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Bruesewitz v. Wyeth, Vaccines and NCVIA

posted on Tue, Mar 8 2011 10:29 am by Erin Fuse Brown and Jalayne Arias

On February 22, 2011 the United States Supreme Court decided Bruesewitz v. Wyeth regarding vaccine manufacturers’ liability for design-defects. At issue was whether state law claims for design defects are preempted under the National Childhood Vaccine Injury Act (NCVIA) of 1986. Although the Court’s decision that NCVIA preempts design-defects claims is lauded as a win for public health, others criticize the decision as creating a dangerous regulatory vacuum for vaccine improvement and safety.

In passing NCVIA, Congress created a no-fault program to compensate individuals who experience adverse reactions to vaccinations and to protect the vaccine market from certain types of liability to ensure a sufficient production of vaccines. NCVIA allows claimants injured by the administration of a vaccine to petition a vaccine court for an award paid from a fund created by excise taxes on vaccines. Unless preempted by NCVIA, a claimant could accept the vaccine court’s judgment or file a state-based claim against the manufacturer.

Hannah Bruesewitz suffered seizures and permanent disabilities following the administration of the DTP vaccination when she was 6 months old. Hannah’s parents brought a claim before the vaccine court on her behalf, but they were denied an award. The Bruesewitzs rejected the vaccine court’s ruling and filed a state claim alleging, among other things, that the vaccine manufactured by Lederle Laboratories (later purchased by Wyeth) had a defective design that caused their daughter’s disabilities.

In a decisive 6-2 vote, with Justice Kagan sitting out, the Supreme Court ruled that the NCVIA preemptively bars all state law design-defect claims against vaccine manufacturers. Justice Scalia, writing for the majority, relied on a textual analysis of NCVIA’s provision that no vaccine manufacturer is liable for a vaccine-related injury “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 Court noted the underlying policy concern of NCVIA to stabilize the market by enticing manufacturers to remain in the vaccine business and avert the vaccine shortages seen in the 1980s due to the threat of tort liability. The Court concluded that allowing design-defect tort claims, the most speculative and difficult type of products liability claim to litigate, would “hardly coax manufacturers back into the market.”

In her dissent, Justice Sotomayor expressed concern that the Court’s decision creates a significant regulatory vacuum—the Food and Drug Administration’s (FDA) approval process does not require vaccines to be optimally designed or continuously improved, and traditionally state tort liability for design-defects has provided such an incentive for manufacturers.

The Court’s decision is hailed by some public health commentators because it prevents the specter of a vaccine supply crisis which led to the passage of NCVIA. The Court’s position was urged by the federal Department of Health and Human Services, the American Public Health Association, the American Academy of Pediatrics and many other professional medical associations. Nevertheless, like the dissent, a minority of commentators are concerned that vaccine manufacturers will lack incentives to improve their vaccine designs once approved by FDA. Both sides, and the Court, seem to recognize that the compensation scheme created by NCVIA is a significant and necessary public health achievement. In Bruesewtiz, the Court affirms the continuation of this program in a legal environment free from extensive liability for manufacturers.

This information was developed by Erin Fuse Brown and Jalayne Arias, deputy directors of the Network for Public Health Law – Western Region, with assistance from Andrew Sorensen, legal researcher.

The Network for Public Health Law provides information and technical assistance on issues related to public health. The legal information and assistance provided in this document does not constitute legal advice or legal representation. For legal advice, readers should consult a lawyer in their state.
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