MATTER OF MCGINNIS WAS BARD CAN WE PLEASE HAVE APPEARANCES OF COUNSEL. APPEAR
APPEAR (APPEARANCES ENTERED.). CHIEF JUSTICE RABNER: WELCOME. JARED M.
PLACITELLA: , JARED MRS. FOR NEW JERSEY ASSOCIATION FOR JUSTICE. DAVID R.
KOTT: DAVID COULD THE KOTT. WE'RE WITH MILK CARTER AND ENGLISH. DANIEL B.
ROGERS: GOOD MORNING, DANIEL RODGERS. ON BEHALF OF AMICI. CHARLES W. COHEN:
CHARLES CONE ON BEHALF OF PHAOEBGS. CHIEF JUSTICE RABNER: GOOD MORNING
TO ALL COUNSEL AND WELCOME. WITH THE ABUNDANCE OF FINE COUNSEL WE HAVE THIS
MORNING. I'M GOING TO ASK TO THE EXTENT YOU CAN INTOP RATE ARGUMENTS. MR. SLATER
ER. ADAM M. SLATER: SLATE, CHIEF JUSTICE RABNER I WOULD LIKE TO RESEARCH
30 MINUTES EIGHT MINUTES OF REBUTTAL. CHIEF JUSTICE RABNER: IT'S A BIT
MORE WE USUALLY GRANT. ADAM M. SLATER: I'M BEING CAUTIOUS. CHIEF
JUSTICE RABNER: LET'S COUNT ON FIVE AND SEE WHERE WE GO. CHIEF JUSTICE RABNER:
THANK YOU. CHIEF JUSTICE RABNER, JULY OF THE SUPREME COURT. THE APPELLATE DIVISION
IS THE ONLY APPELLATE COURT IN THE UNITED STATES TO HAVE \REPHRASED\REVERSED
A FINDING BY A TRIAL COURT. A DISCRETIONARY FINDING TO CONCLUDE 510(K) EVIDENCE.
THE DECISION ESSENTIALLY FROM OUR PERSPECTIVE IS VERY EQUIVOCAL ANNULET MAYLY
SUBSTITUTED IT'S OWN JUDGMENT FOR THAT OF THE TRIAL COURT WHICH DID A VERY GOOD
JOB OF HANDLING A COMPLEX CASE AND CONSIDERED EVERY ARGUMENT THAT WAS
RAISED ON APPEAL AND THAT WAS CONSIDERED BY THE APPELLATE DIVISION. THE APPELLATE
DIVISION AGREES AND KNOWLEDGE THAT THE TRIAL COURT FOUND THAT THERE IS NO SAFETY
PURPOSE TO 510(K), THAT THERE NOISE DEFINES SPECIFIC REQUIREMENT THAT WAS EVER
ENACTED WITH REGARD TO THESE DEVICES. KNOWLEDGE THE RISK OF CONFUSION AND
PREJUDICE AND SAID THAT THOSE WERE LEGITIMATE CONCERNS OF THE TRIAL COURT AND YET
REVERSED THE DECISION AS WELL RECOGNIZING THE OVERWHELMING WEIGHT OF AUTHORITY IN THE
FEDERAL COURTS OF APPEALS THAT HAVE REVIEWED THESE DECISIONS INCLUDING IN THE
PELVIC MESH LITIGATION PROSECUTE THE MDL ALL OF WHICH AFFIRMED THE DISCRETIONARY DECISION BY THE MDL JUDGE TO EXCLUDE 510(K). ULTIMATELY WHAT THE APPELLATE DIVISION
AT THIS BUT WITHOUT ANY SPECIFIC FINDING OF SOMETHING THAT THE TRIAL COURT DID NOT
CONSIDER BELOW IN IT'S VERY EXHAUSTIVE REVIEW OF THE RECORD FIVE HEARINGS WERE HELD
AT DIFFERENT POINTS DURING THE TRIAL, EXTENSIVE PROFFERS WERE MADE AND THERE'S
REALLY NO EXPLANATION FOR WHY THE 104 HEARING WOULD TRULY BE NECESSARY IF THE
ABUSE OF DISCRETION STANDARD WHICH HAS TO BE MORE THAN WORDS. WHICH HAS TO BE
A POLICY OF OUR COURTS THAT ALLOWS TRIAL COURTS AND TRIAL LAWYERS TO KNOW THAT
THERE'S GOING TO BE FINALITY A FORKED TO EVIDENTIARY DECISION INSIST COMPLEX CASES
OTHERWISE YOU END UP WITH A SITUATION LIKE THIS WHERE WE'RE NOT FIVE YEARS
AFTER TRIAL THE PLAINTIFFS ARE STILL WAITING FOR THEIR JUSTICE TO BE FINALIZED
AND UNDER THE APPELLATE DECISION HAVE TO GO BACK AND RETRY THE CASE AND LIKELY
COME BACK UP ON APPEAL AND EXTEND THIS CASE FOR YEARS MORE. JUSTICE WAINER
APTER: YOU MENTIONED THAT THERE'S NO SAFETY PURPOSE TO A 510(K). I READ, OF COURSE,
LOHR AND EAGLE, BUT WEREN'T BOTH OF THOSE CASES TALKING ABOUT THE 510(K) PROCESS
AS IT APPLIES TO A DEVICE THAT EXISTED ON THE MARKET BEFORE 1976 FOR WHICH
THERE IS NO THE ORIGINAL DEVICE DOESN'T HAVE TO BE SHOWN TO HAVE BEEN SAFE AND
EFFECTIVE AT ANY POINT. THERE'S THIS GRANDFATHERING CLAUSE. FOR A DEVICE
I WANT DUES HAD AFTER 1976 DOESN'T THE PREDICATE ITSELF HAVE TO HAVE BEEN FOUND SAFE
AND EFFECTIVE IN ORDER FOR THE PREDICATE TO HAVE BEEN SOLD IF IT WAS INTRODUCED
AFTER 1976. ADAM M. SLATER: I DON'T BELIEVE SO. IN FACT, I BELIEVE THAT
DISTINCTION WHICH OBVIOUSLY IS RAISED IN THE PAPERS FROM THE DEFENSE AND FROM
AMICI ON THE DEFENSE SIDE IS POINTING TO THE SAFETY EIGHT OF 19 INNOCENT IF WE
LOOK AT THE TESTIFY HISTORY WHICH BY RIGHTED IT ACTUALLY RECOGNIZE WHAT IS THAT
REGULATION DID WAS INCORPORATE THE POLICY THAT ALREADY EXISTED. THESE DEVICES
EMANATED FROM A FINDING BY A PANEL IN 1988 REGARDING SURGICAL MESH WHEN I WAS A
BROAD TERM AND ACTUALLY IN THE LANGUAGE OF THAT FINDING TALKS ABOUT SURGICAL MAKE
USED FOR HERNIA REPAIRS AND ORTHOPEDIC BONE JOINT SURGERIES. THAT IS YOU WILL
PENNSYLVANIA MATILY WHERE ALL OF THIS BEGAN. SO I DON'T BELIEVE THAT THESE
DEVICES ARE LINKED TO A PREDICATE THAT ACTUALLY WAS FOUND TO BE SAFE AND
EFFECTIVE THROUGH THE PRE MARKET APPROVED PROCESS. JUSTICE WAINER APTER:
SO THAT SEEMS LIKE A DISAGREEMENT WITH THE LEVEL OF SPECIFICITY ALTHOUGH WHICH
THE FDA IS UNDERTAKING THE 510(K) PROCESS RATHER THAN REFUTING THAT THE SURGICAL
MESH EVEN IF YOU THING THE SURGICAL MESH IS NOT RELATED OR THE SAME TECH LOGICALLY
AS THE PRODUCT IN THIS CASE, DO YOU AGREE THAT THE SURGICAL MESH IN 1982 I
THINK THE FDA MENTIONED IT HAS AN ESTABLISHED HISTORY OF SAVE AND EFFECTIVE
USE AND THEN IN 1988 THEY ORALLY CLASSIFY IT AS CLASS TWO DEVICE WHICH IN EFFECT
THEY HAVE FOUND IT IS SAFE AND EFFECTIVE. ADAM M. SLATER: I'M GLAD YOU
ASKED THAT QUESTION. THAT ISSUE PERM NATURES OR UNDERLIES A LOT OF THIS. IN
FACT, THE FDA DID NOT REALLY MAKE A SAFETY FINDING. AND WHEN I TALK ABOUT SAFETY
I WANT TO TALK ABOUT -- AND I'M HOPING TO COMMUNICATE CURING THIS ARGUMENT TODAY.
WHAT HAPPENED AT TRIAL ONE OF THE ISSUES RAISED BY THE APPELLATE DIVISION
IS A SUGGESTION THAT IN TRYING THE CASE I TOOK ADVANTAGE OF THE DECISION BY
TALKING ABOUT THE LACK OF CLINICAL STUDIES. YOUR QUESTION REALLY RAPS INTO THAT.
BECAUSE THESE DEVICES ARE ACTUALLY SURGICAL SYSTEMS AND THEY WERE SOLD AS
PROCEDURES AND SYSTEMS. IT WAS NOT JUST THE MESH. AND IN FACT, THE SCIENTIFIC
AND MEDICAL LITERATURE WHICH WAS REALLY AT THE HEART OF THE CASE TALKS ABOUT
THESE AS PROCEDURES UTILIZING MESH BUT ALSO UTILIZING THE INSTRUMENTS TO PLACE IT
IN THE BODY AND THESE INNOVATIVE TESTIFY UNFORTUNATELY IT TURNED OUT TO BE
POOR INNOVATION AND THESE PRODUCTS DON'T EXIST ON THE MARKET ANY MORE. THE
PACKET THAT THE TRIAL JUDGE IN IT'S DISCRETION IN BALANCING THE TRIAL DIDN'T
LET THE JURY KNOW EITHER THAT THE PRODUCTS HAD BEEN WITHDRAWN T CRITICISMS ARE OF
THE PROCEDURES. THE MESH IS A PART OF IT AND IT'S A PART OF THE PROBLEM. BUT
ULTIMATELY AT TRIAL WHAT WE WERE ARGUING ABOUT WAS THE MEDICAL RISK BENEFIT
TO ESTABLISH SAFETY FOR THESE PROCEDURES. AND THAT'S WHAT WE WERE TALKING
ABOUT WHEN WE TALKED ABOUT CLINICAL STUDIES AT TRIAL. IN FACT, THE 510(K) PROCESS
DOES NOT INCORP RATE A MEDICAL RISK BENEFIT AT ALL. IF YOU LOOK AT THE ACTUAL
REGULATIONS AND THE ACTUAL STATUTE WHERE AS PRE MARKET APPROVAL ACTUALLY REQUIRES
A RISK BENEFIT ANALYSIS. THIS ENTIRE TRIAL WAS FOCUSED ON THE CONCEPT OF MEDICAL
RISK BENEFIT. SO FOR EXAMPLE, WHEN THE APPELLATE DIVISION SAYS WELL IT WAS UNFAIR
NOT TO LET THE DEFENDANTS TELL THE JURY AT LEAST THAT THE FDA DID NOT REQUIRE
CLINICAL STUDIES WHEN YOU LOOK AT THE FORMS THAT ARE CITED IN THE APPENDIX
AND I HAVE ALL THE CITES IF ANYONE NEEDS THEM. IT'S ACTUALLY THE CHECK LIST WERE
CLINICAL STUDIES NEEDED TO PROVE SUBSTANTIALLY KIND OF LENS, NOT WERE
CLINICAL STUDIES NEEDED TO PROVE SAFETY. SUBSTANTIAL KIND OF LENS WAS NEVER
A QUESTION AT TRIAL. IT WAS NEVER AN ISSUE. JUSTICE WAINER APTER: I UNDERSTAND
BUT I WANT TO MAKE SURE I UNDERSTAND YOUR ANSWER TO THE PREDICATE. IF YOU'RE
PROVING SUBSTANTIAL KIND OF LENS TO A PREDICATE THAT WAS PROVEN SAFE AND
EFFECTIVE ARE YOU ALLEGING THAT THE PREDICATE WAS NEVER PROVEN SAFE AND EFFECTIVE
OR JUST THAT THIS DEVICE WAS NOT CONNECTED ENOUGH TO THE PREDICATE SUCH THAT THE
FDA SHOULD NOT HAVE ISSUED THE FINDING OF SUBSTANTIAL KIND OF REMEMBERS UNDER
510(K). ADAM M. SLATER: MY UNDERSTANDING IS FROM ALL THE LANGUAGE
AND CASE LAW AND EVERYTHING WE RESEARCHED THAT THERE WAS NOT SOMETHING IN THE TREE
GOING BACK TO THE ROOT THAT WAS ACTUALLY FOUND TO BE SAFE AND EFFECTIVE UNDER PRE
MARKET APPROVAL. THIS EMANATED FROM A PANEL DECISION CLASSIFYING SURGICAL
MESH IN 1988 AS CLASS TWO AND ALLOWING 510K TO RUN FROM THAT POINT FORWARD. SO YOUR
KNOWLEDGE THERE IS NO PRE MARKET APPROVED PRODUCT IN THE CHAIN. AND IT'S A GOOD
QUESTION BECAUSE EVEN IF THERE HAD BEEN, THERE WAS NEVER A SHOWING THAT A PARTICULAR
DEVICE IN THE CHAIN WAS PRE MARKET APPROVED AND THAT THIS PRODUCT WAS SO SIMILAR
THAT A SAFETY FINDING WOULD BE EQUIVALENT. THAT WAS NEVER SUBMITTED. THERE'S
NOTHING IN THE RECORD. THERE'S NOTHING IN THE FDA EXPERT FROM BARD REPORT
OR DEPOSITION TESTIMONY IT'S JUST NOT AN ISSUE EVER RAISED. UNIDENTIFIED
PERSON: PERSON YOUR ISSUE. ADAM M. SLATER: MY POINT IS SURGICAL MESH WHEN
YOU SAY SURGICAL MESH AS A CATEGORY OR THE MEASURE IN THE AVAULTA LINE ITSELF. THE
FDA PANELS AND 82 APPROVED AND SAID THAT THEY WERE REASONABLY THAT THEY HAD
GOOD HISTORY OF BEING SAFE AND EFFECTIVE, ESTABLISHED HISTORY OF SAVE AND
EFFECTIVE USE. THE SURGICAL. ADAM M. SLATER: THE SURGICAL MESH THAT WAS
THE 19 CREATE PANEL FINDING COULD BE SAFE IF IT WAS USED IN AN INDICATION THROUGH
A PROCEDURE THAT WOULD SAFELY USE IT. BUT THE THING WITH FIVE 510(K) IS IT
DOESN'T SAY THIS IS HOW IT'S GOING TO BE USED IN ALL CASES. A ITS A VERY BROAD
FINDING. JUST LOOK AT WHAT WE HAVE HERE. WE HAVE AGAIN LOGICAL DEVICES FOR PELVIC
RECONSTRUCTIVE SURGERY PUT IN FOR COLLECTION OPERATIONS THAT WERE REVOLUTIONS AREA
ACCORDING TO THE INDUSTRY AND ACCORDING TO COMPANIES THAT BARD THAT CHANGED THE
MEDICAL VERB. WITH PROLAPSE AND STRESS HE KNOWS CONTINENCE THIS WAS A NEW USE.
IT'S NOT JUST THE HE BE MESH MATERIAL WHICH BY THE WAY IS NOT THE SAME PELVIC MESH
MATERIAL THAT WAS APPROVED IN CLEARED IN 1988. IT'S VERY POLYPROPYLENE. VERSUS
MARCH POUR SIZES VARIOUS WEIGHTS AND DENSITIES. WHICH AGAIN AT TRIAL WE WERE
ARGUING VARIOUS POLYPROPYLENE MESH MATERIALS AS ONE PART OF THE SYSTEM JUSTICE JUSTICE
DIDN'T THE SYSTEM FIND IT HAD AN ABDOMEN HISTORY OF SAVE AND EFFECTIVE USE.
ADAM M. SLATER: SLATE ALL THE FDA DID WAS FOR THE SAME INTENDED USE IN
GENERAL MEANING PUT IN THE BODY TO SUPPORT SOME STRUCTURE AND THAT THERE'S
NO DIFFERENT TECH ALMOST CHARACTERS. A THAT WAS THE FINDING THERE WAS NO FINDING
OF SAFETY. JUSTICE WAINER APTER: THAT SOUNDS LIKE AN OBJECTION TO THE
510(K) PROCESS ITSELF. YOU'RE SAYING FDA IS ALLOWING TOO MUCH OF A DIFFERENCE
BETWEEN THE PREDICATE AND WHATEVER THE NEW DEVICE IS TRYING TO BE USED AND STILL
FINDING SUBSTANTIAL EQUIVALENT. THAT YOUR ARGUMENT OR WAS THE PREDICATE NEVER
AGGRAVATING FACTOR AND EFFECT FIVE TO BEGIN WITH OR IS IT BOTH. ADAM M. SLATER:
I THINK IT'S BOTH WEEK HAVE ASKINGS IN THE LITERATURE ABOUT WHETHER 510(K) SHOULD
EVEN BE IN EXISTENCE AND THERE'S A LARGE CONTROVERSY THAT IT'S ACKNOWLEDGED IN
THE LITERATURE OVER THAT QUESTION. BUT WE DON'T HAVE TO ANSWER THAT QUESTION TODAY.
THE ONLY QUESTION TODAY IS DOES 510(K) PROVIDE SO MUCH PROBATIVE EVIDENCE
THAT THAT PROBATIVE VALUE OUT WEIGHS THE MASSIVE PREJUDICE THAT EVEN THE
APPELLATE DIVISION AND EVERY SINGLE CASE CITED BY THE DEFENSE ALLOWING IN HAS
ACKNOWLEDGED. I MEAN I TAKE THE DIOVAL CASE WHICH I FIND THE DEFENSE ACTUALLY CITED
ARE THE DIOVAL HERNIA MESH CASE WHERE THE JUDGE SAID I FIND IT'S NOT ABOUT
SAFETY. I'M NOT GOING TO LET ANY EXPERT TALK ABOUT THE 510(K) PROCESS BECAUSE
THAT'S GOING TO BE TOO CONFUSING. THERE'S GOING TO BE NEED SIGNIFICANT EXPLANATORY
LIMITED INSTRUCTION AND THE JUDGE SAID SOMETHING VERY INTERESTING IN THE FOOTNOTE
TO THAT DECISION. THE JUDGE SAID NOW I'M AWARE OF ALL THESE CIRCUIT COURT
OF APPEAL DECISIONS THAT HAVE AFFIRMED EVERY JUDGE THAT HAS SAID IT SHOULD BE
KEPT OUT. WHAT THE JUDGE SAYS THAT IS A FUNCTION NOT OF THE FACT THAT IT CAN NEVER
COME IN. I WOULD DISON FREE WITH THAT BUT I DON'T HAVE TO WIN THAT BATTLE
BUT IT'S A FUNCTION OF THE ABUSE OF DISCRETION FUNCTION AN APPLIED. THAT'S
WHERE WE REALLY ARE. I THINK THESE ARE VERY GOOD QUESTIONS I HAVE STRONG WHETHER OR
NOT 510(K) SHOULD EXIST AT ALL. BUT IT'S SO LIMITED AND IT'S SO TANGENTIAL TO THE
CONCEPT OF SAFETY THAT IT SHOULD NOT BE A PIECE OF EVIDENCE AT A TRIAL WHERE
THE ENTIRE ISSUE IS WAS THE PRODUCT DESIGNED IN A SAFE AND EFFECTIVE MANNER
BASED ON MILK RISK BIENNIA WERE THE WARNINGS ADEQUATE BASED ON MEDICAL RISK
BENEFIT. AND I WAS GOING TO SAY THERE ARE MANY ISSUES IN THIS CASE THAT ACTUALLY
DON'T TRANSLATE TO 510(K) AT ALL. FOR EXAMPLE, THE IMPLANTING DOCTOR TESTIFIED
SHE NEVER WOULD HAVE USED THE PRODUCT IF SHE NEW VARIOUS THINGS. WOULD BE
OF THE THINGS SHE ASSUMED BASED ON THE STATEMENTS AND THE CLAIMS MADE FOR
INSTRUCTIONS FOR USE WHICH WAS THE PANELING AGE THEY MUST HAVE HAD LONG TERM DATA
TO MAKE ALL THESE CLAIMS SHE ASSUMED THAT AND WAS ONE OF THE BASIS FOR USING
THE PRODUCT AND SHE SAID I DIDN'T KNOW THAT. I WOULDN'T USE THAT IF I DIDN'T
KNOW THEY HAD LONG TERM DATA. THAT HAS NOTHING TO DO WITH THE 510(K) AND 510(K)
DOESN'T SPEAK TO IT. THIS WOULD CONFUSE THE PROOFS ESSENTIALLY AND THE TRIAL
JUDGE WHO KNEW THIS RECORD OF THE 25 WITNESSES THAT WERE COMING IN, THE TEN
EXPERT AND UNDERSTOOD ALL THIS BALANCED ALL OF THIS AND MADE A REASONABLE EXERCISE
OF DISCRETION AND THAT'S REALLY AT THE HEART OF WHAT WE'RE HERE FOR. MR. JAO:
DOES IT MATTER THAT MS. MCGINNIS HAD BOTH THE AVAULTA SOLELY LOW DEVICE TO CORRECT
PROLAPSE IMIMPLANTED AS WELL AS THE A LINE DEVICE TO STREET THE STRESS URINE NERA
CONTINENCE. ADAM M. SLATER: WHEN I SAW DOES IT MATTER. MR. JAO:
ONE OF THOSE PRODUCTS, A LINE IS STILL ON THE MARKET SLIGHT SLIGHT IT IS NOT. MR.
JAO: BUT IS THAT TECHNIQUE THAT SLING TECHNIQUE IS STILL ON THE MARKET.
ADAM M. SLATER: WELL IT'S A GOOD QUESTION. IN GENERAL. MR. JAO: I TRY.
ADAM M. SLATER: IN GENERAL THE SLING BY THE TRANCE OPEN ARE TORE APPROACH
IS STILL ON THE MARKET FOR A COUPLE DEVICE. VIRTUALLY EVERY ONE OF THEM IS
NO LONGER SOLD AND IT'S VERY INTERESTING BECAUSE THERE'S TREMENDOUS LITERATURE
THAT WE OKAYED USED IN THIS TRIAL WHERE SCIENTIFIC LITERATURE PIER REVIEWED SAID
TAKE OPERATOR ARMED MESH SHOULD NO LONGER BE USED PROBLEM IS WHERE THE GROIN WHERE
THE OPERATOR NERVES ARE IN AN AREA WHERE IT'S A NOT AGAIN LOGIC. IT'S AN AREA
GYNECOLOGISTS ARE NOT TRAINED TO OPERATE IN THE GRADE. THEY'RE TEARING THROUGH
NERVES. TEARING THROUGH MUSCLES AND THAT IS ONE OF THE MAIN PROBLEMS FOR MARY
MCGINNIS SO WHERE I ACTUALLY WOULD LIKE TO TAKE THIS IS ONE OF BIG PROBLEMS IS THEY
NEVER TOLD ANYBODY IF YOU'RE GOING TO PUT THE AVAULTA WITH THE ARMED OPERATOR RAY
TORE ARMS INTO THE BODY AND THE ALIGN WITH THE ARMS YOU'RE DOUBLING THE MESH
LOAD IN THE GROIN AND OUR EXPERT MADE A STRONG POINT TO THE MESH LOAD IS A KEY
HOW STRONG THE INFLAMMATORY ACTION. HOW BAD THE SCARRING IS HOTCHING ACHE CASCADE.
IF YOU SAW DR. RAZ WHO ULTIMATELY OR THE HAD ON IN ASS ON MARY MCGINNIS HE HAD
TO GO INTO HER GROIN NOT THROUGH THE VAGINA THROUGH THE GROIN, THROUGH THE
LEGS. HE HAD TO TAKE OUT THE MESH IT IS INCREDIBLY MORE BID VERY DIFFICULT
SURGERY AND HE HAD TO USE CART PRESCRIBED AS BEING CEMENTED TO THE PEW BIG UPON IN THE
INITIAL SPINE. SO AGAIN, THIS PROCEDURE WAS SO HORRIBLY UNSAFE THAT THE SCIENCE
AND THE MEDICAL COMMUNITY AROUND IT HAS SAID OPERATOR RAY TORE SLINGS ARE SO
DANGEROUS THEY SHOULDN'T BE USED AND I CAN TELL YOU LESS AND LESS ARE USED
EVERY DAY AND I BET DOLLARS TO DONUTS YOU WON'T SEIZE THESE PROCEDURES BEING DONE
FIVE YEARS FROM NOW BECAUSE SO FEW OF THEM ARE BAG BOUGHT BY DOCTORS NOW, THE
SALES ARE GOING DOWN BECAUSE DOCTORS ARE RECOGNIZING AND I'M IN THESE DEPOSITIONS
ALL THE TIME. I HEAR THE DOCTORS I WON'T USE IT I'LL ONLY USE A DIFFERENT
TIP THE SLINGS ANOTHER ONE OF THE 510(K) THE SLINGS CAN BE PLACED IN THE OPERATOR
RAY TORE OR THEY CAN RETRO PUBIC SPACE BEHIND THE PUBIC BONE. VERY DIFFERENT
SURGERY. YOU DON'T UP THE THE GROIN, YOU DON'T GO THROUGH THE CAN DENY DISMISSAL
FIVE. THAT IS WHAT MS. MCGINNIS \IN YOUR\NEWER ALONG GENTLEMAN. HER NOTIFY
IS SO DAD SHE STOOD FOR MOST OF THE TRIAL IN THE BACK OF COURTROOM AND STOOD WHEN
SHE TESTIFIED FOR THE MOST PART. JUSTICE SOLOMON: CAN I STOP YOU FOR ONE,
CAN I STEEL A WATER WHILE AUTO DOING THAT JUSTICE SOLOMON SOLE ABSOLUTELY.
I GET THERE WAS A LONG AND COMPLICATED TRIAL INVOLVING WHAT THE PLAINTIFF ARGUES
IS A DEFECTIVE PRODUCT. WE'RE CONCERNED WITH 510(K) AND IT SOUNDS LIKE WHAT
YOUR ARGUMENT DIFFICULTIES TILLING IT DOWN TO SOMETHING EVEN I MAY BE ABLE TO UNDERSTAND
IS THAT THIS WAS A NEW USE FOR THE MESH THAT HAD BEEN APPROVED AND THEREFORE
510(K) DOESN'T APPLY BECAUSE IT DOESN'T APPLY TO A NEW INTENDED USE THAT HAS
DIFFERENT RISKS, DIFFERENT, YOU KNOW, HAZARDS, DIFFERENT -- IT JUST DID YOU
WANT APPLY HERE BECAUSE IT'S A NEW INTENDED USE. ADAM M. SLATER: I'LL REPHRASE
IT SLIGHTLY CONTROL CONTROL PLEASE. ADAM M. SLATER: I DON'T THINK IT SHOULD
APPLY AND IN FACT PROBABLY STILL ON THE RECORD THE FDA ELAPSED THE PROLAPSE
EVALUATE AVAULTA AS CLASS THREE DEVICES ONCE THEY LEARNED HOW DANGEROUS THEY WERE.
