The United States Supreme Court issued its decision in Monsanto v. Durnell, holding state law failure-to-warn claims were preempted by federal law. [Read Opinion here.] Justice Kavanaugh wrote the majority opinion. Justice Thomas wrote a concurring opinion, and Justice Jackson authored a dissent in which Justice Gorsuch joined.
Photo via Jonathan Cooper
Quick Summary
I know some of you are not going to read the lengthy explanation included below. Here is the quick summary of the decision:
Mr. Durnell sued Monsanto in state court claiming failure-to-warn because Roundup does not contain a cancer warning. Monsanto argued these claims were preempted by federal law.
The Supreme Court decided in a 7-2 opinion written by Justice Kavanaugh that state law failure-to-warn claims are preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Environmental Protection Agency (EPA) considers all of the potential health and environmental risks prior to approving a herbicide label. FIFRA includes a preemption provision prohibiting states from imposing any labeling requirements “different from or in addition to” those required by FIFRA. Here, Mr. Durnell’s failure-to-warn claim would require a cancer warning that is not included on the label approved by the EPA under FIFRA. The Court found this requirement to be in addition to or different from the FIFRA requirement, so the state law failure-to-warn claim was preempted by federal law.
For a medium-length summary from SCOTUSblog, click here.
Background
Monsanto is a subsidiary of Bayer AG that manufactures and distributes Roundup, a glyphosate-based herbicide. In 1974, the EPA first registered glyphosate-based herbicide products and approved Roundup’s label with no cancer warning. The EPA has repeatedly re-evaluated glyphosate and has concluded it is unlikely to cause cancer.
John Durnell filed suit in Missouri state court against Monsanto claiming after using Roundup for 20 years, he was diagnosed with non-Hodgkin’s lymphoma. One of his specific legal claims was a state law claim for failure-to-warn in which he alleged Monsanto failed to include a cancer warning on Roundup’s label.
In response, Monsanto argued his state law failure-to-warn claim was preempted by FIFRA. Specifically, Monsanto explained that federal law requires it to use the EPA-approved label for Roundup, which does not include a cancer warning. Mr. Durnell’s state law claim would impose a labeling requirement “in addition to or different from” the label required by the EPA under FIFRA and, therefore, FIFRA expressly preempts Mr. Durnell’s failure-to-warn claim.
Lower Court Rulings
At trial, the jury sided with Mr. Durnell on his failure-to-warn claim, rejecting Monsanto’s preemption argument. They awarded Mr. Durnell $1 million in damages. The Missouri Court of Appeals affirmed the verdict.
Monsanto sought review from the United States Supreme Court on the issue of preemption of the state law failure-to-warn claim. Federal courts of appeal and state courts have come to different conclusions on this issue, and the United States Supreme Court agreed to hear the case to resolve the circuit split on this question.
Applicable Law
FIFRA requires pesticides be registered with the EPA. Before issuing a registration, the EPA conducts a review of the pesticide and its proposed label that manufacturers are required to submit with their registration application. A proposed label must include any necessary warning statements.
FIFRA mandates a label cannot be “misbranded.” A “misbranded” label is one that contains any “false or misleading “ statement or that does not contain a “warning or caution statement which may be necessary and adequate to protect health and the environment.” The statute defines “protect health and the environment” as protecting against “any unreasonable adverse effects on the environment” including “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.”
The EPA has issued regulations to carry out this mission, including regulations that specify the required content and label placement of precautionary statements like cancer warnings.
In summary, before registering a pesticide, the EPA evaluates the pesticide and its proposed label, and must make a number of determinations, including the proposed label contains all warnings necessary and adequate to protect human health and the environment, and the label is not false or misleading. EPA approving a registration means the EPA believes the pesticide is not misbranded, it does not contain any false or misleading information, and it does not omit a necessary warning.
Once a pesticide is registered and the label is approved, the EPA requires the manufacturer to use the approved label. Changes to the label must be approved by the EPA. Failure to use the approved label can result in criminal and civil penalties for the manufacturer. Even after the label is approved, manufacturers are required to inform the EPA about additional information related to adverse effects of their products, and the EPA may also request additional information from the manufacturer.
Finally, FIFRA includes a preemption clause titled “Uniformity” that prohibits States from imposing “any requirements for labeling or packaging in addition to or different from those required under FIFRA.
Supreme Court Opinion
The United States Supreme Court reversed in a 7-2 decision authored by Justice Kavanaugh.
State law claim is a labeling requirement.
The Court noted the law makes clear and the parties agree state law tort duties constitute state labeling requirements. Mr. Durnell’s failure-to-warn claim is based on a common law failure-to-warn claim, which qualifies as a labeling requirement because those rules set the standard for product labeling.
The question, then, is whether the Missouri failure-to-warn claim, which would require a cancer warning on the Roundup label, imposes a labeling requirement that is “in addition to or different from” the requirements under FIFRA. The Court said the answer was yes.
