[00:00:00] Speaker 01:
Our next case is Tasha Lloyd versus the secretary of HHS, 2022-1371.

[00:00:09] Speaker 01:
Good morning, Mr. Gage.

[00:00:12] Speaker 01:
May it please the court.

[00:00:19] Speaker 02:
The issue today is whether or not this court's long-held decision in Alton, precedent in Alton, prong one,

[00:00:29] Speaker 02:
is still the law, or whether the majority decision in Boatman overturned Alphenprong I?

[00:00:35] Speaker 01:
Well, one of the Alphenprongs is temporal relationship.

[00:00:40] Speaker 01:
Yes.

[00:00:41] Speaker 01:
And that's a question of fact.

[00:00:43] Speaker 01:
And we give deference to the special master on questions of fact.

[00:00:49] Speaker 01:
And so there was a nine-month passage of time between

[00:00:56] Speaker 01:
the vaccination and the onset of symptoms.

[00:01:03] Speaker 01:
So why don't you lose?

[00:01:07] Speaker 02:
That goes to my second issue on appeal.

[00:01:11] Speaker 02:
The question is whether on that is the fact question of whether or not there were symptoms of ITP in September of 2013.

[00:01:22] Speaker 02:
and I'd like to keep my argument in order if I can, but just a preview, I guess, of that is that the special master did not consider our evidence on that issue.

[00:01:34] Speaker 02:
If he's forced to consider our evidence on the symptoms in 2013, September 2013, that that's his basis for saying it took nine months.

[00:01:48] Speaker 02:
If he considers our symptoms,

[00:01:50] Speaker 02:
we put on clear evidence that, in fact, the symptoms started within weeks of the vaccination.

[00:01:56] Speaker 02:
So, alpha and prong three is tied up absolutely with alpha and prong two.

[00:02:02] Speaker 02:
And alpha and prong two is one of our appeal issues.

[00:02:05] Speaker 02:
So, we have to, that issue of alpha and prong two has to be determined whether and how it is decided also decides alpha and prong three.

[00:02:15] Speaker 02:
Alpha and prong three just goes along with alpha and prong two.

[00:02:19] Speaker 02:
I'd like to start with reading what the Boatman decision said in relation to Alpenprong 1.

[00:02:32] Speaker 02:
A petitioner must provide a reputable medical or scientific explanation for its theory.

[00:02:38] Speaker 02:
Well, it does not require medical or scientific certainty.

[00:02:41] Speaker 02:
It must still be sound and reliable.

[00:02:44] Speaker 02:
They cite Knutson for that point.

[00:02:46] Speaker 02:
When the Boatman panel is criticizing the special master here, they're criticizing the special master's alpha and prong one analysis, can the vaccine cause the injury?

[00:02:58] Speaker 02:
So they're citing Knutson for that proposition.

[00:03:01] Speaker 02:
And going back to Knutson, where they're citing it,

[00:03:05] Speaker 02:
Proof of a logical sequence of cause and effect that the vaccination was the reason for the injury and their site J It's citing grant and then this logical sequence of cause and effect must be supported by sound inter liable medical or scientific explanation that comes from Dow bear so what the

[00:03:26] Speaker 02:
Boatman majority did is they cited the language from Knudsen that is the direct language that makes up Altenprong 2, and they applied it to their analysis of Altenprong 1.

[00:03:43] Speaker 02:
And in doing that, they incorporated the quote from Daubert, sound and reliable, and incorporated that into the Altenprong 1 analysis.

[00:03:55] Speaker 02:
So the question here is, does Altham-Prong 1 plausible medical theory still apply?

[00:04:06] Speaker 02:
Or did Boatman, by quoting Knudsen, overturn Altham-Prong 1's plausible medical theory standard and make it the sound and reliable standard?

[00:04:21] Speaker 02:
And that is how this particular special master interpreted it, and that's how it is being interpreted.

[00:04:28] Speaker 02:
Alfven is our, the vaccine program's, super precedent.

[00:04:36] Speaker 02:
It is the case we always come back to.

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It gets cited by everybody at every level.

