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Case No.

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20-5329.

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Inray Federal Bureau of Prisons Execution Protocol Cases.

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James H. Roan Jr.

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et al.

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Abalance vs. William P. Barr, Attorney General, et al.

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Mr. Dryluski for the Abalance.

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Mr. Meltzer.

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Ms.

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Batterson for the Appellees.

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Before you start, Mr. Driluski, I just want to thank all the attorneys for the expedition with which you've been filing briefs.

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We obviously wanted to be able to decide this in a timely manner, given pending executions.

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And we're very grateful for what we know has been night and weekend and long hours work on all of your end.

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You may proceed.

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Thank you, Your Honor.

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Good afternoon, and may it please the court.

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I'm Alex Driluski, pro bono counsel to appellant

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Corey Johnson, and today I'll be speaking on behalf of all appellants.

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And just to echo the thanks, we want to thank the court for scheduling this argument so quickly in this obviously enormously important case.

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I'd like to turn first, if I could, to the Food, Drug, and Cosmetic Act claim.

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The circumstances in which this case now sits, we submit, are extraordinary.

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The district court has held conclusively that defendants are executing prisoners in a way that violates federal law, and yet plaintiffs have been left with no remedy whatsoever for those proven violations and no way to prevent defendants from continuing to act contrary to law.

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This result was reached in error for the following reasons.

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First, under section 706 of the APA, plaintiffs were not required to show irreparable harm to prevent defendants' unlawful conduct.

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Second, even if plaintiffs were required to do so, the court's assessment of the evidence regarding irreparable harm was fundamentally flawed because it applied the wrong standard based on its misreading of the Supreme Court's per curiam decision in Lee.

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And third, regardless of the district court's assessment of the evidence, it independently aired by misconstruing the harm to plaintiffs based on defendants continuing violations.

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Turning first to section 706 of the APA, the district court ignored the plain language of this section, which provides in no uncertain terms that a reviewing court shall hold unlawful and set aside agency action not in accordance with the law, with no further requirement that plaintiffs show irreparable harm.

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Now, we know that when Congress wanted to require irreparable harm, it knew exactly how to do so.

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And we can look no further than Section 705 of the APA itself.

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But even accepting your statutory argument, Mr. Joylowewski, here you're asking for more than a declaration that the protocol is invalid.

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You're also

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seeking to enjoin action, contrary to the FDCA.

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You're seeking to enjoin the government from proceeding without a prescription in advance of the administration of the lethal injection.

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So don't we have to find irreparable harm?

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Don't we have to find bases to actually enjoin that action?

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So Judge Pillard, I think that the answer is no.

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And that's based on national mining.

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this court's decision by the late Judge Williams.

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In that case, what the court emphasized is both the APA shall set aside language, which was characterized as a command, but also then the relief that was awarded based on the agencies exceeding its power

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under the APA and under 706, the court awarded an injunction from the agency enforcing the set aside regulation, essentially an injunction, a nationwide injunction, and said critically that no showing of irreparable harm was necessary.

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We think the same reasoning applies here.

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You're not dealing with a preliminary injunction, the merits of which are still in dispute.

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We have conclusive and final judgment on this issue.

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Judge Chuckin ruled that the defendants here are violating the FDCA and thereby acting contrary to law.

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I'm sorry.

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Wasn't national mining decided before the Supreme Court's decision in eBay, which really has clarified a kind of a cross-cutting understanding that permanent injunctive relief depends on a finding

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of irreparable harm?

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It was before, Your Honor.

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We submit that eBay doesn't change the analysis.

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eBay was obviously not an APA case.

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It was a dispute arising out of the Patent Act.

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And the Patent Act itself had specific language in there about permissive injunctive relief.

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When you're dealing with relief under Section 706 of the APA, we submit national mining is still good law.

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And what it instructs is that an injunction can issue without a showing of irreparable harm once an unlawful act is determined finally and conclusively.

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But the government also says that their authority to conduct

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the execution by lethal injection doesn't derive from the protocol.

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So this isn't a case in which were we to say the protocol violates the Food, Drug, and Cosmetic Act, that they would lack authority.

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The authority derives from the Death Penalty Act.

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And indeed they've said they don't even need a protocol to proceed.

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So at bottom, there's a question whether

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the action needs to be enjoined or let me just say, put it this way, assuming that we disagree with you that the APA standing alone would support the kind of injunction that would give at least Mr. Melser's clients the relief that they seek.

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Tell us about the irreparable harm.

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I know in your briefs, you've argued that the kind of irreparable harm needed for the Eighth Amendment, needed for an injunction under the Eighth Amendment is different from the harm.

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In other words, that one could enjoin a violation of the Food, Drug, and Cosmetic Act based on irreparable harm that might not rise to the level of an Eighth Amendment violation.

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And just as a factual matter,

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I'm interested in what you're pointing to because in your briefing, you do seem to point to the same harm for both.

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And are there lesser other harms or is there a per se harm from failure to get a prescription or tell us more about that?

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Thank you, Judge.

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I will.

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And I'll move over to the irreparable harm point now on the assumption that we do need to show it.

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I will add before I move on that the suggestion that the defendants would continue to act in violation of the law, even if the protocol were held unlawful and set aside to us is both surprising and slightly disturbing.

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But moving on to having to show irreparable harm

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The district court got it wrong in assessing the evidence there because it placed much too much weight on the per curiam decision in Barr versus Lee.

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Now, that decision was decided in the context of a preliminary injunction, a last minute request to stay and execution

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And the court there held that in light of the competing evidence from the parties, the plaintiffs had not shown a substantial likelihood of success on the constitutional claim.

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And you know from looking at the opinion that the Supreme Court went to lengths in a backdrop section to show all of the reasons why it is, in the court's words, an exceedingly high bar to meet on the merits of a constitutional

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punishment claim, but here we're in a different posture and we're dealing with a different claim and a different analysis.

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The defendants have been found to be acting in violation of the FDCA.

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Now, assuming we have to show irreparable harm,

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The irreparable harm that we showed, and that the district court misconstrued, is that by not complying with the FDCA's prophylactic safeguards, and those are there specifically, the court in Beatty held, to ensure that lethal injection drugs

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are administered humanely and to minimize the risks of pain and suffering.

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By failing to comply with those safeguards, the plaintiffs here have been exposed to a risk of severe bodily harm.

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And it doesn't take a lot of digging to see where the district court's erroneous view of Lee infected the assessment of the evidence and the analysis here.

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First, you can look when the court assessed plaintiff's evidence,

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on the point of harm, it held that even if plaintiff's evidence might prove that pulmonary edema occurs in a prisoner while still conscious, that still would not be enough because the Supreme Court ruled in Lee that pentobarbital is not likely to cause an unconstitutional level of pain.

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In other words, in the court's view,

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There's no amount of evidence of pain that would be enough to show irreparable harm here.

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But that's not the likely standard.

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And we're not dealing with a constitutional level of pain.

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We're simply talking about irreparable harm arising from and relating to defendants continuing violations.

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But more importantly, the Supreme Court never said that.

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It simply held that the competing evidence before it, again, in the context of a last minute request to stay in execution,

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was insufficient to show a substantial likelihood of success on the constitutional claim.

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Right.

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So one of the harms you're pointing to in support of the FDCA claim is a sub-eighth amendment level of bodily harm potentially resulting from flash pulmonary edema.

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And my question is, is there any other harm

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that you're relying on.

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I mean, it struck me that if Bureau of Prisons officials were to make a determination that they were going to administer non-lethal drugs to non-death sentenced prisoners without complying with the FDCA, those prisoners sought to enjoin that conduct, they would likely

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be able to show, I mean, that would sound an irreparable harm.

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And I wonder if you agree or if you think there's some other harm other than the flash pulmonary edema that I understand has been the focus of the record and both of the claims in this case on which you're relying for injunctive relief just on the food, drug, and cosmetic claims.

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Thank you, Your Honor.

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I do agree with the hypothetical and think it applies squarely here.

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The harm is slightly different, I would frame it, than how it was just articulated by Your Honor.

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And to articulate it, you have to look at what the purpose of the FDCA is to begin with.

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It is a prophylactic statute that is meant to provide safeguards in the administration of drugs so that there is no unnecessary pain and suffering involved in that administration.

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And that holds true even in the lethal injection context.

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So here, by evading their statutory obligations under the FDCA, the defendants have exposed the plaintiffs to a severe risk of unnecessary pain and suffering in the context of their executions.

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And so while it's irreparable harm,

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Of course, can be the flash pulmonary edema.

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It is that increased exposure to that risk of severe bodily harm and and we put in the evidence on the record that there is very, very strong evidence that this pulmonary edema is severe bodily harm.

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of burning, suffocating, drowning in those in which it manifests while they are conscious.

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Can I just ask?

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I'm missing a step here, I think, in my mind.

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How does having a prescription written for compendibarbital address that?

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injury.

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Your assumption seems to be that it'll be written by a doctor who will say you can only use this if you first use an analgesic.

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But as we know, there are doctors who the government has its own witnesses.

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There are doctors who don't believe an analgesic is necessary.

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And so if they have a doctor who writes a prescription for pentobarbital and nothing else, nothing has happened.

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So I'm just not understanding how

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the prescription addresses the injury you're talking about?

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Sure, Your Honor.

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So it's beyond just an extra prescription for an analgesic or an opioid pre-dose.

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What the FDCA mandates and brings with it is the requirement that defendants seek out professional medical consultation, which would bring with it informed clinical judgment

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based on the most current science to ensure that the executions are administered in a way that mitigates risks of severe pain and suffering.

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Now, one result of that may be that a precaution is taken like a pre-dose injection of an opioid, but what it is is more than that.

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It is a process by which a medical assessment is made as to whether or not a particular execution is being done in a humane way.

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Now, the district court, we submit, failed to grapple with this point.

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How does the FDCA get to humane ways of execution?

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It gets to safe and effective and clinical supervision.

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But I don't know that the FDCA gets you a doctor enforcing humane execution standards.

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I don't know that's the same as safe and effective.

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I think the two are coextensive in these circumstances.

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So the court in Beatty, which this court affirmed in part, it talked about this.

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And it said that DCA ensures is that the drugs work for their intended purpose.

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And they work in a way that doesn't

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add to the risk of severe bodily harm.

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So in this case, it's not simply the goal to execute people.

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The goal, even defendants will agree, is to execute them in a way that doesn't add unnecessary pain and suffering.

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And looking at flash pulmonary edema, the evidence here is that it is extensive and severe.

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But that's your evidence.

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I mean, they clearly have competing evidence.

