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MacDonald (P) received a prescription for contraceptive pills. These pills were manufactured by Ortho Pharmaceutical Corp. (D). The pill dispenser contained a warning required by the United States Food and Drug Administration, stating that 'oral contraceptives are powerful and effective drugs which can cause side effects in some users and should not be used at all by some women, ' and that 'the most serious known side effect is abnormal blood clotting which can be fatal.' The word 'stroke' did not appear either on the warning or the booklet referred to by the label. As a result of using these pills, P suffered a stroke and permanent brain damage. P sued D, claiming that D failed to properly warn consumers of the dangers associated with the pills. The jury returned a special verdict, finding no negligence or breach of warranty in the manufacture of the pills. The jury also found that D adequately advised the gynecologist of the risks inherent in the pills; the jury found that D was negligent and in breach of warranty because it failed to give P sufficient warning of such dangers. The jury found that D's pills caused P's injuries and that D was liable. However, after the jury verdict, the judge granted D's motion for judgment notwithstanding the verdict. The judge's reasoning was that because contraceptives are prescription drugs, a manufacturer's duty to warn the consumer is satisfied if the manufacturer gives adequate warnings to the prescribing physician. He concluded that the manufacturer has no duty to directly warn the consumer. P appealed.

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