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It's the one that sets forth the standards for causation cases.

[00:04:47] Speaker 02:
The reason that Alfven was decided was a previous special master decided a case called Stevens.

[00:04:53] Speaker 02:
It was Gary Galkowitz, the original chief special master.

[00:04:57] Speaker 02:
In Stevens, he said, in order for petitioners to prevail in causation cases, they have to produce medical literature and show that their theory, so the can cause general theory, is generally accepted in the medical community.

[00:05:14] Speaker 02:
This court in Alton said, no, you can't add those requirements on.

[00:05:20] Speaker 02:
Those requirements for a causation case would destroy, in essence, petitioners' ability to bring causation cases.

[00:05:29] Speaker 02:
The reason for that is because if everybody agrees, everybody knows

[00:05:34] Speaker 02:
This vaccine causes this injury.

[00:05:38] Speaker 02:
Those are the cases that populate the vaccine injury table.

[00:05:41] Speaker 02:
Those are the ones that everybody accepts.

[00:05:43] Speaker 02:
We all know that.

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There's nothing to argue about.

[00:05:46] Speaker 02:
The cases that are causation cases by their very nature, the medical science hasn't given us a particular specific biological mechanism.

[00:06:00] Speaker 02:
So applying that new standard, the Boatman standard, to Alton Prong I, replacing the plausible medical theory standard, has done away with that protection that Alton was supposed to be there for.

[00:06:15] Speaker 02:
Alton has been petitioner's protection ever since it was written, which is like 17 years ago.

[00:06:21] Speaker 02:
We don't have to provide medical literature.

[00:06:25] Speaker 02:
We don't have to provide a vaccine footprint for the injury.

[00:06:30] Speaker 02:
We don't have to have the specific homology when there is molecular mimicry and all of those things.

[00:06:40] Speaker 00:
Um, that last bit seems to me to be in a potentially different category.

[00:06:44] Speaker 00:
That is the, the reasons for alpha and saying you don't need medical literature is that I think you just explained that the cases that get litigated on, on,

[00:06:55] Speaker 00:
causation non-table cases are one in which the issue is not settled in the literature.

[00:07:02] Speaker 00:
But that doesn't mean that, and therefore you can put on your expert to say, here's why I think this is actually

[00:07:15] Speaker 00:
Why, I think that there's causation, even though there's no general consensus about it yet.

[00:07:21] Speaker 00:
But often doesn't say you don't need that kind of evidence at a level of detail, like this is the kind of molecule for which homology would work.

[00:07:35] Speaker 02:
If I'm understanding your question correctly, I think I am.

[00:07:39] Speaker 02:
We put on evidence, instead of taking it from the hypothetical, just apply it to this case.

[00:07:45] Speaker 02:
We put on a dual board certified medical doctor who treats ITP, researched and published an ITP.

[00:07:53] Speaker 02:
So you're absolutely right.

[00:07:54] Speaker 02:
He said, this is how it would work.

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This is how the Prevnar vaccine could trigger ITP in a susceptible host.

[00:08:03] Speaker 02:
And he put that very evidence you're talking about, we put that on.

[00:08:07] Speaker 02:
Look at the criticism we got from the special master.

[00:08:12] Speaker 02:
Where's your epidemiology?

[00:08:13] Speaker 02:
That was expressly the sort of thing that Alpha and Prong 1 was to protect us against having to do.

[00:08:20] Speaker 02:
There is no epidemiology.

[00:08:22] Speaker 02:
What's your specific bio, not just that it could be a biological mimic, a molecular mimic, but what is it?

[00:08:31] Speaker 02:
He wanted literally, he said, where is your sequencing?

[00:08:36] Speaker 02:
We want the amino acid sequencing.

[00:08:39] Speaker 02:
It's got to be published.

[00:08:40] Speaker 02:
Well, people aren't doing research on that.

[00:08:42] Speaker 02:
We don't know what this specific mimic would be.

[00:08:45] Speaker 02:
And he said, even if you had that, that wouldn't be enough.

[00:08:48] Speaker 00:
Is the fact finder here at the Special Master allowed to demand any kind of support?

