`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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`0001
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`NUVASIVE - EXHIBIT 2060
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00361
`
`
`
`08-CV-1512
`
`SORRY I HAVEN'T MET YOU BEFORE. I JUST WANT TO THANK YOU FOR
`HELPING BRING LATERAL ACCESS SURGERY TO THE SPINAL SURGERY
`INDUSTRY, THAT THE THINGS YOU'VE BEEN ABLE TO DO HAVE BEEN
`REALLY QUITE DRAMATIC AND HELPFUL TO ALL OF US." THEN HE
`COMPLIMENTED ME ON WHAT SOLAS HAS DONE, THE SOCIETY OF LATERAL
`ACCESS SURGERY. I DON'T KNOW IF YOU ALL HAVE HEARD ANYTHING
`ABOUT THAT, AND HIS COMMENT TO ME WAS WE WANTED TO DO SOMETHING
`SIMILAR WITH MEDTRONICS, AND HE WANTED TO HAVE MY INPUT WITH
`THAT.
`Q.
`
`THANK YOU. NO FURTHER QUESTIONS.
`THE COURT: ANY RECROSS?
`MR. DAUCHOT: NO, YOUR HONOR.
`THE COURT: ALL RIGHT. THANK YOU, SIR. YOU MAY STEP
`
`DOWN.
`
`BRANTIGAN:
`
`NEXT WITNESS FOR NUVASIVE.
`MR. MILLER: YOUR HONOR, NUVASIVE CALLS DR. JOHN
`
`THE COURT: ALL RIGHT.
`COME ON UP FRONT HERE, SIR. WHEN YOU GET UP HERE,
`RAISE YOUR RIGHT HAND, AND WE'LL SWEAR YOU IN.
`THE CLERK: DO YOU SOLEMNLY SWEAR THE TESTIMONY YOU
`SHALL GIVE IN THE CAUSE NOW BEFORE THIS COURT SHALL BE THE
`TRUTH, THE WHOLE TRUTH AND NOTHING BUT THE TRUTH, SO HELP YOU
`GOD?
`
`THE WITNESS: I DO.
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`1442
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`08-CV-1512
`
`THE CLERK: PLEASE TAKE THE WITNESS STAND. STATE
`YOUR FULL NAME FOR THE RECORD AND SPELL IT PLEASE.
`THE WITNESS: JOHN W. BRANTIGAN, B-R-A-N-T-I-G-A-N.
`DIRECT EXAMINATION
`
`BY MR. MILLER:
`Q.
`GOOD AFTERNOON, DR. BRANTIGAN.
`A.
`GOOD AFTERNOON.
`Q.
`WHAT IS YOUR OCCUPATION?
`A.
`I WAS A ORTHOPEDIC SPINAL SURGEON. I'M NOW
`RETIRED.
`ARE YOU HERE TODAY TO TALK ABOUT THE BRANTIGAN
`Q.
`IMPLANTS AND HOW YOU CAME TO DEVELOP AND INVENT THOSE
`IMPLANTS?
`A.
`YES, I AM.
`Q.
`COULD YOU PLEASE BRING UP DX5118?
`WHAT DO WE SEE HERE, DOCTOR?
`THAT'S A PHOTOGRAPH OF THREE OF THE IMPLANTS OF MY
`A.
`OVAL CAGE DESIGN. THOSE ARE THE COMMON, SMALL, MEDIUM AND
`LARGE SIZES.
`Q.
`YOU TOLD US YOU'RE A RETIRED ORTHOPEDIC SURGEON.
`WHEN DID YOU STOP PERFORMING SURGERY?
`A.
`2004.
`Q.
`HOW MANY YEARS DID YOU CARE FOR SURGICAL PATIENTS?
`A.
`WELL, STARTING WITH MY INTERNSHIP IN 1970, STOPPING
`IN 2004. THAT'S 34 YEARS.
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`0003
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`08-CV-1512
`
`OVER THE COURSE OF YOUR CAREER, HOW MANY SPINE
`Q.
`SURGERIES DID YOU DO?
`A.
`WELL OVER 3,000.
`Q.
`WHY DID YOU STOP PERFORMING SURGERY?
`A.
`MY CAREER WAS A LITTLE DIFFERENT FROM SOME SURGEONS
`IN THAT I WAS DEVELOPING THESE IMPLANTS FOR SPINE SURGERY. IN
`2004, I WAS DOING A CLINICAL PRACTICE, BUT I WAS DOING A LOT OF
`TEACHING, AND I FELT THAT IT WAS MORE IMPORTANT TO WORK AND
`DESCRIBE THE TECHNIQUE AND THE OUTCOMES WITH THIS VARIETY OF
`IMPLANTS FOR SPINAL SURGERY. SO I SPENT MY TIME DOING
`WRITING.
`AND DID YOU END UP WRITING A BOOK?
`Q.
`YES, I DID.
`A.
`IS DX5153 INTERVERTEBRAL FUSION USING CARBON FIBER
`Q.
`REINFORCED POLYMER IMPLANTS YOUR BOOK?
`A.
`YES, IT IS.
`Q.
`WHEN WAS YOUR BOOK PUBLISHED?
`A.
`2006.
`Q.
`DID OTHER SURGEONS CONTRIBUTE TO THE WRITING OF THIS
`BOOK?
`YES, THEY DID.
`A.
