[00:00:06] Speaker 00:
the Federal Aviation Administration.

[00:00:08] Speaker 00:
Mr. Chen for the petitioner, Ms.

[00:00:09] Speaker 00:
Gardner for the respondent.

[00:00:14] Speaker 01:
Judge Kittle, don't we need to thank Mr. Zucker?

[00:00:20] Speaker 03:
Mr. Zucker, my apologies.

[00:00:22] Speaker 03:
My apologies, you were appointed by the court to represent the appellant and we appreciate your assistance.

[00:00:31] Speaker 03:
Thank you, Judge Henderson.

[00:00:58] Speaker 04:
Good morning, and may it please the court.

[00:01:00] Speaker 04:
When considering an ITDM pilot for first-class medical certification, the essential test in the FAA's view is whether that individual is at increased risk for incapacitation due to hypoglycemia.

[00:01:13] Speaker 04:
Five hypoglycemia and two aviation medical experts studying that exact question at the FAA's request agree that Friedman is the quintessential candidate who poses no such risk.

[00:01:24] Speaker 04:
The FAA relied on that expert judgment when it decided to certify ITDM pilots in all classes, but it has since unjustifiably turned its back on that judgment in denying Friedman's application for lack of CGM data.

[00:01:37] Speaker 04:
Not only does a costly and invasive CGM demand make no sense in light of Friedman's impeccable glycemic track record.

[00:01:46] Speaker 02:
say that 90 days of CGM could not possibly shed light on the ultimate decision before the FAA?

[00:02:00] Speaker 04:
Yes, Your Honor.

[00:02:01] Speaker 04:
In this circumstance, we think that is true.

[00:02:03] Speaker 04:
And to be clear, we're not asking for a broad protocol.

[00:02:06] Speaker 04:
We're asking for the FAA to look at the record in this case.

[00:02:10] Speaker 03:
Wait, wait.

[00:02:10] Speaker 03:
You need to answer Judge Friedman's, Judge Williams' question.

[00:02:14] Speaker 03:
Sure.

[00:02:14] Speaker 04:
That's not what he asked you.

[00:02:16] Speaker 04:
Well, I think the answer is that based on the evidence in the record, the CGM would provide no greater certainty.

[00:02:24] Speaker 02:
So we do think that the individualized... There clearly is evidence in the record showing that for some purposes,

[00:02:32] Speaker 02:
CGM is useful, not necessarily the purposes advanced by the FAA, but nonetheless some purposes in shedding light on variability, variability both in frequency and degree of hypoglycemic attacks.

[00:02:57] Speaker 02:
Piloting a commercial plane is obviously a heavy responsibility, and could there not be data shown by the 90 days that would cast Mr. Friedman's otherwise exemplary record in a slightly different light?

[00:03:17] Speaker 04:
Well, we don't think so, Your Honor, because here what we have is the ADA saying, and I think your comment touched on this, that it's not necessarily for this purpose.

[00:03:27] Speaker 04:
And the experts, the leading experts in the field have assembled to study this question.

[00:03:31] Speaker 04:
They have said very clearly that CGM data is neither necessary nor appropriate.

[00:03:37] Speaker 04:
And I think that in this particular circumstance, when you have a... Well, slow down, slow down.

[00:03:42] Speaker 02:
I don't think they've established

[00:03:44] Speaker 02:
or that there's any clear consensus that there's no circumstances under which it's necessary or appropriate.

[00:03:51] Speaker 02:
There's the Battellini study in the record beginning at page 697 in which it seems clear that people following CGM data were able to hold their

[00:04:07] Speaker 02:
hypoglycemia up, I guess is the right adverb for it, to prevent extremities of hypoglycemia.

[00:04:16] Speaker 02:
They weren't without it.

[00:04:18] Speaker 02:
Now whether, I grant you the connection between that and grant or denial of a certificate is not as clear, but it does suggest that, for example, CGM, a requirement of CGM

[00:04:36] Speaker 02:
while he's flying could be useful.

[00:04:40] Speaker 02:
I should say the FAA doesn't mention that.

[00:04:42] Speaker 04:
Well, Your Honor, we think that there's a considerable difference here between the question about whether or not CGM might be useful when he's flying and whether or not he has met the standard here.

[00:04:53] Speaker 04:
And again, the standard here is whether or not he is at increased risk of hypoglycemia

[00:04:58] Speaker 04:
Sorry, increased risk of incapacitation due to hypoglycemia.

[00:05:03] Speaker 02:
Increased risk is a somewhat obscure term, right?

[00:05:09] Speaker 02:
Increased vis-a-vis what baseline?

[00:05:12] Speaker 04:
Well, Your Honor,

[00:05:13] Speaker 04:
Right now, well, our understanding from the FAA, and they haven't been exactly clear.

[00:05:17] Speaker 04:
They've used different terms.

[00:05:18] Speaker 04:
They've used general population.

[00:05:20] Speaker 04:
They've used first-class pilots.

[00:05:22] Speaker 04:
But we think that under any conception he would meet it.

[00:05:24] Speaker 04:
And this is the reason why we think that statement is logical.

[00:05:28] Speaker 04:
The FAA says that statement is simply untrue or that it's supported by unsupported conjecture.

[00:05:34] Speaker 04:
But what I would say is that what you have here is you have a baseline of first-class pilots.

[00:05:40] Speaker 04:
And the FAA doesn't know anything about those pilots, right?

[00:05:44] Speaker 04:
You can't catch the pilot who, you know, goes out and exercises strenuously and then doesn't eat and then gets in the cockpit.

[00:05:51] Speaker 04:
That's actually happened to a non-ITDM pilot before and caused an incapacitation event.

[00:05:57] Speaker 04:
On the other side, we know so much about ITDM pilots that are certified because they go through rigorous testing.

[00:06:04] Speaker 04:
And in particular here, Friedman has gone through rigorous testing.

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And I think he's been uniquely vetted here.

