[00:00:02] Speaker 04:
The first case for argument this morning is 16-1-6-0-9, AK versus Secretary of Health and Human Services.

[00:00:10] Speaker 04:
Mr. Gaynor, whenever you're ready.

[00:00:17] Speaker 02:
Good morning, Your Honors, and may it please the Court.

[00:00:20] Speaker 02:
This case presents at its core the same question that was addressed in Millett versus Secretary of Health and Human Services.

[00:00:27] Speaker 02:
This is the 20th of this year.

[00:00:29] Speaker 02:
as to which a certiorari petition is now pending.

[00:00:33] Speaker 04:
The issues are- So you recognize that we don't have the authority to overturn another panel decision at this level, correct?

[00:00:41] Speaker 02:
Yes, Your Honor.

[00:00:41] Speaker 02:
Under Circuit Rule 35A, a party may argue in its brief and moral argument over rule, the president and the panel will decide whether to ask for rehearing and banque.

[00:00:52] Speaker 02:
And that is why I'm here today, because I believe that- and the petitioners believe that Millic should be overruled.

[00:00:59] Speaker 02:
And the procedural avenue for this is for petitioners to come before this court, this panel, and ask that the matter be referred to the en banc panel.

[00:01:07] Speaker 00:
So you want us to recommend to the full court that this case be heard en banc?

[00:01:12] Speaker 02:
Yes, Your Honor.

[00:01:14] Speaker 00:
And we believe there are substantial, very substantial reasons that that shouldn't.

[00:01:19] Speaker 00:
But in that regard, doesn't it make sense if a cert petition is pending to see what happens in that regard?

[00:01:27] Speaker 02:
Well, Your Honor, at least

[00:01:29] Speaker 02:
In a sense, a cert petition is always a speculative matter.

[00:01:33] Speaker 02:
And as the court is well aware, if the Supreme Court denies cert, as it does in the vast majority of cases of any sort whatsoever, that itself does not send a precedential signal one way or the other.

[00:01:43] Speaker 02:
That's certainly an option that's available and open to this court.

[00:01:46] Speaker 02:
But obviously, if the court wants to take that view of the case, then perhaps it should hold this case in abeyance.

[00:01:57] Speaker 04:
But you are arguing the alternative.

[00:01:58] Speaker 04:
Why don't you make the assumption that we are bound by the precedent, and so unless and until there's a rehearing petition or a cert petition granted, we're going to apply current law.

[00:02:08] Speaker 02:
Yes, or under Rule 35A, and which is why I'm here today, I would recommend to the unbound panel that Millic and this issue be, that the issue resolved in Millic be reconsidered in this case, and that Millic be overruled.

[00:02:25] Speaker 02:
Millic is, Your Honor.

[00:02:26] Speaker 02:
First, I'd like to talk briefly about stare decisis and why I believe and why I think the cases strongly suggest that stare decisis is not an important consideration, which should influence this court strongly to not grant rehearing in this case.

[00:02:42] Speaker 02:
Stare decisis is an important consideration, but it's a principle of judicial policy, as the Supreme Court has emphasized, and not an inexorable command.

[00:02:51] Speaker 02:
And the court has also made clear, when I say the court, I mean the Supreme Court has made clear

[00:02:55] Speaker 02:
than it is at its zenith in cases concerning statutory interpretation, and at its nadir, at its weakest in cases concerning constitutional interpretation.

[00:03:05] Speaker 02:
And I didn't brief this issue because when I was doing the briefing, no, it was not final.

[00:03:11] Speaker 02:
The cases to that effect are Manila v. Department of Social Services, 436 U.S.

[00:03:15] Speaker 02:
658 and 695, and more recently, Fife v. Jubilier,

[00:03:21] Speaker 02:
541 US 267 at 305.

[00:03:23] Speaker 01:
Are you familiar with footnote three in Millick?

[00:03:27] Speaker 01:
That's the one where the court says that Stern was narrowed in the wellness case.

