terrific debilitating life threatening and often catastrophic conditions then applies to a total of fifty five persons in the united states patients who receive it those who have prove resistant the word is refractory to other therapies that have seen their health restored their lives changed or saved through this treatment to sustain its about face under the a p and provided a reasonable and plausible explanation for reversing a policy on which patients have defended depended for years if he has failed in every one of these respects  a concedes that there is a population of patients with these conditions who are refractory to other therapies to comply with the criteria of the beginning statute it must explain why it now concludes after thirty years of reliance that the risks of the device so outweigh its benefits that it is an reasonable to continue using it even for these persons who have nothing else so are you conceding that they can do this it all it really thought your baseball was under selection for in ninety six that they simply could not do what they're doing or that it practicing medicine when they basically and attempted banning on the use them in my meeting have you conceded that border you oh not a documentary i'm going to right and and three hundred and ninety six is really an aspect of how the entire system works the system the way the system is supposed to work and the way it did work on this until who had tried other therapies was up to the health care practitioner up to the doctor that f d a f d a is the gatekeeper for what devices should be and the banning provision so as i understand your position it would mean that essentially and the agency as an all or nothing power in terms of banning it is that it either has to ban the device in all its uses or device and as i understand your argument it's that the agency either has to say that device can't be used for anything or it has to allow the device to be used and my question is why would congress have wanted to do that if congress if it's actually true i know you dispute it but if it's actually true that the device is in fact injurious and not at all efficacious for some uses but is sup efficacious for other uses then what is the rationale by which congress would have said we'll still be agencies stuck they either have to allow it for all the uses even the harmful ones or they have to disallow it for all the uses even the effective ones  this is the decision the congressmen from the beginning what was carved out was what is what form of regulation is to the f b i and what form is a regulation is up to the states and  up to it is up to the practice of medicine and if a device and and this was a dividing line both for drugs and for in for devices and if there is a device that you have allowed to go into i be used and to be distributed in congress and if it has a proper use if it has whatever minimum amount of effect of this or safety that is enough to put in an income risk we will leave it to the  the physicians the hospitals the experts on individualized re trail medicine to decide is this good for this patient it doesn't mean that there's no regulation it just means that it's not was the context of the beginning being statute was not talking about you know some kind of device that had previously been approved by the f d a that had that was supported by some sort of body of scientific evidence into these kinds of things and when when the bionic statue came out what do you think that the bad the the agency was barred from the specific ban on powder what with surgical for the surgical use as it was banned for surgical uses but the same powder was not banned for other uses do you think that the agency was didn't have the power to do that and that was about the powder and the powder is the same as i understand that's right but but it's so is it then is it your position that that was that the f d a was barred from doing that no i'm not i'm saying that u there are this statute clearly applies to our situation what the statute says is that nothing that you have to show limited interfere with the authority of a health care practitioner to would you say that a ban is a restriction it could be but there is a definition of restriction in the f t c yeah and it talks about things like there is a restriction here actually has to be prescribe by the doctor that can be other restrictions that's what they're talking statute which regulates introduction in interstate commerce by people selling drugs and devices on the one hand but not retail practice of medicine by practitioners on the other that you are exempted by the practice of medicine and they told them that for ten straight years until they started going down this road toward this rule and at that point they said we have just learned that it doesn't apply they didn't explain please the court my name is michael flamby and i represent the judge rotenberg educational center i certainly would agree that by banning only two uses of a device used for self injury severe zope injury and severe aggression but specifically say it can be used for other uses such as smoking trying to stop smoking or nailbiting this is the practice of medicine this is the f d a getting involved in the practice  medicine and smoking itself is a self injury is behavior so the the difficulty in forcing this illegal use of the ban just raises other problems and you know the been the purpose of the bit of the banning statute  was to take a truly hazardous and deceptive devices off the mark it's only been used three times in almost forty years it was not promulgated for the purposes of making fine slices of what doctors can do with the  know the g d is clearly not hazardous or that of that would be true i mean you could you might be able to deal with powder that way i'm not sure that works actually but there's all kinds of examples like the popsicle stick there are also kinds of examples where the upshot of your position is that it's an all or nothing proposition that has to be banned even as the efficacious uses and that that bit that maybe that may be what you think the statute says but i think you have to come to terms with your position that that's what it means honor that the statute is it was clearly passed by congress to deal with a very specific issue and that is the continued