Bayer Roundup trial goes virtual, and it does not go well

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In fits and starts, and with a good dose of frustration over technical difficulties, a California trial pitting an elderly cancer victim against Monsanto owner Bayer AG resumed on Monday in a virtual format after in-person proceedings were suspended last week, reportedly due to concerns about the spread of Covid-19.

Due to an array of technical problems, lawyers for plaintiff Donnetta Stephens were only able to present abbreviated testimony on Monday from expert witness Charles Benbrook, a former research professor who served at one time as executive director of the National Academy of Sciences board on agriculture.

Benbrook is considered a key witness, and is being called to testify about topics that include the history of scientific submissions to the U.S. Environmental Protection Agency (EPA) by Monsanto and alleged regulatory shortcomings.

The case, which is being tried in the Superior Court of San Bernardino County in California under the oversight of Judge Gilbert Ochoa,  is the fourth Roundup cancer trial to take place in the United States and the first since 2019. Juries in all three prior trials found in favor of the plaintiffs, agreeing with claims that Monsanto’s glyphosate-based weed killers, such as Roundup, cause non-Hodgkin lymphoma and Monsanto spent decades covering up the risks, and failing to warn users.

Stephens is one of tens of thousands of plaintiffs who filed lawsuits against Monsanto after the World Health Organization’s cancer experts classified glyphosate as a probable human carcinogen with an association to non-Hodgkin lymphoma.

The three prior trials were all lengthy, in-person proceedings loaded with weeks of highly technical testimony about scientific data, regulatory matters and documents detailing internal Monsanto communications.

Monday’s proceedings indicated that both sides may face significant challenges in trying to convey and combat the evidence and testimony in a virtual format.

Among the issues on Monday, a court reporter couldn’t fully hear the exchanges between lawyer and witness; jurors had difficulty turning on their computer cameras, a requirement issued by the judge; and the judge himself had to relocate at one point in an effort to improve audio transmission.

A courtroom attendant reassured the judge that he was checking in on the jurors every ten minutes and “it appeared that they were all paying attention.”

At one point when calling a break, Judge Ochoa pleaded: “Ladies and gentleman of the jury please, whatever you do, don’t turn off your computers, don’t touch them, just leave them alone and hopefully everybody’s computer will play nice.”

The judge recessed for the day in mid-afternoon, thanking the jurors for their patience.

“We did have some major technical difficulties,” Judge Ochoa said. He noted, however, that they “did make history” by holding the court’s first “Zoom trial.”

Covid delays one Roundup cancer trial while another looms

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The California trial pitting an elderly cancer victim against Monsanto owner Bayer AG has been delayed due to concerns about the spread of Covid-19, with proceedings now expected to resume next week in a virtual format via Zoom.

Lawyers for plaintiff Donnetta Stephens say that she was a regular user of Monsanto’s glyphosate-based Roundup herbicide for more than 30 years, an extended exposure that caused her to develop non-Hodgkin lymphoma (NHL).

Before the trial interruption jury members heard expert witness testimony from former U.S. government scientist Christopher Portier, who told jurors of multiple scientific studies that support claims glyphosate herbicides cause NHL. Lawyers for Monsanto sought to discredit Portier, and discount his testimony, arguing he had a vested financial interest in helping plaintiffs’ attorneys.

Additional experts were due to testify this week before in-person proceedings were scuttled due to positive cases of the Covid-19 virus showing up among people in the courtroom.

Stephens was diagnosed with NHL in 2017 and has suffered from numerous health complications amid multiple rounds of chemotherapy since then. Because of her poor health,  a judge in December granted Stephens a trial “preference,” meaning her case was expedited, after her lawyers informed the court that Stephens is “in a perpetual state of pain,” and losing cognition and memory.

She is one of tens of thousands of plaintiffs who filed lawsuits against Monsanto after the World Health Organization’s cancer experts classified glyphosate as a probable human carcinogen with an association to non-Hodgkin lymphoma.

She and the others who have sued allege that Monsanto has known for decades of scientific research showing its glyphosate herbicides could cause cancer, but has failed to warn users of the risks, working instead to suppress information about potential dangers.

The company lost the three trials held to date.

Trial with child plaintiff is next

Though Bayer last year said it was moving to settle outstanding Roundup lawsuits, many remain active and headed toward trial.

A boy with non-Hodgkin lymphoma is the subject of a trial scheduled for Sept. 13 in Los Angeles County Superior Court. Ezra Clark was “directly exposed” to Roundup many times as he accompanied his mother while she sprayed Roundup to kill weeds around the property where the family lived, according to court documents. Ezra sometimes played in freshly sprayed areas, according to the court filings.

Ezra was diagnosed in 2016, at the age of 4, with Burkitt’s lymphoma, a form of NHL that has a high tendency to spread to the central nervous system, and can also involve the liver, spleen and bone marrow, according to the court filings.

Ezra’s mother, Destiny Clark, is the plaintiff in the case, filing on behalf of Ezra.

Expedited trial sought for dying man

U.S. District Judge Vince Chhabria, who has been overseeing thousands of Roundup cases through multidistrict litigation proceedings set up in 2016 in federal court in the Northern District of California, has set several upcoming deadlines for moving cases forward that are under his purview. According to a court document filed Monday,  close to 4,000 cases have come under Chhabria’s oversight since the inception of the litigation.

Chhabria has ordered lawyers in the litigation to submit to him by Wednesday a list of certain cases that have not yet settled, and proposed schedules for advancing those cases. He also set a case management conference for Sept. 8.

At least one plaintiff is seeking an expedited trial, asking Chhabria to approve trial preference already granted him by a state court judge. Plaintiff Donald Miller was diagnosed with Stage IV non-Hodgkin lymphoma after using Roundup product for over four decades, according to the court filings.

Miller’s doctor estimated he had a five-year overall survival expectancy of only thirty-seven percent as of
February, 2020, according to court filings. A hearing on the matter is set for Sept. 23.

Many more cases remain pending in state courts, with plaintiffs’ lawyers jockeying for trial dates.

