0001
 1               CUYAHOGA COUNTY, OHIO
                 COURT OF COMMON PLEAS
 2   
 3                       - - -
 4   
     SHANNON SULLIVAN, et al.,    :   CASE NO.
 5                    Plaintiff,  :   CV-09-697617
                                  :
 6                vs.             :
                                  :
 7   CLEVELAND CLINIC FOUNDATION, :
                      Defendant.  :
 8   
 9                       - - -
10                  March 17, 2011
11                       - - -
12   
13                 Oral deposition of JONATHAN D.
14   MORENO, Ph.D., taken at the offices of the
15   Center for Bioethics, University City Science
16   Center, 3401 Market Street, Suite 320,
17   Philadelphia, Pennsylvania  19104, beginning at
18   11:00 a.m., before Cheryl L. Goldfarb, a
19   Registered Professional Reporter and an
20   approved reporter of the United States District
21   Court.
22                       - - -
23   
24               
25         
0002
 1   A P P E A R A N C E S :
 2   
 3          BECKER & MISHKIND CO., L.P.A.
            BY:  DAVID A. KULWICKI, ESQUIRE
 4          1660 West Second Street
            Suite 660
 5          Cleveland, Ohio  44113
            216.241.2600
 6          dkulwicki@beckermishkind.com
            Representing the Plaintiff
 7   
 8   
            ROETZEL & ANDRESS
 9          BY:  ANNA MOORE CARULAS, ESQUIRE
            1375 East Ninth Street
10          Ninth Floor
            Cleveland, Ohio  44114
11          216.615.7401
            acarulas@ralaw.com
12          Representing the Defendant
13   
                         - - -
14   
15   
16   
17   
18   
19   
20   
21   
22   
23   
24   
25   
0003
 1                     I N D E X
 2                       - - -
 3   WITNESS:  JONATHAN D. MORENO, Ph.D.
 4   QUESTIONED BY:                            PAGE:
 5          MS. CARULAS                           5
 6          MR. KULWICKI                        140
 7                       - - -
 8                  E X H I B I T S
 9   NUMBER        DESCRIPTION         MARKED FOR ID
10   
     Exhibit A     Letter dated June 2, 2010       8
11   
     Exhibit B     Letter dated December 20,      10
12                 2010
13   Exhibit C     Letter dated January 3,        10
                   2011
14   
     Exhibit D     Copy of Ohio Revised Code      17
15                 Annotated, Section 2317.54
16   Exhibit E     Article entitled, "Remote      20
                   Magnetic Navigation,"
17                 by Di Biase
18   Exhibit F     Five-page document printed     24
                   from Cleveland Clinic Web site
19   
     Exhibit G     Report dated January 7,        32
20                 2011
21   Exhibit H     Curriculum vitae               47
22   
                         - - -
23   
24   
25   
0004
 1              DEPOSITION SUPPORT INDEX
 2   
 3   DIRECTION TO WITNESS NOT TO ANSWER
 4   Page   Line
 5   (None)
 6   
 7   
 8   REQUEST FOR PRODUCTION OF DOCUMENTS
 9   Page   Line   Description
10   (None)
11   
12   
13   STIPULATIONS
14   Page   Line
15   (Pursuant to Ohio law)
16   
17   
18   QUESTIONS MARKED
19   Page   Line
20   (None)
21   
22   
23   
24   
25   
0005
 1                        - - -
 2                 JONATHAN D. MORENO, Ph.D., after
 3         having been first duly sworn, was
 4         examined and testified as follows:
 5                       - - -
 6                 MS. CARULAS:  I would like to
 7         just go ahead and put on the record that
 8         I do object to this testimony pursuant to
 9         the motions that we have filed as to the
10         qualifications of the witness.  But I am
11         going ahead, given the judge's limited
12         ruling as far as discoverability.
13                       - - -
14                    EXAMINATION
15                       - - -
16   BY MS. CARULAS:
17         Q.       Would you please state your full
18   name for the record?
19         A.       My full name is Jonathan David
20   Moreno.
21         Q.       Sir, you have brought your
22   entire file with you --
23         A.       I have.
24         Q.       -- is that correct?
25         A.       Yes.
0006
 1         Q.       Any portion of your file that is
 2   not here?
 3         A.       No.
 4         Q.       Anything that you've received
 5   that is not in this stack?
 6         A.       There is one work product from
 7   Mr. Kulwicki, lawyer's work product, that is
 8   not in this stack.
 9         Q.       All right.  And what was that
10   lawyer's work product?
11         A.       It was a statement about the
12   principal issues in the case.
13         Q.       When did you receive this
14   statement?
15         A.       Several days ago.
16         Q.       So sometime in March of 2011?
17         A.       Yes.
18         Q.       Had you ever seen it prior to
19   that?
20         A.       Not that particular document.
21         Q.       Had you seen another what you
22   are deeming work product prior to that?
23         A.       I called it work product because
24   that was the way it was labeled on the
25   document.
0007
 1                  I have not -- there's nothing
 2   else that is not physically present here that I
 3   have -- that I have seen --
 4         Q.       All right.
 5         A.       -- from Mr. Kulwicki, other than
 6   e-mail messages that did not contain anything
 7   except arrangements about times to talk and so
 8   forth.
 9         Q.       All right.  So as far as this
10   statement that you received several days ago,
11   how many pages was that statement?
12         A.       Gosh, maybe a dozen pages,
13   something like that.
14         Q.       A dozen?
15         A.       A dozen pages, double spaced,
16   something like that.
17         Q.       Did you read it?
18         A.       I did.
19         Q.       Was there anything in that that
20   you disagreed with?
21         A.       Nothing relevant to my testimony
22   that I disagreed with.
23         Q.       Were there things in it that
24   you --
25         A.       Some things that I didn't have
0008
 1   knowledge about, medical issues that I don't
 2   pretend to present myself as a medical expert
 3   on those issues.
 4         Q.       So besides this dozen-page
 5   statement that you received -- that you read,
 6   correct?
 7         A.       Yes.
 8         Q.       -- have you received any other
 9   types of statements or summaries from
10   Mr. Kulwicki?
11         A.       Nothing that isn't present
12   before us.
13         Q.       Now, when was it that you were
14   first contacted about this case?
15         A.       Gosh, I'm just trying to
16   recollect.  Six or eight months ago, perhaps.
17                       - - -
18                  (Whereupon, Exhibit A is marked
19         for identification.)
20                       - - -
21   BY MS. CARULAS:
22         Q.       I do have some letters here that
23   you brought with you.  I've marked as
24   Exhibit A, a letter dated June 2nd, 2010 that
25   is from Mr. Kulwicki to you; is that correct?
0009
 1         A.       Yes, ma'am.
 2         Q.       Did you receive a phone call
 3   from him prior to you receiving this letter?
 4         A.       I -- if memory serves, we did
 5   talk on the phone before I received that.
 6         Q.       Do you know how it is that
 7   Mr. Kulwicki found you?
 8         A.       I don't.  Oh, well, so I believe
 9   that somebody -- a friend of Mr. Kulwicki's
10   knew my name somehow or a nurse.  But I -- I
11   can't specify.
12         Q.       Had you ever worked with
13   Mr. Kulwicki before?
14         A.       No.
15         Q.       Besides Mr. Kulwicki, have you
16   spoken with anyone else about this case?
17         A.       No.
18         Q.       There is a nurse who was working
19   on this case by the name of Michelle Mahon.
20                  Do you --
21         A.       I don't believe we -- I may be
22   mistaken.  I don't think we spoke.
23         Q.       Do you know her?
24         A.       No.
25         Q.       Or had any dealings with her
0010
 1   before?
 2         A.       No.
 3                       - - -
 4                  (Whereupon, Exhibit B is marked
 5         for identification.)
 6                       - - -
 7   BY MS. CARULAS:
 8         Q.       Then subsequent to that, I've
 9   marked as Exhibit B, a letter sent on
10   December 20th, 2010 from Mr. Kulwicki, listing
11   some items sent, correct?
12         A.       Yes, ma'am.
13                       - - -
14                  (Whereupon, Exhibit C is marked
15         for identification.)
16                       - - -
17   BY MS. CARULAS:
18         Q.       And then Exhibit C, which is a
19   letter dated January 3rd, 2011, enclosing some
20   additional materials, correct?
21         A.       Yes, ma'am.
22         Q.       And you say any e-mails back and
23   forth would have just been logistics?
24         A.       Yes, ma'am.
25         Q.       All right.  Now, looking in your
0011
 1   file, just for some house keeping purposes, it
 2   looked like the only expert report of an expert
 3   in this case that you were sent is that of
 4   Dr. Conomy.
 5         A.       That is the only expert --
 6   everything that is before you is what I
 7   received.  And I don't know how to characterize
 8   it.  If you characterize it as an expert
 9   report, that's fine with me.
10         Q.       This is a letter of a Jack
11   Conomy, who is a neurologist.
12                  You've read this report?
13         A.       Yes.
14         Q.       To your knowledge -- and I'll
15   let you go through if you see -- are you aware
16   of receiving the reports of any other experts
17   in this case?
18         A.       I'm only aware of receiving the
19   material on the table.  I've not received --
20   I'm not aware of receiving any other reports.
21         Q.       Did you the summary from
22   Mr. Kulwicki give you any indication as to who
23   were the other experts in the case?
24         A.       I don't believe they did, no.
25         Q.       Has Mr. Kulwicki told you about
0012
 1   any of the other experts in the case?
 2         A.       He mentioned that a -- one of
 3   the other experts happens also to be at the
 4   University of Pennsylvania.  But I don't know
 5   that gentleman.
 6         Q.       So besides that expert from the
 7   University of Pennsylvania, you're not familiar
 8   with who any of the other experts are in this
 9   case --
10         A.       No, ma'am.
11         Q.       -- or the substance of their
12   opinions --
13         A.       No.
14         Q.       -- fair?  All right.
15                  We have some depositions in this
16   case, and I'm just going to note here that you
17   have the deposition of Dr. Burkhardt.
18                  You've read that, I assume?
19         A.       Yes, ma'am.
20         Q.       You had it open from Pages 86
21   through 89.
22                  Any particular reason for that?
23         A.       I would have to look at the
24   pages.
25         Q.       Okay (handing).
0013
 1         A.       No, I don't think there's any --
 2   other than personal curiosity, which they're
 3   describing some of the technicalities of the
 4   procedure, there's no particular reason it was
 5   open to that page.
 6         Q.       We then have the deposition of
 7   Stacy Poe.
 8                  Did you read her testimony?
 9         A.       Yes, I did.
10         Q.       And you have a number of
11   different stickies on there.  I'm just going to
12   have it for the record, because I'm not going
13   to have it copied again, but you have stickies
14   on Pages 66, 72, 73, 75, correct?
15         A.       (Witness nodding head.)
16         Q.       I just want to make sure you're
17   agreeing.
18         A.       Yes.  I'm sorry.  I don't
19   mean -- I know that we get warned not to give
20   nods --
21         Q.       Yes, that's fine.
22         A.       -- but verbal responses.  Yes.
23         Q.       That's fine.  On 88 and 89,
24   correct?
25         A.       Yes.
0014
 1         Q.       And then on Page 104?
 2         A.       Yes.
 3         Q.       Do you know what the
 4   significance was of stickying those?
 5         A.       In all of these cases -- and
 6   there are the pink stickies as well in some of
 7   the other documents -- I was looking for help
 8   with understanding the nature of the consent
 9   process and policies in this case.
10         Q.       You have another deposition of
11   Dr. Burkhardt that was sent here, apparently.
12   And this has a couple of additional stickies on
13   it on Page 81 --
14         A.       Yes.
15         Q.       -- Line 21 and on Page 82.
16         A.       Yes.  I should say sometimes the
17   placement of those stickers does not
18   necessarily correspond to a particular line I'm
19   interested in.  I'm just reminding myself of a
20   page to look at.
21         Q.       All right.  You have
22   Mr. Sullivan's deposition.  And you have
23   stickied, with your pink sticky here, Page 57?
24         A.       Correct.
25         Q.       What was the relevance of that
0015
 1   sticky?
 2         A.       In this instance, there was
 3   discussion of what the patient consented to.
 4   And I guess that was the -- well, that was --
 5   that must have been the reason that I was
 6   interested in that passage.
 7         Q.       And you stickied in particular
 8   the portion where Mr. Sullivan said, quote, I
 9   consented to the ablation, yes; is that
10   correct?
11         A.       That's roughly where the sticker
12   is, yes.
13         Q.       I mean, the question and answer
14   above --
15         A.       Correct.  Yes.  Yes.
16         Q.       -- where it's 23 where the
17   question is, "He has documented in his record
18   that he discussed with you the risks, benefits
19   and alternatives of the procedure and you
20   consented to the procedure; is that true?"
21                  And the answer was, "I consented
22   to the ablation, yes."
23         A.       Yes.
24         Q.       Then there's a question and
25   answer where the question was, "So you agree
0016
 1   that he discussed with you the risks, benefits
 2   and alternatives and you consented to the
 3   procedure?"
 4                  And the answer was, "To the
 5   ablation, yes," correct?
 6         A.       Yes.  I was interested in the --
 7   in the way that he expressed himself in that
 8   answer.
 9         Q.       Then we have Dr. Kanj.  And you
10   stickied Page 63 at the top, correct?
11         A.       Yes.
12         Q.       And, actually, Page 75 at the
13   top, correct?
14         A.       Yes.
15         Q.       And Page 104; is that correct?
16         A.       Correct.
17         Q.       Do you believe that was all,
18   again, relative to the issue of the consenting
19   process?
20         A.       Well, that's what I was looking
21   for when I put those stickies in.  Generally,
22   unless there might have been something else.
23   But, generally, that's what I was interested
24   in.
25         Q.       And then you have Dr. Cummings'
0017
 1   deposition, and you stickied Page 42, correct?
 2         A.       Yes.
 3         Q.       And also Page 13, actually.
 4   It's backwards.
 5         A.       Yes.
 6         Q.        There is, in this document, a
 7   printed LexisNexis document as to the Ohio
 8   Revised Section 2317.54.
 9                  Were you sent this by
10   Mr. Kulwicki?
11         A.       Yes.
12                       - - -
13                  (Whereupon, Exhibit D is marked
14         for identification.)
15                       - - -
16   BY MS. CARULAS:
17         Q.       We have marked this as
18   Exhibit D.
19         A.       All right.
20         Q.       I assume prior to Mr. Kulwicki
21   sending you this, you had never reviewed or
22   been familiar with 2317.54; is that correct?
23         A.       That is correct.
24         Q.       You have here the policy and
25   procedure of the Cleveland Clinic that was in
0018
 1   existence at the time, which is a four-page
 2   document?
 3         A.       Yes.
 4         Q.       And you stickied Page 2 next to
 5   the portion that says, "Written informed
 6   consent forms signed by patients are not
 7   utilized at the Cleveland Clinic unless
 8   specifically required by law"?
 9         A.       Yes.
10         Q.       You have the deposition of
11   Dr. Natale, but there is nothing stickied, but
12   you have a dog-ear, right?
13         A.       I'm not sure the dog-ear is
14   significant.  It might be where I stopped
15   reading at one point and didn't de-dog-ear it.
16         Q.       Was there anything in
17   Dr. Natale's deposition to you that was, as you
18   sit here today, of significance?
19         A.       I will just take a moment, if I
20   may?
21         Q.       Sure.
22         A.       No.  This was a matter of
23   interest, general interest, in the procedure.
24         Q.       Then we have another copy of
25   Dr. Kanj.  We have a CV of Dr. Kanj; a CV of
0019
 1   Dr. Burkhardt.  A copy of Responses to Second
 2   Request for Admissions.
 3                  Then you have in here what looks
 4   like three different copies of an article where
 5   the lead author is Dr. Di Biase,  D-i capital
 6   B-i-a-s-e, entitled, "Remote Magnetic
 7   Navigation," correct?
 8         A.       Yes.
 9         Q.       Did you read that article?
10         A.       I read one of the copies.
11         Q.       Okay.
12         A.       I kept them all.
13         Q.       And there is some dark
14   highlighting sections on this document of what
15   was sent to you on all three copies.
16         A.       Those are not my highlights.
17         Q.       They were highlights that
18   existed before you received --
19         A.       Yes, ma'am.
20         Q.       -- received it?
21         A.       Yes.
22                  MS. CARULAS:  And I'll just mark
23         one of the copies as Exhibit E.  Okay?
24                  THE WITNESS:  Yes.
25                       - - -
0020
 1                  (Whereupon, Exhibit E is marked
 2         for identification.)
 3                       - - -
 4   BY MS. CARULAS:
 5         Q.       Then there is some additional
 6   highlighting on here in green.
