[00:00:00] Speaker 02:
Last case of the day to be argued is docket number 23-1315, KA versus HHS.

[00:00:12] Speaker 02:
Mr. Krakow, please begin whenever you're ready.

[00:00:14] Speaker 03:
Thank you, governor.

[00:00:15] Speaker 03:
Good morning.

[00:00:16] Speaker 03:
May it please the court.

[00:00:18] Speaker 03:
This is a case where a vaccine injured petitioner was denied the opportunity to present evidence

[00:00:26] Speaker 03:
That was central to the case, central to the respondent's expert's presentation.

[00:00:31] Speaker 03:
That is, that there was an infectious disease that more likely caused the injury, and was denied the opportunity to present his expert in infectious disease and biostatistics, even though the decision ultimately focused on those issues.

[00:00:50] Speaker 03:
The court below, the special master, noted the appearance

[00:00:57] Speaker 03:
of an upper respiratory infection, which was undefined, undiagnosed, unspecified, mere cluster of symptoms, was more likely an infectious disease.

[00:01:10] Speaker 03:
We offered an offer of proof and a formal motion to present the expert testimony of an infectious disease specialist because we were concerned that

[00:01:23] Speaker 03:
the presentation of our neurologist, who is a National Academy of Sciences member and so on, but in neurology, would testify outside the scope of his expertise.

[00:01:34] Speaker 02:
My understanding of the expert you wanted to add to the record that could comment on infectious diseases, that could potentially have helped you with what I'll call alpha and prong two.

[00:01:48] Speaker 02:
But I don't see how it relates to alpha and prong one, which is

[00:01:53] Speaker 02:
your burden at prong one to establish that there is some kind of medical or scientific probable theory that

[00:02:07] Speaker 02:
that this vaccine could cause this particular injury.

[00:02:11] Speaker 02:
Is that correct to say that this infectious disease expert wouldn't really help do anything to support and further your case for this mimicry idea?

[00:02:25] Speaker 03:
Well, it's correct to say that the infectious disease expert would not offer affirmative testimony about Prong One.

[00:02:38] Speaker 03:
of the relative strength of the theories and the court focused on the infectious disease.

[00:02:45] Speaker 03:
By the way, there was no mechanism for the infectious disease other than molecular mammary, which is the primary way we understand that molecular mammary plays a role.

[00:02:56] Speaker 02:
I guess what I'm trying to understand is how would this addition

[00:03:00] Speaker 02:
additional expert help you with health and problems in terms of the intern more likely than i would like of the your proposed expert would not have uh... further supported your case on molecular mimicry is that right no and we wouldn't have a lot on on that expert for that purpose it was right and so i guess mike and i'm trying to figure out uh... what what uh...

[00:03:26] Speaker 02:
How does this actually help the case?

[00:03:29] Speaker 02:
Because even if it's relevant to Alton Prong 2, it wouldn't do anything to help your cause on Alton Prong 1, which the special master and then affirmed by the claims court concluded that you had not sufficiently made your case for.

[00:03:44] Speaker 03:
Well, we don't agree that it wouldn't have helped us on Prong 1, even though it's not direct.

[00:03:50] Speaker 03:
Because there's a relative strength issue of what you're focusing on.

[00:03:56] Speaker 03:
the special master found it was indisputable that infectious disease played a role.

[00:04:01] Speaker 03:
And didn't have a full discussion of prong one, probably because he didn't feel it was necessary.

[00:04:07] Speaker 03:
However, if you weigh the relative strength and the mechanism of our theory, infectious disease expert would place that into context.

[00:04:16] Speaker 03:
So even though it wasn't going to be direct, there was still relevant testimony to be offered.

[00:04:26] Speaker 03:
government decision wants to do is silo prong one and separate it from the other prongs.

[00:04:32] Speaker 03:
And the case law is clear that you can consider evidence of other prongs that inform the relative strength of prong one.

