[00:00:04] Speaker 03:
The final case for argument this morning is 18-2333, Boatman v. HHS.

[00:01:30] Speaker 00:
May it please the court.

[00:01:32] Speaker 00:
This case presents the issue of whether the Court of Federal Claims erroneously held that the special master applied a standard of proof so low as to constitute clear error, and thus committed legal error in setting aside the special master's factual findings.

[00:01:44] Speaker 02:
The Court of Federal Claims concluded that petitioners failed to satisfy Elvin, prong one, so that necessarily they failed on prong two.

[00:01:55] Speaker 02:
If we reverse on prong one,

[00:01:58] Speaker 02:
Do we have to consider, are the prong two issues on appeal at this point?

[00:02:06] Speaker 00:
I believe elfin prong one and elfin prong two are on appeal.

[00:02:10] Speaker 00:
So we would have to show elfin prong one and prong two.

[00:02:15] Speaker 00:
He did indicate that because we failed in elfin prong one, we also failed in elfin prong two.

[00:02:20] Speaker 02:
That was his total analysis of two.

[00:02:23] Speaker 02:
So if we reverse on one, do we automatically reverse on two?

[00:02:27] Speaker 02:
Or do you need to address other issues?

[00:02:32] Speaker 00:
The special master found four petitioners for Alphenprong 1, Alphenprong 2, all the Alphenprongs.

[00:02:38] Speaker 00:
And I would submit that the special master's findings should not have been overturned.

[00:02:43] Speaker 00:
And you should affirm the special master's findings on Alphenprong 2.

[00:02:46] Speaker 00:
And I don't think that needs to be revisited as well.

[00:02:49] Speaker 03:
Under Dr. Miller's theory,

[00:02:52] Speaker 03:
Any child under six months or whatever we're dealing with receiving a vaccine, irrespective of whether he or she develops a fever in the next 48 hours, if that child tragically dies of SIDS, we one, assume or accept or presume that that child had a brain stem problem.

[00:03:19] Speaker 03:
And two, that the vaccine caused the SIDS death.

[00:03:24] Speaker 03:
Isn't that what Dr. Miller's theory is?

[00:03:28] Speaker 00:
I think first we have to make sure that we exclude for other causes.

[00:03:31] Speaker 00:
And he did say we have to exclude for other causes.

[00:03:34] Speaker 00:
And the autopsy in this case did exclude other causes.

[00:03:38] Speaker 00:
So if the autopsy were to find metabolic abnormalities or something else,

[00:03:43] Speaker 00:
That could explain the SIDS death.

[00:03:45] Speaker 00:
That it wouldn't in that case, yes.

[00:03:47] Speaker 00:
That's correct.

[00:03:47] Speaker 03:
But if we have other causes, it's not SIDS, right?

[00:03:49] Speaker 03:
And SIDS is sort of the unknown cause.

[00:03:52] Speaker 00:
Depending on how severe that abnormality would be, it might be caused by the SIDS.

[00:03:58] Speaker 03:
But in the absence of finding another abnormality that would have been found to have caused the death, then automatically the use of the vaccine would be concluded as being the cause of SIDS.

[00:04:12] Speaker 00:
I think there's also the question, Dr. Miller's theory embraces the trip risk theory.

[00:04:18] Speaker 00:
So in the trip risk theory, you also have to look at other inherent vulnerabilities.

[00:04:22] Speaker 00:
So if there's other inherent vulnerabilities in which the evidence is strong, that they would predominate, or if there are other exogenous risk factors in other cases, and the evidence in those cases is strong for the other exogenous risk factors, in those cases, it could outweigh the vaccine as potential cause.

[00:04:40] Speaker 02:
So I think- So in essence,

[00:04:42] Speaker 02:
If the infant has those additional risk factors, they're male, they're African-American, their parent is a smoker.

[00:04:53] Speaker 02:
I mean, there's a whole list.

[00:04:55] Speaker 02:
Then the special master's analysis was, in that circumstance, I'm going to, using the scientific evidence, make this presumption.

[00:05:07] Speaker 00:
I think they can make that presumption.

[00:05:09] Speaker 00:
And it's important to understand that SIDS is multifactorial.

[00:05:13] Speaker 00:
And the trooperist theory embraces that, that it is multifactorial.

[00:05:17] Speaker 00:
And in this case, there were other inherent risk factors demonstrated.

[00:05:20] Speaker 00:
He was a male infant, and that's an inherent risk factor.

[00:05:24] Speaker 00:
And the special master acknowledged that that probably played a role as well.

[00:05:27] Speaker 00:
But there were other risk factors, other exogenous risk factors that he did address, such as

[00:05:33] Speaker 00:
race, African-American.

[00:05:35] Speaker 00:
He was an African-American baby.

[00:05:37] Speaker 00:
But in the literature, that is typically associated with SIDS due to either poor socioeconomic status or poor health care, which we're not present in this case, and he dismissed that as an exogenous risk factor.

[00:05:49] Speaker 03:
Dr. Miller's theory, the portion of which, I guess maybe the first step of which, is that a mild, the reason a mild infection is linked to SIDS is because of the neurochemical response to cytokines?

[00:06:06] Speaker 03:
Cytokines, yes.

