[00:00:00] Speaker 01:
The last case for argument this morning is 21-1524 Wright versus HHS.

[00:00:07] Speaker 01:
Ms.

[00:00:07] Speaker 01:
Patton, whenever you're ready.

[00:00:09] Speaker 02:
Thank you.

[00:00:11] Speaker 02:
The issue before the court today is whether diagnostic tests performed more than six months after vaccine administration can satisfy the vaccine severity requirement, even if those tests confirm

[00:00:25] Speaker 02:
that the injured person no longer suffers from the alleged injury.

[00:00:29] Speaker 02:
Specifically, we're looking at section 11C1D of the Vaccine Act, which states that a petition shall contain supporting documentation demonstrating that the person who suffered such vaccine-related injury suffered the residual effects or complications

[00:00:47] Speaker 02:
of such illness, injury, or condition for more than six months after administration of the vaccine.

[00:00:59] Speaker 01:
The tests confirm that they do not have the ITP.

[00:01:03] Speaker 01:
Correct.

[00:01:04] Speaker 01:
That suggests, perhaps, that your position would be different if this individual were tested for ITP, as he was, and the tests showed that he had it, with platelet count.

[00:01:19] Speaker 01:
Correct.

[00:01:20] Speaker 02:
If those tests showed that he was still suffering from ITP, he would still be suffering from that injury or condition.

[00:01:29] Speaker 04:
Would you have to, do you accept that if he had a low platelet count, say at the 12 month mark, that that low platelet count would in fact be connected to the low platelet count that he had right after the vaccine, or might it be a unconnected thing?

[00:01:50] Speaker 02:
Is your question, just so I can understand and answer it properly, that there are no intervening tests, and you're looking at a test 12 months in the future?

[00:02:01] Speaker 04:
I guess I just want to understand what your, you said to Judge Prost that your position would be different.

[00:02:08] Speaker 04:
Would your position be that yes, that would mean that he would qualify?

[00:02:15] Speaker 04:
from a low platelet count more than six months after full stop without further inquiry?

[00:02:21] Speaker 04:
Or would there be a further inquiry about whether that low platelet count is actually a residue of the earlier one?

[00:02:29] Speaker 02:
I understand.

[00:02:30] Speaker 02:
If there had, as in this case, been a full resolution of the injury,

[00:02:35] Speaker 02:
And then later, there's a test that had low platelets.

[00:02:39] Speaker 02:
We would need to take a look at the record to see the circumstances surrounding that.

[00:02:47] Speaker 02:
In the qualifications and aids to interpretation, for example, it specifically states that thrombocytopenia caused by an infection, including rhinovirus, the common cold, is specifically not something that could be compensated.

[00:03:02] Speaker 02:
So it's not something easy.

[00:03:05] Speaker 02:
to address in a vacuum?

[00:03:07] Speaker 01:
Well, let's talk about this case then.

[00:03:10] Speaker 01:
Sure.

[00:03:11] Speaker 01:
I mean, this case at some level was resolved, but it's a little confusing to me based on the record, because it was resolved, but there is still a recommendation that they continue to be periodic testing.

[00:03:23] Speaker 01:
And you just said, not resolved, but fully resolved.

[00:03:27] Speaker 01:
In this case, if he had tested positive,

[00:03:31] Speaker 01:
Not possible.

[00:03:32] Speaker 01:
I'm sorry.

[00:03:32] Speaker 01:
You understand.

[00:03:33] Speaker 01:
If he had had the low play to let come, would the government have considered that a continuation of the initial condition and compensable?

[00:03:45] Speaker 01:
You understand what I'm saying?

[00:03:48] Speaker 02:
Sure.

[00:03:49] Speaker 02:
So if the test that had been performed

[00:03:54] Speaker 02:
after six months, if he was continuing to be monitored by his hematologist and his platelet counts continued to be... No, no, no.

[00:04:02] Speaker 02:
I'm talking about this case.

[00:04:03] Speaker 01:
And you know the facts, I hope, better than I do.

[00:04:05] Speaker 01:
Yes.

[00:04:06] Speaker 01:
Which is his platelet count went up to normal.

[00:04:10] Speaker 01:
So there was some suggestion that this was resolved.

[00:04:14] Speaker 01:
But there was also a medical

[00:04:17] Speaker 01:
assertion, and consistent with the medical standard of care, that if he demonstrated some symptoms, at least within the period we're talking about, which is like two years, then it could be related to ITP.

[00:04:31] Speaker 01:
And therefore, he needs to be tested for ITP.

[00:04:34] Speaker 01:
That's our case.

[00:04:35] Speaker 01:
I'm not dealing with hypothetics.

[00:04:37] Speaker 01:
So in this circumstance, I thought you started, and I wanted to probe, because you said even in this circumstance where it didn't confirm he had ITP.

[00:04:47] Speaker 01:
If he had the same test and the test showed low platelets, is it the government's position that that would be compensable?

[00:04:59] Speaker 02:
So in this case where there was, actually I should say this case, we might have had to go back to the experts because the child did have an infection prior to at least his April 2016 test results, platelet counts that were normal.

[00:05:17] Speaker 02:
If he continued to have, which he doesn't in this case, if he had continued to have low platelet counts, then his ITP would not have been resolved.

[00:05:26] Speaker 03:
Can I just clarify or ask you to clarify for me what you're saying here?

[00:05:32] Speaker 03:
Are you saying if he had a continuing low platelet count that was attributable to ITP, that would be compensable?

[00:05:42] Speaker 03:
But it's not just the low platelet test as a result of a low platelet count that would make it compensable.

