[00:00:01] Speaker 03: Case number 16-1007, Eric Friedman, Petitioner versus Federal Aviation Administration. [00:00:08] Speaker 03: Mr. Chen for the petitioner, Ms. [00:00:10] Speaker 03: Sheridan for the respondent. [00:00:12] Speaker 03: Good morning. [00:00:13] Speaker 00: Good morning, Your Honors, and may it please the Court. [00:00:15] Speaker 00: This case arises out of an undisputed impasse between the FAA and Friedman. [00:00:20] Speaker 00: The FAA's unchanging position is that for insulin-treated diabetic pilots, continuous glucose monitoring data is a prerequisite for first-class medical certification. [00:00:31] Speaker 00: Friedman has repeatedly declined such requests, which require him to insert a sensor under his skin for 90 days, pay thousands of dollars out of pocket, and disregard the considered advice of his longtime treating physicians. [00:00:44] Speaker 03: Well, it's certainly an impasse, but is it final agency action? [00:00:49] Speaker 00: Yes, Your Honor. [00:00:50] Speaker 00: In this case, the impasse is final, and that's because the impasse marks the consummation of the FAA's decision-making process. [00:00:59] Speaker 00: And we see that in several places. [00:01:00] Speaker 00: In particular, at JA-51, Friedman makes crystal clear for the third time to the FAA that he, quote, does not use a CGM, and therefore the FAA should make a decision based on the present record. [00:01:12] Speaker 00: At JA 53, the FAA responds one week later and states that it is, quote, unable to proceed. [00:01:19] Speaker 00: And now in its brief before this court at page 26, the FAA concedes that to the extent Friedman will not provide CGM, i.e. [00:01:28] Speaker 00: the situation here, [00:01:29] Speaker 00: the parties have reached an impasse. [00:01:31] Speaker 00: And the reason that the impasse is necessarily final here, Your Honors, is that agreement about the unchanging status quo must evidence a denial. [00:01:40] Speaker 00: That is what the FAA has said repeatedly in its brief at pages 11 to 14. [00:01:44] Speaker 00: It stresses that CGM is required and necessary. [00:01:47] Speaker 00: And indeed, that is the exact result that the FAA forecasted to Mr. Friedman and continues to forecast here. [00:01:54] Speaker 00: at J. A. [00:01:55] Speaker 00: 55 in its third letter to Mr. Friedman requesting CGM, it states, if you are unable to provide this information, we will have no alternative except to deny. [00:02:08] Speaker 00: And that's something that it continues to say, and it's brief. [00:02:11] Speaker 00: And here we think that the FAA should not be able to avoid judicial review by indefinitely withholding a formal acknowledgement. [00:02:18] Speaker 00: To be sure, the FAA states that, in its letter at J-47, that the first-class application remains under consideration, but we think that label is belied by the record. [00:02:30] Speaker 00: And in any event, this court does not ultimately look to the label that the agency affixes to the action. [00:02:36] Speaker 00: Instead, it takes a pragmatic approach to finality, where effectively final action not acknowledged is nonetheless final. [00:02:44] Speaker 02: But the agency, maybe your best response is what you've just said, but the agency says in its December 1st letter, we look forward to reviewing that information. [00:02:55] Speaker 02: when you are able to provide it. [00:02:57] Speaker 02: So they've said, this is an ongoing process. [00:03:00] Speaker 02: We're seeking more information so we can start our review, and you haven't provided it. [00:03:06] Speaker 00: Well, your honor, that's correct. [00:03:08] Speaker 00: It does say that. [00:03:08] Speaker 00: And I would point out that in its brief, the FAA essentially takes two scenarios. [00:03:13] Speaker 00: The first scenario is that Mr. Friedman might actually submit this CGM data. [00:03:18] Speaker 00: But as I stated at J-51 and 53, that's not going to happen. [00:03:22] Speaker 00: We've had a back and forth exchange over more than six months. [00:03:25] Speaker 02: Where is that in the record that your client has stated, I will not [00:03:31] Speaker 02: It's not a question of we're in a back and forth negotiation and maybe when I realize that your position in FAA is really firm, then I will cough up the money and go through the hardship of providing it. [00:03:49] Speaker 02: Is there anywhere where he said, no, my final position is I will not provide it? [00:03:53] Speaker 00: Well, no, there is not, Your Honor. [00:03:54] Speaker 00: But what I would say is that this sort of exchange between the parties is very clear. [00:03:59] Speaker 00: It's clear that he does not use a CGM. [00:04:01] Speaker 00: It's also very clear that it's not medically indicated. [00:04:04] Speaker 00: And he has repeatedly asked the FAA to explain why he should undergo CGM therapy without, and absent that explanation, which is clearly not coming at this point, we would say that, essentially, that's the result that we have here. [00:04:21] Speaker 02: But that kind of exchange, I think, undermines your point to the extent that the question is, are the parties in a process of negotiating that the FAA could reasonably have thought was ongoing, or have they each crystallized in their position, in which case it might be final? [00:04:41] Speaker 02: And you said, well, it's not medically indicated, but the FAA may be thinking, we're in the process of making a big change in policy. [00:04:49] Speaker 02: We have the safety of a lot of people on our shoulders. [00:04:52] Speaker 02: And we'd like more than what is medically indicated for the individual's care. [00:04:55] Speaker 02: We'd like some information that goes beyond that. [00:04:59] Speaker 02: And so to the extent that your client has not said, [00:05:02] Speaker 02: Sorry, you know, process it based on what I've given you or don't process it at all, but that's it. [00:05:08] Speaker 02: He hasn't said that. [00:05:09] Speaker 02: That I think undercuts a little bit your position on finance. [00:05:13] Speaker 00: Well, your