United States District Court, M.D. Pennsylvania
D. Mariani United States District Judge.
Introduction & Procedural History
before the Court is Plaintiffs Motion for a Preliminary
Injunction, (Doc. 7), filed October 10, 2016. Plaintiff, a
state prisoner, seeks this injunction to require Defendants
to immediately treat his active hepatitis C infection with
direct-acting antiviral drugs. (Doc. 7). This is not
Plaintiff's first attempt at such relief. On August 31,
2016, this Court, in a related case, denied Plaintiffs
request for a preliminary injunction seeking the same relief.
Abu-Jamal v. Kerestes, 2016 WL 4574646 (M.D. Pa
2016). Thus, to fully understand the posture in
which the present case comes before this Court, a brief
history of both cases is necessary.
Mumia Abu-Jamal, filed a complaint in Abu-Jamal 1 on
May 18, 2015, "claiming violations of the right to
association and access to the courts." Abu-Jamal v.
Kerestes, 2016 WL 4574646, at *1. On August 24, 2015,
Plaintiff filed a motion for a preliminary injunction seeking
to compel Defendants-various medical staff involved in the
treatment of his medical conditions and several Pennsylvania
Department of Correction ("DOC") staff-to provide
him with "immediate treatment of his hepatitis C with
recently developed direct-acting antiviral ("DM")
medication." Id. This Court held a three day
evidentiary hearing on the matter in December of 2015.
Opinion issued on August 31, 2016, this Court found that the
"DOC has an interim protocol to address patients with
hepatitis C" and that, under that protocol, a
"Hepatitis C Treatment Committee has the ultimate
authority to decide whether" an inmate is treated with
DDA medications. Id. at *5, *8. This Court went on
to conclude that "[t]he protocol as currently adopted
and implemented presents deliberate indifference to the known
risks which follow from untreated chronic hepatitis C."
Id. at *9. This Court, however, did not issue a
preliminary injunction because "p]t was the Hepatitis C
Treatment Committee who made the decision not to give
Plaintiff DAA medications and that had, and continues to
have, the ultimate authority to determine whether or not
Plaintiff will receive the DAA medications, " and
"[t]he named Defendants [were] not members of the
Hepatitis C Treatment Review Committee." Id.
Thus, this Court concluded that it could not "properly
issue an injunction against the named Defendants, as the
record contain[ed] no evidence that they ha[d] authority to
alter the interim protocol or its application to
Plaintiff." Id. at *10.
September 30, 2016, Plaintiff filed the Complaint in this
action alleging a single count titled "Deprivation of
Eighth Amendment Right to Medical Care for Hepatitis C"
and naming the following as defendants: John Wetzel,
Secretary of Pennsylvania Department of Corrections; Dr. Paul
Noel, DOC Bureau of Health Care Services Chief of Clinical
Services, member of Hepatitis C Treatment Committee; Bureau
of Health Care Services Assistant Medical Director, member of
Hepatitis C Treatment Committee; Bureau of Health Care
Services Infection Control Coordinator, member of Hepatitis C
Treatment Committee; Correct Care Solutions representative on
the Hepatitis C Treatment Committee; Correct Care Solutions;
Joseph Silva, DOC Director of Bureau of Health Care Services;
and Treating Physician SCI Mahanoy. (Id.). On
Octobers, 2016, Plaintiff filed a Motion for a Preliminary
Injunction seeking the relief this Court denied in
Abu-Jamal v. Kerestes. (Doc. 7). In support thereof,
Plaintiff attached the transcripts from the evidentiary
hearing held in Abu-Jamal 1. During a conference
call held on December 1, 2016, all parties agreed that a new
evidentiary hearing was not necessary and that this Court
could decide the present motion on the basis of the exhibits
filed. The issue has been fully briefed and is
now ripe for decision. For the reasons set forth below, the
Court will grant Plaintiffs Motion.
