DePuy’s ASR and other metal-on-metal hip implants were approved via the 510(k) route, which exempts devices from clinical testing.
New York, NY (PRWEB) July 31, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, is pleased with San Francisco Superior Court Judge Richard A. Kramer’s decision to issue a July 16 Order permitting Plaintiffs in DePuy ASR litigation to amend their lawsuits to include DePuy Pinnacle hip implant claims. Seven Plaintiffs, altogether, are seeking to amend their lawsuits as now permitted (Case Nos. CGC-11-510094, CGC-12-518673, CGC-11-516802, CGC-10-505068, CGC-11-508971, CGC-12-523317 and CGC-11-507817).
According to information from the U.S. Food and Drug Administration (FDA), those with metal hip implants may experience adverse events after surgery, including:
- Hip dislocation, when the ball of the thighbone (femur) slips out of its socket in the hip bone (pelvis)
- Bone fracture
- Joint infection
- Local nerve damage with numbness/weakness
- Device loosening or breakage
- Difference in leg lengths
- Bone loss (osteolysis)
The FDA also noted that patients should be aware of potential symptoms that may occur after three or more months after surgery, including:
- Pain in the groin, hip or leg
- Swelling at or near the hip joint
- A limp or change in walking ability
- Noise (popping, grinding, clicking or squeaking) from the hip joint
DePuy’s ASR and other metal-on-metal hip implants were approved via the 510(k) route, which exempts devices from clinical testing as long as the manufacturers show that their product is similar to a previous device already on the market. The FDA reported on Jan. 18, 2013, that it was attempting to change the 510(k) approval process; the agency has proposed that all-metal hip replacements go through premarket approval, which would require device makers to prove that their products are safe and
A March 8, 2013, Bloomberg article noted that Johnson & Johnson, DePuy’s parent company, recalled 93,000 ASR hips in 2010, citing a failure rate of 12 percent in five years. In Australia, failure rates have exceeded 40 percent in seven years, Bloomberg reported.
Parker Waichman LLP continues to offer free legal consultations to victims of DePuy ASR and other metal-on-metal hip implant injuries. If you or a loved one experienced premature failure of your implant or other health problems associated with a recalled DePuy ASR Hip Implant or other metal-on-metal hip implant, please contact their office by visiting the firm's DePuy ASR hip implant injury page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney