[00:00:00] Speaker 03:
We have three argued cases this morning.

[00:00:02] Speaker 03:
The first one is number 242161, Anclum versus HHS.

[00:00:09] Speaker 03:
Mr. Webb.

[00:00:11] Speaker 03:
Thank you.

[00:00:13] Speaker 02:
I want to thank the court for the accommodations they've made for my difficulty hearing.

[00:00:19] Speaker 02:
The captioning device helps a great deal.

[00:00:22] Speaker 02:
But I depend on both hearing, and I have a specialized microphone here, and the captioning device.

[00:00:30] Speaker 02:
And I'll try my very best to hear and respond to your questions.

[00:00:36] Speaker 02:
And may it please the court.

[00:00:38] Speaker 02:
I want to begin with the question of whether the Court of Federal Claims judge abused his discretion when he denied the Anclums motion to remand their case to the special master to consider the Gould article.

[00:00:57] Speaker 02:
That's the final, the fourth section of my brief.

[00:01:01] Speaker 02:
The Gould article is video analysis of unexplained deaths in toddlers.

[00:01:12] Speaker 02:
It establishes that febrile seizures can cause some cases.

[00:01:18] Speaker 02:
Let me say that again.

[00:01:19] Speaker 02:
The Gould article establishes that febrile seizures cause some cases of sudden unexplained death in childhood.

[00:01:25] Speaker 00:
Was there not other evidence already in the record on that theory that seizures, there is a correlation between seizures and SIDS?

[00:01:37] Speaker 02:
There was a great deal of evidence on that issue before.

[00:01:41] Speaker 02:
None quite so strong as the Gould article.

[00:01:45] Speaker 00:
What do you mean so strong?

[00:01:48] Speaker 02:
What was the strength of the Gould?

[00:01:50] Speaker 02:
It describes actual observation of seizures that occurred immediately before the death in six children that died of deaths classified as sudden unexplained death in childhood.

[00:02:05] Speaker 02:
So the evidence in the record before the special master

[00:02:11] Speaker 02:
included medical literature that in which the authors concluded that seizures probably caused some cases of sudden unexplained death in childhood.

[00:02:24] Speaker 02:
But the seizures themselves had not been observed.

[00:02:27] Speaker 01:
Counsel, do you agree at least that the Gould article does not provide specific evidence on whether N.A.

[00:02:36] Speaker 01:
specifically suffered a seizure leading to her death?

[00:02:44] Speaker 02:
I'm trying to make sure I answer that correctly, because I believe it does provide evidence that MA suffered a seizure.

[00:02:53] Speaker 02:
And let me explain that.

[00:02:57] Speaker 02:
It provides context.

[00:03:01] Speaker 02:
I believe that the evidence that her death was classified as a sudden unexplained death in childhood and the fact that seizures

[00:03:12] Speaker 02:
that the Gould article provides strong evidence that sudden unexplained death in childhood is strongly associated with seizures, means that it's like if you had a man.

[00:03:30] Speaker 03:
You're saying it's evidence that she suffered a seizure because she had suffered an unexplained death.

[00:03:38] Speaker 02:
I'm sorry, that again, please.

[00:03:40] Speaker 03:
You're saying that the fact that there was an unexplained death is itself evidence that a seizure occurred.

[00:03:48] Speaker 02:
That's exactly correct.

[00:03:52] Speaker 02:
And what I'm trying to say, I think, is this.

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If a man is found dead in an open pasture, and you're trying to ask the question, what caused that man's death?

[00:04:08] Speaker 02:
It matters that he was found in that pasture immediately after a thunderstorm.

[00:04:19] Speaker 02:
That makes it much more likely that he was struck by lightning than if you didn't know that.

[00:04:26] Speaker 02:
The children at the age of Nora Angklam, 12 months or older, are able to turn sideway

[00:04:36] Speaker 02:
or roll over if they have respiratory problems.

[00:04:40] Speaker 02:
So there's a real reason to believe that something caused the child to die that night.

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And the cause that has been identified in cases classified as sudden unexplained death in childhood has been febrile seizures.

[00:05:04] Speaker 02:
And so I think that the context of her death, both in terms of her death being SUDC and in the context of it being seven days after an MMRV vaccine that causes seizures, there's strong evidence.

