Case 3:08-cv-01512-CAB-MDD Document 391 Filed 09/20/11 PageID.18489 Page 1 of 133
`
`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.
`. SEPTEMBER 7, 2011.
`.
`NUVASIVE, INC.,
`. WEDNESDAY, 1:30 P.M.
`.
`DEFENDANT.
`. TRIAL - DAY SIX
`. . . . . . . . . . . . . . . . . ..
`
`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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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1056, p. 1 of 9
`
`
`
`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.
`. SEPTEMBER 7, 2011.
`.
`NUVASIVE, INC.,
`. WEDNESDAY, 1:30 P.M.
`.
`DEFENDANT.
`. TRIAL - DAY SIX
`. . . . . . . . . . . . . . . . . ..
`
`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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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1056, p. 1 of 9
`
`
`
`Case 3:08-cv-01512-CAB-MDD Document 391 Filed 09/20/11 PageID.18490 Page 2 of 133
`08-CV-1512
`
`INDEX - 08-CV-1512
`MEDTRONIC V. NUVASIVE, 9/7/11
`
`WITNESSES:
`
` DIRECT CROSS REDIRECT RECROSS
`
` 1348 1368 1376
`DR. STEPHEN RAYMOND
`DR. WILLIAM DOUGLAS SMITH 1380 1423 1438
`
`DR. JOHN W. BRANTIGAN
` 1443
`
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1056, p. 2 of 9
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`Case 3:08-cv-01512-CAB-MDD Document 391 Filed 09/20/11 PageID.18607 Page 119 of
` 133
`08-CV-1512
`
`COULD YOU DESCRIBE THE BAK CAGE?
`Q.
`THE BAK CAGE IS A CYLINDRICAL DEVICE THAT WAS
`A.
`INSERTED EITHER FROM THE BACK, WHICH IS THIS DIRECTION, OR FROM
`THE FRONT, WHICH WAS THAT DIRECTION. AND THEY WERE CIRCULAR
`DOWL SHAPED STRUCTURES THAT WERE INSERTED THROUGH A BIG DRILL
`HOLE IN THE DISC SPACE. THE DRILL HOLE CUT DEEPLY INTO THE
`VERTEBRAL BODY ABOVE AND BELOW, AND THEY WERE SIDE BY SIDE.
`Q.
`IN THIS TIME FRAME, LATE 1980S, EARLY 1990S, WHICH
`ARTIFICIAL SPINE IMPLANTS WERE YOU AWARE OF THAT WERE IN USE
`FOR INTERBODY FUSION SURGERY?
`A.
`IN THAT TIME FRAME, THERE WERE SEVERAL PEOPLE THAT
`WERE WORKING DILIGENTLY TO DEVELOP INTERBODY FUSION DEVICES.
`IN ADDITION TO MINE, DR. STEVE KUSLICH WAS DEVELOPING THE BAK
`CAGE; CHARLIE RAY WAS DEVELOPING THE RAY FUSION CAGE; GEORGE
`BAGBY WAS DEVELOPING A DEVICE FOR USE IN RACE HORSES; AND
`JURGEN HARMS FROM GERMANY WAS DEVELOPING A SURGICAL MESH MADE
`OF TITANIUM THAT DID THE SAME THING.
`Q.
`IN THE 1993 TO 1995 TIME PERIOD, DID YOU TEACH AT
`MEETINGS WHERE INTERBODY FUSION DEVICES WHERE THE MAIN TOPIC OF
`CONVERSATION?
`A.
`YES, I DID.
`Q.
`ABOUT HOW MANY OF THESE MEETING DID YOU TEACH AT?
`A.
`ABOUT FOUR OR FIVE IN THOSE EARLY YEARS.
`Q.
`WHO WERE THE OTHER INSTRUCTORS OR PRESENTERS AT THESE
`MEETINGS?
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1056, p. 3 of 9
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`Case 3:08-cv-01512-CAB-MDD Document 391 Filed 09/20/11 PageID.18609 Page 121 of
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`08-CV-1512
`
`WHY DID YOU THINK THAT?
`Q.
`BECAUSE WE HAD NUMEROUS MEETINGS WHERE THE PEOPLE
`A.
