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In addition to the rising number of claims filed over similarly designed metal-on-metal hip devices, there are now over 3,800 hip replacement lawsuits brought by patients who received a version of the DePuy Pinnacle hip replacement that includes a metal Ultamet liner. Approved by the U.S. Food and Drug Administration (FDA) in 2005, court records indicate that many of the cases filed over this implant are pending in a federal multidistrict litigation (MDL) underway in the U.S. District Court for the Northern District of Texas. The first trials in the federal DePuy Pinnacle litigation will begin in September 2014. Almost 11,000 cases have also been filed over another hip replacement marketed by the Johnson & Johnson subsidiary, according to a recent report from Bloomberg.com. After post-surveillance data indicated the potential for the cobalt and chromium components to fret and corrode, approximately 93,000 DePuy ASR metal-on-metal hip replacement devices were affected by the DePuy ASR hip recall. As the number of DePuy hip replacement lawsuits continues to rise, Consumers Union has taken action in changing the way metal-on-metal hips are approved by the FDA. In a comment letter sent to the U.S. Food and Drug Administration (FDA), MarketWatch.com reported on April 18th that Consumers Union has urged the agency to adopt new regulations that would require manufacturers of this class of devices to submit pre-market approval for all new designs. 11,000 consumers signed the letter sent by Consumers Union. For implants that already entered the market, new regulations would require companies to provide the agency with clinical testing results proving their safety and effectiveness within 90 days. This would make metal hip devices ineligible to receive clearance through the FDA’s 510(k) process, which allows a product to receive approval if its manufacturer can prove it to be equivalent to one already on the market. The version of the DePuy Pinnacle that includes a metal Ultamet liner was approved by the FDA via its 510(k) clearance program.
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