[00:00:01] Speaker 00: Phase number 20-1087 et al. [00:00:04] Speaker 00: The Judge Rotenberg Educational Center, Inc. [00:00:06] Speaker 00: Petitioner versus United States Food and Drug Administration et al. [00:00:10] Speaker 00: Mr. Stern for the petitioners, Louis Aponte et al. [00:00:14] Speaker 00: Mr. Flamia for the petitioner, the Judge Rotenberg Educational Center, Inc. [00:00:18] Speaker 00: Mr. Aguilar for the respondents. [00:00:24] Speaker 03: Good morning, counsel. [00:00:25] Speaker 03: Good morning. [00:00:25] Speaker 03: Mr. Stern, please proceed if you're ready. [00:00:27] Speaker 02: Thank you. [00:00:29] Speaker 02: Your Honor, this case involves FDA's total prohibition on using a device long approved by FDA for the treatment of the most horrific, debilitating, life-threatening, and often catastrophic conditions. [00:00:44] Speaker 02: The ban applies to a total of 55 persons in the United States. [00:00:49] Speaker 02: The patients who receive it are those who have proved resistant, the word is refractory, to all other therapies, but have seen their health restored, their lives changed or saved through this treatment. [00:01:04] Speaker 02: To sustain its about face under the APA and the banning provision of the FDCA, FDA must have considered all important factors, aspects of the problem, specifically based its decision on all available data and information, [00:01:24] Speaker 02: and provided a reasonable and plausible explanation for reversing a policy on which patients have depended for years. [00:01:34] Speaker 02: FDA has failed in every one of these respects. [00:01:38] Speaker 02: First, FDA concedes that there is a population of patients with these conditions who are refractory to all other therapies. [00:01:49] Speaker 02: to comply with the criteria of the banning statute, it must explain why it now concludes after 30 years of reliance that the risks of the device so outweigh its benefits that it is unreasonable to continue using it even for these persons who have nothing else. [00:02:14] Speaker 02: Such a reason. [00:02:15] Speaker 06: Are you not conceding that they can do this at all? [00:02:20] Speaker 06: It really thought your base font was under section 396 that they simply could not do what they're doing here, that it's practicing medicine when they base a, an attempted banning on the use. [00:02:33] Speaker 06: Am I missing? [00:02:35] Speaker 06: Have you conceded that point or are you? [00:02:37] Speaker 06: Oh, not at all, your honor. [00:02:38] Speaker 02: I'm going to get to it. [00:02:39] Speaker 06: Shouldn't that be where we start to examine as to whether they can do it at all or not? [00:02:45] Speaker 02: Well, I'm happy to start there. [00:02:47] Speaker 02: I wanted to get this so that I could show how they have not even applied correctly the standards which they admit they have under the banning criteria. [00:03:03] Speaker 06: Well, if you are correct on 396, then those don't matter, do they? [00:03:08] Speaker 02: You're right. [00:03:10] Speaker 02: Absolutely. [00:03:10] Speaker 02: And 396 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 this ban was enacted. [00:03:27] Speaker 02: was that the decision as to whether to apply this particular therapy to any particular patient who had tried all other therapies was up to the health care practitioner, up to the doctor. [00:03:46] Speaker 02: that FDA is the gatekeeper for what devices shall be allowed to go into commerce, but it is the medical practitioner that decides what conditions and what patients may get that treatment. [00:04:05] Speaker 02: And this, of course, we have here a reversal of position. [00:04:12] Speaker 02: In 1999, Congress passed Section 396, which was a statutory form of the off-label doctrine which had existed since 1938, the very inception of this FDCA. [00:04:32] Speaker 03: Can I ask a question about this part of the argument, which is [00:04:35] Speaker 03: the interrelationship between 396 and the banning provision. [00:04:40] Speaker 03: So as I understand your position, it would mean that essentially the agency has an all or nothing power in terms of banning. [00:04:48] Speaker 03: It either has to ban the device in all its uses, or it can ban the device in none of them. [00:04:54] Speaker 03: And for now, I'm just going to assume that we're talking about the same device. [00:04:57] Speaker 03: when, for example, this device is used to curtail smoking or is used to curtail self harm. [00:05:03] Speaker 03: Let's just assume, I think there's an argument that it's not the same device, but let's just assume it's the same device. [00:05:08] Speaker 03: 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. [00:05:18] Speaker 03: And my question is, why would Congress [00:05:22] Speaker 03: have wanted to do that. [00:05:24] Speaker 03: 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 supremely efficacious for other uses, then what's the rationale by which Congress would have said, well, still, the agency's stuck. [00:05:45] Speaker 03: 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. [00:05:52] Speaker 02: Well, this is the decision that Congress made from the beginning, what was carved out was what is what form of regulation is up to the FDA, and what form is up regulation is up to the states, and is up to is up to the practice of medicine. [00:06:11] Speaker 02: And this was a dividing line, both for drugs and for devices. [00:06:19] Speaker 02: And if there is a device that you have allowed to go into and to be used and to be distributed in commerce, and if it has a proper use, [00:06:28] Speaker 02: If it has whatever minimum amount of effectiveness or safety that is enough to put it in commerce, we will leave it to the physicians, the hospitals, the experts on individualized retail medicine [00:06:44] Speaker 02: to decide is this good for this for this patient. [00:06:49] Speaker 02: That doesn't mean that there's no regulation. [00:06:51] Speaker 02: It just means that it's not up to FDA to make that. [00:06:55] Speaker 06: Yeah, I would have thought someone in the case would have decided our decision and American Bar Association versus Federal Trade Commission. [00:07:02] Speaker 06: where we collected cases that where federal government is intending to intrude into the areas of regulation that have previously been those of the been left in the states under the federal system that congress should be expected to expressly have said so or where they not only have expressly not said that they're going into the regulation of practice of medicine as a practice of law and the other case practice of medicine uh [00:07:30] Speaker 06: Then I don't even not expect to said they want the federal government to take it over. [00:07:34] Speaker 06: They said not to. [00:07:35] Speaker 06: They're saying here that practice of medicine is not going to be regulated by the FDA, aren't they? [00:07:41] Speaker 02: That's correct. [00:07:43] Speaker 02: And, you know, it's it's [00:07:47] Speaker 02: It's important to look at the text of the statute, the text of the statute refers specifically, it's 396, it says, you know, not withstanding anything else in this chapter, and that would include the banning statute. [00:08:03] Speaker 02: It's also important to realize what was the context of the banning statute. [00:08:08] Speaker 02: The banning statute was not talking about some kind of a device that had previously been approved by the FDA, that was supported by some body of scientific evidence that has been used with the approval of the FDA for many years. [00:08:25] Speaker 02: It was talking about devices that had no arguable claim to [00:08:30] Speaker 02: validity, the Xeret applicator, the Virilium tube, these kinds of things. [00:08:38] Speaker 03: And when the banning statute came out... But do you think that the agency was barred from the use specific ban on [00:08:54] Speaker 03: powder for the surgical uses. [00:08:59] Speaker 03: It was banned for surgical uses, but the same powder was not banned for other uses. [00:09:04] Speaker 03: Do you think that the agency didn't have the power to do that? [00:09:13] Speaker 02: They banned surgical gloves. [00:09:17] Speaker 03: And the powder, but we can talk about the gloves too, but yeah. [00:09:20] Speaker 02: And they are in examining gloves. [00:09:23] Speaker 02: And they contrasted that with, the contrast was condom. [00:09:30] Speaker 02: And I think you have to look at, you can say that a surgical glove is different than a condom. [00:09:39] Speaker 03: I thought that was about the powder. [00:09:40] Speaker 03: I thought it was the decision there was about the powder and the powder is the same, as I understand it. [00:09:46] Speaker 02: That's right. [00:09:47] Speaker 03: But it's- So then is it your position that the FDA was barred from doing that? [00:09:54] Speaker 02: No, I'm not. [00:09:55] Speaker 02: I'm saying that with the FDA- Well, first of all, that never was contested. [00:10:02] Speaker 03: No, but I'm asking you. [00:10:03] Speaker 03: Is the upshot of your argument that what the FDA did with the powder, which is to allow it