[00:00:01] Speaker 01: Good morning, Your Honors, and may it please the Court, Josh Turner on behalf of the Appellants. [00:00:05] Speaker 01: I'd like to reserve four minutes for rebuttal if I can. [00:00:08] Speaker 01: After more than a dozen states sued the FDA and other federal officials to enjoin the 2023 Mephepristone REMS, six additional states moved to intervene to ensure that their views were adequately represented and expressed [00:00:23] Speaker 01: They sued the same defendants, asserting the same APA claims, challenging the same FDA action. [00:00:30] Speaker 01: All of that made intervention plainly appropriate under Rule 24, and this Court's requirement to liberally construe Rule 24 in favor of intervention. [00:00:40] Speaker 01: But the District Court held differently, and if that holding becomes circuit precedent, [00:00:45] Speaker 01: it will majorly impact litigants moving forward, such as environmental interest groups and even my state colleagues on the other side. [00:00:53] Speaker 01: So while today they oppose intervention, it will not be long before their own sovereign interests are on the line, and they want those interests represented. [00:01:02] Speaker 05: So that's- But is it clear? [00:01:04] Speaker 05: I want to look at the standing, the standing issue. [00:01:08] Speaker 05: Because as I hear you, you're talking intervention, but we have that preliminary question of standing. [00:01:16] Speaker 05: And if I understand it correctly, the case brought by Washington and others is basically going back and declaring all of these E-T-A-S-U improper. [00:01:36] Speaker 05: What Idaho wants to do, as I understand it, and some of your other related states, is really to [00:01:46] Speaker 05: challenge the elimination of the in-person dispensing. [00:01:50] Speaker 05: Is that correct? [00:01:51] Speaker 05: Is that the gist of your case? [00:01:53] Speaker 01: That's right, Your Honor. [00:01:54] Speaker 01: The ultimate goals of the litigants, the plaintiffs, and the proposed interveners is different. [00:02:01] Speaker 01: I think that underscores the adequacy of representation point, which demonstrates that intervention is appropriate. [00:02:07] Speaker 01: But as it pertains to standing and your question, [00:02:10] Speaker 01: I don't think that is material to standing, because the standing analysis looks at the harm to the states. [00:02:18] Speaker 01: agency action that is being challenged by Washington and its cohort is the same agency action that is being challenged by the six intervening states. [00:02:28] Speaker 04: I'm not sure that's right. [00:02:29] Speaker 04: Can you tell me what your strongest argument is for injury to Idaho? [00:02:32] Speaker 04: When you say they're the same, it seems to me that there's a difference on what we have here in the presentation of cost, the economic injury in particular. [00:02:43] Speaker 04: Could you address that? [00:02:44] Speaker 01: Sure. [00:02:45] Speaker 01: Just to clarify, the only basis for Washington to come into court and challenge the FDA's action was the final agency action that implemented the new 2023 REMS, and that is the agency action that's in view. [00:02:58] Speaker 01: Now, the economic harm to Idaho and to South Carolina and Iowa, these allegations, there are several. [00:03:06] Speaker 01: Economic harm that you're getting at, which I think is the strongest basis, is the Medicaid reimbursement that is implicated. [00:03:13] Speaker 01: And in paragraph 54, this is 2ER82, Idaho plainly alleges that women in- As the FDA recognized, elimination of the in-person dispensing requirement has been shown to result in more emergency and urgent care visits. [00:03:29] Speaker 04: I've been looking closely at this. [00:03:30] Speaker 04: This is paragraph 54. [00:03:32] Speaker 04: That's the sentence you want us to be looking at? [00:03:35] Speaker 04: Yes. [00:03:35] Speaker 04: I need some help with this, because it refers to, we said, as the FDA recognized. [00:03:41] Speaker 04: Now, in the motion to intervene, there's a proposed complaint that was lodged. [00:03:47] Speaker 04: That's correct. [00:03:47] Speaker 04: And there was a letter attached to it. [00:03:49] Speaker 04: And so I've looked at that letter. [00:03:51] Speaker 04: Is that where I'm supposed to be looking for support for the as the FDA recognized? [00:03:55] Speaker 01: Paragraph 35 of the proposed complaint alleges that the FDA admits that elimination of in-person dispensing requirement increases emergency room and urgent care visits. [00:04:07] Speaker 01: So that's an allegation in the complaint. [00:04:08] Speaker 05: But I'm looking for support for it. [00:04:10] Speaker 05: Yeah, and that says there's no apparent increases in serious adverse impact. [00:04:15] Speaker 05: The letter goes on to state, what I'm having trouble with there is I understand your theory [00:04:23] Speaker 05: but I'm having some trouble translating it into legal specificity and not too many layers of, I don't want to say speculation, but attenuation, I'll call it attenuation. [00:04:37] Speaker 05: And I'm, in thinking about it, I'm looking at the Supreme Court's caution in one of the many USV Texas cases, because it seems to me that you have layer upon layer upon layer upon layer [00:04:53] Speaker 05: not having the in-person, and then this happens, and then that person might get sick, and then if they got sick, then they maybe would go to the emergency room, maybe not. [00:05:01] Speaker 05: But if they did go to the emergency room, then there could be costs, and then that could be a cost to the state under the Medicaid. [00:05:12] Speaker 05: Why is this not just too attenuated, given the literally one paragraph allegation? [00:05:21] Speaker 01: So there's a lot of answers that I think will help clarify this question. [00:05:25] Speaker 01: Okay. [00:05:25] Speaker 01: So if I can take through them, I'll do my best to be efficient. [00:05:27] Speaker 01: Thank you. [00:05:28] Speaker 01: The first framing point I'd make is this is at the pleading stage. [00:05:31] Speaker 01: In order to circuit precedent, the pleadings can be alleged generally, and the pleadings assume that more specific facts will be brought to bear [00:05:39] Speaker 01: after at a later stage to support the general allegation. [00:05:42] Speaker 04: And you could do that. [00:05:43] Speaker 01: And we can do that. [00:05:44] Speaker 01: If you look at the declaration, this is outside the record in this case, but the declaration that the state of Idaho and the state of Missouri submitted in the related Alliance for Hippocratic Oath case. [00:05:55] Speaker 04: But you know, we can't do that. [00:05:57] Speaker 04: So we're looking at the record we've got here. [00:05:59] Speaker 01: But I'm saying we can do that. [00:06:00] Speaker 01: You asked whether we will be able to do that. [00:06:02] Speaker 01: And I'm saying in another case, we already have done that. [00:06:05] Speaker 01: And so, but at the pleading stage, the allegations have to be accepted as true, and under the Maya precedent of this court, general allegations