[00:00:00] Speaker 01:
We're now 23-2404 Doles versus HHS.

[00:00:05] Speaker 01:
Mrs. Maglio.

[00:00:08] Speaker 03:
May I please support?

[00:00:11] Speaker 03:
My firm, MCT Law, represents the appellant, Ms.

[00:00:14] Speaker 03:
Elizabeth Doles.

[00:00:16] Speaker 03:
Ms.

[00:00:16] Speaker 03:
Doles suffered a vaccine injury when her vaccinations triggered her pre-existing but clinically silent MS, causing it to become overt.

[00:00:26] Speaker 03:
And at that stage, she experienced active MS symptoms.

[00:00:30] Speaker 01:
Could I see if we're on the same page?

[00:00:32] Speaker 01:
As I read the government brief, they agree that you're right about the Langer-Gruhl study in the sense that it does say something about manifestations about MS.

[00:00:48] Speaker 01:
And if I understand, I'll ask them about this, but as I understand it, they're saying, well, the judge was right with respect to the Langer-Gruhl study for only two reasons.

[00:00:58] Speaker 01:
One,

[00:00:59] Speaker 01:
the study didn't cover older people such as your client, and second, that the injury wasn't manifested within the 30-day period covered by the Langer Goal study.

[00:01:13] Speaker 01:
But otherwise, if I understand them correctly, they agree that the study is relevant, say, for those two qualifications.

[00:01:22] Speaker 01:
Is that the way you understand what they're saying?

[00:01:26] Speaker 03:
Yes, I believe so, your honor.

[00:01:28] Speaker 03:
And what the Langergold study did make that finding as a statistically significant finding in terms of the age of the study group that they found statistically a relationship that was statistically significant and the timing of the symptoms after the receipt of vaccination.

[00:01:47] Speaker 03:
However, this court has stated and drew in other cases that that finding of statistical significance is not

[00:01:55] Speaker 03:
what binds special masters to a consideration of whether a study supports proof of causation.

[00:02:01] Speaker 01:
Did your expert, Dr. Steele, say that nonetheless he found the study to be relevant?

[00:02:08] Speaker 03:
Yes.

[00:02:09] Speaker 03:
Dr. Steele relied on the study, and he relied explicitly on the study's conclusions, which went beyond their statistically significant findings.

[00:02:16] Speaker 02:
Could we just back up for a second and get framed out what you're often long-loving for theories?

[00:02:25] Speaker 03:
Yes.

[00:02:27] Speaker 02:
I know that Langer-Duhl is involved, but there was also talk about the T-cell theory.

[00:02:31] Speaker 02:
So can you just tell us what you believe Steele's often-loving-for theory was about why this shot aggravated the condition?

[00:02:46] Speaker 02:
Right.

[00:02:46] Speaker 02:
Causation of aggravation.

[00:02:48] Speaker 03:
And so I don't believe that, or Dr. Seale discussed mechanism to some extent, but what he, his theory was under living, um, prong for was that it was a, and it was a sound and reliable theory was that, uh, vaccination could trigger the onset of active symptoms, clinical symptoms.

[00:03:09] Speaker 03:
This could, Dr. Steele speculated or suggested that it could be, as did the Langer-Gould study, that it could be through T cell activation, bystander activation, molecular mimicry.

[00:03:21] Speaker 03:
And Langer-Gould especially looked at all of those different things and said that akin to an infection, a vaccination could trigger

[00:03:32] Speaker 03:
the onset of symptoms in a period of time after the receipt of the vaccination.

[00:03:36] Speaker 02:
And the kin to the infection is because of the T cell and the theory of the molecular mimicry, correct?

[00:03:43] Speaker 03:
That is correct, Your Honor.

[00:03:44] Speaker 03:
And if you'd like me to, I can look at Langer World specifically on that.

[00:03:47] Speaker 02:
No, no.

[00:03:48] Speaker 02:
I'm trying to focus away from Langer because the way in which the case was taken around by the first time by the Court of Federal Claims is if it all relied on Langer.

[00:03:58] Speaker 02:
and then faulting Langer for the various reasons.

[00:04:02] Speaker 02:
But it looked to me as if when you read the way the decision is put together, Langer follows after the discussion of molecular mimicry.

[00:04:11] Speaker 02:
And that sort of thing.

