FDA Needs More Oversight of Defective Medical Device Recalls to Prevent Adverse Events
A new report from the Government Accountability Office reveals that the U.S. Food and Drug Administration is not doing enough to follow up on defective medical devices, such as the recently recalled DePuy hip replacement system, that cause deadly side effects. Our Illinois product liability attorneys know that recalls are an important tool to prevent safety problems associated with defective devices. But more needs to be done in order to mitigate patient harm. The latest government report shows that the FDA is missing an important opportunity to protect consumers from medical devices that cause serious personal injury or death.
According to the report, more than 700 defective medical devices are recalled every year, and many of these devices carry a serious health risk. Cardiac devices are most commonly recalled, along with radiology devices. In 2010, a hip replacement system manufactured by DePuy Orthopedics hip replacement system was recalled, and hundreds of lawsuits are pending against the medical device manufacturer. Studies show that 1 in 8 patients who received a recalled DePuy hip required a second, painful revision surgery. Zimmer's NexGen line of knee replacement systems was also recently recalled, after patients experienced loosening and severe pain.
Even after these dangerous medical device products are recalled, the danger remains. The FDA is not doing its part to ensure that the recalled devices are off pharmacy shelves or hospital inventories. Surprisingly, the agency has no way of assessing whether or not manufacturers actually pulled every recalled device off the market. The report found several cases in which dangerous medical devices could not be located, and manufacturers just assumed that consumers threw them away.
This report is troubling because a significant number of recalled devices cause serious adverse health problems, and the FDA's lack of oversight exposes patients to unnecessary risk. Defective device patients and medical providers need to be consistently informed about potential product hazards in order to prevent permanent harm.




