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

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

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

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

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

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

More Than Two Years

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

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

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

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

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

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

Preemption Argument

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

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

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

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

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

Bayer settlement

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

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

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

New analysis of glyphosate industry studies finds them outdated, flawed

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

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

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

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

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

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

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

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

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

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

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

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

Regulatory renewal sought

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

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

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

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

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

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

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

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

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

Once-secret studies

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

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

European Assessment Group on Glyphosate report on glyphosate renewal

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

Comments concerning the mutagenic/genotoxic properties of glyphosate

Toxicological and Metabolism Studies summary by industry

Albaugh 2014 glyphosate reverse mutation assay Switzerland

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

Dow Chemical 2012 Micronucleus test of glyphosate TGAI in mice

Industrias Afrasa 2012 reverse mutation with glyphosate

Helm 2010 Reverse Mutation Assay glyphosate using bacteria

Helm 2010 reverse mutation assay 

Helm 2010 mutagenicity of glyphosate testing

Helm 2009 mutagenicity study of glyphosate Germany

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

Syngenta 2009 glyphosate reverse mutation

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

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

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

Helm 2007 Mammalian erythrocyte micronucleus test for glyphosate

Helm Do Brasil 2007 Bacterial reverse mutation test glyphosate

Nufarm 2007 reverse mutation glyphosate technical 05068

Nufarm 2007 1061403 reverse mutation glyphosate technical 05067

Nufarm 2007 1061402 reverse mutation glyphosate technical 05070 

Nufarm 2005 glyphosate technical micronucleus test in the mouse

Monsanto 1998 Mouse micronucleus screening assay of MON-0818

Zeneca Glyphosate 1998 acid Invitro 

Cheminova 1996 reverse mutation glyphosate Brazil

Cheminova 1996 A micronucleus study in mice for the product GILFOS

Zeneca 1996 glyphosate mutagenicity potential

Zeneca 1996 Glyphosate acid mouse bone marrow micronucleus test

Zeneca 1996 glyphosate acid mouse lymphoma gene mutation assay

Sanko 1995 glyphosate in vitro cytogenetics

Sanko 1995 glyphosate DNA Repair Test

Sankyo 1995 reverse mutation study 

Mastra and Maruzen Kako 1995 Technical glyphosate

Mastra and Maruzen Kako 1995 reverse mutation assay glyphosate

Agrichem 1995 Evaluation of ability of glyphosate to induce chromosome aberrations

Feinchemie Schwebda 1994 DNA repair test with primary rat hepatocytes

Feinchemie Schwebda 1994 in vivo mammalian bone marrow cytogenetic test

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

Feinchemie Schwebda 1992 Dominant lethal test in Wistar rats

Monsanto 1992 Mouse micronucleus study of Roundup

Monsanto 1992 glyphosate mutagenicity assay on Roundup

Monsanto 1992 Mouse micronucleus study of RODEO glyphosate formulation

Monsanto 1992 glyphosate mutagenicity assay on RODEO herbicide

Monsanto 1992 mouse micronucleus study of DIRECT formulation

Monsanto 1992 glyphosate mutagenicity potential DIRECT brand

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

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

Cheminova 1991 #12323 glyphosate mutagenicity test

Cheminova 1991 #12324 Mutagenicity test micronucleus glyphosate

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

Monsanto 1990 Ames Salmonella mutagenicity assay of MON 0818

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

Monsanto 1983 glyphosate gene mutation assay

Monsanto 1981 Ames salmonella mutagenicity assay of MON 8080

Monsanto 1980 Dominant lethal mutagenicity assay with technical glyphosate in mice

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

Glyphosate Fact Sheet: Cancer and Other Health Concerns

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Glyphosate, a synthetic herbicide patented in 1974 by the Monsanto Company and now manufactured and sold by many companies in hundreds of products, has been associated with cancer and other health concerns. Glyphosate is best known as the active ingredient in Roundup-branded herbicides, and the herbicide used with “Roundup Ready” genetically modified organisms (GMOs).

Herbicide tolerance is the most prevalent GMO trait engineered into food crops, with some 90% of corn and 94% of soybeans in the U.S. engineered to tolerate herbicides, according to USDA data. A 2017 study found that Americans’ exposure to glyphosate increased approximately 500 percent since Roundup Ready GMO crops were introduced in the U.S in 1996. Here are some key facts about glyphosate:

Most Widely Used Pesticide

According to a February 2016 study, glyphosate is the most widely used pesticide: “In the U.S., no pesticide has come remotely close to such intensive and widespread use.” Findings include:

  • Americans have applied 1.8 million tons of glyphosate (or 1.6 billion kilograms) since its introduction in 1974 to 2014. 
  • Worldwide 9.5 million tons (or 8.6 billion kilograms) of the chemical has been sprayed on fields – enough to spray nearly half a pound of Roundup on every cultivated acre of land in the world, according to an examination of data from 1994-2014.
  • Globally, glyphosate use has risen almost 15-fold since Roundup Ready GMO crops were introduced. 
  • Approximately 281 million pounds of glyphosate was applied to 298 million acres annually in U.S. agricultural settings, on average, from 2012 to 2016, according to the Environmental Protection Agency. Most glyphosate was applied to soybean (117.4 million lbs applied annually), corn (94.9 million lbs applied annually), and cotton (20 million lbs applied annually). Many citrus fruits, including grapefruit, oranges, and lemons, and field crops such as soybeans, corn, and cotton have  high percentages of their acres treated with glyphosate. Approximately 24 million pounds of glyphosate are applied to non-agricultural sites annually, on average, from 2012 through 2016, according to EPA.  The majority of non-agricultural use is in the homeowner market. About 5 million lbs is applied annually for residential use.

Statements from scientists and health care providers 

Cancer Concerns

The scientific literature and regulatory conclusions regarding glyphosate and glyphosate-based herbicides show a mix of findings, making the safety of the herbicide a hotly debated subject. 

In 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) classified glyphosate as “probably carcinogenic to humans” after reviewing years of published and peer-reviewed scientific studies. The team of international scientists found there was a particular association between glyphosate and non-Hodgkin lymphoma.

U.S. agencies: At the time of the IARC classification, the Environmental Protection Agency (EPA) was conducting a registration review. The EPA’s Cancer Assessment Review Committee (CARC) issued a report in September 2016 concluding that glyphosate was “not likely to be carcinogenic to humans” at doses relevant to human health. In December 2016, the EPA convened a Scientific Advisory Panel to review the report; members were divided in their assessment of EPA’s work, with some finding the EPA erred in how it evaluated certain research. Additionally, the EPA’s Office of Research and Development determined that EPA’s Office of Pesticide Programs had not followed proper protocols in its evaluation of glyphosate, and said the evidence could be deemed to support a “likely” carcinogenic or “suggestive” evidence of carcinogenicity classification. Nevertheless the EPA issued a draft report on glyphosate in December 2017 continuing to hold that the chemical is not likely to be carcinogenic. In April 2019, the EPA reaffirmed its position that glyphosate poses no risk to public health. But earlier that same month, the U.S. Agency for Toxic Substances and Disease Registry (ATSDR) reported that there are links between glyphosate and cancer. According to the draft report from ATSDR, “numerous studies reported risk ratios greater than one for associations between glyphosate exposure and risk of non-Hodgkin’s lymphoma or multiple myeloma.” 

The EPA issued an Interim Registration Review Decision in January 2020 with updated information about its position on glyphosate, continuing to hold the position that glyphosate is unlikely to cause cancer. 

European Union: The European Food Safety Authority and the European Chemicals Agency have said glyphosate is not likely to be carcinogenic to humans. A March 2017 report by environmental and consumer groups argued that regulators relied improperly on research that was directed and manipulated by the chemical industry. A 2019 study found that Germany’s Federal Institute for Risk Assessment report on glyphosate, which found no cancer risk, included sections of text that had been plagiarized from Monsanto studies.  In February 2020, reports surfaced that 24 scientific studies submitted to the German regulators to prove the safety of glyphosate came from a large German laboratory that has been accused of fraud and other wrongdoing.