[00:06:09] Speaker 03:
Rather than purely mechanical reasons.

[00:06:11] Speaker 03:
Correct.

[00:06:13] Speaker 03:
Is there some acceptance of this theory in the medical literature or elsewhere?

[00:06:18] Speaker 00:
There is.

[00:06:18] Speaker 00:
And the petition has filed several medical articles explaining how SIDS infants with mild or trivial infection.

[00:06:27] Speaker 00:
In the literature, it's infection or inflammatory process.

[00:06:30] Speaker 00:
So it doesn't necessarily have to be a trivial infection.

[00:06:33] Speaker 00:
It can be some sort of trivial inflammatory insult, such as a vaccine.

[00:06:38] Speaker 00:
And that's explicit in the literature.

[00:06:41] Speaker 00:
And these articles do describe infection or the inflammatory insult as a neurochemical risk factor.

[00:06:49] Speaker 00:
And they cite to the expression of cytokines and SIDS with mild infection or SIDS infants versus non-SIDS infants in areas of the brain that are responsible for arousal and auto resuscitation.

[00:07:03] Speaker 00:
So in the literature there is more support in the literature for mild infection or trivial infection or an inflammatory insult as a neurochemical risk factor versus mechanical risk factor and the respondents expert dr. McCusker her position was that Mild infection can only be can only act as a mechanical risk factor without citing any literature support for that so there is a

[00:07:26] Speaker 00:
And Dr. Miller also has consulted on numerous SIDS autopsies as well and testified that he has never seen an infection operate in that way as a mechanical risk factor or could have been a mechanical risk factor.

[00:07:39] Speaker 00:
So the support in this case was, in my opinion, pretty overwhelming that mild infection or inflammatory insults act as a neurochemical risk factor versus mechanical.

[00:07:50] Speaker 02:
It seems to me that what the weight of the

[00:07:56] Speaker 02:
evidence pointed to, other than a specific result in this case, was potentially an argument that when all these other factors were present, vaccines might need to be given at a later date.

[00:08:15] Speaker 02:
That seems to be where both the theories and the testimony were going, is it not?

[00:08:22] Speaker 00:
I think that's a reasonable conclusion.

[00:08:27] Speaker 03:
What does that mean?

[00:08:28] Speaker 03:
The risk factors being so males, African Americans?

[00:08:34] Speaker 02:
First four months.

[00:08:36] Speaker 02:
Correct.

[00:08:37] Speaker 03:
So that the answer to this is if they're given at a later date, then that alleviates the risk of SIDS.

[00:08:45] Speaker 03:
What is that later date?

[00:08:46] Speaker 03:
What's the literature say about six months, seven months, eight months?

[00:08:50] Speaker 00:
I think it is a reasonable hypothesis.

[00:08:53] Speaker 00:
And one of the three tenets of the trooperist theory is also a critical developmental period.

[00:08:58] Speaker 00:
And that previously had been defined as the first year of life.

[00:09:02] Speaker 00:
And the vast majority of SIDS infants occurred within that first year of life.

[00:09:07] Speaker 00:
As research has gone on and developed, that's kind of been pared down to the first six months of life, really from two to six months, and the vast majority in two to four months.

[00:09:18] Speaker 03:
OK, this is kind of, I guess,

[00:09:21] Speaker 03:
Important, I think.

[00:09:22] Speaker 03:
I mean, the charge here is there's no differentiation.

[00:09:25] Speaker 03:
This infant got five or seven shots.

[00:09:28] Speaker 03:
I couldn't keep track.

[00:09:29] Speaker 03:
But all of these shots, this entire regiment at one time.

[00:09:33] Speaker 03:
And you're suggesting that the medical evidence is such that parents should withhold the shots, any of those shots from

[00:09:46] Speaker 03:
an indeterminate amount of time beyond six months for every male, at least, and every American male?

[00:09:54] Speaker 03:
I'm not sure where you think the medical science is.

[00:09:59] Speaker 00:
I'm not saying that that should be done currently.

[00:10:03] Speaker 00:
But if the research were to develop and it was more conclusively shown, then, of course, I think it should be moved out.

[00:10:11] Speaker 03:
What is more conclusively shown?

[00:10:14] Speaker 03:
that this was the cause of SIDS, or that the cause of SIDS could be eliminated?

[00:10:21] Speaker 00:
I don't think, no, I think, and obviously we're not to that point of scientific certainty, and that's not what we're trying to show in this case.

[00:10:31] Speaker 02:
It's one insult among many potentials.

[00:10:35] Speaker 00:
Potentially, potentially correct.

[00:10:40] Speaker 03:
Can I ask you about this brainstem abnormality, because that's considered a risk factor.

[00:10:45] Speaker 03:
But in this case, it's kind of a circular thing to me, because there was an autopsy done, but this particular infant was not tested.

[00:10:54] Speaker 03:
So we don't know, except we assume.

[00:10:57] Speaker 03:
So the question answers itself.

[00:10:59] Speaker 03:
Because the child succumbed to SIDS, then we assume that that child had a brainstem abnormality.

[00:11:07] Speaker 03:
Is that the way where the science takes us?

[00:11:10] Speaker 00:
Well, I think the important thing is to focus on this case in particular.

