Bayer’s plan for settling future Roundup cancer claims faces broad opposition

Print Email Share Tweet

Dozens of U.S. law firms have formed a coalition to fight a new $2 billion settlement proposal by Monsanto owner Bayer AG that aims to contain the company’s ongoing liability related to claims that Roundup herbicides cause a type of cancer known as non-Hodgkin lymphoma (NHL).

The settlement is designed to compensate people 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.

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

But many lawyers criticizing the plan say if it is approved it would set a dangerous precedent for other types of litigation involving large numbers of people injured by the products or practices of powerful corporations.

“This is not the direction we want the civil justice system to go,” said attorney Gerald Singleton, whose firm has joined with more than 60 other law firms to oppose Bayer’s plan. “There is no scenario under which this is good for plaintiffs.”

Bayer’s settlement plan was filed with the U.S. District Court for the Northern District of California on Feb. 3, and must be approved by U.S. District Judge Vince Chhabria in order to become effective. A prior settlement plan submitted last year was scorned by Chhabria and then withdrawn.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.

Responses to the settlement plan are due March 3 and a hearing on the matter is set for March 31.

A key concern is that current Roundup users who may develop cancer and want to sue in the future will automatically be subject to terms of the class settlement unless they officially opt out of the settlement within a specific time period. One of the terms they would be subject to would bar them from seeking punitive damages in any future lawsuit.

Those terms and others laid out are wholly unfair to farm workers and others who are expected to develop cancer in the future from exposure to the company’s herbicide products, according to Singleton. The plan benefits Bayer and provides “blood money” to the four law firms that worked with Bayer to design the plan, he said.

Those firms working with Bayer to draft and administer the plan would receive a proposed $170 million if the plan takes effect.

Elizabeth Cabraser, one of the lawyers who crafted the new proposed settlement, said the criticism is not a fair description of the settlement. In truth, she said, the plan “provides significant and urgently-needed outreach, education, healthcare access, and compensation benefits” for people who have been exposed to Monsanto’s Roundup herbicides but have not yet developed non-Hodgkin lymphoma (NHL).

“We seek approval of this settlement because it will save lives and enhance quality of life through early diagnosis, assist people… inform them and raise public awareness about the link between Roundup and NHL…” she said.

A spokesman for Bayer did not respond to a request for comment.

The new proposed settlement is aimed at future cases and is separate from the $11 billion Bayer has earmarked to settle existing U.S. Roundup cancer claims. The people impacted by the class settlement proposal are only individuals who have been exposed to Roundup but are not yet in litigation and have taken no steps toward any litigation.

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 trials found not only that Monsanto’s glyphosate-based herbicides cause cancer but also that Monsanto spent decades hiding the risks.

Though the proposed settlement states that it “addresses the four concerns the Court raised regarding the prior, withdrawn settlement,” Singleton and other lawyers involved in the opposition said the new settlement proposal is just as bad as the first.

In addition to the concerns that class members would not have the right to seek claims for punitive damages, the critics also object to the four-year “standstill” period blocking the filing of new lawsuits. The critics also say the plan for notifying people of the class settlement is not sufficient. Individuals would have 150 days following the notification to “opt out” of the class. If they do not opt out, they are automatically in the class.

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.  Given Monsanto’s documented history of manipulating scientific findings, the science panel work would be suspect, said Singleton.

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.

“Substantial compensation” offered

The law firms that drafted the agreement with Bayer said in their filing to the court that the settlement is structured to provide potential future plaintiffs with “what most serves their interests,” including an option for “substantial compensation” if they develop non-Hodgkin lymphoma.

The plan calls for the establishment of a compensation fund to make awards of between $10,000 and $200,000 per individual class member. “Accelerated Payment Awards” of $5,000 would be available on an expedited basis, requiring just a showing of exposure and diagnosis.

Those people first exposed to Roundup products at least 12 months prior to their diagnosis would be qualified for awards. Awards of  more than $200,000 could be made for “extraordinary circumstances.” Those qualified class members who were diagnosed with NHL before January 1, 2015, would not receive awards more than $10,000, according to the plan. 

The settlement would provide free legal advice and provide ”support to assist class members in navigating, registering, and applying for Settlement benefits.”

Additionally, the proposal states that the settlement will fund medical and scientific research into the diagnosis and treatment of NHL.

Notably, the plan states that no one will lose their right to sue unless they choose to accept compensation from the compensation fund, and no one needs to make that choice until that individual class member is diagnosed with NHL. They would not be able to seek punitive damages but could seek other compensation.

“Any class members who do not file a claim and accept individual compensation retain their right to sue Monsanto for compensatory damages on any legal theory, including personal injury, fraud, misrepresentation, negligence, fraudulent concealment, negligent misrepresentation, breach of warranty, false advertising, and violation of any consumer protection or unfair and deceptive acts or practices statute,” the plan states.

To alert people to the class action settlement, notices would be mailed/emailed to 266,000 farms, businesses and organizations and government entities where the company’s herbicides could have been used as well as to 41,000 people who have non-Hodgkin lymphoma and asked to receive information about their disease. Additionally posters would be mailed to 2,700 stores asking them to post notices of the class action settlement.