are enough. [00:06:12] Speaker 01: Second, the Texas case is not support at all for the federal government's argument about attenuation. [00:06:19] Speaker 01: That case dealt with redressability. [00:06:21] Speaker 01: In fact, the court said that Texas's allegations regarding economic harm [00:06:25] Speaker 01: We're sufficient for an injury in fact. [00:06:27] Speaker 01: So the question here is, are the allegations sufficient for injury in fact? [00:06:31] Speaker 01: Yes, they are. [00:06:32] Speaker 01: Redressability is a different question. [00:06:34] Speaker 04: Are sufficient for injury in fact because you could make them sufficient, or you think these are sufficient? [00:06:40] Speaker 01: They are sufficient. [00:06:41] Speaker 01: Under ASAR, which was decided at the preliminary injunction stage, the attenuation there I think is even greater. [00:06:47] Speaker 04: So forget attenuation for a minute. [00:06:50] Speaker 04: You can come back to that if you will. [00:06:51] Speaker 04: But you just said that the allegations here are sufficient to show injury. [00:06:54] Speaker 04: And I've got paragraph 54, right, at ER 82. [00:06:59] Speaker 04: And then the lodged complaint has a letter attached to it. [00:07:03] Speaker 04: And that starts at ER 98. [00:07:04] Speaker 04: Is there a paragraph in that letter or support in that letter for this contention that's in paragraph 54 about the [00:07:13] Speaker 04: that Idaho will incur increased expenses because of ER visits and urgent care? [00:07:20] Speaker 01: Certainly not in that letter, Your Honor. [00:07:24] Speaker 04: Where do I find support for this allegation in paragraph 54, please? [00:07:30] Speaker 01: That Idaho will incur additional Medicaid reimbursement costs due to the increased ER visits? [00:07:35] Speaker 01: I mean, that's not the type of specificity that would ever be reformed. [00:07:39] Speaker 04: Here's what I'm trying to figure out. [00:07:40] Speaker 04: It seems counterintuitive to me. [00:07:42] Speaker 04: I don't know if what you mean here is that there will be ER visits because people will maybe use the medication incorrectly, or whether you're really alleging that there will be a net increase cost. [00:07:56] Speaker 04: It seems to me you need a net increase cost, and I don't see that allegation here. [00:07:59] Speaker 04: I want to give you a chance to respond. [00:08:01] Speaker 01: Yeah, that is in paragraph 35, Your Honor, of the complaint, where the FDA admits that removing the in-person dispensing requirement, which has now happened with the 2023 REMS, will lead to increased more urgent care visits and ER visits. [00:08:17] Speaker 04: So we're talking past each other. [00:08:19] Speaker 04: I've seen that paragraph in the complaint, sir, and maybe I'm just belaboring the point. [00:08:23] Speaker 04: But to say that there'll be ER visits doesn't tell me there'll be a net increased cost to Idaho as compared to the status quo. [00:08:31] Speaker 01: And based on that allegation in 35, paragraph 54, [00:08:34] Speaker 01: the state of Idaho alleges that because there will be increased ER visits, the state of Idaho will incur increased additional Medicaid reimbursement expenses. [00:08:43] Speaker 01: I think those two are very... I mean, that is... It's just not speaking to my point, but I think you've answered it to the extent you can. [00:08:49] Speaker 01: Okay. [00:08:50] Speaker 01: I apologize, Your Honor. [00:08:51] Speaker 01: I think that the theory is pretty tightly connected in the fact that the FDA has admitted that removing in-person dispensing will lead to more [00:09:01] Speaker 01: ER visits. [00:09:02] Speaker 01: Because of the increased amount of ER visits, the state is going to be on the hook for additional Medicaid reimbursement expenses. [00:09:08] Speaker 01: That is the economic harm. [00:09:09] Speaker 01: Now, if the economic harm here isn't sufficient for Idaho, it's not sufficient for the other states either, because the district court relied on that same allegation regarding Medicaid increased expenses for Washington and its cohort. [00:09:23] Speaker 03: I think the difference is that in the Washington case, they're alleging direct cost. [00:09:29] Speaker 03: And you are alleging indirect cost, which in part is based on the independent decision of third parties, which the Supreme Court is cautioned saying, that's not enough. [00:09:41] Speaker 03: I mean, they do allege a different economic harm than you're alleging. [00:09:48] Speaker 01: In part, they allege implementation costs as a direct harm. [00:09:51] Speaker 01: But this circuit has never found that implementation costs satisfy Article III injury. [00:09:56] Speaker 01: In fact, the Fifth Circuit has. [00:09:57] Speaker 01: The Ninth Circuit, as far as I can tell, has not. [00:09:59] Speaker 01: And the reasons that courts have been hesitant to do so is because it would provide standing any time an agency creates a rule, because there's always going to be some type of implementation cost. [00:10:10] Speaker 01: Now, if the implementation costs are enough, then we would move to, we're going to have to, those same implementation costs, and we can amend our complaint to allege those, and we're in the same place. [00:10:20] Speaker 01: But let me move to, I think, a firmer basis. [00:10:22] Speaker 01: The plaintiff's injury alone is enough, okay? [00:10:25] Speaker 01: Injury for one is, or standing for one is standing for all. [00:10:29] Speaker 01: The federal defendants say, no, you can't do that because they're seeking different relief. [00:10:33] Speaker 01: Well, they're seeking further relief, not different relief. [00:10:35] Speaker 01: They are at least seeking to invalidate the 2023 REMS. [00:10:39] Speaker 01: So is Idaho and the other five states. [00:10:42] Speaker 01: And under town of Chester, the key requirement is that it has to be wholly different relief, not just further relief, but different relief altogether. [00:10:50] Speaker 01: And that's a sensible rule because for Article 3 purposes, the case and controversy requirement, the court needs to satisfy itself that it can hear [00:10:59] Speaker 01: a dispute. [00:11:00] Speaker 01: Here, there is a dispute that one party has standing to bring before the court regarding the 2023 REMS. [00:11:06] Speaker 01: Now, if the court finds that the 2023 REMS are invalid or unlawful, it will have a decision to make. [00:11:12] Speaker 01: What is the remedy? [00:11:13] Speaker 01: Does it invalidate the, does it vacate the REMS and reinstate the prior rule, which is the default rule, or does it go further? [00:11:22] Speaker 01: Either way, they're standing for Idaho to come in and assert its APA challenges. [00:11:26] Speaker 01: If I might interrupt on that. [00:11:29] Speaker 03: What do you make of the fact that the district court has limited the injunction to the original states? [00:11:37] Speaker 03: Idaho is excluded from that. [00:11:39] Speaker 03: Assuming that there's no nationwide injunction, how does that affect Idaho? [00:11:45] Speaker 01: For the preliminary injunction purposes, right