[00:00:01] Speaker 04:
Face number 21-5083, John Gabriel Bernier versus Jeff Allen, Chief Physician at BOP Avalance.

[00:00:09] Speaker 04:
Mr. Himmelfarb for the Avalance, Mr. Howard for the Avalance.

[00:00:21] Speaker 00:
Okay, Council, Mr. Himmelfarb, you may proceed when you're ready.

[00:00:25] Speaker 03:
Thank you.

[00:00:26] Speaker 03:
May it please the court, Edward Himmelfarb of the Department of Justice, representing Dr. Jeff Allen, the Chief Medical Officer of the Bureau of Prisons.

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Jean-Gabriel Bernier is a former federal prisoner who was cured of hepatitis C while in prison in early 2017 with a direct acting antiviral drug called Zepatier.

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Almost five years later, Bernier is still pursuing this Bivens action because he had been turned down for a treatment a little over a year earlier.

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based on BOP's earlier protocol, which was designed to provide treatment with antiviral drugs to those prisoners in greatest need.

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The two new allegations in the second amended complaint that convinced the district court to deny qualified immunity to Dr. Allen are first,

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that the entire BOP protocol, treatment protocol, had no medical justification whatsoever and was totally based on the cost of the treatment.

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And second, that Dr. Allen was personally aware of some older blood test results for Bernier from his time in state prison.

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Now, both of those allegations, there are two problems with each of those allegations.

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The first problem, if you look at the protocol allegation, the first problem is that we're talking about the Bivens action.

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there is no allegation in the complaint, the Second Amendment complaint, that Dr. Allen was in any way responsible for this protocol.

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The protocol, if you look at paragraph 38 of the Second Amendment complaint, which is on page 115 of the Joint Appendix,

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What it says there is that BOP was responsible for this.

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It uses the term FBOP, Federal Bureau of Prisons, but that's what it's talking about, that the agency was responsible for this.

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So since Dr. Allen is not being alleged to have created this policy, he should not be sued.

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The second problem with the protocol allegation is, because we spent a lot of time in our brief talking about, that the idea is that it was somehow, the idea that it was,

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Based on cost alone and no medical justification makes no sense in the context of the exhibits that were attached to the complaint.

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Those exhibits are include not only the BOP protocol excerpts which show that it had medical justifications, but the the press release and the new protocol by the two medical organizations that the BOP whose original protocol, BOP's protocol was based on.

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So

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If the medical organizations protocol on which the BOP protocol was based, in fact, the complaint says that it was analogous to the medical organizations protocol.

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If the medical organizations protocol was based on medical justification, then it necessarily follows that the BOP protocol was based on a medical justification.

[00:03:17] Speaker 00:
I'm not so sure about that Mr Himmelfahr because there isn't any allegation or suggestion that the reason the Medical Association said to direct it to the sickest was

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to direct it to the people who would most benefit or to ration it because of any shortages of availability of the direct acting antiviral or because of shortages of staff.

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The reason, the only reason I see in the incorporated document is that the direct acting antiviral drug

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there were concerns about safety that had not been adequately dispelled.

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And in its 2015 announcement, the medical associations explained, we need to gain experience with their safety.

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We needed to gain experience with their safety before we encouraged all infected persons to initiate therapy.

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So it made sense, if you're worried about the safety of a drug,

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You might be willing to prescribe it to people who are really on the brink of death, and you might not be willing to prescribe it more broadly because its risks to the health of patients are greater than its potential

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benefit.

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And then what happened in, as I understand it, in 2015 is that the medical associations gained confidence that it wasn't risky and therefore should be made available to everyone else.

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So once that's been announced, it seems to take away the medical justification, which was that kind of cost benefit that shifted that

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completely.

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So continuing to rely on it, there might be other reasons, but the fact that the prior medical consensus tracked what BOP continued to do does not seem like support for your position.

[00:05:10] Speaker 03:
Your Honor, there are a couple of things in response to that.

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One is if you look at exhibit C, the press release accompanying the new protocol for the medical organizations in October 2015,

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It says, because of the cost of the new drugs or regional availability of appropriate health care providers, the practitioner may still need to decide which patients should be treated first.

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But that's a different point.

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That's a new and different argument from the one that they

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note above that they had relied on.

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And we don't have any information at the pleading stage whether the Bureau of Prisons was making decisions on either of those grounds.

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We don't know anything about the cost structure, whether BOP spends money and then reports that it needs that same amount or more the next year.

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We don't know anything about how hard this is to deploy.

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I mean, we're at the pleading stage here.

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So what Alan asserts and what the plaintiff claims is that the Bureau of Prisons just stuck with the old Medical Association's view after its own ground was abandoned.

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Well, Your Honor, just to respond to that quickly, the change came in October 2015.

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BOP gradually changed its protocol over the course of the next year.

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The application from Bernier came in in December 2015, in other words, two months after the change.

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The decision of the district court on the first amendment complaint made the perfectly reasonable point that DOP could not be expected to change on a dime.

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It would take a long time.

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In fact, if you look at Bernier's brief in this appeal, look at page 21 of their brief,

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They talk about how this qualified language in Exhibit C and D, about how this new protocol make time to implement in certain unique settings.

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They say that, let me see if I can get the exact language here.

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They say this was merely a recognition on the part of the panel.

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of the panel of the medical organizations, that implementation of the new protocol might not be instantaneous due to non-medical factors.

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And so if you think about what happened between October 2015 and December 2015, that's certainly a question of how long it takes to implement a new policy.

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And as I said, BOP implemented this new policy over the course of the following year and it ended up with a different policy.

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And under that new policy, Bernier was eligible for treatment of these antiviral drugs and he did get the treatment and he's been cured.

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The complaint says he's been cured.

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He had a pending request at that time, though, and we know that this is a very severe disease, indeed, can be life threatening.

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He also, and we haven't talked about the knowledge allegation directly yet, and I hope we will, but, you know, taking that in the light

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very favorable to the plaintiff would be that he had cirrhosis of the liver.

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And so one question is, even if it would take time for the protocol to change, why isn't it incumbent, why wasn't it incumbent on the medical personnel to prescribe these direct acting antivirals to someone presenting, at least with some evidence of cirrhosis?

