[00:00:00] Speaker 02:
The next case is Ronald Weiss versus the Secretary of HHS, 2024-1472.

[00:00:10] Speaker 02:
Ms.

[00:00:10] Speaker 02:
Ruckel.

[00:00:14] Speaker 01:
Ms.

[00:00:14] Speaker 01:
Rockmore.

[00:00:15] Speaker 01:
Good morning, Your Honors.

[00:00:17] Speaker 01:
As you said, Lisa Rockmore here for the petitioner, Ron Roint, and the appellant here in this case.

[00:00:27] Speaker 01:
Topics here, we're talking about the vaccine program.

[00:00:31] Speaker 01:
And in the vaccine program, we are always talking about very rare events.

[00:00:37] Speaker 01:
In the case of Guillain-Barre, which you'll also hear talked about as GBS, some infections are always have an increased statistical rate of causing GBS than an influenza vaccine.

[00:00:53] Speaker 01:
Mr. White, in this case, had the influenza vaccine.

[00:00:57] Speaker 01:
which led to GBS within the appropriate period of time, which made it what we call a table case that gives us the presumption of causation.

[00:01:07] Speaker 02:
But there is fact finding here and a predominance of the evidence standard.

[00:01:14] Speaker 02:
And the issue was sole substantial cause.

[00:01:18] Speaker 02:
And the special master found that the sole substantial cause was H flu, not influenza vaccine, H flu bacterial infection.

[00:01:29] Speaker 01:
He did absolutely find that.

[00:01:31] Speaker 01:
And we believe there was a legal error in doing so, because it was in contravention of this court's case law in Knudsen, Shyface, Walther, where

[00:01:48] Speaker 01:
The respondent has the burden of proof, because the burden did transfer over to them.

[00:01:56] Speaker 01:
They have the burden of proof of showing that their alternative factor, the H influenza, was the sole substantial cause, and that the influenza vaccine could be excluded.

[00:02:13] Speaker 00:
And that particular question that you addressed, that is a factual question, correct?

[00:02:18] Speaker 01:
No, I believe it's legal error.

[00:02:21] Speaker 01:
There is some, I'm going to call it questions of fact, but I think there's legal error by ignoring the edicts of this court that you cannot use statistics in order to find that an alternative factor was the sole substantial cause of, in this case, the GBS.

[00:02:44] Speaker 03:
Have we said that we can't use statistics?

[00:02:47] Speaker 01:
This is a separate discussion from, obviously, part of the burden of proof of the respondent is that they must first, as a foundational matter, prove their Alphen prongs.

[00:03:05] Speaker 01:
They did not.

[00:03:06] Speaker 01:
They did not present any evidence on prong one.

[00:03:10] Speaker 03:
I thought they pointed to a whole bunch of literature that showed that the H flu infection can cause GBS.

[00:03:24] Speaker 03:
Did they not?

[00:03:26] Speaker 01:
They did point to a bunch of literature, not a bunch.

[00:03:31] Speaker 01:
Three specifically that deal with H influenza.

[00:03:36] Speaker 01:
The others kind of broad brushed and combined

[00:03:40] Speaker 01:
Influenza like infections, but we're talking about h influenza and to your question the Alphen prongs the the literature deals did not deal with a Medical reasonable medical theory it talks about associations it talks about statistics it does not tell us and nor did

[00:04:09] Speaker 01:
The expert forerespondent have in her expert report any medical theory.

[00:04:17] Speaker 01:
She relied solely on the articles that deal with statistically

[00:04:24] Speaker 03:
H influenza and I understand all from prong one to be is there evidence of a medical theory causally connecting here the H influenza and GPS yes yes so have we said that you can't rely on statistics at that step one letter of prong one I have not seen a case before

[00:04:53] Speaker 01:
either from the Federal Circuit, from the offices of the Special Masters, or from the Federal Court of Claims that says that you can rely on statistics in order to meet your prong one.

[00:05:05] Speaker 01:
In fact, the Chief Special Master puts petitioners feet to the fire significantly in order to show things like not only just molecular mimicry because

[00:05:20] Speaker 01:
The recitation of molecular mimicry is insufficient from his particular standpoint in terms of proving what a reasonable medical theory is.

[00:05:35] Speaker 01:
So you have to have something more than just cases or studies that say, statistically, this can happen.

[00:05:43] Speaker 01:
How?

[00:05:44] Speaker 01:
How, in this case, you must show, how can it happen?

