0001
 1                   CUYAHOGA COUNTY, OHIO
                     COURT OF COMMON PLEAS
 2   
     ----------------------------x
 3   SHANNON SULLIVAN, et al.
 4            -against-                 CASE NO.
 5                                      CV-09-697617
 6   CLEVELAND CLINIC
 7   FOUNDATION
 8   ----------------------------x
 9   
10                       26 Court Street
11                       Brooklyn, New York
12                       March 29, 2011
13                       11:54 a.m.
14   
15   
16             EXAMINATION BEFORE TRIAL of
17   STEVEN RICHARD LEVINE, M.D. on behalf
18   of the plaintiff in the above-entitled
19   action, held at the above-mentioned
20   time and place, before Yvette Mosley
21   a Court Reporter within and for the
22   State of New York.
23   
24   
25   
0002
 1   A P P E A R A N C E S:
 2   
 3             BECKER & MISHKIND CO., L.P.A.
 4                  Attorneys for Plaintiff
 5                  1660 West Second Street
 6                  Suite 660
 7                  Cleveland, Ohio   44113
 8             BY:  DAVID A. KULWICKI, ESQ.
 9   
10             ROETZEL & ANDRESS
11                  Attorneys for Defendant
12                  1375 East Ninth Street
13                  Ninth Floor
14                  Cleveland, Ohio  44114
15             BY:  ANNA MOORE CARULAS, ESQ.
16   
17   
18   
19   
20   
21   
22   
23   
24   
25   
0003
 1   S T E V E N    R I C H A R D    L E V I N E ,  M.  D.,
 2             appearing as an expert witness, having been
 3             first duly affirmed by a Notary Public
 4             within and for the State of New York, was
 5             examined and testified as follows:
 6   EXAMINATION BY
 7   MS. CARULAS:
 8        Q    Would you please state your full name for
 9   the record?
10        A    Steven with a V Richard Levine, L-E-V-I-N-E.
11        Q    Dr. Levine, we've been introduced.  My name
12   is Anna Carulas, and I represent the Cleveland Clinic
13   in the lawsuit that has been brought by Shannon
14   Sullivan and his wife.
15        A    Okay.
16        Q    And you have been identified as an expert
17   witness on behalf of the plaintiff, is that correct?
18        A    Yes.
19        Q    Now, you authored a report in this case
20   which is dated August 6, 2010.
21        A    Okay.
22        Q    Is that the only report you have written in
23   this case?
24        A    Yes.
25        Q    Have you written any other documents
0004
 1   relative to this case?
 2        A    No.
 3        Q    You have with you here your file?
 4        A    Except for the records which were very
 5   hard -- large, heavy binders that I had asked the
 6   attorney if I had to bring; he fell it wasn't
 7   necessary.
 8        Q    Okay.
 9             So the records that you didn't bring are
10   Cleveland Clinic records, correct?
11        A    Correct, and I think some Hawaii records as
12   well.
13        Q    Okay.
14             I know in your report -- and do you have a
15   copy to follow along with or not?
16        A    No.  I figured somebody would bring a copy.
17                  MR. KULWICKI:  This is
18        actually the original, I guess.  It
19        looks like your original signature.
20                  THE WITNESS:  Yes, on a
21        colored letterhead.
22        Q    You have listed there Cleveland Clinic
23   records and then I think some Hawaii records for after
24   this stroke?
25        A    Right.
0005
 1        Q    Do you believe that's the extent of the
 2   records that you've reviewed in this case?
 3        A    I believe so.  I don't think I've gotten any
 4   new records since that time.
 5        Q    Okay.
 6        A    That I could recall.
 7        Q    And have you reviewed any of the records
 8   from before Mr. Sullivan came to the Cleveland Clinic?
 9        A    I think so, yeah.  There are some Hawaii
10   records as well.
11        Q    Okay.
12        A    That were in there as well.
13        Q    It looks like the --
14        A    It wasn't listed or?
15        Q    The records you listed here appear to be
16   from your report, six, seven, eight and nine all
17   appear to be subsequent treating records, and I didn't
18   see any records of any of the physicians prior to
19   coming to the Cleveland Clinic and was curious if
20   you've reviewed those?
21        A    I thought I did.  I thought I had seen
22   records like that.  Here, Queens Medical Center Hawaii
23   medical records.
24        Q    Okay.
25             Those are from the dates here all after the
0006
 1   stroke?
 2        A    That was Cleveland Clinic medical records,
 3   and then I put Queens Medical Center Hawaii.  So I
 4   think that may have been -- I don't know.  I can't
 5   recall off the top of my head if that was before or
 6   after.  If it was after then -- but I did recall
 7   seeing some office visits before.
 8        Q    Okay.
 9             The Queens medical records are actually from
10   after.
11        A    Okay, fine.
12        Q    As you sit here today can you remember the
13   names of any of his physicians prior to coming to the
14   Cleveland Clinic?
15        A    No, I don't.
16        Q    And do you remember the substance of the
17   type of doctors he went to see or the nature of any of
18   the visits prior to coming to Cleveland Clinic?
19        A    I think he saw maybe his internist or
20   cardiologist about his A-Fib and his treatment.  And I
21   think he had back pain or something and maybe that was
22   also something related to seeing some orthopedist or
23   something related to back pain, but nothing that
24   strikes me as that clear.
25        Q    Are your opinions, in any way, predicated
0007
 1   upon any records coming prior to coming to the
 2   Cleveland Clinic?
 3        A    No, I don't think so.
 4        Q    And I know you in looking at your --
 5             Are you going to add something?
 6        A    Well, I mean the issue is, you know, I think
 7   it wasn't clear to me -- I mean, he had been off his
 8   Coumadin for awhile.  And so what wasn't clearly -- I
 9   don't know if I put that in my report or not -- but,
10   you know, was Cleveland Clinic quarterbacking it or
11   was his Hawaii doctors quarterbacking, you know, how
12   long and what should to do with his Coumadin before he
13   was coming to the Cleveland Clinic.
14        Q    Okay.   I didn't see that specifically in
15   your --
16        A    Right, I know, I know.  Just in terms of
17   thinking back on, you know, the fact that he was off
18   it for awhile.
19        Q    Okay.
20             And so my question to you is -- since you
21   didn't bring your records here with you, and I
22   understand the logistics of carrying things.  Do you
23   have any cover letters at all that Mr. Kulwicki sent
24   you materials?
25        A    I assume that, yeah, they came with cover
0008
 1   letters.  Sure.
 2        Q    Would you have discarded those?  I don't see
 3   them here in your file.
 4        A    No, I don't think I discarded them.
 5        Q    Would they be back at home?
 6        A    Probably, yeah.
 7        Q    Okay.
 8        A    They just say, you know, Please find
 9   enclosed whatever was coming in.
10        Q    Okay.
11             And part of the difficulty here is I had
12   asked for your entire file to come --
13        A    You did?
14        Q    -- and so that would maybe --
15        A    Did I see that?
16        Q    Well, I sent it to Mr. Kulwicki, but --
17                  MR. KULWICKI:  I didn't send
18        it to you.
19        A    Yeah, because if I was required to bring it
20   all then, you know, I would have.  But we had talked
21   he said he didn't think it was necessary.
22        Q    Okay.
23        A    I would have taken a cab or something
24   instead of taking the train.
25        Q    Okay.
0009
 1             Maybe what you could do is afterward you
 2   could get me a copy of your transmittal letters.
 3        A    Sure.
 4        Q    And then that way you can determine what it
 5   is that you have reviewed prior to this.
 6        A    Okay.  I'm happy to send you the whole file
 7   by a box or something if you need that.
 8        Q    Yeah, I don't mean all the big records.
 9        A    Okay.
10        Q    But just because I'm trying to put through
11   here to know what you looked at prior to that.
12        A    Sure.
13        Q    Okay.
14             So in looking at this we know, number one,
15   you say you reviewed pertinent CCF records?
16        A    Right.
17        Q    Then you reviewed the actual CDs after the
18   stroke --
19        A    Right.
20        Q    -- of the head?  Okay.
21             And initially was one of the questions
22   raised to you in this case whether or not something
23   could have been done for the stroke --
24        A    Yes.
25        Q    -- after it happened?
0010
 1        A    Correct.
 2        Q    And when you were contacted in this case --
 3   first of all, do you remember who it was who contacted
 4   you initially?
 5        A    I'm not sure.  Might have been Attorney
 6   Kulwicki, but I can't recall off the top of my head.
 7        Q    Do you know whether you've spoken with
 8   anyone in this case other than Mr. Kulwicki?
 9        A    I mean it's possible I just don't remember
10   going back that far.
11        Q    But when you were first contacted, was the
12   primary inquiry to you the issue of whether or not
13   something could have been done for the stroke?
14        A    I believe so.  Sort of why he stroked, what
15   was the mechanism, could something have been done,
16   those sorts of the things related to stroke treatment
17   which is what I do.
18        Q    And it's my understanding, I guess based on
19   lack of a comment in that regard, that you had no
20   criticisms at all of the management of the stroke once
21   it happened?
22        A    Correct.
23        Q    All right.
24             So then at some point in time you were sent
25   the deposition of Dr. Burkhardt?
0011
 1        A    Correct.
 2        Q    With exhibits?
 3        A    Right.
 4        Q    And you do have that in here with you
 5   somewhere?
 6        A    Um-hum.
 7        Q    And as I look at the deposition I was
 8   curious just if you had stickied (sic) or highlighted
 9   anything?
10        A    No.  If I had highlighted anything I would
11   have turned the page up and circled or underlined
12   something.
13        Q    Okay.
14        A    Or made a comment, but I don't think I did
15   on his depo.  Maybe one.
16        Q    I thought I saw one.
17        A    Maybe one.
18                  MS. CARULAS:  Off the record.
19                  (Discussion held off the
20        record.)
21        Q    A couple writings here, is this your writing
22   here (indicating)?
23        A    Probably, yeah.
24        Q    So just for the record it looks like the
25   only marks you had was on Page 181 of Dr. Burkhardt's
0012
 1   deposition, and you underlined Line 10 the section
 2   that says:
 3                  I recall he would have been a candidate
 4        for...
 5             And then you highlighted the Yes of Line 14,
 6   and then the answer on Line 16.
 7             Any particular reason; do you know?
 8        A    Let me see what context it's in.
 9        Q    Sure (handing).
10        A    (Witness perusing document.)
11             Yeah.  I guess I was a little concerned
12   because he had had a bunch of stuff done that was
13   really experimental and so he really was enrolled in
14   studies in sort of a funky kind of way in that they
15   were gathering data on him, but then the issue is, you
16   know, where is there a written consent for doing
17   things that were really not part of standard of care.
18   So I think that's why I underlined that.
19             That there was an issue about -- the context
20   is, Was he enrolled in any specific studies?  And the
21   answer was, I recall he wouldn't have been a candidate
22   for it.  And the reason was raised, Because of
23   persistent A-Fib?  And he said, Yes.  And then he
24   said, Okay.  Any other reason?  And he said, There
25   would be -- there maybe probably follow-up would be an
0013
 1   issue, so...
 2             But, you know, he was getting things that
 3   were -- as part of the procedure that were still being
 4   written about in terms of safety, feasibility, things
 5   like that.  So really that was a study.
 6        Q    Okay.  We'll get to that in a minute.
 7        A    Sure.
 8        Q    Looks like then you also put a line next to
 9   Page 183 of Dr. Burkhardt's deposition, Line 8 through
10   16, and why did you write a letter next to that or a
11   mark next to that?
12        A    Retrospective data on...  Right.  So I think
13   one of the problems I had was that in terms of looking
14   at data and factors that, from the articles that were
15   published at least where they talked about stroke, his
16   particular data set -- data point on strokes related
17   to this I don't think were in any of the articles, and
18   so I couldn't -- unless I missed it -- I couldn't find
19   him in terms of the kind of stroke he had, and the
20   characterization of his outcome and his other things.
21   So in terms of studying it or looking at factors that
22   might have explained his situation, if he wasn't
23   included in the data set then it would be very
24   difficult to analysis.
25        Q    So what you're saying is looking at the
0014
 1   articles that you have from the Cleveland Clinic you
 2   did not see anywhere where Mr. Sullivan, in
 3   particular, was written about?
 4        A    Right.  So they have a list of all of the
 5   people that had strokes during their various ways of
 6   doing things as it evolved over time, so you looked
 7   for somebody that had, you know, the CHADS2 and scored
 8   zero, and the type of stroke, and when it occurred
 9   relative to the procedure, and, you know, how did they
10   do, what was the initial stroke scale, what was the
11   follow-up bar cell.  I didn't find anything that
12   matched.  So unless I -- either the numbers are off or
13   he wasn't included for whatever reason, I didn't find
14            Steven Richard Levine, M.D.  -  March 29, 2011
15        Q    Okay.
16             Now when you authored your report in this
17   case of August 6, 2010, you, as you reflected here on
18   No. 3, had read Dr. Burkhardt's deposition, correct?
19        A    Yeah.  I mean, I reviewed it, right.
20        Q    And then you have here, No. 4, you list how
21   you've seen the Cleveland Clinic policies and
22   procedure regarding informed consent?
23        A    Right.
24        Q    You have some archived web pages -- I think
25   that's in here somewhere -- from what was on the
0015
 1   website back in 2006, correct?
 2        A    Yes.
 3        Q    Then as we talked about six through nine are
 4   subsequent treating records from Hawaii?
 5        A    Um-hum.
 6        Q    Correct?
 7        A    Yes, yes.
 8        Q    And then No. 10 you have something
 9   documented as attorney work-product?
10        A    Right.
11        Q    Did you bring that with you here today?
12        A    No.
13        Q    What was the attorney work-product?
14        A    It was, I think, some summary of some of the
15   facts in the case.
16        Q    And you received that --
17                  MS. CARULAS:  You can have a
18        continuing objection if you want.
19                  MR. KULWICKI:  Yeah.
20                  I object, and you can ask
21        some more questions, but I may at some
22        point in time instruct him not to
23        answer.  But go ahead, please.
24        Q    When did you receive this attorney
25   work-product document?
0016
 1        A    I don't have a recollection of the specific
 2   day.   I -- obviously, before -- whatever date is on
 3   that report when I've had a chance to read it and --
 4   with all my other materials.
 5        Q    So it was sent to you with all of the other
 6   materials in this case, correct?
 7        A    I don't know if it was all one separate
 8   mailing or two or three mailings, I don't have a
 9   recollection of how many individual mailings there
10   were for that whole list of things.  I think maybe the
11   films came separate, you know.
12        Q    Sure.
13        A    I mean, I just don't recall how many
14   mailings there were.
15        Q    But it was sent to you and you reviewed it
16   prior to arriving at your opinions in this case?
17        A    Well, I mean it was part of what I had
18   reviewed.  I don't think it influenced my opinions
19   because it was a summary of what I was able to
20   determine on my own from the records because I went
21   through the records myself as well, so...
22        Q    As you sit here today, whether or not you
23   recall a fact from a medical record per se or from the
24   summary, are you able to distinguish between the two?
25                  MR. KULWICKI:  Objection.
0017
 1        A    I don't know.  I mean, my policy has always
 2   been to go to source documentation and try to look at
 3   what do I know because sometimes there could be errors
 4   in summarization, there could be, you know, different
 5   opinions or approaches.
 6             So I -- you know, I read it.  If I'm sent
 7   it, I read it.  But in terms of my opinions I --
 8   everything that I wrote in there I believe was taken
 9   from the medical records in terms of any facts or
10   issues that I was aware of.
11             Do you know how many pages this attorney
12   work-product document was?
13        A    No, not off the top of my head, a couple.
14        Q    Did it include, you say, a summary of facts?
15        A    Right.
16        Q    Did it also include a summary of medical
17   literature?
18        A    Literature?   I don't recall.
19        Q    Did it include a summary of plaintiff's
20   theory in this case?
21                  MR. KULWICKI:  Well, I'm
22        going to object, and I'm going to
23        instruct the witness not to answer
24        because to the extent that attorney
25        work-product is used by my office to
0018
 1        communicate with an expert for purposes
 2        of learning information from the expert
 3        and asking questions that we have
 4        raised in our minds as part of our
 5        investigation into a matter, I think
 6        it's protected.  I think it deserves to
 7        be highly confidential, and I'll
 8        instruct the witness not answer that
 9        question.
10                  I'll allow you to ask inquiry
11        about the witness' recollection of the
12        form of it so that it can be identified
13        for later discussion, but I think
14        you've pretty much covered that and
15        exhausted that so I think you should
16        move on.
17                  But if you feel like you want
18        to try to get further identification of
19        this work-product for purposes of
20        raising it before the judge, that's
21        fine.
22                  I'm going to instruct him,
23        however, to not any questions that go
24        to the substance of it.
25                  MS. CARULAS:  Okay.
0019
 1                  I think the only way for the
 2        judge to make a determination is if I
 3        get an indication from this witness as
 4        to what the nature of it is, then the
 5        issue becomes whether I get a copy of
 6        it or not.
 7                  So, I mean, to me it's at
 8        your peril if you do not allow him to
 9        answer the questions as to whether or
10        not it included theories of the
11        plaintiff's case in this.
12                  MR. KULWICKI:  Yeah,
13        that's --
14                  MS. CARULAS:  But that's your
15        choice.
16                  MR. KULWICKI:  That's fine,
17        yeah.
18                  MS. CARULAS:  Okay.
19        Q    I think I asked you, but I forget.
20             Do you remember how many pages it was?
21        A    A couple maybe, several.  I mean, it was
22   more than one and probably less than ten.
23        Q    Okay.
24             Now, sir, have you read any other
25   depositions other than the deposition of Dr.
0020
 1   Burkhardt?
 2        A    I don't recall if I was sent any other
 3   depositions, I don't think so.
 4        Q    Okay.
 5        A    I didn't find them.  When I looked at my
 6   file I don't think I saw any others.
 7        Q    All right.
 8             Now you have been provided with two reports
 9   in this case?
10        A    Correct.
11        Q    One report is by Dr. Chabon, C-H-A-B-O-N,
12   and the other by Dr. Moreno, M-O-R-E-N-O.   When were
13   you provided with those two reports?
14        A    Probably a week or two ago.
15        Q    And have these two reports influenced your
16   opinions in any way?
17        A    I think they solidify in a more detailed,
18   crystalized fashion for me some of the issues that I
19   was grappling with and concerned about in the case.  I
20   think that they express it in a more detailed way,
21   especially from an electrophysiologic point of view
22   where I'm, obviously, not a cardiologist, but in terms
23   of other some of the other issues related to some of
24   the ethic of informed consent and some of the issues
25   raised by Dr. Moreno, you know, I think it sets out,
0021
 1   you know, in a more crystalized, clear way some of the
 2   concerns and issue that I had thought about or
 3   grappled with.
 4        Q    So when you say, they solidified them,
 5   before you reviewed these two documents what you're
 6   saying is you were grappling with some opinions on the
 7   issues?
 8        A    Right.  I was sort of weighing them out and
 9   thinking about them and -- right.
10        Q    Okay.
11             And you're saying after you've reviewed
12   these documents --
13        A    I think they crystalized it.  I think they
14   were able to put into the words things that I had
15   thought about and was concerned about, but they put in
16   a very eloquent way, and I tend to agree with them.
