[00:00:00] Speaker 02:
The next case for argument is 24-1663, Asenbach versus HHS.

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

[00:00:07] Speaker 02:
Chen Chaplin, when you're ready.

[00:00:10] Speaker 01:
Thank you, Your Honor.

[00:00:13] Speaker 01:
Your Honors, may it please the court.

[00:00:15] Speaker 01:
This case involves an injury that occurred under the National Vaccine Compensation Act.

[00:00:20] Speaker 01:
And this act was enacted by Congress

[00:00:27] Speaker 01:
award damages that can occur from vaccines.

[00:00:31] Speaker 01:
In this particular case, this child had a pre-existing seizure disorder at four months, which was recognized to have been caused by a vaccine the prior day.

[00:00:42] Speaker 01:
He continued to have additional seizures, too, but was considered developmentally normal.

[00:00:49] Speaker 01:
Approximately in April of 2013, he received a fourth vaccination.

[00:00:55] Speaker 01:
Within 24 hours, he developed a 30-minute seizure disorder.

[00:00:59] Speaker 01:
And when that didn't abate with drugs that the mom gave, the EMTs also administered an anti-seizure medication.

[00:01:11] Speaker 01:
And the child then proceeded to arrest and suffered eight minutes of hypoxia, or low oxygenation.

[00:01:21] Speaker 01:
The special master denied compensation.

[00:01:25] Speaker 01:
he indicated that he would have found that the child's pre-existing disorder had worsened after the seizure administration, which would be Loving's Prong 1-3, which requires an evaluation of the child's condition before and after the vaccine, and to determine whether or not the vaccine worsened or determined

[00:01:50] Speaker 01:
whether the condition was worse after the vaccine.

[00:01:53] Speaker 01:
He acknowledged that if he had engaged in this analysis, he would have found for petitioners for prongs 1 through 3.

[00:02:01] Speaker 01:
He found that prongs 4 through 6, which is essentially the outland prongs utilized to evaluate vaccine injuries, was insufficient.

[00:02:14] Speaker 01:
Specifically, he indicated that the petitioner's theory

[00:02:18] Speaker 01:
was deficient because it assumes that the one-time effect of stimulating cytokines will in turn contribute to a pathogenic process.

[00:02:30] Speaker 01:
He acknowledged that the petition's theory was plausible.

[00:02:36] Speaker 01:
What he failed to do, however, was take into account the testimony by petitioners expert of the fact that not only was it just cytokine activation from the vaccination,

[00:02:48] Speaker 01:
but also the hypoxia or the lack of oxygenation that contributed to this child's subsequent deterioration.

[00:02:57] Speaker 04:
Do you agree that you need to win on prongs four and five in order to prevail on the appeal?

[00:03:03] Speaker 01:
Prong four requires petitioners to provide a theory as to how vaccination can cause us harm.

[00:03:10] Speaker 01:
Prong five is a logical sequence of cause and effect on how this

[00:03:17] Speaker 01:
of vaccination caused the harm.

[00:03:19] Speaker 01:
Historically, the theories have been provided by expert testimony.

[00:03:25] Speaker 01:
And on Prong 5, they've looked to treating physicians.

[00:03:30] Speaker 01:
So tell me a question, though.

[00:03:31] Speaker 04:
And I appreciate your explanation of the prongs.

[00:03:33] Speaker 04:
But do you agree that you need to win on those prongs in order to win on the appeal?

[00:03:38] Speaker 01:
I'm sorry.

[00:03:38] Speaker 01:
So I shall answer your question.

[00:03:40] Speaker 04:
Do you agree that you would need to win on those prongs?

[00:03:43] Speaker 04:
We were just discussing.

[00:03:44] Speaker 04:
You were giving me a little summary explanation of them.

[00:03:47] Speaker 04:
in order to prevail on this appeal.

[00:03:50] Speaker 01:
Yes, I would.

[00:03:52] Speaker 01:
However, what the petitioner is claiming, asserting, is that the special master did not consider all the evidence that was placed into the record on prong four and prong five.

[00:04:05] Speaker 01:
And not only that, he required direct evidence.

[00:04:09] Speaker 01:
We're permitted to prove our cases by circumstantial evidence.

