Narrowly defined decision provides guidance on ‘evidence’ for alleged cause of harm
Paul Driessen
Although the US Supreme Court frequently overrules it, the Ninth Circuit Court of Appeals (covering California, eight other western states and two US territories) deserves applause for its recent Engilis v. Monsanto decision.
The court affirmed a district court’s exclusion of “expert testimony” claiming a plaintiff’s exposure to the glyphosate-based herbicide Roundup caused his blood cancer (chronic lymphocytic leukemia). The court upheld summary judgment in favor of product manufacturer Monsanto (now owned by Bayer).
It was an important victory amid numerous lawsuits against the company for allegedly knowing this chemical is carcinogenic but failing to warn consumers. In fact, by 2020, mass tort litigation firms had lined up over 22,000 “corporate victims,” and San Francisco area juries had awarded several plaintiffs $78 million to $1 billion per person in compensatory and punitive damages!
One firm’s website even claimed the requisite exposure to Roundup could involve simply “living near a farm where the potentially dangerous herbicide is used.” The victim could thereby be afflicted with lymphoma, non-Hodgkin lymphoma, Parkinson disease, multiple sclerosis, lung, brain or thyroid cancer, heart disease or six other diseases. This is the warzone Monsanto had been dragged into.
The awards were subsequently reduced to “mere” tens of millions. However, faced with seemingly endless litigation, clever lawyers, and sympathetic jurors with limited grasp of science or medicine, in 2020 Bayer-Monsanto paid nearly $11 billion to a half-dozen law firms to settle most of the lawsuits.
It’s hardly surprising Monsanto settled and took glyphosate out of its US home lawn and garden Roundup formulation. But firms and plaintiffs not part of the settlement are still suing.
Peter and Cathy Engilis were among them. Unfortunately for them, their lawyers relied on the testimony of a board-certified oncologist who reviewed various possible causes of Mr. Engilis’s cancer, ruled out obesity as a contributing factor, and concluded that glyphosate was the most likely cause.
His testimony was the only evidence plaintiffs presented. The district court excluded it as unreliable, since the expert had failed to employ a scientific analysis to rule out obesity as a cause.
The Ninth Circuit agreed, ruling that an expert’s conclusions or opinions are not enough. Under Federal Rule of Evidence 72, experts must provide scientifically sound reasons for ruling out alternative causes and do so by a preponderance of actual evidence. Conclusory assertions are insufficient, unless supported by facts, data or studies, not merely knowledge or experience.
The US Supreme Court underscored these points in Daubert v. Merrell Dow Pharmaceuticals. Plaintiffs must prove the scientific evidence presented is relevant and reliable, the Court said. It must have been tested and peer-reviewed against prevailing standards; be accepted in the applicable scientific community; and show more than just circumstantial links between an injury and alleged cause.
Experts must also show how they reached their conclusions and point to objective sources that demonstrate they followed scientific methods practiced by at least a recognized minority in their field.
This is basic common sense and something law students learn in Evidence 101. As I argued in a medical journal article, it is especially vital in glyphosate litigation – and other complex, emotionalized cases, including lawsuits alleging damages from climate and weather events supposedly caused by fossil fuel production, refining, or use in transportation or manufacturing.
The jackpot justice Roundup cases rely on so much speculative “evidence” that they should all be dismissed, based on Daubert, Engilis, common sense, and the endless list of carcinogens we encounter during our lifetimes.
Glyphosate was introduced in 1974, is licensed in 130 countries, and is used every year by millions of homeowners, gardeners and farmers to control weeds. Studies and reviews by the US Environmental Protection Agency, European Food Safety Authority, UN Food and Agriculture Organization, Health Canada and dozens of other experts have found it safe and non-carcinogenic.
The US Agricultural Health Study has followed some 52,000 licensed private pesticide applicators (mostly farmers) and more than 32,000 of their spouses for nearly three decades. More than 80% of these test subjects used glyphosate. The study has found no glyphosate-cancer link.
Only one agency, the France-based International Agency for Cancer Research, says otherwise. In 2015, IARC ruled that glyphosate is a “probable” human carcinogen – based primarily on two mice studies, which multiple investigators said manipulated data while ignoring studies that contradicted IARC’s preferred conclusion.
Instead of doing research, IARC classifies chemicals as definitely, probably or possibly carcinogenic based on reviews of other organizations’ research – and by applying “exposure” or “hazard” tests that many epidemiologists view as antiquated and of limited value. Those tests use laboratory animals to determine whether a chemical might cause cancer, even if only at extremely high levels that no animal or human would be exposed to in the real world.