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And so if they get a prescription from

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one of their experts, or just a Bureau of Prisons doctor.

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And it says, just pent-a-barbatol.

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They will have complied with the FDCA, and your claim will be over.

[00:16:19] Speaker 00:
Well, then there's been, Your Honor, there's been no evidence that the defendants have ever done that.

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They don't seem willing to.

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They've only done it, but it doesn't, it doesn't, it doesn't, that remedy does not redress in any way the injury that you're asserting here.

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That's the gap that I'm missing.

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I think the injury is redressed, again, whether or not a pre-dose is prescribed at the end of the day.

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The point is the protection, the safeguard that's in place by the FDCA as a prophylactic statute is that medical process and assessment as to whether it's necessary or not.

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So we can speculate and the government can speculate.

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But that hasn't been the way you've been framing it.

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To me, I'm just not sure why the harm from the FDCA violation here is different from the harm from non-dentist sentence inmates who would want to get an injunction against beta blockers or insulin or what have you.

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But you do keep going back to the flash pulmonary edema.

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And you're right that the government will concede

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that they want to achieve humane execution, but they also argue that the Constitution doesn't guarantee a painless death.

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And so just struggling here to distinguish the threshold for injunction, and maybe this is unfair because we should also ask Mr. Meltzer some questions, but the threshold for injunction under the FPCA and how it really differs from the threshold under

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the Constitution?

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Yes, Your Honor.

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And in the constitutional level of pain, of course, the Constitution tolerates some level of pain.

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The standard is whether there's a super addition of pain on top of what is tolerable, and it's unnecessary.

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But here, in the context of irreparable harm for an FDCA violation,

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The district court itself recognized the possibility, even at the end of the day, that there's a possibility that these prisoners will suffer excruciating deaths.

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And so what the FDCA does is it puts in place those safeguards around the administration of Pento Barbatol

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that ensures that there is medical trained medical and clinic and clinical look at these executions before they happen each time to see if something is needed to to reduce the risk of that severe and unnecessary bodily pain that removing those safeguards alone is the irreparable harm here because you're putting these plaintiffs at risk without any of that clinical oversight let me let me just ask you

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Oh, go ahead.

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Go ahead.

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Oh, yeah.

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My question is maybe even prior to some of these points, which is I think some of the discussion highlights some of the difficulty of applying the FDCA at all to a drug that is being used for execution.

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I just wonder how we can read the FTCA to also apply the drugs being used in the context when you look at the text of the statute and the Supreme Court's analysis in Brown and Williamson.

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Thank you, Judge Rao.

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So this court has already ruled on the issue twice, that lethal injection drugs like pentobarbital are subject to the FDCA.

[00:20:08] Speaker 03:
Well, in the Cook case, the FDA conceded that the FDCA applied.

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So there wasn't really a full analysis on that question.

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Well, the court did look in Beatty below at the issue and assessed it as the drug at issue there, sodium thiopental, was a drug that was already regulated by the FDCA.

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And it doesn't lose its status or its definition as a drug.

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depending on its intended use.

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So a drug is a drug is a drug.

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And although it's used in the lethal injection context, it remains subject to the FDCA.

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And the policies, the core principles behind the FDCA continue to apply even in the lethal injection context.

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I think that's what

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distinguishes this case from the Brown and Williamson case, as Beatty recognized, even though you are using a lethal injection drug or a barbiturate as a lethal injection drug to bring about death, the policies behind the FDCA still come into bear to ensure that the drug is used as intended to ensure or to mitigate the risks of an inhumane death.

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And the court there analyzed this and said when a lethal injection drug isn't used properly, it doesn't function as intended, there is a risk that prisoners executed by it will suffer pain, will suffocate, and will unnecessarily experience pain.

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And so the policy behind the FDCA still applies even in the lethal injection context.

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We think that was a necessary predicate to then the Cook decision, which of course was, as your honor points out, somewhat assumed.

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But this court in a panel just last July that of course included Judge Pillard, followed Cook in denying the defendant's motion

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which was issued based on the district court's ruling that defendant's use of pentobarbital was likely violating the FDCA.

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And in doing so, the court relied on Cook and said that the defendant's position here conflicts with the necessary premise of Cook.

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We think that is just- And then the Supreme Court overturned that stay in July without any further explanation.

[00:22:46] Speaker 00:
It did, Your Honor.

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There was no reasoning in the order.

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No one knows exactly what the Supreme Court meant by that.

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The district court has declined the invitation to speculate as to what the Supreme Court meant by that.

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And we agree with that approach.

[00:23:04] Speaker 04:
Let me ask you to just give out your A-claiming claim just briefly.

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Putting aside the permanent injunction question,

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I take you to be arguing that at a minimum because even though injunctive really was, preliminary injunctive really was denied, that the case, the plaintiffs are entitled to have a factual determination, whether by cross motions for summary judgment or by a trial of the question that they've raised about

[00:23:41] Speaker 04:
flash pulmonary edema.

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Is that right?

[00:23:45] Speaker 00:
That's correct, Your Honor.

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The posture is critical here.

[00:23:49] Speaker 04:
Well, so the posture is critical, but the evidence, I mean, there was a lot of evidence put in on the pulmonary junction stage, and I guess the question is, is there

[00:24:03] Speaker 04:
And you had referred, I think, to Rule 52 and saying that the district court should have made facts.

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Are we, for all intents and purposes, actually at kind of a Rule 52 stage?

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I mean, has the district court already made

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of finding that based on the evidence that is the very same that would be made under Rule 56?

[00:24:29] Speaker 04:
Or is there more evidence that the plaintiffs would proffer or some procedural difference that it would make?

[00:24:40] Speaker 00:
So there are two answers, Your Honor.

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One, the Supreme Court's decision in Barr was a preliminary ruling.

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It was not a final adjudication on the merits.

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And of course, courts, even when they say that one party may not have met the substantial likelihood of success prong at the preliminary stage, have sometimes ruled that parties win on the merits down the road in a different

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Procedural posture and involving different evidence.

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And the second point is the evidence continues to evolve to answer your honor's question directly.

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The evidence has continued to evolve since our versus Lee there have been more executions and with every execution.

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that occurs, we get more evidence that pentobarbital, without any precautions put in place, is causing prisoners to feel the effects of flash pulmonary edema while still conscious.

[00:25:37] Speaker 05:
Can you clarify, have you got, because, have you got more evidence since the district courts ruling in September that the evidence does not show that they are likely to suffer because they're not likely to still be conscious?

[00:25:52] Speaker 00:
No, not more since then, Your Honor.

[00:25:54] Speaker 00:
But that's sort of one of the errors that we think the district court made here is that the district court looked at the new evidence.

[00:26:03] Speaker 00:
This was evidence from the execution of Lacroix and said, even if that is proof,

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that this prisoner suffered flash pulmonary edema while still conscious.

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That's not enough, given what the Supreme Court held in Barr versus Lee.

[00:26:20] Speaker 00:
And we think that is totally wrong, because what, in essence, the Court is saying is that no matter how much- She made that finding in a paragraph before she turned to what the Supreme Court has done.

[00:26:33] Speaker 05:
There she's just talking about all the evidence, the hearing she had with the expert witnesses.

[00:26:39] Speaker 05:
And she found that they are, the record does not support plaintiff's contention, I'm on page 39 here, that they're likely to suffer flash pulmonary edema while still conscious.

[00:26:51] Speaker 05:
The next paragraph is when she starts talking about the Supreme Court.

[00:26:54] Speaker 05:
So what I'm wondering is, if you don't,

[00:26:58] Speaker 05:
Is the point that you would get more evidence if you went past the pleading stage, or that you have more evidence, or is the evidence going to be the same, and it all turns on her next paragraph adding on the Supreme Court point?

[00:27:17] Speaker 00:
And Your Honor, I assume that you were reading from the Record 133.

[00:27:23] Speaker 00:
on page seven of the district court's order.

[00:27:26] Speaker 05:
I'm on page 39 of the September order.

[00:27:29] Speaker 00:
I see.

[00:27:30] Speaker 00:
In the November 3rd order, this is at 133 of the record.

[00:27:35] Speaker 00:
OK.

[00:27:37] Speaker 00:
The district court said, even assuming plaintiffs' new evidence.

[00:27:40] Speaker 05:
I'm sorry, which page are you on here?

[00:27:42] Speaker 00:
Sure, it's joint appendix 133.

[00:27:45] Speaker 05:
Sorry.

[00:27:47] Speaker 05:
What page of her opinion?

[00:27:48] Speaker 05:
Do you have the original opinion?

[00:27:50] Speaker 00:
It is page seven of the opinion in order.

[00:27:55] Speaker 05:
Thank you.

[00:27:57] Speaker 05:
Sorry.

[00:27:57] Speaker 00:
Well, at the top of page seven, it says, and I'm quoting, even assuming plaintiffs new evidence establishes that LaCroix suffered the effects of flash pulmonary edema while still conscious.

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Such evidence only confirms that the onset of flash pulmonary edema is possible upon the administration of Pento Barbatol.

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and then goes on to explain that what the plaintiffs need to do here is supply evidence that casts doubt on more than 100 executions that have happened in the past.

[00:28:29] Speaker 00:
And she grounds that ruling in her reading of Barr versus Lee.

[00:28:33] Speaker 00:
We think that was a fundamental error.

[00:28:35] Speaker 00:
And so what she's saying is if we have new executions that come out and they show, and they constitute proof that someone is suffering from flash pulmonary edema while still conscious,

[00:28:46] Speaker 00:
In her view, she believes the Supreme Court foreclosed that evidence for now and for all time.

[00:28:52] Speaker 00:
And we don't believe that that's overreaching.

[00:28:54] Speaker 05:
I'm asking a much more pedestrian question, and that is, would you have more?

[00:29:04] Speaker 05:
Do you have more?

[00:29:05] Speaker 05:
Would you have more?

[00:29:06] Speaker 05:
Your point is taken, but if you've given everything you have,

[00:29:15] Speaker 05:
And she's already said that's not enough, even apart from the Supreme Court ruling.

[00:29:21] Speaker 05:
She said it in September.

[00:29:22] Speaker 05:
That's why I'm asking, is there something since the September hearing or the September decision, the hearing that led to that?

[00:29:29] Speaker 05:
I can't keep track if there have been additional executions with evidence or you've gathered other experts or there's other evidence that you have or you think you would obtain by going forward with a case like

[00:29:41] Speaker 05:
you would if this wasn't something, if this was a normal constitutional litigation that wasn't caught up in the up and down and stays and death penalty cases.

[00:29:51] Speaker 04:
Or for cross-examination even.

