Over the past decade, thousands of cases have reached federal courts to gain redress for injuries that plaintiffs have sustained while using Roundup, a popular pesticide manufactured by American agrochemical corporation Monsanto to kill weeds and insects in farming and landscaping. The flood of lawsuits comes in the wake of a 2015 report released by the International Agency for Research on Cancer (IARC), an agency of the World Health Organization. The report established glyphosate as a probable human carcinogen.¹ The plaintiffs suing Monsanto are typically cancer patients with non-Hodgkin’s lymphoma who attribute their cancer to glyphosate and file their lawsuits under state common law. Many state courts have articulated standards of product liability, one of which is failure-to-warn. Failure-to-warn claims assert that manufacturers failed to disclose to consumers a risk of product usage that they should reasonably have known.² 

Thus far, Monsanto has paid around $11 billion in settlements to plaintiffs filing failure-to-warn claims. Yet, there are still roughly 54,000 active Roundup lawsuits.³ In arguing that it is not liable for plaintiff injuries, Monsanto has asserted that state failure-to-warn claims are preempted by federal law. The law it refers to is the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). FIFRA regulates pesticides such as Roundup and establishes a registration process administered by the Environmental Protection Agency (EPA). Monsanto claims that because the EPA has consistently approved Roundup labels excluding a cancer warning during registration and re-registration processes, state requirements that Monsanto warn consumers of the threat of cancer constitute additional pesticide labeling requirements. Section 136v(b) of FIFRA stipulates that a “State shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter.”⁴ Thus, Monsanto argues that the difference in regulation means that federal requirements preempt state requirements. In recent years, federal circuit courts have considered Monsanto’s preemption argument. In 2021 and 2023, respectively, the Ninth and Eleventh Circuits ruled that EPA’s approval of a label lacking a cancer warning does not preempt state failure-to-warn claims because the state laws in question enforce FIFRA’s misbranding provision, which bans the sale of pesticides that are misleading in terms of their contents, uses, and dangers. However, in August 2024, the Third Circuit held that federal law does indeed preempt state failure-to-warn claims because EPA’s registration process gives substance to FIFRA’s misbranding provision and, therefore, carries the force of law. Thus, a circuit split has emerged on the topic of federal preemption of state consumer protection and merits attention because the Third Circuit’s ruling denies consumers redress for Roundup’s negative health impact. 

In this article, I argue that federal law does not preempt state law in failure-to-warn lawsuits against Monsanto. I contend that the Third Circuit incorrectly establishes EPA’s registration process as carrying the force of law. Rather, the proper focus of a preemption analysis is FIFRA’s provision prohibiting the misbranding of pesticides. State failure-to-warn laws do not impose different or additional labeling restrictions on manufacturers and instead help enforce FIFRA’s misbranding provision. 

Legal and Regulatory Background

Congress passed FIFRA in 1947 to provide federal oversight of pesticides as well as to protect human and environmental health. Initially, pesticide manufacturers registered with the U.S. Department of Agriculture, but amendments to FIFRA passed in 1972 shifted registration responsibility to the EPA. FIFRA mandates that manufacturers apply to the EPA for product registration before putting their pesticides on the market.⁵ FIFRA also outlines the procedure for registration. Under the procedure, manufacturers provide the EPA with a statement that includes the pesticide’s name, proposed label, complete formula, and a request for general or restricted use classification. FIFRA also requires that manufacturers provide the EPA with relevant data and gives the EPA the authority to specify what tests must be submitted to support the application. In the final step of product registration, manufacturers submit safety data and an initial label containing the necessary warnings. Once the EPA has reviewed the data submitted and approved the label, the pesticide is registered and can be sold.⁶

FIFRA contains three clauses relevant to the circuit courts’ preemption analyses. The first, mentioned earlier, is section 136v(b), which prohibits states from imposing pesticide labeling requirements diverging from FIFRA’s labeling requirements. The second is section 136j(a)(1)(E), which forbids the sale of a misbranded pesticide.⁷ According FIFRA’s definitions, misbranded products do not contain a warning on the label that “is adequate to protect health and the environment.”⁸ The third relevant clause is 136a(f)(2), which states that “[i]n no event shall registration of an article be construed as a defense for the commission of any offense under this subchapter. As long as no cancellation proceedings are in effect registration of a pesticide shall be prima facie evidence that the pesticide, its labeling and packaging comply with the registration provisions of the subchapter.”⁹

