U.S. Supreme Court sets date to consider review of Monsanto Roundup case

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Bayer AG’s effort to get the U.S. Supreme Court to review a key trial loss in the nationwide Roundup litigation inched forward this week when the high court said it would include Bayer’s petition for a writ of certiorari in a December 10 conference where the justices will discuss which cases to accept for review.

Bayer, which bought Monsanto in 2018, filed the petition in August, asking the court to review the Ninth Circuit Court of Appeals’ decision that affirmed the district court’s judgment in Monsanto’s 2019 trial loss to plaintiff Edwin Hardeman. The jury in the case found that exposure to Monsanto’s glyphosate-based herbicide was a cause of Hardeman’s non-Hodgkin lymphoma (NHL).

Hardeman’s attorneys 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. Hardeman’s attorneys argued that instead of hiding information, Monsanto should have warned consumers about the risks that its products could cause cancer.

Two key issues

Bayer maintains Monsanto’s glyphosate herbicides do not cause cancer, and it additionally argues that  the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which governs the registration, distribution, sale, and use of pesticides in the United States, preempts “failure-to-warn” claims by Hardeman and other plaintiffs in the Roundup litigation. Because the Environmental Protection Agency (EPA) has approved labels with no cancer warning, failure-to-warn claims should be barred, the company maintains.

In addition to the FIFRA issue, the company petition filed in August urged the Supreme Court to also 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 response to Bayer’s petition that the Supreme Court review the case, Hardeman’s attorneys filed a reply brief arguing the company’s request “is unworthy of review,” mischaracterizes elements of the case, and the company’s petition should be denied.

No certainty

There is no certainty the Supreme Court will agree to take up the case; nor a certainty that there will even be much discussion of the case, but if the court does decide to grant the company’s request, it would shine a national spotlight on the product liability litigation that has seen more than 100,000 plaintiffs sue over allegations Roundup herbicide causes cancer.

A favorable Supreme Court decision is widely seen as Bayer’s best hope for putting an end to the Roundup litigation, which has attracted tens of thousands of plaintiffs, all alleging they developed NHL due to exposure to Monsanto’s herbicides.

Several organizations have joined in the request for Supreme Court review of the Hardeman decision, including the industry lobbying group CropLife America, The Chamber of Commerce of the United States of America; Pharmaceutical Research and Manufacturers of America; the American Tort Reform Association; the Product Liability Advisory Council; the Washington Legal Foundation; and Lawyers for Civil Justice.

The Supreme Court typically takes fewer than 200 cases out of thousands of case review requests each year, and favors accepting cases that have national significance, or deal with conflicting decisions in lower courts and those that are seen as setting an important precedent.

PFAS: Health Concerns and Efforts to Regulate “Forever Chemicals”

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Per- and Polyfluoroalkyl Substances (PFAS) are a group of thousands of manufactured chemicals widely used by a range of industries and commonly found in a large number of household products. One common characteristic of PFAS is that they persist in the environment and can accumulate in humans and animals. For this reason, they are often referred to as “forever chemicals.”

Some PFAS have been linked to cancer, birth defects, liver disease, thyroid disease, decreased immunity, hormone disruption and a range of other serious health problems. 

The U.S. Centers for Disease Control and Prevention (CDC) says that most people in the United States have been exposed to some PFAS. The chemicals  have been documented in the blood of people and animals around the world, and also have been found to be pervasive in the environment, particularly in areas where manufacturers or other industrial users are actively handling PFAS. 

In response to a Freedom of Information Act request, the U.S. Environmental Protection Agency (EPA) in 2021 released a spreadsheet of more than 120,000 facilities around the United States the regulatory agency fears are handling PFAS. Download that spreadsheet here. 

Researchers have identified the following routes of exposure to PFAS:

  • Drinking water – in public drinking water systems and private drinking water wells.
  • Soil and water at or near waste sites – at landfills, disposal sites, and hazardous waste sites.
  • Fire extinguishing foam – used in training and emergency response events at airports, shipyards, military bases, firefighting training facilities, chemical plants, and refineries.
  • Manufacturing or chemical production facilities that produce or use PFAS – such as oil and gas drilling sites, chrome plating, electronics, and certain textile and paper manufacturers.
  • Food – such as fish caught from water contaminated by PFAS and dairy products from livestock exposed to PFAS, and other foods.
  • Food packaging – such as grease-resistant paper, fast food containers/wrappers, microwave popcorn bags, pizza boxes, and candy wrappers.
  • Household products- such as stain and water-repellent used on carpets, upholstery, clothing, and other fabrics; cleaning products; non-stick cookware; paints, varnishes, and sealants.
  • Personal care products- such as shampoos, dental floss, and cosmetics.

Long history of warnings about health risks of PFAS  

Environmental and human health experts and advocates have long been critical of the EPA for a lack of research into, and regulation of, PFAS. Researchers, lawyers and environmental and human health advocates have warned about the dangers of PFAS for roughly 20 years, and evidence has come to light showing that companies involved in manufacturing PFAS have known about dangers to human health even longer. 

Research has demonstrated that two types of PFAS – Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS), are very harmful to humans and animals. In 2016, the National Toxicology Program (NTP) concluded that PFOA and PFOS were a specific hazard to immune system function in humans. U.S. manufacturers have been replacing those types of PFAS with other types, though concerns persist about the replacements.  

On Nov. 16, 2021, the EPA said it was sending four “draft documents” to its Scientific Advisory Board that contain new data and analyses. The new information indicates that “negative health effects may occur at much lower levels of exposure to PFOA and PFOS than previously understood and that PFOA is a likely carcinogen,” according to the EPA.

PFOA, also known as C8, was a key ingredient in non-stick Teflon products. C8 was originally manufactured by 3M and then by DuPont until the health hazards of the chemical were made public through a class-action lawsuit. A replacement chemical called GenX was introduced by DuPont in 2009 as a safer alternative to PFOA, but an investigation by The Intercept found that DuPont filed 16 reports with the EPA citing numerous harmful health effects of the chemical on animals, sparking concerns about the safety of the substitute.  

A C8 science panel was formed as part of the settlement of a class-action lawsuit approved in February 2005 by West Virginia Circuit Court. That case involved allegations that human health problems were caused by releases of C8 from a DuPont facility in West Virginia.

The science panel was charged with conducting a community study to help evaluate potential links between C8 exposure and any human disease. The research findings are detailed here.

The litigation and settlement were largely the work of U.S. lawyer Robert Bilott.

Bilott has spent the last two decades advocating for strict PFAS regulation and corporate accountability for PFAS pollution. His investigation into PFAS, including the corporate efforts to cover up the harms of the chemicals, have been documented in a book, a feature film and a documentary film, among other works.

In 2018, the U.S. Centers for Disease Control and Prevention (CDC) published a 852-page review of PFAS health dangers, challenging the EPA’s determination of what the regulator considered safe levels for some of the compounds, finding that exposures could be a threat at many times lower than what the EPA had established.  

In October 2021, the EPA released what it described as a “strategic roadmap” aimed at restricting PFAS from being released into the environment. The plan also is supposed to accelerate the cleanup of existing PFAS contamination. The EPA said highlights of its plan include:

  • “Aggressive” timelines to set enforceable drinking water limits under the Safe Drinking Water Act “to ensure water is safe to drink in every community”.
  • Timelines for actions involved in the establishment of “effluent guideline limitations”, for nine industrial categories.
  • Establishment of a hazardous substance designation under the federal Superfund law that enhances the government’s ability to hold PFAS polluters financially accountable.
  • A review of past actions on PFAS taken under the Toxic Substances Control Act (TSCA) to address those that are insufficient. 
  • Increased monitoring, data collection and research so that the agency can identify what actions are needed and when to take them.
  • A final toxicity assessment for a type of PFAS called GenX used in manufacturing nonstick coatings that has been found in drinking water, rainwater and air samples.
  • Continued efforts to address PFAS emissions into the air.

The agency said it will also be increasing investments in research related to PFAS. U.S. President Joe Biden has called for more than $10 billion in funding to “monitor and remediate PFAS in drinking water” among other water system. 

The EPA has also been pursuing research into “PFAS destruction technology” and other possible mitigation measures amid mounting evidence of the pervasiveness of the PFAS compounds.

Politics

In November 2021 Michigan Democratic congresswoman Debbie Dingell introduced a bill in the U.S. House of Representatives proposing to ban PFAS in US food packaging and significantly reduce exposure to the highly toxic compounds. Similar legislation introduced in the last legislative session failed to pass.

PFAS manufacturers have actively lobbied against such laws on the chemicals. U.S. Sen. Jim Inhofe, who sits on the environmental committee and has opposed PFAS legislation, has received at least $60,000 from PFAS producers, according to The Guardian. 

State actions 

Many states have moved to investigate the extent of PFAS contamination, protect residents from PFAS exposures and to hold companies accountable for PFAS pollution. Here are a few recent actions:

Alabama – PFAS manufacturer 3M agreed to pay local government agencies in Alabama $98.4 million in October 2021 in a deal reached through court-ordered mediation over claims that one of the company’s chemical plants polluted the Tennessee River in northern Alabama. The money is to be used to fund cleanup efforts and reimburse water agencies prior efforts to remediate PFAS from the drinking water.  3M also agreed to pay $12 million to settle a potential class action lawsuit by Alabama drinking water customers. 

California – In October 2021, the state enacted new laws that prohibit the use of PFAS in children’s products; ban the sale or distribution of any food packaging that contains PFAS after Jan. 1, 2023; and order that by Jan.1, 2024, labels on cookware must list any PFAS in the product and provide a link or QR code to a webpage that contains more details.

Maine – Maine environmental regulators said in October 2021 that they were launching a statewide investigation to identify PFAS contamination sites related to the state’s municipal sludge and paper mills. State lawmakers have earmarked $30 million to test for PFAS and to install filtration systems on contaminated water systems. The state also said it will assist farmers whose land or water is found to have unsafe levels of PFAS. 

Michigan – In October 2021, Michigan Governor Gretchen Whitmer signed an executive directive telling the state to “use its purchasing power—an estimated $2.5 billion annually” to buy products that do not contain PFAS chemicals. 

New Hampshire – The New Hampshire Department of Natural Resources said in November 2021 that PFAS contamination was so high in five of its lakes that people should limit fish consumption, particularly children.  

North Carolina – In November 2021, North Carolina’s attorney general filed lawsuits against 14 manufacturers of a fire suppressant made with PFAS, asking the court to require the manufacturers to pay for investigations to determine the extent of the pollution damage and clean up the damage, replace water treatment systems and wells, and restore damaged natural resources, and monitor water quality going forward. The lawsuits focus on PFAS contamination at Charlotte-Douglas International Airport and at an Air National Guard Base.

Oregon – Oregon said in October 2021 it would test about 150 drinking water systems across the state to determine levels of PFAS contamination.  

Pennsylvania- Pennsylvania regulators in November 2021 said they would set enforceable limits on toxic “forever chemicals” in drinking water. Specifically, Pennsylvania officials said they plan to set drinking water limits on the two best-studied of the chemicals, known as PFOA and PFOS.

News & Opinion

Two ‘forever chemicals’ more toxic than previously thought: EPA drafts, by Rachel Frazen, The Hill, Nov. 16, 2021.

North Carolina AG sues 14 companies over fire suppressant, Associated Press, Nov. 5, 2021. “Attorney General Josh Stein filed four lawsuits which named 3M, Corteva, and DuPont, among others. In the lawsuit, Stein is asking the court to require the manufacturers to pay for investigations to determine the extent of the damage, clean up the damage, replace water treatment systems and wells, restore damaged natural resources and to monitor water quality.”

Senator, clean water advocates ask for state action after troubling GenX toxicity report, by Johanna Still, Port City Daily, Oct. 31, 2021. “Chemours’ trademark unregulated chemical GenX is more toxic than previously understood, according to a final toxicity report released by the Environmental Protection Agency Monday. The EPA’s new lifetime chronic reference dose for GenX, calculated with the most vulnerable populations in mind, is 3 parts per trillion (ppt). Concentrations of the chemical ingested over a lifetime at or below this threshold are unlikely to lead to negative health effects in humans, the report concludes.”

Forever chemicals widespread in Mass. Surface and ground water, says new report, by Barbara Moran, WBUR, Oct. 29, 2021. “The new analysis of state data follows reports of PFAS contamination in Cape Cod ponds and many Massachusetts rivers, pointing to widespread contamination throughout state lakes, ponds, rivers and aquifers used as sources for drinking water.”

EPA finds chemical contaminating NC river more toxic than previously assessed, by Rachel Frazin, The Hill, Oct. 25, 2021.

Lethal ‘forever chemical’ taint our food, water and even blood. The EPA is stalling, by David Bond, The Guardian, Oct. 24, 2021. “There is no longer any population or place on earth untouched by PFAS contamination. We are living through a toxic experiment with no control group.”