[00:05:23] Speaker 02:
It provides evidence and inference that she's had a seizure.

[00:05:30] Speaker 01:
So at least you just used the word inference.

[00:05:32] Speaker 01:
So I think it sounds like you do agree

[00:05:34] Speaker 01:
It's not direct evidence.

[00:05:36] Speaker 01:
You may still be arguing it's indirect evidence to support your theory.

[00:05:40] Speaker 01:
I'm talking about the Gould article.

[00:05:42] Speaker 02:
I think that in terms of that she had seizure, I think that the Gould article provides direct evidence on the question of whether febrile seizures can cause or do cause some cases of SUDC.

[00:06:02] Speaker 02:
The evidence that she suffered a seizure from the Gould article is indirect evidence, because it provides context, which provides an inference that the seizure occurred.

[00:06:16] Speaker 00:
But did the case that existed before the special master, in your view, did that turn on whether or not there was a correlation between seizures and SUDC?

[00:06:32] Speaker 00:
And there's no evidence of causation.

[00:06:36] Speaker 00:
But that wasn't disputed by the government, right?

[00:06:40] Speaker 00:
That seizures, there is or is not some correlation between seizures and SUDC.

[00:06:49] Speaker 02:
I'm sorry.

[00:06:49] Speaker 02:
Sometimes I need to read the caption in as well here.

[00:06:57] Speaker 02:
I don't want to speak for the government about what they conceded or agreed to.

[00:07:01] Speaker 02:
I do not think that there was.

[00:07:03] Speaker 00:
Did this case turn on whether or not there was any correlation between seizures and SUDC?

[00:07:10] Speaker 00:
Because that's not the way I understood.

[00:07:12] Speaker 02:
I think the case turns on two things.

[00:07:18] Speaker 02:
Was there a preponderance of evidence that NA suffered a seizure that night?

[00:07:26] Speaker 02:
But I do think that the question of whether there's a correlation between seizures and SUDC is an important part of our medical theory.

[00:07:37] Speaker 02:
And so that case also turned out better.

[00:07:39] Speaker 03:
And it was rejected by the special master, right?

[00:07:43] Speaker 03:
The special master found that you hadn't proved there was a connection between seizures and death.

[00:07:51] Speaker 02:
That's true.

[00:07:52] Speaker 02:
And that's another reason why the

[00:07:54] Speaker 02:
Court of Federal Claims judge aired when he denied the special master an opportunity to consider the Gould article, because the Gould article provides direct evidence that seizures cause SUDC deaths.

[00:08:12] Speaker 02:
They observed on videotapes both the seizures in these children and the respiratory distress that follows seizures.

[00:08:22] Speaker 02:
the sudden unexplained death and epilepsy-like mechanism through which seizures cause death in children with epilepsy and which has been hypothesized to cause death in children with SUDC.

[00:08:38] Speaker 02:
And for the first time, the Gould article describes the actual observation of both the seizures and the respiratory difficulties caused by the seizures.

[00:08:49] Speaker 02:
And so it is very important evidence on the question of whether seizures can cause death.

[00:08:57] Speaker 00:
Well, I guess I don't see how whether or not seizures can cause SUDC is dispositive or

[00:09:08] Speaker 00:
directly relevant to any of the bases upon which the special master relied in her.

[00:09:15] Speaker 00:
I mean, the Gould article doesn't, there's no statistical, there's no like 95% of SUDC cases are caused by seizures.

[00:09:25] Speaker 00:
There's nothing about the numbers, right, in the Gould article.

[00:09:29] Speaker 00:
It's just instances of the fact that seizures can cause SUDC.

[00:09:35] Speaker 00:
Anything beyond that that you can take away from that article?

[00:09:41] Speaker 00:
And I don't know that I understood that it was disputed below that the case turned on whether or not seizures could cause SUDC.

[00:09:54] Speaker 02:
I wish I felt that way.

[00:09:55] Speaker 02:
But I think the government did dispute whether febrile seizures could cause death in a child that didn't have a history of seizures or some other neurologic disorder.

[00:10:06] Speaker 02:
And I think the special master concluded that

[00:10:10] Speaker 02:
That was what she thought the difficult question was.

[00:10:14] Speaker 02:
I may have had more difficulty proving that point than I would have liked, because it seems so obvious to me that seizures can cause death.

