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Can't Sue Drug Companies for Vaccine Defects Rules Supreme Court

By Stephanie Rabiner, Esq. on February 23, 2011 | Last updated on March 21, 2019

On a 6-2 vote, the Supreme Court has issued an opinion ruling that vaccine makers cannot be sued in state courts for vaccine defects that arise out of the product's design. The case, Bruesewitz v. Wyeth, stems from a series of DPT shots given to Hannah Bruesewitz when she was an infant in 1992.

After receiving the third shot in the series, Hannah began to have seizures, reports CNN. The family blamed Wyeth for the child's disorder, alleging that the manufacturer had a better, less dangerous vaccine that it failed to promote. The "vaccine court" rejected the claim that the vaccine was tied to Hannah's injuries. The Bruesewitzes then sued Wyeth in state court alleging design defects.

What many people don't know is that the "vaccine court" comes from the National Childhood Vaccine Injury Act of 1986. The Act was a response to vaccine shortages caused by frequent tort lawsuits against vaccine manufacturers. It provides immunity to vaccine manufacturers in exchange for a small excise tax on each dose. Persons injured by vaccines file claims in the Court of Federal Claims, and injuries found linked to vaccines are compensated from a fund.

The issue presented in Bruesewitz v. Wyeth was whether the Act preempted state law claims against manufacturers for vaccine defects related to design. In other words, in addition to or instead of the vaccine court, can vaccine manufacturers be sued in state court for design defects?

In deciding that there is no design defect liability outside of the vaccine court, the Supreme Court employed the doctrine of preemption. Preemption basically means that federal law supersedes state law when the two conflict. The Act does not specifically address the issue of vaccine defects in design, or speak to state law claims. Therefore, the Court had to employ a bit of interpretation.

The Act specifically states that vaccine manufacturers are not liable for injuries and death that "result from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."

The Court pointed to the "even though" clause, basically saying that it lists the measures a manufacturer must take for injury to be considered unavoidable, thus limiting liability. So, as long as a vaccine maker manufactured the drug properly and included proper directions and warnings, it is not liable for anything--included vaccine defects related to design.

What does this mean for people who are injured by vaccines? It's very likely that, unless a victim can prove that a vaccine maker didn't manufacture the product correctly, or didn't include proper directions or warnings, he's stuck in the vaccine court and any limitations it has imposed on recovery.

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