0001 1 IN THE COURT OF COMMON PLEAS CUYAHOGA COUNTY, OHIO 2 SHANNON SULLIVAN, et al. º 3 º VS. º CASE NO. CV-09-697617 4 º THE CLEVELAND CLINIC º 5 FOUNDATION º 6 7 8 *********************************** 9 VIDEOTAPED ORAL DEPOSITION OF 10 ANDREA NATALE, M.D. 11 SEPTEMBER 7, 2010 12 *********************************** 13 14 15 VIDEOTAPED ORAL DEPOSITION OF ANDREA 16 NATALE, M.D., produced at the instance of the 17 Plaintiffs, Shannon Sullivan, et al., in the 18 above-styled and numbered cause on the 7th day of 19 September, 2010, at 8:00 a.m., before Micheal A. 20 Johnson, RPR, CRR, Notary Public in and for the 21 State of Texas, reported by machine shorthand, at 22 the offices of Texas Cardiac Arrhythmia, 23 3000 North IH-35, Suite 720, Austin, Texas, pursuant 24 to Notice of Oral Deposition, and in accordance with 25 the Ohio Rules of Civil Procedure. 0002 1 A P P E A R A N C E S 2 ON BEHALF OF THE PLAINTIFFS SHANNON SULLIVAN, ET AL.: 3 MISHKIND LAW FIRM CO., L.P.A. 4 BY: David A. Kulwicki, Esquire dkulwicki@mishkindlaw.com 5 Skylight Office Tower 1660 West Second Street, Suite 660 6 Cleveland, Ohio 44113 (216) 241-2600 7 8 ON BEHALF OF THE DEFENDANTS THE CLEVELAND CLINIC FOUNDATION: 9 ROETZEL & ANDRESS, L.P.A. 10 BY: Anna Moore Carulas, Esquire acarulas@ralaw.com 11 1375 East Ninth Street One Cleveland Center 12 Cleveland, Ohio 44114 (216) 623-0150 13 14 VIDEOGRAPHER: 15 Hank Wisrodt, Rennillo Deposition & Discovery 16 17 18 19 20 21 22 23 24 25 0003 1 INDEX OF PROCEEDINGS 2 3 ANDREA NATALE, M.D., DEPOSITION 4 EXAMINATION PAGE 5 BY MR. KULWICKI -------------------------------- 05 6 7 8 * * * * * * * * 9 10 11 INDEX OF EXHIBITS 12 EXHIBIT DESCRIPTION OF EXHIBIT PAGE 13 NO. 1 8/17/06 Procedure Record of Shannon Sullivan --------------------------- 22 14 NO. 2 Executive Summary for THERMOCOOL 15 Catheters for the Treatment of Drug Refractory Symptomatic Paroxysmal 16 Atrial Fibrillation ---------------- 23 17 NO. 3 Cleveland Clinic Archived Web Page For PVAI --------------------------- 12 18 NO. 4 The Cleveland Clinic Foundation 19 Consent to Participate in a Research Study ------------------------------ 42 20 NO. 5 Cleveland Clinic Clinical Cardiac 21 Electrophysiology Fellowship Program Supervision Policies --------------- 73 22 23 24 25 0004 1 PROCEEDINGS 2 (September 7, 2010 at 8:00 a.m.) 3 MS. CARULAS: On behalf of The 4 Cleveland Clinic, I would simply like to place an 5 objection on the record to this deposition going 6 forward of Dr. Natale. Dr. Natale was not involved 7 in the care and treatment of Mr. Sullivan and for 8 that reason I had objected to taking up his time to 9 come in here and questioning him about this. 10 Nevertheless, the plaintiffs insisted on this and we 11 took the matter to the judge and the judge suggested 12 we go forward; but nevertheless, I would like to 13 reserve my objection to it and potentially 14 subsequently raise it as well. 15 THE VIDEOGRAPHER: We're on the 16 record September 7, 2010. Time is 8 a.m. This is 17 the beginning of tape No. 1. 18 Will counsel please identify 19 themselves for the record. 20 MR. KULWICKI: My name is David 21 Kulwicki. I'm appearing on behalf of Shannon and 22 Debbie Sullivan. 23 MS. CARULAS: And Anna Carulas here 24 on behalf of The Cleveland Clinic, Dr. Burkhardt and 25 today Dr. Natale. 0005 1 THE VIDEOGRAPHER: Would the court 2 reporter please swear in the witness. 3 ANDREA NATALE, M.D. 4 having been first duly sworn, testified as follows: 5 EXAMINATION 6 BY MR. KULWICKI: 7 Q. Doctor, would you kindly introduce 8 yourself and I'm going to have you spell your first 9 and last name for the record. 10 A. Andrea Natale, A-n-d-r-e-a, N-a-t-a-l-e. 11 I'm the executive medical co-director of the Cardiac 12 Arrhythmia Institute in Austin, Texas. 13 Q. We're here on September 7, 2010, at your 14 offices in Austin, Texas. Are you currently a 15 resident of Austin, Texas? 16 A. I am. 17 Q. And do you have any plans to move from 18 the Austin area in the next year? 19 A. No. 20 Q. Doctor, let's start off by having me get 21 some background information about you and then I 22 would like to talk about your role as -- your role 23 at The Cleveland Clinic with respect to their atrial 24 fibrillation unit or department back in 2006. How 25 long have you been with the Texas Arrhythmia Center? 0006 1 A. Two and a half years. 2 Q. And prior to coming to Austin, where did 3 you work at? 4 A. The Cleveland Clinic. 5 Q. And as I alluded to, were you the head 6 of the atrial fibrillation unit? 7 A. I was the co-director with Dr. Gillinov. 8 Q. And Dr. Gillinov, is he an 9 electrophysiologist as well? 10 A. He's a surgeon. 11 Q. Did he do minimally invasive MAZE 12 procedures back in 2006 at the clinic? 13 A. They were. They were. 14 Q. Okay. 15 A. So he was. 16 Q. And in terms of your clinical practice 17 back at the clinic in 2006, was it limited to doing 18 radio frequency ablation procedures or did you do 19 other procedures? 20 A. Also device implant, but for the most 21 part catheter ablation procedures. 22 Q. In terms of your activities in 2006 at 23 The Cleveland Clinic in addition to being 24 co-director of the atrial fibrillation unit or 25 department, I assume you had other administrative 0007 1 responsibilities. Is that true? 2 A. I was the co-head of the section until 3 2005 or '6, I think, and then the last year I was 4 the head of the section. 5 Q. And by section, what do you mean? The 6 section of cardiology? 7 A. Electrophysiology. 8 Q. And in terms of your administrative 9 duties, were you ever on any peer review or quality 10 assurance committee? 11 MS. CARULAS: Objection. 12 A. I wasn't. I was part of the meeting 13 whenever we had a meeting on what you call M&M, but 14 I was not directly involved. 15 BY MR. KULWICKI: 16 Q. With respect to your duties as 17 co-director or co-head of the section -- well, 18 what's the difference between co-director and 19 co-head of the department of atrial fibrillation? 20 A. Well, the section is the entire group. 21 Atrial fibrillation is just a sort of any area of 22 interest of that group. 23 Q. Okay. And what were your duties as 24 the -- well, which were you in 2006; do you know 25 offhand? 0008 1 A. No, I don't -- I was the co-director of 2 the afib center. I'm not sure of -- I don't 3 remember when I became the -- from co-head to just 4 the only head of the section. 5 Q. And what were your duties as -- in those 6 capacities? 7 A. Just administrative. 8 Q. Would you set policies and procedures 9 for atrial fibrillation ablation procedures? 10 A. No. 11 Q. Would you be evaluating fellows in that 12 capacity? 13 A. As any other attending as the others 14 there too, I was not the only one. 15 THE REPORTER: You're going to have 16 to repeat that. I did not understand. 17 THE WITNESS: Okay. I said as all 18 the other physicians, I was not the only one in 19 charge. Every physician in the section had to 20 evaluate the fellows on a regular basis. 21 BY MR. KULWICKI: 22 Q. Now, with respect to the administrative 23 duties as co-director or co-head of the section, 24 what sort of administrative duties would there be? 25 A. Was mostly scheduling, you know, the 0009 1 clinical activity, supervising the daily schedule of 2 the physician in terms of who is assigned to the 3 lab, who is assigned to the clinic, this sort of 4 stuff. 5 Q. Now, I came across a term that there -- 6 at The Cleveland Clinic, they had an atrial 7 fibrillation registry. Can you tell me what that 8 that is. 9 A. It's not a register -- I mean, actually 10 the term was -- a database. It's a database. 11 That's all. Actually it was a database. I don't 12 believe that they would call it a registry. I think 13 it was a -- it was a database as well for any 14 other -- it was not just for afib. Any procedure 15 was logged into the database, so it was not unique 16 to atrial fibrillation. 17 Q. Okay. And what sort of information 18 would be put into the database regarding atrial 19 fibrillation ablation cases? 20 MS. CARULAS: I'm just going to have 21 a continued line of objection. 22 Go ahead. 23 A. As for any other -- or any other 24 procedure was patient demographic and acute and 25 long-term outcome. 0010 1 BY MR. KULWICKI: 2 Q. Would there also be any patient 3 identification information like the patient's name 4 or Cleveland Clinic number? 5 A. I'm not sure of that. 6 Q. Who would know that from 2006? Is there 7 a person that sort of monitored the database? 8 MS. CARULAS: Objection. 9 A. I'm not sure. 10 BY MR. KULWICKI: 11 Q. If you didn't call it the AF registry or 12 the atrial fibrillation registry, what did you call 13 that? 14 A. It's a database. 15 Q. Is it called a research outcomes 16 database? 17 A. No, it's not really research -- research 18 outcome. It's just the database is -- also serve 19 the purposes of quality assurance, you know, you 20 kind of track outcome in general including 21 complications. 22 Q. And was it used for research purposes -- 23 A. Also. 24 Q. -- ever? Yeah. 25 A. Also. 0011 1 Q. And would fellows have access to that 2 for purposes of writing research papers or -- 3 A. They would, yes. 4 Q. And would anybody -- would any device 5 manufacturers have access to that -- 6 A. No -- 7 Q. -- database? 8 A. -- they can't. 9 Q. Just clinic physician -- 10 A. This is for -- just clinic physician, 11 yes. 12 Q. Did you have any involvement back in 13 2006 with preparing or approving advertisements such 14 as Internet advertisements for the atrial 15 fibrillation center at The Cleveland Clinic? 16 MS. CARULAS: I'm going to object to 17 word "advertisement." You're talking about the 18 website? 19 MR. KULWICKI: Yes. 20 A. I was not directly involved. 21 BY MR. KULWICKI: 22 Q. Do you know who would have been back 23 in -- 24 A. We had people in the section that 25 were -- you know, I would -- might have seen to 0012 1 ensure the content was accurate, but I was not 2 directly involved. I don't know exactly the names. 3 Q. Why don't I just hand you what I'll mark 4 as Exhibit 1. It is what I've been referring to in 5 this litigation as The Cleveland Clinic archived web 6 page. And it's actually marked as plaintiff's 7 Exhibit 3 probably from a prior deposition, so I'll 8 just leave it marked as that. 9 And there is a section here that 10 talks about risks and benefits and it talks about, I 11 believe -- does it say 80 to 85 percent success 12 rate? Is that right? 13 A. I'm trying to find that. Where is that? 14 Q. I think it's in the box. 15 A. It's right there, uh-huh. 16 Q. Is that something that you would have 17 approved or something that you would have provided 18 to the people who put this website together? 19 A. Yeah. Because I -- you know, if they 20 put the number there, this is what they -- what they 21 are aware. And this is generally what -- what we 22 had in terms of success, around 80 percent. 23 Q. And that's for the paroxysmal? 24 A. It's probably generally. The paroxysmal 25 obviously was a larger proportional patient, but it 0013 1 was such a general component. The paroxysmal is 2 probably -- maybe higher than that, but it was a 3 sort of general number. 4 Q. What was the -- back in 2006, what was 5 the success rate for persistent afib? 6 MS. CARULAS: Just note an 7 objection. 8 A. You know, honestly I don't remember. 9 These are the things where the database helped 10 because the information out there. I don't 11 remember, but it was lower than 80 percent. 12 BY MR. KULWICKI: 13 Q. Was it less than 50 percent? 14 A. No. 15 Q. Did it vary by operator? 16 A. It can, sure. 17 Q. And did you train Dr. Burkhardt? 18 A. I did. 19 Q. Did you train him at the clinic? Is 20 that where he trained? 21 A. At the clinic, yes. 22 Q. And in terms of your experience at the 23 clinic, was it true that the experience of the 24 operator would affect the success rate and the 25 complication rate? 0014 1 MS. CARULAS: Note an objection. 2 Go ahead. 3 A. Well, this is true everywhere, just not 4 the clinic. 5 BY MR. KULWICKI: 6 Q. Understood, yeah. 7 A. So you can see a range from -- you know, 8 can go as low as 30 percent in people that are not 9 properly trained and they do procedures that don't 10 work. 11 Q. And why is that? Why is the 12 complication rate higher and the success rate 13 lower -- 14 A. I would say the complication rate is -- 15 one is the success rate is affected by the ability. 16 The complication rate could increase if people are 17 not properly trained, but it is -- through the 18 success rate it is more impacted on -- by the 19 experience of the operator. 20 Q. And why is that, Doctor? 21 A. Just the procedure is technically 22 challenging, so the experience of the person does -- 23 can make a difference. But there are several other 24 reasons impacting success which is the type of 25 procedure that you do. So it's -- certainly is more 0015 1 complicated than just generally saying operator 2 experience. That's one of the factors that impact 3 success. 4 Q. Does it have to do with an inexperienced 5 operator being less technically proficient at making 6 contact between the ablation catheter and the tissue 7 area that needs to be ablated? 8 MS. CARULAS: Objection. 9 A. It could. 10 BY MR. KULWICKI: 11 Q. Okay. Are there any other technical 12 factors that affect the success rate of 13 inexperienced operators? 