[00:00:00] Speaker 04:
The next case before the court is Cottenstedt versus Secretary of HHS.

[00:00:05] Speaker 04:
Case number 20-2282 is appeal from the Court of Federal Claims, which in turn heard an appeal from the Vaccine Special Master.

[00:00:20] Speaker 04:
Mr. McHugh, are you ready to proceed?

[00:00:23] Speaker 01:
I am, Your Honor.

[00:00:25] Speaker 04:
Okay.

[00:00:25] Speaker 04:
Go ahead.

[00:00:27] Speaker 01:
Thank you, Your Honors.

[00:00:28] Speaker 01:
My name is John McHugh, and I'm representing the family of CK, as we call her in the record.

[00:00:34] Speaker 01:
She is the daughter of the Cottonstead family.

[00:00:38] Speaker 01:
She was born on June 1, 2012, and she was developing normally until October 2, 2012, when she received four vaccines, including DPAT, and within a few hours, that happened at 1045 in the morning,

[00:00:55] Speaker 01:
and at 8.30 in the evening she had the first of her lifelong seizures which have continued and are devastating and have essentially destroyed her basically her life.

[00:01:08] Speaker 01:
So the issues before the court today are the remand of Special Master Millman's December of 2017 decision granting compensation and the

[00:01:23] Speaker 01:
And then the second part of that is, after remand, the court then sustained the decision of Special Master Horner, which denied it.

[00:01:35] Speaker 06:
Counselor, I have a question on the first remand.

[00:01:40] Speaker 06:
Did the court remand with instruction?

[00:01:42] Speaker 06:
And in your view, exactly what was the basis of the remand?

[00:01:47] Speaker 06:
A failure to apply the appropriate legal standard?

[00:01:51] Speaker 06:
or was there a failure of evidence to meet that standard?

[00:01:55] Speaker 01:
The court held that under Boatman it was an error for the special master to rely on Dr. Marcel Kinsborn's opinion that the DTAP vaccine shot can do the same damage as DPT but less frequently.

[00:02:14] Speaker 01:
Now this came up in the hearing

[00:02:17] Speaker 01:
And it actually, Dr. Kinsport was testifying, and the special master, and it's quoted in both our briefs, asked him a specific question.

[00:02:27] Speaker 01:
She said she'd seen this before.

[00:02:28] Speaker 01:
Now, you have to understand here, this is a special master who was sitting on that court 28 years at this time.

[00:02:34] Speaker 01:
And she's talking to a pediatric neurologist who'd been doing this work for 60 years and had been an expert in this court since it started.

[00:02:43] Speaker 01:
and was also involved in specific research involving DPAT long ago.

[00:02:48] Speaker 01:
At any rate, she asked him, she said, she understands that some people say you cannot use a study of DPT in order to determine whether DPAT can cause the same thing because DPT is far more dangerous than DPAT.

[00:03:06] Speaker 01:
DPAT is safer.

[00:03:08] Speaker 01:
And she said she believed that safer is not safe.

[00:03:12] Speaker 01:
And therefore, the study that she's referring to is the Bellman study.

[00:03:15] Speaker 01:
It was part of the National Children's Encephalopathy study in 1983 that had found that pertussis vaccines, or DT and DPT, caused the onset of, not the onset, it triggered onset of

[00:03:40] Speaker 01:
Infantile spasms within one week after the delivery of the DPT and DT vaccinations.

[00:03:51] Speaker 04:
Where in the record exactly did Special Master Millman say that?

[00:03:56] Speaker 01:
Oh, in the record.

[00:03:57] Speaker 01:
Okay, let's see.

[00:03:58] Speaker 04:
Yeah, because it's not in her opinion.

[00:04:01] Speaker 01:
That's not in her opinion.

[00:04:03] Speaker 01:
She refers to it, but she doesn't cite it.

[00:04:06] Speaker 01:
Where does she say it?

[00:04:08] Speaker 01:
Okay.

[00:04:08] Speaker 02:
I should have that, but I don't.

[00:04:14] Speaker 02:
That's a very good question.

[00:04:37] Speaker 04:
Okay.

[00:04:40] Speaker 04:
Well, maybe you can find it and tell me on rebuttal.

[00:04:43] Speaker 04:
But did you introduce any evidence that that was the case, that it may be safer, but it's not safe?

[00:04:56] Speaker 04:
Was there any other evidence?