JUSTICE SOLOMON: THAT ALL POST DATES IN. ADAM M. SLATER: I REALIZE
THAT. JUSTICE SOLOMON: IT SOUNDS LIKE YOUR ARGUMENT IS WHY DO WE NEED
A 104 HEARING. WHY DO WE NEED TO EVEN CONSIDER 510(K) BECAUSE THIS IS NOT THE
SAME DEVICE, THIS IS A NEW INTENDED USE WHICH TAKES IT OUT OF 510(K) AND WE'RE
TALKING ABOUT THE LONG THINGS HERE. ADAM M. SLATER: I THINK THAT'S ONE OF THE
STRONG POLICY REASONS TO NOT ELEVATE 510(K) BEING ADMITTED. BECAUSE 510(K)
IS SO BIG IT LET'S EVERYTHING THROUGH THAT CAN FIT THIS GENERAL CATEGORY OF THE
MESH. AND AGAIN DOESN'T LOOK AT HOW IS IT BEING USED. WHAT IS THE MEDICAL
RISK BENEFIT OF THIS. WHAT PART OF THE BODY HOW BEING PLACED. I CAN'T ARGUE IT
CANNOT GET IN THROUGH 510(K) IT DID. WE'RE NOT CHALLENGING THE FDA FINDING.
THAT'S NOT FOR ME TO DO TODAY. BUT I THINK IT POINTS OUT HOW WEAK 510(K)
IS AND WHAT THE PROBATIVE VALUE -- WE WOULD SAY NONE IS SO -- EVEN THE COURTS \HAD
A\WHAT HAVE ALLOWED IT IN SOLO THAT YOU DON'T LET IT IN BECAUSE THE PREJUDICE
IS SO MASSIVE. JUSTICE PIERRE-LOUIS: SO GOING BACK TO WHAT YOUR ARGUMENT IS
CONSIDERING WHAT OCCURRED IN THIS CASE THERE'S NO NEED TO FIND THE APPELLATE
DIVISION SHOULDN'T HAVE FOUND THERE WASN'T ANY ABUSE OF DISCRETION HERE CONSIDERING
EVERYTHING THAT THE TRIAL COURT CONSIDERED DURING THE HEARINGS, THERE'S NO
NEED FOR ADDITIONAL 401 HEARINGS AND WE SHOULD NOT FIND THAT THE TRIAL COURT
ABUSED ITS DISCRETION. ADAM M. SLATER: THAT'S THE BOTTOM LINE OF MY ARGUMENT.
I'LL TELL YOU SOMETHING VERY TESTING AGAIN I CAME IN HERE SENSITIVE TO THE CLINICAL
STUDIES ISSUE THAT SORT OF PERMEATED THE SITUATION. THIS FORTIES THE FDA EXPERT
FOR BARD IN THE PROFFERED REPORT ONE OF THE OPINIONS SHE WAS GOING TO GIVE.
EVEN IF A CLINICAL STUDY COMPARING THE AVAULTA TO PREDICATE PRODUCTS HAD BEEN
DIRECTED TO BE DONE BY THE FDA BECAUSE I'VE EXPLAINED THAT ONLY GOES IS IT
SUBSTANTIALLY EQUIVALENT TO SOMETHING ELSE NOT TO PROVE IT SAFE AND EFFECTIVE
THAT WOULD NOT ANSWER THE TECH OF THE TRANSVAGINAL LESS PROLAPSE REPAIRS. EVEN
THEIR OWN EXPERT ADMITS THE TYPE OF CLINICAL STUDY THE FDA WOULD ORDER IN A
SUBSTANTIAL KIND OF LENS REVIEW UNDER 510(K) WOULD NOT ANSWER THE SAFETY ISSUES
WHICH WERE AT THE HEART OF THE TRIAL. CHIEF JUSTICE RABNER: HOW DO YOU
INTERPRET THE APPELLATE DIVISION DECISION, IT ORDERS A NEW TRIAL. IT ORDERS
A 104 HEARING BUT SAYS IT DOESN'T PREJUDGE THE OUTCOME OF THE HEAR. IS THE
TRIAL COURT UNDER THE OPINION OF THE APPELLATE DIVISION OBLIGATED TO ALLOW SOME
OF THE EVIDENCE TO BE INTRODUCED AND IF NOT WHAT'S THE BASIS FOR A NEW TRIAL.
ADAM M. SLATER: I AGREE, THE APPELLATE DIVISION EX SPLITLY SAYS THEY'RE
NOT PRE JUDGING THE OUTCOME AND THEY'RE NOT SAYING THAT THE JUDGE CAN'T COME
OUT WITH THE SAME DECISION AS BEFORE. IT JUST SAYS THEY WANT DEEPLY RADIO
CONSIDERED. WHY WAS A NEW TRIAL ORDERED WHY WAS THIS DONE. WE OBVIOUSLY SHARPLY
DISAGREE BECAUSE WHAT IF -- I THINK WHAT YOU'RE GETTING -- SO IF THE TRIAL
SISSY DID HEARING I HEARD EVERYTHING I HEARD BEFORE. I LET SOMEONE TESTIFY
TO IT. I HAVE THE SAME OUTCOME NOW WE HAVE TORY TRY THE CASE WHEN EVERYTHING ELSE
WAS FOUND TO BE APPROPRIATELY HANDLED AND THERE'S NO OTHER ISSUE. SO IT'S GROSSLY
UNFAIR AND AGAIN IN A CASE LIKE THIS IT'S A PIT BUSTLING AS TO WHY THAT FINDING
WAS MADE BECAUSE NOW YOU PUT OBVIOUSLY THE MCGINNIS' THROUGH ANOTHER TRIAL.
ANOTHER APPEAL. MASTIFF PERSONS AND THEY'RE GETTING OLDER. MARY IS 76 YEARS OLD
NOW IT'S TOUGH. CHIEF JUSTICE RABNER: CAN YOU ADDRESS AN ARGUMENT
THAT THE DEFENSE HAS PUT FORWARD THAT IF YOUR THAN TWO PRE MARKET APPROVAL PROCESS
AND THAT THE TESTIFY HISTORY SUBJECTS THAT THE NOT INTENDED SOLELY TO ADDRESS
THAT. ADAM M. SLATER: WELL I THINK WHAT THAT TELLS US IS 510(K) WAS AN INDUSTRY
FRIENDLY EXCERPTS AND THE COURTS TALK ABOUT IT. IT WAS MEANT TO PROMOTE COMPETITION
TO LET OTHER COMPANIES COPY BASICALLY SOMETHING ELSE THAT WAS OUT THERE AND
GO AND SELL THEIR MEDICAL DEVICES MORE QUICKLY AND CHEAPLY. SO THAT'S --
THAT'S WHAT 510(K) IS FOR. THE FACT THAT IN VERY FEW DEVICES GO THROUGH PRE MARKET
APPROVAL IS BECAUSE WHO WOULD EVER WANT TO DO THAT. YOU THE SAW THE DOCUMENTS
AND THE TESTIMONY SPEED TO MARKET WAS A CONCEPT OF IN THERE POWER POINTS IN THE
MARKETING DEPARTMENT WHICH RAN THE WHOLE THING WHICH WE NEED TO GET TO MARKET
QUICKLY BECAUSE OTHER COMPANIES ARE AHEAD OF AND IF WHICH DON'T START DOCTORS USING
OUR PRODUCT WE WON'T GET A BITE OF THIS MULTIPLE TENSE BILLS DOLLARS. THAT'S
WHAT EXCEPTION FROM OUR PERSPECTIVE TO LET COMPANIES GET PRODUCTS TO MARKET
QUICKLY. JUSTICE WAINER APTER: DIDN'T FDA HADED ON IN THIS CASE -- IT WAS
A MULTIPLE MONTH REVIEW OF THE 510(K) SUBMISSIONS, CORRECT. ADAM M.
SLATER: I DON'T REMEMBER THE EXACT TIME PERIOD IT TOOK THEM TO GET IT. IT WAS
MAYBE A FEW MONTHS. JUSTICE WAINER APTER: AND DIDN'T THEIR ORDER SAY
SOMETHING LIKE THE SUBJECT DEVICES COMPONENTS HAVE BEEN ADEQUATELY POSSESS BY A
COMPATIBILITY DETERMINATIONS FOR SAFETY AND VIA PHYSICAL STRENGTH AND CHARACTERIZATION
ASSESSMENTS FOR PREDICATE -- FOR PREDICTION OF EFFECTIVENESS. THEN THE PRODUCT
IS SUBSTANTIALLY EQUIVALENT. SO ISN'T THIS -- BECAUSE AGAIN, THE PREDICATE
WAS ALREADY HELD TO BE SAFE AND EFFECTIVE, ISN'T THE FINDING OF SUBSTANTIAL
KIND OF LENS SPECIFICALLY FOR SAFETY AND EFFECTIVENESS, NOT JUST THAT IT'S THE
SAME AS A DEVICE SOLD BEFORE 1976 THAT HAD BEEN GRANDFATHERED IN. ADAM M.
SLATER: NO, WHAT THEY'RE ACTUALLY EVALUATING IS DOES IT SUBSTANTIALLY EQUIVALENT
TO THE OTHER MATTERS, IT'S A ISO. INTERNATIONAL STANDARDS ORGANIZATION STANDARD
THAT AWFUL THESE MESH COMPANIES USE -- IT REALLY STEPS INTO AN AREA I WAS HOPING
TO TALK TO CALLED DESIGN CONTROL. WHETHER IT'S A REMARK APPROVED PRODUCT OR
510(K). THE MEDICAL DEVICE THEY HAVE TO PUT IT THROUGH A DESIGN PROCESS AND
OWENS TERM PROCESS THEY ALL FOLLOW ESSENTIALLY THE SAME OKAY. HAD AND IN THIS
CASE THAT INTERNATIONAL STANDARDS ORGANIZATION STANDARD WAS UTILIZED AND IT'S
ONLY INTENDED TO SHOW THAT IT'S SUBSTANTIALLY EQUIVALENT. YES, IT ANSWER AS
COUPLE QUESTIONS WIRABLE AL LOW LEVEL SAFETY QUESTIONS AND ALL IT TALKS ABOUT IS
DOES IT ACTUALLY HAVE A SAFE INTER FACE WITH TISSUE IN GENERAL. IT DOESN'T LOOK
AT ANY OF THE ISSUES THAT WE'RE ACTUALLY TRIED. AND IN FACT. WHEN I QUESTIONED
THE WITNESSES I ASKED THEM WELL DO ANY OF THESE STANDARDS THAT WE'RE TALKING ABOUT
HERO OH BECAUSE WHAT THEY DID THOUGH ROLLED A LIBRARY CART IN WITH 30,000 PAGES OF
DOCUMENTS GOING THROUGH THAT TYPE OF TESTING JUSTICE. THEY SAID LOOK THIS IS SAFE
WE DIDN'T NEED CLINICAL STUDIES. AND INTACT THAT'S NOT THE ONLY STANDARD THEY
APPLIED. THEY APPLIED OTHER STANDARDS AND DID WHAT'S CALLED A CLINICAL EVALUATION
REPORT WHICH THEY HAD TO FIND THAT THE DEVICES BENEFITS OUT WEIGHED THE RISKS
ON A MEDICAL BASIS. AND WHAT THEY DID IS -- AND THIS IS AGAIN WHY WE TALKED ABOUT
CLINICAL STUDIES AND WHY 510(K) IS SO IRRELEVANT TO THE CASE. THE COMPANY MADE
A CHOICE THEY COULD HAVE CHOSEN UNDER A DIFFERENT STANDARD THEY APPLIED. A
LITERATURE REVIEW A CLINICAL STUDY OR A COMBINATION OF BOTH. THEY CHOSE THE
LITERATURE PATHWAY ON HIM. THEY DID THAT'S IT'S THE FASTER CHESTIEST WAY TO MARKET.
PART OF THIS LIST YOU MADE A CHOICE BASED ON YOUR OWN STEIN PROCESS HAD NOTHING
TO DO 510(K) IT HAD TO DO WITH THE FACT THIS THEY DID THE ANALYSIS WHAT WE
DEMONSTRATED WAS THAT THE LITERATURE THEY ACTUALLY RELIED ON CUT THE OTHER WAY
AND THEY JUST IGNORED. ARTICLES THAT THEY RELIED ON SAID THAT THESE DEVICES AND
THESE PROCEDURES AND CONSISTENTLY TALKED ABOUT PROCEDURES ARE UNSAFE, THE EROSION
RATES OF 20 PERCENT ARE TOO HIGH. THEY LOOKED AT STUDIES WITH THE PRIOR
PRODUCT. THE AVAULTA CLASSIC WAS THE PRODUCT THEY MODELED THE AVAULTA ON, AND
THE EROSION RATES AND THE DIFFICULTIES PER IAN YA RATES AND PAIN RATES WERE
SO HIGH THAT THE AUTHORS IN THOSE STUDIES SAID THAT THEY WERE UNSAFE. THE CHIEF
ENGINEER WHO EVALUATED THE DANGEROUS PROPERTIES OF THESE PRODUCTS A GUY NAMED
BOB ARE ACTUALLY IT HAD STUDIES FOR THE VAULT CLASSIC SAID THAT DATA IS NOT
A GOOD AND ACCEPTABLE PRODUCT. ANOTHER THING THEY RELIED ON ANIMAL STUDIES UP TO
30 AND 90 DAYS. THEIR VICE PRESIDENT OF CLINICAL AFFAIRS TESTIFIED IN A
DEPOSITION THAT IT WOULD NOT GOOD GOOD SCIENCE TO RELY ON AN INNOCENT DAY STUDY
TO PROJECT FOR A FURTHER PERIOD OF TIME WE'RE TALKING ABOUT PERMANENT DEVICES.
THOSE STUDIES WE REALLY TORE TO PIECES AT TRIAL BECAUSE WE ASKED THE WITNESSES,
THE DESIGN EXPERT THEY BROUGHT IN AND MR. KEY ROY WHO WAS THE GUY IN CHARGE
OF THIS THOSE STUDIES DID THEY TELL US THERE WAS GOING TO BE EROSION. JUSTICE
WAINER APTER: WHAT I READ FROM IS THE FDA'S ORDER RIGHT. ADAM M. SLATER:
IT'S THE REVIEW -- I THINK YOU HAVE THE REVIEWS CHECK LIST BASICALLY AND I
ACKNOWLEDGE WHAT IT SAYS. WHAT I'M TRYING TO EXPLAIN IS THAT IS FOR PURPOSES OF
SUBSTANTIAL KIND OF LENS, EVERY FINDING HERE IS TERMED SUBSTANTIAL KIND OF LENS
BECAUSE LOOK I'M NOT GOING TO SAY THAT THE FDA DOESN'T SAY THERE'S SOME BACKGROUND
SAFETY PURPOSE TO SAY IT'S AS SAFE AS SOMETHING ELSE ON THE MARKET. I
DISAGREE THAT THAT ACTUALLY PROTECTS SAFETY AND AGAIN EVEN THE COURTS THAT HAVE A LOUD
THIS IN HAVE SAID IT'S MINIMAL AT BEST AND EVEN SOME COURTS THAT DIDN'T LET
IT IN LIKE THE APPELLATE DIVISION SAID NO SAFETY BASIS AT ALL. OH I'M BEING
GUIDED BY THE COURTS THAT PUT IT ALTOGETHER AND SAY IT'S REALLY NOT ULTIMATELY ABOUT
SAFETY. THOSE TESTS WERE WE GO DONE TO SAY IS THIS ENOUGH LIKE ANOTHER DEVICE THAT'S
ALREADY ON THE MARKET THAT CAN PASS THESE TESTS. NOT THAT IT'S GOING TO BE
WITH SAVE IN THE ACTUAL USE. THERE'S ACTUALLY DISCLAIMERS IN THE
AUTHORIZATION TO SELL THIS IS NOT TO BE TAKEN ANYWHERE BEYOND WHAT IT IS. THIS IS
NOT APPROVAL. THIS IS NOT AN OVERALL FINDING OF ANYTHING OUTSIDE THE CONFINES
OF WHAT WE'VE SAID AND AGAIN, THE TRIAL TURNED STATE LAW CLAIMS WAS WAS THE
DESIGN MEDICALLY SAFE AND EFFECTIVE. WAS THE WARNINGS MEDICALLY SAFE AND
EFFECTIVE. 510(K) DOESN'T AMICI TO SPEAK TO THAT AT ALL. THE HEARD BARD FULLY DEFEND
ON THE BASIS WHAT YOU JUST READ ABOUT. AGAIN WE WERE ABLE TO SHOW NONE OF
THOSE TESTS ACTUALLY SPOKE TO ANY OF THE MEDICAL ISSUES THAT ACTUALLY WERE AT
ISSUE AND THAT ACTUALLY WERE THE PROBLEMS WITH THESE DEVICES. MR. JAO:
THE WHOLE POINT OF 510(K) IS TO SAY YOU HAVE A NEW PRODUCT. WE HAVE THESE IN YOUR
CATEGORY OF PRODUCT WE HAVE ALREADY DECIDED THAT PRODUCTS LIKE THIS ARE SAFE AND
EFFECTIVE. OUR ISSUE IS IS THIS ENOUGH LIKE THAT TO MAKE -- TO SAY IT'S SAFE AND
EFFECTIVE. THAT'S THE WHOLE POINT OF 510(K) RIGHT. ADAM M. SLATER: I
THINK IT'S OVER STATING WHAT WE HAVE HERE. WE DON'T HAVE A FINDING OF SAVE AND
EFFECTIVE BASED ON. MR. JAO: THAT'S BECAUSE YOU'RE SAYING IT'S NOT THE
SURGICAL MESH, IT'S THE WHOLE. IT'S THE PROCESS, IT'S THE ARMS, IT'S THE WAY
IT'S YOUR HONOR VERDICT HAD VAGINAL NOT ABDOMINALLY. ADAM M. SLATER: WHAT
WAS WHAT WE TRIED THE CASE ON THE STATE LAW CLAIMS. THE QUESTION IS WHAT WE'RE
ACTUALLY TRYING. BECAUSE ULTIMATELY YOU TELL A JURY OKAY JUST LETTING YOU
KNOW THIS HAS NOTHING TO DO WITH DECIDING THESE CLAIMS BUT JUST AS A BACKGROUND POINT
WE WANT YOU TO KNOW THIS WAS NOT ILLEGALLY SOLD. WE NEVER SAID THESE PRODUCTS
WERE INLITTLE I. WE SAID THEY WEREN'T UNSAFE. IT'S CONFUSING. NOW THE JURY
IS TELLING YOU TOLD ME IT WOULD SOLD LEGAL HAD I I CAN'T CONSIDER IT. THE
APPELLATE DIVISION TELL THE JURY PRE MARKET APPROVED AND 510(K) IMAGINE HOW COMPLICATED
THAT WOULD BE WE'RE TALKING IT THROUGH AND I HAVE PILES OF PAPER WE'RE NEVER
GOING TO GET TO IT. WHY ARE YOU GOING TO INJECT THAT LEVEL OF COMPLEXITY AND
CONFUSION INTO AN ALREADY COMPLEX TRIAL TRIAL JUDGE HAS ALREADY DEFINING TO THE
STATE LAW. JUSTICE WAINER APTER: WOULDN'T IT BE VERY ODD THAT FDA
CONCLUSION IN A PRODUCT WAS SAFE AND EFFECTIVE WOULD COMPLETELY PRECLUDE ANY
STATE LAW CLAIM AGAINST THAT PRODUCT AT ALL IF THE FINDING COMES WITHIN THE CONTEXT
OF PRE MARKET APPROVAL AND THAT'S FROM THE FDA PRE EVENINGS CLAUSE THAT BASICALLY
SAYS AS LONG AS THE PRODUCT WAS FOUND TO BE SAFE AND EFFECTIVE WITHIN THE CONTEXT
OF PRE MARKET APPROVAL YOU CANNOT BRING TONIGHT TORT CLAIMS AGAINST THAT COURT
UNLESS YOU'RE SAYING THEY LIED TO THE FDA OR FAILED TO COMPLETE THE PRE MARKET APPROVAL
PROCESS IN THE WAY THE FDA FOUND THAT THEY DID. BUT INSTEAD IF THE PRODUCT
IS FOUND TO BE SUBSTANTIALLY EQUIVALENT TO THE FDA HAS PREVIOUSLY FOUND TO BE
SAFE AND EFFECTIVE NOT ONLY WOULD THAT NOT ONLY BE PREEMPTIVE ABOUT THE FDA FINDING
WOULD BE COMPLETELY IRRELEVANT AS A MATTER OF LAW ISN'T THAT VERY ODD. ADAM M.
SLATER: I DON'T THINK SO BECAUSE AGAIN IF YOU LOOK AT THE REGULATIONS PRE MARKET
APPROVAL INCLUDES A MEDICAL RISK BENEFIT. IT INCLUDES CLINICAL STUDIES TO
SHOW THAT IT'S GOING TO BE EFFECTIVE. IT INCLUDES A MUCH MORE BUST REVIEW AND
THAT'S WHY LOHR SAID WHAT IT SAID AND FOUND PREEMPTION CAN APPLY TO PRE MARKET
APPROVAL NOT 510(K). I WOULD SAY IT'S NOT ANNULUS IT'S A RECOGNITION THAT 510(K)
IS HERE IN TERMS OF THE REVIEW AND REMARK APPROVAL IS HERE BASED ON THE
REGULATIONS AND THAT'S THE REALTY THAT ALL OF THE FEDERAL COURTS HAVE AGREED
TO, EVERY JUDGE THAT HAS ALLOWED IT IN HAS AGREED TO IT. JUSTICE WAINER APTER:
BUT LOHR WAS TALKING ABOUT AT LEAST WHEN I WAS READING LOHR WAS TALKING ABOUT
WHEN YOU GET A SUBSTANTIAL KIND OF LENS FINDING TO A DEVICE THAT WAS ON THE
MARKET BEFORE 1976 SO THERE IS NO INQUIRY INTO SAVE AND EFFECTIVE AND ACCORDING
TO LOHR IT TAKES 23 HOURS NO BIG DEAL YOU ACCEPTED IT IN GET IT THE NEXT DAY
BECAUSE YOU'RE THE SAME AS THIS GRANDFATHERED DEVICE. THIS CASE IS NOT
ABOUT A GRANDFATHERED DEVICE. THEIR PREDICATE THEY'RE POINTING IS NOT ARROGANT FATHERED
DEVICE IT WAS A DEVICE THAT WAS FOUND TO BE SAFE AND EFFECTIVE AT SOME POINT.
ADAM M. SLATER: I DON'T THINK THAT DISTINCTION IS OF ANY MATERIAL SIGNIFICANCE
HERE. YOU CAN LOOK AT ALL OF THE CASES \HAD A\WHAT HAVE LITIGATED THE ISSUE IN
THE FEDERAL COURTS WHERE EVERY SINGLE ONE OF THEM HAVE SAID IT DOESN'T MATTER
AND IN FACT THE SAFE MEDICAL DEVICE AMENDMENTS IN 19 INNOCENT BECAUSE THAT'S
REALLY WHERE THIS COMES FROM, THIS CONCEPT HAVE SAID IT CODIFIED PRIOR PRACTICES
ANYWAY. AND AGAIN WE'RE THROWING THE WORD SAFE AND EFFECTIVE AROUND BUT AGAIN
YOU GET A FINDING OF SAFETY AND EFFECTIVE YOU CAN GET APPROVED FOR PRE MARKET
APPROVALS. IT'S ACTUALLY A VIOLATION OF THE FEDERAL LAW AND CONSTITUTES MISBRANDING
TO DESCRIBE ONE THESE PRODUCTS AS SAFE AND EFFECT I HAVE BASED ON APPROVAL.
THERE'S SO DIFFERENT -- MR. JAO: WHAT IT PROHIBITS IS SAYING YOU HAVE FDA
ABRISTLE. IT DOESN'T PROHIBIT YOU FROM MARKETING AS A SAFE EFFECTIVE. ADAM
M. SLATER: YOU'RE RIGHT THIS THERE IS THAT ONE CASE. I DIDN'T MEAN TO SUGGEST YOU
CAN'T SAY SAVE EFFECTIVENESS REGULATORY. MR. JAO: WHY IS THAT, IS THAT
APPROVAL. CLEARLY BARD COULD NOT SELL THIS PRODUCT WITHOUT THE FDA SIGN OFF,
RIGHT. ADAM M. SLATER: CORRECT. MR. JAO: SO WHAT DOES APPROVAL MEAN
IN THAT REGULAR. ADAM M. SLATER: I'M SORRY IN THE SUBSTANCE KIND OF
LENS IT DOESN'T ACTUALLY APPEAR IT'S CLEARANCE. MR. JAO: BUT THE REGULAR
YOU WERE JUST QUOTING TO ME IT'S 21CFR SECTION 80797, RIGHT? AND THAT REGULAR
SAYS. ADAM M. SLATER: I'M TRYING TO FIND IT IN MY PILE HERE BUT TO
PARAPHRASE IT WHILE YOU'RE LOOKING I THINK THAT WHAT IT'S TALKING ABOUT IS IT'S
PROVED SAFE APPEAR EFFECTIVE BECAUSE THEY DO A MEDICAL RISK BENEFIT, THEY DO CLINICAL
STUDIES TO ACTUALLY PROVE THAT IT IS SAFE AND EFFECTIVE, THE PARTICULAR DEVICE
IN QUESTION AS OPPOSED TO SAYING THIS FITS INTO A CATEGORY SO WE'RE GOING TO
LET YOU SELL IT BUT WE'RE NOT GOING TO EVALUATE IT FOR SAFETY AND
EFFECTIVENESS. MR. JAO: I THINK WHAT IT SAYS A SUBMISSION OF PRE MARKET
NOTIFICATION IN ACCORDANCE WITH THIS SUB PART AND A SUBSEQUENT DETERMINATION
BY THE COMMISSIONER THAT THE DEVICE INTENDED FOR INTRODUCTION INTO COMMERCIAL
DISTRIBUTION IS SUBSTANTIALLY EQUIVALENT TO A DEVICE IN COMMERCIAL DISTRIBUTION
BEFORE MAY 28, 1976 OR A SUBSTANTIALLY EQUIVALENT TO A DEVICE INTRODUCED INTO
COMMERCIAL DISTRIBUTION AFTER MAY 28, 1976 THAT HAS SUBSEQUENTLY BEEN RECLASSIFIED
HAD INTO A CLASS ONE OR TWO DOES NOT IN ANY WAY DENOTE OFFICIAL APPROVAL OF THE
DEVICE. ANY REPRESENTATION THAT CREATES AN IMPRESSION OF OFFICIAL APPROVAL
OF A DEVICE BECAUSE OF COMPLYING WITH THE PRE MARKET NOTIFICATION REGULATIONS
IS MISLEADING AND CONSTITUTES MISBRANDING, THAT'S WHAT WE'RE TALKING ABOUT.
