[00:00:00] Speaker 04:
Our next case for argument is 23-1894, Henkel versus HHS.

[00:00:05] Speaker 04:
Mr. Kraus, please proceed when you're ready.

[00:00:53] Speaker 02:
May it please the court, Ed Krauss on behalf of Petitioners Appellants, Deidre and Alex Henkel as parents of VH.

[00:01:01] Speaker 02:
The special master found that petitioners met their Alton-Pronglund burden by providing a reliable theory explaining how the Flumis vaccine was capable of causing narcolepsy via molecular mimicry.

[00:01:13] Speaker 02:
This is the heavy lifting that petitioners must do to prevail in a non-table vaccine injury case.

[00:01:21] Speaker 02:
The special master then turned to all from prong two, where the task is to determine whether the facts of this case are consistent with that theory of causation based on the totality of petitioner's evidence.

[00:01:35] Speaker 02:
But rather than accepting petitioner's circumstantial evidence that clearly supported a logical sequence of cause and effect between the VH's vaccine and his narcolepsy, the special master required petitioners

[00:01:50] Speaker 02:
provide direct medical evidence that VH in fact underwent an autoimmune process.

[00:01:58] Speaker 02:
Evidence that the experts all agreed was unattainable without a dangerous and unnecessary brain biopsy.

[00:02:06] Speaker 01:
What's your view on what prong two does over prong one in this circumstance?

[00:02:14] Speaker 02:
Excellent question.

[00:02:16] Speaker 02:
Prong 1 is asking, can the vaccine cause the injury?

[00:02:20] Speaker 02:
Prong 2 asks, did the vaccine cause the injury under the facts and circumstances of this case?

[00:02:27] Speaker 02:
So the court in the Capizano case, this court, specifically held that the burden on petitioners under Alton Prong 2 is satisfied when petitioners can demonstrate a logical sequence of cause and effect

[00:02:44] Speaker 02:
between the vaccine and the injury.

[00:02:46] Speaker 02:
A logical sequence of cause and effect between the vaccine and the injury does not require a showing of specific pathological or laboratory findings confirming the VH experience in the autoimmune process.

[00:03:00] Speaker 02:
Caposano makes it clear that if you can show that the vaccine can cause the injury within an appropriate timeframe, PRONT2 is really just looking at, does it make sense?

[00:03:12] Speaker 00:
to conclude that the vaccine caused the injury here.

[00:03:24] Speaker 00:
And I mean, unless we find it's arbitrary and capricious.

[00:03:28] Speaker 00:
Yes.

[00:03:29] Speaker 00:
Tell me how, tell me how we find that arbitrary and capricious.

[00:03:32] Speaker 02:
Sure.

[00:03:32] Speaker 02:
Well, I would actually argue that it was legal error.

[00:03:34] Speaker 02:
I think it is also arbitrary and capricious, her findings, but it's legal error because she elevated the burden on petitioners.

[00:03:42] Speaker 02:
Petitioners presented circumstantial evidence.

[00:03:45] Speaker 02:
First, how this particular vaccine can cause narcolepsy.

[00:03:50] Speaker 02:
Second,

[00:03:51] Speaker 02:
that VH was a child who was genetically predisposed to developing narcolepsy.

[00:03:56] Speaker 02:
Third, that he was healthy when he received the flu vaccine.

[00:04:01] Speaker 02:
And then fourth, that after he received the flu vaccine, he developed narcolepsy.

[00:04:06] Speaker 00:
But it was the second time he received the flu vaccine, the first time there was no impact, correct?

[00:04:11] Speaker 02:
Okay.

[00:04:11] Speaker 02:
And yes, that is

[00:04:15] Speaker 02:
That statement is correct, but it's also not relevant at all to the theory in this case.

[00:04:20] Speaker 02:
And that actually is important because that misunderstanding misinformed the special master's decision on prong three.

[00:04:32] Speaker 02:
as well as on prong two.

[00:04:33] Speaker 01:
Before we get to prong three, can I ask you the question I'm afraid to ask after what went down in the prior case?

[00:04:39] Speaker 01:
But my understanding, there are three prongs, and you have to prevail on each of these prongs in order to win the case.

[00:04:46] Speaker 01:
That is correct.

[00:04:47] Speaker 01:
Petitioners.

[00:04:47] Speaker 01:
So turn to three, because that seems a little more straightforward.

