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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE SOUTHERN DISTRICT OF CALIFORNIA
`
`HONORABLE MICHAEL M. ANELLO, DISTRICT JUDGE
`
`_____________________________
`)
`MEDTRONIC SOFAMOR DANEK, USA ) CASE NO. 08 CV 1512-MMA
`ET AL.,
`)
`)
`)
`)
`) DECEMBER 16, 2011
`)
`) FRIDAY, 9:00 AM
`)
`) BENCH TRIAL
`DEFENDANT.
`_____________________________) VOLUME 1
`
`PLAINTIFF,
`
`VS.
`
`NUVASIVE, INC.,
`
`
`
`
`
`REPORTER'S TRANSCRIPT OF PROCEEDINGS
`
`APPEARANCES:
`
`FOR THE PLAINTIFF:
`
`
`
`
`FOR THE DEFENDANT:
`
`
`
`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.
`TODD G. MILLER, ESQ.
`JONATHAN J. LAMBERSON, ESQ.
`NEIL WARREN, ESQ.
`KEELEY I. VEGA, ESQ.
`FISH & RICHARDSON, P.C.
`
`ELIZABETH CESENA, CSR 12266, (619) 237-0100
`USDC, SOUTHERN DISTRICT OF CA
`PO BOX 131037, SAN DIEGO, CA 92170
`
`WARSAW2056
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`Case IPR2013-00206
`
`Page 1
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`INDEX - 08CV1512, 12/16/11
`
`WITNESSES:
`
`DR. BRUCE VAN DAM
`
`DIRECT BY MR. SCHERKENBACH
`
`CROSS BY MR. DAUCHOT
`
`REDIRECT BY MR. SCHERKENBACH
`
`RECROSS BY MR. DAUCHOT
`
`RE-REDIRECT BY MR. SCHERKENBACH
`
`DR. BARTON LEWIS SACHS
`
`DIRECT BY MS. WICKRAMASEKERA
`
`AFTERNOON PROCEEDINGS
`
`DR. GARY KARLIN MICHELSON
`
`CROSS BY MR. SCHERKENBACH
`
`REDIRECT BY MR. DAUCHOT
`
`JAMES THOMAS CARMICHAEL
`
`
`
`DIRECT BY MR. MACKINNON
`
`CROSS BY MR. SCHERKENBACH
`
`REDIRECT BY MR. MACKINNON
`
`RECROSS BY MR. SCHERKENBACH
`
`PAGE:
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` 79
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` 96
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` 98
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`183
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`184
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`200
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`202
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`222
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`245
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`250
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`DR. BRUCE VAN DAM
`
`
`
`REBUTTAL BY MR. SCHERKENBACH
`
`252
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`
`
`
`
`
`
`ELIZABETH CESENA, CSR 12266, (619) 237-0100
`USDC, SOUTHERN DISTRICT OF CA
`PO BOX 131037, SAN DIEGO, CA 92170
`
`Page 2
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`WITH THE ANTEROLATERAL INCISION, THE BIG OPEN POSITION, PEEL
`
`BACK THE PSOAS MUSCLE AND THEN ENTER THE DISC SPACE
`
`COMPLETELY LATERAL. OKAY? THAT'S A FOR EXAMPLE AND THAT'S
`
`WHAT HE'S REFERRING TO. EXCUSE ME.
`
`Q
`
`SO HE WASN'T REFERRING TO APPROACHING -- AND WE'VE
`
`COVERED THAT. THAT'S FINE. MY ONLY POINT IS THIS. WHEN
`
`WE'RE TALKING ABOUT JUST BECAUSE YOU HAVE A PATIENT ON THE
`
`SIDE ON THE OPERATING TABLE AND YOU DECIDE TO CUT A PATIENT
`
`FROM THE SIDE, OKAY? DOESN'T MEAN THAT YOU'RE GOING TO BE
`
`PERFORMING A DIRECT LATERAL, AM I CORRECT?