[00:05:48] Speaker 03:
It has to be an effect of the conditions caused by it.

[00:05:52] Speaker 03:
So there can be any number of reasons why you have a low platelet count.

[00:05:57] Speaker 03:
and why you would monitor it after you've had a condition like this.

[00:06:01] Speaker 03:
But it's only a low platelet count that somebody connect to this condition that would be compensable, not just a test and, oh, yes, low platelet count.

[00:06:12] Speaker 02:
That's absolutely correct.

[00:06:13] Speaker 02:
It has to be a residual effect or complication of that initial diagnosis of ITP.

[00:06:19] Speaker 01:
And what do we do with that?

[00:06:20] Speaker 01:
I mean, I thought that's why at least it was the medical decision that because of his precondition of ITP, that's why he should have this test.

[00:06:32] Speaker 01:
Presumably, that means that there's some greater likelihood or risk or relationship between the prior incidence of ITP and the passage of a year or two or whatever.

[00:06:46] Speaker 01:
So when he demonstrates bruising,

[00:06:48] Speaker 01:
It's not because if he had never had ITP, he would have come in and they would have said, you need an ITP shot.

[00:06:55] Speaker 01:
It's given his history, presumably, my understanding, non-medical understanding, is because it's given the context

[00:07:04] Speaker 01:
it makes it more likely.

[00:07:05] Speaker 01:
I don't know.

[00:07:06] Speaker 01:
I mean, I asked if the government has a position on that because you suggested that there's a distinction here because he didn't have ITP.

[00:07:14] Speaker 01:
But if he had, the result would have been different.

[00:07:16] Speaker 01:
And I'm trying to see what that result, what that different result looks like.

[00:07:22] Speaker 02:
We have many of these cases in the program.

[00:07:26] Speaker 02:
There aren't.

[00:07:27] Speaker 02:
A case like this is not compensable.

[00:07:29] Speaker 02:
Those that are compensable, the children would continue to be on medication.

[00:07:35] Speaker 02:
There was no medication at all in this case ever needed.

[00:07:38] Speaker 02:
They would continue to go in, and they're not considered.

[00:07:40] Speaker 01:
Continue when?

[00:07:41] Speaker 01:
Beforehand?

[00:07:42] Speaker 01:
Like this particular individual, you're saying it would not be compensable because he hadn't been continued to be on medication or stopped?

[00:07:50] Speaker 02:
No, it's not compensable because he had fully recovered from his ITP within three months.

[00:07:57] Speaker 02:
He may have even fully recovered under a table definition which strictly defines ITP as a... Okay, so, well, firstly, I'm not sure in the record it says fully recovered.

[00:08:07] Speaker 01:
One person said recovered.

[00:08:09] Speaker 01:
But explain to me then what you understand from the medical stuff.

[00:08:13] Speaker 01:
There is indication that they said, yes, you've recovered from your first bout with ITP.

[00:08:19] Speaker 01:
But they continue to say, if you exhibit bruising, I mean, this was a medically required thing.

[00:08:27] Speaker 01:
This wasn't discretionary.

[00:08:29] Speaker 01:
Let me finish.

[00:08:30] Speaker 01:
So if the same doctors or different doctors that said you've recovered say, but if you exhibit symptoms like bruising, it's medically necessary or medically desirable that we test you for ITP, suggesting that that indicates

[00:08:49] Speaker 01:
that you haven't really recovered.

[00:08:52] Speaker 01:
And so if we're talking about recovery as opposed to getting something new and different, either because you had a pre-existing disposition, which nobody ever mentions here.

[00:09:04] Speaker 01:
Nobody mentions that there would be another reason or that it wouldn't be related, even though they said he's recovered.

[00:09:10] Speaker 01:
So can you explain that to me?

[00:09:11] Speaker 01:
Sure.

[00:09:12] Speaker 02:
I believe, and I hope I'm addressing your question correctly, is it is standard medical care based on his history that he had that testing when he showed up with bruising, even though in the medical records it indicates he had typical childhood bruising.

[00:09:29] Speaker 02:
This is a young child.

[00:09:30] Speaker 02:
with bruises on their shins, on their arms, all of the time.

[00:09:34] Speaker 02:
And in the records, it specifically notes multiple times typical childhood bruising.

[00:09:40] Speaker 02:
In the majority of the cases where they did the platelet counts, the mother requested that they do the platelet counts to check, which

[00:09:47] Speaker 01:
Well, we have testimony that says that it was medically standard procedure to do the testing, given the bruises.

[00:09:54] Speaker 01:
So you might say it's the mother, except my premise, so that I'm saying that it was medically necessary, because that's what I think all the experts said.

[00:10:02] Speaker 02:
I do think that the crux of the matter here is that in order to find that in this case, the child BW met the six-month severity requirement,

[00:10:14] Speaker 02:
you have to find that the testing alone, even though that testing showed he did not have low platelets, and even though the bruising is actually not, it could have been potential symptoms, but it was not symptoms of ITP.

[00:10:29] Speaker 02:
So to know.

[00:10:29] Speaker 03:
Can I ask that a different way?

[00:10:32] Speaker 03:
Is there an argument that effects of a disease could mean higher risk?

[00:10:38] Speaker 03:
So that therefore, you would have testing in certain instances for people that have a higher risk because they previously suffered it.

[00:10:47] Speaker 03:
And for people that haven't suffered it, you wouldn't have this testing.

[00:10:51] Speaker 03:
Is that the kind of way you would understand the testing to be an effect?

[00:10:59] Speaker 03:
You're not, and I'm not saying I agree with this, but fully recovered in this instance means fully recovered, same as somebody that never had it before, not fully recovered from the symptoms and whatever it was causing, but still at high risk, a higher, not high risk, a higher risk so that if these symptoms recur, you might want to test.

