[00:00:00] Speaker 00:
Good morning, your honor.

[00:00:02] Speaker 00:
May it please the court?

[00:00:04] Speaker 00:
Anne Saucer for Angelo Bologna.

[00:00:06] Speaker 00:
I will try to reserve four minutes for rebuttal, your honor.

[00:00:12] Speaker 00:
Very well.

[00:00:12] Speaker 00:
We respectfully request that this honorable court reverse the district court's dismissal of Mr. Bologna's non-Hodgkin's lymphoma case against Monsanto, the manufacturer of Roundup.

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I'd hope to get to three topics today.

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Number one, the district court abused its discretion

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by ignoring the most recent study cited in Dr. Zhang's expert report.

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Number two, the other study, mutation research, is not junk science.

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Finally, number three, the district court abused its discretion by not following the standards this court has promulgated in multiple cases with regard to the admissibility of expert testimony on causation in toxic exposure cases.

[00:00:55] Speaker 03:
Let me ask you this.

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I'm sure you're well prepared for all of this.

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As you know, the district judge in this case has had it for I think 10 years.

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Has had lots and lots and lots of testimony, lots and lots of analyses requiring a Daubert analysis.

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As I look at what the district court did here, it seemed to touch on

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the various Daubert criteria.

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You don't agree with the judge's interpretation of those criteria.

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But for example, in inciting one of the case, I forget which one it was, number 70 or something, he said that the doctor had basically cut parts of it out in the analysis.

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I don't know whether that's right, but that was, if I recall correctly, the analysis.

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And that allowed him to say, this is not apples and apples, it's apples and oranges.

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So what I'd like you to answer for me is this, under Dalbert,

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I understand the Supreme Court to have said that essentially the district judge has almost a holistic ability to analyze as the gatekeeper what expert testimony goes in.

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There's no question that he, in this case, noted that this was peer reviewed.

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He said that.

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He noticed that there was analysis of various kinds.

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He also said that it was

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kind of late, it was 2019.

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In short, he gave reasons for why he didn't think the Daubert analysis was adequate here.

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What am I missing?

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So, with regard to the last point first, the criticism about the timing of 2019 goes to my first point.

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Okay.

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Dr. Tseng's testimony was so up to date in this case that her chemist fear paper

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a 2023 paper was still in galleys.

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She submitted and attached and incorporated it by reference in her expert report.

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That paper was wholly ignored by the district court except for a footnote that selectively quotes it but omits the operative language.

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So that footnote in the district court opinion says this is not a causation opinion but quotes, actually misquotes, add words that aren't there,

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to the Chemisphere paper overlooking what the abstract says and what the paper repeatedly says about causation.

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In that paper, the Chemisphere paper, the abstract clearly says, the International Agency for Research on Cancer found the active ingredient in Roundup to be a probable human carcinogen based on mechanism, mechanistic criteria.

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And then it says, we have, we,

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Dr. Zhang and her six fellow scientists who authored that paper have looked at the emerging evidence on key characteristics of how a human cell turns into a cancer cell.

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And we found further evidence supporting the IARC's general causation opinion.

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But did not say, if I recall correctly, we conclude that this was a cause of what the plaintiff was asking.

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Is that right?

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Okay, so the evidence... In other words, you did talk about how conceptually, scientifically, it could be a cause, but didn't say this was the cause, right?

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So that's not the conclusion, but it's in the abstract.

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So the abstract clearly says that it uses the words classified as a probable human carcinogen.

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And neither Monsanto nor the district court has explained why that language is any different from a general causation

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Opinion they've just ignored that language isn't it just citing to what the UN body Actually, it's not a conclusion in itself No, your honor it goes on to say this is what the UN concluded and then it goes on to say We find strong evidence in support of that conclusion The okay clear evidence the glyphosate interacts with receptors it says later in here that

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our findings strengthen the mechanistic evidence that glyphosate is a probable human carcinogen.

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So this is right here, it's in the record, ER352, our findings strengthening the mechanistic evidence that glyphosate is a probable human carcinogen.

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So the... Okay, that's all true, but I mean, going back to...

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even back in the 50s about artificial sweeteners and the like.

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All kinds of things like that, but there was never anything that said this causes cancer in this person.

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I think that's what the judge was struggling with here.

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There's no connection.

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You've got a UN finding, you've got science finding, but nobody says this is the causation.

