Ever since we reviewed the Environmental Protection Administration’s (“EPA”) 2019 decision reaffirming its prior conclusion that glyphosate does not cause cancer and, therefore, the “Roundup” herbicide did not warrant any cancer warnings, we have been convinced that state-law claims demanding such warnings were (or should be) preempted – regardless of how pro-plaintiff decisions might seek to muddy the waters.
It took a while, but yesterday the United States Supreme Court, in a strong 7-2 decision held precisely that:
[Plaintiff’s] state tort claim would require [defendant] to add a cancer warning to Roundup’s label even though federal law requires [defendant] to use the EPA-approved label without a cancer warning. Because [plaintiff]’s state tort claim would impose a pesticide labeling requirement “in addition to or different from” the label required by EPA, FIFRA expressly preempts [plaintiff]’s claim.
Monsanto Co. v. Durnell, 609 U.S. ___, 2026 WL 1825691, at *3 (slip op.) (U.S. June 25, 2026) (emphasis added) (hereafter “Durnell”).
We add “emphasis” to the statutory language because, as the Supreme Court observed, the express preemption clause that Congress enacted in FIFRA, 7 U. S. C. §136v(b), is “materially identical” to the FDCA’s preemption clause for medical devices, 21 U.S.C. §360k(a). Durnell, 2026 WL 1825691, at *10. See Id. at *8 (“nearly identical”); cf. id. at *8 (listing 21 U. S. C. §§678 (meat); 1052(b) (eggs); 467e (poultry); 379s(a) (cosmetics), 379r(a)(2) (OTC drugs); and 343-1(a)(2)-(4) (food)) as having “similar or identical labeling preemption provisions”). The only difference from §360k(a) is inversion of the order of the phrases “different from” and “in addition to.” The ordering of this identical language meant nothing in Durnell. Thus, the numerous pro-preemption holdings in Durnell should apply with equal force to medical devices and other federally regulated consumables. It becomes our job as defense counsel to ensure that this happens.
Turning to those pro-preemption holdings, we first address something that’s not found in the majority opinion at all – that is any reference to a “presumption,” or even an “assumption” against preemption. That’s important because a 20+-year-old FIFRA opinion, Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005), had relied on such a presumption, despite the statute’s express preemption clause. Id. at 449-50. In the interim (as the Blog has repeatedly discussed), the Court abolished any such presumption in express preemption cases. Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115, 125 (2016). But in Durnell, despite what Bates had held about preemption presumptions, the majority opinion said not a word about it, even while discussing Bates itself. Instead, the “textual conclusion” in Durnell gave force to the literal meaning of §136v(b)’s language:
In sum, federal law requires [defendant] to sell Roundup with the label that EPA approved at the initial registration and that EPA has subsequently re-approved on multiple occasions − that is, the label without a cancer warning. [Plaintiff]’s state tort claim, by contrast, would require [defendant] to add a cancer warning to its labels. That [state]-law requirement is “in addition to” and “different from” [defendant]’s federal-law labeling obligations.
2026 WL 1825691, at *8. Hence the title of this post, that “‘different from’ and ’ in addition to’ mean what they say.” Particularly in the recalcitrant Third Circuit, Durnell is further proof that, yes, the Supreme Court’s abolition of any presumption against express preemption applies to product liability litigation.
As for Bates, Durnell distinguished its adverse aspects as involving a claim rarely seen in product liability – challenging the product’s “efficacy” rather than its safety. Id. Far more pertinent, the Court held, was its later preemption decision in Riegel v. Medtronic, Inc., 552 U. S. 312 (2008) (see, e.g., our discussions of Riegel here, here, and here). Riegel, as all regular Blog readers well know, is the basis for broad preemption of tort claims against FDA pre-market approved (“PMA”) medical devices. Seven justices in Durnell held that “Riegel further confirms that [plaintiff]’s failure-to-warn claim is expressly preempted,” 2026 WL 1825691, at *8, because §360k(a)’s nearly identical language likewise preempted claims challenging the FDA’s “review [of] the device’s label and [its] determin[ation] that the label is neither false nor misleading.” Id. The Durnell court viewed an FDA medical device PMA as equivalent (“just as”) to the EPA’s approval (called “registration”) of regulated chemicals. Id. Thus,
Riegel is dispositive here. If FDA’s premarket approval of medical devices preempted additional state-law requirements, so too must EPA’s registration of pesticides and approval of pesticide labels.