[00:03:34] Speaker 01:
Stern?

[00:03:34] Speaker 01:
Do you have a response to that?

[00:03:35] Speaker 02:
Well, Your Honor, the court seems to say that Stern was narrowed in the wellness case because wellness said, well, if there's consent of the parties, then the Article III implications don't come in this way.

[00:03:46] Speaker 02:
And that's certainly true if the parties consent to it, and that was clear in Stern.

[00:03:50] Speaker 02:
In the situation in the Stearner honor, the bankruptcy creditor had no choice but to follow and bring the case in bankruptcy court.

[00:03:59] Speaker 02:
So the Stearn court held that he couldn't properly consent, that that wasn't a valid consent for Article III purposes, and he hadn't waived whatever Article III rights he could otherwise assert.

[00:04:10] Speaker 02:
The same situation is true here for reasons that have to do with the Milch's court's misapplication and misunderstanding of Brissowitz and of the structure of the Vaccine Act and its predictive effect.

[00:04:20] Speaker 02:
Essentially, my clients, the petitioners, and other people in their situation have no alternative.

[00:04:26] Speaker 02:
Therefore, just like the bankruptcy creditor in Stern, they can't effectively consent because, and this is the language from Stern, they have nowhere else to go.

[00:04:37] Speaker 02:
That's totally the language from Stern, and the Stern court insists.

[00:04:41] Speaker 02:
Equivocally, that means they didn't consent.

[00:04:43] Speaker 02:
The same situation obtains in this case because

[00:04:47] Speaker 02:
There is no for petitioners whose claims are of the nature of these claims, which are of the nature design defect claims.

[00:04:55] Speaker 02:
They have nowhere else to go.

[00:04:57] Speaker 02:
The Millet Court was simply wrong.

[00:04:59] Speaker 02:
Simply, and I say this all respectfully, but the Millet Court was wrong, Your Honors, to say that the Millets could revisit that issue in Article III court or presumably in a correlative state court.

[00:05:12] Speaker 02:
And the reasons can be seen when you look at the structure of the Vaccine Act.

[00:05:16] Speaker 02:
the quid pro quo, the structural quid pro quo that Congress was working there and what they intended to achieve in the Vaccine Act.

[00:05:23] Speaker 02:
And then when you look at Broussowitz and Broussowitz straightforward interpretation of what Congress intended to achieve, stepping back and looking at the picture, what you see is that the Vaccine Act and the compensation scheme under the Vaccine Act is essentially a structural quid pro quo, as the Broussowitz Court says, to the vaccine manufacturers.

[00:05:42] Speaker 02:
Congress has said to the vaccine manufacturers, we want to protect you from being sued and having outrageous verdicts that could, huge verdicts, I shouldn't say outrageous, but very large verdicts that could drive you out of the vaccine market.

[00:05:56] Speaker 02:
So we will set up this structural quid pro quo.

[00:05:58] Speaker 02:
You will be immune to a large extent from liability.

[00:06:03] Speaker 02:
You'll be immune.

[00:06:03] Speaker 02:
You can't be sued.

[00:06:05] Speaker 02:
And then, in return, the government will take a little chip of money from every vaccine that's given to anyone in the United States and put that little chip, that penny or fraction of a penny, into the pot of the Vaccine Injury Trust Fund.

[00:06:18] Speaker 02:
And then when petitioners claim, as they will, in some small fraction of cases, because they're unavoidably dangerous vaccines, but only to a very, very small number of people, which is why Congress has wisely said we need this act to encourage vaccines in the vast majority of circumstances,

[00:06:35] Speaker 02:
When somebody comes in with a claim, they sue not the vaccine manufacturer, but the party that's been substituted for the vaccine manufacturer by Congress.

[00:06:44] Speaker 02:
And that party is the Secretary of Health and Human Services.

[00:06:47] Speaker 02:
So in that sense, they don't have a choice.

