[00:00:29] Speaker 04:
All right, our next case for today is 2019-1951 Sharp versus HHS.

[00:01:12] Speaker 04:
All right.

[00:01:14] Speaker 04:
Mr. Webb, please proceed.

[00:01:24] Speaker 01:
Thank you.

[00:01:24] Speaker 01:
May it please the court.

[00:01:27] Speaker 01:
I'd like to begin by addressing Sharp's vaccine entry table claim.

[00:01:34] Speaker 01:
The first point I want to make here is that the definition of encephalopathy

[00:01:38] Speaker 01:
and the qualifications and aids to interpretation cannot be rationally applied to define a pre-vaccination encephalopathy.

[00:01:49] Speaker 02:
Do I understand right that the Court of Federal Claims, at least on the non-table claim, didn't rely on the pre-vaccine portion of the analysis, but only on the post-vaccine portion, and said that the QAI

[00:02:08] Speaker 02:
does apply to that, and there wasn't evidence of the required QAI symptoms within the 72 hours.

[00:02:18] Speaker 02:
So that whenever one thinks about the pre-vaccine, you haven't succeeded on the table portion of the analysis just for that reason.

[00:02:31] Speaker 01:
You're exactly right.

[00:02:32] Speaker 01:
That's exactly what the Court of Federal Claims held.

[00:02:35] Speaker 01:
And that was the Court of Federal Claims error.

[00:02:39] Speaker 01:
Because the vaccine injury table, the structure of the table makes it clear that what a petitioner must prove in a significant aggravation case is not that the individual suffered the condition defined in the table

[00:02:59] Speaker 01:
after vaccination, but that the petitioner must show that he suffered a significant aggravation of the pre-existing condition after the vaccination.

[00:03:16] Speaker 01:
And the Vaccine Act does define significant aggravation.

[00:03:21] Speaker 01:
And that is any change for the worse in the pre-existing condition

[00:03:27] Speaker 01:
which results in markedly greater disability, pain, another term, accompanied by deterioration of health.

[00:03:37] Speaker 04:
So do you not think that for a table case that there has to be an acute encephalopathy proven within the first 72 hours after the vaccine?

[00:03:47] Speaker 01:
Please ask that again.

[00:03:48] Speaker 04:
Is it your view that there does not have to be for a table case

[00:03:55] Speaker 04:
Evidence of an acute encephalopathy within 72 hours of the vaccine.

[00:03:59] Speaker 01:
That is absolutely my argument.

[00:04:01] Speaker 04:
Your argument is there doesn't have to be one at all.

[00:04:03] Speaker 01:
There doesn't need to be an acute encephalopathy at all.

[00:04:07] Speaker 01:
Because what the table requires, if you look at the vaccine in the table either in the statute or in the regulation,

[00:04:26] Speaker 01:
is that you have 14.

[00:04:27] Speaker 01:
It's 42, 300, AA, 14.

[00:04:37] Speaker 01:
And this is BA.

[00:04:41] Speaker 04:
I guess I don't know what you're going to read from.

[00:04:44] Speaker 04:
I'm looking at the vaccine.

[00:04:47] Speaker 04:
Part 100, vaccine injury compensation, 100.3 vaccine injury.

[00:04:52] Speaker 01:
That's fine too.

[00:04:53] Speaker 01:
Both the table and the regulation use the same structure.

[00:04:57] Speaker 04:
So if you look at the... The table says for a DTaP vaccination, you have to prove encephalopathy within 72 hours.

[00:05:06] Speaker 01:
What it says is that the time period for first symptom or manifestation of onset or of significant aggravation

[00:05:15] Speaker 01:
after a vaccine administration.

[00:05:18] Speaker 02:
You're reading there from the statute, 300 AA-14 subsection A. Did you say that again?

[00:05:25] Speaker 02:
You're reading from the statute there.

[00:05:29] Speaker 02:
I think you are from... Both the statute and the regulation.

[00:05:34] Speaker 02:
If you look at the table itself... Right, and the regulation 100.3A uses the same language.

[00:05:42] Speaker 01:
Yeah.

[00:05:42] Speaker 01:
On the right side of the table,

[00:05:45] Speaker 01:
So on the left side is the vaccine.

