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

Print Email Share Tweet

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

Print Email Share Tweet

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

Print Email Share Tweet

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.

Roundup cancer attorney pleads guilty to extortion attempt

Print Email Share Tweet

A Virginia lawyer who helped represent the first Roundup cancer plaintiff to take Monsanto to trial pleaded guilty on Friday to trying to extort $200 million from a chemical compound supplier to Monsanto.

Timothy Litzenburg, 38, admitted to a scheme in which he and another lawyer threatened to inflict substantial “financial and reputational harm” on the supplier unless that company paid the two attorneys $200 million disguised as a “consulting agreement.”

According to the U.S. Department of Justice, Litzenburg allegedly told the company that if they paid the money, he was willing to “take a dive” during a deposition, intentionally undermining the prospects for future plaintiffs to try to sue.

Litzenburg was charged with one count each of attempted extortion, conspiracy and transmission of interstate communications with intent to extort. He pleaded guilty to one count of transmitting interstate communications with the intent to extort.

Lawyer Daniel Kincheloe, 41, pleaded guilty to the same charge for participating in the scheme.  The men are scheduled to be sentenced on Sept. 18 in U.S. District Court for the Western District of Virginia.

“This is a case where two attorneys blew well past the line of aggressive advocacy and crossed deep into the territory of illegal extortion, in a brazen attempt to enrich themselves by extracting millions of dollars from a multinational company,” Assistant Attorney General Brian A. Benczkowski said in a statement. He said that the plea shows that “when crimes are committed, members of the bar, like all members of the public, will be held accountable for their actions.”

Litzenburg was one of the attorneys for Dewayne “Lee” Johnson leading up to Johnson’s 2018 trial against Monsanto, which resulted in a $289 million jury award in Johnson’s favor. (The judge in the case lowered the verdict and the case is currently under appeal.)

The trial was the first of three that have taken place against Monsanto over allegations that the company’s glyphosate-based herbicides such as Roundup cause non-Hodgkin lymphoma. Monsanto, and its German owner Bayer AG, have lost all three trials to date but are appealing the verdicts.

Though Litzenburg had helped prepare Johnson for trial, he was not allowed to participate during the actual event because of concerns about his behavior held by The Miller Firm, which was his employer at the time.

The Miller firm subsequently fired Litzenburg and filed a lawsuit in early 2019 alleging Litzenburg engaged in self-dealing, and “disloyal and erratic conduct.” Litzenburg responded with a counter-claim. The parties  negotiated a confidential settlement.

The criminal complaint against Litzenburg did not name the company Litzenburg tried to extort, but said that he contacted the company in September of  2019 year stating that he was preparing a lawsuit that would allege the company supplied chemical compounds used by Monsanto to create Roundup and that the company knew the ingredients were carcinogenic but had failed to warn the public.

According to the federal charges, Litzenburg told a lawyer for the company he was trying to extort that the company should enter into a “consulting arrangement” with him so as to create a  conflict of interest that would prevent him from filing the threatened litigation.

Litzenburg wrote in the email that the $200 million consulting agreement for himself and an associate was “a very reasonable price,” according to the criminal complaint.

Federal investigators recorded a phone call with Litzenburg discussing the $200 million he was seeking, the complaint states. Litzenburg was allegedly recorded as saying: “The way that I guess you guys will think about it and we’ve thought about it too is savings for your side. I don’t think if this gets filed and turns into mass tort, even if you guys win cases and drive value down… I don’t think there’s any way you get out of it for less than a billion dollars. And so, you know, to me, uh, this is a fire sale price that you guys should consider…”

Litzenburg claimed to be representing roughly 1,000 clients suing Monsanto over Roundup cancer causation allegations at the time of his arrest last year.

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

Print Email Share Tweet

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

Roundup cancer plaintiffs eagerly await settlement news

Print Email Share Tweet

Thousands of cancer patients and their families around the United States were notified this week that a comprehensive settlement of their claims against the former Monsanto Co. should be announced before the end of the month.

