For Immediate Release: April 22, 2009
Contact: Jen Fuson
202-965-3500, ext. 609
FDA "Internal Meeting" on Devices Shows Patient Safety at Risk
Medical Device Safety Act Needed to Restore Accountability of Manufacturers
Washington, DC—A report in The New York Times this morning indicating the Food and Drug Administration (FDA) is holding a rare “all-hands meeting” to discuss strategic issues in the medical device division of the agency is a further indication that safety approval of medical devices has been compromised, putting patients’ health and safety at risk according to the American Association for Justice (AAJ).
AAJ has been working in a large coalition of consumer and patient safety groups 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.
“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.
Michele Meyer of Cambridge, Minnesota lost her child Katie in December from complications related the removal of a defective medical device. The lead wires to her daughter’s defibrillator had fractured, causing the device to malfunction, sending painful shocks throughout Katie’s body. News reports indicate the device had never been tested in humans before being marketed and sold by Medtronic. The device was later recalled. Katie was just 31 years old and engaged to be married.
Last year in Riegel v. Medtronic the Supreme Court ruled medical device manufacturers have immunity from state tort suits if the device has been approved by the FDA’s pre-market approval process. The MDSA would restore the right to medical device patients as Congress had intended in 1976 when they passed legislation on medical device safety.
The Government Accountability Office reported in January that the FDA inadequately tested many class III medical devices. The study found in a recent five-year period the FDA did only minimal testing before approving 228 high-risk medical devices, instead of going through the agency’s more stringent premarket review process, as Congress had intended.
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 sponsors of the Medical Device Safety Act. Both Chairmen Kennedy and Waxman worked on the original Medical Device Amendments of 1976, authorizing the FDA to regulate medical devices.