[00:11:22] Speaker 02:
I don't think there's any evidence in the record that he would be at a higher risk

[00:11:27] Speaker 02:
of having the condition that began.

[00:11:29] Speaker 01:
Then why did all the experts and everybody say that it was standard medical care, that given his previous situation, if he shows symptoms, he should be tested?

[00:11:41] Speaker 01:
That wouldn't be true if he didn't have this prior condition.

[00:11:46] Speaker 01:
So I think that was what Judge Hughes was sort of getting at.

[00:11:52] Speaker 01:
I didn't think it was controverted

[00:11:56] Speaker 01:
It was medically desirable or proper or consisting with medical care for him to get this testing because of his prior condition.

[00:12:05] Speaker 02:
Right, but I don't think we have anything in the record that states that this child had a higher likelihood of a recurrence of the condition.

[00:12:15] Speaker 03:
But why would you answer that?

[00:12:18] Speaker 03:
I would assume you would have just said the higher risk is still not within the statutory definition.

[00:12:24] Speaker 03:
That what you have to have is an actual effect of the disease or condition, not just a risk that it might have been that.

[00:12:33] Speaker 03:
And I think you agreed that

[00:12:36] Speaker 03:
If they're because of the risk, and they did the testing, and it turned out these symptoms, the bruising was attributable to this, it would have been compensable.

[00:12:46] Speaker 02:
Correct.

[00:12:47] Speaker 02:
And our position is that that's set forth in the Chief Special Master's initial decision and incorporating the decision in Crabby.

[00:12:58] Speaker 02:
And it also has the definition, the medical definition of residual effects in the Parsley case.

[00:13:03] Speaker 02:
Those are other

[00:13:05] Speaker 03:
I want to clarify one thing because I'm a little worried about what you're asking us to do and if it's too broad in some sense.

[00:13:14] Speaker 03:
I want to make sure that this is not what you're saying and that it's not just that you keep having to have actual symptoms and something that disease causes, whether it's bruising here or not.

[00:13:27] Speaker 03:
What if it's a disease that you can control entirely with medication

[00:13:32] Speaker 03:
But if you go off medication, they will come back.

[00:13:36] Speaker 03:
You don't require somebody to go off the medication and have the symptoms to be compensable, do you?

[00:13:42] Speaker 03:
If they get a disease caused by a vaccine that can be controlled by medication, but they have to continue taking that medication for two years, does that take it beyond the six-month period?

[00:13:55] Speaker 02:
I believe that's addressed, although just at the special master level at Fowl.

[00:13:59] Speaker 02:
In the FAP case that's referred in here, that's a very different situation than what we have.

[00:14:05] Speaker 02:
Well, I understand.

[00:14:06] Speaker 03:
That's why I ask a hypothetical.

[00:14:08] Speaker 03:
It seems like that would be a continuing effect, which is you're required to take medication to control symptoms.

[00:14:16] Speaker 03:
And if you didn't, they would reappear.

[00:14:19] Speaker 03:
And that's not the same thing as requiring tests to disprove or prove that you have it.

[00:14:27] Speaker 03:
You would make a distinction there.

[00:14:28] Speaker 02:
Yes.

[00:14:29] Speaker 02:
Yes, and I think if there were expert testimony that said were it not for the medication, there was a high likelihood that the symptoms would recur

[00:14:39] Speaker 02:
And also, unlike in this case, where there are some statements that the condition had resolved, that's a very different situation.

[00:14:45] Speaker 02:
I think the petitioner would be.

[00:14:47] Speaker 01:
Well, let me just ask you one final thing.

[00:14:49] Speaker 01:
The drawing of the blood in this circumstance was not routine care.

[00:14:54] Speaker 01:
It was required or initiated solely because he had had this previous thing with ITP.

[00:15:01] Speaker 01:
So he had to undergo an invasive medical procedure, which was the direct result of the vaccine injury.

[00:15:09] Speaker 01:
Why is that not sufficient?

[00:15:11] Speaker 01:
I think it's a limited circumstance.

[00:15:13] Speaker 01:
But assuming suffering means nothing more than experiencing, why isn't that experiencing the residual effects of his initial vote with the ITP?

[00:15:26] Speaker 02:
I think our position is really that the residual effects aren't just diagnostic testing.

[00:15:33] Speaker 02:
And in terms of suffering, when you say an invasive procedure, that's actually unclear too.

[00:15:37] Speaker 02:
The only notation that there was an actual venopuncture where there was multiple tubes taken was in the initial hospitalization.

[00:15:45] Speaker 02:
There's one that shows it was just a finger prick.

[00:15:49] Speaker 02:
We don't know from the other tests whether it was done with a finger prick or a full

[00:15:53] Speaker 02:
So in terms of an invasive procedure, I don't know, I think at least... Well, let's assume it was, hypothetically.

[00:16:01] Speaker 01:
If it was something we should all agree on what the definition of an invasive procedure is, and we were talking about that.

[00:16:07] Speaker 01:
Would that be sufficient to satisfy suffering, medical, the residual effects?

[00:16:12] Speaker 02:
I don't believe so.

[00:16:14] Speaker 02:
I think in order to do that, you're finding that the testing alone

[00:16:18] Speaker 02:
is a residual effect of the injury.

[00:16:19] Speaker 02:
And I think the medical definition, which should be used because this is a statute based on complicated medical injuries, and the residual effects when one looks at the medical definition requires more than just mere testing.

[00:16:36] Speaker 02:
You need to have some.

