The Monsanto Papers: MDL Glyphosate Cancer Case Key Documents & Analysis

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More than 265 lawsuits are pending against Monsanto Co. in U.S. District Court in San Francisco, filed by people alleging that exposure to Roundup herbicide caused them or their loved ones to develop non-Hodgkin lymphoma, and that Monsanto covered up the risks. The cases have been combined for handling as multidistrict litigation under Judge Vince Chhabria. The lead case is 3:16-md-02741-VC. Additionally, at least 1,100 plaintiffs have made similar claims against Monsanto in state courts. The first trial in the Roundup litigation is set for June 18, 2018 in the Superior Court for the County of San Francisco. 

On March 13th, U.S. District Judge Vince Chhabria ruled — over Monsanto’s objections — that certain documents obtained by plaintiffs through discovery could be unsealed. The documents listed below include discovery materials, transcripts of court proceedings, depositions and other case-related items.

As of July 3, 2017, the schedule for adjudication of the MDL litigation is:
Close of Expert Discovery due by 9/22/2017.
Defendant’s Summary Judgment and Daubert Motions due by 10/6/2017.
Plaintiffs’ Cross Motions and opposition due by 10/27/2017.
Science Week – Live testimony from witnesses set for 12/11/2017 through 12/14/2017 09:00 AM.
Summary Judgment and Daubert Hearing set for 12/15/2017 09:00 AM.

A joint committee of the European Parliament held a hearing into the revelations contained in the discovery documents obtained through the MDL litigation on Oct. 11. The agenda can be seen here. More details are here and available here.

Glyphosate: Health Concerns About the Most Widely Used Pesticide

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Updates: Carey Gillam’s book about glyphosate is now available from Island Press. See also Gillam’s presentation about glyphosate to European Parliament committees and the Monsanto Papers archive of documents

Glyphosate is a synthetic herbicide patented in 1974 by the Monsanto Company, and now manufactured and sold by many companies in hundreds of products around the world. Glyphosate is best known as the active ingredient in Monsanto’s Roundup branded herbicides.

Here are some key facts about glyphosate:

Most Widely Used Pesticide 

According to a February 2016 study in Environmental Sciences Europe, glyphosate is the most widely used pesticide. “In the U.S., no pesticide has come remotely close to such intensive and widespread use,” according to the study. Findings include:

  • Americans have applied 1.8 million tons of glyphosate since its introduction in 1974.
  • Worldwide 9.4 million tons of the chemical has been sprayed on fields – enough to spray nearly half a pound of Roundup on every cultivated acre of land in the world.
  • Globally, glyphosate use has risen almost 15-fold since so-called “Roundup Ready,” genetically engineered glyphosate-tolerant crops were introduced in 1996.

Cancer Concerns

In 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) classified glyphosate as “probably carcinogenic to humans.” The team of international scientists found there was a particularly strong link between glyphosate and non-Hodgkin lymphoma.

On March 28, 2017, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment confirmed that it would add glyphosate to California’s Proposition 65 list of chemicals known to cause cancer. Monsanto sued to block the action but the case was dismissed.

The EPA convened a Scientific Advisory Panel (SAP) in December 2016 to receive expert feedback from independent scientists about the assessment and the conclusion contained in the issue paper. The panel members were divided in their assessment of EPA’s work, with some finding the EPA erred in how it evaluated certain research and reached its conclusion. The EPA’s final report on glyphosate is scheduled to be released before the end of 2017.

According to an internal EPA document, two EPA departments disagreed with each other about glyphosate safety. The Office of Research and Development’s epidemiologists said the Office of Pesticide Programs had not followed proper agency protocol in determining glyphosate was “not likely to be carcinogenic to humans.”

The European Food Safety Authority and the European Chemicals Agency have said glyphosate is not likely to be carcinogenic to humans. A March 2017 report by environmental and consumer groups argues that regulators relied improperly on research that was directed and manipulated by the chemical industry.

The World Health Organization Joint Meeting on Pesticide Residues also cleared glyphosate as unlikely to pose a risk to humans, although that group was tarnished by conflicts of interest regarding ties to the International Life Sciences Institute, a food industry front group.

