## Facts

- Michelle Graham, an infant, allegedly suffered severe, irreversible brain damage after receiving a Wyeth-manufactured DPT vaccine.
- Before vaccination, Michelle’s mother reviewed written materials and signed a consent form; she claimed a nurse minimized side-effect risks and pressured consent by invoking possible state intervention.
- After vaccination, Michelle developed encephalopathy; plaintiffs attributed the injury to the vaccine.
- Plaintiffs alleged Wyeth could have made the vaccine safer or reduced risks but declined due to cost and failed to provide adequate warnings of severe adverse reactions.
- Claims included strict liability and negligence (design defect and failure to warn), breach of implied warranties, intentional misrepresentation, and punitive damages.

## Issues

1. Whether federal vaccine regulation and related federal statutes preempt state-law claims for design defect, failure to warn, implied warranty, and misrepresentation involving an FDA-approved DPT vaccine.
2. Whether, under Kansas law and Restatement (Second) of Torts § 402A comment k, the DPT vaccine must be treated as an “unavoidably unsafe” product with adequate warnings as a matter of law, barring plaintiffs’ claims at summary judgment.
3. Which theories, if any, fail as a matter of law on summary judgment.

## Decision

- The court held plaintiffs’ state-law claims were not preempted by federal law and FDA regulation.
- The court declined to rule, on the summary-judgment record, that the DPT vaccine was “unavoidably unsafe” as a matter of law or that Wyeth’s warnings were adequate as a matter of law.
- The court denied summary judgment on plaintiffs’ design-defect theories (strict liability and negligence), negligent failure to warn, implied-warranty claims, intentional misrepresentation, and punitive damages.
- The court granted summary judgment only on the strict-liability failure-to-warn theory.

## Legal Principles

- Federal regulation and FDA approval generally establish minimum requirements and do not, without clear congressional intent, displace traditional state tort remedies for vaccine-related injuries.
- Kansas application of comment k is product- and record-specific; whether a prescription product is “unavoidably unsafe” may present fact questions, including feasibility of safer alternatives or risk-reducing measures.
- Warning adequacy commonly depends on disputed facts about content and communication in the circumstances, making it unsuitable for resolution as a matter of law where the record is contested.
- Under Kansas law in this setting, strict-liability failure-to-warn may be barred while negligence-based warning claims can remain viable.

## Conclusion

The court rejected Wyeth’s preemption and categorical comment k immunity arguments at summary judgment, allowing most claims—design defect, negligent failure to warn, implied warranty, misrepresentation, and punitive damages—to proceed to trial, while dismissing only the strict-liability failure-to-warn claim.


Graham ex rel. Graham v. Wyeth Lab’ys, 666 F. Supp. 1483 (D. Kan. 1987)