[00:00:00] Speaker 01:
The next case for argument is 23-1644S versus HHS.

[00:01:00] Speaker 01:
May I approach?

[00:01:02] Speaker 01:
Oh, yes, please.

[00:01:02] Speaker 01:
Thank you.

[00:01:03] Speaker 01:
Good morning.

[00:01:04] Speaker 01:
Good morning.

[00:01:05] Speaker 01:
Please proceed whenever you're ready.

[00:01:06] Speaker 04:
Thank you.

[00:01:12] Speaker 04:
May it please the court of the petitioners here to challenge the ruling denying the fact that a vaccine, HPV vaccine, caused an autonomic neuropathy.

[00:01:25] Speaker 04:
We are not here asking the court to reweigh the evidence.

[00:01:30] Speaker 04:
Our position is, the petitioner's position is, that the Chief Special Master, in rendering his decision, ignored evidence of record that directly contradicted his findings.

[00:01:43] Speaker 01:
He found- But when you say ignored, do you mean that he never referenced it in his opinion, or that you think he mistreated it?

[00:01:52] Speaker 04:
Yes.

[00:01:54] Speaker 04:
We mean that, but we also mean that even if the Chief Special Master references evidence,

[00:02:00] Speaker 04:
Referencing alone does not mean it was adequately considered.

[00:02:05] Speaker 04:
So for instance, he concludes that the petitioner, JS, had some kind of quote, some kind of mental disorder.

[00:02:15] Speaker 04:
He ignores the fact that six weeks after the onset of symptoms, JS had a complete psychiatric workup.

[00:02:26] Speaker 04:
And a neurologist said that her condition was more likely

[00:02:30] Speaker 04:
a rheumatologic condition.

[00:02:33] Speaker 02:
Do you agree that in order to succeed on this appeal, you need to win on both cognizable injury and also medical theory of causation?

[00:02:43] Speaker 04:
We understand that.

[00:02:44] Speaker 04:
And in our brief, we address the fact that the chief special master himself said that he did not do a full often analysis because he didn't need to because there was no cognizable injury.

[00:02:58] Speaker 04:
And then he also said, well, I've heard this expert in other cases.

[00:03:01] Speaker 04:
I've considered this issue.

[00:03:03] Speaker 04:
And based on that, I don't need a hearing.

[00:03:05] Speaker 04:
I don't need to consider anything.

[00:03:07] Speaker 01:
What's the standard of review?

[00:03:09] Speaker 04:
The standard of review is arbitrary, capricious, or contrary to law.

[00:03:14] Speaker 01:
However, how do we assess what seems to be the centerpiece of your argument, which is that he didn't adequately consider things?

[00:03:27] Speaker 01:
I mean, under an arbitrary and capricious standard, that's a pretty tough sell, right?

[00:03:33] Speaker 04:
We agree that we have to overcome that standard, the obstacle of that standard.

[00:03:40] Speaker 04:
In Palick versus HHS,

[00:03:43] Speaker 04:
This court said that the court has a duty to ensure that the special master has properly applied the Vaccine Act evidentiary standards, considered the relevant evidence of record, drawn plausible inferences, and articulated a rational basis for his decision.

[00:03:59] Speaker 01:
OK.

[00:03:59] Speaker 01:
Nobody's going to argue with that.

[00:04:01] Speaker 04:
No.

[00:04:01] Speaker 04:
But if you apply that, then we're saying he ignored evidence of record.

[00:04:07] Speaker 04:
He drew inferences.

[00:04:08] Speaker 04:
The chief special master diagnosed the petitioner

[00:04:13] Speaker 04:
with, quote, some kind of mental disorder based on emergency room preliminary assessments of anxiety.

[00:04:21] Speaker 04:
Anxiety can be a physiological cause or psychological.

[00:04:26] Speaker 04:
And the considered opinion of a neurologist or psychiatrist that this was not psychogenic.

[00:04:33] Speaker 02:
Can you point us to a particular part of the appendix where you say this chief special master did exactly what you just contended?

[00:04:39] Speaker 04:
Well, he refers to.

