[00:00:00] Speaker 00:
Case number 21-7067, Angene Cannon deceased in a state of Angene Cannon by and through John Cannon and Francis Cannon, executors of the state of Angene Cannon versus Watermark Retirement Communities, Inc.

[00:00:14] Speaker 00:
et al.

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Appellants.

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Ms.

[00:00:16] Speaker 00:
Miller for Appellants.

[00:00:17] Speaker 00:
Mr. Becker for Appellees.

[00:00:25] Speaker 06:
Morning, Council.

[00:00:25] Speaker 06:
Ms.

[00:00:26] Speaker 06:
Miller, please proceed whenever you're ready.

[00:00:40] Speaker 05:
Thank you, Your Honor.

[00:00:42] Speaker 05:
May it please the court, Amy Miller, on behalf of Appellants, I'd like to reserve three minutes for rebuttal.

[00:00:47] Speaker 05:
The issues in this appeal of jurisdiction and immunity are both guided by the plain language of the PREP Act.

[00:00:54] Speaker 05:
I'll briefly address jurisdiction first and then turn to immunity.

[00:00:59] Speaker 05:
With respect to jurisdiction, I'd like to make a couple of points, especially following on Judge Pillard's point about the plain text.

[00:01:06] Speaker 05:
The first point really is the plain text of E-10.

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This is the basis for the appeal.

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E-1 through E-9 each contain the language limiting the scope to an action under subsection D, but E-10 very conspicuously does not.

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In fact, E10 not only omits that reference, it replaces it with reference to subsection A. Subsection A, of course, addresses immunity and not willful misconduct.

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It says covered persons shall be immune from suit and liability from all claims of loss related to the use or administration of a covered countermeasure.

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Ms.

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Miller?

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I don't think this was covered in the earlier case, but E1 through nine relate to the district court level and E10 relates to the court of appeals.

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Why would there be language in E10 about in an action under subsection D?

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I read the language as plainly referring to the appeal

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that can be brought here only if it's deliberate misconduct.

[00:02:28] Speaker 05:
So the fact that that language is omitted shows that Congress did make a choice not to include it in that section, and that is certainly very telling.

[00:02:39] Speaker 05:
But it is not the only time in the E section that it was contemplated by Congress that a suit may be initiated elsewhere.

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As counsel pointed out under E9 sanctions, it does say whenever a district court of the United States determines that there has been a violation of rule 11.

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That is another example where Congress, in our opinion, it's not sloppy drafting.

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It's actually intentional and contemplated that a suit may initiate somewhere other than the DDC.

[00:03:13] Speaker 04:
But I'm not sure that that helps you because I don't think

[00:03:18] Speaker 04:
that there's dispute that an action under the carve out in a subsection D action could take place in any district court in a country.

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And so if one were to confine E10 only to interlocutory appeals from orders in subsection D actions, you would still have them from an array of different district courts, no?

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Certainly, when any claim of loss is filed by a claimant, the PREP Act provides that the covered person shall be immune from suit and liability, regardless of where it's initiated.

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I mean, that's plain in subsection A. And Congress knew that claims of all shapes and sizes filed in district courts under color of state law and elsewhere may be filed

[00:04:15] Speaker 05:
But the point is that all claims of loss, there's immunity with respect to all claims of loss.

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Where are you reading the all claims of loss?

[00:04:24] Speaker 05:
In A1.

[00:04:25] Speaker 04:
Okay, so my reading, I mean, I think this may just be repeating Judge Henderson's question, but unlike subsections E1 to nine, which are addressed to the plaintiffs and what they have to do in framing up a claim under subsection D,

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Subsection E10 affords a procedure to defendants.

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And defendants' litigating position is the suit is not properly understood to be a suit under Subsection D and therefore should be treated as a suit under Subsection A. And so that's why it would, that's why E10 refers to immunity

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conferred by subsection A, that it's not, it kicks back in if the claim is not, if the point of the appeal is to say, no, no, we have this wrong.

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This is not a suit under subsection D. Ergo, it's a suit under A that's immune.

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So I'm just saying that that would be your opponent's argument, how we make sense of both the omission of reference

[00:05:35] Speaker 05:
to subsection D, which is in 1 through 9, and the adding of a reference to subsection A. Again, we go back to the fact that Congress intentionally included that phrase in every one of these.

[00:05:50] Speaker 05:
Yeah.

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And it would have been so easy and perhaps logical, if it were the intent, to say that to take jurisdiction of an interlocutory appeal from a proceeding under subsection D.

[00:06:03] Speaker 06:
It's also very telling that- But I thought, but I think the point is that it might not have made sense to say that because what the defendant would be saying is this is not a, this is properly considered is not a case under subsection D. I mean, that's your position.

