·1· · · UNITED STATES PATENT AND TRADEMARK OFFICE
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`·2· · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`·3· ·EDWARDS LIFESCIENCES· · ·)
`· · ·CORP., EDWARDS· · · · · ·)
`·4· ·LIFESCIENCES LLC, AND· · )
`· · ·EDWARDS LIFESCIENCES AG· )
`·5· · · · · · · · · · · · · · )
`· · · · · · · ·Petitioners,· ·)
`·6· · · · · · · · · · · · · · ) CASE IPR
`· · ·v.· · · · · · · · · · · ·) 2017-00060
`·7· · · · · · · · · · · · · · )
`· · ·BOSTON SCIENTIFIC· · · · )
`·8· ·SCIMED, INC.,· · · · · · )
`· · · · · · · · · · · · · · · )
`·9· · · · · · ·Patent Owner· ·)
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`11· · · · · · ·Deposition of NIGEL P. BULLER, M.D.,
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`12· ·taken pursuant to notice, at the law offices
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`13· ·of Morris Nichols Arsht & Tunnell, LLP 1201
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`14· ·Market Street, Wilmington, Delaware, beginning
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`15· ·at 8:40 a.m., on Thursday, June 15, 2017,
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`16· ·before Terry Barbano Burke, RMR-CRR and Notary
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`17· ·Public.
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`Page 001 of 199
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`·2· · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`·3· ·EDWARDS LIFESCIENCES· · ·)
`· · ·CORP., EDWARDS· · · · · ·)
`·4· ·LIFESCIENCES LLC, AND· · )
`· · ·EDWARDS LIFESCIENCES AG· )
`·5· · · · · · · · · · · · · · )
`· · · · · · · ·Petitioners,· ·)
`·6· · · · · · · · · · · · · · ) CASE IPR
`· · ·v.· · · · · · · · · · · ·) 2017-00060
`·7· · · · · · · · · · · · · · )
`· · ·BOSTON SCIENTIFIC· · · · )
`·8· ·SCIMED, INC.,· · · · · · )
`· · · · · · · · · · · · · · · )
`·9· · · · · · ·Patent Owner· ·)
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`10
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`11· · · · · · ·Deposition of NIGEL P. BULLER, M.D.,
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`12· ·taken pursuant to notice, at the law offices
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`13· ·of Morris Nichols Arsht & Tunnell, LLP 1201
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`14· ·Market Street, Wilmington, Delaware, beginning
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`15· ·at 8:40 a.m., on Thursday, June 15, 2017,
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`16· ·before Terry Barbano Burke, RMR-CRR and Notary
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`17· ·Public.
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`Page 001 of 199
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`·1· ·APPEARANCES:
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`·2· · · · BRIAN P. EGAN, ESQUIRE
`· · · · · MORRIS NICHOLS ARSHT & TUNNELL LLP
`·3· · · · · 1201 North Market Street
`· · · · · · Wilmington, Delaware 19801
`·4· · · · · · · · · · · · -and-
`· · · · · GREGORY S. CORDREY, ESQUIRE
`·5· · · · JEFFER MANGELS BUTLER & MITCHELL, LLP
`· · · · · · 3 Park Plaza - Suite 1100
`·6· · · · · Irvine, California· 92614
`· · · · · · For the Petitioner
`·7
`· · · · · MARC A. COHN, ESQUIRE
`·8· · · · EDWARD HAN, ESQUIRE
`· · · · · ARNOLD & PORTER/KAYE SCHOLER
`·9· · · · · 601 Massachusetts Avenue, NW
`· · · · · · Washington, DC· 20001-3743
`10· · · · · For the Patent Owner
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`11· ·ALSO PRESENT:
`· · · · · VICTORIA BROWN, Legal Intern
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`· · · · · · · · · · · -· · ·-· · ·-
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`14· · · · · · · · · ·NIGEL P. BULLER, M.D.,
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`15· · · · the deponent herein, having first been
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`16· · · · duly sworn on oath, was examined and
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`17· · · · testified as follows:
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`18· ·BY MR. COHN:
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`19· · · ·Q.· Good morning, Dr. Buller.
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`20· · · ·A.· Good morning.
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`21· · · ·Q.· You submitted an expert report in this
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`22· ·inter partes review proceeding; is that right?
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`23· · · ·A.· Yes.
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`24· · · ·Q.· An expert declaration?
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`Page 002 of 199
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`·1· · · ·A.· That's why I was hesitating.· Yes, I
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`·2· ·think it was a declaration.
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`·3· · · ·Q.· And you signed that declaration under
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`·4· ·oath to give the truth and nothing but the
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`·5· ·truth so help you God in that declaration; is
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`·6· ·that right?
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`·7· · · ·A.· Yes, correct.
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`·8· · · ·Q.· Now, you also gave testimony recently
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`·9· ·in a United Kingdom litigation about the
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`10· ·European counterpart to the patent that is at
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`11· ·issue in this inter partes proceeding; is that
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`12· ·right?
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`13· · · · · · · · ·MR. EGAN:· Objection.
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`14· ·Relevance.
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`15· · · · · · · · ·THE WITNESS:· Earlier this year.
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`16· ·BY MR. COHN:
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`17· · · ·Q.· That was January this year; correct?
