Law

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. 

We suppose the plaintiffs were seeking a refund for themselves and members of a class, but with regard to their state-law claims, they apparently did not bargain for preemption.  As the district court explained, the FDA regulates dental hygiene products such as fluoride mouthwash (which is a drug) by publishing monographs setting forth the drug labeling requirements.  According to the applicable monographs, manufacturers of products containing sodium fluoride are allowed (1) to represent that such drugs prevent tooth decay and (2) to provide further labeling to explain how.  Id. at **2-3.  Monographs are not the only way in which the FDA regulates non-prescription drugs:  Many OTC products are approved through New Drug Applications.  But in the absence of an NDA, the monographs provide vital regulation that the FDA can enforce, including through warning letters.  Notably, the FDA has sent multiple warning letters to manufacturers of OTC fluoride mouthwash, but never one expressing a concern over a statement like “Restores Enamel.”  Id. at **3-4.

The district court therefore dispatched the plaintiffs’ lawsuit with the stroke of a pen, and we like the court’s order for a few reasons.  First, the district court rejected the plaintiffs’ repeated attempts to invoke a “presumption against preemption” – a concept that we have railed on so many times we created a topiclabel by that name to catalog our multiple posts.  The district court called the plaintiffs’ citation to “food and beverage” cases “confused” and faulted them for invoking “a preemption standard that is wholly inapplicable to the case at hand.”  Id. at *5 n.17.  We think the “presumption against preemption” is wholly in applicable to every case, whether at hand or out of hand.  We are therefore glad that the district court rejected the so-called presumption, but wish only that it had done so even more emphatically.

Second, we like how directly the district court applied preemption to facts of the case.  The plaintiffs argued that the FDCA did not preempt their claims because the FDA had not affirmatively reviewed and permitted enamel restoration claims.  Id. at *8.  But the plaintiffs had it backward.  According to the court, a state law requirement that diverges from federal law in any way is preempted.  In other words, “state requirements are not permitted unless they are identical to federal standards.”  Id. at **7-8.  The plaintiffs therefore needed to plead facts suggesting that the FDA has affirmatively prohibited the “Restores Enamel” label.  Id. at *8.  “Otherwise, plaintiffs’ state law causes of action would be, in effect, imposing a labeling requirement that is ‘not identical with’ labeling requirements under federal law.”   Id. at **8-9. 

The plaintiffs could not meet that burden because the FDA has not prohibited the “Restores Enamel” label.  To the contrary, the FDA has issued monographs directly on point and has never said that “Restores Enamel” is misleading.  The district court therefore correctly concluded that “if successful, this litigation would do exactly what Congress, in passing [the OTC express preemption provision], sought to forbid:  using state law causes of action to bootstrap labeling requirements that are ‘not identical with’ federal regulation.”  Id. at *9.  We could hardly have said it better ourselves.

Preemption of the state-law claims did not put an end to the entire lawsuit.  Plaintiffs still had their federal claims under the Magnuson-Moss Warranty Act, but the district court was equally direct in disposing of those claims, too.  Under the MMWA, a warranty is a written affirmation that a consumer product will be defect free or meet a specified level of performance “over a specified period of time.”  Id. at **12-13.   Because the “Restores Enamel” claim does not guarantee enamel restoration over any period of time, the statute did not apply.  Id. at *13.  Case closed. 

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Posted By Steven Boranian to Drug and Device Law at 11/14/2014 08:00:00 AM

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