[00:00:00] Speaker 03:
Next case is Donald Winkler versus the Secretary of HHS, 2022, 1960.

[00:00:10] Speaker 03:
Mr. Milmo, when you're ready.

[00:00:12] Speaker 00:
May it please the court, Michael Milmo for Donald Winkler petitioner in this case.

[00:00:18] Speaker 00:
Good morning, Your Honors.

[00:00:18] Speaker 00:
I don't think this is an exceptionally complicated case, but it may be a close case as to prong two of the Altham test.

[00:00:28] Speaker 00:
I would just remind the court up front of this court's mandatory language from the Alton case that says close cases are supposed to be resolved in favor of petitioner.

[00:00:40] Speaker 00:
I say it's not a complicated case because it involves really just one issue.

[00:00:46] Speaker 00:
Can a special master examine the case through the prism of C. de Juny infection and not find

[00:00:57] Speaker 00:
that the petitioner actually suffered from that particular infection.

[00:01:02] Speaker 03:
But isn't the issue whether there is preponderant evidence that his injury was caused by the vaccines?

[00:01:14] Speaker 00:
I'm sorry, is there preponderant evidence?

[00:01:16] Speaker 03:
That the injury was caused by the vaccines.

[00:01:20] Speaker 00:
I think that Dr. Ricker provided substantial evidence that the

[00:01:27] Speaker 00:
vaccine and issues here caused his GBS.

[00:01:32] Speaker 00:
And the special master rejected that evidence based strictly on her assumption, if you will, that Campylobacter can be associated with cases of GBS.

[00:01:49] Speaker 00:
Mr. Winkler had diarrhea.

[00:01:50] Speaker 00:
He had a very nonspecific form of pre-existing

[00:01:57] Speaker 00:
damage here.

[00:01:58] Speaker 00:
There are all kinds of reasons for diarrhea.

[00:02:00] Speaker 00:
I mean, I'm sure that half the people in this room have probably had diarrhea at some point in the last few months.

[00:02:06] Speaker 03:
We won't get into that.

[00:02:07] Speaker 00:
Yeah, thank you.

[00:02:09] Speaker 00:
But, you know, if the respondent cannot prove that the particular cause of the diarrhea and the vomiting was C. jejuni infection, then the entire analysis of the special master has to change.

[00:02:27] Speaker 00:
I mean, the fact that even Dr. Chaudhary, I think this is an important point on page 98 of the transcript, even Dr. Chaudhary says that antigen antibodies are specific.

[00:02:45] Speaker 00:
Diarrheal illnesses from C. jejuni infection that triggers GBS cannot be equated with diarrheal illness from another gut infection where other species of Campylobacter such as Campylobacter coli

[00:02:57] Speaker 00:
The latter does not trigger GBS.

[00:03:00] Speaker 03:
So what you're saying is that the inadequacy of the analysis with respect to an alternative cause enables him to prevail even though he hasn't proved by preponderance of the evidence that the vaccine caused GBS.

[00:03:21] Speaker 00:
Well, I think the special master inappropriately

[00:03:25] Speaker 00:
used Campylobacter, which she didn't make any finding on as to whether he had it, in order to knock down Dr. Rinker's testimony concerning what was more likely.

[00:03:37] Speaker 00:
She fault him for not being able to provide evidence, but he did provide evidence, saying, hey, timing is important to me.

[00:03:45] Speaker 00:
Timing is important to my opinion.

[00:03:47] Speaker 00:
And then on page 32 of her decision,

[00:03:49] Speaker 00:
She says, Dr. Rinker attempted to argue that the temporal association between the vaccination and GBS onset favored the vaccines as the more likely cause.

[00:03:58] Speaker 00:
However, literature cited by Dr. Rinker notes that an incubation period with campylobacter infections consisted with Dr. Witten's opinion and the literature cited by Dr. Witten and Chaudhry.

[00:04:10] Speaker 00:
Taking into account the incubation period between infection and symptoms, onset would place the infection

[00:04:17] Speaker 00:
before or approximately the same date.

[00:04:19] Speaker 00:
So she knocked out his timing argument based on Campelobacter, which she never found that he actually had.

[00:04:27] Speaker 00:
I mean, the fact that her analysis revolves and incorporates the analysis of Campelobacter is very strong.