[00:06:50] Speaker 02:
They're not given the option of going into federal court under the Divorce Law jurisdiction or into state court and saying, my child or I was injured by an unavoidable consequence of these vaccines.

[00:07:03] Speaker 02:
not by manufacturing defect, because we can't allege one.

[00:07:07] Speaker 02:
In most cases, there aren't.

[00:07:09] Speaker 02:
The manufacturing process is extremely, strictly regulated down to the temperature of the facilities in which the vaccines are manufactured.

[00:07:17] Speaker 02:
And therefore, manufacturing defect claims, which are not preempted, are a very, very small fraction of the universe of potential claims.

[00:07:25] Speaker 02:
Failure to warn claims, which are the other of the, what Bruce would call the classic triumvirate of product liability claims,

[00:07:33] Speaker 02:
Failure to warrant claims are expressly precluded under the Vaccine Act.

[00:07:38] Speaker 02:
If the warnings are given in accordance with federal regulations, there's no lawsuit.

[00:07:44] Speaker 02:
That's that.

[00:07:44] Speaker 02:
So that leaves only the design defect or cases in the nature of design defect cases.

[00:07:51] Speaker 02:
And so what you have is that that's the compensation.

[00:07:54] Speaker 02:
Excuse me, that's the structural quid pro quo that the Supreme Court found was so important.

[00:07:59] Speaker 02:
Now, what Millic said, and Millic was, and I respectfully

[00:08:03] Speaker 02:
submit, profoundly mistaken at this point.

[00:08:06] Speaker 02:
And that's why it should be one of the two reasons it should be overruled.

[00:08:09] Speaker 02:
And what it said was, well, the millets can just go in and file a manufacturing defect claim.

[00:08:14] Speaker 02:
Well, of course, they can't, because they can't allege a manufacturing defect claim.

[00:08:18] Speaker 02:
There's no reason to believe one.

[00:08:19] Speaker 02:
This, like most of these cases, involves the unavoidable side effects of the vaccine.

[00:08:24] Speaker 02:
Well, then the medical court said you could just allege that as breach of implied warranty or breach of contract.

[00:08:30] Speaker 02:
Well, as to breach of contract, there's

[00:08:32] Speaker 02:
privity problem in most states.

[00:08:34] Speaker 02:
But even aside from that, if you look at the product liability cases, and I've cited a few in the literature, what they say is that for product liability purposes, breach of implied warranty is essentially another way to plead strict design defect product liability.

[00:08:50] Speaker 02:
It's essentially coextensive.

[00:08:53] Speaker 02:
And I've cited the cases that say that from various circuits, from a couple of circuits.

[00:08:58] Speaker 02:
And the law is generally pretty clear on this, that if you can't allege

[00:09:02] Speaker 02:
a design defect, you're not going to be allowed to plead around that by alleging a breach of implied warranty that is essentially saying you breached your implied warranty because you sold me an unavoidably defective bond.

[00:09:15] Speaker 02:
It's essentially the same pleading.

[00:09:17] Speaker 02:
But if you were allowed to do that, as the millet court suggests, these people can just go in and file in federal court or state court, then essentially what you've done, look back at the structural quid pro quo, you have

[00:09:31] Speaker 02:
vanquished, you have struck down the manufacturer's shield that they got, the structural pre-quo pro, the protection that they got from being sued in civil court.

[00:09:41] Speaker 00:
Mr. Gaynor, can I ask you a question?

[00:09:42] Speaker 00:
Yes.

[00:09:44] Speaker 00:
You argue to change gears a little bit, perhaps.

[00:09:49] Speaker 00:
You argue, I believe, that under whatever standard of review is applied, that you should prevail, correct?

[00:09:57] Speaker 00:
That is correct, Your Honor.

[00:09:58] Speaker 00:
And I just wanted to ask you a little bit about that.

[00:10:01] Speaker 00:
went over the decision of the Court of Federal Claims and the underlying decision of the special master.

[00:10:10] Speaker 00:
And the special master's decision, which is basically what we're reviewing, as I understand it, is exhaustive.