ADAM M. SLATER: I THINK THAT'S WHAT -- I BELIEVE SO. MR. JAO: WHAT DOES
APPROVAL MEAN THERE, DOES IT MEAN PRE MARKET APPROVAL AS IN WHAT YOU WOULD HAVE
TO GO THROUGH IF THERE WERE CLASSIFIED AS IT PANDEMIC NOW IS A CLASS THREE DEVICE
OR DOES IT MEAN WHAT WE WOULD THINK OF AS PROOF WHICH IS YOU CAN'T SELL THIS DEVICE
WITHOUT THE FDA'S SIGN OFF. ADAM M. SLATER: I THINK WE HAVE TO TAKE THE
TERMS AS TERMS OF ART UNDER THE STATUTE. I WISH I HAD THE LANGUAGE RIGHT IN FRONT
OF ME. I'M GRASPING FOR IT WHICH I KNOW I HAVE IT. JUSTICE PIERRE-LOUIS:
THIS PARTICULAR PORTION OF THE CFR DOESN'T EXPLICIT DENOTE WHAT APPROVAL MEANS
BUT WHAT IT DOES SAY IS A DETERMINATION THAT A DEVICE IS SUBSTANTIALLY EQUIVALENT
SHOULD NOT BE REPRESENTED AS APPROVAL. ADAM M. SLATER: CORRECT. CORRECT.
I FOUND IT BUT THANK YOU. ONE STEP TOO LATE I FOUND IT. JUSTICE
PIERRE-LOUIS: EVEN THOUGH WE DON'T HAVE A SPECIFIC DEFINITION HERE WHAT APPROVAL
MEANS. WE KNOW THIS CFR IS DETERMINED TO BE SUBSTANTIALLY EQUIVALENT TO A DEVICE
THAT IS ALREADY IN THE MARKET THAT SHOULD NOT BE REPRESENTED AS APPROVAL BY
THE FDA. ADAM M. SLATER: APPROVAL IS A TERM OF ART. I'LL CERTAINLY SPEAK
TO THE OTHER ISSUE THAT WAS RAISE ON THE CROSS PETITION IF NECESSARY BUT THAT'S
OBVIOUSLY THE REASON WHY -- ONE OF THE REASONS WITH AN THE PLA PUNITIVE DAMAGES
PROVISION DOESN'T MY YOU CAN'T CALL THESE PRODUCTS APPROVED THEY DIDN'T GO THROUGH
THE APPROVAL. THAT CAN'T BE AN APPLIED WHICH AGAIN ARE THE TERMS OF ART THAT DO
NOT APPLY HERE AND I'LL ONLY GO INTO THAT IF I GET AN INDICATION FROM THE COURT
THAT IT'S NECESSARY OTHERWISE I'LL CONTINUE TO FOCUS ON 510(K). CHIEF
JUSTICE RABNER: SINCE WE'RE A LITTLE BIT BEYOND THE HALF HOUR ALREADY WHY DON'T
WE ADDRESS A LITTLE BIT OF PUNITIVE DAMAGES QUESTIONS AS WELL. IS THE ANALYSIS
THE I BALANCING S TAPE. ADAM M. SLATER: THE BALANCING IS EXACTLY THE
SAME. THAT WAS ACTUALLY FOUND IN THE INSTANT CASE WHAT WAS THE 510(K) AVAULTA PLUS
RATHER THAN THE SOLO BUT THEY WERE CLEARED UNDER THE SAME 510(K) AND THE FOURTH
CIRCUIT COURT OF THE APPEALS IN THE CASE AGAINST BARD FOUND THERE'S NO
DIFFERENCE. THE TRIAL COURT FOUND THERE'S NO DIFFERENCE. IN THE KEISER CASE
IN THE SEVEN CIRCUIT THEY FOUND THERE'S NO DIFFERENCE. IT'S EXACTLY THE SAME ANALYSIS
AND THERE'S NO DIFFERENCE. WHAT THE ARGUMENT IS WELL THIS IS A HEIGHTENED
STATE OF MIND WOULDN'T IT LET THE JURY KNOW THEY'VE COMPLIED WITH THE FEDERAL
REGULATION TO SELL IT. THE A GAME COURT TALKS ABOUT WHAT IS 510(K). JUSTICE
SOLOMON: WHY ISN'T THAT RELEVANT STATE OF MIND OF THE MANUFACTURER THAT'S PUTTING
IT INTO THE MARKET. ADAM M. SLATER: IT'S NOT RELEVANT TO THE STATE OF MIND
AND THE PUNITIVE DAMAGE ACT IS VERY CLEAR. IT'S THE ACTUAL OMISSION THAT IS LED
TO THE HARM. THE ACTUAL OPENINGSES THAT ARE IN TRIAL AREN'T DIFFERENT ON A COMPENSATORY
FACE ERA PUNITIVE FACE STILL LACK OF ADEQUATE DESIGN LACK OF ADEQUATE
WARNINGS AND AGAIN, THE FACT THAT THEY SOLD THIS UNDER 510(K) DOESN'T CHANGE
THE FACT THAT THE ACTS OR OPENINGSES AT ISSUE ARE ONLY THE FAIL LOOK YOU ARE FAILURE
TO WARN AND THING HOW THAT WOULD MESSY THAT WOULD BE BIFURCATED TRIAL. BY THE
WAY NOW WE'RE GOING TO LET YOU KNOW THIS FIRE CRACKER MIGHT GO OFF THERE'S
THIS ISSUE AND WE'RE GOING TO TELL YOU ABOUT THIS AT THIS STAGE EVEN MORE PREJUDICIAL
AND MORE CONFUSING AGAIN THE ISSUE EXACTLY THE SAME THE TRIAL COURT WAS EXACTLY
RIGHT TO MAKE THAT FINDING. CHIEF JUSTICE RABNER: WHAT'S THE IMPORT OF
THE NORTH CAROLINA STATUTE SINCE WE'RE APPLYING NORTH CAROLINA LAW. IT SPEAKS TO
JURIES BEING ABLE TO CONSIDER FACTORS THAT INCLUDE DESIGN OR FORMULATION CONFORMED
TO ANY MILKABLE GOVERNMENT STANDARD. WHY DOESN'T THAT INCLUDE THE 510(K) PROCESS.
ADAM M. SLATER: FOR THE REASONS STATED BY THE TRIAL JUDGE. FOR THE REASONS
STATE BAD I THE APPELLATE DIVISION. FOR THE REASONS STATED BY THE JUDGE IN THE
WINE BARRING EROSION RATES CASE IN THE AND BY THE MDL JUDGE. ANY GOVERNMENT
STANDARD HATS REFERRED TO IN THIS STATUTE IS A SAFETY REGULATION AND THEY FOUND
EVERY COURT THAT THAT'S LOOKED AT THIS INCLUDING THE NORTH CAROLINA JUDGE IN
BUYING GOING EROSION RATES SAID THAT IS NOT A STANDARD OF CARE IT'S NOT A SAFETY
TO DO 510(K) ANTAEAN FIT THAT DEFINITION AGAIN EVEN A JUDGE THAT RULED I THINK
MAYBE WE CAN LET THIS IN LIMITING INSTRUCTION. EVERY COURT AGREES AND BECAUSE
IT'S NOT A SAFETY REGULATION OR STANDARD IT'S NOT RELEVANT AND AGAIN, THE STATUTE
SAYS THAT ALL OF THE ELEMENTS NEED NOT BE CHARGED AND IT'S SIMILAR AS YOUR HONOR
SAW IT'S SIMILAR TO OUR RISK UTILITY TEST AND WHICH ALL DO NOT HAVE TO BE CHARGED
EITHER DEPENDING ON THE PROOFS OF THE CASE. SO THAT'S COMPLETELY INAPPLICABLE HERE
AND IT WAS CORRECT NOT TO CHARGE UNDER THAT STATUTE. MR. JAO: BUT THE
FEDERAL DISTRICT COURT IN THAT CASE SAID IT DOESN'T NEED TO BE LIMITED. IT'S
A GOVERNMENT STANDARD UNDER NORTH CAROLINA LAW. ADAM M. SLATER: THAT'S
NOT WHAT THE CASE SAID WITH ALL DUE RAILROAD. WHAT THE COURT SAID WE AGREE
OR I AGREE THAT IT IS NOT A GOVERNMENT STANDARD. IT'S NOT A STANDARD OF CARE
I THINK IT MAKES SENSE TO LET THE JURY HERE AND I'LL GIVE A VERY STRONG LIMITING
INSTRUCTION. IT'S REALLY MORE OF A FEEL KIND OF THING TO SAY WELL LET'S LET
THE JURY KNOW HOW THIS GOT THERE. IT'S NOT THAT BIG A DEAL. BUT I THINK THAT
THAT AND I THINK THE TRIAL COURT RECOGNIZED THERE WAS A LITTLE BIT OF A LACK
OF DEP OF ANALYSIS IN THAT CASE BECAUSE THE COURT MADE ALL THESE FINDING ABOUT THE
FACT THAT IT'S NOT SAVED. IT'S NOT A SAFETY STANDARD. IT DOESN'T FIT UNDER
THAT STATUTE. I'M GOING TO NEED A LIMITING INSTRUCTION BUT I THINK I'M GOING
TO LET THE COURT HERE IT ANYWAY WHICH THE TRIAL COURT HERE FOUND TO BE ANOMALOUS
AT WORST IT BECOMES A DISCRETIONARY DECISION AND AT WORST IF REASONABLE MIND ON
DIFFER ON HOW SOMEBODY DECIDES THAT VERY, VERY TIGHT ISSUE I THINK THAT OUR
TRIAL COURTS HAVE TO KNOW THAT THEY'RE NOT GOING TO BE UNDER A MICROSCOPE OR
THEY'RE GOING TO HAVE TO START HOLDING 104 HEARINGS ON EVERY SINGLE CONTESTED ISSUE
I THINK THAT'S A POLICY POINT THAT I THINK THIS COURT HAS ALWAYS FELT TO BE VERY
IMPORTANT. SO I JUST WANT TO MAKE SURE I'M CLEAR ON THAT YOU CAN THE. Q
VERY LOOK HE AGREED WITH THE JUDGE GOODWIN WHICH IS THE MDL JUDGE IT'S NOT A SAFETY STANDARD?
JUSTICE SOLOMON: I HAVE ONE OH QUESTION I HATE TO HARKEN BACK TO SOMETHING
WE DISCUSSED BEFORE BUT I THINK IT'S RELEVANT TO THIS ISSUE TOO. IF THE ONLY
PART OF THE PRODUCT THAT WAS AT ISSUE HERE WAS THE MESH ITSELF WHICH I THINK YOU
ARGUE THAT'S WHAT THE 510(K) PERTAINS TO, NOT THE REST OF THIS PRODUCT THAT YOU ARE
ARGUING AT TRIAL. IF THE ONLY ISSUE WAS ARE THE OPENINGS TOO BIG, ARE THE
OPENINGS TOO SMALL, IF THE ONLY ISSUE WAS THE MEASURE MESH ITSELF, WOULD WE
HAVE A DIFFERENT CASE HERE. WOULD 510(K) HAVE A DIFFERENT APPLICATION HERE.
ADAM M. SLATER: I DON'T THINK SO BECAUSE YOU WILL OF THE POLICY ARGUMENTS AND ALL
OF THE LEGAL ANALYSIS THAT WE BRING IN FROM THIS COURT STILL ARE THERE TO SAY
510(K) SUBSTANTIAL EQUIVALENT NOT SAFETY. I THINK THAT IT WOULD CERTAINLY
BE SOMETHING THAT A COURT WOULD LOOK AT TO SEE IT WAS CLOSER TIED TO THE ISSUES AT
THE TRIAL. JUSTICE SOLOMON: MESH ITSELF MIGHT BE SUBSTANTIAL EQUIVALENT.
FORGET SAFETY FOR A MINUTE. MIGHT BE SUBSTANTIALLY EQUIVALENT. ADAM M.
SLATER: IT CAN FIT THE DEFINITION AND IT FIT THE DEFINITION HERE ACCORDING TO THE
FDA. JUSTICE SOLOMON: YOU'RE ARGUMENT WE'RE NOT PELVIC MESH PER SE
HERE WE'RE TALKING ABOUT A PRODUCT THAT INCLUDES A LOT OF OTHER THINGS THAT
MAKE THIS DING RUSS. ADAM M. SLATER: RIGHT, IT WAS SOLD AS A SYSTEM.
JUSTICE WAINER APTER: IF YOU'RE TALKING ABOUT THE OTHER PARTS OF THE PRODUCT THAT
WERE USED IN THE I AM PLANTATION OF THE DON'T YOU HAVE TO DEAL WITH THE STATUTE
WHICH I THINK IS THE FDA SETTING FORTH SAFETY AND EFFECTIVENESS STANDARDS FOR
HOW SPECIFIC LICE HAD SURGICAL INSTRUMENTATION FOR USE WITH AGAIN LOGICAL
SURGICAL MESH IS USED AND DOESN'T IT MAKE IT SEEM LIKE THE FDA IS UNDERTAKING A SAFETY
AND EFFECTIVENESS ANALYSIS HERE. ADAM M. SLATER: THE INSTRUMENTS ARE
ACTUALLY LOOKED AT COMPLETELY SEPARATELY AND THEY WERE CLASS ONE WHERE GENERAL CONTROLS
WERE FOUND TO BE AT THE LOWEST LEVEL OF PROBATION JUST THE TOOLS. WITHOUT
CONTEXT TO WHERE THEY WERE GOING TO BE USED ABOUT THE FACT THAT IT'S PART OF THE
AVAULTA SO YOU HAVE THEM OVER HERE WHICH YOU GET THE LOWEST LEVEL OF SCRUTINY THEN
YOU HAVE THE MESH HERE WHICH IS 510(K) AND ALL THEY ARE IS THE SLIVER I STEM FOR
A MEDICAL PROCEDURE THIS COMPANY IS NOW SELLING WHICH IS WHAT ACTUALLY WAS
SOLD BY THE COMPANY AND PROMOTED BY THE COMPANY FOR EXAMPLE TO DR. BARBEE WHO
ACTUALLY WENT INTO A TRAINING SESSION. BARD RUNS PROFILE ADORATION THE SALES
REPRESENTATIVES SAY LET US TEACH YOU OUR PROCEDURE WHICH ESSENTIAL COMPETED FOR THE
LIVE AND THE AMERICAN MEDICAL SYSTEMS APPEAR GEE AND PER GEE AND OUR SYSTEM IS
DIFFERENT. IT'S PUT IN DIFFERENTLY. IT AND COURSE DIFFERENTLY. THAT IS WHERE
THE COMPETITION WAS AND AGAIN, SO IT'S NOT THAT THE FDA LOOKED AND SAID WELL THESE
INSTRUMENTS WITH THIS MESH THIS PROCEDURE IS SAFE AND EFFECTIVE PRE MARKET APPROVAL.
NOBODY OF THAT HAPPENED AND AGAIN THE INSTRUMENTS WERE LOOKED AT SEPARATELY
OUT OF CON TOOK. JUSTICE WAINER APTER: SO THIS CLASSIFICATION WHERE
IT SAYS CLASS TWO SPECIAL CONTROLS, THE SPECIAL CONTROLS FOR SPECIALIZED
SURGICAL INSTRUMENTATION FOR USE WITH URETHRA OH AGAIN LOGIC MESH ARE AND THEN IT
SETS FORTH THE SPECIAL CONTROLS, THAT IS NOT RELATED TO A CLASS TWO SAFETY
AND EFFECTIVENESS INQUIRY. ADAM M. SLATER: WELL, TO THE EXTENT THAT A
SURGICAL TOOL WAS CLASSIFIED AS STAGE -- AS A CLASS TWO, THAT'S ACTUALLY NOT THIS
CASE BECAUSE THESE ACTUAL TOOLS WERE CLASS ONE. BUT EVEN IF THE TOOLS WERE
CLASS TOO WE WOULD STILL BE IN A 510(K) SITUATION AND STILL HAVE THE SAME
PROBLEM WHERE AGAIN AND I KNOW I SAID THIS SEVERAL TIMES. THAT'S NOT WHAT THE JURY
WAS CONSIDERING, THE JURY WAS CONSIDERING SAFETY AND EFFECT \ADVERTISE\IS THENESS
AND A MEDICAL RISK BENEFIT WHICH THE WITNESSES FOR THE DEFENSE COULD NOT DENY
AND HAD TO ADMIT THAT'S NOT SOMETHING THAT THEY COULD REALLY ANSWER WITH THE
LITERATURE THEY RELIED ON BECAUSE ALL THE LITERATURE WAS SAYING VERY DANGEROUS,
DON'T USE THESE DEVICES, WE NEED LONG TERM STUDIES. WE NEED MORE DATA. THAT WAS
THEIR OWN STUDIES, I GAVE YOU IN THE RECORD A MAYO CLINIC ARTICLE THAT THEY
DIDN'T CONSIDER BUT MISPARTS SAID HOW DO YOU NOT CONSIDER THIS BUT SAID THESE NEW
KITS, THEY WERE KIDS KITS THAT'S WHAT THEY'RE BEING DISCUSSED BY THE URETHRA
OH GYNECOLOGISTS. SO DANGEROUS WAS THE MAYO CLINIC WERE SEEING CASES ALL OVER
THE COUNTRY. THE PICTURE ARE VERY GABBING AND ARTICLE IS VERY GABBING. THEY SAID
UNTIL THERE IS LEVEL ONE EVIDENCE PROVING SAFETY AND SPORT TO THE OTHER
ALTERNATIVE PROCEDURES THAT EXIST THESE SHOULD NOT BE AVAILABLE FOR WIDESPREAD
MARKETING. I MEAN THAT'S ALL ARGUMENT TO THE JURY AND 510(K) DOESN'T SPEAKER TO
THAT AT ALL AND THAT IS WOULD BE OF THE OUR CROWNING PIECES OF LITERATURE THE
MAYO CLINIC SAYING YOU CAN'T DO WHAT YOU DID. AND THAT CAME OUT BEFORE HER
SURGERY. AND I'LL TELL YOU ANOTHER ISSUE ABOUT THE CLINICAL STUDIES, THE STANDARD
IN NORTH CAROLINA JUST LIKE NEW JERSEY IS WHAT THEY KNEW OR SHOULD HAVE KNOWN
SO WHY WOULD WE NOT TALK ABOUT THE CLINICAL STUD THEY THEY SHOULD HAVE KNOWN
IN THE MEDICAL DEVICE AND THE DRUG INDUSTRY THE WAY YOU NOTE THINGS IS. JUSTICE
SOLOMON: YOU DON'T SAY YOU WOULDN'T TALK ABOUT. THE ONLY ISSUE WE'RE DECIDING
WHETHER THERE IS SOME EVIDENCE OUT THERE IT SHOULD BE AT LEAST CONSIDERED BY THE
JURY IN REACHING IT'S CONSIDERED. NOBODY IS SAYING THAT STUFF DOESN'T COME
IN. THAT STUFF IS NOT RELEVANT. THAT MAY BE ENOUGH FOR THE JURY TO DECIDE
YOU WIN. THE QUESTION WHETHER THIS 510(K) EVIDENCE COMES IN FOR THAT LIMITED
PURPOSE. ADAM M. SLATER: I THINK WHAT I WAS TRYING TO SAY NOT ELOQUENTLY
THAT THE 510(K) DOESN'T ANSWER THAT CLINICAL STUDY ISSUE IN THE TRIAL AND THAT SO
S SUGGESTION BY THE APPELLATE DIVISION THAT WELL YOU TALKED ABOUT CLINICAL STUDIES
BEFORE THE 510(K) DIVISION, THIS IS A VERY IMPORTANT POINT, BEFORE IT EVER HAPPENED,
A YEAR OR MORE HOWEVER LONG BEFORE THE EXPERT REPORTS WERE WRITTEN AND WE TOOK
THE DEPOSITIONS OF THE EXPERT. THESE WISHES WERE ALREADY IN THE CASE. THE
CLINICAL STUDIES ISSUE -- JUSTICE SOLOMON: THAT'S ALL EVIDENCE AND THAT'S
ALL GOING TO THE JURY AND THAT MY PROVE YOUR ENTITLED TO DAMAGES AND PUNITIVE DAMAGES.
THE ONLY QUESTION IS WHETHER IN THAT CONTEXT, IN THAT TRIAL THE JURY SHOULD
HAVE HAD A CHANCE TO HEAR THAT THERE WAS A PROCESS THAT IT DID GO THROUGH TO
GET INTO THE MARKET. THAT'S ALL THAT QUESTION. IT DOESN'T CONCLUDE ANYTHING
ELSE. IT DOESN'T EVEN MEAN THAT EVIDENCE TRUMPS ANYTHING ELSE. ADAM M.
SLATER: I WAS SORT OF ANSWERING THE POINT OF DIFFICULT TAKE ADVANTAGE OF THE RULING
BY TALKING ABOUT CLINICAL STUDS IS, I JUST WANTED TO MAKE THAT NOTION WAS DISABUSED.
JUSTICE SOLOMON: I DON'T THINK THAT IS THE QUESTION TAKING ADVANTAGE OF
CLINICAL STUDIES. THE QUESTION IS WHEN YOU SAY, IF YOU SAY I HAVE TO LOOK
AT THE MOLE TRANSCRIPT AGAIN IF YOU SAY THAT THE FDA NEVER CONSIDERED, THE FDA
NEVER LOOKED AT, THE FDA NEVER THOUGHT OF, THEN YOU MIGHT HAVE A PROBLEM AND THEN
IT MAY COME IN JUST BECAUSE YOU RAISED. ADAM M. SLATER: OF COURSE I STAYED
MILES AWAY FROM THAT. JUSTICE SOLOMON: NO, THAT'S REALLY THE
QUESTION. I. ADAM M. SLATER: I THINK THAT MY BEST RESPONSE TO THAT IS
THERE WE HAD TWO VERY ISSUES AT TRIAL. THE DESIGN TO CLAIM AND FAILURE TO WARN
TO CLAIM. TOOK A MONTH TO TRY THE CASE SOPHISTICATED LAW FIRMS ON THE DEFENSE
SIDE LOT OF EXPERT. IF YOU INJECT 510(K) INTO THIS TRIAL THAT BECOMES THE THIRD MAJOR
ISSUE IN THIS CASE BECAUSE THERE'S NO WAY TO GET AWAY FROM THIS IT. I WILL
TELL FROM YOU MY SPEAKER EQUITY THE IDEA OF A LIMITING INSTRUCTION WOULD BE
DEVASTATING, IF IT COMES IN YOU HAVE TO HAVE A MINI TRIAL ON IT BECAUSE IT'S SO
PREJUDICIAL TO TELL A JURY THAT THE FDA ALLOWED IT TO BE SOLD NOW THE JURY HAS
TO UNDERSTAND NOW EAR THEY'RE HEARING PROOFS ON BOTH SIDES A AND YOU'VE ELEVATED
THE ISSUE TO A LITIGATED ISSUES. JUSTICE SOLOMON: LET ME TELL YOU
SOMETHING I SHOULD REALLY STOP HERE. THE FDA SAID THE MEASURE CAN BE SOLD, THE FDA
NEVER SAID AT LEAST I THINK YOUR ARGUMENT IS THAT THIS PRODUCT CAN BE SOLD
THAT'S WHY 510(K) NOT RELEVANT. ADAM M. SLATER: THE FDA NEVER LOOKED AT
THE PROCEDURE NEVER DID A MEDICAL PROSECUTOR. JUSTICE WAINER APTER: BUT
THE FDA NEVER AUTHORIZED THE PRODUCT. I THOUGHT THE FDA HAD AUTHORIZED THE
PRODUCT. ADAM M. SLATER: NO WHAT I'M SAYING IS THE FDA DIDN'T CONSIDER
THE PROCEDURE, THEY DIDN'T CONSIDER THE MEDICAL RISKS AND BENEFITS, THEY DIDN'T
LOOK AT HOW IS THIS GOING INTO THE BODY HOW IS GOING TRACHEARIA I MIGHT DISAGREE
WITH THE FDA ANALYSIS THEY DID AT THE END OF THE DAY SEND SOME SORT OF OR.
ADAM M. SLATER: I'M NOT DISAGREES WITH HIM FDA HANDLE. WHAT I'M SAYING THE ANALYSIS
RAILROAD COURT LOOKED AT THIS INCLUDING THOSE THAT LET IT IN IS THE ANALYSIS
IS SO MINISCULE AND EVEN THE COURTS THAT LET I IN HAVE ACKNOWLEDGED THE CONFUSION
AND PREJUDICE IT WOULD INJECT. I'M NOT SAYS THE FDA IS WRONG. I'M NOT SAYING
THEY DIDN'T CONSIDER WHAT THEY CONSIDERED BUT THEY DIDN'T CONSIDER THE ISSUES THAT
WE WERE GOING TO TRY THE CASE CASE ON AND I THINK THAT THE BETTER PRACTICE IS IF A TRIAL
JUDGE LOOKS AT ALL OF THIS AND SAYS LOOK I KNOW THIS CASE I KNOW HOW IT'S GOING
TO BE TRIED I'M GOING TO KEEP THE ISSUES CONFINED NOT ONLY KEEP OUT 510(K)
BUT THE SIMPLY SIDE OF THE COULD YOU BE THAT THEY STOPPED SELLING THESE PRODUCTS
AND WHY THEY STOPPED SELLING THESE PRODUCTS. WE'RE NOT GOING TO TRY THE CASE
ON THAT EITHER. WE'RE GOING TO FOCUS ON THE STATE CLAIM I OBJECT AND WE'RE
NOT GOING TO HAVE THE OTHER SIDE SHOWS BECAUSE THE CASE IS ALREADY TOUGH ENOUGH
I THINK WE HAVE TO TRUST. CHIEF JUSTICE RABNER: LET'S PAUSE TORE A SECOND.
ANYTHING YOU LIKE TO ADD WE'LL HAVE YOU BACK FOR REBUTTAL, OF COURSE.
MR. PHRAS. JARED M. PLACITELLA: GOOD MORNING YOUR HONORS, THANK YOU FOR
PERMITTING NJ A J FOR THE OPPORTUNITY TO APPEAR AND ARGUE TODAY BEFORE THE
COURT. THE 510(K) PATHWAY DOES NOT EVALUATE A SPECIFIC MEDICAL DEVICE IS SAFETY
OR EFFICACY. IS THEREFORE, IRRELEVANT AND INADMISSIBLE TO A DESIGN OR WARNING
DEFECT CLAIM UNDER THE NEW JERSEY PRODUCT LIABILITY ACT OR A CLAIM FOR PUNITIVE
DAMAGES UNDER NEW JERSEY LAW. THE APPELLATE DIVISION HERE WRONGLY SUBSTITUTED
ITS JUDGMENT FOR THAT OF THE TRIAL JUDGE WHO CAREFULLY CONSIDERED THE FACTUAL
RECORD AND CAME TO THE CORRECT DECISION WHICH WAS CONSISTENT WITH EVERY COURT OF
APPEALS THAT HAS CONSIDERED THIS ISSUE. AND THOSE APPELLATE COURTS HAVE EXPLAINED
THAT TO PERMIT 510(K) EVIDENCE WOULD CREATE AN EXTENSIVE MINI TRIAL IRRELEVANT
TO THE CENTRAL QUESTIONS POSED BEFORE THIS COURT. WHETHER THE DEVICE AT ISSUE WAS
DEFECTIVELY DESIGNED, CONTAINED A WARNING DEFECT OR WHETHER PUNITIVE DAMAGES
WERE WARRANTED. 510(K) CLEARANCE IS IRRELEVANT TO A DESIGN DEFECT CLAIM
UNDER THE NEW JERSEY PRODUCT LIABILITY ACT. BOOBIES THE PRODUCTS LIABILITY ABILITY
FOCUSES ON THE FOLKS ON THE FOLK ON THE PRODUCT ITSELF. THE ACT REQUIRES THAT THE
JURY DO A RISK UTILITY ANALYSIS TO DETERMINE WHETHER THE PRODUCT IS DEFECTIVELY
DESIGNED AND THUS, IF THE MANUFACTURER ACTED REASONABLY IN MARKETING THE PRODUCT.