As part of the proposed settlement, Bayer said it would seek permission from the Environmental Protection Agency (EPA) to add information on the labels of its glyphosate-based products such as Roundup that would provide links to access to scientific studies and other information about glyphosate safety. But critics say providing a website links is inadequate and Bayer needs to put a straightforward warning of cancer risk on the weed killing products.

The proposed class action settlement threatens to affect “hundreds of thousands or even millions” of people who have been exposed to Roundup and “raises ‘unique’ and profound questions” under the U.S. Constitution, according to a court filing in opposition to the Bayer plan made by plaintiffs’ lawyer Elizabeth Graham.

Graham told the court that if the plan is approved it could have a “dramatic effect not only on this litigation, but on the future of mass tort litigation.”

Black farmers

 The National Black Farmers Association (NBFA) weighed in on the issue on Wednesday, submitting a lengthy filing with Chhabria’s court that states a “substantial proportion” of its more than 100,000 members “have been exposed to and potentially injured by Roundup, and its active ingredient glyphosate.”

Many of the farmers have already developed non-Hodgkin’s lymphoma they blame on Roundup use, and “an even larger proportion fear that they will soon develop symptoms,” the NBFA filing states.

The NBFA wants to see Roundup products removed from commerce or other changes made to protect farmers, the filing states.

The concerns of the NBFA need to be addressed by the court, particularly as Bayer looks to “settle a class action with a set of attorneys who purport to be representing the future interests of all farmers who have been exposed to Roundup but are yet to develop the cancers it causes.”

Lawsuits in Australia

As Bayer works to bring an end to Roundup litigation in the United States, the company is also dealing with similar claims by farmers and others in Australia. A class action filed against Monsanto is underway, and the lead plaintiff John Fenton, who applied Roundup as part of farm work. Fenton was diagnosed with non-Hodgkin lymphoma in 2008.

A series of key dates have been established: Monsanto has until March 1 to provide discovery documents to plaintiffs’ lawyers and June 4 is the deadline set for the exchange of expert evidence.  The parties are to enter into mediation by July 30 and if nothing is resolved the case would go to trial in March 2022.

Fenton said while he would “love the opportunity” to go to trial and tell his story, he hopes mediation will resolve the matter. “I think the consensus is starting to change thanks to what has been happening in the US. Farmers are more aware and I believe they do take more precautions than they used to.

Fenton said he hopes that Bayer ultimately will put a warning label on Monsanto’s glyphosate herbicides.

“At least with a warning the user can make up their own mind about what PPE (personal protective equipment) they choose to wear.”

EPA’s assessments of chemicals draws criticism from its own scientists

Print Email Share Tweet

Many U.S. scientists working for the Environmental Protection Agency (EPA) say they don’t trust the agency’s senior leaders to be honest and they fear retaliation if they were to report a violation of the law, according to a survey of employees conducted in 2020.

According to the Federal Employee Viewpoint Survey for 2020, which was conducted by the U.S. Office of Personnel Management, 75 percent of EPA workers in the National Program Chemicals Division who responded to the survey indicated that they did not think the agency’s senior leadership maintained “high standards of honesty and integrity.” Sixty-five percent of the workers responding from the Risk Assessment Division answered the same way.

Also alarming, 53 percent of respondents in the EPA’s Risk Assessment Division said they could not disclose a suspected violation of the law or regulation without fear of reprisal. Forty-three percent of responding EPA workers in the Office of Pollution Prevention and Toxics (OPPT) answered the same way.

The negative sentiments reflected in the survey results coincide with mounting reports of malfeasance inside EPA’s chemical assessment programs, according to the Public Employees for Environmental Responsibility (PEER).

“It should be of grave concern that more than half the EPA chemists and other specialists working on crucial public health concerns do not feel free to report problems or flag violations,” PEER Executive Director Tim Whitehouse, a former EPA enforcement attorney, said in a statement.

Earlier this month, the National Academies of Sciences, Engineering, and Medicine said the EPA’s hazard assessment practices within the framework of the Toxic Substances Control Act were of “critically low quality.”

“EPA’s new leadership will have its hands full righting this sinking ship,” Whitehouse said.

After taking office in January, President Joe Biden issued an executive order noting that the EPA under Biden may diverge in its position on several chemicals from decisions made by the agency under previous president Donald Trump.

In correspondence dated Jan. 21, the EPA Office of General Counsel said the following:

“In conformance with President Biden’s Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis issued January 20, 2021, (Health and Environment EO), this will confirm my request on behalf of the U.S. Environmental Protection Agency (EPA) that the U.S. Department of Justice (DOJ) seek and obtain abeyances or stays of proceedings in pending litigation seeking judicial review of any EPA regulation promulgated between January 20, 2017, and January 20, 2021, or seeking to establish a deadline for EPA to promulgate a regulation in connection with the subject of any such

Another Roundup study finds links to potential human health problems

Print Email Share Tweet

(Updated February 17, adding criticism of study)

A new scientific paper examining the potential health impacts of Roundup herbicides found links between exposure to the weed killing chemical glyphosate and an increase in a type of amino acid known to be a risk factor for cardiovascular disease.

The researchers made their determinations after exposing pregnant rats and their newborn pups to glyphosate and Roundup through drinking water. They said they looked specifically at the effects of glyphosate-based herbicides (GBH) on urinary metabolites and interactions with the gut microbiome in the animals.

