## Facts

- Carolyn Sue Williams took Tegretol (carbamazepine), a prescription drug manufactured by Ciba-Geigy Corporation, as prescribed by her physician.
- Williams developed Stevens–Johnson syndrome, a serious dermatological reaction alleged to be associated with Tegretol.
- Williams sued under Louisiana products-liability and negligence theories, alleging (among other claims) inadequate warnings and that Tegretol was “unreasonably dangerous per se.”
- Ciba-Geigy moved for summary judgment, relying on physician-directed warnings (package insert and Physicians’ Desk Reference) and the drug’s therapeutic utility and FDA approval.
- A magistrate judge recommended summary judgment for Ciba-Geigy on warning adequacy but recommended trial on the “unreasonably dangerous per se” theory; the district judge conducted an independent review.

## Issues

1. Whether Rule 8 barred Williams from asserting an “unreasonably dangerous per se” theory at summary judgment when that label was not expressly used in the complaint.
2. Whether Ciba-Geigy’s warnings to prescribing physicians about Stevens–Johnson syndrome were adequate under Louisiana’s learned intermediary doctrine.
3. Whether an FDA-approved prescription drug, marketed with adequate physician warnings, could be found “unreasonably dangerous per se” on this record.

## Decision

- The court allowed Williams to pursue the “unreasonably dangerous per se” theory despite the complaint’s lack of that specific label, finding the pleadings sufficient to give notice under Rule 8.
- The court held Ciba-Geigy’s warnings to prescribing physicians were adequate as a matter of law and granted summary judgment on all warning-based liability theories.
- The court rejected the magistrate judge’s recommendation on the per se defect theory and held Tegretol was not unreasonably dangerous per se on the summary-judgment record.
- Summary judgment was granted in full for Ciba-Geigy.

## Legal Principles

- Under Rule 8, general allegations that a product is “unreasonably dangerous” may be construed to include recognized subspecies of products-liability theories where the defendant has fair notice.
- Under Louisiana’s learned intermediary doctrine, a prescription drug manufacturer generally satisfies its duty to warn by adequately warning prescribing physicians through professional channels (e.g., package inserts and the PDR).
- A known serious adverse reaction, specifically disclosed in legally adequate physician warnings, does not by itself support a finding that an FDA-approved prescription drug is “unreasonably dangerous per se.”
- To defeat summary judgment on a per se risk–utility theory for a prescription drug, a plaintiff must produce evidence that the drug’s risks so outweigh its therapeutic utility that it should not be marketed at all, and may need evidence undermining the drug’s accepted risk–benefit profile or identifying comparably effective safer alternatives.

## Conclusion

The court entered judgment for the manufacturer, holding that physician-directed warnings were adequate under the learned intermediary doctrine and that, absent substantial evidence that the drug’s risks outweighed its therapeutic benefits notwithstanding those warnings and FDA approval, the drug could not be deemed unreasonably dangerous per se.


Williams v. Ciba-Geigy Corp., 686 F. Supp. 573 (W.D. La. 1988)