[00:04:41] Speaker 00:
I counted in the decision.

[00:04:43] Speaker 00:
84 places where she either used the term Campylobacter or C. jejuni infection.

[00:04:49] Speaker 00:
Secondly, she wants the reviewing court to know, because she must know that this case is a fairly close case, that there are only two terms, two medical terms that she wanted to define for the reviewing court.

[00:05:03] Speaker 00:
One was Guillain-Barre syndrome, which is what Mr. Winkler had.

[00:05:06] Speaker 00:
And the second is Campylobacter.

[00:05:09] Speaker 00:
I think if you look at the third,

[00:05:12] Speaker 00:
piece of evidence that I would point you to or invite you to look at is her decision on pages 26 and 27 of the appendix where she talks about Dr. Chaudhary, that's the respondent's expert, opinion as two prong two.

[00:05:27] Speaker 00:
The entire portion of Dr. Chaudhary's opinion deals with Campylobacter.

[00:05:36] Speaker 00:
If Mr. Winkler didn't have Campylobacter,

[00:05:39] Speaker 00:
I think the respondent's arguments necessarily have to fold, and so does the analysis of the special master.

[00:05:46] Speaker 00:
But we don't know whether he had campylobacter effector or not, because she never made that finding.

[00:05:51] Speaker 00:
And I think that's legal error for her not to do that.

[00:05:55] Speaker 03:
Doesn't that just mean that an alternative cause was not proven?

[00:06:00] Speaker 00:
An alternative cause

[00:06:02] Speaker 00:
can't be proven in this case, nor can it be excluded in this case.

[00:06:06] Speaker 00:
The special master uses as a sword against Mr. Winkler the idea that no testing was done.

[00:06:14] Speaker 00:
Well, that's also a sword against the respondent's position, because Dr. Chaudhuri can't prove that the Campylobacter existed because no testing was done.

[00:06:27] Speaker 00:
But yet, she only implies and enforces that

[00:06:31] Speaker 00:
that rule against the petitioner.

[00:06:33] Speaker 03:
That's not the government's burden of proof, is it?

[00:06:36] Speaker 00:
Well, that's not entirely clear.

[00:06:38] Speaker 00:
I want to point that the court, invite the court's attention again to what I think is, besides Dr. Chaudhary's discussion on page 98, I think the other most important part of this appendix is the special master's rule five order, which is that

[00:07:00] Speaker 00:
Appendix 103 and 104.

[00:07:03] Speaker 00:
It's a pretty short order, but she discussed the case at length with counsel as part of the Rule 5.

[00:07:10] Speaker 00:
As you probably know, Rule 5 is the part of the vaccine program where the special masters give you their impressions of the case after the expert reports are in and after the parties have established their positions.

[00:07:22] Speaker 00:
She says right at the bottom, because there are three potential causes in this case, and based on the medical evidence,

[00:07:28] Speaker 00:
The undersigned finds it difficult, if not impossible, to discern which cause is most likely.

[00:07:35] Speaker 00:
The undersigned instructed the parties to look at Goring.

[00:07:38] Speaker 00:
Goring is a case that she herself decided, the same special master decided, in which she said that it's not entirely clear who has the burden of proof.

[00:07:46] Speaker 00:
When there are multiple cases, she looked at restatement second of torts, which is the same case, I might add, that the same place

[00:07:56] Speaker 00:
that this court's whole line of causation cases under shy face comes from is the restatement second.

[00:08:03] Speaker 00:
And she says that the respondent has the responsibility of distinguishing.

[00:08:07] Speaker 00:
When there are multiple causes, it's the tortfeasor who has the responsibility, the respondent, to prove what is more likely.

[00:08:14] Speaker 00:
I would just ask the court to define what changed between her

[00:08:23] Speaker 00:
Rule 5 order of April 2, and her decision in the case in the following year.

[00:08:31] Speaker 00:
And I think what changed is she kind of put her thumb on the scale of Campylobacter.

[00:08:37] Speaker 00:
That would explain everything.

[00:08:39] Speaker 00:
But with all due respect, she adopted Dr. Chaudry's analysis.

[00:08:47] Speaker 00:
But Dr. Chaudry's analysis is

[00:08:48] Speaker 00:
is not very scientific.