`
`A
`
`WELL, YOU MIGHT END UP ANTEROLATERAL. IT JUST DEPENDS
`
`ON WHAT KIND OF ANATOMY YOU ARE TRYING TO APPROACH.
`
`Q
`
`THERE YOU GO. SO WHEN WE TALK ABOUT AND ANTEROLATERAL
`
`SO IN ANTEROLATERAL, I THINK THIS WAS YOUR TESTIMONY AT
`
`TRIAL IS BASICALLY --
`
`A
`
`YOU KNOW, YOU HAVE A MUCH BETTER MEMORY THAN I DO, BUT
`
`GO AHEAD.
`
`Q
`
`THAT'S ALL RIGHT. I'M YOUNGER. ANTEROLATERAL MEANS
`
`OBLIQUE TO THE CENTER?
`
`A
`
`WELL, TECHNICALLY ANTEROLATERAL WOULD MEAN ANY ANGLE
`
`OFF A DIRECT STRAIGHT MIDLINE 90-DEGREE APPROACH.
`
`Q
`
`SURE. BUT DURING TRIAL, WE WERE DISTINGUISHING BETWEEN
`
`THE ANTEROLATERAL AND THE DIRECT LATERAL?
`
`A
`
`CORRECT. THAT'S EXACTLY RIGHT. AS YOU ILLUSTRATE UP
`
`THERE, THAT'S CORRECT.
`
`ELIZABETH CESENA, CSR 12266, (619) 237-0100
`USDC, SOUTHERN DISTRICT OF CA
`PO BOX 131037, SAN DIEGO, CA 92170
`
`Page 3
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`Q
`
`SURE. AND WHAT YOU WERE SAYING IS WHEN YOU WERE
`
`CUTTING THE PATIENT OR PUTTING THE PATIENT ON THE SIDE AND
`
`YOU ARE MAKING A LATERAL INCISION, OKAY? THE AIM VERY WELL
`
`COULD BE APPROACHING IT ANTERO LATERALLY AS OPPOSED TO
`
`DIRECT LATERAL?
`
`A
`
`FAIR POINT. AND COULD BE, IF I JUST BE SPECIFIC, AIM
`
`COULD BE TO INSERT THE IMPLANT ANTEROLATERAL OR DIRECT
`
`LATERAL.
`
`Q
`
`OKAY. WE'RE ON THE SAME PAGE. SO CAN WE TURN TO DX
`
`5885? PAGE EIGHT. CAN YOU BLOW UP FOR ME, DAVID, ON THE
`
`SECOND COLUMN, THE PARAGRAPH ENTITLED "POSITIONING".
`
`OKAY. NOW IT STATES IN THE SECOND SENTENCE OR
`
`FIRST SENTENCE, FOR APPROACHES TO THE LOWER THREE LUMBAR
`
`INTERVERTEBRAL DISCS, PATIENTS ARE PLACED SUPINE ON THE
`
`OPERATING TABLE, RIGHT?
`
`A
`
`Q
`
`THAT'S WHAT IT SAYS.
`
`AND YOU'VE TESTIFIED THAT LOWER THREE LUMBAR
`
`INTERVERTEBRAL DISCS MEANS TO YOU, THE L FOUR, L FIVE AND
`
`THE L FIVE S-1?
`
`A
`
`WELL, HE IS SAYING THE LOWER THREE LUMBER DISCS. THE
`
`LOWER THREE LUMBAR DISCS ARE NOT ONLY TO ME BUT EVERYBODY
`
`ELSE HOPEFULLY, L3-4, L4-5 AND L5 S1.
`
`Q
`
`A
`
`Q
`
`THAT'S WHAT I JUST SAID.
`
`NO. I THINK YOU SAID L FOUR AND L5 S-1.
`
`BUT YOU CONSIDER L3 AND L4 TO BE UPPER?