[00:08:57] Speaker 00:
Or is it enough for somebody with credentials to simply assert it?

[00:09:04] Speaker 02:
No.

[00:09:04] Speaker 02:
He has discretion.

[00:09:06] Speaker 02:
If Alton Crong won,

[00:09:08] Speaker 02:
plausible medical theory standard applies still.

[00:09:11] Speaker 02:
If that's still the law in this program, which special master, as you read, said it is not.

[00:09:17] Speaker 02:
But then we have to present a plausible medical theory.

[00:09:20] Speaker 02:
Absolutely the person needs to be qualified to say it.

[00:09:23] Speaker 02:
They have to present the theory.

[00:09:25] Speaker 02:
And the special master here said

[00:09:27] Speaker 02:
Expressly, you've presented a plausible medical theory.

[00:09:31] Speaker 02:
However, that's not the standard anymore.

[00:09:34] Speaker 02:
That should have been the end of the analysis.

[00:09:36] Speaker 00:
I thought the special master said you presented a theory that as a general matter with respect.

[00:09:43] Speaker 00:
is plausible in some context, namely molecular mimicry, but you haven't shown me, I don't remember whether he again used the word plausible, but you haven't shown me that that theory plausibly applies to this particular set of molecules.

[00:10:04] Speaker 02:
Yeah, I think what you're referring to is, it was on the next page of the decision, and he said even if you provided me a molecular mimic,

[00:10:13] Speaker 02:
you haven't provided the application of that mimic to this child, which is you have the phenotype and the application.

[00:10:26] Speaker 02:
That's stunningly impossible.

[00:10:30] Speaker 02:
I mean, I want you to understand what that means.

[00:10:35] Speaker 02:
That means even if we had

[00:10:38] Speaker 02:
a molecular mimic that was published.

[00:10:41] Speaker 02:
We have that scientific certainty of how the vaccine could cause it.

[00:10:45] Speaker 02:
What that criticism was about was alpha and prong 2.

[00:10:49] Speaker 02:
You haven't shown me how that mimic, if that mimic actually works in this child.

[00:10:57] Speaker 02:
For instance, if we had a child who had an autoimmune encephalitis, if you take what he said literally, what that means is that I want to see that this child's brain, in fact, functions or is attacked by that particular mimic.

[00:11:18] Speaker 02:
But, Your Honor, the question the special master said, this is not a point of debate, I don't think.

[00:11:26] Speaker 02:
Alton Prong I is not the law anymore.

[00:11:29] Speaker 02:
He said that Boatman replaced it.

[00:11:31] Speaker 02:
And what Boatman replaced it with is the sound and reliable standard.

[00:11:37] Speaker 02:
And sound and reliable, according to this special master, and I think, in fact, it probably is what it... I mean, it's from Dow there.

[00:11:48] Speaker 02:
What that means is that the Boatman majority overturned Alton Prong I.

[00:11:56] Speaker 02:
and implanted sound and reliable into the Alton Prong 1 standard, which means scientific certainty.

[00:12:04] Speaker 02:
That's why his criticism of our proof was that you haven't presented epidemiology.

[00:12:12] Speaker 02:
You didn't present direct medical literature where the authors of the literature said, this vaccine does cause this injury, and here's how it does it.

[00:12:23] Speaker 02:
You didn't show me the specific mimic that could cause it.

[00:12:28] Speaker 02:
The fact that molecular mimicry could generally isn't good enough.

[00:12:34] Speaker 02:
He found we had a medically plausible theory, and he said that's not the standard.

[00:12:39] Speaker 02:
And he specifically said Boatman overturned Alphenprong 1.

[00:12:43] Speaker 02:
That was his reasoning.

[00:12:46] Speaker 02:
And we believe that that is error.

[00:12:48] Speaker 02:
And we asked this court to solve fine.

[00:12:52] Speaker 01:
You're into your rebuttal time.

[00:12:56] Speaker 01:
You can use it or continue as you wish.

[00:12:59] Speaker 01:
I want to quickly get into the fact finding.

[00:13:01] Speaker 01:
The special master... When you want to answer the question that was asked first to make you defer it.

