Too Many Alerts, Too Much Liability

Sorting Through the Malpractice Implications of Drug-Drug Interaction Clinical Decision Support

Published in: St. Louis University Journal of Health Law & Policy, v. 5, no. 2, June 2012, p. 257-296

by M. Susan Ridgely, Michael D. Greenberg

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OBJECTIVE: New electronic clinical decision support (CDS) systems are intended to reduce medical errors but sometimes have the unexpected and perverse effect of overwhelming physicians with potential warnings about trivial events, particularly regarding drug-drug interactions. This glut of warnings can produce "alert fatigue," causing physicians to "tune out" interaction alerts and exposing themselves to enhanced liability. This paper examines the liability issues surrounding a potential Drug-Drug Interaction (DDI) list, proposed as a way to deliver only optimal interaction warnings and reduce the number of warnings physicians receive. METHODS: The paper describes CDS and the DDI lists, describing their potential benefits and risks; next, it reviews the fundamentals of medical malpractice liability and product liability as these concern medical software and discusses what legal theory and existing case law suggest about how courts might treat CDS and in particular a clinically significant DDI list. RESULTS: The paper identified and assessed the merits of five public policy strategies for establishing liability protection for providers who use a clinically significant DDI list and the vendors that incorporate it. CONCLUSIONS: Assuming that a government regulator like the Office of the National Coordinator for Health Information Technology has the power to endorse or certify a DDI list, and assuming that the agency exercises that power non-negligently, then the potential for civil liability under the Federal Tort Claims Act appears low.

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