[00:06:17] Speaker 04:
Well, if, if this were a case that had been filed in the three judge court as a, as a D action and you were representing your client and had, had an argument, no, this is not a misconduct.

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This is reverts back to being an ordinary A case.

[00:06:31] Speaker 06:
But the plaintiff, sorry, I got the parties misaligned, but right.

[00:06:34] Speaker 05:
Well, the subsection D procedures that initiate it properly in the DDC provide for emotion to dismiss or summary judgment.

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And there is a three judge panel, but it is only the issue of immunity on emotion to dismiss that presumably may be appealed to this circuit.

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It is not broader than that.

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It is a very narrow scope in our life.

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deal for this court to the denial of immunity, not statute of limitations, not whether they fail to exhaust administrative remedies, it's only immunity.

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And again, that's why it makes more sense with the rest of the act, particularly if under Appley's reading,

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the act would give greater rights and greater protections to defendants accused of willful misconduct.

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Has Watermark filed a protective appeal in the Third Circuit in the event that we don't have jurisdiction?

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They sought either a 1292B appeal or a Cohen collateral order appeal in the Third Circuit?

[00:07:47] Speaker 05:
No, we haven't.

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this interlocutory appeal was taken directly to this court within 30 days for the statute.

[00:07:54] Speaker 06:
Well, you wouldn't have to file a protective notice on it under collateral order.

[00:07:58] Speaker 06:
I take it, but under 1292 B you could still do that, right?

[00:08:02] Speaker 05:
Well, I believe so.

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But to answer the question, no, we have not done that.

[00:08:06] Speaker 06:
But yeah, but do you see a reason why you couldn't do that if you wanted to?

[00:08:10] Speaker 05:
We, we see the exclusive jurisdiction, um,

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for the mandatory jurisdiction language in E10 as directing the denial of immunity under subsection A under the PREP Act as this court would be the proper jurisdiction.

[00:08:28] Speaker 04:
But it doesn't say shall have jurisdiction only.

[00:08:30] Speaker 04:
And I'm not sure it's in your client's interest to read it that way, given that we haven't ruled yet.

[00:08:36] Speaker 05:
It does appear to be a mechanism in the statute that gives a covered person the option to pursue that here as early as possible.

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And that is certainly the option that we took.

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And suppose a defendant in your position misses the 30 days, just inadvertently misses the 30 days, and let's just take 1292B out of the equation for now.

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But the defendant still wants to take up

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the issue of immunity at the end of the case.

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And then it happens at the end of the case, like the case goes to a verdict in favor of the plaintiffs and the defendant wants to take up the issue of immunity.

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At that point, you don't dispute that in this case, for example, if this went forward and went all the way to that stage, that the immunity, the appeal at the end of the day would go to the third circuit.

[00:09:42] Speaker 05:
It would be.

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to take that up on appeal to the Third Circuit along with any other issues.

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The point of E10 is to give a covered person an early opportunity to pursue interlocutory appeal to this court for consistency and for immediacy to get an early answer, to have that issue.

[00:10:01] Speaker 06:
But there wouldn't be a consistency because, across results at least, because, or at least there wouldn't be guaranteed consistency across results because if it could be taken up to the Third Circuit at the end of the case,

[00:10:13] Speaker 06:
but it can be taken up to the DC circuit in the middle of the case, then that seems like an odd dynamic.

[00:10:20] Speaker 05:
Well, it is an immediate right of appeal.

[00:10:23] Speaker 05:
Congress anticipating that this would be the court, perhaps similar to appeals of administrative actions, where because of the expertise and having a central location, there could be consistency in results in reviewing denials of immunity as early as possible in these types of cases.

[00:10:42] Speaker 05:
It is our position that these would come from federal district court to this court.

[00:10:48] Speaker 06:
So your position is it doesn't cover state court?

[00:10:51] Speaker 05:
We're not advocating that today.

[00:10:54] Speaker 05:
We agree with Your Honor's statement earlier that there are perhaps federalism issues, abstention issues, including the Rucker-Feldman doctrine that would have to be considered in conjunction with E-10.

[00:11:09] Speaker 06:
Oh, but those aren't textual arguments.

[00:11:12] Speaker 06:
You're just saying that there'd be other things that kick in that might

[00:11:16] Speaker 05:
Certainly other statutes or other legal principles would be relevant.

[00:11:20] Speaker 06:
Can I just get clarification on E9?

[00:11:23] Speaker 06:
It does say whenever a district court of the United States determines that there's been a violation of rule 11 in an action under subsection D. So does E9 apply outside of an action under subsection D?

[00:11:39] Speaker 05:
You know, it appears to be confined to subsection D proceedings, but it does allow that a suit may have been initiated in the court.

