[00:00:00] Speaker 01:
I'm sorry, Mr. Gage.

[00:00:02] Speaker 01:
I'm going to call the major client.

[00:00:35] Speaker 03:
Good morning.

[00:00:37] Speaker 03:
May it please the court?

[00:00:40] Speaker 03:
This is a vaccine program case appeal.

[00:00:46] Speaker 03:
And it really focuses, there may be a couple things we end up arguing about, but it really focuses on the application of the Alton Prong 1 test.

[00:00:56] Speaker 03:
And Alton Prong 1 requires me, my client, to produce

[00:01:03] Speaker 03:
a medical theory causally connecting the vaccination and the injury.

[00:01:08] Speaker 03:
That's not my paraphrase.

[00:01:10] Speaker 03:
That's a direct quote out of Alton.

[00:01:14] Speaker 03:
In this case, we presented a theory that Michael McCollum, who at age 51 developed narcolepsy four to six weeks after receipt of an influenza vaccine,

[00:01:28] Speaker 03:
that the nuclear peptides create a molecular mimic between the influenza vaccine and the neurocretin receptors in the brain disturbing the sleep cycle.

[00:01:45] Speaker 03:
That particular mimic has been found and has been published.

[00:01:57] Speaker 03:
The papers, I thought you might find this interesting.

[00:02:04] Speaker 03:
There's one paper that we supplied.

[00:02:05] Speaker 03:
I'm just quoting a line from it.

[00:02:08] Speaker 03:
Among autoimmune diseases, narcolepsy is uniquely positioned to demonstrate molecular mimicry in humans, specifically between H1N1 proteins and the hypercretin cell-containing proteins.

[00:02:24] Speaker 02:
Which paper is that?

[00:02:27] Speaker 03:
You'll see that it's in footnote three of my brief.

[00:02:32] Speaker 03:
And there are three papers cited there.

[00:02:35] Speaker 03:
But that is the MAHLiOS is the name of the first author.

[00:02:47] Speaker 03:
Is there a page in the appendix on which we could find it?

[00:02:53] Speaker 03:
Certainly.

[00:02:55] Speaker 03:
It's in my brief.

[00:02:57] Speaker 03:
So let's see, appendix.

[00:03:00] Speaker 02:
I thought footnote three relates to Fang Han.

[00:03:05] Speaker 03:
Yeah, that's the first one.

[00:03:06] Speaker 03:
Look at this one.

[00:03:07] Speaker 03:
And William.

[00:03:08] Speaker 03:
And you see, I quoted that.

[00:03:10] Speaker 03:
The appendix says of 337.

[00:03:17] Speaker 03:
So I don't know if that's.

[00:03:18] Speaker 03:
I mean, I can look up and see if that has the.

[00:03:22] Speaker 02:
Well, appendix, is it?

[00:03:24] Speaker 02:
767 through 73?

[00:03:27] Speaker 03:
That's the page number for the published article.

[00:03:39] Speaker 03:
In the next footnote, on footnote four, that article looks like it was produced in its entirety in appendix 88 through 102.

[00:03:50] Speaker 03:
Antibodies to Influenza Nuclear Protein Cross-Reactive Human Hypercretin Receptor.

[00:03:58] Speaker 03:
So I just want to start with this.

[00:04:04] Speaker 03:
These are the world's leading researchers in this particular area.

[00:04:11] Speaker 03:
Narcolepsy and what's causing narcolepsy.

[00:04:14] Speaker 03:
It's being researched all over the globe.

[00:04:16] Speaker 03:
There are different groups doing that research.

[00:04:19] Speaker 03:
Some are at Stanford, some are in China, some are in England.

[00:04:23] Speaker 03:
They've published that there's an identified molecular mimic between the vaccine and the part of the brain that controls the sleep cycle.

[00:04:40] Speaker 01:
When you say that, between the vaccine

[00:04:43] Speaker 01:
and the brain, which study are you talking about and which vaccine are you talking about?

[00:04:50] Speaker 03:
Well, those particular studies that I just cited.

