EPA’s “scientific integrity” program lacks teeth, group alleges

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Insiders at the Environmental Protection Agency (EPA) have alleged dozens of violations of the agency’s “scientific integrity” policy over the last few years, including complaints of political interference and tampering with chemical risk assessments, but nearly all the complaints have been ignored, according to an analysis conducted by a nonprofit group representing EPA employees.

Seven complaints were filed very recently- between January and July of this year, according to EPA data obtained by the group.

Since 2017 there have been a total of 68 allegations of scientific integrity violations inside the EPA, including 35 allegations filed between 2019 and mid-year 2021, according to Public Employees for Environmental Responsibility (PEER).

PEER is currently representing four EPA scientists who have come forward as whistleblowers, offering internal agency emails and other documents as evidence of what they allege is wide-spread corruption driven by powerful political and corporate influences.

Among other things, those whistleblowers have claimed specifically that chemical risk assessments have been altered, or otherwise tampered with, in order to make chemicals entering the marketplace appear safer than they actually are. The result leaves the public exposed to chemicals that may cause cancer, developmental problems or other hidden health risks.

Importantly, the whistleblowers have said that agency misconduct has continued through the first several months of the Biden administration.

The information obtained by PEER shows that of the 35 allegations filed from 2019 through June 2021, 12 were closed, 22 remained unresolved and only one was deemed “substantiated,” but even that one has not led to any punishment.

“It’s a complete sham,” Jeff Ruch, one of PEER’s regional directors and former executive director, said of the EPA’s scientific integrity program. “They give the illusion that they have a program, but it’s worse than nothing because it suggests they’re holding themselves to a high standard of scientific integrity when they’re not.”

Interference

The EPA has publicly reported scientific integrity complaint information through 2018, but has not filed public reports for complaint information since. The data for 2019 through June of 2021 was procured by PEER through a Freedom of Information Act request. The nonprofit requested details about the complaints and their handling but EPA provided only very limited information illustrated in pie charts.

The information in the pie charts shows that “interference” in scientific work ranked as the most often-cited type of complaint. Five of the seven complaints recorded for the first half of 2021 were for interference, for instance.

Shortly after taking office, President Biden launched a review of federal scientific integrity policies, saying “Scientific findings should never be distorted or influenced by political considerations.”

The directive said ”Improper political interference in the work of Federal scientists… undermines the welfare of the Nation, contributes to systemic inequities and injustices, and violates the trust that the public places in government to best serve its collective interests.”

In one example of such interference, PEER filed a complaint last year with the EPA’s Office of  Inspector General charging that then EPA Administrator Andrew Wheeler, along with other high-ranking EPA officials, excluded key scientific information and the analysis of experts​ in changing the definition of “water of the United States” under the Clean Water Act, a move PEER and others said threatened clean drinking water around the country. 

“Major” hindrances

PEER describes what it calls “major” hindrances within the EPA’s Scientific Integrity program, including a “lack of investigative staff,” an “inability to draw upon expertise needed to assess technical issues,” and the “absence of any protocol for reviewing or investigating complaints.”

And notably, violations of the agency’s scientific integrity policy carry no penalties, PEER said.  The group’s experience representing whistleblowers indicates violations are largely addressed by trying to “persuade non-compliant managers to address their own violations,” PEER said.

The group said with respect to the current whistleblower complaints PEER is involved in, the EPA scientists notified the agency’s office of scientific integrity last November about their concerns about a memorandum that made policy changes they scientists said weakened human health assessments in a way that made them less likely to find risks with a new chemical substance. Their concerns were ignored for months, according to PEER. The memorandum was eventually revoked, but the altered chemical assessments were not corrected and the scientists fear the policy memo will be reinstituted, according to PEER.

In the EPA’s 2018 report, the agency said that “Scientific integrity remains an ongoing priority for EPA,” and said the agency works with special advisors and committees and engages the Office of Inspector General (OIG) when needed to protect and advance the integrity of the agency’s scientific work.