Cancer Lawsuits

More than 50 lawsuits against Monsanto Co. are pending in U.S. District Court in San Francisco, filed by people alleging that exposure to Roundup herbicide caused them or their loved ones to develop non-Hodgkin lymphoma, and that Monsanto covered up the risks. The litigation has been consolidated as multidistrict litigation (MDL) for more efficient processing. Several hundred similar actions are pending in state courts.

In March 2017, the federal court judge overseeing the MDL unsealed some internal Monsanto documents that raised new questions about Monsanto’s influence on the EPA process and about the research regulators rely on. The documents suggest that Monsanto’s long-standing claims about the safety of glyphosate and Roundup do not necessarily rely on sound science as the company asserts, but on efforts to manipulate the science.

U.S. Right to Know is posting key documents and analysis from the litigation.

Endocrine Disruption and Other Health Concerns

Some research has also indicated that glyphosate may be an endocrine disruptor; has been linked to liver disease, birth defects and reproductive problems in laboratory animals; and may kill beneficial gut bacteria and damage the DNA in human embryonic, placental and umbilical cord cells.

Many scientists have raised concerns about the health risks of glyphosate:

GMO Connection

Most genetically modified (GMO) crops – some 94% of soy and 89% of corn grown in the U.S., according to USDA data – are “herbicide tolerant” crops that have been genetically engineered to withstand glyphosate exposure.

Globally, glyphosate use has risen almost 15-fold since so-called “Roundup Ready” GMO crops were introduced in 1996, according to a study by Charles Benbrook in Environmental Sciences Europe.

Desiccation 

Farmers also use glyphosate on non-GMO crops such as wheat, barley, oats, and lentils to dry down the crop ahead of harvest in order to accelerate the harvest. This practice, known as desiccation, may be a significant source of dietary exposure to glyphosate, according to Benbrook.

Glyphosate Found in Food: U.S. Drags Its Feet on Testing

The USDA has quietly dropped a plan to start testing food for residues of glyphosate. Internal agency documents obtained by U.S. Right to Know show the agency had planned to start testing over 300 samples of corn syrup for glyphosate on April 1, 2017. Now the agency says the plan is dead. The U.S. Food and Drug Administration began a limited testing program of its own in 2016, but the effort was fraught with controversy and internal difficulties and the program was suspended in September 2016. Both agencies have programs that annually test foods for pesticide residues but both have routinely skipped testing for glyphosate.

Before the suspension, one FDA chemist found alarming levels of glyphosate in many samples of U.S. honey, levels that were technically illegal because there have been no allowable levels established for honey by the EPA. Here are the most recent findings about glyphosate levels in food:

  • Sept. 21, 2016: FDA found glyphosate in US honey at double the levels allowed in the EU.
  • Nov. 3, 2016: FDA chemist found glyphosate in honey in Iowa at 10X higher levels than allowed in EU.

Pesticides in Our Food: Where’s the Safety Data?

USDA data from 2016 shows detectable pesticide levels in 85% of more than 10,000 foods sampled, everything from mushrooms to grapes to green beans. The government says there are little to no health risks, but some scientists say there is little to no data to back up that claim. See: New Data on Pesticides in Food Raises Safety Questions

What Killed Jack McCall? A Farmer Dies; A Case Against Monsanto Takes Root

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By Carey Gillam

CAMBRIA, Calif.- Standing on the ridge overlooking her central California farm, new widow Teri McCall sees her husband Jack nearly everywhere. There, atop the highest hill, is where the couple married in 1975- two self-described “hippies’ who knew more about how to surf than farm. And over there, surrounded by the lemon, avocado and orange trees Jjack mccall copyack planted, sits the 800-square-foot house the young Vietnam veteran built for his bride and a family that grew to include two sons and a daughter. Solar panels Jack set up in a sun-drenched stretch of grass power the farm’s irrigation system.

And down there, clasped in the cusp of the velvet green valley sits the century-old farmhouse Jack and Teri eventually made their permanent home. Jack installed a stained glass window featuring a heart and flowers over the front door.

“Literally hundreds of times a day, something reminds me of him,” McCall says, as she and a visitor strolled through the orchards on a recent sunny spring morning. “That’s part of why it’s so hard to believe… I can never see him again.”