honor, just because it's not explicit doesn't mean that's not the case here. [00:05:16] Speaker 00: And here I would look to the FAA's actual statements. [00:05:19] Speaker 00: They actually say, we are unable to proceed. [00:05:21] Speaker 00: They are not considering anything else that we know of at this point. [00:05:25] Speaker 00: They have the data that they have. [00:05:26] Speaker 02: He's made his, I mean, the FAA has made its position clear, but has your client made his position clear? [00:05:32] Speaker 02: Are they waiting for him to come around? [00:05:34] Speaker 00: uh... well your honor i i think he has made that position clear although he doesn't say that he flatly will not do it they have not provided the explanation on three occasions and we think that three occasions is more than enough this is going on for several months and nobody is breaking the impasse there is an acknowledged impasse here that the fba agrees with [00:05:54] Speaker 02: formally, until they've taken final action, they don't actually have a duty to explain their action. [00:06:03] Speaker 02: It's finality that triggers that duty now. [00:06:05] Speaker 00: Well, again, Your Honor, I would look to the FAA statements where it says, if you do not provide this data, the consequence is that we will have no alternative except to deny your applications. [00:06:16] Speaker 00: And it follows that up immediately by saying, we're not considering anything further at this point. [00:06:23] Speaker 00: And so at that point, the agency has consummated its decision-making process. [00:06:28] Speaker 00: There is no more thought that the agency is giving to this question at this time. [00:06:32] Speaker 00: And we don't think that given... Let me ask it another way. [00:06:36] Speaker 02: What is the relief that your client is seeking? [00:06:43] Speaker 00: We are seeking a remand for the FAA to consider and dispose of the application on the merits within 30 days without regard to CGM data. [00:06:56] Speaker 00: And we think that is well supported by the record here. [00:06:59] Speaker 00: The record uniformly and explicitly undercuts the FAA's claims about the medical relevance of CGM data, which is the standard here, we think. [00:07:07] Speaker 00: The FAA's sole support for its request for CGM data is the ADA's letter at JA65, but it takes that letter entirely out of context, we would say. [00:07:16] Speaker 00: The relevant statements in that letter are that CGM is neither necessary nor appropriate for making medical certification decisions. [00:07:23] Speaker 00: and is less accurate, and that its use would be less accurate than glucometer data and would invite confusion and misinterpretation. [00:07:33] Speaker 02: Where in the administrative record did your client request that relief of the agency, consideration of his application on its merits without regard to CGM data? [00:07:47] Speaker 00: I believe he says it in his response at JA-51. [00:07:50] Speaker 00: That's the letter. [00:07:51] Speaker 00: It might be on pages 52 or 53. [00:07:53] Speaker 00: But I believe he says, if you are not able to provide me with an explanation, I hope that you would proceed on my application based on the present record. [00:08:06] Speaker 00: That's what I believe it says on JA-51. [00:08:13] Speaker 00: And also on page 52 at the very end. [00:08:16] Speaker 03: You said, I think in response to Judge Pillard's question, that what you wanted is a remand to the agency for them to dispose of the application. [00:08:29] Speaker 03: Do you want them to dispose of the application or do you want an explanation? [00:08:35] Speaker 00: Well, either would do, we think, Your Honor, but we do think that they should either grant or deny it. [00:08:40] Speaker 00: And obviously, under APA review, we think they have an obligation to explain that denial. [00:08:45] Speaker 00: But yes, we would want them to either grant or deny without regard to the CGM data, which we think the record does not support the FAA's consideration of in this circumstance. [00:08:56] Speaker 04: sort of a funny situation where to get finality and give this court jurisdiction, you have to say the agency has made a final decision. [00:09:05] Speaker 04: In effect, it's denied the application. [00:09:09] Speaker 04: And so where is your client? [00:09:13] Speaker 04: So necessarily, I thought you were going to say either we have to reverse because it's arbitrary and capricious. [00:09:27] Speaker 04: and then let the agency figure out what it's going to do next with your client. [00:09:32] Speaker 04: That's why I'm not totally clear about [00:09:37] Speaker 04: If we have jurisdiction, what relief are you seeking? [00:09:41] Speaker 00: Well, that's essentially what we are asking for, Your Honor. [00:09:43] Speaker 00: And the reason is what we consider is that the FAA has denied the application for lack of CGM data. [00:09:51] Speaker 00: That's what it actually says in its brief at one point. [00:09:52] Speaker 00: It says, Mr. Friedman knows why his application has not been acted upon or granted, I think. [00:09:58] Speaker 00: That's what it says in its brief. [00:09:59] Speaker 00: And so ostensibly, the reason is that he has been denied for lack of CGM data under their [00:10:06] Speaker 00: FAA regulations. [00:10:09] Speaker 00: And at that point, this would be a situation in which a remand would essentially reverse that denial and revive the application so that it can be considered further on its merits. [00:10:18] Speaker 03: But if their action is to deny it, do you have to come back and then argue that that's arbitrary and capricious? [00:10:28] Speaker 00: Yes, that would be the further step down the road, Your Honor. [00:10:31] Speaker 00: That's not necessarily an issue that this court would have to take on now. [00:10:36] Speaker 00: What we do think the court should take on, though, is the fact that CGM is no longer an issue that is supported by the record. [00:10:43] Speaker 00: That request cannot be made, and they cannot deny his application because he did