[00:29:53] Speaker 00:
I think we would do a few things.

[00:29:54] Speaker 00:
We would certainly continue to gather more evidence from executions to continue to bolster our understanding that gets more precise and more certain with every execution that this is a problem.

[00:30:08] Speaker 00:
We would also cross, we would depose the experts that have been put up against us.

[00:30:13] Speaker 00:
We've never had the opportunity to get them in a deposition room.

[00:30:16] Speaker 00:
There has been some cross-examination, but it's a couple of hours of hearing over a weekend in an expedited fashion.

[00:30:23] Speaker 00:
We would want that evidence as well.

[00:30:25] Speaker 05:
So there is the answer to that.

[00:30:27] Speaker 05:
So that's what we would do again.

[00:30:30] Speaker 05:
Yes.

[00:30:31] Speaker 05:
Okay.

[00:30:31] Speaker 05:
All right.

[00:30:31] Speaker 05:
Have there been more state executions using just Penta-Barbatol this fall?

[00:30:37] Speaker 00:
I don't know the answer to that.

[00:30:38] Speaker 00:
I can try to find it out for you before the end of this argument.

[00:30:43] Speaker 05:
I just didn't know if that was another source of your following.

[00:30:46] Speaker 00:
OK.

[00:30:46] Speaker 00:
Another symptom of the problem, beyond saying that we needed to show evidence that cast a doubt on more than 100 executions carried out with Pento-Barbatol, was the district court also, despite recognizing some serious flaws in defendants to experts,

[00:31:12] Speaker 00:
the skewed view that the district court had as to its fact finding here and what evidence was necessary to show irreparable harm, again, in the context of the FDCA claims.

[00:31:23] Speaker 05:
OK, thank you.

[00:31:24] Speaker 05:
I think we have some other folks that's willing to talk.

[00:31:28] Speaker 05:
Do my colleagues have more questions at this point?

[00:31:29] Speaker 05:
We'll give you some time on your bottle.

[00:31:31] Speaker 00:
Thank you, Your Honor.

[00:31:32] Speaker 05:
Colleagues have more questions?

[00:31:34] Speaker 05:
OK, thanks.

[00:31:36] Speaker 03:
We'll let Mr. Pitzer speak to them.

[00:31:40] Speaker 05:
I'm sorry, Judge Wright, did you have a question?

[00:31:42] Speaker 03:
Uh, no, I did not.

[00:31:43] Speaker 03:
Thank you.

[00:31:44] Speaker 05:
Thanks.

[00:31:44] Speaker 05:
All right.

[00:31:45] Speaker 05:
Mr Meltzer.

[00:31:46] Speaker 05:
You're to talk about the same motion.

[00:31:48] Speaker 05:
Is that correct?

[00:31:49] Speaker 07:
Good afternoon, your honors.

[00:31:50] Speaker 07:
Jonathan Meltzer.

[00:31:51] Speaker 07:
I represent Brandon Bernard and I'm speaking on behalf of Mr Bernard and Orlando Hall.

[00:31:58] Speaker 07:
Uh, I would just like to, you know, um, rest on Mr Dry Lucy's discussion of the merits of the case.

[00:32:06] Speaker 07:
And I want to make one brief point about

[00:32:08] Speaker 07:
the stay standard made by the government.

[00:32:10] Speaker 07:
And then I will certainly address any questions that the court may have.

[00:32:14] Speaker 07:
The government suggests in footnote three of its opposition to the stay motion that the movements need to make a clear and indisputable showing of a right to relief in order to receive a stay in this case.

[00:32:29] Speaker 07:
And that is just not consistent with how the Supreme Court has treated

[00:32:36] Speaker 07:
challenges to lethal injection protocols in situations just like this one in three recent cases in Buckloo, in Glossop, and in Bays all in the last 12 years petitioners brought civil suits just like this one challenging a lethal injection protocol and in each case the Supreme Court granted a stay pending its

[00:32:57] Speaker 07:
disposition of the petitions for certiorari.

[00:33:01] Speaker 07:
And in none of those cases did the Supreme Court suggest that any higher showing was necessary, nor would it have made sense in those cases, because ultimately in all three, the petitioners lost on the merits of those cases.

[00:33:14] Speaker 07:
And so if petitioners had been required at the outset to make a clear and indisputable showing of a right to relief, the Supreme Court would have been in error in granting all three of those stays.

[00:33:24] Speaker 07:
It obviously did grant those stays and ultimately it did not rule for petitioners.

[00:33:30] Speaker 07:
But what that shows is that they were applying the typical stay standard from N10 and not the standard that the government suggests here.

[00:33:37] Speaker 07:
So what the government is in fact asking for here is a departure from standard Supreme Court practice on this type of stay motion.

[00:33:45] Speaker 07:
And we don't think that that's market.

[00:33:49] Speaker 05:
My colleagues have any questions?

[00:33:51] Speaker 04:
I wonder if you could address the question that I was also asking of your colleague.

[00:33:56] Speaker 04:
What, if any, difference you think there is between the kind of showing of a reprehensible injury that might support an injunction on the FDCA stash short claim as distinct from the constitutional claim?

[00:34:13] Speaker 07:
Uh, you know, we believe that, um, as Mr. Dry, Lucy said, the, um, showing of reprobable harm that we are the risk of harm that we would need to make here is just a slightly lower standard compared to the eighth amendment standard.

[00:34:28] Speaker 07:
And we would suggest that, um, essentially here.

[00:34:34] Speaker 07:
You know, the BOP has put forward experts, paid experts that have said that a sedative isn't necessary.

[00:34:40] Speaker 07:
But we would argue that an objective clinician would apply medical judgment on a clean slate.

[00:34:46] Speaker 07:
And given the risk of harm and the lack of any downside of giving the sedative, there's every reason to think that a sedative would be prescribed here.

[00:34:55] Speaker 07:
And so for that reason, we think.

[00:34:57] Speaker 05:
Is there something in the FDCA that tells them which doctors they have to go to to get this prescription?

[00:35:04] Speaker 07:
No, Your Honor, and certainly we would expect them to go to a doctor who would provide independent medical judgment on what is necessary.

[00:35:12] Speaker 05:
If they went to one of their BOP doctors, the BOP, you're a prison doctor.

[00:35:18] Speaker 05:
covering the facility where your clients are or where they're going to be executed.

[00:35:26] Speaker 05:
And that doctor issued a prescription, your FDA claim, FDCA claim would go away as long as there's a prescription.

[00:35:36] Speaker 07:
Well, what we think, as Mr. Chylusky said, what we believe is that that doctor would, you know, what we are entitled to is a doctor weighing whether or not a prescription for pentobarbital should be given in these circumstances and under what circumstances it would be given, whether the doctor would also prescribe a sedative along with it.

[00:35:58] Speaker 07:
And so if ultimately the BOP

[00:36:02] Speaker 07:
the position that you've hypothesized were to give that prescription without providing a sedative pursuant and lawfully under the FDCA.

[00:36:12] Speaker 07:
We think that is what we are doing, but we certainly believe that a medical doctor using independent judgment might well give that sedative, and we think that's precisely what we are entitled to here.

[00:36:22] Speaker 04:
I guess I'm having the same confusion that I had about the framing of this claim that I discussed with

[00:36:31] Speaker 04:
which is, you know, if I were an inmate with heart condition and I needed prescription

[00:36:38] Speaker 04:
I don't know what people get injected.

[00:36:40] Speaker 04:
And it had been routinely given to me by prescription.

[00:36:46] Speaker 04:
And then the prison said, we're just going to get this batch from a founding pharmacy.

[00:36:53] Speaker 04:
And we're going to have our nurses give it to you without prescription because of the drill.

[00:36:58] Speaker 04:
I wouldn't have to show any risk of flash pulmonary edema to get a junction against that.

[00:37:08] Speaker 04:
determine policy by the Bureau of Prisons, but I don't take that your argument and I'm sure that Ms.

[00:37:16] Speaker 04:
Patterson will tell me why that's an inadequate basis function, but it's not entirely apparent to me.

[00:37:27] Speaker 07:
No, I'm sorry.

[00:37:29] Speaker 05:
Before you answer, Mr. Mills, I apologize.

[00:37:31] Speaker 05:
I'm getting a lot of feedback.

[00:37:32] Speaker 05:
I don't know if other people are

[00:37:34] Speaker 05:
Um, former deputy, I don't, I noticed that Ms.

[00:37:36] Speaker 05:
Patterson is not needed.

[00:37:38] Speaker 05:
I don't know if that's part of the issue or not.

[00:37:41] Speaker 05:
Um, it looks like she's in a nice quiet place.

[00:37:44] Speaker 05:
Yeah, I know electronics.

[00:37:46] Speaker 05:
I don't, I'm not sure what else is going on.

[00:37:47] Speaker 05:
I'm just trying to, to like, so I can hear.

[00:37:49] Speaker 01:
Uh, Judge, Ms.

[00:37:50] Speaker 01:
Patterson is needed.

[00:37:51] Speaker 01:
She has a phone, uh, connection.

[00:37:53] Speaker 01:
Okay.

[00:37:53] Speaker 01:
Okay.

[00:37:55] Speaker 05:
I'm just trying to figure out what's causing all the feedback.

[00:37:57] Speaker 05:
I apologize.

[00:37:58] Speaker 07:
Your honor.

[00:37:58] Speaker 07:
I apologize.

[00:38:00] Speaker 07:
No, no, I apologize.

[00:38:01] Speaker 07:
It may be coming from me.

[00:38:02] Speaker 07:
I hope not, but it's certainly possible that I'm a source of feedback.

[00:38:05] Speaker 07:
But in any event, no, Judge Pillard, your question is certainly, you know,

[00:38:11] Speaker 07:
As, as with you, I'm interested to hear what Miss Patterson has to say in answer to that question.

[00:38:15] Speaker 07:
I certainly think that, uh, you know, the, the BOP is required under other circumstances to get a prescription for medication that is provided to prisoners.

[00:38:26] Speaker 07:
And so, um, you know, we certainly, you know, we believe that we have pointed what the harm is here of an SDCA violation of not allowing

[00:38:35] Speaker 07:
are not allowing a medical doctor to determine the circumstances under which pentobarbital would be prescribed to our clients.

[00:38:42] Speaker 07:
But, you know, there's obviously a more foundational question that you're asking here that we don't disagree with.

[00:38:48] Speaker 04:
And that, I mean, that would be satisfied by a BOP doctor who might judgment quite contrary, but that's the statutory obligation, is it not?

[00:39:02] Speaker 07:
That's exactly right.

