 9 that you'll testify at the trial of this matter in 10 January in Texas to the extent that you're 11 accepted by the court? 12 A. Yes, indeed. 13 Q. And do you have a special compensation arrangement 14 for testifying at trial? 15 A. No. 16 Q. It would be the same 285 an hour? 17 A. Yes, same fee. 18 Q. Does the same hourly rate apply for today? 19 A. Correct. 20 Q. Your role in the approval process for LASIK 21 surgery using excimer laser, was that specific to 22 LadarVision or for other manufacturers' PMA 23 approval processes as well? 24 A. Oh, it was for all of them. 25 Q. And that began in around 1994, 1995 when the 24 1 process started for early PRK? 2 A. Well, the process for PRK started unfortunately 3 much earlier than that, but I would say that I was 4 asked by the FDA leadership to take over that 5 group because, frankly, it was in disarray, and it 6 needed some, somebody to get the, get off the 7 dime. 8 Q. So stepping up to the mid-to-late 1990s when PMA 9 approval submissions were being made, say 10 specifically for LadarVision for PRK, what was 11 your role at that time in the process? 12 A. I was the, the chief of the branch that was 13 regulating these products. 14 Q. Okay. And the PMA approval process is a fairly 15 lengthy one? 16 A. Yes. 17 Q. And a fairly detailed process? 18 A. Absolutely. 19 Q. Governed by FDA rules and statutory regulations? 20 A. Correct. 21 Q. Give me a just general sense of the type of FDA 22 scrutiny that is at play for the PMA process that 23 went into the ultimate 1998 PMA approval for 24 LadarVision for PRK? 25 A. Well, you tell me when there's enough detail. 25 1 Q. What I'm trying to get, Dr. Waxler, rather than -- 2 I don't necessarily want a narrative treatise. 3 But I want you to give me a sense for the type of 4 scrutiny that the FDA gives to the PMA approval 5 process before LadarVision for PRK was actually 6 approved with certain conditions in 1998? 7 A. Well, I'll roughly block out what happened and 8 what typically happens, and that is, that the 9 company comes in with a, typically a pre-meeting 10 with the agency to propose a clinical trial. And 11 at that pre-meeting -- it's usually called a 12 pre-investigational device exemption meeting -- 13 they propose, they describe their device 14 technically. 15 In this case, the scanning laser, they would 16 describe all the technical issues, and we have our 17 engineers and our physicists that work for me look 18 at those, ask questions about, you know, how do 19 you actually do this? What's the algorithm? How 20 does it really work? And then the company would 21 propose a particular clinical trial. 22 Now by the time Alcon or wasn't Alcon, it was 23 Autonomous that was there, we had already 24 developed a very specific guidance with regard to 25 what should be contained in those. So we knew, 26 1 you know, what questions to ask. The companies 2 knew what questions it had to answer in order to 3 come in. And we had already developed a sort of 4 Alcon profile we needed to see for the, for the 5 clinical trial in terms of, you know, what were 6 safety issues, what were effectiveness issues. 7 And so we had a good template for the clinical 8 trial because there had been a number of companies 9 that had already preceded them and already 10 preceded them through the ophthalmic devices panel 11 so we had already received input from those 12 experts, ophthalmologists and optometrists and 13 others. 14 Q. Let me stop you there with a few questions. 15 A. Sure. Yeah. 16 Q. From the pre-meeting stage through the ultimate 17 PMA approval letter in November 1998 for 18 LadarVision for PRK, how long of a process was 19 that approximately? 20 A. I don't specifically remember for Autonomous, but 21 they were very, very good. That was an excellent 22 company. They had a tremendous -- Shirley 23 McGarvey was their regulatory affairs person for 24 the company, and she was very, very effective in 25 terms of presenting. She's done -- she's had 27 1 years of, decades of experience in putting 2 together PMAs, so it was very well organized. 3 And so I think it was actually one of the 4 ones that went through quicker than others. She 5 developed a very good rapport with us, and we had 6 a lot of very strong feelings that this was a 7 great product and a great company. So it took 8 make maybe a year and a half, which was quite 9 surprising, from the beginning to the end because 10 some of them took much, much longer and that, 11 because the companies were not, didn't have good 12 internal workings. They didn't present a good 13 package. 14 Q. And is this a process in the PMA approval process 15 in general in which FDA and its reviewers and its 16 supervisors are in a very hands-on review 17 situation with the company that's submitting the 18 approval? 19 A. Absolutely correct. 20 Q. For the clinical trials specific to LadarVision 21 for PRK that was approved in 1998, what is FDA's 22 role in supervising the clinical trials? 23 A. Two roles. One is in making sure the trial is set 24 up with the proper patient protections at the 25 beginning. And then making sure that their 28 1 updates are within those, that we get back the 2 information from the company that they're, in 3 fact, outcomes are not surprising. 4 And basically, the company's responsible for 5 the clinical trial. We review the outcomes of 6 their results and depend on them to actually 7 perform. 8 They do have bioresearch monitoring team that 9 does go out and inspect the research sites. That 10 was not in my group, so I don't know specifically 11 when they did that. But we got no reports of any 12 problems of this, so it ran like clockwork. 13 Q. So ultimately, FDA reviewers and FDA in general 14 before putting through the approval for any 15 device, but particularly here LadarVision for PRK 16 in 1998, reviews the study and results coming out 17 of the clinical trial to determine whether or not 18 the results are acceptable for approval? 19 A. Correct. 20 Q. And whether or not there are any specific 21 conditions for approval to putting the conditions 22 for approval letter that accompanies approval? 23 A. Correct. 24 Q. Okay. When did you leave FDA? 25 A. About four years ago. Whatever date that was, 29 1 just about 2000 -- it was in the fall of 2000, 2 must have been the fall of 2000. 3 Q. So you have an understanding both in connection 4 with this case and probably your experience at FDA 5 that Alcon received PMA approval for LadarVision 6 for LASIK first in the fall of 2000? 7 A. Right. 8 Q. What role did you play in that PMA approval 9 process? 10 A. I had very little, if any, because I was,I had 11 decided to retire about a year earlier, and I 12 asked to be recused from dealing with any issues 13 related to my position. In fact, I took over a 14 different group having to do with hearing aids and 15 other things and also went to a different part of 16 the health and human services to help with the, 17 mediating workplace disputes so I -- I took myself 18 out of that. I think I knew some of the early 19 beginnings of that, of the trial, but then I was, 20 I was out of the loop of the approval for that 21 particular application. 22 Q. Okay. So you have an understanding from your work 23 in this case I take it that Summit Autonomous 24 Corporation filed for approval in or around 25 October 1999 -- 30 1 A. Right. 2 Q. -- for approval of LadarVision for LASIK. 3 A. Right. 4 Q. And then ultimately received approval in September 5 of 2000? 6 A. Right. 7 Q. And you were not involved in any way in that other 8 than happening to know that that approval -- 9 A. Right. 10 Q. -- had been done? 11 A. And I wasn't kept up to date on that. I was -- I 12 specifically asked not to because I didn't know 13 where I was, actually wanted to be a mediator when 14 I left FDA but didn't happen. 15 Q. So did you, was that specific to the Summit 16 Autonomous approval process or you didn't want to 17 be involved in any manufacturers' approval 18 process? 19 A. Any. 20 Q. To the extent that that would then exclude you 21 from serving in a consultant or mediator role down 22 the road -- 23 A. Correct. 24 Q. -- because of conflicts or internal -- 25 A. Exactly. 31 1 Q. I take it because you were retired, you were not 2 involved at all in any of the approvals that led 3 to the October 2002 LadarVision approval for LASIK 4 and custom cornea? 5 A. Correct. 6 Q. Is it fair to say, and I take it you agree with me 7 that in this case, you're not offering an opinion 8 with respect to whether EBW was paid by its 9 various physicians for procedures that were 10 actually performed on the 11 lasers at issue in 11 this case? 12 A. I have no, no knowledge and don't really care. 13 Q. So you don't know and you're not offering opinion 14 and it's not pertinent for purposes of your 15 testimony in this case whether EBW was paid for 16 procedures and whether they then paid Alcon? 17 A. Correct. 18 Q. Okay. And would it be fair to summarize the 19 opinions that you are offering in this report to 20 be a variety of opinions that Alcon violated 21 certain post-approval reporting obligations to the 22 FDA that it had in its conditions for approval and 23 under FDA regs? 24 A. That's part of it, correct. 25 Q. These are all post-approval reporting violations 32 1 or obligations that they failed to follow through 2 with under FDA rules? 3 A. Correct. 4 Q. Okay. Do you have an understanding for purposes 5 of the claims and defenses in this very case, the 6 one that you're serving as an expert, that EBW 7 alleges that only 2 of the 11 lasers at issue had 8 problems? 9 A. I really don't know. I think I may have heard 10 that, but it's sort of not relevant. 11 Q. Okay. So you don't believe it's relevant to what 12 you're doing to determine which, if any, of the 13 specific EBW Lasers at issue in this case did or 14 didn't have problems? 15 A. Correct. 16 Q. Okay. Have you reviewed the complaints and the 17 answers and counterclaims and the pleas and 18 abatement in this case? 19 A. No, I have not. 20 Q. Have you done any inspection of any of the EBW 21 Lasers? 22 A. No, I have not. 23 Q. Would you be qualified in your opinion to do an 24 engineering inspection of a LadarVision machine? 25 A. Definitely not. 33 1 Q. Have you done a specific review and analysis of 2 any of the complaint or service and maintenance 3 records for any of the 11 EBW Lasers at issue in 4 this case? 5 A. Not -- to my knowledge, not EBW Lasers. 6 Q. Okay. So to the extent that -- strike that. The 7 review of documents, are the documents cited in 8 footnotes in your report from Dr. Will and other 9 doctors, not EBW physicians? 10 A. I don't know. There were some other docs there 11 that provided some information. I don't think 12 they were customer service reports to my 13 knowledge. And I don't know which ones were EBW 14 docs, so I don't think so. I think all of the, 15 there are only a few that I reviewed that I saw, 16 and I think they were all provided by Dr. Will, to 17 my recollection. I don't believe I saw any from 18 any other, from any other doc, so I don't -- and 19 as far as I know, Dr. Will is not an EBW -- 20 Q. That is correct. 21 A. I don't really know that, but -- 22 Q. Okay. Dr. Will is not an EBW doc. We'll 23 represent that for you and Mr. Harris will agree. 24 To the extent that you have reviewed any 25 emails or documents purporting to allege 34 1 complaints about laser performance, it is for the 2 doctors referenced in your report and in the 3 records that you received from Dr. Will; correct? 4 A. Correct. That is correct. 5 Q. Again, it's fair to say that you certainly haven't 6 reviewed for any doctor including the EBW doctors 7 any specific patient records? 8 A. Correct. 9 Q. You're not offering an opinion in this case, it's 10 fair to say, that any problems with any of the EBW 11 Lasers specifically caused any economic damage to 12 EBW? 13 A. I wouldn't -- that's not my area of expertise, and 14 I wouldn't have a clue. 15 (Whereupon Plaintiff's Waxler Exhibit 16 Number 3, was marked for identification.) 17 Q. (BY MR. BROWN) I'm handing you what I've marked as 18 Waxler 3, which is the November 2nd, 1998 19 approval letter for LadarVision for PRK, attached 20 to which are conditions of approval. You're 21 familiar with this? 22 A. Yes. 23 Q. With this document? 24 A. Yeah. 25 Q. This is, I take it you agree, the standard type of 35 1 approval letter with conditions of approval 2 attached -- 3 A. Correct. 4 Q. -- for medical device manufacturer? 5 A. Correct. 6 Q. And it is this letter and the conditions of 7 approval attached thereto that form the basis for 8 the company's post-approval obligations to FDA, 9 correct? 10 A. This and subsequent -- 11 Q. Correct. 12 A. -- letters. 13 Q. This and any subsequent conditions attached either 14 independently by FDA or pursuant to PMA 15 supplements? 16 A. Right. And new PMA, there were always some new 17 PMAs. 18 Q. Right. And I think we're talking -- I think we're 19 saying the same thing. 20 A. Right. 21 Q. The letters that come from FDA specifying the 22 conditions for approval as well as any additional 23 guidance from FDA on conditions of approval 24 associated with supplements or new PMAs? 25 A. Correct. 36 1 Q. And we're going to go through the 2000 and 2002 2 letters as well. 3 A. Okay. 4 Q. I just would like to take them serially if that's 5 okay with you. 6 A. Sure, I agree. 7 Q. This was providing notice to Autonomous 8 Technologies Corporation that LadarVision had been 9 approved within certain parameters for PRK, 10 correct? 11 A. Correct. 12 Q. And if you turn to page 2, FDA advises the company 13 at that time that quote, "These restrictions on 14 the device are applicable to Autonomous 15 Technologies Corporation as well as any users or 16 purchasers of this device." Is that correct? 17 A. Correct. 18 Q. And then there's a bunch of, there's numbers 1 19 through 6 which are specifically what Autonomous 20 has to notify users of in their training programs 21 or associated in the labeling or the manual, 22 correct? 23 A. Correct. 24 Q. Nothing in 1 through 6 represent reporting 25 obligations of the company to FDA. They're what 37 1 they have to notify the users of, correct? 2 A. I think that's fair, yes, that's correct. 3 Q. And the sentence before, "FDA advises ATC," which 4 is Autonomous Technologies Corporation, "must 5 notify any purchasers or users of these 6 restrictions and include them in your training 7 programs"? 8 A. Correct. 9 Q. And then it lists serially six things that have to 10 be advised? 11 A. Correct. 12 Q. Then if you turn to page 4, FDA has two specific 13 reporting obligations, in addition to what we'll 14 get to in a moment which are the attached 15 conditions of approval. Do you agree with that? 16 A. Correct. 17 Q. Okay. So for the 1998 PRK approval, FDA required 18 that number 1, in the annual report, for two years 19 following approval, so would you agree that's the 20 1999 and the 2000 reports for LadarVision for PRK? 21 A. Correct. 22 Q. Okay. In those two years, annual reports 23 following approval, the company must report on 24 unscheduled maintenance visits. Correct? 25 A. Correct. 38 1 Q. And then immediately submit reports to FDA of 2 instances of device tampering? 3 A. Correct. 4 Q. Okay. And in the letter itself, those are the FDA 5 reporting obligations of the company before we 6 turn to the attached conditions of approval, 7 correct? 8 A. Correct. 9 Q. Okay. So turn to the conditions of approval with 10 me. 11 (Whereupon Mark McDaniel entered the 12 proceedings.) 13 Q. (BY MR. BROWN) Okay. So the first condition of 14 approval is relating to approved labeling, 15 correct? 16 A. Correct. 17 Q. Company has to submit three copies of an amendment 18 of, to the PMA submission to FDA of the approved 19 labeling in final form, correct? 20 A. Correct. 21 Q. Okay. Then there is some, some conditions with 22 respect to advertising, correct? 23 A. Correct. 24 Q. PMA supplement obligations are next, correct? 25 A. Correct. 39 1 Q. And the obligations in the company are specified 2 in the PMA supplement parts of this conditions of 3 approval as referenced to certain CFR regulations, 4 correct? 5 A. Correct. 6 Q. And then if you turn to page 2 of the conditions 7 of approval, it begins discussing the 8 post-approval reporting obligations of the 9 company, correct? 10 A. Correct. 11 Q. And these are obligations for post-approval 12 reporting in the annual report submitted to FDA, 13 correct? Just this section that's entitled 14 Post-Approval Reports? 15 A. Correct. 16 Q. Okay. And so the two subsets of what needs to be 17 reported in the annual report are, one, changes 18 described in the reference CFR section, correct? 19 A. Correct. 20 Q. And then a bibliography and summary of published 21 and unpublished reports of results from clinical 22 trials with the LadarVision machine for PRK, 23 correct? 24 A. Correct. 25 Q. Okay. Then the next condition of approval is the 40 1 reporting obligations for adverse reactions and/or 2 device defects, correct? 3 A. Correct. 4 Q. And that's governed by this letter and the 5 reference regulations, correct? 6 A. Correct. 7 Q. Okay. And with respect to adverse reaction and 8 device defect reporting, if you look on page 3, 9 we'll skip the first 1, which is mixing of the 10 device with another article. I don't believe that 11 plays any part in any of your reporting, correct? 12 In your report, correct? A mix-up of this device 13 or its labeling with another article? 14 A. No, it's pretty hard to do. 15 Q. Okay. Exactly. Somebody mistakes LadarVision for 16 a chicken hatcher? 17 A. Or a pill. 18 Q. So one we're going to skip? 19 A. Correct. 20 Q. Two makes up the basis for your opinions in your 21 report with respect to failure to report adverse 22 reactions or device defects, correct? 23 A. Correct. 24 Q. Okay. And what the FDA condition of approval says 25 is, the company must report within ten days of 41 1 receiving knowledge concerning, 2, any adverse 2 reaction, side effect, injury, toxicity or 3 sensitivity reaction that is attributable to the 4 device, and A, has not been addressed by the 5 device's labeling, or B, has been addressed by the 6 device's labeling but is occurring with unexpected 7 severity or frequency. Did I read that correctly? 8 A. Correct. 9 Q. And you agree that that is the post-approval 10 obligation for the company for adverse reactions 11 or device defects? 12 A. Correct. 13 Q. And that whatever needs to be reported by the 14 company has to be determined by the company to be 15 attributable to, attributable to the device? 16 A. Correct. With the caveat that, as is often the 17 case with FDA, they reserve the right to question 18 the company's judgment with regard to what they've 19 decided is an adverse reaction. 20 Q. Absolutely. 21 A. After the fact. 22 Q. So let's talk through that process with you. 23 A. Yeah. 24 Q. Under FDA regulations in the interpretive 25 guidelines, the company has to have appropriate 42 1 processes in place to review and evaluate 2 complaints or reports that may or may not fall 3 into adverse reaction or device defect, correct? 4 A. Correct. 5 Q. Okay. And it's the company's subjective 6 obligation at the outset to make that review and 7 determination appropriately, correct? 8 A. Correct. 9 Q. Then FDA always retains the jurisdiction should we 10 say or the right to pose further follow-up 11 inquiries to the company to determine whether or 12 not the processes are adequate or the evaluation 13 was adequate, correct? 14 A. That's correct. 15 Q. So in the initial matter, the company is 16 responsible for having the processes in place to 17 review and make its determination whether or not 18 this needs to be reported? The company ultimately 19 decides whether something is attributable to the 20 device and has to be reported? 21 A. That is a double-edged -- that's what I tried to 22 say before, that there's a double-edged 23 requirement in the sense that if a company -- and 24 I've seen this with other companies 25 unfortunately -- if the company does not, 43 1 unbeknownst to the agency, establishes a set of 2 criteria for adverse events that is not consistent 3 with the criteria for the approval, then while the 4 agency may not know that for a period of time, if 5 the agency becomes aware of that, then the company 6 gets into difficulties. 7 I think that's, that's the part a lot folks 8 don't understand. So that, yes, the company has, 9 sets the, those criteria in its processes, but 10 those must be based upon its approval and all the 11 labeling associated with that approval. 12 Q. I understand. 13 A. I just want to be clear. 14 Q. I'm talking about what the company's letter-based 15 and regulatory obligations are and how they go 16 about that. I think what you were just talking 17 about is a slightly different topic which is 18 potential repercussions to the company if they 19 don't comply with those obligations. Is that fair 20 to say? 21 A. Fair enough. Fair enough. 22 Q. So you're talking about if the company doesn't 23 follow what they're supposed to do and FDA 24 ultimately learns about it through complaints from 25 users or otherwise, FDA may do an investigation, 44 1 and there could be repercussions to the company? 2 A. Correct. That's fair enough. 3 Q. Okay. Good. And we'll talk about some things 4 like that a little later. 5 A. Okay. 6 Q. And then back to adverse reaction and device 7 defect, I don't want to read the entire number 3, 8 but am I correct that the obligations in number 3 9 are not addressed in your report? To be fair, if 10 they are, I haven't seen them, but you tell me if 11 it is. 12 A. Well, I didn't memorize my report, so I can't 13 honestly say. 14 Q. That's fair enough. 15 A. Let me say that I think that some of the apparent 16 corrections that were made after complaints could 17 fall into this category, and I don't remember 18 exactly what I said with regard to that. I didn't 19 highlight it -- 20 Q. Fair enough. 21 A. -- strongly because there's information that I 22 don't have, and I want to be fair to Alcon. I can 23 only make any decisions based on what I know. Not 24 what I don't know. 25 And so I think that there is some, there's 45 1 some issues there, but I don't believe I 2 highlighted them strongly because I, there's some 3 uncertainties there about what was done and what 4 wouldn't done. 5 Q. Fair enough. 6 A. And I couldn't determine what was and -- 7 Q. Just for purposes of what we're talking about, I 8 think we now agree that for the company's 9 post-approval reporting obligations for adverse 10 reaction and device defects, 1, 2, and 3 on this 11 page 3 of Waxler 3 make up the company's 12 obligations? 13 A. Correct. 14 Q. And then we go down to the MDR reporting 15 obligations, correct? 16 A. Correct. 17 Q. And that is that, and again, the same overlay you 18 would agree with me applies in that that company 19 has to have processes in place to do a review and 20 a learned evaluation of complaints to determine 21 whether or not a patient injury falls into MDR 22 reportable category? 