[00:11:15] Speaker 00:
And the Special Master looked at several different things in making a determination that JB did in fact have an inherent brain stem abnormality.

[00:11:25] Speaker 00:
And you're correct.

[00:11:26] Speaker 00:
The autopsy did not show direct evidence of a brain stem abnormality.

[00:11:30] Speaker 00:
Did it look?

[00:11:32] Speaker 00:
It didn't.

[00:11:33] Speaker 00:
That section of the brain stem was not sampled.

[00:11:35] Speaker 00:
The brain stem itself was not sampled.

[00:11:38] Speaker 00:
And actually, so

[00:11:40] Speaker 00:
The evidence in this case that the special master looked at were, yes, he did look at the statistical data in the medical literature that 50% to 90% of SIDS infants have been found in the research to have an inherent abnormality.

[00:11:55] Speaker 00:
And it's not one abnormality.

[00:11:57] Speaker 00:
There are many different abnormalities that have been demonstrated.

[00:12:00] Speaker 00:
And they can be structural or functional.

[00:12:03] Speaker 00:
So assuming that a brainstem is appropriately sampled,

[00:12:07] Speaker 00:
The medical examiner may or may not find a structural abnormality.

[00:12:11] Speaker 00:
But if you apply specialized techniques that Dr. Kenney and her colleagues use in the SIDS research, in the great percentage of those cases, functional abnormalities of the brain stem have been found as well.

[00:12:25] Speaker 00:
So we looked at the statistical data.

[00:12:28] Speaker 00:
In addition, in this case, the special master found that the respondent's expert conceded that JB had a brain stem defect.

[00:12:34] Speaker 00:
in this case.

[00:12:35] Speaker 00:
So that's another thing that he looked at as well.

[00:12:38] Speaker 00:
And he also gave credit to the fact that Dr. Miller, his finding is consistent with the methodology employed by Dr. Miller when he's consulting on SIDS autopsies.

[00:12:50] Speaker 00:
And he uses Dr. Kinney's literature in his field of practice when he's doing, when he's consulting on SIDS autopsies.

[00:12:56] Speaker 03:
So... What does one make of between 50 and 90 percent?

[00:13:00] Speaker 03:
I understood the record here is that the Special Master concluded.

[00:13:07] Speaker 03:
Now, there was a concession by the other side, and I understand, and we'll ask the government about that.

[00:13:12] Speaker 03:
But in the absence of a concession, you don't make an assumption that someone had a brainstem abnormality based on a 50 to 90 percent, a variety of things, right?

[00:13:25] Speaker 00:
Well, I think in some cases that may be the best evidence there is is the statistical data.

[00:13:30] Speaker 00:
In this case, it was one of several things.

[00:13:32] Speaker 00:
But in some cases, that may be the best evidence.

[00:13:34] Speaker 00:
And the sad truth is most SIDS autopsies are not performed in a way that will show any structural abnormalities.

[00:13:42] Speaker 00:
And in this case, like a lot of cases, the brainstem isn't even sampled, let alone serially sampled.

[00:13:49] Speaker 00:
So, you know, in addition to that, a lot of times, even with appropriate sampling, the structural defect is not going to be evident.

[00:14:01] Speaker 00:
It's going to be a functional abnormality, which really, practically speaking, is only done in the research where they have the funding for those kind of methodologies.

[00:14:12] Speaker 03:
Well, the real tragedy, the problem is that you can't test it while the infant is still alive so that you can determine preventive measures.

[00:14:22] Speaker 03:
All right.

[00:14:25] Speaker 03:
Why don't we hear from the other side?

[00:14:26] Speaker 03:
We'll be staying here.

[00:14:38] Speaker 04:
Good morning, Your Honor.

[00:14:40] Speaker 04:
Good afternoon.

[00:14:41] Speaker 04:
May it please the Court?

[00:14:42] Speaker 04:
My name is Thomas Ward.

[00:14:44] Speaker 04:
I'm the Deputy Assistant Attorney General in the Civil Division for the Torts Branch.

[00:14:49] Speaker 04:
And I'd like to start by just expressing my sympathy for the family and the parents.

[00:14:54] Speaker 04:
Nobody can understand what a loss this is unless they've gone through it.

[00:14:58] Speaker 04:
And even though we disagree on the issues.

[00:15:00] Speaker 01:
Let me ask you a question about government policy in terms of administering the vaccine act.

[00:15:09] Speaker 01:
We've seen other cases in which the reasons for an adverse infant reaction to a vaccine are getting to be better understood than they had been over

[00:15:24] Speaker 01:
over history and that it's been known statistically over the decades that a very small percentage, I think one-half of 1% of infants will experience a dramatically adverse reaction to vaccine.

[00:15:44] Speaker 01:
and without being able to tell who in advance had either the genetic defect or the spinal defect that was found here by autopsy, and that the purpose of the statute was to accommodate

[00:16:00] Speaker 01:
that unknown or that propensity or that risk so that the national policy of vaccination of infants for the greater good, the greater public benefit, would not be adversely affected.

[00:16:19] Speaker 01:
And what we see here and

[00:16:22] Speaker 01:
have seen recently elsewhere is as the reason is getting to be understood, we're told, well, it was this infant's destiny.

