Update: Live Updates from Cancer Victims V. Monsanto Hearing

Dr. Mucci’s cross exam is complete, and that’s a wrap for testimony for glyphosate Science Week. Judge Chhabria calls for a round of applause for the court reporter; “we can all agree she had the hardest job in the room this week.” Oral arguments are set for Weds at 10 a.m.

Today, the last two witnesses presented: Dr. Chadi Nabhan for the plaintiffs (he couldn’t get here until today) and Dr. Lorelei Mucci for the defense. Dr. Nabhan is an oncologist who serves as medical director of Cardinal Health and has 17 years of clinical practice and academic research focused on lymphomas.

Dr. Nabhan discussed the process by which the International Agency for Research on Cancer conducts its monographs to determine whether chemicals cause cancer. The agency has a high bar to consider what it reviews, he said – exposures must be high and animal data strong. Since 1965, IARC has reviewed 1003 agents and found 20{5fc40a96f14c4a6aa4c2a32569b0a57dcc67c0b31eb04c341474283f11b6cdd2} to be carcinogens; 120 classified as carcinogenic and 81 classified as probably carcinogenic, including glyphosate.

“In my opinion, the (NHL) risk (of glyphosate exposure) is clinically significant enough that patients should be aware of it,” Dr, Nabhan said. “The IARC report is very convincing.”

Dr. Nabhan does not have a high opinion of the Agricultural Health Study (AHS) that was the topic of much of today’s discussion. “There are so many flaws in this study that it’s impossible to draw any conclusions,” he said. He shrugged off the updated analysis is “an updated analysis of an already flawed study.”

Last up was Dr. Lorelei Mucci for the Monsanto defense. Dr. Mucci is an associate professor of epidemiology at Harvard T.H. Chan School of Public Health and assistant professor of medicine at Harvard Medical School. Her major research and teaching area is cancer epidemiology.

Much of Dr. Mucci’s testimony focused on the importance of the AHS study, with a lot of back and forth and questions from the judges about the validity of self reporting in the questionnaires about glyphosate exposures. Dr. Mucci’s opinion, based on her review of AHS and all the available epidemiological data, is that there is no evidence of positive association between exposure and NHL risk and no evidence of dose response.

In cross examination, Dr. Mucci clarified that her opinion is based on the epidemiological data only and she did not look at toxicological data or animal data.

Entering the final inning of Science Week as the plaintiff’s attorney is about to begin cross examination of cancer epidemilogist Dr. Lorelei Mucci, an associate professor of epidemiology at Harvard T.H. Chan School of Public Health. Last witness! More updates soon from the testimony of Dr. Mucci and earlier testimony by plaintiff’s witness Dr. Chadi Nabhan, a board certified clinical medical oncologist and past assistant professor at the University of Chicago.

I had to jet off to another city but here is the transcript from March 7’s hearing, https://usrtk.org/wp-content/uploads/2018/03/Transcript-hearing-March-7-2018.pdf and here is the transcript from Thursday’s events https://usrtk.org/wp-content/uploads/2018/03/Transcript-for-Daubert-Hearing-March-8-2018.pdf

Colleague Stacy Malkan is headed to court today to keep you all informed!

UPDATE – Dust up after court adjourns: Plaintiffs’ had provided Monsanto attorneys with a copy of the slide deck they were using for Portier’s direct testimony. But when court adjourned in the middle of testimony, they wanted the slide deck back – or at least the portions they had not yet covered. Monsanto attorneys having their game plan overnight was “prejudicial” plaintiffs’ attorneys protested. But Monsanto attorney Eric Lasker shrugged off the request from plaintiffs’ attorney Aimee Wagstaff that they return the slide deck. A Monsanto attorney had already walked out with the documents and Lasker was not inclined to try to retrieve them. A frustrated Wagstaff requested “judicial assistance” from the judge but retreated after Lasker said they had written notes on the slide deck and refused to give them back.

A long day of testimony wrapped up with plaintiffs’ expert witness Chris Portier laying out for the court detailed and highly technical methodology and analysis that he said supports his views that glyphosate has a strong causal connection to non-Hodgkin lymphoma.

Monsanto has criticized Portier for pooling results from multiple research studies in ways that are aimed at intentionally generating data that favors plaintiffs’ claims against Monsanto, but Portier denied that bias in his testimony Wednesday.