“Scientific integrity is the compass that guides EPA in its mission to protect human health
and the environment,” the agency states in the report.

Cancer patient lawyer spars with Monsanto scientist in California Roundup trial

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A lawyer for a woman claiming her use of Roundup herbicide caused her to develop non-Hodgkin lymphoma sparred with a longtime Monsanto scientist in court on Wednesday, forcing the scientist to address numerous internal corporate documents about research showing Monsanto weed killers could be genotoxic and lead to cancer.

The testimony by former Monsanto scientist Donna Farmer marked her second day on the stand and  came several weeks into the case of Donnetta Stephens v. Monsanto, the fourth Roundup trial in the United States, and the first since 2019. Juries in three prior trials all found in favor of plaintiffs who, like Stephens, alleged they developed non-Hodgkin lymphoma due to their use of Roundup or other Monsanto herbicides made with the chemical glyphosate. Thousands of people have filed similar claims.

Bayer AG, which bought Monsanto in 2018, has earmarked more than $14 billion to try to settle all of the U.S. Roundup litigation, but many plaintiffs have refused to settle, and cases continue to go to trial.

A “genotox hole”

In hours of contentious back-and-forth, interrupted repeatedly by objections from a Monsanto attorney, Stephens’ lawyer William Shapiro quizzed Monsanto toxicologist Donna Farmer about emails and documents dating back to the late 1990s that focused on research – and the company’s handling of that research – into whether or not the company’s herbicide products could cause cancer.

In one line of questioning, Shapiro asked Farmer about emails in which she and other company scientists discussed the company’s response to outside research that concluded the company’s glyphosate-based herbicides were genotoxic, meaning they damaged human DNA. Genotoxicity is an indicator that a chemical or other substance may cause cancer.

Shapiro focused during one series of questions on work done by a scientist named James Parry, who Monsanto hired as a consultant in the 1990s to weigh in on the genotoxicity concerns about Roundup being raised at the time by outside scientists. Parry’s report agreed there appeared to be “potential genotoxic activity” with glyphosate, and recommended that Monsanto do additional studies on its products.

In an internal Monsanto email dating from September 1999 written to Farmer and other company scientists, a Monsanto scientist named William Heydens said this about Parry’s report: “let’s step back and look at what we are really trying to achieve here. We want to find/develop someone who is comfortable with the genetox profile of glyphosate/Roundup and can be influential with regulators and Scientific Outreach operations when genetox issues arise. My read is that Parry is not currently such a person, and it would take quite some time and $$$/studies to get him there. We simply aren’t going to do the studies Parry suggests.”

In a separate email revealed through the litigation, Farmer wrote that Parry’s report put the company into a “genotox hole” and she mentioned a suggestion by a colleague that the company should “drop” Parry.

Farmer testified that her mention of a “genotox hole” referred to problems with “communication” not about any cancer risk. She also said that she and other Monsanto scientists did not have concerns with the safety of glyphosate or Roundup, but did have concerns about how to respond to paper and research by outside scientists raising such concerns.

Shapiro pressed Farmer on her reaction to Parry’s finding: “You thought it would be okay on behalf of Monsanto to receive information as you did from Dr. Parry that this Roundup product was genotoxic or could be, you thought it would be okay to go ahead and continue to sell the product, correct?”

Farmer replied: “We didn’t agree with Professor Parry’s conclusions at the time that it may be, could be, capable of being genotoxic. We had other evidence….  We had regulators who had agreed with our studies and conclusions that it was not genotoxic.”

Her answer was interrupted as Shapiro objected, saying he was asking a yes or no question and Farmer’s attempt to respond beyond that should be stricken. The judge agreed and struck part of the response.

Continuing his questioning, Shapiro asked: “Well that didn’t work out to have Dr. Parry be the spokesperson for Monsanto, did it Dr. Farmer?

“I would disagree with you because there is still a lot more to this Professor Parry, working with him, and I’d be happy to…” Farmer replied before being cut off by another Shapiro objection and the judge’s striking of everything following the first five words.

