Supreme Court Could Decide Fate of Monsanto/Bayer Roundup Cancer Suits

Scientists, Ex-EPA executive, anti-glyphosate activist offer clashing opinions in interviews with The Epoch Times

A customer shops for Roundup products at a store in San Rafael, Calif., on July, 9, 2018. (JOSH EDELSON/AFP via Getty Images)

On Dec. 13, the Supreme Court asked the Solicitor General to offer the United States’ views on “Monsanto v. Hardeman”—the latest move in what may be a landmark case for multibillion-dollar litigation linking the herbicide Roundup to non-Hodgkin lymphoma, if the high court agrees to review the case.

After a call for the views of the solicitor general, that Justice Department official will often respond with a brief commenting on whether the Supreme Court should agree to review the case. The solicitor general’s office didn’t respond to a request by The Epoch Times for comment by press time.

Monsanto, which was acquired by the German chemical company Bayer in 2018, filed its petition after a 9th Circuit panel ruled in favor of California resident Edwin Hardeman, who claimed his non-Hodgkin lymphoma resulted from exposure to Roundup.

Ninth Circuit Judge Ryan D. Nelson, a Trump appointee, found that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) didn’t preempt California’s law, under which Roundup and other products containing glyphosate must feature warnings about that ingredient’s reported cancer risk.

While the state of California maintains that glyphosate is carcinogenic, the U.S. Environmental Protection Agency (EPA), which enforces FIFRA, maintains that glyphosate isn’t likely to cause cancer in humans.

Monsanto’s petition to the Supreme Court challenges the 9th Circuit’s ruling on preemption. It also argues that the 9th Circuit admitted low-quality expert opinions on glyphosate and cancer, deviating from the practices of other appellate courts and violating Federal Rule of Evidence 702.

Monsanto specifically disputes Dr. Dennis Weisenburger’s testimony that Hardeman’s non-Hodgkin lymphoma was caused by glyphosate and not linked to his earlier diagnosis of Hepatitis C, known to be associated with non-Hodgkin lymphoma.

Weisenburger didn’t respond to a request by The Epoch Times for comment by press time.

An American flag waves outside the U.S. Department of Justice Building in Washington on Dec. 15, 2020. (Al Drago/Reuters)

Bayer responded warmly to the Supreme Court’s invitation to the solicitor general.

“The company has been very selective in its settlement approach since filing its Petition for a Writ of Certiorari in Hardeman. Now that the Supreme Court has requested input from the Solicitor General in this case, we will not entertain any further settlement discussions with plaintiff lawyers that are representing a substantial number of Roundup™ claims,” a Bayer spokesperson told The Epoch Times via email.

In a separate interview, the spokesperson told The Epoch Times that it has resolved roughly 98,000 out of more than 125,000 claims linking non-Hodgkin lymphoma to Roundup. While those settled claims wouldn’t be affected if the high court ruled in favor of Monsanto, the more than 25,000 outstanding claims could be, according to the spokesperson.

While the spokesperson wouldn’t say how much the company had paid to date, they said the company has established a $9.6 billion provision for current litigation and, in July, a $4.5 billion provision for future cases.

U.S. District Court Judge Vince Chhabria. (United States District Court for the Northern District of California)

In addition, the company took a $2 billion provision for class action, which still stands, even after the company withdrew its agreement in conjunction with an unfavorable ruling from U.S. District Court Judge Vince Chhabria, who said elements of Bayer’s proposal were “clearly unreasonable.”

The Bayer spokesperson told The Epoch Times that a substantial chunk of its $16.1 billion reserves for settling claims could be affected by the Supreme Court’s decision.

Notably, the Supreme Court case could come soon after multiple California jury verdicts that found Roundup wasn’t responsible for a claimant’s non-Hodgkin lymphoma, according to Reuters.

California’s law, as well as Hardeman’s suit, hinges in part on a major 2015 monograph from the International Agency for Research on Cancer (IARC), which classified glyphosate as “probably carcinogenic to humans.”

A spokesperson for IARC declined to comment on Monsanto v. Hardeman but stated that its results and evaluation from 2015 are still valid.

Monsanto’s petition argues that EPA and other regulators around the world have maintained a “global consensus” that glyphosate doesn’t cause cancer.

In 2019, after California classified glyphosate as carcinogenic, EPA issued a letter stating that California’s warning language constituted a “false and misleading statement.”

When asked about “Monsanto v. Hardeman,” the EPA told The Epoch Times that “as this is pending litigation, we have nothing to add.”

Henry Darwin, who served as acting deputy administrator and chief operating officer of the EPA during the Trump administration, told The Epoch Times in an exclusive interview that he hopes the Supreme Court will take the case.

The Supreme Court of the United States in Washington on June 30, 2018. (Charlotte Cuthbertson/The Epoch Times)

“When EPA says that there’s no cancer risk associated with this consumer product, that shouldn’t be up for challenge by an individual state or, worse yet, by an individual scientist,” Darwin said.

“My fear is that if California is allowed to have its own conflicting opinion about something like glyphosate, it’s a slippery slope that could lead to an eroding of our confidence in EPA as a country.”

While “Monsanto v. Hardeman” effectively pits California’s law against the federal government’s standards, Darwin doesn’t believe that a ruling in favor of Monsanto would undermine the proper authority of states.

