Preemption And OTC Drugs

• Jurisdiction: United States,Federal,California
• Law Firm: Reed Smith
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Food and Drugs Law, Biotechnology & Nanotechnology
• Author: Ms Lisa Baird
• Published date: 27 September 2023

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...