[00:05:49] Speaker 01:
In the middle is the condition that qualifies for a vaccine injury table case.

[00:06:00] Speaker 01:
And on the right side is what must be proven to occur within the time frame specified by the table.

[00:06:13] Speaker 01:
And that column on the right side of the table says that the petitioner must provide the onset of the vaccine injury table condition or the significant aggravation of a vaccine injury table condition.

[00:06:39] Speaker 04:
Yes, but you have to first have had the vaccine injury table

[00:06:45] Speaker 04:
complication in order to have a significant aggravation of it, right?

[00:06:49] Speaker 04:
How can you have significant aggravation of an encephalopathy if you don't have an encephalopathy?

[00:06:55] Speaker 01:
It has to be an encephalopathy, but not an encephalopathy as defined by the qualification.

[00:07:00] Speaker 04:
You know what?

[00:07:00] Speaker 04:
You have such a limited amount of time today.

[00:07:02] Speaker 04:
Could I get you to move to your off-table claim, please?

[00:07:10] Speaker ?:
Sure.

[00:07:34] Speaker 01:
Now, on the off-table case, the question is whether the special master's analysis of the off-table case is consistent with the standards for the analytical framework set out in Loving v. Secretary of Health and Human Services, which is a six-step standard, which requires what the petitioner must prove

[00:07:59] Speaker 01:
in order to prove a off-table significant aggravation case.

[00:08:05] Speaker 01:
And it's set out by Loving v. Secretary of Health and Human Services.

[00:08:09] Speaker 01:
It is our contention that the special master got the third step of the Loving analytical framework wrong.

[00:08:18] Speaker 01:
He required, we believe,

[00:08:21] Speaker 01:
that the third step of the analytical framework requires the decision to show that there was a change for the worse in the injured person's condition after vaccination.

[00:08:38] Speaker 01:
And that the third step of loving does not include any consideration of what the natural course of the pre-existing condition would have been.

[00:08:51] Speaker 01:
that that is a part of the fact-run related defense.

[00:08:56] Speaker 01:
If the petitioner is able to prove a prima facie case, the secretary can prove that the pre-existing condition, in fact, caused the change for the worse

[00:09:10] Speaker 01:
and was the sole substantial factor in the cause of the change for the worse.

[00:09:15] Speaker 00:
The loving step three.

[00:09:17] Speaker 00:
You hear when you're talking about the pre-existing condition, you're talking about the mutated gene?

[00:09:24] Speaker 01:
Yeah, we're talking about the...

[00:09:27] Speaker 01:
Whether you call it, in the table case, it's critical.

[00:09:30] Speaker 01:
We call that an encephalopathy.

[00:09:32] Speaker 01:
But in the off-table cases, we know it was a pre-existing condition.

[00:09:37] Speaker 01:
Everyone believes, everyone can see that there was a pre-existing condition here.

[00:09:41] Speaker 02:
And as I understood Jodrina's question, is that pre-existing condition the genetic mutation?

[00:09:49] Speaker 01:
Yes.

[00:09:50] Speaker 01:
Absolutely.

[00:09:52] Speaker 01:
That's the short answer.

[00:09:53] Speaker 01:
The long answer might be both the genetic condition and the manifestations of that genetic condition.

[00:10:00] Speaker 00:
So you're saying that for step one of prong three, the special master should have looked at the condition of LH before having received the vaccine and then after the vaccine in order to detect that there was an aggravation.

[00:10:17] Speaker 00:
Please ask that again.

[00:10:18] Speaker 01:
I'm sorry.

[00:10:19] Speaker 00:
Does that answer your question?

[00:10:22] Speaker 00:
Yes.

[00:10:23] Speaker 00:
Was a special master supposed to have looked back to the condition of the child before receiving the vaccine and then looking at the condition of the child after they received the vaccine at the beginning, let's say, with the first onset?

[00:10:40] Speaker 01:
I understand the question, but the child's pre-vaccine condition is the child's

[00:10:49] Speaker 01:
clinical manifestations before vaccination.

[00:10:54] Speaker 01:
In the White Cotton case, it was a table case.