Indeed, epidemiologists and toxicity experts say some chemicals may cause cancer or other serious health problems at extremely high doses but be harmless at levels encountered in our daily lives. Others may be harmful at high doses but beneficial or essential at low or very low doses.
IARC’s Group 1 carcinogens (“definitely carcinogenic”) include 120 chemicals, substances and industrial processes: plutonium, sunlight, aflatoxin, asbestos, cadmium, tobacco, welding, processed meats and more.
Group 2A (“probably carcinogenic”) lists 80+ chemicals, substances and processes, including glyphosate, dieldrin, malathion, acetaldehyde in bread, anabolic steroids, emissions from high-temperature food frying, red meat, drinking “very hot” beverages and working as a hairdresser.
Group 2B “possibly carcinogenic” materials and processes show “limited evidence” of carcinogenicity but includes diesel fuel, pickled vegetables, carpentry work, caffeic acid in coffee, nutritious foods like apples and broccoli, and over 300 other substances and occupations.
IARC carcinogen claims seem to be such outliers, so beneath scientific norms, so tainted by conflicts of interest and misconduct, so unrelated to actual risks, so deceptive and even fraudulent – that they should never be admitted as evidence in any glyphosate trial. But from a jackpot justice plaintiff or lawyer perspective, they are central to nearly every case.
Roundup carcinogen allegations should also be excluded from evidence and testimony because it is impossible to differentiate alleged effects of glyphosate from those of countless other chemicals, substances, occupations and industrial processes plaintiffs may have been exposed to or engaged in over the course of their lives. The lists presented above represent a tiny sample.
The same principles apply to climate lawsuits in state and international courts.
The lawsuits involve computer models with zero predictive capability; conclusory assertions devoid of actual supportive evidence; and refusal to recognize Earth’s tumultuous climate history, powerful natural forces that caused momentous climate changes long before the fossil fuel era, written records and data over the past 200 years showing no unprecedented changes or trends in climate or weather, and an inability to separate natural from alleged human causes.
Evidence Rule 72, the Daubert and Engilis decisions, and basic scientific principles demand summary judgments in favor of fossil fuel producers every single time.
Paul Driessen, JD is senior policy analyst for the Committee For A Constructive Tomorrow (www.CFACT.org) and author of books and articles on energy, climate change and pesticides.
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Round my way it’s anemophilous hell. The “lightly managed” Tooting Graveney common is around 250 metres from my garden and glyphosate is essential to keeping the invasions under control. I once tried the eco Roundup – no glyphosate – and it was nigh on useless.
There is no shortage of safety and handling instructions on the ‘plastic’ bottle and I have to wonder how people might have been using the product. Did they wash it off if they got a splash on themselves?
computer models
The last resort of the scientific scoundrel
computer models
The
lastfirst resort of the scientific scoundrelFollowed closely by “Attribution Statistics” which isn’t even science.
“it was nigh on useless”
There’s a new thing out called “Spruce” that’s supposed to be a miracle “all-natural” weed killer that’s better than glyphosate.
I got some and did an experiement. Two raised bed planters, same size, both overgrown with weeds. Applied the Spruce exactly according to instructions. Applied the glyphosate the usual way – which amounted to less than half of the new stuff.
Spruce claims results in an hour. An hour later, nothing had changed. A day later, glyphosate bed was starting to die off, no change to Spruce bed. A week later, glyphosate bed was all dead, Spruce bed was still green.
you’re eco-roundup was at least “nigh-on”, better than this stuff 🙂
There ya go.
Absolutely everything ever made was made from all natural ingredients.
I’ve been using glyphosate for over 3 years primarily to control out-of-control water lilies in a 440 sq m pond. The results have been great – lilies vanished, no other plants in the pond affected, fish, frogs, bees, dragonflies and birds all as usual. Meanwhile, my neighbour claims I have killed all the bees on her plot and am, in fact, threatening the lives of her and her children and her children’s children who live some km away.
Tuesday fun tip
This morning Auntie took it upon herself to factcheck Donald Trump’s talk on Paracetamol (Tylenol).
It was quite entertaining, they couldn’t really fault anything he said and ad-hominem remarks about Trump and Kennedy were pretty much all there was to be gleaned. The conclusion was even funnier…
Not factually incorrect…. But highly controversial.
In Nick like fashion, provide a link or it didn’t happen.
Cutting….
