[00:00:01] Speaker 00: Case 14-5226. [00:00:04] Speaker 00: Lori Lern, Inc. [00:00:06] Speaker 00: et al. [00:00:07] Speaker 00: The United States Food and Drug Administration et al. [00:00:10] Speaker 00: Appellants. [00:00:10] Speaker 00: Mr. Stern for the appellants. [00:00:12] Speaker 00: Mr. Cooper for the appellees. [00:00:35] Speaker 02: Before we start, I know that there are a lot of sealed materials in this case, and you're not sure if you're going to need to refer to them. [00:00:45] Speaker 02: If you do feel like you need to at any point on your owner in response to questions, please let me know, and we're prepared to clear the courtroom. [00:00:55] Speaker 05: May it please the court, the FDA established the Tobacco Advisory Committee pursuant to the directive of the Tobacco Control Act of 2010. [00:01:07] Speaker 05: The Tobacco Control Act was charged with various responsibilities as principally relevant here. [00:01:16] Speaker 05: They included the creation of [00:01:18] Speaker 05: on menthol in cigarettes and also a report on dissolvables and the report on menthol was due to be submitted within a year of the creation of the committee and that is indeed what happened. [00:01:38] Speaker 05: plaintiffs in this case brought various claims in district court. [00:01:43] Speaker 05: They asserted claims under the Federal Advisory Committee Act, and also they asserted that the three of the members should have been recused because they had conflicts of interest within the meaning of the federal conflict of interest laws. [00:02:01] Speaker 05: And the district court accepted that proposition and found that two of the members had actual conflicts and a third had appearance conflicts. [00:02:12] Speaker 05: And on that basis, the district court enjoined FDA from using in any way the mental health report, and its order also precludes the three members at issue from performing any further tasks on the advisory committee. [00:02:30] Speaker 05: We think that the court's order is wrong for a whole series of reasons, starting with standing on the disability, on the merits, and finally in the nature of the relief. [00:02:47] Speaker 06: Council, you overwhelmingly stress standing. [00:02:53] Speaker 06: But I don't think you mentioned the problem of rightness. [00:02:56] Speaker 06: I'm wondering whether the specific arguments you make don't fit better as a rightness defense, because they primarily sound in the proposition not so much that these plaintiffs aren't injured, but that they [00:03:16] Speaker 06: their nature of their injury is unclear at this stage, may never eventuate, and so forth, all of which sound like rightless arguments. [00:03:27] Speaker 05: Well, I agree that it's related to rightness and rightness principles. [00:03:32] Speaker 05: I do think it is a standing problem, but it is certainly the case that if, that there are a whole series of ifs and the, what the principle, I mean plaintiffs complain of various injuries, but the principal injury that they complain of [00:03:51] Speaker 05: is that FDA may rely on the menthol report in some future rulemaking. [00:04:00] Speaker 05: And we think that if FDA issues a report, then we'll know, or excuse me, issues a rule. [00:04:09] Speaker 05: It's going to have to be based on FDA's own independent scientific research that's required by the statute. [00:04:15] Speaker 05: It's going to have to go. [00:04:17] Speaker 06: I mean, I understand your understanding argument there, too. [00:04:21] Speaker 06: You're very much invoking a right, something that sounds a right, because you're saying we'll know when and if the agency issues a rule, the extent to which it was influenced or may have been influenced by the alleged wrong here. [00:04:39] Speaker 05: That's right. [00:04:41] Speaker 05: I do think that all arguments in the event of a final rule that plaintiffs are agreed by, they'll be able to challenge every aspect and no doubt will of the rulemaking and they'll be able to say that, you know, sort of going back to the initiation of this, [00:05:01] Speaker 05: sort of members who were leading, who had been testified repeatedly on behalf of plaintiffs in suits against the tobacco industry, participated in the creation of the report, and that list will be many other claims that are made, too. [00:05:19] Speaker 05: And all of those can be aired in the event that there is a final rule. [00:05:24] Speaker 05: So in that case, I do think that I'm not sure that I put the ripeness label on it, but I agree, I think, [00:05:31] Speaker 05: with the point sort of underlying your comment. [00:05:37] Speaker 02: You've argued imminence, certainly, as a standing argument, right? [00:05:41] Speaker 02: There's no imminent injury. [00:05:42] Speaker 02: To them, you've argued that. [00:05:45] Speaker 02: You have argued that. [00:05:45] Speaker 05: Yeah, there's certainly, we don't think that there's imminent injury. [00:05:51] Speaker 05: We don't think that, for that matter, for a lot of these injuries, we don't think that there's regressibility either. [00:05:58] Speaker 01: What about the district court's determination that members of the committee who already have engagements to do future testimony against the plaintiffs here creates a conflict that's current and real? [00:06:19] Speaker 05: something I mean there certainly can't be a rule that says that you're harmed because a plaintiff who participated in because a with somebody an expert who participated in the creation of the report is going to take some future is going to present testimony is already [00:06:42] Speaker 01: under agreement to present that testimony against the very industry that plaintiffs participate in? [00:06:52] Speaker 05: Yeah, I mean, I'm not sure to what extent. [00:06:55] Speaker 05: I mean, I have to look back to see to what extent there really are such agreements that are in place, but there is no indication. [00:07:02] Speaker 05: I mean, there's been a while since [00:07:07] Speaker 05: after the report issued, what we have is nothing to support the claim of any harm that's been inflicted by any testimony that's in any way related to sort of the Menful report. [00:07:23] Speaker 01: Aren't they claiming that at least one of the members in fact referred to the menthol report? [00:07:29] Speaker 05: Yeah, what the plaintiff said, or excuse me, what I believe it's Dr. Hanningfield said in that part is he was asked, and it's not in, I think it's sort of in, it's part of a pretrial deposition. [00:07:45] Speaker 05: It's not part of testimony, if I'm remembering right. [00:07:48] Speaker 05: And he was asked, I think, by opposing counsel, [00:07:52] Speaker 05: would you, you know, are you going to say anything about menthol?" [00:07:57] Speaker 05: And he says, well, what I would say about menthol is what I've said when I've testified before. [00:08:02] Speaker 05: And then he notes that the statement that the report of the advisory committee [00:08:10] Speaker 05: says more or less the same kinds of things that he said before. [00:08:14] Speaker 02: But isn't that exactly, I mean that's the problem. [00:08:16] Speaker 02: The injure they're going to say is these folks come serve on this committee knowing that they have 900 plus [00:08:24] Speaker 02: contracts for expert testimony lined out in front of them, all of which will be worthless if they produce a report that says the opposite of what they've been saying for the last 10, 20 years. [00:08:35] Speaker 02: And now instead, they get to go into those courtrooms and say, here's my testimony. [00:08:40] Speaker 02: And guess what? [00:08:41] Speaker 02: This blue ribbon panel from the FDA agrees with me. [00:08:46] Speaker 02: And suddenly, they've got corroboration and credibility. [00:08:49] Speaker 02: What about that as an injury? [00:08:51] Speaker 05: First of all, I don't see, I mean, there is no, there's no injury of that sort that's actually, I think, been claimed here, but. [00:09:00] Speaker 02: So my testimony is consistent with the Menthol report. [00:09:02] Speaker 05: Well, I mean, this was the testimony, I mean, the Congress wanted to have people, this is the Tobacco Control Act, the Congress wanted to have the people who