MR. JAO: DIDN'T INSTANCE, ISN'T THE SUBSTANCE CONTROLLED BY NORTH CAROLINA
LAW. JARED M. PLACITELLA: THE SUBSTANCE IN THIS CASE IS CONTROLLED BY
NORTH CAROLINA LAW. THE SEPTEMBER IT MAY BE RELEVANT AND THIS COURT WOULD LIKE TO
PROVIDE GUIDANCE, THE NEW JERSEY COURTS HOW TO ADDRESS THIS ISSUE MOVING FORWARD
WE ADDRESS NEW JERSEY LAW IN LIGHT OF AQUATAIN WHICH IS AFTER EVERY CASE OF
THIS ONE IS NEW JERSEY LAW. SO THEREFORE, ANOTHER IMPORTANT TO RECOGNIZE HOW
NEW JERSEY LAW HANDLES 510(K). THE RISK UTILITY ANALYSIS THAT INVOLVES A
SEVERANCE FACTOR TEST IN THE UNDER PRODUCT ABILITY AND NOTABLY COMPLIANCE WITH ANY
FEDERAL LEG LEGISLATION INCLUDING 510(K) IS NOT PART OF THOSE FACTORS. AND
THAT MAKES SENSE BECAUSE AS THE APPELLATE DIVISION HERE AND THE SUPREME COURT
IN REGAL EXPLAINED THE 510(K) CLEARANCE PROCESS DOES NOT REQUIRE A DEVICE TO TAKE
ANY PARTICULAR FORM FOR ANY PARTICULAR REASON. 510(K) IS ALSO IRRELEVANT TO
A WARNING'S DEFECT CLAIM UNDER NEW JERSEY LAW. BECAUSE AS THIS COURT HAS
EXPLAINED MULTIPLE TIMES SAFETY IS THE PREDOMINANT FACTOR IN DETERMINATION THE
ADEQUACY OR REASONABLENESS OF A MANUFACTURERS EFFORTS IN A WARNING DEFECT CLAIM.
THE REASONABLENESS OF A MANUFACTURER THAT THE JURY IS TASKED TO EVALUATE IN A
WARNING DEFECT CLAIM IS THE MANUFACTURERS DECISIONS OF WHETHER AND HOW TO WARN,
NOT WHETHER TO -- WHETHER IT WAS REASONABLE TO SUBJECT ITS DEVICE TO A SUBSTANTIAL
KIND OF LENS TEST. AND TO GO BACK ON THE DISCUSSION THAT YOU HAD WITH MR. SLATER
IS THAT UNDER OUR LAW AS STATE MEDICAL DEVICES WEEK EROSION RATES, FELDMAN
AND O'BRYAN, THIS COURT HAS EMPHASIZED THAT WHETHER A PRODUCT IS DEFECTIVE MUST
FOCUS ON THE SPECIFIC PRODUCT AT ISSUE. AND IT REJECTED -- YOU REJECTED A
CATEGORICAL APPROACH TO SAFETY. BUT THE 510(K) PATHWAY ONLY FOLLOWS THAT REJECTED
APPROACH. ACCORDING TO THE UNITED STATES SUPREME COURT IN REGAL 510(K) DOES NOT
EVALUATE IF THE SPECIFIC WARNINGS COMMUNICATE ADEQUATE INFORMATION ABOUT
THE DANGERS AND SAVE USE OF THE INDIVIDUAL MARKETED DEVICE AND IT DOES NOT REQUIRE
A SPECIFIC LABELING REQUIREMENT FOR THE INDIVIDUAL DEVICE. 510(K) ASKS ONLY
WHETHER THE MEDICAL DEVICE FALLS WITHIN THE SAME -- THE CATEGORY AS THE PREDICATE
DEVICE, NOT WHETHER THE SPECIFIC PRODUCT DEVICE THAT'S MARKETED AT ISSUE IS
SAFE. 510(K) CLEARANCE IS ALSO IRRELEVANT TO PUNITIVE DAMAGES UNDER THE
PUNITIVE DAMAGES ACT. JUSTICE WAINER APTER: BACK TO LIABILITY FOR
ONE SECOND. I THOUGHT YOU HAD STATED IN YOUR BRIEF FDA EVIDENCE COULD BE RELEVANT
TO A STRICT LIABILITY TORT CLAIM ONLY IF IT WAS ABOUT SAFETY AND EFFECTIVENESS
AND ONLY PRE MARKET APPROVAL IS ABOUT SAFETY AND EFFECTIVENESS NOT 510(K).
BUT I THOUGHT UNDER LOHR AND REGAL ALL THE STATE COMMON LAW CLAIMS ARE PRE-EMPTED
IF THE DEVICE APPROVED REMARK APPROVAL. I WASN'T SURE WHEN A FDA PRE MARKET
APPROVAL OF SAFETY AND EFFECTIVENESS EVER BE RELEVANT TO A STATE LAW CLAIMS IF ALLSTATE
LAW CLAIMS ARE PRE-EMPTED IF YOU HAVE SUCH A CLAIM. JARED M. PLACITELLA:
IT WOULD BE PRE-EMPTED BUT THE PUNITIVE DAMAGES PRODUCTS LIABILITY ABILITY IF A
DEVICE IS PRESCRIBED OR APPROVED. THAT IS NOT 510(K). 510(K) -- MARKET --
DEVICES THAT WERE APPROVED ARE ONLY THOSE THAT ARE PASSED PRE MARKET APPROVAL. AND
THAT'S BECAUSE AS WE DISCUSSED EARLIER IT WOULD BE CRIMINAL MISBRANDING FOR
A MANUFACTURER TO SAY THAT ITS DEVICE WAS APPROVED WHEN ONLY IT PASSED 510(K).
WARNINGS THAT PASS 510(K) ARE NOT PRESCRIBED UNDER THE PRODUCT LIABILITY ACT
BECAUSE AS THE SUPREME COURT EXPLAINED IN REGAL ONLY THE PRE MARKET APPROVAL IMPOSES
WARNING REQUIREMENTS TO SPECIFIC PRODUCTS TO ENSURE THAT THE PRODUCT IS SAFE AND
EFFECTIVE, 510(K) CLEARANCE DOES NOT. TURNING TO PUNITIVE DAMAGES 510(K)
DAMAGES IS ALSO RELEVANT TO PUNITIVE DAMAGES BECAUSE AS THE APPELLATE DIVISION
CORRECTLY RECOGNIZED 510(K) CLEARANCE IS NOT ONE OF SUBSTANTIVE PRE MARKET
APPROVAL OR LICENSURE AND DOES NOT SIGNIFY THE FDA HAS FOUND THAT THE DEVICE TO BE
SAFE AND EFFECTIVE SO IT DOES NOT FALL BY THE CLEAR TEXT OF THE STATUTE DOES NOT
FALL WITHIN THE ABSOLUTE DEFENSE TO PUNITIVE DAMAGES. AND GIVEN THAT THE YOUR HAS
ADDRESSED PRE MARKET APPROVAL AND LICENSURE BUT NOT 510(K) CLEARANCE SHOWS ITS
INTENT THAT 510(K) IS IRRELEVANT TO PUNITIVE DAMAGES. JUSTICE WAINER APTER:
AGAIN THIS SEEMS TO RUN INTO THE SAME ISSUE AS BEFORE. IF ONLY PRODUCTS THAT
HAVE RECEIVED PRE MARKET APPROVAL CAN FALL INTO THIS PUNITIVE DAMAGES STATUTE BUT
ALL PRODUCTS THAT HAVE REI SEIZED PRE MARKET APPROVAL YOU CANNOT BRING ANY
STATE LAW AGAINST THEM BECAUSE ALLSTATE LAW CLAIMS ARE PRE-EMPTED BY THE FDA'S
REGULATIONS THEN ARE WE JUST SAYING THAT THE NEW JERSEY LAW REACHES ABSOLUTELY
NOTHING BUT IT COULD ONLY REACH CASES -- REACH DEVICES TAKE HAVE RECEIVED PRE
MARKET APPROVAL BUT IF THE DEVICE HAS RECEIVED PRE MARKET APPROVAL THEN ALLSTATE
ARE PRE-EMPTED. JARED M. PLACITELLA: WE HAVE TO LOOK AT THE STATUTE
AND THAT WOULD BE OUR REPUTATION FOR THE PLA. THE PLA FOR PUNITIVE DAMAGES SAYS
THAT THERE'S AN ABSOLUTE DEFENSE TO PRE MARKET APPROVAL LICENSURE AND THOSE
DEVICES -- PRODUCTS HAVE BEEN GENERALLY RECOGNIZED AS SAFE. THAT IS NOT 510(K).
SO IT'S IRRELEVANT BY THE TEXT OF THE CLEAR TEXT OF THE STATUTE TO PUNITIVE
DAMAGES. JUSTICE WAINER APTER: SO THEN THE STATUTE WOULD REACH NOTHING,
NO DEVICES AT LEAST. JARED M. PLACITELLA: WELL IF YOU HAVE REBUTTAL
PRESUMPTION ON THE FAILURE TO WARNING CLAIM AND YOU GET TO PUNITIVE DAMAGES.
PUNITIVE DAMAGES ARE ALLOWABLE. SO I MEAN IF THE CLEAR TEXT OF THE STATUTE IS WHAT
IT IS. AND NOT ONLY IS THE CLEAR TEXT OF THE STATUTE NOT REACH 510(K) CLEARANCE
BUT THE FACT THAT THE MANUFACTURERS DEVICE RECEIVED 510(K) CLEARANCE IS ALSO
IRRELEVANT BECAUSE UNDER THE PUNITIVE DAMAGES ACT THE JURY MUST CONSIDER FOUR
FACTORS IN SIDING WHETHER TO AWARD PUNITIVE DAMAGES. ALL OF THOSE FACTORS ARE BASED
ON THE DEFENDANT'S KNOWLEDGE OF HARM THAT WOULD ARISE PROSECUTE FROM IT'S CONDUCT
AND IT RESPONSE TO THAT KNOWLEDGE. 510(K) CLEARANCE IS IRRELEVANT TO THAT
QUESTION. FINALLY, I'D LIKE TO DISCUSS THE PRACTICAL IMPLICATIONS OF PERMITTING
510(K) EVIDENCE. TO FOLLOW THE APPELLATE DIVISION'S FRAMEWORK WHICH SUBSTANTIALLY
CONFUSED THE ISSUES FOR THE JURY AND CREATE A MINI TRIAL OVER THE EFFICACY OF THE
510(K) PATHWAY, WHAT IT ENTAILS AND WHETHER THE PRESENTED CASE DEVICE WHICH IS NOT
EVEN THE DEVICE AT ISSUE IN THE CASE IS SAFE. THIS COULD EASILY INFLATE THE
PURCHASE SEIZED IMPORTANCE OF 510(K) COMPLIANCE AND DISTRACT THE JURY FROM
THE CENTRAL QUESTIONS THAT IT IS TASKED TO ANSWER. AS THE FOURTH CIRCUIT AS STATED
IN SYSTEM IT EXPRESSED ITS CONCERN THAT POSSIBLY DAYS OF COMPLEX TESTIMONY ABOUT
REGULATORY COMPLIANCE COULD LEAD JURORS TO CONCLUDE THAT REGULATORY COMPLIANCE
PROVED PRODUCT SAFETY. HERE BARD PROFFERED THAT IF THE JURY WERE PERMITTED
TO BE INFORMED ABOUT 510(K) CLEARANCE IT WOULD HAVE CALLED 23 WITNESSES TO
ADDRESS 510(K) IN WHAT WAS ALREADY A FOUR WEEK TRIAL. THEN PRESUMABLY THE
PLAINTIFF COULD BE FORCED TO RESPOND WITH THEIR OWN EXPERT AND WITNESSES SO PRACTICALLY
PERMITTING 510(K) EVIDENCE WOULD UNNECESSARILY AND SUBSTANTIALLY RISK
THAT THE JURY WOULD CONFUSE THE ISSUES AT HAND AND SIGNIFICANTLY PROLONG WHAT ARE
ALREADY COMPLEX TRIALS. MR. JAO: THE TRIAL. Q CAN CONTROL ALL OF THAT,
CAN CONTROL THE NUMBER OF WITNESSES, THE CONTROL THE LENGTH, DO YOU SEE THAT IT'S SOMEWHAT
DIFFICULT TO ARRANGE PREJUDICE PROSECUTE THE SIDE THAT THAT IS GOT A VERY LARGE VERDICT?
MR. JAO: MULTIPLE MILLIONS. JARED M. PLACITELLA: I DON'T SEE THAT
AS THE ISSUE HERE YOUR HONOR. THE ISSUE IS 510(K) ADMISSIBLE IN A CASE THAT
CHANGES THE ENTIRE NATURE, COMPLETION AT THE, PERHAPS OUTCOME OF A TRIAL.
BECAUSE ONCE YOU PUT FDA CLEARANCE, FDA ANYTHING ON THE TABLE, THAT CHANGES THE
BALANCE SO MUCH. MR. JAO: AREN'T YOU MAKING THEIR ARGUMENT. THAT'S.
THE JURY SHOULD CONSIDER. JARED M. PLACITELLA: I'M NOT MAKING THAT
ARGUMENT, YOUR HONOR, I'M SAYING THAT IT WOULD -- ANY TANGENTIAL ALLSTATE LAW
RELEVANCE WHICH WE SUBMIT THERE ARE NONE BECAUSE THE EVIDENCE OF 510(K) CLEARANCE
STILL NEEDS TO BE RELEVANT TO A PARTICULAR CLAIM OR TIED TO AN ISSUE, IN THIS CASE
IT'S NOT. ANY POTENTIAL RELEVANCE IF YOU WERE TO FIND SOME IS SO STANCHION
ALL OUT WADE BY THE DANGER OF UNDUE PREJUDICE THAT THE IMPROMPTU OF FDA CLEARANCE
APPROVAL WOULD WEIGH ON THE JURY WOULD TILT AGAINST IT BEING DISMISSIBLE. A LIMITED)
CANNOT CURE THAT PREJUDICE. CHIEF JUSTICE RABNER: WHAT IF A COURT WERE
TO DETERMINE IF RELEVANT JUST TO THE PUNITIVE DAMAGES SAYS IS THE SAME.
JARED M. PLACITELLA: IT IS, YOUR HONOR, BECAUSE THE -- ONCE FDA APPROVAL IS ON THE
TABLE IT EXCUSE THE JURY'S PERSPECTIVE INTO SAYING THAT THE FDA FOUND THAT
THIS DEVICE WAS SAFE. BUT TO PUNITIVE DAMAGES, THAT'S IRRELEVANT BECAUSE THE
PUNITIVE DAMAGES ASK ONLY THE FOUR FACTORS AND THE PUNITIVE DAMAGES ACT IS
WHAT WAS THE DEFENDANT'S ACKNOWLEDGE AND WHAT WAS HIS RESPONSE TO KNOWLEDGE. ONCE
FDA CLEARANCE IS INJECTED INTO THAT QUESTION IT EXCUSE AWAY FROM THOSE ISSUES.
JUSTICE WAINER APTER: I CAN'T TELL IF THE JURY WOULD NOT FOLLOW STUCKS
FROM THE JUDGE EXPLAINING THIS IS NOT DETERMINATIVE OF THE CASE AND THIS IS
NOT A FINDING THAT IS THE SAME AS A PRE MARKET APPROVAL FINDING, IS THAT YOUR
ARGUMENT OR IS YOUR ARGUMENT THAT THE FDA APPROVAL ACTUALLY IS OR EVEN THE FDA 510(K)
IS ACTUALLY SUPERIOR -P SO THE JURY WOULD PROPERLY CONSIDER THAT IT IS.
JARED M. PLACITELLA: MY ARGUMENT IS KIND OF BOTH. IT'S THAT FDA CLEARANCE TO TAKE
SUCH A WEIGHT THAT IT WOULD DISTRACT THE JURY FROM CONSIDERING THE TRUE ISSUES
THAT IS BEFORE THE COURT. AND BEFORE THE COURT ARE ISSUES RELATED TO WARRANT
DEFECT, DESIGN DIRECT AND PUNITIVE DAMAGES. NOTHING OF THE ELEMENTS OF THOSE CLAIMS
FIT WITH 510(K) CLEARANCE. SO ONCE YOU INJECT 510(K) CLEARANCE IT TAKES ON A WHOLE
NEW IMPORTANCE THAT IS REALLY IRRELEVANT TO THE CLAIMS AT ISSUE. JUSTICE
WAINER APTER: BUT AT TRIAL THERE WAS A DISCUSSION A LOT OF THE UNDERLYING EVEN
IF THERE WAS NO MENTION OF THE 510(K) CLEARANCE PROCESS IT SEEMS LIKE THERE WAS A
DISCUSSION YOUR FRIEND MENTIONED ABOUT A LOT OF THE EVIDENCE THAT WENT INTO THE
510(K) CLEARANCE REVIEW OR THE 510(K) EVEN THEIR ORDER I THINK WHAT WAS
SPECIFICALLY MENTIONED IN THE FDA ORDER I THINK YOUR FRIEND WAS SAYING WAS PART OF
THE TRIAL. SO THE JURY HEARD ALL OF THAT. BUT YOU THINK THE FACT THAT THE FDA ANY
PROCESS WOULD BE SO PREJUDICIAL DOESN'T THAT ITSELF MEAN THAT THE PROCESS WAS
RELEVANT TO THE CASE. JARED M. PLACITELLA: IT DOESN'T BECAUSE 510(K),
THE SUPREME COURT HAS SAID IN EAGLE AND THE FOURTH CIRCUIT. THE SIX CIRCUIT. EVERY
APPELLATE COURT \HAD A\WHAT HAS CONSIDERED THE ISSUE HAS SAID THAT 510(K) DOES NOT
GO TO SAFETY. IF 510(K) -- JUSTICE WAINER APTER: AGAIN REGAL CONSIDERED
THE 510(K) PROCEEDS TO A PRE 19 FIX PRODUCT NOT TO A PRODUCT THAT WAS HELD TO BE
SAFE AND EFFECTIVE. JARED M. PLACITELLA: WELL, THE FOURTH CIRCUIT,
THE SIX CIRCUIT, THE 11 CIRCUIT HAVE ALL FOUND THAT 510(K) CLEARANCE INCLUDING THOSE
COURTS ARE CONSIDERED PRODUCTS THAT ARE THE ONES AT ISSUE OR VERY SIMILAR IS NOT
RELEVANT TO SAFETY. THIS WOULD BE THE FIRST APPELLATE COURT TO FIND SO. SO BECAUSE
510(K) CLEARANCE DOES NOT DO TO SAVE AND ONLY GOES TO SUBSTANTIAL KIND OF LENS
ITS IRRELEVANT TO THE QUESTIONS THAT THE JURY NEEDS TO ANSWER. CHIEF JUSTICE
RABNER: THANK YOU MR. MRS.. JARED M. PLACITELLA: TURN. WITH
DAVID R. KOTT: THE COURT: RE. DAVID R.
KOTT: IN BOTH NEW JERSEY AND IN NORTH CAROLINA, THE STANDARD FOR DEFECT IN A
PRODUCT LIABILITY CASE IS WHETHER THE MANUFACTURER ACTED REASONABLY IN
DESIGNING THE CASE AND IN FORMULATING THE WARNING. IN THIS CASE,
THE PARTIES STIPULATED, AS CHIEF JUSTICE HAS NOTED THAT ON THE PRODUCT LIENLT CASE,
THE NORTH CAROLINA STATUTE WOULD APPLY. AND THAT NORTH CAROLINA PRODUCT
LIABILITY STATUTE EXPRESSLY INCORPORATES THE STANDARD I JUST GAVE, WHETHER THE
MANUFACTURER ACTED REASONABLE PLEA IN DESIGNING THE PRODUCT APPEND IN
FORMULATING THE WARNINGINGS, BUT THE NORTH CAROLINA STATUTE GOES FURTHER AND IT
SAYS -- IT LISTS A NUMBER OF RISK UTILITY FACTORS AND IT SAYS THE TRIAL
COURT SHALL, SHALL IS THE VERB, INSTRUCT THE JURY ON AND THEN IT LISTS THE RISK
UTILITY FACTORS AND IT SAYS ANY, ANY GOVERNMENT STANDARD.
THERE IS ONLY ONE NORTH CAROLINA DECISION AND THAT'S WOOIN BERGENER. IT'S A PELVIC
MESH PRODUCT LIABILITY CASE. IT'S DIRECTLY ON POINT AND IT HOLDS THAT
510(K) EVIDENCE IS ADMISSIBLE UNDER THE NORTH CAROLINA STATUTE. I
AM GOING TO DROP A FOOTNOTE, JUST LIKE THIS COURT ON THREE OCCASIONS FELD MAN,
KEND DAL AND PEREZ HAS SAID FDA EVIDENCE IS ADMISSIBLE IN A DRUG AND DEVICE
CASE. AT TRIAL, ON 23 OCCASIONS, THE PLAINTIFF'S LAWYER
REFERRED TO THE LACK OF CLINICAL TRIALS. HE SAID CLINICAL TRIALS WERE NECESSARY
AND REQUIRED. HE EVEN SAID THAT BECAUSE THESE PRODUCTS WERE NOT SUBJECT TO
CLINICAL TRIALS THAT THEY WERE EXPERIMENTAL AND BARD'S HAND AT TRIAL WERE TIED.
BARD COULD NOT TELL THE JURY THAT UNDER THE FEDERAL STATUTES
IT HAD TO USE THE 510(K) PROCESS. IT COULD NOT USE THE PREMARKET APPROVAL PROCESS.
BARD COULD NOT TELL THE JURY THAT IT WENT TO THE FDA AND ASKED
FOR PERMISSION TO SELL THE PRODUCTS. THE FDA GAVE IT PERMISSION AND IN DOING SO
SAID TO BARD, BUT YOU MUST CHANGE THE WARNINGS AND BARD DID THAT.
MOST SIGNIFICANTLY, BARD COULD NOT TELL THE JURY THAT THE FDA SPECIFICALLY CONCLUDED
THAT NO CLINICAL TRIALS WERE REQUIRED. AND AS JUDGE SABATINO NOTED IN THE
APPELLATE DIVISION DECISION, THIS LEFT THE JURY WITH A FALSE IMPRESSION THAT THERE WAS
NO REGULATORY OVERSIGHT AT ALL OF THESE PRODUCTS. ON PUNITIVE
DAMAGES, THE PARTIES STIPULATED NEW JERSEY LAW WOULD APPLY AND NEW JERSEY LAW AND
PUNITIVE DAMAGES IS WELL SETTLED. THE TWO PRIMARY FACTORS ARE THE DEFENDANT'S
STATE OF MIND AND THE DEFENDANT'S CONDUCT. YOU REAFFIRMED THAT RECENTLY IN RIF
VAR RA VERSUS VALLEY HOSPITAL. AND HERE ALL OF THAT 510(K) EVIDENCE THAT I REFERRED
TO BEFORE IS CLEARLY RELEVANT ON THE DEFENDANT'S STATE OF MIND AND THE
DEFENDANT'S CONDUCT. LET ME SWITCH GEARS TO THE SECTION 5 ISSUE.
AND THE LEGAL ISSUE TO THE COURT ON SECTION 5 IS WHEN THE LEGISLATURE USED
THE WORDS APPROVED, LICENSED AND GENERALLY RECOGNIZED AS SAFE, DID THEY INTEND
THOSE WORDS TO HAVE THE WORDS OF ART OF THE FEDERAL STATUTE OR DID THEY
INTEND THAT THEY WOULD HAVE ORDINARY MEANING AND THE ANSWER TO THAT QUESTION IS
WITHIN THE WORDING OF SECTION 5. THE LAST SENTENCE OF SECTION
5 SAYS IT WITH THE WORDS DRUG, DEVICE, FOOD AND FOOD ADD DID IT DIFS SHALL
HAVE THE WORD OF ART MEANING OF FEDERAL STATUTES. IT DOES NOT SAY THAT AS TO APPROVED,
LIERNSED OR GENERALLY RECOGNIZED AS SAFE. FINALLY ON THE SECTION
5 ISSUE, THE COURT IN OUR VIEW NEEDS TO ALSO HEED SECTION 1 OF THE PRODUCT
LIABILITY ACT. SECTION 1 OF THE PRODUCT LIABILITY ACT DOES TWO
THINGS: FERS, IT SAYS THE COURT SHALL, AGAIN, THE VERB IS
SHALL, CONSIDER THE LEGISLATIVE HISTORY IN INTERPRETING THE ACT. HERE, BOTH THE
ASSEMBLY STATEMENT AND THE GOVERNOR'S PAST BLANK MEMORANDUM SPECIFICALLY SAY
THAT SECTION 5 APPLIES TO PRODUCTS THAT ARE REGULATED BY THE FDA AND EVERYONE IN
THIS CASE STIPULATES THESE PRODUCTS ARE REGULATED BY THE FDA.
THE OTHER THING THAT SECTION 1 DOES AND I HAVE NOT SEEN THIS IN THE STATUTE, THE
VERY FIRST SENTENCE OF THE PRODUCT LIABILITY ACT SAYS THAT THE
LEGISLATURE FINDS THAT THERE IS AN URGENT NEED FOR REMEDIAL LEGISLATION, ESPECIALLY
AS IT RELATES TO PUNITIVE DAMAGES SO IF YOU APPLY THE WORDS OF SECTION 5
AND/OR YOU DO WHAT THE LEGISLATURE INSTRUCTED YOU TO DO, WHICH IS TO CONSIDER THE
LEGISLATIVE HISTORY, TO US, IT IS AN INCHES SKAP ABDOMINAL CONCLUSION THAT SECTION
5 APPLIES TO PRODUCTS THAT ARE CLEARED UN THE 510(K) PROCESS BY THE FDA.
THE COURT: ARE YOU DONE WITH YOUR OPENING STATEMENT?
