Tuesday, July 12, 2011

DePuy Hip Leads to Lawsuits

The DePuy Pinnacle Acetabular Cup System, which is used in total hip replacements, is manufactured and sold by DePuy Orthopedics, a subsidiary of Johnson & Johnson. The system consists of a porous coated hemispherical outer shell and a liner that locks into the outer shell, which can be either polyethylene or metal. The liner component articulates with the femoral head, which is typically metal. Metal-on-metal hip replacements, which use cobalt and chromium in their construction, currently account for about one-third of the 250,000 hip replacements performed each year in the United States. However, in recent years, concerns over problems with metal-on-metal hip replacements have been growing. Patients are requiring a second DePuy hip revision surgery, which is a painful lengthy process.

On May 6, the FDA ordered hip implant makers to conduct post market studies to gather data on the levels of metal in the blood of people who have received their hip implants and what health effects those implants might have. The agency sent a total of 145 post market surveillance orders to 21 different manufacturers, including DePuy Orthopedics, Zimmer and Stryker. When a metal liner is used, the metal-on-metal DePuy Pinnacle design can cause small metal particles and debris to be shed into a patient’s body and tissue as the metal parts wear against each other, potentially resulting in metallosis or DePuy metal poisoning. This can damage the muscles and other soft tissue potentially resulting in early failure of the DePuy Pinnacle hip within a few years after it is implanted, often resulting in the need for hip revision surgery.

Hundreds of individuals throughout the United States have already filed DePuy hip lawsuits over problems allegedly caused by metallosis or metal poisoning. All DePuy ASR hip lawsuits have been consolidated in federal court as part of an MDL, or multidistrict litigation. In addition, a petition is currently pending for a similar centralization order for a growing number of lawsuits over DePuy Pinnacle hip replacements, which is another metal-on-metal implant. Although there appears to be ample evidence that should have led to a DePuy Pinnacle hip recall being issued, the metal-on-metal hip replacement system remains on the market and consumers continue to be exposed to the risk of serious and debilitating problems.

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