Background
Bayer, the parent company of Monsanto, which owns the popular herbicide Roundup, faced a legal setback after a jury awarded a staggering $2.25 billion, with $2 billion in punitive damages. This is the largest verdict awarded against Roundup so far, in five years of litigation. The plaintiff, John McKivison, asserted that his two-decade long use of Roundup resulted in his diagnosis of non-Hodgkin’s lymphoma. McKivison’s lawyers emphasized that the jury’s punitive damages award serves as a resounding call for corporate change within Bayer.
Monsanto released a statement announcing its intention to appeal the verdict, citing the damages as “unconstitutionally excessive.” The company asserted that the jury’s decision contradicts a recent Roundup case where a court ruled in their favor by granting a summary judgment motion. Monsanto has a history of facing lawsuits related to its product. Since at least October 2021, the company has been embroiled in legal battles over Roundup allegedly causing cancer. However, the majority of rulings have favored Monsanto, with courts determining insufficient evidence linking Roundup to plaintiff’s cancer. In fact, the company has been successful in ten of the last sixteen Roundup cases tried, though some of the losses incur massive verdicts, such as a $1.5 billion dollar verdict in Missouri.
Credit: Wannapik Studio
Litigation Facts
John McKivison, a Pennsylvania citizen, developed non-Hodgkin's lymphoma, a form of cancer, after using Roundup products for personal use more than thirty times since 2006. In his complaint, he alleged that his cancer was caused by the chemical glyphosate, the main ingredient in the various Roundup products. According to the complaint, glyphosate is the most used herbicide in the world, with 3.5 billion pounds of it used in America since 1974, and 15.4 billion more pounds used worldwide. Because of this, it has contaminated the food chain and is ubiquitous throughout the air, water, and soil in areas where it is used. Monsanto is the world’s leading producer of glyphosate.
Interestingly, Mr. McKivison’s complaint alleged that Monsanto participated in a misinformation campaign convincing government agencies and individuals that glyphosate-based products are safe. As part of the alleged misinformation, Mr. McKivison offered up two instances of fraudulent glyphosate health-and-safety testing, uncovered by the Environmental Protection Agency (EPA). First, a laboratory hired by Monsanto was found by an EPA audit to have performed routine falsifications of data, resulting in multiple convictions of fraudulent laboratory practices against top executives at the laboratory. Second, Monsanto hired a different laboratory company to perform studies on herbicides including Roundup, which again resulted in multiple convictions of fraudulent laboratory practices. Additionally, Mr. McKivison alleged that Monsanto had ghostwritten several studies downplaying safety concerns about glyphosate by publishing through third parties without disclosing their significant role in those studies. Finally, Mr. McKivison referred to a suit against Monsanto by the New York Attorney General for false and misleading advertising of Roundup products, which included such phrases as “safer than table salt” and “practically non-toxic.” These allegations are hefty, but were apparently persuasive to the jury, perhaps helping to explain why the complaint was somewhat light on scientific authority.
Scientific Controversy
Roundup’s primary active ingredient, glyphosate, is surrounded by some scientific controversy. Glyphosate is an herbicide that doesn’t discriminate––it kills most plants. In 2015, the International Agency for Research on Cancer (IARC) classified glyphosate as “probably carcinogenic to humans.” Additionally, in 2019, researchers at the University of Washington concluded that glyphosate use raises the risk of non-Hodgkin lymphoma, the same cancer Mr. McKivison was diagnosed with. However, despite these findings, various agencies including the EPA have not established a definitive link between glyphosate and cancer.
Mr. McKivison’s main evidence for establishing a causal link between his health condition and glyphosate was the classification of glyphosate as a Probable Human Carcinogen by the IARC. The IARC classifies chemical agents into four categories, those being known, probable, possible human carcinogens, and not classified. The complaint described, in depth, the rigorous research process used by the IARC, and the various types of data incorporated into their reports. It also underscored various findings that the IARC had made about glyphosate. Glyphosate was found to be widespread through air, water, and food. Glyphosate was found in the urine of agricultural workers, indicating absorption. Research indicated that glyphosate had harmful effects on the genes, hormones, and enzymes of exposed mammals. Glyphosate damaged the DNA and chromosomes of mammals, as well as human cells in vitro. It also had harmful effects on human gut microbiome, which contains enzymes which Roundup is designed to target in plants. Finally, the IARC report underlined a study which showed some association between glyphosate and some types of cancers, including variations of leukemias.
