Dying man asks California Supreme Court to restore jury award in Monsanto Roundup case

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The school groundskeeper who won the first-ever trial over allegations that Monsanto’s Roundup causes cancer is asking the California Supreme Court to restore $250 million in punitive damages awarded by the jury who heard his case but then slashed by an appeals court to $20.5 million.

Notably, the appeal by plaintiff Dewayne “Lee” Johnson has larger implications than his own individual case. Johnson’s lawyer are urging the court to address a legal twist that can leave people such as Johnson who are facing death in the near term with lower damage awards than others expected to live many years in suffering and pain.

“It is long past time for California courts to recognize, as other courts do, that life itself has value and that those who maliciously deprive a plaintiff of years of life should be made to fully compensate that plaintiff and be punished accordingly,” Johnson’s attorneys wrote in their request for the state supreme court review. “The jury ascribed meaningful value to Mr. Johnson’s life, and for that he is grateful. He asks this Court to respect the jury’s decision and restore that value. ”

A unanimous jury found in August 2018 that exposure to Monsanto’s glyphosate-based herbicides, known best by the brand name Roundup, caused Johnson to develop non-Hodgkin lymphoma. The jury further found that Monsanto acted to hide the risks of its products in conduct so egregious that the company should pay Johnson $250 million in punitive damages on top of $39 million in past and future compensatory damages.

Upon appeal from Monsanto, which was purchased by the German company Bayer AG in 2018, the trial judge reduced the $289 million 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 in the case then cut the award to $20.5 million, citing the fact that Johnson was expected to live only a short time.

The appeals court reduced the damages award despite finding there was “abundant” evidence that glyphosate, together with the other ingredients in Roundup products, caused Johnson’s cancer and 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 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.

Johnson’s trial victory spurred a frenzied filing of tens of thousands of additional lawsuits. Monsanto lost three out of three trials before agreeing this June to pay more than $10 billion to settle close to 100,000 such claims.

The settlement is still in flux, however, as Bayer wrestles with how to forestall future litigation.

In an interview, Johnson said he knew the legal battle with Monsanto could continue for many more years but he was committed to trying to hold the company accountable. He has managed to keep his illness in check so far with regular chemotherapy and radiation treatments, but is not certain how long that will continue.

“I don’t think any amount would be enough to punish that company,” Johnson said.

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.

U.S. study shows switch to organic diet can quickly clear pesticide from our bodies

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A new study published Tuesday found that after switching to an organic diet for just a few days, people could cut the levels of a pesticide linked to cancer found in their urine by more than 70 percent.

The researchers collected a total of 158 urine samples from four families –seven adults and nine children – and examined the samples for the presence of the weed killer glyphosate, which is the active ingredient in Roundup and other popular herbicides. The participants spent five days on a completely non-organic diet and five days on a completely organic diet.

“This study demonstrates that shifting to an organic diet is an effective way to reduce body burden of glyphosate… This research adds to a growing body of literature indicating that an organic diet may reduce exposure to a range of pesticides in children and adults,” states the study, which was published in the journal Environmental Research.

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. The mean urinary glyphosate levels for all subjects dropped 70.93 percent.

Despite its small size, the study is an important one because it shows people can markedly reduce their exposures to pesticides in food even without regulatory action, said Bruce Lanphear, Professor of Health Sciences at Simon Fraser University.

Lanphear noted that the study showed children appear to be more heavily exposed than adults, though the reason is unclear.  “If the food is contaminated with pesticides, they will have a higher body burden,” Lanphear said.

Roundup and other glyphosate herbicides are commonly sprayed directly over the top of growing fields of corn, soybeans, sugar beets, canola, wheat, oats and many other crops used to make food, leaving traces in finished food products consumed by people and animals.

The Food and Drug Administration has found glyphosate even in oatmeal  and honey, among other products. And consumer groups have documents glyphosate residues in an array of snacks and cereals.

But glyphosate and glyphosate-based herbicides such as Roundup have been linked to cancer and other illness and disease in several studies over the years and growing awareness of the research has led to growing fears about exposure to the pesticide through the diet.

Many groups have documented the presence of glyphosate in human urine in recent years. But there have been few studies comparing glyphosate levels in people eating a conventional diet versus a diet made up only of foods grown organically, without the use of pesticides such as glyphosate.

“The outcomes of this research validate the previous research in which organic diets could minimize the intakes of agrochemicals, such as glyphosate,” said Chensheng Lu, adjunct professor of the University of Washington School of Public Health and honorary professor, Southwest University, Chongqing China.

“In my opinion, the underlying message of this paper is to encourage producing more organic foods for people who want to protect themselves from the exposure of agrochemicals. This paper has proven again this absolute right pathway for prevention and protection,” Lu said.

The study was authored by John Fagan and Larry Bohlen, both of the Health Research Institute in Iowa, along with Sharyle Patton, director of the Commonweal Biomonitoring Resource Center in California and Kendra Klein, a staff scientist at Friends of the Earth, a consumer advocacy group.