23 A. Absolutely. 24 Q. And you agree with me that for MDR reporting, the 25 issue has to be an event that may have caused or 46 1 contributed to a death or serious injury or that 2 the device has malfunctioned, and such device or 3 similar device marketed by the manufacturer or 4 reporter would be likely to cause or contribute to 5 a death or serious injury if the malfunction were 6 to recur, correct? 7 A. Correct. 8 Q. So those are the evaluation categories for the 9 company when determining whether to make an MDR 10 report? 11 A. Correct. 12 Q. And those, you would agree with me that is the 13 landscape in this letter and conditions of 14 approval of the company's reporting obligations to 15 FDA? 16 A. Correct. 17 Q. Okay. 18 MR. BROWN: Mark as Waxler 4. 19 (Whereupon Plaintiff's Waxler Exhibit 20 Number 4, was marked for identification.) 21 Q. (BY MR. BROWN) Dr. Waxler, I'm showing you what 22 I've marked as Waxler 4, another document I think 23 you're familiar with. This is the 24 September 22nd, 2000 PMA approval letters and 25 conditions of approval for LadarVision for LASIK. 47 1 Do you understand that? 2 A. Correct. 3 Q. And this is sent to Christy Stevens at Summit 4 Autonomous Corporation? 5 A. Correct. 6 Q. And this was the approval that you weren't 7 involved in but just happened to know had been 8 submitted prior to your retiring from the agency? 9 A. Correct. 10 Q. And if you go through with me again on the first 11 page of this conditions, of this approval letter, 12 it states initially what the device is indicated 13 for, and those are the parameters within which the 14 device could be used, correct? 15 A. Correct. 16 Q. And if you turn to page 2, similar to what we saw 17 in Waxler 3, there are numbers 1, 2, 3, and 4 with 18 a variety of subsections to number 4 which are not 19 reporting obligations but are obligations of the 20 manufacturer to notify purchasers and users of 21 these various items, correct? 22 A. Correct. 23 Q. And if you turn to the page 4 of the letter, the 24 final page of the actual letter, there are 25 additional specific conditions of approval, 48 1 correct? 2 A. Correct. 3 Q. And there are, there is one additional condition 4 of approval before we go into the actual 5 attachment which is the company has to immediately 6 submit reports to FDA of any instances of device 7 tampering that it learns of, correct? 8 A. Correct. 9 Q. Nothing else in this letter itself that has a 10 reporting obligation until we turn to the next 11 page, the conditions of approval, correct? 12 A. Correct. 13 Q. And then if we go through the conditions of 14 approval, I think you'll find that they are 15 identical to the conditions of approval that we 16 just discussed for the 1998. Would you agree with 17 that? 18 A. Yes, these are boilerplate attached to every PMA. 19 Q. Okay. So we don't need to go through now 20 comprehensively the same thing we just did for the 21 1998 letter because you would agree that 22 everything is the same, and you would have the 23 same answers, correct? 24 A. Correct. 25 (Whereupon Plaintiff's Waxler Exhibit 49 1 Number 5, was marked for identification.) 2 MR. BROWN: Mark this as Waxler 5, please. 3 Q. (BY MR. BROWN) Before we move on, just for a 4 moment, Dr. Waxler, on the September 2000 5 approval, you notice that FDA no longer requires 6 as a condition for approval the report of 7 unscheduled maintenance in annual reports? Did 8 you notice that that was taken out of the 9 September 2000 letter? 10 A. That is correct. However, I should also add that 11 that unscheduled maintenance, although they don't 12 have to be reported, must be retained by the 13 company. 14 Q. Okay. 15 A. It's understood by other reasons. That's why, the 16 agency basically does that in the first approval 17 of a device because there's typically a little 18 more nervousness about the first time the device 19 gets on the market, and they want to keep a little 20 tighter rein, so they want to keep track of those 21 by having those unscheduled maintenance reported 22 in the annual report. But after that, they assume 23 that the company in its own processes will keep 24 track of that but not reported. So you're 25 correct, the reporting requirement is no longer 50 1 necessary. 2 Q. Okay. So that we're clear -- and thank you for 3 that clarification. 4 A. Sure. 5 Q. As of the September 2000 approval of LadarVision 6 for LASIK, the company no longer had an annual 7 reporting obligation for unscheduled maintenance? 8 A. Correct. 9 Q. And the company has to have recordkeeping 10 processes in place whereby they report unscheduled 11 maintenance? 12 A. Correct. 13 Q. And do you have an understanding that Alcon has 14 that in place? 15 A. I have no idea frankly. 16 Q. You don't know one way or the other whether Alcon 17 has recordkeeping that retains information about 18 unscheduled maintenance? 19 A. The only thing I can say is that in an earlier 20 deposition that I assisted in, someone from Alcon 21 said that they didn't understand what unscheduled 22 maintenance was and implied that they didn't know 23 that, that they kept track of it. So I was a 24 little puzzled by that because these were people, 25 managers in the process that seemed like they 51 1 should have known that. So I don't know. I mean, 2 I have no way of knowing. But there seemed to be 3 a little bit of confusion about that. 4 Q. Okay. 5 MR. BROWN: Move to strike the last answer. 6 Q. (BY MR. BROWN) I think maybe we got confused, 7 maybe you got confused about my question. 8 A. Okay. 9 Q. Let's take it this way. I think we established 10 earlier that you haven't reviewed the complaint, 11 service, and maintenance records for the 11 EBW 12 lasers, correct? 13 A. Correct. 14 Q. You have an understanding that those have been 15 produced to the, to EBW? And that they have them 16 in their files? 17 A. I have no idea. 18 Q. So you don't know one way or the other whether 19 they even have them? 20 A. No. 21 Q. Okay. So if there are clear records in the 22 complaint, service, and maintenance records for 23 the 11 EBW lasers that show recordation of 24 unscheduled maintenance for those lasers, you 25 would -- would that, would that be able to inform 52 1 your opinion about whether Alcon has recordkeeping 2 for unscheduled maintenance? 3 A. For that, for those particular ones, that's true. 4 Q. Okay. So if you were to see that, that would, 5 that would be your opinion for that issue, but you 6 haven't seen those records? 7 A. No. And also, I don't know whether, whether and 8 how those records are kept and tabulated within 9 Alcon. Of course, I wouldn't know that. 10 Again, I was surprised to learn that there is 11 some confusion about unscheduled maintenance. But 12 leave that aside, I think that -- I have no way of 13 knowing that. It would be, it would have been 14 helpful to me, in forming my opinion to know, if 15 fact, that there indeed are these unscheduled 16 maintenance records, and they are such-and-such 17 and such, but I didn't have that information. 18 Q. And that may have been -- and in that, if you had 19 that information and had reviewed it you may have 20 been able to offer the opinion that the 21 recordkeeping appears to be in order for 22 unscheduled maintenance? 23 A. I could or I could have said otherwise. 24 Q. Okay. If you look at Waxler 5 which we just 25 marked, this is the October 18th, 2002 PMA 53 1 approval letter for LadarVision for LASIK 2 including custom cornea and an expanded parameters 3 for LadarVision, correct? 4 A. Correct. 5 Q. Okay. And again, this letter sets forth the 6 parameters, and then starting on page 2 has the 7 information that the manufacturer has to notify 8 users of, correct? 9 A. Correct. 10 Q. And that's listed 1, 2, 3, and 4, as well as the 11 subsections, correct? 12 A. Correct. 13 Q. And then there are some specific letter-based 14 conditions which in this 2002 have the 15 manufacturer here, Alcon, having to report 16 instances of device tampering or usage outside of 17 the approved indication, correct? 18 A. Correct. 19 Q. And usage outside of the approved indication, 20 would that be fair in shorthand to call it 21 off-label use? 22 A. Correct. 23 Q. Okay. As well as excimer systems that were 24 exported under 801E and are back in the U.S.? 25 A. Correct. 54 1 Q. And that's perhaps systems that are not approved 2 for use in the United States that were exported to 3 other countries -- 4 A. Correct. 5 Q. -- but because of regulations, that may not make 6 their way back in? 7 A. Correct. 8 Q. Do you understand those to be called "gray market 9 lasers"? 10 A. Oh, yes, I'm quite familiar with them. 11 Q. And that makes up the reporting obligations 12 specifically in this letter before we turn to the 13 conditions of approval, correct? 14 A. Correct. 15 Q. And then we have the conditions of approval which 16 has a modification date different than the 17 conditions of approval for the prior two letters, 18 do you see that? 19 A. Yes, that's correct. 20 Q. Would you agree with me that with respect to 21 post-approval reporting, adverse reaction and 22 device defect reporting and the MDR reporting, all 23 the obligations are the same as what we've talked 24 about for the '98 and 2000 letters? 25 A. Correct, correct. 55 1 Q. So we don't have to go through that again as well? 2 A. No. 3 Q. Wonderful. So just to summarize, we're in 4 agreement that the reporting obligations that we 5 talked about for the '98 letter are the same 6 reporting obligations that the company had under 7 the 2000 letter and the 2002 letter with the 8 exception of the few narrow things we talked about 9 with respect to unscheduled maintenance or 10 off-label use? 11 A. Correct. 12 Q. Okay. See how easy that was to get through? 13 A. Boy, so you're going to make your 1:30 flight. 14 Q. I don't know about that. 15 A. While you're looking for that, could I just for a 16 moment break and call? 17 Q. Sure. 18 A. I have to reschedule my doctor's appointment. I 19 just remembered that. It won't take me but 30 20 seconds. 21 Q. (BY MR. BROWN) Go off the record. 22 (Whereupon an off-the-record conference 23 was held that was not reported.) 24 Q. (BY MR. BROWN) Dr. Waxler, I'd like you to turn 25 back to your report which is Waxler 2? 56 1 A. Okay. Great. 2 Q. I'd like to walk through with you some of the 3 factual assertions throughout and get an 4 understanding of where the factual bases come from 5 and get you to confirm or explain to me some 6 things. Okay? 7 A. Okay. 8 Q. If you turn to page 5 of your report. 9 A. Okay. 10 Q. Or strike that. I'm sorry. Turn back to page 2 11 first because that will put it into context. Your 12 first opinion that you're offering in connection 13 with your report is that Alcon failed to report 14 all adverse events, MDR reportable events, device 15 failures, and unscheduled maintenance to FDA, 16 correct? 17 A. Correct. 18 Q. And then the next three pages of your report are 19 the regulatory background that you're setting out 20 for the company's reporting obligations, correct? 21 A. Well, the first paragraph is the FDA regulations. 22 The second paragraph is -- 23 Q. Starts with Alcon's violations where you go 24 through labeling? 25 A. Correct. 57 1 Q. On the next couple pages, correct? 2 A. Correct. 3 Q. Your opinions in this case with respect to 4 retreatment rate reporting, is it fair to say, 5 come from Dr. Will's experiences and the Alcon 6 billing document that you've seen and attached as 7 an exhibit to your report? 8 A. I would say mostly the -- well, both, both. I 9 can't say how to weight them, but both, surely. 10 Q. Right. And that's what your opinion is based on, 11 the billing document that you've looked at that 12 shows the numbers of treatments and retreatments 13 for the various entities, and you have them lined 14 up in percentage order at the back of your report, 15 correct -- 16 A. Correct. 17 Q. -- per year? That's the table of lasers with 18 excess retreatments? 19 A. Right. 20 Q. So it's that document and the things that you've 21 read in the various Dr. Will documents about 22 complaints Dr. Will made to Alcon, correct? 23 A. Correct. In relationship to the requirements in 24 the labeling for retreatment that were in the 25 labeling for LadarVision. 58 1 Q. I understand. That's more what you think the 2 obligations are as opposed to what the factual 3 predicate is. 4 A. Gotcha. 5 Q. I'm trying to understand the factual predicate. 6 A. That's fair enough. 7 Q. So for retreatments, just to summarize again, 8 because I don't want to be confused, it's the 9 Alcon billing record that shows the treatments and 10 retreatments that we've talked about and the 11 complaints that Dr. Will made? 12 A. Correct. 13 Q. Okay. And if you turn to page 5 where you're 14 speaking about Alcon violations on page 5, this is 15 all Dr. Will complaints, correct? 16 A. No. 17 Q. It's Dr. Will and -- that was imprecise. This is 18 again the billing document and Dr. Will's 19 complaints? 20 A. Correct. 21 Q. Okay. And if you turn to page 6, I think this is 22 where it's going to be fair to say that everything 23 on page 6 relates to Dr. Will specifically, 24 correct? 25 A. That is correct. 59 1 Q. Okay. If you turn the page 7, everything listed 2 on page 7, would you agree or at least numbers 1 3 through 7 are Dr. Will complaints? 4 A. 1 through 7 are Dr. Will complaints. 5 Q. And Dr.-- strike that. Number 8 is a complaint or 6 a report of visual acuity outcomes by a 7 Dr. Britton, correct? 8 A. Correct. 9 Q. And the document that you use to support that is 10 an email from Dr. Will to Alcon, correct? 11 A. Correct. 12 Q. Not an email from Dr. Britton or any documents 13 from Dr. Britton, correct? 14 A. That's correct. 15 Q. You haven't seen any documents from Dr. Britton, 16 correct? 17 A. Correct. 18 Q. If we turn to page 9 which continues -- page 8 19 which continues on to page 9, this is a summary, 20 at least on page 8, the first set of bullet points 21 summarizes statements made by various doctors in 22 the conference call organized by Dr. Will on 23 October 30th, 2002, correct? 24 A. Correct. 25 Q. Okay. And that's Dr. Sloane -- in addition to 60 1 Dr. Will, Dr. Sloane, Dr. Delaney, Dr. DellaRusso 2 and Dr. Chotiner, correct? 3 A. Correct. 4 Q. And have you reviewed any patient records for 5 Drs. Sloane, DellaRusso, Chotiner or Delaney? 6 A. No, I haven't. Also, it has been mentioned also 7 of Jerry Goodman, Robert Schnipper, and Sheri 8 Rowen. 9 Q. Yes, but -- okay. And let's talk about that. 10 That was -- Drs. Goodman, Schnipper, and Rowen 11 weren't on that call, correct? 12 A. Correct, that's correct. 13 Q. And you've reviewed that transcript, correct? 14 A. Correct. 15 Q. And this was Dr. Chotiner claiming that he had -- 16 A. Correct. 17 Q. -- some information about some other doctors' 18 claims, correct? 19 A. Correct, that is correct. 20 Q. You haven't done anything to speak to doctors -- 21 A. No, no, not at all. 22 Q. -- just let me finish the question, please. 23 A. Oh, sorry. 24 Q. You haven't done anything to speak with 25 Drs. Goodman, Schnipper or Rowen, correct? 61 1 A. Correct -- 2 Q. I'm sorry. 3 A. That's okay. 4 Q. I didn't want to cut you off. And Dr. Rowen is 5 one of the EBW doctors, correct? 6 A. I've heard that that's the case. Let me add that 7 I've also not spoken to any of these doctors, 8 don't know them. I know of them. But I've not 9 spoken with them, so I don't -- 10 Q. And other than Dr. Will, have you seen any 11 correspondence between these non-EBW doctors other 12 than Dr. Rowen and Alcon about their issues? 13 A. No, I have not. 14 Q. So you don't know one way or the other what Alcon 15 did or didn't do to investigate, review, evaluate 16 or analyze their claims, correct? 17 A. That is correct. 18 Q. Okay. And in fact, you don't know what Alcon did 19 or didn't do for Dr. Rowen either, correct? 20 A. That is correct. 21 Q. Because you haven't gotten those documents from 22 EBW? 23 A. Correct. 24 Q. Okay. Then on the sentence that begins at the 25 bottom of page 8, you talk about other users 62 1 reporting what you call adverse events with 2 LadarVision, correct? 3 A. Correct. 4 Q. And then you go through, I think there's eight 5 bullet points, and these are all, would it be fair 6 to say, documents provided to you by Dr. Will 7 which are emails between Dr. Will and these 8 various doctors identifying issues? 9 A. Correct. With the caveat that some of them, and I 10 can't put my finger on which one, were part of a 11 thread of emails on some sort of a -- 12 Q. User list? 13 A. User list that were -- I'm not sure they were all 14 exactly conversations with Dr. Will, but they were 15 part of a chain of conversations that were, that 16 was ongoing. I'm not sure who started the chain. 17 Q. Okay. It's fair to say with respect to these 18 eight -- yeah, with these eight bullet points, you 19 haven't seen any documents between these various 20 physicians and Alcon reporting any of these 21 issues, correct? 22 A. That is correct. 23 Q. You've only seen communications either between 24 them and Dr. Will or communications with a larger 25 group of doctors, correct? 63 1 A. That is correct. 2 Q. All of which were produced by Dr. Will? 3 A. Correct. 4 Q. So you don't know, as with the other doctors, one 5 way or the other what Alcon did or didn't do to 6 investigate, review, analyze any of these 7 complaints, correct? 8 A. That is correct. 9 Q. In fact, you don't know one way or the other 10 whether these doctors, in fact, communicated these 11 complaints to Alcon? 12 A. That is correct. 13 Q. And then you have one other -- 14 A. May I add one comment there? 15 Q. Sure. 16 A. To the extent that I believe that these -- at some 17 point in time, Dr. Will made Alcon aware of these 18 complaints, but I don't know that. In other 19 words, he made -- apparently, I understand that 20 the stream of information that Dr. Will provided 21 me was provided to Alcon at some point or to -- 22 Q. When? 23 A. Yeah, at some point in time. 24 Q. That's what I'm asking you. When? 25 A. I don't know actually to be honest with you, I 64 1 don't know. But that's been my, my understanding, 2 but I don't -- I can't, I couldn't nail it down. 3 Q. So you don't know when, and do I take it that your 4 information comes from Dr. Will? 5 A. That is correct. And I think that that was, if I, 6 memory serves me, I believe there was a conference 7 in Fort Worth at which Dr. Will presented a great 8 deal of information. And I believe that part of 9 that was him talking about other docs that had 10 similar experiences, but I, that's sort of, that's 11 the basis of, that I, sort of surmised that, that, 12 at least some of this information made its way to 13 Alcon, if not directly from these docs, indirectly 14 from Dr. Will at some point in time. It may not 15 have been contemporaneous with the events. I have 16 no idea. 17 Q. Okay. Then if we move on to page 9, you have 18 "Alcon failed to report device failures to FDA," 19 correct? 20 A. Correct. 21 Q. And then, at least on page 9, this all relates to 22 Dr. Will, correct? 23 A. That is correct. 24 Q. And if you turn to page 10, first paragraph 25 relates to Dr. Will, correct? 65 1 A. You mean the paragraph that -- right at the top? 2 The continuation of the previous -- 3 Q. Yes, the continuation paragraph, right. 4 A. Yes. 5 Q. And then the next paragraph relates to the 6 conference call that Dr. Will organized, correct? 7 A. Correct. 8 Q. Then the next paragraph relates again to Dr. Will, 9 correct? 10 A. Correct. 11 Q. If you turn over to page 11, the continuation of 12 that paragraph is Dr. Will, correct? 13 A. That is correct. 14 Q. And then your next paragraph begins with "Gaps in 15 information"? 16 A. Right. 17 Q. And is it fair to summarize that to say you don't 18 have a lot of information about what Alcon did or 19 didn't do, so you're almost reserving your right 20 to say Alcon did or did not comply with its 21 obligation based on other information? 22 A. I'm not sure I would characterize it that way. 23 Basically what I was saying, and I did this in 24 each section because I'm -- I tried to be very 25 meticulous and fair. I knew that I had some 66 1 information that was, raised concerns, but I also 2 knew that I didn't have complete picture because I 3 didn't know what Alcon knew and when Alcon knew 4 it. 5 So I essentially tried to frame out the 6 situation so that if there was exculpatory 7 information. That, in fact, if it came forward, 8 I'd be able to revise my opinion because I, I have 9 a reputation of being somebody who is, doesn't 10 take sides. And I had a great conversation with 11 my daughter about that because I repossessed her 12 car when she was a teenager, and she wasn't happy 13 about that. 14 So I think that -- I'm not sure I agree with 15 your characterization. I was trying to make clear 16 that. Based on the information I have, it looks 17 like there were problems that weren't reported. 18 There were repeated problems that weren't 19 reported. 20 But on the other hand, I acknowledged that I 21 don't have all of the information. And I reserve 22 the right to wait and see what happens. 23 Q. And with respect to the EBW lasers at issue in 24 this case, the 11 lasers, you had access, if you 25 wanted to, to all the complaints, service, and 67 1 maintenance records for those lasers, and you 2 didn't, you didn't get them from EBW, correct? 3 A. Well, I didn't know I had access. I was -- I 4 analyzed the information that was provided to me. 5 Q. I understand. The next section that starts on 6 page 12 is your next opinion which relates to 7 either failures to submit PMA supplements or 8 submission of PMA supplements with incomplete or 9 inaccurate information, correct? 10 A. Correct. 11 Q. Then you state what you believe the FDA 12 requirements are, correct? 13 A. Correct. 14 Q. Then we start with the Alcon violations. That's 15 that one paragraph, and that all relates to 16 Dr. Will, correct? 17 A. Correct. 18 Q. And then again on page 13, you have information 19 gaps where you concede again, as I think you did 20 previously, that it's possible that Alcon did take 21 appropriate actions. You just don't know one way 22 or the other, correct? 23 A. Again, I would -- no, essentially that's a fair 24 statement. 25 Q. Let's read specifically what you say. 68 1 A. Okay. 2 Q. Your first paragraph says, quote "It is possible 3 that Alcon took appropriate actions with regard to 4 some or all of these violations but that their 5 actions are documented in files not yet released 6 to the Plaintiff, such as manufacturing records, 7 PMA supplements, annual reports, and communication 8 with the agency. Correct? 9 A. Correct. 10 Q. Then if you turn to page 14, your third opinion 11 is, "Alcon failed to implement corrective and 12 preventative actions and other quality system 13 requirements in response to complaints, adverse 14 events, MDR reportable events, device failures, 15 and maintenance and repair problems," correct? 