not submit the CGM data. [00:10:49] Speaker 00: That decision is arbitrary and capricious. [00:10:52] Speaker 04: What I'm trying to understand here is the regulations say, under the provision which your client is proceeding, that the surgeon has discretion. [00:11:03] Speaker 04: And furthermore, somewhere that the administrator, the FAA, can condition the granting of a new authorization on the results of subsequent medical tests. [00:11:16] Speaker 04: And it's not as though, at least in my view, [00:11:19] Speaker 04: The request is for a medical test that is irrelevant to the issue. [00:11:26] Speaker 04: And reasonable medical personnel, experts may disagree about the relevance of this, but the surgeon [00:11:37] Speaker 04: on whose decision our lives all depend is saying a very conservative position. [00:11:43] Speaker 04: I want everything. [00:11:44] Speaker 04: And he's not even saying that. [00:11:46] Speaker 04: He says, I want this one other standard procedure. [00:11:51] Speaker 04: And so to say it's arbitrary and capricious, we have to get to when the surgeon asks for [00:12:00] Speaker 04: additional medical information, he must explain why he needs that information. [00:12:09] Speaker 04: Is that the result of a reversal here? [00:12:12] Speaker 04: Especially, if I could just add, in view of your argument that the FAA has not developed, what, a protocol or guidance for the first class medical certificate? [00:12:27] Speaker 00: Well, Your Honor, we think that it's telling that the explanation is not in the record. [00:12:31] Speaker 00: That itself is arbitrary and capricious. [00:12:33] Speaker 00: And this is not a case in which the FAA has not had the opportunity to explain. [00:12:37] Speaker 00: Friedman has asked the FAA several times. [00:12:40] Speaker 00: You can see this on JA 31-41-15. [00:12:42] Speaker 04: Right, but I guess my point is, isn't it obvious? [00:12:47] Speaker 00: I'm sorry, I don't follow, Your Honor. [00:12:49] Speaker 04: Well, he wants a special certificate. [00:12:52] Speaker 04: he acknowledges he has a condition as to which the FAA has given special attention. [00:13:00] Speaker 04: The surgeon says, I appreciate the information you submitted, but I want data from this additional test. [00:13:11] Speaker 04: And would we be holding necessarily that's arbitrary and capricious? [00:13:18] Speaker 04: Because any time you ask for additional requests, a test, you have to tell us why. [00:13:24] Speaker 00: Well, Your Honor, we think that here, that discretion has to be exercised, obviously, within balance. [00:13:29] Speaker 00: And here, there are very clear balance. [00:13:30] Speaker 00: Section 4 of the Pilots' Bill of Rights addresses this precise scenario. [00:13:35] Speaker 00: It tells us that requests for information must be relevant to individuals' medical qualifications, and more importantly, aligned with present-day medical judgments. [00:13:44] Speaker 04: Well, you're not asking us to say that this test [00:13:48] Speaker 04: is not relevant, are you? [00:13:52] Speaker 00: Well, Your Honor, I think the record clearly supports that. [00:13:54] Speaker 00: The question here for this Court is whether or not the FAA has justified the medical relevance of this test. [00:14:00] Speaker 00: And the record evidence is uniformly in Mr. Friedman's favor. [00:14:04] Speaker 00: Everything in the record says that this is not relevant. [00:14:07] Speaker 00: It's less accurate than actual data that the FAA could ask. [00:14:10] Speaker 02: I realize that the FAA hasn't done this, but I'm just interested in your view of what would be a minimally adequate [00:14:17] Speaker 02: explanation. [00:14:18] Speaker 02: Could the FAA have said to Mr. Friedman, well, we have an outright ban. [00:14:23] Speaker 02: We're considering opening it a bit on a case-by-case basis. [00:14:26] Speaker 02: We also have a weighty safety obligation, and we haven't made a final determination on generally how we're going to deal with these cases. [00:14:33] Speaker 02: We're doing it very with baby steps. [00:14:36] Speaker 02: We want a lot of information now. [00:14:38] Speaker 02: We want more than what might satisfy us with respect to each incoming [00:14:44] Speaker 02: picture of how pilots with insulin-dependent diabetes operate generally. [00:14:50] Speaker 02: So we would like belt and suspenders. [00:14:53] Speaker 02: We would like continuous glucose monitoring as well as the other information that this person's prescribed protocol produces. [00:15:02] Speaker 02: Would that be purposeful and would that be an adequate explanation? [00:15:06] Speaker 00: Well, Your Honor, I think that it would depend on the request because, again, the question is medical relevance. [00:15:13] Speaker 00: I don't think anybody disputes that the FAA could ask for something like exploratory surgery just because it wants to know the answer. [00:15:20] Speaker 00: And so in that situation, we would say that the FAA has discretion to act, surely. [00:15:27] Speaker 00: It can create a protocol, it can make medically relevant requests, but it cannot make unjustified requests. [00:15:41] Speaker 02: What is provided [00:15:45] Speaker 02: I mean, can you get the historical information that CGM provides through a recording co-symmeter? [00:15:52] Speaker 02: It's a different kind of information, isn't it? [00:15:54] Speaker 02: You don't get the automatic, seamless path of data. [00:15:58] Speaker 02: You get data that the patient chooses to [00:16:02] Speaker 02: to trigger, no? [00:16:03] Speaker 00: That's correct, your honor. [00:16:05] Speaker 00: And the point is that that difference is material, that the glucometer readings are actually accurate, and that there are dips and spikes that can be reported by the CGM. [00:16:15] Speaker 00: That might be valuable for people trying to manage their diabetes, somebody, for example, that is going on a run all the time, right, who trains a lot and wants to know how their diabetes behaves as they're running or something like that. [00:16:26] Speaker 00: They're not going to stop every 15 minutes and prick their finger. [00:16:29] Speaker 00: What they're going to do is say, well, you know, I'd like to collect some data. [00:16:32] Speaker 00: I know the limitations of the data. [00:16:34] Speaker 00: And indeed, the FAA recognizes the limitations of the data. [00:16:37] Speaker 00: At J-54, when it requests the data from Friedman, it says, please submit this data for 90 days and make sure you calibrate your CGM at least three to four times a day. [00:16:48] Speaker 00: That in and of itself, we think, is an acknowledgment that this data is not rock solid. [00:16:54] Speaker 00: It is useful in some situations, but the record shows that it is not useful for this inquiry. [00:17:00] Speaker 02: I guess I'm trying to find out, is it your position that were the FAA to offer the kind of explanation that I suggested, would that be impermissible? [00:17:10] Speaker 02: You said, well, it would be impermissible to demand exploratory surgery. [00:17:13] Speaker 02: But I'm not, that's not my hypothetical. [00:17:15] Speaker 02: My hypothetical is, [00:17:16] Speaker 02: to demand continuous glucose monitoring data. [00:17:20] Speaker 02: Were they to do that? [00:17:21] Speaker 02: Is there anything in the FAA's regulations and the idea about medical relevance that's so individuated that it would be impermissible to request that? [00:17:31] Speaker 00: Well, Your Honor, so as I understand your hypothetical, just the fact that they are asking for data because they're trying to develop a protocol, it would still be impermissible to ask for the CGM because that is not a medically relevant [00:17:45] Speaker 00: request from Mr. Friedman. [00:17:51] Speaker 02: So they can't use individual applicants as a research tool? [00:17:54] Speaker 02: Because clearly it could be relevant to their policy, but that's why they have to go to the American Diabetes Association. [00:18:00] Speaker 00: That's correct, Your Honor. [00:18:03] Speaker 00: There are no further questions. [00:18:05] Speaker 04: Thank you. [00:18:12] Speaker 01: Good morning. [00:18:13] Speaker 01: Good morning and may it please the court. [00:18:14] Speaker 01: Amanda Sheridan for the FAA. [00:18:16] Speaker 01: The only decision that the federal air surgeon has made in this case is that he cannot proceed with a final determination on Mr. Friedman's request for a special issuance first-class medical certificate until he receives 90 days of continuous glucose monitoring data from Mr. Friedman. [00:18:34] Speaker 01: He has made no decision on the ultimate question, again, which is Mr. Friedman's ultimate request for an exemption from the medical standards in 14 CFR Part 67. [00:18:44] Speaker 02: Come on. [00:18:45] Speaker 02: I mean, the FAA knows that Mr. Friedman isn't going to provide CGM. [00:18:48] Speaker 02: He's made that clear. [00:18:49] Speaker 02: And his counsel in the letter that he sent asking for further information said, hey, and if you can't answer these questions, at least make a decision here. [00:18:58] Speaker 01: Your Honor, we know that now because he's filed a petition for review. [00:19:01] Speaker 02: It's in the letter. [00:19:02] Speaker 01: Well, he never clearly stated, Your Honor, that he was not going to provide the information. [00:19:08] Speaker 01: He did state, as counsel said, that it's not something that he has now. [00:19:13] Speaker 01: It's not something that his doctors have required him to have to manage his disease. [00:19:18] Speaker 01: And certainly, you know, [00:19:23] Speaker 01: there's an indication, perhaps, that he might not be willing to provide this information, but at the last point in time at which the federal air surgeon corresponded with him, you know, Mr. Freeman didn't make clear at that point in time when we reaffirmed our request for the data that he wasn't going to provide it. [00:19:43] Speaker 01: I think our doctors always operate on the [00:19:46] Speaker 01: on the assumption that anybody who is seeking, especially an exemption from the medical standards, will want to provide as much data as possible for us to make a decision on that point. [00:19:54] Speaker 03: Well, your letter said initially, if we don't get this in 60 days, it's going to be denied. [00:20:00] Speaker 03: Then it said, if we don't get it in 30 days, it's going to be denied. [00:20:04] Speaker 03: But that did not happen. [00:20:06] Speaker 03: How long can you leave him in limbo? [00:20:09] Speaker 03: I mean, is there any limit to how long you can just decline [00:20:16] Speaker 03: complete this decision? [00:20:20] Speaker 01: There are no specified time limits, Your Honor, either in the statute or in the regulations for the federal air surgeon to make a decision. [00:20:27] Speaker 01: However, in November of 2015, that is the first specific request that the federal air surgeon made to Mr. Friedman for the continuous glucose monitoring data. [00:20:38] Speaker 01: We didn't receive anything at the time that we issued him a renewal of his third class special issuance medical certificate in December 2015. [00:20:47] Speaker 01: And at that time, in the same letter, told him that we were still willing to consider his application for a first class special issuance. [00:20:56] Speaker 01: And because we'd requested 90 days worth of data at the earliest, we would think that if he was going to respond and we were operating under the assumption that he would, [00:21:06] Speaker 01: we would receive that data in probably February or March of 2016. [00:21:09] Speaker 02: Has the FAA ever said, or is it actually, let me ask first, is it the FAA's position that continuous glucose monitoring is, in the view of its doctors, medically indicated for Mr. Friedman? [00:21:22] Speaker 01: Your Honor, in the point of view of the federal air surgeon, the continuous glucose monitoring data is medically indicated for the purpose of making an aeromedical aviation safety decision. [00:21:34] Speaker 01: We understand that Mr. Friedman's doctors do not recommend this [00:21:38] Speaker 