[00:00:07] Speaker 03:
We have three cases set for oral argument this morning.

[00:00:14] Speaker 03:
We also have three cases that were submitted on the briefs.

[00:00:18] Speaker 03:
The first case is Pollock v. HSS.

[00:00:22] Speaker 03:
Mr. Numeroff, did I pronounce your name correctly?

[00:00:26] Speaker 01:
Yes, that's correct, Your Honor.

[00:00:27] Speaker 03:
Okay, and you're resuming five minutes for rebuttal, is that correct?

[00:00:30] Speaker 03:
Yes, Your Honor.

[00:00:31] Speaker 03:
All right, you may proceed.

[00:00:33] Speaker 01:
May it please the Court, Patrick Numeroff on behalf of the Secretary of Health and Human Services.

[00:00:38] Speaker 01:
The special master here reasonably concluded, after a thorough review of the record in this case, that petitioners had failed to prove by preponderance of the evidence that the medical condition of their son, KP, was caused by his one-year vaccination.

[00:00:54] Speaker 01:
That finding is subject to the most deferential review possible.

[00:00:59] Speaker 01:
As long as the special master considered the relevant evidence, drew plausible inferences and reasonably explained his findings,

[00:01:06] Speaker 01:
that the Court of Federal Claims was required to uphold his decision.

[00:01:11] Speaker 01:
In reversing his decision, the Court of Federal Claims applied the wrong standard of review.

[00:01:15] Speaker 01:
It instead reweighed the evidence de novo and instituted its own findings.

[00:01:21] Speaker 01:
Because that was an error, that decision should be reversed and the Special Master's findings should be reinstated.

[00:01:28] Speaker 01:
Now, in concluding that petitioners had not met the burden of proof, the Special Master looked to their medical theory

[00:01:36] Speaker 01:
and compared that to what actually occurred in KP's case and found that his medical condition did not deteriorate in the manner predicted by their theory.

[00:01:45] Speaker 02:
Didn't Judge Leto find that the Special Master mischaracterized Dr. Fry's medical theory?

[00:01:52] Speaker 01:
That is what the Court of Federal Claims found, but the Special Master's interpretation of medical theory was certainly supported by the evidence.

[00:02:01] Speaker 01:
So what Dr. Fry testified was that there are two different timeframes.

[00:02:04] Speaker 02:
Did Dr. Fry say there's some rigid three-week rule for narrow generation?

[00:02:10] Speaker 01:
What he said was that there would be an initial setback.

[00:02:13] Speaker 01:
And what he actually said was that it would occur probably within a week of the inciting event.

[00:02:19] Speaker 01:
That's at page 349 of the record.

[00:02:21] Speaker 02:
And we had a week-long fever here, right?

[00:02:24] Speaker 01:
No, Your Honor.

[00:02:25] Speaker 01:
What we had was daycare records that showed a fever two days after the vaccine

[00:02:29] Speaker 01:
then didn't show any fever, and then showed a fever nine days after the vaccine.

[00:02:34] Speaker 01:
And both of those fevers, I should say, were around 101 degrees.

[00:02:38] Speaker 01:
And what the Special Master reasonably concluded was that that wasn't the sort of dramatic setback that was predicted by Dr. Fry's theory, in part because it wasn't two or three consecutive days of fever.

[00:02:50] Speaker 01:
It was one day.

[00:02:50] Speaker 02:
I thought Dr. Fry said there would be some initial onset of some symptoms in that first week or so, but it wasn't

[00:03:00] Speaker 02:
expected there to be something dramatic?

[00:03:02] Speaker 01:
Well, if you look at the studies that Dr. Fry relied on and the example that Dr. Fry gave, you do see something more dramatic.

[00:03:08] Speaker 01:
So, for example, if you look at the Edmunds article that talked about neurodegeneration after an infection, there, what that article looked to was motor and language delay, stroke episodes, deafness, and other symptoms.

[00:03:23] Speaker 01:
If you look at the Schaffner article, that was, of course, an actual autistic regression within two weeks.

[00:03:29] Speaker 01:
And then finally, Dr. Frye gave the example of hemipolein.

[00:03:32] Speaker 01:
And there, she lost the ability to climb stairs within six days of the vaccination.

[00:03:36] Speaker 03:
Well, I saw Dr. Frye's theory as not requiring a continuous, a downward trend, but rather a progressive trend, which means that some days can be better than others.

