Failure to Warn: Facing Up to the Real Impact of Pharmaceutical Marketing on the Physician's Decision to Prescribe

Abstract

Pharmaceutical side effects cause more than 100,000 deaths per year. Because pharmaceuticals pose serious risks, the Food and Drug Administration carefully vets the written warnings that physicians receive about each drug. But alongside these official warnings, attractive pharmaceutical representatives offer slick sales pitches in what amounts to a billion-dollar campaign aimed at influencing the physician’s judgment. Pharmaceutical representatives are known to downplay the package insert’s warnings. Based on social science research, the marketing operates at a subconscious level, so targeted physicians are often unaware of its surreptitious effects. Nonetheless, pharmaceutical company defendants in failure-to-warn lawsuits can often obtain summary judgment based purely on the package insert, while the pervasive — and effective — warning-diluting marketing information is ignored.

This article proposes that the failure-to-warn inquiry face up to pharmaceutical marketing’s potent role in many prescribing decisions. Courts assessing a warning’s adequacy cannot stop at the package insert but must consider the warning-diluting marketing information as well. And when causation is the question, the physician’s testimony should not be conclusive as to the marketing information’s effects. Failure-to-warn jurisprudence should stop relying on empty paper compliance and recognize present-day pharmaceutical marketing as a compelling and driving force in the decision to prescribe.