[00:00:00] Speaker 01:
This morning is Pat Catfield versus Secretary of Veterans Affairs 2023-2280.

[00:00:38] Speaker 03:
Good morning, your honors.

[00:00:40] Speaker 03:
May it please the court.

[00:00:42] Speaker 03:
Adam Luck, appearing on behalf of appellant Pat A. Hatfield.

[00:00:47] Speaker 03:
This case involves Ms.

[00:00:48] Speaker 03:
Hatfield's allegation of clear and unmistakable error in her 1980 board decision.

[00:00:53] Speaker 03:
And it presents the primary issue of whether a breach of the duty imposed on VA medical personnel in 1976 to obtain informed consent prior to rendering medical treatment

[00:01:04] Speaker 03:
constituted compensable negligence at the time of her 1980 board decision.

[00:01:09] Speaker 01:
Well, that wasn't part of the statute in 1980.

[00:01:13] Speaker 03:
Well, Your Honor, in 1980, as well as when it was enacted back in 1924, Section 351, as noted by the Veterans Court, was intended to

[00:01:31] Speaker 03:
Afford veterans compensation for disability that arises through accident, carelessness, negligence, lack of proper skill, similar sense of fault, et cetera.

[00:01:40] Speaker 03:
on the part of any person charged with a duty respecting hospitalization or medical treatment.

[00:01:44] Speaker 03:
Now, how do we know who has a duty?

[00:01:47] Speaker 03:
How do we know what those duties are or the standard of those duties?

[00:01:49] Speaker 03:
That came in 1976, Your Honor, with the enactment of Section 4131 and then later when VA promulgated Section 1734.

[00:01:58] Speaker 01:
Well, this is a cue case, clear and unmistakable error.

[00:02:04] Speaker 01:
So you're sort of arguing inferences and pulling in other things.

[00:02:07] Speaker 01:
That's not clear and unmistakable error.

[00:02:10] Speaker 03:
Well, Your Honor, I think because it's complex doesn't necessarily mean it's undebatable.

[00:02:16] Speaker 03:
What is undebatable here is that Mr. Hatfield's treating physicians in 1978 had a duty to obtain his informed consent.

[00:02:25] Speaker 03:
It was a statutory and regulatory duty to obtain informed consent, to document that consent, to inform him of the risk of the procedures he was undergoing.

[00:02:34] Speaker 03:
And it's undisputed that his informed consent was not obtained.

[00:02:37] Speaker 03:
We know that from Appendix 99.

[00:02:39] Speaker 03:
The Secretary conceded that on page 3 of his brief.

[00:02:43] Speaker 03:
We also know it's undisputed that Section 351 was directed at any VA personnel charged with a duty.

[00:02:51] Speaker 03:
So when Congress enacted 4131, charging VA medical personnel with a duty to obtain informed consent, that brought that personnel under the umbrella that Section 351 was intended

[00:03:03] Speaker 03:
to compensate veterans for whenever there's a breach of those duties.

[00:03:07] Speaker 04:
You don't contest, as I understood your brief, that there has to be a showing that the action was negligence, right?

[00:03:18] Speaker 03:
At the time of

[00:03:20] Speaker 03:
of when 351 was enacted, there was no requirement of 351 as a causation.

[00:03:26] Speaker 03:
Right.

[00:03:27] Speaker 04:
But the regulations that were promulgated under 351 from way back required negligence, as I understand those regulations.

[00:03:36] Speaker 04:
Correct.

[00:03:37] Speaker 04:
And as applicable to this case, isn't it your burden here to show that it was clear and unmistakable that negligence

[00:03:48] Speaker 04:
of the sort that's covered by 351 and the regulations included failure to obtain informed consent.

[00:03:57] Speaker 03:
Correct, Your Honor.

[00:03:57] Speaker 03:
So section 351 essentially says that if disability or death results from VA treatment,

[00:04:07] Speaker 03:
Section 3.358, the regulation you're referring to from way back when, was the proximate cause regulation requiring that the resulting disability or death be due to something like negligence, carelessness, lack of proper skill, et cetera.

[00:04:20] Speaker 03:
And Ms.