[00:03:48] Speaker 03:
And the progressive trend is consistent with the facts of the case, are they not?

[00:03:54] Speaker 01:
I don't think so, Your Honor, but first to his medical theory, the Special Master reasonably concluded that it did predict a continuous downward spiral, and that was because Dr. Frye himself described his medical theory as predicting a downward spiral that gets worse and worse over time.

[00:04:10] Speaker 03:
That's a progressive.

[00:04:12] Speaker 03:
Isn't that a progressive spiral or progressive trend?

[00:04:17] Speaker 01:
Well, that's right, Your Honor.

[00:04:21] Speaker 01:
There is certainly predicted that KP's condition would get worse and worse after the vaccination.

[00:04:26] Speaker 01:
And what the special master concluded in looking at the evidence is that really his condition fluctuated, largely stayed the same for at least two or three months after.

[00:04:36] Speaker 02:
Go ahead.

[00:04:36] Speaker 02:
OK.

[00:04:37] Speaker 02:
I think the point that Judge Leto was trying to make was that it appeared that the special master put his own gloss on Dr. Fry's theory to the extent that the special master seemed to expect

[00:04:50] Speaker 02:
that every day KP would be worse than the prior day.

[00:04:56] Speaker 02:
Some kind of, that kind of downward spiral where Dr. Fry's testimony and theory was really more about an overall trend going downward.

[00:05:07] Speaker 02:
And that can account for the fact that sometimes sick people feel a little bit better on one day than they did the prior day, but ultimately the overall trend

[00:05:15] Speaker 02:
is definitely going down.

[00:05:17] Speaker 02:
And that's what we have here, right?

[00:05:20] Speaker 02:
Nobody's disputing that between January 2005 and July 2005, KP was on a downward trend, right?

[00:05:30] Speaker 01:
Well, KP was certainly worse in July 2005, but I think what the special master reasonably concluded was that he was not on a downward trend through those first three months after the vaccination.

[00:05:42] Speaker 01:
If you look at the actual evidence, we have

[00:05:44] Speaker 01:
the daycare records.

[00:05:45] Speaker 03:
That's because it seems to me that the Special Master is requiring that each day be worse than the preceding day.

[00:05:54] Speaker 01:
I don't think so, Your Honor.

[00:05:55] Speaker 01:
It's true the Special Master is looking at reports on a day-by-day basis, but that's the evidence the Special Master has to look for.

[00:06:02] Speaker 01:
Now, if KP's condition had been steadily getting worse and there was one or two days where KP looked like his condition was better, I think the Special Master very well may have reached a different conclusion.

[00:06:12] Speaker 01:
But if you look at it here,

[00:06:14] Speaker 01:
What we have is the daycare records, which we only have a small sliver because petitioners didn't submit any other daycare records.

[00:06:20] Speaker 03:
He called it a progressive hill downward.

[00:06:23] Speaker 03:
Those are the words Dr. Fry used.

[00:06:28] Speaker 03:
A progressive hill downward.

[00:06:29] Speaker 03:
And hills have bumps, correct?

[00:06:32] Speaker 03:
I mean, you can encounter a bump as you're headed downhill.

[00:06:38] Speaker 01:
The Special Master was not simply looking at mere bumps in the road and saying this is inconsistent with Dr. Fry's theory.

[00:06:44] Speaker 01:
So Special Master was looking at all of the evidence and finding that KP was not suffering this downward slope at all for several months after the vaccination.

[00:06:53] Speaker 01:
So the first thing to compare is if you look before the vaccination, KP was already suffering symptoms of neurodegeneration.

[00:07:01] Speaker 01:
He had been evaluated by kids as having delayed motor development and delayed speech development.

[00:07:07] Speaker 01:
His doctor had found ankle pain.

[00:07:09] Speaker 03:
This was an aggravated case, so obviously there was a pre-existing condition to the

[00:07:13] Speaker 03:
to the vaccination.

[00:07:15] Speaker 01:
Well, the pre-existing condition the petitioners point to is the mitochondrial defect, not prior neurodegeneration.

[00:07:21] Speaker 01:
But in any event, if you compare that condition, in the fall, in November and December, KP went to the doctor six times for ear infection and a rash.

[00:07:33] Speaker 01:
After his vaccination, he didn't see a doctor again until March.

[00:07:37] Speaker 01:
And then there was no notations about his developmental delay.

[00:07:42] Speaker 02:
K.P.

