Plaintiffs rested their case on Friday at the end of week two in the on-going Hardeman trial, the first of three bellwether trials in California federal court alleging that Monsanto’s glyphosate-containing Roundup weed killer causes cancer.

What is Glyphosate?

Glyphosate is a man-made chemical, first synthesized by a Swiss chemist in 1950. It was independently discovered by scientists at Monsanto in the United States in 1970, when the company asked its scientists to develop an effective herbicide compound for consumers to use as a weed killer. The product was brought to market in 1974 under the brand name Roundup.

It was quickly realized that glyphosate was one of the most effective weed killing agents on the market, as it inhibits photosynthesis in plants, which ensures that plant cells are not able to regenerate, thereby killing the plant that glyphosate is applied to.  Roundup soon became one of the most widely used weed killing agents by consumers for use on residential and commercial properties, by landscaping companies, and the government (primarily for use by groundskeepers at public schools). In the agricultural sector, glyphosate’s use was not so readily adapted, as it was so effective that it killed not only weeds, but the crops themselves. It was not until 1996 with the advent of genetically modified crops that were resistant to glyphosate that the product became widely used on farms. Genetically modified crops led to a 15-fold increase in the use of glyphosate in the agricultural sector. According to the U.S. Environmental Protection Agency (EPA), in 2007, glyphosate was the most used herbicide in the United States agricultural sector, with 180 to 185 million pounds applied, the second-most used in home and garden with 5 to 8 million pounds used, and the U.S. government applied 13 to 15 million pounds in industry and commerce.

Is Glyphosate Harmful To Human Health?

Glyphosate studies have been conducted for years prior to the Johnson verdict in July of 2018. The majority of the initial studies were conducted on rats. For example, one trial in the United Kingdom, in which rats were fed low levels of glyphosate throughout their lives, found that the chemical contributed to a higher risk of nonalcoholic fatty liver disease, a condition in which fat accumulates in the liver and contributes to inflammation and scarring of the tissue. Studies have also been conducted on other mammals, such as rabbits, aquatic fauna, plants, and soil bacteria.

Based on these studies, in 2013 a review of over 1,000 epidemiological studies, animal studies, and in vitro studies were reviewed by the German Institute for Risk Assessment. It found that “no classification and labelling for carcinogenicity is warranted” and did not recommend a carcinogen classification.  The results were given to the European Food and Safety Authority (EFSA) and in November of 2015, the EFSA published its own conclusion of the available studies, stating that glyphosate was “unlikely to pose a carcinogenic hazard to humans.”

In the U.S., in 1993, the Environmental Protection Agency (EPA) studied whether glyphosate was hazardous to human health and concluded that the chemical was not carcinogenic. In its review, the EPA considered a “worst case” dietary risk model of an individual eating a lifetime of food derived entirely from glyphosate-sprayed fields with residues at their maximum levels. This model indicated that no adverse health effects would be expected under such conditions. In 2015, the EPA initiated another review of glyphosate’s toxicity and in 2016 reported that glyphosate is likely not carcinogenic.

However, in March 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) concluded its own analysis of the available epidemiological studies and found that glyphosate , is “probably carcinogenic to humans.” “For the herbicide glyphosate , there was limited evidence of carcinogenicity in humans for non-Hodgkin lymphoma,” the report stated. “The evidence in humans is from studies of exposures, mostly agricultural, in the USA, Canada, and Sweden published since 2001. In addition, there is convincing evidence that glyphosate also can cause cancer in laboratory animals.”

The IARC report was criticized for not considering all of the available literature on glyphosate. However, IARC admitted that it disregarded any studies that had any connection to the agricultural industry (e.g., studies funded by the industry). This was in contrast to prior government agencies, who considered such studies while adjusting for potential biases. Nevertheless, it was the IARC statement regarding the “probable” carcinogenicity in humans that sparked the glyphosate litigation. The cases were ultimately consolidated on a single docket, where now over a thousand plaintiffs have pending lawsuits alleging that glyphosate in Roundup week killer caused their cancer.

Hardeman Trial

The Hardeman trial is currently in phase one of trial, which is expected to conclude this week. Previously, during pre-trial motion practice, Judge Chhabria granted Monsanto’s request for a bifurcated trial with phase one of trial to address causation and, if needed, phase two addressing liability and damages. The bifurcation was meant to limit phase one to scientific evidence without the jurors hearing about Monsanto’s alleged conduct seeking to influence the scientific record and knowledge of certain scientific findings.

