Fort Worth, Texas, Feb. 21, 2012 – Parker McDonald, P.C. reports on a recent investigation by The New York Times which found that healthcare giant Johnson & Johnson continued to market its DePuy ASR Hip Resurfacing System overseas after it was rejected by the Food and Drug Administration in the United States.
According to The New York Times, in a confidential letter sent to Johnson & Johnson, the F.D.A. told the company that studies and clinical data submitted to gain approval in the United States were inadequate to determine its effectiveness and safety. Johnson & Johnson continued to market the device overseas without notifying regulatory agencies, nor did the company address the nonapproval letter in financial reports or in presentations to analysts. Even so, it is not suggested that Johnson & Johnson violated the law.
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.
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, www.hipimplantrecovery.com, to provide the latest information for concerned defective hip implant patients and their families.
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