[00:10:23] Speaker 02:
They did concede that seizures can cause death in the context of a complex or prolonged seizure, that those are less common than what are sometimes called

[00:10:37] Speaker 02:
simple febrile seizures, which are brief.

[00:10:40] Speaker 00:
But the issue here was whether or not NA had a seizure at all.

[00:10:46] Speaker 00:
And so... Absolutely, there is a... This doesn't go to that question, does it?

[00:10:54] Speaker 00:
Or are you starting backwards and saying, because sometimes seizures can cause SUD,

[00:11:01] Speaker 00:
then that proves that she had a seizure as a result of her vaccine?

[00:11:07] Speaker 00:
Was that the theory?

[00:11:18] Speaker 00:
Sorry, it's a convoluted question.

[00:11:21] Speaker 02:
Yeah, I understand.

[00:11:21] Speaker 02:
I think I understand the question.

[00:11:23] Speaker 02:
And that is, what I'm trying to explain is that

[00:11:28] Speaker 03:
You're saying that unexplained death is evidence of a seizure, right?

[00:11:33] Speaker 03:
That's the theory.

[00:11:37] Speaker 02:
Yes, that's the theory.

[00:11:40] Speaker 02:
And what I'm saying is that the doctors that have studied the question of whether seizures cause SUDC

[00:12:00] Speaker 02:
They looked for, in the record before the special master, was based on some kind of proxy for the observation of the seizure.

[00:12:16] Speaker 02:
One of the proxies had been the anomalies in the hippocampus.

[00:12:21] Speaker 02:
The other proxies had been family or personal history of seizures.

[00:12:29] Speaker 02:
And the Gould article doesn't have to depend upon a proxy.

[00:12:35] Speaker 02:
It's actual observation of seizures and SUDC deaths.

[00:12:40] Speaker 02:
And these were the authors of the Gould article, reviewed seven videos of the last sleep period of children who died SUDC deaths.

[00:12:57] Speaker 02:
These seven videos were all of the videos, usable videos, available from 301 cases of SUDCs studied by the New York University SUDC Research and Research Collaborative.

[00:13:18] Speaker 02:
And so it's not like it's a sample of seven.

[00:13:22] Speaker 02:
It's really a sample of 301.

[00:13:26] Speaker 02:
cases that had that critical, valuable evidence of an actual video.

[00:13:33] Speaker 02:
Most part of those was one of those 301.

[00:13:36] Speaker 02:
But they didn't have a video.

[00:13:38] Speaker 02:
We probably wouldn't be here if they had a video of this last sleep period.

[00:13:46] Speaker 02:
So basically, this group, the SUDC Research and Registry Collaborative,

[00:13:58] Speaker 02:
is one of the premier groups studying the question of whether vaccines cause vaccines, excuse me, whether seizures cause SEDC.

[00:14:07] Speaker 02:
And they looked at this video.

[00:14:10] Speaker 02:
And what I'm saying is that it is now, based on the Gould article,

[00:14:21] Speaker 02:
There's very little question in my mind that that changes the whole landscape of the question of whether seizures cause death and whether seizures cause SCVC death.

[00:14:37] Speaker 02:
And with the observation reported in the Gould article, I would say not an open question anymore.

[00:14:44] Speaker 02:
But it's overwhelmingly proven.

[00:14:48] Speaker 02:
that seizures occur in SUDC deaths.

[00:14:52] Speaker 02:
And that's different.

[00:14:53] Speaker 01:
What is your best evidence, though, that NA specifically suffered a seizure?

[00:15:00] Speaker 02:
Well, the evidence includes the family history.

[00:15:06] Speaker 02:
Her brother had seizures, febrile seizures.

[00:15:10] Speaker 02:
And under circumstances somewhat similar to NA's in that he had, oops, I'm running out of time.

[00:15:19] Speaker 02:
I haven't been very good about that.

[00:15:20] Speaker 02:
Anyway, so family history.

[00:15:27] Speaker 02:
She had a fever or an elevated temperature the night before when she went to bed.

[00:15:33] Speaker 02:
The circumstances of her death were somewhat similar to her brother's seizure in that she was warm because she was given Motrin and then

[00:15:48] Speaker 02:
She died that night.

[00:15:50] Speaker 02:
Her brother's seizures, he was warm.

