0001 1 IN THE COURT OF COMMON PLEAS 2 CUYAHOGA COUNTY, OHIO 3 4 SHANNON SULLIVAN, et al., 5 VS. CASE NO. CV-09-697617 6 THE CLEVELAND FOUNDATION. 7 8 DEPOSITION OF ROBERT CHABON, M.D. 9 APRIL 20, 2011 10 11 DEPOSITION OF ROBERT CHABON, M.D., produced at 12 the instance of the Defendant, The Cleveland Clinic, in 13 the above-styled and numbered cause on the 20th day of 14 April, 2011, at 12:14 p.m., before Deelana Johnson, 15 Certified Shorthand Reporter for the State of Oregon, 16 reported by machine shorthand, at the offices of 17 Beovich, Walter & Friend, 1001 S.W. Fifth Avenue, Suite 18 1200, Portland, Oregon 97204, pursuant to Notice of Oral 19 Deposition, and in accordance with the Ohio Rules of 20 Civil Procedure. 21 22 23 24 25 0002 1 A P P E A R A N C E S 2 3 ON BEHALF OF THE PLAINTIFFS 4 SHANNON SULLIVAN, ET AL.: 5 6 MISHKIND LAW FIRM CO., L.P.A. 7 BY: Howard D. Mishkind, Esquire 8 David A. Kulwicki, Esquire 9 Skylight Office Tower 10 1660 West Second Street, Suite 660 11 Cleveland, Ohio 44113 12 (216) 241-2600 13 (Appearing via videoconference) 14 15 ON BEHALF OF THE DEFENDANTS 16 THE CLEVELAND CLINIC FOUNDATION: 17 18 ROETZEL & ANDRESS, L.P.A. 19 BY: Joseph E. Herbert, Esquire 20 Anna Moore Carulas, Esquire 21 1375 East Ninth Street 22 One Cleveland Center 23 Cleveland, Ohio 44114 24 (216) 623-0150 25 (Appearing via videoconference) 0003 1 INDEX OF PROCEEDINGS 2 ROBERT CHABON, M.D., DEPOSITION PAGE 3 EXAMINATION BY MR. HERBERT 4 4 5 * * * 6 7 INDEX OF EXHIBITS 8 EXHIBIT DESCRIPTION OF EXHIBIT PAGE 9 A Chabon's July 22, 2010 Report 10 B Chabon's January 31, 2011 Report 11 C Deposition Transcripts 12 D EHRA Scientific Statement 13 E Medical Articles 14 F Medical Records 15 G Cleveland Clinic Consent Materials 16 H Patient Care Partnership Materials 17 I Letters of Opinion 18 J Hong Materials 19 K ThermoCool Materials 20 L Handwritten List of Materials 8 21 Reviewed 22 (Exhibits A - K marked prior to commencement 23 of the deposition) 24 * * * 25 0004 1 P R O C E E D I N G S 2 (April 20, 2011, at 12:14 a.m.) 3 ROBERT A. CHABON, M.D., 4 having first been duly sworn, testified as follows: 5 THE WITNESS: I do. 6 7 EXAMINATION 8 BY MR. HERBERT: 9 Q. Please state your full name for the 10 record. 11 A. Robert, middle initial S, last name 12 C-h-a-b-o-n. 13 Q. You understand that you have been 14 identified as an expert witness on behalf of the 15 plaintiff; is that true? 16 A. Yes. 17 Q. You also understand this is my only 18 opportunity to find out from you, under oath, what 19 your opinions are and the basis for those opinions, 20 true? 21 A. Yes. 22 Q. Is there any reason why you are unable to 23 proceed with the deposition today? For example, 24 you're not prepared, you're ill, you've got a 25 scheduling problem, anything like that? 0005 1 A. No. 2 Q. Before we started, I had you itemize for 3 the court reporter all the material that you brought 4 to the deposition today. And we've marked various 5 items as exhibits. And just for the record, as I 6 understand it, you've marked a group of depositions 7 that you brought with you as Exhibit C; is that 8 correct? I kept pretty good notes, so just confirm 9 as I read through. 10 A. Okay. Depositions are C, correct. 11 Q. And as I understand it, those are just 12 the depositions that you brought with you. You had 13 other depositions available to you that you reviewed 14 and relied upon in this case, but you didn't bring 15 them to the depo today; is that true? 16 A. I think there was only one deposition 17 that I've received that I didn't -- Well, no, 18 perhaps two. I did not bring Mrs. Sullivan's 19 deposition, and I did not bring Dr. Mereno's 20 deposition. And those were all of the depositions 21 that I've reviewed. 22 Q. Okay. Then Exhibit D is the consensus 23 statement, correct? 24 A. Correct. 25 Q. Exhibit E, there are a number of medical 0006 1 articles that you identified, correct? 2 A. Correct. 3 Q. And before we move on, other than the 4 articles that you had the court reporter mark as 5 Exhibit E, have you reviewed any other medical 6 literature in connection with this case? 7 A. I've reviewed a considerable amount of 8 medical literature in this case that I did not bring 9 with me. 10 Q. Would you be able to provide us with a 11 list of all the other articles that you reviewed in 12 this case and provide it to the court reporter? 13 A. I don't believe I can, because I've 14 reviewed so much material over a period of a year, 15 and I haven't kept a record of what I've reviewed. 16 I've reviewed it from various sources that I sought 17 out myself, and I don't think I have a list of it. 18 Q. Just so the record is completely clear, 19 you didn't keep a copy of anything, other than what 20 you brought to the depo with you? 21 A. I don't know for sure. I don't believe 22 that I have other articles that I kept a copy of, 23 but there may be. And if I have other articles, I'd 24 be happy to provide a list of those articles to you. 25 Q. And that's what I'm asking you to do. 0007 1 A. Yes. Whatever I have that I didn't 2 bring, I'll be happy to do that. 3 Q. Okay. And while we're on the topic, you 4 did not bring your complete file for this case, 5 correct? 6 A. I did not, that's correct. 7 Q. And as I understood it, before we 8 started, you mentioned that you didn't attempt to 9 bring all of the medical records, true? 10 A. I have a huge stack of medical records, 11 right. 12 Q. Again, I'm not being pejorative, but -- 13 A. I understand. I understand, that's true. 14 Q. In addition to the medical records that 15 you did not bring, what other items do you still 16 have in your possession related to this case that 17 you don't have with you here today? 18 MR. MISHKIND: Other than the 19 depositions that he identified? 20 MR. HERBERT: Right. 21 A. I don't know. I think most of what I 22 didn't bring, the vast bulk of what I didn't bring 23 was the entire medical record. I'm trying to think 24 if there's anything else, what else I didn't bring. 25 Off the top, I don't know. But again, I'll be happy 0008 1 to go back and look. And if you don't want me to 2 provide you with medical records that I didn't 3 bring, I can provide you with anything else I didn't 4 bring. I'll make a list of it. 5 BY MR. HERBERT: 6 Q. And you had suggested, before we started, 7 that you had sort of a list that itemized all your 8 things -- 9 A. I have a list of everything I've 10 reviewed. It's handwritten, but it's legible. 11 Q. Okay. Why don't we mark that as 12 Exhibit L. 13 (Exhibit L marked) 14 Q. Did you prepare any other documents or 15 summaries that you have in the room with you today, 16 that are not already marked? 17 A. I don't believe I brought, and I 18 certainly intended to bring, copies of the two 19 reports that I submitted to Mr. Kulwicki. I have 20 those; I'm sorry, I didn't bring them. I can, of 21 course, provide them for you. 22 (Discussion off the record) 23 BY MR. HERBERT: 24 Q. I'm going to ask you some background 25 questions, if I can. I had an opportunity to review 0009 1 what was purported to be a copy of your curriculum 2 vitae, and it was dated back in March of 2007. And 3 I wanted to ask, do you have an updated curriculum 4 vitae with you? 5 A. I don't think I have an updated 6 curriculum vitae, period. I think that that 7 curriculum vitae that you have is probably an 8 updated curriculum vitae. I may have something 9 updated, but I'm not aware of it. I'd have to go 10 into my computer and see if there's something that's 11 been updated. But there are no significant changes 12 in my curriculum vitae, except that I left the 13 Heartland Health System at the end of 2007. I 14 retired from the Heartland Health System at the end 15 of 2007. 16 Q. Okay. You are no longer in the active 17 clinical practice of medicine; is that true? 18 A. That is correct. 19 Q. All right. And is it also true that you 20 do not have an active license to practice law? 21 A. An active license to practice law? That 22 is correct. 23 Q. Not to be pedantic about it, but it's my 24 understanding that you've never been licensed to 25 practice law or medicine in the state of Ohio; is 0010 1 that true? 2 A. That is correct. 3 Q. Have you ever published in a 4 peer-reviewed journal anything that you believe to 5 be pertinent to the issues in this case, as you see 6 them? 7 A. I don't know. I don't think so. I have 8 a vague notion that I might have published something 9 relating to consent, but I don't believe it was in a 10 peer-reviewed journal. 11 Q. Okay. In the one article or the 12 authorship that you're speaking about, is that going 13 to be on your CV, even the old one? 14 A. Yes, it will on my CV. 15 Q. Okay. As it relates to the Code of 16 Federal Regulations, have you ever represented a 17 party in a state court, where the specific sections 18 of the Code of Federal Regulations that you cite in 19 your reports were at issue? 