“Annie Lennox, Paracetamol in pregnancy, Liquid BBLs, Phubbing”
https://www.bbc.co.uk/programmes/m002jspp
President Trump has said that pregnant women should avoid paracetamol because of the risks of autism and that US doctors will soon be advised not to prescribe Tylenol, as paracetamol is known in the US, to pregnant women. However he didn’t provide any scientific evidence for this…
Isn’t there a report somewhere that says autism is caused by cellphone wavelengths ?
Likely yes. But more and better science says no.
Autism-like reports go back a long time with a somewhat modern description in 1799. So says “Search Assist” of DuckDuckGo. The kerfuffle seems to be over a recent rapid increase. If it is to get sorted out in my lifetime – they’d better hurry.
Spurious Correlations
There are some researchers who credit the “recent rapid increase” to better screening, changes in the definition and schools that get budget increases when they have more “disabled” students enrolled.
credit the “recent rapid increase” to better screening
I can’t help but wonder about overdiagnosis. When I took my daughter for an evaluation, the psychiatrist was already writing a prescription before we even sat down! Didn’t even bother talking to us or examining her. (We walked out)
How often does that happen?
(I should be clear, in that case it was ADHD, but I think the same may apply to other conditions)
BBC fact-checkers not being up to the job doesn’t prove anything.
It proves they still hire activists…
In the last 20 years, acetaminophen use has fallen due to the introduction of over the counter ibuprofen and naproxen – both for adults and children. So autism should have decreased. The other factor is how much pain/ill health the mother experienced during pregnancy. The reasons for taking the drug may be what is causing increased autism, such as infections/fever, dental problems, chronic back pain, ect.
One factor which is usually overlooked in epidemiological studies is social class. Many effects disappear if social class is regressed and eats up the variance.
“ect.”
You should see a doctor about that.
Latin: et cetera, abbreviated etc. Meaning: and other things.
I don’t know how many times I see that in student papers.
The main cause of increased autism statistically…is the increase in gov’t and organization-funded programs parents can put their kids into if a doctor declares them to be autistic.
At one time it was called “boys being boys”, now it’s a medical condition with drugs being prescribed. Makes life easier on the teacher to be able to drug the little rascals into somnolence, rather than having to discipline them. Not the district allows teachers to discipline any more.
The surprising thing is the reports about “Trump said” do not include the critical element that it was after receiving a vaccine that the Tylenol causes damage – the details are in the relevant paper he was citing. Reading the source doc was very convincing – it is a large and serious difference in occurrence of autism. Child gets a Vax + fever reaction + Tylenol = brain damage as Tylenol penetrates the blood brain barrier and drops the glutathione (?) level allowing inflammation to cause brain damage. The fever goes down (sort of by force) but the damage continues.
The article makes clear it is only the combination that has this effect.
The complaining about Trump should not say, “Trump claims…” They should say “Trump reports that a study that says…”.
One of the links in the article is to the Genetic Literacy Project. That site also hosts an infographic on conclusions reached by regulatory bodies around the world regarding glyphosate, the most recent addition being the European Food Safety Authority in 2023, describing their assessment as:
“…the most comprehensive and transparent assessment of a pesticide that EFSA and the EU Member States have ever carried out, taking into account thousands of studies related to human and animal health and the environment, and involving dozens of scientists from EFSA and national authorities across Europe”. They concluded that “the assessment of the impact of glyphosate on the health of humans, animals and the environment did not identify critical areas of concern”.
I refuse to give up sunlight, red meat and coffee, not necessarily in that order.
The main difference between an IARC rating and and a typical regulatory assessment is that IARC performs a hazard assessment and regulatory bodies perform a risk assessment (i.e. based on likely exposure in real world conditions). Health Canada’s Pest Management Regulatory Agency completed their last re-evaluation of glyphosate in 2017. An FAQ associated with that review addresses this difference:
Q7. Why does Health Canada consider glyphosate as unlikely to be a cancer risk while the World Health Organization’s International Agency of Research on Cancer has deemed glyphosate as “possibly* carcinogenic to humans?”
Hazard classifications are not the same as health risk assessments. Hazard classifications established by the World Health Organization do not take into account the levels of human exposure, which determines the actual risk. Pesticides are registered for use in Canada only if the level of exposure to Canadians does not cause any harmful effects, including cancer.
To reach its decision, the PMRA applies risk assessment methods that consider sensitive population subgroups in both humans (for example, children) and organisms in the environment (for example, those most sensitive to environmental contaminants).