17        Q    Okay.
18             The opinions that are set forth in the
19   reports that you just reviewed in the last two week of
20   Dr. Moreno and Dr. Chabon that you say are eloquent
21   opinions that help solidify some issues you were
22   grappling with before, those issues or concerned were
23   not raised in your report of August 6, 2010?
24        A    Right.
25                  MR. KULWICKI:  Objection.
0022
 1        Q    All right.
 2                  MR. KULWICKI:  Objection.
 3        A    I think in part because of what I was asked
 4   to specifically do for the purpose of the report.
 5        Q    Tell me what it is you were asked to do in
 6   this case?
 7        A    What I was asked to do was to look at the
 8   stroke as it relates to causation and issues related
 9   to treatment, issues related to risk that was put on
10   Mr. Sullivan from how things were done.   That was
11   pretty much the essence of what I was asked to look at
12   and do.
13        Q    All right.
14             So we've talked about the one issue you were
15   asked, whether or not the subsequent care after the
16   stroke was appropriate?
17        A    Right.
18        Q    And the involvement of all of those folks.
19   We know there was a Dr. Abou-Chebel involved?
20        A    Right.
21        Q    Do you know Dr. Abou-Chebel?
22        A    I don't know him personally.
23        Q    But you know of him by reputation?
24        A    By name, yeah.
25        Q    And so as you looked at that whole aspect
0023
 1   you felt everything was reasonable there?
 2        A    Right.
 3        Q    Okay.
 4             So then you were also asked to look at the
 5   issue of causation.  Explain to me what you mean by
 6   that.
 7        A    What I mean is why did he have a stroke?
 8        Q    Okay.
 9        A    What were the factors that contributed to
10   his stroke?
11        Q    Okay.
12             And then you say issue about treatment.
13        A    Well, the whole issue about -- again, I'm
14   not a cardiologist, I acknowledge that that's going to
15   come up.  I do electron, and I deal with stroke
16   prevention and A-Fib and risk benefits of various
17   treatments all the time, it's part of being on the
18   receiving end of the stroke, right.
19             But also in terms of primary prevention of
20   stroke, secondary prevention of stroke.   And so for
21   any individual you have to sort of look at, you know,
22   how are they being managed for their A-Fib?  Were
23   there other risk factors?  How aggressive does someone
24   want to be or should be with managing the A-Fib other
25   than with medication, but through various procedures
0024
 1   that have come along and other things?
 2        Q    Right.
 3        A    And whether that was appropriate or not, and
 4   whether the risk benefits are in a position where
 5   patients are in a position to adequately assess those
 6   risks and benefits, given all the information they
 7   need to make an informed decision as it relates to
 8   management and treatment.  And whether certain things
 9   are expected and other things are -- you know, either
10   more aggressive treatment or, you know, research or
11   however you want to label it, you know, cutting edge,
12   I mean there's various terminologies that can be used.
13   And so basically sort of looking at that sort of -- of
14   a view in terms of, you know -- you know.
15             Sort of like, you know, if your mom or I
16   had, you know, a low CHADS2 score, and what were the
17   reasons for looking to do more aggressive management
18   for it, and what were the risks and benefits, you
19   know.  How well was that really analyzed and discussed
20   and, you know, brought to bear in terms of the way he
21   was ultimately managed.
22        Q    All right.
23        A    So those sort of things.
24        Q    Now, we have a stack of literature here --
25        A    Right.
0025
 1        Q    -- that I have marked, and I'm going to go
 2   through it for the record, as Dr. Levine Exhibits A
 3   through O.
 4        A    All right.
 5        Q    Were all of these pieces of literature
 6   provided to you by Mr. Kulwicki (handing)?
 7        A    (Witness perusing document.)
 8             Some duplication here.  It's a lot of
 9   duplications here.   I don't know.   Most of them
10   were.  I think I may have printed out the 2006
11   American Heart Association Guidelines.  I can't
12   recall, but I think I may have.
13        Q    Okay.
14        A    But I think everything else was provided by
15   attorney.
16        Q    Okay.
17                  MS. CARULAS:  And just for
18        the record housekeeping purposes we'll
19        go through them.
20        A    I think there's a bunch of duplicates there.
21        Q    Are there?  Okay, I did it quickly.
22        A    Sure.
23                  MS. CARULAS:  So the first
24        article which I've marked as A Levine
25        is the Kanj, K-A-N-J, Article from
0026
 1        2007, Pulmonary Vein Antrum Isolation.
 2                  (WHEREUPON, the
 3        above-referred to document, the Kanj
 4        article from 2007, Pulmonary Vein
 5        Antrum Isolation, was marked Levine
 6        Exhibit A for identification, as of
 7        this date.)
 8        Q    There's some area that, obviously, had been
 9   highlighted before copied.  That came to you that way
10   by Mr. Kulwicki, I assume?
11        A    Yes.
12        Q    And then there are blue writings with
13   different things outlined and written, that's your
14   writing?
15        A    Correct.
16        Q    Okay.
17                  MS. CARULAS:  And B is an
18        Article by Di Biase, D-i capital
19        B-I-A-S-E, entitled Remote Magnetic
20        Navigation, 2007.
21                  (WHEREUPON, the
22        above-referred to document, an Article
23        by Di Biase entitled Remote Magnetic
24        Navigation, 2007, was marked Levine
25        Exhibit B for identification, as of
0027
 1        this date.)
 2        Q    And the same is true with the blue, it's
 3   yours?
 4        A    Yes.
 5                  MS. CARULAS:  C is the 2007
 6        article where Wazni, W-A-Z-N-I, is the
 7        lead of the article, Atrial
 8        Fibrillation Ablation In Patients With
 9        Therapeutic INR.
10                  (WHEREUPON, the
11        above-referred to document, the 2007
12        article where Wazni is the lead of the
13        article, Atrial Fibrillation Ablation
14        In Patients With Therapeutic INR, was
15        marked Levine Exhibit C for
16        identification, as of this date.)
17        A    Correct.
18        Q    And here we have your underlining is both in
19   black and blue; right, is this your black pen
20   (handing)?
21        A    (Witness perusing document.)
22             Looks like it.  Yeah, correct.
23        Q    All right.
24        A    I think so.
25        Q    All right.
0028
 1                  MS. CARULAS:  Exhibit D is
 2        the Heart Rhythm Society, et cetera,
 3        Expert Consensus Statement on Catheter
 4        and Surgical Ablation where Dr.
 5        Calkins, C-A-L-K-I-N-S, is the lead
 6        author.
 7                  (WHEREUPON, the
 8        above-referred to document, the Heart
 9        Rhythm Society, et cetera, Expert
10        Consensus Statement on Catheter and
11        Surgical Ablation where Dr. Calkins is
12        the lead author, was marked Levine
13        Exhibit D for identification, as of
14        this date.)
15        Q    And the same is true with your blue and
16   black pen?
17        A    Correct.
18        Q    And do you know Dr. Calkins?
19        A    No.
20        Q    And prior to looking at this, had you ever
21   heard of Dr. Calkins?
22        A    No.
23                  MS. CARULAS:  Exhibit E is a
24        second copy.
25                  (WHEREUPON, the
0029
 1        above-referred to document, a second
 2        copy, a repeat of a prior exhibit, was
 3        marked Levine Exhibit E for
 4        identification, as of this date.)
 5        A    Um-hum.
 6                  MS. CARULAS:  Which I
 7        shouldn't have marked, but I've already
 8        done it.  So that's a repeat of a prior
 9        article, and there is no documentation
10        on that.
11                  Exhibit F is an article where
12        the lead author is Di Biase, as the
13        lead author of a two thousand, I
14        believe, ten article in circulation
15        entitled Periprocedural Stroke.
16                  (WHEREUPON, the
17        above-referred to document, an article
18        where Di Biase is the lead author of a
19        2010 article in circulation entitled
20        Periprocedural Stroke, was marked
21        Levine Exhibit F for identification, as
22        of this date.)
23        Q    Correct?
24        A    Um-hum, yes.
25        Q    And I wonder if you were sent this before or
0030
 1   after you authored your report; do you know?
 2        A    I can't recall.
 3        Q    The lead author is Dr. Di Biase, had you
 4   ever heard of him before --
 5        A    No.
 6        Q    -- looking at this article?
 7             Okay.
 8             Prior to looking at this article, had you
 9   recognized any of the authors?
10        A    Well, Burkhardt is the treating physician,
11   he's the second author.  And then -- no, I don't know
12   any of the other authors.
13        Q    And I take it prior to reviewing this case,
14   you had never heard of Dr. Burkhardt, correct?
15        A    Correct.
16        Q    And prior to reviewing this case, you had
17   never heard of Dr. Natale, N-A-T-A-L-E?
18        A    You know, I might have seen that name
19   because I think that's one of the more senior people
20   at the Cleveland Clinic in cardiology and he may have
21   been authored on various guidelines and other things.
22   I mean, the name, but I don't know the person
23   personally.
24        Q    You would have just known him by hearing
25   his --
0031
 1        A    By name, by name, by name.
 2        Q    Okay.
 3                  MS. CARULAS:  And then
 4        Exhibit G is an article entitled Atrial
 5        Fibrillation Ablation Without
 6        Interruption of Anticoagulation.  The
 7        lead author is S-A-N-T-A-N-G-E-L-I.
 8                  (WHEREUPON, the
 9        above-referred to document, an article
10        entitled Atrial Fibrillation Ablation
11        Without Interruption of
12        Anticoagulation; the lead author is
13        Santangeli, was marked Levine Exhibit G
14        for identification, as of this
15        date.)
16        Q    Correct?
17        A    Yeah.  I wasn't paying attention to the
18   spelling, but yeah.
19        Q    Okay.
20             And you have some of your writing here.
21   Again in the blue you have some double exclamation
22   points next to Dr. Natale.  What is the --
23        A    I was pretty impressed that he's got five
24   different city -- appointments in five different
25   cities in terms of different job characteristics and
0032
 1   things and just being extremely crazy busy to have
 2   appointments in five different cities around the
 3   country.
 4        Q    Okay.
 5        A    That's all.  I just thought it was whoa.
 6                  MS. CARULAS:  Exhibit H is
 7        maybe a repeat of --
 8        A    Yes.
 9                  MS. CARULAS:  -- of Di Biase.
10        A    Yes.
11                  MR. KULWICKI:  Which one?
12                  MS. CARULAS:  Circulation.
13                  (WHEREUPON, the
14        above-referred to document, a repeat of
15        Dr. Di Biase circulation, was marked
16        Levine Exhibit H for identification, as
17        of this date.)
18                  MS. CARULAS:  Exhibit I, we
19        have another copy of the
20        S-A-N-T-A-N-G-E-L-I article.
21                  (WHEREUPON, the
22        above-referred to document, another
23        copy of the Santangeli article, was
24        marked Levine Exhibit I for
25        identification, as of this date.)
0033
 1        A    Correct.
 2        Q    Do you know why you have multiple copies in
 3   your file?
 4        A    Because I may have asked my secretary to
 5   print them out, and she was having computer problems
 6   and so I ended up printing them out myself, and then
 7   she got her computer fixed.
 8        Q    Okay.
 9        A    So she printed them all out again.
10        Q    All right.
11             So these would be sent to you by e-mail from
12   Mr. Kulwicki?
13        A    Yes.
14                  MS. CARULAS:  Then we have a
15        third copy, which I should have looked
16        at them all beforehand.  The third copy
17        is J of the Di Biase article in
18        circulation.
19                  (WHEREUPON, the
20        above-referred to document, a third
21        copy of the Di Biase article in
22        circulation, was marked Levine Exhibit
23        J for identification, as of this
24        date.)
25        A    Okay.
0034
 1                  MS. CARULAS:  And then we
 2        have Exhibit K which is another copy of
 3        Dr. Wazni's article.
 4                  (WHEREUPON, the
 5        above-referred to document, another
 6        copy of Dr. Wazni's article, was marked
 7        Levine Exhibit K for identification, as
 8        of this date.)
 9        A    Okay.
10                  MS. CARULAS:  Then there's
11        is an article where Dr. Patel,
12        P-A-T-E-L, is the lead author,
13        Long-Term Functional and Neurocognitive
14        Recovery is the article.
15                  (WHEREUPON, the
16        above-referred to document, an article
17        where Dr. Patel is the lead author,
18        Long-Term Functional and Neurocognitive
19        Recovery, was marked Levine Exhibit L
20        for identification, as of this
21        date.)
22        Q    Again with some of your writing on it?
23        A    Yes.
24                  MR. KULWICKI:  That's L?
25                  MS. CARULAS:  That's L, yes.
0035
 1        Thank you.
 2                  M are the ACC/AHA/ESC 2006
 3        guidelines which we've marked as M.
 4                  (WHEREUPON, the
 5        above-referred to document, the
 6        ACC/AHA/ESC 2006 Guidelines, was marked
 7        Levine Exhibit M for identification, as
 8        of this date.)
 9        Q    Correct?
10        A    Correct.
11                  MS. CARULAS:  And then N
12        appears to be the same thing, but
13        thicker, okay.
14                  (WHEREUPON, the
15        above-referred to document, the same
16        thing as Exhibit M but thicker, was
17        marked Levine Exhibit N for
18        identification, as of this date.)
19                  MS. CARULAS:  And then we
20        have another copy, it looks like, as
21        Exhibit O of the Heart Rhythm Society
22        2007 Expert Consensus.
23                  (WHEREUPON, the
24        above-referred to document, another
25        copy of the Heart Rhythm Society 2007
0036
 1        Expert Consensus, was marked Levine
 2        Exhibit O for identification, as of
 3        this date.)
 4        Q    Besides this stack which contains many of
 5   the same, have you reviewed any other medical
 6   literature in this case?
 7        A    Not specific to this case.  I've reviewed a
 8   lot of medical literature as it relates to stroke and
 9   A-Fib in general.  It's just part of my job, my
10   lectures, various things, but not specifically for
11   this case.
12        Q    So as far as what is helping to assist you
13   to formulate your opinions, we've been through that
14   and they've been marked as an exhibits?
15        A    Plus.  I mean, I can't take away all the
16   other stuff that I've read that wasn't necessarily for
17   this case that bears on stroke, stroke risk, atrial
18   fibrillation, management, you know, things that I just
19   know and practice and read about or go to meetings and
20   hear on a regular basis.  I mean, it's hard to tease
21   that out.
22        Q    Sure.
23             As far as any other literature that would be
24   considered from the electrophysiology world --
25        A    Correct, correct.
0037
 1        Q    Any other literature you read on a regular
 2   basis would be in the stroke, neurology field?
 3        A    Right.  I do follow some of the
 4   electrophysiology literature just out of interest
 5   because, I mean, personally my dad has A-Fib and, you
 6   know, he's been talking to his cardiologist about
 7   various approaches, and I read up, and I talk to my
 8   father about stuff.
 9             Even though I'm not a cardiologist, you
10   know, he just asks me.  And my good friend, he's a
11   cardiologist down in Florida so we chat.  So that's
12   sort of...
13        Q    Okay.
14        A    But, yeah.  No, I don't go looking through
15   the electrophysiology journals for reading material
16   unless something is a pertinent article or is a big,
17   breakthrough kind of article I might look at it, you
18   know, something like that.
19        Q    All right.
20             In your practice, what are the journals you
21   regularly read?
22        A    Well, I mean, nowadays, yeah, I don't
23   really, really read journals cover to cover.  I skim
24   them or get notification of pertinent articles through
25   literature searches and things.
0038
 1             So, I mean, I typically look at anything
 2   stroke related, the New England Journal, JAMA, LaMSID,
 3   Stroke, Neurology, Annals of Neurology, Circulation,
 4   Archives of Neurology, Journals of Stroke and Cerebral
 5   Circulation, Annals of Internal Medicine.
 6        Q    Okay.
 7        A    But I don't go through every article in
 8   every one of these journals every week, so I mean, you
 9   know --
10        Q    Sure, right.  If it's something --
11        A    I wouldn't have any time to do anything
12   else.
13        Q    Right.  If it's something that is within
14   your field?
15        A    Right.
16        Q    All right.
17        A    Or of interest.  Even if it's not
18   specifically in my field, but it's of interest I
19   would...
20        Q    You did not mention, I take it, as part of
21   your regular reading you do not review the Journal of
22   Cardiovascular Electrophysiology?
23        A    Correct.
24        Q    And you do no regularly read the Journal of
25   the American College of Cardiologist?
0039
 1        A    Right.  No, I read articles from there, but
 2   I don't regularly review it.
 3        Q    The journal Current Cardiologist Rep, do you
 4   read that on a regular basis?
 5        A    No.
 6        Q    Prior to or at any point in time -- I know
 7   you mentioned a little bit ago you had not heard of
 8   Hugh Calkins.  Have you ever read his book entitled A
 9   Practical Guide To Catheter Ablation in Atrial
10   Fibrillation?
11        A    No.
12        Q    To I take it you would not have read any of
13   the chapters in that written by Dr. Burkhardt, for
14   instance?
15        A    Correct.
16        Q    And I assume the Journal of the Heart and
17   Rhythm Society is not something you regularly read?
18        A    Correct.
19        Q    And you smiled?
20        A    I'm not a cardiologist.
21        Q    Okay.
22             And you are not a member of the Heart and
23   Rhythm Society, correct?
24        A    No.  I just hope mine stays in rhythm.
25   That's all.
0040
 1        Q    Okay.
 2             And you're not a member of the American
 3   College of Cardiologist?
 4        A    Correct.
 5        Q    Now, as far as the other experts that are in
 6   this case, within the last two weeks we know you were
 7   sent a report of Dr. Moreno, he's an ethicist, and Dr.
 8   Chabon.  Do you know any anything about the
 9   credentials of Dr. Chabon?
10        A    No.
11        Q    Do you know what his M.D. degree is in?
12        A    M.D. degree?  I assume medicine.
13        Q    Yes.
14             Do you know what his training is after
15   receiving --
16        A    Oh, his residency?  No, I don't.
17        Q    Do you know what his area of speciality is?
18        A    The way he talks I would assume cardiology.
19        Q    Okay.
20        A    But I can't -- I mean, I'm not -- I don't
21   know for sure, but I assume cardiology.
22        Q    Would it surprise you if he was a
23   pediatrician?
24        A    Would it surprise me?  Without additional
25   cardiac training?
0041
 1        Q    Yes.
 2        A    Yeah, I might be a little surprised.
 3        Q    Okay.
 4             Did Mr. Kulwicki tell you that he is a
 5   retired pediatrician?
 6        A    No.
 7                  MR. KULWICKI:  Well, Anna,
 8        just in fairness, I mean, he also has a
 9        Master's in hospital administration and
10        that's how we presented him, as an
11        expert in hospital administration and
12        policies and procedures.
13                  So I don't think it's fair to
14        sort of cast him as a pediatrician
15        because that's not how we're presenting
16        him in this case.
17        A    Oh, I misspoke about who I though -- I was
18   talking about the person who I thought was talking
19   about all the different cardiac procedures or
20   something maybe somewhere else.  So I misspoke about
21   this because it -- I mean, based on this it doesn't
22   necessarily mean that he has to be a cardiologist from
23   this report.  I was thinking of something else.
24        Q    What are you thinking about where you read
25   something from a cardiologist?
0042
 1        A    Maybe it was something else.  I don't know.
 2   Maybe it was just -- maybe I saw it based on the last
 3   line about the keyhole maze procedures.  Potentially I
 4   would have thought that would have been somebody with
 5   a cardiology background.
