Court Opinion

ID: 6497713
Source: CourtListenerOpinion
Date Created: 2022-07-05 15:00:37.814167+00
Date Added: 2024-06-11T08:51:24.181139
License: Public Domain

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.
                                2
    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
                               3
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
                                4
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
                                5
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
                                6
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.
                                7
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
                               8
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
                                 9
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
                               11
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.
                               12
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.
                                14
    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.
                                17
     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.