Shalala v. Whitecotton – Oral Argument – February 28, 1995

Media for Shalala v. Whitecotton

Audio Transcription for Opinion Announcement – April 18, 1995 in Shalala v. Whitecotton

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William H. Rehnquist:

We’ll hear argument now in Number 94-372, Donna E. Shalala v. Margaret Whitecotton.

Mr. Gornstein.

Irving L. Gornstein:

Mr. Chief Justice, and may it please the Court:

This case arises under the vaccine injury act and involves an interpretation of two related provisions.

The first creates a presumption that a vaccine has caused a child’s condition when the first symptom or manifestation of the onset of that condition occurs within a specified period after the administration of a vaccine.

The second permits the Secretary to rebut the presumption of causation by showing that the child’s condition is due to factors unrelated to the vaccine.

Our position is that the court of appeals erred in its interpretation of each of these provisions.

Let me start with the statutory presumption in section 300aa-11, which appears in page 2 of our brief.

The court of appeals interpreted the requirement that the first symptom or manifestation of onset must occur in the statutory period to mean that a presumption of causation will arise whenever any manifestation of a covered condition occurs after the administration of the vaccine, even if that condition has already manifested itself beforehand.

So under the court of appeals decision, if a child has very clear manifestations of a serious brain injury, and then has the vaccine, and then another manifestation of the same condition, under the court of appeals decision, there will be a presumption that the vaccine caused the onset of the child’s condition, and we think that interpretation is incorrect for two reasons.

First, it is inconsistent with the use of the statutory terms, first, and onset.

When a condition has already manifested itself prior to the administration of a vaccine, any manifestation of that same condition that occurs after the administration of the vaccine cannot be first, and it cannot be a manifestation of onset.

The very first symptom or manifestation of onset necessarily implied the absence of any preexisting symptom or manifestation of that same condition.

The second reason that we think the court of appeals erred in its interpretation is that its interpretation fails to take into account the fact that Congress specifically addressed cases where conditions had already manifested themselves prior to the administration of a vaccine through the significant aggravation presumption.

Under section 300aa-11, there is a separate presumption of causation when the first symptom or manifestation of a significant aggravation of a preexisting condition occurs within the statutory period.

We think the clear import of that separate presumption is that when a condition has already manifested itself prior to the administration of the vaccine, a presumption that the vaccine has something to do with the child’s condition can only arise when that preexisting condition has gotten worse after the administration of the vaccine.

So under a simple and straightforward reading of the statutory language, the simple existence of a symptom or manifestation of a covered condition in the statutory period is never enough by itself to trigger the presumption that the vaccine has caused the child’s condition.

In addition, it must either be the case that there’s no preexisting symptom or manifestation of that condition, or the child’s condition has gotten markedly worse afterwards.

By holding the court of appeals holding that the existence of a symptom or manifestation of a condition in the statutory period was sufficient by itself to trigger the statutory presumption, we think the court of appeals clearly erred.

Ruth Bader Ginsburg:

Mr. Gornstein, if we had only the language that was in that table and not the statutory language, wouldn’t there be more of a case for the opposite interpretation?

Irving L. Gornstein:

Justice Ginsburg, I think even if we were just looking at that table language, and that appears, by the way, at page 4 of our brief, and says,

“Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration. “

there would be more of a case, but I still think you would come to the same conclusion, because the words “first” are still used in relation to the term “onset” and I think when a condition has manifested itself prior to vaccine administration, anything that comes after that cannot be the first manifestation of onset.

Even trying to give some meaning to the word “first” in the table period is difficult, given the way the court of appeals interpreted that phrase, because if Congress had set out to do what the court of appeals had done, it wouldn’t have needed to use the word “first” at all.

It could have just said, any symptom after vaccine administration, because any symptom is always first in relation to what came… comes after the statutory period.

The only real reason to use the word “first” is to make clear that you’re talking about first in relation to what came before the statutory period.

But whatever ambiguity you have when you just look at this language, I think the bigger problem with what the court of appeals did is that it looked here at all, because the purpose of the Vaccine Injury Table is not to set out what the claimant is required to show in order to trigger the statutory presumption.

It’s set out to show the time period in which the claimant has to make that showing.

William H. Rehnquist:

Isn’t the term “first” somewhat superfluous with the term “onset”?

Irving L. Gornstein:

Well, I think you have the first symptom or manifestation of onset, or significant aggravation.

William H. Rehnquist:

So first doesn’t modify onset, in your view?

Irving L. Gornstein:

I think it… it does modify onset, yes, but I think it’s just first symptom or manifest… it’s somewhat superfluous, I would agree, but I think it makes it more clear.

It describes a relationship between “first” and “onset”.

So I think that that is the basic mistake, is in looking to the Vaccine Injury Table, because what… under section 300aa-13, it tells you that compensation is appropriate when the petitioner has demonstrated the matters in 300aa-11, and 300aa-11 is the part of the statute we’re relying on, which is very clear, and I believe even the court of appeals acknowledged that when you look at 300aa-11, it’s very clear that the claimant has to show, in effect, the first of all manifestations.

Sandra Day O’Connor:

Mr. Gornstein, if we were to agree with you on the interpretation of the statute as to question 1 in the cert petition, do we need to reach the question of the standards under question 2, as posed in the cert position?

Irving L. Gornstein:

You do not.

We have presented both questions because we think that in this case one or the other has to be suffic… there are two independent grounds, and either one will do.

Sandra Day O’Connor:

The respondent spends a good deal of time discussing how the district court might have reached the wrong conclusion on the facts here.

I assume all of those matters are open on remand.

Irving L. Gornstein:

We would agree that those matters are open on remand.

If there are no further questions on the first–

Antonin Scalia:

I have one.

What was the first symptom?

Irving L. Gornstein:

–The first symptom or manifestation was the abnormally small head size at birth, which was… the special master found was a positive indication that this child was… already had a very serious brain injury.

The second clear manifestation occurred at between 3 and 4 months, and that was the fact that she fell further behind on the growth chart in head size, and so that was also, the special master said, a manifestation that she had a preexisting brain injury, serious brain injury.

