Atkins v. Parker
| Decision Date | 24 August 2020 |
| Docket Number | No. 19-6243,19-6243 |
| Citation | 972 F.3d 734 |
| Parties | Gregory ATKINS, Christopher Gooch, Kevin Proffitt, and Thomas Rollins, Jr., on behalf of themselves and all others similarly situated, Plaintiffs-Appellants, v. Tony PARKER, Commissioner, Tennessee Department of Corrections, and Dr. Kenneth Williams, Medical Director, Tennessee Department of Corrections, in their official capacities, Defendants-Appellees. |
| Court | U.S. Court of Appeals — Sixth Circuit |
Gregory Atkins and his fellow plaintiffs represent a certified class made up of Tennessee prisoners suffering from hepatitis C. In 2016, they sued several officials in the state Department of Corrections, including its medical director, Dr. Kenneth Williams, alleging that the officials acted with deliberate indifference to the class's serious medical needs in violation of the Eighth Amendment's prohibition on cruel and unusual punishment. After a four-day bench trial, the court rejected the class's claim. We affirm.
Hepatitis C is a contagious virus that spreads through contact with bodily fluids. The virus causes liver damage that over time diminishes the liver's ability to remove toxins from the body. In some cases, the virus can lead to cirrhosis of the liver, liver cancer, and ultimately even death.
Hepatitis C is a progressive virus, meaning that the disease's effects worsen over time. In the first six months after initial infection, somewhere between 15 and 25 percent of infected persons spontaneously recover. For those who do not recover, the virus proceeds to the "chronic" stage, during which the virus progressively scars the liver. The rate at which the virus causes scarring differs from person to person. Some people might not have serious scarring for 20 to 30 years, if at all; for others, scarring happens more quickly. The most common symptoms of the disease—which range from minor (fatigue, jaundice, nausea) to major (severe inflammation, skin lesions, cognitive impairment)—are not necessarily tied to the extent of liver scarring an infected person has suffered. Between 20 and 40 percent of persons who reach the chronic stage eventually develop cirrhosis ; four percent develop liver cancer.
There is no vaccine for hepatitis C. In the past, doctors treated the virus by injecting infected patients with drugs known as interferons, but that treatment brought little success and severe side effects. In 2011, the FDA approved a new class of drugs—known as direct-acting antivirals—that are superior to interferons in nearly every respect. Notably, for almost all patients who take them, direct-acting antivirals halt the progress of hepatitis C and eventually cause the virus to disappear completely. The antivirals are so effective that for the most part doctors have stopped using interferons entirely.
But that efficacy comes at a price. In 2015, the cost of a single course of treatment using direct-acting antivirals was between $80,000 and $189,000. By the time of trial, those prices had dropped to between $13,000 and $32,000 per course of treatment.
In 2016, the efficacy—and cost—of direct-acting antivirals prompted the Department of Corrections to implement a treatment policy for hepatitis-C infected inmates. Specifically, the 2016 policy specified that the Department would provide the antivirals only to infected inmates with severe liver scarring. The policy provided no pathway to antivirals for inmates with less-advanced scarring, even if those inmates presented exceptionally worthy cases.
By 2019, approximately 4,740 of the 21,000 inmates in Tennessee's prisons had hepatitis C. The virus's prevalence, along with the declining cost of direct-acting antivirals, prompted the Department to update its guidance for the "evaluation, staging, tracking, and other treatment of patients" with hepatitis C. The Department's medical director, Dr. Williams, developed and oversaw the implementation of this new guidance, which applied to all hepatitis-C infected inmates in the state's prisons.
Under the 2019 guidance, every new inmate, with few exceptions, is tested for hepatitis C. Inmates who test positive must then undergo a baseline evaluation, which includes a physical exam focused on the symptoms of liver disease, a medical-history check, a series of laboratory tests, a preventive-health assessment, and a battery of tests to measure the extent of the inmate's liver scarring.
