[00:00:38] Speaker 00:
Okay, the next argued case is number 19, 1753, Sanchez against Health and Human Services.

[00:00:47] Speaker 00:
Ms.

[00:00:47] Speaker 03:
Rufus Moore.

[00:00:49] Speaker 03:
Good morning, Your Honor.

[00:00:52] Speaker 03:
We're here today to decide whether or not the special master was arbitrary and capricious as well as committed legal error.

[00:01:01] Speaker 03:
I would like to remind the court that the special master found prong one of alfen that we had met our burden in terms of providing a medically plausible theory.

[00:01:17] Speaker 03:
and in doing so he concluded that the vaccine could cause the fever and the inconsolable crime and the basis of that was primarily in addition of course to we had considerable expert testimony but I think he mostly relied upon the vaccine pamphlet which clearly showed that

[00:01:41] Speaker 03:
The vaccine could cause fever and inconsolable crying.

[00:01:46] Speaker 01:
Let me ask you a question.

[00:01:48] Speaker 01:
So when you have that, you arrive at that point in the road on these vaccine cases and the special master finds that

[00:01:58] Speaker 01:
Something could have happened.

[00:02:01] Speaker 01:
So it's in the balance.

[00:02:02] Speaker 01:
When the special master uses those words, I imagine he's saying it could have, but could not have.

[00:02:10] Speaker 01:
Which is possible, it's not possible.

[00:02:11] Speaker 01:
When it's in that balance, and given that this is a remedial statute, should the special master decide, decision fall in favor of the victim?

[00:02:24] Speaker 03:
Well, given the remedial and I know there's some debate of whether or not the remedial provisions should trump sovereign immunity, I would contend and submit that the petitioner should get the benefit of the doubt, especially in light of this being a remedial program.

[00:02:50] Speaker 03:
In addition to the

[00:02:52] Speaker 03:
The fever on February 5th.

[00:03:11] Speaker 03:
Correct.

[00:03:11] Speaker 03:
Right.

[00:03:12] Speaker 04:
But not necessarily the fever on February 16th.

[00:03:15] Speaker 03:
That's correct.

[00:03:16] Speaker 03:
But the fever on the 5th is what started the whole domino, the whole cascade of intents.

[00:03:21] Speaker 04:
Well, that's sort of the question in the case.

[00:03:24] Speaker 03:
Well, that's what petitioners' intents.

[00:03:26] Speaker 03:
That's your position.

[00:03:27] Speaker 03:
Absolutely, Your Honor.

[00:03:30] Speaker 03:
And if I'm

[00:03:31] Speaker 03:
might go back to the palate case, which this court also decided that was the position of the petitioner as well.

[00:03:41] Speaker 03:
That when you start with, you know, fever and these other encephalopathic symptoms, that is the initial phase that starts the ball rolling and then the

[00:03:54] Speaker 03:
other manifestations can occur weeks to months later and our experts testified very consistently to the expert testimony in Palak.

[00:04:10] Speaker 03:
The legal error that we believe has occurred in this case then is both in pronged

[00:04:19] Speaker 03:
and I'd like to first draw our attention to prong three, the timing, which I think was a considerable amount of time was put forth in the decision on trying to decide timing in this case.

[00:04:36] Speaker 03:
And we would submit that had the special master followed this court's decision in Markovitch, then the first onset symptom, and there's only one onset symptom pursuant to Markovitch, the first onset symptom was the fever and arguably the inconsolable crying, but absolutely

[00:05:01] Speaker 03:
The first onset symptom was fever, and we would also contend the inconsolable crying.

[00:05:08] Speaker 03:
What happened, however, instead of following Markovitch, we leapt over first onset sign, which, and I'll backtrack a little bit, I believe the language is that

[00:05:24] Speaker 03:
These first onset signs need to be objectively recognizable in the medical community.

[00:05:31] Speaker 03:
And I would submit they are.

[00:05:32] Speaker 03:
It's in the vaccine pamphlet.

[00:05:35] Speaker 03:
So it has to be objectively recognizable.

[00:05:39] Speaker 04:
Here's where I have a problem with the way you're laying this out.

[00:05:42] Speaker 04:
There's no doubt that I don't think anybody would dispute that the child had a reaction to the vaccine.

