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STATE OF INDIANA
)
) SS:
COUNTY OF LAKE
)
IN THE LAKE CIRCUIT COURT
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GLORIA SARGENT,
)
Plaintiff,
)
-v)
ARVIND N. GANDHI, M.D., ) Cause No.
CARDIOLOGY ASSOCIATES OF ) 45C01-1404-CT-0049
NORTHWEST INDIANA, P.C., )
and MUNSTER MEDICAL
)
RESEARCH FOUNDATION, INC., )
d/b/a COMMUNITY HOSPITAL, )
Defendants.
)
__________________________ )
RAYMOND KAMMER,
) Cause No.
Plaintiff
) 45C01-1404-CT-0048
-v)
ARVIND N. GANDHI, M.D., )
CARDIOLOGY ASSOCIATES OF )
NORTHWEST INDIANA, P.C., )
and MUNSTER MEDICAL
)
RESEARCH FOUNDATION, INC., )
d/b/a COMMUNITY HOSPITAL, )
Defendants.
)
The VIDEO DEPOSITION upon oral examination
of MARK ALAN DIXON, D.O., a witness produced and
sworn before me, Carol A. Byrd, CSR, Notary Public
in and for the County of Lake, State of Indiana,
taken on behalf of the Plaintiff at O'Neil,
McFadden & Willett, LLP, 833 West Lincoln Highway,
Suite 410W, Schererville, Indiana, on Wednesday,
September 3, 2014, at 6:09 p.m., pursuant to the
applicable rules.
STEWART RICHARDSON & ASSOCIATES
Registered Professional Reporters
150 West Lincolnway, Suite 1005
Valparaiso, IN 46383
(219) 462-3436
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APPEARANCES
FOR THE PLAINTIFF:
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MR. BARRY D. ROOTH, ESQ.
THEODOROS & ROOTH, P.C.
8750 Broadway, Suite A
Merrillville, Indiana 46410
-andMR. DAVID J. CUTSHAW, ESQ.
MR. GABRIEL A. HAWKINS, ESQ.
COHEN & MALAD, LLP
One Indiana Square, Suite 1400
Indianapolis, Indiana 46204
FOR THE DEFENDANT,
ARVIND N. GANDHI, M.D.
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MS. ALYSSA STAMATAKOS, ESQ.
EICHHORN & EICHHORN
200 Russell Street
Hammond, Indiana 46320
FOR THE DEFENDANT,
MUNSTER MEDICAL RESEARCH FOUNDATION, INC.
d/b/a COMMUNITY HOSPITAL:
MS. SHARON L. STANZIONE, ESQ.
JOHNSON & BELL, PC
11051 Broadway
Crown Point, Indiana 46307
- and MS. LAURA D. SENG, ESQ.
BARNES & THORNBURG, LLP
600 1st Source Bank
100 North Michigan
South Bend, Indiana 46601-1632
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FOR THE DEPONENT,
MARK DIXON, D.O.:
MS. MARIAN C. DRENTH, ESQ.
O'NEILL, McFADDEN & WILLETT, LLP
833 West Lincoln Highway, Suite 410W
Schererville, Indiana 46375
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ALSO PRESENT:
Mr. Ryan D. Anderson
Mr. Michael Charizopoulos, Videographer.
INDEX OF EXAMINATION
PAGE
EXAMINATION
BY MR. CUTSHAW
BY MS. STAMATAKOS:
BY MS. STANZIONE:
BY MR. CUTSHAW:
BY MS. STAMATAKOS:
BY MR. CUTSHAW:
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109
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INDEX OF PLAINTIFF'S EXHIBITS
NUM.
DESCRIPTION
PAGE
Exhibit 1 Summary of facts related to
48
Bi-Ventricular pacemaker implants
& AICD implants performed by Dr.
Gandhi at Community Hospital
Exhibit 6 Referred to previously marked
85
Exhibit 6 in Dr. Andress'
deposition
Exhibit 6 Referred to previously marked
20
Exhibit 6 2-15-05 letter to
Gorski, Birdzell, Fesko & Triana
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THE VIDEOGRAPHER: We are going on the record
at 6:09 p.m. Today's date is September 3rd, 2014.
This deposition is being held at O'Neil, McFadden &
Willett, 833 West Lincoln Highway, Suite 410W,
Schererville, Indiana. Here begins the videotaped
deposition of Mark Dixon, M.D. This case is filed
in the Lake Circuit Court sitting in Crown Point,
Indiana, Cause Numbers 45C01-1404-CT-0049 and
45C01-1404-CT-0048 in the matter of Sargent versus
Gandhi, M.D. and Cardiology Associates, et al. My
name is Michael Charizopoulos in association with
Stewart Richardson. I am the videographer. The
court reporter is Carol Byrd, also in association
with Stewart Richardson. Counsel may now state
their appearances for the record, and the reporter
will swear in the witness.
MR. CUTSHAW: David Cutshaw for the plaintiff,
along with Gabe Hawkins and Barry Rooth.
MS. STAMATAKOS: Alyssa Stamatakos for Dr.
Gandhi and Cardiology Associates of Northwest
Indiana.
MS. STANZIONE: Sharon Stanzione and Laura
Seng for Community Hospital.
MS. DRENTH: Marian Drenth for Dr. Mark Dixon.
1 (Pages 1 to 4)
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MARK ALAN DIXON, D.O.,
called as a witness by the Plaintiff, having been
first duly sworn, was examined and testified as
follows:
DIRECT EXAMINATION
QUESTIONS BY MR. CUTSHAW:
Q. Can you please state your name for the record.
A. Mark Alan Dixon.
Q. Dr. Dixon, my name is David Cutshaw. And I
represent the plaintiffs in this case. I will be
asking you a series of questions. If you do not
understand my question, will you ask me to repeat
it?
A. Yes.
Q. And if you do not hear me, will you ask me to speak
up?
A. Absolutely.
Q. So if I ask you a question and you give me an
answer, I am going to assume that you have both
heard and understood my question; is that fair?
A. That's fair.
Q. All right. What is your profession?
A. I am a cardiac electrophysiologist.
Q. Okay. And I don't have a CV for you. So can you
go through very quickly your med school training,
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your residency training, your fellowships, years of
completion, where they were completed, things like
that.
A. Sure. I went to medical school at Kirksville
College of Osteopathic Medicine. Excuse me, from
1982 to 1986. I did a year of rotating internship
at Metropolitan Health Center in Erie, Pennsylvania
from '86 to '87.
Two years of internal medicine residency at
St. Louis University Deaconess Hospital. Two years
of cardiology fellowship at Chicago Osteopathic
Hospital.
One year of cardiac electrophysiology training
at Illinois Masonic Medical Center.
Q. And when was that completed?
A. 1991.
Q. Are you board certified?
A. I am board certified in internal medicine,
cardiology, and cardiac electrophysiology.
Q. And are you current in all three so far?
A. I am recertified in cardiology and cardiac
electrophysiology. I elected to not recertify in
internal medicine.
Q. And where do you practice?
A. I practice at several of the local hospitals. I am
officially on staff at Community Hospital. St.
Catherine's. Methodist Northlake and Southlake.
St. Mary's, Porter, and IU LaPorte.
Q. And how long have you had privileges at Community
Hospital?
A. I don't know exactly, but I believe since about
1994.
Q. It's my understanding that at some point in time,
you were director of the EP or electrophysiology
lab at Community Hospital; is that true?
A. That is true.
Q. Excuse me. And how long were you director, what
years?
A. Approximately 1994 to 2008. That's approximately.
When I started at Community Hospital, we did it as
a joint venture with the group that I was still
with in Chicago where I trained. And then when I
broke away on my own, we were directors then, as
well.
Q. Okay. Were you directors of any other EP labs at
the same time?
A. Yes. Director of the electrophysiology laboratory
at St. Anthony's in Crown Point from 1990 to 1995
or 6.
Director of the electrophysiology laboratory
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at St. Mary Medical Center from 1995 to
approximately -- myself, until approximately 2004.
My group until just two years ago.
Q. And so you said that you were the director of EP at
Community in 2008. Who was the director that
followed you?
A. I don't know that. I believe it was my partner,
Dr. Dasari. But I think there was a period where
there was no directorship. And then he became
director for one or two years. But I'm not certain
about that.
Q. Who followed Dr. Dasari, if you know?
A. I don't know.
Q. Do you still do EP procedures at Community?
A. I do not.
Q. When was the last time that you did those
procedures at Community?
A. 2008, 2009.
Q. Is there a reason that you stopped doing EP
procedures at Community 2008 2009?
A. My practice moved more to the east. I became
busier at St. Mary Medical Center. I then became
more busy at Porter Hospital.
And then I opened the practice at IU LaPorte
in 2008. So I limit my day-to-day activity
2 (Pages 5 to 8)
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predominantly at IU LaPorte and Porter.
And I do a very small amount of
electrophysiology at St. Mary's now. And I do
nothing at the other hospitals on a day-to-day
basis. I cover them on weekends on call.
Q. As director of the EP lab at Community, did you
report to anyone, and if so, who?
A. We would report to the quality assurance committee
for quality issues. We -Q. Were you ever -- I'm sorry, go ahead.
A. We would also make recommendations to credentialing
committees.
Q. Were you ever on the QA committee at Community?
A. I don't recall being on the committee. If I was, I
was an absent participant. I never remember being
on that.
Q. And at the time that you were director, was there a
chairman of the QA committee with whom you would
deal frequently, or -A. Not frequently. I believe -- I believe Dr. C.
Richard Smith may have been the chairman. But I
don't -- I'm not certain.
Q. You said that you would also report to
credentialing committees. What credentialing
committees would you report to?
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A. It wasn't so much reporting. It was
recommendations when they would ask.
Q. What committees?
A. The credentialing committee.
Q. The entire credentialing? Were there -A. Credentialing for electrophysiologic procedures.
Q. Did it have a name?
A. If it did, I'm unaware.
Q. Okay. It's my understanding, we talked to Dr.
Kaufman, that the director of the EC lab oversees
the EP lab, oversees credentialing of the EP lab,
reviews complications, responsible for quality
assurance, and including whether or not patients
need defibrillators, or things like that. Have I
accurately stated what the duties of the EP lab
director were?
A. Yes, you have.
Q. Any other duties?
A. Yes. Writing protocols for pre and postoperative
care of patients. Writing order protocols. Early
in the experience, before it went to a corporate
level, the director of the lab would sit down with
industry to work out purchasing agreements. But
that no longer happens.
Q. That would be sitting down with manufacturers of
these devices?
A. Yes.
Q. While you were carrying out those duties in the EP
lab, did you ever have -- ever have occasion to
look at doctor's cases, any EP or cardiology cases,
to make sure that indications were there for
implantation?
A. I did.
Q. And how often would you do that?
A. We reviewed every implantation.
Q. And if you found that an implantation was not
indicated, what would you do?
A. It would be reported to the quality assurance
committee.
Q. Did you ever have occasion to make reports to the
quality assurance committee relative to implants
that were done without indication?
A. I did make reports to the quality assurance
committee when implants fell out of the guidelines
for implantation.
Q. Guidelines for implantation would be pursuant to
the Heart Rhythm Society guidelines?
A. The Heart Rhythm Society and CMS.
Q. Which is Medicare?
A. Yes.
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Q. And you indicated that on occasion you had reported
non indicated or un-indicated implants to the QA
committee. Can you recall any physicians who you
reported in that regard?
A. Dr. Gandhi was reported as one of the physicians
who had implants that fell outside of the
guidelines.
Q. Any others that you recall?
A. I had one myself that fell outside of the
guidelines that I reported to our local Medicare
director, and pursued it to a fair hearing, and it
was approved.
Q. So you reported yourself?
A. I did.
Q. Any other doctors that you can recall that you
reported?
A. No.
Q. How many times did you report Dr. Gandhi for
putting in the implants that were not indicated?
MS. STAMATAKOS: Objection, form. You can
answer.
MR. CUTSHAW:
Q. You can answer.
A. I don't know the exact number. I reviewed
approximately 12 cases. As I recall, in my opinion
3 (Pages 9 to 12)
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seven of them failed to meet all of the standard
criteria. But that is an approximation. I don't
know the exact number.
Q. Did the quality assurance committee do anything
with that information, if you know?
A. I do not know.
Q. Did you have any conversations with the quality
assurance committee members relative to those
reportings?
A. Not one-on-one.
Q. As a committee, did you have conversations?
A. No. I just reported the data.
Q. So you got this. You have reviewed 12 cases, seven
are not indicated. You report to the QA committee.
How did you do your report, in writing or orally?
A. In writing.
Q. And do you recall if it was addressed to anyone in
particular?
A. I don't recall. I think it was generic to the QA
committee.
Q. Other than C.R. Smith, do you recall anybody else
who may have been on the QA committee at the time
that you issued that report?
A. I don't.
Q. Now, it's my understanding from previous
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depositions, that Dr. Gandhi had privileges to
implant pacemakers, we will call them?
A. That is correct.
Q. And it is my understanding that he had privileges
from 2002 to 2005 to do pacemakers. Is that your
understanding?
A. He had privileges from 2002 until present.
Q. Okay. It's my understanding that in 2002, a
combination pacemaker defibrillator was approved
for use by the FDA, and that was recommended for
use pursuant to, what, the Companion study?
A. No. The Companion study was for a biventricular
device. This was the multi setter automatic
defibrillator implantation trial for prevention of
sudden death.
Q. But in 2002, the combination defibrillator was
recommended for use in many patients?
A. Yes.
Q. It's my understanding that it was a standard of
care to implant the combination pacemaker
defibrillator in 2002 to prevent sudden death; is
that fair?
A. That is true.
Q. Did there come a time when you found out that Dr.
Gandhi was implanting pacemakers in patients who
should have received the combination pacemaker
defibrillator?
A. In my opinion, yes. There were patients who would
have been candidates for -- and you are talking
about the biventricular device now?
Q. Right.
A. There were patients who would have been candidates
for biventricular defibrillators. Since the
indication for a biventricular pacemaker and
biventricular defibrillator are essentially the
same.