`INVOLVED IN THIS DEVELOPMENT ALL KNEW EACH OTHER.
`MR. DAUCHOT: OBJECTION. HE IS A FACT WITNESS NOT AS
`AN EXPERT.
`THE COURT: WELL, I THINK HE'S TELLING US ABOUT HIS
`OWN EXPERIENCE AND HIS OWN KNOWLEDGE AT THIS TIME. SO
`OVERRULED AT THIS POINT. GO AHEAD.
`THE WITNESS: BUT ALSO I AND COLLEAGUES WORKING WITH
`ACROMED HAD HAD THE EXPERIENCE OF USING MY OVAL IMPLANTS FOR
`LATERAL INTERBODY FUSION STARTING IN 1990, FIVE YEARS BEFORE
`DR. MICHAELSON FILED HIS PATENT APPLICATION.
`BY MR. MILLER:
`Q.
`DID YOU EVENTUALLY LEAVE YOUR POSITION AT CREIGHTON
`UNIVERSITY?
`A.
`YES, I DID.
`Q.
`WHEN WAS THAT?
`A.
`1997.
`Q.
`WHAT DID YOU DO NEXT?
`A.
`I JOINED A GROUP IN SAN ANTONIO, SOUTH TEXAS
`ORTHOPAEDIC AND SPINAL SURGERY ASSOCIATES.
`Q.
`HOW LONG DID YOU REMAIN IN THAT PRACTICE?
`A.
`UNTIL 2004.
`Q.
`WAS THAT A FAIRLY BUSY PRACTICE?
`A.
`YES, IT WAS.
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`IPR2019-00362, Ex. 1056, p. 4 of 9
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`Case 3:08-cv-01512-CAB-MDD Document 391 Filed 09/20/11 PageID.18611 Page 123 of
` 133
`08-CV-1512
`
`WHO TOOK THIS PICTURE?
`Q.
`I DID.
`A.
`WHEN?
`Q.
`THAT WAS IN 1991 AFTER WE FORMALIZED THE STANDARD
`A.
`DIMENSIONS.
`Q.
`HOW DID YOU COME UP WITH THE SHAPE OF THE IMPLANT?
`A.
`THE SHAPE, THE OVAL SHAPE, IS SIZED AND SHAPED TO FIT
`THE INTERVERTEBRAL SPACE WHERE THE DISC IS.
`Q.
`WHEN DID YOU BEGIN DEVELOPING THESE IMPLANTS?
`A.
`ABOUT 1988.
`Q.
`WHO MANUFACTURED THE IMPLANTS THAT WE SEE IN
`DTX5118?
`THOSE WERE MADE BY ACROMED CORPORATION IN
`A.
`CLEVELAND.
`Q.
`DID THE FDA APPROVE THESE IMPLANTS?
`A.
`THEY WERE APPROVED IN 2003.
`Q.
`WHEN WAS YOUR OVAL IMPLANTS, THESE IMPLANTS IN 5118,
`WHEN WAS IT FIRST USED IN THE UNITED STATES?
`A.
`JULY OF 1990.
`Q.
`WERE THESE IMPLANTS AVAILABLE IN COUNTRIES OTHER THAN
`THE UNITED STATES IN THE EARLY 1990S?
`A.
`YES.
`Q.
`WHERE?
`A.
`WE MADE THEM AVAILABLE IN EUROPE IN 1991 AND
`AUSTRALIA IN ABOUT 1992.
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1056, p. 5 of 9
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`Case 3:08-cv-01512-CAB-MDD Document 391 Filed 09/20/11 PageID.18612 Page 124 of
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`08-CV-1512
`
`AND THESE IMPLANTS THAT WERE MADE AVAILABLE ABROAD,
`Q.
`WERE THEY MADE AVAILABLE BY ACROMED?
`A.
`YES, THEY WERE.
`Q.
`WERE THEY ARE MANUFACTURED?
`A.
`THEY WERE INITIALLY MANUFACTURED IN CLEVELAND.
`Q.
`AND THE IMPLANTS THAT YOU USED IN 1990, WHERE WERE
`THEY MANUFACTURED?