In June 2021, the European Union’s (EU) Assessment Group on Glyphosate (AGG) issued an 11,000-page draft report concluding that glyphosate is safe when used as directed and does not cause cancer. The finding is based in part on a dossier of roughly 1,500 studies submitted to European regulators by the “Glyphosate Renewal Group (GRG),” a collection of companies that includes Monsanto owner Bayer AG. The companies are seeking the renewal of the EU authorization of glyphosate. Current authorization in Europe expires in December 2022. The companies say they also gave regulators a “literature review” of around 12,000 published scientific articles on glyphosate.

WHO/FAO Joint Meeting on Pesticide Residues determined in 2016 that glyphosate was unlikely to pose a carcinogenic risk to humans from exposure through the diet, but this finding was tarnished by conflict of interest concerns after it came to light that the chair and co-chair of the group also held leadership positions with the International Life Sciences Institute, a group funded in part by Monsanto and one of its lobbying organizations.

California OEHHA: On March 28, 2017, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment confirmed it would add glyphosate to California’s Proposition 65 list of chemicals known to cause cancer. Monsanto sued to block the action but the case was dismissed. In a separate case, the court found that California could not require cancer warnings for products containing glyphosate. On June 12, 2018, a U.S. District Court denied the California Attorney General’s request for the court to reconsider the decision. The court found that California could only require commercial speech that disclosed “purely factual and uncontroversial information,” and the science surrounding glyphosate carcinogenicity was not proven.

Agricultural Health Study: A long-running U.S. government-backed prospective cohort study of farm families in Iowa and North Carolina has not found any connections between glyphosate use and non-Hodgkin lymphoma, but the researchers reported that “among applicators in the highest exposure quartile, there was an increased risk of acute myeloid leukemia (AML) compared with never users…” The most recent published update to the study was made public in late 2017.

Recent studies linking glyphosate to cancer and other health concerns 

Cancer

Endocrine disruption, fertility and reproductive concerns 

Liver disease 

  • A 2017 study associated chronic, very low-level glyphosate exposures to non-alcoholic fatty liver disease in rats. According to the researchers, the results “imply that chronic consumption of extremely low levels of a GBH formulation (Roundup), at admissible glyphosate-equivalent concentrations, are associated with marked alterations of the liver proteome and metabolome,” the biomarkers for NAFLD.

Microbiome disruption

  • November 2020 paper in the Journal of Hazardous Materials reports that approximately 54 percent of species in the core of the human gut microbiome are “potentially sensitive” to glyphosate. With a “large proportion” of bacteria in the gut microbiome susceptible to glyphosate, the intake of glyphosate “may severely affect the composition of the human gut microbiome,” the authors said in their paper. 
  • A 2020 literature review of glyphosate’s effects on the gut microbiome concludes that, “glyphosate residues on food could cause dysbiosis, given that opportunistic pathogens are more resistant to glyphosate compared to commensal bacteria.” The paper continues, “Glyphosate may be a critical environmental trigger in the etiology of several disease states associated with dysbiosis, including celiac disease, inflammatory bowel disease and irritable bowel syndrome. Glyphosate exposure may also have consequences for mental health, including anxiety and depression, through alterations in the gut microbiome.”
  • A 2018 rat study conducted by the Ramazzini Institute reported that low-dose exposures to Roundup at levels considered safe significantly altered the gut microbiota in some of the rat pups.
  • Another 2018 study reported that higher levels of glyphosate administered to mice disrupted the gut microbiota and caused anxiety and depression-like behaviors.

Harmful impacts bees and monarch butterflies

Cancer lawsuits

More than 42,000 people have filed suit against Monsanto Company (now Bayer) alleging that exposure to Roundup herbicide caused them or their loved ones to develop non-Hodgkin lymphoma (NHL), and that Monsanto covered up the risks. As part of the discovery process, Monsanto has had to turn over millions of pages of internal records. We are posting these Monsanto Papers as they become available. For news and tips about the ongoing legislation, see Carey Gillam’s Roundup Trial Tracker. The first three trials ended in large awards to plaintiffs for liability and damages, with juries ruling that Monsanto’s weed killer was a substantial contributing factor in causing them to develop NHL. Bayer is appealing the rulings. 

Monsanto influence in research: In March 2017, the federal court judge unsealed some internal Monsanto documents that raised new questions about Monsanto’s influence on the EPA process and about the research regulators rely on. The documents suggest that Monsanto’s long-standing claims about the safety of glyphosate and Roundup do not necessarily rely on sound science as the company asserts, but on efforts to manipulate the science

More information about scientific interference

Sri Lankan scientists awarded AAAS freedom award for kidney disease research

The AAAS has awarded two Sri Lankan scientists, Drs. Channa Jayasumana and Sarath Gunatilake, the 2019 Award for Scientific Freedom and Responsibility for their work to “investigate a possible connection between glyphosate and chronic kidney disease under challenging circumstances.” The scientists have reported that glyphosate plays a key role in transporting heavy metals to the kidneys of those drinking contaminated water, leading to high rates of chronic kidney disease in farming communities. See papers in  SpringerPlus (2015), BMC Nephrology (2015), Environmental Health (2015), International Journal of Environmental Research and Public Health (2014). The AAAS award had been suspended amidst a fierce opposition campaign by pesticide industry allies to undermine the work of the scientists. After a review, the AAAS reinstated the award

Desiccation: another source of dietary exposures 

Some farmers use glyphosate on non-GMO crops such as wheat, barley, oats, and lentils to dry down the crop ahead of harvest in order to accelerate the harvest. This practice, known as desiccation, may be a significant source of dietary exposure to glyphosate.

Glyphosate in food: U.S. drags its feet on testing

The USDA quietly dropped a plan to start testing food for residues of glyphosate in 2017. Internal agency documents obtained by U.S. Right to Know show the agency had planned to start testing over 300 samples of corn syrup for glyphosate in April 2017. But the agency killed the project before it started. The U.S. Food and Drug Administration began a limited testing program in 2016, but the effort was fraught with controversy and internal difficulties and the program was suspended in September 2016. Both agencies have programs that annually test foods for pesticide residues but both have routinely skipped testing for glyphosate.

Before the suspension, one FDA chemist found alarming levels of glyphosate in many samples of U.S. honey, levels that were technically illegal because there have been no allowable levels established for honey by the EPA. Here is a recap of news about glyphosate found in food:

Pesticides in our food: Where’s the safety data?

USDA data from 2016 shows detectable pesticide levels in 85% of more than 10,000 foods sampled, everything from mushrooms to grapes to green beans. The government says there are little to no health risks, but some scientists say there is little to no data to back up that claim. See “Chemicals on our food: When “safe” may not really be safe: Scientific scrutiny of pesticide residue in food grows; regulatory protections questioned,” by Carey Gillam (11/2018).

Elderly woman to take on Monsanto in next trial over cancer claims

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An elderly California woman who was a regular user of Monsanto’s Roundup weed killer for more than 30 years is set as the next person to try to prove that exposure to the chemical causes non-Hodgkin lymphoma, a claim already won by plaintiffs in three previous trials.

The case of Donnetta Stephens v. Monsanto is set for trial July 19 in San Bernardino County Superior Court in California. Stephens from Yucaipa, California was diagnosed with non-Hodgkin lymphoma (NHL) in 2017 and has suffered from numerous health complications amid multiple rounds of chemotherapy since then. Because of her poor health,  a judge in December granted Stephens a trial “preference,” meaning her case was expedited, after her lawyers informed the court that Stephens is “in a perpetual state of pain,” and losing cognition and memory.