Two prominent cases that serve as precedent for FIFRA preemption cases are Bates v. Dow Agrosciences LLC and Riegel v. Medtronic, Inc. Bates entails analysis of FIFRA preempts state claims, while Riegel concerns the FDA’s regulation of medical devices. In Bates, argued before the Supreme Court in 2005, the petitioners were Texas peanut farmers alleging that Dow’s pesticide had stunted the growth of their crops. They filed a state common law failure-to-warn claim, asserting that Dow did not sufficiently label its product to warn of potential adverse effects. The Supreme Court established that state labeling requirements are not automatically preempted by 136v(b) because states can provide a remedy that federal law lacks. The court determined that FIFRA does not preempt state law so long as the state law satisfies a parallel requirements test. That is, state law can enforce FIFRA’s misbranding provision, but it cannot impose additional or different requirements. ¹⁰

A few years later, in 2008, the Supreme Court heard Riegel. In the case, Riegel sued Medtronic, a medical device company, when a Medtronic catheter ruptured in his heart following surgery. He claimed “that Medtronic’s catheter was designed, labeled, and manufactured in a manner that violated New York common law.” In particular, he filed claims of strict liability, breach of implied warranty, and negligence.¹¹ The FDA regulated Medtronic’s catheter under the Medical Device Amendments (MDA) of 1976. For Class III devices such as the catheter, the FDA requires a preapproval process akin to that of pesticides. Also similar to FIFRA, the MDA contains a clause prohibiting state requirements that are different from, or in addition to, federal requirements. The Supreme Court ultimately ruled that the FDA’s preapproval process constitutes a federal requirement, and New York’s common law requirements are preempted given that they add additional requirements beyond the preapproval process. 

Since Bates and Riegel, three major FIFRA preemption cases involving Monsanto have reached federal circuit courts. The first case is Hardeman v. Monsanto Company, heard before the Ninth Circuit in 2021. Following the typical formula of lawsuits against Monsanto, the case involved a plaintiff in California who contracted non-Hodgkin’s lymphoma after decades of frequently using Roundup. Monsanto argued that the EPA approved Roundup’s label without a cancer warning during the registration process, and, therefore, state failure-to-warn common law imposed an additional labeling requirement. The Ninth Circuit rejected Monsanto’s argument that FIFRA preempts Hardeman’s state law claim. The court applied Bates’ parallel requirements test, focusing on FIFRA’s misbranding provision rather than the EPA’s preapproved label due to the content of section 136a(f)(2), which asserts registration is not a defense against misbranding. The court concluded that California common law does not impose different or additional labeling requirements on manufacturers, as it “requires a manufacturer to warn … of any health risk that is ‘known or knowable’ (in strict liability) or those risks ‘a reasonably prudent manufacturer would have known and warned about’ (in negligence).”¹² Such a requirement aligns with FIFRA’s misbranding provision and thus is not preempted. 

In 2023, the Eleventh Circuit heard Carson v. Monsanto Company. Like Hardeman, Carson hinged on whether federal law preempts state law, except the state in question was Georgia rather than California. Georgia common law mandates that manufacturers inform consumers if their product is dangerous. The Eleventh Circuit, in concurrence with the Ninth Circuit, ruled that Georgia common law is parallel to FIFRA’s prohibition on misbranding. Further, the Eleventh Circuit looked to United States v. Mead Corp – a 2001 Supreme Court case determining when agency actions carry the force of law – to argue that the EPA’s registration process does not carry the force of law and, therefore, cannot preempt state law. The Supreme Court asserts in Mead that Congress grants agency action the force of law “when it provides for a relatively formal administrative procedure tending to foster the fairness and deliberation that should underlie a pronouncement of such force.”¹³ The Eleventh Circuit framed FIFRA’s section 136a(f)(2) as undermining the formality of the EPA’s registration process, preventing it from carrying the force of law.¹⁴ 

