Pesticides can cause cancer. For that reason, they have long been the subject of state regulation. However, pesticide manufacturers like Monsanto Company have attempted to utilize the preemption doctrine to avoid liability for their carcinogenic products. After its arguments were unsuccessful in the Ninth and Eleventh Circuits, Monsanto’s claim that a federal pesticide regulation preempted state action found success in the Third Circuit in Schaffner v. Monsanto. The facts of all three cases were substantially the same: Plaintiffs with cancer brought state law failure-to-warn claims against Monsanto for failing to include a cancer warning on the label of its pesticide, Roundup. While the Ninth and Eleventh Circuits held that the state-law claims were not preempted, the Third Circuit disagreed. In opening this fissure between the circuits, the Third Circuit invited the Supreme Court to close it, noting that “the issue presented by this case, which is clearly of general interest, has yet to be decided by the highest court capable of resolving it — the United States Supreme Court.” If the Supreme Court grants certiorari, its holding could hamstring plaintiffs seeking redress for environmental and health-related harms.
Monsanto, now Bayer after its acquisition in 2018, manufactures Roundup with the active ingredient glyphosate. While the Environmental Protection Agency (EPA) has classified glyphosate as non-carcinogenic, the International Agency for Research on Cancer (IARC) found in 2015 that the chemical was “probably carcinogenic to humans” and that “non-Hodgkin’s lymphoma is among the types of cancer most closely associated with glyphosate.” After the IARC announcement, plaintiffs began to bring claims against Monsanto alleging that their cancers were caused by Roundup use, and many of those actions were consolidated for pretrial purposes into In re Roundup Products Liability Litigation. In 2021, ruling in favor of the plaintiffs in the multidistrict litigation’s first bellwether trial, Hardeman v. Monsanto Co., the Ninth Circuit rejected Monsanto’s argument that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) preempts state failure-to-warn claims. The Eleventh Circuit cast aside the same argument in a parallel case, Carson v. Monsanto Co., regarding a different cancer in 2022.
Adding to the over 150,000 Roundup lawsuits, Mr. David Schaffner, Jr. brought his own case. Mr. Schaffner received a diagnosis of non-Hodgkin’s lymphoma in 2006 after being exposed to Roundup for years in his work as a landscaper. In May 2019, Mr. Schaffner and his wife (who sought damages for loss of consortium) brought six claims in Pennsylvania state court, including one failure-to-warn claim on the theory that Monsanto failed to include a cancer warning in Roundup’s labeling. Monsanto removed to federal court in the Western District of Pennsylvania. The Schaffners and Monsanto agreed to drop all claims other than failure-to-warn with a joint stipulation that Monsanto retained the right to appeal the district court’s rejection of its preemption arguments. While “the parties remained adverse and in disagreement with respect to those orders,” they settled the remainder of the suit and agreed that damages be determined based on the outcome of the appeal. The district court ultimately entered judgment for the Schaffners, and Monsanto appealed.
In defending its claim against the Schaffners, Monsanto essentially restated its defenses from the Ninth and Eleventh Circuits. It argued that FIFRA expressly preempts any state law cause of action regarding pesticide labeling. FIFRA requires that all pesticide labels obtain EPA approval through a registration process, and those labels cannot be altered without renewed approval. The Third Circuit dubbed this provision the “Preapproval Regulation.” FIFRA’s “uniformity” provision establishes that no state may “impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under” FIFRA. Monsanto asserted that when determining if a state labeling requirement differs from FIFRA, the “Federal Comparator” should include the EPA’s Preapproval Regulation. The Federal Comparator is the federal provision to which the state provision must be compared when determining if the state law requirement is equivalent to the federal requirement. The breadth of the Federal Comparator essentially determines how much state action is preempted by FIFRA; including a federal provision in the Federal Comparator means that any state law that imposes requirements that differ from that provision are preempted. If the Preapproval Regulation is included in the Federal Comparator, any state law cause of action cannot require a warning that is not exactly equivalent to a pesticide’s EPA-approved label, as the manufacturer would have to submit a new application to the EPA to alter the label. Thus, because Roundup’s EPA-approved label does not include a cancer warning, Pennsylvania law cannot hold Monsanto liable for failing to include that language.
