United States District Court, M.D. Tennessee, Nashville Division
GREGORY ATKINS, et al., on behalf of themselves and all others similarly situated, Plaintiffs,
TONY C. PARKER and DR. KENNETH WILLIAMS, Defendants.
FINDINGS OF FACT AND CONCLUSIONS OF LAW
WAVERLY D. CRENSHAW, JR. CHIEF UNITED STATES DISTRICT JUDGE.
case, at its heart, is about the adequacy of medical
treatment for state inmates with chronic Hepatitis C
(“HCV”) viral infections. Plaintiffs challenge
the failure of current Tennessee Department of Corrections
(“TDOC”) policies and protocols to timely provide
Direct Acting Antiviral drugs (“DAAs”) to treat
all HCV inmates constitutes deliberate indifference to their
serious medical needs in violation of the Eighth and
Fourteenth Amendments. Plaintiffs and their class seek
prospective injunctive and declaratory relief under 42 U.S.C.
§ 1983 against TDOC Commissioner Tony C. Parker and
Chief Medical Officer Dr. Kenneth Williams
(“Defendants”). In response, Defendants contend
TDOC's 2019 HCV treatment policies and protocols are
improved, objectively reasonable, and the result of
subjective medical judgment.
Court held a bench trial on July 16, 2019 through July 19,
2019. Based on the record before the Court, the Court finds
that Defendant's HCV treatment policies as written and as
applied are not perfect, but Plaintiffs have failed to prove,
by a preponderance of the evidence, that TDOC's current
HCV treatment policy and protocols violate Plaintiffs'
Eighth Amendment rights.
Court enters the following Findings of Fact and Conclusions
of Law in accordance with Rule 52(a) of the Federal Rules of
The Class and Claim
Plaintiffs are a class of TDOC inmates diagnosed with HCV who
have not yet received treatment at the time of trial. (Doc.
No. 219.) Specifically, the class consists of:
All persons currently incarcerated in any facility under the
supervision or control of [TDOC] or persons incarcerated in a
public or privately owned facility for whom [TDOC] has
ultimate responsibility for their medical care and who have
at least 12 weeks or more remaining to serve on their
sentences and are either currently diagnosed with [HCV] or
are determined to have [HCV] after an appropriate screening
test has been administered by [TDOC].
(Doc. No. 32.)
Specifically, Plaintiffs allege that the practices and
procedures implemented by Defendants for the diagnosis,
evaluation, and approval for treatment with DAAs of HCV
inmates, do not meet the current medical standard of care,
subject HCV inmates to a substantial risk of harm or death,
and constitute deliberate indifference in violation of the
right to be free from cruel and unusual punishment guaranteed
by the Eighth and Fourteenth Amendments. (Id.)
There are approximately 21, 000 inmates in TDOC custody.
(Doc. No. 198, Tr. Stip. No. 20.)
the time of trial, there were approximately 4, 740 inmates
known to be infected with chronic HCV. (Id., Trial
Stip. No. 21.)
number may be higher because a number of inmates have not yet
been tested. (No. 250, Tr. Vol. 1 at 115-117 (Wiley); Doc.
No. 251, Tr. Vol. 2 at 199-200 (Williams)).
of July 16, 2019, TDOC has prescribed DAAs for approximately
450 inmates (P. Ex. 84; Doc. No. 251, Tr. Vol. 2 at 166
(Williams)), which is approximately 10% of the known number
of inmates with chronic HCV. (Id.)
least 109 inmates have died from complications of HCV in TDOC
custody since 2009, although (1) DAAs have only been
available for part of that time and (2) DAAs would not
necessarily have changed all of those specific outcomes given
the combination of the long pathology of HCV and the time at
which inmates could have been treated by TDOC. (Doc. No. 251,
Tr. Vol. 2 at 169-170 (Williams)).
is a contagious virus spread through contact with infected
blood or bodily fluids. (Doc. No. 198, Tr. Stip. No. 1.)
HCV virus travels to and infects the liver, the largest organ
in the body, causing an inflammatory process referred to as
HCV infection occurs in two stages: acute and chronic. (Doc.
No. 251, Tr. Vol. 2 at 16 (Yao)).
the first approximately six months following initial HCV
infection, persons are in the “acute” phase.
(Doc. No. 198, Tr. Stip. No. 2; Doc. No. 251, Tr. Vol. 2 at
During the acute HCV stage, approximately 15 to 25% of
patients will spontaneously clear or resolve. (Doc. No. 198,
Tr. Stip. No. 3.)
the majority of patients, however, HCV infections do not
spontaneously resolve and result in chronic HCV infection.