for some uses but to ban it for others, is something that the FDA lacked authority to do? [00:10:16] Speaker 02: They, I, I think I would take that position if necessary, but no court has ever held that they had that power. [00:10:23] Speaker 06: Have they that that hadn't been tested in the court. [00:10:26] Speaker 02: It is distinguishable from the situation. [00:10:28] Speaker 06: You have the distinction for a moment. [00:10:30] Speaker 06: Is it not correct that the FDA says they can do that, but no court has ever held that. [00:10:36] Speaker 02: That's correct. [00:10:37] Speaker 06: Okay. [00:10:37] Speaker 02: Thank you. [00:10:39] Speaker 02: This statute clearly applies to our situation. [00:10:49] Speaker 02: What the statute says is that nothing in the chapter shall limit or interfere with the authority of a healthcare practitioner to prescribe or administer any legally marketed device for any condition or disease. [00:11:04] Speaker 03: Now that was enacted in 1999 on the sentence in the statute to this section shall not limit any existing authority, the secretary to establish and enforce restrictions on the sailor distribution that that sentence has been there to you right. [00:11:19] Speaker 02: That's right, but restriction is not a band. [00:11:24] Speaker 03: Restriction and restriction. [00:11:26] Speaker 03: Well, just in ordinary English, would you say that a ban is a restriction? [00:11:30] Speaker 02: It could be, but there is a definition of restriction in the FDCA. [00:11:34] Speaker 02: And it talks about things like there is a restriction here, actually. [00:11:38] Speaker 02: It has to be prescribed by a doctor. [00:11:40] Speaker 02: There can be other restrictions. [00:11:41] Speaker 02: That's what they're talking about when they talk about restrictions. [00:11:44] Speaker 02: And if you construed restriction to mean a ban, [00:11:49] Speaker 06: You know, then you would be talking about something that then you are the statute would be meaningless at that point, wouldn't it? [00:11:58] Speaker 06: FDA could do whatever it wanted to. [00:11:59] Speaker 02: That's right. [00:12:01] Speaker 02: Congress was specifically concerned with the fact that in 1999, FDA had suggested it could do what it's doing here. [00:12:10] Speaker 02: And that is specifically what caused the, that it was suggesting that it could ban a specific use for an approved device. [00:12:21] Speaker 02: And Congress passed this statute in order to prevent FDA from doing that. [00:12:27] Speaker 03: I think Judge Katz was asking the question. [00:12:29] Speaker 03: I think your audio cut out for a second. [00:12:31] Speaker 04: I'm sorry. [00:12:32] Speaker 04: On that question, you're putting a lot of weight on the word restrict, a restriction versus a ban. [00:12:40] Speaker 04: But that sentence goes on to talk about sale distribution or labeling and isn't a perfectly good separate [00:12:53] Speaker 04: answer to the question that in the context of this 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 sale distribution or labeling does not refer to the interactions between doctor and patient. [00:13:20] Speaker 02: I would agree with that, Your Honor. [00:13:22] Speaker 02: And I think that this is specifically what this statute was enacted in order to what the FDA is doing here to prevent. [00:13:35] Speaker 06: And let me point out that- And in this case, where we have this order, we have this decision from the FDA that goes into that transition discussion, it rather plainly is contemplating the practice of medicine, wouldn't we say? [00:13:46] Speaker 02: Yes, Your Honor, absolutely. [00:13:49] Speaker 02: And note this, that on the very heels of the enactment of the statute, FDA told JRC, you are exempted by the practice of medicine. [00:13:59] Speaker 02: And they told them that for 10 straight years until they started going down this road toward this rule. [00:14:06] Speaker 02: And at that point, they said, we have just learned that it doesn't apply. [00:14:09] Speaker 02: They didn't explain how it was that they had now reasoned that it does apply. [00:14:14] Speaker 02: And as Judge Santel pointed out, that their interpretation would cause this enormous, give them really limitless discretion to reopen the approval of almost any device. [00:14:31] Speaker 03: And what they- I don't wanna unnecessarily cut you off when you're echoing a point that Judge Santel has made for sure, but you do have another colleague on your same side. [00:14:41] Speaker 03: Let me just make sure that, [00:14:42] Speaker 03: My colleagues don't have any additional questions for you at this time. [00:14:47] Speaker 03: Nothing further. [00:14:48] Speaker 03: We don't? [00:14:48] Speaker 03: Then thank you, Mr. Sherman. [00:14:50] Speaker 03: Let's hear from Mr. Flamier. [00:14:54] Speaker 01: Thank you, Your Honors. [00:14:55] Speaker 01: May it please the Court? [00:14:57] Speaker 01: My name is Michael Flamier, and I represent the Judge Rotenberg Educational Center. [00:15:02] Speaker 01: I certainly would agree that by banning only two uses of a device, use for self-injury, severe self-injury, and severe aggression, [00:15:13] Speaker 01: But specifically saying it can be used for other uses such as smoking, trying to stop smoking or nail biting. [00:15:21] Speaker 01: This is the practice of medicine. [00:15:22] Speaker 01: This is the FDA getting involved in the practice of medicine. [00:15:25] Speaker 01: And smoking itself is a self-injurious behavior. [00:15:28] Speaker 01: So the difficulty in enforcing this illegal use of the ban just raises other problems. [00:15:35] Speaker 01: And the purpose of the banning statute [00:15:38] Speaker 01: was to take truly hazardous and deceptive devices off the market. [00:15:43] Speaker 01: It's only been used three times in almost 40 years. [00:15:47] Speaker 01: It was not promulgated for the purposes of making fine slices of what doctors can do with the device and cannot. [00:15:56] Speaker 01: And with respect to the powder question, it seemed to me that powder wasn't a component part of those particular gloves. [00:16:03] Speaker 01: And so the entire device was banned. [00:16:08] Speaker 01: You know, the GED is clearly not hazardous. [00:16:12] Speaker 03: But that would be true. [00:16:13] Speaker 03: I mean, you could, you might be able to deal with powder that way. [00:16:16] Speaker 03: I'm not sure that works actually, but there's all kinds of examples like the popsicle stick. [00:16:21] Speaker 03: There's all kinds of examples where the upshot of your position is that it's an all or nothing proposition. [00:16:26] Speaker 03: It has to be banned even as to efficacious uses. [00:16:30] Speaker 03: And 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. [00:16:39] Speaker 01: Your honor, the statute 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. [00:16:53] Speaker 01: Again, only been used two other times in history, and there was really no dispute about the hazards and the deception of those devices. [00:17:00] Speaker 01: In this case, the GED device is not hazardous. [00:17:03] Speaker 01: It's unpopular. [00:17:05] Speaker 01: It's unpopular with advocates who don't like the problem. [00:17:08] Speaker 06: I don't really think you're coming to grips with Chief Judge's question on that. [00:17:13] Speaker 06: Isn't it your position? [00:17:15] Speaker 06: Isn't it necessarily your position? [00:17:22] Speaker 03: Oops, I think you may have muted Judge Santel. [00:17:27] Speaker 03: Yeah, he did. [00:17:29] Speaker 03: Judge Santel, I think you're on mute. [00:17:31] Speaker 03: We want to make sure we catch your question. [00:17:35] Speaker 04: I don't think he's heard you. [00:17:38] Speaker 03: I'm sorry. [00:17:39] Speaker 03: Judge Santel, I think you're muted. [00:17:52] Speaker 06: OK. [00:17:52] Speaker 03: There. [00:17:53] Speaker 06: Now, my brother, I got muted. [00:17:54] Speaker 06: Now, I'm unmuted again. [00:17:55] Speaker 03: Yes, yes, yes. [00:17:56] Speaker 06: You hit something on my keyboard when I was moving my file around. [00:18:00] Speaker 06: Isn't it? [00:18:00] Speaker 06: I don't think you're coming to grips with what the chief judge was asking. [00:18:05] Speaker 06: doesn't it have to be your position exactly what the chief is positing on a phrase a little differently that the FDA is authorized to ban devices, but they're not authorized to interfere in the practice of medicine and that the banning the total banning is what they're authorized to do. [00:18:25] Speaker 06: But as far as the use of them, that's the practice of medicine and Congress expressly took that out of their power. [00:18:33] Speaker 06: So you're [00:18:34] Speaker 06: avoiding saying yes when he asked you isn't that your interpretation but isn't it in fact your interpretation. [00:18:40] Speaker 01: Yes it is your honor in fact the statute specifically says quote unquote banned devices so yes. [00:18:46] Speaker 01: Excuse me for talking while I was muted there a while ago. [00:18:49] Speaker 01: Well I was I was worried about how hard the question might be your