[00:00:01] Speaker 03:
Case number 20-5048 et al.

[00:00:02] Speaker 03:
Mr. Juice et al.

[00:00:05] Speaker 03:
Appellants versus the Food and Drug Administration.

[00:00:08] Speaker 03:
Mr. Wood for Appellants.

[00:00:09] Speaker 03:
Ms.

[00:00:09] Speaker 03:
Powell for the Appellees.

[00:00:15] Speaker 01:
Good morning, counsel.

[00:00:17] Speaker 04:
Good morning.

[00:00:20] Speaker 04:
Good morning.

[00:00:21] Speaker 04:
May it please the court, Jonathan Wood for the Appellant Vape Shops.

[00:00:24] Speaker 04:
The deeming rule imposes ruinous burdens on small vape shops and manufacturers like the appellants.

[00:00:30] Speaker 04:
By FDA's own estimates, the rule will impose costs in excess of $100,000 for each product line, a prohibitively expensive burden that will force many companies to close.

[00:00:40] Speaker 04:
Yet despite the significant impacts, the rule was issued in violation of the Appointments Clause.

[00:00:45] Speaker 04:
The official that signed and issued the rule was not properly appointed.

[00:00:49] Speaker 04:
She was not nominated by the president, not confirmed by the Senate.

[00:00:53] Speaker 04:
Ultimately, FDA seeks to avoid scrutiny of this constitutional violation by asking the court to accept two reported ratifications

[00:01:00] Speaker 04:
But these ratifications are contrary to the common law of agency and therefore Supreme Court precedent.

[00:01:06] Speaker 04:
They cannot be squared with this court's precedence on ratification and ultimately would render the Appointments Clause a dead letter in the rulemaking context.

[00:01:14] Speaker 04:
If an agency can deny a party relief this easily by a mere ratification, there's little reason for any plaintiff to try to vindicate the Constitution's core structural protections under the Appointments Clause.

[00:01:28] Speaker 04:
I'd like to begin by discussing why each ratification fails under this court's and Supreme Court precedent.

[00:01:35] Speaker 04:
First, NRA Political Victory Fund says that ratifications are governed by the common law of agency.

[00:01:40] Speaker 04:
It cites favorably to the Wagner decision, which says that ratification cannot take place after a challenge to the action has already been filed.

[00:01:50] Speaker 04:
Here, that clearly is the case.

[00:01:52] Speaker 04:
The Gottlieb ratification did not take place until well after, more than a year after

[00:01:57] Speaker 04:
this challenge was filed, and therefore it cannot be accepted.

[00:02:04] Speaker 01:
It also can be- Did you make that argument in the district court?

[00:02:08] Speaker 04:
We did challenge the legitimacy of the Gottlieb ratification, and we relied on NRA Political Victory Fund for that.

[00:02:16] Speaker 04:
I understand that.

[00:02:18] Speaker 01:
The question is, did you make the argument you're currently making that it's after you file the complaint that the ratification

[00:02:29] Speaker 04:
We did not make it with that amount of specificity, and partly that's due to how the ratification came up.

[00:02:35] Speaker 04:
The ratification was made in the midst of briefing, and our only opportunity to respond would have been in the reply brief.

[00:02:41] Speaker 04:
But moreover, as we explained in our brief, the courts reached the merits of that argument, even if it doesn't think we raised it below.

[00:02:49] Speaker 04:
in order to preserve orderly process.

[00:02:51] Speaker 04:
The alternative would be for this court to issue a decision that conflicts with Supreme Court precedent.

[00:02:56] Speaker 04:
And so for that reason, given the importance of the structural guarantee of the Constitution and the need to reach the right result here, the court should- So we're talking about two different things here.

[00:03:07] Speaker 01:
I just want to be clear.

[00:03:08] Speaker 01:
You did not raise in the district court the post filing of the complaint argument you are now making.

[00:03:16] Speaker 01:
Is that correct?

[00:03:18] Speaker 04:
Yes, we did not specifically make that argument.

[00:03:21] Speaker 04:
We did argue the case in our NRA political victory fund.

[00:03:25] Speaker 04:
Yes.

