`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF CALIFORNIA
`HONORABLE MICHAEL M. ANELLO, DISTRICT JUDGE
`MEDTRONIC SOFAMOR DANEK, USA, .
`ET AL., .CASE NO. 08-CV-1512-MMA
`.
`PLAINTIFF,
`.
`.
`V.
`. AUGUST 31, 2011
`.
`NUVASIVE, INC.,
`. WEDNESDAY, 1:30 P.M.
`.
`DEFENDANT.
`. TRIAL - DAY TWO
`. . . . . . . . . . . . . . . . . ..
`
`REPORTER'S TRANSCRIPT OF PROCEEDINGS
`
`APPEARANCES:
`FOR THE PLAINTIFF:
`
`FOR THE DEFENDANTS:
`
`LUKE L. DAUCHOT, ESQ.
`NIMALKA WICKRAMASEKERA, ESQ.
`SHARRE LOTFOLLAHI, ESQ.
`ALEXANDER F. MACKINNON, ESQ.
`MICHAEL DOBSZEWICZ, ESQ.
`KIRKLAND & ELLIS, LLP
`JEFF SCHWARTZ, ESQ.
`DEWEY & LEBOEUF
`
`FRANK SCHERKENBACH, ESQ.
`JOHN M. FARRELL, ESQ.
`TODD G. MILLER, ESQ.
`JONATHAN J. LAMBERSON, ESQ.
`NEIL WARREN, ESQ.
`KEELEY I. VEGA, ESQ.
`
`COURT REPORTER:
`
`JULIET Y. EICHENLAUB, CSR
`USDC CLERK'S OFFICE
`880 FRONT STREET, ROOM 4290
`SAN DIEGO, CALIFORNIA 92101
`JULIET_EICHENLAUB@CASD.USCOURTS.GOV
`REPORTED BY STENOTYPE, TRANSCRIBED BY COMPUTER
`
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`Page 1
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`WARSAW2064
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`Case IPR2013-00206
`
`
`
`08-CV-1512-MMA
`
`INDEX - 08-CV-1512
`MEDTRONIC V. NUVASIVE, 8/31/11
`
`WITNESSES:
`
` DIRECT CROSS REDIRECT RECROSS
`
`DAVID ALAN SHARP
`PATRICK MILES
`
` 312
` 401
`
` 336
` 435
`
`361
`
`VIDEOTAPE DEPOSITION OF DR. SMITH
`VIDEOTAPE DEPOSITION OF DR. FOLEY
`READING OF DEPOSITION TESTIMONY OF DR. FOLEY
`
`PAGE 365
` PAGE 382
`PAGE 391
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`Page 2
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`08-CV-1512-MMA
`
`ANSWER: YES.
`QUESTION: WHAT DID YOU THINK?
`ANSWER: I THOUGHT IT WAS AN INTERESTING START. THE
`NOTION OF TRYING TO NOT ONLY STIMULATE A NERVE BUT MONITOR
`THE LOCATION OF THAT NERVE OR THE PROXIMITY OF THAT NERVE
`WAS ONE OF THE GOALS OF NUVASIVE'S WORK, AS LEAST AS FAR
`AS I WAS INVOLVED IN IT. AND THIS WAS -- THIS WAS VERY
`EARLY WORK, BUT IT WAS HEADED IN THAT DIRECTION."
`MS. WICKRAMASEKERA: AND THAT'S THE END OF THE
`TRANSCRIPT, YOUR HONOR.
`THE COURT: ALL RIGHT. THANK YOU, DR. FOLEY. YOU
`DID A VERY GOOD JOB.
`THE WITNESS: THANK YOU.
`MS. WICKRAMASEKERA: I'D JUST LIKE TO ADD THAT DURING
`THESE VIDEO CLIPS, WE SAW THE FOLLOWING EXHIBITS: PX305,
`PX2490, PX2491, PX2493, AND PX2492.
`THE COURT: ALL RIGHT.
`MS. WICKRAMASEKERA: THANK YOU.
`THE COURT: NEXT WITNESS.
`MR. DAUCHOT: YOUR HONOR, FOR OUR NEXT WITNESS, WE
`CALL MR. PATRICK MILES.
`PATRICK MILES, PLAINTIFF'S WITNESS, TESTIFIED AS FOLLWS:
`THE CLERK: PLEASE RAISE YOUR RIGHT HAND. DO YOU
`SOLEMNLY SWEAR THAT THE TESTIMONY YOU SHALL GIVE IN THE CAUSE
`NOW BEFORE THE COURT IS THE TRUTH, THE WHOLE TRUTH, AND NOTHING
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`08-CV-1512-MMA
`
`BUT THE TRUTH, SO HELP YOU GOD?
`THE WITNESS: I DO.
`THE CLERK: PLEASE STATE YOUR FULL NAME FOR THE
`RECORD AND SPELL IT PLEASE.
`THE WITNESS: PATRICK MILES. LAST NAME, M-I-L-E-S.
`FIRST NAME, P-A-T-R-I-C-K.
`THE COURT: THANKS, MR. MILES. GO AHEAD AND HAVE A
`SEAT. MR. DAUCHOT?
`
`DIRECT EXAMINATION
`
`BY MR. DAUCHOT:
`Q.
`THANK YOU, YOUR HONOR.
`MR. MILES, GOOD AFTERNOON.
`GOOD AFTERNOON.
`THIS IS THE FIRST TIME WE MET?
`FIRST TIME YOU AND I MET?
`YES.
`I BELIEVE SO.
`YOU'VE BEEN DEPOSED IN THIS CASE BEFORE, THOUGH?
`I HAVE.
`I THINK MY COLLEAGUE, MS. WICKRAMASEKERA, DID THAT.
`DO YOU REMEMBER THAT?
`I DO.
`YOU BEGAN WORKING FOR NUVASIVE IN JANUARY 2001; AM I
`
`A.
`Q.
`A.
`Q.
`A.
`Q.
`A.
`Q.
`
`A.
`Q.
`RIGHT?
`A.
`
`YES.
`
`401
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`08-CV-1512-MMA
`
`AND YOU -- THAT'S WHEN MR. VALENTINE ALSO JOINED THE
`Q.
`COMPANY; CORRECT?
`A.
`IT IS.
`Q.
`AND YOU LEFT MEDTRONIC SOFAMOR DANEK IN APRIL OF
`2000; IS THAT ABOUT RIGHT?
`A.
`I BELIEVE SO; YEAH, LEFT MEDTRONIC.
`Q.
`AND WHEN YOU LEFT MEDTRONIC SOFAMOR DANEK, YOUR
`PRINCIPAL AREA OF WORK WAS WHAT WE CALL MINIMALLY INVASIVE
`SPINE SURGERY DEVICES; AM I RIGHT?
`A.
`YES; IT WAS THAT AND CERVICAL SPINE SURGERY.
`Q.
