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.
Be that as it may, the oral argument (transcript here) revealed a lot about the true nature of preemption and the Justice’s thoughts.
First, Justice Alito prompted the generic drug company’s lawyer to admit that there would be no “impossibility” preemption under a “pure” Second Restatement strict liability rule (I’ve advocated for pure strict liability here in Pennsylvania):
JUSTICE ALITO: Suppose that New Hampshire had a real strict liability regime, so that you — you sell a drug, and whether it’s unreasonably dangerous or not it causes an injury, you pay, to spread the costs. Would there be a problem with that?
MR. LEFKOWITZ [the appellate lawyer for Mutual Pharmaceuticals: Justice Alito, I think if we had what would really be an absolute liability scheme, I think is really what you are suggesting, something similar to the kind of vaccine compensation program that we heard about this morning, that would not raise impossibility preemption problems at all. It might or might not raise obstacle issues; it would depend perhaps on the scope of the program, whether it was singling out certain types of drugs, how expensive it was; but that would be a very different situation.
Interestingly, both Justice Kagan and Justice Roberts later appeared to agree that the question at the heart of impossibility is whether the State requires something different, not whether the State makes a defendant pay compensation for its actions:
JUSTICE KAGAN: But, Mr. Lefkowitz, I think in describing the FDCA just now, you used the word “authorizes,” and typically, when we think about impossibility, it’s not enough that a State law penalizes what Federal law authorizes. What we — something is impossible when a State law penalizes what Federal law requires or maybe — or, where State law penalizes what Federal law gives you a right to do. But it’s not enough for impossibility that State law penalizes what Federal law permits.
And it seems as though what we have in the FDCA is a statute that authorizes, that says, you can sell this. But it doesn’t say you must sell it, and it doesn’t give you a right to sell it.
CHIEF JUSTICE ROBERTS: … Our cases are focused on the concern that the State is going to impose on the manufacturer a different duty than the Federal government.
That’s not what’s going on in a strict liability regime. They’re saying, we’re not saying you should have a different structure, we’re not saying anything about warning; we’re saying if you do this, you’re going to have to pay for the damage. It’s not - it’s not a different duty. And I think that’s what’s underlying the argument that, well, you can just stop selling, because you don’t have to adjust how you’re going to make the drug. You understand that it’s going to be the same as the Federal drug, but our system is, you pay for the damage.
It’s refreshing to see Justice Alito and Justice Roberts, both of whom were in the majority in PLIVA v. Mensing, recognizing that the word “impossibility” isn’t a magical incantation the defendant can utter and then avoid liability. For “impossibility” preemption to imply, the State needs to pass a law that forces a defendant to do something different from what the federal law requires. It can’t merely be that the State forces the defendant to pay compensation — that’s like saying State-issued speeding tickets make interstate trucking by federally-licensed companies “impossible.”
Of course, no Supreme Court argument would be complete without some input from the resident troll who, by way of the single “question” he asked, advocated forcefully for Judicial Activism by disparaging the merits of trial by jury:
MR. FREDERICK [the appellate lawyer for Karen Bartlett]: What the State law is seeking to do here, Mr. Chief Justice, is to impose liability where there is proof of an unreasonably dangerous product. That unreasonable danger entails evidence of a risk/benefit analysis that looks at the overall risks to the population against the overall benefits that are provided for the drug.
JUSTICE SCALIA: The jury decides all of this, right?
MR. FREDERICK: That’s correct.
JUSTICE SCALIA: That’s wonderful. Twelve — twelve tried men and few — and true [who?] decide for the whole State what the — what the cost/benefit analysis is for a very novel drug that unquestionably has some deleterious effects, but also can save some lives.
And the jury’s going to decide that?
MR. FREDERICK: Yes, it is.
I know Justice Scalia has been busy writing books about how to read laws, but, given his sarcastic remarks about the utility of juries, perhaps he would do well to re-read this sentence:
In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury, shall be otherwise re-examined in any Court of the United States, than according to the rules of the common law.
It’s been in the Constitution for a while now.