## Facts

- John T. Edwards used Habitrol, a prescription nicotine patch manufactured by Basel Pharmaceuticals.
- He wore two Habitrol patches while also smoking cigarettes and died of a nicotine-induced heart attack.
- The estate alleged the product was unreasonably dangerous because the patient insert failed to adequately warn consumers about the risk of fatal nicotine overdose from smoking while using the patch.
- Basel provided relatively thorough risk warnings to prescribing physicians, but the patient insert did not mention possible fatal or serious cardiac consequences, warning only that an overdose “might cause you to faint.”
- In the federal wrongful-death products-liability suit, Basel relied on the learned intermediary doctrine and asserted it complied with FDA requirements for patient-directed warnings.
- The Oklahoma Supreme Court addressed the matter on a certified question from the U.S. Court of Appeals for the Tenth Circuit, assuming for purposes of the question that Basel complied with FDA direct-warning requirements.

## Issues

1. When the FDA requires direct-to-patient warnings for a prescription drug, what is the scope of the manufacturer’s duty to warn consumers under Oklahoma law, given the resulting exception to the learned intermediary doctrine?
2. Does compliance with FDA warning requirements automatically satisfy the manufacturer’s Oklahoma common-law duty to warn the consumer, or is warning adequacy still a state-law question for the fact-finder?

## Decision

- The court answered that when FDA rules require direct consumer warnings, the learned intermediary doctrine is undercut to that extent and an exception applies requiring a duty to warn the consumer directly.
- The court held that compliance with FDA warning requirements does not necessarily satisfy the manufacturer’s common-law duty to warn consumers under Oklahoma law.
- FDA compliance may be relevant evidence of adequacy, but it is not dispositive; the adequacy of the consumer warning remains governed by state products-liability standards and requires fact-finding.
- The court returned the case to the federal court to apply these rules to the underlying dispute.

## Legal Principles

- Under Oklahoma products-liability law, manufacturers must warn of dangers they know or reasonably should know; for prescription drugs, this duty is ordinarily discharged by adequate warnings to the prescribing physician (learned intermediary doctrine).
- When the FDA requires patient-directed warnings, an exception to the learned intermediary doctrine applies, and the manufacturer’s duty includes providing adequate warnings directly to consumers.
- Regulatory compliance with FDA labeling and patient-insert requirements does not automatically establish that a warning is adequate for Oklahoma tort purposes; adequacy remains a state-law issue for the trier of fact.

## Conclusion

Oklahoma law recognizes that FDA-required patient warnings create an exception to the learned intermediary doctrine, and it rejects a rule that FDA-compliant consumer labeling, by itself, conclusively fulfills a prescription drug manufacturer’s duty to warn consumers.


Edwards v. Basel Pharms., 933 P.2d 298 (Okla. 1997)