[00:39:04] Speaker 07:
We certainly have a view of what we think that a BOP physician would do, but the obligation is for a BOP decision to make that independent judgment about what is required, and we believe that's the statutory obligation, and it should be carried out here.

[00:39:20] Speaker 04:
Just as if I wanted an insulin pump, but the doctor prescribing the insulin said, we're going to continue with your daily injection.

[00:39:29] Speaker 04:
That would comply with the FDCA, even if the policy I'm hypothesizing, which does away with it.

[00:39:35] Speaker 07:
That's exactly right.

[00:39:41] Speaker 05:
Are there any other questions?

[00:39:46] Speaker 05:
All right.

[00:39:46] Speaker 05:
Thank you very much, Mr. Meltzer.

[00:39:47] Speaker 05:
We'll hear from the government now.

[00:39:49] Speaker 03:
Thank you.

[00:39:53] Speaker 02:
I believe I've unmuted myself, but if you can't hear me, please let me know.

[00:39:57] Speaker 02:
I do want to note, I can't see Judge Rao.

[00:40:00] Speaker 02:
I don't know if there was an announcement I missed at the beginning, but I can see Judges Millett and Pillard, but not Judge Rao.

[00:40:07] Speaker 04:
She is present, and she is only on audio.

[00:40:10] Speaker 05:
OK.

[00:40:11] Speaker 05:
Thank you very much.

[00:40:13] Speaker 05:
And I apologize for causing feedback if I did it wrongly.

[00:40:17] Speaker 05:
Pardon?

[00:40:18] Speaker 05:
I apologize for accusing you of causing feedback.

[00:40:22] Speaker 02:
That's okay, Your Honor.

[00:40:25] Speaker 02:
You know, I'd like to start with the FDCA.

[00:40:28] Speaker 02:
And I'd like to first make the point that the Supreme Court's vacator of the first FDCA-based injunction in this case, in Perky, it was unexplained, but there are essentially two possibilities for the court's vacator.

[00:40:44] Speaker 02:
Either it agreed with the government on the merits that the FDCA simply does not apply

[00:40:50] Speaker 02:
drugs intended for use in lethal injection, or it considered the equities to warrant vacating the injunction that was entered.

[00:40:59] Speaker 02:
And either way, we think that that decision underscores the impropriety of reversing the district court's decision and deciding that an injunction based on any asserted FDCA violation is warranted here.

[00:41:15] Speaker 02:
Now as Judge Rowe referred to,

[00:41:18] Speaker 02:
There's sort of a threshold question before we even get to the existence of injunctive relief.

[00:41:23] Speaker 02:
And in fact, there are two threshold questions.

[00:41:26] Speaker 02:
That's first, whether the FDCA applies at all to lethal injection drug.

[00:41:32] Speaker 02:
And second, whether or not this type of APA suit can be brought to restrain violations of the FDCA.

[00:41:41] Speaker 02:
So I'd like to start actually with the second point and to course attention to 21 USC 337.

[00:41:48] Speaker 02:
which says that actions to enforce the provisions of or to restrain violations of the FDCA shall be in the name of the United States.

[00:42:00] Speaker 02:
Subsection B goes on to provide a very narrow carve out to that United States only rule for states in very specific circumstances.

[00:42:10] Speaker 02:
And we think that this is the sort of express congressional indicia

[00:42:16] Speaker 02:
of a statute that precludes, resorts the APA's default cause of action.

[00:42:23] Speaker 02:
You know, in cases like Block C Community Nutrition, the court said, we need to examine whether the particular class of plaintiffs who are attempting to use the APA to say something is wrong with a scheme, we need to see if Congress wanted that particular class of persons to be able to sue.

[00:42:42] Speaker 02:
And there, of course, it was implicit.

[00:42:45] Speaker 02:
The court found that in the, I believe it was the milk marketing scheme, because Congress had so carefully specified who could sue and who couldn't, the consumers who wanted to use the APA's cause of action there were out of luck.

[00:42:59] Speaker 02:
Now here- Was anybody allowed to sue there other than the government?

[00:43:04] Speaker 05:
Were there other private entities?

[00:43:07] Speaker 02:
Yes, there were other private entities who were allowed.

[00:43:09] Speaker 02:
But here we think in 337,

[00:43:12] Speaker 02:
the Supreme Court has very, I'm sorry, Congress has very clearly identified who can enforce the FDCA and it is the federal government or in very narrow exceptions, the state government.

[00:43:24] Speaker 05:
Are you aware of a situation where, and the point of the APA is that allows individuals to enforce, force the government to comply with law?

[00:43:37] Speaker 05:
which obviously isn't going to happen when the government's enforcing things.

[00:43:40] Speaker 05:
And so are you aware of a case where there was no alternative mechanism for private enforcement or other affected individuals, it may not necessarily be private, where affected individuals were barred from sitting under the APA for the federal government's noncompliance with the statute when the statute

[00:44:03] Speaker 05:
similarly to here, envision federal enforcement against other people, but it's clearly not against itself.

[00:44:11] Speaker 02:
Your Honor, I think most federal criminal violations work that way.

[00:44:15] Speaker 02:
It's not, you know, absent, you know, some sort of key handsuit under the False Claims Act.

[00:44:20] Speaker 02:
Generally, the public does not get to go and enforce federal criminal law, even if it thinks federal officials or federal agencies are violating that law.

[00:44:32] Speaker 02:
I think where Congress has reserved enforcement authority to the government, that is the type of preclusion under 701 of the APA that means that Congress has put to the side.

[00:44:45] Speaker 02:
And moreover, in Heckler v. Cheney, the Supreme Court found that the very enforcement provisions of the FDCA here at issue

[00:44:54] Speaker 02:
Well, this is not the 381 that was at issue in Cook.

[00:44:57] Speaker 02:
These are the underlying enforcement provisions.

[00:44:59] Speaker 05:
Well, they're not trying to sue to have you enforce the statute against somebody else.

[00:45:04] Speaker 05:
They're trying to sue to have you comply with the statute for people who are in your custody, who cannot fend for themselves.

[00:45:14] Speaker 05:
And your theory, thinking of Judge Pillard's hypothetical, the federal government said,

[00:45:24] Speaker 05:
just to have less paperwork.

[00:45:27] Speaker 05:
All drugs administered to BOP prisoners will be issued without prescriptions and without the superintendents of a doctor.

[00:45:40] Speaker 05:
It's enforced through the prescription process under the FDCA.

[00:45:45] Speaker 05:
And your position is nothing to be done about that unless the government sues itself.

[00:45:52] Speaker 02:
I think there might be other forms of suits available.

[00:45:56] Speaker 02:
What?

[00:45:56] Speaker 02:
I don't know specifically, because I know that there are statutes governing the ways in which prisoners can bring suit.

[00:46:05] Speaker 05:
But I do not think that's... No, no, but I'm talking about what the cause of action would be.

[00:46:10] Speaker 05:
Yes, there's the PLRA, but that's procedural.

[00:46:14] Speaker 05:
Is there another... Is your position here that they suit under the wrong statute?

[00:46:19] Speaker 05:
Is that what you're telling me?

[00:46:21] Speaker 02:
No, Your Honor.

[00:46:21] Speaker 02:
My position is that I don't know what other statutes might provide recourse or what limits Congress may have provided on such recourse.

[00:46:29] Speaker 05:
You're not aware of any other statute that would let them sue for the hypothetical.

[00:46:33] Speaker 05:
I'm borrowing Judge Pillard's here.

[00:46:35] Speaker 02:
I'm not, but I'm not saying that one doesn't exist.

[00:46:38] Speaker 02:
I'm saying I simply don't know.

[00:46:39] Speaker 02:
And I don't want to give the court an incorrect answer.

[00:46:42] Speaker 02:
But I think at crux, they could not use the FDCA

[00:46:46] Speaker 02:
to try or the APA to use the FDCA to restrain an FDCA violation.

[00:46:50] Speaker 05:
I should have thought that if there was another statute they should have used here that the government would have discovered that by now.

[00:46:56] Speaker 05:
I can't even conceive.

[00:46:57] Speaker 05:
I don't know of every statute in the books, but I see a lot of them and I can't conceive of what that other statute would be to make the government comply with the law.

[00:47:08] Speaker 02:
I'm not sure and I just don't want to get out ahead because this has not been written.

[00:47:12] Speaker 02:
Let's assume there's not another statute.

[00:47:14] Speaker 02:
And well, I'm wondering about the availability of Bivens liability.

[00:47:18] Speaker 02:
I do not know, Your Honor, and I don't want to spitball and give the court an incorrect answer.

[00:47:23] Speaker 02:
We can look into this.

[00:47:24] Speaker 05:
I guess I'm pretty sure, given the government's position on non-expansion of Bivens, that it's not going to invite an expansion to a statutory enforcement.

[00:47:34] Speaker 05:
In fact, I'm pretty sure Bivens law is clear that if there's an alternative enforcement scheme, you use that rather than implying a Bivens action.

[00:47:45] Speaker 02:
But I think that my point is that even in Judge Pillard's example, that if what you are trying to do is restrain a violation of the FDCA, that 337 reserves that to the government.

[00:48:00] Speaker 02:
And I am not opining on what other recourse may or may not be available or what other form it may take.

[00:48:06] Speaker 02:
But I do not think it could take the form of an APA suit saying you're violating the FDCA.

[00:48:13] Speaker 02:
Now, I do want to turn to the actual bases on which the district court rules here because, of course, the only things that have happened since August 27th when this court vacated an FDCA-based conjunction for failure to make factual findings on irreparable harm are that the district court decided that the evidence reasonable minds could differ.

[00:48:35] Speaker 02:
It held an evidentiary hearing to assess witness credibility.

[00:48:39] Speaker 02:
It listened to those witnesses.

[00:48:41] Speaker 02:
And then it issued factual findings that plaintiffs had not carried their burden of establishing the only irreparable harm they pointed to here, which is the risk of pulmonary edema while sensate.

[00:48:54] Speaker 02:
Now, there were two findings under their independent bases for the court's refusal to enter the requested injunction.

[00:49:02] Speaker 02:
The first is one that I believe Judge Pillard referred to earlier, and that is the disconnect between the asserted

[00:49:10] Speaker 02:
statutory violation, the lack of a prescription under the FDCA, and the relief that they are seeking.

[00:49:18] Speaker 02:
Penibarbital's effects do not vary based on whether or not they are accompanied by a prescription.

[00:49:23] Speaker 02:
And I think plaintiffs both misunderstand the FDCA and ignore the entire lack of evidence in the record when they suggest that the FDCA would somehow get them to a doctor prescribing a second drug.