DAVID R. KOTT: YES, SIR. THE COURT: ON THE FIRST QUESTION,
LET'S START ON THE ISSUE OF THE STANDARD OF REVIEW HERE WE HAVE A THOUFL
ANALYSIS AN OPINION AT THE TRIAL COURT LEVEL, A THOUGHTFUL ONE AT THE APPELLATE
DIVISION LEVEL, DID THE APPELLATE TWIGS SUBSTITUTE IT'S JUDGMENT OR ABIDE
BY THE ABUSE OF DISCRETION STANDARD. DAVID R. KOTT: IT'S AN ACADEMIC
QUESTION HERE, CHIEF JUSTICE. WE CONTEND THAT IT'S A DE NOVO REVIEW BECAUSE
THE TRIAL JUDGE REFUSED TO INSTRUCT THE JURY ON THE NORTH CAROLINA PRODUCT LIABILITY
STATUTE. WE ASKED FOR A JURY INSTRUCTION CONSISTENT WITH THE
RISK UTILITY FACTORS AND CONSISTENT WITH REASONABLE -- DID THE MANUFACTURER ACT
REASONABLY, RIGHT OUT OF THE STATUTE. THE TRIAL COURT DECLINED
TO DO THAT AND IN DOING SO HE RELIED IN PART 'ON HIS INTERPRETATIONS OF THE
FEDERAL STATUTES AN REGULATIONS SO WE CONTEND IT'S DE NOVO. THE
REASON I SAY IT IS A NICE ACADEMIC QUESTION BECAUSE ASSUMING THAT IT'S AN ABUSE
OF DISCRETION STANDARD THERE WAS AN ABUSE OF DISCRETION STANDARD HERE BECAUSE
THERE WAS A MANIFEST DENIAL OF JUSTICE BECAUSE OF THE MANTRA BY THE PLAINTIFF'S
LAWYER ON THE LACK OF CLINICAL TESTING WHICH WE COULD NOT REBUT; AND, ALSO,
BECAUSE THE TRIAL JUDGE'S DISCRETIONARY RULING WAS BASED ON AN IMPERMISSIBLE
READING OF THE LAW AND THIS COURT HAS SAID TO A FEW DECISIONS THAT EVEN IF IT IS
AN ABUSE OF DISCRETION, WHEN IT'S BASED ON AN IMPERFECT MISSILE READING OF THE
LAW ITS EEGS NOT ENTITLED TO ANY DISCRETION. WAEN WAYNE SO IF YOU'RE
ARGUING THAT THE TRIAL COURT'S DECISION WAS BASED ON AN IMPERMISSIBLE READING OF THE
LAW DOES THAT MEAN YOU'RE ASKING US TO HOLD THAT 510(K) EVIDENCE MUST BE
ADMITTED IN EVERY CASE SO AS NOT TO DEPRIVE DEFENDANTS THE RIGHT TO A FAIR TRIAL.
DAVID R. KOTT: YES, NOT TO DEPRIVE THE DEFENDANT OF A FAIR TRIAL,
BUT BEYOND THAT BECAUSE IT IS RELEVANT TO THE STANDARD BE IT NORTH CAROLINA OR
NEW JERSEY, DID THE MANUFACTURER ACT REASONABLY IN DESIGNING THE PRODUCT
AND IN FORMULATING THE WARNINGS. JUSTICE WAINER APTER: I HEARD YOU
SAY IN YOUR OPENING THAT YOU HAD TO GO THROUGH THE 510(K) PROCESS AND THAT
BARD COULD NOT GO THROUGH THE PREAPPROVAL PROCESS, WHY IS THAT?
DAVID R. KOTT: THE REASON IS BECAUSE AND IN SOME OF THE COLLOQUY WITH MR. SLATER,
IN THE MID 1980S, THE FDA CONVENED THREE SCIENTIFIC PANELS FOR PHYSICIANS,
SCIENTISTS AN OTHERS AN THEY RECOMMENDED THAT SURGICAL MESH BE PLACED IN CLASS II
AND IN 1988 THE FDA PLACED SURGICAL MESH IN CLASS II, WHICH UNDER THE FEDERAL
STATUTES THEY COULD ONLY DO IF THAT ENSURED A REASONABLE ASSURANCE OF SAFETY
AN EFFICACY E. TO ANSWER NOW THE QUESTION, UNDER THE FEDERAL
STATUTES, ONCE SURGICAL MESH IS PUT IN CLASS II, THE ONLY AVENUE AVAILABLE TO THE
MANUFACTURER IS 510(K). THE MANUFACTURER CANNOT USE THE PREMARKET APPROVAL
PROCESS. JUDGE ACCURSO: MR. SLATER IS ARGUING THAT IT IS
NOT JUST THE MESH, IT'S THE TOOLS, THE PROCESS WHERE THESE ARMS ARE ANCHORED, THAT
THAT MAKES THIS A NEW PRODUCT. WHY COULDN'T YOU HAVE GONE UNDER
A NEW PRODUCT AND NOT GONE UNDER SECTION 2 APPROVAL? DAVID R.
KOTT: WELL, IT IS THE FIRST TIME I THINK I AM HEARING THAT ARGUMENT BY MR. SLATER,
ALL THROUGH THIS CASE, MEANING, THE APPELLATE TWIGS AN THE TRIAL COURT IS
TODAY. TO ANSWER YOUR QUESTION, YOUR HONOR, THE DEVICES, THE
TOOLS, ALSO, ARE SUBJECT TO GOVERNMENT REGULATION. JUDGE
ACCURSO: RIGHT, AS A CLASS I. DAVID R. KOTT: AS A CLASS I. AND
WE HAD APPROVAL TO SELL THEM. IF HIS ARGUMENT NOW -- I AM GOING
TO LAPSE OVER TO THE OTHER. IF HIS ARGUMENT IS WELL, IT'S CLASS I, THAT
'S THE LEAST REGULATED OF THE -- I AM NOT SURE I'M ANSWERING YOUR QUESTION, YOUR HONOR.
JUDGE ACCURSO: YOU COULDN'T DECIDE THAT THIS IS A NEW PRODUCT?
I LOOKED AT THE GUIDANCE, I THOUGHT ONE COULD SAY WE'RE USING
MESH, BUT THIS IS ACTUALLY A COMPLETELY NEW THING AND COME IN AS A NEW PRODUCT?
DAVID R. KOTT: I AM NOT SURE I KNOW THE REGULATORY ANSWER
TO THAT. HOWEVER, WHEN WE LOOK AT THE ENTIRE TRIAL RECORD HERE,
THERE IS NO COMPLAINTS OVER HERE ABOUT THE TOOLS. THE ENTIRE COMPLAINT WAS THE
MESH, POER SIZE, OTHER ASPECTS OF THE MESH; THAT'S WHAT THE ENTIRE TRIAL WAS
ABOUT, NOT ABOUT THE TOOLS THAT WAS USED. JUSTICE WAINER APTER:
WHAT ARE WE TO MAKE OF 21 C.F.R. 87 DOT 97 WHICH SAYS A FINDING THAT A DEVICE
IS SUBSTANTIALLY EQUIVALENT TO A DEVICE ALREADY IN DISTRIBUTION DOES NOT IN ANY
WAY DENOTE OH IF I RECALL APPROVAL OF THE DEVICE? DAVID R. KOTT:
THAT IS A REGULATORY REQUIREMENT OF THE FDA DEALING IN MARKETING. YOUR HONOR,
I DON'T THINK THAT HAS ANYTHING TO DO WITH THE EVIDENTIAL QUESTIONS HERE.
I WILL CONCEDE, WE WILL NOT ARGUE AT TRIAL, IF WE GET A NEW TRIAL, WE'RE NOT
GOING TO SAY THAT IT HAD APPROVAL, BUT THAT DOESN'T REALLY ANSWER THE
QUESTION OF WHETHER THE TRIAL COURT PROPERLY EXCLUDED THIS EVIDENCE. AND, I WOULD
ADD, IT DOES NOT ANSWER THE QUESTION UNDER SECTION 5 WHERE THE WORD APPROVED IS
USED BECAUSE IN SECTION 5, WE'RE LOOKING AT THE LEGISLATIVE INTENT NOT WHAT
THE FDA IN WASHINGTON, D.C. DID WAN WAYNE SO YOU WOULD ARGUE THAT YOUR PRODUCT
WAS APPROVED PURSUANT TO SECTION 5, BUT WAS NOT APPROVED PURSUANT TO THE
FDA REGULARS? DAVID R. KOTT: OUR ARGUMENT SPECIFICALLY IS
THAT THE WORD APPROVED IN SECTION 5 SHOULD HAVE ITS ORDINARY MEANING, NOT IT'S WORD
OF ART MEANING IN THE FEDERAL STATUTES. AND WHEN WE LOOK AT THE DICTIONARY,
APPROVED IS A SANCTION TO DO SOMETHING. NO ONE QUESTIONS HERE THAT THE FDA GAVE
US PERMISSION AND ALLOWED US TO SELL THESE PRODUCTS. JUDGE
ACCURSO: SO YOU WOULD HAVE TO AGREE WITH MR. SLATER THAT THE APPELLATE DIVISION
OPINION IS INCONSISTENT? DAVID R. KOTT: PARTICULARLY IN
ONE PART. I AGREE WITH WITH MR. SLATER ON THIS, HE SAID ON
HIS REPLY BRIEF ON THE CERTIFICATION THERE IS NO NEED FOR A 104 HEARING BECAUSE
THERE WAS A MASSIVE OFFER OF PROOF BY BARD, WHICH THERE WAS. SO
WHAT ARE WE GOING TO DO ESSENTIALLY IN PUTTING IT IN LAY TERMS IN A 104.
SO I AGREE WITH MR. SLATER THAT WE DON'T NEED A 104 HEARING.
WHAT I DON'T THINK THE APPELLATE DIVISION IS SAYING IS THAT ULTIMATELY THE TRIAL COURT
COULD EXCLUDE THE EVIDENCE FOR THE REASONS I'VE SAID BEFORE. 510(K)
EVIDENCE IS ALWAYS RELEVANT EVEN IF WE TRY THE CASE UN NEW JERSEY LAW, IS ALWAYS
RELEVANT ON THE REASONABLENESS OF THE MANUFACTURER'S DESIGN DECISIONS AND
WARNING STIGSZ DECISIONS. IF WE HAVE A 104 HERG HEARING, MAYBE THE
ISSUES ARE TIME LIMITS. MAYBE THE ISSUES ARE WHAT CAN WE SAY, MEANING,
CAN WE SAY APPROVED? NO. MAYBE THE ISSUE IS,
HEY, COUNSEL, HOW DO I DEAL WITH THIS LIMITING SECTION. WHAT
DOES THAT DO? IN THIS CASE WE DON'T THINK A 104 HEARING IS NEED,
SO IF YOU ARE ASKING ME NOW TO BE A FRIEND OF THE COURT, BROADER IN THESE CASES,
I DON'T KNOW THAT IT'S NEEDED, I THINK I WOULD LEAVE THAT TO THE DISCRETION OF
THE TRIAL JUDGE THE WAY 104 HEARINGS ARE NORMALLY LEFT TO THE DISCRETION
OF THE TRIAL JUDGE. THE COURT: YOU AGREE THAT THE PRODUCT COULD
NOT BE SOLD IF THE PRODUCT WAS IMPROVED. DAVID R. KOTT: YES,
I ABSOLUTELY AGREE WITH THAT. THE COURT: YES, YET THAT RAISES
A QUESTION AS TO WHETHER THERE IS A TENSION WITH THE SECTION 5 THAT YOU'RE
USING. DAVID R. KOTT: BECAUSE WE'RE DOING DIFFERENT THINGS.
IN SECTION 5, WE'RE LOOKING AT LEGISLATIVE INTENT, ON THE FIRST PART, WHAT THE
JURY COULD BE TOLD, WE ARE LOOKING AT THE RULES OF EVIDENCE AND WHAT I AM
SAYING IS THE V YES, WE CAN CANNOT TELL THE JURY UNDER THE RULES OF EVIDENCE THAT
IT WAS APPROVED, BUT WHEN WE MOVE OVER TO SECTION 5, APPROVED IS NOT A WORD
OF ART UNDER THE FEDERAL STATUTES, IT'S ITS ORDINARY MEANING.
CHIEF JUSTICE RABNER: AND ISN'T THE ORDINARY MEANING OF THE TERM APPROVED THAT
YOU CONCEDED THERE WOULD BE A CONCERN IN PRESENTING THAT LANGUAGE TO THE
JURY? DAVID R. KOTT: THE REASON I CONCEDED THAT IS BECAUSE
UNDER FEDERAL LAW WE CANNOT SAY THAT. I WOULD BE -- IF I WERE TRIAL COUNSEL AND
I TURNED TO THE JURY AND I SAID APPROVED, I WOULD BE VIOLATING THE FEDERAL LAW.
JUSTICE WAINER APTER: THE COURT IN WOOIN BERG GER ALLOWED
THE 510(K) EVIDENCE TO COME IN WITH A LIMITING INSTRUCTION THAT SAID THAT THE
510(K) CLEARING PROCESS IS NOT TO BE CONSIDERED AS EVIDENCE THAT THE FDA
AUTHORIZED THE PRODUCT AS SAFE AND I APPROVED IETSD EASE INTENDED USE AS SUCH THAT
THE 510(K) IS NOT EVIDENCE THAT THE DEFENDANT: IF A SIMILAR
LIMITING INSTRUCTION WERE TO BE USED IN THIS CASE WHAT WOULD YOU WANT THE EVIDENCE
IN FOR? ' DAVID R. KOTT: ON ON THE REASONABLENESS OF OUR
CONDUCT, BOTH IN TERMS OF THE PRODUCT LIABILITY CLAIM AN PUNITIVE DAMAGES. AND, YOUR HONOR, I WOULD JUST SAY THIS, AS MR. PLACITELLA HAD NOTED, THIS CASE WILL
LAW. I CALL THIS COURT'S ATTENTION TO MODEL JURY CHARGE 5.4
0 D 42, 5.40 D 42, WHICH IS A SPECIFIC JURY INSTRUCTION, A LIMITING INSTRUCTION
ON WHAT THE JURY DOES WITH FDA EVIDENCE. I AM GOING TO PARAPHRASE IT VERY
QUICKLY. BASICALLY, IT SAYS, YOU HEARD FDA EVIDENCE, THAT IS ONE FACTOR HERE FOR
YOU TO CONSIDER. IT'S NOT DETERMINATIVE. YOU STILL CAN FIND THE PRODUCT
DEFECTIVE EVEN THOUGH THE FDA CLEARED IT SO I WOULD CALL THE COURT'S ATTENTION.
AGAIN, I PARAPHRASED IT, IT MIGHT NEED TO BE MODIFIED SOMEWHAT,
BUT IT GETS THE TRIAL JUDGE TO THE 20 YARD LINE ON WHAT THE LIMITING INSTRUCTION
SHOULD BE. UNIDENTIFIED JUDGE: FEDERAL REG THAT PROHIBITS
YOU FROM SAYING THAT THE 510(K) IS AN APPROVAL, THAT I THINK WAS ADOPTED IN 19
77. OUR PUNITIVE DAMAGES ACT WAS ADOPTED TEN YEARS LATER. WHY
WOULDN'T WE THINK THAT THEY KNEW THAT AND THEY USED IT THAT WAY?
DAVID R. KOTT: BECAUSE I DON'T THINK IN DETERMINING THE LEGISLATIVE INTENT, WE
LOOK AT WHAT THE FDA DID AND WE KNOW WHAT THE LEGISLATIVE INTENT IS HERE FROM
THE HISTORY, THE LEGISLATIVE HISTORY. I INCORPORATE BY REFERENCE WHAT I SAID BEFORE,
SECTION 1, THE ASSEMBLY STATEMENT AN THE GOVERNOR'S PAST BILL MEMORANDUM
SAY ALL THOSE TERMS, WHAT WE'RE TALKING ABOUT IS REGULATED.
JUSTICE WAINER APTER: IF THE COURT WERE TO AGREE WITH YOU THAT 510(K) EVIDENCE
IS ADMISSIBLE, THEN PLAINTIFFS WOULD BE PERMITTED TO INTRODUCE EVIDENCE THAT
THE FDA EVENTUALLY RECLASSIFIED PELVIS MESH AS A CLASS III DEVICE REQUIRING PREMARKET
APPROVAL, RIGHT? DAVID R. KOTT: NO, I DON'T THINK SO. EARLY IN
THE APPELLATE DIVISION IN THIS CASE, JUDGE SABATINO AN HE'S GOT A COUPLE OF
SENTENCES ON THAT WHERE HE REFERS TO EVIDENCE RULE 407, BUT MORE IMPORTANTLY THAN
EVIDENCE RULE 407, THE REASON THAT WOULD NOT BE ALLOWED IS UNDER THE NORTH
CAROLINA STATUTE AND IT'S THE SAME THING IN NEW JERSEY, WHETHER OR NOT A PRODUCT
IS DEFECTIVE IS DETERMINED AT THE TIME IT LEFT THE CONTROL OF THE DEFENDANT.
SO, PUTTING ASIDE RULE 407, JUST RELEVANCE, IT WOULD NOT BE
RELEVANT THAT A NUMBER OF YEARS LATER THE FDA RECLASSIFIED ONE OF THE TWO PRODUCTS.
THE COURT: CAN YOU PARSE FOR US THE LANGUAGE IN SECTION 5
AND TELL US WHICH OF THE THREE AREAS YOU ARE RELYING ON? DAVID
R. KOTT: APPROVED, USING THE DEFINITION OF APPROVED THAT I SAID BEFORE. WE BELIEVE
L THIS PRODUCT WAS APPROVED AS SANCTIONED. LICENSE, WHICH THIS
COURT HAS RECOGNIZED IN OTHER STATUTES THE ADMINISTRATIVE PROCEDURE ACT, THE
LEGITIMATE YOUR DEFINED LICENSED AS PERMISSION TO DO SOMETHING OTHERWISE ILLEGAL.
AND, GENERALLY RECOGNIZED AS SAFE. I NEED TO EXPLAIN HOW I
GET THERE. THE COURT: I JUST HAVE A QUESTION ABOUT THE FIRST
PRONG BEFORE YOU GET TO THE THIRD. DAVID R. KOTT: SURE, SURE.
THE COURT: WAS THIS APPROVED UNDER THE FOOD & DRUG ADMINISTRATION
UNDER THE FEDERAL FOOD DRUG AN COSMETIC ACT? DAVID R. KOTT:
THE ANSWER IS YES AND IT WAS THE STATUTE IN SECTION 5 WHAT YOUR HONOR IS REFERRING
TO UNDER THE FEDERAL FOOD DRUG AND COSMETIC ACT, IT SAYS ETCETERA WHICH
DRAGS IN THE ENTIRE ACT WHICH WOULD DRAG IN CLEAR DEVICES. AND
IF WE'RE CORRECT, YOUR HONOR, THAT APPROVED HAS AN ORDINARY MEANING, THEN THE
PRODUCTS WERE CLEARLY APPROVED. JUSTICE WAINER APTER: BUT
WERE THEY' PROVED UNDER THE FD C A? DAVID R. KOTT: YES BECAUSE
THE FD C A AGAIN, SAYS, ETCETERA WHICH DRAGS IN THE ENTIRE ACT AND I WOULD
ALSO COME BACK TO THE -- THE COURT: AND THEREFORE -- FINISH THAT
THOUGHT IF YOU WOULD. DAVID R. KOTT: AN THEREFORE INCLUDES
AGAIN IN OUR VIEW ANYTHING THAT IS APPROVED AS SANCTIONED TO SELL.
JUSTICE PIERRE-LOUIS: BUT, AGAIN, GOING BACK TO THE REGULATIONS,
SO YOU'RE ARGUING THAT UNDER THE FOOD, DRUG AN COSMETIC ACT, THIS DEVICE WAS
APPROVED, BUT WHEN WE GET TO THE REGULATION THE DEFINITION OF APPROVED IN THAT
REGULATION, IT SAYS THIS CANNOT BE MARKETED AS HAVING BEEN APROOIFD IS A DIFFERENT
DEFINITION. DAVID R. KOTT: I AM. AND PART OF THE SUPPORT
FOR THAT IS THE LAST SENTENCE. NOW I AM GOING TO COME BACK, THE DEFINITION OF
DRUG, DEVICE, FOOD AND FOOD ADDITIVE IS THE SAME DEFINITION AS IN THE FEDERAL
STATUTES. WELL, THE FEDERAL STATUTES CONTEMPLATE DEVICES
GO THROUGH THE 510(K) CLEARANCE PROCESS. JUSTICE WAINER APTER:
WHAT ABOUT THE FIRST SENTENCE OF THE ACT WHERE WIT SAYS PUNITIVE DAMAGES BEFORE
BEFORE, IT SAID, PUNITIVE DAMAGES SHALL NOT BE AWARDED IN A DEVICE WHICH CAUSED
THE CLAIM IN TERM WAS SUBJECT TO PREMARKET APPROVAL OR LICENSURE BY THE FDA UNDER
BLAH BLAH AND WAS APPROVED OR LICENSED SO DOESN'T THE WORD AND WAS APPROVED MEAN
UNDER PREMARKET APPROVAL BECAUSE A FEW WORDS BEFORE THE STATUTE SAID WAS SUBJECT
TO PREMARKET APPROVAL? DAVID R. KOTT: I THINK, BUT I AM
NOT SURE, YOUR HONOR, AND THE QUESTION MAY BE ASSUMING THAT WE'RE NOT USING
THE ORDINARY LANGUAGE OF SECTION 5, BUT KAIN. JUSTICE WAINER APTER:
I AM JUST REFERRING TO THE WORDS WHERE IT SAYS: WAS SUBJECT TO PREMARKET
APPROVAL AND THEN IT SAYS UNDER THE VARIOUS LAWS AND THEN IT SAYS AND WAS APPROVED.
SO I UNDERSTOOD YOUR ARGUMENT WHEN YOU WERE SAYING THE WORD
APPROVED HAD IT NOT PREVIOUSLY A FEW WORDS BEFORE SAID WAS NOT SUBJECT TO PREMARKET
APPROVAL, I WOULD UNDERSTAND THAT THE WORD APPROVED DOESN'T MEAN UNDER THE
FDA DEAF INITIATING, IT MEANS UNDER THE GENERAL MEANING OF THE WORD, BUT BECAUSE
A FEW WORDS BEFORE IT SAYS WAS SUBJECT TO PREMARKET APPROVAL, I AM JUST
NOT SURE, ARE THOSE WORDS JUST STRUCK FROM THE STATUTE? DO
THEY NOT HAVE ANY RELEVANCE? DAVID R. KOTT: NO, I THINK BECAUSE
THEY NEED -- THEY INCORPORATE THE FEDERAL STATUTE IN THAT AREA BECAUSE THEY
NEED TO PUT A BOUN DREE ON WHAT THEY'RE TALKING ABOUT. BUT,
I YOU -- AGAIN, THE QUESTION, I THINK THE LEGAL ISSUE IS, DID THEY INTEND TO HAVE
THOSE WORDS HAVE THE WORD OF ART OF OF THE FEDERAL STATUTES. THE
COURT: ASSUME THAT THEY JUST GET COMMON ORDINARY MEANING. DAVID
R. KOTT: RIGHT. THE COURT: ISN'T THERE A DEFENSE BETWEEN
PREMARKET APPROVAL AND A CLEARANCE PROCESS. DAVID R. KOTT: THERE IS.
CHIEF JUSTICE RABNER: AND YET THIS LANGUAGE, THE ORDINARY
TERM USED IS PREMARKET APPROVAL AND APPROVAL? HAD. DAVID R.
KOTT: RIGHT. AND I DON'T KNOW THAT THAT ANSWERS THE QUESTION BECAUSE, AGAIN, WAS
THE LEGISLATURE USING THOSE TERMS ORDINARY TERMS, WHICH FROM THE LEGISLATIVE
HISTORY, IT LOOKS LIKE THEY WERE; OR, WAS THE LEGISLATURE USING THEM AS TERMS OF
ART. WHEN WE LOOK AT THE LAST SECTION OF SECTION 5, THE LAST
SENTENCE, IT IS CLEAR THEY DID NOT INTEND THOSE TERMS TO HAVE THE WORD OF ART AN
CHIEF JUSTICE IF I COULD COME BACK TO GENERALLY RECOGNIZED AS SAFE.
THE COURT: I AM GOING TO ENCOURAGE YOU TO. DAVID R. KOTT: THANK YOU.
AS THE COLLOQUY WITH MR. SLATER, IN 1988 WHEN THE FDA PUT MESH
IN CLASS THE 2, UNDER THE STATUTES THEY COULD ONLY DO THAT UPON A REASONABLE
ASSURANCE OF SAFETY AN EFFICACY. AND THE OTHER THING I WOULD
ENCOURAGE THE COURT TO LOOK AT IS THE RECORD IN THIS CASE. WE OBTAINED
FROM THE FDA THEIR FILES FOR THE FREED THROUGH THE FREEDOM OF INFORMATION ACT REQUEST
AND A LINE APPEARS IN THE APPELLATE APRIL PEND DICK AT 2426 AN MANY PAGES
THEREAFTER OF AVENUE VAULT TA 2595 AND IN THE FDA'S OWN DOCUMENTS IT'S LOADED WITH
SAFETY INFORMATION, BUT ALSO, CHIEF JUSTICE RAB IN HER, THERE ARE A NUMBER
OF PLACES IN THERE AN ON PAGE 18 OF OUR PREEF IN OPPOSITION TO MR. SLATER'S CERTAIN
PETITION WE HAVE PINPOINT CITES. A NUMBER OF PLACES IN THE
FDA'S OWN FILE WHERE THEY SAY AS TO THESE PRODUCTS, THEY ARE SAFE AND EFFECTIVE
SO ASSUMING FOR A MOMENT THAT THE COURT DISAGREES WITH ME ON APPROVAL, DIS DPRAES
WITH ME ON CLOP C E R T CLOP. DIS GREASE WITH ME ON LICENSE, WHEN WE LOOK
AT WHAT THE FDA DID IN 1988 CLASSIFYING THE PRODUCTS IN CLASS II AND WHEN WE LOOK
AT THE RECORD IN THIS CASE, WHAT THE FDA SAID ABOUT THE TWO PRODUCTS, IT, ALSO,
MEETS GENERALLY RECOGNIZED AS SAFE. JUSTICE SOLOMON: HAVEN'T A
NUMBER OF FEDERAL CASES SAID 510(K) DOES NOT ESTABLISH APPROVAL OR LICENSURE?
THE. DAVID R. KOTT: YES. ACTUALLY, JUSTICE SOL, I THINK
IF YOU LOOK AT ALL THE FEDERAL CASES, MOST OF THEM EXCLUDE 510(K). MOST OF THEM
START BY SAYING IT'S PROBATIVE, BUT THEN THEY EXCLUDE IT UNDER 403.
AND RULE 403 IS VERY RECORD SPECIFIC. AND WHEN I LOOK AT THOSE CASES THAT EXCLUDED
IT, WE DON'T HAVE A NO CLINICAL TESTING ARGUMENT MADE BY THE PLAINTIFF HERE.
WHAT IS MOST IMPORTANT ON THAT QUESTION -- JUSTICE
SOLOMON: I AM JUST STICKING TO THE NARROW ISSUE YOU RAISED THAT IT IS SOMEHOW --
IT IS APPROVED OR LICENSED UNDER SECTION 5 OF THE PLA AND I AM SAYING, YES,
BUT HAVEN'T A NUMBER OF FEDERAL CASES SAID NO, IT IS NOT? DAVID R.
