0001 1 IN THE COURT OF COMMON PLEAS CUYAHOGA COUNTY, OHIO 2 - - - - - 3 4 Shannon Sullivan, et al., ) Judge Brendan J. ) Sheehan 5 Plaintiffs, ) ) 6 vs. ) ) Case No. 7 The Cleveland Clinic ) CV-09-697617 Foundation, ) 8 ) Defendant. ) 9 10 - - - - - 11 12 Deposition of: JENNIFER E. CUMMINGS, M.D. 13 14 15 April 8, 2010 5:11 p.m. 16 17 18 Location: Roetzel & Andress, LPA 222 South Main Street 19 Akron, Ohio 20 21 Reporter: Christine Leisure, Notary Public 22 23 24 25 0002 1 APPEARANCES: 2 3 On behalf of the Plaintiffs: DAVID A. KULWICKI, ESQ. 4 Becker & Mishkind Co., LPA 1660 West Second Street 5 Skylight Office Tower, Suite 660 Cleveland, OH 44113 6 866.477.4097 dkulwicki@beckermishkind.com 7 8 On behalf of the Defendant: 9 ANNA MOORE CARULAS, ESQ. Roetzel & Andress, LPA 10 1375 East Ninth Street One Cleveland Center, Ninth Floor 11 Cleveland, OH 44114 216.623.0150 12 acarulas@ralaw.com 13 14 - - - - - 15 16 ALSO PRESENT: Michelle Mahon 17 18 - - - - - 19 20 21 22 23 24 25 0003 1 I N D E X 2 EXAMINATION OF JENNIFER E. CUMMINGS, M.D. 3 Page Line 4 BY MR. KULWICKI...................4 6 5 6 7 EXHIBITS MARKED 8 Deposition Exhibit 1 .............4 23 Deposition Exhibit 2 .............15 4 9 Deposition Exhibit 3 .............16 6 Deposition Exhibit 4 .............25 8 10 Deposition Exhibit 5 .............34 14 Deposition Exhibit 6 .............35 17 11 Deposition Exhibit 7 .............37 8 Deposition Exhibit 8 .............53 22 12 13 14 - - - - - 15 16 17 18 19 20 21 22 23 24 25 0004 1 JENNIFER E. CUMMINGS, M.D., of lawful 2 age, called for examination, being by me first 3 duly sworn, as hereinafter certified, deposed and 4 said as follows: 5 EXAMINATION OF JENNIFER E. CUMMINGS, M.D. 6 BY MR. KULWICKI: 7 Q. Doctor, if you would kindly state your 8 full name and spell your last name for us. 9 A. Jennifer Eiko Cummings, C-u-m-m-i-n-g-s. 10 Q. And, Doctor, where are you currently 11 employed at? 12 A. Akron General Medical Center. 13 Q. And what is your current business 14 address? 15 A. 224 West Exchange, Suite 225, Akron, 16 Ohio. 17 Q. Thank you. 18 Back in August of 2006, were you 19 employed by The Cleveland Clinic? 20 A. Yes. 21 Q. I'm going to mark as Exhibit 1 a copy of 22 your Curriculum Vitae. It is 20 pages long. 23 (Deposition Exhibit 1 was marked for 24 purposes of identification.) 25 Q. Is this current, accurate and complete? 0005 1 A. As last updated July 2009. 2 Q. Okay. And since July 2009, have you 3 added anything of significance to your CV that 4 you can think of? 5 A. No. 6 Q. What was your position or title at 7 The Cleveland Clinic back in August of 2006? 8 A. Staff cardiologist. 9 Q. And in terms of the type of activities 10 that you were engaged in, were you engaged in 11 clinical as well as research activities? 12 A. Yes. 13 Q. In terms of your clinical activities, 14 can you describe what sort of procedures and 15 medical care you provided back then? 16 A. I was an electrophysiologist, so I would 17 do electrophysiology procedures and I rounded on 18 electrophysiology patients. 19 Q. And what percentage of your time was 20 spent in clinical activities, doing procedures 21 and rounding on patients, as opposed to 22 administrative or research types of activities? 23 A. I'm trying to remember back to 2006. 24 At that time I believe the majority of my 25 responsibilities were clinical, so probably about 0006 1 80 percent clinical, 20 percent research. 2 Q. All right. I read somewhere where you 3 described yourself as being an avid researcher. 4 Is that accurate? 5 A. I enjoy research. 6 Q. Okay. In terms of your activities at 7 The Cleveland Clinic, back in August of 2006 were 8 you involved in a number of research projects? 9 A. I was involved in some research 10 projects, I believe. 11 Q. Was all of your research in 2006 12 oriented towards electrophysiology procedures? 13 A. I would have to look back at my CV at 14 that time period, but they were not centered on 15 procedures. It encompassed all of 16 electrophysiology, ranging from microbiology to 17 procedures, I suppose. 18 Q. In terms of your clinical activities 19 back in August of 2006, were you performing 20 catheter ablations for patients with A-fib? 21 A. Yes. 22 Q. In terms of your research activities, 23 were you involved in investigating ablation 24 catheters back in August of '06? 25 A. I will have to refer to what protocols 0007 1 were going on at that time. I can't recall. 2 Q. And what would you look at to determine 3 what protocols were going on at that time? 4 A. The IRB would have a list of all active 5 protocols during that time. 6 Q. Can you better identify what that list 7 would be? Is there one specific to EP 8 procedures? 9 A. I don't understand the question. 10 Q. You mentioned a list of -- I think you 11 said protocols, research protocols that the IRB 12 would have, and I was asking if they would be 13 sort of narrowed down to EP procedures. 14 A. I was never on the IRB, so I don't know 15 how they file them. 16 Q. Okay. How do you know that they 17 maintain a list of protocols? 18 A. They're required to approve all 19 protocols that happen. 20 Q. Do you know if at the time you were 21 involved in any investigation for navigational 22 equipment or mapping equipment or would your 23 answer be the same? 24 A. My answer would be the same. 25 Q. How about with respect to submissions to 0008 1 the innovation committee at Cleveland Clinic, 2 would you have in this timeframe been performing 3 procedures that were the subject of any protocol 4 before the innovation committee at The Cleveland 5 Clinic? 6 A. I don't know of an innovation committee. 7 I don't believe there is one. 8 Q. The Innovation Practice Committee, you 9 weren't familiar with that? 10 A. No, sir. 11 Q. Back in August of 2006, did you have any 12 consulting or research agreements personally with 13 Stereotaxis or Biosense Webster? 14 A. No. 15 Q. Did The Cleveland Clinic to your 16 knowledge back in August of '06? 17 A. I don't have any knowledge of that. 18 Q. Have you ever acted as an expert in a 19 medical-legal matter? 20 A. No. 21 Q. Have you given a deposition prior to 22 this one? 23 A. No. 24 Q. Are you aware of any other lawsuits 25 pending against The Cleveland Clinic that arise 0009 1 out of complications from an ablation procedure? 2 MS. CARULAS: Objection. 3 A. No. 4 Q. And I apologize for asking, Doctor: 5 Have any of your privileges at any hospital been 6 suspended, revoked or called into question in any 7 manner? 8 MS. CARULAS: Objection. 9 A. No. 10 Q. Has your license to practice medicine 11 been suspended, revoked or called into question 12 in any manner? 13 A. No. 14 Q. And have you ever been the subject of 15 any disciplinary proceedings? 16 A. No. 17 Q. Why did you -- when did you leave 18 The Cleveland Clinic? 19 A. My last day was September 30th, 2008. 20 Q. And what was your reason for leaving? 21 A. I had accepted a huge opportunity at 22 Akron General for a big promotion. 23 Q. When you came to Akron General, did you 24 come with Dr. Kanj and Dr. Burkhardt or did they 25 come separately, at different times? 0010 1 A. I came on my own. 2 Q. Did they come at the same time? 3 A. No. 4 Q. What was the reason for Dr. Burkhardt 5 leaving the Clinic? 6 MS. CARULAS: Objection. Go ahead. 7 A. You would have to ask Dr. Burkhardt. 8 Q. What did he tell you? 9 MS. CARULAS: Objection. Go ahead. 10 A. From my understanding, his wife had 11 accepted a position at Las Vegas and it was very 12 difficult with two children to live far apart 13 from each other. 14 Q. But I thought he went from the Clinic to 15 Akron General. 16 A. No. 17 Q. Dr. Burkhardt? 18 A. There are several individuals who had 19 temporary privileges at Akron General, but he did 20 not accept a permanent position at Akron General. 21 Q. Was Dr. Kanj ever at Akron General? 22 A. From my understanding, he was there 23 prior to my arrival. 24 Q. Okay. And how about Dr. Schweikert? 25 A. He's currently there. 0011 1 Q. Was he there before you came to Akron 2 General? 3 A. Yes. 4 Q. How many other Cleveland Clinic, former 5 Cleveland Clinic employees or residents are at 6 Akron General currently? 7 A. In Akron General Hospital? 8 Q. In the EP Department, sorry. 9 A. There are currently two 10 electrophysiologists, myself and Dr. Schweikert. 11 Q. Okay. Doctor, in preparation for 12 today's deposition, what materials did you 13 review? 14 A. I reviewed my note and some of the notes 15 prior to my note. 16 Q. And by your note, are you talking about 17 your staff note post stroke? 18 A. Is that the one from August like 19th or 19 something? Yes. 20 Q. 18th, okay. 21 Do you remember this patient? 22 A. Yes. 23 Q. What do you remember -- well, let me ask 24 it a different way. 25 Do you have a recollection of the 0012 1 patient such that you can describe what he looked 2 like? 3 A. No. 4 Q. Is your recollection of the patient 5 limited to what you recorded in your note? 6 A. Yes. 7 Q. And aside from your note, do you have a 8 recollection of any discussions with the patient? 9 A. The patient? 10 Q. Yes. 11 A. No. 12 Q. Or his wife. 13 A. I don't recall specifically. 