[00:08:40] Speaker 03:
You're on there.

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If you look at the complaint, I'll give you the page number in a second.

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He was returned to federal custody in sometime in the early summer of 2015.

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So he was there for a few months.

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He was tested repeatedly.

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There's an allegation in here, his own complaint.

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I'm not quoting from somewhere else.

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He quotes the clinical director, FCI Allen, where they're saying that as of the examination date, which is August 2015,

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Bernier has not had any clinical symptoms of cirrhosis.

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So that was the evaluation a couple of months before his...

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application was submitted.

[00:09:22] Speaker 00:
If you take it, if you look at- Just on that point there, Mr. Himmelfarb, the complaint also at JA 109 110, paragraphs 15 and 16 includes, which Bernier not surprisingly cites in his brief, it was acknowledged by medical health providers at the facility that plaintiffs chronic noted health problems included hepatitis C and cirrhosis of the liver.

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and cirrhosis of the liver.

[00:09:54] Speaker 03:
Right.

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But I think what you need to look at, you're talking, remember, we're talking about Bivens actually against the chief medical officer of BOP, not against any of the personnel who examined them at Allenwood.

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None of those people are defendants in this Bivens case.

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And so the only thing that- He was the decision maker.

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They recommended, they sent the request up the chain.

[00:10:16] Speaker 03:
That's correct.

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Allen was the decision maker.

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That's correct.

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That's correct.

[00:10:20] Speaker 03:
But his decision was based on his exhibit A. There's a one page exhibit A. And if you go through this, it has a APRI test from December 15th.

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So it was about two weeks earlier than Dr. Allen said that he didn't qualify.

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The APRA was 0.40.

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The priority

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The priority requirement to get these treatment with these drugs at the time was 2.0.

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So that was a very, it was a recent, extremely recent test.

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It was very low.

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They also came with a liver biopsy report that was somewhat older, showed stage two fibrosis.

[00:11:03] Speaker 03:
There's a, they had a normal endoscopy the month before this request was put in.

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He appears to be, it says he appears to be priority level three

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current APRI of 0.402.

[00:11:16] Speaker 00:
The difficulty is for us, Mr. Hemel-Farber, I realize that there's other indicia in the record.

[00:11:23] Speaker 00:
The difficulty for us, we're certainly not medical personnel, but there is also in the record by the Bureau of Prison's own medical providers, a statement

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that plaintiff's health conditions included cirrhosis, and we also know from BOP's own policies that it doesn't look only at APRI, other indicia of cirrhosis are relevant, and we know the biopsies of a

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you know, a massive and formless organ like the liver that sometimes you don't get the tissue that's scarred.

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And so I guess just the question is not whether he wins on this record.

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The question is whether he's entitled to any to proceed at all with the claim for factual development.

[00:12:13] Speaker 03:
Your honor, I think your question leads into the issue of Dr. Allen's awareness of this because you're quoting something that he there's no evidence in the record whatsoever or any of no allegation the complaint whatsoever that he was aware of that.

[00:12:30] Speaker 00:
There is an allegation, and I understand that you take it to be, you characterize it as conclusory, but there is an allegation that Dr. Allen, as well as the clinical director Stahl, were aware of this.

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And that was something that the district judge was willing to accept.

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But go ahead.

[00:12:47] Speaker 03:
The bigger part, Your Honor.

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But what it says they were aware of was the fibroshoes scores from his time in state prison.

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Not any of these other things that we've been talking about.

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Only the fibroshoes scores.

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That's what the allegation is about.

[00:12:59] Speaker 00:
And the point I didn't see you arguing that the fiber sure scores didn't register a cirrhosis level of number we're arguing is that there are many different kinds of indicators.

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of tests for cirrhosis.

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And the medical, different medical providers use different tests.

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They're all, you know, they can argue about which one is better than which one, but APRI is a recognized indicator.

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They had a reading of this, not from 2011, 12, 14, whatever the state fibro-sure scores were, but from December 2015, just two weeks before the decision was made,

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about his priority.

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And so even if Dr. Allen had before him the state fibroscope scores, which is no evidence of, even if he had before him, it wouldn't make a difference.

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It's still a medical judgment how to balance two different indicators, two different tests

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But we don't have, I mean, I guess the question is what would permit us in light of evidence, so we have the knowledge question, we actually have to talk directly about that.

[00:14:10] Speaker 00:
But if Alan did know the statement that is in the medical record below, which is plaintiff's chronic health noted problems, including cirrhosis, if that were something that Alan saw, we don't know

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at the pleading stage.

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We can't just say, oh, there's other stuff to, you know, balance it out.

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You know, we have to hear how those things are balanced.

[00:14:38] Speaker 03:
I have to come back to the point that there's no allegation that he knew that there's an allegation.

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That's a separate issue.

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So we have to distinguish between the two.

[00:14:46] Speaker 00:
That's a separate issue.

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So the allegation

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that he knew the Fibersure scores.

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And are you contesting that if he knew the score that he would also read it to indicate cirrhosis?

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I didn't take that to be... He knows the score and if he credits it over other evidence, and I realize those are all matters not to be resolved, but if he knew the score, that would be a cirrhosis score.

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And the question is that he doesn't.

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Right, right.

[00:15:18] Speaker 03:
So non cirrhosis scores to and you as a medical professional, you need to balance the evidence before you.

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And you cannot say that a medical professionals balancing the evidence before him is violating the eighth amendment deliberately.

[00:15:30] Speaker 00:
We're not the medical professionals, but let me just ask the knowledge question.

[00:15:33] Speaker 00:
So it was acknowledged by the providers at the facility that his noted problems included cirrhosis and

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that they had, they acknowledged test results, three different test results earlier.

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We know this is a disease that doesn't tend to spontaneously resolve, it tends to progress and worsen over time.

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And we know that the Bureau of Prisons acknowledged that an APRI score is not necessary for diagnosing cirrhosis.

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It may be diagnosed by other means.

[00:16:03] Speaker 00:
And I hear you that you're saying just because there's one indicator and there are other tests that show to the contrary, maybe those other tests in medical judgment prevail.