[00:10:57] Speaker 01:
But in the White Cotton case, the court's explicit holding was that you don't consider the projected outcome of a pre-existing condition

[00:11:17] Speaker 01:
when you're determining whether the child suffered a significant aggravation.

[00:11:24] Speaker 01:
That was the critical holding in the white cotton cast.

[00:11:29] Speaker 01:
And the reason, and they went on to say, that that issue in a people case can be

[00:11:39] Speaker 01:
The expected outcome of the pre-existing condition can be the source of a defense for the Secretary of Health and Human Services if the Secretary is able to demonstrate that the

[00:11:56] Speaker 01:
pre-existing condition would have caused the significant aggravation.

[00:12:00] Speaker 04:
Do I understand?

[00:12:01] Speaker 04:
I'm familiar with white cotton and I'm very familiar with the loving factors.

[00:12:06] Speaker 04:
I think that if I understand it right, one of your arguments is that the special master's fact findings across the board were erroneous in part because they were pervaded by this view that somehow you had to disprove that the mutation is why she is the way she is today.

[00:12:26] Speaker 04:
It's almost like he didn't sort of look right before the vaccine and right after and say, what's going on?

[00:12:31] Speaker 04:
He's looking at how she is today and saying, well, the evidence of record shows it's possible with someone for this mutation to end up as bad as she is.

[00:12:39] Speaker 04:
Therefore, you haven't met your burden of proving significant aggravation.

[00:12:43] Speaker 04:
And that seems to me to possibly be an error of law that pervades his fact findings because he's putting the burden on you to disprove the mutation as opposed to looking at whether you've established

[00:12:55] Speaker 04:
causation.

[00:12:57] Speaker 01:
That is exactly my argument.

[00:12:59] Speaker 01:
And across the board, the way you said it is perfectly right.

[00:13:02] Speaker 01:
Across the board, the special master assumed that the presence of a genetic mutation that could have cost LM's current condition

[00:13:19] Speaker 01:
that the presence, the mere presence of a genetic mutation capable of causing a bad outcome was sufficient evidence to prove that there was a bad outcome and to preclude us from proving our case.

[00:13:34] Speaker 01:
And that was a fundamental legal error because it was inconsistent with the Knudsen case, which, once again, that was the finding of the Knudsen case, that the presence of an alternate factor of a potential alternate cause alone

[00:13:49] Speaker 01:
Is it enough?

[00:13:50] Speaker 04:
You're into your rebuttal time.

[00:13:51] Speaker 04:
Do you want to save the remainder?

[00:13:53] Speaker 01:
I'm sorry?

[00:13:53] Speaker 04:
You're in your rebuttal time now.

[00:13:54] Speaker 04:
Would you like to save the rest?

[00:13:56] Speaker 01:
I will come back.

[00:13:58] Speaker 04:
Very good.

[00:13:58] Speaker 04:
Let's hear from the government.

[00:14:07] Speaker 03:
Good morning, Your Honors.

[00:14:08] Speaker 03:
May it please the court

[00:14:10] Speaker 03:
It's not necessary for the court to reach the question of what legal standards should apply in on-table significant aggravation cases.

[00:14:17] Speaker 03:
Because the court can resolve this appeal on a single narrow factual issue, and that is that the special master found that Ellen's vaccines did not significantly aggravate her pre-existing condition because her genetic mutation by itself explains her outcome.

[00:14:31] Speaker 04:
Are you framing that as the rebuttal that the government gets to undertake, a la if she establishes causation, if she meets her burden, then the burden flips to the government to disprove causation?

[00:14:45] Speaker 04:
So you're kind of hinging on footnote 47 where he says, oh yeah, and even if the government met this alternative burden of theirs, is that where you're starting right now?

[00:14:54] Speaker 03:
I think that gets into whether we're talking about an on-table case or an off-table case.

[00:14:57] Speaker 04:
I said I want you to focus only on off-table.

[00:14:59] Speaker 03:
Right.

[00:14:59] Speaker 03:
And so because we are focusing on the off-table case that the petitioner is making, the petitioner is the burdened party.

[00:15:06] Speaker 03:
And so it is their burden of persuasion.

[00:15:08] Speaker 04:
And this court is held in cases like WC and also- Yes, but if they've established causation, you then have to come back and prove that, no, it was something else.

