New analysis of glyphosate industry studies finds them outdated, flawed

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

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

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

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

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

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

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

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

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

The resulting analysis was released July 2, 2021 and concluded that the bulk of the industry studies were outdated and did not meet current guidelines.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

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

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

Regulatory renewal sought

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

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

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

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

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

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

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

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

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

Once-secret studies

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

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

European Assessment Group on Glyphosate report on glyphosate renewal

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

Comments concerning the mutagenic/genotoxic properties of glyphosate

Toxicological and Metabolism Studies summary by industry

Albaugh 2014 glyphosate reverse mutation assay Switzerland

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

Dow Chemical 2012 Micronucleus test of glyphosate TGAI in mice

Industrias Afrasa 2012 reverse mutation with glyphosate

Helm 2010 Reverse Mutation Assay glyphosate using bacteria

Helm 2010 reverse mutation assay 

Helm 2010 mutagenicity of glyphosate testing

Helm 2009 mutagenicity study of glyphosate Germany

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

Syngenta 2009 glyphosate reverse mutation

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

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

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

Helm 2007 Mammalian erythrocyte micronucleus test for glyphosate

Helm Do Brasil 2007 Bacterial reverse mutation test glyphosate

Nufarm 2007 reverse mutation glyphosate technical 05068

Nufarm 2007 1061403 reverse mutation glyphosate technical 05067

Nufarm 2007 1061402 reverse mutation glyphosate technical 05070 

Nufarm 2005 glyphosate technical micronucleus test in the mouse

Monsanto 1998 Mouse micronucleus screening assay of MON-0818

Zeneca Glyphosate 1998 acid Invitro 

Cheminova 1996 reverse mutation glyphosate Brazil

Cheminova 1996 A micronucleus study in mice for the product GILFOS

Zeneca 1996 glyphosate mutagenicity potential

Zeneca 1996 Glyphosate acid mouse bone marrow micronucleus test

Zeneca 1996 glyphosate acid mouse lymphoma gene mutation assay

Sanko 1995 glyphosate in vitro cytogenetics

Sanko 1995 glyphosate DNA Repair Test

Sankyo 1995 reverse mutation study 

Mastra and Maruzen Kako 1995 Technical glyphosate

Mastra and Maruzen Kako 1995 reverse mutation assay glyphosate

Agrichem 1995 Evaluation of ability of glyphosate to induce chromosome aberrations

Feinchemie Schwebda 1994 DNA repair test with primary rat hepatocytes

Feinchemie Schwebda 1994 in vivo mammalian bone marrow cytogenetic test

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

Feinchemie Schwebda 1992 Dominant lethal test in Wistar rats

Monsanto 1992 Mouse micronucleus study of Roundup

Monsanto 1992 glyphosate mutagenicity assay on Roundup

Monsanto 1992 Mouse micronucleus study of RODEO glyphosate formulation

Monsanto 1992 glyphosate mutagenicity assay on RODEO herbicide

Monsanto 1992 mouse micronucleus study of DIRECT formulation

Monsanto 1992 glyphosate mutagenicity potential DIRECT brand

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

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

Cheminova 1991 #12323 glyphosate mutagenicity test

Cheminova 1991 #12324 Mutagenicity test micronucleus glyphosate

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

Monsanto 1990 Ames Salmonella mutagenicity assay of MON 0818

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

Monsanto 1983 glyphosate gene mutation assay

Monsanto 1981 Ames salmonella mutagenicity assay of MON 8080

Monsanto 1980 Dominant lethal mutagenicity assay with technical glyphosate in mice

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

The Dicamba Papers: Key Documents and Analysis

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

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

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

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

Federal Action

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

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

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

Background

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

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

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

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

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

“Environmental catastrophe” in Nebraska tied to pesticide-contaminating plant; See regulatory docs on AltEn neonicotinoid problems

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(Updated June 10 with state regulatory announcement about seed company clean-up efforts.)