The Schaffners asserted that state laws need comply only with FIFRA’s misbranding provision, which generally prohibits companies from misleading consumers with their labelling practices. FIFRA’s misbranding provision “prohibits the distribution or sale of a pesticide that is ‘misbranded,’” defined as a label that “does not contain a warning or caution statement which may be necessary and if complied with . . . is adequate to protect health and the environment.” The Schaffners argued that the Pennsylvania failure-to-warn cause of action prescribed the same labelling practices that would be required under the misbranding provision of the federal law. Therefore, the state law would not be preempted. Specifically, Pennsylvania common law creates liability for products “distributed without sufficient warnings to notify the ultimate user of the dangers inherent in the product.” Thus, a label that violates Pennsylvania law would also violate federal law because the label “arguably lack[s] a warning ‘necessary . . . to protect health’ and thereby satisfie[s] the statutory definition of misbranding” under FIFRA.
Further, FIFRA provides that “[i]n no event shall registration of an article be construed as a defense for the commission of any offense” under the statute, including misbranding. The Schaffners argued that “a pesticide may be misbranded even if it is registered” and that Monsanto wrongly attempted to use “registration as a defense to misbranding.” In other words, the statute expressly limits the fact of a pesticide’s approval to merely serving as “prima facie evidence” that the pesticide is not misbranded. In the Schaffners’ view, by arguing that the approval of the pesticide’s label precludes any state law labelling requirements, Monsanto was attempting to use the mere fact of EPA approval of Roundup’s label as a complete defense against misbranding. Because FIFRA explicitly prohibits that logic, “the Schaffners conclude[d] that the Federal Comparator must incorporate only the broad statutory definition of misbranding,” not the EPA’s registration decisions under the Preapproval Regulation.
In addition, the Schaffners argued that only EPA decisions that carry the force of law can preempt state law. As EPA approval decisions do not carry “the force of law, they cannot affect the content of the Federal Comparator.” For that reason, the Preapproval Regulation cannot be included in the Federal Comparator, so the content of Roundup’s preapproved label need not be compared to Pennsylvania state law requirements. Therefore, incorporating the misbranding provision and excluding the Preapproval Regulation, FIFRA’s requirements are equivalent to those of Pennsylvania law.
Monsanto achieved a win in the Third Circuit. The court of appeals ruled in favor of Monsanto, holding that FIFRA preempts Pennsylvania’s failure-to-warn cause of action. Reviewing the preemption question de novo, the court applied the “parallel requirements” test from Bates v. Dow Agrosciences LLC. Under this test, a state provision is preempted if it imposes a requirement “in addition to or different from” those mandated under FIFRA. Simply put, if a label violates the state provision but not the federal one, the state provision is preempted. The Third Circuit reasoned that the Preapproval Regulation is itself a requirement and “give[s] content to FIFRA’s misbranding standards.” Because “federal requirements must be articulated at the more specific level,” the Preapproval Regulation must be included in the Federal Comparator. By the same logic, the court explained that the misbranding provision should not be included in the Federal Comparator, because the statute defines misbranding as “the omission of warnings ‘necessary . . . to protect health’” and the EPA approval process determines which warnings are needed “to protect health,” so an approved label is necessarily not misbranded according to the EPA. In a footnote, the court noted that it did not consider whether Pennsylvania law could require Monsanto to apply to the EPA for renewed approval because the Schaffners did not advance that argument.
Finally, the court reasoned that federal requirements have the force of law, so no Mead analysis was necessary. The Third Circuit explained that the Carson and Hardeman courts relied primarily on the Supreme Court’s decision in Wyeth v. Levine, which held that an agency action without the force of law did not have preemptive effect. The court argued that Wyeth dealt solely with implied preemption, in contrast to the Preapproval Regulation, which contains an express preemption clause. Due to the inclusion of that express preemption clause, the Preapproval Regulation constitutes a requirement, giving it the force of law and thus preemptive effect. Therefore, the court held that because the cancer warning was required under Pennsylvania law but could not be added to Roundup’s label without violating the EPA’s Preapproval Regulation, Pennsylvania law imposed a requirement “in addition to or different from” FIFRA and thus was preempted.
