BUFFKIN et al v. HOOKS et al
Filing
38
MEMORANDUM OPINION AND RECOMMENDATION OF UNITED STATES MAGISTRATE JUDGE signed by MAG/JUDGE JOE L. WEBSTER on 11/30/2018, that Plaintiff's Motion to Certify Class (Docket Entry 3 ) be GRANTED and the class be defined as "all current and future prisoners in DPS custody who have or will have chronic hepatitis C virus and have not been treated with direct-acting antiviral drugs." FURTHER RECOMMENDED that Lloyd Buffkin and Robert Parham be nam ed as class representatives and that Plaintiffs' counsel be appointed as class counsel. FURTHER RECOMMENDED that Plaintiffs' Motion for Preliminary Injunction (Docket Entry 26 ) be GRANTED and a preliminary injunction be issued ordering Defendants to: (1) provide universal opt-out HCV screening to all persons who are or will be in DPS custody; (2) cease denying DAA treatment for the contraindications, other than patient refusal, set out in Step 4a of DPS Policy #CP-7; and (3) treat Plaintiffs and all members of their class with DAAs according to the current standard of medical care set out in the AASLD/IDSA Guidance, regardless of an individual's fibrosis level. (Garland, Leah)
IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF NORTH CAROLINA
LLOYD BUFFKIN, et al.,
Plaintiffs,
v.
ERIK HOOKS, et al.,
Defendants.
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)
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)
)
)
)
)
)
1:18CV502
MEMORANDUM OPINION AND RECOMMENDATION
OF UNITED STATES MAGISTRATE JUDGE
This matter is before the Court on Plaintiffs Lloyd Buffkin, Kim Caldwell, and Robert
Parham’s (collectively “Plaintiffs”) Motion to Certify Class (Docket Entry 3) and Motion for
a Preliminary Injunction. (Docket Entry 26.) Defendants Erik Hooks, Abhay Agarwal,
Kenneth Lassiter, Paula Smith, and the North Carolina Department of Public Safety
(collectively “Defendants”) have filed responses to both motions. (Docket Entries 31, 32.)
Plaintiffs thereafter filed replies. (Docket Entries 34, 35.) By request of Plaintiffs, a hearing
was held in this matter on October 29, 2018 regarding Plaintiffs’ motion for a preliminary
injunction. (Minute Entry dated 10/29/2018.) A week later, a second hearing was held on
Plaintiffs’ motion to certify the class. (Minute Entry dated 11/5/2018.) For the reasons stated
herein, the undersigned recommends that both motions be granted.
I.
BACKGROUND
According to the Complaint, Plaintiffs, currently incarcerated by the North Carolina
Department of Public Safety (“DPS”), all have been diagnosed with Hepatitis C Virus
1
(“HCV”) infection, a highly communicable disease that scars the liver and presents risks of
cancer, portal hypertension, excruciating pain, and death. (Compl. ¶ 1, Docket Entry 1.)
According to the opinion of Dr. Andrew Muir,1 common methods of HCV transmission
include intravenous drug use and receipt of blood products or organs before universal testing
of donors. (Muir Am. Aff. ¶ 8.) Initial exposure is generally asymptomatic for those infected
with HCV; however, nearly 80% of patients exposed to HCV will develop chronic HCV. (Id.
¶ 9.) During the chronic infection phase, patients slowly develop scarring or fibrosis of the
liver, and may eventually lead to significant liver scarring, called cirrhosis. (Id.) At that stage,
patients are at risk of painful and life-threatening complications that often require invasive and
painful treatments. (Id. ¶ 11.) Additionally, all patients with cirrhosis from HCV are at risk
for the development of liver cancer or hepatocellular carcinoma (“HCC”). (Id. ¶ 12.) If a
patient is not treated with direct-acting antiviral drugs (“DAAs”) before cirrhosis occurs, the
patient’s fibrosis may be irreversible. (Id.)
Proper screening for HCV is required to diagnose patients prior to the development
of the complications of cirrhosis and liver cancer. (Id. ¶ 13.) Failure to identify HCV at its
early stages of disease places patients at risk for the development of the life-threatening
complications of portal hypertension and liver cancer. (Id.) The initial test for HCV screening
or diagnostic evaluation is a blood test for the HCV antibody. (Id. ¶ 14.) A blood test for
HCV RNA confirms the presence of active HCV infection. (Id.)
1
Plaintiffs rely upon the affidavit of Dr. Andrew Muir, a board-certified gastroenterologist and Chief
of the Division of Gastroenterology at Duke University, to consult on Defendants’ policies and
practices regarding HCV, and to provide some background information regarding HCV. (See generally,
Compl. ¶¶ 22-51; Muir Aff., Docket Entry 1-1; see also Muir Am. Aff., Docket Entry 27-1.)
2
The American Association for the Study of Liver Diseases (“AASLD”) and Infectious
Diseases Society of America (“IDSA”) Guidance recommends screening for certain persons,
including persons who were ever incarcerated. (Id. ¶ 15.) Incarcerated populations have higher
rates of HCV than the general population. An estimated 16-41% of incarcerated persons in
North America are positive for antibodies against HCV. (Id. ¶ 16.) This data supports the
recommendation that all persons who were ever incarcerated be tested. (Id.) Data also
suggests that treatment of incarcerated persons helps the incarcerated population but also has
public health benefits by averting infections that would have occurred after the individuals are
released from prison. (Id.) HCV screening would likely diagnose 42,000-91,000 new HCV
cases in the next 30 years in prisons; if treatment is administered, prisons could prevent 4,20011,700 liver-related deaths. (Id.)
Once a patient is exposed to HCV, approximately 15-20% of people will clear infection
spontaneously. (Id. ¶ 18.) If the patient has HCV RNA detected more than 6 months after
exposure, the patient has chronic HCV infection. (Id.) Chronic HCV requires an assessment
of fibrosis, which develops slowly over the course of years. (Id. ¶¶ 19-20.) The most
commonly used scoring system for fibrosis is a scale of 0 (no fibrosis) to 4 (cirrhosis). (Id. ¶
20.) When a patient develops chronic HCV, the disease will almost certainly progress until
the infection is cleared or the patient dies. (Id. ¶ 23.) In 2007, HCV mortality rates in the
United States surpassed deaths from HIV infection.2 (Id. ¶ 24.) A critical component of a
2
According to the Centers for Disease Control and Prevention (“CDC”), the “annual hepatitis Crelated mortality in 2013 surpassed the total combined number of deaths from 60 other infectious
diseases reported to CDC, including HIV, pneumococcal disease, and tuberculosis.” Centers for
Disease Control and Prevention, Hepatitis C Kills More Americans than Any Other Infectious Disease,
3
strategy to reduce this risk of early mortality would be early treatment prior to the development
of cirrhosis. (Id.)
A commonly available fibrosis assessment mechanism is FibroSure, which can report
specific stages from 0 to 4. (Id. ¶ 27.) However, assessments of test characteristics reveal that
they cannot do so with consistent accuracy. (Id.) The weakness in these tests has made it
difficult to assess fibrosis progression over time with confidence in an individual patient. (Id.)
The test performs better in their assessment of advance fibrosis or cirrhosis. (Id.) The test
characteristics are modest with sensitivity for detecting significant fibrosis reported at 60-75%
with specificity 80-90%. (Id.)
For more than two decades, HCV treatment involved regimes that included interferonalpha. (Id. ¶ 29.) As a result of the numerous side effects including severe flu-like symptoms,
anxiety, and depression, many patients discontinued treatment. (Id.) In 2013, DAAs become
available and produced high efficacy rates. (Id. ¶ 30.) Interferon-based regimes were no longer
recommended for HCV treatment by the AASLD/IDSA Guidance panel. (Id.)