David H. Souter:

Is there any question in the record, just as an evidentiary matter, that the head size can be treated as a cause of the brain injury?

Irving L. Gornstein:

I would say it’s not the head size that’s the cause, it is the abnormally small brain that is the cause of the injury, and it is the abnormally small head size that tells you you have an abnormally small brain, and sometimes the term microcephaly is used to refer to both of those things, but what you have is an abnormally small head size that tells you you have an abnormally small brain, and that’s what the special master found.

David H. Souter:

So there’s no question about the evidentiary basis for that relationship.

Irving L. Gornstein:

No.

David H. Souter:

If we therefore reverse, there’s not going to be a fight over what the evidence shows.

Irving L. Gornstein:

Well, the other side may have a different view on whether the kind of… the head size here was sufficiently indicative of an abnormally small brain, the kind of abnormally small brain that would result in the conditions, and that was the dispute that was had at trial.

The special master resolved that by finding that there was sufficient evidence that it was so abnormally small as to indicate abnormally small brain that would give rise to these conditions.

David H. Souter:

You say there’s no question about the evidentiary basis for that finding.

Irving L. Gornstein:

I think that’s clearly supportable in the evidence.

The court of appeals did not disturb the special master’s findings on that, and in answer to Justice O’Connor’s question, I was simply saying that that is open on remand for them to argue that there’s something wrong with that finding.

We don’t think there is.

Ruth Bader Ginsburg:

Is the difference in the two briefs… you refer to a scientific term, and the plaintiffs refer to small head, not conceding that that was any kind of symptom of any malady.

Is that what the dispute–

Irving L. Gornstein:

I think that’s the factual dispute, that the head… they would agree, I believe, that at some point the head size is so small as to let you know that there is a real problem and that brain injury has already occurred, but they’ll have to speak for themselves on that issue, but I think what they would say is, it wasn’t small enough, and that the special master heard conflicting evidence about that and concluded that it was.

He also concluded… really, the main dispute was at birth, but there was really no… what was even clearer evidence is the further fall-off below the second percentile that occurred between the third and fourth month.

Irving L. Gornstein:

Even their expert agreed that that was an indication that some serious brain injury had occurred at 3 months, no later than 3 months.

It could have occurred at birth.

Anthony M. Kennedy:

–Well, let me ask you, and perhaps this will bring you to your second point, was it the hearing examiner’s theory… is it the Government’s theory that the ultimate condition, the encephalopathy, was related to the microcephaly?

Irving L. Gornstein:

Yes, that’s right, that the abnormally small brain led to the difficulties that this child later experienced in life, including mental retardation, and cerebral palsy, that these are, in fact, children with microcephaly, over 90 percent turn out to have… are mentally retarded.

There’s only a small percentage that are not.

Anthony M. Kennedy:

And is that the reason… or perhaps there are other reasons.

Is that the reason that the ultimate condition is not idiopathic?

Irving L. Gornstein:

The reason that the ultimate condition is nonidiopathic is that we take a different view of what that term means than did the court of appeals.

We think that what not idiopathic rules out is the Secretary saying something like, we know, we have evidence that the vaccine did not cause the child’s condition, but we have no idea what did.

The court of appeals took that one step further back and said, even if we can identify a factor that caused the child’s condition, we then have to go back and show what caused that factor, effectively requiring a dual layer of causation.

So it wasn’t enough for the Government to show that the small brain, abnormally small brain led to the child’s condition unless the Government can then go back and show what caused the child to have a small, abnormally small brain size in the first place.

Anthony M. Kennedy:

So are you saying that you can concede that the microcephaly is idiopathic, in the sense that we don’t know what caused it, but that you still prevail in this case?

Irving L. Gornstein:

That’s right, because I think idiopathic within the meaning of this statute simply… it describes a situation where the Secretary says, I have no… the vaccine couldn’t have caused it.

I have no idea what did.

That’s not this case.

The Secretary is saying, we know what caused the child’s condition.

It is the preexisting microcephaly, or abnormally small brain.

We just don’t know what caused that.

Anthony M. Kennedy:

So idiopathic depends on the question we’re asking, I take it.

Irving L. Gornstein:

That’s exactly right, and I think that to resolve that ambiguity I think you should go back to the core language in section 300aa-13, which says that the Secretary… (b), that shows that the Secretary can rebut the presumption of causation by showing that the child’s condition is due to factors unrelated to the administration of that vaccine.

When you just read that language, you definitely get the sense that the Secretary can rebut the presumption of causation by showing an alternative cause, but nothing in that would require the Secretary to establish the cause of the cause, and I think when you move down to the later references to idiopathic, you should… and unknown, you should read them in light of that basic distinction.

What must be known is the cause, not the cause of the cause, and the purpose of this idiopathic provision was to clear up an ambiguity that would otherwise have existed if they had just said, factors unrelated to the administration of the vaccine, because at that point it might have been the case that the Secretary could have said, I know the vaccine didn’t cause it.

I have evidence to prove it.

I don’t know what did, but a factor unrelated did.

Anthony M. Kennedy:

Does the medical profession use the word, idiopathic, in the same sense that we’re using it here, relative depending on which question we’re asking?

Irving L. Gornstein:

I think that’s right.

I can’t say that’s 100 percent true, but I think they would describe… they could easily describe it either way, depending on the question you’re trying to answer.

David H. Souter:

Does your under… does sense of idiopathic, as you are saying the statute uses it, broad enough to cover this situation: is a condition idiopathic when that condition is part of a recognized disease, in and of itself, although we don’t know what causes the disease?

For example, if you had a vaccine, one of the symptoms of which is people get… sometimes get forgetful after a couple of days, and someone with Alzheimer’s disease had the vaccine and was indeed forgetful.

We wouldn’t say, in effect, I suppose, that Alzheimer’s disease causes forgetfulness.

David H. Souter:

That’s what we mean by Alzheimer’s disease, so in that case, if the Secretary came in with evidence there was preexisting Alzheimer’s disease, would that be sufficient for rebuttal under your understanding of idiopathic?