The scientist explained such things as “latency” to the court, and discussed his “sensitivity analysis” of studies done in rats and mice in the 1980s and 1990s.

More direct testimony is slated for Thursday morning from Portier and then his cross-examination. After that, Monsanto will likely get its turn to present its own experts to the judge. The company has said they will present four witnesses.

After this week’s testimony, lawyers for both sides will get their chance to make oral arguments to the judge sometime in the next two weeks. The judge will make a ruling on whether or not the plaintiffs’ witnesses who are providing their scientific opinions regarding causation will be permitted to testify at trial.

The focus for the judge’s decision is whether the experts are using recognized, reliable methodology to arrive at their opinions. If he determines any or all of the witnesses are not relying on this proper scientific foundation he can exclude them from testifying, a move that would be a powerful blow to plaintiffs’ case and a win for Monsanto.

I am sorry to say I have to head to New York City on Thursday, and so will miss the final two days of testimony. But USRTK will be making transcripts available and the video recording of the full hearing when the web link becomes available after the conclusion of this week’s events.

A little bit of legal drama in afternoon testimony by plaintiffs’ expert witness Bill Jameson as Judge Vince Chhabria repeatedly admonished Monsanto lead attorney Joe Hollingsworth over his tactics in cross examining Jameson.

Chhabria seems especially vexed by Hollingsworth’s effort to open a line of questioning by asking Jameson about statements he made in a deposition. The judge told Hollingsworth multiple times throughout the cross examination to ask Jameson directly what his opinions about the science are now, and then if that contradicted something he said earlier Hollingsworth could explore the contradiction. He also criticized Hollingsworth for talking over Jameson as he tried to answer questions.

The judge showed noted concern over the possibility that Monsanto might be taking expert statements out of context. That concern was underscored when, in a particularly stern move that left plaintiffs’ attorneys giddy with delight, Judge Chhabria ordered Monsanto’s attorney to read aloud into the record two pages of testimony from a deposition that supported the expertise of Jameson’s analysis before he would allow Hollingsworth to introduce a separate example from a deposition that undercut Jameson’s expertise.

Hollingsworth protested the action but finally capitulated as the judge insisted. He then ended his cross examination of Jameson.

As Jameson’s testimony ended and he stepped down from the witness stand, he turned to the judge: “Thank you for the honor, your honor,” he said.

Following Jameson, Chris Portier, another in the line-up of plaintiffs’ expert witnesses, took the stand. Portier, who traveled from his home in Switzerland to testify, expressed a bit of nervousness before beginning his testimony under direct examination from New York-based attorney Robin Greenwald.

Portier introduced his expert view that the probability that glyphosate cause non-Hodgkin lymphoma is “high.” 

In his testimony, Portier tacked the Greim 2015 study, which Monsanto and supporters have said supports their position that glyphosate doesn’t cause cancer. ( Internal Monsanto documents state the Greim paper was ghost-written by a Monsanto scientist.) Portier said the work was poorly documented, providing only summary data and not providing individual animal data, among other short-comings.

Following a short break for lunch, Monsanto attorney Joe Hollingsworth stepped up to cross examine plaintiffs’ expert witness Bill Jameson.

Hollingsworth launched his cross by pressing Jameson about distinctions between hazard and risk assessments, and comments Jameson made in a deposition.

They judge admonished Hollingsworth and suggested that rather than continuously asking Jameson about what he said in a deposition, the attorney should ask him about what he actually thinks.

“Why don’t you ask his about his opinion now, the judge told Hollingsworth. “That’s normally how we do it,” the judge said.

Hollingsworth did adjust his inquiry but when again asking Jameson about comments he made in a deposition led Jameson to reply that in his depositions taken by Monsanto “I’ve been misquoted and things have been taken out of context so many times… ”

When Hollingsworth continues to press Jameson to address comments Hollingsworth says Jameson made in a deposition, the judge again interrupts to admonish Hollingsworth, say that if Hollingsworth wants to ask Jameson questions about prior deposition testimony in the way that he is asking then Hollingsworth must provide him the full transcript of the deposition and the page number that contains the comment.

The Monsanto attorney say he has the comment available on a slide to show Jameson and the court. The judge tells him that is not good enough. The witness has to be able to see the comments in context, not pulled out on a slide, the judge tells Hollingsworth. Jameson is then allowed to find and read aloud his full comment.

