Brief Fact Summary. MacDonald (Plaintiff) suffered a stroke after taking birth control pills manufactured by Ortho Pharmaceutical Corp. (Defendant). Plaintiff sued Defendant for products liability for their failure to warn.
Synopsis of Rule of Law. The common law duty to warn necessitates a warning comprehensible to the average user, which conveys a fair indication of the nature and extent of the danger to the mind of a reasonably prudent person.
Issue. Must a drug manufacturer of an oral contraceptive directly warn consumers of a drug’s inherent dangers?
Held. Yes. Judgment reversed.
* The pill taken by Plaintiff stands apart from other prescription drugs. The pill has substantial risks affiliated with the products use, it is easy for manufacturers of the pill to warn consumers, and physicians prescribing the pill only see the patient once a year. Because of these differences, Defendant, a manufacturer of the pill, is not justified in relying on warnings to the medical profession to satisfy its common law duty to warn. Defendant is under a duty to warn the ultimate consumer, Plaintiff.
* The common law duty to warn necessitates a warning comprehensible to the average user, which conveys a fair indication of the nature and extent of the danger to the mind of a reasonably prudent person. A jury may determine that a manufacturer’s compliance with FDA labeling requirements or guidelines did not adequately apprise oral contraceptive users of inherent risks; the manufacturers should not be shielded from liability by such compliance.
* The jury decides whether or not a warning is adequate. The jury may have concluded that the absence of a reference to “stroke” in the warning unduly minimized the warning’s impact or failed to make the nature of the risk reasonably comprehensible to the average consumer.
Dissent. (Justice O’Connor) Defendant adequately warned the consumer by warning the physician.
Discussion. In this case, the court points out how easy is it to warn Plaintiff of the possible side effects and risks of the pill. The question for the jury is how much warning is enough? Obviously the word “stroke” should not have been omitted. The adequacy of warnings varies from case to case, and from jury to jury