[00:00:00] Speaker 02:
Our final case for argument is 23-1032, Lemming v. HHS.

[00:00:04] Speaker 02:
Mr. Crocknell, please proceed.

[00:00:09] Speaker 00:
Thank you, Your Honor.

[00:00:11] Speaker 00:
Good afternoon.

[00:00:12] Speaker 00:
May it please the Court.

[00:00:14] Speaker 00:
We're here because 15 months AL received an MMR vaccine.

[00:00:19] Speaker 00:
develop immune thrombocytopenic purpura, a serious disease, platelet disease.

[00:00:26] Speaker 02:
Okay, counsel, we know all of it.

[00:00:28] Speaker 00:
Okay, fine.

[00:00:28] Speaker 02:
So let's just move ahead, please, and why don't you focus on whether or not the surgery that your client experienced was a surgical intervention under the statute, and tell me why we should interpret the statute in a way that is different than the way it was interpreted below.

[00:00:47] Speaker 00:
Certainly, yes, Your Honor.

[00:00:49] Speaker 00:
Well, the way it was interpreted below is that it had all the earmarks of a surgical intervention.

[00:00:56] Speaker 00:
The decision of Chief Special Master Dorsey was reversed on a distinction that's extra statutory.

[00:01:04] Speaker 00:
It's not in the statute that that surgical intervention

[00:01:09] Speaker 00:
The key word intervention.

[00:01:10] Speaker 04:
So the key issue here is whether surgical intervention is limited to treatment or whether it could be diagnostic, which could lead to treatment, right?

[00:01:20] Speaker 04:
That's the issue.

[00:01:21] Speaker 00:
That's the issue.

[00:01:21] Speaker 04:
So why is it you're arguing, I think today, that surgical intervention should not be limited to treatment.

[00:01:27] Speaker 04:
Why is that?

[00:01:29] Speaker 00:
There's nothing in the statute that limits it to treatment, number one.

[00:01:33] Speaker 00:
But even if it were limited to treatment,

[00:01:36] Speaker 00:
The distinction here is not applicable under the facts.

[00:01:40] Speaker 04:
Well, just let me go back to the first issue.

[00:01:43] Speaker 04:
What do you focus on?

[00:01:46] Speaker 04:
What are you relying on to argue that surgical intervention is not limited to treatment?

[00:01:52] Speaker 04:
Is it the word intervention?

[00:01:54] Speaker 04:
Is it the surrounding words in the statute?

[00:01:56] Speaker 04:
Why don't you walk us through that statutory interpretation argument that you made?

[00:02:01] Speaker 00:
And as emphasized in Wright versus HHS and in the statute,

[00:02:06] Speaker 00:
intervention is for the benefit or the improvement of health.

[00:02:11] Speaker 00:
There's no reason why even a diagnostic procedure, and this was not purely diagnostic, it was to facilitate treatment, should be limited in that way, as interpreted by the court.

[00:02:24] Speaker 00:
And the court, the judge, relied strictly on dictionary definitions for that distinction.

[00:02:30] Speaker 00:
There's nothing in the statute

[00:02:32] Speaker 00:
that draws a bright line distinction between treatment and diagnosis.

[00:02:37] Speaker 04:
What is it that we're trying to figure out here?

[00:02:39] Speaker 04:
The severity, right?

[00:02:41] Speaker 04:
Severity?

[00:02:42] Speaker 04:
Exactly.

[00:02:43] Speaker 04:
How does treatment versus diagnosis have anything to do with severity?

[00:02:47] Speaker 00:
We would argue no.

[00:02:49] Speaker 00:
We would argue that the severity is inherent in the nature of the

[00:02:53] Speaker 00:
intervention in the surgical intervention that the child had to undergo.

[00:02:57] Speaker 04:
Well, there's other requirements in the statute, right?

[00:03:00] Speaker 00:
Well, there's a six-month requirement.

[00:03:04] Speaker 04:
Well, I meant surgical intervention and inpatient.

[00:03:07] Speaker 00:
Inpatient hospitalization.

[00:03:08] Speaker 00:
That's right.

[00:03:09] Speaker 00:
So we met.

[00:03:10] Speaker 00:
There's no dispute about inpatient hospitalization.

[00:03:13] Speaker 03:
It's conjunctive.