`WHO WERE THEY?
`Q.
`I RECRUITED AS MY CO-EDITOR DR. CARL LAURYSSEN. I
`A.
`COME FROM AN ORTHOPEDIC SPINE BACKGROUND. CARL COMES FROM A
`NEURO SURGICAL SPINE BACKGROUND. SO HIS PERSPECTIVE WAS VERY
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`08-CV-1512
`
`IMPORTANT. I ALSO HAD 50 CO-AUTHORS, MOST OF THEM FROM ALL
`AROUND THE WORLD, WHO HAD EXTENSIVE EXPERIENCE, AND THEY WROTE
`CHAPTERS SHARING THEIR EXPERIENCE WITH THESE IMPLANTS.
`Q.
`ARE YOUR IMPLANTS -- ARE THE IMPLANTS THAT YOU
`DEVELOPED AND INVENTED, THE ONES THAT WE SAW PREVIOUSLY, THE
`OVAL CAGES, ARE THEY STILL SOLD TODAY?
`A.
`YES, THEY ARE.
`Q.
`WHO SELLS THEM?
`A.
`DEPUY SPINE.
`Q.
`IS THAT PART OF JOHNSON AND JOHNSON?
`A.
`YES.
`Q.
`HOW MANY PATIENTS HAVE HAD SURGERIES USING YOUR OVAL
`IMPLANT?
`WELL OVER 100,000.
`A.
`I'D LIKE TO TALK ABOUT YOUR SURGICAL EDUCATION AND
`Q.
`EXPERIENCE AS A SURGEON IN THE 1970S AND EARLY '80S THAT LED
`YOU TO DEVELOP THOSE OVAL IMPLANTS. LET'S START WITH WHERE DID
`YOU GRADUATE FROM MEDICAL SCHOOL?
`A.
`I GRADUATED FROM JOHNS HOPKINS UNIVERSITY IN 1970.
`Q.
`AFTER GETTING YOUR M.D. DEGREE, WHERE DID YOU GET
`YOUR FIRST SURGICAL TRAINING?
`A.
`I DID A SURGICAL INTERNSHIP AT THE UNIVERSITY OF
`MINNESOTA AND MINNEAPOLIS.
`Q.
`WHY THE UNIVERSITY OF MINNESOTA?
`A.
`THEY HAD A WORLD-FAMOUS SURGERY TRAINING PROGRAM THAT
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`08-CV-1512
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`WAS RECOMMENDED TO ME BY MY MENTOR AT JOHNS HOPKINS, AND ALSO,
`THEY HAD A TOP-NOTCH ORTHOPEDIC AND SPINE TRAINING PROGRAM.
`Q.
`WHEN DID YOU FINISH YOUR INTERNSHIP?
`A.
`1971.
`Q.
`WHAT DID YOU DO AFTER YOU COMPLETED THAT
`INTERNSHIP?
`A.
`I VOLUNTEERED FOR MILITARY SERVICE IN THE UNITED
`STATES AIR FORCE.
`Q.
`AFTER YOU COMPLETED YOUR MILITARY SERVICE, WHAT DID
`YOU DO?
`I WENT BACK INTO SURGICAL TRAINING SPENDING ONE YEAR
`A.
`OF GENERAL SURGERY TRAINING AT THE UNIVERSITY OF UTAH, AND THEN
`I ATTENDED THE ORTHOPEDIC SURGERY RESIDENCY PROGRAM AT THE
`UNIVERSITY OF WASHINGTON IN SEATTLE FROM 1974 THROUGH 1978.
`Q.
`DID YOU THEN GO INTO PRIVATE PRACTICE?
`A.
`YES, I DID.
`Q.
`WHERE?
`A.
`OMAHA, NEBRASKA.
`Q.
`WHY OMAHA?
`A.
`AT THAT TIME THERE WAS A RELATIVE SHORTAGE OF
`ORTHOPEDIC SURGEONS IN NEBRASKA, AND IN THE MID-WEST GENERALLY,
`AND JUST HAVING TRAINED IN SURGERY, I WANTED TO HAVE AN
`OPPORTUNITY TO HAVE EXTENSIVE SURGICAL EXPERIENCE. SO I
`THOUGHT MY OPPORTUNITIES FOR EXPERIENCE WOULD BE GREATER IN A
`PLACE LIKE NEBRASKA.
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`
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`08-CV-1512
`
`WHAT TYPE OF SURGERY DID YOU DO IN YOUR FIRST YEAR OF
`Q.
`PRACTICE?
`A.
`I JOINED A GROUP. HALF OF THEIR PRACTICE WAS GENERAL
`ORTHOPEDICS, DOING HIPS AND KNEE AND SO FORTH, AND HALF OF IT
`WAS TOTALLY IN SPINE SURGERY.
`Q.
`AND WHAT TYPE OF SPINE SURGERY DID YOU DO DURING THAT
`YEAR?
`ONE OF THE PEOPLE I WORKED WITH WAS DR. DAVID
`A.
`KETTLESON WHO DID ALL OF THE SCOLIOSIS SURGERIES IN NEBRASKA.
`Q.
`HOW MANY SCOLIOSIS SURGERIES DID YOU DO IN THAT
`YEAR?
`I WORKED WITH DR. KETTLESON DOING OVER ONE HUNDRED
`A.
`SCOLIOSIS SURGERIES DURING THAT ONE YEAR.