[00:16:14] Speaker 00:
I hear you on that, but I'm just saying, we read the complaint and the light most favorable it's the plaintiff.

[00:16:19] Speaker 00:
So one indicium cirrhosis, and the, and yes we know that it wasn't included in the report that went up the chain that the.

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the reference to cirrhosis, but we also know that this is a plaintiff who acted with alacrity he tracked the change medical consensus, he requested this direct acting antiviral treatment, as soon as it was available he was a squeaky wheel.

[00:16:45] Speaker 00:
And just the fact that it wasn't on the paper does not exclude the possibility that there was discussion between the immediate care providers for this week you will, who rack up who sent this referred this request up the chain, and the ultimate decision maker we just aren't in a position to say that this stage are we.

[00:17:05] Speaker 03:
Yeah, I think you are, because if there were any such evidence of Dr. Allen's awareness of this, Bernier would have pleaded it.

[00:17:14] Speaker 03:
There is no pleading.

[00:17:16] Speaker 00:
I don't understand that, because in your own briefing, Mr. Himmelfarb, the blue brief, you say, Dr. Allen's subjective awareness is a matter that Bernier could not conceivably have personal knowledge of.

[00:17:27] Speaker 00:
I'm quoting your brief.

[00:17:28] Speaker 00:
And in the gray brief,

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Merely offering a conclusory allegation that Dr. Allen was subjectively aware of the FibroSher results, a matter that Bernier could not possibly know.

[00:17:37] Speaker 00:
I mean, this is a familiar problem, right, in the legal system when we need facts, and especially facts with some expertise brought to bear.

[00:17:48] Speaker 00:
we sometimes have to proceed to discovery, don't we?

[00:17:53] Speaker 03:
Not in this case, Your Honor, because what he could have done, we mentioned this in our brief too, what he could have done was he could have said that I spoke to the clinical director at Allenwood and he told me that he had had personal

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phone call with Dr. Allen in Washington, and that they discussed the fibroshoe scores.

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That would have been perfectly enough.

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We would not be here arguing that that was not good enough.

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The problem is when you make something up entirely like this, and again, let me say it's limited.

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The allegation that he was aware was limited to fibroshoe.

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It had nothing to do with any of the other test results or any of the other things that were done to Bernier during that several month period.

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has to do, it was limited to the fibrational results.

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If you have no basis for saying that he was subjectively aware of it, that's not good enough.

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Anyway.

[00:18:48] Speaker 00:
It's a reasonable inference from the treating people knowing it and writing it down and the patient asking for it early.

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And the people, I mean, often if people refer something up for,

[00:19:01] Speaker 00:
you know, with a recommended treatment and they get a no answer, they might well follow up and say, you know, hey, Alan, let's talk about this.

[00:19:10] Speaker 00:
You know, this guy has cirrhosis diagnosis that he's pushing on.

[00:19:16] Speaker 00:
What do we do about that?

[00:19:16] Speaker 00:
I mean, it's very possible.

[00:19:18] Speaker 03:
I think, Your Honor, I think if they had problems.

[00:19:21] Speaker 01:
Are we mixing up two issues here?

[00:19:24] Speaker 01:
Whether or not, Alan, your position is, Alan, there's nothing in the pleading

[00:19:31] Speaker 01:
Other than the inference that he looks at evidence generally to suggest that Alan knew about the Fibershore test, isn't that correct?

[00:19:43] Speaker 01:
Yes.

[00:19:43] Speaker 01:
Zero.

[00:19:44] Speaker 05:
Zero.

[00:19:47] Speaker 01:
And under ICPA, what's your analysis?

[00:19:53] Speaker 03:
Oh, this is that the allegation that he was aware, this is a conclusory allegation that there's no factual basis for it.

[00:20:02] Speaker 05:
And so it should not be considered assumed to be true.

[00:20:18] Speaker 07:
This goes back a little bit to whether there was any non-cost reason for the policy.

[00:20:31] Speaker 07:
Can you give us an example of someone outside of prison at the time, December 2015, that this decision was made, who would have been denied this treatment under the medical association's protocols?

[00:20:50] Speaker 02:
Under the old one or the new one?

[00:20:52] Speaker 07:
The new one.

[00:20:53] Speaker 07:
The revised one that was in effect in December 2015.

[00:20:56] Speaker 07:
someone outside of prison with Bernier's condition who would have been denied this treatment.

[00:21:02] Speaker 07:
I suspect there are people, I'm just wondering who they are.

[00:21:04] Speaker 03:
You skim through the exhibit D, it goes through a whole bunch of different categories of people, some of whom would not be given the drug here.

[00:21:20] Speaker 03:
That's why I talked about unique settings and I talked about

[00:21:24] Speaker 03:
continuing concern about availability and costs.

[00:21:28] Speaker 03:
So yes, there are some people, maybe, you know, the availability might be remote areas, rural areas of the country, there are people who are drug users who probably would be medically indicated not to get this drug.

[00:21:43] Speaker 03:
There's a section on HIV-infected men, incarcerated persons, persons on hemodialysis.

[00:21:50] Speaker 03:
So yes, the policy itself sets forth a bunch of different situations in which non-prisoners would not get this treatment either under the new policy.

[00:22:02] Speaker 01:
Counsel, may I ask you a question about the law cases?

[00:22:06] Speaker 01:
Is it fair for me to conclude there's a

[00:22:10] Speaker 01:
conflict between the third circuit and the 11th circuit on roughly similar cases?

[00:22:19] Speaker 03:
Well, are you talking about the Abu Jamal case?

[00:22:23] Speaker 01:
Yes, Jamal in the third circuit and Hoffer in the 11th circuit.

[00:22:33] Speaker 03:
The answer is that different courts have

[00:22:37] Speaker 03:
handle this a little bit differently.

[00:22:39] Speaker 01:
But yeah, I mean, I think offer makes the point that to make out a case of delivered indifference, it would have to be more than gross negligence.

[00:22:52] Speaker 03:
Well, that's what farmers said.

[00:22:53] Speaker 01:
I mean, and indeed, and Estelle versus Gamble, Justice Marshall made clear that malpractice would not be a case

[00:23:06] Speaker 01:
of delivered indifference.

