Day 9 – Roundup, Hep C, Both or Neither?
The courtroom is oddly packed today – the Monsanto side is sardined with observers. Perhaps more people are in town given today’s lead-up to the Closing Statements. During Johnson’s Closing Statements, several dark suited, gel-haired men showed up to linger in the halls. They reminded me of John Travolta and his Scientology crew. I presume they must have been Monsanto security of some kind, though I don’t think of that look as typical of St. Louis.
Judge Chhabria announces that Closing Statements will take place tomorrow morning, and that both teams should be prepared for Opening Statements on Phase 2 on Wednesday morning.
The jury enters, looking refreshed from the weekend. Two women are inspired to sport the cardigan and crewneck versions of the same lime green sweater, and our lone man wears his black hooded jacket. I don’t get the sense that this jury is particularly tight. On the other hand, I haven’t had a chance to watch them because Chhabria enforces the rule of the audience sitting in the courtroom for five minutes after the jury is dismissed.
Today will be pivotal as Monsanto seeks to establish that Hardeman’s Hep C and Hep B most likely caused his Non-Hodgkins Lymphoma. Monsanto’s expert witness Dr. Levine takes the stand, picking up where we left off on Friday.
EXPERT TESTIMONY OF DR. LEVINE CONTINUED
Hematologist and oncologist Dr. Levine presents herself confidently, with a seniority that emanates from her significant professional experience and low, unfailingly steady voice. I get the impression that, in her academic work, she is strictly orthodox and difficult to persuade away from status quo medical textbooks. I’d take a gander that she would likely reject Hippocrates’s admonition to let food be thy medicine and medicine be thy food. Levine seems more pharmaceutical in approach, which perhaps I just assume as she is an expert for Bayer.
Stekloff performs the direct, and we hear more about Levine’s awards and accolades, particularly for her global consulting work on the treatment of AIDS. For good measure, Levine talks a bit about her commitment to promoting women in medicine. She acknowledges that outside of Dr. Mucci’s expert report, she knows little to nothing about pesticides.
WHAT IS CANCER:
In an extraordinarily clear exposition with simple but effective visual aids, Levine explains what causes cancer. The jury perks up and takes copious notes. We learn that cancer cells originate from an “accident”, or mutation, in their DNA. The mutation tells the cell to divide uncontrollably. There are several known causes of such mutations, including radiation, tobacco, and certain viral infections (such as Hepatitis C).
More specifically, cancer requires two defects to take hold in the body. First, it needs a DNA error in a cell, leading to uncontrollable division. Second, the immune system must fail to recognize and destroy the cancerous cells. As we age, our immune system gets weaker, and cancer is more likely to take hold. For someone suffering from Hepatitis C (such as the plaintiff Hardeman), the virus can mutate cellular DNA, but full-blown cancer may not emerge for many years.
LEVINE TALKS HARDEMAN
Hardeman suffered from Diffuse Large B-Cell Lymphoma (DLBCL), the most common type of NHL. NHL is a cancer of the immune system, with over sixty different types, all with different treatments and prognoses. Prior to the trial, Dr. Levine looked over Hardeman’s medical records and the testimonies of his three treating physicians.
Levine criticizes Dr. Weinsenberger’s differential diagnosis of Hardeman’s NHL. She argues that, in medicine, a differential diagnosis is used to figure out what the medical diagnosis is, not what caused the cancer. She has never heard of another oncologist performing a differential diagnosis in this manner, nor does she find it a scientifically valid method to decipher the cause of Hardeman’s cancer. I am pleased that she raises this point, because I have been wondering about that terminology. As it turns out, in toxic tort litigation, a “differential diagnosis” is a method whereby a plaintiff’s expert purports to “rule in” various potential causes for the plaintiff’s illness and then to “rule out” alternative causes until only one remains.
I’m not sure why Stekloff takes Levine down this path of nomenclature debate, but we travel alongside and move on to hear Dr. Levine’s thesis statement. She says that, without a question, the most likely cause of Hardeman’s NHL was his chronic Hepatitis C that he suffered from for 39 years. Hep C is a well-proven cause of Diffuse Large B-Cell Lymphoma. She claims that the second most likely cause is Hep B, because it also causes accidents in DNA. Finally, if not Hep C or B, she considers the cause idiopathic. About 70-90% of NHL (and DLBCL) cases are such that we don’t know the causal reason.
Levine begins speaking almost robotically, as if she has memorized a script of some kind. Little emotion or fluctuation in her voice, she seems to have been highly trained not unlike the other Monsanto expert witnesses.