[00:03:14] Speaker 03:
I mean, you have to be inpatient and have surgical intervention, which means the hands or instruments of a surgeon have to

[00:03:21] Speaker 03:
be employed while you're inpatient.

[00:03:24] Speaker 03:
So if you went in for a diagnostic that was surgical as outpatient, it wouldn't be covered.

[00:03:29] Speaker 00:
But this was inpatient.

[00:03:30] Speaker 00:
Right.

[00:03:31] Speaker 03:
I'm just saying we're trying to interpret the statute, not the facts specific in this case.

[00:03:36] Speaker 00:
Absolutely.

[00:03:36] Speaker 00:
There's no dispute about that point.

[00:03:38] Speaker 03:
So it does limit

[00:03:40] Speaker 03:
Surgical intervention by the conjunctive you have to be inpatient and have surgical intervention and there's nothing you're arguing on the face of the statute that says that intervention has to be limited to Cure as opposed to even diagnostic.

[00:03:57] Speaker 00:
I think the relevant language is improvement of health There's no reason why it does diagnostic procedure.

[00:04:04] Speaker 02:
I need to know what your response is to Judge Piam's question and if you needed to

[00:04:08] Speaker 03:
So I'm inpatient and a surgeon is going to intervene.

[00:04:17] Speaker 03:
Whether it's diagnostic or treatment, which are two different things.

[00:04:22] Speaker 03:
One's going to potentially cure.

[00:04:23] Speaker 03:
The other one's going to help decide what path we're going to go down.

[00:04:27] Speaker 03:
It doesn't matter.

[00:04:28] Speaker 03:
As long as I'm inpatient and a surgeon is intervening, I would fall within the scope of the statute.

[00:04:33] Speaker 00:
That's our argument, certainly.

[00:04:35] Speaker 00:
But there's another argument, too.

[00:04:37] Speaker 00:
Even if it was a bright line distinction between diagnosis and treatment, we still would be within the meaning of the statute, because this intervention was to facilitate treatment, because the child had to go to school.

[00:04:50] Speaker 00:
So that's a fact-based.

[00:04:51] Speaker 00:
That's fact-based.

[00:04:51] Speaker 04:
And that's why- So we're just right now, for us as an appellate court, the most important thing for us to focus on is the interpretation question.

[00:04:58] Speaker 00:
Except it is relevant because Chief Special Master Dorsey found, as a matter of fact,

[00:05:04] Speaker 00:
that there was a blurred distinction.

[00:05:05] Speaker 04:
I just want to stick on this other issue for a minute.

[00:05:08] Speaker 04:
Are you aware of any medical dictionary or other dictionary or other source that uses the term surgical intervention?

[00:05:17] Speaker 00:
Not other than what's cited in the record.

[00:05:21] Speaker 04:
Because what we've got is we've got an interpretation of surgical and an interpretation of intervention.

[00:05:27] Speaker 04:
And I think everybody agrees that surgical is not limited.

[00:05:31] Speaker 04:
I mean, surgery could be for treatment, and surgical could be for treatment, or it could be for diagnosis, right?

[00:05:37] Speaker 04:
That's undisputed.

[00:05:38] Speaker 00:
That's undisputed.

[00:05:39] Speaker 04:
So somehow, the real question here is whether the word intervention

[00:05:43] Speaker 04:
in the context of the statute, somehow limits itself to treatment and ignores diagnosis.

[00:05:49] Speaker 00:
I think that's the issue before, the legal issue before the court.

[00:05:53] Speaker 00:
Agreed.

[00:05:54] Speaker 00:
And our argument is, and the relevant language here, forgive me for repeating myself, is for the benefit of health.

[00:06:01] Speaker 00:
So why is a diagnostic intervention that facilitates treatment not for the benefit

[00:06:07] Speaker 00:
of the health or improvement of the health of the patient.

[00:06:10] Speaker 04:
And I suppose that if Congress intended it to be treatment, they would have said surgical treatment.

[00:06:15] Speaker 04:
It might be one argument.

[00:06:15] Speaker 00:
Congress did not say anything about this, as Judge Kaplan herself said.

[00:06:20] Speaker 00:
There is almost no legislative history except for Judge Senator Jeffords' statement about intersusception.

[00:06:28] Speaker 00:
One senator spoke.

