Monsanto Asks Ninth Circuit to Dismiss $20M Roundup Verdict

(Credit: Bayer AG)

SAN FRANCISCO (CN) — Roundup manufacturer Monsanto urged three Ninth Circuit judges on Friday to overturn a jury’s verdict finding the weed killer caused a California man’s cancer, arguing that the federal judge overseeing the trial allowed the jury to hear from an unreliable expert witness.

Former U.S. Solicitor General Seth Waxman, now a civil litigator with WilmerHale, argued on behalf of the Bayer-owned agrochemical company.

“The trial in this case never should have been held,” he said.

U.S. District Judge Vincent Chhabria held a week’s worth of hearings in 2018 on whether the science supporting claims that Roundup causes cancer in humans was strong enough to present to a jury.

In July 2018, Chhabria ruled that expert opinions offered by three of plaintiff’s experts on a causal connection between exposure to Roundup’s main ingredient glyphosate and cancer were “shaky but admissible,” advancing the first federal bellwether jury trial centered around Ed Hardeman, a Sonoma County man who was diagnosed with non-Hodgkin lymphoma in 2015. 

Chhabria split the trial into two parts, the first focusing on causation and the second on determining Monsanto’s liability and Hardeman’s damages. 

In 2019, a six-person jury awarded Hardeman $75 million in punitive damages and $5 million in compensatory damages for past and future pain and suffering. Chhabria later reduced the punitive damages award by $50 million, finding it excessive.

Waxman said Friday that the jury should have never heard from pathologist Dr. Dennis Weisenberger, whose testimony did not pass the gatekeeping standard for admitting expert testimony that the U.S. Supreme Court enshrined in Daubert v. Merrell Dow Pharmaceuticals.

He said Chhabria applied a more lenient standard than other circuits, finding district courts in the Ninth Circuit “must be more tolerant of borderline expert opinions than in other circuits.”

Judge Ryan Nelson, a Trump appointee, said although he was worried about a circuit split on Daubert, Chhabria probably didn’t abuse his discretion when he concluded that the jury should have the chance to weigh plaintiff’s expert testimony.  

“It’s a pretty tight minefield here for you,” he told Waxman.

“At a minimum, this court needs to state quite clearly that it hasn’t diverged from all the other circuits in the Daubert standard that is applied,” Waxman said. “The gatekeeping function is a real one and that courts cannot allow irrelevant or unreliable testimony to go to the jury on a theory that, well, cross examination can handle this.”

Waxman said an expert could not properly opine that Hardeman’s cancer was more likely than not caused by years of glyphosate exposure. He noted that 70% or more of non-Hodgkin’s lymphoma cases are idiopathic, meaning they have no known cause, though Weisenberger said he was able to rule out idiopathy because of the level of exposure Hardeman had while using Roundup for over 25 years.

Nelson pointed to the Ninth Circuit’s reversals in Wendell v. GlaxoSmithKline and Messick v Novartis, where the courts were found to have improperly excluded expert testimony on causation.

“It strikes me that we’ve got a lot of cases where district courts exclude and then get reversed. I’m sympathetic to the district court here who said ‘I’ve learned my lesson.’ We like district courts who learn the lesson. He seems to have done the right thing here,” Nelson said.

Judge Michael Daly Hawkins, a Clinton appointee, said the jury could have disregarded Weisenberger’s testimony.

“That is always the case,” Waxman said, but “his testimony was so unreliable that it should not have gone to the jury under the gatekeeping function.”

Nonetheless, Chhabria found the fact that a disease’s overwhelming idiopathy does defeat the ability to demonstrate specific causation.

Arguing for the plaintiff, David Wool with Andrus Wagstaff said Weisenberger was uniquely qualified to testify about causation. 

“In addition to being a pathologist, he is also an individual who had been studying the cause and effect of non-Hodgkin lymphoma vis-à-vis pesticides for more than 30 years,” he said.  

Wool also said Daubert does not require a scientific expert to establish proof beyond a reasonable doubt linking Hardeman’s cancer to Roundup. 

“Even if the district court had said there’s no biomarker, we want to exclude the experts, that’s a clear abuse of discretion right there,” he said.

Nelson asked if Wool believed the Ninth Circuit applies Daubert inconsistently with other circuits. 

“I think that the way Daubert is interpreted across circuits differs by case. You might say there is more strict interoperation in certain circumstances and a more liberal interpretation in others. But the point of that is that it simply underscores that Daubert is a context and fact-specific inquiry. That’s why district courts are afforded such latitude,” Wool said.

“I agree with your statement that it does give latitude, but I am a bit concerned about whether the Ninth Circuit has departed from other circuits and whether that needs to be corrected in some way,” Nelson said.

Wool said the plaintiff’s case would pass muster under any interpretation of the expert standard in Daubert. 

“We had statistically significant, fully adjusted epidemiology showing an odds ratio of over 2.0, which Monsanto concedes is sufficient infer specific causation,” he said.

Monsanto is also challenging Hardeman’s failure to warn claim brought under California’s Proposition 65, a regulation requiring manufacturers to put warning labels on products that contain chemicals at certain levels the state believes to be carcinogenic. 

California placed glyphosate on its Proposition 65 list based on the International Agency for Research on Cancer’s classification of the pesticide as “probably carcinogenic to humans.” 

The Environmental Protection Agency sent a letter to all glyphosate registrants in August 2019 saying products containing Proposition 65 warnings are misbranded under the Federal Insecticide, Fungicide, and Rodenticide Act because such a statement is “false and misleading.”

Though this letter was sent after the Hardeman verdict, Monsanto believes it carries enough weight to preempt any state-imposed cancer warning, and that Monsanto should not be held liable for violating state law by complying with the federal one.

The judges seemed far less interested in the EPA’s conclusions on glyphosate than in whether the agency’s August letter has the force of law. 

Nelson asked what deference, if any, the panel should give to it. Wool said regardless of the level of deference, the letter is just an “agency musing” that doesn’t have preemptive force.

He also said the EPA’s letter applies to glyphosate exclusively, whereas Hardeman’s claims were about the entire formulated Roundup product, which includes surfactants that can cause it to adhere and be absorbed into the skin.

“What the jury was asked to decide in this case whether Roundup caused Mr. Hardeman’s non-Hodgkin lymphoma. There was nothing about whether glyphosate itself would do so.”

Judge N. Randy Smith, a Bush appointee, asked Wool to distinguish Hardeman’s case from the Supreme Court’s ruling in Bates v. Dow Agrosciences , establishing a two-part test to determine whether state law claims on pesticide labeling are preempted by FIFRA, where a state must impose a “requirement for labeling and packaging” that must be “in addition to or different from” FIFRA’s requirement. 

Monsanto believed a higher toxicity warning on Roundup’s label would have violated EPA regulations and put it at odds with the uniformity requirement outlined in Bates.

Wool said Monsanto and the government did not point to a regulation that the EPA promulgated that could have a preemptive effect under Bates. He also noted that Monsanto never requested a label change from the EPA, even after Proposition 65 passed.

“The burden is always on the manufacturer to make sure its label is adequate,” he said. “It’s not sufficient to just turn things over the EPA.”

The hearing comes just as California’s Supreme Court rejected Monsanto’s bid to overturn a state appellate court’s ruling in favor of Dewayne Johnson. A jury awarded the Bay Area groundskeeper $289 million in punitive damages after trial in 2018, an amount later reduced by a trial judge to $78.5 million.

Bayer is now in the midst of contentious settlement negotiations with some 4,000 additional plaintiffs who are part of a federal multidistrict litigation in Chhabria’s court..

The panel took the arguments under submission.

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