[00:04:13] Speaker 01:
And when he required the direct evidence, what he specifically was looking for was an MRI which reflected brain damage.

[00:04:22] Speaker 01:
Now, in this child's particular case, after sustaining the prolonged seizure, he did have an MRI which was performed, which was negative.

[00:04:30] Speaker 01:
And the petitionist expert explained that in 30% cases, MRIs are negative.

[00:04:38] Speaker 01:
And he provided a reasoning for that in an article that he submitted.

[00:04:42] Speaker 01:
And in that article, it indicated that if the damage is anatomical, it will be reflected on the MRI.

[00:04:53] Speaker 01:
However, if the damage is functional, it will not be reflected.

[00:04:59] Speaker 01:
And the special master failed to credit that information as well.

[00:05:03] Speaker 01:
And he failed to credit the submission of this article.

[00:05:10] Speaker 01:
Now, the other thing under prong four, which petitioners assert was erroneous, is that in denying compensation, the special master required petitioners to prove

[00:05:28] Speaker 01:
that the vaccine wholly altered the cost of his genetic mutation.

[00:05:34] Speaker 01:
Now, this genetic mutation was a variant of uncertain significance and was thought that it may affect splicing.

[00:05:46] Speaker 01:
Variants of uncertain significance indicate that no one else in the world has this mutation.

[00:05:53] Speaker 01:
So if no one else in the world has this mutation, it is impossible for a petitioner to predict the outcome of what this mutation will produce.

[00:06:06] Speaker 01:
What is known is that in SCN1 mutations, there is a spectrum of disorder.

[00:06:13] Speaker 01:
The person can be totally asymptomatic to being totally disabled.

[00:06:19] Speaker 01:
And in the absence of any functional studies, which were not performed here,

[00:06:24] Speaker 01:
It is unknown whether this mutation is pathogenic or not.

[00:06:28] Speaker 01:
Special master acknowledged the findings here, but yet ruled that because we have failed to show that this vaccine wholly altered this child's underlying condition, that we have failed.

[00:06:44] Speaker 01:
He was not entitled to compensation.

[00:06:50] Speaker 01:
Petitioners said that is not their burden of proof.

[00:06:54] Speaker 01:
What is required is that they show a change in condition from the child's baseline after administration of the vaccination.

[00:07:08] Speaker 01:
If the special master's conclusion was accepted, it would indicate that in any child who had a genetic disorder,

[00:07:21] Speaker 01:
that unless you rule out the genetic disorder, they cannot be awarded compensation.

[00:07:27] Speaker 01:
And that's not what Congress intended when it passed this act.

[00:07:33] Speaker 01:
It was intended to be generous and fair.

[00:07:37] Speaker 01:
And in close cases, they were to rule in favor of petitioner.

[00:07:44] Speaker 01:
Here, where the child has

[00:07:48] Speaker 01:
a variant of uncertain significance where it is unknown what the future course may be, no one else has this mutation, it would be impossible for a petition to provide any evidence about what could be expected from this condition.

[00:08:08] Speaker 04:
Is your primary argument an argument that the special master got the weighing of the evidence wrong?

[00:08:16] Speaker 01:
imposed a higher burden of proof than that required by the act.

[00:08:22] Speaker 01:
He required information that, in this court previous indicated, was to provide a theory.

[00:08:33] Speaker 04:
Can you point me to a specific appendix page where you're saying the special master did

[00:08:40] Speaker 04:
this in terms of you said there was a higher burden required.

[00:08:44] Speaker 04:
Can you point me to somewhere in the record where I can see the alleged error made by the special master that you're continuing?

[00:08:52] Speaker 01:
The alleged error, Your Honor, is in the criteria that he imposed on petitioners to establish the fourth prong of loving, which is a theory.

[00:09:08] Speaker 01:
And the theory

[00:09:10] Speaker 01:
does not require petitioners to exclude a pre-existing disorder.

[00:09:21] Speaker 01:
Once they have established that entitlement, then the burden then shifts to the respondent to show that the genetic disorder would have been the sole cause, that it was more likely than not that the genetic disorder

[00:09:39] Speaker 01:
caused the harm.

[00:09:41] Speaker 01:
In this particular case, he imposed that burden on petitioners, and that is erroneous.

