When it comes to Roundup and cancer, everybody's lobbying the regulators

By Daniel Fisher | Mar 28, 2019

The federal jury that this week ordered Monsanto to pay $80 million for allegedly causing a man’s cancer likely was swayed by internal documents suggesting the unit of Bayer AG had improperly influenced regulators to keep its Roundup weedkiller from being classified a carcinogen.

The “Monsanto papers” repeatedly cited by plaintiff lawyers include a 2015 email exchange in which a company executive says an official at the Environmental Protection Agency boasted he “should get a medal” for killing an EPA review of data about possible cancer links that Monsanto opposed.

Monsanto wasn’t the only party lobbying regulators in 2015 to change how Roundup was classified, however. At the same time the Monsanto executive was talking to the EPA, Chris Portier, a former U.S. health official who’d signed on as a $450-an-hour consultant to plaintiff lawyers, was imploring European Union regulators to reclassify Roundup’s active ingredient glyphosate as a carcinogen. 

Days before Portier signed a contract with two leading Roundup law firms, the World Health Organization’s International Agency for Research on Cancer broke ranks with every other national regulatory agency in the world and said glyphosate could cause cancer. 

Portier was the chairman of the IARC committee that recommended the change, although he says he didn’t begin contract negotiations with the law firms until after his work at IARC was done.

Plaintiff-lawyer lobbying over glyphosate continues. An unusual news release by Health Canada in January reveals how much pressure one plaintiff lawyer, Brent Wisner, has brought against the Canadian agency responsible for evaluating the safety of drugs and pesticides. In it, Health Canada said it had rejected objections to its refusal to reclassify glyphosate that were filed by eight groups allied with Wisner’s law firm.

“Our scientists left no stone unturned in conducting this review,” Health Canada said. “No pesticide regulatory authority in the world currently considers glyphosate to be a cancer risk to humans at the levels at which humans are currently exposed.”

Undeterred, Wisner held a news conference in Toronto a couple of weeks later and appeared on Canadian television, accusing that country’s regulators of turning a blind eye to the alleged dangers of Roundup and likening it to tobacco and asbestos.

“If tomorrow they decided ‘you know what, it actually does cause cancer,’ they’d have to tell the world that for 40 years they’ve been wrong, that people have been dying under their watch,” he said in one interview. “It’s a lot easier to keep the status quo.”

The story plaintiff lawyers tell of Monsanto’s improper influence over the regulatory process appears to resonate with jurors. In the most recent case, the jury in California awarded $75 million in punitive damages to Edwin Hardeman, a man who blamed his non-Hodgkin’s lymphoma on regular use of Roundup to control weeds at his California properties. 

His lawyers urged jurors to award punitive damages to send a “loud message” to the company that its behavior was unacceptable.

Monsanto obviously scored fewer points by showing jurors how both sides have sought to influence regulators. In testimony and previous depositions, for example, Portier has acknowledged he was a senior scientist at the Environmental Defense Fund, which litigates against agricultural chemical companies, at the same time as he was chairman of the IARC Science Advisory Board that ultimately recommended classifying glyphosate as carcinogenic. 

IARC’s reclassification gave a huge assist to plaintiff lawyers with thousands of clients claiming Roundup gave them cancer, but was based upon “mechanistic” animal studies that other national agencies have rejected as inconclusive.

After signing a consulting contract with Lundy, Lundy Soieau & South and Weitz & Luxenberg, both leading Roundup plaintiff law firms, Portier aggressively lobbied EU regulators to follow the IARC’s lead and reclassify the weedkiller as a carcinogen. He didn’t disclose his ties to plaintiff lawyers in communications with the regulators, and told a journalist in 2016, when he’d been a paid consultant for more than a year, that “nobody has paid me a cent to do what I am doing with glyphosate” and “I have no conflict of interest whatsoever.”

Portier said he did less than 30 hours of work for the law firms in 2015 and 2016, when he was lobbying regulators to reclassify Roundup. Any letters to them were “done on my own time, using my own resources, and written by myself or in collaboration with my co-authors.” As an “invited expert” on the IARC science panel, he said, he could not vote on the group’s conclusions and thus “cannot have affected the outcome of the IARC review.”

Bayer has repeatedly attacked Portier’s credibility in court and said it is fighting other efforts by plaintiff lawyers to change how Roundup is regulated. Those efforts have largely failed, although environmental groups, some of them allied with U.S. lawyers, obtained more than 1 million signatures for a citizens’ initiative to ban glyphosate in Europe. 

In December 2017, the European Commission approved glyphosate for another five years. France, Hungary, the Netherlands and Sweden are in an assessment group that will evaluate the science and present a recommendation in 2020.

“It is not uncommon for plaintiffs’ lawyers and their surrogates to lobby regulators in an effort to further their litigation interests, but the extent of their worldwide lobbying in connection with this litigation is unusual, and the consistent favorable conclusions of regulators speaks to the strong science supporting these herbicides,” the company said in a prepared statement after the California verdict.

Wisner, the lawyer who has repeatedly criticized Canadian regulators, didn’t immediately respond to a request for comment.

Roundup isn’t the only example of a product where plaintiff lawyers have attempted to influence the regulatory process in a way that would help their cases. Plaintiff lawyers have filed citizen petitions with the Food and Drug Administration, for example, to try to get additional warning labels approved for drugs they are suing over. 

If a company is required to add a warning label, lawsuits over injuries dating from before the change become much more powerful in court. In a Massachusetts case, Reckett v. Johnson & Johnson, a plaintiff witness, Randall Tackett, was part of a group that submitted a citizen petition urging the FDA to change the label for ibuprofen to include a warning about rare allergic reactions. He was later hired to represent a plaintiff in unsuccessful ibuprofen litigation against J&J.

(Both sides play this game as well: An academic study of citizen petitions found that more than half of the petitions between 2001 and 2013 were filed by pharmaceutical companies trying to block generic competitors from entering the market).

Bayer says it is neither uncommon nor inappropriate for companies to communicate with the agencies that regulate their products. 

“Like other companies and organizations in the United States and globally, we undertake efforts to participate constructively in the policymaking and regulatory processes and provide our input on legislation and regulations,” the company said. “Our relationships with all those in the public sector are routine, professional and consistent with all laws and regulations.”

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Bayer Corp. Monsanto Company

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