Case 2:15-cv-03333-JP Document 1 Filed 06/12/15 Page 1 of 21

IN THE UNITED STATE DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

SALVATORE CHIMENTI, DANIEL :

LEYVA, DAVID MALDONADO, and all :

others similarly situated,

:

:

Plaintiffs,

:

:

:

PENNSYLVANIA DEPARTMENT

:

CORRECTIONS (DOC); JOHN

:

WETZEL, Secretary of the (DOC);

:

PAUL NOEL, Chief Medical Director, :

Pennsylvania DOC; CHRISTOPHER :

OPPMAN, Director, Bureau of Health :

Care Services, DOC; DR. KEPHART, :

Medical Director at SCI Smithfield, DOC;:

WILLIAM DREIBELBIS, Correctional :

Health Care Administrator, SCI

:

Smithfield, DOC; DR. WEINER,

:

Medical Director, SCI Graterford;

:

JOSEPH C. KORSZNIAK, Correctional :

Health Care Administrator,

:

SCI Graterford; CORRECT CARE

:

SOLUTIONS (CCS); DR. NICHOLAS :

SCHARFF, Medical Director, CCS;

:

ANDREW DANCHA, Regional Medical :

Director, CCS; DR. JOHN HOCHBERG, :

Assistant Medical Director, CCS;

:

WEXFORD HEALTH SOURCES, INC.; :

DR. THOMAS LEHMAN, Medical

:

Director, Wexford Health Source, Inc. :

Civil No.

Defendants.

CLASS ACTION COMPLAINT

INTRODUCTION

1. The Pennsylvania Department of Corrections (DOC), by policy and practice,

systemically denies necessary medical care for inmates diagnosed with Hepatitis C viral

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infections, thereby placing them at substantial and unnecessary risk for severe illness, injury and death. Plaintiffs bring this action on behalf of themselves and a class of similarly-situated plaintiffs, pursuant to 42 U.S.C. § 1983 and state laws against the DOC, prison officials, and medical providers for depriving them of their rights guaranteed by the Eighth Amendment of the United States Constitution and Article I, § 13 of the Pennsylvania Constitution.
2. Plaintiffs Salvatore Chimenti, Daniel Leyva, and David Maldonado are incarcerated in the Pennsylvania Department of Corrections with serious health complications stemming from their Hepatitis C viral infection. The DOC and other Defendants have refused to provide medical treatment to Plaintiffs and others incarcerated in the DOC with Hepatitis C infections that is consistent with current and prevailing medical standards, as reflected in recommendations from the Center for Disease Control and Prevention (CDC) and public and private medical providers including the Federal Bureau of Prisons (BOP). As a result, the DOC and other Defendants have denied Plaintiffs and others similarly situated access to necessary and proper medical care in violation of the Eighth Amendment and state law.
JURISDICTION AND VENUE 3. Plaintiff brings this action pursuant to 42 U.S.C. § 1983 and the Eighth Amendment of the United States Constitution, and 28 U.S.C. §§ 1331 and 1343. The Court has supplemental jurisdiction under 28 U.S.C 1367(a) to adjudicate the Pennsylvania state law and constitutional claims. 4. Venue is appropriate in this district pursuant to 28 U.S.C. 1391(g) since substantial events at issue in this litigation occurred in the Eastern District of Pennsylvania.
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PARTIES 5. Plaintiff Salvatore Chimenti is an adult individual currently incarcerated at the Pennsylvania State Correctional Institution at Smithfield (SCI Smithfield). Mr. Chimenti sues for injunctive and declaratory relief on behalf of himself and on behalf of a class of plaintiffs who are currently or will in the future be subject to Defendant DOC’s discriminatory and unconstitutional policy for treating Hepatitis C infections. 6. Plaintiff Daniel Leyva is an adult individual currently incarcerated at the State Correctional Institution at Retreat (SCI Retreat). He sues for injunctive and declaratory relief on behalf of himself and on behalf of a class of plaintiffs who are currently or will in the future be subject to Defendant DOC’s discriminatory and unconstitutional policy for treating Hepatitis C infections. 7. Plaintiff David Maldonado is an adult individual currently incarcerated at the State Correctional Institution at Graterford (SCI Graterford). He sues for injunctive and declaratory relief on behalf of himself and on behalf of a class of plaintiffs who are currently or will in the future be subject to Defendant DOC’s discriminatory and unconstitutional policy for treating Hepatitis C infections. 8. Defendant Pennsylvania Department of Corrections (DOC) is an agency of the Commonwealth of Pennsylvania that operates SCI Smithfield, SCI Retreat, and SCI Graterford, among other correctional institutions. The principal office for the DOC is located in Mechanicsburg, Pennsylvania. The DOC is responsible for providing adequate medical health services to and creating policies that ensure appropriate medical treatment to Plaintiffs and those similarly situated.
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9. Defendant John Wetzel is the Secretary of the DOC. He is responsible for all the oversight, operation, and administration of the Commonwealth’s correctional system, including providing appropriate medical treatment and the formulation of policies that ensure the provision of that treatment to Plaintiffs and those similarly situated. He is sued in his official and individual capacities. At all relevant times, Defendant Wetzel has acted and will continue to act under color of state law.
10. On information and belief, Defendant Paul Noel is the Chief Medical Director of the DOC and has responsibility in overseeing the delivery of medical services in the DOC. Defendant Noel is sued in his individual and official capacities. He has acted and will continue to act under color of state law.
11. Defendant Christopher H. Oppman is the Director of the Bureau of Health Care Service of the DOC. The Bureau of Health Care Services is responsible for supervising and monitoring the delivery of all medical and dental care services throughout the state correctional system, which must be provided at a level consistent with community standards. Defendant Oppman is sued in his individual and official capacities. At all relevant times, he has acted and will continue to act under color of state law.
12. Defendant Kephart is the Medical Director at SCI Smithfield and is responsible for providing health care to inmates there, and an employee of Correct Care Solutions and/or Wexford Health. He is sued in his official and individual capacities. At all relevant times, Defendant Kephart has acted and will continue to act under color of state law.
13. Defendant William Dreibelbis is a Correctional Health Care Administrator (CHCA) at SCI Smithfield, and an employee of the Department of Corrections. As CHCA, he is responsible for the oversight of health care at SCI Smithfield. Defendant Dreibelbis is sued in his
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official and individual capacities. At all relevant times, he has acted and will continue to act under color of state law.
14. Defendant Dr. Weiner is the Medical Director at SCI Graterford and is responsible for providing health care to inmates there and an employee of Correct Care Solutions and/or Wexford Health. He is sued in his official and individual capacities. At all relevant times, Defendant Weiner has acted and will continue to act under color of state law.
15. Defendant Joseph C. Korszniak is a Correctional Health Care Administrator (CHCA) at SCI Graterford and an employee of the Department of Corrections. As CHCA, he is responsible for the oversight of health care at SCI Graterford. Defendant Korszniak is sued in his official and individual capacities. At all relevant times, he has acted and will continue to act under color of state law.
16. Defendant Correct Care Solutions is the current health care provider for all DOC facilities. The principal office for Correct Care Solutions is in Nashville, Tennessee, and, on information and belief, maintains an office in Pennsylvania. Correct Care Solutions began providing health care services to the Pennsylvania DOC on September 1, 2014. At all relevant time, Correct Care Solutions has acted and will act under the color of state law.
17. On information and belief, Dr. Nicholas Scharff is the Medical Director for Correct Care Solutions in Pennsylvania, and in that capacity is responsible for providing adequate medical care of Plaintiffs and those similarly situated. Defendant Scharff is sued in his individual and official capacity, and at all relevant times has acted and will continue to act under color of state law.
18. On information and belief, Defendant Andrew Dancha is the Regional Medical Director for Correct Care Solutions, and is responsible for overseeing the delivery of medical
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services in DOC through Correct Care Solution’s Central Region, including SCI Smithfield. Defendant Dancha is sued in his individual and official capacities, and at all relevant times has acted and will continue to act under color of state law.
19. On information and belief, Defendant John Hochberg is the Assistant Medical Director for Correct Care Solutions’ Regional Office, and is responsible for overseeing the delivery of medical services in DOC through Correct Care Solution’s Central Region, including SCI Smithfield. Defendant Hochberg is sued in his individual and official capacities, and at all relevant times has acted and will continue to act under color of state law.
20. Defendant Wexford Health Sources Inc. was the previous health care provider for all DOC facilities. The principal office for Wexford Health Sources is in Pittsburgh, Pennsylvania. At all relevant time, Defendant Wexford Health Sources has acted and will act under the color of state law.
21. Upon information and belief, Dr. Thomas Lehman was the Medical Director of Wexford Health Source. He is sued in his individual capacity. At all relevant time, Defendant Lehman has acted and will act under the color of state law.
FACTS The Hepatitis C Epidemic
22. Hepatitis C is a viral infection, primarily spread through contact with infected blood that attacks the liver and causes hepatitis, or liver inflammation, which can significantly impair the liver’s ability to assist the body in digesting essential nutrients, filter toxins from the blood, and prevent disease.
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23. Hepatitis C infections are of multiple genotypes and can be of an acute or chronic nature. An acute infection, a short-term illness, occurs within the first six (6) months of exposure to the virus and, for many people, it leads to chronic Hepatitis C infection.
24. Chronic Hepatitis C infections are serious, long-term illnesses that can last throughout a person’s life. Hepatitis C is the leading cause of cirrhosis (irreversible scarring of liver tissue) and liver cancer and is the most common cause of liver transplants. Chronic Hepatitis C infection can also cause serious chronic liver disease, liver fibrosis (scarring of liver tissue), and death.
25. Cirrhosis of the liver can cause symptoms such as swelling, increased likelihood of bruising, jaundice, itching, nausea, and problems with concentration and memory.
26. Hepatitis C infections occur upon transmission of blood from a person infected with Hepatitis C to another person. The major means of transmission are the sharing of equipment for injecting drugs; tattooing or piercing; through needle-stick injuries; being born to a mother with Hepatitis C; transfusion with infected blood or blood products; and by sexual contact with a person infected with Hepatitis C.
27. Each day without treatment increases the likelihood of cirrhosis, fibrosis, liver cancer, the need for a liver transplant, complications from the disease, death from liver failure due to chronic Hepatitis C infection, and the risk of transmitting Hepatitis C to others.
28. Liver transplants are painful, carry a risk of significant complications, and are nearly impossible for prisoners to obtain. Transplants result in lower recovery rates than treatment with direct-acting antiviral drugs, and transplants are very costly.
29. By not providing necessary medical care, Defendants’ action threaten Plaintiffs and those similarly situated with death and other irreparable harm stemming from their Hepatitis
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C infections. Plaintifsf and members of the proposed class have suffered and will continue to suffer grave and irreparable harm unless the Court orders Defendants to provide the safe and effective treatment with direct-acting antiviral drugs as described below.
30. On information and belief, about 20 percent of inmates under the supervision of the DOC are currently infected with Hepatitis C.
31. The CDC recommends that persons with an increased risk for Hepatitis C infection be tested. This includes, but is not limited to, persons born from 1945-1965; persons who have injected illegal drugs; persons who received blood, blood products, or transplants before 1992; persons with an HIV infection; persons born to a positive mother infected with hepatitis C; and any persons with known exposure to the virus. Standard of Care for Hepatitis C Infections
32. For many years, finding and establishing an effective and safe treatment for Hepatitis C infections was a highly elusive goal. The standard treatment, which included the use of interferon and ribavirin medications, failed to cure large numbers of patients and was associated with painful and other adverse side-effects, including psychiatric and autoimmune disorders, flulike symptoms, and gastrointestinal distress.
33. Over the past three years, the approval by the Federal Drug Administration (FDA) of new direct-acting antiviral drugs (DAAD) has greatly improved the treatment module for Hepatitis C infections.
34. In 2011, the FDA approved the use of protease inhibitors called boceprevir (under brand name Vicrtrelis) and telaprevir (under brand name Incivek), and the standard of care developed into a “triple therapy” to include the combination of either boceprevir or telaprevir, plus ribavirin and interferon. The triple therapy improved results for many patients, but
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continued to produce painful and adverse side effects, and the treatment duration could take 48 weeks to complete.
35. In 2013, the FDA approved DAAD medications called simeprevir (under brand name Olysio) and sofosbuvir (under brand names Sovaldi). At this time, the recommended treatment was DAAD such as Solvadi combined with ribavirin, or with interferon, depending on the patient’s other symptoms and medical diagnoses.
36. In late 2014, the FDA approved the use of Sovaldi in combination with Olsyio for the treatment of Hepatitis C.
37. On October 10, 2014, the FDA specifically approved Harvoni, a pill that is taken once a day and combines sofosbuvir and ledipasvir.
38. Harvoni eliminates the need for the patient to take interferon and/or ribavirin, which were largely responsible for the adverse and difficult side-effects of treating Hepatitis C.
39. Solvaldi (sofosbuvir), Olysio (simeprevir), and Harvoni have few side effects, greater efficacy, can reduce treatment durations by 75 percent, and are administered orally rather than by injections.
40. The new treatment modules utilizing these newest DAAD have very high cure rates (over 90% of patients treated for Solvaldi and over 95% for Harvoni), have fewer and far less serious side-effects than the previous treatment modules, and involve a far shorter treatment time (12-24 weeks).
41. The standard of care in the community for Hepatitis C infections—the use of the latest DAAD—is now well-established. The CDC has recommended these new treatment modules and the Federal Bureau of Prisons (BOP), in 2014, adopted new Clinical Practice Guidelines that incorporate these new DAAD treatment modules. Under the CDC and the BOP
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guidelines, the recommended treatment depends further upon the particularized genotype, the acute or chronic status of the disease, and prior attempts to treat the patient’s Hepatitis C infection.
42. On information and belief, correctional systems in California, Illinois, Washington, Wisconsin, Oregon, and New York have also developed procedures to provide DAADs to individuals that fall within their guidelines, and have started prescribing these lifesaving medications to certain prisoners. Pennsylvania DOC Policy for Hepatitis C Infections
43. Defendants have not implemented treatment policies or provided medical treatment for Hepatitis C infections consistent with current medical and community standards and specifically have not authorized treatment with the effective direct-acting antiviral drugs.
44. Upon information and belief, Defendants have ceased providing any treatment to inmates with Hepatitis C infections, including the combination therapy of interferon and ribavirin, or the triple therapy of boceprevir/telaprevir with interferon and ribavirin.
45. Contrary to the proper and necessary medical procedures and the community standard of care, Defendants have denied requests by Plaintiffs Chimenti, Levya, Maldonado, and by other members of the class for the appropriate and medically necessary direct-acting antiviral treatment for their Hepatitis C infections.
46. The DOC subcontracts its medical care to private medical care companies, but also employs medical care professionals, including correctional health care administrators, at each institution.
47. Upon information and belief, the Bureau of Health Care Services (BHCS) is a bureau within the DOC that provides oversight of medical care services to DOC inmates.
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48. Individuals seeking medical treatment for their Hepatitis C infections have merely been informed that the “DOC/BHCS is revaluating [their] treatment protocol for Hepatitis C given the new guidance issued by the American Association of Liver Diseases (AASLD) and the Infectious Diseases Society of American (IDSA).”
49. In the meanwhile, Plaintiffs and all class members have not received the necessary medical treatment for Hepatitis C, including the latest DAAD such as Solvaldi (sofosbuvir), Olysio (simeprevir) or Harvoni (sofosbuvir with ledipasvir).
50. As a consequence of this policy, Plaintiffs and all class members with Hepatitis C infections have a substantially increased risk of continued Hepatitis C infection, liver disease, liver cancer, cirrhosis, and death.
51. There is no medical justification for a treatment module for Hepatitis C infection that does not utilize the direct-acting antiviral drugs such as simeprevir (Olysio) and sofosbuvir (Solvaldi) or sofosbuvir with ledipasvir (combined as Harvoni). To the extent that the directacting antiviral treatment has not been instituted because of financial considerations, such concerns are unconstitutional and are otherwise in violation of the United States Constitution, the Pennsylvania Constitution, and Pennsylvania state law as they deny necessary and appropriate medical care to Plaintiff and members of the class.
Plaintiff Salvatore Chimenti 52. Mr. Chimenti entered the DOC in 1983, and is currently incarcerated at SCI
Smithfield. 53. In 1991, while Mr. Chimenti was housed at SCI Huntingdon, the medical staff
informed Mr. Chimenti that he had tested positive for Hepatitis C.
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54. Mr. Chimenti received interferon treatments from December 1, 1997 to March 18, 1998, but these treatments did not provide a cure for the disease.
55. In May 1998, a gastrointestinal specialist, Michael F. Gaugler, D.O., recommended consideration of a treatment module for Mr. Chimenti of interferon in combination with ribavirin, and that treatment module was approved by the FDA in or about June 1998.
56. The DOC took 18 months to develop a protocol from 1998 to 2000, and therefore, Mr. Chimenti did not begin the combination treatment with interferon and ribavirin (combined together and branded as Rebetron) until June 2000, but once again his condition did not improve with this six-month treatment.
57. During this time while waiting for the Rebetron treatment for Hepatitis C, Mr. Chimenti’s condition deteriorated from Stage 3 to Stage 4 cirrhosis, thus reducing his chance of responding positively to that treatment by 50 percent.
58. In 2011, after FDA approved a triple therapy treatment using boceprevir or telaprevir in combination with interferon and ribavirin, Mr. Chimenti again sought to have his Hepatitis C treated.
59. After waiting 10 months, Mr. Chimenti was treated with triple therapy at SCI Forest from June 2012 through May 2013. He initially responded positively to the triple therapy, but relapsed six months later in November 2013.
60. Mr. Chimenti now suffers from Stage 4 compensated cirrhosis with chronic liver failure. His Model for End-Stage Liver Disease (“MELD”) score is 12. The MELD score is a measure of mortality risk in patients with end-stage liver disease and is used as a disease severity index to help prioritize allocation of organs for transplant.
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61. In 2009, Dr. Abhinav Humar, Chief Liver Transplant Specialist from the University of Pittsburgh Medical Center was appointed by U.S. District Court Judge Vanaskie to provide a report on Mr. Chimenti’s medical condition. Dr. Humar recommended that Mr. Chimenti be assessed with ultrasounds and CT scans of his liver every six months, and that if Mr. Chimenti’s “MELD” score went above 10, that he be evaluated by a hepatologist for the possibility of a liver transplant.
62. Since November 2013, Defendants, including Dr. Kephart, have denied the necessary treatment to track and halt the deleterious effects of Hepatitis C, including regular ultrasounds and CT scans, which are medically necessary for individuals with Stage 4 cirrhosis.
63. Defendants, including Defendants Dancha, Dreibelbis, Kephart, Correct Care Solutions, Wexford Health Source, and Lehman, failed with deliberate indifference to have Mr. Chimenti seen or evaluated by a hepatologist or a gastroenterologist for proper treatment of his liver condition.
64. In late 2013, Mr. Chimenti began requesting treatment of his Hepatitis C infection with direct-acting antiviral drugs, but he has been denied this treatment by Defendants, even though the standard of community care at that time required that Mr. Chimenti be prescribed Solvadi with ribavirin, which has an over 90% cure rate.
65. In November 2014, CHCA Dreibelbis informed Mr. Chimenti that the “PA DOC has not approved the use of [Harvoni] at this time. Thus it is not offered at this facility.”
66. Despite Mr. Chimenti having stage 4 cirrhosis, the most advanced stage, he has yet to be referred to a hepatologist for a full evaluation since he has been returned to SCI Smithfield.
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67. Mr. Chimenti has fully grieved the denial of his request for this form of medical treatment, as well as the lack of any treatment for his Hepatitis C or cirrhosis.
68. As a result of Defendants’ denial of the necessary medical treatment, Mr. Chimenti continues to suffer from chronic Hepatitis C infection and the related risks of liver failure and death, and physical and emotional pain and suffering.
69. Due to Mr. Chimenti’s advanced cirrhosis and the deterioration of his liver, medical treatment for his Hepatitis C is urgently needed. Once Mr. Chimenti’s liver decompensates, the only treatment for him would be a liver transplant.
70. The refusal, with deliberate indifference, of Defendants to provide Mr. Chimenti and other class members with Hepatitis C infections with access to the necessary and appropriate DAAD and other medical services for the treatment of their Hepatitis C infections constitutes a violation of the Eight Amendment, the Pennsylvania Constitution, and Pennsylvania state law. Plaintiff Daniel Leyva
71. Plaintiff Daniel Leyva is currently incarcerated at SCI Retreat. 72. Mr. Leyva was diagnosed with Hepatitis C in 2001 or 2002 while he was incarcerated at SCI Albion. 73. Previously he had been treated with interferon and ribavirin, but it was unsuccessful in treating his Hepatitis C infection. 74. Mr. Leyva has Hepatitis genotype 1 and recent lab results show that he has elevated or high levels of the Hepatitis C virus. 75. Mr. Leyva requested to be provided the latest direct-acting antiviral drug treatment, but the doctor informed him that it cost too much.
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76. Mr. Leyva filed a grievance requesting to be provided with the latest direct-acting antiviral drug treatment and fully exhausted his administrative remedies.
77. In the DOC response, Joseph Mataloni, Corrections Health Care Administrator at SCI Retreat, wrote, “The DOC is re-evaluating our treatment protocol for Hepatitis C given the new guidance issued by the American Association of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA).”
78. Mr. Leyva also received a response from Christopher H. Oppman, Director, Bureau of Health Care Services, who also informed him that the DOC and BCHS are reevaluating their treatment protocol.
79. Mr. Leyva currently experiences symptoms of Hepatitis C, including pain, fatigue, and his eyes are jaundiced and requires immediate treatment to prevent any further liver damage. Plaintiff David Maldonado
80. Plaintiff David Maldonado has been incarcerated in the DOC since 1980, and has been incarcerated at SCI Graterford since 1995.
81. Mr. Maldonado was diagnosed with Hepatitis C in 1997. 82. Mr. Maldonado was treated with interferon and ribavirin in 2001, but the treatment was unsuccessful. 83. After undergoing a liver biopsy which revealed that Mr. Maldonado was between Stage 1 and Stage 2 liver fibrosis, Mr. Maldonado was transferred to SCI Forest in June 2013 to receive the triple therapy of interferon and ribavirin with boceprevir. While there was some initial success in reducing Mr. Maldonado’s viral load, the treatment failed after six months in December 2013. Mr. Maldonado returned to SCI Graterford in February 2014.
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84. Mr. Maldonado has requested the direct-acting antiviral drug treatment from the medical staff and Medical Director Weiner, but was informed by the Bureau of Health Care Services that a new protocol was being developed.
85. Defendant Korszniak, CHCA at SCI Graterford, responded to Mr. Maldonado’s grievance that, “The drug [Harvoni] that you mention has not yet been approved for use by the DOC, BHCS. When the protols [sic] are extablished [sic] and the drug is approved there will be an assessment done to determine who will qualify for the treatment.”
86. In response to Mr. Maldonado’s appeal of his grievance to the Central Office, he was informed, “The DOC/BHCS is re-evaluating our treatment protocol for Hepatitis C given the new guidance issued by the American Association of Liver Diseases and the Infectious Diseases Society of America.”
87. Mr. Maldonado’s fibrosis requires immediate treatment to prevent any further liver damage or liver failure.
88. Mr. Maldonado filed grievances requesting to be provided proper medical treatment for Hepatitis C, including the latest direct-acting antiviral drug treatment, and has fully exhausted his administrative remedies.
CLASS ACTION ALLEGATIONS 89. Plaintiffs bring this suit as a class action on behalf of himself and all others similarly situated (the “Class”) pursuant to Rules 23(a) and 23(b)(2). 90. Plaintiffs seek to represent the following class on claims for declaratory and injunctive relief:
All persons who are currently incarcerated in a Pennsylvania Department of Corrections facility who have at least twelve (12) weeks or more remaining to serve on their sentences and are either currently diagnosed with Hepatitis C
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infection and/or are determined to have Hepatitis C infection after a blood test administered by the Pennsylvania Department of Corrections.
91. As a result of Defendants’ deliberate indifference to the serious medical needs of the Class, members of the Class are or will be subjected to cruel and unusual punishment and deprived of their federal and state constitutional and statutory rights. Plaintiffs seek declaratory and injunctive relief to remedy Defendants’ illegal and unconstitutional actions, policies, and practices.
92. The requirements of Rules 23(a) and 23(b)(2) are satisfied by this class action. 93. The information as to the size of the Class and the identity of the inmates who are in the Class is in the exclusive control of Defendants. On information and belief, the class encompasses thousands of inmates in the Pennsylvania DOC, who are geographically dispersed throughout the Commonwealth of Pennsylvania. The number of persons who are members of the Class described above are so numerous that joinder of all members in one action is impracticable. 94. Questions of law and fact that are common to the entire Class predominate over individual questions because the actions of Defendants complained of herein were generally applicable to the entire class. These legal and factual questions include, but are not limited to:
a. Whether the treatment regimens utilizing the direct acting antiviral drugs are the proper, necessary and standard course of treatment in the medical community;
b. Whether denial of treatment regimens utilizing the direct-acting antiviral drugs to the Class will cause injury to the Class members, including unnecessary pain and suffering, chronic illness, and death;
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c. Whether Defendants’ Hepatitis C current treatment policy, which denies necessary pharmaceutical treatment for inmates with Hepatitis C infections by following outdated and ineffective treatment regimens or not providing any treatment regimens at all, violates the Eighth Amendment to the U.S. Constitution and Article I § 13 of the Pennsylvania Constitution.
95. Plaintiffs’ claims are typical of the members of the Class because Plaintiffs and all Class Members were injured by the same wrongful policy and practices of Defendants as described in this Complaint. Plaintiffs’ claims arise from the same practices and course of conduct that give rise to the claims of the Class members, and are based on the same legal theories.
96. Plaintiffs will fairly and adequately protect the interests of the Class. Plaintiffs have no interests that are contrary to or in conflict with those of the Class they seek to represent. Plaintiffs are represented by competent and skilled counsel whose interests are fully aligned with the interests of the Class.
97. Relief concerning Plaintiffs’ rights under the laws herein alleged and with respect to the Class would be proper. Defendants have acted or refused to act on grounds generally applicable to the Class, thereby making appropriate final injunctive relief or corresponding declaratory relief with regard to Class Members as a whole and certification of the Class under Rule 23(b)(2) proper.
CLAIMS COUNT I Deprivation of Eighth Amendment Right to Medical Care (against Defendants DOC, Wetzel, Noel, Oppman, Kephart, Dreibelbis, Weiner, Korszniak, Correct Care Solutions, Scharff, Dancha, and Hochberg).
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98. Plaintiffs incorporate paragraphs 1 through 96 of this Complaint as if fully set forth herein.
99. Defendants’ acts and omissions in failing to provide adequate medical care constitute a deliberate indifference to the serious medical needs of prisoners infected with Hepatitis C, thereby establishing a violation of the Eighth Amendment to the United States Constitution.
COUNT II Deprivation of Right Not to Undergo Cruel and Unusual Punishment Under the
Pennsylvania Constitution (against Defendants DOC, Wetzel, Noel, Oppman, Kephart, Dreibelbis, Weiner, Korszniak,
Correct Care Solutions, Scharff, Dancha, and Hochberg). 100. Plaintiffs incorporate paragraphs 1 through 96 of this Complaint as if fully set forth herein. 101. Defendants’ acts and omissions in failing to provide adequate medical care constitute a deliberate indifference to the serious medical needs of prisoners infected with Hepatitis C thereby establishing a violation of Article I, § 13 of the Pennsylvania Constitution and its prohibition against the infliction of cruel punishments.
COUNT III Negligence – Medical Malpractice (against Defendants DOC, Wetzel, Noel, Oppman, Kephart, Dreibelbis, Wexford Health, Lehman, Correct Care Solutions, Scharff, Dancha, and Hochberg). 102. Plaintiff Chimenti incorporates paragraphs 1 through 96 of this Complaint as if fully set herein. 103. At all relevant times, the individual Defendants and corporate Defendants had a duty to act in accordance with the standard of care required of medical care professionals and to act as a reasonable corporation would under the same or similar circumstances, they breached
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that duty in failing to provide the standard of care necessary for individuals infected with Hepatitis C, and Plaintiffs’ injuries were the direct, legal and proximate result of Defendants negligence.

