[00:00:00] Speaker 04:
This morning is number 15-5141, Dangelini versus HHS.

[00:00:06] Speaker 04:
Mr. Kringle.

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

[00:00:14] Speaker 01:
In evaluating these vaccine cases, I think it's important to look at the congressional intent and the cases that have incorporated the meaning of what the Vaccine Act is for and how it is to be decided.

[00:00:27] Speaker 01:
The words that are used are awards that are being made quickly, easily, with certainty and generosity, a fair, simple, and easy way to administer, and preponderance of the evidence is defined as 50% and a feather.

[00:00:42] Speaker 01:
Mr. De Angelini's case is the antithesis of congressional intent and what case law is held.

[00:00:48] Speaker 01:
It's been 17 years, protracted litigation, and I would submit that the special master

[00:00:54] Speaker 01:
elevated the burden of proof that was impossible to meet in this case.

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The special master specifically forgot the imperative dictated law.

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That is, the purpose of the Vaccines Act's preponderant standard is to allow the finding of causation in a field bereft of complete and direct proof of how vaccines affect... But the special master held that he failed, your client failed to establish that he suffered from a medical condition at all.

[00:01:21] Speaker 01:
Yes, that's exactly what he held.

[00:01:23] Speaker 01:
And in particular, what I want to zero in on is the finding that he did not establish chronic fatigue syndrome, CFS.

[00:01:31] Speaker 03:
That's a question of fact, right?

[00:01:33] Speaker 01:
No.

[00:01:33] Speaker 01:
That is not a question of fact when you elevate the burden.

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Once you elevate the burden and make it impossible to find that, then it's not a question of fact.

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It's a question of law.

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In particular, the law that he found was, and the way he set it up was, if

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you do not know the etiology of CFS, which is true, like many of the vaccines and the illnesses and maladies that come before this court, then you can't prove your case.

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That's not what often helps.

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That is turning it upside down on its head.

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Moreover, that particular finding or theory of burden of proof actually contradicts with the statute.

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in particular, Section 3AA13, subparagraph small a to capital A, which specifically, and now this part of the statute pertains to respondent's burdens once the burden shifts.

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But it says you cannot include any idiopathic, unexplained, unknown, hypothetical, undocumented cause to deny a petition or compensation.

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So if a respondent cannot use an idiopathic, an unknown reason,

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then a special master certainly can't make our burden that high.

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The special master also ignored capizona, which the court recognized that in the absence of direct proof, the role of circumstantial evidence and program value of statements to treating physicians containing medical records is extremely important.

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And moreover, Knudsen holds to require identification and proof

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specific biological mechanisms would be inconsistent with the purpose and nature of the vaccine compensation program.

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And that's exactly what he wanted.

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But the problem isn't that the special master required specific proof of the connection between chronic fatigue syndrome and the vaccination.

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It's that the special master found, based upon a lot of evidence, that he didn't suffer from chronic fatigue syndrome at all.

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And that is an error.

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And I'll tell you why.

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You had two experts here testifying.

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This is where you're on an evidence question, right?

[00:03:53] Speaker 01:
No.

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I'm on an admission level.

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When you have the testifying experts, both Dr. Schoenfeld for me and Dr. Lightfoot for the respondent.

[00:04:05] Speaker 01:
You think the government has conceded that he has chronic fatigue syndrome?

[00:04:08] Speaker 02:
Absolutely.

[00:04:08] Speaker 02:
Yes.

[00:04:09] Speaker 02:
Well, here's the quote.

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I suspect that they're going to disagree with you.

[00:04:13] Speaker 01:
Well, they can, but here's the quote.

[00:04:16] Speaker 01:
I hope I don't ruin this case for you.

[00:04:19] Speaker 01:
This was on direct.

[00:04:20] Speaker 01:
He was not under duress by me under cross-examination.

[00:04:24] Speaker 01:
He prefaces his remarks by saying, I hope I don't ruin this case for you, and talks about a couple other facts.

