[00:00:00] Speaker 03:
The final case for argument this morning is 24-1787 Bonsall versus HHS.

[00:00:08] Speaker 03:
Mr. McHugh, whenever you're ready.

[00:00:09] Speaker 01:
Good morning, Your Honor.

[00:00:11] Speaker 01:
This is a case of a seven-month-old baby, young lady, who had her four-month vaccinations in the morning.

[00:00:23] Speaker 01:
And 13 hours later, she had a seizure which was deemed

[00:00:28] Speaker 01:
Partially, it was fibril.

[00:00:30] Speaker 01:
It was not very big fibril, but it was fibril.

[00:00:33] Speaker 01:
And then this seizure lasted 20 minutes.

[00:00:38] Speaker 01:
It started when she was in the living room with her father.

[00:00:40] Speaker 01:
It was a colonic seizure, which means it's the ones where they stiffen and bend sort of backwards.

[00:00:49] Speaker 01:
EMS was called.

[00:00:51] Speaker 01:
They were there quickly.

[00:00:53] Speaker 01:
And they gave her a drug that knocked it down.

[00:00:58] Speaker 01:
By the time they got to the hospital and get into the emergency room, it continued.

[00:01:03] Speaker 01:
So it went for 20 minutes.

[00:01:05] Speaker 03:
Can I?

[00:01:05] Speaker 03:
I mean, we're familiar with the history, and we've read the briefs.

[00:01:08] Speaker 03:
We're familiar with the history of this case.

[00:01:10] Speaker 03:
OK, that would be fine.

[00:01:10] Speaker 03:
I just, as a threshold matter, are you pursuing the aggravation theory here, or is your theory limited to causation?

[00:01:20] Speaker 01:
Well, it is causation, but it's also aggravation, because the problem we have here is

[00:01:28] Speaker 01:
This fibril seizure occurred.

[00:01:31] Speaker 01:
And then there was a three-month gap.

[00:01:32] Speaker 01:
And then the seizure, but it's typical of this disease that there's a first seizure, and it leaves no fingerprints.

[00:01:43] Speaker 01:
And then sometimes a second or third, also no fingerprints.

[00:01:47] Speaker 01:
But the seizures continue and continue, and they get more severe as we go along.

[00:01:51] Speaker 01:
And so we started out with causation because, of course, the problem we had was

[00:01:58] Speaker 01:
And at the time this was filed, an SC1A procedure was deemed to be causal.

[00:02:05] Speaker 01:
There is actually no evidence that it is.

[00:02:08] Speaker 01:
All we have is evidence that in most of these cases, they find it.

[00:02:13] Speaker 01:
But they don't know how that translated into causing it, because there are cases that it doesn't.

[00:02:18] Speaker 01:
They don't find it.

[00:02:20] Speaker 01:
In this particular case, we have the special master, who is the one who came up with the idea that this was SC1A.

[00:02:29] Speaker 01:
had cases, he basically decided our experts were not credible.

[00:02:37] Speaker 01:
And the government's expert was.

[00:02:39] Speaker 01:
I know, but just going back to what theory you're pursuing here.

[00:02:42] Speaker 01:
Well, the theory is the SC1A was there.

[00:02:47] Speaker 01:
It is a susceptibility.

[00:02:50] Speaker 01:
It is not cause.

[00:02:51] Speaker 01:
The cause was the DP18 vaccination she got.

[00:02:57] Speaker 01:
And that was pretty much conceded because the government had asked them.

[00:03:01] Speaker 03:
So that caused her to have the seizure and also the development of the seizure disorder?

[00:03:06] Speaker 03:
Well, that's where the fight is.

[00:03:09] Speaker 01:
The special master conceded it probably caused the seizure.

[00:03:13] Speaker 01:
But then he said, but after the seizure, she was fine.

[00:03:17] Speaker 01:
She had to hand it.

[00:03:18] Speaker 01:
The tests were done, and she was absolutely normal, which is true in almost every case of rabbit syndrome.

[00:03:24] Speaker 01:
They always test normal after the seizure.

[00:03:27] Speaker 03:
Yeah, but notwithstanding that finding by the special master, is it your position that the vaccine triggered the development of the seizure disorder?

[00:03:38] Speaker 01:
Absolutely.

[00:03:39] Speaker 01:
Absolutely.

[00:03:41] Speaker 01:
And the special master, we think it's basically a case of abusive discretionary to some extent, but the special master,

[00:03:48] Speaker 05:
Our experts rely... Just to be clear, so there's a causation of the disorder.

[00:03:55] Speaker 05:
You just said you're making that claim.

