[00:00:00] Speaker 03:
We will hear argument next in number 232230, Stratton against HHS.

[00:00:11] Speaker 01:
Good morning, Your Honors.

[00:00:13] Speaker 01:
May it please the court?

[00:00:15] Speaker 01:
This is actually the fourth time since 2017 that I've said before this court to argue about the meaning and application of the reasonable basis provision in the Vaccine Act.

[00:00:25] Speaker 01:
The court may have figured out that I have taken a personal interest in this issue, and I want to start out by thanking the court for its engagement.

[00:00:33] Speaker 01:
Congress certainly did us no favors by enacting what seems like a unique fee-shifting scheme and then failing to define key terms in it like reasonable basis.

[00:00:45] Speaker 01:
Unfortunately, the legislative history is similarly unhelpful in determining what reasonable basis means.

[00:00:52] Speaker 01:
For its part, the Supreme Court in Bruceowitz v. Wyatt stated that attorney's fees are provided not only for successful cases, but even unsuccessful claims that are not frivolous.

[00:01:04] Speaker 01:
We think the not frivolous part of that statement is referring to the reasonable basis provision, but the Supreme Court hasn't otherwise elaborated on that.

[00:01:12] Speaker 01:
So through its opinions in Simmons, Cottingham, and James Cornelius, the government believes this court has crafted a workable standard that strikes the appropriate balance between setting parameters for the special masters to apply, while also granting them discretion in weighing the evidence.

[00:01:30] Speaker 01:
However, the standard only works if the special masters apply it.

[00:01:35] Speaker 01:
And the problem with the chief special master's decision in this case is that we don't know what standard he applied because he did not provide any explanation for his rationale for concluding that the claim in this case had a reasonable basis.

[00:01:49] Speaker 01:
Or as my seventh grade algebra teacher, Ms.

[00:01:51] Speaker 01:
Striggers, would have said, he didn't show his work.

[00:01:55] Speaker 03:
So if this were a straight arbitrary and capriciousness review standard,

[00:02:01] Speaker 03:
One might borrow from the most recent formulation that arbitrary and capricious requires that the agency action be reasonable, that's a substantive thing, and reasonably explained, that's a process thing.

[00:02:21] Speaker 03:
Does that?

[00:02:22] Speaker 03:
directly apply here or indirectly apply here?

[00:02:26] Speaker 01:
I think it could indirectly apply here.

[00:02:29] Speaker 03:
Do we agree that this decision is reviewed for abusive discretion rather than arbitrary capriciousness?

[00:02:40] Speaker 03:
Or is arbitrary capriciousness a form of abusive discretion?

[00:02:44] Speaker 03:
I'm trying to fit those things together.

[00:02:47] Speaker 01:
We have argued in our brief that the

[00:02:50] Speaker 01:
The special master's failure to articulate the reasons behind his conclusion that the claim had a reasonable basis was legal error because he doesn't specifically articulate the standard that the court has handed down.

[00:03:05] Speaker 01:
He just calls it an easier to meet standard than the preponderance standard.

[00:03:09] Speaker 01:
And then summarily concludes that the standard was met in this case.

[00:03:13] Speaker 03:
I'm having, I think, some trouble seeing how a failure to give a reason is a legal error.

[00:03:22] Speaker 01:
What we have argued is because it's impossible to discern from the special master's decision what standard he applied.

[00:03:30] Speaker 01:
He did not quote the Cottingham standard.

[00:03:33] Speaker 01:
He cited Cottingham, but then he just said,

[00:03:35] Speaker 01:
It's a lenient standard.

[00:03:37] Speaker 01:
It's an easy-to-meet standard.

[00:03:39] Speaker 01:
And that does not comport with the more than a Maricentella and less than a preponderance standard that this court has articulated in Cottingham and James Cornelius.

[00:03:48] Speaker 01:
So we do think that there is legal error in the sense that it's not clear from the decision what standard he actually applied.

[00:03:56] Speaker 01:
But we then do go on to also argue that it was arbitrary and capricious based on the evidentiary record for him to conclude that there was a reasonable basis for the decision.

[00:04:05] Speaker 01:
I'm not familiar with the cases that you're discussing that talk about arbitrary and capricious requiring both reasonableness and reasonable explanation.

[00:04:13] Speaker 03:
It was just a useful condensed formulation of, I think, the two ideas that have been kicking around in arbitrary and capricious law.

[00:04:21] Speaker 03:
for a very long time.