[00:04:42] Speaker 03:
And whether it was more likely or not, that theory was the more likely theory, or a theory that was plausible and met the standard of proof.

[00:04:52] Speaker 03:
So in that way, our presentation

[00:04:56] Speaker 03:
infectious disease expert would be relevant to that.

[00:04:59] Speaker 03:
In addition, the court relied heavily on biostatistics and epidemiology for rejecting our pronged law and evidence.

[00:05:09] Speaker 03:
And we moved for permission to present the testimony of an epidemiologist or biostatistician.

[00:05:18] Speaker 03:
It was rejected, summarily.

[00:05:20] Speaker 03:
So that would go directly to the interest because the court relied

[00:05:25] Speaker 03:
on the biostatistics for rejecting our Prong 1 theory and criticize... Sir, how common is it for the switching causation theories to happen several years into a given case?

[00:05:39] Speaker 03:
I'm sorry, sir.

[00:05:40] Speaker 00:
How common is it in cases that you've seen for there to be a switch in the causation theory several years into a case?

[00:05:48] Speaker 03:
So we switched, and I think Your Honor's referring to our initial theory was predicated primarily on aluminum as an adjuvant.

[00:05:58] Speaker 03:
And then Dr. Steinman offered an expert report.

[00:06:02] Speaker 03:
How common?

[00:06:04] Speaker 03:
Probably not that common, but it does happen.

[00:06:07] Speaker 03:
Because you can present alternate theories.

[00:06:10] Speaker 03:
You can present multiple theories.

[00:06:12] Speaker 03:
These are not necessarily theories that are definite in science.

[00:06:17] Speaker 03:
And the case law says, the Court of Appeals says, that this field is bereft of knowledge of exactly how vaccines affect the human body.

[00:06:27] Speaker 00:
So what was your best argument for why there would be an abuse of discretion in terms of not allowing you to get these additional experts?

[00:06:35] Speaker 03:
The best argument for why there's abuse of discretion would be that the petitioner was not presented a full and fair opportunity to present his case.

[00:06:47] Speaker 02:
But you had multiple years to put on a case, and you had your expert file many expert reports during that time.

[00:06:59] Speaker 02:
information on hand about the respiratory infection that you could have years earlier responded to.

[00:07:08] Speaker 02:
And so I think that seemed to be what was driving the special master to conclude that you were on notice about the respiratory infection idea and you waited too late.

[00:07:21] Speaker 02:
So I guess what I'm trying to figure out is why is that an unreasonable conclusion?

[00:07:25] Speaker 03:
Fair.

[00:07:26] Speaker 03:
I appreciate the question.

[00:07:28] Speaker 03:
First of all, the special master and his decision, I don't think, and we presented this in our brief, appreciated the record.

[00:07:37] Speaker 03:
He said that we made an 11th hour request to present our additional experts.

[00:07:43] Speaker 03:
We made that request two years earlier, well before the decision or when it was transferred to the chief special master in 2020, March of 2020.

[00:07:57] Speaker 03:
We first raised that issue.

[00:07:59] Speaker 03:
We made a formal motion in May 2020.

[00:08:01] Speaker 03:
It was a year and a half later it was transferred, and two years later we have a decision.

[00:08:07] Speaker 03:
So I would submit that we were not late in the process.

[00:08:11] Speaker 02:
Yes, the idea was by the time you requested this in 2020, the case had been already going on since 2016.

[00:08:19] Speaker 02:
The government filed its 4C report in 2017, and so therefore you had

[00:08:26] Speaker 02:
three years and marching through that whole time with other expert reports being filed, there was plenty of time, it seems like, in that interim space to have tried to switch horses, so to speak, and move on to this.

[00:08:46] Speaker 03:
Two points in response to that question.

[00:08:49] Speaker 03:
I appreciate the question.

[00:08:52] Speaker 03:
One is Dr. Steinman did address the issue.

[00:08:56] Speaker 03:
But it became increasingly apparent that Dr. Steinman, in addressing that issue, may, as I mentioned earlier, go beyond the scope of his expertise because it's not an infectious disease.

