[00:00:00] Speaker 03:
Case is HL versus Department of Health and Human Services, 2017-2018.

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

[00:00:15] Speaker 01:
May it please the court.

[00:00:16] Speaker 01:
I'm here representing AI, a six-year-old girl with a mitochondrial disorder.

[00:00:24] Speaker 01:
who, which was undetected and was otherwise healthy.

[00:00:29] Speaker 01:
After being sick, received a... Well, this is a fee case, right?

[00:00:35] Speaker 01:
This is a vaccine injury case.

[00:00:37] Speaker 01:
This is a case alleging that AI was injured by a flumist vaccine, a live, attenuated influenza vaccine, and shortly after that, decompensated or dressed

[00:00:52] Speaker 01:
under the terms of a mitochondrial disorder, and less than three months later, she was dead.

[00:00:58] Speaker 04:
As I understand your theory, is that there were three factors that contributed to the decompensation, correct?

[00:01:06] Speaker 04:
The fact that she had this disease, second, that she had a respiratory infection, and third, that she received the vaccination, the flu vaccination.

[00:01:21] Speaker 04:
Yes, correct.

[00:01:23] Speaker 04:
So given that you concede that the respiratory infection was part of the causation, isn't it your burden to basically differentiate between the level of oxidative stress that was placed on her from the infection versus the vaccine?

[00:01:48] Speaker 01:
The question is, can one differentiate?

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And that's one of the issues we have with the Special Master's decision.

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The Special Master wanted our expert, Dr. Kendall, to quantify the amount of oxidative stress.

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Her position was that in the past, A.I., Alicia, had weathered and recovered from many intercurrent illnesses, including fever.

[00:02:16] Speaker 01:
No one knew she had a mitochondrial disorder.

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She was developing well.

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She had not even been to a doctor for six months prior to the visit where she got the vaccine.

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She went to the doctor because she had an upper respiratory infection.

[00:02:29] Speaker 01:
Her pediatrician determined that that upper respiratory infection had cleared.

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What happened then is the pediatrician decided to give her the Flumis vaccine.

[00:02:41] Speaker 01:
I don't think we have to respectfully differentiate

[00:02:44] Speaker 01:
our expert's opinion was that the combination of factors and the three factors, but what tipped the balance was the Flumis vaccine.

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And in fact, we rely on medical literature that was filed by the government, by the respondent, that a vaccine for children with metabolic disorders can tip the balance.

[00:03:06] Speaker 01:
And that's our argument on prong one of all fit.

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That we have put forward a medical theory

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that's recognized, that's been recognized in this court, in the Pallott case, on which compensation was granted on the mitochondrial susceptibility case.

[00:03:23] Speaker 03:
But isn't this a question of the special master determining the relative credibility of the experts?

[00:03:29] Speaker 01:
Yes, and I know the respondent relies on that.

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But our argument is that if it was simply a matter that a special master demonstrates that he considered the evidence and determined one party

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one expert is more credible than the other.

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While imposing on the petitioner a greater burden, then that's not sufficient.

[00:03:49] Speaker 01:
It's not simply a matter of fact that a special master can analyze.

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The question is, what burden did he place on the parties?

[00:03:59] Speaker 04:
So you rely heavily on the polling article, but didn't the special master find that that

[00:04:05] Speaker 04:
even if having some relevance wasn't of sufficient probative weight because it talked about something other than a metabolic disorder.

[00:04:13] Speaker 04:
It talked about autistic regression, right?

[00:04:18] Speaker 01:
Right, and we understand that the respondent focused on that and the special master focused on that.

[00:04:22] Speaker 01:
Our position is there's really no difference except for nomenclature, whether you call something an autistic regression or a decompensation.

[00:04:30] Speaker 01:
The fact is with mitochondrial disorder, the process is the same.

[00:04:34] Speaker 01:
And this case has nothing to do with autism.

