0001 1 IN THE COURT OF COMMON PLEAS 2 OF CUYAHOGA COUNTY, OHIO 3 ~~~~~~~~~~~~~~~~~~~~ 4 SHANNON SULLIVAN, et al., 5 6 Plaintiffs, 7 8 vs. Case No. CV 09 697617 9 10 THE CLEVELAND CLINIC FOUNDATION, 11 12 Defendant. 13 ~~~~~~~~~~~~~~~~~~~~ 14 Deposition of 15 JOHN PAUL CONOMY, M.D., J.D. 16 March 15, 2011 17 10:12 a.m. 18 19 Taken at: 20 Office of John Paul Conomy, M.D., J.D. 21 27629 Chagrin Boulevard, Suite 205 22 Beachwood, Ohio 23 24 25 Ashanti Edwards, RPR 0002 1 APPEARANCES: 2 3 On behalf of the Plaintiffs: 4 Mishkind Law Firm Co., L.P.A., by 5 HOWARD D. MISHKIND, ESQ. 6 DAVID A. KULWICKI, ESQ. 7 23240 Chagrin Boulevard, Suite 101 8 Commerce Park IV 9 Cleveland, Ohio 44122 10 (216) 241-2600 11 Hmishkind@mishkindlaw.com 12 13 On behalf of the Defendant: 14 Roetzel & Andress Co., L.P.A., by 15 ANNA MOORE CARULAS, ESQ. 16 1375 East Ninth Street 17 One Cleveland Center 18 Cleveland, Ohio 44114 19 (216) 615-7401 20 Acarulas@ralaw.com 21 ~ ~ ~ ~ ~ 22 23 24 25 0003 1 TRANSCRIPT INDEX 2 3 APPEARANCES............................... 2 4 5 INDEX OF EXHIBITS ........................ 4 6 7 EXAMINATION OF JOHN PAUL CONOMY, M.D., J.D. 8 BY MS. CARULAS............................ 5 9 10 REPORTER'S CERTIFICATE.................... 120 11 12 EXHIBIT CUSTODY 13 EXHIBITS RETAINED BY COURT REPORTER 14 15 16 17 18 19 20 21 22 23 24 25 0004 1 INDEX OF EXHIBITS 2 NUMBER DESCRIPTION MARKED 3 Exhibit A Letter from Mr. to Dr. ....... 6 Conomy dated May 28th, 2010 4 Exhibit B Summary Report dated June .... 10 5 21, 2010 6 Exhibit C Code of Federal Regulations, . 20 Title 21 7 Exhibit D Updated CV.................... 29 8 Exhibit E Article by Dr. Kanj........... 103 9 Exhibit F ACC/AHA/ESC Practice ......... 108 10 Guidelines 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 0005 1 JOHN PAUL CONOMY, M.D., J.D., of 2 lawful age, called for examination, as provided 3 by the Ohio Rules of Civil Procedure, being by 4 me first duly sworn, as hereinafter certified, 5 deposed and said as follows: 6 EXAMINATION OF JOHN PAUL CONOMY, M.D., J.D. 7 BY MS. CARULAS: 8 Q. State your full name for the 9 record, please. State your full name for the 10 record, please. 11 A. My name is John Conomy. 12 Q. Dr. Conomy, we've met before. I'm 13 here to take your discovery deposition. You 14 brought -- did you bring your entire file on 15 this case with you? 16 A. I did. 17 Q. Okay. I tried to look through it. 18 I didn't want to disrupt it too much. 19 Can you tell me when it was you 20 were first contacted in this case? 21 A. There should be some transmittal 22 letters. It appears that I was first contacted 23 on May 20th, 2010 -- 24 Q. Okay. 25 A. -- by Mr. Kulwicki. 0006 1 Q. All right. Do you have a letter 2 there? 3 A. Yes. 4 - - - - - 5 (Thereupon, Deposition Exhibit A, 6 Letter from Mr. to Dr. Conomy dated 7 May 28th, 2010, was marked for 8 purposes of identification.) 9 - - - - - 10 Q. We have a letter here May 28th, 11 2010 from Mr. Kulwicki to you enclosing a 12 number of materials. 13 Did you speak with Mr. Kulwicki 14 prior to him sending you this letter? 15 A. I probably did, but I don't have a 16 recollection of it. Such conversations usually 17 come in the middle of something else. He may 18 have said something about the case and I agreed 19 to review it. I'm telling you that because 20 that is what usually happens. I don't have a 21 specific recollection of it. 22 Q. Okay. We're going to need to leave 23 that out because that's going to be attached to 24 the transcript. 25 A. Okay. I can get some copies for 0007 1 you at the end. 2 Q. All right. At any point in time 3 have you spoken with a woman by the name of 4 Michelle Mahon from Mr. Kulwicki's office? 5 A. No. 6 Q. Okay. You've spoken with 7 Mr. Kulwicki about the case, obviously? 8 A. Yes. 9 Q. Prior to today have you ever spoken 10 with Mr. Mishkind about the case? 11 A. No, I have not. 12 Q. Now, you authored a report that's 13 dated June 21st, 2010? 14 A. Yes. 15 Q. Which is a five-page report; is 16 that correct? 17 A. That's correct. 18 Q. Besides this document, have you 19 authored any other reports? 20 A. No, I have not. I received a life 21 care plan, but I -- I think I included -- I may 22 not have. But I know I received that 23 additionally as a separate mailing. 24 Q. Okay. But this is the only -- this 25 June 21st, 2010 is the only report you've 0008 1 authored, correct? 2 A. That's correct. 3 Q. And from my review of your report, 4 we'll go into it in greater detail, but it 5 appears as if your opinions in this case are 6 going to be limited to the issues of causation 7 and damages, correct? 8 A. Yes. With the understanding that 9 causation and damage frequently touches upon 10 other elements, yes. 11 Q. Okay. Fair enough that you will 12 not be rendering any standard of care opinions 13 as to what is the reasonable and appropriate 14 standard of care for an electrophysiologist? 15 A. Not for a cardiac 16 electrophysiologist, no. 17 Q. Okay. And as far as the overall 18 case, by saying you are going to testify on 19 causation and damage, you will not be rendering 20 any standard of care opinions at all, fair? 21 A. Well, there are some things that 22 touch on the issue of research that may butt up 23 against that. 24 Q. Okay. 25 A. I intend to respond to questions on 0009 1 that depending on how they're framed. 2 Q. Okay. In your report of June 21st, 3 2010, did you set forth any standard of care 4 opinions? 5 A. No, I did not. 6 Q. Okay. Am I -- you understand since 7 you've been through a deposition many, many 8 times, am I safe to, as I leave here today, 9 understand that your testimony will be limited 10 to causation and damages and you will not be 11 rendering any, quote, unquote, standard of care 12 opinions, true? 13 A. Yes. You've asked the question 14 several times. If I may, let me have you move 15 to point 7, which is on page 4. 16 Q. Yes. 17 A. He is subjected to cardioversion in 18 the course of his cardiac treatment. That may 19 touch upon administrative matters rather than 20 medical matters that involve physician 21 treatment. Whether those could be interpreted 22 as standard of care opinions or causation 23 opinions I would leave to you. 24 Q. Okay. Well, I -- you have not 25 authored any standard of care -- you expressed 0010 1 no standard of care opinions in your report, 2 correct? 3 A. That's correct. With respect to 4 the physicians and people who cared for him, I 5 have no standard of care opinions. 6 Q. Okay. And you have expressed no 7 standard of care opinions as to specifically 8 the hospital in this report, true? 9 A. Not specifically. 10 Q. All right. So I will question you 11 here today on the issues of causation and 12 damages. 13 Fair? 14 A. Fine. 15 - - - - - 16 (Thereupon, Deposition Exhibit B, 17 Summary Report dated June 21, 2010, 18 was marked for purposes of 19 identification.) 20 - - - - - 21 Q. Okay. Now, in your report you have 22 listed a number of different materials that you 23 reviewed in this case. We'll just mark your 24 report as Exhibit B. Let me just put this at 25 the bottom of that, please. I'll put it right 0011 1 here. First of all, you have the records of 2 the Cleveland Clinic and then secondly -- and 3 you have those in your lap right now? 4 A. I have everything in my lap. 5 Q. You have imaging studies from the 6 Cleveland Clinic. What imaging studies -- 7 A. Brain imaging studies. 8 Q. All right. So those are studies 9 after the stroke in this case? 10 A. Yes, they are. 11 Q. All right. You have not looked at 12 any pre-procedure imaging, true? 13 A. Of what? Of his brain or anything 14 else? I have not seen any pre-imaging -- 15 Q. All right. You have listed here 16 the treatment records of a Dr. Ahu, Crowly, 17 Tanabe, Wong and Makino. 18 A. I have. Tanabe, Wong, Makino, you 19 know, they're all from Honolulu. 20 Q. And it looks like you also at least 21 referenced Ahu and Crowly, correct? 22 A. Yes. 23 Q. Besides these records here, have 24 you been provided and reviewed any other 25 records from outside of the Cleveland Clinic? 0012 1 A. No. 2 Q. Have you asked for any other 3 records outside the Cleveland Clinic? 4 A. Not to this point. 5 Q. You have reviewed the deposition of 6 Dr. Burkhardt? 7 A. I have. 8 Q. I assume you have not reviewed any 9 other depositions in this case? 10 A. Yeah, I have. But I'm not sure -- 11 let me be sure about what it is I'm telling you 12 here. I think that's correct. Just his. 13 Q. Are there any depositions that you 14 have requested that you have not received? 15 A. No, there are not. 16 Q. So in order to come up with your 17 opinions you did not feel that any of the other 18 depositions were necessary, is that fair? 19 A. No. That's not fair. I don't know 20 whose deposition was taken, I don't know what 21 they were asked, if they think important rather 22 than me to call the earth to see who's been 23 deposed and what they've said. I certainly 24 want depositions if they are important. I 25 don't know who's been deposed about what. I 0013 1 would have to leave that to the discernment of 2 Mr. Mishkind and Mr. Kulwicki. 3 Q. Okay. So as a result what you're 4 saying is in a case such as this you wouldn't 5 ask for depositions? You would wait and if 6 they feel they're relevant, then you would 7 review them -- 8 A. Yes. 9 Q. -- and if they didn't feel they 10 were relevant, you don't ask for them? 11 A. Correct. 12 Q. Okay. Now, you then were provided 13 with website material from the Cleveland 14 Clinic? 15 A. Well, I'm not sure where it came 16 from, but it's website materials or offprints 17 of library materials. I'm not sure where it 18 originated. They didn't originate at the 19 Cleveland Clinic. They're part of professional 20 conversations, public domain. 21 Q. All right. And then you have a 22 listing here of what you described as worm 23 sources? 24 A. Yes. 25 Q. You've listed an article by 0014 1 Dr. DiBiase -- 2 A. Yes. 3 Q. -- Dr. Kanj and Dr. Wazni? 4 A. That's correct. 5 Q. As far as those three articles, 6 which you listed there, were those provided to 7 you by Mr. Kulwicki? 8 A. Those were. 9 Q. Okay. And then on the next page it 10 goes -- you also list the American College of 11 Cardiology, American Heart Association 12 Guidelines, the European Society of Cardiology 13 expert consensus statement and an article by 14 lead author Patel; is that correct? 15 A. Yes. 16 Q. Those three items were also 17 provided to you by Mr. Kulwicki? 18 A. They were. 19 Q. Have you, yourself, done any 20 specific research on your own to come up with 21 your opinions in this case? 22 A. Well, the opinions haven't been 23 elicited yet, but I did print off the Code of 24 Federal Regulations, Title 21, and a couple of 25 forms that have to do with the issue of 0015 1 informed consent. Now, I did this because in 2 the material furnished from the Cleveland 3 Clinic, authored by Dr. Luigi DiBiase and 4 others, it is said that the sort of cardiac 5 ablation procedure that Mr. Shannon Sullivan 6 underwent was part of a research study. It was 7 confirmed and managed by the institutional 8 review board and, therefore, I would assume 9 confirming those requirements that govern the 10 experimental testing and research done on 11 humans. 12 Q. Okay. I notice the date of when 13 you pulled this off of the website is today? 14 A. That's exactly right. 15 Q. Okay. 16 A. I'll tell you why. I want to keep 17 it with this case rather than pulling it out 18 from other cases. I think it's bona fide and, 19 you know, tested and in place in clinical 20 research for a very long time preceding today. 21 And I'm familiar with it. 22 Q. Okay. Now, I assume today 23 Mr. Kulwicki and Mr. Mishkind came out to talk 24 to you about this case, correct? 25 A. Yes. 0016 1 Q. And this was pulled off while they 2 were here in the office with you? 3 A. Yes. But they were busy nattering 4 at each other while I did that. I don't know 5 if they had a chance to see it or read it yet. 6 Q. Okay. 7 A. Probably not. 8 Q. However, you pulled this off of the 9 internet during the time period that they were 10 here meeting with you in the office? 11 A. Yes, I did. 12 Q. And so this issue -- I see that 13 there's nothing in your report as far as the 14 Code of Federal Regulations; is that correct? 15 A. Yeah. It's not. 16 Q. Okay. So the first time that that 17 issue came into discussion with Mr. Kulwicki 18 and Mr. Mishkind was today, correct? 19 A. No. That's not correct. 20 Q. When did you speak with either of 21 them about the Code of Federal Regulations 22 before today? 23 A. I can't remember the exact date. I 24 know it was a conversation with Mr. Kulwicki 25 and it was indeterminate as to what to do with 0017 1 that issue. 2 Q. All right. Tell me about that. 3 A. I just did. 4 Q. How was it indeterminate? Tell me 5 about the discussion you had. 6 A. They weren't sure how it might be 7 incorporated or pursued. 8 Q. And when was this discussion? This 9 was Mr. Kulwicki and you? 10 A. I don't remember exactly. It was 11 some time ago. Months. 12 Q. Months ago? 13 A. Um-hmm. 14 Q. And when you say they weren't sure 15 about how this would be incorporated, explain 16 that to me. 17 MR. KULWICKI: Let me object. I'm 18 going to instruct the witness not to answer. 19 To the extent that we had conversations about 20 medical-legal aspects in this case and 21 Dr. Conomy acting as our consultant, that's 22 attorney work product. You certainly can ask 23 him anything about his opinions in his report, 24 but I don't think it's appropriate for you to 25 inquire about conversations that he and I had. 0018 1 I'm going to instruct him not to answer that 2 question. 