 6        Q    Okay.
 7             I'm just going to just for the -- and then
 8   you'll have this too afterwards to refer to
 9   (indicating).
10                  MS. CARULAS:  So we're going
11        to mark Chabon's Report as P and
12        Moreno's Report as Q.
13                  (WHEREUPON, the
14        above-referred to documents, Dr.
15        Chabon's Report and Dr. Moreno's Report
16        were marked Levine Exhibits P and Q,
17        respectively, for identification, as of
18        this date.)
19        Q    Did you have any understanding as to Dr.
20   Chabon's -- what he currently is involved in?
21        A    I'm not sure what you mean by that.
22        Q    Do you know what his current professional
23   activity is?
24        A    No, I don't.
25        Q    Were you advised that the only thing Dr.
0043
 1   Chabon is currently doing is working for a plaintiff's
 2   medical practice law firm as an attorney?
 3        A    No, I didn't know that.
 4        Q    Would that influence your opinions at all?
 5        A    Not necessarily, I took it at face value
 6   what was being said.
 7        Q    You would agree that in order to have
 8   meaning when someone says something you need to have
 9   some background qualifications?
10        A    Depends.
11        Q    Okay.
12        A    Depends what they're saying.
13        Q    Okay.
14             Do you know what the background of Moreno
15   is?
16        A    Yeah, I think so.  I think he's got a --
17   he's an endowed chair professor at -- I think he runs
18   the Ethics Department at Penn.
19        Q    Do you have any understanding as to whether
20   he has a medical degree?
21        A    He's got a PhD it says there.
22        Q    Okay.
23             Now, have you been provided with any reports
24   of any cardiologists in this case?
25        A    I don't recall.
0044
 1        Q    Have you asked Mr. Kulwicki whether or not
 2   any cardiologists have given opinions in this case?
 3        A    I think we talked a little bit about
 4   potential experts and, you know, I don't -- I don't
 5   think I got the actual depositions of any of them if
 6   they were deposed.
 7        Q    And what was your understanding as to who
 8   the folks were that are involved from a cardiology
 9   standpoint?
10        A    A cardiologist from the University of
11   California, San Francisco.
12        Q    And have you seen his report?
13        A    No.
14        Q    And do you know who he is?
15        A    I've heard the name before, but no, I don't
16   know who he is.
17        Q    The only way you know about what he says is
18   through Mr. Kulwicki?
19        A    Correct.
20        Q    Do you know what his qualifications are
21   within the area of cardiology?
22        A    Not specifically, no.
23        Q    Do you know whether he's an
24   electrophysiologist?
25        A    No, I don't know.
0045
 1        Q    Besides the doctor from UCSF, are you aware
 2   if there are any other cardiologists or
 3   electrophysiologist involved in this case?
 4        A    As experts?
 5        Q    Yes.
 6        A    Not that I'm aware of.  No, I'm not aware.
 7        Q    Okay.
 8             Have you asked Mr. Kulwicki whether or not
 9   there are any other electrophysiologists that have
10   given an opinion in this case?
11        A    I don't think I specifically asked him that.
12        Q    And you haven't been told, am I correct?
13        A    Right.   I mean, unless this person from
14   UCSF is an electrophysiologist.
15        Q    All right.
16             Tell me currently what your practice
17   entails?
18        A    My practice?
19        Q    Yes.
20        A    I see in-patients.  I see out-patients.  I
21   do consultations.  I do research.  I have some
22   teaching responsibilities and some administrative
23   responsibilities.
24        Q    And what is the area of your practice?
25        A    I'm a neurologist, and I'm a stroke
0046
 1   neurologist.  So I do some general neurology, as well
 2   as stroke neurology.
 3        Q    And what amount of time do you spend
 4   actually doing clinical neurology?
 5        A    Between teaching and seeing patients or just
 6   part of the thing is I attend on the service, and I
 7   see patients as the attending of record.  And then I'm
 8   also teaching at the same time and doing that.  And I
 9   do that, you know, teaching and seeing patients both
10   in the out-patient and the in-patient setting, you
11   know, 40, 50 percent of the time.   Maybe a little
12   less, maybe a little more depending on the month or
13   the -- what's going on, how busy things are.  And
14   then, you know, 40, 30 percent, 35 maybe some months
15   40 percent research.   And then the rest some
16   administration and some more didactic teaching as
17   opposed to bedside teaching.
18        Q    What is the split between doing stroke
19   neurology versus general neurology?
20        A    Well, as an in-patient it's the stroke
21   service, but sometimes we -- when we run stroke code
22   we see that there was really a seizure or some
23   metabolic problem or it wasn't really a stroke and we
24   end up taking care of that patient for awhile unless
25   we transfer them to the general neurology service.
0047
 1   So -- but most of it is stroke.   Some of it's
 2   seizures or other complications.
 3             And then in the out-patient setting most of
 4   it is stroke and -- but, you know, depending on seeing
 5   people who need to be seen or favors for friends or
 6   whatever, people referrals, you know, I see general
 7   neurology too, tumors, carpel tunnel, neuropathy,
 8   whatever.
 9             If you want a percentage of my out-patient
10   practice that is non-stroke, I would say 15, 20
11   percent, maybe something in that ballpark.
12        Q    Okay.
13             Now, I know you did your training in
14   Michigan and then were at initially Henry Ford and
15   then Wayne State?
16        A    Correct.
17        Q    Why did you leave Wayne State?
18        A    Oh, I left Wayne State because we needed
19   religious day schools for the kids.  They were all
20   that age where we were not getting what we needed in
21   the Detroit Community, so we needed to go to a place
22   with a larger choice of various schools for the three
23   kids who needed different sort of paths in their
24   lives, and that's why we moved.
25        Q    Okay.
0048
 1        A    So that had nothing to do with my
 2   profession.
 3        Q    It was a personal decision?
 4        A    It was purely a personal decision with my
 5   wife about the kids.
 6        Q    All right.
 7             And you came initially to Mount Sinai?
 8        A    Correct.
 9        Q    And were at Mount Sinai until just last
10   summer?
11        A    Right, for nine years or something.
12        Q    And then have moved now to SUNY --
13        A    Right.
14        Q    -- Downstate?
15        A    Correct.
16        Q    What led to that change?
17        A    Well, the chairman at SUNY Downstate I've
18   known for twenty-five years, he's a friend and
19   colleague, and ever since he got there five years ago
20   he's been trying to twist my arm to come.
21        Q    That's Dr. Rosenbaum?
22        A    Yeah.
23        Q    Okay.
24        A    You know him.
25        Q    Well, I'm here to ask your deposition.
0049
 1        A    But anyway...
 2        Q    Okay.
 3        A    So things at -- for me at Sinai -- you know,
 4   initially there was a lot more research activity, and
 5   I think it's over time some of the -- my colleague and
 6   people in the stroke area were more steering towards
 7   clinical work and less research.  And so I, you know,
 8   felt that it was my opportunity to become a vice chair
 9   and to have a role in the Dean's Office and to do
10   various other things that are a little but more of a
11   departmental level.  And I felt it was nice
12   opportunity and Dan is a -- Dr. Rosenbaum is a
13   wonderful person and a chance to work with him, it
14   just seems like it was a little bit of a push and a
15   pull on both ends and so it worked out.
16        Q    Okay.
17             And, at least according to the website, it
18   looks like the Director of Stroke and cerebral
19   vascular disease is Dr. Baird, B-A-I-R-D?
20        A    Allison Baird, yes.  She's the Director of
21   the Stroke Center.  I've done that for enough years
22   back in Michigan, I didn't need to do that again.
23        Q    You need to tell them to put you on the
24   website.  You're not on any of the websites.
25        A    Oh, is that right?  They're a little slow.
0050
 1   The state university with major budget cuts coming.
 2        Q    Now tell me this, what's the difference
 3   between SUNY Downstate and SUNY upstate?
 4        A    Okay.  So the State University of New York
 5   is like the University of California system or the
 6   University of Texas system.  It's a state based public
 7   education enterprise that has undergraduate campuses,
 8   graduate school campuses and medical center campuses.
 9   And so there are four medical center campuses in New
10   York State, upstate, Stony Brook, Buffalo and
11   Downstate.  So there are four SUNYs that have medical
12   schools, they're public medical schools as opposed to
13   private institutions like Sinai, Columbia, Cornell,
14   NYU, things like that.
15        Q    Okay.
16        A    And so we're a state university faculty,
17   SUNY faculty, as opposed to U California or UCSF, UCSD
18   in L.A., we're sort of a New York equivalent of that.
19        Q    But the largest institution at upstate?
20        A    You know, it's a good question.  It's
21   depends how you want to define largest.  Is it the
22   largest by campus or students or acreage or is it
23   largest by NIH funding?  It's different measures.
24        Q    Okay.
25        A    So I think the overall -- if you include
0051
 1   like Roswell Park Cancer Institute, I think Buffalo is
 2   actually the largest campus.  It has the largest
 3   number of hospitals affiliated with it.  I think
 4   there's nine or eleven.  There are more graduate
 5   schools and other things.   And I think that SUNY
 6   Stony Brook -- the other thing is that we don't have
 7   an undergraduate, we're just a medical center, and we
 8   have nursing school, PTOT, some other allied health
 9   field.  But Stony Brook's got undergraduate and
10   they've got graduate and other degrees.  So -- and,
11   therefore, even Brookhaven National Laboratories, so
12   depending on how loose or tight your affiliations
13   with -- your size will be different.
14        Q    Okay.
15        A    So in terms of NIH funding I think -- not I
16   think, Stony Brook may have the most followed by --
17   I'm not sure, it's pretty close.  Buffalo upstate and
18   downstate are all pretty close.  It's all in like the
19   $50,000,000 range or something.
20        Q    All right.
21             So tell me, what's your involvement as an
22   expert witness.  How often do you review medical/legal
23   cases?
24        A    Well, I think it depends on the year and the
25   types of cases.   So there was a period of time --
0052
 1   well, I mean it started back when I was just starting
 2   out in stroke back in the mid-eighties a lawyer called
 3   me and -- so a lot of what I did was, you know,
 4   lawyers calling me, either a defense or plaintiffs, in
 5   various areas of interest that I've either published
 6   on or whatever.  And I don't know ten, twelve cases a
 7   year potentially where I would get called.  Maybe a
 8   little less than once a month or a little bit.  About
 9   once a month, depending.
10             And then there was this whole era of --
11   where I had written some papers on stroke related to
12   some pathomimetic as a class of drugs.  And then ten
13   years later there was this whole whoopla about
14   over-the-counter pathomimetics like PPA,
15   phenylpropanolamine,
16   P-H-E-N-Y-L-P-R-O-P-A-N-O-L-A-M-I-N-E.
17        Q    Okay, so --
18        A    And so I did work for that.  And then
19   because of that then ephedra became -- I did work on
20   ephedra, and then Vioxx, and I did work on Vioxx.  So
21   there was a whole bunch of stuff, it wasn't really
22   medical malpractice, but it was medical/legal, I guess
23   if you were rubric.
24             But, you know, I still now maybe eight, ten,
25   twelve cases a year, something like that, mixed,
0053
 1   pretty equal.  I mean, whoever calls I just say, you
 2   know, I call it as I see it as an empire.  I mean, it
 3   is what it is, as far my opinion.
 4        Q    Sure.
 5             Have you ever worked with Mr. Kulwicki
 6   before?
 7        A    I don't think so.  I mean, maybe eight years
 8   ago, twelve years ago, twenty years ago.  I -- I don't
 9   recall.  It's certainly possible.   I think the firm
10   changed in the last -- so I don't even remember what
11   the name of the previous firm.  I don't recall.
12        Q    Do you ever remember working a Mr. Becker,
13   Michael Becker of Mr. Kulwicki's former firm?
14        A    Could be -- yeah, I could have.  I don't
15   keep all those names available.
16        Q    Okay.
17        A    And  it's certainly possible.
18        Q    All right.
19             Do you keep a list as far as your --
20        A    So what I've been told in the past is that
21   when I do like federal cases I have to keep a list
22   current for like four or five years of just -- not all
23   my cases, but just the ones that I do deps or trials.
24   So I have a list for the last four or five years for
25   deps and trials.   But beyond that, you know, other
0054
 1   than for active billing -- once it's done with -- I
 2   don't -- I destroy all that stuff because it's...
 3        Q    So I'm going to ask that you provide that
 4   list that you do have to Mr. --
 5        A    Of my deps in trials for the last four or
 6   five years?
 7        Q    Sure, right.  Whatever you have.
 8        A    Sure.
 9        Q    And that would be the only list you
10   maintain?
11        A    Of deps and trials, yeah.
12        Q    Okay.
13        A    Other than that -- you know, I have a list
14   of, you know, cases that, you know, are active -- that
15   are still active with billing or something for the
16   last year or so.
17        Q    So would have that list as well?
18        A    Well, you know, it's not a list, it's just
19   files.
20        Q    Okay.
21             Do you have a billing record on this
22   particular case?
23        A    Yeah, I assume so.  Yeah.
24        Q    I'm going to ask that you provide that to
25   Mr. Kulwicki?
0055
 1        A    Okay.  If you could just make a list and
 2   e-mail me what you need and then I'll get it together.
 3        Q    And do you have a set fee schedule?
 4        A    Well, yeah.  I don't have it written down
 5   anywhere, but I have -- it is set.  I mean, I don't
 6   charge different people different amounts.
 7        Q    Do you have a written document that you send
 8   to attorneys when they --
 9        A    If they ask, but I don't have it prepared.
10   I mean, I just type it.  It's just very short.
11        Q    Did you do that in this case; do you know?
12        A    I don't recall.
13        Q    I'll put it on your list if you have it,
14   okay?
15        A    Well, I don't know that I would -- I mean,
16   if I had sent it to him then I wouldn't have it
17   because it would have sent either as an e-mail or --
18        Q    Well, why don't you just tell me then.
19             What do you charge per hour for review of
20   medical records?
21        A    So $500 an hour for review, and that
22   includes five hundred an hour for literature searches,
23   travel, conference calls, meeting, things like that.
24   If I -- like a written report is six hundred an hour.
25        Q    And what is your charge of deposition?
0056
 1        A    It's a thousand dollars an hour.
 2        Q    And what is your charge for testimony at
 3   trial?
 4        A    So I don't have a fixed fee for that.  It
 5   really depends on for where I'm going, if it's
 6   overnight, how long, half day, full day, local, not
 7   local, you know, plane, cab, whatever.  So it tends to
 8   be anywhere from -- I don't know, seven five hundred
 9   to fifteen thousand depending on, you know, if I'm
10   going cross country or overnight or whatever versus
11   local so...
12        Q    And are you, as you sit here today,
13   scheduled to come to Cleveland to testify in this
14   case?
15        A    I don't think I have anything on any
16   schedule for that.
17        Q    We're set to go to trial May 16th, not on
18   your schedule?
19        A    May 16th, no, I have anything on there.
20        Q    Okay.   Now --
21        A    I mean, nothing firm.  I mean, I may have
22   gotten an e-mail that may have notified me that that's
23   when it is, but I haven't been asked to set anything
24   specifically.  There's nothing in my datebook.
25        Q    Now you said you started reviewing
0057
 1   medical/legal cases what year?
 2        A    It would be '87, somewhere around there.
 3        Q    But it ranges anywhere from eight to twelve
 4   a year?
 5        A    Something like that.  With the product
 6   liabilities there was a bunch more of reviewing, you
 7   know, stuff like for phenylpropanolamine.  Then I
 8   got -- I think a couple of years ago there was this
 9   whole thing with one of the new preparation of birth
10   control pills, arthinova (spelled phonetically) or I
11   can't even remember the name, where they looked at a
12   bunch of -- it sort of came in bunches, young who has
13   had stroke with this new birth control preparation.
14   The ring, NuvaRing and things like that to look and
15   see if I thought there was relationship between
16   NuvaRing and the strokes.
17        Q    And with most of these product liability
18   case, were you retained on behalf of the plaintiff or
19   on behalf of the manufacturer?
20        A    I actually got called by both, but I had
21   accepted on the plaintiffs before I got -- so when the
22   defense people called I said, I really can't do both
23   sides.  Probably is not a good idea.
24        Q    And so can you estimate for me over the last
25   thirty years approximately, right, thirty --
0058
 1        A    Twenty-five?
 2        Q    Twenty-five years.
 3        A    Twenty-five, yeah.
 4        Q    How many cases you've been involved in as an
 5   expert, total cases?
 6        A    Oh gosh.  I mean, if we just take -- I mean
 7   it's rough, I can't give you an exact number.  But if
 8   we take an average of say ten cases a year for
 9   twenty-five years, I mean, it's two hundred and fifty
10   cases potentially.  Some were just looking at some
11   records and that's it, and others are -- as you'll see
12   on the list for the last four or five years, some go
13   to dep or trial, but very rare.  I mean, I've been --
14   I think I've been to trial like less than once a year,
15   maybe twenty times in twenty-five years.  It's pretty
16   unusual.
17        Q    Can you give me an idea as to the states
18   where you have been asked to get involved in
19   medical/legal matters?
20        A    Just to review records?
21        Q    Review or testimony, either.
22        A    Either?
23        Q    Sure.
24        A    Gosh, let me just go through my map.  I
25   don't think there's anything from Maine.  I've a case
0059
 1   or two from New Hampshire, some from Massachusetts.  I
 2   think one from Rhode Island.  I don't think any in
 3   Vermont.  A bunch in New York, Connecticut, New
 4   Jersey, Pennsylvania, Maryland, Washington, DC.
 5   That's not really a state.  Virginia, North Carolina,
 6   I don't know about South Carolina, Georgia, Florida,
 7   Michigan, Ohio, maybe one from St. Louis, Missouri.  I
 8   don't think anything from Arkansas, Louisiana.  I
 9   think one from Mississippi, but that might have been
10   one of the product liability ones.  I don't recall
11   anything from Alabama, maybe again a product liability
12   one.  Minnesota, I can't recall if there is anything
13   in Minnesota, nothing from North or South Dakota.
14   Wisconsin, don't recall anything from Wisconsin,
15   maybe.  I mean, I'm trying to go back twenty-five
16   years, so may have been.   Illinois, yes, Oklahoma, I
17   think theres a case in Oklahoma, Texas, Arizona.  I
18   don't think anything in New Mexico.  I don't recall,
19   maybe there was something in Nevada.  There was in
20   Washington.  Nothing in Idaho or Montana that I can
21   think of.   California, I think -- I don't recall
22   about Oregon.  Not Alaska, but I think there was one
23   case from Hawaii.  And I --
24        Q    I know, but your kids would be impressed,
25   okay.
0060
 1        A    I don't know.
 2        Q    Okay, sir.
 3             Have you, yourself ever been sued for
 4   malpractice?
 5                  MR. KULWICKI:  Objection.
 6                  You can answer.
 7                  THE WITNESS:  I can answer?
 8                  MR. KULWICKI:  Yes.
 9        A    Thank God no.
10        Q    Okay.
11             If you were and your peer, as a stroke
12   neurologist, was called into question, would you want
13   the individual evaluating your care and determining
14   whether it was reasonable or not to be a likewise
15   trained qualified stroke neurologist?