KOTT: AND WHAT I WAS GOING TO ADD, YOUR HONOR, IS A LOT OF THOSE CASES, THE ARGUMENTS
WE MAKE HERE WERE NOT MADE TO THOSE COURTS. IN FACT, THE 11
CIRCUIT DECISION IN EVENING L HIEM, FOOTNOTE 3 SPECIFICALLY SAYS, THE DEFENDANT
DID NOT ARGUE AN THEN IT'S EVERYTHING WE ARGUE HERE, SO WE'RE NOT GOING
TO CONSIDER IT. IN THE LAST THREE OR FOUR YEARS, A NUMBER OF
MANUFACTURERS HAVE MADE THE ARGUMENTS WE MAKE HERE AND THE CLEAR TREND AROUND THE
COUNTRY AMONG FEDERAL JUDGES DESPITE THREE CIRCUIT COURTS, THE CLEAR TREND IS TO
ADMIT THE EVIDENCE. MENT. IN A LOT OF THOSE CASES SAY IT IS
PROBATIVE. JUSTICE SOLOMON: DOES IT SAY THEY ARE APPROVED
OR LICENSED? DAVID R. KOTT: NO IT DOES NOT SAY APPROVED OR
LICENSED. JUSTICE SOLOMON: I UNDERSTAND YOUR ARGUMENT THAT
IT'S GENERALLY SAFE AND EFFECTIVE, I GET THAT. DAVID R. KOTT: YES.
JUSTICE SOLOMON: BUT I DON'T GET THE ARGUMENT THAT IT IS
LICENSED OR APPROVED BECAUSE A NUMBER OF FEDERAL CASES UNDER THE FDA HAVE SAID
510(K) DOESN'T SAY THAT. DAVID R. KOTT: AMERICAN AGAIN, IN
MANY OF THOSE 510(K) CASES, THE VERY ARGUMENTS WE MADE HERE WERE NOT MADE
IN THOSE CASES. THE COURT: DOES THE OO 510(K) PROCESS AS YOU
UNDERSTAND IT DIRECTLY ADDRESS SAFETY AND -- DAVID R. KOTT: IT DOES,
CHIEF JUSTICE. THERE IS A LOT OF BRIEFING ON THIS, BUT WHEN YOU LOOK AT THE
FEDERAL STATUTES AN THE FEDERAL REGULATIONS, IT IS CLEAR THAT THE CLEARANCE PROCESS
INVOLVES SAFETY. AND, BEYOND THAT, CHEECH JUSTICE, THE FDA HAS
SAID AN THEY SAID IT CLEAR AS A BELL FOUR OR FIVE TIMES THAT IN EVERY, IN EVERY
510(K) REVIEW, THEY CONSIDER SAFETY AN EFFICACY. AND SO HAS
THE U.S. SUPREME COURT. CHIEF JUSTICE RABNER: THE FD IN ITS
GUIDELINES ON THE 510(K) PROGRAM SPEAKS OF THE PROCESS AS A COMPARE RAT TI ONE,
NOT ONE THAT TREKTLY TRAES ES SAFETY AN EFFECTIVENESS. HAVE
I MISUNDERSTOOD THAT? DAVID R. KOTT: I READ SOME OF THE FDA GUIDE
I GUIDELINES DIFFERENTLY. I DON'T THINK THEY ARE SAYING IT'S JUST COMPAR
ATIVE. I THINK WHAT THEY ARE SAYING IS WE DO LOOK AN THE WORDS EVERY, THE WORD
EVERY IS THERE AND IN EVERY 510(K) PROCESS, WE LOOK AT SAFETY AN
EFFECTIVENESS. THE COURT: SO MY QUESTION IS DOES IT DO SO DIRECTLY,
IF STATE'S OF COURSE AN WE UNDERSTAND THAT SAFETY AN EFFECTIVENESS UNDERLIE THE
PROCESS, BUT DOES IT MAKE A DIRECT DERMTHS OF SAFETY AN EFFECTIVENESS?
DAVID R. KOTT: LOOKING AT THE RECORD IN THIS CASE, IT SURLLY DID;
THAT'S WHY I GAVE THE CITES TO WHERE THE FDA RECORDS WERE BECAUSE THEY WERE LOOKING
AT BIOCOMPATIBILITY, THEY WERE LOOKING AT A HUGE NUMBER OF CASE KA, TESTS
UNRELATED OR COMPARATIVE. EVEN IF WE ASSUME COMPARATIVE I HAVE, WE'RE
COMPARING THEM TO PRODUCTS THAT HAVE PREVIOUSLY COMPARED TO FDA AND
PRODUCTS THAT ARE OUT IN THE MARKET. JUSTICE PIERRE-LOUIS: BUT THERE IS
NO INDEPENDENT DETERMINATION NAGS WITH REGARD TO THE NEW DEVICE WHETHER IT IS
SAFE AN EFFECTIVE. TO FOLLOW UP ON THE CHIEF JUSTICE ES QUESTION,
THE PRODUCT. RATHER THAN AN INDIANA DEMONSTRATION OF THE NEW
DEVICES SAFETY AN EFFECTIVE. DAVID R. KOTT: HE WAS MAKING A CLEAR
DISTINCTION BETWEEN P.M. A APPROVAL THAT IS FOCUSED ON SAFETY AND EFFECTIVENESS
AND THE 510(K) PROCESS WHICH IS NOT AND WE DISCUSSED THIS ALREADY, THERE MIGHT BE
SAFETY UNDERLYING, BUT THAT'S NOT THE FOCUS OF THE 510(K) DETERMINATION,
THE FOCUS IS, IS THIS THE SAME AS THIS OTHER DEVICE ON THE MARKET.
DAVID R. KOTT: AN JUSTICE POOER LOU, THE COMPARATIVE PROCESS IS SAFETY AN
EFFECTIVENESS FOR THE REASONS I SAID A MINUTE AGO, WHICH IS THEY ARE COMPARING
IT TO PRODUCTS THAT ARE OUT ON THE MARKET WHERE THEY ARE AWARE OF WHAT IS
GOING ON WITH THOSE PRODUCTS. I MEAN, PRODUCTS OUT ON THE MARKET ARE
BETTER THAN CLINICAL TRIALS. THEY ARE IN CLINICAL USE BY PHYSICIANS AND
HOSPITALS. JUSTICE WAINER APTER: IS THAT TRUE EVEN FOR PRODUCTS
THAT WERE ON THE MARKET BEFORE 1976. DAVID R. KOTT: NO. I DO NOT
KNOW THE ANSWER, BUT I DON'T THINK SO, YOUR HONOR. JUSTICE
PIERRE-LOUIS: BUT, AGAIN, IT'S A COMPARISON AND WITH EACH DIFFERENT DEVICE
THERE IS DIFFERENT MATERIALS THAT COULD BE USED, CORRECT? DAVID R.
KOTT: CORRECT. JUSTICE PIERRE-LOUIS: HERE, BARD WAS USING A
MATERIAL THAT IT WAS AWARE SHOULD NOT HAVE BEEN USED FOR IMPLANTATION IN THE HUMAN
BODY, CORRECT? DAVID R. KOTT: THAT'S THE CLAIM OF THE
PLAINTIFF. JUSTICE PIERRE-LOUIS: BUT THERE WAS SOME
TESTIMONY WITH REGARD TO WHAT BARD HAD BEEN TOLD BY THE MANUFACTURER OF THE PRODUCT.
DAVID R. KOTT: RIGHT. JUSTICE PIERRE-LOUIS:
HOW THAT PRODUCT SHOULD AND SHOULD NOT HAVE BEEN USED. DAVID R.
KOTT: RIGHT. JUSTICE PIERRE-LOUIS: AND THE FACT THAT BARD
NEVERTHELESS USED THAT MATERIAL. DAVID R. KOTT: THERE WAS SOME SOME
EVIDENCE TO THAT EFFECT. JUSTICE PIERRE-LOUIS: IN THE TECHNO
LOGICAL CHARACTER I SEE. IKS PORG OF THE 510(K) DETERMINATION,
THAT COMPARISON IS DRINL, DRIVEN BY WHAT THE MANUFACTURER TELLS THE FDA
WITH REGARD TO THE TECHNICAL ASPECTS OF THE PRODUCT TO DETERMINE WHETHER IT'S SIMILAR
TO THIS OTHER DEVICE THAT'S ON THE MARKET AND WHETHER IT'S GENERALLY SAFE
AND EFFECTIVE. DAVID R. KOTT: RIGHT. JUSTICE
PIERRE-LOUIS: BUT IF INFORMATION DOES NOT PRESENTED IN THE SAME MANNER THAT IT
WAS PRESENTED FROM THE MANUFACTURER HERE CLOP IS NOT CLOP THERE IS NO WAY
DURING THE 510(K) PROCESS FOR THE FDA -- THERE IS NO CHECK WITH REGARD TO WHETHER
THE SPECIFIC DEVICE AND ALL THE MATERIALS THAT ARE BEING USED IS SAFE AND
WON'T KAUSZ ANY HARM. DAVID R. KOTT: IT'S NOT ONLY WHAT BARD TOLD
THE FDA. BARD GAVE THE FDA BIOCOMPATIBILITY TESTING AND A WHOLE
VARIETY OF OTHER TESTING ON THE MESH MATERIAL. SO THE FDA HAD TESTING ON THAT AS
WELL. JUDGE ACCURSO: WHAT ARE WE TO MAKE OF THE FDA'S AM
ICUS FILINGS IN THE CIRCUIT COURT WHERE IT HAS THE CIRCUITS THAT RELIED ON AMICUS
FILINGS WHERE THE FDA SAYS WE'RE NOT DOING A SAFETY REVIEW IN A 510(K), NENS.
DAVID R. KOTT: AND THOSE AMICUS FILINGS ARE OUT THERE, BUT
THEY ARE ALSO INCONSISTENT WITH WHAT THE FDA HAS SAID IN THEIR GUIDANCES AN THERE IS
SOMETHING INTERESTING ABOUT THE GUIDANCES IN THE SAFETY MEDICAL DEVICE ACT
OF 1990, WHEN THE CONGRESS BEEFED UP THE CLEARANCE PROCESS, THE CONGRESS INSTRUCTED
THE FDA TO PUT OUT GUIDANCES AS A CONTROL. SO THE GUIDANCES HERE ARE PUT
OUT BY THE FDA BECAUSE THE CONGRESS TOLD THEM TO PUT OUT INFORMATION ON YOUR PROCESS
SO ACKNOWLEDGE THERE IS SOME INCONSISTENCY IN AMICUS FILINGS. I AM NOT SURE I
AM RIGHT ON THIS, YOUR HONOR, BUT I THINK THE ISSUE THERE WAS NOT ADMISSIBILITY
OF THE EVIDENCE AND DID THIS DEFENDANT GET A TRIAL. I THINK THAT WAS ON OTHER
ISSUES. THE COURT: OTHER QUESTIONS ANYONE?
ANYTHING YOU WOULD LIKE TO ADD MR. KOTT? DAVID R. KOTT: YES, BRIEFLY.
THIS COURT HAS SAID ON TWO OR THREE OCCASIONS THAT THE HALLMARK
OF OUR CIVIL JUSTICE SYSTEM IS FAIRNESS. AND THAT IS EE REFLECTED IN YOUR CASE
LAW. ONE EXAMPLE IS OPENING THE DOOR, WHICH CLEARLY APPLIES HERE, BUT IT IS
ALSO REFLECTED IN RULE 1:1-2 OF THE COURT RULES AND MOST IMPORTANTLY, IT IS REFLECTED
IN RULE 102, EVIDENCE RULE 102. AND ANY FAIR READING OF THIS RECORD WOULD
SHOW THAT BARD DID NOT GET A FAIR TRIAL AND, THEREFORE, WE ASK THIS COURT TO AFFIRM
THE JUDGMENT OF THE APPELLATE DIVISION VACATING THE JUDGMENTS RENDERED
AGAINST BARD BELOW. CHIEF JUSTICE RABNER: THANK YOU.
TO THE THREE AM MEEK KEY WE'RE ABOUT TO INVITE I WOULD ASK YOU TO PLAN FOR NO
MORE THAN 10 MINUTES FOR YOUR PRESENTATIONS. MR.
ROGERS. DANIEL B. ROGERS: MAY IT PLEASE THE COURT.
THANK YOU FOR ALLOWING US THE PRIVILEGE OF PARTICIPATING IN THE ORAL ARGUMENT TODAY
TO PRESENT SOME OF THE VIEWS ON BEHALF OF MY CLIENTS, THE AM MEEK KEY.
WE'RE HERE TO BETTER HELP THE COURT UNDERSTAND THE 510(K) PROCESS AND TO ALSO
UNDERSTAND WHY THE APPELLATE TWIGS GOT THIS ONE RIGHT AN CORRECTLY HELD THAT
THIS IS EVIDENCE THAT SHOULD BE ADMISSIBLE IN PRODUCTS LIABILITY CASES, PARTICULARLY
PRODUCTS LIABILITY CASES LIKE THIS THAT INVOLVE PUNITIVE DAMAGES.
NOW, THE 510(K) CLEARANCE PROCESS IS ESPECIALLY IMPORTANT PART OF THE
COMPREHENSIVE FEDERAL REGIME FOR REGULATION OF MEDICAL DEVICES THAT HAS TWO PRIM
ARY GOALS. THE FIRST PRIMARY GOAL, PROVIDING REASONABLE ASSURANCE
THAT MEDICAL DEVICES ARE SAFE AND EFFECTIVE. THE SECOND IS ENCOURAGING
IN VOE VACATION IN PATIENT ACCESS TO THOSE NEEDED 510(K) DEVICES. #
510(K) PATHWAY TO DH WE BRING TO MARKET THE VAST MAJORITY V DEVICES THAT ARE NEED
NEEDED FOR PATIENT HELD, HEALTH TO SAFE PEOPLE'S LIVES. THIS
PATHWAY REQUIRES THAT MANUFACTURERS USE THE JUDGMENT OF THE FEDERAL AGENCY THAT
THEY HAVE TO GO THROUGH THIS PARTICULAR FORM BECAUSE -- AN BECAUSE THAT
PARTICULAR FORM WILL PROVIDE A REASONABLE ASSURANCE OF SAFETY AN EFFECTIVENESS,
BUT THEY WOULD ALSO ENSURE THAT WE GET NEEDED THERAPIES TO THE PUBLIC FASTER WHEN
THE FDA AN SCIENCE HAS DETERMINED THAT YOU DON'T NEED TO GO THROUGH THE
MORE EXPENSIVE, THE MORE ROE, ROBUST AN THE MORE TIME CONSUMING PROCESS THAT IS
INVOLVED IN PREMARKET APPROVAL. JUSTICE WAINER APTER: DOES
THAT APPLY ALSO WHEN YOU'RE ARGUING THAT THE PREDICATE DEVICE WAS USE FOR
SALE BEFORE 1976 OR WAS THAT ONLY FOR DEVICES SOLD AFTER 1976 THAT THEY HAVE A
FINDING OF SAFETY AN EFFECTIVENESS. DANIEL B. ROGERS: YOUR HONOR,
IT PRIMARILY IS THE LATTER. IF YOU LOOK AT WHAT THE FDA HAS
SAID, THEY'RE PRETTY MUCH DONE WITH THAT GRANDFATHERED EXCEPTION. THEY'VE
GONE THROUGH THEIR RECLASSIFICATION PROCESS OF ALL OF THOSE DEVICES. I THINK BY
A COUPLE YEARS AGO MAYBE THERE WERE ONLY 25 LEFT AN NOW THEY ARE PRETTY
MUCH DONE SO THAT REALLY ISN'T PART OF THE 510(K) PROCESS EVEN TODAY.
JUSTICE WAINER APTER: DOES THAT EXPLAIN THEN THE STATEMENTS FROM THE SUPREME COURT
IN LOHR AND ROOEG GALLON FROM THE 1990S TALKING ABOUT AT HOW IN BOTH OF
THOSE IN ROOEG THEY KROOIT BACK TO LOHR BUT IN LOHR THEY WERE TALKING ABOUT A CASE
THAT HAD BEEN SETTLED PRE1976 THEY SAID THIS HAS ABSOLUTELY NOTHING TO DO WITH
SAFETY, THIS TAKES 20 HOURS, IT IS NO BIG DEAL IT IS ABOUT BEING ABLE TO
SELL THE DEVICE SO SO YOU CAN CON PEET WITH SOMEONE. DANIEL B.
ROGERS: THAT WAS PARTICULARLY FOR THAT PURPOSE AND THAT IS NOT WHAT WE'RE TALKING
ABOUT HERE TODAY. THAT IS NOT THE 510(K) PROCESS THAT EXISTS NOW THAT WAS
APPLICABLE TO THE BARD DOVE VICE ES. IT IS NOT THE 510(K) PROCESS THAT EXISTS
POST THE 1990 SAFE MEDICAL DEVICE AMENDMENTS. THE 510(K) PROCESS AS IT
EXISTS TODAY IS FOT MERELY 20 MINUTES. I MEAN -- OR 20 PAGES. YOU
HAVE FWOT THE STATISTICS FROM THE FDA TELLING YOU THAT THE CURRENT 510(K)
SUBMISSIONS I THINK ARE 24 TIMES MORE ROBUST THAN THEY WERE BACK THEN. EVEN
AT THE TIME OF THIS PARTICULAR 510(K) SUBMISSIONS I THINK THEY WERE FIVE OR SIX
TIMES MORE ROBUST, BUT THE AVERAGE REVIEW TIME WAS EXTENDED OUT MORE SUBSTANTIALLY
BECAUSE 'THEY ARE GOING THROUGH A MORE ROBUST PROCESS WITH THE CURRENT 510(K)
CLEARANCE PROCESS, THERE IS NO LONGER THAT ISSUE TO THE PACEMAKER IN LOHR.
THERE ARE THREE POINTS THAT WE WOULD LIKE TO EMPHASIZE FOR THE COURT TODAY.
THE FIRST IS THAT THIS EVIDENCE OF GOVERNMENTAL STANDARDS
REGULAR LATH CONDUCT HAS HISTORY TORLLY ALWAYS BEEN ADMISSIBLE. THIS PARTICULAR
PELVIC MESH LITTLE GROUP OF CASES IS KIND OF THE ABERRATION OF THE RULE.
THIS IS EVIDENCE THAT HAS ALWAYS BEEN ADMISSIBLE. IF YOU LOOK AT THE STATUTES
IT SAYS THAT IT IS ADMISSIBLE APRIL THERE IS ONLY THIS KIND OF ONE POCKET
OF CASES, WHY IT HASN'T AN THE APPELLATE TWIGS IN THIS CASE IS CORRECTLY RECOGNIZING
WHY THIS ONE IS ADMISSIBLE ACTUALLY IN THESE PARTICULAR INSTANCES AN WHY THIS
EVIDENCE HAS HISTORILY BEEN ADMISSIBLE PROVES TRUE EVEN IN THE PELVIC MESH CONTEXT
EVEN IF YOU LOOK OUTSIDE OF WHAT JUDGE GOODWIN WIN AND THE MDL HELD THAT WAS
AFFIRMED BY AN A COUPLE COURTS OF APPEAL, THERE ARE MANY, MANY JUDGES THAT ARE LOOKING
AT THE EXACT SAME ISSUE AND COMING OUT THE OTHER WAY FOR GOOD REASON.
JUSTICE WAINER APTER: HOW MANY OF THOSE FEDERAL CASES RELIED ON LOHR
AND ROOEG AND THE STATEMENTS IN THEM THAT 510(K) HAS NOTHING TO DO WITH SAFETY.
IT'S NOT ABOUT SAFETY AN EFFECTIVENESS AT ALL, IS A RUBBER STAMP FOR A DEVICE THAT
YOU SHOULD BE ABLE TO SELL. QUICKLY. DANIEL B.
ROGERS: THAT IS KIND OF THE BEDROCK OF THE VAST MAJORITY OF THOSE OPINIONS IF NOT
ALL OF THOSE OPINIONS AN CERTAINLY WITH RESPECT TO JUDGE GOODWIN'S OPINION
COMING OUT OF THE PUBLIC MESH MDL HE IS RELYING UPON LOHR. IF YOU LOOK AT THE
CIRCUIT COURT OPINIONS FROM THE 4TH CIRCUIT AS WELL AS THE 11TH CIRCUIT
THEY ARE RELYING ON THE STATEMENT IN LOHR, AS WELL. AS MY COLLEAGUE
NOTED BEFORE IF YOU LOOK AT THE 11TH CIRCUIT OPINION, THEY EVEN SAY HEY THIS WHOLE
THING ABOUT WHETHER OR NOT YOU'RE LOOKING AT A NONGRANDFATHERED DEVICE THAT
HAS ACTUALLY GONE THROUGH A SAFETY PROFILE, THAT'S NOT EVEN THE ISSUE THAT WAS
PRESENT BEFORE US TO THE BECAUSE THAT WAS NOT PRESENTED TO THE MD D JUDGE,
THAT'S A FOOTNOTE IN THE BLANK OPINION. THE SECOND REASON WE
WANT TO EMPHASIZE IS THAT GOVERNMENT STANDARD AT ISSUE HERE, PARTICULARLY
510(K) CLEARANCE IS HIGHLY RELEVANT BECAUSE IT REGULATES HOW A MANUFACTURER DOOINS
AND WARNS ABOUT ITS PRODUCTS. THEREFORE, IT IS HIGHLY RELEVANT TO
THE REASONABLE STANDARD THAT IS INCORPORATED BOTH IN NORTH CAROLINA
AND IN NEW JERSEY LAW. CLEARANCE IS A DETERMINATION BY THE FDA, A
STATUTORY, A REGULATORY INTERPRETATION THAT THERE IS REASONABLE ASSURANCE
OF SAFETY AN EFFECTIVENESS. THE THIRD POINT WE WANT TO EMPHASIZE ARE
THE SIGNIFICANT POLICY REASONS THAT JUSTIFY THIS EVIDENCE'S ADMISSION.
IT ENCOURAGES MANUFACTURERS TO CONTINUE USING THE PATHWAY THAT CONGRESS AND THE
FDA HAS DETERMINED IS BEST FOR PUBLIC HEALTH. YOU GET IN VOE
VAT I HAVE LIFE CHANGING THEY WERE PIECE TO PATIENT QUICKER AND MORE EFFICIENTLY.
YOU WOULD DO THAT WHILE STILL PROVIDING REASONABLE ASSURANCE OF SAFETY
AN EFFECTIVENESS BECAUSE THE SCIENCE HAS SHOWN YOU DON'T NEED TO GO THROUGH THE
PMA PROCESS. NEW JERSEY HAS A PROFOUND PUBLIC INTEREST IN DEVELOPING
THESE TYPES OF NEW PRODUCTS AN PROMOTING AN SAFEGUARDING THE LIFE SCIENCES INDUSTRIES.
NOW, IF YOU LOOK FOR EXAMPLE, AT THE U.S. SUPREME COURT'S OPINION
IN BUCK MAN, THEY SPECIFICALLY TALK ABOUT THE TWO DIFFERENT MECHANISMS THAT GO
ABOUT AND THEY HAVE A PASSAGE THAT I THINK IS IMPORTANT AND APPEARS UPON
THIS ISSUE BECAUSE IT TALKS ABOUT HOW IN THOSE INSTANCES WHEN YUR EE SAYING THAT
THE MANUFACTURER SHOULD HAVE DONE MORE THAN WHAT THE 510(K) REQUIRED AND
YOU'RE SAYING YOU SHOULD HAVE GONE THROUGH THESE EXTRA PROCESS WHAT IS SUPREME COURT
COURTED NOTE WAS THE APPLICANT WOULD HAVE AN INCENTIVE TO SUBMIT A DEL LUJ OF
INFORMATION THAT THE EXPERTS AT THE FDA SAY WE DON'T WANT AND WE DON'T NEED
BECAUSE YOU'RE GOING TO TAKE UP SO MUCH MORE OF OUR TIME LOOKING AT THINGS WE DON'T
NEED SO, THAT WE'RE NOT GOING TO BE ABLE TO GET THOSE LIFE SAVING TECHNOLOGIES
OUT OH THE MARKET QUICKER THAT'S WHY THEY HAVE THIS 510(K) PROCESS PROCESS TO MAKE
SURE WHAT THEY ARE DOING IS APPROPRIATE FOR THE PARTICULAR CASE AND THAT
IS WHAT IS IMPORTANT THAT WE NEED TO ENSURE THAT WHEN MANUFACTURERS USE THAT 510(K)
PROCESS THAT WE DON'T DIS INCENTIVIZE THEM FROM USING THAT PROCESS BY EXCLUDING
IT FROM EVIDENCE AND ALLOWING THE JURIES TO HEAR A HALF BAKED STORY TO JUDGE CONDUCT,
DIVORCED FROM THE REGULATIONS AND THE CHECKLIST THAT GUIDEDED THAT CONDUCT.
THIS EVIDENCE IS HIGHLY ADMISSIBLE IN THIS CASE AN IN ALL OF
CASES THAT JUDGE THE REASONABLENESS OF CONDUCT SO WE WOULD ENCOURAGE THE COURT
TO AFFIRM THE PAP DIVISION'S RULINGS. THE COURT: THANK YOU,
MR. ROGERS. MR. COHEN. CHARLES W. COHEN: YOUR
HONORS, GIVEN THAT I AM THE FIFTH ADVOCATE YOU'VE HEARD FROM TODAY I AM TRYING
TO LIMIT TO A COUPLE OF POINTS, I WOULD LIKE TO TOUCH ON THE ADMISSIBILITY ISSUE
AN THE PUNITIVE DAMAGES ISSUE. ON THE ADMISSIBILITY ISSUE,
PERHAPS A POINT OF CLARIFICATION COULD HELP US HERE. WE'RE TALKING ABOUT
REGULATORY COMPLIANCE EVIDENCE. REGULATORY COMPLIANCE EVIDENCE COMES IN REGULARLY
IN PRODUCTS LIABILITY CASES SO WHY ARE WE HERE TALKING ABOUT SHOULD WE BE
LEGITIMATE IN REGULATORY COMPLIANCE EVIDENCE AND THE REASON IS BECAUSE THERE HAS BEEN
A FUNDAMENTAL MISUNDERSTANDING OF 510(K) THAT HAS KIND OF STARTED A NUMBER
OF YEARS AGO AND JUST CARRIED FORWARD. THE REASON IS THIS: THE 510(K)
PROCESS CAME IN TO EFFECT IN 1976 WITH THE MEDICAL DEVICES ACT. BEFORE
THEN, THERE WAS NO REGULATION WHATSOEVER. THE ACT SAYS EVERY DEVICE IS GOING TO BE
IN CLASS III AND REQUIRING A PREMARKET APPROVAL -- APPLICATION APPROVAL IN
ORDER TO BE SOLD UNLESS THE FDA CLASSIFIES IT INTO CLASS I OR CLASS II.