[00:07:43] Speaker 02:
did go see that chiropractor like ten times in February and the chiropractor said that it's in the note that K.P.

[00:07:52] Speaker 02:
was spastic.

[00:07:53] Speaker 02:
So, I mean, it's a little bit of an overstatement to suggest that all was well with K.P.

[00:07:59] Speaker 02:
during January, February, and March when the parents clearly were very concerned about its development, its delayed development, and was trying to help their child by

[00:08:11] Speaker 02:
taking him to a chiropractor throughout all of February.

[00:08:14] Speaker 02:
And then the chiropractor sees pretty significant symptoms, spastic.

[00:08:20] Speaker 02:
And it appeared that the special master just completely ignored everything the chiropractor did based on a misunderstanding of a chiropractor note.

[00:08:30] Speaker 02:
And the special master, as you agree, incorrectly believed that the chiropractor was suggesting that there's no connection between the vaccination and

[00:08:40] Speaker 02:
the kid's current condition?

[00:08:42] Speaker 01:
Well, I think there are a couple of questions regarding the chiropractors notes, and I'd like to address each of them.

[00:08:46] Speaker 01:
First, with respect to the notation that KP was fast sick 23 days after his vaccination, the Special Master gave three very reasonable reasons why that wasn't strong evidence that he was suffering neurodegeneration or a downward decline.

[00:09:03] Speaker 01:
The first

[00:09:04] Speaker 01:
was that spasticity, as Dr. Fry testified, is closely related to increased tone in your muscles.

[00:09:11] Speaker 01:
And KP had already been diagnosed with increased tone before his vaccination.

[00:09:16] Speaker 01:
The second, as the special master noted in several places, and as Dr. Snodgrass testified, the chiropractor is not qualified to diagnose spasticity in the way that a neurologist is.

[00:09:27] Speaker 01:
And the third is that even after that notation appears spastic,

[00:09:31] Speaker 01:
Two days later, or three days later, the chiropractor noted that he was doing better, that he was happier, he was more comfortable on all fours, that he was less stiff.

[00:09:40] Speaker 01:
That was over several days.

[00:09:41] Speaker 01:
So the chiropractors' notes themselves suggest that KP may have had a bad day that day, but then he had several good days afterwards.

[00:09:49] Speaker 01:
So they don't show this sort of downward slope that Dr. Fry's medical theory would have predicted.

[00:10:00] Speaker 01:
With respect to the notation about whether vaccines were the cause, at the very least, the special master was correct that the chiropractor did not suggest that vaccines were a cause.

[00:10:13] Speaker 01:
All that notation shows that KP's social worker had brought up the possibility that vaccines were a cause.

[00:10:19] Speaker 01:
There's no indication that the chiropractor agreed.

[00:10:21] Speaker 01:
There's also no indication throughout any of the other records that any other of KP's medical providers thought that vaccinations might have been a cause

[00:10:30] Speaker 01:
of this neurodegeneration.

[00:10:32] Speaker 01:
And in fact, KP's own parents gave contemporaneous accounts that did not suggest that the vaccines were a cause.

[00:10:38] Speaker 01:
They indicated that he started to regress around 11 months old before his vaccinations, and that he then got worse again in April after that MRI.

[00:10:48] Speaker 01:
And if it's okay, I'd like to reserve my remaining time for a while.

[00:10:58] Speaker 01:
Ms.

[00:10:59] Speaker 01:
Yorkland.

[00:11:08] Speaker 00:
May I proceed?

[00:11:09] Speaker 00:
Yes.

[00:11:09] Speaker 00:
If it please the court, counsel.

[00:11:12] Speaker 00:
My name is Sheila B. Yorkland and I represent Doug and Rhonda Pollock who are parents of a now 11-year-old boy who was severely injured in 2005 through receipt of childhood vaccines.

[00:11:26] Speaker 00:
I think the overarching backdrop to the two issues before this Court this morning is that the Vaccine Act is a remedial piece of legislation.

[00:11:38] Speaker 00:
As this very Court has stated, as a remedial legislation, the Vaccine Act should be construed in a manner that effectuates the underlying spirit and purpose of the Act.

[00:11:53] Speaker 00:
Congress explicitly established the vaccine program as an alternative to the traditional civil tort system, which was not working.

[00:12:04] Speaker 03:
It wasn't working for vaccine manufacturers, and it clearly was not working for persons injured... So in this case, attorney, your client was required to show by promise of evidence several elements.