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`18· · · ·A.· Correct.
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`19· · · ·Q.· And in that proceeding, you swore to
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`20· ·tell the truth so help you God, is that right,
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`21· ·when you testified in court?
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`22· · · ·A.· Yes.
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`23· · · ·Q.· And the oath that you took in that
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`24· ·proceeding, you take that oath as seriously as
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`Page 003 of 199
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`·1· ·you took the oath that you just gave this
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`·2· ·morning; is that right?
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`·3· · · ·A.· Of course, yes.
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`·4· · · ·Q.· And you stand by your testimony in the
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`·5· ·UK in January?
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`·6· · · ·A.· I do.
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`·7· · · ·Q.· Is there anything that you recall
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`·8· ·saying in that proceeding that you want to
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`·9· ·correct or clarify right now?
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`10· · · ·A.· Not as I sit here.· I mean I may have
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`11· ·misspoken.· I hope I would have corrected it
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`12· ·at the time if I said the wrong words, because
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`13· ·I do remember something got mixed up.
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`14· · · · · · · · ·But, no, essentially I'm
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`15· ·sticking completely behind the testimony I
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`16· ·gave.· But wrong words and things, I might
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`17· ·have misspoken.
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`18· · · ·Q.· How many depositions have you given in
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`19· ·the last five years?
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`20· · · ·A.· I honestly don't know.· Half a dozen.
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`21· ·Half a dozen, I would guess.· There were no
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`22· ·depositions for the UK case.· The only
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`23· ·depositions I've given are in the US.
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`24· · · ·Q.· When you say "in the US," you mean for
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`Page 004 of 199
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`·1· ·proceedings in the United States?
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`·2· · · ·A.· I mean both in the United States and
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`·3· ·court procedures.· I haven't done any
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`·4· ·depositions outside the United States, but,
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`·5· ·yes, being full proceedings in the United
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`·6· ·States.
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`·7· · · ·Q.· How many of those depositions were in
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`·8· ·your capacity as an expert for Edwards Life
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`·9· ·Sciences?
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`10· · · ·A.· Several of them.· In the last five
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`11· ·years, I believe I've only acted for two
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`12· ·companies.· One is CR Bard.· And there was a
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`13· ·trial earlier this year against Gore, and for
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`14· ·that I gave -- I can't remember if it was one
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`15· ·or two depositions, but I certainly did a
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`16· ·deposition.· And then I gave live testimony
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`17· ·here in Delaware earlier this year.
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`18· · · · · · · · ·And the other ones are, to the
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`19· ·best of my recollection, all for Edwards.
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`20· · · ·Q.· What was the subject matter?· And let
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`21· ·me just preface this by saying I don't want
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`22· ·you to reveal any confidential information of
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`23· ·Bard or the parties in that case, but what was
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`24· ·the general subject matter of the testimony
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`Page 005 of 199
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`·1· ·you gave in the Bard case?
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`·2· · · ·A.· About ePTFE to cover stents.· So it's
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`·3· ·about what is often called Gortex.· It's a
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`·4· ·tradename for Gore, and it was about ePTFE
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`·5· ·thickness or covering stent grafts.
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`·6· · · ·Q.· Did you represent the patent owner in
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`·7· ·that case?
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`·8· · · ·A.· No.· The patent owner was Gore and
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`·9· ·they were suing Bard, CR Bard for
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`10· ·infringement, and I was acting for Bard saying
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`11· ·the patent was invalid and not infringed.· And
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`12· ·this was in Delaware a few months back.
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`13· · · ·Q.· Did your testimony discuss the Gore
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`14· ·extruder?· Is it called the extruder?
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`15· · · ·A.· No, excluder.· If that is what you
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`16· ·mean.
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`17· · · ·Q.· I misspoke.
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`18· · · ·A.· The AAA device.
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`19· · · ·Q.· Let me ask a clean question.
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`20· · · · · · · · ·Did your testimony for Bard at
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`21· ·the trial earlier this year in Delaware cover
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`22· ·the Gore excluder?
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`23· · · ·A.· No.
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`24· · · ·Q.· Did you discuss in that testimony any
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`·1· ·of the prior art that you have discussed in
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`·2· ·your declaration in this inter partes review?
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`·3· · · ·A.· No.· I don't believe as I sit here,
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`·4· ·but, obviously, there are a lot of documents.
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`·5· ·I don't believe so.
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`·6· · · · · · · · ·By prior art, I'm sorry, can I
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`·7· ·correct that?· There were a few general
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`·8· ·medical references, things like Lawrence,
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`·9· ·which is something I talked about.· I think
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`10· ·was talked about
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`11· · · · · · · · ·There are a few, obviously my
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`12· ·background as an interventional cardiologist,
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`13· ·there's things in that, medical things.· But
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`14· ·the patents, the prior art, were not the same
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`15· ·as in this case.
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`16· · · ·Q.· Roughly, what was the priority date in
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`17· ·the Gore case, the Bard/Gore case?
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`18· · · ·A.· Much earlier.· Approximately ten years
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`19· ·earlier, I think, from memory.· I may be wrong
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`20· ·on this.· It was around '93.
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`21· · · ·Q.· In your capacity as an expert for
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`22· ·Edwards in this inter partes reviews
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`23· ·proceeding, are you being compensated?