Irving L. Gornstein:

As long as you could show that the Alzheimer’s preexisted the–

David H. Souter:

Yes.

Irving L. Gornstein:

–the administration of the vaccine, yes, because–

David H. Souter:

So nothing is idiopathic, then, I guess, if it is a condition which is sort of a recognized set of symptoms or conditions within normal diagnostic practice.

Irving L. Gornstein:

–That’s right, and cancer would be a good example.

If you had a preexisting cancer, and you knew that led to certain brain problems, mental retardation or whatever, even if the cancer was idiopathic in the sense that we don’t know what caused the cancer, it’s not idiopathic within the meaning of the statute, because it is a specific factor that the Secretary is relying on to explain the child’s condition.

The Secretary would not be saying in that case, I have no idea what caused this child’s condition.

The one other reason that I would give in support of our interpretation, other than the statutory language that I relied on, is that the court of appeals’ interpretation is really inconsistent with the purposes of the compensation program, because by adding a second layer of causation, they are really requiring compensation in cases in which everyone would agree that the vaccine could not have caused the child’s condition because something else did.

That is not consistent with Congress’ intent to limit compensation to vaccine-related injuries.

If the Court has nothing else, I’ll reserve the balance of my time for rebuttal.

William H. Rehnquist:

Very well, Mr. Gornstein.

Mr. Moxley, we’ll hear from you.

Robert Thomas Moxley:

Mr. Chief Justice, and may it please the Court:

On behalf of Maggie Whitecotton, we are not contending for a departure from the court of appeals decision, nor are we contending for a rule based on a generous interpretation of the statute, nor are we contending for an interpretation of the statute.

We are contending for an enforcement of the express language of section 300aa-13(a)(2)(A), found at page 3 of the petitioner’s brief, which states that the term

“factors unrelated to the administration of the vaccine. “

does not include any idiopathic, unknown, hypothetical, or undocumentable cause, factor, injury, illness, or condition.

On the subject of microcephaly, we do not believe that microcephaly qualifies as a first symptom of encephalopathy.

Microcephaly is the measure of the outside of the head at its largest point.

It’s not a measure of the function of the brain inside.

Any error in measurement is always in measuring it too small, because the largest part of the head is what the doctor looks for.

Microcephaly is not a diagnosis.

It is not a disease any more than short stature is a symptom of disease.

Ruth Bader Ginsburg:

Isn’t that a matter, counsel, for medical judgment, and weren’t there expert witnesses who testified that that was a manifestation, or symptom, of the ultimate disability?

Robert Thomas Moxley:

Correctly stated, no medical authority would consider it to be a symptom.

Correctly stated, a medical authority would consider it to be a finding, and to call it a symptom is to be sloppy in the use of the language.

Ruth Bader Ginsburg:

Well, what did the experts who testified in this case call it?

Robert Thomas Moxley:

I cannot recall, Your Honor, that experts ever called it a symptom, as such.

In the context of the statute, the statute prescribes what symptoms of encephalopathy are.

Robert Thomas Moxley:

The symptoms of encephalopathy are set forth extensively in section 14(b)(3)(A), the age and qualifications to the interpretation of the Vaccine Injury Table, and proof of an encephalopathy, in table time at least, or even outside of table time, under that statute is very narrow, and it focuses on specific medical findings such as EEG, such as bulging fontanel, it even says that the classical signs of a DPT reaction are compatible with but not proof of an encephalopathy, so–

Antonin Scalia:

Are they exclusive?

Are they recited to be exclusive?

Robert Thomas Moxley:

–They are not exclusive, but I don’t believe–

Antonin Scalia:

So what difference does it here whether it’s called a symptom or anything else?

As I understand it, the finding below was that there was a pathological condition of the brain which was evidenced by the small head size, if you like, but–

Robert Thomas Moxley:

–That is correct–

Antonin Scalia:

–but that there was that pathological condition before the vaccine was administered, and that’s what needs to be proven, isn’t it?

Robert Thomas Moxley:

–Well, what we believe this Court should do is articulate a rule which will guide us in our practice, and we believe the enforcement of the plain language of the statute sets forth a sequence of analysis that must be performed.

We believe that what the special master did was skipped a step in the sequence.

The sequence in the statute is first, 13(a)(1)(A), and then 13(a)(1)(B).

13(a)(1)(A) first calls for the inquiry as to whether or not the petitioner has proven a table case.

In this case, the proof of this case, in the Government’s proof of this case, the Government used the table reaction as part and parcel of the proof of the preexisting condition, and the special master skipped over the table reaction to get into the causation inquiry before the special master made the findings that give us the benefit of the presumption.

William H. Rehnquist:

But that wasn’t the basis for the court of appeals ruling, was it?

Robert Thomas Moxley:

In a very strong sense, Your Honor, I believe it is.

William H. Rehnquist:

Well, the court of appeals… I understood the court of appeals to leave the findings of the special master undisturbed.

Robert Thomas Moxley:

I agree that that happened, although the special master did violence to the statute, and the court of appeals was able to determine the case in that… because of that legal error.

We believe the court of appeals said what they can’t do, but we believe that this Court should set forth a rule telling us what they can do, and we believe that the proof–

William H. Rehnquist:

Are you defending the reasoning of the court of appeals here?

Robert Thomas Moxley:

–Oh, very much so, Your Honor.

William H. Rehnquist:

Well, but since the court of appeals dealt virtually not at all with the findings of the special master, I don’t see why you should concentrate on the findings of the special master, then.

Robert Thomas Moxley:

Oh, I don’t so much focus on the findings, Your Honor, as the process which the special master went through, and the special master skipped over the finding of the table injury.

The special master found, parenthetically, as it were, that technically the petitioners had put on a table case.

Our strongest argument is that the statute requires a focus on the table time injury.

As implied by our statement of the questions presented, we believe that the Secretary must prove through a logical sequence of cause and effect that the so-called factor unrelated can be shown as the cause of the table injury.