`A.
`THEY WERE MANUFACTURED IN CLEVELAND.
`Q.
`NOW, HOW DO YOU KNOW THAT YOUR IMPLANTS, THESE OVAL
`IMPLANTS, WERE USED IN EUROPE AND AUSTRALIA?
`A.
`PART OF MY JOB WITH ACROMED WAS TO TRAVEL AND TEACH
`THE USE OF THESE IMPLANTS. SO AT THAT TIME FRAME, I HAD ONE
`OUT OF TOWN TRIP PER MONTH ON THE AVERAGE. ABOUT HALF OF THEM
`WERE IN THE UNITED STATES AND HALF OF THEM WERE ABROAD. SO I
`TALKED TO SURGEONS IN EUROPE AND IN AUSTRALIA.
`Q.
`EVEN THOUGH YOU'RE THE INVENTOR OF THESE IMPLANTS,
`DID YOU NEED TO WRITE A PRESCRIPTION TO ACROMED TO GET THEM FOR
`SURGERY?
`A.
`Q.
`
`YES.
`COULD YOU BRING UP DX5134, PLEASE?
`IS THIS AN EXAMPLE OF ONE OF YOUR IMPLANTS -- I'M
`SORRY -- ONE OF YOUR PRESCRIPTIONS?
`A.
`YES, IT IS.
`Q.
`DOCTOR, I'M GOING TO COME STEAL YOUR LASER.
`DOCTOR, WHAT DO WE SEE IN THIS PRESCRIPTION? AND
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1056, p. 6 of 9
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`Case 3:08-cv-01512-CAB-MDD Document 391 Filed 09/20/11 PageID.18613 Page 125 of
` 133
`08-CV-1512
`
`MR. SAYERS, IF YOU COULD PULL UP THIS PART.
`A.
`WE SEE THE PATIENT'S NAME, THE DESCRIPTION OF THE
`PATIENT'S CONDITION. SHE HAD THE POSTERIOR LUMBAR INTERBODY
`FUSION WITH VSP PLATES AT L4-5 THROUGH S1. SHE HAD FAILURE AT
`L4-5, A REVISION USING THE RECTANGULAR CAGES AT L4-5, AND NOW
`THE ETHYLENE OXIDE STERILIZED BONE IS DISSOLVING AT L5-S1.
`CAGE FUSION WAS SOLID AT THE OTHER LEVEL. SHE NEEDED REPAIR OF
`THE FAILED POSTERIOR LUMBAR INTERBODY FUSION AT THE L5-S1 USING
`THE ANTERIOR CAGE DEVICE.
`MR. MILLER: MR. SAYERS, IF YOU COULD BRING UP THE
`BOTTOM HALF.
`BY MR. MILLER:
`Q.
`WHAT DOES THIS PART OF THE DOCUMENT TELL US?
`A.
`SO BASICALLY THIS INDIVIDUAL PRESCRIPTION REQUIRED US
`TO IDENTIFY A NEED FOR WHICH A STANDARD DEVICE WAS NOT
`AVAILABLE, AND WE'RE REQUESTING ANTERIOR OVAL CAGES DESCRIBED
`IN THE DRAWINGS THAT WERE INCLUDED. THE SMALL SIZE DESCRIBED,
`SMALL-12, WAS 33 MILLIMETERS BY 22 BY 12 MILLIMETERS HIGH. THE
`SMALL-10 WAS 33 BY 22 BY 10 MILLIMETERS HIGH. I LISTED THAT
`THE SURGERY WAS SCHEDULED FOR NOVEMBER 21, 1990.
`Q.
`DID YOU GET BOTH OF THESE IMPLANTS?
`A.
`YES, I DID.
`Q.
`I'M SORRY.
`DID YOU SAY THE PRESCRIPTION DATE?
`OCTOBER OF 1990.
`
`A.
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`Case 3:08-cv-01512-CAB-MDD Document 391 Filed 09/20/11 PageID.18614 Page 126 of
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`08-CV-1512
`
`Q.
`A.
`
`HOW DO WE KNOW WHAT THESE IMPLANTS LOOK LIKE?