[00:04:12] Speaker 02:
So if you're looking at the first decision by the special master is his analysis of prong four, right?

[00:04:25] Speaker 03:
Yes, sir.

[00:04:25] Speaker 02:
Because he has a specific section on prong four.

[00:04:29] Speaker 02:
If you look at the bottom of page 141, he's talking about various theory, and he comes over and says, in that context.

[00:04:38] Speaker 02:
So if you turn to page 142, Langer-Gould is arising in the context of a previous explanation.

[00:04:47] Speaker 02:
Correct, Your Honor.

[00:04:49] Speaker 02:
So is it your view that Langer-Gould isn't necessarily the only reason for the theory?

[00:04:57] Speaker 03:
Yes, Your Honor, and that is also evidenced by the second decision of the special master where he reviewed the evidence in accordance with the remand instructions and he excluded Langer Gould from the consideration and he talked about Dr. Steele's expert report.

[00:05:14] Speaker 03:
He talked about Dr. Sriram's discussion of MS and how... Didn't Dr. Steele's opinion

[00:05:19] Speaker 00:
make it seem like your client experienced a post-vaccine attack separate from the underlying MS?

[00:05:28] Speaker 00:
I mean, that was my confusion about reliance on Dr. Steele.

[00:05:32] Speaker 03:
Dr. Steele and certainly the special master noted Dr. Steele's opinion

[00:05:39] Speaker 03:
included aspects that talked about TM or APTM as a separate event.

[00:05:43] Speaker 03:
He also talked about it being in the context or related to the MS.

[00:05:48] Speaker 03:
So there was, as the special master said, some tension in Dr. Steele's expert report.

[00:05:53] Speaker 03:
And the special master noted that and then looked at the additional case studies and the additional research that was presented and found that Dr. Steele had been talking about

[00:06:09] Speaker 03:
the APTM or the TM, that separate event, that acute event, in the context of the overall chronic disorder, which was the ongoing MS, which had been subclinical, no symptoms experienced, but radiological findings found that there had been the beginning of lesions in the brain, and then the vaccinations as triggering that onset of active symptoms.

[00:06:36] Speaker 03:
and the acute event.

[00:06:38] Speaker 02:
So, yes, Dr. Steele talked about it as a discrete event, but he also talked about it in the context of MS, and he talked about how APTM is strongly associated with... Part of the confusion initially as to whether this case was going to go off on actual cause or whether it was going to go off on aggravation and looking at the events, correct?

[00:07:01] Speaker 03:
That is correct, Your Honor.

[00:07:03] Speaker 02:
I mean, at this stage in the game, we have an often one-leaving-four case, isn't that correct?

[00:07:10] Speaker 02:
The only thing that's questioned.

[00:07:11] Speaker 02:
Right.

[00:07:12] Speaker 02:
And you are directly attacking the court of claim's first decision that upset Special Master Horner's first decision, correct?

[00:07:21] Speaker 02:
That is correct.

[00:07:22] Speaker 02:
If we were to decide that you're correct,

[00:07:24] Speaker 02:
and that the first special master decision was not arbitrary and capricious on the prom 1-4, then you don't have to prove anything else, correct?

[00:07:35] Speaker 03:
That is correct, because Special Master Horner found the other prongs were met.

[00:07:40] Speaker 00:
But wait a minute, wasn't one of the bases upon which the special master, the court of federal claims, relied in reversing the first decision that the

[00:07:51] Speaker 00:
The special master herself or himself came up with this aggravation theory, and it's one that the government never even had a chance to respond to.

[00:07:59] Speaker 00:
So wasn't there an independent, even if we disagree with the line of goal setting, there was an independent basis for which the court of federal claims could have correctly vacated that opinion, right?

[00:08:10] Speaker 03:
And that is correct, and that was argued before the Court of Federal Acclaims, and there was points in the record that pointed to significant aggravation.

[00:08:20] Speaker 03:
It was a pled cause of action, and it was also

[00:08:25] Speaker 03:
referred to both by the prior special master, the special master prior to special master Horne, and even in, as special master Horner pointed out in, at appendix, I believe it's page 70, in his second decision, that it had been referred to in the initial briefing by the respondent.

[00:08:44] Speaker 03:
But in addition to that, your honor, I would suggest that when the court of federal claims remanded the case,

[00:08:51] Speaker 03:
Based on the two points, you're right, the fundamental fairness issue of whether significant aggravation had been significantly brought up between the parties.