honor. [00:18:58] Speaker 01: So again, the GED is not hazardous. [00:19:01] Speaker 01: It's simply unpopular with advocates who don't like the thought of it. [00:19:05] Speaker 01: But there is no legal basis to ban a device to give the advocates and their sympathizers peace of mind. [00:19:12] Speaker 01: And to do so would literally rain hell on our clients who are innocent and thriving and who deserve to keep their lifesaving treatment and their only hope for health and happiness. [00:19:24] Speaker 01: This ban, the FDA's ban, the FDA has completely undermined the legality of this ban with its four major concessions. [00:19:34] Speaker 01: Number one, first, FDA concedes that severe self injury and abuse, and I'm quoting the FDA, is a devastating condition that leads to serious permanent bodily injury and repeated physical assaults. [00:19:46] Speaker 01: Second, FDA concedes that there are patients with severe life threatening self injury and abuse who cannot be successfully treated [00:19:54] Speaker 01: with positive interventions and drugs or any other alternative treatment. [00:19:58] Speaker 01: So three, the FDA has conceded that the risk caused by banning ESDs for self-injury and aggression for this refractory population, our petitioners with no other effective treatment puts them in the most dangerous risk imaginable, the imminent and inevitable loss of life and limb. [00:20:18] Speaker 01: And finally, fourth, [00:20:20] Speaker 01: the evidence of actual side effects of ESDs that FDA identifies in the record, even if true, and we dispute them, are not serious illness or injury, and therefore do not satisfy the banning statute, and they are not comparable to the loss of life and limb, which is the condition our petitioners would be in without ESDs for self-injury and aggression. [00:20:42] Speaker 01: And to try to save their ill-fated ban, FDA makes a patently arbitrary and capricious [00:20:49] Speaker 01: and most desperate finding that the GED, the only ESD currently being used to treat self-injury and aggression and use it only one facility, they claim it provides no benefit at all. [00:21:01] Speaker 01: FDA makes this baseless claim, giving no consideration to all of the hundreds of decisions and the hundreds of Massachusetts court cases, finding that GED saves lives and causes no harm where all other treatment fails. [00:21:15] Speaker 01: Further still, [00:21:16] Speaker 01: The dozens of families of the people currently receiving the GED treatment have all told the FDA in writing that for my child, without the GED, my child will lose her health, will lose her happiness, will lose her freedom, and will return to her previous life of no effective treatment, constant pain and mutilation, blindness, sedation, restraint, and a locked ward, and likely early death. [00:21:42] Speaker 01: No quality of life. [00:21:44] Speaker 01: Not being able to satisfy the standard of the banning statute, FDA engages in a multitude of other arbitrary and capricious acts to try and justify its predetermined HHS-ordered conclusion to ban ESDs for self-injury and aggression. [00:21:59] Speaker 01: FDA wrongfully enters the decades-long debate among health care practitioners about how to best treat severe self-injury and abuse. [00:22:09] Speaker 01: But that is practice of medicine, which is statutorily not FDA's jurisdiction. [00:22:13] Speaker 01: FDA is using a banning statute to instruct health care practitioners that you can use ESDs to treat smoking or nail biting, but not self-injury. [00:22:25] Speaker 01: FDA is wrongfully playing doctors. [00:22:28] Speaker 01: FDA uses illegal standards that FDA has never used on any other device, such as the benefit must be durable and curative, and that the need for continuous use of the device means [00:22:39] Speaker 01: it is not effective at all. [00:22:40] Speaker 01: Well, what about pacemakers? [00:22:42] Speaker 01: What about internal defibrillators, knee replacements that mitigate harm just like the GED does? [00:22:48] Speaker 01: FDA says that only randomized controlled trial research is credible and applicable, not the real world evidence, single case designs, clinical research, non-clinical data that FDA relies on to clear hundreds of devices. [00:23:03] Speaker 01: FDA won't even consider the hundreds of peer reviewed scientific articles approving [00:23:09] Speaker 01: Skinshark because the writer might have been biased, might not have reported adverse events, because one of the writers was on the editorial board, all insignificant maybes that could be applied to any scientific literature. [00:23:24] Speaker 01: And the GED label, which the FDA approved when it cleared GED for treating self-injury in 1994, now suddenly no longer is adequate, despite FDA [00:23:36] Speaker 01: approving other devices with similar labels that require other types of treatments to be tried first before using the device on a refractory patient, like ECT. [00:23:48] Speaker 01: There is just no evidence in the record that the current label isn't working. [00:23:52] Speaker 01: And it is, as you can see from the court findings. [00:23:55] Speaker 01: FDA won't consider any of the doctors, panel members, judges, parents who have told FDA that the GED treatment is effective, safe, and the only treatment that will keep the refractory patient safe and healthy. [00:24:05] Speaker 01: Unable to satisfy the banning statute standards, FDA also arbitrarily and capriciously claims that pain is an illness and injury under the statute. [00:24:15] Speaker 01: Your honors, pain is a sensation. [00:24:18] Speaker 01: It is not an illness or an injury. [00:24:20] Speaker 01: 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. [00:24:28] Speaker 01: For these refractory patients, the petitioners, the pain of severe self-injury and aggression will not stop it. [00:24:35] Speaker 01: They will engage in hundreds of these behaviors, destroying their body. [00:24:39] Speaker 03: So under your argument, your time's about to end, but let me just ask you one last question and just answer this one. [00:24:47] Speaker 03: If FDA, just put aside your argument about uses and devices. [00:24:51] Speaker 03: We're just talking about a device. [00:24:53] Speaker 03: And the only thing the device does is cause excruciating pain. [00:24:56] Speaker 03: Your argument is the FDA is barred from banning that device because the consequence of it is all it does is cause pain, which is not an injury. [00:25:04] Speaker 01: It has to weigh the risks and benefits. [00:25:06] Speaker 01: And yes, pain is not an illness or injury. [00:25:09] Speaker 01: And pain is involved in hundreds of devices, Europe. [00:25:13] Speaker 03: Yeah. [00:25:13] Speaker 03: OK. [00:25:14] Speaker 03: All right. [00:25:14] Speaker 03: I think we have your argument. [00:25:16] Speaker 03: Make sure my colleagues don't have questions for you. [00:25:18] Speaker 03: Thank you, Mr. Flamio. [00:25:20] Speaker 03: Why don't we hear from the government, Mr. Aguio? [00:25:24] Speaker 05: Thank you, Your Honor. [00:25:25] Speaker 05: Daniel Aguilar for the federal respondents. [00:25:28] Speaker 05: I'd like to just briefly address the arbitrary and capriciousness challenge. [00:25:32] Speaker 05: Actually, would you mind starting with the statute? [00:25:35] Speaker 05: Sure. [00:25:35] Speaker 05: We can go straight to their argument about the practice of medicine. [00:25:38] Speaker 05: So I think that their primary argument is that either under a general exception to the practice of medicine that the FDCA incorporates or in 396 particularly, [00:25:48] Speaker 05: FDA is prohibited from banning the particular use of a device. [00:25:53] Speaker 05: I think that's wrong for a couple of different reasons. [00:25:56] Speaker 05: Initially, both because the FDCA, both overall and in 360F, recognizes that what a device is depends on its intended use. [00:26:06] Speaker 05: And secondly, that when it's not just that a ban impacts the practice of medicine, as this court recognized, I think it was in regenerative medical, [00:26:15] Speaker 05: right FDA largely acts in regulating the distribution and manufacturing of drugs and devices and FDA rules with respect to those. [00:26:24] Speaker 06: Well that's exactly the problem that that's how the FDA acts is in the district the commerce in the devices and medications and such and 396 seems to specifically say that's what you're limited to you can't practice medicine you can't control the practice of medicine sure so why isn't what you've done here today [00:26:45] Speaker 06: exactly in the finance of Congress's instruction? [00:26:50] Speaker 05: Because I guess it depends on the interaction that a ban is going to have on then the enforcement provision, the prohibited acts under the DCA. [00:26:59] Speaker 05: So if I could just explain that relationship. [00:27:01] Speaker 05: So when a device is banned, it's then considered adulterated under Section 351 G. [00:27:08] Speaker 05: And then section 331 of the FDCA then says what prohibited acts are. [00:27:14] Speaker 05: So for example, 331A says you're not allowed to introduce an