[00:13:09] Speaker 01:
Is there a question in?

[00:13:10] Speaker 01:
No, continue.

[00:13:13] Speaker 01:
It's your time to use it if you prefer.

[00:13:16] Speaker 02:
On the fact finding, the special master criticized Petitioner's lack of production of evidence that CL had symptoms of ITP in 2013.

[00:13:27] Speaker 02:
However, absent from his fact finding, and this is not a complete list,

[00:13:33] Speaker 02:
The bruising did not cause discomfort.

[00:13:37] Speaker 02:
That's ITP bruising that was in the fall of 2013.

[00:13:41] Speaker 02:
Didn't make it into his fact-finding.

[00:13:43] Speaker 02:
There were no incidents that caused the bruising that was seen.

[00:13:46] Speaker 02:
That didn't make it into his fact-finding.

[00:13:48] Speaker 02:
The bruising on the nail bed is the same type of bruising that happens now with ITP flares.

[00:13:54] Speaker 02:
That didn't make it into his fact-finding.

[00:13:57] Speaker 02:
With years of experience, Mrs. Lloyd knows when the ITP is flaring because of behavioral changes.

[00:14:06] Speaker 02:
That happened in 2013.

[00:14:07] Speaker 02:
That didn't make into his fact-finding.

[00:14:10] Speaker 02:
Dr. Gershwin's patient who had normalization of blood levels when exposed to an immune challenge, that didn't make into his fact-finding.

[00:14:24] Speaker 02:
The group of photos as a whole

[00:14:27] Speaker 02:
Uh, he, um, he looked at them individually, but not as a group.

[00:14:32] Speaker 02:
As a group, it shows a kid with bruising from head to toe who nine months later receives her diagnosis of ITP, a disorder that by its very nature, uh, can take a while to diagnose.

[00:14:46] Speaker 02:
That didn't make it into his fact-finding.

[00:14:48] Speaker 02:
What could this, this lady was taking, this lady bubble wrapped the furniture in 2013.

[00:14:57] Speaker 02:
She took pictures of her child's bruising in 2013.

[00:15:00] Speaker 02:
Who does that?

[00:15:03] Speaker 02:
The fact that the formal diagnosis was made nine months later, what caused all of that?

[00:15:08] Speaker 02:
That didn't make it into a fact finding.

[00:15:11] Speaker 02:
We asked this court to order the special master to go back and put our evidence into a fact finding.

[00:15:16] Speaker 02:
He can't just pick and choose and leave our evidence out.

[00:15:21] Speaker 02:
It wasn't there.

[00:15:22] Speaker 01:
Thank you, counsel.

[00:15:23] Speaker 01:
Your time has expired.

[00:15:25] Speaker 01:
I will give you two minutes for a bottle.

[00:15:29] Speaker 03:
King?

[00:15:30] Speaker 03:
May it please the Court, Tyler King, for Respondent Appellee, Secretary of Health and Human Services.

[00:15:36] Speaker 03:
Good morning, Your Honors.

[00:15:38] Speaker 03:
First off, I will be asking this Court to affirm the decision of the Chief Special Master denying this petition.

[00:15:45] Speaker 03:
I will pick off where the petitioner left off regarding the factual inquiry.

[00:15:51] Speaker 03:
The Chief Special Master as an independent fact finder considered all facts presented in this case and came to the conclusion that the onset of the petitioner's ITP occurred in May of 2014.

[00:16:07] Speaker 03:
Now, he came to this conclusion after review of the evidence.

[00:16:11] Speaker 03:
Now, the evidence that was not discussed there

[00:16:14] Speaker 03:
Includes the fact that this should.

[00:16:16] Speaker 00:
What about the evidence that counsel on the other side says he did not discuss?

[00:16:25] Speaker 03:
Regarding the photos, these photos were also reviewed by a respondents expert.

[00:16:31] Speaker 03:
Now, a respondents expert included a hematologist, the only one that was here for this case, and a pediatric immunologist.

[00:16:39] Speaker 03:
So a petitioner's expert was an immunologist as well.