[00:04:41] Speaker 04:
a mental disorder, some other kind of mental disorder at Appendix 70.

[00:04:47] Speaker 04:
And that disorder is not defined in the medical record, conspicuously undefined.

[00:04:57] Speaker 04:
So that's where the special master said those words, some kind of mental disorder.

[00:05:04] Speaker 04:
Respectfully, that is not an appropriate finding by Chief Special Master

[00:05:10] Speaker 04:
when there is evidence of inappropriate sinus tachycardia based on objective testing, a Holter monitor testing, a Zio patch?

[00:05:19] Speaker 01:
But he dealt with that evidence, and he analyzed it and said it was insufficient or not probative.

[00:05:27] Speaker 01:
And are you saying that we would also have to conclude that his decision was arbitrary and capricious or not based on any plausible theory or evidence, right?

[00:05:41] Speaker 04:
Yes, the court would have to find that in order to.

[00:05:45] Speaker 01:
OK, well, I mean, it's a lengthy opinion.

[00:05:47] Speaker 01:
There are lots of details.

[00:05:48] Speaker 01:
It's a lot of medical terminology.

[00:05:50] Speaker 01:
But he went through the record, which is pretty lengthy.

[00:05:54] Speaker 01:
He went through all of the diagnosis or all of the observations made of the petitioner through the early years.

[00:06:02] Speaker 01:
And it's up to you to prove why that's wrong and why he erred.

[00:06:07] Speaker 01:
And it was arbitrary and capricious.

[00:06:10] Speaker 01:
I'm not getting it.

[00:06:11] Speaker 01:
I mean, what in the opinion?

[00:06:13] Speaker 01:
Are you pointing to something he did in the opinion, or are you pointing to his failure to do something that wasn't in the opinion?

[00:06:19] Speaker 04:
First of all, he summarily denied a hearing.

[00:06:23] Speaker 04:
We did not have a chance to, as Your Honor said, the volume of the record is huge.

[00:06:30] Speaker 04:
The issues in the record are multiple.

[00:06:33] Speaker 01:
And what is the standard for our deciding whether or not you're saying we should overturn it because he denied you a hearing?

[00:06:38] Speaker 01:
I don't recall seeing a case like that.

[00:06:40] Speaker 01:
So I don't know what we do with respect to the denial request for a hearing.

[00:06:44] Speaker 04:
The case is where a special master, even if he gives lip service to certain parts of the record or ignores other parts of the record,

[00:06:53] Speaker 04:
that it's an insufficient analysis that doesn't properly grapple with the facts of a case when a neurologist says, this is not psychogenic.

[00:07:04] Speaker 04:
A psychiatrist says, this is not psychogenic.

[00:07:07] Speaker 04:
But emergency room doctors say, anxiety.

[00:07:11] Speaker 04:
For the special master then to diagnose the petitioner with some kind of mental disorder that

[00:07:18] Speaker 04:
we submit is arbitrary and capricious.

[00:07:21] Speaker 04:
It's not a sufficient analysis of the evidentiary record.

[00:07:25] Speaker 02:
Can you show me where the special master diagnosed the petitioner with that?

[00:07:30] Speaker 04:
That is the same reference.

[00:07:31] Speaker 04:
He said it was a vague and amorphous diagnosis, a quote, some other kind of mental disorder.

[00:07:41] Speaker 02:
I'm not seeing it.

[00:07:42] Speaker 02:
Can you just turn to the page and point me to it?

[00:07:56] Speaker 01:
It's on the third paragraph, bottom of the third paragraph.

[00:08:00] Speaker 01:
Thank you, Your Honor.

[00:08:03] Speaker 01:
Instead, preponderant evidence strongly supports the conclusion that some other kind of mental disorder explains her symptoms.

[00:08:09] Speaker 01:
Well, there was a lot of, he talked early on about all of that evidence.

[00:08:14] Speaker 01:
I mean, is he not stating the record evidence fairly?

[00:08:19] Speaker 04:
We submit he's not.

[00:08:21] Speaker 04:
As a chief specialist, there's extraordinary discretion given to the special masters.

[00:08:26] Speaker 01:
Right.