[00:04:00] Speaker 05:
Are you also making a claim that the disorder is worse than it otherwise would have been, namely an aggravation claim, because of the initial seizure having been caused by the vaccine?

[00:04:16] Speaker 05:
Yes.

[00:04:17] Speaker 01:
We go to, both our experts cited to Tata et al, which is a study where they tried to replicate this disease.

[00:04:27] Speaker 01:
They had mice that had knock in the mutation that would cause the seizure.

[00:04:36] Speaker 01:
They then heeded those mice until they seized, which is what happens with kids with fevers.

[00:04:42] Speaker 01:
And then they left them for two months.

[00:04:45] Speaker 01:
And then they,

[00:04:47] Speaker 01:
They developed seizures using other methods.

[00:04:49] Speaker 01:
And they found that the mice who had been subjected to it.

[00:04:54] Speaker 04:
By following the argument you're about to make, it seems like it's evidence that could have been accredited by the special master.

[00:05:00] Speaker 04:
And maybe you could have prevailed.

[00:05:03] Speaker 04:
But how does that help us?

[00:05:04] Speaker 04:
We have to decide that there was not sufficient evidence for the way that the special master went.

[00:05:11] Speaker 01:
That's the case.

[00:05:12] Speaker 01:
He essentially, it's very interesting, he actually read the doctor report.

[00:05:17] Speaker 01:
And he analyzed it correctly, that basically what the Dutton Report said was that where kids or mice had had a terrible seizure in a very young age, when they had seizures later on, those seizures were much worse than the seizures in mice who seized without having had a terrible seizure before.

[00:05:41] Speaker 01:
So that is the entire case.

[00:05:43] Speaker 01:
He analyzed it properly and ignored it.

[00:05:46] Speaker 01:
And he said there was no evidence that connected the fibril seizure to the assortment.

[00:05:52] Speaker 01:
And that was complete abuse of discretion.

[00:05:54] Speaker 01:
He read the reports and didn't comment on it.

[00:05:59] Speaker 01:
The only comment was from their expert, who said that the young lady did not get heated.

[00:06:06] Speaker 01:
She was not heated.

[00:06:09] Speaker 01:
That is what a fibril seizure is.

[00:06:11] Speaker 01:
It is a fever.

[00:06:12] Speaker 01:
That is the heat.

[00:06:14] Speaker 01:
And the replication was,

[00:06:15] Speaker 01:
When a kid had a mouse had a fipple seizure and then had a seizure later on, those seizures were much more severe.

[00:06:23] Speaker 01:
So our argument is her terrible situation right now, where she's having seizures all the time, is directly related to that seizure.

[00:06:32] Speaker 01:
And that seizure was caused by the fever which was caused by the vaccination the morning before.

[00:06:40] Speaker 01:
So that's the thrust of our case.

[00:06:42] Speaker 01:
Now, the other thing I found.

[00:06:45] Speaker 01:
indicating some problem with a special measure, was he took the idea that the first seizure didn't leave any fingerprints as a sign that didn't leave anything, that had nothing to do with anything.

[00:06:56] Speaker 01:
And that is basically all literature involving this particular seizure disorder shows that every one of them starts with a seizure, a fibril seizure that does nothing, and then another one that does nothing.

[00:07:10] Speaker 01:
So even though medicine cannot see what the damage is done,

[00:07:13] Speaker 01:
The damage is there, and the only reason you know it's there is because basically all hell breaks loose later on.

[00:07:19] Speaker 01:
So we think that the special master abused discretion in ignoring the Dutton Report and holding that there was no evidence that the fibril seizure caused the long term.

[00:07:38] Speaker 03:
So why don't we hear from the government, and we will safely remain to your time for rebuttal if you need it.

[00:07:43] Speaker 03:
Thank you.

[00:07:46] Speaker 00:
Good morning and may please the court.

[00:08:02] Speaker 00:
As Mr. McHugh notes, this case concerns a child with a genetic seizure disorder called Dravet syndrome, which clinically manifests around six months of age, coinciding with proceed of standard childhood vaccines.

[00:08:16] Speaker 00:
More than a dozen Gervais cases have been adjudicated in the vaccine court in as many years, including the Außenbach case rolled on by this court just seven weeks ago.

[00:08:25] Speaker 00:
And as this court recently noted in Außenbach at three, in vaccine cases, special master's fact findings are reviewed under the arbitrary and capricious standard, and reversible error is extremely difficult to demonstrate.

[00:08:38] Speaker 00:
If the special master considered the relevant evidence of record, drew plausible inferences

[00:08:44] Speaker 00:
and articulated a rational basis for the decision.

[00:08:47] Speaker 03:
And is it your view that the evidence presented in the expert testimony and all of the other precedent that you've just referred to, those six cases, was similar or the same as presented in this case?