`AND WHEN YOU WORKED ON MINIMALLY INVASIVE SPINE
`SURGERY DEVICES FOR SOFAMOR DANEK, YOU DID SO WITH DR. FOLEY;
`AM I CORRECT?
`A.
`YES, I DID.
`Q.
`AND YOU ALSO WORKED WITH MR. MELKENT; AM I RIGHT?
`A.
`NOT DIRECTLY.
`Q.
`INDIRECTLY?
`A.
`INDIRECTLY, YES.
`Q.
`INDIRECTLY. ALL RIGHT.
`AND YOU ALSO WORKED WITH MR. BOYD?
`NOT COMMONLY.
`A.
`UNCOMMONLY?
`Q.
`IF THAT'S THE WAY YOU'D LIKE TO CHARACTERIZE IT. I
`A.
`DIDN'T SEE HIM VERY OFTEN.
`Q.
`OKAY.
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`Page 5
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`08-CV-1512-MMA
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`BUT YOU DID WORK WITH HIM FROM TIME TO TIME?
`HE WAS WITH THE SAME COMPANY, YES. I DON'T RECALL,
`A.
`FROM TIME TO TIME.
`Q.
`AND MR. BOYD IS NOW A CONSULTANT TO NUVASIVE?
`A.
`YES.
`Q.
`ALL RIGHT.
`NOW, NUVASIVE COMMERCIALLY LAUNCHED XLIF IN OCTOBER
`2003; AM I RIGHT?
`A.
`YES.
`Q.
`AND I TAKE IT THAT YOU WERE INVOLVED IN THAT RELEASE,
`THAT PUBLIC LAUNCH?
`A.
`UH-HUH, YES, I WAS.
`Q.
`AND I ASSUME YOU DID THAT WHEN YOU FELT THAT THE
`ENTIRE XLIF SYSTEM WAS READY TO LAUNCH FOR THE PUBLIC; FAIR
`STATEMENT?
`A.
`WE LAUNCHED IT WHEN WE FELT IT WAS A SAFE AND
`REPRODUCIBLE PROCEDURE.
`Q.
`YOU LAUNCHED IT WHEN YOU THOUGHT IT WAS SAFE AND WHEN
`YOU THOUGHT IT WAS REPRODUCIBLE, RIGHT?
`A.
`YES.
`Q.
`NOW, YOUR POSITION IS THAT NEUROVISION WAS KEY TO
`THAT; AM I RIGHT?
`A.
`YES.
`Q.
`ALL RIGHT.
`NOW, DO YOU RECALL -- WELL, LET'S TAKE A STEP BACK.
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`08-CV-1512-MMA
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`A.
`Q.
`
`CAN YOU SEE THAT OKAY?
`I CAN.
`OKAY.
`SO YOU LAUNCH XLIF, AND XLIF STANDS FOR EXTREME
`LATERAL INTERBODY FUSION?
`A.
`THAT'S CORRECT.
`Q.
`IN OCTOBER OF 2003; CORRECT?
`A.
`YES, SIR.
`Q.
`AND YOU LAUNCHED IT THEN BECAUSE AT THAT POINT IN
`TIME THE SYSTEM, XLIF, WAS, AS YOU PUT IT, SAFE TO DO AND
`REPRODUCIBLE, RIGHT?
`A.
`YES.
`Q.
`NOW, THAT'S OCTOBER 2003.
`LET'S GO BACK IN TIME; OKAY. AND LET'S GET US TO
`NOVEMBER OF 2001. I ASSUME THAT SINCE YOU HADN'T LAUNCHED XLIF
`YET THAT AT THIS TIME IT WASN'T SAFE AND REPRODUCIBLE;
`CORRECT?
`IT WAS -- IT HADN'T COME UP. I GUESS I DON'T
`A.
`UNDERSTAND YOUR QUESTION.
`Q.
`MY QUESTION IS: YOU LAUNCHED IT IN OCTOBER 2003
`BECAUSE XLIF WAS, I THINK YOU SAID, READY; IN THAT SENSE, YOU
`MEANT SAFE AND REPRODUCIBLE?
`A.
`YES. WE WENT THROUGH THE ENTIRE DESIGN PROCESS, AND
`WE HAD NEVER CONTEMPLATE IT IN NOVEMBER 2001.
`Q.
`YOU NEVER CONTEMPLATE IT IN 2001?
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`404
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`Page 7
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`08-CV-1512-MMA
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`NOT WHAT WAS RELEASED IN 2003.
`A.
`NOW, WHAT I'D LIKE YOU TO TURN TO IS PX2541. IT'S A
`Q.
`RELEASE, A PRESS RELEASE, FROM NUVASIVE, DATED NOVEMBER 27TH,
`2001. DAVE, CAN YOU PUT THAT UP FOR US? CAN YOU PUT THAT UP
`FOR US?
`
`ALL RIGHT. AND CAN YOU BLOW UP THE BOTTOM, THE
`SECOND PARAGRAPH FROM THE BOTTOM.
`THIS IS A DOCUMENT DATED NOVEMBER 2001; CORRECT,
`MR. MILES?
`A.
`IT APPEARS AS SUCH.
`Q.
`IT'S A PRESS RELEASE FROM NUVASIVE; AM I CORRECT,
`MR. MILES?
`A.
`IT APPEARS SO, YES.
`Q.
`WE ARE NOW AT NOVEMBER 27, 2001. "THE MINIMALLY
`INVASIVE XLIF, STANDING FOR EXTREME LATERAL INTERBODY FUSION
`APPROACH TO THE SPINE DEVELOPED BY NUVASIVE IS MADE POSSIBLE
`THROUGH ACTIVE NERVE MONITORING OFFERED BY THE NEUROVISION
`SYSTEM."
`
`DO YOU SEE THAT?
`YES, I DO.
`A.
`SO YOU IN FACT DID HAVE -- YOU WERE TELLING THE
`Q.
`PUBLIC IN NOVEMBER 2001 THAT YOU DID HAVE XLIF?
`A.
`UNDER THE AUSPICES OF XLIF 60; IT WAS A DIFFERENT
`PROCEDURE THAN WHAT WAS, THAN WHAT WAS LAUNCHED IN OCTOBER OF
`2003.
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`08-CV-1512-MMA
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`IT WAS A DIFFERENT XLIF?
`Q.
`THAT'S CORRECT.
`A.
`SO YOU HAD TWO XLIF PROCEDURES AT NUVASIVE?
`Q.
`THAT'S CORRECT.
`A.
`WAS IT XLIF, WHAT, ONE AND XLIF TWO?
`Q.
`NO. IT WAS XLIF 60 AND XLIF 90.
`A.
`IS THERE A DOCUMENT THAT SHOWS US THE XLIF 60 VERSUS
`Q.
`THE XLIF 90 THAT YOU KNOW OF?
`A.
