and cosmetic claim the circumstances in which this case now sits we submit are extraordinary the district court has held conclusively the defendants are executed executing prisoners in a way that violates federal law and yet plaintiffs have been left with no remedy whatsoever for those proven by elations and no way to prevent defendants from continuing to act contrary to law this result was reached in error for the the evidence regarding a record of harm was fundamentally flawed because it applied the wrong standard based on its misreading of the supreme court's or curium decision in leap and rd regardless of the district court's assessment language of this section which provides in no uncertain terms that a reviewing court shell hold harmless show chokehold unlawful and set aside agency action not in accordance with the law with no such killer i think that that the answer is no and that's based on national mining this court's decision by the late judge williams it that in that case what the court emphasized is both nder the again under seven upsets the court awarded an injunction from the the agency in forcing the set aside regulation especially an injunction a nationwide injunction and said national might have decided before the supreme court's decision and even a which really has clarified a kind of a cross cutting understanding that permanent injunction really depends on the finding of irreparable harm it  execution by lethal injection doesn't derive from the protocol so this isn't a this isn't a case in which were we to say the protocol violates the from drug cosmetic act but they would like authority that authority derives from the  i'm interested in what you're pointing to because in your briefing you do seem to point to the same for both and are there lesser other harms or more per se harm from failure to get a prescription or tell us more  thank you judge i will and i'll move over to the irreparable harm point now on the assumption that we do need to show it 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 is both surprising and slightly disturbing moving on to having to show reparable harm the district court got it wrong  in assessing the evidence there because if you placed much too much weight on the per curiam decision in barbarously now that that decision was decided in the context of a preliminary injunction  a last minute request to stay an execution 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 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 cruel and unusual punishment claim but here we're in a different posture and revealing with a different claim and different analysis the defendants have been found to be acting in prophylactic safeguards and those are there specifically that the court baby held to to ensure that lethal injection drugs are administered humanely and to minimize the risks of pain and suffering by failing to comply with those safeguards the plaintiffs here been exposed to a risk of severe bodily harm and yet it doesn't take a lot of digging to see where the district court point of harm it held that even if plaintiff's evidence might prove that paul an area occurs in a prisoner while still conscious that's still would not be enough because the supreme court ruled pentobarbital is not likely to cause an unconstitutional level of pain in other words in the court's view that there's no amount of evidence of pain that would be enough to show irreparable harm here but that's not the likely standard and we're not dealing with a constitutional level and we're simply talking about irreparable harm arising from and relating to defendants continuing violations but more importantly the supreme court never said that it simply held that the competing evidence before hand again in the context of a last minute request to stay an execution was insufficient just to show a substantial likelihood of success on the constitutional clash right so one of the mom and my question is is there any other harm that you're relying on a minute it struck me that if if your prisons officials were to make a determination that they were going to administer not only fell out drugs to death sentenced prisoners without complying with the a those prisoners sought to enjoin that conduct they would likely be able to show that that would sound irreparable harm and i wonder if you agree and if you or if you think there are some other harm other then that flash pulmonary edema that i understand has been the focus on the record and both of the claims in this case  it you have to look at what the purpose of the case is to begin with it is a prophylactic that is meant to provide safeguards in the administration drugs so that there is no is that increased exposure to that risk of severe bodily harm and we put in the evidence on the record that there is very very strong evidence that this pollen or demon is severe bodily has its own witnesses there are doctors who don't believe an analgesic is necessary and so if they have a doctor who writes a prescription for kind of arbitral and nothing else nothing has happened but i'm just not understanding credos what the ca mandates and brings with it is the requirement that defendants seek out professional medical consultation which would bring with it informed clinical judgment based on the most current opioid but that what it what it is is more than that it is a process i wish the medical assessment is made as to whether or not a particular execution is being done in a humane way and the district court we have been failing to grapple doesn't add to the risk of severe bodily harm so in this case it's not simply the goal to execute people the goal even even defendants will agree is to execute them in a way that i'm missing you i