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Executive Summary

ORTHO-NOVUM PRODUCT LIABILITY SUIT: ORAL CONTRACEPTIVES' "UNIQUENESS" among Rx products requires a mfr. to warn the consumer directly of the "nature, gravity and likelihood of known or knowable side effects," the Massachusetts Supreme Court ruled in a decision that was left standing by the U.S. Supreme Court Oct. 21. The federal Supreme Court refused to review the case. At issue in Carole MacDonald v. Ortho is the extent of a drug mfr.'s duty to warn consumers of dangers inherent in the use of oral contraceptives. The state supreme court ruled that Ortho's warnings in Ortho-Novum patient labeling were inadequate and that reliance on warnings to physicians was not justified. Oral contraceptives "bear peculiar characteristics which warrant the imposition of a common law duty on the mfr. to warn users directly of associated risks," the court stated. "Whereas a patient's involvement in decision-making concerning use of a prescription drug necessary to treat a malady is typically minimal or nonexistent, the healthy, young consumer of oral contraceptives is usually actively involved in the decision to use 'the pill,' as opposed to other available birth control products, and the prescribing physician is relegated to a relatively passive role." Ortho requested the Supreme Court to review the case in a certiorari writ filed Aug. 29. The firm maintained that the state court made up the "peculiar characteristics" of oral contraceptives. "In so doing, it cited no evidence in the record to support its conclusion that OCs are somehow peculiar among Rx drugs. No such evidence exists in the record or in the real world," Ortho stated. The state supreme court also ruled that Ortho's warning statement could be determined to be inadequate. The warning at question in the suit stated: "Oral contraceptives are powerful and effective drugs which can cause side effects in some women . . . The most serious known side effect is abnormal blood clotting which can be fatal." Ortho argued that the warning is in compliance with FDA-mandated language which does not use the term "stroke." The state supreme court decided, however, that "the jury may well have concluded, in light of their commn experience and MacDonald's testimony, that the absence of a reference to 'stroke' in the warning unduly minimized the warning's impact or failed to make the nature of the risk reasonably comprehensible to the average consumer." Ortho-Novum labeling was altered seven years ago to include the term "stroke" in the warning. The state supreme court decision issued in February 1985 reinstated a jury verdict and overturned the trial court's August 1983 ruling that Ortho had a duty to warn only the prescribing physician. The jury in the trial court found that Ortho had adequately warned MacDonald's physician of the dangers of OCs, but had not adequately warned her of such dangers and that the inadequate patient warnings caused her stroke. The Supreme Court's refusal to hear the case lets stand the award of $800,000 to Ms. MacDonald and $50,000 to her husband. The original case was filed in 1976.

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