`I'M SURE THERE IS. THERE'S BEEN A BOOK CHAPTER ON
`XLIF 60 AND A BOOK CHAPTER ON XLIF 90.
`Q.
`IT'S A FACT THAT IN 2001 THAT XLIF WAS NOT SAFE AND
`REPRODUCIBLE; CORRECT?
`A.
`IN 2001, XLIF WAS NOT SAFE AND REPRODUCIBLE.
`Q.
`ALL RIGHT. NOW IN NOVEMBER 2001 --
`A.
`LET ME ANSWER THE QUESTION. I WOULD SAY IT DEPENDS
`UPON WHO WAS DOING THE SURGERY.
`Q.
`I SEE.
`NOW, IN NOVEMBER OF 2001, YOU HAD NEUROMONITORING;
`HAD YOU NEUROVISION, RIGHT?
`A.
`THAT'S CORRECT.
`Q.
`AND IN NOVEMBER OF 2001, YOU HAD THE XLIF PROCEDURE
`SURGICAL APPROACH; AM I CORRECT?
`A.
`WE HAD XLIF 60.
`Q.
`XLIF 60.
`NOW, XLIF 60, WAS THAT THE SURGICAL PROCEDURE
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`08-CV-1512-MMA
`
`A.
`Q.
`
`DEVELOPED BY DR. PIMENTA?
`A.
`NO.
`Q.
`ALL RIGHT. WE'LL COME BACK TO THAT.
`BY OCTOBER OF 2003, YOU HAD TWO ADDITIONAL THINGS:
`YOU HAD MORE THAN NEUROVISION, AND YOU HAD MORE THAN THE XLIF
`PROCEDURE; AM I CORRECT?
`A.
`WE HAD MORE COMPONENTS TO THE PROCEDURE AND A
`COMPLETELY DIFFERENT PROCEDURE.
`Q.
`OKAY.
`SO IT WAS A COMPLETELY DIFFERENT PROCEDURE?
`THAT'S CORRECT.
`AND HOW WAS THE PROCEDURE DIFFERENT?
`THERE'S A RULE IN CROSS-EXAMINATION: YOU NEVER ASK A
`QUESTION TO WHICH YOU DON'T KNOW THE ANSWER, AND I DON'T KNOW
`THE ANSWER TO THAT QUESTION. BUT I'LL ASK IT ANYWAY.
`A.
`THERE ARE NUMEROUS DISTINCTIONS IN THE TWO DIFFERENT
`PROCEDURES.
`Q.
`WHAT'S XLIF 60?
`A.
`ONE IS -- XLIF 60 WOULD BE IF YOU'RE LAYING ON YOUR
`BELLY, AND YOU GO OFF OF THE MIDLINE 60 DEGREES, AND YOU
`APPROACH THE SPINE IN THAT MANNER. SO IT WOULD BE MORE OF A
`POSTERIOR-LATERAL APPROACH. THE XLIF 90 WOULD BE IF SOMEONE IS
`LAYING ON THEIR SIDE, AND WHAT YOU DO IS APPROACH IT FROM A
`DIRECT 90-DEGREE APPROACH. SO 90-DEGREE MIDLINE VERSUS
`60-DEGREE MIDLINE. THE REQUIREMENTS FOR THOSE SURGERIES ARE
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`COMPLETELY DIFFERENT.
`Q.
`ALL RIGHT.
`YOU'RE SAYING THIS WAS A PROCEDURE -- XLIF 60 WAS NOT
`DEVELOPED BY DR. PIMENTA?
`A.
`THAT'S CORRECT.
`Q.
`AND XLIF 90, WAS THAT DEVELOPED BY DR. PIMENTA?
`A.
`YES, IT WAS.
`Q.
`AS OF NOVEMBER 2001, YOU DID NOT HAVE XLIF 60
`DEVELOPED BY DR. PIMENTA; OR YOU HAD XLIF 60, BUT IT WAS NOT
`DEVELOPED BY DR. PIMENTA?
`A.
`THAT'S CORRECT.
`Q.
`NOW, CAN WE PUT UP, CHRIS, THE TEXTBOOK?
`LET ME JUST MAKE CLEAR SO WE ALL UNDERSTAND. XLIF
`60, NO DR. PIMENTA, RIGHT; AND XLIF 90, DR. PIMENTA; AM I
`RIGHT?
`A.
`Q.
`SIR?
`PX WHAT?
`A.
`44, THE TEXTBOOK?
`Q.
`YES.
`A.
`AND THAT IS -- OKAY. PX 44. WHAT I'D LIKE TO DO IS
`Q.
`TURN TO, AND FLIP IN A COUPLE PAGES TO THE ACKNOWLEDGEMENT.
`YOU SEE ACKNOWLEDGEMENTS. CAN YOU BLOW THAT UP FOR US, DAVID,
`PLEASE? WE ARE ON PAGE -- IT'S THE PREFACE -- ROMAN NUMERAL
`
`YES.
`NOW, I WANT TO -- DO YOU HAVE PX44 IN FRONT OF YOU,
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`08-CV-1512-MMA
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`XVI. YOU WITH ME?
`A.
`I BELIEVE SO.
`Q.
`ALL RIGHT.
`AND THEN AT THE TOP, THE FIRST LINE OF THE
`ACKNOWLEDGEMENTS, YOU STATE -- NOW, THIS IS A BOOK COPYRIGHTED
`BY NUVASIVE; AM I CORRECT?
`A.
`I BELIEVE SO, YES.
`Q.
`AND YOU HELPED PUT THE BOOK TOGETHER, RIGHT? THAT'S
`WHAT THE SECOND PARAGRAPH OF THE ACKNOWLEDGEMENT STATES.
`A.
`DID I HELP PUT IT TOGETHER?
`Q.
`YES.
`A.
`PHYSICALLY, I DIDN'T. I WAS, I'M PROUD OF THE BOOK;
`BUT TO SUGGEST THAT I WROTE ANYTHING WOULD BE MISLEADING.
`Q.
`RIGHT. BUT I'M JUST REFERRING TO THE SECOND
`PARAGRAPH, SECOND SENTENCE, WHERE IT STATES, "HER WORK ALONG
`WITH THE SUPPORT OF PAT MILES MADE THIS PUBLICATION POSSIBLE."
`DO YOU SEE THAT?
`A.
`YES.
`Q.
`YOU'RE PAT MILES?
`A.
`I AM HE.
`Q.
`OKAY.
`NOW, LET'S GO BACK TO THE TOP OF THE ACKNOWLEDGEMENTS
`PARAGRAPH. IT SAYS, "WE WOULD LIKE TO ACKNOWLEDGE THE WORK OF
`LUIZ PIMENTA WHO REALIZED THE POTENTIAL APPLICATIONS OF
`MINIMALLY INVASIVE LATERAL SURGERY OF THE SPINE."
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`A.
`Q.
`
`DO YOU SEE THAT?