[00:05:49] Speaker 01:
And that didn't occur in this case.

[00:05:52] Speaker 03:
My understanding of prong two is a logical sequence of cause and effect showing that here the infection is the reason for Mr. White's GBS specifically.

[00:06:03] Speaker 03:
Is that a fair understanding of what the step two analysis would be with the burden on the government?

[00:06:12] Speaker 01:
The first prong is, in simple terms, can it.

[00:06:17] Speaker 01:
The second prong is,

[00:06:19] Speaker 01:
Did it.

[00:06:20] Speaker 01:
Right.

[00:06:20] Speaker 03:
And the special master here says you didn't have any challenge at prom 2 that did it.

[00:06:27] Speaker 03:
Is that a fair description of your position?

[00:06:31] Speaker 01:
We would disagree.

[00:06:32] Speaker 01:
I think our position was because they did not show, respondent, that is, either prom 1 or prom 3, that you could not also meet prom 2.

[00:06:43] Speaker 03:
And that's what you say at page 37 of your brief.

[00:06:46] Speaker 03:
But if we were to find, under the standard of review, that they did do enough at one and three, you don't have a separate argument that they failed at Prop 2.

[00:06:56] Speaker 03:
Is that right?

[00:06:58] Speaker 01:
I think based on prior federal circuit law decisions like in Capizano, and I think there was a footnote in Sharp as well, that it's not

[00:07:11] Speaker 01:
completely clear, but it's, I would say, intimated that if you make prong one and if you make prong three, you could likely make prong two if you have those other two.

[00:07:24] Speaker 01:
It's not as clear as that under Caposano and Sharp, because in Sharp it was a footnote.

[00:07:30] Speaker 01:
I think it was footnote five.

[00:07:34] Speaker 01:
But I believe that if you have one and three,

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there's intimation that you could make prong to.

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Going back to soul and substantial cause, let's just say that respondent was able to meet their health and prongs.

[00:07:55] Speaker 01:
That's a foundational matter that we contend and submit did not occur.

[00:08:01] Speaker 01:
That doesn't end the analysis.

[00:08:03] Speaker 01:
The analysis then is, did respondent

[00:08:08] Speaker 01:
in proving their alternative factors show that the vaccine was the sole, that's an important word, substantial cause, and that they could exclude the vaccine.

[00:08:20] Speaker 01:
And obviously we submit that they could not and did not.

[00:08:25] Speaker 01:
If they take out, if you take out the articles that I'll discuss statistically, which in Knudsen and Shyface and Walther, this court has rejected,

[00:08:37] Speaker 01:
statistics as being able to show so and substantial cause.

[00:08:42] Speaker 01:
If you take out the statistics, then there is, what we submit, no evidence of how the vaccine had no role other than a conclusion that had no foundation and no explanation of how one excluded the flu vaccine.

[00:09:06] Speaker 02:
The Special Master did find as fact that medical records established that H. flu likely, likely, predominance of the evidence, did cause his GPS.

[00:09:20] Speaker 02:
More conclusive evidence came from sputum findings and x-ray findings.

[00:09:26] Speaker 02:
These aren't statistics.

[00:09:28] Speaker 02:
These relate to evidence with respect to Mr. White.

[00:09:35] Speaker 01:
For purposes of this appeal, we are not arguing whether or not Mr. White had H influenza.

[00:09:47] Speaker 02:
What we are arguing is... But the special master found that it caused GBS.

[00:09:58] Speaker 01:
The word that you used was appropriate, likely caused, and likely caused

[00:10:05] Speaker 01:
is not more likely than not.

[00:10:08] Speaker 01:
It's not the higher standard or higher burden.

[00:10:14] Speaker 01:
Likely is more like possible.

[00:10:16] Speaker 01:
And I would point out to this court that even the article submitted by respondent in support that the H influenza can cause GBS

[00:10:33] Speaker 01:
Very clearly, like in Ju, J-U, I don't know if I'm pronouncing it correctly, it even in its title says possible, can possible cause GBS.

[00:10:49] Speaker 01:
It also used the words rare.

[00:10:52] Speaker 01:
It rarely caused GBS.

[00:10:56] Speaker 01:
Never mind that this was a UK study.

[00:10:59] Speaker 01:
It wasn't a study about this particular influenza vaccine.

[00:11:04] Speaker 01:
and that they found it was non-encapsulated H-influenza.