[00:06:10] Speaker 04:
And in this particular circumstance, we think that based on the individualized assessment, when you have the leading experts coming to this question and looking at his data and seeing over 11 months that he has zero hypoglycemic records and not a single red flag identified in the FAH January 2017 letter, that there should be some justification before a costly and invasive CGM demand is made in this particular circumstance.

[00:06:38] Speaker 02:
A slight diversion, I'm afraid, but it is pertinent.

[00:06:44] Speaker 02:
Both you and the amicus have said that there are seven individuals who have had CGM whose

[00:06:53] Speaker 02:
applications for certification remain in limbo?

[00:06:58] Speaker 02:
Correct.

[00:06:59] Speaker 02:
And what is there, I know it's not in the record because there's no citation in the record, is there something that by going on the FAA website one could verify or not that suggestion?

[00:07:15] Speaker 04:
My understanding, Your Honor, is that those applications are private because they contain medical information.

[00:07:24] Speaker 04:
And so I don't believe there's a publicly available database.

[00:07:27] Speaker 04:
But the ADA, my understanding is that the ADA has been contacted by these pilots.

[00:07:31] Speaker 04:
It's actually up to almost a dozen pilots now who have submitted CGM data.

[00:07:36] Speaker 04:
My understanding is that the oldest runs back to April 2015.

[00:07:39] Speaker 04:
That's when the application was filed, that there's been no action on those.

[00:07:43] Speaker 04:
But no, we don't think that is publicly verifiable.

[00:07:47] Speaker 04:
But our understanding is that those people have reached out to me.

[00:07:50] Speaker 02:
Another question that haunts this case is this very staunch opposition to Mr. Friedman's having 90 days of CGM and their references to cost

[00:08:04] Speaker 02:
There are references to inaccuracy, but that simply is not the driving force.

[00:08:12] Speaker 02:
Is the cost so high?

[00:08:14] Speaker 04:
I mean... Well, yes, and we think that some of the studies discuss this.

[00:08:18] Speaker 04:
I can find a JA site for you if you'd like.

[00:08:21] Speaker 04:
But my understanding is that initially this costs $1,000 when it's not medically indicated.

[00:08:26] Speaker 04:
It's not covered by insurance.

[00:08:28] Speaker 04:
So out of pocket, you would first have to buy the technology and the sensors.

[00:08:34] Speaker 04:
And the sensors don't last for very long either, is my understanding.

[00:08:37] Speaker 04:
They last for maybe a week, maybe a little more.

[00:08:40] Speaker 04:
And those need to be replaced constantly, and thus they need to be bought constantly.

[00:08:44] Speaker 04:
And that can be quite expensive.

[00:08:45] Speaker 04:
So my understanding... But you did say that seven pilots have done that, right?

[00:08:51] Speaker 03:
What's that, your own?

[00:08:53] Speaker 03:
You did say that seven people have done that.

[00:08:57] Speaker 04:
Yes, Your Honor.

[00:08:59] Speaker 04:
There are people with CGM data out there.

[00:09:01] Speaker 04:
And CGM data can be used by a pilot who chooses to control their diabetes that way.

[00:09:06] Speaker 04:
And so just the fact that others do doesn't mean that Friedman would not incur this cost.

[00:09:13] Speaker 03:
I want to get your... Are you done with your questions?

[00:09:16] Speaker 02:
For the minute.

[00:09:19] Speaker 03:
Let me try to get at the questions that Judge Williams was asking a little differently.

[00:09:24] Speaker 03:
So you say in your brief there's nothing this time around that wasn't in the previous record that this court found inadequate, right?

[00:09:34] Speaker 03:
So one of the things, what the agency says is that, and now I'm reading from their letter to your client, that notwithstanding these improvements, quote, hypoglycemia remains common and frequently goes unrecognized by finger stick tests.

[00:09:57] Speaker 03:
Right?

[00:09:58] Speaker 03:
Now, that wasn't in the previous record.

[00:10:02] Speaker 03:
And my question is, do you disagree with that?

[00:10:06] Speaker 03:
Well, as a general principle, no, Your Honor.

[00:10:09] Speaker 04:
But what I would say to that is that when they talk about that concept in the brief, they cite to a study at JA 692.

[00:10:19] Speaker 04:
And that study, and they attach a footnote to it, and this is the one that said 62.5% of people, right?

[00:10:28] Speaker 04:
That study, if you read it, those are people, and these are the words from the study, who had inadequate metabolic control.

[00:10:35] Speaker 04:
Those are people who had inadequate metabolic control, who had difficulty controlling their diabetes.

[00:10:41] Speaker 04:
And so just to make it concrete here for the finger stick versus the CGM for the hypoglycemia question, what you would see

[00:10:48] Speaker 04:
And this is the American Diabetes Association's point at its brief on page 20.

[00:10:55] Speaker 04:
That finger stick data will expose incompatible glycemic management that shows you that somebody is not fit to fly.

[00:11:03] Speaker 04:
What you would see if you had severe hypoglycemia or if you had recurrent hypoglycemia, you would see that in the record.

[00:11:12] Speaker 04:
Your blood glucose would fall.

[00:11:14] Speaker 04:
and you would have a reading.

[00:11:17] Speaker 03:
And this is particularly absurd.

[00:11:19] Speaker 03:
That isn't what the studies show.

[00:11:21] Speaker 03:
So look, take out the government brief if you would.

[00:11:25] Speaker 03:
Do you have it there in front of you?

[00:11:28] Speaker 03:
Okay, I'm on page 26 of their brief.

[00:11:33] Speaker 03:
Okay?

[00:11:34] Speaker 03:
Midway through the first full paragraph, they have three sentences I want to ask you about.

[00:11:46] Speaker 03:
a study of 686, right?

[00:11:50] Speaker 03:
Which is what it says.

[00:11:52] Speaker 03:
It says self-monitoring of blood glucose monitoring, this is with finger sticks, are often not sufficient to detect and reflect very, right?

[00:12:01] Speaker 04:
Yes, Your Honor.