When the indication was released, it was
released to assist in the management of drug
refractory heart failure patients, with severe
cardiomyopathy, either ischemic or nonischemic,
with bundle branch block and wide QRS complexes.
Those were the indications for both the
biventricular pacemaker and the biventricular
defibrillator.
The biventricular defibrillator was
recommended because of other trials that showed
when heart muscle function dropped below 35
percent, sudden death was a real and present
danger.
So virtually anyone who was considered for a
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biventricular pacemaker, should have undergone
consideration for a biventricular defibrillator.
Q. So we are talking about your knowledge of Dr.
Gandhi implanting pacemakers, instead of the
biventricular defibrillator. How did that come to
your attention, and what did you do about it, if
anything?
A. As director of the laboratory, it came to my
attention because of the implantations themselves.
There were many. I do not know the number, but
well over 50.
It was brought to the attention of the quality
assurance committee that many of these patients
were candidates for biventricular defibrillator
therapy.
Q. Anything done by the QA committee about that?
A. Not to my knowledge.
Q. And I think we already talked about this, and I
apologize if I have asked it already. Did the
quality assurance committee do anything about your
report that seven to 12 implants were un-indicated
by Dr. Gandhi?
A. I received no correspondence to my letter. And
then shortly thereafter, I was asked to no longer
review the implants.
4 (Pages 13 to 16)
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Q. Who asked you no longer to -- no longer to review
the implants?
A. Well, I don't know who asked me. I was told by the
nurse manager of the lab, that we were told to no
longer review the implants.
Q. Who was the nurse manager?
A. Chris Atherton.
Q. Did she give you a reason?
A. She did not. She did not know a reason.
Q. Did she tell you who told her to tell you?
A. No, she did not.
Q. Now, when you reviewed the implants routinely for
indications, did you review the medical records, or
did you review the ICD registry, or both?
A. Often times, both. We made it a lab policy. We
wanted source documentation.
So a device, for example a biventricular
device, there were three simple criteria: Chronic
symptomatic heart failure refractory to medicine.
Now, that's the doctor's word. There is no
data that you can review on that. If the doctor
states that a patient was short of breath with
minimal exertion, we took that as a class three
indication.
A cardiomyopathy with an ejection fraction
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below 30 or 35 percent, whether ischemic or
nonischemic. And bundle branch block on the EKG.
So when I implanted a device, I brought the
source documentation from my office with the echo,
or the cath, and the EKG. And it was made part of
the medical record, in case there was auditing
later on.
Q. So those are the kinds of things that you would
look at when you reviewed other doctors' implants?
A. Exactly.
Q. Did you, when you reviewed implants and you -well, strike that.
You said that you reported yourself, and you
reported Dr. Gandhi, and you can't recall anybody
else that you reported. Did you put your own
report in writing, as well?
A. I did. But this was not at Community Hospital.
Q. Okay.
A. This was at another lab that I directed.
Q. If you were to go to the hospital and try to find
where your written reports were, where would you
go, and who would you talk to first to try to find
those documents?
A. I would start with the quality assurance committee.
There were minutes taken. But this was nine years
ago. I don't know where that trail would lead.
Q. And it's my understanding from your previous
testimony, that you had made presentations to the
quality assurance committee orally in the past;
correct?
A. I had.
Q. And there was someone there taking minutes;
correct?
A. Yes.
Q. Would that be a hospital employee taking those
minutes?
A. It would have been.
Q. When you would appear at the quality assurance
committee, there would be various doctors there, I
assume; correct?
A. Yes.
Q. Would there be hospital administrators there, if
you know?
A. I believe there was at least one administrator.
But I can't tell you.
Q. Did there come a time when you found out that Dr.
Gandhi wanted privileges to implant the BiV
defibrillators?
A. Yes.
Q. And when did that occur?
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A. I can't give you a date. I don't know. I did
release a document of recommendation to the
hospital, 2006, based on the Heart Rhythm Society's
recommendation for defibrillator implantation
privileges.
(Referred to previously marked Exhibit 6.)
MR. CUTSHAW:
Q. I am going to hand you what's been marked as
Exhibit 6 in a previous deposition, and ask you if
that is the letter to which you refer?
A. Yes, it is.
Q. And this letter is addressed to John Gorski; was he
with Community?
A. He was.
Q. To JoAnn Birdzell with St. Catherine's?
A. Yes.
Q. Were you the director of the EP lab at that time at
St. Catherine's?
A. We were the only participating electrophysiology
group at St. Catherine's. So we directed it, but I
don't believe that it was a formal title.
Q. And you also reported to Don Fesko, or sent this
letter to Don Fesko with Community; correct?
A. Yes.
Q. To Milt Triana at St. Mary's?
5 (Pages 17 to 20)
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A.
Q.
A.
Q.
Yes.
Were you the EP director at St. Mary's at the time?
I was.
This was February 15th of 2005. Does that refresh
your recollection -A. It does.
Q. -- as to when Dr. Gandhi wanted to get privileges?
A. Yes.
Q. To implant defibs?
A. Yes.
Q. And why did you write this letter to those hospital
administrators?
A. I summed that up in the last paragraph. I will be
happy to quote it: "I hope that you will consider
these guidelines and forward them on to your
respective credentialing committees for action. My
primary objective in recommending these guidelines
is safety for the patient."
"A secondary objective would be to protect the
hospital from litigation associated with the
performance of critical procedures by inadequately
trained personnel."
Q. So that last sentence you were fairly pressing,
weren't you?
A. I was. These were the recommendations by the Heart
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Rhythm Society. This was the society that I became
board certified in, that I spend over 100 hours a
year getting continuing education with, and these
are their recommendations.
Q. Now, you talk about in the last paragraph a concern
for patient safety as a primary concern. What's so
concerning about a cardiologist who wants to
implant defibrillators?
A. In my opinion, number one, you have to have an
exceptional knowledge of pacing, to branch out to
defibrillators. Now, many cardiologists have that.
But the window of opportunity, as stated by
the Heart Rhythm Society, when they were planning
on granting defibrillator privileges, consisted of,
and I quote, "primary prophylactic single chamber
defibrillators for the prevention of sudden cardiac
death in high risk individuals."
Primary prophylactic means patients had not
had cardiac arrest, they had not had sustained
ventricular tachycardia events, they were at high
risk for it.
As I understand it, the rationale for this
was, when the mated studies were approved, we felt
there was going to be a huge number of devices
going in. And the available electrophysiologists
may not have been able to meet the need of all of
the patients, especially in remote areas.
And Anne Curtis, who was the head of the Heart
Rhythm Society at that time, made a statement that
this is recommendation for vastly underserved
areas.
A vastly underserved area is not a hospital
where there were ten electrophysiologists on staff.
A vastly underserved area is southern Indiana
before they had EP labs down there. North Dakota,
remote areas where a cardiologist had to protect
patients, he could be trained to implant single
chamber primary prophylactic devices.
Secondary intention implants, that is someone
who has already had a cardiac arrest, the Heart
Rhythm Society was very explicit in stating that
those should be referred to electrophysiologists,
and all biventricular defibrillators were to be
referred to electrophysiologists, as stated by the
Heart Rhythm Society.
So patient safety was the issue.
Q. Okay. And so when you heard that Dr. Gandhi was
asking for privileges, you were concerned that
patient safety may be affected if he would be given
privileges?
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A. I don't know that I can say that. I think what I
was asking for, in this letter, was that whoever,
Dr. Gandhi, doctor anybody, who applied for
privileges, meet the requirements of the Heart
Rhythm Society.
Because if you met these requirements, number
one, you had a high pacemaker volume. Number two,
you were proctored by a cardiac electrophysiologist
on implantations and revisions.
You took a course that is certified by the
Heart Rhythm Society. Back then it was called
NASPE, North American Society of Pacing and
Electrophysiology. Now it is HRS. And you passed
the examination.
Q. In the first paragraph of your letter, Exhibit 6,
you talk about, "It is imperative that the
physicians have the appropriate expertise and
indications, techniques for implantation,
complications, programming, and follow-up of these
devices." Do you see that, the first paragraph
about the middle. It starts out: "As increasing
numbers of patients" -A. Yes.
Q. -- "are receiving these devices, it is imperative."
So it's my understanding from talking to some of
6 (Pages 21 to 24)
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your colleagues, that you could be the best
technical implanter in the world, but you still
need to have the knowledge and expertise for
indications and follow-up; is that fair?
A. That is absolutely correct.
Q. And why is that?
A. I could train anyone at this table to implant a
device.
Q. I hope not.
A. If you didn't faint at the sight of blood. The
mechanics of inserting the device is not the art of
cardiac electrophysiology.
The art of cardiac electrophysiology is
selecting the appropriate device for the
appropriate patient.
Certainly the implantation is very important.
The programming of the device requiring a knowledge
of how to properly treat certain arrhythmias versus
others.
And having a strategy for long term follow-up
of the patients. Because as the patients change,
their programming parameters change.
And so it is imperative that all of that be
met, not just the mechanics of dropping one in and
programming it out of the box at nominal. I have
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light that repetitive shocks may contribute to
cardiomyopathy.
Q. By the way, how did you find out that Dr. Gandhi
wanted to get these credentials to implant
defibrillators?
A. (No response).
Q. Did you speak to him personally, in a letter, how
did that happen?
A. I don't -- I don't recall exactly. I think it was
through the grapevine of the laboratory. I think
that I just heard that he was applying for the
privileges. I was not formally notified.
Q. There is an allegation by one of your colleagues in
previous depositions, that Dr. Gandhi implanted a
defibrillator device between 2002, 2005 without
privileges. Did you become aware of that?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. I was unaware. I was unaware of that.
MR. CUTSHAW:
Q. All right. So you talked about, I want to make
sure that I am clear on this, that the Heart Rhythm
Society issued guidelines for non-EPs to implant
these devices if they met certain criteria;
correct?
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an example for you, if you would like.
Q. Sure, that would be great.
A. I know that I am expounding. A patient has a
monomorphic ventricular tachycardia, rapid heart
rate from the lower chamber. It is 160 beats per
minute. It does not cause them to become
unconscious, but it makes them very short of
breath.
Very frequently, those patients, their rhythm
can be terminated through what's called overdrive
pacing, where the device delivers rapid pulses to
the ventricle and terminates the arrythmia without
a shock.
If you don't have knowledge of the
pathophysiology of arrythmia, and you set by
standard out of the box, that patient will get a
750 to a thousand volt shock for an arrhythmia that
may not need to be shocked.
Q. I assume those shocks are uncomfortable for the
patients?
A. They have been described as a horse kicking you in
the chest.
Q. Can they cause physical problems for the patients?
A. Many years ago, we would have told you no. But
there is actually new data that has been brought to
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A.
Q.
A.
Q.
(No response).
Right?
Yes.
And only for primary prevention, which was a person
who had not had a cardiac arrest, or history of
ventricular tachycardia?
A. Correct.
Q. And the secondary prevention was to be done by EPs?
A. Correct.
Q. And that was for patients who had had a previous
cardiac arrest, and/or ventricular tachycardia; is
that fair?
A. Correct.
Q. Now, you list these credentials in this letter,
Exhibit 6. I want to go through these and see if
you are aware of whether Dr. Gandhi met these
credentials and these guidelines.
A. Okay.
Q. Number one, did he have experience with 35
pacemaker implantations per year, 100 implantations
over the prior five years, three years?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. I believe he met that.
7 (Pages 25 to 28)
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MR. CUTSHAW:
Q. All right. Now, you talk about proctored ICD
implantation experience by -- I assume that's by an
EP?
A. Correct.
Q. And what do you mean by proctored?
A. The electrophysiologist is present, scrubbed in, at
the site of the implanting cardiologist to oversee
and guide for a successful implantation.
Q. So do you know whether, as of 2005, Dr. Gandhi had
ten proctored implantations and five revisions?
THE WITNESS: I was waiting for you to say,
"object."
A. I do not believe that he had electrophysi -- I'm
not certain. I don't believe that he had
electrophysiology proctoring of those numbers.
MR. CUTSHAW:
Q. All right. Do you know of any electrophysiologist
who agreed to proctor him?
A. No one in my group agreed. There were three groups
of electrophysiologists at the hospital at the
time. None of my group agreed. I know the second
group did not agree. There was a group from Christ
Hospital that may have volunteered to proctor, but
I'm not certain if they did.
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Q.
A.
Q.
A.
Q.
Do you know the EPs in that group?
I do.
Who are they?
Tom Petropoulos. And Tom Bump. And John Burke.
Do you know if he met the qualifications or
guidelines of number three, a proctored CRT
implantation by an EP?
A. I don't know for certain, but I am unaware that any
electrophysiologist proctored him for CRT therapy.
Q. Did Dr. Gandhi ever ask you personally to proctor
him?
A. He did not.
Q. Number 4, completion of didactic course and/or
NASPE exam. Do you know if Dr. Gandhi took a
didactic course or the exam?
A. I do not know.
Q. What do you mean by a didactic course?
A. Each year the Heart Rhythm Society at that time put
on conferences for cardiologists to outline basic
indications, basic troubleshooting, and to insure
that the education was there for cardiologists to
become proficient in single chamber defibrillators.
Q. If, let's say, a cardiologist attended a course put
on by Medtronic, or somebody like that, would that
qualify?
A. It was not within the recommendation guidelines of
the Heart Rhythm Society.
Q. And it's my understanding from talking to Dr.
Kaufman, that Dr. Gandhi failed the NASPE exam; are
you aware of that?
A. I'm unaware.
MS. STAMATAKOS: Objection, form.
MR. CUTSHAW:
Q. Number five, monitoring patient outcomes,
complication rates, and appropriate prophylactic
indications. What does that mean?
A. Okay. So, first of all, the last three words,
"appropriate prophylactic indications." That there
outlines the fact that they should only be primary
prophylactic devices non event patients.
In terms of monitoring patient outcomes, you
put in a device successfully on a Monday, and the
patient -- and I'm not saying this happened. I'm
saying, but the patient goes up to the floor. The
lab doesn't always know what happens to the patient
after that.