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`24· · · ·A.· Yes.
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`·1· · · ·Q.· Are you being compensated on an hourly
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`·2· ·basis?
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`·3· · · ·A.· Yes.
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`·4· · · ·Q.· What is your hourly rate?
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`·5· · · ·A.· Pound sterling, 480 pounds.· I charge
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`·6· ·and am paid in sterling.
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`·7· · · ·Q.· Are you being paid by the hour for
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`·8· ·today's testimony?
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`·9· · · ·A.· Yes.
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`10· · · ·Q.· Same rate?
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`11· · · ·A.· Yes, exactly the same.
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`12· · · ·Q.· Over the past five years,
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`13· ·approximately how much compensation have you
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`14· ·received from Edwards Lifesciences for all of
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`15· ·your expert work for them?
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`16· · · ·A.· I honestly don't know.
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`17· · · ·Q.· Within 500,000 pounds?
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`18· · · ·A.· Yes, I think probably more than
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`19· ·500,000 pounds, but I haven't added it up.
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`20· · · ·Q.· Let's just establish some quick
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`21· ·shorthands, mostly for the court reporters.
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`22· · · · · · · · ·The patent at issue in this
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`23· ·inter partes review proceeding, can we call it
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`24· ·the '608 patent?
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`Page 008 of 199
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`·1· · · ·A.· Yes.
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`·2· · · ·Q.· And you understand what patent I am
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`·3· ·talking about?
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`·4· · · ·A.· I do.· I mean it is obviously the one,
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`·5· ·if you give me a copy, there will be no -- but
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`·6· ·yes, it is the '608.· I have been in a case
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`·7· ·where there was another patent with the same
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`·8· ·numbers, but I know exactly what you are
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`·9· ·talking about, and I am talking about the '608
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`10· ·patent.
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`11· · · ·Q.· The acronym T-A-V-R, TAVR, just for
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`12· ·the record, what does that stand for?
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`13· · · ·A.· Transluminal aortic valve replacement.
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`14· · · ·Q.· Can we also call it transcatheter
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`15· ·aortic valve replacement?
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`16· · · ·A.· Yes, you can.
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`17· · · ·Q.· That is an equally valid
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`18· ·interpretation of that acronym, transluminal
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`19· ·versus transcatheter?
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`20· · · ·A.· Yes, yes.· But the A, you gave the
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`21· ·acronym, I thought you said "A", T-A-V-R.
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`22· · · ·Q.· T-A-V-R?
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`23· · · ·A.· Yes.
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`24· · · ·Q.· So the "T" can be either transluminal
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`·1· ·or transcatheter, it doesn't matter?
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`·2· · · ·A.· Yes.
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`·3· · · ·Q.· And TAVI, what does that mean?
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`·4· · · ·A.· Just change the replacement for
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`·5· ·implantation.· Again, it's essentially the
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`·6· ·same.· It's a slightly different acronym.
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`·7· ·There are a whole range of these acronyms
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`·8· ·which are used interchangeably for the same
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`·9· ·sort of procedure.· Transcatheter aortic valve
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`10· ·replacement is probably one of the more common
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`11· ·ones.
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`12· · · ·Q.· TAVR and TAVI are used interchangeably
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`13· ·for essentially the same procedure?
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`14· · · ·A.· I think they are, yes.
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`15· · · ·Q.· Today can we just use TAVI?
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`16· · · ·A.· I'm happy.
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`17· · · ·Q.· Generally speaking, what is a TAVR
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`18· ·procedure?
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`19· · · ·A.· Today, or meaning as of today?
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`20· · · ·Q.· Yes.
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`21· · · ·A.· It's a procedure in which a
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`22· ·replacement valve is put inside the body,
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`23· ·typically into the heart, using a catheter and
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`24· ·is most often used to treat aortic stenosis.
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`Page 010 of 199
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`·1· ·So that's the most common TAVR procedure.
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`·2· ·There are other ones used in other locations.
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`·3· · · ·Q.· Like in the pulmonic valve, for
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`·4· ·example?
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`·5· · · ·A.· Yes.· The device, if you like, even
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`·6· ·though it is called aortic, they are
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`·7· ·occasionally put in other places and inside
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`·8· ·other valves.· But the vast majority of them
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`·9· ·are put in to replace aortic valves in
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`10· ·patients that have degenerative process and
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`11· ·old age referred to as calcific stenosis.
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`12· ·That would be the majority of ones that are
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`13· ·done today.
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`14· · · ·Q.· Now, when I asked you what is a TAVR
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`15· ·procedure and you said, you asked me when I
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`16· ·was referring to, would your definition change
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`17· ·if I had said what is a TAVR procedure in
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`18· ·2004?
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`19· · · ·A.· Well, yes, because by then it wasn't
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`20· ·commercialized, and I would probably talk
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`21· ·about the very few individuals you had
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`22· ·experience of, and most notably Alain Cribier.
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`23· ·A-L-A-I-N, Cribier.
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`24· · · ·Q.· C-R-I-B-I-E-R?
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`Page 011 of 199
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`·1· · · ·A.· Correct.