[00:12:16] Speaker 03:
Do you want to get to that part of your case?

[00:12:19] Speaker 00:
I would be happy to.

[00:12:20] Speaker 00:
and also to address some of the comments that Mr. Nemiroff made.

[00:12:26] Speaker 00:
Judge Leto was given explicit authority under the enabling statute to be the checks and balance as to the special master in regards to whether or not a petitioner has met the preponderance of evidence as required by the statute.

[00:12:43] Speaker 02:
But it's not de novo review, right?

[00:12:46] Speaker 02:
In fact, it's just about the highest

[00:12:48] Speaker 02:
level of deference that you can give?

[00:12:51] Speaker 00:
Well, this Court has said the Special Master is to be accorded deference.

[00:12:56] Speaker 00:
This Court is not a rubber stamp of the Special Master's decisions.

[00:13:01] Speaker 00:
The Court of Federal Claims has given explicit authority to review the record as a whole and to determine whether or not the Special Master has made findings of fact that are based upon the relevant evidence of record.

[00:13:16] Speaker 00:
We can get to that in a minute.

[00:13:18] Speaker 00:
ample explanation by Judge Leto where Special Master did not consider relevant evidence that was of record in reaching his... So could you identify the specific errors that the Special Master made that just didn't have any plausible basis?

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

[00:13:37] Speaker 00:
First of all, the Special Master concluded that KP had evidence of central nervous system dysfunction prior to the receipt of his vaccine.

[00:13:46] Speaker 00:
As Judge Zoloto said, that was based on extremely thin evidence.

[00:13:51] Speaker 00:
Special Master based his evidence on what he determined was his own diagnosis, particularly the statement he made of language delay absent some other known cause is inherently evidence of a central nervous system disorder.

[00:14:12] Speaker 00:
That was not evidence of record.

[00:14:13] Speaker 00:
There was no testimony by either of the experts in this case that Carl's language, flight language delay, he was just slightly delayed when he was evaluated by kids in October of 2004 in his language.

[00:14:28] Speaker 00:
That is not evidence of central nervous system dysfunction.

[00:14:32] Speaker 00:
Special Master made that statement without evidence of testimony in the record.

[00:14:37] Speaker 00:
with no evidence of medical literature to support such a statement, he just pulled it out of the air.

[00:14:44] Speaker 00:
Second example where Special Master made error.

[00:14:51] Speaker 00:
The interpretation of the chiropractic record, contrary to what Mr. Nemirov said, the respondent in this case agreed that the Special Master had totally misinterpreted the chiropractic records, particularly the telephone conversation

[00:15:05] Speaker 00:
between the chiropractor and a social worker involved in this case.

[00:15:10] Speaker 00:
It was not the social worker who suggested that there may have been some kind of vaccine reaction here.

[00:15:17] Speaker 00:
It was the chiropractor who brought that up to say, there is no evidence of child abuse is what the social worker was alluding to in her conversation with the chiropractor.

[00:15:28] Speaker 00:
But the chiropractor says, no, there is potentially vaccine reaction.

[00:15:34] Speaker 00:
cerebral palsy, some kind of tumor that's going on, something much more serious.

[00:15:41] Speaker 00:
Special Master disregarded the chiropractor's finding of spasticity, pretty much based on Dr. Snodgrass's ipsy dips it type of statement of, well, I don't think chiropractors are qualified to make a diagnosis of spasticity.

[00:15:59] Speaker 00:
Chiropractors deal with muscle, deal with

[00:16:04] Speaker 00:
tendons deal with the musculoskeletal aspect of the human body every day in their practice.

[00:16:10] Speaker 00:
They are very well qualified to identify spasticity.

[00:16:13] Speaker 03:
Are they qualified to offer a medical opinion?

[00:16:17] Speaker 00:
They're not a medical doctor, but neither is the special master, and the special master cannot offer a medical opinion either, which the special master attempted to do here.

[00:16:27] Speaker 00:
As Dr. Fry testified, on a continuum, spasticity falls here.

[00:16:34] Speaker 00:
slight increase in muscle tone falls here.

[00:16:37] Speaker 00:
In January of 2005, when KP received his vaccines, he was noted to have a slight increase in muscle tone, perhaps two beats of clonox, which Dr. Fry testified were really insignificant findings in January of 2005.

[00:16:56] Speaker 00:
But within six weeks, to have a child who is spastic, who is

[00:17:02] Speaker 00:
crying when touched.

