Roundup Trial and Peculiar Episodes

During the first federal class action case against Monsanto/Bayer for allegedly causing Non-Hodgkin Lymphoma (NHL) through use of a glyphosate based herbicide such as Roundup, two episodes stood out as peculiar. Both were rehearsed attempts attacking credibility of defense’s epidemiological expert, Lorelei Mucci, with a large assumed risk of back-firing before assembled jury in a very high stakes trial.

The first episode originated during Q & A session between plaintiff’s lawyer and plaintiff’s epidemiological expert, Beate Ritz(trial transcript):

Q. All right. So are you familiar with the epidemiologist that Monsanto has designated in this case? A. Yes, I am. Q. Dr. Mucci and Dr. Rider; correct? A. Right.Q. Are either Dr. Mucci or Dr. Rider an environmental epidemiologist? A. No, they are not. Q. And what is the significance of that with respect to an opinion that they would give in this case? A. Dr. -­MS. MATTHEWS: Objection. THE COURT: There is an objection. MS. MATTHEWS: Objection to collateral use of -­THE COURT: Overruled. BY MS. WAGSTAFF Q. You can answer. A. Okay. So these are two young colleagues who are specialists in a different field. It sounds like epidemiology that should encompass every epidemiological study or every study of human health, right. But we have branches, and the branch that Dr. Mucci and Rider are specialists for are molecular epidemiology. That is a very technical term, but what they mostly know to do is to test cells and to test genetic factors that contribute to disease, to cancer. And they also have — so it is much more a — it is much more detailed in terms of the technology, but they have no training or no specialty in going out into the field, which I do, and asking people about their work or their environmental exposures. It is really hard to capture environmental and occupational exposures over a lifetime and, therefore, we are a specialty. And that’s not what these two do. They have never done that.

The second part of the episode included a question and answer session during defense’s lawyer direct examination of Lorelei Mucci after plaintiff finished their case:

Q. Now, have you ever met a Dr. Beate Ritz? A. I have not. Q. Well, she was here last week and she testified, and she said that you were a “young colleague who had no training, no specialty in going out into the field or asking people about their work or their environmental exposures.” Let me ask you: Is that accurate? A. No, that is not correct. Q. Please explain. A. So for the — I have worked as on epidemiologist for the past 16 years and have been involved in a number of different studies collecting information from individuals participating in these studies. And most recently I’m leading a global study of prostate cancer patients where we are asking the patients about environmental exposures, what lifestyle factors they are engaged in, what medications they are taking and what their quality of life is. So I have been very engaged in collecting data from a range of different patient populations. Q. Okay. And in this study is it across many countries? Is it just here in the United States or is it across many countries? A. So this study is being conducted in the United States and in nine other countries around the world. Q. Involving how many men? A. So we are recruiting 5,000 men for this study. Q. Tell us the different types of cancers that you have been involved with researching as a cancer epidemiologist. A. I have been studying several different types of cancers throughout my experience. I have worked in the areas of breast cancer and prostate cancer. I have looked at colorectal cancer. Liver cancer. I have done some work also in childhood cancers, really several different cancer types.

Doubling down during the subsequent cross examination of Mucci, plaintiff’s lawyer alleged Mucci was subject of congressional investigation while serving on an Environmental Protection Agency advisory panel in 2008:

