Jean-Gabriel Bernier v. Jeff Allen

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued January 25, 2022 Decided July 5, 2022

No. 21-5083

JEAN-GABRIEL BERNIER,

APPELLEE

v.

JEFF ALLEN, CHIEF PHYSICIAN, FBOP,

APPELLANT

Appeal from the United States District Court

for the District of Columbia

(No. 1:16-cv-00828)

Edward Himmelfarb, Attorney, U.S. Department of

Justice, argued the cause for appellant. With him on the briefs

were Brian M. Boynton, Acting Assistant Attorney General,

and Barbara L. Herwig, Attorney.

Theodore A. Howard argued the cause and filed the brief

for appellee.

Before: PILLARD and WALKER, Circuit Judges, and

SILBERMAN, Senior Circuit Judge.

Opinion for the Court filed by Circuit Judge PILLARD.

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Opinion concurring in the judgment filed by Senior Circuit

Judge Silberman.

PILLARD, Circuit Judge: The Federal Bureau of Prisons

cured inmate Jean-Gabriel Bernier’s chronic Hepatitis C with

pathbreaking and costly drugs. Bernier contends that he should

have been treated earlier, within weeks of a new medical

consensus recommending the drug even for patients like him in

stable and non-life-threatening stages of the disease. He sues

Dr. Jeffery Allen, the BOP Medical Director, for damages to

compensate for the cruel and unusual punishment Bernier

contends Allen inflicted by failing to grant his initial treatment

request. Because under the circumstances as alleged Dr.

Allen’s decision violated no clearly established Eighth

Amendment right, we hold that the doctor is entitled to

qualified immunity from Bernier’s damages claim.

INTRODUCTION

While he was incarcerated in federal prison and suffering

from Hepatitis C, Bernier applied in December 2015 to receive

treatment with Harvoni, a relatively new direct-acting antiviral

drug he alleges “produced amazing results with cure rates

nearing 100%” in patients like him. Second Amended

Complaint (Complaint) ¶ 14. According to experts Bernier

cites, “[a]mong incarcerated individuals, the rate of HCV

seroprevalence ranges from 30% to 60%.” J.A. 142

(Complaint Exhibit D). Under the treatment protocol then in

place at the Federal Bureau of Prisons (BOP or Bureau),

however, only Hepatitis C patients with certain indicia of

advanced-stage liver disease were deemed “high priority” or

“highest priority” and treated with Harvoni. BOP adopted that

protocol when the medical consensus favored waiting to “gain

experience with the []safety” of the new direct-acting antivirals

before approving their broader use for less symptomatic

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patients. Complaint ¶ 43. Because Bernier lacked the indicia

of advanced-stage liver disease, Dr. Allen denied Bernier’s

application for treatment with Harvoni.

Bernier did not dispute that as of December 2015 his

illness was not at a stage that entitled him to receive Harvoni

under BOP’s then-operative protocol. But he pointed to the

fact that a panel of medical experts had just announced in

October 2015 that clinical experience had sufficiently

established the safety of Harvoni to justify its broader use.

Indeed, in light of the report that Harvoni should be used to

treat most Hepatitis C patients, including those like Bernier

who were not among the most seriously ill, the BOP updated

its protocol while this suit was pending to broaden access to

direct-acting antiviral drugs. Pursuant to the revised protocol,

the Bureau eventually approved a renewed request on Bernier’s

behalf. Bernier received treatment and his Hepatitis C has

since been cured. Complaint ¶ 25.

His sole remaining claim seeks damages under Bivens v.

Six Unknown Named Agents of Fed. Bureau of Narcotics, 403

U.S. 388 (1971), from Dr. Allen. He claims that Dr. Allen’s

initial refusal to approve Harvoni treatment for him in

December of 2015 was “a conscious decision to ration the

recommended treatment,” made solely “to minimize the high

cost attending the administration of drugs such as Harvoni, not

on the basis of any medical justification.” Complaint ¶ 22.

The validity or not of the revised BOP treatment protocol for

Hepatitis C is not in issue, nor does Bernier make any claim

that the Bureau moved too slowly in amending its Hepatitis C

treatment protocol in response to the shifting medical

consensus. Rather, Bernier contends that, in view of the state

of his health at the time and the October shift in the announced

medical consensus in favor of broader use of direct-acting

antiviral drugs, Dr. Allen’s failure two months later to make an

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exception from the not-yet-amended protocol to treat Bernier

with Harvoni was clearly unconstitutional. In particular,

Bernier asserts that his allegation of the high cost of Harvoni

suffices to plausibly plead that budgetary concerns displaced

medical judgment in Dr. Allen’s December 2015 decision.

And he argues that, as a legal matter, it is clearly established

that a decision based on non-medical reasons like cost to deny

treatment for a serious medical need constitutes deliberate

indifference in violation of the Eighth Amendment. Complaint

¶¶ 27-49.

The district court denied Dr. Allen’s motion to dismiss or

for summary judgment based on qualified immunity, and Allen

is before us on interlocutory review. We conclude that Bernier

fails to state a claim of violation of any Eighth Amendment

right that was clearly established at the relevant time. He relies

on what he describes as a consensus of authority that prison

officials’ denial of treatment for a serious medical condition for

no reason other than cost violates inmates’ clearly established

Eighth Amendment rights. The complaint does not plausibly

plead that Dr. Allen’s December 2015 denial of Harvoni for

Bernier’s Hepatitis C was solely to save money in reckless

disregard of any medical consequences. Nor do any of the

precedents on which he relies otherwise recognize an Eighth

Amendment violation in circumstances materially similar to

his. We accordingly reverse the district court’s denial of

qualified immunity.