[00:04:20] Speaker 03:
Hatfield's argument is that the failure to obtain informed consent, the breach of the duty imposed by 4131 in 1734, was that negligence action, that proximate cause.

[00:04:35] Speaker 04:
The law, as I understand it at the time in 1980, was in the process of moving from characterizing lack of informed consent as a battery, a form of battery, in towards saying that it could be negligence.

[00:04:53] Speaker 04:
But that was a process that was in flow.

[00:04:59] Speaker 04:
It had not yet been achieved clear.

[00:05:03] Speaker 04:
an understandable status as a form of negligence.

[00:05:07] Speaker 04:
Is that a fair characterization of where the law was at that time?

[00:05:10] Speaker 03:
Fair characterization from a medical standpoint, Your Honor.

[00:05:13] Speaker 03:
So I guess some states obviously recognize that as a battery.

[00:05:21] Speaker 03:
Some states recognize it as negligence.

[00:05:24] Speaker 03:
In Texas, for example, where Mr. Hatfield was treated, recognized it as negligence.

[00:05:30] Speaker 03:
But the duty

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The breach of the duty is the negligent action.

[00:05:34] Speaker 03:
That's what we're arguing here, Your Honor, is not necessarily that there's this widespread acceptance in the medical community, or even a standard of informed consent.

[00:05:44] Speaker 03:
But there's a regulatory and a statutory duty that was imposed on VA to comply with what VA has conceived as a longstanding requirement to obtain informed consent.

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with that breach of that duty that brings it under the umbrella.

[00:06:00] Speaker 03:
That's the connection between the duty imposed and the compensation for the breach of the duty imposed under 351.

[00:06:07] Speaker 02:
I had understood your answer to one of Judge Bryson's earlier questions to be you agree that we would have to find that as of 1980, it was undebatable

[00:06:19] Speaker 02:
that not only informed consent or lack of informed consent was negligence, but that it was compensable negligence under the statutory and regulatory regime in place in 1980.

[00:06:29] Speaker 02:
We'd have to find that's undebatable in order for you to prevail here.

[00:06:34] Speaker 02:
All of that, including the compensable nature of the harm here.

[00:06:38] Speaker 02:
Are you agreeing that that is what we'd have to find?

[00:06:40] Speaker 03:
I do agree.

[00:06:42] Speaker 02:
So what authority can you cite on the compensable point that by 1980 it was undebatable as a legal matter under federal law that a veteran was entitled to compensation for this type of negligence?

[00:07:00] Speaker 03:
So the board and the Veterans Court, everyone's looking for this smoking gun.

[00:07:05] Speaker 03:
Point to one specific thing that says,

[00:07:10] Speaker 03:
Yes, breach of informed consent equals negligence.

[00:07:13] Speaker 03:
But what Hathfield is arguing is it was well recognized in 1980 that a breach of the duty imposed constituted negligence under 4131 and 1734.

[00:07:25] Speaker 03:
And that brought that negligence, the breach of the duty, within the realm of 351 and 3.358.

[00:07:33] Speaker 03:
Does that make sense?

[00:07:38] Speaker 02:
It makes sense, but I guess the question is, have we said, I don't know that we've said clear and unmistakable error when you're alleging it's a legal interpretation like this, that it necessarily requires a precedential finding of a court at the time.

[00:07:56] Speaker 02:
But I think we've at least suggested it requires something more than just

[00:08:02] Speaker 02:
an interpretation that you just gave of various statutes and regulations that may be right or may be wrong, but it's hard for me to see how it's undebatably right.

[00:08:11] Speaker 03:
Well, what has not happened in this case is the board has not addressed that, and the Veterans Court has not addressed that.

[00:08:16] Speaker 03:
What the board addressed is whether the express link between informed consent and compensation that came in regulation 3.361 was present prior to 2004.

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And the board said it wasn't, because this came in 3.361.

[00:08:33] Speaker 03:
The Veterans Court said the same thing.

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It said, in 1924, lack of informed consent was not even contemplated.

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And it wasn't contemplated until 1995, when Section 3.361 first began its process, its road to promulgation.

[00:08:50] Speaker 03:
But we know that that is incorrect.

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And how do we know?

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It's because in 1994, VA's general counsel issued a presidential opinion that links failure to obtain informed consent

[00:09:01] Speaker 03:
with the conversation provided under 351 and 3.358.

