Bruesewitz v. Wyeth LLC, 131 S. Ct. 1068 (2011), and Williamson v. Mazda Motor of America, Inc.., 131 S. Ct. 1131 (2011). On February 22, 2011, the Supreme Court of the United States ruled 6-2 in Bruesewitz that the National Child Vaccine Injury Act (“NCVIA”) preempts all design-defect claims against vaccine manufacturers by plaintiffs who seek damages for harm caused by a vaccine’s side effects. Justice Scalia wrote the majority opinion, while Justice Sotomayor, joined by Justice Ginsburg, dissented. The next day, the Court ruled unanimously in Williamson, in an opinion by Justice Breyer, that a federal motor vehicle safety standard, FMVSS 208, did not preempt state tort actions asserting that auto manufacturers should have installed lap-and-shoulder belts, instead of lap belts alone, on rear inner seats of their vehicles. Justices Thomas and Sotomayor each filed concurring opinions. Justice Kagan did not participate in either case.
Bruesewitz turned largely on a provision of the NCVIA that exempted vaccine manufacturers from liability for a vaccine-related injury or death “if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” Justice Scalia concluded that, based on that language, as long as “there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable. State-law design-defect claims are therefore preempted.”
Williamson was preceded by Geier v. Amercian Honda Motor Co., 529 U.S. 861 (2000), which had addressed a different portion of FMVSS 208 that involved passive restraints, and had found preemption. But unlike in Geier, the regulatory decision to allow auto manufacturers to install either lap belts or lap-and-shoulder belts for rear inner seats was not a “significant regulatory objective.” Moreover, the Department of Transportation, the agency charged with implementing the statute under which FMVSS 208 was promulgated, stated that the regulation did not preempt a state-law tort case of the Williamson type. The Court found the agency’s view persuasive.
Federal preemption issues surface in many cases. The Supreme Court of New Jersey currently has before it cross-petitions for certification in Cornett v. Johnson & Johnson, 414 N.J. Super. 365 (App. Div. 2010), which held that manufacturing defect, failure to warn, and certain warranty claims were not preempted by the Medical Device Amendments to the federal Food, Drug and Cosmetic Act, while other claims were preempted. [Disclosure: I am co-counsel for the plaintiff in Cornett]. Federal preemption issues bear careful observation.