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In the polling case, that regression manifested at a later time as autism.

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But the regression or the decompensation is similar.

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So they're analogous, and it's applicable for that reason.

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So our argument is that the special master's differentiation or dismissal of the polling case as not apposite is inappropriate.

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In fact, it is, and it's been recognized.

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And the fact that later the polling child

[00:05:02] Speaker 01:
was diagnosed with autism and that was a manifestation is really irrelevant.

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The question is what triggered the decompensation or the regression.

[00:05:11] Speaker 01:
I think those terms can be offered interchangeably.

[00:05:15] Speaker 04:
Isn't your problem here not so much that there might be some evidence to support your theory, but that

[00:05:24] Speaker 04:
we have to conclude that the special master acted in an arbitrary and capricious way when he concluded that that evidence to the extent it existed was outweighed by contrary evidence or that certainly your evidence didn't rise to preponderant proof.

[00:05:47] Speaker 01:
I agree that we have to focus on that issue.

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Our contention

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is that the special master inappropriately imposed on the petitioner a burden that we could never meet and therefore in the law we shouldn't have to meet.

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We don't have to present evidence of how much stress a vaccine would have caused.

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We have to show that it's reasonable under the totality of the case and this is one of our issues that we believe the special master broke down these issues in such a way that

[00:06:20] Speaker 01:
if that process is employed, even on the arbitrary and capricious standard, a petitioner could never prevail.

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Under often the field is bereft of medical knowledge that explains how vaccines cause these injuries.

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But under the totality, it was reasonable and we met the preponderance standard by showing that in a child who had a mitochondrial disorder, a child who had recently had a cleared upper respiratory infection,

[00:06:47] Speaker 01:
then got a vaccine and then had the events of decompensation.

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That that meets our burden, that we've met that burden and to impose any further requirement, which can never be met.

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No one has measured how much oxidative stress a vaccine can cause.

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What we do know in the record is that the respondents expert conceded that it has some.

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Some we don't know how much.

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And that met the burden of prong one of often to

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offer and prove a reliable medical theory.

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That was sufficiently reliable.

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The second area that the special master imposed was onset, the timing of onset.

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And the leading case, the only medical paper that discussed that was offered in the case is Edmonds.

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And we believe we're squarely within the parameters of Edmonds.

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That even if the onset was the day of,

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There's some evidence that there was onset the day of.

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That's within the parameters of evidence.

[00:07:50] Speaker 04:
Well, when you say some evidence, didn't your own experts say that the staring was the original symptom?

[00:07:59] Speaker 01:
Not precisely.

[00:08:00] Speaker 01:
She did say the evidence of the staring came from testimony from HL, the petitioner, AI's mother.

[00:08:11] Speaker 01:
And what she said is,

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If you credit that testimony, because it was not in the medical record.

[00:08:19] Speaker 01:
The testimony was that the mom did not know what staring spells were.

[00:08:24] Speaker 01:
Something happened that evening.

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But if you credit it, she would say that could be the start of it.

[00:08:30] Speaker 01:
But decompensation is not a discrete process.

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And unlike the cases cited by Respondent, where those cases discuss onset in the context of the statute of limitations,

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or meeting strict timelines for a table injury.

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That's the Markovich case and the White Cotton case.

[00:08:50] Speaker 01:
That's not what we're talking about here.

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We're talking about a totality of the process of decompensation.

[00:08:56] Speaker 01:
So it could start the evening of, that's within Edmonds, and then it could manifest in a much more dramatic way after fever that happened several days after the vaccine, 11 days later when AI had her

[00:09:11] Speaker 01:
a series of collapses that led to her eventual demise.

[00:09:19] Speaker 01:
And that's a second area we believe, we respectfully submit, that the special master elevated the burden, imposed on the petitioner, coming forward with medical literature that does not exist, and then misapplying the medical literature in an arbitrary way.