[00:11:52] Speaker 06:
So you, oh, you, oh, you, you think that.

[00:11:56] Speaker 06:
The D action can only be brought in the in DDC, correct?

[00:12:00] Speaker 06:
But what he nine covers when it says whenever a district court I see is that it covers an action erroneously brought in a different district

[00:12:09] Speaker 05:
That's correct.

[00:12:10] Speaker 05:
And I'm drawing attention to that for the broader point that Congress anticipated both in E9 and in A1 that suits may be initiated in various different venues.

[00:12:22] Speaker 05:
The point is that all claims of loss have immunity for covered persons when there is a demonstration of a covered countermeasure.

[00:12:31] Speaker 04:
What about E6 where

[00:12:35] Speaker 04:
It's clearly limited to subsection D claims, and it talks about, in the event a covered person files an interlocutory appeal, and the denial of such motion, the discovery shall, no discovery shall be allowed.

[00:12:50] Speaker 04:
So it's staying discovery in a subsection D interlocutory appeal.

[00:12:57] Speaker 04:
It seems like that is,

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It's not a slam dunk, but it's a textual cross-reference to subsection D interlocutory appeal.

[00:13:08] Speaker 05:
Certainly the argument that subsection D proceedings that covered persons under those facts would have interlocutory appeal to this court as well.

[00:13:20] Speaker 05:
And to the extent E1 through E9 are talking about other aspects of those willful misconduct proceedings, it would be appropriate to reference that there may be an interlocutory.

[00:13:29] Speaker 04:
But I guess I'm pointing out that under your reading, you can take an E10 interlocutory appeal

[00:13:35] Speaker 04:
unrelated to subsection D claim, but instead at the threshold between does prep back community apply or is this not a prep back case at all?

[00:13:44] Speaker 04:
And in that situation, discovery would not be stayed by E6.

[00:13:54] Speaker 05:
Well, the way E10 is worded is that if there is a denial of immunity by a covered person,

[00:14:05] Speaker 05:
where the denial of immunity, the assertion of immunity is made under subsection A. That is enough to confer jurisdiction in this court for an immediate interlocutory review of that.

[00:14:18] Speaker 04:
But it's odd.

[00:14:19] Speaker 04:
Well, go ahead and finish your answer.

[00:14:21] Speaker 04:
I'm sorry, I just interrupted you.

[00:14:23] Speaker 05:
So it would not require, for example, a preliminary determination of whether the PrEP Act applies.

[00:14:31] Speaker 04:
Well, all I'm saying is that there's sort of two different

[00:14:35] Speaker 04:
boundaries where parties disagree about immunity.

[00:14:38] Speaker 04:
One is whether the PrEP Act applies at all, or if it's not a PrEP Act case, then the appeal could be this should be under the PrEP Act.

[00:14:50] Speaker 04:
You're representing your clients.

[00:14:52] Speaker 04:
Plaintiffs are saying, no, no, it shouldn't be because emergency use authorization wasn't met or whatever.

[00:14:58] Speaker 04:
Or the immunity question can happen as between a D case that's proceeding, or no, no, there's not enough pleading of the kind of willfulness that would allow a D case in a three-judge DDC court.

[00:15:15] Speaker 04:
So there's immunity under the PREP Act.

[00:15:19] Speaker 04:
So there's sort of these two different boundaries.

[00:15:20] Speaker 04:
And my understanding is that the first boundary, does the PREP Act apply or not, under your reading, there's an interlocutory appeal

[00:15:28] Speaker 04:
our court from a denial of that immunity, basically from a district court saying, that doesn't even apply here.

[00:15:34] Speaker 04:
And all I'm saying is the way you're reading the statute, in that case, when you're appealing from that order, discovery goes forward.

[00:15:44] Speaker 04:
Whereas when you're appealing from a district court saying the D claim can go ahead and you're saying, no, no, that should not go ahead.

[00:15:53] Speaker 04:
Discovery is state because E6 is expressly limited.

[00:15:58] Speaker 04:
to a claim under subsection D. Does that make sense?

[00:16:02] Speaker 04:
I know that was long-winded.

[00:16:03] Speaker 04:
Well, it does make sense.

[00:16:05] Speaker 05:
And I agree it's silent whether, if the action initiated in another district court, if discovery or other issues are also staged, it is more specific.

[00:16:16] Speaker 04:
And that seems anomalous to me, that Congress would not have provided for a discovery to stay there, but would have, in E, be provided for this interlocutory appeal.

[00:16:25] Speaker 05:
But in the context of E6,

[00:16:27] Speaker 05:
Congress really does get into the weeds with, you know, limits and timing of discovery and caps on damages and other things in E one through nine.