[00:06:30] Speaker 00:
Other than that, there's nothing in the legislative history that helps us.

[00:06:33] Speaker 02:
I want to follow up on one thing because you said yes to Judge Mingo's question and I want to make sure I understand because there was a presupposition in her question which I'm not sure is what I've seen fully fleshed out here.

[00:06:51] Speaker 02:
She suggested that you have to both be inpatient hospitalization and have a surgical intervention

[00:06:57] Speaker 02:
And I think I understood her question is tying those two things to the same moment in time or same event.

[00:07:04] Speaker 02:
And I think her question even may have suggested that therefore an outpatient surgical intervention wouldn't count.

[00:07:10] Speaker 02:
And let me ask, is that your view?

[00:07:12] Speaker 02:
Because when I read this statute, I don't see that.

[00:07:16] Speaker 02:
I see it requires inpatient hospitalization and it requires surgical intervention.

[00:07:21] Speaker 02:
And I don't see that this statute requires those two things are happening at the same time.

[00:07:26] Speaker 02:
So what if somebody went in the hospital for an inpatient hospitalization for a period of time, and then they were released and they were told to go and have an outpatient procedure?

[00:07:35] Speaker 02:
Are you saying that wouldn't count under the statute?

[00:07:38] Speaker 00:
It's a fair question.

[00:07:39] Speaker 00:
It's outside the confines of this case.

[00:07:41] Speaker 00:
We don't have that situation in this case.

[00:07:43] Speaker 00:
In this case, we have inpatient

[00:07:45] Speaker 00:
hospitalization and we have surgical and intervention.

[00:07:50] Speaker 00:
So the question of whether or not it's disruptive or conductive is really not presented.

[00:07:57] Speaker 02:
It's not disruptive.

[00:07:57] Speaker 02:
Disruptive would be the word or.

[00:07:59] Speaker 02:
This is not the word or.

[00:08:00] Speaker 00:
It's the word and.

[00:08:01] Speaker 02:
But the and could be you could have a patient that had both hospitalization

[00:08:04] Speaker 02:
and then also had a surgery that was performed outpatient, and that would seem to me to fall within the statute.

[00:08:09] Speaker 00:
In the appropriate case, I would certainly argue that as a petitioner's attorney.

[00:08:13] Speaker 02:
I mean, I don't know the answer, and you're right, since it's not presented to us in this case, maybe we don't have to answer that question.

[00:08:18] Speaker 04:
Your view is here, you've got it, for the same surgical

[00:08:21] Speaker 04:
procedure, it was an inpatient hospitalization at the time of the circus procedure.

[00:08:27] Speaker 00:
Yes, that's right.

[00:08:30] Speaker 00:
So I don't know if there are any more questions about that component of the case.

[00:08:34] Speaker 00:
We can go on to the second issue that was, in this case, a separate decision.

[00:08:40] Speaker 00:
After this court issued the right decision, it clarified for the first time what

[00:08:48] Speaker 00:
the severity provision of the Vaccine Act meant in the context of immune, ITP, immune thrombocytopenic corporeal.

[00:08:56] Speaker 02:
This is the big platelet argument?

[00:08:58] Speaker 00:
That's right, giant platelets.

[00:09:00] Speaker 02:
Did you say giant?

[00:09:03] Speaker 00:
No, that's what they're saying.

[00:09:04] Speaker 00:
Giant platelets.

[00:09:05] Speaker 00:
It was a blood smear.

[00:09:06] Speaker 02:
No, I get that.

[00:09:09] Speaker 02:
I wasn't big enough.

[00:09:09] Speaker 02:
I got it.

[00:09:12] Speaker 02:
Big platelets didn't get a job done.

[00:09:13] Speaker 00:
Big platelets.

[00:09:16] Speaker 00:
Um, Wright says that the key element is a somatic change within the body.

[00:09:25] Speaker 00:
And that's exactly what we have here.

[00:09:27] Speaker 00:
And it was detrimental because as petitioners expert explained that if you have giant platelets, that's a reaction to ITP and giant platelets don't adhere to the cell wall and can cause bleeding.

[00:09:41] Speaker 00:
And what we had here is bruising.

[00:09:43] Speaker 00:
Now, bruising alone, clearly underwrite, is not sufficient.