Certainly if the patient suffers a
catastrophic complication the next day, those have
to be brought to the attention of the quality
assurance committee.
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And I was not always made privy if something
did go wrong the next day. And I don't follow the
patients if I am not on the case.
So they have to have a self-imposed monitoring
of good outcome. And good outcome is measured by
CHS, or Medicare, as a 90 day non complication
period.
That means leads don't dislodge, people don't
get infections, patients don't get readmitted to
the hospital for an implant-related complication.
Q. So this is monitoring that should be done by the
implanter, or should be -A. Absolutely. We should hold ourselves accountable,
absolutely. When I have a complication, I report
it. I am harder on me, than I am on anyone else
when I am reporting it.
Q. Did you have occasions where Dr. Gandhi had
complications that weren't reported, do you know?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. I'm not aware.
MR. CUTSHAW:
Q. Okay. When you say monitoring patient outcomes,
did you also include the -- some type of
partnership between cardiologists and an EP, or is
8 (Pages 29 to 32)
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the cardiologist that's responsible for that?
A. I don't think that I became that specific in it.
Q. Okay. Establish patient follow-up, we talked about
that, as well?
A. Uh-huh.
Q. Maintenance of competency with 10 ICD and CRT
procedures per year?
A. Yes.
Q. All right. Now, you also say that before a
credential should be awarded, or provided,
accorded, so to speak, that you needed certain
things like documentation; correct?
A. Yes. So documentation of meeting the pacemaker
recommendation on number one, the 100 implants in
the three years prior to requesting privileges.
Q. Okay. And certification from an endorsed program,
that would be a certificate or something?
A. A Heart Rhythm Society endorsed program would award
you a certificate if you were at it.
Q. Okay. Notification of passing the exam needed to
be provided; correct?
A. Yes. If you take the exam and pass it. This is
not board certification. This is a minimal
examination to show competency in a single chamber
device implantation.
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Q. And then a letter from a proctor, an EP proctor
documenting the number of proctorships, or
implants; correct?
A. Correct.
Q. And then a letter documenting follow-up plan and
co-sign letter from an EP with whom the individual
will be collaborating. What did you mean there?
A. Well, we made the assumption that if they followed
our recommendations, an electrophysiologist would
be present for all of the initial implantations.
So we wanted the doctor to have a plan
follow-up, a wound check at certain amount of time.
Periodic visits to the office. And the
electrophysiologist to state that he was in
agreement with their planned follow-up.
Q. You were the director of EP at Community until
2008; correct?
A. Roughly, yes. I'm not certain on the years.
Q. So if Dr. Gandhi started implanting these
defibrillator devices in 2005, you would have been
presented with this documentation presumedly?
A. If they had followed my recommendations and the
Heart Rhythm Society's recommendations, I would
have been presented with that.
Q. Were you ever presented with any documentation as
noted on page two of your letter, items one, two,
three, and four from Dr. Gandhi, indicating that he
had completed and complied with those guidelines?
A. Not to my knowledge. I don't think that I ever
received anything like that. Now, what I cannot
speak about is whether any of those went to the
credentialing committee, because I was not part of
the credentialing committee.
Q. Well, you were responsible for credentialing for
procedures in the EP lab; correct?
A. No, not correct. I did not credential anyone.
Credentialing goes through the credentialing
committee.
I was responsible for reporting, if there were
problems with credentialing that I recognized. But
I was not -- I could not stand at the door and stop
that.
Q. Okay. So this was a recommendation to the
credentialing committees, and you don't know if the
Community credentialing committee followed those
recommendations?
A. I do not know.
Q. Well, as director of the EP lab, you understood
that Dr. Gandhi was implanting defibrillators while
you were director; correct?
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A. Yes.
Q. Well, what did you understand his credentials were
to do that?
A. My understanding was that he met Community's
credentialing process. He wouldn't have been
allowed to do them, unless he met Community's
credentialing process. I did not know the final
outcome of Community's credentialing process.
Q. You don't know whether or not Community's
credentialing process complied with the HRS
guidelines?
A. I do not know. I have a strong feeling that they
didn't.
Q. And why do you have that strong feeling?
A. Because that is a long process to achieve the goals
that we wanted them to do.
Q. What's the average amount of time for a
cardiologist to complete all of that?
A. Well, the conference comes up every six months. So
if you were lucky and you got all of your proctored
implants, which is no easy feat.
You know, you have to have an
electrophysiologist available at the time that you
are going to do the procedure.
And if you took the exam because it happened
9 (Pages 33 to 36)
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to come up at that time, three to four months,
minimum. Nine to ten months, if you missed the
exam.
Q. I see. Now, Dr. Andress was deposed in this case,
and he testified in words or in substance that
before 2005, the hospital was following the HRS
guidelines regarding -- generally regarding
credentialing of doctors; do you agree with that?
A. Yes.
MS. STAMATAKOS: Objection, form.
MR. CUTSHAW:
Q. And what were those requirements before 2005, you
had to be an EP basically?
A. You had to complete an electrophysiology fellowship
with documentation of implantation, supervised by
the solo operator.
Q. As far as you know, were the guidelines followed
after 2005, the HRS guidelines followed as to
credentialing?
A. I don't know the answer to that.
Q. Your presumption is that they weren't, though?
MS. STAMATAKOS: Objection, form.
MR. CUTSHAW:
Q. Correct?
A. That was --
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MS. STAMATAKOS: Objection as to form.
THE WITNESS:
A. -- what I mentioned to you. Yes.
MR. CUTSHAW:
Q. Dr. Kaufman testified in words or in substance that
HRS guidelines for credentialing were not just
national, they were international; is that true?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. That is true.
MR. CUTSHAW:
Q. And why do you agree that they are international?
A. The Heart Rhythm Society is the sort of sine qua
non of electrophysiology. Every year -- this year,
for example, there were 17,000 physicians,
electrophysiologists at the Heart Rhythm Society
meeting. And some 9,000 of them were
international.
Everyone tries to follow the Heart Rhythm
Society recommendations, many of Europe, European
countries have their own societies. But if you
look at their recommendations, they coincide very
closely to what HRS recommends.
Q. Dr. Kaufman testified in words or in substance that
the HRS guidelines in 2004 -- 2004/2005, in the
addendum were set forth the standard of care for
hospitals credentialing non-EPs to implant
defibrillators; do you agree with that?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. It's my understanding that that was the intention
of both the guidelines and the addendum.
MR. CUTSHAW:
Q. To set a standard of care for hospitals?
A. I believe that is what they wanted.
Q. Well, do you yourself believe that it is the
standard of care?
A. Absolutely.
Q. You talked about proctoring in your letter, Exhibit
6, for ten implants and a revision. What's a
revision?
A. A patient who had a device, for example. Well,
let's use the example of a biventricular pacemaker,
who was going to be upgraded to a defibrillator.
That would be a revision.
A patient who had a device whose lead
fractured and needed a new lead, that would be a
revision.
Q. How about a recall issue?
A. In its most strict standard, that would be
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considered a revision. But when there is a recall,
for example, of a pulse generator, it's a simple
generator replacement.
It's a little more complex if there is a lead
recall, and Lord knows we have seen enough of those
in the last many years. And, yes, that would
qualify as a revision. Because another piece of
hardware would have to be added, into addition to
that which is present.
Q. Do you know whether -MR. CUTSHAW: I'm sorry?
MS. DRENTH: I was just asking if he wanted a
break, and he said that he's okay.
MR. CUTSHAW:
Q. Do you know whether Dr. Bhagwat, while you were
director of the EP, also obtained privileges for
implantation of defibrillators?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. I do not know if he obtained it. But I didn't know
him to have it at Community Hospital, either.
MR. CUTSHAW:
Q. How about Dr. Asfour?
MS. STAMATAKOS: Objection, form.
10 (Pages 37 to 40)
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MS. STANZIONE: Objection, form.
THE WITNESS:
A. I don't know if he had credentialing or not.
MR. CUTSHAW:
Q. I think that we talked about this a little bit, but
Drs. Andress, Kaufman, and Dasari testified that
the HR guidelines were designed to record non-EP
defib implant privileges, only if the area was
remote and underserved by EPs; was that your
understanding, as well?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. Yes. That was the intention, as stated by Anne
Curtis, who was the president of the Heart Rhythm
Society. That was the intention of the document,
to provide the service to an underserved area.
MR. CUTSHAW:
Q. Do you know if that was put in writing?
A. I believe that she made a statement. Yes, I think
that could be found.
Q. And I think that at the time that Dr. Gandhi
received privileges for defibrillator implants in
2005, there were nine or ten EPs in the Lake County
area; is that correct?
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A. There were no less than seven.
Q. Would you consider seven EPs in the Lake County
area an underserved area?
A. In my opinion, no.
Q. How many EPs are in Lake County today?
A. Upwards of 12.
Q. I assume the same would be, the credentials would
be the same for today, it's not underserved; is
that correct?
A. No, it is not.
Q. You talked a little bit about the fact that EPs are
supposed to, as opposed to cardiologists or
non-EPs, implant for secondary prevention. And why
is that?
A. A patient who has not had a cardiac arrest yet, is
at a theoretical risk for developing one. A
patient -- so if you look at the data, there is a
four to six percent annual incidence of sustained
ventricular arrythmia, and that's under.
A patient who has had sustained ventricular
tachycardia, or ventricular fibrillation, has a 15
to 25 percent incidence of recurrence. They are
the highest risk individual.
That's what prompted the Heart Rhythm Society
to recommend EPs to secondary prevention. Because
those happen very frequently during the implant.
Q. So, but why can't a cardiologist take care of that?
A. It's not that they can't. There is a level of
expertise that one to two years of training brings
you, when you do nothing but manage arrythmia.
And during the implant when you are focused on
the surgery, unexpected things happen, like
episodes of ventricular tachycardia.
When you pass those wires into the ventricle,
and they touch the ventricle, they create extra
beats. And the extra beats frequently will induce
arrythmia.
So you have to have an experienced operator to
deal with that appropriately.
Q. Did you have any conversations with anyone in the
hospital administration on the issue of non-EP
credentialing for defibrillator implants, and if
so, with whom?
A. I did have that conversation. It was with John
Gorski.
Q. And when was that conversation?
A. When?
Q. Yes.
A. I have no idea. Somewhere around that time. But I
don't know.
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Q. Somewhere around 2005?
A. Yes. When this whole issue was coming to light.
Q. And can you tell me what you said to him, and what
he said to you?
A. My recollection of the statement was, I want to be
very, very cautious that the guidelines be
followed. And that doctors who apply for these
privileges meet the criteria. Patients who are
not -- or doctors who are not certified, according
to the proper credentialing, should not be doing
them.
Q. And what was Mr. Gorski's response?
A. The response to me was, "I understand your concern.
But we have a very large producer here who wants
the privilege."
Q. Do you know what he meant by, "large producer"?
MS. STANZIONE: Objection, form.
THE WITNESS:
A. I think you would have to ask him what he meant by
large producer. I don't know what he meant.
MR. CUTSHAW:
Q. What did you perceive him to mean by that?
A. I don't have a suspicion. I do believe that he
felt that he wanted Dr. Gandhi to be privileged,
but that's all that I know.
11 (Pages 41 to 44)
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Q. So when he said, "large producers," you took that
to refer to Dr. Gandhi?
A. I did.
Q. Anything else that you and Mr. Gorski discussed at
that meeting, that you recall?
A. I don't recall it.
Q. When he told you that, "Yes, we have large
producers that we want to have privileges," did you
object, or say, "You are crazy," or -A. I believe that I did say that a large producer
isn't a reason to have privileges. Meeting
criteria is the reason.
Q. Anything else about that discussion?
A. That's all. That's all that I recollect.
Q. Do you have any knowledge of Dr. Gandhi trying to,
or taking control of any internal hospital
committees to help him obtain those privileges?
A. I don't know that I have knowledge. You know, you
hear a lot of things throughout the hospital. But
I don't have personal knowledge of them. I do know
that many people that he works with are on
strategic committees.
Q. Who is on strategic committees?
A. I don't know them now. I don't know them now. I
haven't set foot in Community, except on weekends,
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for years.
Q. Do you know who at the hospital would -- well,
strike that.
How does someone get on a committee? Do they
get appointed by the hospital administration, do
they get elected?
A. No, I think that they get elected. There are
people who volunteer. And the medical staff elects
positions like president, vice president, etc.
And then I think that committees are opened up
to physicians who want to be on them. And if the
positions are overfilled, I believe the director of
the committee is the one who is responsible.
I am speaking a little off the cuff here. I
don't know that for certain. I have never been the
director of any committees at Community Hospital,
so I don't know how that works.
Q. Do you know whether Dr. Gandhi is the director of
the EP lab today?
A. Today, I have no knowledge.
Q. Do you know if he ever was?
A. I don't think that he was ever the director of the
EP lab. He was the director of the cath lab, but I
am not certain about that.
Q. Okay. Were you aware of any rules changed to allow
Dr. Gandhi to get privileges, such as a proctoring
by a partner?
A. I am aware that he was proctored by a partner.
Q. Who was he proctored by?
A. Dr. Bhagwat.
Q. And was there a rule, prior to that proctoring at
the hospital, that partners should not proctor each
other?
A. I don't know that rule, whether it existed or not.
I don't know that.
Q. Do you think that it's a good idea for partners to
proctor each other?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. I think that, for example, if there is one
individual who is doing something that no one else
can, it would be reasonable for him to proctor his
partners in that situation.
But in the situation of defibrillators, I
believe the proctoring physician should have been
an electrophysiologist. So there are occasions
where I could proctor a partner, and I have.
But that's when he and I were the only two
doing the procedures in the hospital. And so
someone had to show, when he applied for the
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privilege, that he was competent at it.
MS. DRENTH: Can we take a quick break?
MR. CUTSHAW: Sure.
THE VIDEOGRAPHER: The time is 7:06 p.m., and
we are off the record.