ON DAY 1, THERE ARE ZERO DEVICES CLASSIFIED INTO CLASS I OR CLASS II. BY
DEFINITION, EVERYTHING IS GOING TO BE CLASS III. BUT CONGRESS SAID, IT'S GOING
TO TAKE THE FDA A LONG TIME TO CLASSIFY THOUSANDS OF DEVICES AND WHAT ARE
WE GOING TO DO NOW? AND WHAT WE'RE GOING TO DO IS WE'RE GOING TO
HAVE A GRANDFATHERING PROVISION AN WE'RE GOING TO SAY, LOOK, IF THE PRODUCT
WAS ALREADY ON THE MARKET BEFORE THIS NEW LAW, YOU CAN KEEP SELLING IT BECAUSE
OTHERWISE ALL MEDICAL DEVICES ARE GOING TO HAVE TO COME OFF THE MARKET ON
DAY 1 AND WE'RE GOING TO HAVE TO WAIT HOWEVER LONG IT TAKES THE FDA TO GET THROUGH
EVERY SINGLE DEVICE. THEN, CONGRESS, SAID, WAIT A MINUTE, IF WE
DO THAT THEN THE PEOPLE WHO ON THE DAY BEFORE THE STATUTE ARE SELLING THE
DEVICE, THEY GET A MONOPOLY ON IT. SO THAT'S TERRIBLE FOR CONSUMERS.
WHAT WE'RE GOING TO DO IS IF IT'S SUBSTANTIALLY EQUIVALENT,
THEN YOU CAN ALSO SELL IT. THIS IS AN EXCEPTION TO CLASS III PREMARKET
APPROVAL. WHAT WE'RE TALKING ABOUT TODD HINDS FOR THE STATE CASE, ALTHOUGH
IT HAS THE SAME NUMBER, 510(K) HAS NOTHING TO DO WITH A CLASS 35 EX CLASS III EXCEPTION
PROCESS, THE GRANDFATHERING PROCESS WE CALL IT THE TRANSITIONING PROCESS.
WHY IS THAT? IT'S BECAUSE WHEN YUR EE GRANDFATHERED
IT'S BEFORE THE STATUTE, BEFORE THE FDA DID ANYTHING. FOR CLASS
II, THE KEY DEFENSE IS THAT THE FDA DID DO THE SAFETY ANALYSIS THAT CONGRESS TOLD
IT TO DO. THE STANDARD FOR MEDICAL DEVICE WHETHER YOU'RE
CLASS I, CLASS II OR CLASS III IS A REASONABLE ASSURANCE OF SAFETY AN EFFICACY.
CONGRESS DECIDED THAT IF YOU'RE A CLASS III DRUG, THE WAY THAT
YOU GET REASONABLE ASSURANCE OF SAFETY AN EFFICACY IS YOU FWOE THROUGH THE PMA
PROCESS AN SO ABSOLUTELY, WHEN THE U.S. SUPREME COURT IN MET TRON NICK VERSUS
LOHR SAID FOR A CLASS III PRODUCT, 510(K) IS AS EXCEPTION, IT WAS.
BUT FOR A CLASS II DEVICE, THE WAY THE FDA HAS GOTTEN TO A FINDING OF REASONABLE
SAFETY AN EFFECTIVENESS IS THROUGH WHAT A NUMBER OF PEOPLE HERE SEEM TO
THINK IS A CUMBERSOME PROCESS AN WHICH THE PLAINTIFFS COMPLAIN ABOUT, BUT WHICH
WE RESPECTFULLY SUBMIT IS THE CHOICE THAT CONGRESS MADE AND IF THERE ARE
COMPLAINTS ABOUT THAT, THAT SHOULD BE MADE TO CONGRESS, WHAT DID CONGRESS DECIDE
FOR CLASS II SHOWS A REASONABLE ASSURANCE OF SAFETY AN EFFICACY. THEY SAID, HERE
IS WHETHER IS HERE IS WHAT IS FWOEG TO HAPPEN, WE'RE GOING TO TAKE A DEVICE
TYPE, IN THIS CASE, SURGICAL MESH. WE'RE GOING TO HAVE EXPERT DOCTORS REVIEW THAT
DEVICE TYPE AN THEY'RE GOING TO DECIDE DOES IT NEED TO BE IN CLASS III OR
DOES IT NEED TO BE IN CLASS I OR 2. HERE, SURGICAL MESH WENT THROUGH
THAT PROCESS, THREE DIFFERENT PANELS OF DOCTORS ACTUALLY WENT THROUGH THAT
DEVICE TYPE AND SPECIFICALLY FOUND, AS THEY MUST HAVE, THAT A PMA WAS NOT REQUIRED
AND NOT APPROPRIATE FOR THIS DEVICE TYPE. HAD IT BEEN REQUIRED
TO HAVE A PMA, THEY MUST HAVE PUT IT IN CLASS III. IN FACT
IN THE FEDERAL REGISTERS IN 1982 AND 1988, YOU WILL SEE STATEMENTS TO THE EFFECT
OF EVEN THOUGH THIS IS IMPLANTED IN THE HUMAN BODY WE HAVE DETERMINED THE
PMA IS NOT REQUIRED. SO, I THINK THE SOURCE OF A LOT OF THIS
CONFUSION IS THAT EVERYBODY SAYS 510(K) AND ADDING TO THE COURT'S CONFUSION WE CALLED
IT TRANSITIONAL, SOMEONE CALLED IT GRANDFATHER. IN THIS SENSE IT IS MOST
TECHNICALLY ARE WE TALKING ABOUT THE 510(K) PROCESS FOR A CLASS III DEVICE WHICH
IS AN EXCEPTION TO PMA OR ARE WE TALKING ABOUT 510(K) FOR A CLASS II DEVICE WHICH IS
NOT AT ALL AN EXCEPTION. IT LITERALLY IS EX SAKTLY WHAT CONGRESS SAID,
WHICH FWIFS YOU REASONABLE SAFETY AN EFFICACY BECAUSE THE PANELS HAVE DECIDED THE
DEVICE TYPE IS REASONABLY SAFE AN EFFECTIVE, THOSE DEVICES THAT THEY
LOOKED AT GET CLASSIFIED INTO CLASS II AND THEN THIS ONE IS SUBSTANTIALLY EQUIVALENT.
SUBSTANTIALLY EQUIVALENT BECAUSE IT EITHER HAS THE SAME TECHNICAL SPECIFICATION
OR IF IT HAS DIFFERENT TECHNICAL SPECIFICATIONSING, THE DIFFERENCES DO
NOT MAKE IT LESS SAFE OR EFFECTIVE. SO IS IT THE MOST STRAIGHTFORWARD
SAFETY ANALYSIS THAT WE HAVE EVER SEEN? OF COURSE NOT.
IS IT THE CONGRESSIONALLY MANDATED PROCESS? HAD. IT
IS. AND, THEREFORE, IT'S REGULATORY COMPLAINS ON THE EVENT DARE RESTANDARD OF
COURSE IT NEEDS TO COP COME IN AN IN CHOICE OF 403 THE, WE ARE RESPECTFULLY
SUBMITTING THAT THIS COURT SHOULD DECLARE THAT THE EVIDENCE IS RELEVANT AND THE
TYPES OF ARGUMENTS THE PLAINTIFF HAS MADE IS NOT SUFFICIENT TO HAVE IT BE
INADMISSIBLE EVEN ON A 403 ANALYSIS. THE COURT: WOULD YOU LIKE TO
MOVE ON FROM THAT. CHARLES W. COHEN: FROM MANY OF THE REASONS
WHICH THE COURT HAS ALREADY ACKNOWLEDGED WHICH IS HOW IMPORTANT IT IS FOR
THE JURY TO UNDERSTAND WHY YOU DID SOMETHING AN TO NOT BE ABLE TO GIVE ONLY HALF
THE STORY, RECOGNIZING MY TIME IF THERE ARE QUESTIONS ON THAT I WILL TURN
TO THOSE OTHERWISE I WANT TO TURN TO THE PUNITIVE DAMAGES STATUTE.
THE COURT: PLEASE. CHARLES W. COHEN: ON THE PUNITIVE DAMAGES
STATUTE, LET'S START BACK AT SQUARE 1. WHAT IS THE LEGISLATURE TRYING
TO DO? THE LUFR IS TRYING TO BALANCE AND IN SOME REGARDS
BALANCE IN FAVOR OF FFR MANUFACTURERS WHAT KIND OF DAMAGES CAN BE ACCESSED AGAINST
THEM. THE LEGISLATURE SAID OKAY, WE'RE GOING TO HAVE COMPENSATORY
DAMAGES, BUT WE'RE NOT GOING TO HAVE PUNITIVE DAMAGES FOR DRUG AN MEDICAL DEVICE
MANUFACTURERS. AND WHY? WE ALREADY KNOW
THAT PUNITIVE DAMAGES ARE AN EXCEPTIONAL REMEDY. THEY REQUIRE
A STATE OF MIND. ACTUAL MALICE, WFL WILLFUL AND WANTON CONDUCT.
THE LEGISLATURE IS SAYING LOOK, IF YOU FOLLOW THE RULES THE FDA GIVES YOU, YOU
CAN'T GIVE, HAVE THAT MENTAL INTENT. IT'S NOT APPROPRIATE TO HAVE PUNITIVE
DAMAGES IN THAT CASE. SO THEY WROTE A STATUTE AN THEY TRIED TO DO
THAT. AND, AS WAS POINTED OUT BY THIS COURT, THEY WEREN'T THINKING, OH,
ACTUALLY WE'RE GOING TO IMMUNIZE 2 PERCENT OF THE MEDICAL DEVICES AN WE'RE NOT
GOING TO IMMUNIZE 98 PERCENT OF THEM. JUSTICE WAINER APTER:
WOULDN'T IT ACTUALLY BE 1 HUNDRED PERCENT BECAUSE ONCE YOU HAVE THE PREMARKET
APPROVAL THEN ALL THE TORT CLAIMS ARE ALREADY PREEMPTED SO THERE ARE NO
CASES AGAINST A DECEIVE, DID HE HAVE VIESZ THAT GOT PREMARKS APPROVAL?
CHARLES W. COHEN: SO BECAUSE OF THE EXPRESS PREEMGS PROVISION IN THE ACT, THE
SUPREME COURT HAS HELD FOR THE MOST PART THEY ARE PREEMPTED. SOME PARALLEL
CLAIMS ARE ALLOWED TO GO FORWARD. IT GETS IN KREDLY COMPLICATED.
IF IT WENT FOR 100, IF IT WENT FOR 98 PERCENT, IF IT WENT FOR 82 PERCENT, I BELIEVE
THAT WAS IN OUR APPENDIX, THE SAME THING. IT DOES NLTD MAKE ANY SENSE FOR
THE LEGISLATURE TO SAY WE WANT TO FIND THAT MANUFACTURERS WHO ARE COMPLYING WITH
THE RULES THAT THEY ARE GIVEN DON'T HAVE THE REQUISITE INTENT FOR PUNITIVE
DAMAGES AN THEN DRAW UNBELIEVABLE BLEE HYPOTHETICAL MER TECHNICAL
DISTINCTIONS BY THE METHOD BY WHICH THE FDA ACTUALLY GOES ABOUT LOOKING AT THOSE
THINGS. THE MOST IMPORTANT ASPECT OF THIS I THINK IS TO ANSWER
SOME QUESTIONS THAT MR. KOTT WAS GIVEN, WHICH WAS, ACTUALLY, WE SHOULD START, AS
WE ALWAYS DO WITH THE LANGUAGE OF THE STATUTE AN WE LOOK AT LICENSE -- PLEA
MARKET APPROVAL OR LICENSURE. THERE WERE QUESTIONS ABOUT LOOK, IF IT
SAYS THE SUBJECT OF PREMARKET APPROVAL OR LICENSURE UNDERSTAND THE FD C
A DOESN'T THAT MEAN IT'S TECHNICAL TERM UNDER THAT ACT AND WE RESPECTFULLY SMT
SUBMIT, NO IT ISN'T FOR TWO REASONS. FIRST, AS A MATTER OF
STATUTORY CONSTRUCTION, WHEN WE LOOK TO THE LAST SENTENCE AND IT TELLS YOU
IF IT IS A DRUG, DEVICE, FOOD OR FOOD ADD DID IT D-TIFR GO GET THE DEFINITION FROM THE
F D C A. IT DOESN'T SAY THAT WITH APPROVAL OR LICENSURE.
THIS MAKES SENSE BECAUSE WHEN YOU'RE THINKING ABOUT WHAT THE LEGISLATURE IS TRYING
TO DO, WHICH IS DECLARE THAT THE MANUFACTURERS WOULD FOLLOW THE RULES
THAT THE THEY ARE GIVEN, THEN WE USE THE ORDINARY MEANINGS. THE
COURT: YOU ARE TELLING US YOU AGREE COMPLETELY WITH THE FINE ARGUMENT THAT MR.
KOTT MADE SO I ENCOURAGE YOU TO MOVE ON BECAUSE WE'RE BEYOND TEN MINUTES
NOW. CHARLES W. COHEN: THE REASON IS JUST TO SAY THAT THE
PLAIN MEANING GOES IN THE SQUARE BRACKETS WHEN YOU READ THAT FIRST SENTENCE SO
THE ANSWER IS YOU READ PREMARKET APPROVAL OR LICENSURE PLAIN MEANING BEFORE AND
AFTER AND THAT'S IT. THE COURT: UNDERSTOOD.
CHARLES W. COHEN: THANK YOU, YOUR HONOR. THE COURT: MR. KURTS, KURTS
KURTS GOOD AFTERNOON, MAY IT MREEZ THE COURT ON BEHALF OF N J C J I I
RESPECTFULLY ASK THIS COURT TO REVERSE THE SUPREME COURT'S HOLDING ON IS THE SECTION
510(K) ARGUMENTS THE N J C I DOOMENTS THE ARGUMENTS BACK TO 510(K) AND SO I WILL
FOCUS ON POLICY AND LEGISLATIVE INTENT ISSUES. AS THIS COURT HAS UN
EQUIVOCALLY EXPLAINED AND AS LEGISLATIVE HISTORY UNEQUIVOCALLY SUPPORTS THE P
PLA WAS MADE TO, IN. INTERPRETATION TO FILL ITS PURPOSE AN AS
JUSTICE WAYNE WAS POINTING OUT OR WAS QUESTIONING THE APPELLATE DIVISION'S
INTERPRETATION WOULD BE TO RENDER IT ESSENTIAL 98 PERCENT GO THROUGH 510(K), THE
REST THROUGH PMA, BUT THERE IS USUALLY PREEMGS SO IT WOULD HAVE ALMOST NO
PRACTICAL EFFECT. TO COUNTER THIS, PLAINTIFF SAID, WELL, THE
LEGISLATURE COULDN'T HAVE INTENDED TO GIVE BLANKET IMMUNITY FROM PUNITIVE DAMAGES
TO MEDICAL DEVICE MANUFACTURERS THAT WOULDN'T BE A REBALANCING, THAT WOULD
BE TILTING THE SCALES ALL THE WAY IN FAVOR OF THE MANUFACTURERS, BUT THAT OVERLOOK
S THAT THE PRODUCTS LIABILITY ACT LEFT UNCAPPED NONECONOMIC DAMAGES SUCH AS
EMOTIONAL DISTRESS, PAIN AND SUFFERING, THAT MANY OTHER JURISDICTIONS HAVE ACTED
TO CAP. INDEED, HERE, THE JURY AWARDED, 23 MILLION IN
COMPENSATORY DAMAGES TO THE PLAINTIFF. ALMOST ALL OF WHICH WAS NONECONOMIC, AS WELL AS
10 MILLION IN LOSS OF CON SORTED YUM DAMAGES TO THE PLAINTIFF'S HUSBAND FOR A
TOTAL OF $33 MILLION NONECONOMIC, NONPUNITIVE DAMAGES.
WHILE, EXCESSIVE ON THE FACTS OF THIS CASE, THE AWARD SHOWS THAT EVEN WITHOUT PUNITIVE
DAMAGE IN THE EQUATION, THERE IS STILL A BALANCE SO ESSENTIALLY WRITING
SECTION 5 OUT OF THE PL A FOR MEDICAL DEVICES AS THE APPELLATE DIVISION HAS DONE
WOULD UPSET THE BALANCE BETWEEN COMPENSATORY AND PUNITIVE DAMAGES THAT THE
LEGISLATURE HAS CHOSEN IN THIS CASE. FURTHER, THE APPELLATE DIVISION'S
HOLDING WOULD CREATE AN ANOMALOUS RESULT WHERE ONLY THE MOST DANGEROUS CLASS
III DEVICES ARE ENTITLED TO PUNITIVE DAMAGES PROTECTION AND THAT COULDN'T HAVE
BEEN SOMETHING THE LEGISLATURE INTENDED BECAUSE AS A GENERAL MATTER WITHIN
THE PUNITIVE DAMAGES STATUTORY SCHEME THE LIKELIHOOD OF CAUSING SUBSTANTIALLY HARM
IS CONSIDERED THE A FACTOR IN IMPOSING PUNITIVE DAMAGES. SO
CLASS III DEVICES ARE GENERALLY DID HE HAVE VIALS ES THAT SUPPORT LIFE LIKE A PACE
MAKER SO WHEN THEY FAIL CATASTROPHIC CONSEQUENCES, DEATH, SERIOUS HARM
OFTEN RESULT, MUCH LESS SO WITH CLASS II DEVICES THE TYPICAL EXAMPLES OF CLASS II
DEVICES ELECTRONIC WHEEL CHAIRS, PREGNANCY TESTS, THINGSES OF THAT NATURE. THEY
ARE MUCH SAFER AS A CLASS OF DEVICES SO IT WOULDN'T MAKE SENSE FOR THE
LEGISLATURE TO DLIEN TO EXTEND PUNITIVE DAMAGES PROTECTIONS TO LESS SAFER DEVICES
JUST BECAUSE CONGRESS AND THE FDA MADE A POLICY DECISION TO PROVIDE A DIFFERENT
PATH FOR THESE DEVICE SESSION THAT REFLECTS THEIR SAFER NATURE.
ALSO, THE APPELLATE DIVISION'S RULING WOULD CREATE TENSION BETWEEN NEW JERSEY LAW
AND THE CONGRESSIONAL GOALS OF 510(K). THE PROCESS IS DESIGNED TO PROVIDE
A MORE TIME EFFICIENT, COST EFFICIENT PATH TO MARKET FOR D-DEVICES SO CONSUMERS
HAVE PROMPT AN MORE COST EFFICIENT ACCESS TO THEM. IT IS THE
ONLY PATH TO MARKET FOR CLASS II DEVICES THAT HAVE EXISTING PREDICATE DEVICES ON
THE MARKET. IT'S NOT A SHORTCUT. THE APPELLATE DIVISION'S
HOLDING EFFECTIVELY PUTS THE MRA PLA AT ODDS WITH CONGRESS AND TREATS IT AS A
SHORTCUT THAT DOES NOT ADEQUATELY PROTECT SAFETY. 510(K) IS ABOUT
SAFETY THROUGH EQUIVALENCE. IN ENACTING THE PLA, THE LEGISLATURE DID
NOT INTEND TO DENIGRATE CONGRESS'S JUDGMENT. THEY INTENDED TO DEFER TO
CONGRESS AND THE FDA BY REMOVING PUNITIVE DAMAGES PROTECTIONS FOR THOSE WHO PLAY
BY THE FDA'S RULES. IT'S NOT JUST A CERTAIN SET OF RULES AS
THE PAST BILL MEMBER, SECTION 5 DESCRIBES, QUOTE, PROTECTIONS GIVEN TO
PHARMACEUTICAL COMPANIES WHO PROPERLY COMPLY WITH FDA RULES AN REGULATIONS, WHO
PLAY BY THE FDA'S RULES SO FOR THESE REASONS, IN SUM, LITIGATION KOGSS
INCLUDING AVAILABILITY OF PUNITIVE DAMAGES ARE ULTIMATELY REFLECTED IN THE PROOIS
PRICE OF MEDICAL DAMAGES AN PUNITIVE DAMAGE CAN DIS INCENTIVE ADVISE
PRODUCTION, CAUSE SUPPLY ISSUES. THE PLA SOUGHT TO SHARPLY NARROW ISSUES
TO KEEP DEVICE PRICES DOWN. SO N J C I, IN ACCORDANCE WITH
THAT LEGISLATIVE INTENT AND HOLD THAT IT IS APPLIES WITH RESPECT TO DEVICES
THAT ADHERE TO REGULATION THAT IS ACTUALLY DEFINE THESE TERMS AND MAKE CLEAR THAT THE
PRODUCT LIABILITY ABILITY DECISION WAS BASED ON THE RIG OR OF A SAFETY REVIEW. I'M GOING
TO START FROM THE POEM. FROM 21USC A SECTION 36 EAR OH FFF, THE TERM GRASS AGE INTESTINE
RECOGNIZES SAVE AND EFFECTIVE MEANS GENERALLY RECOGNIZED AMONG EXPERT QUALIFIED BY
SCIENTIFIC TRAINING AND EXPERIENCE TO EVALUATE THE SAFETY AND THE EFFECTIVENESS OF DRUGS,
THE SAFE AND EFFECTIVE USE UNDER THE CONDITIONS PRESCRIBED RECOMMENDED OR SUGGESTED UNDER THE
LABELING OF A DRUG AS DESCRIBED IN SECTION 321 P OF THIS FILE. AS WE WROTE OUT IN OUR
PROOF THIS IS FOR OVER-THE-COUNTER DRUGS, OVER-THE-COUNTER WHERE IS SUN SCREEN, IT'S
A BROAD SECTION OF PRODUCTS AND IT SPECIFICALLY DEFINED. THAT IS NOT 510(K). LICENSURE
IS SPECIFICALLY DEFINED AS RELATING TO BIOLOGICAL PRODUCTS AND IF YOU LOOK AT 21USC A
SECTION 379G AS WE RIGHTED IN OUR BRIEF YOU'LL SEE THERE ARE A WHOLE HOST OF SAFETY STEPS
THAT MUST BE TAKEN MR. JAO: THE LEGISLATURE USED THAT,. JUDGE
ACCURSO: THAT HAPPEN WASN'T IN EXISTENCE IN 119 MEMBERSHIP. I GOT IT RIGHT THE
FIRST TIME. WHEN THE PLA CAME INTO EFFECT, RIGHT. ADAM M. SLATER: I'M
LOOKING AT THE LEGISLATIVE HISTORY GOING BACK AND I'M NOT GOING TO PRETEND
TO KNOW EXACTLY THE SPECIFICS OF WHAT WAS ADDED A AT THAT POINT. THE LEGISLATURE
HISTORY FOR THE STATUTE DOES BACK TO LOOKS LIKE 1938. JUDGE ACCURSO: YOU'RE
TALKING BY LODGE EXCULPATORY, OUR PLA WAS 19 YECH. THAT BY LOGIC, YOU'RE SAYING
WE SHOULD USE LICENSURE WITH BY LOGIC, THE LEGISLATURE COULDN'T HAVE, RIGHT.
ADAM M. SLATER: I BELIEVE THAT LICENSURE WAS A TERM OF ART AT THE TIME
AND IT'S CERTAINLY NOT A CONCEPT OF KOA LOCK WE WILL ANYTHING THAT YOU SELL.
IF IT'S ANYTHING THAT YOU SELL THEY WOULD SAY ANY PRODUCT REGULATED BY THE
FDA. APPEAR FINALLY I'M NOT GOING TO GET INTO THE PRE MARKET APPROVAL I THINK WE'VE
ARGUED THAT QUITE A BIT SO THAT'S WHAT I HAVE TO SAY ABOUT THAT. CHIEF
JUSTICE RABNER: BEFORE YOU MOVE BEYOND THAT. WE HEARD AN ARGUMENT JUST MINUTING A
THERE'S SORT OF A BROADER ARGUMENT ABOUT 510(K) AND ALSO A NARROW ARGUMENT THAT
THIS 510(K) PROCESS REACHED THE CONCLUSION THAT IT WAS SAFE AND EFFECTIVE. CAN YOU
RESPOND TO THAT. ADAM M. SLATER: YES, AS EVERY COURT THAT'S LOOKED
AT IT INCLUDING THE COURT THAT YOU'RE REVIEWING, EVERYONE HAS ACTUALLY
CONCLUDED THAT'S NOT TRUE. IN AN ESSENCE WHAT THE DEFENSE AND THE AMICI ON THEIR
SIDE ARE ARGUING FOR IS A COMPLETE RECAP LEGISLATION OF THE DEFINITION THAT'S
BEEN ACCEPTED IN THE COURTS. SO THERE'S REALLY NO TRANSACTION TO THAT. THEY'RE
LITERALLY ASKING TO TAKE A FRESH NEW LOOK AND SAYING IS 510(K) ACCORDING TO THIS
COURT DIFFERENT ALREADY OTHER COURT -- JUSTICE WAINER APTER: WOULD IT
BE DIFFERENT FROM WHAT THE FDA SAYS. I THINK THE 510(K) PROGRAM EVALUATING
THE SUBSTANTIAL EQUIVALENT AND PRE MARKET NOTIFICATIONS AND IT JUST TALKS ABOUT
HOW THE PRINCIPALS OF SAFETY AND EFFECTIVENESS UNDER LIE THE SUBSTANTIAL
KIND OF LENS DETERMINATION AND EVERY 510(K) REVIEW, IT SETS FORTH HOW ALTHOUGH THE
510(K) PROCESS INVOLVES A COMPARISON OF A NEW DEVICE TO A PREDICATE RATHER THAN
AN INDEPENDENT DEMONSTRATION OF THE NEW DEVICE SAFETY AND PHAKITISNESS IN BOTH
CASES FDA'S REVIEWED DECISION REFLECT A CONCERNING OF THE LEVEL OF CONTROL
NECESSARY TO PROVIDE A REASONABLE AN INSURANCE OF SAFETY AND EFFECTIVENESS. SO IT
SEEMS LIKE A LOT OF THE PRIOR COURT DECISIONS WENT BACK TO LOHR WHICH AGAIN
WASN'T TALKING ABOUT A DEVICE THAT HAD ALREADY BEEN DETERMINED THE PREDICATE
HAD ALREADY BEEN DETERMINED TO BE SAFE AND EFFECTIVE AND INSTEAD WAS REFERRING TO
THIS GRANT FATHERED PROCEEDS DOESN'T THE FDA SAY IT'S RELATED TO SAFETY AND
EFFECTIVENESS. ADAM M. SLATER: YOU JUST HAVE TO LOOK TO THE CASE FROM
THE THIRD THE CISSON COURT PECK HAD I REJECTED THAT MAYBE THE FDA HAS THESE
ASPIRATIONAL STATEMENTS IT'S NOT BINDING ON THE COURTS IT'S NOT AN ACCURATE STATEMENT
OF WHAT THE REGULATION SAYS. IT'S IN ESSENCE TRYING TO INFLATE THE REACH OF
510(K) AND THEY CORRECTLY ADDRESS THAT ARGUMENT SO I WOULD RELY ON WHAT THE
FOURTH CIRCUIT COURT OF APPEALS SAID IN EVALUATING THAT ISSUE. AND I'D LIKE TO
COME NOW JUSTICE WE KNOW EXACTLY WHAT YOU ASKED. REGAL AND LOHR ARE NOT RELEVANT
CASE. WHAT IS WHAT THE DEFENSE IS HERE SAYING. WE HAVE THREE FEDERAL COURTS
OF APPEAL THAT HAVE RECENTLY ASKED OF COUNSEL TODAY CONFIRMED THAT THOSE CASES
MARRIED DISTINCTLY AND I'LL TELL YOU WHERE. THE ANALYSIS HERE IS NOT ABOUT THE
PREDICATE PRODUCT. IT'S ABOUT HOW THE NEW PRODUCT GET TO MARKET. IT'S THE
COMPARATIVE STEP THAT'S TAKEN WITHOUT A SAFETY EVALUATION OF THE PRODUCT THAT
WE ACTUALLY TRIED THE CASE ON AND TO TAKE IT A STEP FURTHER THE REASON WHY THE
PREJUDICE AND CONFUSION OWL WEIGHS THE PROBATIVE VALUE. IF THIS COMES IN, IF THAT'S
TRUE THAT THEY WANT TO SAY WELL THERE WAS A PREDICATE PRODUCT SOME WHERE DOWN
THE LINE HAD A SAFETY REVIEW WE'RE NOW GOING TO TRY ALL THESE PREDICATE PRODUCTS
WE'RE GOING TO HAVE TO SHOW THE JURY THIS WAS A BONE PATCH AND THIS WAS FOR
A HERNIA. AND THIS TURNED OUT TO BE A TERRIBLY UNSAFE PRODUCT AND WE'RE GOING TO
HAVE TO SPEND DAYS BECAUSE THAT'S THE ONLY WAY TO FULLY PULL THIS A PART TO
SHOW WHY THE JURY SHOULDN'T CARE ABOUT THIS LIST OF PREDICATE PRODUCTS. AND
AGAIN, THE FEDERAL COURTS OF APPEALS THEY KNOW WHEN REGAL WAS AIDED. THEY KNOW
WHEN LOHR WAS DECIDED. THEY KNOW WHAT THEY RELIED ON AND THEY ALL LOOK BACK AT THE
FACT AT IT'S BASE WHAT IS 510(K) ABOUT SUBSTANTIAL KIND OF LENS. IT'S NOT
IN THIS CASE TO LOOK AND SAY WELL WAS THERE A PREDICATE TO SAY THAT PREDICATE
WAS IMAGE APRIL WHAT WE HAVE TO DO AT TRIAL TO DO. IT'S HOW WE GOT TO MARKET AS
MANY. JUSTICE SOLOMON: CAN I ASK YOU TO ADDRESS A COUPLE THINGS. MR. KOTT
MENTIONED 23 TIMES DURING THE TRIAL THERE WAS DISCUSSION OR MENTION OF LACK
OF CLINICAL TRIAL AND HE RESPONDS TO THAT BY SAYING FDA CONCLUDED THAT NO CLINICAL
TRIALS WERE REQUIRED. IS THAT WHAT THE FOOD AND DRUG ADMINISTRATION CONCLUDED OR
NOT. ADAM M. SLATER: THAT'S WHERE I WAS GOING BEFORE AND I THINK
THAT MAYBE I WASN'T BEING CLEAR. SO THAT'S THE POINT I WAS TRYING TO MAKE BEFORE
I'M GOING TO NOW LOOK DIRECTLY TO THE DOCUMENTS STARTING WITH WHAT WAS SUBMITTED
TO THE FDA BY BARD. AND IT'S IN THE A PEPTIC AT 2648 A. JUSTICE
SOLOMON: DID THE FDA CONCLUDE THAT NO CLINIC WILL A TRIALS WERE REQUIRED. ADAM M.
