Edwards v. Basel Pharm.

116 F.3d 1341 (10th Cir. 1997)



When the Food and Drug Administration (FDA) requires warnings be given directly to the patient with a prescribed drug, an exception to the "learned intermediary doctrine" occurs, and the manufacturer is not automatically shielded from liability by properly warning the prescribing physician. When this happens the manufacturer's duty to warn the consumer is not necessarily satisfied by compliance with FDA minimum warning requirements. The required warnings must not be misleading, and must be adequate to explain to the user the possible dangers associated with the product. Whether that duty is satisfied is governed by the common law of the state.


Plaintiff widow filed a wrongful death action after her husband suffered a fatal heart attack while smoking cigarettes and wearing two of defendant pharmaceutical company's nicotine patches. Plaintiff advanced a theory of liability based on defendant's failure to warn of the risks of nicotine overdose resulting from smoking and overuse of the patch. Defendant filed a motion for summary judgment that was granted in the district court. Plaintiff successfully appealed. Defendant filed a petition for rehearing with suggestion for rehearing en banc. The court denied defendant pharmaceutical company's petition for rehearing en banc because it concluded the hearing panel's original disposition was correct.


Did the trial court err in granting summary judgment in favor plaintiff due to defendant's failure to comply with FDA warnings?




The court agreed with the panel who had certified a question to the Oklahoma Supreme Court as to the recognition of "learned intermediary rule" (LIR) in Oklahoma law. Defendant had asserted that the LIR limited its duty to warn to the prescribing physician. Plaintiff had contended that this case fell within a recognized exception to the LIR, applicable when the Food and Drug Administration (FDA) mandated that warnings be given to the patient and to the physician. The Oklahoma Supreme Court agreed with plaintiff. The court denied the petition because it was clear the defendant had not complied with the FDA warnings.

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