Though specific settlement amounts for specific plaintiffs are still to be determined, groups of plaintiffs have been told to expect details of a sweeping financial deal to be publicly announced before a June 30 deadline set for completing the year-long negotiations. All allege they developed non-Hodgkin lymphoma after exposure to Monsanto’s glyphosate-based herbicides, such as Roundup. They additionally allege that the company knew of scientific evidence showing cancer risks associated with its products, but worked to suppress the information to protect its profits.

Lawyers for Monsanto owner Bayer AG and lawyers representing more than 50,000 of the plaintiffs have been engaged in contentious, start-and-stop discussions about a settlement for several months, frustrating families who are struggling financially and emotionally with the strains of fighting cancer.

Many plaintiffs have lost jobs and homes as they deal with costly cancer treatments and some have died while waiting for their cases to be resolved, court records show. Notification of the death of one such plaintiff was made to the federal court in San Francisco on June 1.

Many of the lead law firms with large caseloads have agreed to the terms of a deal that calls for $8 billion-$10 billion to be paid by Bayer in exchange for an agreement that those firms will not file new cancer claims against the company, according to sources close to the litigation.

The amount of money each plaintiff gets will depend upon several factors. The settlements are expected to be structured so they will be tax-free for the plaintiffs.

Some law firms with Roundup plaintiffs have yet to finalize a deal, and settlement meetings were still being held last week, including with the Louisiana-based firm of Pendley, Baudin & Coffin, according to sources close to the litigation.

Bayer spokesman Chris Loder would not confirm the timing or terms of any announcement, saying only that the company had made progress in the negotiations but would “not speculate about settlement outcomes or timing.”

He said any resolution has to be “financially reasonable” and provide “a process to resolve potential future litigation.”

Bayer, which bought Monsanto in June of 2018, has been seeking to put an end to the mass litigation that has driven down the company’s stock, spurred investor unrest, and thrust questionable corporate conduct into a public spotlight.  The first three trials led to three losses for Monsanto and jury awards of more than $2 billion, though trial judges later sharply reduced the awards. Monsanto appealed each of the three losses and is now awaiting an appellate ruling on the first case – Johnson v. Monsanto – after a June 2 oral argument. 

Despite the settlement talks, court proceedings have been continuing on multiple cases. A flurry of lawsuits were recently transferred from state courts into the federal multidistrict Roundup litigation in the U.S. District Court for the Northern District of California in San Francisco. And lawyers for Bayer have been busily filing their answers to the lawsuits.

In the city of St. Louis, Mo., Monsanto’s longtime home-town, the case of Timothy Kane v. Monsanto has a status hearing set for June 15 and a jury trial set to start June 29.  And though it appears very unlikely the case will proceed, on Wednesday lawyers for the chemical giant filed a motion seeking to exclude testimony of one of the witnesses for the plaintiffs.

.

EPA thumbs nose at court order, says farmers can still use illegal dicamba herbicides

Print Email Share Tweet

(UPDATES with comment from BASF)

The Environmental Protection Agency on Monday declared it would not immediately honor a court ruling handed down last week that banned certain herbicides made by three of the world’s largest chemical companies.

The move by the EPA amounts to a generous gift to BASF, Bayer and Corteva Agrisciences whose dicamba herbicides were deemed by the court to have been approved by the EPA illegally. The court specifically said in its order issued last week 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.

But the EPA announced Monday that it was issuing a “cancellation order” that would give farmers until July 31 to use existing stocks of Bayer’s Xtendimax, BASF’s Engenia, and Corteva’s FeXapan.

The ruling by the U.S. Court of Appeals for the Ninth Circuit found that the EPA made multiple errors in approving the dicamba products and came in response to a petition brought by the National Family Farm Coalition, Center for Food Safety, Center for Biological Diversity, and Pesticide Action Network North America.