[00:08:26] Speaker 01:
I mean, he did an extraordinarily detailed job.

[00:08:30] Speaker 01:
I mean, how many pages is this?

[00:08:32] Speaker 01:
I mean, it's tens and tens of pages.

[00:08:34] Speaker 01:
And he goes through all of the evidence, including a very detailed description of your doctor's, Dr. Steinman's view, and Dr. Lafayette or somebody else, Dr. Lefkowitz.

[00:08:45] Speaker 01:
There's an enormous detail provided for everything they said and his consideration of everything they said, and the basis for his rejecting it.

[00:08:55] Speaker 01:
Now, you may disagree as to the basis for his rejecting it, but we've got a pretty high standard of review, right?

[00:09:02] Speaker 04:
Yeah, there is a high standard of review.

[00:09:04] Speaker 04:
However, when a special master is given the extraordinary powers that he has, which is more than any trial judge anywhere,

[00:09:14] Speaker 04:
more than any jury.

[00:09:15] Speaker 04:
He is judge, jury, and he can marshal the evidence any way he wants, but he ignores essential components of the record that directly contradict his finding.

[00:09:26] Speaker 03:
That we submit.

[00:09:28] Speaker 03:
That's in every single one of these vaccine cases.

[00:09:31] Speaker 03:
There's evidence for the petitioners, and then the government puts in evidence from other doctors that the petitioner's claim isn't proven.

[00:09:39] Speaker 03:
And the special masters accept one version or they accept the other.

[00:09:44] Speaker 03:
And it's not arbitrary or capricious just because he didn't believe your experts and didn't believe the evidence provided by your side, is it?

[00:09:53] Speaker 03:
I would say- You keep saying ignored.

[00:09:55] Speaker 03:
Is it clear that he actually specifically failed to even consider evidence, or he just didn't agree with the evidence you put forward?

[00:10:04] Speaker 04:
No, I think it's the former.

[00:10:07] Speaker 03:
I submit it's the former.

[00:10:08] Speaker 03:
So you think that you put in evidence that this special master specifically refused to read?

[00:10:15] Speaker 03:
I can't say that.

[00:10:16] Speaker 03:
No, you can't because it's not on the record and he said he's considered the voluminous record and we've got to presume that he's done the job.

[00:10:23] Speaker 03:
You don't have a statement saying, I'm not reading this report because I don't think it should have been allowed.

[00:10:30] Speaker 03:
Of course not, but if you have extreme circumstances where it's- You have circumstances which is you think you have really good evidence, but there's other evidence suggesting that the injury is not attributable to the HPV vaccine.

[00:10:45] Speaker 03:
You think yours is this strong and that theirs is this strong, but the special master disagreed.

[00:10:51] Speaker 03:
When have we ever found something like that arbitrary and capricious?

[00:10:56] Speaker 04:
When the special master elevates

[00:11:00] Speaker 04:
of the standard that's required, standard proof of factual profit that's necessary.

[00:11:06] Speaker 04:
So if he did that here, he found that because there was no evidence of antibodies within 1 to 10 days of the vaccination, that then the evidence was inconsistent.

[00:11:17] Speaker 03:
When did he change the standard?

[00:11:18] Speaker 03:
I mean, this paragraph we were just talking about.

[00:11:20] Speaker 03:
He didn't change the standard.

[00:11:20] Speaker 03:
Well, that's what you just said.

[00:11:22] Speaker 03:
When you answered my question, you said he elevated the standard of proof.

[00:11:26] Speaker 03:
He applied the preponderance standard, right?

[00:11:28] Speaker 04:
Right, but he imposed a burden on the petitioner that the petitioner could never meet.

[00:11:34] Speaker 04:
No petitioner could ever meet it.

[00:11:36] Speaker 04:
That's improper.

[00:11:37] Speaker 04:
In other words, he can give lip service to the fact that he applied an arbitrary capricious standard.

[00:11:43] Speaker 04:
But if you impose an evidentiary burden on the petitioner that's so high, it could never be met.

[00:11:50] Speaker 02:
How do you know that such a high burden was imposed on the petitioner?

