Documents that have come to light during the first DePuy ASR trial demonstrate that the company had marketed the device even as it received complaints from doctors over the Articular Surface Replacement (ASR), the New York Times reports.
(PRWEB) January 28, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, reports that Johnson & Johnson knew of design problems associated with the DePuy ASR metal-on-metal hip implant long before the device was recalled but made no effort to inform doctors or the public. Documents that have come to light during the first DePuy ASR trial demonstrate that the company had marketed the device even as it received complaints from doctors over the Articular Surface Replacement (ASR), the New York Times reports. Plaintiff’s attorneys also said that Johnson & Johnson hid data showing that the metal hip implant failed an internal test.
In mid-2010, J&J recalled 93,000 ASR hip implants worldwide after the replacements failed early in a large proportion of patients. The recall affected two ASR models, a standard total hip replacement and a newer version known as a resurfacing implant, which Johnson & Johnson began selling outside of the United States in 2003. Records show that by 2005, doctors were reporting high failure rates to DePuy and company consultants soon stopped using the implant. Internal DePuy records show that the defect had to do with the design of the acetabular cup used in both versions of the implant; the cup, which acts as the hip socket, had an inside grove that increased the risk of friction between the surfaces of the implant, causing it to shed metal particles.
In 2007, the ASR hip implant failed an internal test to see if the device’s rate of wear was comparable to that of other hip replacements. The report stated that “The current results for A.S.R. do not meet the set acceptance criteria for this test,” according to the New York Times. Despite knowing this information, DePuy continued to market the device as doctors implanted it in tens of thousands of patients. The company also discussed plans to fix the defect, but never followed through.
In 2009, the U.S. Food and Drug Administration (FDA) rejected the resurfacing version of the ASR hip implant due to concerns over the “high concentrations of metal ions” in the patients’ blood. That same year, DePuy announced plans to “phase out” the ASR, claiming that it was doing so because of slowing sales and not safety issues.
The lawsuit going to trial is one of approximately 10,000 alleging that the DePuy ASR hip implant caused injuries, such as metallosis, tissue and bone damage and an early revision rate. The case going to trial is In re: Loren Kransky and Sheryl Kransky v. DePuy, Inc., et al., BC456086, Los Angeles Superior Court. Most of the lawsuits, however, are pending in the multidistrict litigation in the U.S. District for the Northern District of Ohio as part of the In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation (MDL 2197. A status conference was held for the federal multidistrict litigation on January 10th, 2013 addressing the status of the multidistrict litigation docket. The Court stated that the next status conference will be held on February 13th; the first two trials are scheduled for May 6th and July 8th 2013.
The FDA has recently issued new guidelines for patients implanted with metal-on-metal hip implants such as the DePuy ASR, warning that such devices can cause soft tissue reactions by releasing metal ions into the blood. The agency advised metal ion testing, physicals examinations and diagnostic imaging as needed. The FDA is also looking to impose stricter regulations for the implants requiring manufacturers to show that they are safe and effective before selling them.
Parker Waichman LLP continues to offer free legal consultations to victims of 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 metal-on-metal hip implant, please contact their office by visiting the firm's Defective Hip Implants 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