[00:12:02] Speaker 03:
Okay.

[00:12:02] Speaker 03:
So do you disagree with that study?

[00:12:05] Speaker 03:
I mean, you didn't in your brief, you didn't challenge that study.

[00:12:08] Speaker 03:
No, no, no, Your Honor.

[00:12:12] Speaker 03:
All right, and then it goes on, and episodes of both hyper and hypo can be missed and not factored into treatment decisions, and it cites something at Joint Appendix 645.

[00:12:28] Speaker 03:
Correct.

[00:12:29] Speaker 03:
Which does say that, exactly that, right?

[00:12:33] Speaker 03:
Yes.

[00:12:34] Speaker 03:
And then it says, thus, CGM is a useful tool.

[00:12:38] Speaker 03:
for detecting previously unrecognized hypoglycemic episodes, and it cites a study that supports that.

[00:12:45] Speaker 04:
Yes, and, Your Honor, that last study is the one that I was talking about.

[00:12:51] Speaker 03:
So tell me, what am I missing here?

[00:12:54] Speaker 03:
What they're saying is that the traditional, is that individuals with this type of diabetes who use the finger stick method,

[00:13:09] Speaker 03:
that what the continuous monitoring shows is that people use that still have undetected hypoglycemic episodes.

[00:13:20] Speaker 03:
and that that's why they need the test.

[00:13:22] Speaker 03:
That's why they need the 90-day data.

[00:13:25] Speaker 03:
That's their position, right?

[00:13:26] Speaker 04:
Yeah, that is their position.

[00:13:28] Speaker 04:
Well, our position, as that very study cited in that very paragraph in the brief explains, those are people who already don't recognize their hypoglycemia.

[00:13:38] Speaker 04:
So let's say you have hypoglycemia unawareness, right, which is one of the things they're talking about, and that's what

[00:13:46] Speaker 04:
Those were the types of people that were in those studies.

[00:13:49] Speaker 03:
You're talking about the study that said 62 percent, right?

[00:13:52] Speaker 03:
Correct.

[00:13:53] Speaker 03:
But what about these other studies that I just mentioned to you?

[00:13:57] Speaker 03:
They aren't limited by that characteristic.

[00:14:00] Speaker 04:
Well, Your Honor, it doesn't say either way in those studies, but what I would say is that those studies aren't exclusive to the fact that, and they don't exclude the fact that finger sticks can show

[00:14:14] Speaker 04:
incompatible hypoglycemia levels when you have somebody who is hypoglycemia aware.

[00:14:21] Speaker 04:
And we think here, again, we should go back to the data that they actually have.

[00:14:25] Speaker 04:
If he actually had incompatible readings, you have 11 months of data that the experts have looked at, hypoglycemia experts that

[00:14:33] Speaker 04:
You know, treat patients every day to figure out whether or not they have unrecognized hypoglycemia, whether or not they should change their treatments, and how to best manage their diabetes to avoid these types of harms.

[00:14:43] Speaker 04:
Those people have looked at it and said, look, he has zero, zero in those 11 months readings.

[00:14:49] Speaker 04:
And if those experts are saying that if we have... And that's based on the finger stick.

[00:14:58] Speaker 03:
that even people who use the fingerstick method can be unaware of a hypoglycemic episode.

[00:15:06] Speaker 04:
That's their point, isn't it?

[00:15:10] Speaker 04:
Well, yes, Your Honor, but we would also, again, we would expect, if that were true in Mr. Friedman's case, we would see some evidence of that by his fingerstick, and there is none here.

[00:15:20] Speaker 03:
It's just really hard, you know, in our, in Friedman 1, Friedman 1 was easy because the agency gave absolutely no reason for what it asked for.

[00:15:35] Speaker 03:
It just included CGM in a list.

[00:15:38] Speaker 03:
This time around, they've given a reason and they have data that supports it.

[00:15:45] Speaker 03:
And it's, what's the basis this court has for second guessing that judgment under the circumstances of this record?

[00:15:55] Speaker 03:
I mean, we're not doctors.

[00:15:58] Speaker 03:
All we can do is insist that an agency provide a reason and evidence in support of that reason, right?

[00:16:05] Speaker 03:
That's correct.

[00:16:06] Speaker 03:
So if you were writing an opinion, sending this back again, what would it say?

[00:16:11] Speaker 04:
Your honor, what it would say is that on this record, and I think that is the key here, whatever the justification that the FAA has provided in its January 2017 letter and on the record, and I guess all the studies that it has brought to bear here, whatever that tells you about what CGM might do,

[00:16:30] Speaker 04:
in a hypothetical situation.

[00:16:32] Speaker 04:
In this particular situation where you have somebody who has been uniquely vetted by a panel of experts, it has been, it's not just his treating physician coming and saying, well, you know, here's the information, here's my study.

[00:16:44] Speaker 04:
This opinion has then been sent to seven experts who all agree in that circumstance.

[00:16:50] Speaker 04:
They haven't pointed to a single reason why CGM would do anything further to, you know.

[00:16:58] Speaker 03:
You're not asking for a remand for a further explanation.

[00:17:02] Speaker 03:
You want this court to order the FAA to grant the commercial license in this case.

[00:17:08] Speaker 03:
That's correct.

[00:17:09] Speaker 02:
I take it though, consistent with your position, would be remand saying, you say, you, FAA say, that you make case-by-case determinations, but here you've absolutely refused to make a case-by-case determination.

[00:17:27] Speaker 02:
Instead you have referred to averages, generalities, and Mr. Friedman falls outside those averages and generalities.

[00:17:40] Speaker 04:
That's correct, Your Honor.

[00:17:41] Speaker 02:
Let me pose this question for you.

[00:17:45] Speaker 02:
Suppose we read the agency as saying, yeah, we didn't take Mr. Friedman's specific data into account, but we're

[00:17:57] Speaker 02:
working in an area where there is high variability, both as to frequency and degree, and it seems prudent in that context to, and particularly as CGM for 90 days is not terribly burdensome, to have that additional screen.