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I think that was the beginning of his chronic fatigue syndrome.

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And albeit, he says it was secondary to depression, but I can argue that one separately.

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If that isn't a concession or admission by the government.

[00:04:44] Speaker 01:
It isn't.

[00:04:45] Speaker 01:
Why not?

[00:04:46] Speaker 03:
Don't ask the court questions.

[00:04:48] Speaker 03:
Pardon me?

[00:04:49] Speaker 03:
You don't ask the court questions.

[00:04:50] Speaker 01:
No, no.

[00:04:50] Speaker 01:
I'm sorry.

[00:04:52] Speaker 01:
You should be.

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It was a rhetorical question.

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I don't know what more could be in admission.

[00:04:58] Speaker 03:
Because you're taking it out of context, counsel.

[00:05:01] Speaker 03:
I looked it up.

[00:05:03] Speaker 01:
All right.

[00:05:04] Speaker 01:
I respectfully disagree.

[00:05:07] Speaker 01:
Dr. Lightfoot further conceded he was first diagnosed with chronic fatigue syndrome by Dr. Bach on October 10, 1998.

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He further, under questioning by the special master, acknowledged that the fatigue he suffered was comparable and would characterize as chronic fatigue syndrome.

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Not to mention, we have five treating physicians that diagnosed my client with CFS as a result of the hepatitis B vaccine, as well as Dr. Schoenfeld.

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Rhetorically, I ask, what more does one have to prove, considering the dictates of Alton, Andrew, Katsana, all of these cases that outline how one has to prove these cases.

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If you have five treating physicians, and I would still say there was a concession by Dr. Lightfoot, that's it.

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The special master's findings are fact.

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And I accept 99% of them.

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What I find arbitrary and capricious in this regard is that he ignored his own findings of fact or failed to apply those findings of fact to the law.

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He found that Mr. De Angelini suffered no physical ailments before the vaccines.

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He found that he had no fatigue or chronic fatigue before the vaccines.

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A month and a half before he had his first vaccine, he was given a pre-employment exam.

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cleared to work, he held two jobs, he had normal blood tests.

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Everything that the special master found would clearly indicate when you go to causation or what he had that he was functioning perfectly well and he was functioning in two jobs.

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Then we can look at the often criteria.

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A reliable theory causally connecting the vaccine to the injury.

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By definition, a theory is an idea that is suggested or presented as possibly true, but it is not known or proven to be true.

[00:07:18] Speaker 01:
Again, if the starting point that there is no medical knowledge of the cause of CFS, I can't prove my case.

[00:07:27] Speaker 01:
I can't prove it.

[00:07:29] Speaker 01:
Compare that with the holding of Andrew, which showed that the first prong can be satisfied when a medical theory is propounded by medical experts with highly relevant academic credentials

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and specific field expertise, such as those presented by Dr. Schoenfeld, as prima facie evidence of biologic plausibility.

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The special master even admits or acknowledges that the aluminum adjuvant theory, in this case, does have biologic plausibility.

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In fact, it's not a novel concept.

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It was first derived by Gerardi in his work on microphagic myofasciitis.

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And the theory posits that the illumine in the vaccine becomes deposited in the muscle, which disrupts muscle fiber and causes fatigue.

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Therefore, I would submit that that prong of Elf often was resolved.

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The second prong, a logical sequence of cause and effect showing that the vaccine was the reason for the injury.

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Here, again, according to Capizzano, treating doctor's opinions are favored for the second prong.

[00:08:33] Speaker 01:
Again, they're

[00:08:34] Speaker 01:
The special master's findings, in fact, concluded there was no prior diagnosis, signs, symptoms, or treatment of CFS.

[00:08:41] Speaker 01:
And again, the case law of Andrew and Moberly guide us that the treating physicians are in the best position to determine whether a logical sequence of cause and effect shows the vaccine is the reason for the injury.

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Five treating doctors diagnosed him.