`I HAD DRAWINGS WITH THEM.
`MR. MILLER: MR. SAYERS, IF YOU COULD BRING UP 2736,
`THE PAGE ON THIS DOCUMENT.
`BY MR. MILLER:
`Q.
`IS THIS ONE OF YOUR DRAWINGS?
`A.
`YES, IT IS.
`Q.
`NOW, DID YOU PROVIDE THIS DRAWING TO ACROMED?
`A.
`YES, I DID.
`Q.
`AND WHEN DID YOU DRAW THIS?
`A.
`JUNE 20TH, 1990.
`Q.
`WHY DID YOU HAVE TO ORDER MORE THAN ONE SIZE?
`A.
`IT WAS IMPOSSIBLE TO TELL THE EXACT SIZE THAT WOULD
`FIT BEST AT THE TIME OF SURGERY. WHAT WE DID WAS WE TRIED TO
`STRETCH THE ANNULUS, THE DISC, TO NORMAL HEIGHT AS HIGH AS WE
`COULD SO WE COULD HAVE A TIGHT FORCE FIT, AND IT WAS NEVER
`POSSIBLE TO TELL JUST HOW TIGHTLY OR HOW HIGH WE COULD SPREAD
`IT. SO PARTICULARLY, A VARIETY OF HEIGHTS WERE NEEDED.
`Q.
`WHO PAID FOR THESE IMPLANTS?
`A.
`WELL, THE HOSPITAL PAID FOR THEM, AND THEN EVENTUALLY
`THE PATIENT.
`Q.
`HOW DO YOU KNOW THAT?
`A.
`WELL, WE HAD DISCUSSIONS WITH THE FOOD AND DRUG
`ADMINISTRATION ALL DURING THAT TIME ABOUT THE TESTING
`PROCEDURES AND WHAT WAS ALLOWED AND WHAT WAS NOT ALLOWED AND
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`Case 3:08-cv-01512-CAB-MDD Document 391 Filed 09/20/11 PageID.18620 Page 132 of
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`08-CV-1512
`
`SURGERY WAS JULY 9TH OF 1990. THE SURGICAL INDICATION WAS A
`BURST FRACTURE AT L1. THIS IS A SIMPLIFIED THING FOR THE BASIC
`TABLE. HE HAD HIS BURST FRACTURE IN 1985. THE BURST FRACTURE
`HAD HEALED AND LEFT HIM WITH SEVERE DEGENERATIVE DISC DISEASE
`AT THE LEVEL ABOVE THE BURST FRACTURE AND BELOW. SO IT WAS T12
`AND L1, L1, L2. THE CAGE MATERIAL WAS MADE OF ULTRAPECK.
`THAT'S ONE OF THE POLYMERS THAT WE USED. VSP LEVELS, THAT'S AN
`ABBREVIATION FOR VARIABLE SCREW PLACEMENT OR THE PEDICLE
`SCREWS. HE HAD NO PEDICLE SCREWS USED. THE CAGE LEVELS WERE
`T12, L1, L1, L2. ETO, ETHYLENE OXIDE STERILIZED BONE, HE HAD
`NONE OF THAT. HIS SIX-MONTH OUTCOME WAS EXCELLENT. 12-AND
`24-MONTH OUTCOMES WERE EXCELLENT. CAGE FUSION, FIVE OUT OF
`FIVE WAS THE HIGHEST FUSION LEVEL, AND HE HAD NO
`REOPERATIONS.
`MR. MILLER: YOUR HONOR, I SEE THE CLOCK, AND THIS
`WOULD BE A GOOD POINT.
`THE COURT: ALL RIGHT. IT IS 4:30. SO LET'S TAKE
`OUR EVENING RECESS NOW. WE'LL RECONVENE, SAME TIME, SAME
`PLACE, AT 9:00 TOMORROW. HAVE A NICE EVENING. WE'LL SEE YOU
`BACK THEN.
`(EVENING ADJOURNMENT, 4:30 P.M.; TO RESUME SEPTEMBER 8, 2011,
`9:00 A.M.)
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`IPR2019-00362, Ex. 1056, p. 9 of 9
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`
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