20 A. I don't believe so. 21 Q. In your work as a physician, have you 22 ever been involved, as a party in litigation, where 23 those specific codes of federal regulation were at 24 issue? 25 A. No. 0011 1 Q. Can you tell me the difference between a 2 regulation and a statute, if any? 3 A. Regulation is -- A statute is a law. I 4 mean, it actually is passed as a law and has the 5 force of law. Regulation is a rule that carries 6 authority and states what should be followed, what 7 procedures should be followed. 8 Q. The level of authority is not the same 9 between a statute and a regulation; is that much 10 true? 11 A. I have to think about it. I'm not sure. 12 I'm not sure I can answer that question directly. 13 Q. Thank you. You are not currently 14 admitted to practice law for any federal bar; is 15 that correct? 16 A. That's correct. 17 Q. And you are not employed as a hospital 18 administrator currently? 19 A. Currently, that's correct. 20 Q. You retired from Heartland in 2007. What 21 have you been doing since then? 22 A. I've been working. I'm of counsel to a 23 law firm in Washington, D.C. And I review medical 24 malpractice cases for attorneys in a number of law 25 firms across the country, and assist them primarily 0012 1 with preparation for cases. 2 Q. These law firms that you are consulting 3 for, these are primarily law firms that represent 4 injured parties, plaintiffs? 5 A. They are primarily plaintiffs, that's 6 correct. 7 Q. So in the breakdown in terms of that type 8 of work, is it 99 percent on behalf of the injured 9 party? 10 A. I don't think it's 99 percent, but I 11 think it's probably 90 percent or more. 12 Q. Okay. You've never held the position of 13 hospital administrator with any hospital in the 14 state of Ohio; is that true? 15 A. That's correct. 16 Q. And you don't hold yourself out as an 17 expert in cardiology? 18 A. I don't think I'm here today as an expert 19 in cardiology. 20 Q. Fair enough. Some of these questions are 21 along the lines of obvious things but, for the 22 record, I'm just going to ask them anyway, without 23 trying to belabor the point, hopefully. If I do 24 tend to belabor the point, don't be shy, let me 25 know. These guys sitting next to me will let me 0013 1 know too, I'm sure. 2 At any rate, as it relates to the 3 type of procedure that was done in this particular 4 case, above and beyond cardiology, you're not 5 proposing to offer an opinion regarding the standard 6 of care for a physician, such as Dr. Burkhardt, or 7 for healthcare providers who do this type of 8 procedure or assist in this type of procedure; is 9 that much true? 10 MR. MISHKIND: Objection to the form 11 of the question. 12 But you can answer. 13 A. Okay. I don't believe I'm here today to 14 offer an opinion as an expert in electrophysiology 15 or as an expert in cardiology. 16 Q. Exactly. I'm trying to cut to the chase 17 without asking you a bunch of little, tiny questions 18 that give each little role of the people involved. 19 Just so that we're on the same page, can we agree 20 that it was not your intention when you wrote your 21 report, nor your intention today, nor your intention 22 to come to trial and testify that anybody involved 23 in the care and treatment of Mr. Sullivan was below 24 accepted medical standards of care? 25 MR. MISHKIND: Objection. 0014 1 Q. Is that true? 2 MR. MISHKIND: Go ahead, Doctor, 3 A. I don't believe that's my purpose here 4 today. I don't believe that that's what I'm being 5 asked to do as an expert witness. 6 Q. Okay. So the answer to my question was 7 that's correct, you don't have that intention. 8 A. That's not why I'm here. 9 Q. Right, that's a good response. But just 10 so I'm clear, you are agreeing with me, you're not 11 intending to be a medical expert. 12 A. Well, I don't think that's why I've been 13 asked to come here today, correct. To that extent, 14 I'm agreeing with you, yes. 15 Q. And that's all I'm after. I mean, 16 obviously, I'm not trying to argue with you. I 17 don't know what they said to you, but I can ask you 18 questions about what your intentions are. And 19 that's all I'm trying to do. 20 A. Yes, I understand. 21 Q. Now, while we're sort of on that topic, 22 you mentioned that you didn't have any letters with 23 you today. Did you receive communications from 24 plaintiffs' counsel about this case before you wrote 25 the reports? 0015 1 A. I know I received letters that 2 accompanied records when the records were sent to 3 me, yes. 4 Q. Okay. And above and beyond, do you still 5 have those letters in your work file? 6 A. I don't think so. I don't normally save 7 those letters. 8 Q. Okay. But you, of course, will go back 9 and look. And if you have them, you will provide 10 them to the court reporter? 11 A. Yes, I will. 12 Q. If you have any other correspondence or 13 communications from plaintiffs' counsel that are in 14 writing, would you likewise have those in your 15 file? 16 A. If I did, I would. But I don't know that 17 I do. 18 Q. And if they're in your file, you would 19 likewise provide those to the court reporter so we 20 have an opportunity to look at those, correct? 21 A. Yes. I will do that, yes. 22 Q. Thank you. You noted a couple of times 23 that the medical records were voluminous. Did you 24 receive, to your recollection -- I know you didn't 25 bring it today, but to your recollection, any sort 0016 1 of summary of the events of the case, any chronology 2 or timelines or anything that was sort of an 3 abstract of what took place in the case? 4 A. No, I did not. 5 Q. Okay. Over various points in time, you 6 received, you know, information that we sort of 7 catalogued when we began this deposition. And some 8 of that, in terms of when you received it, is set 9 forth in your reports, but not all of it. The 10 correspondence, the transmittal letters, if you 11 still have them, you would agree with me, those 12 would show what you received and when you received 13 it, right? 14 A. If I still have them, yes, they would 15 show that. But I don't know that I have them. I 16 suspect I don't. 17 Q. Okay. 18 A. I'm not aware that I have them. 19 Q. Fair enough. But you said you'd look, 20 and I won't beat that -- 21 A. I will. 22 Q. All right. You never practiced law in 23 the state of Ohio; is that true? 24 MR. MISHKIND: Objection, asked and 25 answered. 0017 1 Q. Did I ask that already? All right. 2 Prior to your involvement with 3 plaintiffs' counsel in this case, had you made any 4 study of Ohio law on the issue of informed consent? 5 A. I don't know. There was a time when I 6 reviewed cases for Ohio -- other Ohio law firms. 7 That time is fairly remote, but I reviewed quite a 8 number of cases. And I can't say whether or not 9 they involved issues of informed consent or not. I 10 don't remember, but it's possible that they did. 11 Q. And as we sit here today, would it be 12 fair to say, because you don't remember, you are 13 utilizing, as a part of your expert opinion in this 14 case, sort of an inherent knowledge of Ohio law? 15 Fair statement? 16 A. I don't know what you mean by "an 17 inherent knowledge." 18 Q. It's not like you had a body of existing 19 knowledge about Ohio law that you were relying on. 20 A. Well, again, I'm not sure what you're 21 asking. I have seen some Ohio statutes, I believe. 22 And I did in the past, too, in relation to other 23 cases. But I don't know that I'm relying on them in 24 this case. I suppose I would answer your question, 25 no, I'm not relying on them. But I'm not entirely 0018 1 sure I understand the question. 2 Q. That's okay. And your answer clarified, 3 I think, where you're coming from. So as I 4 understand it from reviewing your reports, which I 5 don't know if you received them yet or not. And I 6 don't mean this to be a memory game, so stop me if 7 you need to look at them. But we're getting to the 8 point where we need to start talking about it. 9 There was no specific Ohio statute or Ohio case law 10 referenced in either of your two reports; is that 11 true? 12 A. I don't believe that I referenced any 13 specific Ohio cases or statutes; I believe that 14 that's true. 15 Q. Okay. And based upon that, it's my 16 understanding that you did not make any particular 17 search of Ohio law or statutes regarding informed 18 consent; is that true? 19 A. I know that I've seen some Ohio statute 20 related to this. I don't recall how I accessed that 21 or when I accessed it. I believe that I have seen 22 something, but I didn't -- I don't believe I 23 referenced it in my reports. 24 Q. Is that because you didn't look at it 25 prior to writing your first report? 