[00:16:38] Speaker 01:
I guess your answer.

[00:16:39] Speaker 01:
Can I just ask you one more thing, and this isn't

[00:16:42] Speaker 01:
This is more of a policy question, so I feel a little uncomfortable asking.

[00:16:47] Speaker 01:
But it feels very wrong to me that if you were willing, let's say hypothetically, to say if this kid, they had taken the test and he had shown to be ITP, it would have been quite clear, given all the medical records, that this was the residual effect and he would be compensated.

[00:17:05] Speaker 01:
But let's assume we have some families that can't afford the first test.

[00:17:09] Speaker 01:
or would forego the testing for this, even though the kid had symptoms of bruising, because they can't pay for it.

[00:17:17] Speaker 01:
So that's the situation we're arguably in, where even though this would be an invasive medical procedure necessary, a result of his earlier bout with ITP, and necessary to determine whether or not he's got ITP, which would be likely, if not

[00:17:37] Speaker 01:
clearly compensable by the government that's foregone, because the government doesn't cover that little piece of it.

[00:17:46] Speaker 02:
I do think, with all due respect, that the hypothetical about the families not affording it is that hospitals can't turn you back.

[00:17:56] Speaker 02:
Every state in the US has some sort of Medicaid for children.

[00:18:03] Speaker 03:
Can I ask you this?

[00:18:05] Speaker 03:
I'm a little confused about this, and I could have followed it up and read the record.

[00:18:09] Speaker 03:
And essentially, I didn't.

[00:18:10] Speaker 03:
They're not just asking to cover the cost of the testing, are they?

[00:18:15] Speaker 03:
They're asking for the lump sum payment you get under the table for having this disease.

[00:18:20] Speaker 02:
They're not asking for any out-of-pocket expenses.

[00:18:23] Speaker 02:
This child was on Medicaid, so the government paid for all of this child's care.

[00:18:28] Speaker 04:
Um, the family didn't, um, the money here was the lion's share of it was pain and suffering plus 4,000 and change for a Medicaid lien for what?

[00:18:40] Speaker 02:
For a Medicaid lien for Medicaid.

[00:18:42] Speaker 02:
So Medicaid, the government paid for all of this child's care.

[00:18:45] Speaker 02:
So the only damages they were seeking is an award for pain and suffering.

[00:18:50] Speaker 04:
Can you tell?

[00:18:51] Speaker 04:
me anything about the practical consequences of finding this case to fall under the statute.

[00:19:06] Speaker 04:
How common is it that people who receive vaccines have an injury that

[00:19:14] Speaker 04:
in terms of symptoms, resolves in less than six months, but that lead their medical professionals in the future to say, oh, I see on your chart you had this problem after the vaccine.

[00:19:31] Speaker 04:
I'm going to do something or other test-wise that I wouldn't otherwise have done.

[00:19:38] Speaker 04:
Is this a small class, a large class?

[00:19:41] Speaker 04:
do we know?

[00:19:42] Speaker 02:
In terms of children with injuries like this, it's small because we barely see any cases involving children these days.

[00:19:52] Speaker 02:
However, it could be very applicable and affect our cases for those that make up the vast majority of our docket.

[00:20:01] Speaker 02:
The vast majority of our docket is now made up of adults claiming orthopedic shoulder injuries as a result of vaccine.

[00:20:08] Speaker 02:
There are thousands of those cases.

[00:20:10] Speaker 02:
So if you were to find

[00:20:12] Speaker 02:
that because of someone's history, if they report to the doctor a year, year and a half later, you know, my shoulder really, really hurts, and the doctor orders an x-ray or MRI that shows nothing, under the reasoning of the Court of Federal Claims, that case meets the severity requirement, even if their injury had resolved months and months before, just by saying, my shoulder is hurting,

[00:20:38] Speaker 02:
and ordering diagnostic tests, regardless of what those tests show.

[00:20:43] Speaker 04:
But I guess I was trying to build into the hypothetical that those tests would not be ordered from the same complaint about symptoms in the absence of the history.

[00:20:59] Speaker 02:
Correct.

[00:21:00] Speaker 02:
And I think someone could say, I had a history.

[00:21:03] Speaker 02:
of a vaccine injury in my shoulder, like it may have completely resolved.

[00:21:08] Speaker 02:
But they say the pain is the same.

[00:21:09] Speaker 02:
I really think I still have the problem.

[00:21:13] Speaker 02:
And if the doctor orders an x-ray or an MRI, under the reasoning of the Court of Federal Claims in this case, that case meets the severity requirement.

[00:21:22] Speaker 02:
And I do not think that is what Congress intended.

[00:21:24] Speaker 02:
Congress intended to only compensate those cases that involved serious injuries.

[00:21:31] Speaker 02:
That's noted in this court's decision in Clure.

[00:21:35] Speaker 02:
Again, it's not intended to compensate cases like this where the injury resolves in a matter of months.

[00:21:42] Speaker 02:
Maybe in this case, because the table defined ITP solely as a platelet count of under 50,000, this child may have resolved within a day or two of his presentation at the hospital.

[00:21:54] Speaker 02:
The act is intended to compensate people who suffer serious ongoing injuries.

[00:22:00] Speaker 01:
Thank you.

[00:22:01] Speaker 01:
Let's hear from the other side, and we'll restore a handover to it if we bottle up necessary.

[00:22:22] Speaker 00:
May it please the court.

[00:22:23] Speaker 00:
My name is Michael Milmo.

[00:22:24] Speaker 00:
I represent the petitioner, BW in this case, and his mother.

[00:22:30] Speaker 00:
I'd like to just start out by making a few general observations that I think are worth recognizing about the areas where the experts agreed in this case.