[00:03:27] Speaker 04:
But we did not specifically call up its reference to Wagner.

[00:03:33] Speaker 03:
And Mr. Ward, if the ratification by Commissioner, I apologize, I don't actually know if it's Califf or Califf, was adequate, then that would not run into this problem, right?

[00:03:47] Speaker 04:
That's right, Your Honor.

[00:03:48] Speaker 04:
I pronounced it Caleb.

[00:03:49] Speaker 04:
I apologize if I get that wrong, too.

[00:03:52] Speaker 04:
But the Caleb ratification did take place before the action was filed.

[00:03:55] Speaker 04:
The problem with it is that there is no evidence that the Caleb had any intent to ratify the language.

[00:04:02] Speaker 03:
The government relies in part on legit tech where we seem to find a

[00:04:08] Speaker 03:
pretty pro forma and broad brush and non-specific ratification to be adequate.

[00:04:15] Speaker 03:
And in terms of actual support for and familiarity with the rule, the government points out that on, I think it's on the day the deeming rule was issued, that there was support from the, from Califf.

[00:04:30] Speaker 03:
So we both know as a formal matter and as a substantive matter, and I recognize that press release is not,

[00:04:37] Speaker 03:
If the formal, if the sort of pro forma ratification weren't enough, I'm not sure that that would suffice.

[00:04:46] Speaker 03:
But there's not a question here, is there?

[00:04:49] Speaker 04:
I think there is a question about the validity of the Califf ratification.

[00:04:55] Speaker 04:
I agree with your honor that the press release is clearly not enough.

[00:04:58] Speaker 04:
That does not satisfy the appointments clause.

[00:05:01] Speaker 04:
The official has to take responsibility for everything in

[00:05:04] Speaker 04:
the rule being issued.

[00:05:05] Speaker 04:
It would be like the equivalent of a judge letting a clerk write an opinion and issue it and later saying, or even at the same time saying, this is great.

[00:05:12] Speaker 04:
That is not sufficient for the properly appointed official to take responsibility.

[00:05:16] Speaker 03:
But are there any cases in which we have actually looked at the sort of the substance of the articulation by the ratifying official and said, we don't really

[00:05:32] Speaker 03:
think that you considered this and therefore that we invalidated it as not ratified.

[00:05:40] Speaker 04:
No, in part because this court has never faced a ratification like this.

[00:05:43] Speaker 04:
This is true boilerplate.

[00:05:45] Speaker 04:
We're not arguing that that Caleb didn't consider some factor he should have or wasn't specific enough.

[00:05:51] Speaker 04:
The language the government points to is something that is required under a rule to include in every delegation document like this.

[00:05:59] Speaker 03:
What about Wilkes-Barre and Legitech?

[00:06:05] Speaker 03:
I think we had

[00:06:07] Speaker 03:
language that talks directly about how a ratifier doesn't have to go in and talk chapter and verse about what, they did a whole category of actions.

[00:06:22] Speaker 03:
NLRB summarily affirmed.

[00:06:26] Speaker 03:
All right?

[00:06:26] Speaker 03:
That's right.

[00:06:27] Speaker 03:
I'm sorry, the reconstituted board ratified lots of actions altogether.

[00:06:38] Speaker 04:
Yes, Your Honor, but that goes to a different question, whether the official properly considered everything he needed in order to ratify.

[00:06:45] Speaker 04:
This is about whether there was the intent to ratify in the first place.

[00:06:49] Speaker 04:
In all of those cases, whether the ratification itself or the circumstances around the ratification made clear that what the official was doing was ratifying in the face of an appointments clause problem.

[00:07:01] Speaker 04:
There was an official who was ratifying all that same official's prior actions before he or she had been properly appointed

[00:07:07] Speaker 04:
or some other context made absolutely clear what was being done and why.

[00:07:13] Speaker 04:
Here, you're talking about a ratification that is included in every single delegation document under agency rule and reflects no intent to ratify Appointments Clause violations.

[00:07:24] Speaker 04:
There's no reason.

[00:07:25] Speaker 03:
I didn't even understand that that was the argument you were making in your brief.

[00:07:28] Speaker 03:
So you're saying that somehow they didn't intend to ratify this rule, but some other category

[00:07:37] Speaker 04:
Yeah, well, yes.