[00:05:00] Speaker 01:
At the time, we had not introduced evidence on that point.

[00:05:05] Speaker 01:
In our complaint, I should say our petition, we had cited the case law

[00:05:10] Speaker 01:
where the vaccines were basically treated equally.

[00:05:14] Speaker 01:
And we also cited that in the 42 CFR section 100.3, the table, the reactions to all three of these vaccines, DPT and DPAT, were treated equally.

[00:05:31] Speaker 01:
So the government saw no difference.

[00:05:34] Speaker 01:
Case law saw no difference.

[00:05:36] Speaker 01:
And decisions that we did put into the record

[00:05:39] Speaker 01:
showed that the manufacturer saw no difference.

[00:05:43] Speaker 01:
So essentially, everybody agreed that DPAT and DPT both could cause seizures, and that's all we were interested in.

[00:05:53] Speaker 01:
All that author requires is that we show it can happen.

[00:05:58] Speaker 01:
But this is a special master who said she'd seen it before, so she was essentially taking judicial notice of the fact that she believed

[00:06:05] Speaker 01:
that just because it's safer doesn't mean it doesn't do the same thing.

[00:06:08] Speaker 01:
Therefore, she could refer to the Bellman study and its findings that a pertussis vaccine, even an attenuated one, if indeed a seizure disorder of this type shows up within one week, then... But the table that you referred to when you're saying the government

[00:06:32] Speaker 04:
doesn't see a difference.

[00:06:33] Speaker 04:
That refers to acute spasms that CK did not suffer, isn't that right?

[00:06:40] Speaker 01:
There is nothing worse than infantile spasms.

[00:06:43] Speaker 01:
Infantile spasms are lifelong and they're about as bad as you can get.

[00:06:48] Speaker 01:
So there's nothing unacute about these spasms.

[00:06:52] Speaker 01:
She had them and it happened within 10 hours and then it kept happening.

[00:06:58] Speaker 01:
And it was diagnosed a few days later by the Boston Children's as being the infantile spasms.

[00:07:06] Speaker 01:
And it was treated with moderate success by the use of this drug, ACTH.

[00:07:13] Speaker 01:
And that becomes quite critical later on in this.

[00:07:16] Speaker 01:
ACTH is a steroid produced by the brain in response to any stress.

[00:07:23] Speaker 01:
where the brain releases an excitability hormone, which is basically what they call it, RCH.

[00:07:40] Speaker 01:
But anyway, ACT dampened this in her.

[00:07:45] Speaker 01:
Now, Dr. Kingsborne was involved at Great Osborne Street Hospital in London

[00:07:51] Speaker 01:
57 and 58 in a study that determined that ACT could be used to treat infantile spasms.

[00:08:02] Speaker 01:
And they determined that the problem with kids who have infantile spasms is their brain does not produce enough ACT in response to any stimuli.

[00:08:11] Speaker 01:
And that could be a vaccine or an infection or anything else to dampen the stress response that causes excitability in the brain.

[00:08:21] Speaker 01:
because of the presence of the other compound.

[00:08:26] Speaker 06:
Counselor, I don't want you to run out of time here without addressing some of these other questions.

[00:08:33] Speaker 06:
And I'm concerned as to what happened in the procedure here.

[00:08:37] Speaker 06:
So the Court of Appeals remansed to the special master.

[00:08:42] Speaker 06:
A new special master, Master Horner, takes over the case.

[00:08:46] Speaker 06:
Correct?

[00:08:47] Speaker 06:
Am I correct so far?

[00:08:47] Speaker 06:
That's correct.

[00:08:49] Speaker 06:
What is it that the special master

[00:08:51] Speaker 06:
was supposed to do, to have a de novo hearing or to review the opinion of Special Master Milner?

[00:09:01] Speaker 01:
He was to review the opinion of Special Master Milner.

[00:09:04] Speaker 01:
He did not have a de novo hearing.

[00:09:06] Speaker 01:
And so, at that hearing, we attempted, under the federal evidence,

[00:09:12] Speaker 01:
to ask him to take judicial notice of what Special Master Millman had stated, that it was safer but not safe, and therefore you could.

[00:09:23] Speaker 06:
And this particular point you're talking about now, is this the point that the Court of Federal Claims said was unclear?

[00:09:32] Speaker 01:
No.

