The Witch-Trials Return: Rematch On Roundup

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With the EPA finding that glyphosate is not likely to be carcinogenic to humans and the plaintiffs’ five-case winning streak against Bayer broken, things had been looking up on the Roundup event horizon. Alas, last week’s verdict dinged Roundup yet again. and some 40,000 cases are still pending. What can we expect next?

Most cases against Roundup are pending in state courts that do not adopt the Daubert (reliability) standard and Rule 702 of the Federal Rules of Evidence. These cases are decided under the older Frye standard, which simply requires a consensus in the scientific community to lay the groundwork for expert testimony establishing a causal connection between the product and the claimed harm. This is amply provided by the unfortunate and suspect IARC classification of glyphosate as a Category 2A (probable carcinogen), notwithstanding significant opinion to the contrary. [1]

Based on these parameters, the plaintiffs are finding it easier to establish the first part of the causation question, general causation, i.e., does the product cause harm in the general population? But that alone isn’t sufficient for plaintiffs to prevail.

The Specific Causation Conundrum

In addition to proving general causation, which may be getting more challenging given the EPA finding that “glyphosate is unlikely to be a human carcinogen,” the plaintiffs must prove specific causation, i.e., did the chemical cause cancer in this particular plaintiff? Given that almost everyone has been exposed to the stuff and few people have non-Hodgkins lymphoma (NHL), this should be tough.

Proving specific causation entails establishing adequate dose (i.e., the extent of exposure) and eliminating causal exposures from other risk factors, including idiopathic causes, that 70% of NHL cases for which we don’t know the cause. Among the causes we do know are the ubiquitous EB virus, Helicobacter pylori, responsible for the common stomach ulcer, and a host of other chemicals and viruses, including Pentachlorophenol, a chemical extensively used in insect-proofing wood-ties in the railroad expansion of the 1950s. Even the IARC  identifies these culprits as more probably related to NHL causation than glyphosate. 

The American Cancer Society’s list of risk factors is even more extensive than the IARC’s. They note that race, age, weight, a host of infections, chemotherapy, autoimmune status, and even breast implants can increase the risk of NHL.

The muddy scientific waters generated this summary from one judge:

“Plaintiffs’ specific causation expert …  acknowledged that, even as of the time of trial, whether glyphosate is a carcinogen was a question about which “reasonable people can disagree.”  In sum, there is evidence in the record on both sides of the issues, what I would describe as a genuine dispute.” 

Ruling out these risks as causal is expert-dependent; hence, assuring reliability on specific causation may be problematic. While this may not be an issue in state court where reliability isn’t required, it is a problem in Daubert jurisdictions. In both venues, though, the credibility of experts is crucial.

Hoisted by their Own Petard

One potent plaintiff claim is that studies asserting no chromosomal harm were “predominantly funded by Monsanto.” They regard this as impugning the scientific credibility and integrity of the study results. It’s interesting to contrast this with their view of the finances of one of their experts, who testified about studies showing harmful effects on DNA:

“During questioning, [plaintiff’s expert] DeGrandchamp admitted that he’s made most of his money in the past 30 years by being a paid expert in court cases, earning about $2 million lately.”

Interestingly, as the plaintiff’s lawyers state:

“While [DeGrandchap’s practice]… might raise some eyebrows, it’s a regrettably common practice for experts on both sides in mass torts in 2023. Let’s hope the jury focuses on the solid science he’s sharing.”

Yes, indeed, let’s hope the jury focuses on sold science when both sides testify.

The Crux of the Cases: Failure to Warn

The fact that plaintiffs have succeeded in procuring high punitive damages awards signals the juries’ disdain for Monsanto for something other than manufacturing a defective product. Indeed, last week's verdict against Bayer (which bought Monsanto) included a two billion dollar punitive award. So, how could this happen?

One tactic has been claims that Monsanto frustrated efforts to test their product and disavowed knowledge of any harm.  Monsanto/Bayer may not have acquitted themselves well on this issue last go around, and substituting new experts for older ones and a new strategy didn’t seem to win them points, either.

In the last trial, the defense tried to reconfigure a Monsanto toxicologist named David Saltmiras (who would testify about the knowledge Monsanto had at the time and the decisions to test) into an expert witness, attempting to transform his opinion evidence into expert testimony. This tactic was not received well by the court – a sentiment that was apparently seized on by the jury.

While the plaintiffs' bar hopes Bayer will slap a warning on its products and settle the remaining cases, Bayer is contesting the verdict, which they claim was reached in a court described as a Judicial Hell-Hole, Philadelphia’s Court of Common Pleas.

“We disagree with the jury’s adverse verdict that conflicts with the overwhelming weight of scientific evidence and worldwide regulatory and scientific assessments, and believe that we have strong arguments on appeal to get this verdict overturned.”

Is that all there is to it? A Deeper Dive

Because the epidemiology is so fraught regarding causation, and the evidence against Monsanto’s ethics is massive (although not legally compelling), it shouldn’t be surprising that juries are looking for another hook, other than a defective product, to hang Bayer. And they found it. Even in the blockbuster cases, juries rejected finding that Roundup was defective or that Monsanto was negligent while still saddling the defendants with massive verdicts.

The latest trend bypasses the causal epidemiological battles. Instead, the focus is on failure to warn that the product could cause cancer. This is not dependent on scientific proof of direct causality but rather on existing knowledge and on potential causality, the latter being a far lower bar:

“A duty to warn arises when a “potential risk,” here the risk of cancer, is “known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution.  …. A ‘potential risk’ is one ‘existing in possibility’ or ‘capable of development into actuality.’”