In the instant action, Plaintiffs have sought specific medical treatment, DAAs, to treat
their HCV infection. (Compl. ¶ 2.) Notwithstanding inmates infected with Hepatitis B or
HIV, current DPS policy permits only individuals with significant fibrosis to receive DAA
treatment. (Id. ¶¶ 3, 25, 95.) DPS uses a FibroSure test to determine a patient’s level of
fibrosis; a score of F2 demonstrates significant fibrosis, a score of F3 demonstrates severe
fibrosis, and F4 is cirrhosis, which is the most severe fibrosis. (Id. ¶ 33.) Inmates with a score
available at https://www.cdc.gov/media/releases/2016/p0504-hepc-mortality.html (last visited
November 28, 2018).
4
of F2 or higher are permitted to receive DAA treatment.3 (Id. ¶ 95.) As previously indicated,
the adequacy of the FibroSure test is poor, and even those inmates with significant liver
scarring may not receive DAA treatment if certain contraindications are present. (Id. ¶¶ 5, 34.)
Plaintiffs argue that the restrictions in the DPS policy are not medically justified. (Id. ¶ 5.)
The named Plaintiffs in this action are Lloyd Buffkin, Robert Parham, and Kim
Caldwell. (Id. ¶¶ 13-15.) At the time of the filing of the Complaint, all three prisoners had
been diagnosed with HCV and had not been treated for it. (Id.) Buffkin has been incarcerated
since July of 2013 and was diagnosed with HCV in August of 2017. (Id. ¶¶ 52-53.) In July of
2017, he registered a FibroSure score of F1-F2. (Id. ¶ 54.) Parham has been incarcerated since
October 2008 and has lived with chronic HCV for more than 20 years. (Id. ¶¶ 62-63.) Lab
records from January 2018 show a score of F1-F2. (Id. ¶ 65.) Caldwell has been incarcerated
since July of 2015 and he was diagnosed with HCV in 2015 while in DPS custody. (Id. ¶¶ 7374.) From 2015 up until the filing of the Complaint, Caldwell had not undergone any followup testing to determine the extent of his disease. (Id. ¶ 75.) After this action was filed, Caldwell
began DAA treatment. (See Docket Entry 32 at 16 n.1.)
All of the above-named Plaintiffs challenge the DPS Screening and Treatment Policy
(“Policy #CP-7”) regarding the detection, evaluation, and treatment of HCV in North
Carolina’s prisons. (Compl. ¶ 79.) Currently Policy #CP-7 does not provide for universal
screening of all prisoners for HCV. (Id. ¶ 80.) DPS relies upon a risk-based assessment in
which prison medical officials may order testing after consideration of certain risk factors but
3
Policy #CP-7 permits inmates with an FibroSure score below F2 to receive DAA medication if they
also have HIV or Hepatitis B. (Compl. ¶ 95.)
5
there are no circumstances which require that anyone be tested. (Id. ¶ 81.) Plaintiffs argue
that this risk-based assessment falls short of the guidance from the AASLD/IDSA which
constitute the current standard of care for HCV screening. (Id. ¶¶ 36, 82.) Plaintiffs argue
that because of DPS’s risk-based assessment approach to HCV, there are essentially thousands
of prisoners who have HCV and who have not been diagnosed. (Id.)
After initial screening, Policy #CP-7 sets forth additional directives for medical
officials, including performing physical examinations, obtain medical history information, lab
testing, and pretreatment evaluations.
(Id. ¶¶ 83-84.)
Policy #CP-7 then requires a
determination of whether treatment is contraindicated. (Id. ¶ 85.) Some contraindications
include: (1) whether an inmate will remain incarcerated long enough to complete treatment;
(2) whether an inmate has infractions related to alcohol or drug use within twelve months of
treatment; (3) whether an inmate’s life expectancy is less than ten years; and (4) whether an
inmate has unstable medical or mental health conditions. (Id. ¶¶ 87, 89, 91-92.) Plaintiffs
assert that most of the contraindications are holdovers from the previous HCV treatment, are
cost-saving measures for Defendants, and are unjustifiable. (Id. ¶¶ 86, 88, 90-92; see also Muir
Am. Aff. ¶¶ 31-37.)
Once a prisoner has been diagnosed with HCV, Policy #CP-7 also requires follow-up
testing every six months and a complete blood count must be performed annually. (Compl.
¶ 93.) As Caldwell had not undergone any follow-up testing from 2015 up to the filing of the
Complaint, Plaintiffs argue that there is no guarantee that such testing will be done. (Id.)
As a result of DPS’s current screening and treatment policies regarding HCV, Plaintiffs
have alleged an Eighth Amendment claim pursuant to 42 U.S.C. § 1983 and a claim under the
6
Americans with Disabilities Act (“ADA”), 42 U.S.C. § 12131, et seq. (Compl. ¶¶ 110-117.) In
conjunction with the Complaint, the named Plaintiffs also filed a motion to certify class.
(Docket Entry 3.) Plaintiffs seek to certify a class defined as “all current and future prisoners
in DPS custody who have or will have chronic hepatitis C virus, at least twelve weeks
remaining on their sentences, and have not [received DAAs].” (Id. at 1; Compl. ¶ 105.)
Additionally, Plaintiffs ask the Court to issue a preliminary injunction ordering Defendants to:
(1) provide universal opt-out HCV screening for all persons who are or will be in DPS custody;
(2) cease denying DAA treatment for the contraindications listed in Policy #CP-7 (other than
patient refusal); and (3) treat Plaintiffs and all members of their class with DAAs according to
the current standard of medical care set out in the AASLD/IDSA Guidance, regardless of an
individual’s fibrosis level. (Docket Entry 26.) Defendants have opposed both motions.
(Docket Entries 31, 32.)
II.
DISCUSSION
A. Plaintiffs’ Motion to Certify Class
The named Plaintiffs seek to certify a class defined as “all current and future prisoners
in DPS custody who have or will have chronic hepatitis C virus, at least twelve weeks
remaining on their sentences, and have not [received DAA treatment].” (Id. at 1; Compl.
¶ 105.) The named Plaintiffs move pursuant to Federal Rule of Civil Procedure 23 and Local
Rule 23.1(b).4 Federal Rule of Civil Procedure 23 sets forth a two-step analysis that governs
4
Pursuant to Local Rule 23.1, in ruling upon whether a matter may be maintained as a class action,
“the Court may allow the action to be so maintained, may disallow and strike the class action
allegations, or may order postponement of the determination pending discovery or such other
preliminary procedures as appear to be appropriate and necessary in the circumstances.” M.D.N.C.
LR 23.1(b). “The burden shall be upon any party seeking to maintain a case as a class action to present
7
the standard for class certification. Fed. R. Civ. P. 23. First, the prerequisites (commonly
referred to as numerosity, commonality, typicality, and adequacy) require that “[o]ne or more
members of a class may sue or be sued as representative parties on behalf of all members only
if:”
(1) the class is so numerous that joinder of all members is
impracticable;
(2) there are questions of law or fact common to the class;
(3) the claims or defenses of the representative parties are typical
of the claims or defenses of the class; and
(4) the representative parties will fairly and adequately protect the
interests of the class.
Fed. R. Civ. P. 23(a)(1)-(4). The Fourth Circuit Court of Appeals has reiterated that
the final three requirements of Rule 23(a) tend to merge, with
commonality and typicality serving as guideposts for determining
whether . . . maintenance of a class action is economical and
whether the named plaintiff’s claim and the class claims are so
interrelated that the interests of the class members will be fairly
and adequately protected in their absence.
Brown v. Nucor Corp., 576 F.3d 149, 152 (4th Cir. 2009) (internal quotations and citations
omitted).