[00:04:23] Speaker 03:
I think the first formulation that I know is FCC against Prometheus Radio, and then it was repeated last year in the Ohio EPA case, because it just encapsulates that arbitrary and capriciousness has not only a substantive inquiry, but also a process inquiry, the process meaning.

[00:04:41] Speaker 03:
You actually have to discuss the important stuff.

[00:04:44] Speaker 03:
And I take it that the heart of your objection here is that

[00:04:49] Speaker 03:
The most important piece of the basis for compensation, namely causation, just isn't discussed at all.

[00:04:57] Speaker 01:
That's exactly correct.

[00:04:58] Speaker 01:
And if the court were to hold that the cases that you're discussing apply within the context of the Vaccine Act reasonable basis terminations, then we think that the decision is reversible under just a straight arbitrary and capricious standard.

[00:05:12] Speaker 04:
Can I ask you what you think needs to be discussed to show a reasonable basis?

[00:05:17] Speaker 04:
Because there is some reference to

[00:05:20] Speaker 04:
the fact that she got a vaccine and that she had some symptoms consistent with the vaccine in the record.

[00:05:31] Speaker 04:
And then I think there's some in the record, but not discussed, medical journals or something like that that link the vaccine with an injury.

[00:05:41] Speaker 04:
Correct.

[00:05:45] Speaker 04:
Wondering is it, and this is I think a tangent of Judge Truntz's question, is the problem here that the special master didn't explain why the evidence in the record met that very low reasonable basis threshold?

[00:06:03] Speaker 04:
Or can we just look at the evidence in the record and say, well,

[00:06:08] Speaker 04:
that would support his findings even if they were unexplained.

[00:06:12] Speaker 04:
And I understand what you're concerned here, because this is not a one-off.

[00:06:15] Speaker 04:
There are lots of these cases.

[00:06:18] Speaker 04:
And we need to understand the basis for his reasonable basis finding, and so does the Court of Federal Claims, if we're going to review them even under the very deferential standard.

[00:06:30] Speaker 01:
Correct.

[00:06:31] Speaker 01:
My response to that is that in Cottingham, the court made clear that to establish a reasonable basis, the petitioner is required to submit more than a maricinto of objective evidence on each of the elements of the petitioner's claim, which are the elements that are set out in Section 11C1 of the Act.

[00:06:49] Speaker 04:
Does that include causation?

[00:06:51] Speaker 01:
It does include causation.

[00:06:52] Speaker 01:
The court in Cottingham specifically said that the issue in Cottingham was causation and that it was the petitioner's burden to show that there was a more than missing cell evidence of a causal link to establish a reasonable basis.

[00:07:07] Speaker 04:
Even if we read the special master's decision generously, I don't find any suggestion of causation on this record.

[00:07:17] Speaker 04:
He sets the right standards, but he doesn't discuss causation.

[00:07:21] Speaker 04:
Am I supposed to be inferring from his reference to medical evidence that that includes the causation evidence?

[00:07:30] Speaker 01:
I don't know, and I think that's the problem with this decision, is we just don't have any idea what evidence he had in mind when he made that summary conclusion that there was a reasonable basis.

[00:07:40] Speaker 03:
We would argue that... So in Cottingham, there were two pieces put together that I think this court said

[00:07:50] Speaker 03:
actually thought until I got to the end of the opinion that it was going to say, is enough.

[00:07:55] Speaker 03:
Instead, it said, this is all objective evidence supportive, and then said, but that's ultimately up to the special master.

[00:08:03] Speaker 03:
So remand.

[00:08:04] Speaker 03:
But the two pieces were various diagnoses of certain conditions, and then finding those conditions referred to in the package insert.

[00:08:15] Speaker 03:
Are the conditions here POTS and the other one?

[00:08:20] Speaker 03:
referred to in package insert or not?

[00:08:23] Speaker 01:
POTS is not referred to in the package insert and what Petitioner here is arguing is that it's not so much the POTS diagnosis but the symptoms associated with the POTS diagnosis that are on the package insert, the syncope, the dizziness, the headaches.

[00:08:39] Speaker 01:
And you're correct, that in Cottingham, the issue was remanded back to the special master to consider the product insert in conjunction with the medical literature, which is basically the same medical literature that's been submitted in this case, the affidavit, the medical records.

[00:08:55] Speaker 01:
And the special master went through an exhausting detail, the regulatory scheme behind how the product inserts are put together.

[00:09:02] Speaker 01:
And basically concluded that the only section that really is pertinent to a causation analysis is... I'm sorry, and you're not describing what happened on remand?