14 Q. Okay. Besides the medical record, have 15 you looked at anything else regarding this 16 patient? 17 A. No. 18 Q. And based on your review of whatever 19 materials you reviewed, is it your belief sitting 20 here today that your first involvement with this 21 patient was on August 18 when you saw him on 22 rounds after he had suffered a stroke? 23 A. When I saw the patient? 24 Q. Your first involvement with the patient. 25 A. Define "involvement." 0013 1 Q. Okay. Talk to, touch, saw, gave advice 2 with respect to, provided care, treatment, had 3 any engagement, you know, the common use of the 4 term "involved." 5 A. I first saw the patient that morning, 6 correct. 7 Q. Okay. So I take it you were not 8 involved in obtaining informed consent from the 9 patient prior to his ablation procedure, true? 10 A. True. 11 Q. And you did not observe any other 12 physician or other employee of The Cleveland 13 Clinic obtaining informed consent from this 14 patient prior to the ablation procedure, true? 15 A. Correct. 16 Q. Do you have any notes, have you prepared 17 any notes other than notes that are contained 18 within The Cleveland Clinic chart with respect to 19 this patient? 20 A. No. 21 Q. Let me ask you about the EP Department 22 at the Clinic back in August of '06. 23 Was the atrial fibrillation center or 24 whatever you call it, was that a subdepartment or 25 a separate unit of the EP Department back in 0014 1 August of '06? 2 A. I don't know how the political structure 3 or the financial structure of the Clinic was 4 created. 5 Q. Okay. Was there a department that had a 6 name like the Center for Atrial Fibrillation or 7 something like that back in August of '06 at the 8 Clinic? 9 A. There was a Center for Atrial 10 Fibrillation. The infrastructure, I don't know. 11 Q. Was there anyone who was designated as, 12 say, the chairman of that section back in August 13 of '06? 14 A. I'm trying to remember. I believe at 15 the time the Center for Atrial Fibrillation was 16 part of the electrophysiology section, but I 17 don't know if there were separate titles or how 18 the infrastructure worked. 19 Q. Do you know if there was a chairman of 20 the Department of Electrophysiology or the 21 electrophysiology unit back in 2006? 22 A. I don't know if the official title is 23 chairman or director, but there was a chairman of 24 electrophysiology. 25 Q. And who was that? 0015 1 A. Andrea Natale. 2 Q. I'm going to hand you what I'll mark as 3 Exhibit 2. 4 (Deposition Exhibit 2 was marked for 5 purposes of identification.) 6 Q. Doctor, I'm going to hand you a two-page 7 note dated August 18 at 7:30 a.m. It was 8 previously marked at Dr. Bermel's deposition as 9 Bermel Exhibit 3. 10 Is that the note that you referenced 11 earlier as what you read in preparation for 12 today's deposition? 13 A. Yes. 14 Q. And based on your review of the chart, 15 is that the only thing that you authored in this 16 patient's chart? 17 A. I believe there may be some follow-up 18 notes, but I don't recall specifically. 19 Q. Would your involvement with this patient 20 based on your review of the record be limited to 21 rounding on him as one of the attendings on the 22 EP staff? 23 A. He was admitted to me that night, so the 24 phone calls in the evening as well as rounding on 25 him as part of EP staff were my responsibility. 0016 1 Q. This note at 7:30 a.m. in Exhibit 2, 2 would that have been the first time that you saw 3 this patient? 4 A. The first time I saw that patient would 5 be in the morning, correct. 6 (Deposition Exhibit 3 was marked for 7 purposes of identification.) 8 Q. Okay. I'm going to hand you what we've 9 marked as Exhibit 3, which is a two-page document 10 previously marked as Bermel Exhibit 1, and I 11 believe it's from the electronic orders. 12 Does this look familiar to you in any 13 respect? 14 A. I have not seen it before. 15 Q. It has a number of orders on it, 16 including on the second page orders that have 17 your name relative to a CT scan that was 18 performed the day before your progress note. 19 Can you tell me how it would come to be 20 that your name would appear on an order before 21 you actually saw the patient? 22 A. Protocol is that one physician is 23 assigned to receive admissions during a two-week 24 process. I was the physician on service. So 25 when patients are admitted, they're admitted to 0017 1 me. 2 Q. Did you make these orders for the CT 3 scan? 4 A. Pre-op orders are ordered by the 5 admitting physician as part of standard orders. 6 They're registered under me. 7 Q. Well, but this isn't a pre-op order. 8 This is post-op. His operation was on the 9 morning of the 17th. This is about 10:00 at 10 night on the 17th, they had a CT ordered for 11 evaluation of his stroke. 12 A. Oh, second page. Sorry. 13 Q. Yes. 14 MS. CARULAS: So you're talking about 15 this one right here? You're asking her why this 16 CT scan -- 17 A. Is under my name, is that the question? 18 Q. Correct, yes. 19 A. Because I'm the physician of record. 20 Q. Okay. And I'm just trying to clarify 21 why it would be. You didn't actually order the 22 CT scan, correct? 23 A. CT scan, every order that's placed on 24 that patient after admission is registered under 25 me because the patient -- I'm the attending of 0018 1 record. 2 Q. Would you have been the attending of 3 record when the procedure was performed? 4 A. No. I become the attending of record 5 upon arrival to the floor. They're admitted to 6 me. I'm the service attending. I don't do 7 procedures during that time. 8 Q. So even though the stroke service was 9 called relative to this patient, the patient 10 wasn't transferred to their service; is that 11 true? 12 A. He was eventually transferred to their 13 service. 14 Q. Can you tell me when he would have been 15 transferred to the stroke service? 16 A. When he moved to the Neuro Intensive 17 Care Unit. 18 Q. Do you think you were consulted relative 19 to this patient before your note set forth in 20 Exhibit 2? 21 A. Yes. 22 Q. And what makes you think that? 23 A. As I document in my note from 7:30 that 24 morning. 25 Q. And tell me when you believe you were 0019 1 first notified. 2 A. I received a call from the cardiology 3 fellow - I remember that - letting me know that 4 there was suspicion of a stroke and the patient 5 was going to a CT scanner. 6 Q. And do you think you were contacted 7 after that? 8 A. Yes. 9 Q. At what time? 10 A. I don't recall. 11 Q. I don't see in this note where it says 12 that you were contacted by the cardiology fellow. 13 Does it? 14 A. The note does not contain that. 15 Q. Okay. But you have an independent 16 recollection of that? 17 A. Yes. 18 Q. What was his name? 19 A. By reviewing the records, I see his name 20 was Dr. Meadows, but I didn't recall that on my 21 own. 22 Q. And what do you recall Dr. Meadows 23 telling you? 24 A. What I had said earlier, that one of the 25 patients from the procedure earlier had 0020 1 suspicious signs for a stroke and he was on his 2 way to the CT scanner. 3 Q. Okay. And did you have any other 4 conversations with Dr. Meadows? 5 A. I believe I spoke with him later. I 6 asked him to give me updates along the way. 7 Q. And what did he tell you? What other 8 conversations do you recall having with 9 Dr. Meadows? 10 A. I remember being updated. I don't 11 recall if it was Dr. Meadows or another resident. 12 I remember being updated that he was at the CT 13 scanner and it was a large infarct. And then 14 later in the team I was notified that they had 15 decided not to intervene as documented in the 16 record. 17 Q. And you remember this going back four 18 years ago? 19 A. I remember some of the details, as I 20 said. Some of the details I don't remember. 21 Q. Well, you told me earlier that your 22 recollection of events was limited to your note, 23 but now you're telling me you remember from your 24 note, but also you remember in your mind's eye a 25 conversation that you had four years ago. 0021 1 Is that what you're telling us here? 2 A. As I stated previously, I remember 3 pieces parts, but the majority of the 4 recollection is what is documented in my notes. 5 Q. And you didn't document these 6 conversations with Dr. Meadows or some other 7 unidentified stroke resident, right? 8 A. It documents the most important 9 conversation, which was at 12:55, I suppose. But 10 everything that is important for the patient care 11 is documented. 12 Q. So the most important documentation is 13 what happened before he had a CT scan in your 14 opinion? 15 A. Excuse me? 16 Q. Are you saying -- you said that the most 17 important documentation is a conversation at 18 12:55 a.m. Is that what your testimony is? 19 A. That is not before the CT scan, sir. 20 Q. Okay. I see that now. 21 You note at the bottom of the page from 22 the EP standpoint, patient with no cardiac 23 diagnosis, what does that mean, Doctor? 24 A. No cardiac disease, sir, d-x, disease. 25 Q. And then tell me what else you wrote 0022 1 there. 2 A. It states there is no contraindication 3 to any aggressive neuro treatments deemed 4 necessary at this time, including 5 anticoagulation, thrombolysis, from an EP 6 standpoint. 