Day 11 – The “Incredible Feces Error”
My hopes that Judge Bolanos was starting to see how extensively she has tied Plaintiff’s hands with rulings benefitting Monsanto came crashing down. Yesterday, on the jury’s day off, Plaintiff, Defendant and Bolanos met to continue debating the permissiblity of discussing NSRL, Prop 65, and several other issues. In every issue raised, Bolanos favored Monsanto. How could this be happening in a San Francisco courtroom?
It is not a case of better attorneys and arguments from the Defendent. Monsanto is strong, but so is the Plaintiff team.
It’s like the war chest of Plaintiff evidence has been lit on fire, and Monsanto is roasting freaking marshmallows. But fret not. The Plaintiff case is still strong, and today’s testimony by Dr. Sawyer made Monsanto look rather foolish.
Before the jury enters, both parties argue about discussing POEA, a highly carcinogenic surfactant that Monsanto uses in its US Roundup formulations.(1) Plaintiff would like to inform the jury, through Dr. Sawyer’s testimony, that POEA is banned in Europe due to proven high carcinogenic potential.
Bolanos rules that Plaintiff is not to mention the POEA bans in Europe because it is “unduly confusing and unduly time consuming.” What a weak basis for ruling. I presume that Monsanto seeks to hide from the jury any information about European agencies, except for information that benefits their side. All of these rulings on relatively petty matters add up over time, and the cumulative evidence excluded is definitely detracting from Plaintiff’s overall argument and ability to overcome the burden of proof.
GG SIDEBAR: How is it that the US gets all the crap versions of products? The downgraded products also appear in US cosmetics with plastic ingredients and foods with artificial dyes. Manufacturers know that the US is not as regulatorily strict on the health impacts of chemicals, so they make the higher quality product version for Europe and the junk product version for the US. European countries should market this fact for tourism.
THE TESTIMONY OF DR. WILLIAM SAWYER
After an outstanding day of questioning, I will trade the name Delightful Dickens for Dynamic Dickens, though he is still delightful. He is the total 180 of Lombardi. His manner warm, Dickens emits an energy of trustworthiness and dependability. If you saw him at a backyard BBQ, he’s someone you’d like to go chill with. His sweet disposition could not be more different from that of Lombardi, who is doing the cross today.
Lombardi conveys a smug aura of experience, and many more gray hairs. A quick search reveals that he has had numerous trial wins on patent cases for pharmaceutical companies. His clients on the product liability side include Philip Morris.
Big Pharma, Tobacco and Agribusiness – I see a theme in what cases he likes best.
Dr Sawyer is a toxicologist with a PhD from the Indiana University School of Medicine. Sawyer has more than thirty years of experience in public health and forensic toxicology. Through his consulting firm, Sawyer specializes in criminal and civil causation analyses for both plaintiffs and defendants. He has been an assistant professor of toxicology and public health at the SUNY Upstate Medical University for 22 years. Sawyer has published 8-10 original research papers and 25 review articles, including an extensive causation report surrounding 9/11 and related cancers.
The Court names Dr. Sawyer an Expert in Toxicology, Forensic Toxicology, and Related Assessments.
Dr. Sawyer is a mild mannered, fair haired guy who delivers information concisely and confidently. There is no hesitation during his testimony, except during the cross when he clearly tries to surmise what “gotcha” tactics Lombardi is attempting to employ. Amusingly, the guy goes missing a few times after breaks, perhaps a bit absent-minded-professor-esque. Both after lunch and after an afternoon break, everyone awkwardly waits for Sawyer to re-enter the courtroom. Wisner, in all seriousness, states, “I’m sorry your honor, Dr. Sawyer is missing again. He seems to wander off…” Attorney Michael Baum, of Baum Hedlund fame, ducked out to fetch him.
Sawyer leads with his conclusion: “Glyphosate, based on animal test data, is carcinogenic by itself. There are additives in Roundup that increase and enhance carcinogenicity through several mechanisms.”
