And so it begins. Day one of the first (and multi-year anticipated) federal trial – Hardeman v Monsanto.
As a journalism newbie, it didn’t occur to me until last night that I should probably get up to San Francisco early to guarantee a seat. You may remember that when I showed up to the Johnson trial, I knew very little except that I was so deeply perturbed by Monsanto that I wanted to go catch a glimpse of the haps. There was fanfare on Opening Statements day as local news agencies filmed in the halls and a reasonably sized crowd comprised the audience. Today, I’m concerned that all of the glorious, captivating press from the last six months about Roundup, Monsanto/Bayer, Cheerios, France, and NHL may lead to more competition for seats.
So, a 5am wake-up, 45 minute commute and 6:40 arrival at the courthouse it is. Indeed, there is considerably more hullabaloo for Trial #2. A line outside of Judge Chhabria’s 17th Floor courtroom has formed and some journalists have been camping out since 6am. I see many familiar faces. Journalists from Bloomberg, the Guardian, and WSJ populate the line. My husband informed me that journalists don’t like bloggers – I guess that’s a thing? Well, fortunately not in this crowd because this crew is really friendly. I am no threat. Under no circumstance could I write an unbiased, highly polished article on Roundup, Monsanto, Chhabria, and the much-touted “three pillars of science” all under the gun of a horrifically imminent deadline.
An enormous, airport-luggage-inspired cart filled with file boxes sits awkwardly towards the front of the line, glaringly unaccompanied. We wait some more.
Finally, at 8:00am, the door opens and a very stern security guy instructs us to dump food and drinks. Thank goodness I learned to keep my not-water drink in a water bottle. We are further instructed to turn off sound on electronics and prepare to go to an overflow room to watch the proceedings if there is no seating in the courtroom. I manage to score a seat. I heard from some Moms Across America friends that the overflow room showed a screen only of Chhabria’s face.
I make a quick stop in the bathroom. I’m not sure why courtroom bathrooms are obligated to use the most unflattering fluorescent lights. The lights predictably make me look dry, shiny, red, pale, old, not young, and sickly all at the same time. Well, fortunately it truly doesn’t matter because I don’t have to present anything to anyone. Chhabria, on the other hand, has his face enlarged and zoomed in on a big screen.
Let me introduce you to the lead attorneys in this trial.
Jennifer Moore has a long list of high-profile nationwide litigations, including the Johnson & Johnson Talcum Powder and Xarelto Products Liability Litigations. She studied law at the University of Kentucky Law School, and won several awards including Kentucky’s Outstanding Young Lawyer. She’s also published and spoken a great deal on Mass Tort Litigation in Healthcare
Aimee Wagstaff works on mass torts primarily in the pharmaceutical and medical device industries. She has significant experience navigating MDLs and JCCPs, and works to fight those companies who put profits before safety. Aimee received her law degree from University of Denver Sturm College of Law. She was included in the 24th Edition of The Best Lawyers in America for Mass Tort Litigation/Class Actions – Plaintiffs.
The Monsanto attorneys are young, hip, ethnically diverse and extremely sharp. During the early days of the MDL, I remember some much older, crotchety, and considerably less charismatic attorneys representing Monsanto. Post Johnson verdict, Bayer claimed that they would “vigorously defend glyphosate” in the legal battle, and the resumes of these three attorneys are, well, really couldn’t be more impressive.
Of the three Monsanto attorneys, Kilaru concerns me the most. His manner is calm, friendly, dare I say “delightful.” But he’s no softie in legal hardball. HIs academic achievements include Columbia University (Phi Beta Kappa) and Stanford Law School. His list of accolades is long, including Best Oral Advocate at the National Trial Competition.
Johnson was a federal prosecutor, litigating white-collar criminal matters. She received several awards in this position. Her clerkship in 2000 was under the Honorable Sandra Day O’Connor in the US Supreme Court. (I know, right?) At Yale Law School, she won a prize for the Best Oral Performance and Best Team Performance.
Stekloff, who will be delivering opening statements, went to UNC undergrad. (His support of Monsanto and his alumnus status from UNC makes me more convinced that UNC may have committed foul play last week in the UNC Duke Nike shoe tear controversy.) Like Brent Wisner, he went to Georgetown Law.
The jury enters and we all rise. I note that my leg muscles aren’t in great condition because I’m having to grab the seat in front of me to get to standing. Geez, must commit more to pilates, or to movement in general.
The jury is about what I would expect as a cross section of the enormous geographical area represented in our Federal District. For those who aren’t NorCal local, driving from East Palo Alto to San Francisco can be 2 hours ONE WAY. Driving from Sonoma, which is near Napa in the North Bay, can also be 2 hours. Between San Francisco and East Palo Alto, or San Francisco and Sonoma, there are microcommunites of all kinds. In fact, this jury looks similar to the randomized mix I see on my average trip to the DMV.