16 A. Correct. 17 Q. And then you start out by giving what your view of 18 the FDA requirements are, correct? 19 A. Correct. 20 Q. And then you have an Alcon's violation section, 21 correct? 22 A. Correct. 23 Q. And the Alcon's violation section for this -- all, 24 at least the first paragraph relates to the Alcon 25 billing record, correct? 69 1 A. Not completely. It also relates to Alcon recalls. 2 Q. Okay. So this is -- okay. This is the billing 3 record, and then this is the 2001, 2002 -- the 4 2000 and 2001 recalls? 5 A. Correct. 6 Q. Okay. And then again on page 15, you have an 7 information gaps paragraph, correct? Is that 8 correct? 9 A. Correct. 10 Q. Okay. And then at the bottom is your fourth 11 opinion, and I believe your last opinion, which is 12 "Alcon failed to report off-label uses and, in 13 fact, promoted them," correct? 14 A. Correct. 15 Q. And then you have your requirements that you 16 believe are at issue at the bottom, correct? 17 A. Correct. 18 Q. And then for the violations, this relates to both 19 Dr. Will and the billing record, correct? 20 A. And also -- that's primarily the case. 21 Q. And then the letter you cite in footnote 77? 22 A. Correct. 23 Q. And then your information gap states that quote, 24 "Some uncertainty will exist about what Alcon did 25 and didn't do regarding its obligations to report 70 1 off-label use." Correct? 2 A. Correct. 3 Q. And then you finish up by putting together this 4 table of lasers with excess retreatments, correct? 5 A. Correct. 6 Q. Did you do that on your own or did Dr. Walther or 7 Dr. Ritchie do that? 8 A. I didn't know them at all. 9 Q. So you did this? 10 A. I basically pulled it from the -- 11 Q. From the Alcon billing documents? 12 A. From the Alcon -- just to try to summarize. I 13 didn't want to -- I could have just attached that 14 with little notes, sticky, but this seemed more 15 efficient. 16 Q. You would agree with me that the letters, the 17 '98 -- let's set aside the '98 for now because 18 that was for PRK. I think for LadarVision for 19 LASIK, which is at issue for the 11 EBW lasers in 20 this case, let's focus on the 2000 and the 2002 21 PMA approval letters and conditions of approval; 22 is that fair? 23 A. Sure. That's okay. 24 Q. It's fair to say that expressly in the 2000 or 25 2002 letters or conditions of approval, there's no 71 1 specific statement that the company has to report 2 to FDA retreatment rates in excess of the 3 percentages shown in the clinical trial, correct? 4 A. Correct, in a very narrow sense because there was 5 a reporting requirement any time the -- the 6 retreatment rate exceeds the retreatment rate 7 stated in the labeling. 8 Q. That's because you have interpreted retreatment 9 rates over the retreatment rates from the clinical 10 trial to be some sort of adverse event or device 11 defect, correct? 12 A. That's how it's defined in the regulations. Not 13 my opinion. 14 Q. I just want to understand, your opinion is that 15 retreatment rates above the percentages that came 16 out of the clinical trial are adverse events or 17 device defects attributable to the LadarVision 18 device and need to be reported to FDA, correct? 19 A. Either that or there are off-label uses. In 20 either case, they are reportable. And the reason 21 I say that is because they are, not only are they 22 in the labeling, but they are in the labeling 23 after long discussions in ophthalmic panel 24 discussions about the importance of retreatment 25 rates. 72 1 So I think that -- so my judgment there is 2 not solely based -- you know, it's based on what, 3 as I said in my little prologue to the discussion 4 on retreatment rates, I pointed out that what -- 5 retreatment rates are very important in our 6 approval processes having nothing to do with 7 Alcon, nothing to do with Autonomous. 8 We had lasers that came through with very 9 high retreatment rates, and we wouldn't even let 10 them go to panel. We would not let the company go 11 to panel until they showed us that their 12 retreatment rates were in an acceptable range. So 13 it was an important issue. It was an important 14 issue for the panel. So that's why my judgment 15 was that retreatment rates meant that it wasn't a 16 defective device. 17 Q. Your opinion is that retreatment rates above the 18 percentages listed, percentages coming out of the 19 clinical trials demonstrate that the device is 20 either having adverse events or is defective or 21 are the result of off-label use? 22 A. Correct. 23 Q. And what happened in pre-approval discussions with 24 FDA, unless it makes its way into the approval 25 letter or conditions for approval, it's not a 73 1 specific reporting obligation for the company, 2 correct? 3 A. It did make its way in the sense that in the 4 labeling, it says explicitly, "Retreatment rates 5 are such-and-such." 6 Q. And the labeling that says "Retreatment rates are 7 such-and-such" are reports of the percentages that 8 came out of the clinical trial, correct? 9 A. That is correct. 10 Q. And there are different percentages for myopia 11 than there are for hyperopia and astigmatism; is 12 that correct? 13 A. Absolutely. 14 Q. And if a hypothetical practice shows a billing 15 retreatment rate of 30 percent, is it your view 16 that that needs to be reported to the FDA 17 irrespective of any analysis or evaluation done by 18 the manufacturer on why the rate is as such? Do 19 you understand that? 20 A. That's a complicated question. 21 Q. Okay. Let me break it down for you then. 22 A. Okay. 23 Q. You understand the premise that practice X says, 24 calls up Alcon and says, "I have a 30 percent 25 retreatment rate over the last 6 months and I'm a 74 1 little concerned about it." Okay? Accept that as 2 a premise. 3 A. Absolutely. 4 Q. And then Alcon does work with the physician to 5 figure out why the retreatment rate in and of 6 itself is 30 percent. You understand that? 7 A. Correct. 8 Q. Okay. And Alcon looks at the practice's patient 9 mix to determine whether or not they're treating a 10 lot of hyperopias or a lot of complex cases? 11 A. I agree. 12 Q. Alcon looks at the development of the practice's 13 nomogram to decide whether they need assistance in 14 better developing a nomogram. Okay? 15 A. Okay. 16 Q. And let's say that Alcon then determines that 17 putting in nomogram assistance and understanding 18 where the mix is, that it doesn't appear to be 19 retreatments attributable to the device but 20 retreatments attributable to the practice specific 21 variables that impact retreatment rates. Okay? 22 Let's assume that that's what Alcon determines 23 after reviewing things. Okay? 24 A. That's plausible. 25 Q. I'm not even asking if it's plausible. That's my 75 1 hypothetical. I'm asking you to assume that 2 that's what Alcon does. 3 A. Gotcha. 4 Q. They review everything and make that 5 determination? 6 A. Okay. That's fair. 7 Q. At that point, Alcon doesn't have a reporting 8 obligation for that practice to FDA because 9 they've determined that it's not attributable to 10 the device, correct? 11 A. That is correct. 12 Q. Okay. 13 A. I absolutely agree with you, that is, but I 14 guess -- okay. 15 Q. I mean, that's, Mr. Harris can ask you as many 16 follow-up questions as you want, and I don't want 17 to stifle you, but I think you've answered my 18 question which is based on a hypothetical. Okay? 19 A. Fair enough. 20 Q. Is it fair to say that sitting here today you 21 don't know what Alcon did or didn't report to the 22 FDA in its 2000 through 2004 annual reports for 23 LadarVision? 24 A. That is correct. 25 Q. So you don't know if Alcon complied with its 76 1 obligations to report unscheduled maintenance for 2 '99, 2000, correct? You don't know whether or not 3 that's in the annual reports for '99 and 2000, 4 correct? 5 A. That is correct. I have not looked through the 6 annual reports. 7 Q. And you don't know if Alcon complied with its 8 obligations in its annual reports to provide FDA 9 with information on changes to the device, the 10 device labeling or facilities, correct? You don't 11 know one way or the other? 12 A. With the caveat that if the change, if some of the 13 changes were made, there certainly would have been 14 made in a supplement, some of the changes. And 15 since the supplement doesn't appear on the FDA web 16 site, I assume those changes didn't rise to the 17 level of requiring a PMA supplement. So it's 18 possible that other changes were made to the file 19 that were seen as not needing a supplement. 20 Q. And what you're referencing is the obligation of 21 the manufacturer to do a review and evaluation of 22 changes to determine whether they rise to the 23 level of requiring a PMA supplement, correct? 24 A. That is correct. 25 Q. And you don't know one way or the other with 77 1 respect to these changes whether Alcon did, in 2 fact, do the review and analysis necessary to make 3 that determination? 4 A. That is correct. I would say that the, some of 5 the changes that occurred in response to, as 6 corrective actions, like translators, I would have 7 thought that those changes would have risen to the 8 level of a report. But I have not seen a report, 9 so therefore I, I'm a little concerned that that 10 reporting obligation was not met. Of course, I 11 have no way to know what was going on inside 12 Alcon, so I cannot really -- 13 Q. And at the very least, you would agree with me 14 there are two level of changes that require 15 reporting. That's changes that the company 16 determines rise to the level of requiring a PMA 17 supplement, correct? 18 A. Correct. 19 Q. And then there are changes that don't rise to that 20 level but still get reported in the annual reports 21 to FDA in a list of device changes, correct? 22 A. And then there are other changes. They are 23 intermediate. They can make changes with a 24 30-day -- there are several. Actually, there 25 are -- unfortunately complicated, but there are 78 1 some, there are judgments that the manufacturer 2 has to make, but there are some -- they can submit 3 a document that, to the agency saying that the 4 change is effective by such-and-such a date, and 5 the agency has 30 days to decide that no, you need 6 to submit a supplement or no, that's okay. And do 7 a real time review. So there is a mix of things 8 that can be reported in an earlier time frame. 9 But you're correct that the company makes that 10 decision as to when it rises to that level and -- 11 Q. And so irrespective -- so I think we've 12 established you don't know then what, what Alcon 13 has or hasn't reported to the FDA in annual 14 reports or intermediate reporting? 15 A. That's correct. 16 Q. And I take it it's also fair to say that you 17 haven't seen any documentation whereby FDA has 18 taken any action against Alcon or the LadarVision 19 machine with respect to any submissions made to 20 FDA? 21 A. That is correct. 22 Q. You agree that on its face, and interpretive rules 23 and regulations, the conditions of approval letter 24 and the regulations don't require a manufacturer 25 to report to FDA every single complaint made by a 79 1 user of the device irrespective of the 2 manufacturer's evaluation and determination? 3 A. Absolutely. 4 Q. It's the manufacturer's obligation to do a review 5 and assessment and then only report it if they 6 believe that it meets the regulatory criteria that 7 we talked about earlier, correct? 8 A. That is correct. 9 Q. Are you familiar with Section 803.22 of the CFR 10 which speaks of when not to file MDRs? 11 A. I am. I haven't memorized it, but I'm familiar 12 with it. 13 Q. Let me read you what it says and tell me if that 14 refreshes your recollection. 15 A. Okay. Thanks. 16 Q. 21 CFR Section 803.22B is entitled "When Not To 17 File." And what the regulation says is, quote "A 18 medical device report that would otherwise be 19 required under this section is not required if the 20 user facility, importer or manufacturer determines 21 that the information received is erroneous in that 22 a device-related adverse event did not occur." 23 Does that fresh your recollection as to that 24 subsection? 25 A. Sure, sure. I just can't attach them to letters 80 1 and numbers like most lawyers can. 2 Q. I understand. I can't do it, either. I have the 3 benefit of a colleague writing it in an outline 4 for me. 5 Would it, would you agree with me then to the 6 extent that Alcon determined for Dr. Will that his 7 complaints were erroneous in that a device-related 8 adverse event did not occur, then under the 9 section I just read, Alcon would not have to file 10 MDRs? 11 A. If that was the determination. I have no idea if 12 that was the determination or not. 13 Q. Okay. So if Alcon in the lengthy exchanges they 14 had with Dr. Will over the years leading up to the 15 judgment against Dr. Will and the lawsuit against 16 him, if that's what Alcon determined, you would 17 agree that this section would require them not to 18 file an MDR? 19 A. That is correct. That would be the correct way to 20 handle that. 21 Q. Are you familiar with -- and we'll go through the 22 same little exercise. 21 CFR Section 820.198(a)3? 23 And if so, tell me from memory. Let me -- 24 A. I'm familiar with it, but I don't know it by 25 memory. 81 1 Q. Let me read it to you and see if this refreshes 2 your recollection. 3 A. Sure. 4 Q. It says, quote "Complaints are evaluated to 5 determine whether the complaint represents an 6 event which is required to be reported to FDA 7 under part 803 or 804 of this chapter Medical 8 Device Reporting." 9 It's the general catch-all for what the -- 10 A. Absolutely. 11 Q. And what that says is what we talked about 12 earlier. I'm putting a regulation to it. 13 A. Sure. 14 Q. These are the evaluations that the manufacturer 15 has to do. That's their obligation? 16 A. That is correct. 17 Q. And again, you don't know what Alcon did or didn't 18 do in response to Dr. Will's complaints other than 19 what you've seen from Dr. Will? 20 A. That is correct. With the caveat that everything 21 I've read and heard so far leads me to believe 22 that for some reason, either Autonomous and its 23 subsequent entities did not define a retreatment 24 rate in excess of what's in the label as an 25 adverse event, and therefore, apparently did not 82 1 report it. 2 And so I agree that that's the rule and Alcon 3 has the right and obligation to make that 4 decision. I guess my view is I'm surprised that 5 apparently it wasn't part of that routine 6 apparently. 7 But I don't know that for a fact. I only 8 know it from what material I have. And that's why 9 I have the other caveat in there to say, look, if 10 you have other information that says, provides a 11 reason why each manufacturer is supposed to have 12 an explanation of why they did not consider that 13 an adverse event. And perhaps Alcon has that 14 exculpatory type of explanation. That would be 15 great, you know, I mean from my personal point of 16 view. I'm not so sure my client would be so 17 excited about that. 18 Q. Again, the information that you had was the 19 documents Dr. Will provided you, the conversations 20 with Dr. Will, and the Alcon billing document? 21 A. Correct. 22 Q. Are you familiar -- and we'll go through the same 23 thing -- the next subsection under the same CFR 24 which is 820.198(b), which says quote, "Each 25 manufacturer shall review and evaluate all 83 1 complaints to determine whether an investigation 2 is necessary. When no investigation is made, the 3 manufacturer shall maintain a record that includes 4 the reason no investigation was made and the name 5 of the individual responsible for the decision not 6 to investigate"? 7 A. Correct. 8 Q. Okay. And that's the obligation that Alcon has, 9 just like any other device manufacturer with 10 respect to complaints? 11 A. Correct. 12 Q. And the event becomes reportable under 820.198 13 only if the company's evaluation determines that 14 the event is reportable? 15 A. Absolutely. Right. 16 Q. Are you familiar with Section 803.20(c)2 which 17 says, in essence, "A company doesn't have to 18 report an event that may on its surface appear 19 reportable if, quote, 'a person who is qualified 20 to make a medical judgment, for example, a 21 physician, a nurse or risk manager or biomedical 22 engineer reaches a reasonable conclusion that a 23 device did not cause or contribute to a death or 24 serious injury.'"? 25 A. Sure. 84 1 Q. And again, that's the manufacturer's obligation to 2 do an evaluation and make that determination? 3 A. Right. I agree. 4 Q. And you agree that MDR reporting only relates to 5 death or serious injury to a patient or an event 6 that could likely lead to death or serious injury 7 to a patient in the future? 8 A. Correct. 9 (Whereupon Plaintiff's Waxler Exhibit 10 Number 6, was marked for identification.) 11 Q. (BY MR. BROWN) I'm showing you what I've marked as 12 Waxler 6 which is a document produced by Dr. Will 13 in response to a subpoena for his attendance at 14 deposition which is Bates Number Will 191 through 15 216. Have you seen this document before? 16 A. It looks familiar. 17 Q. Are you familiar generally with Dr. Will making an 18 official complaint, an attachment to the FDA in 19 January of 2004? 20 A. I've seen this document, but I don't know that I 21 knew it, you know, that it was part of a 22 complaint. I mean, I, yeah. I mean, it looks 23 familiar, and I read it. 24 Q. Okay. What is your understanding of FDA's 25 practice and procedures with respect to 85 1 investigating a complaint of this sort by a user 2 of a device that submits detailed information 3 about alleged device defects and adverse events? 4 What's FDA do? 5 A. FDA investigates. 6 Q. And how does FDA investigate? 7 A. Well, this went to the, you know, FDA has -- 8 Q. This went to the Office of Compliance at the FDA? 9 A. The Office of Compliance in FDA, not to the Office 10 of Compliance within CDRH. I would assume that 11 the, that these two fellows -- and I don't know 12 them personally -- but I assume that that office 13 would then refer it to the CDRH Office of 14 Compliance, and then it would go to the branch 15 that deals with ophthalmic devices. And then that 16 branch and the office of compliance at CDRH would 17 contact Everett Beers, who is my successor and 18 branch chief in optics or lasers and other objects 19 like that, and they would discuss it and decide a 20 course of investigation. I would assume they 21 would, they would initiate some, some 22 investigation. 23 Q. And in your conversations with Dr. Will, did he 24 advise you that he's had interaction with the FDA 25 on these allegations about LadarVision? 86 1 A. That is correct. 2 Q. And do you have an understanding that FDA has 3 taken no action against Alcon to present with 4 respect to any of Dr. Will's complaints or any 5 other complaints against LadarVision? 6 A. I don't know that they've taken any action or not. 7 I have not seen anything that confirms or denies 8 any action. 9 Q. And if I represent to you, for purposes of whether 10 it would change your opinion, if I represent to 11 you that FDA has received all of Dr. Will's 12 complaints and allegations, the same ones you have 13 looked at and has, in fact, investigated and has 14 not taken any action against LadarVision, how 15 would that affect the opinion that you're offering 16 with respect to the LadarVision machine? 17 A. Not much. Because, and I don't mean this to be in 18 any way casting aspersions on my dear friends, but 19 this report is January 2004 to Office of 20 Compliance. There is FDA time and then there is 21 folks outside the agency's time. That's a 22 fairly -- it may seem like a long time between 23 January 31st and now, but that's a fairly short 24 time given the staff at FDA. 25 And the fact that they transmitted that 87 1 information down through several levels and 2 someone had to actually go and look at the 3 information. So I don't know where in the process 4 that investigation is -- if they could have 5 decided not to investigate. They could have 6 decided this warrants a complete investigation and 7 send in a team to Alcon. I have no idea where in 8 that process. 9 But it takes, I've even seen simple cases 10 that take a year, 18 months, unless there's a 11 death involved, you know, unless someone went 12 blind and they had an actual event, they would, 13 they'd, ordinarily wouldn't go out, and you know, 14 have a sort of quick reaction team. 15 So I'm not surprised that I don't see 16 anything, but it could mean that they haven't, 17 they've decided that this is an unwarranted 18 allegation, so they could have decided that we 19 need to look at it more. I have no idea what's 20 going on. 21 Q. And if FDA decided that it was, that Dr. Will's 22 complaints were unwarranted, would that change 23 your opinion? 24 A. Oh, of course, sure. I would look at it and see 25 what they said. I mean, I'd take any information 88 1 that people provide. 2 Q. But you don't disagree with me that at the present 3 time, it's FDA's obligation to make decisions with 4 respect to the safety, the continuing safety and 5 efficacy of medical devices like LadarVision, 6 correct? 7 A. Absolutely. 8 Q. And so if FDA investigates complaints made by 9 Dr. Will and came to a decision that no action was 10 necessary or they were unwarranted, then that 11 would change the opinions that you're offering in 12 this case about LadarVision, correct? 13 A. Sure. 14 (Whereupon Plaintiff's Waxler Exhibit 15 Number 7, was marked for identification.) 16 MR. BROWN: Let's mark this as Waxler 7. 17 Q. (BY MR. BROWN) I've handed you what I've marked as 18 Waxler 7, which is another document produced by 19 Dr. Will, Bates Numbered Will 278 through 285 20 which is an April 20th, 2004 letter from 21 Dr. Will to Everett Beers, your successor as the 22 chief of CDRH for the FDA. Are you familiar with 23 this document? 24 A. Yes, I am. 25 Q. And as with the prior document we looked at, this 89 1 certainly confirms that it's on, it was made, that 2 Dr. Will made this aware to CDRH for purposes of 3 an investigation if necessary? 4 A. That's correct. 5 Q. And I guess since this is a continuation of the 6 same complaints, your opinion would be the same 7 that if FDA investigated Dr. Will's complaints and 8 allegations and determined that they were 9 unwarranted and no action was necessary, that 10 would change your opinion in this case, correct? 11 A. It would certainly modify it to -- I'd have to 12 modify based on the facts. I deal with the facts. 13 Q. I take it you know Dr. Beers? 14 A. Oh, yes, yes. 15 Q. Worked with him a long time when you were at FDA? 16 A. Oh, yeah. 17 Q. He took over for you as chief of CDRH; is that 18 correct? 19 A. Chief of the branch. 20 Q. Of the branch that -- 21 A. Diagnostic and surgical devices. 22 Q. That is more precise, correct. Have you spoken to 23 Dr. Beers about allegations of defects with 24 LadarVision? 