[00:04:53] Speaker 01:
Because the Hahn reference you cited to us doesn't have anything to do with vaccines, does it?

[00:04:57] Speaker 01:
It's the wild virus.

[00:04:59] Speaker 03:
Well, actually, and that's a good point, the fact is the thing that we know is the wild virus has in common with the vaccine that Mr. McCollum received is the H1N1 virus.

[00:05:12] Speaker 03:
The H1N1, the proteins in the H1N1 virus have to be in the vaccine in order to relay immunity.

[00:05:20] Speaker 03:
That's the thing that has the H1N1 protein in it and does not have an adjuvant in it is the wild virus.

[00:05:29] Speaker 03:
So he got that particular protein from that vaccine.

[00:05:34] Speaker 03:
I mean, there's no other way, at least in the record, for him to have received that.

[00:05:38] Speaker 03:
But I cited,

[00:05:41] Speaker 03:
probably a half dozen of those research articles in there.

[00:05:45] Speaker 03:
Those two footnotes, I think, contain five of them.

[00:05:49] Speaker 03:
But let's just.

[00:05:51] Speaker 01:
Can I just clarify, though, because it's my understanding of the record and the special master's opinion is that there's no direct study linking the US vaccine to narcolepsy.

[00:06:07] Speaker 03:
Yeah, no, I don't believe that that's correct, Your Honor.

[00:06:11] Speaker 01:
Well, which study can you point me to, then?

[00:06:14] Speaker 02:
Well, I mean... But that's correct in terms of what the special master determined.

[00:06:20] Speaker 02:
I mean, Judge Hughes correctly recited what the special master found.

[00:06:26] Speaker 02:
You're taking issue with the special master.

[00:06:28] Speaker 03:
Well, I am doing that also.

[00:06:30] Speaker 03:
However, for instance, the...

[00:06:36] Speaker 03:
The article at the appendix at page 95, when we're talking about the MP content, that's the thing that causes the molecular mimic.

[00:07:03] Speaker 03:
between the hypocretin cells and the H1N1 virus is the nuclear protein within the H1N1 virus itself.

[00:07:15] Speaker 03:
So the vaccines that were given in this country, if you look at page 95 of the appendix, that list there, the pandemrix, which was not given in this country, is on the bottom, and that's for comparison.

[00:07:29] Speaker 03:
But the NP content for all the other, these are all

[00:07:33] Speaker 03:
influence of vaccines that are given in this country?

[00:07:36] Speaker 03:
I mean, that's what they were studying there.

[00:07:39] Speaker 03:
And so this paper directly looked at that question.

[00:07:43] Speaker 03:
Vaccines given to people in this country, do they have a similar NP content, or how high are their NP content?

[00:07:51] Speaker 03:
Some are high and similar.

[00:07:53] Speaker 03:
In fact, one is higher than the pandemics.

[00:07:57] Speaker 03:
There were some that were lower.

[00:07:58] Speaker 01:
So let me see if I understand this.

[00:08:00] Speaker 01:
Your theory is that

[00:08:03] Speaker 01:
Ahmed to suggest that the NP factor is the critical factor for narcolepsy.

[00:08:11] Speaker 01:
And that there's ample evidence that the US vaccine has higher NP factor than the pandemrix study, which did show a connection between a different form of the vaccine in England versus here.

[00:08:30] Speaker 03:
I almost agree with that.

[00:08:31] Speaker 03:
Some were high, but not as high.

[00:08:34] Speaker 03:
There was one that was higher.

[00:08:36] Speaker 03:
Some were kind of in the mid-range.

[00:08:38] Speaker 03:
But the research was designed to show, I mean, the hypothesis of these researchers that this publication was, that it's the MP content that's doing it.

[00:08:51] Speaker 03:
They found the molecular mimic in the nuclear protein, the MP.

[00:08:55] Speaker 03:
It's not in an adjuvant.

[00:08:57] Speaker 03:
It's in the MP.

[00:08:58] Speaker 03:
And people in this country are being injected with that.