[00:09:00] Speaker 00:
Some of it was.

[00:09:01] Speaker 00:
But most importantly, as special masters should for all causation impact cases, Special Master Moran

[00:09:09] Speaker 00:
specifically assess the facts in this case.

[00:09:13] Speaker 00:
He looked at the articles presented in this case and analyzed them and then weighed all of the evidence and determined that the petitioners had failed to prove that AV's April 2015 vaccinations were a but poor cause of Herter Day Syndrome.

[00:09:31] Speaker 00:
Petitioners have not pointed to any material evidence overlooked by the special master.

[00:09:36] Speaker 05:
Well, we heard just a few minutes ago about, I think, an assertion of disregard of, was it Dutton?

[00:09:44] Speaker 05:
Is that the name?

[00:09:45] Speaker 05:
Did I get the name right?

[00:09:47] Speaker 05:
The Dutton report about the mice and how later seizures were worse in the subgroup that had an initial feeble

[00:09:59] Speaker 05:
seizure than in the other group.

[00:10:07] Speaker 00:
The Dutton study was submitted at the very beginning of the case and was responded to by Respondent's expert Dr. Raymond in his very first report, exhibit A at five.

[00:10:21] Speaker 00:
The court can find exhibit A in the appendix at 2496.

[00:10:27] Speaker 00:
And the special master did consider it, among other animal studies that were submitted in the case.

[00:10:34] Speaker 00:
But ultimately, the special master concluded looking at human studies, animal studies, studies specific to what we know about the SBN1A gene itself, that petitioner had not met their burden in this particular case.

[00:10:52] Speaker 04:
Where can we find the special master's discussion of that?

[00:11:30] Speaker 00:
Thank you, Mr. McHugh.

[00:11:39] Speaker 02:
I think I see it on page Appendix 56.

[00:11:43] Speaker 00:
Yes, that's what Mr. McHugh just pointed out to me.

[00:11:48] Speaker 00:
So again, it's just one of several animal studies presented in this case.

[00:11:56] Speaker 00:
Dr. Raymond critiqued this study because it was specific to guest plus, which is on the spectrum of SCN1A disorders, one of the milder disorders.

[00:12:08] Speaker 00:
It's also, so not Gervais syndrome, which is what AD was diagnosed with in this case by both of her neurologists and Dr. Raymond agreed with

[00:12:24] Speaker 00:
There are diagnoses based on the medical records and presentation in this particular case.

[00:12:29] Speaker 00:
So it's not the same level of disease that was tested.

[00:12:34] Speaker 00:
It's also an animal model.

[00:12:36] Speaker 05:
Does the point you just made about how the Dutton study did not involve Gervais syndrome, is that to be found in the special master's report?

[00:12:46] Speaker 05:
I think you referred to Dr. Raymond making that distinction.

[00:13:12] Speaker 00:
I'm not sure that he points out that distinction in this recitation.

[00:13:17] Speaker 00:
OK.

[00:13:21] Speaker 00:
But that is something that is certainly in the record, as explained by Dr. Raymond in exhibit A, and potentially in his future reports as well.

[00:13:35] Speaker 04:
Mr. McHugh also contends that the special master found that the first seizure was just a one-off.

[00:13:40] Speaker 04:
I do agree that the Special Master did that, and if so, isn't that an error?

[00:13:46] Speaker 00:
No, as explained in our brief, that term, one-off, doesn't appear anywhere in the Special Master's decision, and the Special Master did appropriately characterize the first

[00:13:59] Speaker 00:
febrile seizure in the case and acknowledged that it was a manifestation, an effect of her Gervais syndrome, but did not cause or worsen her Gervais syndrome based on the evidence as a whole.

[00:14:14] Speaker 00:
The government agrees with petitioners that the de novo SEM1A variant made her susceptible to febrile seizures around six months of age, but that's true for all children with Gervais syndrome.

[00:14:27] Speaker 00:
Because the SCN1A gene helps maintain the balance of excitation and inhibition in the brain, children with Gervais syndrome can have febrile seizures after anything that elevates their temperature, be it a vaccine, a virus, a hot bath.

[00:14:42] Speaker 00:
Eventually, as they age, they will develop seizures that don't need a high temperature to induce them.

[00:14:48] Speaker 00:
So that's also responsive to the suggestion that Mr. Ngu made that scientists don't understand

[00:14:57] Speaker 00:
The reason why a de novo mutation in the SCN1A gene would have a pathogenic effect, they do now.

[00:15:08] Speaker 00:
In the record here, we have the genetic reports, both from 2017 and from 2018.

