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Vaccine law pre-empts design-defect claims: Supreme Court


WASHINGTON—The National Childhood Vaccine Injury Act of 1986 pre-empts all design-defect claims against vaccine makers by claimants seeking compensation for injury or death caused by any side effects, the U.S. Supreme Court ruled Tuesday.

The case—Russell Bruesewitz and Robalee Bruesewitz vs. Wyeth Inc. et al.—involved Hannah Bruesewitz, a 6-month-old child who suffered permanent developmental damage after receiving Wyeth’s Tri-Immunol, a combined vaccine for diphtheria, pertussis and tetanus, in 1992.

The federal vaccine law was designed to encourage vaccine manufacturers to remain in the market by limiting their liability while creating a federal vaccine injury compensation program. The law holds that 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 Oct. 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and accompanied by proper directions and warnings.

The Bruesewitzes argued that the law does not preclude all vaccine design-defect claims if the side effects were avoidable, which they argued was the case with their daughter, and that Wyeth could have made a safer vaccine.

They first sought compensation from a special vaccine court, which rejected their claim. Then they sued in Pennsylvania state court, from which Wyeth had the case moved to federal court. The federal court and a three-judge panel of the 3rd U.S. Circuit Court of Appeals later upheld Wyeth’s claim of pre-emption.

In a 6-2 ruling Tuesday in which Associate Justice Elena Kagan did not participate, the Supreme Court upheld the lower courts. Writing for the court, Associate Justice Antonin Scalia said the lack of a single mention of design defects in the National Childhood Vaccine Injury Act or in Food and Drug Administration rules regulating drug manufacturing “strongly suggests that design defects were not mentioned because they are not a basis for liability.”

He further noted that manufacturers fund the compensation program “in exchange for avoiding costly tort litigation” and the “occasional disproportionate” jury award. “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,” Justice Scalia wrote.

Associate Justices Sonia Sotomayor and Ruth Bader Ginsburg dissented, saying the ruling leaves a “regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products.”

The decision is available at