The families participating in the study live in Oakland, California, Minneapolis, Minnesota, Baltimore, Maryland and Atlanta, Georgia.

The study is the second of a two-part research project. In the first, levels of 14 different pesticides were measured in the urine of participants.

Glyphosate is of particular concern because it is the most widely used herbicide in the world and is sprayed on so many food crops. The International Agency for Research on Cancer, part of the World Health Organization, said in 2015 that researched showed glyphosate to be a probable human carcinogen.

Tens of thousands of people have sued Monsanto claiming exposure to Roundup caused them to develop non-Hodgkin lymphoma, and many countries and localities around the world have recently limited or banned glyphosate herbicides or are considering doing so.

Bayer, which bought Monsanto in 2018, is attempting to settle more than 100,000 such claims brought in the United States. The plaintiffs in the nationwide litigation also claim Monsanto has long sought to hide the risks of its 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.

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.”

U.S. regulators relied for years on flawed pesticide data provided by Dow Chemical

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For years, U.S. regulators relied on falsified data provided by Dow Chemical to allow unsafe levels of the chemical chlorpyrifos into American homes, according to a new analysis from University of Washington researchers.

The analysis reexamines work from the 1970s sponsored by Dow and submitted to the Environmental Protection Agency (EPA) to guide the agency in establishing what scientists refer to as a “no-observed-adverse-effect-level” or NOAEL. Such thresholds are used to determine what types of use and at what level a chemical exposure can be allowed and still be considered “safe.”

According to the new analysis, published online July 3 in the journal Environmental International, the inaccurate findings were the result of a chlorpyrifos dosing study conducted by researcher Frederick Coulston and colleagues from the Albany Medical College in the early 1970s for Dow.

The authors of the new paper reexamining that prior work are Lianne Sheppard, Seth McGrew and Richard Fenske of the Department of Environmental and Occupational Health Sciences, School of Public Health at the University of Washington.

While the study was authored by the Coulston group, the analysis was completed by a Dow statistician and concluded that 0.03 mg/kg-day was the chronic NOAEL level for chlorpyrifos in humans. But the new analysis by the University of Washington researchers found that wildly overstated the margin of safety. Had the data been properly analyzed a lower NOAEL of 0.014 mg/kg-day would have been found, they said.

The Coulston study did not undergo peer review but still was used by the EPA for risk assessments throughout much of the 1980′s and 1990′s, the University of Washington researchers reported.

The researchers concluded: “During that period, EPA allowed chlorpyrifos to be registered for multiple residential uses that were later cancelled to reduce potential health impacts to children and infants. Had appropriate analyses been employed in the evaluation of this study, it is likely that many of those registered uses of chlorpyrifos would not have been authorized by EPA. This work demonstrates that reliance by pesticide regulators on research results that have not been properly peer-reviewed may needlessly endanger the public.”

Widely used

Commonly known as the active ingredient in the brand name Lorsban, chlorpyrifos insecticides were introduced by Dow Chemical in 1965 and have been used widely in agricultural settings. The largest agricultural market for chlorpyrifos is corn but the pesticide is also used by farmers growing soybeans, fruit and nut trees, Brussels sprouts, cranberries, and cauliflower, as well as other row crops. Residues of the chemical are commonly found in food. Non-agricultural uses include golf courses, turf, green houses, and utilities.

Despite the science promoted by Dow, independent scientific research has shown mounting evidence of the dangers of chlorpyrifos, particularly to young children. Scientists have found that prenatal exposures to chlorpyrifos are associated with lower birth weight, reduced IQ, the loss of working memory, attention disorders, and delayed motor development.

The American Academy for Pediatrics, which represents more than 66,000 pediatricians and pediatric surgeons, has warned that continued use of the chemical puts developing fetuses, infants, children and pregnant women at great risk.

Chlorpyrifos is so dangerous that the European Food Safety Authority has stated that there is no safe exposure level.

The EPA reached an agreement with Dow in 2000 to phase out all residential uses of the chemical because of research showing the chemical is dangerous to the developing brains of babies and young children. In 2012, chlorpyrifos was banned from use around schools.

In February 2020, after pressure from consumer, medical, scientific groups and in face of growing calls for bans around the world, Corteva AgriScience, a successor corporation to a merger of Dow and DuPont, said it would phase out production of chlorpyrifos. The chemical, however, remains legal for other companies to make and sell.

Human subjects

The study that is the subject of the new paper by the University of Washington researchers was overseen in 1971 by the Albany Medical College’s Institute of Experimental Pathology and Toxicology. The study included 16 healthy adult male inmates from a pool of volunteers at Clinton Correctional Facility, a maximum-security prison in Dannemora, New York.

The volunteers were randomized into four experimental groups, including one control group, whose members received a daily placebo. The members of the three other groups received daily chlorpyrifos treatments at three different doses.  The study took place over 63 days.

The new analysis found several problems with the study, including the omission of eight valid baseline measurements for one of the three treatment groups.