[00:11:53] Speaker 04:
Because the special master said that because

[00:11:58] Speaker 04:
There was no evidence of antibodies within 1 to 10 days.

[00:12:02] Speaker 04:
There's nothing in medicine, nothing in the record.

[00:12:04] Speaker 01:
Where is that in the record?

[00:12:05] Speaker 01:
That's not on page 70 that you cited, right?

[00:12:07] Speaker 04:
No, it's not on page 70.

[00:12:09] Speaker 04:
I don't know where it is right now.

[00:12:11] Speaker 04:
It's in the decision.

[00:12:13] Speaker 03:
But isn't your evidence of antibodies way too late?

[00:12:16] Speaker 03:
Isn't that what he was trying to say is?

[00:12:18] Speaker 03:
That you came forward with this antibody test, which he doesn't credit, because it's way too late in the game.

[00:12:25] Speaker 03:
There's nothing wrong with that, is it?

[00:12:28] Speaker 04:
We disagree with it, because the medical evidence is contrary to that.

[00:12:34] Speaker 04:
He didn't hold the hearing, so I couldn't hear why the expert would say, antibodies don't develop overnight.

[00:12:40] Speaker 04:
They don't develop within one to 10 days.

[00:12:42] Speaker 04:
That would be the evidence we proffered.

[00:12:44] Speaker 04:
We proffered that in the expert reports.

[00:12:46] Speaker 04:
That was your... Isn't your antibody test like two years later?

[00:12:49] Speaker 04:
Well, there were antibodies much sooner than that.

[00:12:52] Speaker 04:
Eventually, the petition was diagnosed with autoimmune condition, Stiffman syndrome.

[00:12:57] Speaker 04:
and undifferentiated connectivity.

[00:12:59] Speaker 01:
Well, I mean, this goes to the point of whether he ignored it or whether he didn't deal with it adequately.

[00:13:04] Speaker 01:
I just happened to find it on the Appendix 28.

[00:13:07] Speaker 01:
This is the Court of Claims review where he says, the special master clearly considered petitioners antibody testing

[00:13:14] Speaker 01:
between 2016 and 2020, but did not find it persuasive.

[00:13:19] Speaker 01:
And then she quotes the decision.

[00:13:20] Speaker 01:
I give little weight to the testing results petitioner obtained in 2020 almost five years after her vaccination and nearly four years after the case was filed, suggesting blah, blah, blah.

[00:13:31] Speaker 01:
So one, clearly consider it.

[00:13:33] Speaker 01:
And two, he gave a reason for rejecting it.

[00:13:37] Speaker 01:
Now, are you, on our standard of view, saying that we should reverse the decision because he was wrong in his evaluation of that information?

[00:13:50] Speaker 04:
No.

[00:13:50] Speaker 04:
Obviously, we couldn't reasonably ask the court to do that.

[00:13:55] Speaker 04:
We're maintaining our position that he ignored record evidence that was

[00:14:01] Speaker 04:
had to be dealt with and was totally contrary to his conclusions, specifically with respect to a mental disorder.

[00:14:08] Speaker 01:
OK.

[00:14:08] Speaker 01:
Why don't we hear from the government?

[00:14:09] Speaker 01:
Thank you.

[00:14:11] Speaker 01:
Good morning.

[00:14:26] Speaker 00:
May it please the court.

[00:14:26] Speaker 00:
My name is Zoe Wade, and I represent the Secretary of Health and Human Services.

[00:14:31] Speaker 00:
And today I'm asking you to affirm the Chief Special Master's decision denying entitlement because the Special Master's findings that the petitioner did not carry her burden to show that she suffered a vaccine injury.

[00:14:43] Speaker 00:
and did not provide a reliable causal theory are both supported by the evidence of record.

[00:14:47] Speaker 01:
Can you just turn to, because we don't need to go through a lot of the stuff that wasn't raised before with your friend, but his main argument or one of his main arguments seems to be the diagnosis that allegedly the special master made with respect to a mental disorder.

[00:15:03] Speaker 01:
So can you address that?

[00:15:05] Speaker 00:
I can address that.

[00:15:06] Speaker 00:
So I think that the

[00:15:08] Speaker 00:
The petitioner has characterized the special master's findings as being a diagnosis.