In addition, the Fourth Circuit has “repeatedly recognized that Rule 23 contains an
implicit threshold requirement that the members of a proposed class be ‘readily identifiable’”
or ascertainable such that the “court can readily identify the class members in reference to
objective criteria.” EQT Prod. Co. v. Adair, 764 F.3d 347, 358 (4th Cir. 2014) (citation omitted).
an evidentiary basis to the Court showing that the action is properly maintainable as such.” M.D.N.C.
LR 23.1(d).
8
The moving party “need not be able to identify every class member at the time of
certification.” Id. However, “[i]f class members are impossible to identify without extensive
and individualized fact-finding or mini-trials, then a class action is inappropriate.” Id. (internal
quotations and citations omitted).
Upon satisfying Rule 23(a), the moving party must demonstrate that the action falls
under one of the three types of class listed in Rule 23(b). Here, Plaintiffs assert that Rule
23(b)(2) is applicable which states that a class action may be maintained if “the party opposing
the class has acted or refused to act on grounds that apply generally to the class, so that final
injunctive relief or corresponding declaratory relief is appropriate respecting the class as a
whole[.]” Fed. R. Civ. P. 23(b)(2). Simply put, Rule 23(b)(2) applies “only when a single
injunction or declaratory judgment would provide relief to each member of the class.” WalMart Stores, Inc. v. Dukes, 564 U.S. 338, 360 (2011). Plaintiffs bear the burden of demonstrating
that the class complies with Rule 23. Thorn v. Jefferson-Pilot Life Ins. Co., 445 F.3d 311, 321 (4th
Cir. 2006) (citation omitted). District courts have broad discretion in deciding whether to
certify a class. Ward v. Dixie Nat. Life Ins. Co., 595 F.3d 164, 179 (4th Cir. 2010).
1. Ascertainability of the Proposed Class
Defendants first argue that the class as defined is not ascertainable because it includes
both current and future DPS inmates “without any time limit” and it requires knowledge of
all prisoners who have HCV or will have HCV in the future. (Docket Entry 31 at 6-8.)
Defendants’ argument is unpersuasive. As previously stated, every class member need not be
identified at the time of certification. The fact that the DPS prison population changes daily
does not prevent the certification of the proposed class. Indeed, several courts have routinely
9
permitted prisoner class actions challenging healthcare policies. See Scott v. Clarke, 61 F. Supp.
3d 569, 583 (W.D. Va. 2014) (collecting cases). The key here is the “indivisible nature of the
injunctive or declaratory remedy warranted” such that “each individual class member would
[not] be entitled to a different injunction or declaratory judgement against the defendant.” WalMart Stores, 564 U.S. at 360 (emphasis in original). All prisoners, as defined in the proposed
class, would have access to HCV screening and appropriate follow-up treatment.
Even more notable here is the Court’s consideration of ascertainability within the
context of a Rule 23(b)(2) class action. As previously stated, the Fourth Circuit acknowledges
the “implicit threshold requirement of ascertainability.” See Adair, 764 F.3d at 358. However,
it has not addressed this issue directly in the context of a Rule 23(b)(2) class action. Several
other circuits have addressed this issue and have applied the requirement of ascertainability
less stringently in Rule 23(b)(2) cases. See Cole v. City of Memphis, 839 F.3d 530, 542 (6th Cir.
2016), cert. denied, 137 S. Ct. 2220 (2017) (“The advisory committee’s notes for Rule 23(b)(2)
assure us that ascertainability is inappropriate in the (b)(2) context.”); Shelton v. Bledsoe, 775 F.3d
554, 562 (3d Cir. 2015) (“The ascertainability requirement ensures that the procedural
safeguards necessary for litigation as a (b)(3) class are met, but it need not (and should not)
perform the same function in (b)(2) litigation.”); Shook v. El Paso Cty., 386 F.3d 963, 972 (10th
Cir. 2004) (“[M]any courts have found Rule 23(b)(2) well suited for cases where the
composition of a class is not readily ascertainable; for instance, in a case where the plaintiffs
attempt to bring suit on behalf of a shifting prison population.”); Yaffe v. Powers, 454 F.2d 1362,
1366 (1st Cir. 1972) (citation omitted) (“[T]he conduct complained of is the benchmark for
determining whether a subdivision (b)(2) class exists, making it uniquely suited to civil rights
10
actions in which the members of the class are often ‘incapable of specific enumeration’.”). But
see Adashunas v. Negley, 626 F.2d 600, 603-04 (7th Cir. 1980) (declining certification of a
proposed class of “children entitled to a public education who have learning disabilities and
‘who are not properly identified and/or who are not receiving’ special education” because of
definiteness concerns); DeBremaecker v. Short, 433 F.2d 733, 734 (5th Cir. 1970) (internal
quotation omitted) (“A class made up of residents of [Texas] active in the peace movement
does not constitute an adequately defined or clearly ascertainable class contemplated by Rule
23.”).
At the hearing, Defendants took specific issue with a portion of the proposed class
definition, specifically the portion of the class definition that states that prisoners have at least
twelve weeks remaining on their sentences.5 Defense counsel stated that removing this
portion would provide more certainty to the issues here. Given all the considerations above,
the Court concludes that the proposed class, modified to exclude the twelve week sentence
window, is ascertainable.6
2. Numerosity
The numerosity requirement provides that the proposed class be “so numerous that
joinder of all members is impracticable.” Fed. R. Civ. P. 23(a)(1). Defendants do not oppose
this issue. DPS has identified 1,543 persons in custody who have been diagnosed with chronic
HCV; Defendant Smith stated that the DPS prisoner population is approximately 37,000, and
5
The hearings in this matter were recorded. The Court has not ordered a certified transcript at this
time.
6
Defendants made additional arguments related to ascertainability in the opposition brief. (See Docket
Entry 31 at 7-8.) Again, given the representations made at the hearing, the Court finds it unnecessary
to further address this issue.
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the number of prisoners with HCV could be between 6,559 and 12,553. (See Ex. E, Docket
Entry 3-5 at 3; Dr. Paula Smith Aff. ¶¶ 9-11, Docket Entry 3-4.) Given such estimates, joinder
of all DPS prisoners would certainly be impracticable. Scott, 61 F. Supp. 3d at 584 (citation
omitted) (“In general, if a proposed class size exceeds 25 plaintiffs, joinder is usually presumed
impracticable.”); see also Dean v. Coughlin, 107 F.R.D. 331, 332-33 (S.D.N.Y. 1985) (“The fluid
composition of a prison population is particularly well-suited for class status, because,
although the identity of the individuals involved may change, the nature of the wrong and the
basic parameters of the group affected remain constant.”)
3. Commonality
The commonality prerequisite provides that there be “questions of law or fact common
to the class.” Fed. R. Civ. P. 23(a)(2). A single common question is sufficient. Wal-Mart
Stores, 564 U.S. at 359 (citation omitted). Here Plaintiffs allege the same injuries that the
proposed class are suffering in that Defendants maintain a policy that fails to provide them
with adequate medical treatment for chronic HCV which constitutes deliberate indifference
to a serious medical need, and amounts to discrimination on the bases of their disability.
Defendants do not dispute that this requirement is met. The undersigned also agrees. See
Postawko v. Missouri Dep’t of Corr., No. 2:16-CV-04219-NKL, 2017 WL 3185155, at *7 (W.D.
Mo. July 26, 2017) (unpublished) (“The Court is satisfied that the commonality requirement is
met because the alleged HCV-treatment policies or customs are the ‘glue’ that holds together
the putative class; either these policies are unlawful as to all inmates or they are not.”).