“I’m a true believer in state’s rights if the state has a right that’s unique to the state,” he said. “In this instance, we’re talking about a commercial product that’s being sold throughout the country. There’s nothing unique about its use or application in California, and Congress has made it pretty clear that through FIFRA [the Federal Insecticide, Fungicide, Rodenticide Act] it is EPA’s responsibility to set the appropriate safety standards and evaluations associated with this type of consumer product.”

Monsanto’s petition to the Supreme Court has garnered supporting briefs from the U.S. Chamber of Commerce, the Washington Legal Foundation, and the pesticide trade organization CropLife America, among other organizations.

“The quality of decision-making in federal court hinges on the ability and willingness of trial-court judges to prevent unreliable ‘scientific’ expert evidence from ever being admitted into evidence. Unless the Supreme Court arrests the Ninth Circuit’s pattern of excusing judges from this gatekeeping duty under Rule 702, the federal judiciary’s ability to produce fair and just results will be eroded,” Cory Andrews, general counsel and vice president of litigation for the Washington Legal Foundation, told The Epoch Times in an email.

A view of the 9th U.S. Circuit Court of Appeals in San Francisco on June 12, 2017. (Justin Sullivan/Getty Images)

In its petition, Monsanto describes the IARC’s classification as a “slender reed” for claims against Monsanto.

Not all scientists agree.

John Spinelli, professor emeritus of epidemiology, biostatistics, and public health practice at the University of British Columbia, was a co-author of a 2001 study that linked non-Hodgkin lymphoma to the use of herbicides. It was cited in IARC’s 2015 monograph on glyphosate.

“I am in total support of that conclusion of the IARC review,” Spinelli told The Epoch Times.

However, Paolo Boffetta, an epidemiologist and professor across multiple disciplines at the Icahn School of Public Health at Mount Sinai, told The Epoch Times that early studies linking glyphosate to non-Hodgkin lymphoma, such as Eriksson et al.’s study of almost 2,000 Swedish adults, have seen less support from more recent research.

His 2021 meta-analysis concluded there was no significant association between exposure to glyphosate and overall non-Hodgkin lymphoma risk.

Yet in an exclusive interview with The Epoch Times, he stressed that there are many different subtypes of the cancer, making it hard to rule out a potential link at a more granular level.

German pharmaceutical giant Bayer in Berlin on Nov. 24, 2010. (JOHN MACDOUGALL/AFP/GettyImages)

“Whether we can say that for each individual subtype of lymphoma we have strong evidence that there is no association, I don’t think we should say that,” Boffetta said.

He confirmed to The Epoch Times that he previously acted as a consultant for Monsanto, although not on anything related to glyphosate.

Other scientists who have authored research linking glyphosate with cancer either declined to comment or didn’t respond to requests for comment from The Epoch Times.

Jeffrey Smith, an anti-glyphosate activist who leads the Institute for Responsible Technology, told The Epoch Times in an exclusive interview about “Monsanto v. Hardeman” that Monsanto has a history of undermining scientists who are critical of it.

He cited emails in the “Monsanto Papers” concerning Gilles-Éric Séralini, a French molecular biologist whose research examined the toxicity of Roundup.

Roundup products for sale at a hardware store in San Rafael, Calif., on July, 9, 2018. (JOSH EDELSON/AFP/Getty Images)

One 2009 email released in the papers showed that the editor of a journal that had received one of the scientist’s manuscripts allowed it to be reviewed by a Monsanto executive, William F. Heydens.

“With your help the following final decision has been reached: Reject (allow resubmission),” the editor, Gio Batta Gori, wrote to Heydens.

A spokesperson for Bayer told The Epoch Times that the “Monsanto Papers” and similar materials hadn’t been enough to convince regulators in the United States and many other countries, including in the European Union, to consider Roundup or glyphosate carcinogenic.

The spokesperson cited the European Food Safety Agency’s 2017 statement on the “Monsanto Papers.”

“The nature of the information contained within the ‘Monsanto papers’ was serious enough for EFSA to investigate their significance in relation to the EU assessment of glyphosate. Following this investigation, EFSA can confirm: that there are no grounds to suggest that industry improperly influenced the EU assessment of glyphosate; and that the role of industry and of other actors in the process was carried out according to standard procedures,” EFSA wrote.

The Environmental Protection Agency in Washington on Dec. 12, 2018. (Samira Bouaou/The Epoch Times)

Smith said Monsanto has undermined the EPA’s approval process.

He cited a letter from the late EPA employee Marion Copley to EPA herbicides administrator Jess Rowland as Copley was dying of breast cancer. In it, she accused Rowland of playing “political conniving games with the science to favor the registrants.” She also wrote that “[it] is essentially certain that glyphosate causes cancer.”

Bayer’s spokesperson defended the EPA, stating that the agency said its analysis of the cancer risks from glyphosate “was ‘more robust’ and ‘more transparent’ than IARC’s review.”

Smith said a preemption precedent favoring Monsanto would be “a tragedy and a travesty,” given what he sees as Monsanto’s undue influence over the EPA.

“They’re now hiding behind that and hoping that the Supreme Court and that the Department of Justice blindly follow a law and give the EPA determination far more validity than it deserves,” he said.