COUNT IV Negligence – Medical Malpractice and Vicarious Liability (against Defendants Wexford Health and Correct Care Solutions) 104. Plaintiff Chimenti incorporates paragraphs 1 through 96 of this Complaint as if fully set herein. 105. Defendants Wexford Health and Correct Care Solutions are vicariously liable for the negligent acts commissions, or omissions of its employees and/or agents, who at all times relevant hereto acted on behalf of defendants Wexford Health and Correct Care Solutions and within the scope of their employment, under the doctrines of respondeat superior and ostensible agency.

RELIEF

WHEREFORE Plaintiffs Salvatore Chimenti, Daniel Leyva, and David

Maldonado respectfully requests the following relief:

106.

For the named plaintiffs and members of the plaintiff Class, a Declaratory

Judgment that Defendant Pennsylvania Department of Corrections current policy for Hepatitis C

treatment violates the Eighth Amendment of the United States Constitution, and Article I § 13 of

the Pennsylvania Constitution;

107.

For the named plaintiffs and members of the plaintiff Class, injunctive relief

ordering that Defendant Pennsylvania Department of Corrections (a) formulate and implement a

Hepatitis C treatment policy that meets the community standards of care for patients with

Hepatitis C, (b) that members of the Class be treated with medically necessary and the

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appropriate direct-acting antiviral drugs based on individual medical testing and medical

evaluation regarding each individual’s Hepatitis C status, and (c) that members of the class

receive ongoing monitoring and medical care per the standard of care for their individual level of

liver fibrosis and cirrhosis, including but not limited to appropriate access to and evaluation by a

hepatologist and assessment regarding their need for partial or full liver transplant.

108.

Compensatory damages for Salvatore Chimenti;

109.

Punitive damages for Salvatore Chimenti;

110.

Reasonable attorneys’ fees and costs; and

111.

Such other relief the Court deems just and equitable.

Date: June 12, 2015

Respectfully submitted,
/s/ David Rudovsky David Rudovsky, PA Attorney No. 15168 Kairys, Rudovsky, Messing & Feinberg LLP 718 Arch Street, Suite 501S Philadelphia, PA 19106 (215) 925-4400
/s/ Su Ming Yeh Su Ming Yeh, PA Attorney No. 95111 Angus R. Love, PA Attorney No. 22392 Pennsylvania Institutional Law Project 718 Arch Street, Suite 304S Philadelphia, PA 19106 (215) 925-2966
/s/ Stephen Brown Stephen Brown, PA Attorney No. 27829 Christine Levin, PA Attorney No. 37807 Ethan Solove, PA Attorney No. 318965 Dechert LLP Cira Centre 2929 Arch Street Philadelphia, PA 19104 (215) 994-2404
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 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

SALVATORE CHIMENTI, ET AL.

:

:

v.

:

:

PENNSYLVANIA DEPARTMENT

:

OF CORRECTIONS, ET AL.

:

CIVIL ACTION NO. 15-3333

MEMORANDUM

Padova, J.

March 21, 2016

Plaintiffs have brought this class action lawsuit against the Pennsylvania Department of

Corrections (the “DOC”), two companies that have contracted to provide medical services for the

DOC, and officials and employees of both the DOC and the two companies, asserting claims

arising from the medical care provided to DOC inmates who have been diagnosed with Hepatitis

C. Before the Court is a Motion to Dismiss brought by the DOC and officials and employees

thereof (the “DOC Defendants”) and a Motion to Dismiss or Sever brought by the medical care

providers and their officials and employees (the “Medical Defendants”). For the following

reasons, each Motion is granted in part and denied in part.

I. FACTUAL BACKGROUND

The Complaint alleges the following facts. Plaintiffs Salvatore Chimenti, Daniel Leyva,

and David Maldonado are all incarcerated in the DOC and all suffer from Hepatitis C viral

infections. (Compl. ¶ 2.) Chimenti is incarcerated at the Pennsylvania State Correctional

Institution at Smithfield (“SCI Smithfield”). (Id. ¶ 5.) Leyva is incarcerated at the Pennsylvania

State Correctional Institution at Retreat (“SCI Retreat”). (Id. ¶ 6.) Maldonado is incarcerated at

the Pennsylvania State Correctional Institution at Graterford (“SCI Graterford”). (Id. ¶ 7.)

Defendant Correct Care Solutions began providing health care services for DOC facilities on

September 1, 2014 and is the current health care provider for all DOC facilities. (Id. ¶ 16.) Defendant Wexford Health Sources, Inc. was the health care provider for all DOC facilities prior to September 1, 2014. (Id. ¶ 20.)
Hepatitis C is primarily spread through the transmission of blood from a person infected with the disease to another person. (Id. 26.) Hepatitis C attacks the liver and causes hepatitis (inflammation of the liver), “which can significantly impair the liver’s ability to assist the body in digesting essential nutrients, filter toxins from the blood, and prevent disease.” (Id. ¶ 22.) Hepatitis C can be acute or chronic. (Id. ¶ 23.) Acute Hepatitis C is a short-term illness that occurs within the first six months of exposure to the virus and can lead to chronic Hepatitis C. (Id.) Chronic Hepatitis C is a “long-term illness[] that can last throughout a person’s life” and is “the leading cause of cirrhosis (irreversible scarring of liver tissue) and liver cancer and is the most common cause of liver transplants.” (Id. ¶ 24.) Chronic Hepatitis C can also lead to chronic liver disease, liver fibrosis, and death. (Id.) Approximately twenty percent of the “inmates under the supervision of the DOC are currently infected with Hepatitis C.” (Id. ¶ 30.)
In the past, the standard treatment for Hepatitis C infections, “which included the use of interferon and ribavirin medications, failed to cure large numbers of patients and was associated with painful and other adverse side-effects, including psychiatric and autoimmune disorders, flulike symptoms, and gastrointestinal distress.” (Id. ¶ 32.) Over the past few years, the Federal Drug Administration (“FDA”) has approved new direct-acting antiviral drugs (“DAAD”) to treat Hepatitis C infections. (Id. ¶ 33.) “In 2011, the FDA approved the use of protease inhibitors called boceprevir . . . and telaprevir . . . and the standard of care developed into a ‘triple therapy’ to include the combination of either boceprevir or telaprevir, plus ribavirin and interferon” (Id. ¶ 34.) This new triple therapy improved results for many patients, but still led to “painful and
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adverse side effects,” and the treatment could last for as many as 48 weeks. (Id.) In 2013, the FDA approved two new DAAD medications called simeprevir (brand name Olysio) and sofosbuvir (brand name Sovaldi). (Id. ¶ 35.) The recommended treatment became a combination of a “DAAD such as Sovaldi combined with ribavirin, or with interferon, depending on the patient’s other symptoms and medical diagnoses.” (Id.) “In late 2014, the FDA approved the use of Sovaldi in combination with Olysio for the treatment of Hepatitis C.” (Id. ¶ 36.) “On October 10, 2014, the FDA . . . approved Harvoni, a pill that is taken once a day and combines sofosbuvir and ledipasvir.” (Id. ¶ 37.) A patient who takes Harvoni does not need to take interferon and/or ribavirin, the drugs “largely responsible for the adverse and difficult sideeffects of treating Hepatitis C.” (Id. ¶ 38.) The new drugs, i.e., Solvaldi, Olysio, and Harvoni, have few side effects, have greater efficacy than older treatments for Hepatitis C, and can be taken for significantly less time (75% less) than prior Hepatitis C treatments. (Id. ¶ 39.) Use of the latest DAAD medications is now the standard of care in the community for the treatment of Hepatitis C infections. (Id. ¶ 41.) “The CDC has recommended these new treatment modules and the Federal Bureau of Prisons (BOP), in 2014, adopted new Clinical Practice Guidelines that incorporate these new DAAD treatment modules.” (Id.)
Defendants have not implemented these new treatment modules for the treatment of Hepatitis C infections within the DOC. (Id. ¶ 43.) Rather, Defendants have “ceased providing any treatment to inmates with Hepatitis C infections, including the combination therapy of interferon and ribavirin, or the triple therapy of boceprevir/telaprevir with interferon and ribavirin.” (Id. ¶ 44.) Defendants have denied requests by the Plaintiffs and others for DAAD medications to treat their Hepatitis C infections. (Id. ¶ 45.) Inmates who seek medical treatment for their Hepatitis C infections have been informed that the “DOC/BHCS is revaluating [their]
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treatment protocol for Hepatitis C given the new guidance issued by the American Association of Liver Diseases (AASLD) and the Infectious Diseases Society of American [sic] (IDSA).”1 (Id. ¶ 48 (first alteration in original).) Consequently, Plaintiffs and others “have not received the necessary medical treatment for Hepatitis C, including the latest DAAD such as Solvaldi . . . , Olysio . . . , or Harvoni . . .” and “have a substantially increased risk of continued Hepatitis C infection, liver disease, liver cancer, cirrhosis, and death.” (Id. ¶¶ 49-50.)
Chimenti was first diagnosed with Hepatitis C in 1991. (Id. ¶ 53.) He has received different treatments from the DOC since that time, but has not been cured and currently suffers from “Stage 4 compensated cirrhosis with chronic liver failure.” (Id. ¶¶ 54-60.) Most recently, Chimenti was treated with the triple therapy at SCI Forest from June 2012 through May 2013. (Id. ¶ 59.) While he initially responded positively to the triple therapy, he relapsed after six months, in November 2013. (Id.) In late 2013, he began requesting treatment with DAAD medications, but Defendants have denied that treatment, even though treatment of Hepatitis C with Solvadi and ribavirin has an over 90% cure rate. (Id. ¶ 64.) Chimenti has also asked to be treated with Harvoni, but, in November 2014, Defendant William Dreibelbis, a Correctional Health Care Administrator (“CHCA”) at SCI Smithfield, informed Chimenti that “‘PA DOC has not approved the use of [Harvoni] at this time. Thus it is not offered at this facility.’” (Id. ¶¶ 13, 65 (alteration in original).)
Leyva was diagnosed with Hepatitis C in 2001 or 2002, while he was incarcerated at SCI Albion. (Id. ¶ 72.) He has been treated with interferon and ribavirin, but those drugs did not cure his infection. (Id. ¶ 73.) He has asked to be treated with the latest DAAD treatment, but was informed by his doctor that the treatment is too costly. (Id. ¶ 75.) Joseph Mataloni, the
1 The Bureau of Health Care Services (“BHCS”), a bureau within the DOC, oversees the provision of medical care to DOC inmates. (Id. ¶ 47.)
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CHCA at SCI Retreat, informed Leyva that “‘[t]he DOC is re-evaluating our treatment protocol for Hepatitis C given the new guidance issued by the American Association of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA).’” (Id. ¶ 77.) He was also informed by Christopher H. Oppman, Director of BHCS, that “DOC and BCHS are re-evaluating their treatment protocol.” (Id. ¶ 78.)
Maldonado was diagnosed with Hepatitis C in 1997. (Id. ¶ 81.) He was unsuccessfully treated with interferon and ribavirin in 2001. (Id. ¶ 82.) In June 2013, he was treated with the triple therapy of interferon, ribavirin and boceprevir. (Id. ¶ 83.) This treatment was initially successful, but failed after six months in December 2013. (Id.) He has asked to be treated with the latest DAAD treatment, but was informed by BHCS that a new protocol is being developed. (Id. ¶ 84.) Defendant Joseph C. Korszniak, the CHCA at SCI Graterford, informed Maldonado that Harvoni “‘has not yet been approved for use by the DOC, BHCS. When the protols [sic] are extablished [sic] and the drug is approved there will be an assessment done to determine who will qualify for the treatment.’” (Id. ¶ 85 (alterations in original).)
Plaintiffs seek to represent a class of all persons currently incarcerated in a DOC facility who have at least twelve weeks remaining in their sentences and are currently diagnosed with Hepatitis C. (Id. ¶ 90.) They assert four claims for relief. Count One asserts a claim pursuant to 42 U.S.C. § 1983 against the DOC Defendants, Correct Care Solutions, and employees of Correct Care Solutions for deliberate indifference to the serious medical needs of prisoners infected with Hepatitis C in violation of the Eighth Amendment to the United States Constitution. Count Two asserts a claim against the DOC Defendants, Correct Care Solutions, and employees of Correct Care Solutions for deliberate indifference to the serious medical needs of prisoners infected with Hepatitis C in violation of Article I, Section 13 of the Pennsylvania
5

Constitution. Count III asserts a claim against all Defendants for medical malpractice under Pennsylvania law. Count IV asserts a claim against Wexford Health and Correct Care Solutions for medical malpractice and vicarious liability under Pennsylvania law. II. THE DOC DEFENDANTS’ MOTION TO DISMISS
The DOC Defendants seek dismissal of Count I of the Complaint as against four of the DOC Defendants named in that Count for failure to state a claim upon which relief may be granted pursuant to Federal Rule of Civil Procedure 12(b)(6). They also seek dismissal of Counts II and III in their entireties pursuant to Rule 12(b)(6). In addition, the DOC Defendants ask us to dismiss the Complaint in its entirety for improper venue pursuant to Federal Rule of Civil Procedure 12(b)(3).
A. Rule 12(b)(6) When considering a motion to dismiss pursuant to Rule 12(b)(6), we “consider only the complaint, exhibits attached to the complaint, [and] matters of public record, as well as undisputedly authentic documents if the complainant’s claims are based upon these documents.” Mayer v. Belichick, 605 F.3d 223, 230 (3d Cir. 2010) (citing Pension Benefit Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir. 1993)). We take the factual allegations of the complaint as true and “construe the complaint in the light most favorable to the plaintiff.” DelRio-Mocci v. Connolly Props., Inc., 672 F.3d 241, 245 (3d Cir. 2012) (citing Warren Gen. Hosp. v. Amgen, Inc., 643 F.3d 77, 84 (3d Cir. 2011)). Legal conclusions, however, receive no deference, as the court is “‘not bound to accept as true a legal conclusion couched as a factual allegation.’” Wood v. Moss, 134 S. Ct. 2056, 2065 n.5 (2014) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)).
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A plaintiff’s pleading obligation is to set forth “a short and plain statement of the claim,” which gives “‘the defendant fair notice of what the . . . claim is and the grounds upon which it rests.’” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (alteration in original) (quoting Fed. R. Civ. P. 8(a)(2), and Conley v. Gibson, 355 U.S. 41, 47 (1957)). The complaint must contain “‘sufficient factual matter to show that the claim is facially plausible,’ thus enabling ‘the court to draw the reasonable inference that the defendant is liable for [the] misconduct alleged.’” Warren Gen. Hosp., 643 F.3d at 84 (quoting Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009)). “The plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Iqbal, 556 U.S. at 678 (citing Twombly, 550 U.S. at 556). ). “A complaint that pleads facts ‘merely consistent with a defendant’s liability . . . stops short of the line between possibility and plausibility of entitlement to relief.’” Connelly v. Lane Constr. Corp., 809 F.3d 780, 786-87 (3d Cir. 2016) (quoting Iqbal, 556 U.S. at 678). “The plausibility determination is ‘a context-specific task that requires the reviewing court to draw on its judicial experience and common sense.’” Id. at 786 (quoting Iqbal, 556 U.S. at 679). In the end, we will grant a motion to dismiss brought pursuant to Rule 12(b)(6) if the factual allegations in the complaint are not sufficient “‘to raise a right to relief above the speculative level.’” W. Run Student Hous. Assocs., LLC v. Huntington Nat’l Bank, 712 F.3d 165, 169 (3d Cir. 2013) (quoting Twombly, 550 U.S. at 555).
B. Count I Count I asserts an Eighth Amendment deliberate indifference claim pursuant to 42 U.S.C. § 1983 against twelve of the Defendants, including all six of the DOC Defendants: the DOC; John Wetzel, the Secretary of the DOC; Paul Noel, Chief Medical Director of the DOC; Oppman; Dreibelbis; and Korszniak. The DOC Defendants have moved to dismiss this Count as
7

against Wetzel, Noel, Dreibelbis, and Korszniak pursuant to Rule 12(b)(6) on the ground that the Complaint does not allege that these Defendants were personally involved in the alleged violation of Plaintiffs’ rights.
Section 1983 provides, in pertinent part, as follows: Every person who, under color of any statute, ordinance, regulation, custom, or usage, of any State or Territory or the District of Columbia, subjects, or causes to be subjected, any citizen of the United States or other person within the jurisdiction thereof to the deprivation of any rights, privileges, or immunities secured by the Constitution and laws, shall be liable to the party injured in an action at law, suit in equity, or other proper proceeding for redress . . . . 42 U.S.C. § 1983. “Section 1983 provides remedies for deprivations of rights established in the Constitution or federal laws. It does not, by its own terms, create substantive rights.” Kaucher v. Cty. of Bucks, 455 F.3d 418, 423 (3d Cir. 2006) (footnote omitted) (citing Baker v. McCollan, 443 U.S. 137, 145 n.3 (1979)). Consequently, in order to state a claim for relief pursuant to § 1983, “a plaintiff must demonstrate the defendant, acting under color of state law, deprived him or her of a right secured by the Constitution or the laws of the United States.” Id. (citing Am. Mfrs. Mut. Ins. Co. v. Sullivan, 526 U.S. 40, 49–50 (1999), and Mark v. Borough of Hatboro, 51 F.3d 1137, 1141 (3d Cir. 1995)). Count I alleges that the twelve named Defendants’ “acts and omissions in failing to provide adequate medical care constitute a deliberate indifference to the serious medical needs of prisoners infected with Hepatitis C, thereby establishing a violation of the Eighth Amendment.” (Compl. ¶ 99.) The Eighth Amendment’s right to be free from cruel and unusual punishment, which applies to the states via the Fourteenth Amendment, Estelle v. Gamble, 429 U.S. 97, 10102 (citation omitted), “imposes duties on [prison] officials, who must . . . ensure that inmates receive adequate . . . medical care, and must ‘take reasonable measures to guarantee the safety of the inmates.’” Farmer v. Brennan, 511 U.S. 825, 832 (1994) (quoting Hudson v. Palmer, 468
8

