Presentation is loading. Please wait.

Presentation is loading. Please wait.

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

Similar presentations


Presentation on theme: "113 East 37 th Street New York, NY 10016 (212) 684-1880 or (800) 349-0004 www.Rheingoldlaw.com 1."— Presentation transcript:

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

2 The history, development, design, and current health concerns of metal-on-metal hip implants & Courts, trials, verdicts and settlements 2 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

3 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 3 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

4  Arthritis  Trauma  Avascular necrosis  Damaged or diseased bone in hip joint  Help the joint work better  Improve walking  Relieve pain 4 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

5 5

6  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 6 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

7  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) 7 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

8  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” 8 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

9  Medical device companies claimed they would last longer than polyethylene and ceramic  Larger size would reduce dislocations  Younger, more active populations 9 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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

11  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 11 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

12  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 12 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

13  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 13 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

14  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 14 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

15  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 15 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

16  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 16 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

17  Sulzer hip implant – 2002 – Recalled in 2000 for machinery oil on hardware  Stryker Trilogy (Pre-Market Approval) – 2008 – Ceramic on ceramic squeaking 17 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

18  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 18 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

19  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. 19 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

20  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 20 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

21  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 21 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

22  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 22 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

23  Hospital to retain hardware? Patient? Litigation depository?  Photographs taken by surgeon  Pathology specimens 23 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

24  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 24 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

25  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 25 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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

27  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 27 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

28  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! ) 28 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

29  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 29 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

30  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 30 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

31 31 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

32  “ Monoblock” design: all matching cobalt/chromium cup/stem/ball  Large size options  Poor rim design, shallow cup 32 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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

34  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 34 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

35  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 35 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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

37  Modular hip replacement – Outer shell – Inner liner – Femoral head – Femoral stem – Screws 37 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

38  Ultamet (metal)  AltrX (polyethylene)  Marathon (polyethylene) 38 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

39  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 39 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

40 40 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

41  Conserve Total Hip System  Conserve Plus Total Resurfacing Hip System  Lineage Acetabular Cup System  Dynasty Acetabular Cup System 41 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

42  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 42 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

43  MDL: Atlanta, Georgia  Judge William S. Duffey, Jr.  Metal-on-metal cases related to Conserve product line only 43 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

44  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 44 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

45 45 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

46  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 46 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

47  Canadian recall – May 28, 2012 – Rejuvenate only, not ABG II  American recall – July 4, 2012 – No plan to pay for revision surgeries 47 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

48  Consolidated litigation: Judge Martinotti, Bergen Co., NJ  Exploring possible mediation program 48 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

49  Consolidated litigation: Judge Miller, Northern District of Indiana, MDL 2391  No trial dates set – maybe 2015 49 Rheingold, Valet, Rheingold, McCartney & Giuffra LLP

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


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

Similar presentations


Ads by Google