With Ferrari currently before the Supreme Court on certiorari, the after-created direct split between the federal court of appeals and a state's highest court on a question of federal preemption raises the prospect of yet another High Court preemption battle regarding an FDA-approved product. That is, if the Court is willing to revisit preemption in the FDA context so soon after deciding three cases in a year.
Bruesewitz addresses and distinguishes Wyeth v. Levine as follows:
In Wyeth v. Levine, S. Ct. 8 , No. 06-1249, 2009 WL529172, at *1 (2009), the Supreme Court examined whether federal law preempted state tort claims alleging that a drug manufacturer failed to adequately warn of the dangers associated with a drug. Id. at *1. Though we recognize that the Supreme Court concluded that state tort law claims were not preempted in that case, id. at 13, Levine is readily distinguishable on several grounds. First, the Court explicitly noted the absence of an express preemption provision and found Congress’s silence, “coupled with its certain awareness of the prevalence of state tort litigation,  powerful evidence.” Id. at 10. In this case, however, Congress included an express preemption provision that was prompted, as evidenced by the Committee Report, by the prevalence of state tort litigation. Second, it recognized that, under federal law, a drug manufacturer could strengthen a drug's label without preapproval from the FDA. Id. at 7. This stands in contrast to the FDA’s far-more extensive control and oversight of the approval of a drug’s design and alteration.
Slip op. at 30-31 n.8.
The court, examining the history of Vaccine Act, concluded that Congress intended to apply Restatement (Second) of Torts §402A, comment k (1965) across the board to bar all design defect claims, whether sounding in negligence or strict liability, against vaccines covered by the Act. Slip op. at 33-35. An attempt by a committee of a later congress to undercut preemption was rejected. Slip op. at 36-40.
For additional information on Vaccine Act preemption, the Washington Legal Foundation, recently released an interesting "Legal Backgrounder."