7 Q. And let me guess, you disagree with that 8 today? You have a different take on that? Let 9 me guess. Is that right? 10 MS. CARULAS: Objection. What is this 11 about, Dave? This sarcasm -- 12 MR. KULWICKI: Oh, Anna, sarcasm and 13 you're complaining about it, Ms. Sarcastic? I'm 14 asking questions, okay. I'm going to take this 15 deposition. 16 MS. CARULAS: Well, you can take the 17 deposition but -- I mean, come on, be respectful 18 of the witness. 19 Q. Okay. Doctor, do you agree with what 20 you wrote there today? 21 A. I believe that, yes. 22 Q. Okay. The next page you say, We would 23 typically have started anticoagulation last night 24 post PVI. 25 Do you know why that wasn't done, why 0023 1 Lovenox was not started post PVI? 2 A. It was ordered and typically twice a day 3 medications would have been administered at 10:00 4 and 10:00. He had a stroke prior to that. I 5 would presume that it was the stroke that stopped 6 the order. 7 Q. He was not anticoagulated from the time 8 this procedure ended to the time of his stroke, 9 true? 10 A. You would have to review the medical 11 records. 12 Q. Well, is that the way it's supposed to 13 be done? 14 A. The Lovenox would be given later that 15 evening after the end of the procedure, correct. 16 Q. So immediately after procedure where 17 instrumentation is put inside the heart, heating 18 elements within the heart, and you stop 19 anticoagulation on the patient for approximately 20 three hours from the time the procedure is over 21 to the time of the stroke. 22 What would be the clinical reason for 23 stopping anticoagulation during that time? 24 A. To prevent bleeding complications from 25 the multiple areas of access. 0024 1 Q. Would you agree that the patient is at 2 an increased risk of stroke during that 3 three-hour period following that procedure when 4 he's not anticoagulated? 5 A. I don't believe there's any data to 6 support that statement. 7 Q. Well, how about the studies that show 8 that the patients who have strokes after ablation 9 procedures have it when they have a 10 nontherapeutic INR? 11 A. You would have to show me the 12 literature. 13 Q. Do you disagree with that literature? 14 Do you disagree with what I just said? 15 A. You would have to show me the 16 literature. 17 Q. Well, you're the expert. 18 Do you agree that patients that have a 19 subtherapeutic INR are at increased risk of 20 stroke after these procedures? 21 A. You would have to show me the literature 22 you're quoting, sir. 23 Q. Do you disagree with that? 24 A. There are a lot of medical situations 25 that outline risk and benefit in that situation, 0025 1 so that's not really a fair question to ask. 2 There's risk and benefit with 3 anticoagulation and there's risk and benefit with 4 the ablation, so you would have to look at the 5 risk and benefit. 6 Q. Doctor, I'm going to hand you what I'll 7 mark as Exhibit 4. 8 (Deposition Exhibit 4 was marked for 9 purposes of identification.) 10 Q. It's an article by Dr. Patel, Long-Term 11 Functional and Neurocognitive Recovery in 12 Patients Who Had an Acute Cerebrovascular Event 13 Secondary to Catheter Ablation for Atrial 14 Fibrillation. 15 And I will point to you the paragraph 16 that says, From January 2000 to June 2007, 3,060 17 atrial fib patients had undergone pulmonary vein 18 antrum isolation at The Cleveland Clinic. All 19 patients that had a cerebral thromboembolic event 20 during or within 48 hours of radiofrequency 21 ablation were selected from a prospectively 22 collected database. 23 Are you familiar with this study? 24 A. Yes. 25 Q. And doesn't this study conclude that in 0026 1 all of the patients who have a stroke post PVAI 2 ablation from this study, all of them had 3 subtherapeutic INRs? 4 A. You would have to show me the study. 5 I don't remember it specifically. 6 MS. CARULAS: Take your time. 7 (Discussion had off record.) 8 A. I would have to review all of this to 9 say all the patients. The paper states that. 10 Q. Okay. Can we agree that having a 11 subtherapeutic INR is a risk factor for stroke 12 post PVAI ablation? 13 A. Yes. 14 Q. Doctor, do you have an opinion as to 15 what was the cause of Mr. Sullivan's stroke? 16 A. Stroke is a risk of this procedure. 17 Q. Okay. But what physiologically more 18 likely than not was the cause of his stroke? 19 A. It's a risk of this procedure. I don't 20 know why specifically he had a stroke. 21 Q. Well, did you go back and look at his 22 procedure to see what was -- how the procedure 23 was performed or talk with Dr. Kanj or talk with 24 Dr. Burkhardt to discuss how the procedure was 25 performed? 0027 1 A. No. 2 Q. You had no intellectual curiosity in 3 determining why this guy who sustained a massive 4 stroke, why this likely happened? 5 A. No. It's a risk of the procedure. 6 Q. Would you agree that it's a material 7 risk of the procedure? 8 A. Define "material." 9 Q. Well, that it is a risk that you would 10 tell patients about when they're considering 11 whether to undergo the procedure. 12 A. Yes. 13 Q. Okay. If patients call in to the Clinic 14 based on their website, the A-fib website or the 15 website that talked about A-fib back in August of 16 '06, who would they talk to? 17 A. I don't know. 18 Q. Did you have any role in preparing that 19 website? 20 A. I don't know. I don't think so. I 21 don't recall. I have never been to the website. 22 Q. Why is stroke a risk of the procedure? 23 A. Atrial fibrillation in itself is a risk 24 of stroke and then the procedure carries with it 25 a risk of stroke. 0028 1 Q. And why? I mean you keep saying it's a 2 risk of stroke, but why is what I want to know. 3 A. It has been shown in studies that stroke 4 is a risk of this procedure. I don't think 5 there's any specific literature that elucidate 6 the exact mechanism by which thrombus is created. 7 Q. Do you know how his procedure was 8 performed? 9 A. Yes. 10 Q. How was it performed? 11 A. In general? 12 Q. Yes. 13 A. Through catheters placed in the groin 14 and neck. 15 Q. What kind of catheter was used to 16 perform his procedure? 17 A. I don't know. I did not look. 18 Q. At the time that you provided care to 19 him, would you have gone back and looked at the 20 operative note at all? 21 A. No. 22 Q. And you didn't have any discussions with 23 Dr. Burkhardt or Dr. Kanj about this patient? 24 A. About the equipment used, no. 25 Q. How about discussions about the stroke? 0029 1 A. At the time of the stroke? 2 Q. Yes. 3 A. That evening I contacted Dr. Burkhardt 4 to inform him of the complication. 5 Q. And tell me what discussion took place. 6 A. I informed him that his patient appeared 7 to have suffered a stroke and I would keep him 8 updated as to what happened. 9 Q. And what did he tell you? 10 A. Keep me updated. 11 Q. Did he come in to see the patient? 12 A. You'll have to ask Dr. Burkhardt that. 13 Q. Well, did you see him? 14 A. I did not see him. 15 Q. Did he tell you he was coming in to see 16 the patient? 17 A. I don't recall. 18 Q. Are there any notes that reflected that 19 he came in and saw the patient? 20 A. Not in the notes I reviewed, but I only 21 reviewed my notes and notes prior. He does have 22 a note following mine. 23 Q. A what? I'm sorry. 24 A. There is a note following mine, I 25 believe. 0030 1 Q. With respect to obtaining informed 2 consent for patients undergoing A-fib ablation 3 back in August of 2006, was there any written 4 protocol for EPs at The Cleveland Clinic to 5 follow in terms of what risks to disclose and 6 what benefits to discuss with the patient? 7 I'm talking about a written protocol. 8 A. Not to my knowledge. 9 Q. So with every patient you would sit down 10 and try to recall the list of risks and the list 11 of benefits or the success rates for a particular 12 procedure; is that how it would go, as opposed to 13 having what I would call like a cheat sheet that 14 you could look at and say I want to make these 15 disclosures to you? 16 A. There's no cheat sheet. 17 Q. Okay. So you had to go from 18 recollection with each patient, correct? 19 A. Correct. 20 Q. Can we agree that in August of 2006 the 21 success rate for PVAI ablation for patients with 22 persistent A-fib was lower than what it was for 23 patients with peroxisomal A-fib? 24 A. Yes. 25 Q. And can you quote what the Clinic was 0031 1 quoting back in -- well, what you were quoting to 2 your patients back in August of '06 in terms of 3 the success rate for those two procedures? 4 A. I really don't -- 5 MS. CARULAS: I'm going to have a 6 continuing line of objection to all these 7 questions because obviously she's a fact witness 8 here to talk about her involvement. 9 But go ahead. I mean it's irrelevant, 10 but go ahead. 11 A. Could you repeat the question again? 12 Q. Sure. What you were quoting as the 13 success rate for persistent versus peroxisomal 14 A-fib treated by PVAI ablation. 