(Plaintiff's Exhibit 1 marked for
identification.)
THE VIDEOGRAPHER: This marks the start of
videotape number two in the deposition of Mark
Dixon, D.O. We are on the record at 7:15 p.m.
MR. CUTSHAW:
Q. Doctor, before you look at Plaintiff's Exhibit 1, I
want to talk to you a little bit more about this
directive that was communicated by Nurse Atherton
that you not review implants anymore. Do you
recall that testimony?
A. Yes.
Q. Do you remember when that directive was given to
you?
A. Shortly after we called attention to the implants
that were reviewed that did not meet criteria.
Q. Do you know when that was?
A. I don't.
Q. Well, I think you told us earlier that one of your
duties, as the director of EP, was to look for
12 (Pages 45 to 48)
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indications; correct?
A. Correct.
Q. And so when you were stripped of one of your
duties, how did you feel about that?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. How did I feel about it? Confused, agitated.
MR. CUTSHAW:
Q. Why confused and agitated?
A. Because I was stripped of my duty.
Q. Were you concerned for patient safety, as a result
of being stripped of that duty?
A. Well, in my opinion that seven of the 12, or
whatever it was, were not appropriate, I was
concerned. Yes.
Q. Well, why would you be concerned for patient
safety, if you saw that seven of 12 implants were
unnecessary?
MS. DRENTH: I am just going to object. It
misstates the prior testimony.
MS. STAMATAKOS: I will join.
MR. CUTSHAW:
Q. Okay. Would you be concerned for patient safety,
after you saw that seven of 12 implants were not
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indicated?
A. Yes.
MS. STAMATAKOS: Objection, form.
MR. CUTSHAW:
Q. Why?
A. Why would I be concerned?
Q. Yes.
A. If they are not indicated, it is a needless
surgery, in my opinion.
Q. Does that subject the patient to certain risks?
A. Absolutely. Every surgery carries risk.
Q. Would you want a defibrillator implanted in you, if
you didn't need it?
A. I would not.
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
MR. CUTSHAW:
Q. Why not?
A. Several reasons.
MS. STAMATAKOS: Objection.
THE WITNESS: Should I proceed?
MS. DRENTH: Yes, based on the objection.
THE WITNESS: Okay. Because I keep hearing
all of this objection, and I don't know what to do
next.
MS. DRENTH: These objections are made for the
record.
THE WITNESS:
A. Okay. Why would I not want a defibrillator
implanted in me, if I didn't need one?
MR. CUTSHAW:
Q. Yes.
A. Several reasons. Number one, you can die during a
defibrillator implantation. You can suffer a
pneumothorax during a defibrillator implantation.
You can get an infection from a defibrillator
implantation that goes all of the way down inside
your heart.
You can receive needless shocks from a
defibrillator if it is not programmed
appropriately.
There are several things that can go wrong
with a defibrillator. These things, when in expert
hands, are pretty low in incidence.
They still happen with even the experts. But
I certainly wouldn't want one if I didn't qualify
for one.
Q. Well, when you were stripped of your duties as EP
director, as communicated by Nurse Atherton, did
you talk to anybody about it?
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A. Absolutely not.
MS. STAMATAKOS: Objection, form.
MR. CUTSHAW:
Q. Did you complain to anybody?
A. No.
Q. Why didn't you complain to the hospital
administration, or the QA committee?
A. I don't know that I have an answer as to why I
didn't. I just didn't feel that I would get
anywhere.
Q. Why didn't you feel that you would get anywhere?
A. Because they took me off of it, in the first place.
Q. They, who is "they"?
A. I don't know. Whoever they are. Whoever made the
decision to eliminate me from doing it. I didn't
get a correspondence. I didn't get a letter.
I was just told. And by the way, Nurse
Atherton has been my nurse for 23 years. She was
told, to tell me, that I did not need to review
them anymore.
Q. Well, did you have any discussions with Nurse
Atherton?
A. No.
Q. Like, "What's going on, why am I" -A. No.
13 (Pages 49 to 52)
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Q.
A.
Q.
A.
No?
No.
Did you just say, "okay," and that's it?
I said, "If I am not asked to do it, I will not do
it."
Q. While you were director of the EP lab at Community,
were you aware of Dr. Gandhi, or anyone from his
group, doing implants for secondary prevention?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. There were implants for secondary prevention.
MR. CUTSHAW:
Q. Who did them?
A. Dr. Gandhi.
Q. And how do you know that there were implants for
secondary prevention?
A. In review of the cases, I found one or two
occasions that the patients had already had
sustained arrhythmias. Also if I am correct, I
believe one of your cases is a secondary intention.
Q. That would be Sargent, Gloria Sargent?
A. Correct.
Q. So when you found this out, did you do anything,
and if so, what did you do?
A. I made mention to the quality assurance committee
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that secondary intention was not the original
directive of the Heart Rhythm Society.
Q. Did the QA committee do anything?
A. If they did, I am unaware.
Q. You talked in your letter, Exhibit 6, that there
was concern for litigation arising from the
performance of critical procedures by inadequately
trained personnel.
Did you ever observe inadequately trained
personnel doing implants in the EP lab, and if so,
who?
MS. STANZIONE: Objection, form.
THE COURT REPORTER: I'm sorry, who said -THE WITNESS:
A. That's a difficult one for me to answer, because I
don't know. I have no knowledge of what finally
ended up being the criteria for privilege.
MR. CUTSHAW:
Q. Well, if the criteria for privileging doesn't meet
HRS guidelines, do you think that it's appropriate
criteria?
A. In my opinion, the HRS guidelines are the
appropriate criteria. So if the credentialing does
not meet that, then I don't believe that it's
appropriate.
Q. So I may have asked you this before, and if I did I
apologize. But did you have any conversations with
any of the people that you sent this letter to,
regarding your letter and the contents of the
letter, Exhibit 6?
MS. DRENTH: Objection, that's been asked and
answered.
MS. STANZIONE: Objection.
MR. CUTSHAW:
Q. Did you have conversations with Birdzell?
A. I spoke with JoAnn, I spoke with Milt. They
assured me that the electrophysiologist would
remain the implanting physicians.
Q. And we talked about your discussion with
Mr. Gorski. Did you have a discussion with Mr.
Fesko?
A. I did not.
Q. I assume that you were not assured by either that
the HRS guidelines were the guidelines set forth in
your letter would be followed?
A. I was not assured.
Q. If you will look at Plaintiff's Exhibit 1. Go
ahead and read that, and then I have some questions
about it. And for the record, it is my
understanding that this is a report generated by
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Brian Decker, who was formally with Community
Hospital. By the way, do you know Brian Decker?
A. I know Brian well.
Q. What was Brian Decker's position at Community?
A. He was the director of the cardiac catheretization
and EP lab.
Q. I thought that you were the director?
A. Not medical director. He was the nursing director.
Q. Okay.
A. Or technology director.
Q. All right, thank you.
MS. STAMATAKOS: I'm sorry, did you say at
Community?
THE WITNESS: Yes.
(Pause)
THE WITNESS:
A. So could you clarify for me, you say this note was
generated by Brian?
MR. CUTSHAW:
Q. It is my understanding that it was generated by
Brian Decker. I would like you to read it, and
then we have some questions about it.
(Pause)
MR. CUTSHAW:
Q. Have you had a chance to read Plaintiff's Exhibit
14 (Pages 53 to 56)
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1?
A. I have.
Q. Do you have any basis to state that anything in
this document is not accurate?
MS. STAMATAKOS: Objection, form.
MS. DRENTH: Objection to the form of the
question. Speculation, it is overly broad and
vague. It is a three page document that he just
now has had the opportunity to read.
MR. CUTSHAW:
Q. You can answer the question.
A. I forgot what the question was.
Q. Do you have any basis to give us any indication
that anything in here is inaccurate?
MS. STAMATAKOS: Objection to form.
MS. STANZIONE: Objection to the form of the
question.
MS. DRENTH: Same objection as before. It
calls for speculation, it's vague, and it is overly
broad. There's a lot in here.
THE WITNESS:
A. In my opinion, I don't think that anything that is
stated here is grotesquely inaccurate. However, I
want to qualify that with, I don't know the behind
the scenes interactions that got him his privilege.
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MR. CUTSHAW:
Q. Okay. Did you ever have any conversations with
Brian Decker regarding any of the issues set forth
in this memorandum?
A. I did.
Q. What issues did you discuss with Brian Decker, and
what was the content of those discussions?
A. As I recall, one of the concerns that I had was
that Dr. Bhagwat proctored Dr. Gandhi in device
implantation.
Dr. Bhagwat, at the time, as far as I know,
did not have clinical privileges for device implant
at Community Hospital during all implants. And
made statements that implied that he did, at St.
Margaret's. And I don't know if he did or didn't.
But regardless of all of that, it still was
not an electrophysiologist proctoring a
cardiologist.
So whether we want to dance around the fact
that someone did or didn't have privileges while
proctoring, it still did not meet what was
recommend for appropriate proctoring.
Q. And that was a discussion that you had with Brian
Decker?
A. Yes.
Q. What other discussions did you have with Brian
Decker that relate to what you just read in
Plaintiff's Exhibit 1?
MS. STAMATAKOS: Objection, form.
MS. DRENTH: The same objection, it's very
broad and vague.
THE WITNESS:
A. The only other conversation that we did have was
the lack of source documentation to justify
biventricular devices.
MR. CUTSHAW:
Q. What do you mean by that?
A. Okay. There was a form where you had to state the
patient's New York Heart Association functional
class.
At the time, Class III and IV were the only
indications for the device. Again, that's
word-of-mouth. And you have to trust the
cardiologist, or the electrophysiologist.
Ejection fraction documentation was stated,
but not source documented. Source documentation
means that you have the document there that shows
what the ejection fraction was.
And the EKG criteria, if present, were not
always appropriate for implant, in my opinion.
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Q. You had that discussion with Brian Decker?
A. I did.
Q. So, you indicated that you reviewed 12 cases, and
seven were not -A. Approximately.
Q. Approximately. Seven weren't indicated,
approximately?
A. Yeah. I just, you know, it's nine years ago. And
I don't want to be one off and perjure myself here.
But, yeah, more than that.
Q. Well, did you notice that there was no
documentation of an EKG QRS greater than 120 or
130?
A. There were frequently EKGs that were not greater
than 120.
Q. Is that only in the proximate 12 that you reviewed,
or were there other cases that you saw?
A. Only in the ones that I reviewed.
MS. STAMATAKOS: Objection, form.
MR. CUTSHAW:
Q. All right. Mr. Decker talks about, at the end of
page one of this exhibit, Dr. Gandhi attempting
unsuccessfully to get several of the local EPs, Dr.
Dixon, Dr. Burke to proctor him for AICD
implantation. Did Dr. Gandhi attempt to get you to
15 (Pages 57 to 60)
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proctor -A. He never requested -MS. STAMATAKOS: Objection, form -- hold on.
Objection, form and move to strike.
THE WITNESS: Oh, sorry.
MS. STAMATAKOS: That's okay.
MR. CUTSHAW:
Q. You can answer.
A. Okay. He never approached me to train him in ICDs.
Q. Were you aware of him approaching Dr. Burke?
A. I was not aware.
Q. So this would be part of this document that would
not be accurate?
MS. STAMATAKOS: Objection to form.
MS. DRENTH: Objection, misstates his
testimony.
MR. CUTSHAW:
Q. No. This says that Dr. Gandhi attempted to get
several of the local EPs to proctor him. One was
Dr. Dixon. And you told me that you were never
approached by Dr. Gandhi?
A. I was never asked to proctor him.
Q. Right. So this part of the document would not be
accurate?
MS. STAMATAKOS: Objection, form.
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THE WITNESS:
A. Yes, it would not be accurate.
MR. CUTSHAW:
Q. All right. With respect to paragraph D on the
second page, do you have any information regarding
that paragraph; do you know anything about it?
MS. DRENTH: I am just going to object. It is
a very broad question, vague.
THE WITNESS:
A. When you say do I know anything about it, I don't
know anything about it. I find -- I mean, it's a
statement of fact, apparently.
MR. CUTSHAW:
Q. Okay. But is this something that is now news to
you, the content of Exhibit D -- or Plaintiff's
Exhibit 1, paragraph D?
A. Yes, yes.
Q. Okay. Paragraph F, the second page of Plaintiff's
Exhibit 1. You talked a little bit about Dr.
Bhagwat indicating that he had privileges at St. -at Community, when you did not believe that he did.
Were you aware of whether or not he had privileges
at St. Margaret's to implant these devices at the
time that he was proctoring Dr. Gandhi?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. I know nothing about his privileging at St.
Margaret's. I'm not on staff there.
MR. CUTSHAW:
Q. I got the impression from what you said earlier,
though, that you believe that Dr. Bhagwat was not
completely forthcoming or honest, in whether he had
privileges at Community. Was my impression
correct?
MS. DRENTH: Objection -- sorry.
MS. STAMATAKOS: Objection, form.
MS. DRENTH: Objection, misstates his prior
testimony.
THE WITNESS:
A. Yes, it's a bit speculative. However, I think what
is misleading here, Dr. Bhagwat is Dr. Gandhi's
partner who practices primarily at St. Margaret,
but maintains privileges at Community Hospital. He
maintains cardiologist privileges at Community
Hospital. I don't know if he had electrophysiology
device implantation privileges.
MR. CUTSHAW:
Q. I see.
A. At that time.
Q. I see.
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A. It said that he applied for AICD privileges at
Community Hospital approximate to the timeframe
when Dr. Gandhi was trying to change the
prohibition.
He implied that he had already gotten ICD
privileges at St. Margaret's when applying to
Community. The privileges were granted. I don't
know the timeframe on all of that.
MS. STAMATAKOS: I just move to strike the
preceding testimony.
MR. CUTSHAW:
Q. All right. But, I mean, is this news to you,
again? Or is this something that you were aware of
while you were director of EP at Community?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. I was unaware if he had privileges or not.