16                  MR. KULWICKI:  Objection.
17                  You can answer.
18        A    I think it depends on what the issues are in
19   the case.   If the issues in the case are specific to
20   stroke neurology, then yeah, I think that would be
21   good.  If they were more generic issues or other sorts
22   of medical issues, then it may not be important to
23   have specifically a stroke neurologist.   It think it
24   depends.  If you want me to give me scenarios...
25        Q    Okay.  Let me ask you:
0061
 1             Are you a member of the American Academy of
 2   Neurology?
 3        A    Yes.
 4        Q    Have you ever, in the various cases you've
 5   been involved in as an expert witness, ever been
 6   involved in a case that involved the care of an
 7   electrophysiologist before this?
 8        A    A neuro electrophysiologist, you mean like
 9   an EG or EMG or you're talking about --
10        Q    I'm talking about a cardiac
11   electrophysiologist?
12        A    Oh, cardiac?
13        Q    Right.
14        A    No, I don't think so.
15        Q    Okay.
16             Are primarily the cases, when you get
17   involved in them, issues that have to do with either
18   the care of a neurologist, such as yourself, or the
19   issue of causation, cause of the stroke?
20        A    Depends.  I mean, there's a whole bunch of
21   stuff that I get asked to look at depending on the
22   states that allow it for emergency care of stroke.
23        Q    Okay.
24        A    And where -- what the ER did.   And so
25   depending some states don't let me look at that or
0062
 1   whatever or you can't, but you can't testify or
 2   whatever, you know, and others do.  So depending on
 3   that, I have looked at emergency medicine care as
 4   well.
 5        Q    Okay.
 6        A    Of stroke, not of other diseases
 7   necessarily.
 8        Q    Right.
 9        A    And I try to limit -- I mean, throughout the
10   years I think there's maybe one exception early on.
11   But I only do stroke cases related to stroke.
12        Q    All right.
13             And, again, certain questions I have to ask.
14        A    Sure.
15        Q    But have you ever had a complaint or a
16   disciplinary action against you for violations of the
17   qualifications and guidelines for a physician expert
18   witness as documented by the American Academy of
19   Neurology?
20                  MR. KULWICKI:  Objection.
21                  You can answer.
22        A    I mean, not that I know of.  I mean, maybe
23   somebody has, but I don't have any -- I mean, I don't
24   know if I would get served with it or how that would
25   come to my attention, but I'm --
0063
 1        Q    Not to your knowledge at least?
 2        A    Not to my knowledge.
 3        Q    Okay.
 4        A    If I know something I don't, please, you
 5   know, share it.
 6        Q    Are you aware that there are guidelines
 7   promulgated by the American Academy of Neurology on
 8   the qualifications of guidelines for the physician
 9   expert witness?
10        A    Sure.
11        Q    And are those guidelines you attempt to
12   follow?
13        A    Sure.
14        Q    Okay.
15             And under the guidelines it says that:
16                  The physician expert witness should be
17        fully trained and a diplomate of the Specialty
18        Board to be qualified as an expert in a specific
19        field.
20             Does that make sense?
21        A    Should be board certified in their field?
22        Q    Right.  In their field of the subject matter
23   of the case.
24        A    Ahh.
25                  MR. KULWICKI:   Well, can you
0064
 1        show it to him?  I mean, I object to
 2        you paraphrasing.
 3        Q    Okay.  If you can see it right there, then
 4   can you follow along with me.  Under training and
 5   certification you see it says the American Academy of
 6   Neurology qualifications and guidelines for the
 7   physician expert witness?
 8        A    Okay.
 9        Q    And it says here under training and
10   certification:
11                  Physician expert witness should be
12        fully trained in a specialty and diplomate of a
13        Specialty Board recognized by the American
14        Board of Medical Specialties or Osteopathic or
15        by the Board with equivalent standards and
16        qualified by experienced or demonstrated
17        competence in the subject of the case.
18        A    Okay.
19        Q    The specialty of the physician expert
20        witness should be appropriate to subject matter
21        of the case.
22        A    Okay.
23        Q    All I asked was were you familiar with that?
24        A    Yes.
25        Q    Okay.   All right.
0065
 1        A    You know, and then you can figure out, we
 2   can put it aside and try to define what we think the
 3   subject matter of the case is.
 4        Q    Okay, we will do that.
 5             I know you've already preempted this ahead
 6   of time, but you clearly are not a cardiologist,
 7   correct?
 8        A    Right.
 9        Q    And beyond that you are not an
10   electrophysiologist which is a subspecialty
11   cardiologist who subspecializes in electrical
12   disturbances of the heart, correct?
13        A    Correct.
14        Q    And you're aware that the issue of this
15   case, obviously, is catheter ablation for atrial
16   fibrillation?
17        A    I don't know that that's the only issue in
18   this case.  I've been apprised that there are several
19   issues in this case.
20        Q    Okay.
21        A    So I don't know that that's necessarily just
22   the only issue.
23        Q    When you say you've been apprised of what
24   the issues are, tell me what you've been apprised.
25        A    I've been apprised by Attorney Kulwicki
0066
 1   about, you know, other aspects of the case other than
 2   just, you know, causation as it relates to the stroke
 3   and the management of the stroke.
 4             I think there's issues related to how long
 5   was he off anticoagulation before he was treated with
 6   the ablation?  What was the risk, benefit of doing the
 7   ablation in somebody like Mr. Sullivan?  What was he
 8   told?  What was he not told?  Where is the written
 9   consent for experimental therapy?  Was he included in
10   the databases?  Was he published?  Was he not
11   published?  I mean, you know, what was being done
12   experimental and not standard of care?  Was it a --
13   what was explained, etcetera?  What was not?  Who
14   explained it?  Who did?  You know, what was -- all of
15   that kind of stuff is what I -- I think the case
16   apparently evolved from what initially I got asked to
17   look at which was more restricted in terms of
18   causation and treatment of a stroke to these sorts of
19   issues that have evolved over time with the case.
20        Q    So when you were first approached, the issue
21   that was raised by Mr. Kulwicki was, as we've talked
22   about, the management of the stroke after it happened,
23   correct?
24        A    Correct, right.
25                  MR. KULWICKI:  And causation.
0067
 1        Q    And what caused the stroke?
 2        A    Right, what caused the stroke.  Right, yeah.
 3        Q    Okay.
 4             And then you say it has evolved into these
 5   additional issues about informed consent and other
 6   issues?
 7        A    Yes.
 8        Q    As far as what you planned to testify to, we
 9   have a report requirement as far as what an expert
10   will say at the time of trial based on their reports
11   that they sent.
12        A    Okay.
13        Q    And we have your report here, August 6,
14   2010.
15        A    Okay.
16        Q    And in your report that you've set forth you
17   give opinions on the issue of the anticoagulation and
18   the INR, correct?
19        A    Okay, yes.
20        Q    Beyond that issue of the anticoagulation and
21   the INR, it's my understanding you did not express any
22   other opinions in your letter of August 6, 2010, is
23   that correct?
24        A    Correct.
25        Q    Okay.
0068
 1             Now, I understand you're going to give an
 2   opinion as to the cause of the stroke?
 3        A    Okay.
 4        Q    Is that true or --
 5        A    Yeah, if asked, if asked.  I mean...
 6        Q    I mean, do you have an opinion as to the
 7   cause of the stroke?
 8        A    Yes.
 9        Q    Okay.
10             As far as saying whether or not Dr.
11   Burkhardt, in his management of this patient, let's
12   start first with the anticoagulation management, and
13   whether or not he met acceptable standards of care for
14   a cardiac electrophysiologist, it's fair that you will
15   not be giving an opinion on that?
16        A    Well, let's qualify that.  I mean, when you
17   say anticoagulation, do you mean the weeks or months
18   or days leading up to the procedure?   Do you mean the
19   intraprocedural anticoagulation or some combination of
20   both?  I mean, I'm trying to grapple with what you
21   mean by anticoagulation.
22        Q    Okay.
23        A    By an electrophysiologist.
24        Q    Do you plan to give an opinion at the time
25   of trial that Dr. David Burkhardt was negligent in his
0069
 1   management of the care of Mr. Sullivan?
 2        A    So that's a complicated question and I think
 3   that it depends on who was -- I think I alluded to it
 4   earlier, like who was quarterbacking the whole
 5   management of how long he should be off
 6   anticoagulation before the procedure?  Whose decision
 7   was it to not anticoagulate him during the procedure?
 8   Those sort of things I think are, you know, issues
 9   that have to get grappled with.  And whether if he
10   alone was responsible for determining how long Mr.
11   Sullivan was off his anticoagulation prior to the
12   ablation.  And if he alone made a decision,
13   unilaterally to not anticoagulate him during the
14   procedure while, apparently, there were people
15   anticoagulating during this procedure at Cleveland
16   Clinic and data being collected by the Cleveland
17   Clinic on outcomes with and without anticoagulation.
18   And did it, sort of without discussing it with Mr.
19   Sullivan or offering him options, and not documenting
20   that there is risks to that, in terms of clearly an
21   increased risk of stroke, then yeah, then I think
22   he's -- again, I'm not a cardiologist, but in terms of
23   you're asking me a question about, you know, the
24   issues related to anticoagulation decisions and
25   putting Mr. Sullivan at high risk of stroke -- higher
0070
 1   risk of stroke, then yeah, then I think that that
 2   stuff is potentially problematic.
 3        Q    Okay.
 4                  MR. KULWICKI:  You know,
 5        Anna, if you want I can weigh in on
 6        this.  And I know mixing the legal and
 7        the medical can be confusing to me, let
 8        alone a non-lawyer, but we don't intend
 9        to ask Dr. Levine standard of care
10        opinions at trial.
11                  So in fitting what you said
12        into standard of care issues, we don't
13        intend to ask you that.
14                  And I think we'll be faithful
15        to his report in the sense that we're,
16        obviously, going to ask causation
17        opinions, but we're also going to have
18        Dr. Levine weigh in about the choice
19        between having continuous
20        anticoagulation and with long-term
21        anticoagulant Coumadin or Warfarin,
22        that being a material choice with
23        material risks that the patient should
24        have been presented with.
25                  And I think he says that
0071
 1        pretty clearly in his report.  So I
 2        think those are really the two issues
 3        that we'll be asking Dr. Levine, and
 4        we'll limit it to that.
 5                  MS. CARULAS:  Okay.  Well,
 6        that will save me a significant amount
 7        of time.
 8                  MR. KULWICKI:  Yes.
 9                  MS. CARULAS:  So as far as --
10        because he does, as I read his report,
11        give some criticism, but it's a little
12        bit of the same nature of what we've
13        just had the discussion.
14                  So I want to make sure, at
15        the time of trial Dr. Levine will not
16        say that the judgment of Dr. Burkhardt
17        going forward with this procedure, as
18        he did, and in bridging this with
19        Heparin versus continuous Coumadin, he
20        will not say that's a deviation from
21        acceptable standard of care, correct?
22                  MR. KULWICKI:  Yeah, that's
23        correct, yeah.  We won't ask Dr. Levine
24        that question.
25                  MS. CARULAS:  Okay.
0072
 1                  MR. KULWICKI:  But at the
 2        same time, just so you understand, the
 3        choice needs to be put to the patient,
 4        I think, just as he says in the letter.
 5                  MS. CARULAS:  All right.
 6        Q    And let me just make sure before I go
 7   forward, Mr. Kulwicki says you're not going to get
 8   into that area?
 9        A    Okay.
10        Q    You would defer, obviously, to an
11   electrophysiologist on the issue of what is the
12   appropriate anticoagulation for a patient undergoing a
13   procedure such as this?
14        A    Provided it was known, right?  I mean, it
15   assumes that we -- if there's some knowledge --
16   protocol that's known that some standard of care that
17   is not experimental.
18        Q    Right.
19        A    That Is established or shown to be the way
20   to do things.
21        Q    Right.
22        A    Then yeah, no, I'm not going to argue about
23   that.
24        Q    All right.
25        A    But what I would argue about is the bigger
0073
 1   question, the broader question of informed consent and
 2   what was done to Mr. Sullivan was, was it under the
 3   rubric really of research?  Was it under the rubric of
 4   cutting edge care, but it's been demonstrated to be of
 5   benefit?  Was it under the rubric of, you know, we
 6   don't know what the best care is, and we're just
 7   trying different things, but we're really not calling
 8   it research?  I mean, there's different, sort of,
 9   schemes that could be brought to bear on how things
10   were done here.
11             And so to that degree, I could offer, if
12   asked or if allowed, would offer opinions as to what
13   really, in terms of constitutes research with human
14   subjects versus what is clinical care which is -- and
15   what is databasing for research versus clinical
16   purposes or quality purposes.
17        Q    Okay.  Tell --
18        A    Because that I am qualified to talk about.
19        Q    All right.
20             Tell me where in your report of August 6,
21   2010 you mention anything about this last subject you
22   talked about (handing).
23        A    (Witness perusing document.)
24             Well, the issue about not adequately being
25   anticoagulated and prior to and during the procedure
0074
 1   known to increase the risk of throw thromboembolism.
 2             So the whole issue of the judgment and the
 3   relationship to the role of anticoagulation and its
 4   lack of as a risk factor and causation of the stroke.
 5   And the thrombogenicity of the procedure as to whether
 6   those procedures were, in fact, either indicated or
 7   researched or appropriately discussed with the
 8   patient.  I don't specifically talk about that, but I
 9   talk about, you know, the issues related to the
10   procedures.
11        Q    Where?  I don't understand.  Where in the
12   report do you say anything about whether something is
13   a research subject or not and the issue of informed
14   consent?
15        A    Well, I don't specifically say those words
16   of informed consent or research, I just talk about
17   them as that they have known increased risk of
18   thromboembolism in procedures.  So going along with
19   that would assume that the care that would be provided
20   would deal with those issues to the fact -- to the
21   level that they weren't --
22             Right, if I have a patient, no matter who
23   the speciality is, and that is patient's undergoing
24   something that is known to increase their stroke risk,
25   okay, and that's not discussed or brought out and the
0075
 1   patient is making a decision based upon not knowing
 2   that it could increase his stroke risk or how much it
 3   increases the stroke risk, then I think that that's a
 4   problem to someone that's looking to prevent strokes,
 5   you know, as part of what I do.
 6        Q    Okay.  Let me --
 7        A    I think that if something is being done to a
 8   patient that is research and is not in clear clinical
 9   practice, that, as it relates to stroke risk from a
10   research procedure, there better be good documentation
11   of those procedures that allow for an understanding
12   and a meeting of the minds in writing to that end.
13        Q    Right.  You --
14        A    So I don't put into those terminologies,
15   obviously, but I -- as it relates to things that can
16   cause strokes or --
17             And then in terms of here:
18                  The patient has a right to such
19        information informed before the procedure to make
20        an informed decision to proceed in the face of
21        unnecessary risks.
22             All of that goes to what you're asking me
23   about.
24        Q    Okay.
25                  MR. KULWICKI:  Just so it's
0076
 1        clear, you were quoting from your
 2        report, at least the last line?
 3                  THE WITNESS:  Yeah, yeah,
 4        the last sentence for sure.
 5        A    That's all about, you know, understanding
 6   what's being done to me?  Is what's being done to me
 7   something that's been done for ten years and everybody
 8   does it and this is how it's done?  Or is it something
 9   that's only done at the Cleveland Clinic, and we do it
10   three different ways, but you're getting this way, but
11   we're really not telling you about the other two
12   options?  I mean, you know, what's going on?
13        Q    Okay.
14             So if I understand it, the only issue that
15   you will testify to is that you believe that Dr.
16   Burkhardt should have discussed with Mr. Sullivan the
17   options of anticoagulation during the procedure and
18   the significance?
19        A    No, I don't think that that's fair.  I think
20   we already talked about the preprocedure and how long
21   he had been of anticoagulation previous to the
22   procedure as well.   And I think we talked about
23   whether or not there were people at the Cleveland
24   Clinic that were doing this procedure during the same
25   time period with anticoagulation, whether there were
0077
 1   options to try different approaches.
 2             I mean, what -- I think the whole idea of
 3   informed consent was poorly documented in the chart.
 4   I couldn't find that he actually signed a written
 5   consent for a robot, for an experimental catheter, for
 6   the kind of procedure that we're taking you off
 7   anticoagulation, it will increase your risk of stroke
 8   and you understand that.  None of that stuff was --
 9        Q    Okay.
10             Where did the issue of not having an
11   informed -- first of all, the issue of not having a
12   written consent form, that is not anything that you've
13   set forth as a criticism in your report of August
14   2010, correct?
15        A    Not to that level of --
16        Q    Yes or no?  We're going to be here forever
17   literally, sir.  So yes or no, is there any statement
18   in your report of August 2010 that says, I am critical
19   of Dr. Burkhardt or the Cleveland Clinic for not
20   having a written intent informed consent form?
21        A    Well, I say it this way:
22                       The patient has a right to such
23        information in order to make an informed
24        decision.
25             So there's no clear documentation in the
0078
 1   chart that an informed decision was made.
 2        Q    I mean, we have the one line that you are
 3   referring to in your report.
 4        A    Yeah.  How many lines does it need to be?
 5        Q    Okay.
 6             Was the idea about the written informed
 7   consent something that had been raised with you by Mr.
 8   Kulwicki in his attorney work-product?
 9                  MR. KULWICKI:  Objection.
10                  Don't answer.
11                  Objection.  Don't answer the
12        question; I instruct the witness.
13                  MS. CARULAS:  Okay.
14                  MR. KULWICKI:  That's
15        attorney work-product.
16        Q    Prior to reading the reports of Chabon and
17   Moreno, had you been provided with any issues
18   regarding the written informed consent issue?
19                  MR. KULWICKI:  Objection.
20        That's just the same question.
21        Q    Do you know?
22        A    No.  I had -- specifically when I was
23   reviewing the records had asked.  You know, I said, I
24   can't find, you know, written informed consent.  Was
25   it like a page missing from my medical records or was
0079
 1   it -- there was not one, is it with some other
 2   documents I hadn't received?
 3             But given what he underwent --
 4                  MR. KULWICKI:  Is this his
 5        stuff (indicating)?
 6                  MS. CARULAS:  That's all my
 7        stuff.
 8                  MR. KULWICKI:  Oh sorry.
 9                  MS. CARULAS:  Actually this
10        maybe his (indicating).
11                  MR. KULWICKI:  I'm sorry, I
12        didn't mean to interrupt.
13        A    Given what went on and reading subsequently
14   in some of this literature about them publishing this
15   stuff and talking about safety and feasibility and all
16   these things that sounded very much like research to
17   me, it seems like, you know, he should have signed an
18   informed consent that he was being given treatment
19   that wasn't mainstream treatment or even proven
20   treatment.
21        Q    Okay.
22        A    So in terms of -- like I was saying, in
23   terms of -- this was things that were evolving or that
24   I was grappling with early on in the course of the
25   case, I mean...
0080
 1        Q    Okay.
 2             And I know you said you were grappling with
 3   it.
 4        A    Right.
 5        Q    Just so we're clear on the record, did you,
 6   in this letter of August 6, 2010, say you were
 7   critical of the Cleveland Clinic or Dr. Burkhardt for
 8   not having a written consent form, yes or no?
 9        A    When I talk about the quote from my report:
10                  The patient has a right to such
11        information in order to make an informed decision
12        about whether to proceed.