During a telephone interview with Johnson, Sawyer collected extensive data on the specific details of Johnson’s use of Roundup and Ranger Pro. Johnson was heavily exposed, far more than the individuals in internal Monsanto exposure studies. In using Ranger Pro, Johnson would get a wet face and become notably damp or wet with the chemicals. His use of the product was 50 gallons/hour, which is considered extremely heavy use. Backpack sprayers average 16 gallons/hour. Johnson would go through 150 gallons in one day using a large hydraulic hose connected to a 50 gallon tank. This hose had uncontrollable pressure – it was either on or off. That type of spraying is like using a pressure washer hose. It creates significant aerosol fog all around the area that is sprayed. Sawyer notes that, “One trigger would fill the courtroom with mist.”
Nothing in the labeling warned against this mode of application. Sawyer is not aware of any warnings from Monsanto whatsoever.
The studies regarding exposure that Sawyer uses in his expert testimony are both sourced from inside Monsanto as well as published externally. The key studies that he relied upon were “actually Monsanto studies.” Sawyer explains that Toxicologists are like detectives, looking hard and deep for all evidence regardless of whether positive or negative for the client. That is what he did in this case in investigating the exposure dose, which was thoroughly calculated in internal Monsanto operator exposure studies. Sawyer is looking to see if Johnson was significantly exposed, and if so, was the exposure dose substantial enough to cause damage to his stem cells and cause NHL?
So what is an Exposure Dose? Exposure is how much material gets ON the body. Dose is how much gets INTO the body. Exposure dose is also known as a Systemic Dose.
Sawyer explains surfactants by drawing a parallel of a freshly waxed car and a drop of water. The water will just repel off of the wax surface unless a soapy surfactant is added to the water. The soap reduces the repelling action of the wax. The surfactants in Roundup and Ranger Pro help the chemical spread across the surface of a leaf and enhance the permeability of human skin.
SURFACTANTS AND SKIN ABSORPTION
In an exhibit that was remarkably not ruled out by Bolanos, Sawyer lists the ways in which surfactants can increase glyphosate absorption through the skin:
- Removal of lipids from the epidermal surface due to surfactant action. On the surface of our skin, we have a lipid structure that is designed to repel aqueous substances. POEA breaks down that protective lipid barrier, thus allowing more absorption of glyphosate into the body.
- Increase the hydration state of the skin, just like a skin cream would
- Increase of skin contact – when coupled with POEA, the glyphosate spreads over a wider area of skin, like the example of a water droplet + soap on a freshly waxed car
- Increase of contact time with the skin due to decreased evaporation of water from the droplets containing surfactant
- Increase of sub-epidermal blood flow due to irritant action of surfactant. When skin is irritated, it turns red. Once the skin becomes irritated, dermal absorption increases. If a person is chronically exposed, skin irritation would fuel greater absorption.
- Intra-epidermal and sub-epidermal intercellular water accumulation due to the irritant action of the surfactant.
In addition to increasing the penetration of glyphosate into the body, POEA has its own genotoxic profile. POEA binds to and corrupts DNA. Monsanto has never done a carcinogenicity study on POEAs. The EPA did a crude evaluation of it by computer that showed roughly no risk. Universities have done independent studies that show POEAs cause oxidative damage in human cells.
In regards to POEA, Sawyer explains that there are safer, less toxic options. Those safer surfactants were available to Monsanto in 2012. There are many non-ionic surfactants that are harmless and used in medicine. Dickens asks whether Monsanto had any other glyphosate formulations available that used surfactants other than POEA. Sawyer answers yes, and that is some parts of the world, they had to.
Very nice non-specific suggestion of the European ban.
SURFACTANT TOXICOLOGY AS PER MONSANTO
Sawyer then reports that Monsanto employee Dr. Mark Martens prepared an internal slide presentation on general conclusions on surfactant toxicology. Martens noted that:
- Surfactants are biologically not “inert,” they can be toxic and this must be addressed.
- Part of the toxicity of surfactants is related to the surfactant action which destabilizes cell membranes.
- Part of the toxicology of surfactants can be specific (i.e skin sensitization, estrogenicity).
- Toxicity of surfactants depends on their concentration in the formulation.
- The high added value of herbicide formulations containing surfactants resides in the optimal compromise between efficacy and safety for man and the environment.
ROUTES OF EXPOSURE
Sawyer explains that the routes of human exposure are mostly dermal. Johnson wore a dust mask over his nose and mouth, which should have provided protection from inhalation. Operator exposure studies have demonstrated that even without a dust mask, inhalation is a minimal portion of an overall systemic dose.
