Roundup: Monsanto’s Preemption Defense Fails

The U.S. Court of Appeals for the Ninth Circuit affirmed the $25 million verdicts in the Hardeman v. Monsanto Co. Roundup bellwether trial.  

Edward Hardeman claimed that his exposure to glyphosate (the active ingredient in Roundup) caused his non-Hodgkin’s lymphoma and that Monsanto failed to warn him about the risk of cancer from Roundup usage. A California jury awarded him $25 million and Monsanto appealed.

Monsanto’s Argument and the Preemption Defense

Monsanto argued that Mr. Hardeman’s failure-to-warn claim under California state law was preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) because the U.S. Environmental Protection Agency (EPA) had registered glyphosate, said it was not a carcinogen, and denied the need for a warning label for cancer.

This claim is based on the 2019 letter the EPA sent to glyphosate manufacturers saying that a warning label for cancer risks on glyphosate products was unnecessary. Monsanto said that, therefore, adding a warning label would be false and misleading.

Since states cannot impose any requirements for labeling or packaging in addition to or different from FIFRA, Monsanto argued that the 2019 letter from the EPA carried the “binding force of law” and the company would be violating federal law by putting a warning label for cancer on Roundup. Therefore, Monsanto argued that since Mr. Hardeman’s lawsuit is based on a state law that conflicts with guidance from a federal administrative agency, the lawsuit should not proceed. 

Monsanto’s argument is known as the preemption defense–commonly referred to as the “silver bullet defense.” The preemption defense is rooted in the Supremacy Clause of the U.S Constitution. The preemption doctrine is the idea that a “higher authority of law will displace law of a lower authority of law when two authorities come into conflict.” Therefore, when state and federal laws conflict, federal law preempts state law due to the Supremacy Clause.

U.S. Court of Appeals for the Ninth Circuit’s Ruling

The U.S. Court of Appeals for the Ninth Circuit disagreed with Monsanto’s argument that federal law (the EPA’s guidance) preempted the case brought using California state law’s failure-to-warn claims. 

The Court said that FIFRA does not expressly preempt Mr. Hardeman’s claims, because “FIFRA’s requirement that a pesticide not be misbranded is consistent with, if not broader than, California’s common law duty to warn.” The holding was also based on statutory language suggesting that the EPA’s approval of glyphosate “is not conclusive of FIFRA compliance.” The Court also noted that “mere inconsistency” between a state law duty and a manufacturer’s label is not sufficient to show preemption. 

Despite the EPA continuing to register glyphosate products, continuing to approve Roundup’s label which did not include a cancer warning, and issuing a letter directing glyphosate manufacturers to not warn of cancer, the Court determined that these actions “do not carry the force of law.” Therefore, they cannot establish preemption. 

Implications of the Court’s ruling mean that even though Roundup’s use of glyphosate is registered by the EPA and sold under a label approved by the EPA, the company could still be found liable for failing to warn consumers about a risk the EPA had instructed to omit from warning labels.

California State Law

In 2017, California designated glyphosate as a chemical known to cause cancer under Proposition 65. Under California law, this triggered a mandatory warning label to be added to glyphosate-containing products.

U.S. EPA on Roundup

FIFRA requires pesticide manufacturers to register their products with the EPA. Since 1974, the EPA has registered pesticides that contain glyphosate (the active ingredient in Roundup) and approved the warning label on Roundup that excludes cancer risks. 

After California’s state law in 2017 departed from the EPA’s position and designated glyphosate as a chemical known to cause cancer under Proposition 65, the EPA issued a letter challenging California. The EPA’s letter addressed all glyphosate registrants and told them to remove any Proposition 65 warning labels because the EPA considers the language that glyphosate is carcinogenic a violation of FIFRA’s prohibition against misbranded substances.

How GoldenbergLaw Can Help

If you or a loved one developed non-Hodgkin’s lymphoma after exposure to Roundupcontact the Roundup Attorneys at GoldenbergLaw today. You need a legal team that has the knowledge, compassion, and experience to fight for you. Our team at GoldenbergLaw has over 30 years of experience providing the Gold standard of advocacy to our clients. Contact us today for a free consultation!

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