[00:08:52] Speaker 00:
We know that he has GBS, and we know that he has diarrhea, and we know that campylobacter can be a cause of diarrhea, one of many causes of diarrhea, and that campylobacter can be associated with GBS.

[00:09:09] Speaker 00:
Therefore, he must have had campylobacter.

[00:09:13] Speaker 00:
And the analysis from the special master

[00:09:16] Speaker 00:
is really clear on page 32.

[00:09:18] Speaker 00:
Again, she completely knocks out the petitioner's argument by saying, but by applying a lens of Campbell of actor, but never finding that he had Campbell of actor.

[00:09:40] Speaker 02:
I think it's just the inverse of that.

[00:09:54] Speaker 00:
I think she's saying that we can't prove Prong 2 because we can't prove he didn't have Campylobacter.

[00:10:03] Speaker 00:
uh... and capable of actor is something that neither side can prove because it was not never tested for and if it was so important to her decision i would just say that but she needed to make a finding i don't think we'd be here today frankly your honor if if uh... she included two or three paragraphs about i find that he had capital of actor he didn't have capital of actor you help me other government sites in its brief that w c case of ours

[00:10:31] Speaker 02:
Which says, according to them, merely demonstrating a plausible or possible causal link is insufficient to meet your preponderance of the evidence standard in this context.

[00:10:42] Speaker 02:
You didn't respond to that in your grave brief.

[00:10:44] Speaker 02:
What's the response?

[00:10:45] Speaker 00:
Well, I think the response is that the special master necessarily conflated Campola Bacter and he used that to discredit the petitioner's case.

[00:11:01] Speaker 00:
I mean,

[00:11:01] Speaker 00:
We have Prom 1.

[00:11:03] Speaker 00:
We have Prom 3.

[00:11:05] Speaker 00:
And on Prom 2, again, neither the special master nor Dr. Chaudhary showed their work.

[00:11:15] Speaker 00:
It's just an analysis that this must be the case without any specific findings.

[00:11:22] Speaker 00:
And I might just add,

[00:11:23] Speaker 00:
Dr. Chauvery's opinion about the presence of Campylobacter was hotly contested.

[00:11:28] Speaker 00:
It's virtually impossible to decide this case without making a finding one way or the other.

[00:11:34] Speaker 00:
I think the answer to your question is you can't just raise what's possible.

[00:11:41] Speaker 00:
That's true.

[00:11:42] Speaker 00:
But you can't also knock out the petitioner's evidence of what's possible using something that you don't know whether Mr. Winkler had in the first place or not.

[00:11:53] Speaker 03:
Counsel, you're into your rebuttal time.

[00:11:55] Speaker 00:
OK, I'll reserve the rest of my time.

[00:11:56] Speaker 00:
Thank you, Your Honor.

[00:11:57] Speaker 03:
That'll be fine.

[00:12:00] Speaker 03:
Please, Ren.

[00:12:07] Speaker 01:
Good morning, Your Honors.

[00:12:08] Speaker 01:
May it please the court.

[00:12:09] Speaker 01:
My name is Nina Ren, and I represent the Respondent and Secretary of Health and Human Services.

[00:12:15] Speaker 01:
This isn't a closed case.

[00:12:17] Speaker 01:
A petitioner disagrees with a special master's weighing all the evidence

[00:12:21] Speaker 01:
and her holding Petitioner accountable to his burden of explaining why the specific circumstances of his case more likely than not aligned with the scientific explanations that he provided.

[00:12:33] Speaker 01:
Petitioner is asking this court to embargo evidence that he himself introduced in direct conflict with this court's holding in stone.

[00:12:41] Speaker 01:
Petitioner cannot fault the Special Master or the Court of Federal Claims for considering arguments advanced by their own expert,

[00:12:47] Speaker 01:
Dr. Rinker, who conceded that he could not distinguish between vaccination or the diarrheal illness alone was responsible for Petitioner's GBS.

[00:12:56] Speaker 01:
And he himself introduced evidence on CJ Junie's association with GBS.

[00:13:05] Speaker 01:
And although Dr. Rinker ultimately disagreed that CJ Junie was the responsible pathogen, the special master considered both sides and relied on the whole record, as she was required to do,

[00:13:16] Speaker 01:
And she correctly determined that the petitioner ultimately never produced enough evidence for a primary affection case.