[00:07:40] Speaker 04:
I think the best reading of the CAILA for Advocation is that it is a standard boilerplate provision curing any past actions in violation of the delegation document.

[00:07:52] Speaker 04:
And so that's what it's purporting to ratify and cure.

[00:07:55] Speaker 04:
There is no evidence whatsoever that that boilerplate language has anything to do with appointments clause violations that Caleb had in mind any appointments clause violations, much less this appointments clause violation.

[00:08:06] Speaker 04:
This is simply a case unlike any of this court has ever considered.

[00:08:10] Speaker 04:
If this kind of boilerplate language satisfies for ratification,

[00:08:14] Speaker 04:
then I submit that no Appointments Clause claim could survive because these documents are put out all the time.

[00:08:21] Speaker 04:
I believe FDA has put out a version of this two or three times since the deeming rule came out, and every one of those would prohibit judicial review of every single Appointments Clause violation that preceded it.

[00:08:35] Speaker 04:
And so that's the problem with the Kayla Fratrication.

[00:08:38] Speaker 04:
It's not that he didn't consider some factor that he should have or that he didn't provide enough detail.

[00:08:42] Speaker 04:
It's that there's neither any indication in the ratification itself or any of the circumstances surrounding it that he actually intended to ratify an appointments clause violation in this rule or any other.

[00:08:55] Speaker 03:
So what would support, your rule would be that the agency would have to say, well, there's an appointments clause problem here.

[00:09:05] Speaker 03:
And therefore, we're going to fix it?

[00:09:08] Speaker 04:
I think that would be a very easy case.

[00:09:11] Speaker 04:
There may be other problems with the ratification, but at least in that case, you would know that the ratification was intended to ratify in the face of an appointments clause challenge.

[00:09:19] Speaker 04:
But I think you could also get it from context.

[00:09:21] Speaker 04:
Many of the cases that you referenced earlier, it was clear what the official was doing.

[00:09:25] Speaker 04:
It was either a board that was improperly constituted,

[00:09:27] Speaker 04:
reconstituted in compliance with the Appointments Clause, and then ratified all of its own prior actions.

[00:09:33] Speaker 04:
Everyone understood what the official or the board was doing in that context.

[00:09:38] Speaker 04:
Whereas here, you're talking about true boilerplate.

[00:09:40] Speaker 04:
There's no reason the government can point to to think that what Caleb was doing here was trying to ratify this rule and cure its Appointments Clause violation.

[00:09:49] Speaker 03:
So here at the agency did both, belt and suspenders, both before the issue really emerged

[00:09:56] Speaker 03:
There was a ratification.

[00:09:57] Speaker 03:
You said, well, it didn't signal that the agency perceived that there was an appointments clause problem.

[00:10:05] Speaker 03:
And then once the agency did perceive, because suit had been filed, again, in a very detailed ratification, Commissioner Gottlieb ratified.

[00:10:15] Speaker 03:
And there you say,

[00:10:18] Speaker 03:
OK, that's a ratification.

[00:10:21] Speaker 03:
But you have a couple of arguments, I guess, that it was arbitrary and capricious because he should have started the rulemaking process over again and built a new record, given that there might be further evidence.

[00:10:35] Speaker 03:
That seems contrary to, I mean, we review rules on the record on which they were made.

[00:10:40] Speaker 03:
And so unless there's no ratification at all, they have to be able to look at it on the record.

[00:10:45] Speaker 03:
No?

[00:10:47] Speaker 04:
I disagree, Your Honor, because of the Appointments Clause violation, you have to discredit the original issuance of the rule.

[00:10:54] Speaker 04:
And you have to instead assume that the agency action would have been the ratification.

[00:10:59] Speaker 04:
Commissioner Gottlieb's ratification at the time that it was issued.

[00:11:03] Speaker 03:
And under the ratification that's a re rulemaking a ratification looks back at something that may have been defective and says, we are going to consider this this package this this closed universe and bolster it post hoc I mean this is sort of the nature of ratification.

