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Failure-to-warn claims not preempted in Roundup case

Kate Halloran May 27, 2021

A federal environmental law does not preclude state law failure-to-warn claims against Monsanto Co. for its weed killer Roundup, the Ninth Circuit has ruled. In affirming a multimillion-dollar jury verdict for a plaintiff who alleged that Roundup caused his non-Hodgkin lymphoma, the court held that the federal law does not expressly or impliedly preempt the plaintiff’s claim that the defendant should have added a cancer warning to Roundup’s label. The court also found that the lower court properly admitted expert causation testimony under Daubert. (Hardeman v. Monsanto Co., 2021 WL 1940550 (9th Cir. May 14, 2021).)

The case was the first bellwether trial in the federal multidistrict litigation against Monsanto for claims related to its popular weed killer. The jury award included $75 million in punitive damages, which the district court later reduced to $20 million. Thousands of cases have been brought against the manufacturer, alleging that Roundup’s active ingredient, glyphosate, caused cancer. After the verdict in Hardeman, the defendant appealed on multiple grounds, including federal preemption, improper admission of expert testimony, and failure to show general causation. AAJ submitted an amicus brief in support of the plaintiff, and the Ninth Circuit affirmed the verdict.

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), pesticide manufacturers must register their products with the EPA and comply with certain labeling and packaging requirements. The statute provides that states may “not impose or continue in effect any requirements for labeling or packaging in addition to or different from” what FIFRA requires. Pesticides containing glyphosate started being registered with the EPA in 1974, and the agency has classified the ingredient as a possible human carcinogen since the 1980s. In 2015, the International Agency for Research on Cancer (IARC) released a report classifying glyphosate as a probable human carcinogen.

The Ninth Circuit considered several issues on appeal, including whether FIFRA preempts the plaintiff’s state law failure-to-warn claims and whether the lower court properly applied the Daubert standard to the plaintiff’s causation experts. First, it held that FIFRA does not expressly or impliedly preempt the state law claims. Relying on the two-part test from Bates v. Dow Agrosciences (544 U.S. 431 (2005)), the court considered whether California’s common law duty to warn involved a requirement for labeling or packaging and, if so, whether it imposed requirements in addition to or different from the federal requirements.


The court held that the state law duty to warn imposed requirements parallel to FIFRA’s misbranding provision, which requires a label to include “a warning or caution statement which may be necessary and if complied with . . . is adequate to protect health and the environment.” The state law duty to warn is “equivalent” to and “fully consistent” with the misbranding provision and therefore does not impose requirements beyond the federal law. In fact, the court concluded, the federal misbranding provision is broader than what California law requires because it provides that a product is misbranded under FIFRA if the manufacturer did not warn of any “known or knowable” health risk or risks that a “reasonably prudent” manufacturer would have known about.

The court also rejected the defendant’s argument that FIFRA preempts the state law claims under Wyeth v. Levine (555 U.S. 555 (2009)) because the EPA continued to register Roundup without requiring that a cancer warning be added to its label. While the EPA is “highly involved” in the registration process, the court noted, label approval is simply one step in the overall registration process and is not determinative of FIFRA compliance. Finding otherwise would render pointless the statute’s misbranding provision and other requirements to report information about “unreasonable adverse effects” to the agency after label approval. And there was not “clear evidence” under Merck Sharp & Dohme Corp. v. Albrecht (139 S. Ct. 1668 (2019)) that the EPA would have rejected a label change.

Nor did PLIVA, Inc. v. Mensing (131 S. Ct. 2567 (2011)) apply—the court was not persuaded that the defendant could not unilaterally change Roundup’s label to comply with California law. The underlying regulatory framework here differed significantly from the FDA’s drug labeling regulations at issue in Mensing. For one, FIFRA makes manufacturers responsible for drafting their labels, and once a label is approved, manufacturers have an ongoing duty to adhere to label requirements and to draft label changes and submit them to the EPA for approval when necessary. Approval is more of a rubber stamp so long as the label change does not violate FIFRA, the court noted. And in certain circumstances, manufacturers can make label changes without prior approval from the EPA if the agency is notified of the label change—which the agency has allowed for other pesticides and cancer warnings. Therefore, it was not impossible for the defendant to alter Roundup’s label to add a cancer warning.

Another area the court analyzed on appeal was whether the lower court properly applied Federal Rule of Evidence 702 and the Daubert standard for expert testimony. The court disagreed with the defendant’s characterization of the circuit’s application of Daubert as “an outlier” that is more flexible than other circuits. The court explained that it is appropriate to leave the weight and credibility of an expert’s testimony to the jury—with the court fulfilling its function as a gatekeeper for the testimony’s reliability under Daubert, not as a fact-finder. It also clarified that experts may use their clinical experience to support opinions about differential diagnoses when testifying, and stated that it is sufficient for clinical experience to supplement an expert’s review of a plaintiff’s records and the relevant medical literature, including epidemiological, animal, and cell studies. The court also held that the lower court did not err in admitting the IARC classification, had properly denied the defendant’s motion for judgment as a matter of law, and that the evidence supported awarding punitive damages.

Oakland, Calif., attorney Leslie Brueckner, one of the plaintiff’s attorneys on appeal, said, “It’s impossible to overstate the importance of this decision for victims of Roundup—and for access to justice. This is the first—and, to date, only—appellate ruling in the country on this issue. It will affect the rights of millions of current and future victims of this dangerous herbicide. . . . Decisions like this one are the only thing that can put pressure on Monsanto to put a cancer warning on Roundup. That’s what makes this victory so important. The civil justice system is often the only way to hold powerful actors accountable for their wrongdoing. When juries speak out often enough, and loudly enough, companies are forced to listen—and change their ways.”

Washington, D.C., attorney Matt Wessler, who prepared AAJ’s amicus brief, said, “In unanimously rejecting Monsanto’s bid to preempt the important health and safety law claims against it, the Ninth Circuit sent an unmistakable message to companies that they cannot use vague notions of federal preemption to avoid accountability for their dangerous and deceptive conduct. It is only when Congress speaks clearly on preemption that a federal court can wipe away state law. Here, because Congress did not, companies like Monsanto cannot escape liability for their wrongdoing.”