[00:09:36] Speaker 01:
It's arbitrary to say that if the onset was the evening of,

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That's too soon.

[00:09:42] Speaker 01:
It's not too soon under Edmonds, because some of those cases that were discussed in that case, in that paper, were rapid onset cases.

[00:09:52] Speaker 01:
But none the same day.

[00:09:55] Speaker 01:
Maybe not in the same day, but soon after.

[00:09:58] Speaker 01:
And to say it's the same day, that's too soon, would fall in the inflexible category that was the subject of this court's decision in power.

[00:10:07] Speaker 01:
It's a different situation, different timeline, not necessarily a hard and fast rule, but imposing a judgment on the facts that that was too soon.

[00:10:20] Speaker 01:
Why is that too soon?

[00:10:22] Speaker 01:
This child had two, no three, as Gerardo pointed out at the beginning, three stressors.

[00:10:30] Speaker 01:
And it's well known in medicine that an animistic response, we're not talking about here, but by analogy, could cause onset sooner.

[00:10:40] Speaker 01:
We don't know the answer to that, but it's reasonable that she would manifest some evidence of decompensation, but then she started to recover.

[00:10:49] Speaker 01:
And then 11 days after the vaccine, which is squarely within the parameters of Edmonds,

[00:10:55] Speaker 01:
when it makes perfect sense as a logical sequence of cause and effect, then she had the major decompensation.

[00:11:03] Speaker 01:
But it by no means undermines our position that she had some evidence on the night of, and then she was fine for a few days and appeared to recover to the point where 11 days later she could return to school when she had her clear major decompensation that she did not recover from.

[00:11:21] Speaker 01:
So in that way, we respectfully submit that the special master elevated the burden for petitioner there as well, also requiring medical literature, which does not exist and we don't have to produce under-offered.

[00:11:35] Speaker 01:
But looking at the totality, we would argue that the special master was arbitrary and capricious in imposing those kinds of requirements on the petitioner.

[00:11:50] Speaker 03:
We can save the rest of you a little time.

[00:11:53] Speaker 03:
Excuse me.

[00:11:54] Speaker 03:
Thank you.

[00:11:55] Speaker 03:
Mr. Coleman.

[00:11:59] Speaker 00:
May it please the court.

[00:12:01] Speaker 00:
My name is Robert Coleman.

[00:12:01] Speaker 00:
I represent the APLE Secretary of Health and Human Services.

[00:12:06] Speaker 00:
This is a tragic case, as petitioners council already alluded to.

[00:12:10] Speaker 00:
A.I.

[00:12:11] Speaker 00:
had a horrific condition, Lee disease, which almost inevitably leads to

[00:12:16] Speaker 00:
a very sad and tragic decompensation and eventual passing, as happened here.

[00:12:22] Speaker 00:
However, the special master thoroughly addressed all of the petitioner's arguments and reasonably concluded that on the basis of those arguments, petitioner had not met her burden to demonstrate that the vaccine played any causal role in the decompensation or eventual passing.

[00:12:39] Speaker 04:
Starting where your friend on the other side left off, I have a real hard time with the temporal analysis.

[00:12:48] Speaker 04:
I mean, there's nothing in literature that said there can't be any symptoms that appear on the day of.

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And the key symptoms did appear squarely within the Edmonds study time parameter.

[00:13:04] Speaker 04:
So to say that there's just no showing, no sufficient showing on the temporal prong,

[00:13:09] Speaker 04:
seems to me, even under the most lenient standard of view, to be kind of crazy.

[00:13:18] Speaker 00:
The first thing I would like to know about the timing mechanism is the Edmunds study that has already been alluded to dealt solely with an infection as a potential cause and gave the time frames of what would be expected after an infection, not a vaccination.

[00:13:33] Speaker 00:
So actually, there's no evidence regarding a time period pertinent to vaccination at all.

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So that's the first consideration.