`YES, SIR.
`OKAY.
`NOW, CAN YOU TURN TO, OH, THE PAGE -- IF YOU LOOK AT
`THE LOWER RIGHT-HAND CORNER OF THESE THINGS, OF THESE PAGES,
`THERE'S AN MNUV NUMBER. DO YOU SEE THAT?
`A.
`I DO.
`Q.
`WE CALL THOSE BATES NUMBERS. AND IF YOU CAN TURN TO
`THE ONE NUMBERED 82166. YOU WITH ME?
`A.
`GETTING THERE. OKAY.
`Q.
`DAVE, CAN YOU BLOW UP THE LAST TWO SENTENCE ON THAT
`PAGE? AND THERE'S A STATEMENT THERE. DO YOU SEE IT?
`IT SAYS, "THE XLIF TECHNIQUE WAS FIRST PRESENTED BY
`LUIZ PIMENTA IN 2001 AS A MINIMALLY INVASIVE PROCEDURE FOR
`INTERBODY FUSIONS ABOVE L5."
`DO SEE THAT?
`I DO.
`A.
`AND DO YOU RECALL THAT SPECIFICALLY WE'RE TALKING
`Q.
`ABOUT MAY OF 2001 WHEN HE PRESENTED IT?
`A.
`I DON'T SPECIFICALLY RECALL WHEN HE PRESENTED IT.
`Q.
`OKAY.
`YOU SEE THAT THERE'S A FOOTNOTE NEXT TO THE 2001?
`25, YEAH.
`A.
`YUP. AND IF YOU GO TO THE PAGE BATES STAMPED
`Q.
`82172 -- GOT IT? SEE THE FOOTNOTES?
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`A.
`Q.
`
`I DO.
`A.
`25?
`Q.
`YUP.
`A.
`"PIMENTA, L, LATERAL ENDOSCOPIC TRANSPSOAS
`Q.
`RETROPERITONEAL APPROACH FOR LUMBAR SPINE SURGERY PRESENTED AT
`THE EIGHTH BRAZILIAN SPINE SOCIETY MEETING, BRAZIL, MAY 2001."
`ALL RIGHT?
`I SEE IT, YES.
`OKAY.
`AND THEN BACK TO THE NOVEMBER PRESS RELEASE, CAN YOU
`PUT THAT BACK UP? CAN YOU BLOW UP THE SECOND TO THE LAST
`PARAGRAPH AGAIN? IT'S NOT THAT ONE. THINK MAYBE THE LAST ONE.
`THERE WE GO. AND IT'S YOUR TESTIMONY THAT THE REFERENCE IN
`THIS PRESS RELEASE TO THE MINIMALLY INVASIVE XLIF EXTREME
`LATERAL INTERBODY FUSION APPROACH TO THE SPINE DEVELOPED BY
`NUVASIVE WAS NOT THE XLIF PROCEDURE THAT IS BEING CREDITED TO
`DR. LUIZ PIMENTA AS OF MAY 2001 IN YOUR TEXTBOOK?
`A.
`I'M TESTIFYING THAT THOSE ARE COMPLETELY INDEPENDENT
`EVENTS.
`Q.
`
`OKAY.
`SO AGAIN, THE MINIMALLY INVASIVE XLIF PROCEDURE
`REFERENCED IN YOUR 2001 PRESS RELEASE HAS NOTHING TO DO WITH
`DR. LUIZ PIMENTA; IS THAT YOUR TESTIMONY?
`A.
`THAT IS MY TESTIMONY.
`Q.
`OKAY.
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`EVEN THOUGH IN THE ACKNOWLEDGEMENT YOU CREDIT DR.
`LUIZ PIMENTA AS HAVING PIONEERED XLIF; AM I CORRECT?
`A.
`THAT IS CORRECT.
`Q.
`NOW, WHAT YOU DID NOT HAVE WHEN YOU LAUNCHED, OR BACK
`IN NOVEMBER 2001, WAS THE COROENT IMPLANT; AM I CORRECT?
`A.
`THAT'S CORRECT.
`Q.
`THE COROENT IMPLANT CAME LATER?
`A.
`THAT'S CORRECT.
`Q.
`AND THE COROENT IMPLANT CAME IN 2003?
`A.
`NOT TO MY RECOLLECTION.
`Q.
`ALL RIGHT.
`AND WHAT YOU DID NOT HAVE IN 2001 WAS MAXCESS; AM I
`
`CORRECT?
`I BELIEVE YOU'RE CORRECT.
`A.
`MAXCESS ALSO CAME LATER, BUT YOU DID HAVE MAXCESS IN
`Q.
`OCTOBER OF 2003?
`A.
`THAT'S CORRECT.
`Q.
`SO WHEN XLIF BECAME SAFE AND REPRODUCIBLE FOR LAUNCH
`IN OCTOBER 2003, YOU HAD COROENT AND YOU HAD MAXCESS;
`CORRECT?
`IT'S CORRECT, BUT IT WASN'T BASED SPECIFICALLY ON
`A.
`HAVING THOSE TWO ELEMENTS.
`Q.
`WELL, WAS THE XLIF 60 NOT SAFE AND REPRODUCIBLE IN
`NOVEMBER 2001?
`A.
`NOT IN THE HANDS OF THE MASSES.
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`Q.
`A.
`Q.
`A.
`Q.
`
`NOT IN THE HANDS OF WHO?
`THE MANY.
`NOT IN THE HANDS OF THE MASSES?
`YES.
`I'M NOT FOLLOWING YOU.
`SO XLIF 60 WAS NOT SAFE AND REPRODUCIBLE IN THE HANDS
`OF THE MASSES?
`A.
`YES.
`Q.
`BUT XLIF -- WHAT WAS IT IN 2003? WHAT WAS THE
`PROCEDURE?
`A.
`XLIF 90.
`Q.
`XLIF 90 WAS SAFE AND REPRODUCIBLE IN THE HANDS OF THE
`MASSES?
`YES.
`A.
`THAT'S JUST BECAUSE OF NEUROVISION?
`Q.
`IT'S BECAUSE OF NEUROVISION AND JUST FUNDAMENTALLY
`A.
`THE REPRODUCIBILITY ASSOCIATED WITH THE APPROACH.
`Q.
`AND YOU'RE NOT GOING TO GIVE COROENT ANY CREDIT?
`A.
`ABOUT BEING SAFE?
`Q.
`THE SUCCESS OF XLIF, MR. MILES, ARE YOU GOING TO GIVE
`THE COROENT IMPLANT -- WHAT'S ACTUALLY INSERTED INTO THE
`PATIENT -- ARE YOU GOING TO GIVE IT ANY CREDIT?
`A.
`IT'S PART OF THE PROCEDURE. ITS AN ELEMENT OF --
`Q.
`I UNDERSTAND.
`THE POINT OF THE PROCEDURE IS TO STICK SOMETHING IN A
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`PATIENT, RIGHT?