Findings of Facts
the Court is relying on the testimony that was given in
Abu-Jamal 1, the Court adopts the following findings
of facts from Abu-Jamal v. Kerestes:
C and Treatment Thereof
DOC Defendants' expert witness Dr. Jay Cowan is licensed
to practice medicine in Pennsylvania, New York, and New
Jersey and is double board-certified in internal medicine and
gastroenterology and hepatology. (Cowan Test, Dec. 22, 2015,
Doc. 95 at 196:9-13, 197:10-11). He has been the Medical
Director of the Rikers Island correctional facility since
2011. (Id. at 198:1-4). Dr. Cowan has treated
patients with hepatitis C in his capacity as the Chief of
Gastroenterology at North General Hospital in Harlem, New
York City, in private practice in Harlem, through his work in
Harlem Hospital's Division of Gastroenterology, and in
his work at Rikers Island. (Id. at 197:20-198:11).
Chronic hepatitis C is a serious disease that is a major
public health issue in the United States and worldwide.
(Cowan Test., Dec. 23, 2015, Doc. 96 at 20:17-22). It is the
number one reason for liver transplants in the United States
at present, as well as the number one cause of liver cancer
in the United States. (Id. at 21:22-22:2).
Hepatitis C is contagious and transmitted primarily by blood.
(Cowan Test., Dec. 23, 2015 at 22:3-5).
Cowan testified that of those individuals infected with
Hepatitis C, 75 percent to 85 percent will develop chronic
hepatitis, which is inflammation of the liver. Of those who
develop chronic hepatitis, 20 percent to 30 percent will go
on to develop cirrhosis over the next 10 to 20 years. Of the
individuals who develop cirrhosis, two percent to seven
percent will develop hepatocellular carcinoma. (Cowan Test.,
Dec. 22, 2015 at 199:16-25). During cross examination, Dr.
Cowan also testified that of those exposed to hepatitis C,
between 50 percent and 85 percent will develop chronic
hepatitis. (Cowan Test., Dec. 23, 2015 at 21:7-8).
Cirrhosis represents a late stage of progressive hepatic
fibrosis, characterized by distortion in the liver
architecture and the formation of regenerative nodules that
no longer allow the liver to function properly. (Cowan Test.,
Dec. 22, 2015 at 201:21-202:1).
Individuals with cirrhosis often experience a decrease in the
number of platelets circulating in their blood. Cirrhosis may
have an impact on both platelet production and platelet
survival. (Id. at 204:18-205:1).
Individuals with cirrhosis are at an increased risk for
ascites, which is an accumulation of peritoneal fluid in the
abdominal cavity, for portal hypertension, for hepatic
encephalopathy, which is mental confusion associated with the
increased toxic burden that the liver cannot filter out, and
for the occurrence of jaundice and/or rising bilirubin levels
in the bloodstream. These are markers of decompensated
cirrhosis. (Id. at 207:23-208:14).
Metavir scores indicate the level of fibrosis in the liver on
a five-point scale from F0 to F4. F2 and F3 mark the
progression of fibrosis from less severe to more severe, with
F4 marking cirrhosis. (Id. at 202:9-13).
Cowan testified that very often, medical professionals cannot
predict the rate of progression of fibrosis. (Id. at
Correct Care Solutions ("CCS") is the contracted
health provider for the DOC. (Cowan Test, Dec. 23, 2015 at
Cowan is a paid consultant with the Correct Care Solutions
Hepatitis C Review Committee at DOC. (Id. at
4:8-13). Dr. Cowan also testified that he "serve[s] on
the Correct Care Solutions Hepatitis C Review
Committee." (Id. at 67:16-17).
Cowan testified that there is "not very good concordance
between physical symptoms [of hepatitis C] that a patient may
experience and their degree of fibrosis or cirrhosis, "
such that one cannot say at what level of fibrosis or
cirrhosis a person will begin to experience physical symptoms
related to hepatitis C. (Cowan Test., Dec. 22, 2015 at
landscape of treatments for hepatitis C is evolving very
rapidly. (Id. at 201:8-9).