MR. CUTSHAW:
Q. Okay. For implantation at Community?
A. For implantation of single chamber defibrillators
at Community.
Q. Okay. You talked a little bit about the fact that
you were aware that Dr. Bhagwat had proctored Dr.
Gandhi. What concerns do you have about a
cardiologist proctoring another cardiologist in EP
16 (Pages 61 to 64)
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procedures?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. So the Heart Rhythm Society was clear that in its
indications and in its recommendations, that an
electrophysiologist should train a cardiologist in
an electrophysiology-based procedure. That's the
concern that I have.
MR. CUTSHAW:
Q. Do you have any personal concerns? I mean, I know
what you are saying the HRS rhythm, Heart Rhythm
Society guidelines are. But you, as an
electrophysiologist physician, do you have
concerns?
A. I do.
Q. For a cardiologist training or proctoring another
cardiologist, and if so, what are your concerns?
A. Yes, I do. I believe that all cardiologists, it is
my opinion, should be trained by an
electrophysiologist.
For example, we are talking about someone who
has done 10, 20, maybe 30 implants, as opposed to a
well seasoned electrophysiologist who has done over
1,000 to 2,000 implants. So there is a lot more to
be learned from that personal experience.
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Q. When you are going through your fellowship, did you
have to do a certain number of defibrillator
implants, or implants before you got certified?
A. I did. However, when I was doing my fellowship,
they were in the realm of electrophysiologists with
cardiovascular surgeons, because they had not
become transvenous yet on metal. But once they
became transvenous, yes. We had to do a number of
implants.
Q. How many did you have to do?
A. I did over 50 in my one year.
Q. On the third page of this -- strike that.
On the second page, paragraph 2 A, this talks
about Dr. Gandhi bringing back his previous
pacemaker implant patients for upgrades,
essentially. Were you aware of that?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. I was aware.
MR. CUTSHAW:
Q. And how did you become aware of that?
A. Through hearsay through the laboratory.
Q. And what do you mean, through hearsay?
A. People make mention that, "Oh, he got a
biventricular pacer last year, and now he is
getting upgraded to a biventricular defibrillator
this year."
Q. When you heard those statements, did that cause you
any concern?
A. It caused me great concern.
Q. Why?
A. I answered that for you earlier in the deposition.
The indication for a biventricular pacemaker is the
same as for a biventricular defibrillator. And
over 90 percent of the people who qualify for one,
should get the defibrillator.
Q. Well, did you have concern that Dr. Gandhi was
implanting pacemakers. And then after he got
privileges to implant defibrillators, upgraded
them, when they should have had the defibrillator
in the first place?
MS. STAMATAKOS: Objection, form.
MS. DRENTH: Speculation, compound question.
MR. CUTSHAW:
Q. Did you have that concern?
A. I had concern.
Q. Why?
A. In my opinion, those patients should have gotten
biventricular defibrillators.
Q. And since they didn't, did those patients undergo
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any -- strike that.
Since they didn't get the defibrillators
initially, my understanding is that they had to go
through another server?
A. They did.
MS. STANZIONE: Objection to the form.
MR. CUTSHAW:
Q. Is that something that would be concerning to you,
that the patient had to go through two procedures
instead of one, and if so, why?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. Yes, it is concerning to me.
MR. CUTSHAW:
Q. Why?
A. Because the vast majority of people who get
biventricular pacers, should be getting
biventricular defibrillators in the first place.
Q. Page three of Plaintiff's Exhibit 1, paragraph
three, the last sentence: "There were numerous
reports from staff members of QRS durations and
ejection fractions being changed to meet criteria
at the time of the implant by Dr. Gandhi."
Did you ever see situations where a QRS on an
17 (Pages 65 to 68)
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EKG was overstated to be an indication for an
implant by Dr. Gandhi?
MS. STAMATAKOS: Objection, move to strike and
form.
MR. CUTSHAW:
Q. You can answer.
MS. STANZIONE: Join.
THE WITNESS:
A. In my review of the implants, there were EKGs that
did not meet the criteria.
MR. CUTSHAW:
Q. Well, did you see any situation where Dr. Gandhi
would, in an operative note, or a procedure note,
misstate the QRS on the EKG?
MS. STAMATAKOS: Objection, form.
MS. DRENTH: Just objection, speculation.
MS. STANZIONE: Join.
THE WITNESS:
A. Yes.
MR. CUTSHAW:
Q. How many times did you see that?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. I don't have an exact number for you. But more
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than half of the ones that I reviewed that didn't
qualify were on the basis of QRS width.
MR. CUTSHAW:
Q. All right. So let's get this straight. An EKG was
done, it reports out a QRS electronically; correct?
A. Correct.
Q. And a QRS is, for example, 80 in a certain patient.
When you looked at the operative note or procedure
note done by Dr. Gandhi, was that a QRS overstated
as an indication for a defibrillator?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. In my review, there were -- I'm not going to say
yes to 80, okay. What I am saying is, the QRS did
not meet the 120, and was stated as 120.
MR. CUTSHAW:
Q. Okay. And is that one of the things that you
reported to the quality assurance committee at the
hospital?
A. It was.
Q. And you reported that in writing; correct?
A. I think so.
Q. Okay. So if a doctor is misstating findings in an
EKG to be able to do a procedure, is that something
that you think the hospital administration should
do something about?
MS. STANZIONE: Objection, form, lack of
foundation.
MS. DRENTH: I am going to object to the
compound question, calls for speculation. Are you
stating it as a hypothetical, or -MR. CUTSHAW:
Q. You told me earlier that you saw situations where
Dr. Gandhi overstated the QRS in a procedure note;
correct?
A. Correct.
Q. Is that something that a hospital administration
should be concerned about?
MS. STANZIONE: Objection, calls for
speculation, lack of foundation.
MS. DRENTH: The same objection.
THE WITNESS:
A. It is something that first should be handled on the
physician end in the quality assurance committee.
But if I was running a hospital, it would concern
me.
MR. CUTSHAW:
Q. What would you do about it, if you were running the
hospital?
A. That's a pretty speculative situation. I would
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identify it as something that needed to be reviewed
by peers, and stopped.
Q. Would you think that it's below the standard of
care for a hospital to know that a physician is
doing unnecessary surgeries, but yet continued to
give that physician privileges to do those
surgeries?
MS. STANZIONE: Objection, that calls for
speculation, lack of foundation, misstates the
evidence.
MR. CUTSHAW: Oh, I don't think that it does.
MS. STANZIONE: I do.
MR. CUTSHAW:
Q. Do you think that it's below the standard of care
for a hospital, who knows that a doctor is
unnecessarily doing surgeries, to continue to give
that doctor privileges, and if so, why?
MS. STANZIONE: The same objection.
MS. DRENTH: I am also going to object. He is
testifying as a fact witness based on his own
personal observations.
MR. CUTSHAW:
Q. Is it below the standard of care, Doctor?
A. I believe that it is.
Q. Thank you. Dr. Andress testified in words and
18 (Pages 69 to 72)
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substance during his deposition, that the hospital
QA committee investigated Dr. Gandhi's implants,
and found that 75 percent were non indicated, were
you aware of that?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. I am not aware of that number exactly. I am aware
that many of them were not indicated.
MR. CUTSHAW:
Q. All right. Do you know if anyone else, other than
yourself, reviewed cases and reported to the QA
committee?
A. I -- this is hearsay. I don't know this to be
true. But I heard that they sought an outside
opinion on the indications.
Q. Was that from Dr. Brad Knight?
A. That's what I heard.
Q. Okay. And did you hear what Dr. Brad Knight's
conclusions were?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. I heard that his conclusion -- conclusions echoed
mine.
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MR. CUTSHAW:
Q. And did you understand that his conclusions were
communicated to the QA committee of the hospital,
as well?
A. I don't know that. I don't know who sent, if -- if
-- I actually don't know if the documents were sent
to Brad Knight. This was hearsay.
Q. All right. Who did you hear that from?
A. I don't remember. One of the lab personnel,
another doctor along the way. I don't remember who
made that statement.
Q. Dr. Andress testified in words or in substance that
when -- that when Dr. C.R. Smith complained that
Dr. Gandhi's privileges to do these implants were
not revoked after that 75 percent un-indicated
finding, he was dismissed from the committee. Did
you know about that?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. I knew nothing about that.
MR. CUTSHAW:
Q. After your findings that approximately seven to 12
of his implants were not indicated, were you
informed as to any repercussions to Dr. Gandhi as
to his privileges?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. I was not informed of any repercussions.
MR. CUTSHAW:
Q. Did you see his implantation schedulings slow down?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. I did not at that time.
MR. CUTSHAW:
Q. Is it your view that a hospital administration has
the duty to protect patients from undergoing
unnecessary surgeries by physicians?
MS. STANZIONE: Objection, form.
THE WITNESS:
A. It's my view that everyone who is involved in the
hospital has the obligation to protect patients
from inappropriate procedures.
And when I say everyone: Doctors, nurses,
administrators, directors. There's a reason that
Medicare has created the whistleblower, and we all
have the responsibility of protecting the patient.
Q. After you reviewed Dr. Gandhi's cases, do you know
if anybody else was asked to keep an eye on his
practices after you reported to the QA committee?
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A. I am not aware.
Q. Is it the QA committee that is supposed to fair it
out, issues of unnecessary procedures at a
hospital?
A. If there is a question on unnecessary procedure, or
really excessive complications, yes. The QA
committee has the immediate responsibility.
And then their recommendations go up further
up the line to executive committee, and things like
that.
I don't know the exact step at Community
Hospital. But, yes, it's incumbent on the QA
committee.
Q. All right. Do you know if Community at the time
had a utilization review committee?
A. I think that they did. But I'm not certain. I
think that they did.
Q. Do you know what a utilization review committee
does, generally, in a hospital?
A. Generally, yes.
Q. What does it do?
A. Well, utilization review makes sure that things are
done appropriately, and not -- not wasteful. They
oversee things to try and get patients out in a
timely fashion.
19 (Pages 73 to 76)
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They make sure documentation is there to
justify that the patient is in the hospital.
Basically, another step in seeing to a proper
medical practice.
Q. Would doing unnecessary surgery be wasteful?
A. Are you really asking me that?
MS. STANZIONE: Objection.
MR. CUTSHAW:
Q. Yeah.
THE WITNESS:
A. Yes, they would be.
MR. CUTSHAW:
Q. Thank you. These seven to 12 patients -- strike
that.
These seven of approximately 12 patients that
you reviewed, of cases that you reviewed, do you
know whether or not the hospital notified the
patients of your findings that you felt
approximately seven were unnecessary?
A. I do not know that.
Q. Would you expect the hospital to notify patients in
that situation?
A. Would I expect them to? That's is an interesting
question.
MS. STAMATAKOS: Objection, form.
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THE WITNESS:
A. It would be the right thing to do.
MR. CUTSHAW:
Q. Well, if you were a patient and you had an
unnecessary defibrillator placed by a doctor, and
the hospital knew about it, would you want to be
notified by the hospital of that situation?
MS. STANZIONE: Objection.
MS. DRENTH: Object to the form of the
question. You keep saying, "unnecessary," and I
think it misstates his prior testimony which was -THE WITNESS:
A. Outside of the guidelines.
MS. DRENTH: -- outside of the guidelines.
THE WITNESS:
A. Yes. If I received a device that was outside of
the guidelines, I would want to be notified.
MR. CUTSHAW:
Q. Well, your counsel talked about a little bit of
phraseology here, "outside of the guidelines" and
"unnecessary." Do you believe a procedure outside
the HRS guidelines or the Medicare guidelines, is
unnecessary?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. In my perception, in my belief, and the way that I
govern my practice, they are not to be done outside
of the guidelines.
And when I had to do one outside of the
guidelines, not only did I report myself, but I
went to Medicare, and sat down and demanded a fair
hearing. So, yes, I do believe it.
MR. CUTSHAW:
Q. Okay, thank you. I want to talk a little bit about
the circumstances of -- well, strike that.
Were you ever dismissed by the hospital as the
director of the EP lab?
MS. STANZIONE: Objection, form.
THE WITNESS:
A. I don't think that I was dismissed. I think when
my contract expired, because it was on a -- I can't
remember. A one or two or three year basis, they
just did not renew.
MR. CUTSHAW:
Q. Okay.
A. And I was not formally dismissed.
Q. Okay. Doctor, have you seen, in your practice,
former patients of Dr. Gandhi?
A. I have seen very few. Maybe one or two.
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Q. Did those patients have situations where you felt
that they had received an unnecessary implant?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. The two that I saw, no.
MR. CUTSHAW:
Q. Okay. In your view, is one unnecessary surgery too
many?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. In my view, yes.
MR. CUTSHAW:
Q. Well, we have heard testimony from Drs. Andress,
Drs. Kaufman, and Dr. Dasari, and including your
seven patients where you felt the indications were
outside the guidelines, that over 80 patients
received unnecessary or out of guideline
implantations. If that's true, does that concern
you?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. If that's true, it's a tragedy.
20 (Pages 77 to 80)
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MR. CUTSHAW:
Q. Why is it a tragedy?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. Eighty people outside of the guidelines. That's 80
surgeries that, in my opinion, weren't done
properly, for whatever reason.
MR. CUTSHAW:
Q. Can you conceive of any way that a doctor at
Community Hospital could get away with doing 80
unnecessary implantations?
MS. STANZIONE: Objection, form, move to
strike.
MS. DRENTH: I am just going to object to
speculation.
THE WITNESS:
A. Yes, I can't speculate on that. I can't conceive
how. I'm not going to answer that. That's pure
speculation.
MR. CUTSHAW:
Q. Okay. Dr. Kaufman testified in words or in
substance that he has heard of Dr. Gandhi calling
in patients for their six month angiogram. Have
you heard of that situation?
MS. STAMATAKOS: Objection, form.
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THE WITNESS:
A. I have heard of that, and I have experienced it.
MR. CUTSHAW:
Q. What do you mean, you have experienced it?
A. I had a patient that I saw, that got called in for
them.
