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Proven science is company's main defense in Roundup lawsuits

Regulatory approvals are powerful evidence the plaintiffs’ claims just don’t add up and that glyphosate is safe when used as directed.

Turn on the television or radio these days and you will catch commercials urging you to call a toll-free number if you or a loved one used Roundup, or glyphosate, herbicide and were diagnosed with Non-Hodgkin's Lymphoma.

The commercials offer the “compensation you deserve” with some promising you won’t pay a dime until your case is settled. Three jury verdicts in California, one in federal court and two in state court, have ruled in favor of plaintiffs who claim they contracted Non-Hodgkin's Lymphoma after using Roundup.

In an exclusive interview with Farm Press, Rakesh Kilaru, a partner with the Washington, D.C., law firm Wilkinson Walsh, which is defending Monsanto, the maker of Roundup, said the three rulings are under appeal.

In 2018, Monsanto was acquired by Bayer.

Powerful Evidence

Kilaru felt Monsanto will be successful in appealing the rulings in all three lawsuits. The EPA, working with the Justice Department, has filed court papers supporting Monsanto’s position that glyphosate, the active ingredient in Roundup, poses no cancer risk.

“We think the regulatory approvals are very powerful evidence the plaintiffs’ claims just don’t add up and that this product is safe when used as directed and has been a real benefit for people around the globe,” Kilaru said.

In the appeals, as well as pending lawsuits, Kilaru said Monsanto is emphasizing that EPA and other regulatory bodies across the globe have deemed glyphosate safe when used according to label directions. Regulatory bodies in Europe, Australia, New Zealand and Canada have also deemed Roundup safe.

“We are continuing to defend the product across litigation. The issues that are raised in the appeal are issues which are going to be raised in the future trials as well. One of the biggest issues in the case as a whole is the fact the plaintiffs are claiming there should be a cancer warning on a product that has repeatedly been approved by the United States government without any such warning,” Kilaru said.

In legal briefs, Monsanto has emphasized that the EPA has consistently approved the sale of glyphosate without a cancer warning and has stated that including such a warning on the label would render the product misbranded. Monsanto has emphasized any state-imposed cancer warning would be in addition to or different from federal law and is expressly preempted by federal law which has precedent over state law.

“The science the plaintiffs have been bringing forward in this litigation is what I like to call ‘made for courtroom science,’” Kilaru said. “Science across the board and powerful studies have supported the safety of this product. But what happens in the courtroom is the plaintiffs and their experts pick and choose little pieces of the studies to construct a story that doesn’t present the full picture.”

In its arguments, Kilaru said Monsanto is emphasizing that in legal matters experts “are not allowed to bring junk science and cherry-picked science into the courtroom.” Kilaru said this point was emphasized to juries and is a core feature of the appeal of the three cases that reached jury rulings.

“EPA has repeatedly affirmed the safety of this product. The agency also recently issued a letter saying it would be misbranding and a misleading label if the label were to reflect a cancer warning because EPA doesn’t believe this claim is supported by science,” Kilaru said.

The Outlier

Also in the Farm Press interview, Dr. Liza Dunn, M.D., medical affairs lead for Bayer, related evidence and data from various agencies and experts that show glyphosate is safe when used according to the label.

She noted the California Medical Association, the California Hospital Association and California Dental Association have all filed amicus briefs in the case. 

“The EPA and other regulatory agencies across the globe are made up of hundreds, if not thousands, of scientists who looked at hundreds, if not thousands, of studies across all sorts of disciplines in terms of the environment and in the terms of public health,” Dunn said.

More than 800 risk assessments and regulatory studies support the product. Large epidemiological studies show no link between glyphosate and cancer. The only assessment linking glyphosate to Non-Hodgkin's Lymphoma comes from the International Agency on Research on Cancer, or IARC, part of the United Nations’ World Health Organization. 

Dunn said the IARC assessment is an outlier that contradicts the entire body of known science on glyphosate. Roundup has been approved for use in roughly 160 countries.

Dunn explained that IARC is basically a committee made up of 17 people who take a different approach from other scientific bodies and do a hazard assessment instead of risk assessment.

“When you consider NHL and think about a toxin causing cancer, the same toxin should cause the same cancer over and over again,” Dunn explains. “We know, for example, that asbestos causes mesothelioma, which is a very rare cancer of the lining of the lung. NHL is actually not one cancer. It’s around 60 different extraordinarily rare cancers that are put in a basket. Glyphosate is not associated with any one of those cancers or the whole disease category overall. There is just no link,” she said.

The Cases

The IARC assessment is the source for Roundup court cases in California.  The first lawsuit against Roundup was in August 2018, when Dewayne Johnson, a groundskeeper in the San Francisco area, was awarded $289 million by a jury for contracting NHL. Johnson attributed the disease to being exposed to Roundup on the job and claiming there were inadequate warnings for cancer on the label. The $289 million award was reduced by the court to $78 million.

The Johnson case was followed by two court cases, also in the San Francisco Bay area. In March 2019, Edwin Hardeman was awarded $80 million by a six-person jury, and in April 2019, in Pillod vs. Monsanto, plaintiffs were awarded $2 billion.

In the Hardeman case, the $80 million reward, which included $75 million in punitive damages, was reduced to $25 million by U.S. District Judge Vincent Chhabria to comply with Supreme Court precedent restricting the size of punitive damage awards. The $2 billion Pillod reward was also reduced by the court to $87 million.

Buying Attention

Kilaru said most of the lawsuits were filed by individuals in the lawn and garden sector instead of the agricultural sector. Driving the lawsuits is the barrage of advertising on radio and television paid for by plaintiff attorneys.

Bayer officials estimate the plaintiff attorneys spent around $4.5 million in advertising in the first quarter of last year, upped that to $21 million in the second quarter of last year while the California trials were occurring, upping advertising spending to $87 million through October. Kilaru believes when the final numbers are tabulated for advertising in 2019 by plaintiff attorneys, the money spent will approach $100 million.

Kilaru said all the advertising and all the lawsuits are an example of mass torts, which are different than class action lawsuits.

Dunn is confident Roundup will remain on the market because it is an effective product and has been safely used for 45 years.

“Pesticides are heavily regulated. Regulatory agencies do a battery of tests that take up to 10 years before a pesticide can go to the market. They use rigorous testing protocols. The public can rest assured that EPA and other regulatory agencies around the world have public health interests as their main priority,” she said.

“If you use these products according to label, you’re not going to have any adverse health effects. Pesticides are really critical for public health and really critical for nutrition,” she said. “Customers and farmers can be certain that Roundup and glyphosate-based herbicides are absolutely safe and not carcinogenic.”

TAGS: Regulatory
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