An “environmental catastrophe” unfolding in Nebraska is drawing scrutiny from around the United States and sparking questions about why regulators were unwilling or unable to rein in years of questionable activities by the company known as AltEn LLC.

AltEn has been operating an ethanol plant in Mead, Nebraska, and advertising the plant site as a disposal facility for seeds coated in an array of pesticides known to be dangerous to humans and wildlife.

It has become a common practice by large seed companies such as Monsanto-owner Bayer AG, Syngenta, Corteva and others to sell seeds for growing corn, soy, wheat and other crops that are coated with neonicotinoids and other chemicals designed to help the plants fight off insects and disease.

Disposing of unwanted supplies of these treated seeds can be costly and complicated, so AltEn’s eagerness to take in the coated seed was welcomed by the seed companies.  The companies say they believed AltEn would properly use and/or dispose of the seeds and they were not aware of a contamination threat.

But the concentration of pesticide-coated seeds being taken in at the AltEn site left the plant’s wastewater and byproducts such as distillers grains contaminated with an pesticides at levels much higher than what is considered safe.

Now the area’s water and soil is showing evidence of contamination.

Carol Blood, a Nebraska state senator, calls the situation an “environmental catastrophe.”  Fish die-offs have been reported miles downstream from the plant and university researchers have reported the decimation of dozens of honeybee colonies, while state officials have received reports of sick and dying geese and other birds.

See this May 29, 2021 story in the Guardian.

As reported in the Guardian, the contamination has been ongoing for years. There have been accidental spills and leaks of the plant’s pesticide-laden waste, which has been stored in poorly maintained lagoons and piled into hills of a putrid lime-green mash called “wet cake.” The company had also distributed the waste to area farmers for spreading across fields as “soil conditioner.”

It was only earlier this year – after the Guardian exposed the problems – that state officials ordered the plant to close, and began clean-up efforts. In February, roughly  a month after the revelations about the dangers of the AltEn plant’s practice of using pesticide-treated seeds, Nebraska state regulators ordered the plant closed.  

The Nebraska Attorney General’s office sued the company in March, alleging multiple violations of environmental regulations and said there is an “ongoing threat to the environment,” because of AltEn’s actions.

Nebraska lawmakers also have now passed a bill restricting the use of pesticide-treated seeds for ethanol production.

And researchers from the University of Nebraska and from Creighton University are launching a 10-year study of the impacts of the AltEn contamination on human and environmental health.

On June 10, 2021, the state announced that a coalition of seed companies – calling themselves the AltEn Facility Response Group – has formally asked the state to allow them develop and help implement short- and long-term remediation plans for the environmental cleanup.

The concerns in Mead are but the latest example of growing global fear about the impacts of neonicotinoids.

See here some of the regulatory documents related to the controversy as well as other background materials:

May 20, 2021 Bayer to NDEE email re pipe leak

May 20, 2021 seed company letter to NDEE re cattle facility sale

May 18, 2021 Bayer email with NDEE over pipe leak report

May 17, 2021 memorandum with aerial photos of AltEn site

May 14, 2021, NDEE approves Bayer request on AltEn water movement 

May 7, 2021 letter regarding pond pesticide sampling concerns

April 8 letter regarding soil sampling at Mead City Park

March 31, 2021 pond sampling results letter

Feb 14, 2021  inspection report of leak

Jan 13, 2021 EPA OPP letter to NDEE regarding pesticides in ethanol wastewater lagoons

Nov. 17, 2020, EPA OPP letter to NDEE regarding pesticides in AltEn wet cake 

Analysis of wetcake distillers grains

Wastewater analysis 

April 2018 citizen complaint

State response to April 2018 complaints

May 2018 state response to complaints

AltEn Stop use & sell letter June 2019

State letter denying permits and discussing problems

May 2018 list of farmers where they spread the waste

July 2018 discussion of wetcake being treated seed

Sept 2020 letter re spills with photos

October 2020 letter of noncompliance

February 2013 permit application from AltEn

Aerial Photos of site taken by state

How Neonicotinoids Can Kill Bees

Trends in neonicotinoid pesticide residues in food and water in the United States, 1999-2015