think i think the injury is repressed again whether or not a prieto is is prescribed at the end of the day the point is the protection the safeguards in place by the c as a prophylactic statute is that medical process and assessment as to whether it's necessary or not so we can speculate in government that's actually but that hasn't been the way you've been framing it like to me i'm just not sure why the have you but but you do keep going back to the flask pulmonary edema and you know that you're right that the government will concede that that they want to have achieved your main execution but unnecessary but here in the context of a reputable harm or an f t c a violation the district court itself recognized the possibility even at the end of the day that there is a possibility that these prisoners will suffer excruciating deaths and so what the f t c a does is it puts in place of safeguards around the administration of pentobarbital all 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 of the pain that was a drug that was already regulated by the f t c and it doesn't lose its status or its definition is that depending on its intended use of a drug is a drug is it brought up and although it's used in the lethal injection contacts it remains subject to the f t c essay and the policy is the core principles behind the f t c or continue to apply even in the lethal injection context i think that's what distinguishes this case may still come into bear to ensure that the drug use is used as intended to ensure or to mitigate the risks of an inhumane and the court there analyzed this and said when when a lethal injection drug isn't used properly it doesn't function as an intended there is a risk that prisoners executed by it will suffer pain will suffocate and will will will  position here conflicts with the necessary premises we think that is such a and then the supreme court overturned that day in july without any further  fifty two stage and has the district court already made a finding that you know based on on the evidence that is the very same that would be made under all fifty six dollars or is there more decision in our was a preliminary ruling it was not a final adjudication on the merits 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 sometimes rule the parties win on the merits down the road in a different procedural posture and involving different evidence and the nd point is the evidence continues to  without any precautions put in place is causing prisoners to feel the effects of flash on an area team up while still conscious so there i have you but because here you got more evidence than the district court's ruling in area while still conscious that's not enough given what the supreme court held in bar versus lee and we think that is totally wrong because what it in essence the court is saying is that no  that finding she made that finding an appearance before she turned to what the supreme court has done there she's just talking about all the the evidence the hearing she had with the expert witnesses and she found that they  if you don't is the point you would get more evidence if you went past the fleeting stage or that you have more of a dense or we haven't been to the same and we just have it all turns on her separate and she grounds that ruling in her reading of our verses lee we think that was a mental error and so what she's saying is that if we have new executions they come out and they show their and they constitute proof that someone is suffering from another source or ok another symptom of the problem beyond saying that we needed to show evidence that cast a doubt more than one hundred executions carried out with and to our talk to the district court also but just despite recognizing some serious flaws in defendants to act herbs salt of the plaintiffs or failing to completely undermine right now again we think that that reflects the skewed view that the district court standard made by the government and then i will certainly address any questions that the court may have the government suggests in footnote the read its opposition to the state motion that that the movements need to make a clear  indisputable showing of a right to released in order to receive the stay in this case and that is just not consistent with how the supreme court has treated has treated challenges  that the the supreme court granted the stay pending its disposition of the petitions to research your ari 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 and so if the titians have been required at the outset to make a clear and indisputable showing overwrites relief the supreme court would have been all three of those stay it obviously did grant those stays and ultimately it did not rule for petitioners but what that shows is that they were applying it's difficult to stay standard from and can and not the standard that the government just hears of what the government is in fact asking for here is a departure from standards require practice on this type of state motion and we don't think that that's wor showing of our approval arm that we were the risk of harm that we would need to make here is just slightly lower standard compared to the if amendment standard and we would suggest that essentially  here you know the b o p has put forward experts paid experts that have said that a sedative isn't necessary but we would argue that an objective clinician would a clot a medical judgment on a clean slate and given the risk of harm and the lack of any downside away as a prescription well what we think as mister charlie 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 told should be given in these circumstances and under what circumstances it would be given whether the doctor