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Keywords

liabilityappeal
liabilityappealregulationproduct liability

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Hurley v. Lederle Laboratories Div. of American Cyanamid Co., 863 F.2d 1173

Facts

James Hurley III was vaccinated with a DPT vaccine manufactured by Lederle Laboratories when he was less than a year old. Shortly after the vaccination, he suffered severe and irreversible neurological damage. Although the vaccine package included a warning about potential adverse reactions, this warning was not communicated to the parents. The doctor who administered the vaccine testified that he found the warning adequate, but the parents argued that the vaccine was unreasonably dangerous due to the availability of safer alternatives in other countries.

James Hurley III was less than a year old when he was vaccinated with a DPT vaccine, which includes three separate components to immunize against diptheria, pertussis, and tetanus.

Issue

Did federal law preempt state law products liability claims against the vaccine manufacturer, and was the manufacturer's warning adequate under the learned intermediary doctrine?

The Court of Appeals, E. Grady Jolly, Circuit Judge, held that: (1) federal law did not implicitly preempt state law product liability action against vaccine manufacturer; (2) 'mass immunization' exception to 'learned intermediary' doctrine was inapplicable and manufacturer satisfied duty to warn by warning physician; and (3) fact issue existed as to whether manufacturer withheld material information from FDA so as to render FDA–approved warning inadequate.

Rule

Federal law does not implicitly preempt state law products liability claims, and the learned intermediary doctrine applies only when a physician makes an individualized medical judgment regarding the administration of a vaccine.

Although, as we shall later see, there are some instances in which state law may conflict with individual federal laws or regulations, Lederle's arguments and the district court's holding are so broadly phrased as to preempt all of state products liability law for the manufacture and distribution of the pertussis vaccine.

Analysis

The court found that the district court's ruling on preemption was flawed, as the majority of district courts had ruled against preemption in similar cases. The court also determined that the learned intermediary doctrine did not apply in this case because the vaccination was administered in a routine manner without individualized medical judgment, thus the manufacturer had a duty to ensure that the warning reached the parents.

Although the district court arrived at its holding after careful and thoughtful consideration, we must conclude that its holding is flawed.

Conclusion

The Court of Appeals reversed the district court's decision and remanded the case for further proceedings, holding that federal law does not preempt state products liability law governing vaccinations.

In sum, it is possible to construct sound policy arguments in favor of preemption in this case, but there is virtually no indication in the relevant law that Congress or the FDA explicitly or implicitly accepted them.

Who won?

The Hurleys prevailed in the appeal because the court found that federal law did not preempt their state law claims and that there were unresolved factual issues regarding the adequacy of the warning.

Since we disagree with the district court that federal law preempts the state products liability law, and since our examination of the record reveals factual questions remaining on the other issues, we reverse and remand.

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