Letter from health experts to EPA warning on neonicotinoids

Letter from Endocrine Society to EPA on neonicotinoids 

Neonicotinoid pesticides can stay in the U.S. market, EPA says

Petition to California to regulate neonic-treated seeds

Vanishing Bees: Science, Politics and Honeybee Health (Rutgers University Press, 2017)

See photos below taken by Nebraska state investigators in May 2021 and provided to US Right to Know.

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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.

Bill Gates’ radical menu for food systems: ultra-processed foods, patents, monocrops

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By Stacy Malkan

If Bill Gates has his way, the food in our future will little resemble what’s on our plates today. Gates and his agribusiness industry partners are proposing to transform our food and how it is produced. 

To the techno-food industrialists, hunger and climate change are problems to be solved with data and engineering. The core ingredients of their revolutionary plan: genetic engineering — and patenting — of everything from seeds and food animals, to microbes in the soil, to the processes we use to make food. Local food cultures and traditional diets could fade away as food production moves indoors to labs that cultivate fake meat and ultra-processed foods. 

Gates says rich countries should shift entirely to synthetic beef. And he has the intellectual property rights to sell them. As a food that can help fix the climate, Gates touts the Impossible Burger, a plant-based patty made from genetically engineered soy and textured with engineered yeast. Its manufacturer, the Gates-funded Impossible Foods, has two dozen patents and more than 100 patents pending to artificially replicate cheese, beef and chicken and permeate these products with manufactured flavors, scents and textures.

Ginkgo Bioworks, a Gates-backed start-up that makes “custom organisms,” just went public in a $17.5 billion deal. The company uses its “cell programming” technology to genetically engineer flavors and scents into commercial strains of engineered yeast and bacteria to create “natural” ingredients, including vitamins, amino acids, enzymes and flavors for ultra-processed foods.

According to its investor presentation, Ginkgo plans to create up to 20,000 engineered “cell programs” (it now has five) for food products and many other uses. Axios reports that the company plans to charge customers to use its “biological platform” like Amazon charges for its data center, and will take royalties like apps in the Apple Store. Ginkgo’s customers, the investor pitch makes clear, are not consumers or farmers, but rather the world’s largest chemical, food and pharmaceutical companies.

If techno-food products are not high on most consumers’ shopping lists, this is a menu investors can get behind. The market for genetically engineered products has the potential to reach $2-4 trillion in the next 20 years. And Bill and Melinda Gates are positioned to reap the rewards. The Gates back “a multitude of agrifood tech startups,” reports AgFunder News, either through private investment vehicles or through the Gates Foundation Trust, which funds the foundation’s charitable activities.

Gates and the tech start-ups pitch their products as solutions for our most challenging environmental and social issues. But are they really?

Doubling down on monocultures 

Gates’ “winning strategy for food and farming,” according to a recent Fortune magazine article by Shawn Tully, “is finding ways for farmers to produce more corn and soybeans on every acre … while substantially lowering carbon emissions.” Gates believes that “genetically modified seeds and chemical herbicides, in the right doses – and not land-intensive organic farming – are crucial to curbing carbon emissions.”

Since 2006, the Bill & Melinda Gates Foundation has spent over $5 billion on efforts to transform African agriculture; its flagship program, the Alliance for a Green Revolution in Africa, works to transition farmers to high-input industrial agriculture and scale up markets for commercial seeds and agrichemicals. Gates says these methods can boost production and lift farmers out of poverty.

Many critics, including African faith leaders and hundreds of civil society groups around the world, say the foundation’s agricultural development strategies are failing to deliver on promises and benefitting multinational corporations over small farmers and communities in Africa. The foundation did not respond to our requests for comment.