[00:09:09] Speaker 01:
On the remand, but in his discussion of the product insert, there's a section for adverse reactions, and that is the only section which, in the regulations, it says the manufacturers have acknowledged that there's some basis for assuming a causal relationship.

[00:09:23] Speaker 01:
And that section, it limits those particular symptoms, the headache, the syncope, our dizziness and fainting, to within 15 days of vaccination.

[00:09:33] Speaker 01:
And so the special master concluded anything beyond that, there really isn't a basis for concluding that those symptoms would have been caused by the vaccine.

[00:09:41] Speaker 01:
The latency in Cottingham was four months.

[00:09:45] Speaker 01:
And the special master basically concluded that was too long to establish a reasonable basis in that case.

[00:09:52] Speaker 01:
The latency here is anywhere from 14 to 20 months.

[00:09:56] Speaker 01:
The records show that, first of all, that Ms.

[00:09:59] Speaker 01:
Stratton was complaining of these same symptoms in the two years prior to vaccination.

[00:10:03] Speaker 01:
Then there's this eight-month period post-vaccination where she seeks routine medical care for completely unassociated problems, just

[00:10:10] Speaker 00:
So just to kind of follow up on their two questions, would it be necessary for the Chief Special Master to discuss kind of these pre-vaccination symptoms as well?

[00:10:20] Speaker 00:
You know, beneath the reasonable basis standard in your view?

[00:10:22] Speaker 01:
So as a practical matter, we filed an objection to the fee application in which we raised these specific issues.

[00:10:28] Speaker 01:
And so going back to your question about what is the Special Master required to address,

[00:10:33] Speaker 01:
I think arguably the special master is required to address each of the elements of the petitioner's case.

[00:10:38] Speaker 01:
But as a practical matter, we flag which issues we think that the record does not support.

[00:10:44] Speaker 01:
And so I think at a minimum, the special master should be required to address those issues.

[00:10:48] Speaker 03:
Right.

[00:10:49] Speaker 03:
At least, I thought Judge Gunningham was asking about not just to address symptoms that arose or reported after the vaccine, but a set of medical conditions that are in medical records preceding the vaccine, which may have some bearing on whether similar post-vaccine conditions had a causal relationship to the vaccine.

[00:11:16] Speaker 01:
Absolutely.

[00:11:17] Speaker 01:
And we flagged those.

[00:11:18] Speaker 01:
We raised those issues and our objection that we filed to the application.

[00:11:23] Speaker 01:
We provided a medical summary of our review of the medical records, noted that there were symptoms predating the vaccination that seemed to be consistent with what Petitioner was claiming were caused by the vaccination, which is like a schematic that if they predated the vaccination, they couldn't have been caused by the vaccination.

[00:11:40] Speaker 00:
There were also some scholarly articles, right?

[00:11:42] Speaker 00:
Would those articles be things that the Chief Special Master should discuss in terms of the reasonable basis for causation?

[00:11:53] Speaker 01:
I think so.

[00:11:54] Speaker 01:
I mean, that is evidence that the petitioner specifically submitted in support of

[00:11:59] Speaker 01:
proving a reasonable basis for the claim.

[00:12:01] Speaker 01:
I mean, these are the same articles that Mr. Downing has submitted in the hundreds of cases that are being withdrawn from the program to go to the Merck and DL.

[00:12:10] Speaker 01:
And he submits them to try to establish a reasonable basis.

[00:12:14] Speaker 00:
Well, not these things, because I know your time is going to run out.

[00:12:17] Speaker 00:
There's at least some statements, I want to say, that were made in terms of

[00:12:21] Speaker 00:
what would happen in terms of growing fees after a certain time period and before a certain time period.

[00:12:28] Speaker 00:
I don't know if you want to address that in kind of your running time before you sit down.

[00:12:33] Speaker 01:
I would like to address that.

[00:12:34] Speaker 01:
We do have a concern about that, obviously, because it seems, again, a very arbitrary approach for the Special Master to be saying that he's going to award fees in cases filed before a certain date but not filed after a certain date without actually having looked at the evidence in those cases.

[00:12:50] Speaker 01:
Our position is that each case should be evaluated for a reasonable basis on the basis of its own evidentiary record.

[00:12:57] Speaker 01:
And drawing a line at whether they were filed before or after he issued the decision on the AtGN case to me goes more towards

[00:13:06] Speaker 01:
whether petitioners were on notice that they didn't have a good evidentiary basis for the claims.

[00:13:10] Speaker 01:
And that, to me, is more of a good faith issue, whether the case can be filed in good faith before or after a certain date.