In this case, the special master’s analysis was whether or not the so-called factor unrelated was consistent with the ultimate outcome.

We believe it would be legally and logically inconsistent to allow the Government to use the same facts which give rise to the presumption to also defeat the presumption, and the Government syllogism of causation in this case was that this child had to have an organic brain syndrome because this child had a small head, and this child had seizures, and this child had cerebral palsy, et cetera.

Antonin Scalia:

Well, let’s look at (a)(1)(A).

That’s what you say was not adequately done.

It requires a showing of the matters required by section 300aa(11)(c)(1).

Antonin Scalia:

Where is that?

Robert Thomas Moxley:

11(c)(1) is the statute found at page 4 of the petitioner’s brief.

11(c)(1) merely sets forth the requirements of the petition that–

Antonin Scalia:

The bottom of page 4, Vaccine Injury Table, is that what you’re talking about?

Robert Thomas Moxley:

–No, it… the requirements of the petition.

The… 11(c)(1)(C)(i) says a petition shall contain documentation.

William H. Rehnquist:

Where are you reading from, Mr. Moxley?

Robert Thomas Moxley:

I… the statute is on page 3, I’m sorry.

William H. Rehnquist:

Page 3–

Robert Thomas Moxley:

Of the petitioner’s brief.

William H. Rehnquist:

–of the petitioner’s brief, thank you.

Robert Thomas Moxley:

Page 2.

Page 2 is section 11.

It says, the petition shall contain documentation that the person who suffered such injury sustained or had significantly aggravated any illness set forth in the Vaccine Injury Table, and the first symptom or manifestation of the onset or significant aggravation occurred within the time set forth in the table.

Now, it’s–

Antonin Scalia:

And it goes on, and the first symptom or manifestation of the onset or of the significant aggravation of any such illness, disability, blah, blah, blah, blah, blah.

Robert Thomas Moxley:

–Yes.

Now–

Antonin Scalia:

Don’t leave that out.

That’s central to the case, isn’t it?

Robert Thomas Moxley:

–Well, the thing that… I agree, yes, Your Honor.

The matter that is central to the case is that what happened to Maggie Whitecotton in table time is the onset of a table condition, a residual seizure disorder.

Antonin Scalia:

Well, but that’s the debate.

I mean–

Robert Thomas Moxley:

Well, the special master–

Antonin Scalia:

–you simply just can’t say that the special master ignored that provision.

Robert Thomas Moxley:

–The special master found, Your Honor, that the child technically, “technically” satisfied the provisions of the table with regard to a residual seizure disorder.

That is, the child’s first seizure occurred in table time.

Antonin Scalia:

But–

Robert Thomas Moxley:

That has to be the onset of a significant aggravation.

Robert Thomas Moxley:

As a matter of law, a table injury, ab initio, in table time, has to be something that satisfies the table.

Antonin Scalia:

–But the illness is not the seizure.

Surely the seizure is a manifestation of an illness, isn’t it?

Is the seizure the illness?

You ask what his illness is, he has–

Robert Thomas Moxley:

The encephalopathy, the acute encephalopathy–

Antonin Scalia:

–All right.

Robert Thomas Moxley:

–was the injury, Your Honor, yes.

Antonin Scalia:

All right, and what this requires is that the first symptom or manifestation of the onset or of the significant aggravation of the illness have occurred within the period after the vaccine–

Robert Thomas Moxley:

Yes, Your Honor, but–

Antonin Scalia:

–was administered.

Robert Thomas Moxley:

–A residual seizure disorder–

Antonin Scalia:

And that’s what the debate is about.

Robert Thomas Moxley:

–A residual seizure disorder is a table injury and it is a specific table injury, and it is a specific species of table injury, and it’s also the most specific well-known species of vaccine injury.

Sandra Day O’Connor:

But counsel, the special master found that the child had not, in fact, suffered a residual seizure disorder, and you didn’t petition for cert on that.

I didn’t think that was before us here.

The CA Fed has not addressed that, has it?

I just didn’t think that argument was even here.

Robert Thomas Moxley:

Your Honor, I believe the CA Fed recognized that the seizure, under the statute, was clearly the onset, the first onset of symptomatic encephalopathy, and I believe that’s a correct holding.

Sandra Day O’Connor:

Yes, but you were just arguing this residual seizure disorder point, and I understood that that issue was not here.

It was decided against you by the special master, and it isn’t here.

Robert Thomas Moxley:

The special master did say that the child suffered a residual seizure disorder.

The special master said that the child doesn’t now suffer from a residual seizure disorder.

What that doesn’t take account of, Your Honor, is the fact that a residual seizure disorder and an encephalopathy are overlapping definitions, and the residual seizure disorder is in the table to satisfy by itself the requirements of the table to show a table time encephalopathy.

The CA Fed showed that the child… held that the child had suffered a table time encephalopathy, and I don’t think anybody factually disputes that.

William H. Rehnquist:

Did the special master hear medical evidence?

Robert Thomas Moxley:

The special master did, Your Honor.

The special master synthesized his findings from the literature, and we submit that they are not the type of finding to be given deference by an appellate court because they are logically absurd on their face.

If 90 percent of the children with this head size had seizure disorders–

William H. Rehnquist:

But to repeat Justice O’Connor’s point, my impression was the findings simply are not here.

Robert Thomas Moxley:

–I agree that we’re not arguing–

William H. Rehnquist:

But you keep criticizing them.

Robert Thomas Moxley:

–I understand that, Your Honor.

Our–

Anthony M. Kennedy:

You agree, I take it, that there can be different kinds of symptoms evidencing the same cause, right, evidencing the same disease.

A disease can have more than one symptom, right?

Robert Thomas Moxley:

–Many manifestations, yes, Your Honor.

Anthony M. Kennedy:

Now, suppose that a symptom of encephalopathy occurred before the administration of the vaccine.

Robert Thomas Moxley:

Yes, Your Honor.

Anthony M. Kennedy:

The presumption would not be satisfied then, would it?

Robert Thomas Moxley:

I… no, I don’t agree with that, Your Honor, because–

Anthony M. Kennedy:

All right.

