On Tuesday, August 4, 2009, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing to debate a bill known as S.540 – the Medical Device Safety Act of 2009.
Last year, in Riegel v. Medtronic, 552 U.S. —, 128 S.Ct. 999 (2008), the United States Supreme Court held that the express preemption provision in the Medical Device Amendments (“MDA”) to the Food, Drug and Cosmetic Act (“FDCA”) bars lawsuits against manufacturers of medical devices that underwent the Food and Drug Administration’s “rigorous” pre-market approval process. See our June 2008 Blog on Riegel. The bill debated yesterday would amend the MDA’s express preemption provision to prevent it from being construed as barring lawsuits or damage claims for personal injury.
Consumers and healthcare professionals had an opportunity during the hearing to express their viewpoints, with several consumers, who have suffered injuries as a result of defective pacemakers and defibrillators, testifying about the need to be given access to the courthouse and to hold manufacturers responsible for mistakes and oversights. Physicians and tort reformers, on the other hand, repeated a familiar – and illusory – refrain: permitting lawsuits stifles innovation and invites juries to second-guess the FDA’s decision-making. Never mind that device manufacturers, just like drug makers, have been defending legal actions over their products for decades, with no empirical evidence to suggest that their collective innovation has lagged or failed to reach its full potential. And never mind that the FDA’s “decision-making” over the last decade has not exactly been beyond reproach (see, e.g., the Vioxx debacle).
Although similar bills were proposed in the House of Representatives last year and earlier this year, the current version is a Senate bill that is being sponsored by Senators Ted Kennedy (D-Mass) and Tom Harkin (D-IA). The full text of the bill is available here: S. 540: Medical Device Safety Act of 2009.