[00:15:13] Speaker 00:
I think he simply aggregated the various opinions that were replete throughout the records from various providers that she had some kind of psychological underpinnings to her symptom presentation, whether that was anxiety,

[00:15:28] Speaker 00:
panic attacks, she was also at one point considered psychosomatic seizures, et cetera, that there were a multitude of providers who associated her symptoms with something akin to anxiety or panic.

[00:15:41] Speaker 01:
So what do you understand your friend's concern and complaint with the special master having done that?

[00:15:47] Speaker 00:
I think that he is characterizing it as attaching a diagnosis, but I guess I don't agree with that characterization.

[00:15:56] Speaker 01:
Well, what leeway does a special master have in these circumstances?

[00:16:02] Speaker 01:
I don't read it as being his own diagnosis.

[00:16:05] Speaker 01:
But is he allowed or not allowed to go through the record and determine what the various diagnoses along the way by medical examiners who saw her were and to include or rely on that?

[00:16:18] Speaker 00:
Well, he is certainly required to consider the entire record.

[00:16:21] Speaker 00:
So he is required to consider all of that information.

[00:16:24] Speaker 00:
And what I think he found is that the number of instances where her symptoms were associated

[00:16:29] Speaker 00:
with her presenting, for example, immediately after her HPV vaccine the very next day.

[00:16:33] Speaker 00:
She presented to the emergency department, and she complained of having a panic attack.

[00:16:37] Speaker 00:
Her mother, who is a registered nurse, also said that's how she described what she observed.

[00:16:42] Speaker 00:
She reported being under stress, that she was moving away to college, and that she was discharged with a diagnosis of an anxiety reaction.

[00:16:51] Speaker 00:
And so all of her symptoms appear to be, at least in these initial days immediately following the vaccine,

[00:16:57] Speaker 00:
to be related to a panic attack, which is a mental diagnosis.

[00:17:01] Speaker 00:
It is a mental disorder, or it is at least

[00:17:04] Speaker 00:
A panic attack is a single incident, but panic disorder, anxiety disorder, whether they're- I'm sorry.

[00:17:12] Speaker 01:
I don't get enough of these cases.

[00:17:13] Speaker 01:
So I'm not up on all of the details of the legal requirements.

[00:17:16] Speaker 01:
Would the special master have been required to come up with an alternative diagnosis in order to prevail here?

[00:17:22] Speaker 01:
No.

[00:17:23] Speaker 00:
And I don't believe that he did.

[00:17:24] Speaker 00:
I guess he did in two respects.

[00:17:28] Speaker 00:
With respect to the diagnosis of POTS and inappropriate sinus tachycardia,

[00:17:33] Speaker 00:
He did make the comment that these credible instances of providers associating her symptoms with anxiety, panic disorder, psychosomatization, what have you, that that undercut a finding that she had sustained anything that would be considered or consistent with a vaccine injury.

[00:17:50] Speaker 00:
So on the one hand, he weighed that evidence, and it undermined the conclusion that the petitioner was seeking.

[00:17:57] Speaker 00:
But he did also then go on and say that if he was forced to find

[00:18:01] Speaker 00:
If the burden were to shift to the respondent, he would also find that there was sufficient evidence of an alternate cause for her symptoms.

[00:18:11] Speaker 02:
Council, opposing counsel repeatedly said that evidence was ignored and the like.

[00:18:16] Speaker 02:
Can you also respond to that?

[00:18:18] Speaker 00:
I don't think that's accurate.

[00:18:20] Speaker 00:
Obviously, I think I agree with the court's interpretation that the evidence, he thoroughly explained what the evidence was and then analyzed it.

[00:18:28] Speaker 00:
And so I just don't think that, I think that the dispute that the petitioner has raised is really with the weight that the Chief Special Master gave to that evidence, not with it having actually been ignored because

[00:18:39] Speaker 00:
You can see it's clearly referenced in his opinion.

[00:18:42] Speaker 01:
And he analyzed in some detail Dr. Lefkowitz's theories.

[00:18:47] Speaker 01:
Absolutely.

