United States District Court, D. Maryland
DONALD R. PEVIA, Plaintiff
WEXFORD HEALTH SOURCE, INC., et al., Defendants DONALD R. PEVIA, Plaintiff
COMMISSIONER OF CORRECTIONS, et al., Defendants
L. Hollander United States District Judge
Memorandum Opinion resolves dispositive motions in two
related civil rights cases filed by Donald Pevia, the
self-represented plaintiff. At the relevant time, he was
incarcerated by the State of Maryland at North Branch
Correctional Institution (“NBCI”). He advised the
Court that on November 3, 2017, he was transferred to
“WCI.” See ECF 12, Case ELH-17-631; ECF
31, Case ELH-16-1950.
ELH-16-1950 (“Pevia I”), Pevia filed suit against
Wexford Health Sources, Inc. (“Wexford”), as well
as Robustianno Barrera, M.D. and Mahboob Ashraf, M.D.
(collectively, the “Medical Defendants”). In case
ELH-17-631 (“Pevia II”), plaintiff filed suit
against Commissioner of Correction Dayena Corcoran, Assistant
Warden Jeffrey Nines, and Sharon Baucom, M.D. (collectively,
the “Correctional Defendants”). In both cases,
plaintiff, who was born in 1981, claims that he was denied
adequate medical care for treatment in regard to his chronic
Hepatitis C virus (“HCV”) infection, because of
the delay in providing him with the prescription of Harvoni.
Therefore, I shall consolidate the cases for review of
Pevia I, the Medical Defendants have moved to dismiss or, in
the alternative, for summary judgment. ECF 18.The motion
is supported by a memorandum of law (ECF 18-3) (collectively,
“Medical Motion”) and exhibits. Plaintiff opposes
the Medical Motion. Id., ECF 23 & 24. The
Medical Defendants have replied (id., ECF 27) and
plaintiff has filed a surreply (ECF 28), which the Medical
Defendants have moved to strike. Id., ECF 29.
Plaintiff opposes the motion to strike. ECF 30.
Pevia II, the Correctional Defendants have moved to dismiss
or, in the alternative, for summary judgment. ECF 10. It is
supported by a memorandum of law (ECF 10-1) (collectively,
“Correctional Motion”) and exhibits. Plaintiff
opposes the Correctional Motion. Id., ECF 11.
hearing is necessary to resolve the motions. See
Local Rule 105.6 (D. Md. 2016). For the reasons that follow,
defendants' motions, construed as motions for summary
judgment, shall be granted.
Pevia I, the court previously summarized plaintiff's
complaint, as follows, ECF 12 at 1-2:
Plaintiff, a State inmate incarcerated at the North Branch
Correctional Institution (“NBCI”), filed a civil
rights complaint against Wexford Health Source[s], Inc., Dr.
Ashraft [sic], and Dr. Barrea, alleging that defendants
denied him constitutionally adequate medical care when they
failed to prescribe Harvoni to treat plaintiff's chronic
Hepatitis C infection (“HCV”). ECF 1 at 1-3.
Plaintiff's complaint, dated May 30, 2016, seeks damages
as well as injunctive relief. ECF 1 at 3. Accompanying his
complaint is his motion for emergency injunctive relief. ECF
Plaintiff indicates that in 2012, he began treatment for HCV
with Interpheron but did not tolerate the side effects of the
treatment well and discontinued same. Id. at 5. He
states that he was advised by the chronic case nurse
”Becca” that when he was ready to complete the
treatment he could request to resume same. ECF 1 at 1-3.
In 2015, plaintiff learned that Interpheron therapy had been
discontinued as the treatment for HCV and that a new
treatment, Harvoni, was available. Id. He was
advised that Harvoni only required 6-8 weeks of treatment and
had fewer side effects. Id. Plaintiff requested to
be provided Harvoni to treat his HCV. Id.
Several months passed with no treatment. Id. at 5-6.