were the leading experts in the field be on this committee. [00:09:19] Speaker 05: those people by nature or the fact that they are experts, one of the many things that they do, and it's not that they have a profession of being like expert witnesses, but one of the things that they do is they testify at trials. [00:09:35] Speaker 05: So if one of the witnesses testifies at a trial in a way that's consistent with everything that he's said before, [00:09:44] Speaker 05: I don't think that that doesn't amount to harm. [00:09:49] Speaker 05: I mean, the claim here is that somehow the report was stacked. [00:09:53] Speaker 05: And this is summary judgment. [00:09:54] Speaker 05: It's not sort of a mere – it can't rest on a mere allegation. [00:09:58] Speaker 05: Plaintiffs have had countless documents. [00:10:00] Speaker 05: They've had all of the emails of the advisory committee. [00:10:05] Speaker 05: There's not a shred of evidence that an [00:10:07] Speaker 05: in any way this was stacked against them. [00:10:11] Speaker 05: I also think that as far as it goes, Dr. Henningfield wasn't even one of the drafters of the report. [00:10:19] Speaker 05: That's just sort of the solid. [00:10:22] Speaker 05: He was on the committee, but he was not one of the subcommittee that drafted the report. [00:10:28] Speaker 01: But presumably every member of the committee is important. [00:10:31] Speaker 01: I mean, that's why they're on the committee. [00:10:33] Speaker 01: And I think it's fair for us to presume that they had [00:10:37] Speaker 01: influence otherwise any minority of an advisory committee could be biased and there would be no harm and you're under your theory but there's no I mean again what we have is simply [00:10:54] Speaker 05: The focus of the trial on which Dr. Henningfield gave this testimony in deposition was about nicotine addiction. [00:11:06] Speaker 05: What Dr. Henningfield said, well, would you say anything about men's voices? [00:11:10] Speaker 05: Look, in a particular case, [00:11:12] Speaker 05: You know, in general, I can tell you that it's my view, which was the view of the advisory committee, but it's his long-standing view that menthol makes it harder to quit, but that in any given case, he says, [00:11:30] Speaker 05: important at the end, at the beginning stages in attracting people, making them addicted in the first place than it is at the quitting stage, and that he couldn't make a generalized statement about it to put apply. [00:11:46] Speaker 05: And that's all that he says. [00:11:48] Speaker 05: And the trial is not a trial about menthol. [00:11:51] Speaker 05: It's a trial about was this person [00:11:53] Speaker 02: one of the features of the trial was... If you're a trial attorney and you get to put your expert witness on, and I'm sure they have their expert witnesses, wouldn't you rather have an expert witness that you can then also tell the jury [00:12:09] Speaker 02: is was it was his his his judgments his opinions were concurred in by unanimously by this blue-ribbon commission and he was just a member he didn't even write it all those people who wrote it with all their expertise they agreed to that would be the case then if he was simply on the committee right I mean it's just [00:12:32] Speaker 05: I mean, there's such a broad sweeping view of what injury could be. [00:12:37] Speaker 05: I mean, that's not the kind of sort of direct causal substantial imminent injury that's been thought. [00:12:45] Speaker 05: The fact that somebody may say, wow, this person who's testifying has an extra credential. [00:12:50] Speaker 02: They've got 900 plus of these things lined up. [00:12:53] Speaker 02: That's not disputed. [00:12:54] Speaker 02: That's not speculative. [00:12:57] Speaker 05: I'm not I don't know that they have 900 things that under a contract Collectively, I think that's Back and look at that. [00:13:07] Speaker 05: I mean again, they're in the hundreds and hundreds. [00:13:10] Speaker 05: Okay, so they've got that It's not we then go off to have a series of menthol trials. [00:13:19] Speaker 05: I mean these are trials [00:13:20] Speaker 05: trials that are being brought by smokers are the same kinds of trials that these people testified in before. [00:13:26] Speaker 05: They're the very people that Congress wanted to have on the committee because these are the experts in their field and the fact that they're going to continue to testify and not even principally about menthol [00:13:40] Speaker 05: I mean, essentially what plaintiffs want is just a rule that says if you're somebody who is in the business of testifying against the tobacco industry, you're disqualified. [00:13:51] Speaker 01: Is there anyone in your view or category of person or type of person at a particular level of rightness that would have standing? [00:13:59] Speaker 01: I mean, I know you claim that there is no private right of action here, but assuming for the moment that there might be, where's the better standing candidate? [00:14:13] Speaker 05: It's hard for me in this case. [00:14:15] Speaker 05: I mean, I can mention that there would be, I mean, say, like in NRDC versus Pena, this court, just based on the allegations there, the court said, well, one of the predicates to establish you sort of set out, I mean, that had to do with a nuclear sort of reactor. [00:14:34] Speaker 05: And they sort of said, well, if you could establish that you live in this area that you might be exposed to increased environmental risk, [00:14:41] Speaker 05: That might be step one, and then the court cautioned, but by the way, the fact that this is going to go through notice and comment rulemaking may make it very difficult for you to establish. [00:14:52] Speaker 06: That's a standard federal rightless property. [00:14:55] Speaker 05: But the court characterized there to stand there. [00:14:57] Speaker 06: What we're talking about here is the impact in these cases, which are comparable perhaps, but certainly not standard federal regulatory rightless issues. [00:15:10] Speaker 05: Well, the court in NRTC did say that that was an issue of standing. [00:15:14] Speaker 05: I mean, that was the word that they used. [00:15:17] Speaker 05: They said that you may have difficulty in establishing standing when there's going to be a notice in common rulemaking. [00:15:24] Speaker 05: I do think that that's right. [00:15:26] Speaker 01: That does seem relevant to the claim that their harm because the menthol report makes it more likely that the agency will in fact regulate menthol because you know as you point out there's this intervening notice and comment rulemaking that would [00:15:42] Speaker 01: seemed to give them plenty of chance to put their perspective and to attack the report. [00:15:48] Speaker 01: So it's hard to say there's necessarily injury there, but we were focusing on some of the other injuries and it may be that your position is that there is nobody who has injured in those ways such that everything else being not an obstacle. [00:16:10] Speaker 05: too much about what could be a problem. [00:16:13] Speaker 05: I mean, we think of the things that we don't have here. [00:16:15] Speaker 05: We don't even have a lawsuit, allegations about a lawsuit the plaintiffs lost, let alone an allegation that plaintiffs lost a lawsuit because of the testimony of one of these three members. [00:16:27] Speaker 05: I mean, that would be what you'd normally think would be essential to the standing argument. [00:16:31] Speaker 02: So your point is an increase, I guess, some modicum of increase in litigation risk is not an article for injury. [00:16:38] Speaker 05: I think that's what you're saying, right? [00:16:41] Speaker 05: I mean, at this level of speculation, no, it's not an Article III injury. [00:16:46] Speaker 02: Even if in some other hypothetical case you actually knew that the consequence of the activity was going to make it harder to win the case that you have next week, is that an Article III injury, the difficulty in winning your case? [00:16:59] Speaker 05: You'd have to trace it back to the [00:17:02] Speaker 05: menthol report. [00:17:03] Speaker 05: I mean, you have to go both ways, but if somehow you could put it all