01: particular course of monitoring for his treatment. [00:21:41] Speaker 01: They feel that he is being well managed with the finger stick glucose test that he performs. [00:21:47] Speaker 01: But the federal air surgeon is looking for a more comprehensive picture about Mr. Freeman's glycemic management than those finger stick tests can provide. [00:21:55] Speaker 01: Where in the record does it say that? [00:21:58] Speaker 01: It does not, Your Honor, say that specifically in the record. [00:22:03] Speaker 01: The Federal Air Surgeon actually, through the Assistant Administrator for Aviation Safety, did communicate to Mr. Friedman that we will be requiring additional information beyond that which he submitted in support of his request for a third class special issuance in order to make a decision on his request for a first class special issuance. [00:22:24] Speaker 02: Why does the FBI want this information? [00:22:27] Speaker 02: What's going to show that a doctor's exam of this individual is saying he's really very carefully controlled? [00:22:36] Speaker 02: What more is this going to provide? [00:22:38] Speaker 01: The federal air surgeon is interested in looking at the 90 days worth of monitoring, which will show a near real time data of the fluctuations in Mr. Freeman's glucose level. [00:22:50] Speaker 01: They provide a stream of constant data points versus the intermittent snapshots that you would get from finger stick glucose testing. [00:22:57] Speaker 01: And it would be able to show the federal air surgeon over a period of time [00:23:01] Speaker 01: any insidious changes in Mr. Friedman's glucose level, changes such as a drop in blood sugar that perhaps would require mitigation of some type, but that Mr. Friedman may not have symptoms or awareness of and then be able to take those steps to mitigate that. [00:23:17] Speaker 01: And that's important when we're talking about allowing someone to operate outside of the medical standards and potentially have the ability to fly hundreds of passengers for a major airline. [00:23:29] Speaker 01: We've never done this before. [00:23:31] Speaker 01: We've only certified people to fly privately. [00:23:34] Speaker 01: And so we're taking a more conservative position here because obviously we tolerate a very low amount of risk when it comes to major airline operations. [00:23:43] Speaker 01: We can tolerate a little more risk when it comes to private pilot operations. [00:23:46] Speaker 03: But the agency did convene this expert panel, right, and that was something that the agency did in trying to assess risk, I'm assuming, for people who are insulin dependent. [00:23:59] Speaker 03: Yes, ma'am. [00:24:00] Speaker 03: And it seems to me from this record that the expert panel doesn't agree with the FAA's position that this is necessary. [00:24:14] Speaker 03: On what ground is the agency disagreeing with its panel? [00:24:21] Speaker 01: Your Honor, you are correct. [00:24:23] Speaker 01: The FA did ask for input from the American Diabetes Association in providing its expertise, which is in research into diabetes treatment and management, into making some recommendations for a future protocol. [00:24:36] Speaker 01: But that's just part of the deliberation here. [00:24:39] Speaker 01: That's part of the information that's being considered. [00:24:43] Speaker 01: reasonable medical minds can disagree. [00:24:45] Speaker 01: And while the ADA certainly has expertise in the research associated with diabetes in terms of the treatment of individuals with diabetes and in terms of advocacy for those individuals, it is the FAA that has expertise in aerospace medicine and aviation safety [00:25:01] Speaker 01: And it's to that expertise to which this court should defer in finding that it's a rational exercise of the federal air surgeon's authority to request this data. [00:25:10] Speaker 03: Did I misunderstand? [00:25:11] Speaker 03: I know that there were members of the ADA who were part of this panel, but I thought there were also other members who do have expertise in aeronautical medicine. [00:25:22] Speaker 03: Is that incorrect? [00:25:24] Speaker 01: No, Your Honor, even the FAA sat in on these discussions. [00:25:29] Speaker 01: They didn't actively participate, but they were at these meetings. [00:25:34] Speaker 01: So no, you're not entirely incorrect in that. [00:25:37] Speaker 01: There were, I believe, some individuals who did have some expertise in aerospace medicine. [00:25:42] Speaker 01: But the important distinction there is that [00:25:44] Speaker 01: It's the FAA who's been charged and delegated the authority by Congress to set medical standards, to set aviation safety regulations, and importantly to determine what is in the public interest when they're allowing someone to operate outside of that regulatory scheme. [00:25:57] Speaker 03: So is it the agency's position then that no matter who they convene and no matter what these experts say, ultimately they will make the decision. [00:26:07] Speaker 03: They don't have to follow what the experts tell them. [00:26:13] Speaker 01: Ultimately, it will be up to the federal air surgeon to make the final decision, obviously viewing all of the data that he has available to him, including the expert recommendations from the ADA panel that was convened. [00:26:25] Speaker 01: At this point in time, he does disagree with their position on whether continuous glucose monitoring has value in the aviation safety decision-making context. [00:26:35] Speaker 02: Can I ask you a question? [00:26:36] Speaker 02: Do you disagree with Mr. Chan that your regulations limit you to requesting medical information on what's medically indicated for the individual? [00:26:47] Speaker 01: No, Your Honor. [00:26:48] Speaker 01: You agree with that? [00:26:50] Speaker 01: No, we disagree. [00:26:51] Speaker 01: We disagree with that. [00:26:52] Speaker 02: To the extent that he's- Can you point me where I should look on the medical, on the sort of scope of medical information that you believe you're entitled to request? [00:27:04] Speaker 