Bayer last week petitioned the U.S. Supreme Court to review one of its trial losses. The company claims federal law preempts key claims made in the litigation.

Bayer, which bought Monsanto in 2018, insists that when used as directed, its glyphosate herbicides are safe and do not cause cancer. It says regulatory approvals support its position.

Bayer seeks U.S. Supreme Court review of Roundup trial loss

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Monsanto owner Bayer AG on Monday filed a petition with the U.S. Supreme Court, seeking the high court’s review of one of its trial losses in the nationwide Roundup cancer litigation.

The move is widely seen as Bayer’s best hope for putting an end to claims that exposure to Monsanto’s glyphosate-based herbicides, such as the popular Roundup brand, cause non-Hodgkin lymphoma, and the company failed to warn users of the risks. The company has thus far lost three out of three trials, and there are currently more than 100,000 existing plaintiffs as well as many more potential future plaintiffs expected to bring similar claims. Bayer has been trying to settle the cases and come up with a plan to limit, block or settle future claims.

Bayer’s writ of certiorari asks the court to review the Ninth Circuit Court of Appeals’ decision in the case of Hardeman v. Monsanto. 

During the month-long trial in 2019, lawyers for plaintiff Edwin Hardeman presented jurors with a range of scientific research showing cancer connections to Monsanto’s herbicides as well as evidence of many Monsanto strategies aimed at suppressing the scientific information about the risks of its products. Internal Monsanto documents showed the company’s scientists had engaged in secretly ghost-writing scientific papers that the company then used to help convince regulators of product safety.

The plaintiffs’ attorneys argued that Monsanto should have warned consumers about the risks that its products could cause cancer. Lawyers in the other trials Monsanto lost presented similar arguments and evidence of cancer risk.

FIFRA fight

Bayer has said it hopes the Supreme Court will agree with Bayer’s position that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which governs the registration, distribution, sale, and use of pesticides in the United States, preempts those “failure-to-warn” claims that are central to the Roundup lawsuits. Because the Environmental Protection Agency (EPA) has approved labels with no cancer warning, the failure-to-warn claims should be barred, the company maintains.

The petition filed Monday urges the Supreme Court to review the Ninth Circuit Court of Appeals’ decision upholding the Hardeman trial loss on the grounds that FIFRA preempts a state-law failure to-warn claim “where the warning cannot be added to a product without EPA approval and EPA has repeatedly concluded that the warning is not appropriate.”

The petition also asks the court to address whether or not the Ninth Circuit’s standard for admitting expert testimony “is inconsistent with this Court’s precedent and Federal Rule of Evidence 702.” Bayer argues that the admission of expert testimony in the Hardeman case “departed from federal standards, enabling plaintiff’s causation witnesses to provide unsupported testimony on the principal issue in the case, Roundup’s safety profile.”

In its petition, Bayer argues: “The Ninth Circuit’s errors mean that a company can be severely punished for marketing a product without a cancer warning when the near-universal scientific and regulatory consensus is that the product does not cause cancer, and the responsible federal agency has forbidden such a warning.”

Hardeman lawyer Aimee Wagstaff said her legal team had been preparing for Bayer’s bid for Supreme Court review.

“While paying out billions of dollars to settle claims, Monsanto continues to refuse to pay Mr. Hardeman’s verdict.  That doesn’t seem fair to Mr. Hardeman.  Even so, this is Monsanto’s last chance Hail Mary,” Wagstaff said. “We are eager and ready to beat Monsanto at the Supreme Court and put this baseless preemption defense behind us once and for all.”

Bayer cites broad impact

The petition states that the decision in the Hardeman case, which was part of the multidistrict litigation handled in federal court, will “undoubtedly influence still others pending across the country.”

Bayer said in a statement: “The Petition underscores that consistent regulatory assessments in the U.S. and worldwide, and the overwhelming weight of scientific evidence, support the conclusion that glyphosate-based herbicides are safe and not carcinogenic. In light of the EPA’s approval of the Roundup label without a cancer warning, any state-law failure-to-warn claims premised on such warning would plainly conflict with federal law and thus are preempted. Courts across the U.S. have divided on this basic question of when federal law preempts state law, which makes review by the U.S. Supreme Court both important and necessary. Indeed, it has been 16 years since the Supreme Court ruled on FIFRA preemption, and the prior case did not involve a warning that EPA had rejected.”

Lawyers for Hardeman did not respond to a request for comment.

Bayer has so far said it has earmarked more than $16 billion toward settling the Roundup litigation.

Scientist testifies in Roundup trial; judge reverses ruling that had helped Monsanto

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A former U.S. government scientist testifying in the fourth Roundup cancer trial to be held in the United States told a California jury this week that multiple research studies conducted over many years show an “almost certain” connection between Monsanto glyphosate-based herbicides and cancer.

Christopher Portier, who is testifying as expert witness on behalf of plaintiff Donnetta Stephens in her lawsuit against Monsanto, appeared in person in the courtroom earlier in the week but answered questions from Monsanto’s lawyer via Zoom on Thursday due to travel commitments.

Portier was also an expert witness for the plaintiffs in the three prior Roundup trials. In each of the prior trials, juries agreed that Monsanto’s glyphosate herbicides caused the plaintiffs to develop a type of cancer called non-Hodgkin lymphoma (NHL).

In hours of testimony that stretched over several days, Portier told jury members about studies done on human cell lines as well as studies conducted on laboratory animals and studies of exposure and disease incidence in humans. The evidence of a cancer connection was strongest in the animal studies, and was supported by the additional research, he said.

“I am certain that glyphosate can cause tumors in animals,” including malignant lymphomas in mice, Portier testified. When asked his opinion on the question of whether or not real-world Roundup exposure can cause NHL in people, Portier said: “I believe that it does, I think the strength of that belief is almost certain but not quite.”

Regular Roundup user 

Lawyers for Stephens say that she was a regular user of Roundup herbicide for more than 30 years and it was that extended exposure to the glyphosate-based products made popular by Monsanto that caused her NHL.