[00:18:22] Speaker 02:
They didn't say that, but I suppose we charitably read their letter saying that.

[00:18:30] Speaker 02:
Would that be reversible?

[00:18:33] Speaker 04:
Well, yes, Your Honor, because I don't think it's undisputed here that CGM is incredibly burdensome.

[00:18:40] Speaker 04:
It would be costly and it would be invasive.

[00:18:44] Speaker 02:
You say it's in the record, but the briefs don't talk about the cost.

[00:18:49] Speaker 04:
Well, that's correct, Your Honor, but this was a subject that was covered in Treatment 1.

[00:18:56] Speaker 04:
But I'm happy to find a JA site for the comment.

[00:18:59] Speaker 02:
Okay, that would be good, yeah.

[00:19:00] Speaker 04:
But not now, not now.

[00:19:02] Speaker 03:
I just want to be really clear about this.

[00:19:04] Speaker 03:
You're not asking for a remand for further explanation of the CTM requirement.

[00:19:09] Speaker 03:
You want, I believe you say at the end of your brief, correct, that you want this court to order the FAA to grant petitioner a commercial license on this record?

[00:19:21] Speaker 02:
That's correct.

[00:19:22] Speaker 03:
Correct.

[00:19:22] Speaker 03:
Okay, thank you.

[00:19:24] Speaker 02:
But you're not rejecting the alternative of a remand for a reasoned decision?

[00:19:29] Speaker 02:
Well, Your Honor... That is to say, if the decision before us is unreasoned, that is a characteristic

[00:19:36] Speaker 04:
Well, yes, your honor, but we do think that given the way that this litigation has developed and the fact that we've already had Friedman one Friedman one had a very clear mandate To justify CGM and we think we made this argument very clearly in the last round During Friedman one we said based on this record and we think that this that in order to comply with that mandate at the very least Before we're talking about CGM in the abstract The FAA should have dealt with Friedman's record on its own terms

[00:20:06] Speaker 04:
All right.

[00:20:07] Speaker 04:
Thank you.

[00:20:08] Speaker 01:
We'll hear from you.

[00:20:09] Speaker 01:
Oh, wait.

[00:20:10] Speaker 01:
Hold on a second.

[00:20:11] Speaker 01:
Sure.

[00:20:11] Speaker 03:
Go ahead.

[00:20:12] Speaker 01:
Can you hear me?

[00:20:13] Speaker 01:
Yes.

[00:20:13] Speaker 03:
Yes.

[00:20:14] Speaker 01:
OK.

[00:20:15] Speaker 01:
First, Mr. Chen, you mentioned the development of this case.

[00:20:19] Speaker 01:
It's odd to me, when I read treatment one, that your client asked for the first class medical certificate.

[00:20:29] Speaker 01:
And when the SAI said, all right, we'll consider it, your client then said, oh, but you can't consider it.

[00:20:35] Speaker 01:
And then that caused the FAA to say, well, we will reconsider the fact that we don't consider it.

[00:20:43] Speaker 01:
That's something that troubles me.

[00:20:46] Speaker 01:
But my question to you is, am I correct that there is a gap in your client's 500 plus fingertips, that only 2% of those were done at night, and that episodes of hypoglycemia occur

[00:21:05] Speaker 01:
at night, obviously, and he would be flying at night.

[00:21:08] Speaker 01:
Now is that a gap that I'm incorrect about?

[00:21:12] Speaker 04:
Well, Your Honor, Mr. Friedman is sleeping at night, so he's not up checking his glucose, but he would not be sleeping while he's flying at night.

[00:21:23] Speaker 04:
That's, I guess, the answer I would say.

[00:21:25] Speaker 04:
And beyond that, the FAA really has not sort of focused in on this nighttime problem as a concern.

[00:21:32] Speaker 04:
And I think it's for the basic reason that he will not be, even though he may be flying at night,

[00:21:38] Speaker 04:
he won't be sleeping at night.

[00:21:40] Speaker 04:
And it's the sleeping that may cause any gaps if there are so.

[00:21:47] Speaker 01:
Is that in the record?

[00:21:51] Speaker 01:
In other words, I might misunderstand you.

[00:21:53] Speaker 01:
The hypoglycemia is more apt to occur when he's sleeping?

[00:22:00] Speaker 04:
Well, Your Honor, what the studies show is that hypoglycemia is something that occurs at night because people are not checking.

[00:22:09] Speaker 02:
And they're also not eating, which would repel the hypokrasemia, right?

[00:22:18] Speaker 01:
All right, thank you.

[00:22:20] Speaker 03:
If there are no further questions.

[00:22:22] Speaker 03:
Thank you.

[00:22:22] Speaker 03:
We'll hear from the government.

[00:22:32] Speaker 00:
May I please support Casey Gardner on behalf of the FAA.

[00:22:37] Speaker 00:
Mr. Friedman has asked the federal air surgeon to grant him a special issuance first-class medical certificate because he does not meet the medical standards in FAA's Part 67 regulations.

[00:22:49] Speaker 00:
So this case is a challenge to the federal air surgeon's discretionary authority to issue medical certificates to individuals who are otherwise unqualified to fly on the face of our Part 67 regulations.

[00:23:01] Speaker 00:
And here, because Mr. Friedman has refused to provide the information necessary for the federal air surgeon to make that determination to the satisfaction of the federal air surgeon that Mr. Friedman can fly a commercial airliner without endangering public safety, the federal air surgeon did not abuse his discretion by denying Mr. Friedman's request.

[00:23:24] Speaker 02:
What are the possible CGM readings and where would they take the agency?

[00:23:32] Speaker 02:
I mean, you have apparently seven or more people who've done the CGM in limbo.

[00:23:41] Speaker 02:
So is there any reason for us to believe that any reading, any CGM reading, no matter how exculpatory as it were, would lead to the FDA issuing a certificate?

[00:23:55] Speaker 00:
It absolutely would, Your Honor.

