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Pevia v. Wexford Health Source, Inc.

United States District Court, D. Maryland

February 20, 2018

DONALD R. PEVIA, Plaintiff
WEXFORD HEALTH SOURCE, INC., et al., Defendants DONALD R. PEVIA, Plaintiff


          Ellen L. Hollander United States District Judge

         This 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.

         In Case 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 dispositive motions.

         In Pevia I, the Medical Defendants have moved to dismiss or, in the alternative, for summary judgment. ECF 18.[1]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.

         In 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.

         No 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.

         I. Factual Background

         A. Pevia I

         In 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 2.[2]
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 addressed. Id.
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.

         B. Pevia II

         Plaintiff 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 2013[3]he 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, [4] 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.

         C. Department of Public Safety and Correctional Services Protocol For Treatment of HCV

         1. Development of Protocol

         Defendants 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)[5]; 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, 4/18/17).

         Since 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.

         The 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.

         In 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.

         In 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, ¶ 4.

         Antiviral 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, ¶ 14.

         The 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.

         Further, 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.

         The 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.

         The 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.

         Policies 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 effective. Id.

         Dr. 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.

         Exceptions 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.

         Further, 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.

         The 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.

         Inmates 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.

         The 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, ¶ 7.

         According 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.

         Dr. 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., ΒΆ 8. Dr. Baucom confirms that at the time relevant to plaintiff's Complaint, Pegylated ...

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