Does the FDA's premarket approval of a medical device effectively immunize the manufacturer from liability for injuries caused by the device? The courts are deeply divded over this question of federal preemption. The pending cert petition in Riegel v. Medtronic, a case in which I represent the petitioners, offers the Supreme Court a chance to resolve that division and answer the question once and for all. We filed our reply brief earlier this week and expect to find out on November 6 whether the Court will take the case.
Since the early 1990's, defendants have been arguing, and the federal courts have often held, that damages actions brought by consumers against medical device manufacturers are preempted by the 1976 Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act. Without getting into its complexities, the MDA's preemption provision, 21 U.S.C. 360k(a), provides that certain federal requirements applicable to medical devices preempt certain state-law medical device requirements.
We've been fighting these arguments for years. In Medtronic v. Lohr, 518 U.S. 470 (1996), a case argued by my colleague Brian Wolfman, the Supreme Court rejected an attempt by a medical device manufacturer to immunize itself from tort liability by pointing to this preemption provision. The Court held that, for the MDA to preempt a common-law claim, that claim must be developed "with respect to" devices and must correspond to a device-specific federal requirement.
Continue reading "Should FDA Premarket Approval Be a Liability Shield?" »