How chemical companies avoid paying for pollution, by David Gelles and Emily Steel, The New York Times, Oct. 20, 2021. “To avoid responsibility for what many experts believe is a public health crisis, leading chemical companies like Chemours, DuPont and 3M have deployed a potent mix of tactics. They have used public charm offensives to persuade regulators and lawmakers to back off. They have engineered complex corporate transactions to shield themselves from legal liability. And they have rolled out a conveyor belt of scantly tested substitute chemicals that sometimes turn out to be just as dangerous as their predecessors.”

Bad Chemistry series of articles by Sharon Lerner, The Intercept, September 2015-ongoing. “The U.S. has refused to regulate the chemicals in this class, known as PFAS, despite the fact that they persist indefinitely in the environment and have been linked to cancer and many other illnesses.” 

EPA unveils new strategy to address US contamination of ‘forever’ chemicals, by Carey Gillam, The Guardian, Oct. 18, 2021. “The US Environmental Protection Agency (EPA) on Monday announced a “strategic roadmap” it said would help restrict a class of toxic chemicals from being released into the environment and accelerate the cleanup of existing contamination of “forever chemicals” that are associated with a range of human health dangers.”

Revealed: More than 120,000 US sites feared to handle harmful PFAS ‘forever’ chemicals, by Carey Gillam, The Guardian, Oct. 17, 2021 “The US Environmental Protection Agency (EPA) has identified more than 120,000 locations around the US where people may be exposed to a class of toxic “forever chemicals” associated with various cancers and other health problems that is a frightening tally four times larger than previously reported, according to data obtained by the Guardian.”

Suppressed Study: The EPA underestimated dangers of widespread chemicals, by Abrahm Lustgarten, ProPublica, , June 20, 2018. “A major environmental health study that had been suppressed by the Trump administration because of the “public relations nightmare” it might cause the Pentagon and other polluters has been quietly released online.”

The lawyer who became DuPont’s worst nightmare, by Nathaniel Rich, The New York Times, Jan. 6, 2016. “Rob Bilott was a corporate defense attorney for eight years. Then he took on an environmental suit that would upend his entire career — and expose a brazen, decades-long history of chemical pollution.”

The Teflon toxin, three-part series of articles by Sharon Lerner, The Intercept, Aug. 11, 2015 – Aug. 20, 2015. “In this series, Sharon Lerner exposes DuPont’s multi-decade cover-up of the severe harms to health associated with a chemical known as PFOA, or C8, and associated compounds such as PFOS and GenX.”

The Teflon toxin goes to court, by Sharon Lerner, The Intercept, Sept. 19, 2015. “DuPont went to court this week, defending its use of C8, the chemical that spread from the company’s Parkersburg, West Virginia, plant into the drinking water of some 80,000 people in West Virginia and Ohio. A jury in Columbus, Ohio, is now hearing the case of Carla Bartlett, a 59-year-old woman who developed kidney cancer after drinking C8-contaminated water for more than a decade.” 

Papers: DuPont hid chemical risk studies, by John Heilprin, Associated Press, Nov. 16, 2005. “DuPont Co. hid studies showing the risks of a Teflon-related chemical used to line candy wrappers, pizza boxes, microwave popcorn bags and hundreds of other food containers, according to internal company documents and a former employee.”

Statements

Zürich Statement on Future Actions on Per- and Polyfluoroalkyl Substances (PFASs), Environmental Health Perspectives, August 2018. 

Comment on “Fluorotechnology Is Critical to Modern Life: The FluoroCouncil Counterpoint to the Madrid Statement,” Environmental Health Perspectives July 2015. 

The Madrid Statement on Poly- and Perfluoroalkyl Substances (PFASs), Environmental Health Perspectives, May 2015. 

Helsingør statement on poly- and perfluorinated alkyl substances (PFASs), Chemosphere, November 2014. 

Research 

Birth Defects 

Perfluorooctanoate Exposure and Major Birth Defects, Reproductive Toxicology, August 2014.  

Cancer

Per- and Polyfluoroalkyl Substance Exposure Combined with High-Fat Diet Supports Prostate Cancer Progression, Nutrients, September, 2021.

Perfluorooctanoic Acid (PFOA) Exposures and Incident Cancers Among Adults Living Near a Chemical Plant, Environmental Health Perspectives, November 2013.  

Perfluorooctanoic acid exposure and cancer outcomes in a contaminated community: a geographic analysis, Environmental Health Perspectives, March 2013  

Cholesterol 

Modeled PFOA exposure and coronary artery disease, hypertension, and high cholesterol in community and worker cohorts, Environmental Health Perspectives, December 2014.  

Associations between PFOA, PFOS and changes in the expression of genes involved in cholesterol metabolism in humans, Environment International, July 2013. 

Diabetes

Incidence of type II diabetes in a cohort with substantial exposure to perfluorooctanoic acid, Environmental Research, January 2014. 

Hormones 

Perfluoroalkyl Substances, Sex Hormones, and Insulin-like Growth Factor-1 at 6-9 Years of   Age: A Cross-Sectional Analysis within the C8 Health Project. Environmental Health     Perspectives, August 2016.

PFOA and PFOS are associated with reduced expression of the parathyroid hormone 2 receptor (PTH2R) gene in women, Chemosphere, February 2015. 

Hyperactivity

Serum Perfluorinated Compound Concentration and Attention Deficit/Hyperactivity Disorder in Children 5-18 Years of Age, Environmental Health Perspectives, October 2011.  

Inflammatory bowel disease

Inflammatory bowel disease and biomarkers of gut inflammation and permeability in a community with high exposure to perfluoroalkyl substances through drinking water, Environmental Research, 2019 November 2019. 

Kidney Function

Perfluorooctanoic acid and chronic kidney disease: Longitudinal analysis of a Mid-Ohio Valley community, Environmental Research, April 2016. 

Exposure to perfluoroalkyl acids and markers of kidney function among children and adolescents living near a chemical plant, Environmental Health Perspectives, May 2013.

Liver Function

Modeled Perfluorooctanoic Acid (PFOA) Exposure and Liver Function in a Mid-Ohio Valley Community, Environmental Health Perspectives, August 2016. 

Neuropsychological Outcomes

Perfluorooctanoate and neuropsychological outcomes in children, Epidemiology, July 2013.

Obesity

Early life perfluorooctanoic acid (PFOA) exposure and overweight and obesity risk in adulthood in a community with elevated exposure, Environmental Research, July 2014. 

Pregnancy

Impact of exposure uncertainty on the association between perfluorooctanoate and preeclampsia in the C8 Health Project population, Environmental Health Perspectives, January 2016.