U.S. 517, 526–27 (1984)). To state a claim under the Eighth Amendment for denial of medical care, a plaintiff must plausibly allege that a defendant showed “deliberate indifference to serious medical needs of [a] prisoner[ ].” Estelle, 429 U.S. at 104. Courts have consistently held that “mere allegations of malpractice” are not sufficient to allege “deliberate indifference.” Id. at 106 n.14.
“Deliberate indifference can be shown by a prison official ‘intentionally denying or delaying access to medical care or intentionally interfering with the treatment once prescribed.’” Rhines v. Bledsoe, 388 F. App’x 225, 227 (3d Cir. 2010) (quoting Estelle, 429 U.S. at 104–05). “A medical need is serious if it ‘has been diagnosed by a physician as requiring treatment or one that is so obvious that a lay person would easily recognize the necessity for a doctor’s attention.’” Id. (quoting Monmouth Cty. Corr. Inst. Inmates v. Lanzaro, 834 F.2d 326, 347 (3d Cir. 1987)). Moreover, the medical need must be such that “‘a failure to treat can be expected to lead to substantial and unnecessary suffering, injury, or death.’” Tsakonas v. Cicchi, 308 F. App’x 628, 632 (3d Cir. 2009) (quoting Colburn v. Upper Darby Twp., 946 F.2d 1017, 2023 (3d Cir. 1991)).
A prison official acts with deliberate indifference to a serious medical need “when he knows of and disregards an excessive risk to inmate health or safety.” Brown v. Thomas, 172 F. App'x 446, 450 (3d Cir. 2006) (citing Farmer, 511 U.S. at 837). “The official must be aware of the facts from which an inference could be drawn that a substantial risk of serious harm exists, and he must also draw the inference.” Id. (citation omitted). Given these prerequisites to a valid constitutional claim based on deliberate indifference, factual allegations suggesting only an “‘ordinary lack of due care for the prisoner’s interests or safety’” will not suffice to meet the
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pleading requirements for deliberate indifference under the Eighth Amendment. Farmer, 511 U.S. at 835 (quoting Whitley v. Albers, 475 U.S. 312, 319 (1986)).
The DOC Defendants argue that the Complaint fails to plead a cognizable § 1983 claim against Wetzel, Noel, Dreibelbis and Korszniak because it does not allege any facts that, if true, would establish that these Defendants were personally involved in denying medical treatment for the Plaintiffs’ Hepatitis C infections. “‘A[n individual government] defendant in a civil rights action must have personal involvement in the alleged wrongdoing; liability cannot be predicated solely on the operation of respondeat superior. Personal involvement can be shown through allegations of personal direction or of actual knowledge and acquiescence.” Evancho v. Fisher, 423 F.3d 347, 353 (3d Cir. 2005) (alteration in original) (quoting Rode v. Dellarciprete, 845 F.2d 1195, 1207 (3d Cir. 1988)); see also Argueta v. U.S. Immigration & Customs Enf’t, 643 F.3d 60, 72 (3d Cir. 2011) (quoting Rode, 845 F.2d at 1207) (same). Thus, a conclusory allegation that defendants were “directly involved” in the violations of the plaintiff’s rights is not sufficient to allege personal involvement. Bush v. Dep’t of Human Servs., 614 F. App’x 616, 620 (3d Cir. 2015) (affirming dismissal of § 1983 complaint against city officials where the only allegation of personal involvement was the conclusory allegation that officials “were all ‘directly involved’” in the deprivation of plaintiff’s rights). See also Wright v. Warden, Forest SCI, 582 F. App’x 136, 137 (3d Cir. 2014) (affirming dismissal of § 1983 claim against prison officials where the allegations that those officials “had a ‘statutory duty to enforce policies’ and govern the ‘conduct of their subordinates’” failed to suggest the requisite personal involvement); Gorrell v. Yost, 509 F. App’x 114, 118 (3d Cir. 2013) (determining that allegation that mailroom officers were “responsible for the daily operations of the mail room” was “insufficient to establish personal liability” with respect to plaintiff’s claim regarding interference with his legal mail).
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The DOC Defendants argue that Count I must be dismissed as against Wetzel and Noel because the Complaint does not allege that either of these Defendants had any personal involvement in treating Plaintiffs, denying Plaintiffs treatment for Hepatitis C, or developing the DOC’s policies for treating Plaintiffs with Hepatitis C. However, the Complaint specifically alleges that Wetzel, as the Secretary of the DOC, “is responsible for all the oversight, operation, and administration of the Commonwealth’s correctional system, including providing appropriate medical treatment and the formulation of policies that ensure the provision of that treatment to Plaintiffs.” (Compl. ¶ 9.) We conclude that this allegation is sufficient to raise a reasonable inference of Wetzel’s personal involvement in the DOC’s policy of ceasing the provision of medical treatment to inmates with Hepatitis C and denying their requests for treatment with DAADs (id. ¶¶ 43-51), and we further conclude that the Complaint states a cognizable § 1983 claim against Wetzel for deliberate indifference to Plaintiffs’ serious medical needs in violation of the Eighth Amendment. See Barros v. Wetzel, Civ. A. No. 14-1746, 2015 WL 5785746, at *2, *4 (M.D. Pa. Sept. 29, 2015) (denying motion to dismiss § 1983 claim against Wetzel for violation of plaintiff’s First Amendment free exercise of religion rights where the complaint alleged that Wetzel’s policy directive caused the infringement); Cook v. Corbett, Civ. A. No. 14– 5895, 2015 WL 4111692, at *13 (E.D. Pa. July 8, 2015) (denying motion to dismiss § 1983 claim against Wetzel based on allegation that Wetzel maintained a policy that resulted in violation of plaintiff’s First Amendment right to free exercise of religion); Stokes v. Riskus, Civ. A. No. 14-60, 2015 WL 1326200, at *4 (W.D. Pa. Mar. 24, 2015) (denying motion to dismiss § 1983 claim against Wetzel for violation of the plaintiff’s Eighth Amendment right to be protected from assault by other inmates where the complaint alleged that Wetzel failed to develop a policy that would “protect inmates from assault while on protective custody”);
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Hampton v. Wetzel, Civ. A. No. 12-434, 2014 WL 1312013, at *14 (M.D. Pa. Mar. 31, 2014) (denying motion for summary judgment as to plaintiff’s § 1983 claim against Wetzel for violation of plaintiff’s Fourteenth Amendment right to equal protection where the record contained evidence that Wetzel “had a role in establishing and maintaining the policy or practice which allegedly resulted in differential treatment of [plaintiff]”). We therefore deny the DOC Defendants’ Motion to Dismiss as to the claim asserted against Wetzel in Count I of the Complaint.
In contrast to the Complaints’ allegations regarding Wetzel, the only allegations concerning Noel state that he is “the Chief Medical Director of the DOC” and, as such, “has responsibility in overseeing the delivery of medical services in the DOC.” (Id. ¶ 10.) The Complaint contains no other allegations suggesting that Noel was personally involved in the denial of medical care to Plaintiffs or was involved in the development of the DOC’s policy with respect to medical treatment for Hepatitis C. We therefore conclude that the Complaint does not sufficiently allege that Noel had personal involvement in the alleged violation of Plaintiffs’ Eighth Amendment rights to plausibly state a § 1983 claim against him for deliberate indifference to Plaintiffs’ serious medical needs in violation of the Eighth Amendment. We thus grant the DOC Defendants’ Motion to Dismiss as to the claim asserted against Noel in Count I of the Complaint.
The DOC Defendants also argue that Count I should be dismissed as against Dreibelbis and Korszniak because they are not physicians, do not develop medical policies, and do not personally deliver medical care. Defendants further argue that Dreibelbis’s and Korszniak’s alleged denial of grievances with respect to medical issues does not raise an inference that they were deliberately indifferent to an inmate’s medical needs. Defendants rely on Fantone v.
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Herbik, 528 F. App’x 123 (3d Cir. 2013), in which the United States Court of Appeals for the Third Circuit concluded that a prison administrator’s denial of an inmate’s grievance with respect to his medical care does not amount to deliberate indifference to his serious medical needs where there is no evidence that the administrator “had a reason to believe that the prison doctors were either mistreating or not treating [plaintiff], or that they inappropriately handled his grievances.” Id. at 128.
The Complaint alleges that Dreibelbis, as a CHCA, “is responsible for the oversight of health care at SCI Smithfield,” that he personally failed “to have Mr. Chimenti seen or evaluated by a hepatologist or a gastroenterologist for proper treatment of his liver condition,” and that he personally informed Mr. Chimenti that the “‘PA DOC has not approved the use of [Harvoni] at this time. Thus it is not offered at this facility.’” (Compl. ¶¶ 13, 63, 65 (alteration in original).) The Complaint thus specifically alleges that Dreibelbis personally failed to have Mr. Chimenti treated by the appropriate medical specialist and that he informed Chimenti that he would not receive the medical care he sought, i.e., treatment with a DAAD, even though Dreibelbis knew that Chimenti was not being treated by an appropriate medical specialist. Such allegations support a reasonable inference that Dreibelbis denied Chimenti’s requests for medical care even though he “had a reason to believe that the prison doctors were . . . not treating [Chimenti].” Fantone, 528 F. App’x at 128. We conclude, accordingly, that the Complaint sufficiently alleges that Dreibelbis was personally involved in the denial of medical treatment to Chimenti and was deliberately indifferent to Chimenti’s serious medical needs to plausibly state a § 1983 claim against him for violation of the Eighth Amendment. We therefore deny the DOC Defendants’ Motion to Dismiss as to the claim asserted against Dreibelbis in Count I of the Complaint.
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The Complaint alleges that Korszniak, as a CHCA, “is responsible for the oversight of health care at SCI Graterford” and that he personally rejected Mr. Maldonado’s grievance regarding the denial of his request to be treated with Harvoni, stating that the “‘drug [Harvoni] that you mention has not yet been approved for use by the DOC, BHCS. When the protols [sic] are extablished [sic] and the drug is approved there will be an assessment done to determine who will qualify for the treatment.’” (Id. ¶¶ 15, 85 (alterations in original).) We conclude that these allegations support a reasonable inference that Korszniak denied Maldonado medical care even though he “had a reason to believe that the prison doctors were . . . not treating [Maldonado].” Fantone, 528 F. App’x at 128. We conclude, accordingly, that the Complaint sufficiently alleges that Korszniak was personally involved in the denial of medical treatment to Maldonado and was deliberately indifferent to Maldonado’s serious medical needs to state a plausible § 1983 claim against him for violation of the Eighth Amendment. We consequently deny the DOC Defendants’ Motion to Dismiss as to the claim asserted against Korszniak in Count I of the Complaint.
In summary, the DOC Defendants’ Motion to Dismiss is granted in part and denied in part with respect to Count I of the Complaint. The Motion is granted as to Noel and denied as to Wetzel, Dreibelbis and Korszniak.
C. Count II Count II of the Complaint asserts a claim against twelve Defendants, including all six of the DOC Defendants, for violation of Article I, § 13 of the Pennsylvania Constitution, which provides that “[e]xcessive bail shall not be required, nor excessive fines imposed, nor cruel punishments inflicted.” Pa. Const. Art. 1, § 13. “This language parallels the Eighth Amendment of the United States Constitution. Thus, the Pennsylvania prohibition is coextensive with the
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Eighth and Fourteenth Amendments of the United States Constitution.” Tejada v. Corr. Officer Dale, Civ. A. No. 14-5604, 2015 WL 5729273, at *4 (E.D. Pa. Sept. 30, 2015) (citing Commonwealth v. Cottam, 616 A.2d 988, 1003 (Pa. Super. Ct. 1992)). Consequently, the same legal standard “‘applies to claims brought under Article 1, Section 13 of the Pennsylvania Constitution’” as applies to claims brought pursuant to the Eighth Amendment. Id. (citing Eliason v. Cty. of Lehigh, Civ. A. No. 08-5755, 2009 WL 2526199, at *4 (E.D. Pa. Aug. 14, 2009)).
The DOC Defendants argue that Count II should be dismissed to the extent that Plaintiffs seek monetary damages for any violation of the Pennsylvania Constitution. Indeed, “[n]o Pennsylvania statute establishes, and no Pennsylvania court has recognized, a private cause of action for damages under the Pennsylvania Constitution.” Pocono Mountain Charter Sch. v. Pocono Mountain Sch. Dist., 442 F. App’x 681, 687 (3d Cir. 2011) (citing Jones v. City of Phila., 890 A.2d 1188, 1208 (Pa. Commw. Ct. 2006)). However, Plaintiffs have unequivocally stated that they “only seek injunctive relief under the Pennsylvania Constitution.” (Pls.’ Consolidated Response at 18.) Accordingly, we deny the DOC Defendants’ Motion to Dismiss insofar as it seeks dismissal of the damages claim in Count II of the Complaint because Plaintiffs do not seek damages in connection with Count II.
D. Count III Count III of the Complaint asserts a claim against twelve Defendants, including five of the DOC Defendants (the DOC, Wetzel, Noel, Oppman, and Dreibelbis), for medical malpractice under Pennsylvania law. Count III alleges that the DOC Defendants “had a duty to act in accordance with the standard of care required of medical professionals,” that “they breached that duty in failing to provide the standard of care necessary for individuals infected with Hepatitis C,
15