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4. Typicality
To satisfy the typicality requirement, “the claims or defenses of the representative
parties [must be] typical of the claims or defenses of the class.” Fed. R. Civ. P. 23(a)(3).
“Claims are typical of each other if they arise from the same event or pattern or practice and
are based on the same legal theory.” Hoffer v. Jones, 323 F.R.D. 694, 698 (N.D. Fla. 2017)
(“Hoffer I”) (internal quotations and citation omitted). Here, both Plaintiffs’ claims and the
class claims are rooted in deliberate indifference under the Eighth Amendment and
discrimination under the ADA. (Compl. ¶¶ 110-17.) Defendants argue that Plaintiffs cannot
establish that the decision to decline administering DAAs to the class members is based on
the same course of conduct since the decision is based upon an individual risk-based
assessment that considers an inmates medical history and potential contraindications. (Docket
Entry 31 at 8; Dr. Anita Wilson Aff. ¶ 34, Docket Entry 32-1.) This Court disagrees and
concludes that the typicality requirement is met.
The typicality requirement is not defeated simply because the class members may have
some factual differences. Rather, courts that have rejected similar arguments seem to focus
on the fact that all the class members suffer the same constitutional injury as they all are
subjected to a prison policy that creates a substantial risk of harm. See e.g., Stafford v. Carter,
No. 117CV00289JMSMJD, 2018 WL 1140388, at *7 (S.D. Ind. Mar. 2, 2018) (unpublished)
(“Plaintiffs raise claims regarding the policies maintained by [prison] regarding who receives
and does not receive treatment for diagnosed HCV. These claims are not dependent on
individualized assessments.”); Hoffer I, 323 F.R.D. at 699 (“Plaintiffs’ claims are based on the
same legal theories as the class’s claims, and Plaintiffs are not in a markedly different factual
13
position than other class members (at least not in a sense that would be relevant for purposes
of their claims).”); Postawko, 2017 WL 3185155, at *8 (“[T]here may be variance in symptoms,
contraindications for treatment, and differing levels of physical health from inmate to inmate,
but every inmate suffers exactly the same constitutional injury when he is exposed to a single
statewide [prison] policy or practice that creates a substantial risk of serious harm . . . .”).
Plaintiffs’ success in the action would certainly benefit all DPS prisoners alike.
Defendants also argue that no specific set of criteria “governing-or precludingparticularized treatment to HCV-positive inmates” (see Docket Entry 31 at 8) is present, but
Policy #CP-7 is the current governing policy that sets forth HCV treatment protocol.
Plaintiffs’ allegations in the Complaint assert that this policy precludes HCV treatment in the
form of DAAs based upon a set of specific criteria that embody restrictions that are not
medically justified. (Compl. ¶¶ 3-5, 79-104.) Defendants’ argument is therefore unpersuasive.
5. Adequacy of Representation
The adequacy requirement provides that the class be certified only if “the
representative parties will fairly and adequately protect the interests of the class.” Fed. R. Civ.
P. 23(b)(4). This requirement “serves to uncover conflicts of interest between named parties
and the class they seek to represent.” Amchem Prod., Inc. v. Windsor, 521 U.S. 591, 625 (1997).
There does not appear to be any dispute as to the adequacy of the class representatives. Also,
the named Plaintiffs and the proposed class share the same common interests in this litigation.
Thus, the Court concludes that this requirement is met.
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6. Rule 23(b)(2)
Having satisfied the requirements of Rule 23(a), the Court must now decide whether
this action falls within Rule 23(b)(2). As previously discussed, the key to Rule 23(b)(2) is the
indivisible nature of the injunctive relief sought. Wal-Mart Stores, 564 U.S. at 360. “Rule
23(b)(2) has been liberally applied in the area of civil rights, including suits challenging
conditions and practices at various detention facilities, as well as claims for violations of the
ADA and Rehabilitation Act.” Bumgarner v. NCDOC, 276 F.R.D. 452, 457 (E.D.N.C. 2011);
see also Scott, 61 F. Supp. 3d at 591 (collecting cases). As explained by one court, “[t]he essential
consideration is whether the complaint alleges that the plaintiffs have been injured by
defendants’ conduct which is based on policies and practices applicable to the entire class.”
Santiago v. City of Philadelphia, 72 F.R.D. 619, 626 (E.D. Pa. 1976).
Defendants argue that certification under Rule 23(b)(2) is inappropriate because DPS
has not acted or refused to act towards the class in a general manner. (Docket Entry 31 at 9.)
More specifically, Defendants assert that Policy #CP-7 is “not a one-size fits all approach.”
(Id.) Again, this argument is similar to Defendant’s argument challenging typicality, and
likewise unpersuasive. It is the policy itself that Plaintiffs are challenging and because Policy
#CP-7 applies to all members of the class, the requested relief would benefit all members.
Chimenti v. Wetzel, No. CV 15-3333, 2018 WL 2388665, at *9 (E.D. Pa. May 24, 2018)
(unpublished) (“[T]he [prison’s] Hepatitis C Protocol applies to all members of the class and
the requested injunctive relief would provide relief to all class members.”); Graham v. Parker,
No. 16-CV-01954, 2017 WL 1737871, at *6 (M.D. Tenn. May 4, 2017) (unpublished) (rejecting
“Defendants’ argue[ment] that Rule 23(b)(2) does not apply in th[e] case because each
15
individual class member would be entitled to different declaratory or injunctive relief to redress
individual injuries”) (emphasis in original). Thus, Defendants’ argument fails.
7. Standing to Challenge HCV Screening
Lastly, Defendants argue that the named Plaintiffs lack standing to challenge DPS’s
HCV screening protocol and thus cannot represent the class on these issues. (Docket Entry
31 at 9-11.) To establish constitutional standing, “(1) the plaintiff is required to have sustained
an injury in fact; which (2) must be causally connected to the complained-of conduct
undertaken by the defendant; and (3) will likely be redressed if the plaintiff prevails.”
Libertarian Party of Virginia v. Judd, 718 F.3d 308, 313 (4th Cir. 2013). In the case of class
actions, “named plaintiffs who represent a class must allege and show that they personally
have been injured, not that injury has been suffered by other, unidentified members of the
class to which they belong and which they purport to represent.” Simon v. E. Ky. Welfare Rights
Org., 426 U.S. 26, 40 n.20 (1976) (internal quotations and citation omitted); accord Doe v. Obama,
631 F.3d 157, 160 (4th Cir. 2011). In other words, “[t]here must be a named plaintiff with
constitutional standing to assert each claim.” Clark v. Duke Univ., No. 1:16-CV-1044, 2018
WL 1801946, at *2 (M.D.N.C. Apr. 13, 2018) (unpublished).
Here, Defendants contend that each of the named Plaintiffs have been diagnosed with
HCV, therefore they no longer require screening. (Docket Entry 31 at 10.) Parham was
diagnosed prior to his incarceration and both Caldwell and Buffkin were diagnosed while in
prison. (Compl. ¶¶ 53, 63, 74.) Thus, it is Defendants’ position that implementing universal
opt-out HCV screening will provide no relief to the named Plaintiffs and would “not even
affect them.” (Docket Entry 31 at 11.) Defendants’ argument, however, is flawed. Policy
16
#CP-7 governs the management of HCV as a whole, in which all Plaintiffs are subject to as a
result of their state of incarceration. Defendants argued at the hearing that the named
Plaintiffs have divided out particular portions of Policy #CP-7 in their Complaint and
motions, and thus, should not be able to argue that a broad application of Policy #CP-7 is
warranted. Even if Caldwell and Buffkin were effectively screened and diagnosed as a result
of the current Policy #CP-7, there is significant risk of reinfection by virtue of the prison
environment and the discretion given to prison medical officials to conduct the initial
screening. Indeed, even Defendants themselves admit that HCV is a public health concern
and that the jail population has a higher concentration of HCV-infected persons than the
general population. (Ans. ¶¶ 47-50, Docket Entry 25.) Thus, reinfection by the named
Plaintiffs is a realistic danger, particularly with regard to prisoners such as Parham who is
serving a life sentence. (Compl. ¶ 62.) See also Peterson v. Nat’l Telecommunications & Info. Admin.,
478 F.3d 626, 632 (4th Cir. 2007) (finding that in order to have standing, “[t]he plaintiff must
demonstrate a realistic danger of sustaining a direct injury as a result of government action”
(internal citations and quotations omitted)). As stated by another district court, “simply
because an inmate does not use medical care, receives adequate care once, or does not or get
attacked does not mean they are not at an unreasonable risk when policies and practices are
deficient.” Hernandez v. Cty. of Monterey, 305 F.R.D. 132, 149 (N.D. Cal. 2015); see also Lippert v.