[00:09:02] Speaker 03:
In the follow-up, when we did our motion to reconsider, and I'm going to try and pronounce the name of that article, but it's Samak Tabun, I think.

[00:09:12] Speaker 01:
Does AMED 2 rule out the adjuvant or just suggest that the NP along with the adjuvant is what's causing the problem?

[00:09:25] Speaker 03:
It just suggests that the NP is the trigger for narcolepsy.

[00:09:30] Speaker 01:
They did not... It doesn't say it's the sole trigger.

[00:09:34] Speaker 03:
They did not attempt to rule out an adjuvant.

[00:09:39] Speaker 03:
That wasn't what they were trying to do.

[00:09:41] Speaker 03:
They were trying to show that they found what they said, okay, we found the mimic, which is a big deal in their portion of science.

[00:09:50] Speaker 03:
Look, we've identified it here.

[00:09:52] Speaker 03:
They go through genetic coding.

[00:09:54] Speaker 03:
We found enough genetic code.

[00:09:56] Speaker 03:
This is enough to confuse the immune system, cause narcolepsy.

[00:10:00] Speaker 03:
So let's look at the vaccines that were given in this country.

[00:10:04] Speaker 03:
Do any of them have high MP contents?

[00:10:07] Speaker 03:
And they said, well, look at this.

[00:10:08] Speaker 03:
We have at least several of them that do.

[00:10:11] Speaker 03:
And so that was their hypothesis with that particular article.

[00:10:15] Speaker 03:
But let's take a step back from that.

[00:10:19] Speaker 03:
The special master found that

[00:10:31] Speaker 03:
The NPs proposed by some of the reliable literature should be the trigger for the autoimmune process.

[00:10:39] Speaker 03:
Where is this?

[00:10:40] Speaker 03:
This is on page 22 of his decision, page 23 of the appendix.

[00:10:45] Speaker 03:
Then in the third paragraph down on that page, he talks about his earlier decision, the DTO.

[00:10:52] Speaker 03:
He says, the general theory that certain formulations of H1N1-containing flu vaccines

[00:10:58] Speaker 03:
can cause narcolepsy due to their NP content has several reliable components.

[00:11:06] Speaker 03:
So that's from my question to this panel, of course, is how is that not a theory that is, how do I not, how have I not set aside out in step one with presenting a theory when he talks about my theory and he does so

[00:11:26] Speaker 03:
and says that there are several reliable, whatever the words were, reliable components to that which he's talking about medical articles.

[00:11:37] Speaker 01:
But he then goes on and suggests that some of that evidence at least is based upon a different vaccine.

[00:11:48] Speaker 03:
No, our

[00:11:51] Speaker 03:
theory on the AMP content is from that table that we just got through looking at on page nine to five of the appendix.

[00:12:05] Speaker 01:
I know, but I'm looking at what you're reading from his report.

[00:12:08] Speaker 01:
He agrees that there are theories out there, but then suggests that certain formulations can do it, but then those aren't based upon the American vaccine.

[00:12:21] Speaker 03:
The theories that we're talking about are that table are based on the American vaccines.

[00:12:27] Speaker 03:
That's why that table was put there.

[00:12:30] Speaker 01:
OK.

[00:12:30] Speaker 01:
You're into your rebuttal.

[00:12:31] Speaker 01:
Do you want to continue or save time?

[00:12:34] Speaker 03:
Well, I want to say a couple of things.

[00:12:37] Speaker 03:
We know what his, the reason he didn't, it's a real reason for this appeal.

[00:12:45] Speaker 03:
If I was just here saying, why don't I convince you that vaccines cause narcolepsy, I would assume I would have an uphill battle.

[00:12:55] Speaker 03:
That's not what this appellate court is here for.

[00:12:59] Speaker 03:
I want you to enforce Alton's Pong 1.

[00:13:01] Speaker 03:
I mean, it's really that simple.

[00:13:04] Speaker 03:
We don't have to guess what the special master is thinking.