Q. Is that inappropriate to do a regular angiogram
without the patient having symptoms, being
symptomatic?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. I don't -- I don't do angiography. So I am not the
expert on what is and isn't an appropriate
indication. There's a lot of things that go into
it.
But certainly if there is no symptoms, no
abnormal stress test, and no abnormal
documentation, such as EKGs, it should not be done
routinely.
MR. CUTSHAW:
Q. Is it an invasive procedure?
A. It is.
Q. And can you tell me briefly how that happens. Have
you seen one done?
MS. STAMATAKOS: Objection.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. How an angiogram is done?
MR. CUTSHAW:
Q. Yes, how it's done?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Form.
THE WITNESS:
A. An angiogram is done by a percutaneous puncture of
either the radial artery in the wrist, or the
femoral artery in the groin. Catheters are passed
over guidewires to the heart.
A catheter is passed into the heart to measure
left ventricular pressure, and to do what's called
a left ventriculogram, where you fill up the
ventricle with contrast to see how the ventricle
squeezes.
And then selective coronary angiography is
performed by again passing catheters up into the
right and left coronary artery and injecting them
at several views.
It is a very invasive procedure.
Q. Dr. Dasari, do you know Dr. Dasari?
A. He is my partner, I hired him.
Q. He testified in words or substance that a former
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patient of Dr. Gandhi who had a stent placed,
when -- had a stent placed, when the angiogram did
not show a lesion or blockage where the stent was
placed.
Do you have any situations where you believe
that there was excessive or improper stenting by
Dr. Gandhi, or anybody in his group?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. I have not seen that firsthand.
MR. CUTSHAW:
Q. All right. Did you have any discussions with Dr.
Dasari about his experience with that?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. No.
MR. CUTSHAW:
Q. Dr. Dasari testified that he reviewed, in words or
substance, that he reviewed 40 cases, and found
that 85 percent of Dr. Gandhi's implants were
unnecessary.
Did you ever have any discussions with Dr.
Dasari about that review?
A. Implants, what are you speaking of?
MS. STAMATAKOS: Objection.
21 (Pages 81 to 84)
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MR. CUTSHAW:
Q. Defibrillators?
MS. STAMATAKOS: Same objection.
THE WITNESS:
A. I did not.
(Referred to previously marked Exhibit 6.)
MR. CUTSHAW:
Q. I am going to hand you what was previously marked
as Exhibit 6 in Dr. Andress' deposition. This is a
publication relative to rankings of Medicare
providers in Indiana. Have you ever seen that
document before?
A. I have seen it online.
Q. Any concerns to you regarding cardiologists who
have an average procedures per patient of 12, when
the average in the entire State of Indiana is
three?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. That's the average; that seems like heavy
utilization.
MR. CUTSHAW:
Q. What do you mean by that, heavy utilization?
A. A lot of procedures.
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Q. Any concerns if a doctor has such a heavy
utilization?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
MS. DRENTH: Calls for speculation.
THE WITNESS:
A. The concerns that I would have is, are there
alternative ways of treating other than
intervention. Like bypass surgery, medical
therapy. Was every intervention appropriate.
Those would be the concerns that I would think of.
MR. CUTSHAW:
Q. Okay. Dr. Andress testified in words or in
substance that providing a patient with an
unnecessary defibrillator implant is like giving
someone another new medical problem, as it requires
lifetime follow-up; do you agree with that?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. I agree with the statement.
MR. CUTSHAW:
Q. Dr. Kaufman testified in words or in substance that
putting BiVs in patients with normal
synchronization of the lower ventricles can cause
arrhthymias patients didn't have before; do you
agree with that?
MS. STANZIONE: Objection, form.
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. I agree with the statement, and I would like to
expound.
MR. CUTSHAW:
Q. Sure.
A. Recent data has shown that biventricular pacing of
patients with normal QRS complexes contributes to
cardiomyopathy.
Early data, we thought, and possibly one of
the temptations to do a device in someone with a
QRS of 115, instead of 120, we thought, "Well, it
won't hurt them. May help them, won't hurt them."
Newest data suggests, actually, that it will
hurt them, if it doesn't help them. Some will
benefit.
But there is way more to this than just the
QRS. But it's the only thing that we know of to
use as a criteria.
But for those that it doesn't benefit, it can
have significant deleterious effects in left
ventricular function.
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Q. When you say it can cause cardiomyopathy, is that a
weakness?
A. To worsen, yes. It's assumed that they have
cardiomyopathy, to begin with. A weakness of the
heart to begin with. That's why they got -- it can
contribute to worsen, if they do not meet the wide
QRS criteria.
Q. There has been testimony that Dr. Gandhi was named,
at some point in time, as director of the Community
EP lab. Is it your view that that is appropriate
for cardiologists to be a director of the EP lab?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. An electrophysiologist, in my opinion, should be
the director of the electrophysiology laboratory.
MR. CUTSHAW:
Q. Dr. Kaufman, do you know Dr. Kaufman?
A. Yes, I hired him, too. He's my partner.
Q. He testified in words or in substance that he, Dr.
Dixon, you?
A. That would be me.
Q. Dr. Andress, Dr. Jayakar, Dr. Llobet, Brian Decker,
and Nurse Atherton complained to the hospital
administration about many of the issues that we
have discussed today. Are you aware of those
22 (Pages 85 to 88)
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complaints?
MS. STANZIONE: Objection, form.
MS. DRENTH: I am just going to object to the
form of the question. It's very broad and vague.
You are talking about everything that's been stated
in the deposition today?
MR. CUTSHAW:
Q. Many of the issues that we have discussed. Have
you heard of those doctors or nurses complaining to
the hospital administration about Dr. Gandhi?
A. I can tell you that myself. Nurse Atherton, for
sure. Dr. Kaufman, yes. Who else did you state?
Q. Dr. Andress?
A. I can't -- I can't make a statement about Andress.
Q. Dr. Llobet?
A. I don't know that to be true.
Q. Dr. Jayakar?
A. I don't know.
Q. You said that you know for a fact that Nurse
Atherton complained to the hospital administration?
A. Yes.
Q. How do you know that?
A. Because she told me.
Q. What did she tell you that she complained about?
A. She told me that when we were asked to no longer
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screen his cases for appropriateness and criteria,
guideline following, that she expressed great
concerns that we were told not to follow anymore.
Q. Any other concerns that she communicated to the
hospital administration of which you are aware?
A. None other than I am aware.
Q. Have you heard from other cardiologists or EPs in
Lake County, have you heard them indicate to you
that they believe that Dr. Gandhi was doing
unnecessary defibrillator implants?
A. Cardiologists, or EPs? I have.
Q. And I think you told us earlier about some rumors
that you heard about some of these -- some of this
conduct; correct?
A. Yes.
Q. Is this -- I mean, from listening to Drs. Andress,
you, Dr. Kaufman, Dr. Dasari, it appears to me that
this is common knowledge in the medical community
in Lake County; is my impression incorrect?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. It appears to be common knowledge.
MR. CUTSHAW:
Q. Do you have any ideas to what the odds are that the
hospital doesn't know that this is going on?
A. I have no idea.
MS. STANZIONE: Objection, form. Move to
strike.
MR. CUTSHAW:
Q. Are you aware of Dr. Dasari trying to provide
credentialing criteria for lead extractions to
Community?
A. I am aware that he did that. Yes.
Q. Are you aware of the hospital's response?
A. I am not.
Q. Are you aware that he tried to get on a committee
at the hospital?
A. I am not.
THE VIDEOGRAPHER: We have five minutes before
I have to change the tape.
MR. CUTSHAW: All right.
Q. Dr. Kaufman talked about, in his deposition, Dr.
Gandhi doing a study for Medtronic regarding I-Link
monitors; are you aware of that?
A. I had heard from Dr. Kaufman that he did that
study.
Q. And were you aware that Dr. Kaufman had a patient,
or saw a patient where one was -- one of those
monitors were put in when the patient already had
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documented sustained heart rhythm problems?
MS. STAMATAKOS: Objection, form.
THE WITNESS:
A. I was unaware of that.
MR. CUTSHAW: Let's take a break. I am about
done.
THE VIDEOGRAPHER: This is the end of tape two
in the deposition of Mark Dixon, D.O. We are off
the record at 8:10 p.m.
(A short recess was had)
THE VIDEOGRAPHER: This marks the start of
videotape number three in the deposition of Mark
Dixon, D.O. We are on record at 8:15 p.m.
MR. CUTSHAW:
Q. Doctor, you talked a little bit about a study which
indicated that implantations outside of indications
can cause the patient to have increased
cardiomyopathy. Do you remember that statement?
A. Yes.
Q. Do you know where that study is, or who published
it, or when it came out?
A. Currently not published. Pending.
Q. Do you know who is doing it?
A. A group of cardiologists, electrophysiologists for
the NIH.
23 (Pages 89 to 92)
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Q.
A.
Q.
A.
Q.
If it is not published, how did you hear about?
We are a very small click.
Grapevine?
Grapevine. The electrophysiology grapevine.
All right. So are there any benchmark studies, or
reports as to the expected average number of
defibrillator implant per population, that you are
aware of?
A. I am certain that data exists. I am not familiar
with it.
Q. Okay. When you were doing -- let's break this down
to before 2002, when the BiV defibrillators were
approved by the FDA. How many pacemaker implants
would you do, on the average, every year or month,
however you can break it down?
A. Standard pacemakers?
Q. Yes.
A. Not biventricular?
Q. Yes.
A. On average of about anywhere from, this is going by
memory, five to seven per month.
Q. Okay. How about BiVs?
A. Biventricular pacemakers weren't approved until
biventricular defibrillators were.
Q. Okay. So after 2002, then, what was the average
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number of defibrillator implants that you did per
month, if you know?
A. They went up significantly. Fifteen to 20.
Q. A month?
A. Yes.
Q. Is that average pretty much the same today?
A. Pretty much, yes.
Q. You talked a little bit about your hearing
complaints by EPs and cardiologists about Dr.
Gandhi. What kind of complaints have you heard
personally?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. As I recall, most complaints centered around the
inappropriateness of implantations.
MR. CUTSHAW:
Q. And have those complaints been voiced to you over a
period of years, and if so, how long?
MS. STAMATAKOS: Objection, form.
MS. STANZIONE: Objection, form.
THE WITNESS:
A. Years, yes. Long term. Still ongoing.
MR. CUTSHAW:
Q. Still ongoing, okay. You indicated that Nurse
Atherton -- Atherton?
Atherton.
Atherton has been your nurse for 23 years; correct?
Yes.
Do you ever recall a time when the hospital
requested her to come in to give a statement to
hospital administration?
A. I am unaware of that.
MR. CUTSHAW: I don't have anything further at
this time. Thank you, Doctor for your time.
THE WITNESS: Thank you.
MS. STAMATAKOS: I have a few questions.
THE WITNESS: Of course, go ahead.
CROSS EXAMINATION
QUESTIONS BY MS. STAMATAKOS:
Q. Is Nurse Atherton still with you?
A. She is. She is not employed by me. She is at
LaPorte Hospital. She is employed by IU LaPorte.
Q. Are you employed by IU LaPorte?
A. I am not. I am employed -THE WITNESS: Am I supposed to volunteer this?
MS. STAMATAKOS:
Q. Who are you employed by?
A. Porter Hospital.
Q. Okay. So you are employed by Porter Hospital. And
A.
Q.
A.
Q.
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you mentioned that, as I am remembering, or if I
look at my notes correctly, you do most of your
work currently at IU Health LaPorte and Porter
Hospital, and some work at St. Mary Medical Center?
A. Yes.
Q. But the majority is at IU Health LaPorte and Porter
Hospital?
A. Correct.
Q. And you haven't been actively practicing at
Community Hospital for the past six years, or so?
A. At least.
Q. At least. And you mentioned that you stopped
practicing there because you moved your practice
more to the east?
A. Correct.
Q. Why was that?
A. No, I didn't move my practice to the east. I am
the doctor that gets called when new hospitals want
new programs formed.
So when Porter decided they wanted an
electrophysiology program, they called me and asked
me to come out and start it.
Q. And when did you start the electrophysiology
program at Porter?
A. I don't recall. Late '90s.
24 (Pages 93 to 96)
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Q. And what about at LaPorte?
A. 2008.
Q. Are cardiologists, are you aware of whether
cardiologists have privileges to implant
defibrillators at Porter Hospital?
A. At Porter Hospital, no. They do not.
Q. Have they ever been permitted to implant
defibrillators at Porter Hospital, to your
knowledge?
A. Never.
Q. What about LaPorte Hospital?
A. Never.
Q. Do you know currently what the credentials or
requirements are in order to implant defibrillators
at Community Hospital?
A. I do not right now. No.
Q. Do you know what they were when you last practiced
there, at least six years ago?
A. I think that I do, yes.
Q. And what is your understanding as to what those
requirements were?
A. Well, I don't know the exact numbers involved. But
the requirements when I left there, we continued to
recommend the requirements involved
electrophysiologists. I don't know that that's
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what they did.
Q. And I guess that's my question. Do you know
specifically -A. I don't.
Q. -- what the criteria were at Community for
implanting defibrillators?
A. No. I have lost that knowledge, because I haven't
been active there.
Q. Have you ever seen Dr. Gandhi's privileges file?
A. No.
Q. Have you ever seen the privileges file of any
cardiologist at Community Hospital?
A. No.
Q. Have you ever seen the privileges file of any
electrophysiologists at Community Hospital?
A. No.
Q. Do you know whether, during the time that you
practiced at Community, any of your fellow
electrophysiologists ever received any notification
from Community, that a certain percentage of their
defibrillator implants were out of guidelines?
A. I do not know that.
Q. Do you know whether any cardiologists received
similar communication?
A. I do not know that.
Q. When we talk about or use the term, "out of
guidelines," are you referring to HRS guidelines,
or CMS guidelines, or both?
A. HRS and CMS guidelines are coincident, very close.
Q. And is one set of guidelines more stringent than
the other?