[00:15:13] Speaker 00:
We have identification by the neurologist attributing the child's Gervais syndrome to her SCN1A gene.

[00:15:22] Speaker 00:
mutation, and we have the assessment by Dr. Raymond in the case over the PERSA 3 expert reports that explain why the particular frame shift mutation in this particular case, that's an insertion of five base pair amino acids, it results in a loss of function protein, why that would have a pathogenic effect in the child.

[00:15:54] Speaker 03:
Anything further?

[00:15:56] Speaker 00:
Unless the court has any specific questions, under the deferential standard of review in this case, the special master's decision should be affirmed.

[00:16:05] Speaker 00:
Thank you.

[00:16:05] Speaker 00:
Thank you.

[00:16:14] Speaker 01:
The difference in this case before, a lot of cases, we're dealing with experts who are theorizing that this must have happened because of that, without direct connection

[00:16:24] Speaker 01:
got any direct connection.

[00:16:27] Speaker 01:
This Dutton study is a direct connection.

[00:16:30] Speaker 01:
They were studying seizures.

[00:16:31] Speaker 01:
They weren't studying the rats.

[00:16:33] Speaker 01:
They were studying seizure disorders, period, across the board.

[00:16:36] Speaker 01:
And they heated the mice to give them the temperature that the kid would have had.

[00:16:41] Speaker 01:
And they found out that that seizure, the first cerebral seizure, also left no traces.

[00:16:48] Speaker 01:
But the seizures, they instilled later on when the kids were basing what they deemed adult.

[00:16:52] Speaker 01:
It was two months later.

[00:16:54] Speaker 01:
were serious.

[00:16:55] Speaker 01:
I mean, they were worse than they saw in seizures.

[00:16:59] Speaker 01:
There would still be people who did not have this fibril seizure.

[00:17:02] Speaker 01:
So the connection was made.

[00:17:04] Speaker 01:
And the connections indicated that the situation was worse because of the first fibril seizure.

[00:17:10] Speaker 01:
And that's what we see in today's syndrome across the board.

[00:17:14] Speaker 01:
They have the fibril seizure, which would normally be something that a lot of kids have with no effect at all.

[00:17:20] Speaker 01:
But then all hell breaks

[00:17:23] Speaker 05:
I understood, Ms.

[00:17:26] Speaker 05:
Collison, to be making the following point.

[00:17:30] Speaker 05:
And if I understand it correctly, it was that Dr. Raymond said,

[00:17:37] Speaker 05:
that on the Dutton study didn't involve Gervais syndrome, but a different seizure disorder.

[00:17:46] Speaker 05:
And that's at least one reason not to draw an inference for the current case.

[00:17:53] Speaker 05:
Is that correct as a description of what Dr. Raymond said?

[00:17:57] Speaker 01:
Dr. Raymond broke down Gervais syndrome into numerous

[00:18:03] Speaker 01:
categories based upon what happened.

[00:18:06] Speaker 01:
Of course, how he did it, we don't know.

[00:18:08] Speaker 01:
But that was his opinion.

[00:18:09] Speaker 01:
And he thought that this didn't specifically deal with exactly the type of Gervais syndrome that this child had.

[00:18:17] Speaker 01:
And I don't know where he gets this.

[00:18:19] Speaker 01:
A lot of his statements are not supported by anything except him.

[00:18:24] Speaker 01:
And I think that's one of the problems with Dr. Raymond and why we're always a little bit happy to see him there.

[00:18:29] Speaker 01:
But in this case,

[00:18:31] Speaker 01:
They were studying seizure disorders across the board.

[00:18:34] Speaker 01:
They didn't identify with Dravet syndrome.

[00:18:37] Speaker 01:
It was seizure disorders in children after a fibril seizure, because that was a common pattern.

[00:18:44] Speaker 01:
But the Dravet syndrome, what happened here, they saw these seizures after the fibril seizure were serious.

[00:18:53] Speaker 01:
In other words, they weren't just more seizure.

[00:18:55] Speaker 01:
They were bad.

[00:18:57] Speaker 01:
And that was why.

[00:18:59] Speaker 01:
This is a connection, because this is what happens.

[00:19:01] Speaker 01:
There is a verbal seizure that almost doesn't get noticed.

[00:19:06] Speaker 01:
And then it falls apart.

[00:19:10] Speaker 01:
And that's where this child is now.

[00:19:14] Speaker 03:
Thank you.

[00:19:14] Speaker 03:
Thank you.

[00:19:14] Speaker 03:
We thank both sides.

[00:19:15] Speaker 03:
The case is submitted.

[00:19:16] Speaker 03:
That concludes our proceedings at this moment.