 7                  Is that yours?
 8         A.       I believe that's mine.
 9         Q.       I mean, is there any
10   significance to what you highlighted or is it
11   just to help you?
12         A.       No.  Just trying to keep track
13   of names and facts.
14         Q.       And then there are some attached
15   records here.  You highlighted the section --
16         A.       Yes.
17         Q.       -- on the procedural sedation
18   record that does mention informed consent,
19   correct?
20         A.       This is the document in which
21   the -- which the physician has initialed as
22   certifying that there was informed consent.
23         Q.       Do you know whose these initials
24   were?
25         A.       I don't think I was ever able to
0021
 1   decipher those initials.  But it looks like
 2   Kanj.
 3         Q.       And did you see from his
 4   testimony that that was -- do you recall his
 5   testifying to that?
 6         A.       This was -- I don't recall him
 7   testifying to that.  But I will take it that he
 8   did.
 9         Q.       All right.  Then just for,
10   again, housekeeping purposes, you were sent a
11   copy of the Heart Rhythm Society Expert
12   Consensus paper?
13         A.       Yes.
14         Q.       Did you read it?
15         A.       That paper I believe I scanned
16   to persuade myself that I was not an expert on
17   the subject of that paper.
18         Q.       Fair enough.  So it really is of
19   no significance --
20         A.       No.
21         Q.       -- to you in this?
22                  I assume before Mr. Kulwicki
23   sending this to you, you would have never --
24         A.       That's correct.
25         Q.       -- had an opportunity to look at
0022
 1   this?
 2         A.       I never had an opportunity to
 3   look at that; that's correct.
 4         Q.       One thing I didn't give you in
 5   my guidance ahead of time.  But try, if you
 6   can, to wait -- I'll try to do the same -- wait
 7   until I finish, so we're not talking at the
 8   same time and driving her crazy.  Okay?
 9         A.       I always feel sorry for the
10   court reporter, because like many people, I
11   have a tendency to talk over the other person.
12         Q.       We also have here a paper on the
13   NaviStar ThermoCool catheter.  And this was
14   provided to you by Mr. Kulwicki as well, I
15   assume?
16         A.       Yes, it was.
17         Q.       It's a document marked from
18   Pages 30 through 63?
19         A.       Yes, it is.
20         Q.       Was that labeled like that
21   before you received it?
22         A.       Yes, it was.
23         Q.       Did you read it?
24         A.       I scanned it.  I did not study
25   it.  It's not my area.
0023
 1         Q.       So you're not qualified to even
 2   understand what it's saying; is that --
 3         A.       No, ma'am.
 4         Q.       -- true?  Okay.
 5                  Then we have the American
 6   College of Cardiology, American Heart
 7   Association Practice Guidelines.
 8                  Again, I assume you would have
 9   never seen this prior to Mr. Kulwicki sending
10   it to you?
11         A.       As far as I know, I didn't see
12   it before he sent it to me.
13         Q.       You are not an expert in the
14   subject of electrophysiology to be able to
15   comment on these?
16         A.       I am not.
17         Q.       We have another copy of the
18   Heart Rhythm Society Guidelines.
19                  Another copy of Stacy Poe's
20   deposition.
21                  Looks like you were provided
22   with a copy of some of the materials that were
23   on the Cleveland Clinic Web site at the time?
24         A.       Yes.
25         Q.       And you reviewed that?
0024
 1         A.       Yes.
 2                  MS. CARULAS:  We'll mark that as
 3         Exhibit F.
 4                       - - -
 5                  (Whereupon, Exhibit F is marked
 6         for identification.)
 7                       - - -
 8   BY MS. CARULAS:
 9         Q.       There is some highlighting in
10   yellow.
11                  Is that your highlighting?
12         A.       I believe it is.  Can I look at
13   this just to verify?
14         Q.       Absolutely.
15         A.       I have to say I don't remember
16   that this is my highlighting, but it might be.
17   I believe it probably is.  Nothing else I
18   received was highlighted in any color.  So it
19   probably is.
20         Q.       All right.  And the section that
21   was highlighted is the statement there, "Are
22   there any risks?"  And it says, "The pulmonary
23   vein antrum isolation procedure is generally
24   very safe.  However, as with any invasive
25   procedure, there are risks to ablation."
0025
 1         A.       That's what it says.
 2         Q.       Then you have a variety of --
 3   well, let's see what you have.
 4                  So you have, it looks like,
 5   Dr. Burkhardt's record --
 6         A.       Yes.
 7         Q.       -- that's in the form of a
 8   letter to Dr. Makino, dated August 17th, 2006,
 9   correct?
10         A.       Correct.
11         Q.       And you're aware of his
12   documentation in there that he did discuss the
13   procedure in detail and discussed the risks,
14   benefits and alternatives to Mr. Sullivan?
15         A.       That's what he says in the
16   letter.
17         Q.       Then he documented that, "He
18   consents to the procedure and wishes to
19   proceed," correct?
20         A.       That's what the letter says.
21         Q.       We're going to get into it in
22   great detail --
23         A.       Yeah.
24         Q.       -- but you are not questioning
25   Dr. Burkhardt's integrity in putting this in
0026
 1   the note, are you?
 2         A.       I'm not questioning the
 3   integrity of anybody in this case, or the
 4   institution.
 5         Q.       You're not disputing from
 6   Dr. Burkhardt's statement that he did have a
 7   discussion with him?  I mean, you're not
 8   disputing that?
 9         A.       I'm not disputing it.  If he
10   says he had a discussion, then I will take him
11   at his word.
12         Q.       Now, then we have
13   Dr. Burkhardt's -- a lot of the technical
14   records here from the procedure at the
15   Cleveland Clinic, which is in your file, but I
16   assume, again, you're not competent to
17   interpret those?
18         A.       That's correct.
19         Q.       Then you have the deposition of
20   Debbie Sullivan, correct?
21         A.       Yes.
22         Q.       And it doesn't look like you
23   stickied or dog-eared any of that, correct?
24         A.       Correct.
25         Q.       Then you have a binder here of
0027
 1   some records.  And I want to make sure I know
 2   what all of these are.
 3                  So it looks like initially,
 4   there are some records of Dr. Makino, do you
 5   think?  Or do you know what these are?  Maybe
 6   you can take a look.
 7         A.       I'll have to remind myself.
 8         Q.       Sure (handing).
 9         A.       So this -- these are office
10   notes from Dr. Makino.  Yeah, they're all from
11   the file of Dr. Makino in Hawaii --
12         Q.       Did you read --
13         A.       -- so it appears.  I read these
14   so I could get a larger understanding of what
15   happened in Hawaii.
16         Q.       Did those come with the initial
17   stack or did you just receive those recently?
18         A.       Oh, these came with the initial
19   stack.  Certainly, it wasn't recent.  It was
20   some time ago.
21         Q.       Was there anything significant
22   to Dr. Makino's records to what you have to
23   offer in this case?
24         A.       Well, and perhaps we'll talk
25   about this some more, it wasn't clear to me
0028
 1   that Dr. Makino's conversations with the
 2   Sullivans were exactly the same -- was the same
 3   information as the Sullivans got in Cleveland.
 4   So that leads to a larger concern that we can
 5   talk about.
 6         Q.       All right.  So then you have the
 7   records of Dr. Shen, correct?
 8         A.       Yes.
 9         Q.       Who is Dr. Shen, do you recall?
10         A.       I don't recall.  He was some --
11   was he a consultant?  Was he a consultant in
12   Hawaii?  I don't remember.
13         Q.       Okay.
14         A.       Right.  He was one of the other
15   physicians in -- in Hawaii who takes care of
16   Mr. Sullivan, I gather.
17         Q.       Were his records of any
18   significance to your opinions?
19         A.       I don't believe so, other than
20   just giving me the general lay of the land.
21         Q.       Then you have some records of
22   Dr. Hong.
23                  Do you remember who Dr. Hong
24   was?
25         A.       Another caregiver in Hawaii, as
0029
 1   I recall, for Mr. Sullivan.
 2         Q.       Do you recall if there was any
 3   significance to Dr. Hong's records?
 4         A.       No.
 5         Q.       No, you don't, or there weren't?
 6         A.       There was no -- I don't recall
 7   any significance to those records for me.
 8         Q.       It looks like we have a loose
 9   page of -- Pages 19 and 20 of Dr. Cummings' CV.
10         A.       Yes.
11         Q.       And then some other clinical
12   notes, which I assume have no significance to
13   your --
14         A.       Can I just look for a moment?
15         Q.       Sure.
16         A.       And there's an article here, if
17   you want to note it.
18         Q.       Oh, yes.  I didn't see that.
19                  So then you have mixed in with
20   some records, additional clinical records.
21   Then there is an article where the lead author
22   is Patel, P-a-t-e-l, "Long-term functional and
23   neurocognitive recovery"; is that correct?
24         A.       Yes.
25         Q.       Do you believe then this
0030
 1   encompasses the entirety of what you've
 2   reviewed prior to authoring your report --
 3         A.       I do.
 4         Q.       -- or for your opinions in this
 5   case?
 6         A.       I do.
 7         Q.       Have you reviewed any other
 8   literature to support your opinions in this
 9   case?
10         A.       I have not reviewed any of the
11   literature directly as a result of my
12   involvement in this case.  I'm always reading
13   the literature.  And this just happens to be
14   one of my interests, is the ethics of
15   innovative surgery or surgical research.
16         Q.       Is there any literature that you
17   are specifically relying on for the opinions
18   you propose to give in this case?
19         A.       There's no specific item that
20   I'm relying on.  I'm relying on reading over
21   30-plus years in the field of medical ethics.
22         Q.       But as far as quoting any
23   particular, this article supports your opinion
24   in this case --
25         A.       I'm not --
0031
 1         Q.       -- you don't have a specific
 2   article that you are so citing?
 3         A.       No.
 4         Q.       Now, can you give me an idea,
 5   sir, as to prior to authoring your report to
 6   Mr. Kulwicki -- and your report is dated
 7   January 12th, 2011 --
 8         A.       It's not.
 9         Q.       Do you have a different report?
10         A.       What I have, I have January 7th.
11         Q.       Okay.  Let me see that.
12                  MR. KULWICKI:  I think, Anna,
13         for purposes of the record, I think what
14         happened is, they're exactly the same.
15         Dr. Moreno, because we were up against a
16         deadline, had e-mailed the unsigned
17         report, and I forwarded that to you.
18                  THE WITNESS:  That's right.
19                  MR. KULWICKI:  And then you put
20         it onto your letterhead and sent it again
21         with a new date, but everything else was
22         the same.
23                  MS. CARULAS:  Okay.
24                  MR. KULWICKI:  Just so you know.
25                  What did you mark those, by the
0032
 1         way?
 2                  MS. CARULAS:  So this one is
 3         marked Exhibit G.
 4                       - - -
 5                  (Whereupon, Exhibit G is marked
 6         for identification.)
 7                       - - -
 8                  MS. CARULAS:  I'll just take a
 9         look, if I can.
10                  THE WITNESS:  Sure.
11                  (Pause)
12   BY MS. CARULAS:
13         Q.       Now, prior to this report, which
14   apparently is on letterhead dated January 7th
15   and was sent with your -- is this Washington,
16   D.C. address at your home?
17         A.       Yes.
18         Q.       That was e-mailed.
19                  Other than these two forms, have
20   you authored any other reports or summaries in
21   this case?
22         A.       No, I have not.
23         Q.       Did you, prior to sending this
24   report, send any drafts at all or any initial
25   versions of it?
0033
 1         A.       I don't recall if I did.  I
 2   might have done so.  I'm not remembering now if
 3   I did.
 4         Q.       All right.  Was that something
 5   you would have a copy of, an initial draft?
 6         A.       I overwrite routinely these
 7   things.
 8         Q.       Did you ever send an initial
 9   draft to Mr. Kulwicki?
10         A.       I might have done.  I don't
11   remember it.  We might have exchanged
12   conversation about an initial draft.  I just
13   don't remember.
14         Q.       Do you recall anything that was
15   changed between an initial draft and your final
16   report in this case?
17         A.       Well, nothing substantive was
18   changed.  As I thought more about the case, I'm
19   sure I added statements.  So in that sense,
20   there was change.
21         Q.       So when you first wrote your
22   report -- and do you know when it first was
23   that you sent a report to Mr. Kulwicki?
24         A.       Well, all I know is these
25   particular dates.
0034
 1         Q.       Okay.
 2         A.       I would have been thinking about
 3   it in December and might have jotted some
 4   thoughts down in December last year.
 5         Q.       Then you say you spoke with
 6   Mr. Kulwicki?
 7         A.       I might have done.  I don't
 8   remember.
 9         Q.       And you say you know that
10   certain things were added?
11         A.       Right.  Well, as one starts to
12   draft a statement, one thinks some more and
13   adds some more ideas.
14         Q.       What were some of the more ideas
15   that one came to as one thought through it?
16         A.       Well-put.  Gee, unfortunately, I
17   don't specifically recall what might have come
18   later.
19                  It's possible, because I was --
20   well, this would make sense.  I was really
21   focusing on the clinical side of the case, what
22   we would call clinical ethics of the informed
23   consent.
24                  I think I then started thinking
25   more about the medical registry aspect.  And so
0035
 1   probably -- probably that ninth item on the
 2   registry was something that I would have
 3   thought about after I thought about the
 4   clinical ethics piece.
 5         Q.       Is that something, the registry
 6   issue that was raised as a point of discussion,
 7   raised by Mr. Kulwicki to you?
 8         A.       It was a question that came up
 9   early.  It might have been in the first
10   conversation we had on the telephone.  I don't
11   remember.  But it was a question that came up
12   between us.
13         Q.       So the --
14         A.       I think that I raised the
15   question whether this was related to any
16   research study.
17         Q.       Okay.
18         A.       And then he responded by calling
19   my attention to the registry verbally and then
20   had the information in writing.
21         Q.       But then when you first drafted
22   your report, you didn't have anything in there
23   about the registry, but then you subsequently
24   added that for the final report; is that your
25   recollection?
0036
 1         A.       Yes.  Can I only note --
 2         Q.       Sure.
 3         A.       Well, that is not exactly my
 4   recollection.  I'm sure I was thinking about
 5   these issues in parallel.  Then as I thought
 6   about it some more, I decided it was time to
 7   commit a statement to paper.
 8                  Also, can I point out that my
 9   name is misspelled on the exhibit note.  It's
10   M-o-r-e-n-o, not M-a-r-i-n-o.
11         Q.       Oh.  Well, we'll change all of
12   those.  How about if we do all of that at the
13   end.
14         A.       You don't take offense.
15         Q.       No, no, no.  We'll change all of
16   them.
17         A.       It just might cause confusion
18   later for you.
19         Q.       No, I appreciate that.  We'll
20   change them all before we leave.
21         A.       That's not a hard one.
22         Q.       So back to, you believe that
23   when you initially encapsulated your opinions
24   into a report, that you did not have number
25   nine on there and then subsequently added that,
0037
 1   true?
 2         A.       That's -- that's entirely
 3   possible.  Frankly, I was so astonished that
 4   there was no consent form that was signed by
 5   the patient, that that was where my first line
 6   of thinking went and the implications of that.
 7                  And then I probably logically
 8   went through adequacy of consent after that and
 9   then the research question.
10         Q.       And then this last issue about
11   the remote magnetic navigation, I assume you
12   have no expertise at all in remote magnetic
13   navigation?
14         A.       I don't.  But when I was reading
15   the papers, it looked as though that was
16   clearly thought to be a novel or innovative
17   procedure.
18         Q.       And the papers were sent to you
19   about by Kulwicki, correct?
20         A.       Yes, ma'am.
21         Q.       So fair enough that Mr. Kulwicki
22   raised the issue of the remote magnetic
23   navigation to you as opposed to you raising it
24   to him?
25         A.       I honestly don't remember the
0038
 1   order in which, whether I raised the question
 2   or he did.  I don't remember that.
 3         Q.       Prior to this particular case,
 4   were you familiar at all with remote magnetic
 5   navigation used in pulmonary vein ablation
 6   procedures?
 7         A.       Well, familiar may be a bit
 8   generous.  I've heard it discussed at meetings
 9   as an example of a procedure.  But I would not
10   say that I was familiar with it.  I had heard
11   about it.
12         Q.       Right.  Now, what is your
13   experience in medical-legal matters?
14         A.       Well, I've been an expert on a
15   number of legal cases since the late 1990s for
16   both sides, as it were.  I've given testimony
17   in one court.  And I've been deposed -- and I
18   don't keep records of this, but I would guess
19   that I've been deposed about 15 or 20 times.