[00:11:22] Speaker 03:
But I also gather that for you, a big difference between the Calif ratification and the Gottlieb ratification is because the Gottlieb ratification was, after the case was filed, that it's only mooting and not resolving the Appointments Clause issue on the merits?

[00:11:40] Speaker 04:
We think it's both, yes.

[00:11:41] Speaker 04:
There are reasons we argue that both ratifications fail under the law of ratification.

[00:11:47] Speaker 04:
Finish up on the last discussion on the Gottlieb ratification.

[00:11:51] Speaker 04:
This court has said that a rubber stamp will suffice when there are there's no reason to think that a rule would come out differently.

[00:11:57] Speaker 04:
If the agency to repeat the API process here we we've shown through the recent studies that are now before the agency and by reliance on Butte County.

[00:12:07] Speaker 04:
that that standard hasn't been satisfied.

[00:12:08] Speaker 04:
The agency simply can't show that it is inconceivable that a properly appointed official going through the rulemaking process would not result in a material change.

[00:12:18] Speaker 04:
But you're also right, Your Honor, that if the ratification were valid, that would only create a mootness issue.

[00:12:24] Speaker 04:
And here, it's a classic case of voluntary cessation.

[00:12:28] Speaker 04:
The agency has done nothing to ensure that this could not recur, that these sorts of constitutional violations might not resume.

[00:12:37] Speaker 04:
And for that reason, the court should reach the merits anyway.

[00:12:40] Speaker 04:
And I see that I'm in my rebuttal time, so unless there are further questions, I reserve the rest of my time.

[00:12:51] Speaker 01:
All right, Council for Appalachia.

[00:12:54] Speaker 02:
May it please the court, Lindsay Powell for FDA.

[00:12:57] Speaker 02:
What we're dealing with in this case is a belated challenge that plaintiffs are bringing, asserted more than a year and a half after the deeming rule was promulgated, to a rule that both the HHS secretary and the commissioner of FDA have time and again expressed their approval for, both in general statements and through the formal ratifications that we're talking about now.

[00:13:21] Speaker 02:
And to plaintiffs point about,

[00:13:24] Speaker 02:
The problem with ratification being that the agency can somehow avoid review and avoid correcting a lingering appointments clause problem through this mechanism that overlooks what it is that ratification accomplishes.

[00:13:37] Speaker 02:
Ratification is a remedy.

[00:13:38] Speaker 02:
And so when a question is raised about the validity of the signing official, the person taking the action,

[00:13:45] Speaker 00:
it's entirely appropriate and indeed commendable for an agency to ratify that action in order to cure any possible defect and so an agency at that point in the ratification recite at least i have reviewed the following and give a couple paragraphs of why they're satisfied to ratify

[00:14:07] Speaker 02:
So in here, the Gottlieb ratification did take that form.

[00:14:10] Speaker 02:
We don't think that that is necessary in every case.

[00:14:12] Speaker 02:
Ratifications can take a variety, but Gottlieb did say that he had reviewed the record and explained why he was ratifying this.

[00:14:20] Speaker 00:
What about the first ratification?

[00:14:22] Speaker 00:
It wasn't in there, was it?

[00:14:23] Speaker ?:
No.

[00:14:24] Speaker 02:
No, it wasn't in there.

[00:14:25] Speaker 02:
That was a blanket ratification war of the type seen in Wilkes-Barre and Legitech.

[00:14:30] Speaker 02:
And I think particularly analogous is the ratification at issue in the Ninth Circuit's decision in CFPB versus Gordon.

[00:14:39] Speaker 02:
In all of these cases, the properly constituted board or properly appointed official asserted sort of across the board that it was ratifying all actions.

[00:14:48] Speaker 02:
during a particular period.

[00:14:50] Speaker 02:
And that is what Caleb was doing in the ratification here too.

[00:14:55] Speaker 02:
But we do know it has been mentioned from other evidence at the time that he was certainly aware of this rule in particular and emphatically agreed with it.

[00:15:04] Speaker 02:
So I know that it- I'm sorry, Ms.

[00:15:06] Speaker 03:
Powell, how do you respond to Mr. Wood's point that if this is sufficient, doesn't it render the appointments clause something of a dead letter that any

[00:15:17] Speaker 03:
agency can have individuals who really aren't officers that are duly appointed under the Constitution perform all kinds of significant governmental activity and then do periodic blanket ratifications.