0019 1 A. I don't recall. I don't know. I'm not 2 sure. 3 Q. The way I read your report, it looked to 4 me like you were trying to give basically, as best 5 as possible, a listing of everything that you relied 6 upon in reaching your opinion. Is that what you 7 were trying to do? 8 A. I don't -- I think so, but again, I don't 9 recall specifically. 10 (Discussion off the record) 11 THE WITNESS: I'm just looking at the 12 reports, and I don't see any reference to Ohio law 13 in the reports. Let me see. The first one, there 14 is not. I believe that's correct, I don't see any 15 reference to Ohio law in either report. 16 BY MR. HERBERT: 17 Q. You would not be holding yourself out as 18 an expert in Ohio law; is that much true? 19 A. I don't think that's, again, why I'm here 20 today. 21 Q. So that's correct -- 22 A. I believe so. I believe so. 23 Q. All right. I'm looking at Defendant's 24 Exhibit A, which is a letter from you to 25 Mr. Kulwicki, dated July 22, 2010. Do you have that 0020 1 in front of you? 2 A. I do. 3 Q. And it lists nine things that you 4 reviewed, at least in preparation for this 5 particular report. Do you see those on the first 6 page? 7 A. Yes. 8 Q. And as it relates to Item No. 8, we have 9 something here -- Actually, let me start with No. 7. 10 We have Item No. 7, CCF policies and procedures 11 regarding informed consent and innovative practices. 12 Is that what we have marked as -- let me see if I 13 can find it -- Item No. G? 14 A. Let me see. 15 I'm not entirely sure. I think it 16 is. I think it's that document which is entitled 17 Informed Consent Policy and Procedure. But I don't 18 see the reference to innovative practices in this 19 document, which makes me wonder whether it may be a 20 document that I haven't brought. I'm not sure 21 whether I'm referring to this document or not. 22 Q. All right. So what you will do is you'll 23 go back and check your file and provide to the court 24 reporter anything additional that relates to 25 Exhibit G, correct? 0021 1 A. Correct. 2 Q. And then referring back to Exhibit A, 3 your initial report, we have Item No. 8, which is 4 described as an archived CCF web page. My question 5 is, would that be Exhibit H? 6 A. Yeah, I believe it is. But let me just 7 check for you. 8 I think it makes reference -- I know 9 it makes reference to the Patient Care Partnership 10 page, and I believe it may make reference to both of 11 the things that we have collected under Exhibit H. 12 But again, I'm not sure. I'd have to check back. 13 It includes at least the first one and probably both 14 of these documents. That's the best I can say 15 without examining it further. I think that's 16 correct. 17 Q. Again, if there's anything additional, 18 you'll go back to your file and provide it to the 19 court reporter? 20 A. Yes, but I think we're correct on that. 21 Q. Fair enough. And then the last one, Item 22 No. 9 is medical literature, is all it says. 23 A. Right. 24 Q. And what I want to know is if you think 25 that Exhibit E, which are the articles you brought 0022 1 with you today, are the same things at least that 2 you are referring to in Item 9 in Defendant's 3 Exhibit A, your first report? 4 A. I suspect that the answer to that is no. 5 But I can't be sure, because I don't know when I 6 received what. And I've been receiving materials 7 over a period of time. Plus when I refer to medical 8 literature here, there's probably more medical 9 literature that I reviewed, that I didn't receive 10 from anybody but actually sought out myself. And 11 some of that would probably be included in this 12 report, and some of it would not. So I think that's 13 a very difficult question for me to answer. 14 Q. Allow me to attack it in a different way, 15 if I might. If you look at Exhibit E, are there any 16 of those articles which you feel you did not likely 17 have at the time that you wrote your July 22, 2010, 18 report? 19 A. I would like to give you a -- a specific 20 answer on that. I can't be sure. I don't -- I 21 honestly don't recall. Because again, I've been 22 reviewing articles and reviewing materials for an 23 extended period of time. And I can't be sure what I 24 had and what I didn't have when I wrote the report. 25 I don't know. 0023 1 These were all -- they're all 2 articles -- I mean, I've reviewed articles as 3 recently as articles published this year, and 4 they're clearly not referenced in that report. But 5 I don't know when I received what and whether I 6 found -- you know, where the material came from and 7 when I received it. So I -- I can't be sure enough 8 to answer that question. I'm sorry. 9 Q. That's okay. And just so the record is 10 clear, you haven't, as part of your work in this 11 case, maintained a bibliography of articles that you 12 feel are pertinent to the issues in this case? 13 A. I have not, that's correct. 14 Q. And you have not seen such bibliography 15 provided to you by any other source, for example 16 plaintiffs' counsel. 17 A. Absolutely not. 18 Q. Okay. You do reference, in both of your 19 reports, sections of the Code of Federal 20 Regulations. Other than the Code of Federal 21 Regulations, did you review any other similar legal 22 rules or guidelines or statutes of any type, nature, 23 or description? 24 MR. MISHKIND: Objection to the form 25 of the question. 0024 1 But go ahead. 2 A. At this point I don't recall any. I 3 don't think I have any other materials, that I 4 haven't brought, that would fall into those 5 categories. Again, I don't remember everything that 6 I've reviewed over what has been an extended period 7 of time, but nothing immediately comes to mind. 8 Q. When you were contacted in this case, do 9 you know how plaintiffs' counsel decided to contact 10 you, how they got word that you were available to 11 review such a case as this? 12 A. I do not. 13 Q. Had you ever worked with their firm in 14 any connection before? 15 A. No. 16 Q. The prior firm they were involved with, 17 with attorney Becker, how about that firm? 18 A. Well, that was the firm that contacted 19 me. 20 Q. Good point. Okay, so I take it it's 21 still a no. So the firms that you had done work for 22 in Ohio, do you remember those names? 23 A. I do. 24 Q. What were they? 25 A. The firm that I did most of the work 0025 1 for -- I know I've reviewed occasional cases over 2 the years for Ohio firms. There was one firm that I 3 did considerable amount of review for them some 4 years ago. And the name of the attorney who was the 5 senior person in that firm was Hans Scherner, 6 S-c-h-e-r-n-e-r. 7 Q. Any others that you recall? 8 A. No, not that I recall. I know I've 9 reviewed other Ohio cases, but not that I recall the 10 firm name. 11 Q. Fair enough. I want, if we can, to shift 12 gears a little bit and talk about some of the 13 opinions that you offer in your two reports. Can we 14 do that now? 15 A. Sure. 16 Q. All right. If you look at the report, I 17 guess I've marked it as Exhibit A, the first report 18 you wrote in this case. You've got about four, five 19 pages in a summary of sort of numbered paragraphs. 20 Do you have those available to you? 21 A. Yes. 22 Q. I'm going to ask you a couple of things 23 about this and kind of go down the list, okay? 24 A. Correct. 25 Q. All right. So as I understand No. 1, 0026 1 you're relying for your -- for your authority, 2 you're relying on federal law; is that correct? 3 A. That's what I'm saying here, yes. It's 4 required by federal law, yes. 5 Q. And just so I'm clear, the federal law 6 you're referring to is the specific CFR sections 7 that are cited in your report? 8 A. Correct. 9 Q. Okay. And if I understand sort of what 10 you set forth in your report, the requirement, as 11 you see it, under federal law relates to research; 12 is that true? 13 A. Well, I believe there's a requirement 14 under federal law for an informed consent and a 15 signed consent, a written consent under Medicare and 16 Medicaid, for Medicare and Medicaid, and that also 17 for research and experimental endeavor, yes. 18 Q. So you would break it down. You would 19 say that there is an issue, as it relates to 20 Medicare and Medicaid, that written consent forms 21 are necessary for what? 22 A. Well, I believe in this case, for 23 example, they would -- They would pertain in this 24 case because I believe that Cleveland Clinic 25 receives Medicare and Medicaid moneys. 0027 1 Q. That's a slightly different question. 2 MR. MISHKIND: Counsel, wait. He's 3 still answering your question. Please let him 4 finish. 5 Q. I think we're off track. You can correct 6 me if I'm wrong. 7 MR. MISHKIND: I just don't want you 8 to cut him off. 9 MR. HERBERT: I don't think I'm doing 10 that. 11 MR. MISHKIND: You did, and the 12 record will reflect that you cut him off. 13 MR. HERBERT: That's your opinion. 