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Bruesewitz v. Wyeth LLC

Supreme Court of the United States

October 12, 2010, Argued; February 22, 2011, Decided

No. 09-152

Opinion

 [*226]  Justice Scalia delivered the opinion of the Court.

We consider whether a pre-emption provision enacted in the National Childhood Vaccine Injury Act of 1986 (NCVIA)1 bars state-law design-defect [***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

 [*227]  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, [**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

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562 U.S. 223 *; 131 S. Ct. 1068 **; 179 L. Ed. 2d 1 ***; 2011 U.S. LEXIS 1085 ****; 79 U.S.L.W. 4067; CCH Prod. Liab. Rep. P18,580; 22 Fla. L. Weekly Fed. S 790

RUSSELL BRUESEWITZ, et al., Petitioners v. WYETH LLC, fka WYETH, INC., fka WYETH LABORATORIES, et al.

Prior History:  [****1] ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT.

Bruesewitz v. Wyeth Inc., 561 F.3d 233, 2009 U.S. App. LEXIS 6410 (3d Cir. Pa., 2009)

Disposition: Affirmed.

CORE TERMS

vaccine, manufacturers, unavoidable, side effect, design defect, warnings, labeling, legislative history, compensation program, childhood, regulation, Disease, unsafe product, pre-empt, properly prepared, accompanied, pre-emption, claimants, Immunizations, injuries, damages, Labs, petitioners', eliminated, exemption, proper direction, civil action, design-defect, products, defects

Public Health & Welfare Law, Healthcare, Public Health Security, Communicable Diseases, Governments, Legislation, Interpretation