Summary of MacDonald v. Ortho Pharmaceutical Corp, S. Ct. Massachusetts [1985]

Defective Instructions & Warnings

Relevant Facts: Pl, Carole M, obtained from her GYN a prescription for contraceptive pills manufactured by Ortho.  The pill dispenser was labeled with a warning and referred her to a booklet for additional info, including increased risks.  The word stroke never appears.  Her prescription was renewed annually,‘73, ‘74, ‘75.  In 1976 after 3 yrs of use, she suffered a blood clot in her brain, a stroke. 11 mos had elapsed between her last GYN checkup and her stroke.

Legal Issue(s): Whether Ortho owed a duty to MacDonald to warn her of the dangers inherent in the use of the pill; and whether the evidence was insufficient to warrant the jury’s finding that the warnings were inadequate?

Court’s Holding: Yes, and No

Procedure: Jury verdict for PL, granted manufacturer’s MNOV; S. Ct Reversed/Remanded entry for the PL.

Law or Rule(s): A manufacturer of a product, which the manufacturer knows or should know is dangerous by nature or is in a dangerous condition, is under a duty to give warning of those dangers to persons who it is foreseeable will come in contact with, and consequently be endangered by, that product.

Court Rationale: A manufacturer may be absolved of liability b/c of a justified reliance upon a intermediary only when that reliance is reasonable.  If the consumer does not receive the warning b/c of the intermediary’s failure to warn was the superceding cause of the injury, or b/c it is unreasonable to expect the manufacturer to communicate with consumer, the manufacturer has not duty directly to warn the consumer.  A physician prescribing oral contraceptives is relegated to a relatively passive role.   Manufacturer of oral contraceptives is not justified in relying on warnings to physician to satisfy CL duty to warn, and the obligation encompasses a duty to warn the ultimate user.  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 the physician.  The adequacy of warnings is measured not only by what is stated, but also by the manner in which it is stated.  A reasonable warning not only conveys a fair indication of the nature of the dangers involved, but also warns with the degree of intensity demanded by the nature of the risk.

Plaintiff’s Argument: Ortho was negligent in failing to adequately warn of the dangers associated with the pills and that Ortho breached it warranty of merchantibility.

Defendant’s Argument: The Df adequately warned the physician of the inherent dangers and placed a printed warning on the package itself notifying the user of the known dangers.

Prescription Rule :If the prescribing physician is acting as a learned intermediary between the manufacturer and the consumer, then the manufacturer’s duty is to warn the doctor, rather than the patient, although the manufacturer is directly liable to the patient for a breach of such a duty.