A. Well, CMS pays the bills. So -Q. So they are more stringent?
A. Yes. They take the front and center, yes.
Q. As you sit here today, can you identify the
differences between the CMS guidelines and the HRS
guidelines?
A. They are very minimal. It is on the basis of width
of QRS complex, ten milliseconds difference.
That's it.
Q. You mentioned that you had reviewed
approximately -A. -- approximately.
Q. Approximately 12 cases?
A. Of his.
Q. Of Dr. Gandhi's?
A. Many others.
Q. Okay. Over what period of time, if you can recall?
A. I don't recall.
Q. Do you recall was it a six month period, was it a
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year period?
A. Between six and 12. That is an educated guess.
Q. That's fine. And I thought you said that, and
correct me if I am wrong, that these were not cases
that had been performed at Community Hospital, but
they had been performed at another institution?
A. No, they were at Community.
Q. So I misheard you. These were cases that had been
performed -A. Yeah.
Q. -- at Community Hospital, okay. And you mentioned
that you reported to the quality assurance
committee your concerns regarding indications?
A. Yes.
Q. And, again, when you say "indications," you mean
that they didn't comply -A. Fitting the guidelines.
Q. -- with either HRS or CMS guidelines?
A. Correct.
Q. Did you keep copies of any of the written reports
that you made?
A. From nine years ago, no.
Q. You never know.
A. I'm not sure if Community kept copies from nine
years ago.
25 (Pages 97 to 100)
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Q. Okay.
MR. CUTSHAW: I hope that they did.
MS. STAMATAKOS:
Q. When did -- you mentioned that Chris Atherton told
you that you were no longer to review the
indications for the implants?
A. Yes.
Q. Do you recall when that conversation occurred; can
you give me a year?
A. I can't give you a year. It was shortly after we
turned in the original 12 reviews, approximate 12
reviews.
Q. When you -- do you recall what data that you
reviewed for those 12 cases?
A. The standard of EKG QRS width, ejection fraction,
and, again, New York Heart Association Functional
Class, which it was stated by the doctor.
Q. So the New York Heart Association Functional Class
would be a clinical determination?
A. Correct.
Q. Do you recall with respect to each of those
approximate 12 cases, if you had the actual EKG?
A. Frequently not.
Q. And what about the, in terms of showing an ejection
fraction, would that study be an angiogram, or an
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echocardiogram?
A. It could be an angiogram, echocardiogram, or a
multiple gated acquisition scan.
Q. And do you recall for the approximate 12 cases if
you had the underlying study documenting the
ejection fraction?
A. Ejection fractions were often stated on the
worksheet, but not present. In other words, no. I
did not have the report often.
Q. Was the worksheet the ICD registry?
A. The worksheet that was constructed by ourselves
that stated -- the only thing that we asked the
physicians to state was New York Heart Association
Class, QRS width, and ejection fraction, and please
provide source documentation for the EKG and the
ejection fraction.
Q. In the approximate 12 cases that you reviewed, if
you did not see the source data, did you ask for
it?
A. Yes. And actually, I will expound on that. I went
and got it.
Q. Okay. Where did you get it from?
A. Medical records.
Q. Medical records. And was that something that you
could access electronically at Community Hospital?
A.
Q.
A.
Q.
A.
Q.
No.
How did you -Charts.
You pulled the charts?
Uh-huh.
Did you ever ask Dr. Gandhi for any copies of
medical records from his office?
A. I think -- I did not personally. I know for a fact
that Chris had requested from his office that those
records, those source documentations be provided.
Q. Do you recall, when you were reviewing the 12
cases, if you reviewed any records specifically
from his office?
A. I reviewed one or two from his office.
Q. And would those have been the objective test
results?
A. Those would have been the EKG and an interpreted
echo.
Q. And if I understand your testimony correctly, you
never served on any credentials committee at the
Community Hospital?
A. I don't recall.
Q. Not that you recall.
A. If I was named to a credentialing committee, I
didn't serve well. I would recall if I had served
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on it. So if I was on the committee, I never
showed up to the meetings, let's put it that way.
Q. You have mentioned a couple of times, the Heart
Rhythm Society Clinical Competency Statement -A. Uh-huh.
Q. -- which an alternate pathway was created for
cardiologists to implant defibrillators?
A. Correct.
Q. Within that competency statement, are you aware of
any specific representations that those -- that
alternate pathway applied only to remote or
underserved areas?
A. Within the statement -Q. Yes.
A. -- no.
Q. You talked about some of the complications that can
occur from defibrillator implants including death,
obviously. And pneumothorax infection, or needless
shock if they are not programmed appropriately. Do
you know if Dr. Gandhi ever had a patient die at
the time of a defibrillator implant?
A. Not at the time of surgery, I am not aware of any.
Q. Have you ever had a patient die during a
defibrillator implant?
A. During it, no.
26 (Pages 101 to 104)
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Q.
A.
Q.
A.
Q.
As a complication of a defibrillator implant?
Yes.
Approximately how many times?
Once.
Do you know if Dr. Gandhi ever suffered a
complication of a pneumothorax during a
defibrillator implant?
A. I don't know.
Q. Have you ever had that, experienced that
complication?
A. I have not.
Q. Do you know whether any of Dr. Gandhi's patients
ever experienced infection following a
defibrillator implant?
A. I don't know.
Q. Have any of your patients experienced infection -A. -- yes.
Q. Approximately how many?
A. Oh, gosh, I can't even speculate on that. I have
put in over 3,000 defibrillators. Probably five,
six.
Q. And do you know if any of Dr. Gandhi's patients
have had needless shocks from defibrillator
implants?
A. I don't know it firsthand.
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Q.
A.
Q.
A.
Q.
A.
You mentioned a Brad Knight?
Yes.
What is his specialty?
Cardiac electrophysiology.
And do you know where he works?
Well, he works now at Northwestern University. He
was the director of the electrophysiology program
at University of Chicago during the timeframe.
Q. Have you ever corresponded with Dr. Gandhi about
any his of his electrophysiology patients?
A. I have.
Q. Do you recall approximately how many times?
A. Just a couple. He consulted me on one or two
cases.
Q. And do you recall the facts surrounding the
consultation?
A. Yes. One was for a supraventricular tachycardia
that I performed ablation for him. The other one
was for a patient with a defibrillator who had
received multiple shocks, most appropriate. One or
two perhaps.
I won't say inappropriate, but as a
consequence of his ventricular tachycardia, had
rapid afib and got shocks for them.
Q. And he called you in for consultation to help
evaluate and treat that?
A. Yes.
Q. Which was appropriate; do you think that was
appropriate?
A. To consult me?
Q. Yes.
A. Absolutely.
Q. Do you have any knowledge of the number of
biventricular implantations that Dr. Gandhi
performed in 2002?
A. Biventricular pacers?
Q. Yes, sorry.
A. It's hearsay, but I heard approximately 70 to 75.
Q. In the year 2002?
A. I don't know that.
Q. Okay. That's what I am asking.
A. No. I am talking about a number that I heard that
he has done.
Q. Collectively over the years?
A. Yes.
Q. At Community Hospital?
A. Yes.
Q. What about CRT?
A. CRT?
Q. Pacemakers?
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A. Yes. That biventricular pacers are CRT.
Q. Okay. Let me backtrack, then. Are you aware of
the number of biventricular defibrillators that he
has done?
A. No, I am not.
Q. Okay. And the number, the 70 number would apply to
the -A. The biventricular pacemakers.
Q. -- biventricular pacemakers. So you don't know the
timeframe?
A. From the time that he was granted biventricular
pacing privileges, until the time basically that he
received his biventricular defibrillator.
Q. Do you know when he was granted privileges to do
biventricular pacemakers?
A. I don't.
Q. What about defibrillators?
A. I don't.
MS. STAMATAKOS: I have no further questions.
Just for the record, to the extent that there was
some standard of care testimony, we leave the
option open to reconvene to question him on those
opinions. That's just for the record.
MS. STANZIONE: I was going to make the same
statement for the record.
27 (Pages 105 to 108)
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MR. ROOTH: This has nothing to do with you.
THE WITNESS: You are bringing me back.
MR. CUTSHAW: At their cost.
THE WITNESS: I will show you, I will do
patients until 9:00 p.m. that night. I am just
kidding. I am just kidding.
CROSS EXAMINATION
QUESTIONS BY MS. STANZIONE:
Q. Dr. Dixon, just a few questions.
A. Oh, of course.
Q. Famous last words. You talked about the 12 patient
charts that you reviewed of Dr. Gandhi's patients.
Was that in your role as medical director that you
did that?
A. Yes.
Q. When was that?
A. I don't know.
Q. Uhm -A. It was shortly after he received his biventricular
device privileges.
Q. Okay. So 2005?
A. 'ish.
Q. What caused you to review those?
A. It was my duty as the medical director of the EP
lab to review all implants. I reviewed mine, Dr.
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Kaufman's, Dr. Suprenant's, Dr. Gandhi for
appropriateness.
Q. I think you testified that you reviewed many
physicians?
A. Yes.
Q. Have you ever reviewed any operative schedules or
procedure schedules at Community Hospital regarding
procedures that Dr. Gandhi was scheduled to
perform?
A. No.
Q. Have you, yourself, undergone proctoring for any
reason?
A. Proctoring for any reason, no.
Q. And I know that you testified that Dr. Gandhi had
not ever asked you to proctor him; correct?
A. Correct.
Q. Are you aware whether Dr. Gandhi asked any other
electrophysiologists to proctor him?
A. I am not aware for certain. But I heard that he
had talked with the Bump and Petropoulos group
about maybe being proctored.
Q. Do you know what their answer was?
A. I don't.
Q. Have you ever proctored a cardiologist for the
purpose of obtaining privileges to implant ICDs?
A.
Q.
A.
Q.
A.
I have not.
Would you?
Yes.
Under what circumstances?
If they fulfilled every one of those criteria by
the Heart Rhythm Society, I would be happy to
proctor them.
Q. If your understanding that this is not an
underserved area, that it has to be an underserved
area, would you ever proctor somebody around here?
A. Well, we can't proctor now. The window is closed
on that.
Q. Okay. Well, back then, then. Because you said -back then. Would you do it back then?
A. Back then, I would have considered it, sure.
Q. Okay.
A. If someone shows the initiative to go out and take
the conference, take the course, and is willing to
be proctored, yes, I would.
Q. Okay.
A. For primary prophylactic devices only.
Q. So do you believe that cardiologists should be able
to implant defibrillators?
A. Not today. Only the ones who may have made it in
the window.
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Q. Okay. And do cardiologists implant defibrillators
at any other institutions where you have
privileges?
A. At Methodist Hospital they do.
Q. Which one?
A. Southlake.
Q. Only Southlake?
A. Yes.
Q. And where else?
A. And St. Mary's has of this year, or maybe in the
last two years. I don't know that exactly.
Q. Any others that you know of?
A. No.
Q. How about any other hospitals that you maybe don't
have privileges, but you happen to know that they
credential cardiologists?
A. Well, obviously we know that St. Margaret's does.
St. Anthony's in Crown Point does not. The South
Bend Memorial Hospitals do not. The Goshen
Hospital does not. No, that's it. That's what I
know.
Q. All right, thank you. Do you happen to know if any
hospitals that you listed that do credential
cardiologists to implant defibrillators, have
credentialing guidelines that match those proposed
28 (Pages 109 to 112)
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by the Heart Rhythm Society?
A. Methodist Southlake does, as does St. Mary's.
Q. What about St. Margaret's?
A. I don't know anything about St. Margaret's. I have
never been on staff there.
Q. Were there any others that you mentioned?
A. Those are the only ones.
Q. That's what I thought. You would agree that the
Heart Rhythm Society is not a credentialing body,
though; right?
A. They are not a credentialing body.
Q. Have you -- you may have testified to this, but I
was unclear if you were talking about CMS or Heart
Rhythm Society. Have you implanted an ICD in a
patient that did not meet the requirements of
either the CMS or the National Heart Rhythm
Society?
A. Both.
Q. Both. On separate occasions, or -A. No, one patient.
Q. -- for both. Okay.
A. Please ask me to expound on that.
Q. No, that's okay. I don't want to be here all
night.
A. It will only take a minute. No, I'm just kidding.
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Q. Has the hospital quality review committee ever
reviewed your medical records -- your medical
records -MS. STANZIONE: Why are you laughing?
Q. -- related to documenting the indications for
implantation?
A. Has the hospital what?
Q. Has the hospital quality review committee ever
reviewed your records related to documenting the -A. I wouldn't know that. I have never been notified
that they have.
Q. You never got a letter, or anything like that?
A. Not that I am aware of. No.
Q. Okay.
A. I have, however, reviewed my own.
Q. Okay. For what purpose?
A. I am the director. I am as responsible as the next
guy.
Q. The same reason as everybody else?
A. Uh-huh.
Q. Okay. Have you ever made any recommendations to
the credentialing committee at Community Hospital
regarding physician privileges of any particular
individual?
A. Say that again.
Q. Have you ever made any recommendations to a
credentials committee at Community Hospital
regarding privileges to be gained by a particular
physician?
A. Not that I am aware of.
Q. You testified that you served as medical director
of the EP at Community from approximately 1994 to
approximately 2008?
A. Yes.
Q. Did you simultaneously serve in the same medical
director position at St. Catherine Hospital and St.
Mary's?
A. I did, yes. If you notice my note, it says
regional director of the -Q. That's what I saw, yeah.
A. Yes.
Q. So that's what that means?
A. Yes.
Q. So it was a system-wide position?
A. Correct.
Q. What percentage of time did you spend at each
hospital performing those services?
A. As the medical director?
Q. Yes.
A. Probably 60 percent at St. Mary's, 30 percent at
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Munster, and 10 percent at St. Catherine's,
roughly.
Q. Okay. In your capacity as the medical director, did
you ever review the credentialing standards for ICD
implantation at Community?
A. I don't think that I ever knew what Community came
up with for their final, who can and who can't.
Q. Okay. So you never had any part in writing or
revising the credentialing standards at Community?
A. I don't think so, no.
Q. And if you served on a credentialing committee, you
don't remember?