[00:13:17] Speaker 01:
It doesn't go to the issue of reasonable basis, which this court has held as an objective evidentiary.

[00:13:23] Speaker 03:
Thanks.

[00:13:23] Speaker 03:
Just one quick question.

[00:13:25] Speaker 03:
Are fees available for work in getting fees?

[00:13:29] Speaker 01:
The court has typically allowed that.

[00:13:35] Speaker 01:
In general.

[00:13:36] Speaker 01:
In general.

[00:13:37] Speaker 03:
I mean outside the Vaccine Act context.

[00:13:40] Speaker 01:
Yes.

[00:13:42] Speaker 03:
Making this an elaborate inquiry might not be a great idea for the government paying fees.

[00:13:55] Speaker 01:
I think it's more of a principle issue for us that the case and it goes to discouraging petitioners from filing claims that don't have a reasonable basis.

[00:14:05] Speaker 01:
That's why we're looking for consistency among the special masters in how they resolve these issues so that petitioners can decide whether it's even worth filing a claim in the first place and we can know whether it makes sense to make an objection.

[00:14:18] Speaker 04:
I just want to follow up on that.

[00:14:20] Speaker 04:
How much do you think they actually would have to do?

[00:14:23] Speaker 04:
Because it seems to me, what we were talking about at the beginning at the special master, it said this person got the vaccine.

[00:14:30] Speaker 04:
She had symptoms consistent with injuries caused by the vaccine as supported by the scholarly journals in two or three sentences.

[00:14:41] Speaker 04:
You probably wouldn't be here, right?

[00:14:43] Speaker 01:
Right.

[00:14:44] Speaker 04:
I mean, if they were not turning this into a heightened merit standard, you just want some indication of the evidence for the three factors.

[00:14:56] Speaker 01:
Exactly.

[00:14:56] Speaker 01:
And we don't make these objections in very many cases.

[00:14:59] Speaker 01:
We really only do it when it's clear that there is a failure of evidence on one of the elements of the petitioner's claim.

[00:15:04] Speaker 03:
But I mean, you do.

[00:15:06] Speaker 03:
plan to look at those pieces of scholarly literature and say, look, they're unreliable.

[00:15:14] Speaker 03:
They actually don't quite match these conditions in the temporal characteristic or something else.

[00:15:26] Speaker 03:
Basically, pick them apart, I don't mean that in a pejorative sense, in a way that a merits decision on compensation would in fact do.

[00:15:35] Speaker 01:
Fortunately, most of this literature has already been dressed in reasoned decisions from the special masters dismissing HPV POTS claims.

[00:15:43] Speaker 01:
And so the special masters can just draw on the decisions that are already out there to basically say that these articles are not reliable evidence that the HPV vaccine causes POTS and other autonomic disorders.

[00:15:56] Speaker 02:
It's almost afternoon, so I can still say good morning, Your Honors.

[00:16:10] Speaker 02:
So a couple of things right out of the gate.

[00:16:14] Speaker 02:
To address the question that was asked about the information from the Chief Special Master that he intends to rule a certain way in the future, I do agree with Mr. Johnson on that point.

[00:16:25] Speaker 02:
I think if he and I are litigating this question and the Chief Special Master were to say, I'm only going to award this much and arbitrarily cut it off or whatever, and it's not reasonably based on evidence or so forth,

[00:16:40] Speaker 02:
One of us is going to appeal that.

[00:16:42] Speaker 02:
If it works to my disfavor, I'm going to be the appellant on that case.

[00:16:47] Speaker 02:
And if it's the reverse, it's probably going to be Mr. Johnson.

[00:16:51] Speaker 02:
But I think we really can't do anything with that until that happens.

[00:16:56] Speaker 04:
But the problem with that is it's because it doesn't give us the special master's views

[00:17:03] Speaker 04:
and rather is a reasonable basis in a particular case, which we need to review for arbitrary and capriciousness.

[00:17:12] Speaker 02:
I think that's absolutely correct, Your Honor, and so focusing on this.

[00:17:17] Speaker 04:
Yeah, my question in this case, because I think this is a very close case, is

[00:17:25] Speaker 04:
why is it sufficient when I can't discern from the special master's decision, even though I could probably go and dig in the record and find stuff, at least causation?

[00:17:38] Speaker 04:
Because he doesn't use the word, here's a reasonable basis for causation, as far as I can tell, or any kind of thing to that effect.