[00:09:02] Speaker 03:
and whether the respondent had had enough opportunity to brief it, and the second point on the Langer-Gould study, that that problem, what he, the remand instructions were to... Been cured.

[00:09:15] Speaker 03:
Exactly.

[00:09:15] Speaker 02:
It's been cured.

[00:09:16] Speaker 02:
I'll say it hasn't had an opportunity to... Right.

[00:09:19] Speaker 00:
Can I ask you kind of just a legal question on what your briefing, the case law, you rely on case law in your briefing supporting affirming fact-finding

[00:09:30] Speaker 00:
as long as the evidence on which it is based is not wholly implausible.

[00:09:37] Speaker 00:
Correct.

[00:09:38] Speaker 00:
But we've also said that a plausible medical theory is not sufficient.

[00:09:43] Speaker 00:
It needs to be probable.

[00:09:45] Speaker 00:
So how do you reconcile those two?

[00:09:48] Speaker 03:
Because at this point, we're talking about the plausibility of the evidence and also whether the other arbitrary and capricious standard cases also talk about

[00:09:57] Speaker 03:
the special master considering all of the relevant record evidence, not drawing implausible record.

[00:10:06] Speaker 01:
I think there are two different issues here.

[00:10:10] Speaker 01:
One is the standard of review of the special master, which is I think established that its plausibility is the standard of review.

[00:10:20] Speaker 01:
I'm not sure that's right, but our case law establishes that, I think.

[00:10:23] Speaker 01:
But I don't think our case law establishes

[00:10:25] Speaker 01:
that the special master has to rule in favor of the claimant if the claimant presents plausible evidence.

[00:10:32] Speaker 01:
I think those are two different things.

[00:10:34] Speaker 03:
And in this case, the standard of review does look to whether the special master made any implausible inferences.

[00:10:43] Speaker 03:
and the Langer-Gould study, the special master took the conclusions from the study verbatim.

[00:10:49] Speaker 03:
Both special masters did.

[00:10:50] Speaker 01:
Could we talk for a minute about the third special master decision, the special master Ullers decision, which you also rely on.

[00:10:57] Speaker 01:
And she said that she would have found in your favor on pronged four of loving.

[00:11:02] Speaker 01:
if she'd been allowed to consider the linear goal study.

[00:11:06] Speaker 01:
As to prong five of loving, though, she doesn't seem to reach that.

[00:11:11] Speaker 01:
Is it your view that if her finding as to prong four is sustained that she would necessarily have to find under prong five in your favor?

[00:11:24] Speaker 03:
uh... she would need to find out her problem five but i would suggest that her discussion is that she found there was second uh... that from six evidence was highly probative on from five she found there was a highly probative evidence supporting from five but at the end of the day she concluded she could not establish from five or rule in favor of petition on from five simply because of the prom for

[00:11:53] Speaker 03:
analysis because she could not consider Langer Gould.

[00:11:56] Speaker 03:
So she suggests at Appendix 44 that there was highly provative evidence on Prong 5 and that she would find that way.

[00:12:05] Speaker 03:
And she also suggests in her footnote that she was setting forth her analysis to avoid the need for remand.

[00:12:15] Speaker 03:
So her suggestion is that

[00:12:19] Speaker 03:
this should be considered a full and complete opinion that doesn't need to be remanded for further review if she had been permitted to consider Langer-Gould.

[00:12:33] Speaker 02:
Can I ask a question about the Langer-Gould study in particular?

[00:12:36] Speaker 02:
Yes.

[00:12:38] Speaker 02:
I was looking at, this is on Troy Dependix 2206,

[00:12:46] Speaker 02:
dealing with the analysis of the MS patients in particular in figure 2 to B. It looks to me like there's at least one patient in Ms.

[00:13:01] Speaker 02:
Dole's age group that had the first manifestation in the time period, 42 days.

[00:13:08] Speaker 03:
Yes, Your Honor.

[00:13:09] Speaker 02:
It looked to me like there was one person in that matter.

[00:13:12] Speaker 02:
Not very many elderly people were examined in that study, but there's at least one that was right on her case.

[00:13:19] Speaker 03:
That's correct, Your Honor.

[00:13:20] Speaker 03:
And that makes the circumstantial proof evidence tending to prove that there could be an association.