Stephens was diagnosed in 2017 and has suffered from numerous health complications amid multiple rounds of chemotherapy since then. Because of her poor health,  a judge in December granted Stephens a trial “preference,” meaning her case was expedited, after her lawyers informed the court that Stephens is “in a perpetual state of pain,” and losing cognition and memory.

She is one of tens of thousands of plaintiffs who filed U.S. lawsuits against Monsanto after the World Health Organization’s cancer experts classified glyphosate – the active ingredient in Monsanto’s herbicides – as a probable human carcinogen with an association to non-Hodgkin lymphoma.

Judge Gilbert Ochoa of the Superior Court of San Bernardino County in California is overseeing the proceedings.

Judge reverses order on preemption

In a move that could prove important to the outcome of the case,  Judge Ochoa this week reversed his own pretrial ruling related to Monsanto’s argument that federal law preempts the “failure to warn” claims that Stephens’ lawyers want to present to the jury.

The judge had agreed with Monsanto that federal law regarding pesticide regulation and labeling preempts failure-to-warn claims under state law, and he had limited the ability of Stephens’ lawyers to pursue such claims.

But the judge changed his position after the 1st Appellate District in the Court of Appeal for California issued a ruling on Monday denying Monsanto’s preemption argument in a separate case.

The appeals court issued scathing criticism of Monsanto, writing that “substantial evidence supports the jury’s verdicts” and that “Monsanto’s conduct evidenced reckless disregard of the health and safety of the multitude of unsuspecting consumers it kept in the dark.”

The day after the appeals court ruling, Monsanto noted in a brief filed with Judge Ochoa that it recognized the appellate court decision was “binding” on the San Bernardino court, but said the appeals court “committed legal error.”

Monsanto owner Bayer AG has said publicly it sees its best hope of escaping ongoing litigation in persuading the U.S. Supreme  Court to review and overturn one of the trial losses on the preemption issue.

Another trial sought in St. Louis 

After losing the first three trials, Bayer, which bought Monsanto in 2018, has settled other cases that had been scheduled to go to trial. And in 2020, the company said it would pay roughly $11 billion to settle about 100,000 existing Roundup cancer claims. Late last month, Bayer said it would set aside another $4.5 billion toward Roundup litigation liability.

Bayer also announced it would stop selling Roundup, and other herbicides made with the active ingredient glyphosate, to U.S. consumers by 2023. But the company continues to sell the products for use by farmers and commercial applicators.

But several law firms continue to seek to bring cases to trial. In late July, lawyers for a group of 13 plaintiffs filed a motion with the St. Louis County Circuit Court seeking a trial date. That case is 19SL-CC04115, Kyle Chaplick et al v Monsanto.

Appeals court rejects Bayer bid to overturn Roundup trial loss; cites Monsanto “reckless disregard” for consumer safety

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Monsanto owner Bayer AG has lost another appeals court decision in the sweeping U.S. Roundup  litigation, continuing to struggle to find a way out from under the crush of tens of thousands of claims alleging that Monsanto’s glyphosate-based herbicides cause cancer.

In a decision handed down on Monday, the 1st Appellate District in the Court of Appeal for California rejected Monsanto’s bid to overturn the trial loss in a case brought by husband-and-wife plaintiffs, Alva and Alberta Pilliod.

“We find that substantial evidence supports the jury’s verdicts,” the court stated. “Monsanto’s conduct evidenced reckless disregard of the health and safety of the multitude of unsuspecting consumers it kept in the dark. This was not an isolated incident; Monsanto’s conduct involved repeated actions over a period of many years motivated by the desire for sales and profit.”

The court specifically rejected the argument that federal law preempts such claims, an argument Bayer has told investors offers a potential path out of the litigation. Bayer has said it hopes it can get the U.S. Supreme  Court to agree with its preemption argument.

In May 2019 a jury awarded the Pilliods more than $2 billion in punitive and compensatory damages after lawyers for the couple argued they both developed non-Hodgkin lymphoma caused by their many years of using Roundup products.

The trial judge lowered the combined award to $87 million.

In appealing the loss, Monsanto argued not only that the Pilliod claims were preempted by federal law, but also that the jury’s causation findings were flawed, the trial court should not have admitted certain evidence, and that “the verdict is the product of attorney misconduct.” Monsanto also wanted the damage awards further slashed.

Court slams company

In the appeals court decision, the court left the award unchanged, and said that Monsanto had not shown that federal law did preempt such claims as those made by the Pilliods. The court also said there was substantial evidence that Monsanto acted with a “willful and conscious disregard for the safety of others,” supporting the awarding of punitive damages.

The evidence showed that Monsanto “failed to conduct adequate studies on glyphosate and Roundup, thus impeding discouraging, or distorting scientific inquiry concerning glyphosate and Roundup,” the court said.

The court also chastised Monsanto for not accurately presenting “all of the record evidence” in making its appeal: “But rather than fairly stating all the relevant evidence, Monsanto has made a lopsided presentation that relies primarily on the evidence in its favor. This type of presentation may work for a jury, but it will not work for the Court of Appeal.”

The court added: “The trial described in Monsanto’s opening brief bears little resemblance to the trial reflected in the record.”

“Summed up, the evidence shows Monsanto’s intransigent unwillingness to inform the public about the carcinogenic dangers of a product it made abundantly available at hardware stores and garden shops across the country,” the court said.

Another trial underway now

The Pilliod trial was the third against Monsanto. In the first trial, a unanimous jury awarded plaintiff Dewayne Johnson $289 million;  the plaintiff in the second trial was awarded $80 million.

The fourth trial began last week. A jury of seven men and five women on Monday were hearing testimony in the case of Donnetta Stephens v. Monsanto in the Superior Court of San Bernardino County in California.  Retired U.S. government scientist Christopher Portier, who has been an expert witness for the plaintiffs in prior Roundup trials, testified at length on Monday, reiterating previous testimony that there is clear scientific evidence showing glyphosate and glyphosate-based formulations such as Roundup can cause cancer.