[00:09:33] Speaker 01:
The Special Master on remand actually found

[00:09:37] Speaker 01:
that DPAT could cause the seizure disorder so that prong one of Alton was met.

[00:09:43] Speaker 01:
He then, however, went through Dr. Kinsborne, Dr. Kinsborne explained how the vaccine, he was not talking necessarily about just DPAT, he was talking about all of them.

[00:09:53] Speaker 01:
She got four vaccines that day.

[00:09:55] Speaker 01:
Every one of them would cause an immune reaction, which would set off this chain reaction of the brain, which causes a, an, an executary

[00:10:06] Speaker 01:
a hormone to be produced, and then that is neutralized by the act.

[00:10:11] Speaker 03:
Mr. McHugh, this is Judge Stoll.

[00:10:13] Speaker 03:
I just want to make sure I follow up on Judge Raina's question before your time runs out.

[00:10:18] Speaker 03:
What are you relying on, for example, in the Court of Federal Claims mandate or order to suggest that the special master coroner was obligated

[00:10:35] Speaker 03:
to follow any of the facts, findings, or anything of Special Master Millman?

[00:10:42] Speaker 01:
Well, I don't believe there was anything that required him to do so.

[00:10:46] Speaker 01:
But the fact is that he went through, he ruled that Special Master Millman was correct with regard to the connection between DPAT and seizures.

[00:10:59] Speaker 01:
Where is that?

[00:11:02] Speaker 01:
He did say at some point, he did say that it was barely, he barely satisfied prong one.

[00:11:11] Speaker 01:
Satisfied prong one, he satisfied that it could happen, all right?

[00:11:15] Speaker 01:
Then his error was, he held that because there was no fever in this child at the time of the first seizure, that obviously there was no autoimmune reaction, I mean immune reaction that Dr. Kinsfer was talking about to set off this chain of events.

[00:11:31] Speaker 01:
Unfortunately, this is a vaccine court.

[00:11:34] Speaker 01:
And vaccines cause an immune reaction period across the board without exception.

[00:11:39] Speaker 01:
And the presence of fever is irrelevant.

[00:11:42] Speaker 01:
Some people, everybody, all of us probably got vaccines recently.

[00:11:45] Speaker 01:
How many of us got fevers?

[00:11:47] Speaker 01:
You do not need a fever to have an immune reaction.

[00:11:50] Speaker 01:
It happens without fever or with it.

[00:11:52] Speaker 01:
And so that, as far as we're concerned, that is arbitrary and capricious, especially in a vaccine court.

[00:11:58] Speaker 01:
which is dealing with this stuff all the time.

[00:12:00] Speaker 06:
So did Special Master Horner determine, what did Special Master Horner review?

[00:12:09] Speaker 06:
The sufficiency of the evidence that Special Master, before Special Master Milner, the sufficiency of that evidence?

[00:12:19] Speaker 06:
Yes.

[00:12:20] Speaker 06:
Did Special Master Horner reweigh

[00:12:22] Speaker 06:
the evidence?

[00:12:23] Speaker 01:
Yes, that was one of the problems.

[00:12:25] Speaker 01:
He reweighed the evidence on the whole thing and reached his own conclusion.

[00:12:29] Speaker 01:
He essentially reversed a special, well, I don't know if he did, he sustained Special Master Millman on the issue that was before him, which was whether she had sufficient evidence before her to reach the conclusion that the Bellman study was relevant.

[00:12:46] Speaker 01:
And so,

[00:12:47] Speaker 06:
But he didn't do that, so that was all... When you said reverse, and now we're getting to the point where, for me, the rubber meets the road.

[00:12:56] Speaker 06:
You have one special master that's reviewing the decision of another special master.

[00:13:01] Speaker 06:
Right.

[00:13:01] Speaker 06:
At the behest of the court of federal claims, it clearly has the jurisdiction and authority, the obligation to review properly appealed decisions of a special master.

[00:13:13] Speaker 06:
But here, it seems to me that Special Master Horner was reviewing, acting as a, quote, a federal claims judge, and reviewing Special Master Milner's opinion.

[00:13:24] Speaker 01:
Well, you're absolutely right.

[00:13:25] Speaker 01:
He did do that, and that is not his job.

[00:13:28] Speaker 01:
And so basically, she had reached this conclusion.

[00:13:32] Speaker 01:
He determined initially that she was correct because the vaccine could do it.