Plaintiff states that during this time he began to experience
symptoms of his HCV infection, including soreness on his
right side, yellowing of the eyes, and loss of energy.
Id. at 6. He wrote several sick calls slips
requesting to be seen by medical staff but they were not
On May 9, 2016, plaintiff submitted an administrative remedy
(“ARP”) regarding the lack of treatment for his
HCV. Id. Plaintiff was advised that the prison was
treating patients in order of those with the “highest
level” beginning with level 4; once all those at level
4 were treated the next highest level would be treated.
Id. Plaintiff expressed his concern that if medical
staff waited to treat him, by the time he would receive
treatment he would be one of the highest levels and would
suffer greater damage to his liver. Id. at 6-7.
reiterates his claims that the defendants have been
deliberately indifferent to his serious medical needs. Pevia
II, ECF 1 at 5. He states that in 2013he underwent a liver
biopsy due to suffering from HCV. Id. at 3. After
the biopsy he began treatment with Interpheron, but he needed
to discontinue the medication due to side effects. In
February of 2016,  plaintiff learned of new medications
provided by Wexford to those suffering from HCV. Plaintiff
inquired about receiving the new medication, Harvoni, but was
advised that it could be two years before he would be
treated, as those with more severe symptoms needed to be
treated first and that approach was cost effective.
Id. Additionally, plaintiff indicates that he
exhausted his administrative remedies regarding the denial of
treatment with Harvoni. Id. at 4.
Department of Public Safety and Correctional Services
Protocol For Treatment of HCV
Development of Protocol
explain the development and clinical application of the
protocol for HCV infection control in several detailed
declarations provided by Dr. Sharon Baucom, the Executive
Director of Clinical Services for the Maryland Department of
Public Safety and Correctional Services
(“DPSCS”), and Dr. Robustiano Barrera, M.D., a
licensed physician who is employed by Wexford to provide
services to inmates of DPSCS. See Pevia I, ECF 18-5
(Declaration of Baucom, 1/26/15); Pevia II, ECF 10-2 (Declaration
of Baucom, 7/25/17); ECF 10-3 (Declaration of Baucom,
7/25/17); Pevia I, ECF 18-6 (Declaration of Barrera,
2005, physicians and other personnel contracted by DPSCS have
treated inmates with HCV using protocols approved by the
University of Maryland Institute of Human Virology Specialist
in Infectious Disease, as well as specialists from Johns
Hopkins University. Pevia II, ECF 10-2, ¶ 15. According
to Dr. Baucom, Maryland leads most state correctional systems
in the number of inmates who have been successfully treated
for HCV using antiviral medication. Id.
grades of HCV are described in relation to
necrosis/inflammation of the liver, as follows: 1, minimal;
2, mild; 3, moderate; and 4, severe. Id. The levels
of “staging” are described in regard to scarring
of the liver, as follows: 1- no scarring; 2- mild scarring;
3-moderate scarring; and 4- severe scarring
“cirrhosis.” Pevia I, ECF 18-6 ¶ 11; Pevia
II, ECF 10-3, ¶ 8.
2007, DPSCS hired a University of Maryland Medical System
(“UMMS”) infectious disease specialist to develop
guidelines for the care of HCV and HIV positive inmates.
Pevia II, ECF 10-2, ¶ 17. The same specialist was
contracted by Wexford in 2011 to continue to provide guidance
and input regarding HCV as well as other infectious diseases.
Id. The DPSCS guidelines for HCV are formulated by
the specialist, with medication reviews and contract
negotiations by a clinical pharmacologist who holds a
doctorate in Pharmacology and is employed by Correct RX, the
pharmacy vendor. Id. Together they review the
recommendations made with the DPSCS Medical Director, the
Infection Control Director of Wexford, and the infection
control nursing staff, who facilitate the adoption of the
policy changes as part of DPSCS's policy and procedures.