adulterated device into interstate commerce. [00:27:20] Speaker 05: Subsection C says you're not allowed to receive it. [00:27:23] Speaker 06: And- Correct me if I'm wrong, but doesn't all of that go to the device, not to the use of the device? [00:27:29] Speaker 06: Well, so- You're trying here not to man, and the chief has made this point several times when talking to the other lawyers. [00:27:35] Speaker 06: You're talking here about a ban, not of the device. [00:27:38] Speaker 06: But of the use of the device. [00:27:39] Speaker 05: Well, a device has to be intended for a particular use, right? [00:27:43] Speaker 06: So yes, it does. [00:27:44] Speaker 06: OK, so it does. [00:27:46] Speaker 05: It does. [00:27:46] Speaker 06: Nonetheless, when you have banned the device, you've banned the device. [00:27:51] Speaker 06: You are trying to regulate its use after it has been transported. [00:27:55] Speaker 06: And so you're trying to regulate its use. [00:27:58] Speaker 06: That use seems to come exactly within 396, doesn't it? [00:28:01] Speaker 05: Well, no, I don't think so, your honor. [00:28:03] Speaker 05: So for example, if somebody was to manufacture, let's say a company starts up tomorrow to manufacture and distribute these devices and say, right, the only way that we're marketing 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-injurious and aggressive behavior. [00:28:21] Speaker 05: that would be a banned device. [00:28:23] Speaker 05: If some other company comes in the market tomorrow and says, the only thing that we're doing, the only thing that we're marketing this for is for smoking cessation or something else. [00:28:31] Speaker 05: That is not a banned device under that issue. [00:28:33] Speaker 06: Even though we're precisely the same device. [00:28:36] Speaker 05: Yes. [00:28:36] Speaker 05: And that's true. [00:28:37] Speaker 06: What you're regulating is not the device. [00:28:40] Speaker 06: It's the use of the device. [00:28:42] Speaker 06: If you are permitting the device to come on the market, the whole transition section of your FDA opinion, but the appeal from, [00:28:50] Speaker 06: It seems to be with that in mind that what we're dealing with here is fraction medicine. [00:28:55] Speaker 05: No, your honor. [00:28:56] Speaker 05: Generally speaking, when FDA is classifying different medical devices, it looks to their intended use. [00:29:02] Speaker 05: So we give a couple of examples of this. [00:29:04] Speaker 05: For example, some knee prosthetics are going to be class two when they're used to treat particular arthritic conditions because of the risk. [00:29:13] Speaker 06: Nonetheless, nonetheless, when you are talking about what you're regulating here, what you're really going to is not the device, but the use of the device, isn't it? [00:29:23] Speaker 06: Yes, your identical device could still be legal, but for your regulation to be used, is that not correct. [00:29:30] Speaker 05: And that's true generally with devices, if I could just complete the thought because I think it does go to answer your honors question. [00:29:36] Speaker 06: Right thing off labeled use does not apply to. [00:29:41] Speaker 06: devices, but only to medications or no, that's not what we're saying, your honor. [00:29:45] Speaker 06: So it sounds like what you're saying. [00:29:47] Speaker 05: It is, it is not what we're saying. [00:29:48] Speaker 05: And if I can be clear about this, the prohibited acts and three, three, one, generally speaking are targeted at manufacturers and distributors, not at a physician's off label use. [00:29:59] Speaker 05: And that's what section three 96 recognizes. [00:30:01] Speaker 03: So is that also true? [00:30:03] Speaker 03: Does ban come with an off label? [00:30:05] Speaker 03: So for example, if a healthcare practitioner at [00:30:09] Speaker 03: petitioner's facility wants to administer this device. [00:30:18] Speaker 03: Can they do that for a device that they already have? [00:30:20] Speaker 03: It's not newly on the market. [00:30:22] Speaker 03: It's not newly distributed. [00:30:23] Speaker 03: It's been in their possession for 40 years. [00:30:26] Speaker 03: can they use that on somebody who's at that facility? [00:30:30] Speaker 05: I think that's going to depend on the particular factual scenarios there and if I can explain why. [00:30:36] Speaker 05: Okay. [00:30:37] Speaker 05: For a device that has been manufactured and distributed already for this intended use, I think it comes within the band device. [00:30:44] Speaker 03: For a device that is not... Okay, but it might come within the band device, but what does that mean in terms of 396? [00:30:50] Speaker 03: So I think then the healthcare practitioner is not able to prescribe or administer that device. [00:30:56] Speaker 05: No. [00:30:56] Speaker 05: So if I can be clear, because there are other cases that could potentially be implicated by how this how this gets divided. [00:31:02] Speaker 05: So for example, under 396 general practice of medicine issues. [00:31:07] Speaker 05: Practitioners who have a practitioner-patient relationship can prescribe off-label devices, even if it's for something that's not otherwise approved. [00:31:17] Speaker 05: Can prescribe, right? [00:31:18] Speaker 05: Yes, and as long as it's an otherwise legally marketed device, yes, they can do that. [00:31:23] Speaker 05: Now, and I want to be clear because this has potentially outside implications here when a physician is acting as a manufacturer or distributor, there can be particular consequences if I can just give one example to explain why there was a case out of the ninth circuit where a doctor. [00:31:39] Speaker 05: was reusing single-use needle guides for biopsies and then distributing that to people in their practice. [00:31:46] Speaker 05: The Ninth Circuit upheld a 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 for it, that doesn't come within- Let's get out of the hypotheticals and come back to this one that the chief's asking you about. [00:32:03] Speaker 06: In this case, could a practitioner at the center [00:32:08] Speaker 06: prescribe this use, continue to prescribe this use on the devices that they have there. [00:32:14] Speaker 05: And I think it depends on the particular factual scenarios. [00:32:16] Speaker 06: No, don't tell me it depends on anything. [00:32:17] Speaker 06: You tell me, is it possible for the doctor to do that first? [00:32:21] Speaker 06: Then you can explain your answer. [00:32:23] Speaker 05: I think generally, yes, if it's within a legitimate patient practitioner relationship and it's otherwise a legally marketed device, yes. [00:32:31] Speaker 06: Let's take the device we have here, the exact scenario we have here. [00:32:35] Speaker 06: Don't give me any ifs. [00:32:37] Speaker 05: Your honor, the reason that I can't give you a particular answer on that is that this administrative record that we have in this case. [00:32:45] Speaker 03: Let me ask it this way, because I think we have to understand exactly how 396 potentially inhibits people at the facility from using devices that are already there. [00:32:59] Speaker 03: I'm not talking about distribution to another doctor. [00:33:02] Speaker 03: I'm not talking about that. [00:33:03] Speaker 03: So you can take that one off the table. [00:33:05] Speaker 03: All I'm talking, because as I understand it, that's the complication that's raised by the Ninth Circuit case that you talked about. [00:33:10] Speaker 03: I'm just talking about a doctor or a healthcare practitioner at the facility who has had this device that they've already had for a long, long time. [00:33:22] Speaker 03: Can they continue using it with respect to people at the facility as to whom they've already been using it? [00:33:29] Speaker 03: Then the FDA comes along and says, it's a banned device. [00:33:33] Speaker 03: The particular device I'm talking about is one that's been on the shelf in the facility at the time that the regulations adopted. [00:33:41] Speaker 03: Can the healthcare practitioner continue administering that device in the same way? [00:33:48] Speaker 05: As long as it's, so the stumbling block that I'm reaching into and I just don't actually know enough here about is whether that pre-existing device because it was manufactured with that particular intended use as I take it to treat for self-injurious behavior now qualifies as a banned device. [00:34:04] Speaker 05: So I'm not sure that it would have another legally marketed purpose for that particular device given the way it's manufactured. [00:34:10] Speaker 05: So if I could just change the hypothetical to hopefully give you an answer better. [00:34:14] Speaker 05: If there's a device 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 a particular patient. [00:34:29] Speaker 06: I still want an answer in the real world. [00:34:31] Speaker 06: If a doctor at this center has the device and has prescribed it for a patient, can they continue doing so now after the FDA has taken this action? [00:34:44] Speaker 06: And I think that depends on whether or not. [00:34:46] Speaker 06: No, it doesn't. [00:34:48] Speaker 