[00:15:19] Speaker 03:
But this court has held that the special masters are permitted to consider the government's evidence in determining whether the petitioner has made a prima facie case in an off-table claim.

[00:15:30] Speaker 03:
And that is what the special master did here.

[00:15:32] Speaker 03:
He acknowledged that the petitioner provided

[00:15:35] Speaker 00:
some evidence to support their claim that the... Our law does not support the proposition that any time there's an alternative causation, that that's going to dictate the outcome.

[00:15:48] Speaker 00:
And then it's the burden on the petition to prove otherwise.

[00:15:52] Speaker 03:
No, the burden is on the Special Master to weigh the evidence and look at all of the evidence that's submitted.

[00:15:57] Speaker 00:
But it seems to me that your argument is that once there's an alternative, in this case the mutated gene, then that's it.

[00:16:04] Speaker 00:
That dictates the outcome from the Special Master's point of view.

[00:16:07] Speaker 03:
Respectfully, Your Honor, I don't think that's what the Special Master did and that's not what we were arguing.

[00:16:11] Speaker 03:
The petitioner's experts in this case relied primarily on the location of the mutation on the gene.

[00:16:19] Speaker 03:
This is primarily from their geneticist, Dr. Bowles, who argued that because the mutation was in the stem domain of the gene, that mutations in that part of the gene are generally associated with a milder outcome.

[00:16:32] Speaker 04:
Well, Dr. Descartes, the government's expert, agreed with that, but then said, in her words, there are exceptions to that rule.

[00:16:39] Speaker 04:
So if there's a bell curve, there's no doubt that LM is among the worst impacted in terms of her cognitive disability and her gross motor skill disability based on all the studies that were presented to us in the appendix.

[00:16:55] Speaker 04:
And so what Dr. Discard has testified to is just because this is located in the tail

[00:17:01] Speaker 04:
or stem doesn't mean it couldn't happen.

[00:17:05] Speaker 04:
It is just that if it's located in the motor portion of the gene, it's much more likely to cause a severe impact in the expression of the protein and then the impact on cognitive and

[00:17:17] Speaker 04:
Am I saying this all right?

[00:17:18] Speaker 03:
Yes.

[00:17:18] Speaker 03:
Yes.

[00:17:18] Speaker 03:
According to Dr. Descartes and the medical literature that she relied on, there are exceptions.

[00:17:24] Speaker 03:
There are instances where mutations that are in the stem domain are associated with more severe outcomes.

[00:17:30] Speaker 04:
So here's my problem.

[00:17:31] Speaker 04:
My problem for that is she referred to that as the exception.

[00:17:35] Speaker 04:
And my problem is it depends

[00:17:36] Speaker 04:
on whose burden it is, right?

[00:17:39] Speaker 04:
If it's their burden to prove that it couldn't have been the gene that caused it, then her testimony might be enough.

[00:17:46] Speaker 04:
Well, it's normally not the case that somebody with the mutation in the location she has it is this severe, but it does in an exceptional case happen.

[00:17:56] Speaker 04:
But if it's your burden to have to establish that this was more likely the cause than the vaccine,

[00:18:04] Speaker 04:
that I'm not sure her testimony that in an exceptional case somebody with it at this location could be this bad could ever satisfy your burden.

[00:18:13] Speaker 04:
Do you understand?

[00:18:14] Speaker 03:
I do, Your Honor, but she had the added evidence of an individual with the exact same mutation that LM has.

[00:18:20] Speaker 04:
I'm so glad you brought that up because here's some clear errors of law in the special master's conclusions.

[00:18:25] Speaker 04:
Do you know that he found that LM's mutation was de novo?

[00:18:29] Speaker 04:
Do you know what that means?

[00:18:31] Speaker 03:
Yes, she did not inherit it from either of her parents.

[00:18:34] Speaker 04:
Except were both of her parents tested?

[00:18:36] Speaker 03:
There is a question about it.

[00:18:38] Speaker 03:
It appears that her father was not tested.

[00:18:39] Speaker 04:
The father was not tested.

[00:18:41] Speaker 04:
So does that mean we know for sure it's de novo?