[00:09:52] Speaker 01:
In addition, petitioners alleged that the special master imposed a requirement on Prong 5

[00:10:04] Speaker 01:
which is for petitioners to prove a logical sequence of cause and effect.

[00:10:10] Speaker 01:
And he indicated that we had not proven Prong 5 because there was no contemporaneous records which attributed the deterioration to vaccines, which is an indication that he sought direct evidence again.

[00:10:28] Speaker 01:
we are permitted to prove these cases by circumstantial evidence.

[00:10:33] Speaker 01:
And what this circumstantial evidence indicated was that after suffering the prolonged seizure of greater than 30 minutes with hypoxia of approximately eight minutes, the child was subsequently intubated for respiratory distress and respiratory support.

[00:10:53] Speaker 01:
He was placed on a ventilator, and after he was stabilized,

[00:10:58] Speaker 01:
several days later, was sent home.

[00:11:01] Speaker 01:
He was evaluated by his neurologist at Duke, who heard no vocalizations.

[00:11:14] Speaker 01:
Several weeks later, he was seen by his family practitioner, his pediatrician, who indicated that the parents were concerned about the child's speech and his toe walking.

[00:11:27] Speaker 01:
And approximately a month later, he was evaluated by his pediatric neurologist, who indicated that the child needed developmental services.

[00:11:37] Speaker 01:
Now, prior to the April 2013 administration of vaccines, despite having a seizure disorder, he was considered developmentally normal.

[00:11:52] Speaker 01:
Only after he suffered the prolonged seizure with the hypoxia

[00:11:56] Speaker 01:
were these developmental concerns apparent?

[00:12:04] Speaker 01:
And while not direct evidence, it is circumstantial evidence that injury did occur here.

[00:12:14] Speaker 01:
So that would suffice establishment of prong five, which is the logical sequence of cause and effect.

[00:12:24] Speaker 02:
Council, you're into your rebuttal time.

[00:12:27] Speaker 02:
Do you want to save it?

[00:12:28] Speaker 02:
Pardon me?

[00:12:28] Speaker 02:
You're into your rebuttal time.

[00:12:30] Speaker 02:
Would you like to save the remainder of it?

[00:12:32] Speaker 02:
Yes, I would.

[00:12:33] Speaker 02:
Okay.

[00:12:34] Speaker 02:
Let's hear from the government.

[00:12:36] Speaker 02:
Okay.

[00:12:45] Speaker 03:
Thank you.

[00:12:45] Speaker 03:
Good morning and may it please the court.

[00:12:46] Speaker 03:
My name is Felicia Langell for the secretary of HHS.

[00:12:51] Speaker 03:
Petitioners argue that this case is so distinguishable from other comparable cases that, unlike all of those prior cases of SCN1A gene mutation and epilepsy, that this case is deserving of compensation.

[00:13:03] Speaker 03:
It is not.

[00:13:05] Speaker 03:
The Chief Special Master reviewed the evidence in its entirety, and his findings were supported by plausible inferences and a rational basis.

[00:13:12] Speaker 03:
The Chief Special Master committed no legal error in his analysis of the evidence.

[00:13:16] Speaker 03:
The Court of Federal Claims affirmed the Chief Special Master's denial of entitlement and properly refused to reweigh the evidence.

[00:13:23] Speaker 00:
Was the special master correct in saying that the test is that something has to wholly alter the course of the disease?

[00:13:38] Speaker 03:
Well, Your Honor, what petitioners

[00:13:43] Speaker 03:
Well, okay, so let's take a step back.

[00:13:45] Speaker 03:
So what the Chief Special Master... Okay.

[00:13:53] Speaker 02:
Can you just remind us, this is just, I know we're talking about it in terms of loving now instead of Alton, but this step is Alton one, right?

[00:14:02] Speaker 02:
Yes, loving, prom, four.

[00:14:04] Speaker 02:
What's the established standard to show Alton one or loving four?

[00:14:11] Speaker 02:
There's a term, there's a phrase, what is it?

[00:14:15] Speaker 03:
You mean the preponderance evidence standard?

[00:14:17] Speaker 02:
The preponderance evidence of what?

[00:14:19] Speaker 03:
Oh, that the vaccine can cause

[00:14:23] Speaker 03:
in this case, significant aggravation of the child's epilepsy.

