There is no express federal preemption for drugs, right?
Wrong! Today we expound on a flavor of preemption that we don’t often get around to—express preemption for claims related to non-prescription, over-the-counter drugs. Under section 379r of the FDCA, no state may establish any requirement that relates to a non-prescription drug and “that is different from or in addition to, or that is otherwise not identical with” a federal requirement. 28 U.S.C. § 379r(a). The “different from or in addition to” language rings familiar from medical device express preemption that we write on multiple times each month (such as here), and as if that were not clear enough, Congress drove the point home with the “otherwise not identical with” language.
So there you have it. Express preemption in connection with drugs, albeit not the prescription drugs that usually occupy us, and not without significant exceptions. The FDA can grant exemptions to the preemption rule under certain circumstances, and the provision does not preempt (1) state regulation of pharmacies or (2) any state requirement that a drug be dispensed only upon by an authorized prescription. Id. § 379r(b), (c). The really big exception is that the provision does not preempt product liability claims, Id. § 379r(e), so if we’re faced with claims alleging personal injury attributed to use of an allegedly defective non-prescription drug, express preemption will probably not come into play.
But that does not mean that OTC express preemption does not have teeth. In Bowling v. Johnson & Johnson, No. 14-cv-3727, 2014 U.S. Dist. LEXIS 155899 (S.D.N.Y. Nov. 4, 2014), the plaintiffs alleged that the label on a popular brand of mouthwash falsely claimed that use would “Restore Enamel.” Id. at *2. According to the plaintiffs, loss of tooth enamel is permanent, making it “physically impossible” to restore enamel. Id. Based on this allegation, the plaintiffs alleged violations of multiple state statutes (the order does not say which statutes, but we presume they were statutes of the consumer fraud type) and the federal Magnuson-Moss Warranty Act, which governs warranties on consumer products. Id. at *1.