together. [00:17:07] Speaker 02: You've got the menthol trial next week. [00:17:09] Speaker 02: It's about a menthol case, and this is hypothetical. [00:17:12] Speaker 02: As far as I can tell from this record, there's a menthol trial next week. [00:17:16] Speaker 02: And now this guy gets to, in addition to all his nice credentials, say, and by the way, the blue ribbon panel, they all agree with this view as well. [00:17:27] Speaker 05: I don't think so, but I'd agree that that's a harder case. [00:17:38] Speaker 05: I mean, again, all we're talking about is somebody who is taking part in a holy advisory document, and the fact that somebody, like, that he can then cite to that, you know, for what it's worth, and plaintiffs can, like, attack it, you know, in adversarial litigation. [00:18:01] Speaker 05: I don't think that that rises, but that's not even what we have here. [00:18:05] Speaker 05: We're steps yet away from that. [00:18:09] Speaker 05: And I think that it's telling that the only thing that plaintiffs want to include is the testimony that you referred to, Judge Pillard. [00:18:20] Speaker 02: On the, you make an argument in your brief that the conflict of interest rules don't create any protected interest in anybody, they're there to protect the government and the government only. [00:18:34] Speaker 02: But the Mississippi Valley case specifically referred to protecting the public [00:18:41] Speaker 02: as well, and it seems to me that, you know, that just looking around this world, the people that are often most hurt by corrupt government officials are the citizens and residents of the country that are having to live their lives under corrupt officials. [00:18:58] Speaker 02: So why aren't they correct in saying that, at least it's that argument, that the ethics rules create protected interests for the public as much as for the government? [00:19:11] Speaker 05: Well, I mean, Mississippi Valley, which cited, I think, Chemical Foundation, which says that the interest, that the rules are there to protect the government. [00:19:21] Speaker 05: As I recall, the holding in Mississippi Valley is that the government didn't, couldn't waive the conflict in its interest. [00:19:29] Speaker 05: And the statements about the general welfare, look, there's a direct [00:19:33] Speaker 05: link between, like in this case, I mean I know we often say that there is a direct link between the public welfare and what the government does, but there's certainly, the public has a very strong interest in not having its government be subject to [00:19:52] Speaker 05: employees or, in this case, advisory committee members. [00:19:57] Speaker 05: But all of these arguments that are being made by the plaintiffs do not distinguish in any meaningful way between employees and advisory committee members. [00:20:07] Speaker 05: And it's certainly true that the public has a strong interest in making sure that the government employees are dedicated to the service of the government and that they aren't using their position [00:20:21] Speaker 05: for their own financial gain, and that's what the conflicts laws do. [00:20:26] Speaker 05: But then the question is, okay, how do these laws then get enforced? [00:20:33] Speaker 05: And to date, we've done reasonably well without there being a private litigation [00:20:42] Speaker 05: arm to enforce the conflict laws. [00:20:47] Speaker 05: And I think the consequences of taking a different view would be fairly extraordinary. [00:20:54] Speaker 05: And the point is not that it's sort of a wrong position because it would open the floodgates. [00:21:01] Speaker 05: The fact that it would open the floodgates [00:21:07] Speaker 05: of what's wrong with this argument. [00:21:11] Speaker 05: And it's hard to know exactly which doctrinal box or boxes to put the problem into, whether it's an issue of enforcement discretion. [00:21:25] Speaker 02: Well, let's just assume that [00:21:31] Speaker 02: that these ethics rules are meant to protect the public as well as the government. [00:21:36] Speaker 02: It's all interconnected. [00:21:39] Speaker 02: They label that a procedural, a violation of the ethics rules of procedural injury. [00:21:46] Speaker 02: Would you, I know you wouldn't agree that they have a procedural injury here, but would you characterize that interest, whether you call it the government's interest or the public's interest, a procedural one or a substantive one? [00:21:57] Speaker 02: How do I know when something's a procedure versus a substance in this sense? [00:22:02] Speaker 05: I mean, as you know, we think that whether you characterize it as procedural or not doesn't affect this. [00:22:07] Speaker 05: I got that. [00:22:08] Speaker 05: I got that. [00:22:08] Speaker 02: I'm just trying to figure out how I know it's procedural. [00:22:10] Speaker 05: I don't fully understand why this would be procedural. [00:22:13] Speaker 05: I'm not sure what the procedure is. [00:22:15] Speaker 01: You went through the procedure. [00:22:16] Speaker 01: I guess there's no dispute. [00:22:17] Speaker 01: The waiver process, I think, is part of what they're aiming at, no? [00:22:20] Speaker 01: I mean, that there's a public process. [00:22:23] Speaker 05: Well, there was a, I mean, you can't fault the agency for [00:22:29] Speaker 05: not trying really hard. [00:22:32] Speaker 05: I mean agencies don't have to do anything like the kind of really detailed sort of examination and papering over that this agency did in this case. [00:22:48] Speaker 05: in the government for people to go to their ethics officer, say, I've got a potential conflict. [00:22:56] Speaker 05: Now if the officer may go, my opinion that there's no conflict, and he doesn't even have to write that down. [00:23:05] Speaker 05: And if the ethics officer thinks that there is a conflict but it's not substantial, then you can give a written certification and then under 208B that gives you a safe harbor or for advisory committees under 208C the ethics official can go [00:23:24] Speaker 05: Even if the conflict is substantial, I give you a waiver and you're protected. [00:23:29] Speaker 05: But that's the whole procedure. [00:23:32] Speaker 01: We've kept you long. [00:23:33] Speaker 01: I have just one last question about the merits that relates to the process that was undertaken here. [00:23:38] Speaker 01: I know there was an FDA opinion on the lack of a need to screen for the tobacco cessation products. [00:23:50] Speaker 01: And then there was screening. [00:23:53] Speaker 01: you know, conflict screening before the meetings, before the mental meetings, did they just not include consideration of cessation products or did they go ahead and include them even though they had an opinion that they didn't really need to go through? [00:24:10] Speaker 05: I think what they concluded was that they didn't need to, they wanted to know [00:24:18] Speaker 05: When I do my meeting by meeting, what are you going to be discussing? [00:24:23] Speaker 05: Like, am I going to have to revisit each time the issue of smoking cessation? [00:24:28] Speaker 05: And I think that what they had decided was, no, we don't need to do that. [00:24:34] Speaker 01: And so you think those meeting by meeting screenings did not look into that? [00:24:39] Speaker 05: I don't think. [00:24:41] Speaker 05: I don't think that, I mean, we don't have, I don't think we've got a record of exactly what, but I think that was the point, was that there was an extensive investigation by the agency into whether it thought it needed to do something, whether it needed to consider giving waivers or recusing people, as in one case, with respect to dissolvables, it did recuse somebody. [00:25:06] Speaker 02: All right, thank you. [00:25:08] Speaker 05: Thank you very much, Your Honor. [00:25:15] Speaker 04: May it please the court and Richard Cooper for Reynolds. [00:25:18] Speaker 04: I want to address first the Judge Williams question about ripeness. [00:25:22] Speaker 04: In the Wyoming outdoor council case, which is cited in our brief 165F3, at page 51, the court said, as the Supreme Court noted in Ohio forestry, quote, a person withstanding who was injured by a failure to comply with, bracket, some