Id. at*9. Both statutes “reflect Congress’s judgment that the ability to sell a product throughout the country with a single label can be important to maintaining an efficient nationwide market.” Id. That’s an important concept for us to remember – uniformity in labeling is an economic virtue that Congress has chosen to protect through preemption.
The Court’s view of Riegel as “dispositive” also has implications for non-warning claims in Roundup litigation. We expect the other side to disagree, but they are whistling past the preemption graveyard. Why? Riegel. Based on the same “different from”/”in addition to” preemption language, Riegel held that numerous non-warning claims were also preempted by the FDA’s device approval. 552 U.S. at 320-21 (preemption extends to “strict liability; breach of implied warranty; . . . negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the [product; and] . . . negligent manufacturing”). To the extent that Roundup plaintiffs try to fall back on non-warning-related claims, the “dispositive” Riegel decision should bar those claims as well.
As to Riegel, we also were also heartened by Durnell’s footnote 9, which reiterated something that the lower courts have been forgetting in medical device litigation – Riegel did not create an exception for so-called “parallel claims”:
Riegel did not consider state-law claims that were parallel to an applicable federal requirement, apart from the FDA’s premarket approval process. . . . It is true that Riegel did not assess whether the state-law claims at issue were “different from, or in addition to” the relevant federal-law requirements.
Id. at *12 n.9 (emphasis added). Too many courts seem to view Riegel as affirmatively authorizing “parallel” claims, when in fact the Court did no such thing, since it never considered that issue at all. Durnell did, and the existence of purportedly “parallel” claims did not defeat preemption, because “EPA’s analogous registration and label approval determinations” were nevertheless “‘requirements’ under FIFRA.” Id. We should be reminding courts, first, that Riegel did not endorse the waived concept of parallel claims, and second, that such claims are still “requirements” that can be “additional to” governmentally imposed requirements.
The good news for defendants does not stop with the Court’s applying Riegel and finding preemption. Durnell went on to demolish a number of anti-preemption arguments that plaintiffs in prescription medical product liability litigation have also frequently raised.
Number 1 – That tort law and FDA regulation are compatible because both promote safety. Not good enough. “[T]hat argument operates at far too high a level of generality and disregards the central and comprehensive role that [the agency] performs in making labeling determinations under [the statute’s] registration provisions.” Durnell, 2026 WL 1825691, at *9.
Number 2 – Reliance on general “misbranding” or “adulteration” provisions to attack product-specific labeling. The general does not control the specific. “Reliance on [the statute’s] general standard for misbranding rather than the specific requirements imposed under federal law would nullify [the] preemption clause and the uniformity that Congress sought for safety warnings on [product] labels.” Id.
[Plaintiff’s] failure-to-warn claim does not fault [defendant] for using a label different from the [agency]-approved labeling. [Plaintiff] instead faults [defendant] for not using a label different from the [agency]-approved label. But [the statutory] preemption clause expressly preempts any state tort claim that would require a [regulated] manufacturer to use a label “in addition to” or “different from” federal requirements imposed under [the statute], which, as explained above, include the [agency]-approved label.
Durnell, 2026 WL 1825691, at *10. This holding in Durnell should be particularly useful in OTC drug litigation, where some courts have erroneously credited such arguments.
Number 3 – Product-specific requirements not having preemptive force. That argument was worse than wrong; it was “implausible.” Id. “[B]y its text, [the statute] affords preemptive force to federal requirements imposed ‘under’ [it], not merely those imposed ‘by’ the actual statute.” Id. The same is true of §360k(a), thus this argument also “contravenes Riegel.” Id. at *10. The statute also authorizes the agency to “prescribe regulations” and “make registration and labeling decisions.” Id. at *9. “There is no good argument for treating FDA’s premarket approval as ‘requirements’ ‘under’ the Medical Device Amendments, but not treating EPA’s regulations and registration determinations as requirements under FIFRA’s materially identical preemption clause.” Id. *10.