[00:05:50] Speaker 04:
Correct.

[00:05:50] Speaker 04:
And it was a classic reaction to a vaccine.

[00:05:53] Speaker 04:
A fever, a hot spot, and so forth.

[00:05:56] Speaker 04:
So there's no doubt about that.

[00:05:57] Speaker 04:
The question though is, was there something that happened at that moment that was neurologically significant other than the normal reaction that a sensitive child would have to a vaccine?

[00:06:12] Speaker 04:
Or was there something later that happened that constituted the onset?

[00:06:16] Speaker 04:
I thought that the principle theory here really was

[00:06:20] Speaker 04:
that it was the cold, or whether it was a cold or not, the events of the February 16th that reflected the onset of the neurological condition, the vaccine, having simply prepared the child for vulnerability to what later happened on the 16th.

[00:06:47] Speaker 04:
Isn't that a fair characterization of your position?

[00:06:50] Speaker 03:
If I might add to it that when you're dealing with a child that has Lays disease, then when you are subjected to the vaccine and then the fever and inconsolable crying, which our experts did characterize as a neurodegenerative event,

[00:07:19] Speaker 03:
Then the oxidative stress on that child, it's already, the ball is already rolling on that.

[00:07:28] Speaker 03:
And then you don't need to have, at least according to Markovich, the first manifestation, which is the neurological manifestation.

[00:07:40] Speaker 03:
I would also submit that we do have a first neurological manifestation.

[00:07:47] Speaker 03:
And that was the new finding by the special master of arm contortions.

[00:07:52] Speaker 04:
That was on the 16th.

[00:07:53] Speaker 04:
That's correct.

[00:07:55] Speaker 04:
That didn't start the ball.

[00:07:56] Speaker 04:
As I understand it, inconsolable crying is consistent with a reaction to the vaccine that is not neurological, or at least doesn't have neurological implications.

[00:08:06] Speaker 04:
Isn't that right?

[00:08:08] Speaker 04:
Isn't that in the packet insert?

[00:08:10] Speaker 04:
So the inconsolable crying at the time of the administration of the vaccine doesn't really tell us much about whether that is the beginning of neurological degeneration, right?

[00:08:25] Speaker 03:
I believe that's correct.

[00:08:27] Speaker 03:
But it certainly starts as a first onset symptom pursuant to Markovitch, just like blinking as a generalized reaction.

[00:08:36] Speaker 03:
You kind of look retrospectively as to what's happening.

[00:08:40] Speaker 03:
And that started the ball rolling.

[00:08:43] Speaker 03:
And it's recognizable by the medical community.

[00:08:46] Speaker 03:
It's recognized by our experts, definitely.

[00:08:50] Speaker 03:
And even if that wasn't enough, then

[00:08:54] Speaker 03:
But ten days later, you do have the arm contortions, and I realized that the Special Master did characterize the arm contortions as consistent with a cold.

[00:09:06] Speaker 03:
But I'd be very interested in seeing the evidence of that.

[00:09:12] Speaker 03:
I haven't seen it thus far.

[00:09:14] Speaker 03:
It's not been in the briefs.

[00:09:18] Speaker 03:
Definitely our experts said arm contortions, you know, unlike maybe startling awake, you know, because you have a stuffy nose, but definitely these arm contortions, which are outlined in Dr. Haas's medical records, they're

[00:09:36] Speaker 03:
There is no evidence that that is consistent with a cold.

[00:09:40] Speaker 03:
Dr. Steinman said it wasn't consistent.

[00:09:42] Speaker 03:
Dr. Nyazov said it wasn't consistent.

[00:09:44] Speaker 03:
Respondent's expert, Dr. Raymond, never specifically addressed the arm contortions as being consistent with a cold.

[00:09:55] Speaker 03:
I just couldn't find it.

[00:09:57] Speaker 04:
Of course, at that point, what's awkward about the record is at that point, the special master had found there hadn't been any arm contortions in his

[00:10:06] Speaker 04:
In his initial factual findings, so there's no reason for anybody to address arm contusions.

[00:10:10] Speaker 03:
I agree.

[00:10:11] Speaker 03:
We did, though.

[00:10:12] Speaker 03:
Because it was a fact in the case.

[00:10:17] Speaker 03:
And of course, yeah, it is awkward.

