We’ve re-read Monsanto Co. v. Durnell, No. 24-1068, 609 U.S. ___, 2026 LX 336645, 2026 WL 1825691 (June 25, 2026) (“Durnell”), a few times over the past few weeks. As Bexis noted in his quick-out-of-the gate (and great) analysis, there is a lot in there to use in our medical device preemption cases.
The point is, just because Durnell involved Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) preemption, please don’t just skim it and move on.
The primary reason why it deserves a spot in your regular preemption authorities rotation is because it extensively and directly relied on Riegel, and it had a lot of good things to say about the meaning of Riegel that will run counter to many arguments you see from the other side of the “v”.
As the Supreme Court said, Riegel was instructive to its analysis in Durnell, a FIFRA preemption case, because “[i]n Riegel, the Court addressed the preemption clause in the Medical Device Amendments of 1976, which is nearly identical to FIFRA’s preemption clause.” Durnell, 2026 U.S. LEXIS 2721 at *20 (emphasis added). In addition: Both the FDA (for medical devices and OTC drugs) and the EPA (for pesticides) analyze the safety of their regulated products before they can grant approval; both must ensure product labels are “neither false nor misleading”; and after approval, “the manufacturer is required to use that label and is prohibited from making any changes to the device or label” without additional federal approval. Id.
For our purposes, just as the similarities between the express preemption clauses in the Medical Device Amendments and FIFRA made Riegel “dispositive” of the FIFRA preemption issue in Durnell, the similarities between the two should also make the holding in Durnell dispositive of Durnell-type arguments in your Medical Device Amendment express preemption matters. See id. at *21 (Supreme Court recognizing that its Durnell “affects more that FIFRA” and applies to cases involving similar preemption provisions, like 21 U.S.C. 360k(a)).
Again: Don’t let good Supreme Court precedent go to waste!
A Durnell Recap
In Durnell, the plaintiff contended that even though the EPA had approved a pesticide’s label without a cancer warning, the manufacturer should have given a cancer warning, and was liable under state tort law for not doing so. Id. at *6.
The Supreme Court readily found that claim preempted, because that “state tort claim would require [the manufacturer] to add a cancer warning to [the pesticide’s] label even though federal law require[d] [the manufacturer] to use the EPA-approved label without a cancer warning.” Id. at *6-*7, *14-*15. Thus, the state law requirement was “in addition to” and “different from” the manufacturer’s federal-law labeling obligations, and preempted. Id. at *18.
The Supreme Court also shot down three arguments raised by the Durnell plaintiff in trying to avoid preemption.
First, the Durnell plaintiff argued that preemption did not apply because state and federal law were consistent—basically, that Plaintiff’s state law failure-to-warn claim and a “misbranding” provision in FIFRA both require “adequate warnings” that are not “false or misleading.” Id. at *15, *22.
That argument failed because it “operate[d] at far too high a level of generality.”
Looking at only FIFRA’s general standard for misbranding rather than the specific requirements imposed under federal law would nullify FIFRA’s preemption clause and the uniformity that Congress sought for safety warnings on pesticide labels.
Id. at *22.
Although the majority did not explicitly discuss whether or how to state a parallel claim that survives preemption (and the dissent said Riegel never addressed this issue at all, id. at n.9 (Jackson, J. dissenting)), this “misbranding is too general” point is interesting. It suggests that there must be a good amount of equivalence between the duty under federal law and the duty under state law. See, e.g., Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1300 (11th Cir. 2011) (genuinely equivalent); Otis-Wisher v. Medtronic, Inc., 616 F. App’x 433, 434 (2d Cir. 2015) (identical).
In any event—and this is key—regardless of what warnings the Durnell plaintiff believed should have been given over time, different or additional warnings flew in the face of the specific labeling requirements that the EPA actually had imposed in reviewing and approving specific label language. Id. at *22.
Second, the Durnell plaintiff suggested that “the EPA-approved and EPA-required label” had “become misbranded over time due to new evidence.” In essence, they argued that post-approval events had overtaken the EPA’s initial label approval, with new information rendering that label inadequate over time. Id. at *25-28. That argument also failed.
Allowing a post-approval failure-to-warn claim as plaintiff suggested “would negate FIFRA’s express preemption clause, expose manufacturers to potentially massive tort liability for doing what EPA required them to do, and eviscerate the ‘uniformity’ of EPA’s labeling determinations.” Id. at *28.
