MacDonald v. Ortho Pharmaceutical Corp.

Supreme Judicial Court of Massachusetts, Worcester
475 N.E.2d 65 (1985)

ELI5:

Rule of Law:

A manufacturer of oral contraceptives has a common law duty to warn the end-user directly of the risks associated with the drug; this duty is not discharged by merely providing warnings to the prescribing physician under the 'learned intermediary' doctrine.

Facts:

In September 1973, Carole D. MacDonald, then 26 years old, obtained a prescription for Ortho-Novum oral contraceptives, manufactured by Ortho Pharmaceutical Corporation.
The pill dispenser contained a warning about the risk of 'abnormal blood clotting which can be fatal.'
MacDonald also received a booklet from Ortho which warned that blood clots could form in vital organs, including the brain.
Neither the dispenser warning nor the booklet specifically used the word 'stroke.'
MacDonald used the pills for approximately three years, with her prescription being renewed annually.
On July 24, 1976, MacDonald suffered an occlusion of a cerebral artery, commonly known as a stroke, which was caused by a blood clot.
The stroke resulted in the death of 20% of her brain tissue and left her permanently disabled.
MacDonald testified that she was unaware the risk of 'abnormal blood clotting' encompassed the risk of stroke and would not have taken the pills if she had been explicitly warned of it.

Procedural Posture:

Carole D. MacDonald and her husband sued Ortho Pharmaceutical Corporation in the Superior Court (trial court).
The case was tried before a jury on claims of negligent failure to warn and breach of warranty.
The jury returned a verdict for the plaintiffs, finding that Ortho had failed to provide an adequate warning to MacDonald directly, and that this failure caused her injuries.
Ortho filed a motion for judgment notwithstanding the verdict (JNOV).
The trial court judge granted Ortho's motion for JNOV, ruling as a matter of law that Ortho's duty to warn was fulfilled by warning the prescribing physician.
The plaintiffs appealed the judge's order granting the JNOV.
The state's highest court transferred the case for review on its own motion.

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Issue:

Does a manufacturer of oral contraceptives have a legal duty to warn the consumer directly of the risks associated with the product, or is its duty discharged by adequately warning the prescribing physician?

Opinions:

Majority - Abrams, J.

Yes, a manufacturer of oral contraceptives owes a direct duty to the consumer to warn her of the dangers inherent in the use of the pill. The traditional 'learned intermediary' rule, which allows a manufacturer to discharge its duty by warning the prescribing physician, does not apply to oral contraceptives. This exception is warranted because the patient is highly involved in the decision to use the product, the prescribing physician plays a relatively passive role with limited interaction (e.g., annual prescription renewals), and federal regulations already recognize the necessity of direct-to-consumer written information. Therefore, the manufacturer has an independent duty to provide consumers with understandable warnings about the nature, gravity, and likelihood of known side effects. The adequacy of a warning, including whether the omission of a specific term like 'stroke' renders it insufficient, is a question for the jury, and compliance with FDA regulations is not a conclusive defense.

Dissenting - O'Connor, J.

No, a manufacturer of oral contraceptives fulfills its duty to warn consumers by adequately informing prescribing physicians of the product's risks and complying with applicable FDA regulations. The court should have applied the well-established 'prescription drug' or 'learned intermediary' rule, which correctly places the responsibility of communicating risks on the physician, who can tailor information to the individual patient's medical history and needs. Doctors, not manufacturers, are best positioned to have this crucial conversation. The majority creates an unwarranted exception based on unproven assumptions about the physician's passive role. Ortho's warning about potentially fatal blood clots in the brain was legally sufficient, and the company should not be held liable for failing to use the specific word 'stroke.'

Analysis:

This landmark decision carves out a significant exception to the widely accepted learned intermediary doctrine for oral contraceptives. By imposing a direct duty to warn consumers, the court acknowledged the unique context of contraceptive use, characterized by patient autonomy, elective use by healthy individuals, and limited physician interaction. This ruling increased the potential liability for pharmaceutical manufacturers in this sector, establishing that compliance with FDA regulations and warnings to physicians are not absolute shields against failure-to-warn claims. The case emphasizes that the adequacy of a warning will be judged from the perspective of an average consumer, making specific word choices potentially critical, jury-decided issues in future litigation.

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