13             Basically, you know, the lay of the land is
14   that that's something that's put in writing often by
15   the patient signing and witnessing and dating if, in
16   fact, it's not, you know, routine standard of care
17   whether it's experimental or exploratory or being part
18   of a data collection process for a -- you know, a
19   registry or something that informed decision that I
20   use here clearly easily refers back to written.  I
21   mean, it doesn't say the word written --
22        Q    Thank you.  All right, now --
23        A    -- but it's part of the normal process that
24   people and their doctors go through.
25        Q    Okay.
0081
 1             Now, sir, have you ever performed an
 2   ablation procedure for A-Fib?
 3        A    No.
 4        Q    Have you ever watched the procedure?
 5        A    I may -- I think during one of the lectures
 6   I attended I may have seen some videotaping of it, you
 7   know, in the operating room or the --
 8        Q    Okay.
 9        A    A brief, but not like a lot of but, just...
10        Q    Okay.
11             You're not, by any means, qualified as an
12   expert to talk about a cardiac ablation procedure,
13   correct?
14        A    In and of itself the technical aspects, no.
15   Sure.
16        Q    Have you yourself ever conducted an informed
17   consent discussion with a patient who is about to
18   undergo an atrial fibrillation ablation?
19        A    No.  I have talked to patients of mine who
20   were considering it, and we talked about potential
21   risks and benefits, but I've not been the one to
22   obtain informed consent from them.
23        Q    And what have you told patients of yours in
24   general discussion as to the risks and benefits of the
25   procedure?
0082
 1        A    I think it depends on how symptomatic their
 2   atrial fibrillation is, how high a risk they are for
 3   stroke, what they -- how the ablation is going to be
 4   done, all of those sorts of things would go into an
 5   individual risk stratification.  There's no magic yes
 6   or no that I give anybody.
 7        Q    Right.  So --
 8        A    But I do tell them that I think it's still
 9   an evolving procedure, and that in some situations it
10   still maybe experimental.
11        Q    Okay.
12             Are you able to say, based upon your
13   education, training and experience, that this
14   procedure was, quote unquote, "experimental"?
15        A    In 2006?
16        Q    Yes.
17        A    I think it probably was.
18        Q    All right.
19        A    At least as how they were doing it then with
20   robots and other sort of catheter type of approaches
21   that were -- because the papers were coming out in
22   2007 about how they were -- their approaches and how
23   they were feasible or safe and things like that.
24             So the data in an article that comes out in
25   2007 certainly has to reflect data that was acquired
0083
 1   in 2006 or earlier.
 2        Q    Well, I mean, that's part of medicine, is
 3   it, that things are constantly evolving as far as
 4   knowledge whether it's the treatment of stroke,
 5   whether it's the treatment or atrial fibrillation --
 6        A    Right, but how do you get to that evolving
 7   knowledge on a patient-by-patient basis through
 8   research, studies and informed consent is how it leads
 9   to evolve.  So there's proper ways of evolving it and
10   improper ways of evolving it.
11        Q    I guess I need to find out here because I --
12   are you saying you think that the folks at Cleveland
13   Clinic and Dave Burkhardt were inappropriate in the
14   manner of doing this procedure and research that is
15   involved in the Cleveland Clinic?
16                  MR. KULWICKI:  I object.
17        That's a compound question.
18                  You can answer.
19        A    Well, that's what I'm grappling with as it
20   relates to what was it considered there.   Was it
21   considered -- or how would it be looked at anywhere
22   else in terms of, you know, Federal Laws of protecting
23   human subjects.  Were they doing research on Mr.
24   Sullivan without his consent?   Were they not -- were
25   they including him in publication without his consent?
0084
 1   Were they --
 2             I couldn't find him included in all the
 3   strokes early on, so was he selectively deleted for
 4   some reason from the article?  I mean, there's a lot
 5   of questions that come up, and I don't say that I know
 6   the answers to them all, but they certainly raise
 7   issues that we have to grapple with as it relates
 8   to -- you know, if a robot did his procedure and he
 9   wasn't told that a robot did his procedure, I mean,
10   what's that about?
11             And if he was told that this is standard of
12   care or that the risk is really no risk, you know,
13   versus, you know, there's a lot of risk would he have
14   made that decision?  Was he given the option to
15   continue anticoagulation or not?  Why was he off
16   anticoagulation for as long as he was before the
17   procedure?  I mean, there's a lot of things to grapple
18   with here.
19        Q    Okay.
20             And I understand you're saying you're
21   grappling with things --
22        A    Right, because --
23        Q    Wait.  There's --
24        A    -- I don't want to necessarily making
25   accusations, per se, about intent or motive which is
0085
 1   what I think your question went to.
 2        Q    Okay.  And that's all I need to find.
 3             Do you understand this is my opportunity --
 4        A    Sure.
 5        Q    -- to come here, take your discovery
 6   deposition, go back to the folks at the Cleveland
 7   Clinic and tell them, This is what Dr. Levine is
 8   saying.
 9        A    Sure.
10        Q    Okay.  And I need to know -- I understand
11   you're grappling with things, I need to know what it
12   is you propose to testify to at the time of trial.
13        A    Sure.
14        Q    And you said a minute ago, These may raise
15   questions, I don't have the answers.
16        A    Well, I don't -- I can't get in someone's
17   mind, obviously, to know what intent is or motive or
18   what was going on five years ago at the Cleveland
19   Clinic when, you know, Dr. Burkhardt and Mr. Sullivan
20   were, you know, dealing with each other.
21        Q    All right.
22        A    I wasn't there.
23        Q    Okay.
24        A    All I have to do is base it on records, you
25   know, and testimony of Dr. Burkhardt and, you know,
0086
 1   that's -- I -- and so what my familiarity over
 2   twenty-some-odd years is of research and looking at
 3   the -- where things are being published and when, and
 4   what they're saying, and how the evolution of the
 5   field, as you talk about it, was evolving in an area
 6   where, yes, it's outside of my area of expertise, I'm
 7   not a cardiologist.
 8             But, you know, if you're publishing in 2007
 9   that what was done to Mr. Sullivan was sort of safe
10   and feasible, and that we can use things, and here's
11   our complication rates and our outcomes from the
12   strokes when they happen, and that data is being
13   acquired in 2006, five, four, whatever the number of
14   years were that they were being acquired, so that's
15   research.   Because, obviously, if something's safe
16   and effective and proven such you wouldn't have to
17   write a paper in 2007 saying, What we're doing seems
18   to be safe and effective.
19             Well, does Mr. Sullivan know that they
20   were -- he was involved in early phase issues related
21   to safety and efficacy and risks and benefits?  And
22   that's what I'm grappling with.  And maybe he was, and
23   maybe it was all done verbally, you know, but there's
24   no written documentation.
25             And the way I've sort of been trained, both
0087
 1   from a legal side and as a medical doc, if it ain't
 2   documented, it ain't done.
 3             Now, if somebody comes along with new
 4   testimony and says, Oh, you know, it was, blah, blah,
 5   blah, and that's why we have witnesses on consent
 6   forms so if someone -- you know, someone say yes and
 7   someone says no, there's a third person that will say
 8   yes or no.
 9        Q    Okay.
10             And so I think what you're saying is there's
11   a factual -- maybe a factual dispute, correct?
12        A    Could be.
13        Q    Between -- you've not been provided with Mr.
14   Sullivan's testimony as to what he was told, correct?
15        A    I don't think so.
16        Q    We have Dr. Burkhardt's testimony?
17        A    Right.
18        Q    And you saw that he did have an extensive
19   discussion with Mr. Sullivan as far as the risks and
20   benefits?
21        A    That's what he says, right.
22        Q    Okay.
23             You, as you sit here today, you never knew
24   Dr. Burkhardt before this case?
25        A    No, right.
0088
 1        Q    Because you're not in the same field, had
 2   never heard of him by reputation?
 3        A    Right.
 4        Q    You, as you sit here, Dr. Levine, are not
 5   questioning Dr. Burkhardt's integrity?
 6        A    No.
 7                  MR. KULWICKI:  Objection.
 8                  You can answer.
 9        A    Right.
10        Q    All right.
11             So have you been provided with the testimony
12   of Dr. Kanj, K-A-N-J; you've not, true?
13        A    I don't think so.  I might have, but I can't
14   recall.  I don't think so.
15        Q    All right.
16             Have you been provided with the testimony of
17   Stacy Poe, P-O-E?
18        A    I'd have to go back and check again.  It may
19   have been that these deps were in the back of the
20   medical records, but -- so I can't recall.
21        Q    As you sit here today, you didn't put in
22   your --
23        A    I didn't put it in that (indicating).  It
24   may have come subsequent, but I don't recall it.  I
25   don't have an independent recollection of it.
0089
 1        Q    Of what she said as far as discussions and
 2   so forth?
 3        A    Right.
 4        Q    Do you know whether or not any of the
 5   physicians from Hawaii, before the procedure, had any
 6   discussions with Mr. Sullivan about the procedure,
 7   what its risks were, what its benefits were, that sort
 8   of thing?
 9        A    I don't know if they -- I mean, whatever was
10   documented in the records.  I mean, there could have
11   been things that were done that were not documented,
12   but I would not know about that.
13        Q    Sure.
14             As far as what was documented, as you sit
15   here today --
16        A    I don't have an independent recollection of
17   what was said in the notes about the procedures
18   that -- maybe you should look at it because he was
19   having -- there may have been something about, you
20   know, some exercise tolerance issues with his biking
21   and, you know, maybe his internist or cardiologist
22   said, you know, maybe go to the Cleveland Clinic
23   because they have something there or maybe he did that
24   on his own.  I can't recall how it turned out that he
25   went the path he went, but...
0090
 1        Q    As you sit here right now, you don't
 2   remember what the documentation was of any of the
 3   doctors from Hawaii, and what they said they told --
 4   and documented in the records, they told Mr. Sullivan
 5   about the procedure, the risks, the benefits?
 6        A    I don't have an independent recollection of
 7   that.
 8        Q    So what you're doing, correct me if I'm
 9   wrong, you're raising that, perhaps, this maybe an
10   issue of informed consent for a jury to determine,
11   correct?
12        A    Right.
13                  MR. KULWICKI:  Objection.
14                  You can answer.
15                  (WHEREUPON, there was a brief
16        interruption.)
17        Q    And as you --
18        A    Right.  I think that there is issues related
19   to what was done, what wasn't done, what's under the
20   rubric of research versus clinical care.
21        Q    All right.
22        A    I think those are decisions that are going
23   to have to be made by somebody, a jury or something,
24   but I know that, you know, I'm grappling with them
25   because, you know, I think that -- but I certainly
0091
 1   have concerns.
 2             I mean, it's one thing to grapple and be
 3   minimally concerned, and it's another to grapple and
 4   have real concerns.
 5        Q    All right.
 6        A    And I have some real concerns.  Unless I had
 7   seen -- you know, if there was a written informed
 8   consent that was signed, dated, timed, witnessed that
 9   said, you know, What we're doing is -- we don't know
10   how easy or safe is to anticoagulate or not
11   anticoagulate during this procedure, and whether
12   robots are better or not better, or this catheter is
13   better than that catheter, and we want to put you in
14   one of these groups and study it, you know, I don't
15   see that.
16        Q    Okay.
17             Do you know whether or not Ohio law requires
18   a written informed consent?
19        A    A written informed consent for research or
20   what are we talking about?  A written informed consent
21   for what?
22        Q    For a procedure, for undergoing a procedure.
23        A    I think it depends on the procedure.  I
24   don't know what Ohio law is.  I know that Federal law
25   requires a written informed consent for anything you
0092
 1   do that's considered research, it's experimental.  And
 2   I think that trumps any -- again, I'm not a lawyer so
 3   I shouldn't say, but I would -- I might image it might
 4   trump State law for generic informed consent for any
 5   given procedure, per se.
 6        Q    All right.
 7             As far as whether or not Dr. Burkhardt
 8   provided a valid informed consent to Mr. Sullivan
 9   under Ohio law you understand is a question of fact
10   for the jury?
11                  MR. KULWICKI:  I'll object.
12                  You can answer.
13        A    I don't know.   I mean, because I don't know
14   what that -- what Ohio law is ruling on.  Is it ruling
15   on a procedure that's been proven to be safe and
16   effective, and we're just getting you to verbally say,
17   okay, like your tonsils out or something?  Or does is
18   it cover -- does it have jurisdiction over what the
19   Federal issue are as to if it's an experimental
20   procedure or an unproven treatment or it's something
21   that the patient is going to have options for that's
22   not being discussed otherwise?  I don't know.
23   That's -- so I can't answer fully.
24        Q    All right.
25             So fair enough that you are not rendering an
0093
 1   opinion in this case, and will not, whether it's in
 2   May or at some point, to a jury that, in your opinion,
 3   Dr. Levine, the neurologist, is saying that the
 4   informed consent provided by Dr. Burkhardt was
 5   negligent; is that true?
 6        A    Well --
 7                  MR. KULWICKI:  Well,
 8        objection.  I object.
 9                  Anna, you misspoke because
10        you used the wrong name at the wrong
11        time.  So at a minimum we reframe the
12        question.
13                  But that question you've
14        hybridized informed consent and
15        negligence, and they're two distinct
16        causes of action, and we've already
17        said he's not going to testify on the
18        negligence.
19                  I mean, I don't want to coach
20        here, but I think it's an unfair
21        question.
22        Q    Dr. Levine, I did not see anywhere in your
23   report of August 6, 2010 where you said I believe that
24   Dr. Burkhardt did not provide an adequate informed
25   consent to Mr. Sullivan under Ohio law?
0094
 1                  MR. KULWICKI:  Objection;
 2        asked and answered.
 3        Q    Is that true?
 4        A    Can I look at my report again?  And I'll
 5   read again what I wrote in the report.
 6        Q    Yes.
 7        A    I said -- I wrote, and I'll quote:
 8                  Further Mr. Sullivan was left
 9        unprotected for stroke prevention by not having
10        an INR between 2 and 3.5 as planned for the
11        procedure thus placing him at higher risk of
12        cardioembolic stroke.
13                  Mr. Sullivan should have been informed
14        before the procedure that his INR was less than
15        optimal for the procedure, and that, as a result,
16        he was at an increased risk of stroke.
17                  The patient has a right to such
18        information in order to make an informed decision
19        about whether to proceed in the face of
20        unnecessary risks.
21                  He suffered a large middle cerebral
22        artery infarction as a result of this procedure
23        in the setting of an inadequate INR.
24             So I think I do address the issue about
25   decision making and what he -- was he was told or not
0095
 1   told in terms of seeing at least written in
 2   documentation.
 3             Now if you tell me Ohio law says that can be
 4   done verbally and there doesn't have to be a paper
 5   trail for it, but if it's considered by whoever's
 6   going to decide that this is not research, that this
 7   is just clinical practice, that's one issue.
 8             However, if it's decided that this is
 9   research and, therefore, Federal law states you need
10   written informed consent for research, then for sure
11   he did not get informed decision appropriate because I
12   couldn't find, unless I can be provided for it, his
13   consent form, written consent that he signed and was
14   witnessed and dated and all that.
15        Q    Okay.
16             So I want you to assume --
17        A    Okay.
18        Q    -- that Ohio law does not require a written
19   informed consent document for a surgical procedure.
20        A    Research or clinical?
21        Q    We'll talk clinical.
22        A    Clinical procedure?
23        Q    Right.
24        A    Okay.
25        Q    Okay.
0096
 1             So assuming that?
 2        A    Okay.
 3        Q    Then you understand it comes to down to a
 4   factual dispute, was he told the risks and benefits
 5   about the procedure or was he not?
 6        A    Okay.
 7        Q    Okay.
 8        A    If this was considered a clinical procedure,
 9   right.
10        Q    All right.
11             So assuming this was a clinical procedure,
12   we're talking about clinical procedure.
13        A    Okay.
14        Q    And --
15        A    Non-research?
16        Q    Right.  Okay?
17        A    Okay.
18        Q    Then you are not saying, in your opinion,
19   Dr. Burkhardt did not give adequate informed consent?
20                  MR. KULWICKI:  Well,
21        objection.  I mean, he just read to
22        you.  I mean, I don't know how much
23        clearer he could have been, he just
24        read to you.
25                  MS. CARULAS:  Okay.
0097
 1        Q    So let me just cut to the chase.
 2             Your issue here is on the INR you think that
 3   Mr. Sullivan -- at least according to your report
 4   here, Mr. --
 5        A    That's one factor.  The procedure is also
 6   mentioned in there not just the INR.  It's not just
 7   the INR.
 8        Q    Okay.
 9        A    We're not putting blinders on and saying
10   it's only the INR, right?  We're talking about how
11   long was he subtherapeutic?  This procedure, how this
12   procedure was done.  What was known at the time of the
13   procedure, risks benefits?  There's -- it's all in
14   there.  It's complicated.  That's why I said
15   complicated.
16             It's not just the INR.  Don't pigeonhole me
17   into just the INR.  It's not just about the INR.
18        Q    Okay.
19        A    And I didn't write just about the INR.
20        Q    Wow, okay.
21                  (WHEREUPON, there was a brief
22        interruption.)
23                  (WHEREUPON, a brief recess
24        was taken after which the following
25        transpired:)
0098
 1        Q    In fairness to you, I'm going to let you --
 2   because I know Mr. Kulwicki didn't provide you with
 3   the report of Dr. Callans, who I will represent to
 4   you, other than Dr. Burkhardt and others, is the only
 5   electrophysiologist testifying in this case, okay?
 6             So before we further on talking things, I'd
 7   like to give you the opportunity at least to read this
 8   (handing).
 9        A    Okay.
10        Q    Okay.
11        A    (Witness perusing document.)
12        Q    Okay.   You took your time and read through
13   Dr. Callans' report.   Prior to reading this report,
14   had you ever heard of Dr. Callans, C-A-L-L-A-N-S --
15        A    No.
16        Q    -- at University of Pennsylvania?
17        A    No.
18        Q    And had you ever heard of Francis
19   Marchinski, M-A-R-C-H-I-N-S-K-I, also at U Penn?
20        A    No.
21        Q    As you read this, what are your thoughts as
22   you read his report?
23        A    Well, my thoughts are that he says that
24   there's documentation of risks and benefits discussed
25   by Poe and by the cardiologist with Mr. Sullivan by
0099
 1   telephone and in person on the day or the day before
 2   the procedure.
 3             That -- he says that Burkhardt was doing his
 4   usual practice with these were things, but that
 5   doesn't explain whether that usual practice is
 6   research based or not.  Just because you're doing it
 7   doesn't mean that it's proven or that it's considered
 8   standard of care necessarily.  So I don't know what to
 9   make that of.   I mean, just because you're doing
10   something doesn't mean it's not research or the
11   patient needs more informed consent possibly.
12             You know, that the procedure was of no
13   consequence for in terms of increasing his risk of
14   stroke or whatever.  I mean, I don't know how you can
15   genuinely say that.  We have that where he talks about
16   some line that was a little confusing.
17                  No impact of Dr. Burkhardt's
18        performance of the catheter ablation procedure or
19        the subtherapeutic INR.
20             Well, I mean, the guy stroked from it, so I
21   don't know how you can say there was no impact from
22   it.
23             And he says upfront:
24                  Doesn't eliminate the risk of
25        periprocedural stroke by putting people on
0100
 1        uninterrupted Warfarin.
 2             But it's a question of it reduces it.  So
 3   the issue again is risk benefit and how much is it
 4   still a risk factor.  But to say that it had no impact
 5   I think is -- I can't say that that's -- you know, it
 6   sounds a little disingenuous.
