Wyeth v. Levine: A Victory For the Doctrine of Preemption or Simply a Case of "Tragic Facts Making Bad Law"?
In Wyeth v. Levine, the Supreme Court recently ruled that state law tort suits are not preempted by the federal law governing drug labeling. The direct consequence of this decision is that drug manufacturers now clearly have the responsibility for the adequacy of their warning labels and, where state law allows, there will certainly be a rise in product liability suits aimed at drug companies.
The facts in Wyeth are important to understanding the Court’s opinion and should be reviewed by interested readers of this post. In brief, Ms. Levine brought a common law negligence claim against Wyeth on the theory that Wyeth’s warning label on a drug administered to her was not strong enough and that Wyeth could have revised its FDA-approved label to bar the specific use of the drug that caused her injury.
Wyeth’s argument to the Supreme Court centered on the theory that Ms. Levine’s common claims should have been preempted, because: “(1) Wyeth would have been unable to comply with both [State] common law duty to foreclose IV push injection and FDA’s directive, as evidenced by the drug’s approved label, to retain it; and (2) the claims would obstruct the full accomplishment of FDA’s risk-benefit objective to optimize use of Phenergan by imposition of a duty to foreclose IV push injection.”
Writing for the majority, Justice John Paul Stevens rejected Wyeth’s preemption argument, holding that “if Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express federal preemption provision at some point during the FDA’s 70-year history.” The court also declined to conclude that it was impossible for Wyeth to comply with federal and state requirements, absent clear evidence that the FDA would not have approved a change to the drug’s label.
Writing for the dissent, Justice Alito opened with the statement that "[t]his case illustrates that tragic facts make bad law.” Justice Alito’s central point being that the majority’s holding essentially approves of "drug labeling by jury verdict," which undermines the federal drug-labeling regime. In Justice Alito’s view, these types of cases present juries with tragic plaintiffs who were injured and lay juries are ill-equipped to deal with scientific and long-term public benefit issues involved in labeling drugs and federal regulators should be afforded deference in these cases.
Ultimately, the critical fact that influenced the Court was that Congress could have drafted the FDA statute to explicitly allow for federal preemption, but it did not do so (the majority opinion explicitly notes that an express preemption provision exists in the medical device context). Indeed, Justice Breyer in concurring opinion seemed to suggest that a future specific regulation by Congress or the FDA may have the preemptive effect sought by Wyeth. It will be interesting to see how Congress responds.
