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US EPA supports Bayer in glyphosate cancer verdict appeal

The US EPA has thrown its support behind Bayer legacy company Monsanto in the glyphosate case, saying that the judgment of the US District Court for the Northern District of California awarding damages against the company should be dismissed.

The US District Court for the Northern District of California erred when it denied Bayer legacy company Monsanto’s motion to dismiss a case by a cancer victim accusing the company of failing to warn him about the carcinogenic potential of glyphosate herbicide, says the US EPA in a brief filed with the US Court of Appeals for the Ninth Circuit. Laying out specific reasons for why the court was in error, the EPA says that the judgment of the district court should be reversed and the case should be either dismissed or, in the alternative, remanded.

The case pertains to the conclusion by a jury in March 2019 that Monsanto should have warned California resident Edwin Hardeman that its Roundup herbicide can cause cancer. The jury hit the company with $75 million in punitive damages as well as $5.2 million in compensatory damages. The punitive damages were reduced in July from $75 million to $20 million by US District Judge Vince Chhabria, who concluded that although Monsanto “deserves to be punished" based on the evidence presented at the trial, the size of the jury's award was "constitutionally impermissible”.

Bayer filed its opening brief earlier in December seeking to overturn the $25 million verdict. The stakes are especially high for the appeal as it is the first at the federal level involving a challenge to the label for Monsanto’s Roundup.

“The label is the law”

In its brief, the EPA says that when regulating pesticides under the US Federal Insecticide Fungicide and Rodenticide Act (FIFRA), the Agency has long declared that “the label is the law”. “Every time EPA reviews and approves the label for a registered pesticide, it is making federal law,” it declares. Roundup is registered under FIFRA and its EPA-approved label does not contain a cancer warning. The Agency points out that it is unlawful for manufacturers and sellers to make claims on their labels that differ from what the EPA approves.

The Agency points out that while states can generally restrict the sale or use of pesticides, they cannot impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under the FIFRA. The plaintiff in the case claimed that Monsanto failed a legal duty to make additional statements on the label about alleged cancer risks associated with Monsanto’s glyphosate — “cancer risks that EPA has for decades concluded science does not support”.

The EPA stresses that it reviewed and approved Monsanto’s glyphosate label. Referring to California’s decision to add glyphosate to its Proposition 65 (Prop 65) list (of chemicals known to cause cancer) in June 2017, the EPA says that the plaintiff asserted that safety labeling requirements exist under California law in addition to and different from that required, reviewed, and approved by EPA. “Plaintiff is wrong and his lawyers sailed directly into pre-empted territory in how they opted to try this case.”

California cannot "dictate federal policy"

In August, in response to California's Proposition 65 listing of glyphosate, the EPA issued a letter to all glyphosate registrants stating that labels for products containing glyphosate cannot include claims that the herbicide causes cancer. "It is irresponsible to require labels on products that are inaccurate when EPA knows the product does not pose a cancer risk," it stated. “We will not allow California’s flawed program to dictate federal policy,” said EPA Administrator Andrew Wheeler.

In its current brief, the Agency says that following California’s Prop 65 listing of glyphosate in 2017, many manufacturers that had been registered to use glyphosate reached out to it for guidance. Some specifically sought the EPA’s approval to amend their product labels to satisfy Prop 65 and the Agency did approve a limited number of applications allowing the addition of a Prop 65 glyphosate cancer warning to pesticide labels when requested. “These label-change approvals, however, were erroneous because the proposed edits warned of a cancer risk that, according to EPA’s assessment, does not exist,” the Agency says. “As a result, such a warning instead constituted prohibited misbranding.” That was the reason for it to issue a letter to all registrants in August.

Other cases

In addition to the federal case under appeal, Bayer has lost the two other cases that have made it to trial. In August 2018, a California jury awarded a former school groundskeeper some $289 million in a similar case. A state judge subsequently reduced the damages to $78 million, concluding that the punitive damages exceeded constitutional limits. In 2019, a second state jury, also based in California, awarded an elderly couple $2 billion in damages in May. That was subsequently slashed by a judge to under $87 million. Bayer has appealed both those rulings. 

In September, a coalition of agricultural interests, food producers and pesticide manufacturers urged a federal judge to strike down the state of California's decision to add glyphosate to Prop 65.

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