and [that] Plaintiffs’ injuries were the direct, legal and proximate result of Defendants[’] negligence.” (Compl. ¶ 103.) The DOC Defendants seek the dismissal of Count III as against Defendant Wetzel on the ground that he has sovereign immunity as to this claim. The DOC Defendants also ask us to dismiss this Count as to the four other named DOC Defendants on the ground that the Complaint does not allege sufficient facts to state a claim for negligence under Pennsylvania law.
1. Sovereign immunity “The doctrine of sovereign immunity, codified at 1 Pa.C.S. § 2310, protects the Commonwealth and its employees from . . . a suit for monetary damages unless the cause of action falls within one of several statutory exceptions . . . .” Johnson v. Townsend, 314 F. App’x 436, 439 (3d Cir. 2008); see also 1 Pa. Cons. Stat. Ann. § 2310 (“[I]t is hereby declared to be the intent of the General Assembly that the Commonwealth, and its officials and employees acting within the scope of their duties, shall continue to enjoy sovereign immunity and official immunity and remain immune from suit except as the General Assembly shall specifically waive the immunity.”). The General Assembly has waived sovereign immunity and consented to suit only with respect to claims for damages arising from: (1) “[v]ehicle liability;” (2) “[m]edicalprofessional liability;” (3) “[c]are, custody or control of personal property;” (4) “Commonwealth real estate, highways and sidewalks;” (5) “[p]otholes and other dangerous conditions;” (6) “[c]are, custody or control of animals;” (7) “[l]iquor store sales;” (8) “National Guard activities;” and (9) “[t]oxoids and vaccines.” 42 Pa. Cons. Stat. Ann. § 8522(b). These exceptions to sovereign immunity are “strictly construed and narrowly interpreted.” Brown v. Blaine, 833 A.2d 1166, 1173 (Pa. Commw. Ct. 2003) (citing Bufford v. Pa. Dep’t of Transp., 670 A.2d 751 (Pa. Commw. Ct. 1996)). The DOC Defendants maintain that, while the General Assembly has
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waived sovereign immunity as to suits for “medical-professional liability,” that exception does not apply to Wetzel because he is not a medical professional.
Section 8522 specifies that the “medical-professional liability” exception to sovereign immunity applies to “[a]cts of health care employees of Commonwealth agency medical facilities or institutions or by a Commonwealth party who is a doctor, dentist, nurse or related health care personnel.” 42 Pa. Cons. Stat. Ann. § 8522(b)(2). The Complaint does not allege that Wetzel is a “health care employee[] of [a] Commonwealth agency medical facilit[y] or institution[].” Id. The Complaint also contains no allegations that Wetzel is “a doctor, dentist, nurse or related health care personnel.” Id. Plaintiffs argue that Wetzel should nonetheless be treated as a healthcare employee of the BOP because he “directly established the impermissibly restricted medical policy.” (Pls.’ Consolidated Response at 17.) However, Plaintiffs have cited no authority for the proposition that a Commonwealth official who is not a “healthcare employee[] of [a] Commonwealth agency medical facilit[y] or institution[]” and is not “a doctor, dentist, nurse or related health care personnel” should be treated as a healthcare employee simply because he participated in the establishment of a medical policy. Indeed, “it is well-settled that immunity is waived only for claims asserted against health care employees, and not to individuals who are not medical professionals.” Green v. Fisher, Civ. A. No. 12-982, 2014 WL 65763, at *11 (M.D. Pa. Jan. 8, 2014) (dismissing medical care negligence claim against the warden, deputy warden, safety manager, maintenance manager, and food service manager of SCI Smithfield on sovereign immunity grounds because none of those defendants were health care employees (citing McCool v. Dep’t of Corr., 984 A.2d 565, 570 (Pa. Commw. Ct. 2009))); see also Robus v. Pa. Dep’t of Corr., Civ. A. No. 04-2175, 2006 WL 2060615, at *4 (E.D. Pa. July 20, 2006) (dismissing state law negligence claim for inadequate medical care asserted against the
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superintendent of SCI Graterford on sovereign immunity grounds since the superintendent of the prison was not a health care employee).
We conclude that the Pennsylvania state law medical malpractice claim asserted against Wetzel in Count III is barred by sovereign immunity because Wetzel is an employee of the Commonwealth of Pennsylvania and no exceptions to sovereign immunity apply. See 1 Pa. Cons. Stat. Ann. § 2310; 42 Pa. Cons. Stat. Ann. § 8522. Consequently, we grant the DOC Defendants’ Motion to Dismiss as to the claim asserted against Wetzel in Count III of the Complaint.
2. Medical Malpractice The Pennsylvania courts define medical malpractice “‘as the unwarranted departure from generally accepted standards of medical practice resulting in injury to a patient, including all liability-producing conduct arising from the rendition of professional medical services.’” Pomroy v. Hosp. of Univ. of Pa., 105 A.3d 740, 744-45 (Pa. Super. Ct. 2014) (quoting Toogood v. Owen J. Rogal, D.D.S., P.C., 824 A.2d 1140, 1145 (Pa. 2003)), appeal denied, 117 A.3d 298 (Pa. 2015). “[T]o state a prima facie cause of action [for medical malpractice], a plaintiff must demonstrate the elements of negligence: a duty owed by the physician to the patient, a breach of that duty by the physician, that the breach was the proximate cause of the harm suffered, and the damages suffered were a direct result of [the] harm.” Stimmler v. Chestnut Hill Hosp., 981 A.2d 145, 154 (Pa. 2009) (quoting Quinby v. Plumsteadville Family Practice, 907 A.2d 1061, 107071) (Pa. 2006)). The DOC Defendants argue that Count III should be dismissed as against the DOC, Noel, Oppman, and Dreibelbis because the Complaint does not allege the manner in which the actions or omissions of each of these Defendants were substantial causes of any injury to the
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Plaintiffs. Specifically, they argue that the Complaint does not allege that Plaintiffs’ inability to
obtain the new DAAD treatments for their Hepatitis C has caused a specific, identifiable injury.
The Complaint alleges that Chimenti has “Stage 4 compensated cirrhosis with chronic liver failure” and “his Model for End-Stage Liver Disease (‘MELD’) score is 12.”2 (Compl. ¶
60.) The Complaint further alleges that, in 2009, Dr. Abhinav Humar, the Chief Liver
Transplant Specialist from the University of Pittsburgh Medical Center, “recommended that Mr.
Chimenti be assessed with ultrasounds and CT scans of his liver every six months, and that if
[his] ‘MELD’ score went above 10, that he be evaluated by a hepatologist for the possibility of a liver transplant.” (Id. ¶ 61.) However, since November 2013, the Defendants3 have denied
Chimenti the treatment he needs to track and stop the effects of his Hepatitis C, including the
regular ultrasounds and CT scans recommended by Dr. Humar. (Id. ¶ 62.) Moreover, Dreibelbis
has failed to have Chimenti seen or evaluated by a hepatologist or a gastroenterologist for
treatment of his liver condition. (Id. ¶ 63.) The Complaint further alleges that, as a result of
Defendants’ failure to provide Chimenti with access to DAADs and other medical services for
treatment of his Hepatitis C, he “continues to suffer from chronic Hepatitis C infection and the
related risks of liver failure and death, and physical and emotional pain and suffering.” (Id. ¶
68.) Furthermore, as a result of Chimenti’s advanced cirrhosis, he urgently needs medical
treatment, because once his liver decompensates, the only possible treatment will be a liver
2“The MELD score is a measure of mortality risk in patients with end-stage liver disease and is used as a disease severity index to help prioritize allocation of organs for transplant.” (Compl. ¶ 60.)
3Drawing all inferences in favor of Plaintiffs, we infer that the Complaint’s general allegations as to the actions of “Defendants” constitute an allegation that the referenced action or omission was taken by the DOC; by Noel who, as the Chief Medical Director of the DOC, is alleged to be responsible for overseeing the delivery of medical services in the DOC; and by Oppman who, as the Director of BHCS, is responsible for supervising and monitoring medical services in the DOC. (See Compl. ¶¶ 10-11.)
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transplant. (Id. ¶ 69.) Given these allegations, we conclude that the Complaint sufficiently alleges that the failure of the DOC, Noel, Oppman and Dreibelbis to provide Chimenti with the appropriate medical care for his Hepatitis C has injured him, as it alleges that because these Defendants denied Chimenti necessary medical care, he continues to suffer from Hepatitis C infection, risks liver failure and death, and may have to undergo a liver transplant.
The Complaint alleges that Leyva has high levels of the Hepatitis C virus, for which he has not been provided treatment with DAADs in spite of his specific requests for such treatment. (Id. ¶¶ 75-78.) The Complaint further alleges that Oppman personally denied Leyva’s request for such treatment. (Id. ¶ 78.) The Complaint also alleges that Leyva “currently experiences symptoms of Hepatitis C, including pain, fatigue,” and jaundice and that he “requires immediate treatment to prevent any further liver damage.” (Id. ¶ 79.) We conclude that the Complaint sufficiently alleges that Oppman’s failure to provide Leyva with the appropriate medical care for his Hepatitis C has injured him, in that it alleges that because Oppman denied Leyva necessary medical care, he continues to suffer from symptoms of Hepatitis C, including pain, fatigue, and jaundice.
The Complaint alleges that Maldonado had a liver biopsy in 2013, which showed that he had liver fibrosis between stage 1 and stage 2. (Id. ¶ 83.) He has not received treatment for his Hepatitis C since December 2013, even though he has requested treatment with DAADs. (Id. ¶¶ 83-86.) The Complaint specifically alleges that Maldonado’s request for DAAD treatment was denied because of a decision by the DOC and BHCS. The Complaint further alleges that Maldonado needs immediate treatment to prevent any further liver damage or liver failure as a result of his Hepatitis C. (Id. ¶ 87.) We conclude that the Complaint sufficiently alleges that the DOC and Oppman, the Director of the BHCS, have failed to provide Maldonado with the
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appropriate medical care for his Hepatitis C and that such failure has injured Maldonado, in that it alleges that because the DOC and BHCS denied Maldonado necessary medical care, he requires immediate treatment of his Hepatitis C to prevent further liver damage or liver failure.
We conclude that the Complaint alleges sufficient facts regarding the harm that all three Plaintiffs have suffered as a result of the actions of the DOC, Noel, Oppman, and Dreibelbis in denying Plaintiffs DAAD treatment to state a facially plausible claim for medical malpractice under Pennsylvania law. We accordingly deny the DOC Defendants’ Motion to Dismiss as to the medical malpractice claim asserted against the DOC, Noel, Oppman, and Dreibelbis in Count III of the Complaint.
In summary, the DOC Defendants’ Motion to Dismiss is granted in part and denied in part with respect to Count III of the Complaint. The Motion is granted as to Wetzel and denied as to the DOC, Noel, Oppman, and Dreibelbis.
E. Improper Venue The DOC Defendants argue that the Complaint should be dismissed for improper venue pursuant to Federal Rule of Civil Procedure 12(b)(3) and 28 U.S.C. § 1406.4 “A defendant seeking to dismiss a case for improper venue under Rule 12(b)(3) bears the burden of demonstrating that venue is improper.” Cont’l Materials, Inc. v. Robotex, Inc., Civ. A. No. 146941, 2015 WL 1782053, at *2 (E.D. Pa. Apr. 17, 2015) (citing Cargill Cocoa & Chocolate, Inc. v. Abco Labs., Inc., Civ. A. No. 13–6004, 2014 WL 4795028, at *2 (E.D. Pa. Sept. 26, 2014)).
4Although the DOC Defendants do not specifically rely on 28 U.S.C. § 1406, the Third Circuit has made it clear that § 1406 governs the venue issue raised in their Motion to Dismiss. See Jumara v. State Farm Ins. Co., 55 F.3d 873, 878 (3d Cir. 1995) (“In federal court, venue questions are governed either by 28 U.S.C. § 1404(a) or 28 U.S.C. § 1406. Section 1404(a) provides for the transfer of a case where both the original and the requested venue are proper. Section 1406, on the other hand, applies where the original venue is improper and provides for either transfer or dismissal of the case.”).
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When we decide a motion to dismiss for improper venue, we accept the allegations of the Complaint as true, “‘although the parties may submit affidavits in support of their positions,’ and [we] must ‘draw all reasonable inferences and resolve all factual conflicts in the plaintiff[’]s favor.’” Id. (second alteration in original) (quoting Giuliano v. CDSI I Holding Co., Civ. A. No. 13–2776, 2014 WL 1032704, at *1 (E.D. Pa. Mar. 17, 2014)).
Plaintiffs maintain that venue is proper in this district pursuant to 28 U.S.C. § 1391(b)(2).5 We “undertake a two-part inquiry” of the DOC Defendants’ challenge to venue under § 1391(b)(2). Lannett Co. v. Asherman, Civ. A. No. 13-2006, 2014 WL 716699, at *3 (E.D. Pa. Feb. 24, 2014). “First, we ‘identify the nature of the claims and the acts or omissions that the plaintiff alleges give rise to those claims.’” Id. (quoting Chester v. Beard, Civ. A. No. 07–4742, 2008 WL 2310946, at *7 (E.D. Pa. June 2, 2008)). “‘The test for determining venue is not the defendant’s contacts with a particular district, but rather the location of those events or omissions giving rise to the claim . . . .’” Id. (alteration in original) (quoting Cottman Transmissions Sys. v. Martino, 36 F.3d 291, 294 (3d Cir. 1994)). “Second, we ‘determine whether a substantial part of those acts or omissions . . . material to [those] claims . . . have occurred in the district in question.’” Id. (alterations in original) (quoting Chester, 2008 WL 2310946, at *7).
Section 1391(b) provides that “[a] civil action may be brought in -- . . . (2) a judicial district in which a substantial part of the events or omissions giving rise to the claim occurred . . .
5The Complaint alleges that venue is proper in this district pursuant to 28 U.S.C. § 1391(g), which clearly does not apply in this case. Plaintiffs argue, in their Response to the Motion to Dismiss, that venue is appropriate in this district pursuant to 28 U.S.C. § 1391(b)(2). We assume, accordingly, that the reference to § 1391(g) in the Complaint was a typographical error and that Plaintiffs intended to allege venue pursuant to § 1391(b)(2). The DOC Defendants, in their Memorandum, address the propriety of venue in this district solely with respect to § 1391(b)(2).
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.” 28 U.S.C. § 1391(b). The Complaint alleges that venue is appropriate in this district because “substantial events at issue in this litigation occurred in the Eastern District of Pennsylvania.” (Compl. ¶ 4.) Plaintiffs’ claims arise from the medical care given to the Plaintiffs and the Defendants’ failure to approve the Plaintiffs’ requests for treatment with DAAD medications. Plaintiffs maintain that a substantial part of the events giving rise to their claims occurred in this district because one Plaintiff, Maldonado, resides in this district and was denied medical care in this district. The Complaint alleges that Maldonado is incarcerated in this district and that decisions regarding the medical care for his Hepatitis C infection, including the decision to deny treatment with DAAD medications, were made by individuals employed by the DOC who are also located in this district. (Id. ¶¶ 7, 14, 15, 84-85.) Defendants have submitted no evidence regarding the location of Maldonado’s medical care or where decisions were made regarding Maldonado’s medical care. Drawing all inferences in favor of the Plaintiffs, we therefore conclude that a substantial part of the events or omissions giving rise to Plaintiffs’ claims thus occurred in this district.
The DOC Defendants argue that venue is, however, improper in this district because the formulation of the DOC’s policy relating to the treatment of Hepatitis C occurred at the Central Office of the BOP, which is located in the Middle District of Pennsylvania. Defendants rely on our decision in Chester, in which we stated that, in cases “where plaintiffs challenge state-wide policies, and not merely the actions of state officials in a single county, venue is proper pursuant to Section 1391(b)(2) in the district where those policies are developed.” Chester, 2008 WL 2310946, at *8 (citing Stanton-Negley Drug Co. v. Pa. Dep’t of Public Welfare, Civ. A. No. 071309, 2008 WL 1881894, at *5 (W.D. Pa. Apr. 24, 2008); Perkins v. Snyder, Civ. A. No. 944785, 1994 WL 530045, at *2-3 (E.D. Pa. Sept. 2, 1994); Leroy v. Great W. United Corp., 443
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U.S. 173, 185-86 (1979)). We further concluded in Chester that, under the circumstances presented in that case, the district in which the policy was developed was the only proper venue. Id. Chester, unlike the instant case, involved the constitutionality of the DOC’s lethal injection protocol. Id. at *1-3. The Chester defendants argued that venue was improper in the Eastern District of Pennsylvania because that protocol was developed solely in the Middle District of Pennsylvania and they submitted evidence (the declaration of the then-Secretary of the DOC) that all of “Pennsylvania’s [d]epartmental procedures and policies related to execution by lethal injection are formulated and promulgated solely at DOC headquarters in Camp Hill, Cumberland County, Pennsylvania and [t]he only institution at which those procedures are utilized is SCIRockview[,] located in Bellefonte, Centre County, Pennsylvania.” Id. at *7 (internal quotation omitted). Both Camp Hill and Bellefonte are located in the Middle District of Pennsylvania. Id. The Chester plaintiffs did not assert that the DOC’s lethal injection policies or protocols were developed or carried out in the Eastern District of Pennsylvania. They asserted only that they were incarcerated and had sought habeas relief in the Eastern District. Id. Because the record in that case contained no allegations or evidence that the DOC’s lethal injection protocols were developed or carried out in the Eastern District of Pennsylvania, we determined that the Eastern District was “not ‘a judicial district in which a substantial part of the events or omissions giving rise to the claim occurred.’” Id. at *8 (quoting 28 U.S.C. § 1391(b)(2)).
The Complaint in this case, unlike the Complaint in Chester, alleges that decisions pursuant to the policy in question were made and carried out in this district, and the Defendants have submitted no evidence to the contrary. Indeed, the DOC Defendants have supplied no evidence whatsoever in support of their position that their policy regarding the treatment of Hepatitis C was formulated in the Middle District of Pennsylvania. We thus conclude that the
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DOC Defendants have failed to satisfy their burden of demonstrating that venue is improper in this district. Drawing all inferences in favor of the Plaintiffs, we further conclude that venue is appropriate in this district pursuant to 28 U.S.C. § 1391(b)(2). We therefore deny the DOC Defendants’ Motion to Dismiss to the extent that it seeks dismissal of the Complaint for improper venue pursuant to Rule 12(b)(3) and 28 U.S.C. § 1406.
F. Request to Transfer The DOC Defendants ask, in the alternative, that we transfer this action to the Middle District of Pennsylvania pursuant to 28 U.S.C. § 1404. Section 1404 provides that “[f]or the convenience of parties and witnesses, in the interest of justice, a district court may transfer any civil action to any other district or division where it might have been brought or to any district or division to which all parties have consented.” 28 U.S.C. § 1404(a). “The district court has broad discretion in deciding a motion for transfer of venue.” Synthes, Inc. v. Knapp, 978 F. Supp. 2d 450, 458 (E.D. Pa. 2013) (citing Stewart Org., Inc. v. Ricoh Corp., 487 U.S. 22, 29 (1988)). “‘The burden of establishing the need for transfer [under § 1404(a)] . . . rests with the movant.’” Thompson v. Glob. Mktg. Research Servs., Inc., Civ. A. No. 15-3576, 2016 WL 233702, at *3 (E.D. Pa. Jan. 20, 2016) (alteration in original) (quoting Jumara v. State Farm Ins. Co., 55 F.3d 873, 879 (3d Cir. 1995)). “[T]he Third Circuit has explicitly stated that defendants have the burden of proof to support their motion to transfer with any affidavits, depositions, stipulations, or other documents containing facts that would tend to establish the necessary elements for a transfer under 28 U.S.C. § 1404(a).” Argro v. Marriott Int’l, Inc., Civ. A. No. 13-5507, 2014 WL 2572804, at *2 (E.D. Pa. June 6, 2014) (referring to Plum Tree, Inc. v. Stockment, 488 F.2d 754, 756-57 (3d Cir. 1973) (quotation omitted)); see also Plum Tree, 488 F.2d at 756-57 (determining that defendants failed to satisfy their burden of proof with respect to their motion to
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transfer because they failed to support their motion “with any affidavits, depositions,
stipulations, or other documents containing facts that would tend to establish the necessary
elements for a transfer under 28 U.S.C. § 1404(a)”).
Our first obligation under § 1404 is to determine whether this action could have been
brought in the Middle District of Pennsylvania, the proposed transferee district. See 28 U.S.C. §
1404(a). None of the parties argues that venue would not be appropriate in the Middle District of
Pennsylvania and we therefore accept as undisputed that this action could have been brought in
that district. “Once it is determined that a case could have been brought in the proposed
transferee district, a court must weigh a variety of private and public factors to determine
whether the matter should be transferred under 28 U.S.C. § 1404(a).” Swill Beverages, LLC v.
U.S. Distilled Prods. Co., Civ. A. No. 15-5181, 2015 WL 9191470, at *1 (E.D. Pa. Dec. 17,
2015).
The private [factors] include: “plaintiff’s forum preference as manifested in the original choice; the defendant’s preference; whether the claim arose elsewhere; the convenience of the parties as indicated by their relative physical and financial condition; the convenience of the witnesses -- but only to the extent that the witnesses may actually be unavailable for trial in one of the fora; and the location of books and records (similarly limited to the extent that the files could not be produced in the alternative forum).”
The public [factors] include: “[T]he enforceability of the judgment; practical considerations that could make the trial easy, expeditious, or inexpensive; the relative administrative difficulty in the two fora resulting from court congestion; the local interest in deciding local controversies at home; the public policies of the fora; and the familiarity of the trial judge with the applicable state law in diversity cases.”
Thompson, 2016 WL 233702, at *3 (third alteration in original) (quoting Jumara, 55 F.3d at 879-
80).
We first address the private factors. The record before us shows that Plaintiffs’ forum
preference is the Eastern District of Pennsylvania and the DOC Defendants’ preference is the
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Middle District of Pennsylvania. The Third Circuit has instructed that, when we rule on a motion brought pursuant to § 1404, “‘the plaintiff’s choice of venue should not be lightly disturbed.’” Buckeye Pennsauken Terminal LLC v. Dominique Trading Corp., -- F. Supp. 3d --, 2015 WL 9267386, at *3 (E.D. Pa. Dec. 21, 2015) (quoting Jumara, 55 F.3d at 879). “While not dispositive, Plaintiff’s choice of forum is entitled to significant weight.” AT&T Corp. v. PA, Inc., 935 F. Supp. 584, 593 (E.D. Pa. 1996) (citing Jumara, 55 F.3d at 879). Therefore, we conclude that the first two private factors, i.e., the parties’ preferences, when considered together weigh against transferring this action to the Middle District of Pennsylvania.
The DOC Defendants argue that the next two factors support transfer because Plaintiffs’ claims arose in the Middle District of Pennsylvania and trial of this action would be more convenient for the parties in the Middle District. Specifically, Defendants argue that the formulation of the DOC policy relating to the treatment of Hepatitis C took place in the Middle District of Pennsylvania and that several Defendants and two Plaintiffs are located in that district. Defendants also contend, in their Brief, that the fifth and final private factor – the location of records – weighs in favor of transfer because records with respect to the formulation of the DOC’s policy are located in the Middle District. Defendants make no argument with respect to the fourth private factor, the location of witnesses.
Defendants, however, have submitted no “affidavits, depositions, stipulations, or other documents containing facts that would tend to establish the necessary elements for a transfer under 28 U.S.C. § 1404(a).” Argro, 2014 WL 2572804, at *2 (quotation omitted). In the absence of such evidence, we base our analysis of where Plaintiffs’ claims arose and the location of the parties, witnesses and records on the allegations of the Complaint. As we discussed, supra, the Complaint alleges that Maldonado is incarcerated in this District and that decisions
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were made about his treatment for Hepatitis C by Defendants who are also located in this District. (See Compl. ¶¶ 7, 14, 15, 84-85.) The Complaint also alleges that Maldonado has received treatment for his Hepatitis C in the Western District of Pennsylvania and that his appeal of his grievance with respect to his medical treatment was denied in the Middle District of Pennsylvania. (Id. ¶¶ 83, 86.) The Complaint alleges that Chimenti is incarcerated in the Middle District of Pennsylvania, that individuals located in the Middle District of Pennsylvania have made decisions about his medical care, and that he has been treated for his Hepatitis C in the Western District of Pennsylvania. (Id. ¶¶ 52, 59, 61, 63.) The Complaint further alleges that Leyva is incarcerated in the Middle District of Pennsylvania, that he was first diagnosed with Hepatitis C while he was incarcerated in the Western District of Pennsylvania, and that decisions regarding his medical care have been made in the Middle District of Pennsylvania. (Id. ¶¶ 71-72. 77-78.)
We find, based on these allegations, that Plaintiffs’ claims arose in both the Eastern and Middle Districts of Pennsylvania. We conclude that this private factor thus does not favor or disfavor transferring this action to the Middle District of Pennsylvania. We further find, based on the allegations of the Complaint, that there are witnesses who may know of facts relevant to Plaintiffs’ claims who are located in the Eastern, Middle and Western Districts of Pennsylvania. This private factor is thus neutral, not only because witnesses are located in all three districts in this state, but also because the DOC Defendants do not assert that the witnesses who are located outside of this district would be unavailable for trial here. We also infer from the allegations of the Complaint that there are records of Plaintiffs’ medical treatment that are relevant to their claims that are located in all three districts, and Defendants do not argue that any of the records relevant to Plaintiffs’ claims, including those relating to the formation of the DOC’s policy,
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cannot be produced in this district. We thus conclude that this private factor also does not weigh in favor of transferring this action to the Middle District of Pennsylvania. We conclude, based upon Defendants’ assertions, the allegations of the Complaint, and the inferences we may draw from those allegations, and in the absence of any evidence submitted by Defendants in support of their request for transfer, that the private factors as a whole do not support transfer of this action to the Middle District of Pennsylvania.
The DOC Defendants make no argument regarding the public factors. We nonetheless observe any judgment of this Court should be equally enforceable in the Middle District of Pennsylvania, that we have significant local interest in deciding the controversy since one of the Plaintiffs is located in this District, and that we are also aware of no practical considerations that would make trial in this district less easy, expeditious, or inexpensive than trial in the Middle District. Moreover, because the DOC Defendants request an intra-state transfer, both the original and transferee courts are equally familiar with the applicable state law and there are no applicable differences in public policy. Accordingly, we conclude that the public factors also do not weigh in favor of transferring this action to the Middle District of Pennsylvania. We further conclude that the DOC Defendants have not satisfied their burden of establishing the need to transfer this action under § 1404(a). See Thompson, 2016 WL 233702, at *3. We thus deny the DOC Defendants’ request that we transfer this action to the Middle District of Pennsylvania pursuant to § 1404(a). III. THE MEDICAL DEFENDANTS’ MOTION TO DISMISS AND SEVER
Defendants Correct Care Solutions, Dr. Kephart, Dr. Weiner, Andrew Dancha, Dr. John Hochberg, Dr. Nicholas Scharff, Wexford Health Sources, Inc., and Dr. Thomas Lehman, i.e., the Medical Defendants, seek dismissal of all of the claims asserted against them pursuant to
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Rule 12(b)(6) on the ground that the Complaint does not satisfy the pleading standard applicable to civil rights claims. They also move to dismiss the claims against them on the ground that the Complaint does not allege facts that would establish that any of them had personal involvement in the violations of Plaintiffs’ Eighth Amendment rights. The Medical Defendants further move for severance of the Plaintiffs’ claims on the ground that their claims cannot be joined in the same action pursuant to Federal Rule of Civil Procedure 20.
A. The Motion to Dismiss6 1. The appropriate pleading standard
The Medical Defendants argue that the Complaint should be dismissed in its entirety because it fails to plead Plaintiffs’ claims against them with the requisite factual specificity. The Medical Defendants contend that civil rights complaints must be pled with “a higher degree of specificity.” Agresta v. City of Philadelphia, 694 F. Supp. 117, 119-20 (E.D. Pa. 1988) (citing Hall v. Pennsylvania State Police, 570 F.2d 86, 89 (3d Cir. 1978)). The Medical Defendants are, however, incorrect. There are no special pleading standards for civil rights complaints. See Evancho v. Fisher, 423 F.3d 347, 351-52 (3d Cir. 2005) (stating that the heightened pleading standard for civil rights complaints, which was required prior to 1993, no longer applies because, in 1993, the Supreme Court “held that a federal court may not” require a “‘heightened pleading standard -- more stringent than the usual pleading requirement of Rule 8(a) . . . in civil rights cases . . . .’” (quoting Leatherman v. Tarrant Cty. Narcotics Intelligence and Coordination Unit, 507 U.S. 163, 164 (1993))). We therefore deny the Medical Defendants’ Motion to Dismiss as to
6The Medical Defendants Motion to Dismiss purports to seek dismissal of the entire Complaint, but only includes arguments and legal authority concerning § 1983. As Count I is the only Count asserting a claim pursuant to § 1983, we construe the Motion as seeking only dismissal of Count I.
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their argument that the Complaint should be dismissed because it fails to satisfy a heightened pleading standard.
2. Vicarious liability as to the individual Medical Defendants The Medical Defendants have also moved to dismiss Count I of the Complaint as against Kephart, Weiner, Dancha, Hochberg, Scharff and Lehman, on the ground that the Complaint alleges only that they were vicariously liable for the violations of Plaintiffs’ rights and does not allege that they each had personal involvement in any such violations. The Medical Defendants are correct that “[b]ecause vicarious liability is inapplicable to . . . § 1983 suits, a plaintiff must plead that each Government-official defendant, through the official’s own individual actions, has violated the Constitution.”7 Iqbal, 556 U.S. at 676. However, Iqbal did not “abolish[] supervisory liability in its entirety.” Barkes v. First Corr. Med., Inc., 766 F.3d 307, 319 (3d Cir. 2014), overruled on other grounds sub nom. Taylor v. Barkes, -- U.S. --, 135 S. Ct. 2042 (2015). Supervisors “may be liable for unconstitutional acts undertaken by subordinates” in two ways. Id. at 316. “First, liability may attach if they, ‘with deliberate indifference to the consequences, established and maintained a policy, practice or custom which directly caused [the] constitutional harm.’” Id. (alteration in original) (quoting A.M. ex rel. J.M.K. v. Luzerne Cty. Juvenile Det. Ctr., 374 F.3d 572, 586 (3d Cir. 2004)). “Second, ‘a supervisor may be personally liable under § 1983 if he or she participated in violating the plaintiff’s rights, directed others to violate them, or, as the person in charge, had knowledge of and acquiesced in the subordinate’s unconstitutional conduct.’” Id. (quoting A.M., 372 F.3d at 586). The Third Circuit has further explained that, in the first situation, “a state official, by virtue of his or her own deliberate indifference to known deficiencies in a government policy or procedure, has allowed to develop an environment in
7The Medical Defendants do not deny that Kephart, Weiner, Dancha, Hochberg, Scharff, and Lehman are all state actors for purposes of § 1983 liability.
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which there is an unreasonable risk that a constitutional injury will occur, and that such an injury does occur.” Id. at 320. “Liability in such a situation is, as Iqbal requires, imposed not vicariously but based on the supervisor’s own misconduct, because to exhibit deliberate indifference to such a situation is a culpable mental state under the Eighth Amendment.” Id. (citing Starr v. Baca, 652 F.3d 1202, 1207 (9th Cir. 2011)).
As we discussed supra, violation of the Eighth Amendment by deliberate indifference to a prisoner’s serious medical needs “can be shown by [defendant] ‘intentionally denying or delaying access to medical care or intentionally interfering with the treatment once prescribed.’” Rhines, 388 F. App’x at 227 (quoting Estelle, 429 U.S. at 104–05). “A medical need is serious if it ‘has been diagnosed by a physician as requiring treatment or one that is so obvious that a lay person would easily recognize the necessity for a doctor’s attention.’” Id. (quoting Lanzaro, 834 F.2d at 347). Moreover, the medical need must be such that “a failure to treat can be expected to lead to substantial and unnecessary suffering, injury, or death.” Tsakonas, 308 F. App’x at 632.
The Complaint alleges that Kephart “is the Medical Director at SCI Smithfield and is responsible for providing health care to inmates there.” (Compl. ¶ 12.) The Complaint further alleges that, even though Dr. Humar recommended that Chimenti “be assessed with ultrasounds and CT scans of his liver every six months,” Kephart denied Chimenti “the necessary treatment to track and halt the deleterious effects of Hepatitis C, including regular ultrasounds and CT scans, which are medically necessary for individuals with Stage 4 cirrhosis.” (Id. ¶¶ 61-62.) The Complaint also alleges that, even though Chimenti has a MELD score of 12, and Dr. Humar recommended that he be evaluated by a hepatologist regarding the need for a liver transplant if his MELD score exceeded 10, Kephart has failed “to have Mr. Chimenti seen or evaluated by a hepatologist . . . for proper treatment of his liver condition.” (Id. ¶¶ 60-61, 63.) In light of these
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allegations, we conclude that the Complaint plausibly alleges that Kephart personally denied Chimenti access to medical care for his serious medical needs. Accordingly, we further conclude that the Complaint alleges sufficient facts to state a claim that Kephart personally participated in violating Chimenti’s Eighth Amendment rights by acting with deliberate indifference to Chimenti’s serious medical needs. We thus deny the Medical Defendants’ Motion to Dismiss Count I of the Complaint as to Kephart.
The Complaint alleges that “Weiner is the Medical Director at SCI Graterford and is responsible for providing health care to inmates there.” (Id. ¶ 14.) The Complaint further alleges that Maldonado, who has been diagnosed with liver fibrosis between Stage 1 and Stage 2, and who requires immediate treatment of that condition to prevent further liver damage or liver failure, asked Weiner for DAAD treatment and his request was denied. (Id. ¶¶ 83-84, 87.) Construing these allegations in the light most favorable Plaintiffs, we conclude that the Complaint alleges that Weiner personally denied Maldonado access to necessary medical treatment for his serious medical needs. Accordingly, we further conclude that the Complaint alleges sufficient facts to state a claim that Weiner personally participated in violating Maldonado’s Eighth Amendment rights by acting with deliberate indifference to Maldonado’s serious medical needs. We accordingly deny the Medical Defendants’ Motion to Dismiss Count I of the Complaint as to Weiner.
The Complaint alleges that Dancha “is the Regional Medical Director for Correct Care Solutions, and is responsible for overseeing the delivery of medical services in DOC through Correct Care Solution’s Central Region, including SCI Smithfield.” (Id. ¶ 18.) The Complaint alleges that Lehman “was the Medical Director of Wexford Health Source[,]” which was the medical provider for the DOC prior to Correct Care Solutions. (Id. ¶¶ 20-21.) The Complaint
33

further alleges that both Dancha and Lehman “failed with deliberate indifference to have Mr. Chimenti seen or evaluated by a hepatologist or a gastroenterologist for proper treatment of his liver condition.” (Id. ¶ 63.) However, the Complaint does not allege that either Dancha or Lehman had any personal role in the delivery of medical care at SCI Smithfield, were personally aware of Chimenti’s medical condition, or that either Dancha or Lehman “‘intentionally den[ied] or delay[ed] [Chimenti’s] access to medical care or intentionally interfer[ed] with the treatment once prescribed.’” Rhines, 338 F. App’x at 227 (quoting Estelle, 429 U.S. at 104–05). We conclude that the Complaint does not allege that either Dancha or Lehman “participated in violating [Chimenti’s] rights, directed others to violate them, or, as the person in charge, had knowledge of and acquiesced’ in [a] subordinate’s unconstitutional conduct.’” Barkes, 766 F.3d at 319 (quoting A.M., 372 F.3d at 586); see also Lopez v. Corr. Med. Servs., Inc., 499 F. App’x 142, 146 (3d Cir. 2012) (stating that “we have found deliberate indifference to a prisoner’s serious medical needs only where a prison official knows of a prisoner’s need for medical treatment but intentionally refuses to provide it, delays necessary medical treatment for a nonmedical reason, or prevents a prisoner from receiving needed medical treatment” (citing Rouse v. Plantier, 182 F.3d 192, 197 (3d Cir. 1999))). The Complaint also does not allege that either Dancha or Lehman had any involvement in establishing or maintaining any policies, practices, or customs regarding the treatment of Hepatitis C in the DOC inmate population. Consequently, we conclude that the Complaint does not allege that Dancha and Lehman were personally involved in “‘establish[ing] and maintain[ing] a policy, practice or custom which directly caused [the] constitutional harm.’” Barkes, 766 F.3d at 319 (third alteration in original) (quoting A.M., 372 F.3d at 586). We further conclude, accordingly, that the Complaint does not allege sufficient facts to plausibly state § 1983 claims against Dancha and Lehman for violating Chimenti’s
34

