DePuy Sold Defective Implants to Clear Out Inventory

Johnson &Johnson decided to sell all the defective DePuy ASR hip implants in its inventory before discontinuing the devices, even after the U.S. Food and Drug Administration (FDA) raised concerns about its safety in 2009, The New York Times has reported.
The U.S. Food and Drug Administration (FDA) approved DePuy’s ASR XL total hip replacement system in 2005 through the 510(k) process, which doesn’t require testing on humans. Two years later, the Johnson &Johnson subsidiary filed a Premarket Approval Application (PMA) for the hip resurfacing version of the device. This clearance does require more rigorous and lengthy testing. In August 2009, DePuy received a confidential non-approvable letter for the DePuy ASR Hip Resurfacing System.The newspaper reported in February 2012 that an executive at Johnson &Johnson admitted in an internal email that the FDA refused to approve the device because studies showed it failed prematurely in high numbers of patients, requiring revision surgeries. In other words, it was a safety issue.However, DePuy President Andrew Ekdahl maintains the reason the hip implant was pulled from the overseas market — where it was being used by doctors because of a less rigorous approval process — was a business decision.The New York Times points out that DePuy repeatedly insisted the resurfacing system was safe and refuted complaints from surgeons. But the internal email reporting “significant” failure rates was written in August 2009, a full year before the company recalled both DePuy ASR systems.Furthermore, at the same time the FDA rejected DePuy’s PMA for the ASR Hip Resurfacing System, it told the company that blood tests of patients with the all-metal hip showed a “high concentration of metal ions,” The New York Times reports. The newspaper obtained the confidential non-approvable letter under the Freedom of Information Act.
A recent study by researchers at the University of Bristol cements the FDA’s concerns, linking faulty metal-on-metal hip replacement systems to possible kidney and bladder cancers The findings suggest that the metal shavings made up of cobalt and chromium — produced when parts grind against each other — cause changes to cells that could be precursors to cancer in 20 percent of patients with all-metal hip-replacement systems. In addition, the metal particles have been blamed for tissue damage, tumors, high metal ion blood counts and metal blood poisoning.DePuy did not recall either version of the ASR metal hip implants until August 2010, a year after the FDA letter. About 93,000 patients worldwide received the artificial hips.