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The second consideration is that although it could be argued that there, if you just take the timing and remove the fact that there's no link to vaccination, if you just took the timing element from the Edmonds case and looked solely at that, it's possible that one could argue that there is trace support for potentially having onset within hours as three of the 13 individuals studied and that study did.

[00:14:08] Speaker 00:
suffer from decompensation in the first three days or so.

[00:14:13] Speaker 00:
But simultaneously that evidence would further support infection as the cause because infection fit within the majority of the individuals studied in that particular Edmonds paper to demonstrate that the onset period as here two, three, four days onset period that we have here fits within the majority of those individuals in the Edmonds study.

[00:14:36] Speaker 04:
But you agree that she had three potential stressors, correct?

[00:14:40] Speaker 04:
All of which, under the literature, could conceivably lead to problems, including her decompensation.

[00:14:49] Speaker 00:
No, I don't agree with that, respectfully.

[00:14:51] Speaker 00:
There's no support in the literature at all for the vaccine playing a role here.

[00:14:56] Speaker 00:
So I don't believe there's really any support for that assertion.

[00:14:59] Speaker 00:
Certainly, there's clear support for the infection being.

[00:15:03] Speaker 00:
That's a known

[00:15:04] Speaker 00:
Both experts here actually completely agree that that is a known trigger of decompensation in individuals who have Lee disease.

[00:15:13] Speaker 00:
So that is certainly a factor.

[00:15:15] Speaker 00:
But both experts also agree that no identifiable trigger is even necessary.

[00:15:19] Speaker 00:
This is that tragic of a condition, unfortunately.

[00:15:23] Speaker 02:
Can you clarify something?

[00:15:24] Speaker 02:
I think Mr. Krakow referred to the infection having cleared.

[00:15:29] Speaker 02:
I think he said that.

[00:15:32] Speaker 02:
I think he was referring to at the time that the Flumis vaccine was given.

[00:15:37] Speaker 02:
Can you just clarify what the findings are and what the evidence is in that regard?

[00:15:44] Speaker 00:
Certainly.

[00:15:45] Speaker 00:
So at the time that AI was administered the Flumis vaccine,

[00:15:51] Speaker 00:
she had a temperature of 100.3.

[00:15:53] Speaker 00:
Earlier in the day she had a temperature of 100.2 and her symptoms have been reported, infectious illness type symptoms for the previous couple days.

[00:16:03] Speaker 00:
So it's definitely possible that it was in the process, the illness was in the process of recovery, but certainly not fully recovered if she was at 100.3 or probably not fully recovered if at 100.3.

[00:16:18] Speaker 00:
But the Edmonds study

[00:16:20] Speaker 00:
not only indicates that the majority of individuals suffered the onset of their decompensation in the three to seven day window after infectious insult, but also at the same time that the infection was resolving.

[00:16:34] Speaker 00:
So that's perfectly consistent with an infection being a trigger, that timing mechanism there.

[00:16:41] Speaker 00:
And to address your point more specifically, I think resolving would probably be an accurate way to put it.

[00:16:48] Speaker 02:
resolving as a process rather than cleared as a completed phenomenon.

[00:16:52] Speaker 00:
I think that's accurate.

[00:16:55] Speaker 04:
So the polling information, part of what the polling study, part of what my problem is, is that the study doesn't say that the wild flu virus could only have an effect

[00:17:13] Speaker 04:
on someone whose ultimate regression has to do with autism, it says that the wild flu virus can be a trigger.

[00:17:22] Speaker 04:
So why is that completely irrelevant?

[00:17:26] Speaker 00:
There are a number of reasons why that's of little to no evidentiary value here.

[00:17:31] Speaker 00:
And I think, first and foremost, autistic regression, as Dr. McCandless, a respondents expert, testified in this case, autistic regression is something altogether different.

[00:17:41] Speaker 00:
from metabolic decomposition that we're dealing with here.