now it does not. [00:11:48] Speaker 03: No, but it seemed reading between the lines. [00:11:51] Speaker 03: I think it seems to me that's where the district court's headed. [00:11:56] Speaker 03: I don't think... Well, given the concern about nationwide injunctions, yes, I mean, we've encouraged courts not to engage in nationwide injunctions. [00:12:05] Speaker 03: So if hypothetically that's the case, how is Idaho harmed by this? [00:12:10] Speaker 01: Well, there's still the harm to the elimination of the in-person dispensing requirement in neighboring states, which allows women in Idaho... That's pretty attenuated, yeah. [00:12:19] Speaker 01: Well, I don't think it's any more attenuated than the Azar harm, where you've got employers who are removing contraceptive coverage, which leads to women who might not get contraceptive coverage, which leads to the state having to reimburse contraceptive coverage for those women who have now lost that coverage. [00:12:36] Speaker 03: So in your brief, you say, well, we know we could have brought this separately. [00:12:40] Speaker 03: That's right. [00:12:41] Speaker 03: And you acknowledge that. [00:12:44] Speaker 03: But the only reason [00:12:46] Speaker 03: you give for not bringing it separately in Idaho is to say it would be judicially inefficient. [00:12:52] Speaker 01: Well, that's the whole purpose of Rule 24, Your Honor. [00:12:55] Speaker 01: The whole purpose is to consolidate and allow for efficient resolution of claims. [00:12:59] Speaker 03: You've got suits going on all over the country on this. [00:13:04] Speaker 01: Well, I think there's one additional suit. [00:13:05] Speaker 01: I don't know about others. [00:13:06] Speaker 01: And the five states that are not part of the Texas litigation have just as much grounds to seek vindication of their rights here. [00:13:15] Speaker 01: And there's- Well, you know, they do. [00:13:17] Speaker 05: But going to Judge Thomas's question, it just seems to me that the Washington suit is a very different suit than the one you want. [00:13:27] Speaker 05: You have a fairly directed relief, right? [00:13:31] Speaker 05: And that's to revive the status quo, declare these 2023 REMS unlawful. [00:13:39] Speaker 05: And they may well be. [00:13:40] Speaker 05: And that is a very razor strike suit. [00:13:45] Speaker 05: You now want to put that in the middle of Washington's suit, which is going way back, as to all of these claims, or all of these, I should say, restrictions, or they view as hurdles or restrictions. [00:13:59] Speaker 05: It just seems to me it's such a different lawsuit. [00:14:01] Speaker 01: It's not different at all. [00:14:02] Speaker 01: It is challenging the very same agency action. [00:14:05] Speaker 01: There is a difference in what the relief, the ultimate relief that is being sought, but that's not unusual in intervention. [00:14:12] Speaker 01: That happens all the time. [00:14:14] Speaker 01: In the Columbia River litigation, which involves six different- Well, when you say the same agency action, [00:14:22] Speaker 05: Which precise action are you aiming at here, the 2023 REMS? [00:14:28] Speaker 01: Yes, which is exactly what Washington and its co-plaintiffs also challenged explicitly. [00:14:35] Speaker 05: But the gist of their suit is completely different. [00:14:40] Speaker 05: It's like an upside down between you want to make sure we have these, they want to make sure you don't have these, and they go further. [00:14:49] Speaker 05: Because it seems to me what they're challenging [00:14:52] Speaker 05: is this whole bundle of what they claim are restrictions, which is totally outside of Idaho's claim or what Idaho wants to get out of this. [00:15:01] Speaker 01: That's not unusual, Your Honor. [00:15:02] Speaker 01: Consider an environmental litigation interest group or environmental litigation involving interest groups as some plaintiffs and states as plaintiffs on the other side. [00:15:12] Speaker 01: Their interests will often diverge when a federal agency takes an action [00:15:16] Speaker 01: let's say, regarding Bureau of Land Management use. [00:15:20] Speaker 01: Sometimes the environmental litigation groups will say, you haven't gone far enough. [00:15:25] Speaker 01: States will say you've gone too far. [00:15:26] Speaker 01: They're going in separate directions, but they're challenging the same state agency action. [00:15:30] Speaker 04: That's what's happening here. [00:15:31] Speaker 04: What's the best example of a case like that? [00:15:33] Speaker 04: Because that's exactly the way I think of it. [00:15:34] Speaker 04: They say that the government didn't go far enough, federal government, and you think they went too far. [00:15:38] Speaker 04: What's the best example of an analogy? [00:15:41] Speaker 01: Well, the one that's near and dear to the heart of Idaho is the Columbia River litigation that's been pending for. [00:15:47] Speaker 01: multiple decades, and involves multiple sovereigns and multiple environmental interest groups. [00:15:53] Speaker 01: And they all have divergent interests. [00:15:55] Speaker 01: And they are plaintiffs. [00:15:56] Speaker 01: And some have switched sides over the course of the decades, from defendants to plaintiffs, depending on what administration is doing what. [00:16:03] Speaker 01: But currently, Idaho is intervening as a plaintiff. [00:16:07] Speaker 01: And it has divergent interests from the sovereign tribal [00:16:13] Speaker 01: plaintiffs and from the state of Oregon. [00:16:16] Speaker 01: So I don't think this is unusual. [00:16:19] Speaker 01: It's certainly not unheard of. [00:16:21] Speaker 05: Now, I don't have much time, and I think that... But to be more precise, they might have some divergent interests, but it seems to me that what Washington is aiming at is something... This 2023 RAM might be like a subset, but that's not what they're trying to overturn, in effect. [00:16:41] Speaker 01: It's important, though, that it is because it's their entry into court based on the six-year APA statute of limitations. [00:16:47] Speaker 01: They could not bring this suit unless they were challenging the 2023 REMS. [00:16:51] Speaker 01: That's what makes this so focused. [00:16:54] Speaker 01: It is about the 2023 REMS. [00:16:55] Speaker 01: They might be wanting to go further, but they at least have to invalidate those REMS to get to where they ultimately want to be. [00:17:01] Speaker 01: I'm going to sit down now. [00:17:02] Speaker 01: I'm sure there's a lot that I'll be able to say on rebuttal. [00:17:04] Speaker 01: Thank you, guys. [00:17:04] Speaker 04: Thank you for your patience with our questions. [00:17:06] Speaker 04: We'll hear from opposing counsel, please. [00:17:08] Speaker 04: And you are splitting time. [00:17:10] Speaker 02: Yes. [00:17:11] Speaker 02: Good morning, Your Honor. [00:17:12] Speaker 02: Daniel Winnick for the FDA. [00:17:13] Speaker 02: And I have 10 minutes. [00:17:14] Speaker 02: And then my colleague, Ms. [00:17:15] Speaker 02: Grunberg, is arguing for the state plaintiffs. [00:17:17] Speaker 02: I'm not as tall. [00:17:20] Speaker 