The researchers said they found a significant increase of an amino acid called homocysteine in male rat pups exposed to glyphosate and Roundup.

“Our study provides initial evidence that exposures to commonly used GBH, at a currently acceptable human exposure dose, is capable of modifying urine metabolites in both rat adults and pups,” the researchers stated.

The paper, titled “Low-dose exposure of glyphosate-based herbicides disrupt the urine metabolome and its interaction with gut microbiota,” is authored by five researchers affiliated with the Icahn School of Medicine at Mount Sinai in New York and four from the Ramazzini Institute in Bologna, Italy. It was published in the journal Scientific Reports February 5.

The authors acknowledged many limitations with their study, including a small sample size, but said their work showed that “gestational and early-life low-dose exposure to glyphosate or Roundup significantly altered multiple urine metabolomic biomarkers, in both dams and offspring.”

The study is the first on urinary metabolomic changes induced by glyphosate-based herbicides at doses currently considered safe in humans, the researchers said.

The paper follows the publication last month of a study in the journal Environmental Health Perspectives that found glyphosate and a Roundup product can alter the composition of the gut microbiome in ways that may be linked to adverse health outcomes. Scientists from the Ramazzini Institute were also involved in that research.

Robin Mesnage, one of the authors of the paper published last month in Environmental Health Perspectives, took issue with the validity of the new paper. He said the data analysis showed the differences detected between the animals exposed to glyphosate and those not exposed – the control animals – could have been similarly detected with randomly generated data.

“Overall, the data analysis doesn’t support the conclusion that glyphosate disrupts the urine metabolome and the gut microbiota of the exposed animals,” said Mesnage. “This study will only further confuse a bit more the debate on the toxicity of glyphosate.”

Several recent studies on glyphosate and Roundup have found an array of concerns.

Bayer, which inherited Monsanto’s glyphosate-based herbicide brand and its glyphosate-tolerant genetically engineered seed portfolio when it bought the company in 2018, maintains that an abundance of scientific study over decades confirms that glyphosate does not cause cancer. The U.S. Environmental Protection Agency and many other international regulatory bodies also do not consider glyphosate products to be carcinogenic.

But the World Health Organization’s International Agency for Research on Cancer in 2015 said a review of scientific research found ample evidence that glyphosate is a probable human carcinogen.

Bayer has lost three out of three trials brought by people who blame their cancers on exposure to Monsanto’s herbicides, and Bayer last year said it would pay roughly  $11 billion to settle more than 100,000 similar claims.

 

 

New study finds glyphosate-related alterations in gut microbiome

Print Email Share Tweet

A new animal study by a group of European researchers has found that low levels of the weed killing chemical glyphosate and the glyphosate-based Roundup product can alter the composition of the gut microbiome in ways that may be linked to adverse health outcomes.

The paper, published Wednesday in the journal Environmental Health Perspectives, is authored by 13 researchers, including study lead Dr. Michael Antoniou, head of the Gene Expression and Therapy Group within the Department of Medical and Molecular Genetics at King’s College in London, and Dr. Robin Mesnage, a research associate in computational toxicology within the same group.  Scientists from the Ramazzini Institute in Bologna, Italy, participated in the study as did scientists from France and the Netherlands.

The effects of glyphosate on the gut microbiome were found to be caused by the same mechanism of action by which glyphosate acts to kill weeds and other plants, the researchers said.

The microbes in the human gut include a variety of bacteria and fungi that impact immune functions and other important processes, and a disruption of that system can contribute to a range of diseases, the researchers said.

“Both the glyphosate and the Roundup did have an effect on gut bacterial population composition,” Antoniou said in an interview. “We know that our gut is inhabited by thousands of different types of bacteria and a balance in their composition, and more important in their function, is crucial for our health. So anything that disturbs, negatively disturbs, the gut microbiome… has the potential of causing ill health because we go from balanced functioning that is conducive to health to imbalanced functioning that may lead to a whole spectrum of different diseases.”

See Carey Gillam’s interview Dr. Michael Antonoiu and Dr. Robin Mesnage about their new study looking at glyphosate impact on the gut microbiome.

The authors of the new paper said they determined that, contrary to some assertions by critics of glyphosate use, glyphosate did not act as an antibiotic, killing off necessary bacteria in the gut.

Instead, they found – for the first time, they said – that the pesticide interfered in a potentially worrisome way with the shikimate biochemical pathway of the gut bacteria of the animals used in the experiment. That interference was highlighted by changes in specific substances in the gut. Analysis of  gut and blood biochemistry revealed evidence that the animals were under oxidative stress, a condition associated with DNA damage and cancer.

The researchers said it was not clear if the disturbance within the gut microbiome influenced the metabolic stress.

The indication of oxidative stress was more pronounced in experiments using a glyphosate-based herbicide called Roundup BioFlow, a product of Monsanto owner Bayer AG, the scientists said.

The study authors said they were conducting more studies to try to decipher if the oxidative stress they observed was also damaging DNA, which would raise the risk of cancer.

The authors said more research is needed to truly understand the health implications of glyphosate inhibition of the shikimate pathway and other metabolic disturbances in the gut microbiome and blood but the early findings could be used in the development of bio-markers for epidemiological studies and to understand if glyphosate herbicides can have biological effects in people.