BACKGROUND

A. Factual allegations

Because this appeal arises at the motion to dismiss stage,

the relevant facts are drawn from the well-pleaded allegations

of Bernier’s Second Amended Complaint, with all reasonable

factual inferences drawn in his favor. Bernier, a Black man

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who was sixty-one years old at the time of his complaint, began

his incarceration in June 1990 under the custody of the State of

New York Department of Corrections. He was transferred in

August 2015 to the Federal Correctional Institution in

Allenwood, Pennsylvania (FCI-Allenwood), where he was

subjected to the treatment decisions at issue here.

Bernier was first diagnosed with Hepatitis C in state prison

in 1999. Hepatitis C is a virus that resides in liver cells and

causes progressive liver damage. The disease is typically

chronic, and in advanced stages often results in cirrhosis, an

inflammation and scarring of liver tissue. As it progresses,

Hepatitis C impairs and can even destroy the organ’s function.

If left untreated, cirrhosis can be fatal.

The complaint identifies several techniques for diagnosing

the progression of Hepatitis C and the risk and presence of

cirrhosis. Liver biopsies, for example, surgically remove and

examine a small piece of liver tissue for damage, with the

potential disadvantage that the piece is not a representative

sample of the liver’s condition. A less invasive alternative is

an ultrasound scan, which may be able to detect abnormalities

in the liver’s structure. Other diagnostic techniques take

measurements from blood samples. Measuring liver enzymes

in blood to generate an Aspartate aminotransferase-to-Platelet-

Ratio-Index (APRI) score tracks the progression of Hepatitis C

and development of cirrhosis. A different blood test under the

trade name “Fibrosure” measures other blood markers to

estimate liver damage.

Shortly after his transfer to FCI-Allenwood, medical staff

at the facility examined Bernier. They noted that Bernier had

been diagnosed with Hepatitis C and had undergone liver

biopsies and Fibrosure tests while in state custody. The liver

biopsies showed some tissue scarring that had not yet

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progressed to cirrhosis. The Fibrosure results, in contrast,

indicated that Bernier already had cirrhosis. The medical staff

at Allenwood began regularly measuring Bernier’s APRI score,

which indicated that some liver damage had occurred but had

not risen to the level of cirrhosis.

Bernier wanted to be treated with Harvoni. That relatively

new drug had proved highly effective in curing Hepatitis C in

patients similar to Bernier. But it came with a high price tag:

A full course of treatment with Harvoni at that time cost about

$94,000.

Speaking to the initial approval in 2013 to prescribe direct-

acting antivirals like Harvoni to treat Hepatitis C, a panel of

experts from the American Association for the Study of Liver

Disease and the Infectious Diseases Society of America

(IDSA/AASLD) noted that “knowledge about how these drugs

worked came from clinical trials,” and emphasized that the

profession “needed to gain experience with their safety before

we encouraged all infected persons to initiate therapy.”

Complaint ¶ 43. In the meantime, the expert panel

recommended that the drugs be prescribed only to patients with

the most serious need, such as those with severe liver disease

who otherwise had dwindling treatment options for grave

health conditions. Id.

Consistent with the original, more circumscribed

recommendation of the IDSA/AASLD expert panel, BOP

developed its initial prioritization protocol for treatment with

direct-acting antiviral drugs. Under that protocol, patients with

Hepatitis C were sorted into categories—Priority 1, 2, 3, or 4,

in descending order of severity of their liver damage and other

symptoms. See J.A. 127-28 (Complaint Exhibit B). BOP

institutions were encouraged to submit applications to treat

Priority 1 and 2 patients with direct-acting antivirals.

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Complaint ¶ 21. Applications would proceed “up the chain of

decisional authority” until the relevant BOP medical official

approved or denied the treatment. Id. ¶ 19.

In December 2015, medical staff at FCI-Allenwood

submitted a Non-Formulary Drug Authorization application to

the BOP seeking approval to treat Bernier with Harvoni. The

application noted that Bernier had chronic Hepatitis C. It

included his liver biopsy results and APRI score but—for

unknown reasons—did not include his Fibrosure results. See

J.A. 121 (Complaint Exhibit A). It also observed, based on the

biopsy and APRI results, that Bernier appeared to be Priority

3, so not the “highest” or even “high” priority for treatment. Id.

at 121, 128 (Complaint Exhibits A, B).

Decision on Bernier’s application rested with the Chief

Physician and Medical Director for BOP, Dr. Jeffery Allen.

There is no dispute that Bernier suffered from Hepatitis C, nor

that, pursuant to the Bureau of Prisons protocol then in place,

patients who did not yet have specified indicia of advanced-

stage liver disease placing them in Priority Category 1 or 2 did

not qualify for direct-acting antiviral treatment. On December

31, 2015, Allen denied Bernier’s application with brief

notations that appear to reference BOP’s then-applicable

prioritization protocol:

Treatment naive [Hepatitis C] with no evidence for

advanced liver disease. Current BOP priority level for

treatment are not met. Continue to monitor and

manage according to BOP guidelines and resubmit

request when BOP priority criteria are met.

J.A. 121 (Complaint Exhibit A). FCI-Allenwood’s Clinical

Director later elaborated on Allen’s reasoning, stating that,

“[b]ased on [Bernier’s] APRI he is designated as a Priority 3

patient,” and that at the time BOP was approving only Priority

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1 and Priority 2 patients for treatment with Harvoni. Complaint

¶ 21.

Acting pro se, Bernier filed suit in federal district court

here in 2016. As relief for his Eighth Amendment claim of

deliberate indifference to his serious medical needs, Bernier

sought to enjoin BOP to afford him treatment with Harvoni,

and sought damages from Dr. Allen pursuant to Bivens. See

Carlson v. Green, 446 U.S. 14, 17-18 (1980) (recognizing

availability of Bivens claims for Eighth Amendment violations

where prison officials fail to provide adequate medical

treatment).

