Federal legislators are introducing new bills that would allow patients to once again file lawsuits over injuries from flawed or unsafe medical devices, the New York Times reported Feb. 19. The bills are necessary because of a February 2008 Supreme Court decision in Riegel v. Medtronic Inc. (PDF), which found that defective medical device lawsuits based on state claims are preempted by explicit language in federal law. The decision barred most, if not all, medical device claims, leaving patients at the mercy of a flawed FDA approval process.
The article starts with the story of the Turnidge family, which lost father Mark Turnidge in January. Turnidge, 33, had an internal defibrillator implanted into his heart, which was intended to regulate his heartbeat. Because of a break in the device that could have caused random, repeated electric shocks to his heart, Turnidge decided to have it surgically removed — but the surgery went wrong. Turnidge died, leaving wife Wendy and two young boys behind. Wendy Turnidge is considering a medical malpractice lawsuit as well as a dangerous medical device lawsuit against Medtronic, the maker of the flawed defibrillator that made the surgery necessary. But thanks to the Riegel decision, a Medtronic lawsuit would almost certainly be dismissed unless Congress takes action.
Preemption is a legal doctrine that says federal law trumps the laws of states and local governments. If a federal law preempts a state law, following that federal law should protect individuals and businesses from criminal or civil liability for not following state laws on the same subject, including state negligence claims. The Riegel decision found that language in the Medical Devices Amendments of 1976 explicitly preempted state claims. (This makes it distinct from the court’s more recent decision in Wyeth v. Levine, in which the pharmaceutical company argued that the law implied, but did not outright specify, preemption.)
As the Times reported, this decision left medical device patients to rely wholly on FDA regulators to prevent serious injuries or even deaths from medical device defects. That would be more reassuring if so many medications and medical devices had not been recalled in recent years due to serious safety flaws, and if we had not seen so many reports of political and industry influence trumping science at the agency. As a pharmaceutical liability attorney, I have seen patients killed, disabled or diagnosed with lifelong serious health conditions because of injuries from FDA-approved medicines and devices. I do not believe FDA approval is enough to ensure safety, at least at the moment.
Based in St. Louis, Carey, Danis & Lowe represents clients in Missouri and throughout the nation in defective medical device litigation and dangerous prescription drug claims. If you or someone you love has been hurt by a pharmaceutical product and you’d like to talk with us about legal action, please contact us online or call us toll-free at 1-877-678-3400.