Bayer, which bought Monsanto in 2018, has settled several other cases that were scheduled to go to trial over the last two years. And in 2020, the company said it would pay roughly $11 billion to settle about 100,000 existing Roundup cancer claims. Late last month, Bayer said it would set aside another $4.5 billion toward Roundup litigation liability.

Bayer also announced it would stop selling Roundup, and other herbicides made with the active ingredient glyphosate, to U.S. consumers by 2023. But the company continues to sell the products for use by farmers and commercial applicators.

Bayer heads into next U.S. cancer trial, opening statements set for Thursday

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Despite Bayer AG’s efforts to put an end to costly litigation inherited in its acquisition of Monsanto, opening statements in yet another trial are set for Thursday as a woman suffering from non-Hodgkin lymphoma claims Monsanto’s Roundup herbicide caused her cancer.

A jury of seven men and five women have been seated in the case of Donnetta Stephens v. Monsanto in the Superior Court of San Bernardino County in California.  Judge Gilbert Ochoa was hearing last-minute arguments over evidence on Wednesday.

The trial comes a week after Bayer announced it would stop selling Roundup, and other herbicides made with the active ingredient glyphosate, to U.S. consumers by 2023. Monsanto was purchased by Bayer AG in 2018, and Bayer insists, just as Monsanto has for decades, that there is no valid evidence of a cancer connection between its weed killing products and cancer.

Bayer said the move to stop selling the  herbicides to consumers was “to manage litigation risk and not because of any safety concerns.” The company said it will continue to sell its glyphosate-based herbicides for commercial use and for use by farmers.

Bayer also said last week it was setting aside $4.5 billion – on top of roughly $11 billion already earmarked for Roundup litigation settlements – to cover “potential long-term exposure” to liability associated with claims from cancer victims such as Stephens.

Bayer further said with respect to ongoing litigation, it “will be very selective in its settlement approach in the coming months.”

Evidence at issue

Ahead of the opening statements in the Stephens trial, many issues were being argued without the jury present on Wednesday in front of Judge Ochoa, including the scope of allowable arguments by plaintiffs that Monsanto should have provided warnings to Roundup users that certain scientific research showed links between its products and cancer.

Judge Ochoa earlier ruled – in agreement with Monsanto – that federal law regarding Environmental Protection Agency (EPA) oversight of pesticide product labeling preempts “failure to warn” claims under state law, meaning Stephens’ lawyers would not be able to pursue such claims.

The plaintiffs still hope to argue, however, that separate from the labeling issues, Monsanto could have, and should have, warned consumers about the potential cancer risk in other ways, according to Stephens’ lawyer Fletcher Trammell. He and Stephens’ other lawyers will seek to prove that Monsanto made an unsafe herbicide product and knowingly pushed it into the marketplace despite scientific research showing glyphosate-based herbicides could cause cancer.

Lawyers for Stephens say that she was a regular user of Roundup herbicide for more than 30 years and it was that extended exposure to the glyphosate-based products made popular by Monsanto that caused her non-Hodgkin lymphoma.

Stephens was diagnosed in 2017 and has suffered from numerous health complications amid multiple rounds of chemotherapy since then.  She is one of tens of thousands of plaintiffs who filed U.S. lawsuits against Monsanto after the World Health Organization’s cancer experts classified glyphosate – the active ingredient in Monsanto’s herbicides – as a probable human carcinogen with an association to non-Hodgkin lymphoma.

The list of evidence to be presented at trial runs more than 250 pages and includes scientific studies as well as Monsanto emails and other internal corporate documents. A federal judge who has been overseeing nationwide Roundup litigation stated in a recent order that there is “a good deal of damning evidence against Monsanto—evidence which suggested that Monsanto never seemed to care whether its product harms people.”

Close to 70 people are listed as witnesses to testify at trial, either live or through deposition testimony, including many former Monsanto scientists and executives.

The first witness set to take the stand is retired U.S. government scientist Christopher Portier, who has been an expert witness for the plaintiffs in each of the prior Roundup trials. Portier has previously testified that there is clear scientific evidence showing glyphosate and glyphosate-based formulations such as Roundup can cause cancer in people. He has also testified in the past that U.S. and European regulators have not properly assessed the science and have ignored research showing cancer concerns with Monsanto’s herbicides.

Before retiring, Portier led the National Center for Environmental Health/Agency for Toxic Substances and Disease Registry at the Centers for Disease Control and Prevention (CDC), part of the U.S. Department of Health and Human Services. Prior to that role, Portier spent 32 years with the National Institute of Environmental Health Sciences, where he served as associate director, and director of the Environmental Toxicology Program, which has since merged into the institute’s National Toxicology Program. Portier was also an “invited specialist” to the International Agency for Research on Cancer unit of the World Health Organization when the group made its probable carcinogen classification of glyphosate in 2015.

Bayer hopes for help from Supreme Court

Monsanto has lost three out of three previous trials, with a jury in the last trial – held in 2019 – ordering a staggering $2 billion in damages due to what the jury saw as egregious conduct by Monsanto in failing to warn users of evidence – including numerous scientific studies – showing a connection between its products and cancer. (The award was later shaved to $87 million.)

In trying to free itself from the weight of Monsanto-related woes, Bayer said last week that in addition to  replacing its glyphosate-based products in the U.S. residential market with new formulations using alternative ingredients, it is exploring changes to Roundup labeling.

“It is important for the company, our owners, and our customers that we move on and put the uncertainty and ambiguity related to the glyphosate litigation behind us,” Bayer CEO Werner Baumann said during a recent investor call.

The company also said it will file a petition this month seeking U.S. Supreme Court review of one of its trial losses – the case of Hardeman v. Monsanto. Bayer said if the Supreme Court grants review,  the company “will not entertain any further settlement discussions” while the court reviews the appeal.

In the event of a “negative Supreme Court outcome,” Bayer said it would set up a claims’ administration program that will offer “pre-determined compensation values”  to “eligible individuals” who used Roundup and developed non-Hodgkin lymphoma over the next 15 years.