20         Q.       How many cases have you actually
21   reviewed for lawyers?
22         A.       So it depends how one defines
23   review.  A couple of times a year, a lawyer
24   might call me and ask to talk about something
25   on the phone or ask me to look at something.
0039
 1   And, generally, that's as far as it goes.
 2                  And in a minority of instances,
 3   a lawyer would retain me to look at more
 4   documents.
 5         Q.       So on how many in a given year
 6   is your opinion requested?
 7         A.       Oh, well, including these sort
 8   of phone calls that don't amount to any
 9   relationship, maybe three times a year.
10         Q.       Now, the one case that you
11   testified in court, where was that?
12         A.       That was in -- in Boston, in the
13   federal court.  I'm not a lawyer, so my
14   knowledge of which court is which is a little
15   vague.  But it's the really nice courthouse on
16   the water next to the big dig.
17         Q.       Right.
18         A.       And that was 1999, I believe.
19         Q.       Who were you retained by in that
20   case?
21         A.       I don't remember his name.  It
22   was a lawyer in Rockville, Maryland.
23         Q.       Who did the lawyer represent?
24         A.       He and a number of other lawyers
25   represented the families of people who had
0040
 1   claimed they had been used unethically in an --
 2   a human experiment in the 1950s at
 3   Massachusetts General Hospital.
 4         Q.       And you testified on behalf of
 5   the families.
 6                  What was the substance of your
 7   testimony?
 8         A.       This was a fascinating case that
 9   involved using ionizing radiation -- in the
10   news these days because of Japan -- to try to
11   destroy cancer cells, glioblastoma cells in the
12   brain.
13                  And I had been a senior staff
14   member of a presidential advisory commission on
15   the use of ionizing radiation in human
16   experiments.  And so I was there to testify
17   about the development of research ethics,
18   policies and government standards on ionizing
19   radiation in medicine.
20         Q.       Now, you say then you've given
21   about 15 to 20 depositions otherwise, correct?
22         A.       That is probably right.
23         Q.       Have you ever given a deposition
24   in a case out of Ohio?
25         A.       Yes.  In fact, now that you
0041
 1   mention it, it's a case that is cited here.
 2   And if you ask me the name of the case, I won't
 3   remember it.  But this also had to do with an
 4   informed consent problem in Ohio.  And I did
 5   notice that that case was cited in one of the
 6   legal documents that I saw.
 7         Q.       Oh.  What legal document did you
 8   see?
 9         A.       I was afraid you would ask me
10   that.  I think it might have been the one that
11   is a printout of the -- of the law in Ohio.
12         Q.       Was it the Request for
13   Admissions, this (indicating)?
14         A.       No, no.  It was that printout of
15   the law, the Ohio statute on informed consent,
16   perhaps.
17         Q.       Oh, I see.  I marked that.
18         A.       Yes, the LexisNexis.  So I'm
19   going with memory here.  This is a 1999 case.
20   This is in Stewart versus Cleveland Clinic.
21   And I believe that's a case in which I was an
22   expert.
23         Q.       Who retained you in that case,
24   do you know?
25         A.       I don't remember.  Oh, it was
0042
 1   the -- it was the plaintiff in that case.  It
 2   was the attorneys for Stewart.
 3         Q.       Do you recall what the issues
 4   were?
 5         A.       They were informed consent
 6   issues.  And I don't remember in detail what
 7   they were.
 8         Q.       Now, that would be your only
 9   experience in Ohio?
10         A.       As far as I could recall.
11         Q.       Now, what are the other states
12   that you have been involved in giving
13   depositions in cases?
14         A.       Well, let me do my best here.
15   That case that I mentioned from the late '90s
16   in which I testified involved New York and
17   Massachusetts.  Cases in the District of
18   Columbia.  I'm going to say there was a case in
19   Maryland.
20                  This is scary when you get to be
21   this age and have to go through the memory
22   banks.
23                  New Jersey.  I think that might
24   be -- Nevada, I think, but that never became a
25   deposition.  I think that might be it.
0043
 1         Q.       All right.  Now --
 2         A.       Oh, Florida.
 3         Q.       In all of these cases, were you
 4   retained on behalf of the plaintiff?
 5         A.       In -- in at least one of the
 6   recent cases that I remember, I was retained a
 7   couple of years ago for the defense.  And that
 8   was a New Jersey case that involved a question
 9   of whether a particular individual must have
10   been admitted to a compassionate use of
11   trial -- or to use a device that was in a
12   clinical trial, but admitted for what is known
13   as compassion of use.
14         Q.       Did that go to a deposition?
15         A.       It did not.
16         Q.       You were asked to review it on
17   behalf of the defense.
18                  Were you able to support the
19   defense side of the case?
20         A.       I agreed with the defense in
21   that case.
22         Q.       And all the other cases were on
23   behalf of the plaintiff?
24         A.       I wouldn't say all.  The
25   majority of them were on behalf of the
0044
 1   plaintiff.
 2         Q.       Can you think of any other case
 3   that was on behalf of the defense?
 4         A.       This -- so this never also got
 5   to a deposition.  There was a meeting that I
 6   had maybe eight years ago, when I was still at
 7   the University of Virginia.  And if memory
 8   serves, they were from Nevada.  The question
 9   there had to do with responsibility for the
10   so-called downwinders of ionizing radiation.
11   And as I recall, they were representatives of
12   the university.
13                  So that's my recollection.
14         Q.       All right.  Any others you can
15   recall on behalf of the defense?
16                  Were you able to support the
17   defendant's side on that case?
18         A.       That never went further than a
19   conversation in my office.
20         Q.       I see.  Does that mean because
21   you were unable --
22         A.       I don't know why.
23         Q.       You don't know?
24         A.       I don't know why.
25         Q.       Of these other cases, you state
0045
 1   the majority were for the plaintiff.
 2         A.       Yes.
 3         Q.       Have your qualifications to give
 4   testimony, to your knowledge, ever been raised
 5   and you have been disqualified to testify?
 6         A.       I've been disqualified once on
 7   the grounds that I'm not a medical doctor who
 8   specialized in that area of medicine.
 9         Q.       Where was that case?
10         A.       I believe that was Maryland.
11         Q.       Do you remember the specifics of
12   the case?
13         A.       It was a -- I don't.  It was a
14   case that involved Kaiser Permanente, I
15   believe.  But I do not remember the specifics
16   of that case.  That was about 13 years ago.
17         Q.       Do you remember the nature of
18   the type of medical procedure or issue that
19   was --
20         A.       I think that they were looking
21   for people in internal medicine, as I recall.
22         Q.       Do you remember what the issue
23   was?
24         A.       I don't.
25         Q.       Do you remember the name of the
0046
 1   the case?
 2         A.       I don't.
 3         Q.       Any other cases where you can
 4   recall that it got to the point where you were
 5   disqualified by the court?
 6         A.       No.
 7         Q.       Is it possible there were others
 8   and you say, because only one went on to
 9   trial --
10         A.       Yeah.
11         Q.       -- that you just don't know the
12   details of it?  If you know.
13         A.       I don't know.  I think that
14   would stick in my mind as -- because I find
15   it -- I find it interesting how one
16   distinguishes between the ethical issues and
17   the medical issues.
18                  And I think I would probably --
19   I would probably remember if I had been
20   disqualified from another one.
21         Q.       Okay.
22         A.       I should also add that I have
23   turned down cases or advised plaintiff
24   attorneys not to pursue cases.
25                  MS. CARULAS:  All right.  I have
0047
 1         a copy of your CV that was provided to
 2         me.  I'm trying to keep everything
 3         separate here.
 4                  What are we up to, do you know?
 5                  THE COURT REPORTER:  Exhibit H,
 6         I think.
 7                       - - -
 8                  (Whereupon, Exhibit H is marked
 9         for identification.)
10                       - - -
11   BY MS. CARULAS:
12         Q.       So I've marked your CV as
13   Exhibit H.  And I'm not going to go through it
14   in great detail in the interest of time.
15                  But it's my understanding that
16   your education is in the field of philosophy;
17   is that correct?
18         A.       Yes, it is.
19         Q.       Is it a master's in philosophy?
20         A.       I didn't do that.  I only got a
21   Ph.D.
22         Q.       You did an undergrad in
23   philosophy --
24         A.       And psychology, yes.
25         Q.       -- was your degree?
0048
 1         A.       I'm sorry.  I did an
 2   undergraduate degree in philosophy and
 3   psychology.  And my Ph.D. is in philosophy.
 4         Q.       In philosophy, all right.
 5                  You are not a medical doctor?
 6         A.       I'm not.
 7         Q.       You have no medical education or
 8   training?
 9         A.       I have no formal medical
10   education or training.
11         Q.       You do not hold any licensure in
12   a medical field, correct?
13         A.       That is correct.
14         Q.       And you do not hold any
15   licensure in any field, correct?
16         A.       That's correct.
17         Q.       You're not a lawyer, correct?
18         A.       I am not.
19         Q.       And you do not have an active
20   license to practice law?
21         A.       No, I don't.
22         Q.       I know I've read a few of your
23   publications.
24         A.       Thank you.
25         Q.       You're welcome.
0049
 1                  And I see that you describe
 2   yourself in these publications as a layperson?
 3         A.       Yes, with respect to medicine.
 4         Q.       You do not hold yourself out as
 5   a medical professional, correct?
 6         A.       I would not hold myself out as a
 7   medical professional in the normal sense of the
 8   term.
 9         Q.       Now, your employer is whom?
10         A.       The University of Pennsylvania.
11         Q.       Are you actually employed by the
12   medical school or by the undergraduate school?
13         A.       So I have a somewhat unusual
14   position.  I have an endowed share that tenures
15   me in both the Medical School and the School of
16   Arts and Sciences.
17         Q.       But while you have an
18   appointment of sorts, you're actually an
19   employee of the undergraduate institute; is
20   that --
21         A.       No.  I'm actually an employee of
22   the University of Pennsylvania.  My tenure
23   homes are both the Medical School and the
24   School of Arts and Sciences.
25         Q.       Okay.  Now, you are not employed
0050
 1   by the Hospital of the University of
 2   Pennsylvania, correct?
 3         A.       That's correct.
 4         Q.       Do you have any type of
 5   appointment at all at the Hospital of the
 6   University of Pennsylvania?
 7         A.       I do not.
 8         Q.       And you've been here now at the
 9   University of Pennsylvania for how long?
10         A.       Since January 2007.
11         Q.       Have you ever, at any point in
12   time, been actually employed by a hospital or a
13   medical center as opposed to the university?
14         A.       Well, at the University of
15   Virginia, I was -- my chair and my tenure were
16   in the medical school.  I'm not sure what the
17   corporate description would be with respect to
18   my position.
19                  At -- at the State University of
20   New York, Downstate Medical Center, I was a
21   professor.  That medical center includes both a
22   medical school and a state hospital and a city
23   hospital.
24                  Again, I'm not sure how you
25   would distinguish the responsibilities that one
0051
 1   would have with respect to the medical school
 2   or the hospital.
 3         Q.       Okay.
 4         A.       But that was a medical -- that
 5   is a medical center.
 6         Q.       But you have technically always
 7   been considered an employee of a university?
 8         A.       Yes.
 9         Q.       Now, I know you said you did not
10   recognize the name of the individual who is the
11   electrophysiology expert here at the University
12   of Pennsylvania?
13         A.       I don't know the man.
14         Q.       Can you name any of the
15   electrophysiologists that practice at the
16   Hospital of the University of Pennsylvania?
17         A.       Not offhand.
18         Q.       Dr. Callans, C-a-l-l-a-n-s, is
19   the expert involved in this case from an
20   electrophysiology perspective.
21                  Prior to Mr. Kulwicki telling
22   you that he was involved in the case, I assume
23   you've never heard of Dr. Callans?
24         A.       I don't remember hearing his
25   name before.
0052
 1         Q.       Have you ever heard of
 2   Dr. Marchlinski, M-a-r-c-h-l-i-n-s-k-i?
 3         A.       No.
 4         Q.       So I take it you have no
 5   interaction whatsoever with the
 6   electrophysiology department at the Hospital of
 7   the University of Pennsylvania?
 8         A.       Not so far as I recall.  It may
 9   be that I've attended a case conference where
10   there are people from the department who are
11   present.  But nothing registers.
12         Q.       As you sit here today, you
13   cannot say that you've ever participated in a
14   meeting with the electrophysiology department
15   at the Hospital of the University of
16   Pennsylvania?
17         A.       That's correct.
18         Q.       Have you ever interacted, to
19   your knowledge, with any of the other
20   cardiologists at the Hospital of the University
21   of Pennsylvania other than the specialists in
22   electrophysiology?
23         A.       I'm sorry, can you rephrase
24   that?
25         Q.       Sure.  That was really garbled
0053
 1   and long.  I apologize.
 2                  The same question about just the
 3   general department of cardiology.  Do you have
 4   a recollection of ever interacting with anyone,
 5   even a non-specialist, not an
 6   electrophysiologist, at the Hospital of the
 7   University of Pennsylvania?
 8         A.       I do not.
 9         Q.       As far as the medical issues in
10   this case, one of the issues here, of course,
11   is atrial fibrillation.
12         A.       Yes.
13         Q.       Would it be fair to say that you
14   have no expertise, beyond that of a layperson,
15   to share with the jury on the subject of atrial
16   fibrillation?
17         A.       That's correct.
18         Q.       And as far as the treatment for
19   atrial fibrillation, you have no expertise
20   beyond that of a layperson?
21         A.       That's correct.
22         Q.       As far as the risks of atrial
23   fibrillation or the risks of any alternative
24   treatments for atrial fibrillation, you have no
25   expertise beyond that of the average layperson
0054
 1   to share with the jury?
 2         A.       That's correct.
 3         Q.       And as far as the actual
 4   catheter ablation procedure that was performed
 5   in this case, the risks of that, any of the
 6   details of that procedure, the instruments
 7   used, any of that, you have no expertise beyond
 8   that of a layperson to share with the jury?
 9         A.       Yes.
10         Q.       Have you, sir, ever personally
11   been responsible to have an informed consent
12   discussion with a patient who underwent a
13   pulmonary vein antrum isolation procedure?
14         A.       No.
15         Q.       Have you ever personally had the
16   responsibility to give an informed consent
17   discussion with a patient to undergo any type
18   of electrophysiology procedure?
19         A.       No, I have not.
20         Q.       Have you ever sat in on a
21   discussion that an electrophysiology specialist
22   here at the Hospital of the University of
23   Pennsylvania had with their patients?
24         A.       No.
25         Q.       Have you ever, at any of the
0055
 1   medical schools where you have worked over your
 2   career, ever sat in on an informed consent
 3   discussion between the electrophysiologist and
 4   the patient?
 5         A.       I don't recall that I have.
 6         Q.       Have you ever been involved in
 7   drafting a consent form for a pulmonary vein
 8   antrum isolation procedure?
 9         A.       No.
10         Q.       Would you feel competent and
11   qualified to put together a specific consent
12   form on the issues of a pulmonary vein antrum
13   isolation procedure?
14         A.       On the technical medical issues?
15         Q.       Yes.
16         A.       No.  Let me qualify that.  I and
17   other people who do bioethics often have a role
18   in reviewing draft consent forms and helping
19   colleagues in medicine think about how to
20   express risks, benefits, alternatives in the
21   consent form.
22                  But, of course, with respect to
23   medical questions of a technical nature, I'm
24   dependent on what they tell me.  And then we
25   worry about how to describe it.
0056
 1         Q.       All right.  You've mentioned
 2   that you've never participated in putting
 3   together a consent form for this type of
 4   procedure that was used in this case?
 5         A.       As far as I remember.
 6         Q.       Have you ever assisted -- I
 7   guess I know the answer already, because you
 8   don't think you have ever interacted with the
 9   cardiology department at the Hospital of the
10   University of Pennsylvania.
11                  I assume you have never
12   participated in putting together any type of
13   consent form at the Hospital of the University
14   of Pennsylvania?
15         A.       Not at Penn, no.
16         Q.       In prior years, have you been
17   involved in that?
18         A.       Yes.
19         Q.       Whereabouts?
20         A.       I would have been involved at
21   Downstate Medical Center in New York.  And if
22   memory serves, at the University of Virginia.
23         Q.       You were at -- I'm sorry, it's
24   Downstate?
25         A.       It's the State University of New
0057
 1   York, often called --
 2         Q.       SUNY?
 3         A.       -- Downstate Medical Center,
 4   SUNY.
 5         Q.       Now, there's Dr. Levine who's
 6   testifying in this case.  I think he's at SUNY.