[00:10:21] Speaker 03:
But that's part of the thing.

[00:10:23] Speaker 03:
There is no evidence that it's consistent with occult.

[00:10:27] Speaker 03:
We contend it's an impermissible diagnosis by a special master.

[00:10:32] Speaker 01:
At this point, were you able, did you have the opportunity to get your own expert or to get any evidence on this question, whether the arm contortion was consistent with the cold or not?

[00:10:47] Speaker 03:
Yes, Dr. Steinman specifically testified that it was not consistent with the cold.

[00:10:58] Speaker 03:
So those arm contortions did commence the 10 days afterwards.

[00:11:04] Speaker 03:
And what we believe happened in the decision is that then the special master kind of leapt from first onset symptoms and went straight to manifestations, which again I think is a legal error.

[00:11:25] Speaker 03:
The manifestations that he relied upon was loss of skills, regression.

[00:11:30] Speaker 03:
Well, that's not the only manifestation of Lay's disease.

[00:11:37] Speaker 03:
And so there's an article by Sofu that was outlined in Dr. Steinman's expert report at Appendix 454 through 55 in Table 1 that specifically outlines

[00:11:51] Speaker 03:
manifestations of Lay's disease, which includes abnormal motor findings and dystonia.

[00:11:57] Speaker 03:
And we would contend that these arm contortions, as Dr. Steinman testified, are in fact dystonic posturing.

[00:12:05] Speaker 03:
Dr. Haas in his medical records also, after he describes the arm contortion posturing, also concludes in his medical records dystonia.

[00:12:17] Speaker 03:
So even if

[00:12:19] Speaker 03:
The fever and inconsolable crying were not the first onset symptom that we look at for Prong 3.

[00:12:27] Speaker 03:
We have the abnormal arm contortions, and there is no evidence that it's consistent with a cold.

[00:12:37] Speaker 03:
And even if we don't buy that,

[00:12:41] Speaker 03:
and I want to reserve my rebuttal time.

[00:12:45] Speaker 03:
I know that this court has looked very heavily at the literature that was also provided in Palick, and that was the Schaffner, the Edmonds, and the polling case, but we also provided literature by Dr. Navio, who was a co-author of Edmonds and a peer reviewer of Schaffner, so that literature

[00:13:10] Speaker 03:
gave us additional evolution of how we get manifestations weeks to months.

[00:13:21] Speaker 03:
It doesn't have to be within seven days.

[00:13:23] Speaker 03:
It doesn't have to be within 19 days.

[00:13:26] Speaker 03:
It can go on weeks to months, and I'd like to reserve the rest for rebuttal.

[00:13:33] Speaker 00:
Let's hear from the Governor.

[00:13:36] Speaker 00:
Ms.

[00:13:37] Speaker 00:
Perlman.

[00:13:37] Speaker 02:
Thank you, Your Honor.

[00:13:38] Speaker 02:
May it please the Court

[00:13:40] Speaker 02:
The child in this case has a severe genetic condition caused by two mutations in his nuclear DNA.

[00:13:46] Speaker 02:
And there's no question that, but for these mutations, he would not have developed his LACE syndrome.

[00:13:52] Speaker 00:
Isn't this, I'm glad you mentioned, this is the problem, isn't it?

[00:13:55] Speaker 00:
A little too much knowledge.

[00:13:57] Speaker 00:
At the time the Vaccine Act was enacted, this sort of sequence of events and immediate

[00:14:06] Speaker 00:
reaction from the infant to the vaccine followed in quite a short time with a very serious, in this case neurological, often fatal response was exactly the kind of situation that the Vaccine Act was intended to respond to because

[00:14:31] Speaker 00:
was refraining some people from participating in vaccinations because of fear.

[00:14:40] Speaker 00:
Now we have a little too much knowledge.

[00:14:44] Speaker 00:
Now we know that this infant had, the record says, two genetic aberrations whereby this neurological result was likely or at least explainable

[00:15:00] Speaker 00:
Why should that diminish the role of the Vaccine Act for compensation?

[00:15:08] Speaker 00:
Until we get to the point where every infant has its genome analyzed to determine if it has such a propensity, apparently less than 1% may.

[00:15:22] Speaker 00:
Then we'll have the same kind of sequence of results, but now we say you were born that way, so the Vaccine Act doesn't apply to you.

