Monsanto Influence Over Roundup Regulation, Science, Revealed In New Documents

New documents uncovered as part of ongoing litigation over Roundup highlight the extent to which Monsanto attempted to influence regulators and the scientific community about their controversial glyphosate-based weedkiller, which has now been linked to reports of non-Hodgkins lymphoma. 

There are hundreds of Roundup lawsuits pending against Monsanto, each involving similar allegations that inadequate warnings were provided about the risk of cancer for farmers, landscapers, agricultural workers and other customers regularly exposed to high levels of the weedkiller.

The Roundup litigation emerged after the World Health Organization’s International Agency for Research on Cancer (IARC) classified glyphosate as a probable human carcinogen in mid-2015, which has sparked world-wide concerns about why Monsanto failed to provide warnings and recommend safety precautions for users of Roundup.

Given the similar questions of fact and law presented in lawsuits filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated pretrial proceedings for all federal Roundup non-Hodgkins lymphoma cases in October 2016, centralizing the claims before U.S. District Judge Vince Chhabria in the Northern District of California to reduce duplicative discovery, prevent conflicting rulings and serve the convenience of the parties, witnesses and the courts.

While the manufacturer has maintained for years that Roundup is safe, documents obtained during the discovery process reveal that Monsanto may have secretly written portions of major studies that support the safety of glyphosate, then paid scientists to publish the findings without disclosing the company’s involvement.

More than 75 documents obtained during the discovery process have been released, with many showing ties between Monsanto and scientists, and even scientific journal editors, who appear to admit having influenced data and studies alleging that the active ingredient, glyphosate, was safe and did not cause cancer.

In one email, Donna Farmer, manager of Monsanto’s toxicology program, told other employees to walk a fine line regarding Monsanto safety claims, admitting that the formulations of Roundup had not been adequately tested to exclude the risk of cancer.

“The terms glyphosate and Roundup cannot be used interchangeably nor can you use ‘Roundup’ for all glyphosate-based herbicides any more. For example you cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement,” Farmer states in the email. “The testing on the formulations are not anywhere near the level of the active ingredient. We can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer.”

Many of the emails appear to bear out some concerns that while Monsanto tested glyphosate as an active ingredient, it never adequately tested how glyphosate worked with the other ingredients in the various Roundup formulations.

“We do not conduct sub-chronic, chronic or terotogenicity studies with our formulations,” one of the emails states. “The long term exposure has been assessed according to the regulatory requirements in chronic and carcinogenicity studies conducted with the active ingredient glyphosate.”

According to a report by the New York Times, the documents were released on August 1, following a 30-day period in which Monsanto could have objected, but did not. The documents are also being handed over to European investigators looking into claims that Monsanto manipulated scientific data and had undue influence among regulators in the U.S. and Europe.

Last month, a group of European Parliament members sent a letter to the U.S. judge presiding over the Roundup litigation, asking to be provided copies of the so-called “Monsanto Papers,” which link the company to the “ghostwriting” of studies about the safety of Roundup and it’s active ingredient, glyphosate. They are also asking for documents suggesting that Jess Rowlands, of the U.S. Environmental Protection Agency (EPA), worked with the company to hide evidence of links between glyphosate and cancer.

The EU members’ letter came in response to information disclosed during the discovery process in the Roundup litigation, including documents that suggested a former EPA official, Jess Rowland, reassured Monsanto that there would be no pesticide review for glyphosate.

Rowland reportedly even wrote that he “should get a medal” for protecting the company’s product. The documents also indicated that Monsanto had ghostwritten academic research articles indicating Roundup was safe and then paid other researchers to put their name on the bogus studies.

The letter from members of the European Parliament also outline concerns about the independence of their own regulators, indicating that Monsanto and the pesticide industry had advance access to a safety assessment of glyphosate conducted by the European Food Safety Authority (EFSA) in 2015, and even were able to edit the documents at the last minute.

The emails also include communications from scientists and journal editors who consulted with Monsanto and appear to have hidden their links to the company. Others show those editors and scientists essentially admitting to manipulating data, ghostwriting studies and even influencing which studies get published on behalf of Monsanto.

Roundup Litigation

As part of the coordinated pretrial proceedings in the MDL, Judge Chhabria has previously determined that the Roundup litigation will be bifurcated, first addressing general causation about the link between the widely used weedkiller and non-Hodgkins lymphoma, before addressing case-specific issues about whether Roundup caused cancer for each individual plaintiff.

With Roundup cancer lawyers continuing to review and file new claims for farmers, gardeners, landscapers and other agricultural workers diagnosed with non-Hodgkins lymphoma, it is ultimately expected that hundreds, if not thousands, of lawsuits will be added to the MDL over the coming months and years.

Following resolution of any motions to dismiss based on general causation, if a Roundup settlement or other resolution for the litigation is not reached during the first phase of discovery, it is expected that Judge Chhabria will establish a bellwether process, where a small group of cases will be prepared for early trial dates to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the lawsuits.