[00:22:40] Speaker 00:
That's kind of unusual for vaccine cases.

[00:22:42] Speaker 00:
I've been doing this for 35 years, and I can tell you that that's a very rare phenomenon within the vaccine program.

[00:22:52] Speaker 00:
The first is that

[00:22:54] Speaker 00:
had BW not suffered a vaccine injury, his ITP, his blood draws due to his later bruising and petechiae would never have been performed.

[00:23:03] Speaker 00:
And I think that's a very key point that the experts agree upon.

[00:23:07] Speaker 00:
Second is that the doctors who did these tests acted within the standard of care for a child who had ITP and then presents later

[00:23:17] Speaker 00:
with bruising and petechiae.

[00:23:18] Speaker 00:
They were actively doing the right thing to manage that.

[00:23:24] Speaker 00:
Now, I think it's important.

[00:23:25] Speaker 03:
I mean, I think we understand the facts.

[00:23:27] Speaker 03:
The real question is, does diagnostic testing alone, rather than diagnostic testing that reveals that the condition has not resolved, compensable?

[00:23:39] Speaker 03:
What evidence is there that Congress intended that?

[00:23:42] Speaker 00:
I think the evidence is in the language that they use in defining the severity requirement.

[00:23:51] Speaker 00:
That language is quite clear.

[00:23:55] Speaker 00:
The petitioner must have, quote, suffered the residual effects or complications of such illness, disability, injury, or condition for more than six months after the administration of the vaccine.

[00:24:06] Speaker 03:
I think the government's position kind of glosses over the issue of... What's clear about residual effects, including diagnostic testing, rather than just actual symptomology of the disease?

[00:24:20] Speaker 00:
Well, I think two things.

[00:24:23] Speaker 00:
One is that the...

[00:24:24] Speaker 00:
Language here makes clear that you don't have to have the actual illness, condition, disability, or injury for more than six months.

[00:24:37] Speaker 00:
Right, effects or complications.

[00:24:38] Speaker 00:
It's a lower standard than that because it's the residual.

[00:24:41] Speaker 03:
We're not talking about complications.

[00:24:42] Speaker 03:
You're not saying testing is a complication of the disease.

[00:24:45] Speaker 03:
We're talking about residual effects.

[00:24:47] Speaker 00:
Correct.

[00:24:47] Speaker 00:
That's what the court of federal claims found.

[00:24:50] Speaker 03:
isn't reading it in context with complications, suggesting that it's something that's caused by the disease in terms of symptoms.

[00:24:59] Speaker 03:
This is the effect you get when you have this condition, not you have to go get tested for this for two years to make sure it doesn't recur.

[00:25:06] Speaker 03:
Well, I think it's important to remember that the expert... I don't think... My basic point is I don't see this as plain, and so I want to understand how we resolve it after that.

[00:25:16] Speaker 00:
OK.

[00:25:17] Speaker 00:
Well, I think it's important to recognize that in this case here, there is no question.

[00:25:23] Speaker 00:
The experts agree that this child's ITP was caused by the vaccine.

[00:25:27] Speaker 00:
I mean, he meets a table definition.

[00:25:30] Speaker 00:
The government's challenging the severity requirement.

[00:25:32] Speaker 00:
But as for the table portion of the case,

[00:25:36] Speaker 00:
This is one of those rare cases where the government has actually acknowledged through their expert that this child suffered a vaccine injury because of the MMR shot that he got.

[00:25:48] Speaker 00:
And so I think, to me, the statutory language tells us that the fact that he did not have ITP on those later four tests that were done after the six-month requirement

[00:26:06] Speaker 00:
That's not just positive, just as Judge Brugink found.

[00:26:09] Speaker 00:
And the reason that's not just positive is because if he had had

[00:26:14] Speaker 00:
the bruising that caused this test to be done, and he had the platelet counts that were low, then he would have had proof of the illness, disability, injury, or condition for more than six months.

[00:26:26] Speaker 00:
But that's not what Congress intended.

[00:26:28] Speaker 00:
Congress intended it would be the residual effects or complications of such illness.

[00:26:33] Speaker 03:
Can I direct you to the legislative history of the 1987 amendment?

[00:26:39] Speaker 03:
you're familiar with this i'm sure yes it talks about you know because it changed this is where it changed from one year to six months i think i've got it correct because they were concerned about one year being too long apparently and compensating people for things that it you know or whatever reason but at least the legislative history i had suggests that um

[00:27:02] Speaker 03:
The subsection eliminates the act's provision.

[00:27:07] Speaker 03:
Well, let me go for that.

[00:27:08] Speaker 03:
It says, it limits compensation program cases in which a person dies from the result of a vaccine or which a person incurs unreversible medical expenses of more than $1,000 and suffers ongoing disabilities.

[00:27:25] Speaker 03:
for at least six months.

[00:27:26] Speaker 03:
And then it repeats, in the next part of that, disabilities.

[00:27:29] Speaker 03:
Now, effects is somewhat ambiguous.

[00:27:32] Speaker 03:
I think disabilities is not at all ambiguous.

[00:27:35] Speaker 03:
And diagnostic testing does not seem to me to fall within a definition of disability.

[00:27:44] Speaker 03:
Do you think testing is a disability?

[00:27:47] Speaker 00:
I don't think testing is a disability but I think ITP is a disability.

[00:27:58] Speaker 03:
the diagnostic testing alone, because I think the government has conceded that if the testing proved that he had it still after six months, then it would have been compensable, because he would have the disability.