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Why would that not be relevant to the district judge's determination?

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This is a general causation opinion, so it was not intended to be, there was another expert that was going to speak to specific causation with regard to this plaintiff.

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This court has never required a study to say that there is causation in those exact words in the four corners of the study.

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So the Messick case decided by this honorable court, 747F3, 1198-99.

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This honorable court accepted a position paper and it was an association of like oral surgeons and the position paper said I respect that but but the reality is what we have to look at is a Judge that had this case for 10 years Seen all kinds of things heard all kinds of things and he he has to decide what goes to the jury You've got these statements

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Very learned people, heavily science-oriented, but he wants to know what should go to the jury.

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And he's looking for something to directly tie it here.

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So what's the matter under a Daubert analysis where it's holistic as a gatekeeper in effect?

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What's wrong with what he did here?

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What's wrong with what he did?

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So there are more than one thing wrong, but going back to mutation research.

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What's wrong with what he did is he completely ignored this paper other than a footnote that does not accurately cite mutation research.

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It's in the record beginning at ER 352.

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It's one of two papers that Dr. Zhang incorporated by reference into her expert report.

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And Monsanto's only answer to this is we get a pass for misstating in our motion that we won that this was not the paper that was relied on.

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And then they say ignore it because it's not an epidemiological study.

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It's a mechanistic study saying over and over and over again that there is strong evidence that glyphosate mechanically at the cellular level turns normal cells into cancer cells.

[00:08:16] Speaker 02:
In the Kennedy case... Can I ask, do you agree that, you know, the part cited by the district court in footnote five, do you agree that that does not show a causation, an opinion about causation?

[00:08:31] Speaker 00:
On note five?

[00:08:32] Speaker 02:
Yes, footnote five, which quotes from the conclusion of that mechanistic paper.

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I think that that language, which only looks at the conclusion and doesn't look to the abstract, is I don't think that it can be read like that, ignoring every single other thing that's stated previously in the paper.

[00:08:52] Speaker 02:
Well, I mean, it is the conclusion of the whole opinion.

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It seems reasonable to say, let's look at what the conclusion is.

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And it doesn't quite get up there.

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I mean, sometimes the Supreme Court decisions, the abstracts don't govern.

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I just wonder if that's the same way with these.

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It's in the record here that the scientist wrote the abstract, at least that's in the record with regard to mutation.

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May I talk?

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Is it reasonable then that the abstract's conclusion doesn't meet the paper's conclusion?

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Isn't that problematic in itself?

[00:09:26] Speaker 00:
I don't think it's problematic because I think this conclusion is written for scientists, it's not written for lawyers, and it may not have

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the word causation in it, but the word probable carcinogen, which is the general causation opinion, is previously in the study more than once.

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It's not just in the abstract, it's on the second page.

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Everything in Chemisphere has been ignored and that's an abuse of discretion pursuant to Kennedy and Alusu and Hardiman.

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Let me

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May I say what the entirety of this ignored paper says?

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It says there is strong evidence of Roundup's genotoxicity, which mechanistically causes cancer.

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There is strong evidence that Roundup induces oxidative stress, which mechanistically causes cancer.

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There is strong evidence that Roundup causes chronic inflammation, which mechanistically causes cancer.

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There is strong evidence that Roundup is an endocrine disruptor.

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which mechanistically causes cancer.

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There's some evidence that Roundup is electrophilic, which mechanistically causes cancer.

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There's some evidence that Roundup causes genomic instability, which mechanistically causes cancer.

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And I might have left one off the list, but what this says is that there are 10 emerging characteristics, key characteristics for how a human cell that's a normal cell becomes a cancer cell.

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And Roundup is 7 to 3.

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for the evidence showing that it causes cancer.

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If I may speak to the Alusu case, the Kennedy case, and the Hardeman case, and why those decisions show that ignoring all of this was an abusive discretion.

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What happened in Kennedy was there was a plaintiff's expert who had

[00:11:01] Speaker 00:
peer review, public literature, and the district court refused to consider any of it because it did not, the plaintiff's lawyer did not, the plaintiff's expert did not have an epidemiological study that with the four corners of the epidemiological study proved causation.

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And this honorable court said it was an abuse of discretion because there was other evidence in the public literature that needed to be considered.

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And in Olusu, this honorable court in 2022 cited Kennedy

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and followed it.

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So it is not proper to say.