`Q.
`CAN YOU TELL US WHAT SCOLIOSIS IS AND HOW IT'S
`TREATED SURGICALLY?
`A.
`SCOLIOSIS IS CURVATURE OF THE SPINE, PARTICULARLY IN
`ADOLESCENT PATIENTS. THE SURGERY TO CORRECT THAT BASICALLY
`PRODUCES MANUAL STRAIGHTENING OF THE CURVE AND HOLDING THAT
`CORRECTION WITH RODS AND SCREWS, HOOKS, VARIOUS IMPLANTS, AND
`THE CORRECTION IS HELD PERMANENTLY WITH A FUSION PROCEDURE
`WHEREBY THE BONES ARE ENTICED TO GROW TOGETHER USING BONE
`GRAFT.
`Q.
`SURGERY?
`A.
`
`AT THAT TIME, THE HARRINGTON ROD INSTRUMENTATIONS
`
`HOW DO YOU STABILIZE THE PATIENT AFTER THAT
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`08-CV-1512
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`WERE RELATIVELY UNSTABLE, AND THAT REQUIRED US TO PLACE THE
`PATIENTS IN BODY CASTS FOR PERIOD OF NINE MONTHS.
`Q.
`WHAT DID YOU DO AFTER YOUR FIRST YEAR IN PRACTICE?
`A.
`THEN I OPENED MY SOLO ORTHOPEDIC PRACTICE IN
`NEBRASKA.
`Q.
`DID YOU CONTINUE TO DO SPINE SURGERY?
`A.
`YES, I DID.
`Q.
`AND HOW OFTEN DID YOU USE SPINE FUSION SURGERY TO
`TREAT PATIENTS WITH BACK PAIN?
`A.
`SELDOM.
`Q.
`WHY IS THAT?
`A.
`BECAUSE THE STATISTICAL RESULTS WERE NOT VERY GOOD.
`Q.
`COULD YOU DESCRIBE WHAT THE PATIENT EXPERIENCE WAS
`LIKE IN THE LATE '70S, EARLY '80S, FOR PATIENTS WHO UNDERWENT
`SPINE FUSION SURGERY TO TREAT THEIR BACK PAIN?
`MR. DAUCHOT: YOUR HONOR, IF I CAN JUST MAKE AN
`OBJECTION. AGAIN, HE'S A FACT WITNESS, AND IF IT'S PERSONAL
`EXPERIENCE, THAT'S FINE. I JUST WANT TO MAKE SURE WE DRAW THE
`SAME LINE.
`THE COURT: I THINK THIS IS THE SAME TENSION WE HAD
`BEFORE. HE'S HERE AS A FACT WITNESS. ALTHOUGH, I'M CERTAIN
`HE'S AN EXPERT, BUT HE'S HERE IN A FACT WITNESS CAPABILITY. SO
`WE'RE GOING TO TRY TO LIMIT IT TO HIS OWN PERSONAL EXPERIENCE
`AND NOT OPINIONS.
`///
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`08-CV-1512
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`BY MR. MILLER:
`Q.
`SO, DOCTOR, I'M SEEKING YOUR PERSONAL EXPERIENCE AS A
`SURGEON IN THE 1970S AND '80S.
`A.
`WELL, IN MY PERSONAL EXPERIENCE, DAVE KETTLESON, WHO
`WAS THE BEST SPINE SURGEON IN NEBRASKA, NEVER WOULD DO FUSION
`FOR DEGENERATIVE DISC DISEASE. I SELDOM DID EITHER BECAUSE
`WHEN WE DID, THE TYPICAL PATIENT WAS IN AGONY AFTER SURGERY.
`WE WOULD TYPICALLY GET THREE OR FOUR TELEPHONE CALLS AT NIGHT
`BECAUSE OF THE PATIENT'S PAIN. WE GAVE THEM LARGE DOSES OF
`NARCOTICS WHICH CAUSED COMPLICATIONS. THEY WOULD HAVE
`DIFFICULTY BREATHING, DEVELOP PNEUMONIA, URINARY RETENTION,
`DIFFICULTLY WITH BOWEL AND BLADDER. THEY WERE IN THE HOSPITAL
`FOR THREE WEEKS. IT WAS VERY PAINFUL EXPERIENCE FOR THE
`PATIENT.
`AND IN YOUR EXPERIENCE, DID THE PATIENTS HAVE TO HAVE
`Q.
`SUBSEQUENT SURGERIES?
`A.
`IT FREQUENTLY FAILED TO GAIN RELIEF FOR THE PATIENTS.
`THEY HAD SUBSEQUENT SURGERIES TO FIX THE FAILURE OF THE
`FUSION.
`AND IF THE FUSION WASN'T A GOOD TREATMENT OPTION --
`Q.
`AND IT DOESN'T SOUND TERRIBLY GOOD -- WHAT WAS DONE FOR BACK
`PAIN PATIENTS WHO DIDN'T GO WITH SURGERY?
`A.
`WELL, WE USED BRACES. WE DID VARIETY OF MEDICATIONS.
`WE HAD PHYSICAL THERAPY, CHIROPRACTIC TREATMENTS. ALL OF THOSE
`HAD SOME ROLE FOR BACK PAIN PATIENTS, BUT FOR PEOPLE REALLY
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`08-CV-1512
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`DISABLED BY BACK PAIN, IT REALLY DIDN'T HELP.