[00:13:07] Speaker 03:
He tells us.

[00:13:08] Speaker 03:
He says that petitioner offered no direct evidence suggesting that the version of the vaccine that he received

[00:13:15] Speaker 03:
has been tested in connection with narcolepsy to the degree other vaccines Pandemrix has.

[00:13:22] Speaker 03:
That is the standard he put up.

[00:13:24] Speaker 03:
We didn't produce evidence that the vaccines in this country have been tested to the extent that Pandemrix was.

[00:13:32] Speaker 03:
And then he said that we did not wholly eliminate the adjuvant as possibly playing an important role.

[00:13:41] Speaker 03:
ALTIN doesn't require me to show the testing to any particular level, and I don't have to wholly eliminate anything.

[00:13:52] Speaker 03:
That bar is set so high that no vaccine petitioner would ever get over that bar.

[00:13:59] Speaker 03:
How do I wholly eliminate other possibilities?

[00:14:03] Speaker 03:
How do I do that?

[00:14:05] Speaker 03:
How do I wholly eliminate an adjuvant from a vaccine that isn't even used in this country?

[00:14:11] Speaker 03:
There's no publications on it.

[00:14:12] Speaker 03:
People don't research that sort of thing.

[00:14:16] Speaker 03:
We have a 51-year-old man who developed narcolepsy four to six weeks after receiving a vaccine.

[00:14:23] Speaker 03:
And this is a childhood or adolescent disease.

[00:14:25] Speaker 03:
He should not have developed narcolepsy then.

[00:14:28] Speaker 03:
He had another vaccine.

[00:14:33] Speaker 03:
And he had a spike in his symptoms.

[00:14:35] Speaker 03:
And we put all, and I want to just put that out there, we put all that evidence on.

[00:14:39] Speaker 03:
We elicited testimony on it.

[00:14:41] Speaker 03:
We submitted medical records.

[00:14:42] Speaker 03:
We had the people who were the McCollums testifying about what they did with their doctor.

[00:14:52] Speaker 03:
We did not waive that argument.

[00:14:54] Speaker 03:
And he did not address it.

[00:14:56] Speaker 03:
So I just leave that there.

[00:14:57] Speaker 03:
But if special masters are free under Alton to say,

[00:15:04] Speaker 03:
I'm going to require you to go out and do research or find research that wholly eliminates a potential cause.

[00:15:15] Speaker 03:
We can't win any vaccine case.

[00:15:17] Speaker 03:
We would only win table cases.

[00:15:19] Speaker 03:
There are no cause and fact cases.

[00:15:20] Speaker 03:
We can't meet that standard.

[00:15:23] Speaker 03:
And to show that, I mean, this court has said numerous times that we don't have to do epidemiological studies.

[00:15:30] Speaker 03:
It's the whole reason between with Alton and Capizano.

[00:15:33] Speaker 03:
We don't have to do that.

[00:15:34] Speaker 03:
And what he required was epidemiology.

[00:15:37] Speaker 01:
Mr. Gage, you've completely exhausted your time.

[00:15:40] Speaker 01:
Let's hear from the government.

[00:15:41] Speaker 01:
I'll restore two minutes.

[00:15:42] Speaker 00:
May it please the court.

[00:15:57] Speaker 00:
My name is Robert Coleman.

[00:15:58] Speaker 00:
I represent the Respondent Secretary of Health and Human Services.

[00:16:01] Speaker 01:
Can I just ask you this?

[00:16:02] Speaker 01:
If the special master had reached

[00:16:04] Speaker 01:
completely opposite conclusion that this medical evidence showed a theory that was sufficient under ALT and 1.

[00:16:13] Speaker 01:
Would that have been arbitrary and capricious?

[00:16:17] Speaker 00:
I believe it would, primarily because there is evidence here.

[00:16:20] Speaker 00:
The evidence here is insufficient to show that the actual type of vaccine that was administered to the petitioner causes narcolepsy.

[00:16:27] Speaker 00:
That's the primary problem.