Bernier claimed that the December 2015 treatment denial

amounted to deliberate indifference to his serious medical

needs in violation of clearly established Eighth Amendment

rights. Bernier’s complaint cited the latest IDSA/AASLD

guidance based on “expanded ‘real-world’ experience with the

tolerability and efficacy of newer [Hepatitis C virus]

medications,” which supported the use of direct-acting

antivirals for “nearly all patients with chronic Hepatitis C.”

J.A. 130 (Complaint Exhibit C) (formatting altered). The

expert panel no longer recommended prioritization only for

those patients who were already seriously ill. Id. The panel

recognized that “[b]ecause of the cost of the new drugs, or

regional availability of appropriate health care providers, a

practitioner may still need to decide which patients should be

treated first,” but emphasized that “the goal is to treat all

patients as promptly as feasible to improve health and to reduce

HCV transmission.” Id. (internal quotation omitted). And the

panel specifically heralded the promise of direct-acting

antiviral drugs for prisons, where Hepatitis C is common,

noting that “[c]oordinated treatment efforts within prison

systems would likely rapidly decrease the prevalence of HCV

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infection in this at-risk population . . . .” J.A. 142 (Complaint

Exhibit D).

In light of the new IDSA/AASLD guidance, Bernier

contended, Allen’s December decision could be understood

only as unconstitutionally based entirely on cost rather than

medical considerations. In support, he recited Harvoni’s high

cost to assail Dr. Allen’s failure to approve his December 2015

treatment request.

Bernier has since received treatment for his Hepatitis C

with Zepatier, a direct-acting antiviral drug similar to Harvoni.

In October 2016, BOP released an updated protocol that

broadened the criteria for Priority 2, making Bernier eligible

for treatment with Harvoni or an equivalent. Responding to a

renewed application on Bernier’s behalf, clinical staff in March

2017 authorized the requested treatment. Bernier’s treatment

with Zepatier, which began in April 2017, cured his Hepatitis

C infection. Complaint ¶¶ 24-25. He now seeks compensation

for having suffered the “painful symptoms and physiological

harm attributable to his disease, as well as . . . [the] substantial

risk of further serious harm” in the interim between his denied

application for Harvoni and the commencement of his

successful treatment with Zepatier. Complaint ¶ 26.

B. Legal framework

“‘Deliberate indifference to serious medical needs of

prisoners constitutes the unnecessary and wanton infliction of

pain . . . proscribed by the Eighth Amendment,’ and this

includes ‘indifference . . . manifested by prison doctors in their

response to the prisoner’s needs or by prison guards in

intentionally denying or delaying access to medical care.’”

Erickson v. Pardus, 551 U.S. 89, 90 (2007) (quoting Estelle v.

Gamble, 429 U.S. 97, 104-05 (1976)) (formatting altered).

Deliberate indifference includes subjective and objective

10

components; an official “must both be aware of facts from

which the inference could be drawn that a substantial risk of

serious harm exists, and he must also draw the inference.”

Farmer v. Brennan, 511 U.S. 825, 837 (1994). Moreover, not

“every claim by a prisoner that he has not received adequate

medical treatment states a violation of the Eighth

Amendment.” Estelle, 429 U.S. at 105. Mere inadvertent or

negligent failures to provide care do not amount to deliberate

indifference. Id. at 105-06. A complaint thus “must allege that

‘officials had subjective knowledge of the serious medical need

and recklessly disregarded the excessive risk to inmate health

or safety from that risk.’” Anderson v. District of Columbia,

810 F. App’x 4, 6 (D.C. Cir. 2020) (quoting Baker v. District

of Columbia, 326 F.3d 1302, 1306 (D.C. Cir. 2003)). There is

no dispute here that refusal to provide timely, available, and

appropriate treatment for a known, serious medical condition

posing excessive risk to an inmate’s health or safety would be

deliberate indifference in violation of the Eighth Amendment.

We assume without deciding that well-pleaded allegations

that a treatment decision was based exclusively on nonmedical

considerations such as cost or administrative convenience

rather than any medical justification can suffice to state an

Eighth Amendment deliberate indifference claim. We have not

directly spoken to this question, but other courts appear to

agree at least that cost or other nonmedical rationale cannot be

the only justification for prison officials’ treatment decisions—

including decisions affecting inmates with Hepatitis C. For

example, in evaluating a treatment protocol in the Florida

prison system, the Eleventh Circuit held that, while “the Eighth

Amendment does not prohibit prison officials from considering

cost . . . [,] cost can never be an absolute defense to what the

Constitution otherwise requires.” Hoffer v. Sec’y, Fla. Dep’t

of Corr., 973 F.3d 1263, 1277 (11th Cir. 2020). And even

before direct-acting antiviral drugs were available, the Seventh

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Circuit recognized the viability of a deliberate indifference

claim where application of an Illinois protocol regarding older

forms of Hepatitis C treatment was motivated by

“administrative convenience” and not “any real medical

reason.” Roe v. Elyea, 631 F.3d 843, 860 (7th Cir. 2011)

(formatting altered).

As relevant to this appeal, Allen defends based on

qualified immunity, which “protects government officials

‘from liability for civil damages insofar as their conduct does

not violate clearly established statutory or constitutional rights

of which a reasonable person would have known.’” Pearson v.

Callahan, 555 U.S. 223, 231 (2009) (quoting Harlow v.

Fitzgerald, 457 U.S. 800, 818 (1982)). “[T]he right allegedly

violated must be established, ‘not as a broad general

proposition,’ but in a ‘particularized’ sense so that the

‘contours’ of the right are clear to a reasonable official.”