[00:17:48] Speaker 02:
So I think it's important in looking at the chief special master's decision to start with at appendix page 5, the chief articulated back to the government what their objections were, that the medical records don't sufficiently support the alleged symptoms, that the treating doctors didn't opine that Petitioner's HPV vaccine caused or contributed to the problems, and that Petitioner's affidavit shouldn't be afforded any weight.

[00:18:18] Speaker 02:
He then goes through saying that the skepticism about the claim's likelihood of success is reasonable, perhaps, but that's not the standard.

[00:18:30] Speaker 02:
He articulates what reasonable basis is.

[00:18:32] Speaker 02:
It is looking at the feasibility of the case.

[00:18:36] Speaker 02:
And as he then proceeds to say, he looked at the medical records.

[00:18:41] Speaker 02:
He uses his experience in dealing with other HPV cases, which special masters have the discretion to do.

[00:18:49] Speaker 02:
And then, again, as your honors noted, he indicates that this particular claimant experienced post-vaccination symptoms.

[00:18:57] Speaker 04:
But can you help me, is there anything more than this concluding sentence of paragraph 3 on page 5 that suggests this analysis of reasonable basis?

[00:19:12] Speaker 04:
That's all I could find when he says petitioners filed sufficient medical records to satisfy the exceedingly low of an injury standard.

[00:19:22] Speaker 02:
for the special masters to exercise their discretion, that is sufficient.

[00:19:28] Speaker 04:
So that's the question for us.

[00:19:30] Speaker 02:
That's right.

[00:19:31] Speaker 04:
That's my position.

[00:19:32] Speaker 04:
Why is that sufficient?

[00:19:34] Speaker 04:
How is this a sufficient explanation of how your client has met at least some minimum agreement on all the elements of the claims that we can review?

[00:19:46] Speaker 04:
So, you are at... Because I have a church that's really referential, but it's not, you know, it's not they hide behind that, you know, curtain and we can't do anything about it.

[00:19:59] Speaker 04:
I don't know what basis and what part of the medical record, I mean, maybe it required three sentences instead of one.

[00:20:08] Speaker 04:
What's wrong with that?

[00:20:09] Speaker 02:
Well, I think, I don't think that the special masters have to go through and lie on them.

[00:20:17] Speaker 02:
what they're doing.

[00:20:18] Speaker 04:
But there's a spectrum there.

[00:20:22] Speaker 04:
How can I review what the special master did here based upon solely that sentence?

[00:20:28] Speaker 02:
I think, Your Honor, if we then go to the decision from the Court of Federal Claims,

[00:20:34] Speaker 04:
I'm not going to go there.

[00:20:34] Speaker 04:
That's the problem is the special.

[00:20:36] Speaker 04:
The court kind of claims we had a really good decision and dug into the record a little bit more and found stuff.

[00:20:41] Speaker 04:
But I'm reviewing the special master's decision.

[00:20:44] Speaker 02:
Well, the decision on review here is Judge Lerner's affirmation of a chief special master, in which she specifically says, and I think this is the point to your question, medical records are sufficient to establish reasonable basis.

[00:20:58] Speaker 04:
Now, she gives a couple of examples.

[00:21:01] Speaker 04:
I know, but he didn't.

[00:21:03] Speaker 04:
And this is the problem going forward, is this special master needs to do a better job of writing his opinions.

[00:21:10] Speaker 04:
And it may not, I don't think it's very much, but if we didn't have the Court of Federal Claims decision, I would have no idea what he found reasonable about your case.

[00:21:21] Speaker 02:
And I understand that, Your Honor, but for Ms.

[00:21:23] Speaker 02:
Stratton,

[00:21:24] Speaker 02:
this is the decision that's on review.

[00:21:26] Speaker 02:
And there's very specific references to the medical chart.

[00:21:31] Speaker 02:
It would be nice if the chief special master had done that.

[00:21:35] Speaker 02:
I believe he exercised his discretion appropriately by looking at the medical chart, using his experience, because one of the reasons they have discretion here is because they're the ones seeing these cases on a day-to-day basis.

[00:21:48] Speaker 02:
The chief sees a lot of the Gardasil cases.

[00:21:51] Speaker 02:
He's familiar with the evidence and the causation theories, the medical literature, and so forth.

[00:21:57] Speaker 02:
And he specifically said he reviewed the medical chart and found the submission to be sufficient to warrant an award of attorney's fees.

[00:22:06] Speaker 02:
Would it have been nice if it had been more detailed?

[00:22:10] Speaker 02:
Perhaps.

[00:22:12] Speaker 02:
Did the Court of Federal Claims, as Your Honor said, dig in a little deeper and give specific citations to medical records that support the award of fees, that go further and support the Chief Special Master's decision that the medical chart was sufficient to award fees?