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Third prompt, proximal and temporal relationship between the vaccine and CFS.

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The case laws also hold that one evidence in one prong can be used to satisfy another prong.

[00:09:11] Speaker 01:
In this case, we have three vaccines, and we have five doctors saying the CFS was caused by the vaccine.

[00:09:23] Speaker 01:
I think from a logical viewpoint, if you find causation, one must also find an approximate temporal relationship

[00:09:32] Speaker 01:
Because if you don't have an approximate temporal relationship, you can have causation.

[00:09:39] Speaker 01:
Dr. Schoenfeld testified that he would expect symptoms.

[00:09:42] Speaker 01:
It's not diagnosis.

[00:09:43] Speaker 01:
It's symptoms to develop within weeks to months of the vaccine.

[00:09:48] Speaker 01:
Last year, the case of Pollock versus HHS also found that that particular time frame was acceptable when talking about vaccines and their ill effects.

[00:10:02] Speaker 01:
Remember, CFS is a diagnosis of exclusion.

[00:10:05] Speaker 01:
You have to have six months of fatigue before you even get to the diagnosis, and you have to eliminate other causes.

[00:10:12] Speaker 01:
So that's why, in this case, when you have nothing ahead of time, I'm into my little bottle.

[00:10:19] Speaker 04:
All right.

[00:10:20] Speaker 04:
I'm going to save it.

[00:10:21] Speaker 04:
Thank you, Mr. Kendall.

[00:10:23] Speaker 04:
Ms.

[00:10:23] Speaker 04:
Perlman.

[00:10:27] Speaker 00:
Good morning.

[00:10:28] Speaker 00:
May it please the court, with all due respect to my counsel,

[00:10:32] Speaker 00:
very much disagree that whether or not Mr. De Angelini has... Let me tell you the one thing that bothers me.

[00:10:38] Speaker 00:
Sure.

[00:10:39] Speaker 04:
And that is for a diagnosis of CFS you have to have four out of six symptoms.

[00:10:51] Speaker 00:
Four out of eight.

[00:10:54] Speaker 04:
And apparently the special master concluded that

[00:10:59] Speaker 04:
there was a possibility that he had three of them after the vaccine, but that he dismissed the evidence that he had three others because those symptoms predated the vaccine.

[00:11:15] Speaker 04:
Am I summarizing it correctly?

[00:11:17] Speaker 00:
Kind of.

[00:11:18] Speaker 00:
Part of the definition for the ancillary criteria is that ancillary symptoms could not have predated the fatigue.

[00:11:26] Speaker 00:
So you have to use the fatigue

[00:11:28] Speaker 00:
the chronic fatigue, the serious fatigue, as the starting point.

[00:11:32] Speaker 00:
The other symptoms, the ancillary symptoms, have to have come after.

[00:11:36] Speaker 00:
So the three particular symptoms that the Special Master identified all preceded not just the chronic fatigue, but preceded the vaccine.

[00:11:46] Speaker 04:
So by... See, that's, I mean, that seems to me kind of odd to say that because somebody had some symptoms earlier, they can't have chronic fatigue, even if they had all the

[00:11:57] Speaker 04:
even if they had all eight symptoms, coincident with the episode or whatever you want to call it.

[00:12:09] Speaker 04:
Where is the diagnostic criterion in the record here?

[00:12:13] Speaker 00:
It is the TAN criteria.

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It is an appendix to the special master's decision, and it begins on page A205.

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and goes through A207.

[00:12:31] Speaker 00:
Your Honor, to be clear, we're not talking about chronic fatigue, the general symptom.

[00:12:36] Speaker 00:
We are talking about a very specific syndrome, chronic fatigue syndrome.

[00:12:40] Speaker 00:
It has diagnostic criteria that there was no question in this case that that is the criteria that we... Okay, so but where does it say here, where does it deal with the question of pre-existing?

[00:12:56] Speaker 00:
Turn to page 207.