Simply put, the plaintiff’s allegations about new information did not deprive the EPA’s original warning label determinations “of their preemptive force.” Id. at *29.
Durnell also recognized that such arguments also “contravene” the Supreme Court’s Riegel decision.
Similar to the EPA’s powers under FIFRA, the FDA is authorized to “withdraw premarket approval for a medical device based on ‘newly reported data or existing information’” and is required to do so if it newly determines the device is unsafe in ineffective. Id. at *28-29 (quoting Riegel, 552 U.S. at 319). Despite that federal power to reassess new data and to change its approval decision, the Supreme Court in Riegel still concluded that the in-effect premarket approval imposed federal requirements that preempted state tort suits. Id. at *29 (citing Riegel, 552 U.S. at 322-23).
A third, and related, argument was one of policy. The Durnell plaintiff suggested that the regulatory response would inevitably lag the development of post-approval safety information and thus federal regulation and preemption should step aside and allow that gap to be addressed through plaintiff-driven state tort lawsuits. Id. at *30.
The Supreme Court was not swayed. Not only did its textual analysis of “in addition to” and “different from” express preemption provisions preclude such claims [id. at *18], imposing liability also was unnecessary given regulatory authority. Similar to what is required of medical device manufacturers, FIFRA requires manufacturers to “apprise EPA of new information ‘regarding unreasonable adverse effects’ of their pesticides”; it allows the EPA to require more information, conduct new scientific analyses, and review third party petitions to modify or cancel a pesticide’s approval”; and it has other mechanisms for outsiders to bring new safety information to the regulator’s attention as well. Id. at *30-31.
In other words, the “comprehensive regulatory regime” provides EPA with “a variety of tools to learn of and address new safety information” but in an event, “as a matter of law, state tort law may not impose labeling requirements ‘in addition to’ or ‘different from’ federal requirements imposed under FIFRA.” Id. at *31.
Using Durnell In Medical Device Preemption Cases
The Supreme Court itself said that Riegel controlled Durnell, and that Durnell would affect more than FIFRA cases, so there is no mystery about whether Durnell matters to the issues in our sandbox. It does; the Court itself says so.
But more than that, doesn’t Durnell actually wipe out a lot of the parallel-claim nonsense in the medical device sphere?
Think about Bausch v. Stryker Corp., 630 F.3d 546, 554-55 (7th Cir. 2010), in which the Seventh Circuit rejected the defense arguments that Quality System Regulations (QSRs) and CGMPs are “too general to allow juries to enforce them.” But Durnell just said that “misbranding” operated at “far too high a level of generality,” and we would argue that Durnell‘s conclusion carries through to QSRs and CGMPs as well.
Think also about Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013). Wasn’t that a Durnell-style post-sale duty to warn claim?
In particular, the Stengel plaintiff’s contention, as proposed in an amended complaint, was that the device manufacturer had a federal law “continuing duty to monitor the product after pre-market approval” and a failure to comply with that federal duty breached the “duty to use reasonable care” under Arizona negligence law. Id. at 1232. Sorry, but that is a lot of “too high a level of generality” on both the federal requirement side and the state requirement side.
Then there is Stengel’s stated rationale for finding plaintiff’s claim not preempted: “Arizona state law has long been concerned with the protection of consumers from harm caused by manufacturers’ unreasonable behavior.” Id. at 1233.
Durnell shut that down, recognizing that the regulatory authority afforded the EPA under FIFRA was more than well-equipped to address safety concerns—and if anything, the FDA’s regulatory powers are even greater where PMA medical devices are concerned.
Of course, the Stengel majority also stepped in to re-work the plaintiff’s claim by purporting to identify a more “precise parallel”—namely the federal requirement to report adverse events to the FDA and a state-law duty to warn. See id. at 1233.
Judge Watford, in his concurrence, recognized that this gloss meant the plaintiff would “ultimately have to prove that” the new and different information—not included in the federally-required warning label—would have had to reach Mr. Stengel’s doctors, and resulted in a different medical treatment decision that would have prevent his injuries.
Setting apart the other reasons why Stengel is nonsense (see, e.g., here and here), doesn’t this run squarely into the most fundamental point in Durnell? Durnell looked past all the arguments about new and different information developed post-approval, and recognized this one fundamental truth: A different warning is a different warning is a different warning.
If the federal regulator didn’t require that warning to be given, then state law cannot require otherwise, full stop.
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