14 A. Understanding of the anatomy, the type 15 of procedure that people do. So, yeah, several. 16 Q. Before today's deposition, did you 17 review any records or depositions or anything of 18 that nature? 19 A. Regarding this specific case? 20 Q. This lawsuit, yeah, about this. 21 A. Very minimal stuff. 22 Q. What did you look at? 23 A. I just looked at the report from the 24 procedure, you know, some of the -- very quickly. 25 Q. Did you review Dr. Burkhardt's 0016 1 deposition? 2 A. No, I did not. 3 Q. Did you talk to Dr. Burkhardt about -- 4 A. No -- 5 Q. -- this case? 6 A. -- I didn't. 7 Q. Do you remember this patient in the 8 sense of the clinical scenario? 9 A. Very vaguely because I was not involved 10 in his care. I just knew that this happened because 11 I was informed when this happened, but I never 12 really saw the patient personally. 13 Q. When we looked back at the audit trail, 14 there was -- in -- there was evidence that you had 15 actually looked at this patient's chart at some 16 point in time. Do you have any recollection of 17 having done so? 18 MS. CARULAS: Objection. 19 A. No. 20 BY MR. KULWICKI: 21 Q. Can you think of, since you weren't 22 involved in the patient's care, any reason why you 23 would have been looking at his chart? 24 MS. CARULAS: Note an objection. 25 A. No particular reason. You know, at some 0017 1 time a patient come to the clinic and they need a 2 test and the nurse asks us to order the test, but 3 that doesn't mean that we look at the chart. They 4 enter our name as the physician of record to order 5 the test. That doesn't mean that we, you know, meet 6 the patient or go over the chart. 7 BY MR. KULWICKI: 8 Q. With respect to the clinical scenario, 9 at the time of Mr. Sullivan's stroke, was he the 10 worst outcome that the clinic had had as of that 11 point in time in doing catheter ablation on a 12 patient? 13 MS. CARULAS: Objection. 14 A. No. There are other patients that 15 have -- you know, this is -- that's one of the 16 complications of the procedure. 17 BY MR. KULWICKI: 18 Q. With respect to your role as -- well, 19 strike that. 20 Doctor, in addition to your 21 activities with performing atrial fibrillation 22 ablation and your administrative responsibilities at 23 the clinic back in 2006, it's my understanding that 24 you were the -- you were a principal investigator 25 for the NAVISTAR THERMOCOOL catheter ablation of a 0018 1 paroxysmal atrial fibrillation study; is that 2 correct? 3 A. Yes. 4 Q. And how many principal investigators 5 were there? 6 A. Well, at the clinic I was the -- 7 there -- around the nation more than 40 centers, I 8 think, something like that. 9 Q. And you were the only one at the clinic? 10 A. Everybody else that was involved in 11 ablation was a coinvestigator. This is usually the 12 way we research. 13 Q. Would Dr. Burkhardt have been a 14 coinvestigator, then? 15 A. I don't remember. He might. 16 Q. How would you find that out? 17 A. If you look at the paper in the 18 appendix, they should list all the co-investigators. 19 Q. As a principal investigator, what would 20 your role and responsibility be, generally speaking? 21 A. Just to make sure the patient was 22 enrolled in the study based on the protocol 23 requirement and they would do the follow-up. So for 24 the most part that was the reason. 25 Q. And would you have reporting duties with 0019 1 respect to outcomes from the study in terms of 2 reporting that to the device manufacturer? 3 A. I would -- reporting was not to the 4 device manufacturer; to the FDA. 5 Q. Did you have any sort of connection with 6 the device manufacturer that manufactured the 7 THERMOCOOL catheters in terms of did you have any 8 kind of consulting agreement with them or research 9 agreement or employment relationship? 10 A. No employment relationship. As with all 11 the other companies, we worked with the industry to 12 develop tools, to assess tools. That's sort of the 13 type of relationship. 14 Q. Did you have any sort of consulting 15 arrangement with them? 16 A. Not on a regular basis. Only, you know, 17 once a year if I could attend their advisory board, 18 that was the only agreement. It would be just the 19 one-time agreement. 20 Q. And was Dr. Burkhardt back in 2006 on 21 Biosense Webster's advisory board? 22 A. I'm sure. 23 Q. Did you have any regular communications 24 with Biosense Webster about outcomes from the use of 25 their devices, in particular catheters? 0020 1 A. Not regularly. I mean, might happen 2 during some of the advisory board meetings, but not 3 on a regular basis. 4 Q. When I took Dr. Burkhardt's deposition 5 he told me that there would frequently be device 6 reps that would be present during procedures like 7 Mr. Sullivan's procedure. Would those device reps 8 be told about outcomes like adverse outcomes? 9 A. No. 10 Q. Was there any way in which The Cleveland 11 Clinic communicated adverse outcomes to device 12 manufacturers even when a procedure like this was 13 done where it was an off-label use of -- 14 A. No. 15 Q. -- an investigational device? 16 A. No. 17 Q. How would the device manufacturers be 18 aware of risks associated with their product if the 19 physicians weren't reporting back to them? 20 MS. CARULAS: Just note an 21 objection. 22 Go ahead. 23 A. We have to report only if we feel that 24 there is an issue with the product, you now. But if 25 it is a regular complication of the procedure, then 0021 1 we don't have to report to the company. That's -- 2 you know, it's a clinical issue, it has nothing to 3 do with their device. So only if we have the 4 perception that there is a malfunction, then we 5 report it to them so that they can take the proper 6 action, not for what we consider regular -- you 7 know, standard complication for, you know, specific 8 procedures. 9 BY MR. KULWICKI: 10 Q. The paroxysmal atrial fibrillation study 11 that we mentioned earlier, I believe it started 12 enrollment in 2005 and then the study was closed in 13 2009; is that correct? 14 A. No, I don't remember exactly the time. 15 It sounds right, yeah. But probably the enrollment 16 stopped long before 2009. 2009 is including the 17 full op because the requirement was a year full ops. 18 Q. Right. And the purpose of that study 19 was to determine whether or not catheter ablation 20 was safe and effective for treatment of paroxysmal 21 atrial fibrillation, true? 22 A. Yes. 23 Q. And as part of your role as principal 24 investigator at The Cleveland Clinic in monitoring 25 that study or your involvement in that study, did 0022 1 you have to go to The Cleveland Clinic's IRB to get 2 approval of an informed consent form that would be 3 given to study participants? 4 A. Yes. 5 Q. Now, Mr. Sullivan was not a study 6 participant -- not in that study, correct? 7 A. Was not. 8 Q. Was he in any other studies that you're 9 aware of? 10 A. Nothing that I'm aware of. 11 Q. One of the things that I wanted to ask 12 you about is on this record there's a note -- and 13 I'll just hand you what I'll mark as exhibit -- I'll 14 mark this as Exhibit 1. 15 (Deposition Exhibit No. 1 marked.) 16 BY MR. KULWICKI: 17 Q. Here's the procedural sedation record of 18 Mr. Sullivan, and in the upper right-hand corner 19 there's -- it says TCI/SP. And I think I know what 20 TCI means, but do you know what "SP" stands for? 21 A. What does it mean? I don't even know 22 what TCI means. 23 Q. To come in. 24 A. To come in. Okay. 25 Q. All right. So you don't know what any 0023 1 of that means? 2 A. No. 3 Q. Now, I'm going to hand you what I'll 4 mark as Exhibit 2. 5 (Deposition Exhibit No. 2 marked.) 6 BY MR. KULWICKI: 7 Q. And this is a portion of the executive 8 summary from the study that we're talking about, the 9 THERMOCOOL catheter study for the treatment of 10 paroxysmal atrial fibrillation. I'm assuming you've 11 seen this document before? 12 A. Yes. 13 Q. And the conclusion reached was that 14 there was a -- and correct me if I'm wrong. That 15 there was a 62 percent success rate reported for 16 that procedure; is that right? 17 A. Probably maybe 66 or something like 18 this. 19 Q. I can show you and you can tell me if 20 I'm wrong. And I'm looking at page 7 of the 21 executive summary, this highlighted portion there. 22 A. Okay. 23 Q. And would you agree that the reported 24 success rate for treatment of paroxysmal atrial 25 fibrillation was 62 percent? 0024 1 A. That's what it says. 2 Q. Okay. And then going down further, the 3 other highlighted portion it lists a complication 4 rate at around 10 percent; is that correct? 5 A. 7. 6 MS. CARULAS: And I'm just going to 7 have a continuing line of objection to anything that 8 was published after the fact. Okay? 9 A. Yeah, 7 percent. 10 BY MR. KULWICKI: 11 Q. And with respect to persistent -- 12 treatment of persistent afib like Mr. Sullivan had, 13 can we agree that the success rate was actually 14 lower than with paroxysmal afib and that the 15 complication rate was actually higher than with -- 16 A. No. 17 Q. -- treatment of paroxysmal -- 18 A. The complication rate is not necessarily 19 higher. The success rate is lower, but doesn't mean 20 that this is your market point. You know, as we 21 said before it depends on your data. So this is a 22 composite experience center with a variety of 23 expertise and experience. So this number doesn't 24 mean that this is your benchmark for, you know, the 25 average... 0025 1 Q. But likewise, at The Cleveland Clinic 2 there would be a variety of techniques and 3 experience levels of physicians performing -- 4 A. No, actually the technique was the same. 5 The technique was the same. We -- everybody used 6 the same approach, at least when I -- until I was 7 there. 8 Q. So that was PVAI? Is that -- 9 A. Antrum isolation. 10 Q. Say again. 11 A. Antrum isolation. 12 Q. And same thing as PVAI -- 13 A. Yeah. 14 Q. -- right? 15 But in terms of experience level of 16 the operators, that varied at The Cleveland Clinic, 17 true? 18 A. It did. 19 Q. Yeah. 20 A. Sure. 21 Q. Now, were the success rates for -- well, 22 strike that. 23 Do you have any patents for any of 24 the devices used in atrial fibrillation ablation? 25 MS. CARULAS: Objection. 0026 1 A. I have patent, but not including 2 commercially-used devices. 3 BY MR. KULWICKI: 4 Q. And how about Dr. Burkhardt, to your 5 knowledge, did he have any patents? 6 A. I'm not sure. 7 Q. Now, you currently work with 8 Dr. Burkhardt; is that correct? 9 A. Yes. 10 Q. And how did it come that he wound up 11 here in Texas with you? 12 MS. CARULAS: Just note an 13 objection. 14 Go ahead. 15 A. Because he's a good person to have and 16 he, you know, agreed to leave as -- two other 17 physicians and five nurses, so several people that 18 came here from Cleveland. 19 BY MR. KULWICKI: 20 Q. Do you know if back in 2006 Biosense 21 Webster or -- well, let's stick with Biosense 22 Webster or Johnson & Johnson -- made any donations 23 to The Cleveland Clinic to assist in the development 24 of its atrial fibrillation center? 25 MS. CARULAS: Objection. 0027 1 A. I'm not sure. I don't remember. 2 BY MR. KULWICKI: 3 Q. Do you know if The Cleveland Clinic was 4 in any kind of research, consulting or other type of 5 agreement with Biosense Webster? 6 MS. CARULAS: Objection. 7 A. Well, we have protocols, you know, like 8 the one that you mentioned -- 9 BY MR. KULWICKI: 10 Q. Did you say protocols? 11 A. Protocols like the one you mentioned, 12 NAVISTAR. So those require your -- an agreement 13 with The Cleveland Clinic. So I'm sure we had, you 14 know, but I'm not -- I don't remember exactly. 15 Q. Would you have been a signatory on 16 behalf of The Cleveland Clinic -- 17 A. No. 18 Q. -- to those? 19 A. No. 20 Q. What were the relative risks of 21 minimally invasive MAZE procedures for treatment of 22 persistent atrial fibrillation versus the risks 23 posed by radiofrequency ablation, PVAI ablation? 24 A. You know, there is no study to compare 25 the two. In general it is a more invasive procedure 0028 1 than catheter ablation so we expect morbidity from 2 that. 3 Q. More bleeding? 4 A. Morbidity. Morbidity. More chances of 5 problems. 6 Q. Okay. 7 A. Morbidity. 8 Q. Morbidity. And what aspect of it is 9 more invasive? It's not an open procedure, right? 10 A. Yeah, but you have to actually invade 11 the chest, so it is more invasive. You have to 12 actually make incision and invade the chest on both 13 sides of the chest. 14 Q. But with respect to the radiofrequency 15 ablation, you have to invade the groin, true? 16 A. It is just needle poking. There's no 17 incision. 18 Q. Besides the relative invasiveness of the 19 procedure, are there any increased risks associated 20 with the MAZE -- the minimally invasive MAZE 21 procedure? 22 A. You know, as I said, there is no 23 head-to-head comparative study, but based on the 24 technique that is used, we expected the risk would 25 be higher. 0029 1 Q. Was Dr. Gillinov doing the minimally 2 invasive MAZE back in 2006? 3 A. They were, yes. 4 Q. And were there other docs doing that 5 procedure? 6 A. I'm not sure. I'm sure that there are 7 others, but probably was the main person involved 8 with that. 9 Q. Would Mr. Sullivan have been a candidate 10 for minimally invasive MAZE? 11 MS. CARULAS: Objection. 