`A.
`NO. THE INTENT OF THE PROCEDURE IS TO RESTORE THE
`HEIGHT OF THE DISC SPACE, RESTORE THE ALIGNMENT OF THE SPINE
`AND FIX A PATIENT.
`Q.
`I UNDERSTAND THAT.
`BUT YOU DO THAT WITH AN IMPLANT, DON'T YOU?
`THE IMPLANT IS A COMPONENT OF THAT, YES.
`IS THERE ANYTHING ELSE THAT YOU PUT IN THE PATIENT?
`IT'S NOT A MATTER OF JUST PUTTING SOMETHING INTO THE
`
`A.
`Q.
`A.
`PATIENT.
`I UNDERSTAND THAT. BUT THE POINT OF THE PROCEDURE IS
`Q.
`TO PUT AN IMPLANT IN THE SPACE SO THAT THE INTERBODY SPACE IS
`ABLE TO HEAL, TO FUSE; CORRECT?
`A.
`AND TO ALIGN --
`Q.
`DO YOU USE NEUROVISION TO ALIGN?
`A.
`NO, BUT IT'S IMPERATIVE; YOU NEED IT TO GET THERE.
`Q.
`DO YOU USE MAXCESS TO ALIGN?
`A.
`YOU NEED IT FOR THE EXPOSURE TO GET THERE.
`Q.
`SURE. BUT WHAT'S ULTIMATELY USED TO ALIGN, AND
`WHAT'S ULTIMATELY USED TO PROVIDE STABILITY? IT'S THE IMPLANT,
`RIGHT?
`IT'S INSTRUMENTS THAT WILL REALIGN THE SPINE, AND
`A.
`THEN YOU PLACE AN IMPLANT TO FIX THE SPINE.
`Q.
`I UNDERSTAND. MY ONLY POINT IS THE POINT OF THE XLIF
`PROCEDURE ISN'T TO STICK AN ENDOSCOPIC INSTRUMENT, THE
`
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`RETRACTOR, IN A PATIENT; CORRECT? THAT'S NOT THE POINT OF THE
`PROCEDURE?
`ENDOSCOPIC INSTRUMENT -- ENDOSCOPIC INSTRUMENT HAS
`A.
`NOTHING TO DO WITH THE PROCEDURE ITSELF.
`Q.
`THE POINT OF THE XLIF PROCEDURE IS NOT TO STICK A
`RETRACTOR IN A PATIENT; AM I CORRECT?
`A.
`THE INTENT OF THE XLIF PROCEDURE IS TO RESTORE THE
`HEIGHT, THE ALIGNMENT AND FIX THE SPINE.
`Q.
`THE POINT OF THE XLIF PROCEDURE IS NOT TO STICK A
`RETRACTOR IN A PATIENT; AM I CORRECT?
`A.
`IT'S A CORE ELEMENT TO THE PROCEDURE. WHEN YOU SPEAK
`OF A PROCEDURE, YOU MUST SPEAK NOT ONLY OF THE IMPLANT. THE
`IMPLANT IS JUST A COMPONENT OF IT.
`Q.
`ALL RIGHT.
`SO IT'S YOUR TESTIMONY TO THIS JURY THAT PUTTING THE
`IMPLANT IN THE PATIENT IS JUST A SMALL PART OF THIS PROCEDURE;
`THAT'S NOT THE POINT OF THE PROCEDURE?
`A.
`MY TESTIMONY TO THE JURY IS THAT THE IMPLANT IS THE
`FINAL THING YOU PLACE. WITHOUT GETTING TO THE SPINE SAFELY AND
`REPRODUCIBLY, IT REALLY DOESN'T MATTER. IF YOU HAVE COMPLETE
`DISRUPTION ON THE WAY TO THE SPINE, IT DOESN'T MATTER WHAT YOU
`PUT IN THERE.
`Q.
`LET ME SHIFT GEARS. I'LL COME BACK TO THAT IN A
`LITTLE BIT HERE. I WANT TO GET A COUPLE HOUSEKEEPING THINGS
`OUT OF THE WAY.
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`THE '236 PATENT, YOU'RE FAMILIAR WITH IT,
`MR. MILES?
`A.
`YOU'D HAVE TO SHOW IT TO ME.
`Q.
`YOU'VE NEVER HEARD OF THE '236 PATENT?
`A.
`I'VE HEARD OF THE '236 PATENT. I'VE 38 OR SO
`PATENTS.
`YOU'RE THE PRESIDENT OF THE AMERICAS?
`Q.
`YES, I AM.
`A.
`YOU'RE FAMILIAR WITH THIS LAWSUIT?
`Q.
`YES, I AM.
`A.
`YOU UNDERSTAND THERE'S A PATENT BEING ASSERTED BY
`Q.
`NUVASIVE IN THIS LAWSUIT AGAINST MEDTRONIC SOFAMOR DANEK, USA?
`A.
`I DO.
`Q.
`AND YOU KNOW THAT THE PATENT IS THE '236 PATENT
`RELATING TO NEUROMONITORING; DO YOU NOT?
`A.
`I DO.
`Q.
`I'M SORRY?
`A.
`YES, SIR.
`Q.
`YOU DO?
`A.
`YOU ASKED ME IF I KNEW THE ELEMENTS OF THE PATENT.
`Q.
`I DIDN'T ASK YOU THAT.
`A.
`I MISUNDERSTOOD YOU THEN.
`Q.
`SURE. YOU MISUNDERSTOOD ME. THAT'S ALL RIGHT.
`NOW ON THE '236 PATENT, MR. MILES, IT IS A FACT, IS
`IT NOT, THAT THE METHODS OF THE ISSUED CLAIMS OF THE '236
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`PATENT WERE NOT PERFORMED BY ANY PERSON USING ANY NUVASIVE
`PRODUCT; IS THAT CORRECT, SIR?
`A.
`CAN YOU PLEASE RESTATE THAT?
`Q.
`SURE.
`IT'S A FACT, IS IT NOT, MR. MILES, THAT THE METHODS
`OF THE ISSUED CLAIMS OF THE '236 PATENT WERE NOT PERFORMED BY
`ANY PERSON USING ANY NUVASIVE PRODUCT; AM I CORRECT?
`A.
`NOT TO MY KNOWLEDGE.
`Q.
`SO I AM CORRECT?
`A.
`TO MY KNOWLEDGE, YOU'RE CORRECT.
`Q.
`ALL RIGHT.
`NOW, YOU UNDERSTAND THAT NUVASIVE IN THE OPENING
`STATEMENT HERE HAS SAID THAT SOFAMOR DANEK COPIES THE NUVASIVE
`NEUROVISION SYSTEM BY INFRINGING THE '236 PATENT?
`A.
`I WASN'T HERE DURING THE OPENING STATEMENTS. SO I'M
`NOT SURE WHAT WAS SAID.