[00:09:07] Speaker 03:
So neither the board nor the Veterans Court mentioned this VA general counsel opinion.

[00:09:15] Speaker 03:
But what is notable about that opinion is it came before section 3.361's express link.

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So it confirms there's already a link in place between failure to obtain informed consent

[00:09:26] Speaker 03:
and compensation under 351 and 3.358.

[00:09:30] Speaker 03:
So the whole board's reasoning that 361's express consent was not available prior to 2004 is clearly incorrect.

[00:09:42] Speaker 03:
And when the Veterans Court talks about we're able to look at the law to interpret what was there or what was missing,

[00:09:54] Speaker 03:
prior to 1980, we've got to talk about all the law.

[00:09:57] Speaker 03:
And the Board nor the Veterans Court talked about that, which clearly show there is a link there.

[00:10:03] Speaker 04:
But in 1994, general counsel opinion, even if you take that opinion as expressing clear law at that time, it's 14 years after the events that this case turns on.

[00:10:17] Speaker 04:
So it doesn't seem to me a natural inference to say, well, if the general counsel said in

[00:10:23] Speaker 04:
1994 that this is a compensable injury.

[00:10:26] Speaker 04:
It must have been so in 1980.

[00:10:27] Speaker 04:
That's my problem with the general counsel argument.

[00:10:31] Speaker 03:
Understood, Your Honor.

[00:10:32] Speaker 03:
The relevance of the 1994 VA general counsel opinion is, A, like we just discussed, that it contradicts the board's reasoning for denying Ms.

[00:10:44] Speaker 03:
Hatfield's claim.

[00:10:46] Speaker 03:
It contradicts the Veterans Court's citation that consent hadn't even been mentioned until afterwards.

[00:10:53] Speaker 03:
But it also supports Ms.

[00:10:55] Speaker 03:
Hatfield's interpretation of her allegation of Q in that there was a duty imposed on VA, and VA breached that duty when it treated Mr. Hatfield and caused his death without obtaining informed consent.

[00:11:10] Speaker 03:
That's where Mrs. Hatfield's reliance on the 1984 general counsel opinion comes.

[00:11:19] Speaker 02:
sent us the supplemental authority of our decision recently in cycles.

[00:11:24] Speaker 02:
Are you still maintaining that something improper was done here by citing to post-1980 legal developments?

[00:11:34] Speaker 03:
Well, Your Honor, so obviously the footnote in cycles pretty much telegraphs this court's position on considering subsequent authority to interpret laws that stood under the relevant time.

[00:11:49] Speaker 03:
Ms.

[00:11:50] Speaker 03:
Hatfield may disagree with that, but that's the law that we have today.

[00:11:53] Speaker 03:
So I don't think that's no longer an issue that we will continue to pursue.

[00:12:03] Speaker 01:
Do you want to save the remainder of your time for a bottle?

[00:12:08] Speaker 03:
Yes, Your Honor.

[00:12:09] Speaker 01:
You can entirely use it.

[00:12:11] Speaker 03:
Absolutely.

[00:12:12] Speaker 01:
Thank you.

[00:12:13] Speaker 01:
Mr. Golden.

[00:12:32] Speaker 00:
Good morning, and may it please the court.

[00:12:36] Speaker 00:
First, just to address the obvious, what happened with Mr Hatfield was an undeniable tragedy.

[00:12:41] Speaker 00:
And as the board said in 1980,

[00:12:44] Speaker 00:
there's deep sympathy for Mrs Hatfield, and there's obviously the Board wishes that a different outcome had occurred.

[00:12:50] Speaker 00:
But as to this case today, as the Court correctly noted, the question is not whether or not some other regulation regarding developing doctors' practices mentions informed consent.

[00:13:03] Speaker 00:
The question is what did the statute regarding compensation

[00:13:07] Speaker 00:
say in 1980 regarding when compensation was eligible and when did they speak to informed consent.

[00:13:14] Speaker 00:
I do want to address one point that opposing counsel made regarding Appendix 99 and page 3 of the government brief which he qualified as an admission that there was no informed consent.