procedural requirement, close bracket, [00:25:41] Speaker 04: may complain of that failure at the time the failure takes place for the claim can never get riper. [00:25:47] Speaker 04: We've already suffered two injuries that already exist, independent of any rulemaking that may occur. [00:25:53] Speaker 02: Well, that point only goes to your procedural injury argument. [00:25:56] Speaker 02: Do you have any argument on ripeness as to your argument about skewing the menthol report and the impact on future testimony? [00:26:03] Speaker 04: Yes, that those injuries have already occurred. [00:26:07] Speaker 04: And if it's not right now, it never will be right. [00:26:09] Speaker 04: and therefore will be unremittable. [00:26:12] Speaker 04: The injuries involving access to our confidential information exist as we sit here and stand here today. [00:26:18] Speaker 02: How does a use injunction that you got protect you against that? [00:26:24] Speaker 02: It doesn't affect their testimony. [00:26:26] Speaker 04: It protects us only prospectively. [00:26:27] Speaker 04: Again, Dr. Samet was on the committee [00:26:30] Speaker 04: When the district court issued its opinion, he remained on the committee until earlier this year. [00:26:36] Speaker 04: FDA had reappointed him. [00:26:37] Speaker 04: His original term expired in January of 2014. [00:26:40] Speaker 04: He was present at a TIPSAC meeting in April of 2014, and he did not resign until earlier this year. [00:26:49] Speaker 04: He would have continued on the committee, would have continued to receive confidential information. [00:26:53] Speaker 04: FDA statement quoted in the government's... I just want to get back to my question, though. [00:26:57] Speaker 02: How does the use injunction against the FDA's use of the report protect you... Oh, against the use of the report? [00:27:03] Speaker 04: No, it doesn't relate to that injury. [00:27:07] Speaker 04: The use injunction relates to our other injuries. [00:27:09] Speaker 02: All you asked for was an... Right, so what redress... [00:27:13] Speaker 02: Could a judgment in this case provide you for whatever you allege are the past injuries you've suffered as a result of this testimony? [00:27:21] Speaker 02: You said it was a past injury. [00:27:24] Speaker 02: How is it redressed by the relief you sought in this litigation? [00:27:26] Speaker 04: The past can't be undone, but it can be prevented from continuing. [00:27:31] Speaker 02: How is the use injunction that you obtained in this case? [00:27:34] Speaker 02: All you asked for was injunction. [00:27:35] Speaker 02: You didn't ask for damages. [00:27:36] Speaker 02: You didn't ask for any injunction against their testimony. [00:27:39] Speaker 02: You only asked for an injunction, and that's all you got. [00:27:42] Speaker 04: You have an appeal. [00:27:44] Speaker 04: We asked for declaratory relief, and we asked for multiple forms of injunction. [00:27:48] Speaker 04: If you look at the prayer for relief in each of our complaints, [00:27:53] Speaker 04: We asked for multiple forms of injunction, not merely a use injunction. [00:27:58] Speaker 04: We asked for an example of that. [00:27:59] Speaker 02: Did you ask for an injunction against these witnesses' testimony? [00:28:01] Speaker 02: I did not see that. [00:28:02] Speaker 02: I got your prayer for relief here, and I don't see that anywhere. [00:28:05] Speaker 04: We asked that a legend be put on the report that it was an illegal product of bias. [00:28:12] Speaker 04: which would have tied a tin can to it. [00:28:14] Speaker 02: And if we started this with the confidential information problem, that doesn't do anything. [00:28:18] Speaker 02: Our understanding is redressed, and I'm trying to figure out how your complaint would have redressed that particular injury, not the other injuries. [00:28:26] Speaker 04: I agree that the use injunction does not address the access to confidential information. [00:28:33] Speaker 04: That injury is addressed [00:28:35] Speaker 04: by preventing people with conflicts of interest from serving on the committee and getting our confidential information. [00:28:43] Speaker 04: How? [00:28:43] Speaker 04: If they're not on the committee, they don't get the information. [00:28:46] Speaker 04: If they're recused from a particular matter, they don't get the confidential information relating to that matter. [00:28:52] Speaker 02: That's future injury, not past injury. [00:28:54] Speaker 02: Okay, so how is that future injury not speculative? [00:28:59] Speaker 02: You started with, this is past injury, it's already happened. [00:29:01] Speaker 02: And there's no redress for that past injury. [00:29:03] Speaker 02: All right, and so going forward, if there... [00:29:08] Speaker 02: They've already got confidential information. [00:29:10] Speaker 02: I guess you're saying that's just water under the bridge. [00:29:11] Speaker 02: There's nothing to be done about that. [00:29:13] Speaker 02: And what allegation do you have now that this report is done that they're going to get more confidential information? [00:29:18] Speaker 04: There's more to the district court's order than the use injunction. [00:29:22] Speaker 04: There's also what I call the compliance directive, that the members of the committee not have unwaived conflicts of interest. [00:29:33] Speaker 04: If they, and if they're serving with unwaived conflict of interest, they should not be receiving our confidential information. [00:29:41] Speaker 01: But if it's waiving, but I take it, Mr. Cooper, that you're also defending the use injunction? [00:29:47] Speaker 04: I certainly am. [00:29:48] Speaker 04: That relates to our second and third injuries. [00:29:51] Speaker 04: But if it's waived, you've got no protection again against... You said you only have... If FDA waives the conflict of interest, they can do that. [00:30:01] Speaker 02: Okay, so then there's no protection for your use of confidential information going forward either? [00:30:05] Speaker 04: Only if they pay the price of giving a waiver. [00:30:08] Speaker 04: And if they make a waiver, they have to make findings. [00:30:10] Speaker 02: It might make you feel better to have a waiver on the record, but that does nothing to redress the injury that you've alleged. [00:30:15] Speaker 04: No, that would address other injuries. [00:30:17] Speaker 02: I understand, but I'm one injury at a time. [00:30:19] Speaker 02: I'm sorry, but I really want to do one injury, because it's easier to do these one at a time. [00:30:22] Speaker 02: You have to have standing for each injury asserting. [00:30:26] Speaker 04: Each of our injuries is concrete, real, particular to us, traceable to FDA's appointments of these people, and it's meeting by meeting approvals of their participation. [00:30:37] Speaker 04: And it's redressable, and indeed is redressed, in fact, [00:30:41] Speaker 04: by one of the two parts of the district court's order. [00:30:44] Speaker 04: I agree. [00:30:44] Speaker 04: The use injunction does not redress the confidential information issue. [00:30:48] Speaker 04: It addresses, it redresses the other two injuries. [00:30:52] Speaker 04: The confidential information issue is redressed prospectively by the compliance directive. [00:30:59] Speaker 04: So that Dr. Samet or others similarly situated don't henceforth receive our confidential information and then use it to consult against competitors and in formulating their testimony against us in courtrooms. [00:31:13] Speaker 02: And that's understanding that they are already under federal law prohibitions against using that confidential information in any way. [00:31:21] Speaker 04: They can do it without disclosing it. [00:31:24] Speaker 04: It can occur. [00:31:26] Speaker 04: simply in their minds. [00:31:27] Speaker 04: They can't put it out of their minds. [00:31:29] Speaker 04: That's recognized in cases that give protective orders in civil cases. [00:31:33] Speaker 04: We cite one, the digital case. [00:31:35] Speaker 02: You're not injured by what's in their minds. [00:31:36] Speaker 02: I'm sorry? [00:31:37] Speaker 02: You're not injured by what's in their minds. [00:31:38] Speaker 04: Yes, we are. [00:31:39] Speaker 