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Case number 24-1105 et al.

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Michael Solons, Petitioner versus Federal Aviation Administration.

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Mr. Nagy for the petitioner, Mr. Carver for the respondent.

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Mr. Nagy, you may proceed when you're ready.

[00:00:17] Speaker 04:
Thank you, Your Honors.

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And I believe that for two minutes for rebuttal, that's still permissible to reserve.

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All right, thank you.

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May it please the court, Brandon Nagy on behalf of the petitioner and pilot, Michael Solons, who's with us

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gallery in the front row today.

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Mr. Salons is a rare example of a pilot who did everything right.

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In 2018, after the death of his father, he began experiencing severe anxiety.

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Rather than continue flying as a commercial airline pilot, he recognized the distractions and the difficulties the anxiety was causing, and he sought treatment and help.

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He self-grounded, reported his condition,

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took himself out of the air and sought that help.

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Over the years, he tried a variety of antidepressants under the guidance of his personal doctors and the FAA's doctors, Dr. Levinson and, or Levitt, pardon me, and Dennison, two FAA HEM-certified doctors, a psychiatrist and a forensic psychologist, and ultimately found that Remron, the brand name of Maritzipan,

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was the antidepressant most effective for his particular genome and gave him the least side effects, the least negative effects, and frankly, cured and resolved his depression.

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After that, after more than a year of self-grounding, after multiple evaluations, including by the FAA doctors, which he was required to pay for himself, and it doesn't create a doctor-patient confidentiality, these are the FAA's experts,

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They gave him a clean bill of health and both Dr. Dennison and Levitt agreed and recommended that he could continue pursuing FLY to be ungrounded.

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So he sought that.

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He approached the FAA and asked for his medical clearance back.

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While the FAA, proving no good deed, doing the right thing, doesn't go unpunished, said no.

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They have said no for four years, and only after this appeal was filed in April did the FAA finally issue what they characterized as the air surgeon denial, finally explaining it's because you're on Remron, period.

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They don't use the word blacklist, but they say it's unapproved, it's disapproved,

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and as they've been saying for four years, if you want a chance at flying again, get off Rimron.

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The advice and diagnoses and treatment and clinical records you've produced over four years be damned.

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None of that matters because you're on Rimron.

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Now the air surgeon in its denial has explained why that is.

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Is it because Mr. Salon has some sedative or a sleepiness, a drowsiness, a somnolent side effect?

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No.

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It is because the air surgeon has said, well, certain general studies show that some patients taking Remron have that side effect.

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And they cited to one general study with 54% of patients exhibiting that side effect.

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Yet in the very next line of the denial, the air surgeon notes, oh, but by the way, on the high dosage, the dosage Mr. Solanz is on,

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Only 14% of patients report that compared to 10% placebo.

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I know we were talking a lot about statistics in the last argument.

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And here, I don't think the court needs to delve into them as completely, except to say that rather than look at Mr. Salon's pertinent medical records and the conclusions of the FAA's own certified and directed to trained physicians,

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The FAA has simply said, sorry, that's it.

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Get off the one medication that works for you or you'll never fly again.

[00:04:05] Speaker 02:
I appreciate all of those arguments and certainly the situation and the delay.

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But I think the starting point, right, is that this is a special issuance license.

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And the FAA is essentially saying,

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a 54% risk is too high.

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And we are going to approve some other drugs that work in different ways with much lower risks.

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But just as a sort of baseline starting position, 54% is too high of a risk.

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And so what is our basis to disagree with that?

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Well, Your Honor, your basis is the regulation itself.

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It requires the FAA in a 67.401C to provide professional consideration of all available information regarding the person, the pilot.

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They have to examine Mr. Salonza's medical records.

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And moreover, your point about 54% is too high.

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Well, there's two things to that.

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The one, as I had just mentioned, on the dosage that Mr. Solanz is on, the FAA has already acknowledged only 14% compared to 10% placebo.

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So already they've undercut their own argument.

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But more to the point, the FAA, the other SSRIs, antidepressant drugs, the FFA has approved.

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And again, when I say approved, let's think of this as the difference between a green list, something like Tylenol that doesn't raise any flags,

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a gray list, such as the other antidepressants, Lexapro, Zoloft, things like that, which are eligible still for a special issuance, where the FAA has said, it's OK that you're on those.

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You can't get a general certificate because of their sedative effects, the potential in the general population.

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But we will look at you individually, examine your medical records, and institute an entire year-long SSRI protocol, a protocol Mr. Salons has been through multiple times,

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passed and performed by Dr. Dennison, again, the FAA hems doctor.

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So that's where the arbitrary and capricious part comes in, where the FAA has created this extra blacklist, unpublished, without any rulemaking, without any comment, that says certain pilots on certain medications are prohibited, period.

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They will not be treated the same as their fellow pilots who get individualized treatment.

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So that, I think, is the

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Prox of your argument is you're arguing that he did not get individualized consideration.

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That's correct.

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But I take the FAA to be saying, well, he did.

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He applied under the special issuance provision.

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And I take it that's the only provision that's at issue before us.

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That's correct.

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And they looked at his records, and they decided

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No.

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And now you're making what I understand to be sort of a procedural claim that they didn't actually do an individualized special issuance review.

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They made a categorical determination based on the characteristics of Remrah.

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Am I right that that is your position?

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Yes, it is.

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And in that regard, this case is exceptionally close to the Irwin case that this court decided just two years ago.

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In Irwin, and it's briefed fully in our brief, but in Irwin, a pilot who had a special issuance that prohibited the use of alcohol inadvertently ate some pulled chicken that had been cooked in alcohol and failed a test the next day.

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Eventually, this court overturned the FAA when the FAA insisted that, sorry,

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One failed test, regardless of all of the evidence submitted, including forensic toxicologists and everything else, a mountain of evidence Irwin submitted about his individual case and proving with no evidence to the contrary by the FAA.

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But the FAA held the line and said, sorry, nope, we have a bright line.

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We're not going to look at your individual evidence.

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We're just going to say, sorry, special issuance, you're done.

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That's exactly what we have here, where it's not about whether or not Mr. Solons is safe to fly on Remron, because the mountain of evidence, four years of medical evidence, shows he is, that he has no sedative effects.

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He is not one of the ones who suffers from it.

[00:08:23] Speaker 02:
There's sort of a medical question embedded in this, which I'm not sure anyone addresses, which is, does a history, assume he does have great evidence that over a period of time, he has not suffered this side effect.

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Does that mean he's unlikely to, in the future, that the risk has gone to zero?

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Or does it mean on a drug that generally has, if we assume the number is 54%, there's still some meaningful risk that the side effect could start?

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I didn't see anyone want to address that.

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Right.

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And Your Honor, that's because there is a little bit of a medical part of that.

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First, though, I want to correct 54% is not accurate because the FAA's own studies show the dosage he's on, it's only 14%.

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And so that's already a big difference.

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But with respect to, this isn't something like Benadryl.

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The studies that are in the record talk about this.

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It's not something where the semolans or the drowsiness is unpredictable.

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Indeed, the trucker study about commercial truck drivers at the FAA sites in its denial, saying there was sort of an increased risk, talks specifically about this and comes to the conclusion, taking a single large dose at night before bed essentially alleviates any of the negative, the sedative side effects that they're not found anymore.

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That's the recommendation of this study.

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And I believe the recommendation page with that conclusion is on page 671 of the record.

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And again, this is the study that the air surgeon cited in its denial as a reason why Remron is apparently a blacklist as compared to the other SSRI antidepressants, which also have sedative effects anywhere between 30 and 45% in the general population, which

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you know, it's okay, it's less than 54%, but that still means 70 or even 65 pilots out of 100 could be having, you know, a risk according to the FAA's logic.

[00:10:17] Speaker 02:
And yet they still do.

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The conditionally approved SSRIs have side effect rates of 30 to 35%.

[00:10:24] Speaker 02:
Where is that?