Reichle v. Howards, 566 U.S. 658, 665 (2012) (first quoting

Brosseau v. Haugen, 543 U.S. 194, 198 (2004) (per curiam),

then quoting Anderson v. Creighton, 483 U.S. 635, 640

(1987)).

To be sufficiently clearly established, a right need not rest

on controlling authority directly on point, “but existing

precedent must have placed the statutory or constitutional

question beyond debate.” Ashcroft v. al-Kidd, 563 U.S. 731,

741 (2011). Qualified immunity may be unavailable when

plaintiffs identify “cases of controlling authority in their

jurisdiction at the time of the incident” or “a consensus of cases

of persuasive authority such that a reasonable officer could not

have believed that his actions were lawful.” Wilson v. Layne,

526 U.S. 603, 617 (1999).

Because qualified immunity provides “an immunity from

suit rather than a mere defense to liability,” Pearson, 555 U.S.

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at 231 (quoting Mitchell v. Forsyth, 472 U.S. 511, 526 (1985)),

the viability of a duly asserted qualified immunity defense

should be resolved “at the earliest possible stage in litigation,”

id. at 232 (quoting Hunter v. Bryant, 502 U.S. 224, 227 (1991)

(per curiam)). To prevent erroneously subjecting public

officials to the burdens of litigation, a defendant with a

plausible immunity defense is entitled to an immediate appeal

from a district court’s order denying it. See Mitchell, 472 U.S.

at 530.

C. Procedural history

Bernier’s initial complaint sought both injunctive relief

and damages against Allen and other government officials.

Once Bernier’s treatment with Zepatier proved successful, the

court dismissed the claim for injunctive relief as moot.

Meanwhile, over a period of 3 years, the district court struggled

to assess the viability of Bernier’s damages claim against Dr.

Allen in the face of Allen’s assertion of qualified immunity.

The court considered Allen’s three successive motions to

dismiss Bernier’s twice-amended complaint and Bernier’s

oppositions thereto, as well as Bernier’s motions for

reconsideration and to alter or amend the judgment. In the

February 2021 order from which Allen appeals, the court

decided that Bernier had stated a sufficiently clearly

established Eighth Amendment damages claim to surmount

Allen’s pleading-stage assertion of qualified immunity.

The district court held that Bernier’s complaint stated a

clearly established Eighth Amendment claim in two distinct

ways. The court first considered Bernier’s allegations that

BOP’s protocol served “to minimize the high cost attending the

administration of drugs such as Harvoni,” and lacked “any

medical justification.” Bernier v. Allen (Bernier 2020), No. 16-

CV-00828, 2020 WL 4047953, at *5 (D.D.C. July 20, 2020)

13

(quoting Complaint ¶ 22). Because the district court concluded

that the Eighth Amendment clearly prohibits denying

necessary treatment “purely for non-medical reasons such as

cost,” the court allowed Bernier to proceed to discovery to seek

to substantiate that theory. Id.; see id. at *5-*6; Bernier v. Allen

(Bernier 2021), No. 16-CV-00828, 2021 WL 1396375, at *1

(D.D.C. Feb. 8, 2021) (district court reaffirming that

conclusion).

The court also noted that Dr. Allen was allegedly aware of

Bernier’s Fibrosure result showing cirrhosis yet disregarded it

when he denied the requested treatment in December 2015.

See Bernier 2020, 2020 WL 4047953, at *5 (citing Complaint

¶ 21). The court recognized that prison officials with

knowledge of an inmate’s serious medical needs may exhibit

deliberate indifference in violation of the Eighth Amendment

when they eschew medically recommended treatment in

conscious disregard of excessive health risks. Id. at *6-*8

(citing, e.g., United States v. Fitzgerald, 466 F.2d 377, 380 n.6

(D.C. Cir. 1972)). If medical records in BOP’s hands included

test results indicating that Bernier had cirrhosis, the district

court reasoned, Allen’s disregard of “the BOP’s own treatment

recommendations” in its unamended protocol would amount to

deliberate indifference. Id. at *6. The court acknowledged that

Bernier had not directly asserted that “he was entitled to a

higher priority level based on his Fibrosure test result,” but

granted him “the benefit of the doubt” that he was invoking this

second theory in support of his Eighth Amendment claim. Id.

at *6 n.5; see also Bernier 2021, 2021 WL 1396375, at *2

(district court reaffirming that conclusion). Allen timely

appealed.

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D. Jurisdiction and standard of review

We have jurisdiction to review final decisions of the

district court. 28 U.S.C. § 1291. “Provided it ‘turns on an issue

of law,’ . . . a district court’s order rejecting qualified immunity

at the motion-to-dismiss stage of a proceeding is a ‘final

decision’ within the meaning of § 1291.” Ashcroft v. Iqbal, 556

U.S. 662, 672 (2009) (quoting Mitchell, 472 U.S. at 530). Our

review of the district court’s decision to deny qualified

immunity is de novo. See Youngbey v. March, 676 F.3d 1114,

1117 (D.C. Cir. 2012).

ANALYSIS

A. We first address the distinct basis for Bernier’s Eighth

Amendment claim that the district court gleaned but that

Bernier himself had not clearly pressed: that Dr. Allen denied

the application for Harvoni treatment in knowing disregard of

Bernier’s Fibrosure test result showing he had cirrhosis.

Bernier’s complaint alleged that his Fibrosure result indicated

cirrhosis. It also alleged that, under BOP policy, medical

evidence of cirrhosis might render unnecessary other

diagnostic measures of Hepatitis C’s progression—like the

APRI scores and biopsy results Allen reviewed to conclude that

Bernier’s Hepatitis was less serious. See Complaint ¶¶ 39, 46.

