Rare FDA Meeting to Discuss Unsafe Medical Devices

Will Parker — Tue, 28 Apr 2009 13:03:09 GMT

This morning, The New York Times reported the Food and Drug Administration (FDA) is holding an extremely rare “all-hands" meeting to discuss strategic issues in the much criticized medical device division of the agency. This signals further indication that safety approval of medical devices has been compromised, which jeopardizes patients’ health and safety, according to the AAJ (American Association for Justice).

AAJ and others have been hard at work in an attempt to enact the Medical Device Safety Act (MDSA), legislation that would restore the rights of medical device patients to seek justice in state courts when they have been harmed by unsafe medical devices. Currently, FDA approved devices are off-limits to civil suits. That, in and of itself, should alarm the American public. However, add in the recent alleged failures of the FDA's device department and the results should shock the conscious of American citizens.

In essence, the result are as follows: FDA has approved dangerous devices that have not been adequately tested AND people have been injured or have died BUT the injured victims and family of the deceased have NO LEGAL RECOURSE.

A real-life example involves Michele Meyer of Cambridge, Minnesota. She lost her child, Katie, in December from complications related the removal of a defective medical device. The lead wires to her daughter’s defibrillator fractured, causing the device to malfunction. This sent painful shocks throughout Katie’s body. News reports indicate the device had never been tested in humans before being marketed and sold by the manufacturer, Medtronic. The device was later recalled. This was little recourse for her family and future husband, as Katie was just 31 years old and was engaged to be married.

So how does the civil justice system play into this scenario?

“The civil justice system provides an added check on manufacturers to hold them accountable for the safety of the products they produce and profit from,” said Sue Steinman, Director of Policy at AAJ. “With the FDA’s medical device division’s integrity in question, it is even more imperative medical device patients have an added layer of protection through the civil justice system,” added Steinman. “We hope Congress will act quickly to restore the rights of medical device patients to hold manufacturers accountable for products that injure patients,” added Steinman.

Senator Edward Kennedy (D-MA), Chairman of the Senate Health, Education, Labor and Pensions Committee and Rep. Frank Pallone (D-NJ) and U.S. House Energy and Commerce Committee Chairman Henry Waxman (D-CA) are co-sponsors of the Medical Device Safety Act. Both Kennedy and Waxman worked on the original Medical Device Amendments of 1976, which authorized the FDA to regulate medical devices. Neither could have contemplated the alleged inadequate testing currently taking place and the resulting injuries and deaths as a result of the inadequate testing and regulation.

Originally posted at InjuryBoard by Will Parker

Florence-Myrtle Beach Personal Injury Lawyer - Medical Devices & Implants

Rare FDA Meeting to Discuss Unsafe Medical Devices