New analysis of glyphosate industry studies finds them outdated, flawed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The resulting analysis was released July 2, 2021 and concluded that the bulk of the industry studies were outdated and did not meet current guidelines.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.

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

Bayer’s class action settlement plan draws widespread outrage, opposition

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(Updated March 10 to include judge’s order delaying hearing until May 12)

More than 90 law firms and more than 160 lawyers have notified a federal court judge overseeing U.S. Roundup litigation that they oppose Monsanto owner Bayer AG’s $2 billion plan to settle future claims the company expects to be brought by people diagnosed with cancer they blame on use of Monsanto’s herbicide products.

In recent days, nine separate objections to the plan and four amicus briefs have been filed with the U.S. District Court for the Northern District of California, letting Judge Vince Chhabria know the extent of opposition to the proposed class settlement. Chhabria has been overseeing thousands of Roundup cancer lawsuits in what is called ‘multidistrict litigation’ (MDL).

On Monday, the National Trial Lawyers (NTL) joined in the opposition on behalf of its 14,000 members. The group said in their filing with the court that they agree with the opposition that “the proposed settlement seriously endangers access to justice for millions of people in the proposed class, would prevent Monsanto’s victims from holding it accountable, and would reward Monsanto in numerous respects.”

The group reiterated in its filing the fear that if Bayer’s proposed settlement is approved, it will set a dangerous precedent for plaintiffs in future, unrelated cases: “It will hurt the proposed class members, not help them. This type of settlement would also provide an untenable template for other corporate tortfeasors to avoid appropriate liability and consequences for their conduct… the proposed class settlement is not how a ‘system of justice’ works and thus such a settlement should never be approved.”

The $2 billion proposed settlement is aimed at future cases and is separate from the $11 billion Bayer has earmarked to settle existing claims brought by people alleging they developed non-Hodgkin lymphoma (NHL) due to exposure to Monsanto’s weed killers. The people impacted by the class settlement proposal are individuals who have been exposed to Roundup products and either already have NHL or may develop NHL in the future, but who have not yet taken steps to file a lawsuit.

No punitive damages

One of the key problems with the Bayer plan, according to critics, is that everyone in the United States who meets the criteria as a potential plaintiff will automatically become part of the class and subject to its provisions if they do not actively opt out of the class within 150 days after Bayer issues notifications of the formation of the class. The notification proposed is not sufficient, the critics say. Moreover, the plan then strips those people – who may not even choose to be a part of the class – from the right to seek punitive damages if they do file a lawsuit.

Another provision garnering criticism is a proposed four-year “standstill” period blocking the filing of new lawsuits.

The critics also object to the proposed formation of a science panel that would act as a “guidepost” for an “extension of compensation options into the future” and to provide evidence about the carcinogenicity – or not – of Bayer’s herbicides.

The initial settlement period would run for at least four years and could be extended after that period.  If Bayer elects not to continue the compensation fund after the initial settlement period, it will pay an additional $200 million as an “end payment” into the compensation fund, the settlement summary states.

Struggling for a solution

Bayer has been struggling to figure out how to put an end to the Roundup cancer litigation since buying Monsanto in 2018. The company lost all three trials held to date and lost the early rounds of appeals seeking to overturn the trial losses.

Juries in each of the three trials found not only that Monsanto’s glyphosate-based herbicides such as Roundup cause cancer, but also that Monsanto spent decades hiding the risks.

The small group of lawyers who put the plan together with Bayer say it will “save lives” and will provide “substantial benefits” to people who believe they developed cancer from exposure to the company’s herbicide products.

But that group of lawyers stands to receive $170 million for their work with Bayer to implement the proposed plan, a fact critics say taints their involvement and objectivity. None of the lawyers involved in putting the class action plan together with Bayer actively represented any plaintiffs in the broad Roundup litigation before this point, the critics point out.

In one of the opposition filings, lawyers seeking a rejection of the proposed settlement wrote this:

“This proposed settlement is opposed by those most familiar with the litigation of cases involving dangerous products like Roundup because they recognize that this proposal would benefit Monsanto and class counsel at the expense of the millions of people exposed to Roundup.

“Although this Roundup MDL has been underway for over four years, and other Roundup cases have been litigated in state courts, the impetus for this engineered class action settlement does not come from lawyers who have been handling Roundup cases and believe that an alternative method for resolving them is essential. Instead, the lawyers who are behind this settlement – and it is surely the lawyers and not Roundup victims – are class-action lawyers who seek to impose their views on all those who have been exposed to Roundup, in exchange for a very large fee.

“But an even bigger winner here will be Monsanto, which will get a four-year stay of litigation by class members, who will also lose their right to seek punitive damages and be saddled with the results of an ill-conceived science panel. In exchange, class members will be shunted into an alternate compensation system that features modest payments, increased complexity, and high hurdles to qualify.”

Delay sought

Bayer’s settlement plan was filed with the court on Feb. 3, and must be approved by Judge Chhabria in order to become effective. A prior settlement plan submitted last year was scorned by Chhabria and then withdrawn.

A hearing on the matter was set for March 31 but the attorneys who put the plan together with Bayer have asked Judge Chhabria to delay the hearing until May 13, citing the breadth of the opposition they must address. The judge responded with an order resetting the hearing for May 12.

“These filings totaled more than 300 pages, in addition to more than 400 pages of attached declarations and exhibits,” the lawyers said their request for more time. “The objections and amicus briefs raise a host of issues, including, among other things, the overall fairness of the settlement, multiple constitutional attacks on the settlement and proposed advisory science panel, technical challenges to the notice program, attacks on the fairness of the compensation fund, and challenges to predominance, superiority, and the adequacy of class (and subclass) counsel.”

The lawyers who filed the proposed plan said they could use the additional time before the hearing “to engage with objectors” to “streamline or narrow the issues that need to be contested at the hearing.”

Deaths continue

Amid the arguments over Bayer’s proposed settlement, plaintiffs continue to die. In what is referred to as a “Suggestion of Death,” lawyers for plaintiff Carolina Garces filed a notification with the federal court on March 8 that their client had died.

Several plaintiffs suffering from non-Hodgkin lymphoma have died since the start of the litigation in 2015.