[00:14:29] Speaker 02:
This is where they have to have a plausible medical theory that propounded evidence of a plausible medical theory that it caused it?

[00:14:37] Speaker 03:
Propounded evidence of a medical theory that caused it.

[00:14:41] Speaker 03:
Right.

[00:14:41] Speaker 03:
Right.

[00:14:42] Speaker 03:
So, Your Honor, let me, if I may, go back to.

[00:14:45] Speaker 02:
Yeah, go back to the question and explain how.

[00:14:49] Speaker 02:
the standard that appears to be articulated here, that it wholly alters, or it's but four, matches up with the standard you just articulated, because it sounds like a much higher standard.

[00:15:02] Speaker 03:
So in this case, it's important to explain that what this child has is, and she's supposed to ask her after reviewing all the evidence,

[00:15:15] Speaker 03:
determined the proponent evidence shows that this child suffers from a condition known as Dravet syndrome.

[00:15:22] Speaker 03:
Dravet syndrome is a genetic epilepsy that is refractory to treatment and begins in the first year of life.

[00:15:31] Speaker 03:
Now, in addition to that, this child has a genetic defect to his SCN1A gene.

[00:15:38] Speaker 03:
And SCN1A genes are known to be causal of Dravet syndrome.

[00:15:46] Speaker 03:
So what petitioners take exception to and keeping in mind that this is a chronic condition, this child was born with this condition and over the course of time this condition progresses and goes through a natural course of change as the child develops.

[00:16:05] Speaker 03:
What petitioners are taking exception to is that the chief special master looked at that, looked at the natural course progression of this disorder.

[00:16:16] Speaker 03:
And what they're saying is that in Sharp, the case that this court decided in Sharp, that petitioners are not.

[00:16:24] Speaker 02:
I understand all of this, but isn't the problem that

[00:16:29] Speaker 02:
I have a hard time understanding if the special master understood and you know, he probably does because we've been around for a long time and we have to base our decision on what he wrote and he wrote

[00:16:43] Speaker 02:
This does not mean that the impact of the vaccine on a person with Dravet, you say it's Dravet, more likely than not wholly alters the course of their disease.

[00:16:53] Speaker 02:
That's not, if that's the standard he's applying, that's not the right standard, is it?

[00:16:57] Speaker 02:
The standard is more likely than not aggravates the course of their disease, because this is an aggravation case.

[00:17:05] Speaker 02:
It doesn't have to show wholly alteration.

[00:17:08] Speaker 02:
It has to show aggravation.

[00:17:10] Speaker 02:
And those two things seem to be different.

[00:17:14] Speaker 03:
Well, what this court said in Sharp, it reaffirmed its decision in stone that the special master may consider all evidence in the record, including evidence of other possible sources of injury.

[00:17:29] Speaker 03:
In Sharp, what the special master may not do, and I'm quoting here from Sharp at 1082,

[00:17:36] Speaker 03:
The special master may not place the burden on the petitioner to prove that her significantly aggravated condition was not caused by her gene mutation.

[00:17:45] Speaker 03:
That's not what the chief special master did.

[00:17:47] Speaker 03:
The special master, according to Sharp, may consider evidence of other possible sources of injury offered by a respondent to rebut petitioner's prima facie case.

[00:17:59] Speaker 04:
So what's your best case support for saying that it was fine for the special master to use the phraseology that Judge Hughes just walked you through with respect to the holy altar?

[00:18:10] Speaker 03:
Well, holy altar, Your Honor, holy altar is essentially a restatement of what petitioner is arguing here.

[00:18:18] Speaker 03:
Petitioners are arguing.

[00:18:20] Speaker 03:
Altar means change.

[00:18:22] Speaker 03:
And wholly means if you can apply that to significant change.

[00:18:27] Speaker 03:
So what they're arguing is that those 12-month vaccinations significantly aggravated.

[00:18:33] Speaker 02:
The problem is it's a little more than significant.

[00:18:35] Speaker 02:
It means it completely alters the course.

[00:18:40] Speaker 02:
And that's not their burden to show that it completely alters.

[00:18:43] Speaker 02:
That sounds to me like it's putting a burden on them to show that the

[00:18:50] Speaker 02:
the genetic condition coupled by the vaccination is the answer to why this condition is occurring.

