113 East 37 th Street New York, NY 10016 (212) 684-1880 or (800) 349-0004 1.

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


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


REASONS FOR HIP IMPLANTS

Arthritis

Trauma

Avascular necrosis

Damaged or diseased bone in hip joint

Help the joint work better

Improve walking

Relieve pain


FIRST SUCCESSFUL HIP IMPLANTS INVENTED BY SIR JOHN CHARNLEY


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


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)


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”


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


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


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


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


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


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


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


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


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


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


$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.


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


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


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


PRESERVING HIP IMPLANT REVISION EVIDENCE

Hospital to retain hardware? Patient? Litigation depository?

Photographs taken by surgeon

Pathology specimens


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


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


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…)


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


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!)


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


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


DEPUY (JOHNSON & JOHNSON):ASR AND PINNACLE MODELS


DEPUY ASR XL “Monoblock” design: all matching

cobalt/chromium cup/stem/ball

Large size options

Poor rim design, shallow cup


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


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


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


DEPUY PINNACLE M-O-M HIPS


PINNACLE-SPECIFIC COMPONENTS

Modular hip replacement– Outer shell– Inner liner– Femoral head– Femoral stem– Screws


TYPES OF PINNACLE LINERS

Ultamet (metal)

AltrX (polyethylene)

Marathon (polyethylene)


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


WRIGHT METAL-ON-METAL HIP IMPLANTS


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


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


WRIGHT, MDL NO. 2329 MDL: Atlanta, Georgia

Judge William S. Duffey, Jr.

Metal-on-metal cases related to Conserve product line only


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


STRYKER REJUVENATE AND ABG II HIPS


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


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


STRYKER REJUVENATE AND ABG IILITIGATION

Consolidated litigation: Judge Martinotti, Bergen Co., NJ

Exploring possible mediation program


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

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