[00:09:10] Speaker 03:
And there came a point where Dr. Collins, who is an expert in infectious disease, emphasized her point two or three times.

[00:09:20] Speaker 03:
At that point, it became clear we would need, and it was not necessarily late in the process,

[00:09:26] Speaker 03:
It was in the middle of the process.

[00:09:28] Speaker 03:
And I don't think there was any forfeiture of an opportunity to present that evidence when it became clear, and as it was established, that the chief special master would criticize Dr. Steinman, the neurologist, for testifying outside the scope of his expertise.

[00:09:50] Speaker 03:
So we decided it was important

[00:09:53] Speaker 03:
to present our experts at that point.

[00:09:55] Speaker 03:
But it was not late in the process.

[00:09:57] Speaker 03:
It was in the middle of the process.

[00:09:58] Speaker 03:
We still filed additional expert reports after we made the application to present the expert in infectious disease and biostatistics.

[00:10:08] Speaker 03:
So should we have done it earlier?

[00:10:11] Speaker 03:
I think in retrospect, yes.

[00:10:15] Speaker 03:
And in any case like this in the future, we'll do that right at the outset.

[00:10:20] Speaker 03:
We're relying on Dr. Steinman, who is an esteemed neurologist.

[00:10:25] Speaker 03:
But if the court is going to reject his presentation on that issue, which it did in the decision, we want an opportunity, a full and fair opportunity, to address the issues head on.

[00:10:40] Speaker 03:
So I would submit it wasn't late.

[00:10:42] Speaker 03:
It was in time.

[00:10:44] Speaker 03:
It was not at the outset, not right after the 4C, but when it became apparent

[00:10:50] Speaker 03:
that Dr. Steinman's presentation was not going to be accepted on that specific aspect, which then appeared, as it occurred in the decision, to be the primary issue in the case.

[00:11:06] Speaker 02:
OK.

[00:11:06] Speaker 02:
Why don't we save the remainder of the report?

[00:11:08] Speaker 02:
Thank you.

[00:11:09] Speaker 02:
Let's hear from the government.

[00:11:13] Speaker 01:
Thank you, Your Honors.

[00:11:13] Speaker 01:
Good morning.

[00:11:14] Speaker 01:
May it please the court?

[00:11:15] Speaker 01:
My name is Nina Ren, and I represent Respondent Appellee, the Secretary of Health and Human Services.

[00:11:21] Speaker 01:
The chief special master below made separate findings under each of the Eltham prongs.

[00:11:26] Speaker 01:
So the entitlement decision below did not rest only on epidemiology, and a biostatistician would not have advanced petitioner's cause.

[00:11:35] Speaker 01:
Nor did the entitlement decision rely on the presence of an influenza-like illness, and thus an infectious disease specialist would have made no difference in the ultimate outcome of the case.

[00:11:45] Speaker 01:
Under Eltham 1, the chief special master denied entitlement because petitioner failed

[00:11:50] Speaker 01:
present a causation theory that rose beyond a theoretical possibility.

[00:11:55] Speaker 01:
The chief special master found that Dr. Simon never produced any reliable evidence to overcome the fatal flaw in his molecular mimicry theory, namely that even if we accept molecular mimicry as a general theory, homology, no matter how many times you filter it through, is necessary but not sufficient to cause actual disease.

[00:12:16] Speaker 01:
And in his decision,

[00:12:17] Speaker 01:
He cites to Dr. Simon's report, and that Dr. Simon himself recognizes the flaw in his theory.

[00:12:26] Speaker 01:
There's another reason why biostatistician is unnecessary in this case.

[00:12:31] Speaker 01:
As the Chief Special Master stated, he was already familiar with the two primary studies at issue, Baxter 1 and Baxter 2.

[00:12:39] Speaker 01:
because they are frequently presented in the vaccine program.

[00:12:43] Speaker 01:
He simply didn't need additional specialists to understand the epidemiology presented in this particular case.