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Monsanto's only argument for ignoring this, what they say, is that it's not an epidemiological study.

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But this court has said repeatedly that the court cannot put blinders on to all of the other evidence, including strong mechanistic evidence, that something does in fact cause the plainest condition simply by obsessing over

[00:12:00] Speaker 00:
the words causation in an epidemiological study.

[00:12:03] Speaker 03:
Do you want to save any of your time?

[00:12:04] Speaker 03:
It's entirely up to you.

[00:12:04] Speaker 00:
I'm sorry.

[00:12:05] Speaker 00:
I will save my time.

[00:12:06] Speaker 00:
I apologize.

[00:12:06] Speaker 00:
No, it's up to you.

[00:12:08] Speaker 03:
It's your time.

[00:12:09] Speaker 00:
Thank you, Your Honor.

[00:12:10] Speaker 03:
Very well.

[00:12:12] Speaker 03:
You say Otten, is that correct?

[00:12:17] Speaker 04:
Good morning, Your Honors, may it please the Court.

[00:12:20] Speaker 04:
Daniel Otten on behalf of Appellee Monsanto Company.

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Council spent most of her time talking about the 2023 mechanistic and animal

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So I'm going to start with a promise that I am going to get to that.

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And I'm going to explain that the district court didn't ignore it and that doesn't state a general causation opinion.

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But if your honors would permit, I'd actually like to start with what is the heart of the district court's opinion.

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And that is that Dr. Zhang's other study that was disclosed as part of her opinion was not a reliable study and was not a reliable treatment of the epidemiology data, the human data.

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And I'll say at the outset, I think your honor made a very good point.

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Judge Chabria, the district court judge, has been acting as a gatekeeper in this litigation for just about 10 years.

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I would submit that he did in this case exactly what Rule 702 requires.

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He held plaintiffs to their burden to prove that Dr. Zhang's opinions were reliable.

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and would be helpful to the jury, and he found that there were multiple ways in which they didn't meet that burden.

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Let me ask you this.

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Obviously, Daubert's the key to this whole thing.

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It appears that Chabria, if you will, touched on each of the elements involved, didn't ignore them.

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There's a disagreement about what they meant

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There's a disagreement about the peer review.

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There was what got cut out, what not, the ombrocetti, whatever.

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But when we look at Dalbert, the district court has a great deal of discretion, doesn't he, in determining whether, in this case, his opinion, looking at the facts

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as presented, even though they're scientific, it's not enough to get it to the jury.

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That's where the discretion comes in.

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Is that correct?

[00:14:10] Speaker 04:
I think that's right, Your Honor, and I think the foundational Rule 702 cases are clear that the factors that are articulated in Daubert and plaintiffs have picked out and focused on two of them, those are non-exhaustive discretionary factors.

[00:14:25] Speaker 04:
The foundational cases say that.

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In this circuit, Daubert II said that establishing

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For example, peer review and formation prior to litigation, quote, would not, of course, be conclusive.

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And the Supreme Court in its Daubert decision said peer review publication, quote, will be irrelevant, although not dispositive consideration.

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And here, to your Honor's point, the Court considered both of those factors.

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It considered the fact that Dr. Zhang published her paper in the literature and that that happened prior to litigation and discussed those factors.

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It gave them some weight.

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but it determined that there were other factors weighing against the reliability of that study and her opinions, that's not an abuse of discretion.

[00:15:08] Speaker 04:
That's applying the correct legal standard.

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It's exactly what Rule 702 and especially Rule 702D require the court to do as a gatekeeper.

[00:15:18] Speaker 01:
And on this issue... Do you think, counsel, that those two factors are the primary criteria?

[00:15:24] Speaker 04:
I know that there are some cases that use that kind of language.

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What I would say is that the cases are very clear that they are non-exhaustive

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and discretionary, I believe, in the Kumo-Tire case, the Supreme Court said that the district court has great leeway in deciding what factors are or are not relevant to assessing reliability in a particular case.

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So I don't think, I know the plaintiff cite a few quotes here and there describing them that way.

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I don't think that goes very far in terms of characterizing them.

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And turning to the district court's analysis or assessment of the reliability of Dr. Zhang's 2019 meta-analysis, I think it's critically important context

[00:16:01] Speaker 04:
to keep in mind that Dr. Zhang didn't provide a traditional expert report in this case.