The jurors remain standing, and Chhabria advises that everyone stands for them, but they don’t have to stand for anyone. They smile and take their seats.
PLAINTIFF OPENING STATEMENTS
Wagstaff takes the floor, and sweetly thanks the jury for their service. There is something very familiar about Aimee, like she is a good friend that everyone seems to know. Her manner is smart and professional, but also amiable.
She launches into her slides, which I assumed had been pre-approved by both Chhabria and Monsanto. Alas, the slides were NOT pre-approved. And so we begin a rather controversial, dramatic opening statement.
Wagstaff introduces us to Plaintiff Ed Hardeman and his wife Mary, who dons a cheery, colorfully geometric sweater. Wagstaff lovingly places her arm around Mary while telling the story of their first date. We hear the beginning of the devastating story of Ed finding a lump on his throat on Christmas morning that would ultimately be diagnosed as NHL. Chhabria doesn’t like the prolonged personalization of Ed’s story, and instructs Wagstaff to stick to Phase 1 topics.
Wagstaff works her way through her slides, and covers:
- The planned agenda for Phase 1 of the trial
- Depositions they will see of current and former Monsanto employees, including Bill Reeves, Dr. Goldstein, Dr. Farmer, and Dr. Saltmiras.
I wonder about the employee depositions in Phase 1, because I think Chhabria would lump most of the material into his “Sideshow” category. Meaning, not sciencey enough for Phase 1. Wagstaff continues through the slides. The key points:
- The four ingredients in Roundup – glyphosate, surfactants, water and other byproducts
- Roundup and glyphosate are not the same. Roundup is more toxic than glyphosate alone.
- In determining whether Roundup causes cancer, experts will present testimonies on the “Three Pillars of Science” – Epidemiology, Animal Studies, and Cell Data (or “mechanistic” studies)
- Dr. Ritz will testify on Epidemiology
- Dr. Portier will testify on Animal Studies and Cell Data
- Dr. Weisenberger will discuss Cell Data
Wagstaff introduces the epidemiological studies that Plaintiff will cite as proof that Roundup can cause cancer, including a pre-emptive knock at AHS.
I have to say – if I were a juror, this would all be SO incredibly overwhelming. It’s hard enough for me, and I have not only read these studies, but spent a whole summer hearing them discussed endlessly! As an aside, it concerns me that none of the jurors are taking any notes. One might say they look a little like deer in headlights. I’m not sure that is good or bad, just noteworthy.
Several sidebars are called, and during each, a white noise static is played to cover the voices. The static sound makes me nostalgic – it sounds exactly like the static that would come on in late night in the days of antenna TV, when the stations signed off with the US national anthem and faded into white noise.
Chhabria reminds the jury that what lawyers say should not be considered evidence. The purpose of opening statements is merely to give a preview of what the evidence will show.
Wagstaff continues and explains that toxicological studies will include mouse and rat studies.. Working our way through the mice studies chart, which I recognize from the Johnson trial, we land on the “Magic Tumor” study. Wagstaff delivers a highly detailed, animated description of the shenanigans that went down surrounding that mysterious mouse kidney tumor allegedly found in the control group of the study.
She bolsters her story with a slide of the EPA 1985 correspondence memos regarding their disagreement with Monsanto’s position that glyphosate in non-carcinogenic: “We disagree with the registrants position. The registrant wishes to avoid false positives, while those concerned with the public health wish to avoid false negatives. Hence, for this reason alone, Monsanto’s argument is unacceptable.”
GG Sidebar: WHAT? OK, maybe I’m missing something here – I thought that internal memos from the EPA were off limits given the agreements brokered in the pre-trial hearings. Only highly specified, limited evidence from either EPA or IARC were to be permitted.
Wagstaff continues, unfazed, to describe the Cell Data studies and how Dr. Portier will walk through how a normal cell turns cancerous.
Finally, Wagstaff introduces IARC, describing what it is and the significance of IARC classifications. Chhabria warns her that she is getting into more detail than she is allowed to present in Phase 1. She explains that the EPA only looks at glyphosate and that the “EPA doesn’t actually test…”
Monsanto raises an objection, and Chhabria instructs Wagstaff to move off of the EPA topic.
A break is called, and then hell breaks loose.
CHHABRIA V WAGSTAFF
The jury leaves the room, and Chhabria is furious. He says: “You have crossed the line so many times. [It’s] totally inappropriate with everything we’ve discussed over the last couple of months. If it crosses the line one more time, with respect to Phase 1, if you bring in material during Opening Statements that is inadmissable, your Opening Statement is over. I will tell you to sit down.”
He considers banning the Plaintiff from using slides for the remainder of the Opening.