[00:17:43] Speaker 00:
So that's the first reason why it doesn't necessarily.

[00:17:47] Speaker 04:
Of course.

[00:17:48] Speaker 04:
If the wild flu vaccine can be a trigger for illnesses, there might be different illnesses that would result.

[00:17:54] Speaker 04:
But that doesn't mean it doesn't, that there isn't an indication that the wild flu vaccine can be dangerous.

[00:18:02] Speaker 00:
Potentially.

[00:18:03] Speaker 00:
But as the special master indicated, it's not

[00:18:06] Speaker 00:
sufficient for purposes of determining whether a petitioner has met preponderant evidence, the preponderant evidence standard here, to say that a certain vaccine or an infection causing X is the same as an infection causing Y or the vaccine causing Y, unless X and Y can be shown to have sufficient commonality to draw that conclusion.

[00:18:29] Speaker 00:
So here, although perhaps in some abstract sense it could provide some trace evidence,

[00:18:36] Speaker 00:
It's not actually pertinent to the individual here and it's not pertinent to the condition that was suffered here.

[00:18:42] Speaker 00:
So that's why I believe the special master found that it was simply

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not supportive of petitioners' claim.

[00:18:49] Speaker 04:
What's your response to the argument that when you're talking about something like Lay's disease that is extremely rare and there is no science, no hard science with respect to all the triggers for the decompensation, aren't you putting a burden on the petitioner to basically prove the unknown?

[00:19:12] Speaker 00:
I don't believe so.

[00:19:13] Speaker 00:
I think the special master here in this particular case gave every opportunity to petitioner to prove her case primarily through circumstantial means.

[00:19:22] Speaker 00:
On page 27 of the special master's decision and which is page 27 of the appendix, the special master specifically indicated that petitioner here, petitioner's expert Dr. Kendall was attempting to put forward a circumstantial case and that that is completely permissible under the Vaccine Act.

[00:19:41] Speaker 00:
completely willing to consider that.

[00:19:43] Speaker 00:
He then went through thoroughly each of the arguments put forth by Dr. Kendall, the circumstantial arguments, to address if any of those had any particular support for Petitioner's position, and he simply found that they did not.

[00:19:57] Speaker 00:
But I think he gave every opportunity to Petitioner to prove her case, even though it's understood that the science is in its infancy here regarding this issue.

[00:20:07] Speaker 00:
But that, of course, also is why the burden is only preponderant evidence to take that into consideration as well, that petitioners should not be held to any higher burden than that to attempt to make their case.

[00:20:20] Speaker 02:
Can you address something that I think I also heard Mr. Krakow say, that something to the effect that while autism is a different consequence of a certain kind of

[00:20:36] Speaker 02:
insult that affects the mitochondria, that there's a common mechanism of action between this case and the autism case discussed in the literature.

[00:20:53] Speaker 00:
Yes, certainly.

[00:20:53] Speaker 00:
And I believe that was addressed at least in part on page 20 of the appendix, footnote 15, where the special master

[00:21:03] Speaker 00:
addresses Dr. McCandless addressing this type of issue and says that although the mechanism of autistic regression is not known, the regression and mitochondrial decomposition in Lee disease results in nerve loss that's visible on the MRI.

[00:21:20] Speaker 00:
This is the kind of thing that is picked up on in imaging and clearly some different mechanism is at play here.

[00:21:28] Speaker 00:
So I believe it would be inaccurate to say that we have the same

[00:21:32] Speaker 00:
underlying or initial triggering mechanism happening in autism as we would in a situation like Lee disease where clearly the manifestation is different at times early in the going when this is starting to develop and when particularly regarding autism very little is known about what the mechanism is.

[00:21:55] Speaker 00:
and Dr. McAnlis is testifying to that fact.

[00:21:58] Speaker 00:
So I think certainly, I think that Dr. McAnlis clarified it there and I think as well that the special master's drawing of inferences from that are at a minimum plausible, if not correct, and therefore respond respectfully to request that this court affirm.

