The U.S. Supreme Court recently weighed in on the high-stakes battle over cancer warnings on pesticides, barring state lawsuits from holding companies liable for failing to warn consumers of potential cancer risks through labeling.
While this is a major victory for Monsanto, it should also be viewed as a win for medical device and over-the-counter drug manufacturers that market products regulated by federal agencies, as the Supreme Court ruling holds that preemption clauses found in statutes governing federal agencies bar states from adding additional regulation requirements.
The 7-2 ruling in Monsanto Co. v. Durnell comes after decades of glyphosate litigation. Glyphosate is the active herbicide in Monsanto’s Roundup weedkiller. Despite the World Health Organization’s International Agency for Research on Cancer classifying glyphosate as “probably carcinogenic” – a move that led to thousands of lawsuits producing billions in damages against Monsanto and Roundup – the U.S. Environmental Protection Agency (EPA) has conducted its own research and repeatedly ruled Roundup and similar herbicides do not need to carry a cancer warning. Despite the EPA determination, some courts have attempted to force the cancer-warning labels on to the herbicides.
The Durnell ruling says such lawsuits are barred because the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes the EPA to regulate the use, sale and labeling of pesticides and it includes a requirement prohibiting states from imposing additional labeling requirements.
In Durnell, Missouri gardener John Durnell sued Monsanto in 2019, alleging exposure to Roundup led him to develop non-Hodgkin’s lymphoma, a type of blood cancer, after using the product in his profession for more than 20 years. Durnell won more than $1 million on the failure-to-warn claim, a decision upheld at the appellate level.
The Supreme Court, however, ruled FIFRA preempts any state law requiring a warning label, because it would require a label “in addition to” or “different from” that required by the EPA, because federal law required Monsanto to use the EPA-approved label unless, and until, EPA approved or required a change. In essence, the Court concluded tort law and agency regulation are not compatible just because both promote safety.
Writing the majority opinion, Justice Brett Kavanaugh said the EPA undertakes an extensive review of products before authorizing labeling requirements that are applicable to all manufacturers. Because the agency had determined Roundup and others with glyphosate do not need to provide a cancer warning, “as a matter of federal law, Monsanto legally must use a label without a cancer warning unless and until EPA approves or requires a change.”
The federal government supported Monsanto in the case. In fact, President Trump signed an executive order in February to boost the production of glyphosate-based herbicides, saying the lack of access to the product threatened agriculture and the nation’s food system.
Wide-Ranging Impact of Durnell
The Durnell decision blocks thousands of lawsuits using the argument that lack of warnings on Roundup labels makes a company liable. But the decision has much broader impact. It provides valuable new preemption ammunition for defending litigation over medical devices and over-the-counter (OTC) drug products.
In Durnell, the Supreme Court cited Riegel v. Medtronic, Inc., noting that decision concluded the Food and Drug Administration’s (FDA) premarket approval process imposed product-specific federal requirements that preempted tort claims, based on the Medical Device Amendments’ preemption clause. That clause, the Supreme Court wrote in Durnell, is “materially identical” to that of FIFRA and several other preemptive clauses in federal statutes across a range of industries – proof Congress felt uniform labels were important enough to protect through preemption.
“Those similar labeling preemption clauses 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,” the Court opined in Durnell.
Further, the Court wrote, “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.”
Other Defense Support
OTC drug litigation often involves plaintiffs challenging product labels as false or misleading,
claiming the product doesn’t do what the label claims. In those cases, plaintiffs argue the manufacturer should apply a label different than the one approved by the U.S. Food and Drug Administration. Although Durnell arose in the pesticide context, the Court’s reasoning strongly supports preemption arguments in OTC drug cases involving FDA-authorized labeling. The decision suggests that where a state-law claim would require labeling different from federally authorized labeling, defendants may have significantly stronger preemption arguments.
The decision also provides important guidance regarding the interaction between agency action and preemption after Loper Bright Enterprises v. Raimondo. While Loper Bright eliminated Chevron deference for questions of statutory interpretation, the Court in Durnell still recognized EPA-approved labeling requirements as having preemptive force. In Durnell, the Court confirms Loper Bright applies to statutory interpretation, not the agency’s authorization to regulate products.
Importantly, the Court also rejected the argument that subsequently developed scientific information automatically defeats preemption. The Court explained that individuals who believe new evidence warrants different labeling may petition EPA to modify, suspend or cancel a registration, reinforcing that label changes remain within the agency’s regulatory authority rather than state tort juries.
So, a private party determining new information about a product, such as the possibility it causes cancer, does not provide that party the opportunity to, through subsequent lawsuits, force a label change. That power rests with the EPA, the Court concluded.
“The theoretical possibility that EPA could (despite its representation otherwise) try to bring a misbranding enforcement action against a pesticide manufacturer on the theory that the EPA-approved and EPA-required label had in essence become misbranded over time due to new evidence does not deprive EPA’s registration decisions of their preemptive force,” the Court wrote.
The Court added, “Moreover, if third parties (like Durnell) want to bring new information to EPA’s attention or if they believe that EPA has failed to consider relevant information, those third parties are free to petition EPA to modify, suspend, or cancel a pesticide’s registration.”
Durnell contains numerous defense-friendly preemption holdings that likely will be cited frequently in future medical device, OTC drug, food, cosmetic and other federally regulated product litigation.” Attorneys facing such actions should consult this decision for strategic purposes.
Harris Beach Murtha’s Medical and Life Sciences Industry Team frequently handles such cases and our attorneys are analyzing the decision for future use. If you need assistance with a case or have questions, please reach out to attorney Kelly Jones Howell at (212) 912-3652 and khowell@harrisbeachmurtha.com, or the Harris Beach Murtha attorney with whom you most frequently work.
This alert is not a substitute for advice of counsel on specific legal issues.
Harris Beach Murtha’s lawyers and consultants practice from offices throughout Connecticut in Bantam, Hartford, New Haven and Stamford; New York State in Albany, Binghamton, Buffalo, Ithaca, New York City, Niagara Falls, Rochester, Saratoga Springs, Syracuse, Long Island and White Plains; as well as in Boston, Massachusetts, and Newark, New Jersey.