[00:10:18] Speaker 00:
I mean, it looks at every point, decides, says, here's why I credit this witness, here's why I don't credit this witness, examines everything from six different angles, it seems.

[00:10:30] Speaker 00:
I, it struck me as difficult to say how whether under an arbitrary or capricious standard, which is what you're saying is wrong, or a more exacting standard of view, we could overturn that.

[00:10:42] Speaker 00:
Could you speak to that?

[00:10:43] Speaker 02:
Well, yes, Your Honor.

[00:10:44] Speaker 02:
I'd be glad to.

[00:10:45] Speaker 02:
And here we have the special master.

[00:10:49] Speaker 02:
And she goes through, and with all due respect to the special master, she goes through every piece of evidence, and she resolves every possible inference in favor of the government.

[00:10:58] Speaker 02:
Where there's anything to resolve is the finder of fact.

[00:11:00] Speaker 02:
takes it in favor of the government, and every possible inference against the petitioners and their experts.

[00:11:06] Speaker 02:
And when she does that, first of all, that itself shouldn't, well, that has article one implications itself, because if that's reviewed on arbitrary.

[00:11:15] Speaker 00:
You're saying that in itself is kind of a red flag?

[00:11:17] Speaker 02:
I think it is, Your Honor, with all due respect.

[00:11:20] Speaker 02:
And then secondly, getting down to the specifics.

[00:11:23] Speaker 02:
So the special master says, and this is complicated, and I don't want to spend all of my time on this, but I think that just to give you a sense of why this shouldn't

[00:11:30] Speaker 02:
meet the arbitrary and capricious standard.

[00:11:32] Speaker 02:
We've tried to lay that out in our briefs, hopefully successfully.

[00:11:35] Speaker 02:
But one of it is she rejects, she says, this child does not have a mitochondrial disorder.

[00:11:41] Speaker 02:
Doesn't have one, period.

[00:11:42] Speaker 02:
That's her finding effect.

[00:11:44] Speaker 02:
Now to do that, she has to reject not just Dr. John Schaffner, who is one of the preeminent physicians in the United States on mitochondrial disorders, and is also a treating physician in this case,

[00:11:55] Speaker 02:
But she has to ignore essentially what the government-owned expert Dr. Cohen says.

[00:12:00] Speaker 02:
Dr. Cohen says that the published diagnostic paradigms, the Bernier criteria, for example, and I quote, are not meant to account for all clinical outcomes and not designed to address incongruent data.

[00:12:13] Speaker 02:
And ultimately, it is up to the clinician to determine whether a mitochondrial disorder is present.

[00:12:18] Speaker 02:
That's what the government's own expert says.

[00:12:22] Speaker 02:
ignore that, essentially, to come to her own conclusion.

[00:12:26] Speaker 02:
So that is, on that standard, arbitrary and capricious.

[00:12:29] Speaker 02:
And as to the question of the closely related question of the normalization of the Bernier criteria, she says, well, it's not the gold standard, because Dr. Cohen said there is no gold standard, but she says it's still pretty useful.

[00:12:42] Speaker 02:
But Dr. Cohen says

[00:12:43] Speaker 02:
In fact, I use it, but my colleague at the Cleveland Clinic, Dr. Hoppel, doesn't.

[00:12:48] Speaker 02:
We find about this all the time.

[00:12:50] Speaker 02:
Ultimately, it's a matter of clinical judgment.

[00:12:53] Speaker 02:
And the normalization is, and his words, a bit arbitrary anyway.

[00:12:59] Speaker 02:
So how confident can a reasonable trier of fact be in that kind of evidence when the government's own expert won't come in and deal with it?

[00:13:08] Speaker 02:
And then there are other big problems with the findings of fact here.

[00:13:11] Speaker 02:
As to the speech delay.

[00:13:13] Speaker 02:
of this child, which certainly predated the flu vaccine.