[00:16:36] Speaker 05:
It does make sense there that if we're going to talk about the amount of discovery and what the burden threshold is and the timing of it, it would be acceptable to go ahead and address that discovery is stayed during an interlocutory appeal.

[00:16:49] Speaker 05:
I don't believe that rules out that an interlocutory appeal can and should be taken from another district court just because proceeding where immunity was asserted was initiated there.

[00:17:07] Speaker 05:
Probably initiated their improper.

[00:17:10] Speaker 05:
But in many cases or in most cases, I would think, including ours, discovery is is stayed in the court is taking the district court is taking the position that for now it does not have jurisdiction of the case until the appeal is resolved here.

[00:17:28] Speaker 06:
Okay, let me make sure my colleagues don't have additional questions for you at this time, and we'll give you your rebuttal time.

[00:17:36] Speaker 06:
Um, and we'll hear from the police now.

[00:17:41] Speaker 06:
Thank you, Miss Miller.

[00:17:47] Speaker 06:
Mr Becker.

[00:17:58] Speaker 01:
Honors may please the court.

[00:17:59] Speaker 01:
Jake Becker on behalf of appellee plaintiffs and gene cannon in the estate of and gene cannon.

[00:18:05] Speaker 01:
The record is clear.

[00:18:07] Speaker 01:
complaint raises five separate causes of action, only one of which is solely based on the administration of hydroxychloroquine to Ms.

[00:18:13] Speaker 01:
Cannon.

[00:18:14] Speaker 01:
With the other four counts, plaintiff raises state claims of negligence based on 14 specific negligent actions and inactions by watermark, and the administration of hydroxychloroquine is only implicated by one of the 14.

[00:18:30] Speaker 01:
At the outset, it is noteworthy that appellants now seek this court to assert jurisdiction over both

[00:18:36] Speaker 01:
the claims related to hydroxychloroquine, and the unrelated state negligence claim.

[00:18:42] Speaker 01:
None of the aforementioned claims were brought under the PREP Act, nor do they implicate PREP Act immunity, any immunity provided by the PREP Act.

[00:18:50] Speaker 01:
In light of that, I'd like to address your honor's question about how Section E10 is meant more for defendants, rather 1 through 9 is meant for the plaintiff.

[00:19:01] Speaker 01:
That reading is precisely why E10 must be limited to cases brought

[00:19:06] Speaker 01:
under subsection D. E1 through 9, although it does include the prefatory language, is meant to dictate how you bring a claim under subsection D. Subsection 10, yes, does not have that prefatory language.

[00:19:21] Speaker 01:
However, it is meant so how a defendant can appeal and essentially transfer a case brought under D and say, no, this isn't willful misconduct.

[00:19:29] Speaker 01:
It should have been an A1 claim.

[00:19:31] Speaker 01:
So in that regard, the prefatory language included here

[00:19:34] Speaker 01:
would have only added more confusion and not less.

[00:19:37] Speaker 04:
Well, it could have been done clearly.

[00:19:39] Speaker 04:
I mean, you know, appeals of the District of Columbia Circuit shall have jurisdiction of an interlocutory appeal by a covered person taken within 30 days of an order in an action brought

[00:19:53] Speaker 04:
pursuant to subsection D, denying a motion to, you know, they could have, as Congress did with the other provisions, referred to the action of the plaintiffs in framing it and then given the defendant.

[00:20:06] Speaker 04:
But so they didn't do that.

[00:20:09] Speaker 04:
So I think the strongest argument, your biggest hurdle is the tax.

[00:20:14] Speaker 01:
I would agree, Your Honor, that the statute could certainly have been drafted more clearly.

[00:20:18] Speaker 01:
However, either interpretation

[00:20:21] Speaker 01:
To read it in the favor of the appellants, you would have to read in that it was applying to Section A1 claims as well, not limiting the Section D claims.

[00:20:29] Speaker 01:
And Your Honor, as pointed out before in referencing the Guam matter, is really instructive for how the court should read this when the preparatory language is missing.

[00:20:36] Speaker 01:
It should not be read in isolation.

[00:20:38] Speaker 01:
An effort to tear away the companions based on a negative implication falters in light of the other strong text around it.

[00:20:46] Speaker 01:
And even more importantly, I would refer to Justice Gorsuch

[00:20:49] Speaker 01:
writing for an opinion of the court of all eight justices, as Justice Kavanaugh was not participating in that decision, we've long stressed the significance of a statute's sequence of provision.

[00:20:59] Speaker 04:
Which case are you talking about?

[00:21:00] Speaker 01:
That would be New Prime, Inc.

[00:21:01] Speaker 01:
versus Olivia Area.

[00:21:02] Speaker 04:
I was going to say, I didn't think Justice Gorsuch wrote Guam.

[00:21:05] Speaker 01:
No, you're not.

