111 Iowa L. Rev. 1181 (2026)

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Abstract

Manufacturers that promote unapproved “off-label” uses of their drugs and devices can cause harm to patients by encouraging providers to prescribe these products unsafely. Examples of this phenomenon are increasingly in the news, as patients injured by off-label uses of drugs like Botox sue manufacturers that promote them. Yet these claims often fail because the current legal framework is ill-equipped to deal with this problem. In some cases, for example, the First Amendment stymies lawsuits by protecting manufacturers’ promotional speech. In others, the doctrine of preemption blocks claims because federal law regulating drugs or devices conflicts with state law that imposes liability on manufacturers. The result is problematic: Manufacturers that cause injuries to patients by promoting off-label uses may be immune from liability. 

This Article proposes a solution: a new theory of liability—off-label inducement—that makes a manufacturer liable when its promotion induces a provider to negligently prescribe, administer, or use its drug or device off-label. In other words, manufacturers actively encouraging off-label uses that constitute and result in negligent medical care should be liable for the injuries they cause. While tort law supplies the framework for the theory, intellectual property law provides additional support for why it should apply to manufacturers that promote unsafe off-label uses of drugs and devices. Courts have adapted inducement in intellectual property law to address new social problems, such as widespread infringement enabled by file-sharing software. To respond to the harms posed by off-label promotion, courts should do the same with tort law. Manufacturers actively encouraging off-label uses that constitute and result in negligent medical care should be liable for many of the same policy reasons distributors of software are liable for encouraging consumers to infringe intellectual property using their products. After describing the theory, it demonstrates how three different formulations of it could apply to a recent case. The Article then explains how off-label inducement overcomes constitutional and doctrinal obstacles that frustrate traditional attempts to hold manufacturers responsible for harms they cause through off-label promotion. Using this theory to hold manufacturers responsible for the harm they cause by promoting unsafe off-label uses can help to reduce injuries, improve care, and compensate injured patients.