[00:10:26] Speaker 04:
Those are in the studies that are attached at the end of the record, the FAA studies.

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it brought in the point being the FAA has used hyperbolic language in its briefing and in their surgeon denial to say there's a significantly more risk well you know I'm not sure that that's a very significant difference risk but more to the point it doesn't give the individualized assessment that the regulation calls for and the FAA has produced no rational basis

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and no reasoned explanation as to why it is treating remeron differently and why under the same special issuance regulation the FAA can pick and choose which antidepressants a pilot is allowed to or is entitled to and given an individualized assessment of their own medical history to determine if that risk ever manifests.

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as opposed to Mr. Solanz, who has been denied the individual review, which would show that with more than four years of use, the cog screenings done multiple times by the FAA doctors show no risk, no difference between the general pilot population.

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And really, that gets to the crux of it, because I recognize 54% may sound like more than half, you know, general population.

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But that also means you're grounding 46 out of 100 pilots for no good reason.

[00:11:50] Speaker 01:
Well, let me ask you, counsel.

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I just want to be clear.

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When I read the record, and maybe I misunderstood it, I don't see a basis where you're saying that the FAA never considered your client on an individual basis.

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All right, it goes on and on and on about your client's circumstances.

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And it acknowledges that your client has had these other

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medical evaluations and opinion.

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But then it says, consistent with its statutory obligation, that it has classified this particular drug in a certain way.

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And it's simply not going to move off that because of its concern about

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You know, what it says, and we're not physicians, are the inheriting qualities of the medication, and that there are all kinds of other things that aren't like this.

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And your client's position, as I understand it, is that what the FAA failed to do, and let me be clear that I understand the position, is that

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It didn't, the surgeon didn't critique each of the evaluations that your client proffered or produced for the record.

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In other words, I don't see the record in this case as substantiating a granting of the petition on the grounds that the agency failed to consider

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the issues before it and failed to consider the evidence that was presented relevant to those issues.

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But rather, along the lines of Judge Garcia's question, consistent with its obligation about medical safety, air safety, it's simply not going to approve this drug.

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And you'd say there was no rule making, there was no nothing, but at least

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Now we have a statement by the FAA as to its position.

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And we may not agree with it in the sense that your client is saying he disagrees with it.

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But what does the court say?

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In other words, it's not the typical arbitrary and capricious situation.

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They looked at some studies.

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And the surgeon says, here's where I come out.

[00:14:51] Speaker 04:
Yes, Your Honor.

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So I can understand that is certainly the position the FAA is trying to advance.

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However, this court does have a reasoned way of approaching the case.

[00:15:01] Speaker 04:
And in Irwin.

[00:15:03] Speaker 01:
Tell me what that is precisely.

[00:15:05] Speaker 04:
Yeah, so precisely.

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So in Irwin, in this court only two years ago, it explained that the court's role is to determine whether the FAA has

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examined the relevant data, articulated a satisfactory explanation that does not fail to consider important aspects of the problem.

[00:15:22] Speaker 01:
That's what my question went to.

[00:15:24] Speaker 01:
That's the standard.

[00:15:26] Speaker 04:
Yes, Your Honor.

[00:15:27] Speaker 01:
On these FAA.

[00:15:30] Speaker 04:
Correct.

[00:15:30] Speaker 04:
And Your Honor.

[00:15:31] Speaker 01:
Yeah.

[00:15:33] Speaker 04:
Right.

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And in Irwin, the FAA did the same thing it's doing here now.

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where it said, sorry, we have a bright line rule.

[00:15:40] Speaker 04:
It doesn't matter.

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Any evidence you've put will give lip service that you submitted it.

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Because in Irwin, the FAA did include a sentence saying, we note you submitted medical evidence to the contrary.

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But it did not analyze it.

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It did not give any explanation.

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It merely said,

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We have a rule that any failed alcohol test means your special insurance is canceled and you're forever ineligible, period.

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That's the problem here.

[00:16:03] Speaker 02:
You may still have a compelling argument, but Irwin is very different, right?

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Irwin was, you have a

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positive alcohol test yet specific evidence showing that it wasn't because he drank anything that he shouldn't have and this case is all about.

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Maybe the FDA should have said more, but it would be totally consistent to say, we are going to have a categorical rule against Remeron because we're not going to take the time when the risk is so high, they would say, to do case-by-case evaluations.

[00:16:41] Speaker 02:
We will for other drugs, SSRIs, which have been around longer, and we understand how they work.

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And we've decided to approve them in a cautious, case-by-case way.

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We just haven't gotten there yet with this tetracyclic type of drug.

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That's not, in other words, you could justify a categorical rule.

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And the very nature of that categorical rule would be we don't.

[00:17:08] Speaker 02:
They could justify not leaving any more individual evidence.

[00:17:11] Speaker 02:
They had administrability reasons and better science than you think they have.

[00:17:15] Speaker 04:
Well, Your Honor, I would say that could be the case, but that's not the case here.

[00:17:20] Speaker 04:
The FAA did not develop any of that in the record.

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It certainly didn't even make an administratability argument.

[00:17:25] Speaker 04:
The FAA has produced no reason to justify a blanket ban on Remron and a refusal to conduct the individualized assessment that the regulation requires on pilots on Remron, other than to say,

[00:17:38] Speaker 04:
Using hyperbolic language that there's a significantly greater risk, while in the same breath or well this next sentence same paragraph but next sentence.

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Noting that actually the risk on the dosage that Mr salons is on the higher dosage gets down to only being a 4% difference between the placebo group.

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And again, I can't stress this enough.

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The FAA has not adduced or even claimed any evidence that this risk is something that's sort of intermittent, that drowsiness comes and goes.

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The opposite is true.

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The FAA has developed its SSRI protocol to do a longitudinal study of each airman on an antidepressant.

[00:18:17] Speaker 04:
The protocols discussed at length in our brief, and that's what Dr. Dennison based his evaluations on,

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He followed that same SSRI protocol.

[00:18:27] Speaker 02:
Did you develop the argument and the facts that, for example, you were saying this is a 54% rate, but in fact, we have a study showing it's 14% and also providing them information about the drugs they have approved that shows it's 30% to 35% in order to really tee up this kind of

[00:18:53] Speaker 02:
arbitrary decision-making in the record?

[00:18:57] Speaker 04:
I'll say yes and no, Your Honor.

[00:19:00] Speaker 04:
The other drugs that were very recently approved were approved during this process and within the last year.

[00:19:07] Speaker 04:
So no, we did not include those studies.

[00:19:09] Speaker 04:
The FAA, though, provided a few of those studies for the record and insisted on including them.

[00:19:14] Speaker 02:
What about as to the FAA's rise since 2010?

[00:19:17] Speaker 04:
Yes, those are in the record.

[00:19:19] Speaker 04:
They're in the record.

[00:19:20] Speaker 04:
They've been attached to the many letters, the many requests and the applications and the request for reconsideration.

[00:19:26] Speaker 04:
They're discussed at length.

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For example, Dr. Dennison's 2022 report at the end of 2022 when he finished the second year of an SSRI protocol that or

[00:19:35] Speaker 04:
Pardon me, the second one year instance of going through the entire SSRI protocol.

[00:19:39] Speaker 04:
Dr. Dennison even explains, I've looked at and reviewed the specific studies that have been presented.

[00:19:45] Speaker 04:
And these are the same studies that the FAA is now citing in its denial, in particular about the long haul effect on truckers.

[00:19:52] Speaker 04:
And which comes to the conclusion, do a single high dosage at night and you don't have the sedative problem.

[00:19:58] Speaker 04:
Which again, Dr. Dennison saying, hey, this is what Mr. Solanz is doing.

[00:20:02] Speaker 04:
And there's not a sedative problem.

[00:20:04] Speaker 04:
And it hasn't been a sedative problem observed for the four clinical years now that we've been doing it.

[00:20:09] Speaker 04:
And really, Your Honors, this gets to the heart of the issue of what a special issuance is even about and why this is an abuse under the APA, an arbitrary capricious and contrary to law.