3 MS. CARULAS: Well, I disagree. 4 There is no privilege that exists between you 5 and an expert witness. Anything that goes into 6 the formation of his opinion, whether it's 7 review of individual documents or discussions 8 with an attorney, is absolute fair game. You 9 know that. 10 MR. KULWICKI: Well -- 11 MS. CARULAS: Let me finish. I'm 12 entitled to know what the discussion was 13 between the two of you, just as I'm entitled to 14 correspondence between the two of you, which 15 you did not object to. We're either going to 16 come back here again at your expense -- we can 17 call the court right now, if you'd like. But 18 let's just move on and -- 19 MR. KULWICKI: The predicate is 20 that he relied on -- your statement was he 21 relied on something that took place in his and 22 my conversation. You haven't established that 23 yet. The extent that we have a discussion and 24 he's advising me about medical-legal 25 implications of different medical issues is 0019 1 different from you getting his opinions on the 2 table and the bases for his opinions. I don't 3 have any problem with you asking about the 4 bases of his opinions, but I don't think you 5 have a right to inquire about our 6 conversations. So I stand by it. 7 MS. CARULAS: Well, I disagree. 8 We'll come back if we need to. 9 MR. KULWICKI: Okay. 10 BY MS. CARULAS: 11 Q. Now, tell me, were you asked at any 12 point in time to author an opinion prior to 13 coming here today on the issue of the Code of 14 Federal Regulations? 15 A. I was not asked to author such an 16 opinion today. 17 Q. Okay. So you do not plan to give 18 any opinions today on the issue of this Code of 19 Federal Regulations and the subject of this, 20 correct? 21 A. Not exactly. Depends on if I'm 22 asked. If I'm asked, I intend to reply. If 23 I'm not, I won't. 24 - - - - - 25 (Thereupon, Deposition Exhibit C, 0020 1 Code of Federal Regulations, Title 2 21, was marked for purposes of 3 identification.) 4 - - - - - 5 Q. Okay. All right. Let me ask you 6 then, just so I'm clear, as far as this Code of 7 Federal Regulations that you pulled up off the 8 computer today while Mr. Mishkind and 9 Mr. Kulwicki were here with you, prior to this, 10 which we've marked as Exhibit C, have you done 11 any other independent research in this case? 12 A. No. Not really. Certainly the 13 kinds of things from the Department of 14 Cardiology at the Cleveland Clinic about 15 innovative techniques and so forth were highly 16 instructive, but I did not do independent 17 research beyond that. 18 Q. Okay. Other than these two 19 gentlemen, have you spoken with anyone else 20 about this case? 21 A. No, I have not. 22 Q. I assume you have not met 23 Mr. Sullivan? 24 A. I hope to. I'm going to give a 25 couple of lectures in Honolulu, a hardship tour 0021 1 in April. 2 Q. Okay. 3 A. I hope to meet with him and examine 4 him. It's always my preference to examine 5 someone who I may be meeting in courtroom 6 litigation. So if that can be arranged, I 7 certainly want to do that. 8 Q. Okay. I saw your report. At the 9 end you mentioned that you might want to go to 10 Hawaii and I wondered if that was something 11 that has -- has that been arranged at all? 12 A. Yes. But it wasn't arranged for 13 Mr. Sullivan. Speaking with a couple medical 14 organizations in Hawaii it provides an 15 opportunity for me to meet with him and -- 16 MR. MISHKIND: Just so you know, 17 it's going to be the second week of April since 18 he's going to be there. And we're going to 19 arrange to have Shannon seen by Dr. Conomy 20 while he's there. 21 Q. Okay. And what -- 22 MS. CARULAS: Would you like one? 23 THE WITNESS: Sure. 24 MS. CARULAS: Anyone else? 25 MR. MISHKIND: Sure. 0022 1 Q. Tell me, what is it that is taking 2 you to Hawaii? What are the talks you're going 3 to be making? 4 A. The meeting of the American Academy 5 of Neurology and the Hawaiian Neurologic 6 Society. 7 Q. And what is the subject of your 8 discussion? 9 A. I'm discussing telemedicine for 10 stroke. It's challenging because people sit in 11 the middle of the Pacific Ocean and some of the 12 land masses near them, as small as they are, 13 are governed by governments outside of the 14 United States. So how this might work should 15 be a very challenging business. What is 16 intended is a system of stroke treatment done 17 in a tele-electronic computerized method within 18 the Hawaiian Islands and probably outside of 19 it. 20 Q. You have a program already as far 21 as the talk? 22 A. Yes. 23 Q. Okay. Is that something I could 24 see? 25 A. If you want to sign up and take a 0023 1 course and pay for it, yes. Otherwise, no. 2 That has nothing to do with this. 3 Q. Do you have a copy of the syllabus? 4 I'm not interested in going to the seminar, but 5 I'm sure you have a publication that's sent 6 out -- 7 A. I can send you something. 8 Q. What's that? 9 A. I can send you something about it. 10 Q. Or we can get it before I leave? 11 MR. MISHKIND: Either that or, 12 depending on the time, if you follow up with a 13 letter to us we'll make sure that, if there's 14 something that's out there concerning the 15 seminar, we'll get it to you. 16 MS. CARULAS: Okay. 17 Q. All right. Now, as far as -- I 18 know we've discussed how these various items of 19 literature were provided to you by 20 Mr. Kulwicki. 21 Are you aware of who the authors of 22 these three first articles there on page 1 of 23 your report, what institution -- 24 A. Well, I could read them off for 25 you. I don't know them personally, but I know 0024 1 the names. What -- 2 Q. Your report. 3 A. I understand. 4 Q. Do you have it in front of you? 5 A. Yeah. I'll get it. Don't help me. 6 Q. What's that? 7 A. Don't help me. 8 Q. I'm trying to get you out of here 9 in time. 10 A. Okay. I'll keep them in order. 11 What did you ask me? 12 Q. Okay. Under learned sources, the 13 three authors -- 14 A. No. I don't know them personally. 15 They're identified institutionally. 16 Q. Okay. Do you know what 17 institutions those three individuals are from 18 without looking at the -- 19 A. Well, the Cleveland Clinic and 20 other institutions. Manufacturers of devices, 21 other medical institutions are listed on these. 22 But I don't remember them. It's not a memory 23 test. 24 Q. I'm just curious. DiBiase, Kanj 25 and Wazni, do you know what institutions 0025 1 they're from? 2 A. They're from the Cleveland Clinic. 3 It says. 4 Q. Okay. Now, are these various 5 journals that Mr. Kulwicki provided you 6 information from, are they something that you 7 review as part of your regular practice? I 8 would assume not. 9 A. Well, these are highly 10 specialized -- one of them is a circulation, 11 something I see from time to time. I think I 12 reviewed for it, too. Because it contains 13 occasional articles that have to do with stroke 14 or some manifestation of neurologic disease. 15 Generally, the American College of Cardiology, 16 that may have an article of interest from time 17 to time. Again, generally related to stroke. 18 Q. Okay. So most of these articles or 19 publications in the electrophysiology realm is 20 outside of your specialty? Not something you 21 would read regularly? 22 A. Yeah. It's outside of the things I 23 ordinarily read. 24 Q. Okay. I know you currently are -- 25 have an appointment at Case. Senior status? 0026 1 A. Right. 2 Q. Tell me what your involvement is at 3 Case. 4 A. I teach some classes. I give 5 formal lectures from time to time. Not many. 6 Clinical teaching, occasional bedside teaching. 7 My teaching load is not heavy at this point in 8 my life. 9 Q. Tell me what -- are you still going 10 to Heather Hill? 11 A. Heather Hill is in the process of 12 transition. It's being sold off to a propriety 13 -- an organization. I'm not sure what the 14 future is going to be for me or others on the 15 staff there. That remains to be seen. But at 16 least for the moment, yes. 17 Q. Okay. And how often do you go to 18 Heather Hill? 19 A. When I'm called. I would see -- 20 the highest number of patients I've ever seen 21 in a month is 90 and the low is probably five, 22 that are seen in consultation. The place is 23 staffed by hospitalists, so I generally see 24 them through hospitalists. But this is 25 becoming the case everywhere. 0027 1 Q. That hospitalists are primarily 2 managing the care? 3 A. Yes. Yes. 4 Q. Okay. 5 A. They're not alone. Hospitals 6 throughout the community do the same thing. 7 Q. In 2011, have you been called to 8 Heather Hill? 9 A. Yes. Not very many times. Let me 10 guess. I'd say a half dozen. I'm not sure of 11 the number. It's a small number. 12 Q. And if you would be called, under 13 what circumstance? Who would you see? 14 A. If the attending taking care of a 15 patient needed help with some special problem, 16 then I would get called. They can be all kinds 17 of problems. Generally, they're very old 18 people. 19 Q. Okay. So over the last, I mean, 20 two and a half months you think approximately 21 six times? 22 A. Approximately, yes. 23 Q. And for what purpose would they 24 call you? If they have intensivists, why would 25 they call you? 0028 1 A. They're not intensivists, they're 2 hospitalists. 3 Q. Okay. 4 A. People with seizures, people with 5 confusional states, fever from known infection 6 of the nervous system, trauma. 7 Q. And who are the attendings that 8 have called upon you there? 9 A. I can't remember all the staff 10 physicians from there. Not all of them do I 11 know personally. 12 Q. Okay. But can you -- you say 13 you've been called for about six? 14 A. I think so. 15 Q. Can you name any of the attendings 16 that have called you in? 17 A. I don't remember their names. 18 Q. I mean, if someone has called you 19 for a consult, you then send them a letter, I 20 would assume? 21 A. Yes, I would. 22 Q. Okay. And you -- 23 A. I dictate a consult into my chart. 24 I wouldn't necessarily send them a letter. 25 Q. You dictate it, but then it's sent 0029 1 to them, correct? 2 A. Yes. No. It goes into the chart. 3 It's not a letter that's sent personally to 4 them. 5 Q. Okay. You're unable to remember 6 the name of one of the doctors -- 7 A. I don't want to guess. 8 Q. You're going to have to wait for me 9 to -- 10 A. But I've answered it two times 11 already. I don't remember the names of the 12 people. It tends to be a pretty high turnover 13 bunch, too. It's not necessarily people I 14 know. 15 - - - - - 16 (Thereupon, Deposition Exhibit D, 17 Updated CV, was marked for purposes 18 of identification.) 19 - - - - - 20 Q. Okay. I know this is an updated 21 CV. I'm just going to mark it as D. I notice 22 on the last CV you had listed current hospital 23 appointment at Lutheran Hospital. 24 A. Correct. 25 Q. In 2011, have you seen any patients 0030 1 at Lutheran Hospital? 2 A. Just a couple. These have been 3 people who are -- local people who have 4 required immunotherapy for one or the other 5 diseases of the nervous system. 6 Q. On how many occasions in 2011 have 7 you seen a patient at Lutheran Hospital? 8 A. I think there's just been a couple 9 hospitalizations there. My hospital load is 10 quite light now, by design. 11 Q. Okay. Do you consider yourself 12 semi-retired? 13 A. No. 14 Q. Okay. You've been lightening your 15 load, you say? 16 A. Well, my week is still seven days 17 and I see patients three days a week. That 18 leaves time for some other things. I'm hardly 19 retired. Although I'm fascinated by the 20 prospect of a shorter day. 21 Q. Well, it sounds good. I apologize. 22 I don't mean to, but what is your current age? 23 A. My current age is 71. 24 Q. 71? 25 A. Um-hmm. 0031 1 Q. And your date of birth? 2 A. July 31st, 1938. The feast of 3 St. Ignatius. 4 Q. Okay. By my math, you'll be 73 in 5 July. Is that right or -- 6 A. 72. I'm 71 now. Hold on. 72 or 7 73? 8 Q. I think you're 72. 9 A. Okay. Well, time flies. 10 Q. Okay. Trust me. So you say you've 11 been called a couple times to Lutheran 12 Hospital? 13 A. Right. 14 Q. You were on a consulting basis, 15 correct? 16 A. No. Those are my patients. 17 They're there because they live on the west 18 side and it's just easier for them to go there 19 for treatment. Heather Hill is virtually 20 always consultation. 21 Q. Okay. And how is it that you -- 22 because your office is here where we're 23 located? 24 A. Right. 25 Q. How is it you have west side 0032 1 patients? Just curious. 2 A. Well, I've worked on the west side 3 before and many of my patients come from the 4 west side and prefer to stay on the west side 5 and that's fine with me. I think it's a 6 perfectly fine place and it's not that far. 7 Q. Okay. 8 A. Except for Clevelanders that don't 9 like to cross bridges. 10 Q. True. All right. 11 You mentioned that you see patients 12 three times a week? 13 A. Yes. 14 Q. Is that here in your office? 15 A. Yes, it is. 16 Q. And so what are your hours three 17 days a week? 18 A. Well, I generally start seeing 19 patients at 9:00 or 9:30 and try to end around 20 4:30. Sometimes I start earlier and work 21 later. In fact, that's very frequent. 22 Fridays, if there are hospital patients, I try 23 to see them then. If people need to be seen, 24 it's a demand situation. That goes for 25 Tuesdays and Thursdays, too. If patients need 0033 1 to be seen, I see them. 2 Q. So you see patients on what days? 3 Monday, Wednesday, Friday? 4 A. And today. Monday, Tuesday, 5 Wednesday, and then I leave town. 6 Q. Okay. So generally your office -- 7 I'm sorry. It's been a while since I deposed 8 you. 9 You see patients in your office 10 Monday, Tuesday, Wednesday? 