[00:23:07] Speaker 03:
That's correct, Your Honor.

[00:23:09] Speaker 03:
And so, I think it was Farmer's case that said that the state of mind for a delivered indifference case is criminal recklessness.

[00:23:19] Speaker 03:
And so malpractice is definitely below that standard.

[00:23:23] Speaker 03:
It doesn't rise to that level.

[00:23:26] Speaker 03:
And so if there's evidence that a medical professional could reasonably balance,

[00:23:32] Speaker 03:
then even if he was aware of the FibroShirt scores, then he should have had qualified immunity here.

[00:23:39] Speaker 01:
Because in the Third Circuit, in the Jamal case, the language which the district court relied on is or prevents an inmate from receiving recommended treatment for serious medical needs.

[00:24:00] Speaker 01:
Do you disagree with that?

[00:24:02] Speaker 01:
That sounds pretty inconsistent with stealth versus gamble to me.

[00:24:14] Speaker 03:
He, I mean, I think you would still in that situation, you would still need to have the state of mind of criminal recklessness would not be enough to think of it as negligence.

[00:24:23] Speaker 03:
It had to be criminal recklessness to get to the eighth amendment violation.

[00:24:27] Speaker 03:
And so whether it's consistent or not, I think you have to read it to include the criminal recklessness subject of standard.

[00:24:35] Speaker 01:
Yes, that's why I'm inclined to think the 11th circuit view is quite different from the third circuit.

[00:24:42] Speaker 02:
Okay, yes.

[00:24:44] Speaker 02:
I'm certainly willing to accept that, yes, you're right.

[00:24:49] Speaker 00:
We talked about the protocol and that it was something like a year later that the Bureau changed its protocol after the medical associations came out with a new recommendation that virtually all patients should get and would benefit from direct acting antivirals.

[00:25:06] Speaker 00:
And one can imagine all kinds of reasons that might take the Bureau some time, but how do we at the pleading stage, help me out, how do we evaluate

[00:25:20] Speaker 00:
that delay.

[00:25:21] Speaker 00:
I understand your position on this plaintiff, but if you had a patient who was at the threshold of cirrhosis, wasn't under the old protocol eligible, but really would benefit and needs it to prevent permanent liver scarring, but the Bureau

[00:25:47] Speaker 00:
takes time.

[00:25:48] Speaker 00:
Like, how do we, how do we think about that at the pleading stage?

[00:25:52] Speaker 03:
Well, Your Honor, I just want to emphasize what you said at the beginning, which is that we're not talking about this case, because in this case, it was only two months after the change from the medical associations.

[00:26:02] Speaker 03:
And Bernier himself in his brief at page 21 admits that it was going to take some time to implement the new policy.

[00:26:09] Speaker 03:
So

[00:26:10] Speaker 03:
Going to your more specific question, BOP is a very large organization, I have to tell you.

[00:26:15] Speaker 03:
It's the entire federal prison system.

[00:26:18] Speaker 03:
And as of 2015, there were approximately 200,000 prisoners in many different institutions across the country.

[00:26:26] Speaker 03:
And so organizing medical treatment for the prisoners is always very difficult.

[00:26:31] Speaker 03:
And when it's a new treatment,

[00:26:33] Speaker 03:
It's especially difficult you're going to need things that you're going to have to make sure that your your your medical staff is properly trained you're going to have to.

[00:26:41] Speaker 03:
I mean, there are a whole bunch of considerations that go into it.

[00:26:44] Speaker 03:
And so it's more like a doctor's office.

[00:26:47] Speaker 00:
No, I understand.

[00:26:47] Speaker 00:
I'm just asking for help.

[00:26:49] Speaker 00:
How do we, because it seems to me a very factual issue.

[00:26:52] Speaker 00:
And if the Bureau were here with a couple of witnesses explaining how they take up new advice, how they expedite, how they deal with people who may be harmed during the bureaucratic process, that would be an easy case to credit

[00:27:10] Speaker 00:
Well, we don't have that.

[00:27:11] Speaker 00:
I'm asking you at the pleading stage, what are the tools?

[00:27:19] Speaker 00:
What's the best case for us to accept a delay that reading the complaint in the light most favorable to plaintiff could be a very damaging.

[00:27:32] Speaker 03:
Let me just go back to the point I've made before, because I think it fits in here to the response to your question.

[00:27:37] Speaker 03:
The question here is not the delay of a year.

[00:27:40] Speaker 03:
question here is a delay of two months because the only issue here has to do with the treatment of Bernier or the request for treatment for Bernier in December 2015, only two months after the change.

[00:27:54] Speaker 00:
That's not quite right.

[00:27:55] Speaker 00:
I thought your own position was that this was a

[00:28:00] Speaker 00:
a denial at the time, but that because they were continuing to monitor and manage every case, including Bernier's, that if after four months or six months or eight months, they were able to provide it, they would.

[00:28:15] Speaker 00:
So I'm pointing to the delay of a year because that's when they changed the protocol and actually give them treatment.

[00:28:22] Speaker 03:
That's right, Your Honor.

[00:28:23] Speaker 03:
But I don't see that as inconsistent with what I'm saying.

[00:28:26] Speaker 03:
The only issue here is

[00:28:28] Speaker 03:
was the denial in December 2015, a violation of the Eighth Amendment.

[00:28:34] Speaker 00:
And the continued denial until it was given.

[00:28:37] Speaker 03:
I think the issue is the denial in 2015.

[00:28:39] Speaker 00:
I thought Dr. Allen's position was we were appropriately monitoring him.

[00:28:49] Speaker 03:
Well, that's correct.

[00:28:50] Speaker 03:
But the legal issue here is what happened in December 2015.

[00:28:55] Speaker 00:
I'm not sure this is actually responsive to the question.

[00:28:59] Speaker 00:
Are there cases?

[00:29:01] Speaker 00:
Is there a doctrinal way to help us think about and excuse a year's delay on the government's part, assuming there will be some patience during that year

[00:29:18] Speaker 00:
who had the Medical Association's protocol been more quickly implemented would have avoided serious and permanent harm to their health or even death.

