Son testifies about his mother’s cancer alleged due to Roundup exposure

Print Email Share Tweet

A woman suffering from non-Hodgkin lymphoma was a devoted user of Roundup herbicide for decades before she became ill, her son testified Tuesday in a California trial that marks the fourth such trial pitting a cancer victim against Roundup maker Monsanto.

Under questioning by a lawyer representing plaintiff Donetta Stephens, her son David Stephens recalled his mother’s frequent use of Roundup in the yard and her tendency to wear sleeveless shirts and shorts when outside spraying the weed killer. He described recalling her use when he was a child and that use continuing when he was an adult and had his own children.

Stephens also testified about a family gathering in which his mother broke the news of her cancer to the family, the lengthy series of medical treatments that followed, his mother’s memory loss and other treatment-related problems, and a period in which his mother was hospitalized multiple times and nearly died.

Stephens is one of tens of thousands of plaintiffs who filed lawsuits against Monsanto after the World Health Organization’s cancer experts in 2015 classified glyphosate as a probable human carcinogen with an association to non-Hodgkin lymphoma. Glyphosate is the active ingredient in Roundup and other weed killing brands.

Bayer AG bought Monsanto in June 2018 just as the first trial was getting underway.

Three previous trials held to date were all found in favor of the plaintiffs. Jurors in those trials agreed with claims that Monsanto’s glyphosate-based weed killers, such as Roundup, cause non-Hodgkin lymphoma, and that Monsanto spent decades covering up the risks and failing to warn users.

The Stephens case is being tried in the Superior Court of San Bernardino County in California under the oversight of Judge Gilbert Ochoa. Though the trial started in person, Judge Ochoa ordered the proceedings shifted to a Zoom trial due to concerns about the spread of Covid-19 virus.

In testimony Tuesday, David Stephens broke down, emotionally describing a time when it appeared his mother was near death, and speaking of a photo he took of her that he thought at the time would be the last.

“I took that picture because when you think that your mother is going to die and that could be the last picture…,” Stephens said haltingly. “I wanted to take that picture so I could remember…”

Donnetta Stephens is now in remission from cancer but has been left debilitated, her son testified.

Former Monsanto scientist Donna Farmer will be called to testify next week, according to Stephens’ lawyer Fletch Trammell.

Technical trouble

The trial has been plagued by technical issues since the transition to a virtual setting through Zoom. There have been multiple times proceedings have been halted because a lawyer or juror loses an audio or video connection or experiences other difficulties. The virtual format has also proven problematic at times for the presentation of certain exhibits.

A courtroom attendant has been assigned to monitor jurors to determine if they are paying attention, and to alert the judge to lost connections or other problems.

In Tuesday’s testimony, as Monsanto lawyer Manuel Cachan was attempting to cross examine Stephens, questioning the reliability of his memory regarding his mother’s use of Roundup, the technical trouble kicked in again.

“I’m sorry for the interruption, juror number 13 is having issues, just starting to quote unquote glitch out,” the courtroom attendant interjected.

Minutes later: “Pardon me… juror number 11 has just disconnected,” the courtroom attendant interrupted again.

Some legal observers have speculated that the losing party in the trial will have an easy avenue for appeal given the persistent interruptions and difficulties.

Trial overlap

A fifth Roundup trial was starting jury selection this week in a case involving a boy with non-Hodgkin lymphoma.

The child, Ezra Clark, is the subject of a trial beginning this week in Los Angeles County Superior Court. 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.

Opening statements in the Clark trial are scheduled to begin Wednesday morning.

Bayer denies any cancer connection

Bayer has earmarked more than $14 billion to try to settle the litigation and has announced it will stop selling glyphosate-based herbicides to consumers by 2023. But the company still insists that the herbicides it inherited from Monsanto do not cause cancer.

Last month Bayer filed a writ of certiorari with the U.S. Supreme Court, seeking the high court’s review of the Ninth Circuit Court of Appeals’ decision in the case of Hardeman v. Monsanto. 

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.

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.

EPA exposed for hiding chemical risks, favoring corporate interests

Print Email Share Tweet

Updates: EPA whistleblower trial ongoing the week of September 13, 2021

The U.S. Environmental Protection Agency (EPA) has a long and well-documented history of questionable conduct when it comes to regulation of chemicals important to the profit centers for many large and powerful corporations.  Numerous examples show a pattern of agency actions that allow for the use of dangerous chemicals by consumers, farmers, groundskeepers and others despite evidence of harm.