11 A. Monday, Wednesday, Friday. That's 12 the ideal. It almost never works that way 13 because of intrusion, demand and the like. 14 Q. Okay. And then you said you leave 15 town? 16 A. No. I don't leave town. I'm 17 leaving town this week. 18 Q. I see. But as a general rule, when 19 you're not leaving town, you see patients in 20 the office Mondays, Wednesdays, Fridays? 21 A. That's correct. 22 Q. All right. And what do you do on 23 Tuesdays and Thursdays? 24 A. I see the overflow from the other 25 three days. And that's very frequent. In 0034 1 fact, it's almost constant. It leaves me time 2 for work, teaching, publication, seeing 3 patients in hospitals, nursing homes, other 4 hospitals, what happened today. 5 Q. All right. We've talked about the 6 hospitalization. 7 When is the last time you've seen a 8 patient at University Hospitals? 9 A. About -- I'm trying to think of 10 which month it was. I think it was February. 11 Q. So a patient in February? 12 A. Yes. 13 Q. And was that on a consult basis? 14 A. Yes. 15 Q. And who is it that consulted you? 16 A. A person with intractable epilepsy 17 from Chicago. 18 Q. The patient was? 19 A. Yes. 20 Q. And who was the physician who 21 consulted you? 22 A. He was on the epilepsy team. An 23 oriental guy. I forget his name. It was at 24 the family's request. 25 Q. And prior to this request from the 0035 1 family, somehow they knew you from Chicago? 2 A. No. They just knew me. 3 Q. Knew of you or -- 4 A. Yeah. 5 Q. Okay. Besides this one consult in 6 February from -- at the family's request, prior 7 to that, when is the last time you -- 8 A. Probably -- 9 Q. You're going to have to wait. 10 A. Okay. 11 Q. When was the last time you saw 12 someone at University Hospitals? 13 A. It was probably a couple months 14 earlier than that. A man with widespread 15 metastatic carcinoma. 16 Q. That was in the second half of -- 17 A. Yeah. The weather was still not 18 terrible. 19 Q. Okay. So sometime in early fall, 20 perhaps, in 2000 -- 21 A. It wasn't snowing, I remember that. 22 Q. Okay. 23 A. The sun was shining. 24 Q. Okay. And who consulted you for 25 that? 0036 1 A. His physician, a 2 gastroenterologist. 3 Q. And do you know who that physician 4 was? 5 A. That might have been Peter Yang, 6 but I'm not sure. 7 Q. In 2010, how many patients do you 8 think you saw at UH? 9 A. I don't know. It couldn't have 10 been more than a half dozen. 11 Q. Now, are you familiar with any of 12 the electrophysiologists down at University 13 Hospitals? 14 A. In the EEG department or -- which 15 one are you -- 16 Q. The cardiac electrophysiologists? 17 A. No. No. 18 Q. I'm sorry? 19 A. I thought you were asking about 20 epilepsy or EMG. No. No, I don't. I'm 21 familiar with the names and recognize them, but 22 I really don't know them. 23 Q. Okay. As you sit here right now, 24 are you able to tell me who any of the 25 electrophysiologists are at UH? 0037 1 A. No. I would have to look at a 2 list. 3 Q. Okay. I take it you do not as part 4 of your practice interact with any of the 5 electrophysiologists at University Hospitals? 6 A. Infrequently. 7 Q. Okay. When you say infrequently, 8 can you think of an experience you've had in 9 the last five years that you've interacted with 10 an electrophysiologist at University Hospitals? 11 A. Yeah. I've had a patient with a 12 pacemaker. Polish. That interaction is 13 generally carried out through cardiologists in 14 triangulation. My interactions with them are 15 quite infrequent, as I said. 16 Q. Okay. Have you ever had a patient 17 of yours, that you were seeing for a neurology 18 issue, that happened to undergo a catheter 19 ablation for a rhythm disturbance? 20 A. Yes. Not very many. Certainly 21 less than half dozen. They've all been at the 22 Cleveland Clinic. I can't tell you the names 23 of the people who have done it. There's been 24 people with abberant conduction systems, 25 Wolff-Parkinson White disorder who have 0038 1 undergone ablation. 2 Q. Now, is this back when you were at 3 the Cleveland Clinic or since you've left the 4 Clinic? 5 A. Both. 6 Q. Okay. So you recall having 7 interaction -- let me start again. 8 You recall when you were at the 9 Cleveland Clinic as a neurologist that you had 10 patients undergo catheter ablation back then? 11 A. I'm not even sure they were doing 12 catheter ablation back then. They were doing 13 some ablation surgeries. Some of these were 14 open procedures. I'm not sure of the nature of 15 catheter ablation in those days. 16 Q. So you cannot say that you had a 17 patient while you were at the Cleveland Clinic 18 undergo a catheter ablation? 19 A. I'm sure one did. This is for 20 Wolff-Parkinson White syndrome. She was my 21 secretary, so I know what happened to her. My 22 experience with that was not tremendous. 23 Q. All right. And the type of 24 procedure that your secretary had was an open 25 procedure or -- 0039 1 A. Yeah. Part of it was open, part of 2 it was not. It was complicated. I'm not sure 3 of all of the complexities. I know it was a 4 very complicated situation with multiple 5 procedures. 6 Q. You were involved in that just as a 7 bystander/friend as opposed to a treating 8 physician? 9 A. Yes. That's correct. 10 Q. Since leaving the Cleveland Clinic 11 -- and you left when? 12 A. '92. 13 Q. Have you ever had a patient of 14 yours who underwent a catheter ablation? 15 A. Yes, I have. And I see such 16 patients. Not very frequently. They're 17 generally people who have had ablation 18 procedures for atrial fibrillation, as did 19 Mr. Sullivan. I've seen them because of 20 stroke-related problems. 21 Q. All right. So you have how many 22 patients, would you say? 23 A. I would say over many years, about 24 a half dozen of those. Including a couple that 25 are still being treated. 0040 1 Q. All right. So you think you've had 2 about six patients, approximately? 3 A. Yes. 4 Q. Over what period of time? 5 A. In the last ten years. 6 Q. And are you involved at all in 7 referring the patients for the catheter 8 ablation or is that something that their 9 cardiologist was involved and not you as the 10 neurologist? 11 A. All of them involved cardiologists, 12 as far as I can remember, and all of them have 13 had stroke-related problems in spite of 14 treatment for both rhythm disturbances and clot 15 formation. I would say they've been somewhat 16 difficult patients. 17 Q. And the reason you've seen them is 18 because of the stroke complication? 19 A. Yes. Because stroke is an 20 extremely common event in atrial fibrillation. 21 Q. Okay. Did you see them because 22 they've had a stroke before cardiac ablation 23 due -- they had a stroke due to the A fib or 24 did these patients have strokes due to the 25 procedure or do you know? 0041 1 A. Well, it gets complicated. Some 2 have had strokes because of A fib before the 3 procedure, some have had strokes because of A 4 fib after the procedure. The procedure doesn't 5 always work. Some of them are redos, some of 6 them are people who need drug management in 7 spite of having ablation or having ablations 8 and pacemakers. So it gets very complicated. 9 Q. Okay. So, as you mentioned, the 10 fact that someone has atrial fibrillation, they 11 are potentially set up for a stroke in and of 12 itself? 13 A. I don't know if set up is the right 14 word. You have to put it in the right context. 15 The stroke rate in persons with atrial 16 fibrillation, particularly chronic atrial 17 fibrillation, is a multiple of some place 18 between 7 and 10 of the expected rate of stroke 19 in persons who don't have that condition. So 20 it's frequent. 21 Q. Okay. Explain that to me. You're 22 saying patients with atrial fibrillation, 23 because of the atrial fibrillation, they have 24 the risk of stroke? 25 A. They have a heightened risk. We 0042 1 all have a risk. 2 Q. Okay. We all have a risk, but one 3 with atrial fibrillation has a heightened risk? 4 A. That's correct. 5 Q. And the heightened risk in someone 6 with atrial fibrillation versus the general 7 population you say is 7 to 10 percent? 8 A. No. It's 7 to 10 fold the relative 9 rate of people without that condition. 10 Q. I see. Okay. So 7 to 10 times 11 that of -- 12 A. A controlled group. 13 Q. A controlled group. Okay. 14 And what is the yearly risk of 15 stroke for a patient who has atrial 16 fibrillation? 17 A. Well, it's, again, 7 times the age 18 matched risk for somebody who is their same age 19 and have the same condition. So it's a 20 relative number. It's not an absolute. 21 Q. Okay. Is there -- are you aware of 22 quoted statistics as far as what the yearly 23 rate or risk of having a stroke in a patient 24 with A fib is? 25 A. Well, it is age related. It's 0043 1 compounded by associated diseases. On an 2 average -- in a young woman, if it's 1 in 3 1,000, that's 7 in 1,000, 10 in 1,000, that is 4 100. There's tremendous literature written on 5 this in which numbers are conjured up in all 6 kinds of ways. The most famous, and everybody 7 knows about it, is referred to in materials. 8 Stroke prevention in atrial fibrillation. That 9 really established the efficacy of treatment 10 over all age spectra in stroke prevention. It 11 lists all groups at all risk levels and ages is 12 over 65 percent. 13 Q. So, are you able to quote for me 14 the risk of a patient -- a yearly risk of a 15 patient in someone of Mr. Sullivan's age with A 16 fib of having a stroke? 17 MR. MISHKIND: Well, let me object. 18 You're just talking about age? No reference to 19 whether -- what their CHADS2 score is, no 20 reference to whether they're treated or not? I 21 mean, you're asking to take just age only 22 irrespective of all the other factors? 23 MS. CARULAS: (Nodding head.) 24 MR. MISHKIND: Really? Okay. 25 A. That's very hard to do. That would 0044 1 be guesswork on my part. If you take a person 2 of middle age and use the number five as a base 3 for atrial fibrillation, that becomes two or 4 one and a half for treated people. It gets far 5 more complicated than that very quickly. 6 Q. Okay. So you're saying roughly a 7 one to two percent risk of stroke per year in a 8 treated -- 9 A. No. That's not what I said. 10 Q. You've got to wait until I finish 11 my question. 12 A. Yeah. I know. But your question 13 starts off with a wrong assumption. Go ahead. 14 Q. Okay. Just tell me, are you able 15 to give an opinion as to what the yearly risk 16 of stroke is all comers with A fib? First of 17 all, can you give a number for that? 18 MR. MISHKIND: Objection. 19 You can answer. 20 A. I suppose an aggregate number is 21 present. But again, it depends on age, 22 disease, hypertension, forms of treatment and 23 so forth. So I'd have to go back and look. 24 That's not an easy answer. 25 Q. Okay. Many factors -- 0045 1 A. Yes. 2 Q. -- that go into being able to quote 3 a specific percentage? 4 A. That's right. 5 Q. Okay. For Mr. Sullivan, given -- 6 looking at him, prior to him coming in for the 7 catheter ablation, do you have an opinion, 8 given all of his factors, what his yearly risk 9 of a stroke was? 10 MR. MISHKIND: Objection. 11 A. As best I can recall, and forgive 12 me if I'm not recalling correctly, it might 13 harbor around two percent if he's treated. 14 Q. Two percent if treated? 15 A. If treated. 16 Q. Okay. And when -- 17 A. And a lot more, maybe 7 or 10 18 percent, if he's not treated. 19 Q. Okay. I understand. About two 20 percent if he's treated. 21 And when you say if treated, what 22 do you refer to with that? 23 A. Anticoagulation. 24 Q. Okay. And if not being 25 anticoagulated, 7 to 10, roughly? 0046 1 A. Roughly. But again, I don't want 2 to be hedged into those numbers as concrete 3 numbers because they are not. Okay? I'm 4 talking about relative risk reductions. Okay? 5 Q. Okay. 6 A. That's as good as you get. 7 Q. All right. And you would agree 8 that, I think you touched on this, that while 9 anticoagulation can decrease once's risk for a 10 stroke, it does not eliminate the risk of a 11 stroke? 12 A. That's correct. Again, there's a 13 risk of a stroke in everybody that's 14 irreducible. With treatment it's a tad higher 15 than that. Without treatment, without 16 anticoagulation, it's many times that. So the 17 risk reduction is substantial with 18 anticoagulation, particularly Coumadin 19 anticoagulation. That's the standard of care. 20 Q. And we know in this particular case 21 Mr. Sullivan had -- from the description of a 22 layperson, he had a large stroke? 23 A. He had a very large stroke, yes. 24 That's very fair to say. 25 Q. How is it that, as a specialist in 0047 1 strokes, some patients have minor strokes and 2 some have large stroke? 3 A. Well, it all depends on the volume 4 of brain involved. That's the fundamental 5 factor. Not only degree of deficit, but 6 survivability. Now, there are variations out 7 there that have to do with topography. But in 8 general, the larger volume of the brain 9 involved, the more devastating the effect is 10 upon disability. 11 Q. Can you predict whether a given 12 stroke will affect a larger amount of brain or 13 not? 14 A. In general, you can. 15 Q. Cannot? 16 A. You can. In general, you can. 17 Q. Can. 18 A. Now, there are variations that are 19 easily cited. But in general, if very large 20 vessels, such as the internal carotid, the 21 middle cerebral artery, basal artery or one of 22 the large cerebellar vessels are occluded, then 23 the volume of brain removed will be greater 24 than were a small vessel occluded. Occlusion 25 isn't the only factor. With occlusion of a 0048 1 large volume of brain comes swelling and 2 secondary effects that have to do with the 3 propagation of brain necrosis with 4 compartmental shifts, intracranial pressure 5 rises and so forth. And this is what happened 6 to him. 7 Q. I'm sure you've seen over your 8 career patients that have had small strokes? 