Monsanto responds that they would prefer that Wagstaff not use the slides. Apparently, Chhabria DID require the parties to submit exhibits before opening for approval. None of the questionable exhibits were in the submission. Chhabria sternly warns Wagstaff that if she says a SINGLE inappropriate thing that shows the same complete disregard for limitations, he will shut her down in front of the jury.
The jury reenters, and Wagstaff completes her Opening Statements, strictly abiding by rules. Apparently, Plaintiff counsel is permitted to include a photo of Hardeman’s property in the Opening, but Wagstaff shows a picture of Hardeman and his family happily posing in a family portrait. Chhabria says to take it down.
I’d like to be clear that Wagstaff’s arguments and presentation were worked on by a team of Plaintiff attorneys, so the decisions of what to include or exclude were made by multiple people.
MONSANTO OPENING STATEMENTS
Brian Stekloff confidently approaches the jury, and begins to very clearly introduce the issues from Monsanto’s perspective. He promises that he, Tamarra and Rakesh will give the jury all the evidence that they will need. The arguments are similar to those in the Johnson trial. I’ll briefly run through them. Monsanto did a better job of staying within the lines, and therefore provided far less less drama.
- None of the plaintiff’s highly trained doctors or comprehensive medical records say that Roundup caused Hardeman’s cancer.
- Hardeman has suffered from Hep C which is a known cause of NHL
- Roundup targets a specific enzyme essential to plant growth
- ROUNDUP DOES NOT ENTER GROUNDWATER
- ROUNDUP DOES NOT STAY IN SOIL
GG Sidebar: Oh my gosh I could scream. SERIOUSLY? Does not enter groundwater or stay in soil? That is so outlandishly false that I am embarrassed for Monsanto. Disgusting lies perpetuated.
I vent to my bench-neighbor Julie from Agence France Presse – it makes me feel a tiny bit better.
- The amount fed to mice and rats in studies is far above any kind of exposure a human would encounter.
- The epidemiology that Plaintiff’s cite does not adequately adjust for other pesticides
- Plaintiff witness epidemiologist Dr. Ritz only became critical of the AHS study after she was hired as an expert for the litigation
- IARC’s classification had no impact on Drs in the US in terms of offering a new cause of NHL. The EPA disagreed with IARC and, subsequently, the EPA has reaffirmed that glyphosate is non-carcinogenic. Europe’s EFSA also reaffirmed that glyphosate is non-carcinogenic.
THOUGHTS FOLLOWING OPENING STATEMENTS
For me, it would be easier to believe Monsanto’s story, as regulators have done for decades. Also, Stekloff is very believable, articulate and rational. He has a very subtle tone of “these claims are so unfounded that this whole trial is a ridiculous exercise.” Quite effective when representing Big Ag.
I need to get more intel on why on earth Hardeman was selected as the first bellwether case in the federal trial. With the complication of Hep C, a KNOWN cause of NHL, how could the jury ever conclude that Roundup caused the cancer? If the jury is smart but uninformed on the nuances of Hep C vs exposure to carcinogenic chemicals as the cause of NHL, it would be far easier for them to conclude that in Hardeman’s case it could have been the Hep C.
I’m still extremely concerned that the jury isn’t taking notes. In the Johnson trial, most jurors were furiously taking notes because the challenge of understanding these studies is no joke.
I’m pondering the Plaintiff’s decision to discuss the EPA in openings. Maybe just to irk Chhabria? Alternatively, it was a carefully calculated strategic risk that will hopefully reap benefits.
The lovely Dr. Beate Ritz enters the courtroom. She sports a black top and a perfectly imperfect salmon-colored cardigan, as if she were a model for Eileen Fisher. Her silver hair is cut in a straight LOB (come on folks, LONG BOB), and her glasses are a smaller versions of Lisa Loeb’s trademark frames.
Dr. Ritz introduces herself, and reveals a delicate accent that we learn is German. She must have learned British English because her English sounds quite posh. When I worked in London, my British coworkers explained to me that Germans and Americans share the same “duckish” sound when speaking. I am still trying to figure out exactly what that means, but I don’t think it was a compliment.
Anyway, Dr. Ritz has numerous impressive academic degrees:
- PhD in Epidemiology from UCLA
- MPH, School of Public Health, UCLA
- Doctoral Degree in Medical Sociology, University of Hamburg
- MD, Registration as Physician
While she has her MD, she didn’t want to be a doctor who just diagnoses and treats. She wanted to find out what causes specific diseases, and decided she could best do so as an Environmental Epidemiologist. She is a practicing Environmental and Occupational Epidemiologist who both teaches at UCLA and has done extensive research on the epidemiology of pesticide use in the richly agricultural Central Valley of California.