25 A. Absolutely not. 90 1 Q. Are you aware that Dr. Beers has stated, and I'll 2 represent to you -- strike that. Would you be 3 surprised to learn that Dr. Beers has stated 4 publicly that FDA does not consider any particular 5 retreatment rate to be problematic or a device 6 defect unless accompanied with retreatments are a 7 loss of best corrective visual acuity for a 8 patient? 9 A. I would be surprised. 10 Q. You would be surprised? 11 A. I would be surprised. 12 Q. If that, if you learn that that was FDA's current 13 position with respect to retreatment rates as 14 adverse events or device defects, would that 15 change your opinion in this case? 16 A. No. 17 Q. Your opinion would be you disagree with what FDA's 18 current administration views as an adverse event 19 or a device defect, correct? 20 A. That is correct. I don't, I would not believe 21 that that view is consistent with my understanding 22 of the ophthalmic devices panel and the labeling 23 that we wrote when we wrote those. 24 Q. I understand. But if that was the chief of CDRH's 25 view on this as the regulatory authority 91 1 regulating this device, you would just disagree 2 with FDA's current view on that, correct? 3 A. That is correct. 4 Q. You agree that Dr. Beers is the authority on that 5 issue for FDA currently, correct? 6 A. That is correct. He's the regulatory authority on 7 that issue. 8 Q. Correct. The regulatory authority -- 9 A. That is correct. 10 Q. -- charged by the United States Government with 11 regulating LadarVision used in practices with 12 patients, correct? 13 A. Correct. 14 Q. I take it that it's fair to say that you haven't 15 had a discussion with Dr. Will about the many 16 variables that come into play in determining what 17 any particular practice's retreatment rate will 18 be? 19 A. Well, I know it from fundamentals. I mean, I've 20 been doing this for quite a while so -- I mean, I 21 know there are a lot of variables that go into 22 retreatment. 23 Q. Do you agree that the, what an actual retreatment 24 rate is for purposes of determining whether or not 25 there is a problem even in your view is patient X 92 1 treated with LadarVision number 1 by Dr. Smith and 2 then retreated by Dr. Smith on the same device? 3 A. That's one way of doing it. That's one way of 4 defining it, sure. 5 Q. Okay. But that's, you agree with the general 6 premise that the only clinically relevant 7 retreatment numbers to consider in a retreatment 8 analysis would be the same patient being treated 9 by the same doctor on the same LadarVision 10 machine, correct? 11 A. Well, you can have a more comprehensive measure 12 that in a way confounds who did the retreatment of 13 the -- you still have a retreatment rate. I know 14 you make a distinction between those that are -- I 15 mean, there are various reasons for retreating. 16 You are absolutely correct. So that knowing what 17 went into the retreatment of that particular case 18 is very important. 19 But if you want an overall average of 20 retreatment rate, then you can get that in other 21 ways as well, getting a cumulative average which 22 is often does. But certainly if you want a 23 detailed understanding of why those retreatments 24 occurred, you need to have that kind of patient 25 was treated, then they were retreated, and then, 93 1 to know what the conditions were for that patient. 2 Q. Okay. 3 A. Way I understand them. 4 Q. I think we're talking the same language with 5 respect to looking at why a particular patient was 6 retreated using the same LadarVision machine? 7 A. Correct. 8 Q. And a retreatment that may be in billing records 9 that shouldn't be in an actual retreatment rate, I 10 think you'd agree with me, would be a patient that 11 was treated initially on a Visx machine and then 12 enhanced using a LadarVision machine, correct? 13 A. Oh, sure, of course. 14 Q. That shouldn't be quote "counted" against the 15 LadarVision's retreatment rate, correct? 16 A. Yeah, sure, that's correct. 17 Q. And you understand that there are those treatments 18 in the billing document because those are billing 19 documents for how much Alcon is going to charge a 20 particular user based on whether it was a 21 treatment or a retreatment? 22 A. That is correct. 23 Q. And you understand that many practices have 24 multiple lasers, correct? 25 A. Correct. 94 1 Q. And that they use -- 2 A. I know some. I have no idea -- 3 Q. Some or however many, you understand at the very 4 least that exists that some practitioners -- 5 A. Right. 6 Q. -- treat initially on a non-LadarVision machine 7 and then retreat on a LadarVision machine, 8 correct? 9 A. Right, correct. 10 Q. Do you have an understanding why doctors prefer to 11 do retreatments on a LadarVision machine that may 12 have been done on other manufacturers' machines? 13 A. I can only surmise. I mean, I don't -- 14 Q. I don't want you to speculate. I just want to 15 know if you have an understanding. 16 A. I don't really. I mean, I don't know even if 17 that's correct or not. 18 Q. Have you done any study or analysis regarding what 19 the actual retreatments rates were for any of the 20 11 EBW lasers? Other than what you've seen in the 21 Alcon billing documents? 22 A. What do you mean by actual retreatment rate? 23 Q. What we talked about being actual, being the same 24 patient being treated and retreated on the same 25 laser. 95 1 A. No. 2 Q. You've just looked at the Alcon billing record, 3 correct? 4 A. Right. I mean, the overall outcome is kind of the 5 footprint of what's been, what's happened. 6 Q. Would you agree with me generally that there's no 7 FDA requirement that a company conduct a recall 8 unless it's ordered to do so by FDA? 9 A. Most -- they're under no obligation to. That is 10 correct. Typically, most recalls are voluntary, 11 so-called voluntary. Sometimes there's jawboning 12 behind the scenes, having done that before. 13 Q. Right. And what you're talking about is the 14 company does a voluntary recall or a voluntary 15 field corrective action after having a dialogue 16 with FDA about the issue? 17 A. Right, and sometimes they don't have a dialogue, 18 but sometimes they do. 19 Q. And do you know one way or the other whether Alcon 20 had a prevoluntary recall discussion with FDA for 21 either the 2000 or 2001 recall? 22 A. I have no idea. Wouldn't have any way of knowing. 23 Q. Okay. It's fair to say that you don't know one 24 way or the other whether Alcon provided recall 25 notification to users of LadarVision implicated by 96 1 the 2000 and 2001 recalls? 2 A. That is correct. 3 Q. Once the recall is completed by the company, 4 whether it's ordered by FDA, which I think is a 5 rarity, or it's voluntary, which is the much more 6 common practice, FDA will then advise the company 7 it's evaluated the recall and made the 8 determination as to whether or not it was an 9 acceptable response by the company, correct? 10 A. That is correct. 11 Q. And if FDA has any concerns about implementation 12 of the recall on any level, it has a dialogue with 13 the company about that; is that correct? 14 A. That is correct. 15 Q. And can take action against the company with 16 either requiring further recall action or 17 declaring the recall closed, correct? 18 A. Correct. 19 Q. Do you know one way or the other what the dialogue 20 between FDA and Alcon was to close out the 2000 21 and 2002 recalls? 22 A. I have no idea at all. 23 Q. Do you have an understanding that with medical 24 devices like the LadarVision, off-label use is 25 subject to the practice of medicine exception? 97 1 A. That is correct. 2 Q. And your opinions in your report with respect to 3 off-label use stem from the reporting obligation 4 that you see in one of the letters to report to 5 FDA knowledge of off-label use, correct? 6 A. Say that again? 7 Q. Sure. That was a poorly worded question. Do you 8 have an understanding that Dr. Will was engaging 9 in off-label use of LadarVision? 10 A. No. I have no knowledge of -- 11 Q. Do you believe that there's anything unethical for 12 medical practitioners to engage in off-label use 13 of LadarVision? 14 A. That's a good question. I wouldn't say so. I 15 think that's part of the fabric of FDA's, the 16 rules regarding the, rules regarding the practice 17 of medicine and the decision some time ago to, not 18 only with devices, but with drugs, to allow 19 physicians the freedom to prescribe a product 20 based on their professional knowledge. 21 So I think there's always been that, that 22 caveat so to speak in the rules, with the 23 understanding that the -- fortunately or 24 unfortunately -- the manufacturer is still on the 25 hook if they annually count that off-label use or 98 1 if they know about a particular off-label use that 2 is problematic, and they're not reporting it. 3 So -- 4 Q. Do you, do you have an understanding of whether 5 device tampering as defined by the regulations and 6 statutes is a criminal offense? 7 A. Yes, it is. 8 Q. And it's a criminal offense by the doctor who 9 would engage in that device tampering? 10 A. That is correct. 11 Q. And the device tampering, does that lead to, on 12 its face, the device being deemed unadulterated? 13 A. That it is deemed adulterated. 14 Q. Deemed adulterated. 15 A. Yes, that's correct. 16 Q. Do you have an understanding one way or the other 17 whether what Dr. Will and his laser technician, 18 Joe Beasley, were doing with respect to their 19 Alcon LadarVision lasers at the time they had them 20 in their practice was device tampering? 21 A. The information I've been provided by Dr. Will 22 says that he did that with the understanding of 23 Alcon service technicians. 24 Q. Not my question. 25 A. But I have no independent knowledge. 99 1 Q. That's not my question, though. My question is 2 not what Dr. Will told you about what Alcon knew 3 or didn't know about Dr. Will's view. 4 It was, have you drawn any conclusions about 5 any of the things that Dr. Will and his service 6 technician did to the laser to determine whether 7 or not in your view that constitutes device 8 tampering? 9 A. No, I have not, because I don't have enough 10 information to know -- you know, I knew there were 11 some things that went on with regard to the 12 device, but I do not know onto whose authority 13 those changes or things were done. Certainly, I 14 don't have any information to make that judgment 15 so I haven't. 16 Q. Okay. And if you learned that what Dr. Will and 17 Joe Beasley were doing constituted device 18 tampering, do you believe -- would it then be your 19 opinion that Dr. Will and Mr. Beasley committed a 20 crime? 21 A. If that were the facts, then I would have to 22 conclude or make that conclusion. 23 Q. With respect to how the clinical trials for PMA 24 approval are run and supervised, do you agree that 25 devices that are used during the clinical trials, 100 1 there is close attention paid to ensure that all 2 instructions for use are closely followed and 3 adhered to? 4 A. Correct. 5 Q. And have you reviewed any of Dr. Will's patient 6 data or surgical reports for any of the patients 7 who he alleges appear with induced astigmatism 8 after the procedures? 9 A. No, I have not. 10 Q. So you can't confirm or offer an opinion one way 11 or another there are any surgeries Dr. Will 12 operated the LadarVision consistent with the 13 manual and all approved labeling? 14 A. Of course not. 15 Q. And you also have no information as to whether 16 Dr. Will strictly operated the system in 17 accordance with the user specifications, correct? 18 A. That is correct. 19 Q. So if you turn to page 6 of your report. In 20 essence -- tell me if you agree -- a summary of 21 your claim about induced astigmatism or induced 22 cylinder is that Dr. Will's 6 percent rate of 23 induced astigmatism is an MDR reportable event 24 because it exceeds the expected rate for induced 25 astigmatism of greater than 2 diopters at 0 101 1 percent. Is that pretty accurate? 2 A. That's the fourth line? 3 Q. Yes. 4 A. Okay. Yeah, that's what it says here, yeah. 5 Q. And that's based solely on what you've viewed 6 Dr. Will's allegations to be, correct? 7 A. Actually, it's based on Dr. Potvin's analysis of 8 Dr. Will's data. 9 Q. Of what Dr. Will provided to -- 10 A. Oh, yeah. Absolutely. Sure. Of course. 11 Q. Are you aware that Dr. Will testified at his 12 deposition in this case that his optimized -- 13 strike that. You understand optimized techniques 14 is something that Dr. Will has alleged to Alcon 15 throughout a lot of his papers, that he came up 16 with optimized techniques for operating 17 LadarVision? 18 A. Yes. 19 Q. And that this made up a big basis for a lot of the 20 complaints that Dr. Will was making throughout the 21 years, correct? Without trying to quantify it or 22 characterize it, you understand that? 23 A. It certainly was an element, and I'm not sure 24 where the word "optimizing" came from. 25 Q. I'll represent to you that it comes from Dr. Will, 102 1 and that's what he's called it. So for purposes 2 of these questions, assume that it's Dr. Will's 3 language. 4 A. Okay. 5 Q. Do you have an understanding that when Dr. Will 6 was suggesting that Alcon implement changes to 7 adopt his optimized techniques, he was also asking 8 Alcon to pay him money or relief debt that he owed 9 to Alcon? 10 A. I'm aware of that, yes. 11 Q. Okay. Are you aware that he testified at his 12 deposition that quote, "I cannot say for certain 13 whether any of the optimization techniques that 14 were approved in our practice would have had 15 effect on any other LadarVision system anywhere in 16 the world." Close quote. And that's at page 35, 17 line 17 to 20. Are you aware of that? 18 A. No. 19 Q. Does that change your opinion in any way about his 20 optimization techniques? As applied to -- 21 A. No, and I really don't have an opinion about that. 22 Q. Do you know whether optics were replaced on any of 23 the 11 EBW lasers in this case? 24 A. I know nothing about the EBW lasers. 25 Q. Do you know whether the total energy output was 103 1 increased on any of the EBW lasers? 2 A. I -- not on the EBW lasers, no. 3 Q. Do you know if -- strike that. I only have one 4 copy of these, so we're going to mark my 5 highlighted version. 6 (Whereupon Plaintiff's Waxler Exhibit 7 Number 8, was marked for identification.) 8 Q. (BY MR. BROWN) Dr. Waxler, you're going to have 9 to bear with me. We're going to have to work 10 together on this one. It's my only copy. I'm 11 going to have to come around. What I've marked as 12 Waxler 8, this is the October 10th, 1996 IDE 13 Application Guidance for PRK, correct? 14 A. Correct. 15 Q. And you were involved in the process of putting 16 this together, correct? 17 A. Correct. 18 Q. And on the first page, you're identified as the 19 person to whom questions or requests for guidance 20 should contact? 21 A. Correct. 22 Q. Turn to page 7 of this document. Section 3.2.3.2 23 of this guidance that you put out is titled 24 Retreatment Procedures, correct? 25 A. Uh-huh. 104 1 Q. Is that yes? 2 A. Yes, that's correct. 3 Q. Okay. And what you state in this document and 4 what in effect FDA states in this document is 5 quote, "Retreatments done to improve refractive 6 outcome are not necessarily considered treatment 7 failures. However, the number of retreatments 8 planned for refractive purposes should be stated 9 in the protocol and in the informed consent. 10 Retreatments done to achieve resolution of an 11 adverse event are considered treatment failures. 12 A separate and complete analysis of the data for 13 retreatment population should be submitted." 14 Did I read that correctly? 15 A. Correct. 16 Q. And do you agree with that, even today, with 17 respect to retreatment procedures? 18 A. I agree, but there's a caveat, and that is that 19 this -- you have to understand, the reason for 20 this, this is a guidance for the IDE, and the 21 reason for including this was because we didn't 22 want the count, I mean if -- remember the data 23 that's involved in this document, and it's still 24 true today. 25 Q. 1996. 105 1 A. That we were confronted with the situation where 2 some of the companies, some of the manufacturers 3 and some of the docs frankly wanted to treat 4 higher degrees of myopia, and they wanted to be 5 able to treat the higher ones by having a -- they 6 didn't know if they could achieve the entire 7 effect with the first treatment. So we put in a 8 statement saying that it wouldn't be considered a 9 treatment failure if you had to treat a second 10 time simply to reach your goal of, of your 11 effective outcome for the refraction. 12 And so that's why we also included the next 13 part of that statement which said that if the 14 retreatment was done to correct an outcome that 15 wasn't planned, in other words, if you planned to 16 treat 8 diopters of myopia and you only got 6 and 17 you had to treat again, that would be considered a 18 treatment failure. Or if, for example, the person 19 had a bad outcome, that would be considered a 20 treatment failure. So we made sure that we were 21 fair to the companies, and this had nothing to do 22 with Alcon, long before Alcon. 23 Q. This applied to LASIK surgery, to laser surgery in 24 general? 25 A. In general, exactly. 106 1 Q. If you turn to page 11? 2 A. Yeah. 3 Q. Where 3.2.6 and .1 and .2 subsections under it, 4 this lists adverse events and complications, 5 correct? 6 A. Correct. 7 Q. And under 3.2.6.1 is the adverse events listed, 8 correct? 9 A. Correct. 10 Q. And retreatments aren't listed there, correct? 11 A. That is correct. 12 Q. And that would be the same for complications. It 13 doesn't list retreatments as a complication? 14 A. That is correct, because again, remember that the 15 rule is that any event that occurs above the 16 frequency that is expected is an adverse event, so 17 we didn't -- we typically do not list -- I say 18 "we." I still identify myself with the FDA -- 19 that we did not list and still do not list all 20 things that could occur. So that's why the 21 company has the responsibility to make that 22 decision as you said earlier. 23 Q. Exactly. 24 MR. BROWN: Mark this as Waxler 9. 25 (Whereupon Plaintiff's Waxler Exhibit 107 1 Number 9, was marked for identification.) 2 Q. (BY MR. BROWN) I've handed you what I've marked 3 as Waxler 9. Are you familiar with this document, 4 the Alcon bill document? 5 A. I am. 6 Q. And this is a document on which you've based your 7 retreatment rate analysis, correct? 8 A. Correct. 9 Q. I just wanted that -- frankly, just wanted to have 10 a clean copy easily accessible since it's buried 11 in your appendix. If you give me a moment, I may 12 be, I may be done. 13 (Whereupon a recess was held from 11:06 14 a.m. until 11:10 a.m. that was not 15 reported.) 16 MR. BROWN: That's all I have. Thank you, 17 sir. 18 MR. HARRIS: All right. 19 EXAMINATION BY MR. HARRIS 20 Q. Everybody ready? 21 A. I'm ready. 22 Q. Dr. Waxler, given the lack of FDA action so far in 23 the LadarVision machine, may we assume then that 24 it's at least as safe as Vioxx? 25 MR. BROWN: Objection to the form. It's a 108 1 completely improper question -- 2 THE WITNESS: I can't answer that question. 3 MR. BROWN: And even Dr. Waxler won't honor 4 that question with a response because he's a 5 professional. 6 Q. (BY MR. HARRIS) Now, you were present; were you 7 not, during the testimony of Dr. Rick Potvin down 8 in Orlando, Florida? 9 A. I was. 10 Q. And do you recall his testimony that he from time 11 to time did statistics for Alcon regarding 12 treatment and retreatment rates? 13 MR. BROWN: Objection to the form. 14 THE WITNESS: That's correct. 15 Q. (BY MR. HARRIS) Do you recall his testimony that, 16 that he was not aware that Alcon kept any overall 17 retreatment rates for machines in a given year 18 throughout the United States and that sort of 19 thing? Did you hear that testimony? 20 MR. BROWN: And just for the record, 21 Dr. Waxler -- 22 THE WITNESS: Sorry. 23 MR. BROWN: Just give me one second to put in 24 an objection. Thank you. Objection to the form. 25 Q. (BY MR. HARRIS) You heard that testimony? 109 1 A. That is correct. 2 Q. And would you expect a man in his position to be 3 familiar with whether or not the company kept 4 statistics? 5 MR. BROWN: Objection to the form. 6 Foundation. 7 THE WITNESS: I would. 8 Q. (BY MR. HARRIS) And did you hear that same 9 testimony from Mr. Chet Osborn that he was not 10 aware if the company kept statistics of treatment 11 and retreatment rates of all machines from year to 12 year? 13 MR. BROWN: Objection to the form. 14 THE WITNESS: Yes, I remember that. 15 Q. (BY MR. HARRIS) And were you, would you be 16 surprised that the head of technical services in 17 charge of all the maintenance for all the 18 Autonomous machines in the United States would not 19 be aware of any statistics? 20 MR. BROWN: Objection to the form. 21 THE WITNESS: I am. 22 Q. (BY MR. HARRIS) If it proves to be true that 23 Alcon doesn't even keep statistics showing the 24 treatment and retreatment rates from year, from 25 year to year for machines in the United States, 110 1 would that be a problem, sir? 2 MR. BROWN: Objection to the form. 3 THE WITNESS: In my view, yes. 4 Q. (BY MR. HARRIS) And why would that be? 5 A. Be for, the reasons being that retreatment rates, 6 as I said earlier are, were, and as far as I'm 7 concerned, were always an issue in LASIK because 8 of the concern for several reasons, basically, and 9 if you go back through the history of this, this 10 device area, the -- there was always concern with 11 the outcome of a second, of a second treatment. 12 And FDA had very little data on outcomes after 13 retreatments, and so therefore, didn't know if 14 outcomes after second retreatments were as safe 15 and effective as first treatment, so therefore, 16 really made an effort to make sure that the 17 algorithm and the nomograms were established very 18 accurately to begin with so that, in fact, you 19 achieved the correction that you intended to 20 achieve as closely as possible. 21 In fact, if you go back to the record and 22 read the transcripts, and I was there personally 23 and had to review them, the Emory group went, 24 Emory, I forget what the name is in Atlanta, Emory 25 Vision Correction Center there, they went through 111 1 many, many efforts with their original Summit 2 machine to demonstrate that they could approximate 3 a very close outcome to reduce the retreatment 4 rate to a very low number. So that folks made 5 every effort to keep those retreatment rates as 6 low as possible. 7 Recognizing that the state of the art might 8 be as I learned subsequently that retreatments 9 were necessary; that, for certain other more 10 complicated procedures. That that, given the 11 nature of the beast, that you couldn't do the 12 treatment. If you had a, somebody with a 13 12-degree myopia that folks generally couldn't do 14 it with one treatment, so you had to do a planned 15 retreatment. So there was a lot of understanding 16 of the need to keep the retreatment rates as low 17 as practically possible and to define those 18 explicitly in clinical trials. 