When discussing idiopathy, Levine notes that her own patients are more likely to have NHL with a known cause like HIV, Hep C, or Hep B because her area of expertise is NHL caused by infectious organisms.
LEVINE TALKS HEP C
I knew very little about Hep C until today, so am thankful that Levine taught so clearly as to make it considerably easier to recap.
Hepatitis C is an RNA virus. In about 15% of cases, a patient can clear Hep C just with his own immune system. The other 85% of cases gets a chronic infection that can lead to cirrhosis of the liver. Hepatitis C can directly cause harmful DNA mutations, or “accidents” as they are referring to them during this testimony, in white blood cells, or lymphocytes.
In Hardeman’s specific case, he was infected by Hep C in 1966 but was undiagnosed until 2005. By the time of diagnosis, his Hep C was chronic. As a result of his long-standing chronic infection, (as described on a board that rudely has its back to me once again), he suffered from both cirrhosis and lymphoma (cancer of the white blood cells).
We learn that even if antivirals were taken to rid Hardeman of his Hep C to a level that made it undetectable in the blood, permanent damage to the cells may have already occurred in the preceding 39 years of chronic disease. Levine calls this DNA accident a “Hit and Run,” because while the Hep C is no longer present, the DNA damage from the virus has already happened. There can be a very long latent period during which the mutated cells are starting to divide aggressively, but the immune system is strong enough to keep them in check. As the immune system weakens with age or disease, the cancerous cells gain the upper hand and the patient develops full-blown lymphoma.
Frighteningly, the “Hit and Run” model is true of smoking as well. Now I’m thinking back to college when I enjoyed a cig on occasion with drinks. It takes me a few moments to refocus.
LEVINE TALKS DR. YE
Levine talks through the reports and deposition of Hardeman’s treating physician Dr. Yee. Because Hep B and Hep C can be reactivated during chemotherapy, Dr. Yee decided to treat Hardeman with a drug to prevent any potential relapse. Levine uses this to prove that these types of RNA viruses are never completely gone, but just go into remission.
Dr. Levine further argues that we may not see active Hep infection in the blood after antiviral treatment, but peer-reviewed literature shows that ultrasensitive studies can often find Hep C lurking as an “occult,” or hidden, infection. Regardless of whether occult or not, the Hit and Run permanent damage that set off the NHL could have occurred at any point since the original Hep C infection.
CROSS EXAMINATION OF DR. LEVINE
Plaintiff attorney Jennifer Moore is up for the cross.
For the next forty-five minutes, we see a new side to Levine. Her calm, polite, and enviable bedside manner is replaced by a harsh edginess. Moore’s questioning, while moderately challenging in content, is never especially aggressive. Levine’s tone feels unwarranted and almost humorously disproportionate. This scene triggers a memory from my high school English days:
Fair is foul, and foul is fair;
Hover through the fog and filthy air.
I also visualize a cat and a broomstick.
I’m pleased by this turn of events, because if any of the jurors have ever had a super strict, unbending, and scary teacher, this episode is sure to trigger some PTSD. In my own case, I flash back to Ms. May in 8th grade, who humiliated me as I read my creative writing essay in front of the class. She was so incredibly disgusted by my use of the lackluster adjective FUNFILLED that she had me stop reading and sit down. Maybe I write today in an effort to make up for that moment of humiliation…hmmmmm… at any rate, you won’t ever read the word funfilled in any of my pieces.
Chhabria calls for a brief break, and when we return, I am convinced that Monsanto told Levine to smile more and change her tone to non-scary. When we start back up after break, Levine is still exacting in her words, but considerably softer. Kind Dr. Levine has returned, with some nice smiles to the jury. Serving as an expert witness on behalf of Monsanto is an extraordinarily stressful proposition that could certainly make one more intense than usual. God only knows what they do to their experts who fail on the stand. I’d like to think that this nice version of Dr. Levine is the accurate one.
Highlights from an excessively long cross-examination:
· Levine is not aware of pesticides as a known risk factor of NHL. She says it is not her specialty and avoids the questioning. Moore points out the American Cancer Society notes that chemicals such as herbicides and weed-killing substances may be linked to NHL. Levine did not consider pesticides in her analysis.
· Moore asks Levine if she knows that herbicides are a type of pesticide, and Levine answers that she does not. Moore confirms with Levine that she is here to testify as an expert witness for Monsanto. “You understand that Roundup is Monsanto’s product. They are paying you to be here.”
· A juror in the front row appears to have her eyes closed. Oh, they are open again. Now Chhabria is yawning.