[00:13:38] Speaker 01:
and therefore her conclusion that if it can do it, the Bellman study is relevant, is sustained to some extent.

[00:13:44] Speaker 01:
He then goes further and says, because the Special Master Millman had not gone through the Alton prongs, he determined he'd do it himself and deemed that even though she was right on prong one, she was wrong that prong two had not been sustained because of the lack of the fever.

[00:14:08] Speaker 01:
And that is, it wasn't his job because he has- Okay, counsel, we're way past your time.

[00:14:14] Speaker 04:
I'll restore three minutes for rebuttal, but I think we need to hear from the government.

[00:14:19] Speaker 01:
Thank you.

[00:14:20] Speaker 04:
Ms.

[00:14:20] Speaker 04:
Collette, are you prepared to go forward?

[00:14:23] Speaker 00:
I am.

[00:14:25] Speaker 00:
May it please the court.

[00:14:26] Speaker 00:
My name is Camille Collette and I represent the Secretary of Health and Human Services.

[00:14:31] Speaker 00:
The original special master committed legal error because she did not evaluate the evidence under the preponderant evidence standard in Alton.

[00:14:38] Speaker 00:
which has been a legal standard in the vaccine program since 2005, and which has been applied in the off-table, in the evaluation of off-table cases since then.

[00:14:46] Speaker 00:
She did not evaluate the evidence under the correct legal standard, and this is not a close case.

[00:14:51] Speaker 04:
Is that, is that what the Court of Claims actually said, or did the Court of Claims say that Knudsen didn't stand for the proposition that she thought it did, and so, because that infected her legal analysis, that it had to go back?

[00:15:09] Speaker 00:
Well, I think that it had to go back for that reason, and I think it also had to go back because she did not evaluate the evidence under Alton, and there was no sound and reliable medical theory that was put forth here.

[00:15:26] Speaker 00:
And that Bellman and Melchior were inadequate evidence to find Alton strongly.

[00:15:30] Speaker 04:
Did the court of plaint actually make those

[00:15:33] Speaker 04:
findings with respect to the rest of the factual record, I thought that it pretty much based its decision on the fact that Newton didn't say what, or they believe Newton didn't say what she thought it did.

[00:15:53] Speaker 00:
No, I mean, I think that the court remanded because they found

[00:16:03] Speaker 00:
that Newton didn't say what she thought it did.

[00:16:06] Speaker 04:
Right.

[00:16:07] Speaker 04:
And so beyond that, and I think this might go to the questions that Judge Raina was asking, I mean, they did not do an analysis of the rest of the findings or the rest of the factual record, did they?

[00:16:23] Speaker 00:
They did not.

[00:16:24] Speaker 00:
He evaluated the record and found facially that it was apparent that the correct legal standard had not been applied.

[00:16:31] Speaker 04:
Right.

[00:16:33] Speaker 04:
Okay.

[00:16:34] Speaker 04:
Now, let me then ask you, on remand, Special Master Horner did not take any new testimony, correct?

[00:16:42] Speaker 00:
He did not.

[00:16:43] Speaker 00:
He did not.

[00:16:46] Speaker 00:
And really, the facts of this case are largely undisturbed.

[00:16:49] Speaker 00:
I mean, he didn't really reweigh the evidence.

[00:16:52] Speaker 00:
This case involves a failure of proof.

[00:16:56] Speaker 00:
Petitioners did not prove by preponderant evidence

[00:16:59] Speaker 00:
a medical theory linking vaccines, the DTaP vaccines to infantile spasms.

[00:17:04] Speaker 00:
They did not prove a logical sequence of cause and effect.

[00:17:07] Speaker 00:
And they did not.

[00:17:09] Speaker 04:
But on the record, though, the first time around, didn't Special Master Millman specifically ask the expert about the ability to, basically to apply the information about

[00:17:28] Speaker 04:
DTP to DTAP and he said it could.

[00:17:33] Speaker 00:
So that testimony, that evidence was provided by our expert Dr. Zempel when in his initial report where he opined that conflating the DTP studies, conflating the effects of DTP to DTAP, that there were just real limitations with that evidence.

[00:17:56] Speaker 04:
And in my pre-hearing brief, which is... Yeah, but I guess what I'm trying to understand is that the first time around, Special Master Millman specifically asked the expert if the Bellman study could apply to DTAP, and that expert said yes.

