United States: Don't Forget About OTC Express Preemption

Last Updated: September 25 2019
Article by Steven Boranian

Did you remember that there can be express preemption for over-the-counter drugs? We sometimes forget too, but there are really good reasons for that. The Food Drug and Cosmetic Act includes the following provision:

[N]o State or political subdivision of a State may establish or continue in effect any requirement – (1) that relates to the regulation of [a non-prescription, over-the-counter drug]; and (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under [the FDCA] . . . .

21 U.S.C. § 379r(a). This sounds pretty good, especially the "otherwise not identical" part, which is about as good as express preemption clauses get. So why do we not see more express preemption in OTC cases?

For one thing, there is a significant exception in the form of a savings clause: "Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State." 21 U.S.C. § 379r(e). That's right, there is no express preemption for OTC drugs in product liability lawsuits, which is a pretty big part of what we do. That is the first reason we don't see much of it.

Another reason is that the sources of federal requirements for OTC products under the FDCA are not consistently strong and clear. Sure, there are OTC drugs that undergo the rigorous New Drug Application process, but many OTC drugs are marketed under monographs, some of which are decades old. We have long wondered whether such federal requirements are "requirements" sufficient to carry the preemption day. (You can see some of our prior posts on OTC express preemption with clever titles like "Express Preemption OTC" and "Preemption Without Prescription" here and here)

Take for example Bailey v. Rite Aid Corp., No. 18-CV-06926, 2019 Dist. LEXIS 153498 (N.D. Cal. Sept. 9, 2019). In Bailey, the plaintiff purchased "rapid release" acetaminophen gelcaps from a retail pharmacy and sued under California's consumer protection laws because the "rapid release" version worked no better or faster than cheaper, regular acetaminophen tablets. Id. at *3-*4. According to the plaintiff, he and a class of "rapid release" acetaminophen gelcap purchasers paid too much, even though it was undisputed that the seller never claimed that the product provided faster pain relief.

The defendant moved to dismiss on multiple grounds, but the takeaway for us is on preemption. The case brought consumer fraud claims, so the exception for product liability lawsuits did not apply. How about the whether the lawsuit was establishing a state requirement that was "not identical" to federal requirements? That is where the preemption defense ultimately fell short. The defendant offered two sources for federal requirements—a tentative final monograph issued by the FDA in 1988 and two FDA guidance documents covering dissolution testing and "immediate release" products. Id. at *9-*10.

Neither of these documents preempted the plaintiff's claims. The district court found that the 1988 tentative final monograph had the force and effect of a final monograph, even though it was not actually final. Id. at *10. However, while the 1988 monograph and related documents covered dissolution standards for "immediate release" drugs, they did not cover similar standards for "rapid release" drugs. Id. at *12-*14. That seems like a pretty thin distinction to us, but it was enough for the district court to find that the plaintiff's state requirements were "not identical" to federal requirements. As for the two guidance documents, the district court pretty much gave them the back of the hand. Even though it was uncontested that the product met standards set forth in the guidance documents, the district court found "that the FDA Guidance does not constitute a requirement under the FDCA within the meaning of Section 379r(a)." Id. at *13-*14. The district court noted that the document is "covered with disclosures warning that the document is non-binding," which was enough to deprive it of preemptive effect. Id. at *14. We will remember that the next time someone tries to enforce a "non-binding" guidance document against us in the future.

Express preemption did not work in this OTC case, but we would not give up on it. The only class actions we continue to see in the drug and medical device space are brought under consumer protection statutes—cases like Bailey seeking the refund of part or all of a product's purchase price. Those kinds of lawsuits typically will not fall with the "product liability law" exception, leaving OTC express preemption in the defense toolbox. Moreover, the district court ruled in Bailey that a 30-year-old tentative final monograph was sufficient to erect federal requirements, even if those requirements were not quite close enough to preempt this particular plaintiff's claims. That's encouraging.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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