[00:18:45] Speaker 03:
We do not in terms of the... So we don't.

[00:18:49] Speaker 04:
We don't know if it's de novo, but yet the special master found it was de novo, and Dr. Descartes at page A388 used that, the conclusion that LM's own presentation was de novo, as further evidence supporting the idea that people with de novo expressions of this mutation are more likely at the severe end of the disability chain.

[00:19:13] Speaker 04:
So isn't that a real problem?

[00:19:15] Speaker 04:
Your expert relied on a fact that she understood to be true about LM that's not actually true or proven in this case.

[00:19:23] Speaker 03:
First of all, I'm not sure that that finding has been challenged on appeal.

[00:19:27] Speaker 03:
But second of all, that was not the only piece of information that the expert relied on.

[00:19:31] Speaker 03:
She relied on the fact that there is an exact person with this exact mutation.

[00:19:36] Speaker 04:
And that person, guess what?

[00:19:37] Speaker 04:
Was de novo.

[00:19:38] Speaker 04:
The study makes it clear.

[00:19:39] Speaker 04:
And she actually says it expressly.

[00:19:41] Speaker 04:
That person had a de novo expression.

[00:19:43] Speaker 04:
And she does say at 388 that familial expressions are usually far less severe.

[00:19:50] Speaker 04:
So we don't know whether LM's expression was de novo, but this special master treated it as though it was, and your expert did as well.

[00:19:58] Speaker 04:
And that was part of what she wrapped into her conclusion in his fact finding, him being the special master, her being the expert.

[00:20:06] Speaker 04:
So I don't know what to do with that.

[00:20:09] Speaker 03:
All I can tell you, Your Honor, is that that's not the sole piece of information that was relied upon.

[00:20:14] Speaker 03:
There was also the testimony of our pediatric neurologist who testified about infantile spasms and testified that the course of LM, the clinical course,

[00:20:25] Speaker 03:
was consistent with what he sees with all of his patients with infantile spasms.

[00:20:30] Speaker 03:
There also is just no evidence that links vaccines with causing or significantly aggravating infantile spasms.

[00:20:38] Speaker 04:
Stop for a second.

[00:20:39] Speaker 04:
Descartes testified, and this is again your expert, that her spike in fever could have caused the seizure that she then experienced, right?

[00:20:49] Speaker 04:
The spike in fever, which is the result of the vaccine, could have caused the seizure.

[00:20:53] Speaker 03:
She testified that was possible.

[00:20:55] Speaker 04:
And then she also testified that once you have seizures, you're more prone to having more seizures.

[00:21:01] Speaker 03:
I don't recall that being her testimony.

[00:21:03] Speaker 03:
I believe that was the testimony of the petitioner's expert.

[00:21:06] Speaker 04:
OK.

[00:21:06] Speaker 04:
Well, in any event, either way, if the vaccine caused a fever which caused the seizure, and then if the record only has evidence that suggests that seizures, sort of each new seizure causes an increase,

[00:21:22] Speaker 04:
in damage and therefore makes you more susceptible to more seizures.

[00:21:26] Speaker 04:
I guess I'm really struggling with the factual presentation of this case.

[00:21:35] Speaker 03:
Well, then let's move away from the prong three and talk about the other prongs of often because the other issue with petitioners off-table case

[00:21:43] Speaker 03:
is the special master correctly found that they did not offer a medical theory explaining how vaccines actually could significantly aggravate interact with this genetic mutation to aggravate her underlying disorder.

[00:21:55] Speaker 04:
Well, if they did establish and your expert did that the vaccine caused the fever, the fever caused the seizure.

[00:22:01] Speaker 04:
And then if their experts say, and once you start having seizures,

[00:22:05] Speaker 04:
It's going to escalate the seizure disorder.

[00:22:09] Speaker 04:
Why isn't that enough?

[00:22:10] Speaker 03:
That wasn't their theory, though.

[00:22:11] Speaker 04:
But it was one of the things their expert expressly said.

[00:22:14] Speaker 03:
Not in terms of by preponderance of the evidence or more likely than not, this is what happened.

[00:22:21] Speaker 03:
The special master examined all of their evidence.