9 A. Yes. 10 Q. And patients that have 11 unfortunately had very large strokes? 12 A. I have. 13 Q. So the main factor there is -- I 14 know he had -- he had strokes in more than one 15 distribution of the brain? 16 A. That's correct. 17 Q. So as far as being able to predict 18 where a clot will embolize, whether it will 19 affect a major part of the brain or a small 20 part of the brain? 21 A. No. That's very predictable. 22 Q. Okay. 23 A. If you know which vessels are being 24 occluded you can be pretty accurate about what 25 kind of deficits may arise from it. The degree 0049 1 of deficit trending secondary brain swelling 2 and the like is harder to predict. When that 3 occurs, as it did in him, it's generally 4 necessary to remove a portion of the skull, a 5 portion of the brain. Those patients will 6 certainly undergo what anyone, I think, would 7 admit is a horrific and heroic procedure. But 8 it can be lifesaving. 9 Q. Okay. I know you mentioned in your 10 report that he suffered extensive and near 11 fatal sequelae requiring extraordinary medical 12 care, craniotomies and an abundant removal of 13 brain tissue? 14 A. That's correct. 15 Q. Okay. So he did have extraordinary 16 care which saved his life? 17 MR. MISHKIND: Objection. 18 A. That's my opinion. 19 Q. Okay. Are you able to -- you 20 mentioned that you know of about six patients 21 of yours that have had strokes either as a 22 result of the A fib itself or secondary to 23 catheter ablations. Well, let me start over. 24 You probably know more patients 25 than the six that have had strokes due to A 0050 1 fib? 2 A. Yes. 3 Q. Okay. Can you approximate for me 4 how many patients over your career that have 5 had strokes due to atrial fibrillation? 6 A. Oh, gosh. It goes back a long 7 time. I'd say more than 50. It's that way 8 because this is not an uncommon cause of 9 stroke. 10 Q. Okay. Have any of those -- when 11 you say more than 50, 100 or -- 12 A. I don't know. A lot. 13 Q. A lot. Okay. And have any of 14 those strokes due to the atrial fibrillation 15 been as significant as Mr. Sullivan's stroke? 16 A. Significant in what way? Requiring 17 a craniotomy? 18 Q. Right. 19 A. I recall one other person that I 20 saw at the extended care campus, Heather Hill, 21 that was in about the same shape. It did not 22 involve catheterization, just a very, very 23 large stroke. I recall a couple women from the 24 same institution that had the same sort of 25 thing. And I don't know if I recall if it 0051 1 required decompressive craniotomy, but I've 2 certainly seen people with devastating strokes. 3 A stroke can be just as devastating without 4 removal of part of the brain. 5 Q. Okay. So no question you've seen 6 devastating strokes in patients with atrial 7 fibrillation? As a result of the atrial 8 fibrillation? 9 A. Yes. 10 Q. So the number of approximately six 11 patients that you mentioned to me a little bit 12 ago were patients that have actually had a 13 catheter ablation for atrial fibrillation? Or 14 do you think they, perhaps, would have been 15 open procedures? 16 A. I can't think of a patient with an 17 ablation procedure, open or otherwise. I'm 18 just not that familiar or recollecting just how 19 the ablations were done. I've not seen another 20 one who required a craniotomy and brain 21 removal. 22 Q. Okay. But you are aware of about 23 six patients who have had strokes you believe 24 secondary to -- 25 A. Atrial fibrillation. 0052 1 Q. Oh. Atrial fibrillation? 2 A. Yeah. 3 Q. Maybe I misunderstood you earlier. 4 Have you, yourself, cared for any 5 patients who have had a stroke after a 6 catheter-based ablation for the atrial 7 fibrillation? 8 A. No. Not after -- not the kind of 9 stroke he had. I've seen people who've had 10 strokes after ablation procedures, but they've 11 not required removal of their -- 12 Q. Okay. I want to talk all strokes. 13 Okay? 14 A. Okay. 15 Q. Do you believe you, Dr. Conomy, 16 have seen patients who have suffered -- who 17 suffered a stroke, small, large, any type of 18 stroke, after a catheter ablation for atrial 19 fibrillation? 20 A. Yes. I've seen people who have 21 suffered strokes after catheter ablation. The 22 one I'm recollecting -- and there may be more 23 than one, I don't have a file in front of me at 24 all -- was sometime after the catheter 25 ablation. 0053 1 Q. Okay. So -- I know earlier you 2 mentioned six. That was talking more in 3 general with atrial fibrillation? 4 A. Yes. 5 Q. Which is more -- greater 50? 6 A. Right. Greater than what? 7 Q. You told me you've seen greater 8 than 50 -- 9 A. Yeah. Right. But I can't 10 remember. 11 MR. MISHKIND: Doctor, you've got 12 to wait until Anna is finished. 13 A. Yeah. I can't remember the 14 specifics of all of them. Go ahead. 15 Q. Okay. I want to make sure I 16 understand. When I leave here I don't want to 17 read your transcript over and say, what the 18 heck was he saying. 19 A. You probably will anyhow. 20 Q. I'm just talking about some of the 21 big words you used. That's -- 22 MR. MISHKIND: A little cross talk. 23 MS. CARULAS: Yeah. 24 Q. Originally when I asked you have 25 you seen any patients who have undergone 0054 1 catheter ablations for atrial fibrillation who 2 have had a stroke and you said approximately 3 six -- let me finish. 4 A. All right. 5 Q. Then we talked about how you 6 believed -- but as you sit here and reflect 7 further you can think of one patient that has 8 had a stroke after a catheter ablation; is that 9 fair? 10 A. That's correct. 11 Q. Okay. And the six you were talking 12 about earlier was in reference to what? 13 A. They're people who reverted to 14 atrial fibrillation in spite of this. Some of 15 them -- I can't remember how many had 16 pacemakers, but they had strokes anyhow. They 17 didn't have it at the same time or same setting 18 as Mr. Sullivan did. I don't recall seeing 19 anybody just like Mr. Sullivan. 20 Q. Okay. So the approximately six 21 you're talking about are patients who had a 22 catheter ablation, unfortunately reverted back 23 into the abnormal rhythm -- 24 A. Correct. 25 Q. -- which is a known phenomenon, 0055 1 correct? 2 A. Um-hmm. 3 Q. You need to say yes or no. 4 A. Yes. 5 Q. And then subsequently they had a 6 stroke due to their A fib? 7 A. Correct. 8 Q. All right. But you feel you've 9 only seen over your career one patient who you 10 felt a stroke was in -- somehow related to the 11 ablation procedure as opposed to the underlying 12 A fib disease? 13 A. I'm not sure what it was. It was a 14 late middle-aged barber undergoing a procedure 15 like this who died on the table of, I believe, 16 a stroke. Again, I've never seen anyone with 17 this procedure either. This is a new and 18 purportedly experimental procedure. 19 Q. I thought you mentioned a minute 20 ago -- you said this patient died on the table. 21 A minute ago you said it was a patient that had 22 a stroke quite sometime down the road after the 23 procedure. 24 A. The other ones I've seen have had 25 strokes down the road. In spite of ablation 0056 1 procedures, that couldn't be controlled even 2 with pacemakers and drugs. They had 3 fibrillation recur and had strokes. That is 4 not uncommon. 5 Q. Okay. So as far as being able to 6 say that any patients of yours that have 7 undergone catheter ablation for A fib, are you 8 able to say that any of those patients had a 9 stroke secondary to the procedure? 10 A. Not other than the ones we've 11 talked about. The one on the table and this 12 man, Mr. Sullivan, who was not a patient. The 13 others I don't think had it as a direct result 14 of the procedure. 15 Q. Okay. So we have Mr. Sullivan, who 16 is not your patient? 17 A. Right. 18 Q. We have this other patient who you 19 say died on the table? 20 A. Um-hmm. 21 Q. Yes? 22 A. Yes. 23 Q. When was this? 24 A. This was several years ago. 25 Probably five. 0057 1 Q. And had this patient seen you 2 beforehand? 3 A. No. 4 Q. When did you become involved in the 5 case? 6 A. When he turned for the worse. 7 Q. So you were called in -- 8 A. As a consult. He was kept alive, 9 but died. 10 Q. Okay. I thought you said he died 11 on the table? 12 A. Well, he quite did. He was 13 resurrected and kept ventilated for a while. 14 Q. Okay. And where -- this was about 15 five years ago? 16 A. Um-hmm. 17 Q. So in the early 2000s? 18 A. Um-hmm. 19 Q. Where did this take place? 20 A. At the Clinic. 21 Q. And you were called in as a 22 consult? 23 A. (Nodding head.) 24 MR. MISHKIND: That's a yes? 25 A. Me, an ex-member of the tribe, was 0058 1 called in as I am today -- 2 Q. Okay. 3 A. -- for a related problem. 4 Q. All right. 5 A. And this is usually at the request 6 of another physician or the family or someone. 7 I'm pleased to do it. 8 Q. Okay. And who called you in for 9 this patient? 10 A. The doctor. I can't remember who 11 it was. You know the way it works. The family 12 asks the doctor to call somebody, the doctor 13 agrees with them and does it. 14 Q. Okay. Who was the 15 electrophysiologist who performed this 16 procedure? 17 A. I don't know. 18 Q. Who was the -- did you have some 19 personal relationship with this patient or the 20 patient's family? 21 A. Both. 22 Q. Okay. But you'd not seen the 23 patient beforehand? 24 A. No. 25 Q. And you're saying this was a 0059 1 personal friend basically? You knew the family 2 and -- 3 A. My barber. 4 Q. Oh. Your barber. I see. 5 A. When I needed one. I have given up 6 that luxury. 7 Q. Okay. So you were then called in 8 for this -- 9 A. Disaster. 10 Q. Disaster. Okay. Tell me about the 11 circumstances. 12 A. I just have, I think. Problem in 13 the course of ablation and had a fatal stroke. 14 Q. Okay. And the name of this 15 gentleman? 16 A. I can't tell you. I'm sorry. 17 Q. Can't tell me for -- why? 18 A. Well, it's a confidential matter. 19 I can't discuss other patients -- 20 MR. MISHKIND: Aren't you familiar 21 with the barber-physician privilege? 22 MS. CARULAS: Okay. Here you go. 23 Q. Okay. But as far as the details of 24 what that procedure involved, who was involved, 25 unable to comment on that? 0060 1 A. No, I can't. 2 Q. And the nature of the stroke that 3 happened, that you say led to the patient's 4 demise, do you remember any of the details of 5 that? 6 A. It was a brain stem stroke. 7 Q. And how long did the patient live 8 after that? 9 A. Not long. A few hours. 10 Q. Okay. So that would be your only 11 -- your barber is your only experience of a 12 patient who has undergone an -- 13 A. An acute event. 14 Q. -- acute event? 15 A. Acute fatal or near fatal event. 16 That's my experience with it. 17 Q. All right. Now, as far as what 18 would be considered the -- I know you said 19 you're not going to give opinions as to the 20 standard of care for an electrophysiologist, 21 but are you in general aware of the -- let me 22 ask you this. 23 As far as what the risks are of an 24 ablation procedure for atrial fibrillation, 25 would you defer to an electrophysiologist as 0061 1 far as the specific listing of the risks? 2 A. Well, yes, I would. The risks are 3 well known and published. They're predictable. 4 They're not very odd things. They have to do 5 with mechanical manipulation, tissue injuries, 6 precipitation of other arrhythmias and so 7 forth. It's hard to imagine. They're well 8 published, I think. 9 Q. Okay. But as far as actually 10 listing the risks and the percentage likelihood 11 of a complication due to a catheter ablation 12 procedure, you would defer to an 13 electrophysiologist? 14 A. Yes, I would. 15 Q. That was yes, I would? 16 A. Yes. Yeah. 17 Q. In general, however, you would 18 agree that stroke is a well known and 19 recognized complication of the procedure? 20 A. Yeah. 21 MR. MISHKIND: Let me just object. 22 When you say of the procedure -- just so the 23 record is clear, when you say the procedure, he 24 may be talking generically. I'm not sure 25 you're talking specifically -- 0062 1 MS. CARULAS: I'll rephrase it. 2 MR. MISHKIND: Excuse me. As it 3 relates to the procedure that was done in this 4 case. 5 Q. Okay. You're familiar with the 6 type -- in general terms, you understand the 7 procedure that was performed in this case? 8 A. I do. 9 Q. Fair enough that you do not hold 10 yourself out as having special expertise in 11 that particular procedure? 12 A. I am not. 13 Q. As a general known concept, 14 however, you were aware that the type of 15 procedure that Mr. Sullivan underwent at the 16 Cleveland Clinic carries with it the well known 17 and recognized complication of stroke? 18 MR. MISHKIND: Objection. 19 A. It's a known complication. 20 Procedures like the one he had, yes. 21 Q. Okay. And before you had mentioned 22 how anticoagulation in general can diminish the 23 risk of a stroke in A fib. 24 We talked about that, correct? 25 A. Yes. 0063 1 Q. You would agree with the general 2 concept that while anticoagulation may decrease 3 the risk of a stroke during a procedure such as 4 Mr. Sullivan underwent, that anticoagulation 5 cannot eliminate all risks of stroke from this 6 procedure? 7 MR. MISHKIND: Objection. 8 MR. KULWICKI: Objection. 9 A. Yes. I recognize that. 10 Q. Now, there are a number of other 11 experts in this case that have authored 12 reports. 13 MR. MISHKIND: I'll save you the 14 time. He hasn't seen any of them. You can go 15 ahead and ask, but he's not seen any of the 16 expert reports. 