Repeatedly the judge seems to take issue with Hollingsworth’s style of questioning, including saying it is “his fault” for talking over Jameson as the witness tries to answer questions.

Testimony by toxicology expert Bill Jameson on Wednesday sparked early objections from Monsanto attorneys as the former government scientist explained the body of research that led him to conclude that glyphosate and glyphosate-based herbicides (like Roundup) can cause non-Hodgkin lymphoma at real-world exposures – levels farm workers and others face when using the weed killer. Judge Vince Chhabria overruled Monsanto’s objections.

Jameson was a member of the working group of the International Agency for Research on Cancer  (IARC) which analyzed research on glyphosate and declared it to be a probable human carcinogen in March 2015.

Judge Chhabria posed several questions to Jameson about that IARC finding, noting that in human studies the IARC group concluded there was “limited” evidence of carcinogenicity, compared to “sufficient” evidence in animal research.

That led Jameson to explain that some scientists on the IARC working group thought the evidence was stronger than limited but others disagreed. Jameson joked: “If there are three epidemiologists in a room and you ask them their opinions you’ll get four opinions.”

He, like the scientists who testified Monday and Tuesday, said it is the weight of the combined animal and human data that demonstrates the carcinogenicity of the herbicide.

There are many animal studies on glyphosate, Jameson testified, saying that it is “extraordinary” to have so many animal studies to evaluate a chemical due to the cost of such studies. The fact that researchers have as many animal studies as they do for glyphosate adds to the strength of his conclusion that the chemical causes cancer, he said. Importantly, the animal research shows there is replication of several tumor sites, including liver tumors and malignant lymphoma, he said.

“We had a lot of replication for malignant lymphomas in the mouse,” he said. The same tumors were seen in different studies in different labs at different times, which underscores strength of conclusion of carcinogenicity, he said.

In her questioning of Jameson, plaintiffs’ attorney Aimee Wagstaff at one point presented a slide showing a page from an eight-hour deposition of Jameson, pointing out that Monsanto had only provide the judge with one small segment of Jameson’s actual statement regarding the data. The entire statement provided the needed context for the court, she said.

See transcript here from Tuesday’s proceedings: https://usrtk.org/wp-content/uploads/2018/03/Monsanto-Daubert-hearing-transcript-180306VC.Vol_.2.pdf

Day three of the Roundup cancer “science week” hearing opened with a gift from Judge Chhabria to plaintiffs – a gift of time. The plaintiffs will have an extra 60 minutes to present their expert witness testimony added to the total of 11 hours each side has been allotted for this week’s events. The judge said because he has frequently taken up some of plaintiffs’ time with questions of witnesses, he decided the extra time was warranted. Plaintiffs had requested an additional 90 minutes. Monsanto is not due any extra time, he said.

The judge also noted that he had received an email message from a “citizen” regarding the proceedings, but that he had elected not to read the message. He did pass copies of it to both plaintiffs’ and Monsanto’s attorneys.

The hearing Wednesday began with a continuation of Monsanto’s cross of plaintiffs’ witness Alfred Neugut, an expert in epidemiology who is a practicing medical oncologist and professor of cancer research and professor of medicine and epidemiology at Columbia University.

Monsanto attorney Eric Lasker pushed Neugut on his position on the science, and repeatedly challenged the scientist’s memory regarding previous statements and analysis that the attorney portrayed as conflicting with his testimony in these events. Neugut at one point said he must have been mistaken before but was now correct.

Following Neugut’s testimony, the focus of the hearing today will move from epidemiology to toxicology research that plaintiffs’ cite as evidence backing their claims that Monsanto’s weed killer causes cancer.

The first toxicology expert to take the stand will be Charles Jameson (who goes by Bill). Jameson has served as program leader for the National Toxicology Program at the NIH’s National Institute of Environmental Health Sciences for 12 years. He was a member of the working group for the International Agency for Research on Cancer that found glyphosate to be a probable human carcinogen in March 2015.

With the turn to toxicology will likely come a turn to discussion of the 1983 mouse study that initially prompted EPA scientists to say the study showed evidence of glyphosate’s cancer-causing potential. It was only after pressure from Monsanto and a report from a pathologist hired by Monsanto – and years of discussions with EPA – that the official assessment of that study was changed to reflect no sign of carcinogenicity.

Monsanto sought to keep much of the data from that study out of court after plaintiffs said they would be introducing it, but the judge has said the study data will be allowed as evidence.