Perfluorooctanoic Acid exposure and pregnancy outcome in a highly exposed community, Epidemiology, May 2012.  

Relationship of Perfluorooctanoic Acid Exposure to Pregnancy Outcome Based on Birth Records in the Mid-Ohio Valley, Environmental Health Perspectives, March 2012.  

Serum Perfluorooctanoic Acid and Perfluorooctane Sulfonate Concentrations in Relation to Birth Outcomes in the Mid-Ohio Valley, 2005-2010, Environmental Health Perspectives, October 2013 

PFOA and PFOS serum levels and miscarriage risk, Epidemiology, July 2014. 

Puberty

Association of perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) with age of puberty among children living near a chemical plant, Environment Science & Technology, October 2011.  

Thyroid

High exposure to perfluorinated compounds in drinking water and thyroid disease. A cohort study from Ronneby, Sweden. Environmental Research, September 2019. 

Exposure to perfluoroalkyl substances and thyroid function in pregnant women and children: A    systematic review of epidemiologic studies, Environment International, February 2017. 

Perfluorooctanoic acid exposure and thyroid disease in community and worker cohorts, Epidemiology, March 2014.    

Thyroid Function and Perfluoroalkyl Acids in Children Living Near a Chemical Plant, Environmental Health Perspectives, March 2012.

Ulcerative colitis

PFOA and ulcerative colitis, Environmental Research, May 2018. 

Ulcerative colitis and perfluorooctanoic acid (PFOA) in a highly exposed population of community residents and workers in the Mid-Ohio Valley, Environmental Health Perspectives, August 2013.  

Exposure, water contamination issues, general

Evaluation and management strategies for per- and polyfluoroalkyl substances (PFASs) in drinking water aquifers: perspectives from impacted U.S. northeast communities, Environmental Health Perspectives, June 2018. 

Half-lives of PFOS, PFHxS and PFOA after end of exposure to contaminated drinking water, Occupational and Environmental Medicine, November 2017.  

Technical Report: Half-lives of PFOS, PFHxS and PFOA after end of exposure to       contaminated drinking water, The Sahlgrenska Academy Institute Of Medicine, University of      Gothenburg, 2017.

A cohort incidence study of workers exposed to perfluorooctanoic acid (PFOA), Occupational Environmental Medicine, May 2015. 

Associations Between Serum Perfluoroalkyl Acids and LINE-1 DNA Methylation, Environment International, February 2014. 

Cohort mortality study of workers exposed to perfluorooctanoic acid, American Journal of Epidemiology, November 2012.    

Environmental fate and transport modeling for perfluorooctanoic acid emitted from the Washington Works Facility in West Virginia, Environment Science & Technology, January 2011. 

Private drinking water wells as a source of exposure to PFOA in communities surrounding a fluoropolymer production facility, Environmental Health Perspectives, January 2011. 

Biomarker-based calibration of retrospective exposure predictions of perfluorooctanoic acid, Environmental Science & Technology, May 2014. 

Accumulation and clearance of PFOA in current and former residents of an exposed community, Environmental Health Perspectives, January 2011.    

Epidemiologic evidence on the health effects of perfluorooctanoic acid (PFOA), Environmental Health Perspectives, August 2010. 

The C8 Health Project: Design, methods, and participants, Environmental Health Perspectives, December 2009. 

Other fact sheets and resources

Interstate Technology and Regulatory Council

Agency for Toxic Substances and Disease Registry

National Institute of Environmental Health Sciences

Centers for Disease Control and Prevention 

Environmental Working Group

Great Lakes PFAS Policy Agenda.

Center for the Advancement of Public Action (CAPA) at Bennington College

Books and film

Exposure – Poisoned Water, Corporate Greed, and One Lawyer’s Twenty-Year Battle against DuPont, by Robert Bilott, Atria Books (July 14, 2020).

The Devil We Know documentary film

Dark Waters feature film

California court rejects Bayer’s petition to review Pilliod Roundup trial victory

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Bayer AG suffered yet another setback this week in the company’s ongoing effort to undo at least one of the trial losses dealt to Monsanto Co. in U.S. litigation alleging that the company’s Roundup herbicide causes cancer and Monsanto spent decades covering up the risks.

Bayer, which bought Monsanto in 2018 just as the first Roundup trial was getting underway, petitioned the California Supreme Court in September seeking a review of the case of Pilliod v. Monsanto.  The court rejected that petition for review on Wednesday.

Husband and wife Alva and Alberta Pilliod were awarded over $2 billion in 2019 after a trial in which their lawyers presented evidence that the non-Hodgkin lymphoma (NHL) suffered by both was caused by their long-term exposure to Roundup herbicide. Alberta was diagnosed with non-Hodgkin lymphoma brain cancer  in 2015, while her husband Alva was diagnosed in 2011 with non-Hodgkin lymphoma that spread from his bones to his pelvis and spine. The couple had started using Roundup in the 1970s and used it for more than 30 years.

The trial judge then lowered the jury award to $87 million.

Alberta Pilliod told US Right to Know that she and her husband were very happy to hear of the court’s rejection of Bayer’s petition, and hope to soon see their judgment paid.

“We’ve jumped through all the hoops. We’d like to get to the final score,” she said.

Alva Pilliod, 79, remains in remission, and though 77-year-old Alberta is also currently in remission she has had multiple recurrences of her cancer and has to be hospitalized frequently for health problems, she said.

The California Supreme  Court’s refusal to review the Pilliod case comes three months after the 1st Appellate District in the Court of Appeal for California rejected Monsanto’s bid to overturn the trial loss.

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

The court also said there was substantial evidence that Monsanto acted with a “willful and conscious disregard for the safety of others,” supporting the awarding of punitive damages.

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

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

Damning evidence

Evidence laid out in the Pilliod trial and two previous trials included numerous scientific studies that showed what plaintiffs’ attorneys said was proof Monsanto’s herbicides cause NHL. As well, the attorneys presented jurors with many internal Monsanto communications obtained through court-ordered discovery that show Monsanto has intentionally manipulated the public record to hide the cancer risks.

Bayer has settled several other cases that were scheduled to go to trial over the last two years. And in 2020, the company said it would pay roughly $11 billion to settle about 100,000 existing Roundup cancer claims. This year, 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.

Stephens trial drags on

Even as Bayer attempts to settle cases, it also is proceeding to trial with several. One trial that has turned into a sluggish, on-again-off-again, Zoom-based trial is the case of Donnetta Stephens v. Monsanto.

