OFF-LABEL PREEMPTION

A significant body of scholarship examines when federal law regulating drugs and devices preempts state law claims against manufacturers for defective products based on uses approved by the Food and Drug Administration (FDA)-what are called on-label uses. Yet scholars have paid little attention to how preemption applies to claims against manufacturers that promote uses FDA has not approved-what are called off-label uses. The omission is significant. Off-label use is widespread (comprising a significant portion of all uses) and risky (frequently unsupported by scientific evidence). In private lawsuits against manufacturers that promote off-label uses, preemption is often the linchpin issue. Courts analyzing whether federal law preempts state law claims based on off-label promotion have reached wildly inconsistent results. Despite the issue's importance, few scholars have systematically evaluated the off-label preemption landscape or provided a coherent rationale for how courts should apply preemption doctrine to state law claims based on off-label promotion. This Article does both by developing an approval theory of off-label preemption that anchors doctrinal analysis to FDA's central function: ex ante risk evaluation of approved uses of drugs and devices. Emphasizing FDA ex ante review of use-based risks delivers three significant payoffs. First, it provides an organizing principle that explains the Supreme Court's seemingly fractured preemption jurisprudence. Second, the theory unifies conflicting approaches to preemption of state law claims based on off-label promotion. Finally, it offers a normative reason for why preemption should not apply to most state law claims based on off-label promotion of any drug or device.