Documents and other evidence, including information provided in public disclosures by multiple EPA scientists, reveals actions in which EPA managers have intentionally covered up risks associated with certain chemicals. According to the evidence from these EPA insiders, pressure from chemical manufacturers, chemical industry lobbyists and from certain U.S. lawmakers drives internal agency manipulations that protect corporate interests but endanger public health.

Evidence indicates the misconduct dates back decades and has occurred in administrations led by Democrats and Republican alike.

A research project sponsored by Harvard University’s Edmond J. Safra Center for Ethics said while the EPA has “many dedicated employees who truly believe in its mission,” the agency has been “corrupted by numerous routine practices,” including a “revolving door” between EPA and industry in which corporate lawyers and lobbyists gain positions of agency power; constant  industry lobbying against environmental regulations; pressure from  lawmakers who are beholden to donors; and meddling by the White House.

Blowing the whistle

The Frank R. Lautenberg Chemical Safety for the 21 Century Act, signed into law on June 22, 2016, was the first substantive reform to Toxic Substances Control Act (TSCA). The law requires EPA to make an affirmative determination on whether a new chemical substance presents an “unreasonable risk” to human health or the environment under “known, intended or reasonably foreseen conditions of use.” See information here for more information.

Despite the law, the EPA has failed to make valid determinations about the risk presented by numerous chemicals.

In June 2021, four EPA scientists, each working within the agency’s Office of Chemical Safety and
Pollution Prevention (OCSPP), publicly accused the the EPA of deliberate tampering with chemical risk assessments. The four whistleblowers made their complaints public through a group called Public  Employees for Environmental Responsibility (PEER).

In a June 28 letter to the U.S. House Committee on Oversight and Reform, PEER said the four EPA scientists were providing “disturbing evidence of fraud and corruption,” involving “deliberate tampering with chemical risk assessments conducted under the Toxics Substances Control Act (TSCA), including PFAS (a.k.a. “forever chemicals”), and the deletion of potential health effects without the knowledge or consent of the human health assessors.”

The letter further states:

“All four clients have experienced numerous instances where their risk assessments were changed
by their managers or by colleagues in response to direction by management. These changes
include –
● Deleting language identifying potential adverse effects, including developmental toxicity,
neurotoxicity, mutagenicity, and/or carcinogenicity;
● Major revisions that alter the report conclusions to indicate that there are no toxicity
concerns despite data to the contrary; and
● Risk assessments being reassigned to inexperienced employees in order to secure their
agreement to remove issues whose inclusion would be protective of human health.”

As a result of the manipulations, people who work with these chemicals are not receiving information they need to protect themselves, such as “proper handling procedures, personal protection needed, accidental release measures, and first aid and firefighting measures,” according to PEER.
This is a particular concern for pregnant women, according to the PEER complaint.

Erasing important information

On August 26, 2021, PEER filed a separate complaint alleging that the EPA has been breaking the law by erasing original versions of internal communications and draft documents and retaining only the final version of key documents. The practice violates the Federal Records Act by eliminating details of the decision-making process from outside review, according to PEER.

PEER states that that discarding of documents trails is not only contrary to law but also violates the EPA’s own records retention policy. According to PEER, its complaint focuses on two classes of documents:

  • Alterations of chemical risk assessments by managers in which both the identity of the manager and the alterations themselves are not apparent; and
  • Internal comments related to the development of its Waters of the United States (WOTUS) rule, in which EPA software overwrote the original and all prior versions any time there was an edit. Thus, only the “final” version was saved.

“It is as if EPA memorializes its internal decision-making in disappearing ink,” PEER Executive Director Tim Whitehouse, a former EPA enforcement attorney, said in a press release. “EPA’s record-keeping practices allow unknown officials to make changes while disguising what precisely was changed and who changed them.”

PEER said it has asked the National Archives and Records Administration to intervene to prevent the EPA from destroying more records and to adopt safeguards to prevent any recurrences.

The case of Ruth Etzel

Ruth Etzel,  former director of the EPA’s Office of Children’s Health Protection (OCHP), filed a  whistleblower complaint with the U.S. Merit Systems Protection Board contending she was subject to illegal retaliation in 2018 and 2019. Etzel said the agency retaliated against her after she complained publicly about what she said was  EPA resistance to stronger public protections against lead poisoning.

At the EPA it was Etzel’s job to determine the impacts of regulations on children. But she alleges she was improperly removed from her position after speaking out about EPA failures, and was assigned to a division where she was not allowed to work on prevention of lead poisoning.