As part of the re-evaluation decision for glyphosate, Health Canada reviewed the dietary exposure to glyphosate and found that the levels found in food would not be a health risk to Canadians.
* typo in original, should be “probably”
Apologies for partial duplicate below, this sat in moderation for a while, which is fair enough, but I mistakenly thought it was declined.
I wonder when “they” will rule sex is carcinogenic.
It’s true sex leads to a growth inside a woman and that has attributes similar to cancer growth.
/s
HPV? (Human papillomavirus)
ambulatory tumors…
Civil Court has a much lower burden of proof, which I believe the initial case was heard in.
My problem with the “probable” category is it includes working the late shift.
I’m not saying I have data to prove otherwise, rather, it just seems like a rather wide catch all.
The lower the bar…
I’ve always felt that civil suits should only cover compensatory damages. Punishment is the realm of the criminal courts with it’s higher burden of proof.
The idea that a company could be 1% responsible but be responsible for 100% of the compensation never struck me as legitimate. Lawyers would sue everyone and their brother, regardless of how tenuous the connection, just to make sure that one of the defendants had deep pockets.
I seem to remember reading a Reuters article a few years back that detailed an investigative report about how a trial lawyer paid an IARC “Scientist” $115,000 to produce a fraudulent summary of the research on glyphosate, reversing conclusions of the actual journal articles authors from non-carcinogenic to carcinogenic. Great investment for the trial lawyers – $115,000 for billions in fraudulent verdicts from which they skim off a significant portion.
I wasn’t aware Roundup had removed glyphosate. It’s still easily available in other brands so didn’t really change anything.
Great article, thanks Paul.
For readers information: In addition to the irregularities noted in the article, part of the reason IARC may arrive at a different conclusion than regulatory bodies is a fundamental difference in the nature of their assessments. An FAQ that accompanied Health Canada’s 2017 re-evaluation of glyphosate addresses this difference:
Q7. Why does Health Canada consider glyphosate as unlikely to be a cancer risk while the World Health Organization’s International Agency of Research on Cancer has deemed glyphosate as “possibly carcinogenic to humans?”
Hazard classifications are not the same as health risk assessments. Hazard classifications established by the World Health Organization do not take into account the levels of human exposure, which determines the actual risk. Pesticides are registered for use in Canada only if the level of exposure to Canadians does not cause any harmful effects, including cancer.
To reach its decision, the PMRA applies risk assessment methods that consider sensitive population subgroups in both humans (for example, children) and organisms in the environment (for example, those most sensitive to environmental contaminants).
As part of the re-evaluation decision for glyphosate, Health Canada reviewed the dietary exposure to glyphosate and found that the levels found in food would not be a health risk to Canadians.
This difference is much more than a nuance but often gets glossed over, if it’s even acknowledged.
For those interested in a deep dive on many issues related to the article above I highly recommend David Zaruk’s “Risk Monger” blog (linked in article text above under “manipulated data”), as well as “The FireBreak”, a substack by the same author.
Veritasium did a video on this not so long ago – https://youtu.be/CxVXvFOPIyQ?feature=shared
My takeaway is, don’t work in the factory where they make this stuff and you’ll probably be fine. Also, my plants, my seeds, and fork you if you think you own what grows on my land.
Roundup was introduced in 1974. My first use was in 1976. I’ve never been a large user, just a gallon (maybe 2) of concentrate per year. I’ll soon reach the 50 year mark of usage. I don’t believe it has affected me in any way. Others challenge that.
I have the feeling behind the scenes one could discover the zero linear threshold being applied.
Finally. Reality strikes again. It’s a good year.
Great article & good on the Ninth Circuit Court of Appeals. Missing from the list of probable carcinogens is shift work.
Quite likely, that with the Gen Z love affair with WFH, going to work and working in the premises of the employer will be added as probable or, maybe even as possible carcinogens, next time the IARC updates its Monograph 95.
The world needs more lawyers to help determine the nuances in the terms ‘probable’ and ‘possible.’
Cases like this are out of control. There are likely a few people who may have suffered ill effects from this product and all the rest of these freeloaders are giving them a bad name. The court system needs a serious adjustment.
It is well established that many of the class action lawsuits have coat tailors jumping on for a free ride. It is notable that the cost of screening out the free loaders exceeds the cost of buying them off.
I remember the VIOXX trial where the jury found that this NSAID had caused a heart attack. When a Journalist asked the jury foremen what they made of all that science stuff he answered oh we didn’t understand any of that science stuff.