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Under major classification categories, subsection two, the chronic occurrence of four or more of the following symptoms.

[00:13:09] Speaker 00:
And it says, all of which must have persisted or recurred during six or more consecutive months of illness and must not have predated the fatigue.

[00:13:20] Speaker 04:
Seems like a very odd requirement.

[00:13:23] Speaker 00:
Well, it's the requirement that Paducah and his colleagues at the CDC came up with for this particular condition.

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It is the condition that petitioner is alleging that he has.

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So this is the criteria that has been used.

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And there was no question throughout the proceedings that this was the criteria that petitioner was trying to achieve in order to prove that he has chronic fatigue syndrome.

[00:13:52] Speaker 03:
OK.

[00:13:53] Speaker 03:
I'd like you to address, please, the Whitefoot statement, and specifically, I want you to discuss his testimony found later in the record, starting at 1346.

[00:14:09] Speaker 00:
Sure.

[00:14:10] Speaker 00:
The statement that counsel discussed, I think we have to be very clear what the question was first.

[00:14:18] Speaker 00:
The question was, Doctor, this is at page 27 of Appellant's Brief,

[00:14:23] Speaker 00:
Doctor, what is your opinion about when Mr. De Angelini's Chronic Fatigue Syndrome started if we were to assume he has Chronic Fatigue Syndrome?

[00:14:31] Speaker 00:
So at the very outset, the question is predicated on an assumption that Mr. De Angelini in fact has Chronic Fatigue Syndrome.

[00:14:39] Speaker 03:
As I said, it was out of context.

[00:14:41] Speaker 00:
I agree with that.

[00:14:43] Speaker 00:
Another problem with this statement is that Dr. Lightfoot's answer says

[00:14:50] Speaker 00:
Yes, he uses the word chronic fatigue syndrome.

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It is our position that he misspoke when he said syndrome after chronic fatigue.

[00:14:57] Speaker 00:
And I think it was secondary to his depression primarily.

[00:15:01] Speaker 00:
Chronic fatigue syndrome is a diagnosis of exclusion.

[00:15:05] Speaker 00:
And chronic fatigue is certainly a symptom of depression.

[00:15:11] Speaker 03:
But he's also asked to presume that it exists.

[00:15:14] Speaker 00:
In this case, yes.

[00:15:16] Speaker 03:
In the question.

[00:15:17] Speaker 03:
But then go on to his tip.

[00:15:19] Speaker 03:
separate testimony.

[00:15:21] Speaker 00:
Yes.

[00:15:22] Speaker 00:
Which part in particular?

[00:15:24] Speaker 03:
A1346 at Seek, where he's testifying about it.

[00:15:32] Speaker 03:
Because I want that nailed down.

[00:15:35] Speaker 03:
I'm sorry?

[00:15:35] Speaker 03:
I want it nailed down, and I want it nailed down because, as I said, you're opposing counsel.

[00:15:40] Speaker 03:
I thought he was making a misrepresentation.

[00:15:43] Speaker 00:
And I agree.

[00:15:48] Speaker 00:
So chronic fatigue syndrome, irritable syndrome, and fibromyalgia are all included in sort of a Venn diagram relationship where they overlap.

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Some people only have one.

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Some people have two or three of those.

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And what the clinicians try to do is to find the disease and treat it and get rid of the fatigue.

[00:16:06] Speaker 00:
And he goes on.

[00:16:07] Speaker 00:
And that is why the special master gave so much weight to one of the treating physicians, Dr. Norris.

[00:16:14] Speaker 00:
She actually looked at the chronic fatigue syndrome criteria

[00:16:18] Speaker 00:
and concluded that he does not have chronic fatigue syndrome.

[00:16:22] Speaker 00:
Again, there is no doubt that there are certain places in the record where a diagnosis of chronic fatigue syndrome is present.

[00:16:30] Speaker 00:
But there was no basis given for why it was that these doctors came to this conclusion.

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There's no evidence they held it up against the criteria.