01: Yes, Your Honor. [00:27:08] Speaker 01: Certainly, if you take a look at the regulations in 67.413. [00:27:12] Speaker 02: Do you have an appendix site? [00:27:21] Speaker 02: Sorry, go ahead. [00:27:22] Speaker 01: Sorry, Your Honor. [00:27:24] Speaker 01: That regulation allows the federal air surgeon to ask for [00:27:32] Speaker 01: information that is rationally connected to the risks that might be posed by the medical condition that this person has, to the aviation safety risks that this person has. [00:27:50] Speaker 01: And so that allows federal air surgeon to ask for that information if he needs it to make a decision as to this person's medical fitness. [00:27:59] Speaker 01: And it also has a provision wherein if the individual does not provide it, that can be used as the basis for denying an application or if the person already holds a medical certificate to suspending or possibly revoking the certificate that they currently hold. [00:28:20] Speaker 02: Anything further? [00:28:21] Speaker 02: Oh, I have one question about what's sort of the order of operations in an application process? [00:28:28] Speaker 02: Because there's some information saying that if you have a medical exam, it's only good for six months, and then it expires. [00:28:35] Speaker 02: Do you have to get a medical exam and then apply, or do you apply and then you [00:28:41] Speaker 02: get scheduled for a medical exam or how does that all work? [00:28:47] Speaker 01: Certainly, Your Honor. [00:28:48] Speaker 01: So if one were applying, just applying for a medical certificate, an unrestricted medical certificate, you would go to an online website called MedExpress and you would fill out all of the application paperwork on that website. [00:29:02] Speaker 01: And then you would show up at an aviation medical examiner's office to take the physical examination portion, at which point, after that exam was completed, the aviation medical examiner would transmit that information to the FAA. [00:29:18] Speaker 02: In this case... And then you submit an application, or that is the application? [00:29:22] Speaker 01: That is the application. [00:29:24] Speaker 02: So you don't trigger anything before you go to MedExpress? [00:29:28] Speaker 02: You don't pull down some application and have that pending before you go to MedExpress? [00:29:34] Speaker 01: No, MedExpress would be the first point in time at which you start to complete the application process. [00:29:39] Speaker 01: You can complete your portion, the individual's portion of MedExpress, long before you ever go to a doctor for the examination. [00:29:47] Speaker 01: And if you never go to the doctor, then eventually that work that you have done will eventually [00:29:53] Speaker 01: expire from the system. [00:29:56] Speaker 01: But once you go to the doctor for the examination at that point, you've triggered the application. [00:30:00] Speaker 01: You have completed your application once you have the examination. [00:30:04] Speaker 02: And when relative to that process do you say, you know, I trained at X and so like school and I have so many hours and I'm experienced and not experienced? [00:30:14] Speaker 01: That would be during the MedExpress portion when you are home on your computer and you are filling out all of the relevant demographic information and medical history information on that portion of the application. [00:30:25] Speaker 02: And is that, that's the electronic profile that only lasts six months? [00:30:29] Speaker 01: No, Your Honor. [00:30:31] Speaker 01: So what Mr. Friedman has argued, he went on his own to an aviation medical examiner after completing the first part of the application on MedExpress. [00:30:39] Speaker 01: He went to an aviation medical examiner for an examination. [00:30:42] Speaker 01: And the aviation medical examiner properly deferred his application because Mr. Friedman has a condition which specifically disqualifies him from holding an unrestricted medical certificate. [00:30:54] Speaker 01: Now, had he been issued a medical certificate, that medical certificate for a first class, for an individual over the age of 40, would have a duration of six months. [00:31:06] Speaker 01: At the end of that six months, it would downgrade to the next class of certificate, which is the second class certificate. [00:31:12] Speaker 01: There are no time limits in either the regulations or the statutes supplying to the FAA that require in this context, which is he's asking for an exemption from the regulations, that require us to make a decision in X amount of days. [00:31:29] Speaker 01: If the federal air surgeon eventually receives the information that he has asked for and makes a decision on the ultimate question of whether or not Mr. Friedman's eligible for a first-class special issuance medical certificate, assuming that he [00:31:45] Speaker 01: does decide that that is the case, then if a new medical examination is needed, the federal air surgeon could simply direct Mr. Friedman to go and get a new one. [00:31:56] Speaker 01: There is nothing fatal to this process by the length of time that has elapsed between the time that Mr. Friedman went to an aviation medical examiner in this case and where we are now. [00:32:09] Speaker 03: Is there a different process for a third class certificate? [00:32:14] Speaker 01: Your Honor, the beginning of the process would be the same. [00:32:21] Speaker 01: The difference here is that there are two decisions that have been made by the federal air surgeon in this case. [00:32:30] Speaker 01: The first is that, based on the information that he had available to him, he found Mr. Friedman was eligible for a third-class special issuance. [00:32:38] Speaker 01: Mr. Friedman asked him to renew one that he already had, [00:32:41] Speaker 01: And based on the information that the federal air surgeon has now, he was able to make that decision and give him a third-class special issue. [00:32:48] Speaker 03: So it is possible to have this renewed without formally filing an application that says, I'm