17 MS. CARULAS: Okay. 18 MR. KULWICKI: Crowly. 19 MR. MISHKIND: That's the 20 physiatrist. 21 MR. KULWICKI: Oh. 22 MS. CARULAS: Okay. I appreciate 23 the heads up. 24 Q. You -- 25 MR. MISHKIND: Other than Crowly, 0064 1 the physiatrist, he hasn't seen any of the 2 standard of care or causation. Crowly is 3 physiatry. 4 MS. CARULAS: Okay. 5 Q. All right. You agree with what 6 Mr. Mishkind just said? You have been provided 7 with a report of a physiatrist by the name of 8 Crowly, correct? 9 A. I have. 10 Q. There are a number of other 11 individuals and specialists who have written 12 reports in this case. 13 You have not seen any other 14 reports? 15 A. I've seen no other expert reports. 16 Q. Okay. There is a neurologist by 17 the name of Steven, S-T-E-V-E-N, Levine, M.D. 18 Do you know Dr. Levine? 19 A. I think he's the head of the Stroke 20 Service at New York. Which institution? 21 Q. Okay. According to a report here, 22 he is at the University Hospital of Brooklyn. 23 A. Okay. 24 Q. Do you know him? 25 A. Yeah. Well, I've seen him at 0065 1 meetings and heard him speak. I'm not 2 personally entwined with him. 3 Q. Okay. Are you familiar with a 4 gentleman by the name of David Callans, 5 C-A-L-L-A-N-S? 6 A. No, I'm not. 7 Q. Okay. Are you familiar with a 8 gentleman by name of John S. MacGregor, 9 M-A-C-G-R-E-G-O-R? 10 A. No. Lassie. 11 Q. I'm sorry? 12 A. No, I'm not. 13 Q. I missed it. 14 A. Lassie MacGregor. No, I'm not 15 familiar with Dr. MacGregor. 16 MR. MISHKIND: When you refer to a 17 gentleman, it's Dr. MacGregor. 18 MS. CARULAS: Yeah. I mean, I -- 19 MR. MISHKIND: Just so he -- he 20 might know a gentleman by the name of 21 Mr. MacGregor that's not a physician. 22 MS. CARULAS: He's both a gentleman 23 and doctor, I would assume. 24 MR. MISHKIND: That's right. They 25 usually go hand in hand, don't they? 0066 1 Q. Are you familiar with a doctor and 2 a lawyer, you know those types, by the name of 3 Robert S. Chabon, C-H-A-B-O-N? 4 A. No. 5 Q. Are you aware of a Ph.D. doctor by 6 the name of Jonathan Marino? 7 A. No, I'm not. 8 Q. Okay. 9 A. But I'd like to be with all of them 10 if it's necessary. 11 Q. Well, if you want to spend your St. 12 Patty's Day with us, you can go ahead and read 13 it. 14 Have you, sir, taken any notes at 15 all? 16 A. No, I've not. 17 Q. I think we've touched on this. 18 While you see patients who have had 19 a stroke as perhaps a sequelae of atrial 20 fibrillation, you, yourself, do not hold 21 yourself out as an expert in the management of 22 atrial fibrillation? 23 A. Not of the atrial fibrillation. 24 I'm certainly familiar with it. In the context 25 of stroke and in the management of 0067 1 anticoagulation for people who are suffering or 2 might suffer or have suffered, I am. But not 3 in the management of a cardiac arrhythmia, per 4 se. 5 Q. Okay. And so if you had a patient 6 of yours who somehow you determined they had an 7 abnormal rhythm under examination, for 8 instance, where you suspected due to 9 symptomotology that they had atrial 10 fibrillation, for the management of that you 11 would refer them to an electrophysiologist? 12 A. Well, to a cardiologist, yes. 13 Q. Okay. And you understand that a 14 cardiologist would refer the patient to an 15 electrophysiologist -- 16 A. Not necessarily. There's many 17 patients -- 18 Q. You don't even know what I'm asking 19 you. You need to wait until I finish my 20 question. 21 Okay? 22 MR. MISHKIND: He was just 23 anticipating your question. 24 A. I thought you were done. I was 25 hoping you were done. 0068 1 Q. Yeah. I believe that. 2 MR. MISHKIND: A lot of people are 3 feeling that way. 4 MS. CARULAS: Yeah. 5 A. I'm sorry. Go ahead. 6 Q. Everyone in the room. That's okay. 7 I can take it. 8 MR. MISHKIND: You've got thick 9 skin, right? 10 MS. CARULAS: Yeah. 11 Q. You understand that if a patient is 12 desirous of having an ablation procedure for 13 atrial fibrillation, that a cardiologist refers 14 the patient to an electrophysiologist? 15 MR. MISHKIND: Objection. 16 A. Well, the cardiologist better agree 17 that's it desirous, too, because most patients 18 won't require electrophysiological ablation for 19 atrial fibrillation. They can be treated by 20 other means. 21 Q. Okay. 22 A. Now, if it resists that and it 23 turns out to be in the patient's interest to 24 have it done, yes. 25 Q. Then that cardiologist would refer 0069 1 the patient to an electrophysiologist? 2 A. That's certainly possible, yes. 3 Q. Okay. All right. If we can, let's 4 look at your report. 5 A. I've got it. 6 Q. All right. You list here what 7 you've described as seven opinions, correct? 8 A. That's right. 9 Q. And the first opinion is in the 10 course of PAVI -- what do you mean by PAVI? 11 A. That's the procedure. 12 Q. Okay. What do the initials stand 13 for? 14 A. Hold on a minute here. So I get 15 all of my -- all right. Pulmonary vein antrum 16 isolation. 17 Q. Okay. So the record will just 18 reflect, you looked at an article -- 19 A. Yes. 20 Q. Let me -- wait until I'm finished. 21 A. Yes. 22 Q. Let the record reflect you just 23 referred to one of the Cleveland Clinic 24 articles to look at the initials, correct? 25 A. Right. 0070 1 Q. Actually, it should be PVAI? 2 A. Yes. But that's what it is. 3 Q. All right. So this is either a 4 typo or a -- 5 A. Whatever. We all know what we're 6 talking about, so please. 7 Q. Okay. In the course of -- you have 8 PAVI, Shannon Sullivan obligately -- 9 A. Obligately. 10 Q. -- acquired a thrombogenic lesion 11 of his left cardiac atrium? 12 A. That's right. 13 Q. What do you mean by -- how do you 14 pronounce it? 15 A. How do I what? 16 Q. Obligately? 17 A. Obligately. 18 Q. Okay. 19 A. Which is a real English word. 20 What would you like? 21 Q. Yeah. I'm just curious. 22 In plain English, what are you 23 saying there? 24 A. Well, it's -- part of the procedure 25 is mechanical injury to the endothelium portion 0071 1 of the region of entry of the pulmonary vein 2 into the left atrium. That's how it's done. 3 Q. Okay. By that you mean necessary, 4 compulsory, is what you're -- 5 A. Yes. Obligately. Obliged. 6 Q. All right. So your position here 7 -- your opinion is that he developed a lesion 8 in the left cardiac atrium? 9 A. Yes. 10 Q. During the procedure? 11 A. Yes. 12 Q. Okay. And are you able to say, to 13 a reasonable degree of medical probability, 14 what the mechanism of this thrombogenic 15 lesion -- 16 A. He has catheter manipulation and 17 then he has some sort of magnetized electronic 18 ablation of the conduction system that starts 19 at the endothelium and goes to the conduction 20 fibers. 21 Q. What did you say about the 22 magnetic? 23 A. It's stimulated and produces energy 24 that destroys the conduction fibers. That's 25 injury to heart tissue. 0072 1 Q. Okay. Talking about the details of 2 this procedure, I think we've already touched 3 on this, this is not really your area of 4 expertise, to be able to explain how the 5 various instruments work and so forth? 6 A. I know how they work. By producing 7 injury to cardiac tissue. That's how they 8 work. 9 Q. Okay. Other than that generalized 10 statement, that's the extent of what you mean 11 by this number one? 12 A. Yes. That's the extent of what I 13 mean by that. 14 Q. Okay. As far as the actual 15 underlying mechanism of how the equipment does 16 what? 17 A. I'm not familiar with the 18 equipment, but I know what it does. And that's 19 what it does. 20 Q. Okay. So you're saying just the 21 equipment itself causes a lesion? 22 A. Yes. 23 Q. Okay. And when you say it's a 24 thrombogenic lesion, what do you mean by that? 25 A. Well, any injury to cardiac 0073 1 endothelium is a cellular injury and they are, 2 by definition, thrombogenic. Injure an 3 endothelial surface and get thrombogenesis. 4 Q. Okay. So by thrombogenic, you're 5 saying potentially thrombogenic? 6 A. No. I said thrombogenic. 7 Q. All right. Now, you talk about 8 this was the left cardiac atrium? 9 A. Um-hmm. 10 Q. Correct? 11 A. Yes. 12 Q. In your opinion, was the source of 13 this clot from the left atrium? 14 MR. KULWICKI: Objection. 15 A. Yes. 16 Q. And why is that? 17 A. Well, it enters the left ventricle 18 before it enters the aorta and then the carotid 19 artery. There's a possibility that because he 20 also had a robotic lesion on the right side and 21 he did have in the performance of this 22 left-sided lesion a transluminal puncture of 23 the septum, I suppose it's possible that a 24 smaller clot could have gotten through there or 25 a small clot that then became propagated. The 0074 1 point is that there's enough tissue injury 2 going on in the heart to put that clot in the 3 left atrial chamber, hence in the left 4 ventricle and hence in his brain. 5 Q. Are you able to say, to a 6 reasonable degree of medical probability, that 7 any of the procedure on the right side of the 8 heart caused or contributed to the stroke? 9 A. Well, to any degree, yes. But I 10 think it's a smaller probability of a de novo 11 lesion on the left side. 12 Q. All right. 13 MS. CARULAS: Can you read that 14 back to me? 15 (Record read.) 16 A. I think it's a smaller probability 17 than a de novo lesion on the right side. 18 Q. Okay. Early on, a little bit ago 19 you said possibility. I just want to make sure 20 I understand. Are you saying -- it's fine. 21 It's your opinion. 22 Are you saying that you have an 23 opinion, to a reasonable degree of medical 24 probability, that any intervention that took 25 place on the right side of the heart caused or 0075 1 contributed to this stroke? 2 MR. MISHKIND: Let me just object. 3 I think you mischaracterized what he said 4 before. But the record will speak for itself. 5 A. I believe I said it's a lesser 6 probability that this clot arose on the right 7 side of the heart. 8 Q. Okay. So you're unable to say to a 9 greater than 50 percent probability that any 10 procedure on the right side of the heart 11 contributed to this stroke? 12 MR. MISHKIND: Objection. 13 A. I think it's a lesser probability 14 than the one on the left side, yes. That's 15 what I said. Okay? 16 Q. Okay. I just want to know your 17 opinion when you are saying lesser probability. 18 A. That's what I said. Lesser 19 probability. 20 Q. Okay. What is a lesser 21 probability? 22 A. It's lesser than one being on the 23 left side. 24 Q. Okay. So you're unable to say, to 25 a reasonable degree of medical probability, 0076 1 which is greater than 50 percent, that anything 2 on the right side of the heart contributed to 3 this stroke? 4 MR. MISHKIND: Objection. 5 A. That's not what I said. That's 6 what you said. 7 Q. Okay. 8 A. I said what I said. I think it's 9 more likely to have this originate on the left 10 side than on the right ride. 11 Q. Okay. Why? 12 A. That's all I said. That's all I 13 can say. 14 Q. All right. Are you able to give a 15 percentage likelihood that you believe this 16 happened from the right side versus the left 17 side? 18 A. No. 19 Q. Okay. And maybe we're talking back 20 and forth. As I leave here today I want to 21 make sure I understand. 22 You will not be telling this jury 23 that you believe, to a reasonable degree of 24 medical probability, that the procedure on the 25 right side of the heart proximately caused this 0077 1 stroke? 2 MR. MISHKIND: Objection. 3 Go ahead. 4 A. I think it's less probable than a 5 lesion arising de novo on the left side. 6 Q. Okay. Now, do you have any 7 understanding as to -- so, what you're saying 8 is you believe a clot developed during the 9 procedure, correct? 10 A. Yes. 11 Q. Okay. And you understand that 12 there was imaging done prior to the procedure 13 and there was no evidence of a clot -- 14 A. I understand that. 15 Q. -- in the left atrium, correct? 16 A. I understand that. 17 Q. And do you know in the left atrium 18 what area in particular is the source of 19 embolization in patients with A fib? 20 A. It can be anywhere in the left 21 atrium. The atrial appendage harbors a good 22 many of them. They can be anywhere in the left 23 atrium. In somebody who's had -- I don't mean 24 to diminish it, but let me call it fiddling at 25 the entry of the pulmonary veins. That's not 0078 1 up in the atrium. That's in the chamber 2 itself, the posterior wall. So it can be 3 anywhere within the atrium. 4 Q. All right. Is it your 5 understanding that the left atrial appendage is 6 the primary source? 7 A. No, it's not. My notion is that 8 it's probably associated with the area that's 9 been instrumented in the course of ablating 10 conduction fibers in the AV node. 11 Q. And when you're talking about the 12 area that is being instrumented, that you 13 believe is the primary source or site of 14 embolization, what area is that? 15 A. Well, it's the primary source of 16 thrombus formation. 17 Q. Okay. All right. And what 18 specific area do you believe that is? 19 A. The atrium. Near the entry of the 20 pulmonary veins into the left atrium. 21 Q. Which you say is different than the 22 left atrial appendage? 23 A. Yes. Different than the left 24 atrial appendage. 25 Q. All right. So would you be 0079 1 surprised if the literature states that the 2 left atrial appendage is the source of 3 embolization in 90 percent of patients with A 4 fib? 5 A. No, I wouldn't be. But 90 percent 6 of people with A fib don't have an embolus from 7 a procedure. With chronic atrial fibrillation 8 the atrial appendage is -- and this is 9 particularly true of people who have valvular 10 heart disease, other congenital valve 11 deformities and so forth. But that's not the 12 case here. So, I don't believe that's the case 13 here. 14 Q. Okay. Now -- but regardless, we 15 know that the area of the left atrium and the 16 left atrial appendage was imaged -- 17 A. Yes. 18 Q. -- and was negative pre-procedure? 