Case Notes
Riegel v. Medtronic, Inc.: Manufacturers of PMA Devices Entitled to Preemption Defense
By Caryn M. Silverman
The U. S. Supreme Court, by an 8-to-1 majority, recently held that the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. 360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that have received premarket approval (PMA) from the Food and Drug Administration. Thus, plaintiffs who have brought suits for injuries allegedly sustained as a result of a PMA device now confront a preemption defense that should bar most state tort claims. In reaching this result, the Supreme Court distinguished its decision in Medtronic v. Lohr, 518 U.S. 470 (1996) where it held that a finding by the FDA of “substantial equivalence” under § 510(k) did not preempt state-law tort claims based on the use of such medical devices.
Simonetta v. Viad Corp: A Disturbing Expansion of the Duty to Warn in Products Liability Cases
By Gregory D. Shelton and R. Joseph Sexton
A product manufacturer generally is not liable for failing to warn consumers
of the dangerous nature of a product designed and sold by a third party. A recent
decision from the Court of Appeals for the State of Washington, Simonetta
v. Viad Corp., alters this general rule. It is no longer sufficient for
a manufacturer to investigate its own product and issue warnings based on potential
dangers its product might present. Manufacturers are now responsible for dangers
related to other products that may be used in conjunction with, or in close proximity
to, their products; and are obliged warn the consumer about those dangers.