Hair follicles are a direct route for chemical absorption. Someone with more hair follicles will have enhanced dermal absorption. This is something for all hairy folks to remember!
In determining how much of the Roundup/Ranger Pro dose is absorbed systemically, Sawyer used specific studies performed by Monsanto and their contracted scientists. Dickens points out that we are not allowed to discuss the individual studies that he used in his analysis. That is just so infuriating and I hope that the jury has a sense of how ridiculous that is.
Sawyer continues that, based on Monsanto reports, 10% of the dose is absorbed systemically into the skin and body. 90% can be washed off. Sawyer begins to explain that in the Monsanto operator studies, sprayers wore patches on their bodies. After work for 6 hours, the patches are….then there was an objection, and we move on. That sounds like it would be a convincing study. Sawyer further confirmed his 10% absorption calculation using primate studies.
Oh, and Monsanto only submitted select internal exposure and absorption studies to the EPA – not every study that they conducted.
Dickens tells Sawyer: “In Dr. Farmer’s testimony, she said that none of the systemic doses estimated in the Farm Family Exposure study approached the US EPA Reference Dose (RfD) for glyphosate of 2mg/kg/day.”
OBJECTION – Lombardi shouts that: “We had a lengthy discussion about this yesterday!” Bolanos tells Dickens that he can proceed.
Dickens asks Sawyer what a “reference dose” is that is mentioned in the sentence. Sawyer briefly explains that the EPA RfD has nothing to do with carcinogenicity, only birth defects.
The testimony starts to change focus as to how one evaluates how much Roundup is absorbed by the body. Sawyer explains that when a study involves injecting animals with Roundup by IV, the liver is so overloaded by such a high quantity of Roundup that the body sends excess directly to urinary excretion. In chronic dermal absorption, the absorbtion is so slow that the liver metabolizes all of it, and the metabolites are excreted through feces. Sawyer concludes that any study that measures chronic dermal absorption levels by way of urinary excretion grossly underestimates the true absorption level.
I now know a great deal about the sweet Dupont Tyvek 400 protection suit that Johnson wore. It turns out that this is a dust suit that is not designed for liquids. It is more appropriate for applying talc to a baseball field. This suit does not allow aerosol penetration because droplets can’t fit through the material. However, if a person is directly covered with the chemical, as was the case in Johnson’s accidents, it can penetrate. While Monsanto labeling doesn’t recommend any kind of suit, their internal research concluded that full faceplates, waterproof jackets and coveralls should be used.
GG Sidebar: WHY WOULDN’T MONSANTO SHARE THIS INFORMATION?? I know the answer. That was just a moment of infuriation.
Sawyer argues that 2.25 years is definitely long enough for NHL to form from a Roundup exposure, particularly in an acute exposure of the likes of Johnson. He references a 1992 NHL study on latency by Dr. Dennis Weisenburger. In particular, this set of latency curves in which he considers Johnson’s case to fall under Curve A, the acute dose. (2)
CROSS-EXAMINATION OF DR. SAWYER
Wisner helps Lombardi move the podium to the center, exhibiting what a helpful Samaritan he can be.
Lombardi announces that today he is going to try to quiet his voice, as to be more appropriate for the small size of this courtroom. Thank goodness, his loud questioning was just so incredibly grating last time. During this cross, Lombardi does nearly all of the talking, not Sawyer, so at least he is using his inside voice.
Before going into detail on the cross, I will spoil the ending. Defendants definitely LOST the head to head with Plaintiffs in this cross-examination. Sawyer came alive. He was pleasant but firm and refused to be steamrolled by Lombardi.
Here is an abbreviated breakdown of the cross:
- Lombardi states that due to Sawyer’s previous work of providing testimony in lawsuits, he must be “very experienced, not nervous at all.” Sawyer just stared at him. It was incredibly awkward for Lombardi, and we got a good chuckle in the stands.
- Sawyer has advised other toxicologists on how to think about gathering studies for evidence in litigation. Lombardi tries to use this to paint Sawyer as a money-making, scheming kind of guy.
- Lombardi states that Sawyer: “Knows from (his) studies that the hands are particularly important to protect. The hands are what the studies show as the location (where absorption would happen).” Sawyer says that actually, the back of the neck is significantly more impacted than any other part of the body when using a backpack sprayer. Next would be the hands.