looking for a third-class certificate? [00:32:57] Speaker 01: Yes, Your Honor. [00:32:58] Speaker 01: There's instructions given in every authorization as to what someone must do in order to renew it. [00:33:02] Speaker 01: It may not always require a new medical examination. [00:33:08] Speaker 04: So just let me follow up here a little, and I realize this may be fairly speculative, but your brief takes the point that an impasse has been reached. [00:33:18] Speaker 04: The surgeon wants the information, petitioner's not going to provide it. [00:33:24] Speaker 04: Is that your position? [00:33:26] Speaker 01: Well, certainly, he's indicated to us by filing a petition for review that he does not wish to provide it, Your Honor. [00:33:31] Speaker 04: So to that... I just want to understand what you think the implications of impasse are. [00:33:36] Speaker 04: In other words, I can think of numerous situations where I'm trying to get something and the agency says, but I need something, and I say, I'm not going to provide it. [00:33:45] Speaker 04: Is that an impasse that gets a final order and gives us jurisdiction? [00:33:51] Speaker 04: Following up on that, were we to say we have jurisdiction, [00:33:55] Speaker 04: Were we to grant the petition, what do you see happening on remand in the context of what is now in the record? [00:34:08] Speaker 01: Well, to take the first part of your question, Your Honor, I don't believe the impasse at this point creates final agency action. [00:34:15] Speaker 01: I think that the agency certainly, had it received clear communication from Mr. Friedman that he did not intend to provide this information, the agency at that point could have explained that it was denying his request for an exemption and could have explained, provided some explanation as to why that was occurring. [00:34:33] Speaker 01: But the agency had no such opportunity in this case. [00:34:36] Speaker 04: Why didn't it just go out ahead and deny the application? [00:34:40] Speaker 04: Excuse me, Your Honor? [00:34:41] Speaker 04: Why did the agency not go ahead and deny the application? [00:34:46] Speaker 01: Um, well, your honor, uh, to the, um, in terms of why didn't the agency after the petition was for review was filed, um, the federal aviation or excuse me, the federal air surgeon didn't feel that it was appropriate to- No, no, no, excuse me. [00:34:59] Speaker 04: I didn't mean that. [00:35:00] Speaker 04: I meant that at the point this exchange is going back and forth and the final, um, communication says, you know, we're granting the third class renewal and [00:35:13] Speaker 04: we're treating your first class application as still pending. [00:35:16] Speaker 04: At that point, they could have said, but since you haven't provided us with the information, we're denying it. [00:35:22] Speaker 04: Does the regulatory scheme have some contemplation that once denied, then there's a bar to reapplying? [00:35:30] Speaker 04: I mean, what is the interest in keeping this pending this way? [00:35:33] Speaker 01: There is no bar, certainly, Your Honor, to reapplying once denied. [00:35:38] Speaker 04: So why wouldn't the agency just clear its docket? [00:35:41] Speaker 01: Well, Your Honor, that's something the agency could have done. [00:35:46] Speaker 01: It chose not to because it had asked for 90 days worth of data, and it was assuming that Mr. Freeman was going to provide it. [00:35:51] Speaker 04: So that's the implication from the communication that the agency had not clearly yet been told that [00:36:00] Speaker 04: the petitioner, or Mr. Friedman, was not going to provide the information. [00:36:04] Speaker 04: That's correct, Your Honor. [00:36:05] Speaker 04: I see. [00:36:06] Speaker 02: And where is your clearest statement of your reasons for insisting on CGM? [00:36:16] Speaker 01: Your Honor, we don't have a very clear statement of that in this record at this time, because we weren't able to develop that. [00:36:23] Speaker 01: The federal air surgeon is still seeking the information and still deliberating about how [00:36:30] Speaker 01: how it's going to be used in determining whether or not somebody is going to get an exemption. [00:36:41] Speaker 02: applicable APA standard of reason to say we are studying this, we are not confident yet that we have enough information to grant you an exemption, and therefore, in this period when we are still in a policy development phase, we are unwilling to grant. [00:37:01] Speaker 02: Without prejudice, we deny your application. [00:37:03] Speaker 02: Why is that not the reason? [00:37:07] Speaker 01: Why is that not the reason, or? [00:37:09] Speaker 02: Or is that? [00:37:11] Speaker 02: I mean, if you denied that, would it hold up under judicial review? [00:37:14] Speaker 01: I think it could, Your Honor. [00:37:16] Speaker 01: I think certainly if the federal surgeon had the opportunity to make a final denial in this case and to explain himself, that essentially is what he would say, is that I've determined that I need this information to move forward. [00:37:31] Speaker 01: And without this information, I cannot. [00:37:33] Speaker 04: So following up on the questions I was pursuing, if this went back to the agency and the surgeon pursuant to the court's opinion provided an explanation and said basically what you've been telling us this morning, then Mr. Friedman says, I'm still not going to provide it because it's arbitrary and capricious, this explanation. [00:37:57] Speaker 04: Then we're back here again on the same points that are being raised here today. [00:38:02] Speaker 04: Yes, Your Honor, I believe that would be the case. [00:38:04] Speaker 04: So how does this matter come to a close? [00:38:08] Speaker 04: I mean, this is an applicant who's trying to seek a job and presumably has bills to pay, you know, a life to live. [00:38:19] Speaker 04: And in fact, the agency's studying something because this is new. [00:38:24] Speaker 04: at least arguably not a good enough reason to keep him in limbo. [00:38:30] Speaker 04: I mean, you could simply