“Such an omission of valid data without justification is a form of data falsification that violates all standard codes of ethical research practice and is classified as outright research misconduct,” the University of Washington researchers concluded.

The researchers said that chlorpyrifos “passed through the regulatory process without much debate,” even though there was “growing evidence that it might pose a health hazard in residential environments.”

“The Coulston Study misled regulators by omitting valid data,” and “may have adversely impacted public health” for several years, the University of Washington paper concludes.

U.S. regulators relied for years on flawed pesticide data provided by Dow Chemical

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For years, U.S. regulators relied on falsified data provided by Dow Chemical to allow unsafe levels of the chemical chlorpyrifos into American homes, according to a new analysis from University of Washington researchers.

The analysis reexamines work from the 1970s sponsored by Dow and submitted to the Environmental Protection Agency (EPA) to guide the agency in establishing what scientists refer to as a “no-observed-adverse-effect-level” or NOAEL. Such thresholds are used to determine what types of use and at what level a chemical exposure can be allowed and still be considered “safe.”

According to the new analysis, published online July 3 in the journal Environmental International, the inaccurate findings were the result of a chlorpyrifos dosing study conducted by researcher Frederick Coulston and colleagues from the Albany Medical College in the early 1970s for Dow.

The authors of the new paper reexamining that prior work are Lianne Sheppard, Seth McGrew and Richard Fenske of the Department of Environmental and Occupational Health Sciences, School of Public Health at the University of Washington.

While the study was authored by the Coulston group, the analysis was completed by a Dow statistician and concluded that 0.03 mg/kg-day was the chronic NOAEL level for chlorpyrifos in humans. But the new analysis by the University of Washington researchers found that wildly overstated the margin of safety. Had the data been properly analyzed a lower NOAEL of 0.014 mg/kg-day would have been found, they said.

The Coulston study did not undergo peer review but still was used by the EPA for risk assessments throughout much of the 1980′s and 1990′s, the University of Washington researchers reported.

The researchers concluded: “During that period, EPA allowed chlorpyrifos to be registered for multiple residential uses that were later cancelled to reduce potential health impacts to children and infants. Had appropriate analyses been employed in the evaluation of this study, it is likely that many of those registered uses of chlorpyrifos would not have been authorized by EPA. This work demonstrates that reliance by pesticide regulators on research results that have not been properly peer-reviewed may needlessly endanger the public.”

Widely used

Commonly known as the active ingredient in the brand name Lorsban, chlorpyrifos insecticides were introduced by Dow Chemical in 1965 and have been used widely in agricultural settings. The largest agricultural market for chlorpyrifos is corn but the pesticide is also used by farmers growing soybeans, fruit and nut trees, Brussels sprouts, cranberries, and cauliflower, as well as other row crops. Residues of the chemical are commonly found in food. Non-agricultural uses include golf courses, turf, green houses, and utilities.

Despite the science promoted by Dow, independent scientific research has shown mounting evidence of the dangers of chlorpyrifos, particularly to young children. Scientists have found that prenatal exposures to chlorpyrifos are associated with lower birth weight, reduced IQ, the loss of working memory, attention disorders, and delayed motor development.

The American Academy for Pediatrics, which represents more than 66,000 pediatricians and pediatric surgeons, has warned that continued use of the chemical puts developing fetuses, infants, children and pregnant women at great risk.

Chlorpyrifos is so dangerous that the European Food Safety Authority has stated that there is no safe exposure level.

The EPA reached an agreement with Dow in 2000 to phase out all residential uses of the chemical because of research showing the chemical is dangerous to the developing brains of babies and young children. In 2012, chlorpyrifos was banned from use around schools.

In February 2020, after pressure from consumer, medical, scientific groups and in face of growing calls for bans around the world, Corteva AgriScience, a successor corporation to a merger of Dow and DuPont, said it would phase out production of chlorpyrifos. The chemical, however, remains legal for other companies to make and sell.

Human subjects

The study that is the subject of the new paper by the University of Washington researchers was overseen in 1971 by the Albany Medical College’s Institute of Experimental Pathology and Toxicology. The study included 16 healthy adult male inmates from a pool of volunteers at Clinton Correctional Facility, a maximum-security prison in Dannemora, New York.

The volunteers were randomized into four experimental groups, including one control group, whose members received a daily placebo. The members of the three other groups received daily chlorpyrifos treatments at three different doses.  The study took place over 63 days.

The new analysis found several problems with the study, including the omission of eight valid baseline measurements for one of the three treatment groups.

“Such an omission of valid data without justification is a form of data falsification that violates all standard codes of ethical research practice and is classified as outright research misconduct,” the University of Washington researchers concluded.

The researchers said that chlorpyrifos “passed through the regulatory process without much debate,” even though there was “growing evidence that it might pose a health hazard in residential environments.”

“The Coulston Study misled regulators by omitting valid data,” and “may have adversely impacted public health” for several years, the University of Washington paper concludes.

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.