Case Notes
By Brendan M. Ford and Saleem K. Erakat
On March 4, 2009, the United States Supreme Court issued its long-awaited opinion in Wyeth v. Levine. This case was the most recent in the ongoing debate over federal preemption in the area of pharmaceutical and medical device products. Here, Wyeth presented a fundamental issue: does Food and Drug Administration (FDA) approval of a drug’s label preempt common law tort claims? By a 6-3 vote, the Supreme Court held that FDA approval of a drug label does not preempt state law tort claims.
By Eric E. Hudson
Product liability claims based on overseas production processes are the new reality for manufacturers. Recent cases involving claims of contaminated pet food and lead painted toys are just two examples of the growing number of cases involving allegedly deficient overseas processes. Most products practitioners are familiar with several recent MDLs involving these issues, but the application of insurance coverage to these claims is often overlooked. The recent decision of ACE American Insurance Co. v. RC2 Corporation, Inc., No. 07C5037 (N.D. Ill. June 26, 2008), focuses on coverage in these circumstances, and it highlights issues that products lawyers need to know.
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.