- Lombardi repeatedly asks Sawyer if he performed any calculation of Johnson’s actual Ranger Pro penetration. Sawyer repeatedly answers, “No, of course I didn’t spray him to see what would happen. I used the Monsanto study numbers.” Lombardi asks if Sawyer did any calculations of Johnson’s actual mask. Sawyer again responds, “Of course not. I can’t go back in time and measure that.”
Sawyer reasserts that looking at urine as an indicator of absorption is an enormous error. Lombardi argues that published research says to look at urine, and he only wants to discuss the published research studies. Sawyer emphasizes that most of the studies that he based his testimony on were by Monsanto or Monsanto sub-contractors.
There is a study that takes center stage – the Wester study on glyphosate binding and absorption. (3) Lombardi bullies Sawyer: “(The Wester study) was a dermal study that you’ve never done with monkeys. Were you aware that Wester published over 400 studies in his time? That is more than you published, right? In his study, he came to the conclusion that most of the glyphosate absorbed in the monkeys was absorbed and subsequently excreted through urine.”
Sawyer calmly replies: “No you are incorrect.” When received by IV, it mostly comes out through urine. Not true with dermal exposure, which is primarily excreted through the feces. This is important to note because any study that is testing dermal absorption that uses urine as a measure is inaccurate. Even if the IARC did cite the Wester study as-is with no critical discussion.
Lombardi continues his highly condescending cross examination. It is just SO rude – his tone of voice is uneccesarily hostile. I can’t imagine that it is sitting well with the jury – no one should be spoken to with such disrespect.
Trying to ridicule Sawyer regarding the urine vs feces argument, Lombardi mocks Sawyer: “IARC said nothing about this INCREDIBLE FECES ERROR that you describe!”
Lombardi decides to make a live handmade list of suggested latency periods for NHL on a piece of binder paper, displayed on the overhead projector. He goes through several studies regarding suggested NHL latency and lists them on the paper. He includes Portier (6/7 years), Weisenburger (15-20 years), Erikkson (10 years).
Sawyer is nearly in disbelief, and says that while all are latency estimates, they are related to chronic long-term environment exposure. He suggests to keep in mind that these are the mean or median values, not the extent of the range of possible latency. Furthermore, latency is tricky to estimate, so the range of 1-25 years is reasonable.
BAM, WHAT? That made Lombardi’s little drawing look ridiculous.
During the re-direct, Dickens asks about the Wester study. Sawyer says that there are published studies that discuss and elucidate the finer details of the Wester study, but that these are studies: “That I am not allowed to talk about.” (E.g., the studies Bolanos previously excluded from testimony).
This whole testimony looked awful for Lombardi. By making sure so many studies were excluded, it actually resulted in Lombardi looking confused.
Regarding the “Incredible Feces Error” – the studies show that Sawyer is correct that chronic dermal exposure will deliver a plethora of Roundup metabolites to your Feces.
Friends – what does this mean for our microbiome and intestinal permeability? HOLY COW IT IS ALL COMING TOGETHER. And this case doesn’t even address chronic oral exposure.
Immediately upon jury exit, Lombardi launches into a fit stating: “Dr. Sawyer made an absolute mockery. He threw in extraneous studies and was informed he shouldn’t…It is improper and something has to be done.”
Lombardi continues that Sawyer’s admissions that: “I’m not supposed to talk about it,” (meaning other research), is completely improper. He recommends a cautionary instruction to the jury not to consider the fact that the witness said such things.
Wisner replies that Lombardi repeatedly set Sawyer up to look unknowledgeable throughout his line of questioning. Lombardi wanted it to appear that Sawyer had no other research to rely upon in his expert testimony and that no other studies even existed. Sawyer saying he isn’t allowed to talk about other research…well that derailed Lombardi’s hope of painting Sawyer as baseless.
Wisner announces that Lombardi: “Can’t use (excluded research) as a weapon and a shield.” Also, that Lombardi is: “Upset that the cross was not as effective as he would like.” (Tee Hee)
Bolanos asks for counsel to meet and confer regarding a curative instruction.
More testimony – Plaintiff’s last witnesses!
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