[00:13:17] Speaker 00:
You're talking now about the conclusion that autism manifested itself in various ways through the video, et cetera, before these two vaccinations.

[00:13:28] Speaker 02:
Yes, exactly, Your Honor.

[00:13:30] Speaker 02:
I should have made that transition more explicit.

[00:13:33] Speaker 02:
I jumped right to it.

[00:13:34] Speaker 02:
But you're exactly correct.

[00:13:36] Speaker 02:
As to that, the speech delay

[00:13:38] Speaker 02:
The government's own expert, Dr. Miller, says it's not even anymore a diagnostic criteria of autism of ASD.

[00:13:47] Speaker 02:
It's not used anymore.

[00:13:48] Speaker 02:
But the special master seems to think it's still useful, even though it's been abandoned as a diagnostic criteria.

[00:13:53] Speaker 02:
Well, somehow it still is.

[00:13:55] Speaker 02:
That seems to be the government's position.

[00:13:57] Speaker 02:
Then we have the question of, well, we have all these treating physicians who saw this child, who saw the videotapes and pediatricians, who looked.

[00:14:08] Speaker 02:
They didn't see any signs of ASD in this child prior to the vaccines.

[00:14:13] Speaker 02:
The government hires the expert, a psychologist, not a physician, to go back and look at the videotapes from years ago.

[00:14:19] Speaker 02:
And she says, well, these videotapes show signs of ASD, which no one at the time would have been expected to see because they weren't developed at that time.

[00:14:30] Speaker 02:
But now we can see them.

[00:14:32] Speaker 02:
And then on examination, she says, well,

[00:14:36] Speaker 02:
Why didn't they see them?

[00:14:37] Speaker 02:
Well, and this is her language, because the signs of behavior in the child, supposedly giving rise to now a clinician's view of what might be ASD, were, and I quote once again, too close to normal, unquote.

[00:14:52] Speaker 02:
In other words, they're extraordinarily weak because they're the signs that any normal child would have.

[00:14:58] Speaker 02:
And now they've gone back and reinterpreted that to mean autism spectrum disorder.

[00:15:06] Speaker 02:
ignoring all the pediatricians at the time and every other doctor who testified in this and crediting this clinical psychologist who was not a treating physician.

[00:15:16] Speaker 02:
So under these standards, I think it can't survive the arbitrary and capricious, but even if it could, Your Honor, I think this case is extraordinarily weak.

[00:15:24] Speaker 02:
Now when we look at the standards of review, the arbitrary and capricious standard is the most maximally deferential standard known to Federals.

[00:15:33] Speaker 01:
Wasn't the expert that the government relied on who looked at the videotapes?

[00:15:36] Speaker 01:
I'm trying to find it right now, but if I recall she had the job of diagnosing Autism and had done so for many many patients.

[00:15:46] Speaker 01:
Am I am I correct?

[00:15:48] Speaker 02:
She is a was at the Philadelphia Children's Hospital if I recall correctly, and yes, she is a psychologist who specializes in autism And so is your position that the special master erred in relying on what her testimony?

[00:16:03] Speaker 02:
Well, Your Honor, when the special master relied on that testimony, she chose to disregard a lot of other testimony.

[00:16:10] Speaker 02:
And you can rely on that testimony, but if the standard of arbitrary and capricious allows picking out little bits of evidence, essentially, and not looking at the way that the expert has essentially allowed herself to be impeached on the stand by science that she says

[00:16:28] Speaker 02:
are so close to normal that no reasonable doctor would be expected to look at them.

[00:16:33] Speaker 02:
And I, the expert with the benefit of many years hindsight, can now see under diagnostic criteria that didn't apply at the time that, yes, that looks arbitrary and capricious.

[00:16:45] Speaker 02:
It's ignoring the vast majority, the great weight of the evidence, picking out little bits of evidence and hanging one's hat on it.

[00:16:53] Speaker 02:
You can go exhaustively through almost any complex record and find something that will support an aberrational view of the facts.