[00:23:57] Speaker 00:
That's the precise reason that we are requesting the CGM.

[00:24:00] Speaker 02:
Again, what we have... What is the reason you're requesting it?

[00:24:03] Speaker 02:
Because there is some level... What about the setup?

[00:24:08] Speaker 03:
Are there seven others?

[00:24:10] Speaker 03:
What are the circumstances?

[00:24:12] Speaker 00:
I don't know the exact circumstances of any other pending cases.

[00:24:16] Speaker 00:
I know that there are some and that we are actively reviewing the CGM data of other candidates.

[00:24:21] Speaker 00:
I don't know the precise procedural posture of those other individuals.

[00:24:25] Speaker 03:
Go ahead, Steve.

[00:24:26] Speaker 03:
I'm sorry.

[00:24:28] Speaker 03:
Your question was, what would you do?

[00:24:30] Speaker 02:
Is there a clue anywhere in this record?

[00:24:33] Speaker 02:
as to what sort of reading, CGM readings, would lead to issuances of a certificate.

[00:24:42] Speaker 00:
Right, so as we stated in our letter of response, or denial letter, I should say, to Mr. Friedman, what we're going to be looking for with the CGM is evidence of glycolymic control and stability.

[00:24:53] Speaker 00:
So Mr. Friedman's assertion is that he is so well managed with his

[00:24:57] Speaker 00:
with his condition that he has no risk of incapacitation of having a hypoglycemic event.

[00:25:04] Speaker 02:
All we have from Mr. Friedman are these... Hypoglycemia is a matter of degree.

[00:25:10] Speaker 02:
So have you conceived of what degree of hypoglycemia would rule him out?

[00:25:19] Speaker 00:
No, there's no strict numerical thresholds here.

[00:25:21] Speaker 02:
There are no standards.

[00:25:22] Speaker 02:
There are no standards here.

[00:25:23] Speaker 00:
That's correct, because what we're trying to do here is get a comprehensive picture of Mr. Friedman's glycemic variability.

[00:25:29] Speaker 00:
What we have are an average of 4.1 finger stick tests in a given day, right?

[00:25:35] Speaker 00:
And there's 24 hours in a day.

[00:25:36] Speaker 00:
So we have a lot of missing data.

[00:25:38] Speaker 00:
We have a lot of holes.

[00:25:39] Speaker 00:
And we can't rely on conjecture here to fill in those gaps.

[00:25:44] Speaker 02:
There are a lot of studies in the record.

[00:25:48] Speaker 02:
in suggesting that 90 days of CGM would enable a better prediction as to the risk of hypoglycemic attacks down the road for years and years.

[00:26:07] Speaker 02:
In other words, it seems to me there are studies in the record, particularly the Battellini study, that suggest that it might make sense for the FAA to say, we'll give you your certificate, but only on the condition that you have continuous CGM while you're piloting.

[00:26:24] Speaker 02:
But you don't say that at all.

[00:26:26] Speaker 02:
That's some anterior decision that you'll make.

[00:26:29] Speaker 02:
which won't be followed up, or at least there's no indication it'll be followed up by a condition of continuous CGM.

[00:26:36] Speaker 02:
And correct me if I'm wrong, you have not pointed to a single study suggesting that 90 days of CGM facilitate a better prediction about years into the future, even months into the future.

[00:26:52] Speaker 00:
Well, I have two responses to that.

[00:26:53] Speaker 00:
The first is we did state in our letter to Mr. Friedman that we intend to evaluate the potential use of CGM as a risk mitigation during operations in commercial piloting.

[00:27:04] Speaker 00:
So we are considering using CGM as a safeguard measure while the airman is in the cockpit.

[00:27:10] Speaker 00:
However,

[00:27:11] Speaker 00:
The defining feature of a special issuance certificate, which is what we're talking about here, is that they're first, discretionary, but second, they have conditions.

[00:27:21] Speaker 02:
Usually we ask agencies to exercise not to abuse their discretion.

[00:27:25] Speaker 00:
Absolutely.

[00:27:26] Speaker 00:
And to that point, the federal air surgeon here doesn't have unfettered discretion.

[00:27:30] Speaker 00:
The standard is in the regulation.

[00:27:32] Speaker 00:
And I should note that the standard isn't risk of incapacitation.

[00:27:36] Speaker 00:
The standard is clearly stated in the special issuance regulation.

[00:27:40] Speaker 00:
It's 14 CFR 67401A, and it states that at the federal agent's discretion, he may grant a certificate to an individual

[00:27:49] Speaker 00:
If, and that's the if, that individual can show to the federal air surgeon that he can pilot an aircraft without endangering public safety.

[00:27:59] Speaker 00:
So in order for the federal air surgeon to issue Mr. Friedman a certificate here, Mr. Friedman must show to the federal air surgeon that he can exercise a commercial airline, or he can pilot a commercial airline.

[00:28:10] Speaker 02:
Let's go back a second.

[00:28:13] Speaker 02:
Let's assume the burden is on Mr. Friedman to meet this task.

[00:28:18] Speaker 02:
The agency requires a particular screening device, but it does not identify in the record, so far as I can see, any study suggesting that the particular device is useful for making this predictive judgment.

[00:28:39] Speaker 00:
That's correct, because it's only the federal air surgeon that is making this particular judgment.

[00:28:44] Speaker 00:
We're talking not about whether CGM is necessary for clinical treatment.

[00:28:49] Speaker 02:
What we're trying to... I understand that, but you are insisting on a particular type of data.

[00:28:58] Speaker 02:
But you appeared to acknowledge to me that nothing in the record supports the proposition that these data would facilitate a prediction as to the

[00:29:10] Speaker 02:
risk of a hypoglycemic attack in the future.

[00:29:17] Speaker 02:
If that's true, it seems utterly pointless to have this monitoring.

[00:29:24] Speaker 00:
Well, the CGM's purpose is that it gives continuous monitoring.

[00:29:29] Speaker 02:
I understand that.