In the study, female rats were given glyphosate and the Roundup product. The doses were delivered through the drinking water provided to the animals and were given at levels representing the acceptable daily intakes considered safe by European and U.S. regulators.

Antoniou said the study results build on other research that makes it clear regulators are relying on outdated methods when determining what constitutes “safe” levels of glyphosate and other pesticides in food and water. Residues of pesticides used in agriculture are commonly found in a range of regularly consumed foods.

“Regulators need to come into the twenty-first century, stop dragging their feet… and embrace the types of analyses that we have done in this study,” Antoniou said. He said molecular profiling, part of a branch of science known as “OMICS,” is revolutionizing the base of knowledge about the impacts chemical exposures have on health.

The rat study is but the latest in a series of scientific experiments aimed at determining if glyphosate and glyphosate-based herbicides – including Roundup – can be harmful to humans, even at levels of exposure regulators assert are safe.

Several such studies have found an array of concerns, including one published in November  by researchers from the University of Turku in Finland who said that they were able to determine, in a “conservative estimate,” that approximately 54 percent of species in the core of the human gut microbiome are “potentially sensitive” to glyphosate.

As researchers increasingly look to understand the human microbiome and the role it plays in our health, questions about potential glyphosate impacts on the gut microbiome have been the subject not only of debate in scientific circles, but also of litigation.

Last year, Bayer agreed to pay $39.5 million to settle claims that Monsanto ran misleading advertisements asserting glyphosate only effected an enzyme in plants and could not similarly impact pets and people. The plaintiffs in the case alleged glyphosate targeted an enzyme found in humans and animals that bolsters the immune system, digestion and brain function.

Bayer, which inherited Monsanto’s glyphosate-based herbicide brand and its glyphosate-tolerant genetically engineered seed portfolio when it bought the company in 2018, maintains that an abundance of scientific study over decades confirms that glyphosate does not cause cancer. The U.S. Environmental Protection Agency and many other international regulatory bodies also do not consider glyphosate products to be carcinogenic.

But the World Health Organization’s International Agency for Research on Cancer in 2015 said a review of scientific research found ample evidence that glyphosate is a probable human carcinogen.

Since that time, Bayer has lost three out of three trials brought by people who blame their cancers on exposure to Monsanto’s herbicides, and Bayer last year said it would pay roughly  $11 billion to settle more than 100,000 similar claims.

New study examines Roundup herbicide impact on honeybees

Print Email Share Tweet

A group of Chinese researchers has found evidence that commercial glyphosate-based herbicide products are harmful to honeybees at or below recommended concentrations.

In a paper published in the online journal Scientific Reports, researchers affiliated with the Chinese Academy of Agricultural Sciences in Beijing and the Chinese Bureau of Landscape and Forestry, said they found a range of negative impacts on honeybees when exposing the bees to Roundup – a glyphosate-based product sold by Monsanto owner Bayer AG.

The memory of the honeybees was “significantly impaired after exposure to Roundup” suggesting that chronic honeybee exposure to the weed killing chemical “may have a negative impact on the search and collection of resources and the coordination of foraging activities” by bees, the researchers said.

As well, the “climbing ability of honeybees significantly decreased after treatment with the recommended concentration of Roundup,” the researchers found.

The researchers said there is a need for a “reliable herbicide spraying early warning system” in rural areas of China because beekeepers in those areas are “usually not informed before herbicides are sprayed” and “frequent poisoning incidents of honeybees” occur.

The production of many important food crops is dependent upon honeybees and wild bees for pollination, and noted declines in bee populations has raised concerns around the world about food security.

A paper out of Rutgers University published last summer warned that “crop yields for apples, cherries and blueberries across the United States are being reduced by a lack of pollinators.”

A death and a settlement as Bayer continues trying to end Roundup litigation

Print Email Share Tweet

Seven months after Bayer AG announced plans for a sweeping settlement of U.S. Roundup cancer litigation, the German owner of Monsanto Co. continues to work to settle tens of thousands of claims brought by people suffering from cancer they say was caused by Monsanto’s weed killing products. On Wednesday, one more case appeared to find closure, though the plaintiff did not live to see it.

Lawyers for Jaime Alvarez Calderon, agreed earlier this week to a settlement offered by Bayer after U.S. District Judge Vince Chhabria on Monday denied summary judgment in favor of Monsanto, allowing the case to move closer to a trial.

The settlement will go to Alvarez’s four sons because their 65-year-old father, a longtime winery worker in Napa County, California, died just over a year ago from non-Hodgkin lymphoma he blamed on his work spraying Roundup around winery property for years.

In a hearing held in federal court Wednesday, Alvarez family lawyer David Diamond told Judge Chhabria that the settlement would close out the case.

After the hearing, Diamond said Alvarez had worked in the wineries for 33 years, using a backpack sprayer to apply Monsanto’s glyphosate-based herbicides to sprawling acreage for the Sutter Home group of wineries. He would often go home in the evenings with clothing wet with herbicide due to leaks in the equipment and weed killer that drifted in the wind.  He was diagnosed in 2014 with non-Hodgkin lymphoma, undergoing multiple rounds of chemotherapy and other treatments before dying in December 2019.

Diamond said he was happy to settle the case but has “400 plus” more Roundup cases still unresolved.

He is not alone. At least half a dozen other U.S. law firms have Roundup plaintiffs they are seeking trial settings for in 2021 and beyond.

