Wyeth v. Levine: States' Rights Trump Federal Pre-emption

This morning, the U.S. Supreme Court announced a 6-3 decision in favor of the plaintiff in Wyeth v. Levine. The case addressed whether the Vermont Supreme Court erred in upholding damages, based on Vermont's product-liability law, against Wyeth for supplying a drug without adequate warning of its risks. I've written a series of blog entries on this case, expressing great dissatisfaction with Wyeth's argument that the federal government should exert a legal monopoly over information that a drug-maker can put on its label.

The Supremes' majority held that Wyeth promoted a "cramped reading" of pre-emption in the Food, Drug, & Cosmetics Act, and noted that Congress had never asserted the FDA's pre-emptive power. Rather, this was inserted by the Bush Administration in regulatory language as recently as 2006. Finding no Congressional intent to pre-empt, the majority found against Wyeth. The majority also found that the FDA erected no legal obstacle to Wyeth's amending its label to conform to Vermont law.

Concurring, Judge Clarence Thomas went even further. (Thanks to a Lexis/Nexis subscription, I've been able to read the whole decision.) While the majority suggests that Congress could have asserted pre-emption if it wanted to, Thomas argues that the 10th amendment to the U.S. Constitution deprives the Congress power to pre-empt states' product-liability laws at all. Thus, he finds himself in opposition to other cases where the Court has upheld pre-emption.

So, Wyeth's (and, by extension, the research-based pharmaceutical industry's) campaign for pre-emption has ground to a halt. And it is not likely to pick up steam under President Obama and the current Congress, who surely favor trial lawyers.

Defeat? No: Rather an opportunity to re-think creative ways to reform product-liability law while preserving states' sovereignty, as I've suggested before.

(Although, I have changed my mind on this issue at least once: See this link and this link.)