[00:16:31] Speaker 01:
is the word that we've seen.

[00:16:34] Speaker 01:
And therefore, the Vaccine Act doesn't apply.

[00:16:38] Speaker 01:
But my understanding over the decades that we've been looking at these cases is that's directly contrary to the legislative purpose of this statute in the first place.

[00:16:52] Speaker 01:
Is this something on which that the

[00:16:54] Speaker 01:
the government or HHS or whoever it is that administers and that sees all these cases is thinking about?

[00:17:02] Speaker 01:
Should there be additional pre-vaccination tests or analyses in order to accommodate the advances of science?

[00:17:15] Speaker 01:
Or where are we in terms of this administration?

[00:17:18] Speaker 01:
Because we read in the press that there is more and more agitation

[00:17:24] Speaker 01:
about infant vaccination just because there is still this real statistical, dramatically adverse reaction as here.

[00:17:38] Speaker 01:
If the infant dies, shows a reaction within hours and dies within the day, it's very hard to say there was no relationship.

[00:17:50] Speaker 04:
We're all with that.

[00:17:53] Speaker 04:
So in terms of your policy question, the program is designed to compensate.

[00:18:00] Speaker 01:
Speak up a little, please.

[00:18:01] Speaker 04:
The program is designed to compensate fairly and efficiently.

[00:18:05] Speaker 04:
It's not designed to give away money when there is no scientific proof.

[00:18:15] Speaker 04:
that an illness or death was caused by vaccines, as in this case.

[00:18:22] Speaker 02:
On pages 13 to 17 of the Red Brief, you argue that under Moberly, a petitioner's theory of causation must be reputable and that reputable evokes Delbert.

[00:18:41] Speaker 02:
You then argue that because the

[00:18:43] Speaker 02:
Appellant's theory of causation fails under Daubert, can't be reputable.

[00:18:49] Speaker 02:
That's a fair summation, is it not?

[00:18:52] Speaker 04:
Your honor, Daubert is used as a way of analyzing the reputability.

[00:18:58] Speaker 04:
Are you arguing that under Moberly?

[00:18:59] Speaker 04:
It does not preclude the reputability.

[00:19:02] Speaker 02:
When I talk, you don't.

[00:19:02] Speaker 02:
That's why I said you should be sorry.

[00:19:06] Speaker 02:
Now, are you arguing that under Moberly, the special master is required to consider the Daubert factors?

[00:19:13] Speaker 04:
I'm arguing that he may.

[00:19:16] Speaker 04:
OK.

[00:19:20] Speaker 02:
That's fine.

[00:19:21] Speaker 02:
You've answered my question.

[00:19:23] Speaker 02:
On page 52 of the joint appendix, the Court of Federal Claims concluded that the special master's departure from the conclusions of four other special masters could only be explained by improper application of the standard of proof required in vaccine cases.

[00:19:38] Speaker 02:
And you make similar arguments on pages 18 to 23 of the red brief.

[00:19:43] Speaker 02:
What legal authority do you have holding that the decisions of those other special masters are binding in any way?

[00:19:50] Speaker 04:
They are not, Your Honor.

[00:19:51] Speaker 04:
They're persuasive.

[00:19:53] Speaker 02:
Does a failure to acknowledge or distinguish non-binding precedent render a decision arbitrary or capricious?

[00:20:00] Speaker 04:
By itself, Your Honor?

[00:20:01] Speaker 02:
No.

[00:20:02] Speaker 02:
Are you suggesting that these should be considered under Daubert?

[00:20:07] Speaker 02:
Yes, Your Honor.

[00:20:08] Speaker 02:
OK.

[00:20:08] Speaker 02:
Tell me why.

[00:20:09] Speaker 04:
Because Daubert looks at whether there is acceptance in the scientific community, and it does not have to be complete.

[00:20:18] Speaker 04:
It does not have to be general.

[00:20:20] Speaker 04:
And so the analysis in the other opinions talk about the acceptance to any, I'm sorry, Your Honor.

[00:20:28] Speaker 02:
No, no, no.

[00:20:29] Speaker 02:
Go on.

[00:20:30] Speaker 02:
Daubert deals with scientific method analysis.

[00:20:34] Speaker 02:
Am I not correct?

[00:20:35] Speaker 04:
Correct.

[00:20:36] Speaker 04:
Part of that is an analysis.

[00:20:38] Speaker 02:
But then how does a special master's decision fall within a doberra analysis?

[00:20:45] Speaker 02:
That's what I'm driving at.

[00:20:47] Speaker 02:
Now answer.

[00:20:48] Speaker 04:
Okay.

[00:20:48] Speaker 04:
The special master

[00:20:50] Speaker 04:
is allowed, they're not required, but they are allowed to look at the factors in Daubert to determine whether there is a peer-reviewed, I mean you know the factors better than anybody your honor.

[00:21:06] Speaker 02:
But that's not, I agree, if you're looking at scientific evidence that's fine, that's Daubert, but the special master is not a scientist or

[00:21:16] Speaker 02:
I suppose could be, but not what they're doing.

[00:21:18] Speaker 02:
It's not scientific analysis of the sort that falls within adobe analysis.

[00:21:23] Speaker 04:
No, but he's looking at how the expert is characterizing it.