While the pressure on Bayer to affix warnings to the product is intense, the Ninth Circuit ruled that requiring a warning under California’s Proposition 65 is unconstitutional based on the EPA’s latest evaluation. Bayer, which is opposed to warnings, relying on the EPA’s finding, contends it is unnecessary, claims the issue of warning is a legal question triggering the preemption doctrine (where Federal law takes precedence over State law [2]), and is begging for a Supreme Court review.

The failure to warn theory will likely Impale itself on other legal concerns. Thus, a  new meta-analysis [3] reports an attributable increased NHL risk of 41% to glyphosate; Courts are going to have to analyze whether

  • The meta-analysis is reliable and
  • The 41% attribution reaches the required civil threshold of proof.

Qualitatively, the fulcrum for imposing liability tilts at a “more probably than not” level, requiring one jot over 50% confidence that the credible evidence supports the claim for the plaintiff to prevail.  Strictly speaking, even if glyphosate increases NHL risk, the increase should be considered less than legally necessary to impose liability, providing ample grounds to reject this claim.

Roundup cases have become a thorny legal thicket involving “ugly” practices claimed against a “greedy” company, even if not causal, coupled with a sympathetic and ill plaintiff and a theory that only requires a potential for disease. Revising rules of scientific admissibility is not the solution. The law must first sort itself out on the warning and risk requirements. Training judges in epidemiologic principles and practices and sensitizing them to idiosyncratic epidemiological slights-of-hand and unreliable interpretations of fuzzy data might help – and can’t hurt.

The Science of Surfactants– The New Round for Roundup

With the science legally equivocal on the glyphosate-NHL connection, the plaintiffs’ bar has in its “back of tricks” a focus on the argument that it’s not glyphosate alone that causes NHL, but glyphosate in combination with other Roundup ingredients, notably Roundup’s surfactants, that exacerbates glyphosate’s allegedly carcinogenic effects.

Surfactants are everywhere. They are compounds with “a hydrophobic (water-hating) tail and a hydrophilic (water-loving) head.” The combination of these two properties allows water-hating chemicals to stay mixed in water – like your salad dressing that contains both oil and water or mayonnaise or cosmetic “emulsions.” Your skin’s outer layer also contains surfactants to keep you from losing moisture. Detergents are predominantly surfactants, allowing the soap to remove dirt more efficiently. Surfactants also reduce “water tension,” allowing fluids to flow across surfaces more easily; they function in our lungs to help keep our small air sacs open, and the surfactants in our joints help to keep them lubricating and moving smoothly.

Roundup’s main ingredient is water. The added surfactant allows the product to preferentially stick to the weeds instead of falling onto the soil (saving product and reducing its cost to use). Monsanto’s regulatory toxicologist, Donna Farmer, does an excellent job defusing the hysteria and explaining surfactant use and purpose in Roundup here.

“Roundup is considered to be more carcinogenic than Glyphosate alone.”

– Atraxia [Plaintiffs] Law [Firm].

There doesn’t seem to be much epidemiological evidence for or against the carcinogenicity of glyphosate and surfactant, as opposed to glyphosate alone. While surfactants initially used in glyphosate-based herbicides were considered toxic, they have been replaced since the 1990s.

As a class, surfactants are considered inert by regulatory authorities, so much attention isn’t paid to them, nor are detailed studies regarding their toxicity required. This means it may be difficult for the plaintiffs to prove their scientific case and for Bayer to rebut it (although the legal burden of proof is on the plaintiff). That Monsanto could have done these studies and chose not to (even though there was no legal requirement to do so) isn’t going to win them many fans.

Going Forward

It remains to be seen how Bayer’s lawyers will counteract this theory going forward and how successful they will be. Likely we can expect a new cast of experts. It isn’t clear though, if Bayer is primarily concentrating on assuaging the risks of Roundup [4] or mitigating the risks of  Roundup litigation. Here’s Bayer on the situation:

“Bayer continues to make progress on its five-point plan to manage and mitigate the risks of Roundup™ litigation in the U.S. We settled most of the claims in this litigation and have appropriately provisioned for the remaining claims. Having won trials, the company will continue to try cases based on decades of science and worldwide regulatory assessments that continue to support Roundup’s safety and non-carcinogenicity.”

 

[1] The International Agency for Research on Cancer’s (IARC) 2015 reclassification … belies the continued debate around the status of this compound. Critiquing groups maintain that the overall weight of evidence still shows no significant risks …. Another subdivision of the World Health Organization, the Joint Food and Agriculture Organization, maintained in 2016 that glyphosate was unlikely to pose a carcinogenic risk. Many regulatory agencies, including the European Food Safety Authority and European Chemicals Agency, continue to hold the official viewpoint that glyphosate does not pose a genotoxic or carcinogenic risk to humans.

[2] The preemption doctrine honors federal agency regulations when state laws conflict. The impasse arises when common law claims, including failure to warn, are raised. Bayer is seeking a Supreme Court Review on the issue, which they claim will end the litigation:

“We have progressed in seeking an appellate review of our arguments on federal preemption with two cases awaiting decisions. The first is Carson, pending in the Eleventh Circuit Federal Court of Appeals. The second appeal is Schaffner, pending in the Third Circuit Federal Court of Appeals.”

[3] An overview of the study can be found in this blog post.

[4] Although they do have a webpage devoted to assuring Roundup Safety.