15 A. I don't remember what our success rate 16 was five years ago. 17 Q. What risks of the procedure would you 18 discuss with your patients undergoing PVAI 19 ablation with persistent A-fib? 20 A. The risk of stroke, death, heart attack, 21 perforation, hemorrhage, open-heart surgery, 22 shock, respiratory failure. We would talk about 23 the risk of esophageal complications as well as 24 the risk of pulmonary vein stenosis. 25 Q. Anything else? 0032 1 A. That encompasses the major risks. 2 Then we would go through the entire 3 procedure from beginning to end and I would draw 4 on a diagram the picture, exactly where the 5 catheters would go, how the procedure would ensue 6 and what their risks were. 7 Q. Prior to the procedure, would patients 8 have a TEE performed to look for thrombus in the 9 left heart? 10 A. Either a CT scan or a TEE was done. 11 Q. Difference in efficacy between the CT 12 and the TEE for finding left heart thrombus? 13 A. I don't think there's any paper to 14 discuss it now at this time, but it was 15 considered the same efficacious. There was some 16 literature at the time. 17 Q. In what cases would you do a TEE as 18 opposed to a CT to evaluate for left heart 19 thrombus? 20 A. Whichever was available, whichever we 21 could do, whichever we needed. 22 Q. With respect to the practice back in 23 August of '06 in terms of obtaining informed 24 consent from patients, did the nurse practitioner 25 have any involvement with that process or was 0033 1 that something that the physician alone would go 2 through with the patient? 3 MS. CARULAS: You're talking about what 4 she, Dr. Cummings did, or her knowledge of what 5 Dr. Burkhardt's practice was? 6 MR. KULWICKI: I said what was the 7 practice at The Cleveland Clinic in '06. That's 8 what I asked. 9 A. I can only tell you what I practiced. 10 Q. Fine. Go ahead. 11 A. My practice was I had a nurse, not a 12 nurse practitioner, and they would go through the 13 procedure and then I would go in and I would 14 re-discuss the procedure. 15 Q. Would the nurse -- by the way you 16 practiced, would the nurse obtain informed 17 consent separate and apart from you? 18 A. They would educate the patient. 19 Q. In terms of documenting informed consent 20 back in 2006, how did you do that? 21 MS. CARULAS: Same objection. Go ahead. 22 A. We would document in the notes risks, 23 benefits and alternatives discussed with the 24 patient. 25 Q. Did you do that by checking a box on an 0034 1 electronic medical record or did you hand write 2 that in? 3 A. I hand typed it in. 4 Q. And would you type that into the EPIC 5 system or some other way? 6 A. EPIC in the outpatient arena. 7 Q. And by "outpatient arena," what are you 8 referring to? 9 A. When I saw the patient as an outpatient 10 prior to their procedure. 11 Q. Were these procedures you always 12 scheduled as outpatient procedures? 13 A. Yes, as far as I know, for my practice. 14 (Deposition Exhibit 5 was marked for 15 purposes of identification.) 16 Q. I'm going to mark as Exhibit 5 another 17 portion of Mr. Sullivan's medical record. This 18 is five pages, Doctor, that includes a pre-op EKG 19 and a pre-op echo. They appear to have both been 20 -- well, strike that. 21 MS. CARULAS: Dave, why are you asking 22 her about this if she wasn't involved in any of 23 this? 24 MR. KULWICKI: Her name is on this 25 record. 0035 1 MS. CARULAS: She's explained the 2 electronic medical record -- 3 MR. KULWICKI: This is different. 4 MS. CARULAS: All right. I apologize. 5 I thought you said pre-op so I thought we were 6 going into all the pre-op. 7 MR. KULWICKI: You know what, you're 8 right, Anna, and I'm going to set that aside. 9 Q. Set that aside, Doctor. I apologize. 10 I misread this. 11 A. Would you still like it labeled as an 12 exhibit? 13 Q. Yes, we'll keep it as 5 since I called 14 it that. We label our mistakes too. 15 I'm going to hand you what I'll mark as 16 Exhibit 6. 17 (Deposition Exhibit 6 was marked for 18 purposes of identification.) 19 Q. And this is a three-page document that 20 purports, Doctor, to be I believe the operative 21 report from Dr. Burkhardt's ablation procedure, 22 correct? 23 A. That's what it appears to be. 24 Q. Now, on page 2, about midway down, it 25 says "Reviewed by list" and it has you listed as 0036 1 having reviewed this on Tuesday, August 22, at 2 4:30 p.m. 3 Can you tell me why you would have been 4 reviewing Dr. Burkhardt's op note a couple of 5 days after the patient's surgery and a couple of 6 days after the patient had that complication? 7 A. I don't remember. I don't remember. 8 Q. Would there be any clinical reason based 9 on your review of your involvement in this 10 patient's post complication care why you would be 11 going back to look at the op note a couple of 12 days after the procedure? 13 A. I continued to round on the patient for 14 several days, so I was still taking care of him 15 clinically. But specifically I can't recall what 16 the reason was to look at the note. 17 Q. Well, can you think of a reason why you 18 would look at the op note as part of your post 19 complication care of the patient? 20 A. I really can't say what I was thinking 21 at that time. But I did continue to see the 22 patient, so I did continue to round on the 23 patient. 24 Q. Is it possible that you went back to 25 collect data about this patient to report to 0037 1 somebody else with respect to the complication he 2 experienced? 3 MS. CARULAS: Objection. 4 A. I can't say what I was doing at that 5 time. 6 Q. I'm going to hand you what I'll mark as 7 Exhibit 7. 8 (Deposition Exhibit 7 was marked for 9 purposes of identification.) 10 Q. Doctor, this is a two-page document that 11 purports to be a chest x-ray that was taken in 12 September of 2006, and it appears that you 13 reviewed this on June 3rd of 2008 at 6:27 p.m. 14 Can you tell us why you would have been 15 looking at that a couple of years after the 16 procedure? 17 A. I don't recall. 18 Q. Well, can we agree that you likely 19 wouldn't have been looking at it for clinical 20 reasons? 21 A. I don't recall. 22 Q. Was this patient the subject of any 23 research? 24 A. No. 25 Q. Well, then why would you be looking at 0038 1 this two years later? 2 A. I don't know. 3 Q. You can't furnish a single reason why 4 you would be looking at his record two years 5 after he stroked out after a PVAI ablation? 6 A. It would be hyperbole. 7 Q. Do you have records that reflect what 8 you were doing on June 3 of 2008? 9 A. Records as to what? 10 Q. Well, so that we can put this in context 11 so we can figure out why you were looking at 12 Shannon Sullivan's records two years after his 13 stroke. 14 A. All my activities are documented by the 15 Clinic. I don't recall what I was doing 16 specifically on June 3rd, 2008. 17 Q. Could we look at -- would there be 18 records of that activity? 19 A. As in -- I don't know what you mean by 20 the word "activity." 21 Q. Well, look, we want to know if this guy 22 was a subject of research activities. You were 23 looking at his chart two years after the stroke 24 occurred. There's obviously no clinical reason 25 why you would be looking at his record. 0039 1 I'm asking you, would there be any 2 documentation that would assist us in figuring 3 out why you were looking at his chart two years 4 after he stroked out following this procedure. 5 A. You would have to look at the records of 6 the Electrophysiology Department as to what I was 7 assigned to during those weeks. 8 Q. What kind of records would they look at? 9 What would they ask for? 10 A. Ask for the schedule. 11 Q. What kind of schedule? 12 A. What I was assigned to do at that time. 13 Q. And give me some more information. Your 14 schedule of what you were assigned to do in the 15 EP Department, and where would that be maintained 16 at? 17 A. I don't know. 18 Q. Is this something that you would write 19 and record and hand to somebody or is this 20 something that would be given to you? 21 A. It would be something given to me. 22 Q. And who would give that to you? 23 A. At the time it would have been either my 24 director or my chairman. 25 Q. Who was your director back then? 0040 1 A. In 2008? 2 Q. Yes, 2008, yes. 3 A. In 2008 it would have been Dr. Lindsay, 4 I believe. 5 Q. And who was the chairman in 2008? 6 A. That would be Dr. Lindsay. 7 Q. Who was the director? I'm sorry. 8 A. It's the same title. 9 Q. Okay. 10 MS. CARULAS: Want to take a break for a 11 minute? 12 THE WITNESS: Yeah. 13 MR. KULWICKI: Okay. 14 (A recess was taken.) 15 Q. Doctor, we have an audit trail that 16 shows that the pharmacy received orders from a 17 J. Cummings on June 12th, 2006, approximately two 18 months before the patient's PVAI ablation 19 procedure. 20 Do you have any recollection of giving 21 orders at that time? 22 A. No. 23 Q. Assuming that to be true, that this is 24 an accurate reflection of orders being given by 25 you to the pharmacy in June of 2006, why would it 0041 1 be that you would be involved with 2 Dr. Burkhardt's patient two months prior to the 3 surgery? 4 MS. CARULAS: Just note an objection. 5 Go ahead. 6 A. As I stated earlier, they have to place 7 the patient on assignment. I presume that it was 8 placed because the patient was to be assigned to 9 me when they got admitted, I would assume. 