The case, in the Superior Court of San Bernardino County in California, has been held via Zoom due to concerns about the spread of Covid-19, but has been marred by numerous technical problems as well as scheduling conflicts.

The jury trial has generally only been in session 2-3 days per week after getting underway in July. The next session is set for Monday, which will be the 51st day of trial.

Stephens suffers from non-Hodgkin lymphoma she blames on her use of Roundup. Her 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 due.

Paraquat Papers – Updates to U.S. litigation

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Multiple lawsuits are pending in the United States against Syngenta alleging the weedkilling chemical paraquat causes Parkinson’s disease.

A notice of settlement was filed June 18, 2021 for several paraquat cases. See this document.

But more than 400 lawsuits are pending.

The lawsuits name Syngenta as well as Chevron Phillips Chemical Co. and Growmark Inc. as defendants. Chevron distributed and sold Gramoxone paraquat product in the United States in an agreement with a Syngenta predecessor called Imperial Chemical Industries (ICI), which introduced paraquat-based Gramoxone in 1962. Under a license agreement, Chevron had the right to to manufacture, use, and sell paraquat formulations in the U.S.

Lawyers around the United States are advertising for plaintiffs, seeking to draw in thousands of people who’ve been exposed to paraquat and now suffer from Parkinson’s.

Here is a list of actions pending through Judicial Council Coordination Proceedings (JCCP) as of Aug. 2, 2021

  • Harker v. Syngenta, et al. Case No. CGC-21-589755 (San Francisco Superior Court) (coordinated June 11, 2021)
  • De La Vega v. Syngenta, et al. Case No. C21-01057. (Contra Costa Superior Court) (coordinated July 19, 2021)
  • Louis Lombardo v. Syngenta et al., Alameda County Superior Court; Case No. RG21100757, filed on May 26, 2021 (coordinated July 19, 2021)
  • Lonnie Owens et al. v. Syngenta et al., Contra Costa Superior Court; Case No. C21-01187, filed on June 4, 2021 (coordinated July 19, 2021)
  • Borrelli v. Syngenta AG, et al. (Case No. MSC21-01217), filed June 24, 2021 in Contra Costa County Superior Court (coordinated July 23, 2021)
  • Isaak v. Syngenta AG, et al., San Francisco Superior Court; Case No. CGC-21591254 (coordinated August 2, 2021)
  • Rubino v. Syngenta, et al., Contra Costa County Superior Court Case No. C2101422 (coordinated August 2, 2021)
  • Aguiar v. Syngenta, et al. Case No. C21-01373. (Contra Costa Superior Court) (coordinated August 2, 2021)

Multidistrict litigation

On April 7, 2021, the Fears Nachawati Texas-based law firm filed a motion with the U.S. Judicial Panel on Multidistrict Litigation in Washington, D.C., asking that pending paraquat lawsuits be consolidated for pretrial proceedings in the Northern District of California, the same federal court where Roundup litigation was consolidated. The case with the judicial panel is MDL No. 3004. The panel hearing on the matter was May 27 and on June 7, the panel approved the formation of the paraquat multidistrict litigation, assigning it to Judge  Nancy J. Rosenstengel in the Southern District of Illinois.

Additionally, a class action lawsuit was filed in federal court in Iowa on May 3. The suit seeks “equitable relief in the form of medical monitoring, including, but not limited to, the costs of diagnostic testing” for farmers and others exposed to paraquat who are allegedly at “increased risk” for Parkinson’s, according to the legal filing.

At least 87 lawsuits were pending within the MDL as of October 25, 2021.

Science

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.”

A more 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.”

Parkinson’s is an incurable progressive nervous system disorder that limits a person’s ability to control movement, causing tremors, loss of balance and eventually often leaving victims bedridden and/or bound to a wheelchair. The disease is not necessarily fatal but typically becomes severely debilitating.

Dutch neurologist Bastiaan Bloem, who recently authored a book about Parkinson’s, blames widespread exposure to herbicides such as paraquat, along with other toxic chemicals used in agriculture and manufacturing, for the spread of the disease.

Acutely Toxic 

Along with fears about links between paraquat and Parkinson’s, paraquat is also known to be an extremely acutely toxic chemical that can quickly kill people who ingest very small amounts. In Europe, the sale of paraquat has been banned since 2007, but in the United States the pesticide is sold as a “Restricted Use Pesticide” due to “acute toxicity.”

As part of discovery in the Parkinson’s litigation, lawyers have obtained internal records from Syngenta and its predecessor corporate entities dating back to the 1960s. Many of these documents are sealed, but some have started to come to light.

Those unsealed discovery documents, which include copies of letters, minutes of meetings, study summaries, and emails, are being made available on this page.

Most of the documents unsealed to date deal with corporate discussions about how to keep paraquat herbicides on the market despite its deadliness, through measures designed to reduce accidental poisonings. Specifically, many of the documents detail an internal corporate struggle over the addition of an emetic, a vomit-inducing agent, to paraquat products.  Today, all Syngenta paraquat-containing products include an emetic called “PP796.”  Liquid paraquat-containing formulations from Syngenta also include a stenching agent to produce a foul odor, and a blue dye to differentiate the dark-colored herbicide from tea or cola or other beverages.

EPA Review 

Paraquat recently underwent the EPA’s registration review process,  and on August 2, 2021 the agency said paraquat would remain on the market with new safety measures aimed at reducing farmworker exposures. That followed the Oct. 23, 2020 release of a proposed interim decision (PID) for paraquat.  The interim decision proposed mitigation measures to reduce human health and ecological risks identified in the agency’s 2019 draft human health and ecological risk assessments.

Several organizations in September 2021 petitioned the 9th U.S. Circuit Court of Appeals, asking for the court to review and set aside the EPA’s decision. The petitioners include the California Rural Legal Assistance Foundation, Farmworker Association of Florida, Michael J. Fox Foundation for Parkinson’s Research, Farmworker Justice, Alianza Nacional de Campesinas, Pesticide Action Network North America, Center for Biological Diversity, and Toxic Free North Carolina. The groups claim the EPA is violating the Federal Insecticide, Fungicide, and Rodenticide Act

The EPA had indicated it would likely ban most aerial spraying of paraquat, but after industry lobbying efforts, the agency said it would allow such use with restrictions around residential areas.

The EPA said that through collaboration with the National Toxicology Program at the National Institute of Environmental Health Sciences, the agency completed a “thorough review” of the scientific information on paraquat and Parkinson’s Disease and concluded that the weight of evidence was insufficient to link paraquat to Parkinson’s disease. The agency published this “Systematic Review of the Literature to Evaluate the Relationship between Paraquat Dichloride Exposure and Parkinson’s Disease.”