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

[00:04:53] Speaker 01:
Yeah.

[00:04:54] Speaker 01:
If that's OK with Judge Mazzotti.

[00:04:57] Speaker 00:
No, please.

[00:04:58] Speaker 02:
Sure.

[00:04:58] Speaker 02:
I mean, prong three.

[00:05:01] Speaker 02:
I think you're correct in terms of the standard that would apply on prong three.

[00:05:07] Speaker 02:
It really is an argument that the... So it was undisputed there.

[00:05:11] Speaker 01:
You said four to six weeks, and the special master says no.

[00:05:15] Speaker 01:
The evidence doesn't support it.

[00:05:16] Speaker 01:
It supports incurring this at a later time.

[00:05:21] Speaker 02:
And the special master's decision was erroneous.

[00:05:24] Speaker 02:
It ignored... The standard of review that we have.

[00:05:27] Speaker 02:
It was not based on reasonable inferences from the medical literature the petitioner provided.

[00:05:34] Speaker 02:
And it also misunderstood Dr. Steinman's testimony about a recall response.

[00:05:39] Speaker 02:
So two things.

[00:05:42] Speaker 02:
One, the literature that she looked at that petitioners provided relating to when narcolepsy occurs after a flu vaccine was looking at diagnosis.

[00:05:56] Speaker 02:
So she said six months is the appropriate time frame.

[00:06:00] Speaker 02:
But that's not the issue on prong three.

[00:06:04] Speaker 02:
The issue on prong three is, when did the symptoms, initial symptoms that ultimately, as they got worse, led to a diagnosis of narcolepsy occur?

[00:06:15] Speaker 02:
Those initial symptoms occurred four to six weeks after the vaccination.

[00:06:20] Speaker 02:
And those symptoms were fatigue.

[00:06:25] Speaker 02:
At that point, at four to six weeks, his doctors didn't know.

[00:06:28] Speaker 01:
But we were under a very deferential standard of review.

[00:06:31] Speaker 01:
And I think the government pushes back on your point.

[00:06:34] Speaker 01:
Yes.

[00:06:36] Speaker 01:
And all the special master found was that the expert failed to explain how a recall response would impact the timing of the disease onset here.

[00:06:47] Speaker 01:
And I don't think that's a sort of

[00:06:50] Speaker 01:
We want something that we can review and overturn or reject.

[00:06:56] Speaker 02:
Respectfully, Your Honor.

[00:06:57] Speaker 02:
Why?

[00:06:57] Speaker 02:
Petitioner presented uncontroverted evidence that four to six weeks is the appropriate time frame for an autoimmune condition to occur via molecular mimicry following a vaccine.

[00:07:10] Speaker 02:
So the general molecular mimicry theory is utterly consistent with the four to six week time frame.

[00:07:18] Speaker 02:
Second,

[00:07:19] Speaker 01:
But are we talking about the recall response?

[00:07:22] Speaker 01:
His opinion that this time frame was appropriate for the recall response.

[00:07:27] Speaker 01:
That's what the special master was talking about.

[00:07:29] Speaker 02:
I'm sorry to interrupt, Your Honor.

[00:07:31] Speaker 02:
The special master misunderstood the testimony about a recall response.

[00:07:37] Speaker 02:
She thought Dr. Steinman was referring to something called a re-challenge.

[00:07:42] Speaker 02:
She asked him questions about it, but he didn't have a reaction.

[00:07:45] Speaker 02:
after the flu mist when you received it the first time.

[00:07:48] Speaker 02:
That has nothing to do with a recall response.

[00:07:52] Speaker 02:
A recall response, it's definitional.

[00:07:55] Speaker 02:
It applies if somebody receives a vaccine and then subsequently gets the same vaccine.

[00:08:01] Speaker 02:
Whatever the response is, it's likely to be considered a recall response.

[00:08:06] Speaker 02:
It didn't change the timing.

[00:08:09] Speaker 00:
What I'm struggling with is that the special master did all this and considered all this evidence and of course with my district judge hat I'll put back on for a second is I try cases all the time where all the evidence is circumstantial and the jury decides

[00:08:27] Speaker 00:
whether it meets the claim or not, or draws whatever reasonable emphasis from that.

[00:08:31] Speaker 00:
And then I affirm the jury verdict.

[00:08:32] Speaker 00:
And in those cases, they can go either way, and I have to affirm the jury verdict.