[00:18:16] Speaker 04:
She accepted that testimony, found it to be credible and reliable, and the second time around,

[00:18:24] Speaker 04:
Special Master Horner just said Bellman's completely irrelevant because he weighed the testimony differently.

[00:18:31] Speaker 04:
I guess what I'm trying to understand is how he could make that determination when he didn't hear the experts testify.

[00:18:40] Speaker 00:
Well, actually, he did not.

[00:18:43] Speaker 00:
He actually accepted Bellman as having limited relevance.

[00:18:49] Speaker 00:
It's Melchior that he rejected because it was a distinct vaccine formulation.

[00:18:55] Speaker 00:
These are distinct vaccine formulations.

[00:18:58] Speaker 00:
The acellular pertussis vaccine is a distinct vaccine from the full cell pertussis vaccine, and there is no evidence that DTaP causes infantile spasms, which is another point that I would like to correct that Mr. McHugh made in his opening, which is that infantile spasms are not seizures.

[00:19:18] Speaker 00:
Infantile spasms are an epileptic encephalopathy of childhood that presents with co-occurring encephalopathy, epileptic spasms, and hypserysmia on EEG.

[00:19:33] Speaker 00:
Seizures and infantile spasms cannot be conflated.

[00:19:36] Speaker 00:
They are not the same thing.

[00:19:48] Speaker 06:
When I read the Special Master Horner's decision, I'm left with the distinct impression that he reweighed the evidence anew.

[00:20:01] Speaker 06:
That instead of looking at Special Master Milner's decision to determine whether the accurate legal standard was applied or not, and that's a yes or no answer.

[00:20:12] Speaker 06:
Instead, the Special Master not only reviewed the record anew,

[00:20:18] Speaker 06:
but made new findings, reached a different conclusion on the application of the legal standard, and then denied petitioner the opportunity to submit evidence that went to the very questions that Special Master was reviewing.

[00:20:42] Speaker 00:
Well, I think when the court remanded

[00:20:47] Speaker 00:
The court actually vacated the original special master's decision and remanded the case for reconsideration under the correct legal standard.

[00:20:54] Speaker 00:
So I think, you know, under the correct legal standard.

[00:20:58] Speaker 06:
Excuse me.

[00:20:59] Speaker 06:
It was a reconsideration of the, it was, the special master was asked to make a new decision on the basis of the record or just to make a new decision on the basis of the correct legal standard.

[00:21:12] Speaker 06:
Correct?

[00:21:13] Speaker 00:
Correct.

[00:21:14] Speaker 00:
On the basis of the correct legal standard and in evaluating that evidence.

[00:21:18] Speaker 06:
Now hold on.

[00:21:19] Speaker 06:
So the special master did actually conduct a de novo hearing or a de novo review based on what the special master thought was the correct legal standard.

[00:21:36] Speaker 03:
Counsel, is that a yes or a no?

[00:21:39] Speaker 03:
Because you'd need to answer the question, did Special Master Horner reweigh the evidence anew?

[00:21:45] Speaker 03:
Did he do that?

[00:21:47] Speaker 03:
It's just a yes or a no.

[00:21:48] Speaker 03:
And then I have another follow-up question for you.

[00:21:53] Speaker 03:
No, I think that he applied... He deferred to the Special Master Millman's findings, or did he make his own independent findings?

[00:22:04] Speaker 00:
He applied the legal standard to the findings that he had made.

[00:22:08] Speaker 03:
Okay, so did he make new fact findings?

[00:22:13] Speaker 00:
He came to some different conclusions, yes.

[00:22:17] Speaker 00:
Okay, on that, did he make new fact findings?

[00:22:19] Speaker 03:
Yes, he did.

[00:22:21] Speaker 03:
Correct?

[00:22:22] Speaker 00:
Correct.

[00:22:23] Speaker 03:
Okay, now I have another question for you.

[00:22:26] Speaker 03:
When I look at page A42 with the remand language from the Court of Federal Claims, it says,

[00:22:31] Speaker 03:
The case is remanded to the Special Master to consider the petitioner's theory and evidence under the correct legal standard.

[00:22:38] Speaker 03:
Do you think this gave Special Master Horner the ability or authority to reweigh the facts?

[00:22:49] Speaker 00:
I think it gave him the authority to evaluate the facts under the correct legal standard.

[00:22:57] Speaker 00:
I don't think he reweighed the evidence.