[00:29:32] Speaker 03:
Your Honor, I think if you look at the August 2019 opinion of the District Court when it granted qualified immunity on the first amended complaint, there's a discussion in there about the change, the rapidly evolving

[00:29:46] Speaker 03:
change in the medical understanding of this disease.

[00:29:50] Speaker 00:
I understand there's a common sense way to reason it through.

[00:29:52] Speaker 00:
I'm asking for legal and doctrinal authority that gives us a way to make this point.

[00:30:01] Speaker 00:
What's the legal framework for us to excuse government?

[00:30:07] Speaker 00:
I understand there must be in every case.

[00:30:10] Speaker 00:
This is a complicated bureaucracy, as you said, and I think I'm trying to actually ask

[00:30:15] Speaker 03:
The doctrinal rubric is clearly established.

[00:30:20] Speaker 03:
There's no clearly established violation of the Eighth Amendment in this case.

[00:30:24] Speaker 03:
And that's the rubric.

[00:30:26] Speaker 03:
That's the doctrine.

[00:30:27] Speaker 01:
Council, may I ask about the monitoring?

[00:30:33] Speaker 01:
What did the monitoring consist of?

[00:30:36] Speaker 03:
Well, prisoners are often, especially ones with recognized diseases, are certainly able to go and have tests done at their institution.

[00:30:48] Speaker 03:
So it's that kind of monitoring to see whether the condition is changing for the worse, to see whether their priority would change.

[00:30:58] Speaker 01:
Was there any indication that his situation was changing for the worse?

[00:31:03] Speaker 01:
He was in category three, right?

[00:31:05] Speaker 02:
That's correct.

[00:31:07] Speaker 01:
And how was category three designated?

[00:31:11] Speaker 02:
What were the rules for category three?

[00:31:13] Speaker 01:
Yeah, what's the description?

[00:31:16] Speaker 03:
Well, I think it's best if I read you from and tell you what the page number is and refer you to that page.

[00:31:25] Speaker 03:
Category three is on joint appendix page 128.

[00:31:29] Speaker 03:
What it says is intermediate priority for treatment, stage two fibrosis on liver biopsy,

[00:31:37] Speaker 03:
APRI score of 1.5 to less than two, diabetes mellitus, and porphyria cutanea tardia, which I admit I don't understand, but there are various medical indicia that would put an individual in prison in this category three.

[00:31:57] Speaker 01:
Was there ever an indication that he went up to category two or one?

[00:32:05] Speaker 03:
Under the old protocol, no.

[00:32:08] Speaker 03:
What happened is that BOP changed the protocol and it allowed treatment of people who were not- No, I understand that.

[00:32:17] Speaker 01:
But was there ever a change in his status from before the new protocol came into effect?

[00:32:23] Speaker 03:
No.

[00:32:25] Speaker 05:
And certainly not alleged in complaint, no.

[00:32:31] Speaker 04:
Are there questions, Judge Walker?

[00:32:35] Speaker 00:
Mr. Silverman?

[00:32:36] Speaker 01:
No other questions.

[00:32:38] Speaker 00:
All right, thank you very much, Mr. Hemelkar.

[00:32:40] Speaker 00:
We took you largely with my questions way over your time, but we will give you some rebuttal time after we've heard from Mr. Howard.

[00:32:49] Speaker 00:
Thank you, Your Honor.

[00:32:51] Speaker 00:
Thank you.

[00:32:51] Speaker 00:
Mr. Howard, you may proceed when you're ready.

[00:32:53] Speaker 08:
Thank you, Your Honor, and may it please the court, Theodore Howard for the appellee, Sean Gabriel Bernier.

[00:33:01] Speaker 08:
Given the nature of the questioning of Mr. Himmelfarb, Your Honor, although I had intended to focus initially on the alternative ground that we believe would suffice to affirm the district court's decision to deny the motion, namely that Estelle versus Gamble in itself is sufficient to establish the clearly established right at issue here,

[00:33:29] Speaker 08:
I'll try to focus some of my time on the second issue, which is the sufficiency of Mr. Bernier's allegations at the pleading stage with respect to a cost basis for the determination by Dr. Allen to deny him treatment in reliance on the then existing BLP protocol.

[00:33:56] Speaker 08:
And secondly,

[00:33:59] Speaker 08:
Dr. Allen's knowledge with regard to alternative information to the APRI test results sufficient to alert him to the fact that Mr. Bernier needed treatment and that such treatment was denied.

[00:34:18] Speaker 01:
Do I take your position to be that the initial protocol was itself

[00:34:26] Speaker 01:
indication of deliberate indifference?

[00:34:34] Speaker 08:
No, Your Honor, I can't say that because although it seems apparent that the BOP protocol that was in effect as of December 2015, upon which Dr. Allen relied,

[00:34:52] Speaker 08:
was a bureaucratic administrative protocol basically designed to ration treatment to those most in need while... I read your argument as indicating that the initial protocol itself was an indication of deliberate indifference.

[00:35:21] Speaker 01:
Well, your honor, I think it came deliberately and different once once the Medical Associations had had made their new I was wondering, I was really asking whether your position was the initial.

[00:35:35] Speaker 08:
I understand your question, Your Honor, and I understand the basis for it.

[00:35:41] Speaker 08:
The basis would be for making that contention would be that in designing a protocol that was premised upon the idea of rationing treatment and only providing it to those in most serious need,

[00:36:01] Speaker 08:
under circumstances in which this disease, hepatitis C, is a progressive disease that once it starts doesn't really stop until it's been treated, that the BOP was in effect making a conscious decision that a certain number of people with a progressive disease were not going to be treated until they reached a certain level of severity.

[00:36:27] Speaker 01:
Yes, so I understood your position.

[00:36:30] Speaker 01:
It is as I stated, you believe that the initial protocol itself was an indication of a deliberate indifference because it relied on cost factors.

[00:36:42] Speaker 08:
I think it could certainly be characterized as such, Your Honor.

[00:36:45] Speaker 01:
Well, that is not characterized.

[00:36:48] Speaker 08:
Well, that is the way that we've described it.

[00:36:50] Speaker 08:
But that is not the premise for our position.