[00:12:50] Speaker 01:
Moreover, Patricia's own expert, Dr. Simon, wrote in his first report that he had relevant experience qualifying him to address

[00:12:59] Speaker 01:
epidemiology and that he had actually gained some deep insights on how difficult it was to do proper epidemiologic studies.

[00:13:07] Speaker 01:
So Dr. Steinman put himself forward as someone who was qualified to opine and biostatistics and in fact did do so.

[00:13:18] Speaker 02:
So if the special master was fine with allowing Dr. Steinman to opine on all these things, why did it

[00:13:29] Speaker 02:
why did the Special Master prevent an additional expert from opining on these very same things?

[00:13:36] Speaker 01:
Because it wouldn't have made a difference.

[00:13:38] Speaker 01:
And I think it was within the Chief Special Master's purview as a fact-finder in the case to oversee litigation and decide when it is time to move forward.

[00:13:50] Speaker 02:
I'm just trying to figure out would there have been additional delay in entertaining a second expert on

[00:13:58] Speaker 02:
the petitioners side, compared to just confining things to Dr. Steinman?

[00:14:03] Speaker 01:
There would have been additional delay.

[00:14:05] Speaker 01:
In terms of the biostatistician, based on what petitioners argued, they would have retained another, a new expert.

[00:14:14] Speaker 01:
there is sort of an unknown quantity of time that would take for that expert to become acquainted with the entire record in the case, to render his or her opinion, and then respond and would then have the opportunity to respond and retain a biostatistician ourselves, because our expert, Dr. Collins, also wasn't an epidemiologist.

[00:14:36] Speaker 01:
So that would have added even further time, and the case has already been lingering for quite some time.

[00:14:43] Speaker 00:
Opposing counsel contends that they didn't wait too late.

[00:14:47] Speaker 00:
It wasn't an 11-hour request.

[00:14:48] Speaker 00:
It was done as soon as they could.

[00:14:50] Speaker 00:
How do you respond to that?

[00:14:53] Speaker 01:
I would disagree.

[00:14:53] Speaker 01:
As this court has noted, Respondent had already issued our Rule 4C report where we sort of laid out our objections and what we felt were issues precluding Petitioner from entitlement in this case.

[00:15:11] Speaker 01:
We had cited to the medical records that Patricia had himself filed, showing the language from treating providers that the respiratory infection was something that they were thinking about in terms of having a causal connection with Patricia's GBS.

[00:15:25] Speaker 01:
And Petitioner's petition itself, the one that he filed in August 2016, raised the issue of that infection as one of the allegations that he made in the petition.

[00:15:35] Speaker 01:
So all this information, including when we filed Dr. Collins' first report and her CV by December 2017, Petitioner had

[00:15:45] Speaker 01:
all the notice they needed, more notice than they needed to inform their litigation strategy.

[00:15:52] Speaker 01:
And they could have retained an infectious disease specialist if that's how they wanted to proceed.

[00:15:59] Speaker 01:
And they didn't.

[00:16:00] Speaker 01:
They chose to proceed with Dr. Simon, and they chose to present additional reports from him.

[00:16:09] Speaker 01:
I also want to address the point that petitioners council made regarding the time it took between shifting from the initial special master in the case to the chief special master.

[00:16:21] Speaker 01:
And I think looking at the docket from that time frame, that was the period when the parties agreed to attempt an informal resolution of the case.

[00:16:31] Speaker 01:
And from the docket entries, I think it's clear that Respondent was weighting a demand from Petitioner.

[00:16:38] Speaker 01:
And after a certain number of status reports from Petitioner indicating that the demand had not yet been proffered, the case was reassigned to the Chief Special Master, who then determined at that time that a ruling of the record was appropriate.

[00:17:04] Speaker 01:
I think another point I just wanted to highlight is that it is evident in Patricia's motion for leave, which was duplicated in the brief before us today that

[00:17:17] Speaker 01:
The intent of the additional specialists, the additional new experts, was to re-argue the case.