[00:28:12] Speaker 03:
So if we read that legislative history as supporting, as defining what is a somewhat ambiguous term effect, why doesn't that

[00:28:25] Speaker 03:
require a reversal here.

[00:28:28] Speaker 00:
Well, I think, Your Honor, it's very important to recognize that that $1,000 requirement and that language was later stricken by Congress.

[00:28:37] Speaker 00:
That no longer applies.

[00:28:40] Speaker 03:
But it's not just talking about $1,000.

[00:28:42] Speaker 03:
It's talking about sufferers' ongoing disabilities.

[00:28:46] Speaker 03:
And it wasn't just striking the $1,000.

[00:28:49] Speaker 03:
It was changing the year to the six months.

[00:28:53] Speaker 00:
Yes, but the reason that it struck $1,000 is it was trying to be more inclusive.

[00:29:00] Speaker 00:
It wanted more people to be compensated, more children.

[00:29:02] Speaker 03:
But it was supposed to also being less exclusive by limiting the time frame from 12 months to six months.

[00:29:09] Speaker 03:
And neither of these are going to what they talk about, which is disabilities.

[00:29:15] Speaker 00:
Yes, but again, a residual effect is not the same as disability.

[00:29:20] Speaker 00:
Congress used the term disability in the act itself, in the severity requirements that suffered the residual effects or complications of such illness disability.

[00:29:31] Speaker 03:
But don't we only get to your point if we think effect plainly includes diagnostic testing?

[00:29:38] Speaker 03:
And if it's ambiguous, then at least we're not bound by the legislative history

[00:29:44] Speaker 03:
By any means, some people don't even believe in looking at legislative history.

[00:29:48] Speaker 03:
I am not one of those.

[00:29:50] Speaker 03:
And if I look at the legislative history and looking at what they were trying to do in this whole program, it's compensating for disabilities resulting from vaccines, not a requirement for testing.

[00:30:03] Speaker 03:
which is what your argument is.

[00:30:05] Speaker 00:
Well, my argument is kind of twofold.

[00:30:09] Speaker 03:
One is that- Let me make sure.

[00:30:10] Speaker 03:
Your argument is not that he had this disease more than six months after the vaccine, is it?

[00:30:16] Speaker 00:
That is correct.

[00:30:17] Speaker 03:
OK.

[00:30:18] Speaker 03:
Your argument is that diagnostic testing performed more than six months is an effect within the meeting of the statute.

[00:30:26] Speaker 00:
Yes.

[00:30:26] Speaker 03:
And if effect includes testing, then you win.

[00:30:29] Speaker 03:
If effect doesn't include testing, you lose.

[00:30:32] Speaker 00:
I think that's right, and Judge Brugink found that it did.

[00:30:36] Speaker 03:
Is that based on the plain language of what effect means?

[00:30:41] Speaker 00:
Yes, it is.

[00:30:42] Speaker 00:
It's part of the plain language of what the effect means, and it's also on the medical dictionary definition that the respondent uses.

[00:30:49] Speaker 00:
The medical dictionary says that it has to be something that results from

[00:30:54] Speaker 00:
the illness, disability, injury, or condition.

[00:30:59] Speaker 00:
It has to result from.

[00:31:00] Speaker 00:
That's the medical definition.

[00:31:02] Speaker 00:
That's the tougher definition that Judge Bruggen found we also met.

[00:31:07] Speaker 00:
But I mean, we meet that because the doctors acted because he suffered a vaccine injury.

[00:31:15] Speaker 00:
He had ITP.

[00:31:16] Speaker 00:
Let's just say that the government is correct.

[00:31:18] Speaker 00:
He only had it for three months.

[00:31:20] Speaker 00:
He had both parts of the ITP.

[00:31:22] Speaker 00:
He had the bruising, and he had the platelet counts.

[00:31:25] Speaker 00:
But after the six months, he continued to have the bruising.

[00:31:30] Speaker 00:
Now, what would you have these doctors do?

[00:31:32] Speaker 03:
There is no dispute that the doctors did the right thing in ordering these tests.

[00:31:38] Speaker 03:
and that the reason they did it was because he initially had this disease.

[00:31:42] Speaker 03:
The question is, did Congress intend for you to get this lump sum compensation award for diagnostic testing to confirm that he didn't have the disease, or did they only intend it if he continued to have the disease after six months?

[00:31:58] Speaker 00:
They intended for it to include diagnostic testing if that testing was related to the injury that the vaccine caused, as it did here.

[00:32:08] Speaker 03:
I really worry about the broad ramifications that rule could have for all kinds of vaccines, including vaccines that are currently in the news and all kinds of effects that people are going to argue about that.

[00:32:21] Speaker 03:
I really see very little in the legislative history that suggests Congress intended that when it was talking about effects.

[00:32:29] Speaker 00:
Well, I mean, I can't talk about it.

[00:32:31] Speaker 03:
The only thing I see is when they talk about effects in any more detail in the legislative history is they're talking about disabilities and not diagnostic testing.

[00:32:41] Speaker 00:
I mean, I can't get into the coronavirus vaccine.

[00:32:44] Speaker 03:
I'm not asking you to, but you understand how broad the rule you're asking for is.

[00:32:49] Speaker 03:
It is not a narrow, fact-specific thing.

[00:32:53] Speaker 03:
It's almost any kind of condition that somebody has

[00:32:58] Speaker 03:
will often put them at higher risk for reoccurrence of that.

[00:33:01] Speaker 03:
And if just testing to make sure it hasn't reoccurred can bring you back into the table, then I think that vastly expands what Congress intended here, which is to compensate for disabilities resulting from vaccines, not this kind of testing.