[00:29:30] Speaker 02:
And therefore, I can see, if you were saying, give you your certificate, Mr. Friedman, if but only if you accept the condition that CGM must go on continuously while you're in the air.

[00:29:45] Speaker 02:
It's hard for me on this record to see any problem with that.

[00:29:49] Speaker 02:
If you don't say that at all, you just say, we won't look at you, because you haven't had this monitoring, which, and correct me if I'm wrong, you acknowledge there's nothing in the record supporting the idea that it has predictive value for this future freedom from or exposure to hypoglycemic attack.

[00:30:15] Speaker 02:
It is useful for detecting unrecognized hypoglycemia, so when an individual... Right, right, yes, yes, but you do not say that it is useful for predicting the future risk of or telling the degree or frequency of future hypoglycemic attack.

[00:30:37] Speaker 01:
Let me jump in here because I think the second page of the letter does

[00:30:44] Speaker 01:
Dr. Berry says, the TGM data that we have requested will be viewed for evidence of glycemic control instability.

[00:30:54] Speaker 01:
Now, if that turns out to show glycemic control instability, I think the implication is, and it's premature to say it, I guess he could have said, and if it turns out that that shows

[00:31:11] Speaker 01:
glycemic control and stability, then we will require you to have CGM from now on, or at least while you're piloting a commercial aerial.

[00:31:22] Speaker 02:
Is that a correct reading of the letter?

[00:31:23] Speaker 00:
Yes, that is correct.

[00:31:24] Speaker 00:
We state explicitly that we intend to use CGM as a risk mitigation during operations requiring... Yeah, I understand that.

[00:31:31] Speaker 02:
But the other question is, the proposition shows the absence of a

[00:31:39] Speaker 02:
a risk of hypoglycemic attacks, you will issue the certificate with this condition.

[00:31:46] Speaker 00:
That is our intention.

[00:31:47] Speaker 00:
What we're trying to do... You say it's your intention.

[00:31:49] Speaker 02:
People often speak of intention very carefully to mean they're not actually committed to that proposition at all.

[00:31:57] Speaker 00:
Should Mr. Friedman's CGM data

[00:32:01] Speaker 00:
corroborate his assertion that he doesn't show an extreme risk of hypoglycemia.

[00:32:08] Speaker 00:
There's no strict thresholds here.

[00:32:11] Speaker 00:
There's no number that's going to be specifically disqualifying.

[00:32:13] Speaker 00:
And it's important to note also here that we're not using the CGM alone in an isolation.

[00:32:18] Speaker 00:
We're using it

[00:32:20] Speaker 00:
as a supplement to all of the information that we already have.

[00:32:24] Speaker 02:
I understand.

[00:32:24] Speaker 02:
I'm a great fan of belt and suspenders.

[00:32:27] Speaker 02:
But the question is whether the suspenders are contributing.

[00:32:32] Speaker 02:
And if there is a meaningful affirmation by the FAA that

[00:32:42] Speaker 02:
below some, as yet unspecified, obviously, but below some reasonable level.

[00:32:51] Speaker 02:
If the risk is below some level, FAA will issue the certificate.

[00:33:02] Speaker 02:
It will?

[00:33:03] Speaker 02:
You're saying it will?

[00:33:03] Speaker 00:
Yes, that is why we are requesting the data, to evaluate whether he can fly a commercial aircraft.

[00:33:08] Speaker 02:
Well, yeah, you say that, and I take your word for it.

[00:33:13] Speaker 02:
And maybe the court will take your word for it.

[00:33:18] Speaker 02:
It leaves something of a mystery about the elusive seven.

[00:33:22] Speaker 00:
Sure, but the question that's important to realize here is that the question is could the federal air surgeon have certified Mr. Friedman based on the information that he had available to him?

[00:33:34] Speaker 00:
Did he make a rational decision based on what he was presented?

[00:33:38] Speaker 00:
And all he was presented with was finger sticks, which we have said repeatedly to Mr. Friedman and to the ADA

[00:33:45] Speaker 00:
we do not believe show an adequate risk assessment.

[00:33:48] Speaker 02:
We don't believe that you can adequately determine... The difficulty with that is that, at least one of the difficulties is that you never have said what would be an adequate risk assessment.

[00:33:59] Speaker 00:
Right?

[00:34:00] Speaker 00:
Right.

[00:34:01] Speaker 00:
So we're new in this game.

[00:34:05] Speaker 00:
We've never

[00:34:05] Speaker 00:
certified an individual with insulin-treated diabetes for first-class certificate.

[00:34:11] Speaker 00:
We were not even considering these individuals in 2015.

[00:34:14] Speaker 00:
Now we are trying to evaluate these individuals on a case-by-case individualized basement.

[00:34:19] Speaker 00:
So we are trying to work with Mr. Friedman to gather the information that we need to make a competent risk assessment.

[00:34:26] Speaker 00:
It's a two-way street.

[00:34:27] Speaker 00:
We have to gather enough information from Mr. Friedman to corroborate his assertion that he doesn't pose a risk to aviation safety.

[00:34:35] Speaker 03:
Would I be accurately describing the FAA's position as follows, if I said?

[00:34:41] Speaker 03:
The data petitioners submitted about his individual situation is not adequate because it's all based on finger stick assessment.

[00:34:49] Speaker 03:
And CDM data in the record shows that even that people with that type of diabetes who use finger stick still have undetected and variable hypoglycemic levels, right?

[00:35:02] Speaker 03:
That's one.

[00:35:03] Speaker 03:
Yes.

[00:35:04] Speaker 03:
And number two, that if he's able to show through CGM data, 90 days presumably of no, that it's totally under control during those 90 days, that there aren't events, right, hypoglycemic events, that under those circumstances, the agency might consider granting a license.

[00:35:24] Speaker 03:
Is that true?

[00:35:24] Speaker 03:
That is correct.

[00:35:26] Speaker 02:
Let me ask you this.

[00:35:27] Speaker 02:
Sure.

[00:35:31] Speaker 02:
No events.