say we're studying it. [00:38:33] Speaker 04: We think we need it. [00:38:35] Speaker 04: We're denying it. [00:38:37] Speaker 01: And that, I believe, is what would happen, Your Honor, if this case is remanded to the agency and if Mr. Friedman does not provide the information. [00:38:47] Speaker 04: So if we were to remand, we would have to be somewhat clear about the nature of the explanation that would be provided, if that's the rationale behind a remand? [00:38:59] Speaker 04: In other words, Judge Pillard suggested one type of explanation. [00:39:04] Speaker 04: I'll call it a bare minimum explanation. [00:39:06] Speaker 04: Another type of explanation would be a fairly thorough medical explanation or even more detailed along the lines you offered here today. [00:39:18] Speaker 04: Is that correct? [00:39:24] Speaker 01: that the court would have to provide guidance to that? [00:39:27] Speaker 04: I'm just not clear how this case moves ahead, all right? [00:39:30] Speaker 04: And what the petitioner has said, send it back and tell the agency to make a decision in 30 days. [00:39:38] Speaker 04: If he doesn't make a decision in 30 days or provide us with this explanation to make a decision, he still doesn't have the license, and he's back here. [00:39:49] Speaker 04: And that's why I asked counsel. [00:39:52] Speaker 04: You're requesting that we make this determination, as it were, that the surgeon general must provide, or the air surgeon must provide some sort of, what, individualized, detailed explanation before it can deny. [00:40:18] Speaker 01: Well, certainly not before it can deny, Your Honor. [00:40:20] Speaker 01: In the process of denying and communicating the denial, it would be appropriate to provide an explanation for the reason. [00:40:26] Speaker 04: Well, what I'm thinking of is it goes back, and the Surgeon General comes up with explanation A. And the petitioner says, that's no good. [00:40:32] Speaker 04: So the surgeon says, the air surgeon says, here's explanation B. The petitioner says, that's still no good. [00:40:38] Speaker 04: We're going to go back to court. [00:40:40] Speaker 04: So he says, well, I'll give you explanation C. [00:40:45] Speaker 04: Anyway, all right. [00:40:47] Speaker 04: Thank you, Your Honor. [00:40:48] Speaker 04: Thank you. [00:40:50] Speaker 04: Counsel for Petitioner. [00:40:53] Speaker 00: Thank you, Your Honor. [00:40:54] Speaker 00: In my brief time, I'd like to make three brief points. [00:40:58] Speaker 00: The first is that to Judge Brown's questions, there were medical experts that were aviation medical experts at the panel. [00:41:05] Speaker 00: You can see them clearly on the cover at JA 368. [00:41:08] Speaker 04: At or part of? [00:41:10] Speaker 00: I don't know if they're technically part of the five or the seven that are considered, but they are listed on the cover. [00:41:16] Speaker 00: They participated. [00:41:17] Speaker 00: And moreover, I would point out that the ADA has experience with the FAA. [00:41:21] Speaker 00: The third class protocol that was developed in the mid-90s was with the help of the ADA. [00:41:26] Speaker 00: So it's not like the ADA is just sort of doing this in a vacuum. [00:41:29] Speaker 00: They know how this medical evidence bears on [00:41:33] Speaker 00: things that the FAA is considering. [00:41:35] Speaker 00: The second point is that with respect to the regulations and the discretion, I would point the court to 14 CFR 67.401C. [00:41:45] Speaker 00: That's addendum 14 of the blue brief where it states that [00:41:49] Speaker 00: These air surgeons may consider the person's operational experience and any medical facts that may affect the ability of the person to perform. [00:41:57] Speaker 00: And moreover, beyond that, I would say at Addendum 8, you have the Pilots' Bill of Rights, which specifically addresses this situation. [00:42:04] Speaker 04: The third point I would make... I don't see how C helps you. [00:42:08] Speaker 00: Well, Your Honor, we think that is evidence of the constraint that the FAA is putting on itself. [00:42:14] Speaker 00: And while it does say may, at the same time, and I would point out that this is the special issuance regulation itself. [00:42:20] Speaker 00: And so it is suggesting that we will only ask questions. [00:42:24] Speaker 00: That's the way I read the regulations. [00:42:25] Speaker 00: I see. [00:42:25] Speaker 00: And beyond that, we have, of course, the Pilot School of Rights, which is Congress's command. [00:42:29] Speaker 00: The third point is, with respect to the remedy and the state of the record, I would point the court to the Safe Extensions case, which is cited in both briefs. [00:42:37] Speaker 00: And there you have a situation where the FAA's explanation surfaces for the first time in an appendix to its appeal brief. [00:42:45] Speaker 00: And the court very clearly says, this record is exceedingly thin, but it's sufficient for review. [00:42:51] Speaker 00: Either the agency hasn't identified its reasons for making this decision, or it has no reasons [00:42:57] Speaker 00: Either way, that violates the APA. [00:43:00] Speaker 00: And here, I think, today, we still have not heard at the council articulate any reason why this application is being held. [00:43:09] Speaker 00: And while reasonable medical minds can disagree under the APA, if there's no justification for their disagreement and there is not in this record, that is a violation of the APA. [00:43:19] Speaker 00: And for those reasons, we would ask the court to grant the petition. [00:43:22] Speaker 02: Thank you. [00:43:22] Speaker 02: Thank you, Your Honor. [00:43:23] Speaker 02: Let me just ask you, how long has the American Airlines job remained open? [00:43:28] Speaker 00: Unfortunately, Mr. Friedman had been furloughed, as you know, and he had had a right of return. [00:43:33] Speaker 00: It actually expired in August, and so he no longer has a right of return as of last month, unfortunately. [00:43:39] Speaker 04: Thank you. [00:43:40] Speaker 04: We'll take it under advisement.