“Gates has influenced the direction of agriculture to benefit the corporates,” said Million Belay, coordinator of Alliance for Food Sovereignty in Africa (AFSA), a coalition of 50 Africa-based groups. “His foundation has contributed hugely in weakening our seed, biosafety and agrochemical related regulations … it will take years to undo what they have done.”

Gates also influences how governments and academic institutions think about the future of agriculture in Africa, Belay said. “The narrative now is you need to use agrichemicals, high-yield varieties, GMOs and a host of other farm management techniques to feed yourself,” he said. “It will also take years to convince our elites the future is agroecology. As one of the most rich and powerful people on the planet, the doors of our governments are open (to Gates) while it is ajar for African citizens. He has to be called out and has to change direction.”

Leading experts in food security and nutrition are calling for a paradigm shift away from green revolution-style industrial agriculture and toward agroecology, which promotes biodiversity instead of monocultures, integrates animals to rebuild soils, and advocates for political and economic reforms to address inequities and social divisions. Diversified agroecological systems are more resilient, they say, and have a greater capacity to recover from disturbances including extreme weather events, pests and disease.  

Recent science suggests that chemical-intensive industrial agriculture is a key driver of climate change, soil erosion and the worldwide decline of insects. Corn and soy monocultures are especially problematic; they deplete the soil and rely on synthetic fertilizers that emit nitrous oxide, a greenhouse gas 300 times more powerful than carbon dioxide at warming the atmosphere. These are problems Bill Gates is hoping technology can fix. 

A climate solution?

Fortune describes Gates’ plans to intensify corn and soy production as a “pivotal campaign in the war against global warming.” How so? Syngenta, the world’s second largest agrichemical company, is “deploying big data, gene editing, DNA analysis, and other groundbreaking technologies in pursuit of growing bumper harvests while lowering CO2.” Bayer, the leading chemical and seed firm, is making a similar pitch, and claims its new sustainability technologies will “empower 100 million smallholder farmers around the world.”

For 30 years, agrichemical companies promised GMOs could feed the poor and help small farmers, but it hasn’t yet worked out that way. Most GMO crops in the ground today are engineered to survive weed-killing chemicals or kill insects. While these crops provided short-term benefits to farmers, they provided no benefits to consumers, nor did they deliver on promises to boost yields, but they did increase herbicide use. Evidence now indicates the crops are failing as weeds and bugs evolve around the technology.

As a solution to meet the climate crisis, and enable “sustainable intensification” of industrial agriculture, Gates and Bayer point to experimental projects to genetically engineer microbes to fix nitrogen to plants. “If these approaches work,” Gates writes in his climate book, “they’ll dramatically reduce the need for fertilizer and all the emissions it’s responsible for.” In 2017, Ginkgo Bioworks teamed up with Bayer to launch JoynBio, a microbe company that is working to create self-fertilizing plants.

This, too, is a promise Bayer has made before. As far back as 1897, Bayer promoted a product that could reportedly assimilate atmospheric nitrogen, according to Mark Finlay, a history professor at Armstrong Atlantic State University. Bayer said its product could “conceivably make all agricultural lands permanently fertile,” Finlay wrote in a 2015 book about the history of agriculture. “Although early results were disappointing, many popular press writers hailed the potential of this discovery.” 

GMO 2.0: genome-editing 

Gates is an evangelist for genetically engineered foods. He predicts that “GMOs will end starvation in Africa” and GMOs can “end world hunger by 2030.” If the first generation of GMO crops failed to deliver on these hopes, Gates believes new genetic engineering methods will get us there.  

