The New York Times recently has published an internal email from an executive at DePuy.
Fort Worth, TX February 27, 2012
Parker McDonald, P.C. recently reported on The New York Times investigation which showed DePuy Orthopaedics, Inc. continued to market one of its hip devices after it was rejected by the Food and Drug Administration. On February 21, 2012, The New York Times published an internal email that Pamela Plouhar, vice president for worldwide clinical affairs at DePuy, sent regarding a “non-approval” letter from the FDA revolving around a DePuy hip device.
In the email Pamela Plouhar explained that the FDA refused to approve the ASR Hip Resurfacing System due to company studies showing that there were “…a significant number of revisions within the ASR group…as opposed to very few in the control group.” According to the New York Times, these statements contradict those made by DePuy and Johnson & Johnson in recent years.
DePuy continued to market the device overseas without notifying regulatory agencies, nor did the company address the non-approval letter to patients or doctors. Even so, it is not suggested that either DePuy or Johnson & Johnson violated the law.
According to The New York Times, DePuy placed the failure of the ASR on orthopedic surgeons and maintained its safety and effectiveness. However, the findings rejected by the FDA came from ASR studies performed by surgeons chosen by DePuy, including some who had developed it.
Another model in the ASR hip device family, the DePuy ASR XL Acetabular Hip System, was cleared for use in the U.S. in 2005 through the highly controversial 510(k) process. The company used the 510(k) clearance process to fast track its XL Acetabular Hip System without conducting clinical trials, because DePuy claimed it was “substantially equivalent” to a device previously marketed in the U.S.
The New York Times reports that documents dated from September 2009, just weeks after the FDA’s decision, “…indicate that top DePuy executives decided to phase out the device.” DePuy executives reportedly made this decision based on declining ASR sales while maintaining that the device was safe.
In August of 2010, DePuy voluntarily recalled both of its ASR hip replacement systems – the ASR XL Acetabular Hip Replacement System and the ASR Hip Resurfacing System. This recall came after data from the National Joint Registry of England and Wales indicated that the five-year failure rate of these products is approximately 13 percent, or 1 in 8 patients. Symptoms include severe pain, implant loosening, implant dislocation, and toxic heavy metal poisoning. The recall in the United States came nearly a year after the company withdrew the device from the Australian market.
Parker McDonald currently represents hundreds of clients across the country who have received the DePuy ASR XL Acetabular Hip System. The firm has established a website, http://www.hipimplantrecovery.com, to provide the latest information for concerned defective hip implant patients and their families.
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