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Instead, they provided a disclosure that said these two studies, that 2019 study and then the 2023 study, those are her report.

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They set out her entire set of opinions and the basis for them.

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And that's the context in which the district court had to assess that 2019 study.

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The question was not just, is this a study that would be fit for publication in a journal somewhere?

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The question was,

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Is this a reliable expert opinion on general causation to state a general causation opinion in this case?

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That's the context in which it assessed it and determined it wasn't reliable.

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And the core reliability issue with that study, Your Honors, is that Dr. Zhang and the study claim that it is an analysis of individuals with high exposure to glyphosate.

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That was her hypothesis and that's what the conclusion of the study says.

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But when you look at how she used the data, and your honor alluded to this earlier, it wasn't actually an assessment of individuals with high exposure.

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And I want to explain that a little bit.

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And I know it's a little complicated, especially for those who aren't steeped in this litigation.

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But Dr. Zhang used six studies in her meta-analysis.

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Half of those studies, so three of the six, did not break out their participants by exposure level.

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All they did was ask,

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Have you ever been exposed to glyphosate?

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So for those three studies, we don't know whether they've been exposed for one day or 100 days or 1,000 days.

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All we know is that they've ever been exposed.

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The way that Dr. John carried out her analysis, she said the highest exposure group for those three studies is the whole study.

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So she pulled in all of the data.

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from those studies where we don't know the exposure level.

[00:17:53] Speaker 04:
There are a couple of problems with that, significant problems.

[00:17:56] Speaker 01:
One is... Do you mind if I interrupt to ask you a broader question?

[00:18:01] Speaker 01:
I don't mind at all.

[00:18:03] Speaker 01:
I think these are arguments the other side would say are more persuasive for the jury.

[00:18:09] Speaker 01:
We're here primarily about admissibility.

[00:18:14] Speaker 01:
You know, it's a recurring theme in the law that district courts are given discretion to do certain things, but courts of appeals try to set some guardrails up.

[00:18:22] Speaker 01:
We had a case yesterday about when is something rare and exceptional, which could be taken to give the district court a lot of discretion, but the public courts have also tried to set up some guardrails to limit that.

[00:18:34] Speaker 01:
And so one of the guardrails that

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this court's precedents call out as peer review.

[00:18:38] Speaker 01:
The district court below distinguished between editorial peer review and true peer review.

[00:18:45] Speaker 01:
Do you support that distinction and do you think that has some rooting in this court's precedent?

[00:18:51] Speaker 01:
And if you could just speak more broadly to, you know, is that the sort of analysis that you think an appellate court should be doing in getting in, you might call it micromanaging,

[00:19:04] Speaker 01:
Do you support us putting those guard, you know, carrying on those little more fine-grained review of these decisions as a matter of law as opposed to deferring?

[00:19:17] Speaker 04:
I appreciate the question, Your Honor.

[00:19:18] Speaker 04:
Let me start with briefly with the editorial versus true peer review point and then I'll address the broader point.

[00:19:24] Speaker 04:
On the question of true peer review versus publication peer review, that wasn't the basis for the district court's decision.

[00:19:33] Speaker 04:
That reference to quote unquote true peer review is in a parenthetical near the end of the order.

[00:19:39] Speaker 04:
All the court was getting at is publication in a study is one thing.

[00:19:44] Speaker 04:
It is a factor that should be assessed when considering reliability.

[00:19:48] Speaker 04:
The reaction of the scientific community is another factor that should be assessed when considering reliability.

[00:19:55] Speaker 04:
And here the district court assessed both.

[00:19:58] Speaker 04:
There have been people who have been very critical of Dr. Zhang's paper since it's been published.

[00:20:01] Speaker 04:
But that's not the basis on which it determined that it was unreliable.

[00:20:05] Speaker 04:
And so I don't think that that is a key consideration.

[00:20:08] Speaker 01:
You don't think we need to adopt that distinction here?

[00:20:10] Speaker 04:
I don't think so, Your Honor, because that wasn't the basis for the district court's decision.

[00:20:14] Speaker 04:
Now, to address the broader point, which is a point well taken, and the point I made at the outset about the context of Dr. Zhang's paper being disclosed as her report in this case is important context.

[00:20:31] Speaker 04:
Given that disclosure, it's not only within the court's discretion.

[00:20:36] Speaker 04:
Rule 702D actually requires that the court assess whether the analysis set forth in that paper is a reliable application.