SLATER: TO PROVE SUBSTANTIAL KIND OF LENS. JUSTICE SOLOMON: OKAY. ADAM
M. SLATER: AND I'M TRYING TO GIVE CONTEXT TO THIS BECAUSE I WANT TO MAKE SURE IT'S
NOT MY SAY SO HERE. THIS IS WHAT BARD TOLD THE FDA WHEN THEY WERE ASKED AND IT'S ON
2648 A OF OUR PEN PARTICULARS, IS CLINICAL TESTING NEEDED,. NOT APPLICABLE.
BENCH TESTING IS ADEQUATE TO ESTABLISH SUBSTANTIAL KIND OF LENS. THAT'S WHAT
BARD TOLD THE FDA THEY MADE IT CLEAR THAT CLINICAL STUDIES THAT WOULD COME IN UNDER
THIS CONTEXT ARE ONLY TO SUBSTANTIAL KIND OF LENS. AND AS I READ TO THE COURT
BEFORE. BARD'S EXPERT IN HER REPORT SAID EVEN IF CLINICAL STUDIES HAD BEEN
DONE COMPARING THE AVAULTA TO PREDICATE DEVICES THEY WOULD NOT HAVE ANSWERED THE
QUESTIONS RAISED REGARDING TRANCE VAGINA PLACEMENT OF SURGICAL MESH FOR PROLAPSE
REPAIR BECAUSE AGAIN CLINICAL STUDIES IN THE CONTEXT OF STAPS AT KIND OF LEEPS ARE
ONLY TO COMPARE A PREDICATE PRODUCT. THAT EROSION RATES EYE NOT TO DO AN IMMEDIATE
RISK BENEFIT SO IT'S A COMPLETELY DIFFERENT ISSUE APPEAR IT WOULD BE COMPLETELY
MISLEADING TO THE JURY TO SAY WELL, THE FDA -- AND THAT'S ULTIMATELY WHAT THEY WANT
TO DO -- THERE WAS NOTHING THEY COULDN'T DO IN DEFENSE OF THIS TRIAL. THEN POINTED
TO ONE PIECE OF EVIDENCE. JUSTICE SOLOMON: I DON'T WANT TO GET I JUST
WANT AN ANSWER TO MY QUESTION. ADAM M. SLATER: THE ONLY FDA SAID IT'S INDICATE
AND TO SAY WE DIDN'T HAVE TO DO CLINICAL STUDIES. JUSTICE SOLOMON: I GOT
THAT YOU ANSWERED THE QUESTION. ADAM M. SLATER: I'M SORRY. JUSTICE
SOLOMON: THE SECOND THING THEY SAID IS THAT THEY COULD NOT GO THROUGH A PRE MARKET
PROCESS FOR THIS PRODUCT, IS THAT TRUE. ADAM M. SLATER: FOR A CLASS TWO DEVICE
THEIR INITIAL SUBMISSION IS FOUR OR 510(K). IT'S INTERESTING THE 510(K) IN
THEIR REVIEW DOCUMENTS YOU WILY REFERENCE THE FACT THAT THEY'RE SUPPOSED TO
TAKE THE LEAST BURDEN SOME APPROACH TO THE REVIEW THE ANSWER TO QUESTION IS
THEY HAVE TO START WITH THE 510(K) IF THE FDA LOOKED AT THIS SAY THIS DOESN'T QUALIFY
AS 510(K) AS IT SUBMITTED FOR EXAMPLE, I BELIEVE THAT IF THE ENTIRE PROCEDURE
HAD BEEN SUBMITTED THE FDA WOULD HAVE SAID WOULD HE THIS ISN'T SOMETHING WE'VE
LOOKED AT. JUSTICE SOLOMON: WE GET BACK TO MY ORIGINAL QUESTION WAS IS THE
PRODUCT AT ISSUE THE PELVIC MESH OR IS THE PRODUCT AT ISSUE THE ENTIRE PROCESS
WITH THE ARMS AND ALL THE OTHER STUFF. ADAM M. SLATER: AT TRIAL THE ISSUE WAS
THE ENTIRE PROCEDURE. JUSTICE SOLOMON: IS THAT A MEDICAL MALPRACTICE
CASE OR THAT A PRODUCTS LIABILITY CASE. ADAM M. SLATER: WELL IT'S INTERESTING
IT'S A PRODUCT LIABILITY CASE BECAUSE THAT'S HOW IT'S HANDLED. JUSTICE
SOLOMON: AS TO WHAT PRODUCT. ADAM M. SLATER: AS TO THE AVAULTA AND A LINE
TRANCE OPERATOR RAY TORE SYSTEMS. I WILL TELL YOU THIS IS INTELLECTUAL DISCUSSION.
JUSTICE SOLOMON: THAT IS MORE THAN PELVIC MESH. ADAM M. SLATER:
WITHOUT THE PROCEDURE THE KIT DOESN'T EXIST. THE MESH ISN'T NEEDED. THE TREATMENTS
AREN'T IMMEDIATED THEY'RE ONLY THE DELIVERY VEHICLES FOR THE PROCEDURE. THAT'S WHAT
WAS BEING SOLD THE PROCEDURE, THE SYSTEM AND THE KIT AND THE PROCEDURE. I REALLY
IT'S A LITTLE ANOMALOUS YOU SAY IT'S A PROCEDURE. I CAN TELL YOU I FOLLOWED
THE FIRST CASE IN NEW JERSEY 2008. IT'S A DISCUSSION WE HAD OVER THE YEARS
ARE THESE JUST NEGLIGENCE CASES THEY PUT ON A DANGEROUS PROCEDURE. THE COURTS HAVE
CONSISTENTLY TREATED AS A PRODUCT LIABILITY CASES I DIDN'T WANT TO BE THE FRAIL
BLAZER TO SAY HANDLE IT DIFFERENT. IT'S NOT A NEAT FIT BECAUSE IT'S NOT JUST
THE ACTUAL MEASURE. IT'S MUCH MORE THAN THAT. I CAN GIVE YOU CITATION AFTER
CITATION THEY'RE IN OUR BLAST DR. ROSENBLIT WROTE AN EXPERT THEIR ARTICLE PEAT
ROSENBLIT SAID IN THAT ARTICLE AND IT'S IN THE CROSS EXAMINATION OF THE TRANSCRIPT
THESE ARE VERY CONTROVERSIAL PROCEDURES, THERE'S A LOT OF DOUBT ABOUT THE
PROCEDURES AND THE TECHNIQUES AND MAYBE WHEN WE DO LONG TERM STUDIES PEOPLE
WILL ACTUALLY START TO HAVE CONFIDENCE IN THESE PROCEDURES. THAT'S HOW THEY'RE
DISCUSSED IN LITERATURE. YOU HEARD ABOUT EXPERIMENTAL. WHERE DID EXPERIMENTAL
COME FROM. DR. WEB EROSION RATES WHO IS OUR EXPERT. JUSTICE SOLOMON:
I DIDN'T ASK ABOUT ANY OF THAT. CHIEF JUSTICE RABNER: BUT I WANT TO GO
THERE. COMMENT IF YOU WOULD ON THE BASIC FAIRNESS ARGUMENT THAT WE'VE HEARD
THROUGHOUT THIS CASE THAT THE REFERENCES TO EXPERT AT THE REFERENCES TO LACK
OF CLINICAL TRIALS WERE UNFAIR WITHOUT THE ABILITY TO PRESENT ANY REFERENCE TO THE
510(K) PROCESS AND IF YOU WOULD TAIL THAT NOT ONLY GENERALLY BUT TO THE QUESTION
OF PUNITIVE DAMAGES. ADAM M. SLATER: BECAUSE WHEN WE TALKED ABOUT
EXPERIMENTAL IT WAS IN THE CONTEXT OF A COULD GO. AMERICAN COLLEGE OF OBJECT VISION
AND GYNECOLOGIST PROCEDURE WRITTEN IN FEBRUARY 2007 BY OUR EXPERT DOCTOR WEB
EROSION RATES THAT SAID THESE PROCEDURES ARE NEW, THEY'RE UNTESTED AND UNTIL
THEY WERE ACTUALLY CLINICAL STUDIES WITH PROPER INFORMED CONSENT THEY SHOULD BE
DEEMED EXPERIMENTAL UNTIL STUD ICE SHOW SAFETY AND EFFICACY AND THAT IT'S BETTER
THAN THE PROCEDURES THAT ARE BEING DIFFICULTIES PLACED WHICH WERE SUTURE BASED
PROCEDURES WITHOUT MESH. PARENTHETICALLY WHAT HAPPENED WAS THE INDUSTRY WENT
TO A COULD GO AND THEY WANTED TO GET THE WORD EXPERT ALLSTATE LAW REMOVED NOT
BECAUSE THEY WERE WORRIED ABOUT 510(K) BUT EXPERIMENTAL PROCEDURES AREN'T PAID FOR
BY THE INSURANCE COPS. WE HAVE THE INTERNAL DOCUMENTS FROM THE COMPANIES. THEY
IN FACT HAD A DOCUMENT AT TRIAL THEY WANTED TO PUT MY EXPERT IN CEMENT SHOES
IN RHODE ISLAND. IT'S A REALLY DOCUMENT IT'S REALLY WHAT THEY SAID NOT BECAUSE
OF 510(K) BUT BECAUSE EXPERT ALLSTATE LAW WOULD HAVE GOTTEN PROCEDURES NOT TO BE
PAID FOR. THIS AS MEDICAL SOCIETY PRACTICING BULLET CONTINUE SAYING THAT.
510(K) SAYS NOTHING ABOUT THAT. 510(K) CLINICAL STUDIES AS ADMITTED BY THERE
EXPERT AND THEIR OWN EXPERT REPORT DON'T SPEAK TO MEDICAL RISK BENEFIT. THEY
ONLY TALK TO COMPARING THIS MESH DEVICE TO A PRIOR MESH GOING BACK TO SURGICAL MESH.
JUDGE ACCURSO: WHAT ABOUT BASIC FAIRNESS. THAT'S THE QUESTION. YOU GOT
TO SAY EXPERT ALLSTATE LAW THEY DENT GET TO SAY 510(K). WE GET YOUR ARGUMENT THAT
510(K) DOESN'T WOULD TO THIS. THEY DIDN'T GET TO SAY IT AND IN TERMS OF
EXPERIMENTAL BEING OFF THE -- OFF POINT IN TERMS OF WHAT WE'RE TALKING ABOUT IN TERMS
OF THE DEVICE AND WARNINGS. ADAM M. SLATER: THAT'S NOT WHAT I'M SAYING.
EXPERIMENTAL IS OFF POINT TO 510(K) OUR EXPERT DIDN'T SAY THESE ARE EXPERIMENTAL
BECAUSE NOBODY EVER CLEARED THEM AND NOBODY EVER LOOKED AT THEM AND SOMEBODY
-- JUSTICE SOLOMON: DID YOU EVER EXPLAIN TO A JURY. ADAM M.
SLATER: IT WAS EXPLAINED IN GREAT DETAIL WHEN SHE WAS CROSS-EXAMINED. AND THEY
I'LL TELL YOU JUSTICE THEY HAD THE ABILITY TO PUT IN EVERY SINGLE STITCH OF EVIDENCE
THEY WANTED TO PUT IN TRIAL. THERE WAS ABSOLUTE FAIRNESS. THE ONLY THING
THEY COULDN'T DO IS PLANT THE FDA FLAG IN THAT EVIDENCE. AND THAT'S BECAUSE
THE FDA FOR EXAMPLE OF CLINICAL STUDIES HAD NOTHING TO DO WITH THE CLIPPING ALLSTATE
LAW STUDIES THAT WE WERE TALKING ABOUT AT TRIAL WHICH POLICE DON'T FORGET, THEY I WANT
DUES HAD THE CONCEPT IN THEIR DESIGN CONTROL PROCESS WHEN THEY PICKED A ISO
REGULATION STANDARD, NOT REGULATION, A STANDARD THAT SAID YOU CAN DO STUDIES
OR YOU CAN DO LITERATURE SEARCH BUT IF YOU DO THE LITERATURE SEARCH THEIR EXPERT
ADMITTED YOU HAVE TO BE REBUT AND OBJECTIVE YOU HAVE TO LOOK AT ALL COUNTER
LITERATURE AND IF LITERATURE SAYS STUDIES ARE NEEDED YOU HAVE TO TAKE IT SERIOUSLY.
IN THIS CASE WE SHOWED THE JURY THAT THIS STUDIES THEY RELIED ON SAID STUDIES
WERE NEEDED AND SAYING WELL THE FAT SAID DIDN'T NEED A STUD WOULD HAVE BEEN
COMPLETELY 100 PERCENT IRRELEVANT BECAUSE ALL THAT STUDY WOULD HAVE SPOKEN TO
SUBSTANTIAL KIND OF LENS TO SOMETHING ELSE THAT THE JURY WASN'T LEARNING ABOUT
AND THEN WE'RE DOWN INTO THE RABBIT HOLE WAS LET'S TALK ABOUT THE PRESENTED
INDICATES LET'S TALK ABOUT EVERYTHING THAT CAME BEFORE THAT'S WHY AGAIN THE US BY
DISCRETION STANDARD HAS TO BE RESPECTED. AND RESPONDING TO WHAT YOU SAID
CHIEF JUSTICE RABNER ABOUT PUNITIVE DAMAGES IT'S THE SAME EXACT QUESTION. WHEN YOU
SAFFIANS. THEIR STATE OF MIND ONLY MARRIED IN TERMS OF HOW THEY DESIGNED THE
PRODUCT AND WHAT WARNINGS THEY PROVIDED. NEITHER OF THOSE DECISIONS WERE REVIEWED
FOR SAFETY AND EFFECTIVENESS ON A CLIPPING ALLSTATE LAW MEDICAL RISK BENEFIT LEVEL
BY THE FDA BECAUSE THAT'S NOT WHAT THEY DO AND YOU CAN LOOK AT THE DOCUMENTS. IT'S
NOT THERE AND THEIR EXPERT ADMITS THAT SUCH A STUDY PER THE FDA WOULD NOT HAVE
TOUCHED THE ISSUES AT TRIAL. AGAIN, CISSON SAYS THE BASIC QUESTION IS HOW
MUCH INFORMATION DOES 510(K) SLEEPS PROVIDE A JURY ABOUT THE SAFETY OF THE UNDERLYING
PRODUCT AND IS THE VALUE OF THAT INFORMATION SUBSTANTIALLY OUTWEIGHED. THAT'S
THE QUESTION, THAT TRACTOR TRAILERS WEIGHING QUESTION THE TRIAL JUDGE HAS TO
MAKE AND THAT'S WHY ABUSIVE DISCRETION STANDARD HAS TO RESPECT IT EVEN IF ONE
SAYS WELL I THINK I CAN MANAGE THE TRIAL AND I CAN GIVE A LIMITING INSTRUCTION YOU
HAVE TO SAY WELL THE TRIAL JUDGE WHO IS MILLIGRAM AND REMEMBER THE VERSUS WHO
ARE MADE THESE SITUATIONS MCL JUDGES AT ONE POINT I THINK WE HAD OVER $12,000.
THE FEDERAL MDL JUDGE MANAGED 12,000 CASE THESE ARE THE JUDGES THAT ARE ON THE
MOST EXPERT WITH THESE CASES IN THE UNITED STATES. THEIR JUDGMENT HAS TO BE
RESPECTED. EVEN IF YOU SAY WELL I COULD DIFFER WITH THAT AND I COULD DO IT DIFFERENTLY.
THAT'S THE CALL OF THE ABUSE DISCRETION STANDARD POLICY. THESE ARE THE MOST
EXPERT JUDGES IN THE UNITED STATES AND LOOK AT EVERY APPELLATE COURT OTHER THAN
OUR APPELLATE DIVISION HAS SAID WE UNDERSTAND THE RATIONALE, WE SEE WHAT
YOU DID AND WE WERE GOING TO RESPECT THAT AND WE'RE NOT GOING TO TOUCH IT AND
THAT'S WHAT WE ASK YOU TO DO IS TO SAY THE ABUSIVE DISCRETION STANDARDS MATTERS
WE'VE BEEN IN THE WEEDS ALL DAY WHERE WE BELONG TO GO THROUGH THIS AND IT'S
HARROWING BUT THE BOTTOM LINE IS THE TRIAL JUDGE WENT THROUGH ALL THIS. NOBODY,
INCLUDING THE COURT -- THE APPELLATE COURT HAS SAID THE JUDGE DIDN'T CONSIDER
SOMETHING, HIS DECISIONS WERE VERY DETAILED. HE CONSIDERED EVERYTHING, HE WAS VERY
PATIENT, FULL PROFFERS MADE SO AT THAT POINT WE HAVE TO SAY OKAY, WE HAVE TO
RESPECT WHAT YOU DID BECAUSE THERE'S NOTHING HE DIDN'T CONSIDER. CHIEF JUSTICE
RABNER: LET'S GET OUT OF THE WEEDS RIGHT NOW IS THERE ANY OTHER POINT YOU WANT
TO MAKE BEFORE ENDING YOUR REBUTTAL. ADAM M. SLATER: GIVE ME ONE MOMENT.
CHIEF JUSTICE RABNER: NEITHER ONE OF US CAN COUNT TO EIGHT MINUTES, I CAN ASSURE
OF THAT. ADAM M. SLATER: TIME STANDS STILL AND THEN IT MOVES TOO
FAST. A COUPLE OF THE CASES THAT WERE SIGHTED BY THE DEFENSE I THINK IT'S
IMPORTANT FOR ME TO COMMENT ON. CHIEF JUSTICE RABNER: I WOULD ASK YOU TO
DO SO BRIEFLY SOLID SOLID FELDMAN AND KEN DISMISSAL WITH HIS MML PRODUCT CASE NOT
510(K). WHAMMED THERE WAS EXECUTED EVIDENCE WAS EVIDENCE THAT WENT TO THE
HEART OF THE CLAIM. IN THE KEN DISMISSAL CASE THE SUBSTANTIVE EVIDENCE WAS
ADVERSE EVENT REPORTS VERSUS TOTAL SALES THAT WAS DIRECTLY ANSWERING THE PLAINTIFF'S
EXPERT CAUSATION OPINIONS, THIS IS NOT SUBSTANTIVE EVIDENCE. NOBODY HAS MADE AN
ARGUMENT THAT 510(K) CLEARANCE BY BEING HE KEPT OUT DERIVED BARD OF SHITTING
ANY SUBSTANTIVE EVIDENCE AT TRIAL. AND I WILL SAY ONE OTHER THING. THE EXAMPLE
NAME CASE I DON'T KNOW IF I'M PRONOUNCE IT RIGHT FROM THE 11 CIRCUIT DIRECTLY
QUESTION LOOP SAFETY TESTING WHICH WAS THE THEME OF THE PLAINTIFF SHOULD HAVE OPENED
THE DOOR OR ALLOWED IN THE CLINICAL STUDIES AND THEY SAID THAT BEGS THE QUESTION.
IT DOESN'T -- YOU CAN'T CHANGE 510(K) INTO SOMETHING ELSE BECAUSE THE EVIDENCE
GETS INTO THE LACK OF TESTING. THEY LITERALLY LOOKED AT THAT EXACT ISSUE AND
THE LAST THING I'M GOING TO SAY IS THIS. THERE IS NO WAY BECAUSE I HAVE TO
SAY THIS AS MY LAST THING, THERE IS NO WAY FOR A COURT FROM OUR PERSPECTIVE ON THIS
RECORD WITH THE PELVIC MESH DEVICES WITH ALL OF THE THINGS THAT ARE TIED UP
IN THAT, ALL OF THE FACTS, ALL OF THE HISTORY TO HAVE ADEQUATELY PROTECTED
THIS JURY FROM OUR PERSPECTIVE FROM CONFUSION AND PREJUDICE. THAT'S WHAT THE JUDGE
FOUND. AND WE HAVE MULTIPLE FEDERAL COURTS OF APPEALS WHO RESPECTED THE DECISIONS
OF JUDGE GOODWIN AND I BELIEVE IN ONE OF THE CASES ANOTHER JUDGE IN WEST VIRGINIA
SAT BY DESIGNATION BECAUSE WHILE JUDGE GOODWIN WAS TRYING A CASE IN FLORIDA
THE OTHER JUDGE TRIED A CASE IN WEST VIRGINIA, THAT'S THE FACT, THERE'S NO
WAY TO ADEQUATELY PROTECT. BUT EVEN IF YOU DISAGREE, EVEN IF YOU DISAGREE WITH THE
TRIAL JUDGE WHO THOUGHT ABOUT WE ASK YOU TO SAY OKAY HE'S THE TRIAL JUDGE.
THESE ARE THE MCL JUDGES, WE HAVE TO DEFER TO THERE DISCRETION THAT YOU SO
MUCH. THE COURT: MR. KOTT. DAVID R. KOTT: MR. SLATER JUST AGREED
WITH ME THAT WE WERE REQUIRED TO USE THE 510(K) PROCESS. SO ON SECTION FIVE WHAT
HE'S SAYING IS THAT SECTION FIVE DOES NOT PROTECT US FROM PUNITIVE DAMAGES
BECAUSE WE WERE REQUIRED TO USE THE 510(K) PROCESS. EVEN THOUGH AS REFLECTED
IN SOME OF THE BRIEFS ABOUT 90 PERCENT OF THE PRODUCTS GO THROUGH 510(K). AND
IT IS HARD FOR ME TO BELIEVE THAT THE LEGISLATURE WOULD HAVE SAID WE'RE GOING TO
GIVE PROBATION FOR DEVICES PROTECTION FOR DEVICES FROM PUNITIVE DAMAGES BUT
WE'RE NOT GOING TO GIVE IT WHEN THE CONNING OF THE UNITED STATES AND THE FDA
REQUIRES THE MANUFACTURER GO THROUGH A PATHWAY OF CLASS TWO CLEARANCE. THE
OTHER POINT I WANT TO MAKE AND I'M GOING TO GO A LITTLE SLOWER ON THIS BECAUSE IT'S
A LITTLE COMPLICATED. MR. SLATER'S ARGUING WORDS OF ART. THAT'S WHAT HE'S
ARGUING AS I SAID IT'S THE LEGAL ISSUE. IF THE THIS COURT SAID YES, IT'S
WORD OF ART, DRUGS WILL NEVER EVER GET THE BENEFIT OF SECTION FIVE. AND THE
REASON I SAY THAT IS DRUGS DO NOT GO THROUGH PRE MARKET APPROVAL OR LICENSE
OR GENERALLY RECOGNIZED AS SAFE. DRUGS GO THROUGH AN ENTIRELY DIFFERENT PROCESS
WHICH IS CALLED THE NEW DRUG APPLICATION. SO IF THE ACCEPT THE ARGUMENT
THAT PLAINTIFF MAKES ON WORDS OF ART YOU'VE JUST REACHED AN ABSURD READING
OF SECTION FIVE BECAUSE IT WOULD RESULT IN DRUGS NOT HAVING THE BENEFIT OF SECTION
FIVE. FINALLY, ON WHETHER THE FDA REQUIRED CLINICAL TESTING, MR. SLATER
SAID THAT WAS RELATE TO DO SUBSTANTIAL KIND OF LENS, I'D CALL THE COURT'S ATTENTION
TO THE APPELLATE DIVISION APPENDIX, PAGE 2563, 2717, THAT IS WHERE THE FDA
SAID NO CLINICAL TESTING IS REQUIRED AND AS I READ THE DOCUMENT, IT IS UNTETHERED
TO SUBSTANTIAL KIND OF LENS. MR. CHIEF JUSTICE RABNER, THAT COMPLETES MY
REBUTTAL BUT I'M GLAD TO ANSWER ANY QUESTIONS THAT THE COURT HAS. CHIEF JUSTICE
RABNER: THANK YOU, MR. KOTT AND I WANT TO THANK EVERYONE IT'S A PRIVILEGE TO
HEAR VERY FINE ARGUMENTS. I APOLOGIZE WE DIDN'T HAVE MORE TIME FOR ALL OF THE AMEX
MR. COHEN SORRY ABOUT THAT. THE COURT IS GOING TO TAKE THE MATTER UNDER
ADVICEMENT.