[00:35:34] Speaker 02:
Now in the record, there's the 70 level.

[00:35:38] Speaker 02:
And then at least one doctor says that, in fact, 66 is perfectly fine.

[00:35:44] Speaker 02:
So will one drop below one moment, below 70, be fatal?

[00:35:51] Speaker 00:
No.

[00:35:51] Speaker 00:
As I said before, there is nothing that's specifically exclusive here.

[00:35:55] Speaker 00:
We're not looking at the data for the purpose of trying to keep Mr. Friedman from getting a certificate.

[00:36:00] Speaker 00:
We're using it to corroborate his statement.

[00:36:02] Speaker 00:
What he's given us at this point is insufficient.

[00:36:05] Speaker 00:
So we're going to review the data, again, not in isolation.

[00:36:08] Speaker 00:
So there's not one data point that's going to be exclusive.

[00:36:11] Speaker 00:
If there's an aberrant data point, we have experts that are competent enough to see that.

[00:36:16] Speaker 00:
And we're also going to be using it in combination with the finger sticks that he's already provided.

[00:36:23] Speaker 00:
Because he can continue to use his finger stick for treatment as he wants to.

[00:36:27] Speaker 00:
Again, we want to be clear that we're not telling Mr. Treatment how to treat his own medical condition.

[00:36:32] Speaker 00:
They can be used simultaneously.

[00:36:35] Speaker 00:
we're going to be looking at the data to ensure that there aren't any unrecognized instances, because again, there's a safety risk here.

[00:36:42] Speaker 00:
Hypoglycemia can cause issues with cognition, with motor skills, with memory, with executive functions, things you need to fly a plane.

[00:36:53] Speaker 00:
And if we can't be sure on the face of the evidence that we have before us that Mr. Friedman isn't having unrecognized incidences, then we cannot certify him in the interest of public safety.

[00:37:04] Speaker 00:
We would not be doing our statutory duty here.

[00:37:08] Speaker 02:
The amicus brief and the petitioners' reply brief both allude to these seven

[00:37:21] Speaker 02:
who have made no progress or no detectable progress after submission of the CGN data.

[00:37:29] Speaker 02:
Did those passages in those briefs catch your eye and raise any curiosity in you about these seven?

[00:37:42] Speaker 00:
Yes.

[00:37:42] Speaker 00:
I mean, what I can say is we're working on it.

[00:37:45] Speaker 00:
I mean, here, what we're trying to do is make sure that the people we certify aren't posing a safety risk.

[00:37:53] Speaker 02:
It seems to be asserted in the briefs that submission of the CGM data has been followed by silence.

[00:38:02] Speaker 02:
And I guess that's not completely inconsistent with your working on it, as you say.

[00:38:08] Speaker 02:
Some of them date from 2015.

[00:38:10] Speaker 02:
It is at least puzzling that

[00:38:14] Speaker 02:
You know, I do apologize.

[00:38:18] Speaker 00:
I don't have any personal knowledge of the status of those pending cases.

[00:38:23] Speaker 00:
You know, I'm familiar with the facts here, however, and what I can say is that we intend to review Mr. Friedman's CGM data to verify his statement that he's extremely well managed, sufficient that he doesn't pose a risk when he's in the cockpit.

[00:38:40] Speaker 03:
I mean, okay, I just have one question.

[00:38:43] Speaker 03:
Um, when I was going through your discussion, I mean, in your brief, um, with Mr. Chen, um, about the, uh, um, value of CGM, um, we talked about this, uh, study you mentioned at footnote seven.

[00:39:02] Speaker 03:
Do you know what I'm talking about?

[00:39:04] Speaker 03:
Do you have your brief there?

[00:39:05] Speaker 03:
I do.

[00:39:06] Speaker 03:
Why don't you grab it?

[00:39:08] Speaker 00:
Page.

[00:39:08] Speaker 00:
Are we on your honor?

[00:39:10] Speaker 03:
Well, footnote seven, it's at.

[00:39:14] Speaker 03:
Okay, I can.

[00:39:15] Speaker 03:
Page 26.

[00:39:16] Speaker 03:
Yeah, it's page 26, first, midway through the first full paragraph.

[00:39:22] Speaker 03:
Well, that's where the text is.

[00:39:25] Speaker 03:
I'm looking at footnote seven.

[00:39:28] Speaker 03:
Do you have it there?

[00:39:29] Speaker 03:
Yes, I do.

[00:39:29] Speaker 03:
OK.

[00:39:30] Speaker 03:
So it cites this study which found that CGM detected unrecognized hypoglycemia in 62% of the type 1 diabetes.

[00:39:44] Speaker 03:
And there's a study at 692, right?

[00:39:47] Speaker 03:
So when I asked Mr. Chen about that, he said, well, I think what he said was that that study isn't really relevant because the subjects of that study were people who had

[00:39:57] Speaker 03:
uncontrollable hypoglycemic events.

[00:40:02] Speaker 03:
It doesn't apply to someone like Petitioner here.

[00:40:08] Speaker 03:
What did you think about what he said about the irrelevance of that study?

[00:40:14] Speaker 00:
I mean, the study shows that CGM has a utility.

[00:40:17] Speaker 00:
That was the purpose of things.

[00:40:19] Speaker 03:
But he said it was with a different class of diabetics.

[00:40:25] Speaker 00:
Right.

[00:40:26] Speaker 03:
Is that true?

[00:40:27] Speaker 00:
You know, Your Honor, I apologize.

[00:40:28] Speaker 00:
I don't recall the exact facts of that study.

[00:40:31] Speaker 00:
However, the purpose of including this study was not to draw an exact parallel to Mr. Friedman.

[00:40:36] Speaker 00:
The first time this case came before this court, you said that we didn't have anything in the record to support our Contention Act.

[00:40:42] Speaker 00:
We looked at the issue again and we pulled a body of literature that supports our positions here, that CGM is useful.

[00:40:49] Speaker 00:
It is helpful to ascertain whether or not an individual is having unrecognized hypoglycemic events.