[00:08:36] Speaker 00:
So the special master did that.

[00:08:38] Speaker 00:
And with our differential review, I'm struggling how we get past that.

[00:08:42] Speaker 02:
Well, respondents experts didn't even contest the four to six week timing as being inappropriate here.

[00:08:50] Speaker 02:
It was just a non

[00:08:52] Speaker 02:
It was sort of a non-contested issue because four to six weeks for the onset of symptoms following a vaccine is consistent with everything we understand about the immune response.

[00:09:04] Speaker 02:
The special master simply misunderstood the literature because she looked at a sentence that refers to the onset of narcolepsy six months after vaccination, but that's the diagnosis.

[00:09:19] Speaker 02:
And the point is, prong three is drilling down and asking, is four to six weeks, under a preponderance of the evidence standard, consistent with what you would expect given the theory of causation?

[00:09:34] Speaker 02:
Which here, molecular mimicry.

[00:09:38] Speaker 02:
So I do think that under a fair reading of the evidence, the special master's finding on prong three is clearly erroneous.

[00:09:50] Speaker 02:
And I would like to get back to prong two for a second, because I do think it relates to prong three as well.

[00:10:00] Speaker 02:
In Capizano, the court, as I mentioned, specifically held that that prong two standard can petitioners demonstrate a logical sequence of cause and effect.

[00:10:12] Speaker 04:
And in order to- No, prong one is-

[00:10:18] Speaker 04:
the possibility of causation.

[00:10:21] Speaker 04:
Prong two is really more the probability of causation.

[00:10:26] Speaker 04:
Prong two is, did it happen in this case?

[00:10:28] Speaker 04:
Did this person's injury, was it caused by the vaccine?

[00:10:34] Speaker 04:
And you have to prove that by proponents of the evidence.

[00:10:36] Speaker 04:
So how did you do that?

[00:10:38] Speaker 04:
What is your evidence to prove not just that there is a medical theory by which it could have resulted?

[00:10:43] Speaker 04:
Because here's the thing.

[00:10:45] Speaker 04:
Keep in mind that it's possible that a particular

[00:10:48] Speaker 04:
thing like narcolepsy, maybe could be caused, you know, one in a thousand times by a flu vaccine or something, right?

[00:10:56] Speaker 04:
But that means 999 times it's not.

[00:10:58] Speaker 04:
It's caused by something else.

[00:10:59] Speaker 04:
So it's, it's not, it's certainly, the fact that you would satisfy prong one does not mean every one of the cases that

[00:11:06] Speaker 04:
where someone has narcolepsy, they were actually caused by the flu vaccine, right?

[00:11:09] Speaker 04:
We agree on that.

[00:11:10] Speaker 01:
Absolutely.

[00:11:11] Speaker 04:
So prong two is where you have to prove, OK, now in this case, you did it.

[00:11:15] Speaker 04:
You overcame a huge hurdle.

[00:11:17] Speaker 04:
You established that it's possible.

[00:11:19] Speaker 04:
And you've got a medical theory of causation that was found to be accepted.

[00:11:23] Speaker 04:
And so on prong two, what is your precise facts?

[00:11:27] Speaker 04:
How did you prove it more likely than not that the narcolepsy was caused by the flu vaccine in this case?

[00:11:37] Speaker 02:
First, and I know that you're aware of this, the fact that petitioners showed that the vaccine can cause narcolepsy is part of the PRON2 showing.

[00:11:48] Speaker 02:
It's not sufficient, but it's part of that showing.

[00:11:50] Speaker 02:
But second of all, petitioners showed that VH was genetically susceptible to developing narcolepsy.

[00:11:57] Speaker 02:
VH was healthy.

[00:11:58] Speaker 02:
He received the flu vaccine.

[00:12:00] Speaker 02:
Four to six weeks later, he had the onset of symptoms of narcolepsy in a manner and time frame that's consistent with Petitioner's theory of causation.

[00:12:10] Speaker 02:
Capizano tells us that if you meet prong one and you meet prong three, which I understand is disputed, the inquiry under prong two is, are there facts here that are inconsistent?

[00:12:23] Speaker 02:
And there are no facts that are inconsistent with

[00:12:27] Speaker 02:
the theory the petition was presented under prong one.