[00:13:23] Speaker 01:
And I'd just like to address a couple points made by Petitioner's Counsel, a different oral argument.

[00:13:29] Speaker 01:
Much of, I think, the points that Petitioner's Counsel raised goes back to how the special master weighed the evidence between these

[00:13:42] Speaker 01:
between Patricia's expert and respondent's experts.

[00:13:46] Speaker 01:
And I think it's clear looking at the expert reports and looking at how Special Master below reviewed the evidence that although CJJUNI was used by both Patricia's counsel, Patricia's expert, and referenced by Dr. Whitten, respondent's expert, and Dr. Chaudhry,

[00:14:08] Speaker 01:
All the experts at the end of the day agreed that gastrointestinal infection is scientifically associated with GBS.

[00:14:18] Speaker 01:
It does not have to be CGGNI, and some of the articles they cite show the various other pathogens that have been connected with GBS as well.

[00:14:28] Speaker 01:
So both sides agreed that GI is sort of the elephant

[00:14:37] Speaker 01:
in the room in this case.

[00:14:39] Speaker 01:
And the special master correctly determined that Patricia's counsel just didn't adequately account for it when making their case.

[00:14:50] Speaker 01:
With respect to the reference to the rule five order, the vaccine rules makes it very clear that there are tentative preliminary findings.

[00:15:00] Speaker 01:
So they're tentative, they're preliminary.

[00:15:02] Speaker 01:
She was not bound to them, just as she was not bound to her decision that she referenced scoring, which is a ruling on entitlement that she issued.

[00:15:11] Speaker 01:
It's not binding on her, it's non-precedential.

[00:15:15] Speaker 01:
She had no obligation to write her decision the same way that her tentative findings came out.

[00:15:27] Speaker 04:
I think if there are no... You know, it looks to me like Winkler made a strong prima facie case and the government did not come back and counter it.

[00:15:42] Speaker 04:
And the master, special master didn't make a finding on the CG, CJ.

[00:15:49] Speaker 04:
So why isn't that the end of the case?

[00:15:51] Speaker 04:
They were asking for it to go back for a remand to be done.

[00:15:54] Speaker 04:
Why isn't it that the government loses in this case?

[00:16:00] Speaker 04:
Why would they get it blew over?

[00:16:02] Speaker 01:
I would disagree that petitioners council made a permanent fashion case under, for example, Elton 1.

[00:16:14] Speaker 04:
Let's assume.

[00:16:15] Speaker 04:
I mean, I believe they did.

[00:16:16] Speaker 04:
And I understand your argument.

[00:16:19] Speaker 04:
So my question is, why isn't that the end of the case, as opposed to having to go back

[00:16:23] Speaker 04:
give the government another shot at it.

[00:16:27] Speaker 01:
I don't think it's necessary for it to go back on remand because whether or not the special master, the special master below Dorsey made a fact finding on the presence of Sita Juni as the pathogen, it doesn't take care of the issue of the fact that Petitioner had.

[00:16:53] Speaker 01:
a clinical presentation that was very similar to a clinical presentation of a GI infection, such that his treating provider, Dr. White, noted that it was a classic presentation with his symptoms and GBS.

[00:17:13] Speaker 01:
And I think the characterization of what happened to Partitioner as diarrhea that could have happened to anyone,

[00:17:22] Speaker 01:
happens all the time is inaccurate in this case because that was not the only symptom.

[00:17:27] Speaker 01:
It was this constellation of symptoms that concerned his treating providers and also concerned

[00:17:36] Speaker 01:
respondents experts.

[00:17:38] Speaker 01:
And that included nausea, vomiting, bloody stools, headaches.

[00:17:44] Speaker 01:
There was a whole range of symptoms at play here.

[00:17:48] Speaker 01:
So even if the Special Master made a fact finding on seizure journey, I mean, if she said it was indeed seizure journey, I think the case would have been over for a petitioner.

[00:18:00] Speaker 01:
If she said, I don't think it was seizure journey,

[00:18:04] Speaker 01:
the record evidence is so clear that there was nevertheless this GI infection.