[00:09:47] Speaker 00:
But here we have a somatic change within the body that's related to bruising that was identified at the same point where the blood smeared.

[00:10:01] Speaker 04:
I am to understand that this is an alternative basis for arguing that you met the stability requirements, right?

[00:10:07] Speaker 00:
Yes.

[00:10:08] Speaker 00:
Thank you for asking.

[00:10:08] Speaker 00:
It's a completely separate basis.

[00:10:11] Speaker 02:
We need to find for you on this in order to find for you on the first issue.

[00:10:15] Speaker 00:
They're independent of one or the other.

[00:10:17] Speaker 02:
Because for me, my problem with this argument is that the special master in the court for the claims cited an enormous amount of evidence, position notes,

[00:10:27] Speaker 02:
from November of 2016, from December of 2016.

[00:10:31] Speaker 02:
And this is an arbitrary and capricious standard.

[00:10:35] Speaker 02:
And yes, you point to three pieces of evidence.

[00:10:38] Speaker 02:
But I am not the fact finder in the first instance.

[00:10:41] Speaker 02:
And as much as I like your argument in the first issue, I kind of don't love it on this issue.

[00:10:48] Speaker 02:
Because I feel like you're asking me to step into the role of fact finder.

[00:10:51] Speaker 02:
And you're asking me to do so when, quite frankly, there are a lot of position notes.

[00:10:56] Speaker 02:
A lot, lot, lot.

[00:10:58] Speaker 02:
which they cite, which seem to contradict your point here.

[00:11:00] Speaker 00:
Well, I think your honor is referring to the physician notes that say the conditions resolved.

[00:11:07] Speaker 00:
But those resolved medically, as we argued in our brief, is different from whether it's resolved or whether the condition is a lingering effect of the condition.

[00:11:19] Speaker 00:
That's the language.

[00:11:20] Speaker 02:
Physician note, December of 2016, three months post-vaccine, patient quote,

[00:11:24] Speaker 02:
patient continues to remain free of bleeding symptomology, no easy bruising, or, I don't know how to say that, that's a nice word, potentially, I'm not sure myself.

[00:11:32] Speaker 02:
Yeah, I'm sorry.

[00:11:33] Speaker 02:
So, I mean, that would seem to suggest that a lot of the symptoms that were the result of the giant platelets no longer exist three months post-vaccine.

[00:11:42] Speaker 00:
Then, then, but in July of 2017.

[00:11:46] Speaker 02:
In December 2016, AL is asymptomatic with normalized platelet count.

[00:11:53] Speaker 02:
patient-likeliness result at this time, and this is unlikely to reoccur.

[00:11:58] Speaker 00:
Yes, we don't dispute that record.

[00:12:01] Speaker 00:
What we are arguing is that in July of 2017, which was almost nine or 10 months after the onset, which would meet the six-month severity rule, that there was something abnormal that was shown in the blood smear.

[00:12:13] Speaker 00:
Blood smear can be used to diagnose ITP.

[00:12:16] Speaker 00:
The table injury defines ITP strictly in terms of low platelet count.

[00:12:21] Speaker 02:
So wait, so are you, is your argument that the board or the court of federal claims and the special master didn't err when they relied on all this evidence to conclude that potentially at month two and month three everything got better but yours then saying it then later got worse again or is your argument that it was bad all along and they were wrong to think it was better despite the evidence?

[00:12:44] Speaker 00:
Well, I think all we have to show is that there was a lingering effect after six months.

[00:12:48] Speaker 00:
We're arguing that there was a lingering effect of the ITP after six months.

[00:12:53] Speaker 00:
That meets the definition of the severity rule.

[00:12:57] Speaker 03:
That's our argument.

[00:12:58] Speaker 03:
Six months is somewhat arbitrary, but it's the time period they picked.

[00:13:02] Speaker 03:
And at the six month time period, the doctors found no residual effects.

[00:13:08] Speaker 03:
At least, that's what the record we have suggests.

[00:13:11] Speaker 03:
And then after that,

[00:13:12] Speaker 03:
there were, what you're arguing, are residual effects.

[00:13:15] Speaker 03:
The giant platelets were present.

