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Practice Tip: The Learned Intermediary Doctrine

By Diane E. Lifton and Michelle M. Bufano

Recently, notwithstanding the defense's adoption in the majority of states, the Supreme Court of Appeals of West Virginia, in Johnson & Johnson v. Karl, declined to adopt the learned intermediary doctrine. The court concluded, incorrectly, that direct-to-consumer advertising (specifically in the context of pharmaceuticals) has eliminated the role of the prescribing physician in educating patients regarding the risks of prescription drugs. As set forth more fully below, this holding and its underlying rationale: 1) ignores and undervalues the duty of a physician to exercise medical judgment in the prescribing of drugs and medical devices based on his or her patient's individual and specific needs; 2) undermines the federal regulatory scheme that requires pharmaceutical and device manufacturers to provide warnings to physicians; and 3) deprives pharmaceutical companies of a long-standing, valid defense, apparently solely because, like all manufacturers, such companies benefit financially from the sale of their products. As set forth herein, however, the very same reasons that prompted the development of the learned intermediary doctrine more than a half-century ago remain relevant and applicable today.

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