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Practice Tip: Failure-to-Warn Causation and The Learned Intermediary

By Lori G. Cohen and Daniel I.A. Smulian

In pharmaceutical and medical device litigation, the failure-to-warn claim continues to be among the most common causes of action. With respect to pharmaceutical products, the relative ease of asserting this claim stands in stark contrast to the difficulty of proving either a manufacturing or design defect. With respect to medical devices, the failure-to-warn claim remains prevalent despite the preemption afforded by Riegel v. Medtronic, 552 U.S. 312 (2008), particularly when the claim is premised on or combined with allegations involving the actions or statements of sales representatives. While not conceptually complex, failure-to-warn claims involving pharmaceutical and medical devices raise specific issues that can be challenging. One of the most critical issues relates to causation and its intersection with the learned intermediary doctrine. This article examines some of the key factors involved in proving causation in a failure-to-warn case and discusses recent case law in this area.

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