would also prescribe a sedative along with that and so if ultimately the the e o p the position that you heart condition and i needed prescription i don't know what people get injected the app it had been given to me by prescription and then the president said is required under other circumstances to get a prescription for medication that is provided to prisoners and so you know we certainly you know we believe that we have pointed what the harm is here of an s t c a violation of not allowing our not allowing a medical doctor to determine the circumstances under which pentobarbital would be prescribed to our clients but you know there's a obviously a more foundational question you're asking here that we don't disagree with and that i i believe i haven't needed myself but if you can't hear me please let me know if you want to know i can't see a judge route i don't know if there was an announcement i missed at the beginning but i can see the judges let hillary but not  or consider the equities to warrant a k ting the injunction that was entered in either way we think that that decision underscores the impropriety of reversing the district court's provisions of or to restrain violations of the f c c a shall be in the name of the united states subsection b goes on to provide a very narrow part out to that united states only rule for states in very specific circumstances and we think that this is the sort of express congressional in disha of a statute that precludes resort to the a p a diesel because  actually you know in cases like block the community nutrition the court said we need to examine whether their particular class of a clean tipped or attempting to use the a p a to say something is wrong with the scheme we need to see if congress wanted that particular class of persons to be able to sue and there of course it was implicit the court found that in the at least the milk marketing scheme because congress had so carefully law which obviously isn't going to happen when the government enforced things and so are you aware of a case where there was no alternative mechs recommend them for private enforcement or other affect affected individuals and may not federal enforcement against other people that's clearly not against itself your honor i think most federal criminal violations work that way it's not you know absent you know some sort of ki chan suit under the false generally the 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 i think where congress has reserved enforcement authority to the government that is the type of preclusion under seven hundred and one of the a p a that means that congress has has put aside and moreover and heckler be cheney the supreme court found that the trying to sue to have you comply with the statute for people who are in your custody who cannot fend for themselves and then your theory thinking of judge heller hypothetical the federal government just to have less paperwork all drugs and ministered to be a p prisoners will be issued without prescriptions without the superintendents of a doctor that's been forced to the prescription process under the f t c a and your position is nothing to be done about tha let's the government says and so i think there there might be other forms of to play a local thing what i do i don't know specifically because i know that there are statutes governing the ways in which prisoners can telling me no your honor my position is that i don't know what other statutes might provide recourse or what limits congress may have provided on such recourse maybe not aware of any other statute that would let them sue for the the hypothetical and i'm sure in judge dillard's here i'm not but i'm not saying that that one doesn't exist i'm saying i simply don't know and i don't want to give the court an incorrect answer but i think at crux they could not use the f t c a to try or the a p a to use the  restrain an f t c a violation but if there was another statute they should have used hear about the government would have discovered that by now i can't even conceive i don't know if every cent you know in the book but i see a lot of them and i can't conceive of what that other statu i do not know your honor and i don't want to spit balling give the court an incorrect answer we can look into this i'm pretty sure i'm pretty sure given the government's position on expansion of the dems that it's not going to invite the expansion to a statutory may or may not be available or what other form it may take but i do not think it could take the form of an a p a suit saying you're violating the f e c a now i do want to turn to the actual bases on which the district court ruled here because of course the only things that have happened since august th when this court vacated and at the cia base conjunction for failure to make factual findings on a reparable harm are that the district court decided that the evidence reflow mind could differ it held an evidentiary hearing to assess witness credibility it listen to those witnesses and then it issued factual finding that plaintiff had not carry their burden  only irreparable harm they pointed to here which is the risk of pulmonary edema while sensate now there were two findings and they are independent bases for the court's refusal to enter the requested injunction the the one that i believe judge hillard referred to earlier and that is the disconnect between the asserted statutory violation that the lack of a prescription under the f t c a and the relief that they are seeking there is nothing in the record to support the speculation about what doctors would do or what it do and so just getting them a remedy for the violation they think that's just getting them a prescription if that were