The Center for Food Safety (CFS), whose lawyers argued the case for petitioners, said in a statement that the EPA’s action was “disingenuous” and “ignores the well-documented and overwhelming evidence of substantial drift harm to farmers from another disastrous spraying season.” The EPA action also ignores the risks dicamba poses to hundreds of endangered species, CFS said.

“The Trump administration is again showing it has no regard for the rule of law. All users that continue to not seek alternatives should be on notice that they are using a harmful, defective, and unlawful product. We will bring the EPA’s failure to abide by the Court’s order to the Court as expeditiously as possible,” CFS said.

U.S. Secretary of Agriculture Sonny Perdue last week urged the EPA to figure out a way around the court ruling, echoing comments by Bayer, BASF and Corteva that called dicamba herbicides important “tools” for farmers growing genetically engineered soybean and cotton.

The EPA said in deciding to allow farmers to continue to use dicamba through the end of July it was responding to “numerous unsolicited phone calls and emails” telling the agency “there is a real concern and potential for devastation to cotton and soybean crops that could result in a crisis for the industry.”

The EPA did not acknowledge the scores of farmers growing crops other than dicamba-tolerant soybeans and cotton who have suffered crop losses from dicamba drift and fear another summer of crop damage.

Farmers have been using dicamba herbicides for more than 50 years but traditionally avoided applying the herbicide during hot summer months, and rarely if ever over large swaths of land due to the well-known propensity of the chemical to drift far from intended target areas where it could damage crops, gardens, orchards, and shrubs.

Monsanto, which was bought by Bayer in 2018, upended that restraint when it launched dicamba-tolerant soybean and cotton seeds a few years ago, encouraging farmers to spray new formulations of dicamba “over the top” of these genetically engineered crops during warm-weather growing months.

Monsanto’s move to create the dicamba-tolerant crops came after its glyphosate-tolerant crops and widespread spraying of glyphosate created an epidemic of weed resistance across U.S. farmland.

Farmers, agricultural scientists and other experts warned Monsanto and the EPA that introducing a dicamba-tolerant system would not only create more herbicide resistance but would lead to devastating damage to crops that are not genetically engineered to tolerate dicamba.

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 were proven false amid widespread complaints of dicamba drift damage in recent years. More than one million acres of dicamba crop damage was reported last year in 18 states, the court noted.

In February, a unanimous jury awarded a Missouri peach farmer $15 million in compensatory damages and $250 million in punitive damages to be paid by Bayer and BASF for dicamba damage to his property.

In a statement issued after the EPA announcement, BASF  said it supported the EPA’s decision to allow the continued use of existing stocks of BASF’s Engenia herbicide through July 31, but said “additional clarity and flexibility” was required.  The company said it had immediately suspended selling and shipping Engenia herbicide after last week’s ruling. 

The company said it  will continue to pursue re-registration of Engenia with the EPA and is assessing its options to pursue legal remedies to challenge the court order.

Appeals court hears arguments over Monsanto’s first Roundup trial loss

Print Email Share Tweet

A California jury decision blaming a Monsanto herbicide for a school groundskeeper’s cancer was deeply flawed and incompatible with the law, a Monsanto attorney told a panel of appellate judges on Tuesday.

The company’s glyphosate-based herbicides – popularly known as Roundup – have the full backing of the Environmental Protection Agency (EPA) and “regulators around the world,” attorney David Axelrad told judges with the California Court of Appeal First Appellate District.

Axelrad said Monsanto had no duty to warn anyone about an alleged cancer risk given the regulatory consensus that its weed killers are safe.

It is “fundamentally unfair to hold Monsanto liable and punish it for a product label that accurately reflects not only EPA determination but a worldwide consensus that glyphosate is not carcinogenic,” he argued in the hour-long hearing. The proceeding was held by telephone because of COVID-19 restrictions on courthouse access.

