While DePuy Lawsuits Go International, FDA Requests More Information

Washington, DCWhile lawsuits concerning DePuy Hip Replacement devices have taken on an international angle, the US Food and Drug Administration (FDA) has told device makers, including the maker of the DePuy hip, to study data about the hip replacement devices. Lawsuits concerning the DePuy hip have already been filed in the US, although more lawsuits are expected to be filed as more patients experience failure of their DePuy hip replacement devices.

Internationally, lawsuits have been filed against DePuy in Australia and the United Kingdom. An article run in The Guardian (05/16/11), quotes Deb Cohen of the BMJ (British Medical Journal) as saying that "[the DePuy hip implant] is one of the biggest disasters in orthopaedic history, according to one surgeon."

Meanwhile, the FDA has ordered makers of metal-on-metal hip replacement devices to study patients who received the devices. The goal will be to determine whether patients are experiencing complications, including metallic debris. That metallic debris is reportedly caused by normal wear and tear of the metal-on-metal devices, but the debris can be absorbed by surrounding tissue, causing pain, soft tissue damage and failure of the hip replacement device.

According to The New York Times (05/10/11), the concern is not just about one manufacturer, but about the overall product; hip replacement devices that involve ball-and-socket components that are both made from metal. Often, the metal used is cobalt or chromium. The metal-on-metal devices were believed to be more durable and resilient, ideal for younger hip replacement patients who lived active lives.

The metal-on-metal devices, however, reportedly have a high failure rate; the British Orthopaedic Association estimated that the DePuy hip could fail in up to 50 percent of patients within six years of implantation.

Companies that manufacture metal-on-metal hip replacement devices have been asked to collect blood samples from patients who receive the devices to determine the levels of metal in their systems. According to some reports, that level could run high.

Earlier in 2011, the US Senate Special Committee on Aging met to discuss how the FDA oversees medical devices. One witness for the committee, Katie Korgaokar, testified that she received the DePuy ASR prosthetic hip. After the device was recalled, Korgaokar was told she should have a blood test. That blood test revealed her cobalt and chromium levels were 1,000 percent above normal—and she had to have the hip replacement device removed. Korgaokar said her revision surgery was more difficult than the initial replacement surgery, involving more pain and limited mobility. Eventually, Korgaokar learned that her surgeon received hundreds of thousands of dollars in consulting income from DePuy, but did not disclose that information prior to her surgery.

Lawsuits have been filed against DePuy, with patients alleging they suffered serious side effects due to the failure of the hip replacement devices.