[00:22:24] Speaker 03:
Dr. Bowles, their geneticist, said he had no idea which vaccine even was the causal vaccine.

[00:22:30] Speaker 03:
But he wasn't really focusing on that.

[00:22:31] Speaker 03:
He was more focused on the temporal connection between the vaccines and her seizures that did not actually occur within the table time frame.

[00:22:42] Speaker 03:
Dr. Schuman focused on supposed MRI abnormalities that the treating physicians who read the MRIs did not even identify.

[00:22:52] Speaker 03:
And he was trying to somehow link the MRI abnormalities to interacting with vaccines.

[00:22:57] Speaker 03:
But he never really explained the theory either.

[00:22:59] Speaker 03:
So setting aside whether the vaccine caused the initial seizure and that somehow changed the course, petitioners not offered a theory to explain how that happens, which is part of their burden.

[00:23:12] Speaker 04:
I guess I'm confused because part of what's bothering me about this case is you have a little girl who, at a wellness visit, was lifting up her head, was babbling, was reaching for things, was making great eye contact.

[00:23:28] Speaker 04:
Then she's administered a vaccine.

[00:23:30] Speaker 04:
She spikes an immediate fever.

[00:23:31] Speaker 04:
There are frantic phone calls from her mother to the doctor, phone calls to the ER, takes the girl to the ER after she has what is a full-blown, undoubtedly described seizure.

[00:23:40] Speaker 04:
And she proceeds in the hospital to have a bunch more seizures while she's in the hospital.

[00:23:47] Speaker 04:
It's hard for me to imagine a circumstance, and she has never returned, by the way, to the child that she was before the vaccination.

[00:23:56] Speaker 04:
So it's hard for me to imagine how we wouldn't say there's proven aggravation here.

[00:24:02] Speaker 04:
That's where I'm struggling.

[00:24:03] Speaker 03:
Well, because this court's holdings say that in determining whether there is a significant aggravation, a significant change for the worse, you look at what the known natural course of the disease is.

[00:24:16] Speaker 03:
And as Dr. Zempel, our pediatric neurologist, testified, infantile spasms, they arise between 6 and 12 months of age, which is the age at which children are receiving vaccines on almost a monthly basis.

[00:24:32] Speaker 03:
just by chance alone that this is going to arise in temporal proximity to vaccination is a given.

[00:24:40] Speaker 03:
And as Dr. Semple also testified and the special master found, Ellen was likely experiencing mild seizures before her vaccinations.

[00:24:48] Speaker 03:
They were just unrecognized by her parents, but the medical records

[00:24:51] Speaker 03:
post-vaccination include reports from the parents saying, oh, now looking back, we noticed that there were these times when she would space out.

[00:24:59] Speaker 03:
And the special master found, based on Dr. Zempel's testimony, that those very likely could have been seizures that were occurring before vaccination.

[00:25:09] Speaker 02:
That's just the natural course of an infantile spasm.

[00:25:11] Speaker 02:
Why was the vaccine an aggravation?

[00:25:13] Speaker 02:
From mild to severe seizures.

[00:25:16] Speaker 03:
Because part of proving that it's an aggravation is proving that the vaccines somehow changed the course of this condition.

[00:25:24] Speaker 03:
And this is exactly the same analysis that this court has encountered before in the SCN1A genetic mutations.

[00:25:30] Speaker 00:
In which case?

[00:25:31] Speaker 03:
These are the Stone and Hammett, the Harrison-Sider cases.

[00:25:34] Speaker 03:
These are the string of the Gervais syndrome cases, a number of which have come up to this court, all of which have been affirmed.

[00:25:40] Speaker 03:
They all involve gene mutations.

[00:25:43] Speaker 03:
You don't mention White Cotton.

[00:25:45] Speaker 04:
Which preceded those cases?

[00:25:48] Speaker 03:
Well, White Cotton was a table case, and I can address the table claim if you'd like, but there is no evidence in this case that would support that LM suffered a table encephalopathy either before or after her vaccinations.

[00:26:03] Speaker 04:
Didn't Loving expressly say it was adopting the White Cotton factors?

[00:26:08] Speaker 03:
Well, yes.

[00:26:11] Speaker 04:
And that's three through five.