 7             And that:
 8                  Stroke is a recognized complication of
 9        the procedure, and that strategies are used to
10        decrease the risk, but can't eliminate it.
11             Okay, fair enough.
12        Q    You agree with that part at least?
13        A    Yeah.
14                  MR. KULWICKI:  Objection.
15        Q    Okay.
16             And I mean, you're entitled to your opinion
17   and I just wanted to, before we go further, to at
18   least --
19        A    Sure, I understand.
20        Q    -- give you the perspective because I know
21   early on you said you would defer to an
22   electrophysiologist so --
23        A    Not on everything.  Again, let's not be
24   global.  I mean, I would defer on certain technical
25   issues related to procedure, but not about necessarily
0101
 1   informed consent or what's research and what's not
 2   research, and what the risks of stroke are and aren't,
 3   those sorts of things.
 4        Q    Okay.
 5             I'm not sure if I asked you this or not, but
 6   are you saying -- and I need to find out before I
 7   leave here today.
 8             I want you to assume that I went out about
 9   two weeks ago or so and deposed this Dr. Moreno, who
10   is the ethicist, and I asked him, Do you believe any
11   of the research that was being done at the Cleveland
12   Clinic was in any way inappropriate or unethical, and
13   he said, No, this is good people trying to do good
14   things.
15             Do you, Dr. Levine, plan to testify in
16   Cleveland, Ohio that any of the research activity by
17   the folks at the Cleveland Clinic was inappropriate?
18                  MR. KULWICKI:  You mean aside
19        from the informed consent?
20        A    Is this a global question --
21        Q    Yes.
22        A    Or specific to this case?
23        Q    I want a global issue as far as the research
24   that was being conducted in this case.
25             Do you plan to give opinions on --
0102
 1        A    In this case?
 2        Q    Well...
 3                  MR. KULWICKI:  I just want to
 4        get an objection on the record because
 5        I don't think that's what Moreno said.
 6        I also object to the form of the
 7        question.
 8                  But go ahead, doctor.  If you
 9        can, answer go ahead.
10        A    So if you could clarify.   Do you mean just
11   what the Cleveland Clinic does in general or what the
12   Cleveland Clinic did in this case through Burkhardt in
13   terms of was there truly informed consent for a
14   procedure that was not necessarily proven or was
15   considered research?  Or what did the Cleveland Clinic
16   consider research or not?  I mean, I'm trying to
17   grapple with what you mean by your question, I guess.
18        Q    I want to know what you, Dr. Levine, are
19   going to say at the time of trial.
20        A    Depends what I'm asked, right?  I only going
21   to answer questions.  So --
22        Q    Okay.
23        A    -- depending on what the question is --
24        Q    So tell me do you plan to testify at the
25   time of trial that Dr. David Burkhardt was negligent,
0103
 1   yes or no?
 2             I know Mr. Kulwicki says he's not going to
 3   raise that with you, but it's so overbroad I need to
 4   find out from you.  I want to know whether you plan to
 5   ask it or not.  I want to know what Steven Levine is
 6   going to say at the time of trial.
 7                  MR. KULWICKI:  Well, I
 8        object; it's asked and answered.
 9                  Doctor, you can answer.
10        A    Again, it's going to be what is going to be
11   defined as research or not, what the facts of the case
12   are.  Is what Dr. Burkhardt did or his fellow, as it
13   involved the procedure, was that considered research
14   or not?
15        Q    All right.  And --
16        A    And if it was considered research, then
17   unless someone can show me a signed informed consent,
18   then there was a breach of doing research without
19   proper consent.
20        Q    Okay.  All right.
21        A    I mean, so that's pretty clear.  I mean, I
22   don't -- again, no intent, no -- you know, what was on
23   his mind about good people doing good things, but I
24   mean, you know, by Federal law you got to have written
25   informed consent if what you're doing is considered
0104
 1   research.   If it's decided that this wasn't research,
 2   okay, and then maybe --
 3        Q    Okay.
 4        A    -- Ohio law trumps Federal law.  I mean, you
 5   know, I'm not a lawyer so I mean --
 6        Q    Okay.
 7        A    -- the procedure.  But to me I'm grappling.
 8   That's one of the issues I'm grappling with is, you
 9   know, in 2006 what were they doing?  And it certainly
10   looks like it was research to me.  Again, I'm not the
11   end-all be-all authority, but it certainly -- based on
12   the timing of the publications and what was being said
13   in those publications based on data that was being
14   collected, you know, what's going on?  And why were
15   there people who had had strokes before and after Mr.
16   Sullivan in the papers, but he wasn't in there?
17   Unless someone could show me where he is, what's going
18   on?
19        Q    All right.
20        A    So those are the issues that -- so for me to
21   just globally give you a yes, no answer, that's a very
22   difficult thing.  I can't -- I don't think that I can
23   do that.
24        Q    All right.
25             So you said a minute ago you didn't think
0105
 1   there was any intent, and so you are not --
 2        A    Well, I can't get inside someone's mind,
 3   what their intent is to do, so I can't -- you know.
 4        Q    Okay.
 5        A    I'm not -- I'm going to give people the
 6   benefit of the doubt, I'm not going to say, Oh no, I
 7   think he was deliberately trying to get away with
 8   doing research without consent.  I don't think that
 9   that's necessarily what's going on.
10        Q    Okay.
11             So then you say the question that you're
12   grappling with is, Is this research or not?  Okay.
13             As you sit here today, have you come to a
14   conclusion or are you saying that's something you are
15   still grappling with?
16        A    Well, I think there's -- I think there's
17   concern because what the timing of the papers, and
18   what was known, and what was said, and what was done.
19   And so even with the cardiologist from Penn saying
20   this was his usual practice, if your usual practice is
21   putting people in research trials, okay, but that's --
22   that's all he left it at, he just said it's his usual
23   practice, but we didn't get clarification of whether
24   that's research or not.  And he didn't address that, I
25   don't think -- well, he said, Well, standard of
0106
 1   care.
 2             But, you know, it is standard of care if you
 3   do research to put patients into trial after informed
 4   consent.  We do that at the time.  I've been doing
 5   that for twenty-five years.
 6        Q    Right, okay.
 7        A    So if you're going to put Mr. Sullivan in a
 8   database and that says, Oh, let's see what would
 9   happen to the first hundred patients to get robotics
10   or the first hundred patients so, whatever, that don't
11   get adequate anticoagulation during the procedure or
12   get some new catheter proached or some robot punctures
13   the septum to -- you know, whatever's going on then is
14   that clinical care or research?   I'm not sure I'm the
15   best person to define it.  I can weigh in on it based
16   on timing and what it looks like, but, you know, I'm
17   not a cardiologist, and I can't speak to what the
18   standard of care for atrial ablation was as a
19   non-cardiologist as it relates to standard practice
20   and what's acceptable or not without a consent form.
21        Q    Okay, good.
22             Now, you've made the statement that Mr.
23   Sullivan stroked because of the low INR?
24        A    I didn't say that.
25        Q    Okay.  Then I --
0107
 1        A    I said that's one factor.  It's in my
 2   report.  It's the combination of the low INR and the
 3   procedure.
 4        Q    Okay.
 5             So having atrial fibrillation itself is a
 6   risk factor for stroke --
 7        A    Correct.
 8        Q    -- correct?
 9             And what is the percentage risk of someone
10   with atrial fibrillation to have a stroke?
11        A    So it depends.  We have a risk
12   stratification scheme called a CHADS2 score, and he
13   was zero and so his risk was is 1.9 percent per year.
14        Q    Okay.
15        A    So that means we can figure out, right,
16   what, you know, on any given day what that risk is.
17             So, yeah, so over the course of a year he
18   has a 1 in 50 chance.  On the course of any given day
19   during that year it's going to be going to 1 over 50
20   times 365, it's going to be very, very small.
21             So then he goes and has a procedure with a
22   low INR and two and three hours later has a stroke,
23   and they puncture his septum, they mucked around in
24   there, and dealing with things that are known to be
25   prothrombic and pro increased stroke risk, it's -- you
0108
 1   know, you can't say that it's just the procedure or
 2   just the INR being low, but it's, obviously, whatever
 3   factors all came together at that point in time that
 4   increased his stroke risk and contributed to the
 5   stroke which was the low INR conjunction with this
 6   procedure being done and that's why he stroked.
 7        Q    Okay.
 8             The CHADS2 score, is that something that any
 9   neurologist that deals with strokes knows about?
10        A    I think so.
11        Q    If a neurologist was not familiar -- if a
12   stroke neurologist would not be familiar with the
13   CHADS2 score, would that surprise you?
14        A    A stroke neurologist?
15        Q    Yes.
16        A    Yeah, I would be a little surprised about
17   that.
18        Q    Okay.
19        A    I think so.  I think because -- if I recall
20   I think there were even questions on it on our stroke
21   boards.
22        Q    Okay.
23        A    But...
24        Q    And any neurologist who would give an
25   opinion as to a cause of a stroke, you would feel it's
0109
 1   important that they know about the CHADS2 score?
 2        A    Cause of a stroke in general or cause of Mr.
 3   Sullivan's stroke?  I mean --
 4        Q    Cause of Mr. Sullivan's stroke.
 5             For any neurologist to give an opinion as to
 6   the cause of Mr. Sullivan's --
 7        A    I don't know that they necessarily have to
 8   know the CHADS2 score or the numbers behind it to give
 9   an opinion about the mechanism of the stroke.  No, I
10   don't think there's necessarily a link there.
11        Q    Okay.  Put aside the mechanism.
12        A    Well, that's what you're asking, cause of
13   the stroke.  Cause is mechanism.
14        Q    Okay.  Anyway that's fine.
15             Are you aware whether or not there are any
16   other neurologists who have looked at this case?
17        A    Well, only from the Penn cardiologist whose
18   report you asked me to read where I saw that there was
19   a John Conomy, C-O-N-O-M-Y, that was involved.
20        Q    And do you know Dr. Conomy?
21        A    I know of him, yeah.  I've seen him at
22   meetings, and I've seen him, you know, in various
23   medical/legal cases as well.
24        Q    Have the two of you been on the same side
25   together or opposing sides, what's your experience?
0110
 1        A    More opposite, occasional same.
 2        Q    Okay.
 3             And what has your experience been with Mr.
 4   Conomy and his opinions?
 5        A    I don't know what you mean by that.
 6        Q    All right.  Let me ask you:
 7             As far as this issue of -- do you understand
 8   that even today cardiac electrophysiologist perform
 9   this procedure by bridging patients with Heparin as
10   opposed to having the patients on continuous Coumadin
11   with therapeutic INR?
12                  MR. KULWICKI:  When you say,
13        this procedure, you mean exactly how it
14        was done with Sullivan or are you
15        talking about the more generic sort of
16        form?
17                  MS. CARULAS:  Well, he
18        doesn't know the difference of the
19        techniques.
20        Q    I'm talking about atrial fibrillation
21   ablation.
22        A    Well, there are lots of the different
23   techniques, right?  I mean, there's with a robot,
24   without a robot, whether you do it with different kind
25   of catheters, where you ablate, you know, those sort
0111
 1   of things.
 2        Q    You can't comment on any of theme?
 3        A    No.  I just know that there's various
 4   approaches.  There's more than one way to skin a cat,
 5   right, so --
 6        Q    Of course.
 7             Are you aware --
 8        A    But I'm aware that certain ways of doing it
 9   may contribute to patients being at higher risk for
10   stroke or complications than other ways of doing it.
11        Q    Okay.
12             Are you aware of the at least two different
13   approaches or arms as far as anticoagulation for an
14   atrial fibrillation ablation?
15        A    You mean just Heparin or using continuous
16   Coumadin throughout the procedure?
17        Q    Yes.
18        A    Is that what you mean?
19        Q    Yes.
20        A    Yeah, I'm aware that there is those
21   different ways of doing it.
22        Q    And when a patient is taken off of the
23   Coumadin days before the procedure and then they are
24   bridged during the procedure with Heparin, those
25   patients do not have a therapeutic INR.
0112
 1        A    Right, because they've been taken off their
 2   Coumadin.
 3        Q    Okay.
 4        A    Right.
 5        Q    All right.
 6             Just so I'm clear, because in your report
 7   you are not going to say that -- we know in this
 8   particular case that Dr. Burkhardt performed this
 9   procedure using the bridge of Heparin, correct?
10        A    Yes.
11        Q    You understand, from reading Dr. Callans'
12   report, that that is an appropriate acceptable
13   approach, correct?
14                  MR. KULWICKI:  Objection.
15                  You can answer it.
16        A    Well, I mean the issue is back in 2006 when
17   this was taking place.
18        Q    Yes.
19        A    Was it standard?  Was it a research
20   question?  Was it something that was going to be
21   published and compared to other things and was going
22   to be dealt with that way?
23                  THE WITNESS:  Excuse me one
24        second.  Can I just get this phone
25        call?
0113
 1                  MS. CARULAS:  Yes.
 2                  MR. KULWICKI:  Let's go off
 3        the record.
 4                  (Discussion held off the
 5        record.)
 6                  MS. CARULAS:  Can you just
 7        tell me what my last question is and
 8        the answer?
 9                  (WHEREUPON, the requested
10        question and answer were read back by
11        the court reporter.)
12        Q    So again, you said there's an issue of
13   whether or not this was going to be research or not.
14             You do not know whether or not Mr. Sullivan
15   was actually enrolled in a research study?
16        A    I don't know because I didn't see any
17   informed consent signed.
18        Q    Okay.
19        A    But I do know that things that were being
20   done to Mr. Sullivan were being published about their
21   feasibility and efficacy and outcomes from the same
22   authors in the subsequent years that included outcomes
23   of patients that didn't seem to include Mr. Sullivan.
24   So again, I'm grappling, what's that about?
25        Q    Okay.
0114
 1             Tell me, did you interact with any of the
 2   cardiac electrophysiologists at Sinai?
 3        A    Sure.
 4        Q    Who in particular there?
 5        A    I can't remember his name, but the guy just
 6   came down from Harvard that was there for a couple of
 7   years.  I can probably get it on a multiple-choice
 8   question, but not a fill-in-the-blank question.
 9        Q    Okay.
10             So as you sit here today, you're unable to
11   tell me who any of the cardiac electrophysiologists
12   are at Mount Sinai?
13        A    No, I could on a multiple-choice question, I
14   couldn't on a fill-in-the-blank question.  I'm
15   blocking on his name, but I would recognize it if I
16   heard it.  But we've had him give lectures on this and
17   we've talked with him about different things and had
18   patients in common, so...
19        Q    Okay.
20        A    So I do interact with him.
21        Q    Do you interact with any of the upstate SUNY
22   electrophysiologists?
23        A    No.
24        Q    Would you know who any of them are?
25        A    No.
0115
 1        Q    Do you interact with any of the Downstate
 2   SUNY electrophysiologists at your current hospital
 3   which is Brooklyn Hospital?
 4        A    University Hospital of Brooklyn.
 5        Q    Yes.
 6        A    Right.   So have I -- I have not -- I've
 7   interacted with cardiologists, but not specifically
 8   electrophysiologists.
 9        Q    Are you, as you sit here today, able to name
10   who the chief of cardiac electrophysiologists is at
11   your hospital?
12        A    Only just Chief of Cardiologist, Chief of
13   Medicine and several cardiologists, but I do not know
14   who the chief of electro cardiology -- physiology is
15   within cardiology is.  No, I don't.
16        Q    And are you able to name any of the
17   electrophysiologists at your hospital, the names?
18        A    No, not that I recall off the top of my
19   head.
20        Q    You made a statement that:
21                  The decision was made not to
22        anticoagulate Mr. Sullivan during the procedure.
23        A    With his Coumadin.
24        Q    Okay.
25             You do know, from reading Mr. Callans'
0116
 1   report, that he was anticoagulated during the
 2   procedure?
 3        A    With Heparin.
 4        Q    Right.
 5        A    Right.
 6        Q    And prior to reading Dr. Callans' report,
 7   were you aware of that?
 8        A    Yes.  He was measured by the ACT, I believe.
 9        Q    And do you know currently at your hospital
10   whether or not patients are maintained on Coumadin
11   continuously with a therapeutic INR or whether or not
12   they maybe taken off the Coumadin, not have the
13   therapeutic INR and bridged with Heparin?
14                  MR. KULWICKI:  Objection.
15                  You can answer.
16        A    I don't know.
17        Q    Would it surprise you if currently the
18   electrophysiologists at your hospital instruct their
19   patients that you may also be asked to stop taking
20   your anticlotting medication to prevent bleeding
21   during the procedure?
22                  MR. KULWICKI:  Objection.
23                  You can answer.
24        A    Do I know that?
25        Q    Right.
0117
 1        A    I don't know what the -- again, like I said,
 2   I don't know what their protocols are, what they're
 3   doing.
 4        Q    Okay.
 5             And I know you don't know what their
 6   protocols are.  I guess the question is would it
 7   surprise you if the --
 8        A    I think it depends also for how long.   I
 9   mean...
10        Q    Okay.
11             And you can't weigh into that, again, true?
12   I mean --
13        A    I don't know -- right.  I mean, in 2011,
14   which is now five years after the Sullivan case, what
15   the current, accepted guidelines and the standards of
16   practice are for this procedure, and whether -- what
17   aspect of this procedure are now considered
18   commonplace or clinical versus research.  I mean, I
19   don't -- I don't keep up with that.
20        Q    All right.
21             And so what the standard of care was back in
22   August of 2006 --
23        A    Right.
24        Q    -- as far as whether or not to keep them on
25   continuous Coumadin with a therapeutic INR or to put
0118
 1   them on bridge with Heparin, as we've talked about,
 2   you're not qualified to say what the standard of care
 3   was back in August of 2006, correct?
 4                  MR. KULWICKI:  Objection.
 5        Asked and answered at least a dozen
 6        times and stipulated to.
 7                  MS. CARULAS:  Okay.
 8        Q    So the answer is yes, correct?
 9        A    So the answer is yes meaning?
10        Q    You cannot --
11                  MS. CARULAS:  Would you read
12        the question back, please?
13             (WHEREUPON, the requested
14        questions was read back by the court
15        reporter.)
16        A    Right.  I don't know what the standard of
17   care necessarily was.  I think it's a question of what
18   was done to him in terms of his whole -- you know, all
19   the things as it relates to the peri and
20   intraprocedural things was that something that was
21   what clinic -- you know, proven clinical efficacy or
22   was it being databased?  Was it considered research?
23   We went through this several times.
24        Q    Right.
25             And as far as what the standard of care is
0119
 1   now in the electro cardiologist field as to whether or
 2   not it's appropriate to do this procedure with
 3   continuous Coumadin and a therapeutic INR or to
 4   discontinue the Coumadin, not have a therapeutic INR
 5   and bridge with Heparin, you -- same answer I
 6   assume -- are unable to give an opinion as to what the
 7   standard of care is currently?
 8                  MR. KULWICKI:  Same
 9        objection.
10                  You can answer.
11        A    I -- yeah.  I think that I have -- it's not
12   something that I've been following very carefully, and
13   as a non-cardiologist it's not something that I would
14   be able to say I can be an expert in that level of
15   standard of care, so...
16        Q    Okay.
17             And I know you wrote your report in August
18   of this last year, 2010.  You were already moved over
19   to SUNY by that point, correct?