[00:49:39] Speaker 02:
The FDCA does not require doctors to pair a prescription with tenor barbitol that's been compounded with any other drug or analgesic or opioid.

[00:49:50] Speaker 04:
And second, there's- I'll finish your second because I do want to hear that.

[00:49:55] Speaker 02:
There's sort of speculation about what doctors who take their view of what pulmonary edema does.

[00:50:02] Speaker 02:
There is nothing in the record to support the speculation about what doctors would do or wouldn't do.

[00:50:09] Speaker 02:
And so just getting them a remedy for the violation they say exists, just getting them a prescription, if that were possible, and the government does not think it is, does not remedy the only harm they've identified.

[00:50:23] Speaker 03:
They are looking to use the installation button and follow the instructions.

[00:50:29] Speaker 02:
I don't know what that is.

[00:50:31] Speaker 02:
I think I got the noise.

[00:50:33] Speaker 02:
I think that this underscores the degree to which they're trying to use the FDCA

[00:50:39] Speaker 02:
to reform execution protocols in a way that is far beyond anything the FDCA contemplates or dictates.

[00:50:48] Speaker 04:
Let me ask you a slightly different question, although it picks up from your discussion of the September ruling, the hearing, and the ruling.

[00:50:58] Speaker 04:
So on the Eighth Amendment, one of the, this is stepping away for a minute from the question about injunctive relief, and just talking about the factual dispute that the district court identified

[00:51:12] Speaker 04:
in the record and then said, you know, it's not a basis of irreparable harm.

[00:51:18] Speaker 04:
What's your view about whether and when it has been or will be fully resolved?

[00:51:27] Speaker 04:
Has it already been resolved in terms of, you know, she said there's conflicting evidence

[00:51:32] Speaker 04:
of whether Pento-Barbatol renders somebody insensate before it causes any kind of flash pulmonary edema.

[00:51:43] Speaker 04:
The government's witnesses say doesn't happen.

[00:51:45] Speaker 04:
The plaintiff's witness say yes, it does.

[00:51:49] Speaker 04:
And I didn't take the district judge to have resolved that, but rather to say, at least with respect to the Eighth Amendment claim, it doesn't rise to the level of

[00:52:02] Speaker 04:
of cruel and unusual, is it your position this has been resolved, that it doesn't need to be resolved because it's legally irrelevant, that it would ordinarily proceed to summary judgment and or trial, but we don't need that here because we effectively had that trial?

[00:52:24] Speaker 04:
I'm just, it's a little unclear to me given

[00:52:27] Speaker 04:
both the march of the emergency motions and the progress of the underlying case, what the government's position is about that question.

[00:52:39] Speaker 02:
So just to clarify the timeline here, at Docket 193, back in August, the district court granted the government's motion to dismiss the Eighth Amendment claims with respect to all plaintiffs except one, and I believe there are now two, who have individualized

[00:52:57] Speaker 02:
claims that are still being litigated in district court.

[00:53:01] Speaker 02:
The findings on the FDCA post-state the dismissal of the Eighth Amendment claims.

[00:53:07] Speaker 02:
So when the district court was weighing the evidence that the parties had put before her and trying to decide whether the plaintiffs had carried their burden of establishing that it was likely that they would actually experience the only harms they pointed to

[00:53:23] Speaker 02:
The court was only considering that in the context of an FDCA violation.

[00:53:28] Speaker 02:
Now, we think that the court properly looked to the Supreme Court's decision and lead not to resolve any factual questions.

[00:53:36] Speaker 02:
You know, the district court has just gone through and explained sort of in a blow-by-blow way what the evidence in the record was and who she sort of thought had or hadn't undermined too.

[00:53:46] Speaker 02:
And she finds repeatedly that the plaintiffs, under the standard they put forward, the likelihood standard,

[00:53:53] Speaker 02:
had not carried their burden.

[00:53:55] Speaker 02:
And then the district court says that it's looking to lead to decide sort of when it is appropriate, what warrants injunctive release.

[00:54:03] Speaker 02:
And we think the district court appropriately looked to the cues about when to use that equitable discretion, given that in Lee itself, the district, the Supreme Court had before the district court sort of preliminary assessment of the evidence before she heard from the witnesses before she had any

[00:54:22] Speaker 02:
or I'm sorry, before it had any evidence from Dr. Crowns, the government expert on which the court primarily pointed to.

[00:54:29] Speaker 02:
At that point, the court thought it was a virtual medical certainty that these harms would occur.

[00:54:40] Speaker 02:
And yet the court did not think injunctive relief was appropriate.

[00:54:45] Speaker 02:
And I want to negate any idea that this was because of a last minute request by the plaintiff.

[00:54:50] Speaker 02:
That request had actually been pending for weeks.

[00:54:52] Speaker 02:
It was because of last minute action by the district court.

[00:54:57] Speaker 02:
And by last minute, the court vacated the injunction even as to an execution that was six weeks longer than either Mr. Hall or Mr. Bernard's execution here.

[00:55:07] Speaker 02:
That is the type of last minute intervention that the court has said is inappropriate even in the face of then the district court's assessment that it was a virtual medical uncertainty

[00:55:18] Speaker 02:
that plaintiffs would experience pulmonary edema.

[00:55:21] Speaker 02:
Now, the only thing that's happened since then is the district court held a hearing and concluded that they hadn't made their case.

[00:55:29] Speaker 02:
And so the idea that injunctive relief, I'm sorry, Judge, you're trying to get in.

[00:55:35] Speaker 02:
The only things that have happened since the Supreme Court and this court have repeatedly made clear that injunctive relief, halting federal execution,

[00:55:46] Speaker 02:
The only thing that happened is they got adverse factual findings and they've gotten more process.

[00:55:51] Speaker 02:
We think that there is no basis, even on any of the claims in the appeal, for this court to direct, either to enter an injunction pending appeal or to direct the district court to enter the injunction that plaintiff seek.

[00:56:04] Speaker 02:
At most, even if they were, even if they're right, that there was some sort of error infecting the fact-finding process,

[00:56:12] Speaker 02:
at most that would leave this court with an absence of factual findings, which is exactly where it was on August 27 when it vacated an FDCA injunction for lack of factual findings.

[00:56:23] Speaker 02:
I'm sorry, I just cleared.

[00:56:25] Speaker 04:
In August, the district court basically took the Supreme Court's denial or vacature of preliminary injunctive relief

[00:56:37] Speaker 04:
and then said, it would thus seem contrary to leave for this court to enter judgment on those facts and find an Eighth Amendment violation.

[00:56:47] Speaker 04:
And so what I understand the plaintiffs to be saying here is that is taking a preliminary injunction holding to be determinative on the merits.

[00:57:02] Speaker 04:
And that does not seem correct to them.

[00:57:07] Speaker 04:
And your response to that is?

[00:57:10] Speaker 02:
Well, I want to distinguish.

[00:57:11] Speaker 02:
There were two Supreme Court vacanters of two different preliminary infections.

[00:57:17] Speaker 04:
The August determination, where the district court says that

[00:57:27] Speaker 04:
that she is looking at what the Supreme Court did in holding that the plaintiffs were not likely to succeed in Lee.

[00:57:36] Speaker 04:
And then she says, given what the Supreme Court did in Lee, it would seem contrary to that for this court, the district court, to enter judgment on those facts and find an answer.

[00:57:47] Speaker 02:
That's the Eighth Amendment claim, Your Honor.

[00:57:49] Speaker 02:
On the FDCA, what the district court did.

[00:57:52] Speaker 04:
I'm asking you about that because they think that, I mean, they have currently on the appeal challenges to both of those.

[00:58:01] Speaker 04:
holdings.

[00:58:01] Speaker 04:
And I think that as I take it, their challenge to the Eighth Amendment holding is basically the district court said, oh, you didn't get a preliminary injunction, you lose your case.

[00:58:13] Speaker 04:
And their position is, well, people fail to get preliminary injunctions and win their cases sometimes.

[00:58:19] Speaker 04:
When do we get our

[00:58:22] Speaker 04:
That's why I, when do we get our, you know, determination, whether on cross motions for semi-judgment or at a factual trial, which is why I was asking you, when do you think that happens or do you think that already happened?

[00:58:33] Speaker 02:
I do not think that already happened.

[00:58:37] Speaker 02:
The hearing that was held was on the FDCA after the eighth amendment claims had been dismissed, but I do not think they get that.

[00:58:44] Speaker 02:
And that is because the, what Lee reiterated and why we think the court appropriately looked to Lee

[00:58:50] Speaker 02:
Was that the eighth amendment poses and quote exceedingly high bar and under buck Lou Supreme Court latest you know fullest treatment of the eighth amendment.

[00:59:00] Speaker 02:
We think the type of pain that they have alleged here.

[00:59:03] Speaker 02:
Even if true, and I do want to make extremely clear that the government does not think that these inmates will experience pulmonary edema while sensei.

[00:59:12] Speaker 02:
And that is backed by expert testimony.

[00:59:14] Speaker 04:
But I am so I. And that's your position, absolutely.

[00:59:18] Speaker 04:
But so I think what you're saying is that this factual issue doesn't need to be resolved because it's legally irrelevant, because even assuming that the district court were to credit

[00:59:30] Speaker 04:
all the medical evidence that the plaintiffs have proffered in this case it is just not that what they've identified is not cognizable in your view under the eighth amendment.

[00:59:41] Speaker 02:
That's right your honor and we think that's why the district court's judgment dismissing at a 12b6 stage was proper.

[00:59:47] Speaker 02:
We think that they simply did not put forward enough.

[00:59:50] Speaker 02:
Moreover we think that they did not they failed to plead a known available alternative that significantly reduces

[00:59:58] Speaker 02:
any pain experienced, attendant to death, that the government has or lacks a legitimate penological reason for not adopting.

[01:00:07] Speaker 02:
They pointed to only two.

[01:00:08] Speaker 02:
They pointed to a two-drug regime, an opioid plus the pent-up orbital, and they pointed to the firing squad.

[01:00:18] Speaker 02:
There is not a single government that uses the two-drug regime that they want, and that is, as a matter of law, as the Supreme Court has made clear, a legitimate penological reason

[01:00:28] Speaker 02:
Not, not to use it.

[01:00:30] Speaker 02:
A state never has to or state or the federal government never has to be the first to test run an untried protocol every court to consider the I just wanted to go back to.

[01:00:44] Speaker 04:
So I had the question about the determination on the eighth amendment claim, which was the August determination.

[01:00:49] Speaker 04:
And it's been very helpful.