12 A. Anybody can be a candidate. It's a 13 matter of preference, you know, of the patient and 14 the relative expertise of the center. There is no 15 mutual exclusive -- inclusive criteria. You know, 16 those are things that I discuss with the patient and 17 then they make a decision. 18 BY MR. KULWICKI: 19 Q. What were the success rates back in 2006 20 of the minimally invasive MAZE procedure for 21 persistent afib? 22 A. You know, I -- off the top of my head I 23 don't remember. 24 Q. Do you know what they are today? 25 A. No. 0030 1 Q. When you're advising a patient about 2 risks and benefits of -- and alternatives of 3 radiofrequency ablation, don't you think it's 4 important to be able to cite to them what the 5 alternatives are and what the risks and benefits are 6 of the alternatives such as minimally invasive -- 7 A. We usually -- 8 MS. CARULAS: Objection. 9 A. Yeah, we do. But usually the patient 10 that we see they come already with -- you know, made 11 up their mind they want a catheter ablation 12 procedure. They don't come -- 13 THE REPORTER: Stop. 14 THE WITNESS: Yes. 15 THE REPORTER: I need you to back up 16 completely. I cannot understand that. 17 A. So usually when a patient comes to us 18 they come because they already made a decision that 19 they want a catheter ablation procedure. They don't 20 come because they want to hear about surgical 21 versus -- they come because they made up their mind 22 because they want a catheter-based procedure. 23 Q. Was there any effort by The Cleveland 24 Clinic back in 2006, to your knowledge, to try to 25 educate patients before they came to The Cleveland 0031 1 Clinic for atrial fibrillation ablation procedures? 2 MS. CARULAS: Objection. 3 A. I'm not sure what you mean with that. 4 Beyond the website, I'm not aware of, you know, any 5 specific attempt. 6 BY MR. KULWICKI: 7 Q. And in terms of the way a procedure was 8 organized where a patient would come in for -- what 9 did you call it? A one-visit -- a one-visit 10 procedure where they would come in and meet the 11 physician and then get the procedure done all in 12 one -- the course of one visit to the clinic, is 13 that what they call it, one visit? 14 A. It depends. Honestly I'm not sure. I 15 actually used to see my patient sometimes even a 16 year before their procedure and then we see them 17 again the day before, so it depends. We try to 18 facilitate people coming from far away, but it 19 doesn't mean that that's the way it's done 20 necessarily all the time. 21 Q. So let's talk about that scenario where 22 a patient comes from out of town and they would come 23 in and they would meet their physician for the first 24 time and then have the procedure done either that 25 day or the next day all as part of the same visit, 0032 1 one visit. That was something that you were aware 2 was happening at The Cleveland Clinic back in 2006, 3 right? 4 A. It was based on patient preference. You 5 know, it's not something that we necessarily 6 encouraged. It was something that the patient 7 sometimes asked and we tried to arrange it. And 8 usually when we did that, it's because they already 9 had a very clear idea of what they wanted, so it was 10 more -- have to make sure there was no other issue 11 that we need to take care of and, you know, meeting 12 the physician that was going to do the procedure. 13 But most of the time this was done that way, meaning 14 meeting the patient the day before the procedure, 15 the day after is because the patient already had 16 very clear idea what they wanted to do. 17 Q. Well, that's what I want to talk about 18 is patient having a very clear idea. One place they 19 could get information to get a very clear idea about 20 whether they want atrial fibrillation ablation 21 versus -- versus say a minimally invasive MAZE 22 procedure would be The Cleveland Clinic website, 23 true? 24 A. That could be one. It could be their 25 referring doctor. They could have doctor locally. 0033 1 There are several -- you know, there are websites 2 for patients to -- so there are several tools for 3 the patient. 4 Q. And in fairness, back in 2006 there 5 wasn't any generally accepted success rate or 6 complication rate for PVAI ablation for persistent 7 atrial fibrillation, true? 8 A. No, there were, you know, based on what 9 was published in the literature. 10 Q. Well, isn't it true that in fact doctors 11 today haven't yet figured out what is the optimal 12 way to perform an ablation procedure on a patient 13 with persistent atrial fibrillation? 14 MS. CARULAS: Objection. 15 Go ahead. 16 A. Not -- I think you're confusing 17 long-standing persistent with persistent. The 18 long-standing persistent there is a some 19 discrepancy, although the minimum is antrum 20 isolation. That's something I think we established 21 that is important to everybody. The adjunctive 22 lesion are -- but is not specific to this patient. 23 This is for longstanding persistent. 24 BY MR. KULWICKI: 25 Q. Now, back in 2006 the FDA had not 0034 1 approved any device for ablation of persistent 2 atrial fibrillation, true? 3 A. Even for paroxysmal. 4 Q. Yes. For either/or, right? 5 A. Either/or, yeah. 6 Q. And, in fact, isn't the SARA, the 7 S-A-R-A, Study -- are you familiar with that? 8 A. No. SARA? 9 Q. This would be the study out of Barcelona 10 where they're trying to determine the safety and 11 effectiveness of PVAI for persistent afib, and 12 that's just starting now. Are you familiar with 13 that? 14 A. There are several studies in all the 15 United States. That's not the only one. 16 Q. So its -- its safety and 17 effectiveness -- in other words, the ablation of 18 patients with persistent afib, the safety and 19 effectiveness of procedures for that condition is 20 just being studied now; is that true? 21 A. No. 22 Q. You disagree with that? 23 A. There are several studies, yes. There 24 are several studies they have been done already. 25 There are several others that's ongoing. So that's 0035 1 just one study that you mentioned that is ongoing 2 now of several. 3 Q. Okay. And what had been completed as of 4 2006? What studies? 5 A. There are several publications. I think 6 you can find them in the literature on persistent AF 7 operation. 8 Q. Can you name any? 9 A. From US, several from US, from Europe. 10 They're all in PubMed. 11 Q. Was The Cleveland Clinic involved in any 12 of those studies? 13 A. We were. This was one of the database 14 to track results, so we are at least tracking our 15 results. 16 Q. And -- 17 A. And we were involved in some studies, 18 mostly in Europe. 19 Q. Did The Cleveland Clinic publish any 20 results of its use of PVAI to treat persistent afib, 21 to your knowledge? 22 A. Yes, we did. 23 Q. And where were those results published 24 at? 25 A. Different journals, HeartRhythm Journal, 0036 1 Circulation. I really can't cite all the 2 publications. 3 Q. And do you know who would be the lead 4 author on any of those articles? 5 A. Different people. 6 Q. You know, I don't want to be coy, but I 7 just was kind of hoping to get some information 8 here. Can you name one or any -- people who -- you 9 know, any of these articles? Can you identify any 10 of them where The Cleveland Clinic published its 11 experience with PVAI ablation for persistent afib? 12 MS. CARULAS: You can note an 13 objection. Obviously there are many, many, many 14 articles and you're asking for a specific period in 15 time. That's not a fair question. 16 MR. KULWICKI: I'm just asking for 17 one. 18 MS. CARULAS: Well, it -- and then 19 you'll -- you know, you'll cross-examine him because 20 he got the date off. So I mean it's just not an 21 appropriate question at this point. 22 A. You can find them in PubMed. You can go 23 to PubMed and check their system. 24 BY MR. KULWICKI: 25 Q. Well, I have and I haven't found any. 0037 1 A. Then you've not checked because there 2 are several. 3 Q. Well, it would be nice if you could name 4 one. If you could name maybe an author who has -- 5 from the clinic who has published on the clinic's 6 experience. 7 MS. CARULAS: Objection. 8 You don't have to guess as to dates 9 and -- 10 A. Honestly I don't remember. 11 BY MR. KULWICKI: 12 Q. Now, were there any studies at the 13 clinic with respect to the robotic technology for 14 doing atrial fibrillation ablation? 15 A. No specific -- 16 MS. CARULAS: Objection. 17 A. No specific study. Just the same things 18 I mentioned before. Everything was part of a 19 database. We just follow the outcome, but looking 20 at the database. 21 BY MR. KULWICKI: 22 Q. Currently here at Texas, just to give me 23 some idea about the usefulness of robotic versus 24 manual ablation procedures, are you doing them 25 robotically here? 0038 1 MS. CARULAS: Note an objection. 2 Go ahead. 3 A. There are physicians that like robotic 4 and others don't. Part of it is access. You know, 5 we have robotic in some of the rooms, not all the 6 rooms. But there are physicians that like it and 7 others that don't. 8 BY MR. KULWICKI: 9 Q. Is there any variance in the success 10 rate between robotic and manual procedures? 11 MS. CARULAS: Objection. 12 Go ahead. 13 A. No, no major difference. 14 BY MR. KULWICKI: 15 Q. In Mr. Sullivan's records it was 16 difficult to tell that robotics were used and it's 17 my understanding from -- 18 A. It was not. 19 Q. I'm sorry? 20 A. It was not. 21 Q. It was not difficult? 22 A. No, it was not used for the main 23 ablation on the left side. It was used only on the 24 right side. 25 Q. On the right side. 0039 1 A. And it was not robotic. It was, you 2 know, magnetic. You know, robotic is a general term 3 that doesn't apply to every system. 4 Q. So remote ablation was used for the SVC 5 ablation -- 6 A. Yes. 7 Q. -- in this case, right? And it's not 8 specifically stated in his op note that robotic -- 9 that remote technology was used for that procedure. 10 Was that something that -- when you trained 11 Dr. Burkhardt that you would have trained him to do; 12 in other words, to not include that information in 13 his op note? 14 MS. CARULAS: Objection. 15 A. No. 16 BY MR. KULWICKI: 17 Q. Was that a policy at The Cleveland 18 Clinic to keep that information out of op notes 19 with -- 20 A. No -- 21 Q. -- respect to -- 22 A. -- absolutely not. 23 Q. Okay. Was that something -- 24 MS. CARULAS: Just note an 25 objection. 0040 1 BY MR. KULWICKI: 2 Q. -- that you would include in your op 3 note if you went -- 4 A. He -- actually in the report you can 5 tell that the procedure was done with an open 6 irrigation catheter. So that's something -- 7 THE REPORTER: Back up. With a 8 what? 9 THE WITNESS: An open irrigation 10 catheter. 11 A. Which is not available -- which was not 12 available at the time with the magnetic. So you can 13 tell. 14 BY MR. KULWICKI: 15 Q. Understood. But the left side was done 16 with the -- 17 A. The procedure was done and not with an 18 open irrigation. 19 Q. Right. But the right side was done with 20 a magnetic tip catheter and that's not discussed in 21 the op note, right? 22 A. It is in the record, I think. It is in 23 the record. 24 Q. In what record? 25 A. The procedure record, I think. Even in 0041 1 the -- in some of the paperwork you showed me 2 before, it's like -- it mentioned cath RMT. Cath 3 RMT is the magnetic irrigation, so you mentioned 4 that. It is not a secret, I think. 5 Q. With respect to PVAI ablation back in 6 2006 at the clinic for persistent afib, can we agree 7 that it's not likely to be successful with just one 8 surgery; in other words, patients more often than 9 not need more than one surgery to make it a 10 successful procedure? 11 A. No, I would say 60 percent or slightly 12 more than that can be successful we want to see. So 13 it is not too generally. 14 Q. Let's talk about the risk of stroke with 15 minimally invasive MAZE procedures. Is there a risk 16 of stroke associated with that procedure? 17 A. Less likely because the lesions are 18 deployed epicardially, yes. 19 MS. CARULAS: Employed epicardially? 20 Is that -- 21 THE WITNESS: Deployed epicardially, 22 yes. 23 BY MR. KULWICKI: 24 Q. In terms of training Dr. Burkhardt, your 25 involvement as training him, would you have -- would 0042 1 you have trained him to -- when it comes to advising 2 a patient about a procedure, how a procedure is 3 done, if it was going to be done remotely or 4 manually, would that be something that you would 5 have trained him to talk to the patient about? In 6 other words, when you're describing the procedure to 7 talk about how it would be done, specifically saying 8 we're going to be using some remote technology or 9 we're going to be doing this manually? 10 MS. CARULAS: Objection. 11 A. You know, there are things that you 12 do -- the way you navigate the catheter is not 13 necessarily -- unless the patient specifically asks 14 is not necessarily relevant. There are things that 15 sometimes change during the procedure, you make 16 decisions based on what happens. So in general, 17 yes, we discuss the plan, the treatment plan. But, 18 you know, in terms of tool, it's not like you're 19 committing to a tool. You know, during the 20 procedure you -- what you need to do for the patient 21 is sometimes you change the tool that you use. 22 (Deposition Exhibit No. 4 marked.) 