EPA Science Could Torpedo Roundup Lawsuits

Paul Driessen Jan 13, 2020

The US Environmental Protection Agency (EPA) recently issued a finding that could – and certainly should – undermine some of the most outrageous lawsuits and jury awards in American history.

Bolstered by San Francisco area juries that have given multi-multi-million-dollar awards to clients who claim glyphosate (the active ingredient in Roundup weedkiller) caused their cancer, jackpot justice lawyers have recruited some 20,000 additional “corporate victims” who hope to reap their own fortunes.
Their cases are based on the assertion that:

(a) Bayer-Monsanto negligently or deliberately failed to warn consumers that the glyphosate it manufactures is carcinogenic;  

(b) the plaintiffs used Roundup at some point in their lives; and  

(c) their short or long-term use of the chemical caused their Non-Hodgkin Lymphoma or other cancer. Those claims are dependent on several essential factors.

First and foremost, a 2015 determination by the France-based International Agency for Cancer Research (IARC) that glyphosate is a Group 2A probable human carcinogen. Second, a 2017 decision by the State of California to add the chemical to its Safe Drinking Water and Toxic Enforcement Act (Prop 65) official list of carcinogens, based on the IARC decision. Third, the state’s requirement that all Roundup labels must therefore carry prominent warnings that the product “probably” causes cancer.

Monsanto and Bayer insist that their product is safe and non-carcinogenic; Roundup labels thus did not carry warnings. But that gave plaintiff lawyers the opportunity to argue in pleadings, courtroom statements and media ads that the company negligently or deliberately caused serious health risks.

In the minds of presiding judges and jurors, if it was “possible” that even short or occasional exposure to Roundup could have caused cancer – even if it was an extremely remote likelihood – the manufacturer was guilty, and liable. Hence, awards in the tens of millions or even billions of dollars were justified.

There are numerous fundamental, even monumental, problems with this strained reasoning – and they are likely to be exacerbated by the August 7, 2019 EPA decision and strongly worded guidance letter.

IARC is virtually the only organization in the world to conclude that glyphosate is carcinogenic – and it based its conclusions on examining just eight studies. Far worse, subsequent reviews by epidemiologist Dr. Geoffrey Kabat, National Cancer Institute statistician Dr. Robert Tarone, investigative journalist Kate Kelland and “RiskMonger” Dr. David Zaruk demonstrated that the IARC decision resulted from bias, improper revision of study data and/or results, and collusion between glyphosate trial lawyers and the IARC consultant who led the agency’s investigation and was paid handsomely by the trial lawyers.

Equally outrageous and illuminating, IARC classifies red meat, very hot beverages, emissions from frying food, even doing shift work as “probable” human carcinogens – in the same category as glyphosate. It lists pickled vegetables and caffeic acid in coffee, tea and broccoli as “possible” human carcinogens. It even admitted that its glyphosate decision was based on only “limited” evidence of cancer in humans and “sufficient” evidence of cancer in experimental animals. IARC seems to say everything causes cancer.

Perhaps that is because, to reach its conclusions, the agency relies on what toxicity experts call “exposure” or “hazard” tests. That antiquated approach uses lab animals to determine whether a chemical might cause cancer – even if only at ridiculously high levels that no animal or human would ever be exposed to in real life. It refuses to rely on the modern approach of assessing actual risk, by determining the exposure level at which a substance might actually have an adverse effect on animals or humans.

And yet the judges in these cases let the plaintiff lawyers focus on IARC’s claims of carcinogenicity, while they prevented defense attorneys from countering IARC cancer claims or discussing its gross misconduct. They even barred the presentation of extensive evidence that glyphosate is not carcinogenic.

In fact, glyphosate has been used safely since 1974. It is now licensed in 130 countries for more than 100 food crops. Over the past four decades, respected agencies and organizations worldwide have conducted over 3,300 studies, and every one of them concluded that glyphosate is safe and non-carcinogenic.

Reviewers include the European Food Safety Authority, European Chemicals Agency, UN Food and Agriculture Organization, Germany’s Institute for Risk Assessment, Australia’s Pesticides and Veterinary Medicines Authority, Japanese and New Zealand agencies, and the US Environmental Protection Agency. “No pesticide regulatory authority in the world considers glyphosate to be a cancer risk to humans at the levels at which humans are currently exposed,” Health Canada noted. Meanwhile, the National Cancer Institute’s ongoing Agricultural Health Study has evaluated 54,000 farmers and commercial pesticide applicators for over two decades – and likewise found no glyphosate-cancer link.

Amid all of this, the “cancer victim” patients and their lawyers benefitted immensely from endless print, radio, television, online and social media campaigns that have misinformed, pressured, harassed and intimidated prospective judges and jurors. Many of these campaigns and several “educational think tanks” are funded, directly or indirectly, by the predatory tort lawyers and their anti-chemical activist allies.

To top it off, the judges and tort lawyers have made it difficult or impossible for Bayer-Monsanto attorneys to present other highly relevant evidence: such as plaintiffs’ family cancer history and personal dietary and other lifestyle choices – and their exposure to scores of other definite, probable and possible carcinogens on IARC’s list of hundreds of human cancer risks, including those mentioned above.

The supposed corporate cancer victims were allowed to argue that, despite all these other factors, including multiple other carcinogen exposures, their cancer was due solely to their exposure to glyphosate.

Enter EPA. The agency had already conducted lengthy and extensive reviews of the global compendium of studies and regulatory decisions on glyphosate – and had likewise concluded that “glyphosate is not likely to be carcinogenic in humans.” But at least one judge blocked the introduction of the EPA analyses, claiming “the primary inquiry is what the scientific studies show, not what the EPA concluded they show.” He didn’t seem to mind that IARC doesn’t do original studies either – and its ruling on glyphosate was based on what IARC concluded eight studies showed, while ignoring 3,300 contradictory studies.

It will henceforth be much harder for tort lawyers and trial judges to pull that cute little tactic off again. As noted above, EPA has issued a guidance letter – based on (a) its careful “independent evaluation” and reexamination of scientific studies and regulatory determinations around the world; and (b) its regulatory and labeling authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

Not only does EPA “disagree with IARC’s assessment of glyphosate.” It concludes that the chemical “is not likely to be carcinogenic to humans.” Equally important, based on its findings, EPA now holds that any “Proposition 65 warning language” based on claims that glyphosate is carcinogenic “constitute[s] a false and misleading statement.” Any products bearing Prop 65 warning statements due to the presence of glyphosate in them are thus “misbranded.” EPA will no longer approve such labels, and any such warnings “must be removed from all product labels where the only basis for the warning is glyphosate.

Applying that decision to these lawsuits, because glyphosate is not carcinogenic, Bayer-Monsanto was and is under no obligation to put warning labels on Roundup containers, stating that the chemical causes or “probably” causes cancer in humans. In fact, the company is legally obligated not to issue such warnings, because they would make the label “false and misleading.”

There is therefore no basis for cancer claims based on IARC’s erroneous, sloppy, collusive, even fraudulent “science.” Thus there is no legal or scientific basis for these lawsuits and jury awards.

It’s time for trial and appellate court judges – and state and federal regulatory authorities – to implement these EPA findings in courtrooms, in news and activist website statements, and in the ubiquitous ads that are trolling for still more Roundup-glyphosate “victims” and predatory tort lawyer clients.

Paul Driessen is senior policy analyst for the Committee For A Constructive Tomorrow (CFACT) and author of books and articles on energy, climate change and economic development.