[01:00:50] Speaker 04:
You clarified for me that indeed it's a matter of law ruling that you take her to have made.

[01:00:57] Speaker 04:
So even looking at the pleadings, she's saying as a matter of law, if everything you're pleading is true, I can't allow that claim to proceed because it doesn't plead something that would constitute a matter of execution, Eighth Amendment violation.

[01:01:19] Speaker 02:
That's correct, Your Honor.

[01:01:21] Speaker 02:
And the district court was clear that it was crediting, sort of even crediting all of their evidence.

[01:01:27] Speaker 02:
This isn't enough.

[01:01:28] Speaker 02:
And we think that that was the correct application of the amendment law.

[01:01:32] Speaker 04:
Although this is part of what I'm having trouble with, and maybe I'm being really formalistic as to civil procedure, but

[01:01:40] Speaker 04:
The evidence was in for preliminary injunction, and then the underlying case was at the pleading stage.

[01:01:45] Speaker 04:
So the question is not really whether she credits her evidence, but whether she credits their allegations, and whether they could state a claim, a matter of execution, a matter of execution claim, and a non-frivolous claim.

[01:02:01] Speaker 04:
Is your position that the claim is, given the proceedings at the preliminary injunction stage, the claim is, in effect, frivolous?

[01:02:10] Speaker 02:
It's not that it's frivolous.

[01:02:11] Speaker 02:
Not every claim that fails to meet a 12b6 standard is frivolous, Your Honor.

[01:02:15] Speaker 02:
But, you know, there's a great deal of space between frivolity and, you know, fails to state a claim and fails to state a claim that could possibly get relief under the Iqbal standard.

[01:02:27] Speaker 02:
And we think the court was correct that this just did not state a claim.

[01:02:30] Speaker 02:
It wasn't enough.

[01:02:32] Speaker 04:
Okay, and on the FDCA claim, I think their position, so then a month later, or at least then next month, she- Can we stay on the Eighth Amendment for a minute?

[01:02:43] Speaker 05:
Or do you- Oh, yes, absolutely.

[01:02:45] Speaker 05:
On the Eighth Amendment, there's sort of this severity issue for pain, right?

[01:02:54] Speaker 05:
That's what I thought the district guard was saying, that whatever this pain is, it doesn't add up to

[01:02:59] Speaker 05:
It's something that violates the Eighth Amendment because the Eighth Amendment has a very high standard for pain.

[01:03:04] Speaker 05:
Is that how you understood it?

[01:03:06] Speaker 05:
Yes.

[01:03:07] Speaker 05:
Sorry.

[01:03:07] Speaker 02:
I'm having a little trouble hearing, but I think I agree that the district court properly recognized that the extent of pain alleged in the complaint did not meet the Eighth Amendment's high bar.

[01:03:22] Speaker 05:
Does gratuitous pain violate the Eighth Amendment?

[01:03:27] Speaker 05:
Even if it's not a...

[01:03:28] Speaker 05:
even if it's not a high bar.

[01:03:32] Speaker 02:
The Supreme Court has reserved the issue of whether or not there's an intent requirement.

[01:03:38] Speaker 02:
It's certainly that a state is somehow intending to add pain.

[01:03:42] Speaker 02:
The court has talked about super added pain, terror, or disgrace.

[01:03:46] Speaker 02:
And so if that's what you mean by gratuitous, the state is either intentionally or negligently adding pain, terror, or disgrace to a means of effectuating death

[01:03:58] Speaker 02:
then that is what the Eighth Amendment is aimed at.

[01:04:01] Speaker 02:
And of course.

[01:04:02] Speaker 02:
Right.

[01:04:02] Speaker 05:
So if there was pain, maybe it wouldn't be worse than hanging pain.

[01:04:08] Speaker 05:
Spincor talks about that sometimes.

[01:04:11] Speaker 05:
But it's not necessary to carry out the execution.

[01:04:17] Speaker 05:
It could be easily avoided.

[01:04:20] Speaker 05:
Or it's just an add-on.

[01:04:23] Speaker 05:
They don't need to do it anyway, but they choose to.

[01:04:25] Speaker 05:
So it's gratuitous.

[01:04:28] Speaker 05:
I'm not talking about the use of drug protocol, free drug protocols and drugs no longer being made.

[01:04:32] Speaker 05:
I'm just talking about, you know, they say we're looking for a vein, we're looking for a vein to put the drug into and they're going to stab around for a vein for five minutes and then we will insert it.

[01:04:49] Speaker 05:
All right, that's not super severe, terrible pain, but it's not necessary.

[01:04:55] Speaker 05:
You can get a phlebotomist that can stick that in the vein.

[01:04:58] Speaker 05:
the right vein the first time.

[01:04:59] Speaker 05:
You don't need to stab the guy in the arm for five minutes before you put the needle in the vein.

[01:05:04] Speaker 05:
So it's just super added on pain.

[01:05:06] Speaker 05:
That would violate the Eighth Amendment or not?

[01:05:09] Speaker 02:
I don't know, Your Honor.

[01:05:10] Speaker 02:
The Eighth Amendment has a very high bar, but I want to note that there are no allegations.

[01:05:14] Speaker 05:
What I'm asking is, does it have a high bar for pituitous pain?

[01:05:17] Speaker 05:
What if they punched him in the stomach to make him lay down?

[01:05:21] Speaker 05:
Let's make sure that we don't have to wrestle him.

[01:05:23] Speaker 05:
We're just going to punch him in the stomach, and then they always lay right back down, right down.

[01:05:27] Speaker 02:
Your Honor, I think that that type of super added pain could be on a different footing.

[01:05:32] Speaker 02:
And there are no allegations that the government is somehow super adding pain here.

[01:05:38] Speaker 02:
The allegation is that the method is inherently incapable.

[01:05:42] Speaker 05:
I think it's a question of understanding.

[01:05:43] Speaker 05:
I'm not sure they would agree.

[01:05:44] Speaker 05:
I think they would say, if I understand their argument, it's that it is wholly unnecessary.

[01:05:49] Speaker 05:
Now, I know you have experts.

[01:05:51] Speaker 05:
I'm not asking about that.

[01:05:52] Speaker 05:
I'm just trying to understand the legal test here.

[01:05:56] Speaker 05:
It's wholly unnecessary.

[01:05:58] Speaker 05:
to make people suffer this flash pulmonary edema.

[01:06:01] Speaker 05:
Even if you're right that it's not, it's bad, but it's not so bad that it violates the Eighth Amendment in its own right.

[01:06:11] Speaker 05:
But it's wholly unnecessary.

[01:06:15] Speaker 05:
Just give them a shot of morphine or something beforehand and it'll be gone.

[01:06:19] Speaker 05:
Something you have in the infirmary dispensary already.

[01:06:22] Speaker 05:
You know, there's chemo patients there.

[01:06:25] Speaker 05:
If you have painkillers, you have strong painkillers in your infirmary.

[01:06:28] Speaker 05:
All right, give them a shot of that and we will avoid this pain altogether.

[01:06:32] Speaker 02:
I think by that logic, there would have been an Eighth Amendment violation in Glossop and Baklu and any other case involving hanging, electrocution or firing squat.

[01:06:44] Speaker 02:
No, I don't know.

[01:06:45] Speaker 05:
That's just not true for hanging because there's nothing else you can do, right?

[01:06:49] Speaker 05:
Hanging was how they did it there.

[01:06:51] Speaker 05:
They didn't have pharmacological options that we do.

[01:06:54] Speaker 05:
now.

[01:06:55] Speaker 05:
It's a different time.

[01:06:57] Speaker 05:
And so the question is, simply, is gratuitous pain, even if it's not, so as more painful than hanging?

[01:07:08] Speaker 05:
It's not at that level.

[01:07:08] Speaker 05:
It's painful, but it's wholly unnecessary.

[01:07:12] Speaker 05:
Does that violate the Eighth Amendment or not?

[01:07:16] Speaker 02:
I don't think I just agree with how you're defining wholly unnecessary, Your Honor.

[01:07:20] Speaker 05:
And I think that it's.

[01:07:22] Speaker 05:
Sorry, I think it was a glitch here.

[01:07:24] Speaker 05:
I couldn't hear if you say.

[01:07:25] Speaker 02:
I disagree with how you're characterizing wholly unnecessary.

[01:07:31] Speaker 02:
And I think by this line of logic, the drug protocol.

[01:07:34] Speaker 05:
How am I characterizing wholly unnecessary?

[01:07:35] Speaker 05:
This is my question.

[01:07:36] Speaker 05:
All right, my question is, my hypothetical is, it's wholly unnecessary pain.

[01:07:42] Speaker 05:
You're a punch in the stomach because then we never have to worry about wrestling them down on the table.

[01:07:47] Speaker 05:
or stabbing around in the arm for five minutes before he put the needle in, it's wholly unnecessary pain.

[01:07:52] Speaker 05:
But it's not the type of severity of pain in the way it's felt that would in its own right violated if it were necessary.

[01:08:02] Speaker 05:
It's wholly unnecessary pain.

[01:08:06] Speaker 02:
I don't have an answer about what type of super added pain, terror, disgrace might qualify because as the Supreme Court explained,

[01:08:14] Speaker 02:
There has never been a method imposed by any government in the United States that attempts to super add pain, care, or disgrace.

[01:08:21] Speaker 02:
There has been an earnest desire to move to ever more humane types of execution.

[01:08:26] Speaker 02:
And that is why the Supreme Court has never invalidated a single execution method.

[01:08:32] Speaker 05:
You don't have a position on whether super added pain that's unnecessary to effect in the execution violates the eighth amendment.

[01:08:41] Speaker 05:
The government does not have a position on that.

[01:08:43] Speaker 02:
I think the Supreme Court

[01:08:44] Speaker 02:
I think the Supreme Court has indicated that super added pain.

[01:08:48] Speaker 02:
Well, the Eighth Amendment.

[01:08:49] Speaker 02:
But if you're asking me to sort of give examples or quantify of what that type of super added pain might look like, I can't because the Supreme Court has never identified.

[01:08:58] Speaker 05:
And you can, but you can come up with a hypothetical just like I did.

[01:09:03] Speaker 05:
I thought punching in the stomach was a safe hypothetical, but I guess not.

[01:09:07] Speaker 05:
The government believes it could do that.

[01:09:09] Speaker 02:
I am not agreeing, and I am certainly not conceding that we would think that that is inappropriate or constitutional.

[01:09:16] Speaker 02:
I am not taking a position on that question, Your Honor, because that is so far.

[01:09:19] Speaker 05:
So you're not agreeing that it's unconstitutional either?