Mr. McKivison also described some indications that the EPA believed glyphosate to be a carcinogen and harmful to humans, and alleged that Monsanto used contacts within the EPA and ties to the government to suppress negative findings from being published by the EPA. Mr. McKivison supported this claim by highlighting studies which the EPA chose not to draw from, as well as a fact sheet describing glyphosate as dangerous which the EPA published in 2015 and retracted in 2016.
However, Monsanto has some contentions about the legitimacy of these claims. Primarily, Monsanto maintains that its product is not carcinogenic, pointing to the IARC being the sole source classifying glyphosate as a carcinogen, and a possible one at that. There have been rigorous scientific studies finding no significant genetic damage caused by glyphosate, suggesting that if damage is caused by it, then it would likely only be because of a combination with other compounds. Various other health authorities also recognize a lack of health risks associated with glyphosate, with IARC being the only major organization to claim otherwise.
While research is never conclusive, and there is certainly the possibility for the scientific consensus regarding glyphosate to change, it seems that currently most of the scientific community agrees that serious health effects from glyphosate have yet to be discovered. How, then, could Mr. McKivison win such a large verdict? The answer lies in the low evidentiary standard for determining mass chemical tort cases such as these.
Evidentiary Standard
A toxic tort (e.g., a mass chemical tort) has four elements which must be proven: exposure to a toxic substance, the defendant’s negligence or fault, causation, and damages. The most important and fiercely litigated element is causation––whether the company producing the allegedly harmful substance was the one that caused the plaintiff’s health condition. In Pennsylvania, and in California, the causation must only be proven by a preponderance of the evidence. That means that it must only be more likely than not that the company’s chemicals caused the health condition, or, in other words, 51% likely. Because of this, for the plaintiff to succeed, they only need to present enough scientific evidence to persuade the jury, rather than what would be needed to prove a correlation scientifically. This means that even if the consensus in the scientific community leans one way, a dissenting voice could be sufficient evidence to lead a jury to approve a massive verdict.
Here, the IARC was more or less the sole load-bearing pillar for Mr. McKivison’s assertions about the dangers of glyphosate. Whether or not the jury ruled ‘correctly,’ it is interesting to consider the precedent this case sets with regard to lawsuits and the attitude towards the scientific method in courtrooms.
Monsanto’s Five-Point Plan and Conclusion
Monsanto does not believe that its product is carcinogenic and is confident in its ability to appeal the verdict successfully, given its success in winning the majority of the Roundup cases that went to trial.
Monsanto explicitly mentions a five-point plan. First, it aims to secure a favorable ruling from the U.S. Supreme Court on whether state-based failure-to-warn claims are preempted by federal law. Second, the company intends to take cases to trial. Third, Monsanto is in the process of manufacturing the development of a new herbicide formula solely to minimize litigation risks. Fourth, it established a voluntary claims administration program to directly address eligible individuals. Finally, the company has launched a dedicated webpage providing access to scientific studies concerning its glyphosate products.
Additionally, Monsanto plans to appeal this ruling. Monsanto’s main contention is that a federal law, called the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), regulated by the EPA, preempts states from making their own rules about cancer warnings. Under FIFRA, “a State shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under” FIFRA. In other words, if a state law imposes requirements on labeling or packaging pesticides, that state law is overridden unless it is fully consistent with FIFRA.
Whether the entire ruling is overturned on appeal, or just the $2 billion in punitive damages, remains to be seen. Perhaps the court upholds it, which will put Bayer group in a tricky situation moving forward.
*The views expressed in this article do not represent the views of Santa Clara University.