23 BY MR. KULWICKI: 24 Q. Now, I'm going to hand you what I'll 25 mark as Deposition Exhibit 4 which is a copy of -- 0043 1 well, you tell me. I think what this is -- it's a 2 ten-page document. It looks to be the IRB approved 3 written consent form for the NAVISTAR study that we 4 talked about earlier. Is that what I said it is? 5 MS. CARULAS: I'm going to have a 6 continuing line of objection to this, but go ahead. 7 MR. KULWICKI: That's fine. 8 A. Probably this is not informed consent, 9 but this is the protocol -- the protocol that 10 somebody took to the IRB, yeah. 11 BY MR. KULWICKI: 12 Q. So let me understand that. 13 A. Actually -- yeah, it is informed 14 consent. 15 Q. Okay. Would the patient who was 16 enrolled in the study sign something in addition to 17 the informed consent? 18 A. No. 19 Q. Now, one of the things that I was 20 interested in in this, and I'll hand this to you if 21 you want to see it, it says, "The radiofrequency 22 catheter used in the study -- in this study for the 23 ablation procedure is investigational which means it 24 has not been approved by the FDA for the treatment 25 of atrial fibrillation." And that's correct, right? 0044 1 You would agree with that? 2 A. Specific to atrial fibrillation, yes. 3 Q. And if -- in the terms of Mr. Sullivan, 4 he had the CELSIUS THERMOCOOL. That's pretty much a 5 very similar catheter to the NAVISTAR THERMOCOOL, 6 true? 7 A. The concept is similar, yes, open 8 irrigation. 9 Q. I mean, in terms of risks, benefits or 10 effectiveness and safety, they're pretty much the 11 same thing? 12 A. They should be the same, yes. 13 Q. All right. And this thing goes on to 14 say that -- it talks about afib and it says it's 15 "usually not a life threatening condition." Would 16 you agree with that? 17 A. No, I don't. 18 Q. You think it's a life-threatening 19 condition? 20 A. It is a life-threatening condition. 21 Q. Now, when it's a -- when a patient has a 22 CHADS2 score of zero, is it -- in terms of the risk 23 of stroke, is their risk of stroke greater with 24 catheter ablation or without catheter ablation? 25 MS. CARULAS: Objection. 0045 1 A. Slightly higher without catheter 2 ablation. 3 BY MR. KULWICKI: 4 Q. Okay. What do you understand to be the 5 risk of stroke -- lifetime risk of stroke in a 6 patient with a CHADS2 of zero? 7 A. It's about 1, 2 percent per year. 8 Q. Isn't it true that a patient with a 9 CHADS2 of zero, the risk of stroke is so low that 10 they're not even required to be on anticoagulation? 11 A. No, it is not true. You -- I think 12 you're confusing the results. The risk of 13 complication from Coumadin can outweigh to the 14 benefit. It doesn't mean that there is a stroke. 15 Stroke is zero. In fact, we're encouraging patients 16 to be on Coumadin even if they CHADS score was zero 17 because their risk of stroke is higher than zero. 18 And those are probably people usually younger that 19 probably -- you know, they would benefit more from 20 not having stroke. So it's not true what you're 21 saying. 22 The issue is that the risk of 23 bleeding with Coumadin can sort of outweigh the 24 benefit of the Coumadin therapy. In some way many 25 of the study looking at prevention of stroke they 0046 1 have a smaller number of patient which is called 2 zero. So, you know, some of the -- those 3 conclusions might be biased by that. But in general 4 we actually see a lot of patients with a CHAD score 5 of zero that come with reduced risk of stroke, so 6 absolutely it's the wrong idea that people have -- 7 that CHAD score zero means no stroke. It doesn't. 8 Q. But you would agree that a CHADS2 of 9 zero, that it would be certainly a reasonable 10 judgment call of a physician to not anticoagulate 11 that patient? 12 A. It is acceptable, yes. 13 Q. This Deposition Exhibit 4, the IRB 14 approved informed concept form for the NAVISTAR 15 THERMOCOOL study, it says that "Medications have 16 been the standard treatment for afib." Would you 17 agree with that? 18 A. They would be considered. 19 Q. And it says, "Sometimes a second or 20 third medication does work" for those patients who 21 fail their first attempt at medical therapy. Would 22 you agree with that? 23 A. Yes. 24 Q. What is the likelihood of a second or 25 third medication working for a patient who fails 0047 1 therapy -- medical therapy on the first medicine? 2 A. It can range from 6 to no more than 20 3 percent. So very small. 4 Q. Now, this form states that the technical 5 name of the procedure is pulmonary vein isolation, 6 and I want to ask you about that. I've seen 7 different definitions. And was in fact -- the 8 procedure that you performed at the clinic pursuant 9 to this informed consent form, was it in fact 10 pulmonary vein antrum isolation? 11 A. Yes. 12 Q. And this form says that "Using standard 13 catheters the size of burns produced by the 14 electrical energy may be inadequate to successfully 15 cure patients of paroxysmal atrial fibrillation," 16 and I want to ask you about that. 17 So they're making a distinction in 18 here between standard catheters and the THERMOCOOL 19 catheter, right? 20 A. Yes. 21 Q. And the standard catheter would be one 22 that doesn't have the irrigated tip, true? 23 A. Yes. 24 Q. And those standard catheters, there's 25 two different sizes. There's the 4 millimeter and 0048 1 the 8 millimeter, true? 2 A. There is a 10 also. 3 Q. And at the time this procedure was done 4 in 2006, were you using -- in those cases where you 5 weren't using an irrigated tip catheter, were you 6 using the 4 millimeter or the 8 millimeter? 7 A. We were using the irrigation for 8 everybody. 9 Q. Okay. 10 A. We were using the irrigation for 11 everybody. 12 Q. Irrigation. Now, in terms of inventory 13 management, when you're part of a study and 14 you're -- you know, you're an investigator for a 15 study, are there study catheters that are designated 16 as study catheters? 17 A. Yes. 18 Q. And how are those different from the 19 ones that are being used in off-label uses like in 20 Mr. Sullivan's case? 21 MS. CARULAS: This is a continued 22 line of -- 23 A. They're just -- they're just kept in two 24 different locations, so the research people, they 25 keep the catheter for use. 0049 1 BY MR. KULWICKI: 2 Q. Would the research catheters be any 3 different in terms of their design or manufacture 4 than the ones that were used for off-label purposes? 5 A. Not necessarily. It all depends. 6 Q. Were there any restrictions at The 7 Cleveland Clinic in using research catheters for 8 off-label uses that weren't part of studies? 9 A. I'm not sure what you're -- what you 10 mean. 11 Q. Sure. So we've got a situation here 12 where these catheters are part of a research -- are 13 being used as part of a research study, there's 14 catheters that are identified for research purposes. 15 Did the clinic have any rules or regulations, 16 policies, procedures, guidelines, protocols, any 17 other rules that would have placed restrictions on 18 the use of catheters that were part of a study for 19 uses that were not part of the study like in this 20 case, an off-label use to treat a patient? 21 MS. CARULAS: Objection. 22 A. This catheter was approved for ablation 23 already. 24 BY MR. KULWICKI: 25 Q. By who? 0050 1 A. By the FDA. 2 Q. Oh, for different -- for v-tach and 3 maybe flutter? 4 A. It was used for ablation. So when 5 that -- in that situation physician can use what is 6 best for their patient. 7 Q. And when we talk about what it was 8 approved for, it was v-tach, treatment of v-tach -- 9 A. Aflutter, yeah. 10 Q. -- and aflutter? 11 A. Yeah. 12 Q. Are those less technically -- less 13 technically demanding procedures than for persistent 14 afib? 15 A. No, actually v-tach is maybe even more. 16 Q. Does it involve puncture of the septum 17 and access to the left side of the heart? 18 A. For v-tach sometimes, yes. 19 Q. So what would be the difference in terms 20 of using this for treatment of afib as opposed to 21 v-tach? 22 A. There is no difference. In fact, you 23 know, this is exclusively a marketing reason the 24 cost of care more dollars because the company has to 25 pay money for a study like this. Because once a 0051 1 catheter approved for ablation, the cardiac tissues 2 are the same, the upper chamber and the lower 3 chamber. So it is exclusively a marketing -- for 4 marketing reasons companies spend money to do that 5 so they can talk about defibrillation. 6 Q. So when this was approved for v-tach and 7 aflutter prior to being approved for treatment of 8 paroxysmal afib, physicians thought, well, this 9 could be used for treatment of persistent afib and 10 they started using it for that purpose before it was 11 approved for that purpose, right? 12 A. Yeah. The catheter has been available 13 in Europe for seven years before it came to the 14 States. So there was plenty of experience around 15 the world. And, in fact, it was the standard of 16 care outside United States for many, many years 17 recognizing it was the best technology for ablation. 18 Q. Now -- 19 A. So we were behind. 20 Q. Okay. This -- this document goes on to 21 say that using standard catheters the size of the 22 burns might be inadequate to cure patients of 23 paroxysmal atrial fibrillation. It then says, "The 24 goal of this study, therefore, is to evaluate this 25 catheter for the ablation of paroxysmal atrial 0052 1 fibrillation to determine if it may increase the 2 chances of successful ablation." 3 And was that in fact the goal of the 4 study? 5 MS. CARULAS: The same continuing 6 objection. 7 Go ahead. 8 A. Well, it's complete -- specifically 9 that's relevant in comparison to drugs because there 10 is no other device. So it's -- you measure the 11 efficacy of ablation in comparison to drugs in 12 preventing recurring atrial fibrillation. That's 13 the objective. 14 BY MR. KULWICKI: 15 Q. But this goes on to say, "Larger burns 16 may result in a higher success rate for preventing 17 paroxysmal atrial fibrillation." 18 A. In general for an ablation. We know 19 that for many ablation we need to make a correlation 20 to a permanent effect so the catheter can achieve 21 that. There's a better chance of curing problems. 22 Q. But when I read this, Doctor, and what 23 I'm getting at here and what I want to ask you is, 24 is it seems like part of this study was to figure 25 out that if you use the irrigated tip catheter, if 0053 1 maybe you can create bigger lesions and maybe have 2 greater success, but that wasn't really known for 3 sure. 4 A. No, it was known. That's why they are 5 saying that. And actually the study didn't show 6 that because we have no way in a patient to look at 7 the size of the lesion. You have to kill the 8 patient to do that which we didn't intend to do. So 9 the objective of the study was to compare the 10 efficacy of catheter ablation with that specific 11 device in comparison to second drugs in preventing 12 recurrence of atrial fibrillation. 13 Q. So when it says the goal of this 14 study -- it says, "The goal of this study is to 15 evaluate this catheter for the ablation of 16 paroxysmal atrial fibrillation to determine if it 17 may increase the chances of successful ablation." 18 You say that's not really what the goal of it was. 19 A. In comparison to drugs. 20 Q. All right. Now, in terms of how the 21 procedure was done back in 2006, the process for 22 patients prior to the procedure, a couple of things 23 would be done. For instance, you would get lab work 24 to test their INR; isn't that true? 25 A. What is a standard for every patient 0054 1 atrial fibrillation? 2 Q. Right. In addition you would do -- 3 well, I'm talking about atrial fibrillation 4 patients. Let's talk about that. I don't really 5 care about anything else. So for atrial 6 fibrillation patients, one thing that you would do 7 before the procedure would be to check their INR, 8 true? 9 A. That's one of the tests, yes. 10 Q. And another thing would be to do a TEE 11 or some other kind of study to check for -- 12 A. Or a CT. 13 Q. Or a CT. -- to check for clots in the 14 left ventricle, right? 15 A. Yes. 16 Q. And in terms of those studies, was there 17 a timing element to them? In other words, was there 18 a certain time before you would operate on a 19 patient, do an ablation procedure, that you would 20 want to have that data in front of you? 21 MS. CARULAS: Note an objection. 22 Go ahead. 23 A. The INR is not really relevant. 24 Actually, in fact, more centers even today stop the 25 Coumadin. So the INR is more sort of standard lab 0055 1 that we obtain, but doesn't mean that that's going 2 to make -- sort of drive the decision if the 3 procedure is going to be done or not. Actually most 4 of the lab I would say still today stop Coumadin 5 before the procedure. The CT scan or TEE is 48 6 hours. 7 BY MR. KULWICKI: 8 Q. 48 hours. Now, with respect to the INR, 9 I know back in 2006 they asked for an INR on 10 Mr. Sullivan, right? 11 A. Yeah. 12 Q. And let's say that they wanted to assess 13 the INR before a procedure. What would be the time 14 frame that they would want to assess it? Is it -- 15 A. There is no -- there is no -- you know, 16 it could be a week. There's no really time frame. 17 As I said, many centers have stop Coumadin so the 18 INR becomes irrelevant. 