A. If I did, I didn't go to any meetings.
Q. Okay. Have you served on a credentialing committee
on any other hospital?
A. No.
Q. Okay. Have you served on any committees at
Community Hospital before?
A. No.
Q. How about any other hospitals?
A. Yes. Yes, I have. At St. Mary's, I served on -- I
was an advisor to the pharmacy in therapeutics
committee. I wasn't actually on the committee, but
I was a medical advisor to them.
Q. And when was that?
29 (Pages 113 to 116)
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A. I don't know. Many years ago.
Q. Have you served on any actual committees at any
hospital? At any hospital?
A. No. Not that I am aware of, no.
Q. Okay. So is it safe to say that you don't have any
knowledge, then, about how the credentialing
standards were developed at Community Hospital in
2001, or -- yes, 2001?
A. I think that's safe to say.
Q. And the same for 2005?
A. I think that's safe to say.
Q. And the present?
A. (Witness nods).
Q. Was your partner, Dr. Suprenant, on the committee
to develop the standards, do you know?
A. Dr. Suprenant is not my partner.
Q. He was never your partner?
A. Never.
Q. Are you aware if he was on one of the committees?
A. I heard that he was, but I don't know that.
Q. Have you been asked to offer any opinions or
comments on Dr. Gandhi's background, training,
knowledge, skill by anybody at the hospital,
Community Hospital?
A. No.
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from both sides. He explained that there would be
representation for Dr. Gandhi and for Community
Hospital, as well as his side of the table.
Q. Did you discuss the substance of your testimony in
any way?
A. I asked him if it was about the appropriateness of
his device implantations. And he said it may come
up.
Q. Was there anything else about the substance?
A. Not that I can recall.
Q. Okay. Do you know Raymond Kammer?
A. Raymond Kammer, no.
Q. Do you know Gloria Sargent?
A. I do.
Q. In what capacity?
A. I saw her briefly covering my partner one day. I
know their cases both, though.
Q. Why is that?
A. Because my group runs a group practice. And if one
of us has a concern or a question, we get multiple
opinions from ourselves.
Q. Have you ever reviewed any cases, as like an expert
witness, for any of the attorneys for the
plaintiffs in this case?
A. Expert witness for any of the attorneys for the
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Q. Other than your own attorney, have you spoken with
any attorneys regarding the contents of the facts
involved in the federal case, or in the case that
we are here on today?
A. I spoke with Attorney Hawkins briefly.
Q. When was that?
A. When he contacted me about the deposition.
Q. And what did you discuss with him?
A. I discussed with him what would be asked of me,
what is expected of me.
Q. How long was that conversation?
MR. HAWKINS: Sorry, I can't help you.
THE WITNESS:
A. That was 10, 15 minutes.
MS. STANZIONE:
Q. And where did that take place?
A. On my cellphone while I was pulling weeds in my
front yard.
Q. And who was -- was anybody else privy to that phone
call?
A. No, the weeds were.
Q. What did he explain to you as to what would be
expected of you at the deposition?
A. He explained that I should tell the truth,
obviously. He explained that questions would come
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plaintiffs? No.
Have you ever given a deposition before today?
Yes.
How many times?
Several.
In what capacity, as an expert witness?
Once as expert witness. No, twice as expert
witness. I went to court several times as expert
witness.
Q. Have you done so in a medical malpractice lawsuit
against you?
A. No.
Q. Have you done so in any medical malpractice lawsuit
at all?
A. Yes.
Q. In what capacity?
A. I was the expert witness for the plaintiff.
Q. Have you testified at trial?
A. I did.
Q. How many times?
A. One time.
Q. And do you remember the attorneys involved in that
case?
A. I do.
Q. Who are they?
Q.
A.
Q.
A.
Q.
A.
30 (Pages 117 to 120)
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A. I can remember one. It is -Q. Or the name of the case. I mean, I am just trying
to find a way, if need be, to -- your prior
testimony, whether it be deposition or trial?
A. Oh, okay. One is Elizabeth Stryczek versus Bharat
Barai. Who is the guy on Highway 30, the
malpractice attorney?
Q. Tim Schafer?
A. Tim.
Q. Okay. You don't expect hospitals to review every
case prior to you doing surgery to determine if
it's medically necessary, do you?
A. No. I expect that every case be reviewed
postsurgery.
Q. And that's what you did as medical director?
A. Correct.
Q. Okay.
A. It would not be feasible to do it pre.
MS. STANZIONE: I have no further questions.
REDIRECT EXAMINATION
QUESTIONS BY MR. CUTSHAW:
Q. Doctor, I am just going to try to be brief, but do
some follow-up questioning. Have you talked to any
of the lawyers for the defense before today?
A. No.
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Q. Regarding this deposition?
A. No.
Q. You talked about a worksheet that was drafted at
Community Hospital, and that's mentioned on page
three of this Plaintiff's Exhibit 1, Brian Decker's
statement. It says the worksheet was developed for
documenting indications for ICD implantation?
A. Correct.
Q. Did you have a role in drafting that worksheet?
A. I did.
Q. Did you do it in conjunction with Brian Decker?
A. No, I told Chris what needed to be on it. The
three indications, the recognized indications.
Q. Okay. And so did Chris actually do the drafting?
A. I don't know if she or Brian did. But I'm certain
that they corroborated.
Q. You indicated that you didn't know firsthand if any
of Dr. Gandhi's patients got inappropriate shocks
after implants. You said that you knew -- you
implied secondhand, you might know. What
secondhand do you know?
A. No. What I meant was, the definition of
inappropriate. When a patient has a bunch of
ventricular arrhythmia, and they get shock after
shock, life saving appropriate shocks, sometimes
their upper chambers go out of rhythm into
fibrillation, which makes the heart go fast, so
they get another shock.
I witnessed that personally. But technically
it is an inappropriate shock, because it is for
atrial fibrillation.
But it is a very common inappropriate shock.
In other words, there was no -- nothing done wrong
to account for that shock.
Q. I see. You indicated that you would be willing to
expand on the one implant that you turned yourself
in on that was outside of the guidelines, and I
would like you to do so, sir.
A. Okay, thank you. I will do it quickly. So one of
the guidelines is a patient should not receive a
device within 90 days of diagnosis of their new
cardiomyopathy.
Q. Without medical therapy?
A. Without medical therapy, yes. But not within 90
days of diagnosis of the new cardiomyopathy, and
not for 90 days after revascularization.
I had a patient who went to open heart surgery
with an ejection fraction of 30 percent. It
appears that they had a myocardial preservation
problem intra-op, because he came out with an
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ejection fraction of 12 percent, fulminant heart
failure, on a balloon pump, on a ventilator, and
unable to come off of the balloon pump.
He had a very wide left bundle branch block
postoperatively, that he didn't have
preoperatively, as well as a severe delay between
the upper and lower chambers.
So technically I was not to implant the
biventricular device for 90 days. The problem is,
the guy's options were die, get a biventricular
defibrillator, or go down to one of the
universities for either an LVAD or a heart
transplant.
I presented the data to the family. I
explained to the family that the chances are good
that Medicare may fight us on this. But if it were
me, I would take this incision, over another one of
these incisions, any time (indicating).
I put it in the patient, flew off the
ventilator, flew off the balloon pump, left the
hospital nine days later.
The biventricular device not only saved his
life from a lethal arrythmia, but improved his
heart failure significantly. He is alive today.
I turned it in because I violated the
31 (Pages 121 to 124)
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indication. And I contacted my local Medicare
provider and explained the thing.
I had to go physician-to-physician in a
conference. And they rousingly were in support of
me, because we are talking about a $35,000 device
versus a 350 to $500,000 device. And thanks for
asking.
Q. Sure. You talked a -- you talked a little bit
about situations where the QRS may have been
overstated. In any of the cases that you reviewed
of Dr. Gandhi's, did you ever see any misstatement,
or an inaccurate statement as to the ejection
fraction?
MS. STANZIONE: Objection, form.
THE WITNESS:
A. Yeah. I can't answer that, because I did not
personally review the echocardiograms. In other
words, I did not play the tape and measure an EF,
myself. That would not be for me to do.
If there was a source document that it was
read as 35 percent, it was assumed that it was 35
percent.
In other words, we want to try to believe in
the integrity of the reading physician. I mean, in
a perfect world, someone who is not implanting,
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would read the study.
But it's not a perfect world. I do want to
make one other statement about the QRS complex.
Q. Sure.
A. The computer is not a sine qua non on a QRS. It
misses often. Computers will read 110 sometimes.
And if you read it out in several leads, it's 120
in many leads. And so I look for that, as well.
Trying to look for the benefit of the doubt.
Q. So you were trying to be very thorough when you
looked -A. Yes.
Q. -- at those approximate seven of 12 cases?
A. Correct.
Q. Have you ever attended a hospital meeting where
other doctors voiced concerns about Dr. Gandhi?
A. A hospital meeting?
Q. Yes.
A. No.
MR. CUTSHAW: I have nothing further. Thank
you, Doctor.
RECROSS EXAMINATION
QUESTIONS BY MS. STAMATAKOS:
Q. Two follow-ups. You said that you never attended a
hospital meeting where concerns were expressed.
Did you ever confer with any of your fellow
electrophysiologists, in which you expressed
concerns regarding Dr. Gandhi's -A. They were expressed to me.
Q. By your partners?
A. My partners, Dr. Andress, Dr. Mitchell.
Q. And was there any -- ever any discussion about
trying to do something at the administrative level
to have Dr. Gandhi's privileges revoked or
suspended?
A. Not that I am aware of. I certainly never
volunteered that.
Q. Are you being compensated for your deposition
today?
A. I am.
Q. Do you know how much?
A. I think $500 an hour. If you call me back, it's
800.
MS. STAMATAKOS: I have nothing further, then.
MS. STANZIONE: Nothing further.
THE WITNESS: I am just messing with you.
MS. STAMATAKOS: I figured, okay.
REDIRECT EXAMINATION
QUESTIONS BY MR. CUTSHAW:
Q. You talked about the computer anomaly with respect
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to QRS's can occur. When you were doing those
investigations, did you find any anomalies?
A. No.
MR. CUTSHAW: Nothing further.
MS. DRENTH: We will read and sign.
THE VIDEOGRAPHER: This marks the end of the
deposition of Mark Dixon, D.O., and we are off the
record at 8:54 p.m.
(The deposition concluded at 8:54 p.m.)
32 (Pages 125 to 128)
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STATE OF INDIANA )
)SS:
COUNTY OF LAKE )
IN THE LAKE CIRCUIT COURT
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GLORIA SARGENT,
)
)
Plaintiff,
)
)
vs.
) Cause No.
) 45C01-1404-CT-0049
ARVIND N. GANDHI, M.D.,
)
CARDIOLOGY ASSOCIATES OF
)
NORTHWEST INDIANA, P.C.,
)
and MUNSTER MEDICAL
)
RESEARCH FOUNDATION, INC., )
d/b/a COMMUNITY HOSPITAL, )
)
Defendants.
)
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Job No. 91840
I, MARK ALAN DIXON, D.O., state that I have
read the foregoing transcript of the testimony
given by me at my deposition on September 3, 2014,
and that said transcript constitutes a true and
correct record of the testimony given by me at said
deposition except as I have so indicated on the
errata sheets provided herein.
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Page 131
____________________________________
MARK ALAN DIXON, D.O.
STEWART RICHARDSON & ASSOCIATES
Registered Professional Reporters
150 West Lincolnway, Suite 1005
Valparaiso, IN 46383
(219) 462-3436
25
IN WITNESS WHEREOF, I have hereunto set my
hand and affixed my notarial seal this 11th day of
September, 2014.
________________________________
Carol A. Byrd, CSR
084.003188
Notary Public - State of Indiana
My Commission Expires: 5-31-2015
Job No. 91840
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Page 132
STATE OF INDIANA )
)
COUNTY OF LAKE )
1
I, Carol A. Byrd, CSR, a Notary Public in and
for said county and state, do hereby certify that the
deponent herein, MARK ALAN DIXON, D.O., was by me
first duly sworn to tell the truth, the whole truth,
and nothing but the truth in the aforementioned
matter;
That the foregoing deposition was taken on
behalf of the Plaintiff; that said deposition was
taken at the time and place heretofore mentioned
between 6:09 p.m. and 8:54 p.m.;
That said deposition was taken down in
stenograph notes and afterwards reduced to typewriting
under my direction; and that the typewritten
transcript is a true record of the testimony given by
said deponent;
And thereafter presented to said witness for
signature; that this certificate does not purport to
acknowledge or verify the signature hereto of the
deponent.
I do further certify that I am a disinterested
person in this cause of action; that I am not a
relative of the attorneys for any of the parties.
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(Originating Party)
MR. DAVID J. CUTSHAW, ESQ.
MR. GABRIEL A. HAWKINS, ESQ.
COHEN & MALAD, LLP
One Indiana Square, Suite 1400
Indianapolis, Indiana 46204
NOTICE OF DEPOSITION SUBMISSION
JOB NO. 91840
IN THE LAKE CIRCUIT COURT,
CAUSE No. 45C01-1404-CT-0049
GLORIA SARGENT, Plaintiff,
v.
ARVIND N. GANDHI, M.D., CARDIOLOGY ASSOCIATES OF
NORTHWEST INDIANA, P.C., and MUNSTER MEDICAL RESEARCH
FOUNDATION, INC., d/b/a COMMUNITY HOSPITAL,
Defendants.
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In compliance with all applicable rules,
you are notified the signed original deposition of
MARK ALAN DIXON, D.O. has been sealed and submitted
to the originating party.
__________________________________________________
(Date of submission or mailing by certified mail)
cc: Ms. Stamatakos, Esq.
Ms. Sharon Stanzione, Esq.
Ms. Marian C. Drenth, Esq.
STEWART RICHARDSON & ASSOCIATES
Registered Professional Reporters
150 West Lincolnway, Suite 1005
Valparaiso, IN 46383
(219) 462-3436
25
33 (Pages 129 to 132)