possible and the government does not think it  underscores the degree to which they're trying to use the f t c a to reforest execution protocols in a way that it's far beyond anything the f t c a contemplates or dictated let me let me ask you  injunctive relief and just talking about the you know the factual dispute that the district court identified in the record and then said you know it's not it's not a basis  what's your view about whether and when it has been or will be fully resolved has it already been resolved in terms of you know she said there's conflicting evidence  take the district judge to have resolved that but rather to say at least with respect to the th amendment claim it doesn't rise to the level of cruel and unusual  that trial it's just it's a little unclear to me given both the march of the of the emergency motions and the progress of the underlying case what the government's position is about about that question but just to clarify the timeline here at docket one hundred and ninety three back in august the district court granted the government's motion to dismiss the th amendment claims with respect  when the district court was weighing the evidence that the that the parties had put before her and trying to decide whether the plaintiff had carried their burden of a stablish ing that it was likely that they would actually experience the only harm they pointed to the court was only considering that in the context of an f t c a violation now we think that the court properly looked to the supreme court's decision and lead not to resolve any factual question you know that the district court has just gone through had explained sort of in a blow by blow away what the evidence in the record was and who she sort of thought had or hadn't undermined two and she finds repeatedly that the plaintiffs under the standard they put forward the likelihood standard had not carried their burden and then the district court says that it's looking to lead to decide sort of when it is appropriate what warrants injunctive relief and we think the district court appropriately looks to the cube about when to use that equitable discretion given that inly itself the district the supreme court had before the district courts sort of preliminary assessment of the evidence before she heard from the witnesses before she had any or started before it had any evidence from doctor crowns the government expert on which the court primarily pointed to ok that's point but never thought it was go ahead with the court that it was a virtual medical certainty that these harm would occur and yet the court did not think injunctive relief was appropriate and i want to negate any idea that this was because of a last minute request by the plaintiffs that request had actually been pending for weeks it was because of last minute action by the by the district court and by last minute the court vacated the injunction even as to an execution that was six weeks longer than either mister hall or mister bernard's execution here that is the type of last minute intervention that the court has said is inappropriate even in the face of then to support that district court's assessment that it was a virtual medical and certainty that plaintiffs would experience pulmonary edema now the only thing that's happened since then think that there is no basis even on any of the claims in the appeal for this court to direct the other to enter an injunction pending appeal or to to direct the district court to enter the injunction that plaintiffs seek at most even if they were even if they're right that there was some sort of error in fact in a fact finding process at most that would leave this court with an absence of factual finding which is exactly where it was on august th when it vacated an f t c injunction for lack that is taking a preliminary injunction and holding to be determined they have on the merits and that does not seem correct to them the district court says that that she is looking at what the supreme court did in a holding that the players were not likely to succeed in lady and then she says because they think that i mean the they have currently on the appeal challenges to both of those holdings and i think they're as i take it their hope their challenge to the intimate holding is basically the district court said oh our you know determination when our gross motions for summary judgment or in a factual trial which is why i was asking you when do you think that happens or do you think that already happened if they did not i do not think that already happened the hearing that was held w the supreme court latest you know let's treatment of the th amendment we think the type of pain that they have alleged here even is true and i do want to make extremely clear that the government does not think that these inmates will experience pulmonary edema while sensate and i have backed by expert testimony aren't i so i and that's your position absolutely but so i think what you're saying is that this factual issue doesn't need to be resolved because it's legal you're relevant because even assuming that the district court would have credit all the medical evidence that the plaintiffs have proffered in this case it is just not that what they've identified is not cognize able in your view under the th amendment that's right your honor and we think that by the district court's judgment dismissing out of twelve basic stage was proper we think that they simply did not put forward enough moreover we think that they did not they failed to plead no available alternative that significantly reduces any pain experienced attendant to death that the government has or lacks a legitimate pain a logical reason for not adopting they pointed to