[00:23:01] Speaker 00:
I think he applied the legal standard to the facts from the original.

[00:23:11] Speaker 03:
I was just going to ask, are you aware of any authority that would say that Judge Horner either can or cannot reweigh the evidence?

[00:23:25] Speaker 03:
Do the fact-finding become, in essence, for lack of a better word, law of the case when they're not appealed?

[00:23:40] Speaker 03:
Yes.

[00:23:42] Speaker 03:
They do become law of the case?

[00:23:43] Speaker 03:
Okay.

[00:23:44] Speaker 03:
Thank you.

[00:23:46] Speaker 00:
What's the legal authority on that?

[00:23:53] Speaker 00:
I don't have an answer.

[00:23:54] Speaker 00:
My fingers

[00:23:55] Speaker 00:
I don't have an answer at my fingertips, I apologize.

[00:24:11] Speaker 04:
Okay, go on.

[00:24:18] Speaker 00:
Special master's coroner's decision on remand was correct and should not be disturbed.

[00:24:25] Speaker 00:
He found that petitioners failed to meet the burden under ALSIN.

[00:24:29] Speaker 00:
He evaluated the evidence.

[00:24:32] Speaker 00:
He declined to extrapolate the studies that involved wholesale pertussis to the current Acellular Formation based on Dr. Kinsborne's testimony alone because it was not explained.

[00:24:45] Speaker 00:
He looked at the Melchior study and found that the conclusions in that study were based on statistical observations

[00:24:52] Speaker 00:
and limited the applicability of that study both because he gave limited weight to Bellman because it tested a standalone diphtheria tetanus vaccine in addition to testing DPT, but found that there was inadequate support to find that the DTaP vaccine can cause infantile spasms under the first prong of the Alton test.

[00:25:18] Speaker 06:
Um, but he did find elsewhere on, on, on that basis, right there, the new finding, and now we're getting to where you're actually using in your argument, new findings are using the word.

[00:25:30] Speaker 06:
So we, let's say that the, the special master owner made new findings and that means we weighed the evidence, we considered it.

[00:25:39] Speaker 06:
And, uh, and why is it not error that the special master refused to allow the petitioner to submit

[00:25:49] Speaker 06:
what they considered to be evidence on the very question that was under review.

[00:25:54] Speaker 06:
And I say that in view of the fact that the vaccine act is remedial in nature.

[00:25:59] Speaker 06:
Our court has said this a number of times.

[00:26:02] Speaker 06:
This is a remedial act.

[00:26:05] Speaker 06:
While there may be some adversarial aspect to it, it's not supposed to be an adversarial contest here.

[00:26:16] Speaker 00:
Understood.

[00:26:16] Speaker 00:
You know, I think that

[00:26:19] Speaker 00:
that the special master considered the evidence in decline to introduce it because it's not relevant to the question at hand here.

[00:26:30] Speaker 00:
The evidence, the articles that petitioner wanted to introduce both before Special Master Horner and before Judge Hartling, and which are now in the appendix, in the joint appendix, they speak to seizures, febrile seizures, not to infantile spasms.

[00:26:46] Speaker 00:
Infantile spasms are a distinct

[00:26:49] Speaker 00:
injury of early childhood that we don't know in the majority of cases how they are caused.

[00:26:56] Speaker 00:
And the evidence that Petitioner is putting forth or the articles that he was putting forth and has put forth in the appendix actually speak to febrile seizures, which are not at issue here.

[00:27:18] Speaker 04:
Okay, Council, let's just hear the rebuttal.

[00:27:23] Speaker 04:
Mr. McHugh.

[00:27:24] Speaker 01:
Thank you, Your Honor.

[00:27:25] Speaker 01:
As to your question before, part of the transcript is Appendix 1495 is the conversation that starts on Line 9 and goes down to Line 19.

[00:27:40] Speaker 01:
She basically says these are the two sides of this story.

[00:27:43] Speaker 01:
Some people say you can't use DPT to deal with DPAT.

[00:27:48] Speaker 01:
She says she disagrees and believes it's relevant because safer is not safe.

[00:27:53] Speaker 01:
Therefore, what has been found in the Bellman study applies.

[00:27:57] Speaker 01:
Now the Bellman study is unique because it was dealing with infantile spasms specifically.