[00:17:02] Speaker 02:
And with all due respect, I think that's what's happened here.

[00:17:04] Speaker 04:
OK.

[00:17:05] Speaker 04:
You've exceeded your time.

[00:17:06] Speaker 04:
Why don't we hear from the government and we'll restore two minutes of rebuttal.

[00:17:09] Speaker 04:
Thank you.

[00:17:16] Speaker 04:
Ms.

[00:17:17] Speaker 03:
Perlman, good morning.

[00:17:18] Speaker 03:
Good morning.

[00:17:18] Speaker 03:
May it please the court?

[00:17:20] Speaker 03:
Perhaps not surprisingly, the government believes that the Millick panel properly decided the constitutional issue.

[00:17:25] Speaker 03:
For 25 years, the standard of review that was set forth in Hines and reaffirmed in Munn and reaffirmed pretty much by every panel that has considered findings of fact in front of this court has determined that the arbitrary and capricious standard is the correct standard of review.

[00:17:43] Speaker 03:
The petitioners, as you know, filed for rehearing a bonk in Millick, and that was denied.

[00:17:48] Speaker 03:
So they did exhaust their review in this court.

[00:17:53] Speaker 03:
There's a cert petition.

[00:17:54] Speaker 03:
Was it filed last Thursday?

[00:17:56] Speaker 03:
I believe it was.

[00:17:56] Speaker 03:
I have not seen it yet.

[00:18:00] Speaker 03:
But I gather from what was being said that it already was the same thing that was already in the on-bonk briefing.

[00:18:12] Speaker 03:
So obviously, we request that this court evaluate the case under the standard of review that has been in place for 25 years.

[00:18:20] Speaker 03:
In this causation, in fact, case, it was petitioner's burden to demonstrate with preponderant evidence their contention that two flu vaccines injured their child.

[00:18:30] Speaker 03:
And after, and you said it very well, Judge Schall, it was an exhaustive review that the special master undertook.

[00:18:37] Speaker 03:
She looked at hundreds of exhibits, 1,800 pages of testimony,

[00:18:42] Speaker 03:
that covered more than a dozen fact and medical witnesses and concluded that petitioners failed to meet their burden.

[00:18:48] Speaker 03:
The decision is 161 pages long, and she meticulously examined and weighed all of the evidence and provided a sound rationale for each of her conclusions that the critical factual predicates on which appellants' allegations were based were not supported by the evidentiary record.

[00:19:06] Speaker 03:
My colleague went through some, picked out some things that he believes were arbitrary and capricious.

[00:19:12] Speaker 03:
And I believe that the decision clearly sets forth why that is in fact not the case.

[00:19:19] Speaker 03:
Take for instance the diagnosis of mitochondrial disorder.

[00:19:23] Speaker 03:
There is no doubt that diagnosing mitochondrial disease involves an analysis of a number of signs and symptoms.

[00:19:30] Speaker 03:
You have to look at lab data.

[00:19:31] Speaker 03:
You have to look at clinical data.

[00:19:33] Speaker 03:
And the special master did.

[00:19:34] Speaker 03:
We had two preeminent mitochondrial specialists, Dr. Cohen, who is a clinician and a pediatric neurologist and mitochondrial specialist, and Dr. Wallace, who does mitochondrial biology.

[00:19:44] Speaker 03:
He just looks at the labs.

[00:19:47] Speaker 03:
Excuse me.

[00:19:49] Speaker 03:
And they said it does not meet the standard.

[00:19:52] Speaker 03:
It does not meet any standard.

[00:19:54] Speaker 03:
That is true.

[00:19:55] Speaker 03:
There's not one generally accepted criteria.

[00:19:57] Speaker 03:
But it does not meet any standard.

[00:19:59] Speaker 03:
Now part of the problem with Petitioner's case is that

[00:20:03] Speaker 03:
their expert, Dr. Kendall, said, I think he has mitochondrial disease because he meets this Bernier criteria.

