Roundup®: Will EPA Have the Last Word on Glyphosate?

Long-time practitioners in agricultural product litigation remember when the doctrine of preemption served as a meaningful defense to many claims of personal injury asserted by plaintiffs from the use of crop protection products. That world largely came to an end in 2005 with the United States Supreme Court’s opinion in Bates v. Dow Agrosciences LLC, 544 U.S. 431, which held that state laws and tort rulings that were parallel to federal law were not preempted. Since Bates, the preemption defense has taken a back seat in most crop protection personal injury cases.

But based on a brief filed this last week by Monsanto, the Hardeman Roundup^® (glyphosate) appeal pending before the U.S. Court of Appeals for the Ninth Circuit may inject new life into preemption failure to warn arguments. Recent personal injury lawsuits in California over Monsanto’s Roundup^® herbicide have resulted in eye-popping verdicts and punitive damages awards in cases that even the presiding federal judge concedes relied on expert opinions that were “borderline,” “equivocal,” and “sometimes [in] the realm of junk science.” In Hardeman v. Monsanto Co., a federal court jury awarded the plaintiff, who claimed to have contracted non-Hodgkin’s lymphoma from using Roundup^® to kill weeds in his yard, more than $5 million in compensatory damages and $75 million in punitive damages (later reduced by the court to $20 million) based on Monsanto’s purported failure to warn him of the alleged carcinogenic effects of Roundup^®. More than 5,000 additional cases claiming personal injuries from exposure to Roundup^® are pending in federal courts. 

The wave of Roundup^® litigation started in 2015 after the International Agency for Research on Cancer (IARC) issued a “hazard classification” that listed glyphosate, the active ingredient in Roundup^®, as “probably carcinogenic to humans.” IARC’s classification is at odds with the findings of virtually every national regulatory agency that has looked at glyphosate, including the United States Environmental Protection Agency (EPA), the European Union, and health agencies in Australia, New Zealand, Germany, Japan and Canada. EPA reaffirmed its determination that glyphosate is “not likely to be carcinogenic to humans” as recently as December 2017. Nevertheless, IARC’s listing automatically led to glyphosate being placed on California’s list of “Prop 65” chemicals “known to the State of California to cause cancer” and would have required a warning label on products containing glyphosate. The inclusion of glyphosate on California’s Prop 65 list undoubtedly encouraged plaintiffs’ claims that Monsanto failed to warn users of carcinogenic potential of Roundup^®, notwithstanding the repeated findings of EPA and other national agencies that glyphosate is unlikely to cause cancer. Plaintiffs’ experts and attorneys in Hardeman and other Roundup^® litigation have relied heavily on the IARC hazard classification in testimony and arguments to the jury, and the trial judge rejected several attempts by Monsanto to assert preemption to defeat the failure to warn claims.

However, in August 2019, subsequent to the Hardeman verdict, EPA issued a letter to all companies that had registered products containing glyphosate. The letter informed them that, in light of its determination that glyphosate was not likely to be carcinogenic to humans, EPA considered the inclusion of a Prop 65 cancer warning on glyphosate products to be a “false and misleading statement.”¹ Because the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) prohibits “misbranding” of pesticides and requires EPA approval of pesticide labels, EPA announced that it would not approve any glyphosate product label that contained a “false and misleading” cancer warning, and that any such warning needed to be removed from existing labels. A federal court had already enjoined California from enforcing the Prop 65 labeling requirement. Nat’l Ass’n of Wheat Growers v. Zeise, 309 F. Supp. 3d 842 (E.D. Cal. 2018).

Monsanto, in turn, is relying heavily on the EPA letter in its recently-filed Hardeman appellate brief. Monsanto argues that the plaintiff’s failure to warn claim was impliedly preempted by EPA’s clear position on warnings. Implied preemption applies to bar state law tort claims where compliance with both federal law requirements and a proposed state law duty would be impossible. See, e.g., Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1676, 1678 (2019). Likewise, Home Depot recently moved to dismiss a lawsuit alleging that the failure to provide a cancer warning on Roundup^® violated California’s Unfair Competition Law on impossibility grounds, also citing EPA’s August 2019 letter. Weeks v. Home Depot U.S.A., Inc., Case No.: 2:19-cv-06780-FMO-AS (C.D. Cal.). Both Monsanto and Home Depot point to the EPA August 2019 letter as “clear evidence” that EPA would never have approved a cancer warning for Roundup^®. The companies argue that as a result it would have been impossible for them to comply with their FIFRA obligation not to “misbrand” Roundup^® with a “false and misleading” cancer warning, and also comply with plaintiffs’ posited state law duty to warn Roundup^® users of the purported cancer risk. 

The outcome of these two cases could have a significant impact on Roundup^® litigation. In the absence of a duty to warn, there can be no tort liability for failing to include a cancer warning on the Roundup^® label. EPA’s August 2019 letter to glyphosate registrants leaves plaintiffs little room to argue that EPA would have approved a cancer warning on Roundup^®. The EPA pronouncement in fact goes even further by asserting that any such warning would constitute “misbranding” under FIFRA because EPA considers such claims of carcinogenicity “false and misleading.” Under federal law, no product could be sold with such a warning on it. Companies who sell agricultural products and their counsel will no doubt be watching these two cases intently to see if EPA’s position on carcinogenicity will carry the day and foreclose tort cases seeking different warnings.