[00:22:28] Speaker 02:
She absolutely did.

[00:22:30] Speaker 02:
This case has reasonable basis.

[00:22:33] Speaker 02:
I can talk more about the standard.

[00:22:35] Speaker 02:
I don't know that you need to hear it.

[00:22:38] Speaker 04:
This case is a case we need to decide the standard in, because we have no idea what evidence he was relying on to determine whether it met the standard or not.

[00:22:50] Speaker 04:
That's another part of the problem here.

[00:22:52] Speaker 02:
Well, I understand what you're saying, Your Honor.

[00:22:54] Speaker 02:
But at the end of the day, when we look at what Judge Lerner did in affirming the cheat,

[00:22:59] Speaker 02:
In this case-specific analysis, you have witness, under oath witness statements.

[00:23:05] Speaker 02:
You have the medical chart that supports the vaccination.

[00:23:09] Speaker 04:
In case-specific analysis, the real problem here seems to be, because he also referenced that adogen decision, is he's decided he's not going to approach these on a case-by-case basis.

[00:23:21] Speaker 04:
And he just decided, you're going to get the fees up to this date, and you're not going to get them up to that date.

[00:23:29] Speaker 04:
And that's just how the jury increases.

[00:23:30] Speaker 02:
You agree with that?

[00:23:31] Speaker 02:
I do.

[00:23:32] Speaker 02:
I would agree with that, Your Honor.

[00:23:33] Speaker 04:
I would.

[00:23:33] Speaker 04:
And so that's his mindset.

[00:23:37] Speaker 04:
And he hasn't given us anything further to back it up in this specific case beyond a scant statement about medical evidence without identifying any of it.

[00:23:49] Speaker 04:
Why isn't it better to send it back to him and explain it?

[00:23:54] Speaker 04:
You're probably going to get the same conclusion that she had the vaccine, she had symptoms consistent, that at least at one point in time, there was medical or journal evidence that was at a reasonable basis, even if it might not be.

[00:24:13] Speaker 04:
I just find this very problematic that we're asked to determine whether something's arbitrary or capricious based on one almost contentless sentence.

[00:24:23] Speaker 02:
Well, I don't believe that we are trying to decide in Ms.

[00:24:27] Speaker 02:
Stratton's case whether what happened at the lower court is arbitrary or capricious.

[00:24:32] Speaker 02:
The arbitrary or capricious part comes in later in some future case, should the chief special master do what he has threatened

[00:24:40] Speaker 02:
to do in the Atogen and in the Stratton case.

[00:24:45] Speaker 02:
But that hasn't happened yet.

[00:24:47] Speaker 02:
And I think that he's heard already from me in subsequent briefing that it would be arbitrary and capricious to do that.

[00:24:58] Speaker 02:
And you're supposed to look at these on a case-by-case basis and exercise discretion.

[00:25:03] Speaker 03:
I'm going to return to something that I think I asked Mr. Johnson about.

[00:25:10] Speaker 03:
So medical records of the plaintiff all by themselves can't be enough for anything.

[00:25:24] Speaker 03:
what the medical records report has to be connected to some reasonable understanding of those conditions being connected to this vaccination.

[00:25:39] Speaker 03:
So it's a two-part thing, which is, I think, what Cottingham said has to be.

[00:25:45] Speaker 03:
Otherwise, I have medical records saying that my leg is broken.

[00:25:51] Speaker 03:
couldn't possibly have anything to do with Gardasil.

[00:25:54] Speaker 03:
I'm just assuming that.

[00:25:56] Speaker 03:
So there has to be something about the specific content, at which point Mr. Johnson says, you know, you're going to put in your medical literature, the published studies,

[00:26:14] Speaker 03:
And he's going to say, I'm going to pick those apart.

[00:26:18] Speaker 03:
And indeed, for it to be a reasonable basis to connect them, I have to be able to look at those studies and say, very, very bad study or very, very narrow study doesn't cover this condition when it came 14 to 18 months or 22 months after the vaccination.

[00:26:42] Speaker 02:
Well, I would say partly right, Your Honor.

[00:26:48] Speaker 02:
So I think we have to be very careful here saying that there has to be a causal leak expressed in the medical chart because it can promise you

[00:27:00] Speaker 02:
If I had a dollar for every case where a doctor said it was vaccine related in the medical chart, I'd have about a dollar.

[00:27:07] Speaker 03:
I didn't take that to actually... Why would that not be sufficient?