[00:36:53] Speaker 08:
Our position is that irrespective of whether or not the protocol was constitutionally flawed prior to the change in the standard of care,

[00:37:07] Speaker 08:
certainly after the standard of care was altered such that the authoritative medical authorities.

[00:37:20] Speaker 01:
Even in the medical authorities acknowledge there were the difficulties in the prison setting.

[00:37:29] Speaker 08:
I think that's just a statement of fact.

[00:37:34] Speaker 08:
your honor, in the policy statement.

[00:37:37] Speaker 01:
It goes to the protocol, doesn't it?

[00:37:42] Speaker 08:
Well, your honor, I think that the medical panels were merely recognizing that in an ideal world, these drugs would be implemented immediately, and everyone who has hepatitis C would receive them.

[00:37:57] Speaker 08:
And the fact is that that probably can't happen.

[00:38:01] Speaker 08:
And it probably can happen in a variety of circumstances, including but not limited to the fact that prisons may have constraints on their ability to implement immediately.

[00:38:14] Speaker 00:
Where do you see that?

[00:38:15] Speaker 00:
Actually, the one place in the new medical protocol where incarcerated persons or prisons are directly discussed is the JA 142, where it talks about

[00:38:30] Speaker 00:
coordinated treatment efforts within prison systems would likely rapidly decrease the prevalence of HCV infection in this at risk population.

[00:38:37] Speaker 00:
And there's nothing there specific to

[00:38:43] Speaker 00:
either, you know, bureaucratic delays or shortage of staff or even cost reference specifically with requests to prison.

[00:38:54] Speaker 00:
So I actually don't see that.

[00:38:56] Speaker 00:
I mean, I do see which Mr. Himmelfarb's brief quotes that on the sort of cover press release or whatever it is, the first page, JA 130,

[00:39:09] Speaker 00:
that the medical associations acknowledge that because of the cost of the new drugs or regional availability of appropriate health care providers, a practitioner may still need to decide which person's, that's a very general statement, not at all keyed to prison.

[00:39:26] Speaker 00:
So when you talk about some acknowledgement of bureaucratic challenges in prisons, which aspect of the medical protocol are you referring to?

[00:39:35] Speaker 08:
I'm not your honor.

[00:39:36] Speaker 08:
It's our position that as of October of 2015, the prioritization protocols that had previously existed or been endorsed by the medical panels on the grounds that

[00:39:52] Speaker 08:
reliance, pure reliance on clinical trials was inadequate to give the blessing to the widespread implementation of this new course of treatment.

[00:40:08] Speaker 08:
It's our position that that was an unequivocal change in the standard of care.

[00:40:13] Speaker 08:
The fact that the panels recognize that there might be some instances in which

[00:40:20] Speaker 08:
implementation of the new standard of care might be, there might be impediments, was not at all stepping back from their determination.

[00:40:30] Speaker 00:
This is the course of treatment for people with hepatitis C. How quickly does the Bureau of Prisons need to integrate a new medical consensus into its protocols for its, in your view, for its action to avoid deliberate indifference?

[00:40:46] Speaker 00:
And what case can you point us to that's most supportive of your position?

[00:40:51] Speaker 08:
Your Honor, the case law that has emerged since the direct acting antiviral medications came to the fore.

[00:41:03] Speaker 08:
has been quite variable with regard to the views of courts in terms of how quickly implementation should have taken place.

[00:41:12] Speaker 08:
So I do not have a definitive answer for you with regard to.

[00:41:17] Speaker 00:
But you're arguing, you're asking us to make a decision.

[00:41:19] Speaker 00:
How quickly do you believe, are you urging us to hold that BOP needs to act in integrating a new medical consensus?

[00:41:28] Speaker 00:
And what's your best case?

[00:41:30] Speaker 08:
Your Honor, I think that the

[00:41:34] Speaker 08:
Well, certainly our position is that by the end of December of 2015, Dr. Allen, who in his declarations asserts his own knowledge and expertise with regard to hepatitis C treatment, that if in fact, as we allege, he had sufficient evidence to know that Mr. Bernier

[00:42:03] Speaker 08:
had cirrhosis, notwithstanding the apri tests, then certainly it's our view that he should have acted in accordance with the new medical standard of care and provided Mr. Bernier with treatment.

[00:42:20] Speaker 01:
Is the key to your case that you think he was mischaracterized as in level three?

[00:42:28] Speaker 08:
No, Your Honor.

[00:42:29] Speaker 01:
The key to what?

[00:42:30] Speaker 01:
The level three characterization was

[00:42:33] Speaker 01:
was appropriate.

[00:42:35] Speaker 08:
By the measures by which they make those determinations, we have no evidence that that was an inaccurate classification, Your Honor.

[00:42:46] Speaker 01:
You're not making any allegation to that effect.

[00:42:49] Speaker 08:
I'm not, Your Honor.

[00:42:50] Speaker 08:
Our position is that once the standard of care change.

[00:42:55] Speaker 01:
Excuse me.

[00:42:55] Speaker 01:
Let me just pursue.

[00:42:57] Speaker 01:
In category three, if I may speak roughly,

[00:43:02] Speaker 01:
a person in category three was not in danger of life threatening situation, right?

[00:43:10] Speaker 08:
They certainly under the classification measures that were used to place Mr. Bernier in category three, he was not regarded as an immediate danger of the most severe consequences of hepatitis C. So you're not arguing that the existence of the fiber shore test results

[00:43:32] Speaker 00:
alone meant that Mr. Bernier actually had cirrhosis.

[00:43:36] Speaker 00:
That's not your argument.

[00:43:37] Speaker 00:
Your argument is a more nuanced argument about the protocol and how quickly there's uptake of the new standard of care.

[00:43:45] Speaker 08:
Your honor, I think that's right.

[00:43:47] Speaker 08:
I mean, essentially, after the standard of care changed, the continuing reliance on this classification

[00:44:01] Speaker 08:
and who gets medication when was deprived of its foundation.

[00:44:08] Speaker 08:
And so, I'm sorry, go ahead.

[00:44:12] Speaker 07:
Why shouldn't we say this?

[00:44:16] Speaker 07:
Your case depends on, according to what you just said, the argument that BOP is continuing reliance on its previous system.