New Roundup cancer trial starting in California

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Lawyers representing a woman suffering from cancer are prepared to face off against Monsanto and its German owner Bayer AG in a California courtroom on Monday in what is set as the fourth trial over allegations Monsanto’s popular Roundup weed killers cause non-Hodgkin lymphoma (NHL).

Jury selection in the case of Donnetta Stephens v. Monsanto is expected to take several days and the trial itself is expected to last up to eight weeks. Judge Gilbert Ochoa of the Superior Court of San Bernardino County in California is overseeing the proceedings.

Monsanto has lost three out of three previous trials, with a jury in the last trial – held in 2019 – ordering a staggering $2 billion in damages due to what the jury saw as egregious conduct by Monsanto in failing to warn users of evidence – including numerous scientific studies – showing a connection between its products and cancer. (The award was later shaved to $87 million.)

Lawyers for Stephens say that she was a regular user of Roundup herbicide for more than 30 years and it was that extended exposure to the glyphosate-based products made popular by Monsanto that caused her NHL.

Stephens was diagnosed in 2017 and has suffered from numerous health complications amid multiple rounds of chemotherapy since then. Because of her poor health,  a judge in December granted Stephens a trial “preference,” meaning her case was expedited, after her lawyers informed the court that Stephens is “in a perpetual state of pain,” and losing cognition and memory.

She is one of tens of thousands of plaintiffs who filed U.S. lawsuits against Monsanto after the World Health Organization’s cancer experts classified glyphosate – the active ingredient in Monsanto’s herbicides – as a probable human carcinogen with an association to non-Hodgkin lymphoma.

Judge Ochoa has made several pretrial rulings, including agreeing with Monsanto that federal law regarding pesticide regulation and labeling preempts “failure to warn” claims under state law and  Stephens’ lawyers would not be able to pursue such claims.

The plaintiffs still will be able to argue that separate from the labeling issues, Monsanto could have, and should have, warned consumers about the potential cancer risk in other ways, according to Stephens’ lawyer Fletcher Trammell. He and Stephens’ other lawyers will seek to prove their claims that Monsanto made an unsafe herbicide product and knowingly pushed it into the marketplace despite scientific research showing glyphosate-based herbicides could cause cancer.

Monsanto was purchased by Bayer AG in 2018 and is no longer a stand-alone company but is the named defendant in ongoing litigation. Bayer insists, just as Monsanto has for decades, that there is no valid evidence of a cancer connection between its weed killing products and cancer.

Questions for the Jury

Jury selection is deemed a critical part of any trial and as the opposing sides look at the pool of  prospective jurors for the Stephens trial they will be screening them for signs of bias. According to a jury questionnaire, among the questions jurors are to be asked are these:

  • Do you believe most companies’ scientific studies regarding safety are altered to further a specific agenda?
  • Do you have any opinions about how well most corporations communicate safety information about their products to the public?
  • Do you, or does anyone close to you, have any health problems or concerns resulting from any products you or they have used or been around?
  • Do you believe that any exposures to hazardous chemicals, no matter how small, is harmful to humans?

The jurors who are selected will face a daunting amount of evidence, including scientific studies and internal Monsanto records. The list of evidence, in the form of ‘exhibits’ to be presented at trial, runs more than 250 pages and includes many damning Monsanto emails and other documents that led a federal judge who has been overseeing nationwide Roundup litigation to state in a recent order that the trials have provided “a good deal of damning evidence against Monsanto—evidence which suggested that Monsanto never seemed to care whether its product harms people.”

There also will be many witnesses involved in the trial. Stephens’ lawyers have listed 39 people they intend to call to testify,  including deposition testimony of Monsanto scientist Donna Farmer,  former Monsanto Chairman Hugh Grant, and multiple other Monsanto executives.

Monsanto’s witness list includes many of the company’s executives and scientists as well as former Environmental Protection Agency (EPA) official Jess Rowland, who has been revealed as an ally and friend to the company in the ongoing litigation. Monsanto has listed a total of 32 individuals as witnesses for the defense.

Bayer Looking for a Win

In the first trial against Monsanto, a unanimous jury awarded plaintiff Dewayne Johnson $289 million; the plaintiff in the second trial was awarded $80 million; and the jury in the third trial awarded more than $2 billion to husband-and-wife plaintiffs. All the awards were reduced sharply by judges involved in the cases but the verdicts assigning blame to Monsanto for the cancers have not been overturned.

Bayer sees the preemption argument as critical to its ability to limit the ongoing litigation liability. The company has made it clear that it hopes at some point to get a U.S. Supreme Court finding that under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the EPA’s position that Monsanto’s herbicides are not likely to cause cancer essentially bars complaints that Monsanto didn’t warn of any cancer risk.

Even as it pursues a preemption ruling, Bayer said last year that it had agreed to pay close to $11 billion to settle existing Roundup cancer claims. But many law firms have dismissed the individual offers for their clients as insufficient, and they continue to press for more trials.

Bayer said recently it is considering pulling Roundup products from the U.S. market for residential users, though not from farm use.

Bayer gets lift in pre-trial ruling ahead of Roundup cancer trial

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A California judge gave Monsanto and its German owner Bayer AG a pre-trial boost in a ruling issued Monday, a week before the scheduled start of a new courtroom challenge to the safety of Monsanto’s Roundup herbicides.

Judge Gilbert Ochoa of the Superior Court of San Bernardino County in California agreed with Monsanto that federal law regarding pesticide regulation and labeling preempts “failure to warn” claims under state law, and the plaintiff in the trial set to start next week will not be allowed to pursue such claims.

“The Court grants Defendant Monsanto Motion for Summary Adjudication of the 2nd and 4th causes of action on the grounds the failure to warn or concealment of glyphosate’s link to cancer is expressly and/or impliedly preempted” by federal law, Ochoa wrote in his order.