Associate Justice Gabriel Sanchez questioned the validity of that argument:  “You have animal studies… mechanism studies, you have control case studies,” he said, addressing Monsanto’s attorney. “There are a  number of, it seems, published peer reviewed studies… that suggest a statistically significant relationship between glyphosate and lymphoma. So I don’t know that I would agree with you that it has unanimous consensus. Certainly the regulatory agencies seem to be on one side. But there is a lot of other evidence on the other. ”

The appeal stems from the 2018 jury decision in San Francisco Superior Court that ordered Monsanto to pay $289 million to Dewayne “Lee” Johnson, including $250 million in punitive damages.

The trial judge in the Johnson case lowered the award to $78.5 million. But Monsanto appealed the verdict, asking the court to either reverse the trial decision and enter a judgment for Monsanto or reverse and remand the case for a new trial or at least sharply reduce the damages.  Johnson cross-appealed seeking reinstatement of the full jury award.

Johnson is one of tens of thousands of people from around the United States who have sued Monsanto alleging Roundup and other glyphosate-based herbicides made by the company cause non-Hodgkin lymphoma and that the company spent decades covering up the risks.

Johnson gained “preference” status because doctors said his life expectancy was short and that he would likely die within 18 months of the trial. Johnson has confounded the doctors and remains alive and undergoing regular treatments.

Monsanto’s loss to Johnson marked the first of three Roundup trial losses for the company, which was acquired by Germany’s Bayer AG in June 2018 just as the Johnson trial started.

The jury in the Johnson case specifically found – among other things – that Monsanto was negligent in failing to warn Johnson of the cancer risk of its herbicides. But Monsanto argues that the verdict was flawed because of exclusion of key evidence and what the company’s attorneys call the “distortion of reliable science.”

If the appeals court does not order a new trial, Monsanto asked that the judges at least reduce the portion of the jury award for “future noneconomic damages” from $33 million to $1.5 million and to wipe out the punitive damages altogether.

Johnson’s trial attorneys had argued that he should get $1 million a year for pain and suffering over the 33 additional years that he would likely live if he had not gotten cancer.

But Monsanto’s attorneys have said Johnson should get only $1 million a year for pain and suffering during his actual life expectancy or $1.5 million for an 18-month expected future span.

On Tuesday, Axelrad reiterated that point: “Sure a plaintiff can recover during his lifetime for the pain and suffering that might be occasioned by knowing that he has a shortened life expectancy,” he told the judicial panel. “But you cannot recover for pain and suffering that is unlikely to occur in years where you will no longer be living and that is what the plaintiff received in this case.”

Axelrad told the justices that the company had been falsely painted as engaging in misconduct but in fact had properly followed the science and the law. He said, for example, though Johnson’s attorney had accused Monsanto of ghost-writing scientific papers, company scientists had only made “editorial suggestions” for several papers published in the scientific literature.

“Whether or not Monsanto could have been more forthcoming in identifying its involvement in those studies the bottom line is that those studies produced no false or misleading information and there is no indication that any of the authors of those studies would have changed their opinion had Monsanto not provided editorial comment,” he said.

Axelrad said there was no malice and no basis for punitive damages to be leveled against Monsanto. The company’s defense of its glyphosate-based herbicides over the years has been “entirely reasonable and in good faith,” he said.

“There is absolutely no evidence that Monsanto distributed false, misleading or incomplete information, no evidence that its actions prevented the dissemination of information to regulatory agencies needed to review the scientific evidence, no evidence that its actions compromised the ultimate regulatory decision making and no evidence that Monsanto refused to conduct a test or study in order to conceal information about a risk of harm or prevent the discovery of new information about the science of glyphosate,” he said.

Johnson attorney Mike Miller said that Monsanto’s lawyers were attempting to get the appellate court to retry the facts of the case, which is not its role.

“Monsanto misunderstands the appellate function. It is not to reweigh the facts. The facts that were just argued by Monsanto’s counsel were rejected thoroughly by the jury and rejected by the trial judge…” Miller said.

