Sample Prescription Drugs and the "Learned Intermediary": Liability without Preemption

Susan Poser, University of Nebraska

Abstract

This is the first article that undertakes a systematic legal analysis of the issue of liability for harm from sample prescription drugs. I propose in this Article that people who suffer injuries resulting from the absence of warnings on samples of prescription drugs be permitted to sue drug manufacturers directly in tort, the learned intermediary rule notwithstanding. I show that the various rationales for the learned intermediary doctrine do not apply to sample prescription drugs. I use empirical studies to show that the drug companies’ promotion, marketing, and packaging of sample prescription drugs put patients at risk and tort law should require these companies to absorb those risks when they result in foreseeable harm. Recognition of an exception to the learned intermediary rule in the case of prescription drug samples would spread the risk of harm from unlabeled prescription drugs between physicians and the drug companies in a way that more accurately accounts for their responsibility for that risk. Moreover, recent pronouncements by the federal Food and Drug Administration concerning the preemptive effect of its drug labeling regulations should not affect this analysis. The FDA’s failure to require patient labeling on sample medication is not based on carefully considered scientific evidence. Imposing state tort liability on pharmaceutical manufacturers for failure to warn on samples of prescription drugs would not conflict with any of the FDA’s regulatory purposes or goals.