[00:18:09] Speaker 01:
And that is still sufficient for her to find that a petitioner do not satisfy the preponderance of the evidence standard in meeting their case.

[00:18:21] Speaker 02:
So I want to make sure I understood that answer to Judge Amer's question.

[00:18:24] Speaker 02:
I understood him to be saying, if we find that there was a prima facie case,

[00:18:30] Speaker 02:
The options at that point are either the government loses and we reverse, or we send it back for further proceedings.

[00:18:37] Speaker 02:
You said no need to remand.

[00:18:39] Speaker 02:
Does that mean we should reverse if we find there was a prima facie case?

[00:18:43] Speaker 01:
If you do find in this case that they did satisfy their prima facie burden, then I think then we will look at the evidence under the factor unrelated.

[00:19:02] Speaker 02:
You would have a chance to rebut in the ordinary course, right?

[00:19:06] Speaker 02:
Correct, yes.

[00:19:07] Speaker 02:
So are you asking for that chance if that's the decision we reach or should we just end the case if we find they found a prima facie case?

[00:19:15] Speaker 01:
I think if you find that, if your owners find that they did satisfy their prima facie case, then yes, respondent I think would have the legal right to.

[00:19:27] Speaker 01:
to put forward the alternate cause factors unrelated argument.

[00:19:31] Speaker 01:
So we would be asking for a remand.

[00:19:34] Speaker 04:
Why was that done in the first place?

[00:19:37] Speaker 01:
I think the evidence was produced.

[00:19:41] Speaker 01:
I think the case law doesn't necessarily require you to categorize evidence in these strict boxes, and that they can be considered as part of petitioners' ability to make the prima facie case, which in their case, they were the ones who made the attempt to eliminate this, to say that it wasn't Cesar Giugini.

[00:20:10] Speaker 01:
And then also, we could use that evidence as if factors are related to them.

[00:20:15] Speaker 03:
Is a prima facie case a preponderance?

[00:20:19] Speaker 03:
Yes, it is, Your Honor.

[00:20:22] Speaker 02:
Can I ask you just about jurisdiction?

[00:20:24] Speaker 02:
You have this footnote for page 80, your brief, which suggests that the notice of appeal was late, but doesn't come right out and say it was late.

[00:20:33] Speaker 02:
And you never say we lack jurisdiction.

[00:20:35] Speaker 02:
So what is the government's view?

[00:20:37] Speaker 02:
Do we have jurisdiction or not?

[00:20:40] Speaker 01:
Our position is that we defer to the court on this answer.

[00:20:44] Speaker 02:
You defer to the court?

[00:20:46] Speaker 01:
Defer to the court.

[00:20:47] Speaker 01:
I don't believe I have authority to make any further arguments on that.

[00:20:53] Speaker 02:
It's clear that you did not argue expressly that we lack jurisdiction.

[00:20:57] Speaker 02:
Is that fair?

[00:20:57] Speaker 01:
That's fair.

[00:21:03] Speaker 01:
If there are no further questions,

[00:21:06] Speaker 01:
I would just ask that the court affirm the decisions below of the Special Master and the Court of Federal Claims.

[00:21:12] Speaker 01:
Thank you.

[00:21:12] Speaker 03:
Thank you, Ms.

[00:21:13] Speaker 03:
Wren.

[00:21:13] Speaker 03:
Mr. Milmo.

[00:21:22] Speaker 00:
Thank you, Your Honors.

[00:21:24] Speaker 00:
Again, on the issue of the diarrhea, diarrhea has a lot of causes.

[00:21:29] Speaker 00:
Dr. Rinker specifically talks about

[00:21:33] Speaker 00:
The most common form of diarrhea is caused by eating something bad or drinking something that's tainted.

[00:21:43] Speaker 00:
For the respondent's expert in the court to extrapolate from that, that because he has GBS and diarrhea, then it has to be Campylobacter, that's not appropriate, especially without making the finding.

[00:21:59] Speaker 00:
Again, if there had been a finding here one way or the other,

[00:22:02] Speaker 00:
that said, for the following reasons, I find that the person that Mr. Winkler had or didn't have a campylobacter infection, that would have ended the case.

[00:22:14] Speaker 00:
One way or the other, we would have known.

[00:22:17] Speaker 04:
Did the government give the master sufficient grounds to make that finding?

