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

113 East 37 th Street New York, NY 10016 (212) 684-1880 or (800) 349-0004 www.Rheingoldlaw.com. Metal-on-metal hip IMPLANTs. The history, development, design, and current health concerns of metal-on-metal hip implants & Courts, trials, verdicts and settlements .

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

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

  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 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

  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 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

  7. History of metal-on-metal implants (Cont’d) • The initial prosthesis consisted of a teflonacetabular 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

  8. 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

  9. 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

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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. $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

  20. Glynn Trial: Loss by plaintiffApril 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

  21. Federal Multidistrict TrialSeptember 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

  22. 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

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

  24. 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

  25. 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

  26. 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…) Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

  27. 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

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

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

  32. 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

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

  35. 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

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

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

  39. 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

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

  41. 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

  42. 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

  43. 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

  44. 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

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

  46. 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

  47. Recalls for strykerrejuvanate 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

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

  49. 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

  50. 113 East 37th Street New York, NY 10016 (212) 684-1880 www.Rheingoldlaw.com Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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