[00:13:27] Speaker 02:
And what the study authors conclude is that... If you went out to 90 days beyond her 42, there are four more.

[00:13:37] Speaker 03:
Yes, Your Honor.

[00:13:38] Speaker 03:
And what the study authors were in their conclusions, what they were stating is that their study findings didn't suggest that the vaccinations would trigger the

[00:13:49] Speaker 03:
a person becoming or experiencing symptoms of MS wouldn't trigger MS as a disorder entirely, but it would trigger the onset of symptoms in a person who already had a subtitle.

[00:14:04] Speaker 02:
They were looking to see whether or not they could establish a connection between the vaccines and causation of MS.

[00:14:11] Speaker 02:
They said that was the purpose.

[00:14:13] Speaker 02:
But they were unable to do that.

[00:14:15] Speaker 02:
And they said, of course, we haven't been able to prove that.

[00:14:17] Speaker 02:
But the NSN said, gee whiz, look what we did find.

[00:14:21] Speaker 02:
We did find that if you are administering a range of these vaccines to people, you're going to trigger MS symptoms in various time periods.

[00:14:32] Speaker 03:
That is correct.

[00:14:33] Speaker 03:
That is correct.

[00:14:34] Speaker 02:
And they surmised that that possibly could show that there was an exacerbation or an aggravation of an underlying condition.

[00:14:42] Speaker 03:
Right, a triggering of the symptoms.

[00:14:44] Speaker 03:
And they also found on Appendix 2307, they stated, our findings are consistent with vaccines acting as a pro-inflammatory cofactor in individuals with subclinical autoimmunity.

[00:14:58] Speaker 03:
Because this mechanism, and again, they refer back to the T cells, would be expected to hasten symptom onset, but not change the long-term risk of developing MS or CIS.

[00:15:10] Speaker 03:
And so that's exactly it.

[00:15:12] Speaker 03:
Their conclusions are they're finding they're consistent with the case reports that anecdotally have stated that after receipt of vaccination, there can be an onset of symptoms.

[00:15:21] Speaker 03:
And they're stating that it is consistent with vaccines acting in the same way that infections have been found to act as being a factor that could trigger the onset of symptoms.

[00:15:38] Speaker 01:
Okay, I think we're out of time, so we'll give you two minutes for rebuttal.

[00:15:42] Speaker 03:
Thank you, Your Honor.

[00:15:43] Speaker 01:
Ms.

[00:15:43] Speaker 01:
Stuller.

[00:16:03] Speaker 04:
Good afternoon.

[00:16:04] Speaker 04:
May it please the Court

[00:16:06] Speaker 01:
while review of the factual findings made by... Is the statement I made earlier about your position accurate that you now agree that the only reasons for setting aside the Langer-Gool study are one, the age aspect of it, and two, the number of days for manifestation of symptoms?

[00:16:34] Speaker 04:
Yes, because Petitioner does not fall within the groups where they found it increased in risk.

[00:16:40] Speaker 01:
OK, and so to the extent that the Special Master relied on other aspects of Langer-Gould, he was wrong about that.

[00:16:49] Speaker 04:
I'm sorry, can you repeat the question?

[00:16:51] Speaker 01:
To the extent that the Court of Federal Claims judge ruled out Langer-Gould for other reasons, he was mistaken, right?

[00:17:00] Speaker 04:
Um, I'm not quite sure what other reasons you're referring to.

[00:17:03] Speaker 01:
Well, he seemed to think that it didn't show anything about MS or MS manifestation.

[00:17:10] Speaker 01:
And I, I think he was wrong about that.

[00:17:12] Speaker 01:
And I, as I read your brief, you agree that he was wrong about that aspect of it.

[00:17:18] Speaker 04:
Um, well, we say that there's no association between vaccines and MS onset that Langer Gold found.

[00:17:25] Speaker 04:
And so I think the CFC was correct.

[00:17:28] Speaker 04:
in finding that was the conclusion of the study.

[00:17:32] Speaker 01:
Well, wait.

[00:17:32] Speaker 01:
Now I'm confused.

[00:17:34] Speaker 01:
Because I thought you just agreed with me that the only basis for setting aside the study were the age limitation and the days limitation.

[00:17:44] Speaker 04:
Yes, those are the two main reasons.

[00:17:46] Speaker 01:
But he went beyond that.