20        A    Four or five weeks.
21        Q    Okay.
22             When Mr. Kulwicki first contacted you, were
23   you still at Sinai?
24        A    Yes.
25        Q    Do you know what the physicians, the
0120
 1   electrophysiologist at Sinai were doing as far as
 2   whether or not they were choosing the arm of a
 3   continuous Coumadin with a therapeutic INR or whether
 4   they were stopping the Coumadin days before and
 5   bridging with Heparin?
 6                  MR. KULWICKI:  Objection.
 7                  He already answered; you
 8        asked him that question.
 9                  MS. CARULAS:  I asked him
10        about SUNY, now I'm asking --
11                  MR. KULWICKI:  No, you asked
12        him about --
13                  MS. CARULAS:  -- about Sinai.
14                  MR. KULWICKI:  Go ahead.
15                  You did ask him about --
16        A    I probably knew at some point then in
17   discussions and when he presented his lecture to us
18   about what he does, but I don't recall off the top of
19   my head which one it was.
20        Q    All right.
21        A    But I did know at one point.
22        Q    Okay.
23             And would it surprise you that doctors from
24   Sinai in 2010 published that the majority of cases of
25   anticoagulation for atrial fibrillation ablation was
0121
 1   to discontinue the Coumadin, not have a therapeutic
 2   INR and bridge with Heparin?
 3                  MR. KULWICKI:  Objection.
 4                  You can answer.
 5        A    Do I know that they wrote about that?  Was
 6   that your question?
 7        Q    My question was, would that surprise you if
 8   they did?
 9        A    Would it surprise me?  I don't know.  It
10   depends, I have to look at it in context.
11        Q    Were you aware that they had published that?
12        A    No.
13        Q    And again, you wouldn't be aware because
14   that's not literature you keep up on?
15        A    Right.
16        Q    How do you explain, if it is as Dr. Levine
17   says, known that the stroke risk is higher if you
18   bridge with Heparin than if patients are on continuous
19   Coumadin, okay, if that is known, how do you explain
20   that cardiologists, hypothetically, are still using
21   the bridging with Heparin?
22        A    I don't know.  I mean, I don't know that
23   people have been randomized.
24        Q    Okay.
25        A    I mean, the only way to really know is if
0122
 1   people were being randomized.  And that's the whole
 2   issue about whether this is research or not to try to
 3   get at those numbers through research or through just
 4   looking retrospectively at their data or prospectively
 5   at their data as part of the protocol or not or
 6   what -- you know, what's this about?
 7        Q    Okay.
 8        A    But we know that regardless of how you do
 9   the procedure, right, the procedure still carries
10   stroke risk.
11        Q    Sure.
12        A    And the stroke -- the longer the INR is
13   subtherapeutic the greater the risk because it's
14   cumulative over time based on the INR.  And the INR is
15   a logarithmic function so that the lower the INR, the
16   logarithmic increase in stroke risk.
17        Q    Okay.
18             And when you say, we know that, this is
19   literature talking about A-Fib in general?
20        A    Correct.
21        Q    Okay.
22        A    Right.
23        Q    All right.   So your --
24        A    But it's applicable to the period of time
25   pre, post and during ablation treatments as to the
0123
 1   risk of stroke being weighed in at.  Well how long has
 2   the INR been low?  And how long -- and how low is it,
 3   right?  The risk at one four is much getter risk of
 4   stroke than at 1.9.
 5        Q    Okay.   But I just want to understand where
 6   Dr. Levine comes with his opinion.
 7        A    All right.
 8        Q    And it's from the A-Fib literature in
 9   general, not the ablation literature per se?
10        A    Well, I don't know.  I think that there is
11   some ablation literature that says that the stroke
12   risk maybe higher when you don't protect, and I think
13   the Cleveland Clinic published some of that data.
14        Q    Okay.  And my question to you is:
15             While it maybe higher, to this day do you
16   know whether or not there has been any proof that
17   indeed the risk of stroke is more likely than not
18   increased when patient are bridged versus patients who
19   are on continue Coumadin with a therapeutic INR?
20        A    Well, proof is an interesting word in
21   medicine.
22                  MR. KULWICKI:  Just let me
23        object.
24                  Go ahead, please.
25        A    At what level of certainty do you accept
0124
 1   proof?  Does it have to be, you know, Grade A data
 2   that is randomized, double-blind placebo controlled
 3   studies?  Or is it just Grade 2 with just comparative
 4   studies, epidemiology?  I mean, what level are we
 5   satisfied at?
 6             There's a lot of things that we know are not
 7   right that clearly increase people's risk and yet we
 8   do them all the time, though I try to avoid it and --
 9   such as stopping anticoagulation for a colonoscopy.
10   People do it for a week sometimes beforehand or
11   sometimes two weeks, and then they don't even restart
12   it for a week or two and somehow that patient's got up
13   to potentially a month of unprotected A-Fib with not
14   anticoagulated for an elective procedure then maybe
15   the better -- we know that the risk -- no, again
16   proof.  It makes sense just because of the general
17   concept that we know that the lower the INR for the
18   longer period of time the greater the stroke risk.
19   That if you apply that to elective procedures or
20   atrial fibrillation ablation that those patients are
21   at higher risk.
22             So I can bring someone in potentially on
23   Heparin and bridge them and then start the Coumadin,
24   maybe that would lower their risk.  It makes sense.
25   Now, do we have proof of that?  No.  I don't think
0125
 1   there's been randomized studies of that.  But, again,
 2   it's what level of proof?
 3             I mean, we don't have to now randomize
 4   people to -- with acute abdomen to do an appendix
 5   removal or antibiotics or watch it, you know.  We all
 6   sort of practice that way, so maybe that's where we
 7   are with it.
 8             Again, I'm not a cardiologist, so is what
 9   cardiologists are writing about and stating, is it
10   just because that's sort of what the consensus is and
11   that's what it is or is there really good data one way
12   or the other to answer?  Again, I'm not in a position
13   to give you an answer on that.
14        Q    Okay.
15             Do you know whether there has been any
16   consensus statement written in the electrophysiology
17   world that the stroke risk is indeed higher, more
18   likely than not, when the Heparin bridging is used
19   versus the continuous Coumadin therapeutic INR route?
20        A    I don't know.  I would have to look at -- do
21   a literature search or see if there's something
22   written about that.  I don't know.
23        Q    You've looked at the guideline that Mr.
24   Kulwicki has provided you, correct?
25        A    Right.  I don't recall off the top of my
0126
 1   head about that specifically.   I mean, we can go back
 2   if you think -- if you're referring to something
 3   specific in one of the exhibits, then let's look at it
 4   together.  I don't recall off the top of my head.
 5        Q    Sir, in the interest of time, I need to know
 6   what your basis is for giving an opinion in this case,
 7   and is it grounded at all on any of the guidelines.
 8             As you sit here today you're not aware of
 9   any guidelines that specifically say that?
10        A    Right.  I mean, my opinions are based on
11   that he had a procedure that increased his risk of
12   stroke in conjunction with a low INR that increases
13   his risk of stroke.
14        Q    Okay.
15        A    And then the other issues that we've,
16   obviously, grappled with.
17        Q    All right.
18             Now, are you aware whether or not there have
19   ever been reported cases of strokes in patients
20   undergoing atrial fibrillation ablation who have
21   therapeutic INR?
22        A    Yeah.  I would think that that --
23                  MR. KULWICKI:  Objection.
24        A    I'm sure there are.  Just like there are
25   people that have strokes without atrial ablation
0127
 1   procedures with A-Fib on Coumadin who have a
 2   therapeutic INR.  It reduces the risk, it doesn't
 3   eliminate it.
 4        Q    And when you say, it reduces the risk, are
 5   you able to quantify number-wise --
 6        A    Yeah, sure.
 7        Q    Let me finish.
 8        A    Oh, I'm sorry.
 9        Q    Let me start again.
10             Are you able to say to a reasonable degree
11   of medical probability that had Mr. Sullivan been
12   placed in the continuous Coumadin arm with a
13   therapeutic INR and had this procedure that he would
14   not have a stroke?
15        A    Including the pre-procedural reduction to
16   whatever it was, 1.4 before?  I mean, for the whatever
17   length of time he was subtherapeutic prior to the
18   procedure.
19             I'm not talking -- are you just talking
20   about just the procedure in a vacuum or are you
21   talking about generically his whole treatment
22   algorithm of when, if he had a doze that he was on
23   reduced and he was subtherapeutic prior to the
24   procedure?  Or are you talking about just the period
25   of a couple of hours of the procedure?  I guess I'm
0128
 1   not clear on where -- what you're driving at.
 2        Q    All right.   You've --
 3        A    Because I'll give you -- I mean, the bigger
 4   answer --
 5        Q    Yes.
 6        A    -- over the whole period of time is we have
 7   very good data that's quantifiable that Coumadin
 8   reduces the risk of stroke in A-Fib by between 62 and
 9   66 percent.  So roughly two out of three strokes are
10   prevented with anticoagulation -- with Coumadin in
11   people with A-Fib.
12        Q    Okay.
13        A    And then it goes down from there, which is
14   certainly more likely than not, sixty-some-odd percent
15   is more likely than not.  And then depending on the
16   INR it goes down.  If you drop the INR then --
17        Q    Okay.
18        A    -- protection of Coumadin reduces.
19             So the question is over what period of time?
20   Are we talking about just, you know, a couple of hours
21   or are we talking about all of the times that he
22   was --
23        Q    Right.
24        A    -- subtherapeutic?
25        Q    And I think you've answered this, but when
0129
 1   you're talking about the 62 to 66 percent risk that's
 2   in A-Fib population not undergoing ablation?
 3        A    Right.  Just in general, right.
 4        Q    Okay.
 5        A    Because there was a period of time that he
 6   was made subtherapeutic in preparation for the
 7   ablation, that counts.
 8        Q    Right.
 9        A    Because he -- if he's subtherapeutic before
10   the ablation then he could be forming clot in his left
11   atrium even though, you know, if he has a CTA it
12   doesn't necessarily mean it picks up every little
13   clot.  And certainly he could have formed a clot post
14   CTA and when they punctured the septal wall
15   potentially, whenever.  But the point is that the
16   longer you're off the -- or subtherapeutic on the
17   Coumadin the greater the risk of forming clot and
18   having stroke.
19        Q    All right.
20        A    Whether or not -- yeah.  And includes the
21   time in A-Fib before the ablation as well as the
22   intraprocedural time.
23        Q    All right.
24             You understand the whole concept of doing a
25   TEE or a -- you said a different procedure.
0130
 1        A    CTA.  Well, I think that's what was done at
 2   the Cleveland Clinic, right?  They did a contrast CT
 3   of his left atrial appendage or left atrium.
 4        Q    Okay.
 5             You understand the concept of in what
 6   circumstances electrophysiologists do either a TEE or
 7   ACT scan to look for a right atrial clot -- right
 8   atrium clot?
 9        A    Right or left?
10        Q    Left, I'm sorry.  Left atrium clot, right?
11        A    Yeah.  I mean, depending on -- again, I
12   don't know what the local standard or custom is.  Some
13   institutions might use CT, some might use MR, some
14   might use echo, ultrasound, TEE, I don't have my
15   finger on that pulse of what different --
16        Q    Okay.
17             And you understand that the practice is to
18   do a procedure like that if a patient is found to have
19   a subtherapeutic INR; are you aware of that?
20        A    I mean, there may be other reasons too.  I
21   mean, there's protocols for when to do them, and that
22   maybe one indication for when to do them.
23        Q    You're not familiar with what the protocols
24   are, per se?
25        A    Not in detail, I don't think I could list
0131
 1   every reason, but that's certainly one reason.
 2        Q    All right.  So let's go back to my question.
 3             We've talked about before that you know
 4   there are patients who have suffered strokes despite
 5   being on continuous Coumadin with a therapeutic INR?
 6        A    Sure.
 7        Q    But have undergone an atrial fibrillation?
 8        A    Well again, we have to be careful.   We
 9   assume that they're therapeutic INRs, but you have to
10   go back because in general practice only about two out
11   of three INRs in the best of hands are therapeutic.
12   So it's naive to think over years and years and years
13   that every single INR will necessarily be therapeutic.
14        Q    Right.
15        A    But, you know, an experienced cardiologist,
16   in their best hands, often it's about two out of three
17   INRs will be in range, some higher, some lower.
18        Q    Okay.
19             So given the fact that we know, even in
20   those where the hope is to get them in a therapeutic
21   INR and keep them on continuous Coumadin or there's
22   the group where the decision was made, we're going to
23   take you off the Coumadin.
24        A    Okay.
25        Q    And bridge you with Heparin.
0132
 1        A    Okay.
 2        Q    Right.   And you probably don't know the
 3   statistics as far as how many do one arm versus the
 4   other?
 5        A    How many cardiologists around the country
 6   you mean?
 7        Q    Right.
 8        A    I have no idea.
 9        Q    Okay.
10             Do you know of those who have undergone
11   atrial fibrillation ablation that do not have a
12   therapeutic INR and undergo the procedure, what
13   percentage of those patients end up having strokes?
14                  MR. KULWICKI:  Can you read
15        the question back?  I'm sorry, it was
16        just convoluted.  Please.
17                  (WHEREUPON, the requested
18        question was read back by the court
19        reporter.)
20                  MR. KULWICKI:  Okay.
21        A    From the procedure in the periprocedural
22   period or subsequently for months or years after?  I
23   mean, what's the -- what are you driving at?
24        Q    Any of the above.  Do you know what the
25   statistics are?
0133
 1        A    Any of them?
 2        Q    Yes.
 3        A    I think it's quoted somewhere 1 to 5, 6, 7
 4   percent risk of stroke with the procedures if they're
 5   not anticoagulated adequately depending on the study
 6   or whatever, and depending on how far out you go, you
 7   mean, it maybe end up longer.  Depends on whether they
 8   -- it works or doesn't work.
 9             Obviously, if the ablation doesn't work and
10   they go back into A-Fib, then they're risks are going
11   to probably be higher than if they aren't in A-Fib.
12   So there's a lot of potential variables.
13        Q    The 1 to 7 percent that you to me is
14   something that you've obtained from the EP literature?
15        A    Right.
16        Q    As opposed to your own knowledge as a stroke
17   neurologist?
18        A    Right.  I mean, just because sometimes the
19   literature looks at things more in depth than just my
20   own experience or whatever, I mean...
21        Q    Right.
22             Have you personally had any patients that
23   have undergone an atrial fibrillation ablation and
24   have had a stroke?
25                  MR. KULWICKI:  Objection.
0134
 1                  You can answer.
 2        A    During the procedure or subsequent to the
 3   procedure or -- I mean, that's a very broad question,
 4   so how do you mean it?
 5        Q    I want to know your experience.
 6             Do you have any patients that you personally
 7   have managed or seen or have any experience with that
 8   have undergone this procedure, the ablation and have
 9   suffered a stroke?
10                  MR. KULWICKI:  Objection.
11        A    Yeah, yeah.
12                  MR. KULWICKI:  You can
13        answer.
14        A    I think so.  I think one or two at Sinai.
15        Q    And do you know what the mode of
16   anticoagulation was in those one to two patients?
17        A    I don't recall.  I can't answer that.
18        Q    Do you know who the electrophysiologist was
19   that performed the procedure?
20        A    Multiple choice, not fill in the blank.  I
21   don't recall off the top of my head, but I would
22   recognize it if given a list.
23        Q    And did they suffer a minor stroke, major
24   stroke?
25        A    I don't recall.  One may have been mild to
0135
 1   moderate.   I don't recall what the other one was.
 2        Q    I mean, as you sit here today, do you have a
 3   specific recollection of these patients or are you
 4   just hypothesizing that you think you may have?
 5        A    I'm not -- hypothesis is like, you know,
 6   unproven and just stating something that you think.
 7   No, I have recollection of those cases.  I think they
 8   were seen by the stroke consult service and, you know,
 9   but I don't recall how bad the strokes were or what
10   the anticoagulation route was or...
11        Q    Right.
12             Besides this one or two patients at Mount
13   Sinai, have you had experience with any other patients
14   who have undergone an atrial fibrillation ablation?
15        A    Well, I have one patient of mine that's
16   considering having it done, but I don't know that he's
17   had it done yet.   I mean, he's weighing the risks and
18   benefits.
19        Q    Besides the one or two patients at Mount
20   Sinai, do you have any experience with any other
21   patients that have undergone an atrial fibrillation
22   ablation?
23        A    Personal experience?   Not that I can recall
24   off the top of my head.   I mean, I have probably seen
25   patients that have probably had it undergone, you
0136
 1   know, have undergone it, but I don't know how many
 2   they are.
 3        Q    So back to my question --
 4             You need to --
 5        A    I just want to take it real quick.
 6                  (WHEREUPON, there was a brief
 7        interruption.)
 8        Q    Back to my question, since you're aware of
 9   patients who have had or at least you know from -- not
10   personal experience, but based on your understanding
11   of the literature that patients who have the
12   continuous Coumadin and therapeutic INR have undergone
13   this procedure and suffered stroke.
14        A    Well, that wasn't -- that 1 to 7 percent was
15   for, I thought, people who weren't.  Was it for people
16   who were, is that what you're saying?
17        Q    Do you know?
18        A    I mean, these numbers are just so small to
19   make any kind of meaningful estimates so it's hard to
20   know.
21        Q    Hard to know what?
22        A    It's hard to know if there's significant
23   differences between the two as it relates to stroke
24   risk, the numbers are very small.
25        Q    And just for the record --
0137
 1        A    I'm trying to find --
 2        Q    Yes.  I'm sorry.
 3             When you were looking at the first article
 4   is exhibit, what were you looking at, exhibit?
 5        A    C.
 6        Q    Exhibit C, okay.
 7             And have you looked at any others right now
 8   as we're talking?
 9        A    (Witness perusing documents.)
10        Q    I'm sorry, as you're going you through, tell
11   me what you're looking at.
12        A    F.
13        Q    Okay.
14        A    So it says here:
15                  Catheter ablation of atrial
16        fibrillation is associated with potential risk of
17        periprocedural stroke which can range between 1
18        and 5 percent.
19             It says that:
20                  A combination of open irrigation
21        ablation catheter in periprocedural therapeutic
22        anticoagulation with Warfarin may reduce the
23        risk of periprocedural stroke without increasing
24        the risk of pericardial affusion or other
25        bleeding.
0138
 1             And that's what they.   So that's the best
 2   data that I think we have.  That's from Circulation
 3   2010 even though it's not randomized.
 4        Q    Okay.  And that's Exhibit F, and that's from
 5   the folks of the Cleveland Clinic, correct?
 6        A    Right.  Burkhardt is the second author on
 7   there.
 8        Q    So based on what you have seen in the
 9   medical literature, as of today, let alone 2006, do
10   you see any evidence where it has been established
11   that more likely than not stroke is indeed reduced by
12   the arm of continuous Coumadin with a therapeutic INR
13   versus the Heparin bridging?
14                  MR. KULWICKI:  Objection.
15                  You can answer.
16        A    I mean, this paper from 2010 suggests that
17   it is.   Whether you want to -- how we interpret that
18   is convincing or whatever words you use to describe
19   it.  I mean, that's just what it says there.
20        Q    Okay.
21        A    In terms of more likely than not, I mean,
22   you know, that's hard for a rare event.
23        Q    Okay.
24             And you would understand that while
25   something may be possible that does not make it
0139
 1   necessarily probable, more likely than not?