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

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

Some old evidence, some new

The Stephens case is expected to involve many of the same expert witnesses and same documents and deposition testimony that helped plaintiffs win the prior trials, said Stephens’ lawyer Fletch Trammell. Two new experts who have not testified previously in Roundup trials will be called, however, said Trammell. They are Barry Boyd, an oncologist from Yale Cancer Center, and Luoping Zhang, an adjunct professor of toxicology at the School of Public Health at the University of California, Berkeley.

Zhang is the lead author of a meta-analysis published in 2019 that determined research showed “a compelling link” between exposures to glyphosate-based herbicides, such as Roundup, and increased risk for NHL.  The analysis found that people with high exposures to the popular pesticides have a 41 percent increased risk of developing NHL.

Monsanto has long maintained that there is no legitimate scientific research showing a definitive association between glyphosate and NHL or any type of cancer. A 2020 meta-analysis could be useful to  Monsanto’s defense. That report concluded that there is “no overall evidence of an increased risk” for NHL “in subjects occupationally exposed to glyphosate.”

The Environmental Protection Agency has supported the safety of glyphosate products, saying the agency’s analysis of scientific evidence shows the chemical is “not likely” to cause cancer.

The company claims the scientists with the International Agency for Research on Cancer (IARC),  who classified glyphosate as a probable human carcinogen, engaged in improper conduct and failed to give adequate weight to several important studies.

But the juries in the three prior trials found the evidence so overwhelming in favor of plaintiffs that they awarded the plaintiff in the first trial $289 million; the plaintiff in the second trial $80 million; and more than $2 billion to the husband-and-wife plaintiffs in the third trial. All the awards were reduced sharply by judges involved in the cases but the verdicts assigning blame to Monsanto for the cancers have not been overturned.

Bayer settlement issues

Bayer said last year that it had agreed to pay close to $11 billion to settle close to 100,000 Roundup cancer claims, but many law firms have dismissed the individual offers for their clients as insufficient, and they continue to press for more trials.

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

There are thousands of plaintiffs still awaiting either settlement offers or trial settings, and as they wait, the deaths mount. Another woman who was granted a trial preference in a December court order, died only a month later, in January. 

The last trial held concluded in May 2019. Since then several other trials have been scheduled but Monsanto settled each case before the trials started.

Trammell said so far Monsanto has not made any settlement offer for the Stephens case and has made only what he called “nuisance value” five-figure offers for other clients he represents.

“She used Roundup for over 30 years, and had heavy exposure,” Trammell said of Stephens. “There is no non-Hodgkin anywhere in her family tree.  They are rolling out the same defenses and I think they’re going to lose on the same grounds.”

According to court filings, Stephens health has deteriorated significantly in the last year:

“The pain and weakness Ms. Stephens experiences in her feet and legs cause her to stumble and fall frequently, and she relies on her husband to walk behind her in case she should fall. Id. Because of this pain and weakness, Ms. Stephens is no longer able to drive a car. Ms. Stephens also suffers from
severe vertigo and very regularly passes out due to the intense dizziness she experiences. 
Formerly, Ms. Stephens was an active individual who loved to tend to her neighbors’ gardens.
Now, she can barely walk and must use a cane or walker to support herself.  Her physician
has informed her that she will need a wheelchair in the near future. Using her own word, Ms.
Stephens describes the pain she experiences as though she is getting shot through with electricity.
As this description reflects, the pain Ms. Stephens experiences is relentless, unabated, and all-consuming, causing this once former active individual to live her life in a perpetual state of fear of undertaking the simple task of movement.”

Bayer did not respond to a request for comment.

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

Judge shoots down Bayer’s plan to limit future Roundup legal liability, issues harsh criticism

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(UPDATED May 27 with Bayer statement about new plans)

The federal judge overseeing nationwide Roundup litigation on Wednesday denied Bayer’s latest attempt to limit its legal liability from future cancer claims associated with its glyphosate-based herbicides, citing numerous “glaring flaws” in a settlement proposed to apply to Roundup users who have not yet sued the company but may want to do so in the future.

Saying parts of the plan were “clearly unreasonable” and unfair to cancer sufferers who would be part of the class settlement, U.S. Judge Vince Chhabria castigated Bayer and the small group of lawyers who put the plan together in conjunction with Bayer.

He pointed out that the company has been “losing trials left and right” in claims brought by people suffering from non-Hodgkin lymphoma (NHL) who alleged exposure to Monsanto’s Roundup and other glyphosate-based herbicides were the cause.

Bayer has owned Monsanto since 2018 and has been struggling to defend the cancer claims ever since. Cancer victims have won three trials held to date, and tens of thousands of other plaintiffs have filed lawsuits alleging exposure to Monsanto’s herbicides caused them to develop NHL while Monsanto spent decades hiding the risks.

Elizabeth Cabraser, one of the lawyers who structured the settlement plan, said the proponents were “disappointed” by the ruling and “continue to believe that a multi-billion-dollar class settlement that includes free legal services and substantial compensation to claimants, NHL diagnostic assistance, research into NHL treatment, and Roundup label reform to inform users and the public on all the science regarding a Roundup/NHL link, would provide tremendous financial, health and safety benefits for class members.”

But one of the lead objectors to the plan, lawyer Majed Nachawati, said Cabraser had attempted to “create a sham settlement” that would have harmed the legal rights of “thousands of injured Americans.”

Bayer issued a statement following the judge’s order saying it would consider “the future of glyphosate-based products in the U.S. residential market,” though any changes there would “not affect the availability of glyphosate-based products in markets for professional and agricultural users.” The company said discussions about the future of residential Roundup products was part of a “five-point plan” the company would now pursue.

“The new package of measures, which combine a number of legal and commercial actions, is designed to help the company achieve a level of risk mitigation that is comparable to the previously proposed national class solution,” Bayer said.

Evidence favors plaintiffs, judge says

Judge Chhabria said in his decision that the company’s desire to set up a “science panel” to determine whether or not the herbicides actually cause cancer rather than leave that question to future juries is because of the trial losses the company has so far suffered.

The “reason Monsanto wants a science panel so badly is that the company has lost the ‘battle of the experts’ in three trials, the judge wrote in his order.  “At present, the playing field on the issue of expert testimony related to causation is slanted heavily in favor of plaintiffs.”

The ruling comes after a lengthy hearing last week held to discuss widespread opposition by personal injury attorneys across the United States to the settlement proposal. The proposed plan called for Bayer to put up roughly $2 billion for a series of actions that would help the company avoid future Roundup cancer trials.

The class action settlement would apply to people exposed to Roundup products as of Feb. 3, 2021 who have not yet sued Monsanto or retained a lawyer to do so. The settlement plan would set up a framework for addressing new claims brought by those exposed individuals who develop NHL they attribute to their Roundup exposure. It would apply to people who already have NHL but who have not yet sued the company and to people who develop NHL in the future.

The plan was structured by Bayer in coordination with a small team of plaintiffs’ lawyers who stood to be paid millions of dollars for their participation.

Proponents of the proposed class action plan told the judge it “will save lives,” and provide “speedy compensation” to people who get NHL they blame on Roundup exposure.

But opponents said the proposal actually did little for cancer patients while benefiting Bayer and the lawyers who helped develop the plan.

At the heart of the objections is the view that if approved, the class action plan could limit the due process rights of people to go to trial and seek punitive damages awards in the future if they are diagnosed with NHL after Roundup exposure, while allowing Bayer to keep selling Roundup products with no express warning of a cancer risk on the label.

The limiting of plaintiffs’ ability to seek punitive damages while not limiting Bayer’s ability to keep selling Roundup distinguishes this settlement from any similar class action, according to an opposition brief filed by the nonprofit legal group Public Justice. The plan is a “blueprint for how manufacturers can cut off victims’ rights to seek punitive damages from injuries caused by hazardous pesticides, the group said.