[00:16:44] Speaker 03:
Both the respondents' experts reviewed the photos and they said this was normal bruising, the type that would typically be seen in a child.

[00:16:51] Speaker 00:
They also concluded that the medical records, which the child after the August vaccination in 2013... And did the special master discuss the evidence that you just were recounting or you're just describing evidence that's in the record that the special master did not discuss?

[00:17:11] Speaker 03:
He did discuss it.

[00:17:11] Speaker 03:
He noted that

[00:17:14] Speaker 03:
The pictures provided lacked any type of metadata.

[00:17:16] Speaker 03:
They were difficult to see.

[00:17:19] Speaker 03:
I am sorry.

[00:17:20] Speaker 00:
I guess I'm just trying to focus on, and you know the specifics better than I do.

[00:17:25] Speaker 00:
I thought that Mr. Gage said there was some important evidence bearing on the question of onset that the special master did not discuss.

[00:17:36] Speaker 00:
Is that true?

[00:17:37] Speaker 03:
No.

[00:17:38] Speaker 03:
He carefully considered all the evidence as the independent fact finder.

[00:17:43] Speaker 03:
He came to his conclusion that onset occurred in May of 2014.

[00:17:47] Speaker 03:
The other factors that he also considered were the child did present to multiple providers from the time of vaccination to a diagnosis.

[00:17:57] Speaker 03:
Now, these medical appointments did not feature any notations of bruising.

[00:18:02] Speaker 03:
They did not feature any notations by the mother that there was bruising or concern.

[00:18:09] Speaker 03:
In fact, in February of 2014,

[00:18:13] Speaker 03:
the child had a blood platelet test done.

[00:18:17] Speaker 03:
Now this blood platelet test was found to be for 330,000 blood platelets.

[00:18:23] Speaker 03:
So in order to confirm ITP, that would be anything less than 100,000.

[00:18:28] Speaker 03:
And this is where the chief special master, he focused on his issues with petitioner's theory that there was nothing presented to explain how you would have

[00:18:41] Speaker 03:
for nine months, this child that did not appear to have any symptoms and had this blood platelet test of 330,000, and then all of a sudden dropped to, in June, it was 30,000.

[00:18:54] Speaker 03:
And responded, presented experts that even testified any type of waxing and waning you would expect would be to the extent of 20,000 to 30,000 blood platelets, not a precipitous drop from 340,000 down to, I believe it was 30,000.

[00:19:15] Speaker 00:
Is it your view that the factual finding by the special master, that onset didn't occur until May of 2014 or June, is dispositive of the appeal?

[00:19:29] Speaker 00:
Yes.

[00:19:30] Speaker 00:
Without getting into the questions about whether there has been a departure from Alphen?

[00:19:39] Speaker 03:
Yes.

[00:19:41] Speaker 03:
The courts affirming the Chief Special Master's holding, that would prove that Petitioner did not meet their burden under prong three.

[00:19:49] Speaker 03:
And if they didn't meet their burden under prong three, then there's no need for further analysis.

[00:19:54] Speaker 03:
Furthermore, Petitioner's own expert in this matter agreed with the Chief Special Master that if there was an onset between five to 10 months, that would be well outside the timeframe for causation by vaccination.

[00:20:13] Speaker 03:
Moving on to the next point that Petitioner raised, the Chief Special Master correctly held Petitioner to their burden, which is a proof by a preponderance of the evidence of a medical theory causally connecting the vaccine with the injury.

[00:20:30] Speaker 03:
In this case, he properly noted that Petitioner, outside of identifying the Prednar vaccine, had not proved by a preponderance of an evidence that it could cause ITP.

[00:20:44] Speaker 03:
As far as the studies mentioned by petitioner, the chief special master noted in his decision that that is not required.

[00:20:52] Speaker 03:
However, this was brought up by a petitioner, so he addressed it.

[00:20:57] Speaker 03:
There were no studies brought forth by petitioner.

[00:20:59] Speaker 03:
Actually, I have a mistake.