[00:13:17] Speaker 03:
Now, again, I think Chief Judge Moore's argument was were they present before the six months and they missed it, which we don't have any record of, or this is something that reoccurred, but now you're outside the six month window and so you're just, it's too bad, so sad, but you're past the cutoff point.

[00:13:37] Speaker 00:
Well, I understand your concern.

[00:13:39] Speaker 00:
First of all, residual effects is a legal term.

[00:13:42] Speaker 00:
So no doctor found that there was no residual effect.

[00:13:46] Speaker 00:
They found, they used the word result, no symptoms.

[00:13:50] Speaker 00:
After the six months, however, there were symptoms.

[00:13:53] Speaker 00:
There was a lingering effect.

[00:13:55] Speaker 00:
And whether or not there were nothing found earlier, and there weren't blood smears done every time.

[00:14:00] Speaker 00:
So when the blood smear was done in July of 2017, that's when the lingering effect was detected.

[00:14:08] Speaker 00:
And there was a complaint from

[00:14:10] Speaker 00:
Ailes mother at that point of bruising now bruising alone as I mentioned earlier We have your argument and we want to save you some rebuttal time.

[00:14:18] Speaker 00:
Oh, thank you very much.

[00:14:19] Speaker 02:
So let's hear from the government.

[00:14:21] Speaker 02:
Ms.

[00:14:21] Speaker 02:
Collins?

[00:14:22] Speaker 02:
Collison, sorry, Collison?

[00:14:25] Speaker 02:
Did I get it right that time?

[00:14:26] Speaker 02:
Thank you.

[00:14:35] Speaker 02:
So let's jump right in council and start with the

[00:14:38] Speaker 02:
for legal interpretation of the surgical intervention language.

[00:14:44] Speaker 01:
Thank you, and may it please the court.

[00:14:46] Speaker 01:
Respondent still believes that distinguishing between surgical procedures that are diagnostic and for treatment, as Chief Judge Kaplan did, is a good way to ensure that Vaccine Act compensation is reserved for serious... That sounds like a purpose thing.

[00:15:01] Speaker 04:
What about that language, surgical intervention?

[00:15:06] Speaker 04:
should not cause us to think that it's intended to be, that it's limited to treatment.

[00:15:13] Speaker 04:
I'm having a hard time seeing it, so I want to hear your best argument.

[00:15:16] Speaker 01:
Chief Judge Kaplan explained that at appendix 18 in her living one decision.

[00:15:21] Speaker 01:
First, she looked to several dictionary definitions of the word intervention.

[00:15:27] Speaker 01:
In particular, she seized upon

[00:15:31] Speaker 01:
whether or not the surgical procedure affects, modifies, or prevents.

[00:15:36] Speaker 01:
And she determined.

[00:15:37] Speaker 04:
But that's a causation thing.

[00:15:38] Speaker 04:
Because obviously, if you're going to die and know somebody with a particular thing so that you know what treatment to take, you are going to affect.

[00:15:47] Speaker 04:
the injury, it's just not maybe immediate.

[00:15:50] Speaker 01:
Right, so she did several things in order to determine how to interpret surgical intervention.

[00:15:58] Speaker 01:
So she first looked at dictionary definitions, then she also looked at what the Special Masters had been doing to interpret this term in their own practice.

[00:16:12] Speaker 01:
She noted that several Special Masters, including Special Master Dorsey below,

[00:16:17] Speaker 01:
had wanted to make this distinction between diagnosis and intervention.

[00:16:24] Speaker 04:
What kind of basis for statutory interpretation, right?

[00:16:28] Speaker 01:
She took that into consideration in addition to looking at what surgical invention was intended to account for when it was added as a basis for meeting the vaccine section 11.

[00:16:42] Speaker 03:
It was a pretty narrow

[00:16:44] Speaker 03:
issue that came up from a vaccine thing when they added it.

[00:16:48] Speaker 03:
I mean, it should be interpreted as it's only in that particular instance where you need surgical intervention for this intestinal stuff that results from this vaccine, which I'm sorry, I can't remember the name of it at the moment, or as it's written more broadly, just a surgeon intervenes to do something.

[00:17:10] Speaker 01:
I think it's in between the two.

[00:17:13] Speaker 01:
The vaccine program has lived with the surgical intervention now since the year 2000 and has interpreted it certainly outside the bowel resection surgery for intersusception context.