Eighth Amendment rights by acting with deliberate indifference to Chimenti’s serious medical needs. We thus grant the Medical Defendants’ Motion to Dismiss Count I of the Complaint as to Dancha and Lehman.
The Complaint alleges that Hochberg “is the Assistant Medical Director for Correct Care Solutions’ Regional Office, and is responsible for overseeing the delivery of medical services in DOC through Correct Care Solution’s Central Region.” (Compl. ¶ 19.) The Complaint alleges that Scharff “is the Medical Director for Correct Care Solutions in Pennsylvania, and in that capacity is responsible for providing adequate medical care of Plaintiffs and those similarly situated.” (Id. ¶ 17.) The Complaint does not allege that either Hochberg or Scharff were personally aware of the medical conditions of any of the Plaintiffs or that either of them had any personal involvement in the medical treatment of, or denial of treatment to, any of the Plaintiffs. The Complaint also does not allege that either Hochberg or Scharff had any involvement in establishing or maintaining any policies, practices, or customs regarding the treatment of Hepatitis C in the DOC inmate population. We conclude, accordingly, that the Complaint does not allege sufficient facts to state a plausible § 1983 claim against either Hochberg or Scharff for violating the Eighth Amendment rights of any of the Plaintiffs by acting with deliberate indifference to the serious medical needs of any of the Plaintiffs. See Lopez, 499 F. App’x at 146 (citing Rouse, 182 F.3d at 197); see also Barkes, 766 F.3d at 319 (quoting A.M., 372 F.3d at 586). We consequently grant the Medical Defendants’ Motion to Dismiss Count I of the Complaint as to Hochberg and Scharff.
3. Vicarious Liability as to Correct Care Solutions and Wexford Health Sources, Inc._________________________________________________
The Medical Defendants have also moved to dismiss Count I of the Complaint as against the corporate Medical Defendants, Correct Care Solutions and Wexford Health Sources, Inc., on
35

the ground that the Complaint alleges only that they were vicariously liable for the violation of Plaintiffs’ rights and does not allege that these corporations maintained policies that directly caused Plaintiffs’ injuries. However, contrary to the Medical Defendants apparent understanding, Wexford Health Sources, Inc. is not named as a Defendant in Count I of the Complaint.8 As we cannot dismiss a claim that does not exist, we deny the Motion to Dismiss Count I of the Complaint as to Wexford Health Sources, Inc., and we analyze the Medical Defendants’ argument only as to Correct Care Solutions.
It is well settled that a municipal entity cannot be sued under § 1983 for the constitutional torts of its employees. See Monell v. Dep’t of Soc. Servs., 436 U.S. 658, 691 (1978). This rule has been extended to private corporations operating under a contract with the state. See Natale v. Camden Cty. Corr. Facility, 318 F.3d 575, 583-84 (3d Cir. 2003). Indeed, the Third Circuit has made it clear that a private company that provides medical services to inmates at state facilities “‘cannot be held responsible for the acts of its employees under a theory of respondeat superior or vicarious liability.’” Sims v. Wexford Health Sources, -- F. App’x --, 2015 WL 9267942, at *2 (3d Cir. 2015) (quoting Natale, 318 F.3d at 583). Therefore, in order to state a § 1983 claim against Correct Care Solutions, the Complaint must allege “facts to state a claim that [Correct Care Solutions] had a policy, custom, or practice, and that the policy, custom, or practice caused the constitutional violation at issue.” Id. (citing Natale, 318 F.3d at 583-84). See also Stankowski v. Farley, 251 F. App’x 743, 748 (3d Cir. 2007) (stating that a private corporation providing medical care inside a prison may not be held liable for the “constitutional violations committed by its employees, unless [it] has adopted a policy, practice or custom that caused the constitutional violations alleged.” (citing Monell, 436 U.S. at 690; Woodward v. Corr. Med.
8Wexford Health Sources, Inc. is named as a Defendant only as to Count IV of the Complaint, which alleges a claim against it for medical malpractice.
36

Servs., 368 F.3d 917, 927 (7th Cir. 2004))); and see Ozoroski v. Maue, 460 F. App’x 94, 97-98 (3d Cir. 2012) (“To establish Eighth Amendment liability against a private employer . . . the prisoner must ‘provide evidence that there was a relevant [corporate] policy or custom . . . that . . . caused the constitutional violation [he] allege[s]’” (second through fifth alterations in original) (quoting Natale 318 F.3d at 584)).
The Complaint does not allege that Correct Care Solutions established a corporate policy or had a corporate practice or custom with respect to the provision of DAADs to inmates with Hepatitis C. The Complaint also does not allege that any such policy, custom, or practice of Correct Care Solutions caused the violations of Plaintiffs’ Eighth Amendment rights. We therefore conclude that the Complaint does not allege sufficient facts to state a plausible § 1983 claim against Correct Care Solutions for deliberate indifference to Plaintiffs’ serious medical needs in violation of the Eighth Amendment and we grant the Medical Defendants’ Motion to Dismiss Count I of the Complaint as against Correct Care Solutions on this basis.
In summary, we deny the Medical Defendants’ Motion to Dismiss Count I of the Complaint as to Kephart, Weiner, and Wexford Health Sources, Inc., and grant it as to Dancha, Hochberg, Scharff, Lehman and Correct Care Solutions. Count I is thus dismissed as against Dancha, Hochberg, Scharff, Lehman and Correct Care Solutions.9 To the extent that the Medical Defendants may have intended to move to dismiss Counts II through IV of the Complaint pursuant to Rule 12(b)(6) because those counts allege only vicarious liability on the part of the Medical Defendants, we deny the Motion because the Medical Defendants have cited no authority to support the proposition that they cannot be held vicariously liable for violations of Article 1, § 13 of the Pennsylvania Constitution or for medical malpractice.
9We need not dismiss Count I as to Wexford Health Sources because, as explained supra, Wexford Health Sources is not named as a Defendant in that Count.
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B. Motion to Sever The Medical Defendants also contend that we should sever Plaintiffs’ claims from one another because they do not satisfy the requirements for permissive joinder pursuant to Federal Rule of Civil Procedure 20. Rule 20 provides that “[p]ersons may join in one action as plaintiffs if: (A) they assert any right to relief jointly, severally, or in the alternative with respect to or arising out of the same transaction, occurrence, or series of transactions or occurrences; and (B) any question of law or fact common to all plaintiffs will arise in the action.” Fed. R. Civ. P. 20(a)(1). Federal Rule of Civil Procedure 21 provides that, if parties have been misjoined, we “may at any time, on just terms, add or drop a party.” Fed. R. Civ. P. 21. The Medical Defendants argue that Plaintiffs’ claims must be severed because none of the elements required by Rule 20(a)(1) are present in this case since the three Plaintiffs have very different medical conditions, have been treated by different medical personnel, and do not claim that they were harmed as a result of their own participation in a joint enterprise. “‘A district court has broad discretion in deciding whether to sever a party pursuant to Federal Rule of Civil Procedure 21.’” Cooper v. Fitzgerald, 266 F.R.D. 86, 88 (E.D. Pa. 2010) (quoting Boyer v. Johnson Matthey, Inc., Civ. A. No. 02–8382, 2004 WL 835082, at *1 (E.D. Pa. Apr. 16, 2004)). “For courts applying Rule 20 and related rules, ‘the impulse is toward entertaining the broadest possible scope of action consistent with fairness to the parties; joinder of claims, parties and remedies is strongly encouraged.’” Hagan v. Rogers, 570 F.3d 146, 153 (3d Cir. 2009) (quoting United Mine Workers v. Gibbs, 383 U.S. 715, 724 (1966)). “Rule 20 permits ‘the joinder of a person who has some interest in an action . . ., even when that interest is not so strong as to require his joinder’ under Rule 19.” Id. (alteration in original) (quoting Field v. Volkswagenwerk AG, 626 F.2d 293, 299 (3d Cir. 1980)).
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“The first element of Rule 20(a), the ‘same transaction’ or transactional relatedness prong, refers to the similarity in the factual background of the relevant claims.” Cooper, 266 F.R.D. at 88 (citing Coughlin v. Rogers, 130 F.3d 1348, 1350 (9th Cir. 1997)). “‘Courts generally apply a case-by-case approach when considering whether the facts of several claims constitute a single transaction or occurrence, or a series of transactions or occurrences.’” Id. (quoting Lopez v. City of Irvington, Civ. A. No. 05-5323, 2008 WL 565776, at *2 (D.N.J. Feb. 28, 2008)). “Significantly, ‘[t]ransaction is a word of flexible meaning, which may comprehend a series of many occurrences, depending not so much upon the immediateness of their connection, as upon their logical relationship.’” Id. (alteration in original) (quoting Al Daraji v. Monica, Civ. A. No. 07-1749, 2007 WL 2994608, at *8 (E.D. Pa. Oct. 21, 2007)). “In determining whether a logical relationship exists between claims, the Third Circuit has stated that courts must engage in ‘a detailed analysis . . . to determine whether the claims involve: (1) many of the same factual issues; (2) the same factual and legal issues; or (3) offshoots of the same basic controversy between the parties.’” Russell v. Chesapeake Appalachia, L.L.C., 305 F.R.D. 78, 81 (M.D. Pa. 2015) (alteration in original) (quoting Xerox Corp. v. SCM Corp., 576 F.2d 1057, 1059 (3d Cir. 1978)).
The Plaintiffs’ claims in this case all involve the same alleged DOC policy and practice to “den[y] necessary medical care for inmates diagnosed with Hepatitis C viral infections, thereby placing them at substantial and unnecessary risk for severe illness, injury and death.” (Compl. ¶ 1.) The Complaint alleges that all three of the Plaintiffs, who are inmates in State Correctional Institutions run by the DOC, have Hepatitis C and suffer from “serious health complications” arising from their Hepatitis C infections. (Id. ¶ 2.) The Complaint further alleges that Correct Care Solutions is the current health care provider for all State Correctional
39

Institutions run by the DOC and that Wexford Health Sources, Inc. was the previous health care provider for those institutions. (Id. ¶¶ 16, 20.) The Complaint also alleges that, notwithstanding Plaintiffs’ serious medical conditions, “the DOC and other Defendants have refused to provide medical treatment to Plaintiffs and others incarcerated in the DOC with Hepatitis C infections that is consistent with current and prevailing medical standards.” (Id. ¶ 2.) Plaintiffs have brought claims arising from the Defendants’ alleged denial of the appropriate medical treatment for their serious medical conditions for violation of their rights under the Eighth Amendment and the Pennsylvania Constitution and for medical malpractice. We conclude that all three Plaintiffs’ claims will involve many of the same factual and legal issues regarding the existence of the DOC’s policy to deny medical care, whether said policy actually resulted in the denial of medical care to Plaintiffs and, if so, whether that denial of medical care amounted to medical malpractice and/or a violation of Plaintiffs’ rights under the Eighth Amendment. Consequently, a logical relationship exists between the claims raised by all three Plaintiffs such that the first prong of Rule 20(a)(1) is satisfied. This relationship also satisfies the second prong of Rule 20(a)(1). See Garcia v. Brock-Weinstein, Civ. A. No. 13-7487, 2014 WL 2957487, at *2 (E.D. Pa. July 1, 2014) (“‘The thing which makes the relationship logical is some nucleus of operative facts or law -- the second prong of the 20(a) test.’” (quoting Hanley v. First Investors Corp., 151 F.R.D. 76, 79 (E.D. Tex. 1993))). We conclude, accordingly, that the Plaintiffs’ claims satisfy the requirements for permissive joinder pursuant to Rule 20 and thus have not been misjoined in this lawsuit. Consequently, we deny the Medical Defendants’ Motion to Sever their claims. IV. CONCLUSION
For the foregoing reasons, the Motions to Dismiss are granted in part and denied in part as follows. The DOC Defendants’ Motion to Dismiss as to Count I of the Complaint is granted
40

as to Noel and the § 1983 claim asserted in that Count is dismissed as to Noel. The DOC Defendants’ Motion to Dismiss as to Count I of the Complaint is denied as to Wetzel, Dreibelbis, and Korszniak. The DOC Defendants’ Motion to Dismiss as to Count II of the Complaint is denied. The DOC Defendants’ Motion to Dismiss as to Count III of the Complaint is granted as to Wetzel and denied as to the DOC, Noel, Oppman, and Dreibelbis. The DOC Defendants’ Motion to Dismiss is also denied as to their argument that venue is improper in this district and we further deny their request that we transfer this case to the Middle District of Pennsylvania.
The Medical Defendants’ Motion to Dismiss as to Count I of the Complaint is granted as to Dancha, Hochberg, Scharff, Lehman and Correct Care Solutions and is denied as to Kephart, Weiner, and Wexford Health Source, Inc. The Medical Defendants’ Motion to Dismiss and Sever is denied in all other respects.
An appropriate order follows.
BY THE COURT: /s/John R. Padova ____________________________ John R. Padova, J.
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 Case 2:15-cv-03333-JP Document 101 Filed 11/02/17 Page 1 of 43

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

SALVATORE CHIMENTI, DANIEL

:

LEYVA, DAVID MALDONADO, and all

:

others similarly situated,

:

:

Plaintiffs,

:

:

v.

:

:

PENNSYLVANIA DEPARTMENT OF

:

CORRECTIONS; JOHN WETZEL, Secretary, :

Pennsylvania Department of Corrections;

:

PAUL NOEL, Chief Medical Director,

:

Pennsylvania Department of Corrections;

:

RICH WENHOLD, Infection Control

:

Coordinator, Pennsylvania Department of

:

Corrections; CORRECT CARE SOLUTIONS; :

DR. JAY COWAN, Medical Director, Correct :

Care Solutions; DR. JOHN KEPHART, Medical :

Director (former), SCI Smithfield; DR. JAMES :

FROMMER, Medical Director, SCI Smithfield; :

WEXFORD HEALTH SOURCES, INC.

:

:

Defendants

:

Civil Action No. 15-3333
Judge John R. Padova (Filed via ECF)

PLAINTIFFS’ RESPONSE TO DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT

Defendants Wetzel and Noel have filed a Motion for Summary Judgment on all claims set forth in Plaintiffs’ First Amended Complaint. Under settled standards governing Rule 56 of the Federal Rules of Civil Procedure, the motion must be denied. First, defendants’ arguments on mootness and standing have been expressly rejected by the Supreme Court and the Third Circuit Court of Appeals. Second, there are material issues of fact that preclude summary judgment. Plaintiffs’ arguments are fully set forth in the accompanying Memorandum of Law.

Case 2:15-cv-03333-JP Document 101 Filed 11/02/17 Page 2 of 43

Date: November 2, 2017

Respectfully Submitted,
/s/ David Rudovsky David Rudovsky, PA Attorney No. 15168 Kairys, Rudovsky, Messing, Feinberg & Lin LLP 718 Arch Street, Suite 501S Philadelphia, PA 19106 (215) 925-4400
/s/ Su Ming Yeh Su Ming Yeh, PA Attorney No. 95111 Angus R. Love, PA Attorney No. 22392 Pennsylvania Institutional Law Project 718 Arch Street, Suite 304S Philadelphia, PA 19106 (215) 925-2966
/s/ Stephen D. Brown Stephen D. Brown, PA Attorney No. 27829 Christine Levin, PA Attorney No. 27829 Rose Marie Wong, PA Attorney No. 320602 Dechert LLP Cira Centre 2929 Arch Street Philadelphia, PA 19104 (215) 994-2404

Case 2:15-cv-03333-JP Document 101 Filed 11/02/17 Page 3 of 43

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

SALVATORE CHIMENTI, DANIEL

:

LEYVA, DAVID MALDONADO, and all

:

others similarly situated,

:

:

Plaintiffs,

:

:

v.

:

:

PENNSYLVANIA DEPARTMENT OF

:

CORRECTIONS; JOHN WETZEL, Secretary, :

Pennsylvania Department of Corrections;

:

PAUL NOEL, Chief Medical Director,

:

Pennsylvania Department of Corrections;

:

RICH WENHOLD, Infection Control

:

Coordinator, Pennsylvania Department of

:

Corrections; CORRECT CARE SOLUTIONS; :

DR. JAY COWAN, Medical Director, Correct :

Care Solutions; DR. JOHN KEPHART, Medical :

Director (former), SCI Smithfield; DR. JAMES :

FROMMER, Medical Director, SCI Smithfield; :

WEXFORD HEALTH SOURCES, INC.

:

:

Defendants.

:

Civil Action No. 15-3333
Judge John R. Padova (Filed via ECF)

PLAINTIFFS’ MEMORANDUM OF LAW IN RESPONSE TO MOTION FOR SUMMARY JUDGMENT INTRODUCTION
Thousands of inmates with Chronic Hepatitis C are systematically denied medical treatment by the Pennsylvania Department of Corrections (“DOC”), which follows an unconstitutional policy and practice of refusing over 95% of inmates with Chronic Hepatitis C necessary medical treatment with Direct Acting Anti-Viral (“DAA”) drugs. As a result of this policy, this class of DOC inmates suffers from pain, fatigue, depression, and the risk of liver failure, liver cancer, and other severe illness and death.

1

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DAAs, which are recommended by every relevant major medical association and approved by the Food & Drug Administration, provide a full cure for Hepatitis C and would protect those infected from substantial pain and from the risk of the severe consequences of nontreatment. The DOC can provide medical treatment that will cure nearly all of its inmates suffering from Chronic Hepatitis C -- treatment to which they are constitutionally entitled under the current, well-established Eighth Amendment medical community standard of care. Nonetheless, the DOC impermissibly rations DAAs and refuses to provide necessary DAA treatment to the overwhelming majority of DOC inmates with Chronic Hepatitis C.
This lawsuit seeks injunctive relief under Rule 23(b)(2) F.R. Civ. P., on behalf of a class that includes thousands of prisoners subject to the DOC’s unconstitutional medical policy. It also seeks damages on behalf of plaintiff Chimenti. Plaintiffs sought Rule 23(b)(2) class certification in their original Class Action Complaint, in the First Amended Class Action Complaint, and by way of Motions for Class Certification filed contemporaneously with the filing of the original Complaint in 2015, and again on October 2, 2017, on behalf of a class of individuals with Chronic Hepatitis C. See Pls.’ First Am. Class Action Compl. (Doc. No. 50) (“Am. Compl.”); Plaintiffs’ Motion for Class Certification (Doc. No. 2); Plaintiffs’ Renewed Motion for Class Certification (Doc. No. 94).1
Defendants Wetzel and Noel have filed a Motion for Summary Judgment, arguing that (1) plaintiffs lack standing to sue and that their claims are moot, (2) the DOC policy and practices do not violate the Eighth Amendment, (3) plaintiffs have not stated a claim under the Pennsylvania Constitution, and (4) plaintiff Chimenti’s claim for damages should be dismissed
1 The first Motion for Class Certification was held in abeyance without prejudice, to permit the parties to engage in discovery on the issues presented by that Motion. On October 2, 2017, plaintiffs filed the renewed Motion for Class Certification. (See Docket No. 94).
2

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on qualified immunity grounds. As we now show, all of these arguments are without merit and this Court should deny the Motion. I. RULE 56 STANDARDS FOR SUMMARY JUDGMENT
A court may grant summary judgment only if “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). A genuine issue of material fact exists if “the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A factual dispute is material when it “might affect the outcome of the suit under the governing law.” Id. In deciding the motion, the Court must “view the record in the light most favorable to the non-moving party and draw all reasonable inferences in that party’s favor.” Thomas v. Cumberland Cty., 749 F.3d 217, 222 (3d Cir. 2014) (citing Bowers v. Nat’l Collegiate Athletic Ass’n, 475 F.3d 524, 535 (3d Cir. 2007)). This standard means that “a district court may not make credibility determinations or engage in any weighing of the evidence; instead, the non-moving party’s evidence is to be believed, and all justifiable inferences are to be drawn in [her] favor.” Montone v. City of Jersey City, 709 F.3d 181, 191 (3d Cir. 2013) (quoting Marino v. Indus. Crafting Co., 358 F.3d 241, 247 (3d Cir. 2004)) (internal quotations and alterations omitted); see also Ross v. Gilhuly, 755 F.3d 185, 191 n.9 (3d Cir. 2014). “A motion for summary judgment is properly denied if ‘a fairminded jury could return a verdict for the plaintiff on the evidence presented.’” Thomas, 749 F.3d at 222 (quoting Anderson, 477 U.S. at 252).
Under these standards, defendants’ arguments are without merit. First, as a matter of law, the defendants’ assertions as to lack of standing and mootness of the plaintiffs’ claims are directly foreclosed by binding authority (entirely ignored in Defendants’ Memorandum of Law)
3

