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MacDonald v. Ortho Pharmaceutical Corp. - 394 Mass. 131, 475 N.E.2d 65 (1985)


The rule in jurisdictions that have addressed the question of the extent of a manufacturer's duty to warn in cases involving prescription drugs is that the prescribing physician acts as a learned intermediary between the manufacturer and the patient, and the duty of the ethical drug manufacturer is to warn the doctor, rather than the patient, although the manufacturer is directly liable to the patient for a breach of such duty. Oral contraceptives, however, bear peculiar characteristics which warrant the imposition of a common law duty on the manufacturer to warn users directly of associated risks.


In Sept. 1973, plaintiff Carole D. MacDonald obtained from her gynecologist a prescription for Ortho-Novum contraceptive pills, manufactured by defendant Ortho Pharmaceutical Corporation ("Ortho"). As required by the then-effective federal regulations, the pill dispenser MacDonald received was labeled with a warning 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 warning also referred MacDonald to a booklet, which she obtained from her gynecologist, and which was distributed by Ortho pursuant to federal requirements. The booklet contained detailed information about the contraceptive pill, including the increased risk to pill users that vital organs such as the brain may be damaged by abnormal blood clotting; however, the word "stroke" did not appear in the pill dispenser nor the booklet. After approximately three years of using the pills, MacDonald suffered a stroke that left her permanently disabled. Thereafter, MacDonald and her husband, plaintiff Bruce MacDonald, initiated an action in the Superior Court of Massachusetts against Ortho, seeking recovery for MacDonald's personal injuries; Bruce sought consequential damages and loss of consortium. At trial, MacDonald testified that during the time she used the pills, she was unaware that the risk of abnormal blood clotting encompassed the risk of stroke, and that she would not have used the pills had she been warned that stroke is an associated risk. The case was submitted to a jury on plaintiffs' theories that Ortho was negligent in failing to warn adequately of the dangers associated with the pills and that Ortho breached its warranty of merchantability. The jury returned a special verdict, finding no negligence or breach of warranty in the manufacture of the pills. The jury also found that Ortho adequately advised the gynecologist of the risks inherent in the pills; the jury found, however, that Ortho was negligent and in breach of warranty because it failed to give MacDonald sufficient warning of such dangers. The jury further found that MacDonald's injury was caused by Ortho's pills, that the inadequacy of the warnings to MacDonald was the proximate cause of her injury, and that Ortho was liable to MacDonald and her husband. After the jury verdict, the judge granted Ortho's motion for judgment notwithstanding the verdict, concluding that, because oral contraceptives were prescription drugs, a manufacturer's duty to warn the consumer was satisfied if the manufacturer gave adequate warnings to the prescribing physician, and that the manufacturer had no duty to warn the consumer directly. Plaintiffs appealed.


Did Ortho have a duty to warn directly MacDonald and other consumers of the dangers inherent in using birth control pills?




The Supreme Judicial Court of Massachusetts reversed the trial court's judgment and remanded the cause to the trial court for entry of judgment in plaintiffs' favor. The court held that oral contraceptives bore peculiar characteristics requiring the manufacturer to directly warn users of the associated risks. According to the court, Ortho had a duty to provide written warnings conveying reasonable notice of nature, gravity, likelihood of known or knowable side effects, and advising MacDonald and other consumers to consult a physician for further explanation—Ortho could not only rely on warnings to medical professionals to satisfy common law duty to warn. The court concluded that the warning had to be comprehensible to the average user and convey a fair indication of the nature and extent of the danger to the mind of a reasonably prudent person.

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