[00:22:22] Speaker 00:
Did the petitioner give the government?

[00:22:29] Speaker 00:
I don't think so, because it's based on speculation.

[00:22:34] Speaker 00:
It's based on that kind of backwards syllogism that if you have the answer, then you can show your work below.

[00:22:44] Speaker 00:
And that's not appropriate.

[00:22:46] Speaker 00:
So I don't think the government gave the special master what she needed to make that finding.

[00:22:54] Speaker 04:
So if they didn't give it to her and she didn't find it,

[00:22:58] Speaker 04:
Why isn't that the end of the case in your favor?

[00:23:01] Speaker 00:
It could be, and if the court wants to find that, that's just fine.

[00:23:04] Speaker 04:
You asked for a remand.

[00:23:08] Speaker 04:
What is your position on a remand?

[00:23:10] Speaker 00:
We wish we had had a hearing in this case.

[00:23:14] Speaker 00:
I just want to explain that very briefly.

[00:23:15] Speaker 00:
The reason we didn't have a hearing is because after this Rule 5 conference, the court told us to

[00:23:20] Speaker 00:
try to settle the case, which we couldn't do.

[00:23:23] Speaker 00:
The government wasn't interested in settling the case.

[00:23:25] Speaker 00:
They wanted to move forward.

[00:23:27] Speaker 00:
And the courts issued an order saying, in June of 2020, saying, in 2021, I'll take under consideration hearing dates for 2022 at the earliest.

[00:23:39] Speaker 00:
We didn't do that.

[00:23:40] Speaker 00:
I think a hearing having Dr. Chaudhary and Dr. Rinker discuss the two issues that are at the heart of this case

[00:23:49] Speaker 00:
Did Mr. Winkler have Campylobacter and what subtype did he suffer from, one which is not consistent with Campylobacter and one that is?

[00:24:03] Speaker 00:
That's the chance.

[00:24:05] Speaker 00:
This is a search for the truth.

[00:24:06] Speaker 00:
We're trying to get to the real answers here, and the real answers require the court to reopen this and to look at it.

[00:24:13] Speaker 00:
If the court wants to find

[00:24:15] Speaker 00:
that if we win on the record below, then even better.

[00:24:20] Speaker 00:
But I do think that the search of the truth requires the special master to kind of do her job.

[00:24:26] Speaker 00:
She didn't want to get into the subtype.

[00:24:27] Speaker 00:
She says that on page 2.

[00:24:29] Speaker 00:
She didn't want to get into Campelabacter.

[00:24:31] Speaker 00:
But she used Campelabacter as the reason to reject the petitioner's evidence.

[00:24:34] Speaker 00:
And that's inappropriate.

[00:24:35] Speaker 02:
I appreciate your candor on the remand.

[00:24:37] Speaker 02:
I had understood you also thought you needed a remand because the special master did not make a finding on Alfin Factor 1.

[00:24:45] Speaker 02:
She simply assumed that you could have met your burden, but I don't think she actually made a finding.

[00:24:50] Speaker 00:
I agree with that.

[00:24:50] Speaker 00:
I don't think she actually made that finding.

[00:24:52] Speaker 02:
I think she says it's likely she... So you would need a remand for that reason as well.

[00:24:56] Speaker 00:
I agree.

[00:25:00] Speaker 00:
My friend talked about the treating physicians who say that the treating physicians were concerned about the diarrhea.

[00:25:08] Speaker 00:
Well, the treating physicians also note that the vaccine and a number of their

[00:25:12] Speaker 00:
history saying the person just got a vaccine.

[00:25:14] Speaker 00:
That's why the distinguishing between these two possibilities needs more development.

[00:25:23] Speaker 03:
Chancellor, as you say, your time is up.

[00:25:25] Speaker 03:
Do you want to finish your thought?

[00:25:27] Speaker 00:
Well, I would just finish the thought that we disagree strongly that

[00:25:34] Speaker 00:
even with the finding, if the special minister had made a finding one way or another, that the petitioner still wins, I think that's impossible.

[00:25:42] Speaker 03:
Thank you.

[00:25:43] Speaker 03:
Thank you, counsel.

[00:25:44] Speaker 03:
The case is submitted.

[00:25:45] Speaker 00:
Thank you.