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from the U.S. Supreme Court and the Third Circuit Court of Appeals. Second, in violation of the cardinal principle of summary judgment, the defendants fail to view the facts in the light most favorable to the plaintiffs and instead base their arguments on material facts that are in dispute.2 On every relevant factor under the Eighth Amendment’s deliberate indifference standard, certain undisputed facts favor the plaintiffs or there are disputed material facts that must be resolved by trial. Third, plaintiffs’ claim for relief under the Pennsylvania Constitution states a valid basis for relief under state law and plaintiff Chimenti’s individual damage claim presents sufficient evident on the issue of causation such that it should not be dismissed. II. FACTUAL BACKGROUND3
A. The Hepatitis C Epidemic Hepatitis C is a viral infection that attacks the liver and causes hepatitis, or liver inflammation. Am. Compl. at ¶ 17; see also Mayo Clinic Staff, Hepatitis C Overview, MAYO CLINIC, http://www.mayoclinic.org/diseases-conditions/hepatitis-c/home/ovc-20207365 (last visited Sep. 25, 2017; Hepatitis C Fact Sheet, World Health Organization, http://www.who.int/mediacentre/factsheets/fs164/en/ (last updated July 2017). Hepatitis C can significantly impair the liver’s ability to assist the body in digesting essential nutrients, filtering toxins from the blood, and preventing disease. Am. Compl. at ¶ 17. There are multiple genotypes of Hepatitis C infections, which can be of an acute or chronic nature. Id. at ¶ 18. An acute infection occurs within the first six months of exposure to the virus and, for most of those
2 As noted in Plaintiffs’ Response to Defendants’ Statement of Facts, defendants failed to adhere to this Court’s procedure requiring the moving party to confer with the opposing party and submitting a joint statement of undisputed facts. 3 Facts that are specific to the arguments presented by the defendants are set forth in the corresponding argument sections of this Memorandum of Law.
4

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infected, leads to chronic Hepatitis C infection. Id. Chronic Hepatitis C infections are serious, long-term illnesses that can last throughout a person’s life. Id. at ¶ 19.
Hepatitis C infections are spread by transmitting blood from a person infected with Hepatitis C to another person. See Report of Dr. Stacey Trooskin (“Trooskin Rep.”), Exhibit (Ex.) A at 2. Some of the major means of transmission are the sharing of needles for injecting drugs, tattooing or piercing, being born to a mother with Hepatitis C, transfusion with infected blood or blood products, and sexual contact with a person infected with Hepatitis C. Id. Any delay in treatment or rationing of DAAs for treatment “cannot be justified on any medical basis” because each day without treatment increases the risk of transmitting Hepatitis C to others and increases the likelihood of developing more serious medical problems. Id. at 4-5.
Hepatitis C is the leading cause of cirrhosis (the irreversible scarring of liver tissue that can cause symptoms such as swelling, increased likelihood of bruising, jaundice, itching, nausea, and problems with concentration and memory) and liver cancer, making it the most common cause of liver transplants. Id. Liver transplants are painful, carry a risk of significant complications, and are nearly impossible for prisoners to obtain. Am. Compl. at ¶ 21. They also result in lower recovery rates than treatment with DAA drugs and are very costly. Id.
Chronic Hepatitis C infections can also cause serious chronic liver disease, liver fibrosis (the scarring of liver tissue), extrahepatic conditions (such as diabetes, muscle damage, nerve damage, heart disease, fatigue, depression, nausea, and problems with concentration and memory), and death. Am. Compl. at ¶ 19. More than 20,000 people die each year as a result of Hepatitis C -- more than any other infectious disease. See Trooskin Rep. Ex. A, 2.
B. Current Standard of Care for Hepatitis C Infections For many years, finding and establishing an effective and safe treatment for Hepatitis C infections was a highly elusive goal. Id.; Am. Compl. at ¶ 23. The standard treatment, which
5

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included the use of interferon and ribavirin medications, failed to cure large numbers of patients and was associated with pain and other adverse side-effects, including psychiatric and autoimmune disorders, flu-like symptoms, and gastrointestinal distress. Am. Compl. at ¶ 23. Over the past four years, the approval by the FDA of new DAAs has greatly improved the treatment module for Hepatitis C infections. Id. at ¶ 24.
Beginning in 2011, the FDA approved the use of several “breakthrough therapies” in the form of DAA medications that can cure Hepatitis C: Harvoni® (ledipasvir-sofosbuvir), Olysio® (simeprevir), Sovaldi® (sofosbuvir), Viekira Pak® (ombitasvir/paritaprevir/ritonavir plus dasabuvir), Zepatier® (elbasvir/grazoprevir), and Epclusa® (Sofosbuvir/Velpatasvir).4 Trooskin Rep., Ex. A, 3. These treatments cause a sustained biologic response that completely cures more than 90% of patients treated with DAAs. Id. Over 95% of individuals with Hepatitis C treated with Harvoni are now cured of the infection. Id. Individuals treated with these DAAs suffer no, or minimal, side effects. Id.; Am. Compl. at ¶ 25.
The standard of care in the community for Hepatitis C infections is treatment of all individuals infected with chronic Hepatitis C with DAAs, regardless of the stage of the disease. The leading liver disease and Hepatitis C treatment medical organizations, the American Association for the Study of Liver Diseases (“AASLD”) and the Infectious Diseases Society of
4 Defendants’ medical expert, Dr. Newton Kendig, has correctly termed the FDA’s recent approval of a new DAA as a “game changer” in terms of effective treatment at a greatly reduced cost. See Newton Kendig Dep. Ex. B at p. 138. Specifically, the FDA has recently approved Mavyret, which is market priced at 40% the price of other DAAs. See Max Nisen, AbbVie Wages HCV Drug-Price War on Gilead, BLOOMBERGGADFLY, https://www.bloomberg.com/gadfly/articles/2017-08-07/abbvie-mavyret-price-threatensgilead-hepatitis-dominance (Aug. 7, 2017 8:00 AM) (“AbbVie's $13,200 monthly price for Mavyret looks like a stunning discount to the roughly $31,500 per month Gilead charges for its best-selling Harvoni.”); Reuters Staff, FDA Approves AbbVie’s Hepatitis C Drug, REUTERS, https://www.reuters.com/article/us-abbvie-fda/fda-approves-abbvies-hepatitis-c-drugidUSKBN1AJ2SE (Aug. 3, 2017 4:03 PM).
6

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America (“IDSA”), have recommended that DAAs be used to treat all individuals with chronic Hepatitis C and have specifically confirmed that treatment should not be reserved for individuals with advanced states of the infection. Trooskin Rep., Ex. A, 3; see When and in Whom to Initiate HCV Therapy, AASLD AND IDSA HCV GUIDANCE, http://www.hcvguidelines.org/evaluate/when-whom (last updated Sep. 21, 2017), Ex. C. “Rather, the standard of care is to treat all patients with chronic [Hepatitis C] infection, except those with short life expectancies who cannot by remediated by [DAAs], by transplantation, or be other directed therapy.” Trooskin Rep., Ex. A, 3.5
Several other institutions have also recommended or instituted this course of treatment, further establishing the use of DAAs as the standard of care for chronic Hepatitis C, including the Center for Disease Control (“CDC”), Medicare, and the Veterans Administration (“VA”). Id. These institutions -- particularly the AASLD, IDSA, CDC, and VA -- are the same institutions the DOC’s medical provider relies on for treatment recommendations. Cowan Dep. Ex. D at 16-19, 24-25. Yet, the DOC has not implemented the standard of care that these
5 A federal court recently recognized the AASLD as “the leading organization of doctors and specialists on the study of liver disease in the United States,” In re Tylenol (Acetaminophen) Mktg.,Sales Practices, & Prod. Liab. Litig., 198 F. Supp. 446, 454 n.19 (E.D. Pa. 2016), with a “stated mission . . . [t]o advance and disseminate the science and practice of hepatology, and to promote liver health and quality patient care.” In re Tylenol (Acetaminophen) Mktg., Sales Practices, & Prod. Liab. Litig., 181 F. Supp. 3d 278, 313 (E.D. Pa. 2016) (internal citations omitted). Similarly, the IDSA has been recognized as “represent[ing] nearly 10,000 physicians and scientists devoted to patient care, education, research, and public health in infectious diseases” and as “the nation’s foremost professional organization[] [for] infectious diseases.” Cent. Rabbinical Cong. of U.S. & Canada v. N.Y.C. Dep’t of Health & Mental Hygiene, No. 12 CIV. 7590 NRB, 2013 WL 126399, at *10, *16 (S.D.N.Y. Jan. 10, 2013), vacated and remanded, 763 F.3d 183 (2d Cir. 2014); see also Ekendahl v. La. Med. Mut. Ins. Co., 124 So.3d 461, 465 (La. Ct. App. 2013) (describing IDSA as “the major and most authoritative organization for infectious disease physicians”). 7

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organizations all recognize -- the use of DAAs to treat all individuals diagnosed with chronic Hepatitis C.
C. Current Pennsylvania DOC Policy for HCV Infections At the time when plaintiffs filed their Class Action Complaint on June 12, 2015, the Defendants had ceased all medical treatment for Hepatitis C, providing neither the previous triple therapy (boceprevir or telaprevir with interferon) nor DAAs, and had no policy for treating any inmate diagnosed with chronic Hepatitis C with DAAs. See Class Action Compl. (Docket No. 1) at 6-11. Rather, inmates facing severe health consequences as a result of the infection were simply told that the “DOC/BHCS is re-evaluating [their] treatment protocol for Hepatitis C given the new guidance issued by the [AASLD] and the [IDSA].” Id. at 11; Letter to Daniel Leyva from Christopher Oppman (“Leyva Letter”), Ex. E at 1; Letter to David Maldonado from Christopher Oppman (“Maldonado Letter”), Ex. F at 1. On November 20, 2015, defendants adopted an interim policy, see Ex. P, and then on November 7, 2016, adopted a policy for treating patients with chronic Hepatitis C (“Hepatitis C Protocol” or “Protocol”) that applies to all inmates diagnosed with chronic Hepatitis C. See “DOC Access to Health Care Procedures Manual, Section 20 – Hepatitis C Protocol,” (Nov. 7, 2016) (“Hepatitis C Protocol”), Ex. G. This policy provides the “clinical guidelines for the diagnosis, management, and treatment of inmate patients with chronic Hepatitis C,” id. at 20-1, and therefore is highly consequential on the decision to provide or not to provide DAA treatment. The class members seek injunctive relief against defendants on the ground that the Hepatitis C Protocol fails to meet the current standard of care for Hepatitis C treatment.6
6 As we discuss in detail below, infra 16-18, the Hepatitis C Protocol does not moot plaintiffs’ case because, as the history of this case shows, the Hepatitis C Protocol is subject to change at 8

