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Supreme Court Could Decide Fate Of Monsanto/Bayer RoundUp Cancer Suits

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by Tyler Durden
Thursday, Dec 23, 2021 - 02:00 AM

Authored by Nathan Worcester via The Epoch Times (emphasis ours),

On Dec. 13, the Supreme Court asked the Solicitor General to offer the United States’ views on “Monsanto vs. Hardeman”—the latest move in what could be a landmark case for multibillion-dollar litigation linking the pesticide RoundUp to non-Hodgkin’s lymphoma, if the Supreme Court agrees to review the case.

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

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 Epoch Times has reached out to the Solicitor General for comment.

Monsanto, which was acquired by the German chemical company Bayer in 2018, filed its petition after a Ninth Circuit panel ruled in favor of California resident Edwin Hardeman, who claimed his non-Hodgkin’s 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) did not 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 glyphosate is not likely to cause cancer in humans.

Monsanto’s petition to the Supreme Court challenges the Ninth Circuit’s ruling on preemption. It also argues that the Ninth 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’s lymphoma was caused by glyphosate and not linked to his earlier diagnosis of Hepatitis C, known to be associated with non-Hodgkin’s lymphoma.

The Epoch Times has reached out to Dr. Weisenburger for comment.

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’s lymphoma to RoundUp. While those settled claims would not be affected if SCOTUS ruled in favor of Monsanto, the 25,000+ outstanding claims could be, according to the spokesperson.

While the spokesperson would not say how much the company had paid to date, they stated the company has established a $9.6 billion provision for current litigation and, in July 2021, a $4.5 billion provision for future cases.

In addition, the company took a $2 billion provision for class action, which still stands despite the fact that 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 was not responsible for a claimant’s non-Hodgkin’s 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 its results and evaluation from 2015 are still valid.

Monsanto’s petition argues EPA and other regulators around the world have maintained a “global consensus” that glyphosate does not 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 vs. 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 under Trump, told The Epoch Times in an exclusive interview why he hopes the Supreme Court will take the case.

“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,” he later added.

While “Monsanto vs. Hardeman” effectively pits California’s law against the federal government’s standards, Darwin does not 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,” said Darwin. “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,” said Cory Andrews, General Counsel and Vice President of Litigation for the Washington Legal Foundation, in an email to The Epoch Times.

A view of the Ninth 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 coauthor on a 2001 study that linked non-Hodgkin’s lymphoma to the use of pesticides. 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.

But 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’s 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’s 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, though not on anything related to glyphosate.

Other scientists who authored research linking glyphosate with cancer either declined to comment or did not 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 what is so far an exclusive interview on “Monsanto vs. 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.

One 2009 email released in the papers showed 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 had not 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, who wrote to EPA pesticides 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 EPA 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.

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