The decision was “surprising” to plaintiff’s attorney Fletcher Trammell, who is representing plaintiff Donnetta Stephens in the case against Monsanto. “Obviously we disagree,” he said. The issue could be subject of appeal at some point, he added.

The claims that Monsanto made an unsafe product and knowingly pushed it into the marketplace remain intact and will be presented at trial, according to Trammell.

More Than Two Years

It’s been more than two years since Bayer has had to defend the safety of Monsanto’s weed killing products at a trial. Monsanto has lost three out of three previous trials, with a jury in the last trial ordering a staggering $2 billion in damages due to what the jury saw as egregious conduct by Monsanto in failing to warn users of evidence – including numerous scientific studies – showing a connection between its products and cancer.

Lawyers for Stephens, a regular user of Roundup herbicide for more than 30 years, will try to prove that exposure to the glyphosate-based products made popular by Monsanto caused Stephens to develop non-Hodgkin lymphoma (NHL).

The case is set for trial Monday July 26, delayed by one week as the court deals with a variety of pre-trial motions.  Stephens was diagnosed with NHL in 2017 and has suffered from numerous health complications amid multiple rounds of chemotherapy since then. Because of her poor health,  a judge in December granted Stephens a trial “preference,” meaning her case was expedited, after her lawyers informed the court that Stephens is “in a perpetual state of pain,” and losing cognition and memory.

Several other cases have either already been granted preference trial dates or are seeking trial dates for other plaintiffs, including at least two children, suffering from NHL the plaintiffs allege was caused by exposure to Roundup products.

Monsanto was purchased by Bayer AG in 2018 and is no longer a stand-alone company but is the named defendant in ongoing litigation, which began in 2015 after cancer experts consulted by a unit of the World Health Organization determined glyphosate is a probable human carcinogen with a particular association to NHL.

Roughly 100,000 people in the United States have claimed they developed NHL because of their exposure to Roundup or other Monsanto-made glyphosate-based herbicides.

Preemption Argument

Bayer sees the preemption argument as critical to its ability to limit the ongoing litigation liability. The company has made it clear that it hopes at some point to get a U.S. Supreme Court finding that under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the U.S. Environmental Protection Agency’s (EPA) position that Monsanto’s herbicides are not likely to cause cancer essentially bars complaints that Monsanto didn’t warn of any cancer risk.

Critics of that position point to a 2005 U.S. Supreme Court ruling in a case titled Bates v. Dow Agrosciences, which established that the EPA’s approval of a product does not rule out claims of a failure to warn brought under state law. Citing the law and the Bates precedent, more than a dozen federal and state courts have rejected the preemption argument.

But some legal experts argue the rejections of the preemption argument in the Roundup litigation are flawed and believe Bayer has a solid defense on that issue.

If Bayer can ultimately get a U.S. Supreme Court win on the preemption question, it could thwart the key claims brought by tens of thousands of plaintiffs and potentially save Bayer from significant ongoing legal liability costs.

In the first trial against Monsanto, a unanimous jury awarded plaintiff Dewayne Johnson $289 million; the plaintiff in the second trial was awarded $80 million; and the jury in the third trial awarded more than $2 billion to husband-and-wife plaintiffs. All the awards were reduced sharply by judges involved in the cases but the verdicts assigning blame to Monsanto for the cancers have not been overturned.

Bayer settlement

Bayer said last year that it had agreed to pay close to $11 billion to settle existing Roundup cancer claims, but many law firms have dismissed the individual offers for their clients as insufficient, and they continue to press for more trials.

Additionally, Bayer has thus far failed to get court approval for varying proposals to try to create a class action settlement program for people who bring cancer claims in the future. After a stinging rebuke of its plans by a federal judge overseeing much of the litigation, Bayer said it is considering pulling Roundup products from the U.S. market for residential users, though not from farm use.

The case is Stephens v. Monsanto CIVSB2104801 in the Superior Court of California – County of San Bernardino.

New analysis of glyphosate industry studies finds them outdated, flawed

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See Carey Gillam’s article in The Guardian, Corporate studies asserting herbicide safety show many flaws, new analysis finds (July 2, 2021). In this post we provide links to the 53 once-secret studies and related materials. 

Questions about the safety of glyphosate-based herbicides (GBHs) have persisted for years, as scientific research has split over whether or not the widely used weed killing chemical introduced by Monsanto in the 1970s causes cancer or other human health problems.

A number of independent studies show links between glyphosate herbicides and cancer and other health problems, leading the International Agency for Research on Cancer in 2015 to classify glyphosate as a probable human carcinogen.

But Monsanto, purchased by Bayer AG in 2018, has maintained glyphosate is not carcinogenic, nor does it cause other health problems when used as directed. Other large chemical companies that sell glyphosate or related products echo Monsanto’s safety assurances.

Regulators in Europe and the United States, Canada and elsewhere have affirmed the corporate assertions of glyphosate safety. They point to decades of tests conducted by or for the companies that have not been published but which regulators have reviewed, as well as published studies in the scientific literature.

The corporate studies have long been kept secret, even by regulators. But in Europe, litigation by a group of European Parliament lawmakers led to the release of dozens of such studies.

A consumer advocacy group, SumOfUs, provided more than 50 studies to two independent scientists for review – Armen Nersesyan and Siegfried Knasmueller, both from the Institute of Cancer Research, Department of Medicine at the Medical University of Vienna.

Knasmueller, the lead author, is an expert in genetic toxicology and along with his work at the cancer institute is editor-in-chief of two prominent scientific journals, including Mutation Research – Genetic Toxicology and Environmental Mutagenesis.

The goal of the evaluation was to determine if the industry studies examined comply with current international guidelines for chemical testing. The studies are those concerning the genotoxic properties of glyphosate.

The resulting analysis was released July 2, 2021 and concluded that the bulk of the industry studies were outdated and did not meet current guidelines. An array of shortcomings and flaws were found in the studies, rendering most of them unreliable, according to the analysis.

In fact, of the 53 studies submitted to regulators by the companies, only two were acceptable under current internationally recognized scientific standards, said Knasmueller.