The appellate court should uphold the damages the jury awarded, including the punitive damages,  because Monsanto’s conduct surrounding the science and safety of its glyphosate herbicides was “egregious,” Miller said.

The evidence presented at the Johnson trial showed Monsanto engaged in the ghostwriting of scientific papers while it failed to adequately test its formulated glyphosate herbicides for carcinogenicity risks. The company then initiated “unprecedented” attacks on the credibility of  international cancer scientists who classified glyphosate as a probable human carcinogen in 2015, he told the judicial panel.

“In punitive damages, as you assess the reprehensibility of Monsanto you must factor in the wealth of Monsanto. And the award must be enough to sting,” said Miller. “Under California law unless it changes the conduct it hasn’t fit the purpose of punitive damages.”

The appellate panel has 90 days to issue a ruling.

Fresh talk of a settlement between Bayer and Roundup cancer patients

Print Email Share Tweet

There was renewed talk of a potential settlement this week between Bayer AG and tens of thousands of cancer patients as a key court hearing looms next week.

According to a report in Bloomberg, lawyers for Bayer have reached verbal agreements with U.S. lawyers representing at least 50,000 plaintiffs who are suing Monsanto over claims that Roundup and other Monsanto herbicides caused the plaintiffs to develop non-Hodgkin lymphoma.

The details as reported by Bloomberg appear to be mostly unchanged from prior verbal agreements between Bayer and plaintiffs’ attorneys that fell apart during the Coronavirus-related courthouse closings. With the courthouses still closed, trial dates have been postponed, taking the pressure off Bayer.

But a new pressure point looms with next week’s hearing in the appeal of the first Roundup cancer trial. The California Court of Appeal First Appellate District is set to hear oral arguments on cross-appeals in the case of Johnson v Monsanto  on June 2.

That case, which pitted California groundskeeper Dewayne “Lee” Johnson against Monsanto, resulted in a $289 million damage award for Johnson in August 2018. The jury found not only that Monsanto’s Roundup and related glyphosate-based brands presented a substantial danger to people using them, but that there was “clear and convincing evidence” that Monsanto’s officials acted with “malice or oppression” in failing to adequately warn of the risks.

The trial judge in the Johnson case later lowered the damages to $78.5 million. Monsanto appealed even the reduced award, and Johnson cross-appealed seeking reinstatement of the full jury award.

In appealing the verdict, Monsanto asked the court to either reverse the trial decision and enter a judgment for Monsanto or reverse and remand the case for a new trial. At the very least, Monsanto asked the appeals court to reduce the portion of the jury award for “future noneconomic damages” from $33 million to $1.5 million and to wipe out the punitive damages altogether.

The appeals court judges gave an early hint about how they were leaning on the case, notifying lawyers for the two sides that they should be prepared to discuss the question of damages in the June 2 hearing. Plaintiffs’ attorneys have taken that as an encouraging sign that the judges may not be planning to order a new trial.

Under the terms of the settlement that has been discussed for the last several months, Bayer would pay out a total of $10 billion to bring closure to cases held by several large firms, but would not agree to put warning labels on its glyphosate-based weed killers, as had been demanded by some of the plaintiffs’ attorneys.

The settlement would not cover all of the plaintiffs with pending claims. Nor would it cover Johnson or the other three plaintiffs who already won their claims at trial. Monsanto and Bayer have appealed all the trial losses.

Lawyers at the major firms involved in the litigation declined to discuss the current situation.

Bayer officials have denied there is any scientific evidence linking glyphosate herbicides to cancer, but investors have been pushing for a settlement to resolve the litigation. It would be beneficial to Bayer to settle the cases before any adverse ruling by the appellate court, which could further rattle the company’s shareholders. Bayer bought Monsanto in June of 2018. Following the Johnson trial loss in August 2018, the company’s share price plummeted and has remained under pressure.