[00:20:20] Speaker 04:
The FAA has created a situation and it's argument that Rimron is just blacklisted period.

[00:20:25] Speaker 04:
That's fine with respect to a general aviation medical certificate.

[00:20:31] Speaker 04:
There can be qualifications.

[00:20:33] Speaker 04:
And if Remron is one of the prohibited medications, then the pilot does not qualify for the general certificate.

[00:20:39] Speaker 04:
That's fine.

[00:20:40] Speaker 04:
But that's why the FDA created a separate regulatory scheme and administration for special issuance, because that is the opportunity for pilots to demonstrate that they do not suffer under a medical condition that prevents them from getting the general, but also prevents them from doing the piloting, from being safe, from being effective.

[00:21:00] Speaker 04:
And that's why the FAA created its SSRI protocol for antidepressants.

[00:21:05] Speaker 04:
The FAA has determined that if you pass that protocol and you're on these seven slightly older antidepressants, then you've passed.

[00:21:14] Speaker 04:
You're eligible for a special issuance because that necessarily shows that it's in the public interest and there's not a public safety concern.

[00:21:21] Speaker 04:
Well, Mr. Salons has done that same protocol repeatedly for years, but because the FAA has, without any rulemaking, without any comment, and without any actual explanation or acknowledgement that this drug has ever been blacklisted until this appeal, has said, sorry, that's just not enough.

[00:21:40] Speaker 04:
just period, we have a bright line rule.

[00:21:43] Speaker 04:
And again, Your Honor, Judge Garcia, I know you think Irwin has some differences, but it does get to the point that when administering the FAA special issuance program, it can choose what evidence it looks at.

[00:21:58] Speaker 04:
It needs to look at the individualized medical evidence to assess whether that individualized medical evidence

[00:22:04] Speaker 04:
overcomes this presumption of some safety issue.

[00:22:09] Speaker 04:
And here we know it does, because we have four years of studies, not doctor shopping, but from the FAA, him psychiatrists and neuropsychologists.

[00:22:19] Speaker 02:
If we agreed on this argument, there's still the FAA said, sort of like a conditional denial based on these other diagnoses.

[00:22:29] Speaker 02:
We can't approve you now until you provide us with more information.

[00:22:33] Speaker 02:
One question is just, is it true that you've not provided that additional information because you don't think it should be necessary?

[00:22:41] Speaker 02:
Or has he provided the additional?

[00:22:43] Speaker 04:
Your honor, I would say that additional information had been provided many times to the FAA, but because we've been on a four-year hamster wheel where we submit something and then six months to nine months later we get a response, some of it may be outdated.

[00:22:57] Speaker 04:
So as part of a new special issuance and additional eye exam, that's fine.

[00:23:02] Speaker 04:
But I will say the other medical issues that the FAA sites and the air surgeon sites

[00:23:08] Speaker 04:
And they're clearly protectual.

[00:23:10] Speaker 04:
I mean, the AFIB issue, the atrial fibrillation, was resolved.

[00:23:13] Speaker 04:
A special issuance is in the record that was issued 20 years ago when that issue arose.

[00:23:18] Speaker 04:
Since then, it had been resolved, and Airman Salon's had proven the atrial fibrillation issue was resolved and had gotten regular, you know,

[00:23:27] Speaker 04:
the 100% general certificates for years.

[00:23:30] Speaker 04:
And yet it's dredged up now just to throw more mud on the wall and distract from the issue that the blacklist is Remron.

[00:23:38] Speaker 05:
When you go to the- I keep referring to the blacklist of Remron.

[00:23:41] Speaker 05:
Is it not permissible for the FDA, for the FDA, according slip, the FAA to not act as the FDA, for the FAA to have general

[00:23:55] Speaker 05:
disqualifications based on certain medications for a period of time, unless and until it determines that they don't ordinarily pose a risk, or is it your position that something that precludes a non-special issuance license

[00:24:19] Speaker 05:
must nonetheless be scrutinized by the FAA in terms of the individual pilot's experience on that medication.

[00:24:30] Speaker 05:
If there just isn't a role for a categorical hard stop, people on this medication aren't going to get special issuances.

[00:24:41] Speaker 05:
Or is your argument not that

[00:24:45] Speaker 04:
Well, your honor, I'd say it's more towards the latter, but it doesn't have to be that broad.

[00:24:48] Speaker 04:
And certainly this court need not issue an opinion that broad.

[00:24:52] Speaker 04:
The court here can focus on the fact that the FAA has approved several antidepressants and put in place a specific protocol because all of those antidepressants

[00:25:02] Speaker 04:
in the general population have an incidence of significant side effects that could affect aviation safety.

[00:25:08] Speaker 04:
That's why the FAA created its SSRI protocol.

[00:25:13] Speaker 04:
Here, the FAA has said, sorry, we're going to single out a different antidepressant, not tell pilots that it's singled out until after they've applied and gone through it.

[00:25:23] Speaker 04:
Ignore whether or not that other antidepressant has actual manifest the side effects we're concerned about, and instead just treat it differently.

[00:25:32] Speaker 05:
in the individual's case.

[00:25:33] Speaker 04:
As a categorical rule.

[00:25:34] Speaker 05:
Because they've said it manifests as a categorical rule, and there are some qualifiers on that with lower doses, taking it at night.

[00:25:43] Speaker 05:
You haven't mentioned the after two weeks on it, but there are various things in the record that say there may be people who take this who wouldn't suffer these effects.

[00:25:53] Speaker 05:
But my question was more a legal one, whether

[00:25:56] Speaker 05:
your position is inconsistent with a kind of general no-go on a medication, even if there may be individuals who would still be unaffected by the reasons for that no-go decision.

[00:26:18] Speaker 04:
Well, to that, Your Honor, I would say the special issuance regulation that the FAA created requires an individualized assessment.

[00:26:25] Speaker 04:
So if a pilot does not qualify for the general certificate due to the use of some medication that the FAA has not greenlisted, then the pilot's alternative is either give up their career or pursue a special issuance.

[00:26:40] Speaker 04:
And again, the point of a special issuance is not to say we're exempting or ignoring some particular safety hazard.

[00:26:46] Speaker 04:
It's to say, is there a reasonable way to minimize, mitigate, and even eliminate the risk that prevented a general certificate?

[00:26:57] Speaker 01:
We understand that, but isn't Judge Pillard's question, don't you have to answer her question directly?

[00:27:05] Speaker 04:
Pardon me, Your Honor.

[00:27:06] Speaker 01:
I don't understand that to be an answer to Judge Pillard's question.

[00:27:13] Speaker 01:
And that's what we're searching for here in terms of what your position is.

[00:27:17] Speaker 01:
You have repeated that an individualized assessment is required, and you define it one way, and the FAA has defined it to allow a blacklist.

[00:27:35] Speaker 04:
Yes, Your Honor, and I would say in the Irwin case two years ago, this court found that having a categorical rule and applying a categorical basis for denial to a request for special issuance was arbitrary, capricious, and contrary to the Administrative Procedures Act.

[00:27:49] Speaker 01:
So we are asking for that here.

[00:27:51] Speaker 01:
There's no point in our trying to re-argue that case.

[00:27:54] Speaker 01:
We're trying to understand what the legal principles there mean in light of the statutory and regulatory scheme before us.

[00:28:05] Speaker 01:
I thought you have to answer Judge Hillard's question, because your answer is, as I understand it, that the FAA could not interpret a special issuance to include blacklisted drugs, period.

[00:28:26] Speaker 05:
that it can't rely on that kind of categorical determination, that it has to scrutinize the basis for its own categorical no-go determination and to test whether it would apply to each individual seeking.

[00:28:44] Speaker 01:
And it's not only that, but as I understand it, it's that it has to do its own study of the particular drug, decide what it thinks,

[00:28:54] Speaker 01:
and whether any evidence presented to it persuades it to the contrary, and then do its own examination of your client, even though the FAA says very clearly that whether you are prescribed a certain drug is a decision for the airman's or air person's personal physician, not the FAA.