A similar pattern played out throughout Farmer’s testimony as Stephens’ lawyer objected to Farmer’s attempts to provide extended answers to multiple questions posed, and Monsanto’s lawyer Manuel Cachan objecting repeatedly to Shapiro’s questions as “argumentative.”

Ghostwriting and “FTO”

Shapiro asked Farmer to address multiple issues expressed in the internal corporate emails, including one series in which Monsanto scientists discussed ghostwriting scientific papers, including a very prominent paper published in the year 2000 that asserted there were no human health concerns with glyphosate or Roundup.

Shapiro additionally asked Farmer to address a strategy Monsanto referred to in emails as “Freedom to Operate” or “FTO”. Plaintiffs’ lawyers have presented FTO as Monsanto’s strategy of doing whatever it took to lessen or eliminate restrictions on its products.

And he asked her about Monsanto emails expressing concerns about research into dermal absorption rates – how fast its herbicide might absorb into human skin.

Farmer said multiple times that information was not being presented in the correct context, and she would be happy to provide detailed explanations for all of the issues raised by Shapiro, but was told by the judge she would need to wait until questioning by Monsanto’s lawyers to do so.

Zoom trial

The Stephens trial is taking place under the oversight of Judge Gilbert Ochoa of the Superior Court of San Bernardino County in California. The trial is being held via Zoom due to concerns about the spread of Covid-19, and numerous technical difficulties have plagued the proceedings. Testimony has been halted multiple times because jurors have lost connections or had other problems that inhibited their ability to hear and view the trial testimony.

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.

Litigation against Syngenta grows; lawyers fight over evidence and trial dates

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Syngenta AG is facing a growing number of U.S. lawsuits over allegations that its paraquat herbicide causes Parkinson’s disease, with a Fresno, California man pushing for an expedited trial that potentially would start within the next few months, and multiple plaintiffs’ lawyers jockeying for power and influence over future trial proceedings.

Plaintiff George Isaak used paraquat to treat weeds on orchard and vineyard property from 1964 through 2004, mixing, loading and spraying the pesticide routinely before he was diagnosed with Parkinson’s in May of 2020, according to his lawsuit.

Isaak used a 200-gallon “spraying rig” on the 60-acre farm where he raised peaches, nectarines, almonds, pistachios, and grapes before retiring in 2005. Isaak, 84, now has such severe Parkinson’s symptoms that he has suffered several falls, finds it hard to speak, and is confined to a wheelchair, according to his lawyers.

Isaak attorney Mike Miller said his client has been left with “horrible” injuries from Parkinson’s.

Isaak should now be given a trial date no later than January due to his decline in cognition and overall debilitation to his health, according to a court filing by The Miller Firm and co-counsel.

Isaak “had no reason to suspect that chronic, low-dose exposure to Paraquat could cause neurological diseases such as Parkinson’s disease,” the lawsuit states. But evidence will show, the lawsuit contends, that the paraquat use was a “substantial factor in causing Plaintiff George Isaak to suffer severe and permanent physical injuries, pain, mental anguish, and disability, and will continue to do so for the remainder of Plaintiff George Isaak’s life.”

Carol Isaak, George Isaak’s wife, is also a plaintiff in the lawsuit and is seeking a claim for loss of consortium.

There are hundreds of cases pending in state and federal courts around the country, according to a June 22 court filing. The plaintiffs in those cases all allege Syngenta was aware of the risks but failed to warn users.

Syngenta, which is owned by a Chinese chemical company, has denied the allegations, and is seeking to dismiss, or limit the lawsuits. The company filed a “partial motion to dismiss” in federal court on Sept. 13, citing various state law provisions in asking the court to dismiss claims “for breach of warranty, fraud, and violation of certain consumer protection statutes.”

Along with Syngenta, the defendants include Chevron Phillips Chemical Company LP, and Chevron USA, Inc. All have denied any liability.