[00:12:31] Speaker 02:
And Capizano has a very important quote that it says that the fact that there's a possibility that the injury coincidentally appeared after the vaccine doesn't prevent a finding that more likely than not the vaccine caused it.

[00:12:53] Speaker 02:
Yet that's exactly what happened here.

[00:12:55] Speaker 01:
But Capizzano, I think the section you're referring to says that even if you find one in three, a claimant can't satisfy the first and third without satisfying the second prong, where medical records and medical opinions do not suggest that the vaccine caused the injury.

[00:13:11] Speaker 02:
But that was not the case here.

[00:13:12] Speaker 02:
There was nothing in the medical records that didn't suggest that.

[00:13:16] Speaker 02:
And Petitioner also provided supporting opinions from treating neurologists.

[00:13:23] Speaker 02:
that the court refused to credit.

[00:13:25] Speaker 02:
One of his experts, or sorry, treating doctors, Dr. Pfeffer, specifically talked about the concern that this child was injured or that this child's narcolepsy occurred as a consequence of the vaccine.

[00:13:42] Speaker 02:
The special master refused to credit that because she said that that opinion didn't specifically help her determine that the biological process

[00:13:52] Speaker 02:
occurred in VH.

[00:13:54] Speaker 02:
That's not the standard.

[00:13:55] Speaker 02:
The standard is logical sequence of cause and effect.

[00:13:58] Speaker 02:
And ALTIN, if it stands for anything, it stands for the fact that circumstantial evidence is sufficient for petitioners to meet their burden of causation.

[00:14:08] Speaker 02:
I mean, in the ALTIN case, the court was

[00:14:14] Speaker 02:
looking at the burden that was on petitioners prior to Alton.

[00:14:19] Speaker 04:
I think that you should save some time for rebuttal, because you won't have any otherwise.

[00:14:22] Speaker 04:
So let's go on to Ms.

[00:14:26] Speaker 04:
Yark.

[00:14:50] Speaker 05:
Good morning and may it please the court.

[00:14:52] Speaker 05:
My name is Madeline Yark.

[00:14:54] Speaker 00:
Sorry.

[00:14:55] Speaker 00:
No, if you have a question you're under... No, there are two issues that kind of bother me and so I'll just tell you upfront.

[00:15:02] Speaker 00:
One is they found prong one versus all these cases where they don't even get to prong one.

[00:15:07] Speaker 00:
But the Special Master found prong one.

[00:15:09] Speaker 00:
And then second, the issue that bothers me is that the only way to get causation evidence is a brain biopsy, which you cannot do in a live person.

[00:15:18] Speaker 00:
So how can they, so the problem is, how can they ever get past that other than a circumstantial case?

[00:15:25] Speaker 05:
Your Honor, I'd like to respond to those in part.

[00:15:27] Speaker 05:
First, the question about prong one.

[00:15:30] Speaker 05:
This court in Boatman has specifically said that there's a preponderance evidence requirement on each prong.

[00:15:35] Speaker 05:
So the fact that petitioners did meet their burden on prong one does not mean that they meet their burden on prongs two or three.

[00:15:41] Speaker 05:
And while some of the theory that comes from prong one can translate over to two and three, it does not automatically mean that they meet prongs two and three.

[00:15:50] Speaker 05:
And the special master in this case found that they didn't.

[00:15:53] Speaker 05:
She found that with regards to prong three that Dr. Steinman, the basis for his theory on prong three was simply adductive reasoning that it was the Zipsa Dixit that he said because the child's onset occurred four to six weeks after the vaccination, that that's the appropriate time frame in this case.

[00:16:10] Speaker 00:
And then, Your Honor, can you remind me of your... The second part was the bother me is the issue that the only way to prove this case to get past Prong One would be a brain biopsy.

[00:16:21] Speaker 00:
So that's troubling because there's no other way than other than the way they try to do it, isn't it, to prove it.

[00:16:28] Speaker 05:
Respectfully, Your Honor, that's not true.

[00:16:30] Speaker 05:
There was testimony from one of our experts, Dr. McGinnity, that he suggested that, and I can give you the page citation, that's appendix 33, that if there was no autoimmune attack going on here, that we would not just expect narcolepsy, we would expect other neurological issues.

[00:16:49] Speaker 05:
And there weren't any tests done or any biomarkers found that would indicate that this child's course of narcolepsy was

[00:16:58] Speaker 05:
that this child's course of narcolepsy was quickened, as Dr. Steinman would suggest, or that it was different from any other course of narcolepsy.