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`·2· · · · · · · · ·So it would change in that this
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`·3· ·procedure is in medical terms a fairly new
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`·4· ·procedure, and at the time that he did the
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`·5· ·first TAVR procedure, he was the only person
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`·6· ·that had done it and it wasn't a commonly used
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`·7· ·procedure.· Therefore, I am not sure people
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`·8· ·would be using the term.· It was something
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`·9· ·that he did first in the early 2000's.
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`10· · · ·Q.· Do you know if the acronym TAVR was in
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`11· ·common use by 2004?
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`12· · · · · · · · ·MR. EGAN:· Objection to form.
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`13· · · · · · · · ·THE WITNESS:· It depends what
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`14· ·you mean by "common" really.· I don't think I
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`15· ·know whether that particular acronym was being
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`16· ·used commonly.· It probably was used, but, I
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`17· ·mean, it depends what you mean by commonly,
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`18· ·because in 2004 these procedures are very new
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`19· ·and people are interested in them, such as
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`20· ·myself, may well have come across it.· But it
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`21· ·wouldn't necessarily be something that was in
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`22· ·the wider domain.
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`23· ·BY MR. COHN:
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`24· · · ·Q.· So just make sure I understand what
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`Page 012 of 199
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`·1· ·you are saying.· In June 2004, TAVR was a
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`·2· ·fairly new procedure; is that right?
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`·3· · · ·A.· Yes.
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`·4· · · ·Q.· And by that time, only one person in
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`·5· ·the whole world had performed TAVR procedures
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`·6· ·in human beings, is that right, and that is
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`·7· ·Dr. Cribier?
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`·8· · · ·A.· Yes, Dr. Cribier is the main one. I
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`·9· ·think by 2004 there may have been another
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`10· ·person in the United States who had attempted
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`11· ·them.· But again, it's difficult to answer
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`12· ·your question, what detail you go into.
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`13· · · · · · · · ·The way Alain Cribier did the
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`14· ·first ones was a very different route.· He
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`15· ·went up through the veins, across the septum.
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`16· ·He went a route that we sometimes refer to as
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`17· ·antegrade.
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`18· · · · · · · · ·What I described to you earlier
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`19· ·is, what's done today is almost always done
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`20· ·retrograde, going against the flow of blood,
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`21· ·coming up the aorta and into the valve.· So
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`22· ·there are things that have changed.· And you
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`23· ·can refer to them, and people might have, as
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`24· ·TAVR, going back that far to 2004, but a lot
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`Page 013 of 199
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`·1· ·about the procedure, the devices has changed.
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`·2· · · ·Q.· In 2004, I think you said that Alain
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`·3· ·Cribier had performed TAVR procedures and
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`·4· ·possibly another person in the US?
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`·5· · · ·A.· Yes.
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`·6· · · ·Q.· Who was that other person?
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`·7· · · ·A.· I can't remember, but I think there
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`·8· ·was someone else by the US.
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`·9· · · · · · · · ·And there are other valve
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`10· ·implantations done, pulmonary ones, by a
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`11· ·gentleman called Bonhoeffer, which are, if you
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`12· ·like -- if you take the "A" out of
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`13· ·transluminal valve implantation, it was done
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`14· ·by others, including Bonhoeffer.
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`15· · · · · · · · ·So it's all around, the interest
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`16· ·in putting heart valves in by percutaneous
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`17· ·transcatheter techniques really came to life
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`18· ·in the early 2000's and different people
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`19· ·working on pulmonary valves, from aortic
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`20· ·valves, and Alain Cribier was the first to
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`21· ·perform an aortic valve implantation, but he
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`22· ·did it by a different technique than the one
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`23· ·that was commonly used.
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`24· · · ·Q.· Now, if we expand our discussion
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`Page 014 of 199
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`·1· ·beyond just the aorta to talk about
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`·2· ·transcatheter valve replacement --
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`·3· · · ·A.· Yes.
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`·4· · · ·Q.· -- any valve in the heart, would you
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`·5· ·still have characterized that as a fairly new
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`·6· ·procedure by June of 2004?
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`·7· · · · · · · · ·MR. EGAN:· Objection to form.
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`·8· · · · · · · · ·THE WITNESS:· Yes.· It was a
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`·9· ·fairly new -- as I say, there were other
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`10· ·groups, including most notably Bonhoeffer's
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`11· ·group.· By 2004 I think he was in London.
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`12· ·He's a French -- he was a French doctor.· And
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`13· ·he was putting in pulmonary valves using a
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`14· ·different device which he had been involved in
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`15· ·developing.
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`16· ·BY MR. COHN:
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`17· · · ·Q.· By June 2004, had any regulatory body
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`18· ·approved for the commercial sale a
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`19· ·transcatheter replacement valve for any valve
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`20· ·in the heart?
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`21· · · ·A.· I don't believe so.
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`22· · · ·Q.· Has there been any approval by a
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`23· ·regulatory body for the commercial sale of a
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`24· ·transcatheter pulmonic replacement valve?
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`Page 015 of 199
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`·1· · · · · · · · ·MR. EGAN:· Objection to the
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`·2· ·form.
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`·3· · · · · · · · ·THE WITNESS:· Today?
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`·4· ·BY MR. COHN:
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`·5· · · ·Q.· Today?
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`·6· · · ·A.· Yes.
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`·7· · · ·Q.· What approval is that, what valve is
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`·8· ·that for the pulmonary?