[00:15:52] Speaker 03:
You're also relying on the government's concession that this vaccine can cause seizures, right?

[00:15:59] Speaker 02:
Oh, absolutely.

[00:16:01] Speaker 02:
This vaccine causes seizures.

[00:16:03] Speaker 02:
And it's important to note that seven to 10 days is the time period in which you would expect a vaccine-caused seizure.

[00:16:12] Speaker 02:
So deaths.

[00:16:16] Speaker 02:
that are associated with seizures at this critical time period is good evidence that there were seizures in her case.

[00:16:29] Speaker 02:
And I apologize for going over my time.

[00:16:31] Speaker 03:
We'll give you two minutes to rebuttal.

[00:16:35] Speaker 03:
Thank you.

[00:16:35] Speaker 03:
Mr. Sacks.

[00:16:47] Speaker 04:
Thank you, Your Honor.

[00:16:48] Speaker 04:
May it please the court?

[00:16:51] Speaker 03:
Let me tell you where I think we are.

[00:16:52] Speaker 03:
If I understand the special master decision, it rests on two conclusions.

[00:16:58] Speaker 03:
One, insufficient evidence that the child suffered a seizure, and two, insufficient evidence that seizures can cause death.

[00:17:08] Speaker 03:
And I think the Gould article is a powerful evidence.

[00:17:13] Speaker 03:
On the second question, it's more

[00:17:16] Speaker 03:
tenuous on the first question as to whether she actually suffered a seizure.

[00:17:22] Speaker 03:
But I wonder, given the special master's familiarity with the record, whether a remand

[00:17:31] Speaker 03:
Under these circumstances, it's appropriate to let the special master reach a decision as to whether the Gould article is significant and should result in reopening the record.

[00:17:40] Speaker 03:
So could you address that question?

[00:17:43] Speaker 04:
Sure, Your Honor.

[00:17:44] Speaker 04:
Well, of course, Judge Brubink had the option to remand, but remand is permissive.

[00:17:49] Speaker 04:
It's not mandatory.

[00:17:50] Speaker 04:
The special master was divested of jurisdiction.

[00:17:53] Speaker 04:
when petitioners filed the motion for review.

[00:17:56] Speaker 04:
They filed the motion before the Court of Federal Claims.

[00:17:58] Speaker 03:
So why not let the special master make the decision as to whether the Gould article has significance on the question of whether she suffered a seizure or not, rather than the Court of Federal Claims, who's less familiar with the record.

[00:18:13] Speaker 04:
Right.

[00:18:13] Speaker 04:
Well, the Court of Federal Claims applied the Van Erve test to whether or not it was supposed to reopen and relied on the findings of the special master to make independent findings that go to causation or entitlement there.

[00:18:27] Speaker 04:
And again, I've just stressed that remand is permissive.

[00:18:30] Speaker 04:
It's not mandatory.

[00:18:31] Speaker 04:
Judge Brink is very well qualified to apply this Van Erve test.

[00:18:35] Speaker 04:
It was his case at the Court of Federal Claims.

[00:18:38] Speaker 04:
And of course, this court would review that determination to the abuse of discretion

[00:18:43] Speaker 04:
standard of review, and whether it was a manifestly erroneous application of the Van Erp test to deny the motion.

[00:18:51] Speaker 04:
And we think that at the end of the day, as I think Your Honor was alluding to in the beginning, first and foremost, the Gould article is not outcome-determinative or effective outcome.

[00:19:01] Speaker 04:
It doesn't speak to whether NA suffered a seizure the night of her death.

[00:19:05] Speaker 03:
His theory is that it does speak to that, because it suggests that unexplained deaths

[00:19:11] Speaker 03:
are linked to seizures, and that suggests, since her death was unexplained, that she had a seizure.

[00:19:18] Speaker 03:
It's a theory.

[00:19:19] Speaker 03:
I don't know how powerful it is.

[00:19:20] Speaker 03:
It's a theory.

[00:19:21] Speaker 04:
Yes, and I think that goes to

[00:19:26] Speaker 04:
strengthening the inference that was discussed earlier, potentially that goes to the out in one prong of causation of whether a seizure can be a cause of death in a sudden case.

[00:19:40] Speaker 04:
But that goes to, again, the theory of causation.