[00:15:32] Speaker 00:
This is what troubles me about these cases.

[00:15:34] Speaker 00:
This isn't the first that we've seen with this kind of event.

[00:15:38] Speaker 02:
Yes, Your Honor.

[00:15:40] Speaker 02:
The Vaccine Act, as you know, was created to compensate individuals who were injured by vaccines.

[00:15:47] Speaker 02:
And in an off-table case like this, petitioners need to show by preponderant evidence that the vaccine was a but for cause of the particular reaction.

[00:15:57] Speaker 04:
Or aggravated.

[00:15:59] Speaker 02:
Correct.

[00:16:00] Speaker 04:
Right.

[00:16:01] Speaker 04:
But the argument that Dr. Steinman made

[00:16:04] Speaker 04:
In addressing this precise point is that sure he had a problem that was

[00:16:12] Speaker 04:
at some point it manifests itself but as I understand his testimony the gist of it is that the later that it manifests itself the better off he would have been and therefore he had a wide variety of possible outcomes one of which was that it never would have manifested itself although that was unlikely and why isn't that enough to say that the vaccine by

[00:16:38] Speaker 04:
Causing the reaction that it caused, if it did, when it did, made a difference that's important for purposes of vaccine net compensation.

[00:16:49] Speaker 02:
Okay.

[00:16:49] Speaker 02:
You brought up a few issues that I would like to address.

[00:16:52] Speaker 02:
No, but it's all wrapped into one.

[00:16:53] Speaker 02:
Yes, well, your initial statement about the fact that Dr. Simon testified that the child may have eventually wound up or may not have wound up with Lay's disease, the Special Master specifically found the opposite in the decision, and this part was not challenged by

[00:17:12] Speaker 02:
This is on page 41 of his report, right at the end of the report.

[00:17:26] Speaker 02:
Plus 12 pages.

[00:17:29] Speaker 04:
And that's the part in which he says, I'm not deciding this case on this basis.

[00:17:33] Speaker 04:
So I don't know that you seem to be suggesting that maybe we should decide this case on that ground.

[00:17:39] Speaker 02:
No, Your Honor.

[00:17:40] Speaker 04:
That's not what I'm suggesting.

[00:17:41] Speaker 04:
So if we take only the question of whether there was some result

[00:17:47] Speaker 04:
incremental result as a result of the vaccine, why isn't that enough to justify some form of compensation?

[00:17:57] Speaker 02:
Because there is no factual evidence in the record, and the special master found this, of any type of neurodegeneration within temporal proximity of the vaccine.

[00:18:07] Speaker 02:
Ms.

[00:18:07] Speaker 02:
Rockmore suggested that fever and inconsolable crying are evidence of neurodegeneration.

[00:18:14] Speaker 02:
How about the arm contortions?

[00:18:15] Speaker 02:
The arm contortions.

[00:18:16] Speaker 02:
February 16th.

[00:18:17] Speaker 02:
Correct.

[00:18:18] Speaker 02:
Actually, Dr. Raymond did speak to the arm contortions in one of his expert reports, and it is at appendix page 816.

[00:18:26] Speaker 02:
And he was talking about the contortion of the arms and says, pushing arms behind the back is not a recognized movement during seizures.

[00:18:37] Speaker 02:
And it was seizures that Dr. Steinman was referring to.

[00:18:40] Speaker 02:
So if there is no evidence of any neurodegeneration within three months of the vaccines, there is no factual basis that the vaccines somehow contributed to

[00:18:54] Speaker 02:
the child's course.

[00:18:56] Speaker 04:
But the argument that I understand was made with respect to the contortions was predicated on the fact that the special master initially said that there were no contortions and then later said that there were.

[00:19:09] Speaker 04:
But the argument seemed to be that the contortions were consistent with a cold.

[00:19:17] Speaker 04:
What evidence is there that arm contortions are consistent with a cold?

[00:19:22] Speaker 02:
Judge Campbell Smith in her opinion did cite some language from our pediatric immunologist.

[00:19:32] Speaker 04:
Point to me in the record.

[00:19:34] Speaker 04:
Because this is important.

[00:19:36] Speaker 04:
And I looked hard to find evidence supporting the theory that there was a relationship between the arm contortions and a cold.