The district court thought it plausible that, if Allen knew

of the Fibrosure result, proper consideration of that result might

have required him to view Bernier’s medical needs as urgent

even though other test results indicated otherwise. If a fully

informed medical assessment would have concluded that

Bernier in fact already had cirrhosis, he should have been

placed in the Priority 1 or Priority 2 category even under the

initial BOP protocol. Treating him as lower priority might well

amount to deliberate indifference to a serious medical

15

condition. The district court thus decided to give Bernier “the

benefit of the doubt” that Dr. Allen was aware of a test result

showing that Bernier deserved a “higher priority treatment

category” when he denied the application, Bernier 2020, 2020

WL 4047953, at *6 n.5, so relied in part on this ground to deny

the motion to dismiss.

Bernier has made clear, however, that he is not advancing

that distinct theory. Notably, Bernier’s complaint did not

allege that he was wrongly classified into Priority 3 at the time

of his December 2015 request. See id. He has since clarified

that he is not asserting that he in fact already had cirrhosis, so

does not claim that denial of Harvoni before the expert panel

released its updated recommendation in October 2015 would

have amounted to deliberate indifference. And at oral

argument his counsel confirmed that, even were we to credit

the allegation that Dr. Allen knew of Bernier’s Fibrosure result,

Bernier does not claim that he should have been classified as

other than Priority 3 (ineligible) under the then-applicable

version of BOP’s prioritization protocol. See Oral Arg. Rec.

42:26-43:59.

B. Bernier’s sole theory on appeal, then, is that Dr. Allen

was deliberately indifferent in denying the application for

Harvoni “in reliance upon a prioritization protocol no longer

consistent with accepted professional medical judgment and

based entirely upon an intent to minimize costs.” Complaint

¶ 46. We conclude that Bernier’s allegations fail to plausibly

support that inference, and that Allen’s decision did not violate

clearly established Eighth Amendment law. Accordingly, we

hold that qualified immunity shields Allen from Bernier’s

claim for damages.

We begin with the contention that Dr. Allen’s decision to

deny the application for Harvoni was entirely cost-based.

16

Bernier alleges two facts to support that contention: the bare

fact that Harvoni was expensive, and the issuance two months

earlier of the expert panel report modifying its position to

recommend direct-acting antiviral drugs as safe and effective

for Hepatitis C patients at all stages of the disease. See

Appellant Br. 17-22; Complaint ¶¶ 38, 46. But the complaint’s

Exhibit A belies that contention by providing the decidedly

medical reasoning that Dr. Allen gave for his decision to deny

Bernier’s application for Harvoni.

Allen’s written decision reflects an individualized

determination about Bernier’s circumstances and need. It

specifically identifies the nature of Bernier’s health issue

(“HCV-1a”), his treatment history (“[t]reatment naive”), and

the virus’s stage of progression (“no evidence for advanced

liver disease”). J.A. 121 (Complaint Exhibit A). The

decision’s express invocation of medical considerations

significantly undermines the plausibility of inferring that Allen

denied Bernier’s application solely because of Harvoni’s high

cost.

Bernier insists, however, that Dr. Allen acted with

deliberate indifference because he referenced BOP’s

unamended prioritization protocol. Specifically, he argues

that, once the medical consensus shifted in October 2015 and

effectively updated the standard of care for patients with

Hepatitis C, Allen’s continued reference to the existing

protocol’s treatment categories constituted deliberate

indifference. See Complaint ¶¶ 46-47. In Bernier’s view,

Allen should have immediately approved the application for

Harvoni in accordance with the October 2015 IDSA/AASLD

panel report’s recommendation that all Hepatitis C patients

receive treatment with direct-acting antivirals. Bernier asserts

that Allen’s denial, with reference to the protocol’s priority

rubric, amounted to a violation of the Eighth Amendment.

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In effect, then, Bernier’s claim is that he had a

constitutional right to treatment with the direct-acting antiviral

drug Harvoni at the time of his December 2015 application.

Bernier is no longer seeking an injunction requiring the BOP

to treat him with Harvoni, and we accordingly do not decide

the distinct question how such a claim might be affected by the

updated standard of care. Here, Bernier seeks to overcome Dr.

Allen’s assertion of qualified immunity in pursuit of his

damages claim, and his burden is correspondingly higher. His

allegations must plausibly establish the inference that Dr.

Allen’s decision not only violated a right to treatment for a

serious medical need, but a clearly established one. See Iqbal,

556 U.S. at 673, 682. To defeat Allen’s assertion of qualified

immunity, Bernier must point to “existing precedent” that

places the relevant “constitutional question beyond debate.”

al-Kidd, 563 U.S. at 741 (citation omitted). The relevant

question in this case is whether Bernier, as his health stood at

the time, was constitutionally entitled to treatment with

Harvoni within two months of the medical community deciding

it was appropriate for lower-risk patients like him to receive it.

Whatever the right answer is to that question, we cannot

conclude that existing law in December 2015 made it clear.

Bernier does not identify—and we are not aware of—any

controlling precedent from the Supreme Court or our circuit

that affirmatively identifies that right “in a particularized sense

so that [its contours] are clear to a reasonable official.” Reichle,

566 U.S. at 665 (internal quotation omitted). Nor is there “a

consensus of cases of persuasive authority such that [Dr. Allen]

could not have believed that” it was medically appropriate to

deny Bernier’s application for Harvoni. Wilson, 526 U.S. at

617. Indeed, in response to a question at oral argument about

how quickly prison medical authorities are required to conform

their actions to a new standard of care to avoid Eighth

Amendment liability for deliberate indifference, Bernier’s

18

counsel candidly acknowledged that “the case law that has

emerged since the direct-acting antiviral medications came to

the fore has been quite variable with regard to the views of

courts in terms of how quickly implementation should have

taken place, so I do not have a definitive answer.” Oral Arg.

