As of May 2022, Monsanto, the company that developed the allegedly cancer-causing weed killer Roundup, has settled more than 100,000 lawsuits, and paid nearly $11 billion in settlements.1 Despite this massive number, 30,000 lawsuits remain pending.
In Carson v. Monsanto Company (“Carson”)2, a recent U.S. Eleventh Circuit ruling offers insights into the complex interplay between federal and state regulation. But what does this mean for FIFRA?
The Case
Like many other plaintiffs in these lawsuits, John Carson used Roundup on his lawn for over thirty years. When he was diagnosed with malignant fibrous histiocytoma, a form of cancer, he stopped. Carson then filed suit against Monsanto alleging that Roundup contained glyphosate, a dangerous carcinogen; in the complaint, he asserted that Monsanto not only was aware of Roundup’s harmful effects, but also that the company failed to warn customers of the dangers. He alleged four causes of action under Georgia state law: strict liability for a design defect (Count I); strict liability for failure to warn (Count II); negligence (Count III); and breach of implied warranties (Count IV).
Monsanto moved for judgment on the pleadings on the grounds of the Federal Insecticide, Fungicide, and Rodenticide (FIFRA) preemption provision.3 In an effort to deter states from enacting their own pesticide labeling and packaging standards, the provision grants the Environmental Protection Agency (EPA) strict authority to enforce uniformity across all fifty states. A state, therefore, cannot enact any labeling or packaging standards that are “in addition to,” or “different from,” federal standards. Under FIFRA, two types of preemption can be invoked: express preemption being written into the applicable statute and implied preemption being determined by the presence and extent of specific EPA regulation and policy objective in a particular area.4 For a state pesticide regulation to be preempted, two conditions must be satisfied: the regulation must be required for labeling and packaging; and the regulation must impose a requirement that is “in addition to or different from” those required by the federally registered label.5
Monsanto claimed that the Agency’s previous approval of Roundup’s labeling and continued adherence to the reasoning for that decision expressly preempted Carson’s suit. Monsanto argued that because the Agency declined to require a cancer warning when it registered and continued to approve Roundup for sale, requiring a label with such a warning would be “in addition to” or “different from” FIFRA’s requirements.
The District Court granted Monsanto’s motion in part. Specifically, the Court ruled that FIFRA expressly preempted Carson’s failure-to-warn and breach-of-implied-warranty claims, dismissing Counts II and IV of the complaint. The Court also dismissed Counts I (design defect) and III (negligence) as preempted to the extent that those claims related to Roundup’s labeling or packaging. Because it ruled on express-preemption grounds, the District Court did not address Monsanto’s alternative claim that Counts II and IV were impliedly preempted.
However, the Court did address and reject implied preemption with respect to Counts I and III. The District Court reasoned that, because FIFRA gives states the authority to regulate pesticides, it would not be impossible for Monsanto to comply with both state-law and FIFRA requirements for manufacturing and design.
The parties subsequently settled. In accordance with a “high-low” settlement agreement, Carson moved to amend his complaint to dismiss Counts I and III but preserved his right to appeal Count II, the failure-to-warn claim. The District Court granted that motion, and Carson timely appealed.
The Appeal
On appeal, a panel of the U.S. Eleventh Circuit determined that FIFRA did not preempt Carson’s failure-to-warn claim. The Court concluded that Georgia’s common-law standard for product-safety warnings imposes less of a duty than FIFRA’s prohibition against marketing misbranded pesticides, and that the Agency’s approval of Roundup’s labels without a cancer warning did not preempt the Georgia cause of action because only federal action with the force of law has the capacity to preempt state law. The Court analyzed whether the Agency’s registration process carried the force of law and determined that it did not.
The entire Eleventh Circuit, sitting en banc, then vacated the panel opinion and granted rehearing on the role of a “force-of-law” analysis in the context of express preemption. Sitting en banc, the Court held that a force-of-law inquiry is usually irrelevant where Congress has enacted an express preemption provision. Rather, an express-preemption analysis applies the text of the preemption provision in line with ordinary principles of statutory interpretation. The En Banc Court remanded to the original panel the question of whether Carson’s failure-to-warn claim was preempted, either expressly or impliedly. The En Banc Court also left for the panel’s consideration Carson’s argument that section 136v(b)’s reference to “requirements” compels a force-of-law inquiry as a matter of statutory interpretation.
On remand, the original panel again rejected preemption.