Id. Baucom participates in the Pharmacy and
Therapuetic Committee that reviews the recommendations for
new HCV medication and the indicators for their application
in the system. Id.
January 2011, DPSCS issued an update to the policy regarding
HCV infection control. Pevia I, ECF 18-4 (DPSCS Clinical
Services “Infection Control Manual, ” Chapter 2,
“Medical Management Of Hepatitis”); id.,
ECF 18-5, ¶ 4; Pevia II, ECF 10-2, ¶ 4. The policy
provides that once an inmate tests positive for HCV, the
inmate is to be enrolled in a Chronic Care Clinic
(“CCC”) for education, medical evaluation, and
treatment. Pevia I, ECF 18-4, at 1, ¶ I; Id.,
ECF 18-6, ¶ 5; Pevia II, ECF 10-2, ¶ 4;
Id., ECF 10-3, ¶ 4. The policy also provides
that the inmate is to receive Hepatitis A and B vaccines and
counselling on the nature, potential effects, and management
of HCV. Pevia I, ECF 18-4, at 2, ¶¶ D & E;
id., ECF 18-6, ¶ 5; Pevia II, ECF 10-3, ¶
drug therapy treatments for HCV are evaluated and considered
by a DPSCS HCV Panel (the “Panel”). Pevia II, ECF
10-2, ¶ 5. The Panel is composed of the Wexford Regional
Medical Directors, site specific providers/inspection control
nurse support staff, statewide medical and mental health
providers for Wexford, employees of MHM (the contractor of
mental health services), the statewide clinical
pharmacologist from Correct RX, the statewide epidemiologist
for Wexford. and the Wexford statewide infectious disease
specialist. Pevia I, ECF 18-5, ¶ 5; Id., ECF
18-6, ¶ 7; Pevia II, ECF 10-2, ¶ 5. Non-medical
correctional personnel, including the Secretary of DPSCS and
the wardens of individual institutions, do not play an active
role in the decisions of the Panel. Pevia II, ECF 10-2,
Panel is chaired by Wexford's infectious disease
specialist. Pevia II, ECF 10-2, ¶ 6. It is facilitated
by Wexford's statewide epidemiologist and Wexford's
statewide medical director. Id. Baucom does not
participate directly in panel activities. Pevia II, ECF 10-2,
¶ 5. DPSCS's representation on the Panel is limited
to a registered nurse whose presence is designed to insure
adherence to mandated testing, laboratory work, vaccinations,
etc., which by policy are required to be completed before an
inmate may be reviewed by the Panel for treatment.
Id. ¶ 6. The infectious disease specialist and
the HCV Panel participants determine whether to treat HCV
infected inmates, including whether to biopsy the
inmate's liver, without Dr. Baucom's influence.
Id., ¶ 16. However, Dr. Baucom provides insight
into the policy and procedures that govern the process.
Id. She reviews any audits completed by the DPSCS
nurses who sit on the Panel. Id.
Dr. Baucom avers that her influence, as it relates to policy,
cost, and other system approaches, has permitted the
contracting staff to be more aggressive in offering new drug
therapies, as the cost for the HCV medication is carried on
the DPSCS pharmacy budget, not the medical contractor's
costs. Id. She also asserts that the DPSCS treats
inmates with newer HCV drugs more than other comparable
correctional state systems. Id.
DPSCS Pharmacy and Therapeutic Committee is chaired by
Correct RX's statewide clinical pharmacist and co-chaired
by DPSCS Executive Director of Clinical Services. Pevia II,
ECF 10-2, ¶ 7. Committee members include the regional
medical directors for Wexford, the Wexford statewide medical
director, the MHM statewide psychiatrist, regional clinical
pharmacists from Correct RX, and statewide nursing directors
for DPSCS and Wexford. Id. The committee develops
and approves additions or deletions from the formulary, which
includes medication to treat HCV. Id.