19 Q. Now, back in 2006 in terms of the INR -- 20 in terms of anticoagulation for the procedure, it's 21 my understanding that during the procedure the 22 patient would be heparinized, correct? 23 A. Yes. 24 Q. And then at the conclusion of the 25 procedure, the Heparin would be partially reversed, 0056 1 true? 2 A. Yes. 3 Q. And that no additional Heparin would be 4 infused during the immediate post-op period, true? 5 A. Usually the protocol in many of the 6 centers to resume some type of anticoagulation 7 within six to eight hours. 8 Q. And during that six or eight hours the 9 level of Heparin in the person's blood; in other 10 words, the degree of anticoagulation afforded by the 11 intraoperative Heparin that was given, would 12 gradually sort of wear off, true? 13 A. It could, sure. 14 Q. And also in addition to the Heparin 15 that's sort of wearing off and being reversed, 16 patient would be given four baby aspirin right after 17 the procedure, true? 18 A. A full dose of aspirin. 19 Q. Say again. 20 A. Right at the end of the procedure. 21 Q. Yeah. And how long does it take for 22 that baby aspirin to work? 23 A. Probably 40 minutes. 24 Q. And how long does it last for? 25 A. Seven days. 0057 1 Q. And what sort of benefit does that 2 confer? Is there any way you can quantitate the 3 benefit conferred by aspirin? 4 A. No. 5 Q. So if a patient isn't on Coumadin prior 6 to the procedure, doesn't have a therapeutic INR 7 prior to the procedure, then during that six- to 8 eight-hour period after the procedure they've got 9 Heparin that's wearing off, they've got baby aspirin 10 on board, but they wouldn't have the benefits of any 11 Coumadin to anticoagulate them and protect them 12 against the risk of stroke during that six- or 13 eight-hour period, true? Is that correct? 14 A. They would not be fully protected, no. 15 But this is a standard procedure. This is what 16 every lab does. 17 Q. Right. So there's two different ways 18 you can do the procedure, right, one is with a 19 therapeutic INR and one is without therapeutic INR? 20 A. With the therapeutic INR is something 21 that we started and is not being embraced -- is not 22 being embraced as a standard procedure. So it's 23 something that actually we proposed to the medical 24 community, but is not standard of care. Standard of 25 care is still stopping the Coumadin and after the 0058 1 procedure you resume Lovenox or Heparin within six 2 to eight hours. 3 Q. But in point of fact, Doctor, after this 4 procedure the patient would be at an increased risk 5 of stroke during the six- to eight-hour period after 6 the procedure if they don't have a therapeutic INR, 7 true? 8 A. It is theoretically. It's not really a 9 factor, you know, based on data. Actually, in fact, 10 most of the stroke happen during the procedure, not 11 after. 12 Q. Well, in fact, the -- 13 A. There are people that afib that stop 14 Coumadin because they need to have surgery for a 15 week. It is done because the risk is relatively 16 small unless they had previous incidents where they 17 have a stroke by stopping Coumadin, you know, for 18 one or two days. But this is sort of standard 19 procedure in medical care with patient with afib. 20 The risk of stroke is not an impending risk of 21 stroke. It is a statistical risk of stroke. It 22 doesn't mean it's going to happen the moment you 23 stop the Coumadin. So it's standard procedure to do 24 that not just for an ablation but for any type of 25 surgical procedure that a patient for whom there is 0059 1 a fibrillation need. 2 Q. You know the Patel article where he 3 published The Cleveland Clinic's results and talked 4 about -- and you were a coauthor on that article 5 where he looked back or -- 6 A. It is she. 7 Q. She? 8 A. Yeah. 9 Q. Those physicians, whoever they were, 10 they looked back over The Cleveland Clinic's 11 experience and they found that there were something 12 like 26 strokes. 13 A. But this is strokes including the one 14 from here from Austin. Probably there is some 15 inconsistency in that paper. The one from the 16 clinic I think there are less than 20. 17 Q. Okay. As I read that paper -- where was 18 the data from that paper gotten from? Was it from 19 the research database? 20 A. On the -- 21 MS. CARULAS: I just have a 22 continuing line of objection to this. 23 But go ahead. 24 BY MR. KULWICKI: 25 Q. Do you know? 0060 1 A. From the -- that's the source of our -- 2 the source of information. 3 Q. Now, when I went through that article, 4 there was no mention of Mr. Sullivan's stroke in 5 that article. It's not included in -- 6 A. It is not included, yeah, because the 7 data stopped -- the data they pulled was stopped in 8 June 2006. And then there was a year follow-up 9 added to that to look at the neurologic function 10 after the stroke. 11 Q. Now, all the patients that had strokes 12 in that study, none of them had therapeutic INRs -- 13 A. None of them. 14 Q. -- correct? 15 A. Yeah, probably so. That's probably true 16 because they start later. 17 Q. And is it your contention that that had 18 no bearing on the fact that they had strokes or do 19 you think that was a factor? 20 MS. CARULAS: Objection. 21 A. I'm not sure what you say. 22 BY MR. KULWICKI: 23 Q. A subtherapeutic INR being a factor in 24 the strokes that are reported in Patel's article. 25 MS. CARULAS: Note an objection. 0061 1 Go ahead. 2 A. Actually, no. The risk of stroke was 3 relatively lower than many other centers. The risk 4 of stroke with this procedure goes up to 4 percent 5 and our risk of stroke on average was below 6 1 percent. 7 BY MR. KULWICKI: 8 Q. After this stroke occurred, did you 9 undertake any efforts to try to understand why it 10 happened? 11 MS. CARULAS: Objection. 12 A. No. Actually we -- we started doing the 13 therapeutic Coumadin not to prevent stroke but to 14 prevent measured bleeding with Lovenox. So there's 15 no -- you know, a stroke is a complication that 16 happens when you put catheter in people's bodies 17 that are not supposed to be there. So that sort 18 of -- it is an accepted. Then we realized recently 19 that therapeutic Coumadin might help with 20 periprocedural stroke, but the initial attempt was 21 driven by a higher risk of bleeding complication 22 with Heparin or Lovenox after. 23 BY MR. KULWICKI: 24 Q. In the patients at the clinic who had a 25 therapeutic INR before -- you know, before a 0062 1 procedure such that they would have a therapeutic 2 INR during the six- to eight-hour period after the 3 procedure, was the reason for doing that to minimize 4 the risk of stroke? 5 A. No. I just answered the question. The 6 reason was to reduce the risk of bleeding after the 7 procedure. 8 Q. But Coumadin would actually increase the 9 risk of bleeding, right? 10 A. No, actually you could use it as 11 compared to the standard of care, which is Lovenox 12 or Heparin. 13 Q. Understood. 14 A. Yeah. 15 Q. So -- but the -- it's still an 16 anticoagulation, and the purpose of anticoagulation 17 is to present -- prevent or minimize thrombogenic 18 events, right? 19 A. This is the way it is used, one of the 20 other ways that this is used in clinical practice, 21 yes. 22 Q. So -- and the purpose of Lovenox is to 23 minimize thrombogenic events, right? 24 A. The purpose of Lovenox is the same, yes. 25 Q. Right. Or thromboembolic events. So -- 0063 1 A. Yes. 2 Q. -- you would -- so you're saying that 3 Coumadin would minimize the risk of bleeding while 4 you're protecting against thromboembolic events over 5 Lovenox? 6 A. Lovenox, yes. 7 Q. Got it. Now -- actually I asked a 8 different question earlier and I apologize; I didn't 9 state it very clearly. After Mr. Sullivan's stroke, 10 did you come to any conclusions about why it 11 occurred? 12 MS. CARULAS: I'm going to note an 13 objection to obviously any discussion that would 14 have been protected under M&M and so forth. 15 So, I mean, independent of any type 16 of meeting of that form which you cannot discuss 17 here today, did you make any independent assessment 18 I guess is the question. 19 A. No. You know, as I said, I was 20 uninvolved. As I said before, it is one of the 21 complications that is part of this procedure, so 22 there was not anything unusual. 23 BY MR. KULWICKI: 24 Q. And in terms of the -- this is a 25 complication of the procedure. Aren't there two 0064 1 factors that increase the risk of stroke with 2 catheter ablation, one being cardioversion and the 3 other being the actual ablation itself? 4 A. Not necessarily -- the cardio ablation 5 not necessarily. Usually when it's done during the 6 procedure the patient is anticoagulated. So it's 7 really mostly in the catheter. 8 Q. But doesn't cardioversion increase the 9 risk of stroke in and of itself for patients for a 10 period of time after the cardioversion? In other 11 words, there are standards, aren't there, for 12 cardioversion that require the patient be 13 anticoagulated during the cardioversion but also 14 after the cardioversion, true? 15 A. This is for people that have been in 16 atrial fibrillation for, you know, several, several 17 days. 18 Q. Right. And -- 19 A. And off anticoagulation all the time. 20 If you sort of stop the anticoagulation for a few 21 hours, there is no data. 22 Q. Right. So -- 23 A. So these are people are that off 24 anticoagulation or cardioverted and the risk of 25 stroke can continue for a few weeks if they are not 0065 1 anticoagulated, but there is no data on patient that 2 they're off for, you know, three or four hours. 3 Q. But doesn't it stand to reason that 4 after a catheter ablation procedure where you're 5 actually burning in the left side of the heart and a 6 patient's at, you know, risk of char and coagulum 7 formation in the left side of the heart, the chamber 8 that empties into the distribution of where the 9 brain is at, won't it stand to reason that adding 10 cardiac lability from cardioversion to that mix -- 11 A. No. 12 Q. -- would increase the risk of stroke? 13 Doesn't make sense to you? 14 A. No, it doesn't make sense. There is no 15 data. That's what I'm saying. 16 Q. Well, no data, but does it make sense? 17 MS. CARULAS: Objection. 18 A. Not necessarily because there's 19 a short -- it's such a short period of time. It is 20 going to be difficult to -- in fact -- no. If you 21 look at -- you know, as I said before, if you look 22 at our stroke rate, it is much lower than many other 23 centers. So I would say it doesn't make sense that 24 that's really a critical factor. Otherwise, you 25 would see a lot, which we didn't. 0066 1 BY MR. KULWICKI: 2 Q. Let's break this down. So with 3 cardioversion -- after cardioversion there is a risk 4 of cardiac stunning, true? 5 A. Yes. 6 Q. And cardiac stunning can increase the -- 7 or increases the risk of stroke, true? 8 A. Yeah. But again, only if you have not 9 been anticoagulated for a long, long time. 10 Q. So the -- meaning, in other words, you 11 have a subtherapeutic INR for a long period of time, 12 right? 13 A. Yeah. 14 MS. CARULAS: Objection. 15 A. Yeah. Not for a few hours. It is 16 absolutely not in a few hours. 17 Q. And the reason why cardiac stunning 18 increases the risk of stroke after a cardioversion 19 is because it -- the heart doesn't pump as 20 effectively and therefore there's an increased risk 21 of stasis, right, which can increase the risk of 22 thrombus formation, true? 23 MS. CARULAS: Continuing line of 24 objection. 25 Go ahead. 0067 1 A. That is speculation and sort of hard to 2 justify that, but there is really no data to support 3 that. It is sort of what people think, yes. 4 BY MR. KULWICKI: 5 Q. Sure. And you would expect that after 6 cardioversion that the likelihood of stunning 7 leading to contractility issues and the like would 8 be greater immediately after the cardioversion as 9 opposed to a day later or two days later or three 10 weeks later. Would you agree? 11 A. It depends on the degree of AF before 12 and the time of unprotected. So it is not a general 13 statement you can make. 14 Q. But stunning after cardioversion is 15 greatest after the cardioversion has occurred and it 16 wears off over time, true? 17 A. The cardioversion -- so if you've been 18 in fibrillation less than 48 hours, you can 19 cardiovert and there is no increased risk of stroke. 20 So that's what I'm saying. It is not just the same 21 explanation like you're trying to make it sound. 22 It's something very complicated that has multiple 23 effect of planing in -- and, you know, in the 24 specific case of a patient in an ablation that does 25 not -- seems to be a problem. Otherwise, people 0068 1 would have done something over the year because, you 2 know, it would have become clear that that was a 3 practice that was dangerous and is not. In fact, 4 many centers actually the standard of practice do 5 the same, stopping Coumadin and then starting 6 Lovenox six to eight hours. 7 Q. Right. And it's your opinion that -- is 8 it your opinion that patients shouldn't have to be 9 told about that, that there's a choice between 10 having a therapeutic INR leading up to -- 11 A. When we didn't -- when the procedure was 12 done, we didn't know. 13 Q. We didn't know what? 14 A. That doing the procedure on therapeutic 15 INR is in protection. We actually didn't know. 16 Q. So going back to Mr. Sullivan's case 17 with a persistent -- let's forget about afib -- or 18 let's forget about atrial fibrillation ablation. 