Since buying Monsanto in 2018, Bayer has been struggling to figure out how to put an end to the litigation that includes more than 100,000 plaintiffs in the United States. The company lost all three trials held to date and has lost the early rounds of appeals seeking to overturn the trial losses. Juries in each of the trials found that Monsanto’s glyphosate-based herbicides do cause cancer and that Monsanto spent decades hiding the risks.

In addition to efforts to resolve claims currently pending, Bayer also hopes to create a mechanism for resolving potential claims that it could face from Roundup users who develop non-Hodgkin lymphoma in the future. Its initial plan for handling future litigation was rejected by Judge Chhabria and the company has yet to announce a new plan.

Neonicotinoids: a growing concern

Print Email Share Tweet

On January 10, The Guardian published this story about a small rural Nebraska community that has been struggling for at least two years with contamination tied to neonicotinoid-coated corn seed. The source is an area ethanol plant that has been marketing itself as a free “recycling” location for seed companies such as Bayer, Syngenta and others who needed a place to get rid of excess supplies of these pesticide-treated seed stocks. The result, the townspeople say, is a landscape laced with stunningly high levels of neonicotinoid residues, which they say have triggered illnesses in both humans and animals. They fear their land and water are now irreparably contaminated.

State environmental officials have recorded levels of the neonicotinoids at a staggering 427,000 parts per billion (ppb) in testing of one of the large hills of waste on the site of the ethanol plant property. That compares to regulatory benchmarks saying levels must be under 70 ppb to be considered safe.

See this page for more details and documents.

The tale of the toll on the community in Mead, Nebraska, is but the latest sign that state and federal regulatory oversight of neonicotinoids needs to be strengthened, according to environmental advocates and researchers from several U.S. universities.

Most widely used insecticides

The controversy over the class of insecticides known as neonicotinoids, or neonics, has been growing in recent years and has become a global conflict between the corporate behemoths that sell neonics and environmental and consumer groups who say the insecticides are responsible for extensive environmental and human health harm.

Since being introduced in the 1990s, neonicotinoids have become the world’s most widely used class of insecticides, sold in at least 120 countries to help control damaging insects and protect agricultural production. The insecticides are not only sprayed on plants but also coated on seeds. Neonicotinoids are used in producing many types of crops, including rice, cotton, corn, potatoes and soybeans. As of 2014, neonicotinoids represented more than 25 percent of the global pesticide market, according to researchers.

Within the class, clothianidin and imidacloprid are the most commonly used in the United States, according to a 2019 paper published in the journal Environmental Health.

In January 2020, the Environmental Protection Agency released a proposed interim decisions for acetamiprid, clothianidin, dinotefuran, imidacloprid, and thiamethoxam, specific insecticides within the neonicotinoid class. The EPA said it was working to reduce the amount used on crops associated with “potential ecological risks,” restricting when the pesticides could be applied to blooming crops.

Tied to bee deaths

A growing body of scientific evidence indicates that neonicotinoids are a factor in the widespread colony collapse disorder of bees, which are essential pollinators in food production. They are also seen as at least partly to blame for an “insect apocalypse. The insecticides have also been tied to serious defects in white-tailed deer, deepening concerns over the chemical’s potential to harm large mammals, including people.

The European Union banned the outdoor use of neonics clothianidin, imidacloprid and thiamethoxam in 2018, and the United Nations says neonics are so hazardous that they should be “severely” restricted. But in the United States, neonics remain widely used.

Bayer’s bid to settle U.S. Roundup cancer claims making progress

Print Email Share Tweet

Monsanto owner Bayer AG is making progress toward a sweeping settlement of thousands of U.S. lawsuits brought by people alleging they or their loved ones developed cancer after exposure to Monsanto’s Roundup herbicides.

Recent correspondence from plaintiffs’ lawyers to their clients underscored that progress, confirming a large percentage of plaintiffs are opting to participate in the settlement, despite complaints by many plaintiffs that they are facing unfairly small payout proposals.

By some calculations, the average gross settlement will leave little to no compensation, perhaps a few thousand dollars, for individual plaintiffs after attorneys’ fees are paid and certain insured medical costs are reimbursed.

Nevertheless, according to a letter sent to plaintiffs in late November by one of the lead law firms in the litigation, more than 95 percent of the “eligible claimants” decided to participate in the settlement plan negotiated by the firm with Bayer. A “settlement administrator” now has 30 days to review the cases and confirm the plaintiffs’ eligibility to receive settlement funds, according to the correspondence.

People can choose to opt out of the settlement and take their claims to mediation, followed by binding arbitration if they wish or try to find a new lawyer who would take their case to trial. Those plaintiffs could have a difficult time finding a lawyer to help them take their case to trial because the law firms agreeing to the settlements with Bayer have agreed not to try any more cases or assist in future trials.

One plaintiff, who asked not to be identified by name due to the confidentiality of the settlement proceedings, said he is opting out of the settlement in hopes of obtaining more money through mediation or a future trial. He said he requires ongoing tests and treatments for his cancer and the proposed settlement structure would leave him nothing to cover those ongoing costs.

“Bayer wants a release by paying as little as possible without going to trial,” he said.