14 At any rate -- 15 MR. MISHKIND: The record will 16 reflect whether you did or didn't. 17 BY MR. HERBERT: 18 Q. Let me see if I can do it a different 19 way. As relates to the issue of Medicare and 20 Medicaid, do they specifically require informed 21 consent for anything a physician does, or are there 22 specific categories of things that require an 23 informed consent? 24 MR. MISHKIND: Objection. 25 Go ahead. 0028 1 A. Well, they require an informed consent 2 for surgical procedures. And a procedure such as 3 the procedure that Mr. Sullivan had would fall under 4 the requirement for an informed consent. 5 Q. And specifically, beyond surgical 6 procedures, what else is covered? 7 A. I'm not sure I know what you're asking. 8 I mean, I think it refers -- Again, we've talked 9 about research and experimentation and those sorts 10 of procedures. I don't know what else you're asking 11 me. 12 Q. Let me try with a better question. We're 13 specifically honing in now on Medicare and Medicaid 14 issues. And you've told me that they -- Medicare 15 and Medicaid -- require for surgical procedures a 16 written informed consent. And my follow-up question 17 is: Other than surgical procedures, what other 18 things require a written consent form, under 19 Medicare and Medicaid regulations? 20 A. I'm not sure I know exhaustively what 21 falls under the statute. I mean, I'd have to look 22 back and see. I'm not sure I can tell you that 23 today. 24 Q. All right. That wasn't a particular 25 issue of study, even for your work in this case, 0029 1 true? 2 A. I think so. I think that's correct. 3 Q. Did somebody direct your attention to the 4 fact that there's a Medicare and Medicaid regulation 5 regarding surgical procedures? 6 A. I knew that there was a Medicare and 7 Medicaid regulation that involved the requirement 8 for consent. I don't know that I knew specifically 9 what it said without looking at it, and so I looked 10 at it. But I knew it existed; I had run into it 11 before. 12 Q. Did counsel for plaintiffs or did their 13 office give you the CFR citation or send you a copy 14 of the CFR? 15 A. I believe that they did, but I was aware 16 of its existence before they did that. 17 Q. And you didn't make any particular study 18 of the entire title that covers the subject, did 19 you? 20 A. I did not. I did not. 21 Q. I'm sorry, we missed your answer because 22 of the -- 23 A. I did not. 24 Q. Thank you. As it relates to surgical 25 procedure, is surgical procedure defined under the 0030 1 Code of Federal Regulations as it relates to this 2 specific Medicare and Medicaid regulation we've been 3 talking about? 4 A. I don't think that it's clearly defined 5 under -- you know, or specifically defined, no. 6 Q. Okay. Let's kind of go towards sort of 7 the other leg of your opinion as it relates to the 8 issue of research. Do you follow me? I'm kind of 9 changing gears on you now. 10 A. I do, yeah. 11 Q. Okay. As I understand it, you're relying 12 on this particular section of the Code of Federal 13 Regulations as it relates to research in stating 14 that, in your opinion, the code requires that in 15 this particular case, a written form was necessary; 16 is that much true? 17 A. Well, I don't think it's the only thing 18 that I'm relying on, however. 19 Q. Okay. In addition to the Code of Federal 20 Regulations, are you relying on anything else? 21 A. Well, I believe I'm relying on 22 documentation from Cleveland Clinic itself. I mean, 23 I believe that Cleveland Clinic had policies that 24 we've talked about, which itself required written 25 informed consent for research and experimentation. 0031 1 So I'm relying on those policies, also. 2 Q. Got you. And other than that, anything 3 else? 4 A. I guess I'm -- I believe that that is 5 just a tenet of practice, of informed consent, that 6 anything that falls -- I mean, beyond Cleveland 7 Clinic policies, beyond Medicare and Medicaid 8 regulations, beyond the CFR, it's just the way it's 9 done. I mean, you must have written informed 10 consent for anything that falls under the rubric of 11 experiment or research. That's common practice, 12 universal common practice. 13 Q. And let me start to ask you some specific 14 questions now about this particular issue, if I can. 15 First of all, as it relates to the CFR, just the 16 CFR, not the general tenet or The Cleveland Clinic 17 guideline. Does the CFR specifically define what it 18 means by "research"? 19 A. I don't believe it specifically defines 20 anything of that nature. 21 Q. Okay. As it relates to The Cleveland 22 Clinic protocol that we've talked about, is there a 23 specific definition of "research" there? 24 A. I'd have to look back at the protocol, 25 but I -- I don't think there's any question, I don't 0032 1 think it's possible to question that this procedure, 2 whether or not it fell under research and 3 experimentation. I think there are so many aspects 4 of it that, regardless of specific definition, it's 5 incontrovertible, in my view, that this procedure 6 falls under research and experimentation. 7 Q. In your view, is there a difference 8 between innovation and research? 9 A. "Innovation" is a general, very broad 10 term. Is there a difference? I'm sure there are 11 nuances and differences in definition, but I don't 12 think they're directly related. Research is done 13 with the intent of examining the effectiveness of a 14 procedure and seeing what the outcomes are. And 15 innovation simply means something new, working on 16 something new and different. They may overlap, but 17 we're sort of in semantics here more than anything 18 else. 19 Q. Is there a difference or do you have a 20 definition for "incidental research"? 21 A. I don't know what you mean by "incidental 22 research." 23 Q. Okay. 24 A. I certainly don't think it applies here. 25 This wasn't incidental research. This was research. 0033 1 Q. I mean, obviously, you have some 2 something in mind when you say, you know, this is 3 not incidental research. So in your mind, what 4 would be an example of incidental research, as 5 opposed to what you say happened here? 6 A. Again, I'm not sure what you mean by 7 "incidental research." If there's a purpose of 8 research, then it becomes research. There may be 9 other -- I mean, it may be therapeutic and research 10 at the same time, but that doesn't mean it isn't 11 research. You're looking to remedy a medical 12 situation, to effect either a cure or at least an 13 amelioration of a problem. But just because there's 14 a component of therapy, treatment, doesn't mean that 15 it's not research, too. I'm not sure, again, by 16 "incidental," I don't find that a useful concept. 17 I'm sorry. 18 Q. And I don't mean to beat a dead horse, 19 but I do have to ask this question: Is that 20 particular term utilized, to your knowledge, in the 21 Code of Federal Regulations at all? 22 A. Incidental research? 23 Q. Right. 24 A. I don't -- I don't recall. I don't know. 25 I'd have to look and see. 0034 1 Q. Okay. Now, I have to ask this next 2 question, just to understand your logic. So I'm not 3 trying to be difficult. If you don't follow me, 4 stop me, and I'll try and do it a different way. 5 But I want you to imagine the scenario where, let's 6 say, from 1990 to 2000, any given hospital, and that 7 hospital treats them for the -- 8 A. I'm sorry, your sound is breaking up. 9 There's some problem. Your picture is breaking up, 10 too. 11 Q. All right. I'll try it again. And stop 12 me if it doesn't come through clearly. 13 A. Okay. Now you're clear. 14 Q. Here's the scenario: You've got a 15 situation where a group of patients go to a hospital 16 for a ten- year period of time for the same problem, 17 and they're all treated by that hospital. 18 Retrospectively, somebody decides to do research by 19 pulling old medical records and looking at outcomes. 20 Does the fact that those patients, long after 21 they're gone from the hospital, were involved in a 22 retrospective review mean that their treatment was 23 experimental? 24 MR. MISHKIND: I'm going to object to 25 the hypothetical as stated. But he can certainly 0035 1 answer the question. 2 A. I think it's -- I don't think that one 3 can actually answer a general question like that. I 4 think you have to look at the specific procedure; I 5 think you have to look at the specific facts of the 6 situation, and decide whether it would be research 7 or not research. I don't think there's a good 8 answer to a general question like that. 9 Q. And just so I'm clear, you would not be 10 able to answer whether a retrospective, historical 11 review of medical records would be considered to be 12 research on the patients who were treated at the 13 time of the original treatment. 14 A. Well, I mean, a purely retrospective 15 review simply to collect data to determine outcomes 16 could be viewed as research. But in and of itself, 17 it's not very good research. I mean, retrospective 18 reviews, for good reason, are disfavored 19 comparatively in terms of research. 