Today, the U.S. Senate’s Special Committee on Aging will hold a hearing to review the approval process currently in place by the U.S. Food and Drug Administration (“FDA”) in response to the vast number of defective medical devices that have made their way into the marketplace.  Recently, the FDA has been the target of increased media scrutiny as drug and medical device manufacturers continue to use the 510(k) loophole in order to receive clearance for their medical devices.  Although the panel will review the FDA’s general internal procedures for approving medical devices, the hearing is expected to focus primarily on the recalled DePuy hip implants, as they are the most glaring example of a failed regulatory process.  The DePuy hip implants received FDA approval through the 510(k) process.  Among those expected to testify at tomorrow’s hearing include:  a patient who received a defective DePuy hip implant, patient safety advocates with expertise on the 510(k) process, the chief science officer for the FDA’s Center for Devices & Radiological Health and other experts on medical devices.  Since the massive recall of DePuy’s ASR hip implants last August, lawsuits against the manufacturer have sprung up nationwide.  Clearly, the aftermath of this debacle has been disastrous for Johnson & Johnson, DePuy’s parent company.  J&J could potentially pay out billions of dollars to injured victims.   For some time, many have wondered whether J&J will survive this catastrophe.  Today’s hearing may prove that DePuy’s careless disregard for consumer safety will extend further, taking the FDA down too.  Stay tuned for further updates.

Published April 13, 2011 by