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Individuals with chronic Hepatitis C are diagnosed on a fibrosis level scale of F-0 to F-4, with the F-4 diagnosis as the most serious stage of the infection. Am. Compl. ¶ 31. As the Amended Complaint alleges, and the record now shows, individuals at early stages of Chronic Hepatitis C often suffer from serious physical and mental symptoms, and, without treatment, most of them will progress to high fibrosis levels. Id. at ¶¶ 31-32.
The Hepatitis C Protocol purports to prioritize treatment according to the seriousness of the condition, and the DOC claims that it is currently providing DAA treatment to all inmates at F-3 or F-4. Noel Dep. Ex. H, 104-105. But even if that is true, neither the Protocol nor DOC practice mandates or otherwise ensures that such treatment will continue in the future. The record is clear that from the time the DOC had no policy, to an interim policy, to the current Protocol, that decisions to treat or not treat have been and will continue to be made on the basis of non-medical factors such as budget priorities and so-called administrative limitations. See infra Section IV(B)(2). Similarly, defendants’ assertion that they will soon begin treating inmates at stage F-2 fibrosis is not binding and is at best an aspiration that could easily be derailed by non-medical factors. What is not in dispute is that inmates at stage F-2 are not currently being treated and that the defendants have no plans to treat those at F-0 or F-1, even though inmates at these stages have over a 70% chance of progressing to serious fibrosis and constitute the largest part of the class of the approximate 5,500 diagnosed inmates. See Trooskin Rep., Ex. A, 2; Cowan Dep. Ex. D, 12; Decl. of Richard Wenhold, Ex. I. Currently, the DOC treats approximately 5% of the inmates diagnosed with Hepatitis C. Declaration of Richard Wenhold, Ex. I. Defendants’ failure to provide treatment to thousands of inmates not
any time. See, e.g., Knox v. Serv. Emps. Int’l. Union, Local 1000, 567 U.S. 298, 307-08 (2012) (holding that voluntary changes do not moot claim; case is moot only when it is impossible for court to grant any effectual relief.).
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Case 2:15-cv-03333-JP Document 101 Filed 11/02/17 Page 12 of 43 only subjects them to current pain and injury, but also to the risk of more severe health complications, including liver failure, cancer, and death. Trooskin Rep. Ex. A, 4-6; Trooskin Dep., Ex. J, 47-50.
The Hepatitis C Protocol is implemented by the Hepatitis C Treatment Committee, which consists of the DOC Bureau of Health Care Services Chief of Clinical Services, the Statewide Medical Director for the medical vendor (currently Correct Care Solutions), and the Bureau of Health Care Services Infection Control Coordinator. See Hepatitis C Protocol, Ex. G, 20-10; Noel Dep. Ex. H, 18. The Chief of Clinical Services, currently Dr. Noel, is a final decision-maker in authorizing DAA treatment for any particular inmate. Noel Dep., Ex. H, 187. He consults with the medical contractor’s medical director (then Dr. Cowan) in determining whether to authorize treatment for a particular inmate. The other member of the Hepatitis C committee, Mr. Wenhold, is concerned solely with administrative matters and does not provide any input into treatment decisions. Id. at 153-54.
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III. ARGUMENT A. The Plaintiffs Have Standing to Seek Injunctive Relief on Their Constitutional Claims and None of the Claims are Moot. Defendants’ first and major contention on summary judgment is that plaintiffs lack
standing to seek prospective injunctive relief because one is no longer in the DOC (Maldonado), one has already received DAA treatment (Chimenti), and one has allegedly failed to fully exhaust administrative remedies (Leyva). Not only are the defendants wrong in asserting that plaintiff Leyva did not exhaust administrative remedies7 (see Plaintiff’s Counterstatement of Facts), but there is no need to delve into the factual questions of exhaustion, treatment, or release from the DOC since the defendants concede that at least two of the named plaintiffs, Chimenti and Maldonado, had standing to sue at the time of the filing of the Class Action Complaint on June 12, 2015. Under controlling law in the United States Supreme Court and the Third Circuit—none of which is cited or discussed by the defendants—where a plaintiff has standing at the initiation of a class action law suit, and where the claims are inherently transitory, standing for class representation and class certification is not lost, and the claims do not become moot if the named plaintiff is either granted the relief sought or because of other changed circumstances that deprive the plaintiff of standing to pursue his individual claims.
In the circumstances of this case, plaintiffs’ standing to sue as class representatives relates back to the date of the filing of the Complaint or filing of the first motion for class certification. See Parole Comm’n v. Geraghty, 445 U.S. 388, 404 (1980) (holding that “an
7 Daniel Leyva’s initial grievance seeking DAA treatment was “upheld.” See Leyva grievances, Ex. V. Once a grievance has been granted or upheld, there is no need to appeal the grievance. Diaz v. Palakovich, 2001 WL 4867549, *4 (3d Cir. Oct. 14, 2011) (holding that there is no need to appeal outcomes of “grievance resolved” or “uphold inmate”).
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action brought on behalf of a class does not become moot upon expiration of the named plaintiff’s claim”); Gerstein v. Pugh, 420 U.S. 103, 110 n.11 (1975) (holding that termination of a class representative’s claim did not moot the claims of unnamed class members); Sosna v. Iowa, 419 U.S. 393, 399–401 (1975) (same); see also Gayle v. Warden Monmouth Cty. Corr. Inst., 838 F.3d 297, 305 (3d Cir. 2016) (“[C]lass claims can breathe life into an otherwise moot case for they ‘allow a plaintiff to continue seeking class certification in certain circumstances even though his individual claim for relief has become moot.’”) (quoting Richardson v. Bledsoe, 829 F.3d 273, 279 (3d Cir. 2016)).
The Supreme Court has repeatedly held that where federal class-action plaintiffs will not be in a system they are challenging in a class action, they can continue to litigate their claims by virtue of the “inherently transitory” exception. In Geraghty, the plaintiff brought a class action challenging the validity of federal guidelines for parole release and was released from prison during his class action. 445 U.S. at 393-94. The Supreme Court held that the plaintiff had standing to litigate class certification in a suit seeking prospective relief because his claim was “so inherently transitory that [a] trial court w[ould] not have even enough time to rule on a motion for class certification before [his] individual interest expire[d].” Id. at 399, 403.
In Gerstein, the Supreme Court permitted a class of prisoners seeking preliminary probable-cause hearings to continue requesting prospective relief, even though the named plaintiffs’ individual claims had expired since their initial filing. 420 U.S. at 110 n.11 (“Pretrial detention is by nature temporary, and it is most unlikely that any given individual could have his constitutional claim decided . . . before he is either released or convicted.”). In Sosna, the Supreme Court permitted a woman whose individual claim had expired to continue seeking
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prospective relief on behalf of a class challenging Iowa’s one-year residency requirement for divorce. 419 U.S. at 399–401.
Relying on these cases, the Third Circuit and district courts within the Circuit have consistently held that plaintiffs with expired individual claims retain standing to pursue prospective relief under the “inherently transitory” exception. In Richardson v. Bledsoe, the Court ruled that a prisoner challenging a policy alleged to violate the Eighth Amendment (by not protecting inmates from attacks by others), but whose individual claims had been mooted by his transfer to another prison, had continued standing even though his motion for class certification was not filed until after his transfer. 829 F.3d 273, 276 (3d Cir. 2016). The Court determined that the claim was inherently transitory and that under the relation back doctrine, where the initial complaint was styled as a putative class action, standing was preserved and no formal motion for class certification was necessary. Id. at 286. As the Court explained, to require that a class certification motion be filed before the change of circumstances would create an unseemly race in which the plaintiff would seek class certification before defendants took steps to moot the claim by actions that would remove personal standing. Id. at 283. Here, of course, plaintiffs are in an even stronger position as they filed the initial class action motion well before their personal claims became moot.
Where a class motion is filed but, as here, by agreement among the parties and the Court, the motion is either held in abeyance or withdrawn without prejudice to allow discovery on the class issues, and then re-filed in a timely manner under the Court’s Scheduling Order, standing is preserved. In Gayle, 838 F.3d 297, plaintiffs filed three motions for class certification, the first while they had individual standing, but the second and third after their personal claims for injunctive relief became moot. The Court ruled that since the first two motions were not
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resolved on the merits, and the first motion was denied solely to allow completion of discovery, the later motions were functionally a continuation of the original motion for class certification and, therefore, “there was no denial of class certification based on a Rule 23 analysis or other intervening event that could be deemed to break the jurisdictional chain.” Id. at 307. Gayle directly controls disposition of this issue in this case. See also Wilson v. Gordon, 822 F.3d 934, 942-43 (6th Cir. 2016) (withdrawal of motion for class certification to allow for processing of plaintiffs’ administrative claims for certain benefits was not a voluntary relinquishment of their federal court claims and did not moot the class claims).
Courts in this district have also applied these principles. In Bowers v. City of Philadelphia, Judge Surrick ruled that pre-trial detainees alleging prison overcrowding were permitted to seek prospective relief on behalf of a class even though they were released from prison before class certification. No. 06-CV-3229, 2006 WL 2818501, at *7 (E.D. Pa. Sept. 28, 2006). As the Bowers court observed, while the plaintiffs were “no longer pre-trial detainees enduring the conditions alleged in the[ir] [c]omplaint, the duration of pre-trial custody d[id] not last much more than a week.” Id. Hence, it would be “impossible . . . to rule on class certification before any of the named [p]laintiffs’ personal stakes in injunctive relief expire[d].” Id. Were the court to “deny class certification or dismiss the case for lack of standing by the named [p]laintiffs, the alleged harm would never receive judicial review.” Id. Because the plaintiffs alleged constitutional violations and “given that it [wa]s certain that other pre-trial detainees” were being detained—and would “in the future be detained”—under the allegedly unconstitutional conditions, their case was inherently transitory. Id. Accordingly, the plaintiffs had “standing to bring th[eir] class action for injunctive and declaratory relief.” Id.
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Similarly, in Sourovelis v. City of Philadelphia, 103 F. Supp. 3d 694, 702-704 (E.D. Pa.
2015), Judge Robreno ruled that since it was unlikely that an individual plaintiff could be subject
to a forfeiture action for the entire duration of plaintiffs’ class action (the plaintiffs were in the
system under challenge for seven months and ten months respectively), the filing of the motion
for class certification was sufficient to preserve the named plaintiffs’ standing to seek class
certification. See also Williams v. City of Phila., 270 F.R.D. 208, 220 (E.D. Pa. 2010)
(permitting named plaintiffs challenging prison conditions to continue seeking prospective relief
on behalf of a class after their pre-certification release from custody; if plaintiffs with pending
class-certification motions were not allowed to continue litigating their claims, it would create a
“black hole . . . to constantly add new named plaintiffs or file new class-action complaints when
previously named plaintiffs’ claims are resolved.”)
Accordingly, there is no basis for dismissal on standing or mootness grounds.
B. The DOC Policies and Practices Violate The Eighth Amendment Rights of the Inmate Class to be Free from Deliberate Indifference to the Need for Medical Treatment Where Available Treatment Would Provide a Full Medical Cure for the Serious Medical Condition of the Class Members 1. The Governing Eighth Amendment Standards
In the recent ruling on the defendants’ motion to dismiss the First Amended Class
Action Complaint, this Court set forth the standards to be applied in an Eighth Amendment
challenge to the denial of medical treatment for prisoners:
“Deliberate indifference can be shown by a prison official ‘intentionally denying or delaying access to medical care or intentionally interfering with the treatment once prescribed.’” Rhines v. Bledsoe, 388 F. App’x 225, 227 (3d Cir. 2010) (quoting Estelle, 429 U.S. at 104-05). “A medical need is serious if it ‘has been diagnosed by a physician as requiring treatment or one that is so obvious that a lay person would easily recognize the necessity for a doctor’s attention.’” Id. (quoting Monmouth Cnty. Corr. Inst. Inmates v. Lanzaro, 834 F.2d 326, 347 (3d Cir. 1987)). Moreover, “to be considered ‘serious,’” the medical need must be such that “a
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failure to treat can be expected to lead to substantial and unnecessary suffering, injury, or death.’” Tsakonas v. Cicchi, 308 F. App’x 628, 632 (3d Cir. 2009) (quoting Colburn v. Upper Darby Twp., 946 F.2d 1017, 2023 (3d Cir. 1991)). A prison official acts with deliberate indifference to a serious medical need “when he knows of and disregards an excessive risk to inmate health or safety.” Brown v. Thomas, 172 F. App’x 446, 450 (3d Cir. 2006) (citing Farmer, 511 U.S. at 837). “The official must be aware of the facts from which an inference would be drawn that a substantial risk of serious harm exists, and he must also draw the inference.” Id. (citing Farmer, 511 U.S. at 837). Chimenti v. Pa. Dep’t of Corr., Civil Action No. 15-3333, 2017 U.S. Dist. LEXIS 124892, at *17-18 (E.D. Pa. Aug. 8, 2017). Applying this standard, the Court ruled that the allegations of the First Amended Complaint sufficiently alleged the level of deliberate indifference necessary to state a federal constitutional claim. The Court specifically rejected the defendants’ arguments that (1) the DOC deviations from the community standard of care for Chronic Hepatitis C reflect only “mere disagreements” as to the treatment regimen and, therefore, are not actionable under the Eighth Amendment, and (2) where cost considerations are relevant to the decision to provide a certain type of treatment, there cannot be a finding of deliberate indifference. Id. at 14-21. 2. Defendants’ Arguments in Support of the Motion for Summary
Judgment Are Without Merit On summary judgment, defendants make the same arguments rejected by this Court on the motion to dismiss. These arguments fail again as plaintiffs have produced evidence, much of which is from deposition testimony of the defendants, other officials in the DOC, and the DOC medical expert, that fully supports the Eighth Amendment claims credited by this Court on the motion to dismiss. Further, to the extent, the defendants argue related or re-packaged
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grounds for summary judgment, there are seriously disputed issues of fact that preclude summary judgment.
a. Plaintiffs at F-3 and F-4 are Entitled to DAA Treatment and Their Claims are not Moot
Defendants assert that the Protocol and related DOC practices with respect to DAA treatment do not show deliberate indifference to inmates with Chronic Hepatitis C on the ground that the most serious conditions (F-3 and F-4) have been and will continue to be treated, that those at F-2 will be treated in 2018, and that there is no need to treat those at F-0 and F-1. These arguments are all without merit.
As to inmates at F-3 and F-4, defendants essentially concede that they are constitutionally entitled to DAA treatment. The testimony of Dr. Cowan, Dr. Noel and Dr. Kendig, the three DOC medical witnesses (including their own expert witness), detail the serious nature of Hepatitis C at F-3 and F-4, including high risks of liver cancer, liver failure, and death. None of these witnesses assert that costs or any other non-medical factors would justify withholding DAA treatment for these patients. See Kendig Dep. Ex. K, 72 (“I would argue that treating F-3 and F-4 is medically necessary.”); id. at 85 (“patients are entitled to be treated even if . . . [they are] not [at] substantial risk of death”); Cowan Dep. Ex. D, 60 (in treating F-3 and F-4, DOC is treating the “sickest” of the Hepatitis C patients); id. at 62 (he knows of no study that contradicts any of the recommendations for treatment in AASLD Guidance); Noel Dep. Ex. H, 38-40, 145 (stating fatigue, cardiovascular disease, diabetes, renal disease, and B-cell lymphoma, as associated with Hepatitis C); id. at 143-44 (stating that risk of liver cancer remains for people at F-3 and F-4 even after DAAD treatment); see also Trooskin Dep., Ex. J, 47-48.
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The current treatment of this cohort of patients does not moot the request for an injunction. To the contrary, a defendant’s voluntary cessation of a challenged practice does not deprive a federal court of its power to determine the legality of the practice and to issue injunctive relief. Knox v. Serv. Emps. Int’l Union, Local 1000, 567 U.S. 298, 307-08 (2012); City of Mesquite v. Aladdin’s Castle, Inc., 455 U.S. 283, 289 (1982). The defendant “bears the formidable burden of showing that it is absolutely clear the allegedly wrongful behavior could not reasonably be expected to recur.” Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 190 (2000) (emphasis added); see also City of Mesquite, 455 U.S. at 289 n.10 (“A case might become moot if subsequent events made it absolutely clear that the allegedly wrongful behavior could not reasonably be expected to recur.”) (citation omitted); Sourovelis, 103 F. Supp. 3d at 701 (“Plaintiffs correctly contend, however, that these purported changes to Defendants' procedures—enacted only after litigation ensued—do not moot said claims.”); Cobb v. Aytch, 472 F. Supp. 908, 919–20 (E.D. Pa. 1979), aff'd in part, remanded in part, 643 F.2d 946 (3d Cir. 1981) (“The changes in the transfer policies . . . are not embodied in state regulations and defendants are free to alter them,” and, thus, “the controversy cannot be deemed moot.”).
The Supreme Court has further held that even a legislative repeal of an unconstitutional law or practice is insufficient to show that the behavior could not reasonably be expected to recur. See Ne. Fla. Chapter of Associated Gen. Contractors of Am. v. City of Jacksonville, Fla., 508 U.S. 656, 662 (1993) (holding city’s repeal of challenged ordinance and replacement with new ordinance that slightly changed old one did not moot challenge to case); City of Mesquite, 455 U.S. at 289 (“[T]he city’s repeal of the objectionable language would not preclude it from reenacting the precisely same provision[.]”); see also People Against Police Violence v. City of
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Pittsburgh, 520 F.3d 226, 231 n.2 (3d Cir. 2008) (“[N]either the City’s initial representation that it would no longer enforce [the challenged ordinance] nor its formal repeal of that ordinance a few months later deprived the District Court of jurisdiction, particularly given that plaintiffs’ complaint alleged a long history of unconstitutional conduct under the ordinance[.]”); Bowers v. City of Phila., No. 06-CV-3229, 2007 WL 219651, at *32 (E.D. Pa. Jan. 25, 2007) (“It is the duty of the courts to beware of efforts to defeat injunctive relief by protestations of repentance and reform, especially when abandonment seems timed to anticipate suit[.]”) (quoting United States v. W.T. Grant Co., 345 U.S. 629, 632 n.5 (1953)).
If the legislative repeal of an unconstitutional practice is insufficient to moot a challenge to that practice, an administrative protocol that has no force of law and can be changed, amended or terminated at any time, cannot bar a claim for injunctive relief. The record of this case shows that the DOC policies regarding treatment of inmates with Chronic Hepatitis C are highly malleable, subject to change depending on circumstances and conditions unrelated to medical standards and needs, and provide only general guidance under a vague prioritization standard. When the Complaint in this case was first filed, there was no protocol and no treatment of any inmate with Hepatitis C with DAA. Thereafter, in 2015 (notably after the complaint in this action had been filed), an Interim Protocol was adopted which did not mandate DAA treatment for any inmate and provided only general guidelines for “prioritization” of those with this condition. In November 2016, the current Protocol was adopted, and continued the use of only generalized guidelines for treatment.
The record makes clear that “prioritization” is a code-word for the rationing of DAAs without regard to medical necessity. In discussions leading up to the adoption of the protocol, Dr. Scharff, then the DOC Chief of Clinical Services, Bureau of Health Care Services, and
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Eugene Ginchereau, Assistant State Medical Director, provided Dr. Noel with suggested guidelines as to which patients should be provided DAA treatment. These guidelines advised that inmates with an APRI score at or greater than 1.0 should be treated. Noel Dep. Ex. H, 8182. But Dr. Noel rejected that standard—not because the medical condition did not warrant DAA treatment—but because it created too large a number of inmates to be treated. Id. This point was repeated in a February 18, 2015 email from Dr. Noel stating that use of elastography science would create “a bucket of potential patients which is too large to treat.” Ex. L. Left unsaid was the fact that elastography is the “gold standard” for determining fibrosis levels. See Cowan Dep. Ex. D, 42-43. Dr. Noel’s refusal to provide treatment based on this test is but another example of non-medical factors driving treatment decisions. In any event, the protocol does not require DAA treatment for any specific individual or even for classes of inmates and the current practice of treating those at F-3 and F-4 could be changed at any time and for any reason. See Trooskin Dep. Ex. A, 8-9.
b. Plaintiffs at F-0 to F-2 are Entitled to DAA Treatment The DOC assertion that those at F-2 will be treated in 2018, whether or not based on the recognition that patients at that stage are in need of the DAA treatment for a serious medical condition, cannot moot the claim for injunctive relief. The DOC’s statement of intent to treat those at F-2 in 2018, communicated by counsel for DOC is aspirational only, is not part of any binding budget plan, is not legally enforceable, and is subject to change at any time and for any reason. Moreover, defendants make no argument that they are not entitled to such treatment under the Eighth Amendment. The defendants’ argument that inmates at F-0 and F-1 have no medical need for DAA treatment fails to account for their existing medical symptoms and the risk that non-treatment
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will lead to more severe and life threatening conditions. The denial of DAA treatment to all
inmates at F-1 and F-0 is defensible only if there is no dispute as to whether these Chronic
Hepatitis C inmates are suffering from a serious medical condition.8 Plaintiffs have set forth
abundant evidence that demonstrates the need for treatment with DAAs for all persons with
Chronic Hepatitis C. As discussed above, every major medical association and organization that
is concerned with Hepatitis C treatment urges universal treatment, and they do so in recognition
of both the need to alleviate painful and debilitating symptoms and to prevent even more serious
consequences as these patients move to higher fibrosis levels. Dr. Noel and Dr. Trooskin agreed
that the AASLD Guidance was one of universal treatment with DAAs, except for medical
contraindicators. See Noel Dep., Ex. H, 77; Trooskin Dep., Ex. J, 21.
As plaintiffs’ expert Dr. Trooskin has testified and has documented in her expert report,
significant numbers of patients at F-0 to F-2 are suffering from serious medical symptoms, both
hepatic and extra-hepatic.9 These symptoms include fatigue, sore muscles, joint pain, kidney
injury, rashes, and depression. As Dr. Trooskin states:
Individuals who meet the standards set forth by the AASLD and IDSA, but who are excluded from receiving care, are put at significant risk of many medical complications of HCV. HCV is known to have extrahepatic manifestations, described as effects on organ systems outside the liver. Without treatment, individuals
8 It is important to note that even if the defendants were correct on this issue—that those at F-0 and F-1 are not suffering a serious medical condition—the DOC would still have the burden to show that it uses tests and measures that reliably reflect the F stage of every inmate with chronic Hepatitis C. But as the defendants concede, infra, the tests currently in use in the DOC are highly imperfect and mis-identify hundreds of inmates who are actually at F-2 – F-4 as F-0 or F1. 9 As examples of individuals with extra-hepatic conditions resulting from Chronic Hepatitis C, Daniel Leyva complains of pain and aches throughout his body, and according to the DOC records, he has an APRI score of 0.179 but has not had an elastography exam so his F score is unknown. See Leyva grievances, Ex. V. Salvatore Chimenti has stage 4 cirrhosis and now suffers from extreme fatigue, memory loss, and has developed diabetes due to Hepatitis C. See Dr. Cecil Rep., Ex. Q.
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may be needlessly exposed to depression, fatigue, sore muscles, joint pain, kidney injury, diabetes or glucose intolerance, certain types of rashes or autoimmune diseases. Without treatment, individuals with HCV are at increased risk of developing cirrhosis, liver cancer and liver failure requiring transplant. Furthermore, once individuals develop advanced liver disease they must undergo cancer screening at regular intervals for the rest of their life even after they are cured of their HCV.
Trooskin Rep., Ex. A, 5; See also Trooskin Dep., Ex. J, 47-48.
Moreover, Dr. Trooskin and other experts have documented that for those at F-0 and F-
1, delay in treatment is dangerous:
Mere observation and “monitoring” of HCV patients, with no medical treatment is medically inappropriate, falls below the standard of care, and risks the health of the individual with HCV. Delaying treatment has a variety of adverse effects including increasing the risk of death, causing irreversible liver damage, and needlessly prolonging suffering associated with the disease. From a public health perspective, observation without treatment risks spreading the disease to others. It is critical that patients with chronic HCV be treated before the liver has been damaged by the virus. Delaying treatment while that individual’s liver degrades significantly increases the risk of death from cancer, liver failure and a liver transplant. Once a person reaches a fibrosis score of F3 her chance of getting liver cancer is so significant that it is recommended that, even after having been cured with a DAA, the individual undergo twice yearly liver imaging surveillance for liver cancer.
Delay in treatment can cause damage to other vital organs. It is a systematic disease that, if untreated, can cause heart attacks, fatigue, joint pain, depression, sore muscles, arthritis, and, at times, premature death. Gill, Ghazinian, Manch Gish, Hepatitis C virus as a systemic disease; reaching beyond the liver, HEPATOLOGY INTERNATIONAL, Vol. 9, No. 4 (2015). I strongly agree with the current HCV Guidance which provide that “[b]ecause of the many benefits associated with successful HCV treatment, clinicians should treat HCV-infected patients with antiviral therapy with the goal of achieving an SVR, preferably early in the course of their chronic HCV infection before the development of severe liver disease and other complications.”
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Id. at 6. 10 The defendants and their witnesses concede a number of these points. Thus, both Dr.
Noel and Dr. Cowan testified that they had no basis to disagree with any of the reasons provided by the AASLD in its official Guidance for the need for universal treatment, including the presence of symptoms at early stages; the increased effectiveness of DAA treatment at the earliest possible point of intervention in the disease cycle; and preventing otherwise significant suffering, preventable cancer, liver failure, and death. See Noel Dep., Ex. H, 46-50; Cowan Dep., Ex. D, 62-63. Further, Dr. Noel, Dr. Cowan and Dr. Kendig have all acknowledged the point made by Dr. Trooskin that patients at F-0 to F-2 can and do suffer from a range of symptoms caused by Chronic Hepatitis C. See, e.g., Kendig Dep., Ex. K, 38-40; 117-119 (significant number of patients at F-0 may have extra –hepatic symptoms); Cowan Dep., Ex. D, 49; 51-53; Noel Dep., Ex. H, 53-59; 125; 142 (severe fatigue can be present at F-1-2).
To the extent that Dr. Noel and Dr. Kendig take issue with the AASLD Guidance and the national community standard of universal treatment, they do so on the basis of plainly erroneous understandings of the standard of care for prisoners under the Eighth Amendment. Dr. Kendig asserted that, under the Protocol, treatment for prisoners is provided for those with a current “life threatening liver condition,” Kendig Report, Ex. B, 5, and for those with “severe illness” or facing “death.” Id. Dr. Cowan referenced treatment for those with “irreversible damage” or “imminent risk of death.” Noel Dep., Ex. H, 96. Dr. Noel testified consistently
10 Defendants also argue that patients are not harmed due to the slow progression of the disease, but some patients progress and develop fibrosis at a fast rate, and that there is no way to determine who will progress more quickly. See Trooskin Dep. 38:7-22. Dr. Cowan also admitted that you rarely know what “time zero” is, i.e. when the person first became infected and thus when the clock starts. See Cowan Dep. 124:4-5. Dr. Trooskin gave an example of a patient she treated in her early 20s, who likely had only been infected for four to five years but had already advanced to F-3 in that short time frame. See Trooskin Dep., Ex. J, 79.
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with a belief that treatment is necessary only to prevent “irreparable harm.” Noel Dep., Ex. H, 79; 94.
In an attempt to explain his view, Dr. Kendig, without any documentary proof, testified that inmates would receive treatment before the onset of harmful consequences, but he could not point to a single case file that showed treatment before the inmate was at F-3 or F-4. Id. 89-91. And, in discovery, notwithstanding requests for such documentation, the DOC has failed to provide any such evidence. See Ex. M. Dr. Kendig agreed that research studies showed that 4.7% of patients at F-2, and 2.3% of patients at F-0 and F-1 would advance to liver failure and/or liver cancer without treatment and that applying that analysis to the DOC Hepatitis C patient list, approximately 420 patients would be in the very high risk category. Kendig Dep., Ex. K, 91-96. Moreover, an implication of Dr. Kendig’s Report is that thousands of inmates who are not treated with DAAs will suffer “harmful health consequences.” Id.at 89.
The constitutional standards offered by Dr. Kendig, Dr. Noel, and Dr. Cowan are wide of the Eighth Amendment mark. As we set forth above, and as this Court has already ruled, one need not be near death, already have suffered irreversible damage, or have a life-threatening condition to be entitled to treatment. To the contrary, the standard is one of a “serious medical condition,” which includes many conditions that do not pose a risk of imminent death, and which would include the “harmful health consequences” referenced by Dr. Kendig. Treatment is necessary for any conditions that cause significant pain, disability, injury, or illness, far before there is the irreversible damage. See Spruill v. Gillis, 372 F.3d 218, 235 (3d Cir. 2004); Monmouth Cy. Corr. Inst. Inmates v. Lanzaro, 834 F.2d 326, 346-47 (3d Cir. 1987). The Supreme Court and the Third Circuit have consistently ruled that one who is exposed to conditions that could eventually lead to serious illness or death, even without any current
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symptoms, is entitled to judicial relief. See, e.g., Helling v. McKinney, 509 U.S. 25, 33-34 (1993) (exposure to dangerous levels of second-hand smoke; “It would be odd to deny an injunction to inmates who plainly proved [a] life-threatening condition . . . on the ground that nothing yet had happened to them.”); Atkinson v. Taylor, 316 F.3d 257, 264-66 (3d Cir. 2003) (same). See also Farmer v. Brennan, 511 U.S. 825, 837 (1994); Postawko v. Mo. Dep’t of Corrections, 2017 WL 1968317, *7 (W.D. Mo. May 11, 2017) (Hepatitis C infected inmates “not required to suffer ‘imminent, life threatening circumstances’ in order to allege deliberate indifference). In sum, with respect to inmates at F-2, 3 and 4, an injunction is necessary to ensure that promised DAA treatment will in fact be provided. Further, on the question of whether DAA treatment is necessary for those at F-O and F-1, disputed issues of material fact preclude summary judgment.
c. Defendants’ Reliance on APRI Scores to Determine DAA Treatment is Evidence of Deliberate Indifference to the Need for Medical Treatment
Moreover, even if the defendants were correct in their assessment of the seriousness of the Hepatitis C infection based on F scores, treatment decisions could only be valid if the tests used to measure the F score are valid and accurate. But, as every expert in this case has testified, that is quite definitively not the case in the DOC. The DOC makes a determination of the F-score primarily from an “APRI score,” which is based on blood tests that provide a ratio derived from the level of an enzyme “AST” in the blood and blood platelet levels.
APRI scores are reflective of F scores along the following approximate scale: APRI 00.5=F-0; APRI 0.5-1=F-1; APRI 1-1.5=F-2; APRI 1.5-2=F-3; APRI 2 or more=F-4. See D. Appx. N, Noel Decl. at 4. All of the medical witnesses in this case have stated that the APRI score is accurate only at the extremes of the F scale and the score is highly imprecise in the critical middle ranges. As Dr. Cowan testified, an APRI score of 1.5 fails to reveal cirrhosis (F-
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4) in 35% of the cases and an APRI score as low as 1.0 fails to reveal cirrhosis in 23% of the cases. See Cowan Dep., Ex. D, 42-47. Dr. Kendig referenced a study that showed that 48% of patients with APRI scores at or above 1.0 were at a significantly higher F score. Kendig Dep., Ex. K, 55-56. Thus, in a DOC population of approximately 5500 inmates with Chronic Hepatitis C, there will be hundreds of inmates with APRI scores that fail to measure the true severity of their disease.11 Moreover, in the data provided by the DOC 179 patients were listed without any APRI score. Kendig Dep., Ex. K, 71. Dr. Kendig stated that any privatization protocol requires accurate F-scores, id. 65, but that under the DOC testing process, which does not include the most advanced and accurate tests, patients with conditions that he views as sufficiently serious to require DAA treatment will be missed. Id. at 69.12
The DOC does not routinely use more precise tests, including FibroScan, a type of ultrasound known as “transient elastography,” that all experts credit as the most reliable indicator of fibrosis levels. See Trooskin Rep., Ex. J, 8; Kendig Dep., Ex. K, 61-62; 66-67. Defendants rely almost exclusively on a test that is highly flawed. Accordingly, even under the defendants’ position as to what F-score requires DAA statement, hundreds of inmates in that category are being denied necessary DAA treatment. See Postawko v. Mo. Dep’t of Corrections, 2017 WL 1968317, at *6-7(noting highly imprecise nature of APRI scores).
11 As one example, inmate C.S. (No. XX-XX58) had stage 4 cirrhosis (F-4), yet according to the DOC tracking spreadsheet, had an APRI score of under 0.5 (actual APRI recorded was 0.414). See Inmate C.S. medical records, Ex. W. 12 In Exhibit F to Defendants’ Motion for Summary Judgment, Richard Wenhold provides data as of September, 2017 as to the breakdown by APRI scores for inmates with Chronic Hepatitis C. The current data would not in any material way affect that earlier testimony and analysis.
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d. The Relevance of Community Medical Standards This Court has rejected the DOC’s argument that inmates are not entitled to medical treatment under generally accepted and established community medical standards of care. In this case, there is no dispute as to the community standard of care for persons with Chronic Hepatitis C: treatment with DAAs. Every national health organization that deals with this condition advocates universal treatment of all such patients (subject only to special and limited exceptions for persons with a very short life expectancy or other medical conditions which contra-indicate DAA treatment). DAAs provide a full cure with no or very infrequent side effects and prevent the disease from progressing to a point where there is suffering from physical and emotional symptoms as well as to serious risks of cancer, liver failure, and death. The AASLD, the Veterans Administration, the Center for Disease Control, and Medicare promote and/or provide universal treatment; and in Pennsylvania, Medicaid will be providing DAA to all Chronic Hepatitis C patients as of January 2018.13 Courts have looked to established community care standards in Eighth Amendment analysis: indeed, for chronic and or infectious conditions like HIV, Hepatitis C, diabetes, and high blood pressure, it is difficult to understand how established community medical protocols would not be generally applicable in the prison medical setting. Further, the DOC has repeatedly stated that medical care, and in particular medical care for inmates with Hepatitis C,
13 The DOC argument that the VA does not have a policy of universal treatment is incorrect. See Cowan Dep., Ex. D, 24 (VA and CDC recommend universal treatment); see also Department of Veterans Affairs New Release, “VA Expands Hepatitis C Drug Treatment, dated March 9, 2016, available at https://www.va.gov/opa/pressrel/pressrelease.cfm?id=2762; (“The Department of Veterans Affairs (VA) today announced that it is now able to fund care for all Veterans with hepatitis C for Fiscal Year 2016 regardless of the stage of the patient’s liver disease”); VA Fact Sheet, dated September 2017, available at https://www.hepatitis.va.gov/pdf/VA-HCV-FactSheet.pdf (“All Veterans with hepatitis C in VA care are eligible for treatment.”).
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is provided on the basis of community care standards. In responding to grievances filed by each of the named plaintiffs, the DOC explicitly stated that their care was governed by “community standards of care” for this disease. See Cowan Dep., Ex. D, 19-21; see also Letter to Leyva, Ex. E; Letter to Maldonado, Ex. F. Further, the contracts between the DOC and its medical provider specify community standards of care. See Noel Dep., Ex. H, 13-16; 19-20.
The DOC seeks to avoid community standards by characterizing this case as a simple a matter of “disagreement” among experts, and arguing that a prisoner is not entitled to treatment of his choice, even if offered in the community. D. Mem. at 18. But as this Court stated in its ruling on the motion to dismiss, the allegations (and now the proof) in this case do not permit such an argument: if Chronic Hepatitis C is a serious medical condition, there is only one course of effective treatment, that which provides DAAs. See Chimenti, 2017 U.S. Dist. LEXIS 124892, at *18-32. Deliberate indifference can be established even where some “treatment” or medical oversight is provided, particularly where, as here, what is offered as treatment falls well short of established community medical practice standards. See, e.g., Keller v. Cty. of Bucks, 209 F. App’x 201, 204-05 (3d Cir. 2006) (affirming verdict of Eighth Amendment violation for failing to properly treat MRSA infections even though plaintiff was seen by medical staff and was provided with antibiotics); White v. Napoleon, 897 F.2d 103, 109 (3d Cir. 1990) (explaining that a doctor who “insisted on continuing courses of treatment that the doctor knew were painful, ineffective or entailed substantial risk of serious harm to the prisoners” rises to the level of deliberate indifference); Inmates of Allegheny Cty. Jail v. Pierce, 612 F. 2d 754, 762 (3d Cir. 1979) (a choice between treatments must be informed by “sound professional judgment”); Petties v. Carter, 836 F.3d 722, 729-30 (7th Cir. 2016) (en banc) (distinguishing between a “difference of opinion” regarding treatment and cases where the standard of care requires a
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specific mode of treatment; choice by prison of “easier and less efficacious treatment” not
sufficient if not in accord with sound medical judgment); McDonald v. Hardy, 821 F.3d 882, 891
(7th Cir. 2016) (treating high cholesterol condition by medications only and not providing a
proper diet violated Eighth Amendment, where diet is integral part of treatment of high
cholesterol; “disagreement” over treatment is not a defense to claim); Roe v. Elyea, 631 F.3d
843, 857-858 (7th Cir. 2011) (“[A] successful plaintiff need not show that he was literally
ignored in his demands for medical treatment, and a defendant's showing that a plaintiff received
some treatment does not resolve the issue conclusively if the treatment was blatantly
inappropriate.”) (internal quotations omitted); Postawko v. Mo. Dep’t of Corrections, 2017 WL
1968317, at *9 (W.D. Mo. May 11, 2017) (failure to provide DAA treatment for Hepatitis C
inmates is denial of any treatment and not a mere dispute as to proper course of treatment).
As this Court stated in the Opinion on the motion to dismiss, the DOC Protocol has
already been found to be constitutionally deficient, citing Abu-Jamal v. Wetzel, 3:16-CV-2000,
2017 WL 34700, at *11 (M.D. Pa. Jan. 3, 2017) (Hepatitis C Protocol results in a “conscious
disregard of a known risk that inmates . . . will suffer from Hepatitis C related complications”).
Dr. Trooskin’s expert report provides a strong evidentiary basis for this conclusion:
The Chronic Care Clinic policies (Sections G, H, and I) reflect the current DOC rationing and prioritization process. In my opinion, there are serious medical flaws in both the diagnostic and treatment regimens. First, as explained above, there is no medical justification for prioritization. Second, even if priorities were acceptable, F-score is based primarily on the APRI calculation and very few inmates are provided a FibroScan. Thus, the initial determination of the fibrosis-score is highly unreliable.
Third, even where all diagnoses point to cirrhosis or advanced fibrosis, there is no provision that mandates DAA treatment; rather, other evaluations are required (see Section H which recognizes the benefit of universal treatment, but then prioritizes DAA treatment according to APRI scores and some elastography
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testing). Approximately 5% of all inmates with HCV have been provided with DAA treatment under the Protocol. For almost all inmates with HCV, there is no treatment. Thus, there are thousands of patients with a serious medical condition that will worsen over time and who have already manifested symptoms, who are denied a medical treatment that would fully cure them of this illness. Indeed, the complicated and costly, but ultimately reliable diagnostic and treatment standards in sections G and H would be entirely unnecessary with universal treatment.
Trooskin Rep., Ex. A, 9.
Defendants’ argument that financial costs are a permissible factor in determining the
type of treatment to be offered, see D. Mem. at 19-20, repeats the argument made on the motion
to dismiss where this Court ruled that allegations that DAA treatment is rationed “based solely
on cost, even though there is no other recommended medical treatment for Chronic Hepatitis C,
disregards an excessive risk to the health of infected inmates and thus constitutes deliberate
indifference to a serious medical need.” Chimenti, 2017 U.S. Dist. LEXIS 124892 at *22-23,
citing Allah v. Thomas, 679 F. App’x 216, 220 (3d Cir. 2017).
On summary judgment, there is substantial evidence that costs are not a defense to the
denial of DAA treatment. First, the defendants have presented evidence that strongly
contradicts their argument that financial costs are the reason for the refusal to treat all Chronic
Hepatitis C inmates with DAAs. For example, Christopher Oppman, the Deputy Secretary for
Administration at the DOC who is in charge of financial and other major administrative matters
involving delivery of health services to inmates, testified that the Hepatitis C treatment budget is
not based on financial costs, but rather on administrative factors such as the number of inmates
who could be treated on a yearly basis:
Q. So let me ask you this. We’ve been told in other depositions that the population of the DOC with chronic Hepatitis C is approximately 6500 or so and that currently some - according to Dr. Cowan this morning currently about 200
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inmates are being treated with DAAs. I think that Dr. Noel said it was a little bit higher than that but regardless of that number of 200 or 300, whatever it might be, if the medical people had said we ought to be treating 2000, not 200, would the DOC then provide the money for all those 2000 based on your answer here?
A. I would – I would say yes, if they come to us and say this is the patient caseload we need to treat, logistically we are able to do this and it’s not beyond the capabilities, that the DOC would request funding from the Governor’s office and from the Senate and House to try to obtain that funding to treat. Whatever is medically necessary we would attempt to do.
Q. So in your view, the cost is not the factor. The limiting factor is the number of treatments that are to [sic] or can be treated in the fiscal year?
A. Yes.
Q. And that refers to the issues you talked about, security, transportation, administration, and so on and so forth?
A. Correct sir.
Oppman Dep., Ex. N, 25-27 (emphasis added).14
Dr. Noel similarly asserted that administrative and security considerations were the
major barriers to universal treatment with DAAs. Noel Dep., Ex. H, 21-22. However, the
defendants have wisely not made any such argument in support of their motion for summary
judgment, as the record definitively rebuts this position. First, there is conclusive evidence that
“administrative” factors were never even considered in the two-year process leading to the
adoption of the current protocol. Defendants provided to plaintiffs all DOC emails over the
three-year period leading up to the adoption of the Hepatitis C Protocol and not a single one of
14 See also Exhibit O, Oppman Responses to Interrogatories, No. 19 (DOC Hepatitis C budget “is not based on cost of DAAs, but on estimate of the number of inmates that are to [sic] or can be treated in the fiscal year”).
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these hundreds of emails references any administrative or security concern in the discussions of treatment protocols. See Cowan Dep., Ex. D, 23-41. And, in follow-up discovery, the DOC defendants were unable to provide even a single document that referenced any such concerns. Ex. M.
Second, given the screening and monitoring by the DOC of Chronic Hepatitis C inmates, the medical information that is relevant to the DAA prescription process is already recorded. Thus, the factors cited by Dr. Noel, Dr. Cowan, Dr. Kendig, and Mr. Oppman on the supposed administrative barriers (e.g., the need for medical examinations, transportation of inmates for medical reviews, assessments by hepatologists, a need for elastography testing) are either accounted for or are not applicable in a regime of universal treatment. All of the information relevant to the proper DAA and any possible contra-indicators to DAA treatment is part of the medical spreadsheet for every inmate and, therefore, especially at the F-0, F-1 and F-2 stages, the DAAs can be prescribed without further examinations or extensive work-up of patients, a fact that defendants have conceded. See, e.g., Cowan Dep., Ex. D, 23-42; 60-61 (conceding that administrative steps such as transfer of inmates for medical testing; further medical workups to determine which DAA was appropriate; elastography testing and other measures that were necessary before the DAA could be prescribed were not necessary in a system of universal treatment, given the data available to medical staff due to screening and monitoring of inmates with Chronic Hepatitis C); Kendig Dep., Ex. K, 125-131 (same; with special reference to inmates at F-1 and F-0 whose conditions would rarely need special medical attention with respect to possible contra-indications to DAA treatment).
Nor are there any administrative barriers once the DAA is prescribed. At that point, large numbers of inmates can easily be treated with once-daily medication, no different than the
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thousands of inmates in the DOC who are currently being treated with medication at their respective institutions on a daily basis. Dr. Trooskin testified that given the screening and monitoring that the DOC provides for this class of patients, universal treatment could be provided for the entire class within a 12-18 month period. See Trooskin Dep., Ex. J, 65.
Moreover, notwithstanding this Court’s observation in its Opinion on the motion to dismiss that there were no allegations or other information before it as to the cost of DAA treatment, Chimenti¸ 2017 U.S. Dist. LEXIS 124892, at*29 n.3, the defendants fail to provide the Court with any up-to-date or reliable data on costs, and the defendants’ Memorandum of Law is silent on this critical question. There are references to the reduction in costs for DAA treatment from approximately $100,000 per individual regimen when this case was filed, to less than $50,000 as of early 2017. See Exs. B, D. But the defendants fail to cite, much less discuss, the most recent relevant development on this issue: in August 2017, the FDA gave approval for the use of the drug Mavyret, produced by the company AbbVie, which for the now-reduced eight-week regimen is list-priced at $26,400 and which is likely to drive down the costs of DAAs even further given the competition among the pharmaceutical companies that manufacture DAAs. See supra, 6 n. 4. Defendants’ expert witness, Dr. Kendig, correctly described this development as a “game changer” in terms of access to DAA medication for inmates and for greatly expanding the number who could be treated by prison systems. See Kendig Dep., Ex. K, 138 (emphasis added).
The defendants have failed to provide any cost/benefit analysis in terms of financial costs and have not considered cost-saving factors in universal treatment, including (1) the end of a system of monitoring and yearly (or more frequent) examinations and tests for the more than 5,000 inmates with Chronic Hepatitis C who are currently not being treated with DAA, (2) the
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reduction in the incidence in the spread of Hepatitis C in the prison system, and (3) the reduction in treatment costs for hepatic and extra-hepatic conditions of the thousands of inmates currently infected but not provided DAA treatment. Dr. Kendig recognized the significance of this factor, stating that the assessment of the actual financial costs of prioritization (as opposed to universal treatment) involves “an extremely complicated calculation.” Kendig Dep., Ex. K, 137. Moreover, Dr. Kendig conceded that there “can be significant cost benefits to treatment.” Id. at 137-138. The DOC has failed to conduct any such assessment or calculation and, therefore, defendants cannot seek summary judgment without the basic facts necessary to engage in a proper Eighth Amendment analysis.
Each of the arguments made by the DOC regarding plaintiffs’ Eighth Amendment claim is legally and/or factually flawed. The record in this case fully supports plaintiffs’ federal constitutional claims.
C. Plaintiffs State a Claim for Injunctive Relief Under the Pennsylvania Constitution
In the face of two prior rulings of this Court that plaintiffs state a claim for relief in Count II of the Amended Complaint (see Chimenti v. Pa. Dep’t of Corr., Civil Action No. 15-3333, 2016 U.S. Dist. LEXIS 36682, *22 (E.D. Pa. March 21, 2016); Chimenti, 2017 U.S. Dist. LEXIS 124892, at*12-13), defendants argue that this claim is “barred by sovereign immunity.” D. Mem. at 21. The Third Circuit has expressly rejected this argument in Pocono Mountain Charter Sch. v. Pocono Mountain Sch. Dist., 442 F. App’x 681, 688 (3d Cir. 2011):
Although monetary relief is barred for claims under the Pennsylvania Constitution, equitable remedies are available. See Moeller v. Bradford County, 444 F. Supp. 2d 316, 320-21 (M.D. Pa. 2006) (“[I]t is well settled that individual plaintiffs may bring suit for injunctive relief under the Pennsylvania Constitution”); Jones [v. City of Phila., 890 A.2d 1188, 1216 (Pa. Commw. Ct. 2006)] (“[Other remedies, such as declaratory or injunctive relief . . . are . . . remedies under the Pennsylvania
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Constitution.”). On remand, the District Court must consider whether plaintiffs have stated a valid claim for injunctive relief under Article I, § 3 or Article I, § 26 of the Pennsylvania Constitution (Footnotes omitted). Accordingly, the motion for summary judgment on this ground should be denied. D. Plaintiff Chimenti’s Individual Claim For Damages Should Proceed. Defendants argue that Plaintiff Chimenti’s claim for individual damages should be dismissed because he is unable to sufficiently prove causation on his claim for negligence.15 D. Mem. At 22-23. Plaintiff Chimenti brings a medical malpractice claim (and Eighth Amendment claim) alleging that he sought the DAA treating starting at the end of 2013, through requests to his medical doctor and through the grievance process, but faced a substantial delay of almost two years before receiving the DAA treatment. See Chimenti Med. Rec. Ex. S, Progress notes dated 12/13/13; Progress notes dated 1/22/14; Chimenti grievance dated May 16, 2014, Ex. U. Defendants refused to provide this treatment, first, because they had no Hepatitis C treatment protocol in place, and then because he did not fit into the criteria of the interim protocol, which at that time required the presence of esophageal varices (among other things) even though Chimenti was at stage 4 cirrhosis at that time. See Chimenti Med. Rec. Ex. S, Progress Notes dated 5/27/14.; see also Progress Notes dated 9/30/14 (“I explained again however that treatments are officially on hold in PA DOC for Hep C.”); Chimenti Med. Rec. Ex. S, Consultation Record dated 6/27/14 and 6/2/14 (“[B]ecause the DOC policy on Hep C treatments has not yet been completed any recommendations by a hepatologist would be moot
15 The class seeks injunctive relief only. There is one claim for individual damages brought by Salvatore Chimenti under the Eighth Amendment and for medical malpractice (negligence). With respect to the DOC Defendants, both Wetzel and Noel are defendants for the Eighth Amendment claim, and only Noel is a Defendant under the medical malpractice claim. The Correct Care Solutions/Wexford Defendants did not file a motion for summary judgment.
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till policies in DOC is finalized. Therefore collegial denied consult [with hepatologist] at this time.”). Noel email re Chimenti dated 12/28/14, Ex. T.
The DOC was aware of his condition and that he was at stage 4 cirrhosis. See Interim Hepatitis C Protocol, Ex. P; Chimenti medical records, Ex. S; Chimenti grievances, Ex. U. During this time, Chimenti developed a mass in his liver. Chimenti Dep., Ex. R, 39. Dr. Kephart and Dr. Frommer (who are CCS employees and have not filed a motion for summary judgment) failed to refer him to a hepatologist, and Dr. Frommer insisted that Chimenti undergo a biopsy before authorizing further treatment, a procedure that three doctors on three separate occasions deemed too dangerous or difficult to be performed. See Chimenti Dep. Ex. R, 47; Chimenti Med. Rec. Ex. S, Progress Notes dated 10/20/15 (“liver biopsy is risky”).16
During this time period, Dr. Noel was responsible for the treatment protocol and the decision of the DOC to cease all treatment while there was no treatment protocol. He was consulted and involved in the decisionmaking not to provide DAA treatment to Chimenti, including through email communications with medical personnel, he had the final authority to determine whether a particular individual received DAA treatment, and medical records indicate that medical staff consulted him on DAA treatment for Chimenti. See Noel Dep., Ex. H at 173, 177, 187.17 Dr. Noel had a key role in the significant delay in Chimenti receiving the necessary treatment for his Hepatitis C.
16 See also UPMC Altoona Final Report by Dr. James, 1/14/15 (“Liver lesion which could be an hemangioma and is difficult to biopsy safely given this possibility.”); UPMC – Presbyterian Final Report by Dr. Borhani, dated 2/18/16 (The decision to cancel the ultrasound-guided biopsy was discussed with Dr. Rabinovitz.”); UPMC Altoona Final Report by Dr. Shivers, 3/23/16 (“Biopsy of the abnormality was canceled [sic].”) 17 See also Noel email re Chimenti dated 12/28/14, Ex. T; see also Chimenti Med. Rec., Progress Notes dated 9/30/14 (“I discussed [with] [Chimenti] my attempt to get him to see a hepatologist & previous email to Dr. Noel.”); Progress Notes dated 12/19/14 (“Received email from Dr. Noel
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Chimenti’s condition worsened due to the substantial delay in treatment, and he developed a liver mass as well as diabetes, neither of which he had prior to 2013. His physical condition also worsened, with increased cognitive problems, memory loss, and pain. Defendants argue that plaintiff Chimenti’s expert report is insufficient to establish that Defendants’ failure to follow the standard of care caused injury to Chimenti.18 Testimony by experts may be used to “assist the trier of fact to understand the evidence or to determine a fact in issue.” Fed. R. Evd. 702; see also Donlin v. Philips Lighting N. Am. Corp., 581 F.3d 73, 81 (3d Cir. 2009). The expert in a medical malpractice case should offer an opinion that the “conduct breached the standard of care . . . and increased the risk of harm to [plaintiff].”19 Carrozza v. Greenbaum, 866 A.2d 369, 380 (Pa. Super. 2004). Further, contrary to what defendants argue, a plaintiff is not required to prove that defendants were the “but for” cause of his injuries, but only needs to establish that the conduct increased the risk of harm, and that ultimately the issue of causation is left for the factfinder. Id.
In this case, plaintiff’s expert report by Dr. Cecil is sufficient to establish causation. Dr. Cecil wrote that his opinions were with a “reasonable degree of medical certainty,” he had been treating patients with Hepatitis C for more than 20 years, and that for the past 19 years, 95% of his practice has been treatment of Hepatitis C. See Dr. Cecil report, Ex. Q. Dr. Cecil explained in his report that the standard of care was that that Chimenti be provided DAA treatment (at that
explaining CCS policy for Hep C treatment being reviewed & to let Mr. Chimenti know he will have an answer to him shortly.”). 18 The DOC defendants do not present an argument that Chimenti’s medical care (or lack of) met the standards of care. 19 Defendant cites a string of cases holding to the previous standard on causation. (See D. Mem. 23). In 1981, the Pennsylvania Supreme Court adopted the relaxed ‘increased-risk-of-harm’ standard for medical malpractice cases. Carrozza, 866 A.2d at 380 (citing Jones v. Montefiore Hospital, 431 A.2d 920, 923 (Pa. 1981); Hamil v. Bashline, 392 A.2d 1280 (1978)).
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time Sovaldi, peginterferon, and ribavirin). See id. Further, Dr. Cecil stated that Chimenti should have been referred to a liver cancer specialist once the mass was found and not a general oncologist. In any event he should not have been denied care due to the lack of a liver biopsy, as that would cause great risk of harm. See id. Dr. Cecil opined that Chimenti had cirrhosis that was life-threatening, and that the lack of treatment did injure Chimenti and increased his risk of death, liver cancer, worsening of liver failure, and increased the need for a liver transplant. See id. Dr. Cecil also explained that the two year delay irreparably worsened Chimenti’s condition, and that Chimenti now has diabetes likely related to his Hepatitis C, along with severe fatigue, and memory problems related to hepatic encephalopathy. See id. On a motion for summary judgment, this is sufficient to establish causation.
The DOC Defendants have not presented any expert opinion that the delay did not cause the injuries to Chimenti. To the contrary, Dr. Noel stated with regard to DAA treatment and Mr. Chimenti’s symptoms, that “had the virus [had] been removed from his body, there’s a chance that those symptoms would have been alleviated.” Noel Dep., Ex. H, at 186. Dr. Kendig also stated in his deposition that “treating F-3 and F-4 is medically necessary” and that he advised to treat the F-3s and F-4s “as quickly as possible.” Kendig Dep., Ex. K, 72:2-20. Dr. Kendig further testified that the progression to “cirrhosis is high for F-3 to F-4,” and that the fibrosis score strongly predicts the risk of future life-threatening liver disease related to chronic Hepatitis C infection. Id. at 74:5-7; 84:3-10; see also id. at 38-40 (citing fatigue as an extrahepatic condition, and that there is an association of Hepatitis C with diabetes).
Chimenti has sufficiently presented evidence that the delay authorized by defendants caused further injury, and therefore summary judgment should be denied.
38