[00:17:48] Speaker 01:
He said Langer-Gould doesn't tell us anything about manifestation of MS.

[00:17:54] Speaker 01:
And that's wrong, right?

[00:17:56] Speaker 04:
No, I agree with the Court of Federal Claims that the Langer Gold study doesn't tell us anything about the manifestation of MS because the conclusions... Even for the 30-day time period and for the age group?

[00:18:09] Speaker 04:
Right, because that finding was limited to all central nervous system acquired to myelinating syndromes.

[00:18:16] Speaker 01:
Which includes MS.

[00:18:17] Speaker 04:
It includes MS, but it's not specific.

[00:18:19] Speaker 04:
It's not a finding that's specific to MS.

[00:18:21] Speaker 01:
But to the extent that he seemed to rule out the study on the ground that had nothing to do with MS, he's wrong about that.

[00:18:28] Speaker 01:
Because the study considers a group of conditions, including MS, whose manifestation can be triggered by vaccines for the right age group for the right time period, right?

[00:18:44] Speaker 04:
Sure.

[00:18:44] Speaker 04:
And I understand what you're saying.

[00:18:45] Speaker 04:
Yes.

[00:18:46] Speaker 01:
Yeah.

[00:18:47] Speaker 01:
OK.

[00:18:48] Speaker 01:
And so with respect to the Oehler study, do you agree that if we say that he was wrong about the Langer-Gould study that we should affirm, that we should hold that the causation was established under the findings made by Special Master Oehler?

[00:19:10] Speaker 04:
If you allow Special Master Oehler to rely upon the Langer Gold study in the way that she proposed, I agree that the government would not prevail in this case.

[00:19:19] Speaker 00:
So it's not an affirm, it's a reverse?

[00:19:22] Speaker 04:
It would be, yeah, it would be a reversal of her findings because she just... No, it would be a reversal of the Court of Federal Claims.

[00:19:30] Speaker 02:
Yes.

[00:19:31] Speaker 02:
But that isn't the result the same if we just agree, if we found that the first decision by the Court of Federal Claims was wrong.

[00:19:38] Speaker 02:
on the theory issue.

[00:19:42] Speaker 02:
I mean, Judge Dyke was the presiding judge referring to the older opinion.

[00:19:47] Speaker 02:
And older comes in later on.

[00:19:49] Speaker 02:
But I mean, the first decision by the first special master found all elements of a loving claim shown.

[00:19:57] Speaker 02:
Right.

[00:19:57] Speaker 02:
Right.

[00:19:58] Speaker 02:
And the only missing element would be, you know, one four.

[00:20:03] Speaker 02:
Right.

[00:20:04] Speaker 02:
It looked to me as if the way that your adversary was presenting the case first was to say, decide first whether the court of federal claims was right in the very first instance.

[00:20:16] Speaker 02:
Because if they were not right in the first instance, then all the rest of the cases mooted out.

[00:20:20] Speaker 02:
There wasn't any need for a remand, et cetera, correct?

[00:20:24] Speaker 04:
I mean, I think that that's correct, except there was a conversation earlier about the fact that within the first, for the first go-round, the government had not had an opportunity.

[00:20:36] Speaker 00:
Yes, I understand, but that clearly... What's before us?

[00:20:39] Speaker 00:
What do we have?

[00:20:40] Speaker 00:
I don't know, we're using the word jurisdiction, but what's before us?

[00:20:44] Speaker 00:
Is it just this last court of federal claims opinion?

[00:20:50] Speaker 04:
No, I think it's all of it.

[00:20:52] Speaker 04:
I mean, we have...

[00:20:53] Speaker 04:
The initial entitlement ruling, we have the ruling on remand that Special Master Horner gave.

[00:21:00] Speaker 02:
We then have Special Master... She never had a chance to appeal any of the previous decisions by the court of federal claims because they weren't final.

[00:21:10] Speaker 02:
That's correct.

[00:21:11] Speaker 02:
So she starts, as I believe correct, we just say, let's start at the very front of the case and say, was the first action by the court of federal claims correct?

[00:21:20] Speaker 02:
Because if it was wrong,

[00:21:22] Speaker 02:
The special master had found all the elements of the claim, of the loving claim, met.

[00:21:28] Speaker 02:
And the only claim that was being challenged has not met was the theory, right?