`Q.
`WAS THAT FRUSTRATING FOR YOU?
`A.
`OF COURSE IT WAS FRUSTRATING TO HAVE PATIENTS THAT
`YOU COULD NOT HAVE A SATISFACTORY SOLUTION FOR.
`Q.
`WHAT DID YOU DO IN RESPONSE?
`A.
`WELL, I TRIED TO FIND WAYS OF IMPROVING THIS KIND OF
`TREATMENT.
`Q.
`HOW DID YOU THINK YOU WOULD IMPROVE THAT TREATMENT?
`A.
`WELL, AT THAT TIME, MY BACKGROUND, I WAS INVOLVED IN
`GENERAL ORTHOPEDIC SURGERY AS WELL. I WAS ONE OF THE ORIGINAL
`INVESTIGATORS FOR THE NEW JERSEY TOTAL KNEE REPLACEMENT. THAT
`WAS ONE OF THE FIRST SYSTEMS THAT HAD A POROUS BONE INGROWTH
`SURFACE BY WHICH THE BONE COULD GROW INTO THE IMPLANT AND
`PROVIDE BIOLOGIC FIXATION; AND BASED ON THAT EXPERIENCE, I
`THOUGHT WE COULD USE A DOWEL OF THE SAME MATERIAL TO PROVIDE A
`MECHANICAL FIXATION IN THE SPINE AND PERHAPS GET A BETTER
`STATISTICAL QUALITY RESULTS.
`Q.
`WHAT TIME FRAME WAS THIS?
`A.
`ABOUT 1982.
`Q.
`WHY DID YOU THINK PUTTING A METAL DOWEL IN THE PINE
`WOULD BE A GOOD IDEA?
`A.
`WELL, THAT GOT BACK TO WORK BY DR. CLOWARD WHO
`DEVELOPED A PROCEDURE CALLED THE POSTERIOR LUMBAR INTERBODY
`FUSION OR PLIF. IN DR. CLOWARD'S PROCEDURE, HE USED
`RECTANGULAR BLOCKS OF BONE, FOUR OR FIVE OF THEM IN A ROW IN A
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`08-CV-1512
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`DISC SPACE, AND WHEN THAT STABILIZED THE SPINE MECHANICALLY AND
`GREW IN, IT PROVIDED RELIEF. UNFORTUNATELY, STATISTICALLY
`FREQUENTLY THAT BONE CRUMBLED AND THE PATIENTS WERE LEFT IN
`PAIN. SO MY THOUGHT WAS IF WE PRODUCED A METAL IMPLANT WITH A
`POROUS SURFACE, IT WAS MECHANICALLY STRONGER AND THAT IT WOULD
`NOT CRUMBLE AND THEREFORE POSSIBLY COULD GIVE STATISTICALLY
`BETTER RESULTS.
`Q.
`IN 1983, WAS ANYBODY SELLING, TO YOUR KNOWLEDGE, AN
`ARTIFICIAL SPINE FUSION IMPLANT?
`A.
`NO, THEY WERE NOT.
`Q.
`DID YOU TELL ANYONE ABOUT YOUR IDEA FOR AN ARTIFICIAL
`SPINE FUSION IMPLANT?
`A.
`YES, I DID.
`Q.
`WHO WAS THAT?
`A.
`I TOLD DR. VERT MOONEY. THIS WAS ABOUT 1983 AT THE
`NEW ORLEANS MEETING OF THE AMERICAN ACADEMY OF ORTHOPEDIC
`SURGEONS.
`Q.
`WHAT WAS DR. MOONEY'S RESPONSE?
`MR. DAUCHOT: OBJECTION, YOUR HONOR. TWO POINTS,
`HEARSAY AND RELEVANCE AS WELL.
`THE COURT: SUSTAINED.
`BY MR. MILLER:
`Q.
`DID DR. MOONEY PROVIDE YOU ENCOURAGEMENT?
`A.
`YES, HE DID.
`MR. DAUCHOT: OBJECTION, YOUR HONOR. THAT'S LEADING.
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`08-CV-1512
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`GETTING AROUND HEARSAY.
`THE COURT: I THINK IT IS BOTH. SUSTAINED.
`MR. DAUCHOT: AND I ASK THAT HIS ANSWER BE
`STRICKEN.
`THE COURT: I'LL ASK THE JURY TO DISREGARD THAT LAST
`ANSWER. GO AHEAD.
`BY MR. MILLER:
`Q.
`WHAT DID YOU DO NEXT?
`A.
`WELL, AT THAT TIME, I LOOKED INTO THE ALTERNATIVES,
`AND OTHER PEOPLE WERE USING PEDICLE SCREWS TO TREAT
`DEGENERATIVE CONDITIONS OF THE SPINE. AS I LOOKED INTO IT,
`DR. ART STEFFEE HAD STARTED A COMPANY CALLED ACROMED, AND
`DR. STEFFEE WAS PROVIDING THREE-DAY COURSES THAT TEACH SURGEONS
`HOW TO USE THESE PEDICLE SCREWS.
`Q.
`DID YOU ATTEND ONE OF THESE PRESENTATIONS?
`A.
`YES, I DID.
`Q.
`DID YOU SHOW YOUR IMPLANT DESIGN TO DR. STEFFEE?