Infighting among plaintiffs’ lawyers

Syngenta said in a Sept. 17 court filing that it opposes the granting of an expedited trial, known as a “preference” trial, for Isaak.

“Mr. Isaak has presented no evidence regarding his alleged paraquat exposures, and his medical records and doctor’s declaration cast doubt on whether he actually has Parkinson’s disease,” the company said in its filing.

Syngenta noted that there are many other plaintiffs expected to request preference trials.

In addition to the objection from Syngenta, Isaak’s lawyers effort to obtain court approval for a preference trial has come into conflict with an effort by other attorneys representing other plaintiffs in the paraquat litigation.

Plaintiffs law firm Walkup, Melodia, Kelly & Schoenberger is seeking to create a special committee made up of plaintiffs’ lawyers that would evaluate and screen cases seeking preference trials. Typically such requests for expedited trials go directly to a judge.

The firm said a committee was needed because many of the plaintiffs in the overall paraquat litigation would “likely qualify” for preference. They are proposing a protocol implemented by a five-member committee of plaintiffs’ lawyers.

“The majority of the plaintiffs, including both filed and unfiled cases known to plaintiffs’ counsel, are over the age of 65. The reality of these cases is that there are many plaintiffs, as well as many potential plaintiffs, whose disease progression is unstable and who have a real and substantial danger of losing their ability to testify, or losing their ability to meaningfully utilize their compensation, if their trials are not prioritized,” the firm stated in a court filing.

The firm added in a separate filing: “An uncontrolled race to file competing preference motions risks sending a plaintiff to trial who does not represent the plaintiff population. And should the initial trials be ultimately unsuccessful, it jeopardizes the rights of all remaining plaintiffs in the proceeding.”

Isaak’s lawyers oppose the formation of such a committee and filed a memorandum explaining that opposition on Sept. 17, arguing that the use of a preference committee is “unconstitutional on its face.”

Whether or not a plaintiff meets the criteria deserving of a preference trial should not be left up to the arbitrary nature of a committee of other plaintiffs’ attorneys, they said.

The attorneys registering opposition to the preference committee additionally allege that the Walkup firm has a conflict of interest because it has already reached a “large, lucrative” settlement agreement with Syngenta for some of its clients, and until that deal is finalized, Syngenta and the other defendants still could walk away from the deal.

Thus, the Walkup firm is “a conflicted law firm,” the attorneys allege. In addition to The Miller Firm, the law firms registering opposition are the Wagstaff Law Firm and Brady Law Group.

A hearing on the matter is set for Sept. 30.

Battle over discovery documents

The lawyers for plaintiffs have also been fighting over access to internal Syngenta corporate documents and other evidence obtained as part of court-ordered “discovery.”

Over the last few years, Syngenta and the other defendants turned over millions of documents to Missouri lawyer Steve Tillery in his representation of a paraquat lawsuit titled Hoffman V. Syngenta, that was pending in St. Clair County, Illinois. The Hoffman case had been set to go to trial earlier this year but Tillery and the defendants agreed to a settlement and no trial was held.

The lawyers for the plaintiffs pursuing trials want to make use of the materials already turned over in the Hoffman case, including internal corporate documents as well as depositions and expert reports. Tillery and Syngenta objected to sharing some of the materials but were ordered to do so by the federal judge overseeing consolidated paraquat proceedings in the Northern District of California.

Scientific studies

Several scientific studies have linked paraquat to Parkinson’s, including a large study of U.S. farmers jointly overseen by multiple U.S. government agencies.  Farmers use paraquat in the production of many crops, including corn, soy and cotton. The Agricultural Health Study (AHS) said it found that “exposure to agricultural pesticides may increase a person’s risk of developing Parkinson’s disease.” In 2011, AHS researchers reported that “participants who used paraquat or rotenone were twice as likely to develop Parkinson’s disease as people who didn’t use these chemicals.”

Syngenta argues that newer and more robust research, including by AHS scientists, has discounted a tie between paraquat and Parkinson’s.