I think that’s what we’re here to argue about.

Robert Thomas Moxley:

–Yes.

The issue… the issue–

Anthony M. Kennedy:

And I think it would assist the Court if you would argue that point, because that’s where you’re in disagreement with the Government, and that’s why the case is here.

Robert Thomas Moxley:

–Yes, Your Honor.

The issue is whether or not an acute encephalopathy occurs within table time.

If the child has a preexisting condition, the focus is whether or not that acute encephalopathy radically changes that child’s future prognosis.

If the encephalopathy does radically change that child’s future prognosis, that child has had a significant aggravation.

There is no way to trigger the significant aggravation presumption other than to have an acute encephalopathy in table time, and the sudden onset of seizures in table time, and the diagnosis in the record by the treating physicians of a DPT encephalopathy, satisfies that burden whether or not the child had a preexisting condition.

David H. Souter:

Well, it’s necessary to satisfy the burden, but it’s not sufficient to satisfy the burden, because you’ve also got to show that it was… that these symptoms were the manifestations, the first manifestations of the onset of the disease, and that in and of itself doesn’t follow merely from introducing evidence that after the vaccination the symptoms occurred.

You’ve got to introduce something else, haven’t you?

Robert Thomas Moxley:

I don’t exactly agree with that, Your Honor.

The issue is… is whether or not the disease, the alleged disease necessarily includes the symptoms.

All are in agreement that the alleged organic brain syndrome which allegedly preexisted the table time reaction, all are in agreement that the table time reaction is not typical of organic brain syndrome.

All are in agreement that seizures are not typical of organic brain syndrome.

All are in agreement that cerebral palsy is not necessarily a manifestation of organic brain syndrome.

David H. Souter:

Well, they may not be typical, but if in fact the evidence is that they were caused, and you don’t also introduce some evidence to the effect that there was no other manifestation of the disease prior to vaccination, you haven’t touched all the bases required in the statute, have you?

Robert Thomas Moxley:

I believe that… I believe it gets back to 13(a)(2)(A).

David H. Souter:

Well, what’s the answer to my question first?

Robert Thomas Moxley:

The answer is that there was… that microcephaly is not a disease.

Microcephaly might be a symptom of a disease.

Chronic organic brain syndrome is not a disease, either.

It is an idiopathic disorder.

It is totally speculative.

David H. Souter:

Well, no one is claiming in this case that microcephaly is itself the disease.

I mean, I… maybe I’m missing your point–

Robert Thomas Moxley:

I believe the Government has.

David H. Souter:

–but I don’t think that responds either to the Government’s position or to my question.

Robert Thomas Moxley:

I believe, Your Honor–

David H. Souter:

I thought the disease was encephalopathy, and the Government is simply saying that… well, I… strike what the Government is saying.

It seems to me that in order to make the case that you have to make in the first instance, you would have to show not merely that there was some manifestation, some symptoms of that following the vaccination, but that in fact it was the first symptom, that it was the symptom of an onset, and if you don’t show that, you haven’t, in fact, made out your prima facie case, isn’t that so?

Robert Thomas Moxley:

–I don’t believe that it has to be the first symptom in a significant aggravation case.

The legislative intent has a specific… fact-specific example in it of the aggravation of a seizure disorder, and all it requires is that the seizures become more frequent, so the first–

Ruth Bader Ginsburg:

Let’s say it’s not a… let’s leave aside the aggravation point.

If you’re just talking about the first symptom of the illness, then you would agree that you must show not only that there was a symptom within the table time after the vaccination, but that it was the first symptom.

Robert Thomas Moxley:

–That is correct for what we call an onset case, Your Honor, yes.

I don’t dispute that at all.

John Paul Stevens:

Your position is that this is an aggravation case, is that correct?

Robert Thomas Moxley:

Our position is that this case satisfies the table presumption for significant aggravation.

John Paul Stevens:

So that if I understand you correctly that even though there might have been a symptom of the disease before the vaccination, therefore it’s not… therefore what happened after the vaccination is not the first symptom of the onset, nevertheless, I understand your position, there could be a serious aggravation caused by the vaccine, and the first symptom of that was the seizure within 3 days.

Robert Thomas Moxley:

That is correct, Your Honor.

The–

John Paul Stevens:

So that if there… but that’s not the theory of the court of appeals, or am I right on that?

Robert Thomas Moxley:

–Well, it’s both.

Our theory is that we had actually the first symptom of an encephalopathy as defined by the act in table time after the shot.

John Paul Stevens:

You make two arguments.

1) you say the small head size is not a symptom.

Robert Thomas Moxley:

Yes.

John Paul Stevens:

That’s one of your arguments.

And alternatively you argue, under the table, that the seizure within 3 days, or whatever the period was, was the first symptom of a serious aggravation.

Robert Thomas Moxley:

That is correct, Your Honor.

John Paul Stevens:

So you have two alternative arguments.

Robert Thomas Moxley:

That is correct.

Antonin Scalia:

What did the finder of fact conclude as to that?

Robert Thomas Moxley:

The finder–

Antonin Scalia:

I mean, surely that’s a factual question.

Robert Thomas Moxley:

–The finder of fact found that we technically fit the table, but that maybe Congress did not intend for the table to be literally applied.

Ruth Bader Ginsburg:

Can you point to the words in the finder of fact’s findings that say what you’ve just summarized?

Robert Thomas Moxley:

There is a footnote.

One would have to look in the petition for writ, and have to look for the special master’s decision.

Page 27a of the petition for writ of certiorari.

The special master found that the child’s condition satisfied the injury table but that he did not have to find a table injury, and footnote 4, he said his conclusion was based on a literal reading.

However, Congress may have intended something else.

We believe that we need a rule that will govern us in our practice.

We believe that we need a rule which puts the burden on the Government after we satisfy our burden, and does not put a burden on us to disprove the Government’s case in the satisfaction of our burden.

Stephen G. Breyer:

If you need a rule, I mean, I thought this case came here on a slightly different theory.