[00:19:46] Speaker 04:
And the only things I could find were two statements.

[00:19:52] Speaker 04:
that didn't really seem to me to go that far, made by Dr. Raymond and I guess Dr. McGathey.

[00:20:00] Speaker 04:
Yeah, can you discuss those two pieces of evidence?

[00:20:03] Speaker 04:
Because that's, to me this is a really critical point in the case.

[00:20:06] Speaker 02:
Well, as you acknowledged earlier, this information was not part of the fact pattern that the experts were asked to speak to.

[00:20:15] Speaker 02:
So obviously there is some disadvantage and the record does not fully go into it.

[00:20:20] Speaker 04:
Right, but in the hearing this issue was raised and the question was presented to Drs.

[00:20:27] Speaker 04:
Raymond and Megedi about what evidence there is that our contortions are indicative of a cold.

[00:20:33] Speaker 02:
I believe that, and Dr. Raymond in particular, addressed the issue more of were these arm contortions or any of the symptoms that were exhibited from the day of the vaccine through 12 days after indicative of neurodegeneration.

[00:20:49] Speaker 02:
That is the question at issue.

[00:20:51] Speaker 02:
is when did the Lay's syndrome first manifest itself?

[00:20:56] Speaker 04:
But he wasn't talking about the armed contortions, as I understand his testimony.

[00:21:00] Speaker 04:
He would have the portion of his testimony in which he addresses the whole consistent with a cold issue.

[00:21:07] Speaker 02:
If you happen to have the appendix number.

[00:21:12] Speaker 04:
Well, let's see.

[00:21:13] Speaker 04:
I have it here somewhere.

[00:21:23] Speaker 04:
731 of the transcript number on the upper right-hand corner.

[00:21:42] Speaker 04:
Well, I'm working from the transcript, you're working from the appendix.

[00:21:47] Speaker 02:
Is it appendix 743 at page 731?

[00:21:49] Speaker 02:
Yes.

[00:21:51] Speaker 02:
Yes, okay.

[00:21:52] Speaker 02:
This is Dr. McGatey, who is speaking.

[00:21:56] Speaker 02:
And he was asked, do you think the inconsolable crying that Tristan had shortly after the February 5th vaccines were caused by the vaccine?

[00:22:03] Speaker 02:
He said, I think it very well may have been.

[00:22:06] Speaker 02:
And he goes on to describe that these are normal reactions that you have to vaccines.

[00:22:11] Speaker 04:
Inconsolable crying, but he doesn't say the same about arm contortions.

[00:22:14] Speaker 02:
Well, this particular discussion dealt with the day of the vaccines where arm contortions are not a question.

[00:22:22] Speaker 02:
OK, well, let me get cut to the chase here.

[00:22:25] Speaker 02:
Sure.

[00:22:26] Speaker 04:
Is there any evidence?

[00:22:28] Speaker 04:
Ms.

[00:22:28] Speaker 04:
Rockmore says there's no evidence in the record.

[00:22:31] Speaker 04:
that there is a relationship between arm contortions and a cold.

[00:22:38] Speaker 04:
Do you have anything to point to that says that's not so?

[00:22:44] Speaker 02:
I do not, but I would say that there is no evidence in the record to show that it's part of any type of neurodegenerative process.

[00:22:52] Speaker 02:
And that is what petitioners had the burden to show, is to show that this symptom is related to

[00:22:58] Speaker 04:
I think that was the gist of Dr. Steinmetz's testimony as to the events of February 16th.

[00:23:05] Speaker 02:
But as Dr. Raymond pointed out, you would not have, first of all, arm contortions are not evidence of a seizure or any type of neurologic condition, and that's what Dr. Raymond, the site I gave you earlier, what he testified to.

[00:23:19] Speaker 02:
But Dr. Raymond also stressed that in neurology, you don't have a symptom, something happened,

[00:23:26] Speaker 02:
and then have nothing happen for several months.

[00:23:28] Speaker 02:
It just doesn't happen.

[00:23:30] Speaker 02:
That's inconsistent, and I can get you a site for that.

[00:23:32] Speaker 04:
Of course, the petitioner's theory is that things were happening, it's just that they weren't manifesting themselves, because we're talking about a very young child, and developmental regression is hard to spot.

