DePuy Executive Discussed Hip Implant Failure Rates
Posted on behalf of Phillips Law Group on Feb 24, 2012 in Defective Products
A year before DePuy's hip implant was recalled, DePuy executive, Pamela Plouhar wrote in an internal email that the Food and Drug Administration (FDA) refused to approve the device. The refusal came after reviewing studies that showed a significant failure rate in the device which required repeat surgeries. DePuy Orthopaedics is subsidiary of Johnson & Johnson. The New York Times reports that the 2009 email refutes Johnson & Johnson's claims that the product was safe, prior to the recall in 2010. The device that was rejected by the FDA was only sold overseas, but a companion version that was recalled at the same time was used in 30,000 patients in the U.S.
In the email, Plouhar cautioned that providing the FDA more data about the hip device would probably not change their decision and it might take years to do new studies on the articular surface replacement (ASR). The ASR had a high failure rate compared to other artificial hips. The ASR was also known to leave metal debris in the patient's tissue. Plouhar also discussed in the email that regulators in Australia were pressuring the company to take the hip implant off the market due to failure rates.
Johnson & Johnson began selling the DePuy ASR Hip Replacement abroad in 2003. Since resurfacing was a new procedure, the FDA required DePuy to conduct clinical trials. DePuy used a loophole in 2005 to start marketing a version of the implant in the U.S. in standard hip replacement surgery. Both versions of the device use the same critical component, a metal cup that is placed in the hip socket.
Plouhar's email is one of thousands of company documents released under a court-ordered seal to lawyers suing the company. There are currently 5,000 lawsuits pending against the company.
If you or a loved one has been injured after using a DePuy hip implant, you may be entitled to compensation for your medical bills, pain and suffering and other losses. Contact the attorneys at Phillips Law Group to discuss your legal options. The law firm is offering free case reviews to the injured.