 7                  Do you know him?
 8         A.       Can you tell me the first name?
 9         Q.       Steven, S-t-e-v-e-n.
10         A.       It -- it's not unfamiliar.  But
11   I know a lot of -- a few Steve Levines, I
12   think, and so I may be echoing the name.
13         Q.       You had no knowledge he was in
14   the case.  So I assume you had no knowledge
15   and --
16         A.       No, ma'am.  I didn't know he was
17   in the case.  And I have no idea what he would
18   say.
19         Q.       I'm sorry, you were at Downstate
20   SUNY; is that --
21         A.       Yes.
22         Q.       What years?
23         A.       1989 to 1998.
24         Q.       Do you recall what type of
25   consent forms you helped put together?
0058
 1         A.       I don't.  Specifically, there
 2   were -- I was a member of the IRB for several
 3   years.  And it was fairly common for us to go
 4   through consent forms and make suggestions and
 5   require some changes.  And that would have been
 6   the primary setting in which I would have been
 7   involved in helping draft consent forms.
 8         Q.       All right.
 9         A.       Or editing consent forms,
10   revising forms.
11         Q.       The primary folks putting those
12   together, I would assume, would be the doctors
13   and the lawyers?
14         A.       Well, one hopes not the lawyers,
15   so much as the people -- the investigators, the
16   medical investigators.
17         Q.       They're the primary ones, the
18   doctor, involved in putting those together?
19         A.       In general, yes.
20         Q.       Then you might put a touch or
21   add something to it?
22         A.       Well, that might be a bit too
23   minimal.  There might have been situations in
24   which we asked for significant revision of the
25   consent form, depending on how confident we
0059
 1   were that the issues that were relevant to the
 2   patients or patient subjects were being
 3   addressed in that draft.
 4         Q.       Can you, as you sit here today,
 5   recall any of the types of procedures you gave
 6   input on regarding a consent form?
 7         A.       You know, it was a -- there was
 8   only one IRB for Downstate.  And the -- so we
 9   would have seen pretty much -- we would have
10   seen everything in every department.  At least
11   we should have.  Two areas that were very
12   prominent in my recollection were HIV AIDS and
13   oncology.  Particularly in gynecologic
14   oncology, there was a lot of work being done at
15   that time.
16         Q.       Can you recall ever
17   participating or giving input regarding a
18   surgical procedure?
19         A.       I'm confident that I did.  I
20   don't recall specifics right now, but I had a
21   substantial role in talking to physicians at
22   Downstate.
23         Q.       Ever recall, at Downstate,
24   interacting at all or putting together a
25   consent form regarding an electrophysiology
0060
 1   procedure?
 2         A.       I don't recall that.
 3         Q.       And then you say, if memory
 4   serves you, you might have been involved in
 5   this process at UVA?
 6         A.       Yes.  Again, now at UVA, I was
 7   not on the IRB.  I was a consultant to the IRB.
 8   And there would be telephone conversations
 9   trying to sort out details of consent forms,
10   what should be disclosed and what shouldn't be.
11                  I was also on the ethics
12   consultation service for the hospital.  And
13   questions about consent forms undoubtedly came
14   up.  I can't recall a particular one at this
15   time.
16         Q.       And you were at UVA when?
17         A.       From 1998 to 2006.
18         Q.       Do you recall ever being
19   involved in giving input on a consent form at
20   UVA regarding an electrophysiology procedure?
21         A.       I don't.
22         Q.       You've already told me you are
23   not a lawyer, correct?
24         A.       Yes.
25         Q.       So, obviously, you are not a
0061
 1   judge, true?
 2         A.       Not yet.
 3         Q.       And so you would agree that you
 4   are not qualified to give a legal opinion?
 5         A.       That's correct.
 6         Q.       Now, prior to authoring your
 7   report in this case dated --
 8         A.       January.
 9         Q.       -- January of 2011, Mr. Kulwicki
10   had provided you with what we have marked as
11   Exhibit D, which is portions of an Ohio revised
12   code provision, correct?
13         A.       Yes.
14         Q.       Prior to that, were you provided
15   with any other summary or description of what
16   Ohio law says regarding informed consent?
17         A.       No.  Now, it's possible I was
18   provided with something during that Stewart
19   case, if that is, in fact, the case that I
20   participated in 12 years ago.  But I don't -- I
21   certainly did not consciously rely on anything
22   about Ohio law.
23         Q.       So for your opinions in this
24   case, did you take into consideration Ohio law?
25         A.       Well, no.  I'm not a lawyer.
0062
 1   I'm not even sure I know how to apply or
 2   interpret Ohio law.  So I was really interested
 3   in the ethical standards.
 4         Q.       All right.  Now, you would
 5   agree, sir, that there can be indeed a
 6   difference between --
 7         A.       Law and ethics?
 8         Q.       -- law and ethics?  Thank you.
 9         A.       Yes, there can be.
10         Q.       And you've discussed, I know,
11   from some of your readings, that you consider
12   yourself a philosopher, correct?
13         A.       My colleagues in philosophy
14   would probably blanch at that statement.  But I
15   consider myself still to be a philosopher by
16   discipline.
17         Q.       As a philosopher, how you've
18   described it in some of your publications is,
19   you talk about ethics and moral codes?
20         A.       Yes, ma'am.
21         Q.       And some of your publications
22   was that ethics and moral codes really begin in
23   childhood and are brought to us by our parents,
24   correct?
25         A.       Well, that's a -- that's a sort
0063
 1   of moral development view.  I guess I prefer to
 2   say that our ethical and moral codes are part
 3   of the growth of development of civilization.
 4   And that, as individuals, we -- as the old
 5   saying used to go, we learn about then what our
 6   mothers need.
 7         Q.       I think that's what I had read.
 8   Okay.
 9                  And you would agree that the
10   usual of ethics and morals is, by nature,
11   subjective?
12         A.       No, I wouldn't.
13         Q.       Okay.
14         A.       I think there are universal
15   principles of ethics.  I would not want to call
16   them subjective insofar as that suggests that
17   they're somehow relative.
18                  I do agree that those principles
19   must require interpretation.  But I don't
20   believe that they're subjective.
21         Q.       In a given situation, different
22   people can interpret --
23         A.       The principles in different
24   ways.
25         Q.       Okay.
0064
 1         A.       And that's why it's especially
 2   important to have professional organizations
 3   and conversations with professionals about what
 4   the proper interpretation and application of a
 5   principle should be.
 6         Q.       Now, when we talk about law on
 7   the one hand and ethics on the other, we know
 8   under the law, ultimately a judge can determine
 9   or does determine what is legal or not legal.
10   True?
11         A.       That's my understanding.
12         Q.       And sometimes there can be
13   certain things that are legal in some states,
14   yet different individuals would have differing
15   opinions as to whether or not the law is
16   ethical?
17                  MR. KULWICKI:  Object.  You can
18         answer if you understand.
19         A.       I'm going to ask you to repeat
20   that one.
21   BY MS. CARULAS:
22         Q.       Sure.  There are certain laws on
23   the books that are there from one state to
24   another.  For instance, capital punishment,
25   right?
0065
 1         A.       Yes, ma'am.
 2         Q.       In some states, capital
 3   punishment is legal.  In other states, it's not
 4   legal, correct?
 5         A.       That's correct.
 6         Q.       And it's essentially governed by
 7   state law, true?
 8         A.       As I understand it.  Except for
 9   the constitutional question, cruel and unusual
10   punishment, but yes.
11         Q.       Now, while capital punishment is
12   legal in some states, laypeople -- not judges,
13   lay people -- looking at that, some will
14   believe capital punishment is ethical and some
15   disagree and believe it's not ethical, true?
16         A.       Well, I guess I'd qualify it.
17   It looks to me as though judges disagree as
18   well, even within a single state, at least with
19   respect to the procedures required by the
20   constitution for -- for capital punishment.
21                  So judges do disagree.  And one
22   of the ways that the law progresses organically
23   is through colloquies over the generations
24   among judges, lawyers, laypeople and experts.
25         Q.       From an ethical standpoint,
0066
 1   there can be different interpretations of
 2   whether or not a given situation is ethical or
 3   not ethical?
 4         A.       So that's not so obvious to me.
 5         Q.       Okay.
 6         A.       Very often, what are thought to
 7   be ethical disagreements are really
 8   disagreements about facts.
 9                  And my experience in the medical
10   world, there are very few disagreements about
11   ethics.  When you sit down with people and
12   start exploring a case, what you often find out
13   is that there has been -- there is a failure to
14   disagree on the basic facts.  And that once the
15   facts are a matter of agreement, that you can
16   find ways to achieve that moral consensus.
17         Q.       I would assume that part of your
18   job as a professor is, you have panel
19   discussions and debates on given subjects?
20         A.       Actually, that's not the way
21   that most people in bioethics proceed.  That's
22   a popular way to proceed, to have the pros and
23   the cons in a newspaper or a magazine article
24   about ethics.
25                  But people who teach
0067
 1   professional ethics don't like that debating
 2   format.  And the reason is that it seems to
 3   create an adversarial relationship.
 4         Q.       Have you ever moderated panel
 5   discussions on ethical issues?
 6         A.       Countless times.
 7         Q.       What is the purpose of doing
 8   that?
 9         A.       It's to share information, share
10   views, have an exchange.  Sometimes people
11   change their minds about things.  Sometimes
12   they don't.
13                  But it would be reductive to
14   call it a debate, insofar as a debate implies
15   that people come in with fixed positions that
16   they're not going to change no matter what.
17                  You require a level of openness
18   that's not the case in an adversarial
19   situation.
20         Q.       I see.  But nevertheless, issues
21   are openly discussed and people can change
22   their mind or vacillate as far as their
23   interpretations as time goes on?
24         A.       People, one hopes, do change
25   their minds as time goes on.  Otherwise,
0068
 1   there's not a good reason to have that
 2   discussion.
 3         Q.       Now, you say that you did not
 4   use Ohio law as a framework for your opinions
 5   that you authored in your January of 2011
 6   report, true?
 7         A.       To the best of my recollection.
 8         Q.       And I just want to make sure I'm
 9   understanding.  I apologize if I'm repeating.
10         A.       That's okay.
11         Q.       Did Mr. Kulwicki ever tell you
12   whether or not Ohio law requires a written
13   informed consent document?
14         A.       Actually --
15                  MR. KULWICKI:  Objection.
16                  You can answer.
17         A.       (Continuing) -- I'm sure
18   Mr. Kulwicki must have thought I was out of my
19   mind the first time he called me.  Because I
20   remember three times asking him, well, what
21   about the consent form.  And he kept saying,
22   there was no written consent form signed by the
23   patient, which I found absolutely amazing.
24                  And -- and I guess it was either
25   in that conversation or are when he sent me
0069
 1   the -- the statute that I noted that there was
 2   no requirement in the law.
 3   BY MS. CARULAS:
 4         Q.       Okay.  So you do --
 5         A.       That's what it appears to be.
 6                  I have to say, as a non-lawyer
 7   looking at it, I don't know how you would
 8   satisfy the spirit of that statute without
 9   having a patient sign the form.  But I'm not
10   going to put myself in the position of being a
11   lawyer interpreting it.
12         Q.       You obviously will follow the
13   law that the judge sets forth in this case?
14         A.       The judge is the -- is the
15   authority --
16         Q.       Okay.
17         A.       -- as far as the power of the
18   state is concerned.
19         Q.       All right.  Now, I want you to
20   assume this, okay?  And let's talk.  I want you
21   to assume that to succeed on their claim, the
22   plaintiff's claim, for lack of informed
23   consent, the plaintiff must establish that the
24   physician failed to disclose to the patient and
25   discuss the material risks and dangers
0070
 1   inherently and potentially involved with
 2   respect to the proposed therapy, if any.  Okay?
 3                  And then there's two other
 4   elements.  But did you understand what I just
 5   said to you?  Do you want me to read it again?
 6         A.       Yes, I think I understand.  I
 7   mean, you want me to reach a conclusion about
 8   what the law says.
 9         Q.       No.  I'm not going to ask you to
10   reach a conclusion about it.  I want you to
11   assume that.  Okay?
12         A.       Well, all right.
13         Q.       You're grimacing.  What is your
14   problem with it?
15         A.       Well, so whenever you set up a
16   hypothetical, you can ask -- in a friendly way,
17   you can ask the other person to assume almost
18   anything that has all kinds of implications.
19                  I mean, my -- my -- my problem
20   is that the statute fails to do what I think a
21   reasonable person would think the statute would
22   do, which is to ensure that the individual has
23   given informed consent.
24         Q.       Are you aware that actually the
25   Ohio Supreme Court has held that a written
0071
 1   consent form is not a requirement for informed
 2   consent?
 3                  Let me just ask, were you aware
 4   that Mr. Kulwicki told you that?
 5                  MR. KULWICKI:  Are you
 6         suggesting that there's a ruling that
 7         says that Ohio law says that informed
 8         consent is not required in every single
 9         context?
10                  I mean, I think you're
11         misrepresenting the law.  And that's not
12         appropriate.
13                  MS. CARULAS:  Let me strike that
14         and we'll start over.
15         A.       Well, we have agreed before that
16   judges can disagree and the law advances.  And
17   I would say, respectfully, that if anything
18   along the lines of what you described was the
19   conclusion of the Ohio Supreme Court, that the
20   Supreme Court needs to rethink that.
21   BY MS. CARULAS:
22         Q.       Or if it was the Supreme Court
23   or any court --
24         A.       Any court.
25         Q.       -- governing this, you think it
0072
 1   needs to rethink it?
 2         A.       I think that needs to be
 3   rethought.  But I'm not sure -- again, I'm not
 4   sure of the scope of -- what is the scope of
 5   the statement you just made, but I'll take it.
 6         Q.       All right.  In the context of
 7   what the law is, you would agree that you are
 8   not qualified -- I think we've been through
 9   this -- but you are not qualified to say what
10   the material risks and dangers are of this
11   procedure that Dr. Burkhardt, who does this
12   procedure, or Dr. Callans, who does this
13   procedure here at the Hospital of the
14   University of Pennsylvania, you're not
15   qualified to say what risks and dangers an
16   electrophysiologist should tell the patient,
17   true?
18         A.       I am not qualified to describe
19   those risks from a technical point of view.  I
20   would have to be dependent on the information
21   they gave me, if I were helping with the
22   consent form.
23         Q.       So you obviously, as far as the
24   details of what should have been discussed with
25   Mr. Sullivan in this case, you defer to an
0073
 1   electrophysiologist on that?
 2                  MR. KULWICKI:  Objection.
 3         A.       I'm sorry, can you say that
 4   again?
 5   BY MS. CARULAS:
 6         Q.       Sure.  The details of the
 7   procedure, the details of the risks, the
 8   details of the indications for the procedure,
 9   this procedure that Mr. Sullivan underwent, you
10   would defer to an electrophysiologist on that?
11                  MR. KULWICKI:  Objection.
12                  You can answer.
13         A.       I'm sorry, I'm not trying to be
14   argumentative.
15   BY MS. CARULAS:
16         Q.       Yes.
17         A.       "The details."  Can you explain
18   what you mean by "the details"?
19         Q.       Yes.  We've been through it.
20                  You would not even, in your
21   wildest imagination, sit down with a patient
22   and start to tell them what a pulmonary vein
23   antrum isolation procedure would be, how it's
24   performed, what device --
25         A.       I'm comfortable with agreeing
0074
 1   with you in that formulation, yes.
 2         Q.       You would not, in your wildest
 3   imagination, tell them there is this risk or
 4   that risk and the percentage of the risk
 5   because you don't know that.  You're not a
 6   medical doctor and you're certainly not an
 7   electrophysiologist, true?
 8         A.       That's correct.  I would be
 9   interested in how that material is framed, both
10   written and non-written, how the discussion
11   proceeds.
12                  But the technical literature, I
13   would not pretend to be able to convey.  The
14   medical -- specifically technical medical
15   issues, I would not pretend to know in the
16   first -- in the person the way they would.
17         Q.       And you are not qualified and do
18   not plan to say that Dr. Burkhardt's informed
19   consent discussion that he had with Shannon
20   Sullivan was inappropriate, true?
21                  MR. KULWICKI:  Objection.
22                  You can answer.
23         A.       "Inappropriate."  I'm not sure
24   what you mean by "inappropriate."
25   BY MS. CARULAS:
0075
 1         Q.       Yes.  You're not here -- I mean,
 2   Mr. Kulwicki has already conceded this.  You're
 3   not here --
 4         A.       I may not be prepared to concede
 5   everything Mr. Kulwicki does.
 6                  MR. KULWICKI:  Yes.  I don't
 7         know that I have conceded this.