[00:22:19] Speaker 04:
Didn't Dr. McAnlis

[00:22:21] Speaker 04:
concede that a fever increases metabolic need and that therefore, that's one of the reasons that they don't recommend flu vaccines to anyone who's got any kind of illness, right?

[00:22:34] Speaker 00:
I don't know if that's exactly why that it's contraindicated in that instance, but I do know that it is contraindicated to give certain vaccines to individuals when they are severely ill.

[00:22:47] Speaker 04:
Well, any kind of illness.

[00:22:49] Speaker 04:
Even CVS won't give you a vaccine if you're ill.

[00:22:52] Speaker 04:
Right?

[00:22:53] Speaker 00:
I believe this was addressed to a small degree in the testimony here, and that neither expert said that it was improper to administer the vaccine in this instance.

[00:23:04] Speaker 00:
And AI had a wonder.

[00:23:05] Speaker 00:
Right.

[00:23:06] Speaker 04:
But Dr. McAnus conceded that administering a vaccine in this instance, whether it's improper or not, could increase the risk.

[00:23:14] Speaker 00:
I don't believe that he

[00:23:15] Speaker 00:
I don't believe that he conceded that.

[00:23:17] Speaker 00:
No, I think he said that it's possible that it would cause some uptick in metabolic need, but Dr. Kendall illustrates this point perfectly in the transcript where she said that metabolic demand, an increase in metabolic demand is something that happens all the time.

[00:23:35] Speaker 00:
I think this is something that happens with almost everything that we do, and that's kind of what Dr. Kendall, petitioner's expert, is testifying there too.

[00:23:45] Speaker 00:
Dr. McCandless indicated that, yes, it's possible that the vaccine will cause some uptick in metabolic need.

[00:23:50] Speaker 00:
It just demonstrates his candor to the court.

[00:23:53] Speaker 00:
He then goes on to indicate not enough, in his opinion, to actually play some material role or to be any injurious factor or to bring about any particular condition he's aware of, specifically not AI's condition here.

[00:24:08] Speaker 04:
What more could the petitioner have done in these circumstances?

[00:24:13] Speaker 00:
To be honest, I don't know exactly.

[00:24:15] Speaker 00:
I think some, perhaps the case was just, perhaps the vaccine just had nothing to do with it and therefore there's no further evidence that would support the claim.

[00:24:25] Speaker 00:
And I think in some instances that just may happen.

[00:24:29] Speaker 00:
Or perhaps some different theory could have been espoused.

[00:24:33] Speaker 00:
I'm not sure about that.

[00:24:34] Speaker 00:
But all I know is that with the evidence submitted before the special master, I think he gave that every benefit of the doubt and analyzed it thoroughly and considered all the relevant evidence

[00:24:45] Speaker 00:
drew plausible conclusions, and that's why we respectfully request the court to confirm.

[00:24:50] Speaker 03:
Thank you, counsel.

[00:24:51] Speaker 00:
Thank you.

[00:24:52] Speaker 03:
Mr. Krakow has some rebuttal time, three minutes.

[00:24:57] Speaker 01:
Dr. McCandless, the respondent's expert, was pressed before he finally admitted.

[00:25:08] Speaker 01:
We would argue, conceded, that a vaccine can increase metabolic need

[00:25:15] Speaker 01:
And our argument is that that is what tipped the balance.

[00:25:18] Speaker 01:
And in fact, I want to go back to the Brady paper, a paper cited and filed by the respondent.

[00:25:26] Speaker 01:
which talked about tipping the balance, said a vaccine can cause a systemic reaction, and in children with metabolic disorders, that can tip the balance.

[00:25:38] Speaker 01:
That's exactly what we're arguing here.

[00:25:40] Speaker 03:
But Mr. Krakow, you're arguing evidence to us, whereas the factual question was for the special master.