Sovaldi and Harvoni are DM medications for the treatment of
hepatitis C. Sovaldi was first approved by the Food and Drug
Administration in December 2013. Harvoni was first approved
in October 2014. (Id. at 201:1-6). These drugs have
"relative low-risk side effects" and "high
success rates of 90 percent plus." (Id. at
Cowan agreed that, on average, "with the new drug,
there's a 90 to 95 percent chance that the treatment will
be successful." (Cowan Test, Dec. 23, 2015 at 28:5-7;
see also Noel Test, Dec. 23, 2015, at 129:10-13 (agreeing
that if Plaintiff were treated with direct-acting antivirals,
there is a 90 to 95 chance he would be cured of Hepatitis
"The goal of Hepatitis C anti-viral treatment is to
achieve a sustained virological response (SVR), defined as
undetectable HCV virus in the blood." (Pa. Dep't of
Cor., Interim Hepatitis C Protocol, Pl.'s Ex. 30 at
"Achieving an SVR may significantly decrease the risk of
disease progression and the development of decompensated
cirrhosis, liver cancer, liver failure, and death."
(Id.). Dr. Cowan agreed with the statement that
patients cured of HCV infection experience numerous benefits,
including a decrease in liver inflammation and a reduction in
liver fibrosis. (Cowan Test., Dec. 23, 2015 at 25:19-25). He
also agreed with the statement that delay in treatment
decreases the benefit of SVR. (Id. at 26:4-7). Dr.
Cowan further agreed that successful treatment of hepatitis C
has been shown to reduce, if not eliminate, fatigue in
patients with chronic hepatitis C. (Id. at 28:1-4).
October 2015 guidelines from the American Association for the
Study of Liver Diseases ("AASLD") and Infectious
Diseases Society of America ("IDSA") entitled
"When and in Whom to Initiate HCV Therapy"
"recommend treatment [using DAA therapies] for all
patients with chronic HCV ["hepatitis C virus"]
infection, except those with short life expectancies that
cannot be remediated by treating HCV, by transplantation, or
by other directed therapy." (Am. Ass'n for the Study
of Liver Diseases & Infectious Diseases Soc'y of Am.,
When and in Whom to Initiate HCV Therapy, Pl.'s Ex. 18 at
1; see also Cowan Test., Dec. 23, 2015 at 24:9-14).
Centers for Disease Control ("CDC") states that the
standard of care in hepatitis C treatment in the United
States is treatment with direct-acting antiviral agents such
as Harvoni and Viekira Pak. (Ctr. for Disease Control,
Surveillance for Viral Hepatitis - United States, 2013,
Pl.'s Ex. 17 at 5-6). The CDC refers providers caring for
hepatitis C-infected patients to the AASLD/IDSA guidance for
continuously updated information regarding hepatitis C
treatment. (Id. at 6).
Cowan agreed that the CDC points to the AASLD/IDSA guidelines
as the standard of care for the treatment of Hepatitis C.
(Cowan Test, Dec. 23, 2015 at 33:15-34:9).
Cowan testified that he agreed that the same standard of care
as to hepatitis C treatment that is applicable to the
community at large should apply in a correctional setting.
(Id. at 32:17-20).
Cowan testified that "[a]t the current time, given the
backlog of patients that have this disease, it is [his]
recommendation . . . that the sickest patients be treated
first. Those are the patients with fibrosis scores of 3 and
4." (Id. at 66:19-22).
Cowan testified "[i]f [a] patient had Chronic Hepatitis
C, in private practice, [he] would engage in a conversation
with the patient's insurance company and recommend the
current AASLD Guidelines" and that, if the patient could
pay for it, he would recommend treatment. (Id. at
Cowan testified that "[t]here is a fiscal component
involved" in the determination of who should and should
not receive treatment with DAA medications for hepatitis C.
(Id. at 82:18-25).
Paul Noel is the Chief of Clinical Services for DOC, a
position which he has held since 2014. (Noel Test, Dec. 23,
2015, Doc. 96 at 90:3-7). Dr. Noel has worked in correctional
health care in Pennsylvania since 1994. (Id. at
Noel testified that in his role as DOC's Chief of
Clinical Services he is "involved with oversight of the
medical contract... [he is] the point of contact to make sure
that the clinical services are appropriate, according to
contract, and policies and procedures performed by the
medical contractor. [He] deal[s] more directly with [the
medical contractor's] corresponding State Medical
Director on issues of quality improvement, policies and
procedures, things like that." (Id. at
Noel agreed that the most recent AASLD Guidelines on the
treatment of hepatitis C recommend treatment for everyone.
(Id. at 130:16-23).