[00:27:15] Speaker 03:
That is, a treating doctor says, I think this is connected.

[00:27:24] Speaker 03:
Do you think that that ought to be sufficient?

[00:27:27] Speaker 03:
Or I think Mr. Johnson's view is that's not sufficient, because that may just be completely unreasonable.

[00:27:36] Speaker 03:
The fact that one doctor says it doesn't mean it's reasonable.

[00:27:39] Speaker 02:
Well, Your Honor, to answer that, I think I would say if we have a doctor in the treating medical chart that hypothesizes a causal connection between vaccination and the injury, it gets much easier for a petitioner in the program to demonstrate reasonable basis.

[00:27:58] Speaker 02:
But typically what you have, and what I think is present in most of these cases, is you have an injury.

[00:28:05] Speaker 02:
And just as you say, your broken leg, it's probably not related to Gardasil.

[00:28:09] Speaker 02:
But if you have POTS, on the other hand, where the literature is continuing to develop, even there's literature that has come up, even since the chief special master issued this decision, that is continuing to connect Gardasil and POTS.

[00:28:28] Speaker 02:
So if a petitioner has POTS and symptoms start post-vaccination,

[00:28:35] Speaker 02:
You're starting to satisfy the elements of a claim.

[00:28:39] Speaker 02:
You got a vaccination in the United States.

[00:28:41] Speaker 02:
You pled an injury.

[00:28:42] Speaker 02:
The injury started after the shot.

[00:28:45] Speaker 02:
It's supported by medical literature.

[00:28:47] Speaker 02:
The medical chart corroborates the allegations.

[00:28:50] Speaker 00:
What about the time frame though?

[00:28:52] Speaker 00:
I know that opposing counsel talked about it being 20 months or so when some of these particular symptoms were showing up.

[00:28:59] Speaker 00:
How is the timeframe relevant in this case?

[00:29:02] Speaker 02:
Well, the timeframe is, I think, always relevant because if it's too far removed, then it isn't reasonable.

[00:29:07] Speaker 02:
But that's not when symptoms started.

[00:29:11] Speaker 02:
That's when she gets a full-blown POTS diagnosis and starts having significant problems, and that is 100% consistent with this disease.

[00:29:20] Speaker 02:
The Kineshita article that we submitted, and I don't have the exact appendix number in front of me, defines the onset need for this disease to be about five months post-trigger.

[00:29:33] Speaker 02:
But most of these individuals don't get a formal POTS diagnosis for five to seven years.

[00:29:39] Speaker 00:
What about the pre-vaccination symptoms that were also

[00:29:43] Speaker 00:
in the medical records.

[00:29:44] Speaker 00:
What's your response to those and the overlap?

[00:29:46] Speaker 02:
Well, I mean, my response would be they're unrelated to the ultimate disease that she developed.

[00:29:51] Speaker 02:
And that would be a fact question that ultimately, if this case had stayed in the vaccine program, we would have gotten experts.

[00:29:56] Speaker 02:
We would have had an autonomic neurologist that opined that those predated vaccination symptoms are irrelevant.

[00:30:04] Speaker 02:
Or if they are relevant, perhaps the vaccination significantly aggravated an underlying process.

[00:30:09] Speaker 02:
But we didn't get that far.

[00:30:10] Speaker 02:
because this particular petitioner exercised her right to opt out at 240 days.

[00:30:15] Speaker 02:
So I think those are all valid questions, but they don't go to whether this case had reasonable basis at the inception.

[00:30:23] Speaker 02:
As we've talked about, it's a very low threshold.

[00:30:26] Speaker 02:
What I think you're describing, Your Honor, is more of a causation analysis to win on entitlement.

[00:30:33] Speaker 02:
where a petitioner has a full bloom, burden-proof, you've got to satisfy more elements than what we do for reasonable basis.

[00:30:39] Speaker 00:
Because honestly, I think it really is more so this process issue that I would say both of my colleagues have been explaining.

[00:30:45] Speaker 00:
The lack of explanation, I'm going to say, that was actually put forth in terms of the reasonable basis analysis.

[00:30:52] Speaker 02:
Well, and again, Your Honor, all I can do to address that concern is to say

[00:30:58] Speaker 02:
Yes, the chief did not give a lot of detail in his decision, but I do not believe that level of detail is required.

[00:31:06] Speaker 02:
He cited why he did what he did.

[00:31:08] Speaker 02:
He's relying clearly on the medical chart, and that was submitted.

[00:31:12] Speaker 02:
But then, as is the process in the vaccine program, counsel appealed that and made these exact same arguments to Judge Lerner.