[00:17:28] Speaker 01:
But pretty uniformly, the vaccine program has interpreted that surgical interventions need to

[00:17:37] Speaker 01:
be a stand-in for the type of surgery that was contemplated there.

[00:17:43] Speaker 01:
So it needs to, you know, be a stand-in for six months of sequela or death, which is the only two ways that you could have met the severity.

[00:17:51] Speaker 04:
Does it matter?

[00:17:52] Speaker 04:
How is it that treatment versus diagnosis, for example, in removal of the tumor for, in a brain tumor, how is it that

[00:18:04] Speaker 04:
treatment versus diagnosis somehow helps to understand whether it's severe enough, what the person is undergoing.

[00:18:12] Speaker 01:
I have two parts in response to your question, Judge Stoll.

[00:18:15] Speaker 01:
First, with respect to the particular circumstances here, I think it's extremely useful.

[00:18:21] Speaker 01:
The whole context of the government's motion for review here was because bone marrow biopsy is contemplated in the QAI for

[00:18:32] Speaker 01:
so contemplated in the definition.

[00:18:34] Speaker 01:
I don't think you're answering my hypothetical.

[00:18:37] Speaker 01:
Yes, I understand your hypothetical.

[00:18:38] Speaker 01:
Can you answer that for me?

[00:18:40] Speaker 04:
This interpretation that we are thinking about here is not just for the facts of this case.

[00:18:46] Speaker 04:
So I'd like you to address my hypothetical and tell me what work is diagnosis versus treatment doing in my hypothetical?

[00:18:53] Speaker 04:
Why is it that it's somehow showing whether something's more or less severe?

[00:18:58] Speaker 01:
So I think it matters very much in the distinction for this particular circumstances of this case, bone marrow biopsy in ITP.

[00:19:10] Speaker 01:
With regard to the hypothetical, I believe Your Honor is referring to page 502 of Judge Tapp's opinion in Flores, who he

[00:19:23] Speaker 01:
It expresses concern that the definition, a distinction between diagnosis and treatment, would leave out serious- I think it's a theory that a lot of your argument is telling me what the different judges think, and I was curious about what the government thinks.

[00:19:37] Speaker 04:
Right.

[00:19:38] Speaker 01:
So the government's position today is with respect to the facts at hand.

[00:19:43] Speaker 01:
It is concerning for us that bone marrow biopsy, which happens in nearly all ITP cases, would serve as

[00:19:53] Speaker 01:
would meet the severity requirement when, in 1995, when ITP was added to the table, you had to satisfy six months of sequelae or death in order to meet the severity requirement.

[00:20:06] Speaker 01:
And in fact, the notice of proposed rulemaking for ITP.

[00:20:08] Speaker 04:
So you're going to argue the facts to explain what my interpretation should be by ignoring the hypothetical.

[00:20:13] Speaker 04:
I'm sorry.

[00:20:14] Speaker 01:
Yes.

[00:20:14] Speaker 01:
Responding to the hypothetical, I disagree.

[00:20:17] Speaker 04:
That's what I'm going to do.

[00:20:20] Speaker 01:
Responding to your hypothetical brain biopsy, I highly, in such a circumstance, it would be very unlikely that such a case that required a brain biopsy would not meet the six months of QALA.

[00:20:36] Speaker 04:
OK, let's try this instead.

[00:20:38] Speaker 04:
What worked?

[00:20:40] Speaker 04:
is distinguishing between diagnosis versus treatment doing, with respect to showing how severe the surgery was.

[00:20:52] Speaker 04:
Because everybody agrees that surgery could be for treatment or diagnosis.

[00:20:57] Speaker 04:
So what work is it doing to say, well, it's for treatment, so it's more severe.

[00:21:02] Speaker 04:
Well, it's for diagnosis, it's less severe.

[00:21:05] Speaker 01:
I think it's an important question.

[00:21:08] Speaker 01:
It's a step, right?

[00:21:10] Speaker 01:
Most diagnostic procedures are less severe than a surgery that- I don't know that.

[00:21:17] Speaker 03:
I'm not a doctor.

[00:21:17] Speaker 03:
And this is why, in looking at the severity requirement, I read that conjunctiv is also temporally related.

[00:21:26] Speaker 03:
You're inpatient getting surgery.