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`·9· · · ·A.· The Melody valve is the valve that was
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`10· ·subsequently commercialized, which is related
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`11· ·to the original work that Bonhoeffer did, and
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`12· ·I think it is now, today, marketed by
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`13· ·Medtronic.
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`14· · · ·Q.· Are any of Edwards' transcatheter
`
`15· ·valve products approved by any regulatory body
`
`16· ·to be used in the pulmonic valve?
`
`17· · · · · · · · ·MR. EGAN:· Objection to form and
`
`18· ·relevance.
`
`19· · · · · · · · ·THE WITNESS:· The answer to
`
`20· ·that, there are so many different countries
`
`21· ·and regulatory authorities, I just don't know
`
`22· ·the answer.
`
`23· ·BY MR. COHN:
`
`24· · · ·Q.· Are you aware of any that have
`
`Page 016 of 199
`
`
`
`·1· ·approved any Edwards' valve for the pulmonic
`
`·2· ·valve?
`
`·3· · · · · · · · ·MR. EGAN:· Objection.
`
`·4· ·Relevance, form.
`
`·5· · · · · · · · ·THE WITNESS:· As I just said,
`
`·6· ·I'm not.· But I don't know that, I don't know
`
`·7· ·that there are not.
`
`·8· ·BY MR. COHN:
`
`·9· · · ·Q.· Now, you talked about Dr. Cribier had
`
`10· ·performed an antegrade approach with his valve
`
`11· ·replacements in the aorta by June 2004; is
`
`12· ·that right?
`
`13· · · ·A.· Correct.
`
`14· · · ·Q.· What is the difference between an
`
`15· ·antegrade approach and a retrograde approach?
`
`16· · · ·A.· Well, in brief, to go antegrade,
`
`17· ·you're going with the flow of blood and,
`
`18· ·therefore, you go typically up a vein in the
`
`19· ·leg, and you go up to the heart the direction
`
`20· ·the blood returns to the heart.· And then you
`
`21· ·have to cross over from the right side of the
`
`22· ·heart to the left side of the heart, and you
`
`23· ·make a hole with a needle and then stretch it
`
`24· ·up with a balloon to do that.· Then you go
`
`Page 017 of 199
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`
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`·1· ·into the left side of the heart, and you go
`
`·2· ·into the aortic valve from the direction of
`
`·3· ·the ventricle towards the aorta.
`
`·4· · · · · · · · ·So it is a more difficult, more
`
`·5· ·complex procedure in some respects because you
`
`·6· ·are traveling a lot longer distance, and you
`
`·7· ·are putting the valve into the same position,
`
`·8· ·into the subcoronary aortic position, but
`
`·9· ·you're doing it via this so-called antegrade
`
`10· ·route.
`
`11· · · · · · · · ·And that is what Alain Cribier
`
`12· ·did for the first half dozen or so procedures
`
`13· ·that he performed.
`
`14· · · ·Q.· And the first half dozen or so
`
`15· ·procedures that Dr. Cribier performed were all
`
`16· ·before June 2004?
`
`17· · · · · · · · ·MR. EGAN:· Objection to form.
`
`18· · · · · · · · ·THE WITNESS:· I don't know the
`
`19· ·exact number.· There were that sort of number
`
`20· ·of procedures that he and his group performed
`
`21· ·before 2004.
`
`22· ·BY MR. COHN:
`
`23· · · ·Q.· As far as you are aware, had anyone in
`
`24· ·the world performed a retrograde approach for
`
`Page 018 of 199
`
`
`
`·1· ·a transcatheter aortic valve replacement
`
`·2· ·before June 2004?
`
`·3· · · ·A.· I don't know the answer to that, I'm
`
`·4· ·afraid.
`
`·5· · · ·Q.· You are not aware of any such
`
`·6· ·procedures sitting here today?
`
`·7· · · ·A.· Well, I'm talking about in my
`
`·8· ·answer -- sorry, I should have prefaced it --
`
`·9· ·it is involved in patients, to treat patients.
`
`10· · · · · · · · ·In animals, yes, they had.
`
`11· ·Experimental work and animal work was
`
`12· ·definitely being done, and I'm aware of it, in
`
`13· ·that case right back to Andersen's work,
`
`14· ·Henning Rudd Andersen.
`
`15· · · · · · · · ·But I'm not, as I sit here
`
`16· ·today, aware as to whether anyone had
`
`17· ·performed a retrograde procedure before
`
`18· ·June 2004.
`
`19· · · ·Q.· Before June 2004, it is your testimony
`
`20· ·that retrograde TAVR procedures had been
`
`21· ·performed in animals?
`
`22· · · ·A.· Well, I don't know whether you call
`
`23· ·them TAVR procedures because they are
`
`24· ·experimental.
`
`Page 019 of 199
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`
`
`·1· · · · · · · · ·I mean, again, the terminology
`
`·2· ·I'm not sure was used back then.· But
`
`·3· ·experimental work, put valves in going
`
`·4· ·retrogradely in experimental procedures, you
`
`·5· ·often don't start down the leg of the animal.
`
`·6· ·You may go into the aorta.· But they are being
`
`·7· ·put in retrogradely, coming up the aorta and
`
`·8· ·around into the aortic position, against the
`
`·9· ·flow of blood.· That had been done
`
`10· ·experimentally, yes.