[00:29:26] Speaker 04:
Well, Your Honor, respectfully, I'm not quite sure that I would characterize our argument as that.

[00:29:31] Speaker 04:
I don't believe the FAA has to conduct its own medical studies.

[00:29:34] Speaker 04:
I think that's outside the scope of their expertise.

[00:29:36] Speaker 04:
And we're certainly not advocating this court create some sort of rule like that.

[00:29:41] Speaker 01:
But if the FAA finds that a drug, in its opinion, in light of the evidence before it, should be blacklisted, it cannot do that under your view

[00:29:55] Speaker 01:
what the special issuance requires.

[00:29:57] Speaker 01:
That's what we're trying to understand of your position.

[00:30:01] Speaker 04:
So our position is that a blacklist is impermissible to the extent the FAA is using it as basically a rubber stamp no, and refusing to look at any contrary medical evidence, and in particular medical evidence of safety, individualized, pardon me, individualized medical evidence of safety that the airman presents with respect to their application for the special issuance.

[00:30:25] Speaker 01:
Suppose the FAA and the surgeon wrote a pilot a letter that said,

[00:30:32] Speaker 01:
We have examined all of the studies going back 20 years.

[00:30:37] Speaker 01:
And the particular drug that's being used by this particular pilot has a 10% risk associated with it.

[00:30:51] Speaker 01:
And it lists the risk, including sleep apnea, constipation, nausea.

[00:31:00] Speaker 01:
Yeah, it just goes down the list.

[00:31:02] Speaker 01:
In your view, as a matter of law, would our decision in urban require granting a petition?

[00:31:16] Speaker 04:
So let's be clear.

[00:31:20] Speaker 04:
The petition is not asking this court to do something it's clearly uncomfortable with, and that would be substituting its own judgment as to whether this airman is safe.

[00:31:29] Speaker 04:
The petition is asking the court to order the FAA to actually consider the individualized medical evidence submitted.

[00:31:37] Speaker 04:
So, Your Honor, to your hypothetical, I think the issue is that the FAA can look at any studies it wants and create any blacklist it wants for a general certification.

[00:31:51] Speaker 04:
But the FAA chose to create in its regulations an alternative process, the special issuance process, which requires individualized assessment of the airman's particular safety and records.

[00:32:04] Speaker 04:
It's up to the airman to produce those records, to go through any of the required examinations, to submit the required information.

[00:32:11] Speaker 04:
Here, Mr. Solons has done all of that.

[00:32:14] Speaker 04:
So that really is the issue for this court.

[00:32:16] Speaker 04:
Can the FAA essentially merge

[00:32:19] Speaker 04:
its general certification requirements with the special issuance certification requirements so that the blacklist for a general medical certificate overrides and envelops really devours the special issuance process.

[00:32:33] Speaker 04:
And the answer has to be no, not just because the FAA wrote its regulations to create two separate divergent processes, but also for important public concerns, including public safety.

[00:32:46] Speaker 04:
Your Honors, early in the,

[00:32:48] Speaker 04:
In the brief, you know, we open with some extensive quotes from bipartisan aviation authority and the Transportation Committee of Congress such and those are in the record.

[00:32:58] Speaker 04:
The FAA had it to consider because

[00:33:02] Speaker 04:
Congress has noted that there's a mental health crisis with pilots, that pilots, because of the FAA secret blacklists, are afraid and are not seeking treatment, are instead self-mitigating or forgoing treatment altogether.

[00:33:17] Speaker 04:
They're afraid because the FAA is not doing its special issuance procedures and not following them, and instead is taking the same rubber no denial stamp that it used for the general

[00:33:28] Speaker 04:
medical certificate and applying it to the special issuance without actually looking at the airman's individualized medical records.

[00:33:35] Speaker 04:
And keep in mind, these are individualized medical processes that the FAA is asking the airman and sending back a denial letter saying, if you want a special consideration, go get these extra exams that show that this medical condition is not a concern.

[00:33:49] Speaker 04:
The airmen are doing that, including extensively Mr. Solanz for four years at their own expense, at their own time, while their own careers are interrupted,

[00:33:58] Speaker 04:
They're ultimately the FAA trained license.

[00:34:01] Speaker 04:
It's a very small pool of doctors and psychologists that the FAA allows to do these examinations in the HIMSS program.

[00:34:08] Speaker 04:
Those same FAA experts are saying it is not a problem that this particular pilot, it does not suffer any of the deleterious side effects that the FAA was concerned about.

[00:34:20] Speaker 04:
But the FAA still continues to say, sorry, we stamped your general request denied because of our blacklist.

[00:34:26] Speaker 04:
So now we're going to use that same blacklist to deny all special issuance despite inviting the pilot to continue the process and support medical information to the contrary.

[00:34:35] Speaker 04:
That, Your Honors, is what's arbitrary, capricious, and contrary to law, and that's what Your Honors have an opportunity to correct, to order the FAA to actually follow its special issuance process to look at Mr. Solanz's uncontroverted longitudinal medical records and determine whether that sedative effect is present or not.

[00:34:58] Speaker 04:
If Your Honors have no further questions.

[00:35:00] Speaker 05:
We'll hear from the agency.

[00:35:21] Speaker 05:
Mr. Carver, morning.

[00:35:22] Speaker 03:
Good morning.

[00:35:24] Speaker 03:
May it please the court, Ray Carver for the FAA.

[00:35:27] Speaker 03:
The federal air surgeon has the responsibility to ensure that pilots, and especially commercial pilots such as petitioner, are able to perform their duties without endangering public safety.

[00:35:38] Speaker 03:
In this case, the federal air surgeon made a reasoned determination based on the available medical and scientific information and clearly communicated those reasons, the reasons for denial to the petitioner.

[00:35:51] Speaker 03:
It's undisputed the petitioner is not medically qualified under the applicable medical standards.

[00:35:56] Speaker 03:
So instead, he challenges the FAA's exercise of its discretion in denying a request for an exemption from those medical standards.

[00:36:04] Speaker 03:
Courts have acknowledged that the review of an agency's exercise of discretion.

[00:36:09] Speaker 05:
I mean, there's tendencies on both sides in the briefing.

[00:36:12] Speaker 05:
But Mr. Solon says he's not seeing an exemption.

[00:36:16] Speaker 05:
He's seeking an individualized determination that he meets the standard.

[00:36:22] Speaker 05:
which is, I think, appreciably different.

[00:36:26] Speaker 05:
If an airman would want to prompt the FAA, I mean, in a lot of circumstances, you could petition for a rulemaking.

[00:36:36] Speaker 05:
Is there a way for someone to effectively petition for a rulemaking that the FAA would reconsider its categorical disqualification of people taking remeron?

[00:36:50] Speaker 03:
So I don't know that there's a specific way to prompt a rulemaking, but I would say in this case, the FA continues to review these policies.

[00:37:04] Speaker 03:
And as you can see from the federal air surgeon's letter, she notes that there were several

[00:37:12] Speaker 03:
several drugs that were approved in the last year that were added to the list.

[00:37:17] Speaker 03:
And also, you can see from the federal air surgeon's decision that she actually reviewed the new article that he had submitted with his application.

[00:37:29] Speaker 03:
She reviewed it.

[00:37:30] Speaker 03:
She weighed the evidence and came away with a conclusion regarding the impact of that article on her decision.

[00:37:38] Speaker 05:
Where are you pointing to?

[00:37:42] Speaker 03:
On page J 12 of the record.

[00:37:47] Speaker 03:
It is the Casper article that was provided by Petitioners Council and She's the federal air surgeon specifically states that she reviewed that article and

[00:38:02] Speaker 03:
notes that while, as the petitioner recognized, the FDA's information says that there's over half the people that take this medication experience somnolence or sedation.