[00:21:00] Speaker 03:
They presented a study called Wong, which respondents expert Dr. Strauss noted

[00:21:07] Speaker 03:
featured an adult male that was undergoing a kidney transplant and thus not dispositive of whether vaccinations and ITP could be linked.

[00:21:19] Speaker 03:
And so otherwise, he noted all of the studies provided by Petitioner.

[00:21:24] Speaker 03:
And none of these studies stood for this proposition showing any type of link between ITP and the Prevnar vaccine.

[00:21:33] Speaker 03:
Furthermore, Petitioner would even submit

[00:21:36] Speaker 03:
Petitioner's experts even was confused about thrombocytis and ITP.

[00:21:41] Speaker 03:
Thrombocytis is a disorder that has the opposite effect.

[00:21:44] Speaker 03:
So that would be the blood platelets would go up versus ITP, you would have a reduction of the blood platelets.

[00:21:51] Speaker 03:
All of this is dispositive when evaluating respondents' experts, petitioner's experts, and such.

[00:21:59] Speaker 03:
Regarding the molecular mimicry, the chief special master carefully noted

[00:22:05] Speaker 03:
that you can't just chant the words molecular mimicries.

[00:22:09] Speaker 03:
Otherwise, you would be able to just say any vaccine is caused by any injury.

[00:22:13] Speaker 03:
And because you say it, we have to take your word for it.

[00:22:17] Speaker 03:
So he carefully went through and found that the petitioner had not met their burden by preponderance of the evidence.

[00:22:25] Speaker 03:
If this court has no further questions.

[00:22:29] Speaker 01:
Thank you, Mr. King, Mr. Gage.

[00:22:34] Speaker 02:
As counsel declined to answer, those facts, testimony of the mother, facts of what happened, the testimony of our doctor that I outlined, none of that was put into the special master's analysis of this case.

[00:22:53] Speaker 02:
Those facts were all left out.

[00:22:55] Speaker 02:
Those were the facts that it would be extremely hard to explain away, so they were just left out.

[00:23:02] Speaker 02:
So absolutely is not true.

[00:23:06] Speaker 02:
He did not consider our case.

[00:23:07] Speaker 02:
He considered a respondent's case.

[00:23:09] Speaker 02:
And I believe that's error.

[00:23:11] Speaker 02:
In fact, it directly violates subsection 13A1's mandate that special masters consider the record as a whole as an absolute violation of that.

[00:23:22] Speaker 02:
When counsel says they didn't meet their burden, the question is, what's the burden?

[00:23:30] Speaker 02:
I mean, if the special master expressly said that we satisfied the old standard under Alphenprong 1, he said it, the medically plausible theory, and then he said, he wasn't mincing words, the medical plausible theory from Alphenprong 1 is no longer the law.

[00:23:47] Speaker 02:
He says that Boatman replaced that.

[00:23:50] Speaker 02:
And Boatman is sound and reliable.

[00:23:53] Speaker 02:
That language comes from Dalbert.

[00:23:56] Speaker 02:
So we have Dalbert

[00:23:58] Speaker 02:
overturning Alton Prong One's language.

[00:24:00] Speaker 02:
That's what he said.

[00:24:02] Speaker 02:
I mean, he wasn't mincing words.

[00:24:05] Speaker 02:
And then he criticized us for not having epidemiology, direct medical literature, direct proof of mechanism.

[00:24:12] Speaker 02:
Those are all the things that Alton Prong One said

[00:24:15] Speaker 02:
petitioners don't have to do.

[00:24:17] Speaker 02:
That was the reason for Althon to be decided.

[00:24:21] Speaker 02:
That's what the Stevens decision earlier said that petitioners were going to need.

[00:24:26] Speaker 02:
And this court in Althon said petitioners don't need that.

[00:24:32] Speaker 02:
So we didn't meet our standard well.

[00:24:35] Speaker 02:
What was the standard?

[00:24:36] Speaker 02:
And Respondent failed to even address that issue.

[00:24:41] Speaker 02:
That's all I have.

[00:24:41] Speaker 02:
Thank you.

[00:24:42] Speaker 01:
Thank you, counsel.

[00:24:43] Speaker 01:
The case is submitted.