113 east 37 th street new york, ny 10016 (212) 684-1880 or (800) 349-0004 1
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113 East 37th Street New York, NY 10016 (212) 684-1880 or (800) 349-0004
www.Rheingoldlaw.com
Rheingold, Valet, Rheingold, McCartney & Giuffra LLP 2
METAL-ON-METAL HIP IMPLANTS
The history, development, design, and current health concerns of
metal-on-metal hip implants&
Courts, trials, verdicts and settlements
Rheingold, Valet, Rheingold, McCartney & Giuffra LLP 3
HIP FAILURE EPIDEMICMetal-on-Metal
DePuy ASR DePuy Pinnacle Wright Dynasty Wright Conserve Biomet Magnum 38 & M2a Zimmer Durom Cup Smith & Nephew R3
Failed Metal Taper/Stem
Systems
Wright Profemur Stryker
Rejuvenate Stryker ABG II Stryker Accolade
Rheingold, Valet, Rheingold, McCartney & Giuffra LLP 4
REASONS FOR HIP IMPLANTS
Arthritis
Trauma
Avascular necrosis
Damaged or diseased bone in hip joint
Help the joint work better
Improve walking
Relieve pain
Rheingold, Valet, Rheingold, McCartney & Giuffra LLP 5
FIRST SUCCESSFUL HIP IMPLANTS INVENTED BY SIR JOHN CHARNLEY
Rheingold, Valet, Rheingold, McCartney & Giuffra LLP 6
HISTORY OF METAL-ON-METAL IMPLANTS
Starting in 1880, doctors attempted to create hip implants but were unsuccessful
1950’s: McKee from Britain, and later Herbert from France, first generation metal on metal bearing used; mostly abandoned due to excessive wear and metal particles release causing metallosis
Dr. John Charnley, a renowned British orthopedic surgeon, created the first successful series of implantations of the total hip prosthesis in 1962
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HISTORY OF METAL-ON-METAL IMPLANTS (CONT’D)
The initial prosthesis consisted of a teflon acetabular cup, later replaced by high-density polyethylene and a stainless steel monoblock femoral component
The Charnley prosthesis was the most successful and became a “gold standard” for hip replacement (still used in modified versions)
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HISTORY OF METAL-ON-METAL IMPLANTS (CONT’D) Total Hip Replacements “THR”
First generation: 1970’s high failure rate
Second generation: 1980’s to present- 1% per year failure
Stainless steel, nickel, cobalt/chromium, titanium
2006: Resurfacing Implant (does not have femoral ball/neck)
FDA approval: Premarket Approval (PMA) or 510k “substantial equivalence”
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WHY USE METAL-ON-METAL IMPLANTS?
Medical device companies claimed they would last longer than polyethylene and ceramic
Larger size would reduce dislocations
Younger, more active populations
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SIGNS OF FAILING IMPLANT
Pain in the buttock, groin, and/or thigh Elevated levels of cobalt or chromium in
the blood Soft tissue studies (Sonogram or MRI)
showing fluid, pseudotumor, or infection
Squeaking Dislocation of the hip X-Rays showing loose hardware
Rheingold, Valet, Rheingold, McCartney & Giuffra LLP 11
BLOOD TESTS FOR COBALT AND CHROMIUM IONS
Pre 2012 used: 0 to 5 ug/L= “normal” 5 to 10 ug/L= concern 10 to 15 ug/L= consider revision + post-revision
tests Some patients in the 100+ range!