[00:11:10] Speaker 01:
We don't know what type of H-influenza we have here, but the reason why they used the word rare and possible is that when you look at their P-value, which is an incident rate of how often from their study, which is their small studies, and again we're talking about rare events,

[00:11:33] Speaker 01:
But from their number of people, their incident rate was 0.06, not even a 1%.

[00:11:40] Speaker 01:
0.06.

[00:11:43] Speaker 01:
Now you can compare that to the IOM, the Institute of Medicine, which you'll find in the appendix 645 to 649, which has a very nice chart of the influence of vaccines

[00:12:02] Speaker 01:
And the different cases and their incident rates their p-values are Consistently higher than the h influenza articles that are cited by respondents such as stow stow had a point seven six that's seven percent higher than the h influenza Also, you're into your bottle time you can continue or save it all a mixture of the time I will save it for rebuttal, but thank you all right

[00:12:33] Speaker 02:
Mr. Stein.

[00:12:41] Speaker 04:
Good morning.

[00:12:42] Speaker 04:
Good morning.

[00:12:51] Speaker 04:
May I place the court?

[00:12:53] Speaker 04:
Chief Special Master properly denied Petitioner's vaccine injury claim based on his determination that respondent carried his burden of proving alternative causation by preponderance of the evidence.

[00:13:03] Speaker 04:
Respondent established that a factor unrelated to petitioners November 1st, 2017 flu vaccine, namely an ongoing upper respiratory infection caused by the influence of bacterial infection, was principally responsible for causing petitioners' GBS.

[00:13:17] Speaker 04:
In reaching this determination, the Chief Special Master comprehensively addressed the evidence of record

[00:13:21] Speaker 04:
applied the appropriate legal standard and articulated reasoned and supported explanations for his determination.

[00:13:26] Speaker 04:
Contrary to appellant's arguments, the chief special master properly applied the Alton test.

[00:13:32] Speaker 04:
Finding that respondent preponderantly showed that the age flu infection can cause GBS and did cause petitioner's GBS within a medically acceptable time frame.

[00:13:39] Speaker 04:
Moreover, he clearly explained that the record preponderantly showed that petitioner's age flu infection was principally responsible for causing his GBS

[00:13:47] Speaker 02:
Is there a difference between likely and highly and very likely?

[00:13:52] Speaker 02:
And is likely not meet the preponderance test?

[00:13:57] Speaker 04:
Well, I believe the chief in this decision used more likely than not throughout his decision.

[00:14:01] Speaker 04:
And that clearly tracks with the preponderance standard.

[00:14:03] Speaker 04:
I think likely probably would too, but to the extent the argument is that

[00:14:08] Speaker 04:
the Chief Special Master did not use the language that tracks with the preponderance center.

[00:14:14] Speaker 04:
That's just not true.

[00:14:16] Speaker 04:
It's throughout the opinion, preponderance, more likely than not.

[00:14:20] Speaker 03:
But what had to be found by the preponderance was more likely than not that the H flu infection was the sole substantial factor in Mr. White's GBS.

[00:14:32] Speaker 00:
Correct.

[00:14:33] Speaker 03:
You agree that's the burden

[00:14:35] Speaker 03:
And it's your view that the special master applied that and held you to that burden?

[00:14:41] Speaker 04:
Correctly applied the burden and the factual determinations underlying that are subject to the arbitrary and capricious injury.

[00:14:48] Speaker 03:
And in meeting your burden, do you have to meet all three often prongs with respect to the

[00:14:55] Speaker 03:
flu infections?

[00:14:56] Speaker 04:
Yes, Your Honor.

[00:14:57] Speaker 04:
So once a prima facie case is established, the burden does shift to respondent.

[00:15:01] Speaker 04:
The respondent is held to the same burden under Alton to prove by preponderance of the evidence, Alton's prong 1 through 3.

[00:15:08] Speaker 04:
In addition to that, respondent must prove more likely than not or by preponderant evidence that the factor unrelated was principally responsible.

[00:15:17] Speaker 04:
That's in tracking with the statute or in the sports case law in Knudsen.

[00:15:21] Speaker 04:
the sole substantial factor and thus excluding the vaccine as a substantial factor also by a preponderance.

[00:15:29] Speaker 04:
And more likely than not, the vaccine was not a substantial factor.

[00:15:32] Speaker 03:
Did you rely on statistics in meeting your burden under any of the often prongs?

[00:15:37] Speaker 03:
And if so, what case of ours allows you to do that?