`Q.
`YOU'LL AGREE WITH ME THAT IF NUVASIVE DOESN'T
`PRACTICE THE '236 PATENT, AND SOFAMOR DANEK DOES PRACTICE THE
`'236 PATENT, SOFAMOR DANEK ISN'T COPYING WHAT NUVASIVE IS
`DOING; IS THAT LOGICAL?
`A.
`YEAH, I WOULD LEAVE IT TO YOU GUYS TO FIGURE THAT
`OUT.
`Q.
`
`OKAY.
`NOW NEUROMONITORING IS DESIGNED TO DEAL WITH THE
`PSOAS MUSCLE; AM I CORRECT?
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`YES, GENERALLY.
`A.
`NOW, THE PSOAS MUSCLE IS NOT AN ISSUE ALONG THE
`Q.
`ENTIRE SPINE; AM I CORRECT?
`A.
`IN WHAT CONTEXT?
`Q.
`ANY CONTEXT.
`A.
`IS IT NOT AN ISSUE ALONG THE ENTIRE SPINE?
`Q.
`YES, SIR.
`A.
`I WOULD NEED MORE INFORMATION TO APPRECIATE, YOU
`KNOW, EXACTLY WHAT YOU'RE TALKING ABOUT.
`Q.
`SURE.
`YOU'RE FAMILIAR WITH THE L1-L2 REGION OF THE SPINE?
`YES, I AM.
`THE PSOAS MUSCLE DOESN'T FACTOR INTO THAT REGION,
`
`A.
`Q.
`DOES IT?
`A.
`ELEMENTS?
`Q.
`THERE?
`IT BECOMES -- AS YOU GO UP THE SPINE, ANATOMICALLY,
`A.
`IT'S OF LESS AND LESS -- SHOULDN'T SAY OF LESS AND LESS
`IMPORTANCE. THERE'S LIKELY LESS ANOMALIES IN THE NEURO
`ELEMENTS.
`Q.
`LIKELY LESS ANOMALY IN THE NEURO ELEMENTS?
`A.
`IT MEANS THAT THE LIKELIHOOD OF HAVING NERVES IN THE
`WAY OF A DISC PACE OF L1 IS DIFFERENT THAN HAVING NERVES IN THE
`
`IN WHAT CAPACITY? AS IT RELATES TO THE NEURO
`
`AS IT RELATES TO NEEDING NEUROVISION TO GET THROUGH
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`WAY OF, SAY, L4-5.
`Q.
`DR. SMITH IS A CONSULTANT WITH THE COMPANY. DO YOU
`KNOW DR. SMITH?
`A.
`I KNOW DR. SMITH.
`Q.
`DR. SMITH SAID, ABOVE THE L3-L4 REGION, YOU CAN DO
`WITH OR WITHOUT NEUROVISION.
`DO YOU AGREE WITH THAT?
`I THINK IF YOU ASKED A LOT OF SURGEONS, YOU'D GET A
`A.
`LOT OF DIFFERENT ANSWERS.
`Q.
`I'M ASKING YOU, DO YOU AGREE WITH YOUR OWN
`CONSULTANT, DR. SMITH, THAT ABOVE THE L3-L4 REGION YOU CAN DO
`WITH OR WITHOUT NEUROVISION; DO YOU AGREE WITH HIM OR DISAGREE
`WITH HIM?
`A.
`I DISAGREE WITH HIM.
`Q.
`YOU DISAGREE WITH HIM?
`A.
`YES.
`Q.
`OKAY.
`DR. FOLEY, HE WAS A CONSULTANT TO YOU ON THE, FOR
`NEUROMONITORING; CORRECT?
`A.
`YES.
`Q.
`DR. FOLEY SAYS THAT THE QUESTION OF WHETHER OR NOT
`YOU NEED NEUROVISION FOR PURPOSES OF DEALING THE PSOAS IS STILL
`AN ISSUE. IT'S AN ISSUE OF DEBATE OUT THERE IN THE MEDICAL
`COMMUNITY. DO YOU AGREE OR DISAGREE WITH DR. FOLEY, YOUR
`CONSULTANT?
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`DR. FOLEY HAS NEVER DONE AN XLIF, TO MY KNOWLEDGE.
`A.
`SO I WOULD DISAGREE WITH HIM. HE DOESN'T HAVE THE EXPERIENCE
`TO, YOU KNOW, HAVE A CREDIBLE COMMENT, IN MY MIND.
`Q.
`SO DR. FOLEY, THE CONSULTANT YOU HIRED FOR PURPOSES
`OF NEUROMONITORING CANNOT OFFER A CREDIBLE OPINION ON THE
`SUBJECT OF THE NEUROMONITORING; THAT'S YOUR TESTIMONY?
`A.
`THAT'S MY TESTIMONY, YES.
`Q.
`I'M SORRY?
`A.
`YES, THAT IS.
`Q.
`THAT IS YOUR TESTIMONY; OKAY.
`IT IS A FACT THAT NUVASIVE SELLS IMPLANTS FOR USE IN
`THE THORACIC AND UPPER LUMBAR; CORRECT?
`A.
`THAT IS CORRECT.
`Q.
`MR. MILES, DO YOU HAVE A POLICY AT NUVASIVE THAT YOU
`WILL NOT SELL YOUR COROENT IMPLANTS UNLESS THE HOSPITAL USES
`YOUR BRAND OF NEUROMONITORING, THE NEUROVISION SYSTEM?
`A.
`WE HAVE A POLICY THAT DOES NOTHING BUT DRIVES THE
`HIGHEST LIKELIHOOD FOR SAFETY AND REPRODUCIBILITY; AND SEEING
`THAT NEUROVISION IS THE ONLY DEVICE THAT HAS BEEN ASSEMBLED TO
`A TECHNIQUE, WE HAVE A POLICY, YES. IT SAYS, NEUROVISION
`SHOULD BE THE ONLY NEUROPHYSIOLOGY USED WITH XLIF.
`Q.
`YOU SAID THAT SEEING THAT NEUROVISION IS THE ONLY
`SYSTEM -- WHAT DID YOU SAY? SOMETHING ASSEMBLED TO THE
`TECHNIQUE?
`A.
`WHAT I'M SAYING IS THAT THROUGH YEARS OF EXPERIENCE
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`AND THOUSANDS OF CASES WE HAVE VALIDATED THE SAFETY AND
`REPRODUCIBILITY OF NEUROVISION AS A TOOL WITH XLIF. SO WE
`BELIEVE STRONGLY THAT IF THAT IS OUR EXPERIENCE, WE OWE THE
`SURGEON THAT LEVEL OF CONFIDENCE.
`Q.
`SO IF YOU WANT A COROENT, YOU HAVE TO BUY THE
`NEUROVISION EQUIPMENT; IS THAT RIGHT?
`A.