[00:20:10] Speaker 03:
But when she was questioned on why he meets these different criteria, her opinion completely crumbled.

[00:20:17] Speaker 03:
She started backing off from that.

[00:20:20] Speaker 03:
I believe if you look through the evidence in the 22 pages that the special master spent going through the evidence, it is clear that

[00:20:30] Speaker 03:
petitioners failed to offer reliable persuasive evidence that the child has a mitochondrial disorder.

[00:20:36] Speaker 03:
And instead, she credited respondents experts.

[00:20:40] Speaker 03:
Another piece of evidence that my colleague pointed out is the testimony of Dr. Miller and the issue of whether or not the autism predated the vaccines.

[00:20:52] Speaker 03:
Dr. Miller is one of the preeminent specialists in diagnosing autism.

[00:20:58] Speaker 03:
It is the job of a clinical psychologist like Dr. Miller to diagnose autism.

[00:21:02] Speaker 03:
Dr. Shafrier admitted that.

[00:21:04] Speaker 03:
He said, we asked the psychologist what the diagnosis is.

[00:21:07] Speaker 03:
He just treats them.

[00:21:09] Speaker 03:
So the special master's reliance on Dr. Miller to go through the videotapes and identify.

[00:21:15] Speaker 03:
And there were 88 videotapes.

[00:21:17] Speaker 03:
These were hours and hours.

[00:21:19] Speaker 03:
And she took us through and showed us exactly where she believed these symptoms were manifesting.

[00:21:26] Speaker 03:
And the special master credited that.

[00:21:28] Speaker 03:
She had every right to credit it, in part because of Dr. Miller's credentials, in part because it was what she was seeing with her own two eyes, and in part because Dr. Cohen, a pediatric neurologist who does deal with children with developmental delays and autism, corroborated everything that Dr. Miller said.

[00:21:47] Speaker 03:
So it was certainly not arbitrary, capricious.

[00:21:50] Speaker 03:
And under any standard of review, we believe that the special master's findings were correct.

[00:22:01] Speaker 03:
The one other factual issue that did not come up that the special master decided was that there was no regression in temporal proximity to either vaccine that was given.

[00:22:13] Speaker 03:
And we believe that the record clearly supports the special master's determination.

[00:22:19] Speaker 03:
There was nothing in the contemporaneous medical records describing the developmental regression that petitioners were claiming existed.

[00:22:26] Speaker 03:
There's nothing in the videos.

[00:22:28] Speaker 03:
There's nothing in the early medical histories.

[00:22:30] Speaker 03:
For months and months and months, there's no mention of this supposed complete deterioration in this child's development.

[00:22:43] Speaker 03:
This finding was important because both Dr. Kendall and Dr. Shafir's causation opinions relied heavily on the supposition that onset of the ASD was temporarily related to the administration of the flu vaccines, but it wasn't.

[00:22:56] Speaker 03:
It predated the vaccines, and it did not get worse over time.

[00:23:00] Speaker 03:
It just followed the natural course of autism.

[00:23:03] Speaker 03:
This is not a close case.

[00:23:05] Speaker 03:
As the special master noted, it was abundantly clear that petitioners' theories of causation were speculative and unpersuasive, and respondents' experts were far more qualified, better supported by the weight of the scientific research and authority, and simply more persuasive on nearly every point in contention.

[00:23:21] Speaker 03:
And that is why,

[00:23:22] Speaker 03:
The special master found her respondent on all of these issues because our case and our evidence was stronger.

[00:23:29] Speaker 03:
And that was in her role as the fact finder to do.

[00:23:32] Speaker 03:
On appeal, Judge Braden at the Court of Federal Claims could not find any error with the special master's factual findings and found her conclusions to be dispositive of the case.

[00:23:40] Speaker 03:
So she affirmed.

[00:23:42] Speaker 04:
She did take issue with something the special master did, right?

[00:23:45] Speaker 03:
She did.

[00:23:45] Speaker 03:
And we disagree.