only to a point to a two drug regime and opioid plus a plus the point of our bottle and they pointed to the firing squad 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 illegitimate kena logical reason not not to use it a state never has to or state for the federal government never has to be the st to test run an untried protocol every indeed you it's a matter of law ruling that you take her to a maid so even looking at the pleadings she is saying as a matter of law if everything you're pleading is true civil procedure but the evidence was in for poor injunction and then the underlying case was at the pleading stage so the question is not really whether she cries for evidence but when she cries that her there are allegations and they for going to i'm having a little trouble hearing but but i think i agree that the that the district court properly recognized that the extent of pain alleged in the complaint did not meet the th amendment high bar because just it if it's not a high bar that the supreme court has sort of reserved the issue of whether or not they're sort of and pension requirement it's certainly you know if that state is somehow intending to add pain the court has talked about super added pain terror disgrace and so if that's what you mean by gratuitous sort of that the state is either intentionally or negligently adding paynter disgrace to a means of effect think that that type of super added pain could be on a different footing and there are no allegations that the government is somehow super adding pain here is the allegation is that the method is and her understanding and i'm not sure they would agree i think they would say if i understand their argument is that it is wholly a mess now i know your back hurts i'm not asking about how i'm just trying to understand the legal test here it's wholly unnecessary make people suffer the flash pulmonary edema even if you're right that it's not it's bad but it's not so bad and it violates the th amendment in its own right but it's wholly unnecessary is gratuitous pain even if it's not so it's more painful than hanging out at that level it's painful but it's wholly unnecessary doesn't violate the th amendment or not by any government in the united states that attempts to super ad pain here a disgrace there has been an earnest desire to move to ever more humane types of execution and that is why the supreme court has never and validated a single execution superadded pain and the th and then it but if you're asking me to sort of give examples or quantify of what that type of superadded pain might look like i can't because the supreme court has never identified and you can't but you can come up with a hypothetical just like to not punch in the stomach was a safe i pathetically i guess not the government believes it could do that i thought but i don't i am not i am not agreeing and i am certainly not conceding that we would think that that is an appropriate or constitutional i am not taking a position on that question your honor because that if you had a brain fart and since additionally other baby i'm taking a position your honor we are so far from any of the allegations in this case and if there were some sort of constitutional principle that required us to affirmatively eliminate any of the sort of necessary pain that attends the death we would have seen very different results and in fact the supreme court in a very clearly said judges should not become sort of  sort of been free your honor my point is that that's the supreme court's language about a board of inquiry indicate that there is a very high bar before court should get involved i'm not saying that any time a court might take action to restrain a violation of the th amendment that that is a judicial board of inquiry 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 and it is so far so high in fact that the supreme court has never authorized it let me ask you to back up about the do you see a claim and the record i asked you and we had an might be different and that was some point that plaintiffs were arguing that she didn't appreciate so i just wonder america says it's not the same structure you've been saying that there is this sort of thresholds you know the nonpayment but nonetheless not the court start its analysis it says the record contains conflicting evidence and it runs through the different declarations from from each of the side the competing evidence it describes how the  plaintiffs are relying on autopsy evidence and then at the bottom of page thirty seven dollars after considering the conflicting declarations the court found that the question of whether an inmate will suffer a flash pulmonary edema before becoming insensate was one of pitch which reason my could inmate will be will be unresponsive to will appear unconscious but actually sort of non visibly be experiencing pain and that the fight is when you actually become insensate and so you know we we had put in copious evidence showing that we thought that the plane that somehow kind of our little get your lungs but not your brain it would make you experience pulmonary edema without also rendering you unable to of each other but the district court when it transitions to talking about lead justice in the september order is not talking about factual finding it's talking about what warrant the exercise of equitable discretion what warrant injun i'm not sure i would put it that way your honor but i remember there are two remaining equitable factors and i think that the i you know that the balance of equities and the public interest and hear what plaintiffs are saying is that because of the failure of pepper scription they can grind to a halt all lethal injections in the country 