[00:28:04] Speaker 01:
And so it found that infantile spasms were triggered, not caused, triggered by the vaccine within seven days.

[00:28:12] Speaker 01:
So essentially Special Master Millman and Special Master Millman explained

[00:28:16] Speaker 01:
that the Bellman study had been very careful in what it was doing.

[00:28:20] Speaker 01:
It isolated the two or three vaccines it was dealing with and separated all the classes out, and they had basically done a very good job of making sure they didn't merge results.

[00:28:30] Speaker 01:
But the Bellman study found that within one week of the DPAT and the DT vaccines, all three of those, of course, all of those are relevant at DPAT because they're all in the same place, and all of them found that one week afterward there was an uptick.

[00:28:46] Speaker 03:
Mr. McHugh, I have a quick question.

[00:28:48] Speaker 03:
Just for clarification to make sure I understand, looking at the pages 1495 to 96, and I'm to understand that your safer but not safe language is a paraphrase of what she said, right?

[00:29:03] Speaker 03:
It's not a quote, right?

[00:29:05] Speaker 01:
Well, she says basically...

[00:29:09] Speaker 01:
that there's still reactions that you can use to its analysis, because it's just... I see that.

[00:29:15] Speaker 01:
Thank you.

[00:29:15] Speaker 01:
It's in there.

[00:29:17] Speaker 01:
Not all of us speak precisely.

[00:29:19] Speaker 01:
As to what Special Master Horner did, he did reweigh the evidence.

[00:29:25] Speaker 01:
He refused to allow us to put in evidence that was directly on point, and especially the Canadian study, which determined not only that it was safer, but it was 76% safer.

[00:29:36] Speaker 01:
I mean, they came down to an actual number.

[00:29:38] Speaker 01:
And other studies that say, even though it's safer, we are seeing the same value, the same injuries in the same ratio to each other.

[00:29:45] Speaker 01:
In other words, if you have, it's reduced, but it looks like the same thing, but smaller.

[00:29:51] Speaker 01:
And so Special Master Melman was perfectly correct in determining that the Bellman study, which was the only thing we can find on infantile spasm specifically, the Bellman study was useful.

[00:30:05] Speaker 01:
As to the confusion between seizures, and we're talking about brain injuries, but Dr. Kilman, Kinsborn's work in 1957 and 58 was specifically on infantile spasms and the effect of act, or A, whatever that is, act on dampening that reaction.

[00:30:25] Speaker 01:
And the fact that that is a naturally produced product of the brain,

[00:30:29] Speaker 01:
And so if ACT works, it indicates that the missing, the lack of ACT is the cause of the condition that makes this kid an eggshell plaintiff.

[00:30:40] Speaker 01:
She is susceptible to anything that sets off her immune reaction, and a vaccine is going to do it a lot better than basically a flu.

[00:30:51] Speaker 01:
Here she had four vaccines.

[00:30:53] Speaker 01:
Dr. Kinsborn was not focused exclusively on DPAT.

[00:30:57] Speaker 01:
He was focused on the fact that she got four vaccines that morning and had a reaction.

[00:31:02] Speaker 01:
Look at the split.

[00:31:03] Speaker 01:
He testified that normally when infantile spasms are detected, it takes months for them to become clinical.

[00:31:12] Speaker 01:
It is a very insidious problem that comes up.

[00:31:15] Speaker 01:
And to the fact that it happened in 10 hours,

[00:31:19] Speaker 01:
and that is intractable.

[00:31:21] Speaker 01:
Infantile spasms also tend to disappear as the child grows.

[00:31:25] Speaker 01:
This one didn't.

[00:31:27] Speaker 01:
It didn't go down and after active became drug resistant.

[00:31:30] Speaker 01:
Right now this child is essentially just alive and seizing several times a day.

[00:31:36] Speaker 01:
At the hearing she was seizing continuously.

[00:31:39] Speaker 01:
So this is a tragic case and this is supposed to be, and I agree, this is a remedial program and we shouldn't be playing gotcha.

[00:31:47] Speaker 04:
Okay, Council.

[00:31:48] Speaker 04:
Okay, your time is up.

[00:31:50] Speaker 01:
Thank you.

[00:31:50] Speaker 04:
Thank you very much.

[00:31:51] Speaker 04:
All right, the case will be submitted.

[00:31:53] Speaker 00:
The Honorable Court is adjourned until tomorrow morning at 10 a.m.