 8                  Go ahead.
 9         A.       (Continuing)  But in any case.
10   BY MS. CARULAS:
11         Q.       As far as you are aware -- we've
12   looked at this -- that Dr. Burkhardt sat down
13   with Shannon Sullivan back on August 16th of
14   2006 and had a discussion with him about the
15   nature of the procedure and the risks and
16   benefits, correct?
17         A.       I'm not claiming that there's
18   anything deceptive about any statements that
19   have been made by the people in -- who, I
20   presume, are operating in good faith in this
21   case.
22         Q.       So I just want to leave here
23   today and make sure I understand.
24                  You are not going to say David
25   Burkhardt was in any way inappropriate in --
0076
 1   well, I mean, you can't say whether or not his
 2   -- and you don't plan to say whether or not his
 3   interaction with Mr. Sullivan was reasonable or
 4   not or met with acceptable standards of care
 5   for an electrophysiologist?
 6                  MR. KULWICKI:  Objection.
 7                  You can answer.
 8         A.       Well, I take him at his word.
 9   If he said he did "X," I -- I take him at his
10   word.  I don't think there is any intentional
11   deception on anybody's part.
12   BY MS. CARULAS:
13         Q.       So assuming that the law is that
14   in order to prove informed consent, plaintiff
15   must prove that the physician -- who we know is
16   David Burkhardt in this case -- failed to
17   disclose to the patient and discuss the
18   material risks and dangers inherently and
19   potentially involved with respect to the
20   proposed therapy, if any, you cannot comment
21   one way or the other on that?  You're taking
22   his word, correct?
23         A.       Well, those are two different
24   questions.  You asked me about the law.  And
25   then at the end, you asked me about him, what
0077
 1   he did.
 2                  I already said I'm not accusing
 3   anybody of any deception.  I do want to say
 4   that, as written, that statute doesn't seem to
 5   me to do what I think informed consent
 6   requires, which is a signed consent form by the
 7   patient.  And I base that on 30 years of work
 8   in this area.
 9         Q.       So you've already told me you
10   have no specific problem with David Burkhardt.
11   Your problem more is with the way Ohio law is
12   written as far as the requirements for informed
13   consent?
14         A.       Ohio law as written and perhaps
15   as Ohio law as interpreted.
16         Q.       Now, in looking at this case --
17   and I'm going to object again to this because
18   your opinions essentially are as a layperson
19   here, but just to go forward with this -- there
20   is obviously evidence in the materials that
21   you've reviewed here that Mr. Sullivan was
22   aware that there were risks to this procedure,
23   correct?
24                  MR. KULWICKI:  Objection.
25                  You can answer.
0078
 1         A.       Would you like to give me some
 2   examples?  I just -- that's a very broad
 3   statement.
 4   BY MS. CARULAS:
 5         Q.       Sure.  Before I go into the
 6   examples.
 7                  Are you aware of anything, in
 8   all the materials you looked at here, that
 9   Mr. Sullivan was aware that there were risks to
10   this procedure?
11                  MR. KULWICKI:  Well, you know, I
12         object because to ask what he was aware
13         of, you're asking him to convey what his
14         state of mind is.  I mean, you can ask if
15         he's aware of testimony.
16                  I just don't think that's an
17         appropriate question.  I think that's a
18         very deceptive question.  I think there's
19         a fair way you can ask it, though.
20                  I mean, obviously, we all know
21         Burkhardt testified that he told him.
22         You can ask that.  I mean, that's
23         obvious.
24                  But to ask him what Sullivan
25         knew or what he was aware of, I don't
0079
 1         know how he can -- that's just . . .
 2         A.       The problem is the word
 3   awareness is so vexed.  I could ask you if
 4   you're aware of the wall behind you at this
 5   moment.  No, not until I called your attention
 6   to it.
 7                  I mean, the sense of awareness
 8   is really complex.
 9   BY MS. CARULAS:
10         Q.       Besides the documentation by
11   Dr. Burkhardt -- we have the documentation that
12   he advised Mr. Sullivan of the risks of the
13   procedure, correct?
14         A.       We have his documentation that
15   he says that he did that.
16         Q.       And you have read his deposition
17   where he testified that he did, indeed, as
18   documented in the note, have a detailed
19   discussion with Mr. Sullivan and that, in
20   particular, he told him there was a risk of
21   stroke to this procedure.
22                  Did you read that?
23         A.       That is -- I read it.  And as I
24   recall, that's what was in his testimony.
25         Q.       Again, you have no reason to
0080
 1   question his integrity in his testimony?
 2         A.       I do not.
 3         Q.       Besides that documentation that
 4   Mr. Sullivan was told there are risks to the
 5   procedure, are you aware of any other
 6   documentation in this case that would be some
 7   evidence that Mr. Sullivan was told about
 8   risks?
 9         A.       Well, I recall that there are
10   other people who claimed, perhaps in the second
11   person, that they were aware that -- or that
12   they believed that Mr. Sullivan was told of the
13   risks.
14                  So there are numbers of
15   statements that assert that he was aware of
16   risks, had some sense of awareness.
17         Q.       Right.  We saw, and I went
18   through it a little bit ago, that there is a
19   Web site that Mr. Sullivan looked at, that
20   although it does not list out details, it does
21   say something to the effect, as with all
22   procedures, there are risks associated with
23   that.
24                  You saw that, correct?
25         A.       I did see that.  I hope you're
0081
 1   not suggesting that Cleveland Clinic is -- is
 2   relying on a Web site, since we know what the
 3   Web is like in this case.
 4         Q.       Right, no.  And I don't think
 5   anyone, any reasonable person, whether it's a
 6   patient or a physician, can necessarily rely on
 7   the Web.
 8                  Would you agree with that?
 9                  MR. KULWICKI:  Objection.
10         A.       Well, the problem is that if the
11   site is a representation by the organization,
12   then it would be reasonable for anybody to take
13   it as a statement that was made by the
14   organization.
15   BY MS. CARULAS:
16         Q.       So it's certainly not the
17   informed consent discussion.  That is, the
18   informed consent is a process between a
19   physician and a patient?
20                  MR. KULWICKI:  Objection.
21         Compound question.
22         A.       So --
23   BY MS. CARULAS:
24         Q.       Let me start over.  I want to
25   just keep this focused, if we can.  Otherwise,
0082
 1   we'll be here all day, and I have a plane to
 2   catch.
 3                  MR. KULWICKI:  Anna, you haven't
 4         asked him a single question about his
 5         opinions.  I mean, you're so bent on
 6         trying to ask everything but what a
 7         medical ethicist does in this case and
 8         what hospital standards of care are and
 9         whether Ohio law requires hospitals to
10         follow hospital standards of care.  You
11         have completely missed the applicability
12         of his testimony.
13                  MS. CARULAS:  I'll get to it.
14         Trust me, I'll get to it.
15                  MR. KULWICKI:  Yes.  I mean,
16         it's just you haven't asked a single
17         question so far that goes to this
18         expert's credentials to testify as an
19         expert in this case or as to his opinions
20         in this case.  We've been here for two
21         hours.
22                  MS. CARULAS:  I respectfully
23         disagree.  But that is a point of
24         discussion later.  Okay?
25                  Let me go on.
0083
 1   BY MS. CARULAS:
 2         Q.       So as far as evidence in the
 3   file that he was told about risks or that there
 4   was something out there aware of risks --
 5                  MR. KULWICKI:  Let me have an
 6         objection to this line of questioning,
 7         because this expert isn't here to define
 8         who is telling the truth and who is not
 9         tell the truth.  And he is not here to
10         give medical opinions whatsoever.
11                  He's here to testify about
12         hospital standards of care as a medical
13         ethicist, period.
14                  MS. CARULAS:  You may have an
15         objection.  Noted.
16   BY MS. CARULAS:
17         Q.       So we know there's mention on
18   the Web site of risks, correct?
19         A.       Yes.
20         Q.       Did you see documentation in any
21   of the Hawaii physician records that
22   Mr. Sullivan was told about risks, that there
23   are risks to this procedure?
24         A.       I would have to look at them
25   again.  I was struck that some of the
0084
 1   statements about risks seemed to be a little
 2   different in Hawaii than they were in Ohio, the
 3   levels of risk, the nature of the procedure.
 4   There seemed to me to be some variance there
 5   that would concern me, if we ever could talk
 6   about that.
 7         Q.       What was that?
 8         A.       Well, if -- if you were giving
 9   me a case like this in a conference in a
10   medical school, and you would describe it, the
11   idea that he would have been -- information
12   would have been provided to him in Hawaii that
13   didn't look to me like the same information
14   that he got in Cleveland and then he flies to
15   Cleveland, obviously, in a vulnerable
16   condition, emotionally vulnerable as well as
17   medically involved, I would have to say that I
18   have real worries, I have great worries about
19   the extent to which he was able to make a fully
20   voluntary decision about whether to have this
21   procedure under the circumstances.
22                  This is what worried me about
23   the use of the word "awareness," because our
24   awareness -- one of the things that worried me
25   before is, our awareness is so compromised by
0085
 1   fear when we're sick.
 2                  And so how he actually
 3   integrated information, did he have enough
 4   time, was there -- was there a comfortable
 5   situation which he could reflect on whether he
 6   wanted to go ahead, I don't see that here.
 7                  And that goes to the core of my
 8   views about this case based on the information
 9   that I had.
10         Q.       Tell me -- and we're going to
11   get to the other evidence in the chart that he
12   was aware of risks -- but tell me, what is it
13   in the prior Hawaii records that concerned you
14   or worried you about his awareness?
15                  And, again, I object to the
16   whole nature of it.  But go ahead.
17         A.       Right.  So I'm not commenting on
18   the awareness question.
19                  You have a serious illness and
20   you're on one side of the planet.  And
21   you're -- the notion is that you're going to go
22   somewhere very far away in the hopes of having
23   some kind of beneficial intervention, those
24   folks in the original site need to give you all
25   of the same quality of information that you
0086
 1   would get when you're making that emotional
 2   commitment to go to that other place.
 3                  And I -- the idea of the nature
 4   of the procedure, I believe it was given a
 5   different name in Hawaii.  The risks, I saw
 6   different levels of risks cited in Hawaii and
 7   then apparently on site.  It was very hard to
 8   tell.
 9                  This is -- this was a --
10         Q.       Show me.  I want to know the
11   specifics.  Where is it that the name of the
12   procedure was different and where the risks
13   were described as different?
14         A.       I'd have to go back and look at
15   the documents.
16                  (Pause)
17         Q.       I'll help you.  These are the
18   Hawaiian records over here.
19         A.       I wasn't sure.  Like Hawaii and
20   Ohio, they're in two different places.  I'm
21   looking for the report of the conversation that
22   he had.
23                  (Pause)
24                  I have to go back and find the
25   description.
0087
 1                  (Pause)
 2                  Dr. Shen uses the term,
 3   "curative ablation."  I'm really concerned
 4   about the word "curative," but . . .
 5         Q.       What is Dr. Shen's specialty, do
 6   you know?
 7         A.       I gather he's a cardiologist.
 8         Q.       Do you know if he had any
 9   subspecialty?
10         A.       I guess it was interventional
11   cardiology.
12         Q.       He's an electrophysiologist?
13         A.       I take that he was an
14   electrophysiologist.
15         Q.       Do you know the difference
16   between an electrophysiologist and an
17   interventional cardiologist?
18         A.       So, in general,
19   electrophysiologists use devices that involve
20   giving electrical impulses to an organ.
21         Q.       From a layperson's perspective,
22   you know that there is a big difference in
23   subspecialties between an interventional
24   cardiologist and an electrophysiologist,
25   correct?
0088
 1                  MR. KULWICKI:  Objection.
 2         A.       Well, there's a little -- I'll
 3   take your word for it.  There's a little
 4   overlap.
 5   BY MS. CARULAS:
 6         Q.       They're both cardiologists, but
 7   then --
 8         A.       Some people do both, as far as I
 9   know.  But there are cardiologists who do
10   electrophysiology interventions, right.
11         Q.       You know that they have
12   separate --
13         A.       Boards.
14         Q.       -- fellowship training and
15   separate boards, correct?
16         A.       Yes.  I'm looking for a
17   particular letter.  Sorry to take this time.
18         Q.       Just the record should reflect
19   that I'm allowing you time to -- I don't know
20   how long it's been now, five to ten minutes.
21   Your looking through the documents to find --
22   you said that you thought there was --
23         A.       I recall that there was a
24   description of the procedure that looked
25   different to me.
0089
 1                  But, you know, I'm not here as a
 2   medical expert.  So it wasn't something that I
 3   focused on.
 4         Q.       So you cannot comment --
 5         A.       I'm sorry.
 6         Q.       You cannot comment that there
 7   was some difference or trouble between what was
 8   described to him by his
 9   cardiologist/electrophysiologist in Hawaii and
10   what was described to him in Cleveland?
11         A.       My recollection is, it was
12   different.  But I'm looking through the
13   documents now.  It's not something that I
14   focused on when I was reading the documents.
15   It's something I recall that's come up in
16   conversation with us.
17         Q.       Again, because you are a
18   layperson in this medical realm, you would
19   defer to the electrophysiologist to discuss
20   this issue of the nature of the procedure and
21   how it's described --
22         A.       Yes.
23         Q.       -- fair?
24         A.       Yes.
25         Q.       All right.  Let go back, if we
0090
 1   can, to my question about whether or not there
 2   was some discussion as far as risks.
 3                  Are you aware that Dr. Hong
 4   described that he discussed, "The potential
 5   risks and complications were reviewed in detail
 6   with Mr. Sullivan"?
 7                  Do you recall seeing that?
 8         A.       That's what he said.
 9                  MR. KULWICKI:  Objection.
10   BY MS. CARULAS:
11         Q.       And then we've talked about the
12   discussion with Dr. Burkhardt.
13                  Are you aware whether or not any
14   other individuals at the Cleveland Clinic
15   discussed the nature of the procedure and the
16   potential risks of the procedure, and, in
17   particular, the risk of stroke, with
18   Mr. Sullivan?
19                  MR. KULWICKI:  Are you asking if
20         he has personal knowledge or if he
21         reviewed their testimony claiming that
22         they had that conversation?
23         A.       I'm aware that there are people
24   who said that they had had those discussions.
25   BY MS. CARULAS:
0091
 1         Q.       Who in particular are you aware
 2   of based on the evidence in this case?
 3         A.       I believe Nurse Poe referred to
 4   a couple of people who had had that -- those
 5   discussions.  Was it Burkhardt and -- I can't
 6   remember if it was Kanj, who she claimed had
 7   those discussions.
 8         Q.       Do you recall that Stacy Poe
 9   testified that she herself describes the nature
10   of the procedure and gives a handout with risks
11   written on the side specifically to the
12   patient?
13                  Do you recall that testimony?
14         A.       I recall that she said she did
15   that and that she was doing a reconstruction
16   from memory of that document.  I don't know
17   that I ever saw that original document.
18         Q.       And then you recall Dr. Kanj's
19   testimony as well, that he reiterated, and also
20   on the morning of the procedure made sure, that
21   the patient had been consented by Dr. Burkhardt
22   and then also mentioned that there are risks,
23   including the risk of stroke, correct?
24         A.       That's what he testified.
25         Q.       Again, I know you're not a
0092
 1   medical professional, but as a layperson, if
 2   you're permitted to give testimony in this
 3   case, would you agree that most people realize
 4   that with any surgery, there are risks?
 5                  MR. KULWICKI:  Objection.
 6         A.       I guess the word "realize," like
 7   the word "awareness," is pretty loaded.
 8                  When people are in a position of
 9   badly needing intervention, they do tend to
10   turn down the volume on risks.
11                  And, therefore, it's
12   particularly important that it be made very
13   clear to them in writing, something that they
14   have to commit themselves to in writing, that
15   they are aware of those risks; that they have
16   taken those risks into their decision.
17   BY MS. CARULAS:
18         Q.       So it is not unusual for
19   patients -- I mean, whether they are given the
20   risks in detail verbally or even in a piece of
21   paper, the tendency is to turn down the volume,
22   because nobody ever wants to think that that
23   risk will happen to them?
24                  MR. KULWICKI:  Objection.
25   BY MS. CARULAS:
0093
 1         Q.       Is that fair?
 2                  MR. KULWICKI:  Objection.
 3         A.       That's -- that's exactly why
 4   written consent forms are required, because it
 5   helps to ensure that, in fact, what has been
 6   said has been reduced to writing in a way that
 7   the patient can see.
 8                  And the fact that a signed form
 9   is not present in this case fails to satisfy a
10   very well-established standard that requires
11   that kind of level of patient commitment to --
12   with a signature -- to ensure that level of
13   awareness.