[00:26:13] Speaker 04:
It expressly said, we're adopting the white cotton factors, but we should somehow read in an exclusion to white cotton's view of what you consider and don't consider as part of those factors.

[00:26:23] Speaker 03:
Well, I'm not sure what you're referring to in white cotton at this point.

[00:26:27] Speaker 03:
My reading of white cotton is that that was a case involving a child who the special master had found had a preexisting

[00:26:35] Speaker 03:
encephalopathy based on the fact that she had microcephaly.

[00:26:38] Speaker 03:
And so the question there was then when she got vaccinated and a few days later experienced seizures, whether that constituted a significant aggravation of her previous encephalopathy.

[00:26:50] Speaker 04:
Can you turn to page 309 of the appendix with me, page 309?

[00:26:54] Speaker 04:
And I only want you to do this because you suggested to me that you didn't believe Dr. Descartes testified as I was suggesting about

[00:27:05] Speaker 04:
seizures causing more seizures and being the causation.

[00:27:08] Speaker 04:
So page 309, I understand this to be her expert report.

[00:27:12] Speaker 04:
Am I mistaken about what this document is?

[00:27:16] Speaker 03:
If you could direct me to where on the page you're looking.

[00:27:20] Speaker 04:
I am currently looking at neuroinflammation.

[00:27:24] Speaker 04:
Do you see where she says that?

[00:27:27] Speaker 04:
Neuroinflammation is the start of a paragraph about halfway in the middle of the page.

[00:27:33] Speaker 04:
Do you see that or not?

[00:27:35] Speaker 03:
I see her stating that in a general sense.

[00:27:37] Speaker 04:
Wait.

[00:27:38] Speaker 04:
You see where she says neuroinflammation is a putative common mechanism in different forms of EE.

[00:27:43] Speaker 04:
Wait.

[00:27:44] Speaker 04:
Here's the important part.

[00:27:45] Speaker 04:
Seizures induce neuroinflammation, which in turn fosters further seizures.

[00:27:53] Speaker 04:
Do you see that to be the government's expert's opinion?

[00:27:56] Speaker 03:
Again, Your Honor, I see her stating that in a general sense.

[00:27:59] Speaker 03:
I do not see her stating that that is actually what happened in this case.

[00:28:05] Speaker 03:
I mean, her exact opinion was that the vaccines did not alter her outcome.

[00:28:12] Speaker 03:
So I find it hard to see how her making that statement.

[00:28:16] Speaker 03:
I know.

[00:28:16] Speaker 04:
I also found it hard to see how she got to that conclusion.

[00:28:25] Speaker 03:
Your Honor, I see that my time is running short.

[00:28:27] Speaker 03:
I will just wrap up by saying that the evidence in these cases

[00:28:32] Speaker 03:
Similar in nature to that that was presented in the SCN1-A Gervais syndrome cases, which this court affirmed the special master's finding in those cases that the genetic mutation alone explained the outcome and the vaccines did not alter the clinical course.

[00:28:47] Speaker 04:
Is this the Dravet syndrome cases?

[00:28:48] Speaker 03:
Yes, Your Honor.

[00:28:49] Speaker 04:
I see the parallels between them.

[00:28:51] Speaker 04:
But it was another thing that bothered me about the special master's decision was he expressly said he was relying on them in his assessment.

[00:28:58] Speaker 04:
And I thought,

[00:28:59] Speaker 04:
It seems wrong for him to rely on cases involving an entirely different genetic mutation as part of his analysis of concluding whether she established causation in this one.

[00:29:12] Speaker 04:
I mean, do you think it's proper to do that?

[00:29:14] Speaker 03:
I think the fact that this court has affirmed on numerous occasions Special Master's analyses in those cases, it was appropriate for the Special Master to employ a similar analysis based on similar evidence in this case.

[00:29:25] Speaker 03:
And for that reason, we think it should be affirmed.

[00:29:33] Speaker 04:
Mr. Webb, do you have some rebuttal time?

[00:29:41] Speaker 01:
Real briefly, first on our table case, I wanted to point out that in White Cotton, the Court of Appeals focused on whether they had going to change, that is, a significant aggravation

[00:30:02] Speaker 01:
in Maggie White Cotton's condition, not on whether that condition satisfied the definition of encephalopathy.

