## Facts

- A mother brought a wrongful-death and products-liability action alleging her child’s severe birth defects and death were caused by her ingestion of Accutane (isotretinoin) during pregnancy.
- Accutane was an FDA-approved prescription drug for serious acne, marketed in the United States beginning in 1982.
- The mother took Accutane in late 1982 pursuant to her physician’s prescription while pregnant.
- The package insert then in effect contraindicated Accutane for patients who were pregnant or intended to become pregnant, and stated that women of childbearing potential should not receive it unless using effective contraception and fully counseled about fetal risks.
- The insert also warned that, although no human fetal abnormalities had been reported at that time, animal studies suggested teratogenic effects might occur.
- There was conflicting evidence about what the physician communicated to the patient, but the physician testified he understood the warning that Accutane should not be used in pregnancy.
- The trial court granted summary judgment for the manufacturer, holding the warning adequate as a matter of law; the district court affirmed.

## Issues

1. Whether the adequacy of a prescription-drug manufacturer’s warning to the prescribing physician may be decided as a matter of law on summary judgment when the warning is detailed and specific.
2. Whether a plaintiff can prove proximate cause in a failure-to-warn claim when the prescribing physician understood the risk conveyed by the warning and there is no evidence a different warning would have changed the physician’s prescribing decision.

## Decision

- Summary judgment for the manufacturer was affirmed.
- The warning regarding use during pregnancy was legally adequate under the learned-intermediary doctrine.
- Independently, proximate cause was not shown because the prescribing physician understood the relevant risk and there was no evidence that any different or additional warning would have altered the physician’s conduct.

## Legal Principles

- For prescription drugs, the manufacturer’s duty to warn generally runs to the prescribing physician, who acts as a learned intermediary between manufacturer and patient.
- Warning adequacy is often fact-bound, but may be resolved as a matter of law where the warning is clear, specific, and reasonable persons could not differ as to its sufficiency.
- Failure-to-warn liability requires proof of proximate cause: the plaintiff must show that an adequate warning would have changed the physician’s prescribing decision or other relevant conduct.
- When the prescribing physician testifies to understanding the substance of the risk addressed by the warning and there is no evidence a different warning would have changed the outcome, causation may fail as a matter of law.

## Conclusion

The court affirmed summary judgment because the Accutane pregnancy warning adequately warned the prescribing physician and, in any event, the plaintiff could not establish that an allegedly different warning would have changed the physician’s conduct and prevented the injury.


Felix v. Hoffmann-La Roche, Inc., 540 So. 2d 102 (Fla. 1989)