`
`ELIZABETH CESENA, CSR 12266, (619) 237-0100
`USDC, SOUTHERN DISTRICT OF CA
`PO BOX 131037, SAN DIEGO, CA 92170
`
`Page 4
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`Q
`
`OKAY. NOW CAN WE GO BACK TO DX 5885, PAGE EIGHT? THE
`
`POSITIONING PART.
`
`NOW ON THE SECOND SENTENCE HE STATES, FOR RARE
`
`UPPER LUMBAR FUSIONS, THEY, THEY BEING THE PATIENTS, ARE
`
`PLACED IN THE LATERAL POSITION WITH THE LEFT LOIN UPPERMOST.
`
`RIGHT?
`
`A
`
`Q
`
`YES.
`
`OKAY. NOW GIVEN YOUR PRIOR TESTIMONY, THAT STATEMENT
`
`DOES NOT TELL YOU HOW THE IMPLANT IS IMPLANTED IN THE
`
`VERTEBRAL SPACE, CORRECT?
`
`A
`
`CORRECT. IT WOULDN'T TELL YOU EXACTLY HOW THE IMPLANT
`
`IS PLACED IN THE DISC SPACE BUT IT CERTAINLY GIVING YOU THE
`
`ORIENTATION OF THE PATIENT, YES, FOR THE APPROACH, FOR THE
`
`ACCESS.
`
`Q
`
`ACCORDING TO YOUR PRIOR TESTIMONY, THAT STATEMENT IS
`
`COMPLETELY CONSISTENT WITH THE INSERTION OF AN IMPLANT FROM
`
`ANTEROLATERAL SO JUST OFF THE MIDLINE OF THE FRONT OF THE
`
`DISC SPACE. THAT WAS YOUR TESTIMONY HERE, CORRECT.
`
`A
`
`YES. AND I WOULD JUST AGAIN TO BE PRECISE, THE
`
`APPROACH TO THE LUMBAR SPINE WITH A PATIENT IN A LATERAL
`
`DECUBITUS OR A SIDE POSITION, WOULD PERMIT YOU TO, ACTUALLY
`
`YOU CAN GO STRAIGHT ANTERIORLY BUT NOT VERY CONVENIENTLY,
`
`WOULD PERMIT YOU FAIRLY CONVENIENTLY TO PUT AN IMPLANT IN
`
`ANTERO LATERALLY OR IF YOU PEEL BACK THE PSOAS MUSCLE
`
`DIRECTLY LATERALLY.
`
`ELIZABETH CESENA, CSR 12266, (619) 237-0100
`USDC, SOUTHERN DISTRICT OF CA
`PO BOX 131037, SAN DIEGO, CA 92170
`
`Page 5
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`EXPLANATIONS AS YOU COULD AS TO WHY CROCK TAUGHT A LATERAL
`
`APPROACH, IS THAT FAIR TO SAY?
`
`A
`
`Q
`
`I DID.
`
`AND YOU STUDIED IT. YOU SPENT A LOT OF TIME THINKING
`
`ABOUT IT?
`
`A
`
`Q
`
`A
`
`I DID THINK ABOUT IT, YES.
`
`BUT YOU DIDN'T THINK ABOUT THIS, AT THAT POINT?
`
`WELL THERE'S CERTAIN THINGS THAT HAVE COME UP SINCE THE
`
`TRIAL IN SEPTEMBER THAT SEEM TO REQUIRE EMPHASIS THAT DIDN'T
`
`APPEAR TO REQUIRE EMPHASIS EARLIER, SO.
`
`Q
`
`FAIR ENOUGH. NOW DR. CROCK DOES SAY THAT, I THINK THIS
`
`WAS YOUR TESTIMONY AT TRIAL, THAT HE WAS -- YOUR TESTIMONY
`
`AT TRIAL, YOUR INTERPRETATION OF CROCK, DR. CROCK'S ARTICLE
`
`HERE WAS THAT HE TAUGHT A LATERAL APPROACH FOR UPPER LUMBAR
`
`PROCEDURES. THAT WAS YOUR TESTIMONY AT TRIAL.