[00:38:16] Speaker 03:
The federal surgeon does note that this Casper article does say that there are some studies that say that some people experience it or some studies see it at possibly a 14%.

[00:38:31] Speaker 03:
But she goes on to review that article and noted that that article simply provides theories.

[00:38:40] Speaker 03:
And as we stated in our brief,

[00:38:42] Speaker 03:
The Casper article highlights this as a paradox in the data and then goes on to speculate what this could possibly be and what the impact may be.

[00:38:54] Speaker 03:
This is far from conclusive evidence of a lesser risk.

[00:38:59] Speaker 02:
So are you saying we should read this?

[00:39:02] Speaker 02:
His argument has a lot of intuitive appeal.

[00:39:04] Speaker 02:
The FDA has this really high rate, but it's based on generic doses.

[00:39:08] Speaker 02:
This is specific to the type of dose I'm taking.

[00:39:11] Speaker 02:
And this study, which is based on pooled studies, shows just a 14% rate.

[00:39:18] Speaker 02:
Are you saying we should read this as that the air surgeon has determined that that study's report of 14.8% is unreliable or just that

[00:39:32] Speaker 02:
they didn't come up with a great explanation of why that's happening.

[00:39:36] Speaker 02:
But that sure seems to be the rate when you use that dose.

[00:39:40] Speaker 03:
So I would say that that article does not overcome the risk that's posed by the FDA's information.

[00:39:51] Speaker 03:
The FDA's 54%

[00:39:55] Speaker 03:
They acknowledge a 54%.

[00:39:57] Speaker 03:
That 14%, they acknowledge that this article states that that's been seen in several studies.

[00:40:06] Speaker 03:
However, it can't even explain where the reason for that reduction.

[00:40:11] Speaker 03:
I guess it's kind of a simple point.

[00:40:13] Speaker 02:
The FDA, as it comes to us, it just has a number, 54%.

[00:40:17] Speaker 02:
And he's saying, here's another number.

[00:40:19] Speaker 02:
And it's the number that's at the dosage that I take.

[00:40:22] Speaker 02:
We don't have any other information on the face of this.

[00:40:25] Speaker 02:
Other than.

[00:40:26] Speaker 02:
It sure seems like the 14% is the more relevant number than 54.

[00:40:32] Speaker 03:
So that that's where we rely on the the federal air surgeons review of these records to determine the impact of them.

[00:40:40] Speaker 05:
So in your view, the federal air surgeon would be empowered to, even though she didn't do it here, to say someone on Remeron, given enough medical records on that person, enough relevant medical tests conducted, that the air surgeon could, under a special assurance review, find the person qualified.

[00:41:05] Speaker 03:
Yes, if the federal air surgeon determined by looking at the available evidence that the risks associated with Remeron could be mitigated by something like the SSRI program, then certainly she could issue a

[00:41:24] Speaker 03:
a special insurance medical certificate.

[00:41:26] Speaker 05:
So it doesn't have to be moved to the conditional review or the conditional approval category that the SSRIs have been moved to in order or these other, I guess, I don't know if bupropion or duloxetine and venlafaxine.

[00:41:42] Speaker 05:
I don't know what category those are in, but they've been, so even with,

[00:41:51] Speaker 05:
the Remeron in the category that it's in now.

[00:41:55] Speaker 05:
That doesn't preclude special issuance, is that what you're saying?

[00:42:00] Speaker 05:
Without moving it into a different category?

[00:42:03] Speaker 03:
Correct.

[00:42:03] Speaker 03:
If there were additional information that were to come out to show that the risk is either, the risk is much less than what has been seen before, or that it could be mitigated

[00:42:18] Speaker 03:
sufficiently through the SSR program, the monitoring, whatever conditions might be placed on it, then certainly the federal air surgeon could rethink her stance on remeron.

[00:42:31] Speaker 03:
But that would be a categorical question.

[00:42:33] Speaker 03:
Right.

[00:42:33] Speaker 05:
That's a general question.

[00:42:34] Speaker 05:
What I'm asking, and sorry if I haven't been clear, what I'm asking is, are there drugs that are, practically speaking,

[00:42:42] Speaker 05:
a blacklist.

[00:42:45] Speaker 05:
You're basically special issuance or general issuance.

[00:42:48] Speaker 05:
If somebody's on certain drugs, you're going to think, that's too dangerous.

[00:42:54] Speaker 05:
And therefore, even within the context of special issuance, the air surgeon can say, no, I'm sorry.

[00:43:01] Speaker 05:
I see that.

[00:43:02] Speaker 05:
And I'm not really going to look at your experience on that drug just because

[00:43:06] Speaker 05:
We haven't gotten there with that.

[00:43:08] Speaker 05:
We're not yet comfortable with individual treating clinical opinion about your flight worthiness on that particular.

[00:43:18] Speaker 05:
Is there such a category or not?

[00:43:21] Speaker 03:
So I believe that the federal air surgeon can make that determination.

[00:43:25] Speaker 03:
I disagree with petitioners' assertion that there's a blacklist on medications.

[00:43:32] Speaker 05:
Well, it's a freighted term, but I guess I'm trying to come up with it.

[00:43:36] Speaker 05:
I'm calling it no go, that there might be certain medications where it's just like, that medication and flying a commercial airplane, we're not going to get into the details in anyone's case, because we just don't think we can do that.

[00:43:52] Speaker 05:
Is that a meaningful analytic category?

[00:43:55] Speaker 05:
Is it a practical matter that the FAA uses, or are you

[00:44:00] Speaker 03:
So certainly we see that with Remeron here where she, the federal surgeon has reviewed this and for years has been clear that the use of Remeron is not acceptable in terms of aviation safety due to the risk posed.

[00:44:16] Speaker 05:
But if she had, and this is the separate credit, and this is really a legal kind of policy schematic question, not a question about his record,

[00:44:26] Speaker 05:
If somebody came, you know, presented their records and their doctor said, yeah, this person's on Remeron, and he was very drowsy for the first two weeks, consistent with some of the studies, including the study the FAA relies on, but zero problems with sleep, happens to be a person who's never needed much sleep, blah, blah, blah, high level of alertness, in fact, extraordinary, off the charts level of alertness, and whatever else is in the record,

[00:44:56] Speaker 05:
If the air surgeon thought, yeah, I'm not going to change my general view on Remeron, but this person seems good to go.

[00:45:04] Speaker 05:
Could she without reassessing Remeron in general?

[00:45:10] Speaker 05:
We're at a special issuance license.

[00:45:12] Speaker 03:
Yes, there's nothing preventing the federal air surgeon from issuing a certificate or a special issuance in those terms.

[00:45:20] Speaker 03:
So if there is information available that, like I said, would

[00:45:26] Speaker 03:
mitigate that risk, then the federal air surgeon would be able to to grant a special issuance.

[00:45:32] Speaker 03:
And that's why I push back a little bit against the blacklist because this isn't a published, you know, this isn't a rulemaking of, you know, these certain medications

[00:45:43] Speaker 03:
are on a list and they're always a no-go.

[00:45:47] Speaker 03:
This is a decision that the federal air surgeon makes by reviewing the available information.

[00:45:52] Speaker 03:
And in this case, 54%, over half of people on this medication experience summits.

[00:45:58] Speaker 02:
But Justin, if you think about it this way, in terms of characterizing what position the air surgeon took in this order, am I right that the position is based on the available evidence

[00:46:11] Speaker 02:
I am going to maintain my categorical rule against allowing the use of Remeron.

[00:46:18] Speaker 03:
I believe that is the conclusion here.

[00:46:23] Speaker 02:
To make exceptional whatever other thing, which is as we stand, I'm staring at the list that is published on the FAA's website that says conditionally acceptable medications and has many listed, and then under a bright red box, unacceptable medications.

[00:46:40] Speaker 02:
And so this is the position that the air surgeon is taking.

[00:46:47] Speaker 02:
This is how I'm thinking about the case.

[00:46:49] Speaker 02:
There's been some confusion over whether the argument is that the FAA can just never have a categorical rule.