20 I don't know that I'm answering your 21 question at all, because I don't think I really 22 entirely understand it. I mean, is retrospective 23 review a component of a research approach? 24 Possibly. In certain situations, it might be; and 25 certain situations, it might not be. I might not be 0036 1 understanding you. 2 Q. No, you're getting close. So the only 3 thing I would add to that would be, you would agree 4 with me that the fact that somebody does a 5 retrospective review of charts does not, by virtue 6 of that fact, render the patient's care ten years 7 earlier experimental? 8 MR. MISHKIND: Objection. 9 A. I think by virtue of that fact, just by 10 itself, I think I would probably agree with you. 11 But I don't see how that's pertinent to this 12 situation at all. 13 (Discussion off the record) 14 BY MR. HERBERT: 15 Q. Now, looking at Item No. 2 on your 16 initial report, just so historically, I want to make 17 sure we're on the same page. When you use the 18 phrase "informed consent process" in Item No. 2 19 here, I guess that's what I have a problem with. 20 And let me just state it for you. 21 It's my understanding, from a review 22 of the case and the materials, that Mr. Sullivan, 23 before he came to the clinic, did receive 24 information from various sources about: number one, 25 his problem; number two, the alternatives of 0037 1 treatment for that problem; and number three, the 2 availability of treatment at the Cleveland Clinic, 3 which I believe his own physician described to him 4 as being somewhat experimental. Were you aware of 5 that? 6 MR. MISHKIND: Objection. 7 But go ahead, Doctor. 8 A. Was I aware that Dr. Hong described it 9 as -- Dr. Makino described it as experimental? I 10 forget which it was. I believe it was Dr. Hong. 11 Was I aware that he described it as experimental? 12 Q. Yes, before you wrote your initial 13 report. 14 A. I was aware that he described it as 15 experimental, yes. 16 Q. Okay. So as it relates to the 17 information-gathering process, that actually started 18 before the patient got to The Cleveland Clinic, 19 right? 20 MR. MISHKIND: Objection. 21 A. I'm not sure what you mean by "the 22 information-gathering process," and I'm not sure how 23 it relates to the concept of informed consent. 24 Perhaps you could be more specific. 25 Q. Well, obviously, Mr. Sullivan was told 0038 1 that he had a problem, right? 2 A. Mr. Sullivan was aware that he had a 3 problem, I would agree with that. 4 Q. And he got that information from his 5 treating doctors, right? 6 A. The fact that he had persistent atrial 7 fibrillation, is that what you're referring to? 8 Q. Yes. 9 A. Yes, he got that information from his 10 doctor, correct. 11 Q. And from your review of the materials, 12 there was some discussion that took place between he 13 and his treating doctor, correct? 14 A. There was apparently some discussion, but 15 it's also apparent that his treating doctors didn't 16 know what procedure he was going to have. He was 17 interested in a procedure. There was some 18 discussion about maze procedures and the possibility 19 of a maze procedure. There was some discussion 20 about the fact that perhaps something could be done 21 there in Hawaii, but then some other procedures 22 could not be done in Hawaii. So there was 23 conversation and discussion about it, correct. 24 Q. So at a minimum, the process of 25 investigating the available alternatives began in 0039 1 Hawaii, true? 2 MR. MISHKIND: Objection. 3 Go ahead, Doctor. 4 A. I think that's correct. But again, I 5 don't know that it relates to informed consent. I 6 mean, I agree with you there was discussion, but I 7 wouldn't relate that, in my mind, particularly to 8 informed consent. 9 Q. And in addition to the conversation he 10 had with his cardiologist, he did some independent 11 review and looking things up on his own. Is that 12 your understanding as well? 13 A. Yes, that is my understanding. 14 Q. Okay. And before he came to Cleveland, 15 there were communications between himself and The 16 Cleveland Clinic? 17 A. There was at least a communication 18 between him and Stacy Poe, I believe. 19 Q. Obviously, those things are documented in 20 the depositions, correct? 21 A. They're documented to the extent that 22 they can be documented, yes. 23 Q. Right. And you also, I take it, reviewed 24 the depositions of Mr. and Mrs. Sullivan, true? 25 A. I did. 0040 1 Q. And you would agree with me that they did 2 undertake some investigation of the available 3 alternatives for Mr. Sullivan's problem before they 4 were in contact with The Cleveland Clinic. 5 A. Yes, I would agree with that statement. 6 Q. Okay. So as it relates to the informed 7 consent process, when you use that term in Paragraph 8 No. 2, just so we're both on the same page, are you 9 excluding everything that took place in Hawaii? 10 A. Well, first of all, I don't think you've 11 told me anything about what took place that really 12 fits within the informed consent process. Seeking 13 information on the part of the patient has nothing 14 to do with informed consent. Informed consent has 15 to do with what the patient is told by whoever is 16 going to do the procedure. So we haven't touched on 17 informed consent. So again, I'm not -- I'm not 18 relating what you're asking me to informed consent. 19 There's a process taking place, but it's not 20 informed consent. 21 Q. So do I understand that when you refer to 22 the process, you are intentionally excluding 23 everything that took place in Hawaii -- 24 A. Intentionally? I don't know what you 25 mean. 0041 1 Q. Let me finish my question. 2 -- because in your mind, that's not 3 part of the quote/unquote process? 4 MR. MISHKIND: Object to the form of 5 the question. 6 Go ahead, Doctor. 7 A. You know, I don't know that I agree with 8 "intentionally." I mean, if you want to ask me 9 something that has to do with informed consent, I'll 10 be happy to try to answer it. But it's not 11 intentional. You're not within the definition of 12 informed consent. Seeking information on one's own, 13 it has nothing, in my mind, to do with informed 14 consent. It's seeking information. 15 Q. And in your mind, informed consent has 16 nothing to do with information, as long as that 17 information is not provided directly by the 18 physician doing the procedure? 19 A. Well, to the extent that the patient -- I 20 mean, I think what you're saying is that the patient 21 is attempting to inform himself. That's not 22 informed consent, the patient trying to inform 23 himself. 24 Q. Based on what? 25 A. Based on my understanding and I believe 0042 1 the common understanding of informed consent. 2 Q. It's not based on law -- 3 A. He's not consenting to himself. He's not 4 consenting -- He's seeking information. It's not 5 the same thing. 6 Q. So your opinion in that regard is not 7 based on Ohio law or the Code of Federal 8 Regulations, true? 9 MR. MISHKIND: Objection. 10 Go ahead, Doctor. 11 A. I don't understand your statement. 12 Q. What you just said to me, that the 13 patient seeking information is not part of informed 14 consent, is based upon your personal opinion; it is 15 not based upon Ohio law or the Code of Federal 16 Regulations, correct? 17 MR. MISHKIND: Objection. 18 A. Informed consent is what the patient is 19 told, the information that the patient is given by 20 whoever is going to be doing the procedure, by the 21 provider, by the physician, by the caretaker. 22 Q. And that statement you just made is not 23 based upon a specific Ohio case or statute, true? 24 MR. MISHKIND: Objection. 25 A. Well, I don't know that that's material. 0043 1 It's based on my experience as -- 2 Q. That's okay. 3 MR. MISHKIND: You don't need to 4 interrupt him. 5 Go ahead, Doctor. 6 Q. That's okay. The question remains, 7 you're not relying on specific Ohio case or statute 8 for that opinion -- 9 A. Your sound broke up. I don't understand 10 what you said. 11 Q. That's okay. There's no specific Ohio 12 case or statute that you're relying on. 13 MR. MISHKIND: Objection. 14 Doctor, you can finish your last 15 answer, if you want to. He's moved on to another 16 question. I want the record to be clear and give 17 you an opportunity to finish answering. I've just 18 objected to his most recent question. 19 A. I've lost track of what question we're 20 answering. I mean, I'm now thoroughly 21 discombobulated. 22 Q. I'll give you a minute to get your 23 breath. 24 A. Well, no. Try your question again, and 25 I'll try to answer it again. 0044 1 Q. So there's no specific Ohio case or 2 statute that you're relying on in this case. 3 A. To the extent that I understand what 4 you're asking me, I suppose the answer to that 5 question is no. But again, I'm not sure I 6 understand what you're asking me. 7 Q. I think it will become clear to you as we 8 go along. 