Rec. at 40:43-41:25; see also Appellee Br. at 21 (recognizing

the expert panel’s acknowledgement “that implementation of

the new [standard of care] might not be instantaneous”).

Especially since Bernier acknowledges that he was correctly

classified as Priority 3 when his application was denied, the

lack of a definitive answer here is dispositive: No clearly

established law guaranteed his right to treatment with direct-

acting antiviral drugs at the time of his application.

Bernier seeks to meet the requirement that he identify

clearly established law that Dr. Allen violated by citing to three

out-of-circuit cases, which he argues support the proposition

that corrections officials sued under the Eighth Amendment are

not entitled to qualified immunity when they deny prisoners

Hepatitis C treatment “on the basis of implementation of

bureaucratic administrative policies not having a specific basis

in governing medical standards.” Appellee Br. at 14; see id. at

13-14 (citing Elyea, 631 F.3d at 858-61; Johnson v. Wright,

412 F.3d 398, 404-06 (2d Cir. 2005); McKenna v. Wright, 386

F.3d 432, 435-37 (2d Cir. 2004)). But those decisions do not

support the type of claim Bernier asserts. Their reasoning thus

does not undercut Dr. Allen’s assertion of qualified immunity.

In Roe v. Elyea, for example, the Seventh Circuit upheld a

jury’s verdict that the prison medical director’s “failure to

consider an individual inmate’s condition in making treatment

decisions” amounted to deliberate indifference to the inmate’s

advanced liver disease. 631 F.3d at 862. In 2004, Dr. Elyea

denied Roe access to testing and a pre-Harvoni form of

antiviral therapy for Hepatitis C. Id. at 851. The doctor relied

19

on an Illinois Department of Corrections protocol that rendered

inmates with fewer than eighteen months still to serve in prison

ineligible for Hepatitis C testing and treatment. Id. at 850.

Defendants contended the protocol was justified to ensure that

inmates who began a course of treatment could complete it. Id.

Dr. Elyea adhered to that protocol despite knowledge of Roe’s

advanced-stage liver disease, and even though he knew that

patients with Roe’s genotype could be treated in half the time.

Id. at 850-51. Roe died before he was afforded the treatment

he sought. Id. at 851. In rejecting the qualified immunity

defense, the court noted Dr. Elyea’s acknowledgement that

“there may not have been any real medical reason” for the

protocol’s uniform approach across genotypes “other than to

keep it simple.” Id. at 863.

The two cases from the Second Circuit similarly held

qualified immunity inapplicable where state prison officials’

reliance on treatment protocols led them to deny appropriate

treatment to Hepatitis C patients in disregard of known, serious

health risks. The defendant officials in Johnson v. Wright

denied treatment pursuant to a New York State Department of

Corrections policy forbidding Hepatitis C medication to any

patient with evidence of active substance abuse within the

preceding two years. 412 F.3d at 400. Based on one urine test

a year earlier showing marijuana use, defendants had

“reflexively follow[ed] the Guideline’s substance abuse policy

in the face of the unanimous, express, and repeated

recommendations of plaintiff’s treating physicians,” id. at 406,

that Johnson needed medication and should receive it “in spite

of [the] drug policy,” id. at 402 (internal quotation omitted).

The policy rested on an interest in avoiding potentially toxic

interactions between prescribed treatments and abused

substances and concerns that patients abusing drugs and

alcohol might miss appointments or otherwise fail to adhere to

the treatment regimen. Id. at 405. But apprehensions about

20

alcohol or narcotics contributing to liver damage concededly

did not apply to Johnson’s limited marijuana use. Id. And the

court held that a jury could have found compliance concerns

likewise inapplicable because of Johnson’s record of

compliance with an earlier treatment regimen. Id. at 405-06.

The court of appeals thus held summary judgment unwarranted

because a jury could reasonably find that the defendants knew

of but acted with deliberate indifference to “an excessive risk

to Johnson’s health.” Id. at 406.

The Second Circuit in McKenna likewise denied prison

officials qualified immunity from an Eighth Amendment

deliberate-indifference claim. 386 F.3d at 437. Defendants

allegedly withheld urgently needed Hepatitis C treatment for

which McKenna would otherwise be eligible, relying in part on

the possibility that he might be paroled from his four-year

sentence before the twelve months of treatment could be

completed and thus add to systemic “risk of the development

and spread of untreatable HCV.” Id. (quotations omitted). In

denying treatment, the defendants also cited McKenna’s failure

to enroll in an alcohol and substance abuse treatment program

even though they had deemed him ineligible for that very

program due to his medical condition, id. at 434, and objected

that his “cirrhosis was decompensated, i.e., accompanied by

various complications,” even though they turned down his

request for a liver transplant “because the cirrhosis was

probably compensated,” id. The complaint alleged “a series of

failures to test for [McKenna’s] condition despite known

danger signs of his disease, failure to initiate treatment when

the need for treatment was apparent, failure to send McKenna

for follow-up visits ordered by doctors,” as well as “denial of

treatment based on inapplicable and flawed policies” occurring

over a period of more than four years. Id. at 437. By the time

defendants authorized the care McKenna sought, “his disease

was so advanced that the side effects rendered him too weak to

21

continue treatment.” Id. at 435. The district court correctly

denied the defendant officials’ motion to dismiss because the

allegations showed their reliance on prison policies was not

objectively reasonable under the circumstances. Id. at 437. In

particular, the court held that denial of “urgently needed

treatment for a serious disease because [the patient] might be

released within twelve months of starting the treatment

sufficiently alleges deliberate indifference” to overcome

qualified immunity. Id.