Another key problem with the plan, according to critics, is that everyone in the United States who meets the criteria as a potential plaintiff would automatically become part of the class and subject to its provisions if they did not actively opt out of the class within a specified time period. If people did not opt out – even if they didn’t know about the plan – they would be stripped of  the right to seek punitive damages if they ever did file a lawsuit.

“Monsanto tried to buy its own system of justice and it is wonderful that the court saw through what they were trying to do,” said lawyer Gerson Smoger, who is among the opponents.  “The settlement would’ve been a travesty for those who use Roundup.”

Separate from larger settlement

The class action plan, which is separate from an $11 billion settlement of Roundup litigation announced by Bayer last June to address already filed lawsuits, needs approval from Chhabria. The judge has been overseeing the federal multidistrict Roundup litigation involving thousands of plaintiffs from around the United States.

Bayer’s desire to find a settlement is “not surprising because the alternative to settling – continuing to lose trials left and right – is not attractive,” the judge wrote in his ruling.

“In sum, the settlement proposed by these attorneys would accomplish a lot for Monsanto,” he wrote. “It would substantially diminish the company’s settlement exposure and litigation exposure at the
back end, eliminating punitive damages and potentially increasing its chances of winning trials
on compensatory damages. It would accomplish far less for the Roundup users who have not
been diagnosed with NHL—and not nearly as much as the attorneys pushing this deal contend.”

Bayer’s new plan

Bayer said in addition to consideration of withdrawing Roundup from residential use, the company’s  plan includes the following:

  • Creation and promotion of a new website with scientific studies relevant to Roundup safety, and a request that EPA approves corresponding language on Roundup labels.
  • Exploration of the creation of an independent scientific advisory panel comprised of external scientific experts to review scientific information regarding the safety of Roundup. The results would be released publicly and added to the new website.
  • Continuation of settlement discussions and continuing appeals of the two of the three cases lost at trial. The company already exhausted appeals in the first case it lost at trial. Bayer is hoping to get a case to the U.S. Supreme Court and get a favorable ruling on its position that state-based failure-to-warn claims conflict with, and are preempted by, federal law.

Another loss for Bayer over Roundup cancer claims as appeals court shoots down preemption argument

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In a blow to Monsanto owner Bayer AG’s bid to block continued liability over Roundup cancer litigation, a federal appeals court shot down the company’s argument that federal regulatory backing of the company’s herbicides preempts claims made by cancer patient Edwin Hardeman.

In a ruling issued Friday, the U.S. Court of Appeals for the Ninth Circuit affirmed the district court’s judgment in favor of Hardeman, and said Monsanto erred in asserting that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) preempts state laws and a duty to warn.

The company’s primary hope since losing all three of three trials held to date is to get a U.S. Supreme Court finding that the U.S. Environmental Protection Agency’s approval of its products under FIFRA  essentially bars complaints that Monsanto didn’t warn of any cancer risk with its herbicides.

The preemption argument is seen as weak by many legal experts because a 2005 U.S. Supreme Court ruling in a case titled Bates v. Dow Agrosciences established that the EPA’s approval of a product does not rule out claims of a failure to warn brought under state law, and FIFRA expressly states that EPA approval doesn’t constitute an absolute defense.

“It’s a dead duck in the water,” Hardeman lawyer Aimee Wagstaff said of the preemption defense. “They need to let that one go.”

Unanimous verdict

Hardeman won a unanimous jury verdict in March 2019 claiming that exposure to Monsanto’s glyphosate-based herbicide products caused his non-Hodgkin lymphoma. He initially was awarded $80 million but the punitive damages were reduced by the trial judge from $75 million to $20 million, leaving him with a total award of approximately $25 million.

The evidence in his case, “showed the carcinogenic risk of glyphosate was knowable at the time of Hardeman’s exposure,” the appeals court ruling states.

The Hardeman case is one of tens of thousands pending against Monsanto for which Bayer is liable after purchasing the company in June of 2018. After Bayer bought Monsanto, four plaintiffs in three trials  won damages against the company. In all, roughly 100,000 U.S. plaintiffs have alleged they developed non-Hodgkin lymphoma after exposure to Monsanto’s glyphosate-based herbicides, such as Roundup. The plaintiffs allege that Monsanto knew for years of scientific evidence showing cancer risks associated with its products, but worked to suppress the information to protect its profits.

In his 2019 ruling cutting the award but upholding the jury finding, U.S. District Judge Vince Chhabria had harsh words for Monsanto, writing: “Despite years of colorable claims in the scientific community that Roundup causes NHL, Monsanto presented minimal evidence suggesting that it was interested in getting to the bottom of those claims… While Monsanto repeatedly intones that it stands by the safety of its product, the evidence at trial painted the picture of a company focused on attacking or undermining the people who raised concerns, to the exclusion of being an objective arbiter of Roundup’s safety.”

Trial lawyers accuse Monsanto, Bayer of “pay-to-appeal scheme,” allege “fraud”

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The lawyers who led the nationwide U.S. Roundup litigation through three trial victories and forced Monsanto owner Bayer AG into an $11 billion settlement have notified a federal court that they have uncovered evidence of fraud in a secret deal between Monsanto and a lone plaintiff’s lawyer who has not been active in the litigation until recently.

In a series of filings made Thursday with the U.S. Court of Appeals for the 11th Circuit, lawyers from three firms involved in the three successful Roundup trials alerted the court to what they said was an effort by Monsanto to “buy” a favorable appellate court ruling.

The agreement between Monsanto and one plaintiff and his attorney is a “pay-to-appeal scheme,” according to plaintiffs’ lawyers Aimee Wagstaff, Brent Wisner and Jennifer Moore.  The legal team asks the court to dismiss the appeal they allege is the focus of the scheme.

The lawyer involved in cutting the deal with Monsanto is Ashleigh Madison of Southeast Law LLC in Savannah, Georgia.  Madison confirmed various terms of the arrangement with Monsanto to Wagstaff’s firm in an email and phone conversations recounted in a declaration, according to the filings made Thursday.

When contacted for comment, Madison denied the allegations and said her client’s best interests are her “top priority.” She said she looks “forward to further addressing the matter before a court of law, as our system of justice intends.”

Bayer, which bought Monsanto in 2018, also said the claims made by Wagstaff, Wisner and Moore are false.  The company issued a statement saying it has been “completely transparent about its desire to appeal Roundup failure-to-warn cases on federal preemption grounds,” and the deal with Madison and her client is “an appropriate path for such an appeal.”

Monsanto has lost all appeals associated with the first case that went to trial, Johnson v. Monsanto, and has appeals pending in the two subsequent trials it lost. Juries in the three trials found the company’s glyphosate-based weed killers such as Roundup caused non-Hodgkin lymphoma suffered by plaintiffs, and that Monsanto failed to warn of the risks.

The company’s primary hope at this point is to get a U.S. Supreme Court finding that the U.S. Environmental Protection Agency’s approval of its products, and stance that those products are not likely to cause cancer, essentially bars complaints that Monsanto didn’t warn of any cancer risk with its herbicides. Monsanto is asserting the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) preempts state laws and a duty to warn.

But a 2005 U.S. Supreme Court ruling in a case titled Bates v. Dow Agrosciences established that the EPA’s approval of a product does not rule out claims of a failure to warn brought under state law, and FIFRA expressly states that EPA approval doesn’t constitute an absolute defense. Citing the law and the precedent, more than a dozen federal and state courts have rejected the preemption argument, according to the filing submitted Thursday by the plaintiffs’ lawyers.

If Bayer can force one of the weaker cases to the U.S. Supreme Court and win on preemption, it would thwart the key claims brought by tens of thousands of plaintiffs and likely save Bayer from significant ongoing legal liability costs.