[00:20:47] Speaker 04:
For the same reason that if an expert served a traditional report and said, I've applied the Bradford Hill analysis, it wouldn't be enough for the court to say, well, that's a reliable methodology and go no further.

[00:20:58] Speaker 04:
Under 702D, it has to.

[00:21:00] Speaker 04:
It would have to assess, well, did they actually conduct a reliable Radford Hill analysis?

[00:21:08] Speaker 04:
Same is true here.

[00:21:08] Speaker 04:
Dr. Zhang has said this epidemiology meta-analysis is my opinion on the epidemiology literature.

[00:21:16] Speaker 03:
And that's where your point about the exposure gets in, whether a little bit of exposure or a lot of exposure.

[00:21:23] Speaker 03:
The district court can make that analysis himself, whether or not the peers did that, right?

[00:21:29] Speaker 04:
Well, and that it's not an issue that just goes to wait or that should go to the jury.

[00:21:34] Speaker 04:
It's a methodology issue, because what Dr. Zhang is claiming she did does not match up to her actual use of the data.

[00:21:43] Speaker 04:
That's a 702D issue.

[00:21:45] Speaker 04:
That's a reliability issue.

[00:21:47] Speaker 04:
And to go back to my point about that, she pulled in from three studies all of the data where we truly don't know what the exposure level was.

[00:21:56] Speaker 04:
And stepping back, to be clear,

[00:21:59] Speaker 04:
That means that for the majority of the cases in her meta-analysis, we do not know whether they were exposed to glyphosate for one day, 100 days, or 1,000 days.

[00:22:10] Speaker 04:
But Dr. Zhang nonetheless says, this lets me conclude that individuals with high exposure have an increased risk.

[00:22:19] Speaker 04:
And that's the reliability issue, that there's no reason to think that the majority of the cases in her analysis actually had high exposure.

[00:22:27] Speaker 04:
We just don't know.

[00:22:28] Speaker 04:
And it's within the district court's discretion to conclude that an opinion like that, where the use of the data does not match up to what she says the conclusion is, what she says she set out to do, is unreliable.

[00:22:42] Speaker 04:
Now, let me fulfill my promise to get back to the 2023 paper.

[00:22:47] Speaker 04:
The first point is, well, let me start with, it's undisputed that that paper is not a treatment of the epidemiology.

[00:22:55] Speaker 04:
Literature, it is an assessment of data and animal

[00:22:59] Speaker 04:
in cell studies.

[00:23:00] Speaker 04:
And a panel of this circuit in the Hardiman case made clear that at least in the context of this litigation, a general causation opinion has to be based on the epidemiology data.

[00:23:13] Speaker 04:
Hardiman said, this is Hardiman from 2021 at 952, quote, to be admissible testimony, the experts must have reliably based their general causation opinions on epidemiological evidence

[00:23:28] Speaker 04:
showing a connection between glyphosate and cancer.

[00:23:31] Speaker 02:
Why is that the case?

[00:23:32] Speaker 02:
That doesn't make sense to me.

[00:23:33] Speaker 02:
That seems like a jury question.

[00:23:35] Speaker 04:
That's what the panel said in Hardeman.

[00:23:36] Speaker 04:
And the reason is that there's a large body of studies of exposure to glyphosate in humans.

[00:23:43] Speaker 04:
And so that is the best scientific evidence.

[00:23:45] Speaker 04:
And so you have to at least start with the conclusion that that evidence, the best evidence, shows a connection before you turn to animal and cell studies.

[00:23:55] Speaker 02:
That's not to say that those can't be... Why can't you use weak evidence to support it?

[00:23:59] Speaker 02:
That doesn't make sense to me.

[00:24:01] Speaker 04:
Respectfully, Your Honor, that is what the Court said in Hardeman, which I think is right, that where you have a strong, or a significant body of human studies, you can't say, well, that doesn't show a connection, but I'm going to turn to weaker cell studies, and somehow that shows the general causation opinion.

[00:24:18] Speaker 04:
That's consistent with the gatekeeping that the Court has

[00:24:21] Speaker 04:
been doing for years in this litigation.

[00:24:23] Speaker 04:
I think it's well supported.

[00:24:25] Speaker 02:
And it was, um, I mean, it could make the inference that if it causes cancer in animals, it will cause cancer in humans, right?