[00:18:58] Speaker 02:
And that's not our precedent, right?

[00:18:59] Speaker 02:
You agree with that.

[00:19:00] Speaker 02:
I think you just said that.

[00:19:02] Speaker 02:
They have to provide a plausible medical theory by a preponderance of the evidence.

[00:19:09] Speaker 02:
Not certain, 100% true, plausible.

[00:19:13] Speaker 02:
And I have a hard time squaring this language with that standard of proof for them.

[00:19:19] Speaker 03:
So your honor, if I'm understanding, what you're saying is this is a matter of degree, that holy is worse than significant, and that the chief special master... I mean, it is.

[00:19:33] Speaker 02:
It's the English language.

[00:19:34] Speaker 02:
I don't mean to be flip, but it means something different.

[00:19:38] Speaker 02:
And maybe this is just in artful opinion writing by this special master.

[00:19:43] Speaker 02:
But the problem we have is we can't get in his head and understand what he thought he was doing.

[00:19:51] Speaker 02:
We have to read his opinion and his opinion looks like it's articulating a higher standard.

[00:19:56] Speaker 03:
Well, Respondent's interpretation of what Chief Special Master is saying is that, in fact, Respondent provided that evidence of that natural course of how Dravet evolves over time.

[00:20:09] Speaker 03:
The burden was placed on Respondent, in fact, not on Petitioner.

[00:20:14] Speaker 03:
If you recall also after

[00:20:16] Speaker 03:
The Chief Special Master found that petitioners had not met their prima facie case of proving causation, either general or specific, loving's prong four or five.

[00:20:26] Speaker 02:
Do you want to talk about five?

[00:20:27] Speaker 02:
Because my understanding is, even if we think that there's legal error on prong four, you still win if there's substantial evidence on prong five.

[00:20:36] Speaker 02:
Exactly.

[00:20:37] Speaker 02:
So, yes, Your Honor.

[00:20:40] Speaker 02:
And can you specifically respond to your opposing council's discussions about

[00:20:47] Speaker 02:
her view that the Special Master required direct evidence and just disregarded the circumstantial evidence of the factual chain of events here?

[00:20:57] Speaker 03:
Yes, Your Honor.

[00:20:58] Speaker 03:
So Petitioner's medical expert posited a theory of causation under that prong for.

[00:21:05] Speaker 03:
And that theory of causation ends with brain hypoxia.

[00:21:10] Speaker 03:
That's Petitioner's theory that this child suffered brain damage due to hypoxia.

[00:21:18] Speaker 03:
Under prong five, petitioners have to show preponderant evidence to support that theory.

[00:21:26] Speaker 03:
They provided no evidence to support that theory.

[00:21:31] Speaker 03:
This is based on the Chief Special Master's review of the record.

[00:21:35] Speaker 03:
First thing is regarding hypoxia.

[00:21:38] Speaker 03:
And I realize that Petitioner's Council talks about direct proof

[00:21:44] Speaker 03:
I will discuss that, but then we'll go to the circumstantial evidence.

[00:21:48] Speaker 03:
But as far as direct proof goes, when this child was admitted into the hospital soon after those 12-month vaccinations, a number of tests were run.

[00:21:55] Speaker 03:
One is the MRI.

[00:21:58] Speaker 03:
The MRI was completely normal.

[00:22:00] Speaker 03:
If there were evidence of hypoxia, it would show up on the MRI.

[00:22:05] Speaker 03:
While a petitioner's expert provided medical literature that said that may not always be the case, again, the standard is preponderant evidence.

[00:22:15] Speaker 03:
And here we have an MRI that is negative.

[00:22:18] Speaker 03:
Additionally, there was blood work done.

[00:22:19] Speaker 03:
There was no evidence of neuroinflammation on the blood work or autoimmune disease.

[00:22:25] Speaker 03:
So as far as all that workup within a couple of days of

[00:22:29] Speaker 03:
of this child's seizures, they were all negative.

[00:22:34] Speaker 03:
So now what petitioners are pointing to is circumstantial evidence.

[00:22:38] Speaker 03:
Soon after this 12-month incident, the child began to demonstrate evidence of developmental delay.

[00:22:48] Speaker 03:
And what they're arguing is, well, that is the circumstantial proof of brain hypoxia, of brain injury, what the chief special master explained after having reviewed all of the evidence in this case, and really as part of the factor unrelated analysis that he did.