[00:25:48] Speaker 01:
Yes, and we respectfully submit that the special master ignored that and dismissed that without properly considering it, imposing on the petitioner a higher burden.

[00:25:58] Speaker 01:
In fact, we were relying on the respondent's medical literature to show what we had to show.

[00:26:04] Speaker 01:
That meets prong one, that we have a reliable medical theory.

[00:26:08] Speaker 01:
We're relying on medical literature proffered by the respondent that says exactly what our theory is, that the vaccine tipped the balance

[00:26:18] Speaker 01:
in combination with other stressors.

[00:26:20] Speaker 01:
So it's not irrelevant that the child had an infection.

[00:26:23] Speaker 01:
It is very relevant, and that, in fact, is part of our theory.

[00:26:26] Speaker 01:
We're not arguing that we didn't have an opportunity to prove our case.

[00:26:30] Speaker 01:
We submit that we did prove our case within the requirements of ALFIN.

[00:26:34] Speaker 01:
And when a special master questions and relies on the fact that petitioners did not produce evidence that we could never produce and which, under ALFIN,

[00:26:45] Speaker 01:
the court does not require that we produce, then that's arbitrary and capricious.

[00:26:52] Speaker 01:
I would go back to the question about it was the pediatrician who determined that the infection cleared.

[00:27:02] Speaker 01:
This had happened many times with AI, and she recovered.

[00:27:09] Speaker 01:
In this case,

[00:27:10] Speaker 01:
as compared to all other cases.

[00:27:12] Speaker 02:
Even though there is a somewhat, still somewhat elevated fever?

[00:27:16] Speaker 01:
Well, I think the testimony by Dr. Kendall, and I don't think Dr. McAnlis disagreed with this, is that 100.3 is not really a fever in that context.

[00:27:28] Speaker 01:
It was slightly elevated, and the pediatrician had no problem giving a vaccine at that point.

[00:27:35] Speaker 01:
So while it may be that the infection was resolving,

[00:27:40] Speaker 01:
Now we added another stress, and that's the basis of our claim.

[00:27:44] Speaker 01:
And then the rest followed from there.

[00:27:47] Speaker 01:
On the issue, again, I think I addressed this in my opening remarks, that it makes no difference that we don't understand the process that manifests in autism.

[00:28:00] Speaker 01:
That is clearly not understood.

[00:28:02] Speaker 01:
What was clear in a case that was before this court in which polling was relied on, on the onset issue,

[00:28:09] Speaker 01:
and the Schaffner literature that we also cited, and Edmonds, and that's the Palin case, is that a vaccine can cause a regression.

[00:28:20] Speaker 01:
Our position is there is no difference in a regression and decompensation.

[00:28:24] Speaker 01:
It's different words for the same thing.

[00:28:26] Speaker 01:
It's a matter of how it manifests.

[00:28:29] Speaker 01:
And we think that's a distinction without a difference.

[00:28:33] Speaker 01:
And that, in fact, the manifestation here can be identified, because lay disease has been described in terms of

[00:28:39] Speaker 01:
brain lesions, and so on.

[00:28:41] Speaker 01:
Autism is not.

[00:28:42] Speaker 01:
But what's clear is that the process of decompensation can be triggered by a vaccine.

[00:28:47] Speaker 01:
That was established, and Palak, a compensated case that was on appeal on the onset issue primarily, in which all this literature was credited.

[00:28:57] Speaker 01:
Now, the literature was credited, and somehow it's not, Palak was not an autism case.

[00:29:03] Speaker 01:
Palak was a mitochondrial decompensation case manifesting in a different way.

[00:29:09] Speaker 03:
This is a field in which... Thank you, Mr. Krakow.

[00:29:12] Speaker 03:
Your red light has been on for a while.

[00:29:14] Speaker 01:
Thank you very much.

[00:29:15] Speaker 03:
We'll take the case under advisement.