[00:21:05] Speaker 01:
I believe that was Justice Thomas.

[00:21:06] Speaker 04:
Yeah.

[00:21:07] Speaker 01:
And in New Prime, there were sections one and two were describing what was being legislated, and then three and four were applying.

[00:21:14] Speaker 01:
That's precisely what's happening here.

[00:21:16] Speaker 01:
Subsection D is creating a new cause of action.

[00:21:18] Speaker 01:
In Congress, as they created this new cause of action, realizes, presumably, that they needed to provide the court with parameters for how that action should go.

[00:21:26] Speaker 01:
1 through 9 dictates how plaintiff brings the case, and E10 dictates how a defendant, if they thought it was improperly brought, can appeal.

[00:21:39] Speaker 06:
So on the point that you started with, which is that if Congress had used the same clause in an action under subsection D in 10, it would have been confusing.

[00:21:49] Speaker 06:
Sure, I completely follow that because I thought where that was going was there's a difference between an action that belongs under subsection D and an action that might have been brought under subsection D but actually turns out not to be one that belongs under subsection D. That is correct, Your Honor.

[00:22:05] Speaker 06:
And if that's the distinction, isn't that also true of all the other provisions, too, under E?

[00:22:10] Speaker 06:
In other words, E1 says, or a lot of the other provisions speak in terms of actions under subsection D.

[00:22:18] Speaker 06:
But even though in cases in which those provisions are applied, there's still going to be an underlying question as to whether a case is in fact one that belongs under subsection D. Except, Your Honor, in 1 through 9, that's dictating how a plaintiff would bring that case.

[00:22:38] Speaker 01:
So if you're bringing it under subsection E, you've already made that affirmative choice, where subsection E10 is for the defendant to say,

[00:22:48] Speaker 01:
that had improperly brought this claim.

[00:22:51] Speaker 01:
Plaintiffs under E-10 wouldn't claim that the claim was imprudently brought.

[00:22:57] Speaker 06:
I guess all I'm saying is then it seems to me, and I just may be missing it, but it seems to me that under one through nine, when it says action under subsection D, it's already meeting into an action that the plaintiff has chosen to bring under subsection D.

[00:23:13] Speaker 06:
And that's already read into it.

[00:23:16] Speaker 06:
And so if the same language were used in 10, then it would be the same thing that it's just an action that the plaintiffs chose to bring under D. Now, that might turn out to be something that the court decides was improper, but it's still all an action under subsection D means is not whether it's properly under D. It's just something that the plaintiffs chose to bring.

[00:23:39] Speaker 01:
And Your Honor, I understand your reading of that for that provision for E10.

[00:23:42] Speaker 01:
However, that would not be the case when read in a sequence.

[00:23:46] Speaker 01:
If you look at the provisions as a whole, one through 10, that reading would not come to light in the same manner.

[00:23:51] Speaker 01:
And in addition to the statutory structure of this provision, the court should also look at the untenable and unworkable result that you've already highlighted in your earlier questions if, in fact, this jurist E10 is to refer to all claims of immunity.

[00:24:07] Speaker 01:
It is your honors have noted.

[00:24:08] Speaker 01:
The jurisdiction will like a ping-pong ball be bouncing back and forth based on how the motion is granted and when the appeal is brought.

[00:24:17] Speaker 01:
Certainly Congress is not intending to put litigants in the untenable position where there could end up being conflicting case law.

[00:24:24] Speaker 01:
For example, in this matter, if the court were to find improperly, the prep act immunity is afforded to the appellant.

[00:24:31] Speaker 01:
However, in a companion case, the, um,

[00:24:35] Speaker 01:
party chooses to go through trial and then appeals to the third circuit, the third circuit could reach a separate result.

[00:24:40] Speaker 01:
And then future district court cases in Eastern district are going to be left in the position where no matter how they rule in a motion, they're going to be committing reversible error.

[00:24:49] Speaker 06:
It would, would there also be the circumstance that the defendant, if the defendant likes the law better in one circuit than the other and the defendant has the alternative of either taking an appeal, attempting an appeal under 1292 B or under each hand,

[00:25:05] Speaker 06:
then the defendant could figure out which court it wants to go to by choosing which procedural vehicle it's going to use.

[00:25:13] Speaker 01:
Certainly on our appellant's view of the statute will lead to foreign shopping.

[00:25:16] Speaker 01:
That is, that is undeniable.

[00:25:18] Speaker 06:
They would still have 1292B is not automatic by any stretch.

[00:25:20] Speaker 06:
So it's, you're still running a risk if you try to go by 1292B.

[00:25:25] Speaker 06:
I assume that you don't think 1292B is automatic because I assume you'd oppose it if the defendant saw it here.