[00:46:58] Speaker 02:
about a drug.

[00:47:00] Speaker 02:
Let's just put that to the side.

[00:47:02] Speaker 02:
The question at a minimum has to be, has the FAA adequately explained why it has a categorical rule for this drug?

[00:47:10] Speaker 02:
And on that, I would love to hear your best arguments that the FAA gave a sufficient explanation.

[00:47:17] Speaker 02:
Because when I read this, it says, basically, there's a high risk.

[00:47:27] Speaker 02:
acknowledges this 14.8% number, and then it just asserts the one rationale is the approved drugs have, quote, much lower rates of semblance.

[00:47:37] Speaker 02:
It doesn't say how much lower.

[00:47:38] Speaker 02:
It doesn't say any of the sorts of things I might have expected it to say.

[00:47:44] Speaker 02:
Why is this enough of an explanation of a categorical rule?

[00:47:49] Speaker 03:
So, Your Honor, first, I go back to the standard of review here.

[00:47:55] Speaker 03:
The Supreme Court stated in State Farm that

[00:48:02] Speaker 03:
that the court must uphold a decision of less than ideal clarity if the agency's path may reasonably be discerned.

[00:48:09] Speaker 03:
In this case, you clearly have a path here where the federal air surgeon reviews the FDA prescribing information and says that over half of those people experience ambulance.

[00:48:21] Speaker 03:
And then it acknowledges the petitioner's article that says, okay, well, in some cases this may be lower

[00:48:29] Speaker 03:
but it doesn't provide a solid conclusion that provides theories.

[00:48:32] Speaker 05:
But the FAA itself relied on this Ramecker's study, and that study found that the set of effect is much alleviated by taking it

[00:48:46] Speaker 05:
at night, as Mr. Solance does.

[00:48:49] Speaker 05:
And also, I believe it's said that the sedative effects are really present during the first two weeks.

[00:48:58] Speaker 05:
And Mr. Solance has been, I mean, he had to wait, whatever, six months.

[00:49:01] Speaker 05:
He's been on this drug for a very long time, and his doctors are saying no sedative effects.

[00:49:07] Speaker 05:
So if the air surgeon were persuaded by that, it's your position she could have.

[00:49:12] Speaker 05:
notwithstanding the red box she could have granted for him, but that it was also within her prerogative, given the red box to say no.

[00:49:21] Speaker 03:
Yes, I believe that is true.

[00:49:22] Speaker 03:
If the federal air surgeon had reviewed that information and believed that the risk could be mitigated, it was within the federal air surgeon's ability to grant a special issuance there.

[00:49:34] Speaker 03:
However, on the flip side, the federal air surgeon also has the ability to look at certain medications and certain medical conditions for that matter and say that there are certain risks

[00:49:47] Speaker 03:
that are just simply too great for a pilot and especially a commercial pilot to be flying in aviation.

[00:49:54] Speaker 03:
Her primary responsibility is to that of aviation.

[00:49:59] Speaker 01:
And so- Okay, so let me follow up on that point.

[00:50:03] Speaker 01:
And this is on page 20 and 21, which is, what is it?

[00:50:10] Speaker 01:
JA 12 and 13.

[00:50:12] Speaker 01:
So the surgeon says she's looked at this paper

[00:50:17] Speaker 01:
All right, and that's the reference to the 14%.

[00:50:21] Speaker 01:
And the only reference I'm aware to the 14% is in this 1997 study by Casper, right?

[00:50:33] Speaker 01:
And she critiques it as theoretical, basically, and speculative.

[00:50:40] Speaker 01:
Then she says, I also note that a 1998 study

[00:50:46] Speaker 01:
by Rammeter's, O'Hanlon, et cetera, assessing the performance while driving and using this drug at a dose of 30 milligrams daily.

[00:51:00] Speaker 01:
This study reported poorer performance with keeping lanes positioned.

[00:51:08] Speaker 01:
All right, so she goes on and she says, given the available evidence,

[00:51:16] Speaker 01:
and my duty to ensure I'm unable.

[00:51:19] Speaker 01:
But then she goes on to point out these recent changes that have been made.

[00:51:24] Speaker 01:
But she goes on as to this particular case to have paragraphs about this particular pilot's other medical conditions.

[00:51:37] Speaker 01:
And you'll find that at JA 13 in both the paragraph starting second and the paragraph

[00:51:47] Speaker 01:
starting third.

[00:51:50] Speaker 01:
And then she has a conclusion about sleep apnea and other sleep conditions.

[00:51:57] Speaker 01:
So what I want to be clear about in terms of the adequacy of her explanation, it talks about this Remeron drug, what the evidence was before her.

[00:52:14] Speaker 01:
what studies she had and how she interpreted them, and then talk specifically about physical medical conditions of this particular pilot.

[00:52:29] Speaker 01:
Petitioners' Council has objected to the surgeon's reference to those other medical conditions.

[00:52:41] Speaker 01:
And I'm not clear

[00:52:44] Speaker 01:
other than earlier a statement in terms of saying, well, you never mentioned this before, but now you're mentioning these conditions now.

[00:52:56] Speaker 01:
Why this court should not consider that as part of the surgeon's complete explanation, dealing with the historical view of the drug, the study that pilot

[00:53:13] Speaker 01:
offered this Casper paper, and then looked at a study done a year later, and then talked about the particular physical medical conditions of this pilot.

[00:53:35] Speaker 01:
What I'm trying to understand from petitioners' argument is

[00:53:42] Speaker 01:
why it would be improper to consider the pilot's individual physical conditions, since he wants this individualized and says the surgeon must do it.

[00:54:00] Speaker 01:
And that's why I questioned him as this hypothetical, because I think it's close to saying that there must be a new

[00:54:13] Speaker 01:
evaluation by the surgeon of this particular drug.

[00:54:19] Speaker 01:
And he doesn't say she has to do the study, but she's looked at what he's given her, she's looked at what they had, and she's looked at him professionally.

[00:54:32] Speaker 01:
So if his view is that nevertheless, under Irwin, that is inadequate, other than filing a lawsuit,

[00:54:43] Speaker 01:
Is that the only remedy a pilot like the pilot before us has?

[00:54:52] Speaker 01:
Because your answer was, well, there's no way to file a petition for a rulemaking.

[00:54:59] Speaker 03:
So the remedy in that situation, again, to provide whatever additional information, additional studies that they would like to provide in that reconsideration process,

[00:55:11] Speaker 03:
And if the federal air surgeon determines that that doesn't mitigate the risk, they would be able to challenge it as they have.

[00:55:22] Speaker 03:
But again, the federal air surgeon is uniquely competent, is within the unique competence of the federal air surgeon to make these kind of determinations.

[00:55:34] Speaker 03:
She has to evaluate the scientific studies, the possible symptoms that could come.

[00:55:41] Speaker 01:
Okay, counsel, I'm going to interrupt because I just want to be clear about this.

[00:55:46] Speaker 01:
The FAA, are you taking the position that an individual pilot in seeking this special issuance would have to himself or herself

[00:56:04] Speaker 01:
fund a study to show that since these studies in the past century, a lot has happened.

[00:56:16] Speaker 01:
And these studies, I mean, those are very expensive.

[00:56:23] Speaker 01:
And who has the incentive to spend that money on this type of study?

[00:56:32] Speaker 01:
You go to Congress?

[00:56:33] Speaker 01:
and ask Congress for a special appropriation?

[00:56:36] Speaker 01:
I mean, council says all these congressmen are upset about this blacklisting, but do they give the FAA the funding to do these studies?

[00:56:46] Speaker 03:
So I'm certainly, I don't mean to insinuate that we would ask him to go out and fund some study, but the FAA has to rely on the studies that are completed in the community.

[00:56:59] Speaker 03:
And we look at the FDA's information, the studies that they rely on.