We cannot conclude based on the cases on which Bernier

relies that there is any “consensus of cases of persuasive

authority” in support of his particular claim. Wilson, 526 U.S.

at 617. Unlike in those cases, there is no plausible allegation

here of any deliberate or reckless delay or any disregard of

exacerbating symptoms. Whether a prison official acts with

deliberate indifference depends in part on the severity of the

inmate’s medical needs. See Estelle, 429 U.S. at 104. Despite

his Fibrosure results, Bernier does not contend that he in fact

had cirrhosis when his application was denied. Oral Arg. Rec.

at 43:38-59. Bernier’s Hepatitis C was then in relatively early

stages, and his medical condition was generally stable. Indeed,

Bernier acknowledges that in December 2015 he was correctly

categorized into Priority 3 under the protocol. Id. at 42:26-52.

As such, he was at lower “risk for complications or disease

progression” and required less “urgent consideration for

treatment” than Priority 1 or 2 patients. Complaint ¶ 21; see

also Bernier v. Koenigsmann, No. 9:17-CV-0254, 2021 WL

2269839, at * 12 (N.D.N.Y. May 13, 2021) (finding in a

separate case related to Bernier’s incarceration in state prison

that the uncontradicted opinion of Bernier’s treating physicians

was that, as of April 2015, his “condition was stable, and there

was no urgent need to rush treatment”). That makes Bernier’s

situation unlike one where, for example, an inmate’s test results

revealed the immediate need to forestall grave harm, requiring

22

speedier action by prison officials like Dr. Allen to approve

even a newly recommended treatment.

Nor did any of the cases Bernier cites recognize a clearly

established right of a patient under medical management of a

serious disease, monitored and apparently stable, immediately

to receive the most recently recommended treatment within just

a few weeks of its clinical acceptance as appropriate. Rather,

the treatment denial in those cases rested on protocols that

focused in bluntly categorical ways on public health concerns

at the expense of the individual’s known, urgent need for

treatment for a serious medical condition, or reflected

considerations of administrative convenience that directly

conflicted with similarly grave individual health needs.

By contrast, the protocol in this case, while just recently

outdated in its classification system, expressly instructed BOP

medical officials to make “[e]xceptions” to the regular priority

system “on an individual basis . . . [,] determined primarily by

a compelling or urgent need for treatment, such as evidence for

rapid progression of fibrosis, or deteriorating health status from

other comorbidities.” J.A. 128 (Complaint Exhibit B). As

discussed above, Dr. Allen’s decision relying on BOP’s

protocol here did in fact make an individualized medical

determination about Bernier’s needs—considering the stable

nature and relatively low urgency of Bernier’s case—before

concluding that treatment with Harvoni was not then

warranted. Having done so, “a reasonable officer” in Dr.

Allen’s position could accordingly “have believed that his

actions were lawful,” even assuming that he was bound by the

three out-of-circuit decisions Bernier cites. Wilson, 526 U.S.

at 617.

23

We therefore hold that qualified immunity protects Dr.

Allen from personal liability for damages based on his

December 2015 treatment decision in Bernier’s case.

* * *

Accordingly, we reverse the district court’s denial of

qualified immunity to Allen.

So ordered.

SILBERMAN, Senior Circuit Judge, concurring in the

judgment: Like the majority, I would reverse the district

court’s denial of qualified immunity to Dr. Allen. I write

separately because I think it is clear that Bernier has not stated

an Eighth Amendment violation, whether or not it is clearly

established in the case law.

Bernier’s theory on appeal is that Dr. Allen was

deliberately indifferent in denying his application for the anti-

viral drug, Harvoni. Bernier claims he was constitutionally

entitled to Harvoni for his Hepatitis C and that Dr. Allen

illegitimately relied entirely on cost to deny the drug promptly.

See Complaint ¶ 46. As the majority notes, the relevant

question here is “whether Bernier, as his health stood at the

time, was constitutionally entitled to treatment with Harvoni

within two months of the medical community deciding it was

appropriate for lower-risk patients like him to receive it.”

Supra at 17. The majority concludes that, “[w]hatever the right

answer is to that question,” Bernier cannot overcome qualified

immunity because the right he articulates is not clearly

established. Supra at 17–18.

I think that the right answer—and therefore the

theoretically clearly established one—to the question the

majority raises is clearly ‘no’ as a matter of law.

The majority states that “[t]here is no dispute here that

refusal to provide timely, available, and appropriate treatment

for a known, serious medical condition posing excessive risk

to an inmate’s health or safety would be deliberate indifference

in violation of the Eighth Amendment.” Supra at 10. I do not

agree with that statement. I think it’s too broad. In the same

vein, the majority opinion goes on to say that “[w]e assume

without deciding that well-pleaded allegations that a treatment

decision was based exclusively on nonmedical considerations

such as cost or administrative convenience rather that any

medical justification can suffice to state an Eighth Amendment

2

deliberate indifference claim.” Supra at 10. I reject that

assumption. It is also an overstatement.

We must bear in mind that the constitutional provision we

are applying is the Eighth Amendment, which, in relevant part,

bans the infliction of “cruel and unusual punishments.” U.S.

CONST. amend. VIII (emphasis added). It does not guarantee

state-of-the-art medical care for prisoners. A federal prison is

not a Johns Hopkins Hospital. It appears that some of our sister

circuits have lost sight of that fundamental concept in their

implementation of the deliberate indifference standard first

articulated in Estelle v. Gamble, 429 U.S. 97, 104–05 (1976).

