This week’s U.S. Supreme Court argument in Bartlett v. Mutual Pharmaceutical (link goes to my thoughts on the case, which I posted back in December) has taken the issue of “impossibility preemption” for a brief stroll through the rest of the legal world, crossing paths with some major news outlets. Karen Bartlett was given a shot of a pain reliever, sulindac, which caused her to develop Stevens-Johnson Syndrome and toxic epidermal necrolysis so severe her burn surgeon called it “hell on earth.” There would be a handful of legal avenues available to her if she had received the brand-name drug, but, because she received a generic, there’s the looming question as to whether her State tort law lawsuit is “preempted” under the Supreme Court’s 2011 case, PLIVA v. Mensing.
A brief refresher. There are four types of “preemption,” so named when federal law trumps — i.e., “preempts” — state law.
1. Express Preemption is when Congress and the President pass a law that says States’ law on the issue are unenforceable. For example, the preemption clause of ERISA, 29 U.S.C. § 1144, “the provisions of this title … shall supersede any and all State laws insofar as they may now or hereafter relate to any employee benefit plan …”
2. Impossibility Preemption is when Congress has not passed any law preempting State law, but “where compliance with both federal and state regulations is a physical impossibility for one engaged in interstate commerce.” Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143 (1963).
3. Conflict Preemption occurs where Congress hasn’t passed a law preempting State law, and where it’s possible to comply with both, but “under the circumstances of [a] particular case, [state] law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Hines v. Davidowitz, 312 U.S. 52, 67 (1941).
4. Judicial Activism Preemption happens when a judge, or the majority of judges on a federal appellate court, don’t like a particular State law and so make up a reason to get rid of it. No, the courts themselves don’t call it that, they typically call it “impossibility preemption.” This is my term for it.
In the Bartlett case, just like in every other pharmaceutical liability case, there’s no express preemption. In the 80 years since the passage of the Federal Food, Drug, and Cosmetic Act in 1938, Congress has never once saw fit to preempt State law lawsuits against brand-name or generic drug manufacturers.
In 2011, a slim majority of the Supreme Court in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) applied what I call Judicial Activism Preemption under the guise of impossibility preemption, and made up a reason to blow up the majority of lawsuits against generic drug manufacturers. I wrote more about it here. Law professor Leslie Kendrick recently wrote about how problematic impossibility preemption is in the conduct of pharmaceuticals in general.
Mensing involved a “failure to warn” claim — i.e., an allegation that the drug’s warning labels didn’t adequately disclose the drug’s real risks — and the Supreme Court held those claims were preempted. Bartlett on the surface involves a pure strict liability claim — i.e., a claim that the drug is simply unreasonably dangerous given the minor benefits it has compared to the serious risks — and then in the details involves a number of complicated factual and legal issues, including the strange decision by the defendant to waive most of its defenses, complicated issues that, to me, should have caused the Supreme Court to decline the case for consideration.