[00:24:34] Speaker 04:
You, I don't, you can't reliably make that leap where you have a large body of human studies and if they're inconsistent with that conclusion.

[00:24:41] Speaker 04:
And so council said that the court ignored the 2023 study.

[00:24:47] Speaker 04:
That's just demonstrably not true.

[00:24:49] Speaker 04:
It cited it.

[00:24:49] Speaker 04:
It discussed it.

[00:24:50] Speaker 04:
It's in its order.

[00:24:51] Speaker 04:
And its point was, consistent with that quote that I just read from Hardiman, a general causation opinion in this litigation has to be based, first and foremost, on the human studies.

[00:25:03] Speaker 04:
That publication.

[00:25:03] Speaker 02:
But that's not the reason why the district court excluded it.

[00:25:05] Speaker 02:
It said that there was just no causation.

[00:25:07] Speaker 02:
And your friend on the other side is saying, if you read the abstract, there is some causation statements in the report.

[00:25:13] Speaker 02:
So what's your response to that?

[00:25:14] Speaker 02:
Yeah.

[00:25:14] Speaker 04:
Let me get to that.

[00:25:14] Speaker 04:
And the only thing to wrap up.

[00:25:16] Speaker 04:
You only have two minutes.

[00:25:16] Speaker 04:
Why don't you get to it now?

[00:25:18] Speaker 04:
Sure.

[00:25:18] Speaker 04:
I'll do it now.

[00:25:18] Speaker 04:
The phrase that she points to is the phrase probable human carcinogen.

[00:25:23] Speaker 04:
They say it in their brief.

[00:25:24] Speaker 04:
She said it just now.

[00:25:26] Speaker 04:
I know that that might sound to the layperson like a causation opinion.

[00:25:29] Speaker 04:
It's not.

[00:25:31] Speaker 04:
And here's why.

[00:25:32] Speaker 04:
In a panel, in the Hardeman panel explained why it's not, and so did the district court in the decision that was affirmed.

[00:25:37] Speaker 04:
That probable human carcinogen is a phrase that come in a classification that is used by IARC.

[00:25:43] Speaker 04:
And that is the body of the World Health Organization, as Your Honor said.

[00:25:46] Speaker 04:
That's the context in which Dr. Zhang uses it in that paper.

[00:25:51] Speaker 04:
The way that IHRC makes that classification is they look at whether an exposure to a substance at any level, including levels that humans could never experience, could potentially cause cancer.

[00:26:02] Speaker 04:
It's called a hazard assessment.

[00:26:04] Speaker 04:
That's what that classification represents.

[00:26:07] Speaker 04:
That is not the general causation threshold and inquiry in this case.

[00:26:12] Speaker 04:
And in Hardiman, the court framed it as,

[00:26:14] Speaker 04:
that the experts need to show that glyphosate can cause NHL at exposure levels humans can experience.

[00:26:21] Speaker 04:
And for that reason, the district court, when discussing the IARC hazard classification, it said in the decision that was affirmed in Hardeman, a hazard assessment as IARC and other public health bodies define that inquiry is not what the jury needs to conduct when deciding whether glyphosate actually causes NHL

[00:26:43] Speaker 04:
in people at past or current exposure levels.

[00:26:46] Speaker 04:
The panel affirming that decision similarly said, quote, that the hazard determination, quote, did not include a risk assessment, gauging carcinogenic effects from real world exposure.

[00:26:57] Speaker 04:
And so counsel has been very clear that their view is probable human carcinogen is a general causation opinion.

[00:27:04] Speaker 04:
That's not the case.

[00:27:06] Speaker 04:
And the decisions, the published decisions of this circuit have addressed that and said it's not the case.

[00:27:11] Speaker 04:
And so I've

[00:27:12] Speaker 04:
I have 10 seconds left.

[00:27:14] Speaker 04:
I'll happily give your honors that time back.

[00:27:16] Speaker 04:
Thank you.

[00:27:16] Speaker 04:
If you don't have any further questions.

[00:27:17] Speaker 03:
I think not.

[00:27:18] Speaker 03:
Thank you very much.

[00:27:19] Speaker 03:
Thank you, your honors.

[00:27:20] Speaker 03:
All right.

[00:27:21] Speaker 03:
Ms.

[00:27:21] Speaker 03:
Souser, you have some rebuttal time.