19 A. Yes. I know that. 20 Q. Okay. Now, looking at this patient 21 prospectively we know -- you mentioned that 22 patients with A fib have a risk of stroke and 23 this procedure itself carries with it the risk 24 of stroke? We've been through that, correct? 25 A. Yes. 0080 1 MR. MISHKIND: Objection. 2 MR. KULWICKI: Asked and answered. 3 Q. As you look at Mr. Sullivan 4 prospectively, where would he have fallen in as 5 far as being at risk for a stroke? 6 A. What? Well, I'm not sure how to 7 answer your question, but I'll try. Something 8 around 2 million people will have a stroke this 9 year. Something in the order of 200,000 will 10 have a so-called cardioembolic stroke and the 11 largest number of those are people who are 12 going to have thromboembolic disease, and the 13 largest number of those are people who are 14 going to have atrial fibrillation. Let's just 15 take a minimum number. Say it's somewhere in 16 the order of 100,000 strokes. 60 to 100,000 17 strokes per year. Given an age match, because 18 he bears that, he's going to have an elevated 19 risk of stroke by virtue of what's wrong with 20 him. He'll have risk reduction. Not by fixing 21 the arrhythmia, but by Coumadin anticoagulation 22 by a relative reduction factor of about 23 two-thirds. So that doesn't fix his arrhythmia 24 and it doesn't fix the cardiac problems of 25 cardiac insufficiency, of derivative 0081 1 arrhythmias and so forth. It prevents clot 2 formation. It doesn't dissolve clots, doesn't 3 make them go away, but it does prevent clot 4 formation that then becomes an embolus that 5 goes to the brain. I'm not sure I answered 6 what you asked me or not. 7 Q. Okay. Are you aware of what's 8 called the CHADS2? 9 A. The what? 10 Q. CHADS2 score. 11 A. Yeah, I am. But I can't tell you 12 all about it. It's a scoring system that looks 13 at risk stratification. 14 Q. Is that something you use or you 15 don't -- 16 A. No. I think it's good for 17 epidemiology studies and so forth. But it's 18 not a clinical scale. 19 Q. Just so I understand, it's not 20 something you use in your practice? 21 A. No. It's not something I use in an 22 everyday practice. 23 Q. Okay. 24 A. It's useful kind of to match up to 25 clinical studies and epidemiologic studies. 0082 1 Q. So you're unable to say what Mr. 2 Sullivan's chance -- 3 A. You know, I can't -- 4 Q. Wait. You've got to wait until I 5 finish my question. 6 A. Sure. 7 Q. You're unable to say what 8 Mr. Sullivan's CHADS2 score was prior to this 9 procedure, correct? 10 A. When you're done talking you have 11 to stop talking. Not keep talking after you 12 stop talking, so I can answer the question. 13 It's written in here what his CHADS score is. 14 I don't remember it. But I can't determine it 15 as I sit here. 16 Q. I'm going to ask it again. When I 17 say correct at the end, that usually means then 18 -- we'll go from there. I just want to have a 19 question and answer on the record. 20 You are unable to say, as we sit 21 here right now, what Mr. Sullivan's CHADS2 22 score was prior to the procedure, correct? 23 A. I've said correct and I'll say 24 correct again. 25 Q. Thank you. Now, number 2 on your 0083 1 report. You say, at the time of his procedure 2 and after it Mr. Sullivan was subliminally 3 anticoagulated. 4 Right? 5 A. Right. 6 Q. How do you define the word 7 subliminally? 8 A. Well, I think the recommendation is 9 that he should be carrying an INR value of 2 to 10 3.5. This was 1.4. So that's not going to 11 protect him. Now, he was given Heparin during 12 the procedure. It was reversed towards the -- 13 during the procedure, which leaves him 14 anticoagulated. And he's back to wherever he 15 was at the end of that procedure. 16 Q. When you use the word 17 subliminally -- I looked that up in the 18 dictionary. It's defined as below the 19 threshold of sensation or conscious awareness. 20 I think of subliminal as like a subliminal 21 advertisement. 22 A. Well, I'm pleased to hear what you 23 think, but I'll go look that up again. What I 24 mean by it is not enough. 25 What did you look it up in? 0084 1 Q. Well, how do you define subliminal? 2 A. Not enough. Insufficient. 3 Q. Okay. Did you mean suboptimal? 4 A. Could be. 5 Q. I'm not aware of subliminally being 6 used at all in any of the literature on 7 anticoagulation or treatment of A fib or 8 anything of that nature. 9 You stand by the use of 10 subliminally? 11 A. Well, if you want to take a break 12 I'm sure I can go worm my way into some kind of 13 definition that will -- 14 Q. You're comfortable with that word 15 staying there? 16 A. Well, I want you to be comfortable, 17 too. I mean not enough. 18 MR. KULWICKI: It's actually 19 properly used. I have the definition right 20 here. Another definition of subliminal is not 21 enough. 22 MR. MISHKIND: Less than the 23 minimum intensity or duration required to 24 elicit a response. 25 MS. CARULAS: Interesting. 0085 1 What source? 2 MR. KULWICKI: Dictionary -- I 3 don't know. Some dictionary. A medical 4 dictionary. 5 MS. CARULAS: What's the name of 6 it? 7 MR. KULWICKI: It's called the Free 8 Dictionary. It's the first one that popped up 9 on my Android. 10 MS. CARULAS: Okay. 11 THE WITNESS: Can we take a break? 12 MS. CARULAS: Okay. 13 (Thereupon, a short break was taken.) 14 BY MS. CARULAS: 15 Q. So you brought with you a 16 dictionary? 17 A. It's the Oxford English Dictionary. 18 Q. Okay. 19 A. You should bring one with you. 20 Now, let me have that and I'll put it away. 21 Q. Okay. You had pointed out here 22 that it says, below the threshold. And then, 23 in parentheses, of consciousness, number 1. 24 I'm just going to read it. 25 A. But you're reading it selectively. 0086 1 Why don't you start at the beginning. 2 Q. Okay. Subliminal. Threshold. And 3 then it goes on to all the different -- 4 A. You're not reading it. 5 Q. Number 1. It's an adjective. 6 Below a threshold or lower limit. 7 Specifically, below the threshold of sensation 8 or consciousness of a state supposed to exist, 9 but not strong enough to be recognized. 10 A. Okay. 11 Q. Okay. Is that your definition? 12 A. My definition? That's the Oxford 13 English Dictionary's definition. 14 Q. Okay. 15 A. Hopefully, it will be yours. Now, 16 let me put this away. 17 Q. Okay. So your statement here that 18 the patient was subliminally anticoagulated, 19 you're talking about the Coumadin level? 20 A. I am. 21 Q. And so your statement is -- your 22 understanding -- at least your opinion -- let 23 me start over. 24 Your opinion is that Mr. Sullivan 25 was not -- was not adequately anticoagulated 0087 1 during the procedure, correct? 2 A. Well, coming into it he was not. 3 So he was not during until he got Heparin. 4 Then he was. There's a suggestion on one of 5 the papers, I forget which one, on the 6 pre-ablation care of patients, that they be 7 anticoagulated adequately for a two-month 8 period before the procedure. 9 Q. So the basis of your opinion that 10 -- and again we know you're not talking on what 11 is the standard of care for an 12 electrophysiologist, but your general premise 13 for your causation opinion is that he was 14 subliminally anticoagulated, correct? 15 A. Subliminally, suboptimally, 16 insufficiently, not adequately, yes. 17 Q. All right. And the basis for you 18 saying that is the literature that was provided 19 to you by Mr. Kulwicki? 20 A. Now, he had an INR of 1.4. He had 21 an INR not sufficient to prevent clot 22 formation. 23 Q. Okay. So I understand, you've made 24 this statement, number 2, of subliminal, 25 suboptimal anticoagulation based on the 0088 1 literature that Mr. Kulwicki provided to you 2 and then the general statement that the INR was 3 1.4, correct? 4 A. Yes. Essentially correct. Now, 5 that literature about what is adequate is far 6 more dispersed than Mr. Kulwicki's literature. 7 But the answer is yes. 8 Q. Have you reviewed any other 9 literature from other institutions or any 10 additional literature from the Cleveland 11 Clinic, other than what Mr. Kulwicki provided 12 to you on the issue of anticoagulation for this 13 procedure? 14 MR. MISHKIND: Let me object as it 15 relates to reviewing literature from other 16 institutions. 17 But you can go ahead. 18 A. This is what I have with respect to 19 this particular Cleveland Clinic procedure. 20 That's all I have. 21 Q. Okay. So what you're saying is, 22 because the INR was 1.4, was not optimally 23 anticoagulated up to the time of the procedure, 24 number 1, correct? 25 A. That's correct. 0089 1 Q. You believe that during the 2 procedure he was adequately anticoagulated with 3 the Heparin, correct? 4 A. Correct. 5 Q. Now, you're certainly aware of the 6 concept of bridging with Heparin? 7 A. Yes. 8 Q. And that is done with many surgical 9 procedures where they are taken off of their 10 chronic Coumadin days before the procedure -- 11 MR. MISHKIND: Objection. 12 Q. -- and then they are given Heparin 13 during the procedure, correct? 14 A. Correct. 15 Q. You're aware of that concept? 16 A. Correct. 17 Q. And then you're aware that at the 18 end of the procedure -- do you have an 19 understanding as to why in those procedures 20 Heparin is given during the procedure? 21 A. Because it's shorter acting and 22 they can reverse it. It's easier to handle. 23 Q. So then during the procedure -- at 24 the end of the procedure the Heparin is 25 reversed with a drug called Protamine? 0090 1 A. Yes. 2 Q. You're aware of that concept? 3 A. Yes. 4 Q. Okay. And can you name some other 5 procedures where this idea of bridging with 6 Heparin is done? 7 MR. MISHKIND: Objection. 8 Relevance. 9 Go ahead. 10 A. It's done in many procedures. Most 11 of them are vascular procedures. Many of them 12 involve the heart, some involve peripheral 13 vascular diseases, certain vascular disease 14 treatment. 15 Q. All right. So you've told us you 16 believe this clot developed in the left atrium 17 during the procedure, correct? 18 A. After the procedure. I don't think 19 it developed while he was on Heparin. I think 20 this happened afterwards. After the Heparin 21 was taken away he's not being anticoagulated or 22 sufficiently anticoagulated with Coumadin. 23 Q. Okay. Because I thought you said 24 earlier that this -- your number 1 says, in the 25 course of the procedure, PAVI, he acquired a 0091 1 thrombogenic lesion. 2 A. That's exactly what it says. It 3 doesn't say he had a clot then. But he has the 4 substrate to form a clot because of obligate 5 injury. That's a consequence of the procedure 6 of ablation. 7 Q. All right. 8 A. It involves the inner surface of 9 the heart. 10 Q. All right. So you don't believe 11 this clot developed during the procedure 12 itself? 13 A. I think as long as he had Heparin 14 on board and it was active, it did not. It was 15 after that. 16 Q. Okay. And when after the procedure 17 did he develop the clot? 18 A. Well, I think as soon as they 19 reversed the Heparin clot formation starts. I 20 know that he had embolization about four hours 21 later. So it's a short time frame. 22 Q. Okay. So you know when the 23 embolization occurred. 24 When do you believe, to a 25 reasonable degree of medical probability, the 0092 1 clot developed? 2 A. It began when Heparin became 3 ineffective. Was made to become ineffective. 4 Q. Made to become ineffective is what 5 you're saying? 6 A. Yes. 7 Q. All right. And was there Heparin 8 still on board after the Protamine is given? 9 A. Well, there may be. I don't know. 10 It doesn't go away entirely. It just becomes 11 insufficient in amount to cause bleeding. 12 That's what Protamine does and that's what he 13 got. 14 Q. Okay. Is there -- are you aware of 15 the -- with the concept of bridging, that there 16 is a time period after the -- in general, the 17 concept that after the Heparin is discontinued, 18 that there's a time period before patients are 19 started back up on anticoagulation, Coumadin -- 20 MR. MISHKIND: Let me just note an 21 objection as it relates to in general as 22 opposed to specific to this case. 23 A. There may be. I realize it's 24 somewhat controversial. Not everybody believes 25 that. 0093 1 Q. Not everybody believes what? 2 A. Believes that you should wait a day 3 or two or two hours or two weeks. The issues 4 that drive quicker consumption of Coumadin 5 anticoagulation is generally the presence of a 6 stroke in somebody who has gone for a day or 7 two without Coumadin. 8 Q. You say it's controversial. 9 What do you mean by that? 10 A. Well, there's literature on each 11 side of it. 12 Q. And I know -- I've read other 13 testimony of yours where you talk about the 14 benefits of anticoagulation. There is a 15 balance. 16 There's risks with anticoagulation? 17 A. Well, like all things in life, 18 certainly. 19 Q. What's one of the -- 20 A. Well, go ahead. I want you to 21 finish your question. 22 Q. Go ahead. What are the risks of 23 anticoagulation? 24 A. Bleeding, bleeding, bleeding and 25 bleeding. Now, there's some other risks, too. 0094 1 Reactive thrombophilia, bone necrosis, on and 2 on and on and on. But those are vanishingly 3 small risks. The risks -- or the unwanted 4 effects of Coumadin are the same as its 5 intended effects. It's a matter of degree. 6 Coumadin causes bleeding, Heparin causes 7 bleeding. Many other drugs cause bleeding, 8 too. They need to be regulated. 