19 But with a persistent afib and a subtherapeutic INR 20 for a long period of time, if he was just going to 21 have a cardioversion, he would have to have had -- 22 to meet the standard of care, he would have had to 23 have had a therapeutic INR or therapeutic 24 anticoagulation during the cardioversion and 25 afterwards, true? 0069 1 MS. CARULAS: Note an objection. 2 A. No. During the coagulation not 3 necessarily, but after if the duration -- if it has 4 been more than 48 hours. 5 BY MR. KULWICKI: 6 Q. Okay. 7 THE VIDEOGRAPHER: Off the record at 8 9:11. 9 (Recess Taken From 9:11 a.m. To 10 9:24 a.m.) 11 THE VIDEOGRAPHER: We're back on the 12 record at 9:24. This is the beginning of tape 2. 13 BY MR. KULWICKI: 14 Q. Doctor, during the break I showed you a 15 couple of images on my computer and I want to ask 16 you about it. One of them was a CARTO image and 17 it's a single snapshot in time. And what I wanted 18 to ask you about that one was do you have any 19 knowledge or understanding of why that particular 20 picture would be one that would be kept as part of 21 Mr. Sullivan's records? 22 A. I am not sure, but that's -- what you 23 saw there is all the points that were attached to 24 with a catheter system -- catheter with a magnetic 25 irrigation system. So it's not a snapshot -- 0070 1 actually all the colored points that you see are all 2 the points that were attached with a specific cath, 3 so very few -- very few points. 4 Q. Okay. And then the other image that we 5 saw was actually a video clip of fluoroscopy, right? 6 A. A fluoroscopy, yes. 7 Q. And same question, do you know why that 8 portion of the procedure would have been kept? Is 9 there any reason that you can think of? 10 A. No. 11 Q. Now, that -- 12 MS. CARULAS: I just want to put an 13 objection in to why Dr. Burkhardt and his people 14 necessarily versus Dr. Natale are making that 15 judgment. 16 But go ahead. 17 BY MR. KULWICKI: 18 Q. Now, that image, the fluoroscopy shows 19 the remote navigation to do ablations in the right 20 side heart of the heart; is that correct? 21 A. This is right side, yes. 22 Q. The last thing I showed you, Doctor, was 23 a clip from a talk that you had given about remote 24 navigation and in it there was a discussion about 25 complication rates being higher at the clinic with 0071 1 respect to use of remote navigation, and you went on 2 in that clip to say that the reason why it was 3 higher was because of the fact that you-all used 4 fellows to do part of the procedure. Do you 5 remember that talk, by the way? 6 A. Well, it was one of several of many 7 talks I gave. So the issue is not part of the 8 procedure. It is access -- the majority of this 9 complication out of vascular complication has to do 10 with access. So that doesn't mean the procedure is 11 done by a fellow, it's just the access part which is 12 sort of standard of the clinic. The difference 13 between that system and the magnetic that was used 14 on Mr. Sullivan is that that system has a much 15 larger size catheter. So if your access is not 16 perfect, you increase the chances of vascular 17 complication. This is not an issue that we have 18 seen with the magnetic navigation, which is used -- 19 which uses the same size catheter that is used for 20 manual navigation. 21 Q. Is there a therapeutic reason why you 22 would do a procedure like it was done in this case, 23 doing the left side of the heart manually for the 24 PVAI and then doing the right side of the heart with 25 remote navigation? 0072 1 MS. CARULAS: Just note an 2 objection. 3 Go ahead. 4 A. Just a preference. At that time we were 5 doing ablation with a magnetic irrigation only in 6 the right side primarily because on the left we saw 7 that there was problems and so we stopped doing 8 that. So I guess that's the reason. The main 9 advantage for the operator is fluoroscopy exposure 10 and for the patient too because also the patient is 11 exposed to fluoroscopy. And the other advantage is 12 that the catheter is steadier with magnetic 13 navigation. You sort of -- the idea of this type of 14 technology is that you eliminate the experience of 15 the operator as one of the factors. 16 BY MR. KULWICKI: 17 Q. At the time back in -- this was August 18 of 2006 and you mentioned something that's reported 19 in -- Dr. DiBiase's the lead author on the article 20 about remote navigation. And in that article he 21 mentioned that something like 48 or 49 people had 22 had the remote catheter introduced to the left side 23 of their heart but not used for ablation as a way to 24 kind of get used to the technology. And then 25 subsequently there were efforts to actually use it 0073 1 for ablation purposes. 2 And my question is, is during this 3 time period, which is sort of between those two 4 events with Mr. Sullivan, would part of the reason 5 why it would be used on the right side of the heart 6 be to get some track record or experience in using 7 that technology? 8 A. No. 9 MS. CARULAS: Objection. 10 A. No. 11 BY MR. KULWICKI: 12 Q. All right. Is SVC ablation -- or was it 13 in 2006, were the benefits of it known or was it 14 more hypothetical at that point in time, 2006? 15 A. No, we actually had already data that 16 supported that. 17 Q. Now, there is a discussion about the use 18 of fellows, and I want to hand you what I'll mark as 19 Exhibit 5 which is the Fellowship Program 20 Supervision Policies. 21 (Deposition Exhibit No. 5 marked.) 22 BY MR. KULWICKI: 23 Q. Is this something, Doctor, that as -- 24 incidentally, that is a six-page document. Is this 25 something that you would have been involved in 0074 1 preparing in your position as co-director or co-head 2 of the afib area? 3 A. No. There was a fellowship co-director, 4 and actually I think Dr. Burkhardt was one of the 5 two fellowship directors at that time. 6 Q. And with respect to this, it says, 7 "Fellows are primarily responsible for assisting 8 their assigned staff and in patient care. There is 9 a progressive increase in autonomy for the fellows 10 throughout the 2 years. The first year fellows are 11 predominantly scheduled for cardiac device-related 12 cases, and the second year fellows are predominantly 13 scheduled for ablation cases." 14 Was that the case in 2006? 15 A. Predominantly means -- not necessarily. 16 Actually in 2006 because of the volume of ablation 17 probably, you know, whatever -- you know, whatever 18 fellow was available were involved in any of the 19 procedures. There was always a fellow in any 20 procedure. 21 Q. Right. And then it goes on to say here, 22 "Subsequently, the fellows perform progressively 23 more complex procedures, such as catheter ablation 24 procedures, though the staff is always present 25 during these procedures." And it says, "Except for 0075 1 minor procedures, the staff scrubs at least for the 2 crucial portion of the procedure. Even when 3 scrubbed, the staff allows the fellow to function as 4 the primary surgeon for as much of the procedure as 5 the fellow is capable of performing." 6 And was that your experience in 2006 7 at The Cleveland Clinic? 8 A. To a point, you know, then the -- you 9 know, a different attending, they can do whatever 10 they want. They can move around and watch. They 11 let people do -- 12 Q. Now, in terms of your training -- 13 A. Usually the access is something they do 14 because they're a cardiologist. By the time they 15 come to us, they're already trained cardiologists 16 and they've been doing access cardiac catheter. So 17 the access part is something that the referral does 18 independently. For the ablation part is a 19 progressive process with the attending side by side 20 and the degree of involvement to the fellow depends 21 on the fellow's skill, you know, the attending 22 comfort level, so they're different, yes. 23 Q. In terms of the learning curve for doing 24 catheter ablation procedures, specifically PVAI 25 ablation, do you have any standard that you would 0076 1 subscribe to in terms of what would be enough 2 procedures for somebody to be technically competent? 3 MS. CARULAS: Just note an 4 objection. 5 Go ahead. 6 A. There are guidelines from the Heart 7 Rhythm Society which is about 25 or 50 cases. So a 8 relatively small number. Probably something that a 9 fellow would be -- probably would be exposed in 10 maybe a month or even less than that. 11 BY MR. KULWICKI: 12 Q. And in terms of when a fellow does the 13 ablation part of the procedure, is that charted 14 anywhere at The Cleveland Clinic? Is there a record 15 kept of that? 16 A. No. 17 MS. CARULAS: Objection. 18 Go ahead. 19 A. No. Because this is an understanding -- 20 you know, patient knows this is a training program 21 and there will be a fellow involved. There are 22 patients that specifically require the attending to 23 do the procedure and in that case then obviously an 24 effort was made to that respect to honor the patient 25 wish. But in general people, you know, go to a 0077 1 center with a training program and a fellow be 2 involved. 3 BY MR. KULWICKI: 4 Q. And do you think that's something that's 5 important to communicate to the patient, that a 6 fellow may be performing their procedure? 7 A. They usually meet the fellow the day of 8 the procedure. 9 Q. And -- 10 A. The fellow actually introduce 11 themselves. 12 Q. Right. And in terms of experience, we 13 talked earlier, and you'd agree generally with the 14 principle, that a less experienced operator is going 15 to have a lower success rate -- 16 MS. CARULAS: Objection. 17 BY MR. KULWICKI: 18 Q. -- fair? 19 A. Yes. But, you know, I don't -- I don't 20 know if you can apply that to the fellow being 21 involved because the attending is always there. So 22 the involvement of the fellow is sort of driven by 23 what the fellow can do so that the attending always 24 stay covered. So you cannot quantify what that 25 means, you know, because you have an attending with 0078 1 experience taking over all the time. 2 Q. Now, it's my understanding that the way 3 this procedure is performed is that there are two 4 catheters that are used, one is the ablation 5 catheter and the other is the mapping catheter; is 6 that correct? 7 A. There is an echo catheter too, an echo 8 probe. 9 Q. What kind of catheter? 10 A. Echo probe. 11 Q. Is that -- 12 A. Inter -- no, no, it is an intracardiac 13 echo probe. 14 Q. And who mans the three catheters? Is 15 there one person does the ablation and the other 16 person does the other two catheters? 17 A. No. So the other two catheters really 18 they're all in place. So the person that assists 19 the operator just hold the other catheter. The echo 20 probe requires two or three movements that anybody 21 can do and then they stay there. 22 Q. Let me get that again. The echo probe 23 requires -- 24 A. It's an imaging tool, you know, that -- 25 just there to image the area that we are ablating 0079 1 and it doesn't require extensive manipulation. 2 Q. And the other probe -- the ablation 3 catheter obviously uses -- 4 A. Yes. 5 Q. -- it requires extensive manipulation? 6 A. This is what requires extensive 7 manipulation. The mapping catheter also can be 8 moved by the attending and then the other person 9 just hold it there. So really the ablation catheter 10 is the one that requires the most extensive 11 manipulation. 12 Q. Back at The Cleveland Clinic in 2006, I 13 think it's well established in this litigation, that 14 patients that were not in a study would not be 15 provided with a written informed consent form like 16 we have here marked as Deposition Exhibit 4, 17 correct? 18 A. Yes. 19 Q. And with respect to the risks of the 20 procedure, the material risks of the procedure would 21 be specifically listed in Exhibit 4; is that 22 correct? 23 MS. CARULAS: I'm sorry, can you say 24 it again? 25 MR. KULWICKI: Sure. 0080 1 BY MR. KULWICKI: 2 Q. I just want to ask if Exhibit 4 where it 3 talks about general risks, atrial fibrillation 4 ablation, these would be the material risks of the 5 procedure whether performed for paroxysmal or 6 persistent afib using a THERMOCOOL catheter, true? 7 A. Yes. 8 MS. CARULAS: I just want to put an 9 objection into that, this use of this document 10 again. 11 BY MR. KULWICKI: 12 Q. Now, Doctor, it says -- in here on 13 page 7, it says, "Due to the investigational nature 14 of the device for paroxysmal atrial fibrillation, 15 this study may involve risks that are totally 16 unforeseeable or unanticipated which could be 17 serious or even life threatening." 18 Would you agree with that? 19 A. Generally, yes. That is standard lingo 20 into any research protocol. 21 Q. And would you agree that that would 22 apply equally to the use of atrial fibrillation 23 ablation for persistent afib? 24 A. In general apply to any medical 25 procedure that is done. There is always something 0081 1 that you never saw in your life has never been 2 reported. 3 Q. Wisdom of -- well, strike that. 4 Now, after this procedure there was 5 an APTT -- 6 A. Yes. 7 Q. -- and forgive me, Doctor, but I can't 8 remember if that measures Heparin levels or -- 9 A. Heparin. 10 Q. Heparin. 11 A. It is not Heparin level. It is the 12 effect of Heparin. 