FIFRA sets forth the pesticide labeling approval process. A pesticide manufacturer must use the EPA-approved label or face potential criminal or civil fines. The EPA has repeatedly approved the Roundup label without a cancer warning. The Missouri failure-to-warn claim would require a cancer warning be added to the label. That requirement, the Court held, is “in addition to” and “different from” Monsanto’s federal-law labeling requirements.
Precedent reinforces the Court’s conclusion.
The Court cited Bates v. Dow Agrosciences LLC, which included an example of how FIFRA’s preemption clause operates. If EPA required a “caution” designation on a label, and a state law failure-to-warn claim targeted the label for saying “caution” rather than “danger,” the state law claim would be preempted by FIFRA. Bates distinguished the example from the claims in Bates, which were based on the product’s efficacy. The EPA does not review efficacy claims as part of the registration process, but it does thoroughly review safety claims. Thus, safety claims are preempted, while efficacy claims are not.
In Durnell, the Court explained, safety claims are involved. The EPA’s registration determination reflects EPA’s judgment that the label is not false, misleading, and is not lacking necessary warnings. Thus, any claims that would impose additional or different labeling requirements are preempted.
The Court turned to Riegel v. Medtronic, a case involving the Medical Device Amendments (MDA), which function nearly identically to FIFRA’s preemption clause. Like the EPA is required to do under FIFRA, the MDA requires the FDA to consider safety requirements to approve devices. Thus, state law claims based on safety-related concerns are preempted by the MDA. Allowing Mr. Durnell’s state law tort claim to overcome FIFRA preemption would impact more than just pesticides and herbicides but would impact the MDA and several other statutes containing nearly identical preemption language.
The Court rejected Mr. Durnell’s arguments.
Next, the Court rejected Mr. Durnell’s four arguments.
First, Mr. Durnell argued the state law failure-to-warn claim, like FIFRA itself, simply requires manufacturers to include adequate warnings to protect human health and not to include false or misleading statements. The Court held that argument “operates at far too high a level of generality and disregards the central and comprehensive role that EPA performs in making labeling determinations under FIFRA’s registration provisions.” FIFRA expressly affords preemptive force to federal requirements imposed under FIFRA. These constitute “requirements” under federal law.
Second, Mr. Durnell claimed that the EPA’s regulations and procedures for registering pesticide labels exceed its authority under FIFRA. The Court said this was “incorrect” and noted FIFRA expressly directs the EPA to register pesticides and to determine if labeling complies with FIFRA’s requirements.
Third, Mr. Durnell argued because the statute provides no registration shall be construed as a defense for the commission of any other offense under FIFRA, registration cannot serve as a defense to a state tort suit. The Court said this argument would “effectively erase FIFRA’s express preemption clause.” The text of this provision applies only to defenses for FIFRA violations, not state tort violations. Further, Mr. Durnell’s reading of the regulations was incorrect. The regulations required a manufacturer to use the EPA-approved label. Mr. Durnell said Monsanto should have unilaterally changed its label to include a cancer warning. The EPA does not bring misbranding actions when a manufacturer is using an approved label. Instead, only if new safety information came to light, the EPA may gather additional information and take action if it were to find the current label misleading. That did not happen here. Additionally, Monsanto was not relying merely on the fact that its product is registered as complete defense; instead, Monsanto was relying on the EPA’s determination that cancer warnings are not required for Roundup.
Fourth, Mr. Durnell raised concern over new safety information that arises after the EPA has registered a label. There is, the Court explained, a process for manufacturers to provide additional safety information, and they are required to do so. Additionally, the EPA keeps abreast of new safety developments and is able to request additional information about a product. Additionally, third parties can bring this type of information to the EPA for consideration.
Conclusion
FIFRA demands uniformity and expressly preempts state labeling requirements that are “in addition to” or “different from” federal labeling requirements. Mr. Durnell’s state law failure-to-warn claim would require a cancer warning on Roundup’s label. This warning would be “in addition to” or different from” the label required by the EPA. FIFRA expressly preempts Mr. Durnell’s claim. The case was reversed and remanded.
Concurring Opinion
Justice Thomas wrote a concurring opinion. He joined the Court’s opinion in full but wrote separately to address “some of the underlying constitutional infirmities” of FIFRA.
First, he said FIFRA exceeds the commerce clause because, in his view, the Commerce Clause “does not allow Congress to regulate agriculture or manufacturing activities entirely separate from commerce.” He pointed out FIFRA regulates not only manufacturers, but consumers as it addresses who may own and how they may use products that were purchased locally at a store down the street for use in his or her backyard. He believes FIFRA is “unconstitutional in many applications.”
Second, he said FIFRA “raises questions about Congress’ ability to delegate core legislative power to the EPA.” Congress improperly delegated core legislative power to the EPA.
Third, he wrote agency action cannot preempt state law as it is beyond the scope of the Supremacy Clause.
Dissenting Opinion
Justice Jackson authored a lengthy dissenting opinion, which was joined by Justice Gorsuch.