Reasoning
Initially, as a matter of express preemption, the Court noted that FIFRA does not preempt state-law duties, including common-law claims, that “parallel” or “are fully consistent with” federal requirements. So, while FIFRA may preempt additional state “requirements,” it does not preempt additional state “remedies” for violations of federal law. Rather, FIFRA authorizes a relatively decentralized scheme that preserves a broad role for state regulation. Under FIFRA, a pesticide is misbranded if, for example, its label does not contain a warning or caution statement which may be necessary and if complied with is adequate to protect health and the environment.6
FIFRA’s prohibition on misbranding effectively imposes a strict-liability standard, as it contains no element of knowledge or intent. By comparison, under Georgia common law, a pesticide manufacturer breaches its duty to warn if it fails to provide an adequate warning of the product’s potential risks. But this is not a limitless standard—the manufacturer is liable only if it knows or reasonably should know of the danger arising from the use of its product. And that duty extends to only nonobvious foreseeable dangers from normal use. If anything, Georgia common law about failure-to-warn claims imposes less of a duty on pesticide manufacturers than FIFRA.
The Court then rejected the argument that the registration process preempts failure-to-warn claims. Having said that, the Court went on to argue against equating individual EPA approvals for pesticides with the broader requirements set forth in FIFRA. The Agency has been empowered by Congress to assess whether pesticide label adheres the broad standards set forth by federal law. As detailed in the ruling, because the panel determined that the EPA’s individual approvals are not a rule of law that must be obeyed, these actions are not “requirements” under FIFRA.
The Court then also rejected Monsanto’s implied preemption argument. They note that Monsanto relies on two key EPA actions: “the Agency’s 1993 determination that glyphosate met FIFRA’s requirements for re-registration, and its 2019 letter saying that California’s cancer warning for glyphosate would be a ‘false and misleading statement’ in violation of FIFRA.” However, the Court claims that these actions “don’t meet the ‘demanding’ standard for impossibility preemption.” Meaning the Agency’s approvals of glyphosate without a cancer warning do not prove the impossibility of such a warning, “nor does the Agency’s concurrent classification of glyphosate as not likely to be carcinogenic to humans alter this conclusion.” The Court also found that Monsanto is unable to show that the EPA told Monsanto that it would not approve changing the label to include that warning because, “based on the record before us, Monsanto did not request—and the Agency did not consider, much less reject—a cancer warning at all.” Therefore, the impossibility preemption is not applicable.
The Court concluded the same for the EPA’s 2019 letter. Because this letter was issued after Carson was diagnosed with cancer and filed the lawsuit, “it does not necessarily reflect the Agency’s position during the time Carson used Roundup. But even if it did, the 2019 letter was directed at California’s specific Proposition 65 warning and did not conclude that any and all warnings related to glyphosate’s potential cancerous effects would render a pesticide ‘misbranded’.” Again, not enough for impossibility preemption, seeing that the letter only dealt with California’s warning.
In 2022, the EPA stated it could approve a warning about glyphosate’s cancer risks set forth by the International Agency for Research on Cancer, and “products with that warning would not be considered misbranded.” This position was expressed by the Agency years after Carson’s lawsuit but still undermines Monsanto’s claim of impossibility. Because according to the Court: “If, in the Agency’s own words, it could approve a warning similar to the one Carson seeks, and products with a warning like that would not be ‘misbranded’ under FIFRA, Monsanto could comply with both state and federal labeling requirements. And no irreconcilable conflict exists.”
Therefore, based on the Court’s findings that the EPA’s 1993 approval of glyphosate without a cancer warning did not exclude the potential for one such warning, that the 2019 letter was not directly applicable to Georgia’s state laws, and that the EPA’s 2022 position implies the possibility of warning approval had one been requested, Monsanto’s cannot claim that it is impossible to include cancer warnings, and “FIFRA does not impliedly preempt the warning that Georgia law would require.”
Future Failure to Warn Claims
In Carson v. Monsanto, the Court's analysis, particularly concerning the failure-to-warn claim, highlights the need to distinguish between federal mandates and administrative directives lacking the force of law. Despite Monsanto's reliance on specific EPA actions to oppose cancer warnings, the Eleventh Circuit Court suggests that these actions do not definitively block such warnings. This underscores a delicate balance between federal and state interests in glyphosate labeling, with flexibility for interpretation within existing regulatory frameworks. With 30,000 lawsuits against Monsanto pending, it will be interesting to see how they play out.
1 Roundup Lawsuit Update February 2024
2 Carson v. Monsanto Company, No.21-10994, 2024 WL 412081 (11th Cir. Feb. 5, 2024).
3 7 U.S.C. §136v(b)
4 https://nationalaglawcenter.org/wp-content/uploads/assets/articles/FIFRA-Fact-Sheet-w.pdf
5 Bates v. Dow AgroSciences LLC, 544 U.S. 431, 444 (2005).
6 7 U.S.C. §136(q)(1)(G).