[00:57:03] Speaker 05:
And I don't think we're in any position to question that, but the studies that the FAA itself relies on, like

[00:57:12] Speaker 01:
My question, however, counsel, as you appreciate, was trying to understand this whole process here.

[00:57:19] Speaker 01:
Because we're raising a lot of questions that may be beyond what the court can decide, but to understand what's happening to an individual pilot who, as counsel Starr said, has done everything right.

[00:57:37] Speaker 05:
So, exactly.

[00:57:40] Speaker 05:
The studies that the FAA itself relies on, like the Ramaker study says, much less dominance if the medication is taken at night.

[00:57:51] Speaker 05:
The Wingen study that the FAA itself relies on says the drowsiness is mitigated after the first two weeks of taking it.

[00:58:05] Speaker 05:
So the question, and as you've noted that, well, there's a six month waiting period for someone who's gone on a new medication.

[00:58:14] Speaker 05:
And I guess the question that I understand Mr. Sorens to be asking is why, given that the air surgeon has the authority to decide that the risks, even of Remeron, don't disqualify me,

[00:58:33] Speaker 05:
How could my record possibly be more the poster child for the person who is entitled to that treatment, to that special issuance?

[00:58:44] Speaker 05:
And I don't think he's saying, you must give it to me, but he's saying, I don't see your explanation that's responsive to my particular case.

[00:58:59] Speaker 03:
federal air surgeon goes at length through his record and acknowledges on page 10 that his conditions are being are stable on treatment with normal performance and testing.

[00:59:16] Speaker 03:
But then she.

[00:59:18] Speaker 03:
On page 12, when she starts to talk about the medication, she states that that doesn't overcome the risks that are involved in that medication.

[00:59:28] Speaker 03:
And certainly petitioner disagrees with the judgment that was made at the end of the day.

[00:59:34] Speaker 03:
but it's the federal air surgeon's judgment based on the FDA information and those particular studies.

[00:59:41] Speaker 03:
Like the federal air surgeon said, I mean, certainly the Ramaker article does talk about some reduced risk, but it also states in there that there was a poor performance on driving on day 16.

[00:59:53] Speaker 03:
And so it's those things that, you know, that is

[00:59:58] Speaker 03:
the federal air surgeon's particular area of expertise is to review the methodology and the reasoning behind all of these articles.

[01:00:08] Speaker 03:
And she clearly did.

[01:00:10] Speaker 03:
She clearly read these articles.

[01:00:12] Speaker 03:
She evaluated them and put weight on them.

[01:00:15] Speaker 03:
And as the court required in State Farm, she made a rational connection between the facts that she found and the conclusions that were made.

[01:00:25] Speaker 03:
And Petitioner, once,

[01:00:28] Speaker 03:
He states that he's, you know, making this more of a procedural, we want to make sure there's a review, but he's clearly wanting to replace, wanting to substitute his judgment.

[01:00:40] Speaker 05:
He's asking that this court... To be fair, I mean, the Judge Rogers was pointing to these additional

[01:00:48] Speaker 05:
paragraphs, discussion of optic neuritis, which the treating doctors have said is resolved, is normal.

[01:00:59] Speaker 05:
The malignant melanoma, just completely wrong.

[01:01:06] Speaker 05:
And the neurosurgeon says,

[01:01:09] Speaker 05:
Your doctor said that the diagnosis is melanoma in situ, not malignant melanoma.

[01:01:15] Speaker 05:
And then goes on to say, malignant melanoma can pose a high risk, completely irrelevant, because that is not his diagnosis.

[01:01:23] Speaker 05:
And then sleep apnea, he's under the compliant treatment that's mentioned.

[01:01:29] Speaker 05:
So there's a feeling not unwarranted in reading this that it is hard to discern a reasonable path.

[01:01:39] Speaker 05:
like what really the decision is based on.

[01:01:41] Speaker 03:
So those, the final three there, the optic neuritis, the malignant melanoma and the sleep apnea are based on the federal air surgeons

[01:01:54] Speaker 03:
determination that she needed additional information.

[01:01:57] Speaker 03:
So that's the decision there.

[01:01:59] Speaker 03:
I mean, specifically with the malignant melanoma, she acknowledges that there's some conflict in the record.

[01:02:06] Speaker 03:
The record also states that he has malignant melanoma.

[01:02:09] Speaker 03:
And so when she asks for additional records, she's asking

[01:02:13] Speaker 03:
in part for all pathology specimens reported.

[01:02:19] Speaker 03:
So she's looking for the background, the complete medical file for that malignant melanoma.

[01:02:25] Speaker 03:
So she can look at it and determine, okay, was this melanoma situ?

[01:02:29] Speaker 03:
Was it malignant melanoma?

[01:02:31] Speaker 03:
Which was the correct diagnosis?

[01:02:34] Speaker 03:
And the same for optic neuritis.

[01:02:37] Speaker 03:
You know, she states in there about the risk of it developing or of it worsening and I believe.

[01:02:46] Speaker 03:
developing into MS.

[01:02:47] Speaker 03:
So she's asking for continued evaluations, continued review by his doctor.

[01:02:55] Speaker 03:
And so these are ongoing reports that we would normally ask for.

[01:02:59] Speaker 03:
And I think she makes clear, if he were to not be taking remeron, these are the things that the FAA would need in the future.

[01:03:09] Speaker 03:
And I think that's the federal air surgeon's attempt to try to give a holistic review and to be very

[01:03:16] Speaker 03:
open and honest and say look if you if you stop taking remeron we're still going to need some other things and so she's trying to be open and honest about what the fa's concerns are and what might be needed in the future uh notwithstanding the remeron that's just one last question about so i certainly appreciate the argument that

[01:03:38] Speaker 02:
Basically, she looks at the studies and concludes Remeron poses too high a risk of aviation safety.

[01:03:45] Speaker 02:
That's not the kind of thing that we have the position or role to question on its face.

[01:03:51] Speaker 02:
He then has an addendum to that.

[01:03:54] Speaker 02:
You have approved other drugs.

[01:03:56] Speaker 02:
Additionally,

[01:03:57] Speaker 02:
with significant rates of solvents.

[01:04:00] Speaker 02:
And it looks like the whole sum and substance of what could be a response to that argument is the sentence that says, those have a much lower risk of solvents.

[01:04:12] Speaker 02:
And why shouldn't we, at a minimum, be remanded to understand how much lower?

[01:04:19] Speaker 02:
Why is that significant?

[01:04:21] Speaker 02:
Why can you have case by case for those drugs, but not for this drug?

[01:04:25] Speaker 02:
Can you give sort of a direct response to that?

[01:04:28] Speaker 02:
Why is that sentence enough?

[01:04:30] Speaker 02:
Is there other material here?

[01:04:32] Speaker 03:
Yeah.

[01:04:32] Speaker 03:
So I don't think the FAA, I don't think the federal air surgeon was required to go point by point every single detail.

[01:04:40] Speaker 03:
The court said that an essay is not required for the disposition of every

[01:04:47] Speaker 03:
application.

[01:04:48] Speaker 03:
And in here, the federal air surgeon drafted a seven-page letter to try to address each one of his conditions, address the articles that he provided, and tried to give weight to each one of those.

[01:05:01] Speaker 03:
And specifically, she stated that they have a lower risk of somnolence.

[01:05:06] Speaker 03:
So I don't think that she's required to provide each and every detail about the level of

[01:05:15] Speaker 03:
the level of risk or somnolence in one medication versus somnolence on the other.

[01:05:22] Speaker 03:
The requirement is not that she prove every single point and respond to each one of the arguments.

[01:05:33] Speaker 03:
The standard of review here is to determine whether she is connected

[01:05:38] Speaker 03:
she's made a connection between those facts and the decisions made.

[01:05:42] Speaker 03:
And I think clearly here, she has done that.

[01:05:45] Speaker 03:
She's, petitioner may disagree with the conclusion that she's reached, but the federal air surgeon has clearly communicated the connection between those facts.

[01:06:03] Speaker 05:
So the, am I right in reading?