[00:21:27] Speaker 04:
And so the expert is talking about the literature, and the special master is able to say,

[00:21:35] Speaker 04:
ask the expert and see the attorneys ask the expert, has this been accepted anywhere else?

[00:21:41] Speaker 04:
And in this case, their expert, Dr. Miller, conceded that this theory that vaccines cause SIDS has not been accepted anywhere.

[00:21:51] Speaker 04:
And in fact, he said that he doesn't make it outside the vaccine program.

[00:21:55] Speaker 04:
He's been rejected.

[00:21:56] Speaker 04:
I'm sorry.

[00:21:57] Speaker 02:
That's dope air.

[00:21:59] Speaker 02:
But what the special masters do is not dope air.

[00:22:04] Speaker 02:
Acceptance within the scientific community is a dober fact.

[00:22:09] Speaker 02:
But I don't see how you can get what the court below said that, well, you have these special mastery decisions, and failure to abide by them is a dober violation.

[00:22:27] Speaker 02:
It just doesn't work.

[00:22:29] Speaker 04:
I think he's saying they're arbitrary and capricious.

[00:22:31] Speaker 02:
Yeah, OK, or that they're arbitrary and capricious.

[00:22:34] Speaker 04:
which I do think is different, Your Honor.

[00:22:36] Speaker 02:
In her expert report and at the entitlement hearing, Dr. McClusker opined that upper respiratory tract infections are a purely mechanical risk factor for SIDS.

[00:22:51] Speaker 02:
And on page 40 of the blue brief, the appellants assert that HHS did not provide any medical literature to support that opinion.

[00:22:59] Speaker 02:
Is there any medical literature in the record to support Dr. McClusker's opinion?

[00:23:05] Speaker 04:
I don't believe so that that is a purely mechanical, you're on it.

[00:23:10] Speaker 02:
On page 31 of the red brief, you argue it was clear error in judgment for the special master to give Dr. Miller's testimony greater weight than Dr. McClusker's because other special masters had found her to be credible.

[00:23:26] Speaker 02:
Is it the government's position that once an expert is found credible, their conclusions must be accepted by the court regardless of the other evidence on the record?

[00:23:35] Speaker 04:
In other cases, no, Your Honor.

[00:23:37] Speaker 04:
That is part of our argument.

[00:23:40] Speaker 02:
On page 25 of the joint appendix, the special master notes that Dr. McClusker had made misleading statements on the findings of two medical articles.

[00:23:52] Speaker 02:
And on page 27 of the joint appendix, he notes that she made assertions about JB's sleeping position and crib contents

[00:24:01] Speaker 02:
that were not supported by or were contrary to the record and, in fact, were contrary to the interview that was conducted five days afterwards where there was a reenactment involving the police.

[00:24:16] Speaker 02:
How does that impact your credibility argument from Dr. McClusker?

[00:24:22] Speaker 04:
Well, Your Honor, I think that you look at this as a whole.

[00:24:26] Speaker 04:
You're taking the special master's statements

[00:24:31] Speaker 02:
I'm taking his analysis.

[00:24:34] Speaker 02:
He's a tri-finder effect and a concluder of law.

[00:24:42] Speaker 04:
You're taking his analysis and in addition to that analysis is the expertise that we have spelled out in our briefs.

[00:24:53] Speaker 04:
This case is effectively how cytokines work.

[00:24:57] Speaker 04:
and we have detailed extensively which of these experts is the expert on cytokines.

[00:25:04] Speaker 04:
And it is Dr. McCusker.

[00:25:06] Speaker 03:
It is not Dr. Miller.

[00:25:07] Speaker 03:
Yes, Your Honor.

[00:25:08] Speaker 03:
I am interrupting, but I just wanted to follow up.

[00:25:10] Speaker 03:
And this was the question right before the last that Judge Wallach was asking about.

[00:25:15] Speaker 03:
You conceded that the respondent's expert, so it's the differentiation between the impact of the cytokines, whether or not it's a mechanical thing or whether it's a neurochemical thing.

[00:25:28] Speaker 03:
The other side tells me that Dr. Miller had plenty of scientific support for his theory.

[00:25:36] Speaker 03:
And you acknowledged a moment ago to Judge Wallach that your expert had no support for her theory.

[00:25:44] Speaker 04:
No, Your Honor.

[00:25:45] Speaker 04:
What the literature in the case record shows is that the

[00:25:56] Speaker 04:
Appellants do not have any support for the theory that cytokines act in the way that they say they act.

[00:26:03] Speaker 04:
They do not cross the blood-brain barrier.

[00:26:07] Speaker 04:
All of the literature here talks about the expression of cytokines, their presence.

[00:26:14] Speaker 04:
None of it talks about their effect.

[00:26:17] Speaker 04:
There's a big difference on that.

[00:26:18] Speaker 04:
Now, what happens here is in, and if I may say in passing so we don't forget it, Your Honor,

[00:26:25] Speaker 04:
McCusker did not concede there was a brainstem defect here.

[00:26:29] Speaker 04:
She was asked hypothetically, if Dr. Kinney's triple risk theory applied, what would it look like?

[00:26:38] Speaker 04:
She absolutely did not.