(Id., Tr. Stip. No. 4.)
Chronic HCV is a serious health condition that requires
medical attention. (Doc. No. 234 at 16-17 (pretrial conf.
stip.); Doc. No. 251, Tr. Vol. 2 at 9-14 (Yao)).
Chronic HCV is a progressive disease. Specifically, chronic
HCV damages the liver by causing progressive scarring of the
liver, known as fibrosis. A five-point score is used for
measuring the degree of fibrosis: F0 (no fibrosis), F1 (mild
fibrosis), F2 (moderate fibrosis), F3 (advanced fibrosis),
and F4 (cirrhosis). Doc. No. 251, Tr. Vol. 2 at 33 (Yao)).
Chronic HCV also affects other organs in the human body.
(Id. at 9-10). Beginning as early as the acute stage
and continuing through the chronic stage, HCV patients may
experience fatigue, jaundice, nausea, and pain. (Id.
at 10.) In advanced stages, HCV patients may experience
vasculitis, skin lesions, kidney, heart, and cognitive
symptoms. (Id. at 11.) The rate of fibrosis
progression is not the same in all HCV patients. (Doc. No.
198, Tr. Stip. Nos. 5-6; Doc. No. 251, Tr. Vol. 2 at 259
(Williams)). The FibroSure score (a combination of age,
platelet count, and blood tests) and AST to Platelet Ratio
Index (“APRI”) are non-invasive methods used to
determine a patient's fibrosis stage. (Doc. No. 251, Tr.
Vol. 2 at 14 (Yao)). These methods fail to detect severe
liver fibrosis a significant percent of the time.
(Id.) The FibroScan is a non-invasive, more accurate
method of determining a patient's fibrosis stage
utilizing sound waves to measure liver stiffness.
(Id. at 15; Def. Ex. 2.)
Cirrhosis is the late stage (F4) of liver scarring caused by
chronic HCV. There are two types of cirrhosis: compensated
cirrhosis, which is asymptomatic (i.e., adequate liver
function), and decompensated cirrhosis, which is symptomatic
(i.e., inadequate liver function). (Doc. No. 198, Tr. Stip.
No. 7.) During decompensated cirrhosis, the liver has
deteriorated such that it cannot support the other organs
required for the body to function. (Doc. No. 251, Tr. Vol. 2
at 13 (Yao)). Individuals with cirrhosis are also at risk of
developing primary liver cancer (i.e., hepatocellular
cancer). (Doc. No. 198, Tr. Stip. No. 7.) The occurrence of
either decompensated cirrhosis or liver cancer is referred to
as end-stage liver disease. (Id.)
Chronic HCV symptoms can vary and are not dependent on a
patient's fibrosis or cirrhosis stage. For example, some
patients may have very severe symptoms, but only have mild
liver fibrosis, while others may progress to liver cirrhosis
but, if compensated, may have normal liver function. (Doc.
No. 251, Tr. Vol. 2 at 12 (Yao)).
Chronic HCV is a major cause of liver failure. (Id.
at 13). When the liver is failing, it cannot process toxins,
raising the body's ammonia level and hepatoencephalopathy
with attendant mental impairment. (Id. at 12-13.)
Chronic HCV is also the number one reason for liver
transplantation in the United States. (Id. at 13.)
Approximately 20 to 40 percent of chronic HCV patients will
progress to F4 cirrhosis and approximately 4% will develop
liver cancer. (Id. at 10, 97.)
those patients who progress to decompensated liver cirrhosis,
the liver will ultimately fail and be unable to support the
body. (Id. at 36-37.)
There is no vaccine for HCV. (Id. at 39.)
Diagnosis of HCV starts with an antibody screening by means
of a blood test. (Id. at 13-14.) If that is
positive, a second blood test is conducted for HCV-RNA
(ribonucleic acid) to determine whether the virus is active.
the past, the standard treatment for chronic HCV infections
involved injections of a drug called interferon, which
activates the immune system. However, the interferon
treatment process was long, resulted in lower success rates,
and caused severe side effects. (Doc. No. 198, Tr. Stip. No.
2011, the U.S. Food and Drug Administration
(“FDA”) approved DAAs to treat HCV.
(Id., Tr. Stip. No. 9.) DAAs are taken in pill form
once a day and have minimal side effects. (Doc. No. 251, Tr.
Vol. 2 at 9-10, 19-21 (Yao)). Upon the approval of DAAs,
interferon treatment for HCV was effectively
abandoned. (Id. at 21.)