`
`DO YOU REMEMBER THAT?
`
`A
`
`I BELIEVE THAT'S CORRECT. THAT'S WHAT I WOULD SAY
`
`TODAY, YES.
`
`Q
`
`A
`
`Q
`
`L 4, L 5 IS NOT UPPER LUMBAR?
`
`IT'S NOT.
`
`OKAY. AND PARTICULARLY, AT THAT POINT IN TIME, FAIR TO
`
`SAY THAT ACCESSING L FOUR, L FIVE AT THAT POINT IN TIME WAS
`
`A TRICKY THING IN PART BECAUSE YOU WERE ALSO DEALING WITH
`
`THE PELVIC BONE? THAT MADE IT MORE DIFFICULT THAN THE UPPER
`
`LUMBAR?
`
`ELIZABETH CESENA, CSR 12266, (619) 237-0100
`USDC, SOUTHERN DISTRICT OF CA
`PO BOX 131037, SAN DIEGO, CA 92170
`
`Page 6
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`A
`
`WELL THE ILIAC CREST IN 2011 CAN PRESENT A CHALLENGE AT
`
`L FOUR FIVE.
`
`Q
`
`OKAY. NOW WHEN WE'RE TALKING ABOUT SPONDYLOLISTHESIS,
`
`DO I HAVE THAT RIGHT?
`
`A
`
`Q
`
`A
`
`Q
`
`NO.
`
`NO. OKAY. BUT THAT'S A PRETTY GOOD TRY.
`
`OKAY.
`
`WE ARE BASICALLY TALKING, LET ME TRY TO DO THIS FROM
`
`THE LATERAL RESPECT. TRY IT AGAIN. WE ARE TALKING ABOUT
`
`YOU HAVE GOT A TOP VERTEBRAL BODY AND YOU HAVE A BOTTOM
`
`VERTEBRAL BODY AND THEY SLIP LIKE THAT, RIGHT?
`
`A
`
`Q
`
`THAT'S RIGHT.
`
`AND HE'S TRYING TO ADDRESS THE PROBLEM AND FUSE THESE
`
`TWO TOGETHER, CORRECT?
`
`A
`
`Q
`
`YES.
`
`AND WHAT HE NOTES IS THAT THERE ARE TWO, WELL AT LEAST
`
`TWO, INNER BODY GRAPH, PLURAL, THAT HAVE BEEN INSERTED
`
`TRANSVERSELY, RIGHT?
`
`A
`
`Q
`
`YES.
`
`AND IS IT YOUR TESTIMONY HERE THAT WHEN YOU ARE DEALING
`
`WITH THESE DISCS, LIKE THAT, THAT HE STUCK, THAT HE ACTUALLY
`
`STUCK TWO BONE DOWELS, SO CUT, HE CUT HERE AND HE CUT HERE
`
`AND IN THIS LIMITED SPACE FROM A DIRECT LATERAL APPROACH HE
`
`MANAGED TO SHOVE TWO PIECES OF BONE IN THERE.
`
`IS THAT YOUR TESTIMONY?
`
`ELIZABETH CESENA, CSR 12266, (619) 237-0100
`USDC, SOUTHERN DISTRICT OF CA
`PO BOX 131037, SAN DIEGO, CA 92170
`
`Page 7
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`BY MR. DAUCHOT:
`
`Q
`
`DAVID, CAN YOU PUT UP THE CROCK ARTICLE IF YOU WOULD,
`
`DX 5885, AND CAN YOU GO TO FIGURE SEVEN A.
`
`DO YOU MIND IF I USE YOUR POINTER?
`
`A
`
`Q
`
`YOU CAN BORROW IT. SURE.
`
`DOCTOR, WE'RE LOOKING AT SEVEN A OF THE CROCK ARTICLE
`
`AND DO YOU SEE THE SHADOW HERE, YOU SEE HOW IT'S LIGHTER UP
`
`HERE AND DARKER DOWN HERE. YOU SEE HOW THERE'S AN OUTLINE?