10 Q. I asked you if this patient was the 11 subject of any research and you said no. 12 How do you know that? How can you base 13 that on just looking at your couple of post-op -- 14 or post procedure records? 15 A. There is no documentation of any 16 research going on in my note, in the notes around 17 my note. 18 Q. Where would you look to see if this 19 patient was the subject of any study? 20 A. Well, Dr. Burkhardt's note following 21 mine. It would have been documented if he had 22 been. 23 Q. And where would it be documented at? 24 A. If he had been in research, it would 25 have been documented in the chart. 0042 1 Q. How so? How? 2 A. There would be a Research Consent Form, 3 there would be documentation of a CRF. 4 Q. I'm sorry, a C what? 5 A. A Case Review Form, I believe is what it 6 stands for. 7 Q. Are the existence of those records 8 documented -- were they documented in the EPIC 9 system back in 2006? 10 A. I don't know. 11 Q. In terms of the PVAI ablation procedure, 12 when it was done concomitantly with an SVC 13 procedure, how -- well, let me ask this a 14 different way. 15 Who trained you to do that procedure? 16 A. My attendings. 17 Q. And would those have been at the Clinic? 18 A. Yes. 19 Q. Would it have included Dr. Burkhardt? 20 A. Yes, for one year. 21 Q. Okay. And in terms of doing the dual 22 procedures, the superior vena cava ablation with 23 the PVAI ablation, were those done where the left 24 side of the heart was done manually and the right 25 side of the heart was done remotely ever? 0043 1 MS. CARULAS: Objection. 2 Q. You can answer. 3 A. I believe so. 4 Q. Did you ever do it that way? 5 MS. CARULAS: Objection. Go ahead. 6 A. I don't remember. 7 Q. Do you know if Dr. Burkhardt ever did it 8 that way? 9 A. You'll have to ask Dr. Burkhardt. 10 Q. I'm asking you if you know if he did. 11 A. I don't know. 12 Q. Can you think of any reason based on 13 your training and experience, particularly under 14 Dr. Burkhardt, why you would do one procedure, 15 the left side of the heart, do it manually, and 16 do the right side of the heart remotely? 17 MS. CARULAS: Note an objection. 18 Go ahead. 19 A. In 2006 I think that the catheters that 20 were used remotely were used on the right side of 21 the heart. 22 Q. And let me clear up what you're saying. 23 It's your understanding that the catheters that 24 were used remotely were used only on the right 25 side of the heart in 2006? 0044 1 A. I believe so. 2 Q. Was there any difference in terms of 3 relative risk or relative benefit to using the 8 4 millimeter catheters versus the 4 millimeter 5 catheters back in 2006? 6 A. Please define the 4 millimeter 7 catheters. There's two types. 8 Q. Well, let's talk about the closed-tip 9 one first. 10 A. We never used the 4 millimeter 11 closed-tip for left atrial ablation. 12 Q. Okay. What were the two different 13 4 millimeter catheters then? 14 A. Open irrigated and the closed, but we 15 didn't really use them very often for AF 16 ablation. 17 Q. Why not? 18 A. Ineffective. 19 Q. Was an 8 millimeter typically used? 20 A. I can't remember when we switched from 21 the 8 millimeter to the open irrigated catheter. 22 Q. Was that switch, as you call it, made by 23 some kind of directive from Dr. Natale or someone 24 else at the Clinic or was it a product of a 25 meeting amongst the EPs? 0045 1 How did that switch come to -- as you 2 say we made the decision to switch, how did that 3 decision come about? 4 A. The catheter is more effective and 5 safer, so when the literature came out to 6 document that, we switched. 7 Q. And how were you made aware of this 8 switch? 9 A. I read the literature that documented it 10 to be safer and I switched. 11 Q. Do you remember what literature you're 12 referring to? 13 A. No, I can't recite the citations for you 14 off the top of my head. I apologize. 15 Q. Do you remember who the principal 16 investigator was of that literature? 17 A. There were several articles that came 18 out at that time period describing the safety and 19 the efficacy of the open irrigated catheter. 20 Q. Would you have access to the substance 21 of those articles before they were formally 22 published in the sense of being at meetings or 23 knowing some of the principal investigators of 24 this equipment? 25 A. No. 0046 1 Q. And so we were talking about the 8 2 millimeter catheter. Who was the manufacturer of 3 that? 4 A. There are several 8 millimeter catheters 5 made by several companies. 6 Q. Okay. And you described that. Was that 7 an open tip catheter? 8 A. The 8 millimeter tip catheter? 9 Q. Yes. 10 A. No. 11 Q. And when we talked about the 4 12 millimeter catheter, is that the same as the 3.5 13 millimeter Biosense Celsius ThermoCool 14 irrigated-tip ablation catheter? 15 A. That is the open irrigated catheter. 16 Q. Okay. Is that the same as the 4 17 millimeter that we talked about? 18 A. Yes. 19 Q. I'm sorry? 20 A. Yes. 21 Q. Okay. Was the risk of stroke higher for 22 patients with persistent atrial fibrillation over 23 patients with peroxisomal fibrillation following 24 PVAI ablation? 25 A. I don't know the data. 0047 1 Q. Would you agree that some patients back 2 in 2006 had the expectation that after successful 3 A-fib ablation that they could stop taking their 4 anticoagulant drugs and that was well known to 5 physicians at The Cleveland Clinic? 6 A. Could you repeat the question, please? 7 I'm sorry. 8 Q. Sure. Would you agree that in 2006 that 9 it was known to physicians at the Clinic that 10 patients had the expectation that successful 11 ablation would allow them to stop taking 12 anticoagulant drugs? 13 MS. CARULAS: Objection. 14 A. I can't say what patients expected. 15 Q. Well, Doctor, you wrote in September of 16 2009, "Moreover, some patients may have 17 unrealistic expectations about it, such as being 18 able to stop taking anticoagulated drugs 19 afterwards." 20 Did you just forget what you wrote 21 today? 22 MS. CARULAS: Come on, Dave. 23 Number one -- 24 MR. KULWICKI: We're going to be here 25 for a while. 0048 1 MS. CARULAS: We're going to have to 2 stop this. Listen to me for a minute. She's 3 here as a fact witness to talk about her 4 involvement, okay. 5 Now, I've been really lenient with you 6 here, letting you ask her all kinds of questions 7 that has nothing to do with her involvement in 8 this matter. 9 Then you're asking her questions -- I 10 mean it's just -- the way you're doing this is so 11 inappropriate. 12 MR. KULWICKI: She's an employee of The 13 Cleveland Clinic at the relevant time. I can 14 pursue any discovery I want with respect to 15 policies and practices back then. 16 MS. CARULAS: Yeah, but do you 17 understand the way you just asked that question? 18 MR. KULWICKI: Did you hear how she 19 answered it? 20 MS. CARULAS: Come on. 21 MR. KULWICKI: I mean this is very 22 different from what she just said. The doctor is 23 telling me she doesn't know what patients expect 24 and then she just wrote patients have unrealistic 25 expectations. 0049 1 I mean let's get a straight answer here 2 and we can move along. So you want to go head to 3 head, we can go head to head. 4 MS. CARULAS: You bet you we can. 5 MR. KULWICKI: Let's do it. 6 MS. CARULAS: I mean if you want to show 7 her something. The way you asked that question, 8 I mean the tone of voice and the way you're 9 approaching this, we'll have to talk to the Judge 10 about it if you continue it. 11 MR. KULWICKI: That's fine. 12 Q. Doctor, can we agree that you knew in 13 2006 that some patients had an expectation that 14 with successful ablation for their A-fib that 15 they may be able to stop taking anticoagulant 16 drugs afterwards? 17 A. I agree that some patients have that 18 expectation. 19 Q. And that was known in 2006, true? 20 A. Yes. 21 Q. And would you agree that was not a 22 benefit of the procedure; in other words, that 23 patients following successful ablation would have 24 to continue taking their anticoagulant 25 medications for the remainder of their life? 0050 1 A. I don't understand your question. 2 Q. Back in 2006 was it understood that 3 patients who had a successful ablation for A-fib 4 would have to continue taking their 5 anticoagulation medications for the rest of their 6 life? 7 A. It depended on the patient's risk 8 profile. 9 Q. Okay. How about a patient who had 10 persistent A-fib? 11 A. In my practice, a persistent atrial 12 fibrillation patient, if they had a CHADS2 score 13 of 2 or higher, they remained on Coumadin. 14 Q. What about a patient who had a CHADS2 15 score of zero who had persistent A-fib? 16 A. Guidelines state that after the period 17 of time following the ablation they can go to 18 aspirin. The 2006 guidelines state that. 19 Q. Doctor, in September of 2009 you wrote, 20 Even after ablation, patients with atrial 21 fibrillation still face a formidable risk of 22 thromboembolic events and most 23 electrophysiologists suggest life-long 24 anticoagulation, especially in patients with 25 other risk factors for stroke. 0051 1 Is that what you wrote? 2 A. Yes. 3 Q. And do you agree with that today? 4 A. That's just what I stated. 