The final major FIFRA preemption case, which I shall consider in more detail below, is Schaffner v. Monsanto Corporation, on which the Third Circuit ruled in August 2024. Schaffner diverges from Hardeman and Carson by finding that the fact that the EPA approved a label omitting a cancer warning preempts Pennsylvania’s duty to warn law. The Third Circuit ruled that EPA’s registration process carries the force of law because it gives content to FIFRA’s misbranding provision. When applying the parallel requirements test, the court determined that Pennsylvania state requirements impose different obligations than the EPA’s registration process by requiring a cancer warning. In doing so, the Third Circuit diverged from its peer courts and ultimately ruled that Pennsylvania state law is preempted.¹⁵ 

The Proper Focus of the Parallel Requirements Test

Now that a circuit split exists on the question of federal preemption of state failure-to-warn claims, it is possible that the Supreme Court will weigh in on the matter. This section shall evaluate the logic of the Third Circuit in Schaffner as well as examine outside legal arguments as to why the EPA’s approval process should preempt state claims. 

The Third Circuit makes the flawed contention that the proper Federal Comparator – the federal requirement to which state laws are compared in preemption cases – is the EPA’s approval process rather than FIFRA’s misbranding provision. Two claims undergird this argument. First, Bates establishes that FIFRA “preempts any statutory or common-law rule that would impose a labeling requirement that diverges from those set out in FIFRA and its implementing regulations.”¹⁶ Second, the EPA’s registration process gives content to FIFRA’s misbranding provision. With regard to the former, the Third Circuit is correct that certain regulations specifically implement FIFRA’s provisions and carry the force of law. One example that it gives comes from Bates – “a failure-to-warn claim alleging that a given pesticide’s label should have stated ‘DANGER’ instead of the more subdued ‘CAUTION’ would be pre-empted because it is inconsistent with 40 CFR 156.64, which specifically assigns these warnings to particular classes of pesticides based on their toxicity.”¹⁷ Such a regulation indeed carries the force of law because it gives content to the authority FIFRA delegates to the EPA in section 136w(a)(1) to “prescribe regulations … [that] take into account the differences in concept and usage between various classes of pesticides,” with one such difference being levels of toxicity.¹⁸ The Third Circuit treats this toxicity class regulation as an analog to the preapproved label. However, the preapproved label forms a part of the pesticide registration process, which FIFRA expressly caveats, thus denying it the force of law.

A pesticide’s preapproved label is categorically different from a toxicity class regulation. The difference stems from section 136a(f)(2) of FIFRA. According to this section, registration is not a valid defense to a claim of misbranding. The fact of registration serves only as prima facie evidence of compliance with FIFRA misbranding standards. That is, a registered pesticide may very well lack a necessary warning statement that informs consumers of adverse effects the product could have on human or environmental health. Thus, a pesticide could comply with the EPA’s registration process while failing to comply with FIFRA’s misbranding provision. Indeed, the registration process is not a one-off but is instead continuous. Every 15 years, the EPA revisits each pesticide’s registration, either re-registering the product or requiring changes to the product in light of new studies and evidence. 

Furthermore, manufacturers are under a constant obligation to report new information regarding the safety of their products. As section 136d(a)(2) states, “[i]f at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, the registrant shall submit such information to the Administrator.”¹⁹ Given the difference between Bates’ example of an implementing regulation carrying the force of law and the EPA’s preapproval process, as well as the caveat Congress added to FIFRA such that the registration process only serves as prima facie evidence of FIFRA compliance, Schaffner errs in establishing the EPA’s preapproval process as the Federal Comparator for the case. As Hardeman puts it, the registration process is only a “rebuttable presumption that the pesticide and its label comply with FIFRA.”²⁰ Therefore, the proper Federal Comparator for the three cases examined is FIFRA’s misbranding provision. 

