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Thousands of people who received a metal-on-metal version of DePuy Orthopaedics' Pinnacle Hip System have filed DePuy Pinnacle hip replacement lawsuits seeking compensation for injuries they claim were the result of the hip's all-metal design. According to a Master Case list posted by the Court in March 2013, just under 4,000 such claims were pending in a federal multidistrict litigation now underway in U.S. District Court, Northern District of Texas. The DePuy Pinnacle hip is a modular hip replacement system that can utilize a number of different liners. When it is used with the Ultamet linter, the Pinnacle becomes a metal-on-metal hip implant. Metal-on-metal hips are currently being reviewed by the U.S. Food & Drug Administration (FDA) amid concerns that they can shed dangerous amounts of metal ions into the surrounding tissue and blood stream. According to DePuy Pinnacle hip replacement lawsuits, this can lead to metallosis, early failure of the hip, and other long-term health problems down the road. Metal-on-metal hip implants like the Pinnacle were allowed to come to market without human testing under the FDA's 510(k) approval system. This system allows for moderate risk medical devices to forgo human clinical trials if their design is substantially equivalent to another already on the market. After the problems with all-metal hips became apparent, the FDA proposed a new rule that would make these devices ineligible for 510(k) approvals. Plaintiffs in DePuy Pinnacle lawsuits claim they have suffered a number of complications due to the metal ions shed from the hip, including: • Pain • Elevated levels of cobalt and chromium in their blood streams • Fluid-filled cysts under the skin called pseudotumors • Soft tissue necrosis • Loosening of the hip implant • Dislocation of the hip implant • Infection • Bone fracture • The need for revision surgery In August 2010, DePuy Orthopaedics recalled another of its metal-on-metal hips, the ASR, after it was found to be failing prematurely in a high number of patients. However, even though plaintiffs in DePuy Pinnacle lawsuit claim the metal-on-metal version suffers from the same design flaws, the company has not issued a recall for that device. Federal DePuy Pinnacle claims have been consolidated before a single judge in the Northern District of Texas in order to conserve the resources of the court and avoid conflicting rulings in the lawsuits.The judge overseeing the litigation has scheduled its first trial for September 2014.
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