[00:19:43] Speaker 04:
And it doesn't go to the factual predicates of the case and of the causation analysis.

[00:19:48] Speaker 04:
This court can affirm on the narrow basis of affirming the special master's finding that there is not preponderant evidence that

[00:19:56] Speaker 04:
NA suffered a seizure, so.

[00:19:58] Speaker 00:
But explain to me, because I'm forgetting the details of the special master's findings, did at least a leg on the stool of her conclusions rest on the fact that there was not sufficient evidence to establish that seizures caused SUD?

[00:20:14] Speaker 04:
Yeah, well, I think that she went through the Alton analysis.

[00:20:19] Speaker 04:
Can you point me to where it is?

[00:20:21] Speaker 04:
Is it 49 and 50, or I couldn't find right?

[00:20:25] Speaker 04:
So at the beginning of the analysis, we're talking about the two factual predicates, and the primarily important one being whether or not it's preponderant evidence that NA suffered a seizure that set beginning at appendix 49.

[00:20:38] Speaker 04:
After the factual analysis, the causation analysis begins at appendix 51.

[00:20:45] Speaker 04:
And of course, without the factual predicates, the Alton 1 theory of causation necessarily fails.

[00:20:53] Speaker 04:
But the special master put that aside and gave independent reasons for why the theory in general doesn't meet the preponderance standard.

[00:21:04] Speaker 04:
And she has several independent factors for that, again, beginning at appendix 51.

[00:21:12] Speaker 04:
Funding was based on multiple grounds.

[00:21:14] Speaker 04:
The absence of clinical history or physical evidence of a seizure.

[00:21:17] Speaker 04:
The autopsy pathologist and the neuropathologist, who's part of the SUDEC team, did not find evidence of a seizure.

[00:21:27] Speaker 04:
agreed that it would be a low-grade fever at most and that insufficient to produce the seizure, as well as treated with antipyretics, Motrin, which would have been working at the time.

[00:21:38] Speaker 04:
And then the special master's rejection of both the petitioner's expert's opinions as either unsupported or outweighed by those from the government.

[00:21:56] Speaker 03:
Well, the fact that the vaccine causes seizures is some evidence that she had a seizure, right?

[00:22:05] Speaker 03:
Maybe not sufficient, but it's some evidence.

[00:22:10] Speaker 04:
The theory of causation is that the MMRV caused a febrile seizure, a first-time fatal febrile seizure, and also in a vulnerable child.

[00:22:18] Speaker 04:
And that was part of the theory that was litigated below, is that NA had brain abnormalities that predisposed her.

[00:22:26] Speaker 03:
Your stipulation wasn't limited to children with brain abnormalities.

[00:22:30] Speaker 03:
It was just a straight-out stipulation that this vaccine can cause seizures.

[00:22:37] Speaker 03:
Can cause febrile seizures, correct.

[00:22:40] Speaker 04:
But it was not stipulated it could cause fatal febrile seizures, Your Honor.

[00:22:47] Speaker 00:
Well, looking at the first paragraph, I'm trying to find something that relates to whether this information was cumulative or what she did with the theory.

[00:22:55] Speaker 00:
The best I'm coming up with right now is the top of Appendix 53, she refers to Dr. Kinsberg, testified that unobserved seizures undoubtedly occur and can cause death.

[00:23:11] Speaker 00:
So this is talking about, because the Gould article is about seizures causing SUGC, not about the vaccine causing seizures.

[00:23:21] Speaker 00:
There's no mention of the vaccine.

[00:23:22] Speaker 00:
And on that point, she said, as the medical literature aptly establishes an increased risk of having a seizure, when the likelihood is still very low, does not rise.

[00:23:34] Speaker 00:
Yeah, I'm not sure I can find exactly what she said about

[00:23:40] Speaker 00:
how much to the extent to which she relied on whether or not seizures can cause SUDC.

[00:23:49] Speaker 00:
In your recollection, did she accept Dr. Kinsborne's testimony that seizures can occur and can cause death?

[00:24:02] Speaker 04:
No, they accepted the concept that unobserved seizures can occur, but that would go again to the theory of causation.

[00:24:09] Speaker 04:
And we do think that the school article, while relevant, is cumulative of the evidence that was submitted in this case that's discussed at length in the special master's decision that's submitted in support of the theory that a

[00:24:23] Speaker 04:
One way in which a sudden explained death in Chao can occur is a seizure.