marketing to the public of devices that are truly hazardous or deceptive again only been used t other times in history and it was really no dispute about the hazards the deception of those devices in this case the g d device is not hazardous it's it's unpopular it's unpopular with advocates who don't like i don't really think you're coming to advocates in their sympathizers peace of mind and to do so would literally reign hell on our clients who are innocent and thriving and who deserve to keep their lifesaving treatment and their only hope for health and i'm quoting the f d a is a devastating condition that leads to serious permanent bodily injury and repeated physical so assault nd f d a concedes that there are patients with severe life threatening self injury abuse who cannot be successfully treated with positive interventions in drugs or any other alternative treatment so three they f d a has conceded that the risk caused by banning e s d is for self pity and aggression for this population are petitioners with no other effective treatment puts them in the most dangerous risk imaginable the imminent and inevitable loss of life and limb and finally for the evidence of act side a identifies in the record even if true and we did we dispute them are not serious illness or injury and therefore do not satisfy the banding statute and they're not comparable to the loss of life or limb which is the condition our petitioner's would be in without e s d is for self injury and aggression and to try to save their ill fated ban f d a makes a patently arbitrary and capricious and most desperate finding that the g d d the only s d currently being used to treat self injury aggression and use it only one facility they claim it provides no benefit at all f d a makes this baseless claim giving no consideration to all of the hundreds of decisions and the hundreds of massachusetts court cases finding the jihad ged saves lives in causes no harm where all of the treatment fails further still the dozens of families of the people currently receiving the ged treatment have all told the f d a in writing that for my child without the ged my child will lose her health will lose her happiness will lose her freedom and world will return to her previous life of no effective treatment constant pain in utilization blindness sedation restraint and a locked ward and likely early death no quality of life not being able to satisfy the standard of the banning statute f d a ages and a multitude of other acts to try and justify its pre determined h h s ordered conclusion to ban e s d for self injury and aggression f d a ron fully enters the decades on debate among health care p practitioners about how to best treat severe self injury and abuse but that is practice of medicine which is statutorily not f d a jurisdiction f d a is using a bannock statute to tell health care for instruct health care practitioners that you can says that ran only randomized control trial research is credible and applicable not the real world evidence single case designs clinical research non clinical data that f d a relies on to clear hundreds of devices f won't even consider the hundreds of peer reviewed scientific articles articles approving skin sharp because that the writer might have been biased there might not have reported adverse events because one of the writers was on the editorial suddenly no longer is adequate despite f d a approving other devices with similar labels that require other types of treatments to be tried st before using the device on a refractory patient like  t there is just no evidence in the record that the current label isn't working and it is as you can see from the court finds f d a won't consider any of the doctors panel members judges parents who have told the da that the ged treatment is effective safe and the only it is not an illness or an injury pain is a very important sensation because it tells us that we are doing something that is injuring us or could injure us and we need to stop for these refractory patients the petitioner's the pain of severe s a if just put aside you are going about uses and devices we're just talking about a device and the only thing the device does is cause excruciating pain your argument is the f d a is barred from banning that device because the consequence of it is all it does is cause pain particularly f d a is prohibited from banning the particular use of a device i think that's wrong for a couple of different reasons initially both because the f t c a both overall and in three  recognizes that what a device is depends on its intended use and secondly that one is that it's not just that a ban impacts a practice of medicine as this court recognize i think was and regenerative medical right f no i don't think so your honor so for example if somebody was to manufacture let's say something starts up tomorrow to manufacture and distribute these devices and say right the only way that we're marking this the only way that we're selling this the only things that we're putting on this label is that this is for using this device is to use to shock people to stop self injuries and aggressive behavior that would be a band device if some other company comes in the markets man says the only thing that we're doing the only thing that we're marketing this for is for smoking cessation or something else that is not a looks to their intended use so we give a couple of examples of this for example some need prosthetics right are going to be class two when they're used to treat particular arthritic conditions because of the round the less none the less recognizes those that also true does band come with an off label so for example if a health care practitioner at petitioner's facility wants to administer  this device can they do that for a device that they already have it's never it's not newly on the market it's not new be distributed it's been in their possession for forty years can they use that on somebody who is at that facility i think that's going to depend on the particular factual scenarios they're in if it can explain why ok or a device that has been manufactured and distribute over ready for this intended use i think comes within the band device for a device that is not but it might come within the band device but what does that mean in terms of three hundred and