MacDonald v. Ortho Pharmaceutical Corp.

Supreme Judicial Court of Massachusetts · 1985 · Torts

TortsProducts liabilityFailure to warnPrescription drugsOral contraceptivesfailure to warnoral contraceptiveslearned intermediary

Facts

Carole MacDonald received Ortho-Novum oral contraceptive pills from her gynecologist beginning in 1973 and continued using them through annual prescription renewals. The dispenser warning and accompanying booklet warned of abnormal blood clotting, including clots in vital organs such as the brain, but neither used the word "stroke." In 1976, after about three years of use, MacDonald suffered a cerebral artery occlusion by a blood clot that caused permanent disability. She testified that she did not understand the warnings to include a risk of stroke and that she would not have used the pills had she been warned of that risk.

Issue

Whether a manufacturer of oral contraceptive pills satisfies its duty to warn by adequately warning the prescribing physician, or instead owes a direct duty to warn the consumer of the dangers inherent in use of the pill. Also, whether the evidence was sufficient to permit the jury to find that Ortho's warning to MacDonald was inadequate and that the inadequacy proximately caused her injury.

Rule

Ordinarily a manufacturer must warn foreseeable users of dangers inherent in its product, and reliance on an intermediary discharges that duty only when such reliance is reasonable. Because oral contraceptives have distinctive features, including active consumer choice, substantial risks, feasibility of direct written warnings, limited physician contact, and the possibility that oral physician communications are insufficient, a manufacturer of oral contraceptives must provide the consumer written warnings conveying reasonable notice of the nature, gravity, and likelihood of known or knowable side effects and advising the consumer to seek fuller explanation from a physician. Compliance with FDA labeling requirements is admissible on negligence but does not conclusively define or satisfy the common-law duty to warn.

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One of 10 multiple-choice questions for this case. Pick an answer to see why.

In Boston, Mira Solis obtained prescription birth-control pills from her gynecologist and then received annual renewals for the next two years. The manufacturer sent detailed risk information only to physicians and pharmacies, but included no written warning for patients in the package. After suffering a serious clot-related injury, Mira sues the manufacturer for failure to warn even though her doctor had been fully warned.

Under the majority rule, which is the strongest argument for Mira?

Explanation. The majority held that the learned intermediary principle does not automatically govern oral contraceptives. Because of the product's distinctive features—active consumer choice, substantial risks, limited physician contact, and the feasibility and importance of direct written warnings—the manufacturer must provide written warnings to the user. Adequate warning to the physician alone does not discharge that duty. (Derived from MacDonald v. Ortho Pharmaceutical Corp. (n.d.).)