[00:17:05] Speaker 04:
Is that what they have to prove, that their course of narcolepsy was somehow different or quickened from other courses of narcolepsy?

[00:17:13] Speaker 05:
Per Dr. Steinman's theory, yes.

[00:17:14] Speaker 05:
That was his theory under the recall.

[00:17:16] Speaker 05:
And when we have a moment like to address petitioners' concerns about the court's confusion with respect to recall and re-challenge,

[00:17:24] Speaker 04:
I'm just trying to understand what they have to prove under ALT and PROMP2 in terms of causation.

[00:17:29] Speaker 04:
What did they need to show that they didn't?

[00:17:32] Speaker 04:
Because surely it can't just be that if one of those doctors said, did cause rather than may cause, that would have carried water.

[00:17:39] Speaker 04:
Because respectfully, that's just a matter of language.

[00:17:46] Speaker 04:
One of those doctors saying, did cause, some doctors might have been willing to say that

[00:17:53] Speaker 04:
regardless of any additional information.

[00:17:55] Speaker 04:
I mean, that can't be what it is.

[00:17:57] Speaker 04:
It can't be that.

[00:17:58] Speaker 05:
It's not.

[00:17:58] Speaker 05:
I think, Your Honor, it's the combination of the two.

[00:18:01] Speaker 05:
It's the treater statements as well as... The what?

[00:18:03] Speaker 05:
The treater statements, as well as the lack of biomarkers or testing in this case.

[00:18:08] Speaker 04:
Well, the treater statements, I don't see how they help the government at all.

[00:18:12] Speaker 04:
Well, it's not... You have all of these doctors looking at this narcolepsy, and their first instinct is it may have been caused by this vaccine.

[00:18:19] Speaker 04:
May have been caused by the vaccine.

[00:18:21] Speaker 04:
That feels actually like it helps them, not you, because if their first instinct is that it might've been caused by the vaccine, even if they don't go so far as to say it was caused by the vaccine, the implication there is that that's their leading theory on what caused it, even if they didn't say it is what caused it.

[00:18:39] Speaker 05:
Well, the special master found significant that the, Dr. Feffer, that the sleep addition specialist originally found that it was idiopathic hypersomnia and that by time she did make a diagnosis of narcolepsy, as your honor said, she said may or may not have.

[00:18:52] Speaker 04:
Just to be clear, do you know anything about narcolepsy?

[00:18:54] Speaker 04:
I mean, I don't know much about it.

[00:18:56] Speaker 04:
But I imagine that when somebody has trouble sleeping, the very first appointment you go to, they don't say, ah, you have narcolepsy.

[00:19:04] Speaker 04:
It feels like it might be one of those things that has to persist over time.

[00:19:08] Speaker 04:
You know, I don't know.

[00:19:09] Speaker 04:
I'm not a doctor, but maybe you know.

[00:19:12] Speaker 04:
I don't know.

[00:19:12] Speaker 04:
It seems, I feel like if I went in and said, I'm having trouble sleeping, my kid's not, or my kid's not sleeping, I feel like the first thing they might say is, you probably have some insomnia.

[00:19:20] Speaker 04:
And then when it persists, they might say, oh, maybe now it's actually something more serious.

[00:19:24] Speaker 04:
Is that a crazy way to think about this?

[00:19:26] Speaker 05:
I don't think that's a crazy way to think of it, Your Honor.

[00:19:29] Speaker 05:
As far as I'm concerned, narcolepsy is often treated as a diagnosis in which other diagnoses need to be excluded, as you suggested.

[00:19:37] Speaker 05:
But it's the may or may not have that, in addition to Dr. Pfeffer's statements about the H1N1 that the Special Master reasonably concluded

[00:19:46] Speaker 05:
didn't support Petitioner's theory.

[00:19:48] Speaker 01:
Can I interrupt for a minute?

[00:19:49] Speaker 01:
What bothered me and what I had trouble on how to take what the government was saying is I thought most, so tell me if I'm wrong, I read most of your argument on Prague 2 as being nod, nod, wink, wink.

[00:20:04] Speaker 01:
We think he got it wrong on prong one.

[00:20:06] Speaker 03:
He is never agreeing to nod, nod, wink, wink.

[00:20:08] Speaker 03:
When you say, tell me if I get it wrong, and you start with nod, nod, wink, wink.

