PROPOSED FEDERAL MEDICAL MALPRACTICE TORT REFORM

LEGISLATION AKA H.R. 5

Preempts any state law unless the state law imposes greater protection for health care providers.

Damages

• $250,000 cap in non-economic damages.

Statute of Limitations

• 3 year statute of limitation for health care lawsuits or 1 year after the time the claimant discovers, or should have discovered the injury.

Punitive Damages

• Must be proven by clear and convincing evidence.
• Capped at $250,000 or 2 times the amount of the economic damages award, whichever is greater.
• No punitive award for products that comply with FDA standards.

Payments on Future Damages

• Future damages equaling or exceeding $50,000 shall be paid out in periodic payments if requested by the defendant.

Attorney Fees

• Attorneys are entitled to:
• 40% of the first $50,000 recovered.
• 33 1/3 % of the next $50,000 recovered.
• 25% of the next $50,000 recovered.

PRODUCT LIABILITY INVESTIGATIONS

FOSAMAX

Thousands of Americans have been taking the prescription drug FOSAMAX since 1995 for treatment and prevention of osteopenia and osteoporosis. On October 13, 2010 , the FDA issued a warning to physicians caring for patients taking FOSAMAX noting that all FOSAMAX and other bisphosphonates have been associated with atypical fractures to the femur. ¹Women are especially at high risk of suffering these fractures. ²Patients typically require immediate surgery including placement of orthopedic hardware such as plates and screws and are subject to a very slow recovery process.

CHANTIX

Chantix is a popular smoking cessation drug that has been linked to dangerous neuropsychiatric side effects, including suicidal behavior, agitation, depression, and the onset of other psychiatric illness like psychosis, mania, bipolar disorder, schizophrenia, and hallucinations. ³Between the drug’s 2006 approval and July 2009, the FDA reported the Chantix accounted for 4,762 reports of serious psychiatric events including 98 reports of completed suicide and 188 reports of attempted suicide. Thus, in July 2009, the FDA required the Chantix manufacturer Pfizer to place a “black box warning” – the strictest warning available – regarding these problems on the label.

DEPUY ASR HIP IMPLANT RECALL – UP TO 49% FAILURE RATE REPORTED

In August 2010, DePuy Orthopaedics and Johnson & Johnson recalled the ASR XL Acetabular Hip System and the ASR Hip Resurfacing System. Approximately 93,000 of these devices have been implanted globally. Many studies report that these implants are failing early and at an alarming rate, requiring patients to undergo revision surgeries. ⁵ In March 2011, the British Orthopaedic Association and the British Hip Society issued a statement that new data indicates the rate of revisions range from 21%at 4 years and 49% at 6 years after the original implant.

DEPUY PINNACLE HIP IMPLANTS

DePuy Orthopaedics, Inc. is also facing public scrutiny regarding the premature loosening and failure of the Pinnacle hip prostheses. Within the past year alone, the FDA has received hundreds of adverse reports regarding failures or other complications related to the Pinnacle device. ⁷ On May 16th, the judicial panel on MultiDistrict litigation will consider a petition to create an MDL devoted to litigation concerning the DePuy Pinnacle.

1. U.S. Food and Drug Administration, Possible Increased Risk of Thigh Bone Fracture with Bisphosphonates (October 14, 2010), available at http://www.fda.gov/NewsEvents/Newsroom/pressannouncements/ucm229171.html.
2. Laura Y. Park-Wyllie, PharmaD, MSc, et Al,. Bisphosphonate Use and the Risk of subtrochanteric or Femoral Shaft fractures in Older Women, JAMA Vol. 305, No 6 (Feb, 23, 2011).
3. R. Freedman, Exacerbation of Schizophrenia by Varenicline. Am J Psychiatry. 2007; 164(8); 1269 I Kohen et al. Varenicline-Induced Manic Episode in a Patient with Bipolar Disorder, Am J psychiatry, 2007; 164(8); 1269-70; AE Morstad, et al. Hypomania with Agitation Associated with Varenicline Use in Bipolar II Disorder. The annals of Pharmacotherapy, 2008; 42:288-ISMP, Strong Safety Signal Seen for New Varenicline Risks, May 21, 2008.
4. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170100,htm.
5. See e.g., DePuy Orthopaedic Surgeons Annual Meeting Feb, 2011 Poster No. P076, available at www.aaos.org (finding ASR total hip replacement has 4 times the risk of revision compared to other conventional total hip replacement).
6. J&J Hip Failure Rate as High as 49 Percent, U.K. Doctors Say, Bloomberg News, March 9, 2011 available http://www.bloomberg.com/news/2011-03-09/j-j-hip-replacement-failure-rate-may-be-49-u-korthopedists-group-says.htm.
7. see FDA MUADE Database, available at http//www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextResults.cfm?dis=101&q=pinnacle&pf=Data_Date_Year:2011,Data_Date_Year:2010&pn=10&sc=.
8. See United States Judicial Panel on Multidistrict Litigation, Notice of Hearing Session, available at http//www.jpml.uscourts.gov/Hearing_Order5-16-.pdf.