[00:17:05] Speaker 00:
That shows very rapid progression of something going on within the central nervous system.

[00:17:13] Speaker 00:
Thirdly, error that Special Master made.

[00:17:17] Speaker 00:
It was the improbable conclusion that the only reason Dr. McDonough, the treating pediatrician, sent KP to a neurologist in March was because he was frustrated with the Pollux for not having taken him to

[00:17:31] Speaker 00:
occupational therapy or physical therapy.

[00:17:34] Speaker 00:
You will note in the records that were submitted as part of the appendix that the chiropractor notes that Carl had been receiving PT and OT since December of 2004.

[00:17:47] Speaker 00:
Not on a everyday basis, but he had been attending.

[00:17:53] Speaker 00:
He was seeing the chiropractor because the parents thought that there was a musculoskeletal reason that was impeding his development as far as

[00:18:01] Speaker 00:
sitting, standing, et cetera.

[00:18:06] Speaker 03:
I'd like for you to address the issue of temporal proximity and especially the Edmonds paper and its implication on that issue.

[00:18:17] Speaker 00:
Dr. Fry's theory was that there will be an immune response following the receipt of the vaccine.

[00:18:26] Speaker 00:
That immune response, as evidenced by fever, which Carl had,

[00:18:31] Speaker 00:
He had fever two days post-vaccination.

[00:18:34] Speaker 00:
He had fever later on, I believe it was January 21st, 21st and 31st after vaccination.

[00:18:42] Speaker 00:
But that is evidence of intracellular activity evidencing immune reaction, immune response.

[00:18:50] Speaker 00:
That then sets into action intracellular activity that will lead to cellular death, which will then lead to a clinical picture

[00:19:01] Speaker 00:
evidencing the neurodegeneration, but that won't happen for weeks after the initial immune responses noted.

[00:19:09] Speaker 00:
Dr. Snodgrass, respondents, experts agreed that you would see evidence of the neurodegeneration in a few weeks.

[00:19:19] Speaker 00:
That's exactly what we had here.

[00:19:21] Speaker 00:
We had CARO with fever, day two, day nine after the vaccination.

[00:19:27] Speaker 00:
We had CARO with irritability, and then

[00:19:31] Speaker 00:
Exactly three weeks and one day after he received his vaccine, we have him noted by the chiropractor to be spastic.

[00:19:41] Speaker 00:
None of the other physicians who had seen Carl over the previous month had noted any spasticity in this child.

[00:19:49] Speaker 00:
Now the Edmonds paper

[00:20:00] Speaker 00:
The Edmonds paper was dealing with ENT type of conditions in children with mitochondrial disease and what kind of a risk infection may pose to degeneration of those children's development.

[00:20:20] Speaker 00:
The Edmonds paper, however, did show that neurodegeneration was evident

[00:20:27] Speaker 00:
Neurodegeneration events were preceded by infection in 13 out of 18 patients.

[00:20:34] Speaker 00:
These were children with already noted mitochondrial disorders.

[00:20:39] Speaker 00:
Carl was undiagnosed at the time he received his vaccines.

[00:20:45] Speaker 00:
This paper also said the timing of infections

[00:20:48] Speaker 00:
In most of the patients, 10 out of 13, the neurologic events occurred three to seven days after the onset of infection and frequently appeared at a time when the infection was resolving.

[00:21:03] Speaker 00:
Carl had fever and irritability.

[00:21:06] Speaker 00:
He had not been an irritable child before.

[00:21:09] Speaker 00:
As Dr. Fry testified, that was evidence of an encephalopathy, that something was going on in his brain.

[00:21:16] Speaker 00:
He wasn't as old as some of the children in the Edwards paper, so he had not yet acquired some of the skills that they lost, which was also what Dr. Fry alluded to when he was comparing the Hanna-Pauling case to what had happened with KP Sear.

[00:21:32] Speaker 00:
KP became spastic.

[00:21:34] Speaker 00:
He had increased tone as we went from February to July.

[00:21:40] Speaker 03:
He went from functioning at just about a 12-month level to a 12-month... So the Special Master used the Edmonds paper to set a three-week parameter, an outer bound, and much of the evidence that you rely on is outside of that three-week period.

[00:21:58] Speaker 03:
Now, when I look at the Edmonds paper and I look at the size of the population,

[00:22:03] Speaker 03:
the universe that's used to support the date and the conclusions in that paper, it doesn't seem to me to be of a sufficient size.