[00:25:36] Speaker 04:
Is there any reason to think they couldn't have a Cohen collateral order appeal in the third?

[00:25:42] Speaker 01:
We would argue on the merits, Your Honor, that we would oppose that on the merits.

[00:25:46] Speaker 01:
We would not oppose it on the procedure.

[00:25:50] Speaker 06:
On the, you think there, I thought that in the previous argument that you would oppose the existence of a collateral order appeal, or am I wrong?

[00:26:00] Speaker 06:
Or maybe that's, maybe we shouldn't commit you to this,

[00:26:04] Speaker 06:
on do you think that there is a collateral order appeal?

[00:26:08] Speaker 06:
We would want to analyze that appeal before commenting on that specific appeal, Your Honor.

[00:26:16] Speaker 01:
In sum, as it relates to jurisdiction, the reading of E10 when read in sequence clearly indicates that it is only for Section D cases.

[00:26:26] Speaker 01:
However, if the court needs to look beyond the presumably ambiguous language due to the lack of a preparatory clause,

[00:26:33] Speaker 01:
In looking at the results, it's clearly your honor had indicated with your question going to lead to form shopping is going to put the district courts and litigants in an impossible position of being reversed, regardless of how it is brought or how it is.

[00:26:47] Speaker 04:
To the extent that you're relying on Guam.

[00:26:50] Speaker 04:
What's the anchor provision?

[00:26:52] Speaker 04:
So in Guam, the Supreme Court referred to an earlier anchor provision that colored the way it looked at the following provisions such that the lack of a specific reference to CERCLA in the case about seeking contribution where somebody has settled, the court said, well, we should understand that to be where they've settled CERCLA liability.

[00:27:15] Speaker 04:
What's the anchoring, the analogous anchoring provision here?

[00:27:17] Speaker 01:
Really the anchor, Your Honor, I would refer, as Judge Shravastava highlighted earlier today, that the title of Section E is procedures for suit.

[00:27:25] Speaker 01:
And that procedure for suit is immediately following subsection D. So Congress is putting into the statute a new cause of action, and then they are outlining the procedures for bringing a suit under that cause of action.

[00:27:37] Speaker 01:
So here Congress kind of tipped their hand in labeling these and sequencing these in the manner in which they did.

[00:27:44] Speaker 01:
It is meant to be read as a whole in context, going, this is our new cause of action, and this is how it is to be brought by plaintiffs.

[00:27:51] Speaker 01:
And if it's believed brought in properly by plaintiffs, this is how it is subject to an interlocking period.

[00:27:59] Speaker 01:
This court simply does not have jurisdiction over the pending matter.

[00:28:02] Speaker 01:
However, if this court does determine that a merits analysis is appropriate, it should find that Prep Act community does not attach the actions of Watermark and the record before it for two primary reasons.

[00:28:15] Speaker 01:
First, the record establishes that Watermark's use of hydroxychloroquine did not meet the HHS declaration on limits on distribution requirement.

[00:28:24] Speaker 01:
And second, Watermark's use of hydroxychloroquine does not fall within the population condition of the declaration.

[00:28:30] Speaker 01:
And thus, it cannot be deemed to be acting in accordance with the declaration.

[00:28:34] Speaker 04:
I thought you were really relying on the emergency use authorization.

[00:28:38] Speaker 04:
So when you refer to the declaration, are you reading it as incorporating the terms of the emergency use authorization?

[00:28:42] Speaker 01:
Yes, Your Honor.

[00:28:44] Speaker 04:
and where to walk us through that.

[00:28:45] Speaker 04:
I mean, I know you briefed it, but just walk us through the short version.

[00:28:49] Speaker 01:
So the declaration limits liability for covered countermeasures as they relate to either one, a federal agreement or contract, or two, recommended activity involving a covered countermeasure in accordance with a public health response.

[00:29:03] Speaker 01:
Here, the EAU was the public health response, and it gave very specific parameters for how hydroxychloroquine

[00:29:12] Speaker 01:
was to be used and administer.

[00:29:14] Speaker 01:
And specifically, there's no dispute that the FDA authorization upon which they would rely was for meant to treat COVID-19 patients only in a hospitalized setting who were ineligible for clinical trials and finally were 50 kilograms or more.

[00:29:30] Speaker 01:
Ms.

[00:29:30] Speaker 01:
Cannon was not hospitalized.

[00:29:32] Speaker 01:
She did not weigh more than 50 kilograms.

[00:29:34] Speaker 01:
And the record is devoid of any analysis of whether she would have been eligible for clinical trial.

[00:29:38] Speaker 04:
So is your understanding, I mean, in some ways, a nursing home is like a hospital.