Anthony ‘Jack’ McCall, 69, died Dec. 26 after a painful and perplexing battle with non-Hodgkin lymphoma. The loss is certain, fixed forever into his family’s heartbreak. But questions about why and how he was stricken – a man who never smoked, stayed fit and had no history of cancer in his family – are part of what some legal experts see as a potential landmark legal claim against one of the world’s largest agrichemical companies, Monsanto Co.

McCall shunned pesticide use on his farm, except for the herbicide called Roundup – marketed by Monsanto as having extremely low toxicity. He used Roundup regularly, spraying it himself around the farm to drive back worrisome weeds. He even recommended Roundup to friends, telling them it was supposed to be much safer than alternatives on the market, and touting its effectiveness.

But now in his death, McCall is one of several plaintiffs in more than a dozen lawsuits that claim the active ingredient in Roundup – a chemical called glyphosate – gave them cancer, and that Monsanto has long known glyphosate poses “significant risks to human health, including a risk of causing cancer.”

The lawsuits, brought by plaintiffs in California, Florida, MissouriDelaware, Hawaii,and elsewhere over the last several months, claim Monsanto has hidden evidence, and manipulated regulators and the public into believing in the safety of glyphosate, which annually brings in about $5 billion, or a third of total sales, for the agribusiness giant. Like McCall, many farmed, or worked in agricultural jobs in which they regularly were using or exposed to glyphosate.

The claims come at a critical time for Monsanto and its signature product as regulators in the United States and other countries evaluate whether or not to continue to allow glyphosate herbicides. Last year the World Health Organization’s cancer experts classified glyphosate as a probable human carcinogen. That team, the International Agency for Research on Cancer (IARC), said glyphosate shows a “positive association” for non-Hodgkin lymphoma. 

The outcomes of the legal battle and the regulatory reviews could have broad implications. Glyphosate is the most widely used herbicide on the planet, sprayed on fields for row crops like corn, soybeans and wheat, as well as a variety of fruits, nuts and vegetable crops such as almonds, apples, cherries and oranges.

That ubiquitous role played by glyphosate means the litigation, plaintiffs’ lawyers say, marks the beginning of a potential wave of legal actions against Monsanto. Teams of attorneys have been criss-crossing the country lining up potential plaintiffs who they say will likely number in the hundreds and possibly thousands. It’s a time-tested practice by plaintiffs’ attorneys who have brought similar mass actions in the past against tobacco, pharmaceutical and chemical industries.

“Monsanto has deliberately concealed or suppressed information about the dangers of its product,” said environmental and chemical pollution attorney Robert F. Kennedy Jr., who is assisting in litigating glyphosate cases. “This is big. It’s on every farm in the world.”

Kennedy predicts glyphosate liability litigation will become as widespread as has been decades of litigation over asbestos, which is seen in legal circles as the longest-running mass tort action in U.S. history. Asbestos was used for years as a safe and effective flame retardant in the construction industry but has been tied to lung diseases and cancers, and spawned hundreds of millions of dollars in legal claims.

The glyphosate litigation partly mirrors courtroom battles Monsanto has been fighting for years involving the polychlorinated biphenyls, or PCBs it once manufactured. Plaintiffs in those cases also claim PCBs caused them to fall ill while Monsanto hid the risks. Monsanto claims plaintiffs cannot definitively link illnesses to PCB exposure.

AMONG THE SAFEST OPTIONS
Patented by Monsanto and commercialized in 1974, glyphosate herbicide has long been considered among the safest pesticide options on the market. The weed-killer came off patent in 2000 and is now used in more than 700 products around the world, beloved by farmers, homeowners, and groundskeepers. The chemical is the world’s most widely used herbicide with an estimated 1.8 billion pounds applied in 2014, up 12-fold from 1994, according to recently published research.

But as use has grown, concerns about safety have also mounted. Residues have been documented by public and private researchers in waterways, air, food and in human bodily fluids. Several scientific studies tied the chemical to cancers and other health problems before the March 2015 classification by IARC.

Lawyers for plaintiffs in the glyphosate cases say that among the evidence that glyphosate’s toxicity has long been known is an EPA memo detailing how glyphosate was classified by agency scientists as a possible human carcinogen in 1985 before classified in 1991 as a having “evidence of non-carcinogenicity” for humans. The classification was changed despite the fact that some peer review members did not concur. The lawsuits also cite evidence of fraud at laboratories used by Monsanto to perform toxicology studies of glyphosate, and point to fraud convictions of executives at those labs.