Last week, jurors heard from plaintiff, Edward Hardeman, who testified regarding his use of Monsanto’s Roundup to kill weeds and poison oak on his 56-acre property for more than 25 years. He testified that during this use, he sometimes felt the mist from the spray blowing onto his skin. Hardeman was diagnosed with non-Hodgkin lymphoma in February of 2015.

The jury did not hear any evidence last Monday due a juror being ill. Instead, there was a discussion with the attorneys and Judge Chhabria regarding evidence plaintiff was seeking to introduce at trial based on Monsanto “opening the door” by contesting that there existed evidence of genotoxicity with glyphosate herbicides. Judge Chhabria agreed that plaintiff would be allowed to present evidence regarding the “Parry Report,” a report authored by a consultant hired by Monsanto in the 1990s in which he recommended that Monsanto do additional studies to “clarify potential genotoxic activity” of glyphosate.

Hardeman Trial – Plaintiff’s Case

In addition to hearing from plaintiff, the jury also heard from plaintiffs’ pathologist, Dr. Weisenberg, who walked jurors through scientific evidence that he said shows Monsanto’s Roundup is a “substantial cause” of cancer in humans. A key part of Monsanto’s defense is their argument that Hardeman’s cancer was caused by his hepatitis C, his weight and his age. However, Dr. Weisenberg rejected this argument, testifying that when Hardeman was treated and cured of hepatitis years earlier, any cells damaged by the virus would have died off and if Hardeman were to get lymphoma as a result, he would have gotten it when he had the infection, not several years later. Monsanto’s attorney gained some concessions from Dr. Weisenberg on cross-examination, eliciting testimony that Dr. Weisenberg could not completely rule out that Hardeman had chronic hepatitis B for decades, which could have contributed to his non-Hodgkin lymphoma.

Hardeman Trial – Monsanto’s Defense

Monsanto began putting on their defense on Friday, presenting videotape deposition testimony of Dr. William Reeves, who provided an overview of the glyphosate and its benefits, and a short video clip of deposition testimony of Dr. Donna Farmer, who worked for Monsanto for 27 years and is currently employed by Bayer (Bayer acquired Monsanto last year). The jurors heard from Dr. Mucci in person. Dr. Mucci, a cancer epidemiologist from Harvard, presented testimony regarding the lack of a causal association between Roundup and non-Hodgkin lymphoma. A focus of Dr. Mucci’s testimony was discussion of a 2018 Agricultural Health Study, a cohort study with over 50,000 participants, many of whom are pesticide applicators. The AHS, which concluded that no association was apparent between glyphosate and malignancies overall, including non-Hodgkins lymphoma, is a key piece of Monsanto’s defense. Dr. Alexandra Levine, a hematologist and oncologist, took the stand briefly on Friday and will continue her testimony this week as phase one of the Hardeman trial continues.

Hardeman Trial – Week Ahead and Impact Beyond California

Now that plaintiffs have rested and Monsanto has started presenting their defense, we can expect to hear more from Monsanto’s experts this week as the debate on the cause of plaintiff’s illness and the science regarding glyphosate continues.

The high-profile nature of this trial and the glyphosate-litigation in general is already having an impact beyond California with a claim having recently been filed in Worcester, Massachusetts in which Wendy Burdett alleges that her at-home use of Roundup for more than 13 years led to her diagnosis of non-Hodgkin’s lymphoma.  Burdett alleges that despite IARC’s classification in 2015, Monsanto knew of the hazards of glyphosate for decades and did not warn. Burdett goes even further and claims that Monsanto “relied upon flawed industry-supported studies designed to protect [their] economic interests rather than [Burdett] and the consuming public.”

CMBG3 Law LLC has represented clients in products liability matters, especially with respect to allegedly toxic chemicals. We provide the most current legal advice to our clients by staying on top of developments in science, medicine, and regulations regarding a wide variety of substances and products used by consumers every day. If you have any questions or would like more information, please contact John Gardella (email him or 617-279-8225) or Michaela Lancer (email her or 617-279-8216).