[00:16:39] Speaker 00:
And during the testimony, Dr. Vasey, who is one of the people who said he had chronic fatigue syndrome,

[00:16:45] Speaker 00:
admitted that his sole reason for saying that he had this diagnosis was because that Mr. De Angelini was chronically fatigued, period.

[00:16:53] Speaker 00:
Nothing to do with the ancillary criteria.

[00:16:55] Speaker 04:
It would have been better if the government lawyer examining Dr. Lightfoot had asked him to clear up what he meant by that.

[00:17:05] Speaker 00:
In hindsight, I agree with you, Your Honor.

[00:17:07] Speaker 00:
We had four days of very long testimony.

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And I'm sure, looking back, there are questions we wish we had asked.

[00:17:15] Speaker 00:
But I believe that the evidence in this case is vast.

[00:17:21] Speaker 04:
But the significant thing, it seems to me, about Dr. Lightwood is he wasn't an expert in chronic fatigue syndrome.

[00:17:27] Speaker 00:
Nor was Dr. Vasey or Dr. Schoenfeld.

[00:17:31] Speaker 00:
I think that was a deficiency on all parts.

[00:17:33] Speaker 00:
But it is petitioner's burden to prove by preponderant evidence that he has the conditions that he is alleging is vaccine related.

[00:17:41] Speaker 00:
He did not do that.

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And the special master gave multiple reasons why.

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It is a factual finding.

[00:17:48] Speaker 00:
It is a substantial deference by this court's precedent.

[00:17:52] Speaker 00:
I think in a 106 page decision, it would be hard to find that he did not fully evaluate all of the evidence.

[00:17:59] Speaker 00:
He weighed the evidence.

[00:18:00] Speaker 04:
Well, he didn't mention this evidence as a problem.

[00:18:03] Speaker 04:
It would have been good if he'd done that, too.

[00:18:05] Speaker 00:
I agree.

[00:18:05] Speaker 00:
I will say that in over 1,500 pages of transcript, the first time this paragraph was pointed out was at this court's during briefing.

[00:18:13] Speaker 00:
It was not pointed out during post-hearing briefing or during briefing for the Court of Federal Claims.

[00:18:19] Speaker 00:
So I don't know why it was not picked out earlier, but it wasn't.

[00:18:25] Speaker 00:
And I believe, as Judge Wallach said, it was taken out of context.

[00:18:32] Speaker 00:
If there are no further questions, we respectfully request that you affirm the Special Master's decision.

[00:18:37] Speaker 04:
Thank you, Ms.

[00:18:37] Speaker 04:
Perlman.

[00:18:39] Speaker 04:
Mr. Kringle?

[00:18:40] Speaker 01:
First of all, I'd like to apologize to Judge Wallach.

[00:18:48] Speaker 01:
My advocacy got the best of me, and it came out.

[00:18:55] Speaker 01:
I would take... That's accepted.

[00:18:58] Speaker 01:
Thank you.

[00:19:01] Speaker 01:
I would disagree about taking this out of context.

[00:19:05] Speaker 01:
Again, and I hate, I don't want to beat a dead horse, but when an expert says in response to a... Is it true that you didn't point this out to the special master in the briefing?

[00:19:15] Speaker 04:
That is correct.

[00:19:18] Speaker 04:
So, doesn't give him an opportunity to address it then, really?

[00:19:24] Speaker 01:
There were other areas where I disputed his finding of CFS.

[00:19:30] Speaker 01:
from day one not finding CFS, lower court, his court, special master.

[00:19:37] Speaker 01:
All of it going back to essentially his finding that if there's no etiology of CFS, then you've presented a heightened burden towards.

[00:19:48] Speaker 03:
But when you ask somebody, this is what bothers me about this in addition to his later testimony, or actually earlier testimony.

[00:19:55] Speaker 03:
Yeah.

[00:19:56] Speaker 03:
But when you ask someone to assume that

[00:20:00] Speaker 03:
that the patient has something, and he says, well, OK, he has it.