The rough estimate on average gross payouts per plaintiff is about $165,000, lawyers and plaintiffs involved in the discussions have said.  But some plaintiffs could receive far more, and some less, depending upon the details of their case. There are many criteria determining who can participate in the settlement and how much money that person may receive.

To be eligible, the Roundup user has to be a U.S. citizen, have been diagnosed with non-Hodgkin lymphoma (NHL), and had exposures to Roundup for at least one year prior to being diagnosed with NHL.

The settlement agreement with Bayer will be complete when the administrator confirms that more than 93 percent of claimants qualify, according to the terms of the deal.

If the settlement administrator finds a plaintiff ineligible, that plaintiff has 30 days to appeal the decision.

For plaintiffs deemed eligible the settlement administrator will award each case a number of points based on specific criteria. The amount of money each plaintiff will receive is based on the number of points calculated for their individual situation.

Basis points are established using the age of the individual at the time they were diagnosed with NHL and the level of severity of the “injury” as determined by the degree of treatment and outcome. The levels run 1-5. Someone who died from NHL is assigned basis points for a level 5, for instance. More points are given to younger people who suffered multiple rounds of treatment and/or died.

In addition to the basis points, adjustments are allowed that give more points to plaintiffs who had more exposure to Roundup. There are also allowances for more points for specific types of NHL. Plaintiffs diagnosed with a type of NHL called Primary Central Nervous System (CNS) lymphoma receive a 10 percent boost to their points tally, for example.

People can also have points deducted based on certain factors. Here are a few specific examples from the points matrix established for the Roundup litigation:

  • If a Roundup product user died before January 1, 2009, the total points for the claim brought on their behalf will be reduced by 50 percent.
  • If a deceased plaintiff had no spouse or minor children at the time of their death there is a deduction of 20 percent.
  • If a plaintiff had any prior blood cancers before using Roundup their points are cut by 30 percent.
  • If the span of time between a claimant’s Roundup exposure and the diagnosis of NHL was less than two years the points are cut 20 percent.

The settlement funds should begin to flow to participants in the spring with final payments hopefully made by summer, according to lawyers involved.

Plaintiffs can also apply to be part of an “extraordinary injury fund,” set up for a small group of plaintiffs who suffer from severe NHL-related injuries. A claim may be eligible for the extraordinary injury fund if the individual’s death from NHL came after three or more full courses of chemotherapy and other aggressive treatments.

Since buying Monsanto in 2018, Bayer has been struggling to figure out how to put an end to the litigation that includes more than 100,000 plaintiffs in the United States. The company lost all three trials held to date and has lost the early rounds of appeals seeking to overturn the trial losses. Juries in each of the trials found that Monsanto’s glyphosate-based herbicides, such as Roundup, do cause cancer and that Monsanto spent decades hiding the risks.

The jury awards totaled well over $2 billion, though the judgments have been ordered reduced by trial and appellate court judges.

The company’s efforts to resolve the litigation have been stymied in part by the challenge of how to head off claims that could be brought in the future by people who develop cancer after using the company’s herbicides.

Trial Appeals Continue

Even as Bayer aims to head off future trials with settlement dollars, the company continues to try to overturn the outcomes of the three trials the company lost.

In the first trial loss – the Johnson v. Monsanto case – Bayer lost efforts to overturn the jury finding that Monsanto was liable for Johnson’s cancer at the appellate court level, and in October, the California Supreme Court refused to review the case.

Bayer now has 150 days from that decision to ask for the matter to be taken up by the U.S. Supreme Court. The company has not made a final decision regarding that move, according to a Bayer spokesman, but has indicated previously that it does intend to take such action.

If Bayer does petition the U.S. Supreme Court, Johnson’s attorneys are expected to file a conditional cross-appeal asking the court to examine the judicial actions that slashed Johnson’s jury award from $289 million to $20.5 million.

Other Bayer/Monsanto court cases

In addition to the liability Bayer faces from Monsanto’s Roundup cancer litigation, the company is struggling with Monsanto liabilities in PCB pollution litigation and in litigation over crop damage caused by Monsanto’s dicamba herbicide-based crop system.

A federal judge in Los Angeles last week rejected a proposal by Bayer to pay $648 million to settle class-action litigation brought by claimants alleging contamination from polychlorinated biphenyls, or PCBs, made by the Monsanto.

Also last week, the trial judge in the case of Bader Farms, Inc. v. Monsanto rejected Bayer’s motions for a new trial.  The judge cut the punitive damages awarded by the jury, however, from $250 million to $60 million, leaving intact compensatory damages of $15 million, for a total award of $75 million.

Documents obtained through discovery in the Bader case revealed that Monsanto and chemical giant BASF were aware for years that their plans to introduce a dicamba herbicide-based agricultural seed and chemical system would probably lead to damage on many US farms.

New glyphosate papers point to “urgency” for more research on chemical impact to human health

Print Email Share Tweet

Newly published scientific papers illustrate the ubiquitous nature of the weed killing chemical glyphosate and a need to better understand the impact exposure to the popular pesticide may be having on human health, including the health of the gut microbiome.

In one of the new papers, researchers from the University of Turku in Finland said that they were able to determine, in a “conservative estimate,” that approximately 54 percent of species in the core of the human gut microbiome are “potentially sensitive” to glyphosate. The researchers said they used a new bioinformatics method to make the finding.

With a “large proportion” of bacteria in the gut microbiome susceptible to glyphosate, the intake of glyphosate “may severely affect the composition of the human gut microbiome,” the authors said in their paper, which was published this month in the Journal of Hazardous Materials.

The microbes in the human gut include a variety of bacteria and fungi and are believed to impact immune functions and other important processes. Unhealthy gut microbiomes are believed by some scientists to contribute to a range of diseases.

“Although data on glyphosate residues in human gut systems are still lacking, our results suggest that glyphosate residues decrease bacterial diversity and modulate bacterial species composition in the gut,” the authors said. “We may assume that long-term exposure to glyphosate residues leads to the dominance of resistant strains in the bacterial community.”

The concerns about glyphosate’s impact on the human gut microbiome stem from the fact that glyphosate works by targeting an enzyme known as 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS.) This enzyme is critical to the synthesizing of essential amino acids.

“To determine the actual impact of glyphosate on the human gut microbiota and other organisms, further empirical studies are needed to reveal glyphosate residues in food, to determine the effects of pure glyphosate and commercial formulations on microbiomes and to assess the extent to which our EPSPS amino acid markers predict bacterial susceptibility to glyphosate in in vitro and real-world scenarios,” the authors of the new paper concluded.

In addition to the six researchers from Finland, one of the authors of the paper is affiliated with the department of biochemistry and biotechnology at Rovira i Virgili University, Tarragona, Catalonia, in Spain.

“The consequences for human health are not determined in our study. However, based on previous studies… we know that alterations in the human gut microbiome may be connected to several diseases,” University of Turku researcher Pere Puigbo said in an interview.

“I hope that our research study opens the door to further experiments, in-vitro and in the field, as well as population-based studies to quantify the effect the use of glyphosate has on human populations and other organisms,” Puigbo said.

Introduced in 1974

Glyphosate is the active ingredient in Roundup herbicides and hundreds of other weed killing products sold around the world. It was introduced as a weed killer by Monsanto in 1974 and grew to become the most widely used herbicide after Monsanto’s introduction in the 1990s of crops genetically engineered to tolerate the chemical. Residues of glyphosate are commonly found on food and in water. Consequently, residues are also often detected in the urine of people exposed to glyphosate through either diet and/or application.

U.S. regulators and Monsanto owner Bayer AG maintain there are no human health concerns with glyphosate exposure when the products are used as intended, including from residues in the diet.

The body of research contradicting those claims is growing, however. The research on the potential impacts of glyphosate on the gut microbiome is not nearly as robust as the literature associating glyphosate to cancer, but is an area many scientists are probing.

In a somewhat related paper published this month, a team of researchers from Washington State University and Duke University said that they had found a correlation between the levels of bacteria and fungi in the gastrointestinal tracts of children and the chemicals found in their homes. The researchers did not look at glyphosate specifically, but were alarmed to find that children with higher levels of common household chemicals in their bloodstream showed a reduction in the amount and diversity of important bacteria in their gut.

Glyphosate in urine

An additional scientific paper published this month underscored a need for better and more data when it comes to glyphosate exposure and children.

The paper, published in the journal Environmental Health by researchers from the Institute for Translational Epidemiology at the Icahn School of Medicine at Mount Sinai in New York, is the outcome of a literature review of multiple studies reporting actual values of glyphosate in people.

The authors said they analyzed five studies published in the last two years reporting glyphosate levels measured in people, including one study in which urinary glyphosate levels were measured in children living in rural Mexico. Of 192 children living in the Agua Caliente area, 72.91 percent had detectable levels of glyphosate in their urine, and all of the 89 children living in Ahuacapán, Mexico, had detectable levels of the pesticide in their urine.

Even when including additional studies, overall, there is sparse data regarding glyphosate levels in people. Studies globally total only 4,299 people, including 520 children, the researchers said.

The authors concluded that it is not currently possible to understand the “potential relationship” between glyphosate exposure and disease, especially in children, because data collection on exposure levels in people is limited and not standardized.

They noted that despite the lack of solid data about the impacts of glyphosate on children, the amount of glyphosate residues legally allowed by U.S. regulators on food has increased dramatically over the years.

“There are gaps in the literature on glyphosate, and these gaps should be filled with some urgency, given the large use of this product and its ubiquitous presence,” said author Emanuela Taioli.

Children are especially vulnerable to environmental carcinogens and tracking exposure to products such as glyphosate in children is “a pressing public health priority,” according to the authors of the paper.

“As with any chemical, there are multiple steps involved in evaluating risk, which include gathering information about human exposures, so that the levels that produce harm in one population or animal species can be compared to typical exposure levels,” the authors wrote.

“However, we have previously shown that data on human exposure in workers and the general population are very limited. Several other gaps in knowledge exist around this product, for example results on its genotoxicity in humans are limited. The continued debate regarding the effects of glyphosate exposure makes establishing exposure levels in the general public a pressing public health issue, especially for the most vulnerable.”

The authors said monitoring of urinary glyphosate levels should be conducted in the general population.

“We continue to suggest that inclusion of glyphosate as a measured exposure in nationally representative studies like the National Health and Nutrition Examination Survey will allow for a better understanding of the risks that glyphosate may pose and allow for better monitoring of those who are most likely to be exposed and those who are more susceptible to the exposure,” they wrote.

