Express Preemption Based On Forceful Agency Action Pursuant To Law

• Published date: 17 July 2023
• Subject Matter: Consumer Protection, Litigation, Mediation & Arbitration, Food, Drugs, Healthcare, Life Sciences, Product Liability & Safety, Trials & Appeals & Compensation, Food and Drugs Law, Biotechnology & Nanotechnology
• Law Firm: Reed Smith
• Author: Mr Eric Alexander

When we have given talks on preemption, whether to law firm personnel, attendees of professional conferences, or new FDA employees, we have tended to start with the Supremacy Clause and then break up the types of preemption and the issues related to them into different buckets. We have not had to name those buckets or make tough calls about what issues go into which buckets because the categories have been pretty clear for a long time. There is express preemption, which exists when there is a preemption provision in the federal law. Those provisions often flag state requirements that are "in addition to or different from" the federal requirements. There is also implied preemption, which breaks up into field preemption and conflict preemption'which itself breaks up into "impossibility" preemption and "purposes and objectives" preemption. Riegel and Lohr are express preemption cases and Buckman, Levine, and Albrecht are implied preemption cases. The interplay of express and implied preemption in product liability litigation over PMA devices has led to the invention of the near-mythical "parallel claim" monster. We have suffered not so silently countless times when we have seen courts' confusion over the types of preemption lead to gaffes like applying a presumption against preemption where it does not belong.

This dynamic is not limited to drug and device litigation and the FDCA. There has been plenty of litigation involving pesticides and FIFRA, and it has produced a bunch of preemption decisions. The most famous of these is probably Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), which involved an herbicide'FIFRA treats weeds as pests. While we do not purport to be FIFRA experts, we have written a number of times about the preemption issues posed by the express preemption clause in FIFRA, which mirrors the one in the FDCA for PMA devices. Over the last few years, litigation over glyphosate-containing products and whether they cause cancer has been almost inescapable. At least the lawyer advertising has been. And it had not escaped our attention, either. In 2019, we noted the clear rejection by EPA'which is responsible for enforcing FIFRA'of a link between glyphosate and cancer and wondered what effect it would have on litigation. Over the next two years, we reported on an intermediate California appellate court decision and a Ninth Circuit decision that went plaintiffs' way on the lack of preemption, despite EPA's position. Part of what carried the...