9 Q. You mentioned that you have had 10 patients, we talked about this an hour or so 11 ago, that have suffered strokes. 12 Have you had any patients who have 13 suffered bleeding complications from being on 14 anticoagulation? 15 MR. MISHKIND: Objection. 16 MR. KULWICKI: Objection. 17 A. Yes, I have. 18 Q. Okay. 19 MS. CARULAS: That was a big one to 20 get you both going. 21 MR. MISHKIND: Yes. 22 MR. KULWICKI: As you're going down 23 this, can we have a continuing objection to 24 this line of inquiry? 25 MS. CARULAS: Sure. 0095 1 MR. KULWICKI: Thanks. 2 Q. Tell me the experiences you've had 3 of patients who have had bleeding complications 4 from anticoagulation. 5 A. I've had more than one elderly 6 person anticoagulated for either cardiac 7 arrhythmias or some other form of 8 cardiovascular disease fall and fall on their 9 head and develop fatal intracranial 10 hemorrhages. I've had patients who have had 11 both fatal and nonfatal intracerebral 12 hemorrhage from a Coumadin overdose. From 13 Heparin in the course of surgery as well. So 14 these are not drugs to be taken lightly. They 15 do have complications. Complications are 16 reduced by methods of administration and by 17 looking at how much anticoagulation is being 18 produced by the given amount of a drug. 19 Q. And you say that you've had 20 patients who have had bleeding complications in 21 the course of surgery due to anticoagulation. 22 Tell me about that. 23 A. Well, I -- 24 MR. MISHKIND: Excuse me. I just 25 want to note we have a continuing line of 0096 1 objection. I just want a specific objection as 2 to the relevance to this line of questioning as 3 it relates to this case. Go ahead, Doctor, 4 answer the question. I just want the objection 5 to be specific. 6 A. Yes. I haven't had many patients 7 who have had those sorts of complications. 8 One, a young girl in the course of endovascular 9 coiling and another person with a carotid 10 endarterectomy, that I remember. I'm sure 11 there's been others, but I don't -- 12 Q. Obviously, you weren't there? 13 These are tangentially your patients that have 14 had procedures and then you -- 15 A. Well, I'm not sure they were 16 tangential. They were my patients who were 17 having surgery or other endovascular procedures 18 for some illness. 19 Q. Okay. Number 6. You mentioned, 20 were it not for the failure of adequate 21 anticoagulation at the time of his cardiac 22 procedure, it is more probable than not that 23 Mr. Sullivan would have been spared the severe 24 stroke he suffered. The provision of such 25 anticoagulation under such circumstances as 0097 1 Mr. Sullivan endured is well established in 2 medical literature. All right. 3 So when you say the failure of 4 adequate anticoagulation, what do you mean by 5 that? 6 A. A degree of anticoagulation that's 7 sufficient for the prevention of the formation 8 of clots. 9 Q. So, you're saying that if the 10 patient had a therapeutic INR before the 11 procedure, that you believe this stroke would 12 not have occurred? 13 A. No. That's not what I said. 14 Q. Okay. 15 A. He was inadequately anticoagulated 16 before, so he's got less than a bridge. If he 17 has a bridge, the entrance and exit from the 18 bridge itself are a very low level. Okay? 19 There are those who would hold up that the 20 degree of anticoagulation needs to be in a 21 therapeutic range to begin with, that if 22 Heparin is used it can be reversed and that the 23 anticoagulation be carried through and not 24 stopped. Just continue. Again, at a level of 25 effective anticoagulation with Coumadin. 0098 1 That's my opinion. 2 Q. All right. And you -- we know 3 you're not getting into standard of care. 4 You're not expressing which arm to use? 5 A. No. I'm saying that's the 6 causation were it not for. 7 Q. Okay. 8 A. Okay? 9 Q. All right. So you've talked about 10 how there are different schools as far as how 11 to approach this, correct? 12 MR. MISHKIND: Objection. 13 Q. And you know that one school is to 14 decrease -- let me start over. 15 One school is to continue on with 16 therapeutic Coumadin throughout the procedure? 17 A. Yes. 18 Q. Another arm is to discontinue 19 Coumadin days before and bridge with Heparin, 20 correct? 21 MR. MISHKIND: Let me object to -- 22 excuse me for one second. Let me just object 23 to the reference to two schools as it relates 24 to this case. I don't believe that that's 25 relevant. Obviously, that's going to be an 0099 1 issue we're going to be fighting over, but I 2 believe in this particular case two schools is 3 not an appropriate legal argument from a 4 defense standpoint. But we can get into that. 5 I just want the record to reflect that. He can 6 still go ahead and answer your question. 7 MS. CARULAS: Okay. Sounds good. 8 MR. MISHKIND: If he remembers what 9 the question was. 10 Q. Do you want me to restate it or -- 11 A. No. There are probably more than 12 two schools of thought. I think that which is 13 born of continuing experience and safest in 14 terms of patient risk and benefit is not to 15 continue therapeutic levels of anticoagulation 16 when you know you're dealing with a 17 thrombogenic surface. 18 Q. Okay. 19 A. That is my opinion. 20 Q. All right. From what I understand, 21 what you're saying is you think if the arm of 22 continual Coumadin had been given versus the 23 arm of discontinuing Coumadin, bridging with 24 Heparin, you believe this stroke wouldn't have 25 happened? 0100 1 A. Almost. 2 Q. Okay. 3 A. If it's a continuous arm of 1.4, 4 no. If he were adequately anticoagulated, I 5 want to say 2.5, some number around there, 6 maybe a little more, then it wouldn't have 7 happened either. He would have had continuous 8 protection at a reasonable level against the 9 probability of clot formation. That 1.4 will 10 carry through -- if that's the lower level of 11 the bridge, it's not going to. It has to be 12 picked up. 13 Q. All right. Now, you have what 14 experience with this? 15 A. I want to make sure you're done 16 talking. 17 Q. What experience do you have with 18 this -- 19 A. Geez. 20 Q. -- concept? 21 A. Okay. It's this. It is not 22 uncommon for me to see people who have, for one 23 reason or another, who have atrial 24 fibrillation, have their anticoagulation 25 stopped for something. Someone either doesn't 0101 1 pick it up or picks it up at a low level later 2 or too late and they have a stroke. It's not 3 ablation. It's all kinds of things. That is 4 something I see probably three or four times a 5 year. I think it's an avoidable injury. Okay? 6 Now, we haven't talked about risks and 7 benefits. All kinds of things can happen. 8 Q. Okay. 9 A. But the intended benefit is usually 10 the one that works. This interruption done in 11 the name of I don't know what is not in the 12 interest of patient benefit. It hurts. It can 13 happen in all sorts of procedures besides this. 14 It can happen for any reason that Coumadin is 15 stopped or given inadequately. 16 Q. All right. So the basis for you 17 giving the opinion that this patient would not 18 have had a stroke if he had been -- if he would 19 have been on a therapeutic Coumadin level 20 throughout this procedure is what? I want to 21 know exactly your basis for that. 22 A. Well, I think I've given you part 23 of that basis. Again, I go back to some of the 24 Cleveland Clinic publication. This one by 25 Dr. Mohamed Kanj. I'm quoting from it. 0102 1 They're talking about this procedure, pulmonary 2 vein antrum procedures. We routinely perform 3 this procedure while patients are fully 4 anticoagulated, with a therapeutic 5 international normalized ratio (INR), between 2 6 and 3.5. Patients with chronic atrial 7 fibrillation must have therapeutic INRs for at 8 least two months before the procedure. Well, 9 if they're having it before the procedure and 10 have a brief procedure and come out of the 11 procedure, it's going to be 2.5 to 3.5 when 12 they come out. That's the bridge. 13 Q. All right. 14 A. That's the level of the bridge. 15 Okay? 16 Q. All right. So I want to leave here 17 today and I want to know every basis that 18 Dr. Conomy has for his opinion on causation 19 here. 20 Number 1 is looking at Dr. Kanj's 21 article and quoting a section from Dr. Kanj, 22 correct? 23 A. Correct. 24 Q. Okay. Besides that statement from 25 Dr. Kanj, in this article -- let me start 0103 1 again. I'm going to get to that in a minute. 2 This article was sent here and it 3 has certain highlighting on it? 4 A. Yes. 5 Q. It looks like there's certain 6 sections here that are highlighted before it 7 was copied and given to you? 8 A. Right. And then there's some more 9 that I put in there, too. 10 Q. Okay. So the section here that 11 highlights Heart Rhythm Journal, and then 12 there's a -- the first paragraph under 13 Anticoagulation Protocol is highlighted. 14 It was highlighted when sent to 15 you, correct? 16 A. Yeah. 17 Q. Okay. So this was highlighted by 18 Mr. Kulwicki and sent to you? 19 A. I don't know who highlighted it, 20 but I'm thankful to them. It's irrelevant to 21 me who highlighted it. It's an important piece 22 of that article. 23 - - - - - 24 (Thereupon, Deposition Exhibit E, 25 Article by Dr. Kanj, was marked for 0104 1 purposes of identification.) 2 - - - - - 3 Q. Okay. So Dr. Kanj's article, 4 written along with Dr. Wazni and Dr. Natale -- 5 do you know any of those gentlemen? 6 A. No. I know they're from the 7 Cleveland Clinic because of the tag on the 8 article. I don't know -- 9 Q. The Heart Rhythm -- the journal 10 entitled Heart Rhythm is not a journal that you 11 read in your regular practice? 12 A. Not regularly. But I think it's a 13 fine journal and that's a good statement. 14 There's a lot of journals I don't read 15 regularly, but I read from time to time. That 16 happens to be one of them. That statement, by 17 the way, is not isolated to that article. 18 Q. Prior to Mr. Kulwicki providing you 19 with this article authored by Dr. Kanj, do you 20 believe you would have read it? 21 A. If I had to go looking on my own 22 I'm sure, which I do all the time anyhow, I'm 23 sure it would have popped up. I just didn't do 24 it this time. I didn't have to. 25 Q. Prior to Mr. Kulwicki sending you 0105 1 this article, which I've marked as Exhibit E, 2 had you read it? 3 A. No. I had not read it prior. 4 Q. The sections here that are marked 5 off in dark highlighting, that was highlighted 6 like that prior to being sent to you, correct? 7 A. Yes, it was. The parts in yellow 8 were not, but that one -- 9 Q. The yellow highlighting is yours, 10 the dark highlighting is from Mr. Kulwicki's 11 office, correct? 12 A. I believe so. 13 Q. We've already talked about this. 14 Besides this article from Dr. Kanj 15 and the section you read, what other basis do 16 you have for your opinion on causation that 17 this stroke would not have happened if the 18 patient had had a therapeutic INR before the 19 procedure? 20 A. I'm trying to look at the page and 21 chapter for you. It's from Recommendations 22 from the American Heart Association. The 23 American College of Cardiology. Pardon me. 24 MR. KULWICKI: What did you mark as 25 -- did you mark a D? Oh. The CV is D? 0106 1 MS. CARULAS: Yes. 2 A. If I may, in the practice 3 guidelines, the American College of Cardiology, 4 already marked as Exhibit 5, there's a long 5 section. I'm not going to even begin to read 6 all of it. It's a lot of charts and graphs and 7 so forth on studies on stroke prevention in 8 atrial fibrillation with Warfarin. They go on 9 for numerous pages with numerous graphs and 10 charts to talk about what's effective and what 11 isn't. With nonvalvular atrial fibrillation 12 the requirements are a little bit lower than 13 with valvular atrial fibrillation. But the 14 range is -- was already stated in the paper 15 you've so well pointed -- hold on. I'll find 16 it for you. Between 2 and a half -- between 2 17 and 3 and a half. There are lots of atrial 18 fibrillation stroke prevention studies that are 19 listed here. There are at least eight of them. 20 They tend to come up with the same conclusions. 21 Adequate anticoagulation works in 22 terms of stroke prevention, not without risks, 23 and those are the ranges. There's a section in 24 there on discontinuation, too. The tendency 25 over time has been to shorten that period. Not 0107 1 wait a couple weeks. But this is not a 2 procedure that has involved a lot of protocol, 3 tissue transection and arterial repair. Likely 4 source of bleeding is like a heart transplant 5 or extensive coronary heart surgery. So, there 6 has to be some recognition of the kind of 7 procedure that's going on. 8 MR. MISHKIND: I think, for the 9 record, so that when we look at the transcript, 10 when you referred to Exhibit 5, that was 11 Exhibit 5 from another deposition. I don't 12 think you marked that as an exhibit. 13 MS. CARULAS: Right. I realize 14 that. 15 Q. All right. As far as -- again, 16 we've been through this. The details of -- 17 well, let me start again. 18 This Exhibit 5 from another 19 deposition, which is the American College of 20 Cardiology, American Heart Association ECS 21 [sic] 2006 guidelines, this was again provided 22 to you by Mr. Kulwicki, correct? 23 A. Right. 24 Q. And prior to him sending this to 25 you, you believe you would not have read it, 0108 1 correct? 2 A. Well, no. I have read it. The 3 American Heart Journal Guidelines. This is not 4 the first time I've seen it. 5 Q. Okay. So you would have perused it 6 before? 