04: We're injured by the advice they give or the advice they refrain from giving or testimony they give or refrain from giving without disclosing our confidential information, but influenced by it. [00:31:51] Speaker 06: Our confidentiality can save them from mistakes. [00:31:53] Speaker 06: Wouldn't that normally be detectable from the testimony and you and your client's knowledge of what information is in the public domain? [00:32:04] Speaker 04: It might or might not be detectable. [00:32:05] Speaker 04: And in the consulting, we're not present at all. [00:32:07] Speaker 04: Those are private meetings. [00:32:10] Speaker 02: But you have absolutely no basis, no evidence. [00:32:12] Speaker 02: And we're at summary judgment now, not at the 12th to 6th stage. [00:32:15] Speaker 02: What did you come forward at summary judgment to establish standing that shows that there is an actual risk that these folks are going to violate federal law? [00:32:24] Speaker 02: Subject themselves to extend as a trade secret to potential criminal prosecution by consulting. [00:32:29] Speaker 02: Do you have any evidence that they've done that? [00:32:31] Speaker 04: That's only if they disclose it. [00:32:34] Speaker 04: It's just common sense. [00:32:38] Speaker 04: And it's common sense that's been accepted by courts that grant protective orders against the use of confidential trade secret information outside a particular case. [00:32:47] Speaker 04: And we cited such a case. [00:32:49] Speaker 02: And you're going to have to get those protective orders in every case. [00:32:52] Speaker 04: That's right. [00:32:54] Speaker 04: So we've got hundreds and hundreds and hundreds of cases, but we have to go for a protective order in every case in which one of these people testify. [00:33:02] Speaker 02: The injury then is that you have to go for no injury. [00:33:05] Speaker 04: The injury is that is that it's in their minds. [00:33:08] Speaker 04: It's relevant to the to the consulting that they give it creates. [00:33:12] Speaker 04: not really a financial interest, but an appearance conflict. [00:33:14] Speaker 04: If you look at the evidence we put before FDA about the editorial in the Boston Globe, the columns in the Wall Street Journal and the Washington Examiner, the statements by the three public interest groups, the two bloggers, one of whom testifies against tobacco companies, none of these people is a friend. [00:33:31] Speaker 04: They all saw the conflict. [00:33:34] Speaker 04: from this kind of thing, from their access to our information and from the role they play as consultants and as testifying experts who recurrently give the same testimony over and over again, which is directly the subject of the menthol report. [00:33:53] Speaker 02: Can you talk about your injury that you say arises from them skewing the menthol report, given their subsequent testimonial interests? [00:34:01] Speaker 04: Absolutely. [00:34:02] Speaker 04: The conclusion of the menthol report is that menthol has an adverse public health effect, no public benefit, and the public health would be better if menthol cigarettes were removed from the market. [00:34:17] Speaker 04: That result [00:34:18] Speaker 04: That recommendation is based not on any toxicity, but rather on the role of menthol in its physiological effects with respect to initiation, addiction, and cessation. [00:34:32] Speaker 04: And those are covered in chapters three and six of the report. [00:34:36] Speaker 04: Chapter three, the lead author was Dr. Benowitz, one of the three challenge members. [00:34:40] Speaker 04: at in the administrative record at Benowitz 399 and 528, you will find that Dr. Benowitz asked FDA for permission to work with Dr. Henningfield on chapter 3. [00:34:53] Speaker 04: That permission was given. [00:34:55] Speaker 04: So Dr. Henningfield presumably consulted with [00:34:58] Speaker 04: Dr. Benowitz about Chapter 3, which is the subject of their testimony. [00:35:02] Speaker 04: Chapter 6, the other leg under the conclusions in the mental report, the lead authors included Dr. Salmon and Dr. Benowitz. [00:35:11] Speaker 04: So these people who testify against us shaped the key chapters of the report that led to the conclusion in Chapter 8. [00:35:19] Speaker 04: that menthol should be removed from, would benefit the public health if it were removed from the market. [00:35:25] Speaker 04: And FDA has issued an advance notice of proposed rulemaking, which is an investment of resources by the agency, which reports that the agency had done a preliminary scientific investigation on its own, and that that preliminary scientific investigation indicates, that's FDA's verb, [00:35:42] Speaker 04: that the menthol has an effect on the public health and the advance notice also expressly talks about and asks comments on a possible ban or restrictions on the sale of menthol cigarettes. [00:35:54] Speaker 01: So this is not speculation. [00:35:55] Speaker 01: You also allege an injury based on a decline in stock prices and I wonder if you have [00:36:02] Speaker 01: any case in which we've found, you know, outside the securities law context, such an injury to support standing and also whether... That's gone from the case. [00:36:12] Speaker 04: It's gone from the case. [00:36:13] Speaker 04: That's gone from the case. [00:36:14] Speaker 04: As a result of the merger of Laura Lord and Reynolds, that's gone. [00:36:17] Speaker 04: Sorry. [00:36:20] Speaker 02: Can I get back to the, so you've got your argument here about the impact on the content of the report, but now you need to tie it to an injury to you, and my understanding is that it was that these folks have, I thought the number was nine, in excess of 900. [00:36:36] Speaker 02: plans to testify going forward. [00:36:39] Speaker 02: Is that number correct? [00:36:41] Speaker 04: Combined, the three of them? [00:36:42] Speaker 04: We give the numbers in our brief and in our submission to FDA. [00:36:46] Speaker 04: That could be right. [00:36:47] Speaker 04: I haven't confirmed the number. [00:36:48] Speaker 02: As you said, there are many hundreds of designations. [00:36:56] Speaker 02: Are any of those [00:36:57] Speaker 02: Did you make a showing for provisional summary judgment as to whether those trials involve menthol cigarettes that are coming forward or not? [00:37:05] Speaker 04: It doesn't have to be. [00:37:06] Speaker 04: I'm just asking whether you have shown... We did not that they were menthol cigarettes, but the testimony about menthol occurs even in non-menthol cases. [00:37:13] Speaker 02: I understand, but if I thought it were important to you whether you had an injury that it actually be a menthol trial coming up, would the record show that any one of those [00:37:23] Speaker 02: 900 trials involve menthol cigarettes? [00:37:27] Speaker 04: Well, the record shows testimony about menthol. [00:37:31] Speaker 02: Now, going forward, you've said there's all these contracts to testify in these future cases. [00:37:35] Speaker 02: Are any of those future cases that you're facing menthol cigarette cases? [00:37:40] Speaker 04: There have been, there was testimony, I think at least one was. [00:37:44] Speaker 04: It's in the record. [00:37:46] Speaker 04: Yeah, I'm talking about the future ones. [00:37:48] Speaker 04: A declaration of Mr. Latham, Will Latham, and he attaches to it three transcripts of testimony by Dr. Henningfield. [00:37:59] Speaker 04: And I think in at least one of those cases, the plaintiff was a menthol smoker. [00:38:05] Speaker 02: That's a past one. [00:38:06] Speaker 02: I was talking about that. [00:38:07] Speaker 04: No, it's after the report. [00:38:09] Speaker 02: Oh, I see. [00:38:10] Speaker 02: Okay. [00:38:10] Speaker 02: I misunderstood. [00:38:11] Speaker 04: It's after the report. [00:38:12] Speaker 02: Okay. [00:38:12] Speaker 02: And you don't have any sense going forward? [00:38:15] Speaker 04: I can check and either write a letter or do something. [00:38:18] Speaker 04: I have it here and I can check it. [00:38:20] Speaker 02: That wasn't part of a submission you made to the district court. [00:38:22] Speaker 02: It was just these trials. [00:38:23] Speaker 04: It was part of