13 Q. Fair enough. Would it measure the 14 effect of Coumadin levels at all? 15 A. No. 16 Q. I read or I was told at some point in 17 time that physicians who do this procedure like 18 yourself believe, based on monitoring with the ICE 19 monitoring and otherwise, that during the course of 20 a catheter ablation procedure that there are 21 literally thousands of micro clots that are thrown 22 off from the heart during the course of the 23 procedure. Do you subscribe to that belief as well? 24 A. No. 25 MS. CARULAS: Objection. 0082 1 A. No. There is -- one of the reasons why 2 we use intracardiac echo, and this applies only to 3 close -- nonirrigated catheter. So this statement 4 you make could be a possibility only with 5 nonirrigated catheter, not with irrigated catheter. 6 When you use a nonirrigated catheter, one of the 7 reasons why we try to encourage people to use 8 intracardiac echo imaging is to use that tool to 9 titrate power looking at micro bubbles. This is 10 something that doesn't apply to ordinary patients. 11 This is exclusively an issue with the catheters that 12 do not have open irrigation. 13 BY MR. KULWICKI: 14 Q. Now, when you talk about the open 15 irrigation, I read an article by Dr. Kanj where he 16 wrote, "Open irrigated catheters are associated with 17 tissue overheating and pops." Do you agree with 18 that or disagree? 19 A. Pops, yes. 20 Q. And what is a pop? 21 A. A pops is sort of a steam -- is a sort 22 of a small localized bubblization of the atrial 23 cell, or the ventricular cell depending on what 24 chamber you're ablating due to a deeper heating that 25 eventually cause, you know, sort of really steam 0083 1 upwardization -- a steam upwardization. It's almost 2 like a localized micro explosion. 3 Q. And it's my understanding that you can 4 actually hear these micro explosions outside of the 5 heart while you're doing the procedure. 6 A. You can, yes. 7 Q. It wasn't the policy of The Cleveland 8 Clinic to chart pops back in 2006, true? 9 A. No, nobody does. 10 Q. And yet pops increase the risk of 11 thromboembolism, true? 12 MS. CARULAS: Objection. 13 A. No, we do not. 14 BY MR. KULWICKI: 15 Q. Okay. 16 A. They can increase the risk of 17 perforation, but not thromboembolism. 18 Q. How about tissue overheating, can that 19 increase the risk of thromboembolism? 20 MS. CARULAS: Objection. 21 A. No, there is really no data. The only 22 data that we have is relative to known irrigated 23 catheter where we advocated the use of intracardiac 24 echo tool cardiac. Irrigation catheter is 25 absolutely not -- actually we didn't see any 0084 1 problem. One of the advantages of the irrigated 2 catheter is to prevent the charring because constant 3 char -- flush the tip of the catheter. 4 BY MR. KULWICKI: 5 Q. Right. Now, you talk about the lack of 6 data and, in fact, it's not even very well 7 understood today, is it, in terms of -- 8 A. No, no. 9 Q. Let me finish. 10 A. What I'm saying is -- 11 Q. Let me finish. I've got a different 12 question for you. 13 In terms of what causes stroke in 14 patients that are undergoing this procedure, it's 15 not very well understood even today why some 16 patients have stroke and others don't; isn't that 17 true? 18 A. In some -- in some respect, yes. You 19 know, obviously there is a predisposition of the 20 patient that factor in because we do -- you do the 21 same procedure on everybody. Some people develop 22 stroke where others don't. So certainly there is an 23 individual disposition which is true also for people 24 that have stroke without ablation. The feeling is 25 that those people have some sort of either 0085 1 endothelial or coagulopathy that could predispose 2 them to stroke. Otherwise everybody with atrial 3 fibrillation would have stroke, but they don't. 4 Same is true with ablation. 5 MR. KULWICKI: Objection, move to 6 strike. 7 BY MR. KULWICKI: 8 Q. But, Doctor, another factor with respect 9 to stroke formation is, for instance, you 10 appreciate, that operator experience -- 11 MS. CARULAS: Objection. 12 BY MR. KULWICKI: 13 Q. -- can increase the risk of stroke? 14 A. No. 15 Q. You disagree? 16 A. Yeah. 17 Q. How about -- 18 A. Where the operator is important is 19 really the success -- the part of the complication 20 where the operator can impact is mostly perforation 21 just because of the way they advance the catheter. 22 Determinable risk, there is no really evidence 23 that's true. 24 Q. Is there any data establishing 25 coagulopathy as the predominant factor in stroke 0086 1 formation in patients undergoing this procedure? 2 A. Not very strong, but this is what people 3 believe. 4 Q. Why is it, do you think, that the 5 success rate with paroxysmal is greater than with 6 persistent afib? 7 A. Again, this is depending on what you do, 8 but in general persistent afib needs more ablation. 9 So if you don't do it in the first place, they will 10 never be cured, and the more ablation you do, the 11 more chances you add that the effect of some of 12 those lesions is not permanent. So those are 13 usually what determine the success rate, the quality 14 of the lesion that you achieve. 15 Q. Are the risks of -- do you think that -- 16 again, recognizing there isn't any data, but do you 17 think that the more ablations that you do; in other 18 words, the more tissue that's burned, that the 19 greater the risk of coagulum or thromboembolism 20 formation? 21 MS. CARULAS: Objection. 22 A. You know, again, I don't think there is 23 any strong evidence of that. In general people with 24 chronic AF have a higher risk of stroke, which is 25 relatively small to start with mostly because they 0087 1 have just more stagnant blood to start with and 2 probably some -- again, some degree of coagulopathy. 3 If that was the only factor, since more ablation is 4 done in every patient with persistent or 5 paroxysmal/persistent, the risk of stroke would be 6 sort of prohibitive and we would not be doing this 7 procedure, which is not the case. 8 BY MR. KULWICKI: 9 Q. Now, with respect to the decision to 10 operate or not operate on a patient, is the final 11 authority vested in the attending physician and 12 staff who performs the surgery to decide whether or 13 not a patient should be a candidate for a procedure 14 or whether to scrap the procedure and not do it? 15 A. Yes. 16 Q. Okay. And with respect to that 17 decision -- strike that. 18 With a 10 percent complication rate, 19 would you call this procedure very safe? 20 A. It depends on what 10 percent means. If 21 there are vascular problems, then I would say that's 22 not a huge problem for the patient long term. So it 23 depends on what 10 percent means. So have to sort 24 of break them down in what is the percentage of the 25 complication that really can affect the patient long 0088 1 term. And, you know, the one that could stroke and 2 that actually is very, very small. 3 Q. Would you agree that when giving a 4 patient information about a medical procedure in 5 terms of the process of informed consent and 6 advising a patient about a procedure, would you 7 agree that in general, going back to you being 8 co-director or co-head of the atrial fibrillation 9 department at the clinic back in 2006, in general 10 statements given to a patient should be true? 11 MS. CARULAS: Objection. 12 A. I'm sorry, say again. 13 BY MR. KULWICKI: 14 Q. Talking about the process of informing a 15 patient -- 16 A. Yes. 17 Q. -- and getting their informed consent to 18 go forward with the procedure. Certainly in a 19 situation like this with persistent afib like 20 Mr. Sullivan, he had a couple of different options. 21 One is he could have gotten the minimally invasive 22 MAZE, another is he could have tried other 23 medications, a third would have been he could have 24 put off the procedure to wait until maybe it was a 25 little more better understood or better established 0089 1 as a procedure, correct? He had a number of 2 options, right? 3 MS. CARULAS: Objection. 4 A. This is true for paroxysmal for anybody. 5 BY MR. KULWICKI: 6 Q. Right. But I'm talking about 7 Mr. Sullivan. And as -- 8 A. There's nothing unique, you know, we -- 9 you know, that -- we were doing a thousand 10 procedures every year where probably half of the 11 patients were chronic. So there's nothing sort of 12 different. 13 Q. So with respect to a patient like this 14 who's making a decision whether to undergo this 15 procedure, would you agree that the information they 16 get should be accurate? 17 A. I'm sure they were. 18 MS. CARULAS: Objection. 19 A. Usually -- 20 BY MR. KULWICKI: 21 Q. That's not my question. Can we just 22 agree that the information they're given should be 23 accurate? 24 A. Yes. 25 Q. Okay. And that the information should 0090 1 be -- the accurate information about the risk, 2 benefits and alternatives for the procedure should 3 be given well enough in advance of the procedure 4 that the patient has time to sort of think through 5 their options and think through the risks and 6 benefits. Would you agree with that? 7 MS. CARULAS: Objection. 8 A. I'm not sure what you mean "long 9 enough." 10 BY MR. KULWICKI: 11 Q. Right. 12 A. As I said, the patient usually when they 13 come there, they already have a lot of information 14 from their local-caring physician. 15 Q. So you just assume that they were 16 already -- 17 A. When they come to hear the information, 18 to hear the risk, the benefit, the alternative 19 option and then they can make a decision right 20 there. And for the most patient -- for the most 21 part the patient already have decided before that 22 that's what they want. 23 Q. All right. And when they decide -- 24 A. Actually it was -- in general it was the 25 opposite. Whenever we didn't think it was 0091 1 appropriate, we had very hard time to convince the 2 patient not to do it because for the most part the 3 patient would come to us with already a very 4 specific idea in their mind of what they want, about 5 that they wanted. So it's not -- it is actually the 6 opposite for what you're saying. 7 Q. All right. So in terms of how The 8 Cleveland Clinic sort of -- and you as the head of 9 the afib department, your approach to informed 10 consent was just to assume that the patients already 11 knew all of the relevant information before they 12 arrived at the clinic -- 13 A. No. 14 Q. -- and therefore there wasn't any need 15 to really -- 16 A. No. 17 Q. -- educate them about -- 18 A. I didn't say that. We probably spend 19 more time than any other center. We have nurses 20 that spend more than an hour talking about the 21 risks, the benefit, and then we will spend another 22 30 to 40 minutes to go over the same issue and any 23 other questions. So we probably have a system where 24 we will spend more than the average center in 25 talking with a patient. So it's not true what you 0092 1 say. 2 Q. In a situation where the patient is 3 doing a one visit -- a one-visit procedure where 4 they come in and they have that meeting with the 5 nurse, they have the meeting with the physician, and 6 then they have the procedure all in a day or two 7 course of time, you don't know when that patient 8 arrives whether they have an appropriate 9 understanding of the risks, benefits or alternatives 10 to the procedure before they arrive at The Cleveland 11 Clinic, correct? 12 MS. CARULAS: Objection. 13 A. Not really. Because as I said before, 14 usually the patient they were scheduled to the 15 procedure and that patient already indicated that 16 they knew that they wanted. So they already made up 17 their mind. But despite that people still spend a 18 fair amount of time to discuss the risk. 19 MR. KULWICKI: Objection, move to 20 strike; nonresponsive. 21 BY MR. KULWICKI: 22 Q. Doctor, I'm asking a specific question 23 about a situation where you say usually patients 24 know. But let's say a situation where a patient 25 comes in and the information that they've gotten has 0093 1 given them a misguided notion about the benefits of 2 the procedure; in other words, they think it's much 3 more likely to be successful than it really is. And 4 let's say they come in and they think the risks are 5 a lot lower than what they really are and they also 6 don't appreciate that maybe they have other options 7 that might be safer courses or less risky courses 8 for them to take and they come in and they don't 9 have that information. Can we agree that it's not 10 the ideal circumstance to be giving that patient 11 information in a one-stop visit or a one-time visit 12 because they really don't have time to think about 13 the information that they're being provided about 14 the risks, benefits and alternatives? 15 MS. CARULAS: Objection. 16 A. This is a hypothetical, what you're 17 talking about, because we made an effort not to make 18 that happen. 19 BY MR. KULWICKI: 20 Q. Okay. But you would agree with that? 21 MS. CARULAS: Objection. 22 A. It's -- I would sort of generally -- 23 what you're saying is possible, but we really make 24 any effort to prevent that. 25 BY MR. KULWICKI: 0094 1 Q. And tell me about that. What -- prior 2 to a patient coming in for a one-stop visit, prior 3 to them coming in, what sort of information are they 4 given about the risks, benefits and alternatives 5 from The Cleveland Clinic? 6 A. We have -- 7 MS. CARULAS: Note an objection. 