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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

Failed Metal Taper/Stem Systems Hip Failure Epidemic Metal-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

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

First Successful Hip Implants Invented By Sir John Charnley Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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) Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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” Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

$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. Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

Glynn Trial: Loss by plaintiff April 2013 Illinois First 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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

Preserving HIP IMPLANT Revision Evidence Hospital to retain hardware? Patient? Litigation depository? Photographs taken by surgeon Pathology specimens Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

WHAT MONEY DAMAGES ARE 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…) Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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

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

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

DePuy (JOHNSON & JOHNSON): ASR and Pinnacle MODELS Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

Depuy asr xl “Monoblock” design: all matching cobalt/chromium cup/stem/ball Large size options Poor rim design, shallow cup Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

DePuy Pinnacle M-o-M Hips Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

Pinnacle-Specific Components Modular hip replacement Outer shell Inner liner Femoral head Femoral stem Screws Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

Types of Pinnacle Liners Ultamet (metal) AltrX (polyethylene) Marathon (polyethylene) Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

Wright Metal-on-Metal Hip Implants Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

Wright, MDL No. 2329 MDL: Atlanta, Georgia Judge William S. Duffey, Jr. Metal-on-metal cases related to Conserve product line only Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

Stryker Rejuvenate and ABG II Hips Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

Stryker rejuvenate and abg II LITIGATION Consolidated litigation: Judge Martinotti, Bergen Co., NJ Exploring possible mediation program Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

BIOMET MAGNUM 38 & M2a LITIGATION Consolidated litigation: Judge Miller, Northern District of Indiana, MDL 2391 No trial dates set – maybe 2015 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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