February 24, 2011


Supreme Court Rules That Federal Vaccine Law Preempts All Design-Defect Claims

By David Gossett and Brian Wong, Mayer Brown

The National Childhood Vaccine Injury Act of 1986 ("Vaccine Act"), 42 U.S.C. §§ 300aa-1 et seq., expressly preempts state-law claims against manufacturers of certain covered vaccines if the injury or death giving rise to such a claim "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).

Earlier this week, in Bruesewitz v. Wyeth, No. 09-152, the Supreme Court held that the Vaccine Act categorically preempts all design-defect claims against such manufacturers, basing that decision on a careful reading of the language of the statute, as confirmed by an understanding of the reasons why Congress created the Vaccine Act in the first place - i.e., ensuring the continued availability of vaccines and stabilizing the vaccine market by limiting vaccine-related tort litigation, while at the same time facilitating compensation to legitimate claimants by channeling their claims into a no-fault, administrative compensation system funded by vaccine manufacturers. The National Chamber Litigation Center (NCLC) filed an amicusbrief in support of Wyeth in the case, drafted by David Gossett and Brian Wong of Mayer Brown LLP.

Lower courts had been divided over the preemptive scope of the Vaccine Act. In the decision that was affirmed by the Supreme Court, the Third Circuit held that the Vaccine Act preempts all design-defect claims, including both those sounding in negligence and those sounding in strict-liability. The Georgia Supreme Court, by contrast, previously held that a design-defect claim is not preempted unless the manufacturer demonstrates, on case-by-case basis, that there was no safer design that could have avoided the injury giving rise to the claim.

The Supreme Court's Decision

Writing for the Bruesewitzmajority, Justice Scalia explained that the "even though" clause in the Vaccine Act's preemption provision enumerates the steps that a vaccine manufacturer must take for an injury or death to be considered "unavoidable" for purposes of the statute. In other words, if the vaccine was "properly prepared and was accompanied by proper directions and warning," any side effects - including those resulting from alleged design defects - are deemed to have been "unavoidable." State-law claims premised on such side effects are, accordingly, barred by the Vaccine Act.

The Court rejected the dissent's contention that the word "unavoidable" in the preemption provision was a term of art that incorporated Comment k to Restatement (Second) of Torts § 402A. Generally speaking, the Restatement's approach to products liability holds a manufacturer strictly liable for harms caused by unreasonably dangerous products. Comment k exempts from this strict-liability rule products that are "unavoidably unsafe." Petitioners had argued (and the dissent agreed) that, at the time the Vaccine Act was enacted, courts understood Comment k as requiring a case-by-case showing by the manufacturer that the product in question was not capable of feasibly being made safer. The Court disagreed, explaining that there was no reason to believe that the Vaccine Act's use of the word "unavoidable" (as distinguished from "unavoidably unsafe") was meant to invoke this analysis: "Unavoidable," the Court observed, is hardly a rarely used word. And, in any event, Comment k had not been uniformly interpreted-some courts thought it required a case-specific showing that a product was "unavoidably unsafe," while others thought it categorically exempted certain classes of products from strict liability.

The Court found additional support for a broad reading of the preemption provision in the structure and purpose of the Vaccine Act. The Vaccine Act and its implementing regulations specify in great detail how covered vaccines must be manufactured, and a vaccine's license contains the exact language of the warnings and directions that must accompany the vaccine. Any deviation from these detailed federal standards could take the manufacturer outside the Vaccine Act's preemption provision. By contrast, the Vaccine Act provided no guidance as to how the safety or effectiveness of a vaccine was to be evaluated. The Court reasoned that this lack of "guidance for design defects combined with the extensive guidance for the two grounds of liability specifically mentioned in the Act strongly suggests that design defects were not mentioned because they are not a basis for liability." Slip op. 14. Moreover, other provisions of the Vaccine Act established a "structural quid pro quo" that would be undermined by allowing design-defect claims to proceed. In exchange for funding, via an excise tax, an informal, administrative compensation scheme for vaccine injuries-which allows claimants to recover without proof of negligence or, indeed, the existence of any defect-manufacturers received significant protection from state-law tort liability. It would be anomalous for design-defect claims to be left out of this bargain.Finally, the Court rejected the argument that the Vaccine Act's legislative history demonstrated that Congress intended to require vaccine manufacturers to show, on a case-by-case basis, that no safer, feasible alternative design existed. The Committee Report that accompanied the preemption provision itself supported a broad reading of the preemption provision. And the Committee Report that accompanied the later legislation that created the excise tax funding the compensation scheme was "post-enactment" legislative history, and therefore not a legitimate tool of statutory interpretation.

In a concurring opinion, Justice Breyer joined the Court's judgment and opinion in full. In Justice Breyer's view, however, the textual question was a close one. His concurrence explained why the "legislative history, statutory purpose, and the views of the federal administrative agency, supported by expert medical opinion," reinforced the Court's reading of the Vaccine Act's preemption provision. Slip op. 1 (Breyer, J., concurring). Justice Breyer observed that the Committee Report characterized that provision as setting forth the principleof Comment k-not the details of how Comment k had been elaborated by various state courts. That principle (as the Chamber's amicusbrief explained) is that vaccine manufacturers, like manufacturers of other unavoidably unsafe products, should not be held liable for design-defect-related injuries.

The dissenting opinion was written by Justice Sotomayor and joined by Justice Ginsburg. Justice Kagan did not participate in the case.

One interesting thing to note about the majority opinion and Justice Breyer's concurring opinion is that neither mentions the so-called "presumption against preemption," to which the dissent pointed to support its argument. The Chamber's amicusbrief argued at some length that the presumption should have no bearing on express-preemption cases, so the lack of any reference to it in the majority's opinion was quite gratifying.

The Practical Effect

All in all, this case is of great interest and importance to vaccine makers, as well as everyone who has been following the ongoing debate about whether certain childhood vaccines cause autism. (The decision likely will preclude those claims going forward, although the plaintiffs' bar may try to evade its effect by proceeding on different legal theories.) That said, the Bruesewitzdecision is unlikely to have much immediate impact on other areas of preemption law, given the distinctive textual and structural features of the Vaccine Act's preemption provision. At the very least, though, it does demonstrate that the Supreme Court is willing to give effect to the plain meaning of express-preemption provisions when Congress includes them in statutes.

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David Gossett and Brian Wong, both of Mayer Brown, served as co-counsel with NCLC on the Chamber's amicusbrief in this case. For further information, please contact David at (202) 263-3384 or Brian at (202) 263-3734.

The National Chamber Litigation Center is the leading voice of business in the courts. For more information about this and other NCLC litigation, please contact Sheldon Gilbert at (202) 463-5337.