DPSCS Pharmacy and Therapeutic Committee evaluates different
medications and treatments for infectious diseases, including
HCV, for use within DPSCS. Pevia, II, ECF 10-2, ¶¶
7, 8, 14. To that end, the pharmacy vendor has met with
companies producing newer HCV medications to determine
additional clinical treatment option combinations and in
order to solicit discount pricing. Pevia II, ECF 10-2, ¶
13. Notably, “on a case-by-case basis, ” there
are “exceptions to the recommendations” for
treatment of inmates. Id. ¶ 9.
to be implemented by DPSCS for the treatment of infectious
diseases, including HCV, are drafted by the contractors for
Medical and Pharmacy, an infectious disease specialist
consultant for Wexford, and the statewide clinical
pharmacologist for Correct RX, for review by the DPSCS
Executive Director of Clinical Services. Pevia II, ECF 10-2,
¶ 8. Together they research the policies of other
states, the Centers for Disease Control, the Federal Bureau
of Prisons, and community standard references. Id.
Rationales for their recommendations are provided.
Id. Where a policy is drafted concerning the use of
new drugs, as in the case of any other directive or policy,
the proposal is circulated for comment among all other
contractor representatives, and their input is solicited and
evaluated before the final draft is adopted and made
Baucom avers that as a member of the Pharmacy and Therapeutic
Committee she assists in making the final decision for
approval or denial of new HCV medications or treatment. Pevia
II, ECF 10-2, ¶ 10. These decisions are made by
following the guidelines formulated in the policy created by
the combined expert resources of the contractors who comprise
the Panel. Id. However, Dr. Baucom retains
“the authority to request second opinions or
considerations from other sources if not included as sources
of treatment protocols including the policy on HCV therapy
provided by the Maryland Department of Health and Mental
Hygiene, the Veterans Administration, ” or a state with
similar “demographics regarding the correctional
population.” Id. ¶ 11.
to the recommendations made in the policies regarding
antiviral therapies may be warranted and may be presented to
Dr. Baucom, on a “case-by-case basis, ” by the
Wexford infectious disease specialist consultant and the
Correct RX statewide clinical pharmacologist, on post-panel
review, to alert Dr. Baucom to circumstances regarding a
specific inmate's condition that may require an exception
to the policy. Pevia II, ECF 10-2, ¶ 9. Although Dr.
Baucom does not overrule the decision, she may provide
additional input or request additional documentation from a
risk management perspective. Id.
Dr. Baucom advises that DPSCS has a census of over 2, 000
known HCV infected inmates and treats more patients for HCV
disease than a majority of states. Pevia II, ECF 10-2, ¶
12. She indicates that, in addition to utilizing the
expertise of those who originated the Maryland DPSCS HCV
policy, the Panel has worked with other correctional systems
to identify a policy that allows for a stratification of
treatment options. Id. Baucom notes that the Federal
Bureau of Prisons developed a protocol specifically for the
new HCV regimens which prioritized for treatment the most
severely impacted patients, based upon several diagnostic
principles. Id. DPSCS apparently adopted a similar
protocol and, once the most critical cases were addressed,
DPSCS expanded the priority groups. Id. Baucom avers
that the newer HCV medications are provided to the most
severe cases and there are plans to expand the opportunity to
inmates who are non-responders or relapsers with various
levels of moderate fibrosis. Id., ¶ 14.
medical experts aver that, given the potential side effects
and expense of antiviral therapy, it is not appropriate to
begin antiviral therapy for genotype 1 HCV based solely upon
a positive test for HCV, when no clinical symptoms exist.
Pevia I, ECF 18-6, ¶ 7; Pevia II, ECF 10-3, ¶ 6. An
inmate with a HCV genotype I must have a liver biopsy in
order to obtain antiviral treatment. Pevia I, ECF 18-6,
¶ 5. Drs. Barrera and Baucom aver that a person infected
with HCV, particularly genotype 1, may not know he/she is
infected or manifest adverse symptoms. Pevia I, ECF 18-6,
¶ 6; Pevia II, ECF 10-3, ¶ 5. Indeed, they claim
that many individuals continue for years, if not
indefinitely, without manifesting adverse symptoms.