[00:31:22] Speaker 02:
And Judge Lerner did exactly what she is supposed to do.

[00:31:26] Speaker 02:
She looked at what the chief did.

[00:31:28] Speaker 02:
Was there a basis for it?

[00:31:30] Speaker 02:
And gave, as your honor said, a more detailed explanation.

[00:31:35] Speaker 02:
Like I said, it would be nice if the chief had done it.

[00:31:37] Speaker 02:
But he didn't.

[00:31:38] Speaker 02:
But Judge Lerner did.

[00:31:39] Speaker 02:
So for Ms.

[00:31:41] Speaker 02:
Stratton, I have all the elements necessary to have reasonable basis.

[00:31:47] Speaker 02:
This reasonable basis standard has plagued petitioners and respondents.

[00:31:52] Speaker 02:
in this court for years because it's just not congressionally defined.

[00:31:56] Speaker 02:
But what we do have is we have factors.

[00:31:59] Speaker 02:
that dictate which way that special masters go.

[00:32:03] Speaker 02:
Is there a reasonable basis or is there not?

[00:32:05] Speaker 02:
And it's almost 100% discretionary.

[00:32:09] Speaker 02:
I say almost because there's always review for abuse of that or what have you.

[00:32:13] Speaker 02:
But here, there is enough articulated in the chief's decision to support what he did.

[00:32:19] Speaker 02:
As I said at page five of the appendix, he articulated why he did what he did.

[00:32:26] Speaker 02:
It's not very illuminating.

[00:32:28] Speaker 02:
But it's why he did it.

[00:32:30] Speaker 02:
He relied on his own expertise, the medical chart, and the underlying facts of this specific case, and exercised that discretion.

[00:32:39] Speaker 02:
If I had a lot on the standard and all that, I don't think we need to get into that.

[00:32:43] Speaker 02:
So if you honors don't have any other questions for me, I think I'll rest.

[00:32:47] Speaker 03:
Well said.

[00:32:47] Speaker 03:
Thank you very much.

[00:32:51] Speaker 03:
Thank you, Your Honor.

[00:32:54] Speaker 03:
Mr. Johnson.

[00:32:56] Speaker 01:
Just a couple of very brief points.

[00:32:57] Speaker 01:
First of all, Mr. Downing kept mentioning that what the Chief Special Master threatened in Achean hadn't happened yet.

[00:33:04] Speaker 01:
It happened here.

[00:33:04] Speaker 01:
That's why we're here as an appellant.

[00:33:08] Speaker 01:
We saw that the Special Master said he was going to do it, and he did it, and so we appealed.

[00:33:12] Speaker 01:
On the idea that medical records can establish reasonable basis, I just wanted to

[00:33:17] Speaker 01:
Briefly, the record in this case is that Petitioner had symptoms two years prior to vaccination, then she's vaccinated in November of 2017.

[00:33:26] Speaker 01:
The following eight months has routine medical care for unrelated symptoms, and then at about January of 2019 begins experiencing symptoms that in July 2019 are diagnosed as POTS.

[00:33:37] Speaker 01:
So there is a blatant timing issue in this case.

[00:33:41] Speaker 01:
And what is missing is any attribution from any treating physician or an expert that links causally the vaccine to the later diagnosis of POTS 20 months later.

[00:33:51] Speaker 01:
And so that's, you asked a question about whether if there were a treating physician in the records who had

[00:33:57] Speaker 01:
said that the vaccine may have caused the condition, I think we would have considered that in determining whether to bring a reasonable basis of objection.

[00:34:04] Speaker 01:
I think that we would view that as some evidence, but it would depend on the context in which the doctor made that diagnosis, the expertise of the doctor making that diagnosis.

[00:34:15] Speaker 01:
Those would be factors that we would consider.

[00:34:17] Speaker 01:
But I think the statute talks in terms of that the special master can't find entitlement based on the claims of petitioner alone.

[00:34:25] Speaker 01:
unsubstantiated by medical records or medical opinion.

[00:34:28] Speaker 01:
And so those are the types of evidence we're looking for on the reasonable basis inquiry.

[00:34:32] Speaker 01:
Not necessarily sufficient to meet the preponderance standard, but just to get over them more than a nurse and teleprompter.

[00:34:40] Speaker 03:
Thank you.

[00:34:40] Speaker 03:
Thanks to both counselors.

[00:34:42] Speaker 03:
Case is submitted.

[00:34:44] Speaker 03:
And that brings our business to a close for today.