[00:18:48] Speaker 01:
And Dr. Steinman as well, I think.

[00:18:50] Speaker 00:
I would concur.

[00:18:52] Speaker 00:
And I think that it's important to note, in this case sort of started out as a POTS case, a postural orthostatic tachycardia syndrome.

[00:18:59] Speaker 00:
The chief special master went through her detailed history, and he noted that none of her treating providers ever diagnosed her with POTS.

[00:19:05] Speaker 00:
And it's notable, I think at least, that Dr. Lefkowitz, her treating cardiologist in 2017, indicated that he did not believe her symptoms were consistent with POTS.

[00:19:15] Speaker 00:
She was also, during one of her hospitalizations, she participated in a consultation with Dr. Nash, who was an infectious disease and pulmonary expert.

[00:19:25] Speaker 00:
He also indicated that her symptoms he did not believe were consistent with POTS or with significant autonomic dysfunction.

[00:19:32] Speaker 00:
And I think perhaps the most persuasive evidence in this particular case is that she was evaluated by experts in dysautonomia at the New York University Dysautonomia Center.

[00:19:44] Speaker 00:
She was seen and underwent the tilt table testing, all of the autonomic functioning testing.

[00:19:50] Speaker 00:
And those experts who were also provided with her medical history, this occurred approximately three months after her HPV vaccine, those experts did not diagnose POTS.

[00:19:59] Speaker 00:
They did not diagnose inappropriate sinus tachycardia.

[00:20:01] Speaker 00:
And they did not indicate that she had a dysfunctional autonomic system.

[00:20:06] Speaker 00:
Instead, they were receiving her, reviewing her medical history.

[00:20:11] Speaker 00:
And as it was reported by her,

[00:20:13] Speaker 00:
mother and herself indicated they counseled her that repeated panic attacks can result in reuptake of epinephrine and that can subsequently be stimulated by any sympathetic activation.

[00:20:27] Speaker 00:
So they referenced even exercise can kind of essentially panic attacks can beget more panic attacks was my understanding.

[00:20:34] Speaker 00:
And so their recommendation was for cognitive behavioral therapy

[00:20:39] Speaker 00:
for yoga or breathing exercises, and they also recommended she consider taking a beta blocker specifically to help her with stressful situations.

[00:20:47] Speaker 02:
Counsel, to affirm here, can we reach either the causation issue or the injury issue, i.e.

[00:20:52] Speaker 02:
we don't need to reach both?

[00:20:54] Speaker 00:
That is correct.

[00:20:54] Speaker 00:
That is correct.

[00:20:55] Speaker 00:
Either if this court upholds either the finding that the petitioner failed to demonstrate that she suffered a vaccine injury or failed to show a reliable causal theory, either of those would be fatal to

[00:21:06] Speaker 01:
And just one other quick point, which is your friend's concern about the failure to grant a hearing in this case.

[00:21:12] Speaker 01:
Do we have any cases that deal with how we evaluate that?

[00:21:16] Speaker 00:
We do.

[00:21:17] Speaker 00:
Vaccine Rule 8D, I believe, specifically authorizes a special master to decide a case without a hearing.

[00:21:23] Speaker 00:
But additionally, that issue was considered in, and I believe it's referenced in the

[00:21:29] Speaker 00:
On appendix 61, he discusses his decision not to hold a hearing in this case and cites to Kriesenbeck, which is his Federal Circuit opinion from 2020.

[00:21:39] Speaker 00:
So as long as the parties have a full and fair opportunity to present their case, it's within the court's discretion, the special master's discretion, whether to hold a hearing.

[00:21:50] Speaker 00:
Are there any further questions?

[00:21:52] Speaker 00:
Thank you.

[00:21:52] Speaker 00:
Thank you very much.

[00:21:57] Speaker 04:
are questions for me.

[00:21:58] Speaker 04:
I don't have anything else to add.

[00:21:59] Speaker 04:
I would just be repeating what I already said.

[00:22:02] Speaker 01:
Thank you.

[00:22:03] Speaker 01:
We thank both sides.

[00:22:04] Speaker 01:
The case is submitted.