The jury breaks for lunch. I wander out of the courtroom and run into AGENT OJ! How could it be that I didn’t know he’d be here? Because the courtroom audience tends to divide on either side of the center aisle depending on which team you are on (similar to bride and groom), I am stunned to hear that he has been residing on the Monsanto side. On the other hand, he had a preferable view of the jury. I mostly stared at the back of someone’s head and a distant, blurry screen. My peripheral vision also caught a lean, older man who spent the morning wide eyed, uncomfortably staring past me to the Monsanto audience with a cynical eye. It felt similar to when a child that isn’t mine stares back from the airplane seat in front of me.
We return to the courtroom and settle in for an excellent session of Epidemiology 101 with Dr. Ritz. Chhabria gets down from his seat and stands closer to the presentation, which is accessorized with an enormous write-on poster with a list of epidemiology studies to consider. Because the content of her lecture is not particularly dissimilar to that of Dr. Neugut and Dr. Mucci from the Johnson trial, I won’t go in depth on her presentation.
However, one point that is critical and new is her explanation of why Statistical Significance is not the be-all, end-all measure when reaching study conclusions. Ritz presents the 2010 study The ongoing tyranny of statistical significance testing in biomedical research. The study abstract states:
“As in the social sciences, the tyranny of statistical significance testing (SST) is still highly prevalent in the biomedical literature even after decades of warnings against SST. The ubiquitous misuse and tyranny of SST threatens scientific discoveries and may even impede scientific progress. In the worst case, misuse of significance testing may even harm patients who eventually are incorrectly treated because of improper handling of P-values.”
I love the description of SST being ”tyrannical”. Avoid the tyranny by instead going beyond SST and thinking more about the overall context of the literature.
Ritz gives an example of achieving a greater level of clarity by adding more details to a study. She opens into an example of smoking and cancer – I’m shocked because I thought there was an order to not discuss the tobacco industry. Perhaps it is permissible in this case because the epidemiology of smoking is an appropriate case study that can be applied to many other cases.
If an epidemiological study is a “Never/Ever” study, that means that someone who smoked a few cigarettes for a few months, but subsequently quit, would be lumped into the same category in the study’s analysis as someone who smoked three packs a day for 40 years. However, if one divides cases into groups pending on how much they smoked, one would be able to determine if there is a “Dose Response” to smoking. The lesson? Dose Response studies can be extremely helpful if one has enough data.
Wagstaff and Dr. Ritz run through the list of epidemiological studies to support carcinogenicity of Roundup:
- Hardell 1999 https://www.ncbi.nlm.nih.gov/pubmed/10189142
- Hardell 2002 https://www.ncbi.nlm.nih.gov/pubmed/12148884
- McDuffie 2001 http://cebp.aacrjournals.org/content/10/11/1155.long
- DeRoos 2003 https://oem.bmj.com/content/60/9/e11.long
- Erikkson 2008
- Orsi 2008 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2728754/
- NAPP – North American Pooled Project
With that, we are a few minutes past the 2:30 end time, and the AHS study is saved for tomorrow. The jury exits, but we all remain.
- Dr. Portier’s video testimony has not been fully edited nor has Chhabria looked it over for content approval. Showing the video tomorrow looks like a no-go. Plaintiff suggests that they play depositions of Dr. Ross, Dr. Goldstein, and Dr. Blair while they edit the Portier testimony. However, no transcripts have been submitted yet for the proposed Blair and Goldstein testimony, making it hard to admit them for viewing tomorrow.
- Monsanto raises the issue of Wagstaff describing the Magic Tumor study in unexpected detail in opening, and suggests restrictive statements to be made when presenting the story going forward.
- Chhabria firmly states that the Magic Tumor slides that Wagstaff presented, including the questionable EPA memos, was “clearly inappropriate.” He continues that it is not the first time a dispute was teed up and the Plaintiff didn’t wait for it to be resolved before acting upon it. This accusation must be in reference to the Monsanto Papers released by Plaintiff in 2017.
- Chhabria tentatively sanctions Wagstaff with $1000 for “transgressions” and says that the entire team may be sanctioned.
- Chhabria goes into stream of consciousness mode: “One of the big questions running through my mind is has she completely forgotten the forest for the trees. The plaintiffs moved to exclude EPA documents, but then went an quoted EPA documents…it’s incredibly dumb…Are the plaintiffs so intent on committing misconduct that they are unaware they are opening the door to bad evidence for them? They may have opened the door to the later EPA documents.
- One juror experienced unexpected financial hardship that changed his status of being available to serve. He was excused from duty. We are now down from nine jurors to eight, and two men to one.
- So sleepy, please excuse any sloppiness. I may be delayed in publishing Tuesday’s update – hoping to have time!
© 2019 Kelly Ryerson ALL RIGHTS RESERVED