`IT'S BACK TO WHAT I SAID. THE COROENT IS NOT THE MAIN
`ELEMENT OF THE PROCEDURE. IT IS AN ASSEMBLED GROUP OF THINGS
`THAT MAKES THE THING SUCCESSFUL.
`Q.
`THAT'S RIGHT. PEOPLE GET SURGERY TO GET
`NEUROMONITORING; THAT'S WHAT YOU'RE SAYING.
`A.
`IF THAT'S THE CONTEXT THAT YOU'D LIKE TO SAY IT.
`Q.
`YOU'RE TELLING ME THAT PEOPLE DON'T GET THE SURGERY
`TO GET THE IMPLANT?
`A.
`THAT'S NOT TRUE.
`Q.
`THAT'S NOT TRUE. THEY GET THE SURGERY TO GET THE
`IMPLANT?
`A.
`
`WHAT I'M TELLING YOU, AND YOU CAN MAKE A MOCKERY OF
`
`IT --
`
`Q.
`
`I'M NOT MAKING A MOCKERY OF IT, MR. MILES.
`THE COURT: LET ME GET INVOLVED IN THIS NOW. IT
`SEEMS TO ME THAT WE'RE GENERATING INTO AN ARGUMENT HERE. SO
`MAYBE WE CAN DIAL IT BACK A LITTLE BIT AND JUST GET BACK ON A
`QUESTION-AND-ANSWER MOTIF INSTEAD OF PICKING AT EACH OTHER.
`WHAT DO YOU THINK? IS THAT FAIR?
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`MR. DAUCHOT: WILL DO. FAIR ENOUGH.
`BY MR. DAUCHOT:
`Q.
`MR. MILES, YOU GRADUATED FROM COLLEGE IN MACON,
`GEORGIA; AM I RIGHT?
`A.
`YES, SIR.
`Q.
`AND YOU HAVE A DEGREE IN FINANCE?
`A.
`I DO.
`Q.
`AND YOU HAVE NO FURTHER FORMAL EDUCATION AFTER
`THAT?
`NO.
`A.
`AND DID YOU HAVE ANY ADDITIONAL FORMAL -- YOU'RE NOT
`Q.
`A BIOMECHANICAL ENGINEER?
`A.
`NO, SIR.
`Q.
`YOU'RE NOT AN ENGINEER?
`A.
`NO, SIR.
`Q.
`AND YOU'RE NOT A DOCTOR?
`A.
`NO.
`Q.
`BUT YOU ARE THE PERSON THAT YOU MOST RECOLLECT AS
`HAVING DEVELOPED COROENT?
`A.
`YES.
`Q.
`NOW THERE'S BEEN TESTIMONY TODAY THAT, TESTIMONY
`TODAY BY DR. SMITH THAT COROENT WAS VERY INNOVATIVE BY VIRTUE
`OF ITS LENGTH; NAMELY, THAT IT SPANNED THE ENTIRE TRANSVERSE
`WIDTH OF THE VERTEBRAL BODY; DO YOU AGREE WITH HIM?
`A.
`THAT IT WAS INNOVATIVE?
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`YES.
`Q.
`YES.
`A.
`BECAUSE HE SAID IT SPANNED THE ENTIRE WIDTH OF THE
`Q.
`VERTEBRA BECAUSE IT WAS TRANSLATERAL, COAST TO COAST; DO YOU
`AGREE WITH THAT?
`A.
`I THINK THERE'S MANY ELEMENTS THAT MAKE IT
`INNOVATIVE.
`Q.
`MY QUESTION IS: IS IT A FACT DR. SMITH SAID THAT IT
`WAS INNOVATIVE BECAUSE IT SPANNED FROM COAST TO COAST; DO YOU
`AGREE WITH DR. SMITH?
`A.
`I AGREE WITH DR. SMITH THAT IT'S IMPORTANT TO GO ALL
`THE WAY ACROSS A DISC SPACE AND SIT ON THE RING OF APOPHYSIS,
`YES, I DO.
`Q.
`MY QUESTION IS, DR. SMITH SAID IT WAS INNOVATIVE
`BECAUSE IT SPANNED FROM COAST TO COAST AND THAT HE HAD NOT SEEN
`SOMETHING LIKE THAT BEFORE; HE SAID IT WAS INNOVATIVE. MY
`QUESTION IS, DO YOU AGREE WITH DR. SMITH, YOUR CONSULTANT, THAT
`THE COROENT IMPLANT WAS INNOVATIVE BY VIRTUE OF SPANNING FROM
`COAST TO COAST?
`MR. SCHERKENBACH: OBJECTION, YOUR HONOR. IT'S
`ARGUMENTATIVE AND LACKS FOUNDATION.
`THE COURT: OVERRULED. GO AHEAD.
`THE WITNESS: SOLELY, NO. THAT'S NOT THE ONLY
`INNOVATIVE ELEMENT OF THE IMPLANT.
`BY MR. DAUCHOT:
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`THAT IS NOT THE INNOVATIVE --
`Q.
`THAT IS NOT THE ONLY ELEMENT.
`A.
`IS IT AN INNOVATIVE ELEMENT OF THE IMPLANT? CAN YOU
`Q.
`GIVE US THAT?
`A.
`IS IT AN INNOVATIVE PORTION?
`Q.
`YES, SIR.
`A.
`I BELIEVE SO.
`Q.
`OKAY.
`NOW YOU TAKE CREDIT FOR DEFINING THE REQUIREMENTS FOR
`THE LENGTHS THAT THE COROENT EXCEL COMES IN, DO YOU NOT?
`THAT'S SOMETHING THAT YOU CREDIT TO YOURSELF?
`A.
`YES, SIR.
`Q.
`BUT YOU DON'T REMEMBER WHEN YOU CONCEIVED OF THAT
`IDEA; AM I CORRECT?
`A.
`NOT 11 YEARS AGO I DON'T.
`Q.
`NOW, THE FACT IS THAT IMPLANTS SIZED LIKE COROENT HAD
`BEEN USED IN SURGERIES DURING THE '90S, AM I CORRECT, DURING
`THE 1990'S?
`A.
`NOT TO MY RECOLLECTION.
`Q.
`DO YOU HAVE ANY KNOWLEDGE THAT SOFAMOR DANEK, THE
`COMPANY YOU USED TO WORK FOR, WAS WORKING IN THIS AREA BOTH IN
`THE STATES AND IN EUROPE?
`A.
`IN WHAT AREA?
`Q.
`IN THE AREA OF INTERBODY FUSION AND SELLING THE LONG
`CAGES, THE COAST-TO-COAST CAGES; DO YOU HAVE ANY MEMORY OF
`
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`THAT?
`NO MEMORY WHATSOEVER.
`A.
`QUICK QUESTION ON MAXCESS. THE PIVOTING FEATURE OF
`Q.
`THE MAXCESS TWO WAS CARRIED OVER TO THE MAXCESS THREE
`RETRACTOR; AM I CORRECT?