Knasmueller said there are more reliable methods for detecting carcinogens but those were not used in the industry tests. Read the evaluation here. 

Regulatory renewal sought

The analysis of the older studies comes as the companies that sell glyphosate products are seeking reauthorization in Europe and trying to fight against calls for restrictions and bans on glyphosate across the globe.

In June 2021, the European Union’s (EU) Assessment Group on Glyphosate (AGG) issued an 11,000-page draft report concluding that glyphosate is safe when used as directed and does not cause cancer. The finding is based in part on a dossier of roughly 1,500 studies submitted to European regulators by the “Glyphosate Renewal Group (GRG),” a collection of companies that includes Bayer.

Bayer confirmed that the older studies were included in the new dossier given to European regulators, but said the GRG was “required to submit all genotoxicity studies that have been conducted, including those submitted in past registration review cycles.” The company said the dossier also includes “new genotoxicity studies conducted since the previous re-approval of glyphosate and a vast review of thousands of published scientific publications regarding glyphosate.”

The companies are seeking the renewal of the EU authorization of glyphosate. Current authorization in Europe expires in December 2022. The companies say they also gave regulators a “literature review” of around 12,000 published scientific articles on glyphosate.

 The European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) are organizing public consultations to start in September.

The Knasmueller analysis drew both criticism and support from a mix of scientists who reviewed the work. Here are two comments:

Paul Demers,  director of the Occupational Cancer Research Centre, Ontario Health, in Canada:

The classification of the carcinogenicity of glyphosate has been particularly contentious with international bodies disagreeing not only on areas of interpretation but even on which studies to consider. The critical evaluation, using the latest OECD criteria, of 53 studies submitted to Bundesinstitut für Risikobewertung and European Food Safety Authority is a valuable contribution to the ongoing debate on the carcinogenicity of glyphosate. The observation by the authors that few of these studies met the OECD criteria should be considered by regulatory authorities tasked with protecting workers and the public. Personally, I agree with the approaches for evaluation taken by the International Agency for Research on Cancer, which were used for glyphosate. That said, I also believe that there needs to room for scientific debate and disagreements on issues of interpretation, criteria for evaluation, and even what studies to include. However, there should not be a debate on transparency when it comes to the evidence considered by public bodies in determining the safety of chemicals.  Studies of health effects, with sufficient details regarding the methods used and the results, need to be accessible and open to the critical eyes of the scientific community and other concerned parties.” 

Raymond Tice, retired scientist, U.S. National Institute of Environmental Health Sciences, former  President of the U.S. Environmental Mutagen Society: “An analysis of the experimental data supporting the safety of any chemical should be conducted using systematic review methodology… which takes into account not only the completeness of the information but also categorizes the risk of bias, whether positive or negative.  Clearly, this was not conducted by EFSA or by Dr. Knasmueller.  In general, it is not appropriate to disregard all studies that do not meet current standards, but rather to consider the results in terms of their limitations. Overall, It seems to me that Knasmueller is selective (i.e., exhibits bias) in what he presents and does not present. At the same time, I would fault EFSA for not doing due diligence in what they considered…  Also, I agree that there is a suggestion that (glyphosate) is linked to the induction of oxidative stress which can result in DNA damage (i.e., oxidative stress is one of the key characteristics of carcinogens) but would be expected to have a threshold below which damage is not likely to result in an adverse effect.”

Once-secret studies

See the full analysis, authors’ comments, industry summaries, a list of studies submitted for the current European Union re-authorization, and links to 53 previously secret corporate glyphosate studies below:

Reference-List-of-Glyphosate-Studies-submitted-for-the-Renewal-of-Approval-AIR5-of-Glyphosate-in-2020-EN

European Assessment Group on Glyphosate report on glyphosate renewal

Evaluation of the scientific quality of industry studies of genotoxic properties of glyphosate

Comments concerning the mutagenic/genotoxic properties of glyphosate

Toxicological and Metabolism Studies summary by industry

Albaugh 2014 glyphosate reverse mutation assay Switzerland

Syngenta 2012 glyphosate technical micronucleus assay in bone marrow cells of the mouse

Dow Chemical 2012 Micronucleus test of glyphosate TGAI in mice

Industrias Afrasa 2012 reverse mutation with glyphosate

Helm 2010 Reverse Mutation Assay glyphosate using bacteria

Helm 2010 reverse mutation assay 

Helm 2010 mutagenicity of glyphosate testing

Helm 2009 mutagenicity study of glyphosate Germany

Helm 2009 Micronucleus test of glyphosate in bone marrow cells of rat

Syngenta 2009 glyphosate reverse mutation

Jingma Chemicals China 2008 evaluation of the mutagenic potential of glyphosate by reverse mutation assay 

Jingma 2008 evaluation of mutagenic potential of glyphosate by micronucleus assay in mice

Syngenta 2008 glyphosate micronucleus assay in bone marrow cells of the mouse

Helm 2007 Mammalian erythrocyte micronucleus test for glyphosate

Helm Do Brasil 2007 Bacterial reverse mutation test glyphosate

Nufarm 2007 reverse mutation glyphosate technical 05068

Nufarm 2007 1061403 reverse mutation glyphosate technical 05067

Nufarm 2007 1061402 reverse mutation glyphosate technical 05070 

Nufarm 2005 glyphosate technical micronucleus test in the mouse

Monsanto 1998 Mouse micronucleus screening assay of MON-0818

Zeneca Glyphosate 1998 acid Invitro 

Cheminova 1996 reverse mutation glyphosate Brazil

Cheminova 1996 A micronucleus study in mice for the product GILFOS

Zeneca 1996 glyphosate mutagenicity potential

Zeneca 1996 Glyphosate acid mouse bone marrow micronucleus test

Zeneca 1996 glyphosate acid mouse lymphoma gene mutation assay

Sanko 1995 glyphosate in vitro cytogenetics

Sanko 1995 glyphosate DNA Repair Test

Sankyo 1995 reverse mutation study 

Mastra and Maruzen Kako 1995 Technical glyphosate

Mastra and Maruzen Kako 1995 reverse mutation assay glyphosate

Agrichem 1995 Evaluation of ability of glyphosate to induce chromosome aberrations