[00:15:37] Speaker 03:
It feels concerning and somewhat hollow.

[00:15:43] Speaker 02:
So we, I mean, as an initial matter, we do continue to take that Ms.

[00:15:48] Speaker 02:
Cox was a validly appointed inferior officer who had authority to promulgate this rule at the time that she did.

[00:15:57] Speaker 00:
That wasn't the question you were asking.

[00:16:00] Speaker 02:
Yes, Your Honor.

[00:16:01] Speaker 02:
I am very happy to answer the question.

[00:16:03] Speaker 02:
I did just want to note that.

[00:16:08] Speaker 02:
Yes, Your Honor.

[00:16:10] Speaker 02:
I do not think it raises this concern.

[00:16:12] Speaker 02:
There's certainly full accountability being taken by the agency in the way that it has ratified this rule.

[00:16:19] Speaker 02:
And that is the purpose of the Appointments Clause.

[00:16:22] Speaker 02:
That is the principle that it safeguards that there is accountability.

[00:16:25] Speaker 01:
I understand that argument in this sense, that I thought Judge Pillard was raising a different question.

[00:16:34] Speaker 01:
In other words, the appointments clause limits who can do certain actions.

[00:16:43] Speaker 01:
And if others who don't have that authority take that action, and then years later, persons who have the authority purport to ratify, then what is left of the limitations in the appointments clause?

[00:17:03] Speaker 02:
This court's cases have never expressed this concern, notwithstanding the passage of time, as your honor notes.

[00:17:10] Speaker 02:
The one caveat to that, and this court has described it as a very narrow exception, applicable only to limited circumstances not presented here.

[00:17:18] Speaker 02:
But that's the situation we see in Landry, where you had

[00:17:23] Speaker 02:
like a recommending entity whose decision was not a decision at all, but subject by statute to further review by a deciding official.

[00:17:32] Speaker 02:
And there the court found itself in a sort of catch-22 where it couldn't even decide the question about whether the entity making the recommendation was an officer without sort of prejudging ratification.

[00:17:45] Speaker 02:
But in Getty's, the court specifically said that was limited.

[00:17:48] Speaker 01:
That was a very limited exception.

[00:17:51] Speaker 02:
Yes.

[00:17:51] Speaker 01:
All right, so here we're not in that area.

[00:17:57] Speaker 02:
Yes, Your Honor.

[00:17:58] Speaker 03:
So just to be clear on that, the catch-22 is because in order to come before a court, the kind of claimant raised in Landry would have to first exhaust and go through the commission itself, and therefore be ratified, and therefore one could never get at the underlying

[00:18:20] Speaker 03:
Appointments Clause problem.

[00:18:21] Speaker 02:
Yes, by statutes.

[00:18:23] Speaker 03:
It was built in.

[00:18:23] Speaker 03:
It was automatic that there would be ratification.

[00:18:25] Speaker 03:
Whereas here, although the FDA has chosen to and might choose to have a rule of periodic ratification, it's not tied to the challenge itself in the same way that the door is open and then it's closed before one can access it.

[00:18:44] Speaker 03:
Yes, Your Honor.

[00:18:45] Speaker 03:
That's correct.

[00:18:45] Speaker 01:
I assume you were familiar with that.

[00:18:47] Speaker 01:
So the question here, though, is

[00:18:49] Speaker 01:
Council argues that if Klotz did not have the authority, if Caleb had no intent to ratify appointment clause violations, then we're at Commissioner Gottlieb.

[00:19:10] Speaker 01:
And you have to rely on that.

[00:19:12] Speaker 01:
And what is your response to

[00:19:17] Speaker 01:
The argument, counsel has admitted they never raised this post-filing of the complaint.

[00:19:21] Speaker 01:
So that argument is not before us, or that challenge is not before us.

[00:19:26] Speaker 01:
But his other concerns about Commissioner Gottlieb's ratification is what I thought my question was getting at.

[00:19:35] Speaker 01:
And the way the brief is written for the FDA, I realize you just cite our cases and say, we've approved everything.