[00:26:40] Speaker 04:
The special master got that wrong.

[00:26:43] Speaker 04:
That's incredibly important.

[00:26:45] Speaker 04:
because the case law, Knudsen and Hanlon in this court, make clear that you cannot prove a central fact by statistical analysis.

[00:26:59] Speaker 04:
Absolutely forget it.

[00:27:01] Speaker 03:
I hate to divert from our discussion of cycle.

[00:27:03] Speaker 03:
Let me just ask you about that.

[00:27:04] Speaker 03:
Was that discussed in the Court of Federal Claims?

[00:27:07] Speaker 03:
When you appealed the special master of the Court of Federal Claims, did you point out, is this something that if I go back and look in the record, you disputed it over time?

[00:27:16] Speaker 04:
Yes, Your Honor.

[00:27:17] Speaker 03:
OK.

[00:27:18] Speaker 04:
Go back to this.

[00:27:19] Speaker 04:
And I don't know.

[00:27:21] Speaker 04:
Anyway, I ascribe no ill.

[00:27:23] Speaker 04:
ill purpose to my brother on the other side.

[00:27:26] Speaker 04:
But it is just factually incorrect that Dr. McCuster can see that.

[00:27:31] Speaker 03:
OK, but leaving that aside, you've got to go back to the cytokines.

[00:27:33] Speaker 04:
Yes, please.

[00:27:33] Speaker 04:
And so the cytokines, basically, how they work is in a child that has the brainstem defect, the 5-HT, it basically is the door is closed.

[00:27:45] Speaker 04:
Imagine it as a door.

[00:27:47] Speaker 04:
And so the cytokines in the brainstem are knocking on the door.

[00:27:51] Speaker 04:
And they can't open it.

[00:27:53] Speaker 04:
And so the cytokines, the way it works is that there may be more cytokines in that area, but they don't actually have any effect on the child who has the 5-HT defect.

[00:28:11] Speaker 04:
The cytokines are basically there

[00:28:14] Speaker 04:
as the body's effort to solve this problem, which they cannot.

[00:28:19] Speaker 04:
It is not an additional causation that combines with the 5-HT and then kills this child.

[00:28:27] Speaker 04:
I mean, this case is of monumental significance.

[00:28:33] Speaker 04:
And I don't know what your docket is, but it's certainly the most important case that

[00:28:37] Speaker 04:
I have 1,000 cases in the torts branch, and this is the most important case.

[00:28:43] Speaker 04:
This is, do vaccines cause SIDS?

[00:28:46] Speaker 04:
Full stop.

[00:28:48] Speaker 04:
Full stop.

[00:28:49] Speaker 04:
And the science is clear, they do not.

[00:28:53] Speaker 04:
They do not.

[00:28:54] Speaker 04:
And thankfully, the Court of Federal Claims and hopefully the Federal Circuit will reach the right decision before there is a national and worldwide panic.

[00:29:06] Speaker 04:
for young parents on this.

[00:29:07] Speaker 03:
Well, you've got to give us a reason.

[00:29:08] Speaker 03:
So can you tell us why your friend answered one question I had about the cytokines, saying that there was a lot of medical evidence on Dr. Miller's side as to how he said the reaction is.

[00:29:23] Speaker 03:
A mild infection is, their theory is, a mild infection is linked acids because of the neurochemical response to cytokines.

[00:29:32] Speaker 03:
rather than purely the mechanical reasons, which was what your expert said.

[00:29:37] Speaker 03:
So tell me about that.

[00:29:38] Speaker 03:
What is the medical literature that they write on?

[00:29:41] Speaker 04:
Your Honor, I can go through.

[00:29:42] Speaker 04:
The answer is, as Dr. Miller conceded, there is no literature supporting his theory.

[00:29:50] Speaker 04:
He said in the hearing,

[00:29:51] Speaker 04:
I've connected the dots in a way that nobody else has, and nobody's done it outside the vaccine program.

[00:29:59] Speaker 04:
And so I can take you through every single one of his literature references and say why it doesn't apply.

[00:30:06] Speaker 04:
SIDS is an analysis of exclusion.

[00:30:11] Speaker 04:
We are looking at all of his literature, none of it supports

[00:30:16] Speaker 04:
that cytokines act in the way he says they act to cause SIDS and cause children to die.

[00:30:24] Speaker 04:
And now I'm happy to walk through each one of the literature and each case study to get there.

[00:30:31] Speaker 04:
And so that's it.

[00:30:33] Speaker 04:
I mean, if you take what the special master did here, and do not mistake length for rigor, is what he did is he allowed Dr. Miller to take a snippet from here, a snippet from there, and then come up with what he called a plausible mechanism.

[00:30:49] Speaker 04:
He called reasonable.

[00:30:51] Speaker 04:
There is no federal circuit opinion where reasonable is the standard.

[00:30:55] Speaker 04:
And in fact, in Moberly,

[00:30:57] Speaker 04:
This court rejected plausibility as the standard.

[00:31:01] Speaker 04:
It's simply not reputable.

[00:31:03] Speaker 04:
It's not sound science.

[00:31:05] Speaker 04:
This expert came up with a connecting dots theory that nobody else in the world has done.

[00:31:14] Speaker 04:
It's not peer reviewed.