[00:29:41] Speaker 04:
But is it your understanding that the threshold there is because the treatment itself was understood to have risks and limiting it to people who are in hospital and also weren't eligible for trials was sort of like, if this is really the last thing for someone who's seriously, seriously ill?

[00:29:58] Speaker 01:
Yes, your honor.

[00:29:59] Speaker 01:
And the parameters for why they gave it was this was meant to be a last resort.

[00:30:02] Speaker 01:
This was not meant to be given to asymptomatic patients like Ms.

[00:30:05] Speaker 01:
Cannon in a setting where if something goes wrong, they're ill-equipped to do so.

[00:30:10] Speaker 01:
And I anticipate, as they raise in their brief, they're going to claim access under the safe harbor provision on the merits argument.

[00:30:16] Speaker 01:
However, the safe harbor provision still requires that the individual be within the population identified in the declaration or authorization.

[00:30:24] Speaker 01:
Here, it is clear and indisputable

[00:30:27] Speaker 01:
but the fact before this court that Ms.

[00:30:29] Speaker 01:
Cannon fell well outside of the population requirement.

[00:30:33] Speaker 01:
And Your Honor, I hear your question to say, is there any way that could have seemed like a hospital?

[00:30:38] Speaker 01:
The declaration made clear in a hospitalized setting only.

[00:30:42] Speaker 01:
It didn't say hospitalized or other medical facility or to any person providing treatment.

[00:30:47] Speaker 01:
And it's noteworthy in appellant's brief that they said they were preparing, but they received guidance that

[00:30:53] Speaker 01:
nursing homes should not transfer patients to the hospital and should prepare for an influx of patients.

[00:30:58] Speaker 01:
They were already being told by the government that they are not a hospital and that they are going to have to keep their patients there.

[00:31:05] Speaker 04:
What about their argument that they were under a conflicting obligation when a doctor has prescribed a measure to administer it?

[00:31:14] Speaker 01:
I'm glad you raised that question because that actually goes to whether or not they were negligent, not to whether they would enjoy prep back immunity.

[00:31:21] Speaker 01:
However, as

[00:31:22] Speaker 01:
as that issue has been brought up, they are also under a state obligation to obtain informed consent from their patient.

[00:31:29] Speaker 01:
Here in this case, as the record clearly establishes, not only did they not receive informed consent, they affirmatively had consent withheld by Mr. Cannon for medical proxy for his mother and said, do not give my mother this medication.

[00:31:42] Speaker 01:
She has underlying heart conditions that will react poorly.

[00:31:45] Speaker 01:
Unfortunately, he was correct.

[00:31:47] Speaker 01:
Then the use of that medication led to cardiac arrest and ultimately her untimely death.

[00:31:52] Speaker 04:
What's your understanding if someone had claims about the willful abuse of a countermeasure that would fall within D and have to be filed within the three-judge court in DDC, and also had other state law claims like Ms.

[00:32:08] Speaker 04:
Cannon's claims of negligence and failure to care for her in the unrelated to covered countermeasures?

[00:32:15] Speaker 04:
How do you bring that to you?

[00:32:16] Speaker 04:
Just bring two different cases?

[00:32:18] Speaker 01:
Yeah, sure.

[00:32:19] Speaker 01:
There's nothing that would confer a jurisdiction

[00:32:21] Speaker 01:
over those state negligence claims to the DC Circuit Court of Appeals where that subsection D claim would happen.

[00:32:27] Speaker 04:
Or the DDC.

[00:32:28] Speaker 04:
And the first is that they couldn't be just pending jurisdiction under ordinary 1367.

[00:32:33] Speaker 01:
I believe that plaintiffs could possibly waive that issue.

[00:32:36] Speaker 01:
But the cleaner way to do it would be to sever the claims and treat them differently, which in the event that this court finds jurisdiction and finds that it was a willful misconduct claim,

[00:32:48] Speaker 01:
that I would suggest that the state court evidence claim should remain in the Eastern District.

[00:32:52] Speaker 01:
None of their claims should be severed and brought there.

[00:32:53] Speaker 01:
However, that's not the case here.

[00:32:55] Speaker 01:
This was not a welcome misconduct claim as the population requirement was not met.

[00:32:58] Speaker 02:
Thank you.

[00:33:00] Speaker 06:
Thank you, Mr. Becker.

[00:33:01] Speaker 06:
Ms.

[00:33:02] Speaker 06:
Miller, we'll give you three minutes for rebuttal.

[00:33:10] Speaker 05:
Moving to the issue of immunity, that issue was also guided by the plan

[00:33:14] Speaker 05:
of the Act in that this really was a classic example of a covered countermeasure under the Act.

[00:33:22] Speaker 05:
Hydroxychloroquine, which I'll call HCQ for purposes of the argument, was a covered countermeasure under two different prongs of the PREP Act, one it being a qualified epidemic and pandemic product, and the second that it by virtue of its emergency use authorization.