`A.
`YES, I DID.
`Q.
`DID HE BECOME INVOLVED AT ALL WITH THIS IMPLANT?
`A.
`WELL, DR. STEFFEE DIDN'T LIKE THE ORIGINAL ITERATION.
`HE THOUGHT THAT THESE METAL PLUGS --
`MR. DAUCHOT: YOUR HONOR, OBJECTION. HEARSAY.
`THE COURT: YEAH. WE GOT SOME WEIRD RULES OF
`EVIDENCE WE GOT TO DEAL WITH HERE. I THINK WE CAN GET TO THE
`SAME PLACE WITHOUT HAVING HIM TELL WHAT SOMEONE ELSE SAID.
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`08-CV-1512
`
`THERE MAY BE OBJECTIONS, AND WE CAN GO THROUGH THAT; BUT IT'S
`USUALLY EASIER TO GET AROUND IT BY FRAMING THE QUESTION. SO
`LET'S TRY IT.
`BY MR. MILLER:
`Q.
`SO DOCTOR, DID YOU END UP PARTNERING WITH
`DR. STEFFEE WITH REGARD TO THIS FIRST GENERATION OF YOUR
`IMPLANT?
`NO.
`A.
`WHAT DID YOU DO NEXT?
`Q.
`WELL, I REALIZED THAT PERHAPS THESE COULD BE
`A.
`IMPROVED, AND I CHANGED MY MATERIAL FROM METAL TO A CARBON
`FIBER POLYMER, BASICALLY A PLASTIC MATERIAL.
`Q.
`WHY DID YOU THINK OF CARBON FIBER POLYMER?
`A.
`CARBON FIBER HAS SEVERAL ADVANTAGES. ONE IS IT'S
`FLEXIBLE. SO THE METAL IS TEN TIMES TOO STIFF. IT'S
`RADIOLUSCENT. SO IT DOESN'T BLOCK X-RAYS. YOU CAN SEE THE
`HEALING OF BONE, AND CARBON HAS A NATURAL BONE IN-GROWTH
`PROPERTY THAT WOULD MAKE IT FAVORABLE FOR FUSION.
`(TELEPHONE INTERRUPTION IN THE PROCEEDINGS.)
`THE COURT: WELL, WE'RE GOING TO HAVE TO PUT SOMEONE
`IN JAIL. WHERE'S THE BAILIFF?
`BY MR. MILLER:
`Q.
`WHERE DID YOU GET THE IDEA TO USE CARBON FIBER
`POLYMER?
`A.
`
`THE FIRST USE OF CARBON FIBER IN THE SPINE -- I'M
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`08-CV-1512
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`SORRY, IN THE BODY -- WAS DR. VINCENT GOTT WHO I WORKED WITH A
`JOHNS HOPKINS. HE WAS USING CARBON FOR VARIOUS STENTS IN THE
`HEART. SO I WAS FOLLOWING CARBON ON THAT EXPERIENCE.
`MR. MILLER: CAN WE HAVE DX5904, PLEASE?
`BY MR. MILLER:
`Q.
`DOCTOR, IS THIS IMPLANT ON THE COVER OF YOUR 757
`PATENT? IS THIS ONE OF YOUR FIRST CARBON FIBER IMPLANTS?
`A.
`YES, IT IS.
`Q.
`WHEN DID YOU START WORKING ON CARBON FIBER POLYMER
`FOR IMPLANTS?
`A.
`ABOUT 1987.
`Q.
`WHY DID YOU LEAVE THAT SPACE OPEN IN THE MIDDLE OF
`THE IMPLANT?
`A.
`THE SPACE IS OPEN TO ALLOW PACKING OF BONE GRAFT. SO
`GETTING BACK TO DR. CLOWARD'S BLOCKS, RECTANGULAR BLOCKS OF
`TRANSPLANT BONE, WE SEPARATE THE MECHANICAL DEVICE FUNCTION OF
`INTERBODY FUSION FROM THE BIOLOGIC FUNCTION. WE HAVE AN
`ENGINEERED PLASTIC CARBON THAT SUPPORTS THE PATIENT'S WEIGHT,
`AND WE FILL THAT WITH A PATIENT'S OWN BONE WHICH IS
`BIOLOGICALLY BETTER THAN TRANSPLANT BONE FOR HEALING.
`Q.
`DID YOU SHOW THIS DESIGN TO DR. STEFFEE?
`A.
`YES, I DID.
`Q.
`AT THAT POINT, DID YOU AND DR. STEFFEE DECIDE TO
`DEVELOP IT JOINTLY?
`A.
`HE INVITED ME TO JOIN HIS PRACTICE IN CLEVELAND AND
`
`1 2 3 4 5 6 7 8 9
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`
`1454
`
`0014
`
`
`
`08-CV-1512
`
`TO WORK WITH HIS COMPANY ACROMED TO DEVELOP THIS AND DO THE FDA
`TESTING.
`DID YOU DO THAT?
`Q.
`YES, I DID.
`A.
`WHAT TIME FRAME IS THIS?
`Q.
`I MOVED TO CLEVELAND IN APRIL OF 1990.
`A.
`HOW LONG DID YOU REMAIN IN CLEVELAND?
`Q.
`FOR TWO YEARS.
`A.
`NOW, AFTER BEING IN CLEVELAND UNTIL, WHAT, 1992?