[00:13:23] Speaker 00:
Just to be clear, documented informed consent is the exact language that was used in that situation.

[00:13:29] Speaker 00:
It wasn't regarding the potential of informed consent

[00:13:32] Speaker 00:
In the appendix, there are actually letters from Mrs Hatfield from the 1970s that refer to radiologists talking to her and her husband discussing a 95% chance of successful treatment.

[00:13:43] Speaker 00:
Obviously, we wish that had been the chance that it happened.

[00:13:46] Speaker 00:
But that goes to the application of laws to facts, and that was for the board to do.

[00:13:51] Speaker 00:
Sitting here today, the question for this court is, did the Veterans Court, as a matter of law,

[00:13:57] Speaker 00:
in its decision affirming the board's decision not the question of was there the factual question and application of Q error to the 1980 decision that was a decision that the board made.

[00:14:11] Speaker 00:
So based on that, we point to the fact that, as the court has noted, there is conflicting evidence.

[00:14:18] Speaker 00:
We used to be cited to some states that had decisions in the 1970s and the 1980s that found that there was no negligence for lack of informed consent.

[00:14:30] Speaker 00:
And here we're looking at what the board was assigned in 1980 and putting ourselves in their shoes at the time they were making the decision.

[00:14:36] Speaker 00:
And I think one critical thing here is to look at that board's decision in the appendix.

[00:14:40] Speaker 00:
specifically on pages 53 through 55, where the board sought an independent medical expert and specifically asked the question, was the veteran's care at the VA center otherwise within the bounds of accepted medical practice?

[00:14:55] Speaker 00:
And they received a response from the independent medical examiner, who was the head of oncology at Albany University Medical School.

[00:15:02] Speaker 00:
The plan was fully appropriate.

[00:15:05] Speaker 00:
in this patient the complication of treatment was suspected early, diagnosed correctly and treated properly.

[00:15:12] Speaker 00:
As to the question as to whether there was clear error that the board should have somehow in 1980 looked beyond an independent medical expert and its own medical experts who both found the treatment was done properly, looked beyond that decision to look for not whether there was informed consent but whether there was a documented informed consent despite no statutory or regulatory language telling them to do so.

[00:15:35] Speaker 00:
I don't think we can stand here today and say that no reasonable final fact would have acted the way the board did today, that it was clear, unmistakable error.

[00:15:43] Speaker 04:
The regulation on informed consent, setting aside the statute regarding 351 regarding compensation, I thought that had been prior to 1980, right?

[00:15:56] Speaker 00:
The regulation regarding the direction of the VA to develop methods of obtaining informed consent.

[00:16:01] Speaker 00:
I see.

[00:16:02] Speaker 04:
There was not a regulation.

[00:16:04] Speaker 04:
dictating exactly how that was to be obtained?

[00:16:08] Speaker 04:
Is that what you're saying?

[00:16:08] Speaker 00:
So that comes into the VA's interpretive regulation, which did also come into effect, I believe, between the time of Mr. Hatfield's treatment and the board's decision.

[00:16:19] Speaker 00:
But again, that goes to the question of how do VA medical practitioners obtain and document this consent?

[00:16:26] Speaker 00:
It doesn't go to compensation.

[00:16:27] Speaker 04:
And did that interpretive regulation say the informed consent must be documented?

[00:16:32] Speaker 00:
i would need to look at the exact language at the time.

[00:16:34] Speaker 00:
I don't remember if it said documented or it just said obtained.

[00:16:37] Speaker 00:
I would have to double check that one.

[00:16:39] Speaker 00:
But what I would say is that language said nothing to, and if you don't do this, then we go to section 351, then we go to compensation standard.

[00:16:47] Speaker 00:
In fact that's why we eventually have to have 3.361.

[00:16:53] Speaker 00:
Why that language has to come in and say

[00:16:56] Speaker 00:
And remember, this is in 3.361D1, there are two subsections that say that a veteran needs to get compensation when their medical treatment leads to further disability or death.

[00:17:07] Speaker 00:
The first one speaks to the VA failing to exercise the degree of care, and that's what opposing counsel was talking about, that lack of informed consent fell to a lack of degree of care.

[00:17:18] Speaker 00:
But the second section is the one that says,

[00:17:21] Speaker 00:
that the VA furnished the care without the veterans or the veterans' representatives' informed consent.

