Thursday, June 16, 2011

Younger Patients Suffer the Most in DePuy Hip Recall

DePuy Orthopedics announced on August, 2010 that it was voluntarily recalling the ASR hip replacement system after receiving reports that a higher-than-normal number of patients required revision surgeries to correct or remove defective implants. The company said it was pulling the Acetabular and ASR Hip Resurfacing systems from the market "due to the number of patients who required a second hip replacement procedure." Lawsuits over the ASR implant have piled up across the country, accusing DePuy of manufacturing a defective product, failing to warn patients and doctors of problems with the implant and negligence in designing, manufacturing and selling the product. DePuy, which introduced the ASR in the U.S. in 2005 after winning clearance from the Food & Drug Administration, allegedly knew of design problems with the cup but failed to adequately warn physicians, according to the lawsuits, which have been scheduled to go ahead as an MDL. Patients are experiencing various DePuy hip complications that require an additional surgery.
On Thursday, the company officially issued a DePuy hip recall, acknowleding that data shows the ASR Hip Resurfacing System has a 12% failure rate and the ASR XL Acetabular System has a 13% failure rate. The risk of DePuy hip problems was especially high among those implanted in women and those with heads below 50 mm. The DePuy ASR hip was especially popular among younger patients because it was marketed as being more stable and less susceptible to dislocation after surgery. However, problems with the metal-on-metal implant began rolling in shortly after the devices were introduced.
All of the DePuy lawsuits involve similar allegations that the DePuy Pinnacle Acetabular Cup System was defectively designed or manufactured, and that inadequate warnings were provided about the risk of complications or problems following hip replacement. The MDL Panel determined that the actions all involve common questions of fact and that centralization of the cases will serve the convenience of the parties and witnesses, as well as promote the just and efficient conduct of the litigation. Establishing a DePuy Pinnacle Hip MDL will also help eliminate duplicative discovery, prevent inconsistent pretrial rulings on discovery and other issues, and conserve the resources of the parties, the lawyers and the court.

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