`Q.
`CORRECT.
`A.
`WHAT DID YOU DO?
`Q.
`I THEN MOVED BACK TO OMAHA AND ACCEPTED THE POSITION
`A.
`OF ASSOCIATE PROFESSOR OF SURGERY AND CHIEF OF SPINAL
`RECONSTRUCTIVE SURGERY AT CREIGHTON UNIVERSITY.
`Q.
`WHY DID YOU MOVE BACK TO OMAHA?
`A.
`WE HAD REACHED THE POINT WHERE WE WERE UNDER FDA
`TESTING THROUGH AN IDE PROCESS, AND I THOUGHT THAT WE WOULD BE
`BETTER SERVED IF THIS FDA PROTOCOL AND TESTING WERE DONE IN AN
`ACADEMIC INSTITUTION.
`Q.
`DURING THE 1990S WHEN YOU WERE AT CREIGHTON
`UNIVERSITY, DID YOU SEE PATIENTS?
`A.
`YES, I DID.
`Q.
`DID YOU SEE PATIENTS WHO HAD HAD FUSIONS USING THE
`BAK CAGE?
`A.
`YES, I DID.
`
`1 2 3 4 5 6 7 8 9
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`
`1455
`
`0015
`
`
`
`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?
`
`1 2 3 4 5 6 7 8 9
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`1456
`
`0016
`
`
`
`08-CV-1512
`
`USUALLY, THEY INVITED EVERYBODY THAT WAS INVOLVED
`A.
`DIRECTLY IN DEVELOPMENT IN COMPETING DEVICES. SO I WAS THERE;
`CHARLIE RAY WAS THERE; STEVE KUSLICH WAS THERE; GEORGE BAGBY,
`OFTEN JURGEN HARMS; PAUL MCAFEE WAS A PART OF THAT TOO AND SOME
`OTHER PEOPLE THAT WERE DOING BASIC TESTING ON THE DEVICES WERE
`THERE TO GIVE PRESENTATIONS.
`Q.
`DID DR. MICHAELSON EVER PRESENT AT THESE MEETINGS?
`A.
`NO.
`Q.
`HAVE YOU ATTENDED ANY SURGICAL CONFERENCES AT WHICH
`DR. MICHAELSON SPOKE?
`A.
`NO.
`Q.
`DO YOU RECALL EVER READING ANY JOURNAL ARTICLES
`WRITTEN BY DR. MICHAELSON?
`A.
`NO, I DON'T.
`Q.
`DO YOU RECALL ANY OF YOUR SURGICAL COLLEGES
`MENTIONING READING DR. MICHAELSON'S PAPERS OR HEARING HIM
`SPEAK?
`NO.
`A.
`WHEN YOU WERE CONTACTED BY NUVASIVE'S ATTORNEYS, DID
`Q.
`THEY TELL YOU THAT DR. MICHAELSON WAS CONTENDING THAT HE
`INVENTED IN 1995 SPINAL IMPLANTS THAT COULD BE INSERTED USING A
`LATERAL APPROACH?
`A.
`YES OR WORDS TO THAT EFFECT.
`Q.
`WHAT DID YOU THINK ABOUT THAT?
`A.
`I THOUGHT IT WAS PREPOSTEROUS.
`
`1 2 3 4 5 6 7 8 9
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`
`1457
`
`0017
`
`
`
`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.
`
`1 2 3 4 5 6 7 8 9
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`
`1458
`
`0018
`
`
`
`08-CV-1512
`
`IN THAT TIME FRAME, WERE YOU FAMILIAR WITH THE
`Q.
`MEDTRONIC COMPANIES?
`A.
`YES, I WAS.
`Q.
`AND THEIR PRODUCTS?
`A.
`YES.
`Q.
`WERE YOU AWARE OF ANY PRODUCT OR PROCEDURE FOR
`PERFORMING MINIMALLY INVASIVE SPINE FUSION SURGERY USING A
`LATERAL APPROACH BEING OFFERED BY ANY MEDTRONIC COMPANY?
`A.
`I WAS NOT AWARE OF ANY.
`Q.
`LET'S SWITCH GEARS, AND I'D LIKE TO RETURN TO DX5118.
`WHAT WAS THIS IMPLANT CALLED?
`IT WAS ORIGINALLY CALLED THE BRANTIGAN ANTERIOR IF
`A.
`CAGE. THE NAME HAS BEEN CHANGED SEVERAL TIMES SINCE.
`Q.
`WE HAVE HEARD THE WORD "CAGE," AND HEARD THE WORD
`"IMPLANT." ARE THEY SYNONYMOUS?
`A.
`IN THIS CASE, YES.
`Q.
`WHO, TO YOUR KNOWLEDGE, CAME UP WITH THE NAME
`"CAGE"?
`A.
`Q.
`COME IN?
`THE THREE STANDARD SIZES ARE SHOWN THERE. THE ONE ON
`A.
`THE LEFT IS 33 MILLIMETERS LONG, 36 AND 42 ON THE RIGHT, AND
`THE UP-DOWN, WHICH IS THE ANTERIOR POSTERIOR DIMENSION FROM THE
`FRONT TO BACK, 22, 24, AND 28 MILLIMETERS.
`
`ART STEFFEE CAME UP WITH THAT NAME.