[00:21:28] Speaker 03:
You're inpatient, OK, and at some other time, you're getting some surgical intervention that's diagnostic or treatment.

[00:21:37] Speaker 03:
but maybe not rising with the level of severity because it's being done outpatient.

[00:21:42] Speaker 03:
So Chief Judge Moore introduced this temporal issue on the and, which I had sort of in my mind saw them together in the way I read the statute, because it has to be severe.

[00:21:54] Speaker 03:
And so you're in the hospital and you're having surgery.

[00:21:58] Speaker 03:
there's going to be some level of severity to that, as opposed to, OK, show up at the doctor's office and get a biopsy or get some other treatment that requires some kind of surgery, but is not that severe, because you're going to go home in 10 minutes.

[00:22:13] Speaker 01:
The government certainly agrees with that interpretation.

[00:22:16] Speaker 01:
And I believe that that's what has been in practice in the vaccine program since 2000.

[00:22:21] Speaker 04:
And that's in Flores' breath, right?

[00:22:24] Speaker 01:
That's in Flores, although I will say that Judge Taft takes

[00:22:27] Speaker 01:
even more strict reading of the statute and says, actually, the bone marrow biopsy itself in Flores, as is actually the case in Lemming, did not require inpatient hospitalization.

[00:22:41] Speaker 01:
The child was hospitalized anyway for steroid therapy.

[00:22:49] Speaker 01:
And so in Flores, the child actually

[00:22:54] Speaker 01:
would not have met the severity requirement based on surgical intervention and inpatient hospitalization.

[00:23:00] Speaker 01:
In that case, the severity requirement was met based on six months of Zicola.

[00:23:10] Speaker 03:
It's just so complicated.

[00:23:13] Speaker 03:
It's going to be so fact specific because if you're inpatient,

[00:23:18] Speaker 03:
not because you need the surgical intervention, but you're inpatient for treatment and there's a surgical intervention, your argument may be that that is not a level of severity that would tie them together.

[00:23:29] Speaker 03:
But you could be inpatient and need the surgery all as one thing that would then rise to the level of severity, and then it all just becomes very case and fact specific.

[00:23:38] Speaker 01:
And I agree.

[00:23:40] Speaker 01:
Decisions are very context specific, and that's why I think this is the first time that the government has moved for review of a special master's decision interpreting the phrase, because in this particular circumstance in which a bone marrow biopsy, which is very common in the case of ITP, which often resolves within six months, we saw a pattern.

[00:24:08] Speaker 01:
There had been three cases in which

[00:24:10] Speaker 01:
special masters had determined, well, it's both diagnostic and intervention, so, you know, we'll meet the severity requirement there.

[00:24:20] Speaker 03:
Do you agree that intervention can be for diagnostic or treatment purposes?

[00:24:25] Speaker 03:
That the word intervention does not dictate it has to be for treatment.

[00:24:28] Speaker 03:
It could also be diagnostic.

[00:24:34] Speaker 01:
Yes, and I think the important part would be if it's treatment

[00:24:38] Speaker 01:
purpose, if there's a treatment element that you would meet the statutory definition, is the way that I'm reading Chief Judge Kaplan's decision.

[00:24:50] Speaker 03:
I'm asking you.

[00:24:51] Speaker 03:
The word intervention, I'm just going to intervene.

[00:24:56] Speaker 03:
And I may be intervening surgically to get a diagnosis, or I might be intervening surgically to treat you.

[00:25:04] Speaker 03:
And I don't see where there's the distinction here that I would say, oh, if it was simply to help diagnose and then lead to treatment, it's not covered.

[00:25:16] Speaker 01:
That's correct.

[00:25:19] Speaker 04:
What's correct?

[00:25:20] Speaker 04:
You're saying you agree that the term intervention includes both treatment and diagnosis?

[00:25:26] Speaker 01:
No, I'm agreeing that the term intervention would require something that affects, modifies, or prevents the particular vaccine injury.

[00:25:39] Speaker 03:
Well, effects and modifies would might be part of a treatment diagnosis to say, okay, we're going to go down this path instead of that path because now we've determined something else is going on here.

[00:25:52] Speaker 03:
Okay.

[00:25:53] Speaker 04:
Yes.

[00:25:53] Speaker 04:
I mean, we didn't do it directly, right?