[00:44:28] Speaker 07:
uh, was an eighth amendment violation.

[00:44:31] Speaker 07:
And you said a few moments ago that courts have been quite variable on that very question, which seems to suggest that even if there was an eighth amendment violation here, it wasn't a clearly established eighth amendment violation.

[00:44:47] Speaker 07:
And that, that maybe is enough for us to just say that and move along.

[00:44:54] Speaker 08:
Your honor our position with respect to that is that there was from Estelle versus gamble on a continuum of decisions by the courts the federal courts with regard to eighth amendment claims,

[00:45:13] Speaker 08:
hepatitis C cases prior to the advent of the emergence of direct acting antiviral medications.

[00:45:23] Speaker 01:
Forgive me for that.

[00:45:25] Speaker 01:
Forgive me for interrupting you.

[00:45:27] Speaker 01:
But in Estelle versus Campbell, Justice Marshall's opinion went out of his way to make clear that malpractice would not be adequate to show an Eighth Amendment violation.

[00:45:43] Speaker 09:
That's correct, Your Honor.

[00:45:44] Speaker 01:
And in the 11th Circuit, even gross negligence would not be adequate to allege an Eighth Amendment violation.

[00:45:59] Speaker 09:
Apparently, Your Honor, on the basis of the case you made reference to during Mr. Himmelfarb's argument.

[00:46:06] Speaker 01:
Well, that follows up on my colleague's point.

[00:46:11] Speaker 01:
How can it be argued then

[00:46:14] Speaker 01:
that there was a clearly established right here, constitutional right, to get the latest, best, best, best treatment.

[00:46:26] Speaker 08:
And Your Honor, my answer to that is that as cited in our papers, there are cases that preceded the advent of this new medical treatment

[00:46:41] Speaker 08:
addressing claims by prisoners of denial of care for hepatitis C on the basis of bureaucratic administrative protocols, similar in nature to the BOP protocol that was in effect in December of 2015, where courts held that your reliance on this protocol

[00:47:09] Speaker 08:
in ignorance of the particular circumstances of this prisoner constitutes deliberate indifference.

[00:47:18] Speaker 01:
Suppose I was a private citizen and went to a doctor with the concern that I had cirrhosis of the liver and the doctor in December of 2015 or let's say February of 2016 said, you know, I'm a little worried about this new

[00:47:39] Speaker 01:
treatment and i'm going to delay it for a while maybe for four or five months if you don't get any worse before i prescribe it what would you think you think that's a case of negligence i would say it would be under the

[00:48:05] Speaker 08:
standard of care that had been established by the medical panels as of October 2015.

[00:48:10] Speaker 01:
So you think you make out a case of negligence?

[00:48:15] Speaker 08:
I think under those circumstances, a case for medical malpractice in the nature of negligence could be made out.

[00:48:21] Speaker 08:
Yes, Your Honor.

[00:48:23] Speaker 00:
Mr. Howard, you made an allegation that the Bureau of Prisons does not in actual practice perform or accept

[00:48:33] Speaker 00:
What's the basis and the import of that allegation in your case?

[00:48:39] Speaker 00:
It wasn't entirely clear to me whether that helps you, and if so, why?

[00:48:45] Speaker 00:
That the Bureau doesn't, in actual practice, perform or accept fibro-sure.

[00:48:52] Speaker 08:
Your Honor, the premise is that notwithstanding their own written policy,

[00:49:04] Speaker 08:
that the APRI score is not the be-all and end-all if there are other indicia of cirrhosis.

[00:49:17] Speaker 08:
And the fact that in this instance, we contend that Dr. Allen knew of fibrous sure results, but ignored them.

[00:49:26] Speaker 08:
is an indication that they not withstanding their own policy saying that other types of evidence can be accepted, they don't actually look beyond Opry.

[00:49:38] Speaker 01:
What is your allegation?

[00:49:41] Speaker 01:
What is the allegation that Dr. Allen knew about the fiber sure test?

[00:49:50] Speaker 08:
That is what it is, Your Honor.

[00:49:52] Speaker 08:
We have alleged that we, our belief, Mr. Bernier's belief that Dr. Allen knew of his Fibersure results.

[00:50:01] Speaker 01:
Well, what do you have, other than I bear a conclusion, what do you have to support that?

[00:50:07] Speaker 08:
At the pleading stage, we don't have anything, Your Honor.

[00:50:10] Speaker 01:
Well, how do you get by it then?

[00:50:13] Speaker 08:
Well, Your Honor, I think we get by Iqbal on the same basis as the plaintiff slash petitioner in Erickson versus Pardus, as decided by the Supreme Court, got by Bell Atlantic, which was the predecessor of Iqbal and basically articulates the same standard.

[00:50:33] Speaker 01:
That was a pro se case.

[00:50:36] Speaker 08:
It was a pro se case, but that was not the premise upon which the Supreme Court reversed summarily a decision that a magistrate judge, a district judge, and the 10th Circuit had all held that the plaintiff's allegations were inadequate.

[00:50:57] Speaker 08:
The Supreme Court said, no, they're not inadequate because under Rule 8A2,

[00:51:02] Speaker 08:
He said he's made clear allegations that are sufficient to put the defendant on notice as to what he's claiming.

[00:51:12] Speaker 07:
Mr. Howard, what are we supposed to do with a decision from a U.S.

[00:51:18] Speaker 07:
District Court in New York that adopted a magistrate judge's report in a suit Mr. Bernier brought against the state

[00:51:28] Speaker 07:
medical doctors who were responsible for his care up until August of 2015.

[00:51:35] Speaker 07:
And what the decision says is, and this was on summary judgment, so this was not at the pleading stages, it says that Mr. Bernier failed to show as of August of 2015.

[00:51:48] Speaker 07:
that his condition was such that he faced a substantial risk of serious harm if untreated, much less that his infection was causing him to experience any serious symptoms or ill effects.

[00:51:59] Speaker 07:
Now, I recognize that four months passed between August 2015 and December 2015 when Dr. Allen made his decision here, but

[00:52:12] Speaker 07:
Do you think that we're allowed to consider what was found in that US District Court case in New York and not only consider what would you say to the possibility that it has some kind of a preclusive effect?