ninety six so i think then i think about health care practitioners not able to prescribe or administer that device you know so if i can be there because there are other cases that could potentially be implicated by how this this gets divided so for example under three hundred and ninety six dollars general practice of medicine issues practitioners who have a patient practitioner patient relationship can prescribe off label devices even it's even if it's for something that's can can prescribe right yes as long as it's an otherwise legally marketed device yes they can do that now and i want to be clear because this has potentially outside implications here when a physician is acting as a manufacturer distributor there can be particular consequences if i can just give one example to explain why there was a case out of the th circuit where a doctor was reusing single use needle guides for  distributing that to people in their practice the th circuit a public criminal conviction for that because it said when you are using that essentially unsanitary and adulterated device and acting as a distributor to other people forte that doesn't come with  it depends on the particular factual snow known to mid band on you then you tell me is it possible for the doctor to do that for then you can explain your honor i think generally yes if it's within a legitimate patient practitioner relationship and it's there i'm not talking about distribution to another doctor i'm not talking about that so you can take that one off the table all i'm talking to because i've as that as i understand it that's the complication that's raised by the th circuit case that you talked about i'm just talking about a doctor  health care practitioner at the facility who has had this device that they've already had for a long long time can they continue using it with respect to people at the facility as to whom they've already been using it then the f d a comes along and says it's a band device right this particular device on talking about is one that's been on the shelf in the facility at the time that the regulations adopted can that doctor or the health care practitioner the health care practitioner continue administering that device in the same way it is long as it's the stumbling block that i'm reaching into and i just don't actually know enough care about is whether that preexisting device because it was manufactured with that particular intended use as i take it to treat for self interest and behavior now qualifies as a band device i'm not sure that it would have another legally marketed purpose for that particular device given the way it's manufactured so if i could just change the hypothetical to hopefully give you mansur better if there's a device that is more that is created and marketed today for a lawful purpose such as treating smoking cessation a doctor gets that device and then makes an independent judgment to treat the the f d a if they can effect and i think that depends on whether or not no no it doesn't no it doesn't not not in the question we're asking there is no outside fact involved here there is nobody who said there's another use back at the time we have a real world in which they have these devices that they've made or have illegally at the time they have been using them illegally all wished to treat a particular condition are prescribed prescribed there you can they keep on doing so without asking any other questions your honor and i'm trying to get an answer to it and i'm trying to and i don't think you're trying hard in this can they keep on doing it your honor the stumbling block and i'm running into is whether or on whether whether or not it would be it would come into like a particular prohibition under three hundred and thirty one i assume it is and by and of us can they keep on using it if they had it in the past i think that's going to pretend i'm a particular enfor action or seizure action but generally speaking friday by p c i said maybe it's subject to seizure i get that that there's i think i think your argument would be with any band device even if it hasn't been banned before there's an authority on a three  think it is to see that i get that but just even and that may be controversial but let's just put that to one side suppose there's no seizure the government doesn't want to seize it the question is can the doctor the health care practitioner continue using the device with respect to patients on site in the same way that they had before because if they can and i never read your brief to say that they can't actually this is why the question keeps coming up if they can continue using it that way well then it puts a whole new lens on the inner relationship between banning and three hundred and ninety six because it seems like you've got an answer that says well under three hundred and ninety six it actually doesn't inhibit the it doesn't restrict the practice of medicine in the same way that's been conceived out because the health care practitioner can actually continue using the device in the same way the ban doesn't inhibit that to the same extent that's been posited here that's why we're at think we're trying to suss out an answer to that what exact effect and ninety six have these of the a device that's now banned on some body who already possess the device has already been using it for a particular purpose can that continue to happen and i think generally speaking so long as the device has another law what that's what the part where you're killing the rancher we don't want to know so long as the viruses know we want to know right and i on the facts on the world the real facts are that these doctors have been using this or the medical been using this not for other purposes it has no other purpose there but this that this is the real world which is not a half of that whole can they continue doing what they've been doing consistent with your ban or i'm going to take your answer to be no they can't keep using it i don't think that that's my answer your honor and i don't think that you should impute that in here and so your answer is yes they can keep using it your honor i'm trying to give the correct answer i think i generally agree with heard from boston said which is that generally speaking the off label prescription of a medical device is permitted and that's