06: No, it doesn't. [00:34:48] Speaker 06: Not in the question we're asking you. [00:34:50] Speaker 06: There is no outside fact involved here. [00:34:53] Speaker 06: There is nobody who said there's another use back at the time. [00:34:56] Speaker 06: We have a real world in which they have these devices that they may have illegally at the time. [00:35:04] Speaker 06: They have been using them legally all this time to treat a particular condition or prescribe their use for a particular condition. [00:35:12] Speaker 06: Can they keep on doing so? [00:35:13] Speaker 06: without asking any other questions. [00:35:16] Speaker 05: Your honor, I'm trying to give an answer to it. [00:35:19] Speaker 06: I don't think you're trying hard enough. [00:35:22] Speaker 05: Can they keep on doing it? [00:35:24] Speaker 05: Your honor, the stumbling block that I'm running into is whether or not that particular device [00:35:30] Speaker 05: if it was only marketed initially and distributed. [00:35:34] Speaker 05: Assume it was only marketed and distributed. [00:35:36] Speaker 04: Assume it was marketed for the purpose you don't like. [00:35:40] Speaker 05: Yeah. [00:35:41] Speaker 05: And that's where I'm coming into on whether or not it would come into a particular prohibition under 331. [00:35:49] Speaker 06: Assume it is a banned device. [00:35:51] Speaker 06: Can they keep on using it if they had it in the past? [00:35:54] Speaker 05: I think that's going to pretend I'm a particular enforcement action or a seizure action, but generally speaking. [00:36:00] Speaker 03: Right. [00:36:00] Speaker 03: Maybe it's subject to seizure. [00:36:02] Speaker 03: I get that. [00:36:03] Speaker 03: I think your argument would be with any banned device, even if it hasn't been banned before, there's an authority under 334, I think it is, to seize it. [00:36:13] Speaker 03: I get that. [00:36:14] Speaker 03: And that may be controversial, but let's just put that to one side. [00:36:17] Speaker 03: Suppose there's no seizure. [00:36:19] Speaker 03: The government doesn't want to seize it. [00:36:21] Speaker 03: The question is, can the doctor, the healthcare practitioner continue using the device with respect to patients onsite in the same way that they had before? [00:36:32] Speaker 03: 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. [00:36:39] Speaker 03: If they can continue using it that way, well then it puts a whole new lens on the interrelationship between banning and 396. [00:36:46] Speaker 03: Cause it seems like you've got an answer that says, well under 396, it actually doesn't inhibit [00:36:51] Speaker 03: It doesn't restrict the practice of medicine in the same way that's been conceived of because the healthcare practitioner can actually continue using the device in the same way. [00:37:01] Speaker 03: The band doesn't inhibit that to the same extent that's been posited here. [00:37:05] Speaker 03: That's why I think we're trying to [00:37:07] Speaker 03: Suss out an answer to that. [00:37:09] Speaker 03: What exact effect does 396 have vis-a-vis a device that's now banned on somebody who already possessed the device has already been using it for a particular purpose. [00:37:21] Speaker 03: Can that continue to happen? [00:37:23] Speaker 05: And I think generally speaking, so long as the device has another lawfully- Well, that's the part where you're killing your answer. [00:37:31] Speaker 06: We don't want to know so long as the device says no. [00:37:34] Speaker 06: We want to know right now the facts on the world [00:37:37] Speaker 06: real facts are that these doctors have been using this or these medical practitioners been using this not for other purposes it has no other purpose there but this now this is the real world this is not a hypothetical can they continue doing what they've been doing consistent with your band [00:37:56] Speaker 06: that's why your honor i'm still trying to give you the correct answer and not make a mistake you're not going to get an answer by me that has any of that so long as or hasn't it that if we know what the facts are this is not a hypothetical your honor answering on these facts 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 so your answer is yes they can keep using it [00:38:22] Speaker 05: Your honor, I'm trying to give the correct answer. [00:38:24] Speaker 05: I think I generally agree with what Chief Judge Srinivasan said, which is that generally speaking, the off-label prescription of a medical device is permitted, and that's what 396 recognizes. [00:38:37] Speaker 03: So in this case, because you started saying as long as it's got some other use. [00:38:41] Speaker 03: Now in this case with this device, it does have another use because it can be used for smoking. [00:38:45] Speaker 03: So we've already crossed that. [00:38:47] Speaker 03: So it sounds to me like the government's position is, [00:38:51] Speaker 03: that not withstanding the ban, that for healthcare practitioners who are on site, they can actually continue using this device in the way that they were using it before. [00:39:03] Speaker 03: And I think now there may be a seizure at the end of the day, that may be an enforcement, there may be some seizure because of the ban, but unless it's been seized in terms of the devices that are already on site, those can continue to be used in the same way. [00:39:18] Speaker 05: I think that that's generally true. [00:39:20] Speaker 05: And the only hesitation that I was positing is because we haven't briefed this. [00:39:23] Speaker 05: And that's why I have a hesitation on it because I haven't nailed it down exactly is isolating exactly what the lawfully marketed portion of it means here. [00:39:31] Speaker 05: Because again, what we've done here in the banning rule is not try to regulate how a particular healthcare practitioner uses a device off label, but rather state whether [00:39:44] Speaker 05: These devices used for this purpose present a substantial and unreasonable risk of injury that can't be corrected by labeling you then say that things would be said to seizure if the center continues to use them for this purpose. [00:39:57] Speaker 05: I think if the center is distributing them to their doctors for the purpose that for this intended use that is banned and considered adulterated, then generally speaking, that's that can lead to a seizure action for. [00:40:11] Speaker 06: We really do have an issue as to whether or not you're interfering in the practice of medicine in violating the statute. [00:40:17] Speaker 05: No, Your Honor, because generally speaking, devices and drugs can be considered adulterated and their manufacturing distributed can be limited and seized. [00:40:27] Speaker 05: 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. [00:40:37] Speaker 04: Your theory, as I understand it, is that the FDA has discretion [00:40:47] Speaker 04: to treat different uses as different devices for purposes running throughout the statute, including the ban provision, correct? [00:41:02] Speaker 04: That's correct, your honor. [00:41:03] Speaker 04: Okay, but for decades, the idea of practice of medicine, the thing that was protected [00:41:17] Speaker 04: with regard to drugs and with regard to devices was the ability of a physician to take the article, the 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. [00:41:44] Speaker 04: Now, on your theory, if the FDA has the ability to slice up those uses and say one of them is really a different device and therefore it can be banned, there is no practice of medicine that's beyond your authority. [00:42:05] Speaker 05: No, I don't think so, Your Honor. [00:42:07] Speaker 05: I think under the concern that you've laid out there is that the [00:42:14] Speaker 05: what the effect of the ban is and the effect of declaring it adulterated for particular use is whether or not that device as marketed for that particular use and distributed for that particular use is widely available in the marketplace. [00:42:26] Speaker 05: So long as the same physical technology, right? [00:42:29] Speaker 05: Either for the powder and the powder gloves example or the election. [00:42:33] Speaker 04: Let's just assume for the sake of argument that the ability to seize is enough, right? [00:42:40] Speaker 04: Put aside the debate over [00:42:42] Speaker 04: the downstream consequences. [00:42:45] Speaker 04: Let's assume the consequence of banning is that banning for a use is that the physician can't prescribe for that use. [00:42:54] Speaker 05: I don't think that would be the consequence of the seizure action. [00:42:58] Speaker 05: As I understood it is that generally speaking, you're looking to the intended use of the manufacturer or the distributor. [00:43:04] Speaker 04: And so long as- So the effect of the ban in making this product adulterated when and only when it's intended use is for treating these severe [00:43:23] Speaker 04: issues as opposed to nail biting. [00:43:27] Speaker 04: The effect of that is the physician can continue using the device, but if he does, then you can come in and seize it. [00:43:42] Speaker 05: No, and