With CRISPR-Cas9 and other “genome-editing” techniques, scientists can now add or delete strands of DNA, or turn genes on or off, to produce specific traits in plants or animals — as if writing computer code. Examples include mushrooms that are “edited” to resist browning, “terminator cattle” bred to father only male offspring, or harmless strains of E Coli converted to antioxidant factories

Gene-editing techniques, and especially CRISPR, are efficient but unpredictable. Studies show the CRISPR process can create unexpected mutations including DNA damage and other off-target effectsIn 2019, a plan to release CRISPR-edited “hornless cows” to Brazil was scrapped after a U.S. government researcher discovered the cattle had two antibiotic-resistance genes that weren’t supposed to be there. The Recombinetics, Inc. cows were the “poster animals of the gene-editing revolution,” according to MIT Technology Review, until the “major screw-up in their DNA” came to light. The company’s researchers missed the extra DNA in their own studies; they reported, incorrectly, that the animals were “free of off-target effects.” 

Genetic engineering, including genome-editing, “has unpredictable outcomes,” says Michael Antoniou, a molecular geneticist at King’s College in London. “You don’t know in advance what the consequences are of the GM transformation process … and because you don’t know, the only way to evaluate safety is generically,” Antoiniou said. “You basically need to conduct a long term feeding trial in animals and see what happens …  and that’s just not going on anywhere in the world for regulatory purposes, at all.”

Nevertheless, experiments continue on important crops and food animals. Gates Foundation has spent over $40 million on projects to genetically engineer dairy cows, with hopes of creating the “perfect” cow. Acceligen (a division of Recombinetics) is working with a Gates Foundation grant to engineer multiple traits into dairy cows to maximize productivity and durability in hot climates.

The foundation is also a leading funder of gene drive experiments that can force an engineered trait through a species. This month in the Florida Keys, the Gates Foundation-backed company Oxitec released 144,000 mosquitos engineered to eliminate females in a disease-carrying species. Proposed agricultural uses for gene drives include reversing herbicide tolerance in plants, suppressing weeds and eradicating agricultural pestsWhat could possibly go wrong? 

Systemic risk 

One of the world’s foremost experts on probability and uncertainty, Nassim Taleb, considered that question — What could go wrong with GMOs? — for a 2014 paper he wrote with colleagues at the New York University School of Engineering. The authors analyzed GMOs in the context of what they called a “non-naive” view of the Precautionary Principle. They concluded: “GMOs represent a public risk of global harm” and should be subject to “severe limits.”  

The Precautionary Principle states that if an action has a suspected risk of causing severe harm to the public domain, the action should not be taken in the absence of scientific near-certainty about its safety. The authors believe it “should be evoked only in extreme situations” when the potential harm is systemic and the consequences widespread and irreversible; they said GMOs “fall squarely” within this criteria. 

Among the systemic risks they cited: GMOs have the propensity to spread uncontrollably, with irreversible system-wide effects and unknown downsides. The ecological impacts are not tested empirically — and therefore not understood — before the technologies are released. The researchers noted two factors that contribute to systemic risk: the engineered genetic modifications and the monocultures in which they grow.

“Instead of a long history of evolutionary selection, these modifications rely not just on naive engineering strategies that do not appropriately consider risk in complex environments, but also explicitly reductionist approaches that ignore unintended consequences,” the researchers said. “Labeling the GMO approach “scientific” betrays a very poor—indeed warped—understanding of probabilistic payoffs and risk management.”

Taleb summed up their conclusions in a 2015 New York Times op-ed: “The GMO experiment, carried out in real time and with our entire food and ecological system as its laboratory, is perhaps the greatest case of human hubris ever. It creates yet another systemic, ‘too big too fail’ enterprise — but one for which no bailouts will be possible when it fails.”

Ginkgo Bioworks investor pitch

Monopoly Bill 

If Gates’ plans for the food system make little sense from an equity or ecological perspective, they are logical from the point of view of an economic monopolist. 

As the former CEO and largest shareholder of Microsoft, you might think that Bill Gates is a capitalist, but that’s not exactly the case,” Megan Tompkins-Stange, a scholar of philanthropy at University of Michigan, told The Ink. “Gates’ version of capitalism would better be called monopolistic. He has consistently sought to distort free markets in order to advance his own corporation’s accumulation of wealth, power, and preeminence.”