Failure-to-warn claim is equivalent to FIFRA requirements
Justice Jackson explained Mr. Durnell’s failure-to-warn claim is not “in addition to or different from” FIFRA’s mandates. Instead, she said, it is “equivalent” to FIFRA’s key labeling requirement, the misbranding prohibition. Further, she noted the state law claim does not conflict with any other FIFRA requirement because the EPA’s registration of a pesticide and approval of its label does not create a labeling requirement under FIFRA.
The dissent explained FIFRA expressly limits States’ authority to regulate pesticide labels, but it does not eliminate that authority. Instead, it preempts only those state requirements for labeling or packaging that are “in addition to or different from” the federal requirements. Thus, equivalent state law claims—or claims where a violation of the state law also constitutes a violation of FIFRA—are not preempted.
The dissent reasoned the “requirements” under FIFRA’s misbranding provision and Missouri state law failure-to-warn claim are the same. The EPA did not set specific requirements for label warnings related to chronic risks like cancer. Absent federal law requirements, “a state law duty that imply parallels FIFRA’s misbranding prohibition is not preempted.”
She offered three examples. Assume a state mandated pesticides causing moderate skin irritation to bear the word “WARNING.” That law would be preempted by FIFRA because the EPA regulations require labels for products causing moderate skin irritation to bear the word “CAUTION.” That state labeling requirement is different from (and conflicts with) the EPA regulation.
On the other hand, if a state seeks to hold a manufacturer liable for failing to label a pesticide with the same warning words federal regulations require, the application of the state law would not be preempted because the state requires the same warning, not one that is different or in addition to the FIFRA requirements.
Lastly, suppose a State wants to ensure pesticides are properly labeled and contain all necessary warnings to protect against unreasonable risk to humans and the environment. The State either enacts a statue that makes manufacturers liable for failing to provide these necessary warnings, or it relies on the existing tort regime to reach the same result. Either way, the state law scheme “merely duplicates” FIFRA’s necessary and adequate warning requirements and is, therefore, not preempted.
Based on this understanding, the dissenting justices believe “it is easy to see that Durnell’s failure-to-warn claim…does not trigger preemption under FIFRA.” Missouri’s failure-to-warn law punishes the sale of unreasonably dangerous products like pesticides without adequate warning of the danger. This has the same practical effect as FIFRA’s misbranding prohibition. Mr. Durnell’s claim does not impose any labeling requirement in addition to or different from FIFRA. The standards prescribed by federal and state law are equivalent.
FIFRA’s misbranding provision remains a requirement.
FIFRA provides registration of a herbicide is prima facie evidence its label complies with FIFRA requirements. But prima facie evidence is not conclusive evidence. Thus, when faced with a misbranding charge, registration is not a complete defense. Considering this, a pesticide may be registered but still misbranded. The dissent explained it is the combination of the registration process and the misbranding prohibition that dictates the contents of the label.
The dissent pointed to a situation in 1999 when the EPA approved a Roundup label that did not include any warning the product could leak. The EPA determined, after the label was approved and the product was registered, that the product could leak or spray onto the user when used in accordance with the label. The EPA imposed civil penalties on Monsanto for distributing or selling a misbranded product, even though they were using the approved label.
FIFRA’s misbranding provision remains a requirement manufacturers must follow even after the EPA’s registration of a pesticide. A state law failure-to-warn claim that imposes identical requirements as the misbranding provision is not preempted.
The dissent also noted the misbranding provision makes clear that registration alone does not create a labeling requirement under FIFRA. The product’s label must be both approved and not misbranded. The focus, then, is not merely on the label as approved by the EPA, but on the label as required under FIFRA, which includes the misbranding requirement. Thus, FIFRA’s misbranding provision applies to pesticides. When a state-law requirement, such as a failure-to-warn claim parallels that misbranding requirement, the state law requirement can apply to the registered pesticide.
Monsanto’s position cannot be squared with Bates and Riegel involved in a different statute.
Next, the dissent explained Bates makes clear, contrary to Monsanto’s argument, that a registered pesticide can be misbranded. Critically, Bates explained the difference between a registration decision for a particular pesticide and the statutory language and regulations that apply to misbranding standards. The dissenting justices also read Bates distinction between claims of efficacy and claims of safety as irrelevant, essentially claiming it was dicta and not critical for the primary holding. Riegel, the dissent explained, involves a completely different statute that has no misbranding provision like the one at issue in FIFRA. Additionally, Riegel did not involve parallel claims, such as the ones here.
The dissent would reject the implied preemption claim as well.
Although the majority did not address the implied preemption claim since it ruled the claim was expressly preempted, the dissent did consider and reject the implied preemption argument. Monsanto can “easily comply with both federal and state law by stopping sales of Roundup. Under FIFRA it is unlawful to sell a misbranded pesticide. Under Missouri failure-to-warn law, manufacturers have a duty not to sell products made unreasonably dangerous by inadequate warnings. Far from being incompatible, both federal and state law require Monsanto to stop selling its pesticide if the label lacks adequate warnings.” Additionally, to keep marketing the product, Monsanto could simply add a cancer label. To the extent it needs approval from the EPA to do so, which the dissent contests, it could simply submit an application for the amended registration.