14         Q.       You, I'm sure -- and, again, I
15   object to you giving opinions on this
16   necessarily, but just so we have that all out
17   there -- you would agree that patients, in
18   regular practice, do sign consent forms that
19   they, quote, unquote, turn the volume down or
20   simply sign as well, true?
21         A.       You know, it is true that
22   patients have a way of telling themselves that
23   they're going to accrue benefits that they
24   might not.  That's why it is so important for
25   the consent process to be thorough, for it not
0094
 1   to require any emotional commitment on the part
 2   of the patient to going ahead with the
 3   procedure.
 4                  We left the topic of the travel
 5   of this patient to Ohio.  I think that is quite
 6   important.
 7                  So while it is -- the moral
 8   burden on the institution and the doctors is
 9   grave.  And that involves ensuring that the
10   patient has the fullest freedom to decline to
11   go further.  And that is very hard to guarantee
12   when the circumstances are as were the case for
13   Mr. Sullivan.
14         Q.       Well, one can never guarantee
15   what you are saying as far as ensuring the
16   ultimate --
17         A.       There are --
18                  MR. KULWICKI:  Wait.  Objection.
19                  Go ahead.
20         A.       (Continuing)  You have to be
21   very careful of slippage here.
22                  To say that there is no
23   guarantee, while in one sense it is true, in
24   another sense it can give license to being
25   pretty sloppy and to putting people in a
0095
 1   position where a reasonable person would have a
 2   hard time sorting out risks and benefits, as I
 3   think is the case in the scenario here.
 4   BY MS. CARULAS:
 5         Q.       Let's go back.  We know that
 6   Mr. Sullivan met with three different
 7   cardiologists in Hawaii and then contacted the
 8   Cleveland Clinic, correct?
 9         A.       That's what the record shows.
10         Q.       And you are aware that it was
11   Dr. Burkhardt's judgment, he documented that
12   this could be treated as a one tripper?  Did
13   you see that in the notes?
14         A.       I saw that phrase.
15         Q.       We've already been through all
16   of this.  You are not commenting on the medical
17   judgments of Dr. Burkhardt, correct?
18         A.       I'm not commenting on his
19   medical judgments, no.
20         Q.       Now, let me just go back, if I
21   can.  And I understand you loud and clear that
22   you think there should be a written consent
23   form.  And we've been through --
24         A.       A signed consent form.
25         Q.       A signed, okay.
0096
 1         A.       Not that I think.  But may I
 2   say, this was the -- this was the standard at
 3   the time in the field of medical ethics.  And
 4   this has been established for a very long time
 5   before this period.
 6         Q.       Where is that codified?
 7         A.       Well, there are no organizations
 8   that say that.  But I would refer you to the
 9   medical ethics literature that talk about
10   signed consent forms.  And it's all over the
11   literature.
12                  That's not a substitute for the
13   process.  And you stated that -- you mentioned
14   the fact that informed consent is a process.
15         Q.       Right.
16         A.       But it is a critical -- I would
17   say there is absolutely conventional -- anybody
18   in medical ethics would have told you that you
19   need to get a signed consent form for a
20   procedure like this.
21         Q.       All right.  But, again, the
22   process, when you're talking about the process,
23   that is a process between the patient --
24         A.       The form --
25         Q.       Wait until I finish.
0097
 1         A.       I'm sorry.
 2         Q.       When you talk about a process,
 3   you are talking about the process between the
 4   physician performing the procedure and the
 5   patient, correct?
 6         A.       That's correct.
 7         Q.       All right.  So I understand,
 8   we've talked about Ohio law and your opinion on
 9   that.
10                  You've said there is no
11   organization that specifically said you need a
12   written consent form.
13                  Your basis for this is the
14   medical ethics literature, correct?
15         A.       Correct.
16         Q.       Do you know a medical ethicist
17   by the name of Paterick, P-a-t-e-r-i-c-k?
18         A.       No.
19         Q.       Would you agree with the
20   statement that the dialogue between patient and
21   physician is the essence of the informed
22   consent process?
23         A.       I'd agree with that, as
24   memorialized in the consent form.
25         Q.       So the memorialization in the
0098
 1   consent form -- okay.
 2                  You would agree with the general
 3   statement that the essence is the dialogue
 4   between the physician and the patient?
 5         A.       Yes.
 6         Q.       You would agree that the
 7   quantity and the specificity of the information
 8   in that discussion should be tailored to meet
 9   the preferences and the need of that individual
10   patient?
11         A.       If circumstances require
12   tailoring, then it should be tailored.
13         Q.       Now, would you agree with the
14   statement that informed consent is not a piece
15   of paper.  It is a trust between physician and
16   patient, and to ignore that could leave you in
17   a heap of trouble?
18         A.       I agree with the statement as
19   far as it goes.  But it's not because of the
20   trouble for the doctor.  It's because of the
21   failure to respect the patient.
22         Q.       Right.  But you would agree that
23   informed consent is not a piece of paper?
24         A.       That -- that's -- the informed
25   consent form is a required memorialization of
0099
 1   the informed consent process.  It is part of
 2   the process.
 3                  And I would say that there's
 4   powerful psychological reasons to make that
 5   part of the process.
 6                  None of the statements I've
 7   heard so far say that you don't need a consent
 8   form as part of the process.
 9         Q.       Right.  We've been through Ohio
10   law.
11         A.       Well, I'm not -- again, I can't
12   interpret Ohio law.  And if you present me Ohio
13   law in an ethics paper, I would have to say,
14   well, I'm interested in the ethics, not the
15   law.
16         Q.       Again, I think you have touched
17   on this.  But you would agree that just because
18   there is a signed consent form by a patient
19   doesn't mean there was informed consent?
20         A.       A signed consent form is a
21   necessary, but not sufficient condition of
22   informed consent.
23         Q.       I understand your opinion, that
24   you think it's a necessary component.
25                  But just having --
0100
 1         A.       I'm telling you what the field
 2   believes.  The position of the field is, in
 3   medical ethics, that it is a necessary, but not
 4   sufficient condition.
 5         Q.       Do you know, sir, whether back
 6   in 2006, there were any other institutions, any
 7   other leading institutions across the country,
 8   other than the Cleveland Clinic, who did not
 9   use consent forms?
10         A.       I would say if there were such
11   institutions, that that's worth a paper in a
12   scholarly journal, because that suggests
13   that -- that there have been serious failures
14   of medical ethics at major institutions.
15         Q.       My question to you is, as to
16   what was --
17         A.       I don't have personal knowledge.
18         Q.       You've got to wait until I
19   finish.
20         A.       Sorry.
21         Q.       That's all right.
22                  Do you have any personal
23   knowledge whether any other leading
24   institutions across the United States did not
25   utilize written consent forms for their consent
0101
 1   process in 2006?
 2         A.       No.  And that wouldn't affect my
 3   position on the ethics.
 4         Q.       But the answer is, no, you don't
 5   know?
 6         A.       No, I don't know.  And it
 7   wouldn't affect my position on the ethics
 8   question.
 9         Q.       All right.
10         A.       Can I do a little history here?
11   There's a good reason that we reached this
12   position in the field that I'm describing to
13   you.  And that is, 2,000 years of physician
14   discretion about what happens between them and
15   their patients.
16                  I'm not saying that anybody did
17   anything inappropriate in this case, or that
18   anybody is misrepresenting what they said or
19   believe they said.
20                  But what I'm saying is, there
21   were very good reasons to require a written
22   consent formed signed by a patient.
23         Q.       And you're not saying that if
24   there was evidence of a written consent form
25   signed by Mr. Sullivan, that that would have
0102
 1   changed this course or outcome at all?
 2                  MR. KULWICKI:  Objection.
 3   BY MS. CARULAS:
 4         Q.       I mean, you're --
 5         A.       I have no way of speculating on
 6   that counterfactual.
 7         Q.       Have there ever, to your
 8   knowledge, been any studies on that subject of
 9   whether or not a written consent form has
10   altered the course?
11         A.       Well, it's difficult to run a
12   study like that because you're trying to
13   control for an alternative universe.
14                  People have been very interested
15   in running studies like that.  I don't know
16   that anybody has ever been able to design one
17   that would get the answer that one would be
18   looking for.
19                  The reason to require a signed
20   consent form is not only that it might change
21   the course of treatment, but as a measure of
22   respect for the patient.
23         Q.       Right.  And I understand your
24   position.
25                  You're not saying that at any
0103
 1   time during the course of this interaction,
 2   that Dr. Burkhardt or Stacy Poe or Dr. Kanj or
 3   any of the folks at the Cleveland Clinic did
 4   not have respect for Shannon Sullivan?
 5         A.       Oh, I'm sure that they respected
 6   Shannon Sullivan.  I'm certainly not calling
 7   into question their personal morality or their
 8   professional ethics.
 9                  The field has come around to a
10   standard of what counts as respect for the
11   patient with respect to informed consent.
12                  And because of a history of
13   excessive physician discretion and a lot of
14   other factors as well, a signed consent form is
15   regarded as a necessary part of the process.
16         Q.       I understand that's your
17   opinion.
18         A.       Yes.
19         Q.       You are giving your opinion here
20   as a medical ethicist, true?
21         A.       Yes, ma'am.
22         Q.       Or as a philosopher, correct?
23         A.       I'm giving my opinion based on
24   30-plus years working in the field of medical
25   ethics.
0104
 1         Q.       And philosophy?
 2         A.       And philosophy and history of
 3   medicine.
 4         Q.       Okay.  The opinion you are
 5   giving here, it's your personal opinion, it
 6   does not have the sanction of the University of
 7   Pennsylvania, per se?
 8         A.       No.
 9         Q.       As far as the compensation that
10   you're receiving from Mr. Kulwicki in this case
11   and that I will pay you for your time to learn
12   your opinions here today, do you keep that
13   personally or does it go to the University of
14   Pennsylvania?
15         A.       Because we're using a room that
16   is at the University of Pennsylvania, I will
17   write that -- the check over to the University
18   of Pennsylvania for this deposition.
19         Q.       So the deposition will go to the
20   university.  But as far as --
21         A.       Will go to an account in the
22   Department of Medical Ethics.
23         Q.       All right.  The rest of the fees
24   that you earn from Mr. Kulwicki, from your
25   review and report and so forth, that's money
0105
 1   you kept?
 2         A.       That's correct.
 3         Q.       Do you have a fee schedule or
 4   no?
 5         A.       $300 an hour.
 6         Q.       Across the board, basically?
 7         A.       Yes.
 8         Q.       Are you aware of any studies
 9   that have looked into what percentage of
10   patients actually read consent forms and digest
11   it or have awareness of it?
12         A.       Yes.  There are -- there are a
13   number of studies.  Some studies indicate that
14   people don't read them right away, that they
15   read them later on.  That they pull them out of
16   their purse or a briefcase and share them with
17   a relative.
18                  People are all over the map in
19   terms of how they use consent forms.
20                  But, again, the consequences of
21   the role of a consent form are not even the
22   principal issue for me.
23         Q.       I mean, the bottom line to you,
24   you just think that as a matter of medical
25   ethics in respect to the patient, they should
0106
 1   be given something in writing?
 2         A.       They should be asked to sign a
 3   consent form.
 4         Q.       Again, I think as far as what
 5   would be in the consent form -- and we touched
 6   upon this earlier -- you would agree it can be
 7   a subject of -- I don't like the word
 8   "debate" -- but a subject of discussion and --
 9         A.       And --
10         Q.       -- negotiation or dialogue.
11   There can be differences of opinions as to how
12   much should be in the form, how detailed or
13   general it should be?
14         A.       There are often such
15   discussions.
16         Q.       As to what the procedure is,
17   when it should be given to the patient and by
18   whom, that could be a subject of discussion as
19   well?
20                  MR. KULWICKI:  Objection.
21         A.       This could -- could be a subject
22   of discussion among whom?  I'm sorry.  Who is
23   talking about it in the way that you're setting
24   it up?
25   BY MS. CARULAS:
0107
 1         Q.       Well, I guess that's a question.
 2                  Amongst medical ethicists, is
 3   that something that could be discussed and have
 4   different opinions on the subject?
 5         A.       I don't think that there's
 6   anybody in medical ethics who wouldn't agree
 7   that the -- that the person who is going to do
 8   the procedure, the people who are directly
 9   involved in the case, bear the responsibility,
10   primary responsibility.
11                  People who are referring also
12   bear a responsibility to be accurate and
13   complete in their information that they provide
14   to the patient.
15         Q.       Okay.  So the people really
16   responsible for getting informed consent, in
17   your opinion, are the referring physicians,
18   they should have a dialogue, and then the
19   primary responsible physician?
20                  MR. KULWICKI:  Objection.
21   BY MS. CARULAS:
22         Q.       I mean, we've been through this
23   before.
24         A.       Yeah.  I'm just -- I'm afraid
25   that the particular conditions under which
0108
 1   Mr. Sullivan went to Ohio are getting washed
 2   out in this exchange between us.
 3                  And so I do want to stipulate,
 4   but I believe that there's the outstanding
 5   issue about the way that he traveled for the
 6   one tripper to the clinic.  And the -- and the
 7   burden that that placed on the consent process
 8   and the -- and the possibility, which can I
 9   think is a very serious one here, that he would
10   have felt emotionally committed to proceeding.
11   And that his awareness, as you put it, of the
12   risks and benefits might have been compromised
13   in a situation like that.
14                  If you were to ask me, do I know
15   that for a fact?  I would say no.  I'm
16   commenting as if he were presenting the
17   scenario to me in a case conference.
18         Q.       Okay.  So you're saying the
19   potential or the possibility exists of this
20   feeling of being too committed to the procedure
21   or this decreased awareness?
22                  MR. KULWICKI:  Objection.
23         A.       Considering the vulnerability of
24   somebody in his situation, I believe it is a --
25   and I believe that my colleagues would agree,
0109
 1   that this places a big burden on the consent
 2   process.  And that it is hard for somebody in
 3   that kind of situation to see matters as
 4   clearly as he might if he hadn't made the trip
 5   and made the emotional commitment to being
 6   there.
 7   BY MS. CARULAS:
 8         Q.       Well, you would agree that when
 9   someone gets on a plane and -- I mean, first of
10   all, you know that Shannon Sullivan did a
11   significant amount of research about this
12   beforehand?  You saw that?
13                  MR. KULWICKI:  Objection.
14                  You can answer.
15         A.       I'm not sure what "significant
16   amount of research" means.  Maybe you could
17   tell me what you think that means.
18   BY MS. CARULAS:
19         Q.       Yes.  Are you aware that he
20   became educated on the procedure itself?
21                  MR. KULWICKI:  Objection.
22         A.       There -- there is so much stuff
23   out there, especially now because of the Web,
24   that I'd be very uncomfortable with the notion
25   that somebody could self-educate in a situation
0110
 1   like this.
 2   BY MS. CARULAS:
 3         Q.       You're aware that he met with a
 4   number of different cardiologists?
 5         A.       Yes.
 6         Q.       And specifically
 7   electrophysiologists who discussed the
 8   procedure with him?
 9                  MR. KULWICKI:  Objection.
10         That's a gross misrepresentation of the
11         facts.
12                  You don't know that.  You don't
13         know what they say.  You know what they
14         documented, but you don't have a clue
15         what they said.  And in fact, they
16         documented that they were discussing the
17         Maze procedure.
18                  So a completely different
19         procedure, Anna.  So you're grossly
20         misrepresenting the facts to this
21         witness.
22                  MS. CARULAS:  I move to strike.
23         That's absolutely not true.  And if
24         anyone looks at the records, it's pretty
25         darn obvious.
0111
 1                  But we have here about another
 2         hour to get going.  So you can argue your
 3         perspective on this as long as you want
 4         at a later time.
 5   BY MS. CARULAS:
 6         Q.       You are aware that he had
 7   discussions with three different cardiologists,
 8   two of whom are electrophysiologists, correct?
 9         A.       I'm aware he had discussions.
10         Q.       And you would agree that getting
11   on a plane and coming to Cleveland for a
12   procedure shows -- or do you know, does it
13   show a level of commitment to wanting the
14   procedure?
15         A.       It shows a level of commitment
16   to being made better.
17         Q.       Yes.
18         A.       And that's perfectly
19   understandable.  And I would feel exactly the
20   same way.  I'd want to be made better.
21         Q.       Okay.
22         A.       And wanting to be made better is
23   such an overwhelming emotion when you're ill,
24   that it's so critical not to set up a situation
25   in which that further compromises what is
0112
 1   already a hard decision for somebody who's
 2   sick.
 3                  This almost strikes me, frankly,
 4   as -- it reminds me of the kind of medical
 5   tourism that's going on now from one part of
 6   the globe to another.