what three hundred and ninety six recognizes so in this case because you started saying as long as it's got some other use now in this case what this device it does have another use because it can be used for smoking so we've already crossed that so you're it sounds to me like the government's position is that even notwithstanding the ban that for health care practitioners who are on site they can actually continue using this device in the way that they were using it before and i think now there may be a seizure at the end of the day that may be an enforcement and there may be some seizure because of the band but unless it's been  terms of the devices that are already on site those can can it continue to be used in the same way i think that that's certainly true in the only hesitation that i was positing is because we haven't briefed this and that's why i have a hesitation on it because i haven't it down exactly is isolating exactly what the lawfully marketed orphan of it means here because again what we've done here in the banding rule is not try to it is not try to regulate how a particular health care practitioner uses a device off label but rather state whether these devices used for this purpose present a substantial and unreasonable risk of injury that can't be corrected by label and you then say the food would be better continue to use them for the purpose i think if the center is distributing them to their doctors for the purpose that the for this intended use that is banning considered adulterated then generally speaking that that can lead to a seizure action limited and seized and this court and others have repeatedly recognized that the fact that a particular practitioner can't access a drug or device even if they would like to prescribe it doesn't affect the practice of medicine your theory a theory as i understand it is that the f d a has to stress to treat different uses as different devices or purpose or purpose is running throughout the statute including the band provision correct that's correct your honor ok what per decade the the idea of practice of medicine but the thing that was protected with regard to drugs and with regard to devices is was the ability of a physician to take the article or thing that whether it's the drug or the device and it's approved for one use the physician gets to say i am making a medical judgment to prescribe it for a different use now on your theory if the f d a has the ability to slice up those uses and say one of them is really a different device and therefore it can be banned eeriest no practice of medicine that be on your authority no i don't think so your honor i think under the concern that you've laid out there is that the the with the effect of the ban is in the effect of declaring it adulterated for particular use is whether or not that device as marketed for that particular uses tributed for that particular use is widely available in the marketplace so long as the same physical technology right either for the powder in the part of gloves example or the let's let's just assume for the sake of argument that the ability to see is is enough or it could put aside the debate over the downstream consequences let's assume the consequence of banning is that banning for a use is that the physician can't prescribe for that use i don't think that would be the consequence of the seizure action as i understood it is that generally speaking you're looking to the intended use of the manufacturer of the distributor and so long as so the if fact of the ban in making this product adulterated and laugh when and only when its intended use is for treating these severe  issues as opposed to nail biting be the effective that is for a physician can continue using the device but have two intended uses right want one is treating the students disorders and another is treating smoking and nail biting and you your theory is that you can bamboo one use but is that the device becomes adulterated when used for one purpose but not the other and that's exactly what we did in the powder gloves rule was that powder for d surgical gloves can a come in and seize devices that this center continues to use already now prohibited purpose of treating these disorders if i don't know how your answer can be anything other than yes they can do they can seize the device and that's why i was trying to distinguish between a distributor in the physician right if the center is acting as a distributor giving out these devices for the intended use of treating self injury as an aggressive behavior then yes i think that that falls within adulterated it can be seized so that's why so that's why i'm working back because all these provisions interact with each other right so three hundred and fifty one defines what's adulterated and three hundred and fifty one dollars g says it's adulterated if it's a band device and device it's adulterated right dollars and then general practice of medicine exception recognizes that physicians are permitted to prescribe devices even for off label uses and so you generally don't look to the intent of the visitation about how the device is going to be used because that falls within practice of medicine so in this case if if medical professionals at the center continue to use this against the self destructive behavior are they going to be said to see here because  adulterated by being so used based on the practitioners actions no but if the center is acting as a distributor and distributing these devices for particular purpose that f d a has found causes substantial in an unreasonable risks of injury and resulted in their ban and classification as adulterated devices then the center's actions might give rise to a particular enforcement action when used to be sure that it would be your client be said in the court we're not tracking down your beer ban but you are not lawfully entitled to go in and seize their devices well i don't think that that would be before the court but i also think that either selling the device or even transferring the device for free to any entity outside the rothenberg clinic ok but within the rothenberg clinic the the devices are on the shelf the physicians use them one physician is treating a patient and can't come in that day and says to a colleague please please do the treatment or your honor that