Georgia judge decision

At the heart of the matter is one case, that of Carson v. Monsanto, filed in 2017. The case alleged that plaintiff John Carson developed malignant fibrous histiocytoma (MFH) from exposure to Roundup. The legal team for the nationwide litigation point out in their filing this week that while there is robust scientific evidence associating Roundup exposure to NHL, there is a lack of scientific evidence associating Roundup to MFH, differentiating the case from the bulk of others filed against the company.

The case languished until Monsanto filed a motion with U.S. District Judge R. Stan Baker in Savannah, Georgia seeking a judgment in its favor on the issue of federal preemption. The district court judge found in favor of Monsanto, agreeing the Carson claim was preempted and the company had no duty to warn of a cancer risk. The judge ruled in favor of Carson, however, on claims that Monsanto was negligent and the design of Roundup products was defective.

Monsanto has since told Carson and his attorney to drop the claims they won on and appeal the preemption ruling they lost, according to the declaration filed by David Wool, a lawyer in the Andrus Wagstaff plaintiffs’ firm.

“Monsanto’s counsel, Martin Calhoun of Hollingsworth LLP, told Madison that Monsanto would never pay her client anything unless he appealed the District Court’s preemption decision – a decision that Monsanto won – and that Monsanto was offering to pay Carson money to appeal the decision,” the declaration states.

Monsanto agreed to pay Carson an undisclosed sum only if he will appeal the decision, according to the new court filing. If he does not drop the claims he won and appeal the preemption matter Monsanto has threatened to make him pay nearly $100,000 in legal fees and costs, according to information turned up by Wagstaff, Wisner and Moore’s law firms.

Carson is required by the deal to appeal only the preemption issue and no other elements of his claims, the legal challenge states:

“While Monsanto’s Civil Appeal Statement suggests it paid Carson to settle his claims not subject to this appeal, in truth, it did no such thing. Payment of the first sum was tied to noticing the appeal, not dismissal of any of Carson’s claims. Carson’s attorney openly admits that Monsanto would never pay Carson unless he appealed the district court’s preemption ruling and corroborated, in writing, that the settlement agreement requires Carson to appeal. If Carson does not appeal, he does not get paid. Indeed, his appeal is so central to getting paid that if he elects to not appeal, he is not only bereft of any settlement, but he is also subject to hefty  liquidated damages. Monsanto is paying Carson to appeal and then threatening him if he does not follow through.

“This appeal should be dismissed—any other result would set a dangerous precedent of appellate review being “for sale” to deep-pocketed litigants. This appeal should be dismissed—any other result would set a dangerous precedent of appellate review being “for sale” to deep-pocketed litigants.”

Allowing the Monsanto-manufactured appeal to go forward “risks turning the justice system on its head by allowing deep-pocketed parties to attempt to broaden the scope of favorable rulings they receive by coercing their adversaries to appeal. This Court’s decisions should not be for sale,” the plaintiffs’ team states in their filing. “This sort of judicial manipulation must be loudly and forcefully rejected.”

Monsanto “ulterior motives”

The declaration filed by Wool recounts conversations with Madison, Carson’s attorney. He states: “On March 15, 2021 I called attorney Ashleigh Madison. During the conversation, Madison confirmed her client’s settlement agreement with Monsanto in the Carson case, and stated that the “first payment” was triggered by filing a notice of appeal.  I expressed my concern that Monsanto had concocted this settlement agreement in an attempt to create favorable appellate law for itself. Madison confirmed that this was her understanding as well, stating that she believed Monsanto had “ulterior motives.”

According to Wool, Madison said her client had only a “very slim chance” of winning the appeal Monsanto was inducing them to file. Still, her client would obtain a “high” value from Monsanto, she told Wool, according to the declaration.

In their letter brief to the court, the trial lawyers said because Carson’s counsel admits that Monsanto is paying Carson to appeal a decision Monsanto won at in order to create appellate precedent, the case “warrants immediate dismissal.”

Litigants “cannot buy appellate review of decisions they won. The Court should reject this attempt to manipulate our judicial system and dismiss the appeal with prejudice because Carson and Monsanto are
deceiving the Court by claiming that an actual case or controversy exists when, in truth, this
appeal was bought and paid for by Monsanto,” they wrote. The Carson agreement “erodes the very foundation of our justice system, which is premised on the principle that opposing parties are actually adversarial—not paying each other to manufacture controversies and seek advisory opinions.”

Bayer said in its statement that the trio of trial lawyers are mischaracterizing the facts.

“Under the settlement, the company agreed to pay Carson $100,000 to drop the surviving design defect claims and to pursue the preemption ruling against him,” Bayer said in the statement. “If he succeeds in the appeal, he gets an additional substantial payment. If Carson drops the appeal, he would simply have to return the $100,000 settlement payment because he would be in breach of its terms. Thus, plaintiffs’ characterization of the $100,000 as a ‘penalty’ in a court filing is completely false, and nothing more than an effort to block this appeal on federal preemption grounds which threatens their interests in this litigation.”

International Life Sciences Institute (ILSI) is a Food Industry Lobby Group

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The International Life Sciences Institute (ILSI) is a corporate-funded nonprofit organization based in Washington DC, with 17 affiliated chapters around the world. ILSI describes itself as a group that conducts “science for the public good” and “improves human health and well-being and safeguards the environment.” However, investigations by academics, journalists and public interest researchers show that ILSI is a lobby group that protects the interests of the food industry, not public health.

Recent news

  • An April 2021 study in Globalization and Health documents how ILSI plays a key role in helping the food industry shape scientific principles by promoting the acceptance of public-private partnerships and permissiveness about conflicts of interest. 
  • Coca-Cola has severed its longtime ties with ILSI. The move is “a blow to the powerful food organization known for its pro-sugar research and policies,” Bloomberg reported in January 2021.  
  • ILSI helped Coca-Cola Company shape obesity policy in China, according to a September 2020 study in the Journal of Health Politics, Policy and Law by Harvard Professor Susan Greenhalgh. “Beneath ILSI’s public narrative of unbiased science and no policy advocacy lay a maze of hidden channels companies used to advance their interests. Working through those channels, Coca Cola influenced China’s science and policy making during every phase in the policy process, from framing the issues to drafting official policy,” the paper concludes.

  • Documents obtained by U.S. Right to Know add more evidence that ILSI is a food industry front group. A May 2020 study in Public Health Nutrition based on the documents reveal “a pattern of activity in which ILSI sought to exploit the credibility of scientists and academics to bolster industry positions and promote industry-devised content in its meetings, journal, and other activities.” See coverage in The BMJ, Food and drink industry sought to influence scientists and academics, emails show  (5.22.20)

  • Corporate Accountability’s April 2020 report examines how food and beverage corporations have leveraged ILSI to infiltrate the U.S. Dietary Guidelines Advisory Committee, and cripple progress on nutrition policy around the globe. See coverage in The BMJ, Food and soft drink industry has too much influence over US dietary guidelines, report says (4.24.20) 

  • New York Times investigation by Andrew Jacobs reveals that a trustee of the industry-funded nonprofit ILSI advised the Indian government against going ahead with warning labels on unhealthy foods. The Times described ILSI as a “shadowy industry group” and “the most powerful food industry group you’ve never heard of.” (9.16.19) The Times cited a June study in Globalization and Health co-authored by Gary Ruskin of U.S. Right to Know reporting that ILSI operates as a lobby arm for its food and pesticide industry funders.