02: The court should affirm the denial of intervention on the ground that the movements lack standing. [00:17:26] Speaker 02: Let me start with this question of economic costs, which is, I think, you heard this morning, they think is their strongest basis for standing. [00:17:32] Speaker 02: And I want to make basically just two points about it. [00:17:35] Speaker 02: The first is, Judge Christen, I think you're asking exactly the right question when you're looking at whether [00:17:40] Speaker 02: they have alleged a net increase in their Medicaid costs as a result of the elimination of the in-person dispensing requirement. [00:17:47] Speaker 02: I think that is the basic reason the complaint is insufficient. [00:17:50] Speaker 02: So the complaint says, you've correctly identified there's one line, and there's a similar allegation for South Carolina, those are the only two that I counted in the complaint, that says the FDA has pointed to a few studies that if there's no in-person dispensing requirement, people may [00:18:06] Speaker 02: visit ERs or urgent care centers slightly more often for follow-up care. [00:18:11] Speaker 04: So that seems to be, counsel, to be comparing people who use this medication after having seen a care provider compared to people who use the medication without having seen a care provider. [00:18:24] Speaker 02: Yeah, I think that's right. [00:18:25] Speaker 02: So the FDA looks at three studies, and I'm not 100% sure whether in all three of those it was people who had never seen a care provider at all. [00:18:33] Speaker 02: But basically, they're comparing [00:18:35] Speaker 02: people who have received Mifeprestone dispensed in person to people who have received Mifeprestone dispensed without. [00:18:42] Speaker 04: Well, that's what I'm saying. [00:18:43] Speaker 02: Yeah. [00:18:43] Speaker 04: That's the comparison there, as opposed to a net. [00:18:46] Speaker 02: Correct. [00:18:46] Speaker 02: Yes. [00:18:46] Speaker 02: And it's looking at that one outcome measure, which is, do those people subsequently visit an ER or an urgent care center? [00:18:54] Speaker 02: And so that's the one outcome they've looked at. [00:18:56] Speaker 02: But as I think your questions reflected, that's one of thousands different outcomes that might bear on a state's overall Medicaid costs. [00:19:04] Speaker 02: I mean, others might include. [00:19:06] Speaker 02: are more people pursuing medication abortions as opposed to surgical abortions? [00:19:10] Speaker 02: Are more people carrying their pregnancies to term? [00:19:13] Speaker 02: Those are all things that could affect the state's ultimate Medicaid costs. [00:19:16] Speaker 02: And so the complaint doesn't come close to alleging that the state's Medicaid costs are on net actually going to be higher. [00:19:23] Speaker 02: I mean, it's an incredibly attenuated theory. [00:19:26] Speaker 05: One of his arguments in response to that is, well, we could, and when we talked about California versus Azar, where they do have specific projections, the state says, well, we could allege that. [00:19:39] Speaker 05: So then the question would be, should the case be remanded so that there could be amendment and specification? [00:19:47] Speaker 02: I was going to speak to Azar next. [00:19:48] Speaker 02: I'll start there. [00:19:52] Speaker 02: The causation theory in that case was radically more direct than this one. [00:19:56] Speaker 02: In that case, the states were challenging an agency action that had expanded the set of employers eligible for an exemption to the Affordable Care Act's contraceptive coverage requirement. [00:20:07] Speaker 02: And they said, when people don't get contraceptive coverage from their employers, they're going to get it from the states, and thus we're going to have higher Medicaid costs. [00:20:14] Speaker 02: That was common ground in that case. [00:20:17] Speaker 02: It was actually in the agency's regulatory impact analysis [00:20:20] Speaker 02: that if people aren't getting contraceptive coverage from their employers, they're going to get it from the states. [00:20:25] Speaker 02: So there was really no mystery there that the state's Medicaid costs were going to go up. [00:20:29] Speaker 02: To be clear, the federal government argued against standing in that case. [00:20:32] Speaker 02: I'm not conceding that there was standing, but it was a far more direct theory of causation than here. [00:20:36] Speaker 02: As to whether it should go back, the proposed complaint is what it is. [00:20:41] Speaker 02: They've had their chance to make their allegations. [00:20:43] Speaker 02: You know, they have to do that. [00:20:43] Speaker 04: I'm not sure it's quite fair, because they've had their chance, they lodged their complaint, and then there wasn't a ruling. [00:20:48] Speaker 04: Had there been a ruling on standing in the trial court, they would have been free to come back and take another run at it, right? [00:20:55] Speaker 04: As you've indicated, sort of like saying, well, if this weren't a complaint in intervention, if it were a complaint complaint, the district court would have had to rule on that and decide that amendment would be futile. [00:21:09] Speaker 02: Certainly if it were brought as an original complaint and you were applying, the district court were applying a 12b6 standard, that would be the usual rule. [00:21:16] Speaker 04: It wasn't. [00:21:17] Speaker 02: I appreciate it wasn't. [00:21:17] Speaker 02: But I think that may be a meaningful change. [00:21:20] Speaker 02: I mean, he was reviewing this on a motion to intervene. [00:21:23] Speaker 02: He denied intervention because they hadn't satisfied the rule 24 requirements. [00:21:28] Speaker 02: He didn't specifically comment on standing. [00:21:31] Speaker 02: Standing. [00:21:31] Speaker 05: And so that's the point. [00:21:33] Speaker 05: Maybe they can't do it. [00:21:35] Speaker 05: Maybe they can. [00:21:37] Speaker 05: But it does seem to me that [00:21:40] Speaker 05: Of course, if we were to rule that there's no standing, that's kind of a without prejudice rule in any event. [00:21:48] Speaker 05: They could come back and either file their own independent claim, which we've talked about, or they could try to come back again and establish their standing in this case. [00:22:00] Speaker 05: So the bottom line, which I would appreciate an answer to, is why shouldn't they be given that opportunity? [00:22:07] Speaker 02: I mean, I think my best stab at that, Your Honor, [00:22:09] Speaker 02: Intervention is disruptive to litigation, right? [00:22:12] Speaker 02: It interjects a new party into litigation. [00:22:14] Speaker 02: It can complicate litigation. [00:22:15] Speaker 02: It can create extensive delays because, of course, the denial of intervention of right is appealable. [00:22:20] Speaker 02: And so I'm not familiar with whether there is law on whether the sort of usual leave to amend generosity for complaints should be extended to motions to intervene. [00:22:30] Speaker 02: I can't find any. [00:22:31] Speaker 02: Yeah, no, but it actually doesn't strike me as a