[00:19:42] Speaker 01:
But the facts are different, and that's what the appellant is arguing.

[00:19:48] Speaker 02:
I take setting aside the time in question, which, as you know, is forfeited and is also foreclosed by this court's decisions.

[00:19:54] Speaker 02:
I understand that the only other challenge to the validity of the Gottlieb ratification to be considered new evidence.

[00:20:03] Speaker 02:
And that is also foreclosed by this court's decision.

[00:20:06] Speaker 02:
It is true here that we are in a rulemaking context rather than the enforcement context that you see in Legitech or with

[00:20:15] Speaker 02:
but the difference in context doesn't provide any basis for a difference in outcome here in both cases.

[00:20:22] Speaker 01:
Well, that's what you're saying, and I know we said it in two cases, but we actually don't know what is in those studies.

[00:20:31] Speaker 01:
And who knows?

[00:20:35] Speaker 01:
There isn't any suggestion here that the agency necessarily would come to the same conclusion even if he had looked at the studies.

[00:20:44] Speaker 02:
So I don't think the court needs to refer to this evidence, but there actually is a very strong basis for concluding that the agency would reach the same conclusion.

[00:20:54] Speaker 02:
What FDA said at the time was that even if... How do we know what is in those studies?

[00:21:03] Speaker 02:
Well, we are taking plaintiffs' contention at their word at this point that they're suggesting that there may be evidence that puts e-cigarettes in a more favorable light.

[00:21:15] Speaker 02:
But plaintiffs and others in the same position as they are have been making that argument since the comment period for the deeming rule.

[00:21:23] Speaker 02:
So this is actually not new in any sense.

[00:21:25] Speaker 01:
What I'm trying to understand about our precedent is in the two cases that are referenced,

[00:21:31] Speaker 01:
we have been very clear that the agency would reach the very same conclusion.

[00:21:40] Speaker 01:
And here, I gather now that FDA is willing to assume that Appellant's argument about the nature of those studies is such that it would put an entirely different light on its clients' products.

[00:21:55] Speaker 02:
No, Your Honor, we are positioned, and I'm sorry if I was unclear, these studies are more of the same.

[00:22:00] Speaker 02:
These studies do not bring anything new.

[00:22:03] Speaker 01:
And what FDA said in that council, but my question is, how do we know?

[00:22:08] Speaker 01:
And you said you were relying on what appellants council said.

[00:22:12] Speaker 01:
I just want to be clear.

[00:22:13] Speaker 01:
I don't see our court so far to have dealt with the question about if there is new evidence out there and the ratification comes much later.

[00:22:24] Speaker 01:
I thought your response was, well, the record closed two years earlier.

[00:22:29] Speaker 01:
So what the studies might say, even if they totally undermine the reasoning of the original deeming rule, it's all irrelevant.

[00:22:41] Speaker 02:
Yes.

[00:22:42] Speaker 02:
Yes, we do say that.

[00:22:43] Speaker 02:
The ratification is not a new rulemaking.

[00:22:47] Speaker 02:
It is a look back at what would not look back needs to happen on the record as it was compiled.

[00:22:53] Speaker 02:
So FDA undertook a very robust rulemaking process here.

[00:22:57] Speaker 02:
accepting comment, extending that comment period, considering there were over 130,000 comments here.

[00:23:04] Speaker 02:
And that is the rulemaking record that we have.

[00:23:06] Speaker 02:
That's what Commissioner Gottlieb looked at, and that's entirely appropriate.

[00:23:09] Speaker 02:
And that is what this court's precedents say, that a ratification is not a new

[00:23:15] Speaker 02:
agency proceeding.

[00:23:16] Speaker 02:
It's a look back.

[00:23:17] Speaker 02:
It's a principal looking back at the conduct of its agent.

[00:23:20] Speaker 02:
Typically, occasionally it is the same official.

[00:23:22] Speaker 02:
That's not what we have here, but looking back at what its agent did and expressing approval with knowledge about the thing that was done at the time.

[00:23:29] Speaker 02:
So absolutely, your honor is correct that our argument is that the record was closed.

[00:23:35] Speaker 02:
That's the record we have.