[00:23:46] Speaker 03:
She found that the special master required medical literature to support

[00:23:52] Speaker 04:
Scientific literature.

[00:23:53] Speaker 03:
Correct.

[00:23:55] Speaker 03:
We do not believe that is the case.

[00:23:57] Speaker 03:
But because the factual issues were dispositive, that is the issue that's being addressed on appeal.

[00:24:04] Speaker 03:
But we respectfully request that this court affirm.

[00:24:06] Speaker 03:
Thank you very much.

[00:24:07] Speaker 04:
Thank you.

[00:24:18] Speaker 02:
Very briefly, Your Honors, I'd like to go back to the question of whether Millich should be revisited.

[00:24:22] Speaker 02:
whether this court should refer it to an inbound panel, because the other problem with Millic, aside from the fact that it got the preemption scope wrong and completely allows the piercing of the vaccine shield, of the liability shield for vaccine manufacturers, is that it makes an Article III ruling without referring to the central part of the Article III doctrine in Supreme Court cases.

[00:24:43] Speaker 02:
If you look at Stern, Stern versus Marshall, which is the most recent

[00:24:47] Speaker 02:
lengthy discussion of Article III.

[00:24:49] Speaker 02:
It goes through, as cases have before it, many cases, and talks about the public rights, private rights distinction.

[00:24:56] Speaker 02:
And what it says is that if you're on the private rights side of this, if there isn't a right that is inherently one against the public, then you have protection by Article III.

[00:25:07] Speaker 02:
And it goes through a number of factors.

[00:25:09] Speaker 02:
Was this a substitute for an action that existed in common law?

[00:25:12] Speaker 02:
And clearly, at this case, it was.

[00:25:15] Speaker 02:
When you have a case like this under the Vaccine Act, if there were no Vaccine Act, petitioners would be suing in state court or perhaps under diversity jurisdiction and getting in front of the jury.

[00:25:26] Speaker 02:
So it's clearly a substitute for that.

[00:25:28] Speaker 02:
When you look at other factors, such as does the federal scheme give the right to the district court to enter judgment and therefore treat the Article I court like a bankruptcy court as just advisory?

[00:25:41] Speaker 02:
And in this case, if you look at the statute, not pointed this out in the papers, it gives the Court of Federal Claims the power to enter judgment.

[00:25:49] Speaker 02:
We can appeal to this court, but that court has that power.

[00:25:52] Speaker 02:
And the Supreme Court has found that to be significant.

[00:25:55] Speaker 02:
And then it's a question of whether this is a right that is a substitute.

[00:25:59] Speaker 02:
Well, it is a substitute.

[00:26:00] Speaker 02:
The factors we went through are the factors that Stern looks at and the Supreme Court looked at in many other cases, Commodity Futures Trading Commission versus Shor, Thomas versus

[00:26:11] Speaker 02:
versus carbide, et cetera, a long line of cases in which the court looks at these factors and says, well, you're on the public rights exception side, or you're on the private rights exception side, and therefore Article III is or isn't invoked.

[00:26:25] Speaker 02:
But in Millic, there is no recognition that this distinction even exists.

[00:26:30] Speaker 02:
It's not mentioned in Millic.

[00:26:32] Speaker 02:
So what Millic does is decide a very important Article III question without acknowledging,

[00:26:40] Speaker 02:
Noting that the Supreme Court has rules for this, much less applying them, there's no reference given to this.

[00:26:46] Speaker 02:
And in that sense, even if it were to come to the same conclusion, it should do it the right way and apply the factors.

[00:26:52] Speaker 02:
But I submit respectfully that when the factors are applied, because this is the kind of case which would have been a suit against the vaccine manufacturers at common law, Article III is not irrelevant.

[00:27:05] Speaker 02:
It applies.

[00:27:05] Speaker 02:
Thank you.

[00:27:06] Speaker 02:
We thank both parties in the cases submitted.

[00:27:08] Speaker 02:
Thank you.