crazy notion to suggest that it should be less liberal because intervention is [00:22:38] Speaker 02: really complicating the ordinary flow of litigation. [00:22:41] Speaker 04: And so I do think- Well, sort of, but if you could just back up right there, because, of course, from where we're sitting, we're removed from this. [00:22:48] Speaker 04: But am I correct that the injunctions remain in place in this interim while this appeal is happening? [00:22:55] Speaker 02: Yeah, the preliminary injunction- But that's the status quo. [00:22:58] Speaker 02: It remains in place. [00:22:59] Speaker 02: The underlying litigation has been stayed pending the Supreme Court's forthcoming ruling in alliance. [00:23:03] Speaker 05: Right. [00:23:04] Speaker 05: That's a case that's going to be argued [00:23:05] Speaker 05: next week next week right so i'm trying to figure out i am not too bowled over by the complication of intervention because to the extent the case can go forward or not go forward it doesn't really have anything to do with the intervention as being complicating factor right [00:23:24] Speaker 02: If that maybe, Your Honor, to the extent the court rules quickly on this and it goes back, I mean, which is- There's not gonna be a delay, is it? [00:23:29] Speaker 02: Or could you just walk me through your theory that it would be- Well, I mean, hypothetically, if the court takes six months to write an opinion on this and then it's, you know, we're talking about- [00:23:36] Speaker 02: September and then it's been three months post a decision in Alliance. [00:23:40] Speaker 02: At that point it could be more disruptive litigation, but I'm not going to try to too hard to talk about it. [00:23:44] Speaker 05: We're not going to stand on that ground. [00:23:45] Speaker 05: Yeah. [00:23:46] Speaker 02: Yeah. [00:23:46] Speaker 02: No, no, no. [00:23:46] Speaker 02: I mean, I take the point. [00:23:48] Speaker 02: I'm not familiar either Judge Christian with whether there are cases extending to the context of intervention, the sort of ordinary rule about liberality of amendment for complaints. [00:23:56] Speaker 02: And I think there are reasons to think it shouldn't extend. [00:23:59] Speaker 02: In this case, I'm not going to say [00:24:01] Speaker 02: no, no, it's going to upend the world if they had that chance. [00:24:03] Speaker 02: We do think the complaint is plainly inadequate. [00:24:06] Speaker 05: Well, if we- I just want to say, though, if one of the points he makes is, yeah, you would like the outcome to be different, or the states would like the outcome to be different, but in fact, it's the very same agency action that is the 2023 REMS that are the focus of their intervention and the focus of the case. [00:24:29] Speaker 05: Do you disagree with that? [00:24:31] Speaker 02: So I don't disagree that as a formal matter they are both challenging the same agency action, but it is they're seeking utterly different relief. [00:24:38] Speaker 04: But isn't he right that it's one of those funny cases where the reason they're seeking different relief is one team thinks the government didn't go far enough and the other team thinks that the government went too far. [00:24:52] Speaker 04: So there's this overlap. [00:24:54] Speaker 04: The premise from which Washington starts its argument is exactly what they want to undo [00:25:01] Speaker 02: I agree that that is the premise of the case. [00:25:04] Speaker 02: I think Town of Chester tells you what to do with that in terms of whether they have to show standing, which is that if they are seeking different relief, they have to show independent standing, and they are plainly seeking different relief. [00:25:15] Speaker 04: Didn't Town of Chester remand for a determination on standing? [00:25:19] Speaker 02: It remanded for a determination of whether, yeah, in that case, the lower courts hadn't addressed standing, and so it remanded for whether. [00:25:27] Speaker 02: Actually, I think it may have remanded for whether they were in fact seeking different relief. [00:25:30] Speaker 02: here, I think it's quite clear that they are seeking different ... To take their most recent 28-J letter, they say the plaintiffs and the move-ins disagree regarding relief. [00:25:40] Speaker 02: Of course, I think that's clear to everybody who thinks about this case. [00:25:43] Speaker 02: They want the REMS to be stricter, and my friends, the plaintiff states want the REMS to be gone. [00:25:50] Speaker 02: That tells you everything you need from the standpoint of whether they have to establish standing. [00:25:54] Speaker 05: They're only counter ... They would then come back and say, well, at least their one counter was [00:25:59] Speaker 05: Washington got standing in this case, and they apparently don't see it as materially different the way the Washington Medicaid is implicated here. [00:26:10] Speaker 05: So what's the response to that? [00:26:13] Speaker 02: It's a fundamentally different theory of standing. [00:26:14] Speaker 02: I mean, to be clear, the federal government doesn't think the plaintiff states have standing here. [00:26:17] Speaker 02: Okay. [00:26:18] Speaker 02: We opposed the P.I. [00:26:20] Speaker 02: in part on those grounds. [00:26:21] Speaker 02: I'm sure if this court rules and says something on standing, you know, the issue of their standing may arise later in this litigation, but it is at a minimum a different theory [00:26:29] Speaker 02: of economic cost. [00:26:31] Speaker 02: They have said that they operate health care facilities, and so they have certain costs. [00:26:35] Speaker 02: And they've also said that they think the elimination of the in-person dispensing, or they think that the REMS makes people more likely to seek surgical abortions as opposed to medication abortions, which they say imposes additional costs. [00:26:46] Speaker 02: So it's just a fundamentally different theory of standing. [00:26:50] Speaker 02: From the standpoint of whether they need to establish an independent basis for standing, the only relevant question is, are they seeking different relief? [00:26:57] Speaker 02: This idea that what the [00:26:59] Speaker 02: What they are seeking is a subset of what the plaintiffs are seeking is just not right. [00:27:04] Speaker 02: It rests on the idea that the plaintiffs can't get what they're seeking. [00:27:06] Speaker 05: Are the plaintiffs seeking to declare the 2023 REMS invalid? [00:27:12] Speaker 02: What the plaintiffs are ultimately seeking is a ruling. [00:27:13] Speaker 05: Well, the answer to that is a yes or no. [00:27:16] Speaker 05: Are they seeking that? [00:27:19] Speaker 02: Yes, but what they want is to declare any REMS invalid, yes. [00:27:22] Speaker 02: And so they are seeking not just a subset, but diametrically opposed. [00:27:25] Speaker 04: Your position is that under Chester, they have to have independent standing. [00:27:28] Speaker 04: We know the district court didn't rule on standing. [00:27:30] Speaker 04: It seems you want us to rule on standing. [00:27:33] Speaker 04: Opposing counsel has represented that even if we decide these