the submission to the district court on summary judgment. [00:38:26] Speaker 01: I know this goes to the merits and we may never get there, but the [00:38:32] Speaker 01: The notion that a scientist whose field is to study the harm, the acknowledged harm that cigarettes cause to health. [00:38:44] Speaker 01: with a scientist and whose views are only as good as the science that supports them would somehow have a conflict based on giving a view subject to cross examination in a trial and giving a view in a government commission or helping an investigation in a government commission subject to notice and comment before any rulemaking. [00:39:11] Speaker 01: It's just I'm having a little trouble grasping [00:39:15] Speaker 04: any harm that flows from that [00:39:32] Speaker 04: One is you have somebody who is a paid expert witness who testifies recurrently, multiple times, hundreds of times here. [00:39:42] Speaker 01: There are hundreds of cases. [00:39:43] Speaker 04: To a fixed position. [00:39:45] Speaker 04: He or she doesn't testify one day on one thing, one day on something else. [00:39:49] Speaker 04: The same position over and over again, and that position [00:39:53] Speaker 04: is at the core of what the advisory committee's work is to be about. [00:39:58] Speaker 04: How does that answer my question? [00:40:00] Speaker 04: Well, such a person has a conflict of interest, and I would suggest to you in the [00:40:07] Speaker 04: And the citizens for the CRE amicus brief, they cite the case in Ray Kensington, which discusses the judicial disqualification provision 28 U.S.C. [00:40:17] Speaker 04: 455, which is very similar on appearance conflicts to the OGE regulation 5 CFR 2635.502A. [00:40:32] Speaker 04: And in both of those, the test is whether a reasonable person would view, would question the impartiality of somebody. [00:40:41] Speaker 04: It is inconceivable that you could have a judge who testifies as an expert witness over and over and over again on an issue that the judge will decide in a case. [00:40:52] Speaker 04: That judge could not be impartial. [00:40:54] Speaker 04: Neither could Dr. Henningfield or Dr. Benowitz, or we contend Dr. Samit, [00:41:01] Speaker 04: Given the testimony that they are committed to give and that they have given, and we've given quotations and examples that are in the record over and over and over again, that cigarette manufacturers, whether it's a menthol case or not, design cigarettes to make them more addictive, and an example of that is the use of menthol. [00:41:19] Speaker 01: I'm not sure I see that, because one is a judge who's supposed to apply a lot of fact in a particular case, [00:41:26] Speaker 01: And the other is an expert talking about a scientific fact that's subject to investigation and verification, and every different jury or finder of fact in every different trial needs to have that explained by a scientific expert. [00:41:40] Speaker 01: So it's no secret and no showing of bias that that person would say the same thing again and again. [00:41:46] Speaker 01: In fact, [00:41:48] Speaker 01: It seems to undermine your claim that these people have been doing this long before and will continue to do it long after the participation in the federal advisory committee. [00:41:58] Speaker 04: If they were to subscribe to a mental report that contradicted their testimony, [00:42:04] Speaker 04: They would lose future opportunities. [00:42:07] Speaker 01: That's right. [00:42:07] Speaker 01: That's a financial interest. [00:42:09] Speaker 01: That's right. [00:42:09] Speaker 01: And presumably if the science supported that, they would do that and then they would come and be a witness for your client. [00:42:16] Speaker 01: Inconceivable. [00:42:18] Speaker 04: I'm sure you have. [00:42:19] Speaker 04: Dr. Benowitz or Dr. Hennington is going to testify for us. [00:42:22] Speaker 01: I'm just saying that there is a scientific discipline at the core of both what the witnesses in your cases do and what these advisory committee witnesses do. [00:42:33] Speaker 01: And again, I think it relates to the question of how you're harmed, even though it's a merits question. [00:42:44] Speaker 01: I'm not sure that I see the bias cashing out in the way that you are pointing to in each of the harms that you've identified. [00:42:52] Speaker 04: Well, lots of other reasonable people did see the bias and wrote about it, and we put that in the record. [00:42:58] Speaker 04: And under 2635-502A, that's dispositive. [00:43:02] Speaker 01: And if the government had done a formal waiver, you would still be claiming standing, though, right? [00:43:11] Speaker 04: But I don't know that we'd be here if they had granted waivers. [00:43:14] Speaker 04: I think it would be very difficult to overcome a waiver. [00:43:16] Speaker 04: You don't think it would be? [00:43:17] Speaker 04: Pardon? [00:43:18] Speaker 04: I think it would be very difficult for us to get a waiver set aside by a court. [00:43:22] Speaker 01: Not to get the waiver set aside, but if they had, part of your harm, I thought, was that they didn't go through the waiver process and make that public. [00:43:30] Speaker 01: And that you said, I thought you said before, that if they had done that, there would be a tin can tied to the report. [00:43:36] Speaker 01: At least you'd be able to point to that. [00:43:37] Speaker 04: No, if we put a legend on the report saying this was done by conflict. [00:43:43] Speaker 04: Would we still be injured if there were radios? [00:43:46] Speaker 02: Yes. [00:43:46] Speaker 04: Would we have a legal case? [00:43:47] Speaker 04: I'm not sure. [00:43:49] Speaker 02: Well, if they get, if they do the waiver, you don't get any legend on the report. [00:43:52] Speaker 02: It would have been done in... No. [00:43:54] Speaker 04: But you get to tax them. [00:43:54] Speaker 04: I'm saying, yes, if they did a waiver, we'd have to come up with a claim, and I don't know that we could. [00:43:59] Speaker 01: But you'd be able to say publicly, because it would be made public. [00:44:01] Speaker 01: We could say publicly, yes. [00:44:03] Speaker 04: We could argue publicly that they acknowledge there were conflicts. [00:44:05] Speaker 01: But you can still say that. [00:44:06] Speaker 01: You can say, I mean, you're basically saying that here. [00:44:08] Speaker 01: Yeah, there's a report, but look at who did it. [00:44:11] Speaker 04: Right, but if SBA can use the report, [00:44:14] Speaker 04: If the federal courts say FDA can use the report despite all this. [00:44:19] Speaker 01: And you can come into notice and comment rulemaking and say, boom, look at these people, how biased they were, and bring in all your best scientists who say they're wrong. [00:44:28] Speaker 04: No, but if FDA can use the report, then the plaintiff's lawyer can argue, if it's good enough for FDA, it's good enough for a jury. [00:44:35] Speaker 04: Or it's good enough in some other form. [00:44:37] Speaker 02: That's not your injury now. [00:44:38] Speaker 02: That can't possibly be your injury now, because that hasn't happened. [00:44:41] Speaker 02: That's not an imminent injury. [00:44:44] Speaker 02: Hasn't used it. [00:44:45] Speaker 02: FDA has to do its own investigation. [00:44:47] Speaker 04: FDA's been barred from using it. [00:44:49] Speaker 02: I'm talking about whether you have standing in this case to remain in possession of that injunction. [00:44:56] Speaker 02: And that is, it can't turn on the fact that FDA might, in the future, decide to rely on the report in addition to its own statutorily mandated investigation, can it? [00:45:08] Speaker 04: We presented evidence in the record. [00:45:10] Speaker 02: that the FDA relies on the advisory committee... I know, you said you realized on its advisory committees, but this wasn't actually Congress's advisory committee. [00:45:19] Speaker 02: This wasn't the FDA's idea. [00:45:21] Speaker 02: Congress mandated this advisory committee. [00:45:23] Speaker 02: Do you have evidence of how often they have relied on congressionally mandated advisory committees when Congress has also mandated that they first undertake their own independent scientific investigation? [00:45:33] Speaker 