[00:16:28] Speaker 01:
We know that.

[00:16:29] Speaker 01:
I mean, the English study seems

[00:16:33] Speaker 01:
pretty conclusive that the English vaccine does cause narcolepsy, right?

[00:16:38] Speaker 01:
If this was the English vaccine, we wouldn't be here.

[00:16:42] Speaker 01:
So then we have the two Canadian studies that suggest looking at that English study that really what's causing it there is primarily the protein.

[00:16:51] Speaker 01:
And I suspect you dispute that characterization.

[00:16:55] Speaker 01:
Let's assume that's what it says.

[00:16:57] Speaker 01:
And then we go to the American vaccine and we know it has

[00:17:02] Speaker 01:
and maybe I'm wrong about this, but I don't think I am, that it has protein levels comparable to or higher than the English study.

[00:17:10] Speaker 01:
Why isn't those three studies put together if the special master had made that finding a sufficient theory of causations?

[00:17:19] Speaker 00:
primarily because there's other evidence in the record as well, indicating, for instance, that the- Right, right, I get that.

[00:17:25] Speaker 01:
But isn't that the special master's job?

[00:17:27] Speaker 01:
That's why I ask it to you in that way.

[00:17:29] Speaker 01:
If the special master's balances all this evidence and says, well, yeah, there may be this epidemiological study, but we kind of discount epidemiological studies.

[00:17:40] Speaker 01:
There's nothing else that suggests that the adjuvant is the key role.

[00:17:44] Speaker 01:
It seems to go the other way.

[00:17:45] Speaker 01:
So I'm going to find this is sufficient.

[00:17:48] Speaker 01:
I get that he didn't and you think that's not arbitrary and capricious but I just don't understand why you'd say if he came out the other way that that would be arbitrary and capricious.

[00:17:58] Speaker 00:
And it would be a close call and there would be a reasonable argument though I believe from respondent that it is arbitrary and capricious because of the other evidence that outweighs the evidence that petitioner.

[00:18:10] Speaker 00:
And what evidence is that?

[00:18:12] Speaker 00:
Primarily there are four particular studies

[00:18:15] Speaker 00:
They're addressed, two of them are addressed on page 16 of the appendix.

[00:18:18] Speaker 00:
This is the Utiborala study and the Partanen II study.

[00:18:21] Speaker 00:
And on page 37 of the appendix, there's the R. Vandermoos study and the third Ahmed article.

[00:18:27] Speaker 00:
And all four of those articles to an extent.

[00:18:30] Speaker 00:
What about the Duffy study?

[00:18:31] Speaker 00:
And Duffy as well.

[00:18:33] Speaker 00:
So these five articles, four of them are not the epidemiologic study.

[00:18:39] Speaker 00:
The epidemiologic study is separate.

[00:18:41] Speaker 00:
The fourth studies indicate that to a greater or lesser extent, that basically it's a dual effect between the high nuclear protein content and adjuvant.

[00:18:51] Speaker 00:
So that it's the presence of the adjuvant that somehow contributes to the triggering of narcolepsy.

[00:18:57] Speaker 00:
Without one or the other of those factors, we don't have narcolepsy as a result of vaccination.

[00:19:02] Speaker 00:
And that is supported by the Duffy study, which is a large scale epidemiologic study

[00:19:07] Speaker 00:
and the only evidence that directly addresses the type of vaccination the petitioner received here.

[00:19:12] Speaker 01:
But isn't the Hahn study contradictory to that because it suggests that the wild virus can trigger narcolepsy where there isn't an adjuvant?

[00:19:23] Speaker 00:
Yes, to an extent, it does contradict.

[00:19:25] Speaker 00:
However, there are problems with the Hahn study's reliability, which the special master addresses on page 12 and 13 of the appendix in and of itself, but additionally,

[00:19:34] Speaker 00:
The Hans study involves just the wild version of the virus.

[00:19:37] Speaker 00:
And on page 24 of the appendix, the special master indicated that here it's uncontested that petitioner received an inactivated version of the vaccine.