7 A. Yes. 8 Q. And the highlighting section here, 9 similar to the other article, this was -- the 10 highlighting area here, for instance, on page 11 e211, this was all again done by Mr. Kulwicki's 12 office? 13 A. I don't know who did it. It's 14 somebody else's deposition. Maybe they did it. 15 I don't know. That's the way it came. 16 Q. This is the way it came to you? 17 Highlighted? Correct? 18 A. Yes. 19 - - - - - 20 (Thereupon, Deposition Exhibit F, 21 ACC/AHA/ESC Practice Guidelines, was 22 marked for purposes of 23 identification.) 24 - - - - - 25 Q. We've marked it as Exhibit F? 0109 1 A. Right. 2 Q. So the basis for your opinion that 3 this stroke happened as a result of the fact 4 that Mr. Sullivan did not have a therapeutic 5 INR before the procedure is Dr. Kanj's article, 6 which we've marked as Exhibit E, and the 7 American Heart Association Guidelines, which 8 we've marked as Exhibit F? 9 A. Yeah. Well, those are only two of 10 them. There's a lot more literature on it. 11 But that's fine. They quote all of the 12 relevant studies in that on atrial 13 fibrillation. 14 Q. Okay. I want to know the basis 15 that you have for your opinions on this issue 16 of causation, that a therapeutic INR would -- 17 had he been on a therapeutic INR, that he would 18 not have suffered a stroke? 19 MR. MISHKIND: Excuse me for one 20 second. Just going back, several hours ago we 21 had gone through the literature that he cited 22 in his report. I think we've already covered 23 some of it, but not all of the literature that 24 he has indicated as sources. I don't want the 25 record to reflect just because you're 0110 1 emphasizing these two items that the other 2 literature is not part of the basis for his 3 opinions. 4 Q. Dr. Conomy, you were provided with 5 1, 2, 3, 4, 5, 6 -- it looks like a number of 6 different articles from Mr. Kulwicki and 7 Mr. Mishkind. Mr. Mishkind has now pointed you 8 to some additional sources here. I want to 9 know your opinion. Not what has come from 10 other people. I want to know the basis for 11 your opinions that you will give to a jury in 12 this case on causation. You've mentioned the 13 Kanj article, you've mentioned the American 14 Heart Association Guidelines. 15 Any other basis besides those two 16 items that will -- that support your opinions? 17 A. May I see the American College of 18 Cardiology Guidelines? This is a piece of the 19 same thing. Simply let me put it, the number 20 of studies on anticoagulation in here are 21 voluminous. There are at least eight major 22 studies. This is a comprehensive review of 23 world literature at that point. I think it's 24 sufficient, too. 25 Q. Okay. Do you know whether the two 0111 1 articles you talked about, the Kanj and the 2 American Heart Association, those two bases, or 3 anything else for that matter, do you know 4 whether or not there has been a controlled 5 study done specifically to establish that the 6 use of continuous Coumadin with therapeutic INR 7 prevents stroke versus the concept of bridging 8 that we discussed? 9 A. No. I would be surprised if there 10 were. In studies like that they have to 11 measure hard risks like death and stroke. It's 12 a pretty hard study to do. But I don't know. 13 Q. Okay. Have you looked to see 14 whether or not there -- is that something 15 you've either looked into or asked Mr. Kulwicki 16 or Mr. Mishkind, who have done research on 17 this, whether or not there has ever been a 18 controlled study on this subject? 19 A. I'm not aware of one. I'm fairly 20 familiar with stroke literature. Not of the 21 kind that you suggest. 22 Q. Okay. Are you aware of any ongoing 23 studies on -- 24 A. No, I'm not. Not with respect to 25 this particular -- what I'm speaking to is a 0112 1 controlled study with the parameters you 2 mentioned. Specifically designed for this form 3 of ablation technique. 4 Q. Okay. If there was a controlled 5 study that was ongoing to look into the issues 6 of whether stroke can be decreased with one arm 7 versus the other arm, would that establish to 8 you that it is not a well established concept 9 at this point? 10 MR. MISHKIND: Objection. 11 A. Well, I'm not sure I understand any 12 part of the question. The studies you have 13 there point, all of them, toward very large -- 14 impressively large risk reductions in 15 anticoagulation in people with atrial 16 fibrillation. To duplicate it in yet another 17 small study or procedure relative to 18 anticoagulation I think would require 19 extraordinary instruction of an institutional 20 review board. Since you've already got 21 studies, lots of them, hundreds of thousands of 22 people, that show relevant risk reductions of 23 two-thirds. Where I'd share in that board, I'd 24 ask them, you know, how much better do you want 25 to get and then ask what kind of risks do you 0113 1 have on -- the incidence of thromboembolic 2 disease is what to begin with? You don't know 3 and now you're going to reduce it. So, I think 4 there would be a lot of problems constructing a 5 study like that. 6 Q. Okay. 7 A. I've never seen one in 8 stroke-related literature and that's where 9 they'd wind up. Looking at strokes, you're 10 looking at brain disease, too. Not looking at 11 atrial fibrillation and such. Okay? 12 Q. Okay. All the things you quoted in 13 this literature here talk about atrial 14 fibrillation in general, correct? 15 A. Yes. 16 Q. I was talking about whether or not 17 you're aware of any studies that specifically 18 are looking at which arm to use, whether it's 19 continuous Coumadin, whether therapeutic INR or 20 the bridging concept and the relative risk of 21 stroke and bleeding between the two of them. I 22 want to make sure we're on the same page. 23 You're not aware of any studies 24 that have specifically looked at that issue, 25 correct? 0114 1 MR. MISHKIND: Objection. 2 A. They look specifically at that, all 3 of them. The relative risk of stroke reduction 4 in people with atrial fibrillation. What they 5 don't look at is ablation techniques. 6 Q. Right. That was exactly my point. 7 Are you aware of any controlled 8 studies that have looked at the different 9 anticoagulation arms in atrial fibrillation 10 catheter procedures? 11 MR. MISHKIND: Objection. 12 A. Where is the -- the one from the 13 Clinic? Kanj. The first one in your pile. 14 This is an advice that starts with what we do 15 from Dr. Kanj at the Cleveland Clinic. It 16 doesn't say it's a controlled study of 17 anything. It says we do this and it suggests 18 that other people do the same thing. So it's 19 not a controlled study. I am not aware of it. 20 Q. We've been over it. 21 You've not read any subsequent 22 literature from Dr. Kanj or any of the doctors 23 at the Cleveland Clinic, other than what was 24 provided to you by Mr. Kulwicki? 25 A. I have not. Not with respect to 0115 1 this proceeding, no. 2 Q. All right. Just so we're 3 absolutely clear, you've -- you're not aware of 4 any controlled study specifically on this 5 subject that we're talking about in this case, 6 catheter ablations and anticoagulation? True? 7 MR. MISHKIND: Objection. 8 Asked and answered. 9 A. There are studies about how -- what 10 people do, but they're not controlled studies. 11 Q. All right. And if a study would 12 obtain institutional review board consent to 13 look into it and if one is looking at 14 potentially two different arms and trying to 15 decide whether or not -- what the relative 16 risks of stroke versus bleeding are, that would 17 tell you that it is not an established, firm 18 concept, correct? 19 A. No. It would tell me the studies 20 haven't been done. 21 Q. Okay. 22 A. There are a lot of firm concepts 23 that don't bear on controlled studies. 24 Q. Sure. Why are controlled studies 25 done? 0116 1 A. They're done to show preference and 2 safety for one treatment over another. Now, 3 many of them have more than one arm. They have 4 blindedness, statistical analysis, informed 5 consent and a whole lot of other things with 6 it. 7 Q. And studies are done in order to 8 look at the issue oftentimes of causation and 9 whether or not one is more likely to cause 10 something or the other? 11 A. Well, in a general way, yeah. 12 They're done for all kinds of reasons. 13 Q. Okay. Now, you've told me you do 14 believe that Mr. Sullivan was adequately 15 anticoagulated during the procedure with the 16 Heparin, correct? 17 A. Yes. 18 Q. So the statement in number 7 that 19 he was not effectively anticoagulated during 20 the procedure, that was an error? You believe 21 he was? 22 A. Not quite. It's not an error. 23 He's not effectively anticoagulated with 24 Coumadin. He is with Heparin. But in terms of 25 an overall program of anticoagulation, he's not 0117 1 adequately anticoagulated. 2 Q. Okay. All right. If you do your 3 examination of Mr. Sullivan in Hawaii, I assume 4 you will prepare a report of your findings? 5 A. Certainly. 6 Q. And you will provide that report to 7 these gentlemen? 8 A. And you'll be provided, too. 9 MR. MISHKIND: You'll be the second 10 one to get it. 11 MS. CARULAS: We may meet again. 12 MR. MISHKIND: We will give you 13 that opportunity. 14 MS. CARULAS: Okay. 15 A. That will be a subliminal pleasure. 16 Q. Now, have we covered all the bases 17 for your opinions on causation? 18 A. I think we have. 19 Q. All right. If you come up with any 20 additional bases, you will let Mr. Kulwicki or 21 Mr. Mishkind know that, so I'm apprised of 22 that? 23 A. I certainly will. I'm happy with 24 that. 25 Q. Okay. 0118 1 MS. CARULAS: Thank you very much. 2 MR. MISHKIND: The doctor will read 3 the transcript. 4 (The deposition concluded at 12:26 p.m.) 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 0119 1 Whereupon, counsel was requested to give 2 instruction regarding the witness's review of 3 the transcript pursuant to the Civil Rules. 4 5 SIGNATURE: 6 Transcript review was requested pursuant to the 7 applicable Rules of Civil Procedure. 8 9 TRANSCRIPT DELIVERY: 10 Counsel was requested to give instruction 11 regarding delivery date of transcript. 12 Ms. Carulas: Original. 13 Mr. Kulwicki: Copy. 14 15 16 17 18 19 20 21 22 23 24 25 0120 1 REPORTER'S CERTIFICATE 2 The State of Ohio, ) 3 SS: 4 County of Cuyahoga. ) 5 6 I, Ashanti Edwards, a Notary Public 7 within and for the State of Ohio, duly 8 commissioned and qualified, do hereby certify 9 that the within named witness, JOHN PAUL 10 CONOMY, M.D., J.D., was by me first duly sworn 11 to testify the truth, the whole truth and 12 nothing but the truth in the cause aforesaid; 13 that the testimony then given by the 14 above-referenced witness was by me reduced to 15 stenotypy in the presence of said witness; 16 afterwards transcribed, and that the foregoing 17 is a true and correct transcription of the 18 testimony so given by the above-referenced 19 witness. 20 I do further certify that this 21 deposition was taken at the time and place in 22 the foregoing caption specified and was 23 completed without adjournment. 24 25 0121 1 I do further certify that I am not 2 a relative, counsel or attorney for either 3 party, or otherwise interested in the event of 4 this action. 5 IN WITNESS WHEREOF, I have hereunto 6 set my hand and affixed my seal of office at 7 Cleveland, Ohio, on this ________ day of 8 ___________________, 2011. 9 10 11 12 13 ________________________________ 14 Ashanti Edwards, Notary Public 15 within and for the State of Ohio 16 17 My commission expires October 14, 2012. 18 19 20 21 22 23 24 25 0122 1 DEPOSITION REVIEW CERTIFICATION OF WITNESS 2 RE: SHANNON SULLIVAN, ET AL., VS. THE 3 CLEVELAND CLINIC FOUNDATION DEPONENT: JOHN PAUL CONOMY, M.D., J.D. 4 COURT REPORTER: Ashanti Edwards, Rennillo Deposition & Discovery 5 In accordance with the Rules of Civil 6 Procedure, I have read the entire transcript of my testimony or it has been read to me. 7 I have made no changes to the testimony 8 as transcribed by the court reporter. 9 10 Date Witness 11 Sworn to and subscribed before me, a 12 Notary Public in and for said State and County, the referenced witness did personally appear 13 acknowledge that: 14 1. They have read the transcript; 2. They signed the foregoing sworn 15 statement; and 3. Their execution of this Statement is 16 of their free act and deed. 17 I have affixed my name and official seal this day of , 20 . 18 19 20 21 22 Notary Public 23 24 25 My Commission Expires: 0123 1 DEPOSITION REVIEW ERRATA & CERTIFICATION OF WITNESS 2 RE: SHANNON SULLIVAN, ET AL., VS. THE 3 CLEVELAND CLINIC FOUNDATION DEPONENT: JOHN PAUL CONOMY, M.D., J.D. 4 COURT REPORTER: Ashanti Edwards, Rennillo Deposition & Discovery 5 In accordance with the Rules of Civil 6 Procedure, I have read the entire transcript of my testimony or it has been read to me. 7 I have listed my changes on the attached 8 Errata Sheet, listing page and line numbers as well as the reason(s) for the change(s). 9 I request that these changes be entered 10 as part of the record of my testimony. 11 I have executed the Errata Sheet, as well as this Certificate, and request and authorize 12 that both be appended to the transcript of my testimony and be incorporated therein. 13 14 Date Witness 15 Sworn to and subscribed before me, a Notary Public in and for said State and County, 16 the referenced witness did personally appear and acknowledge that: 17 1. They have read the transcript; 18 2. They have listed all of their corrections in the appended Errata Sheet; 19 3. They signed the foregoing sworn statement; and 20 4. Their Errata and execution of this Statement is of their free act and deed. 21 I have affixed my name and official seal 22 this day of , 20 . 23 Notary Public 24 25 My Commission Expires: