New weed killer studies raise concern for reproductive health

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As Bayer AG seeks to discount concerns that Monsanto’s glyphosate-based herbicides cause cancer, several new studies are raising questions about the chemical’s potential impact on reproductive health.

An assortment of animal studies released this summer indicate that glyphosate exposures impact reproductive organs and could threaten fertility, adding fresh evidence that the weed killing agent might be an endocrine disruptor. Endocrine disrupting chemicals 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.

In a paper published last month in Molecular and Cellular Endocrinology, four researchers from Argentina said that studies contradict assurances by the U.S. Environmental Protection Agency (EPA) that glyphosate is safe.

The new research comes as Bayer is attempting to settle more than 100,000 claims brought in the United States by people who allege exposure to Monsanto’s Roundup and other glyphosate-based herbicide products caused them to develop non-Hodgkin lymphoma. The plaintiffs in the nationwide litigation also claim Monsanto has long sought to hide the risks of its herbicides.

Bayer inherited the Roundup litigation when it bought Monsanto in 2018, shortly before the first of three trial victories for plaintiffs.

The studies also come as consumer groups work to better understand how to reduce their exposure to glyphosate through diet. A study published Aug. 11 found that after switching to an organic diet for just a few days, people could cut the levels of glyphosate found in their urine by more than 70 percent. Notably, the researchers found that the children in the study had much higher levels of glyphosate in their urine than did the adults. Both adults and children saw large drops in the presence of the pesticide following the diet change.

Glyphosate, the active ingredient in Roundup, is the most widely used weed killer in the world. Monsanto introduced glyphosate-tolerant crops in the 1990s to encourage farmers to spray glyphosate directly over whole fields of crops, killing weeds but not the genetically altered crops. The widespread use of glyphosate, by farmers as well as homeowners, utilities and public entities, has drawn growing concern over the years because of its pervasiveness and fears about what it could be doing to human and environmental health. The chemical is now found commonly in food and water and in human urine.

According to the Argentinian scientists, some of the reported effects of glyphosate seen in the new animal studies are due to exposure to high doses; but there is new evidence showing that even low dose exposure could also alter the development of the female reproductive tract, with consequences on fertility. When animals are exposed to glyphosate before puberty, alterations are seen in the development and differentiation of ovarian follicles and the uterus, the scientists said. Additionally, exposure to herbicides made with glyphosate during gestation could alter the development of the offspring. It all adds up to show that glyphosate and glyphosate-based herbicides are endocrine disruptors, the researchers concluded.

Agricultural scientist Don Huber, professor emeritus from Purdue University, said the new research expands on knowledge about the potential scope of damage associated with glyphosate and glyphosate-based herbicides and provides a “better grasp of understanding the seriousness of the exposure that is ubiquitous in our culture now.”

Huber has warned for years that Monsanto’s Roundup might be contributing to fertility problems in livestock.

One noteworthy study published online in July in the journal Food and Chemical Toxicology,  determined that glyphosate or glyphosate-based herbicides disrupted “critical hormonal and uterine molecular targets” in exposed pregnant rats.

A different study recently published in the journal Toxicology and Applied Pharmacology by researchers from Iowa State University looked at glyphosate exposure in mice. The researchers concluded that chronic low-level exposure to glyphosate “alters the ovarian proteome” (a set of expressed proteins in a given type of cell or organism) and “may ultimately impact ovarian function. In a related paper from the same two Iowa State researchers and one additional author, published in Reproductive Toxicology, the researchers said they did not find endocrine disrupting effects in the mice exposed to glyphosate, however.  

Researchers from the University of Georgia reported in the journal Veterinary and Animal Science that consumption by livestock of grain laced with glyphosate residues appeared to carry potential harm for the animals, according to a review of studies on the topic. Based on the literature review, glyphosate-based herbicides appear to act as “reproductive toxicants, having a wide range of effects on both the male and female reproductive systems,” the researchers said.

Alarming results were also seen in sheep. A study published in the journal Environmental Pollution looked at the impacts of glyphosate exposure on the development of the uterus in female lambs. They found changes that they said might affect the female reproductive health of sheep and show glyphosate-based herbicides acting as an endocrine disruptor.

Also published in Environmental Pollution, scientists from Finland and Spain said in a new paper that they had performed the first long-term experiment of the effects of “sub-toxic” glyphosate exposure on poultry. They experimentally exposed female and male quails to glyphosate-based herbicides from the ages of 10 days to 52 weeks.

The researchers concluded that the glyphosate herbicides could “modulate key physiological pathways, antioxidant status, testosterone, and the microbiome” but they did not detect effects on reproduction. They said the effects of glyphosate may not always be visible with “traditional, especially short-term, toxicology testing, and such testing may not fully capture the risks…”

Glyphosate and Neonicotinoids

One of the newest studies looking at glyphosate impacts on health was published this month in the International Journal of Environmental Research and Public Health.  Researchers concluded that glyphosate as well as the insecticides thiacloprid and imidacloprid, were potential endocrine disruptors.

The insecticides are part of the neonicotinoid class of chemicals and are among the most heavily used insecticides in the world.

The researchers said that they monitored the effect of glyphosate and the two neonicotinoids on two critical targets of the endocrine system: Aromatase, the enzyme responsible for estrogen biosynthesis, and estrogen receptor alpha, the main protein promoting estrogen signaling.

Their results were mixed. The researchers said with respect to glyphosate, the weed killer inhibited aromatase activity but the inhibition was “partial and weak.” Importantly the researchers said glyphosate did not induce estrogenic activity. The results were “consistent” with the screening program conducted by U.S. Environmental Protection Agency, which concluded that “there is no convincing evidence of a potential interaction with the estrogen pathway for glyphosate,” they said.

The researchers did see estrogenic activity with imidacloprid and thiacloprid, but at concentrations higher than the pesticide levels measured in human biological samples. The researchers concluded that “low doses of these pesticides should not be considered harmless,” however, because these pesticides, together with other endocrine disrupting chemicals, “might cause an overall estrogenic effect.”

The varying findings come as many countries and localities around the world evaluate whether or not to limit or ban continued use of glyphosate herbicides.

A California appeals court ruled last month that there was “abundant” evidence that glyphosate, together with the other ingredients in Roundup products, caused cancer.

Bayer asks appeals court to again cut Roundup damage award owed to California groundskeeper with cancer

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Bayer is asking a California appeals court to trim $4 million from the amount of money it owes a California groundskeeper struggling to survive cancer that a trial court found was caused by the man’s exposure to Monsanto’s Roundup herbicides.

In a “petition for rehearing” filed Monday with the Court of Appeal for the First Appellate District of California, lawyers for Monsanto and its German owner Bayer AG asked the court to cut from $20.5 million to $16.5 million the damages awarded to Dewayne “Lee” Johnson.

The appeals court “reached an erroneous decision based on a mistake of law,” according to the filing by Monsanto. The issue turns on how long Johnson is expected to live. Because evidence at trial found Johnson was expected to live “no more than two years,” he should not receive money for future pain and suffering allocated for any longer than two years – despite the fact that he continues to outlive predictions, the company argues.

Under the calculations requested by Monsanto, the court should cut from $4 million to $2 million the amount ordered for future non-economic damages, (pain and suffering.) That would reduce the overall compensatory damages (past and future) to $8,253,209. While still insisting it should not owe any punitive damages, if punitive damages are awarded they should be tallied at no more than a 1-to-1 ratio against the compensatory, bringing the total to $16,506,418, Monsanto argues in its filing.

Johnson was initially awarded $289 million by a jury in August 2018, making him the first plaintiff to win at the trial level over claims that exposure to Monsanto’s glyphosate-based herbicides causes non-Hodgkin lymphoma and that Monsanto hid the risks. The trial judge lowered the award to $78 million. Monsanto appealed seeking either a new trial or a reduced award. Johnson cross-appealed seeking reinstatement of his full damage award.

The appeals court ruled last month that there was “abundant” evidence that glyphosate, together with the other ingredients in Roundup products, caused Johnson’s cancer. And the court found that “there was overwhelming evidence that Johnson has suffered, and will continue to suffer for the rest of his life, significant pain and suffering.”

But the court said damages should be reduced to a total of $20.5 million because of the issue of Johnson’s short life expectancy.

Along with its demand for a further reduction in damages, Monsanto is asking the appeals court to grant a rehearing to “correct its analysis” and “either reverse the judgment with directions to enter judgment
for Monsanto or, at the very least, vacate the award of punitive damages.”

The Johnson trial was covered by media outlets around the world and put a spotlight on Monsanto’s efforts to manipulate the scientific record on glyphosate and Roundup and its efforts to quiet critics and influence regulators.  Lawyers for Johnson presented jurors with internal company emails and other records showing Monsanto scientists discussing ghostwriting scientific papers to try to shore up support for the safety of the company’s products, along with communications detailing plans to discredit critics, and to quash a government evaluation of the toxicity of glyphosate, the key chemical in Monsanto’s products.

Tens of thousands of plaintiffs have filed lawsuits against Monsanto making claims similar to Johnson’s, and two additional trials have taken place since the Johnson trial. Both those trials also resulted in large verdicts against Monsanto. Both are also under appeal.

Bayer’s actions to trim damage awards for Monsanto’s trial losses comes as the company seeks to settle close to 100,000 Roundup cancer claims pending around the United States in various courts. Some plaintiffs are unhappy with the settlement terms, and are threatening not to agree to the deal.

Action in Pilliod Appeal 

In separate appellate action related to the Roundup litigation, last week lawyers for Alva and Alberta Pilliod filed a brief asking the California appeals court to order damages awards for the married couple totaling $575 million. The elderly couple – both stricken with debilitating cancer they blame on exposure to Roundup – won more than $2 billion at trial, but the trial judge then lowered the jury award to $87 million.

The slashing of the damage award was excessive, according to lawyers representing the couple, and does not sufficiently punish Monsanto for its wrongdoing.

“The three California juries, four trial judges, and three appellate justices who have reviewed Monsanto’s misconduct have unanimously agreed there is “substantial evidence that Monsanto acted with a willful and conscious disregard of others’ safety,” the Pilliod brief states.  “Monsanto’s claim that it is the victim of “injustice” in this case rings increasingly hollow in light of these unanimous and repeated findings.”

The lawyers are asking the court to award a 10-to-1 ratio of punitive damages to compensatory damages.

“The true victims of injustice in this case are the Pilliods, who have both suffered from a devastating and debilitating disease because of Monsanto’s malfeasance,” the brief states. “The jury, in determining that decent citizens need not tolerate Monsanto’s reprehensible behavior, rightly concluded that only a substantial punitive damage could punish and deter Monsanto.”

Some U.S. Roundup plaintiffs balk at signing Bayer settlement deals; $160,000 average payout eyed

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Plaintiffs in the U.S. Roundup litigation are starting to learn the details of what Bayer AG’s $10 billion settlement of cancer claims actually means for them individually, and some are not liking what they see.

Bayer said in late June it had negotiated settlements with several major plaintiffs’ law firms in a deal that would effectively close out the bulk of more than 100,000 pending claims against Monsanto, which was purchased by Bayer in 2018. Plaintiffs in the litigation allege they developed non-Hodgkin lymphoma from exposure to Monsanto’s Roundup and other herbicides made with a chemical called glyphosate, and that Monsanto covered up the risks.

While the deal initially seemed like good news for the plaintiffs – some who’ve struggled for years with cancer treatments and others who sued on behalf of deceased spouses – many are finding they could end up with little to no money, depending upon a range of factors. The law firms, however, could pocket hundreds of millions of dollars.

“It’s a win for the law firms and a slap in the face of the harmed” said one plaintiff, who did not want to be named.

Plaintiffs are being told they must decide in the next few weeks if they’re going to accept the settlements, even though they won’t know how much they will personally be paid until much later. All the settlement deals order the plaintiffs not to talk publicly about the details, threatening them with sanctions if they discuss the settlements with anyone other than “immediate family members” or a financial advisor.

This has angered some who say they are considering rejecting the settlements in favor of seeking out other law firms to handle their claims. This reporter has reviewed documents sent to multiple plaintiffs.

For those who do agree, payments could be made as early as February, though the process of paying all the plaintiffs is expected to stretch out a year or more. Communications sent out from law firms to their Roundup clients sketch out both the process each cancer-stricken individual will need to go through to obtain a financial payout and what those payouts might amount to. The terms of the deals vary from law firm to law firm, meaning similarly situated plaintiffs may end up with vastly different individual settlements.

One of the stronger deals appears to be one negotiated by The Miller Firm, and even that is disappointing to some of the firm’s clients. In communications to clients, the firm said it was able to negotiate roughly $849 million from Bayer to cover the claims of more than 5,000 Roundup clients. The firm estimates the average gross settlement value for each plaintiff at roughly $160,000. That gross amount will further be reduced by the deduction of attorneys’ fees and costs.

Though attorneys’ fees can vary by firm and plaintiff, many in the Roundup litigation are charging 30-40 percent in contingency fees.

To be eligible for the settlement, plaintiffs must have medical records supporting diagnosis of certain types of non-Hodgkin lymphoma and be able to show they were exposed at least a year before their diagnosis.

The Miller Firm has been at the forefront of the Roundup litigation since the outset, unearthing many of the damning internal Monsanto documents that helped win all three Roundup trials held to date. The Miller Firm handled two of those trials, bringing in lawyers from the Los Angeles firm of Baum Hedlund Aristei & Goldman to help with the case of  Dewayne “Lee” Johnson after Miller Firm founder Mike Miller was severely injured in an accident just prior to trial. The two firms additionally worked together in winning the case of husband-and-wife plaintiffs, Alva and Alberta Pilliod.  Johnson was awarded $289 million and the Pilliods were awarded more than $2 billion though the trial judges in each case lowered the awards.

Earlier this month, a California appeals court rejected Monsanto’s effort to overturn the Johnson verdict, ruling that there was “abundant” evidence that Roundup products caused Johnson’s cancer but reducing Johnson’s award to $20.5 million. Appeals are still pending in the other two verdicts against Monsanto.

Scoring Plaintiffs

To determine how much each plaintiff receives from the settlement with Bayer, a third-party administrator will score each individual using factors that include the type of non-Hodgkin lymphoma each plaintiff  developed; the plaintiff’s age at diagnosis; the severity of the person’s cancer and the extent of treatment they endured; other risk factors; and the amount of exposure they had to Monsanto herbicides.

One element of the settlement that caught many plaintiffs off guard was learning that those who ultimately receive money from Bayer will have to use their funds to pay back part of the costs of their cancer treatments that were covered by Medicare or private insurance. With some cancer treatments running into the hundreds of thousands and even millions of dollars, that could quickly erase a plaintiff’s payout. The law firms are lining up third-party contractors who will negotiate with the insurance providers to seek discounted reimbursements, the plaintiffs have been told. Typically in this sort of mass tort litigation, those medical liens can be substantially reduced, the law firms said.

In one aspect of the deal welcomed by plaintiffs, the settlements will be structured to avoid tax liability, according to the information provided to plaintiffs.

Risks in Not Settling  

The law firms must get a majority of their plaintiffs to agree to the terms of the settlements in order for them to proceed. According to the information provided to plaintiffs, settlements are desired now because of a number of risks associated with continuing to pursue additional trials. Among the risks identified:

  • Bayer has threatened to file for bankruptcy, and if the company did take that route, settling Roundup claims would take far longer and likely ultimately result in far less money for plaintiffs.
  • The Environmental Protection Agency (EPA) issued a letter last August telling Monsanto that the agency won’t allow for a cancer warning on Roundup. That helps Monsanto’s future chances of prevailing in court.
  • Covid-related court delays mean additional Roundup trials are unlikely for a year or more.

It is not unusual for plaintiffs in mass tort litigation to walk away disappointed even with seemingly large settlements negotiated for their cases.  The 2019 book “Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation” by Elizabeth Chamblee Burch, the Fuller E. Callaway Chair of Law at the University of Georgia,  makes the case that a lack of checks and balances in mass tort litigation benefits nearly everyone involved except the plaintiffs.

Burch cites as an example litigation over the acid-reflux medicine Propulsid, and said she found that of the 6,012 plaintiffs who entered into the settlement program, only 37 ultimately received any money. The rest received no payouts but had already agreed to dismiss their lawsuits as a condition of entering into the settlement program. Those 37 plaintiffs collectively received little more than $6.5 million (roughly $175,000 each on average), while the lead law firms for the plaintiffs received $27 million, according to Burch,

Setting aside what individual plaintiffs may or may not walk away with,  some legal observers close to the Roundup litigation said a greater good has been achieved with the exposure of corporate wrongdoing by Monsanto.

Among the evidence that has emerged through the litigation are internal Monsanto documents showing the company engineered the publishing of scientific papers that falsely appeared to be created solely by independent scientists; the funding of, and collaborating with, front groups that were used to try to discredit scientists reporting harm with Monsanto’s herbicides; and collaborations with certain officials inside the Environmental Protection Agency (EPA) to protect and promote Monsanto’s position that its products were not cancer-causing.

Several countries around the world, as well as local governments and school districts, have moved to ban glyphosate herbicides, and/or other pesticides because of the revelations of the Roundup litigation.

(Story first appeared in Environmental Health News.)

Appeals court upholds groundskeeper’s Roundup cancer trial win over Monsanto

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In yet another court loss for Monsanto owner Bayer AG, an appeals court rejected the company’s effort to overturn the trial victory notched by a California school groundskeeper who alleged exposure to Monsanto’s glyphosate herbicides caused him to develop cancer, though the court did say damages should be cut to $20.5 million.

The Court of Appeal for the First Appellate District of California said Monday that Monsanto’s arguments were unpersuasive and Dewayne “Lee” Johnson was entitled to collect $10.25 million in  compensatory damages and another $10.25 million in punitive damages. That is down from a total of $78 million the trial judge allowed.

“In our view, Johnson presented abundant—and certainly substantial— evidence that glyphosate, together with the other ingredients in Roundup products, caused his cancer,” the court stated. “Expert after expert provided evidence both that Roundup products are capable of causing non-Hodgkin’s lymphoma…  and caused Johnson’s cancer in particular.”

The court further noted that “there was overwhelming evidence that Johnson has suffered, and will continue to suffer for the rest of his life, significant pain and suffering.”

The court said that Monsanto’s argument that scientific findings about glyphosate’s links to cancer constituted a “minority view” was not supported.

Notably, the appeals court added that punitive damages were in order because there was sufficient evidence that Monsanto acted with “willful and conscious disregard of others’ safety.”

Mike Miller, whose Virginia law firm represented Johnson at trial along with the Baum Hedlund Aristei & Goldman firm of Los Angeles, said he was cheered at the court’s confirmation that Johnson developed cancer from his use of Roundup and that the court affirmed the award of punitive damages for “Monsanto’s willful misconduct.”

“Mr Johnson continues to suffer from his injuries. We are proud to fight for Mr Johnson and his pursuit of justice,” Miller said.

Monsanto owes annual interest at the rate of 10 percent from April of 2018 until it pays the final judgment.

The reduction in damages is tied in part to the fact that doctors have told Johnson his cancer is terminal and he is not expected to live very much longer. The court agreed with Monsanto that because compensatory damages are designed to compensate for future pain, mental suffering, loss of enjoyment of life, physical impairment, etc…  Johnson’s short life expectancy legally means the future “non-economic” damages awarded by the trial court must be reduced.

Brent Wisner, one of Johnson’s trial attorneys, said the reduction in damages was the result of a “deep flaw in California tort law.”

“Basically, California law does not allow a plaintiff to recover for a shortened life expectancy,” Wisner said. “This effectively rewards a defendant for killing a plaintiff, as opposed to just injuring him. It is madness.”

A spotlight on Monsanto’s conduct

It was just two months after Bayer bought Monsanto, in August 2018, that a unanimous jury awarded Johnson $289 million, including $250 million in punitive damages, finding that not only did Monsanto’s herbicides cause Johnson to develop non-Hodgkin lymphoma, but that the company knew of the cancer risks and failed to warn Johnson. The lawsuit involved two Monsanto glyphosate herbicide products – Roundup and Ranger Pro.

The trial judge lowered the total verdict to $78 million but Monsanto appealed the reduced amount. Johnson cross appealed to reinstate the $289 million verdict.

The Johnson trial was covered by media outlets around the world and put a spotlight on questionable Monsanto conduct. Lawyers for Johnson presented jurors with internal company emails and other records showing Monsanto scientists discussing ghostwriting scientific papers to try to shore up support for the safety of the company’s products, along with communications detailing plans to discredit critics, and to quash a government evaluation of the toxicity of glyphosate, the key chemical in Monsanto’s products.

Internal documents also showed that Monsanto expected the International Agency for Research on Cancer would classify glyphosate as a probable or possible human carcinogen in March of 2015 (the classification was as a probable carcinogen) and worked out a plan in advance to discredit the cancer scientists after they issued their classification.

Tens of thousands of plaintiffs have filed lawsuits against Monsanto making claims similar to Johnson’s, and two additional trials have taken place since the Johnson trial. Both those trials also resulted in large verdicts against Monsanto. Both are also under appeal.

In June, Bayer said it had reached a  settlement agreement with attorneys representing 75 percent of the roughly 125,000 filed and yet-to-be filed claims initiated by U.S. plaintiffs who blame exposure to Monsanto’s Roundup for their development of non-Hodgkin lymphoma. Bayer said it will provide $8.8 billion to $9.6 billion to resolve the litigation. But lawyers representing more than 20,000 additional plaintiffs say they have not agreed to settle with Bayer and those lawsuits are expected to continue to work their way through the court system.

In a statement issued after the court ruling, Bayer said it stands behind the safety of Roundup: “The appeal court’s decision to reduce the compensatory and punitive damages is a step in the right direction, but we continue to believe that the jury’s verdict and damage awards are inconsistent with the evidence at trial and the law. Monsanto will consider its legal options, including filing an appeal with the Supreme Court of California.”

EPA removes name of U.S. official from warning of glyphosate cancer links

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(Update with EPA explanation)

In an unusual move, the Environmental Protection Agency (EPA) has deleted the name of a high-ranking U.S.  health official from a public comment that warned of cancer links to the weed killing chemical glyphosate and called for a halt to industry manipulation of research.

The public comment in question was submitted to the EPA and posted on the agency’s website under the name of Patrick Breysse, the director of the National Center for Environmental Health and the Agency for Toxic Substances and Disease Registry (ATSDR). The ATSDR is part of the U.S. Department of Health and Human Services.

The comment under Breysse’s name was filed last year with the EPA in response to an updated agency review of glyphosate and urged the agency to review “documented evidence” that glyphosate was harmful and should be banned.

For months the comment sat on the EPA website under Breysse’s name. It was only after U.S. Right to Know sought commentary last week from Breysse about his statement that the EPA removed his name. The comment now is attributed to “Anonymous,” after Breysse’s employer determined it was not actually submitted by him, according to the EPA.

Glyphosate is the active ingredient in Roundup and other herbicides and was popularized by Monsanto, a unit of Bayer AG. It is considered the most widely used herbicide in the world. It is also one of the most controversial and is the subject of lawsuits brought by tens of thousands of people who claim they developed cancer because of exposure to Roundup and other glyphosate herbicides made by Monsanto.

The EPA has steadfastly defended the safety of glyphosate despite findings by many independent scientists that glyphosate herbicides can cause a range of illness and disease, including non-Hodgkin lymphoma.

The comment under Breysse’s name contradicted the EPA’s position:

“Numerous studies have linked its use to an increase in lymphomas, and it’s time we stopped letting the chemical industry manipulate research to serve its own interest. U.S. citizens need to trust the Environmental Protection Agency to operate in our best interest, which means weighing evidence from neutral scientific sources not vested in the outcome.”

Notably, Breysse is also the ATSDR official who was pressured by EPA officials in 2015 at the behest of Monsanto to put a halt to a review of glyphosate toxicity then just getting underway at the ATSDR. The push to delay the ATSDR review of glyphosate came because Monsanto feared the ATSDR would agree with the International Agency for Research on Cancer (IARC) in finding cancer links to glyphosate, internal Monsanto correspondence shows.

One internal Monsanto email said EPA official Jess Rowland told Monsanto he should “get a medal” if he was successful in killing the ATSDR glyphosate review.

The ATSDR review was in fact delayed until 2019 after the pressure from Monsanto and EPA officials. When the report was finally released, it did confirm Monsanto’s fears, lending support to the 2015 IARC concerns about links between cancer and glyphosate. The ATSDR report was signed by Breysse.

When asked about the change in attribution to the public comment, the EPA said it removed Breysse’s name after the Centers for Disease Control and Prevention, which oversees ATSDR, told EPA the comment was not submitted by Breysse and asked that it be deleted or edited. Rather than delete the comment, EPA elected to keep the comment in the docket but changed the submitter’s name to “anonymous.”

The EPA said it does not screen or authenticate comments submitted.

The press office for the National Center for Environmental Health also said Breysse did not submit the comment in question. Breysse did not respond to a request to confirm or deny his authorship of the comment on the EPA website.

The original comment and the changed one are shown below:

Bayer backs away from plan to contain future Roundup cancer claims

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Monsanto owner Bayer AG is backing away from a plan to contain future Roundup cancer claims after a federal judge made it clear he would not approve the scheme, which would delay new trials and limit jury decision-making.

The plan concocted by Bayer and a small group of lawyers was filed last month in U.S. District Court for the Northern District of California as part of a effort by Bayer to put an end to sweeping litigation that has so far led to three losses in three jury trials, staggering punitive damage awards and shareholder discontent. More than 100,000 people in the United States claim exposure to Monsanto’s glyphosate-based Roundup herbicides caused them to develop non-Hodgkin lymphoma (NHL) and that Monsanto long knew about and covered up the cancer risks.

On Monday Judge Vince Chhabria issued an order setting a hearing on the matter for July 24 and making it clear he would not approve the settlement plan. He was “skeptical of the propriety and fairness of the proposed settlement,” Chhabria wrote in the order.

Prior to the judge’s order, multiple parties filed notices of their own opposition to the Bayer plan; citing “major deviations from ordinary practices” called for in the proposed settlement.

In response, on Wednesday the group of lawyers who had structured the deal with Bayer filed a notice of withdrawal of their plan.

The proposed settlement plan for future class action litigation was separate from the settlement agreement Bayer made with lawyers for plaintiffs who have already filed cases and is designed to help Bayer contain and manage future liability.  Under the structure put together by Bayer and a small group of plaintiffs’ lawyers the class action settlement would have applied to anyone exposed to Roundup who had not filed a lawsuit or retained a lawyer as of June 24, 2020, regardless of whether or not that person already had been diagnosed with cancer they believe was due to Roundup exposure.

The plan would have delayed the filing of new cases for four years, and called for the establishment of a five-member “science panel” that would take any future findings on cancer claims out of the hands of  juries. Instead, a “Class Science Panel” would be established to determine whether Roundup can cause non-Hodgkin lymphoma, and if so, at what minimum exposure levels.  Bayer would get to appoint two of the five panel members. If the panel determined there was no causal connection between Roundup and non-Hodgkin lymphoma then the class members would be barred from future such claims.

Judge Chhabria took issue with the whole idea of a science panel. In his order, the judge wrote:

“In an area where the science may be evolving, how could it be appropriate to lock in a decision from a panel of scientists for all future cases? For examine, imagine the panel decides in 2023 that Roundup is not capable of causing cancer. Then imagine that a new, reliable study is published in 2028 which strongly undermines the panel’s conclusion. If a Roundup user is diagnosed with NHL in 2030, is it appropriate to tell them that they’re bound by the 2023 decision of the panel because they did not opt out of a settlement in 2020?”

Bayer said it would set aside $1.25 billion for the arrangement. The money would be used to compensate class members diagnosed with NHL for the “effects of the delay” in litigation, and to fund research into the diagnosis and treatment of NHL, among other things.

The plaintiffs’  attorneys who put the plan together with Bayer stood to make more than $150 million in fees payable by Bayer. They are not the same law firms that have led the litigation to date. This group of law firms include Lieff Cabraser Heimann & Bernstein; Audet & Partners; The Dugan Law Firm; and lawyer Samuel Issacharoff, Reiss Professor of Constitutional Law at New York University School of Law.

Several members of the lead law firms who won the three Roundup cancer trials oppose the proposed class action settlement plan, saying it would deprive future plaintiffs of their rights while enriching those other lawyers who have not previously been at the forefront of the Roundup litigation.

It is not clear how the withdrawal of this proposed class action settlement plan might impact the larger settlement of existing claims. Bayer said last month it will pay up to $9.6 billion to resolve roughly 75 percent of the current claims and will continue working to settle the rest. That settlement does not require court approval.

Bayer issued a statement Wednesday saying it remains “strongly committed to a resolution that simultaneously addresses both the current litigation on reasonable terms and a viable solution to manage and resolve potential future litigation.”

Challenge eyed to class action plan for Bayer Roundup settlement

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A plan to delay any new Roundup cancer claims for years and shift the key question of whether or not the weed killer causes cancer from a jury to a hand-picked panel of scientists faces potential opposition from some of the plaintiffs’ attorneys who initiated and led the mass tort claims against Roundup maker Monsanto, sources close to the litigation said.

Several members of the lead law firms who won three out of three trials pitting cancer patients against Monsanto are considering challenging the terms of a proposed “class action” settlement negotiated between Monsanto owner Bayer AG and a small team of  lawyers who have not previously been at the forefront of the Roundup litigation, the sources said.

The class action settlement proposal is an element of the sweeping $10 billion Roundup litigation settlement Bayer announced June 24.

In each of the trials held to date, juries found that the weight of scientific evidence proved that Roundup exposure caused the plaintiffs to develop non-Hodgkin lymphoma (NHL) and that Monsanto covered up the risks. But under the proposal that question would go to a five-member “science panel,” not a jury.

“It’s basically depriving a plaintiff of their constitutional right to a jury trial,” said one source close to the litigation.

The proposed class settlement would apply to anyone exposed to Roundup who had not filed a lawsuit or retained a lawyer as of June 24, 2020, regardless of whether or not that person already had been diagnosed with cancer they believe was due to Roundup exposure.

The plan was put together by Bayer and the law firms of Lieff Cabraser Heimann & Bernstein; Audet & Partners; The Dugan Law Firm; and lawyer Samuel Issacharoff, Reiss Professor of Constitutional Law at New York University School of Law.

The agreement was reached after nearly one year of “unrelenting efforts” of negotiations, lawyer Elizabeth Cabraser said in a declaration to the court supporting the proposed class settlement.

It would set a “standstill period” in which plaintiffs in the class cannot file new litigation related to Roundup. And it calls for class members to release “any claims against Monsanto for punitive damages and for medical monitoring related to Roundup exposure and NHL.”

Notably, the plan states that rather than go forward with another jury trial, a panel of scientists will first be set up to determine the “right answer” to “the threshold question” of whether or not there is a causal link between Roundup and NHL.

The plan calls for Bayer to pay up to $150 million for the fees and costs of the attorneys’ involved and “class representative service awards” up to $25,000 to each or a total of $100,000.

Overall, Bayer said it would set aside $1.25 billion for the arrangement. The money would be used to compensate class members diagnosed with NHL for the “effects of the delay” in litigation, and to fund research into the diagnosis and treatment of NHL, among other things.

A motion seeking preliminary approval of the class settlement was filed Wednesday with the U.S. District Court for the Northern District of California to be handled by Judge Vince Chhabria. Chhabria has been overseeing numerous Roundup lawsuits that have been bundled together as multidistrict litigation. In shepherding a large number of the lawsuits already filed, Chhabria oversaw one of the Roundup trials, as well as what is known as a “Daubert” hearing, in which he heard days of scientific testimony from both sides and then decided there was sufficient scientific evidence of causation for the litigation to proceed.

The class settlement proposal was negotiated separately from the main settlement made with the lead law firms.

In the main settlement, Bayer agreed to provide $8.8 billion to $9.6 billion to resolve roughly 75 percent of the roughly 125,000 filed and unfiled claims brought by plaintiffs who blame exposure to Monsanto’s Roundup for their development of non-Hodgkin lymphoma.  Lawyers representing more than 20,000 additional plaintiffs say they have not agreed to settle with Bayer and those lawsuits are expected to continue to work their way through the court system.

Even though Monsanto lost each of the three trials held to date, Bayer maintain the jury decisions were flawed and based on emotion and not sound science.

Science Panel Selection

Bayer and the lawyers for the proposed class would work together to select the five scientists to sit on what would be a “neutral, independent” panel, according to the plan.  If they cannot agree on the make-up of the panel then each side will choose two members and those four members will choose the fifth.

No scientist who acted as an expert in the federal multidistrict Roundup litigation will be allowed to be on the panel. Notably, neither will anyone who “communicated with any expert” in the litigation about the subject matter.

The panel would have four years to review scientific evidence but can petition for an extension of time if necessary. The determination would be binding on both sides, the plan states. If the panel determines there is a causal link between Roundup and NHL, plaintiffs can go forward to seek trials of their individual claims.

“Knowledge is power and this Settlement empowers class members to hold Monsanto accountable for their injuries if and when the Science Panel determines that general causation is satisfied,” the plan states.

The filing with the federal court requests a preliminary approval hearing within 30 days.

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.

Big Ag groups argue court cannot tell EPA when to ban dicamba

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The heaviest of Big Ag’s heavy hitters told a federal court it should not try to stop GMO cotton and soybean farmers from using illegal dicamba weed killers through the end of July, despite the court’s order earlier this month for an immediate ban.

Six national trade associations, all of which have long-standing financial ties to Monsanto and the other companies selling the dicamba products in question,  filed a brief on Wednesday with the U.S. Court of Appeals for the Ninth Circuit urging the court not to try to interfere with the Environmental Protection Agency’s (EPA) announcement that farmers could continue to use the dicamba products through July 31.

They also asked the court not to hold the EPA in contempt as has been requested by the groups that won the June 3 court order issuing the ban.

“America’s soybean and cotton growers would risk severe financial harm if prevented from using Dicamba Products this growing season,” states the brief filed by the American Farm Bureau Federation, American Soybean Association, National Cotton Council of America, National Association of Wheat Growers, National Corn Growers Association, and National Sorghum Producers.

Separately, CropLife America, an influential lobbyist for the agrichemical industry, filed a brief  stating it wanted to provide “Helpful Information to the Court.” CropLife stated in the filing that the court has no authority over how the EPA proceeds to cancel the use of pesticide products such as dicamba weed killers.

The moves are but the latest in a dramatic flurry of events that followed the Ninth Circuit ruling, which found that the EPA violated the law when it approved dicamba products developed by Monsanto – owned by Bayer AG, as well as products sold by BASF, and DuPont, owned by Corteva Inc.

The court ordered an immediate ban on use of each of the companies’ products, finding that the EPA “substantially understated the risks” those products pose to farmers growing crops other than genetically engineered cotton and soy.

The EPA appeared to flout the order, however, when it told the cotton and soy farmers they could continue to spray the herbicides in question through July 31.

The Center for Food Safety (CFS) and other groups that originally took the EPA to court over the matter went back to court last week, demanding that the 9th Circuit hold the EPA in contempt. The court is now considering that motion.

“EPA and the pesticide companies have tried to confuse the issue and try to intimidate the Court,” said George Kimbrell, CFS legal director and counsel for the petitioners. “The Court held the product uses unlawful and EPA’s manipulations cannot change that.”

The order banning the company’s dicamba products has triggered an uproar in farm country because many soybean and cotton farmers planted millions of acres of genetically altered dicamba-tolerant crops developed by Monsanto with the intent of treating weeds in those fields with the dicamba herbicides made by the three companies. The crops tolerate the dicamba while the weeds die.

The farm lobby groups said in their brief that 64 million acres were planted with the dicamba-tolerant seeds this season. They said if those farmers cannot spray over their fields with the dicamba products they will be “largely defenseless against weeds resistant to other herbicides, causing
potentially significant financial consequences from yield losses.”

When Monsanto, BASF and DuPont/Corteva rolled out their dicamba herbicides a few years ago they  claimed the products would not volatize and drift into neighboring fields as older versions of dicamba weed killing products were known to do. But those assurances proved false amid widespread complaints of dicamba drift damage.

More than one million acres of crops not genetically engineered to tolerate dicamba were reported damaged last year in 18 states, the federal court noted in its ruling.

“The EPA’s mission is to protect human health and the environment…” said National Family Farm Coalition board president Jim Goodman. “Their contempt for this mission could not be more clearly expressed than their flagrant disregard of the Ninth Circuit Court of Appeals’ ruling to stop over-the-top applications of dicamba immediately to prevent millions of acres of farmers’ crops from being destroyed.”

In February, a Missouri jury ordered Bayer and BASF to pay a peach farmer $15 million in compensatory damages and $250 million in punitive damages for dicamba damage to the farmer’s orchards. The jury concluded that  Monsanto and BASF conspired in actions they knew would lead to widespread crop damage because they expected it would increase their own profits

Panicked chemical giants seek leeway in court ban on their weed killers

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Citing an “emergency,” chemical giants BASF and DuPont have asked a federal court to allow them to intervene in a case in which the court earlier this month ordered their dicamba herbicides to be immediately banned along with a dicamba product made by Monsanto owner Bayer AG.

The action by the chemical companies follows a June 3 ruling by the U.S. Court of Appeals for the Ninth Circuit that said the Environmental Protection Agency (EPA) had violated the law when it approved the dicamba products developed by Monsanto/Bayer, BASF and DuPont, owned by Corteva Inc.

The court ordered an immediate ban on use of each of the company’s dicamba products, finding that the EPA “substantially understated the risks” of the dicamba herbicides and “failed entirely to acknowledge other risks.”

The EPA flouted that order, however, telling farmers they could continue to spray the herbicides in question through the end of July.

The consortium of farm and consumer groups that originally filed the case against the EPA rushed back to court last week, asking for an emergency order holding the EPA in contempt.  The court gave the EPA until the end of the day Tuesday, June 16, to respond.

Uproar in Farm Country

The order banning the companies’ dicamba products has triggered an uproar in farm country because many soybean and cotton farmers planted millions of acres of dicamba-tolerant crops developed by Monsanto with the intent of treating weeds in those fields with the dicamba herbicides made by the three companies.

The “dicamba crop system” provides for farmers to plant their fields with dicamba-tolerant crops, which they can then spray “over-the-top” with dicamba weed killer. The system has both enriched the companies selling the seeds and chemicals and and helped farmers growing the special dicamba-tolerant cotton and soy deal with stubborn weeds that are resistant to glyphosate-based Roundup products.

But for the large number of farmers who do not plant the genetically engineered dicamba-tolerant crops, widespread use of dicamba herbicides has meant damage and crop losses because dicamba tends to volatize and drift long distances where it can kill crops, trees and shrubs that are not genetically altered to withstand the chemical.

The companies claimed their new versions of dicamba would not volatize and drift as older versions of dicamba weed killing products were known to do. But those assurances proved false amid widespread complaints of dicamba drift damage. More than one million acres of crop damage was reported last year in 18 states, the federal court noted in its ruling.

Many farmers initially celebrated the court ruling and were relieved that their farms and orchards would be spared this summer from the dicamba damage they’ve experienced in prior summers. But the relief was short-lived when the EPA said it would not immediately enforce the court-ordered ban.

In a filing made Friday, BASF pleaded with the court not to enforce an immediate ban and told the court that it will need to close a manufacturing facility in Beaumont, Texas, that currently “operates 24 hours a day nearly continuously through the year” if it is not able to produce its dicamba herbicide brand called Engenia. BASF has spent $370 million in recent years improving the plant and employs 170 people there, the company said.

Noting “significant investments” in its product, BASF also told the court that there is enough of its product currently throughout its “customer channel” to treat 26.7 million acres of soybeans and cotton.  BASF has an additional $44 million worth of the Engenia dicamba product in its possession, enough to treat 6.6 million acres of soybeans and cotton, the company said.

DuPont/Corteva made a similar argument, telling the court in its filing that the ban “directly harms” the company “as well as the many farmers across this country that are in the midst of the growing season.”  It will damage the company’s “reputation” if its herbicide is banned, the company told the court.

Moreover, DuPont/Corteva expects to generate “significant revenues” from the sales of its dicamba herbicide, called FeXapan and will lose that money if the ban is enforced, the company said.

Monsanto was active in the case supporting the EPA approvals prior to the ruling, but both BASF and DuPont asserted wrongly that the court case applied only to Monsanto’s products and not to theirs. The court made it clear, however, that the EPA illegally approved the products made by all three companies.

Led by the Center for Food Safety,  the petition against the EPA was also brought by the National Family Farm Coalition, Center for Biological Diversity, and Pesticide Action Network North America.

In asking the court to find the EPA in contempt, the consortium warned of the crop damage to come if the dicamba products are not banned immediately.

“EPA cannot get away with allowing the spraying of 16 million more pounds of dicamba and resulting damage to millions of acres, as well as significant risks to hundreds of endangered species,” the consortium said in its filing. “Something else is at stake too: the rule of law. The Court must act to prevent injustice and uphold the integrity of the judicial process. And given the blatant
disregard EPA showed for the Court’s decision, Petitioners urge the Court to hold EPA in contempt.”