The roots of the disagreement between the Third Circuit and the Ninth and Eleventh Circuits were the Federal Comparator and force of law analyses. The Ninth and Eleventh Circuits held that the label violated both state law and FIFRA’s misbranding provision despite the EPA’s approval of the label, and in any case, the EPA’s registration process lacked the force of law and could not preempt a state law claim. Further, the Ninth Circuit speculated that because Monsanto could have applied to the EPA for approval of a new label, the Preapproval Regulation might preempt state law if the “EPA took certain enforcement action against Monsanto after a cancer warning was added to Roundup’s label.” However, as the Third Circuit opinion noted in a footnote, the court did not address this argument because the Schaffners did not raise it. Therefore, the circuit split hinges on two questions: Does the EPA’s approval process carry the force of law and thus preemptive effect? If so, does EPA approval of a label preempt state failure-to-warn claims?
While the Third Circuit limited its holding, ruling “only that such duties may sometimes be preempted, including in the circumstances of this case,” new Supreme Court precedent would inevitably reach beyond the case at issue. If the Supreme Court answers the Third Circuit’s call to action, it should decline to turn the Third Circuit’s flawed preemption analysis into binding national precedent. The Third Circuit’s reasoning is erroneous, as Congress did not intend for EPA approval to end the conversation about pesticide safety by preempting state failure-to-warn claims and preventing enforcement of its misbranding provision.
Congress crafted registration as an ongoing process, allowing the EPA to continue monitoring pesticide safety and revoke or amend an approved label if new health risks come to light. The ability to update EPA approved labels undercuts the Third Circuit’s inclusion of the Preapproval Regulation in the Federal Comparator, as that capability supports the notion that Congress did not intend for approval to set labels in stone. FIFRA’s explicit mandate that “[i]n no event shall registration of an article be construed as a defense for the commission of any offense” within the statute implies that an outside entity may bring an action against a manufacturer, as the statute already provides that the EPA can require that approved labels be altered to prevent misbranding. State common law is the most logical avenue for these claims, so the care that Congress took to allow for third-party suits makes clear that Congress intended to allow concurrent state enforcement of statutory offenses.
By the same reasoning, this case does not have significant implications for agency authority, as Congress did not intend for FIFRA to occupy the field of pesticide labeling. Preemption prevents state action from undercutting federal authority, and there is no such conflict here given that the state failure-to-warn cause of action essentially enforces FIFRA’s misbranding provision.
However, a Supreme Court affirmation of the Third Circuit’s holding would be disastrous for toxic tort plaintiffs. The EPA’s regulatory regime is imperfect. For instance, the EPA does not require a cancer warning for a pesticide containing an ingredient that is likely carcinogenic and is the subject of nearly 100,000 settlements totaling $11 billion in damages and 54,000 active lawsuits brought by cancer victims. State failure-to-warn laws serve to enforce FIFRA’s misbranding provision and compel corporations to update their labelling practices when the EPA fails to act. If EPA approval preempts virtually all state law causes of action against pesticide manufacturers, then victims will have few means of seeking compensation and vindicating their rights to be informed of potential health hazards. However, this is not the outcome that Congress intended when it passed FIFRA, considering that it specifically provided that registration should not be used as a defense against any violation of the Act. The Third Circuit read field preemption into the statute where there was none, shutting the door on future Roundup plaintiffs absent Supreme Court intervention.
Even worse, if EPA approval is a complete defense against failure-to-warn claims, manufacturers will have little incentive to ensure the safety of their products or provide further information about potential health harms once their labels are registered. Because the EPA usually reviews pesticide registrations only once every 15 years, if scientists discover that a product is more dangerous than previously thought, that product could remain on the market for over a decade without an updated label. Without state tort remedies, consumer products will become more hazardous, and they will lack adequate labels to warn us of those hazards. If it chooses to resolve the circuit split, the Supreme Court should carefully consider the impact of its decision on preemption doctrine and the safety of our products, taking care not to leave toxic tort victims with no remedy at all.
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