Baldwin, No. 10 C 4603, 2017 WL 1545672, at *2 (N.D. Ill. Apr. 28, 2017) (quoting Helling v.
McKinney, 509 U.S. 25, 33 (1993) (rejecting Defendants’ standing argument “because the
Supreme Court has held that ‘the Eighth Amendment protects against future harms to
inmates’ and a ‘remedy for unsafe conditions need not await a tragic event.’”)).
17
Moreover, as Plaintiffs contend, Defendants’ argument creates a catch-22 quandary in
that a prisoner would have to know of his or her HCV diagnosis to have standing to challenge
Policy #CP-7, but that same knowledge would preclude a challenge to the HCV screening
protocol.7 Defendants’ position creates a situation where the screening provision within
Policy #CP-7 could never be challenged.
In sum, the undersigned concludes that the named Plaintiffs have standing to challenge
Policy #CP-7, including its HCV screening provision. Given the HCV contagion in the prison
context, the threat of future harm is imminent and a direct result of Policy #CP-7. The relief
the named Plaintiffs seek―universal opt-out screening―will provide them relief as well as the
proposed class members.8 See Hoffer v. Jones, 290 F. Supp. 3d 1292, 1305 (N.D. Fla. 2017)
(“Hoffer II”) (ordering a revised plan for HCV care to include “screening, evaluating . . .” even
though plaintiffs had been already diagnosed at the time the civil action commenced); Brooks
v. Ward, 97 F.R.D. 529, 533 (W.D.N.C. 1983) (permitting a class action where intervenor “and
the class seek injunctive and declaratory relief for [a totality of] conditions of confinement
[including screening policies] which affect all prisoners generally”).
7
Another district court, outside of the prison context, found that a catch-22 scenario would create
“an impossible burden” precluding “injunctive relief altogether.” In re Yahoo Mail Litig., 308 F.R.D.
577, 589 (N.D. Cal. 2015).
8
The undersigned further notes that it is unclear from Policy #CP-7 what exactly constitutes HCV
screening. The policy at Step 1 discusses appropriate screening for HCV. (Policy #CP-7, Docket
Entry 27-2 at 4.) However, Step 2 provides for “initial medical follow-up anti-HCV positive inmates”
which include baseline lab testing. (Id. at 4-5.) Thus, it is not entirely clear where DPS draws the line
on its HCV screening process and moves into treatment.
18
8. Appointment of Class Counsel
Rule 23(g) provides the considerations for appointment of class counsel in a class
action. Fed. R. Civ. P. 23(g). Considerations include previous work regarding claims in the
pending action, counsel’s knowledge of the law and experience in class actions suits, and
resources that counsel will commit to representing the class. Fed. R. Civ. P. 23(g)(1).
Defendants do not dispute the qualifications of Plaintiffs’ counsel. In addition, Plaintiffs assert
that their attorneys have “specialized expertise in constitutional and civil rights litigation [and
prisoner’s rights] in federal court” and they have not identified any conflicts of interest in
representing the proposed class. (Docket Entry 4 at 16; Michele Luecking-Sunman Decl.
¶¶ 1-4, Docket Entry 3-6; Christopher A. Brook Decl. ¶¶ 1-5, Docket Entry 3-7.) The Court
thus concludes that Plaintiffs’ counsel have satisfied Rule 23(g).9
B. Plaintiffs’ Motion for Preliminary Injunction
Plaintiffs also move for a preliminary injunction ordering Defendants to: (1) provide
universal opt-out HCV screening for all persons who are or will be in DPS custody; (2) cease
denying DAA treatment for the contraindications listed in Policy #CP-7 (other than patient
refusal); and (3) treat Plaintiffs and all members of their class with DAAs according to the
current standard of medical care set out in the AASLD/IDSA Guidance, regardless of an
individual’s fibrosis level. (Docket Entry 26.) A party seeking a preliminary injunction must
establish all four of the following elements: (1) he is likely to succeed on the merits; (2) he is
likely to suffer irreparable harm in the absence of preliminary relief; (3) the balance of equities
tips in his favor; and (4) an injunction is in the public interest. Winter v. Natural Resources Defense
9
To the extent necessary, representations of Plaintiffs’ counsel also satisfy Rule 23(a)(4).
19
Council, Inc., 555 U.S. 7, 20 (2008); see also The Real Truth About Obama, Inc. v. Fed. Election Comm’n,
575 F.3d 342, 346-47 (4th Cir. 2009), overruling Blackwelder Furniture Co. of Statesville v. Seilig Mfg.
Co., 550 F.2d 189 (4th Cir. 1977).10 A party must make a clear showing that he is likely to
succeed on the merits of his claim. Winter, 555 U.S. at 20; Real Truth, 575 F.3d at 345-46.
Similarly, there must be a clear showing that the party is likely to be irreparably harmed absent
injunctive relief. Winter, 555 U.S. at 20-22; Real Truth, 575 F.3d at 347. Only then does the
court consider whether the balance of equities tips in the favor of the party seeking the
injunction. See Real Truth, 575 F.3d at 346-47. Finally, the court must pay particular regard
to the impact of the extraordinary relief of an injunction upon the public interest. Real Truth,
575 F.3d at 347 (quoting Winter, 555 U.S. at 23-24). Injunctive relief, such as the issuance of
a preliminary injunction, is an extraordinary remedy that may be awarded only upon a clear
showing that the plaintiff is entitled to such relief. Mazurek v. Armstrong, 520 U.S. 968, 972
(1997); see also MicroStrategy Inc. v. Motorola, Inc., 245 F.3d 335, 339 (4th Cir. 2001) (a preliminary
injunction is an “extraordinary remed[y] involving the exercise of very far-reaching power to
be granted only sparingly and in limited circumstances” (citation and quotation omitted)).
“Mandatory preliminary injunctions are granted even more rarely than prohibitory
preliminary injunctions.” Wheelihan v. Bingham, 345 F. Supp. 2d 550, 553 (M.D.N.C. 2004).
Moreover, in granting injunctive relief in the prison context, the relief “must be narrowly
10
The original decision in Real Truth was vacated by the Supreme Court for further consideration in
light of Citizens United v. Fed. Election Comm’n, 558 U.S. 310 (2010). However, the Fourth Circuit
reissued its opinion on Parts I and II of its earlier opinion in the case, 575 F.3d at 345-47, stating the
facts and articulating the standard for issuance of a preliminary injunction, before remanding it to the
district court for consideration in light of Citizens United. See The Real Truth About Obama, Inc. v. Fed.
Election Comm’n, 607 F.3d 355 (4th Cir. 2010).
20
drawn, extend no further than necessary to correct the harm the court finds requires
preliminary relief, and be the least intrusive means necessary to correct that harm.” 18 U.S.C.