These ideologies led to the recent controversy over Covid-19 vaccines, in which Gates’ insistence on patents may have impeded vaccine access for the world’s poor. The incident raised concerns about the powerful influence Gates wields over vital issues involving public health. As Timothy Schwab wrote in The Nation,“It is increasingly urgent to ask if Gates’s multiple roles in the pandemic — as a charity, a business, an investor, and a lobbyist — are about philanthropy and giving away money, or about taking control and exercising power — monopoly power.” 

Gates is playing all the same roles in our food system. “Gates has placed his investment bets in many of the key places in this emerging corporate narrative about what the food system needs: gene drives, geoengineering, fake meat, digital agriculture, carbon sequestration,” says Jim Thomas from the ETC Group, which investigates corporate concentration in the food industry. “Clearly he is set to benefit from these changes, plus his Foundation funding supports all this.”

Agribusiness companies are deploying digital apps on farms around the world to gather data on all aspects of farming: soil health, product inputs, weather, cropping patterns and more, including genetic information on the world’s most important seeds and livestock and knowledge indigenous farmers have developed over thousands of years. All this data to be owned and controlled by corporations, run through AI algorithms, and sold back to farmers with “prescriptions” for how to farm and which corporate products to buy, with little transparency or explanation.

The hyper-consolidated food and agriculture system has already brought numerous negative consequences to farmers and consumers. A 2019 report by the International Panel of Experts on Sustainable Food Systems documents how corporate concentration has squeezed farmer incomes, eroded their choices, narrowed the scope of innovation and escalated public health and environmental risks. The corporate drive to control Big Data, IPES said, “stands to exacerbate existing power imbalances, dependencies, and barriers to entry across the agri-food sector.”

Gates Ag One 

Impatient with the creeping progress of the techno-food revolution, the Gates Foundation last year launched a new tax-exempt nonprofit that “seeks to accelerate the development of innovations supported by the foundation’s Agricultural Development team” in two of the fastest-growing regions in the world: sub-Saharan Africa and South Asia. 

The new “ag tech startup” will “work with partners from the public and private sector to commercialize resilient, yield-enhancing seeds and traits.” It is located in St. Louis, Missouri, former home of Monsanto and current hub of leading chemical and seed firms, and headed up by Joe Cornelius, the former managing director of Agriculture, Food and Nutrition at Bayer CropSciences. As if to underscore that uniformity and centralized control are core goals of the effort, the new nonprofit is called “Gates Ag One.”

Farm of the future?

In 2019, Cargill (a partner of Ginkgo Bioworks) opened a $50 million factory in Lincoln, Nebraska. The plant manufactures EverSweet, a substance that tastes like the sweetener stevia. To produce it, Cargill combines genetically engineered yeast with sugar molecules to mimic the taste of stevia. 

Consumers would not know this by reading the website or looking at the package; the company artfully describes the process as a “centuries-old technique” involving “fermentation.” It markets EverSweet as “non-artificial.”  

Cargill also pitches the product as “sustainably produced,” presumably because it moves stevia production off the land, in places like Paraguay where small farmers have been cultivating stevia for generations. But the feedstock for engineered foods made in Cargill’s new plant has to come from somewhere. Cargill would not tell us what it uses for feedstock, but the factory’s’ location in Nebraska offers a clue: it is surrounded by monocrops of GMO corn and soy.

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Key Court Hearing Wednesday in Bayer Cancer Liability Litigation

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(UPDATED May 18 with pretrial order)

As Bayer AG works to put an end to costly litigation over alleged connections between Roundup herbicide and cancer, the company faces a critical hearing on Wednesday in federal court in San Francisco.

At issue in the hearing is a proposed $2 billion class action settlement structured by Bayer in coordination with a small team of plaintiffs’ lawyers as a means to address potential future lawsuits.