See, e.g., Abu-Jamal v. Kerestes, 779 F. App’x 893, 900 (3rd

Cir. 2019); Johnson v. Wright, 412 F.3d 398, 404–06 (2nd Cir.

2005).

My view is that in any case in which there is an allegation

that a federal prisoner has suffered an Eighth Amendment

violation because of deliberate indifference to his or her serious

medical needs, the issue before the court is a balancing

question. The government is entitled to balance administrative

considerations, including cost, against medical need. Still, the

threshold question is whether there is a severe medical need.

In the absence of such a need, even minor administrative

considerations would suffice to deny treatment.

Indeed, in Estelle, Justice Marshall made clear that not

“every claim by a prisoner that he has not received adequate

medical treatment states a violation of the Eighth

Amendment.” Id. at 105. He carefully distinguished medical

malpractice from an Eighth Amendment violation. Id. at 105–

06. That means that medical treatment of an inmate that could

be criticized as merely “inappropriate” does not constitute an

Eighth Amendment violation.

3

I think the Eleventh Circuit got it right in Hoffer v.

Secretary, Florida Department of Corrections. 973 F.3d 1263

(11th Cir. 2020). It said that medical treatment violates the

Eighth Amendment “only when it is so grossly incompetent,

inadequate, or excessive as to shock the conscience.” Id. at

1271 (quotations omitted). In other words, in its view, the

Eighth Amendment only requires a minimally adequate level

of care. I agree with their “commonsense notion” that “the

civilized minimum level of care required by the Eighth

Amendment is a function both of objective need and cost.” Id.

at 1276 (quotations omitted). “The more serious and exigent

an inmate’s need, the more likely it is that ‘the civilized

minimum’ might be deemed to require expensive treatment—

and vice versa.” Id. So, prison officials may consider cost in

“determining what type (or level) of medical care inmates

should receive.” Id. at 1277.

Accordingly, as I’ve indicated, it is too sweeping for the

majority to assert that “refusal to provide, timely, available and

appropriate treatment for a known, serious medical condition

posing excessive risk to an inmate’s health or safety” would

necessarily constitute deliberate indifference. “Appropriate

treatment” is a medical malpractice concept, which exceeds the

government’s obligation to provide minimally adequate care.

Once that standard is met, refusal to provide a particular

treatment that is “available and appropriate”—even for a

serious condition—is constitutionally permissible. As the

Eleventh Circuit stated, “diagnosing, monitoring, and

managing conditions—even where a complete cure may be

available—will often meet the ‘minimally adequate medical

care’ standard that the Eighth Amendment imposes.” Id. at

1273.

Moreover, an allegation that a treatment decision was

based solely on cost does not by itself suffice to state a

4

deliberate indifference claim. The majority quotes one

sentence in the Eleventh Circuit’s opinion for the proposition

that, while “the Eighth Amendment does not prohibit prison

officials from considering cost . . . [,] cost can never be an

absolute defense to what the Constitution otherwise requires,”

id. at 1277, to support its assertion that cost “cannot be the only

justification for prison officials’ treatment decisions,” supra at

10. But that sentence alone is quoted out of context. The

Eleventh Circuit immediately thereafter stated that, “[p]ut

differently, if a particular course of treatment is indeed

essential to ‘minimally adequate care,’ prison authorities can’t

plead poverty as an excuse for refusing to provide it.” Id. at

1277. By implication, a federal prison can deny a particular

course of treatment—i.e. one that exceeds the constitutional

minimum—based exclusively on cost, so long as it provides

minimally adequate care. Thus, a prisoner must do more than

allege that a treatment decision was based exclusively on cost

to state a deliberate indifference claim.

In other words, unless an inmate is facing a serious

medical problem, almost any administrative or cost

considerations can dictate the prison’s response. And, even if

an inmate does face a serious medical problem, administrative

and cost considerations can outweigh his or her entitlement to

a particular treatment, so long as the constitutional minimum is

met.

It is obvious that Bernier was not constitutionally entitled

to the enormously expensive Harvoni within two months of the

medical community deciding it was appropriate for lower-risk

patients like him. Harvoni is a state-of-the-art direct-acting

antiviral drug that completely cures Hepatitis C. Bernier does

not plausibly allege deliberate or reckless delay by Dr. Allen or

disregard of disease progression. In fact, Bernier does not

claim that he has cirrhosis and does not contest his placement

5

into Priority 3 under the prison’s treatment protocol. In sum,

Bernier has not met the threshold to trigger the deliberate

indifference balancing test; he was not facing a serious medical

risk.

Even if he had met the threshold, Bernier was in stable

condition, the prison was managing his Hepatitis C, and Dr.

Allen was monitoring Bernier’s condition and applying a

treatment protocol based on risk for complications or disease

progression. Dr. Allen even made an individualized medical

determination before denying Bernier’s request for treatment

with Harvoni. Indeed, Dr. Allen’s decision would have been

justified in these circumstances even if he had relied purely on

cost to deny Bernier treatment with Harvoni. Dr. Allen has

provided minimally adequate care and the right Bernier claims

far exceeds that constitutional minimum. Accordingly, Dr.

Allen’s conduct does not constitute deliberate indifference.

Because it is so clear that Bernier has not stated a cause of

action plausibly alleging an Eighth Amendment violation, we

should forthrightly so conclude. 1

1

At times the majority opinion seems to veer back and forth

between agreeing that there is no violation here and that the right

Bernier asserts is not clearly established. See supra at 21–23.

Indeed, the majority analyzes the facts and allegations in much the

same way I do and approaches the same conclusion. Nevertheless,

the majority rests its conclusion on the clearly established prong of

qualified immunity.