Noel testified that, with respect to the AASLD Guidelines,
We review them, we take them into consideration, they're
part of the big picture, they're not the single bullet
that has everything right, it's a much more complicated -
it would be nice if we could go to one document and everybody
follow it and everything would be wonderful, it just
doesn't work that way. So the AASLD has a large voice at
the table, if that's your question. We don't
necessarily do just what the AASLD says.
(Id. at 131:13).
Noel testified that in or about December 2013, DOC ceased
administration of then-current medications because "the
AASLD made specific recommendations to cease those current
medications that we were using. And that's why they were
no longer used, so it's not like we had the option to
keep doing it." (Id. at 133:9-134:1).
Interim Hepatitis C Protocol
Noel testified that DOC has an interim protocol to address
patients with hepatitis C. (Noel Test, Dec. 23, 2015 at
interim protocol was issued on November 13, 2015 and
effective November 20, 2015. (Pl.'s Ex. 30).
Noel testified that the interim protocol "was formulated
to address those patients with Hepatitis C who are in the
most need of treatment right away." (Noel Test,, Dec.
23, 2015 at 99:24-25). He testified that the policy is
"interim" in the sense that it will be adjusted as
DOC treats current patients and as science and hepatitis C
treatment guidelines in the community and within the prison
system evolve. (Id. at 99:23-100:9).
Noel testified that the interim protocol replaced a prior
hepatitis C protocol, which "was a protocol for
medications that are no longer used." (id. at
Noel was involved in developing the interim protocol and had
assisted in developing the previous protocol. (Id.
at 101:7-13). He also testified that he helped draft the
interim protocol. (Id. at 126:8-14).
DOC's interim hepatitis C protocol is a
"prioritization protocol, " which Dr. Noel
testified is designed "to identify those with the most
serious liver disease and to treat them first, and then, as
they're treated, move down the list to the lower
priorities, from high priority to lower priority."
(Id. at 102:17-103:1; see also Pl.'s Ex. 30 at 2
("The purpose of this Hepatitis C Protocol is to
prioritize candidates for anti-viral treatment.")).
Noel testified that the protocol does not preclude hepatitis
C treatment from any inmate who has hepatitis C. (Noel.
Test., Dec. 23, 2015 at 103:3-7).
protocol defines patients with chronic hepatitis C as those
with a documented detectable viral load and includes under
this label "all patients on the continuum from no
fibrosis -> fibrosis -> compensated cirrhosis ->
decompensated cirrhosis." (Pl.'s Ex. 30 at 2).
Patients with "Chronic Hepatitis C (Compensated)"
are defined by the protocol as those having the presence of
"(1) a previous liver biopsy with fibrosis Metavir stage
4 or Ishak stage 6; (2) a Platelet Count of < 100,
000/mcL; (3) a Hepatitis C Antiviral Long-term Treatment
Against Cirrhosis (HALT-C) probability of >60%; and/or (4)
no evidence of jaundice, ascites, bleeding esophageal
varices, or hepatic encephalopathy." (Pl.'s Ex. 30
Patients with "Chronic Hepatitis C (Decompensated)"
are defined by the protocol as those that display
"evidence of jaundice, ascites, bleeding esophageal
varices, or hepatic encephalopathy." (Pl.'s Ex. 30
According to the protocol, all patients with chronic
hepatitis C will be entered into the Liver Disease Chronic
Care Clinic and given a diagnosis of "no cirrhosis,
" "compensated cirrhosis, " or
"decompensated cirrhosis." (Pl.'s Ex. 30 at 3).
Patients with "no cirrhosis" will be seen for a
follow-up Clinic appointment every twelve months, patients
with "compensated cirrhosis" will be seen for a
follow-up every six months, and patients with
"decompensated cirrhosis" will be seen for a
follow-up every month. (Id. at 4).
Noel testified that inmates with chronic hepatitis C will be
"put into the Chronic Care Clinic, " which he
defined as "a tracking system to ensure that they are
seen on a regular basis." According to Dr. Noel's
testimony, "[t]he vast majority of them will live in
general population and just be followed by one of [the]
providers on-site, along with an Infectious Control
Nurse...." (Noel Test, Dec. 23, 2015, at 104:16-21).