Number 4 – Loper Bright. Given the statute’s express delegation of power to prescribe regulations and to “determine” labeling compliance, Loper Bright Enterprises v. Raimondo, 603 U. S. 369 (2024), is completely inapplicable to preemption.
[The statute] empowers [the agency] to “prescribe regulations. . . .” And [it] expressly directs [the agency] to register [products] and determine that the [their] labeling complies with [the statute’s] many specific requirements. During that extensive registration process, [the agency] critically evaluates the [product] label to ensure that the label contains all warnings necessary to protect human health. After [the agency] makes a determination about the appropriate warnings for a [product’s] label, a manufacturer is legally required to use that label unless and until [the agency] subsequently approves or requires a new label.
Durnell, 2026 WL 1825691, at *10 (citations and quotation marks omitted). Change “register” to “approve” and, again, you have the FDCA (for both drugs and devices). As we’ve argued before, Loper Bright only applies to agency statutory interpretation (like that wrongly credited in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)), and not to delegated agency power to regulate particular products. The Supreme Court so held in Durnell.
Number 5 – Hindsight-based “unilateral” label change arguments. That didn’t cut it either. It doesn’t appear that the EPA has any equivalent to the FDA’s “changes being effected” regulations, so this aspect of Durnell does not map exactly to the FDCA. But Durnell reiterated that federal law preempts any state-law demand for a label change when a manufacturer has no ability to change it unilaterally:
[I]f the manufacturer unilaterally changed the label, as [plaintiff] says [defendant] should have done, the manufacturer would be flouting [agency] regulations and exposing itself to potentially severe federal penalties. So [plaintiff’s] argument also triggers potential retroactivity and estoppel questions. The law is not ordinarily read to retroactively penalize persons for doing what the Government had required them to do.
Id. at *11 (citations omitted). More broadly, Durnell rejected arguments that “would negate [the] express preemption clause, expose manufacturers to potentially massive tort liability for doing what [the agency] required them to do, and eviscerate the ‘uniformity of [agency] labeling determinations.” Id. (citation omitted).
Number 6 – Failure to report new information. That the government “was statutorily authorized to withdraw premarket approval for a medical device based on newly reported data or existing information” did not prevent preemption. Id. at *12. That power was solely vested in the government, not private plaintiffs. That the government might determine that an “approved” label “had in essence become misbranded over time due to new evidence does not deprive [existing] registration decisions of their preemptive force.” Id. “[E]xtensive processes” for gathering and reporting of new risk information did not reduce the scope of preemption.
[Plaintiff’s] policy concern about regulatory lag is amply addressed by the extensive processes that [the statute and its] implementing regulations have established to respond to new or evolving safety information. For example, manufacturers must apprise [the agency] of new information ‘regarding unreasonable adverse effects’ of their [products]. That obligation is backed by civil and criminal penalties.
Durnell, 2026 WL 1825691, at *12. Conspicuously absent from the Court’s discussion of the “many ways of ensuring a [product’s] continued compliance” is any allowance of private litigation concerning purported failures to report. Id. Instead, “if third parties (like [plaintiff]) want to bring new information to [agency’s] attention or if they believe that [the agency] has failed to consider relevant information, those third parties are free to petition [the agency].” Id. at *13. The same is true of the FDA. Thus:
[The agency] possesses a variety of tools to learn of and address new safety information. And as a matter of law, state tort law may not impose labeling requirements “in addition to” or “different from” federal requirements imposed under [the statute].
Id.
That’s a lot of valuable new preemption ammunition that defendants in prescription medical product liability litigation can now rely upon.
Obviously, Durnell is a huge win for the defendants in the Roundup litigation. But almost as obviously, it is also a big win for our medical device, OTC drug, and other clients who manufacture and market products that Congress intended to be regulated by the FDA, not by the states, and that are accordingly protected by the various preemption clauses in different parts of the FDCA.