In our 2017 post, “Medtronic v. Lohr Has Two Shadows,” we pointed out that the “presumption against preemption” that was the linchpin of that decision’s limited and atextual reading of the FDCA’s express preemption clause for medical devices, 21 U.S.C. §360k(a), was no more. Lohr had justified its specificity gloss on the broad statutory term “requirement” by relying on that presumption:
In all pre-emption cases, and particularly in those in which Congress has legislated in a field which the States have traditionally occupied, . . . we use a “presumption against the pre-emption of state police power regulations” to support a narrow interpretation of such an express command.
518 U.S. 470, 485 (1996).
In Two Shadows, we pointed out that this presumption has since been abolished, in express preemption cases, by Puerto Rico v. Franklin California Tax-Free Trust, 579 U.S. 115 (2016) (“Franklin”).
The plain text of the [preemption clause] begins and ends our analysis. . . . And because the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.
Id. at 125.
Without that presumption, we argued, Lohr had no basis for holding that Congress had meant anything less than it had said in §360k(a). Or, as the Supreme Court held more recently, in a non-preemption context, “[w]hen the express terms of a statute give us one answer and extratextual considerations suggest another, it’s no contest. Only the written word is the law, and all persons are entitled to its benefit.” Bostock v. Clayton County, Georgia, 140 S. Ct. 1731, 1737 (2020).
Yet, after Franklin, courts seemed very slow in applying the abolition of the presumption against preemption to Lohr itself.
We recently hammered the Eighth Circuit when we thought it was wrong about Fed. R. Evid. 702 in a non-prescription medical product case. Thus, it’s only fair that we hail that same court when it gets something right. Thus, we’re pleased to bring to your attention Pharmaceutical Care Management Association v. Wehbi, 18 F.4th 956 (8th Cir. 2021) (“PCMA”), the first decision to recognize expressly what we thought was obvious in Two Shadows – that Franklin overruled Lohr as to the presumption against preemption in the context of express preemption.
PCMA involved something altogether outside our sandbox – express preemption under ERISA and/or the 2003 statute that created “Medicare Part D.” Id. at 964. While the substantive effect of such preemption is important to a lot of folks (the case attracted nine amici curiae briefs on behalf of literally scores of amicus parties), that’s not our interest on this Blog. We’re interested in the presumption against preemption – particularly as Lohr applied it.
In PCMA “the parties dispute whether we should invoke a presumption against preemption in this case given that both ERISA and Medicare Part D feature express preemption provisions.” 18 F.4th at 967. One side – the defendants – “rel[ied] on a line of Supreme Court cases invoking a presumption against preemption in the face of an express preemption provision,” id., specifically Lohr and New York State Conference of Blue Cross & Blue Shield Plans v. Travelers Insurance, 514 U.S. 645, 654-55 (1995). Long-time Blog readers may recognize both of these decisions from our first-ever blogpost on the presumption against preemption some fifteen years ago.
The other side in PCMA – the plaintiff – argued that “the [Supreme] Court overruled these cases in [Franklin], where it stated that “because [that statute] contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause.” 18 F.4th at 967.
PCMA expressly “agree[d] with” the plaintiff that Franklin had overruled Lohr (and the other case) specifically on the presumption against preemption. Id.
The defendants argue that because Franklin did not expressly overrule prior precedent, we should not extend it to express preemption provisions such as ERISA’s that the Court has historically treated as subject to a presumption against preemption. But . . . we [have] extended Franklin to the express preemption provision in [the Federal Aviation Act], despite indications that prior to Franklin the Court treated [the FAA’s preemption provision] as subject to a presumption against preemption. So too here, we will follow Franklin and invoke no presumption against preemption when applying the express preemption provisions in ERISA and Medicare Part D.
18 F.4th at 967 (citations omitted). PCMA specifically rejected the plaintiff’s argument that “ that the court should “leav[e] to [the Supreme] Court the prerogative of overruling its own decisions” because it had already done so. Id. (quoting Rodriguez de Quijas v. Shearson/American Express, Inc., 490 U.S. 477, 484 (1989)). PCMA thus becomes the first published court of appeals decision to recognize (to use a non-Dr. Who idiom) that Franklin turned Lohr into the emperor that now wears no clothes.
We applaud the Eighth Circuit for repudiating jurisprudential flabbiness of the sort we decried in Shuker v. Smith & Nephew, PLC, 885 F.3d 760 (3d Cir. 2018), where the Third Circuit – buying the same “prerogative of overruling its own decisions” argument – would not admit that Franklin had tossed Lohr’s presumption against preemption analysis into the dustbin of history. Id. at 782 n.9 (refusing to abandon the presumption until the Supreme Court repeated itself in a “product liability” case involving “the historic police powers of the States”).
As we discussed at length back in 2006, the Supreme Court never applied the supposed “presumption against preemption” in any sort of principled manner. Thus, the Court rightly abolished it for express preemption cases in Franklin. We believe that the Court implicitly did the same thing for implied preemption cases by omitting any reference to such a “presumption” in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), but that’s a topic for another post.