A recent paper from AHS researchers stated that “Extensive literature suggests an association between general pesticide use and Parkinson’s disease (PD). However, with few exceptions, little is known about associations between specific pesticides and PD.”

Because the paraquat litigation is expected to continue to grow, the U.S. Judicial Panel on Multidistrict Litigation (MDL) in Washington, D.C. approved the consolidation of pretrial proceedings in the U.S. District Court in the Southern District of Illinois under the oversight of Chief Judge Nancy Rosenstengel.

Similarly, several other cases are consolidated in Judicial Council Coordination Proceedings in Contra Costa County Superior Court in California.

Monsanto lawyer cross-examines cancer patient over her claims Roundup caused her disease

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A California woman suing Monsanto over allegations that her use of Roundup weed killer caused her to develop cancer testified Monday that she had a hard time remembering many details about the extent of her use of the pesticide, struggling to answer several questions posed by a Monsanto attorney.

In cross examination, Monsanto attorney Bart Williams pressed plaintiff Donnetta Stephens on how much and when she had used the company’s popular herbicide before she was diagnosed with non-Hodgkin lymphoma in 2017. Peppering Stephens with questions about changes in information she provided in depositions and interrogatories, the company’s lawyer sought to cast doubt on the span and volume of her actual use and exposure.

In testimony last week, Stephens’ son David Stephens recalled his mother’s frequent use of Roundup 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 seeing that use continuing when he was an adult.

But in Monday’s testimony, Williams sought to undermine Donnetta Stephens credibility, implying that her son and husband were the architects of many of her answers about her use of Roundup provided in pre-trial documents.

He said that Stephens and her husband had “changed your story about the length of time you had used Roundup,” saying initially her use dated back to 2003 but then saying the use began in 1985.

Stephens acknowledged that her memories of her use were aided by information from her family.

“You and I agree that one should not swear to something, accuracy, if you don’t know whether it is true or not.  That is my question,” Monsanto’s lawyer addressed Stephens.

“At that time, I believed it to be true, yes sir,” she replied.

“You believed it to be true solely because that’s what your husband or your son said, correct?” Williams  asked.

“Yes,” Stephens answered.

The line of questioning was anticipated in a June filing by Stephens’ lawyers, explaining to the judge that Stephens is in frail health after six cycles of chemotherapy and has suffered significant memory loss, making her “unable to recall certain Roundup exposures.”

She had told lawyers initially that her exposure extended over 14 years but amended that to say it was  closer to 30 years after being reminded of her use of Roundup products at a property where she had previously lived, according to her lawyers.

In their June filing, Stephens lawyers said Monsanto’s attorneys were accusing them and Stephens of “engaging in gamesmanship,” and allegation they denied.

Stephens testified that she does remember that sometimes when she was spraying Roundup the wind would blow spray onto her bare skin. She said she would not immediately wash it off, showering only after she completed her yardwork.

“It was all over me,” Stephens said.

At one point Monsanto’s attorney asked Stephens about her relationship with her children. When Stephens insisted she was close to her children, Monsanto’s attorney played a video deposition of a previous statement she had made saying the opposite.

Longtime Monsanto scientist Donna Farmer is scheduled to testify Tuesday.

Monsanto is owned by Germany’s Bayer AG. Bayer bought Monsanto in 2018.

Preference case

Stephens’ trial is a “preference” case, meaning her case was expedited after her lawyers informed the court that Stephens was “in a perpetual state of pain” and losing cognition and memory.

The case is being tried in the Superior Court of San Bernardino County in California under the oversight of Judge Gilbert Ochoa. It 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.

Stephens trial is being held via Zoom due to concerns about the spread of Covid-19, and numerous technical difficulties have plagued the proceedings. On Monday, the trial was stopped several times because jurors lost connections or had other problems that inhibited their ability to hear and view the trial testimony.

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

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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 whistleblower testifies her advocacy for stronger health protections drew agency retaliation

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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

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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.