9 A. Okay. 10 Q. In this particular case, as we go 11 through -- Let me go down to the next paragraph. 12 Item No. 3, is that based upon the deposition 13 testimony of the Sullivans? 14 A. I believe that it is largely based on the 15 deposition testimony of the Sullivans, that's 16 correct. 17 Q. All right. And just so I'm clear, it's 18 not as if there was a deposition of one of the 19 Cleveland Clinic folks that you're relying on or a 20 website statement that you're relying on for Item 21 No. 3. 22 A. Well, I think it is related to the 23 website statement. I don't think it's related to 24 anything in the deposition material -- Let me be 25 sure, before I say that. 0045 1 Q. Take your time. 2 A. I think that there are elements of that 3 statement that were confirmed in some of the 4 deposition material. For example, that the ablation 5 procedure was an in-and-out procedure. I believe 6 that it was confirmed to the Sullivans that the 7 intent was that he was going to be able to come out 8 right -- you know, the next day or right after the 9 procedure. So that in a sense, I think that was 10 confirmed. 11 That it was safe and proven, I don't 12 recall anything in the other depositions where they 13 clearly said, "Well, we told him it was absolutely 14 safe and proven." That it was very quick, I 15 don't -- I don't recall specifically. But some of 16 that information, I know, is based on the website. 17 The statement that it was safe and proven was based 18 on the website. And there were figures, statistics 19 on the website that I think were very misleading, 20 which aren't directly referred to here. 21 Q. Okay. Anything else about Item 3? 22 A. Not right at this point, that I see. We 23 may come back to it later, but not right at this 24 point. 25 Q. Fair enough. And just so I'm clear, 0046 1 before we move on from Item No. 3, at the bottom you 2 say, in reference to the things we've talked about, 3 that it diluted the discussion of risks. And what I 4 want to ask you is this: Do I understand, from 5 reading that, that you knowledge that there was a 6 discussion of risks? 7 A. I think that, if I recall the Sullivan 8 depositions, that I think there was some discussion 9 of risk. I don't believe they said there was 10 absolutely no discussion of risk, and I think there 11 were some questions asked. But I don't think there 12 was anything that suggested that there was any kind 13 of complete discussion of risk or information that 14 would have covered what needed to be covered in the 15 situation. 16 Q. Item No. 4, take a minute and look at it. 17 And I want to kind of understand what you mean by 18 the phrase "were confusing, contradictory and 19 ostensibly false." Starting with "false." So let 20 me know when you're ready. 21 A. Well, the understanding -- And I think 22 some of this came from the website, and it's not 23 clear what came from discussion. But the indication 24 of the statistical likelihood that this was going to 25 be a successful procedure, I mean, there's no -- no 0047 1 understanding on the part of the Sullivans, because 2 it was not communicated to them what the likelihood 3 of success was here; that there was a difference in 4 results between paroxysmal fibrillation and 5 persistent fibrillation. 6 Stacy Poe, who I think was primarily 7 responsible or was certainly one of the people 8 primarily responsible under the structure to 9 enlighten the Sullivans, doesn't appear to have been 10 aware that there was a difference in the statistical 11 results between paroxysmal and persistent 12 fibrillation. 13 Certainly, the -- what the Sullivans 14 recall and their sense of the information that was 15 conveyed to them by Dr. Burkhardt was, at best, 16 brief; could not have been all inclusive in terms of 17 what they needed to be told; did not approach the 18 procedure as if it was research or experimental, 19 which needed to be done. And that then opened a 20 great deal of information that needed to be provided 21 to the Sullivans, that was not provided to them. 22 We discover that Dr. Burkhardt was 23 aware of the fact that the INR was suboptimal the 24 day before the procedure was done, but they were 25 given no information about that. They were given no 0048 1 information about the fact that there were actually 2 going to be two procedures, in a sense, that were 3 separate; and that the left atrial procedure and the 4 right atrial procedure were going to be done by 5 different mechanisms. 6 They were not told who was going to 7 be doing what procedure. They were not told who was 8 going to be in the operating room when the 9 procedures were done. For example, they appear not 10 to have been informed about who Dr. Kanj was and 11 what his status was. They were not told that there 12 was going to be a company representative in the -- 13 at the procedure. I believe Dr. Burkhardt recalls 14 and confirms that in his -- it is his belief that 15 there was, in fact, a company representative there. 16 There are all kinds of things that 17 were not included or were misleading or false. I 18 don't have any trouble with the term "false." So I 19 think there's lots of information that's not there, 20 that should have been provided to them. 21 Q. Are you ready? 22 A. I guess so. I've probably left some 23 stuff out, but we'll get to it. 24 Q. I'm happy for you to continue if 25 there's -- 0049 1 A. Well, not at the moment. You can ask me 2 a question. 3 Q. Sorry, just let me continue. I just want 4 to make sure that if there's anything else you feel 5 was, you know, contradictory or ostensibly false 6 that you haven't mentioned, let me know. 7 A. All right. We've covered how it would be 8 done. They were really not told how it would be 9 done. They were not even told about the -- the use 10 of the Navistar ThermoCool. They weren't told -- 11 Yeah, we left out something there, because the 12 procedure itself was not FDA approved. The 13 instrument that was used was not FDA approved. They 14 weren't told that. They weren't told that this was 15 actually research, so there's something else. 16 Let's see. Risks and benefits. At 17 best, they had misleading information about the 18 risks and benefits. They certainly weren't given a 19 complete rundown on the risks. There apparently was 20 some discussion about stroke that took place, but I 21 think because that was what Mr. Sullivan 22 particularly was most concerned about. 23 I thought it was striking that Stacy 24 Poe actually didn't remember the Sullivans in 25 particular, except for the fact that he was, I think 0050 1 she said, one of two patients who had seemed very 2 concerned about the possibility of stroke and had 3 asked specifically about it. I'm not sure what he 4 was told, but he was certainly concerned about it. 5 The statistical information that, 6 whatever he was given, certainly wasn't parsed out 7 the way it needed to be. And the website was 8 misleading. 9 So I think that probably a lot of 10 that falls into confusing, contradictory and 11 ostensibly false. I mean, there is such a plethora 12 of stuff that falls under that that I'm not entirely 13 sure we've covered it all. But I'm willing to stop 14 now and move on, if you want to. 15 Q. Here's the point of the deposition and, 16 maybe you didn't understand at the time, the point 17 of writing these reports as well: That we would 18 have an idea of what your opinions were and the 19 basis of those opinions. So you say you've got some 20 issues with things that were said; they were 21 confusing, contradictory and ostensibly false. And 22 my point here today is to understand from you what 23 those things are. And you've endeavored to give me 24 an understanding of what those things are. But I'm 25 entitled to know, before trial, if there's anything 0051 1 else. 2 So what I would do at this point is 3 say to you, if there's anything else, let me know. 4 You know, you'll have an opportunity to review the 5 transcript after it's written up. If you want to 6 add things, let me know. But don't wait until the 7 day before trial or the day you show up at trial to 8 add a bunch of new stuff, because that would be a 9 surprise. 10 A. I promise you, I won't do that. 11 Q. All right. Are you satisfied that you've 12 at least touched on all the areas that you want to 13 discuss as it relates to Item No. 4? And probably 14 number 5, as we look at it. And 6, 7. 15 A. Let me read these. 16 Q. Go ahead. I'll go through it at the same 17 time. 18 A. Okay. I think we've covered Item No. 5; 19 I think I've discussed that. I want to reiterate 20 the issue about the suboptimal INR and the fact that 21 they were not -- they were not informed -- Well, I 22 don't believe they were informed about the 23 suboptimal INR. I'm not sure, but I don't think 24 they were. What they weren't informed, even if they 25 were informed about the suboptimal INR, about the 0052 1 considerable risk that that placed Mr. Sullivan at 2 of stroke. 