[00:15:41] Speaker 04:
Well, I'm not aware of any case that does not allow, but what responders relied on was case control studies, peer review studies, epidemiological studies.

[00:15:51] Speaker 04:
Epidemiology is based in statistics.

[00:15:54] Speaker 04:
It's well established in this court's precedent that a respondent and claimant, petitioner alike, may present epidemiological evidence.

[00:16:01] Speaker 04:
that's relevant evidence that can be considered.

[00:16:03] Speaker 04:
In fact, it's some of the highest form of evidence.

[00:16:06] Speaker 04:
In many cases, petitioners don't have these types of studies that we presented here.

[00:16:11] Speaker 04:
And that's why they rely on a biological mechanism of causation.

[00:16:15] Speaker 04:
My friend on the other side was alluding to molecular mimicry.

[00:16:17] Speaker 04:
And I think my friend on the other side confuses biological mechanism with a medical theory, which is the burden under Alphen.

[00:16:25] Speaker 04:
And that's what we presented with rigorous studies that, in addition to Jew, which

[00:16:31] Speaker 04:
I'll point out that Petitioner's Expert agreed shows an association between H. flu and GBS, that's the concession on ALFIN 1.

[00:16:41] Speaker 04:
We presented additional articles that show more persuasively the association in which Petitioner's Expert did not

[00:16:49] Speaker 04:
did not take up in his reports.

[00:16:52] Speaker 04:
Again, the Chief Special Master discussed all this evidence.

[00:16:55] Speaker 04:
I don't believe there's an allegation that over looked in it.

[00:16:57] Speaker 03:
At all, it would seem you shouldn't be able to use statistics because it's always going to be more likely that what caused any particular petitioners here at GBS is

[00:17:15] Speaker 03:
you know, say an infection as opposed to the vaccine, because the vaccine incidents rapidly are rare.

[00:17:22] Speaker 03:
So it would seem wrong to allow you to use statistics to meet your burden at Alton Prong 2.

[00:17:30] Speaker 03:
Did you do that here?

[00:17:31] Speaker 04:
That wasn't... Sorry, you're on.

[00:17:33] Speaker 03:
And have we ever addressed that?

[00:17:34] Speaker 04:
You know, that wasn't done here on ALP and Proline 2.

[00:17:38] Speaker 04:
The chief primarily relied on the clinical picture, Petitioner's medical records, buttressed by our infectious disease experts' review and opinions on that, that most notably, Petitioner had contemporaneous with the onset of his symptoms, attributed the TBS to an infection, to the H flu infection.

[00:17:55] Speaker 04:
That's 14 treating providers.

[00:17:57] Speaker 04:
It's quite a lot, all contemporaneous with the onset of the symptoms, the hospitalization,

[00:18:03] Speaker 04:
So for Altenprong 2, the chief relied on the clinical picture, the medical records.

[00:18:09] Speaker 04:
And I think there was some discussion earlier about a case where it's Andreu.

[00:18:13] Speaker 04:
If Altenprong 1 and 3 are met, the opinion of treating providers on the logical sequence cause and effect, Alten 2, are quite probative.

[00:18:22] Speaker 03:
Here, though, it seemed like early on in the treatment records, at least at the hospital, the records mistakenly said that Mr. White had not received the vaccine in the pertinent year.

[00:18:38] Speaker 03:
Isn't it possible that that influenced the treater's initial views that a vaccine, of course, couldn't have been the cause of the GBS because there was no vaccine administered?

[00:18:51] Speaker 04:
I don't know.

[00:18:52] Speaker 04:
I mean, it'd be respectful to say so.

[00:18:53] Speaker 04:
I don't know what we would do with that fact.

[00:18:56] Speaker 04:
The chief special master considered that evidence.

[00:18:59] Speaker 04:
He didn't find it persuasive as to undermining 14 other treating providers that did attribute GBS with the vaccine.

[00:19:08] Speaker 04:
And again, I don't know if that's a

[00:19:12] Speaker 04:
Again, it's evidence that's addressed.

[00:19:14] Speaker 04:
It would have to be a factual determination that was clearly wholly implausible or arbitrary, capricious to reverse that finding.

[00:19:27] Speaker 02:
Thank you, counsel.

[00:19:29] Speaker 04:
Thank you, Your Honor.

[00:19:30] Speaker 02:
There's Rob Moore from Rebuttal Time.

[00:19:58] Speaker 01:
We disagree that likely, word like likely, and probably meet.