[01:09:22] Speaker 02:
See, I am taking no position, Your Honor.

[01:09:24] Speaker 02:
We are so far from any of the allegations in this case.

[01:09:28] Speaker 02:
And if there were some sort of constitutional principle that required us to affirmatively eliminate any of the sort of necessary pain that attends death,

[01:09:38] Speaker 02:
we would have seen very different results.

[01:09:40] Speaker 02:
And in fact, the Supreme Court in bays very clearly said judges should not become sort of boards of inquiry tinkering with execution protocols that is not permissible under the eighth amendment.

[01:09:53] Speaker 05:
And of course you agree courts can get involved if we believe there's a violation of the eighth amendment.

[01:09:59] Speaker 05:
That's not a board of inquiry.

[01:10:01] Speaker 05:
And if a court was of the view that unnecessary gratuitous pain violates the Eighth Amendment, your Board of Inquiry point wouldn't be relevant, right?

[01:10:13] Speaker 02:
It would, but I think the threshold, my point is about the threshold.

[01:10:19] Speaker 02:
Your Honor, my point is that the Supreme Court's language about a Board of Inquiry indicates that there is a very high bar before courts should get involved.

[01:10:28] Speaker 02:
I'm not saying that any time a court

[01:10:30] Speaker 02:
might take action to restrain a violation of the Eighth Amendment, that that is a judicial board of inquiry.

[01:10:36] Speaker 02:
But I am saying that the Supreme Court has made clear that it is a high bar before courts get involved like that in changing the parameters of an execution method.

[01:10:45] Speaker 02:
And it is so far, so high in fact, that the Supreme Court has never authorized it.

[01:10:51] Speaker 04:
Let me ask you back about the

[01:10:56] Speaker 04:
DCA claim and the record, I asked you when we had an exchange about the Eighth Amendment and why it was that it was the government's position that the plaintiffs are not entitled to a factual determination on the merits on the harm relating to that claim.

[01:11:18] Speaker 04:
With respect to the to the FDCA claim, my understanding is that part of the plaintiff's appeal here is to argue that the district court erred in relying in sort of interchanging the Eighth Amendment and the FDCA harm and that in the September opinion, she basically said, you know, where goes the Eighth Amendment, so goes the FDCA, whereas

[01:11:46] Speaker 04:
the thresholds might be different and the harm that are material to a violation and to the entitlement to injunctive relief under the FDCA might be different.

[01:12:01] Speaker 04:
And that was a point that plaintiffs were arguing that she didn't appreciate.

[01:12:05] Speaker 04:
So I just wonder there, because it's not the same structure.

[01:12:10] Speaker 04:
You've been saying that there is this sort of threshold

[01:12:13] Speaker 04:
the non-painless but nonetheless not inhumane execution for purposes of the Eighth Amendment.

[01:12:20] Speaker 04:
That's not the inquiry under the FDCA.

[01:12:23] Speaker 04:
So is it not problematic that the district courts seem to be treating the cognizable harm under both of those as equivalent?

[01:12:33] Speaker 02:
I don't think that's what the district court did.

[01:12:34] Speaker 02:
I think that's very unfair to the district court's analysis.

[01:12:37] Speaker 02:
I'm looking at docket 261.

[01:12:42] Speaker 02:
I'm looking at, this is around J.A.

[01:12:45] Speaker 02:
120.

[01:12:45] Speaker 02:
We start there, page 36 of 261.

[01:12:49] Speaker 02:
And the district court goes through the evidence.

[01:12:52] Speaker 02:
The district court was not relying on Lee for any factual determinations.

[01:12:56] Speaker 02:
The district court made its own factual determinations.

[01:13:00] Speaker 02:
Then in light of those factual determinations, this is the September opinion.

[01:13:05] Speaker 02:
This is September 20.

[01:13:06] Speaker 02:
You're on page.

[01:13:09] Speaker 02:
So I'm starting at page 36.

[01:13:12] Speaker 02:
Right.

[01:13:14] Speaker 02:
And about halfway down, the court starts its analysis.

[01:13:17] Speaker 02:
It says the record contains conflicting evidence.

[01:13:20] Speaker 02:
And it runs through the different declarations from each of the sides, the competing evidence.

[01:13:27] Speaker 02:
It describes how the plaintiffs are relying on autopsy evidence.

[01:13:33] Speaker 02:
And then at the bottom of page 37, after considering the conflicting declaration, the court found that the question of whether an inmate will suffer a flash of pulmonary edema before becoming insensate was one on which reasonable minds could differ.

[01:13:45] Speaker 02:
That's an attempt to make credibility assessments.

[01:13:48] Speaker 02:
Goes on to explain it held an evidentiary hearing.

[01:13:51] Speaker 02:
It explains why Dr. Crown's testimony meant that the evidence plaintiffs relied on

[01:14:00] Speaker 02:
was not probative of the question.

[01:14:02] Speaker 02:
Dr. Crowns explained that autopsy evidence doesn't say anything about how quickly an inmate became insensate.

[01:14:10] Speaker 02:
Recall that the claim here is that an inmate will be unresponsive, so will appear unconscious, but actually sort of non-visibly be experiencing pain.

[01:14:24] Speaker 02:
And so the fight is when you actually become insensate.

[01:14:29] Speaker 02:
And so we had put in copious evidence showing that we thought that this claim that somehow pentobarbital would get to your lungs but not your brain, it would make you experience pulmonary edema without also rendering you unable to experience them, was simply wrong.

[01:14:46] Speaker 02:
And the district court concluded that they had not met their burden.

[01:14:52] Speaker 04:
After that, the district court... Right, the difficulty I think the plaintiffs are identifying is

[01:14:59] Speaker 04:
that she, in ruling on the FDCA claim, she says, for example, in the denial of the reconsideration order on page 133, she says, as the court has already explained, given Supreme Court precedent, it's not enough to warrant injunction relief, but there isn't Supreme Court precedent on the FDCA.

[01:15:22] Speaker 04:
point.

[01:15:24] Speaker 04:
And so she's really inverting here to Eighth Amendment inquiry when what the plaintiffs here are talking about is FDCA relief.

[01:15:38] Speaker 02:
And the district court at 133 said that sort of like the most that their evidence, their most recent autopsy evidence, which again, she had already explained in her prior order, why Dr. Crown's explanation

[01:15:52] Speaker 02:
had not been undermined.

[01:15:53] Speaker 02:
But that type of autopsy evidence doesn't speak to the question of when an inmate became sensate.

[01:15:58] Speaker 02:
And I think you have to read them in line of each other.

[01:16:01] Speaker 02:
But the district court, when it transitions to talking about lead, just as in the September order, is not talking about factual findings, it's talking about what warrants the exercise of equitable discretion, what warrants injunctive relief.

[01:16:16] Speaker 04:
Under the Eighth Amendment, which

[01:16:20] Speaker 04:
might differ, right?

[01:16:21] Speaker 04:
Or is it your view that there is no, I mean, I know your view is that the FDCA doesn't apply and that it can't be enforced, but assuming it did apply and that an APA claim is available, which I understand that's not where you are, but just to help us out.

[01:16:38] Speaker 04:
If it's available, is it your view that in order to show, in order to be entitled to injunctive relief under the FDCA,

[01:16:48] Speaker 04:
one would have to plead and ultimately prove harm that would violate the Eighth Amendment.

[01:17:00] Speaker 02:
I'm not sure I would put it that way, Your Honor, but I remember there are two remaining equitable factors.

[01:17:04] Speaker 02:
And I think that the balance of equities and the public interest.

[01:17:10] Speaker 02:
And here what plaintiffs are saying is that because of the failure of the prescription,

[01:17:17] Speaker 02:
they can grind to a halt all lethal injections in the country.

[01:17:21] Speaker 02:
And that, in fact, all lethal injections that have happened without a prescription, which is the vast majority of them, I think it's like 1,000, have been unlawful all along.

[01:17:30] Speaker 02:
And I think that as a matter of equitable factors and equitable discretion, it would be the tail wagging the dog to allow the FDCA to enter an injunction halting lethal injections where the Eighth Amendment couldn't.

[01:17:44] Speaker 02:
I think that it is appropriate to look at the Supreme Court guidance about when injunctive release is and is not available in the Eighth Amendment context in exercising a court's equitable discretion, even assuming an FDCA violation.

[01:18:00] Speaker 02:
And I want to again point out that even if this court disagreed with how the district court made a factual finding, that leaves us where we were on August 27th.

[01:18:10] Speaker 02:
It does not warrant the entry of an injunction.

[01:18:14] Speaker 04:
So you did mention in terms of the balance of equities in your briefing, the principal equity that you talked about was delay.

[01:18:29] Speaker 04:
And you referred to extensive litigation, long-running litigation.

[01:18:34] Speaker 04:
But these plaintiffs on these claims only knew what protocol they would be executed under after this court

[01:18:44] Speaker 04:
handed down our decision in April of 2020, and they promptly filed suit, and the district court set, this is not Buckloo, this is not Glossop, and this is a very different case where the, yes, the convictions were long ago, but when you look at what's accounted for the time since then, is there a dilatoriness that you would point to on the part of

[01:19:14] Speaker 04:
either of the plaintiffs, for example, that Mr. Meltzer represents.

[01:19:18] Speaker 04:
Because I appreciate it, and I absolutely understand that the Supreme Court has said there is a public interest in prompt carrying out of a sentence of death.

[01:19:30] Speaker 04:
But I also think that nobody does.

[01:19:33] Speaker 04:
There is also a public interest in legally compliant process, not just constitutionally compliant, but statutorily compliant process.

[01:19:41] Speaker 04:
So I guess the question is,

[01:19:44] Speaker 04:
where is the delay that's relevant for purposes of the weighing of the factors?

[01:19:51] Speaker 02:
I don't think that we have tax delay overall in terms of bringing suit in terms of Hall and Bernard.

[01:19:57] Speaker 02:
We do think that they could have gotten to this court faster and given that their execution, Mr. Hall's execution had been scheduled and Mr. Bernard's co-defendant had already been executed, that deciding to file additional motions to reconsider

[01:20:13] Speaker 02:
may have deprived this court and Supreme Court of time to consider their claims.

[01:20:18] Speaker 02:
But more generally, I think that the Supreme Court has talked about not necessarily just delay on the part of an inmate, although that's certainly relevant, but also just the time it takes for states and the federal government to effectuate death sentences at all.

[01:20:34] Speaker 02:
Recall that you can't schedule an execution until many years of appeals

[01:20:40] Speaker 02:
And post conviction remedies.

[01:20:41] Speaker 02:
And if at that point, it's only at that point that inmates open their third front and they say, okay, Well, my sentence is bad.

