For High Court, High Stakes Case on Preemption
by Matthew Madia, 11/5/2008
A case argued before the Supreme Court Monday could affect the way consumers seek redress from companies when harmed by faulty drugs. In Wyeth v. Levine, a woman claims Wyeth pharmaceuticals did not provide adequate warning of side effects for one of its drugs. Complications from the drug, phenergan, led to amputation of her arm.
Wyeth is arguing federal regulations serve as a shield which protects it from tort claims. The Food and Drug Administration approved the drug that led to the amputation of Levine's arm. Therefore, Wyeth's lawyers argue, it bears no responsibility for the ill effects of its drug.
That argument may seem reasonable at first glance, but those who oppose this sort of broad preemption — the legal doctrine whereby federal laws and regulation preempt decisions made at the state level, including in claims courts — look at the way liability affects society's incentive structures. Without the threat of liability, why would a drug company continue to monitor a drug's side effects or make efforts to improve the safety of a drug without sacrificing efficacy?
Moreover, federal laws and regulations, in this case drug safety laws and regulations, are proscriptive requirements and quite different from the kind of law that awards post hoc damages claims when harm occurs. It's apples and oranges.
Wyeth v. Levine was supposed to be a watershed case for preemption. However, justices appeared to be searching to narrow the ramifications of the case, according to the New York Times:
A broad endorsement of implied pre-emption based on regulators' actions rather than on statements in laws enacted by Congress could shut down countless injury suits in cases involving not only drugs but also motor vehicles, household products, chemicals and agricultural products.
Several justices appeared open to the idea that pre-emption could follow from the F.D.A.'s approval of a drug label — but only if drug companies remained subject to lawsuits if they failed to disclose new information about potential risks. There was much discussion of what information should be considered new.
Other justices seemed prepared to allow pre-emption — but only if the drug agency had considered the particular risk before approving the label.
Given the justices' interest in those refinements, the court seemed unlikely to rule broadly on the larger issues in the case: whether the agency and other federal regulators set minimum safety standards that states are free to augment or whether they make judgments about the optimal balance between risks and benefits that states must follow.
No indication yet of how the court might vote. The Los Angeles Times reported the judges seemed split.