[00:17:29] Speaker 00:
It is a separate reason, separate from the failure for degree of care.

[00:17:35] Speaker 00:
The lack of informed consent is an entirely distinct, even in the statute today, reason why you'd get compensation.

[00:17:44] Speaker 04:
in the regulation.

[00:17:45] Speaker 00:
In the regulation, thank you.

[00:17:46] Speaker 04:
And when was that regulation, remind me, when was that promulgated?

[00:17:49] Speaker 00:
I believe it was suddenly far after 1980.

[00:17:52] Speaker 00:
I can't remember the exact date it came into play, but that's the regulation.

[00:17:55] Speaker 04:
Somewhere in the 1990s.

[00:17:56] Speaker 00:
I feel like that 1997, I think, might have been.

[00:17:59] Speaker 04:
So shortly after the OGC's

[00:18:05] Speaker 00:
I want to double check before making any insertion to that point.

[00:18:08] Speaker 00:
But that is the regulation that's now been applied to Mrs. Hatfield's renewed claims.

[00:18:13] Speaker 00:
This is the reason why, as of 2021 and back dated to 2010, she is receiving compensation for what happened to Mr. Hatfield.

[00:18:21] Speaker 00:
That's the decision that's in the appendix right at the end.

[00:18:25] Speaker 00:
Not the queue decision, the reopened decision.

[00:18:28] Speaker 00:
Because now 3.361 does exist.

[00:18:32] Speaker 04:
And that goes back how far?

[00:18:33] Speaker 00:
I was back in 2010 which is when her claim was re-entered.

[00:18:36] Speaker 04:
So she wants now to recover between 1980 and 2010.

[00:18:41] Speaker 00:
That's my understanding.

[00:18:43] Speaker 00:
That's where the court was to find on the queue in her favor.

[00:18:47] Speaker 00:
But again, the situation we find ourselves in now is putting ourselves in the board's shoes in 1980 with the laws it was.

[00:18:54] Speaker 02:
As of 1980 though, you don't point to any authority that says lack of documented informed consent.

[00:19:01] Speaker 02:
was not compensable negligence.

[00:19:04] Speaker 02:
Is that fair?

[00:19:04] Speaker 00:
That's fair.

[00:19:05] Speaker 00:
There's no such regulation that says, do not compensate if these are the situations.

[00:19:09] Speaker 02:
Can you point to any authority from our court, or really any authority that says, when we're in a situation like that, it cannot be undebatable?

[00:19:22] Speaker 02:
And I apologize for all the negatives.

[00:19:27] Speaker 02:
What compels us to say that it is undebatable

[00:19:31] Speaker 02:
given that there's really sort of an absence of authority at the time in 1980?

[00:19:34] Speaker 00:
Well, again, I was talking about a statutory authority.

[00:19:36] Speaker 00:
It's the regulatory authority that makes it undebatable.

[00:19:39] Speaker 00:
It is section 3.358C3, which says that compensation may not be payable for either the contemplative foreseeable after results of approved medical or surgical care properly administered, no matter how remote, in the absence of showing.

[00:19:54] Speaker 00:
And then it lists the things that must be shown to get that compensation.

[00:19:57] Speaker 00:
And it has to be

[00:19:58] Speaker 00:
carelessness, negligence, lack of proper skill, error in judgment, or similar instances of indicated fault.

[00:20:05] Speaker 00:
Now, this is not the argument Mrs Hatfield made, and the court can look to her brief before the VA, before the board, where the argument was solely the lack of documented informed consent is per se by itself reason for compensation.

[00:20:20] Speaker 00:
But the board was not looking at that.

[00:20:22] Speaker 00:
The board was looking at it.

[00:20:23] Speaker 00:
And again, this goes to why they sought, because I think it's important to point out, the 1980 decision is their second bite to the apple.

[00:20:29] Speaker 00:
They remanded it the first time in January 1980 to develop, they requested the entire medical record.

[00:20:35] Speaker 00:
They requested the independent medical advice so that they had every single piece of information they could have in front of them

[00:20:41] Speaker 00:
frankly, from what it appears, to try and find something.