[00:21:33] Speaker 02:
Right.

[00:21:34] Speaker 02:
And if we reverse and say the theory was correct, you don't need to go on past the very first decision by the Court of Federal Claims.

[00:21:42] Speaker 04:
Yes, I believe that's correct.

[00:21:45] Speaker 02:
I mean, you would get out of it the same way if you were relying on Alder's findings later on, I think.

[00:21:51] Speaker 02:
But you don't need the notion that the government was prejudiced by not knowing that this was going to be an inauguration case.

[00:21:59] Speaker 02:
You're not arguing that that claim has any legs at this stage in the game.

[00:22:03] Speaker 02:
That's correct, because we had an opportunity to play that.

[00:22:06] Speaker 02:
And the record was closed.

[00:22:07] Speaker 02:
The record never reopened from the first special master's decision.

[00:22:12] Speaker 04:
Actually, the record was opened on first remand.

[00:22:16] Speaker 02:
But it was opened not on the Alton IV issue.

[00:22:20] Speaker 04:
No, it was.

[00:22:21] Speaker 02:
In what respect?

[00:22:25] Speaker 04:
Judge Schwartz said that the parties could offer additional evidence on the significant aggravation theory on remand.

[00:22:32] Speaker 02:
And what was offered?

[00:22:34] Speaker 04:
The parties didn't offer any additional evidence.

[00:22:36] Speaker 02:
That's what I mean.

[00:22:37] Speaker 02:
So the record was closed.

[00:22:39] Speaker 04:
After they, yes, declined to offer.

[00:22:42] Speaker 02:
I'm saying the record on the question of whether or not the theory prong was satisfied was that all the evidence in the record was in the first go-around in front of Judge Horn.

[00:22:55] Speaker 02:
Right, that's correct.

[00:22:56] Speaker 02:
Yes, they were invited to submit, but none was submitted.

[00:22:59] Speaker 02:
Correct.

[00:23:00] Speaker 02:
I mean, it just seems to me that the government, the argument that the government was denied due process, if that was true by the first decision, that issue just totally mooted out.

[00:23:09] Speaker 02:
It doesn't exist anymore.

[00:23:11] Speaker 02:
That's correct.

[00:23:12] Speaker 02:
Thank you.

[00:23:17] Speaker 02:
So what's wrong with the T cell theory?

[00:23:22] Speaker 02:
I mean, we've seen that expressed in other cases where they say this molecular mimicry, basically what happens is T cell activity is shown to attack the myelin protective cell around the nerves.

[00:23:39] Speaker 02:
This can activate activity.

[00:23:41] Speaker 02:
And lo and behold, you see in the Langer-Gill study that there are lots and lots of manifestations of various demyelinating diseases within relative timeframes from the administration of the vaccines.

[00:23:56] Speaker 02:
Well, I think what... And Langer-Gould is relying on that theory itself, clearly in it, talking about molecular activity, C cell activity, and then making a general finding that it is possible that this is an aggravating event.

[00:24:14] Speaker 04:
Well, I think what's wrong is that the conclusions that Langer Gold reached were limited to that specific population.

[00:24:21] Speaker 04:
So it was only patients who were younger than 50 years old.

[00:24:26] Speaker 04:
Petitioner was 67.

[00:24:27] Speaker 04:
And only patients who had onset within 30 days of vaccination.

[00:24:32] Speaker 04:
Petitioner, in this case, had more than four days.

[00:24:34] Speaker 02:
It was only happening often enough to allow them to make a prediction.

[00:24:37] Speaker 04:
Yeah, there was no statistically significant finding in this study that's relevant to Petitioner.

[00:24:42] Speaker 04:
And I think Judge Schwartz was correct to say that without any association, you cannot have this study support a causal theory.

[00:24:51] Speaker 01:
I have problems with that, because it seems to me that, first of all, as the record shows, that it would be hard to design a study

[00:25:02] Speaker 01:
for 67-year-old people just because MS doesn't appear very often with respect to the 67-year-old people.

[00:25:11] Speaker 01:
And then, you know, the fact that manifestation is 14 days after the 30-day period seems to me to be relevant but not dispositive in terms of excluding the study.

[00:25:26] Speaker 01:
Studies all the time have to be extrapolated and I think, didn't Dr. Steele say why this study was relevant and isn't the study circumstantial evidence to support the petitioner's position?