[00:23:45] Speaker 02:
Correct.

[00:23:46] Speaker 02:
But there is evidence of neurodegeneration.

[00:23:49] Speaker 02:
At any age, you can see it.

[00:23:51] Speaker 02:
Ms.

[00:23:53] Speaker 02:
Rockmore cited the Navio article, this is appendix at 398, for some of the symptoms you would see in this regression.

[00:24:00] Speaker 02:
And it would include that the child became difficult to fully awaken.

[00:24:07] Speaker 02:
He will stop walking, talking, stiffen or lose muscle tone, have a seizure or a stroke-like episode.

[00:24:12] Speaker 02:
None of those happened, and more importantly, Dr. Navio went on to say, it involves an energy failure that can lead to a series of neurodegenerative events and even death over the next two to three months.

[00:24:25] Speaker 02:
There is no series here.

[00:24:27] Speaker 02:
There is simply the absence of evidence of anything except for

[00:24:31] Speaker 02:
This child had a series of upper respiratory infections, which happened to be a known precipitant of the Lay's syndrome, which she was diagnosed with.

[00:24:42] Speaker 04:
What do you say about the challenge-re-challenge argument?

[00:24:46] Speaker 04:
The point being that there was evidence that between August 7th and October, I guess it was 7th,

[00:24:54] Speaker 04:
was seen for the first time after the second vaccinations, there was evidence of further deterioration in his condition.

[00:25:04] Speaker 04:
That appears to be true.

[00:25:07] Speaker 04:
Would you agree that the evidence, he was worse off on October 7th than he was on August 7th?

[00:25:13] Speaker 02:
Yes, that is part of the typical decline of Lay's syndrome, but challenge re-challenge by definition requires the same adverse event happening after the first vaccine and after the second vaccine.

[00:25:29] Speaker 02:
Dr. Simon said he had seizures after the first vaccine and then he had seizures again.

[00:25:36] Speaker 02:
The record from October 7th, which was six weeks after the vaccine,

[00:25:41] Speaker 02:
and this is appendix at 124, said that they denied any new complaints, denied seizures, no weakness, no ticks.

[00:25:51] Speaker 02:
There's no evidence that anything other than the normal course of Lay's syndrome, which is a progressive, devastating neurologic disease, the child was just continuing on the course that he would have gone on.

[00:26:02] Speaker 02:
Nothing overt happened.

[00:26:05] Speaker 02:
And this is important for the Pollock analogy that

[00:26:09] Speaker 02:
uh, petitioners are trying to make the facts situation the same thing as Pollock and it simply is not in Pollock.

[00:26:16] Speaker 02:
There was a very clear neurodegenerative event 23 days after the vaccine and that is something that this court

[00:26:25] Speaker 02:
repeated time and again in the decision the child had a rapid and devastating a precipitous and well documented a pronounced neurologic decline after the vaccine and he never got better that is completely different than the situation we have here where he had some

[00:26:44] Speaker 02:
symptoms of something.

[00:26:46] Speaker 02:
The special master believed it was a cold.

[00:26:48] Speaker 02:
We state there's nothing to say it wasn't a cold and there's certainly nothing to show that it's neurodegenerative.

[00:26:55] Speaker 02:
And then, I'm sorry, and then nothing happened.

[00:26:58] Speaker 02:
It's completely different than the fact situation in Pollock.

[00:27:02] Speaker 04:
What about the fact that the special master didn't address the challenge-re-challenge issue?

[00:27:06] Speaker 04:
And so we really don't know, we don't have findings from the special master, at least conclusions from the special master as to that theory of degeneration coming from the second.

[00:27:21] Speaker 02:
There's no factual basis for the theory.

[00:27:23] Speaker 02:
The special master in his factual finding said that none of the things that petitioners rely on for their challenge-re-challenge theory

[00:27:32] Speaker 02:
They didn't happen.

[00:27:34] Speaker 02:
So there's no reason for him to discuss something that there's no evidence of.

[00:27:38] Speaker 04:
But he did get worse, and that's indisputable, right?

[00:27:41] Speaker 02:
But that's not what challenge re-challenge is.

[00:27:44] Speaker 04:
But it's part of proof of challenge re-challenge is that suddenly, after either some period of stability, the child suddenly gets worse.