`WHAT SIZES, STANDARD SIZES, DID YOUR OVAL IMPLANTS
`
`1 2 3 4 5 6 7 8 9
`
`10
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`12
`13
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`
`1459
`
`0019
`
`
`
`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.
`
`1 2 3 4 5 6 7 8 9
`
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`
`1460
`
`0020
`
`
`
`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
`
`1 2 3 4 5 6 7 8 9
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`1461
`
`0021
`
`
`
`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.
`
`1 2 3 4 5 6 7 8 9
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`1462
`
`0022
`
`
`
`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
`
`1 2 3 4 5 6 7 8 9
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`1463
`
`0023
`
`
`
`08-CV-1512
`
`THE FDA SAID THAT WE WERE NOT ALLOWED TO PROFIT FROM THE SALE
`OF INVESTIGATIONAL DEVICES, BUT THE COMPANY COULD RECOVER THEIR
`COSTS BY BILLING THE PATIENT.
`MR. MILLER: MR. SAYERS, IF YOU COULD TURN TO 2735 IN
`THE DOCUMENT AND ENLARGE THIS AREA.
`BY MR. MILLER:
`Q.
`DOCTOR, WHAT DO WE SEE HERE?
`A.
`THAT'S THE DESCRIPTION OF THE STANDARD SIZES. THE
`LARGE AT THE TOP WERE 42 MILLIMETERS BY 28. THE LARGE-15 WAS
`15 MILLIMETERS TALL. THE LARGE-13 WAS -- GOSH, THAT SHOULD
`HAVE BEEN 13 MILLIMETERS TALL, BUT ACTUALLY, THE SIZES VARIED
`BECAUSE THE TEETH OR RATCHETS ADDED THREE-QUARTERS OF A
`MILLIMETER TO THE HEIGHT FOR A TIGHT FIT. SO THE MEDIUM-14 WAS
`36 BY 24 BY 14. THE MEDIUM-12 WAS 36 BY 24 BY 12 AND SO FORTH.
`YOU CAN SEE THE DIFFERENT SMALL SIZES AS WELL.
`Q.
`ALL RIGHT.
`WE SEE UP HERE THE A, B AND C. WHAT IS THAT
`REFERRING TO?
`AND MR. SAYERS, IF YOU CAN GO BACK TO THE PRIOR
`
`DRAWING.
`THOSE WERE THE DIMENSIONS THAT WERE LISTED IN THE
`A.
`DRAWINGS. YOU CAN SEE A, B AND C.
`Q.
`GO BACK A PAGE.
`SO "A" IS THE LENGTH?
`"A" IS THE MEDIAL-LATERAL LENGTH, AND THAT'S
`
`A.
`
`1 2 3 4 5 6 7 8 9
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`1464
`
`0024
`
`
`
`08-CV-1512
`
`BASICALLY FROM SIDE TO SIDE ACROSS THE FRONT OF THE SPINE.
`Q.
`AND "B" IS THE ANTERIOR-POSTERIOR OR THE DEPTH?
`A.
`THAT'S THE DEPTH. THE ANTERIOR-POSTERIOR ARE
`BASICALLY IN THIS DIRECTION.
`MR. MILLER: MR. SAYERS, WOULD YOU GO BACK TO THE --
`THAT ONE?
`BY MR. MILLER:
`Q.
`AND SO THESE SIZES OF LENGTHS AND WIDTH CORRESPOND
`WITH WHAT YOU PREVIOUSLY TOLD THE JURY?
`A.
`CORRECT.
`MR. MILLER: MR. SAYERS, IF YOU WOULD GO TO 2737,
`
`PLEASE.
`BY MR. MILLER:
`Q.
`DOCTOR, WHAT DO WE SEE HERE?
`A.
`THAT'S THE SIDE-VIEW OF THE OVAL DEVICE.
`Q.
`AND WHAT ARE THESE?
`A.
`THOSE ARE THE RIDGES OR RATCHETS. WE USE DIFFERENT
`TERMS TO DESCRIBE THEM, RIDGES, TEETH, RATCHETINGS,
`ET CETERA.
`Q.
`WHY DID YOU YOUR IMPLANTS HAVE RIDGES OR RATCHETS?
`A.
`THOSE WERE DESIGNED FOR TWO PURPOSES. ONE WAS TO
`BITE INTO THE VERTEBRAL END PLATE TO ALLOW FIXATION SO THE
`DEVICE WOULD NOT DISPLACE AFTER SURGERY. ALSO, YOU COULD STACK
`THESE ELEMENTS. THESE RIDGES WOULD INTERDIGITATE WITH RIDGES
`OF OTHER DEVICES TO FORM A SECURE FIT.
`
`1 2 3 4 5 6 7 8 9
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`1465
`
`0025
`
`
`
`08-CV-1512
`
`IF WE COULD TURN TO DX5131, PLEASE; DOCTOR, WHAT ARE
`
`Q.
`THESE?
`THOSE ARE THE TECHNICAL DRAWINGS THAT ACROMED
`A.
`EVENTUALLY MADE TO DESCRIBE THE DEVICE.
`MR. MILLER: MR. SAYERS, IF YOU COULD ZOOM IN RIGHT
`
`THERE.
`BY MR. MILLER:
`Q.
`WHAT IS THE DATE?
`A.
`JANUARY 25, 1991.
`Q.
`AND ARE YOU FAMILIAR WITH THIS EXHIBIT?
