Drug Advertising Claims: Preemption's New Frontier

28 Pages Posted: 4 Feb 2009 Last revised: 2 Jun 2013

Date Written: February 4, 2009


To date, the U.S. Supreme Court's focus has been on preemption of traditional tort claims impugning the safety of medical devices and drugs either through design defect or failure-to-warn claims. Even if the Court forecloses such tort claims, in whole or in part, most likely the nascent, but ever-expanding, realm of related consumer fraud claims arising from prescription drug advertising will emerge unscathed.

The historical model for an end run around preemption of failure-to-warn claims is provided by the watershed case Cipollone v. Liggett Group, which forged a distinction between health and safety specific failure-to-warn claims - which were expressly preempted under the federal cigarette labeling statute - and general fraudulent misrepresentation claims - which were not preempted. Altria Group, Inc. v. Good, decided this Term breathes new life into efforts to structure state law fraud claims around federal preemption.

The crux of the preemption debate centers on whether the decision-maker adjudges the FDA's regulation a floor (or minimal) or ceiling (or optimal) standard-the former permitting complementary state actions; the latter foreclosing them as meddlesome substitutes. The FDA's advertisement review process appears to provide a (rather weak) floor rather than an optimal regulatory standard. On the whole, the FDA does not appear to be engaged in an exercise of optimization, weighing the costs and benefits of the DTCA. For this reason, it would be rare for pursuit of the state law tort action to be characterized as a "redo" of what the FDA has already determined. And thus, consumer fraud claims arising from drug advertisements should withstand preemption challenges.

Suggested Citation

Sharkey, Catherine M., Drug Advertising Claims: Preemption's New Frontier (February 4, 2009). Loyola of Los Angeles Law Review, Forthcoming, NYU School of Law, Public Law Research Paper No. 09-05, NYU Law and Economics Research Paper No. 09-05, Available at SSRN: https://ssrn.com/abstract=1337617

Catherine M. Sharkey (Contact Author)

New York University School of Law ( email )

40 Washington Square South
New York, NY 10012-1099
United States
212-998-6729 (Phone)

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