[00:23:37] Speaker 02:
We do make the further point that- Just very briefly put,

[00:23:41] Speaker 00:
Do you concede the Council for the opposing party was correct that ordinarily a ratification after the issue is joined is not a valid ratification?

[00:23:55] Speaker 02:
No, I don't.

[00:23:56] Speaker 02:
I don't agree with that.

[00:23:59] Speaker 00:
Okay.

[00:24:00] Speaker 00:
Is not there a law of agency to that effect?

[00:24:04] Speaker 00:
Is there not?

[00:24:05] Speaker 02:
This court's decisions have repeatedly honored ratification and found it sufficient to remedy an alleged violation, even when it is brought after, you know, in the course of proceedings.

[00:24:17] Speaker 02:
So we see that in Legitech.

[00:24:19] Speaker 00:
Which case is that in?

[00:24:21] Speaker 02:
That's in Legitech, that's in Wilkes-Barre.

[00:24:23] Speaker 02:
In both cases, we had ongoing enforcement proceedings at the time that the ratification occurred.

[00:24:29] Speaker 02:
And in Getty's, the issue wasn't decided fully, but there was a rulemaking, a final rule that was promulgated by an officer, the validity of whose appointment was in question.

[00:24:41] Speaker 02:
While the case was on appeal, the attorney general ratified that final rule, and that was treated as resolving the matter, notably on the merits, not as mooting the case, but resolving it on the merits.

[00:24:52] Speaker 02:
And that's also stated in the court's other cases.

[00:24:58] Speaker 02:
With respect to the Caleb ratification, to the point that the ratification is somehow improper because or insufficient because it wasn't done for the express purpose of curing a particular type of problem, there's nothing in the case of cystic suggests that the validity of a ratification turns on whether the ratifier had authority, knowledge, and intent and not

[00:25:21] Speaker 02:
And that intent is intent to approve the thing done, not intent to correct a particular problem with the thing done.

[00:25:28] Speaker 02:
There's no case to suggest that it needed to be with reference to an alleged appointments clause problem at that time.

[00:25:35] Speaker 03:
You talk a little bit about the voluntary cessation exception and why if you're wrong about ratification during

[00:25:50] Speaker 03:
the dispute, resolving the merits rather than mooting the claim.

[00:25:54] Speaker 03:
If you're wrong about that, what would your position be on whether the appellants have reason to be concerned that the conduct would recur?

[00:26:05] Speaker 02:
Yes, Your Honor.

[00:26:06] Speaker 02:
So with voluntary cessation, it's important to be clear about what it is that we're worried about recurring.

[00:26:12] Speaker 02:
And the wrong that has to plausibly recur is the wrong two plaintiffs.

[00:26:19] Speaker 02:
And so here, we have a valid ratification of the deeming rule.

[00:26:23] Speaker 02:
That ratification can't be undone.

[00:26:27] Speaker 02:
So the Appointments Clause defect alleged with respect to that rule is now cured.

[00:26:33] Speaker 02:
if it were thought that FDA might in the future with respect to future rules, you know, undertake a similar signing by Ms.

[00:26:44] Speaker 02:
Cox, it's not clear that that would cause any harm to plaintiffs.

[00:26:47] Speaker 02:
It's not as though they're affected by every single rule.

[00:26:49] Speaker 02:
I do want to note

[00:26:50] Speaker 02:
So Ms.

[00:26:52] Speaker 02:
Cox's authority was always shared by the commissioner and the secretary.

[00:26:55] Speaker 02:
It was delegated to her by them.

[00:26:57] Speaker 02:
And it has recently been revoked.

[00:26:59] Speaker 02:
So as of September 15th, the secretary has announced that he will be signing all rules coming out of the department.

[00:27:07] Speaker 02:
So I think as a factual matter, that may also bear on plaintiff's mootness argument here.

[00:27:14] Speaker 02:
But even without that, there's no reason to think that any future wrong

[00:27:20] Speaker 02:
Would actually injure them in a relevant sense.

[00:27:23] Speaker 02:
So as to You know, make that doctrine applicable.

[00:27:27] Speaker 03:
You're saying it's almost a lion's problem there with raising the notion that the voluntary cessation creates a risk of harm to them.