19 Q. And can that 10.5 percent retreatment rate that's 20 been referred to here be found directly in the 21 labeling of the machine as is licensed by the FDA? 22 MR. BROWN: Objection to the form. 23 Mischaracterization. 24 THE WITNESS: It is in the labeling. 25 Q. (BY MR. HARRIS) And would you explain what that 112 1 means? 2 A. It means that the, that this is a requirement for 3 the company, that this is part of the -- it sets 4 the baseline for reporting. It sets the baseline 5 for recordkeeping, so that when those values are 6 exceeded, there are requirements. 7 It is the company's responsibility to make 8 sure that, that, to explore what the, why those 9 retreatment rates occurred and to report them and 10 at the very least record them, keep track of them, 11 and to know what other sequela, if any, occurred 12 and the consequence of those retreatments. 13 Q. And assume for me that the, for purposes of this 14 question that the, that the Autonomous LadarVision 15 system had come in at a 12 percent or perhaps a 16 13 percent retreatment rate. Let's try 12 first. 17 Would we have to speculate as to what would have 18 happened to the Autonomous machine or do you know? 19 And how do you know if you know? 20 MR. BROWN: Objection to the form. Calls for 21 speculation. Foundation. 22 THE WITNESS: For myopia, we have to be 23 specific for a particular -- 24 Q. (BY MR. HARRIS) Right. 25 A. -- kinds of refractive corrections. For myopia, 113 1 my experience when we saw lasers that came in to 2 us for approval for evaluation that had 3 retreatment rates much in excess of 10 percent, we 4 were very concerned. Especially if they got up 5 into the low teens. And certainly if they got up 6 much higher than that. 7 So I wasn't there for the decisions with 8 regard to hyperopia and other more complicated 9 corrections, so I, I'm not privy to the 10 conversations that led to a higher retreatment 11 rate allowable for those. But for myopia, I know 12 personal firsthand that there were lasers that 13 came in with retreatment rates in those early, the 14 low teens that we said to the company, go back, 15 demonstrate to us that you can have a better, have 16 an algorithm that produces a retreatment rate that 17 is, has a closer fit between the intended versus 18 achieved outcomes. 19 Q. And based on your knowledge and experience with 20 the FDA, if Alcon had, in fact, reported yearly 21 retreatment rates of above .10 -- above 22 10.5 percent, would that have created an 23 investigation inside of FDA of why that was true? 24 MR. BROWN: Objection to the form. Improper 25 question. Calls for speculation. 114 1 THE WITNESS: To be honest, I don't know. I 2 think that -- a lot of deference is given to the 3 company to make those decisions as to how to 4 investigate. I think that there probably -- it's 5 almost hard to secondguess your colleagues. 6 I can only say that I had been there knowing 7 that we had spent so much time emphasizing a low 8 retreatment rate, I would have recommended that we 9 ask some further questions as to why those 10 retreatment rates exceed the retreatment rates 11 that were approved. I can only say what I would 12 have recommended if I had still been there, and 13 it's basically because that's what we had agreed 14 to as a group as the criteria for approval, so 15 they should have been the criteria for remaining 16 on the market. And that's my personal approach to 17 it, so I can't speak for how others would have 18 handled that information. 19 Q. And what, if anything, about going over a 20 10.5 percent retreatment rate would indicate a 21 problem? 22 MR. BROWN: Objection to the form. 23 THE WITNESS: Well, if you're going over a 24 10.5, it's not that the world is going to fall 25 apart. But on the other hand, it seems to me 115 1 that, if that was a typical, if it was typically 2 over that amount, if it was typically 12 or 13 or 3 14 or 30, it would raise questions as to why the, 4 if this is correct, why the intended outcome, why 5 the achieved was not closer to the intended. 6 That's -- because that's the whole point of 7 the laser -- the raison d'etre for this laser 8 should go in and you come out with vision that is 9 closer to being able to see 20/20, closer to be 10 able to get the corrected vision that you planned 11 to correct with the caveat that if you didn't plan 12 to correct it, of course, then that doesn't 13 really --you can subtract that. So there are 14 going to be those cases that were planned 15 correction, but some of those, the biggest concern 16 I have frankly is that, I know that there are 17 overcorrections that require retreatment. How 18 many of those, I have no idea. But that, that 19 number of 10.5 represented undercorrections. You 20 have to remember when you look at that section in 21 the labeling, it says "10.5 due to 22 undercorrections." 23 So when you have a higher rate of overall, 24 gross number, the overall average number of 11 or 25 12 or 15 or 30, you know, maybe it represents only 116 1 undercorrections, but maybe it represents 2 overcorrections which is a much more serious 3 problem. Again, if we're talking about myopia, if 4 we're talking about hyperopia, it's a different 5 set of problems, but also a serious set of 6 problems. 7 So you need to look at what's going on. Any 8 time -- to me, that would be a trigger for both 9 the manufacturer and FDA to say, what's going on 10 here? Why do we have a, an overall retreatment 11 rate that exceeds the treatment rate that we 12 expected and was a part of the clinical trial? Is 13 it due to an excessive number of undercorrections? 14 Why? Is it due to an excessive number of 15 overcorrections, that's alarming. Is it due to a 16 lot of off-label use? That's another set of 17 issues. You know, so there are, you -- when you 18 start pulling at that string, there, it raises a 19 lot of concerns. 20 I don't, obviously, I don't have a full set 21 of information, so I can't, I can't offer an 22 opinion as to, you know, what the mix was. But I 23 do know there were overcorrections apparently 24 post-approval, and they were not in the clinical 25 trial. So how were they handled? I don't know. 117 1 I have not seen. 2 Q. (BY MR. HARRIS) Well, let's, let's address that 3 now. Assume with me that Alcon doesn't even keep 4 track of overcorrections and undercorrections by 5 statistic overall in their own market -- 6 MR. BROWN: Objection to the form. 7 Q. (BY MR. HARRIS) -- as Dr. Potvin and Mr. Osborn 8 testified. Assume that's true, they don't even 9 keep statistics of that sort. Is there any 10 reasonable way that Alcon would discover that? 11 MR. BROWN: Objection to the form. 12 Mischaracterizes testimony with respect to 13 undercorrections, overcorrections, and 14 recordkeeping. 15 THE WITNESS: If it turns out that Alcon does 16 not keep those records, that would be my view a 17 serious problem because it goes to the heart of 18 knowing what your device is doing on the market. 19 Seems to me that everyone is, knows that 20 overcorrections in particular are a serious 21 problem, very difficult to correct. And depending 22 on whether you're dealing with hyperopia or 23 myopia, and especially if you're dealing with 24 trying to modify astigmatism, if you, if you've 25 got these unplanned outcomes, you should know what 118 1 the outcomes are so that you can fix whatever 2 needs to be fixed. If it is a nomogram issue, 3 then you need to fix the nomogram issue. If it's 4 a problem with the algorithm of the device, then 5 you need to fix the algorithm. 6 And I, of course from my vantage point 7 outside both FDA and the company, I can't tell. I 8 have not enough information to know what the 9 problem is, but there's a, again there's a kind of 10 a footprint of the performance that suggests that 11 people weren't keeping track of key items that 12 would indicate there's a problem with the product. 13 Q. (BY MR. HARRIS) So if you don't keep track of 14 those things in a statistical sort of way, you 15 don't even know to look for those problems, do 16 you, sir? 17 MR. BROWN: Objection to the form. Calls for 18 speculation. 19 THE WITNESS: That is correct. 20 Q. (BY MR. HARRIS) Now, you mention astigmatism. 21 Suppose we have, assume with me that we have 22 doctors reporting astigmatism present after the 23 operation that was not present before. In other 24 words, this person didn't start with astigmatism, 25 but they have it after the operation. Is that a 119 1 reportable event in your view? 2 MR. BROWN: Objection to the form. 3 THE WITNESS: Induced astigmatism above the 4 level of approval, I don't remember offhand what 5 that was, is reportable. I mean, it's an adverse 6 event. 7 And again, any, there was a great deal of 8 discussion of the ophthalmic devices panel about, 9 and it was always an issue. If you have an eye 10 that doesn't have astigmatism, inducing 11 astigmatism can be -- it's not something you want. 12 You don't want to trade off correcting myopia but 13 inducing an astigmatism. And it's hard to 14 correct. It's hard to fix. So you want to keep 15 those rates of induced astigmatism extremely low. 16 Now, the, there was a, as I understand it, 17 there was an understanding by FDA and the panel 18 that there was a certain amount of what's the 19 right word? A certain amount of low level 20 astigmatism that for some reason that no one 21 seemed to understand was induced by this machine. 22 It was a very low level, and the agency wasn't, 23 expressed some amount of concern, but since it was 24 at a very low level and very predictable, there 25 was no -- it didn't seem to be problematic from 120 1 the standpoint of approval. But if that rate went 2 up afterwards, then that, that is a, of concern. 3 And also when you're talking about an astigmatism, 4 it has to, complicated factor has to do with the 5 axis of that astigmatism. If you are inducing a 6 particular axis change in the astigmatism, it can 7 be more of a problem for the vision of the patient 8 than otherwise. So it is something to be paid 9 close attention to. 10 Q. (BY MR. HARRIS) And this induced, in your 11 opinion, is induced astigmatism something that 12 Alcon was supposed to keep track of? 13 MR. BROWN: Objection to the form. 14 THE WITNESS: Yes. 15 Q. (BY MR. HARRIS) And assume with me that Alcon did 16 not even keep statistics of astigmatism that 17 occurred on its machine. Would that be a problem 18 from a FDA standpoint? 19 MR. BROWN: Objection to the form. 20 THE WITNESS: If they did not keep track of 21 it, that would be, I think that would be a 22 problem. 23 Q. (BY MR. HARRIS) And if it was so -- assume with 24 me that doctors around the country including 25 Dr. Sheri Rowen, including Dr. Chotiner who was on 121 1 the phone call made reports of induced astigmatism 2 to Alcon and Alcon didn't even put those reports 3 together in any kind of statistical or 4 intelligible form, would that be a problem from an 5 FDA standpoint? 6 MR. BROWN: Objection to the form. 7 THE WITNESS: It would. Those, those were, 8 even though it was in a conference call, those 9 were complaints in my opinion to Alcon, and I 10 don't know if any follow-up occurred from Alcon, 11 but if they were not followed up or not tracked, 12 then that's a problem. 13 Q. I represent to you that Executive Vice president 14 Stephens who was helping to conduct that call 15 testified in a deposition that he did follow up on 16 several of the, several of the doctors but did not 17 follow up on Dr. Chotiner and another doctor who 18 had a high retreatment rate and said that, said he 19 wouldn't follow up unless the doctor wanted him 20 to. 21 MR. BROWN: Objection to the form. 22 Mischaracterization. 23 Q. (BY MR. HARRIS) Is that the, is that the FDA 24 criteria that you don't follow up unless a doctor 25 wants you to? 122 1 MR. BROWN: Objection to the form. 2 Mischaracterization. 3 THE WITNESS: No. I would -- you're supposed 4 to follow -- there are procedures for following up 5 on complaints. And there needs to be a 6 follow-up -- that was a complaint when it came in 7 as a conference call, and there should have been a 8 follow-up. There didn't have to be a second 9 letter or second complaint for those individuals 10 to trigger an official investigation or procedure. 11 Q. (BY MR. HARRIS) So once, once those doctors on 12 the phone call that's conveyed their complaints to 13 the president of the company, Chet Osborn, the 14 head of technical services, and the various other 15 people in the phone call, they were obliged in 16 your view to follow up on those complaints? 17 MR. BROWN: Objection to the form. 18 THE WITNESS: Correct. You know, one of the 19 interesting mistakes I think that unfortunately a 20 number of companies make is that complaints could 21 come in in a variety of forms and a variety of 22 places in a company. And the company needs to, 23 you know, if they come in at a high level, that 24 high level needs to pump those complaints down the 25 its complaint handling folks. 123 1 I was a compliance officer for a large 2 company that they had field staff that were 3 getting totally different kind of product. They 4 were getting reports from doctors in the field. 5 You know, we had a little problem with this or we 6 had a little problem with that. And they were 7 noting them and they were giving advice back to 8 the docs, and they were putting them over in a 9 corner of their offices in the field. And it was 10 a big problem for that company. It cost that 11 manufacturer a lot of money. So it's a big 12 problem. And it's a challenging problem for a 13 company that is, that, to keep, manage complaints 14 that come in in a variety of places. But that's 15 their, that's the task they have to do. And so it 16 would be a problem. It would be a problem. 17 Q. (BY MR. HARRIS) And speaking of reporting, we were 18 talking earlier about unscheduled maintenance. 19 And you were asked if you're aware of the 20 maintenance, if you had looked at the maintenance 21 records of Dr. Rowen or indeed any of the other 22 EBW lasers? Do you recall that? 23 A. Yes. 24 Q. And assume with me that it turns out that those 25 maintenance records simply list the maintenance 124 1 one after another in order and don't say one way 2 or another if they're unscheduled maintenance and 3 don't attempt any breakdown and don't then compile 4 the unscheduled maintenance together in any kind 5 of statistical way? Is that what you had in mind 6 by reporting unscheduled maintenance? 7 MR. BROWN: Objection to the form. 8 THE WITNESS: Well, I think it quite clear 9 what FDA means by unscheduled maintenance. You 10 know, there is a regular routine maintenance 11 that's made on any product, and you have to have a 12 schedule of that. When they're called in, because 13 there's a translator problem or whatever problem 14 is, that's unscheduled. I mean, it wasn't part of 15 the ordinary routine -- in fact, one of the few 16 people that's outside the agency -- I have much 17 information from my years there. 18 You know, one of the big brouhahas we had 19 early on in the early lasers was that to make it 20 clear to the early Visx and early Summit 21 manufacturers that they had to define explicitly 22 what their maintenance schedule was going to be 23 because frankly, in the early days, we didn't 24 understand the -- these were technically very 25 novel devices for us. 125 1 Q. (BY MR. HARRIS) Sure. 2 A. And we were very concerned that the companies 3 would not be, have the people available to deal 4 with the challenges of this excimer gas mixture. 5 And at that time they had much more primitive ways 6 of dealing with it. So we had built in a 7 requirement that in their operations manual, that 8 they define a maintenance schedule. 9 I assume that's still the case. I know we 10 did that. And then, that so anything else is 11 unscheduled, and they had to keep track of the 12 unscheduled because that's what's telling you that 13 there's a problem. 14 Q. When you say keep track of it, does that mean 15 designate them as unscheduled maintenance and put 16 them in some category or does it mean just throw 17 them in a box and forget them? 18 A. No, it means keeping -- 19 MR. BROWN: Objection to the form. 20 THE WITNESS: Keeping track of events that 21 are unscheduled maintenances and service calls. 22 Q. (BY MR. HARRIS) And in your opinion, is there, is 23 there some kind of implication of that, that 24 they're supposed to keep statistical track of that 25 to look for similarities, to look for things that 126 1 are the same to see if there's a report in 2 Seattle, Washington that matches Towson, Maryland, 3 for example, or can they simply keep it and forget 4 it? 5 MR. BROWN: Objection to the form. 6 THE WITNESS: No, the whole quality systems 7 regulations would require them to keep track of, 8 of those -- the whole point of the quality system 9 regulations is to establish a management system 10 that keeps track of events, whether they're 11 clinical events, or in this case device events, so 12 that they can see if there's some degradation of 13 the product over time or is there some unusual 14 piece of the equipment that they hadn't 15 anticipated a problem, like in the recalls that 16 they discovered. 17 Q. (BY MR. HARRIS) Right. 18 A. I mean, they found out that, I don't know how they 19 found out those, but one way to find out about 20 those kind of things is, you know, you're doing a 21 lot of service calls on this particular subsystem, 22 and you know, wow, that happened here and there, 23 and you know it shouldn't be happening, so you 24 know there's a problem. Otherwise how do you know 25 there's a problem? 127 1 Q. So if I hear you correctly, keeping track of 2 unscheduled maintenance has an implied duty to 3 also try to make some sense of it? Try to put it 4 together in some intelligible form? 5 MR. BROWN: Objection to the form. 6 THE WITNESS: Yes, indeed. I mean, you know, 7 it's not there just to keep the paper industry 8 happy or the electronics industry. I mean, it's 9 there to, as a protective measure, you know, to 10 catch, to catch problems with the device before 11 they injure somebody. Basically. I mean that's 12 the whole point of it. 13 That's why in the first two years they 14 require the company to specifically report 15 annually those unexpected, those unscheduled 16 maintenance reports. The assumption being that 17 there will be sort of a shake-out for the 18 manufacturer of that device so that by the end of 19 those two years, you know, they wouldn't have to 20 report them annually, but they would be keeping 21 track of them. It's an understanding that, in the 22 general, the general quality system regulations 23 that they manage those problems. 24 Q. Were you present when Chet Osborn, the head of 25 technical services, testified under oath that he 128 1 didn't even know what unscheduled maintenance was? 2 Were you present when he said that? 3 MR. BROWN: Objection to the form. 4 THE WITNESS: I was. 5 Q. (BY MR. HARRIS) And did it surprise you that the 6 head of technical services that supervises all the 7 people that do all the maintenance all over the 8 country didn't even know what unscheduled 9 maintenance was? 10 A. I was quite stunned actually. 11 Q. Did that suggest to you that since they didn't 12 know what it is, they were probably not keeping 13 track of it? 14 MR. BROWN: Objection to the form with 15 respect to the definition of -- 16 THE WITNESS: I assume the head of service 17 would know what unscheduled maintenance are and 18 know what they're keeping track of. I don't know 19 what else to say. Yeah, I, I was nonplussed. 20 Q. (BY MR. HARRIS) Assume with me that Chet Osborn 21 is right, that they don't know what unscheduled 22 maintenance is and the company is not, in fact, 23 creeping track of unscheduled maintenance in any 24 meaningful statistical way. Assume that with me. 25 Does that indicate that this machine is not being 129 1 tracked properly from the FDA standpoint? 2 MR. BROWN: Objection to the form. 3 THE WITNESS: Yes. I mean, it's a basic 4 fundamental of having a good quality product. You 5 know, you have your -- every company, they have a 6 quality system manual that lists out the standard 7 operating procedures, and there should be 8 someplace in their quality system manual when you 9 dig down into it, there should be some sort of 10 standard operating procedure that deals with how 11 to handle unscheduled maintenance. And which 12 there should be somebody that's keeping track of 13 that, somebody that's making sure that if there's 14 a lot of unusual wear and tear on a particular 15 component, unusual events, that somebody's 16 notified. 17 In fact, there should be, my experience, 18 since I was at the agency, I've had a lot of 19 compliance experience which has been a 20 fascinating, and you know, they have, companies 21 have quarterly or more frequent, usually often 22 more frequent meetings of management with the 23 various staff to determine, you know, how are 24 things going? You know, do we have any problems 25 with the product? And so that management can't 130 1 simply say, well, service didn't tell us that 2 there was a problem. So we didn't report it or we 3 didn't keep track of it. So yeah, it's a problem. 4 Q. (BY MR. HARRIS) And using your experience, your 5 long experience with the FDA and your knowledge of 6 the regulations, does the -- and operating under 7 that same assumption I had in the previous 8 question that Alcon didn't even have any 9 meaningful, statistical way of keeping track of 10 unscheduled maintenance, does that indicate to you 11 that Alcon had problems it doesn't even know it 12 has because it has no real way of finding out 13 about those problems? 14 MR. BROWN: Objection to the form. 15 THE WITNESS: If those facts are correct, I'm 16 saddened to say that's correct. I mean, how would 17 you know that you have a problem with your product 18 that's on the market unless you're tracking a, key 19 features of the product, its performance, both 20 mechanically, electrically, and you know that by 21 getting feedback from your service people. You 22 know that by getting feedback from your 23 clinicians. You know, there are many, you need to 24 track that information. There's no ifs, ands, and 25 buts about that. 131 1 Q. (BY MR. HARRIS) And by tracking information, do 2 you mean to determine if there are trends of 3 common problems in a machine? Do you mean that? 4 A. Yes, I do, because it tells you a lot. If you're 5 getting individual occurrences of quite different 6 problems here and there, that's one thing, but if 7 you are, for example, as it appears in what 8 material I've read, there were strength problems 9 with translators. 