Imagine a baby is born.

On the 3rd February it has a seizure.

On the 3rd March, it has another seizure.

On the 1st April it gets some DPT vaccine, and on the 3rd, it has a third seizure.

In that circumstance, I thought the statute makes clear that you have not… will not be able to recover.

Robert Thomas Moxley:

It doesn’t–

Stephen G. Breyer:

You were not able, in that situation, to show what, I guess, the statute here in 11(c) requires, that you have to show that… what are the exact words, that the first symptom or manifestation of the injury or the aggravation occurred within 3 days after the DPT vaccine.

Robert Thomas Moxley:

–I agree, Your Honor.

Stephen G. Breyer:

And yet the Fed Circuit seemed not to do that simple thing.

Rather, they seemed to say that even if it were just the case I was describing, that that words wouldn’t apply.

That’s what I thought the issue was initially, and then that seems to be mixed up with a different issue, is, is this small head size like the prevaccine seizures or not like the prevaccine seizures?

You’re saying not, it wasn’t a symptom or manifestation, and I guess initially the other side said it was.

Stephen G. Breyer:

Am I right?

Robert Thomas Moxley:

You are.

Stephen G. Breyer:

If not, explain why I’m not.

Am I… I am right?

Robert Thomas Moxley:

The thing that would have to be–

Stephen G. Breyer:

I’d like to be right.

Robert Thomas Moxley:

–Yes, Your Honor.

The thing that would have to be added to your significant aggravation scenario–

Stephen G. Breyer:

Yes.

Robert Thomas Moxley:

–in order for us to satisfy our case to show… our burden to show a table case would be for that seizure after the shot to be the first of weekly seizures.

Stephen G. Breyer:

There’d have to be some change.

In the pure case that I imagine, everybody’s in agreement.

Is that right?

Robert Thomas Moxley:

I believe so, yes.

Stephen G. Breyer:

And so then the question is, was it somehow an aggravation, a symptom of a significant aggravation, the first symptom of a significant aggravation–

Robert Thomas Moxley:

Yes, Your Honor.

Stephen G. Breyer:

–and if so, the statute seems to say, if it’s the first symptom of the significant aggravation… that’s what… the words it uses, then, if you show that, you prevail, but then what’s the legal argument?

They’re saying, and as it comes up here, it seems as if there is a finding that it isn’t the first symptom of a significant aggravation.

There was a disease here that preexisted, and there was no significant change.

Those are fact-findings.

Robert Thomas Moxley:

Your Honor, in the… there’s a legal standard there that’s implicit.

The Office of Special Masters has articulated a presumption of normalcy for the child at the time of the shot if the child has had no overt symptoms of encephalopathy, and if you’ll look at the Government’s reply brief, they would put the burden on us of proving that the child was normal at the time of the shot, and we believe that we need an articulation of what this statute means in terms of what it means to our practice, and we believe that the Court should find that this child has the right to be presumed to be normal if she had no symptoms of encephalopathy that fit the statute–

Stephen G. Breyer:

Well, what the statute says, the statute says that you, the petitioner, have to demonstrate by a preponderance of evidence matters in the petition, in 300aa(11)(c)(1).

One of those matters is that the first symptom or manifestation of the significant aggravation occurred within 3 days after the DPT vaccine, so it would seem to say that you have to show that.

So why wouldn’t it?

Robert Thomas Moxley:

–Well, the first symptom does not require a showing that the child was normal.

The first symptom is the first symptom.

The seizure in this case was, indeed, the first symptom.

There were no symptoms.

Microcephaly is not a symptom.

Antonin Scalia:

Mr. Moxley, may I come back to Justice Ginsburg’s question about what the finder of fact had to say about aggravation?

You referred us to page 27a, and footnote 4.

I have read it now three times, and I find not a word about aggravation.

It says nothing about aggravation.

Robert Thomas Moxley:

The special master went into the question of comparing the ultimate condition, consistency of ultimate conditions.

Antonin Scalia:

This is the closest you can find to a finding by the special master that this was a significant aggravation–

Robert Thomas Moxley:

No, Your Honor.

Antonin Scalia:

–Page 27a.

Robert Thomas Moxley:

No, Your Honor.

Antonin Scalia:

Well, give me another page.

Robert Thomas Moxley:

That is the–

Antonin Scalia:

I don’t find a mention of aggravation on page 27.

Robert Thomas Moxley:

–I agree.

I–

Antonin Scalia:

Well then, why did you cite that page in response to Justice Ginsburg’s question?

Robert Thomas Moxley:

–I believe that she was asking me if I was… if I could point out whether or not the Court had addressed the issue of a table injury, Your Honor.

Antonin Scalia:

I thought it was aggravation.

Robert Thomas Moxley:

I believe that–

Antonin Scalia:

Well, I’ll ask you.

Aggravation.

What did the–

[Laughter]

What did the finder of fact have to… you’re contending this was an aggravation.

Where did the finder of fact find an aggravation?

Robert Thomas Moxley:

–The finder of fact used the Massoci test as articulated… as ostensibly argued in my brief, which was to compare the ultimate condition of the speculative… compare the ultimate condition to the outcome from the speculative organic brain syndrome.

Because the special master focused on the final outcome rather than on the table injury, the special master was able to find that the causation of the ultimate outcome was from the speculative hypothetical preexisting condition.

Antonin Scalia:

I think what you’re saying is, not at all.

Robert Thomas Moxley:

Not at all, properly.

That is correct, your Honor.

Antonin Scalia:

Not at all, that the finder of fact did not find any aggravation.

Robert Thomas Moxley:

No.

He addressed aggravation at page 36a–

Antonin Scalia:

Ah.

Robert Thomas Moxley:

–of that same… in that same opinion.

Antonin Scalia:

All right.

Robert Thomas Moxley:

A comparison of the condition prior to the administration of the vaccine and an exercise of deciding whether or not that condition was consistent with the current condition.

If you believe that the child is brain-injured prior to the shot, there’s a way of saying that the ultimate condition is always consistent–

William H. Rehnquist:

Where on 36a does the special master talk factually about aggravation?

