We recently examined one possible beneficial impact of the Supreme Court’s recent landmark decision in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024) – that it could bring about critical re-examination of the FDA’s questionably supported ban on truthful off-label speech.
Well here’s another one: Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).
We’ve already detailed a number of ways in which Lohr is of questionable validity: (1) it relied on a presumption against preemption that has since been repudiated; (2) it addressed an anachronistic form of device clearance that no longer exists; (3) Congress revamped device clearance in 1990 to provide preemptive “reasonable assurance” of “safety”-based special controls; and (4) Justice Gorsuch had written an opinion questioning Lohr before he was elevated to the Supreme Court.
To that we can now add Loper Bright. To satisfy not-so-idle curiosity, we recently searched Supreme Court opinions for references to Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), the decision that Loper Bright expressly overruled.
And there it was in Lohr – cited no fewer than four times.
Lohr, as we’ve discussed before, created an extra-statutory “device specificity” requirement that appears nowhere in the relevant preemption clause. 21 U.S.C. §360k(a). It also invented the so-called “parallel claims” exception to preemption, also without any express statutory support. The majority relied on the FDA’s regulatory interpretation of the FDCA (in addition to the now-rejected presumption against preemption) in recognizing these restrictions on express preemption of medical device tort claims.
As to parallel claims, the Lohr majority found that “[t]he FDA regulations interpreting the scope of §360k’s pre-emptive effect support [plaintiffs’] view, and our interpretation of the pre-emption statute is substantially informed by those regulations.” 518 U.S. at 495 (emphasis added).
Congress has given the FDA a unique role in determining the scope of § 360k’s pre-emptive effect. . . . Because the FDA is the federal agency to which Congress has delegated its authority to implement the provisions of the Act, the agency is uniquely qualified to determine whether a particular form of state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress,” and, therefore, whether it should be pre-empted. . . . The ambiguity in the statute − and the congressional grant of authority to the agency on the matter contained within it − provide a “sound basis,” for giving substantial weight to the agency’s view of the statute.
Id. at 495-96 (citing Chevron). Thus, Lohr held, “regulations promulgated by the FDA expressly support the conclusion that §360k ‘does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act.’” 518 U.S. at 496-97 (quoting 21 CFR § 808.1(d)(2)).
Lohr also relied on “the critical importance of device specificity in our (and the FDA’s) construction of §360k.” 518 U.S. at 502. The majority found the plaintiffs’ argument that “§360k(a) mandates pre-emption only where there is a conflict between a specific state requirement and a federal requirement ‘applicable to’ the same device” was “supported by the FDA regulations, which provide that state requirements are pre-empted “only” when the FDA has established ‘specific counterpart regulations or … other specific requirements applicable to a particular device.’” Id. at 498 (again quoting §808.1(d)). Rotely following the FDA-added limitations on preemption Lohr stated:
[T]he regulations provide that state requirements of “general applicability” are not pre-empted except where they have “the effect of establishing a substantive requirement for a specific device.” Moreover, federal requirements must be “applicable to the device” in question, and, according to the regulations, pre-empt state law only if they are “specific counterpart regulations” or “specific” to a “particular device.” The statute and regulations, therefore, require a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement to determine whether they fall within the intended pre-emptive scope of the statute and regulations.
Id. at 500 (again quoting §808.1(d)).
Chevron is cited again in Justice Breyer’s concurring opinion in Lohr – also to justify using the FDA’s regulatory gloss to narrow the express terms of the FDCA’s device preemption provision:
[T]his Court has previously suggested that, in the absence of a clear congressional command as to pre-emption, courts may infer that the relevant administrative agency possesses a degree of leeway to determine which rules, regulations, or other administrative actions will have pre-emptive effect.
Lohr, 518 U.S. at 505-06 (citing, inter alia, Chevron, 467 U.S. at 842-45).
The dissent in Lohr also had plenty to say about Chevron deference – and how it shouldn’t apply at all:
The Court holds that an FDCA “requirement” triggers pre-emption only when a conflict exists between a specific state requirement and a specific FDCA requirement applicable to the particular device. The plurality emphasizes the “critical importance of device specificity” in its understanding of the pre-emption scheme. To reach its particularized reading of the statute, the Court imports the interpretation put forth by the FDA’s regulations. . . . Apparently recognizing that Chevron deference is unwarranted here, the Court does not admit to deferring to these regulations, but merely permits them to “infor[m]” the Court’s interpretation. It is not certain that an agency regulation determining the pre-emptive effect of any federal statute is entitled to deference, but one pertaining to the clear statute at issue here is surely not. . . . Where the language of the statute is clear, resort to the agency’s interpretation is improper. See Chevron [citation omitted]. . . . [T]he term “requirement” encompasses state common-law causes of action. The Court errs when it employs an agency’s narrowing construction of a statute where no such deference is warranted. The statute makes no mention of a requirement of specificity, and there is no sound basis for determining that such a restriction on “any requirement” exists.
Lohr, 518 U.S. at 511-12 (citations and quotation marks omitted).
Well, Chevron is no more. Further, a majority of the Court has since sided with the Lohr dissent on the FDA lacking the power to define the scope of FDCA preemption. See PLIVA, Inc. v. Mensing, 564 U.S. 604, 613 n.3 (2011) (“[W]e do not defer to an agency’s ultimate conclusion about whether state law should be pre-empted.”); Wyeth v. Levine, 555 U.S. 555, 576-77 (2009) (“we have not deferred to an agency’s conclusion that state law is pre-empted” because “agencies have no special authority to pronounce on pre-emption absent delegation by Congress”).
The demise of Chevron deference thus – independently of all of Lohr’s other flaws – calls into question the entire anti-preemption edifice that courts have constructed from its twin holdings that invented both “parallel claims” and “device-specific” limits on medical device preemption. Loper Bright reads much more like the Lohr dissent, than it compares to either the majority or concurring opinions in Lohr. Loper Bright essentially tells courts to ignore administrative interpretations and to give statutes “the reading the court would have reached if no agency were involved,” 144 S.Ct. at 2266 (citation and quotation marks omitted). “[T]he interpretation of the meaning of statutes, as applied to justiciable controversies, [i]s exclusively a judicial function.” Id. at 2258 (citation and quotation marks omitted). “[A]gency interpretations of statutes − like agency interpretations of the Constitution [which is what preemption is] − are not entitled to deference.” Id. at 2261 (emphasis original).
In an agency case as in any other, though, even if some judges might (or might not) consider the statute ambiguous, there is a best reading all the same − the reading the court would have reached if no agency were involved. It therefore makes no sense to speak of a “permissible” interpretation that is not the one the court, after applying all relevant interpretive tools, concludes is best. In the business of statutory interpretation, if it is not the best, it is not permissible.
Id. at 2266 (citation and quotation marks omitted).
Obviously, we don’t think that either of the two atextual glosses that Lohr created to cabin the otherwise broad language Congress used in §360k(a) is the “best” reading of the FDCA. We thus urge defendants, post-Loper Bright, to consider taking on frontally these invented limitations on express preemption . Pick your spots, of course, but be prepared to lose in courts that still wrongly consider themselves bound by Lohr. Preserve the issue for appeal. When it eventually reaches the United States Supreme Court, and it should, we have a good chance of prevailing.
It’s time.