[00:24:30] Speaker 04:
That's what the Gould article purportedly shows.

[00:24:33] Speaker 03:
But it contradicts one of her grounds, right?

[00:24:37] Speaker 03:
Which was that there wasn't sufficient evidence that seizures can cause death.

[00:24:42] Speaker 04:
I would respectfully not agree that it contradicts.

[00:24:45] Speaker 04:
I think it strengthens petitioners out than when showing.

[00:24:49] Speaker 04:
But there are other factors of the overall theory of causation that it doesn't speak to.

[00:24:53] Speaker 04:
Again, febrile seizure, there's no link to vaccines, the predisposed nature that was argued by petitioners experts that NA had.

[00:25:08] Speaker 04:
Again, it is relevant and it might help towards the theory of causation under ALFIN, but this court doesn't need to get there because it's not outcome determinative in the sense that it doesn't speak to the factual predicate that NA did not suffer a seizure.

[00:25:23] Speaker 04:
This study does not provide, does not affect that outcome.

[00:25:26] Speaker 04:
And without that outcome, it does not need to reach the ALFIN causation.

[00:25:30] Speaker 03:
Under the relevant test, it doesn't have to be outcome determinative, does it?

[00:25:35] Speaker 04:
I believe it does.

[00:25:36] Speaker 04:
Relevant and effective of outcome is the first feature.

[00:25:39] Speaker 04:
It's the paramount feature.

[00:25:41] Speaker 04:
And elsewhere in that decision in Van Erve, it is outcome-determinative.

[00:25:46] Speaker 04:
And my review of the special master's decisions that have applied this case in this test below supports that it is outcome-determinative.

[00:25:56] Speaker 04:
It's a high bar.

[00:25:57] Speaker 04:
And we think that makes sense.

[00:26:00] Speaker 04:
There's importance and finality in these cases.

[00:26:02] Speaker 04:
This case has been litigated for years

[00:26:05] Speaker 04:
have been several rounds of expert reports from five experts, pre-hearing briefing, a multi-day hearing, now a lengthy over 50 page decision, and new evidence is the nature of this program in science in general.

[00:26:20] Speaker 04:
Studies come out all the time and if we were to allow

[00:26:22] Speaker 03:
I understand that it would be a big deal to reopen the record and start having additional evidence about the significance of the Gould article and so on and so forth.

[00:26:34] Speaker 03:
But that doesn't seem to me to speak to the question of who should make the decision as to whether the record should be reopened, whether it should be the court of federal claims making that decision or the special master who has the greater familiarity with the record.

[00:26:47] Speaker 03:
In other words, why not let the special master make a determination

[00:26:51] Speaker 03:
as to whether the Gould article has enough significance to warrant reopening the record.

[00:26:56] Speaker 04:
Well, again, I think that was an option, although I would say logistically, procedurally, I'm not sure how that would have worked.

[00:27:04] Speaker 04:
It might have been messy with a pending motion for review and a separate motion for leave to file new evidence.

[00:27:10] Speaker 04:
what the judge would have done in terms of remanding that back.

[00:27:13] Speaker 03:
It would have paused the appeal and given the special master the authority to consider a motion to reopen the record based on the Gould article.

[00:27:24] Speaker 03:
Sure.

[00:27:24] Speaker 04:
But again, respectfully, I think this court just has to look at that

[00:27:28] Speaker 04:
decision that the Court of Federal Claims made from the abuse of discretion standard of review and whether it was manifestly erroneous whether Judge Brubing misunderstood and misapplied this Van Erf test to that it's been formulated for deciding these essentially motions to reopen the record and we don't think that upon applying that standard of review that there was any error here.

[00:27:59] Speaker 01:
What would be the best part of the special master's decision that you would point to on the cumulative question that Judge Pross raised?

[00:28:07] Speaker 01:
Is there a certain part you'd point to that basically makes school cumulative of what was already in the record and considered by the special master?

[00:28:15] Speaker 04:
Well, Your Honor, I think that all of the articles that are discussed in the factual background section of this decision, again, are submitted for the same purpose,

[00:28:28] Speaker 04:
support the theory that it's a febrile seizure or a fatal seizure can be a cause of death and aesthetic.

