The Safe Medical Device Acts Impacts The DePuy Recall

The DePuy hip replacement recall affects 93,000 recipients of the ASR XL Acetabular System and the ASR Hip Resurfacing System. Both these devices fail 12 to 13 percent of the time after five years. Already hundreds—and it’s commonly predicted that thousands—have filed hip replacement lawsuits against DePuy. Many people affected by the recall may want an introduction to the Safe Medical Devices Act of 1990 to learn how it affects the recall.

When a hospital, out-patient surgical office, or other location where a hip replacement procedure is performed (called Medical Device User Facilities (DUFs) in the statute) suspects that the device has injured a recipient, it must send a report to the following: the Secretary of Health and Human Services, the device’s manufacturer, or both.

Hip replacement manufacturers are required to submit a “summary of, and citation to,” any information known or available to them about these devices including adverse data on safety and effectiveness. Manufacturers are also required to report corrections and removals of devices to the Secretary of Health and Human Services if the purpose is to reduce a health risk.

DUFs sent the FDA hundreds of reports regarding DePuy’s implants’ high failure rates at least two years before the recall. As for the health risks the devices posed, DePuy voluntarily removed them from the Australian market in 2007 because of complaints and reports from its artificial joint registry. It wasn’t until March of 2010 that DePuy ceased sales in the United States, but this was due to “slow sales” and not because DePuy negligently manufactured the devices. It wasn’t until August of 2010 that it initiated the embarrassing worldwide hip replacement recall. The gap between the 2007 market removal in Australia and the same in 2010 in the U.S. suggests that DePuy was well aware of its devices’ failure rates. Whether it reported the adverse data to Health and Human Services during this period is unknown.

There is some likelihood that DePuy Orthopaedics violated federal law by not acknowledging DUF reports and by not reporting adverse problems with its implants. Simply put, it negligently manufactured its hip replacements, and it only offers to pay you for the “reasonable and customary” costs associated with the recall. If you would like to negotiate or sue for more compensation, contact a lawyer at the Rottenstein Law Group.