 2        A    Sure.
 3        Q    I know we're getting close, but maybe we can
 4   finish up if we keep pushing or do you need to leave?
 5        A    We will call three the latest.
 6        Q    Okay.
 7             The best way for one to determine if indeed
 8   there is proof one way or the other to make the
 9   statement more likely than not is if there is, as you
10   mentioned earlier, a randomized, controlled study
11   where patients are, in fact, placed in a research
12   study where one is in one arm and the other is in the
13   other arm?
14        A    That's the gold --
15                  MR. KULWICKI:  Objection.
16        A    That's the gold standard, doesn't mean you
17   have to have that for everything we do because there's
18   a lot of things we do that don't have that, but that's
19   would be the gold.
20        Q    Okay.
21        A    Excuse me one second.
22        Q    Sure.
23                  (WHEREUPON, there was a brief
24        interruption.)
25                  THE WITNESS:  Sorry.
0140
 1        Q    Do you know whether or not there is
 2   currently a study underway enrolling patients to look
 3   at this exact issue?
 4        A    Maybe, I don't know.
 5        Q    You don't know?
 6        A    I don't know.
 7        Q    And if there was, of what significance would
 8   that be for you?
 9        A    That we still don't know the best way to do
10   it.  That's it's ethical to do it either way.  And
11   that if there were alternatives at the time of Mr.
12   Sullivan to do it or not do it and one might have been
13   safer or not, but there was arbitrary decisions as to
14   which group he was in, then was he apprised of those
15   options, and was he truly given informed consent about
16   his choices at that time.  And was it research?
17             Again, goes back to the same issues is that
18   they collecting data to publish this paper, and people
19   like him, before and after him were included in the
20   stroke count, but we can't find him in there, what's
21   the --  again, what's going on.
22        Q    Okay.
23             Do you know whether or not Dr. Burkhardt had
24   any discussion with Mr. Sullivan about the status of
25   his INR and how his anticoagulation would be handled
0141
 1   during the procedure?
 2        A    I don't recall that.
 3        Q    What you're essentially saying here is,
 4   number one, if it was research, if he was put into a
 5   research arm for this publication, then you think he
 6   should have been told that and given a signed form,
 7   correct?
 8                  MR. KULWICKI:  Objection.
 9                  You can answer.
10                  That's not what he said, but
11        go on.
12        Q    You disagree with that?
13        A    (No response.)
14                  MS. CARULAS:  Would you read
15        the question again so I can make sure
16        we're all...
17                  WHEREUPON, the requested
18        questions was read back by the
19        court reporter.)
20        Q    You do you agree with that?
21        A    Well, I --
22                  MR. KULWICKI:  I object.
23                  You're saying it's limited to
24        this publication, that's my objection.
25        I mean, I don't think that's
0142
 1        appropriate.
 2        A    Right, generically?
 3        Q    Yes.
 4        A    If he was having things done to him.
 5        Q    Yes.
 6        A    That were unproven or experimental or not
 7   within standard of care as clinically proven or
 8   efficacious then he needed to be informed of what his
 9   choices were and what the risks and benefits are in a
10   written way.  Especially if the Cleveland Clinic is
11   known to, which they are, to want to write this up,
12   and this is their research, and this is their
13   experience, and this is what they're finding.  And
14   they know that, you know, there are different ways to
15   do things.  You know, why wasn't he put in the other
16   arm?  Why wasn't he put in the therapeutic arm if
17   there was -- in the nonstop -- you know, continuing
18   the Coumadin if they were doing that?  I mean, what
19   decisions went into that is what I don't know.
20        Q    Okay.
21        A    Maybe they thought he was well risk because
22   his CHADS2 score was low, it was zero, but if he was
23   higher maybe -- again, I don't know, but maybe he
24   would have been given more anticoagulation had he been
25   higher score.  I don't know.
0143
 1        Q    The fact that he did have the CHADS2 of zero,
 2   looking prospectively it would make him lower risk,
 3   you would think --
 4        A    Low risk, but I don't know that the's
 5   necessarily lower risk from the procedure.  He's lower
 6   risk from the A-Fib.
 7        Q    Okay.
 8        A    He maybe at the same or higher risk from the
 9   procedure, we don't know that.
10        Q    You don't know one way or the other?
11        A    I don't know that we know.   I don't know
12   that I seen anything where we know that the CHADS2
13   score may predict risk from the procedure as opposed
14   to from the A-Fib.
15        Q    Okay.
16             Do you have any knowledge as to what the
17   success rate of this procedure is?
18        A    Well, again, this procedure is heterogenial,
19   there is multiple aspects to the procedure.  So if
20   you're talking about the blanket global, generic term
21   of atrial ablation then I think it's variable.  I've
22   seen numbers as low as 50, 60 percent up to numbers --
23   I think I heard of, you know, 70, 80 percent, so it
24   was a range.  And then if you start getting into, you
25   know, the robot or this catheter or this or that
0144
 1   aspect, you know, then maybe it changes.
 2        Q    All right.
 3        A    Maze, no maze, you know, where in the
 4   pulmonary?  How many sampling areas in the pulmonary
 5   vein or the atrium?  There's lots of different
 6   variables.  So I can't answer generically, it's just
 7   procedures -- then the range is better.
 8        Q    And again, I know you don't give an informed
 9   consent discussion on this procedure --
10        A    Right.
11        Q    -- for patients, but that is as to one
12   individual patient what their risks and benefits are,
13   and what the anticipated success rate is, that's
14   something that should come directly from the
15   electrophysiologist who's having the discussion with
16   the patient?
17        A    Right.
18                  MR. KULWICKI:  Objection.
19                  You can answer.
20        A    Right.
21        Q    But as a general statement, if one were
22   talking globally --
23        A    Right.
24        Q    -- about this procedure -- again, I know
25   you're not an electrophysiologist, but you would have
0145
 1   no criticism of the global statement that:
 2                  Catheter ablation is safe and effective
 3        and is successful in more than 90 percent of the
 4        cases.
 5        A    I might.
 6                  MR. KULWICKI:  Objection.
 7        A    Sure.  I think that's overestimating.   I
 8   don't know.  Again, I'm not a -- again, like you said,
 9   I'm not an electrophysiologist, but that sounds awful
10   high to me.
11        Q    Okay.
12             Have you looked at all at the Stony Brook
13   University Medical Center website as far as what they
14   say is -- a general statement as far as the catheter
15   ablation --
16        A    No, I don't know that they said that.
17        Q    Those who put this together would be in a
18   better position, obviously, than you to comment on
19   that?
20                  MR. KULWICKI:  Objection.
21        A    Again, you got to be careful because that's
22   not necessarily science on the internet, right?  That
23   could be marketing, and people sometimes spin
24   marketing or take things out of context.  And if
25   marketers are looking at data, maybe they don't take
0146
 1   the broad context or they just look at one study, who
 2   knows?  But it's unlikely -- I don't know that that's
 3   written by cardiologists as opposed to people with a
 4   degree in marketing.  So, I don't know.
 5        Q    Okay.
 6        A    Sounds high.
 7        Q    All right.
 8        A    And I know my dad wasn't quoted those
 9   numbers when he went and had it evaluated with his
10   cardiologist.
11        Q    Okay.
12             And besides sitting in with your dad's
13   cardiologist, do you have any other experience with
14   what electro --
15             Is your dad's cardiologist
16   electrophysiologist or a cardiologist?
17        A    No, cardiologist.   No, I heard --
18                  MR. KULWICKI:  Objection;
19        asked and answered.
20                  Go ahead.
21        A    I heard the data from our
22   electrophysiologist at Sinai when I was there.  She
23   gave us all that data.
24        Q    What, the multiple choice, the option --
25        A    Yeah, yeah.
0147
 1        Q    Okay.   All right.
 2             Do you know --
 3        A    I'm trying to remember his name, but you can
 4   get it -- you can get it off -- I can get it off the
 5   website.
 6        Q    Do you know what the statistics were that he
 7   used?
 8        A    I can't recall exactly, but they certainly
 9   weren't over 90 percent.
10        Q    Okay.  I'm just -- I don't want you to --
11        A    No, but I'm just saying I don't know if
12   that's -- you know, who wrote that.  Is there a
13   reference for it?  I mean, that's the thing, you know,
14   how credible is it?
15        Q    Okay.
16             At the time of trial will you be giving an
17   opinion as to what the success rate is for this
18   particular procedure?
19        A    No.
20        Q    Tell me if you would agree with this
21   statement or not.
22                  At present the optimal anticoagulation
23        management that minimizes thromboembolism while
24        not increasing hemorrhagic complications is not
25        well established.   Discontinuation of Warfarin
0148
 1        three to five days before ablation, use of
 2        Heparin or Enoxaparin before the procedure and
 3        bridging with low molecular weight Heparin with
 4        Warfarin after ablation is the most preferred
 5        used -- is the most frequently used protocol.
 6                  MR. KULWICKI:  Objection.
 7                  You can answer it.
 8        A    Well, I mean, if that's most frequently is
 9   based on some survey of, you know, thousands of
10   cardiologists around the world or the country, then
11   maybe that's what they're saying.  I don't know.
12             Again, you know, whether I agree with it or
13   not you can always say that we don't know what the
14   best is because now there's two new drugs to treat
15   atrial fibrillation that have been -- you know, one's
16   approved, one's pending approval.  So, you know, I
17   don't know.  I don't think we know what the optimum
18   is.
19             But the issue is when you don't know what it
20   is and there are choices, that's when you got to talk
21   to patients about the different choices they have.
22        Q    Okay.
23             And you don't know what was discussed
24   between Dr. Burkhardt and Mr. Sullivan as far as the
25   level of his INR, going for a CT scan or any of that?
0149
 1                  MR. KULWICKI:  Objection.
 2                  What do you mean?  Has he
 3        read it in his deposition or was he
 4        there?  I mean, what do you mean does
 5        he know?
 6        Q    Can you answer the question?
 7        A    Well, I've read his deposition.  I mean, I
 8   see what's documented in the chart.  It's not clear
 9   that Dr. Burkhardt documented a lot of risks,
10   benefits, et cetera.  There might have been an
11   anesthesiologist, there might have been a nurse, I
12   mean, I don't know what actually went on there.
13        Q    Okay.
14        A    And again, I don't have any informed consent
15   to tell me that things were specified about what his
16   choices were.
17        Q    Tell me if you would agree with this.  This
18   was written in 2009:
19                  Currently relatively few centers
20        performed catheter ablation of atrial
21        fibrillation under a therapeutic INR, whereas
22        some groups even advocate no Warfarin before and
23        after AF ablation in patients with paroxysmal
24        A-Fib and CHADS2 score of less than two.  Most
25        centers worldwide perform catheter ablation of
0150
 1        atrial fibrillation according to consensus
 2        document of 2007 with bridging of patients with
 3        Heparin.   We await the next consensus document.
 4                  MR. KULWICKI:  Objection.
 5                  You can answer it.
 6        A    So do I agree with that?
 7        Q    Yes, or have any reason to disagree with it?
 8        A    I don't have any reason to necessarily
 9   disagree with it.   Again, it comes down to what were
10   the treatments options and what was he told, and what
11   was he given choices for?
12        Q    And that's really the gist of your
13   bottom-line opinion here?
14        A    Other than what I think caused his stroke,
15   yeah.
16        Q    Okay.
17             And the basis for saying the cause of his
18   stroke was choosing the bridging arm with Heparin
19   versus the continuous Coumadin arm with a therapeutic
20   INR is, number one, the general atrial fibrillation
21   literature and the statistics there on being on a
22   therapeutic INR, correct?
23        A    Right.  And the fact that he was lowered off
24   the INR.  The fact that he was cardioverted which is
25   an increased for stroke when you cardiovert somebody
0151
 1   from atrial fibrillation.   I mean, there's a lot of
 2   things.
 3             Right, the longer you go unprotected before,
 4   during and after a procedure, the greater the risk,
 5   and that's regardless of whether the procedure is
 6   ablation or not.  But ablation in and of itself is a
 7   procedure that increases stroke risk.  So it's not
 8   colonoscopy where there's no reason to believe a
 9   colonoscopy increases your stroke risk.  But if you
10   have to come off your Coumadin to have the colonoscopy
11   then you're stroke risk goes up.
12             Here's a case where your stroke risk goes up
13   whether you're on Coumadin or not just by having the
14   procedure, and then by being on a lower therapeutic
15   INR presumably that's additive or multiplicative to
16   the risk.
17        Q    Okay.  Now --
18        A    Do you have --
19        Q    Yeah, I'm almost done.
20        A    What do you have, five minutes?
21        Q    Yes.
22             You said you don't know that the Stony Brook
23   University website actually says to patient, You may
24   be asked to stop taking your anticlotting medication
25   prior to this procedure.  You weren't aware that that
0152
 1   was on their website?
 2        A    No, I don't know what's --
 3                  MR. KULWICKI:  Objection.
 4        A    I don't know what's on their website about
 5   this stuff.
 6        Q    Okay.
 7             Have you ever gone to tell any of the
 8   electrophysiologists at Stony Brook --
 9        A    I'm not at Stony Brook.
10        Q    What's that?
11        A    I'm not at Stony Brook.
12        Q    Okay.
13             Stony Brook is part of the hospital system.
14        A    It's part of the state university.  It would
15   be like somebody at UCLA telling somebody at UCSD what
16   to do or what they should be doing.
17        Q    Okay.
18             Have we covered all of your opinions, do you
19   believe?
20        A    I don't know, it's up to the attorney what
21   my opinions are -- what areas he wants me to talk
22   about.
23                  THE WITNESS:  Have we covered
24        it?
25                  MR. KULWICKI:  Well, it's not
0153
 1        my deposition.
 2                  THE WITNESS:  Oh.
 3        Q    Yeah, I need to know --
 4        A    Yeah.  I don't have any other opinions.  I
 5   think they've come out over and over again during
 6   this.
 7        Q    Okay.
 8             If you develop any new opinions that are not
 9   in your report or that you have not articulated here
10   today, would you please let Mr. Kulwicki know that so
11   I'm apprised of that before you testify?
12        A    Yeah.  If something comes up with new
13   information then I might change my opinion.  We'll see
14   if there's new evidence.
15        Q    Okay.
16             And then we have your list here of things.
17                  MS. CARULAS:  Just so you
18        know, Dave, I'll send you a letter too.
19        Q    But I'd like all your corresponding letters,
20   the list of your deposes, the billing record and your
21   fee schedule.
22        A    So once I get an e-mail listing it all, then
23   I'll take care of it.  I'm not going to remember it
24   all right now, but okay.
25        Q    Okay.   Thank you.
0154
 1        A    Good.
 2                  MR. KULWICKI:  Well, before
 3        we go off the record, I just want to
 4        clarify one point because I don't want
 5        to have to come back and get an
 6        affidavit for me clarifying.
 7                  THE WITNESS:  Okay.
 8   EXAMINATION BY
 9   MR. KULWICKI:
10        Q    Doctor, with respect to your position with
11   regard to clinical research, is that clinical research
12   intertwined with patient-care activities?
13        A    Yeah, almost my definition.  Clinical
14   research means it has to do with patients.
15        Q    Okay.
16                  MR. KULWICKI:  That's all I
17        have.
18                  And we'll read, if that makes
19        sense to you.  Under Ohio law we have
20        the right to review the transcript and
21        make changes if there are errors in
22        transcription, okay.
23                  And we could make
24        arrangements.
25                  THE WITNESS:  Thank you.
0155
 1                  (WHEREUPON, this deposition
 2        concluded at 3:07 p.m.)
 3   
 4   
 5                       _______________________________
 6                          STEVEN RICHARD LEVINE, M.D.
 7   
 8   
 9   Subscribed and sworn to before me
10   this         day of         2011.
11   ___________________________________
12             NOTARY PUBLIC
13   
14   
15   
16   
17   
18                       *      *      *
19   
20   
21   
22   
23   
24   
25   
0156
 1                            I N D E X
 2     WITNESS                       EXAMINATION BY      PAGE
 3     Steven Richard Levine, M.D.   Ms. Carulas           3
 4                                   Mr. Kulwicki        154
 5                          *      *      *
 6                         E X H I B I T S
 7     LEVINE                   DESCRIPTION              PAGE
 8       A                 A Kanj Article from 2007,      26
                           Pulmonary Vein Antrum
 9                         Isolation
10       B                 An Article by Di Biase         26
                           entitled Remote Magnetic
11                         Navigation, 2007
12       C                 The 2007 article where         27
                           Wazni is the lead of the
13                         article, Atrial
                           Fibrillation Ablation
14                         In Patients With
                           Therapeutic INR
15   
         D                 The Heart Rhythm Society,      28
16                         et cetera, Expert Consensus
                           Statement on Catheter and
17                         Surgical Ablation where
                           Dr. Calkins is the lead
18                         Author
19        E                A second copy, a repeat        28
                           of a prior exhibit
20   
          F                An article where Di Biase      29
21                         is the lead author of a
                           2010 article in circulation
22                         entitled Periprocedural
                           Stroke
23   
24   (CONTINUED)
25   
0157
 1        G                An article entitled            31
                           Atrial Fibrillation
 2                         Ablation Without
                           Interruption of
 3                         Anticoagulation; the
                           lead author is
 4                         Santangeli
 5        H                A repeat of Dr. Di Biase       32
                           circulation
 6   
          I                Another copy of the            32
 7                         Santangeli article
 8        J                A third copy of the            33
                           Di Biase article in
 9                         circulation
10        K                Another copy of Dr.            34
                           Wazni's article
11   
          L                An article where Dr.           34
12                         Patel is the lead author,
                           Long-Term Functional and
13                         Neurocognitive Recovery
14        M                The ACC/AHA/ESC 2006           35
                           Guidelines
15   
          N                The same thing as              35
16                         Exhibit M but thicker
17        O                Another copy of the            35
                           Heart Rhythm Society
18                         2007 Expert Consensus
19      P & Q              Dr. Chabon's Report            42
                           and Dr. Moreno's Report
20               (All exhibits attached to transcript)
21   
22   
23   
24   
25   
0158
 1                            I N D E X
 2                    REQUESTS FOR INFORMATION
                   AND/OR PRODUCTION OF DOCUMENTS
 3   
       DESCRIPTION                                       PAGE
 4   
       Produce a copy of your transmittal letters          9
 5   
       Produce a list of all cases Dr. Levine has         54
 6     worked on
       Produce the billing record                         54
 7   
 8   
 9   
10   
11   
12   
13   
14   
15   
16   
17   
18   
19   
20   
21   
22   
23   
24   
25   
0159
 1                         C E  R T I F I C A T E
 2   
 3     STATE OF NEW YORK    )
 4                          :  SS.:
 5     COUNTY OF NEW YORK   )
 6                    I, YVETTE MOSLEY, a Notary Public
 7     for and within the State of New York, do hereby
 8     certify:
 9                    That the witness whose examination is
10     hereinbefore set forth was duly sworn and that such
11     examination is a true record of the testimony given
12     by that witness.
13                    I further certify that I am not related
14     to any of the parties to this action by blood or by
15     marriage and that I am in no way interested in the
16     outcome of this matter.
17                    IN WITNESS WHEREOF, I have hereunto set
18     my hand this 11th day of April 2011.
19   
20   
21                        ___________________________________
22                                   YVETTE MOSLEY
23   
24   
25