[00:25:42] Speaker 04:
No, I don't think that the study is circumstantial evidence.

[00:25:46] Speaker 04:
Dr. Steele talked about the study only with respect to TM, so only with respect to transverse myelitis and whether or not you could see an increase in transverse myelitis, not MS.

[00:25:58] Speaker 04:
And he also said that there wasn't sufficient evidence to support

[00:26:03] Speaker 04:
the conclusions that the Langer Gold authors reached with regard to the idea that vaccines could somehow take underlying autoimmunity and render it overt.

[00:26:15] Speaker 02:
You don't see Langer Gold as being possibly substantial evidence of what I refer to as the T cell theory.

[00:26:25] Speaker 04:
No, I do not see Langer-Gould to be particularly relevant at all in this case, given petitioner circumstances.

[00:26:32] Speaker 02:
But the first time around, Judge Special Master Horner, as I pointed out, was discussing first the molecular structure theory.

[00:26:43] Speaker 02:
And then he says, in this context, I'm looking at Langer-Gould.

[00:26:49] Speaker 04:
Yeah.

[00:26:51] Speaker 02:
He doesn't start off by saying Langer Gould proves all this.

[00:26:56] Speaker 02:
He has a theory that he says in that context

[00:27:00] Speaker 02:
Look at Langer-Gould.

[00:27:01] Speaker 04:
But Langer-Gould doesn't serve as evidence for Petitioner's theory, because Petitioner was 67 and had onset more than 40 days after vaccination.

[00:27:11] Speaker 04:
And Petitioner could have gone out.

[00:27:14] Speaker 02:
The question is whether Langer-Gould serves to teach any information.

[00:27:19] Speaker 02:
Is it valuable for any purpose in teaching any information about the subject of the issue?

[00:27:25] Speaker 04:
I mean, I don't think so.

[00:27:27] Speaker 04:
I think that the study needs to be relevant to Petitioner.

[00:27:30] Speaker 00:
Can I add, you may not know this, but on the table, do they include the population that was covered in the time frame that was covered by Langer-Gould?

[00:27:41] Speaker 00:
Is that considered an on-table case?

[00:27:44] Speaker 04:
I'm sorry, you're talking about the vaccine injury table?

[00:27:46] Speaker 00:
Yeah, yes.

[00:27:48] Speaker 04:
And can you repeat your question?

[00:27:50] Speaker 00:
If the population for Langer-Gould and the age population and the time, is that a table injury?

[00:27:58] Speaker 04:
No, that's not a table injury.

[00:27:59] Speaker 04:
This is all off table.

[00:28:02] Speaker 04:
So the table has injuries that are specific to the vaccination.

[00:28:11] Speaker 04:
I'm not thinking

[00:28:15] Speaker 04:
I'm not aware of any age limitations that the table puts on recovery for certain injuries.

[00:28:24] Speaker 04:
I mean, I think you can say things like the rotavirus vaccine are traditionally given to children.

[00:28:30] Speaker 04:
And so it would be extremely unusual to have an adult

[00:28:34] Speaker 04:
table for rotavirus interception.

[00:28:37] Speaker 00:
And this is just a random question because I've been doing these cases and I should know the answer to this.

[00:28:41] Speaker 00:
But do table injuries include aggravation too?

[00:28:45] Speaker 00:
Separate things for aggravation as opposed to causation?

[00:28:50] Speaker 04:
Yes, you can have on table a significant aggravation case.

[00:28:54] Speaker 04:
Thank you.

[00:28:55] Speaker 01:
So the government's view of what's evidence in these vaccine cases seems to me to be awfully cranked.

[00:29:03] Speaker 01:
that if you have evidence that a 50-year-old can develop MS symptoms as a result of a vaccination, why can't you say that that's some evidence that a 67-year-old would have the same result?

[00:29:21] Speaker 01:
It doesn't seem to me that the Leonard Rule study somehow suggests that there's something unique about young adults.

[00:29:29] Speaker 01:
And to extrapolate from that and say, well, if it affected a 50-year-old or probably also affected a 67-year-old, that seems to me within the realm of relevant evidence.

[00:29:40] Speaker 01:
And for you to say that because the study didn't specifically deal with 67-year-olds that it's irrelevant seems to me probably not correct.