[00:20:44] Speaker 00:
To try and find something that would allow them under 351 to provide extra compensation.

[00:20:48] Speaker 00:
They were very sympathetic to her case, and again, the language there, they speak to, they even acknowledge in that final sentence, and I will point again to appendix

[00:21:02] Speaker 00:
59 that they express acknowledged the duty to find in the appellate in the veterans and their parents Favor where possible to rule any issue of doubt in a favor of a sign the evidence leaves us with no doubt Care was done properly and that situation 351 ties our hands because we're only allowed to give this compensation There are other compensations.

[00:21:24] Speaker 00:
She may be entitled to survivor's benefits disability benefits and so on but this was a compensation and

[00:21:30] Speaker 00:
for his tragic death as a result of a reaction to medical treatment.

[00:21:35] Speaker 00:
The statute says Congress has told us and the regulation has restricted us to only giving in certain circumstances.

[00:21:45] Speaker 00:
and there's nothing here in 1980 that fits this language.

[00:21:48] Speaker 02:
They were not considering lack of informed consent in all of that analysis, correct?

[00:21:52] Speaker 00:
They were not considering it expressly, but they were considering the standard of care.

[00:21:55] Speaker 00:
They specifically asked these questions, was the veteran's care within the bounds of accepted medical practice?

[00:22:01] Speaker 00:
Now, the independent doctor

[00:22:04] Speaker 00:
did not come in and say the consent was obtained to its level because he said the care was done to acceptable practices, it was treated properly, it was fully appropriate treatment.

[00:22:14] Speaker 00:
I fully agree with the policy they took of not, and then it goes on to which treatments they did and did not do.

[00:22:20] Speaker 00:
And again, appendix 56, the chart indicates the therapy was indicated and was administered properly.

[00:22:29] Speaker 00:
If we're talking about lack of care, if we're talking about that sort of situation, what's the accepted medical practice?

[00:22:36] Speaker 00:
If there was an issue where consent has not been obtained where medical practice requires it, that would have been in that report, as we understand it.

[00:22:44] Speaker 00:
Or at least the board would have.

[00:22:45] Speaker 02:
I guess your view boils down to if it was truly undebatable in 1980 that you needed documented informed consent.

[00:23:00] Speaker 02:
absence of it means it's at least debatable.

[00:23:03] Speaker 00:
It's at least debatable, and it's definitely debatable.

[00:23:05] Speaker 00:
It's also something that wasn't directly being presented to the board as an issue.

[00:23:09] Speaker 00:
Mrs. Hatfield, her briefs are in the appendix or her letters to the board, and they speak to the damage the treatment has done, whether she questions whether it was the right treatment.

[00:23:18] Speaker 00:
But her letters speak of having discussions with the doctors about the treatment.

[00:23:23] Speaker 00:
She says, me and my husband will talk to about a radiologist.

[00:23:26] Speaker 00:
So to that degree,

[00:23:28] Speaker 00:
we'd have to, where would be the undebatable evidence that not only was there no informed consent, but on top of that, the informed consent was required by the statute, that there was an error that allowed compensation.

[00:23:44] Speaker 00:
It's a double level in that respect.

[00:23:47] Speaker 00:
And so on that front,

[00:23:50] Speaker 00:
Since counsel has spent spoken to the cycles case and how that brings in I don't know if the court needs us to address that But the remaining argument from this court is simply the is not the key arguments not whether Q applies in this case It is whether or not it was error for the court of veterans claims to not reverse the board

[00:24:11] Speaker 00:
for failing to agree with Appellant as to the implication of other statutes that concerned the development of medical practices but which did not teach to talk to compensation.

[00:24:21] Speaker 00:
I believe the key point there for the Court Member is if Congress is wielding the pen in the 1970s and is creating new statutes to say informed consent is important, if Congress wanted that to also apply to compensation, specifically compensation for complications from death, as they have done since,

[00:24:38] Speaker 00:
Congress had that power, and Congress chose not to do so.

[00:24:40] Speaker 00:
So to read that language in when it was specifically not included, we just don't see the grounds for doing so in this case.

[00:24:48] Speaker 00:
That's of course nothing further.

[00:24:49] Speaker 00:
I thank you for your time.