[00:33:40] Speaker 05:
the error in the district court's opinion.

[00:33:44] Speaker 04:
You only preserve the emergency use authorization claim.

[00:33:50] Speaker 04:
You didn't preserve below the other claim.

[00:33:54] Speaker 05:
We did raise the full definition of the covered countermeasure below in several places.

[00:34:01] Speaker 05:
Certainly we actually briefed it at length in the removal at JA 14, JA 15,

[00:34:08] Speaker 05:
Also, J.A.

[00:34:09] Speaker 05:
21, we discussed the covered countermeasure as both FDA approved and under emergency use.

[00:34:17] Speaker 05:
And the motion to dismiss at J.A.

[00:34:19] Speaker 05:
303 through 306, we talk about covered countermeasures being used as existing drugs, not new drugs that are approved for the first time under emergency use.

[00:34:33] Speaker 05:
And then we also raise it again in the answer

[00:34:37] Speaker 05:
Um, and then, uh, the district court, of course, squarely addressed it.

[00:34:42] Speaker 05:
Uh, it's in footnote three, um, of the J a five 69 where, and this is, this is the nature of the error.

[00:34:51] Speaker 05:
She noted that basically if it's, we're talking about a drug as opposed to a product that it needs to be considered under emergency use.

[00:35:00] Speaker 05:
But what the district court didn't do was look at the further definition of qualified pandemic and epidemic product, which under subsection seven makes clear it can be a product or a drug or a device.

[00:35:17] Speaker 05:
So H C Q in this case did.

[00:35:20] Speaker 05:
did constitute a covered countermeasure under two different prongs of the PREP Act, one of which emergency use, which had the restriction, the hospital setting, and then the other, it was already FDA approved and had been approved for decades and was used more to treat, more for symptom management.

[00:35:42] Speaker 04:
So you don't dispute that to the extent that you're relying on the declaration, one would have to follow the

[00:35:50] Speaker 04:
the emergency use, use authorization conditions.

[00:35:54] Speaker 05:
We absolutely dispute that the immunity, and this is another part of the district courts error in that the court determined that HCQ was not even a covered countermeasure because it did not comply or it was not used in accordance with the EUA.

[00:36:17] Speaker 05:
However,

[00:36:18] Speaker 05:
The fact of the authorization, the fact of the emergency use authorization under that definition of the covered countermeasure is enough to constitute a covered countermeasure.

[00:36:30] Speaker 05:
The proper question, which was not framed correctly in the opinion, is whether strict compliance with the use authorization gets you immunity.

[00:36:40] Speaker 05:
And for that, you need only look at the PREP Act and the declaration requirements, and was she in the population?

[00:36:48] Speaker 05:
The population was defined so broadly by the secretary for this particular COVID-19 emergency by stating that if the recipient received the covered countermeasure, essentially that's enough to put the individual in the population.

[00:37:07] Speaker 05:
I think what Council is raising is a separate element and that is the recommended activities portion of the limitations on distribution, which is in declaration and it's in the advisory opinion.

[00:37:24] Speaker 05:
But it's very clear under those documents that there's no strict compliance.

[00:37:30] Speaker 05:
It says this is not a strict compliance statute.

[00:37:33] Speaker 05:
It's not a strict compliance requirement.

[00:37:36] Speaker 05:
And the secretary even gave several examples of where errors were made.

[00:37:41] Speaker 05:
All guidelines were not followed.

[00:37:43] Speaker 05:
For example, in the advisory opinion that we cited in our brief, there's an example of a pharmacist who purchases and prescribes testing kits, and there's a lawsuit, and it turns out that the pharmacist had let their license lapse.

[00:38:05] Speaker 05:
That's a pretty egregious error.

[00:38:07] Speaker 05:
The secretary said in that case, the pharmacist does not lose liability.

[00:38:13] Speaker 05:
just because not all requirements were met.

[00:38:16] Speaker 05:
There is a concept of reasonable precautions.

[00:38:19] Speaker 05:
And here, the hospital requirement was not even in the regular FDA approval form of the covered countermeasure.

[00:38:30] Speaker 06:
So- Thank you, Ms.

[00:38:31] Speaker 06:
Miller.

[00:38:31] Speaker 06:
Let me just make sure my colleagues don't have additional questions for you.

[00:38:35] Speaker 05:
No.

[00:38:37] Speaker 06:
Thank you, counsel.

[00:38:38] Speaker 06:
Thank you.

[00:38:39] Speaker 06:
Thank you to both counsel.

[00:38:40] Speaker 06:
We'll take this case under submission.

[00:38:41] Speaker ?:
Thank you.