[00:30:11] Speaker 01:
There's no discussion of whether the post-vaccine condition of that child matched the definition of encephalopathy.

[00:30:22] Speaker 01:
The whole question is whether a condition is hidden.

[00:30:26] Speaker 01:
And then I want to focus real quickly on

[00:30:29] Speaker 01:
The question about the SCN1A cases, the SCN1A cases show what the secretary did not prove in this case and did prove in the SCN1A cases.

[00:30:45] Speaker 01:
In the SCN1A cases, most children that had an SCN1A gene mutation had a severe outcome, overwhelming majority, 70%, 80% at least.

[00:30:57] Speaker 01:
of the children with that gene mutation had a bad outcome.

[00:31:01] Speaker 01:
Moreover, the vast majority of the kids with SCN1A gene mutations suffered the onset of seizures at four, six, eight months of age.

[00:31:14] Speaker 01:
In other words, the change

[00:31:17] Speaker 01:
The change, they showed that the timing of the change for the worse was consistent with the gene mutation causing the problem.

[00:31:28] Speaker 01:
And they also showed in laboratory animals there was a shift from the

[00:31:35] Speaker 01:
from using the SCN1B ion channel to the SCN1A ion channel at about the equivalent of a four, six month age.

[00:31:48] Speaker 01:
These were mice and rats.

[00:31:51] Speaker 01:
But basically they showed...

[00:31:56] Speaker 01:
The Alton test that is required of petitioners requires a medical theory.

[00:32:01] Speaker 01:
It requires a proof of logical sequence of cause and effect.

[00:32:05] Speaker 01:
And it requires an appropriate temporal relationship between the vaccination and the child's injury.

[00:32:17] Speaker 01:
The respondent, the secretary, should be required to make the same kind of showing.

[00:32:22] Speaker 02:
Can I just ask as a factual matter on that medical theory of causation?

[00:32:29] Speaker 02:
So this would be what?

[00:32:30] Speaker 02:
Loving factor four, and I forget what factor, and often one of them.

[00:32:36] Speaker 02:
The special minister, after discussing

[00:32:41] Speaker 02:
the material focused on the genetic mutation and where on this very large molecule this one occurred.

[00:32:50] Speaker 02:
Then said separately, the second deficiency of Petitioner's theory is more fatal to the claim.

[00:32:56] Speaker 02:
This is the paragraph at, I guess, appendix page 55.

[00:33:02] Speaker 02:
and says, Dr. Bowles did not persuasively explain how the vaccines interacted with the mutation to worsen the anticipated phenotype, or even how they could do so.

[00:33:19] Speaker 02:
On what basis would we find that finding lacking in substantial evidence?

[00:33:29] Speaker 01:
Well, Dr. Truman testified

[00:33:32] Speaker 01:
that the genetic mutation and the brain abnormalities associated with it made a child more susceptible to developing seizures.

[00:33:45] Speaker 01:
But the fever associated with the vaccine, everyone agrees that occurred, that caused a seizure.

[00:33:55] Speaker 01:
In his opinion, it was the first seizure.

[00:33:58] Speaker 01:
if you accept the special master's finding that there were at least one prior seizure, it changed the seizure disorder from maybe one or a few seizures to constant seizures.

[00:34:10] Speaker 01:
So there was a change in the seizure pattern, too.

[00:34:12] Speaker 01:
But that vaccine-related seizure was the first seizure documented in the medical records.

[00:34:18] Speaker 01:
And from that point on, she had a catastrophic

[00:34:22] Speaker 01:
and many other changes as well, cephalopathic changes.

[00:34:26] Speaker 02:
So I think Judge Moore read a portion of Dr. Descartes's

[00:34:31] Speaker 02:
expert report seeming to recognize that the fevers cause seizures and once you have seizures, it causes lingering effects on the brain that could cause more.

[00:34:47] Speaker 02:
Are you saying that Dr. Bowles also testified to the vaccine fever seizure connection?

[00:34:56] Speaker 01:
I have to say, honestly, I don't know whether he testified to that connection.

[00:35:01] Speaker 04:
That concludes our arguments for today.