Commentary By
Lawrence S. Ebner, ALF Excutive Vice President & General Counsel
The Supreme Court needs to end the plague of Roundup personal injury litigation, which during the past 10 years has infected our civil justice system and undermined federal regulation of pesticides. As the Atlantic Legal Foundation explained in a recent amicus brief, the pending certiorari petition in Monsanto Company v. Durnell (No. 24-1068) affords the Justices an important and timely opportunity to do exactly that.
Roundup’s active ingredient, glyphosate, is the nation’s most widely used agricultural herbicide. For more than half a century, glyphosate cost-effectively has controlled weeds on a wide variety of crops, thereby boosting growers’ productivity, lowering food costs for consumers, and enabling environmental friendly conservation practices such as no-till farming.
Like all pesticide active ingredients, glyphosate is comprehensively regulated by the U.S. Environmental Protection Agency (EPA). To obtain and maintain EPA approval, pesticide registrants (Monsanto, now Bayer, in the case of glyphosate) spend tens of millions of dollars on extensive toxicology, environmental, and other types of scientific studies, which EPA scientists and regulators meticulously and continually review. These EPA-required studies, which are conducted in accordance with strict scientific protocols, govern EPA’s determination whether to register (or to continue to register) a pesticidal active ingredient such as glyphosate. Equally important, the studies help EPA decide what specific health and safety warnings should be included on each pesticide product’s nationally uniform product labeling for the protection of farmers, applicators, and other agricultural workers, and to provide clarity and consistency for consumers. Warnings can be added to a pesticide’s labeling only with EPA’s prior approval.
EPA repeatedly has determined, based on its review of all available scientific data and literature on glyphosate, including a widely criticized monograph prepared by the World Health Organization’s “International Agency for Research on Cancer,” that glyphosate can be used safely and does not cause cancer in humans. Every regulatory body throughout the world that has conducted its own independent assessment of glyphosate has reached the same conclusion.
In an August 2019 “Dear Registrant” letter, EPA not only reaffirmed its conclusion that glyphosate is unlikely to cause cancer in humans, but also rejected a glyphosate cancer label warning, which a California “right-to-know” law would have required for Roundup products despite EPA’s no-cancer-warning-is-warranted determination. In fact, EPA’s extraordinary letter notified glyphosate registrants that such a cancer warning on glyphosate product labeling would be false and misleading, and thus render the product misbranded in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the nation’s principal pesticide regulatory statute.
To maintain nationally uniform labeling for each registered pesticide product, FIFRA includes an “express preemption” provision. It prohibits a State from imposing “any requirements” for a pesticide’s labeling that are “in addition to or different from” the labeling requirements imposed by EPA under FIFRA. See 7 U.S.C. § 136v(b). Although each State shares authority with EPA to regulate pesticide sale and use, 7 U.S.C. § 136v(a), only EPA has the statutory authority to regulate the content of pesticide labeling.
In a 2005 decision, Bates v. Dow AgroSciences LLC, 544 U.S. 431, the Supreme Court held that FIFRA’s preemption provision bars failure-to-warn claims that challenge the adequacy of the warnings on a pesticide’s EPA-approved labeling. The only exception identified in Bates to the FIFRA preemption provision’s expansive language is where state law imposes requirements that are “parallel” or “equivalent” to FIFRA’s general misbranding standards. Those standards prohibit, among other things, distributing a pesticide whose labeling contains statements that are false and misleading, or that does not contain adequate health and safety warnings.
Bates explains that the parallel-requirements exception merely means that state law can provide a remedy for violation of federal labeling requirements. For example, state law can provide a remedy for an individual injured by a registrant’s failure to provide a label warning specifically required by EPA. A State, however, cannot second-guess EPA’s labeling determinations by requiring a label warning—such as a cancer warning—where, as in the case of glyphosate, EPA has determined that such a warning is scientifically unwarranted, and would be false and misleading.
During the past decade personal injury lawyers throughout the United States have filed more than 180,000 failure-to-warn claims alleging that individuals have developed cancer as a result of using, or being exposed to, the glyphosate active ingredient in Roundup herbicide products. While many of those claims have been resolved, almost 70,000 such claims still are pending. These claims, mostly filed in plaintiff-friendly state trial courts, largely ignore EPA’s determination that glyphosate does not cause cancer in humans, and that a cancer label warning not only would be scientifically unwarranted, but also false and misleading and thus render Roundup products misbranded in violation of federal law.
To circumvent FIFRA preemption, personal injury lawyers contend that the narrow exception identified in Bates for “parallel” state requirements broadly applies where, as in virtually every State, there is a general tort duty for manufacturers to warn about the alleged dangers of their products. Their theory, based on a misreading of Bates, is that FIFRA preemption does not apply to Roundup failure-to-warn claims because a general state-law duty to warn is parallel to FIFRA’s general misbranding prohibition against distributing pesticides with labels that contain inadequate warnings.
This convenient misinterpretation of the Bates parallel-requirements exception is legally flawed. It completely ignores the active ingredient-specific manner in which EPA actually regulates pesticides. It also ignores EPA’s carefully considered, repeated determinations that a glyphosate cancer label warning would be scientifically unwarranted and a violation of FIFRA. And it conflicts with Congress’ determination that each pesticide product be distributed with nationally uniform labeling regulated solely by EPA based on scientific data.
Unfortunately, a significant number of federal and state courts have taken the easy way out by rejecting FIFRA preemption of Roundup failure-to-warn claims based on the personal injury bar’s self-serving misreading of Bates. The opinion of the Missouri Court of Appeals in the Durnell v. Monsanto case is typical. The Missouri Supreme Court would not even review that intermediate appellate court’s facile and superficial rejection of FIFRA preemption.
But there now is an unmistakable split of authority among federal courts of appeals on whether FIFRA preempts Roundup failure-to-warn claims. It is difficult to imagine a more clear-cut case of FIFRA preemption: EPA has squarely rejected the very same cancer label warning for Roundup on which tens of thousands of pending Roundup failure-to-warn claims are premised.
The pending certiorari petition urging the Supreme Court to review Durnell and address preemption of Roundup failure-to-warn claims affords the Court a perfect opportunity to clean up this jurisprudential mess.
There is even more at issue in the Roundup litigation than the critical and unresolved question of FIFRA preemption. The personal injury bar has expended millions of dollars to advertise and promote its Roundup litigation. TV, radio, and other promotional activities not only troll for potential Roundup “victims,” but also are intended to bias large numbers of potential jurors who may be called upon to decide Roundup cases. This raises fundamental questions of fairness, as well as clogs court dockets with cases that should be dismissed as preempted. Taxpayers and consumers are the ultimate victims of this sort of litigation abuse.
In addition, Roundup failure-to-warn claims seriously undermine the authority and credibility of EPA—the expert federal agency that Congress not only has designated to regulate pesticides based on sound science, but also to be the sole authority for determining what health and safety warnings should, and should not, appear on a pesticide product’s labeling. Allowing thousands of lay jurors throughout the United States to decide for themselves, contrary to FIFRA preemption, whether Roundup labeling should have contained a cancer warning, despite EPA’s expert determination that it should not, conflicts with congressional intent and breaches the separation of powers.
The Supreme Court should grant certiorari in Monsanto v. Durnell and hold that FIFRA expressly preempts Roundup failure-to-warn claims.