10 Q. Yes. 11 A. Then that's kind of notable, you know, so maybe 12 there is a need for recall on the machine because 13 of some sort of problem with quality in making 14 these translators. I don't know the technical 15 details, but it's a clue that you've got a 16 problem. It's sort of a quality control 17 procedure. And my work with other companies since 18 I've been at the FDA, I mean, they have quality 19 inspectors in the companies that, whose job is 20 within the company to make sure that it meets 21 specifications and that it, it stays inspected 22 after it's out there, so I agree. 23 Q. (BY MR. HARRIS) Is the purpose of keeping track 24 of the unscheduled maintenance to look for and 25 establish trends such as you've been talking 132 1 about? 2 MR. BROWN: Objection to the form. 3 THE WITNESS: I'm sorry. Say that again? 4 Q. (BY MR. HARRIS) Sure. Is the purpose of keeping 5 track of unscheduled maintenance, one of the 6 purposes anyway of keeping track of unscheduled 7 maintenance, in order to define trends, such as 8 you've been talking about, trends of a problem 9 that seems to be there or trends to be there? 10 MR. BROWN: Objection to the form. 11 THE WITNESS: Sure. Absolutely. Sorry. Of 12 course. That's the only way you would know that 13 there are any commonalities amongst the problems 14 that are occurring, if there are. And so if you 15 don't track them, you don't know about them. But 16 that's not a good practice. You need to record 17 them, track them so you can find out if there are 18 any trends. And if there are no trends, that's 19 fine. If there are, then you can figure out how 20 to solve that problem that you've identified. You 21 can't solve a problem you haven't identified, you 22 know, so you need the input information in order 23 to identify the problem. 24 Q. (BY MR. HARRIS) I heard your phrase, "if you 25 don't track them, you don't know about them." Did 133 1 I hear your phrase correctly? 2 A. That's correct. 3 Q. Does that mean that problems can effectively hide 4 in, amongst the various clinics throughout the 5 United States without the company being aware of 6 them because they're not tracking them? 7 MR. BROWN: Objection to the form. 8 THE WITNESS: Yes, of course. I mean, but 9 it's the company's responsibility to know what 10 their machines are doing. And so it is not good 11 practice not to know. It's not good practice at 12 all. You need to know what your machines are 13 doing. 14 I had a doc asked me who, in the early days 15 of developing these machines, there were a couple 16 of docs who wanted to manufacture, who wanted to 17 be the owner of a PMA as, Emory University, for 18 example, one of the, they had their own Summit 19 and, they made changes with their own Summit, was 20 a fascinating period, and they wanted to be a PMA 21 owner of that particular, very unusual Summit 22 laser. 23 And so I explained to them what their 24 responsibilities were, that they were married to 25 the FDA once they got the, owner and holder of 134 1 that PMA, they were married to the FDA. They had 2 reporting requirements. They had reporting 3 requirements. I explained to them in great 4 detail, here is what you're going to have to do 5 annually. You're going to have to have staff that 6 keeps track of these. They decided hmm, that's 7 not a good idea. We're a clinic. We don't want 8 to be having manufacturers' responsibilities. 9 So it a big deal. It is not for the faint of 10 heart actually. I don't minimize it because it's, 11 it's expensive, and it's, but it's the only way to 12 know whether the machine is, in fact, working as 13 intended and not creating problems. 14 Q. (BY MR. HARRIS) It sounds as though you're 15 describing a type of covenant between the company 16 and the FDA in order to protect the public. Is 17 that about the size of it? 18 MR. BROWN: Objection to the form. Ludicrous 19 question. 20 THE WITNESS: That's a good way of phrasing 21 it actually. It's an agreement. 22 Q. (BY MR. HARRIS) Now, you also described a process 23 earlier where the, in essence, the complaint from 24 the doctor doesn't in and of itself establish 25 complaint to the FDA; is that correct? 135 1 MR. BROWN: Objection to the form. 2 THE WITNESS: That's correct. 3 Q. (BY MR. HARRIS) And if I understand you 4 correctly, the way the process works is if a 5 doctor makes a complaint to the company, the 6 company has to evaluate that complaint and 7 determine if it's appropriate to report to the 8 FDA; is that the way the process works? 9 A. Yeah, that's correct. 10 Q. And if the, if the company is not performing the 11 statistical analysis and looking at the trends and 12 keeping a record of whether it be retreatment 13 rates or unscheduled maintenance, doesn't that 14 significantly impair their ability to determine 15 whether they have a problem or not? 16 MR. BROWN: Objection to the form. 17 Q. (BY MR. HARRIS) To file a complaint? 18 A. You are absolutely correct. I mean again, how can 19 you fix a problem if you don't know the problem 20 exists. And you don't know the problem exists 21 unless you record data of some sort regarding 22 unscheduled visits, scheduled visits, what you 23 found on scheduled visits even, because sometimes 24 you find on scheduled visits things that were 25 unexpected. 136 1 So the devil is in the details, and all of 2 those are the responsibility of the manufacturer 3 to keep track of. Adverse events. Even if 4 they're not classified as adverse events, if a doc 5 complains about something, I know it was an 6 earlier issue having to do with decentration. 7 Decentration can be due to a variety of things 8 including the doctor not knowing what they're 9 doing, not following instructions properly, and I 10 absolutely agree that that's true. 11 But the fact that there is a decentration 12 needs to be followed up. It needs to go into the 13 complaint handling process and needs to be 14 standard operating procedure for handling -- I 15 haven't seen those, so I don't know. 16 Q. Yes. 17 A. You know, maybe they're not adequate. I really 18 can't speak to that. But certainly there needs, 19 that's the way it works. That's the way it's 20 supposed to work. It's a self-monitoring system, 21 the agency and A20 basically gives the 22 manufacturers responsibility and accountability 23 for keeping track of their product. 24 Q. (BY MR. HARRIS) And if you had a decentration, 25 wouldn't one thing you'd want to look at is 137 1 whether there had been unscheduled maintenance in 2 the recent past on that particular machine? Would 3 that be one thing you'd want the look at? 4 MR. BROWN: Objection to the form. 5 THE WITNESS: Sure. 6 Q. (BY MR. HARRIS) And might you want to also 7 compare that decentration with other decentration 8 to see if there had been an unscheduled 9 maintenance of a similar sort on that machine, 10 also? Wouldn't that be a logical thing to look 11 at? 12 MR. BROWN: Objection to form. 13 THE WITNESS: Of course, you'd want to see if 14 there's any commonalities amongst the machines. 15 Q. (BY MR. BROWN) But if you don't even keep track 16 of those kind of things statistically, then you're 17 significantly impaired in looking into that, 18 aren't you? 19 MR. BROWN: Objection to the form. 20 THE WITNESS: That is correct. 21 Q. (BY MR. HARRIS) Now, I've discussed with you up 22 to now an instance where I suppose it might be 23 said the company might be negligent in not 24 keeping, not keeping track of statistics. 25 MR. BROWN: I'm sorry, Doug. I didn't hear 138 1 the word. 2 Q. (BY MR. HARRIS) Negligent. Let me propose 3 another scenario. Suppose with me that the 4 company's in acting is in bad faith. In other 5 words, they see the problem. They know it's a 6 problem, but they don't report it to the FDA. In 7 other words, they know they got a machine problem. 8 Is there any practical way for that to get picked 9 up until they're caught? 10 MR. BROWN: Objection to the form. 11 THE WITNESS: Not really. The only way that 12 gets picked up -- tell you about another case, and 13 that happened sometimes when there's a whistle 14 blower within the company. 15 Q. (BY MR. HARRIS) Right. 16 A. And sets them up for that problem. And then 17 things start to unwind, and that's a serious 18 problem. Lying to the government is not a good 19 idea. 20 Q. I've heard that. 21 MR. BROWN: Are you suggesting that Alcon is 22 lying to the government and that the whistle 23 blower that you're talking about, that's not an 24 Alcon matter, correct? 25 THE WITNESS: No, no, no. 139 1 MR. BROWN: Let's just make sure the record's 2 clear, when Mr. Harris laughs about things like 3 that, that under oath you're not suggesting that 4 either Alcon has lied to the government -- 5 correct? 6 MR. HARRIS: You're interrupting my 7 cross-examination. 8 THE WITNESS: I absolutely agree. I was -- 9 in fact, I said before -- 10 MR. HARRIS: You can stop right now. He's 11 asking a question out of order. He can ask that 12 later if he wants to. I'm asking questions. 13 THE WITNESS: Did you want me to continue? 14 MR. HARRIS: No. Don't answer a question 15 that's posed across the table until it's his turn. 16 All right. 17 Q. (BY MR. HARRIS) Now let's go back to Dr. Potvin 18 for just a minute. Did you hear Rick Potvin, 19 their, the Alcon statistician, say that he had 20 statistically analyzed the retreatment rates of a 21 couple of doctors, Dr. Will, Dr. Sloane 22 specifically? You remember him saying that? 23 A. Uh-huh. Correct. 24 Q. And do you remember the very first thing he did 25 was he went and got the retreatment rates of those 140 1 doctors, the billing retreatment rates from the 2 billing records from the Fort Worth office? Do 3 you remember him saying he did that? 4 MR. BROWN: Objection to the form. 5 Mischaracterization. 6 THE WITNESS: That's correct. 7 Q. (BY MR. HARRIS) And do you further remember that 8 he said that in order to get accurate retreatment 9 rates, you would then need to back out the 10 retreatments that occurred on the Alcon machine 11 where the original treatment had occurred on a 12 different brand of machine? Do you recall him 13 saying that? 14 MR. BROWN: Objection to the form. 15 THE WITNESS: Correct. I do. 16 Q. (BY MR. HARRIS) And do you also recall that 17 Dr. Potvin testified that those retreatments that 18 are done on an Alcon machine that were the, where 19 the original treatment was done on a different 20 branded machine are coded so that he could easily 21 pull them out and cull them out of the retreatment 22 levels. Do you recall him saying that? 23 MR. BROWN: Objection to the form. 24 Mischaracterization. 25 THE WITNESS: That is correct. 141 1 Q. (BY MR. HARRIS) And do you recall Dr. Potvin 2 saying that he couldn't be quite sure as to how 3 many retreatments there were of that variety that 4 were done on a different machine where the 5 retreatment was done on the Alcon machine where 6 the original treatment was done an another, but 7 that in any event, it was certainly something less 8 than 20 percent of the totally retreatments. Do 9 you recall that testimony? 10 MR. BROWN: Objection to the form. 11 Mischaracterization and just a continuing 12 objection to the entire line of questioning as 13 improper and leading. 14 THE WITNESS: I recall that, but I'm not sure 15 I recall that it was Dr. Potvin who said about the 16 20 percent. I thought it was someone else. But 17 the -- I do recall that someone. It was little 18 while ago and I haven't -- 19 Q. (BY MR. HARRIS) Right. Well, in any event, even 20 if we take away 20 percent of the retreatments, do 21 we still have significant retreatment problems on 22 a number of these machines? 23 MR. BROWN: Objection to the form. 24 THE WITNESS: Sure. There were some that, 25 had almost 80 percent retreatment rate which is 142 1 astonishing to me. So, you know, you don't start 2 to understand what's going on there. That's kind 3 of -- 4 Q. (BY MR. HARRIS) This indicate a serious problem 5 to you given your experience and training? 6 MR. BROWN: Objection to the form. 7 THE WITNESS: It's -- again, it's an 8 indicator that either there's one incredible 9 amount of off-label use or there is something, or 10 there's a lot of overtreatment or there's a lot 11 of -- I mean, a lot of overcorrections or a lot of 12 undercorrections. Something is going on. 13 I mean, that's like sending up a flare 14 saying, there's a problem here. I mean, either 15 there's a serious problem with the docs' use of 16 the instructions or it's a serious off-label issue 17 or something. Something warrants some follow-up. 18 And the 80 percent, 50 percent, 40, 30. 19 These are all very high numbers. So you need to 20 look, you need to look behind those overall 21 numbers to look at what I think is referred to as 22 the actual retreatment rate of the patients, but 23 these overall numbers tell you, it's like a big 24 sign saying, come look at me. I've got a problem. 25 Q. (BY MR. HARRIS) And basing your, based on your -- 143 1 let me rephrase that. Did you hear the testimony 2 of Chet Osborn that he didn't know of any norm for 3 a retreatment rate, that there was no particular 4 norm? Did you hear that testimony? 5 MR. BROWN: Objection to the form. 6 THE WITNESS: Yes, I did. 7 Q. (BY MR. HARRIS) And did you hear his testimony 8 that he didn't know of any retreatment level that 9 was too high? 10 MR. BROWN: Objection to the form. 11 THE WITNESS: Yes, I did. 12 Q. (BY MR. HARRIS) And did you also hear, did you 13 also have occasion to hear me question him about 14 his memo which he said a 20 percent retreatment 15 rate was too high, specifically in reference to a 16 machine in Albuquerque Dr. Alfred Bernitsky said 17 they replaced. Did you hear that testimony? 18 MR. BROWN: Objection to the form. 19 THE WITNESS: Yes, I did. 20 Q. (BY MR. HARRIS) Was there anything in the 21 testimony that you heard from their head of 22 technical services, Chet Osborn, that led you to 23 believe that anybody at technical services were 24 paying any attention whatsoever to the retreatment 25 rates you've been describing? Anything? 144 1 MR. BROWN: Objection to the form. 2 THE WITNESS: Well, I don't know whether they 3 weren't paying attention to it or whether they 4 were ignoring the retreatment rates. I was 5 puzzled by this sort of flexible notion of 6 retreatment rate being defined by the site, so 7 that a 10 percent could be okay or 20 percent 8 could be okay or 40 percent could be okay. 9 It just seemed very strange to me, given what 10 I know about how we got, how we arrived, we being 11 the FDA, how FDA arrived at what our acceptable 12 treatment rates, the notion that somehow these are 13 so flexible that there's no real, there's no real 14 limit to retreatment rates. I mean, I just, 15 puzzling to me. I don't understand. 16 Q. (BY MR. HARRIS) Is there any basis for that 17 notion in FDA rules that you can have different 18 retreatment rates for the same type of operation 19 in different parts of the United States? 20 MR. BROWN: Objection to the form. 21 THE WITNESS: I've never heard of such a 22 thing frankly. 23 Q. (BY MR. HARRIS) Was the statement you heard Chet 24 Osborn make as to you had different acceptable 25 retreatment rates in different parts of the 145 1 country at all in keeping with what the FDA 2 allows? 3 MR. BROWN: Objection to the form. 4 Mischaracterization of testimony. 5 THE WITNESS: No. 6 Q. (BY MR. HARRIS) Now you have several times 7 mentioned Emory University and their program down 8 there. I take it they were one of the, one of the 9 eye centers that were doing the initial tests for 10 this machine, the Autonomous? 11 A. Actually I don't know about the Autonomous, no, 12 they doing a -- they did a -- 13 MR. BROWN: Objection to the form. 14 THE WITNESS: I can't remember the guy's name 15 now. It's been -- Stulting was one of the group. 16 I can't remember the other fellow's name. Bill 17 Stulting was one. They had one of the very early 18 Summit lasers, one of the early Summit lasers. 19 Q. (BY MR. HARRIS) That was predecessor to this one? 20 A. It was a predecessor. It was not an Alcon. I 21 don't know if they ever had an Alcon in the 22 clinical trials. I'm not really sure. But they 23 did have a -- my example there had to do with 24 their, their efforts -- it was really to try to 25 explain the importance of trying to get as close 146 1 as possible on the first treatment to what you 2 intended. And their whole effort sort of led the 3 field to defining that algorithm and that nomogram 4 as tightly as possible, and that's what my example 5 was. It didn't have anything to do directly with 6 Alcon or Autonomous. 7 Q. Now what's the difference if you get as close as 8 possible with the first treatment? Why not do one 9 or two more? What's the difference? 10 MR. BROWN: Objection to the form. 11 THE WITNESS: Well, if you have to lift the 12 flap a second time. You have to set up the 13 patient a second time. You have errors when 14 you're doing the surgery the second time. There 15 are all kinds of issues that you have, that the 16 doc has to send to the patient the second time. 17 If there are inaccuracies the first time, they 18 have to be somehow dealt with in the second 19 go-round. So it is a -- it is not a, you know, 20 it's not something you really want to do. If you 21 plan to do a retreatment and you have a logic for 22 why you're doing the retreatment because -- say, 23 for example, you have a very high myopia, just 24 talk about the simplest ones. 25 Q. .Sure? 147 1 A. Say it's a 15 myop, you know, and you're not going 2 to, you can't, in one, if you tried to do that 3 operation with one, with one surgery, you're going 4 to take off too much tissue, so you may plan to do 5 seven or eight that first surgery. 6 Q. Yes? 7 A. And do seven or eight on that second time. 8 Because, but this patient has got terrible vision, 9 and you know this is a high risk patient, and so 10 therefore you plan for a retreatment. That's a 11 different story. 12 Q. In your experience, is that a rarity? 13 A. I don't know how rare it is actually. I mean, I 14 really don't know. But I know that it's, those 15 patients are patients that have to be treated with 16 some -- that's why, in fact, you have the practice 17 of medicine rule. That's why, in fact, we did not 18 lock out, we did not lock out Autonomous, Alcon 19 from allowing doctors in the practice of medicine 20 rule to treat patients like that because we 21 wanted, we wanted doctors to have the freedom to 22 use this piece of surgical equipment to treat 23 patients that don't fit into the patient 24 population that was initially studied but under 25 the doctor's decision could be treated under this 148 1 authority to do that. 2 So I absolutely agree that they have, they 3 need that flexibility. But there is a price from 4 both, for the doctor and for the company when that 5 so-called off-label user you're, practice of 6 medicine occurs because we don't know the safety 7 or effectiveness outcomes of those procedures, so 8 if they're occurring a lot, both the doctor and 9 the company have a responsibility to keep track of 10 those and to report them in an appropriate time 11 frames or keep record of them. 12 Q. Is that one of the reasons a certain amount of 13 retreatments are allowed? That's not a problem? 14 MR. BROWN: Objection to the form. 15 THE WITNESS: Correct. I mean, you know, 16 there needs to be flexibility for the surgeon and 17 for the company to -- you know, the early days of 18 the approval of the devices there was an effort 19 made to lock out procedures. In fact, we did in 20 some of the early devices because we knew very 21 little about them. We said the early Visx, the 22 early Summit machines were approved. I don't 23 remember the exact numbers, but they were approved 24 to treat only up to 4 diopters of astigmatism. I 25 mean, 4 diopters of myopia. 149 1 And we told the companies, you cannot, you 2 have to put a lock on the machine to prevent the 3 doctors from treating above that because we don't 4 know the safety and effectiveness out because we 5 were very nervous. We wanted to preclude practice 6 of medicine by locking, physically locking out 7 that. And that created a lot of uproar from the 8 physicians. 9 Q. (BY MR. HARRIS) But later on you loosened it up? 10 A. But later on, as we got more experienced in what 11 data came in about those higher treatments, you 12 know, and I must say I led the way, and I'm proud 13 of it. I lead the way to allowing that practice 14 of medicine, so I think it's a very important 15 feature. Certainly, a company shouldn't be 16 criticized, doctors using it for a procedure that 17 it wasn't approved for. 18 Q. And in a like manner, a certain amount of 19 retreatments below what the FDA allows certainly 20 doesn't indicate any kind of problem with the 21 doctor or the machine, does it? 22 A. No. 23 Q. But if the retreatment rates go up to levels 24 you're talking about, 40, 50, 60, 80 percent, that 25 does indicate a problem with the machine or the 150 1 doctor, doesn't it? 2 MR. BROWN: Objection to the form. Asked and 3 answered 17 times. 4 THE WITNESS: Simply said, yes. I can't see 5 how those can be arrived at in any sensible 6 fashion without indicating some problem, some sort 7 of a problem. 8 Q. (BY MR. HARRIS) And if, and if those kind of 9 rates are occurring all over the country with all 10 different serial number machines and all different 11 doctors, that tends to lead more toward the 12 conclusion it's the machine rather than the 13 doctor, doesn't it? 14 MR. BROWN: Objection to the form. Calls for 15 speculation. Lack of foundation. 16 THE WITNESS: I would make -- I mean, I would 17 tell you, I have worked for companies, and I've 18 worked for the FDA. And I would take the worst 19 case approach to it, and I'd say, look, look to 20 thyself. Is there a problem here? You know, we, 21 are we inadvertently creating a problem here? And 22 disprove that, rather than assuming there's no 23 problem and not investigating it. 24 So I would, that sort of the basic approach 25 I've taken. I would sort of put on my FDA hat and 151 1 my compliance hat that I've done for other 2 companies and say, look, you know, don't assume 3 that everything is rosy. I mean, assume that 4 it's, it's a problem and then disprove that it's a 5 problem. And that's fine if you disprove it. 6 Q. (BY MR. HARRIS) And what about the reputation and 7 the experience you've had with a given clinic? Is 8 that one thing you'd take into account if you're 9 trying to decide if it's a machine or a doctor 10 problem? 11 MR. BROWN: Objection to the form. 12 THE WITNESS: Oh, sure. You know, it may 13 be -- there are all sorts of surgeons around. 14 Q. (BY MR. HARRIS) Sure. 15 A. And it's quite possible that surgeons don't follow 16 instructions. I mean, if they're like me with 17 regard to a new gidget at home, I plug it in 18 first, and then I read the instructions. So 19 hopefully, the surgeons don't do that. But I 20 mean, some are better than others unfortunately. 21 So I am sure there are some that do not, are not 22 as meticulous in following instructions or, you 23 know, there's a lot that goes in -- there's a lot 24 of mistakes that can happen when they're taking a 25 refraction of the patient or entering it into the 152 1 machine. They're off a digit. There's a lot of 2 ways to screw up. So yes, this is a big deal for 3 the surgeon. 