`A.
`YES, I AM.
`Q.
`AND HOW MANY DIFFERENT DRAWINGS ARE IN IT?
`A.
`IT'S A GROUP OF THREE DIFFERENT SIZES, THE SMALL
`MEDIUM AND LARGE. THIS ONE IS THE LARGE. AND AGAIN, THE
`DIMENSIONS ARE SUBSTANTIALLY WHAT WAS SHOWN IN THE PREVIOUS
`EXHIBIT.
`
`MR. MILLER: MR. SAYERS, IF YOU COULD ZOOM OUT NOW.
`BY MR. MILLER:
`Q.
`DOES THIS SHOW THE RATCHETINGS?
`A.
`THE DETAIL TO THE RIGHT SHOWS THE RATCHETINGS.
`Q.
`WHY WERE YOUR IMPLANTS MADE IN DIFFERENT SIZES?
`A.
`WELL, THE DIFFERENT SIZES IN THE SMALL, MEDIUM AND
`LARGE REFLECTED DIFFERENT AREAS OF THE SPINE THESE WERE
`DESIGNED TO ACCOMMODATE ALL AREAS OF THE SPINE FROM THE
`CERVICAL SPINE, WHICH IS THE NECK, THORACIC SPINE, WHICH IS IN
`
`1 2 3 4 5 6 7 8 9
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`1466
`
`0026
`
`
`
`08-CV-1512
`
`THE CHEST AREA, AND THE LUMBAR SPINE, WHICH IS LOWER. SO ALL
`OF THOSE HAVE DIFFERENT SIZES. ALSO, THE HEIGHTS WOULD VARY
`ACCORDING TO THE SPECIFIC NEED AT SURGERY.
`Q.
`DO YOU RECALL IMPLANTS BEING MADE BY ACROMED IN THE
`EARLY '90S THAT MATCHED UP WITH THESE SCHEMATICS?
`A.
`YES.
`Q.
`ARE THOSE IMPLANTS THAT YOU RECALL THE SAME IMPLANTS
`THAT YOU RECALL USING IN PATIENTS IN THE EARLY '90S?
`A.
`YES. YES, THEY WERE.
`Q.
`NOW, OTHER THAN THE BOOK YOU WROTE, DID YOU WRITE
`ANYTHING ELSE ABOUT YOUR IMPLANTS?
`A.
`YES, I DID.
`Q.
`WERE THOSE -- WHAT DID YOU WRITE?
`A.
`I WROTE NUMEROUS ARTICLES FOR THE PEER REVIEW
`JOURNALS DESCRIBING THE CLINICAL EXPERIENCE AND THE TESTING OF
`THESE DEVICES.
`Q.
`AND WERE THESE ARTICLES PUBLISHED?
`A.
`YES.
`Q.
`WHERE WERE THEY PUBLISHED?
`A.
`GENERALLY IN THE JOURNAL SPINE.
`Q.
`WHAT IS THE JOURNAL SPINE?
`A.
`THE JOURNAL SPINE IS MOST RESPECTED PEER REVIEWED
`JOURNAL DESCRIBING SPINE SURGERY IN THE UNITED STATES.
`MR. MILLER: IF WE COULD PULL UP DX5150, PLEASE,
`MR. SAYERS.
`
`1 2 3 4 5 6 7 8 9
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`1467
`
`0027
`
`
`
`08-CV-1512
`
`BY MR. MILLER:
`Q.
`IS THIS ONE OF YOUR ARTICLES?
`A.
`YES, IT IS.
`Q.
`WHAT IS THIS ARTICLE TALKING ABOUT?
`A.
`THAT DESCRIBES THE TWO-YEAR CLINICAL RESULTS, AND THE
`FIRST 26 PATIENTS THAT WE OPERATED ON WITH THESE VARIOUS CARBON
`FIBER IMPLANTS FOR INTERBODY FUSIONS.
`MR. MILLER: MR. SAYERS, IF YOU COULD TURN TO THE
`THIRD PAGE, PLEASE, AND ZOOM IN ON THIS TABLE.
`BY MR. MILLER:
`Q.
`DOCTOR, WHAT DOES THIS TABLE SHOW US?
`A.
`THAT SHOWS SUMMARIES OF THE INDIVIDUAL PATIENTS. ON
`THE LEFT, WE HAVE THE PATIENT'S INITIALS, ADD FURTHER DETAILS
`ABOUT THE PATIENT SURGERY AND TREATMENT.
`MR. MILLER: IF YOU COULD, ZOOM IN ON THIS LAST PART.
`BY MR. MILLER:
`Q.
`DOCTOR, DO YOU RECALL THE LAST PATIENT THERE, "JC"?
`A.
`YES, I DO.
`Q.
`WHY DO YOU RECALL?
`A.
`HIS NAME IS JUSTIN C. I REMEMBER HIS LAST NAME, BUT
`WE SHOULDN'T SAY IT. I RECALL HIM BECAUSE HE WAS THE FIRST
`PATIENT THAT RECEIVED THE OVAL CAGE.
`Q.
`COULD YOU TELL US WHAT THIS LINE IN THE CHART FROM
`THE JOURNAL OF SPINE TELLS US ABOUT MR. C'S PROCEDURE?
`A.
`IT HAD NO PREVIOUS SURGERIES. THE DATE OF HIS CAGE
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`