[00:33:20] Speaker 00:
But if that testing is done near in time, as it was here within a year or two years of the fact that he suffered a table injury, and the experts agree on the fact that ITP is something that can reoccur.

[00:33:38] Speaker 00:
There can be chronic forms of ITP.

[00:33:41] Speaker 00:
I will note that one of the doctors who did these tests, one of those four tests in that two-year period after the six months, not only did the tests, she didn't even wait for the tests to come back.

[00:33:53] Speaker 00:
She ordered the petition to go back three hours away to the hematology clinic at Children's Hospital of Atlanta.

[00:34:00] Speaker 00:
That's page 66 of our record.

[00:34:03] Speaker 00:
I mean, when these doctors are doing these tests because, and only because,

[00:34:09] Speaker 00:
the child suffered a vaccine injury, then yes, that qualifies as a residual effect, much like Judge Bruging said it did.

[00:34:16] Speaker 00:
I'll just make one other point in response to your question, which is what does the congressional intent mean?

[00:34:24] Speaker 00:
The congressional intent, as Judge Bruging eloquently explained in his decision, is that the vaccine program is supposed to compensate children who generously, who are supposed to compensate them quickly,

[00:34:37] Speaker 00:
It's supposed to compensate children just like BW, children who've had an injury and an injury that the government acknowledges is based on the vaccine.

[00:34:49] Speaker 00:
And so you read this language in a more liberal fashion because it's a remedial statute.

[00:34:56] Speaker 00:
It's a compensation program.

[00:34:57] Speaker 00:
It's not typical litigation.

[00:34:59] Speaker 00:
It's a remedial statute.

[00:35:01] Speaker 00:
And I think it entitles the petitioner to a more

[00:35:05] Speaker 00:
you know, liberal interpretation of the statute.

[00:35:10] Speaker 00:
Again, the fact that he didn't have four tests that showed platelets is kind of immaterial.

[00:35:16] Speaker 00:
It was the fact that the vaccine injury caused the need for that testing.

[00:35:21] Speaker 00:
That testing wouldn't have been done.

[00:35:22] Speaker 00:
had he not had a vaccine injury that was conceded by the government, and that doctor would not have ordered him back to hematology for a hematology consult two years after he had, that six months had elapsed, had that doctor had not real concern about he might have recurrent ITP.

[00:35:48] Speaker 00:
If you have recurrent ITP, it can potentially be fatal.

[00:35:53] Speaker 00:
I mean, these doctors did the right thing because you can't send the child out to the parking lot and not do the testing when he has unexplained bruising.

[00:36:02] Speaker 00:
I mean, the record is full of things that he came in with bruising that was explained.

[00:36:08] Speaker 00:
He had a dog bite on his face.

[00:36:10] Speaker 00:
He fell off a grocery cart.

[00:36:11] Speaker 00:
He got his finger stuck in a car door.

[00:36:14] Speaker 00:
They didn't do the testing then.

[00:36:16] Speaker 00:
They only did the testing.

[00:36:18] Speaker 00:
When it was unexplained and he had petechiae and bruising on his body, that's why that doctor said, get down to Atlanta tomorrow.

[00:36:26] Speaker 00:
Drive the three hours and get your child checked out.

[00:36:28] Speaker 00:
That's two and a half years after the onset of his ITP.

[00:36:32] Speaker 04:
Mr. Miller, can I ask you, do you know in other areas of law, tort law over medical malpractice or whatever, does this phrase residual effects come up

[00:36:46] Speaker 04:
And obviously, if so, is there something to be learned from how that phrase is used?

[00:36:57] Speaker 00:
To be honest, I've not looked at other statutory schemes or other places in the law where that term comes up.

[00:37:02] Speaker 00:
To me, it is an issue of

[00:37:05] Speaker 00:
of plain meaning, that what it can't mean is that it is the disease itself that has to be present six months after the shot is given.

[00:37:16] Speaker 04:
But there's actually a middle ground, right?

[00:37:19] Speaker 04:
In the following sense, there can be a residual physical effect, bodily symptom,

[00:37:28] Speaker 04:
that might no longer be characterized as the initial injury, but is still a physical bodily effect that could still exclude mere, I don't mean to discount it, but mere diagnostic testing to see if there is any follow-on physical effect.

[00:37:56] Speaker 00:
Well, if it's related to the original event, I have a friend who's had cancer, bad prostate cancer.

[00:38:05] Speaker 00:
He had his prostate removed.

[00:38:06] Speaker 00:
But they require him every three months to go to Johns Hopkins and get PET scans to see if it's recurring.

[00:38:13] Speaker 00:
And they require him to do that for five full years.

[00:38:16] Speaker 00:
You know, he's had eight of those procedures.

[00:38:19] Speaker 00:
They showed nothing.

[00:38:20] Speaker 00:
But under the government's reading of the statutory language, that's not at all related to his prostate cancer.

[00:38:27] Speaker 00:
It's not related to his illness, injury, disability.

[00:38:29] Speaker 03:
The government's view is not that it's not related.

[00:38:31] Speaker 03:
It's not what that program intended to compensate you with a lump sum pain and suffering award for undergoing a disability.

[00:38:40] Speaker 03:
Your view would mean, I think, that any time you suffer a condition that requires testing,

[00:38:46] Speaker 03:
that's going to go on for years, then they're going to get that lump sum compensation award despite that six-month limitation.

[00:38:53] Speaker 03:
Because, of course, testing will occur after that six-month period.

[00:38:58] Speaker 00:
I can't see under that scenario how that would not qualify as a residual effect.

[00:39:04] Speaker 03:
It seems to provide a big loophole in Congress's decision to change it from one year back to six months when they were looking at conditions that resolve themselves quickly.

