Facts of the Case
John L. Durnell used Monsanto’s product Roundup, a herbicide containing the active ingredient glyphosate. Durnell subsequently developed non-Hodgkin’s lymphoma, which he alleged was caused by his exposure to Roundup and glyphosate. In January 2019, Durnell sued Monsanto, asserting claims for strict liability defective design, strict liability failure to warn, and negligence. Durnell claimed that Monsanto should have included a cancer warning on Roundup’s label to alert users to the risk of developing non-Hodgkin's lymphoma from glyphosate exposure.
After a jury trial in September 2023 in the Circuit Court of the City of St. Louis, the jury found in favor of Durnell on his strict liability failure to warn claim and awarded him $1.25 million in compensatory damages, but ruled for Monsanto on the defective design and negligence claims. Monsanto moved for judgment notwithstanding the verdict, arguing that federal law—specifically the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)—both expressly and impliedly preempted Durnell’s failure to warn claim. The trial court denied the motion, and Monsanto appealed to the Missouri Court of Appeals, Eastern District, which affirmed the judgment.
Questions
Does the Federal Insecticide, Fungicide, and Rodenticide Act preempt a label-based failure-to-warn claim where EPA has not required the warning?
Conclusions
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When the EPA approves a pesticide label without a specific warning, that approval creates a federal labeling requirement under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and any state lawsuit demanding that missing warning is expressly preempted. Justice Brett Kavanaugh authored the 7-2 majority opinion.
FIFRA’s preemption clause, titled “Uniformity,” forbids states from imposing pesticide labeling requirements that are “in addition to or different from” those required under FIFRA. The statute tasks the EPA with reviewing every pesticide label before approving it for sale, and the EPA must confirm that the label contains all warnings “necessary and adequate to protect health and the environment” and contains no false or misleading statements. Once the EPA approves a label, manufacturers must use that exact label—they face civil and criminal penalties if they change it without EPA authorization. Because the EPA repeatedly reviewed and approved Roundup's label without a cancer warning, federal law required Monsanto to sell Roundup without one. A state lawsuit demanding that Monsanto add a cancer warning imposes a labeling requirement that goes beyond what federal law demands. Prior precedent establishes that state tort duties—including failure-to-warn claims—qualify as labeling requirements for preemption purposes. Durnell’s claim therefore falls squarely within what FIFRA’s preemption clause prohibits.
The Court’s 2008 decision in Riegel v. Medtronic reinforces this conclusion. In Riegel, the Court held that FDA approval of a medical device preempted state tort claims under a nearly identical preemption clause in the Medical Device Amendments. The FDA’s device approval process works the same way as the EPA’s pesticide registration process: both agencies review and approve labels for safety, and both require manufacturers to use approved labels without unauthorized changes. If FDA approval creates binding federal requirements that block additional state claims under the Medical Device Amendments, then EPA approval does the same under FIFRA. The Court also distinguished its earlier decision in Bates v. Dow Agrosciences: in Bates, the state claims targeted a pesticide's efficacy representations, which the EPA does not evaluate at registration. Here, the claim targets safety warnings, which the EPA thoroughly evaluates. Safety determinations are the core of EPA’s registration process, and its specific conclusion that Roundup does not require a cancer warning carries preemptive force.
Justice Clarence Thomas concurred, agreeing with the majority’s statutory analysis but writing separately to flag constitutional concerns—that FIFRA may exceed Congress’s Commerce Clause authority by regulating intrastate use of pesticides, that Congress may have improperly delegated core legislative power to the EPA, and that it remains an open question whether agency action can properly preempt state law under the Supremacy Clause.
Justice Ketanji Brown Jackson dissented, joined by Justice Neil Gorsuch, arguing that the EPA’s registration approval does not create a “requirement” under FIFRA because the statute itself says registration “shall not be construed as a defense” to a misbranding charge, meaning the approved label may still be unlawfully deficient; the only relevant federal requirement is FIFRA’s ongoing misbranding prohibition, which parallels Missouri’s failure-to-warn standard rather than conflicting with it, and therefore does not trigger preemption.
