Federal Preemption Question Comes Before Supreme Court Next Week

Next Tuesday, October 12, the Supreme Court will hear oral arguments in Bruesewitz v. Wyeth, a case that raises the issue of federal preemption in the context of manufacturer liability for defectively designed products.  The arguments turn on whether the limited immunity from liability for vaccine manufacturers under the National Childhood Vaccine Injury Act of 1986 effectively preempts all vaccine design defect claims against manufacturers.  Section 22(b)1) of the Act states that claims based on design defects will not be entertained “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 warning.” 42 U.S.C. § 300aa-22(b)(1). Under the Act, victims of such injuries are compensated by the U.S. government but have no recourse against the makers of the vaccines.

Petitioners argue that when injury from vaccines is inevitable, as they claim the injuries were in this case, the Act should not preempt liability.  Petitioners are parents whose six month old daughter suffered permanent developmental impairment as a direct result of multiple seizures that were caused by the administration of a diphtheria-tetanus-pertussis vaccine manufactured by the Respondents.  They state that the dose of vaccine their daughter received came from a lot that was associated with 31 adverse reactions, including one death, before it was administered to their daughter, and that information about problems with the lot were deliberately obscured by the company.  Thus, Petitioners claim, their daughter’s injury was avoidable and so falls outside of the preemption in 22(b)(1) of the Act.  They argue that the Congressional record as well as the clear language of the statute confirm that 22(b)(1) does not exempt vaccine manufacturers for liability from foreseeable injury that could have been prevented.  They further assert that as a policy matter, holding manufacturers responsible for obvious and avoidable design defects promotes the public interests of health, safety and fairness.

Respondents meanwhile argue that the Act was enacted to preempt precisely the sort of litigation now before the court.  The only carve-outs for would-be litigators, they argue, are improper preparation and failure to provide proper directions and warnings.  They, too, cite legislative history- in particular, a 1986 House Energy Committee report stating that if claimants cannot tie their claim to one of those two carve-outs, they “should pursue recompense in the compensation system, not the tort system.”  Respondents also assert that the administrative compensation scheme provided under the act is ample to serve the policy interest of fairness, and that to re-open the doors to design-defect litigation against the manufacturers of vaccines would likely have a chilling effect on research, development and production, possibly resulting in eventual vaccine shortages.

Lively public debate on the safety and efficacy of vaccines is nothing new, but the added federal preemption question in this case makes it particularly noteworthy.  Several high-profile Amici have also added their voice to the briefing including, among others, the National Vaccine Information Center, Public Citizen, Kenneth Starr and Erwin Chemerinsky for the Petitioners and the United States Government, the American Academy of Pediatrics and GlaxoSmithKline LLC for the Respondents.  We will follow up here when the Court announces its decision later in the term.

Briefing can be found here http://www.scotusblog.com/case-files/cases/bruesewitz-v-wyeth/