[00:19:46] Speaker 00:
So we're not dealing with the wild version of the virus.

[00:19:50] Speaker 00:
The wild version of the virus can have effects that the vaccine will not have, primarily because that vaccine involves a version of the virus that's inactivated, weakened, in order to use it in a vaccine.

[00:20:05] Speaker 00:
Because the special master here reviewed all of the reliable evidence and drew plausible inferences from that evidence and provided a rational basis for his decision, the respondent respectfully requests that this court affirm.

[00:20:21] Speaker 00:
Thank you.

[00:20:21] Speaker 00:
Thank you very much.

[00:20:34] Speaker 03:
Your Honors, I remember when the Stevens analysis came out from Special Master Galkowitz in this program since its inception, where he set two extra standards for petitioners to prove their case.

[00:20:54] Speaker 03:
And then Alvin came out and said, Special Masters don't get to set standards.

[00:20:58] Speaker 03:
They have to enforce the law.

[00:21:01] Speaker 03:
The standards set in Stevens are in fact significantly lower than the standard that Special Master Corcoran has set in this case.

[00:21:09] Speaker 03:
And Steven, Special Master Galkowicz just said, give me some published, I want published literature and I want this to be accepted in the medical community at least at some level.

[00:21:21] Speaker 03:
this court and Alton said, you can't do that.

[00:21:25] Speaker 03:
The irony, of course, is here we have the best researchers in the world on this subject publishing on this, saying that it's the MP content that does this.

[00:21:37] Speaker 03:
And we have a petitioner who is at the Stanford Sleep Study.

[00:21:42] Speaker 01:
Well, wait, you say that, but then you don't cite to any study that says it's the MP

[00:21:48] Speaker 01:
component alone, and your friend on the other side cited to some studies that suggest it's the NP in combination with adjuvant.

[00:21:59] Speaker 03:
Not only the HAN, but Jamak-Jabun, I'm sorry how I pronounce that, both deal with non-adjuvant.

[00:22:08] Speaker 01:
Well, sure, but HAN's the wild virus.

[00:22:10] Speaker 01:
So I don't see how it's arbitrary to purchase a treat that different than a vaccine.

[00:22:16] Speaker 01:
What's the other one you're talking about?

[00:22:18] Speaker 03:
The one we filed in relation to the motion to reconsider.

[00:22:23] Speaker 03:
And the special master saw that as a wild virus, although I don't believe that is.

[00:22:30] Speaker 03:
But the question's easier, Your Honors.

[00:22:34] Speaker 03:
Can the special master make me wholly eliminate a potential alternate cause?

[00:22:40] Speaker 03:
I mean, it's scientifically impossible.

[00:22:43] Speaker 03:
We don't have to speculate.

[00:22:44] Speaker 03:
That's what he said he wanted.

[00:22:46] Speaker 03:
I can't do it.

[00:22:49] Speaker 03:
And he says that I have to show that the vaccines that my client got has to be tested to the same level.

[00:22:59] Speaker 03:
Many of these vaccines never get tested, especially the new ones.

[00:23:04] Speaker 03:
We deal with these things where the first post-licensure study hasn't even come out when the case is filed.

[00:23:12] Speaker 03:
How do I do that?

[00:23:14] Speaker 03:
He has set a standard that is so high, I cannot reach that standard.

[00:23:19] Speaker 03:
And that violates Alton.

[00:23:21] Speaker 03:
It violates not only the language, but the reason for Alton was because the case before that, Stevens, was setting standards that we had to meet.

[00:23:30] Speaker 03:
The special master said, do that.

[00:23:32] Speaker 03:
I don't care what the vaccine is.

[00:23:34] Speaker 03:
And I know I'm over my time, and I apologize.

[00:23:38] Speaker 03:
But I don't care what the vaccine is.

[00:23:41] Speaker 03:
If I have to wholly eliminate

[00:23:43] Speaker 03:
other possible causes, I cannot win any cases.

[00:23:47] Speaker 01:
It doesn't matter.