Post 2012: doctors concerned about even lower levels when associated with pain, abnormal x-rays, or abnormal scans/sonograms
Urine tests also available
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HIGH LEVELS OF COBALT/CHROMIUM IONS
Tissue damage Infection Cardiomyopathy Neurological symptoms Hearing, eyesight Chromium known to be genotoxic since
1890 (not a typo!) Potential for cancer due to cellular DNA
mutations No device companies monitored this
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FDA ACTION ON MAY 6, 2011
FDA issues 145 orders for post-market surveillance studies to 21 manufacturers of metal-on-metal hip systems
Manufacturers were required to submit a study plan to the FDA that addressed specific safety issues related to these devices
Must include failure rates of implants
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FDA HOLDS PANEL ON M-O-M HIPS JUNE 27, 2012
FDA asks panel to suggest how to study this problem, leading industry experts discuss safety and effectiveness of M-o-M hips, issues long report
Patients express concern
Panel’s chair tells media he would not use these in his practice going anymore because he sees too many risks and no benefit
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FDA SAFETY COMMUNICATION JANUARY 17, 2013
New “Proposed Order”
Change 510k to premarket approval
Comments submitted through April 18, 2013
Final order to be issued 90 days after order, becomes a PMA device
and will most likely permanently end sales
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FDA RECOMMENDATIONS FOR M-O-M PATIENTS
Do testing to determine if there is: – adverse local tissue reaction “ALTR”– adverse reaction to metal debris “ARMD”
X-ray, scans, soft tissue sonograms Blood tests for cobalt and chromium Special attention: bilateral, females, bad
alignment, overweight, high level physical activity
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PRIOR HIP IMPLANT LITIGATION
Sulzer hip implant– 2002– Recalled in 2000 for machinery oil on
hardware
Stryker Trilogy (Pre-Market Approval)– 2008– Ceramic on ceramic squeaking
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ZIMMER DUROM CUP LITIGATION
MDL in Newark, NJ: Judge Arleo – most cases already settled through mediation
July 22, 2008: recall for loosening acetabular cups (new implanting instructions)
Cup rim design prevents bony in-growth
Now seeing metallosis cases
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$8.3 MILLION TRIAL VERDICT AGAINST DEPUY
Leon Kransky,65 y.o., trial in Los Angeles. DePuy ASR implanted in 2007, revised 2012. “Preference” trial due to cancer
March 2013 verdict for revision patient
$330,000 for medical bills and expenses
$8 million for past and future pain and suffering . No punitive damages.
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GLYNN TRIAL: LOSS BY PLAINTIFFAPRIL 2013
IllinoisFirst Illinois state trial (more to come)
Cook County, Judge Dooling
54 year old nurse implanted with ASR in 2008, revision in 2011
DePuy used “individual biology” defense:many pre-existing problems implanting surgeon is one who decides
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FEDERAL MULTIDISTRICT TRIAL
SEPTEMBER 2013, JUDGE KATZ
Faye Dorney-Magditz, in her 50’s
2009 insertion - “late insertion”- Punitive damages?
Revision due to pain and high metal levels
Doing well after revision
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REVISION SURGERY Decision made with surgeon
Replace one or more of the following: stem, ball, neck
Remove scar tissue, excess fluid, dead tissue, metal shreds
If infection, place antibiotic spacer for 6 weeks
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PRESERVING HIP IMPLANT REVISION EVIDENCE
Hospital to retain hardware? Patient? Litigation depository?
Photographs taken by surgeon
Pathology specimens
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REVISION SURGERY OUTCOMES:THE GOOD, THE BAD, AND THE UGLY
Approximately 10% of revision surgeries have some type of complication requiring further surgery within 1 year
Infection Dislocations (poor muscle strength) Only minor relief of pain due to very
compromised bone or soft tissue Significant movement limitations Stress on back, hips, knees, feet Hip implant longevity decreases
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DO I HAVE A CLAIM? Have you had an implant revision? Reason for revision: failure due to defect? Can you identify the manufacturer of the
implant? Pain & suffering- past/future Permanent disability Loss of income Time limits to file suit – NY 3 years Best court for you Not suing doctors
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WHAT MONEY DAMAGESARE PART OF A CLAIM?
Past pain and suffering Future pain and suffering Unpaid past/future medical bills Past/future lost earnings Lost earning capacity “Out of pocket” expenses Lost retirement benefits Punitive damages (…threat of…)
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BROADSPIRE “CLAIM” SERVICES
Private company hired by DePuy and Stryker
Allegedly provides reimbursement for medical bills, lost income, associated “out of pocket” expenses
Obtains complete access to your medical records
Close relationship with some orthopedic surgeons
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HOW WILL DEVICE COMPANY ATTACK MY CLAIM? FOCUS GROUPS Our implants may have had some
problems, but not in your case
Surgeon did not implant it correctly
You weren’t a proper candidate
Your “individual biology” does not make you a good implant candidate (but never told doctors that!)