[00:28:40] Speaker 04:
In terms of the analysis, if you're asking me,

[00:29:01] Speaker 04:
I think we could look at the appendix 53 into 54 and the petitioner's theory that relied in part on analogizing SUDEP, S-U-D-E-C, to SUDEP, S-U-D-E-P, and the literature there trying to make the connection between

[00:29:25] Speaker 04:
The pathophysiology which leads to fatal seizures in children with epilepsy and and extrapolating that to to suddock Again, I think all the articles that are discussed in the decision prior not in the analysis, but in the decision All speak to the same the same offering of gold so hefty and Kinney at appendix

[00:29:53] Speaker 04:
beginning at appendix 16 through appendix 19, it's a long discussion of several articles, Kinney, Hefty, Kahn, all these articles that were submitted to support the inference that the petitioners are asking the court to make.

[00:30:17] Speaker 04:
So I think it's- This is the first time there was direct evidence that seizures could cause death, right?

[00:30:23] Speaker 04:
There's direct video evidence in the Gould article, yes.

[00:30:30] Speaker 04:
And again, this theory is a febrile seizure.

[00:30:32] Speaker 04:
I believe there are two cases of febrile seizure out of the six.

[00:30:35] Speaker 04:
And also, I'll point out that there are varying video qualities to these studies as well.

[00:30:41] Speaker 04:
And in the two cases of febrile seizures, there were confirmed concurrent illnesses that would explain the fevers.

[00:31:00] Speaker 04:
OK, anything else?

[00:31:01] Speaker 04:
No, thank you.

[00:31:01] Speaker 04:
I would just say because the special master's findings were thoroughly reasoned and not implausible, and the Court of Federal Claims correctly applied the law, the judgment should be affirmed.

[00:31:10] Speaker 04:
Thank you.

[00:31:11] Speaker 03:
Thank you.

[00:31:12] Speaker 03:
Mr. Webb, you have two minutes.

[00:31:34] Speaker 02:
I want to address first the question, who should decide whether this article was or could become a determinative?

[00:31:46] Speaker 02:
I think it's clear that the special master is best suited for making that decision.

[00:31:53] Speaker 02:
And I think the case law doesn't tell us exactly how high the bar is about how

[00:32:05] Speaker 02:
important the evidence must be or should be before it should be admitted.

[00:32:12] Speaker 02:
I think that the right standard should be whether it maybe could change the outcome or very likely to change the outcome.

[00:32:23] Speaker 02:
I don't think that's defined in the Van Erve test or any of the cases that have applied the Van Erve test.

[00:32:31] Speaker 02:
But in this compensation program,

[00:32:33] Speaker 02:
it is appropriate to consider all the available evidence.

[00:32:38] Speaker 02:
And I don't think anyone can argue that Gould isn't important evidence on the questions.

[00:32:44] Speaker 02:
Both the questions are whether it was a seizure and the question of whether seizures caused death in the SCDC.

[00:32:52] Speaker 02:
I want to touch real quickly on a couple of things.

[00:32:54] Speaker 02:
One, the authors of the Gould article believed all those seizures were febrile seizures.

[00:33:01] Speaker 02:
Fever was observed before the child's last sleep period in only two cases.

[00:33:08] Speaker 02:
But the implication of the authors is that these seizures are believed to be febrile seizures, because fever is what triggers seizures in children this age.

[00:33:21] Speaker 02:
If they don't have epilepsy, something triggers seizures.

[00:33:30] Speaker 02:
All the children in Gould.

[00:33:35] Speaker 02:
The author said they couldn't have said there was a seizure in the absence of the videotape.

[00:33:42] Speaker 02:
That's the problem here.

[00:33:44] Speaker 02:
Unwitnessed seizures cause SUDC, some cases of SUDC.

[00:33:49] Speaker 02:
And Gould is the first time those seizures have been observed.

[00:33:54] Speaker 02:
And those seizures were observed in the context of also causing death through the respiratory suppression scene and sudden unexplained death in epilepsy.

[00:34:05] Speaker 02:
Thank you for your time.

[00:34:07] Speaker 03:
OK.

[00:34:07] Speaker 03:
Thank you.

[00:34:07] Speaker 03:
I think both counsel cases submitted.