Whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer's proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning.
Some observers have speculated that the forthcoming decision in Merck could substantially narrow the Supreme Court's ruling in Wyeth v. Levine (2009). Wyeth held that state-law failure-to-warn suits over mislabeled prescription drugs generally are not preempted by federal law, and are preempted only in very limited circumstances — where the FDA would have rejected (or, presumably, has rejected) the very warning that the plaintiff maintains would have prevented her injuries. As I read the transcript from yesterday's argument in Merck, it does not seem that an earth shattering ruling is in the offing. It appears that the Justices generally accept Wyeth's basic holding and are struggling with how it applies to the idiosyncratic facts presented in Merck.