There are several different genetic types of HCV, known as
“genotypes” (e.g., genotype 1, genotype 2, etc.).
(Id. at 15.) DAAs are now available for treatment of
all known HCV genotypes (i.e., “pan-genotype”
DAAs). (Id. at 21.)
aim of DAAs is to remove detectable HCV-RNA from blood serum.
(Id. at 22.) The absence of HCV-RNA after 12 weeks
is known as sustained virologic response (“SVR”),
or a “virologic cure.” (Id.)
SVR, also known as a “surrogate outcome, ” is a
“marker” of the end goal of HCV treatment, which
is preventing end-stage liver disease and HCV-related
mortality. (Id. at 87-88.) The FDA, NIH, and
AASLD/IDSA use SVR as the marker for the success of DAA
treatment. (Id. at 88.)
things being equal, the HCV virus rarely reappears after SVR.
(Id. at 22-23.)
proceed with DAA treatment, a physician needs limited
information: (Id. at 14-16) a face-to-face physical
examination to evaluate symptoms, (Id. at 44-45) and
confirmation that a patient has active HCV-RNA and is chronic
(i.e., has had the infection for six months or more).
(Id. at 16.) Because of the effectiveness of DAAs, a
fibrosis score is less important to treatment or management
significant decision is whether DAA treatment is needed for 8
weeks or 12 weeks. (Id. at 16-17.)
“Standard of Care” for HCV
Zhiqiang Yao presented his expert opinion regarding the
“standard of care” for treating chronic HCV. Dr.
Yao, M.D., PhD., is a Distinguished Professor at East
Tennessee State University, Quillen College of Medicine and
Director of the hepatitis program at the James H. Quillen
Veterans' Administration (“VA”) Medical
Center. He specializes in the treatment of HCV, is
board-certified in both internal medicine and infectious
diseases, and is a member of the American Association for the
Study of Liver Diseases (“AASLD”) and the
Infectious Diseases Society of America (“IDSA”).
In addition to conducting prolific research, Dr. Yao oversees
the treatment of 3, 000 to 4, 000 HCV patients each year.
(Id. at 5-9.) The Court finds Dr. Yao highly
knowledgeable and credible on the subjects of HCV and its
treatment. He explained that the “standard of
care” means the “best practice” physicians
should follow. (Id. at 121.)
According to Dr. Yao, because early treatment of chronic HCV
stops the progression of the damage to patient's liver
and prevents damage to other organs, there is no reason to
not treat mildly symptomatic patients. (Id. at 29,
Yao believes that the standard of care or best practice,
requires a physician to wait six months for the acute phase
to spontaneously clear the HCV infection. If it does not, the
physician should treat the patient with DAAs “as early
as possible” (id. at 21, 103, 107, 121), or
“in a timely manner” (Pl. Ex. 8 at 8-10 (Yao
Rep.) (emphasis added); P. Ex. 9 at 2 (Yao Supp. Rep.)
(emphasis added)), regardless of fibrosis stage. He does not
believe that there is any basis for prioritizing care
“for only stage F4 and F3 patients.”
(Id. (emphasis added)). Delaying care, in Dr.
Yao's opinion, may have “adverse effects.”
(P. Ex. 8 at 11 (Yao Rep.))
AASLD, the professional organization primarily comprised of
gastroenterologists and hepatologists; the IDSA, the
professional organization primarily comprised of infectious
disease specialists; the Centers for Disease Control, the
National Institute for Health (“NIH”), the
Veteran Administration (“VA”), Medicare, state
Medicaid programs, and multiple private insurance companies
agree that immediate treatment of DAA's is the standard
of care for chronic HCV. (Doc. No. 251, Tr. Vol. 2 at 26-27
AASLD/IDSA panel has published the “Recommendations for
Testing, Managing, and Treating Hepatitis C”
(“AASLD/IDSA Guideline”) since 2014. (P. Ex. 8.)
The AASLD/IDSA Guideline contains treatment
“recommendations.” (Id.) Since 2015, the
AASLD/IDSA Guideline has stated that evidence supports DAA
treatment for all HCV patients regardless of their liver
fibrosis stage (except those with short life expectancies
that cannot be remediated by treating HCV or by other
directed therapy). (Doc. No. 251, Tr. Vol. 2 at 27-28 (Yao)).
majority of medical providers in the United States who treat
HCV follow the AASLD/IDSA Guidance recommendations.
(Id. at 101-102.)
TDOC called two experts regarding the HCV standard of care.