[00:24:51] Speaker 01:
Thank you, counsel.

[00:24:53] Speaker 01:
Mr. Locke has some more bottle time if you need to.

[00:25:05] Speaker 03:
Thank you, Your Honor.

[00:25:05] Speaker 03:
address a couple of questions that Judge Bryson asked to opposing counsel.

[00:25:10] Speaker 03:
1734 was in place.

[00:25:15] Speaker 03:
It came at the time of the veterans treatment, I should clarify.

[00:25:19] Speaker 03:
It came after the treatment, what was made effective in 1976, which evidences a strict liability view on VA's part to make it retroactive.

[00:25:30] Speaker 03:
Two, it does require that informed consent.

[00:25:32] Speaker 03:
In order to be informed consent,

[00:25:34] Speaker 03:
require that it be documented.

[00:25:36] Speaker 03:
Section 1734 outlines the standard for informed consent.

[00:25:40] Speaker 03:
It lists what must be disclosed, what must be documented, how that documentation must read.

[00:25:47] Speaker 03:
It has all these requirements in order for consent to be informed, to rise to the level of informed.

[00:25:53] Speaker 03:
So in response to the Secretary's argument that there is no undebatable error, there was a clear requirement to obtain informed consent

[00:26:01] Speaker 03:
In 1976, statutory and regulatory had requirements to fulfill that were not fulfilled.

[00:26:07] Speaker 04:
That was promulgated in 76, did you say?

[00:26:11] Speaker 03:
I believe it was promulgated in 78, made retroactive 76.

[00:26:15] Speaker 03:
OK.

[00:26:19] Speaker 03:
But regardless, the duty to obtain informed consent was first enacted under 4131 in 1976.

[00:26:29] Speaker 03:
The standard upon which to determine

[00:26:32] Speaker 03:
informed consent.

[00:26:32] Speaker 03:
That's what section 1734 addresses.

[00:26:36] Speaker 03:
I did also want to respond to the secretary's argument about 3.358C3 requiring negligence.

[00:26:45] Speaker 03:
Ms.

[00:26:45] Speaker 03:
Hatfield's argument all along has been that her care was not properly administered because it was performed without obtaining informed consent prior to the treatment.

[00:26:55] Speaker 03:
And when the secretary says that

[00:27:02] Speaker 03:
that the board relied on a medical opinion in 1980 that says the treatment rendered was proper.

[00:27:11] Speaker 03:
The only thing that that medical expert opined to was the dosage amount of the radiation that Mr. Hatfield received and said the dosage he received, the frequency he received it, the monitoring, the course of treatment, the follow-up care that was intended for chemotherapy, which he obviously never received, was a sound plan.

[00:27:31] Speaker 03:
and that, and further stated in appendix 69, that the fatal pneumonitis that Mr. Hatfield suffered from is a known risk of radiation.

[00:27:44] Speaker 03:
So if it's a known risk of radiation and there's no indication that it obtained his informed consent, that it disclosed you could die within seven weeks of this treatment, despite a statutory and regulatory requirement to do so,

[00:27:59] Speaker 03:
That is clear.

[00:28:00] Speaker 03:
They should have obtained that consent.

[00:28:02] Speaker 03:
That consent should have been documented by statute and regulation.

[00:28:09] Speaker 03:
There is certainly no evidence at the time of the board's decision that indicates Ms.

[00:28:15] Speaker 03:
Hatfield or the veteran was under the impression that death could have resulted from this treatment.

[00:28:22] Speaker 03:
We know this from appendix 65, 67, and 71.

[00:28:27] Speaker 03:
where Ms.

[00:28:29] Speaker 03:
Hatfield's statements are expressing complete confusion or puzzling about how the veteran could have died.

[00:28:36] Speaker 03:
Well, if she was told that you could die from this in seven weeks, there wouldn't be that confusion.

[00:28:41] Speaker 03:
They'd say this is a known risk.

[00:28:44] Speaker 03:
Obviously, it was a known risk as opined by the medical experts at the time of the 1984 decision.

[00:28:51] Speaker 01:
Counsel, your time has ended.

[00:28:54] Speaker 01:
Thank you for your argument.

[00:28:57] Speaker 01:
And the case is submitted.