## Facts

- Carole D. MacDonald obtained a prescription in 1973 for Ortho-Novum oral contraceptive pills from her gynecologist; her husband asserted a related loss-of-consortium claim.
- The dispenser included an FDA-required warning stating oral contraceptives can cause side effects, and that the most serious known side effect is abnormal blood clotting that can be fatal.
- The warning directed users to a manufacturer-supplied booklet describing increased risks that vital organs, including the brain, may be damaged by abnormal blood clotting, but neither the label nor the booklet used the term “stroke.”
- MacDonald renewed the prescription annually and used the pills for about three years.
- In 1976, she suffered an occlusion of a cerebral artery (stroke), causing substantial brain tissue death and permanent disability.
- MacDonald testified she did not know the pill posed a stroke risk and would not have taken it if explicitly warned of stroke.
- A jury found for the plaintiffs on a failure-to-warn theory; the trial judge entered judgment notwithstanding the verdict for the manufacturer based on the learned intermediary doctrine.
- The Supreme Judicial Court of Massachusetts reversed and reinstated the jury verdict.

## Issues

1. Whether a manufacturer of oral contraceptive pills has a common-law duty to warn the consumer directly, or may satisfy its duty solely by warning the prescribing physician under the learned intermediary doctrine.
2. Whether the manufacturer’s written warnings were adequate as a matter of law, including whether omission of the term “stroke” could render the warnings insufficient.
3. Whether any inadequacy in the consumer warning was a proximate cause of the plaintiff’s injury.

## Decision

- The court held that manufacturers of oral contraceptives owe consumers a direct common-law duty to provide written warnings that reasonably inform users of serious risks.
- The court concluded that, on these facts, adequacy of the warning and causation were for the jury and were not resolved as a matter of law.
- The court ruled that compliance with FDA labeling requirements did not automatically satisfy the common-law duty to warn.
- The court reversed the judgment notwithstanding the verdict and reinstated the jury’s verdict for the plaintiffs.

## Legal Principles

- For oral contraceptives, the learned intermediary doctrine does not, by itself, relieve the manufacturer of a duty to warn the consumer directly in writing.
- A consumer warning for oral contraceptives must be comprehensible to the average user and give reasonable notice of the nature, gravity, and likelihood of known or knowable side effects, while advising the user to consult a physician about concerning information.
- FDA compliance is evidence bearing on reasonableness but does not preclude a finding that a warning is inadequate under state common law.
- Warning adequacy and proximate causation generally present jury questions when reasonable factfinders could conclude that clearer, more specific risk communication would have altered the consumer’s decision to use the product.

## Conclusion

Massachusetts recognized a direct-to-consumer warning duty for oral contraceptive manufacturers and held that a jury could find a warning inadequate when it communicated clotting risks without explicitly identifying “stroke,” and could also find causation based on testimony that an explicit stroke warning would have changed the user’s conduct.


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