Dr. Martha S. Gerrity is a Professor of Medicine in the
Department of Medicine Division of General Medicine at Oregon
Health and Sciences University who also works at the Portland
VA and the Scientific Resource Center for the Agency for
Healthcare Research. (Doc. No. 252, Tr. Vol. 3 at 184-185
(Gerrity)). She is board certified in internal medicine and
is an academic general internist with training in clinical
epidemiology, clinical research methods and education.
(Id. at 184-186.) She is not a gastroenterologist,
infectious disease specialist, hepatologist, expert in the
field of HCV, or HCV researcher, and she has never prescribed
DAAs. (Doc. No. 252, Tr. Vol. 3 at 219-220 (Gerrity).) Dr.
Ronald Koretz is an emeritus professor of clinical medicine
at the David Geffen UCLA School of Medicine and former
gastroenterologist at the Olive View UCLA Medical Center in
Los Angeles County, California. (Doc. No. 253, Tr. Vol. 4 at
5-7 (Koretz).) He is board-certified in internal medicine and
gastroenterology, which includes general familiarity with
treatment of liver disease. (Id. at 7.) However, he
is neither an infectious disease specialist nor a
hepatologist, and has never prescribed DAAs. (Id. at
Gerrity offered an opinion criticizing the trustworthiness
and methodology of the AASLD/IDSA Guideline. She opined that
it is of poor methodological quality and untrustworthy
because its authors did not take a systematic approach to
make it sufficiently evidence-based. (Doc. No. 252, Tr. Vol.
3 at 184-216 (Gerrity)). The Court finds Dr. Gerrity's
opinion weak. Specifically, based on her demeanor at trial
she appears to be advocating a personal cause. She did not
offer any convincing explanation regarding why she does not
accept the AASLD/IDSA Guideline, that has been accepted by
the general scientific community. Her testimony was also
evasive. For example, when asked if she knew about the
National Institutes of Health adherence to the AASLD/IDSA
Guideline, Dr. Gerrity responded, “I'm not sure
what institute you're describing.” (Id. at
230.) She was curiously unfamiliar with the positions of
Medicare/Medicaid and World Health Organization, even though
she recently prepared an academic report on the AASLD/IDSA
Guideline at the request of state Medicaid directors because
it was a “very important issue” to them.
(Id. at 203-204, 230.) Dr. Gerrity did not provide a
sufficiently credible explanation of her opinion, failed to
sufficiently discredit Dr. Yao's opinion, and appeared to
be advancing a personal, albeit academically-based, agenda.
Court also rejects Dr. Gerrity's opinion because of a
conflict of interest. Upon direct examination, Dr. Gerrity
led the Court to believe that she was not compensated for her
work on this case and attended the trial on her personal
vacation. (Id. at 186.) She attempted to lead the
Court to believe she was testifying free of any bias and only
due to the strength of her beliefs. However, on
cross-examination it was revealed that Dr. Gerrity is
employed by the Center for Evidence-Based Policy, which
encompasses the Medicaid Evidence-Based Decision Project.
(Id. at 185, 221, 236.) The State of Tennessee is a
member of this group and pays a fee of approximately $120,
000 to $150, 000 per year that goes, in part, directly to pay
Dr. Gerrity's salary. (Id. at 185, 221, 236.)
The Court disapproves of her gross lack of candor.
Koretz offered a similar opinion regarding the lack of
evidence supporting the AASLD/IDSA Guideline, as well as what
he believes to be a lack of proof that DAA treatment actually
affects the clinical outcomes of HCV patients. (Doc. No. 253,
Tr. Vol. 4. at 12-63 (Koretz)). The Court also declines to
credit Dr. Koretz's opinion. His demeanor and tone
reflected deeply held extreme personal opinions that affected
his conclusions. He rejects the use of SVR as a marker of HCV
treatment success. He overenthusiastically believes that
there is “no evidence that [DAA] treatment is
beneficial for anybody.” (Id. at 70-71.) Not
only is there no support in the record for these extreme
positions, they are directly contradicted by established
medicine. The FDA has approved DAAs, and DAAs are accepted,
used, and considered successful by the medical community in
treating HCV. Dr. Yao testified that he has a 100% SVR (i.e.,
virologic cure rate) in his HCV practice after DAA
administration. Even TDOC's own Medical Director and
Associate Medical Director consider DAAs to be a cure for
chronic HCV measured by SVR. (Id. at 91-92.) The
Court finds that, on balance, Dr. Koretz's personal
beliefs have clouded his judgment and call into question his
TDOC's HCV ...