[00:17:24] Speaker 01:
I think as Patricia's counsel sort of noted earlier in his opening that Dr. Collises had emphasized her opinion several times already, and at that point they wanted to bring in someone else to address her comments.

[00:17:40] Speaker 01:
And that is not the intent of the full and fair opportunity.

[00:17:45] Speaker 01:
It's not to allow re-argument of evidence to give you unlimited opportunity to present your case.

[00:17:53] Speaker 01:
And I think the Chief Special Master acted within his purview.

[00:17:57] Speaker 01:
He didn't abuse his discretion when he elected to proceed with a ruling on the record.

[00:18:03] Speaker 01:
If there are no other questions, I will close by saying the special masters below reasonably concluded that it was not necessary to add new experts to this late in the process.

[00:18:12] Speaker 01:
The special masters appropriately acted within their discretion and the chief special master appropriately denied entitlement.

[00:18:18] Speaker 01:
A respondent respectfully requests that this court affirm the claims court's judgment dismissing the petition.

[00:18:24] Speaker 01:
Thank you very much.

[00:18:26] Speaker 02:
Okay, thank you.

[00:18:31] Speaker 03:
On rebuttal, I have three main points.

[00:18:33] Speaker 03:
First of all, if the chief special master felt he already had sufficient knowledge about epidemiology to judge this case, he prejudged the case, which is why we wanted an opportunity to present our biostatistician.

[00:18:53] Speaker 03:
That's number one.

[00:18:53] Speaker 03:
Number two is there would have been no delay whatsoever.

[00:18:57] Speaker 03:
We still had a year.

[00:18:58] Speaker 03:
We had other expert reports that were filed

[00:19:01] Speaker 03:
We didn't have to wait for those expert reports to file the expert reports of our infectious disease expert or our epidemiologist.

[00:19:09] Speaker 03:
It would be done simultaneously.

[00:19:11] Speaker 03:
And we made the motion.

[00:19:12] Speaker 03:
We were ready to go.

[00:19:14] Speaker 03:
We were simply denied the opportunity to do it.

[00:19:16] Speaker 03:
So there would have been no additional delay.

[00:19:18] Speaker 03:
Thirdly, we weren't offering to re-argue points.

[00:19:22] Speaker 03:
We were offering to argue points from the perspective of a new expert

[00:19:27] Speaker 03:
with expertise in the particular domains that were raised.

[00:19:31] Speaker 03:
So that's not re-arguing.

[00:19:33] Speaker 03:
Dr. Steinman presented his view of those issues as a neurologist.

[00:19:39] Speaker 03:
We wanted to present it from the point of view of an infectious disease expert and an epidemiologist, because it became apparent and proved to be true that those were the two main focuses of the chief special master.

[00:19:55] Speaker 03:
And so we were denied a full and fair opportunity to present that evidence.

[00:20:00] Speaker 03:
It wasn't re-argument evidence.

[00:20:01] Speaker 03:
It wasn't cumulative evidence.

[00:20:03] Speaker 03:
It was new evidence that we offered to present.

[00:20:07] Speaker 03:
And we were summarily denied without an explanation.

[00:20:10] Speaker 03:
So for those reasons, Your Honor, I believe the petitioner, the vaccine-injured petitioner, was denied a full and fair opportunity to meet his burden of proof.

[00:20:19] Speaker 03:
And this court has recently said that's the petitioner.

[00:20:22] Speaker 03:
In the Winkler case, the petitioner has the burden of proof.

[00:20:26] Speaker 03:
We were trying to meet our burden of proof.

[00:20:28] Speaker 03:
We should have been given an opportunity to do that, and we were denied.

[00:20:32] Speaker 03:
Thank you.

[00:20:33] Speaker 03:
Unless there are further questions.

[00:20:34] Speaker 03:
Thank you, Mr. Krakow.

[00:20:35] Speaker 03:
The case is submitted, and that concludes today's arguments.