Back in November, I wrote about the pending Supreme Court case Wyeth v. Levine, the decision in which will have a huge impact on the pharmaceutical industry and the law of federal preemption. The plaintiff in that case, Diana Levine, was injured when a physician’s assistant improperly injected a Wyeth-made drug into Levine’s artery despite a clear, FDA-approved label statement warning against possible risks from arterial injection.
Levine and her lawyers were nevertheless able to convince a Vermont jury that FDA’s approval of the label warning should not preclude her claim under Vermont tort law that Wyeth acted negligently. Wyeth, on the other hand, argued that the explicit FDA approval of the label statement should preempt Vermont law, since Congress delegated to FDA the authority to carefully examine the risks and benefits of medical drugs and determine whether they are, on balance, safe enough for doctors and their patients to use. In November, the United States Supreme Court heard oral argument on the preemption question, and a decision in the case is expected some time this spring.
One of Wyeth’s attorneys in the case is Bert Rein, éminence grise in the Washington legal scene and a founding partner of the highly regarded firm Wiley-Rein. Bert is a long-time friend of the Competitive Enterprise Institute, and he and other Wiley-Rein attorneys have done pro bono work for CEI in past years. So, I am happy to announce that Bert has agreed to contribute a few guest blog posts to Open Market discussing the importance of this case. His first post will appear later this morning.