again, that's why I was looking to the manufacturer and distributor's intent. [00:43:47] Speaker 04: I mean, now you're completely losing me. [00:43:50] Speaker 04: I mean, these devices, [00:43:53] Speaker 04: These devices have two intended uses, right? [00:43:56] Speaker 04: One is treating these disorders and another is treating smoking and nail biting. [00:44:04] Speaker 04: And your theory is that you can ban the one use, but not the other use. [00:44:11] Speaker 04: You can use your section 360F power to ban one use, but not the other use. [00:44:19] Speaker 04: Yes, and that's exactly what happened. [00:44:21] Speaker 04: And the consequence of that is that the device becomes adulterated when used for one purpose, but not the other. [00:44:32] Speaker 05: And that's exactly what we did in the powdered gloves rule, right? [00:44:35] Speaker 05: Was that powder for a surgical gloves can present an acute risk of infection, allergic reaction. [00:44:42] Speaker 04: I don't ever go to court. [00:44:43] Speaker 04: I don't understand how your answer, let's just focus on the ban. [00:44:49] Speaker 04: Can the, I'm sorry, the seizure, can the FDA come in and seize devices that this center continues to use [00:44:59] Speaker 04: or the now prohibited purpose of treating these disorders. [00:45:04] Speaker 04: I don't know how your answer can be anything other than yes, they can seize the device. [00:45:09] Speaker 05: And that's why I was trying to distinguish between a distributor and the physician, right? [00:45:13] Speaker 05: If the center is acting as a distributor, giving out these devices for the intended use of treating self-injurious and aggressive behavior, then yes, I think that that falls within the adulteration and prohibited acts. [00:45:25] Speaker 04: The problem is there's nothing in 334, the seizure authority that [00:45:32] Speaker 04: draws that distinction. [00:45:34] Speaker 04: It says if the device is adulterated, it can be seized. [00:45:39] Speaker 05: So that's why I'm working back because all these provisions interact with each other, right? [00:45:44] Speaker 05: So 351 defines what's adulterated. [00:45:47] Speaker 05: And 351G says it's adulterated if it's a banned device. [00:45:50] Speaker 05: Banned device, it's adulterated. [00:45:52] Speaker 05: Right. [00:45:53] Speaker 05: And so what 396 and the general practice of medicine exception recognizes that physicians are permitted to prescribe devices even for off-label uses. [00:46:02] Speaker 05: And so you generally don't look to the intent of the position about how the device is going to be used because that falls within practice of medicine. [00:46:09] Speaker 06: So in this case, if, if medical professionals at the center continue to use this against the self destructive behavior. [00:46:19] Speaker 06: Are they going to be subject to seizure because it's becoming an adulterated device by being so used? [00:46:26] Speaker 05: Based on the practitioner's actions, no. [00:46:29] Speaker 05: But if the center is acting as a distributor and distributing these devices for a particular purpose that FDA has found causes substantial and 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. [00:46:48] Speaker 06: Would you be satisfied, would your client be satisfied with an opinion of this court that says we're not striking down your ban, but you are not lawfully entitled to go in and seize their devices? [00:47:03] Speaker 05: Well, I don't think that that would be before the court, but I also think that it would depend on the particular predicate for a seizure action, right? [00:47:12] Speaker 04: If they got devices- Let's assume that [00:47:17] Speaker 04: they are not either selling the device or even transferring the device for free to any entity outside the Rothenberg clinic. [00:47:37] Speaker 04: Okay, but within the Rothenberg clinic, the devices are on the shelf [00:47:45] Speaker 04: physicians use them. [00:47:48] Speaker 04: One physician is treating a patient and can't come in that day and says to a colleague, please do the treatment. [00:48:02] Speaker 04: Would that be distribution? [00:48:04] Speaker 05: Your honor, I don't know because this gets into exactly how 331 K applies and held for sale. [00:48:09] Speaker 05: And I know that's a nuanced area. [00:48:10] Speaker 05: We're not in an enforcement action right now. [00:48:13] Speaker 05: 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 and in particular enforcement action, this quarter or another can encounter that and deal with it. [00:48:25] Speaker 06: And we can brief it fully, but the only thing that's doing the possibility of an enforcement action. [00:48:31] Speaker 05: Because it depends on the particular consequences, as we talked about, about whether the center's acting as a distributor or whether somebody else is. [00:48:39] Speaker 05: And there are cases in which somebody does act as a distributor and encounters a prohibited act. [00:48:44] Speaker 05: Like I gave the example of a doctor acting as a distributor for an insanitary medical device. [00:48:51] Speaker 05: And liability can rise there. [00:48:52] Speaker 05: But we're not in an enforcement context here. [00:48:54] Speaker 05: The only question that's on the table, as I understand it in this practice of medicine argument, is can FDA [00:49:01] Speaker 05: promulgate a general rule that's applicable 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 FDA and the expert panel considered. [00:49:21] Speaker 05: And I think that is within FDA's general ability to... That really is the question. [00:49:27] Speaker 03: But it's not just a question of the abstract, because in order to know whether the FDA has the authority to ban it, the FDA has to take account of 396. [00:49:39] Speaker 03: And so the scope of 396's insulation of health care practitioners, notwithstanding the ban, necessarily informs, it seems to me, [00:49:50] Speaker 03: is permissible because 396 is a statute that's on the books that has to be contended with. [00:49:58] Speaker 03: I think, and I appreciate that you can't know every hypothetical and know for sure how it would be handled in an enforcement action. [00:50:03] Speaker 03: 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 not withstanding that this device has been banned for this use, there are at least some situations in which healthcare practitioners at the facility, at the center can continue using [00:50:25] Speaker 03: device for the use that has been used for to date without running afoul of the law. [00:50:32] Speaker 05: 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 exception. [00:50:43] Speaker 03: Now that may be an exception that's exceptionally narrow if it turns out that [00:50:48] Speaker 03: you know, even moving your own device from one shelf to another is a self-distribution or something. [00:50:52] Speaker 03: I mean, at some point, the distribution idea swallows the insulation of the practice of medicine provision. [00:51:02] Speaker 03: And there may be some permutations there, but I have a- Can I just follow up on that? [00:51:08] Speaker 04: I mean, that's a very odd view. [00:51:13] Speaker 04: I mean, on the front end, [00:51:17] Speaker 04: your approval of a device is specific or an intended use, right? [00:51:27] Speaker 04: Yes. [00:51:28] Speaker 04: And the manufacturer, and it is always the case that the man, if you focus on the manufacturer of the device versus the physicians at Rothenberg, it's always the case that even without any ban, [00:51:45] Speaker 04: The manufacturers, all that the manufacturers can do is manufacture the device intending that it be used for the approved use and market it for the approved use, right? [00:52:04] Speaker 04: That they can't do anything vis-a-vis the unapproved use. [00:52:09] Speaker 04: So if your theory of the ban is, well, you're just restricting [00:52:14] Speaker 04: manufacturers but not the doctors in any meaningful way, the band really isn't doing anything. [00:52:22] Speaker 05: Well, I think the ban is doing something, right? [00:52:24] Speaker 05: To the extent that a manufacturer distributor is acting in a way that, yeah, we are going to only do these for self-injurious and aggressive behaviors. [00:52:32] Speaker 05: We think this is great for that. [00:52:34] Speaker 05: We're going to market this and advocate for its use in that way. [00:52:37] Speaker 05: That's something that the FDCA generally covers. [00:52:41] Speaker 05: Or alternatively, if somebody, I guess it would depend on the facts of a particular enforcement action, but if somebody is distributing these [00:52:48] Speaker 05: with a wink and a nod understanding back for dealings of like, oh, we're facially saying that it's for this proof, but everybody knows it's for the band adulterated purpose. [00:52:57] Speaker 05: I think that's where it also has teeth in that scenario. [00:53:01] Speaker 05: And I mean, again, that's all on the enforcement end of the spectrum. [00:53:05] Speaker 05: And if the court or anybody else has concerns about general practice of medicine, I think that that's where they're best felt. [00:53:10] Speaker 