From the Litigation Practice.

Defending Products Liability Suits Involving Off-Label Use: Does the Learned Intermediary Doctrine Apply?

February, 2011

Although the learned intermediary doctrine serves as a shield for manufacturers against consumer claims arising from allegations of failure to warn of a drug’s risks, physicians commonly engage in off-label use. It is impossible for manufacturers to warn physicians of every risk of any and all uses of a drug. But, court decisions that address whether the learned intermediary doctrine insulates manufacturers from claims based on off-label use vary widely across circuits. Given these varied approaches, this Article provides a survey of case law that may help those who defend drug manufacturers determine the relevant evidence and the likelihood that the learned intermediary doctrine will protect manufacturers faced with lawsuits in the jurisdictions discussed.

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