In finding no evidence of a connection between paraquat and Parkinson’s, the EPA relied in part on input from the Agricultural Handler Exposure Task Force (AHETF),  a group that includes large agrochemical companies such as Syngenta AG, Bayer, Dow/Corteva, and others.

USRTK will add documents to this page as they become available.

Litigation alleging Syngenta’s paraquat weed killer causes Parkinson’s disease moving toward trial

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Lawyers involved in U.S. litigation accusing Syngenta AG of spending decades selling an herbicide that causes Parkinson’s disease are moving toward selection of a bellwether trial to be held roughly a year from now, according to the federal judge overseeing the litigation.

In a hearing on Friday, U.S. District Judge Nancy Rosenstengel of the Southern District of Illinois told lawyers for the hundreds of plaintiffs so far involved in the cases against Syngenta that they should work quickly to have the plaintiffs complete assessment questionnaires and provide their medical records and other relevant documents.

She said lawyers should be planning for a trial this time next year, though it is not clear yet who the first plaintiff or group of plaintiffs will be.

Rosenstengel is overseeing what is known as “multidistrict litigation (MDL) as a means of  consolidating the pretrial proceedings, such as discovery of evidence and depositions of witnesses. There are currently more than 380 cases within the MDL.

The judge also advised lawyers for plaintiffs and the defendants to work to coordinate with lawsuits in state courts that are making the same allegations – that exposure to paraquat weed killer caused the plaintiffs to develop Parkinson’s disease, a devastating neurological disease. Cases are pending in California, Illinois, Pennsylvania, and Washington.

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

On Friday, lawyers for Chevron USA Inc. filed a stipulation with the court stating that they had reached an agreement with plaintiffs’ co‐lead counsel allowing for the dismissal of Chevron USA and other entities from the litigation.

The stipulation states that Chevron Chemical Company (whose liabilities Chevron U.S.A. Inc.
assumed) stopped distributing paraquat in 1986 and transferred all paraquat registrations held by Chevron to a non‐Chevron entity at that time.

Lawyers around the United States are advertising for plaintiffs, seeking to draw in thousands of people who’ve been exposed to paraquat and now suffer from Parkinson’s.

The lawsuits include allegations “that manufacturers and sellers of paraquat deliberately concealed the dangers of paraquat for at least four decades, hid evidence of its dangers from government safety agencies, and knowingly unleased a product they knew caused Parkinson’s Disease on the public.”

On Oct. 27, Judge Rosenstengel issued an order regarding the “preservation and production”  of documents and other information. The defendants had already turned over a large amount of internal documents and other materials in a lawsuit that they settled earlier this year. Those materials are to be provided to the plaintiffs’ attorneys in the MDL action.

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.”

Lawyers for plaintiff George Isaak sought the judge’s permission to grant Isaak an expedited trial early in 2022 but were rejected.

Stephens trial drags on, toxicologist testifies about studies of herbicide and cancer risk

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A scientist testified Monday that a California woman’s regular use of Monsanto’s Roundup herbicide “vastly” exceeded the exposure scientific research shows more than doubles the risk of developing non-Hodgkin lymphoma (NHL).

William Sawyer, a toxicologist and expert witness for plaintiff Donnetta Stephens in her lawsuit against Monsanto, cited scientific research that links use of Monsanto’s glyphosate-based herbicides, including Roundup, to cancer and specifically to NHL.  Sawyer has testified in prior Roundup cancer trials, including a 2019 trial that resulted in a jury verdict of more than $2 billion for a husband-and-wife who both suffered from NHL.

The Stephens v. Monsanto trial has been underway for roughly three months, starting in late July. The proceedings have been  handled via Zoom, and multiple technical problems have at time hindered the delivery of testimony and sharing of evidence with jury members.

Jurors have heard from Stephens, her son, various cancer  experts and from some of Monsanto’s top scientists, including longtime Monsanto toxicologist Donna Farmer. Farmer now works for Bayer AG, the German pharmaceutical company that bought Monsanto in 2018.

“Perpetual” pain

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. 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.

Juries in the first three 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.

Monsanto won a recent trial involving a mother who claimed her son developed NHL because of exposure he experienced while she sprayed the weed killer.

More trouble for Bayer

Angry investors can proceed with litigation against Bayer over allegations that the company made misleading statements about its $63 billion 2018 acquisition of Monsanto, and of the extent of concerns about the company’s herbicide products.

A federal judge ruled last week that a class action led by a group of pension funds can proceed with their claims that Bayer proceeded with its purchase of Monsanto despite analyst warnings and an awareness that acquiring Monsanto brought significant risks, and assuring investors Bayer management had fully assessed those risks.

Bayer has settled several cases that were scheduled to go to trial over the last two years. And in 2020, the company said it would pay roughly $11 billion to settle a majority of the more than 100,000 existing Roundup cancer claims. The company recently said it was setting aside another $4.5 billion toward Roundup litigation liability.

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

Bayer wins Roundup trial; plaintiff fails to prove exposure caused child’s disease

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The former Monsanto Co., now owned by Bayer AG, notched its first win in the mass tort U.S. Roundup litigation on Tuesday, defeating at trial a mother who alleged her use of Roundup exposed her child to the pesticide and caused him to develop cancer.

Ezra Clark was born in May 2011 and diagnosed in 2016 with Burkitt’s lymphoma, a form of non-Hodgkin lymphoma (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, which was heard in Los Angeles County Superior Court. A different Roundup trial is underway in San Bernardino 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 has autism and his mother said it calmed him to play outdoors while she worked in the yard, which meant he often played in areas freshly sprayed with Roundup, according to the court filings.

Fletch Trammell, lead attorney for Clark, said his case was subject to a bifurcation order that organized the case into two phases. In the first phase he was limited to presenting evidence that focused on the child’s personal exposure to Roundup and whether or not it could have been enough to have contributed to his disease. The case would have proceeded to a second phase had the plaintiff won the first phase, but the loss in the first phases ends the trial.

“This was nothing like any of the other three trials,” Trammell said.

The jury was asked to address one key question in the first phase: Whether or not the child’s exposure to  Roundup was a “substantial factor” in his development of Burkitt’s lymphoma.

In a 9 to 3 decision, the jury found that it was not.

Trammell said the jury decision was because the jury doubted the child’s exposure to Roundup could have been enough to cause cancer. The decision did not address the larger question of the alleged carcinogenicity of Roundup overall, he said.