§ 3626(a)(2). Additionally, “[t]he court shall give substantial weight to any adverse impact on
public safety or the operation of a criminal justice system caused by the preliminary relief
. . . .” Id.
1. Standing for Challenges to HCV Screening and Contraindications
Prior to addressing the factors for injunctive relief, Defendants argue that Plaintiffs
lack standing to challenge HCV screening in the prison, and lack standing to challenge the
contraindications within Policy #CP-7 as neither of the named Plaintiffs have been denied
DAA treatment as a result of the contraindications. (Docket Entry 32 at 5-7.) The Court has
previously discussed, and found unpersuasive, Defendants’ argument regarding lack of HCV
screening. The contraindications have the same affect. Again, the challenge here is to systemic
failures to provide adequate HCV care within prisons in the control of DPS. Policy #CP-7
applies to all prisoners, and as such, all prisoners, including the named Plaintiffs are subject to
the policy in its entirety, including the contraindications. Defendants’ argument thus fails.
2. Likelihood of Success on the Merits
Deliberate Indifference
In Farmer v. Brennan, 511 U.S. 825 (1994), the Supreme Court held that the Eighth
Amendment to the Constitution “imposes duties on [prison] officials who must provide
humane conditions of confinement; prison officials must ensure that inmates receive adequate
food, clothing, shelter, and medical care, and must take reasonable measures to guarantee the
safety of the inmates.” Id. at 832 (internal quotation and citation omitted). A successful Eighth
21
Amendment claim contains two elements: the deprivation must be, objectively, “sufficiently
serious,” and the prison official must have demonstrated a “deliberate indifference to inmate
health or safety.” Id. at 834.
“Deliberate indifference is a very high standard–a showing of mere negligence will not
meet it.”
Grayson v. Peed, 195 F.3d 692, 695 (4th Cir. 1999).
Rather, the “deliberate
indifference” prong requires Plaintiff to make “two showings:”
First, the evidence must show that the official in question subjectively
recognized a substantial risk of harm. It is not enough that the officers should
have recognized it; they actually must have perceived the risk. Second, the
evidence must show that the official in question subjectively recognized that his
actions were inappropriate in light of that risk. As with the subjective awareness
element, it is not enough that the official should have recognized that his action
were inappropriate; the official actually must have recognized that his actions
were insufficient.
Parrish ex rel. Lee v. Cleveland, 372 F.3d 294, 303 (4th Cir. 2004) (internal citations and quotation
marks omitted) (emphasis in original). “The subjective component therefore sets a particularly
high bar to recovery.” Iko v. Shreve, 535 F.3d 225, 241 (4th Cir. 2008). “‘Deliberate indifference
entails something more than mere negligence. . . .’” Shakka v. Smith, 71 F.3d 162, 166 (4th Cir.
1995) (quoting Farmer 511 U.S. at 835). “It requires that a prison official know of and disregard
the objectively serious condition, medical need, or risk of harm.” Id. To constitute deliberate
indifference, “the treatment must be so grossly incompetent, inadequate, or excessive as to
shock the conscience or to be intolerable to fundamental fairness.” Miltier v. Beorn, 896 F.2d
848, 851 (4th Cir. 1990).11
Thus, a plaintiff may prove deliberate indifference by
demonstrating that prisons officials have been “intentionally denying or delaying medical
Miltier has been overruled by Farmer to the extent that it allowed a finding of deliberate indifference
upon constructive knowledge, but it is still good law for the proposition cited.
11
22
access to medical care,” Estelle v. Gamble, 429 U.S. 97 (1976), or by demonstrating that a
substantial risk of harm was “longstanding, pervasive, well-documented, or expressly noted by
prison officials in the past, and the circumstances suggest that the defendant-official . . . had
been exposed to information concerning the risk and thus must have known about it.” Scinto
v. Stansberry, 841 F.3d 219, 226 (4th Cir. 2016) (internal quotations and citation omitted). Also,
“[a] delay in treatment may constitute deliberate indifference if the delay exacerbated the injury
or unnecessarily prolonged an inmate’s pain.” Sharpe v. S.C. Dep’t of Corr., 621 F. App’x 732,
734 (4th Cir. 2015) (unpublished) (internal quotations and citation omitted).
However, it is clear that “mere negligence or malpractice” does not constitute
deliberate indifference. Miltier, 896 F.2d at 852. Similarly, “[d]isagreements between an inmate
and a physician over the inmate’s proper medical care do not state a § 1983 claim unless
exceptional circumstances are alleged.” Wright v. Collins, 766 F.2d 841, 849 (4th Cir. 1985). It
is well settled, therefore, that a medical need serious enough to give rise to a constitutional
claim involves a condition that places the inmate at a substantial risk of serious harm, usually
loss of life or permanent disability, or a condition for which lack of treatment perpetuates
severe pain. Farmer, 511 U.S. at 832-35.
Defendants do not dispute that chronic HCV is a serious medical need. Indeed, several
courts have acknowledged that fact. See Hoffer II, 290 F. Supp. 3d at 1299 (“[I]t [should not]
be surprising that [the] Court finds chronic HCV to be a serious medical need.”); Abu-Jamal v.
Wetzel, No. 3:16-CV-2000, 2017 WL 34700, at *14 (M.D. Pa. Jan. 3, 2017) (unpublished)
(finding that “Plaintiffs has a reasonable likelihood of showing that chronic hepatitis C
constitutes a serious medical need under the Eighth Amendment”); Loeber v. Andem, 487 F.
23
App’x 548, 549 (11th Cir. 2012) (unpublished) (“That Hepatitis C presents a serious medical
need is undisputed.”); Bender v. Regier, 385 F.3d 1133, 1137 (8th Cir. 2004) (“HCV infection is
unquestionably a serious medical problem.”); Campbell v. Young, No. CIV. A. 700CV00046,
2001 WL 418725, at *3 (W.D. Va. Mar. 22, 2001) (unpublished) (“[T]here is no question that
[plaintiff] suffers from a serious medical condition, namely, Hepatitis C and the associated
pain and symptoms[.]”). If not treated, Plaintiffs are subject to substantial risks of harm,
including significant liver scarring (cirrhosis) and exposed to high risks of cancer, extremely
painful complications, and death. (Muir Am. Aff. ¶¶ 11, 12, 38.)
The question thus becomes whether Defendants have acted with deliberate
indifference by consciously disregarding the known risks of Plaintiffs’ serious medical needs.
The Court concludes that there is a substantial likelihood that Plaintiffs will be successful on
this issue.12 Defendants are certainly aware of the prevalence of HCV in North Carolina’s
prisons. In another HCV action, Defendant Smith concluded that approximately 12,553 DPS
inmates are infected with HCV based upon review of the CDC’s estimation that 33% of all
incarcerated persons have HCV. (Smith Aff. ¶ 11.) By its current implementation, Policy
#CP-7 in its entirety allows Defendants to act with deliberate indifference with regards to
adequate detection and treatment of HCV to inmates in DPS’s custody. Defendants argue
that the risk-based screening approach is an “evidence-based policy that incorporates concepts
12
Having concluded that Plaintiffs have established a likelihood of success on the merits of their
Eighth Amendment deliberate indifference claim, the Court need not address their claim under the
ADA. See League of Women Voters of N. Carolina v. North Carolina, 769 F.3d 224, 248 (4th Cir. 2014)
(“[B]ecause we find that Plaintiffs are likely to succeed on the merits under the Voting Rights Act, we
need not, and therefore do not, reach the constitutional [claims].”).
24
from the AASLD/IDSA Guidance, the Federal Guidelines [“BOP Guidance”], or both.”
