Last week the Supreme Court issued its decision in Wyeth v. Levine, 2009 WL 529172 (U.S. Vt.), which affirmed the Vermont Supreme Court’s ruling that Diana Levine’s state law claims alleging defective pharmaceutical packaging were not preempted by federal law. Justice John Paul Stevens wrote the 6–3 majority opinion, Justices Stephen Breyer and Clarence Thomas wrote separate concurrences, and Justice Samuel Alito wrote a dissent in which Chief Justice John Roberts joined. Here is my post from when the case was argued last November.
The Court rejected Wyeth’s theories that first, it could not have modified the label placed on the drug once it was approved by the Food and Drug Administration and that Wyeth could not comply with both state laws regarding failure-to-warn and federal labeling duties and second, that requiring Wyeth to comply with a state law requiring a stronger warning than that approved by the FDA would obstruct the purposes and objectives of federal drug labeling regulations.
Here are SCOTUSBlog’s initial post about the decision and its analysis. And here is The Wall Street Journal Law Blog’s discussion, which includes an interview with the paper’s Supreme Court reporter, Jess Bravin, and places Wyeth in the context of earlier federal preemption decisions.
Other blog posts include this one from the Drug and Device Law blog, which concludes that Levine doesn’t make preemption impossible, just more difficult, and this one from the Pharmaceutical Executive blog, which describes Wyeth as having "walloped" the pharmaceutical industry.
Since the case was argued, Pfizer has announced that it is acquiring Wyeth (here is Wyeth’s press release about the acquisition, which has far more information than anyone could possibly want or need), so Wyeth will cease to exist as an independent company, but I tend to agree with those who have suggested that Wyeth’s counsel, whether in-house or outside, made a bad decision in appealing from the Vermont Supreme Court, given the nature and circumstances of Ms. Levine’s injury. I realize it’s easy to make that observation now that the Court has ruled, but all things considered, Wyeth should have settled with Ms. Levine — her verdict was $6.7 million — and avoided the risk of making bad law.