3 Certainly, Item No. 6 we've already 4 touched on. But they were not aware that this had 5 not been established as being safe and effective for 6 use by the FDA. No. 7, I do not believe that they 7 were told that Dr. Kanj was a fellow. They 8 certainly weren't told about a nonphysician, device 9 representative being there. 10 They certainly weren't given an 11 exhaustive list of the potential complications. And 12 I think, you know, we can see the list that was 13 suggested under The Cleveland Clinic research paper 14 on the use of the Navistar, and in general talking 15 about ablation itself. There are long paragraphs of 16 information that -- that The Cleveland Clinic itself 17 felt should be communicated to somebody if they were 18 involved in research or experimentation. That was 19 not conveyed to the Sullivans. 20 I'm down to No. 7. I think we've 21 finished. Do you want to go past No. 7? 22 Q. Yeah, keep going. 23 A. All right. Let me read 8, 9, and 10. 24 We've discussed 8. We touched on 9 25 and their specific figures. We didn't talk about 0053 1 the transesophageal echocardiogram, which really 2 needed to be done before this procedure was done, 3 primarily I think because of the suboptimal INR 4 which put him at greater risk, and because it's the 5 best procedure. I think he had a transthoracic 6 study done, but not a transesophageal 7 echocardiogram. 8 And they weren't told that that 9 was -- I think it's referred to in one of the papers 10 as the gold standard, the transesophageal 11 echocardiogram. But it was particularly important 12 here because they were about to do the procedure 13 with the suboptimal INR. And he also had some 14 enlargement of the left atrium. So when you add all 15 of that together, he really should have had the 16 transesophageal echocardiogram. They weren't told 17 anything about any of this. 18 Q. Are you done? 19 A. I think so. But you may stimulate more 20 thoughts, if you ask me more questions. But for the 21 moment, I think I'm done, yes. 22 Q. I shall try. The information about 23 suboptimal INR, where did you obtain that from? 24 A. Oh, gosh. Lots of places. I mean, 25 articles that I received from counsel, material I 0054 1 read myself and sought out myself in the literature. 2 It's really -- That information is pretty pervasive 3 in all of the literature relating to fibrillation 4 and ablation procedures. 5 Q. As it relates to doing this type of 6 procedure, that's not an area of your medical 7 expertise, true? 8 A. It's out there in the literature for 9 anybody to read. Any physician can access that 10 information. It's common information. There are 11 articles galore. I actually had awareness of it 12 before this case. 13 Q. You were a pediatrician? 14 A. Yes. But I've reviewed many cases that 15 involved issues like this, and I've reviewed other 16 ablation cases in the past. I have a case that I'm 17 reviewing now, that I've reviewed this week or this 18 past week, involving a question of ablation in a 19 child, whether a child, age nine, should or should 20 not have an ablation procedure. 21 I mean, I'm in the literature all the 22 time, reviewing medical literature for literally 23 hundreds of cases that I've reviewed over the years. 24 So you come across the same kinds of issues again 25 and again and again. It's not just this case. 0055 1 Q. Just so I understand what you're saying, 2 your expertise does not come from your education, 3 training and experience in doing these procedures. 4 You have reviewed medical literature written by 5 other people who do do this procedure. 6 A. I have reviewed cases involving these 7 questions. I have reviewed tons of literature over 8 the years. I've reviewed hundreds, probably at this 9 point thousands, of cases involving adult medicine 10 and raising these very kinds of questions. So, I 11 mean, it's not based on my experience as a 12 practicing pediatrician, although I have a lot of 13 experience as a pediatrician. But I think this 14 information is gleaned from lots of different 15 sources. And it's not hard to find this 16 information. 17 Q. Just so we don't get too far afield, 18 these thousands of cases you've been involved in 19 that you talk about reviewing, what percentage of 20 those has your role been as a plaintiff's counsel or 21 consultant for a plaintiff's firm? 22 MR. MISHKIND: Objection, asked and 23 answered. 24 Go ahead, Doctor. 25 A. Yeah, I think we've already talked about 0056 1 that. It's got to be above 90 percent but it's 2 probably not 99 percent. It's probably between -- I 3 would say probably 95 percent or 96 percent. 4 Q. So that relates specifically also to the 5 atrial fibrillation cases that you've talked about 6 reviewing, right? 7 A. It doesn't change medicine. The medicine 8 is the medicine; the information is the information. 9 The articles that I read are the same articles that 10 defense experts and defense counsel read. The 11 information is all out there, and it's pretty 12 incontrovertible. It doesn't change because you're 13 reviewing it for a plaintiff's case or for a defense 14 case. It's out there for everybody. 15 Q. You've never written any of these 16 articles that deal with any of the issues pertinent 17 to this case, true? 18 A. I have not written any articles pertinent 19 to this case, true. 20 Q. Because your education, training and 21 experience would not allow you to publish such 22 articles in a peer-reviewed journal, correct, sir? 23 A. I -- It's not what I do. 24 Q. Right, thank you. As we get to 25 Defendant's Exhibit B, let me direct your attention 0057 1 to the first paragraph. 2 MR. MISHKIND: The report of 3 January -- 4 Q. January 31, 2011. 5 MR. MISHKIND: Thank you. 6 A. Yes. 7 Q. Okay. I guess the paragraph begs the 8 following question: Were you asked to provide a 9 supplemental report? 10 A. I don't recall. I may have been. I 11 don't recall. 12 Q. You mentioned, in your first sentence 13 here, that you had occasion to examine a number of 14 regulations of the Department of Health and Human 15 Services, and were struck by the fact that some of 16 these regulations relating to research appear to 17 pertain to the case we're here talking about. And I 18 guess I have to ask: The occasion to review those 19 regulations, was it because they were sent to you by 20 plaintiffs' counsel? 21 A. I believe that's correct, yes. 22 Q. Okay. It was written in such a way as it 23 almost implies that you were, for some other reason, 24 perusing the Code of Federal Regulations. 25 A. I don't read it recreationally, no. I 0058 1 think they were probably sent to me by plaintiffs' 2 counsel, yes. 3 Q. Okay. Do you think it's likely they 4 asked you to provide an additional opinion that was 5 not set forth in your original report? 6 A. I think -- Yes, I think that it is 7 likely. 8 Q. All right. And you did. 9 A. Looks like it. 10 Q. Now, the specific request that generated 11 Defendant's Exhibit B, was that in writing or was it 12 verbal? 13 A. I don't recall. It may have been either. 14 I don't recall. 15 Q. If you have that writing in your stack of 16 materials, the request for Defendant's Exhibit B 17 from plaintiffs' counsel, I take it you will review 18 your stack of file materials and provide that to the 19 court reporter? 20 A. I will. 21 Q. Likewise, do you have any e-mails on this 22 case? 23 A. No. 24 Q. Were any e-mails sent to you during the 25 pendency of this case? 0059 1 A. I don't remember any. I mean, I can't 2 absolutely say no, but I'm not aware of any. 3 Q. And do you have a computer that you have 4 an e-mail address at? 5 A. I do. I think I've gotten e-mails from 6 Mr. Kulwicki's assistant about timing of the case 7 and when the deposition would take place and stuff 8 like that. I don't know that -- Go ahead. 9 Q. And do you keep a computer file with such 10 communications? 11 A. No. 12 Q. You would be able to check your computer 13 under the e-mail program, under Deleted Items, to 14 see if you had any e-mails, correct? 15 A. If I know how to do that. I don't -- 16 What is it that you're asking me to do? Be more 17 specific. 18 Q. I will do so. Check your computer files 19 in your e-mail program, looking under either the 20 Inbox or the Outbox or the Deleted Files section or 21 all of the above, and print off any e-mails that you 22 have relating to this case, and provide it to the 23 court reporter. 24 A. I will do that. I will tell you that I 25 periodically delete all my deleted files, because 0060 1 they accumulate. So I don't know that there's 2 anything to find, but I will look. 3 Q. And all I can do is ask. Thank you. 4 In Defendant's Exhibit B, the 5 articles that you reference, those were likewise 6 items that were sent to you by plaintiffs' counsel, 7 requesting a specific opinion? 