The Third Circuit Court of Appeals has split from the Ninth and Eleventh Circuits by concluding that the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) preempts the state law failure to warn claims commonly raised by plaintiffs in pesticide injury lawsuits. In a ruling issued on August 15, 2024, the Third Circuit concluded that the plaintiffs’ claim that Monsanto Corporation had violated a state law duty to warn consumers that using its glyphosate-based pesticide products could cause cancer were preempted by federal law and should not be heard in court. This marks the first time that a Circuit Court of Appeals has found that FIFRA preempts state law failure to warn claims, and by splitting from the Ninth and Eleventh Circuits, this case increases the possibility that the preemption issue could ultimately be heard by the United States Supreme Court. Should the Supreme Court take up the issue, the ruling would impact thousands of on-going pesticide injury lawsuits.

Background

For nearly a decade, there has been a growing trend of plaintiffs filing lawsuits claiming that a pesticide manufacturer has failed to warn them of the health risks involved in using their pesticide products. Of these cases, the most well-known have involved glyphosate, the active ingredient used in the pesticide Roundup. Since the first of these cases was filed in 2016, thousands of plaintiffs have filed lawsuits claiming that they were injured at least in part because a pesticide manufacturer failed to warn consumers of the risks of using a particular pesticide product. In that time, a key question has risen to the forefront of pesticide injury litigation – does FIFRA, a federal law, preempt the state law failure to warn claims that almost every pesticide injury plaintiff raises? To date, two federal Circuit Courts of Appeal have said no, while the Third Circuit Court of Appeals has said yes. Resolving this issue could be crucial for the future of pesticide injury lawsuits.

FIFRA is the primary federal law regulating pesticide use in the United States. A pesticide may not be legally sold or used without first having a label approved by the Environmental Protection Agency (“EPA”) pursuant to the requirements of FIFRA. To approve a pesticide label, FIFRA requires EPA to determine that, when used according to its label, the pesticide will not cause “unreasonable adverse effects on the environment.” 7 U.S.C. § 136a (c)(5)(C). FIFRA goes on to define “unreasonable adverse effects on the environment” as “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.” 7 U.S.C. § 136(bb). Once a label is approved, FIFRA strictly regulates how and when changes to labeling language can be made. FIFRA’s implementing regulations provide that once EPA has approved a label, “any modification in the composition, labeling, or packaging” of the pesticide product “must be submitted with an application for amended registration.” 40 C.F.R. § 152.44. In other words, after EPA has approved a pesticide label, the label language can only be modified if the registrant applies for amended registration and EPA approves the application. Additionally, states are prohibited from “impos[ing] or continu[ing] in effect any requirements for labeling or packaging in addition to or different from” those required under FIFRA. Finally, FIFRA also prohibits the sale of any pesticide which is “misbranded.” 7 U.S.C. § 136j(a)(1)(E). For the purposes of FIFRA, a pesticide is considered misbranded if “the label does not contain a warning or caution statement which may be necessary […] to protect health and the environment[.]” 7 U.S.C. § 136 (q)(1)(G). While FIFRA focuses on labeling consistency, the statute also emphasizes that a pesticide may not be sold if its label lacks necessary health and safety warnings.

Failure to warn is a type of civil tort commonly raised in products liability cases. Like most torts, failure to warn is based in state law and enforced at the state level. Typically, plaintiffs will raise failure to warn claims to allege that a manufacturer has failed to provide adequate warnings or instructions about the safe use of a product. While requirements can vary from state to state, in general to succeed on a failure to warn claim a plaintiff must prove two things. First, the plaintiff must demonstrate that the manufacturer did not adequately warn consumers of a particular risk associated with using a certain product. Second, the plaintiff must show that the risk was either known or knowable in light of the generally recognized best scientific and medical knowledge available at the time the product was sold. In essence, the manufacturer must have either known or been able to easily discover the risk, failed to warn consumers about that risk, and that failure caused injury to the plaintiff.

Plaintiffs in pesticide injury cases almost always raise a failure to warn claim as part of their lawsuit. They argue that the pesticide manufacturer knew or should have known that use of a pesticide product would result in a health risk to the user that the manufacturer failed to warn about, and that failure is the direct cause of the plaintiffs’ injuries. In response to these allegations, pesticide manufacturers argue that state law failure to warn claims should be preempted by FIFRA. Specifically, they argue that because FIFRA prevents states from adding any language to a pesticide label that is “different from or in addition to” the label approved by EPA, that plaintiffs cannot bring state law failure to warn claims because the only way to resolve those claims would be to include additional warning language to pesticide labels that EPA has not approved. However, pesticide injury plaintiffs argue that the failure to warn claims are not preempted by FIFRA because the claims are “parallel” to the FIFRA prohibition on misbranding. In other words, the plaintiffs claim that if a pesticide manufacturer has violated its state law failure to warn requirements, then it has also violated the FIFRA misbranding prohibition. For a more in-depth look at the question of preemption, click here.