[00:27:55] Speaker 02:
Well, the definition of re-challenge, and this is from the Institute of Medicine, re-challenge is an adverse event that occurred after more than one administration of a particular vaccine in the same individual.

[00:28:05] Speaker 02:
Each challenge in a patient, however, must meet the same attributes of reasonable latency, documentation of vaccine receipt, and clinician diagnosis of the health outcome.

[00:28:15] Speaker 02:
That does not describe what happened with the facts that we have before us in this case.

[00:28:21] Speaker 02:
The child, and in Locaine this court spoke to it, what is the normal progression of the disease?

[00:28:27] Speaker 02:
There's nothing in the child's medical records at all to show that he did anything other than what was expected of a child with Lay's disease.

[00:28:39] Speaker 02:
The only thing that makes him different is that he is still alive, which is terrific, but he is actually doing better than almost all the other children who unfortunately don't make it.

[00:28:51] Speaker 04:
Do you think, if we were to disagree with you with respect to the findings regarding the cause of his onset of conditions, neurodegenerative conditions that ultimately constituted Lay's disease,

[00:29:10] Speaker 04:
Do you think we would need to remand for the Special Master to make a ruling on the issue that he discussed at the very end of his decision regarding the point you began with, which was he would have been in the same situation even had he never had a vaccination?

[00:29:32] Speaker 02:
I don't think so.

[00:29:33] Speaker 02:
I think he explained his position.

[00:29:36] Speaker 04:
And again, petitioners... Well, but he declined to rule on that.

[00:29:39] Speaker 04:
So my question to you is if you lose on... I'll put it bluntly.

[00:29:43] Speaker 04:
If you lose on everything else, do you think you're entitled to a remand on that issue?

[00:29:49] Speaker 04:
If that is the route the court wants to take, then perhaps, but... I'm actually looking to you to ask if that is legally... Do you think you are legally entitled to a remand on that issue?

[00:29:59] Speaker 02:
Yes, I do.

[00:30:00] Speaker 02:
I just would like to say one more thing, Your Honor, is that your disagreement with the Special Master's fact-finding is not enough under this Court's precedent to overturn the decision.

[00:30:11] Speaker 02:
You have to find that his decision is arbitrary and capricious.

[00:30:16] Speaker 02:
The record, and it's a significant one, shows that the contemporary news medical records, the child's treating physicians, the reports of the parents, and two experts in pediatrics that we had, that petitioners did not put forth, all said that there is no evidence of neurodegeneration.

[00:30:34] Speaker 02:
So we would respectfully ask that you affirm the special master's findings.

[00:30:40] Speaker 00:
Thank you, Ms.

[00:30:44] Speaker 00:
Tormann.

[00:30:44] Speaker ?:
Thank you.

[00:30:44] Speaker ?:
Ms.

[00:30:44] Speaker ?:
Rokman.

[00:30:53] Speaker 03:
A lot to address.

[00:30:56] Speaker 03:
On the remand issue, because the special master made it clear that it wasn't part of his ruling, we considered it dicta.

[00:31:08] Speaker 03:
I don't know why it was

[00:31:11] Speaker 04:
memorialized it was he said for the record it's for the record which i assume means that in the event that something goes awry that this is his position on that issue and then if it gets remanded then

[00:31:26] Speaker 03:
I would say similar to other cases that have been remanded to him.

[00:31:32] Speaker 03:
We'll be right back here for sure.

[00:31:35] Speaker 03:
Because we were not, you know, obviously we didn't address the issue.

[00:31:40] Speaker 01:
On what point can we just straight out reverse that?

[00:31:44] Speaker 03:
I think on legal error, on failure to follow Markovitch, legal error on deciding challenge, re-challenge.

[00:31:54] Speaker 03:
Just in and of itself right there, I think kind of lumping Prong 2 and 3 together and not addressing all the other Prong 2 events like the treating doctors that were implicating the vaccine, that the vaccine acted consistent with what we would see in a child.

[00:32:24] Speaker 03:
Of course, the re-challenge and challenge is a big one for Prong 2 as well.

[00:32:31] Speaker 01:
Okay.

[00:32:32] Speaker 01:
I meant to ask your opponents, but it escaped me.

[00:32:39] Speaker 01:
But it seems to me that the parents also presented evidence of arm contortions shortly after the vaccines were taken.