(Docket Entry 32 at 12.) More particularly, Defendants state that “[b]ecause HCV may be
asymptomatic, progresses slowly, and does so at rates that will vary from patient to patient,
there is no evidence” suggesting that the proposed class is subject to excessive risk of harm.
(Id.) This argument is flawed.
Appropriate and adequate screening is germane to the successful assessment and
treatment of any significant health concern. Cody v. Hillard, 599 F. Supp. 1025, 1059 (D.S.D.
1984) (“In general, proper medical screening of inmates is a vital element of adequate medical
services.” (internal quotations and citation omitted)). That HCV may be asymptomatic is
irrelevant here, particularly considering the numerical data regarding HCV in prisons. As
previously noted, the estimations by Dr. Muir suggests that 16-41% of incarcerated persons
in North America are positive for antibodies against HCV. (Muir Am. Aff. ¶ 16.) Thus, he
asserts that screening for all persons who were ever incarcerated is appropriate as
recommended by the AASLD/IDSA Guidance. (Id.) Indeed, the AASLD/IDSA Guidance
acknowledges CDC’s prior recommendation of general risk-based HCV testing13 in 1998, but
those guidelines expanded, partially due to “evidence demonstrating that a risk-based strategy
alone failed to identify more than 50% of HCV infections[.]” (AASLD/IDSA Guidance,
Docket Entry 27-5 at 4.) Considering that incarcerated populations have higher rates of HCV
than the general population, Dr. Muir concluded that HCV screening in prisons (for all
prisoners) would diagnose between 42,000 - 91,000 new HCV cases in the next 30 years; thus,
“[b]y focusing on [the prison] population with high prevalence of HCV infection and curing
13
This does not appear to be limited to the prison context.
25
them prior to release, there is less opportunity for them to spread HCV infection to others in
the society.” (Muir Aff. ¶ 16.) The key, however, is effective HCV screening, and the current
risk-based screening approach implemented by DPS “is destined to fail.” (Id. ¶ 17.)14
Defendants argue that the AASLD/IDSA Guidance does not create a standard of care
for treatment for HCV. (Docket Entry 32 at 2; Wilson Aff. ¶ 16.) Defendants further contend
that only 16% of prison facilities nationwide test all inmate for HCV upon entry, and similarly,
only 17 states reported offering routine opt-out HCV testing in prison facilities. (Docket
Entry 32 at 4; Ex. B to Wilson Aff., pp. 210-11, Docket Entry 32-3.) There can be no dispute
that these numbers do not demonstrate that opt-out screening occurs in most of prisons across
the states. Nevertheless, assuming arguendo that the AASLD/IDSA Guidance does not
provide the standard of care HCV treatment, the Court must still ultimately determine whether
DPS’s HCV screening protocol provides prisoners with constitutionally adequate treatment.
That the majority of prison facilities nationwide do not adhere to routine opt-out HCV testing
does not mean that DPS’s HCV screening protocol is constitutionally adequate. See De’lonta
v. Johnson, 708 F.3d 520, 526 (4th Cir. 2013) (emphasis in original) (holding, at the screening
stage, that “just because [prison officials] have provided [prisoner] with some treatment
consistent with the GID Standards of Care, it does not follow that they have necessarily
provided her with constitutionally adequate treatment.”).
The parties also dispute whether Defendants’ prioritization of treatment and the use
of contraindications constitutes deliberate indifference. The undersigned also concludes that
14
As Plaintiffs point out, state law mandates HIV screening for all inmates. See N.C. Gen. Stat. § 14819.2.
26
it is likely that Plaintiffs will succeed on the merits as to these points. In support of
Defendants’ position, Dr. Wilson points to the AASLD/IDSA Guidance that expressly
recognizes the need to prioritize in certain contexts. (Wilson Aff. ¶ 27.) The Court is also
mindful of the BOP Guidance which expresses the appropriateness of prioritization in certain
circumstances within the medical context, including HCV treatment. (Ex. C to Wilson Aff.,
Docket Entry 32-5 at 12-13.) But as Plaintiffs argue, Policy #CP-7 does not create a priority
list, but rather determines who will or will not receive treatment at all. An inmate that has a
fibrosis level below F2 is ineligible for DAAs. Thus, they are not waiting for treatment.
Instead, even with a HCV diagnosis, they must continue suffering until their condition
worsens, nearly to the point of significant liver damage, before there is a possibility of
treatment through DAAs. Dr. Muir noted that effective treatment of HCV involves treating
patients well before the presence of cirrhosis.15 (Muir Am. Aff. ¶ 38.)
Moreover, the Court cannot ignore the noted lack of consistent accuracy with the
FibroSure testing mechanisms.16 (See Muir Am. Aff. ¶ 27 (noting that the test characteristics
are modest with sensitivity for detecting significant fibrosis reported at 60-75% with specificity
80-90%); see also Chimenti, 2018 WL 3388305, at *12 (finding that the prison system’s “reliance
on an inaccurate method of testing for fibrosis could result in the [prison system] failing to
15
The court in Stafford held that “delaying treatment for chronic HCV until patients have developed
more advanced stage liver fibrosis has been demonstrated to result in two to five times higher rates of
liver-related mortality, as compared to those offered treatment at an earlier stage.” 2018 WL 4361639,
at *17 (citation omitted).
16
Dr. Muir also acknowledges that in the last two years, several commercial payers and NC Medicaid
stopped requiring a fibrosis score of F2 and are now treating all patients. (Muir Am. Aff. ¶ 39.) Also,
Medicare and the Veterans Affairs medical centers do not restrict DAA therapy according to fibrosis.
(Id.)
27
treat many individuals who suffer from advanced fibrosis and cirrhosis.”)). Here, Plaintiff
Parham never registered a FibroSure score higher than F2, but his medical records indicate a
history of cirrhosis, something commonly associated with a FibroSure score of F4. (Muir Am.
Aff. ¶¶ 40-41; Attach. 2 to Muir Am. Aff., Docket Entry 27-1 at 57-59.) Although some
individuals may be asymptomatic, those with a FibroSure test score below F2 may still
experience very painful symptoms. (Muir Am. Aff. ¶¶ 42-43.)
As to the four contraindications which Plaintiffs challenge, Defendants only argue that
two particular contraindications―recent alcohol or drug infractions and unstable medical or
mental health conditions―are similarly valued in the AASLD/IDSA Guidance and the BOP
Guidelines. (Docket Entry 32 at 14.) Notwithstanding such, Dr. Muir indicates that they
appear to be a holdover from the days of treatment with interferon-based regimens and they
have no medical justifications. (See Muir Am. Aff. ¶¶ 35, 37.) This Court agrees. Additionally,
the requirement that an inmate have at least 12 months left on a sentence is not medically
based (see id. ¶ 33), nor is it consistent with DAA treatment that typically requires only 8-12
weeks. Treatment is also contraindicated if an inmate’s life expectancy is estimated to be less
than 10 years due to co-morbid conditions. However, within that period of time, as Dr. Muir
notes, “a patient could progress from compensated liver disease to decompensated cirrhosis
and die from the awful complication of portal hypertension or liver cancer.” (Id. ¶ 34.)
Overall, the detection, evaluation and treatment of HCV in DPS’s prisons must not
violate the Eighth Amendment. Here, whether its inadequate care, or a refusal to provide
essential care to inmates, the undersigned finds that it likely that Plaintiffs will prevail on the
merits of their claim by demonstrating that Policy #CP-7 exceeds the bounds of their Eighth
28
Amendment right to be free from cruel and unusual punishment. Torraco v. Maloney, 923 F.2d
231, 234 (1st Cir. 1991) (“[D]eliberate indifference may be found where the attention received
is so clearly inadequate as to amount to a refusal to provide essential care.” (internal quotations
and citation omitted)); Smith v. Jenkins, 919 F.2d 90, 93 (8th Cir. 1990) (“Grossly incompetent
or inadequate care can constitute deliberate indifference.” (citation omitted)).