`A.
`YES.
`Q.
`AND THAT WAS DONE, THE PIVOTING FEATURE, WAS MOVED
`FROM MAXCESS TWO TO MAXCESS THREE BECAUSE THERE WAS A FEELING
`AS THOUGH IT WAS A VALUABLE FEATURE SET FOR CERTAIN
`APPLICATIONS; AM I CORRECT?
`A.
`YES.
`Q.
`AND NUVASIVE IS DESIGNING A MAXCESS FOUR RETRACTOR;
`AM I CORRECT?
`A.
`YES.
`Q.
`AND A NEXT GENERATION; IT'S STILL UNDER
`DEVELOPMENT?
`A.
`NO.
`Q.
`IT'S NOT GOING TO BE LAUNCHED?
`A.
`WE'VE ALREADY LAUNCHED IT.
`Q.
`AND WHEN DID YOU LAUNCH IT?
`A.
`A MONTH OR SO AGO.
`Q.
`YOU LAUNCHED IT A MONTH OR SO AGO. AND IT HAS THE
`PIVOTING FEATURE?
`A.
`MAXCESS FOUR HAS THE PIVOTING FEATURE.
`Q.
`I TAKE IT YOU HAVE THE PIVOTING FEATURE IN THERE
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`BECAUSE YOU SEE IT AS VALUABLE?
`A.
`YES. THE INDEPENDENT PIVOTING OF BLADES IS
`VALUABLE.
`Q.
`AND YOU DON'T CONSIDER IT DANGEROUS, THE PIVOTING OF
`THE BLADES?
`A.
`IT DEPENDS ON HOW YOU USE IT.
`Q.
`ALL RIGHT.
`MR. OJEDA, MARK OJEDA, DO YOU KNOW HIM?
`I DO.
`HE USED TO WORK WITH YOU AT SOFAMOR DANEK; IS THAT
`
`A.
`Q.
`RIGHT?
`A.
`Q.
`CORRECT?
`A.
`Q.
`CORRECT?
`HE DOES.
`A.
`MR. OJEDA -- YOU WERE PERSONALLY INVOLVED AT NUVASIVE
`Q.
`IN THE DEVELOPMENT OF THE HELIX PLATE; AM I CORRECT?
`A.
`AT NUVASIVE, YES.
`Q.
`AND THE HELIX PLATE WAS DEVELOPED, WHAT, IN 2006-ISH,
`'7-ISH?
`A.
`Q.
`
`CORRECT.
`MR. OJEDA REPORTED TO YOU AT SOFAMOR DANEK; AM I
`
`HE DID.
`MR. OJEDA NOW WORKS WITH YOU AT NUVASIVE; AM I
`
`SOMETHING LIKE THAT.
`AFTER MR. OJEDA CAME ON BOARD; CORRECT?
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`I BELIEVE SO, YES.
`A.
`NOW, THE HELIX PLATE USES A COIL LOCKING MECHANISM;
`Q.
`AM I CORRECT?
`A.
`YES.
`Q.
`IT'S THE ONLY LOCKING MECHANISM THAT YOU CAN RECALL
`NUVASIVE EVER CONSIDERING FOR IT'S HELIX PLATE; AM I CORRECT?
`A.
`IT'S -- THE NAME HELIX CAME AFTER THE DEFINITION OF
`THE LOCKING MECHANISM. SO AS IT RELATES TO -- THE NAME CAME
`AFTER THE LOCKING MECHANISM. SO WE WENT THROUGH MANY LOCKING
`MECHANISMS BEFORE WE EVER GOT TO A HELICAL COIL.
`Q.
`DURING THE DEVELOPMENT OF THE HELIX PLATE, DO YOU
`RECALL ANY OTHER LOCKING MECHANISM THAT NUVASIVE CONSIDERED
`OTHER THAN THE COIL?
`A.
`I DO.
`Q.
`CAN YOU PLEASE RUN CLIP 18?
`(VIDEO WAS PLAYED.)
`"QUESTION: DURING DEVELOPMENT OF THE HELIX PLATE, DO
`YOU RECALL ANY OTHER LOCKING MECHANISM THAT NUVASIVE
`CONSIDERED OTHER THAN THE COIL.
`ANSWER: I REALLY DON'T."
`BY MR. DAUCHOT:
`Q.
`ALL RIGHT.
`MR. MILES, NUVASIVE DECIDED TO USE A COIL BECAUSE IT
`ACCOMMODATED THE ORIGINAL REQUIREMENTS FOR THE HELIX AS DEFINED
`BY MARK OJEDA; AM I CORRECT?
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`A.
`Q.
`
`CAN YOU PLEASE RESTATE THE QUESTION?
`SURE.
`NUVASIVE DECIDED TO USE THE COIL BECAUSE IT
`ACCOMMODATED THE ORIGINAL REQUIREMENTS FOR THE HELIX AS DEFINED
`BY MARK OJEDA; AM I CORRECT?
`A.
`IT FULFILLED THE DESIGN REQUIREMENTS, THAT'S
`CORRECT.
`MY QUESTION IS, THE DESIGN REQUIREMENTS WERE
`Q.
`ESTABLISHED BY MARK OJEDA, DEFINED BY MARK OJEDA; AM I
`CORRECT?
`YEAH. IT'S TYPICAL THAT THE PERSON WHOSE MOST
`A.
`RESPONSIBLE FOR THE MARKETING OF THE DEVICE RIGHTS THE
`REQUIREMENTS.
`Q.
`AND THAT WAS MARK OJEDA?
`A.
`YES, SIR, IT WAS.
`Q.
`HE CAME UP WITH THE COIL?
`A.
`HE DIDN'T COME UP WITH THE COIL, NO.
`Q.
`HE DEFINED THE COIL AS A REQUIREMENT?
`A.
`NO, HE DIDN'T DEFINE THE COIL AS A REQUIREMENT. HE
`DEFINED THE REQUIREMENT OF A LOCKING MECHANISM.
`Q.
`ALL RIGHT. CAN WE RUN CLIP 19 PLEASE?
`(A DISCUSSION WAS HELD BETWEEN COUNSEL.)
`MR. DAUCHOT: PLEASE RUN CLIP 19.
`(THE VIDEO WAS PLAYED.)
`"QUESTION: DO YOU KNOW WHY NUVASIVE DECIDED TO USE A
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`COIL.
`
`ANSWER: YES.
`QUESTION: AND WHY IS THAT.
`ANSWER: I BELIEVE IT ACCOMMODATED THE ORIGINAL
`REQUIREMENTS AS DEFINED BY MARK."
`BY MR. DAUCHOT:
`Q.
`AND THAT WAS MARK OJEDA?
`A.
`YES, SIR. HE DEFINED THE REQUIREMENT FOR A LOCKING
`MECHANISM.
`Q.
`FOR THE C