8 But go ahead. 9 A. We have seven or eight nurses that were 10 dedicated to the care of the patient. So we would 11 spend hours talking to them about this so they would 12 have very good -- beyond that they had already had 13 discussion with their local physician. Usually the 14 referral process for the most part come through a 15 caring in cardiology, whatever the patient needs. 16 So they already have discussion with the cardiology 17 there about alternative option. If the cardiology 18 sent it to us, they felt probably that they have 19 explored what is considered alternative option, 20 which beyond that still discuss with the patient. 21 BY MR. KULWICKI: 22 Q. Right. And in terms of what other 23 cardiologists knew, particularly cardiologists who 24 weren't performing this particular procedure, can 25 you agree that their knowledge base about the risks, 0095 1 benefits and alternatives, the success rate and the 2 complications, even how the procedure is being 3 performed, might not be as in depth as physicians at 4 The Cleveland Clinic who are actually doing the 5 procedure? 6 A. No. This is part of training cardiology 7 in general. This is people -- cardiology is 8 supposed to be aware of anything that has to do with 9 taking care of patient cardiac disorders so they are 10 aware of alternative treatment and the complication. 11 They are not a secret, you know, of The Cleveland 12 Clinic or any other center. This is something that 13 is, you know, well known and documented. 14 Q. So was it part of the policy and 15 practice at the clinic in 2006 to rely in part on 16 other physicians to give informed consent to your 17 patients prior to them coming for PVAI ablation? 18 MS. CARULAS: Objection. 19 A. I'm sorry? 20 BY MR. KULWICKI: 21 Q. Did you rely -- 22 A. We don't do informed consent over the 23 phone. We -- the patient discuss with the nurses 24 about information relative to procedure to the 25 alternative treatment, then this is rediscussed 0096 1 extensively with the patient at their -- in, you 2 know, person. 3 Q. The type of information that they get 4 over the phone, would that be something that would 5 be provided to the nurses by you or how would they 6 be trained to know what to tell patients who call in 7 about afib ablation back in 2006? 8 A. This is based on what we saw with -- you 9 know, this is one of the -- sort of the advantage of 10 having a database, you know, based on the result 11 that we had. So the complication would also base 12 on, you know, the complication that we had in our 13 center. So everybody should report their success, 14 their complication rate. That's very important. 15 And not everybody does, but, you know, that's 16 certainly one advantage of having a database. So 17 our information is fairly accurate because of that. 18 Q. And in terms of the information that 19 these nurses that would be manning the telephones 20 that they would disclose to patients, is that 21 something that you would have trained them on? 22 A. No. They -- actually all the nurses 23 were nurses that have extensive cardiovascular 24 training already for several years. And they 25 actually were responsible of updating the 0097 1 information in the database. So they are firsthand 2 knowledge of how the patients were doing, the 3 complication rate. So they would talk also by 4 personal experience. All of the composite data were 5 sort of put together by, you know, the statistician 6 fellow, but they actually were the one that first 7 knowledge of the information because they're the one 8 taking care of the patient. 9 Q. Right. Well, let me ask it this way, 10 Doctor, because -- 11 MR. KULWICKI: And I'm going to 12 object and move as nonresponsive. 13 BY MR. KULWICKI: 14 Q. What my question really was, was -- and 15 what I'm trying to figure out here is what kind of 16 information those nurses have. Do they have -- 17 first of all, question No. 1, are you involved in 18 training those nurses? 19 A. No. 20 Q. Second, would you be sitting there over 21 their shoulder witnessing what they're -- what kind 22 of conversations they're having with these patients 23 who call in to inquire about atrial fibrillation 24 ablation? 25 A. We didn't have to because the 0098 1 information -- 2 Q. Well, you answered my question. I'm 3 sorry, I'm just trying to get some information out 4 of you. 5 Okay. Question No. 3, were those 6 nurses supplied with any kind of script or 7 standardized data they would use to give information 8 to patients who call in, to your knowledge? 9 A. No, there is no script. 10 Q. And in terms of their training, you 11 know, you say experienced cardiovascular nurses. 12 The one that we've talked to is Stacy Poe, she 13 testified that she never, ever even saw an atrial 14 fibrillation ablation procedure performed. Would 15 that be the kind of person that you're talking about 16 that would be talking about how the procedure's 17 performed over the phone? 18 MS. CARULAS: Objection. 19 A. They don't -- no, the procedure detail 20 actually is discussed by the doctors. What they 21 talk about are -- information about outcomes and 22 risks, and they don't need to see a procedure to 23 have those information. 24 BY MR. KULWICKI: 25 Q. Mr. Sullivan was told over the phone 0099 1 that this was an in-and-out procedure and that all 2 he would need is a little Band-Aid after the 3 procedure. Do you think that that's an appropriate 4 thing for a nurse to tell a patient over the phone 5 to try get them to want to come and get this 6 procedure done? 7 MS. CARULAS: Objection. 8 A. The objective is not to get the patient 9 to come. This is a -- for most of the patients is 10 an outpatient procedure. 11 BY MR. KULWICKI: 12 Q. Right. But would you agree that saying 13 things like only need a little Band-Aid after the 14 procedure is kind of in the neighborhood of a 15 marketing ploy -- 16 A. No. 17 Q. -- as opposed to giving a patient a -- 18 (Simultaneous Discussion Interrupted 19 By Reporter.) 20 MS. CARULAS: I'm going to object as 21 to that was not Stacy Poe's testimony; that was the 22 patient's testimony. 23 But assuming the hypothetical, go 24 ahead. 25 A. Honestly, I mean -- so you have to 0100 1 verify that -- we certainly don't tell the nurses to 2 say that, but the truth of the matter is this is an 3 outpatient procedure where there is no incision, 4 there are only needles poking in the area. The 5 patient gets a bandage. That's all. 6 BY MR. KULWICKI: 7 Q. And, then, Doctor, in terms of 8 scheduling patients for procedures, was it the case 9 back in 2006 that a physician like yourself or 10 Dr. Burkhardt would schedule -- when they were doing 11 ablation procedures like this, PVAI ablation for 12 persistent afib, that they would only schedule two 13 such procedures per day? 14 A. No. 15 Q. How many would they schedule per day? 16 A. I scheduled three -- 17 Q. Three. 18 A. -- all the time. So it depends on the 19 level of comfort, the time, the scheduling time. I 20 usually do three. 21 Q. Right. And when one of these procedures 22 is canceled at the last minute, is that a problem in 23 terms of utilization of resources? 24 A. No. Because there is always a patient 25 in the hospital waiting for other things. So it is 0101 1 not a problem. 2 Q. Certainly if one of these procedures -- 3 I know they're expensive procedures to perform. If 4 one is canceled, the clinic would lose out on that 5 money, right? 6 MS. CARULAS: Objection. 7 A. That certainly is not a priority, no. 8 The clinic never forces anybody to fill the spot 9 or -- you know, this is something that if we can -- 10 if we have somebody else waiting in the hospital for 11 a procedure, if there is an opening, then that 12 patient is put on the schedule. Otherwise, you 13 know, the case is canceled and that's the way it is 14 for that day. 15 BY MR. KULWICKI: 16 Q. Right. And in terms of physician 17 compensation at the clinic back in 2006, was 18 there -- were there incentives -- in other words, if 19 a particular surgeon did a lot of ablations and one 20 did half as many, would their compensation be 21 different? 22 MS. CARULAS: Objection. 23 A. No, not really. 24 MS. CARULAS: It's 10:01, just so 25 you know. 0102 1 A. Honestly I don't know because no -- even 2 as a surgeon I had no idea what everybody else was 3 making, but, you know, everybody never shared their 4 salary and it's not based on -- it is based on many 5 factors, including teaching, publication, you know, 6 not -- certainly not necessarily on the number of 7 procedures that people do. 8 BY MR. KULWICKI: 9 Q. Would the procedures -- the number of 10 procedures be a factor? 11 MS. CARULAS: Objection. 12 A. I don't think so. 13 BY MR. KULWICKI: 14 Q. Doctor -- 15 MS. CARULAS: What are you doing? 16 Have you -- 17 MR. KULWICKI: I'm almost done. I'm 18 almost done. 19 BY MR. KULWICKI: 20 Q. Doctor, what was the reason why your 21 contract at the clinic was not renewed; do you know? 22 MS. CARULAS: Objection. 23 A. It is on the Internet. It has nothing 24 to do with this case. All the information regarding 25 that is on the Internet. 0103 1 BY MR. KULWICKI: 2 Q. Well, can you tell me? 3 MS. CARULAS: Objection. 4 A. I don't think it's relevant to this 5 case. It has nothing to do with this, so I don't 6 see why you should care. 7 BY MR. KULWICKI: 8 Q. Well -- 9 MS. CARULAS: We're not going to go 10 any further, David. I mean, it's -- it is totally, 11 completely irrelevant to this case. Okay? 12 MR. KULWICKI: I don't know what the 13 reason is, so how do I know it's relevant or not? I 14 mean, I -- 15 A. I can tell you it's not relevant, so it 16 is none of your business. 17 BY MR. KULWICKI: 18 Q. Well, you've told me a lot of things 19 today that we may disagree about. 20 A. Well, that's -- yeah. 21 Q. Was Dr. Burkhardt's departure from the 22 clinic related to your departure? In other words, 23 did -- was the contract -- was his contract not 24 going to be renewed -- 25 A. No. 0104 1 Q. -- and so he took off? 2 A. He decided to come and join me as other 3 physicians and nurses. 4 Q. Did he come directly here from 5 Cleveland? 6 A. No, he actually went to Las Vegas first. 7 MR. KULWICKI: I think I'm done. 8 MS. CARULAS: Okay. You have the 9 right -- 10 MR. KULWICKI: Wait. Just let me -- 11 give me a second. 12 Appreciate your time, Doctor. Let 13 me just look at this real quick and make sure I'm 14 not missing anything. 15 MS. CARULAS: While we do it, you 16 have the right to read over the transcript and make 17 sure it's been taken down accurately, so I recommend 18 that. We won't waive signature. 19 THE WITNESS: Especially with the 20 accent, right? 21 MS. CARULAS: If he orders a -- he 22 ordered a copy, I'll order it, I will take a copy. 23 And then if you fellows will send me the video and 24 the transcript, you don't need to send it to him. 25 In other words, I'll send it to him. Okay? 0105 1 MR. KULWICKI: That's all I have. 2 Thanks, Doctor. Appreciate your time. 3 THE VIDEOGRAPHER: Off the record at 4 10:03. 5 (Deposition concluded at 10:03 a.m.) 6 ù ù ù 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 0106 1 CORRECTIONS AND SIGNATURE 2 PAGE/LINE CORRECTION REASON FOR CHANGE 3 ____________________________________________________ 4 ____________________________________________________ 5 ____________________________________________________ 6 ____________________________________________________ 7 ____________________________________________________ 8 ____________________________________________________ 9 ____________________________________________________ 10 ____________________________________________________ 11 ____________________________________________________ 12 ____________________________________________________ 13 I, ANDREA NATALE, M.D., have read the 14 foregoing deposition and hereby affix my signature that same is true and correct except as noted 15 herein. 16 ____________________________ ANDREA NATALE, M.D. 17 18 STATE OF _____________ ) 19 COUNTY OF ____________ ) 20 Subscribed and sworn to before me by the said witness, ANDREA NATALE, M.D., on this the 21 _________ day of ________________, 2010. 22 ____________________________ 23 NOTARY PUBLIC IN AND FOR THE STATE OF________________ 24 25 My Commission Expires: _______________ 0107 1 C E R T I F I C A T E 2 3 I, Micheal A. Johnson, Registered 4 Professional Reporter and Notary Public in and for 5 the State of Texas, certify that on the 7th day of 6 September, 2010, I reported the Videotaped Oral 7 Deposition of ANDREA NATALE, M.D., after the witness 8 had first been duly cautioned and sworn to testify 9 under oath; said deposition was subsequently 10 transcribed by me and under my supervision and 11 contains a full, true and complete transcription of 12 the proceedings had at said time and place. 13 I further certify that I am neither 14 counsel for nor related to any party in this cause 15 and am not financially interested in its outcome. 16 GIVEN UNDER MY HAND AND SEAL of 17 office on this 20th day of September, 2010. 18 19 20 ________________________________________ MICHEAL A. JOHNSON, RPR, CRR, CLR 21 NCRA Registered Professional Reporter NCRA Certified Realtime Reporter 22 Certified LiveNoteÖ Reporter 23 Notary Public in and for the State of Texas 24 My Commission Expires: 8/8/2012 25