The 2019 guidance also requires an advisory committee to evaluate each infected inmate and to determine his course of treatment. Among other things, the guidance establishes criteria that make antivirals available to "individuals [who] are at higher risk for complications or disease progression and may require more urgent consideration for treatment." Those criteria, which align with guidance promulgated by the Federal Bureau of Prisons, favor the sickest inmates—those with the most advanced scarring or other medical conditions that might accelerate their symptoms—for access to direct-acting antivirals. But the guidance also provides that the Ultimately, whether an infected inmate receives antivirals is up to the advisory committee.
Dr. Williams chairs that committee, which is made up of healthcare professionals, including an infectious-disease specialist and a pharmacist. The committee meets regularly and reviews the records of every infected inmate, regardless of his illness's progress. Because different cases require different courses of treatment, the committee is also responsible for selecting the specific combination of drugs an inmate will receive. Once the committee makes that selection, the inmate's local provider oversees his treatment and provides ongoing care.
The 2019 guidance also includes a "workflow"—a series of procedural steps for local providers—to make standard the administration of hepatitis C treatment across the prison system. To that end, the workflow provides instructions to medical providers for testing, diagnosis, recordkeeping, and follow-up treatment. For local providers, the workflow replaced an ad hoc system with a uniform one; and for the committee, the workflow aimed to speed up the process by which it assessed infected inmates.
Finally, the guidance provides for continuous care and monitoring of infected inmates, regardless of their course of treatment. At a minimum, every six months each infected inmate undergoes reassessment at a "chronic care clinic." The reassessment consists of a physical exam, bloodwork and other laboratory tests, patient-specific hepatitis C counseling, and additional measurement of liver scarring ; inmates with advanced scarring also undergo an ultrasound screening for cancer. The committee then uses these data to determine whether to revise an infected inmate's course of treatment or—in the case of inmates who are not receiving direct-acting antivirals—whether to change their priority level for those drugs.
In 2016, Atkins and his fellow plaintiffs brought this § 1983 suit against several officials in the Department, seeking declaratory and injunctive relief. The plaintiffs alleged that the Department's "prioritization" approach amounted to deliberate indifference to the class's serious medical needs, in violation of the Eighth Amendment. During the course of the litigation, the Department issued its 2019 guidance, and the parties then agreed to focus on that guidance (rather than the 2016 policy) at trial.
In July 2019 the court held a four-day bench trial, during which it heard testimony from experts on both sides, from infected inmates, and from Department officials themselves. The plaintiffs presented a hepatitis C expert, Dr. Zhiqiang Yao, who testified that the "best practice" is to treat chronic hepatitis C with direct-acting antivirals "as early as possible" or "in a timely manner," regardless of the extent of scarring on a patient's liver. In support, Yao cited the American Association for the Study of Liver Diseases' position that immediate treatment with direct-acting antivirals was the "standard of care" for patients with chronic hepatitis C. Yao also testified that the Department's 2019 guidance was "under the standard of care" because it did not explicitly recommend early treatment using antivirals for all patients. Yao nonetheless conceded that the Department's 2019 guidance was a "significant improvement" over the 2016 policy and that the prioritization approach was "understandable" given the Department's limited resources. Yao also admitted that, when working for the Veterans' Administration, he had himself used a prioritization system for delivering care to hepatitis C patients, much like the one in the Department's 2019 guidance. The court found Yao highly credible, going so far as to recommend that the Department "engage [him] to assist" in the Department's hepatitis C protocols in the future.
The court also heard testimony from Williams's experts, and—for good reasons, suffice it to say—found their testimony to be "weak" and characterized by personal agendas and a "gross lack of candor." The court discounted their testimony entirely.
Williams himself testified and explained that that he was the "final authority" for the Department's policies on hepatitis C treatment. Specifically, he said that he wrote the Department's 2019 guidance, which according to him was designed to provide care to the sickest patients first. He also clarified that, unlike the Department's prior policies, the 2019 guidance guaranteed that every infected inmate, regardless of the extent of the inmate's liver scarring, was eligible for (though by no means guaranteed to receive) antiviral treatment.
As for funding, Williams explained that the Department used all the money budgeted for hepatitis C to purchase direct-acting antivirals,...
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