Etzel is both a pediatrician and an epidemiologist and is recognized internationally as an expert on child health and the environment. She was named the 2021 winner of the Public Policy and Advocacy Award by the Academic Pediatric Association.

More than 120 environmental and health organizations  complained to EPA about Etzel’s removal, saying the agency was sending a “signal that children’s health is not a priority for the agency.”

Reporting on EPA’s misconduct

See here information, including news articles, regarding alleged EPA misconduct and regulatory failures:

‘The harm to children is irreparable’: Ruth Etzel speaks out ahead of EPA whistleblower hearing, Carey Gillam, The Guardian, September 12, 2021

The EPA’s rationale for banning chlorpyrifos may make it harder to eliminate other brain-harming pesticides , Sharon Lerner, The Intercept, August 24, 2021.

Formaldehyde causes leukemia, according to EPA assessment suppressed by Trump officials, Sharon Lerner, The Intercept, August 19, 2021.

EPA exposed: Leaked audio shows pressure to overrule scientists in “hair-on-hire” cases,  Sharon Lerner, The Intercept, August 4, 2021.

Whistleblowers expose corruption in EPA chemical safety office, Sharon Lerner, The Intercept, July 2, 2021.

How pesticide companies corrupted the EPA and poisoned America, Sharon Lerner, The Intercept, June 30, 2021.

Flawed analysis of an intentional human dosing study and its impact on chlorpyrifos risk assessment,  Lianne Sheppard, Seth McGrew, Richard Fenske, Environment International, July 2020.

Further Efforts Needed to Uphold Scientific Integrity Policy at EPA,  U.S. Environmental Protection Agency Office of Inspector General, May 20, 2020.

EPA Allowed Companies to Make 40 New PFAS Chemicals Despite Serious Risks, Sharon Lerner, The Intercept, September, 19, 2019.

E.P.A. Won’t Ban Chlorpyrifos, Pesticide Tied to Children’s Health Problems, Lisa Friedman, New York Times, July 18, 2019.

Emails show Trump EPA overruled career staff on Wisconsin air pollution, Timothy Gardner, Reuters, May 28, 2019.

US environment agency cuts funding for kids’ health studies, Sara Reardon, Nature, May 13, 2019.

Meet 3 women who stood up to Trump to protect the American people — and lost their jobs,  The Hill, January 19, 2019.

White House, EPA headed off chemical pollution study, Annie Snider, Politico, May 14, 2018.

Whitewash: The Story of a Weed Killer, Cancer, and the Corruption of Science, Carey Gillam, Island Press, October 10, 2017.

Records Show EPA Efforts to Slow Herbicide Review Came in Coordination with Monsanto, Carey Gillam, Huffington Post, August 18, 2017.

EPA Official Accused of Helping Monsanto “Kill” Cancer Study, Joel Rosenblatt, Lydia Mulvany, and Peter Waldman, Bloomberg, March 14, 2017.

Poison Spring- The Secret History of Pollution and the EPA, Evaggelos Vallianatos and McKay Jenkins, Bloomsbury Press, April 14, 2014.

EPA whistleblower testifies her advocacy for stronger health protections drew agency retaliation

Print Email Share Tweet

Children’s health expert Ruth Etzel on Monday testified in a public hearing that the Environmental Protection Agency (EPA) worked to silence and harass her, removing her from a top-level position after she complained about agency delays in advancing a lead poisoning prevention program.

In testimony before Merit Systems Protection Board Judge Joel Alexander,  Etzel described being shocked to learn she was being placed on leave without pay in September 2018 and the “vindictive” “cat and mouse games” she alleged EPA officials used to block her from scheduled national and international speaking engagements.

She also testified that the agency issued public statements designed to discredit and intimidate her.

“They appeared to be just trying to smear my good name,” she testified.

Etzel is a pediatrician and epidemiologist who was brought into the EPA in 2015 by the Obama administration to direct the agency’s Office of Children’s Health Protection (OCHP). Etzel previously worked as a senior officer in the department of public health and environment at the World Health Organization in Switzerland and also previously worked for the U.S. Centers for Disease Control and on public health matters within the U.S. Department of Agriculture.

The agency actions against her occurred during the Trump administration and allegedly followed an aggressive push by Etzel to launch a federal action plan aimed at reducing childhood exposures to lead.

According to her whistleblower complaint, Etzel spoke out about “gross mismanagement and a substantial and specific danger to public health” from childhood lead poisoning, and tried to promote the release of a new federal strategy even after EPA leadership delayed the plan’s final review. In response, “EPA placed Dr. Etzel on administrative leave without warning,” fabricated complaints about her leadership and obstructed her ability to travel to attend and speak at professional conferences, Etzel alleges.

