The Medical Device Safety Act, introduced in March 2009, is aimed at reversing a 2008 US Supreme Court decision that found federal regulations preempt state-based liability claims challenging the design or labeling of medical devices that clear the FDA’s pre-market approval process.
Physicians who testified in support of the bill before the House Energy and Commerce Committee’s health subcommittee said the courts have helped promote patient safety by providing an important incentive for device makers to share accurate and timely information with the medical community and the public.
FDA approval alone does not guarantee safety, said William H. Maisel, MD, director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston. He cited a recent flood of recalls as an example of manufacturers’ failures to disclose defects in the pre-approval process, and he said limited resources continue to prevent the FDA from adequately monitoring the industry.
Representative Frank Pallone Jr. (D, N.J.), the bill’s sponsor, said the Supreme Court decision in Riegel v. Medtronic provided blanket immunity to device makers, while leaving patients with no recourse.
Representative Joseph R. Pitts (R, Pa.) disagreed, saying the court decision applied only to a small number of medical devices and does not preclude liability in cases in which a manufacturer misled the FDA. Products also are subject to FDA post-market reporting requirements.
Lay juries should not be permitted to second-guess the FDA’s scientific expertise, said food and drug lawyer Richard M. Cooper, former FDA counsel and now partner with Williams & Connolly LLP in Washington, D.C. If the bill were to pass, increased litigation costs could deter new development and limit patient access, he said.