Id. Therefore, unless an inmate's HCV infection
has progressed to a point where antiviral treatment is deemed
medically necessary, the inmate is simply monitored in the
CCC. Id. When the condition is in an acute stage the
patient may report a spectrum of symptoms, including a
general feeling of lethargy, loss of appetite, nausea,
vomiting, diarrhea, muscle aches, and abdominal discomfort.
Pevia II, ECF 10-3, ¶ 5.
who are eligible for antiviral drug treatment may be asked to
undergo laboratory blood tests, as well as a consultation
with a gastrointestinal (GI) or infectious disease (ID)
specialist, if a liver biopsy and antiviral therapy are under
consideration. Pevia I, ECF 18-4 at 4, ¶ E.5 & F;
ECF 18-6, ¶ 5; Pevia II, ECF 10-3, ¶ 4. However,
inmates who test positive for HCV genotype 2 or 3, and
inmates who are co-infected with HCV and the human
immunodeficiency virus (“HIV”), are not required
to undergo a liver biopsy before beginning antiviral
treatment. Pevia I, ECF 18-4, ¶ F.3; Id. ECF
18-6, ¶ 5; Pevia II, ECF 10-3, ¶ 4. All other HCV
positive inmates must have a liver biopsy prior to beginning
antiviral treatment, unless the ID/GI specialist recommends
an alternative assessment tool. Pevia I, ECF 18-4, ¶
F.3.c.; ECF 18-6, ¶ 5. The liver biopsy is used to
determine the status of the inmate's HCV infection and
the appropriate course of treatment. Pevia I, ECF 18-6,
¶ 6; Pevia II, ECF 10-3, ¶ 5. If a patient refuses
a liver biopsy, antiviral therapy will not be pursued. Pevia
I, ECF 18-4 at 6, ¶ G.3.d; Id., Pevia II, ECF
10-3, ¶ 5.
inmate's liver biopsy is reviewed by the Panel. Pevia II,
ECF 10-3, ¶ 6. If the Panel determines the biopsy
indicates the patient is at a stage of infection where
antiviral therapy is warranted, the Panel must approve a
specific antiviral therapy regimen and determine when it will
be administered. Pevia I, ECF 18-6, ¶ 7. Antiviral
therapy will be approved if the “panel determines: a)
the biopsy indicates the patient is at a stage of infection
warranting antiviral therapy; b) approves going forward with
a specific antiviral therapy regimen; and c) establishes the
prioritization of the therapy.” Pevia II, ECF 10-3,
to Dr. Barrera, the use of antiviral medication to treat
chronic HCV infection has two goals. Pevia I, ECF 18-6,
¶ 8. The first goal “is to achieve sustained
eradication of HCV, which is defined as the persistent
absence of HCV RNA in serum six months or more after
completing antiviral treatment. The second is to prevent
progression to cirrhosis, hepatocellular carcinoma, and
decompensated liver disease requiring liver
transplantation.” Id. The panel has evaluated
and continues to evaluate different medications and
treatments for HCV for use within the DPSCS system.
Id., ¶¶ 10-11.
Barrera indicates that Pegylated Interferon, as a modified
form of alpha interferon, in which polyethylene glycol is
added and which is taken weekly in a dosage based on body
weight, and Ribavirin, which is an oral antiviral usually
taken twice a day, and which is also dosed by body weight,
were the primary HCV treatments approved for system-wide use
by DPSC. Pevia I, ECF 18-6, ¶ 10. The efficacy of
Pegylated Interferon and Ribavirin vary from patient to
patient. Id., ¶ 8. Dr. Baucom confirms that at
the time relevant to plaintiff's Complaint, Pegylated