[00:20:04] Speaker 03:
You've just asked him to assume it.

[00:20:06] Speaker 03:
And I think it's out of context when you argue it that way.

[00:20:11] Speaker 01:
The only thing I can respond to that is you're dealing with an expert who has testified quite a bit in this court.

[00:20:19] Speaker 01:
And when he responds with a prefatory comment that, I hope I don't ruin this case for you, well, everyone's ears start picking up.

[00:20:28] Speaker 01:
He's not talking about ruining the case

[00:20:30] Speaker 03:
for the government.

[00:20:31] Speaker 01:
Well, he is, because it was direct exam.

[00:20:35] Speaker 01:
This wasn't me asking.

[00:20:37] Speaker 01:
It was direct exam.

[00:20:38] Speaker 01:
So the case he was ruining, arguably, was the government's case.

[00:20:45] Speaker 01:
And then he starts talking about chronic fatigue syndrome.

[00:20:49] Speaker 01:
It has to start at some point in time.

[00:20:50] Speaker 01:
They're not born with it.

[00:20:52] Speaker 01:
I believe this was clearly starting in him with these stories of non-restorative sleep.

[00:20:57] Speaker 01:
Even in spite of sleeping for 10 hours, he was not rested.

[00:21:00] Speaker 01:
He had suicidal ideation before the vaccines ever came along.

[00:21:04] Speaker 01:
I think that was the beginning of his chronic fatigue syndrome.

[00:21:08] Speaker 01:
And I think it was secondaries to his depression.

[00:21:12] Speaker 01:
I mean, that's a direct answer.

[00:21:14] Speaker 01:
That's not an assumption.

[00:21:15] Speaker 04:
But I'll tell you what your problem is.

[00:21:17] Speaker 04:
I mean, even if you interpret this testimony the way you do, first of all, he's not an expert in chronic fatigue syndrome.

[00:21:23] Speaker 04:
And second of all, there's other evidence that cuts the other way, and that's what

[00:21:28] Speaker 04:
fact-finders are supposed to do is to weigh the evidence.

[00:21:31] Speaker 04:
And the special master found against you, and it looks as though there's substantial evidence, plenty of evidence, to support his finding that he wasn't suffering from chronic fatigue syndrome, even if you accept the characterization of a lightfoot testimony the way you characterize it.

[00:21:48] Speaker 01:
Well, there are, again, five treating physicians that held that he had chronic fatigue syndrome as a result of the hepatitis B vaccine.

[00:21:57] Speaker 03:
Well, they opined.

[00:21:59] Speaker 03:
They opined.

[00:22:01] Speaker 01:
Yes, they opined.

[00:22:03] Speaker 01:
And that's, based on the case law, what I think, as advocates, we have to rely upon.

[00:22:13] Speaker 01:
You gather up, hopefully, you're treating physicians.

[00:22:16] Speaker 01:
They come forward.

[00:22:17] Speaker 01:
Your experts come forward.

[00:22:19] Speaker 01:
You present it.

[00:22:20] Speaker 03:
The trier effect gets to observe the demeanor of the witnesses.

[00:22:25] Speaker 01:
No question about it.

[00:22:28] Speaker 01:
But again, this was one portion of this.

[00:22:32] Speaker 01:
I still go back to the special masters, in essence, beginning and end of the discussion, because if you say there's no etiology to chronic fatigue syndrome, you've basically elevated my burden in contradiction of often to that which cannot be provable.

[00:22:49] Speaker 01:
No etiology, I can't win.

[00:22:52] Speaker 01:
Nor can anyone else if that's the burden.

[00:22:55] Speaker 01:
Thank you very much.

[00:22:56] Speaker 04:
Okay.

[00:22:57] Speaker 04:
Thank you, Mr. Crandall.

[00:22:58] Speaker 04:
Thank both counsels.

[00:22:59] Speaker 04:
The case is submitted and it concludes our session for the day.