[00:40:55] Speaker 00:
Now, admittedly, the ADA may disagree.

[00:41:02] Speaker 00:
But it's the FAA's aeromedical judgment here that is entitled to deference.

[00:41:06] Speaker 00:
It's not for the ADA or Mr. Friedman to tell the federal air surgeon what information he needs to do his job correctly.

[00:41:14] Speaker 00:
These are matters of aeromedical safety.

[00:41:18] Speaker 00:
They're uniquely within the institutional competence of the FAA.

[00:41:23] Speaker 02:
You do know that under State Farm,

[00:41:25] Speaker 02:
agencies are expected to link their conclusion to the data they rely on.

[00:41:33] Speaker 02:
And I've always understood that to mean pretty specifically.

[00:41:37] Speaker 02:
And your brief comes close to that.

[00:41:40] Speaker 02:
The letter doesn't come remotely towards it, right?

[00:41:44] Speaker 02:
It has a big general conclusion, says there are a lot of studies, and go look at them.

[00:41:53] Speaker 00:
State Farm also says that the agency's decision will be upheld as long as the agency path can be reasonably discerned.

[00:42:01] Speaker 03:
And it can be from this letter.

[00:42:02] Speaker 03:
Your client could have made the path much easier to discern in this case by simply putting into its letter the three sentences you have in your brief with the citations.

[00:42:13] Speaker 00:
I don't disagree with that point.

[00:42:17] Speaker 00:
However, the letter does identify the safety issue present.

[00:42:21] Speaker 00:
We said why we need what we're concerned about.

[00:42:23] Speaker 00:
It explains why the finger stick tests are insufficient and it explains why we need the CGM and we explain what we're going to do with it.

[00:42:33] Speaker 03:
Judge Henderson, did you have any other questions?

[00:42:38] Speaker 03:
Yes?

[00:42:38] Speaker 03:
OK.

[00:42:40] Speaker 03:
Thank you.

[00:42:40] Speaker 03:
Mr. Chen, at any time?

[00:42:45] Speaker 03:
You can take two minutes.

[00:42:50] Speaker 03:
Thank you, Your Honor.

[00:42:51] Speaker 03:
I won't take this out of your two minutes.

[00:42:54] Speaker 03:
Can you just tell me once again why this study and the footnote, why we shouldn't consider that as supportive of what the agency has done?

[00:43:01] Speaker 04:
Well, Your Honor, I think you can take the FAA's concession to start, that this is not an exact parallel, and they actually don't think this study was.

[00:43:07] Speaker 03:
But why don't you just tell me why you don't think?

[00:43:09] Speaker 04:
Well, Your Honor, we think that when you have somebody, so first of all, the study subjects people

[00:43:17] Speaker 04:
Right?

[00:43:18] Speaker 04:
Study subjects, I'm sorry, that have inadequate metabolic control.

[00:43:23] Speaker 04:
I see.

[00:43:24] Speaker 04:
These are people that already we know will have unrecognized hypoglycemia.

[00:43:29] Speaker 04:
And so applying the study in the abstract we think makes no sense.

[00:43:33] Speaker 04:
And again, the FDA has just said it's not exact parallel, and we think there needs to be a tie here.

[00:43:39] Speaker 03:
We'll go ahead with your points.

[00:43:41] Speaker 04:
And just to finish that point, Mr. Freeman is not, we think, your average patient, again.

[00:43:46] Speaker 04:
One one quick housekeeping matter the cost site would be at J a 722 And if I can make two brief points as well the first being that the FAS council has also conceded that there really is no link here and

[00:44:01] Speaker 04:
to predictive value, and to the extent that they cite studies in their brief, we think they completely over-read them.

[00:44:07] Speaker 04:
It's one thing to say that if you have a series of pictures showing which way a soccer ball might be flying, you know where that soccer ball is going to land.

[00:44:15] Speaker 04:
It is a whole other thing to say, what is his risk when he gets into the cockpit?

[00:44:20] Speaker 04:
There is no study that makes that leap.

[00:44:23] Speaker 04:
The last very brief point I've made in my last 30 seconds is that as to the remedy, I'd like to be clear that, you know, if this court is not comfortable remanding for the FAA to grant the certificate outright, we do think that, you know, a remand for further explanation, we think taking CGM off the table would be sensible if it hasn't been justified here.

[00:44:45] Speaker 03:
But at the very least... Wouldn't the consequence of that be to order the medical certificate granted?

[00:44:51] Speaker 03:
Well, Your Honor, if... I mean, I read your brief carefully.

[00:44:54] Speaker 03:
You asked for this court to order the FAA to grant the medical certificate.

[00:45:00] Speaker 03:
And if we sent it back and said, well, you know, you need to give us more information about CGM and why it would be useful,

[00:45:07] Speaker 03:
And if they can't produce it, isn't the immediate consequence of that that your client gets his license?

[00:45:12] Speaker 04:
It gets a certificate?

[00:45:13] Speaker 04:
We would think that on this record, yes.

[00:45:16] Speaker 04:
But at the same time, if the FDA were to have some other explanation, then I suppose you could offer it at that time.

[00:45:22] Speaker 04:
Thank you.

[00:45:23] Speaker 02:
I'd just like to make one remark before the lawyers go.

[00:45:26] Speaker 02:
And that is, in preparing an appendix, it would be awfully helpful if you allowed the readers to see the page numbers.

[00:45:35] Speaker 02:
A large number of the page numbers are blacked out almost entirely.

[00:45:41] Speaker 02:
It makes it a tremendously difficult exercise to find what's being cited.

[00:45:47] Speaker 02:
It doesn't seem much to ask.

[00:45:49] Speaker 03:
May I add, assuming, I'm not sure I can speak for Judge Anderson, but I believe the panel is unanimous on that point.

[00:45:58] Speaker 03:
Thank you, Your Honor, and our apologies.

[00:46:01] Speaker 03:
Case is submitted.

[00:46:02] Speaker ?:
Thank you.