Frustrated Plaintiffs

The first lawsuits in the Roundup cancer litigation were filed in late 2015, meaning many plaintiffs have been waiting years for resolution. Some plaintiffs have died while they waited, with their cases now being carried forward by family members frustrated at the lack of progress in bringing cases to a close.

Some plaintiffs have been making video messages directed at Bayer executives, calling for them to agree to settlements and to make changes to warn consumers about potential cancer risks of glyphosate-based herbicides such as Roundup.

Vincent Tricomi, 68, is one such plaintiff. In the video he made, which he shared with US Right to Know, he said he has undergone 12 rounds of chemotherapy and five hospital stays fighting his cancer. After achieving a temporary remission, the cancer recurred earlier this year, he said.

“There are so many like me who are suffering and need relief,” said Tricomi.  Watch his video message below:

Appeals court focused on damages question ahead of Johnson v. Monsanto hearing

Print Email Share Tweet

A California appeals court looks poised to issue a ruling that would uphold the first U.S. trial victory involving allegations that Monsanto’s Roundup weed killer causes cancer.

The California Courts of Appeal First Appellate District on Wednesday notified lawyers for plaintiff Dewayne “Lee” Johnson and legal counsel for Monsanto that they should be prepared to focus on the question of damages awarded in the case at a hearing scheduled for June 2.

The fact that the court is showing it is interested in discussing what amount of damages are appropriate rather than issues pertaining to Monsanto’s request to overturn the trial loss entirely bodes well for the plaintiff’s side, said legal observers.

Monsanto August 2018 loss to Johnson, a California school groundskeeper, marked the first of three Roundup trial losses for the company, which was acquired by Germany’s Bayer AG nearly two years ago. The jury in the Johnson case found that Monsanto was negligent in failing to warn Johnson of the cancer risk of its herbicides and awarded Johnson $289 million in damages, including $250 million in punitive damages. The trial judge later lowered the award to $78.5 million. But the loss sent Bayer’s shares spirally lower and stoked investor unrest that has persisted as the number of additional Roundup cancer claims filed against Monsanto have grown.

In appealing the verdict, Monsanto asked the court to either reverse the trial decision and enter a judgment for Monsanto or reverse and remand the case for a new trial. Monsanto argued that the verdict was flawed because of exclusion of key evidence and the “distortion of reliable science.” If nothing else,  Monsanto asked the appeals court to reduce the portion of the jury award for “future noneconomic damages” from $33 million to $1.5 million and to wipe out the punitive damages altogether.  Monsanto’s argument on reducing future non-economic damages is based on the company’s position that Johnson is likely to die soon and thus will not suffer long-term future pain and suffering.

Johnson cross-appealed seeking reinstatement of the full jury award of $289 million.

Ahead of the hearing on the matter, the judicial panel said this: “The parties should be ready to address the following issue at oral argument, currently scheduled for June 2, 2020. Assume that this court agrees with Monsanto Company that the award of future noneconomic damages should be reduced. If the court directs such a reduction, should it also reduce the award of punitive damages to maintain the trial court’s 1:1 ratio of compensatory damages to punitive damages?”

In a separate matter, the court last month said it was rejecting an application by the California Attorney General to file an amicus brief on Johnson’s side.

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.

In its appeal, Monsanto argued that jurors were acting on emotion rather than scientific fact and “that there is no evidence that Monsanto had actual knowledge that its glyphosate-based herbicides cause cancer. Nor could there be, when the scientific consensus, consistently accepted by EPA and other regulators around the world, contradicts that conclusion. It was not malicious for the regulators to reach this judgment, and it was not malicious for Monsanto to share their view of the science.”

Tens of thousands of plaintiffs have filed suit 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.

Bayer and lawyers for more than 50,000 plaintiffs have been trying to negotiate a national settlement for the last year but Bayer recently backed away from some already negotiated settlement amounts. With courthouses closed around the country, the plaintiffs’ attorneys have lost the near-term leverage they had when multiple new trials were set to take place this summer and fall.