A final element of the Third Circuit’s argument in Schaffner meriting a response is the court’s discussion of prima facie compliance in section 136a(f)(2). The court agrees “that EPA registration cannot be ‘dispositive of FIFRA compliance.’”²¹ However, the court argues that the EPA’s preapproved label still “‘give[s] content to FIFRA’s misbranding standards’” because the EPA reviews the safety of the pesticide, ensures all proper warnings are on the label, and requires pesticide manufacturers to use only the preapproved label.²² However, much as it would like to, the Third Circuit cannot entirely disentangle the prima facie compliance clause from EPA regulations. The prima facie compliance clause prevents the preapproved label from carrying the force of law; the label is the product of a process that is not conclusive in determining whether the pesticide is misbranded. Thus, the registration process gives content to FIFRA misbranding by establishing a procedure, but at no point does that procedure override claims of harm caused by a pesticide. Indeed, it is this element of FIFRA that the Third Circuit neglects when pointing to Riegel as support for a preapproval process carrying the force of law. The Third Circuit is correct that the FDA’s medical device registration process is analogous to that of EPA pesticide registration, but the MDA does not have a prima facie compliance clause. Thus, the FDA has the final word on the safety of medical devices – but that is not the case with the EPA, whose process is determined to be mere prima facie evidence of FIFRA compliance.²³

Aside from the arguments presented in Schaffner, another potential critique of an anti-preemption stance could be that manufacturers are mandated to use the label approved by the EPA during the registration process. However, this critique misses the nuance of the registration process. As stated earlier, the process is not a one-off. Per FIFRA 136d(a)(2), manufacturers are obliged to report potential health threats, and they can apply for modification of their registration, including the warnings on their labels. At any time, Monsanto could have submitted a request to the EPA to add a cancer warning to its label, but it never did. The question of whether the EPA would have permitted the label change is immaterial. What matters is that, by applying for a label modification, Monsanto would have adhered to its obligations under FIFRA 136d(a)(2). 

A final common argument in favor of federal preemption of state failure-to-warn claims is that permitting such claims would create “a patchwork of state-enacted schemes in addition to federal law” as opposed to the “single, comprehensive regulatory scheme for all pesticide manufacturers” that Congress desired.²⁴ Indeed, Congress labeled section 136v(b) of FIFRA “Uniformity,” seemingly indicating the intent to unify regulatory frameworks. However, this final counterargument takes too broad a view of Congress’s purpose in establishing uniform regulations. In Bates, the Supreme Court looks to the history of tort litigation to assert that “Congress surely would have expressed its intention more clearly if it had meant to deprive injured parties of long available forms of compensation.”²⁵ The Supreme Court argues that, so long as state laws do not diverge from FIFRA’s requirements, they can provide material relief to injured parties, whereas federal law does not. Therefore, allowing state failure-to-warn claims strengthens rather than undermines FIFRA’s goal of a uniform pesticide regulatory scheme that best protects both consumer and environmental health. 

Policy Implications

In addition to being the proper legal interpretation given the text of FIFRA, this argument carries positive policy implications. The first is that denying federal preemption of state failure-to-warn claims allows states to protect their consumers. As mentioned earlier, there is no federal remedy for consumers impacted by FIFRA violations, so state laws can provide an avenue of redress. Furthermore, it is important to recognize that the EPA’s regulatory process is imperfect. Indeed, it is seriously flawed, as I shall discuss below, and permitting state failure-to-warn claims provides states the latitude to fill in the gaps in the EPA’s process. 

Beyond allowing states to protect their citizens, preventing federal preemption of state-failure-to-warn claims adjusts for the EPA’s inadequate registration process. The process does not confirm whether a pesticide is safe because it relies on industry-funded studies; Monsanto submitted its own studies when the EPA was evaluating the carcinogenicity of glyphosate, and Monsanto has a clear incentive to misrepresent the data. Meanwhile, the IARC used primarily peer-reviewed studies to conclude that glyphosate is a probable human carcinogen. It is difficult to place faith in the EPA’s conclusions about pesticide safety when it accepts industry studies rather than conducting its own studies or outsourcing them to unbiased investigators.²⁶ Thus, permitting state failure-to-warn claims under FIFRA corrects for a biased registration process.