allegations are [00:27:39] Speaker 04: not that they're not true, but that they're insufficient, that they're too conclusory, that he should be given a shot to buttress his showing here, because he says he can do that. [00:27:49] Speaker 04: And of course, we're not going to look at something, as opposing counsel acknowledged, outside our record. [00:27:54] Speaker 04: What's your best argument that we should not remand, and we should rule on this here? [00:27:59] Speaker 02: My best argument is just, and I acknowledge there aren't cases of which I'm aware on either side of this, that the ordinary liberality of amendment for original complaints [00:28:07] Speaker 02: It's not obvious why that should extend to intervention, which is really, as a general matter, more disruptive to litigation. [00:28:14] Speaker 02: We haven't spoken about their other theory of standing in their brief quasi-sovereign injury. [00:28:18] Speaker 02: I'm happy to respond to anything they say. [00:28:19] Speaker 04: Just one more thing on this point. [00:28:20] Speaker 04: Forgive me. [00:28:21] Speaker 04: One more thing on this point. [00:28:22] Speaker 04: If they filed this motion for mandatory intervention, if the district court had ruled on it and decided that there wasn't standing, they would have been free to just refile another motion to intervene, right? [00:28:35] Speaker 02: I'm not sure that's right. [00:28:37] Speaker 02: I mean, it might be collaterally stopped. [00:28:38] Speaker 02: With a different basis for it? [00:28:40] Speaker 02: Yeah. [00:28:40] Speaker 02: I mean, that may be. [00:28:41] Speaker 05: I would think most district courts would be quick to... They could file an independent case. [00:28:44] Speaker 05: They could certainly do that. [00:28:45] Speaker 02: They could file an independent case, yes. [00:28:47] Speaker 02: I'm not aware of whether there's precedent on whether they could come back and file a second motion or being... I think there is. [00:28:52] Speaker 04: But anyway, you're over time, so do you want to wrap up, please? [00:28:56] Speaker 02: Yes. [00:28:56] Speaker 02: My only wrap up was if the court has questions about their theory of standing they didn't discuss today, I'm happy to take those. [00:29:02] Speaker 02: Otherwise, we ask that the denial of intervention be affirmed. [00:29:04] Speaker 04: Thank you for your argument. [00:29:05] Speaker 02: Thank you. [00:29:14] Speaker 00: Good morning, your honors. [00:29:15] Speaker 00: May it please the court, Emma Grunberg, representing the state of Washington and the 17 other plaintiff states. [00:29:21] Speaker 00: I'm here with co-counsel Andrew Hughes. [00:29:23] Speaker 00: Intervention is not a vehicle to force a new dispute onto existing litigation, yet that is exactly what Movements seek to do. [00:29:31] Speaker 00: They seek to graft a single new claim onto this lawsuit, a challenge to FDA's removal of Mifflin Pristone's in-person dispensing requirement. [00:29:40] Speaker 00: That claim is not at issue in this case. [00:29:43] Speaker 00: It is, however, at the center of another case, Alliance for Hippocratic Medicine versus FDA, a clear alternative forum in which Movements filed amicus briefs [00:29:53] Speaker 00: and could have sought to intervene at any time. [00:29:55] Speaker 00: In fact, Idaho belatedly did seek intervention in that case, which the district court granted. [00:30:01] Speaker 00: And in two weeks, the Supreme Court will hear oral argument on Muvin's precise claim. [00:30:07] Speaker 00: Move-ins have no need to intervene here to protect any claimed interest. [00:30:11] Speaker 00: The district court properly denied intervention and to turn to the Rule 24 standard for intervention as of right. [00:30:19] Speaker 00: The core of that standard is that the disposition of the lawsuit must, as a practical matter, impede the move-in's ability to protect their interest. [00:30:27] Speaker 00: And this lawsuit does not impede the move-in's ability [00:30:30] Speaker 00: to bring a separate APA claim on their challenge at any time, assuming they have standing. [00:30:36] Speaker 00: And I want to take issue with this idea that the plaintiff states and the movements are challenging the same agency action. [00:30:43] Speaker 00: Administrative agencies often make decisions at a similar timeframe. [00:30:47] Speaker 00: For example, they pass amendments to a certain set of regulations in the same year on the same day. [00:30:54] Speaker 00: But the challenges here are two different decisions that the FDA made. [00:30:59] Speaker 00: One, the decision to reimpose restrictions that are currently in place. [00:31:02] Speaker 00: And the other, the FDA's decision that another restriction was no longer necessary. [00:31:06] Speaker 00: And I want to really concentrate on the legal differences here. [00:31:10] Speaker 00: Because this is not a case where one party says the government hasn't gone far enough. [00:31:14] Speaker 00: The other party says the government is going too far. [00:31:16] Speaker 04: Not a case. [00:31:17] Speaker 00: No. [00:31:17] Speaker 00: What our case is about is that the FDA did not have the legal authority [00:31:22] Speaker 00: to impose REMS on Mifepristone. [00:31:25] Speaker 00: And the default is for every prescription drug, there are no REMS. [00:31:30] Speaker 00: There are only REMS in place for 60 out of the more than 20,000 prescription drugs approved for marketing in the United States by the FDA. [00:31:39] Speaker 00: And so there is a very high statutory standard for imposing a REMS. [00:31:43] Speaker 00: It means that the drug has to have serious inherent risks of death, prolonged hospitalization, incapacity, [00:31:50] Speaker 00: And it means that the FDA has to, by statute, by the FDCA, has to consider patient access in deciding to impose a REMS. [00:31:58] Speaker 00: And here, Mifepristone does not have those serious inherent risks. [00:32:03] Speaker 00: It's a drug that's safer than Tylenol. [00:32:05] Speaker 00: It's a drug that the FDA has approved with no restrictions. [00:32:09] Speaker 00: The exact same drug in a much higher dose that patients take daily. [00:32:13] Speaker 00: for Cushing syndrome under a different name, Coralyn. [00:32:17] Speaker 00: And also the FDA acknowledged that it didn't consider patient access in imposing these restrictions, which it is statutorily required to do. [00:32:25] Speaker 00: So that is our legal claim. [00:32:27] Speaker 00: And as a legal matter, you know, just to think about intervention here, the summary judgment briefing would be completely different. [00:32:32] Speaker 00: It would be about, you know, there would be [00:32:35] Speaker 00: This is not a case where movements seek to come in on one side or another of an existing dispute. [00:32:40] Speaker 00: They do not seek to defend the restrictions that currently exist. [00:32:44] Speaker 00: They seek to challenge a different agency action, the decision to remove a previous restriction. [00:32:50] Speaker 05: And I would also note that the underlying case here- But when you unpack that, I'm just trying to see