562 U.S. 223 (2011), 09-152, Bruesewitz v. Wyeth LLC
|Citation:||562 U.S. 223, 131 S.Ct. 1068, 179 L.Ed.2d 1, 79 U.S.L.W. 4067|
|Opinion Judge:||SCALIA, JUSTICE|
|Party Name:||Russell BRUESEWITZ, et al., Petitioners, v. WYETH LLC, fka Wyeth, Inc., fka Wyeth Laboratories, et al.|
|Attorney:||David C. Frederick, Washington, DC, for Petitioners. Kathleen M. Sullivan, New York, NY, for Respondents. Benjamin J. Horwich, for United States as amicus curiae, by special leave of the Court, supporting the Respondents. John Eddie Williams, John T. Boundas, Williams Kherkher, Hart Boundas, LLP,...|
|Judge Panel:||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 considera|
|Case Date:||February 22, 2011|
|Court:||United States Supreme Court|
Argued October 12, 2010
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT No. 09152.
[179 L.Ed.2d 5] [131 S.Ct. 1070] Syllabus [*]
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. §300aa22(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.
The NCVIA pre-empts all design-defect claims against vaccine manufacturers [131 S.Ct. 1071] brought by plaintiffs seeking compensation for injury or death caused by a vaccine's side effects. Pp. 231-243, 179 L.Ed.2d, at 10-17.
(a) Section 300aa22(b)(1)'s text suggests that a vaccine's design is 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 [179 L.Ed.2d 6] is "by deliberate choice, not inadvertence." Barnhart v. Peabody Coal Co., 537 U.S. 149, 168, 123 S.Ct. 748, 154 L.Ed.2d 653. P. 1076, 179 L.Ed.2d, at 10-11.
(b) Contrary to petitioners' argument, there is no reason to believe that §300aa22(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. 1076-1078, 179 L.Ed.2d, at 11-13.
(c) The structure of the NCVIA and of vaccine regulation in general reinforces what §300aa22(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. 1078 -1080, 179 L.Ed.2d, at 13-15.
561 F.3d 233, affirmed.
We consider whether a pre-emption provision enacted in the National Childhood Vaccine Injury Act of 1986 (NCVIA)1 bars state-law design-defect [179 L.Ed.2d 7] claims against vaccine manufacturers
For the last 66 years, vaccines have been subject to the same federal pre-market approval process as prescription drugs, and compensation for vaccine-related injuries has been left largely to the States.2 Under that regime, the elimination of communicable diseases through vaccination became "one of the greatest achievements" of public health in the 20th century.3 But in the 1970's and 1980's vaccines became, one might say, victims of their own success. They had been so effective in preventing infectious diseases that the public became much less alarmed at the threat of those diseases, 4 and much more concerned with the risk of injury from the vaccines themselves.5
Much of the concern centered around vaccines against diphtheria, tetanus, and pertussis (DTP), which were blamed for children's disabilities and developmental delays. This led to a massive increase in vaccine-related tort litigation. Whereas between 1978 and 1981 only nine products-liability suits were filed against DTP manufacturers[131 S.Ct. 1073], by the mid-1980's the suits numbered more than 200 each year.6 This destabilized the DTP vaccine market, causing two of the three domestic manufacturers to withdraw; and the remaining manufacturer, Lederle Laboratories, estimated that its potential tort liability exceeded its annual sales by a factor of 200.7 Vaccine shortages arose when Lederle had production problems in 1984.8
Despite the large number of suits, there were many complaints that obtaining compensation for legitimate vaccine-inflicted injuries was too costly and difficult.9 A significant number of parents were already declining vaccination for their children, 10 and concerns about compensation threatened to depress vaccination rates even further.11 This was a source of concern to public health officials, since vaccines are effective in preventing outbreaks of disease only if a large percentage of the population is vaccinated.12
[179 L.Ed.2d 8] To stabilize the vaccine market and facilitate compensation, Congress enacted the NCVIA in 1986. The Act establishes a no-fault compensation program "designed to work faster and with greater ease than the civil tort system." Shalala v. Whitecotton, 514 U.S. 268, 269, 115 S.Ct. 1477, 131 L.Ed.2d 374 (1995). A...
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