· Moore spends the late morning and afternoon quizzing Levine on research that Weinsenburger used to argue that once Hep C is treated, the likelihood of getting NHL significantly decreases. Levine continues to argue her quite valid “Hit and Run” theory and backs it up firmly with different components of the same studies that Weinsenburger presented. After an hour plus of Moore questioning Levine on the studies, I wish Plaintiffs had just called off the cross and not served up spike after spike for Levine to smash back right at them.
· Levine strongly holds her ground as Moore determinedly tries to penetrate or weaken her testimony. Levine doesn’t budge from her original, believable thesis statement (that the Hep B or Hep C ultimately caused Hardeman’s lymphoma), and her supporting arguments and cited data are perfectly in order. That’s why it would be hard to be her student.
We’ve spent an entire day with Dr. Levine. We heard directs and crosses ad nauseum, with little new information after the direct. Sadly for the Plaintiff, Dr. Levine is successful in painting an extremely compelling case that Hepatitis C/B is the most likely cause of Hardeman’s NHL. In fact, she is so incredibly convincing that now I am thinking that it likely did as well. Furthermore, this second to last testimony will be fresh in the minds of the jury upon deliberation.
The terribly unfortunate complexity of Hardeman’s case is that while Roundup could indeed have caused his cancer, there is such an undeniable wealth of solid research to support the argument that Hep C can cause his specific DLBCL. Seeking an alternate explanation, such as Roundup exposure, is such an incredibly hard argument to make just by virtue of having to convince the jury to tour the contentious glyphosate-as-a-carcinogen territory.
EXPERT TESTIMONY OF DR. DANIEL ARBER
A friendly-seeming man with a thick swath of silver hair takes the witness stand. Dr. Arber is the Chair of Pathology at University of Chicago. He’s held some gangbuster, impressive positions, including a long stint at Stanford as an award-winning medical school professor and Vice Chair for Clinical Services.
Dr. Arber gives a mini-physiology lesson on the Lymphatic System, B-Cells, T-Cells and lymphoma. With slight variance from Dr. Levine’s earlier testimony, Arber says that 90% of lymphomas are generally idiopathic.
He briefly discusses the steps that he takes in attempting to establish causation.
Arber is cut short as the trial day finishes, but will continue testimony tomorrow.
After the jury leaves, we take a short break and then reconvene to hear about jury instructions for the Phase 1 deliberations that will kick off tomorrow. The wording in the instructions is of utmost importance to both parties. Regarding causation, the predicament is that a juror (or people like me) might easily conclude that both Hep C and Roundup could have caused Hardeman’s NHL. Monsanto, of course, wants the causation question to be a polarized in a “but/for” format: But for the action, the result would not have happened.
The problem with the but/for is that there are two potential actions that could have landed Hardeman in the same result. There was some truly rigorous debate between the parties, and Chhabria moderated the debate fairly and helpfully. After listening to the debate for 45 minutes, I had to hit the road or else my commute would go from 40 minutes to 75 minutes.
Tonight, Chhabria released the Court’s Revised Phase 1 Instructions – 3/11/2019. He seeks comments from both parties by 10pm tonight. The full list of instructions can be found on the Federal Trial Homepage at the bottom of the posted list.
Of specific interest, Chhabria writes the following on Causation:
INSTRUCTION NO. 9: CAUSATION
To prevail on the question of medical causation, Mr. Hardeman must prove by a preponderance of the evidence that Roundup was a substantial factor in causing his non- Hodgkin’s lymphoma. A substantial factor is a factor that a reasonable person would consider to have contributed to the harm. It must be more than a remote or trivial factor. Subject to the additional instructions below, conduct is not a substantial factor in causing harm if the same harm would have occurred without that conduct.
The following additional instructions apply if you believe that two or more NHL-causing factors operated independently on Mr. Hardeman:
If you conclude that Mr. Hardeman has proven that his exposure to Roundup was sufficient on its own to cause his NHL, then you must find for Mr. Hardeman even if you believe that other factors were also sufficient on their own to cause his NHL. On the other hand, if you conclude that Mr. Hardeman has not proven that his exposure to Roundup was sufficient on its own to cause his NHL, then you must find for Monsanto.
So, tomorrow we’ll see Dr. Arber finish testimony, both sides present Closing Statements, and the jury sent off to deliberate. The verdict could come at any moment, even Thursday when there usually is no trial.
Major insomnia tonight – I will be so grateful if the jury makes the right decision. Phase 2 would just be entertaining icing on the cake.
© 2019 Kelly Ryerson ALL RIGHTS RESERVED