[00:27:37] Speaker 02:
Yes.

[00:27:37] Speaker 02:
Yes, Your Honor.

[00:27:39] Speaker 02:
That's correct.

[00:27:40] Speaker 02:
And I think that the Secretary's memo, as recently issued, does again underscore the framework within which Ms.

[00:27:49] Speaker 02:
Cucks was always operating.

[00:27:51] Speaker 02:
She emphatically was an inferior officer at the time.

[00:27:54] Speaker 02:
She could always be removed with very little showing or reassigned by the commissioner or HHS.

[00:28:02] Speaker 02:
And as recently happened, her authority could always be revoked simply by

[00:28:06] Speaker 02:
pending the delegation.

[00:28:07] Speaker 02:
And so that that authority is now with the secretary.

[00:28:15] Speaker 02:
If there are no further questions, we ask that you affirm Council for a pillow.

[00:28:31] Speaker 04:
Thank you, your honor.

[00:28:32] Speaker 04:
This court should absolutely be concerned about FDA's whack-a-mole approach to the Appointments Clause.

[00:28:37] Speaker 04:
The bottom line is they argue that a boilerplate provision that is issued in every delegation document automatically invalidates any possible Appointments Clause or other challenge that could be made against anything the agency has ever done.

[00:28:52] Speaker 04:
And then their fallback argument is that an official can selectively ratify something that has been challenged in litigation while ignoring the evidence that's before him.

[00:29:02] Speaker 04:
And this means that the plaintiff must be denied relief.

[00:29:05] Speaker 04:
If that is upheld, there's little reason for any plaintiff, in my clients or any other person's shoes, to bring an appointments clause claim.

[00:29:14] Speaker 00:
At the end of the day... What would you say about the legit argument the council made?

[00:29:19] Speaker 04:
Legitech comes up in a couple of times, but I think you may be referring to the argument for Gottlieb.

[00:29:26] Speaker 04:
Legitech says that as a matter of discretion, the court will accept ratification in circumstances where it's clear the outcome at the end of the day would be the same, that the agency would just reissue the same rule or make the same decision in adjudication.

[00:29:40] Speaker 04:
Here, the government can't make that showing because of the studies we point to that are before the agency and under Butte County would have to be considered.

[00:29:48] Speaker 00:
We look beyond the record to find things like that.

[00:29:54] Speaker 00:
This is after the record closed that study occurred, wasn't it?

[00:29:57] Speaker 00:
Or it was reported, excuse me.

[00:30:00] Speaker 00:
The studies were before the ratification and that's where you get the... Well, let's say the record closed in the allegedly invalid decision of the interior official.

[00:30:11] Speaker 00:
The record at that point did not include the studies, did it?

[00:30:14] Speaker 00:
That's right.

[00:30:15] Speaker 00:
If we look beyond that record to determine what the decision, that the decision would have been the same.

[00:30:24] Speaker 04:
Yes.

[00:30:24] Speaker 04:
And I know if no president says anything to the contrary, we read the case.

[00:30:28] Speaker 00:
You know any of this says to your position?

[00:30:32] Speaker 00:
That's right.

[00:30:32] Speaker 00:
If there's no president to the contrary, is there any that supports you?

[00:30:37] Speaker 04:
I think the dicta in Legitech does support us by saying that the plaintiff there had pointed to nothing they would address in a new comment that might change the agency's mind.

[00:30:47] Speaker 04:
That's what distinguishes this case from that one.

[00:30:50] Speaker 04:
But more importantly, we see ratification as standing in the shoes of the invalid prior agency action.

[00:30:56] Speaker 04:
and therefore Butte County would apply to that ratification and any information before the official at the time would have had to be considered.

[00:31:04] Speaker 04:
Here it wasn't, therefore the official didn't have the authority to ratify.

[00:31:08] Speaker 04:
I see him out of my time.

[00:31:09] Speaker 04:
Thank you.

[00:31:10] Speaker 04:
You're sure firm.

[00:31:11] Speaker 01:
Thank you.

[00:31:11] Speaker 01:
Thank you, counsel.

[00:31:13] Speaker 01:
We'll take the case under advisement.