Q. Okay. And, Dr. Mucci, this isn’t the first time that you’ve said that there’s no risk of a cancer from a chemical despite what the scientific literature says; is that right? MS. MATTHEWS JOHNSON: Objection to the form. THE COURT: Overruled. THE WITNESS: I’m not sure what you’re referring to specifically. BY MS. WAGSTAFF: Q. Okay. Isn’t it true that in 2008 you were under a congressional investigation for saying that a toxic chemical was not a cancer risk even though the available scientific evidence refuted those statements? MS. MATTHEWS JOHNSON: Objection, Your Honor. May we have a sidebar briefly? THE COURT: Sure. (LATER AFTER SIDEBAR FINISHED) BY MS. WAGSTAFF : Q. All right. Dr. Mucci, were you a member of the acrylamide EPA panel?A. Yes, I was. Q. All right. And I’ve handed you a letter that is dated March 13th, 2008, and it is from the United States House of Representatives Committee on Energy and Commerce. Do you see that? A. Yes, I do.Q. And it’s written by Chairman John Dingell and Chairman Bart Stupak, the Subcommittee of Oversight and Investigations. Do you see that?A. Yes, I do.Q. And have you seen this letter before? A. I have not, no.Q. All right. And so this letter, if I can direct you to the second page, paragraph 5. And this is a letter setting forth a congressional investigation; is it not?A.So I’m not sure what this letter is since I’ve never seen it before, but I could tell you a little bit about the — that committee and also my past research; but, you know, I have not seen this letter previously.Q. Sure. And in paragraph 5 it says “Lorelei Mucci.” Is that you? A. Yes, it is.Q. Okay. And it says — and this is some congressmen writing to the — looks like the EPA and stating that — it says at the beginning (reading): ”In reviewing this matter, we note that a number of EPA panels assessing the human health effects of toxic chemicals” -­Let me put this on the Elmo.Congress says (reading): “In reviewing this matter, we note that a number of EPA panels assessing the human health effects of toxic chemicals” -­THE COURT: I’m going to interject.MS. WAGSTAFF: Okay.THE COURT: If you’re going to ask questions about this document, you need to describe it accurately.MS. WAGSTAFF: Okay. THE COURT: This is not Congress saying anything.MS. WAGSTAFF: All right.THE COURT: This is an individual member of Congress — two individual members of Congress saying something. So I need you to describe this accurately or I will cut off the line of questioning. MS. WAGSTAFF: Okay. Sure. Q. So this is two members of Congress asking the EPA, and they state (reading):”In reviewing this matter, we note that a number of EPA panels assessing the human health effects of toxic chemicals have included individuals alleged to have pecuniary interests in the chemical industry.”Do you see that? Did I read that correctly?A. Let’s see…(Witness examines document.) And could you define “pecuniary”? I’m not familiar with that word.Q. Financial interest. A. That would be absolutely incorrect. I had no financial interest in the study of acrylamide that was formed in the formation of food. There was absolutely no financial interest that I had.Q. Okay. And it says, “We note, for example, the following,” and it lists nine people, and. Then we go to Number 5, and you had told me that that is you, Lorelei Mucci, and it says (reading):”Lorelei Mucci sits on the EPA acrylamide panel, but has made the following statements, each of which can be refuted with the available scientific evidence, prior to her selection on the panel.”Do you see that? A. Yes, I do. And, again, if I could clarify the work that I’ve done on this topic of acrylamide, that may be helpful in giving some context for this. Q. Sure. Absolutely. I just want to get through this paragraph. And so the two members of Congress tell the EPA that your statements, which can be refuted with the available scientific evidence, are as follows (reading): ”One, there is little evidence of an association between acrylamide from any specific baked or fried potato product and cancer risk; two, the levels of acrylamide individuals are generally exposed to through food do not appear to increase the risk of cancer; and, three, the intake of acrylamide, no matter how much is consumed, is not a breast-cancer risk factor.”Did I read that correctly? A. Yes, you have. And so, again, if I could provide some context.Q. Sure. A. I was a post-doc in 2002 in Sweden when the Swedish Food Administration first found that acrylamide, which is a compound that was formed naturally during cooking practices — so, for example, baked potato products and breads have levels of acrylamide — and so as a post-doctoral fellow, I did research using a number of both case-control and cohort studies investigating whether the amount of acrylamide that people were consuming in their diets increased the risk of several different cancers, including breast cancer.These particular quotes are coming from the manuscripts that I had published on this topic. Those reports were funded by actually the U.S. Army Breast Cancer Program and the National Cancer Institute. There was no suspicious funding at all in any of the studies, and these particular quotes come from the publications. And, in fact, now — you know, this letter was written in 2008 — in 2019 it’s generally accepted by most scientists that the amount of acrylamide that people are exposed to in diet is not a risk factor for cancer, and that’s the current state of evidence in 2019. Q. Okay. Well, I don’t want to get into a side trial of whether or not acrylamide is cancerous or not, but based -­back to this letter, these two congressmen were saying that your statements could be refuted by available scientific evidence. Did I read that correctly? A. Yes. While you read that correctly, actually, again, as I’ve said, even back then and now, the totality of evidence in the epidemiology studies does not support associations. In fact, the reason I was asked to serve on this expert panel was because I’d published in the epidemiology literature looking at dietary acrylamide and cancer risk. So that’s, in fact, the reason I was asked to serve as an expert panel member. Q. And, actually, this letter was written, I think we just agreed, on March 13th of 2008; right?A. Yes. Correct. Q. And in 1994, actually part of the available scientific evidence on acrylamide was that IARC had found acrylamide to be a probable carcinogen?MS. MATTHEWS JOHNSON: Objection, Your Honor. THE COURT: I think it’s time to move on. That question is stricken.

Fortunately for the plaintiff, judge cut off questioning because Mucci could have further explained differences between occupational/industrial exposures and human food intake of acrylamide as well as vastly different toxicokinetics of rodents and humans. Additionally, a Mucci co-authored 2009 review of epidemiological studies, including six studies co-authored by Mucci indicated acrylamide from food intake posed minimal or null risks for various cancer sites with risks for breast cancer among the lowest.

Possible reasons for the attempted undermining of Mucci: could include:

· Inadequate research into background of Mucci and/or acrylamide

· Intentional distraction away from an epidemiological cross examination which proved largely ineffective with Mucci during Roundup trial in California state court.

· Belief that these attempts would be effective narratives for relatively naive jury

· Inability of plaintiff’s team of lawyers to adapt from the free-wheeling mixture of document parsing/interpretation and scientific studies of previous California state trial to more constrained “scientific studies only” Phase I of federal court trial.

The reason may never be known because while the epidemiological studies are fundamental for general causation (association between NHL cancer group) and Roundup type products, the case also has various medical factors related to the specific causation of plaintiff’s NHL cancer which could play a predominate role.