[01:20:48] Speaker 02:
My conviction is valid and my sentence is valid and I've been through, you know, in state state habeas maybe in federal habeas You know, we're 20 years on and the Supreme Court has said that it is the duty of court.

[01:20:59] Speaker 02:
It has permitted method of execution challenges outside of the habeas context and

[01:21:05] Speaker 02:
And we have not disputed that they can bring, as long as they're not actually challenging their sentences, we have not disputed that they can bring this suit.

[01:21:12] Speaker 02:
But it needs to conclude expeditiously so that we don't end up in sort of a habeas redux where you're multiplying the entire stages of litigation.

[01:21:21] Speaker 02:
These plaintiffs have now had the benefit of, I think it is something like five injunctions, all of which have been vacated by either this or the Supreme Court.

[01:21:32] Speaker 02:
The original plaintiffs were scheduled for execution in December of 2019.

[01:21:36] Speaker 02:
The case has been hard litigated and fought against.

[01:21:40] Speaker 02:
Of course, seven and six plaintiffs and one more who is not a plaintiff have been executed with this court and the Supreme Court's permission, essentially by vacating the only injunctions blocking them.

[01:21:55] Speaker 02:
At this point, we think that the equities strongly favor going forward

[01:21:59] Speaker 02:
with any more scheduled executions.

[01:22:02] Speaker 02:
Again, the only thing that has happened since that time is that they have received more process and they lost on the factual finding.

[01:22:11] Speaker 02:
I see I am over my time.

[01:22:12] Speaker 02:
Happy to answer any remaining questions.

[01:22:17] Speaker 02:
I do want to just, I'm not trying to throw up jurisdictional roadblocks, but just to prevent any future jurisdictional mishaps on the FDPA.

[01:22:27] Speaker 02:
I believe this morning that plaintiffs

[01:22:29] Speaker 02:
made the 54B motion that they adverted to in their reply brief.

[01:22:35] Speaker 02:
The United States does not oppose the 54B as to all plaintiffs on the FDPA claim in substance.

[01:22:41] Speaker 02:
It is not entirely clear to us that the district court retains jurisdiction to enter that given the notice of appeal, defective though it was as to the FDPA, so I would just

[01:22:52] Speaker 02:
Note the existence of the indicative ruling process in FRAP 12.1 and in Federal Rule of Civil Procedure 62.1.

[01:23:00] Speaker 02:
I'm not taking a position on there.

[01:23:03] Speaker 02:
We have no interest in having this tied up in jurisdictional tangles.

[01:23:08] Speaker 02:
But we wanted to note that it is not clear to us that the procedural mechanism by which plaintiffs appear to be trying to remedy their jurisdictional problem are correct.

[01:23:22] Speaker 05:
My understanding is that the government has already agreed to follow the states.

[01:23:31] Speaker 05:
I think they're both convicted in Texas.

[01:23:34] Speaker 05:
The two that are up now on the stay motion have both been convicted in Texas and one or both has asked to be executed after six o'clock and the government has agreed to do that.

[01:23:47] Speaker 05:
Ms.

[01:23:48] Speaker 02:
Hall has asked to be executed after six o'clock.

[01:23:51] Speaker 02:
And so that's when his execution has been scheduled.

[01:23:53] Speaker 02:
Bernard has not made a request.

[01:23:55] Speaker 02:
As of Hall, we said we'll consider granting it if he makes a timely request, that the hour is usually chosen about a week before.

[01:24:02] Speaker 02:
But we think that that obviates the discrepancy that they've pointed to.

[01:24:08] Speaker 02:
Moreover, the district court, even though they had not, the claim somewhat shifted.

[01:24:13] Speaker 02:
The original claim was that the whole protocol was

[01:24:16] Speaker 02:
no good because of this inconsistency.

[01:24:18] Speaker 02:
Of course, we think that's inconsistent with this court's prior opinion.

[01:24:21] Speaker 02:
I think the district court rightly thought that plaintiffs now wanted a court order directing compliance with Texas provision 43.14 and sort of preemptively made the determination that an injunction would not be appropriate given the lack of irreparable harm on that score.

[01:24:41] Speaker 02:
So we don't think that there's any even conceivable basis for

[01:24:45] Speaker 02:
a remand or an injunction on that basis.

[01:24:47] Speaker 02:
And I should note, as explained at length in our brief, we think that that provision is not even incorporated in the FDPA under proper construction of this court's prior opinion.

[01:24:59] Speaker 05:
Can I just ask, we had an exchange about whether under, if there were a situation where the Bureau of Prisons were administering drugs to prisoners generally,

[01:25:10] Speaker 05:
without a prescription and whether there could be any, you said there couldn't be a lawsuit under the FDCA, but you weren't aware if there were some other statute that the prisoners could sue under, and fairly enough you weren't aware of the U.S.

[01:25:25] Speaker 05:
code relevance at that point.

[01:25:28] Speaker 05:
Could you file a letter with the court by 10 o'clock tomorrow morning

[01:25:31] Speaker 05:
advising if there are other statutes under which the United States believes they could sue to enforce the FDCA.

[01:25:41] Speaker 02:
And just to be clear, the scenario that Your Honor has in mind is where BOP, I'm writing this down because I want to get it right, is administering drugs

[01:25:53] Speaker 02:
Prescription drugs within the meaning of SCCA.

[01:25:56] Speaker 05:
Otherwise, prescription drugs, yes, without a prescription to prisoners.

[01:26:02] Speaker 04:
Non-dead prisoners?

[01:26:05] Speaker 05:
Pardon?

[01:26:05] Speaker 05:
Just prisoners generally.

[01:26:06] Speaker 05:
They just say, we don't want the paperwork.

[01:26:08] Speaker 05:
We're not going to do prescriptions inside our prison walls.

[01:26:12] Speaker 05:
For people in our prison walls, they don't get prescriptions.

[01:26:16] Speaker 02:
We will file a letter on that topic by 10 AM tomorrow.

[01:26:18] Speaker 02:
Thank you, Your Honor.

[01:26:20] Speaker 05:
Thanks.

[01:26:20] Speaker 05:
I have more questions for my colleagues.

[01:26:23] Speaker 05:
Okay, Mr. Metzler, we'll give you three minutes for rebuttal.

[01:26:29] Speaker 05:
No, Mr. Metzler, I'm sorry.

[01:26:30] Speaker 05:
Mr. Driluski, I apologize.

[01:26:33] Speaker 00:
Thank you.

[01:26:33] Speaker 00:
Thank you, Your Honor.

[01:26:35] Speaker 00:
I'd like to turn back to Judge Pillard's hypothetical, if I could.

[01:26:40] Speaker 00:
So the BOP is administering a drug

[01:26:43] Speaker 00:
for heart conditions without a prescription, non-death penalty prisoners.

[01:26:48] Speaker 00:
And let's say there's some risk that the drug will cause heart attacks in its recipients.

[01:26:54] Speaker 00:
The prescription requirement ensures that a trained medical professional will assess those risks

[01:27:01] Speaker 00:
will look at the available precautions to take based on the current medical science and take documented steps to avoid those risks, like, for example, adding another drug to address the risk, even if the probability of heart attacks may be less than 50%.

[01:27:18] Speaker 00:
But in that hypothetical, by evading those statutory requirements, the BOP would necessarily expose prisoners to a risk of bodily harm.

[01:27:28] Speaker 00:
We believe that constitutes irreparable harm, and that

[01:27:31] Speaker 00:
And that's just what courts held in the COVID cases that we cite in our brief.

[01:27:35] Speaker 00:
And to address Judge Millett's point, now does that scenario rise to the level of a constitutional violation?

[01:27:43] Speaker 00:
The answer may be, maybe not.

[01:27:45] Speaker 00:
But even if it doesn't rise to deliberate indifference,

[01:27:49] Speaker 00:
We submit it's harm for purposes of the statutory violation.

[01:27:53] Speaker 00:
It's irreparable harm that can be remedied through enjoining the defendants and the BOP to comply with their statutory requirements.

[01:28:07] Speaker 00:
Judge Mallette, you asked about a punch to the stomach.

[01:28:10] Speaker 00:
And my friend's answer was, that's so far from the allegations here.

[01:28:15] Speaker 00:
We agree this is much, much more what we have

[01:28:21] Speaker 00:
what the district court itself credited when it said it continues to be concerned by the possibility that plaintiffs will suffer excruciating pain.

[01:28:31] Speaker 00:
What that means is plaintiffs will now face the prospect

[01:28:35] Speaker 00:
their executions with a possibility, at least, that they will suffer pain that's been described as akin to torture, knowing that the district court said there's a possibility that that will occur.

[01:28:48] Speaker 00:
We submit that harm is real and concrete and certain.

[01:28:52] Speaker 00:
And to conclude that it isn't irreparable harm here, because the probability that they suffer that torturous pain is somewhere less than 50%, we submit should not stand.

[01:29:03] Speaker 00:
The last point I'd make is just going back to the APA where I started, we sincerely hope that a declaratory judgment and setting aside the protocol based on defendant's violations of law should be enough to prevent defendants from continuing to act contrary to law.

[01:29:22] Speaker 00:
So we believe that at the very least, that should be

[01:29:24] Speaker 00:
ordered as mandated by section 705, the Shell language, excuse me, 706.

[01:29:30] Speaker 00:
To the extent more is needed, we believe that the irreparable harm is present here and the district court erred in holding otherwise.

[01:29:39] Speaker 00:
Unless your honors have any other questions.

[01:29:43] Speaker 05:
Any questions from my colleagues?

[01:29:45] Speaker 05:
Well, thank you very much.

[01:29:48] Speaker 05:
With that, if there's no more questions to my colleagues, and thank you for the, oops, sorry.

[01:29:53] Speaker 04:
Melser gets some, no.

[01:29:56] Speaker 05:
If you want to ask him a question, I'll certainly give him time.

[01:30:00] Speaker 05:
Mr. Melser, would you like a minute?

[01:30:05] Speaker 05:
In the courtroom, there you go.

[01:30:09] Speaker 07:
I'm happy to rest on Mr. Grylowski's rebuttal unless the court has questions.

[01:30:14] Speaker 05:
Do you have any?

[01:30:15] Speaker ?:
OK.

[01:30:15] Speaker 05:
Okay.

[01:30:16] Speaker 05:
Thank you very much for your question.

[01:30:18] Speaker 05:
Thanks.

[01:30:19] Speaker 05:
Thanks.

[01:30:19] Speaker 05:
We appreciate the emergency preparation for it and the case is committed.