Bruesewitz v. Wyeth LLC

CourtUnited States Supreme Court
Citation131 S.Ct. 1068,179 L.Ed.2d 1,562 U.S. 223
Docket NumberNo. 09–152.,09–152.
Parties Russell BRUESEWITZ, et al., Petitioners, v. WYETH LLC, fka Wyeth, Inc., fka Wyeth Laboratories, et al.
Decision Date22 February 2011

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, Houston, Texas, Collyn A. Peddie, Houston, Texas, David C. Frederick, Derek T. Ho, Brendan J. Crimmins, Janie N. Kucera, Kellogg, Huber, Hansen, Todd, Evans & Figel, P.L.L.C., Washington, D.C., Petitioners.

Daniel J. Thomasch, Richard W. Mark, E. Joshua Rosenkranz, Lauren J. Elliot, John L. Ewald, Orrick, Herrington & Sutcliffe LLP, New York, NY, Kathleen M. Sullivan, Faith E. Gay, Sanford I. Weisburst, William B. Adams, Quinn Emanuel Urquhart & Sullivan, LLP, New York, NY, for Respondent.

Justice SCALIA delivered the opinion of the Court.

We consider whether a preemption provision enacted in the National Childhood Vaccine Injury Act of 1986 (NCVIA)1 bars state-law design-defect claims against vaccine manufacturers.

I
A

For the last 66 years, vaccines have been subject to the same federal premarket 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 product-liability suits were filed against DTP manufacturers, 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

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 person injured by a vaccine, or his legal guardian, may file a petition for compensation in the United States Court of Federal Claims, naming the Secretary of Health and Human Services as the respondent.13 A special master then makes an informal adjudication of the petition within (except for two limited exceptions) 240 days.14 The Court of Federal Claims must review objections to the special master's decision and enter final judgment under a similarly tight statutory deadline.15 AT THAT POINT, A CLaimant has two options: to accept the court's judgment and forgo a traditional tort suit for damages, or to reject the judgment and seek tort relief from the vaccine manufacturer.16

Fast, informal adjudication is made possible by the Act's Vaccine Injury Table, which lists the vaccines covered under the Act; describes each vaccine's compensable, adverse side effects; and indicates how soon after vaccination

those side effects should first manifest themselves.17 Claimants who show that a listed injury first manifested itself at the appropriate time are prima facie entitled to compensation. 18

No showing of causation is necessary; the Secretary bears the burden of disproving causation.19 A claimant may also recover for unlisted side effects, and for listed side effects that occur at times other than those specified in the Table, but for those the claimant must prove causation.20 Unlike in tort suits, claimants under the Act are not required to show that the administered vaccine was defectively manufactured, labeled, or designed.

Successful claimants receive compensation for medical, rehabilitation, counseling, special education, and vocational training expenses; diminished earning capacity; pain and suffering; and $250,000 for vaccine-related deaths.21 Attorney's fees are provided, not only for successful cases, but even for unsuccessful claims that are not frivolous.22 These awards are paid out of a fund created by an excise tax on each vaccine dose.23

The quid pro quo for this, designed to stabilize the vaccine market, was the provision of significant tort-liability protections for vaccine manufacturers. The Act requires claimants to seek relief through the compensation program before filing suit for more than $1,000.24 Manufacturers are generally immunized from liability for failure to warn if they have complied with all regulatory requirements (including but not limited to warning requirements) and have given the warning either to the claimant or the claimant's physician.25 They are immunized from liability for punitive damages absent failure to comply with regulatory requirements, "fraud," "intentional and wrongful withholding of information," or other "criminal or illegal activity."26 And most relevant to the present case, the Act expressly eliminates liability for a vaccine's unavoidable, adverse side effects:

"No 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."27
B

The vaccine at issue here is a DTP vaccine

manufactured by Lederle Laboratories. It first received federal approval in 1948 and received supplemental approvals in 1953 and 1970. Respondent Wyeth purchased Lederle in 1994 and stopped manufacturing the vaccine in 1998.

Hannah Bruesewitz was born on October 20, 1991. Her pediatrician administered doses of the DTP vaccine

according to the Center for Disease Control's recommended childhood immunization schedule.

Within 24 hours of her April 1992 vaccination

, Hannah started to experience seizures.28 She suffered over 100 seizures during the next month, and her doctors eventually diagnosed her with "residual seizure disorder" and "developmental delay."29 Hannah, now a teenager, is still diagnosed with both conditions.

In April 1995, Hannah's parents, Russell and Robalee Bruesewitz, filed a vaccine injury petition in the United States Court of Federal Claims, alleging that Hannah suffered from on-Table residual seizure disorder and encephalopathy

injuries.30 A Special Master denied their claims on various grounds, though they were awarded $126,800 in attorney's fees and costs. The Bruesewitzes elected to reject the unfavorable judgment, and in October 2005 filed this lawsuit in Pennsylvania state court. Their complaint alleged (as relevant here) that 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.31

Wyeth removed the suit to the United States District Court for the Eastern District of Pennsylvania, which granted Wyeth summary judgment on the strict-liability and negligence design-defect claims, holding that the Pennsylvania law providing those causes of action was preempted by 42 U.S.C. § 300aa–22(b)(1).32 The United States Court of Appeals for the Third Circuit affirmed.33 We granted certiorari. 559 U.S. ––––, 130 S.Ct. 1734, 176 L.Ed.2d 211 (2010).

II
A

We set forth again the statutory text at issue:

"No 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."34

The "even though" clause clarifies the word that precedes it. It delineates the preventative measures that a vaccine manufacturer must have taken for a side-effect to be considered "unavoidable" under the statute. Provided that there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable. State-law design-defect claims are therefore preempted.

If 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. The language of the provision thus suggests that the design of the vaccine is a given, not subject to question in the tort action. What the statute establishes as a complete defense must be unavoidability (given safe...

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