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 a one thousand have had have been unlawful all along and i think that as an act matter of equitable factor in equitable discretion it would be that hell wagon a dark you allow the f p p a to enter an injunction helping lethal injection where the th amendment put it i think that it is running litigation but he's played us on these claims only knew what protocol they would be executed under after this court handed down our where that's relevant for purposes of the way the factors i don't think that we have tack to delay overall in terms of bringing suit in terms of holland bernard we do think that they could have gotten to this court faster and given held execution had been scheduled and mister bernard codefendant had already been executed that deciding to file additional motions to reconsider may have deprived supreme court of time to consider their claims 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 in the method of execution challenges outside of the haiti of context 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 but it needs to conclude expeditiously so that we don't end up in sort of a hey vs redux where you're multiplying the entire stages of litigation if plaintiffs have now had the benefit of i think it is something like five injunctions all of which have been vacated by either who is not a plaintiff has been executed with this court and the supreme court permission essentially by vacating the only injunctions blocking them at this point we think that the equities strongly favor going forward with any more scheduled executions again the only thing that has happened since that time is that they have received more process and they lost on the factual finding you see i am over my time be to answer jurisdiction to enter that given the notice of appeal defective though it was as to the f t p eight so i would just note the existence of the indicative ruling process and scrap twelve point one  one i'm not taking a position on there i just we we we have no interest in having this tied up in jurisdictional tangles and we but we wanted to note that it is not clear to us that the perceived rule mechanism by which plaintiffs appear to be trying to remedy their jurisdictional problem six o'clock and so that's when his execution had been scheduled barnard has not made a request as of hall we've said we'll consider granting it if he makes a timely request that the hour is usually talking about a week before but we think that obviates the discrepancy that they pointed to more over the district court you know even though they had not that they claim somewhat shifted the original claim was that the whole protocol was no good because i think it is just if we think that's inconsistent with that i think the district court rightly thought that plaintiffs now wanted a court order directing compliance with texas provision forty three dollars and so to sort of preemptively made the determination that an injunction would not be appropriate given the lack of a record will harm on that score so we don't think that there is any even conceivable basis for our remained or an injunction on that basis and i should know we i think as explained at le in our brief we think that provision is not even incorporated in the f d p and very proper construction of the court's prior opinion we just heard an exchange about whether under they were situation room and we were prisons were drugs prescription drugs within the meaning of that c c a otherwise prescription drugs without a prescription to prisoners that are not knocked off part of the prisoners generally they just say we don't  so the b o p s administer in a drug for heart conditions without a prescription not death penalty prisoners and let's say there is some risk that the drug will cause heart attacks and it's recipients the prescription requirement ensures that a trained medical professional will assess those risks 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 fifty percent but in that hypothetical by evading those statutory required requirements the b necessarily expose prisoners to a risk of bodily harm we believe that constitutes a reparable harm and that's just what courts held in the code of cases that we cite not ruth and to address judge millet's point does that scenario rise to the level of a constitutional violation the answer maybe maybe not but even if it doesn't rise to deliberate indifference we say that it's harm for purposes of the statutory violation it's irreparable harm that can be remedied through enjoying the defendants and be okey dokey to comply with their statutory requirements judge millette you asked about a punch to the stomach and my friend's answer was that so far from the allegations here we agree this is much much more what we have shown through our evidence and what the district court itself credited when it said it continues to be concerned by the possibility the plaintiffs will suffer excruciating pain what that means is plain just will now face the prospect there are executions with a possibility at least that they will suffer pain that's been described as a change of torture knowing that the district court said there's a possibility that that will occur we said that harm is real and concrete and certain and to conclude that it is interoperable harm here because the probability that they suffered that torturous pain is somewhere less than fifty percent we submit should not stand the last point i'd make is just going back to the a p a where i started we sincerely hope that a declaratory judgment and setting aside the protocol based on defendants by lesions of law should be enough to prevent defendants from continuing to act contrary to law so we believe