[00:52:27] Speaker 08:
I'm Judge Walker I have to confess that I am not familiar with the district court decision to which you make reference.

[00:52:35] Speaker 08:
And I guess neither apparently was Mr him far.

[00:52:41] Speaker 08:
Oh, because I'm confident that he is quite capable and would have cited it to us.

[00:52:50] Speaker 07:
I didn't find it myself either.

[00:52:52] Speaker 07:
I have to confess my my crack lock.

[00:52:55] Speaker 07:
My crack lock.

[00:52:56] Speaker 00:
I thought that was cited anywhere.

[00:52:59] Speaker 08:
Without more knowledge as to the specifics, I couldn't really say whether it is race truticata or collateral estoppel, but if it went to the question specifically of hepatitis C, I guess that my premise would be that

[00:53:23] Speaker 08:
that decision was based on a set, a state of, I'm sorry, a body of evidence available to that court at that time with respect to a progressive disease.

[00:53:37] Speaker 08:
And so it wouldn't necessarily preclude Mr. Bernier from having initiated this case on the basis of the BOP's decision.

[00:53:57] Speaker 08:
So I guess I would just say in conclusion that the qualified immunity defense asserted by Dr. Allen has not been rejected.

[00:54:15] Speaker 08:
The district court has held that there are allegations in the complaint worthy of recognition.

[00:54:22] Speaker 08:
Dr. Allen disputes

[00:54:26] Speaker 08:
those allegations.

[00:54:31] Speaker 08:
The case should proceed to allow for some exploration with regard to the validity of Dr. Allen's denials.

[00:54:42] Speaker 08:
The district court is clearly in a position to exercise its discretion to regulate the conduct of discovery in a way that minimizes inconvenience or consumption or consumption of time on the part of Dr Alan.

[00:54:59] Speaker 08:
until we get to the point where Mr. Bernier has either established a basis to depose Dr. Allen or the documents that have been acquired through discovery fail to validate Mr. Bernier's allegations, in which case we probably don't even get that far.

[00:55:24] Speaker 08:
However,

[00:55:27] Speaker 08:
the allegations were certainly equivalent to those regarded as sufficient in Erickson, in Abu Jamal, in the decision of the Third Circuit.

[00:55:41] Speaker 08:
And this court, in the case of Nawab Safavi versus Glassman, 637 F3, 311,

[00:55:56] Speaker 08:
A case which we cited in some of our papers in the district court and certainly should have cited in our brief on appeal.

[00:56:05] Speaker 08:
This court has certainly recognized that qualified immunity defenses sometimes have to wait.

[00:56:15] Speaker 08:
adjudication until there has been a development of disputed facts, a record with regard to disputed facts sufficient to allow the court to determine whether or not the knowledge of the defendant

[00:56:33] Speaker 08:
indicates that a clearly established right was or was not violated.

[00:56:38] Speaker 08:
And we believe that's the case here.

[00:56:39] Speaker 08:
And on that basis, we would request that the district court's decision to deny the motion to dismiss be affirmed.

[00:56:47] Speaker 08:
Thank you.

[00:56:49] Speaker 00:
Thank you, Mr. Howard.

[00:56:50] Speaker 00:
Now, Mr. Himmelfarb, we've offered you some time for rebuttal.

[00:56:57] Speaker 03:
Okay, I have a couple of quick points as the court can stand it.

[00:57:02] Speaker 03:
First point is that Mr. Howard was talking about how the new protocol for the medical organizations was a change in the standard of care and that Dr. Allen should have followed it.

[00:57:14] Speaker 03:
That's not the Eighth Amendment standard.

[00:57:15] Speaker 03:
Eighth Amendment standard is deliberate indifference.

[00:57:17] Speaker 03:
That's a malpractice standard.

[00:57:18] Speaker 03:
I think Judge Silverman may have been getting at that point, but that's a malpractice standard, not a deliberate indifference standard.

[00:57:25] Speaker 03:
Second point is Mr. Howard mentioned

[00:57:27] Speaker 03:
variable court decisions.

[00:57:29] Speaker 01:
What do you mean I may have been getting at that?

[00:57:33] Speaker 03:
I wouldn't want to presume, Your Honor.

[00:57:39] Speaker 03:
Mr. Howard talked about variable court decisions.

[00:57:42] Speaker 03:
Well, that by definition means that it's not clearly established.

[00:57:45] Speaker 03:
You need more than variable court decisions.

[00:57:51] Speaker 03:
This case, remember, just to get back to this basic point, this case is a Bivens action against Dr. Allen.

[00:57:57] Speaker 03:
There's no allegation Dr. Allen was responsible for this policy.

[00:58:02] Speaker 03:
If Bernier wanted to deal with the policy, he could have brought an injunction suit.

[00:58:06] Speaker 03:
In fact, he did that originally.

[00:58:08] Speaker 03:
And this court, I believe in its decision on appeal from the denial of preliminary injunctive relief, said that it was moot because he got the relief.

[00:58:18] Speaker 03:
He was given the treatment.

[00:58:22] Speaker 03:
And last, I don't know, maybe getting to the little bit trivial points here, but the Erickson case in the Supreme Court,

[00:58:27] Speaker 03:
there were a lot more allegations going on in that case than there are here.

[00:58:31] Speaker 03:
There were allegations about a syringe that there was a different treatment, that there's some syringe use, that the prison officials blamed the plaintiff for altering the syringe to use for drug injection.

[00:58:47] Speaker 03:
So there were a lot more factual allegations.

[00:58:49] Speaker 03:
It wasn't just that it was a pro se plaintiff, which it was, and that's relevant.

[00:58:53] Speaker 03:
but it was also a bunch of more specific allegations.

[00:58:57] Speaker 03:
So unless the court has further questions, we would ask the court to reverse here, to vacate and to qualify the immunity granted.

[00:59:10] Speaker 00:
Thank you, Mr. Hemmelfarb.

[00:59:11] Speaker 00:
Thank you, Mr. Howard, for your pro bono service.

[00:59:13] Speaker 00:
The case is submitted.