[00:23:08] Speaker 03:
is that the way the Dravet syndrome proceeds over time, it starts before a child's first year.

[00:23:17] Speaker 03:
It starts usually at age four to six months is when the seizures begin.

[00:23:22] Speaker 03:
They get progressively worse over time.

[00:23:25] Speaker 03:
And by the time a child reaches age one, that's when you start to see evidence of developmental delay.

[00:23:31] Speaker 03:
And the seizures are increasing in frequency and severity, and you see the developmental delay until the child reaches about age five, which is like a stabilization period.

[00:23:42] Speaker 03:
So that's what he was pointing to.

[00:23:45] Speaker 03:
And his finding, based on the evidence, based on what we know about Trevay syndrome, is

[00:23:52] Speaker 03:
It makes sense that this child would have developmental difficulties around the age of 12 months, which is when we start to see that.

[00:24:02] Speaker 04:
Are you contending then that the special master did consider the circumstantial evidence, but just didn't find that it led to the result that the appellate wanted here?

[00:24:15] Speaker 04:
Is that what you're continuing at a higher level?

[00:24:18] Speaker 03:
Essentially, Your Honor, the Special Master says on page 42 of his decision that he considered that circumstantial evidence, but he was not persuaded by it.

[00:24:27] Speaker 03:
He gave it lesser weight because, again, it is consistent with the natural course of Gervais syndrome.

[00:24:40] Speaker 03:
So that addresses specific causation, unless you have any questions about that.

[00:24:48] Speaker 03:
In addition to, and I'll just basically close unless you have any more questions, but in addition to not finding causation, while the special master found that petitioners had not met their prima facie case, he also did, he didn't have to, but he did a factor unrelated analysis and determined that respondent had met his burden there.

[00:25:18] Speaker 03:
Thank you.

[00:25:19] Speaker 03:
OK, thank you.

[00:25:26] Speaker 01:
Just a few points, Your Honor.

[00:25:29] Speaker 01:
First of all, this child was not diagnosed with Gervais syndrome prior to the onset of status epilepticus and hypoxia.

[00:25:36] Speaker 01:
He was considered developmentally normal.

[00:25:39] Speaker 01:
His physicians actually never diagnosed him with Gervais syndrome.

[00:25:44] Speaker 01:
his physician at Duke actually gave him medications that were contraindicated if he had Gervais syndrome.

[00:25:53] Speaker 01:
Now, it's only after the fact that respondents expert indicates that he suffers from Gervais syndrome based on the clinical course that evolved after he had suffered his prolonged seizure.

[00:26:12] Speaker 01:
after the immunization and after the hypoxia.

[00:26:17] Speaker 01:
The other instance is this variant of uncertain significance.

[00:26:26] Speaker 01:
Nobody else in the world has it.

[00:26:29] Speaker 01:
And the articles that were submitted by respondent experts indicate that variants of uncertain significance should not be utilized in clinical practice.

[00:26:38] Speaker 01:
If it shouldn't be utilized in clinical practice,

[00:26:41] Speaker 01:
It shouldn't be utilized in a court of law.

[00:26:45] Speaker 01:
And secondly, because it's a splice site, it may affect splicing, as it states in the report.

[00:26:56] Speaker 01:
The article submitted by Respondent indicates that splice site mutations are predicted to have no effect or no effect.

[00:27:09] Speaker 01:
The special master did not comment on this evidence in the least bit and failed to address it.

[00:27:16] Speaker 01:
And if he had, petitioners assert that he would not have found that the Chaffetz suffrage or Bay syndrome, and also that it more probably than not occurred because of his SCM1A variant.

[00:27:34] Speaker 01:
SCN1A patients encompass a wide spectrum of disorders, from totally asymptomatic to Gervais, which is a very severe serious disorder.

[00:27:46] Speaker 01:
In this case, with the variant being non-pathogenic, it is impossible to make any determination as to the effect of this variant.

[00:27:55] Speaker 01:
But if the literature submitted by respondents to have any effect whatsoever, it's predicted to have no effect.

[00:28:03] Speaker 01:
Thank you.

[00:28:06] Speaker 02:
Cases submitted.