04: With respect, I would submit that doesn't make a difference. [00:45:35] Speaker 04: The FDA picks the people on the committee, it staffs the committee, [00:45:39] Speaker 04: Particularly, it chooses the chairman who controls the committee. [00:45:43] Speaker 04: And the evidence is that FDA relies very heavily. [00:45:47] Speaker 04: And indeed, there are statements by FDA itself that it would not act without hearing from the committee. [00:46:00] Speaker 04: Let me get that. [00:46:08] Speaker 04: There are statements from FDA to the committee that it was not going to act until it heard from the committee. [00:46:15] Speaker 04: And there's a memo in the record from Dr. Deaton in March of 2011 to the committee saying that it will not act without the committee. [00:46:28] Speaker 04: And there's a statement at the committee itself. [00:46:32] Speaker 04: Yes, this is on [00:46:35] Speaker 04: in the administrative record page 6781. [00:46:41] Speaker 02: It must be emphasized. [00:46:44] Speaker 04: This is the administrative record 6781. [00:46:48] Speaker 04: It must be, quote, it must be emphasized that no regulatory decision on menthol and cigarettes has been made and that the input of the members of the TIPS Act is extremely important in this process, close quote. [00:46:59] Speaker 04: And then it administrative record 159 in the briefing materials for the first committee meeting, quote, the FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized. [00:47:17] Speaker 04: So FDA said publicly that it's going to pay attention to this committee. [00:47:21] Speaker 04: And the history is when a committee is unanimous, as Dr. Salad managed to make this committee unanimous, the FDA relies on its recommendations 92 percent of the time. [00:47:32] Speaker 04: And there's no contrary evidence in the record. [00:47:36] Speaker 04: That's a real possibility of injury. [00:47:40] Speaker 04: That's not speculative. [00:47:41] Speaker 04: And given their investment of resources in the advance notice of proposed rulemaking and their own scientific evaluation, FDA seems reasonably committed. [00:47:53] Speaker 02: Thank you very much. [00:48:03] Speaker 02: Sure, and we'll give you two minutes. [00:48:05] Speaker 05: Okay, just a couple of very quick points. [00:48:09] Speaker 05: The statements that FDA wouldn't act without the committee were obviously made by the committee, like an FDA representative on the committee while the committee was in existence. [00:48:21] Speaker 05: And of course, [00:48:22] Speaker 05: At that time, FDA wasn't going to act before the committee issued the report that had been mandated by Congress. [00:48:31] Speaker 05: The reference to other committees and the FDAs following the recommendations we pointed out in our reply brief, those committees are not [00:48:44] Speaker 05: They are generally advisory committees that are set up to deal with specific drug or device approvals and notice and comment rulemaking is generally not involved in those cases. [00:48:58] Speaker 01: Mr. Stern, is there any situation in which [00:49:03] Speaker 01: there would be judicial review if there was a complete failure of any kind of conflict screening? [00:49:12] Speaker 01: Is there any judicial check on this function? [00:49:18] Speaker 05: I don't. [00:49:25] Speaker 05: There might be some extraordinary circumstance. [00:49:27] Speaker 05: But again, whether or not the [00:49:32] Speaker 05: We have inspector generals, we have congressional oversight. [00:49:36] Speaker 05: If there were really rampant disregard of the conflicts laws by the agencies, I don't think that that's going to... Well, what about a highly selective violation of the conflict laws? [00:49:52] Speaker 06: That seems more of a problem. [00:49:56] Speaker 06: It's not likely to reach the scale of something leading to congressional intervention, but the effect on adversely affected firms can be, as you hear. [00:50:13] Speaker 05: The way that the conflicts laws work, they don't actually trigger agency determinations. [00:50:21] Speaker 05: It's your responsibility as an employee to recuse yourself if you think you have a conflict. [00:50:29] Speaker 05: And you can go to your agency and try to get a waiver from a conflict. [00:50:36] Speaker 05: But the responsibility remains with you. [00:50:40] Speaker 06: I'm sure the agency has some overview, even if there isn't an explicit request for a waiver. [00:50:48] Speaker 05: What it can do is it can tell you that this will not protect you. [00:50:54] Speaker 05: It can tell you we don't think there's a conflict. [00:50:57] Speaker 01: I mean, there's criminal prosecution available. [00:50:59] Speaker 05: Yes, it cannot protect you. [00:51:01] Speaker 05: I mean, it can tell you that it's not going to initiate disciplinary proceedings. [00:51:08] Speaker 05: I mean, that's what the OGE reg says. [00:51:11] Speaker 05: You should get agency. [00:51:12] Speaker 05: advice, if they can tell you they're not going to institute proceedings, but if you've in fact violated the conflicts law, the fact that you were open and square with the agency may be taken into account, but it's not going to be dispositive. [00:51:25] Speaker 01: It just struck me that you relied on Webster versus Doe, which is a very different [00:51:30] Speaker 01: very different kind of context and you know putting a cloak over the executive of non-reviewability because of national security interests and this is it just it struck me that it was a little incongruous and but I hear you that you that is you're taking that kind of [00:51:45] Speaker 01: broad position. [00:51:47] Speaker 05: I just don't think, I mean, I've sort of come out to thinking that the best way of looking at it is that there's no final agency action. [00:51:55] Speaker 05: That when an agency says, when you come to your designated agency official and you say, do I have a conflict? [00:52:05] Speaker 05: And the agency official goes, I don't think so. [00:52:07] Speaker 05: That that's not final agency action. [00:52:11] Speaker 05: you know, the rest of the world can come and challenge. [00:52:14] Speaker 01: But they're seeking declaratory relief. [00:52:15] Speaker 01: They're kind of forcing your hand by seeking declaratory relief from the final agency decision makers on this point. [00:52:23] Speaker 05: Well, but there still is, no, but they're challenging things that warrant themselves final agency action. [00:52:28] Speaker 05: I understand. [00:52:29] Speaker 05: I think that's one of the reasons why it's not justiciable. [00:52:34] Speaker 02: That's part of your answer to Judge Williams then, right? [00:52:37] Speaker 02: I assume you would agree that if there were rampant conflict of interest problems, that that would be at least an argument someone would have. [00:52:45] Speaker 02: And there were resulting rule that relied on that conflicted evidence and information that that would be a basis for an arbitrary and capricious challenge. [00:52:55] Speaker 05: Yes, absolutely. [00:52:57] Speaker 05: We think that when action is taken, all arguments are available. [00:53:05] Speaker 05: We're not saying that it escapes judicial review in that way. [00:53:08] Speaker 05: In that sense, it is a timing question. [00:53:14] Speaker 06: I want to make sure your answer to that is that with a clear display of violations of the rules and a follow-on adoption of a rule by FDA, these claims would be cognizable in that context. [00:53:33] Speaker 05: Yes, you could make an argument that the agency officials were biased, personnel were biased, procedures were biased. [00:53:42] Speaker 01: And that would be in an APA arbitrary and capricious challenge? [00:53:46] Speaker 05: I think it would be part of, it would be arbitrary and capricious contrary to law. [00:53:50] Speaker 05: I don't know how it would get framed, but those are all ways [00:54:00] Speaker 06: Insofar as your briefs argue that these alleged violations are completely non-justiciable, that does not apply to the contest of an issued rule. [00:54:19] Speaker 05: I think that you could argue in the same way that people argue that agency officials are biased, or that they could say that the advisory