[00:39:15] Speaker 00:
Well, this is the language Congress gave us.

[00:39:17] Speaker 00:
I noted in the respondent's reply on the last page it talked about in 1995, the secretary wanted to give some guidance in a proposed rulemaking that he was going to make on ITP.

[00:39:31] Speaker 00:
But that's neither here nor there, because that can't trump

[00:39:36] Speaker 00:
Nor can the legislative history, with all due respect, Your Honor, can't truck the language that Congress actually gave us.

[00:39:42] Speaker 00:
This is the language Congress gave us.

[00:39:43] Speaker 00:
We're stuck with that.

[00:39:44] Speaker 00:
It was passed by both Houses of Congress and signed by the president.

[00:39:47] Speaker 00:
The secretary or anybody else can't change that at this point.

[00:39:50] Speaker 01:
OK.

[00:39:51] Speaker 01:
I think we've exceeded the time when we have your argument.

[00:39:54] Speaker 00:
Thank you.

[00:39:54] Speaker 01:
Thank you.

[00:39:55] Speaker 01:
We'll restore two minutes if you need it.

[00:40:07] Speaker 02:
Can we be very brief?

[00:40:09] Speaker 02:
I just wanted to address a point made that this is exceptionally rare that experts would agree.

[00:40:19] Speaker 02:
It's not exceptionally rare for the government to challenge the six-month sequelae issues in cases where they would otherwise meet the table.

[00:40:26] Speaker 02:
So I just wanted to make that point there.

[00:40:31] Speaker 04:
Can you use the change that Congress made from in 86 to 88

[00:40:37] Speaker 04:
Um, was there a change from one year to six months?

[00:40:42] Speaker 04:
I had thought that the change was that originally in 86, um, suffering for more than six months was one way you could get, have a compensable injury.

[00:40:53] Speaker 04:
Another was dying.

[00:40:54] Speaker 04:
And the third was a thousand dollars in expenses.

[00:40:58] Speaker 04:
And in 87, this.

[00:41:01] Speaker 04:
committee report, which I think is the one that you cite, said, no, that's too much.

[00:41:07] Speaker 04:
And so in 88, the statute was changed to say six months and $1,000 in expenses.

[00:41:17] Speaker 04:
Was there some six month to one year change?

[00:41:19] Speaker 04:
I just want to understand what that language could be.

[00:41:22] Speaker 02:
I'm afraid I'm not familiar with that there.

[00:41:26] Speaker 02:
I do want to state, though, to the extent you find the language ambiguous,

[00:41:31] Speaker 02:
This is a statute where the government has allowed private parties to sue them so that to the extent it is ambiguous, it must be construed narrowly in favor of the government.

[00:41:47] Speaker 02:
I think it's fairly clear from the argument that it is ambiguous and the language is not clear on its face.

[00:41:57] Speaker 02:
It's important to look at the legislative history, which does show, as Judge Hughes was showing, that there was the expectation that there would be ongoing disability, not simply testing, not simply possible symptoms of a disorder.

[00:42:11] Speaker 04:
Well, except this language, right?

[00:42:13] Speaker 04:
I mean, one thing that is a piece of language that maybe helps the other side is that the residual effect is an effect of injury, et cetera, disability doesn't itself have to be a disability.

[00:42:29] Speaker 04:
But it's still, I assume, based on the associated terms, whatever that Latin phrase is, printed canon of construction, it suggests that the residual effect, like complications, like injury, et cetera, is all about physical effects.

[00:42:48] Speaker 04:
But it doesn't have to actually be the very same disability, does it?

[00:42:52] Speaker 02:
it would need to be a residual.

[00:42:55] Speaker 02:
It would need to be an effect of.

[00:42:57] Speaker 02:
So I think, impartially, it had the medical definition, which wasn't just results from, but saying residual effects is something left behind.

[00:43:04] Speaker 04:
Why would a doctor say, you have to do this test.

[00:43:09] Speaker 04:
I wouldn't make you do it if you didn't have this past history if

[00:43:16] Speaker 04:
there was a lingering higher risk, namely, and that lingering higher risk must be, in some sense, physical.

[00:43:30] Speaker 02:
I'm sorry, your question is again, why would they have the testing?

[00:43:32] Speaker 04:
We have a case here, and this is the situation we're talking about.

[00:43:37] Speaker 04:
The doctor says you come in with a certain symptom, bruising here.

[00:43:43] Speaker 04:
I wouldn't

[00:43:45] Speaker 04:
do this test were it not for the fact that you once had this earlier injury.

[00:43:51] Speaker 04:
The reason I wouldn't do it otherwise and will now do it is that there's something about your body that now is different from what it would have been without the injury, namely a condition of the body presenting a higher risk of ITP.

[00:44:11] Speaker 04:
And that's why I'm going to do that.

[00:44:12] Speaker 04:
Why is that?

[00:44:15] Speaker 04:
a different higher risk body condition, not a residual effect?

[00:44:21] Speaker 02:
I don't think a risk of recurrence of a condition is what Congress intended when it said you need to suffer ongoing residual symptoms effect.

[00:44:33] Speaker 02:
And again, in the legislative history, it shows ongoing disability.

[00:44:37] Speaker 02:
I do not believe that incorporates

[00:44:40] Speaker 02:
the risk or a greater risk of having that condition in the future.

[00:44:49] Speaker 01:
Thank you.

[00:44:50] Speaker 01:
We thank both sides.

[00:44:51] Speaker 01:
The case is submitted.

[00:44:52] Speaker 01:
That concludes our proceeding.