`
`11· · · ·Q.· And when you said that these
`
`12· ·procedures were done not through the leg of
`
`13· ·the animal, how was the device implanted into
`
`14· ·the aorta and then into the heart valve?
`
`15· · · ·A.· Sometimes for ease it would be put
`
`16· ·directly into the aorta but down below the
`
`17· ·diaphragm.· So to get in, because the devices
`
`18· ·were a certain size, animals have quite small
`
`19· ·blood vessels in the leg, so it would go into
`
`20· ·the aorta and then continue up the aorta.
`
`21· · · ·Q.· In your entire career, you have never
`
`22· ·performed a TAVR procedure on a human patient;
`
`23· ·is that correct?
`
`24· · · ·A.· Correct.
`
`Page 020 of 199
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`
`
`·1· · · ·Q.· And you have never performed any
`
`·2· ·transcatheter or transluminal valve
`
`·3· ·replacement procedure on a human patient?
`
`·4· · · ·A.· Replacement procedure, no, I've never
`
`·5· ·performed.
`
`·6· · · ·Q.· And you have never performed a valve
`
`·7· ·replacement procedure on an animal; is that
`
`·8· ·correct?
`
`·9· · · ·A.· Correct.
`
`10· · · ·Q.· And you have never deployed a TAVR
`
`11· ·device in a bench test or in any setting; is
`
`12· ·that right?
`
`13· · · ·A.· I have deployed TAVR devices in bench
`
`14· ·tests, yes.· I've examined devices and
`
`15· ·equipment and I have deployed some.· But I
`
`16· ·have never treated a patient and I have never
`
`17· ·implanted one in an animal.· But I have
`
`18· ·inspected and looked at devices, including
`
`19· ·deploying some.
`
`20· · · · · · · · ·By "deploy," I mean on the
`
`21· ·bench.· I mean not into an animal or human
`
`22· ·tissue.
`
`23· · · ·Q.· When you say "on the bench" -- well,
`
`24· ·let's back up.
`
`Page 021 of 199
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`
`
`·1· · · · · · · · ·In the devices that you have
`
`·2· ·deployed, TAVR devices on the bench, were they
`
`·3· ·being deployed in air or were they in some
`
`·4· ·sort of a fixture or a model or something like
`
`·5· ·that?
`
`·6· · · · · · · · ·MR. EGAN:· Objection.· Compound.
`
`·7· · · · · · · · ·THE WITNESS:· Water bath, I
`
`·8· ·think.· So under water, a water bath.· But I'm
`
`·9· ·not sure what you mean by a fixture.· I didn't
`
`10· ·quite understand what you meant in the
`
`11· ·question by a fixture in a tank, which would
`
`12· ·be...
`
`13· ·BY MR. COHN:
`
`14· · · ·Q.· How many times have you deployed a
`
`15· ·transcatheter valve replacement device?
`
`16· · · ·A.· Very few.· I mean a couple.
`
`17· · · ·Q.· Twice?
`
`18· · · ·A.· Two, three, four.
`
`19· · · ·Q.· Less than five?
`
`20· · · ·A.· I think that is fair.
`
`21· · · ·Q.· And the times that you deployed a
`
`22· ·transcatheter valve device, it was always in a
`
`23· ·water bath?
`
`24· · · ·A.· No, it wasn't always in a water bath,
`
`Page 022 of 199
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`
`
`·1· ·but the majority have been in a water bath to
`
`·2· ·keep -- look at the valve and to do it with
`
`·3· ·something approaching body temperature.
`
`·4· · · ·Q.· And these deployments of a
`
`·5· ·transcatheter valve device that you did on the
`
`·6· ·bench -- is that how you characterize it, on
`
`·7· ·the bench?
`
`·8· · · ·A.· Yes, broadly.· I mean, that's an
`
`·9· ·expression, meaning outside a patient.
`
`10· ·Experimental, just inspecting it.· So on a
`
`11· ·bench, yes, that's fair.
`
`12· · · ·Q.· The transcatheter valve devices that
`
`13· ·you deployed on the bench, was that in
`
`14· ·conjunction with your work as an expert in a
`
`15· ·litigation?
`
`16· · · ·A.· Some of it was and some of it wasn't.
`
`17· ·Just a medical meeting.· So both.
`
`18· · · ·Q.· The deployment of a transcatheter
`
`19· ·valve device that you did as part of a medical
`
`20· ·meeting, was that in 2013?
`
`21· · · ·A.· I certainly did.· That is the training
`
`22· ·course, the Edwards training course that I
`
`23· ·went to in New York.· And, yes, certainly
`
`24· ·there was one I deployed during that meeting.
`
`Page 023 of 199
`
`
`
`·1· · · ·Q.· Had you deployed a TAVR device on the
`
`·2· ·bench prior to 2013 other than in your
`
`·3· ·capacity as a litigation expert?
`
`·4· · · ·A.· Yes, at a medical meeting.
`
`·5· · · ·Q.· When was that medical meeting?
`
`·6· · · ·A.· I honestly don't remember.
`
`·7· · · ·Q.· Was it after 2007?
`
`·8· · · ·A.· I would guess, sitting here, it was
`
`·9· ·after 2010, I would guess.
`
`10· · · ·Q.· Do you agree it was certainly after
`
`11· ·2007?