[00:20:13] Speaker 03:
She'd have to say, that's what's in our brief.

[00:20:16] Speaker 01:
I read your brief as really not appealing the fighting of prong one, but describing your argument on prong two, kind of tagging it on to prong one.

[00:20:29] Speaker 01:
Well, prong one wasn't really strong,

[00:20:32] Speaker 01:
and the special master shouldn't have or didn't do this.

[00:20:36] Speaker 01:
Am I misreading it, or does the government disagree with the finding on one?

[00:20:41] Speaker 01:
And do they not use that disagreement on prong one to argue prong two?

[00:20:49] Speaker 05:
I understand your confusion, Your Honor.

[00:20:52] Speaker 05:
It's my understanding that Respondent offered its criticisms on prong one because petitioners

[00:20:58] Speaker 05:
tried to suggest that prong one covered the deficiencies on prong two, so we felt compelled to respond to the specifics on prong one.

[00:21:06] Speaker 05:
Respondent did not file a motion for review because the special master did find that petitioners did not meet their burden on prongs two and three, so there was in effect no reason for us to appeal her findings on prong one.

[00:21:19] Speaker 05:
And while we disagree that the flu mist vaccine does cause or can cause, excuse me,

[00:21:24] Speaker 05:
Narcolepsy, we don't find that the Special Master committed error in her analysis.

[00:21:34] Speaker 01:
Can we move you to prong three?

[00:21:36] Speaker 01:
Yes, ma'am.

[00:21:36] Speaker 01:
Which I find, as I said earlier, the easiest to get through.

[00:21:39] Speaker 01:
So you heard your friend's response to, and I think it was predominantly the special master misunderstood the expert's testimony with regard to recall, and it wasn't recall, and so forth.

[00:21:51] Speaker 01:
So can you respond to that?

[00:21:53] Speaker 05:
Yes, Your Honor.

[00:21:54] Speaker 05:
I'd like to direct the court's attention to a portion of the hearing testimony.

[00:22:02] Speaker 05:
This is at Appendix 741, Your Honor.

[00:22:06] Speaker 05:
This is sort of the beginning of the discussion.

[00:22:08] Speaker 05:
741?

[00:22:09] Speaker 05:
That's correct, Your Honor.

[00:22:11] Speaker 05:
I'll give you all a moment.

[00:22:16] Speaker 01:
It starts by talking about COVID, which is not a good sign.

[00:22:27] Speaker 05:
No, Your Honor, I would agree.

[00:22:30] Speaker 05:
So at the bottom of that page, the argument I believe the petitioner is making is from where I believe that the Special Master misspoke.

[00:22:39] Speaker 05:
She said in that last sentence at line 23, evidence of re-challenge.

[00:22:44] Speaker 05:
But what I think is significant is if you track that conversation between Special Master Sanders and

[00:22:49] Speaker 05:
Dr. Steinman, it's clear that he didn't correct her and that she understood that it was recall.

[00:22:55] Speaker 05:
She regurgitates back to him.

[00:22:57] Speaker 01:
So this is her question on line 23.

[00:22:59] Speaker 01:
This is her speaking.

[00:23:01] Speaker 01:
Correct.

[00:23:01] Speaker 01:
But then the answer starts off talking about recall response.

[00:23:06] Speaker 05:
Correct.

[00:23:06] Speaker 05:
So it is our position that that's what petitioner is quoting, that that is her misspeaking.

[00:23:12] Speaker 05:
But when you go to look at the decision, she speaks exclusively about recall.

[00:23:16] Speaker 05:
And even by the end of this conversation,

[00:23:19] Speaker 01:
She was going to ask if there's any other questions.

[00:23:22] Speaker 04:
Her very next question is recall.

[00:23:25] Speaker 04:
Her very next question at the top of the next page.

[00:23:27] Speaker 04:
Correct.

[00:23:27] Speaker 05:
What happens in the recall response?

[00:23:29] Speaker 05:
She gives him the opportunity to correct me if I'm wrong.

[00:23:33] Speaker 05:
Dr. Steinman, isn't this what recall is?

[00:23:35] Speaker 05:
And isn't it true that you don't have evidence in this record?

[00:23:39] Speaker 04:
And just like- Well, I mean, even the petitioner's answer in this instance indicates that they were understanding her question to be recall.

