On February 22, 2011, the Supreme Court delivered a major win for pharmaceutical manufacturers in Bruesewitz v. Wyeth, holding that Congress intended the 1986 National Childhood Vaccine Injury Act (NCVIA) to preempt all vaccine-related tort liability when Congress wrote, “[n]o vaccine manufacturer shall be liable…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.” In a 6-2 decision (Kagan did not participate) the High Court held that Vaccine Court is the exclusive remedy for all such claims.
To recover damages in Vaccine Court, a claimant needs to show prima-facie causation pursuant to the NCVIA’s Vaccine Injury Table, which lists the vaccines covered, describes qualified side effects; and indicates how soon after vaccination those side effects should first manifest themselves. Unlike strict liability and negligence claims, claimants under the NCVIA are not required to show that the vaccine was defectively manufactured, labeled or designed. Plaintiff Bruesewitz, however, chose not to proceed in Vaccine Court and instead directly sued Wyeth alleging the vaccine was defectively designed because the company failed to produce a differently designed vaccine that would have prevented the resulting side effects.
Plaintiff Bruesewitz argued that Congress did not intend the NCVIA to preempt all state law claims because the Act does not include language for “design defects.” In addition, she argued the word “unavoidable” means “as safe as possible.” The Supreme Court disagreed and held that the safest design is not always the best design — a balance must be achieved between safety and efficacy. It stated “[i]f a manufacturer could be held liable for failure to use a different design, the word “unavoidable” would do no work. A side effect of a vaccine could always have been avoidable by use of a differently designed vaccine not containing the harmful element.”
This case has major impact on how all vaccine injuries are pursued and the critical role the Vaccine Court has in resolving claims. Today’s ruling also ensures that pharmaceutical manufacturers can continue to provide inexpensive vaccines to prevent epidemic and widespread disease, while ensuring a generous compensation scheme for those who are injured.
This latest holding, while significant, probably does not likely signal the beginning of a trend in favor of federal preemption over state law tort claims. It has been only two years since Wyeth v. Levine, when the Supreme Court decided 6-3 to invalidate the language in the preamble to a 2006 FDA regulation stating that FDA’s approval of a drug label preempts contrary failure-to-warn state law claims, because the preamble did not have the force of law. Here, the issue is the interpretation of the language of an express preemption statute.
The case is Bruesewitz et al. v. Wyeth et al., 562 U. S. ____, No. 09-152, Slip Op. (U.S. February 22, 2011).