5 Q. Okay. And in patients who had 6 unsuccessful catheter ablation; in other words, 7 patients who did not have their A-fib cured by 8 ablation, they would certainly have to continue 9 on anticoagulation, true? 10 A. If their CHADS2 score deemed them to be 11 on Coumadin. 12 Q. Okay. Even if they had persistent A-fib 13 in the face of a CHADS2 zero? 14 A. Guidelines state that CHADS2 zero, 15 regardless of peroxisomal versus persistent, are 16 sufficient on aspirin. 17 Q. In 2006 was it the case that patients 18 with a CHADS2 score of zero but with persistent 19 atrial fibrillation should take warfarin or 20 Coumadin for at least three weeks before 21 undergoing ablation? 22 A. Yes. 23 Q. And the type -- I'm sorry, the target 24 INR is in the therapeutic range of 2 to 3 for 25 such patients? 0052 1 A. Yes. 2 Q. And that patients who have been taking 3 warfarin before the procedure should be bridged 4 with subcu low-molecular-weight heparin or 5 intravenous unfractionated heparin before 6 ablation by stopping the warfarin several days 7 before the procedure and substituting Lovenox 8 twice daily until the evening before the 9 procedure? 10 A. In 2006? 11 Q. Yes. 12 A. I believe that's what we were doing. 13 Q. And, Doctor, as recently as September of 14 2009 you wrote, We still lack large-scale trials 15 about long-term thromboembolic complications of 16 ablation therapy. Most electrophysiologists 17 prefer to continue anticoagulation indefinitely 18 and would consider terminating it only with great 19 caution. 20 Would you agree with that? 21 A. Yes. 22 Q. Was it any different back in 2006? 23 A. No. 24 Q. Doctor, the audit trail also shows that 25 on July 31, 2006 at 8:35 a.m. that you accessed 0053 1 Mr. Sullivan's chart and entered an encounter and 2 also something with respect to imaging. 3 And I only have this electronically. 4 It was highlighted. But if you look there, tell 5 me when you see that. 6 (A pause was taken.) 7 MS. CARULAS: Are you talking about the 8 one for Ardelle Cummings? 9 Q. That's not you? 10 A. No, my name is Jennifer. 11 MS. MAHON: Oh, I made a mistake. 12 MS. CARULAS: I think that was the 13 reference you made to a Cummings earlier. 14 MR. KULWICKI: I think it was 15 J. Cummings. 16 MS. MAHON: There's a different report. 17 Actually there's a different page that says they 18 review orders from pharmacy, but I'll find it. 19 MR. KULWICKI: All right. 20 Q. Okay. Doctor, I want to hand you what 21 I'll mark as Exhibit 8. 22 (Deposition Exhibit 8 was marked for 23 purposes of identification.) 24 Q. This is 14 pages and this is from the 25 procedure note for Mr. Sullivan and I want to ask 0054 1 you generally with respect to the types of 2 records that were kept back in 2006 with respect 3 to this type of procedure, whether this would be 4 a complete set of documentation from that 5 procedure, and from the standpoint of recording 6 the procedure itself. 7 The first item in Exhibit 8 is the 8 operative note that we talked about earlier, the 9 next item is a three-page sedation record, the 10 fifth page is a procedural sedation additional 11 monitoring record that goes two pages, and then 12 the remainder of it is the cardiac 13 electrophysiology report. 14 What I want to ask you, Doctor, is from 15 a procedure, a PVAI ablation procedure, is there 16 any other documentation that's generated as a 17 routine matter as part of that procedure back at 18 the Clinic in 2006? 19 MS. CARULAS: Objection. If you 20 remember what the exact records were. 21 A. I don't remember all of the paper and 22 records that were generated at the end of the 23 procedure, but this is the EPIC procedure and 24 that's transferred later from the database 25 report. So I believe there may be another op 0055 1 report that's placed in the chart at the time of 2 the procedure. 3 Q. And when you say from a database report, 4 what are you talking about? I'm not familiar 5 with that term. 6 A. We generate a report at the end of the 7 procedure. 8 Q. And is that something that's typed into 9 EPIC by the surgeon? 10 A. No. 11 Q. How is it put into the database? 12 A. It's typed into the computer and the 13 computer sends it to EPIC. 14 Q. And who types it in? 15 A. The physician who performed the 16 procedure. It's these words, but this is not 17 available immediately so it's typed separately. 18 So I believe there's a separate op note. 19 Q. Okay. So what you're talking about is 20 the first two pages, the narrative with respect 21 to the procedure, that is typed in after the 22 procedure and then it comes out in the format of 23 what we have here? 24 A. There should be two op notes, I believe. 25 If I remember at that time, we were unable to 0056 1 type into EPIC directly op notes. They were 2 transferred from one system to another. So 3 because it was important that the patient have an 4 op note at the time they went to the floor, two 5 op notes should be in the chart. I don't know if 6 there is one in this case, but if I remember back 7 in 2006 there should be two op notes. 8 The text should be the same. It's the 9 same text. It's just what's available. 10 Q. Besides the other op note that you've 11 referenced, anything else that would typically be 12 part of the procedural record for a PVAI ablation 13 with an SVC ablation? 14 A. I can't think of anything on the record 15 right now. 16 Q. In terms of imaging, we were provided 17 with images - and I can show them to you if you 18 want - of fluoroscopy that was performed 19 intraoperatively relative to only the SVC portion 20 of the procedure and also a single sort of 21 snapshot in time from an ICE study. 22 Besides that imaging, is there any other 23 intraoperative imaging or software images that 24 you recall would be maintained as part of the 25 record or as part of the patient's file for this 0057 1 type of procedure? 2 A. It would depend on the imaging saved on 3 the computer. 4 Q. Okay. Now, I know that -- 5 A. Those are the typical things that are 6 saved that you stated. 7 Q. How about with respect to the 8 intracardiac ultrasound, the ICE monitoring; were 9 there images from that typically saved? 10 A. No. 11 Q. Was there any record made of those 12 images ever? 13 A. I don't know if they were transferred to 14 the permanent database. I don't know to be 15 honest with you. 16 Q. And by permanent database, what are you 17 referring to? 18 A. I would presume you're asking if there's 19 echo images in an echo database. I don't know. 20 Q. Okay. 21 A. We did not consciously store echo 22 images. 23 Q. With respect to the esophageal 24 temperature probe, was there any record made of 25 the readings from that device during this type of 0058 1 procedure? 2 A. I don't know if we were doing esophageal 3 temperature probes in 2006. I don't remember. 4 Typically they would be marked down by the nurses 5 in the nurses notes. 6 Q. And by the nurses notes, are you talking 7 about the procedural nurses notes? 8 A. Yes. 9 Q. Is that what's called the procedural 10 sedation additional monitoring record? 11 A. Yes. 12 Q. Mr. Sullivan recalls swallowing what was 13 called a pill camera prior to this procedure. 14 Does that sound like an esophageal probe? 15 A. At the time of the procedure? 16 Q. Yes. 17 A. It sounds like it. It's stated here 18 temperature probe placed. 19 Q. And where are you referring to? 20 A. On your Exhibit 8, it would be page 5. 21 Q. What would be the purpose in placing the 22 probe towards the end of the procedure? 23 A. I believe that's the beginning of the 24 procedure, sir. 25 Q. Do you see anywhere where any records 0059 1 are made of the readings from that probe? 2 MS. CARULAS: Again, I mean she is not 3 the right person to ask here. Obviously you 4 should be asking Dr. Burkhardt that. 5 A. I don't see any in front of me. 6 Q. Was it standard practice back in 2006 to 7 record any of the readings from the esophageal 8 temperature probe -- 9 MS. CARULAS: Objection. 10 Q. -- at the Clinic? 11 A. I don't recall what we were doing in 12 2006 and where they were recorded. I know where 13 I recorded them in mine, but I don't know where 14 they were recorded. 15 Q. And where would you record them at? 16 A. I think in many of my procedures they 17 were recorded in the nurses note or I would 18 verbalize them and they would be documented in 19 the records. 20 Q. In terms of when this procedure is 21 performed, typically what were the sort of 22 standard personnel that would be present during 23 the procedure? 24 A. The attending physician, the fellow, the 25 nurse at the head of the bed, the nurse at the 0060 1 ablation and the circulating nurse. 2 Q. Would it be the same personnel if it was 3 done remotely? 4 A. Yes. 5 Q. Was it appreciated back in 2006 that the 6 extensiveness of the ablation, in other words, 7 the number of ablations that were performed and 8 the area being ablated, the more ablations, the 9 more area ablated, the extent of the ablation 10 would increase the risk of thrombus formation? 11 A. I don't know data that would directly 12 correlate the two. 13 Q. Would you agree that operator 14 inexperience increased the risk of complication 15 from PVAI ablation? 