[00:20:04] Speaker 02:
Could you speak up?

[00:20:05] Speaker 01:
I'm sorry.

[00:20:06] Speaker 01:
We disagree that the words likely or probably meet the standard of more likely than not.

[00:20:14] Speaker 01:
And if my memory serves me, the chief special master discussed that the vaccine likely could be excluded.

[00:20:27] Speaker 01:
the words in his decision.

[00:20:31] Speaker 01:
In regard to the treatment records early on, mistakenly saying there was no influence, we absolutely submitted and agree that that had an influence on later medical records.

[00:20:45] Speaker 01:
If it's incorrect at the beginning, as I think we probably have all had in our medical records, it just follows you until you finally see a report by the

[00:20:57] Speaker 01:
a petitioner that he did have an influenza vaccine.

[00:21:02] Speaker 01:
And then later on, you could see in the records, even though it was six months later, the treaters saying that the influenza vaccine and the H influenza caused the GBS both together.

[00:21:18] Speaker 01:
You can't tell the difference.

[00:21:20] Speaker 01:
Again, we're talking about two rare events.

[00:21:24] Speaker 01:
I think even the H influenza is rarer

[00:21:27] Speaker 01:
by the statistics, if we're going to look at statistics, than the influenza vaccine.

[00:21:33] Speaker 01:
But if we're talking about two rare events, we are at best, we cannot tell which one caused the GBS.

[00:21:42] Speaker 01:
When you cannot tell which caused the GBS, we are in what we call, and as the court has called, equipoise.

[00:21:50] Speaker 02:
Counsel, on page two of the Special Master's opinion, with respect to your first point, Special Master says, having reviewed the medical records, expert reports, and associated literature, I deny an entitlement award.

[00:22:07] Speaker 02:
A respondent has carried his burden of showing that a factor unrelated was the more likely explanation.

[00:22:16] Speaker 02:
More likely.

[00:22:19] Speaker 02:
That meets preponderance, does it not?

[00:22:21] Speaker 01:
More likely, yes.

[00:22:23] Speaker 01:
Those words.

[00:22:24] Speaker 01:
Later on in his decision, I don't have the exact page number, but I did indicate it in the appellate brief and or the reply that he later said that it could likely exclude the flu vaccine.

[00:22:41] Speaker 01:
It's not just sole substantial cause.

[00:22:46] Speaker 01:
This court has also included words as

[00:22:49] Speaker 01:
exclude, it excludes the vaccine.

[00:22:52] Speaker 01:
You'll see that in Walter.

[00:22:54] Speaker 01:
You'll see that in other Federal Circuit cases.

[00:23:01] Speaker 01:
And again, I think because we're talking about rare events, we are in equipoise.

[00:23:07] Speaker 01:
And when we are in equipoise, then you have to look at who has the burden.

[00:23:11] Speaker 01:
And in this case, the burden squarely lies on respondent.

[00:23:16] Speaker 01:
And we submit it was not met

[00:23:19] Speaker 01:
And if an affirmation of these underlying decisions occur, then it renders this federal court's decisions in a number of matter of cases, including Knudsen, Scheife, Walther, and of course, Alfven, if we're talking about the Alfven prongs, because I have yet to see where petitioners have been able to meet their burden of prong one by using statistics.

[00:23:46] Speaker 01:
Because as this court has noted,

[00:23:48] Speaker 01:
The infections will almost always outweigh or have more statistical chances of causing GBS.

[00:24:02] Speaker 01:
And in this case, too, it's not just an underlying infection that a respondent has argued and that the chief special master found as causing the GBS.

[00:24:15] Speaker 01:
It was specifically said the H

[00:24:17] Speaker 01:
influenza was the sole substantial cause.

[00:24:22] Speaker 01:
And if we affirm this decision, it also would render petitioners at large, any time they have a concurrent infection, it would render them unable to participate in the vaccine program because their statistics, as rejected by this court, will always have usually

[00:24:45] Speaker 01:
higher statistics in causing GPS.

[00:24:48] Speaker 01:
And that's not anything that this court has ever agreed upon.

[00:24:53] Speaker 02:
Council, as you can see, your red light has been on for a while.

[00:24:57] Speaker 02:
Oh, sorry.

[00:24:58] Speaker 02:
Thank you.

[00:24:58] Speaker 02:
Appreciate both arguments, and the case is submitted.

[00:25:00] Speaker 01:
Thank you, sirs.