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Atkins v. Parker

United States District Court, M.D. Tennessee, Nashville Division

September 30, 2019

GREGORY ATKINS, et al., on behalf of themselves and all others similarly situated, Plaintiffs,
v.
TONY C. PARKER and DR. KENNETH WILLIAMS, Defendants.

          FINDINGS OF FACT AND CONCLUSIONS OF LAW

          WAVERLY D. CRENSHAW, JR. CHIEF UNITED STATES DISTRICT JUDGE.

         This 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.

         The 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.

         The Court enters the following Findings of Fact and Conclusions of Law in accordance with Rule 52(a) of the Federal Rules of Civil Procedure.[1]

         FINDINGS OF FACT

         I. The Class and Claim

         1. 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.)

         2. 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.)

         3. There are approximately 21, 000 inmates in TDOC custody. (Doc. No. 198, Tr. Stip. No. 20.)

         4. At the time of trial, there were approximately 4, 740 inmates known to be infected with chronic HCV. (Id., Trial Stip. No. 21.)

         5. The 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)).

         6. As 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.)

         7. At 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)).

         II. HCV

         A. Background

         8. HCV is a contagious virus spread through contact with infected blood or bodily fluids. (Doc. No. 198, Tr. Stip. No. 1.)

         9. The HCV virus travels to and infects the liver, the largest organ in the body, causing an inflammatory process referred to as “hepatitis.” (Id.)

         10. An HCV infection occurs in two stages: acute and chronic. (Doc. No. 251, Tr. Vol. 2 at 16 (Yao)).

         11. For 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 9-10 (Yao)).

         12. During the acute HCV stage, approximately 15 to 25% of patients will spontaneously clear or resolve. (Doc. No. 198, Tr. Stip. No. 3.)

         13. For the majority of patients, however, HCV infections do not spontaneously resolve and result in chronic HCV infection. (Id., Tr. Stip. No. 4.)

         14. 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)).

         15. 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.)

         16. 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.)

         17. 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)).

         18. 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.)

         19. 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.)

         20. For those patients who progress to decompensated liver cirrhosis, the liver will ultimately fail and be unable to support the body. (Id. at 36-37.)

         B. Treating HCV

         21. There is no vaccine for HCV. (Id. at 39.)

         22. 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. (Id.)

         23. In 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. 8.)

         24. In 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.[2] (Id. at 21.)

         25. 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.)

         26. The 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.)

         27. 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.)

         28. All things being equal, the HCV virus rarely reappears after SVR. (Id. at 22-23.)

         29. To 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 decision. (Id.)

         30. The significant decision is whether DAA treatment is needed for 8 weeks or 12 weeks. (Id. at 16-17.)

         C. “Standard of Care” for HCV

         31. Dr. 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.)

         32. 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, 102.)

         33. Dr. 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.))

         34. The 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 (Yao)).

         35. An 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)).

         36. A majority of medical providers in the United States who treat HCV follow the AASLD/IDSA Guidance recommendations. (Id. at 101-102.)

         37. 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 63-67.)

         38. Dr. 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.

         39. The 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.

         40. Dr. 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 entire analysis.

         III. TDOC's HCV ...


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