what is the agency action. [00:33:04] Speaker 05: Washington has challenged, um, the 2023 REMS, correct? [00:33:11] Speaker 05: Correct. [00:33:12] Speaker 05: And the theory being there should be none at all. [00:33:15] Speaker 00: Correct. [00:33:16] Speaker 00: We don't, we don't think restrictions are appropriate. [00:33:18] Speaker 00: The focus of our case is that there are currently restrictions that the FDA did not have the legal authority to impose. [00:33:26] Speaker 05: But in doing that, the agency [00:33:30] Speaker 05: decision that you're challenging then is the 2023 REMS imposition, correct? [00:33:35] Speaker 05: That's correct. [00:33:38] Speaker 05: And if that is declared improper because there was no authority to issue it, then Idaho would be out of luck in effect, correct? [00:33:57] Speaker 00: I don't agree with that, Your Honor, for a couple of reasons. [00:34:00] Speaker 00: The first is there's just no indication that a ruling in this case would have preclusive effect on the in-person dispensing requirement. [00:34:07] Speaker 05: The district court has been... Well, I probably was imprecise. [00:34:10] Speaker 05: They would be out of luck in this case. [00:34:13] Speaker 00: In this case, you know, perhaps, but I think that the key point is our argument this entire case is about the current restrictions that are imposed on Mifflin Pristone. [00:34:22] Speaker 00: The Supreme Court is considering Muvin's precise claim [00:34:26] Speaker 00: whether the in-person dispensing requirement was improperly taken away. [00:34:31] Speaker 00: And so if the Supreme Court reaches the merits of that issue, it will obviously be binding on the district court in this case and all courts. [00:34:40] Speaker 00: If the Supreme Court doesn't reach the merits, then the district court would be bound jurisdictionally by any prior decision if that jurisdictional doctrine was appropriate. [00:34:52] Speaker 05: Okay, so can we just play out what might happen? [00:34:54] Speaker 00: Sure. [00:34:55] Speaker 05: If the Supreme Court were to determine that the in-person dispensing elimination was improper, then there would be no reason for Idaho to intervene in this case. [00:35:12] Speaker 05: Is that right? [00:35:14] Speaker 05: Because you still would have the broader question of REMS, or going way back to these ITASUs, or however it's pronounced. [00:35:23] Speaker 00: That is correct, but we don't think there's any reason for Idaho to intervene, even if the Supreme Court doesn't. [00:35:28] Speaker 00: I understand. [00:35:29] Speaker 00: Yes. [00:35:29] Speaker 04: Because your argument is that there was not authority to do what they did as to the Rams. [00:35:35] Speaker 00: Exactly. [00:35:36] Speaker 00: There are two different claims. [00:35:37] Speaker 00: They aren't seeking to come in on either side. [00:35:39] Speaker 00: They're seeking to add a third leg to the stool. [00:35:42] Speaker 00: And, you know, I would note, just as a practical matter, [00:35:45] Speaker 00: This case is not stayed in waiting for the Supreme Court. [00:35:50] Speaker 00: We didn't think a stay was appropriate. [00:35:52] Speaker 00: The parties have actually been actively litigating the scope of the administrative record based on the scope of the claims the plaintiff states bring. [00:35:59] Speaker 00: So just as a practical matter, that would have to start over. [00:36:02] Speaker 04: So it's your point that there would be, so it's not delay, it's disruption. [00:36:06] Speaker 04: You think there would be disruption because of the administrative record being compiled? [00:36:10] Speaker 00: Well, it's not just the administrative record. [00:36:11] Speaker 00: It's really the scope of this case. [00:36:13] Speaker 00: The summary judgment briefing [00:36:15] Speaker 00: We have agreed to wait for summary judgment motions until the Supreme Court decision comes down. [00:36:20] Speaker 00: But really my point is intervention would double the size of this case. [00:36:24] Speaker 05: It would add- So why shouldn't we wait? [00:36:27] Speaker 05: That would be my question because I'm thinking, okay, we didn't really play out the second thing. [00:36:31] Speaker 05: We said that the Supreme Court might rule that elimination was appropriate. [00:36:37] Speaker 05: But if the Supreme Court were to rule [00:36:41] Speaker 05: on whatever grounds that this in-person dispensing elimination was legitimate or not legally a problem, then you're going to wait on your summary judgments until you get that ruling. [00:37:01] Speaker 05: Is that right? [00:37:02] Speaker 00: That's right. [00:37:03] Speaker 05: So my question is, [00:37:06] Speaker 05: Why would we jump through all these legal gymnastics on standing and intervention and not wait for the Supreme Court ruling, because it doesn't look like it would delay your case in any way, even though technically this case has not stayed? [00:37:23] Speaker 00: We don't think we don't object if the court would like to wait until the Supreme Court decision. [00:37:28] Speaker 00: We have no objection to that. [00:37:29] Speaker 00: We just don't think it's necessary because under the well-settled rule 24 standards, we don't think the movements have met those standards here. [00:37:38] Speaker 00: And I would just note again that Idaho has been granted intervention in the Alliance case. [00:37:44] Speaker 00: The other states could have moved to intervene at any time. [00:37:47] Speaker 00: Their very claim [00:37:49] Speaker 00: is being actively litigated in a clear alternative form right now. [00:37:52] Speaker 00: I don't think it would be appropriate for plaintiff states to seek to intervene in that case to bring our separate claim. [00:37:58] Speaker 00: It is not a bad thing that the litigation on the same general subject matter, the safety of Mr. Pristone, percolates in different courts when the fundamental legal claims are different. [00:38:11] Speaker 00: And grafting movement's claim onto this case would double the size of the case and make the legal issues completely different. [00:38:17] Speaker 00: And I did just want to make a one point on standing. [00:38:20] Speaker 00: I see I have one minute left. [00:38:22] Speaker 00: We haven't taken a position on standing. [00:38:24] Speaker 00: We think the court should affirm on intervention in Rule 24, which are over and above standing. [00:38:30] Speaker 00: But plaintiff states' claims of standing are very different, I would just note, from movements' claims. [00:38:36] Speaker 00: Plaintiff states' claims are of direct economic harm. [00:38:39] Speaker 00: We directly employ doctors and pharmacists who have to comply with the existing REMS now. [00:38:44] Speaker 00: and that causes significant unrecoverable costs. [00:38:47] Speaker 00: We put in several declarations of hundreds of hours to comply with REMS that are not in place for virtually any other drug in the country, certainly not one with a- Isn't it whether you have standing? [00:38:58] Speaker 00: Yes, I understand, but I'm just responding because the movements have claimed that our claim of standing