[00:23:47] Speaker 04:
Correct.

[00:23:48] Speaker 04:
I mean, OK.

[00:23:51] Speaker 04:
But what about this where she says there is no evidence of an immune response during the first injection?

[00:23:59] Speaker 04:
Well, I mean, it wouldn't be during the injection, right?

[00:24:02] Speaker 04:
It would be after.

[00:24:03] Speaker 04:
So that's a little sketch.

[00:24:04] Speaker 04:
But there is some evidence after.

[00:24:08] Speaker 04:
I mean, the mother took the child to the doctor after.

[00:24:11] Speaker 05:
The first injection that she was talking about was the first flu mist injection, which was actually two years before the vaccination.

[00:24:17] Speaker 04:
Do you call mist an injection?

[00:24:19] Speaker 04:
I mean, that was confusing me too.

[00:24:20] Speaker 05:
Yeah, it's the nasal one.

[00:24:23] Speaker 04:
Yeah, I mean, you spray it up your nose.

[00:24:25] Speaker 04:
That doesn't feel like it meets the definition of injection in my mind, but whatever.

[00:24:28] Speaker 04:
I'm not a doctor.

[00:24:29] Speaker 04:
Maybe it does.

[00:24:32] Speaker 04:
So you're saying after the first one, there were no symptoms?

[00:24:35] Speaker 04:
Correct.

[00:24:36] Speaker 05:
And it was Dr. Steinman's position, and I believe Respondent's argument, that they wouldn't have expected there to be.

[00:24:41] Speaker 05:
And that's where Petitioner seems to draw some sort of conclusion that the Special Master was confused.

[00:24:47] Speaker 05:
But looking at the testimony and the record as a whole in the Special Master's decision, she was not confused.

[00:24:54] Speaker 05:
She understood what he was saying, and she just found his answers lacking and his evidence lacking.

[00:24:59] Speaker 05:
And therefore, the Petitioners didn't meet their burden on Fronk 3.

[00:25:03] Speaker 01:
And this is another area where maybe I'm just being paranoid.

[00:25:06] Speaker 01:
I read the government as sort of walking away or distancing itself from what the special master found.

[00:25:13] Speaker 01:
On this other vaccine they had, Palomar, what's it called?

[00:25:17] Speaker 01:
There was another vaccine that they relapsed.

[00:25:21] Speaker 01:
Yes.

[00:25:23] Speaker 01:
The special master says this is for a different vaccine.

[00:25:26] Speaker 01:
So I'm not going to count the fact that it's two months.

[00:25:29] Speaker 01:
The government seems to not embrace that argument and argue solely, well, we're looking at four to six weeks, and that's not two months, so it doesn't count.

[00:25:38] Speaker 01:
Am I reading too much into that?

[00:25:39] Speaker 05:
Respectfully, maybe, Your Honor.

[00:25:44] Speaker 05:
I think what would help, Your Honors, would be if we looked at the appendix with respect to the four to six weeks as well as the six month quotations that the petitioner is relying on.

[00:25:59] Speaker 05:
starting with appendix at 2, 1, 4, 9.

[00:26:16] Speaker 05:
So as Respondent Setsford said in a brief, this is the data that petitioners are relying on.

[00:26:21] Speaker 01:
What is this document?

[00:26:23] Speaker 05:
This is one of the pieces of medical literature that petitioners submitted in support of their theory.

[00:26:28] Speaker 05:
And I'm looking at the paragraph under the heading Vaccination History in Cases with Onsets Since October 2009.

[00:26:35] Speaker 05:
about maybe two-thirds of the way down, there's a sentence that starts within this sample.

[00:26:41] Speaker 05:
It says, in the sample, 27 out of 150 cases recalled having been sick with an infection in a few months prior to the onset of narcolepsy.

[00:26:50] Speaker 05:
And respondents briefly point out that that is what petitioners are relying on in support of a two-month onset.

[00:26:58] Speaker 05:
But what we point to, Your Honor, is on appendix 1182.

[00:27:05] Speaker 05:
Oh, I'm sorry that may be the incorrect page one moment Actually, it's two one five zero I do apologize So it was just the very next page this is respondent support for the fact that actually There were two six months at the top of the page.

[00:27:26] Speaker 05:
Yes the last sentence in the first paragraph behind reference Yes, where it says based on animal studies

[00:27:33] Speaker 05:
Approximately 80% of cell losses needed to exhibit symptoms, possibly explaining the four to six month delay between winter infection and narcolepsy onset.