But Bayer, which bought Monsanto in 2018 as the first Roundup trial was getting underway, said the jury’s decision was in line with scientific research showing glyphosate, the main ingredient in Roundup, is safe and does not cause cancer.

“The jury carefully considered the science applicable to this case and determined that Roundup was not the cause of his illness,” the company said in a statement.

80 hours

During the trial, Trammel presented evidence indicating Ezra was exposed to Roundup for about 80 cumulative hours over the years his mother sprayed with him at her side. He paired that with research showing there could ben an increased risk of NHL associated with repeated spraying of glyphosate herbicides, such as Roundup. And he noted language on Roundup labels in Canada that advise users to wear protective gloves and avoid getting the chemical on bare skin.

“The studies… they show that Roundup does three different things when it gets to your
lymphocyte cells…   It can kill cells, which is bad enough; but it also causes the exact DNA damage
that results in Burkitt’s lymphoma; it also, in a variety of ways, devastates your body’s ability to
repair DNA damage,” Trammell told jurors in his closing argument.

Trammell also sought to counter problems with deposition testimony given by Destiny Clark. Trammell said the mother also has suffered from cancer, a cervical cancer that metastasized to her brain. The illness and treatments she has undergone made it difficult for her to recall details and she “made a lot of mistakes” in the deposition she gave to Monsanto’s attorneys, Trammell told jurors. But she was very clear, he told jurors, on recalling her use of Roundup nearly “every weekend” when Ezra was young.

Monsanto attorney  Brian Stekloff told jurors that Ezra’s exposure was in doubt. He told jurors that while they might have sympathy for the family, they could not ignore inconsistencies in Destiny Clark’s testimony about how often her son was exposed, and could not ignore statements by other family members that they did not see her spraying around Ezra.

“And there is an old adage or old saying, and it goes like this: The truth is simple because there’s nothing to remember,” Stekloff told jurors. “When you tell the truth, you don’t mix up the facts. It’s when it didn’t happen that you can’t remember what you said the first time and the next time, and the next time, and the next time. And the inconsistencies start piling up and piling up, and the explanations start coming and piling up and piling up. And that’s what you have seen here in this trial.”

Stekloff told jurors the evidence did not support a finding that exposure to Roundup was a substantial factor in causing his cancer.

“This is not a popularity contest. This is not a referendum on Monsanto. It’s not even a referendum on Roundup,” he said in his closing argument. “Roundup did not cause Ezra Clark’s Burkitt’s lymphoma.”

Clark is one of tens of thousands of plaintiffs who filed U.S. lawsuits against Monsanto after the World Health Organization’s cancer experts in 2015 classified glyphosate – the active ingredient in Monsanto’s herbicides – as a probable human carcinogen with an association to NHL.

Monsanto lost each of the three previous trials, after lawyers for the plaintiffs presented jurors with multiple scientific studies finding potential health risks with glyphosate and Roundup  The plaintiffs lawyers also used internal Monsanto documents as evidence, arguing the so-called “Monsanto Papers” showed intentional efforts by the company to manipulate regulators and control scientific research.

The jury in the last trial ordered $2 billion in damages though the award was later shaved to $87 million.

Bayer has maintained that there is no cancer risk with the glyphosate herbicides it inherited from Monsanto, but it has agreed to pay close to $14 billion to try to settle the litigation and said it will remove glyphosate products from the U.S. consumer market by 2023. The company will continue to sell the herbicides to farmers and other commercial users.

Mike Miller, who heads the Virginia law firm that won two of the three previously held Roundup trials, i but who was not involved in the Clark case, said the verdict does not change anything about the litigation, nor Bayer’s liability.

“Nothing about that verdict change the fact: Roundup causes cancer,” he said.

See transcript of closing arguments in Clark v. Monsanto. 

Monsanto scientist tells jurors company’s side of Roundup cancer controversy

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A senior scientist at the former Monsanto Co. on Tuesday told jurors in a California trial that regulators around the world support the company’s position that its glyphosate-based herbicides, such as the popular Roundup brand, are safe for users.

Donna Farmer, who worked as a toxicologist at Monsanto for more than two decades and now works at Monsanto owner Bayer AG, spent long hours testifying in the case of Donnetta Stephens v. Monsanto. Farmer has been a key witness in the Stephens case and was quizzed intently for days by lawyers for Stephens before Monsanto’s lawyers took up the questioning.

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

The Stephens case is the fourth Roundup cancer lawsuit to go to trial and the first since 2019. Stephens suffers from non-Hodgkin lymphoma she blames on her use of Roundup herbicide for more than 30 years.

A chance to explain

Monsanto lawyer Monsanto lawyer Manuel Cachan questioned Farmer about several issues that were raised earlier by plaintiffs’ attorneys, telling Farmer it was her chance to explain details about several matters that Stephens’ lawyers had presented as evidence of Monsanto wrong-doing.

One such issue involved comments Farmer wrote in a 2003 email to colleagues about the importance of distinguishing between the chemical glyphosate and the Roundup formulation, which is made with glyphosate as the active ingredient.

In the email, Farmer wrote “The terms glyphosate and Roundup cannot be used interchangeably nor can you use “Roundup” for all glyphosate-based herbicides any more. For example you cannot say that Roundup is not a carcinogen… we have not done the necessary testing on the formulation to make that statement. The testing on the formulations are not anywhere near the level of the active ingredient.”

Plaintiffs’ lawyers have pointed to that language as part of a broad argument disputing Monsanto’s contention that thorough testing of Roundup has demonstrated it does not cause cancer.

In testimony Tuesday, Farmer said that she merely was trying to be “very precise” when explaining to colleagues the distinctions between products. She was not indicating in the email that there was any question about whether or not Roundup might cause cancer, Farmer testified.

She pointed out that in that internal email she also wrote “there is no reason to believe that Roundup would cause cancer.”

And though it was true at that time that Monsanto had not conducted extensive carcinogenicity testing on Roundup formulations, that changed over time, Farmer testified.

“I think we’ve got a lot more studies on Roundup than we had, and so I think we have a lot more information about the Roundup formulations that still supports the conclusions and safety about the formulation,” Farmer told the jury.

A regulatory pass

At another point in the questioning by Monsanto’s lawyer, Farmer told jurors that regulators had never required the company to conduct animal carcinogenicity testing on Roundup. She said not only had the U.S. EPA not demanded such testing, but regulators in Canada, Europe, Australia and Japan had similarly not required any such animal testing on Roundup products.