06: But FTC, it would be best felt at the beginning when you talk about whether you got the man at all or not. [00:53:17] Speaker 06: When you're talking about regulating the use, that's regulating the practice of medicine. [00:53:24] Speaker 06: that's something left of the states and you should have been people that object to this thing should have been lobby in Massachusetts instead of the FDA. [00:53:33] Speaker 05: Your honor FDA regularly classifies devices differently based on their intended use because when you look to the intended use to recognize that they have different risks and effectiveness and so for we give the example of the gloves what have you banned [00:53:48] Speaker 06: So there have only been three banning sale, but you can't get them at labeling. [00:53:53] Speaker 06: If you think about some labeling and not, not, not banning generally, aren't you? [00:53:57] Speaker 05: Or pre-market approval. [00:53:58] Speaker 05: So class three devices, for instance, necessarily present unreasonable risks of injury, but also have other benefits to them. [00:54:05] Speaker 05: And that's where you need pre-market approval in particular labeling for them. [00:54:08] Speaker 06: So in that, in that example, is there anything where you've banned a device solely because of its use? [00:54:15] Speaker 05: So that would be the powder and the powdered gloves example. [00:54:18] Speaker 06: That's the best example you've got. [00:54:19] Speaker 06: And it's never been to court, has it? [00:54:21] Speaker 05: Well, Your Honor, FDA has only banned essentially three devices in its history because it's been pretty judicious with this authority. [00:54:28] Speaker 05: It banned prosthetic hair fibers for insertion into the scalp. [00:54:32] Speaker 05: It banned the powdered gloves and the powder that goes on. [00:54:35] Speaker 03: In the pre-market approval context, which is more standard fare than the ban, I know that the ban has been not used very often. [00:54:42] Speaker 03: The pre-market approval process obviously is used all the time. [00:54:45] Speaker 03: On that one, healthcare practitioners still have an insulated zone under 396, not withstanding a pre-market approval. [00:54:57] Speaker 03: That's where the off-label use comes into play in full force. [00:55:01] Speaker 03: So there's some insulating work that 396 is doing. [00:55:04] Speaker 03: And the question for us is, and for you, is what insulating work is 396 doing in the band context? [00:55:10] Speaker 03: Now, I have a broader question for you on this, which is, [00:55:14] Speaker 03: We've been talking now for a long time about how to appropriately construe 396 and how to interrelate 396 with 360F. [00:55:24] Speaker 03: I don't know if I have the numbers 360F. [00:55:28] Speaker 03: Why does your brief not cite Chevron? [00:55:32] Speaker 03: This just seems like what we're doing here is we're just construing these statutes and trying to figure out how they interrelate. [00:55:38] Speaker 03: And I'm just wondering, does the agency not think that it's [00:55:44] Speaker 03: interpretation of these provisions and the way they interrelate is something as to which it has interpretive authority. [00:55:53] Speaker 05: I think the FDA definitely has interpretive authority over the FTCA. [00:55:59] Speaker 05: To be honest, I didn't understand this to be a Chevron issue. [00:56:02] Speaker 05: We've just thought that these always relate to each other in a fairly straightforward fashion, and there might be a concern. [00:56:07] Speaker 03: But then, can I just stop you right there? [00:56:08] Speaker 03: When you say you don't think it's a Chevron issue, I get confused when I hear you then follow up by saying they interrelate in a straightforward fashion. [00:56:16] Speaker 03: That still seems to me that you're doing statutory interpretation. [00:56:19] Speaker 03: You may think the answer is easy, [00:56:21] Speaker 03: But it still seems to me you're doing statutory interpretation. [00:56:24] Speaker 03: And if you're doing statutory interpretation with respect to a provision as to which you have interpretive authority, then isn't that Chevron land? [00:56:32] Speaker 03: I guess the question would be whether we're at Chevron step two yet. [00:56:36] Speaker 03: No, no, I'm not. [00:56:38] Speaker 03: I'm not talking about that. [00:56:39] Speaker 03: I'm just talking about, are we doing Chevron at all here? [00:56:43] Speaker 03: Are you doing Chevron at all here? [00:56:45] Speaker 03: And if you are, it sounds to me like your answer is yes. [00:56:47] Speaker 03: You just think that it's easy that you win. [00:56:50] Speaker 03: So you don't need Chevron. [00:56:51] Speaker 03: I guess my question is, and maybe I've got that wrong. [00:56:54] Speaker 03: If I've got that wrong, tell me. [00:56:56] Speaker 03: But it sounds to me like that's what you're saying. [00:56:57] Speaker 03: And what I don't understand is if that's where you are, then why wouldn't you just invoke it anyway? [00:57:02] Speaker 03: As I, as I think the department has done for decades when it's have Chevron authority is always argued. [00:57:10] Speaker 03: Well, I think we win anyway, but Chevron makes it easy because all our interpretation has to be as reasonable. [00:57:16] Speaker 03: 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. [00:57:26] Speaker 05: We thought that the case was fairly straightforward enough that we didn't need Chevron. [00:57:29] Speaker 05: I'm not resisting the application of Chevron here. [00:57:32] Speaker 03: But why, 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? [00:57:41] Speaker 05: doesn't it just make it easier your honor we think for all the reasons in our brief that this the court can affirm you know obviously we're not acting in a way to try to constrain the court's consideration of these issues but you do think that the court might disagree with you on that i'm sorry your honor did you consider the possibility the judge might disagree with you on the proposition you just stated [00:58:02] Speaker 05: I am considering it now, and that's why I'm saying that this is an issue. [00:58:05] Speaker 06: It was a little late in the day, Council. [00:58:07] Speaker 05: Yes, Your Honor. [00:58:08] Speaker 05: Like I said, we thought that we went on this issue just in a pretty straightforward fashion. [00:58:13] Speaker 04: One more question for me, which is the proposal to ban said the ban would apply to devices to [00:58:31] Speaker 04: ESDs, and now I'm quoting, already in commercial distribution and devices already sold to the ultimate user, as well as devices sold or commercially distributed in the future. [00:58:50] Speaker 04: Given that, isn't it a little bit rich for you to say that if [00:59:00] Speaker 04: there any 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 applied to the downstream doctors. [00:59:18] Speaker 05: No, your honor, as we explained, right, you're still in those instances looking to what the intended use was on the distributor and the manufacturer. [00:59:26] Speaker 05: That's the problem the device, right. [00:59:28] Speaker 06: And the problem. [00:59:29] Speaker 05: I have a problem. [00:59:31] Speaker 05: I don't think it is a problem, your honor, if you look to and we cited this house report in the brief of HR rep number 94 dash 853. [00:59:39] Speaker 05: It's the Congress report from when they passed the Medical Device Act and their [00:59:43] Speaker 05: Congress is clearly saying we expect that the secretary when a particular item has different uses that the secretary can say that that's a different device, depending on its different use. [00:59:53] Speaker 05: And so I don't think it's at all odd for FDA to when it enacts a banning rule to say that this applies to the devices that are already in use. [01:00:01] Speaker 04: It brings us back to your what I think is your primary defense, which is that [01:00:09] Speaker 04: the banning authority allows you to pick off individual uses, but it tends to foreclose an alternative defense that this is really no big deal because the consequence of the ban really doesn't impair retail practitioners. [01:00:31] Speaker 05: If a practitioner wants 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 context. [01:00:53] Speaker 05: And that's why FDA's general banning rule doesn't run afoul of these concerns. [01:00:57] Speaker 06: And if this device is banned under the ban we have here and the doctor does that, does he not run the risk of the enforcement proceeding taking the device? [01:01:09] Speaker 05: So if, if, if the devices intended use has been lawful, right? [01:01:14] Speaker 05: Like if it's a, and I'm just trying to take it as a lawful use for smoking. [01:01:17] Speaker 06: We have, we don't have an if here. [01:01:19] Speaker 06: We have a real case. [01:01:20] Speaker 06: If he has a device, he's using it for the self destructive behavior. [01:01:29] Speaker 06: Would he not be subject after doing so to having the enforcement proceeding brought? [01:01:34] Speaker 05: I don't know what the enforcement proceeding in that hypothetical would be