1. 113 East 37th Street New York, NY 10016

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. 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

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 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

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 (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 “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 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

21. 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

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 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

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
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 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

48. Stryker rejuvenate and abg II LITIGATION
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
113 East 37th Street New York, NY (212)
Rheingold, Valet, Rheingold, McCartney & Giuffra LLP