`
`12· · · ·A.· Well, I have agreed.· I think I said
`
`13· ·after 2010, so that is by definition after
`
`14· ·2007.
`
`15· · · ·Q.· What was the transcatheter valve
`
`16· ·device that you deployed at a medical meeting
`
`17· ·some time after 2010?
`
`18· · · ·A.· CoreValve device, the Medtronic
`
`19· ·CoreValve device is one I remember.
`
`20· · · ·Q.· At the time that you did that
`
`21· ·deployment, you had been retained as an expert
`
`22· ·in litigation for Edwards around the
`
`23· ·CoreValve; right?
`
`24· · · · · · · · ·MR. EGAN:· Objection.
`
`Page 024 of 199
`
`
`
`·1· ·Foundation.
`
`·2· · · · · · · · ·THE WITNESS:· Yes.· I'm trying
`
`·3· ·to think how long, how far back that was, but
`
`·4· ·that was around 2007, yes.
`
`·5· ·BY MR. COHN:
`
`·6· · · ·Q.· Was that the first time, that
`
`·7· ·CoreValve deployment that you just mentioned
`
`·8· ·at the medical meeting, that you had deployed
`
`·9· ·a TAVR device in your career?
`
`10· · · ·A.· I can't remember whether I deployed an
`
`11· ·Edwards one.· Just as I sit here can't
`
`12· ·remember, so I can't answer that.· I don't
`
`13· ·know.
`
`14· · · ·Q.· When was the first time that you
`
`15· ·recall deploying a transcatheter valve device
`
`16· ·in your entire life?
`
`17· · · ·A.· Well, as I say, I don't think the
`
`18· ·CoreValve one was before 2010, and I think I
`
`19· ·may well have deployed an Edwards one,
`
`20· ·bench-top deployment before then, but I
`
`21· ·honestly can't remember the year.
`
`22· · · ·Q.· It would have been after 2007 that you
`
`23· ·did that; right?
`
`24· · · ·A.· I can't remember the year.
`
`Page 025 of 199
`
`
`
`·1· · · ·Q.· Could it have been before 2007?
`
`·2· · · ·A.· I can't remember the year.· I can't
`
`·3· ·remember, so I can't give you a date.
`
`·4· · · ·Q.· You have never deployed a
`
`·5· ·transcatheter valve device that had had a seal
`
`·6· ·around the outside of the device; is that
`
`·7· ·right?
`
`·8· · · · · · · · ·MR. EGAN:· Objection.
`
`·9· ·Foundation.
`
`10· · · · · · · · ·THE WITNESS:· Depending on what
`
`11· ·you mean by a seal, no.· I mean, obviously,
`
`12· ·the intent with the device is it didn't have
`
`13· ·fabric around the outside.· It was still a
`
`14· ·seal.· But I have not deployed one at all that
`
`15· ·has a fabric around the outside.
`
`16· · · · · · · · ·I've done a few stitches
`
`17· ·traveling around stents to actually secure
`
`18· ·what's inside the stent.
`
`19· ·BY MR. COHN:
`
`20· · · ·Q.· Now, in your report you mention a
`
`21· ·hands-on training in 2013 regarding TAVR
`
`22· ·devices?
`
`23· · · ·A.· Yes.
`
`24· · · ·Q.· And that 2013 training was provided by
`
`Page 026 of 199
`
`
`
`·1· ·Edwards; is that right?
`
`·2· · · ·A.· Yes.· It was a formal Edwards training
`
`·3· ·session for physicians, which I attended, I
`
`·4· ·requested to go and attend it.· And I went
`
`·5· ·along to listen and take part in the training
`
`·6· ·session.· It wasn't arranged for me.· It was a
`
`·7· ·routine session to train people who were going
`
`·8· ·to potentially go ahead and implant Edwards'
`
`·9· ·devices in the United States and outside, from
`
`10· ·memory.
`
`11· · · ·Q.· It was an Edwards training session?
`
`12· · · ·A.· Well, I don't know.· It was certainly
`
`13· ·organized on behalf of Edwards, but it was at
`
`14· ·a hospital with physicians.· So I'm not sure
`
`15· ·whether, but it was absolutely on behalf of
`
`16· ·Edwards, and it included a lot of physicians
`
`17· ·who were well known in the field of TAVR.
`
`18· · · ·Q.· Who was one of the physicians who was
`
`19· ·well known in the field of TAVR who was at the
`
`20· ·training session you attended in 2013?
`
`21· · · ·A.· Marty Leon.
`
`22· · · ·Q.· Anyone else?
`
`23· · · ·A.· There were lots, but I can't remember,
`
`24· ·as I sit here.
`
`Page 027 of 199
`
`
`
`·1· · · ·Q.· Do you know if Marty Leon regularly
`
`·2· ·attends and teaches at Edwards training
`
`·3· ·sessions?
`
`·4· · · ·A.· I don't know if he does now.· I mean I
`
`·5· ·think -- I don't know the answer to that. I
`
`·6· ·mean you would have to ask him.· I don't know.
`
`·7· · · ·Q.· And at the training session, did you
`
`·8· ·personally deploy a TAVR device on the bench
`
`·9· ·or did you watch it be done?