8 A. I believe so, yes. 9 Q. In the various postings that you've had, 10 I understand you've never been or held the position 11 of risk manager or risk management director? 12 MR. MISHKIND: Joe, when you say 13 "postings," what do you mean by "postings"? 14 MR. HERBERT: Whatever jobs he's had 15 in the past. 16 A. Risk management has often reported to me. 17 I have not been the risk management director; the 18 risk management director reported to me. 19 BY MR. HERBERT: 20 Q. So I'm correct, you have not been the 21 risk management director, right? 22 A. Well, you're correct in the sense that 23 that has not been my title, but I have been 24 responsible for overseeing risk management in large 25 hospital systems. 0061 1 Q. And you also have never been the vice 2 president of legal affairs, true? 3 A. Well, if you'll allow me, I'll give you 4 an answer to that question, that is the best I can 5 do for you: When I came to the Inova Health 6 System -- which is a large, multi-hospital health 7 system in Northern Virginia -- I was their first 8 vice president for medical affairs. And the 9 attorneys that were used by the hospital system were 10 outside attorneys, and I felt that that was quite 11 unsatisfactory. And so I took responsibility -- I 12 was given responsibility for overseeing legal 13 affairs. 14 And I hired the first in-house 15 attorney for the system. And then we built an 16 internal department of legal affairs at the system. 17 So while I wasn't the director of legal affairs, I 18 built the department of legal affairs, that 19 ultimately became the department for the system, and 20 worked with those attorneys who were hired during 21 the time that I was there. So I could say to you, 22 no, my title wasn't director of legal affairs; and 23 yet, I was responsible for legal affairs. Let me 24 finish, please. 25 In other positions that I've held 0062 1 where my title was medical director, because I have 2 a law degree, and because I have a great deal of 3 experience in medical-legal issues, and because I 4 taught law school and taught health law, I also had 5 responsibility for legal affairs for the 6 organization, for medical-legal affairs for the 7 organization. 8 So I could answer your question no, 9 that wasn't my title, but that would be misleading 10 in terms of my experience. I'm sorry to give you 11 such a long answer. 12 Q. No problem. As I understand it, there 13 came a time at a number of hospitals you worked at, 14 including Inova, where they did have a vice 15 president of legal affairs; is that true? 16 A. That's true, yes. In the case of Inova, 17 it was the person I hired and worked with and 18 oriented and broke in. 19 Q. And what was that person's background as 20 it relates to risk management or trying cases? 21 A. Well, you know, you're testing my memory. 22 But as I recall, she was relatively young and was 23 out of her training. And I'm trying to recall, she 24 had had a little bit of experience in the health law 25 area before, but not a lot. Trying cases, she 0063 1 wasn't -- she wasn't a litigator. But she was very 2 interested in hospital law and had had courses. She 3 ended up taking over -- She became the director of 4 legal affairs. 5 Q. And what is her name? 6 A. I don't recall. 7 Q. That's okay. 8 A. Cindy -- You forget these things, I'm 9 sorry. 10 Q. That's fine. In looking at the CV that I 11 was provided, one of your areas of interest, it 12 appeared from reviewing the CV, was that you were 13 involved in sort of running or managing or designing 14 HMOs or managed care plans or insurance plans; is 15 that correct? 16 A. Yes. 17 Q. Okay. What percentage of your work at 18 Inova dealt with those types of issues? 19 A. Well, I was the medical director. Vice 20 president of medical affairs was the medical 21 director position; it was the title. Most of my 22 responsibilities there involved the physicians. I 23 was responsible for overseeing quality. The 24 director of quality reported to me. There was no 25 medical director of quality when I came, but I hired 0064 1 a director -- a medical director of quality, who 2 then reported to me. The nurses who were involved 3 in quality reported -- the head, the leading nurses 4 reported to me. 5 So I was responsible for quality of 6 care. I was responsible for overseeing risk 7 management. I was responsible for legal issues. I 8 was responsible for dealing with physician issues. 9 And we had a total of over 2,000 physicians; there 10 were a large number of physicians across the four- 11 hospital system. So I became involved in many 12 contract issues, managed care, because I had worked 13 and actually had been a medical director in managed 14 care. And then I later went back and became a 15 national medical director in the health insurance 16 company. 17 But all of that stuff fell under me 18 because I had all the experience in managed care. 19 So I did a lot of contracting, negotiation, building 20 physician groups to participate in managed care. 21 Because in the '90s, that was a very big issue with 22 hospital. I had a lot of things I covered, a lot of 23 material I was responsible for. 24 I don't know that I can break it down 25 into a percentage. But basically, I was there to 0065 1 deal with medical staff issues and quality issues, 2 quality of care issues. Sort of like the issues in 3 this case, quality of care issues. 4 MR. MISHKIND: Doctor, are you done 5 with your answer? 6 THE WITNESS: I think so. I'm never 7 quite sure when I'm done, but I think I'm done. 8 MR. MISHKIND: The only reason I ask 9 that question -- this is Howard Mishkind speaking, 10 for the record -- I just wanted to take a five- 11 minute break at this time. And I didn't want to 12 interrupt if you were still answering. 13 THE WITNESS: No, I think I'm done. 14 (Recess, 01:48 PM to 01:58 PM) 15 BY MR. HERBERT: 16 Q. To follow up on something I asked 17 already, I think I know the answer to, but I'm 18 asking it just because I want to make sure I'm 19 clear. 20 A. Okay. 21 Q. I had asked you before, you told me that 22 you had retired in 2007 from the position at, I 23 think it was, Inova. 24 A. No, that was Heartland Health Systems. 25 Q. Right. And I asked you what you had been 0066 1 doing since then, and you've told me about the 2 medical-legal consulting that you've been doing. 3 Have you been doing anything else professionally, in 4 terms of earning income? 5 A. No. 6 Q. So you would say that you're retired or 7 semiretired? How would you characterize it? 8 A. I think I'm indolent. No, I guess I'm -- 9 I guess I'm -- I guess I'm semiretired. I like 10 that. 11 Q. Okay. And it's been that way since 2007? 12 A. The end of 2007, when I left the 13 Heartland Health System, that's correct. 14 Q. Okay. What took you to Portland? 15 A. My youngest son. I have four sons. And 16 my youngest son decided that he was going to take a 17 master's degree at Portland State University. And I 18 had already retired from the Heartland System. 19 And my wife, who is the chair of the 20 department of speech at Portland State University, 21 she was the chair of the department in Kansas, where 22 we moved from. But she could obtain a chair 23 anywhere she went, because she's the president-elect 24 of the American Speech and Hearing Association. So 25 we were flexible. 0067 1 And my youngest son said, "Why don't 2 you move to Portland with me?" He was going to take 3 a master's. And I have two sons already in 4 California. So we decided to move to the West 5 Coast. We'd never lived on the West Coast. 6 Q. I don't have any other questions for you. 7 You have the right to review the transcript 8 afterwards, and you've got some homework to do. 9 A. Yes, I do. And I'll check, and I will 10 even check my computer. And I might have something 11 on there. If I do, I will definitely pass it on. 12 MR. HERBERT: Thank you very much. 13 14 (DEPOSITION CONCLUDED AT 02:01 P.M.) 15 16 17 18 19 20 21 22 23 24 25 0068 1 C E R T I F I C A T E 2 I, Deelana Johnson, Registered 3 Professional Reporter and Certified Shorthand Reporter 4 for the State of Oregon, certify that on the 20th day of 5 April, 2011, I reported the Oral Deposition of ROBERT 6 CHABON, M.D., after the witness had first been duly 7 cautioned and sworn to testify under oath; said 8 deposition was subsequently transcribed by me and under 9 my supervision and contains a full, true and complete 10 transcription of the proceedings had at said time and 11 place. 12 I further certify that I am neither 13 counsel for nor related to any party in this cause and 14 am not financially interested in its outcome. 15 GIVEN UNDER MY HAND AND SEAL on this 21st 16 day of April, 2011. 17 18 _____________________________________ 19 DEELANA JOHNSON, RPR, CSR 20 Oregon CSR No. 90-0104 21 22 23 24 25