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.