[00:22:15] Speaker 03:
Do you have any comment on that?

[00:22:16] Speaker 00:
As Judge Leto very correctly stated in his first opinion and then his final decision in this case,

[00:22:26] Speaker 00:
The entire area of mitochondrial dysfunction and how persons with mitochondrial dysfunction may be affected by immunization or other stressors such as infection, et cetera, was a relatively new area of study in medicine and science at the time that this case was tried and at the time that the Edmonds paper came out.

[00:22:47] Speaker 00:
What Dr. Fry said is that this just shows us that persons who have dysfunction in mitochondrial

[00:22:55] Speaker 00:
in their mitochondrial cells can be affected by infection.

[00:23:00] Speaker 00:
It's a bell curve.

[00:23:01] Speaker 00:
Some might be affected at this point.

[00:23:03] Speaker 00:
Some might be affected over at this point.

[00:23:06] Speaker 00:
Some, the bell, happened to be in the middle, which was the three to seven days.

[00:23:11] Speaker 00:
Judge Leto said that it was not appropriate to set a hard and fast boundary in this area of medicine that was just emerging and under continued scientific study.

[00:23:23] Speaker 00:
But Judge Leto said there was evidence of infection, which both experts here agreed was evidence of immune activation within the time frame.

[00:23:36] Speaker 00:
Whether you want to take Special Master's first time frame of two weeks or his later time frame of three weeks, Carl clearly fit within either of those time frames for evidencing immune response.

[00:23:50] Speaker 00:
And that immune response was the fever.

[00:23:52] Speaker 00:
and the irritability that he was expressing.

[00:23:55] Speaker 00:
I don't know if the court wants to go into any of the other argument as far as the timing issue here.

[00:24:05] Speaker 00:
No.

[00:24:05] Speaker 00:
Okay.

[00:24:13] Speaker 00:
Judges of the Court of Federal Claims are explicitly given the authority

[00:24:20] Speaker 00:
under the Act, and it's Section 12E1V, to set aside any findings of fact or conclusions of law of the special master, which are found to be arbitrary, capricious, and abuse of discretion.

[00:24:34] Speaker 00:
If the Court of Federal Claims determines that the findings are arbitrary, capricious, and abuse of discretion, or not in accordance with the law, the statute then requires them

[00:24:46] Speaker 00:
to look at the record as a whole and to come up with their own, to make their own findings of fact and reach their own conclusions based on that record.

[00:24:56] Speaker 00:
That is exactly what Judge Leto did here.

[00:25:00] Speaker 00:
He determined that the special master's findings were arbitrary, I gave you some examples, I have more if you'd like, and determined they were not in court with the law and he was required then to re-look at the evidence

[00:25:12] Speaker 00:
and to come up with his own findings, the facts, and conclusions.

[00:25:15] Speaker 00:
That's not an impermissible reweighing of the evidence, as would be suggested by Mr. Nemiroff.

[00:25:22] Speaker 00:
He did exactly as he was required to do.

[00:25:30] Speaker 00:
In establishing the vaccine program in the Office of Special Masters, Congress said, as was underscored by the Supreme Court in Brucewitz,

[00:25:40] Speaker 00:
the special master is an adjunct to the court.

[00:25:45] Speaker 00:
As this court recently said, a special master cannot manipulate the analysis in a manner calculated to arrive at a conclusion that he or she has already reached.

[00:25:57] Speaker 00:
That was a decision by this court in the Cohen case, which was decided December 4th, 2014.

[00:26:04] Speaker 00:
This is precisely what the special master did here.

[00:26:07] Speaker 00:
He had a preconceived

[00:26:09] Speaker 00:
notion on how this case should be determined, and he set about to analyze it to meet his conclusions.

[00:26:16] Speaker 03:
Counselor, you're out of time.

[00:26:17] Speaker 03:
Do you want to give us a concluding sentence?

[00:26:19] Speaker 00:
Concluding sentence.

[00:26:22] Speaker 00:
Judge Leto was clearly within his statutory authority in making his own findings and conclusions in this case.

[00:26:30] Speaker 00:
His findings and conclusions are based upon the record.

[00:26:33] Speaker 00:
We got it.

[00:26:34] Speaker 00:
Thank you.

[00:26:48] Speaker 01:
Thank you, Your Honors.

[00:26:49] Speaker 01:
I'd like to start back with this three-week period that was just discussed.