against the doctor. [01:01:38] Speaker 05: I'm not sure. [01:01:39] Speaker 03: Right. [01:01:39] Speaker 03: So it would be against the device. [01:01:41] Speaker 03: I think that is an important distinction because as I take it, your position is even if the device is subject to seizure, [01:01:47] Speaker 03: which it may be, that's not an enforcement action against the doctor for anything the doctor. [01:01:52] Speaker 06: All right. [01:01:53] Speaker 06: That's fine. [01:01:54] Speaker 06: I'll take that qualification. [01:01:56] Speaker 06: Would it not be that the device would be subject to an enforcement procedure? [01:02:02] Speaker 05: Yeah. [01:02:02] Speaker 05: And that was the, the, the particular distinction that I was making. [01:02:06] Speaker 05: Cause as this court and others have recognized, right? [01:02:08] Speaker 06: The general without a difference though, counsel, my question still is, would it not be a possibility of an enforcement proceeding if the doctor continues to use this device for the treatment of self-destructive behavior? [01:02:19] Speaker 06: If the only intended use of this device in there, this, this is not a hypothetical. [01:02:25] Speaker 06: This is a real case. [01:02:26] Speaker 06: Your honor is using it. [01:02:28] Speaker 06: I'm trying to be doctor continues to use it. [01:02:31] Speaker 06: Will the doctor stand in the danger of having the seizure procedure? [01:02:36] Speaker 05: And that's why I think the answer depends on a particular fact. [01:02:42] Speaker 05: And that's what I'm trying to delineate here. [01:02:44] Speaker 06: That's why I use the term possibility instead of saying it would definitely happen. [01:02:47] Speaker 05: Right. [01:02:48] Speaker 05: So if the only intended use of this device for the treating self-injury. [01:02:53] Speaker 06: That's all the doctors using it for is for self-destructive behavior. [01:02:56] Speaker 06: You've got that fact on the table. [01:02:58] Speaker 06: Quit trying to make up a different case. [01:03:00] Speaker 05: 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. [01:03:07] Speaker 05: If the intent otherwise is coming from a distributor and a manufacturer, then I think it is subject to the general prohibitions. [01:03:15] Speaker 03: And before we completely end, can 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 [01:03:29] Speaker 03: affect a waiver of Chevron. [01:03:32] Speaker 03: But that presupposes from our purposes that Chevron would otherwise apply had the government invoked it. [01:03:36] Speaker 03: I just want to make sure you don't have any reason as the government to tell us that Chevron doesn't apply here. [01:03:44] Speaker 03: I am not here today to tell you that Chevron doesn't apply. [01:03:46] Speaker 03: Okay. [01:03:48] Speaker 03: Let me make sure my colleagues don't have any additional questions for you. [01:03:52] Speaker 03: Thanks. [01:03:53] Speaker 03: Okay. [01:03:53] Speaker 03: Thank you, Mr. Aguilar. [01:03:55] Speaker 03: Each of the petitioners council I believe has one minute [01:03:58] Speaker 03: For Roboto, we'll give you your one minute. [01:04:00] Speaker 02: Thank you, Your Honor. [01:04:01] Speaker 02: Your Honor, first of all, to make it clear what the ban does is, as the passage that Judge Katz has read from, it clearly bans the use of these devices. [01:04:15] Speaker 02: And it specifies that for the compliance date is 30 days, except for those which are currently being used and for those [01:04:26] Speaker 02: FDA gives JRC and my clients six months, and then it has to end. [01:04:35] Speaker 02: Specifically, that's what the rule says. [01:04:37] Speaker 06: That's the whole gist of the transition section of the opinion as well, isn't it? [01:04:41] Speaker 02: Correct. [01:04:43] Speaker 02: And for that reason, we had to go to FDA and seek a stay. [01:04:47] Speaker 02: That's the only reason we had a secret stay on this point. [01:04:53] Speaker 02: As far as what enforcement they could use, they could use seizure, but it's also a crime to use an adulterated device. [01:05:03] Speaker 02: And what doctor is going to take that risk that the FDA may give him the pass on using what the FDA- What's the statute that makes it a crime? [01:05:14] Speaker 02: I don't have it. [01:05:15] Speaker 02: I don't have the- That's all right. [01:05:18] Speaker 04: Is it 331, which says, 331 is the general provision in the FDCA, which describes as a prohibited act. [01:05:30] Speaker 04: the introduction or delivery for introduction into interstate commerce of an adulterated food, drug, or device. [01:05:40] Speaker 02: There is a separate statute, I do not have the number in mind, which says violation of 331, those prohibited acts of crime. [01:05:50] Speaker 02: And there are cases which deal with the practice of medicine issue, which arise in the criminal context. [01:05:57] Speaker 02: I think regenerative sciences might've been one of those cases where there was a criminal prosecution. [01:06:04] Speaker 04: I mean, I take your point about risk, but it does seem to me you would have a pretty good argument that the center, no matter how it shares and uses and moves around the devices at the center, is not introducing them into interstate commerce. [01:06:26] Speaker 02: That's true, but the FDA doesn't see itself limited to interstate commerce. [01:06:32] Speaker 02: And the obvious intent and purpose of this statute is to end explicitly the use of these devices for this purpose. [01:06:44] Speaker 06: You don't mean the purpose of the statute, you mean the purpose of the FDA. [01:06:49] Speaker 02: Yes, correct. [01:06:50] Speaker 02: Exactly. [01:06:52] Speaker 03: Now, make sure my colleagues don't have any additional questions. [01:06:57] Speaker 02: One further observation to make if I can make it really quickly. [01:07:04] Speaker 02: I think that what the FDH theory does is it would create this gaping exception to section 396. [01:07:13] Speaker 02: And what this court said just last week in the genus case would apply here, which is that, and the court quoted the Supreme Court, you don't generally make fundamental changes with subtle moves. [01:07:26] Speaker 02: And that's really what they're saying here. [01:07:30] Speaker 06: That's what we say to the NBA, and nobody cited it back. [01:07:33] Speaker 02: There's no application of Chevron here, and it's telling that they never raised it. [01:07:42] Speaker 02: Congress spoke directly to this issue. [01:07:45] Speaker 02: It doesn't even rise. [01:07:46] Speaker 02: And if you did get there, this would be a completely unreasonable interpretation. [01:07:52] Speaker 03: OK, thank you, Mr. Stern. [01:07:54] Speaker 03: Mr. Flamio, we'll give you one minute of rebuttal. [01:07:56] Speaker 01: Yes, thank you, Your Honor. [01:07:58] Speaker 01: With respect to the criminal statute, use of a adulterated device would subject the health care practitioner to up to a year in prison for a first offense. [01:08:07] Speaker 01: That's at 21 USC section 333A1. [01:08:13] Speaker 01: Your Honor, this is the practice of medicine. [01:08:17] Speaker 04: And that is specifically use as opposed to introduction into interstate commerce? [01:08:24] Speaker 01: I believe it's use, Your Honor. [01:08:26] Speaker 04: OK. [01:08:26] Speaker 01: believe it's used. [01:08:31] Speaker 01: It is the practice of medicine to ban one specific use of device, but allow it for smoking or nail butting. [01:08:37] Speaker 01: And it's the same, the device would cause the same level of pain. [01:08:41] Speaker 01: So the statute isn't accomplishing any, the ban, I should say, isn't accomplishing anything, but the FDA would use it. [01:08:49] Speaker 01: Because of all these uncertainties against JRC and the healthcare practitioners there, [01:08:55] Speaker 01: to frighten them into not using it because of these potential criminal liabilities and everything else. [01:09:02] Speaker 01: So the ban doesn't meet the requirements of the statute. [01:09:06] Speaker 01: It should not be allowed to stand. [01:09:08] Speaker 01: And it shouldn't also be allowed to harm these petitioners who need this treatment to survive and allow the FDA to harass them and threaten them. [01:09:19] Speaker 01: to stop using the treatment. [01:09:20] Speaker 01: So your honor. [01:09:21] Speaker 03: Can I just ask you one question right as we close, which is, and you may not know the answer to 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 prohibited? [01:09:39] Speaker 03: Do you know of anything? [01:09:40] Speaker 01: No, not to my knowledge. [01:09:42] Speaker 01: And it's clear in the record, the FDA's treatment of these petitioners [01:09:47] Speaker 01: has been harassment, unfairness. [01:09:50] Speaker 01: All they want to do is stop JRC from using this treatment on these clients who need it to survive. [01:09:56] Speaker 01: And this ban needs to be set aside to protect them. [01:09:59] Speaker 03: Okay. [01:10:00] Speaker 03: Thank you, counsel. [01:10:01] Speaker 03: Thank you to all counsel this morning. [01:10:03] Speaker 03: We'll take this case under submission.