[00:27:44] Speaker 05:
So, Respondent offers that as proof against petitioners four to six week onset that actually

[00:27:50] Speaker 05:
this literature that they submitted suggests a six month delay, which would not fit their four to six month, four to six week.

[00:27:58] Speaker 04:
So your argument is that there's substantial evidence for the special masters finding about PROM 3 because their own literature had a four to six month thing in it, even if other things they submitted suggested a shorter time period?

[00:28:10] Speaker 05:
Correct.

[00:28:11] Speaker 05:
And I would add that Dr. Steinman at the hearing also indicated that

[00:28:15] Speaker 05:
the timing after the pandemic's vaccine, which was what Judge Prost asked about, was, quote, months to a lot longer.

[00:28:21] Speaker 05:
And that is at Appendix 714.

[00:28:27] Speaker 05:
Anything further?

[00:28:28] Speaker 05:
No, Your Honor.

[00:28:29] Speaker 05:
So if you have nothing further, we ask this court to affirm the opinion of the Court of Federal Claims in the decision below.

[00:28:34] Speaker 04:
OK.

[00:28:35] Speaker 04:
Thank you, Ms.

[00:28:35] Speaker 04:
Yark.

[00:28:36] Speaker 04:
Mr. Kraus, you have some?

[00:28:38] Speaker 04:
Give him two minutes for rebuttal time.

[00:28:50] Speaker 02:
So that appendix 2150, the animal study that's looking at 80% cell loss, wasn't even referenced by the special master.

[00:29:04] Speaker 02:
And it's not, we acknowledge that this literature talks about six months as the timeframe for narcolepsy to appear as a diagnosis following the flu vaccine.

[00:29:19] Speaker 02:
We're not disputing that.

[00:29:21] Speaker 02:
But that's not the issue on prong three.

[00:29:23] Speaker 02:
The issue on prong three is more immunological or scientific.

[00:29:29] Speaker 02:
It's when would you expect to see

[00:29:33] Speaker 02:
the onset of symptoms that could lead to narcolepsy.

[00:29:37] Speaker 02:
And the literature the petitioner presented is entirely consistent with the four to six week time frame, including- The problem is that hand reference could be read either way.

[00:29:48] Speaker 04:
It could be read the way you just suggested, or it could be read to be talking about the onset of symptoms.

[00:29:54] Speaker 04:
It's not specific.

[00:29:56] Speaker 04:
But I review for substantial evidence, which means I have to defer to how the lower tribunal may have chosen to read it.

[00:30:02] Speaker 02:
And respectfully, Your Honor, your comment earlier, which was sort of a common sense observation, is about the difference between a child starting to show symptoms of narcolepsy.

[00:30:17] Speaker 04:
I'm no doctor.

[00:30:18] Speaker 04:
You should not listen to anything I say.

[00:30:20] Speaker 02:
But your instincts are excellent, because that's what those experts.

[00:30:26] Speaker 02:
But Dr. Moore, no, Chief Judge Moore, the experts in this case did, in fact,

[00:30:32] Speaker 02:
agree that the diagnosis of narcolepsy is complicated, because for all the same reasons that we've previously discussed.

[00:30:38] Speaker 04:
If I was making this determination to no vote, you'd have a much stronger chance, right?

[00:30:42] Speaker 04:
But under a substantial evidence theory, I can't plant my thinking with what might be in the record to otherwise support the decision that was made.

[00:30:54] Speaker 02:
And I understand and respect that.

[00:30:55] Speaker 02:
I would just circle back to the fact that the four to six week timing for onset of symptoms is entirely consistent with literally hundreds of cases in the vaccine program that are looking at injuries caused by vaccines

[00:31:12] Speaker 02:
via molecular mimicry.

[00:31:13] Speaker 02:
That four to six week time period is, I mean, for example, the flu vaccine causing GBS is a table injury based on three to 42 days after the vaccination.

[00:31:24] Speaker 02:
So this is a time frame that we're all comfortable with as being appropriate for a vaccine to cause the onset of autoimmune symptoms.

[00:31:35] Speaker 02:
Thank you, Your Honor.

[00:31:38] Speaker 04:
I thank both counsels.

[00:31:39] Speaker 04:
This case is taken under submission.