As of August 2024, three Circuit Courts of Appeal have considered the question of whether FIFRA preempts state law failure to warn claims raised by pesticide injury plaintiffs. While the Ninth and Eleventh Circuits were both persuaded by the argument that failure to warn claims run parallel to the FIFRA prohibition on misbranding, the Third Circuit was not convinced. It has become the first Circuit Court of Appeal to conclude that FIFRA preempts failure to warn claims.

Third Circuit Decision

The plaintiffs in Schaffner v. Monsanto Corp., No. 22-3075 (3rd Cir. 2024) filed their lawsuit in 2019 in a state court in Pennsylvania. While they initially raised six different state law claims, by the time the case reached the Third Circuit Court of Appeals, the only claim remaining was failure to warn. Specifically, the question before the Third Circuit was: is a state law duty for a pesticide manufacturer to include a particular health warning preempted by a federal statute that expressly prohibits any state law pesticide labeling requirement that differs from or adds to the requirements imposed by federal law. After reviewing the arguments, the Third Circuit concluded that FIFRA preempted the plaintiffs’ failure to warn claims.

After reviewing the relevant provisions of FIFRA and Pennsylvania’s requirements for failure to warn, the Third Circuit began its analysis by examining the Supreme Court ruling Bates v. Dow Agrosciences LLC, 544 U.S. 431. In that case, the Court held that in order for a pesticide labeling requirement imposed by state law to be preempted by FIFRA, the requirement must meet two conditions. First, the requirement must be for labeling or packaging, and second, it must impose a labeling or packaging requirement that is “in addition to or different from” those required under FIFRA. According to the Third Circuit, Bates outlined a “parallel requirements” test wherein a state law pesticide labeling requirement would not be preempted if it is “equivalent to a requirement under FIFRA,” but would be preempted if it “diverges from those set out in FIFRA and its implementing regulations.”

After establishing that the question of whether the plaintiffs’ failure to warn claim was preempted by FIFRA could only be resolved through application of the parallel requirements test, the Third Circuit focused on which provisions of FIFRA should be used as the “Federal Comparator.” The Federal Comparator, as described by the Third Circuit, serves as the provision of federal law that a state law requirement will be compared to in determining whether the state law requirement is equivalent or parallel to federal law. The plaintiffs argued that the Federal Comparator should be limited to FIFRA’s prohibition on misbranding. The defendants disagreed, arguing that the Federal Comparator should include not only the misbranding prohibition, but also FIFRA’s limitation on state power and its regulations which provide that alterations to an approved label must be made via an application for amended registration.

Ultimately, the Third Circuit agreed with the defendant and concluded that the Federal Comparator should include FIFRA’s provisions on misbranding, and state authority as well as the regulations outlining how an approved label may be modified. According to the court, it was not enough to look at the misbranding prohibition on its own. Instead, it was necessary to be read together with other FIFRA provisions and regulations that give the misbranding prohibition “content.”

By using the Federal Comparator that included the misbranding and state authority provisions of FIFRA together with the regulations on label modifications, the Third Circuit concluded that the plaintiffs’ failure to warn claims failed the parallel requirements test and were preempted. The court reasoned that for the defendant to satisfy the plaintiffs’ failure to warn claims, it would have to add additional labeling language – specifically a cancer warning – to all glyphosate products sold in the state of Pennsylvania which the court concluded FIFRA would not allow the defendant to do. The court noted that FIFRA’s implementing regulations allow a pesticide manufacturer to modify a previously approved label only through submission of an amended registration application which EPA must then approve. A pesticide manufacturer may not change a registered pesticide label on its own without EPA approval. The court also highlighted that, to date, EPA has never concluded that glyphosate is a likely carcinogen. Therefore, it is unlikely that EPA would require a cancer warning for glyphosate-based products.

Because FIFRA prohibits states from adding any language to a pesticide label that is “in addition to or different from” the federally registered label, and because FIFRA regulations prohibit a pesticide manufacturer from adding language to an approved label without first applying to EPA, the Third Circuit concluded that the plaintiffs’ state law failure to warn claims were preempted by FIFRA.

Going Forward

The Third Circuit’s ruling in Schaffner v. Monsanto Corp. is likely to impact not only on-going lawsuits involving glyphosate, but all pesticide injury lawsuits throughout the United States. While the conclusion that failure to warn claims are preempted by FIFRA will only apply to those cases filed in the Third Circuit, by creating a split from the Ninth and Eleventh Circuits, this ruling makes it more likely that the Supreme Court could hear the issue. While the Supreme Court has previously rejected requests for it to take up the question of preemption, it has indicated that a circuit split would make it more appropriate for the high court to weigh in. In the meantime, it is possible that other Circuit Courts of Appeal may hear the issue and rule similarly to the Third Circuit.

To read the court’s decision in Schaffner v. Monsanto Corp., click here.

To read about the preemption rulings from the Ninth and Eleventh Circuits click here and here.

To read the text of FIFRA, click here.

For more National Agricultural Law Center resources on pesticides, click here.