It is fair to say that Bexis co-founded this blog (in 2006!) in part to aid the cause of medical device and pharmaceutical manufacturers, targets in our lawsuit-obsessed country. Over the years, this blog has come to serve as an important resource for our drug and defense bar colleagues, and Bexis regularly identifies—if not invents—new legal issues and ideas, then proselytizes about them until they become part of the fabric of our legal lives.
For example, your humble bloggers spend a lot of time thinking about federal preemption, the other side’s never-ending efforts to get around it, and how defense lawyers should respond. It is quite possible that preemption thoughts invade our daily commutes, our reverie over morning coffee, and (embarrassingly) what we think passes for amusing cocktail party repartee. Can you blame us? This is good stuff! Federal preemption is based in the U.S. Constitution’s Supremacy Clause, it strikes a balance between state and federal power on issues of public health and safety, and raises questions about whether our country’s approach to regulation and litigation makes sense for pharmaceuticals and medical devices (spoiler alert: it doesn’t).
Federal preemption involving OTC drugs is the subject of today’s musings. As a reminder, the OTC express preemption provision states in relevant part that:
[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 drug that is not subject to the requirements of [prescription drugs] of this title; and
(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter. . . .
21 U.S.C. § 379r(a)(1). The “state law requirement” reference includes, but is not limited to, warning-based claims:
a requirement that relates to the regulation of a drug shall be deemed to include any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug.
21 U.S.C. § 379r(c)(2).
Of course, the OTC express preemption provision has a carve-out for personal injury cases, 21 U.S.C. § 379r(e), which provides that “[n]othing 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.” So, if a plaintiff’s lawsuit involves an OTC drug and falls into the “product liability” bucket, it is not preempted by 21 U.S.C. § 379r (but sometimes, implied preemption arguments may still work). If the lawsuit falls into any other bucket—such as economic loss claims—it is preempted.
An older case, Carter v. Novartis Cons. Health, Inc., 582 F. Supp. 2d 1271 (C.D. Cal. 2008), shows how the OTC express preemption provision should work. Carter involved four lawsuits alleging the defendants’ cough and cold medicines (including those with phenylephrine) “do not work” and were “dangerous to children under the age of six.” Id. at 1276.
As Carter recounts, starting in 1976, FDA developed the OTC Cough and Cold Monograph, 21 C.F.R. part 341, which provides “approved indications for use and age-dependent dosage instructions.” Id. at 1276. Compliant drugs are GRASE—generally recognized as safe and effective. See 21 C.F.R. § 341.1. As Carter recognized, these are “federal requirements” for express preemption purposes.
Next, addressing 21 C.F.R. § 379r right after the U.S. Supreme Court decided the express medical device preemption case of Riegel v. Medtronic, 552 U.S. 312 (2008), and considering 21 U.S.C. § 379r(c)(2), Carter also quickly recognized that the OTC preemption “state requirement” prong includes state law causes of action, not just state legislation or regulations. Id. at 1281-82.
Finally, the court compared the state and federal requirements, and rejected the idea that a supposed generalized state law “duty not to deceive” survived preemption, rejected the idea that express and implied warranties fall outside of preemption—even if they duplicate FDA-approved statement—because they are voluntary obligations assumed by the defendant, and recognized that claims seeking economic damages do not fall within the 21 C.F.R. § 379r(e) product liability savings clause Id. at 1283-87.
Contrast Carter’s swift disposal of the idea that state law claims involving deception survive preemption with the cases discussed in a post by Bexis last month—cases that seem to go out of their way to misunderstand 21 U.S.C. § 379r(a)(1)’s express preemption provision if a claim asserts that an OTC drug label is false or misleading.
For example, relying on a cosmetics case (Astiana v. Hain Celestial Group., Inc., 783 F.3d 753, 758 (9th Cir. 2015)), Booker v. E.T. Browne Drug Co., 2021 WL 4340489 (S.D.N.Y. Sept. 23, 2021), decided that OTC preemption did not matter where the plaintiff alleged the drug label was false at a high level of generality:
A drug is misbranded under the FDCA when “its labeling is false or misleading in any particular.” 21 U.S.C. §352(a)(1). Consequently, it appears that Plaintiffs’ grievances − i.e., that the Products do not prevent or reduce [what they claimed], despite the claims on their labels − fall squarely within the realm of conduct that would violate the FDCA. . . . [P]laintiffs’ claims would not be different from obligations imposed under the FDCA because they would simply require Defendant to truthfully state efficacy or not sell its products.
Booker, 2021 WL 4340489 at *7.
Bexis’s post dissects the errors in these OTC preemption cases and the Astiana cosmetics case they rely on, provides guidance about pushing back on zombie arguments like the presumption against preemption, and cautions against importing the “parallel claim” concept from the medical device preemption context into preemption under 21 C.F.R. § 379r.
But here are some further thoughts. The first has to do with the idea that the plaintiff in a civil lawsuit can use state law to declare a drug misbranded. That is the FDA’s job:
An over-the-counter (OTC) drug …. is not misbranded if it meets each of the conditions contained in this part and each of the conditions contained in any applicable monograph. Any product which fails to conform to each of the conditions contained in this part and in an applicable monograph is liable to regulatory action.
21 C.F.R. §330.1 (emphasis added). In fact, 21 U.S.C. § 337(a) also tells us that the United States the sole authority to police alleged violations of the FDCA. It provides:
[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.
If that weren’t enough, Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), recognized that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § 337(a). So, even setting aside 21 U.S.C. § 379r for a moment, “it is false so it also is ‘misbranded’” claims can be impliedly preempted even if they are not expressly preempted. See Buckman, 531 U.S. at 352 (citing Geier v. American Honda Motor Co., 529 U.S. 861 (2000)).
The second is that OTC monographs impose federal requirements—including labeling requirements—on the drugs they cover, and manufacturers are not free to unilaterally change them. As a result, implied preemption derived from PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) is worth consideration as well. For a fuller explanation of that, the blog also has you covered.
Finally, getting back to express preemption, the whole, very general “false under state law is the same as misbranded under federal law” notion just doesn’t hold water. As noted, the FDA’s determination that an OTC drug “is not misbranded” per 21 C.F.R. §330.1 if it complies with monograph labeling is a determination that the label is not false or misleading. Challenging OTC monograph-compliant label statements as false under state law quite simply is an attempt to impose a state law requirement “that is different from or in addition to, or that is otherwise not identical with” the federal requirement, and preemption results.