  • The New York Times revealed the undisclosed ILSI ties of Bradley C. Johnston, a co-author of five recent studies claiming red and processed meat don’t pose significant health problems. Johnston used similar methods in an ILSI-funded study to claim sugar is not a problem. (10.4.19)

  • Marion Nestle’s Food Politics blog, ILSI: true colors revealed (10.3.19)

ILSI ties to Coca-Cola 

ILSI was founded in 1978 by Alex Malaspina, a former senior vice president at Coca-Cola who worked for Coke from 1969-2001. Coca-Cola has kept close ties with ILSI. Michael Ernest Knowles, Coca-Cola’s VP of global scientific and regulatory affairs from 2008–2013, was president of ILSI from 2009-2011. In 2015, ILSI’s president was Rhona Applebaum, who retired from her job as Coca-Cola’s chief health and science officer (and from ILSI) in 2015 after the New York Times and Associated Press reported that Coke funded the nonprofit Global Energy Balance Network to help shift blame for obesity away from sugary drinks.  

Corporate funding 

ILSI is funded by its corporate members and company supporters, including leading food and chemical companies. ILSI acknowledges receiving funding from industry but does not publicly disclose who donates or how much they contribute. Our research reveals:

  • Corporate contributions to ILSI Global amounting to $2.4 million in 2012. This included $528,500 from CropLife International, a $500,000 contribution from Monsanto and $163,500 from Coca-Cola.
  • A draft 2013 ILSI tax return shows ILSI received $337,000 from Coca-Cola and more than $100,000 each from Monsanto, Syngenta, Dow Agrisciences, Pioneer Hi-Bred, Bayer CropScience and BASF.
  • A draft 2016 ILSI North America tax return shows a $317,827 contribution from PepsiCo, contributions greater than $200,000 from Mars, Coca-Cola, and Mondelez, and contributions greater than $100,000 from General Mills, Nestle, Kellogg, Hershey, Kraft, Dr. Pepper, Snapple Group, Starbucks Coffee, Cargill, Uniliver and Campbell Soup.  

Emails show how ILSI seeks to influence policy to promote industry views 

A May 2020 study in Public Health Nutrition adds evidence that ILSI is a food industry front group. The study, based on documents obtained by U.S. Right to Know via state public records requests, reveals how ILSI promotes the interests of the food and agrichemical industries, including ILSI’s role in defending controversial food ingredients and suppressing views that are unfavorable to industry; that corporations such as Coca-Cola can earmark contributions to ILSI for specific programs; and, how ILSI uses academics for their authority but allows industry hidden influence in their publications.

The study also reveals new details about which companies fund ILSI and its branches, with hundreds of thousands of dollars in contributions documented from leading junk food, soda and chemical companies.

A June 2019 paper in Globalization and Health provides several examples of how ILSI advances the interests of the food industry, especially by promoting industry-friendly science and arguments to policymakers. The study is based on documents obtained by U.S. Right to Know via state public records laws.  

The researchers concluded: “ILSI seeks to influence individuals, positions, and policy, both nationally and internationally, and its corporate members deploy it as a tool to promote their interests globally. Our analysis of ILSI serves as a caution to those involved in global health governance to be wary of putatively independent research groups, and to practice due diligence before relying upon their funded studies and/or engaging in relationship with such groups.”   

ILSI undermined obesity fight in China

In January 2019, two papers by Harvard Professor Susan Greenhalgh revealed ILSI’s powerful influence on the Chinese government on issues related to obesity. The papers document how Coca-Cola and other corporations worked through the China branch of ILSI to influence decades of Chinese science and public policy on obesity and diet-related illnesses such as Type 2 diabetes and hypertension. Read the papers:

ILSI is so well-placed in China that it operates from inside the government’s Centre for Disease Control and Prevention in Beijing.

Professor Geenhalgh’s papers document how Coca-Cola and other Western food and beverage giants “helped shape decades of Chinese science and public policy on obesity and diet-related diseases” by operating through ILSI to cultivate key Chinese officials “in an effort to stave off the growing movement for food regulation and soda taxes that has been sweeping the west,” the New York Times reported.  

Additional academic research from U.S. Right to Know about ILSI 

The UCSF Tobacco Industry Documents Archive has over 6,800 documents pertaining to ILSI.  

ILSI sugar study “right out of the tobacco industry’s playbook”

Public health experts denounced an ILSI-funded sugar study published in a prominent medical journal in 2016 that was a “scathing attack on global health advice to eat less sugar,” reported Anahad O’Connor in The New York Times. The ILSI-funded study argued that warnings to cut sugar are based on weak evidence and cannot be trusted.  

The Times story quoted Marion Nestle, a professor at New York University who studies conflicts of interest in nutrition research, on the ILSI study: “This comes right out of the tobacco industry’s playbook: cast doubt on the science,” Nestle said. “This is a classic example of how industry funding biases opinion. It’s shameful.” 

Tobacco companies used ILSI to thwart policy 

A July 2000 report by an independent committee of the World Health Organization outlined a number of ways in which the tobacco industry attempted to undermine WHO tobacco control efforts, including using scientific groups to influence WHO’s decision-making and to manipulate scientific debate surrounding the health effects of tobacco. ILSI played a key role in these efforts, according to a case study on ILSI that accompanied the report. Findings indicate that ILSI was used by certain tobacco companies to thwart tobacco control policies. Senior office bearers in ILSI were directly involved in these actions,” according to the case study. See: 

The UCSF Tobacco Industry Documents Archive has more than 6,800 documents pertaining to ILSI

ILSI leaders helped defend glyphosate as chairs of key panel 

In May 2016, ILSI came under scrutiny after revelations that the vice president of ILSI Europe, Professor Alan Boobis, was also chairman of a UN panel that found Monsanto’s chemical glyphosate was unlikely to pose a cancer risk through diet. The co-chair of the UN Joint Meeting on Pesticide Residues (JMPR), Professor Angelo Moretto, was a board member of ILSI’s Health and Environment Services Institute. Neither of the JMPR chairs declared their ILSI leadership roles as conflicts of interest, despite the significant financial contributions ILSI has received from Monsanto and the pesticide industry trade group. See: 

ILSI’s cozy ties at U.S. Centers for Disease Control and Prevention  

In June 2016, U.S. Right to Know reported that Dr. Barbara Bowman, director of a CDC division charged with preventing heart disease and stroke, tried to help ILSI’s founder Alex Malaspina influence World Health Organization officials to back off policies to reduce sugar consumption. Bowman suggested people and groups for Malaspina to talk to, and solicited his comments on some CDC summaries of reports, the emails show. (Bowman stepped down after our first article was published reporting on these ties.)

This January 2019 study in the Milbank Quarterly describes key emails of Malaspina cozying up to Dr. Bowman. For more reporting on this topic, see: 

ILSI influence on the U.S. Dietary Guidelines Advisory Committee

report by the nonprofit group Corporate Accountability documents how ILSI has major influence on U.S. dietary guidelines via its infiltration of the U.S. Dietary Guidelines Advisory Committee.  The report examines the pervasive political interference of food and beverage transnationals like Coca-Cola, McDonald’s, Nestlé, and PepsiCo, and how these corporations have leveraged the International Life Sciences Institute to cripple progress on nutrition policy across the globe.

ILSI influence in India 

The New York Times reported on ILSI’s influence in India in its article titled, “A Shadowy Industry Group Shapes Food Policy Around the World.”

ILSI has close ties to some Indian government officials and, as in China, the nonprofit has pushed similar messaging and policy proposals as Coca-Cola – downplaying the role of sugar and diet as a cause of obesity, and promoting increased physical activity as the solution, according to the India Resource Center. 

Members of ILSI India’s board of trustees include Coca-Cola India’s director of regulatory affairs and representatives from Nestlé and Ajinomoto, a food additive company, along with government officials who serve on scientific panels that are tasked with deciding about food safety issues.  