St. Louis-based Monsanto, a global agrichemical and seed powerhouse, cites its own evidence to counter both the validity of the allegations in the lawsuits, as well as the IARC findings. Last year, the company hired a team of experts to review the safety of glyphosate, and said that team found no cancer links. 

“Comprehensive long-term toxicological studies repeated over the last 30 years have time and again demonstrated that glyphosate is unlikely to pose a cancer risk in humans,” Monsanto states on its website. ‘Regulatory authorities and independent experts around the world have reviewed numerous long-term/carcinogenicity and genotoxicity studies and agree that there is no evidence that glyphosate… causes cancer, even at very high doses.”

Monsanto attorneys have been seeking to dismiss and/or delay several cases thus far filed, asserting that federal law and approvals by the Environmental Protection Agency for labels on Roundup herbicide products protect Monsanto from the claims in the lawsuits. In recent arguments in U.S. District Court in Northern California, for example, lawyers for Monsanto argued that “EPA repeatedly has concluded that glyphosate is not a carcinogen.” But in April a federal judge in California ruled that Monsanto was not protected from liability by the EPA registration and approved labels.

In a Missouri case that Monsanto also was unable to get dismissed, discovery is starting, and plaintiffs’ lawyers are eagerly awaiting what they hope will be a treasure trove of evidence for their clients.

The legal claims come at the same time that European and U.S. regulators are conducting their own assessments of the safety of glyphosate and considering restrictions, processes that have become fraught with infighting and accusations of bias from both fans and foes of glyphosate. The European Food Safety Authority (EFSA) said in November that evidence shows glyphosate is unlikely to be carcinogenic. But the European Parliament has said the herbicide use should be reined in with a ban on non-professional use and around parks and playgrounds because of the health worries.

The EPA was due to release a fresh risk assessment on glyphosate nearly a year ago, but has stalled the process amid the uproar. And in an odd twist to the saga, on April 29, the agency posted an internal document to its website, showing that the EPA’s cancer assessment experts have determined that glyphosate is “Not Likely to be Carcinogenic to Humans.”

On May 2, EPA withdrew the memo from its website and said it was not supposed to have been released because the cancer assessment is ongoing. But Monsanto heralded the release of the document as proof of what it has been saying about glyphosate’s safety.

Wall Street is keeping a wary eye on the litigation. But generally market watchers care less about Monsanto’s risk from potential liability payouts and more about any potential long-term revenue hit if regulators were to restrict or ban glyphosate, said Piper Jaffray analyst Brett Wong, who tracks Monsanto’s business strategies and financial health. The courtroom battles could influence regulators, he said.

“There are obviously a lot of lawsuits,” Wong said. “They aren’t intrinsic to impacting their business but there is always some sentiment pressure on investors. If it were to impact the regulatory structure and glyphosate was banned… that could obviously have an impact.”

Legal experts with experience defending the chemical industry are watching the cases with interest, and many say given a lack of regulatory support for the cancer linkage, plaintiffs’ attorneys have an uphill climb to make such claims stick.

“The evidence to support the claims isn’t there, said one prominent lawyer, declining to be quoted by name. “It’s not mothers’ milk by any means. I wouldn’t mix it in my drink, but it’s one of the safest chemicals out there,” he said.

Attorney Brent Wisner, who is representing the McCall family, said he is confident in the strength of the evidence against Monsanto. “It’s going to be a fairly large litigation when it’s all said and done. We’re confident we’ll be able to show that Monsanto controlled research and suppressed science,” he said.

Back in Cambria, Jack McCall’s son Paul McCall is running the farm in his father’s place. His eyes tear quickly when asked about his father’s diagnosis in September 2015 and death only three months later, the day after Christmas. He doesn’t want to talk about the lawsuit, other than to say he has no use for glyphosate now, and wants to warn others away from it.

“This is a battle that has to be fought,” he said.

How big and how bloody the litigation becomes is still an open question. The shouting from both sides of the issues is getting louder with each passing day. But the deep questions about the safety of this herbicide deserve serious and scientific review as the answers hold implications for our food production, our environment and the health of our families well into the future.

This article originally appeared in Huffington Post

Carey Gillam is a veteran former Reuters journalist, current freelance writer/editor and research director for U.S. Right to Know, a food industry research group