3. The Extent to Which the Moving Party Will Suffer Irreparable Harm Without
Injunctive Relief.
The Court must also consider the extent in which the moving party will suffer
irreparable harm if injunctive relief is not granted. “[S]imply showing some possibility of
irreparable injury fails to satisfy [this] factor.” Nken v. Holder, 556 U.S. 418, 435 (2009) (internal
quotations and citation omitted). Here, Parham and Buffkin will continue to suffer from
chronic HCV if they do not receive treatment. As stated in Abu-Jamal, “the efficacy of the
DAA medications will likely be reduced if treatment is delayed.” 2017 WL 34700, at *20. Both
Parham and Buffkin have already suffered significant scarring and painful symptoms, including
pedal edema and dermatitis. (Muir Am. Aff. ¶¶ 41-43, 49.) Thus, they will likely suffer
irreparable harm absent injunctive relief. See Hoffer II, 290 F. Supp. 3d at 1304 (“Although
DAAs can cure . . . HCV, they do not necessarily reduce the level of fibrosis a person has
already suffered. Consequently, it is important to treat patients with HCV as soon as possible
so that they can be cured of the virus before their liver becomes significantly diseased.”
(internal citations omitted)); see also Abu-Jamal, 2017 WL 34700, at *20 (“The realities of civil
litigation make it likely that waiting for resolution at trial will prolong Plaintiff[s’] suffering for
a significant period of time and result in an overall deterioration of his health.”).
29
4. The Extent to Which the Non-Moving Party Will Suffer Irreparable Harm if the
Injunction is Issued.
In determining whether to grant or deny injunctive relief, the Court must also consider
the extent in which the non-moving party will suffer irreparable harm if the injunction is
issued. In conclusory fashion, Defendants assert that the balance of harm does not tilt in
Plaintiffs’ favor because the relief they request would require “an extensive overhaul of [DPS’s]
health services operations, including review of logistical considerations of travel and housing
assignments for personnel and patients, physical facility capabilities, and human resource
capacities.” (Docket Entry 32 at 17; see also Wilson Aff. ¶ 8.) The Court disagrees. Although
the relief requested will require immediate change, the extent of such overhaul is limited to
Policy #CP-7, which is solely related to the management of HCV. Any administrative or
financial burdens that Defendants may face are outweighed by the constitutional guarantees
under the Eight Amendment regarding adequate health care to inmates. See Hoffer II, 290 F.
Supp. 3d at 1304 (“The threat of harm to the plaintiffs cannot be outweighed by the risk of
financial burden or administrative inconvenience to the defendants.” (internal quotations and
citation omitted)); Abu-Jamal, 2017 WL 34700, at *20 (“While the Court is sensitive to the
realities of budgetary constraints and the difficult decisions prison officials must make, the
economics of providing this medication cannot outweigh the Eighth Amendment’s
constitutional guarantee of adequate medical care.”); Roe v. Elyea, 631 F.3d 843, 863 (7th Cir.
2011) (“Although administrative convenience and cost may be, in appropriate circumstances,
permissible factors for correctional systems to consider in making treatment decisions, the
Constitution is violated when they are considered to the exclusion of reasonable medical
judgment about inmate health.”); Ancata v. Prison Health Servs., Inc., 769 F.2d 700, 705 (11th Cir.
30
1985) (“Lack of funds for facilities cannot justify an unconstitutional lack of competent
medical care and treatment for inmates.”). Accordingly, the balance of harm tips in Plaintiffs’
favor.
5. Whether an Injunction is in the Public Interest.
“[I]f a plaintiff demonstrates both a likelihood of success on the merits and irreparable
injury, it almost always will be the case that the public interest will favor the plaintiff.” AT&T
v. Winback & Conserve Program, Inc., 42 F.3d 1421, 1427 n.8 (3d Cir. 1994). That the injunctive
relief requested may require some overhaul of DPS’s health services (see Docket Entry 32 at
17) is no justification to deny relief. Defendants correctly note the latitude given by the courts
for prison administration, and the Supreme Court has repeatedly stressed the need to provide
wide-ranging deference to prison administrators in matters of prison management. See Beard
v. Banks, 548 U.S. 521, 528 (2006); Overton v. Bazzetta, 539 U.S. 126, 132 (2003) (“We must
accord substantial deference to the professional judgment of prison administrators, who bear
a significant responsibility for defining the legitimate goals of a corrections system and for
determining the most appropriate means to accomplish them.”). However, “the public is
undoubtedly interested in seeing that inmates’ constitutional rights are not violated.” Hoffer II,
290 F. Supp. 3d at 1304. Moreover, as previously stated, Dr. Muir has noted the societal
effects of treating HCV inside the prison. (Muir Am. Aff. ¶ 16.) Essentially, effective
treatment in the prisons provide less opportunity for HCV transmission in society.17 (Id.) This
factor thus, weighs in Plaintiffs’ favor.
17
According to the Bureau of Justice Statistics, “[a]t least 95% of all state prisoners will be released
from prison at some point.” Reentry Trends In The U.S., Bureau of Justice Statistics,
https://www.bjs.gov/content/reentry/reentry.cfm (last visited November 27, 2018).
31
In concluding here that the injunctive relief requested should be granted, the Court is
mindful of the rare circumstances in which mandatory preliminary injunctions are granted.
The current management of HCV within the DPS prompts the necessity for court intervention
to prevent significant harm while this civil action proceeds. Additionally, the Court finds that
the relief requested is narrowly tailored as it focuses solely on revising one health care policy,
Policy #CP-7. In Brown v. Plata, the Supreme Court held:
To incarcerate, society takes from prisoners the means to provide
for their own needs. Prisoners are dependent on the State for
food, clothing, and necessary medical care. A prison’s failure to
provide sustenance for inmates may actually produce physical
torture or a lingering death. Just as a prisoner may starve if not
fed, he or she may suffer or die if not provided adequate medical
care. A prison that deprives prisoners of basic sustenance,
including adequate medical care, is incompatible with the concept
of human dignity and has no place in civilized society.
563 U.S. 493, 510-11 (2011) (internal quotations and citations omitted). Here, the undersigned
finds that an injunction is necessary to ensure that Plaintiffs and all class members receive
adequate medical care in a manner consistent with the tenets recognized in Brown and the
Constitution.
III.
CONCLUSION
For the reasons stated herein, IT IS HEREBY RECOMMENDED that Plaintiff’s
Motion to Certify Class (Docket Entry 3) be GRANTED and the class be defined as “all
current and future prisoners in DPS custody who have or will have chronic hepatitis C virus
and have not been treated with direct-acting antiviral drugs.”
IT IS FURTHER RECOMMENDED that Lloyd Buffkin and Robert Parham be
named as class representatives and that Plaintiffs’ counsel be appointed as class counsel.
32
IT IS FURTHER RECOMMENDED that Plaintiffs’ Motion for Preliminary
Injunction (Docket Entry 26) be GRANTED and a preliminary injunction be issued ordering
Defendants to: (1) provide universal opt-out HCV screening to all persons who are or will be
in DPS custody; (2) cease denying DAA treatment for the contraindications, other than patient
refusal, set out in Step 4a of DPS Policy #CP-7; and (3) treat Plaintiffs and all members of
their class with DAAs according to the current standard of medical care set out in the
AASLD/IDSA Guidance, regardless of an individual’s fibrosis level.
_____________________________
Joe L. Webster
United States Magistrate Judge
November 30, 2018
Durham, North Carolina
33
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