`
`10· · · ·A.· Did I purposely arrange the thing? I
`
`11· ·honestly don't remember.· I don't remember.
`
`12· ·There were lots of -- it was a question of
`
`13· ·different people looking and holding things.
`
`14· ·I don't remember.
`
`15· · · ·Q.· Do you remember which of the Edwards'
`
`16· ·TAVR devices you had hands-on training with at
`
`17· ·the 2013 hands-on training?
`
`18· · · ·A.· I don't, as I sit here now, I'm
`
`19· ·afraid.
`
`20· · · ·Q.· Was the Sapien 3 part of the hands-on
`
`21· ·training?
`
`22· · · ·A.· No, it wasn't.· The Sapien 3 was not
`
`23· ·part of it at all.
`
`24· · · ·Q.· So it was either the XT or the
`
`Page 028 of 199
`
`
`
`·1· ·original Sapien?
`
`·2· · · ·A.· Correct.
`
`·3· · · ·Q.· And you can't remember which one?
`
`·4· · · ·A.· I can't.
`
`·5· · · ·Q.· And when you say "hands-on training,"
`
`·6· ·did you actually put your hands on the
`
`·7· ·product?
`
`·8· · · ·A.· Yes.· There were products there to
`
`·9· ·look at and examine and, yes, absolutely,
`
`10· ·hands on, touching the product.
`
`11· · · ·Q.· You touched the valve?
`
`12· · · ·A.· Yes.· I can't remember if they were
`
`13· ·ones that were real valves in preservative --
`
`14· ·I think some of them were -- and if there were
`
`15· ·gloves.· But there were other ones, main ones,
`
`16· ·if you like, sort of a mock-up is the real
`
`17· ·stent and the real fabric, Dacron, but the
`
`18· ·valve is replaced by non-animal tissue so that
`
`19· ·you can look at them, and there were ones like
`
`20· ·that as well, I think.
`
`21· · · ·Q.· Just so we are clear, I used the
`
`22· ·word "valve."· What I meant is the whole valve
`
`23· ·device.· You picked up the whole Sapien or
`
`24· ·Sapien XT valve device and looked at it?
`
`Page 029 of 199
`
`
`
`·1· · · ·A.· Yes.
`
`·2· · · ·Q.· Did you do anything with it other than
`
`·3· ·look at it?
`
`·4· · · ·A.· Well, handle it, feel it, look at it.
`
`·5· ·But I was already familiar with them, so that
`
`·6· ·wasn't -- I mean I had already handled and
`
`·7· ·touched and examined many before going to that
`
`·8· ·meeting.
`
`·9· · · ·Q.· In the course of your work as a
`
`10· ·litigation expert?
`
`11· · · ·A.· Mainly in the course of litigation
`
`12· ·expert acting for Edwards, but also at medical
`
`13· ·meetings.
`
`14· · · ·Q.· Can you identify the medical meetings
`
`15· ·where you actually put your hands on a
`
`16· ·transcatheter valve product?
`
`17· · · ·A.· I can't as I sit here.· I mean
`
`18· ·meetings, a TCT meeting in the United States,
`
`19· ·it is one of the big interventional cardiology
`
`20· ·meetings.
`
`21· · · ·Q.· And those are attended by hundreds of
`
`22· ·cardiologists?
`
`23· · · ·A.· Thousands.· I mean it started as
`
`24· ·hundreds.· I went in the very early days when
`
`Page 030 of 199
`
`
`
`·1· ·it was a few hundreds, but it's grown and
`
`·2· ·grown over the years, and I think it is now up
`
`·3· ·above 10,000 delegates.· They are not all
`
`·4· ·interventional cardiologists, but it is now a
`
`·5· ·very large meeting, annual meeting.
`
`·6· · · ·Q.· How many other people were being
`
`·7· ·trained with you at the 2013 Edwards training
`
`·8· ·session that you attended?
`
`·9· · · · · · · · ·MR. EGAN:· Objection.
`
`10· ·Relevance.
`
`11· · · · · · · · ·THE WITNESS:· On the order of a
`
`12· ·dozen, that sort of order.· It was a small
`
`13· ·coach that picked us up from the hotel and
`
`14· ·took us to the hospital.· So it was of the
`
`15· ·order of a dozen.· But I can't be more precise
`
`16· ·than that.
`
`17· ·BY MR. COHN:
`
`18· · · ·Q.· And that was the first time you
`
`19· ·received training in the use of a TAVR device?
`
`20· · · · · · · · ·MR. EGAN:· Objection to form.
`
`21· · · · · · · · ·THE WITNESS:· No.· This was the
`
`22· ·first time I attended one of these formalized
`
`23· ·training sessions, but, obviously, I had been
`
`24· ·to lots of medical meetings, seen live
`
`Page 031 of 199
`
`
`
`·1· ·procedures, been to the stands of companies
`
`·2· ·including Edwards, and read scientific
`
`·3· ·articles, medical articles.· So learning about
`
`·4· ·these devices is an ongoing process which
`
`·5· ·includes being up to date with literature,
`
`·6· ·going to medical meetings, watching live
`
`·7· ·demonstrations.
`
`·8· · · · · · · · ·And then I wanted to go and I
`
`·9· ·requested to go to a formal meeting to
`
`10· ·actually hear what was being told to people
`
`11· ·who were trai
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