would that be distribution your honor i don't know because this gets into exactly how three  one k applies in health for sale and i know that's a nuanced area we're not in in force in action right now and if the center or particular doctors want to raise these particular claims which is what i take the reply briefs mainly to be focused on as defenses in a particular enforcement action this port or another can encounter that and deal with it and we can brief it fully but the only here not a sure thing the possibility of an enforcement action because it depends on the particular consequences as we talked about about whether the centers acting as a distributor whether somebody else's and there are cases in which somebody does act as a distributor and encounters a private act like you gave the example of you know a doctor acting as a distributor for and insanitary medical device and you know liability can rise or but we're not in an enforcement context here the only question that's on the table as i understand it in this practice of medicine argument is can f d a promulgated a general rule that's a political will to distributors and manufacturers equally that says this device when it's intended for this kind of use presents serious and unreasonable risks of physical and psychological injury that are well documented through a wealth of evidence that f d a in the expert panel considered and i think that permissible because three hundred and ninety six dollars is a statute that's on the books that has to be contended with now it sounds to me that at least i think and i appreciate that you can't know every hypothetical and know for sure how it would be handled in enforcement action i don't i don't deny the complication of that but it sounds to me that at least your position is that there are some situations in which this notwithstanding that this device has been banned for this use there are at least some situations in which health care practitioners at the facility at the center can continue using that device for the use that it's been used for to date without running afoul of the law and i think that goes with the general proposition that off label use by physicians of an otherwise legally marketed device is covered by the practice of medicine except now that may be an exception that's exceptionally narrow if it turns out that you know even moving your own device from one shelf to another is a self distribution or something i mean at some point the distribution idea swallows the insulation of of the practice of medicine provision and there really isn't permutations there but i haven't so can i just foll is specific or and intended use right yes and the manufacturer and it is always the case that the manuf if you focus on the manufacturer of the device versus the physicians at rothenburg it's always the case that even without any damn the manufacturers all that the manufacturers can do is manufacture the device intending that it be used for the approved use and market it or the approved use right that they can't do anything unapproved use so if your theory of the ban is well you're just restricting the manufacturers but not the doctors in any meaningful way the band really isn't doing anything and i think the band is doing something right to the extent that i mean a fractured distributor is acting in a way that now we are going to only do these for self interest and aggressive behaviors we think this is great for that we're going to market this and an advocate for its use and that way that's something that the f d a f t c a generally covers or alternatively if somebody i guess it would depend on the facts of a particular enforcement action but if somebody is distributing these with wink and not understanding back for dealings of like oh we're facially saying that it's for this price that this but everybody knows it's for the banned adulterated purpose i think that's where it also has teeth in that scenario and i mean it again that's all on the enforcement and of the spectrum and if the court or anybody else has concerns about general practice of medicine i think that that's where they're best felt but f t c eveline it would be back at the beginning when you talk about where you got the man and all when you're talking about regulating there's health care practitioners still have an insulated zone under three hundred and ninety six dollars not withstanding a pre market approval that's where the off label use comes into play and you're on in full force right so there's some insulating work that the united states is doing and the question for us is and for you is what insulating orcas are ninety six doing in a band context now of a broader question for you on this which is we've been talking now for a long time about how this just seems like what we're doing here is we're just considering the statutes and trying to figure out how they enter a light and i'm just wondering does the agency think that its interpretation of these provisions and the way they enter  these always relate to each other in a fairly straightforward fashion and there might be a can but i don't know what that but then like can i just i'm right there when you say you don't think it's a chevron issue i get confused when i hear you don't follow up i say by saying they enter a late and straightforward fashion that still seems to me it doing stache trying her petition you may think the answer is easy but it still seems to me you're doing statutory interpretation and if you're doing statutory interpretation with respect to a provision as to which you have interpretive authority that isn't that chevron land i  guess the question would be whether we're at chevron step two yet and oh no i'm not i'm not talking about that i'm just talking about are we doing chevron at all here are you doing chevron at all here and if you are it sounds to me like your answer is yes you just think that it's easy that you win so you don't need chevron i guess my question is and maybe i've got that wrong if i got that wrong tell me but it sounds to me like that's what you're saying and what i don't understand is if that's where you are then why wouldn't you just invoke it anyway as i as i think the department has done for decades when it's have chevron authority is always argued well i think we went anyway but chevron makes it