rises and falls with theirs. [00:39:06] Speaker 00: I do completely disagree with that. [00:39:08] Speaker 04: In the district court, I would just note- Any place in the record where they've alleged or shown that there's a net increase? [00:39:13] Speaker 00: No, and I would note that at plaintiff's supplemental record, page 51, the FDA determined that there does not appear to be a difference in adverse events between periods where the in-person dispensing requirement was being enforced and periods when it wasn't. [00:39:28] Speaker 00: And then, of course, there's also the question of what would be the cost if women were getting procedural abortions and carrying pregnancies to term. [00:39:38] Speaker 00: So there is just no analysis of economic harm here. [00:39:41] Speaker 04: Thank you for your argument. [00:39:43] Speaker 00: Thank you. [00:39:46] Speaker 04: Counsel, you have three minutes. [00:39:51] Speaker 05: I think we saw you in Seattle last week, so the state of Idaho is keeping you busy, apparently. [00:39:55] Speaker 01: They are. [00:39:56] Speaker 01: It's good to see you again, Judge. [00:39:58] Speaker 01: Real briefly, I want to start with the Supreme Court decision. [00:40:01] Speaker 01: I agree that it would be prudent to defer deciding this case until the Supreme Court issues its decision. [00:40:08] Speaker 01: The case is not stayed, that's true, but nothing is happening beyond settling the administrative record, which there was an order issued just a couple days ago on that. [00:40:17] Speaker 01: I don't know if there's further motions work to be done on that, but the litigation in the case is not going to materially move forward until the Supreme Court decides the substantive issue. [00:40:30] Speaker 03: Regarding standing, I don't want to get... So following up on that, why is the disposition of this case [00:40:39] Speaker 03: How will that impede your interest? [00:40:40] Speaker 03: You've intervened in the Supreme Court case, which can just resolve the issue. [00:40:47] Speaker 03: To this case, [00:40:50] Speaker 03: has been confined to the states, at least at this point, to the states that have filed the suit. [00:40:58] Speaker 03: And you have an alternative remedy, you can just file your suit in IDO. [00:41:02] Speaker 03: So how does this case impede your ability to pursue any of that? [00:41:10] Speaker 01: If you're going to the 24A factor about impairment, first, Idaho isn't the only state here, so there are other states. [00:41:17] Speaker 01: Resolution of the Supreme Court decision will not necessarily resolve all of the claims here. [00:41:22] Speaker 01: It could be kicked on standing, which would leave all of the issues alive. [00:41:25] Speaker 01: Third, there's a claim at issue here, the notice and comment claim brought by the six intervening states, that is not at issue in any case anywhere in the country. [00:41:32] Speaker 03: Are you sure about that? [00:41:34] Speaker 03: not by us. [00:41:36] Speaker 03: Tell me, you've got two cases in Virginia and one in Hawaii, I'm aware of. [00:41:40] Speaker 01: None of the plaintiffs interviewing states here have brought a notice in common claim except here. [00:41:45] Speaker 01: And then the whole purpose of Rule 24 is not to have dueling district courts in the same circuit deciding the same issue. [00:41:50] Speaker 01: That's the whole point. [00:41:52] Speaker 03: Better talk to Hawaii, then. [00:41:55] Speaker 01: Regarding standing, on economic harm, [00:41:58] Speaker 01: I think I understand your question now, Judge Christin, the net increase. [00:42:03] Speaker 01: And the word additional in paragraph 44 speaks to that. [00:42:05] Speaker 01: And under this court's—and maybe that doesn't satisfactorily answer your question. [00:42:09] Speaker 04: It begs the question about the comparison, sir, and I'm not trying to be difficult, but as I read it— No, I want to answer your question. [00:42:13] Speaker 04: I think—well, I appreciate that, because we didn't do so well the first time around, so maybe we're communicating better. [00:42:18] Speaker 04: But if the difference is, people who you've misused Mipha Pristone after seeing a care provider, as opposed to people who use it to [00:42:26] Speaker 04: without seeing a care provider. [00:42:28] Speaker 04: If that is the comparison, that's one thing about, and it seems then intuitive that there would be perhaps more urgent care or emergency room visits if the drug is misused. [00:42:37] Speaker 04: But that is a far cry from a net increase. [00:42:40] Speaker 04: To Idaho and that's what I don't see here. [00:42:42] Speaker 04: So now if you I'm sure you understand my question now And I appreciate your circling back on it. [00:42:47] Speaker 04: But is that alleged anywhere? [00:42:50] Speaker 01: I think it is if you wear the paragraphs preceding 54 all I think it starts whatever that section starts at okay, it's [00:42:58] Speaker 01: all describe the increased, the net effect of the new REMS, how they increase risk overall to the specific population in Idaho of women. [00:43:08] Speaker 01: That is what precedes paragraph 54, and what 54 is summing up. [00:43:15] Speaker 01: Because of all of these new increased risks to women based on the 2023 REMS, [00:43:22] Speaker 01: This is going to cause Idaho to incur additional medical expenses. [00:43:27] Speaker 01: That is specifically talking about and situating the court into a very new space post-2023 REMS. [00:43:35] Speaker 01: So I think that addresses the comparison. [00:43:38] Speaker 01: We're not talking about before. [00:43:39] Speaker 01: We're talking about after. [00:43:40] Speaker 01: I'm over my time. [00:43:41] Speaker 01: I did want to say one thing about the quasi sovereign interest, because this is a really thorny area of law. [00:43:48] Speaker 01: But I think it can be simplified by simply noting that, [00:43:51] Speaker 01: Massachusetts, the EPA, the Wyoming case from 1995 with the Supreme Court, all have to have meaning. [00:44:00] Speaker 01: And Bracken did not eliminate those cases, did not overrule those cases. [00:44:05] Speaker 01: Quasi-sovereign interests of states and the ability to enforce a legal code are at stake here. [00:44:13] Speaker 03: Now, the allegation... So if it's confined to Washington, how does that impair your sovereign interests? [00:44:19] Speaker 01: I'm glad you brought that up, because I did not answer that point of your previous question. [00:44:23] Speaker 01: And I do want to say, I don't think there's any way that ultimately, if plaintiffs get what they want here, that they will get a patchwork injunction that invalidates the rule for 18 states in the country, but allows the REMS to be enforced [00:44:38] Speaker 01: in the other thirty-something states. [00:44:40] Speaker 01: That's not how invalidation of an agency rule works, I don't think. [00:44:44] Speaker 01: Thank you, Your Honors. [00:44:44] Speaker 04: Thank you all for your argument and advocacy. [00:44:47] Speaker 04: We appreciate it very much. [00:44:49] Speaker 04: We'll take this case under advisement and stand in recess.