[01:06:04] Speaker 05:
I'm not sure how to read it, that the,

[01:06:10] Speaker 05:
The reference sleep apnea is referenced at the end of the letter, but it wasn't a basis for the denial here.

[01:06:24] Speaker 03:
My reading of it was that sleep apnea would require the ongoing information that's requested.

[01:06:30] Speaker 03:
So sleep apnea, the program does require that they provide ongoing data regarding their CPAP.

[01:06:38] Speaker 05:
It's not provided here, but it's not the basis here because the remeron is the basis.

[01:06:43] Speaker 03:
I believe the primary basis would be remeron.

[01:06:46] Speaker 05:
And so, too, with the punitive malignant melanoma, not the basis of this denial, but just saying if we were to go forward, if we were to clear the remeron hurdle, that we'd need these

[01:07:04] Speaker 05:
apology reports and other information.

[01:07:06] Speaker 03:
Correct.

[01:07:07] Speaker 03:
The federal surgeon saying, look, Remeron, we cannot issue you a special issuance, but also I can't make a decision at this point regarding these other conditions because we just don't have the information.

[01:07:24] Speaker 05:
And the optic neuritis being resolved, nonetheless, this denial letter says quarter to half of people with it end up with MS within 15 years.

[01:07:36] Speaker 05:
It doesn't seem like 15 years would matter, so long as it's two years away from mandatory retirement.

[01:07:43] Speaker 03:
Well, this retirement from the airlines, they would still be able to fly commercially, just not for an airline.

[01:07:57] Speaker 03:
And of course, they'd be able to fly privately as well in the airspace.

[01:08:02] Speaker 05:
Excuse me?

[01:08:02] Speaker 03:
They would also still be able to fly privately as well, which is still a concern.

[01:08:09] Speaker 05:
All right.

[01:08:11] Speaker 03:
Thank you.

[01:08:12] Speaker 05:
I think we have Mr. Nagy has.

[01:08:19] Speaker 05:
Nagy or?

[01:08:20] Speaker 04:
Nagy.

[01:08:21] Speaker 05:
Nagy has.

[01:08:23] Speaker 05:
Thanks, everybody.

[01:08:24] Speaker 04:
Thank you, Honors.

[01:08:26] Speaker 04:
Thank you, Honors.

[01:08:29] Speaker 04:
All right, so just a couple of points I want to address that were really raised before.

[01:08:33] Speaker 04:
One, there's a lot of talk about what exactly is the burden on the airman and what must they prove, in particular with respect to studies and such.

[01:08:41] Speaker 04:
But I want to make 100% clear that the issue here in this case

[01:08:46] Speaker 04:
if you can be summarized as succinctly as possible, is that with respect to Rimron, the federal air surgeon is relying wholly on generic studies and is not relying on the individual medical evidence from the airman, despite the air surgeon relying on individual medical evidence for all other antidepressants.

[01:09:05] Speaker 04:
And in particular, we see this in the air surgeon's denial.

[01:09:08] Speaker 04:
On page 12 of the joint appendix, one of the last sentences about Rimron says, this paper

[01:09:15] Speaker 04:
referring to the Casper article in study, does not refute the possibility of miretsapine still causing sedating effects.

[01:09:25] Speaker 04:
Let me clear, that's a telling admission because in the next paragraph, the air surgeon explains, well, the other antidepressants that we have a separate procedure for also have sedating effects.

[01:09:35] Speaker 04:
This is the arbitrary and capriciousness manifest.

[01:09:41] Speaker 04:
Now, with respect to other medical conditions, I want to be clear.

[01:09:46] Speaker 04:
I think our briefs do a pretty good job of explaining why those are pretextual.

[01:09:50] Speaker 04:
And in particular, though, it seems to bolster, to just to bolster the Remron sort of hide from it.

[01:09:59] Speaker 04:
In particular, with the CPAP.

[01:10:01] Speaker 05:
Just mean arbitrary and concoctious, inadequate.

[01:10:04] Speaker 04:
Excuse me?

[01:10:04] Speaker 05:
So you really, I mean, pretextual is usually a pretext for some kind of bias as opposed to

[01:10:11] Speaker 05:
just arbitrary, inadequate.

[01:10:14] Speaker 04:
Right, well, I would say the sort of bias is towards protecting the unpublished blacklist of medications and the ability of the air surgeon.

[01:10:21] Speaker 05:
I don't think it's enough.

[01:10:23] Speaker 05:
There's nothing that precludes the FAA from having a red box on certain medications.

[01:10:32] Speaker 05:
At least you haven't pointed to anything.

[01:10:34] Speaker 04:
Yes, well, I will point to that the FAA's attorney, been up here, explained that

[01:10:41] Speaker 04:
that with respect to having a sort of a bright line red box that the air surgeon has within their discretion under the regulations.

[01:10:50] Speaker 04:
And indeed, the special issuance regulation calls for the individualized assessment despite, to use your honor's words, a red box of something.

[01:10:57] Speaker 04:
So the failure to do that individualized assessment and instead just to rely on the red box with the special issuance would be the arbitrary and capricious.

[01:11:06] Speaker 04:
But I really wanted to get to, with respect to the CPAP,

[01:11:09] Speaker 04:
issue is just one example since that just came up as this potential, well, it would still be denied because other information needs to be presented.

[01:11:16] Speaker 04:
And two things, Your Honors, you've seen the copious record, the years of applications submitting this medical information and then not getting a denial for so long that then the next round of the denial says, well, hey, get off Remron, and if you do, we'll reconsider you, but by the way, resubmit everything you already submitted.

[01:11:34] Speaker 04:
With the CPAP, that's particularly telling because the CPAP condition, and I believe we have the site in our brief to the FAA's guidance on it, that's a standard condition of a special issuance.

[01:11:45] Speaker 04:
These aren't preconceptions.

[01:11:46] Speaker 04:
The only precondition is the airman's willingness to abide by the CPAP rules and recording requirements if the special issuance is given.

[01:11:54] Speaker 04:
Because that is the entire point of a special issuance, to craft something less than a general medical certificate that puts specific requirements on the airman.

[01:12:05] Speaker 04:
And sometimes, for a pilot with night blindness, that airman might not be allowed to fly at night.

[01:12:10] Speaker 04:
For a pilot that

[01:12:13] Speaker 04:
that has perhaps some physical disability and is unable to operate controls in a certain way, there's special issuances that are given that require a cockpit adaptation to allow operation of those controls.

[01:12:26] Speaker 04:
The point is the FAA has tremendous experience and capability to craft a special issuance that addresses the particular medical

[01:12:34] Speaker 04:
concerns that preclude a general certificate.

[01:12:38] Speaker 04:
And that's all we're asking for here is that the FAA take its time, actually do its consideration.

[01:12:43] Speaker 04:
And, you know, frankly, with these other conditions, the FAA proved, the air surgeon proved she's capable at looking at particular medical evidence.

[01:12:50] Speaker 04:
We think her cherry pick sites are wrong and explain them in our brief, but proved capable of looking at the specific pilot.

[01:12:56] Speaker 04:
Whereas with Remron here, there's no look at the specific pilot at all.

[01:13:00] Speaker 04:
And that's what this court explained is wrong in Irwin, where it said,

[01:13:03] Speaker 04:
The FAA is a repeat offender and must, well, Your Honor.

[01:13:08] Speaker 04:
Oh, may I finish the quote?

[01:13:10] Speaker 00:
Wrap up.

[01:13:10] Speaker 04:
Oh, yes.

[01:13:10] Speaker 04:
Well, and that was the last point.

[01:13:12] Speaker 04:
And that's the standard that this court explained in Irwin, that because the FAA is a repeat offender, they, quote, cannot simply declare its expertise and instead must exercise expertise and demonstrate sufficiently that it has done so.

[01:13:26] Speaker 04:
That's not what's happened here.

[01:13:28] Speaker 05:
Thank you, Your Honors.

[01:13:30] Speaker 05:
The case is submitted.