[00:29:49] Speaker 04:
Well, the reason why Langer Gold bifurcated its study population into 15, or excuse me, younger than 50 and 15 and above is because they were specifically interested in how age affected the onset.

[00:30:04] Speaker 04:
And they were looking at age as a factor.

[00:30:06] Speaker 01:
The Langer Gold study doesn't suggest that a 50-year-old is more likely to develop symptoms than a 67-year-old, right?

[00:30:17] Speaker 04:
Well, they only found an increased risk in the population that was less than 50.

[00:30:22] Speaker 01:
Well, they didn't have very many 67-year-olds.

[00:30:25] Speaker 04:
Well, Petitioner could have offered another study if they had a desire that addressed a study population that was more relevant to her age.

[00:30:34] Speaker 01:
It doesn't seem to me that's the way medicine works.

[00:30:36] Speaker 01:
If you have a study that shows there's a strong likelihood that a 50-year-old would develop symptoms, if you were a physician, you'd worry about a 67-year-old also, wouldn't you?

[00:30:46] Speaker 04:
But it doesn't change the fact that this study didn't make any findings regarding 67-year-olds that were statistically significant.

[00:30:56] Speaker 02:
Although there were actual somebody very much like Ms.

[00:31:01] Speaker 02:
Doles in the study, right, that had the vaccine and had the effect within the 14-day period.

[00:31:09] Speaker 04:
But I don't believe that that individual was in the age group.

[00:31:12] Speaker 02:
I'm just saying, as a matter of just counting people that had the symptoms, there is a 42-day example in the MS where there were at least one person had the adverse symptom.

[00:31:29] Speaker 04:
I mean, it's true that, yes, there was one person who

[00:31:33] Speaker 02:
And then if you go from 42 days to 90 days, which is just not a great leap, you find another four.

[00:31:43] Speaker 02:
Over 50.

[00:31:44] Speaker 04:
I mean, but these were not statistically significant findings.

[00:31:47] Speaker 04:
Those are just data points.

[00:31:48] Speaker 02:
Well, they weren't findings that were sufficient to allow you to make an odds guess, right?

[00:31:55] Speaker 02:
But I'm just saying they are people who were studied in the case, and they read right on tolls.

[00:32:11] Speaker 01:
Thank you.

[00:32:26] Speaker 03:
Langer Gould provides supportive evidence under this Court's

[00:32:30] Speaker 03:
precedent regarding circumstantial evidence and what is supportive of causation.

[00:32:35] Speaker 03:
And in cases such as Alton and Andrew, the circuit has discussed how circumstantial evidence can be provided to prove causation and has gone on to state that the preponderance standards only requires legal probability, not medical or scientific certainty.

[00:32:56] Speaker 03:
And in Andrew, the court talked about how

[00:33:00] Speaker 03:
scientific certainty is very near certainty, whereas preponderance is more likely than not.

[00:33:06] Speaker 03:
And in discussing the type of evidence that can support causation, Andrew stated that medical literature cannot be viewed through the lens of the laboratorian, but can't be viewed as requiring scientific certainty.

[00:33:22] Speaker 03:
It has to be viewed as allowing for the notion of circumstantial evidence, the notion of preponderance evidence.

[00:33:31] Speaker 03:
And here, the Langer-Gould study made several findings that would apply as preponderant evidence, supportive of causation in this case, that would apply to the petitioner here.

[00:33:49] Speaker 03:
And they found that

[00:33:52] Speaker 03:
In their conclusions, they found that vaccines like infections may accelerate the transition from subclinical to overt autoimmunity in patients with existing disease.

[00:34:03] Speaker 03:
And that is akin to what Dr. Steele said.

[00:34:05] Speaker 03:
He said that there was a chance that this onset of symptoms, this acute symptom, the TM, would occur in the context of the underlying MS.

[00:34:15] Speaker 03:
And Langer-Gould also stated that their conclusions supported clinical anecdotes that

[00:34:22] Speaker 03:
central nervous system demyelinating disorders could have symptom onset shortly after vaccination.

[00:34:30] Speaker 03:
All of this goes to causation and it goes to show that petitioner's case was supported on Loving Prong 4.

[00:34:36] Speaker 01:
I think we're out of time.

[00:34:38] Speaker 03:
Thank you.

[00:34:39] Speaker 01:
Thank you.

[00:34:39] Speaker 01:
Thank both counsels for this.