easy because all all our interpretation has to be is reasonable now i  just want to make sure that i'm not missing something in thinking that this is a case in which that kind of argument could be made we thought that the case was fairly straightforward enough that we didn't need chevron i'm not resisting the application of che and then but what wyatt if you think that the case is easy enough that you don't need chevron why not use it if it would help you anyway it doesn't just make it easier you're on everything for all the reasons in our brief that this the court i am considering it now and that's why i'm saying this is an issue a little late in the day yes your honor like i said we thought that we went on this issue just in a pretty straightforward fashion one more question for me which  these and now i'm quoting already in commercial distribution and an devices already sold to the ultimate user as well as devices sold or commercially distributed in the future and given that isn't if a little bit rich for you to say that if they're  concerns about the practice of medicine don't really apply because the ban is only going to have teeth as applied to the initial sellers but not as supplied to the downstream doctors knowing your honor as is we explain right you're still in those instances looking to what the intended use was on the distributor and the manufacturer that's a problem device right and the problem i think the problem i don't think it is a problem your honor if you look to any side of this house report in the brief h r rep number ninety four dash eight hundred and fifty three it's the congress report from when they pass a medical device act and there that congress is clearly saying we expect that the secretary when a particular item has back to your what i think is your primary bans which is that the banning authority allows you to pick off individual uses but it tends to for e an alternative to fance that this is really no big deal because the consequence of the ban really doesn't impair retail practitioners if  practitioner once to access an electrical stimulation device that's been manufactured and marketed for another lawful purpose like smoking cessation and then make an independent medical judgment that it's going to be best used for my particular patient in a different way that's something that falls within the general practice of medicine when made in that in that context and that's why a f d a general banding rule doesn't run afoul of these concerns and if it's banned under the ban we have here in the trying to be dr continues to use it well the doctor standing in the danger of having the savior briefly and that's why i think the answer depends on a particular fact and that's what i'm trying to here that's why i use the term possibility instead of splendid would definitely have been right so if the only intended use of this device for the treating something that's all going after using it for is for self destructive behavior you've got that fact on the table to make up a different gate your honor if that was the only purpose then i think it falls within the general practice of medicine and you don't look to the adulteration from that if the intent otherwise is coming from a distributor in the manufacture then i don't then i think it i subject to the general prohibitions and therefore weight completely and can i just i just want to button one last thing which is we've got decisions that say that the government's decision not to invoke chevron doesn't affect a waiver of chevron but that presupposes from our purposes that chevron would otherwise apply had the government involved it i just want to make sure you don't have any reason as the government to tell us that chevron doesn't apply here i'm not here today to tell you that chevron doesn't apply ok let me make sure my colleagues don't have any additional questions for you yes ok thank you mr aguilar each of the petitioners counsel i believe has one the use of these devices and it specifies that for a complaint state is thirty days except for those words which are currently being used and for those  which describes as a prohibited act the introduction or delivery for introduction into interstate commerce of adulterated food drug or device there is a separate statute criminal context i think were gendered sciences might have been one of those cases where there was a criminal prosecution and if i take your point about risk but it does seem to me you would have a pretty good argument church no matter how it shares and uses and moves around the devices of the san or it's not introducing them into interstate commerce that's true have one further observation to make if i can make it really quickly well i think that what the f b i is theory does is it is it would create just gaping exception to section and ninety six and what this court said just last week in the genus patient apply here which is that and they court quote if the supreme court you know generally make fundamental changes with subtle moves so the statute isn't accomplishing anything the band i should say isn't accomplishing anything but the f d a would use because of all these uncertainties against j r c and the health care practitioners there to frighten them into not using it because of these potential criminal liability and everything else so that the band doesn't meet the requirements of the statute it should not be allowed to stand it shouldn't also be allowed to harm these petitioners who need this treatment to survive and allow the f d a to harass them and threaten them to stop using the treatments so you're right if that's the one question right right as we close which is d and you may not know the answer this but does this statutory and regulatory scheme allow for the potential target of an action to seek advisory and advisory opinion on whether the actions that they're going to undertake falls within the zone of what's private you know anything no not to me not to my knowledge in the end you know it's clear in the record the f d a is treatment of these petitioners has been harassment unfairness all they want to do is stop jerry from using this treatment on these clients who needed to survive in this bin needs to be said to protect ok thank you counsel thank you to all counsel this morning will take this case under submission