Rheingold, Valet, Rheingold, McCartney & Giuffra LLP 29
HOW WILL DEVICE MANUFACTURER ATTACK MY CLAIM? (CONT’D)
You did not have any complaints until you heard of the recall or saw an attorney ad
There is no microscopic evidence of abnormal wear on the removed hardware
You don’t have the removed hardware and can’t support your failure allegations
The revision surgeon did not mention any metallosis conditions in the surgical report
Rheingold, Valet, Rheingold, McCartney & Giuffra LLP 30
HOW WILL DEVICE MANUFACTURER ATTACK MY
CLAIM? (CONT’D) Your implant was put in before we knew
about the problems
You waited too long to file suit (statue of limitations)
Your implant failure was caused by the pre-existing medical conditions you have
Your surgeon won’t say there was a problem
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DEPUY (JOHNSON & JOHNSON):ASR AND PINNACLE MODELS
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DEPUY ASR XL “Monoblock” design: all matching
cobalt/chromium cup/stem/ball
Large size options
Poor rim design, shallow cup
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DEPUY ASR RECALLS 2007 “smoking gun” PowerPoint
2008-2009 DePuy internally decides to phase out ASR line while still promoting sales and defending failures – blames doctors
2009 DePuy voluntarily recalls ASR in Australia
August 2010 worldwide voluntary recall
Rheingold, Valet, Rheingold, McCartney & Giuffra LLP 34
ASR’S FAILURE RATE Scientific literature:
– At recall (August 2010): Data showed eight to twelve percent increased risk of revisions within five years
– July 2011: Data shows 25% increased risk of failure in the ASR resurfacing hip and 49% increased risk of failure in the ASR THR within six years
– Australian Implant Registry 2012 data expects 44% revision rate at 7 years
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ASR LITIGATION UPDATE Federal court multidistrict litigation (MDL)
– Judge David R. Katz, N.D. Ohio– Trials set in Fall 2013
California and Illinois state court consolidated litigation
New Jersey state court consolidated litigation: Judge Martinotti, Bergen Co., NJ—Trials set in September and November
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DEPUY PINNACLE M-O-M HIPS
Rheingold, Valet, Rheingold, McCartney & Giuffra LLP 37
PINNACLE-SPECIFIC COMPONENTS
Modular hip replacement– Outer shell– Inner liner– Femoral head– Femoral stem– Screws
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TYPES OF PINNACLE LINERS
Ultamet (metal)
AltrX (polyethylene)
Marathon (polyethylene)
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STATUS OF PINNACLE LITIGATION
MDL: Northern District of Texas– Over 2,500 cases filed in
MDL :September 1, 2014 first trial
California consolidated litigation
In May 2013 DePuy announces that the M-o-M Pinnacle line will be discontinued
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WRIGHT METAL-ON-METAL HIP IMPLANTS
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FOUR TYPES OF WRIGHT METAL-ON-METAL HIP IMPLANTS
Conserve Total Hip System Conserve Plus Total Resurfacing Hip
System Lineage Acetabular Cup System Dynasty Acetabular Cup System
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WRIGHT PROFEMUR MODULAR NECK FRACTURES Catastrophic failure of the implant Modular neck fractures involve defects
and injuries that are distinct Stem is often paired with a Conserve or
Dynasty acetabular cup Cases involving modular neck fractures
are excluded from both federal and California coordinated proceedings
Must litigate with individual suit
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WRIGHT, MDL NO. 2329 MDL: Atlanta, Georgia
Judge William S. Duffey, Jr.
Metal-on-metal cases related to Conserve product line only
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WRIGHT, JCCP NO. 4710(CALIFORNIA)
In re Wright Hip Sys. Cases, JCCP 4710, Super. Ct. Cal., L.A.
Judge Jane L. Johnson
All Wright metal-on-metal hip implants including those from the Conserve, Dynasty, and Lineage product lines
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STRYKER REJUVENATE AND ABG II HIPS
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PRODUCT OVERVIEW
Manufactured by Howmedica in Mawah, NJ
Modular design promoted as non metal-on-
metal after ASR recall
Titanium stem
Cobalt/chromium neck
Polyethylene ball
Metal cup
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RECALLS FOR STRYKER REJUVANATE AND ABG II
Canadian recall– May 28, 2012– Rejuvenate only, not ABG II
American recall– July 4, 2012– No plan to pay for revision surgeries
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STRYKER REJUVENATE AND ABG IILITIGATION
Consolidated litigation: Judge Martinotti, Bergen Co., NJ
Exploring possible mediation program
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BIOMET MAGNUM 38 & M2A LITIGATION
Consolidated litigation: Judge Miller, Northern District of Indiana, MDL 2391
No trial dates set – maybe 2015
113 East 37th Street New York, NY 10016 (212) 684-1880 www.Rheingoldlaw.com