16 A. Yes. 17 Q. And that was known in August of 2006, 18 true? 19 A. I believe so. 20 Q. In order to assess whether the patient 21 sustained an esophageal injury as part of the 22 PVAI ablation, would you look at the chest x-ray? 23 Is that where you would look? 24 A. Excuse me? 25 Q. If you were looking for evidence of an 0061 1 esophageal injury caused during a PVAI ablation, 2 would you look at a chest x-ray for evidence of 3 that esophageal injury? Is that where you would 4 look? 5 A. No. 6 Q. Can we agree that a severe headache post 7 PVAI ablation procedure is a potential sign or 8 symptom of stroke? 9 A. Excuse me? 10 Q. Can we agree that a severe headache 11 following a PVAI ablation is a potential sign or 12 symptom of a stroke? 13 MS. CARULAS: Objection. 14 A. I have not heard of a headache being 15 used as the primary symptom of a stroke, no. 16 Q. Is a severe headache a sign or symptom 17 -- or a common finding in post PVAI ablation 18 patients undergoing conscious sedation? 19 A. Some patients undergoing conscious 20 sedation have headaches. 21 Q. Severe headaches? 22 A. They have headaches. 23 Q. Would a severe headache be a concerning 24 sign or symptom in a post PVAI ablation patient? 25 MS. CARULAS: Objection. 0062 1 A. It would be more concerning of a bleed, 2 not a stroke. 3 Q. Of intracerebral bleed? 4 A. I suppose, but headache -- 5 Q. Well, that is a stroke, isn't it? 6 A. No. 7 Q. How would that be different from the 8 hemorrhagic stroke? 9 A. I don't think they're the same. You'll 10 have to ask a neurologist. But they're treated 11 differently. 12 Q. How do you evaluate a patient for an 13 intracerebral bleed post PVAI ablation? 14 MS. CARULAS: Objection. 15 A. How do we examine them to see if they 16 have one? 17 Q. Yes. 18 A. You do neuro checks. 19 Q. Okay. That would be the standard of 20 care in 2006? 21 A. Neuro checks, yes. 22 Q. Are you aware of any respect in which 23 Shannon Sullivan's care fell below accepted 24 standards of medical care? 25 A. No. 0063 1 Q. Do you know if his bad outcome, his 2 adverse outcome, was something that would be 3 reported to the MOD database? 4 A. I don't know of the MOD database. 5 Q. Do you know if it's something that would 6 be reported to JCAHO by Clinic protocols? 7 MS. CARULAS: Objection. 8 A. Not that I know of. 9 Q. Do you know if it is something that 10 would be reported within the EP community at The 11 Cleveland Clinic to other EPs? 12 MS. CARULAS: Objection. 13 A. No. 14 Q. Okay. Well -- 15 MS. CARULAS: Do you mean informally 16 that Dr. Burkhardt would say to others in this 17 particular case or are you saying some kind of a 18 formal -- 19 MR. KULWICKI: Let me clarify. 20 Q. Was there any formal mechanism at The 21 Cleveland Clinic back in 2006 by which adverse 22 outcomes from EP procedures were related to other 23 electrophysiologists in the electrophysiology 24 unit by way of education, experience, et cetera, 25 training and ongoing information, to bring to 0064 1 their attention an adverse consequence of a 2 particular procedure? 3 MS. CARULAS: Objection. 4 A. The standard protocol to complications 5 would be in the form of a morbidity and 6 mortality. 7 Q. And would the morbidity and mortality 8 reporting be something that would be shared with 9 the other EPs in the department? 10 MS. CARULAS: Objection. 11 A. Morbidity and mortality meeting is by 12 definition morbidity and mortality meeting. 13 Reports of those are not dispersed. 14 Is that what you're asking? 15 Q. I guess I'm asking -- it seems to me 16 you've got this unique facility in the Clinic and 17 you're doing some cutting-edge stuff and you've 18 got a lot of people investigating a lot of 19 different things and you have the worst case 20 scenario develop here with Shannon Sullivan, and 21 it seems to me like being a rational and 22 legitimate business, you would want everybody to 23 know about it and everybody to talk about it to 24 try to figure out, hmmm, what went wrong here. 25 Are you telling me nothing like that 0065 1 happens? 2 MS. CARULAS: Objection. We're not 3 going to get into obviously anything about an 4 M&M. 5 MR. KULWICKI: I'm talking about the 6 adverse event itself. I'm not talking about what 7 was done as a result of that. I'm asking whether 8 the adverse event itself was communicated amongst 9 the EPs in the department. 10 A. Adverse events are discussed in the form 11 of morbidity and mortality. That's the format 12 they're discussed with the department. 13 Q. Okay. Do you know if adverse events 14 like Mr. Sullivan's were reported in any fashion 15 to device manufacturers such as the manufacturer 16 of the catheters that were used in this 17 procedure? 18 MS. CARULAS: Objection. 19 A. I have no knowledge of those kind of 20 reports. 21 Q. And was there any reporting of adverse 22 events to supervisors like Dr. Natale on a 23 regular basis? 24 A. In the form of an M&M. 25 Q. Have you ever had an opportunity to 0066 1 review an electronic medical record like the EPIC 2 system in a printed-out version as opposed to 3 looking at it electronically or in an electronic 4 format? 5 MS. CARULAS: Are you talking how I 6 showed her the records in a printed format? 7 MR. KULWICKI: Well, I don't know what 8 you showed her. 9 MS. CARULAS: What you're showing her 10 now? 11 A. Yes, now that you've shown me, yes. 12 Q. Can we agree that the EMR is meant to be 13 viewed in an electronic format? 14 A. I don't understand your question. 15 Q. Well, it's an electronic medical record. 16 Is your training in using that electronic medical 17 record such that you normally in the course of 18 your practice look at it in an electronic format 19 as opposed to a printed-out format? 20 A. I would presume by definition electronic 21 medical record would be looked at electronically. 22 Q. Are fellows in the EP Department in 2006 23 required to maintain a surgical log? 24 A. There is a log of all their procedures, 25 yes. 0067 1 Q. And does the fellow prepare that or is 2 the attending that they're assigned to for a 3 particular procedure the one who fills that out, 4 or both? 5 A. The log of every procedure a fellow 6 performs is kept electronically. 7 Q. Well, who prepares that? Who enters the 8 information into the log? 9 A. When you create your report and, as you 10 stated here, how you know what physician did it, 11 and that's the electronic record on the 12 physician. And then it states who did the 13 procedure, the lab staff, David Burkhardt in this 14 case; lab fellow, Mohamed Kanj. It tells you who 15 sent the patient. That is your log. 16 Q. Is there a report or a place to compile 17 for like, say, Dr. Kanj, to find all of the 18 procedures that he, himself performed? You know, 19 is there some way to look at all the procedures 20 he did as opposed to going report by report by 21 report? 22 A. I don't know what system they have right 23 now. I think they've changed. So I don't know 24 how Dr. Kanj looks at his records. 25 MS. CARULAS: You can ask him Monday. 0068 1 Q. Have you ever heard of a thing called a 2 surgical log? 3 A. I keep track of my procedures. 4 Q. Okay. And you keep track of them 5 outside of the setting of the operative note 6 itself, true? 7 A. No, actually at The Cleveland Clinic 8 everything is documented together. You can -- 9 I believe you can go to EPIC and find the 10 physicians that do the procedures, I would 11 presume. I've never searched for anybody's 12 procedures before. 13 Q. I think we got sidetracked when we 14 started talking about the risks and benefits of 15 different types of catheters that were 16 appreciated and understood back in August of 2006 17 by the Clinic's EP Department. 18 What are the relative risks and benefits 19 of using the irrigated-tip catheters versus 20 closed-tip catheters? 21 MS. CARULAS: Objection. Go ahead. 22 A. There's some data to state that 23 irrigated tips are less likely to form clotted 24 char and less likely to lead to stroke. I don't 25 know when that data came out. 0069 1 Q. Would you agree that Protamine has a 2 potential to be prothrombogenic? 3 A. Protamine reverses heparin. 4 Q. Do you consider it to be a 5 prothrombogenic drug? 6 A. It reverses heparin but it doesn't take 7 it beyond -- it's not procoagulant. It reverses 8 the anticoagulation. 9 Q. In the course of performing a PVAI 10 ablation, it's my understanding that the catheter 11 is threaded from the right side of the heart, 12 through the septum, into the left side of the 13 heart to isolate the pulmonary veins. 14 A. Yes. 15 Q. How is the hole in the septum repaired 16 after that procedure is done? 17 A. Data shows the hole closes on its own 18 after time. 19 Q. Is there any -- well, in terms of your 20 training, particularly under Dr. Burkhardt, were 21 you trained when you did a PVAI ablation in 22 conjunction with an SVC ablation to do the left 23 side first and then the right side, or vice 24 versa? 25 A. Left side first. 0070 1 Q. And why was that? 2 A. It's the high-risk portion. 