New research adds evidence that weed killer glyphosate disrupts hormones

Print Email Share Tweet

New research is adding worrisome evidence to concerns that the widely used weedkilling chemical glyphosate may have the potential to interfere with human hormones.

In a paper published in the journal Chemosphere titled Glyphosate and the key characteristics of an endocrine disruptor: A review, a trio of scientists concluded that glyphosate appears to have eight out of ten key characteristics associated with endocrine disrupting chemicals . The authors cautioned, however, that prospective cohort studies are still needed to more clearly understand the impacts of glyphosate on the human endocrine system.

The authors, Juan Munoz, Tammy Bleak and Gloria Calaf, each affiliated with the University of Tarapacá in Chile, said their paper is the first review to consolidate the mechanistic evidence on glyphosate as an endocrine-disrupting chemical (EDC).

Some of the evidence suggests that Roundup, Monsanto’s well-known glyphosate-based herbicide, can alter the biosynthesis of the sexual hormones, according to the researchers.

EDCs may mimic or interfere with the body’s hormones and are linked with developmental and reproductive problems as well as brain and immune system dysfunction.

The new paper follows publication earlier this year of an assortment of animal studies that indicated glyphosate exposures impact reproductive organs and threaten fertility.

Glyphosate is the world’s most widely used herbicide, sold in 140 countries. Introduced commercially in 1974 by Monsanto Co, the chemical is the active ingredient in popular products such as Roundup and hundreds of other weed killers used by consumers, municipalities, utilities, farmers, golf course operators, and others around the world.

Dana Barr, a professor at Emory University’s Rollins School of Public Health, said the evidence “tends to overwhelmingly indicate that glyphosate has endocrine disrupting properties.”

“It’s not necessarily unexpected since glyphosate has some structural similarities with many other endocrine disrupting pesticides; however, it is more concerning because glyphosate use far surpasses other pesticides,” said Barr, who directs a program within a National Institutes of Health-funded human exposure research center housed at Emory. “Glyphosate is used on so many crops and in so many residential applications such that aggregate and cumulative exposures can be considerable.”

Phil Landrigan, director of the Global Observatory on Pollution and Health, and a professor of biology
at Boston College, said the review pulled together “strong evidence” that glyphosate is an endocrine disruptor.

“The report is consistent with a larger body of literature indicating that glyphosate has a wide range of adverse health effects – findings that overturn Monsanto’s long-standing portrayal of glyphosate as a benign chemical with no negative impacts on human health,” said Landrigan.

EDCs have been a subject of concern since the 1990s after a series of publications suggested that some chemicals commonly used in pesticides, industrial solvents, plastics, detergents, and other substances could have the capacity to disrupt connections between hormones and their receptors.

Scientists generally recognized ten functional properties of agents that alter hormone action, referring to these as ten “key characteristics” of endocrine-disruptors. The ten characteristics are as follows:

EDC’s can:

  • Alter hormone distribution of circulating levels of hormones
  • Induce alterations in hormone metabolism or clearance
  • Alter the fate of hormone-producing or hormone-responsive cells
  • Alter hormone receptor expression
  • Antagonize hormone receptors
  • Interact with or activate hormone receptors
  • Alter signal transduction in hormone-responsive cells
  • Induce epigenetic modifications in hormone-producing or hormone-responsive cells
  • Alter hormone synthesis
  • Alter hormone transport across cell membranes

The authors of the new paper said a review of the mechanistic data showed that glyphosate met all of the key characteristics with the exception of two:  “Regarding glyphosate, there is no evidence associated with the antagonistic capacity of hormonal receptors,” they said. As well, “there is no evidence of its impact on hormonal metabolism or clearance,” according to the authors.

Research over the last few decades has largely focused on links found between glyphosate and cancer, particularly non-Hodgkin lymphoma (NHL.) In 2015, the World Health Organization’s International Agency for Research on Cancer classified glyphosate as a probable human carcinogen.

More than 100,000 people have sued Monsanto in the United States alleging exposure to the company’s glyphosate-based herbicides caused them or their loved ones to develop NHL.

The plaintiffs in the nationwide litigation also claim Monsanto has long sought to hide the risks of its herbicides. Monsanto lost three out of three trials and its German owner Bayer AG has spent the last year and a half trying to settle the litigation out of court.

The authors of the new paper took note of the ubiquitous nature of glyphosate, saying “massive use” of the chemical has “led to a wide environmental diffusion,” including rising exposures tied to human consumption of the weed killer through food.

The researchers said that though regulators say the levels of glyphosate residue commonly found in foods are low enough to be safe, they “cannot rule out” a “potential risk” to people consuming foods containing contaminated with the chemical,  particularly grains and other plant-based foods, which often have higher levels than milk, meat or fish products.

U.S. government documents show glyphosate residues have been detected in a range of foods, including organic honey, and granola and crackers.

Canadian government researchers have also reported glyphosate residues in foods. One report issued in 2019 by scientists from Canada’s Agri-Food Laboratories at the Alberta Ministry of Agriculture and Forestry found glyphosate in 197 of 200 samples of honey they examined.

Despite the concerns about glyphosate impacts on human health, including through dietary exposure, U.S. regulators have steadfastly defended the safety of the chemical. The Environmental Protection Agency maintains that it has not found any human health risks from exposure to glyphosate.”