Longstanding concerns about ILSI 

ILSI insists it is not an industry lobby group, but concerns and complaints are longstanding about the group’s pro-industry stances and conflicts of interest among the organization’s leaders. See, for example:

Untangle food industry influences, Nature Medicine (2019)

Food agency denies conflict-of-interest claim. But accusations of industry ties may taint European body’s reputation, Nature (2010)

Big Food Vs. Tim Noakes: The Final Crusade, Keep Fitness Legal, by Russ Greene (1.5.17) 

Real Food on Trial, by Dr. Tim Noakes and Marika Sboros (Columbus Publishing 2019). The book describes “the unprecedented prosecution and persecution of Professor Tim Noakes, a distinguished scientist and medical doctor, in a multimillion rand case that stretched over more than four years. All for a single tweet giving his opinion on nutrition.”

New Roundup cancer trials loom despite Bayer settlement efforts

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Ken Moll is girding for battle.

Moll, a Chicago-based personal injury attorney, has dozens of lawsuits pending against the former Monsanto Co., all alleging the company’s Roundup weed killers cause non-Hodgkin lymphoma, and he is now preparing several of those cases for trial.

Moll’s firm is one of a handful that have refused settlement offers made by Monsanto owner Bayer AG, deciding instead to take the fight over the safety of Monsanto’s glyphosate-based herbicide products back into courtrooms around the country.

Though Bayer has assured investors it is bringing closure to the costly Roundup litigation through settlement deals totaling more than $11 billion, new Roundup cases are still being filed, and notably several are positioned for trial, with the earliest set to start in July.

“We’re going forward,” Moll said. “We’re doing this.”

Moll has lined up many of the same expert witnesses who helped win the three Roundup trials held to date. And he plans to rely heavily on the same internal Monsanto documents that provided shocking revelations of corporate misconduct that led juries to award hefty punitive damages to the plaintiffs in each of those trials.

Trial set for July 19

One case with a trial date looming involves a 70-year-old woman named Donnetta Stephens from Yucaipa, California who was diagnosed with non-Hodgkin lymphoma (NHL) in 2017 and has suffered from numerous health complications amid multiple rounds of chemotherapy. Stephens was recently granted a trial “preference,” meaning her case has been expedited, after her lawyers informed the court that Stephens is “in a perpetual state of pain,” and losing cognition and memory. The case is set for trial July 19 in San Bernardino County Superior Court in California.

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

The litigation is not over. It is going to be a continued headache for Bayer and Monsanto,” said Andrew Kirkendall, whose Texas-based firm is helping represent Stephens and other clients seeking speedy trials.

Kirkendall said his firm has lawsuits moving forward to trial in California, Oregon, Missouri, Arkansas and Massachusetts.

This has the potential to be the next asbestos litigation,” he said, referring to decades of lawsuits brought over asbestos-related health problems.

Bayer rejection

Bayer bought Monsanto in June 2018 just as the first Roundup cancer trial was getting underway. Juries in each of the cases that went to trial found that Monsanto’s herbicides do cause cancer and that Monsanto spent decades hiding the risks. Jury awards totaled well over $2 billion, though the judgments have been ordered reduced in the appeals process.

After coming under intense pressure from investors to find a way to cap liability, Bayer announced in June that it had reached a $10 billion settlement to resolve most of more than 100,000 Roundup cancer claims in the United States. Since that time it has been signing deals with law firms around the country, including the firms that have led the litigation since the first suits were filed in 2015. The company is also trying to get court approval for a separate $2 billion plan to try to keep Roundup cancer cases that could be filed in the future from going to trial.

Bayer has been unable to settle with all of the firms with Roundup cancer clients, however. According to multiple plaintiffs’ attorneys, their firms rejected settlement offers because the amounts generally ranged from $10,000 to $50,000 per plaintiff – compensation the attorneys deemed inadequate.

“We said absolutely no,” Moll said.

Another law firm pushing cases forward for trial is the San Diego, California-based Singleton Law Firm, which has roughly 400 Roundup cases pending in Missouri and about 70 in California.

The firm is seeking an expedited trial now for 76-year-old Joseph Mignone, who was diagnosed with NHL in 2019. Mignone completed chemotherapy more than a year ago but also has endured radiation to treat a tumor on his neck, and continues to suffer debilitation, according to the court filing seeking trial preference.

Stories of suffering

There are many stories of suffering within the files of the plaintiffs who are still hoping to get their day in court against Monsanto.

  • Retired FBI agent and college professor John Schafer began using Roundup in 1985 and used the herbicide multiple times during spring, fall and summer months until 2017, according to court records. He did not wear protective clothing until warned by a farmer friend in 2015 to wear gloves. He was diagnosed with NHL in 2018.
  • Sixty-three year-old Randall Seidl applied Roundup over 24 years, including regularly spraying the product around his yard in San Antonio, Texas from approximately 2005 to 2010 and then around property in North Carolina until 2014 when he was diagnosed with NHL, according to court records.
  • Robert Karman applied Roundup products beginning in 1980, generally using a hand-held sprayer to treat weeds on a weekly basis roughly 40 weeks a year, according to court records. Karman was diagnosed with NHL in July 2015 after his primary care doctor discovered a lump in his groin. Karman died in December of that year at the age of 77.

Plaintiffs’ attorney Gerald Singleton said Bayer’s only path to putting the Roundup litigation behind it is to put a clear warning label on its herbicide products, alerting users to the risk of cancer.

“That is the only way this thing is going to be over and done,” he said. Until then, he said, “we’re not going to stop taking cases.”

Monsanto’s Campaign Against U.S. Right To Know: Read the Documents

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Update 3.16.21: The Northern California Chapter of the Society for Professional Journalists honored U.S. Right to Know with the James Madison Freedom of Information Awards for our work submitting public records requests to unearth documents showing how Monsanto recruited public university professors to support its PR goals. Concerned that our research would uncover its influence in academic circles, Monsanto “created a public relations campaign to discredit U.S. Right to Know,” the SPJ noted, but we “exposed those efforts, too.” Here are the details.

Internal documents released in August 2019 provide a rare look into the public relations machinery at Monsanto, and how the company tried to contain an investigation by U.S. Right to Know into its relationships with academics and top universities. USRTK, an investigative research group, has made numerous public records requests to taxpayer-funded universities and academics since 2015, leading to revelations about secretive industry collaborations.

The Monsanto documents are posted here and you can read more about the findings of the USRTK investigations here

The documents reveal that Monsanto worried, “USRTK’s plan will impact the entire industry” and has the “potential to be extremely damaging.” So they deployed 11 Monsanto employees, two PR firms, GMO Answers and involved the world’s top pesticide company in plans to discredit the small nonprofit.

Monsanto also adopted a strategy to counter the reporting of Carey Gillam and her investigative book about the company’s herbicide business. Gillam is research director at USRTK. Monsanto had a ‘Carey Gillam Book’ spreadsheet, with more than 20 actions dedicated to opposing her book before its publication. The company even investigated the singer Neil Young. See coverage:

Monsanto’s plan to discredit USRTK: internal documents, key themes 

Monsanto was deeply worried about USRTK executive director Gary Ruskin’s FOIA investigation, and had an elaborate plan to counteract it. 

Monsanto was concerned that the FOIAs would uncover its influence in the regulatory and policy process, payments to academics and their universities, and collaborations with academics in support of industry public relations goals. Monsanto wanted to protect its reputation and “freedom to operate,” and to “position” the investigation as “an attack on scientific integrity and academic freedom.”

  • “USRTK’s plan will impact the entire industry, and we will need to coordinate closely with BIO and CBI/GMOA throughout the planning process and on any eventual responses,” according to Monsanto’s “U.S. Right to Know FOIA Communications Plan” dated July 25, 2019. BIO is the biotech industry trade association and Council for Biotechnology Information/GMO Answers is a marketing program to promote GMOs run by Ketchum PR firm and funded by the largest agrichemical companies – BASF, Bayer (which now owns Monsanto), Corteva (a division of DowDuPont) and Syngenta.