Robert Thomas Moxley:

–I don’t believe the special master did.

I don’t believe the special–

William H. Rehnquist:

Did the special master anywhere make any factual finding that there was an aggravation?

Yes or no.

Robert Thomas Moxley:

–No.

He found that there was no aggravation.

The issue to us is whether or not the table condition itself is an aggravation, and the special master’s analysis is whether or not the ultimate condition is an aggravation, and we believe that it strips us of the statutory presumption of compensability–

Ruth Bader Ginsburg:

Mr. Moxley, in answer to the question that was asked, I think that there was something the fact-finder said.

He said… this is on page 43a…

“no significant aggravation of Maggie’s underlying brain disorder was manifested within 3 days following the administration of the DPT vaccine. “

so he made a finding that there was no significant aggravation.

Robert Thomas Moxley:

–I agree, Your Honor.

I believe that the onset of a residual seizure disorder in the–

William H. Rehnquist:

Mr. Moxley, we’ve been questioning you several times about findings of aggravation.

You answered me just a moment ago that the special master made no finding.

Now Justice Ginsburg points out that he made a very express finding.

How can you stand up there at the rostrum and give these totally inconsistent answers?

Robert Thomas Moxley:

–I’m sorry, Your Honor.

I don’t mean–

William H. Rehnquist:

Well, you should be.

Robert Thomas Moxley:

–I don’t mean to confuse the Court.

William H. Rehnquist:

Well, you… perhaps you haven’t confused us so much as just made us gravely wonder, you know, how well-prepared you are for this argument.

Robert Thomas Moxley:

Your Honor, it is our assertion that the onset of a residual seizure disorder in table time is a significant–

William H. Rehnquist:

Your time has expired.

Robert Thomas Moxley:

–aggravation as a matter of law.

Thank you, Your Honor.

William H. Rehnquist:

Mr. Gornstein, you have 11 minutes remaining.

Irving L. Gornstein:

Just two ouick points.

One is that the court of appeals did not reach the question of significant aggravation.

It decided this case as an onset case, and that’s clear from page 5a of our… to the petition for a writ of certiorari, where they quote the language from the table that refers to onset.

John Paul Stevens:

It is correct, is it not, that your opponent does rely in part on it being an aggravation case?

Irving L. Gornstein:

Yes, and I was going to say that the special master found that there was no significant aggravation.

There is a discussion of the evidence in support of that.

John Paul Stevens:

The theory of the special master was, you compare the condition at the time of the vaccination with the condition in the long run, as I understand it.

Irving L. Gornstein:

I would say that that wa part of the analysis.

John Paul Stevens:

And your opponent’s argument is that the seizure itself was an aggravation, isn’t that right?

Irving L. Gornstein:

That’s their theory, and I–

John Paul Stevens:

And that’s what the table… that’s the theory of the table under his view of the statute.

Irving L. Gornstein:

–His theory was that the seizure was the manifestation of a significant aggravation, and the special master addressed that and said that it wasn’t because the seizures were very brief and transient, that after the seizures in the table period, that the child returned to her prevaccine neurological status, that she continued to progress at the basically kind of slow but sure pace, and that she ultimately–

John Paul Stevens:

Is it correct that the seizure… as to the first seizure the child had?

Irving L. Gornstein:

–That is the first seizure the child had, yes.

John Paul Stevens:

So at least there’s an argument that hasn’t been resolved by the courts below as to whether that might itself satisfy the requirements of the table.

Irving L. Gornstein:

Well, two of the three courts below resolved it, but the court of appeals did not.

John Paul Stevens:

Right.

Irving L. Gornstein:

I would say the special master in the Court of Federal Claims, and that issue is open on remand–

Stephen G. Breyer:

Yes.

But Mr. Gornstein I think has raised a point which he’d like guidance on in this, because suppose that this child has the seizure within 3 days after the DPT vaccine is administered, and suppose that really is the first seizure, and the purpose of this statute is so you don’t have to go into a long thing about causation, you don’t have to go into a long thing about whether there was some other, mysterious thing that caused it.

Well, you could, on your interpretation, have to go into that long thing, because if mysterious disease X that nobody knows about in fact had caused something, arguably, prior to the administration of the vaccine, like a head-twisting, or something, then it would be open to the Government to say, oh, you see, that was really the first symptom, in which case by the back door you’d bring in all these other mysterious, idiopathic or whatever, causes.

I think… I’m not positive, but I think that’s the kind of thing that was bothering him, and I think that that’s the sort of thing he’d like an interpretation about, so what would we say about that?

Irving L. Gornstein:

–I’m not sure I follow the hypothetical.

Stephen G. Breyer:

Well, I mean, there’s a mysterious idiopathic cause, some weird thing, and the Government wants to say, this weird thing is the cause.

Irving L. Gornstein:

Okay.

Irving L. Gornstein:

I–

Stephen G. Breyer:

Now, they’re forbidden by the statute to bring that up, but they might say, wait a minute, there was a first symptom.

The first symptom was a neck-twisting or something–

Irving L. Gornstein:

–Well, I think–

Stephen G. Breyer:

–even before.

Irving L. Gornstein:

–Well, I think there has to be medical evidence that–

Stephen G. Breyer:

Yes, there is.

There’s a doctor who comes in and–

Irving L. Gornstein:

–to say that that is a manifestation of encephalopathy, and if that’s true, then the child has not demonstrated the prima facie case, and then you turn to the question of significant aggravation, and you look to see whether the seizure is a manifestation of something that, a marked change in the condition for the worse.

Stephen G. Breyer:

–You could bring that in even with the weird, mysterious, idiopathic mystery disease?

You see, that’s what’s worrying him, the weird, idiopathic mystery disease which had its first symptom, according to Dr. X, before the vaccine was administered.

Irving L. Gornstein:

You could, but I’m not sure I see what the problem with that is, when the statute, the terms of the statute say that the claimant has to show that the first symptom or manifestation of encephalopathy occurred after a vaccine administration.