According to Dr. Noel, "[i]f a patient is absolutely 100
percent asymptomatic, . . . they're seen at least once a
year." (Id. at 106:1-5). Dr. Noel testified
that "[o]nce they start[ ] developing advanced fibrosis
or cirrhosis ... it goes to every six months And if
they're really sick, where they have decompensated
cirrhosis and in end stage liver disease, they're seen
every month." (Id. at 106:7-11). According to
Dr. Noel, "[c]linicians can see [patients in the Chronic
Care Clinic] more often, as they see fit." (Id.
According to the interim protocol, "it is most important
to identify patients with advanced compensated cirrhosis and
early decompensated cirrhosis ... as the highest priority for
anti-viral treatment" because "patients with
decompensated cirrhosis are at high risk in drug therapy and
their treatment options may be limited to liver
transplantation." (Pl.'s Ex. 30 at 5, ¶ 3).
According to the interim protocol, "[t]he population
most in need of evaluation will be defined as those with
platelet counts below 100, 000/mcL and those with HALT-C
predicted likelihood of cirrhosis above 60%" and
"[t]hese patients will be individually evaluated for
prioritization in ascending order of platelet count...."
(Pl.'s Ex. 30 at 5, ¶ 5).
interim protocol states that a patient with either a platelet
count below 100, 000/mcL or a HALT-C probability of cirrhosis
> 60 percent will have an initial review of his or her
medical charts only at his or her home site. (Id. at
6, ¶ 6). If no medical or administrative exclusionary
indications to anti-viral treatment are found at the home
site, the correctional Health Care Administrator of the home
site will forward a Hepatitis C Treatment Referral Form to
the Bureau of Health Care Services Infection Control
Coordinator for further evaluation, possible recommendations
for further testing, and final determination. (Pl.'s Ex.
30 at 6, ¶ 8).
Noel testified that if inmates have "a platelet count
less of a hundred thousand or a HALT-C score of greater than
60 percent, they would be identified as someone who needs
further evaluation" and would then be referred to the
Central Office's Hepatitis C Review Committee. (Noel
Test., Dec. 23, 2015, at 104:23-105:4).
According to the interim protocol, the Hepatitis C Treatment
Committee consists of at least four people: Dr. Noel, as the
DOC's Bureau of Health Care Services Chief of Clinical
Services; the Bureau of Health Care Services Assistant
Medical Director; the Statewide Medical Director for Correct
Care Solutions; and the Bureau of Health Care Services
Infection Control Coordinator. (Pl.'s Ex. 30 at 7, ¶
1). Dr. Noel testified that the Committee consists of
himself, as "the Chief of Clinical Services, the
representative from the medical contractor CSS, Infectious
Control nurse, the Assistant Medical Director for the DOC,
and anyone [the Committee] might invite to participate in any
difficult cases." (Noel Test., Dec. 23, 2015 at
individual's clinical status will be reviewed by the
Hepatitis C Treatment Committee for prioritization for
treatment with DAA medications. (Pl.'s Ex. 30 at 7,
¶ 1). According to Dr. Noel's testimony, the Review
Committee would then "sit down and manually go through
the patient's chart with some information provided by the
site, possibly, a phone conference with the Site Medical
Director" and a "determination then would be made
if there was some further testing or further evaluation that
needed to be done." (Noel Test, Dec. 23, 2015 at
According to the protocol, if upon review the Committee
determines the patient is a candidate for treatment with DAA
medication, an esophageal gastroendoscopy ("EGD")
will be approved to evaluate the patient for esophageal
varices, (Pl.'s Ex. 30 at 7, ¶ 2). According to Dr.
Noel, under the current protocol, the Review Committee makes
"a decision of whether or not to refer and schedule a
patient for... an EGD, " and, if so referred, the inmate
would be sent off site to "have an EGD performed to
determine whether or not they have esophageal varices."
(Noel Test., Dec. 23, 2015, at 105:12-17).
According to the protocol, if the endoscopy documents the
presence of esophageal varices, the patient will be approved
for referral to a supervising physician - that is, a
physician licensed in Pennsylvania and experienced in the
treatment of Hepatitis C utilizing the most current
medications who will treat the patient via telemedicine.
(pl.'s Ex. 30 at 7, ¶¶ 3, 5). Dr. Noel
testified that "[esophageal varices are a direct
indication of portal hypertension and correlates with those
[patients] with the most severe disease that need ...