[00:25:55] Speaker 04:
That's what I understand you to be doing.

[00:25:57] Speaker 04:
is that when you say an intervention has to directly lead to a two-step process.

[00:26:08] Speaker 04:
Correct.

[00:26:09] Speaker 01:
And I think that even Chief Judge Kaplan, I think even

[00:26:13] Speaker 04:
She used the word directly.

[00:26:17] Speaker 01:
As noted in footnote 8 of Chief Judge Kaplan's Lemming 1 decision at Appendix 19, the government argued below that we believed that the special master should also be afforded the opportunity to assess whether the

[00:26:42] Speaker 01:
effect of the surgical intervention or the surgical procedure, as it was, was of the magnitude contemplated by Congress akin to that undertaken to treat severe cases into deception or an equivalent stand-in, in other words, for six months of severity.

[00:26:59] Speaker 04:
So something you said earlier caught my ear, and what you said was that in this case that

[00:27:08] Speaker 04:
was in the hospital for reasons not related to the surgical procedure?

[00:27:18] Speaker 01:
That's correct.

[00:27:19] Speaker 01:
I mean she was in the hospital for treatment of her ITP which included IVIG infusion and the bone marrow biopsy was performed on October 4th in order to rule out leukemia so that they could start

[00:27:35] Speaker 01:
another treatment, which was IV steroids.

[00:27:40] Speaker 04:
And both IV steroids... Because the original treatment wasn't working, right?

[00:27:44] Speaker 01:
That's correct.

[00:27:45] Speaker 04:
And so in your view, I don't think there's a finding on this, but that the surgical procedure that was performed wasn't requiring an inpatient hospital stay?

[00:27:59] Speaker 04:
Are you saying that's...

[00:28:00] Speaker 01:
I mean, if you look at the record, you know, the anesthesiologist says, you know, OK to discharge home.

[00:28:05] Speaker 01:
But it's not in the record here.

[00:28:07] Speaker 01:
It was not.

[00:28:08] Speaker 01:
We did not appeal on the basis of there not being a sufficient patient hospitalization.

[00:28:14] Speaker 02:
OK, let's not go further.

[00:28:15] Speaker 02:
Thank you, counsel.

[00:28:16] Speaker 02:
Thank you.

[00:28:16] Speaker 02:
Mr. Greco, you have the floor.

[00:28:22] Speaker 00:
Thank you.

[00:28:23] Speaker 00:
Just a couple of points.

[00:28:24] Speaker 00:
I'm happy to answer any other questions.

[00:28:27] Speaker 00:
There is nothing in the statute that says the surgical

[00:28:30] Speaker 00:
intervention needs to be directly related to the underlying condition.

[00:28:36] Speaker 00:
Although here we would argue that it was directly related.

[00:28:38] Speaker 00:
But there's nothing in the statute that says that.

[00:28:40] Speaker 00:
There's nothing in the statute that points to any kind of distinction that was drawn by the chief judge.

[00:28:47] Speaker 00:
This distinction between treatment and diagnosis is nonexistent in the statute.

[00:28:52] Speaker 00:
We have to resort to dictionaries, to create a traditionally created distinction that doesn't apply.

[00:29:00] Speaker 00:
So that's one point.

[00:29:05] Speaker 00:
Again, the key element for the surgical intervention, with emphasis on intervention, is improvement of health.

[00:29:15] Speaker 00:
That's exactly why the surgical intervention was done.

[00:29:18] Speaker 00:
Also, I don't think it sounds like the issue of whether or not this procedure would have required an inpatient

[00:29:26] Speaker 00:
procedure is not really in this case, although we would argue that it is a severe procedure.

[00:29:32] Speaker 00:
There was a question about the severity.

[00:29:36] Speaker 00:
It is severe.

[00:29:36] Speaker 00:
It does require general anesthesia.

[00:29:39] Speaker 00:
It is invasive.

[00:29:41] Speaker 00:
It does require informed consent.

[00:29:42] Speaker 00:
These are all the factors that Chief Special Master Dorsey focused on when she determined that this was not purely for diagnosis, although even if it was, we would argue that it still met the definition of the statute.

[00:29:56] Speaker 00:
So there's nothing else I have.

[00:29:58] Speaker 00:
I'm happy to answer any other questions that the court has.