[00:27:30] Speaker 00:
The point is not just that probable human carcinogen was said, but the point is that the entire study explains

[00:27:39] Speaker 00:
why it is that those findings are further supported.

[00:27:43] Speaker 00:
But if I may pivot to mutation research, which was called junk science, all of the criticisms, beyond the personal insults of the doctor, all of these criticisms flow from two facts.

[00:27:58] Speaker 00:
Number one, that the a priori hypothesis was applied.

[00:28:02] Speaker 00:
We filed in the district court record eight studies applying that hypothesis.

[00:28:07] Speaker 00:
We, for purposes of this appeal, found over a dozen more.

[00:28:11] Speaker 00:
The A priori hypothesis is Bradford Hill.

[00:28:14] Speaker 00:
It is a recognized scientific methodology that has been applied again and again and again.

[00:28:21] Speaker 00:
This complaint that, well, we don't know, she set out to say high exposures, but we don't really know, that goes to the fact that these six studies were used.

[00:28:33] Speaker 00:
Both, Santo has very heavily relied on the EPA Miller opinion.

[00:28:39] Speaker 00:
Miller agreed the same six studies were the appropriate studies.

[00:28:44] Speaker 00:
Dr. Zhang and her four co-scientists writing mutation research could not have changed what those study authors decided to do in terms of how they stratified the exposure data.

[00:28:56] Speaker 00:
So they had to deal with the limits.

[00:29:00] Speaker 00:
Some of those studies stratified, some of them did not.

[00:29:03] Speaker 00:
So this complaint that it's supposed to get you the highest concentration, some of those studies did not break out the numbers.

[00:29:11] Speaker 00:
And there is a complaint at length that in length in the briefing looking at, well, here's a number from, I think it's McDuffie or Erickson, and it's higher exposure than the second quadrant number from Andriotti.

[00:29:26] Speaker 00:
All of that is simply a complaint

[00:29:29] Speaker 00:
that the a priori hypothesis was applied to the same six studies that EPA's Miller said were appropriate to study on this issue.

[00:29:43] Speaker 01:
that criticism may or may not have merit.

[00:29:45] Speaker 01:
We're here on abuse of discretion review, and that's a very in the weeds criticism, and we'll engage with it.

[00:29:51] Speaker 01:
What do you think is your highest level of generality criticism of the way the district court abuses discretion, as opposed to the in the weeds level?

[00:30:00] Speaker 00:
The district court abuses discretion because, as your honor noted, this court has promulgated two significant factors on the controlling the admissibility of

[00:30:12] Speaker 00:
expert causation evidence, and both of those factors are met here.

[00:30:16] Speaker 00:
That Dr. Zhang was not involved in 2019 in any sort of litigation of plaintiffs, number one, and number two.

[00:30:26] Speaker 00:
Her, this, not only her paper was peer reviewed, but as I said, the a priori hypothesis, and it's the proper application of the a priori hypothesis that

[00:30:37] Speaker 00:
has generated all of this criticism.

[00:30:39] Speaker 00:
There are simply limits to applying the A priori hypothesis.

[00:30:42] Speaker 00:
She and her four scientists looked at the work of other studies from around the world, and they had no ability to go and control the fact that some of them categorized exposures differently, and some of them did not.

[00:30:56] Speaker 00:
And so it's abusive discretion to ignore the two primary

[00:31:01] Speaker 00:
those two primary factors promulgated by this honorable court.

[00:31:05] Speaker 00:
And there is a footnote in Daubert 2 that says if you want to rebut, overcome the deference we the Ninth Circuit give to these two primary factors, then you, the defendant, can bring in your own evidence.

[00:31:18] Speaker 00:
And they did not do that at this hearing.

[00:31:20] Speaker 00:
They did not come forward with anyone to say there was no peer review.

[00:31:24] Speaker 00:
A lot of the statements that are made in the brief are simply

[00:31:27] Speaker 00:
opinions made by Monsanto that they did not prove up in this case.

[00:31:32] Speaker 00:
Okay.

[00:31:33] Speaker 03:
Your time is up.

[00:31:34] Speaker 03:
Let me ask my colleagues whether they have additional questions.

[00:31:36] Speaker 03:
Thanks to both counsel for your learned argument.

[00:31:39] Speaker 03:
We appreciate it.

[00:31:39] Speaker 03:
This is a significant case.

[00:31:42] Speaker 03:
The case just argued is submitted and the court stands adjourned for the day.