She also told jurors that while it was true that Roundup products contain formaldehyde, it was a “very, very small amount” and posed no danger to human health. Regulators agreed there was no reason for concern, Farmer testified.

“We produce formaldehyde every day in our bodies,” said Farmer. “Small amounts of formaldehyde like in the formulations at those low levels do not present a health hazard to humans.”

Farmer’s testimony sought to rebut other points of evidence raised by Stephens’ lawyers, seeking to cast Monsanto as a responsible, science-based organization that has been the innocent target of activist-driven misinformation. Plaintiffs’ lawyers have twisted internal conversations seen in emails and other communications to confuse and mislead jurors, according to arguments by Monsanto attorneys.

Monsanto lost each of the three previous trials, after lawyers for the plaintiffs presented jurors with multiple scientific studies finding potential health risks with glyphosate and Roundup  The plaintiffs lawyers also used internal Monsanto documents as evidence, arguing they showed intentional efforts by the company to manipulate regulators and control scientific research.

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. Bayer also recently said it would set aside another $4.5 billion toward Roundup litigation liability.

To try to quell future litigation, Bayer said 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.

EPA exposed for hiding chemical risks, favoring corporate interests

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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.

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Background: 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.

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:

New evidence of corruption at EPA chemicals division, by Sharon Lerner, The Intercept, September 18, 2021

EPA whistleblower testifies her advocacy for stronger health protections drew agency retaliation, by Carey Gillam, USRTK, September 13, 2021

‘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.

Monsanto scientist defends Roundup safety in California trial

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A senior scientist at the former Monsanto Co. told jurors in a California trial that the company’s Roundup herbicide is so safe that the scientist uses it regularly at her home, and suggests friends also use the weed killing product.

Donna Farmer, who worked as a toxicologist at Monsanto for more than two decades and now works at Monsanto owner Bayer AG, spent long hours testifying Monday and on multiple days last week in the case of Donnetta Stephens v. Monsanto. The Stephens case is the fourth Roundup cancer lawsuit to go to trial and the first since 2019. Stephens suffers from non-Hodgkin lymphoma she blames on her use of Roundup herbicide for more than 30 years.

Stephens is one of tens of thousands of plaintiffs who filed U.S. lawsuits against Monsanto after the World Health Organization’s cancer experts in 2015 classified glyphosate – the active ingredient in Monsanto’s herbicides – as a probable human carcinogen with an association to non-Hodgkin lymphoma.

Monsanto lost each of the three previous trials, after lawyers for the plaintiffs presented jurors with multiple scientific studies finding potential health risks with glyphosate and Roundup  The plaintiffs lawyers also used internal Monsanto documents as evidence, arguing the so-called “Monsanto Papers” showed intentional efforts by the company to manipulate regulators and control scientific research.

The jury in the last trial ordered $2 billion in damages though the award was later shaved to $87 million.

Bayer, which bought Monsanto in 2018, insists there is no cancer risk with its glyphosate herbicides, but it has agreed to pay close to $14 billion to try to settle the litigation and said it will remove glyphosate products from the U.S. consumer market by 2023. The company will continue to sell the herbicides to farmers and other commercial users.

Combative exchanges

In testimony delivered under cross-examination by Stephens’ lawyer William Shapiro, Farmer was combative, going beyond answering the yes or no questions Shapiro posed to her in an effort to “explain” the context she said Shapiro was misrepresenting.

Shapiro quizzed Farmer about emails and documents dating back to the late 1990s that Shapiro presented as evidence that Farmer and other company scientists engaged in misconduct, including ghostwriting scientific papers to fraudulently assert the safety of its glyphosate-based herbicides and buried information that found cancer risk with the products.

On Monday, Monsanto lawyer Manuel Cachan questioned Farmer about many of the same pieces of evidence focused on by Shapiro, but cast the emails and other evidence as innocent exchanges that bear no signs of deceit or misconduct.

Under Cachan’s questioning, Farmer said that based on the science that she is familiar with, she does not believe glyphosate causes cancer, and is confident that Roundup is safe to use. She said that she is so certain of the safety of Roundup that she has used it around her yard for about 25 years. She does not wear gloves or special protective gear when spraying, she testified. Farmer said she has no worries about recommending the product to family members and friends.

Farmer said the phase-out for consumers is not due to any safety concerns and is being removed from consumer markets simply “because of the litigation and the lawsuits.” Farmer said she does not think the product should be withdrawn.

“The product is in my opinion – and not just my opinion but regulators around the world – the product is safe and is not a carcinogen,” Farmer testified.

Even after Bayer stops selling Roundup to consumers in 2023, Farmer said she plans to keep using it.

“It has a good shelf life so I’ll probably buy some extra bottles,” she said. “You can go to dealerships in farm country, you can buy some of the products there.”

Monsanto has been persecuted by an anti-pesticide movement, according to Farmer.

“There are a lot of people who don’t like pesticides. They don’t like glyphosate and quite frankly don’t like Monsanto. There are a lot of people who make allegations and spread misinformation about the safety of our products,” Farmer testified.

Beyond Pesticides

At one point in her testimony, Farmer weighed in on a nonprofit group and Monsanto critic called Beyond Pesticides, telling jurors that Beyond Pesticides was not a scientific group but rather an activist group that was “misrepresenting the science” about synthetic pesticides such as glyphosate.

“Their mission is to stop the use of synthetic pesticides and so what they publish is misinformation, inaccurate information about pesticides,” she testified.

Monsanto’s lawyer asked her to address a 2008 internal Monsanto email regarding a press release issued by Beyond Pesticides. The press release by the nonprofit group shared a research study that found glyphosate exposure could increase a person’s risk of developing non-Hodgkin lymphoma. The group advised people should embrace organic agriculture and use “non-toxic land care” on residential lawns.

In the email, Farmer had written to colleagues: “We have been aware of this paper for awhile and knew it would only be a matter of time before the activists picked it up.” Mentioning the Beyond Pesticides line about embracing organic agriculture, Farmer had written: How do we combat this?”

Under questioning from Monsanto’s lawyer, Farmer explained that she was not indicating Monsanto should try to combat the scientific research but was addressing only the Beyond Pesticide advice about avoiding pesticide use.

The Stephens trial started as an in-person proceeding but was changed to a Zoom trial due to concerns about the spread of Covid-19, and has been plagued by repeated “technical problems” ever since the change. Several times jurors and/or a witness have lost their audio and/or video connections to the trial.

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

The trial does not resume until Monday Oct. 4 because of scheduling conflicts for some of the trial participants.