4 Q. And how about Emory University which you've 5 mentioned several times. Is that somebody in your 6 experience that you have confidence in? 7 MR. BROWN: Objection to the form. 8 THE WITNESS: Oh, they're one of the premiere 9 laser correction centers. They're early pioneers 10 in this business, and they have many -- not just 11 Stulting, but they have many fantastic surgeons 12 there, lots and lots of experience. 13 Q. (BY MR. HARRIS) And would the fact that they had a 14 23.3 percent retreatment rate in 2001 be a problem 15 in your view, in your experience? 16 MR. BROWN: Objection. Objection to the 17 form. 18 THE WITNESS: It indicates a problem until 19 otherwise demonstrated. 20 Q. (BY MR. HARRIS) And would the fact that they had a 21 39.6 percent retreatment rate in 2002 likewise 22 indicate a problem? 23 MR. BROWN: Objection to the form. 24 THE WITNESS: That does to me. 25 Q. (BY MR. HARRIS) Would this be something in your 153 1 view that would compel looking into by the 2 company? 3 MR. BROWN: Objection to the form. 4 THE WITNESS: Yes. 5 Q. (BY MR. HARRIS) And do you find it to be 6 consistent with Chet Osborn's comment that a 7 retreatment rate of 20 percent really is not very 8 good? Is that consistent with what you say here? 9 MR. BROWN: Objection to the form. 10 THE WITNESS: No, it isn't. No, it isn't. 11 Q. (BY MR. HARRIS) All right. Now, we've talked 12 about an adverse event as something that might 13 cause death or serious injury. I guess so far as 14 we know, none of these machines ever caused a 15 death, has it, or has it? 16 A. No, unless it fell on them, I can't imagine it 17 would. 18 Q. All right. So what we're really talking about 19 here is what's, what's a serious injury then? 20 MR. BROWN: Objection to the form in that 21 it's not tied to anything, and it's confusing the 22 difference between adverse events and MDR 23 reporting. 24 Q. (BY MR. HARRIS) Now, in your mind, would adverse 25 event be the significant loss of sight caused by 154 1 the machine undercorrecting or over-correcting? 2 Would that be a significant medical event? 3 MR. BROWN: Objection to the form. 4 THE WITNESS: An adverse event -- again, an 5 adverse event is either one of those items that is 6 listed as adverse events that are expected by the 7 device or it's an adverse event or it's an event 8 that occurs to the patient that exceeds the 9 expected rate that's listed. 10 Q. (BY MR. HARRIS) Right. 11 A. And then there are various reporting requirements 12 depending on whether or not there was a serious 13 injury or whether it was likely if not corrected 14 to produce a serious injury. Those are the ones 15 that are reported, MDR reported in certain time 16 frames. So you can, you know, but essentially, 17 you know, these, you know, we know what the safety 18 profile of these devices. They're listed in the 19 labeling. 20 Q. Sure. 21 A. We know what the effectiveness profile of the 22 devices. And the safety -- safety factors go 23 together because you've got an eye that you're 24 trying to correct. And so if it's, if you've got 25 some safety outcome that's pretty good, but the 155 1 effectiveness is way off, then the risk-benefit is 2 not appropriate. So you need to look at both of 3 those. So when, you know, exceeding a retreatment 4 rate of 10.5 or 10.6 in and of itself -- 5 Q. Is an adverse effect? 6 A. Is an adverse event, but it doesn't necessarily 7 mean that that patient had a loss of best 8 corrected vision or it doesn't mean that they had 9 some other clinical sequela, so it wouldn't 10 necessarily be MDR reportable. 11 Q. Yes. 12 A. But when you have a retreatment rate that is 60, 13 70, 80 percent, you start to worry about, you 14 know, were some of those MDR reportable? I don't 15 know because I, I don't have the full picture. It 16 raises a concern in my mind. 17 Q. Right. Sight being one of the five senses, a 18 serious interference with sight would be MDR 19 reportable; would it not? 20 MR. BROWN: Objection to the form. 21 THE WITNESS: Sure. 22 Q. (BY MR. HARRIS) So a person, for example, who did 23 not prior to surgery have an astigmatism and 24 after, after surgery had astigmatism, that might 25 well be reportable; would it not? 156 1 MR. BROWN: Objection to the form. 2 THE WITNESS: It could be if it were a large 3 amount of induced astigmatism, larger than 2 4 diopters and an astigmatism that was in an unusual 5 axis because it's not just the amount of 6 astigmatism that's induced but the axis of it I 7 understand. So yes, not always. Again, the 8 agency approved this machine with a certain, with 9 understanding that it had a certain -- 10 Q. Yes. 11 A. -- amount of induced, low amount of induced 12 astigmatism that was regularly induced. And they 13 didn't know why, but they said, okay, it's small. 14 But, you know, keep it within those limits. So, 15 but when it exceeds those limits, then you start 16 to worry about what's going on. 17 Q. And what about if the astigmatism takes the form 18 of decentered ablation, and it actually causes 19 double vision so that the person is seeing double 20 everywhere they go? Does that describe a 21 reportable event in your mind? 22 MR. BROWN: Objection to the form. 23 THE WITNESS: Yes, those are actually 24 interfering with quality of vision and being able 25 to maneuver around the environment, so there, 157 1 having blurry vision at night especially is a 2 problem. 3 Q. (BY MR. HARRIS) I want this, I want you to assume 4 with me that a scientific journal actually 5 concluded that a decentered ablation was due to a 6 malfunction of the Autonomous machine, the Alcon 7 Autonomous machine, and that that was actually 8 reported in a phone call to the Orlando office of 9 Alcon. In other words, they knew it 10 affirmatively. Does that describe a reportable 11 event? 12 MR. BROWN: Objection to the form. 13 THE WITNESS: It would, you know, knowing the 14 information, that sketchy information, it could 15 be. 16 MR. BROWN: Doug, let me just ask a question. 17 Should we take a break or are you getting close? 18 MR. HARRIS: We can take a break. No 19 problem. 20 (Whereupon a recess was held from 12:12 21 p.m. until 12:17 p.m. that was not 22 reported.) 23 Q. (BY MR. HARRIS) Back on the record? Dr. Waxler, 24 assume with me that representatives of Alcon told 25 Mark McDaniel in the spring of 2003 that Alcon was 158 1 in compliance with all FDA regulations concerning 2 the Autonomous laser. Assume that they told Mark 3 McDaniel that. Is that accurate from your 4 knowledge of FDA regulations? 5 MR. BROWN: Objection to the form. 6 THE WITNESS: Repeat that? 7 MR. HARRIS: I will, I'll be glad to. I want 8 you to assume with me that Alcon 9 representatives -- in other words, people speaking 10 on behalf and for Alcon -- told Mark McDaniel in 11 the spring of 2003, in other words, after the 12 events you've studied here, that Alcon was in 13 compliance with all FDA regulations regarding the 14 Autonomous LadarVision system, is that an accurate 15 statement from your knowledge of FDA regulations? 16 That you've been describing here today? 17 MR. BROWN: Objection to the form. 18 THE WITNESS: No. I think for the reasons 19 I've stated in here, I think that, you know -- 20 obviously, there are judgment calls, but in my 21 opinion, I don't see how that could be. 22 Q. (BY MR. HARRIS) All right. And once the, once 23 the machine is approved by the FDA, can the 24 company just do nothing else? Is it permissible, 25 once they got their, once they got their 159 1 permission, just do nothing else, just sit back 2 and relax? 3 MR. BROWN: Objection. Asked and answered. 4 How much more time are we going to waste on the 5 same question? 6 THE WITNESS: Well, I mean, I think the whole 7 structure of the FDA regulations and the law is, 8 in answer to that, is no. The whole quality 9 system, even during the investigational phase, 10 there are requirement for recordkeeping and so 11 forth. So, and that continues. 12 There's a famous, now famous life cycle map 13 of manufacturer's responsibility throughout the 14 life cycle of the product so they're responsible 15 for it from the conception of the device through 16 its death. So when I say they're married to the 17 mob, married to FDA, they're married to FDA. And 18 so there are many, there are many, many processes 19 along that tie them to this web of 20 responsibilities. 21 Q. (BY MR. HARRIS) Can the number of unscheduled 22 maintenances on a given machine indicate a machine 23 problem? 24 MR. BROWN: Objection to the form. 25 Q. (BY MR. HARRIS) Can they? 160 1 A. It can, of course. 2 Q. And is that one reason it's necessary to keep 3 track of the unscheduled maintenance and keep 4 statistical track of them? 5 MR. BROWN: Objection to the form. Asked and 6 answered. It's the same ground over and over. 7 THE WITNESS: Yes, I agree. 8 Q. (BY MR. HARRIS) Now, we were talking earlier this 9 morning about the FDA recalls, and I understand 10 you had a chance to look at those for the 11 Autonomous LadarVision? 12 A. Correct. 13 Q. And were you present when Chet Osborn was asked 14 about the LadarVision recall? Were you present? 15 A. Yes, I was. 16 Q. And do you recall Chet Osborn being asked about 17 what was the differentiation between machines that 18 apparently had the same software and the same 19 make-up and the same model number where in a 20 series of serial numbers, a few would be recalled, 21 and they'd skip one or two, and then they'd recall 22 a few more. Do you recall a question along those 23 lines? 24 A. No, sir. 25 MR. BROWN: Objection. Objection to the 161 1 form. Mischaracterization. 2 THE WITNESS: Yes, I do. 3 Q. (BY MR. HARRIS) In your opinion, is there any 4 problem in not knowing what the criteria for the 5 recall was? 6 MR. BROWN: Objection to the form. 7 Foundation. 8 THE WITNESS: Well, I was surprised that, you 9 know, given his position, that he didn't know. 10 You know, I mean, it should have been easy. I 11 mean, I don't know how easy, but it was something 12 he should have been able to tell us, I would have 13 thought. I mean, he was the manager of that 14 group. So I was surprised that he didn't know the 15 basis for that. Somebody should know, and I would 16 have thought he would know, but -- 17 Q. (BY MR. HARRIS) And did you understand him to be 18 in charge of all their maintenance in the United 19 States of these Alcon Autonomous LadarVision 20 systems? 21 MR. BROWN: Objection to the form. 22 THE WITNESS: That's correct. 23 Q. (BY MR. HARRIS) And what, if anything, would be 24 suggested to you if the, if the evidence shows 25 that the machines are identical through the serial 162 1 numbers as to their software and as to their build 2 and as to any significant aspects, and some are 3 recalled and some are not for equipment they all 4 have, what, if anything, would be suggested by 5 that? 6 MR. BROWN: Objection to the form. 7 Foundation. Speculation. Lack of expertise. 8 THE WITNESS: Good question. Well, either it 9 means that there's some feature about the recall 10 that we don't understand that was specific to 11 certain models and not others. 12 Q. (BY MR. HARRIS) And let me interrupt that long 13 enough to say that Chet Osborn, head of technical 14 service, doesn't understand, either, true? 15 MR. BROWN: Objection to the form. 16 Mischaracterization. 17 THE WITNESS: Or that some of the ones that 18 should have been recalled weren't? I mean, and I 19 don't know which of those two interpretations is 20 correct because I don't have enough information. 21 Mr. Osborn didn't provide any, so he didn't seem 22 to know, which was puzzling, but I don't know what 23 to conclude. I have nothing more to really add to 24 that. 25 Q. (BY MR. HARRIS) Now you were asked earlier about 163 1 device tampering. And it was at least suggested 2 that Dr. Will might have done some device 3 tampering which might be a criminal offense. Once 4 Alcon learns of device tampering, it is duty bound 5 to report that to the FDA? 6 A. Yes. 7 Q. And do they have some lag time like, you know, 8 two, three years later or are they supposed to do 9 at as soon as they hear about it or what's the 10 rule? 11 A. Contemporaneous. I mean, device tampering is a 12 problem. Produces an adulterated product. And we 13 had to really -- when I, one of the most 14 fascinating -- I get a chance to talk about my 15 career a little bit occasionally. 16 One of my most fascinating periods, when you 17 spoke of the, there was a period during which 18 there were folks using -- remember when I said 19 there were locked out devices? The early Visx 20 machines were locked out? 21 Q. Sure do. 22 A. There was a period where there were so-called 23 Bermuda cards used to unlock some of the Visx 24 machines. That is, essentially some clever 25 entrepreneur has figured out a way of unlocking 164 1 Visx's code, and they would have the docs send 2 their cards down to Bermuda, and then the guy down 3 there would manufacture cards that would open up 4 the software so that the docs could use it for 5 higher myopia treatments. 6 And I had a, head of a large -- name of the 7 company. They finally got consent decree against 8 them. They called me up and said, I heard you, 9 Lars, I heard you talked about -- their lawyer 10 actually called me and said, I heard you talk 11 about Bermuda cards as being illegal. If I had a 12 stack of them here -- I'm sitting with the head of 13 this clinic -- and if I had a stack of them here, 14 would that be a problem? And I said, you betcha. 15 I said, it's illegal. And I have, now I have to 16 report that to our Office of Compliance. Not only 17 to the Office of Compliance, but I reported it to 18 an artificial of criminal investigation, and it 19 was a really a big deal. 20 It was not a -- it's a big deal. You don't 21 want to be in that. So, yeah, I mean, the device 22 tampering is something that the agency gets -- the 23 Office of Criminal Investigation loves it 24 because -- 25 Q. (BY MR. HARRIS) So would it be a problem to sit 165 1 on the information for two or three years and then 2 suggest it later in a deposition? Or is it 3 supposed to be done right away? 4 MR. BROWN: Objection to the form. 5 THE WITNESS: It's -- I cannot imagine a 6 reason why would sit on that information. If it 7 was an adulterated product that you manufactured, 8 you would want the agency to know it right away to 9 shed any responsibility that you had in modifying, 10 contributing to this adulteration. So, yeah, 11 there's a delay would not be a good thing. 12 Q. (BY MR. HARRIS) You were also asked a question 13 about, that suggested Dr. Will was using, using 14 the LadarVision machine in an off-label use. Do 15 you recall that question? 16 A. Yes. 17 Q. And I know you don't know whether he uses that or 18 not in an off-label. You made that clear. If you 19 did and Alcon found out about that, are they 20 supposed to report that right away? 21 MR. BROWN: Objection to the form. 22 THE WITNESS: That's a little bit of a gray 23 area in terms of when to report it. 24 Q. (BY MR. HARRIS) Yes. 25 A. Because off-label use is, I mean, we knew from the 166 1 beginning, and we -- in fact, may, we understood, 2 the law allowed doctors to take this machine and 3 in their best clinical judgment use it on patients 4 that didn't qualify in the clinical trial, but on 5 their own. That's why you have that precaution 6 section in the front. That's why you have the 7 warning section in the front, so the doc on his 8 own or her own when they're treating off-label. 9 But, so I don't know that the company has a 10 responsibility to report in an early time frame. 11 Q. Yes. 12 A. Certainly -- unless there was some bad outcome. 13 But certainly, they should be keeping track of it, 14 and they should be reporting it to the agency from 15 time to time, probably in annual reports or 16 something like that. And I have no idea if that's 17 been done. 18 Q. If Alcon is going around saying that Dr. Will's 19 off-label uses may be causing its high retreatment 20 rate or his problems with his patients, is that 21 something that should be reported? 22 MR. BROWN: Objection to the form. 23 THE WITNESS: Sorry for the delay in 24 answering. I haven't fallen asleep. I was trying 25 to think through the question. That's a little 167 1 murky to me only because it's sort of after the 2 fact. I mean, that the, that Alcon is making 3 these claims, and I -- you know, if Alcon is 4 already reported in its annual reports and is 5 keeping track of off-label. Of course, they may 6 have met their obligations with regard to dealing 7 with adverse events, you know, claiming that 8 Dr. Will retreatment rates were essentially due to 9 off-label. 10 It doesn't absolve Alcon from its other 11 responsibilities but doesn't necessarily implicate 12 them in not doing what they should have done, 13 either. So I don't know that it's necessarily an 14 issue. Sorry to be so vague about that. 15 Q. Well, let me rephrase a little bit then. If Alcon 16 subjectively by its own judgment concludes that 17 Dr. Will or any other doctor's off-label use is 18 causing some harm to the patient or some adverse 19 result to the patient, is that something they 20 should report as soon as they subjectively believe 21 that? 22 MR. BROWN: Objection to the form. 23 THE WITNESS: If these -- you know, there are 24 two ways you can look at that. I mean, if there 25 were losses of best expected cure, if there were 168 1 induced astigmatisms that are associated with the 2 retreatment rates or if there were multiple 3 retreatment rates that were locked into that, when 4 you unlock that detail and look at those, what 5 really happened? I mean, if, if there are bad 6 outcomes to those patients, in addition to the 7 overall retreatment rate having been a, beyond 8 what was the approved rate, then I think there 9 would be some additional obligations on the 10 company, but the devil is in the details there. 11 You have to look. 12 It may be that a portion of any particular 13 surgeon's practice was due to his -- his 14 retreatment rates may be due to the fact that he 15 retreated some patients that were from a different 16 machine, from someplace else, not even in his own 17 clinic. It could be due to some that he used in 18 his own judgment to treat off-label. It could be 19 due to overcorrections. Could be due to 20 undercorrections. All of these are factors. 21 The overall rate, when it's really high, 22 suggests a problem. It doesn't identify which 23 problem. And it's Alcon's responsibility, as it 24 is other manufacturers, to ferret out which in 25 that mix. 169 1 Q. But in our scenario I was asking you about, of 2 course you'd have to keep statistics in order to 3 judge whether that's a problem, wouldn't you? 4 MR. BROWN: Objection to the form. 5 THE WITNESS: Yeah, you'd have to keep -- 6 Q. (BY MR. HARRIS) And if you're not keeping those 7 statistics, Alcon is not really in a position to 8 make a judgment, to fairly make a judgment like 9 that, are they? 10 MR. BROWN: Objection to the form. 11 THE WITNESS: That's correct. 12 Q. (BY MR. HARRIS) Now, Doctor, I want you to assume 13 with me that it turns out that none of these 14 things are missing here that you say you'd like to 15 have turn out to be exculpatory for Alcon. In 16 other words, it turns out that all these facts 17 that you've described about them not reporting 18 things and the conclusions you made all turn out 19 to be just exactly as you say they are, with no 20 exculpatory information coming into the picture. 21 If you knew those facts and you were licensing 22 this machine, would you license it? 23 MR. BROWN: Hold on a second. Would you read 24 that back? 25 (Whereupon the court reporter read back 170 1 the question beginning on Page 166 Line 2 4.) 3 MR. BROWN: Objection to the form. Also 4 calls for speculation. 5 THE WITNESS: Let me ask for clarification. 6 Are you saying because sometimes language is a 7 little bit -- 8 MR. HARRIS: Sure. No problem. 9 THE WITNESS: Complicated. And I love your 10 accent, but sometimes my ears don't quite process 11 it. Are you asking me that if I were at the FDA 12 and I saw this information and I didn't find any 13 exculpatory information, that is information that, 14 that I've caveated, my concerns with? 15 Q. (BY MR. HARRIS) Yes. 16 A. That sort of said, yes, in fact, Alcon did do the 17 report and they did do this, they had -- and if I 18 saw that information as presented, I would, I 19 doubt whether it would be an approved machine. I 20 doubt whether I would, I would doubt as a branch 21 chief that I would have said, go ahead with the 22 approval. I would have held it up and I would 23 have said, "Solve these problems." Tell me what's 24 going on before we go forward. 25 Retreatment rate, in itself -- I mean, I did 171 1 that explicitly with regard to retreatment rates. 2 The retreatment rates came in. Even if they were 3 gross retreatment rates and they came in like 4 this, we wouldn't let it go forward. So I think, 5 I guess, again, if, you know, it assumes there's 6 no additional information. 7 Q. Yes. That's the assumption you want you to make? 8 A. By Alcon. I have not seen their internal 9 processes. I have not seen their reports to the 10 agency. It's hard to know that this information 11 is going to be -- I need to leave that one. "I 12 don't know what I don't know" to quote Donald 13 Rumsfeld. I hate to do that. But -- 14 Q. All right. And if you were back in your old 15 position at the FDA and it came to your attention 16 that Alcon was not keeping track of treatments and 17 retreatments in a meaningful way, would you order 18 them to do so? 19 MR. BROWN: Objection to the worm. 20 THE WITNESS: Yeah, they would have to, they 21 would have to provide that detailed information. 22 And in fact, they would, typically what they 23 did -- again, to be fair to Alcon, they would have 24 to do what would they referred to as an accurate 25 retreatment rate. It would have to -- analyze 172 1 those gross retreatment rates and say, the gross 2 retreatment rates were due to such-and-such and 3 such-and-such, and here's how many were due to 4 overcorrections. Here's how many were due to 5 undercorrections. Here's how many were due to 6 this and that and so forth. So they would have to 7 be very detailed analysis before that would go 8 forward. 9 As a matter of fact, we had a very unusual 10 situation with a doc. I don't know if any of you 11 are close enough to this business to know. There 12 was a doctor by the name of Fred Cramer in 13 Pennsylvania that built his own LASIK machine, 14 fascinating guy. 15 Q. No. 16 A. And one of the challenges we had with him, he 17 created a lot of heartburn at the agency because 18 he was an engineer as well as a doctor, and he 19 built this himself with the help from some 20 friends. And he conducted his own preclinical 21 trial prior to FDA giving him the authority to do 22 so, and we banged on him a lot. And he challenged 23 us. He had some really good lawyers. He said, 24 well, you know, here's my clinical data. It 25 wasn't contained in a FDA approved IDE, but here's 173 1 an actual clinical trial that we did, and it was 2 an ugly clinical trial in the sense that it didn't 3 have, it wasn't done in accordance with the 4 guidance that we have here. 5 Q. Right. 