committee members are biased, to think that it's far more important when you're talking about agency employees or officials. [00:54:37] Speaker 05: They've got a lot more authority. [00:54:39] Speaker 05: They don't act in a purely advisory capacity. [00:54:42] Speaker 05: But it's an argument you could make about them. [00:54:44] Speaker 05: It's an argument you could make about the advisory committee members. [00:54:48] Speaker 02: You have an answer to their point that after the mental report issued one of these experts testified in a mental cigarette that was the. [00:55:00] Speaker 05: That's the same passage that was discussing earlier with judge pillar. [00:55:04] Speaker 05: It is not a mental trial as such, and my understanding is that as for these several hundred future sort of testimony, that it's not that they've got contracts to do it, that they've been listed as potential witnesses, sort of by a lot of people. [00:55:21] Speaker 02: They've got money on the line. [00:55:23] Speaker 05: I mean, they've got their expert witnesses. [00:55:26] Speaker 05: It's one of the things that they do. [00:55:29] Speaker 05: We're not disputing that. [00:55:30] Speaker 05: And just one final, small point on me. [00:55:33] Speaker 06: I'm sorry. [00:55:35] Speaker 06: Use the term not a menthol trial. [00:55:38] Speaker 06: When you say that, you mean simply that the cigarettes in question, particular cigarettes in question, were not menthol cigarettes. [00:55:47] Speaker 05: The cigarette was a menthol cigarette in that particular trial. [00:55:53] Speaker 01: It's that the legal issues aren't about the contributing effect of the menthol feature to any harm to the plaintiff. [00:56:02] Speaker 01: That's correct. [00:56:03] Speaker 01: Whereas the menthol report is talking about it's the menthol contribution that makes us more attractive to children or makes it more attractive to certain subcontributions. [00:56:13] Speaker 05: And Dr. Anfield, in the part that the plaintiffs have provided specifically says that with respect to a individual, [00:56:22] Speaker 05: He can't even sort of opine as to the effect of mental. [00:56:27] Speaker 06: In the very example that you gave, the witness is talking about probabilistic effects from mental, right? [00:56:37] Speaker 05: Yeah, that's right. [00:56:43] Speaker 05: I mean, we're really at several stages away from an actual injury. [00:56:50] Speaker 05: We're talking about somebody who gave an opinion about in a menthol report context. [00:56:56] Speaker 05: It was his opinion before. [00:56:58] Speaker 05: It continues to be his opinion. [00:57:00] Speaker 05: And the question is. [00:57:01] Speaker 06: I just wanted to get clear what the conscious text is. [00:57:06] Speaker 06: You're talking about a witness who speaks to the probable effects of [00:57:13] Speaker 06: Either menthol in the cigarettes or even the availability of menthol cigarettes. [00:57:17] Speaker 05: Yeah, I mean, I don't want to... I mean, the materials in the joint appendix and all that the witness is doing there is he's being asked about what he might testify about. [00:57:29] Speaker 05: And so that's all that we have. [00:57:31] Speaker 05: I mean, we don't even know they actually ever testified. [00:57:35] Speaker 03: Yeah, I understand that. [00:57:35] Speaker 02: If you had a future case coming up, so it's not far away, it's coming up next... the month after the menthol report issues. [00:57:44] Speaker 02: And it was actually about, one of the litigation issues was whether it was menthol itself that helped to predict this person, keep this person on because it doesn't burn the throat as much or whatever the arguments are, but it was actually focusing in part on the effects of having menthol in the cigarette in the addiction. [00:58:03] Speaker 02: Would you have a different answer on injury? [00:58:06] Speaker 05: No, it would be the same answer. [00:58:08] Speaker 05: I think that the fact that you once took part in an advisory committee report, the fact that you then later testify about men's law unless there was like some evidence that you were. [00:58:19] Speaker 05: And this is the claim. [00:58:21] Speaker 05: It's not simply that you're testifying. [00:58:22] Speaker 05: It's that you stacked it. [00:58:23] Speaker 05: I mean, that's the argument that they made. [00:58:26] Speaker 02: Well, the reality is, I mean, I have the numbers up, and it's like 900 trials, and more than 900 trials coming. [00:58:31] Speaker 02: That's a lot of money on the line. [00:58:36] Speaker 02: If these people had produced a report, if these three experts had produced a report and they got in there and they studied, they talked to the other nine colleagues and they said, perhaps we've been wrong. [00:58:46] Speaker 02: Oh my gosh, menthol makes it safer. [00:58:51] Speaker 02: But if we issue their report, if we issue, it's not, this is whether they've been injured. [00:58:58] Speaker 02: If they issue that report, these folks are out of business. [00:59:02] Speaker 02: They're not going to get called in those other 900 cases. [00:59:05] Speaker 02: That's a lot of money down the drain. [00:59:07] Speaker 02: It seems to me that's not speculative. [00:59:08] Speaker 02: That is very, very concrete. [00:59:09] Speaker 05: It really does seem speculative, because it makes an assumption that people of [00:59:17] Speaker 05: that what they were doing was stacking the report because it's the [00:59:22] Speaker 02: The question is whether they had a direct financial stake. [00:59:26] Speaker 05: That's a merits question. [00:59:27] Speaker 02: Their point is that they are injured by the fact that these folks go and create this report that then makes them better witnesses in 900 cases. [00:59:40] Speaker 02: And it seems to be blinking reality to say that they would have gone into that not realizing, maybe it wouldn't have driven it, but not realizing that a different answer from that report means 900 trials. [00:59:51] Speaker 06: So it would have to be that they stack the report because that has to be the harm. [01:00:03] Speaker 06: They come in thinking Menthol is terrible for a variety of reasons. [01:00:08] Speaker 06: And after discussion with committee members, they come to see that it's more complicated and so forth. [01:00:16] Speaker 06: So that firm conclusion is solvent, possibly even reverse, which one would hope would be the way people would react in such a committee. [01:00:34] Speaker 06: all the revenue coming from testimony in those trials is now out. [01:00:41] Speaker 06: It's a classic conflict of interest. [01:00:44] Speaker 05: That would be, we disagree. [01:00:46] Speaker 05: I mean, I just think it's one thing that whether it's a conflict of interest is a merits point. [01:00:52] Speaker 05: I don't think that the fact that you might be a witness in a future case in which menthol could possibly be an issue creates a conflict of interest. [01:01:02] Speaker 05: And what's very clear [01:01:03] Speaker 05: from plaintiffs counsel's presentation is their position is if you consistently testified against the tobacco industry that's a conflict and a computer's conflict and you can't be on the committee this is you can't be on the committee absent a waiver that's absent a waiver that's right but and of course [01:01:30] Speaker 05: had thought that there was a conflict, then it could have made the determination. [01:01:36] Speaker 05: But it didn't think that there was a conflict. [01:01:39] Speaker 05: And just on a very small point about the confidential information and continuing to be on the committee, again, all these determinations about conflicts have to be made on a matter-by-matter basis. [01:01:56] Speaker 05: sort of supposed conflict or dissolvable where the supposed conflict existed are not the matters that would be before the committee and would be necessary to make a new determination about whether the agency thought there was a conflict assuming that anything was brought to their attention that suggested that and then whether to waive the conflict if they thought that was the case. [01:02:21] Speaker 02: Thank you. [01:02:22] Speaker 05: Thank you. [01:02:22] Speaker 02: The case is submitted.