 7                  So it's a -- it puts a terrific
 8   burden on our ethical standards to have people
 9   moving around in this way when they're sick.
10         Q.       All right.  But I understand
11   your concern from a medical ethicist.  And you
12   have expressed that, correct?
13         A.       That's why I'm here, as a
14   medical ethicist.
15         Q.       And we've been through whose
16   judgment this was and so forth.  Okay, I
17   understand your statement.
18                  So if you pull out your report,
19   I just want to go through some of the things
20   you've said here.
21         A.       Sure.
22         Q.       So number one, you talk about
23   the conventions and standards of medical
24   ethics.  And you make the statement as far as
25   the need for an informed consent, correct?
0113
 1         A.       Yes.
 2         Q.       Again, we've talked about what
 3   are the bases for that, and we talked about how
 4   essentially the support for this is the
 5   literature on medical ethics that we talked
 6   about, correct?
 7         A.       Yes.
 8         Q.       Then number two, you say that
 9   the conventions and standards of medical ethics
10   provide that this be reduced in writing, which
11   we've discussed --
12         A.       Right.
13         Q.       -- correct?
14         A.       Yes.
15         Q.       And, again, the basis of this
16   what you have, quote, unquote, conventions and
17   standards of medical ethics is, as we
18   discussed, the medical ethics literature?
19         A.       Yes.
20         Q.       Now, number three, you say that,
21   "The ethical justification for the reduction of
22   informed consent to writing is that of
23   protecting and promoting the patient's right to
24   self-determination."
25         A.       Yes.
0114
 1         Q.       What do you mean by "ethical
 2   justification"?
 3         A.       I mean to distinguish it from
 4   any legal requirement.
 5                  I'm not a lawyer, as we've
 6   firmly established.  So I'm not saying that
 7   it's a legal -- I don't know if, in this
 8   instance, it's a legal problem or not.
 9         Q.       Then you go on and say, "In
10   practical terms, a patient may not be able to
11   focus on verbal exchange due to the stress and
12   anxiety of illness"?
13         A.       Uh-hum, as we discussed.
14         Q.       We discussed that.  As far as
15   being able to say it was a fact in this case
16   that Mr. Sullivan was not able to focus on a
17   verbal exchange due to stress and anxiety of
18   illness, you cannot say that.  You're just
19   giving a general statement, correct?
20                  MR. KULWICKI:  Objection.
21         A.       I am saying that a person in
22   this position would have a very hard time not
23   being influenced by the stress and anxiety of
24   their medical situation and -- well, I'll leave
25   it at that.
0115
 1   BY MS. CARULAS:
 2         Q.       All right.  But my question to
 3   you -- you're talking general -- you are not
 4   able to say that Mr. Sullivan personally was
 5   not able to focus on the verbal exchange due to
 6   stress and anxiety, true?
 7         A.       That's right.  And that's not
 8   what I say here.
 9         Q.       We're on the same page --
10         A.       Right.
11         Q.       -- correct?  Is that true, we're
12   on the same page?  Am I understanding you?
13         A.       I believe that what you just
14   said is accurate.  I did not interview
15   Mr. Sullivan.  I do not have personal knowledge
16   of his psychologic condition at that time.
17         Q.       It then goes on and says that
18   the patient "may be cognitively or otherwise
19   impaired in ways that are not obvious but make
20   processing the information difficult."
21                  As you've looked at his medical
22   records prior to the point of going to the
23   Cleveland Clinic, are you aware that
24   Mr. Sullivan, at the time he came to the
25   Cleveland Clinic, August 16th, August 17th,
0116
 1   2006, was cognitively impaired?
 2         A.       I have no specific evidence to
 3   show that he was cognitively impaired or
 4   emotionally impaired.
 5         Q.       Then it says he may not be a
 6   native English speaker.
 7                  We know that he was a native
 8   English speaker?
 9         A.       Fine.
10         Q.       Now, the whole point of informed
11   consent is that the patient understands the
12   risks, correct?
13         A.       And understands them and
14   appreciates, which is taking them on board in a
15   way that lines up with their preferences and
16   values.
17         Q.       I mean, that's the bottom line
18   to it, correct?
19         A.       That's one bottom line.
20         Q.       I mean, that's the goal?  The
21   goal is, you want the --
22         A.       The goal is to make --
23         Q.       Wait, wait.  Let me finish.
24                  The goal is, at the end of an
25   informed consent discussion, that the patient
0117
 1   understands the nature of the procedure, the
 2   potential risks and the benefits --
 3         A.       And --
 4         Q.       -- and makes an informed
 5   decision?
 6         A.       And to that list, I'd add and
 7   the alternatives.
 8         Q.       And the alternatives, okay.
 9         A.       And to emphasize again, that his
10   self-determination is respected and promoted.
11         Q.       And we've been through all of
12   that.
13                  And you go on to say those above
14   things that we can't say were present in
15   Mr. Sullivan, that he wasn't an English
16   speaker, et cetera, all of these are obstacles
17   to self-determination that are at least partly
18   ameliorated by a consent form; is that correct?
19         A.       Right.
20         Q.       Now, there are circumstances
21   where a written consent form is not even going
22   to help at all in a patient's
23   self-determination in understanding the risks?
24         A.       I'm not sure what circumstances
25   you're referring to.
0118
 1         Q.       Well, can you think of any
 2   circumstances where a written form is not going
 3   to partly help the process?
 4         A.       Well, in an emergency, it's
 5   waived.  You get what you can later on.  If
 6   somebody is too young or has a dementia or is
 7   otherwise unable to participate in the process,
 8   then there has to be a surrogate
 9   decision-maker.
10         Q.       If the patient is illiterate?
11         A.       No.  Literacy is not a
12   condition.  They can be explained verbally.  So
13   the fact that somebody is illiterate or is not
14   an English speaker -- or a speaker of the
15   current language should not be an issue.
16         Q.       In the case of a patient who is
17   illiterate, is an informed consent discussion
18   an alternative, a viable alternative, a verbal
19   discussion?
20         A.       In the case of somebody who is
21   illiterate, we still ask them, at the very
22   least, to make a mark that will indicate that
23   they have been a participant in a discussion.
24         Q.       And the point of that is for the
25   evidence of it essentially?
0119
 1         A.       Well, no.  It's more than that
 2   time.  It's not a legal question for me.
 3         Q.       All right.  Number four, you
 4   say, "The only evidence of informed consent I
 5   have seen is a signed statement by the
 6   physician that such consent was obtained."
 7         A.       Yes.
 8         Q.       We've since gone through at
 9   least a list of other evidence, as one would
10   look at the facts of the case, of discussions
11   of the risks, true?
12         A.       You know, they -- I believe that
13   people believe that they did those things.  But
14   for me, it really needs to be a signed consent
15   form.  And that is the view in the field.
16         Q.       Of medical ethics?
17         A.       Yes.
18         Q.       Then you're going through and
19   say, the act of signing a consent form should
20   also be witnessed by a third party.
21                  Do you believe the third party
22   needs to sign it?
23         A.       Normally, that is the
24   expectation.
25         Q.       You're not here to talk about
0120
 1   whether the law requires a third party
 2   signature.
 3                  Do you believe that the
 4   conventions of medical ethics require a
 5   third-party signature?
 6         A.       I would say that's a little
 7   weaker.  It is a preference.  But it's not the
 8   kind of requirement that I would say a signed
 9   consent for a patient is.  And that's partly
10   because of this complication that the patient
11   may not have capacity, and, therefore, the
12   surrogate would have to give consent,
13   permission.
14         Q.       All right.  Then you're saying
15   you think, number six, they should get the copy
16   to take with them?
17         A.       Yes.
18         Q.       All right.  Then number seven,
19   you say that a signed consent form, in your
20   opinion, is necessary, but not a sufficient
21   condition.
22                  And we've been through that
23   before.  You need to have the discussion?
24         A.       Yes, ma'am.
25         Q.       And you go on and say precisely
0121
 1   that, that it's a process.  It's not a discrete
 2   piece of paper or event?
 3         A.       Well, it's not -- it is a
 4   discrete piece of paper.  It is not a discrete
 5   event.
 6                  Particularly, in a situation,
 7   what I gather, has involved a period of time
 8   and changes in his condition.  So that is an
 9   ongoing -- should be an ongoing discussion.
10         Q.       You go on and make the
11   statement, "If the relevant medical
12   circumstances change between preoperative
13   evaluation and the procedure itself as in this
14   case where Mr. Sullivan's INR changed and
15   thereby altered the risk-benefit ratio of the
16   procedure, then the informed consent process
17   should reflect that change.  I have seen no
18   evidence to that effect."
19                  Did I read that correctly?
20         A.       Yes.  My recollection is that
21   that data changed in the process and that I saw
22   that change in the documents.
23                  And that's why I have this
24   impression, that the process should have
25   reflected -- well, it should have reflected
0122
 1   some changes in his condition.
 2         Q.       Okay.  And, again, you are not
 3   qualified to say if the issue with the INR
 4   reflected a change in the patient's condition
 5   or not?
 6         A.       I'm not, no.
 7         Q.       And you are not qualified to
 8   comment on how an electrophysiologist would
 9   address that?
10         A.       No.
11         Q.       Or what they would say in detail
12   as far as that, correct?
13         A.       No.
14         Q.       And you cannot comment on what
15   substantively should have been told to Shannon
16   Sullivan about that?
17         A.       No.  Only that if the
18   circumstances changed, that discussion should
19   have reflected the change.
20         Q.       And you're not saying that it
21   didn't?
22         A.       I'm sorry, the "it" refers to?
23         Q.       Yes.  You're not saying that the
24   whole issue of the patient's INR was not
25   discussed by Dr. David Burkhardt?
0123
 1         A.       Well, as I recall, the INR was
 2   discussed.  I don't -- when I wrote this, I had
 3   the impression that there was some change over
 4   the period of his treatment.  Now, again, if
 5   that was the case, then that should have been
 6   discussed.
 7         Q.       And you're not commenting one
 8   way or the other, if it was, if it wasn't, or
 9   the details of that?
10         A.       No.
11         Q.       Number eight, you say, "The
12   absence of an informed consent form for surgery
13   also deprives the reader of information that
14   could clarify the extent to which the proposed
15   procedure is innovative."  Okay?
16         A.       Uh-hum.  Yes.
17         Q.       You, as a medical ethicist,
18   cannot comment whether or not this procedure
19   was, quote, unquote, innovative or not?
20         A.       I saw it described as novel or
21   innovative in some of the documents that I was
22   given.  If that's the case, then this statement
23   applies.
24         Q.       Again, what specifically
25   Dr. Burkhardt should have said to Mr. Sullivan
0124
 1   as far as the nature of this procedure, if it
 2   is considered by electrophysiologists to be
 3   innovative or not, you can't comment on what
 4   the substance of that would be --
 5         A.       That's correct.
 6         Q.       -- correct?
 7                  I would like you, if you would,
 8   just to -- I'm going to look at my notes.  I
 9   would like you to just read over this document,
10   please.
11                  MS. CARULAS:  I'm showing him
12         the report of Dr. Callans.
13                  MR. KULWICKI:  Oh, okay.
14                  (Pause)
15   BY MS. CARULAS:
16         Q.       Okay?
17         A.       Hmm.
18         Q.       You've read it quickly.
19         A.       Well, most of it is of a
20   technical nature.  And I don't hold myself out
21   as an expert on the technicalities.
22         Q.       And you, at the end of reading
23   it, did a -- I don't know how to put it on the
24   record, a "hmm," a "hmm."
25                  What was the "hmm" for?
0125
 1         A.       Well, the writer is reaching a
 2   conclusion about what Mr. Sullivan was not
 3   repeatedly advised about.  And I'm wondering,
 4   as you might, how the writer knows that.
 5                  That's this paragraph.  "It is
 6   impossible to believe that Mr. Sullivan . . ."
 7   I'm just not sure what to make of that.  And
 8   that may be true.  But it also may not be
 9   accurate.
10                  Neither the writer nor I were
11   present.
12         Q.       Okay.  The writer, Dr. Callans,
13   is someone who, in his day-to-day practice, has
14   interactions with patients and informed consent
15   discussions about undergoing this particular
16   procedure.
17                  You're aware of that?
18         A.       Yes.
19         Q.       Let me just state the obvious.
20                  He has much more experience in
21   interacting with patients and having informed
22   consent discussions on this subject than you
23   do?
24         A.       Lord knows.  Yes.
25         Q.       So that's absolutely true?
0126
 1         A.       Yes.
 2         Q.       So how to how to perform an
 3   informed consent and you -- well, let me strike
 4   that.
 5                  You say what he says, "It is
 6   impossible to believe Mr. Sullivan was not
 7   repeatedly advised about the possibility that
 8   this procedure may not be successful or that
 9   there were important potential complications,
10   including stroke."
11                  You said that may indeed --
12         A.       I don't know what's possible for
13   one person to believe and what is possible for
14   someone else to believe.  I would only say that
15   it's possible to believe that he wasn't.
16         Q.       Well, I suppose anything in life
17   is possible?
18         A.       Indeed.  That's why I think that
19   statement is not all that helpful.
20         Q.       But with you not being someone
21   who interacts and knows whether or not stroke
22   is something that is repeatedly advised as a
23   complication of this procedure, it's difficult
24   for you to comment?
25         A.       Well, that's a statement about a
0127
 1   particular set of interactions and about what
 2   the writer, you know, believed or did not
 3   believe that something happened.  It's not
 4   really about his practice and informed consent
 5   in this procedure.
 6         Q.       Well, I would think that
 7   electrophysiologists know what it is that they
 8   say to patients as far as, you know, this is
 9   what, unfortunately, can happen with this
10   procedure.
11         A.       I'm only concerned about the
12   notion that it's impossible to believe
13   something, when clearly different people may
14   believe different things.
15         Q.       All right.
16         A.       Just I don't know that that's
17   all that helpful.  If this is the physician's
18   report of what is conventionally done, I have
19   no reason to doubt that that is true, that that
20   is what is conventionally done.
21                  But the question of belief is a
22   different one in this particular case.  And
23   whether it's possible to believe something was
24   done or not done at all is a different
25   question.
0128
 1         Q.       Your getting too philosophical
 2   for me.
 3         A.       No, you're too smart for that.
 4                  MR. KULWICKI:  I'm going to
 5         object and move to strike.  I think, you
 6         know, the denigrating tone is
 7         inappropriate.
 8                  And I think, you know, you're
 9         trying to get Dr. Callans to vouch for
10         the credibility of Dr. Kanj and Nurse Poe
11         and Dr. Burkhardt.  And that's
12         inappropriate under Ohio law.  It just
13         is.
14   BY MS. CARULAS:
15         Q.       You didn't think I was trying to
16   denigrate you, did you?  I was just having fun.
17         A.       I want to stay out of it.
18         Q.       Okay.
19         A.       I feel fine.
20         Q.       Good, I'm glad.
21                  All right.  Now, this whole
22   discussion, I know you say you have some
23   interest in innovative surgeries.
24                  And you've already said you
25   don't know to what extent this would be
0129
 1   considered innovative or not.
 2         A.       Only that I've seen references,
 3   in the papers I was given, to the procedure as
 4   novel or innovative.
 5         Q.       All right.  Now, as far as this
 6   whole issue about whether or not Mr. Sullivan
 7   was in a research study, did you see any
 8   evidence that he was enrolled in any type of a
 9   research study?
10         A.       You know, it looks as though
11   his -- his data were entered into the registry.
12   And I'm trying -- I -- I'm trying not to reach
13   a conclusion about whether his data was
14   identifiable or not.  That's to say whether it
15   was -- the data that was entered in the
16   registry was linkable to him as a person.
17         Q.       Okay.
18         A.       And I -- it wasn't clear to me,
19   and it's still not clear to me.
20                  I simply wanted you to know that
21   if it was identifiable, that makes him a
22   research subject, and that requires special
23   consent to be in a research study.
24         Q.       Okay.  Again, I'm a layperson.
25                  But as far as a research study,
0130
 1   the type where there's an experiment of sorts
 2   where there's two different arms and people are
 3   randomized and all that sort of thing, where
 4   there's a big long IRB consent form, you didn't
 5   see any evidence that Mr. Sullivan was enrolled
 6   in that type of a research study, correct?
 7         A.       No, he was not -- I didn't see
 8   any evidence that he was involved in a
 9   randomized control trial.
10                  There are these trials that
11   are -- that are -- there are studies that
12   are -- that are attempts to gather what are
13   essentially epidemiological data from which one
14   may be able to draw conclusions if the number
15   of similar patients with similar conditions is
16   large enough, complete enough.
17                  And that is what I gather part
18   of this AFib registry is.