The companies have pitched GMO Answers as a transparency initiative  to answer questions about GMOs with the voices of “independent experts,” however the documents described here, along with a previously released Monsanto PR plan, suggest that Monsanto relies on GMO Answers as a vehicle to push the company’s messaging.

From page 2, “Monsanto Company Confidential … U.S. Right to Know FOIA Communications Plan

  • “Any situation related to this issue has the potential to be extremely damaging, regardless of how benign the information may seem,” according to a GMO Answers Communications Plan in the document (page 23).

  • “*Worst case scenario*”: “Egregious email illustrates what would be the smoking gun of the industry (e.g. email shows expert/company covering up unflattering research or showing GMOs are dangerous/harmful)” (page 26)

  • The plan called for triggering “emergency calls” with the GMO Answers steering committee if the reach/escalation were serious enough. (page 23)
  • In some cases, Monsanto employees expected access to documents before U.S. Right to Know, even though USRTK requested the documents through state FOI. For UC Davis requests: “We will have a pre-release view of documents”. (page 3)
  • 11 Monsanto employees from 5 departments; two staffers from the trade group BIO and a staffer from GMO Answers/Ketchum were listed as “key contacts” in the plan (page 4). Two employees from FleishmanHillard were involved in assembling the plan (see agenda email).

Monsanto was also concerned about Carey Gillam’s book and tried to discredit it.

Several of the newly released documents relate to Monsanto’s efforts to counteract the reporting of Carey Gillam and her book that investigates the company’s herbicide business: “Whitewash: The Story of a Weed Killer, Cancer and the Corruption of Science” (Island Press, 2017). Gillam is a former reporter for Reuters and current research director of U.S. Right to Know.

The documents include Monsanto’s  20-page “Issues Management / Communication Strategy” for Gillam’s book, with eight Monsanto staffers assigned to preparing for the October 2017 release of Gillam’s book. The strategy was to “minimize media coverage and publicity of this book this summer/fall by pointing to “truths” regarding farming …” 

An Excel spreadsheet titled “Project Spruce: Carey Gillam Book” describes 20 action items, with plans including paid placement for a post to appear on Google with a search for “Monsanto glyphosate Carey Gillam,” generating negative book reviews, and plans to “engage regulatory authorities” and “Pro-Science Third Parties,” including Sense About Science, Science Media Centre, the Global Farmer Network and the “Campaign for Accuracy in Public Health Research,” a project of the American Chemistry Council.

The documents reveal the existence of the Monsanto Corporate Engagement Fusion Center. 

Monsanto planned to “Work with the Fusion Center to monitor USRTK digital properties, the volume and sentiment related to USRTK/FOIA, as well as audience engagement.” (page 9) For more about corporate fusion centers, see:

Monsanto makes frequent references to working with third parties to counteract USRTK

Others mentioned in the plans included:

Newly released documents list

Monsanto’s campaign to counteract the U.S. Right to Know public records investigation

Monsanto U.S. Right to Know FOIA Communications Plan 2019
July 25, 2019: Monsanto’s 31-page strategy plan to counteract the FOIA investigation. “USRTK’s plan will impact the entire industry…. Any situation related to this issue has the potential to be extremely damaging…”

Monsanto USRTK FOIA meeting agenda
May 15, 2016: Agenda for a meeting to discuss the USRTK FOIAs with eight Monsanto and two FTI Consulting employees.

Monsanto Comprehensive USRTK FOIA Preparedness and Reactive Plan 2016
May 15, 2016: Earlier draft of the Monsanto strategy to deal with the FOIAs (35 pages).

Monsanto response to FOIA article
February 1, 2016: Monsanto employees crafted a communications plan to provide a “10,000 foot view” of how Monsanto works with public sector scientists and/or provides funding to public sector programs – but not details about which universities they fund or how much. The plan responded to an article Carey Gillam wrote for USRTK, based on documents obtained by FOIA, reporting on undisclosed Monsanto funding to University of Illinois Professor Bruce Chassy.

Unfortunate language AgBioChatter Biofortified boys

  • September 2015: Discussion about “unfortunate” language used by an industry representative to communicate with academics and whether AgBioChatter, a list serve of academics and industry reps, was private or confidential. Karl Haro von Mogel of the GMO promotion group Biofortified advised AgBioChatter members to take “the Ruskin Cleanse” of their private emails to prevent damaging disclosures via FOIA.
  • Bruce Chassy shared with the AgBioChatter list his responses to a fact checker for Mother Jones (“I plan to respond without providing the requested information”) and his correspondence with Carey Gillam in response to her queries for Reuters about his industry ties.

Monsanto’s plans to discredit Carey Gillam’s Book

“Monsanto Company Confidential Issues Management / Communication Strategy” for Carey Gillam’s Book (October 2017)

“Project Spruce: Carey Gillam Book” Excel spreadsheet with 20 action items (September 11, 2017)

Monsanto and FTI Consulting employees discuss the Gillam action plan (September 11, 2017)

Monsanto video prep plans for Gillam book

Monsanto push back on Reuters editors
October 1, 2015: Email from Monsanto’s Sam Murphey: “We continue to push back on her editors very strongly every chance we get. And we all hope for the day she gets reassigned.”

Roundup “Reputation Management”

Reputation Management for Roundup 2014
February 2014: “L&G Reputation Management Sessions Summary, Lyon Feb. 2014” Power Point, with slides that describe what “we want to be known for / we want to avoid being linked with,” and what’s needed to win the argument about glyphosate safety.  “Question… are we just managing and delaying decline (like tobacco)?”

Roundup reputation management slide 2014:

Background on U.S. Right to Know investigations

U.S. Right to Know is a non-profit investigative research group focused on the food industry. Since 2015, we have obtained hundreds of thousands of pages of corporate and regulatory documents via Freedom of Information Act (FOIA), U.S. state and international public records requests, and whistleblowers. These documents shine light on how food and agrichemical companies work behind the scenes with publicly funded academics and universities, front groups, regulatory agencies and other third party allies to promote their products and lobby for deregulation.

News coverage based on documents from USRTK Co-director Gary Ruskin’s investigation of the agrichemical industry:

    • New York Times: Food Industry Enlisted Academics in G.M.O. Lobbying War, Emails Show, by Eric Lipton
    • Boston Globe: Harvard Professor Failed to Disclose Connection, by Laura Krantz
    • The Guardian: UN/WHO Panel in Conflict of Interest Row over Glyphosate Cancer Risk, by Arthur Neslen
    • CBC: University of Saskatchewan Prof Under Fire for Monsanto Ties, by Jason Warick
    • CBC: U of S Defends Prof’s Monsanto Ties, But Some Faculty Disagree, by Jason Warick
    • Mother Jones: These Emails Show Monsanto Leaning on Professors to Fight the GMO PR War, by Tom Philpott
    • Global News: Documents Reveal Canadian Teenager Target of GMO Lobby, by Allison Vuchnich
    • Le Monde: La discrète influence de Monsanto, by Stéphane Foucart.
    • The Progressive: Flacking for GMOs: How the Biotech Industry Cultivates Positive Media — and Discourages Criticism, by Paul Thacker
    • Freedom of the Press Foundation: How corporations suppress disclosure of public records about themselves, by Camille Fassett
    • WBEZ: Why Didn’t an Illinois Professor Have to Disclose GMO Funding?, by Monica Eng
    • Saskatoon Star Phoenix: Group Questions U of S Prof’s Monsanto Link, by Jason Warick

For more information about the U.S. Right to Know documents, see our investigations page, examples of global news coverage and academic papers based on the documents. Many of the documents are posted in the free, searchable UCSF Industry Documents Library.

Donate to USRTK to help us expand our investigations and keep bringing you this crucial information about our food system. USRTK.org/donate