`
`A
`
`Q
`
`A
`
`Q
`
`YES. I SEE THE ILIAC CREST.
`
`THAT'S THE ILIAC CREST?
`
`SURE.
`
`RIGHT. AND THE AREA THAT'S BEING WORKED ON IS IT NEAR
`
`THE ILIAC CREST?
`
`A
`
`Q
`
`YES.
`
`IF YOU ARE GOING TO APPROACH IT DIRECT LATERAL, HOW ARE
`
`YOU GOING TO GET THROUGH THE ILIAC CREST TO GET AT THIS
`
`SPACE?
`
`A
`
`YOU'RE GOING TO PUT THE PERSON ON THE SIDE OR FLEX THE
`
`TABLE TO GET THE ILIAC CREST OUT OF THE WAY.
`
`Q
`
`FLEX THE TABLE, NOW THESE SPECIAL TABLES, I KNOW I'VE
`
`SEEN THIS IN NUVASIVE LITERATURE.
`
`A
`
`Q
`
`REQUIRES A SPECIAL TABLE.
`
`IS THERE ANY REFERENCE IN THE CROCK ARTICLE ABOUT
`
`HAVING TO ESPECIALLY CONTOUR THE PATIENT TO GET AT L FOUR L
`
`FIVE, WITH THE ILIAC CREST IN THE WAY? IS THERE ANYTHING IN
`
`ELIZABETH CESENA, CSR 12266, (619) 237-0100
`USDC, SOUTHERN DISTRICT OF CA
`PO BOX 131037, SAN DIEGO, CA 92170
`
`Page 8
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`THE ARTICLE ABOUT THAT IN THIS SURGICAL TECHNIQUE?
`
`A
`
`THERE ISN'T. AND THERE ISN'T ANY MENTION ABOUT WASH
`
`YOUR HANDS BEFORE SURGERY EITHER.
`
`Q
`
`NO. BUT THERE IS A -- WELL, STRIKE THE QUESTION. I
`
`JUST DO WANT TO, I KNOW YOU'RE BEING FLIP --
`
`A
`
`Q
`
`WELL, I'M BEING FLIP BECAUSE IT'S KIND OF A --
`
`DOCTOR, CAN I FINISH THE QUESTION. I KNOW YOU'RE BEING
`
`FLIP?
`
`A
`
`Q
`
`UH-HUH.
`
`BUT WE ALL AGREE THAT ESPECIALLY POSITIONING A PATIENT
`
`TO ENABLED SOMEONE TO GET AT THE L 4- L FIVE FROM A DIRECT
`
`LATERAL POSITION GIVEN THE FACT THAT THE ILIAC CREST IS IN
`
`THE WAY IS AN IMPORTANT PART OF A TECHNIQUE?
`
`A
`
`Q
`
`A
`
`IT IS.
`
`WOULD YOU AGREE WITH THAT?
`
`WELL, I WOULD AGREE WITH YOU THAT YOU DO HAVE TO TAKE
`
`INTO ACCOUNT THE ILIAC CREST AND WHEN YOU HAVE THE PERSON ON
`
`THEIR SIDE, YOU DO HAVE TO FLEX THE TABLE.
`
`Q
`
`IS THERE ANY REFERENCE ABOUT ANY OF THAT IN THE
`
`ARTICLE?
`
`A
`
`Q
`
`A
`
`THERE IS NOT A SPECIFIC REFERENCE.
`
`IS THERE A GENERAL REFERENCE?
`
`THERE IS NO REFERENCE THAT I KNOW OF IN THAT ARTICLE
`
`THAT SPECIFICALLY SPEAKS TO THAT ISSUE OF ILIAC CREST AND
`
`RELATIVE TO THE L FOUR FIVE DISC.
`
`ELIZABETH CESENA, CSR 12266, (619) 237-0100
`USDC, SOUTHERN DISTRICT OF CA
`PO BOX 131037, SAN DIEGO, CA 92170
`
`Page 9