19         Q.       You know that oftentimes
20   databases are kept by hospitals or departments
21   for a number of different reasons; is that
22   correct?
23         A.       Yes.
24         Q.       They do it for quality assurance
25   reasons, correct?
0131
 1         A.       Yes.  There are quality
 2   assurance records that are not -- registries
 3   that are not required to be treated as research
 4   studies.
 5         Q.       And oftentimes you keep
 6   information for insurance purposes, obviously?
 7         A.       Yes.
 8         Q.       Certain organizations, watchdog
 9   organizations, want you to have certain
10   information so they can look back?
11         A.       Yes.
12         Q.       They want databases for that?
13         A.       Yes.
14         Q.       And those type of purposes, you
15   don't necessarily need to get IRB approval or
16   you could get an IRB waiver or all that, true?
17         A.       Well, sometimes registries -- I
18   mean, a registry could turn into something that
19   could be regarded as a research study if it --
20   if they're published in such a way as to
21   influence the knowledge of the field.
22                  At that point, you have to
23   certainly be sure that you've made all the
24   personal records non-identifiable.
25         Q.       Okay.  Oftentimes, hospitals,
0132
 1   you know, they keep data for their outcomes and
 2   to have some handle on things?
 3         A.       Yes.
 4         Q.       And oftentimes you have like a
 5   look-back?
 6         A.       That's the term that's used.
 7         Q.       And oftentimes you can look back
 8   at someone's individual hospital chart or you
 9   could look back at kind of a summary of that?
10         A.       Yes.
11         Q.       So what I want to understand, I
12   mean, you are not -- maybe I need to find out
13   if you are saying this.
14                  But, I mean, you've talked about
15   the consent form here that you think,
16   hypothetically, should have been -- we know
17   about the consent form.  But you're talking
18   about a consent form.
19                  I just want to make sure before
20   I leave here.  I mean, you're not saying that
21   the Cleveland Clinic or the electrophysiology
22   department or Dr. Burkhardt was acting
23   unethically at all in their research and
24   publication?  I mean, am I fair?
25                  MR. KULWICKI:  Objection.
0133
 1                  You can answer.
 2         A.       I'm talking here about policies
 3   and procedures.  I'm not talking about an
 4   individual person's ethics.  That's what I'm
 5   talking about.
 6   BY MS. CARULAS:
 7         Q.       All right.  I mean, you're --
 8         A.       Unfortunately, what -- so the
 9   word "ethics" is sometimes understood to be a
10   reference to somebody's moral disposition, kind
11   of, whether they're a good or bad person.
12         Q.       Right.
13         A.       And the way that people in this
14   field use the word "ethics," it's a question of
15   standards, conventions, principles.
16                  Those conventions, standards and
17   principles are created because good people
18   sometimes don't know what other good people
19   have agreed, as a matter of consensus, ought to
20   govern the practice.
21                  And so I'm not using -- when I
22   say that there was a violation of medical
23   ethics, I'm not calling anybody's personal
24   ethics into question.  I'm talking about the
25   conventions and standards of the field.
0134
 1         Q.       So you're saying that if a
 2   registry is maintained for a purpose other than
 3   what we've talked about --
 4         A.       Yes.
 5         Q.       -- it needs to, in your opinion,
 6   go to an IRB?
 7         A.       Yes.
 8         Q.       And then an IRB, in your
 9   opinion, needs to either require a consent form
10   or they can waive that?
11         A.       If --
12                  MR. KULWICKI:  Objection.
13   BY MS. CARULAS:
14         Q.       I mean, I --
15         A.       Well, an IRB, if they are going
16   to waive consent, in general, they're going to
17   do that because the information has not -- is
18   not identifiable to -- is not linkable to a
19   particular individual.
20         Q.       So, hypothetically, if there was
21   a consent form in this, which we know you think
22   there should be, and in your mind, if good
23   people are keeping registries to try to keep
24   data of, okay, we've done this many of this or
25   this many of that, what needs to be in the
0135
 1   consent form about having a registry?
 2         A.       Well, if it's a research study,
 3   then we need to tell you that your data may be
 4   entered into a research study.  It may be part
 5   of a publication.  It could be something that
 6   ultimately leads to a product or a device or a
 7   service that has commercial value.
 8                  But you will not participate in
 9   enjoying the benefits of that commercial value.
10   You won't make any money from your data or your
11   tissues, or whatever it is, being part of this.
12   And that you understand that.
13                  Now, in some cases, your data
14   may help us understand more about you
15   medically.  You need to be told, whether you
16   will be contacted or whether the whole group
17   will in some way be notified, that something
18   has been learned that's important for you
19   medically or for your family.
20                  These are the kinds of things
21   that would need to be in the consent form.
22         Q.       Right.  And, again, I mean, do
23   you have an opinion in this case or are you
24   going to say at some later time that you think
25   that the consent form for Shannon Sullivan
0136
 1   should have included all of those issues or --
 2         A.       Well, if this qualifies as
 3   research and if his data was not de-identified,
 4   then I would say that should be a separate form
 5   and process.
 6         Q.       Then what would hypothetically
 7   be in that separate form?
 8         A.       Well, what I've described to
 9   you.
10         Q.       Depending if it was applicable
11   or not, right?
12         A.       Yes.
13         Q.       I mean, you mentioned something
14   about tissue samples or --
15         A.       Right.  No.  It would obviously
16   depend on the nature of the registry, sure.
17         Q.       Are you able to give any more
18   specifics as to what, hypothetically, you think
19   should have been in a separate form?
20         A.       It would depend very much on
21   what people were looking for in the registry,
22   what conclusions they would want to draw on.
23         Q.       Beyond that hypothetical, you're
24   not giving any specific opinions in that
25   regard; is that --
0137
 1         A.       That's correct.
 2         Q.       And you are not giving any
 3   opinions as to whether or not that information
 4   would have affected Shannon Sullivan's decision
 5   to consent?
 6                  MR. KULWICKI:  Objection.
 7         That's not within his expertise.  So I
 8         object.
 9         A.       It's a kind of factual I don't
10   know how to evaluate.
11   BY MS. CARULAS:
12         Q.       Okay.  I just want to make sure
13   you will not be saying, at the time of trial,
14   that you believe that had he hypothetically
15   been given a separate consent form saying, we
16   may look at your data later to see if it will
17   help others or whatever these other situations
18   are, you aren't going to say that that would
19   have affected a reasonable person's judgment in
20   this case?
21                  MR. KULWICKI:  I object.  It's
22         not a matter for expert testimony.
23                  However, Doctor, you can answer.
24   BY MS. CARULAS:
25         Q.       Fair?
0138
 1         A.       I -- I'm not mainly or --
 2   concerned about the consequences of the consent
 3   form.  I'm mainly concerned about the need to
 4   respect the patient by having a signed consent
 5   form.
 6         Q.       I mean, this all goes in with
 7   what we've been talking about the whole time,
 8   the respect for the patient?
 9         A.       Indeed.
10         Q.       Then number ten, you say, "I
11   further note that remote magnetic navigation
12   was used in the course of Mr. Sullivan's
13   pulmonary vein ablation procedure."  And then
14   you go on to say, "It's an innovative practice
15   and as such its use should be disclosed to the
16   patient."
17                  I think we touched upon this a
18   couple hours ago, that you don't have any
19   specific understanding as to how one uses
20   magnetic navigation in a pulmonary vein antrum
21   isolation procedure?
22         A.       I do not.
23         Q.       And you would defer to the
24   electrophysiologist, such as Dr. Burkhardt,
25   Dr. Callans, as to what should be relayed to a
0139
 1   patient about magnetic navigation?
 2                  MR. KULWICKI:  Objection.
 3         A.       Yes.  With the framing condition
 4   that I had mentioned about namely that how one
 5   expresses it is of concern to me.  What the
 6   literature says, what the science says, I would
 7   defer to the physician or scientist.
 8   BY MS. CARULAS:
 9         Q.       As to what the details are.  You
10   know, I understand.  We can beat a dead horse.
11         A.       Right.
12         Q.       Have we covered all of your
13   opinions in this case as to your opinions on
14   medical ethics in this case?
15         A.       As we sit here at this moment, I
16   believe we have.
17         Q.       If at any point in time you
18   review any additional materials or come up with
19   any additional opinions on the issue of medical
20   ethics, will you relay that to Mr. Kulwicki, so
21   I am advised of it?  You'll write a supplement
22   report?
23         A.       Yes, ma'am.
24                  MS. CARULAS:  So we've been here
25         now for two-and-a-half hours, right?  So
0140
 1         what you can do is, you can bill me.  You
 2         know, you can do a separate bill, one for
 3         the deposition, and send to it
 4         Mr. Kulwicki.  He'll send it on to me.
 5         Okay?
 6                  And you have the right to read
 7         over the transcript or you can waive
 8         that.
 9                  MR. KULWICKI:  Now, before we
10         terminate the deposition.  I'm going to
11         ask you some questions, just because I
12         anticipate defense counsel raising a
13         motion before the court at some point in
14         time.
15                  MS. CARULAS:  I'm going to note
16         an objection to this.  It's my discovery
17         deposition.  But I will let you go ahead.
18                       - - -
19                    EXAMINATION
20                       - - -
21   BY MR. KULWICKI:
22         Q.       Doctor, you prepared a report,
23   which is marked as, I believe, Exhibit G.
24                  Does that set forth the opinions
25   relative to this matter?
0141
 1         A.       It does.
 2         Q.       Are those opinions stated to a
 3   reasonable degree of professional probability
 4   or certainty as a medical ethicist?
 5                  MS. CARULAS:  Objection.
 6         A.       Yes, they are.
 7   BY MR. KULWICKI:
 8         Q.       Oh, before I go on.  Your CV was
 9   marked as Exhibit H.
10                  Is that a true and accurate copy
11   of your professional credentials that support
12   your qualifications to render opinions as a
13   medical professional, a medical ethicist?
14         A.       Yes, sir.
15                  MS. CARULAS:  Objection.
16   BY MR. KULWICKI:
17         Q.       Now, in the field of medical
18   ethics, is there a clinical component to that
19   that falls within the rubric of a medical
20   professional or a health care professional?
21                  MS. CARULAS:  I'm going to
22         object.  He's previously said he is not a
23         medical professional.
24                  But go ahead.
25   BY MR. KULWICKI:
0142
 1         Q.       You can answer it.
 2         A.       So there are courses, there's
 3   literature, there are services provided and
 4   paid for by hospitals that have to do with
 5   clinical ethics.  There are ethics committees
 6   and ethics consultants that are now part of the
 7   professional standard and the institutional
 8   policy standard throughout the United States.
 9         Q.       With respect to the professional
10   activities of clinical ethicists -- well, first
11   of all, you have fulfilled that role in the
12   past?  You've been a clinical advisor to
13   physicians and hospitals --
14         A.       And to hospitals.
15         Q.       -- correct?
16                  And with respect to background
17   and training, are you qualified, based on your
18   CV and all the materials put in there and your
19   background as having been a clinical ethicist,
20   to render opinions regarding, as you say,
21   conventions, standards, policies and procedures
22   applicable to a hospital like the Cleveland
23   Clinic in terms of the form of informed
24   consent?
25                  MS. CARULAS:  Objection.
0143
 1         A.       Well, I've been asked to speak
 2   at and advise numerous organizations, including
 3   hospitals and medical schools and medical
 4   centers.  And I will let my record speak for
 5   itself.
 6   BY MR. KULWICKI:
 7         Q.       Would you agree, though, with
 8   the statement that you are qualified to render
 9   the opinions that you set forth in your report?
10                  MS. CARULAS:  Objection.
11         A.       I would agree that I am
12   qualified.
13   BY MR. KULWICKI:
14         Q.       Now, you were asked quite a bit
15   about your background in philosophy when you
16   were doing your formal education.
17                  Was there a program dedicated to
18   medical ethics anywhere?
19         A.       The field really got established
20   around the time that I finished my Ph.D.  And I
21   was one of the first people in the field in the
22   late 1970s.
23         Q.       In terms of teaching medical
24   ethicists today to go out and be advisors to
25   hospitals regarding matters of clinical medical
0144
 1   ethics, are you currently involved in training
 2   at, in fact, the largest institution that
 3   trains medical ethicists today?
 4                  MS. CARULAS:  Just a continuing
 5         objection.
 6         A.       I am.  I am a member of the
 7   faculty of the master's program in bioethics.
 8   And I teach medical students as part of my role
 9   here at Penn.
10   BY MR. KULWICKI:
11         Q.       In terms of the folks who you
12   teach, do you teach both ethicists and
13   physicians about medical ethics and how the
14   conventions, standards, policies and procedures
15   of a hospital would incorporate aspects of
16   medical ethics?
17                  MS. CARULAS:  Objection.
18         A.       I teach physicians-in-training,
19   physicians, lawyers, lawyers-in-training versus
20   social workers, people who are working for
21   pharmaceutical firms.  Just about everybody you
22   could think of.
23   BY MR. KULWICKI:
24         Q.       Do you lecture to doctors
25   currently?  I mean, is that part of the thing
0145
 1   that you do to advise them about issues in
 2   medical ethics that might apply to hospital
 3   conventions, standards, policies and
 4   procedures?
 5         A.       Yes, it is.
 6                  MS. CARULAS:  What I'm going to
 7         do is, I'm just going to have a
 8         continuing line to all of this, so I
 9         won't have to interrupt you, as to the
10         leading nature and just the whole context
11         of it.
12                  But go ahead.
13   BY MR. KULWICKI:
14         Q.       Do you agree with that?
15         A.       Yes.
16         Q.       I'm almost done, Doctor.
17                  Now, you were asked about
18   informed consent standards applicable to
19   electrophysiology procedures.
20                  In the course of your training
21   and experience, have you ever heard of
22   particular informed consent standards that
23   apply specifically to electrophysiology
24   procedures that don't apply to any other
25   surgical procedures?
0146
 1                  MS. CARULAS:  Objection.
 2         A.       No.
 3   BY MR. KULWICKI:
 4         Q.       You were asked about state law
 5   in terms of its applicability here with regard
 6   to Ohio law.
 7                  In the course of your training
 8   and experience, have you come to understand
 9   about federal laws that apply to every hospital
10   in the United States with respect to different
11   aspects of informed consent?
12                  MS. CARULAS:  Just note an
13         objection.  He's already said he is not
14         an expert in the law.
15                  But go ahead.
16         A.       I've come to be aware of and
17   have spoken, written about the federal
18   regulations with respect to informed consent in
19   human subjects research.
20   BY MR. KULWICKI:
21         Q.       And to the extent that Ohio law
22   requires informed consent to be in writing and
23   to have certain elements, to the extent that
24   Ohio law requires hospitals, like the Cleveland
25   Clinic, to comply with accepted standards of
0147
 1   hospital care, would you agree that you are
 2   competent, qualified as a medical ethicist,
 3   with your extensive CV, to comment on the
 4   standards, conventions that apply to these
 5   policies and procedures as determined by, you
 6   know, nationally accepted standards of medical
 7   ethics, federal law that applies, and also
 8   standards of hospital administration in terms
 9   of what's appropriate under the circumstances
10   of this case?
11                  MS. CARULAS:  Objection.
12         A.       Yes.
13                  MR. KULWICKI:  All right.
14         That's all I have.  Thank you.
15                  MS. CARULAS:  I have nothing
16         further.
17                  MR. KULWICKI:  Let's read.
18                       - - -
19                 (Witness excused.)
20                       - - -
21                  (Whereupon, the deposition was
22         adjourned at 1:45 p.m.)
23                       - - -
24   
25   
0148
 1               C E R T I F I C A T E
 2   
 3   
 4   COMMONWEALTH OF PENNSYLVANIA:
 5   COUNTY OF PHILADELPHIA:
 6   
 7   
                   I, CHERYL L. GOLDFARB, a Notary
 8   Public within and for the County and State
     aforesaid, do hereby certify that the foregoing
 9   deposition of JONATHAN D. MORENO, Ph.D., was
     taken before me, pursuant to notice, at the
10   time and place indicated; that said deponent
     was by me duly sworn to tell the truth, the
11   whole truth, and nothing but the truth; that
     the testimony of said deponent was correctly
12   recorded in machine shorthand by me, to the
     best of my ability, and thereafter transcribed
13   under my supervision with computer-aided
     transcription; that the deposition is a true
14   record of the testimony given by the witness;
     and that I am neither of counsel nor kin to any
15   party in said action, nor interested in the
     outcome thereof.
16   
17                 WITNESS my hand and official
     seal this 30th day of March, 2011.
18   
19   
20   
                   _______________________________
21                 CHERYL L. GOLDFARB, RPR
                   Notary Public
22   
23   
24   
25