Feinchemie Schwebda 1994 DNA repair test with primary rat hepatocytes

Feinchemie Schwebda 1994 in vivo mammalian bone marrow cytogenetic test

Feinchemie Schwebda 1993 Mutagenicity-micronucleus glyphosate test in swiss albino mice

Feinchemie Schwebda 1992 Dominant lethal test in Wistar rats

Monsanto 1992 Mouse micronucleus study of Roundup

Monsanto 1992 glyphosate mutagenicity assay on Roundup

Monsanto 1992 Mouse micronucleus study of RODEO glyphosate formulation

Monsanto 1992 glyphosate mutagenicity assay on RODEO herbicide

Monsanto 1992 mouse micronucleus study of DIRECT formulation

Monsanto 1992 glyphosate mutagenicity potential DIRECT brand

Hoechst Dodigen 4022 1992 study of mutagenic potential in strains of salmonella and E Coli

Hoechst Dodigen 4022 1992 Chromosome aberrations in vitro in V79 Chinese hamster cells

Cheminova 1991 #12323 glyphosate mutagenicity test

Cheminova 1991 #12324 Mutagenicity test micronucleus glyphosate

Cheminova 1991 #12325 glyphosate mutagenicity test in vitro mammalian cell gene mutation test

Monsanto 1990 Ames Salmonella mutagenicity assay of MON 0818

Monsanto 1983 In vivo bone marrow cytogenetics study of glyphosate in Sprague-Dawley rats

Monsanto 1983 glyphosate gene mutation assay

Monsanto 1981 Ames salmonella mutagenicity assay of MON 8080

Monsanto 1980 Dominant lethal mutagenicity assay with technical glyphosate in mice

Institute of Environmental Toxicology 1978 Glyphosate report of mutagenic study with bacteria

The Dicamba Papers: Key Documents and Analysis

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Dozens of farmers around the United States are suing the former Monsanto Co., purchased in 2018 by Bayer AG, and conglomerate BASF in an effort to hold the companies accountable for millions of acres of crop damage the farmers claim is due to widespread illegal use of the weed killing chemical dicamba, use  promoted by the companies.

The first case to go to trial pitted Missouri’s Bader Farms against the companies and resulted in a $265 million verdict against the companies. The jury awarded $15 million in compensatory damages and $250 million in punitive damages.

The case was filed in the U.S. District Court for the Eastern District of Missouri, Southeastern Division, Civil Docket #1:16-cv-00299-SNLJ. The owners of Bader Farms alleged the companies conspired to create an “ecological disaster” that would induce farmers to buy dicamba-tolerant seeds. Key documents from that case can be found below.

The EPA’s Office of the Inspector General (OIG) plans to investigate the agency’s approvals of new dicamba herbicides to determine whether the EPA adhered to federal requirements and “scientifically sound principles” when it registered the new dicamba herbicides.

Federal Action

Separately, on June 3, 2020. the U.S. Court of Appeals for the Ninth Circuit said the Environmental Protection Agency had violated the law in approving dicamba herbicides make by Bayer, BASF and Corteva Agrisciences and overturned the agency’s approval of the popular dicamba-based herbicides made by the three chemical giants. The ruling made it illegal for farmers to continue to use the product.

But the EPA flouted the court ruling, issuing a notice on June 8 that said growers could continue to use the companies’ dicamba herbicides until July 31, despite the fact that the court specifically said in its order that it wanted no delay in vacating those approvals. The court cited damage done by dicamba use in past summers to millions of acres of crops, orchards and vegetable plots across U.S. farm country.

On June 11, 2020, the petitioners in the case filed an emergency motion seeking to enforce the court order and to hold the EPA in contempt. Several farm associations have joined with Corteva, Bayer and BASF in asking the court not to immediately enforce the ban. Documents are found below.

Background

Dicamba has been used by farmers since the 1960s but with limits that took into account the chemical’s propensity to drift and volatilize- moving far from where it was sprayed. When Monsanto’s popular glyphosate weed killing products, such as Roundup, started losing effectiveness due to widespread weed resistance, Monsanto decided to launch a dicamba cropping system similar to its popular Roundup Ready system, which paired glyphosate-tolerant seeds with glyphosate herbicides. Farmers buying the new genetically engineered dicamba-tolerant seeds could more easily treat stubborn weeds by spraying  entire fields with dicamba, even during warm growing months, without harming their crops. Monsanto announced a collaboration with BASF in 2011. The companies said their new dicamba herbicides would be less volatile and less prone to drift than old formulations of dicamba.

The Environmental Protection Agency approved the use of Monsanto’s dicamba herbicide “XtendiMax” in 2016. BASF developed its own dicamba herbicide that it calls Engenia. Both XtendiMax and Engenia were first sold in the United States in 2017.

Monsanto started selling its dicamba-tolerant seeds in 2016, and a key claim by the plaintiffs is that selling the seeds before regulatory approval of the new dicamba herbicides encouraged farmers to spray fields with old, highly volatile dicamba formulations. The Bader lawsuit claims: “The cause of such destruction to Plaintiff Bader Farms’ crops is Defendant Monsanto’s willful and negligent release of a defective crop system – namely its genetically modified Roundup Ready 2 Xtend soybeans and Bollgard II Xtend cotton seeds (“Xtend crops”) – without an accompanying, EPA-approved dicamba herbicide.”

Farmers claim that the companies knew and expected that the new seeds would spur such widespread use of dicamba that drift would damage the fields of farmers who did not buy the genetically engineered dicamba-tolerant seeds. The farmers allege this was part of a scheme to expand sales of the genetically engineered dicamba-tolerant seeds. Many allege the new dicamba formulations sold by the companies also drift and cause crop damage just as the old versions have done.

For more information about dicamba, please see our dicamba fact sheet.