Bruesewitz v. Wyeth LLC
562 U.S. ___ (2011)

Annotate this Case

SYLLABUS
OCTOBER TERM, 2010
BRUESEWITZ V. WYETH LLC


SUPREME COURT OF THE UNITED STATES

BRUESEWITZ et al. v. WYETH LLC, fka WYETH, INC., et al.

certiorari to the united states court of appeals for the third circuit

No. 09–152. Argued October 12, 2010—Decided February 22, 2011

The National Childhood Vaccine Injury Act of 1986 (NCVIA or Act) created a no-fault compensation program to stabilize a vaccine market adversely affected by an increase in vaccine-related tort litigation and to facilitate compensation to claimants who found pursuing legitimate vaccine-inflicted injuries too costly and difficult. The Act provides that a party alleging a vaccine-related injury may file a petition for compensation in the Court of Federal Claims, naming the Health and Human Services Secretary as the respondent; that the court must resolve the case by a specified deadline; and that the claimant can then decide whether to accept the court’s judgment or reject it and seek tort relief from the vaccine manufacturer. Awards are paid out of a fund created by an excise tax on each vaccine dose. As a quid pro quo, manufacturers enjoy significant tort-liability protections. Most importantly, the Act eliminates manufacturer liability for a vaccine’s unavoidable, adverse side effects.

      Hannah Bruesewitz’s parents filed a vaccine-injury petition in the Court of Federal Claims, claiming that Hannah became disabled after receiving a diphtheria, tetanus, and pertussis (DTP) vaccine manufactured by Lederle Laboratories (now owned by respondent Wyeth). After that court denied their claim, they elected to reject the unfavorable judgment and filed suit in Pennsylvania state court, alleging, inter alia, that the defective design of Lederle’s DTP vaccine caused Hannah’s disabilities, and that Lederle was subject to strict liability and liability for negligent design under Pennsylvania common law. Wyeth removed the suit to the Federal District Court. It granted Wyeth summary judgment, holding that the relevant Pennsylvania law was preempted by 42 U. S. C. §300aa–22(b)(1), which provides that “[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, 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.” The Third Circuit affirmed.

Held: The NCVIA preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by a vaccine’s side effects. Pp. 7–19.

   (a) Section 300aa–22(b)(1)’s text suggests that a vaccine’s designis not open to question in a tort action. If a manufacturer could be held liable for failure to use a different design, the “even though” clause would do no work. A vaccine side effect could always have been avoidable by use of a different vaccine not containing the harmful element. The language of the provision thus suggests the design is not subject to question in a tort action. What the statute establishes as a complete defense must be unavoidability (given safe manufacture and warning) with respect to the particular design. This conclusion is supported by the fact that, although products-liability law establishes three grounds for liability—defective manufacture, inadequate directions or warnings, and defective design—the Act mentions only manufacture and warnings. It thus seems that the Act’s failure to mention design-defect liability is “by deliberate choice, not inadvertence.” Barnhart v. Peabody Coal Co., 537 U. S. 149, 168. Pp. 7–8.

   (b) Contrary to petitioners’ argument, there is no reason to believe that §300aa–22(b)(1)’s term “unavoidable” is a term of art incorporating Restatement (Second) of Torts §402A, Comment k, which exempts from strict liability rules “unavoidably unsafe products.” “Unavoidable” is hardly a rarely used word, and cases interpreting comment k attach special significance only to the term “unavoidably unsafe products,” not the word “unavoidable” standing alone. Moreover, reading the phrase “side effects that were unavoidable” to exempt injuries caused by flawed design would require treating “even though” as a coordinating conjunction linking independent ideas when it is a concessive, subordinating conjunction conveying that one clause weakens or qualifies the other. The canon against superfluity does not undermine this Court’s interpretation because petitioners’ competing interpretation has superfluity problems of its own. Pp. 8–12.

   (c) The structure of the NCVIA and of vaccine regulation in general reinforces what §300aa–22(b)(1)’s text suggests. Design defects do not merit a single mention in the Act or in Food and Drug Administration regulations that pervasively regulate the drug manufacturing process. This lack of guidance for design defects, combined with the extensive guidance for the two liability grounds specifically mentioned in the Act, strongly suggests that design defects were not mentioned because they are not a basis for liability. The Act’s mandates lead to the same conclusion. It provides for federal agency improvement of vaccine design and for federally prescribed compensation, which are other means for achieving the two beneficial effects of design-defect torts—prompting the development of improved designs, and providing compensation for inflicted injuries. The Act’s structural quid pro quo also leads to the same conclusion. The vaccine manufacturers fund an informal, efficient compensation program for vaccine injuries in exchange for avoiding costly tort litigation and the occasional disproportionate jury verdict. Taxing their product to fund the compensation program, while leaving their liability for design defect virtually unaltered, would hardly coax them back into the market. Pp. 13–16.

561 F. 3d 233, affirmed.

   Scalia, J., delivered the opinion of the Court, in which Roberts, C. J., and Kennedy, Thomas, Breyer, and Alito, JJ., joined. Breyer, J., filed a concurring opinion. Sotomayor, J., filed a dissenting opinion, in which Ginsburg, J., joined. Kagan, J., took no part in the consideration or decision of the case.

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