Proponents of the proposed class action plan say it “will save lives,” and provide “speedy compensation” to people who get NHL.

But the plan has generated widespread opposition from law firms around the country who say the proposal actually does little for cancer patients while benefiting Bayer and the lawyers who structured the proposal and who will be paid millions of dollars in fees if the plan goes through.

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 non-Hodgkin lymphoma (NHL) they attribute to their Roundup exposure.

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 U.S. District Judge Vince Chhabria.  A prior class action settlement plan submitted last year was scorned by Chhabria and then withdrawn. The judge has been overseeing the federal multidistrict Roundup litigation involving thousands of plaintiffs from around the United States.

On Tuesday, Judge Chhabria issued a pretrial order stating that Wednesday’s hearing “will focus on big-picture concerns” with the proposed settlement.

Bayer bought Monsanto in 2018 and has been struggling ever since to defend the line of glyphosate-based herbicide products such as Roundup that Bayer inherited in the acquisition. 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 non-Hodgkin lymphoma while Monsanto spent decades hiding the risks.

A “Big Prize”

Likening the class action settlement proposal to a “carnival barker hawking a ‘big prize,’” veteran consumer attorney Gerson Smoger told the court in a recent filing: “This is not merely an unfair deal.  It is a deal designed to allow Monsanto to poison future generations. Monsanto knows it can only do this if it can put shackles on our system of justice. After four attempts, it should be clear that this proposed settlement cannot be remedied. This Court should deny preliminary approval and end this exercise in allowing a corporation to buy its own justice system.”

Smoger is one of more than 160 lawyers from more than 90 law firms who have notified the court they object to the proposed class action settlement, which has been rewritten multiple times already to try to appease objections.

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.

“Importantly, there has never been a release of punitive damages in a class action settlement involving a hazardous product that was still on the market. If this Court approves this Settlement, it would be the first time that has ever happened in the history of American jurisprudence,” the Public Justice brief states.

The critics also object to the proposed formation of a science panel designed to provide evidence about whether or not the company’s glyphosate-based herbicides actually are carcinogenic, a four-year stay of future litigation, and many other components of the plan.

Proponents Cite Plan Benefits

The legal team pushing the class action settlement forward, counters that the plan actually is a good thing for people who may develop NHL in the future.

“This settlement will save lives. It will deliver notice, outreach, and information, including on the product label itself, to Roundup users—among them those overlooked by the tort system to date—that they may be at risk and should take action,” the proponents of the plan said in a court filing.

According to the class action settlement proponents, the plan will

  • Alert potential class members to be evaluated for NHL, and provide them diagnostic assistance to do so through a medical-monitoring program
  • Provide an option for “significant and speedy compensation” if a class member gets NHL
  • Provide access to free legal services
  • Fund research into treatment and diagnosis of NHL.
  • Allow class members the right to sue Monsanto for compensatory damages if the class member prefers

Judge Chhabria said in an order issued May 10 that along with hearing from the proponents of the plan, he will allow oral arguments from all those who have filed objections to the plan in Wednesday’s hearing.

In his pretrial order issued May 18, Chhabria said several questions would need to be addressed. Among the questions posed by the judge are these:

  • Why is it in the interest of the class to agree in advance to the admission in future trials of
    the conclusions of a court-appointed independent science panel, given how well the trials
    have been going for plaintiffs without such a panel?
  • If the Court understands the settlement correctly, it binds anyone exposed to Roundup
    before February 3, 2021 (assuming they do not opt out), but contemplates that the
    compensation fund and medical monitoring program can be terminated a few years after
    the settlement is approved. Why would it be in the interest of people exposed to Roundup
    before February 2021 to bind themselves to a fund and program that expires so quickly?
  • Is it appropriate to certify a class for settlement purposes when it is obvious that the class could never be certified for litigation purposes?

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.”