[00:32:51] Speaker 03:
Is that correct?

[00:32:51] Speaker 03:
They did.

[00:32:54] Speaker 03:
They did.

[00:32:55] Speaker 03:
But the original findings of fact found that the arm contortions happened way later.

[00:33:03] Speaker 03:
And then later on, after the entitlement hearing with the experts, he changed his mind, apparently based on what he perceived that he saw in the medical records, and found that they did occur 10 days later.

[00:33:22] Speaker 03:
On challenge-re-challenge,

[00:33:23] Speaker 03:
I would like to also make sure the court realizes that the experts relied on Special Master's fact findings.

[00:33:34] Speaker 03:
So that's why we included the charts in the appendix of what they relied upon while they were testifying to challenge, re-challenge during the entitlement hearing.

[00:33:48] Speaker 03:
So they were based on his facts that he presented, not

[00:33:53] Speaker 03:
not the parent testimony and not just little blurbs of medical records which you know these injuries it's not like a car accident where

[00:34:08] Speaker 04:
Let me ask you, with respect to the challenge re-challenge, why is it not possible to read, in light of the Special Master's findings and the record, to read the events from, say, June on through to November as being essentially a steady state of deterioration during that period?

[00:34:34] Speaker 04:
with respect to the vaccination having no particular impact.

[00:34:40] Speaker 03:
Моя предсказуемость в том, что ребенок был стабилизован перед вторым сетом вакциентов, а потом он получил еще второй удар.

[00:34:53] Speaker 03:
Это что случилось.

[00:34:56] Speaker 04:
Я искал этого, и я не нашел ничего, чтобы предсказать это.

[00:35:00] Speaker 04:
В факте, мать's предсказуемость была, что я почувствовал два-три месяца назад,

[00:35:10] Speaker 04:
falling, regressing.

[00:35:13] Speaker 04:
And I didn't see anything to suggest that, but he stabilized until August 8th and then Kapawi, he hit the wall.

[00:35:22] Speaker 04:
I didn't see anything to that effect.

[00:35:23] Speaker 04:
Is there anything I missed?

[00:35:27] Speaker 03:
As to the mother's testimony, our hands were kind of tied by the fact rulings, and if I can point to appendix 522 and 523, which are the charts that the experts relied upon, at least petitioners' experts, where you're

[00:35:47] Speaker 03:
You have the initial hit, you have the immediate fever and inconsolable crying, the ebbing and the flowing, the fever, arm contortions, losing skills, and then you have kind of the rigid, limp contortions that were happening.

[00:36:03] Speaker 03:
But after the second set, we add

[00:36:10] Speaker 04:
even more symptoms, because according to the expert testimony... He was doing fine between June and August.

[00:36:19] Speaker 04:
I didn't see that.

[00:36:20] Speaker 04:
I thought he was losing skills.

[00:36:23] Speaker 03:
So before the second set of... He was, as I believe Dr. Nyazov testified, that he kind of plateaued

[00:36:35] Speaker 01:
I'm looking at Appendix 251, and it's part of that timetable that goes into the second set.

[00:36:44] Speaker 01:
I don't see anything in there indicating an improvement.

[00:36:48] Speaker 01:
In fact, it ends with the Jennifer's baby shower, and they remembered over that day the symptoms that the child was exhibiting.

[00:37:08] Speaker 03:
And I do recall Dr. Nyau's testimony where he thought that based on what was going on and based on even the fact rulings that he had plateaued, and then when he got the second set of vaccines, he got similar symptoms and even worse.

[00:37:33] Speaker 04:
He did not have a physical reaction to the second vaccine, if I recall correctly.

[00:37:41] Speaker 04:
Is that right?

[00:37:41] Speaker 04:
In other words, he didn't have a fever and didn't have a hot spot and so forth.

[00:37:47] Speaker 03:
I do not recall any evidence to that effect.

[00:37:49] Speaker 03:
I think that was just the end.

[00:37:53] Speaker 03:
Thank you.

[00:37:54] Speaker 03:
If there's any further questions.

[00:37:57] Speaker 00:
Thank you both.

[00:37:58] Speaker 00:
The case is taken under submission.

[00:38:00] Speaker 00:
Thank you, Your Honor.