[00:31:16] Speaker 04:
It is, there is this junk science of the first order that is incredibly dangerous.

[00:31:22] Speaker 01:
But isn't it even worse junk science to say, because nobody knows why this infant, nobody knew in advance that this infant was going to have an adverse reaction.

[00:31:35] Speaker 01:
Therefore the vaccine act provides no protection.

[00:31:40] Speaker 01:
Where is the sound science in that conclusion?

[00:31:44] Speaker 04:
Your presumption is faulty, Your Honor, I say respectfully, because the vaccine is... There is no proof that the vaccine caused this child to die of SIDS.

[00:31:55] Speaker 01:
We have... There's nothing that says that it didn't at least trigger the reaction.

[00:32:02] Speaker 01:
The response was just about instantaneous.

[00:32:05] Speaker 01:
It's very hard to say, and I don't think anyone did, that everything was just pure chance.

[00:32:12] Speaker 04:
Your Honor, the burden of proof is on the other side, because this is a non-table injury.

[00:32:18] Speaker 01:
Are you sure?

[00:32:19] Speaker 01:
I am absolutely sure, Your Honor.

[00:32:21] Speaker 01:
The burden is on the other side.

[00:32:22] Speaker 01:
This is really what I was trying to explore in the beginning.

[00:32:25] Speaker 01:
When there is an instant adverse reaction, in this case, death, nonetheless, there is no presumption, no prima facie anything, no movement of the burdens

[00:32:42] Speaker 04:
Correct.

[00:32:44] Speaker 04:
Correct.

[00:32:45] Speaker 01:
The only... Yes, we have some cases which say that you must prove.

[00:32:50] Speaker 01:
If you were able to prove that there was a relationship in advance, you'd test the infant.

[00:32:56] Speaker 01:
And if the infant has the propensity that it will instantly die

[00:33:01] Speaker 01:
and be called SIDS.

[00:33:03] Speaker 01:
SIDS means you don't know why the infant died.

[00:33:06] Speaker 01:
So you would at least attempt to discover in advance that this is the situation you're going to encounter.

[00:33:15] Speaker 04:
Your Honor, you can't.

[00:33:16] Speaker 04:
You'd have to cut the child open.

[00:33:18] Speaker 04:
You cannot determine in advance a brainstem defect without autopsying the child.

[00:33:26] Speaker 01:
Exactly.

[00:33:27] Speaker 01:
That's what this whole statute, as I understood it, was about.

[00:33:32] Speaker 04:
No, Your Honor.

[00:33:32] Speaker 01:
It can't tell in advance.

[00:33:34] Speaker 01:
Therefore, you need at least enough of a safeguard that you don't adversely infect the national policy of vaccines, which I think everyone agrees are very important.

[00:33:47] Speaker 04:
No, Your Honor.

[00:33:48] Speaker 04:
There are table injuries and non-table injuries.

[00:33:52] Speaker 04:
When it's a table injury, the government has the burden of proof to prove by

[00:33:58] Speaker 04:
reputable sound and reliable medical or scientific evidence that the vaccine did not cause the injury.

[00:34:07] Speaker 01:
When it's a non-table injury, petitioners have the exact... I think even now, since no one knows what the cause, we still have unfortunately enough unknown sudden death of the infant.

[00:34:21] Speaker 01:
And when that follows,

[00:34:25] Speaker 01:
within hours or less, the administration of the vaccine, is it still unknown?

[00:34:32] Speaker 04:
Yes, Your Honor.

[00:34:33] Speaker 04:
There is no scientific evidence to prove that vaccines cause SIDS.

[00:34:40] Speaker 01:
None.

[00:34:41] Speaker 01:
That's the problem.

[00:34:42] Speaker 01:
That's why the statute was enacted, because you couldn't prove it either way.

[00:34:47] Speaker 04:
I'm not saying either way.

[00:34:48] Speaker 04:
There is no scientific evidence that vaccines cause SIDS.

[00:34:53] Speaker 04:
I want to be

[00:34:55] Speaker 04:
Absolutely clear on that for both this court and for the population at large.

[00:35:00] Speaker 04:
There is no scientific evidence that vaccines cause SIDS.

[00:35:06] Speaker 04:
The petitioners have the burden to prove otherwise by reputable, sound, and reliable scientific or medical evidence.

[00:35:17] Speaker 04:
They have not.

[00:35:18] Speaker 04:
Each one of the articles they put forth, each of the case studies, which are the lowest form

[00:35:24] Speaker 04:
of scientific evidence are all easily distinguishable in that cytokines do not act the way Dr. Miller says they act.

[00:35:34] Speaker 01:
Cytokines aren't in the statute.

[00:35:36] Speaker 04:
Say that again please, Your Honor.

[00:35:38] Speaker 01:
Cytokines aren't mentioned in the statute.

[00:35:42] Speaker 01:
As the science is evolving, why there is this adverse reaction is starting to be understood.

[00:35:50] Speaker 01:
I agree with that.

[00:35:54] Speaker 01:
Okay, I didn't want to take us down that path.

[00:35:58] Speaker 03:
All right, any final word?

[00:36:00] Speaker 03:
You've exhausted your time.

[00:36:02] Speaker 04:
I could keep going if you'd like.