And if there is a preexisting manifestation of encephalopathy, and there is medical evidence to that effect, it’s just that we don’t know what caused the encephalopathy, then there’s no presumption, because the natural… the natural implication of the evidence is that the child already had something, and then the statute says you look to whether there’s significant aggravation.

David H. Souter:

May I–

–Mr. Gornstein, assume… I’m sorry.

Just… I want to follow up one point on the aggravation.

Supposing that it is true that if 3 days after… within 3 days after an aggravation, the child has the first seizure the child has ever had, and at that point in time, that would be one symptom of a serious aggravation.

Now, it may turn out, over… if you look at it a year later that there never was a serious aggravation.

This would have happened anyway.

But is it not true that looking at it as of the period 48 hours after the vaccination, the table condition is satisfied if it is a symptom of something that she may, in fact, not have?

Irving L. Gornstein:

I think that what the statute says is it has to be a manifestation of a significant aggravation, which means–

David H. Souter:

No, it has to be a symptom.

Irving L. Gornstein:

–A manifestation of a significant aggravation.

David H. Souter:

Right.

Irving L. Gornstein:

And the… but the significant aggravation is defined–

John Paul Stevens:

It’s a symptom or a… a first symptom or manifestation, or of the significant aggravation.

It seems to me that… it seems to me, in other words, the statute could be satisfied by someone who’s perfectly healthy, if they had the wrong symptom.

Irving L. Gornstein:

–If it was a… if someone could say, testify, based on that manifestation, that that was a manifestation of a marked deterioration in the child’s condition, because significant aggravation is defined on page 6 of our brief, 300aa(33)(4), the term significant aggravation means any change for the worse in a preexisting condition which results in markedly greater disability, pain, or illness, accompanied by substantial deterioration of health.

So you have to be able to say that that seizure was a manifestation of that.

That is, that it was a manifestation of a change for the worse in a preexisting condition which results in markedly greater disability, pain, or illness, and the special master carefully examined that and found that it was not.

Irving L. Gornstein:

Seizures can be entirely benign.

They can be something that is a manifestation of significant aggravation.

They can be a manifestation of something in between benign and significant aggravation.

John Paul Stevens:

It seems to me if they’re a symptom, that’s all the statute requires, and that’s what you’re opponent argues here in his alternative theory.

Irving L. Gornstein:

On significant aggravation?

John Paul Stevens:

Yes.

Irving L. Gornstein:

Well, I think it has to… I would repeat my argument that it’s not enough for it to be a symptom.

It has to be a manifestation or a symptom of a significant aggravation.

John Paul Stevens:

But manifestation is in the dysjunctive, compared to symptom, symptom or manifestation.

Irving L. Gornstein:

That’s right, and it was… the special master found it was neither in this case.

David H. Souter:

My I try out two alternatives–

Irving L. Gornstein:

Sure.

David H. Souter:

–to see if I understand your position.

Assume Justice Breyer’s hypothetical.

The first seizure occurs whatever it was, a day after the vaccination.

Prior to the vaccination there has been head-twisting, neck-twisting of some sort.

The medical evidence, the Government presents medical evidence in the first case, the first hypothetical, by a doctor who says, in my judgment there probably was a relationship between the seizure and the preexisting neck-twisting.

That is not a standard syndrome, but I think that’s what we’re ultimately going to find, so for that reason I posit a cause of the seizure which is not the vaccination.

That’s hypothetical number 1.

Hypothetical number 2, the doctor says, there is in fact a recognized syndrome or condition in which seizures and neck-twisting go together.

You get neck-twisting, you know you’re going to get a seizure or there’s going to be a high probability of a seizure later on.

This conjunction of symptoms is readily observed and understood as kind of a standard diagnostic category, and we call that category disease X. Disease X has nothing to do with vaccinations.

You would have gotten the seizure anyway because you had the neck-twisting.

As I understand your position, in the first case, the claimant would have made out at least a case for the presumption.

It would not have been affected by this hypothesis of an idiopathic cause which nobody but the doctor testifying knows about.

In the second case, the presumption would not apply, because, in fact, no reasonable finder of fact would conclude, if they accepted the doctor as telling the truth and as a competent medical expert, no reasonable finder of fact would… in fact would conclude that this… that the seizure was, in fact, a first manifestation of an aggravation.

Is that your position?

Irving L. Gornstein:

Justice Souter, I’m not sure I agree with that description.

David H. Souter:

Okay.

Well then, correct me then.

Irving L. Gornstein:

I think that as long… in the first case, even if you don’t know what caused it, if you can say, this is a manifestation of encephalopathy, and that is the table condition that the claimant is seeking compensation for, and the person doesn’t know exactly–

David H. Souter:

Well, you mean, even if you don’t know what causes encephalopathy–

Irving L. Gornstein:

–That’s right.

David H. Souter:

–but there is always seizures that go with encephalopathy–

Irving L. Gornstein:

But that–

David H. Souter:

–and you have evidence of preexisting encephalopathy.

Okay.

Irving L. Gornstein:

–But that’s the key, is encephalopathy, because that’s what the table says you can recover for, either the onset of encephalopathy, or a significant aggravation of encephalopathy.

That’s the key condition, and so when you go back and say, what happened before table time, the question you’re asking under the first part of our analysis is, was there a symptom or manifestation of encephalopathy, not of head-jerking, or anything else.

It could be… you get nowhere with head-jerking.

On the second part of our analysis, if you could show that head-jerking is some sort of defined condition that causes, ultimately, encephalopathy, then you would win as a… on a factor unrelated, even if the first symptom or manifestation of that condition occurred after the administration of the vaccine, and that’s the difference between our two theories.

David H. Souter:

What about the residual seizure disorder point?

I thought it was decided by the master that that was not established.

Irving L. Gornstein:

That’s right.

The special master found that there was not a residual seizure disorder because the… one of the requirements is that the effects last for a period of more than 6 months, and the special master found that that was not so with respect to residual seizure disorder.

William H. Rehnquist:

Thank you, Mr. Gornstein.

The case is submitted.