6 A. But this was a very bright doc, a very 7 conscientious fellow, and we put him through the 8 ringer, and he had retreatment because he did it 9 as a doctor. He said he -- 10 Q. Sure. 11 A. -- he was doing, in his view, he had built the 12 machine for his patient, so he said, FDA, you shut 13 me down if you think I can't build a machine for 14 my patients. And so we said, well, we didn't want 15 to fight with the doctor in public, so basically 16 what we told him to do, you present us with all 17 that information, and then we'll look at the data, 18 and we'll come through that and if your data come 19 up to snuff -- and so it was a natural example of 20 a situation where he had retreatment rates that 21 were high, but he was able to tease out and 22 particular subset where the retreatment rates were 23 acceptable -- 24 Q. Yeah. 25 A. And so we actually went through that exercise. So 174 1 I don't -- you know, it was not pretty. So it can 2 be handled, but it, it would be, it would be done, 3 a big delay in getting the product on the market 4 if you came in with that kind of wide range of 5 retreatment rates. Plus the other issues. 6 Q. But in any event, it suggests investigation by 7 both you and, both the FDA and the company? 8 MR. BROWN: Objection to the form. 9 THE WITNESS: (Nodding head up and down.) 10 MR. BROWN: Was there an answer there and 11 what's, what's what your question? Was Dr. 12 Kremer's experience, which is all fascinating 13 relate? I just don't understand the question, and 14 I don't think Dr. Waxler gave you an answer. 15 MR. HARRIS: I'm satisfied with his answer. 16 Thank you. 17 MR. BROWN: I don't think he answered. 18 Q. (BY MR. HARRIS) Now, suppose if you were back on 19 the FDA in your old position, it came to your 20 attention that Alcon was not keeping track of 21 unscheduled maintenance in any meaningful or 22 statistical way, would you order them to start 23 doing so? 24 MR. BROWN: Objection to the form. Calls for 25 speculation. Asked and answered. 175 1 THE WITNESS: That typically would come to 2 the Office of Compliance. 3 Q. (BY MR. HARRIS) Yes. 4 A. Within CDRH. And I personally wouldn't directly 5 have been involved with it, but knowing what I 6 know now about it -- I've learned a lot about 7 compliance issues since. 8 Q. Right. 9 A. I, somebody there would have, would have gone back 10 to the manufacturer and said, you know, your, it's 11 certainly in the first two-year period if there 12 were, if they did not report in a schedule manner, 13 and I don't, I have no idea whether they did or 14 didn't, in those first two annual reports. If 15 they didn't report them, that would have been a 16 problem. Someone should have picked that up. And 17 if subsequent to that they weren't keeping, the 18 manufacturer wasn't keeping track of 19 unscheduled -- 20 Q. Yes. 21 A. -- maintenance and Office of Compliance became 22 aware of it, now how they become aware of it would 23 be totally complicated. So somebody would have to 24 tell them from inside the company. 25 Q. Just assume with me. 176 1 A. But if that happened, then, sure, there would be a 2 question as to, someone would be questioning Alcon 3 about, you know, how many -- and tell you what 4 goes on in that drill is that the agency 5 inspectors come in and they start, oh, you have a 6 problem with unscheduled maintenance records. 7 Let's see what else problems you have. And they 8 start pulling at these matters and it starts to 9 unravel. And that's typically what -- 10 Q. And when you say keeping track of unscheduled 11 maintenance, do you merely mean having it written 12 down somewhere or do you mean analyzing it in some 13 meaningful, statistical way? 14 MR. BROWN: Objection to form. 15 THE WITNESS: No, using it to inform 16 management that there is or isn't a problem with 17 the product. That's the whole point of keeping 18 the information, not just to store it. 19 Q. (BY MR. HARRIS) And does that same principle 20 apply to treatment rates as well as retreatment 21 rates? 22 MR. BROWN: Objection to the form. 23 THE WITNESS: Of course. 24 Q. (BY MR. HARRIS) So the mere fact that you 25 somewhere somehow have treatment rates and 177 1 retreatment rates or could get them if you wanted 2 them to, does that meet the requirement? 3 MR. BROWN: Objection to the form. 4 THE WITNESS: No. You have to have a, in 5 their quality system manual, they should have 6 standard operating procedures for how to handle 7 those, that information and lay out exactly what 8 they do and how they make their decisions related 9 to that information. It's not there just to 10 occupy the record space. 11 Someone -- in fact, typically, my experience 12 that a quality systems manager -- and I don't know 13 who that is, I don't recall who that is at 14 Alcon -- is supposed to meet rather regularly to 15 ascertain, you know, what's going on with the 16 quality of the product in all of its various 17 aspects. So use that as base data to say you're 18 having a problem with this subcomponent or this 19 subsystem or everything is hunky dory or whatever. 20 So that would be a typical routine, ongoing 21 operation of quality, sort of feedback as it were 22 to make sure the product stays in compliance. 23 Q. (BY MR. HARRIS) Right. 24 MR. HARRIS: I think that's all the questions 25 I have. 178 1 FURTHER EXAMINATION BY MR. BROWN 2 Q. You don't know one way or the other what Alcon 3 internally tracks or trends, correct? 4 A. That's correct. 5 Q. You don't know if they track their unscheduled 6 maintenance or not, correct? 7 A. I only know that I've heard that they didn't know 8 what unscheduled maintenance was. 9 Q. Well, you only heard what one employee of Alcon 10 testified in response to questions that Mr. Harris 11 asked in Orlando that you sat in on, correct? 12 A. He was the manager of that group. 13 Q. That's not my question. My question is, what you 14 heard was answers to questions that Mr. Harris 15 asked in certain forms during a deposition, 16 correct? 17 A. Fair enough. 18 Q. Okay. You don't know one way or the other whether 19 or not Alcon tracks unscheduled maintenance, 20 correct? 21 A. That's correct. 22 Q. And you don't know one way or the other what Alcon 23 reported in 1999 or 2000 in their annual reports 24 to FDA what unscheduled maintenance, correct? 25 A. That is correct. 179 1 Q. And you don't know one way or the other, for any 2 time from 1999 to the present, what type of trend 3 analysis Alcon has or hasn't done internally on 4 any issue relating to LadarVision, correct? 5 A. That's correct. 6 Q. What is the manufacturers' obligation to respond 7 to a physician's complaints if the physician 8 refuses to provide Alcon with patient data or 9 information? 10 A. If they refuse to provide it. 11 Q. Yes, if they refuse. 12 A. Oh, good question. Let me think a moment on that. 13 Q. Please, think. 14 A. Forgive me for taking so long. 15 Q. Dr. Chotiner hypothetically says, I have some 16 problems here, Alcon. What are you going to do 17 about them? And Alcon says to Dr. Chotiner, give 18 me your patient records on these days with respect 19 to these issues. And Dr. Chotiner says, I'm not 20 going to give you that. 21 That's a hypothetical. What's the 22 manufacturer's obligation at that point to do 23 follow-up with that doctor who refuses to provide 24 patient information? 25 A. Well, I, that's an interesting quandry for the 180 1 company actually. Interesting question. If -- 2 company is certainly obliged to investigate and 3 demonstrate that it has made all efforts to 4 investigate. If truly the doc is not, refuses, 5 and I don't mean one time request and somebody 6 refused, but if, you know, I would think that if 7 the doc would totally refuse repeated requests to 8 provide that information to verify whether or not 9 there was, in fact, an adverse event, that, I 10 don't know that the agency would fault the, fault 11 Alcon for that. 12 Q. And I just use, by the way, this is a 13 hypothetical. I just used Dr. Chotiner's name 14 because he's on page 2 of my notes here. That 15 would go for any doctor, correct? 16 A. Yeah. 17 Q. And Alcon only finds out about overcorrections or 18 undercorrections that occur in a physician setting 19 where the physician reports that data, correct? 20 A. I'm sorry. Say that again? 21 Q. If Dr. X on any given day has two overcorrections, 22 Alcon only knows that if Dr. X reports that to 23 Alcon, correct? 24 A. Oh, sure. 25 Q. Alcon is not there out there at every physician 181 1 site where there are LadarVision machines looking 2 and seeing on a day-in and day-out basis what 3 results are the physicians getting, correct? 4 A. That's correct. 5 Q. So Alcon only knows things if the physicians 6 report it to Alcon, correct? 7 A. That's correct. 8 Q. That's the same with every manufacturer of an 9 excimer laser, correct? 10 A. Correct. 11 Q. What review and analysis did Alcon do on the beam 12 translator issue to determine whether a recall was 13 necessary? 14 A. What did you do? 15 Q. No, what did it do? You don't know? 16 A. I only know scattered pieces of information. 17 Q. Provided to you by Dr. Will, correct? 18 A. And also on some of the threads of emails that 19 were also provided by Dr. Will, not communications 20 with him. 21 Q. So you only know Dr. Will related commentary on 22 beam translators. You don't know what Alcon did 23 or didn't do, correct? 24 A. That's correct. 25 Q. And you don't know what Alcon has done or hasn't 182 1 done with respect to tracking or responding to 2 complaints about decentration, correct? 3 A. That's correct. 4 Q. And you don't know what Alcon has done to respond 5 to or track internally complaints about induced 6 astigmatism, correct? 7 A. That's correct. 8 Q. Or any other issue for that matter? 9 A. That's correct. 10 Q. Are the folks at Emory who Mr. Harris told you 11 have retreatment rates of X and Y percent showing 12 up on the billing document committing some sort of 13 a malpractice or acting unethically by continuing 14 to use LadarVision on patients in their practice? 15 A. I have no idea what they're doing. I don't know 16 if they're continuing. I have no idea what's 17 going on. 18 Q. Mr. Harris asked you about Emory's retreatment 19 rates that show up on that billing document. 20 Remember that? 21 A. Yeah. 22 Q. And he said something like 23 percent for some 23 given year period. You remember that? 24 A. Yeah. 25 Q. And so if Emory tracks how many of patients of 183 1 those they're retreating and they see that it's 2 23 percent and they continue to use LadarVision on 3 their patients, are they committing malpractice? 4 A. Well, I'm not an attorney. So I wouldn't really 5 know, but I don't even know if they are continuing 6 to use it is what my point was. 7 Q. Well, when they were using. Well, let's take it a 8 different way. They at least were using it in 9 2001 and 2002 because there's numbers on that 10 billing record, correct? 11 A. I see your point. 12 Q. You understand that? 13 A. Yeah. 14 Q. So in 2001, what Mr. Harris told you was there was 15 percentage higher than 10.5, correct? 16 A. Right. 17 Q. So they knew in 2001 they had a percentage higher 18 than 10.5, correct? 19 A. I see your point. 20 Q. And then 2002, they continued to use it on their 21 patients, correct? 22 A. Uh-huh. 23 Q. Is there anything unethical about that in your 24 view? 25 A. Well, it may be problematic, actually. It might 184 1 be. The fact that they're problematic doesn't 2 mean that Alcon's not -- 3 Q. My question is, do you think for every practice in 4 that billing record that appears to show a billing 5 retreatment rate of above 10.5, if those practices 6 know what their rates are and continue to use 7 LadarVision, does that create practice specific 8 problems in your view? 9 A. Probably. 10 Q. So they all may be acting unethically? 11 A. Yeah. 12 Q. Was that a yes? 13 A. Probably, yeah. I mean, good question. 14 Q. If you did, in fact, learn or determine that Dr. 15 Will tampered with his device, would that raise 16 any concerns with you about relying so extensively 17 in your report on factual assertions provided to 18 you by Dr. Will? 19 A. It would depend on when this occurred in 20 relationship to other retreatment rates, other 21 kind of problems and if these changes were made 22 with the authority or approval or in concert with 23 Alcon as to whether, in fact, it was tampered or 24 not. I don't really know enough about what 25 actually happened to know really what -- I don't 185 1 even know specifically what was done. 2 MR. BROWN: That's all I have. 3 FURTHER EXAMINATION BY MR. HARRIS 4 Q. (BY MR. HARRIS) And if the doctors were never 5 told by Alcon that 10.5 percent, operating above 6 10.5 percent retreatment rate was a problem, they 7 might not even know that, true? 8 MR. BROWN: Objection to the form. 9 Q. (BY MR. HARRIS) Not to get sent out by the FDA to 10 them to tell them, look out, 10.5 percent does it? 11 MR. BROWN: Objection to the form. 12 THE WITNESS: That's a good point. That's 13 true. It's really an interesting situation where 14 the, both the panel and Dr. Rosenthal explicitly 15 stated in their panel meeting that the retreatment 16 rate was an important part, and it was required of 17 all manufacturers in response to panel members 18 questions, and it was in the labeling, and it is 19 in the labeling for all the machines, not just 20 Alcons. 21 And the fact that neither Alcon nor 22 apparently the agency or apparently the docs have 23 emphasized that feature of the requirements 24 doesn't mean it's not a problem. It means that 25 there's been some serious problem in communication 186 1 about the importance of retreatment and a lack of 2 understanding of, of paying attention to it. 3 And I think the manufacturer, you know, it's 4 their machine. I mean, to be honest with you, I 5 mean, the manufacturer incurs a heavy 6 responsibility, and I feel for them because they 7 really, you know, anybody can use their machine. 8 They sell it to people. They don't -- they can't 9 keep track of their outcomes. It's quite true. 10 They depend on these docs to report to them. 11 But they also -- those docs depend on 12 accurate information from the company about what 13 was expected in terms of, you know, what's an 14 acceptable retreatment rate? And I don't know 15 from firsthand knowledge what, what Alcon 16 communicated to its docs about what is an 17 acceptable retreatment rate. 18 Q. And suppose with me further that representatives 19 of Alcon actually lied to the doctors and told 20 them that a retreatment rate above 10.5 percent 21 wasn't unacceptable. The rates that doctors were 22 quoted above, that was no problem? Wouldn't that 23 further be a problem for the doctors? 24 MR. BROWN: Objection to the form. 25 THE WITNESS: Well, I mean if, if those 187 1 statements are accurate, what you said -- 2 Q. (BY MR. HARRIS) Right. 3 A. Then yeah, that's a problem because they're 4 misleading the users into thinking that these, 5 it's not a big deal to have a retreatment rate 6 above a certain value. 7 Q. And isn't that exactly what Chet Osborn said to us 8 under oath down in Florida? Didn't he say, 9 retreatment rate doesn't matter? Didn't he say it 10 doesn't matter? 11 MR. BROWN: Objection to the form. 12 Mischaracterization. 13 THE WITNESS: He said retreatment rates, if I 14 remember correctly, what he said was that 15 retreatment rates depended on the site. And 16 exactly why it depended on the site was a little 17 bit vague. But he said it was not a fixed number, 18 and he wasn't aware of any fixed number that was 19 for the approved device, which was puzzling to me 20 since it's in the labeling. 21 Q. (BY MR. HARRIS) And didn't Chet Osborn, the head 22 of technical services, under oath say that so far 23 as he knew, Alcon didn't even keep track of 24 retreatment rates on a year-to-year basis, didn't 25 he say that? 188 1 MR. BROWN: Objection to form. 2 THE WITNESS: That is correct. 3 Q. (BY MR. HARRIS) And didn't Rick Potvin, who does 4 statistical work for them, and does, and does 5 retreatment rates versus treatment rates for 6 individual doctors say that he didn't do any 7 statistical data involving treatment rates and 8 retreatment rates for Alcon over the machines 9 overall? Didn't he say that? 10 MR. BROWN: Objection to the form. 11 Mischaracterization. 12 THE WITNESS: I'm not sure that's quite 13 accurate. Say that again? 14 Q. (BY MR. HARRIS) Didn't Rick Potvin, who was in 15 charge of Alcon statistics, say that, say that he 16 was unaware of whether Alcon kept any statistics 17 for all their machines from year to year for 18 treatment rates and retreatment rates? 19 MR. BROWN: Objection to the form. 20 Mischaracterization. 21 THE WITNESS: I think he said that at the 22 same time he was saying that he used -- he was 23 hired to look at retreatment rates, and he used 24 the billing data to get his first crack at the 25 retreatment rates. 189 1 Q. (BY MR. HARRIS) Right. 2 A. But I think in response to a question that you 3 asked with regard to retreatment rates prior to 4 his coming on the scene, that he wasn't aware of 5 any effort to keep track of retreatment rates. I 6 think that's what he said, but my memory may not 7 be serving me well. 8 Q. Yes, yes. 9 A. And I haven't seen the written form of that 10 deposition, so I don't really know, have no way of 11 checking. 12 Q. And isn't it up to Alcon to inform the doctors if 13 retreatment rates above 10.5 percent should be 14 something they should look for and should be 15 something they should be concerned about. Isn't 16 it up to Alcon? 17 MR. BROWN: Objection to form. 18 THE WITNESS: I would have thought that Alcon 19 would have, would have set, made explicit what the 20 expected retreatment rates are, and that should be 21 based upon the clinical trial that they did which 22 provided the basis. 23 And if Alcon wanted to define retreatment 24 rates in a more specific way, then they had the 25 freedom to do that in their standard operating 190 1 procedures within their company. They could have 2 said, well, gross retreatment rate is 3 such-and-such. It's in the billing record. But 4 an actual retreatment rate is the actual 5 comparison of that doc and then use those codes 6 that are fed back to Alcon to segregate, to keep 7 track of the actual retreatments that were 8 occurring so they could know what the performance 9 of their machine is. 10 And basically, it's my machine that I've put 11 out there performing as approved? I mean, is it 12 actually doing the intended correction? Is it 13 achieving the intended correction? That's really 14 what we're talking about. And if it's achieving 15 the intended correction, then it's effective. If 16 it's not achieving the intended correction, it's 17 not effective and may be a problem. May be a 18 problem in the sense that some of those, some of 19 those repeats may be due to overcorrections which 20 a serious problem. It may be due to loss of the 21 best corrective visual acuity. They may be due to 22 any number of things that are problematic. They 23 may also be due to other things, but you don't 24 know that until you actually keep track of the 25 information. 191 1 Q. And according to the retreatment rates that you've 2 gone over, this machine is not achieving the 3 intended correction, is it? 4 MR. BROWN: Objection to the form. First, 5 I'm going to object because this is all A, outside 6 the scope of proper redirect in that the recross 7 was very narrow. These questions have been asked 8 and answered for 90 minutes with Dr. Waxler on the 9 direct to begin with. And Mr. Harris is just 10 trying to get the same testimony on the record 11 umpteen times so that we have a lengthier 12 transcript. So I object to this whole line. 13 Q. (BY MR. HARRIS) You can answer. 14 A. Now I forgot the question. Excuse me. 15 MR. BROWN: You've only answered it 17 times 16 already. 17 Q. (BY MR. HARRIS) Don't the retreatment rates 18 indicate that this machine is not achieving the 19 intended correction, at least in a significant 20 amount of cases? 21 MR. BROWN: Same objection. 22 THE WITNESS: I mean, by definition. I mean, 23 you know, and one needs to seek further to find 24 out why, but that's the first answer. It's a 25 problem. And the specific problem, I don't know, 192 1 because I don't have a full set of information. 2 Q. (BY MR. HARRIS) Would it surprise you to learn 3 that there are no paper documents of any variety 4 supplied to doctors, not their training documents, 5 not letters, not memos, not emails, not of any 6 variety that tell the doctors to look out for 7 retreatment rates above 10.5 percent such as 8 you've described, nothing. Would that surprise 9 you to learn that? 10 MR. BROWN: Objection to the form. 11 THE WITNESS: Yeah, I would have thought that 12 that would be, given the emphasis that we had on 13 retreatments, that it would, the implications of 14 retreatments, that that would be something that 15 there would be at least a mention, there would be 16 some sort of an implication since it's in the 17 labeling, you know, to be alerted to the fact that 18 there was a certain retreatment rate above which 19 is, it's a problem. 20 Q. (BY MR. HARRIS) Would it surprise you to learn 21 that numerous doctors have been told by 22 representatives of Alcon that retreatment rates 23 are not important? 24 MR. BROWN: Objection. 25 Q. (BY MR. HARRIS) They're not a significant part of 193 1 the treatment process? 2 MR. BROWN: Objection to form. 3 THE WITNESS: I would be surprised. 4 MR. HARRIS: That's all the questions I have. 5 MR. BROWN: Thank you. 6 (WHEREUPON, the deposition was concluded 7 at 1:00 p.m.) 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 194 STATE OF NORTH CAROLINA C E R T I F I C A T E COUNTY OF MECKLENBURG I, Karen K. Kidwell, RMR, CRR, Registered Professional Reporter and Notary Public, do hereby certify that MORRIS WAXLER, Ph.D. was duly sworn by me prior to the taking of the Deposition; that said Deposition was taken and transcribed under my supervision; and that the foregoing 193 pages are a true and accurate transcription of the testimony of said deponent. I further certify that review and signing of the transcript by the witness was waived. I further certify that the persons were present as stated. I further certify that I am not related to, of counsel for, or in the employment of any of the parties to this action. IN WITNESS WHEREOF, I have hereunto subscribed my name, this the 22nd day of November, 2004. ______________________________ Karen K. Kidwell, RMR, CRR Registered Professional Reporter, and Notary Public My Commission Expires: June 15, 2008