[00:36:04] Speaker 04:
That's okay.

[00:36:05] Speaker 04:
Thank you, Your Honor.

[00:36:11] Speaker 03:
You've got a little rebuttal time.

[00:36:12] Speaker 00:
Thank you.

[00:36:14] Speaker 00:
I just have a couple points I want to address.

[00:36:17] Speaker 03:
Can I just add, and I won't take this out of your tongue, but just one quick clarification, because I do think it's a very key point.

[00:36:24] Speaker 03:
Your friend tells us that there was no concession by the other side on this brain abnormality thing, and that they pressed that at the Court of Mines or whatever.

[00:36:34] Speaker 03:
You have a disagreement with anything he said about that?

[00:36:38] Speaker 00:
Personally, I do believe it was a concession, and the special master believed it was a concession as well.

[00:36:43] Speaker 00:
And I think the question isn't whether we believe

[00:36:46] Speaker 00:
it was a concession, but whether it was rational for the special master to find that it was concession based on her testimony.

[00:36:53] Speaker 03:
OK.

[00:36:54] Speaker 03:
I'm sorry to take your time.

[00:36:55] Speaker 00:
Go ahead.

[00:36:57] Speaker 00:
So I just wanted to address a couple of things.

[00:36:59] Speaker 00:
The respondent mentioned that the vaccine program is not designed to give money when there is no scientific proof of injury.

[00:37:05] Speaker 00:
But that's not the standard in the Vaccine Act standard.

[00:37:09] Speaker 00:
Scientific certainty is not the standard.

[00:37:11] Speaker 00:
It's preponderance of the evidence.

[00:37:13] Speaker 00:
He also responded, mentioned that there was no literature that cytokines cross the blood-brain barrier, and that there's no literature, and all the literature deals with cytokine expression, and neither of those things is true.

[00:37:26] Speaker 02:
That's what I wanted an answer on.

[00:37:29] Speaker 00:
Yeah, it's almost ubiquitous in the literature that cytokines, from a peripheral insult, including infection, vaccination, can and do cross the blood-brain barrier.

[00:37:39] Speaker 00:
And in fact, there's direct evidence.

[00:37:41] Speaker 02:
Cytos is something.

[00:37:42] Speaker 00:
There is direct evidence in this case that that did happen.

[00:37:46] Speaker 00:
There is a great deal of literature in this case that deals with cytokine expression, but there's also a great deal of literature that deals with the function of those cytokines when they are in the central nervous system and interact with neurons in the brainstem.

[00:38:00] Speaker 00:
And that literature is in the form of animal studies and in vitro studies.

[00:38:04] Speaker 00:
The Stoltenberg Frone and Rambilla show that cytokines such as IL-1, when they interact with 5-HT neurons in the brainstem, they can cause a prolonged apneas and interfere with a lot of resuscitation.

[00:38:19] Speaker 00:
So there is the literature that deals with the expression of cytokines in these areas of the brain, and also that deals with the function of these cytokines.

[00:38:25] Speaker 02:
There's a record site on those, please.

[00:38:44] Speaker 00:
So the Frone article is at appendix 736 through 740.

[00:38:48] Speaker 00:
Try to find Brambilla.

[00:39:00] Speaker 04:
Do you want it?

[00:39:01] Speaker 04:
I have it.

[00:39:02] Speaker 00:
If you have it, sure.

[00:39:04] Speaker 00:
Brambilla is appendix 600 to 607.

[00:39:09] Speaker 00:
Thank you.

[00:39:09] Speaker 00:
And then Stoltenberg.

[00:39:11] Speaker 00:
I'm not sure Stoltenberg.

[00:39:15] Speaker 00:
Part of the appendix.

[00:39:19] Speaker 00:
But there is an additional article, Stoltenberg as well.

[00:39:21] Speaker 00:
It's similar to the Frone article.

[00:39:25] Speaker 00:
And they deal with cytokine function.

[00:39:27] Speaker 00:
Thank you.

[00:39:32] Speaker 00:
So I also just wanted to point out, in this case, JB also had a post-vaccinal fever, which is its own exogenous risk factor.

[00:39:39] Speaker 03:
And it's also a good example of how mild... I thought your position was that the fever, or Dr. Miller's position was that the fever was not dispositive or even relevant.

[00:39:48] Speaker 00:
I think the fever, there are two reasons the fever is important.

[00:39:52] Speaker 00:
First is its own separate exogenous risk factor.

[00:39:54] Speaker 00:
And also it provides direct evidence that the vaccine secondary to the vaccination did cross the blood brain barrier and interacted with neurons in JB's brain.

[00:40:03] Speaker 00:
Both points that Dr McCusker agreed with as well.

[00:40:08] Speaker 00:
So post-vaccinal fever is also mentioned in literature as an exogenous risk factor, and it's a good example of how mild infection or an inflammatory insult can operate as a neurochemical risk factor, as elevated temperature has been shown to prolong apnea and interfere with auto-resuscitation.

[00:40:25] Speaker 00:
And even mild infection can increase CO2 levels in infants under three months of age.

[00:40:29] Speaker 00:
Those increases in co2 levels is shown in literature and so animal studies to be the result of the cytokines secondary to the the infection