[00:26:54] Speaker 01:
There are two points I want to make.

[00:26:56] Speaker 01:
First, three weeks is really at the outer bound of what the evidence in the record suggested for that initial setback.

[00:27:03] Speaker 03:
I already discussed the article.

[00:27:04] Speaker 03:
The three-week period was established on the basis of the Edmonds paper, correct?

[00:27:09] Speaker 03:
Well, the Edmonds paper, Dr. Fry's testimony in two places.

[00:27:12] Speaker 03:
Well, let's talk about the Edmonds paper first.

[00:27:15] Speaker 03:
So there's 400 different types of mitochondrial disorders.

[00:27:20] Speaker 03:
And the Edmonds paper is based on the universe of about, what, 14 or 28 individuals?

[00:27:27] Speaker 03:
That sounds right, Your Honor.

[00:27:28] Speaker 03:
OK.

[00:27:29] Speaker 03:
Is it reasonable that that's a sufficient universe in order to make the type of conclusions that the special master arrived at?

[00:27:38] Speaker 01:
Well, the special master has to make his conclusions based on the evidence that's in the record.

[00:27:45] Speaker 01:
gave certain evidence for what their medical theory is.

[00:27:47] Speaker 01:
The Edmonds article was one large part of it, and 19 days there was at the very end of the bell curve.

[00:27:52] Speaker 01:
Dr. Fry testified.

[00:27:53] Speaker 01:
He said the event would occur within one week.

[00:27:55] Speaker 01:
Later, he implicitly accepted three weeks by saying that they had evidence to show a setback within three weeks.

[00:28:03] Speaker 01:
And the other articles and other examples showed even shorter timeframes.

[00:28:07] Speaker 01:
So all the evidence only supported that three-week time frame, and it was perfectly reasonable for the Special Master to look at that time frame.

[00:28:14] Speaker 01:
But I want to be clear, in footnote 78 of his opinion, the Special Master said that if there were a setback just after three weeks, like 23 days, 24 days, of course he would have looked at it.

[00:28:26] Speaker 01:
The only thing here that petitioners point to over and over again is this finding of spasticity by the chiropractor.

[00:28:33] Speaker 01:
But as I already discussed, there are... That was right on the outer bounds of three weeks, right?

[00:28:37] Speaker 01:
Right, but the special master discounted that finding not because it was at 23 days, but for the other three reasons that I indicated, because it was related to increased tone, because it was made by a chiropractor, and because three days later, the chiropractor said that KP was in a better mood.

[00:28:53] Speaker 01:
Two days after that, he said he was less rigid, more comfortable on all fours.

[00:28:57] Speaker 01:
And two days after that, he said he was less rigid, happier.

[00:29:00] Speaker 01:
So there was certainly sufficient evidence for the special master to conclude that that was not the sort of setback that petitioners theory predicted.

[00:29:10] Speaker 01:
Now, the other thing I want to go back to is the special master's finding of neurodegeneration even before the vaccine.

[00:29:17] Speaker 01:
Because that really illustrates that the court of federal claims is applying the wrong standard here.

[00:29:23] Speaker 01:
The special master relied there on Dr. Snodgrass's testimony.

[00:29:27] Speaker 01:
that what the kids' evaluation had found and what Dr. McDonald had found was evidence of neurodegeneration.

[00:29:33] Speaker 01:
And the Court of Federal Claims acknowledged that the finding was plausible, but said that those symptoms were not necessarily a result of a problem in the central nervous system.

[00:29:43] Speaker 01:
And for that reason, he set it aside.

[00:29:45] Speaker 01:
But that is not the proper standard of review.

[00:29:49] Speaker 01:
The Court of Federal Claims is compelled to uphold the Special Master's finding if the evidence in the record is not wholly implausible.

[00:29:57] Speaker 01:
That's at 1338.

[00:29:57] Speaker 01:
In Hazelhurst, this court said, reversible error is extremely difficult to demonstrate.

[00:30:03] Speaker 01:
All the Special Master must do is consider the relevant evidence, draw plausible inferences, and articulate a rational basis.

[00:30:11] Speaker 01:
That's certainly what the Special Master did here.

[00:30:13] Speaker 01:
And every instance in which the Court of Federal Claims attempted to find an error, really all the Court of Federal Claims was doing was reaching its own conclusion and reweighing the evidence.

[00:30:23] Speaker 01:
If there are no further questions.

[00:30:27] Speaker 03:
Thank you.