Conclusion

Following the release of the IARC’s report in 2015 identifying glyphosate as a probable human carcinogen, thousands of plaintiffs have filed lawsuits against Monsanto, claiming that Roundup caused their cancer. In the past few years, a circuit split has emerged over the question of whether federal law preempts the plaintiffs’ state failure-to-warn claims. The Ninth and Eleventh Circuits have held that failure-to-warn claims can move forward, while the Third Circuit has ruled that they are preempted. The fundamental disagreement between the circuits is whether the EPA’s registration of Roundup under a label lacking a cancer warning carries the force of law. The Ninth and Eleventh Circuits argue that the registration process lacks the formality to be considered an act carrying the force of law, while the Third Circuit contends that pesticide manufacturers are mandated to use their preapproved label, and the registration process therefore carries the force of law. The operative clause in FIFRA that settles this dispute is section 136a(f)(2), which asserts that registration is not a defense for misbranding and EPA registration is only prima facie evidence of compliance with FIFRA’s misbranding provision. As EPA registration is prima facie evidence rather than conclusive evidence, the fact of an omitted cancer warning on Roundup’s preapproved label does not carry the force of law – the product can still very well be misbranded. Therefore, should the Supreme Court resolve this circuit split, it ought to rule that FIFRA does not preempt state failure-to-warn claims. Such a ruling would carry positive policy implications beyond the scope of the legal argument. Not only would it allow states to provide material relief for FIFRA violations, but it would also correct for a biased registration process whereby the EPA considers industry-funded studies rather than independent or government-led studies. The ruling would serve as a powerful signal to chemical giants that they must be proactive in protecting their consumers from the potential adverse health effects of their products.

Notes

1. Isabella Eakins, The Roundup Debate: Why the Supreme Court Should Rule that FIFRA Does Not Preempt Failure to Warn Claims and Recommendations for the EPA, 12 LSU J. of Energy L. & Resources. 296, 302 (2024).
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2. Failures to Warn Supporting Products Liability Legal Claims, Justia (2019), https://www.justia.com/products-liability/types-of-products-liability-claims/failure-to-warn/ (last visited Nov 15, 2024).
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3. Ronald V. Miller, Monsanto Roundup Lawsuit Update, Lawsuit Information Center (2024), https://www.lawsuit-information-center.com/roundup-lawsuit.html (last visited Nov 27, 2024).
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4.  7 U.S.C. § 136v(b).
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5. S. Douglas Fish, In Defense of FIFRA Preemption of Failure to Warn Claims, 12 Journal of Natural Resources & Environmental Law. 123, 125-126 (1996).
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6. 7 U.S.C. § 136a.
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7. 7 U.S.C. § 136j(a)(1)(E).
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8. 7 U.S.C. § 136(a)(q)(1)(G).
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9. 7 U.S.C. § 136a(f)(2).
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10. Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005).
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11. Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S. Ct. 999, 1001, 169 L. Ed. 2d 892 (2008).
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12. Hardeman v. Monsanto Co., 997 F.3d 941, 955 (9th Cir. 2021).
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13. United States v. Mead Corp., 533 U.S. 218, 230, 121 S. Ct. 2164, 2172, 150 L. Ed. 2d 292 (2001).
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14. Carson v. Monsanto Co., 72 F.4th 1261, 1265 (11th Cir. 2023).
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15. Schaffner v. Monsanto Corp., 113 F.4th 364 (3d Cir. 2024).
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16. Bates, 544 U.S. at 432.
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17. id. at 453.
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18.  7 U.S.C. § 136w(a)(1).
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19.  7 U.S.C. § 136d(a)(2).
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20.  Hardeman, 997 F.3d at 957.
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21. Schaffner, 113 F.4th at 396.
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22. id. at 397.
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23. Hardeman, 997 F.3d at 956.
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24.  Fish, supra note 5, at 132.
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25.  Bates, 544 U.S. at 432-33.
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26.  Eakins, supra note 1, at 315-316. ↩︎