3 Q. Would you agree that it would be 4 incorrect to tell a patient with persistent A-fib 5 that their success rate was the same as a patient 6 with peroxisomal A-fib? 7 MS. CARULAS: Objection. I think you 8 asked the same question about -- in a different 9 way, whether there were different efficacies for 10 the two. 11 A. As I stated previously, efficacy is less 12 for persistent. 13 Q. Would it be incorrect to tell a patient 14 who was undergoing PVAI ablation for persistent 15 A-fib that they will only need anticoagulants for 16 three months following the procedure without 17 knowing the results of the procedure? 18 A. It would depend on the CHADS2 score of 19 the patient. 20 Q. Is there a difference between the 21 success rate for keyhole Maze procedure and PVAI 22 ablation when treating persistent A-fib? 23 A. I don't know the success rate for the 24 keyhole Maze procedure. 25 Q. Do you do that procedure? 0071 1 A. No. 2 Q. What specialty of medicine does that 3 procedure? 4 A. Cardiothoracic surgery. 5 Q. How do you discuss with your PVAI 6 ablation patients the option of undergoing a 7 keyhole Maze if you don't know the likely success 8 of that or know the risks and benefits of that 9 procedure? 10 MS. CARULAS: Objection. 11 A. In my practice I state if they're 12 interested in a Maze procedure, keyhole or 13 otherwise, I put them in contact with a surgeon 14 who does it and they meet with them to discuss 15 the risks and benefits. 16 Q. Would you agree that the PVAI ablation 17 procedure typically takes three to five hours? 18 MS. CARULAS: Are you quoting from her 19 article again? 20 Q. Yes. 21 A. Yes. 22 Q. And would you agree that the longer the 23 procedural time, being an instrumented procedure, 24 the greater the likelihood of stroke? 25 A. I'm not sure if the data supports a 0072 1 direct relationship between length of procedure 2 and thrombus and stroke. 3 Q. Just understanding how the procedure was 4 done by The Cleveland Clinic's EP lab back in 5 2006, if hypothetically the right side of the 6 heart -- or left side of the heart was done 7 manually and the right side done remotely, would 8 there have to be removal of sheaths when changing 9 the catheters? 10 MS. CARULAS: Objection. 11 A. I don't think so but I don't remember. 12 Q. Is there any benefit to the patient that 13 you can think of in doing the left side of the 14 heart manually and the right side remotely? 15 MS. CARULAS: Objection. 16 A. Remote navigation has been shown to be 17 safer in some situations and in other situations 18 not, so there are some reasons to divide up by 19 catheter type. In 2006 the open irrigated 20 catheter was not available for remote navigation. 21 Q. And so in a setting like this, can you 22 think of any reason why going from manual on the 23 left side to remote on the right side would have 24 a benefit for the patient? 25 MS. CARULAS: Objection. 0073 1 A. You'll have to ask Dr. Burkhardt why he 2 chose to do that on this patient. I make my 3 decisions in the operating room with each 4 patient. Some patients I choose to do something. 5 You can ask him. 6 Q. How is the energy initiated? Is it via 7 a foot pedal? 8 A. No. 9 Q. How is it done? 10 A. There is a button that is on a generator 11 that is hit. 12 Q. And were you aware in 2006 of any 13 defective equipment that either delivered energy 14 unevenly or that failed to stop delivering energy 15 when this button or whatever it was that 16 initiated the energy was disengaged? 17 MS. CARULAS: Objection. 18 A. I was not aware of any. 19 Q. Based on your training under 20 Dr. Burkhardt, was it his practice to not give 21 the patient Lovenox post procedurally until 22 several hours after the procedure? 23 A. The Lovenox is given as a twice a day 24 dose, so it would be given when they returned to 25 the floor in a time that was safe. 0074 1 Q. And if there was a delay in returning 2 the patient to the floor, what would be a safe 3 period of time to delay giving the Lovenox? 4 MS. CARULAS: Objection. Go ahead. 5 A. There are concerns about bleeding from 6 removal of the sheaths, so if an individual were 7 having a significant bleeding, bruising or -- 8 there's many situations that you would delay the 9 Lovenox because of those kind of situations. 10 Q. Let's say the patient wasn't having 11 bleeding or bruising. What other reasons might 12 there be for delaying the Lovenox? 13 MS. CARULAS: And what do you consider 14 delay? 15 MR. KULWICKI: Well, that would be the 16 next question. I mean I'll take these piece by 17 piece. 18 MS. CARULAS: Objection. 19 A. The original time that we preferred 20 would be to start the next morning. 21 Q. The Lovenox? 22 A. Correct. 23 Q. Okay. 24 A. However, we started doing it earlier as 25 twice a day for 10 p.m. and 10 a.m. 0075 1 Q. Understanding that most of the 2 procedures would be started mid morning and end 3 mid afternoon? 4 A. It would depend on when the patient -- 5 if a patient was finished off cycle, that could 6 be addressed at a different time. 7 MR. KULWICKI: I think I'm either done 8 or close to done. Give me five minutes to 9 regroup and I'm going to come back and we'll wrap 10 it up. 11 (A recess was taken.) 12 MR. KULWICKI: Okay. We're done. Thank 13 you. 14 MS. CARULAS: All right. You have the 15 right to read over the transcript and I always 16 recommend that. So we won't waive signature. 17 18 (Deposition concluded at 6:54 p.m.) 19 - - - - - 20 21 22 23 24 25 0076 1 CERTIFICATE 2 3 The State of Ohio, ) 4 ) SS: 5 County of Cuyahoga. ) 6 7 I, Christine Leisure, a Notary Public within and for the State of Ohio, duly 8 commissioned and qualified, do hereby certify that the within named witness, JENNIFER E. 9 CUMMINGS, M.D., was by me first duly sworn to testify the truth, the whole truth and nothing 10 but the truth in the cause aforesaid; that the testimony then given by the above-referenced 11 witness was by me reduced to stenotypy in the presence of said witness; afterwards transcribed, 12 and that the foregoing is a true and correct transcription of the testimony so given by the 13 above-referenced witness. 14 I do further certify that this deposition was taken at the time and place in the 15 foregoing caption specified and was completed without adjournment. I do further certify that I 16 am not a relative, counsel or attorney for either party, or otherwise interested in the event of 17 this action. 18 IN WITNESS WHEREOF, I have hereunto set my hand and affixed my seal of office at 19 Cleveland, Ohio, on this _______ day of ___________________________ , 2010. 20 21 22 23 _______________________________________ Christine Leisure, Notary Public 24 within and for the State of Ohio 25 My commission expires April 21, 2012 0077 1 AFFIDAVIT OF NOTARY PUBLIC 2 3 The State of Ohio, ) 4 ) SS: 5 County of Cuyahoga. ) 6 7 Before me, a Notary Public in and for said 8 County and State, personally appeared JENNIFER E. 9 CUMMINGS, M.D., who acknowledged that she did 10 read her transcript in the above-captioned 11 matter, listed any necessary corrections on the 12 accompanying errata sheet, and did sign the 13 foregoing sworn statement and that the same is 14 her free act and deed. 15 In TESTIMONY WHEREOF, I have hereunto 16 affixed my name and official seal at this______ 17 day of _____________________ A.D. 2010. 18 19 20 ________________________ 21 Notary Public 22 23 _________________________ 24 My Commission Expires: 25 0078 1 SIGNATURE PAGE 2 3 Re: Shannon Sullivan, et al. vs. The 4 Cleveland Clinic Foundation 5 Case Number: CV-09-697617 6 Deponent: Jennifer E. Cummings, M.D. 7 Deposition Date: April 8, 2010 8 9 To the Reporter: 10 11 I have read the entire transcript of my 12 Deposition taken in the captioned matter or the 13 same has been read to me. I request that the 14 following changes be entered upon the record for 15 the reasons indicated. I have signed my name to 16 the Errata Sheet and the appropriate Certificate 17 and authorize you to attach both to the original 18 transcript. 19 20 21 22 23 _________________________________ 24 Jennifer E. Cummings, M.D. 25 0079 1 ERRATA SHEET 2 Page Line Change 3 _____ _____ _________________________________ 4 _____ _____ _________________________________ 5 _____ _____ _________________________________ 6 _____ _____ _________________________________ 7 _____ _____ _________________________________ 8 _____ _____ _________________________________ 9 _____ _____ _________________________________ 10 _____ _____ _________________________________ 11 _____ _____ _________________________________ 12 _____ _____ _________________________________ 13 _____ _____ _________________________________ 14 _____ _____ _________________________________ 15 _____ _____ _________________________________ 16 _____ _____ _________________________________ 17 _____ _____ _________________________________ 18 _____ _____ _________________________________ 19 _____ _____ _________________________________ 20 _____ _____ _________________________________ 21 _____ _____ _________________________________ 22 _____ _____ _________________________________ 23 _____ _____ _________________________________ 24 _____ NO CHANGES 25 Signature:_________________________ Date:________