Separate from Etzel’s allegations, four EPA scientists have recently come forward with allegations that the agency is putting corporate interests ahead of public health protection, allowing dangerous chemicals into the marketplace. The whistleblowers allege the EPA routinely uses intimidation tactics to coerce agency scientists into ignoring data showing risks of harm with certain chemicals, and/or altering assessments to downplay such risks.

Etzel and the other EPA whistleblowers are represented by lawyers at Public Employees for Environmental Responsibility. 

“Opportunity to strike”

Multiple internal EPA emails and other records were introduced on Monday as evidence, including an email in which EPA public affairs personnel discussed “an opportunity to strike” out against Etzel in communications to the media.

In a September 28, 2018 email, former EPA deputy associate administrator in the office of public affairs John Konkus wrote to colleagues about inquiries from members of the press about Etzel’s being placed on leave.

“This is our opportunity to strike,” Konkus wrote. (Konkus is no longer with the EPA; he now works as a senior manager for “government affairs” with AECOM, a consulting firm on infrastructure engineering and construction matters.)

“I felt like this was a direct strike on me and it caused me to have fear in my heart,” Etzel testified.

In an email thread with the subject line “Push this around ASAP please,” public affairs officials discussed a “stronger updated” statement about Etzel to state that she was placed on administrative leave because of “serious reports made against her by staff … ” that were “very concerning.”

After being put on leave, Etzel went on multiple television shows to talk about the agency actions. In testimony Monday she said she felt she had no other choice.

“I had been completely silenced by being placed on administrative leave and I was not able to do the job that I was hired to do. I had no other venue,” Etzel testified. “I basically took an oath when I became a doctor to do no harm and by being silent when hazards continue in the environment unabated I do harm, and so I’m not willing to do that. I had to speak out.”

Etzel said the lead plan that was ultimately rolled out after she was placed on leave was “weaker” than the one she helped design and lacked new regulations and requirements needed for the strategy to be  effective.

Former EPA official testifies

The first witness called Monday to testify on behalf of Etzel was former EPA official Reginald Allen, who served in several positions at the agency, including as Acting Deputy Chief of Staff.

Allen testified that during the Trump administration, Millan Hupp, a political appointee close to then-EPA administrator Scott Pruitt, “absolutely” engaged – along with Pruitt – in unethical behavior, and was at least partly instrumental in working to push out certain EPA personnel. Pruitt, who was appointed by Trump to run the EPA, was pushed out in July of 2018 amid evidence of multiple ethical violations.

Allen further testified that Helena Wooden-Aguilar, who was acting deputy chief of staff at the time and who was directly involved in removing Etzel, was close to Hupp and was given that position “with an agenda and that agenda included pushing aside or getting rid of the career senior executives that the political administration did not feel comfortable with or felt did not do their bidding in a way that they wanted.”

Under questioning, Allen added: “I believe it was to remove what they felt were politically unreliable career leadership in the agency… so they wouldn’t be privy to some of the things that went on in the office of the administrator.”

Wooden-Aguilar is scheduled to testify on Tuesday or Wednesday.

Allen said that when he raised concerns about ethical matters within the EPA “it was just not appreciated” and “marked” him within the agency. Allen said at one point he was falsely accused of leaking sensitive agency information to the media.

“There was even an article planted about me from the administration in the conservative press saying that I was leaking information,” Allen said. “They later determined that it was one of their own… political folks that was doing that. But the damage was already done.”

EPA defense

One witness called Monday afternoon, “leadership consultant” Catherine Allen, appeared to bolster the EPA’s position that there was no improper retaliation against Etzel and her removal from the children’s health office was due to poor leadership and complaints about her management of that office.

The EPA asserts there were many complaints about Etzel’s management, including allegations from employees that she “failed to follow agency HR policy,” was emotional and would “bully” co-workers.

Allen testified that she determined Etzel had poor management abilities and “had lost the respect, the trust, the confidence” of those she managed.

Allen confirmed her findings in a report that stated: “It is my view that Ms. Etzel cannot effectively perform her duties… the longer she is allowed to stay in this role the more the agency is exposed to legal and operational risk. The staff deserve better.”

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

Print Email Share Tweet

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

Print Email Share Tweet

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

Print Email Share Tweet

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

Print Email Share Tweet

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.

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

Print Email Share Tweet

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

Print Email Share Tweet

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

Print Email Share Tweet

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.