Case 2:15-cv-03333-JP Document 101 Filed 11/02/17 Page 41 of 43

V. CONCLUSION The Defendants’ Motion for Summary Judgment fails as to each and every argument and
the Motion should be denied.

Date: November 2, 2017

Respectfully Submitted,
/s/ David Rudovsky David Rudovsky, PA Attorney No. 15168 Kairys, Rudovsky, Messing, Feinberg & Lin LLP 718 Arch Street, Suite 501S Philadelphia, PA 19106 (215) 925-4400
/s/ Su Ming Yeh Su Ming Yeh, PA Attorney No. 95111 Angus R. Love, PA Attorney No. 22392 Pennsylvania Institutional Law Project 718 Arch Street, Suite 304S Philadelphia, PA 19106 (215) 925-2966
/s/ Stephen D. Brown Stephen D. Brown, PA Attorney No. 27829 Christine Levin, PA Attorney No. 27829 Rose Marie Wong, PA Attorney No. 320602 Dechert LLP Cira Centre 2929 Arch Street Philadelphia, PA 19104 (215) 994-2404

39

Case 2:15-cv-03333-JP Document 101 Filed 11/02/17 Page 42 of 43

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

SALVATORE CHIMENTI, DANIEL

:

LEYVA, DAVID MALDONADO, and all

:

others similarly situated,

:

:

Plaintiffs,

:

:

:

v.

:

:

:

PENNSYLVANIA DEPARTMENT OF

:

CORRECTIONS; JOHN WETZEL, Secretary, :

Pennsylvania Department of Corrections;

:

PAUL NOEL, Chief Medical Director,

:

Pennsylvania Department of Corrections;

:

RICH WENHOLD, Infection Control

:

Coordinator, Pennsylvania Department of

:

Corrections; CORRECT CARE SOLUTIONS; :

DR. JAY COWAN, Medical Director, Correct :

Care Solutions; DR. JOHN KEPHART, Medical :

Director (former), SCI Smithfield; DR. JAMES :

FROMMER, Medical Director, SCI Smithfield; :

WEXFORD HEALTH SOURCES, INC.

:

:

Defendants.

:

Civil Action No. 15-3333
Judge John R. Padova (Filed via ECF)

CERTIFICATE OF SERVICE
I, the undersigned, hereby certify that I have on this date caused a copy of the foregoing
Plaintiffs’ Response to Motion for Summary Judgment, and Memorandum in support thereof, to
be served via ECF upon the following counsel of record:
Vincent Mazeski Chief Counsel’s Office Pennsylvania Department of Corrections 1920 Technology Parkway Mechanicsburg, PA Counsel for DOC Defendants
-1-

Case 2:15-cv-03333-JP Document 101 Filed 11/02/17 Page 43 of 43
Samuel Foreman Caitlin Goodrich Noah Katz Weber Gallagher Simpson Stapleton Fires & Newby, LLP 2 Gateway Center Suite 1450 Pittsburgh, PA 15222 Counsel for CCS and Wexford Defendants
/s/ Su Ming Yeh, Su Ming Yeh, PA Attorney No. 95111 Pennsylvania Institutional Law Project 718 Arch Street, Suite 304S Philadelphia, PA 19106 (215) 925-2966 Date: November 2, 2017
-2-

Case 2:15-cv-03333-JP Document 101-1 Filed 11/02/17 Page 1 of 1

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

____________________________________

SALVATORE CHIMENTI, et al.,

:

:

CIVIL ACTION NO: 15 Civ. 3333

Plaintiffs,

:

:

v.

:

Judge John R. Padova

:

PENNSYLVANIA DEPARTMENT OF :

CORRECTIONS, et al.

:

(Filed via ECF)

:

Defendants.

:

ORDER

Now, on this

day of

, 2017, upon consideration of

Defendants’ Motion for Summary Judgment, the motion is hereby are DENIED.

BY THE COURT:

J.

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 1 of 30

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

____________________________________

SALVATORE CHIMENTI, et al.,

:

:

CIVIL ACTION NO: 15 Civ. 3333

Plaintiffs,

:

:

v.

:

Judge John R. Padova

:

PENNSYLVANIA DEPARTMENT OF :

CORRECTIONS, et al.

:

(Filed via ECF)

:

Defendants.

:

PLAINTIFFS’ RESPONSE TO DOC DEFENDANTS’ STATEMENT OF MATERIAL FACTS AND COUNTERSTATEMENT OF ADDITIONAL FACTS
Plaintiffs hereby submit the following response to DOC Defendants’ Statement of Material Facts and a Counterstatement of Additional Facts.1
1. Admitted. 2. Admitted. 3. Admitted in part, denied in part. It is admitted that advances in medical for the treatment of Hepatitis C exist, but it is denied that this is the sole basis for this civil action. 4. Admitted in part, denied in part. It is admitted that Plaintiffs allege that DOC Defendants refuse to provide necessary medical treatment for their Hepatitis C by denying them the latest FDA approved direct acting anti-viral drugs (DAADs), but while the denial of DAADs is the primary focus of the case, it is denied that this is the sole allegation in how Defendants refuse to provide necessary medical treatment for Hepatitis C.

1 DOC Defendants’ did not confer with Plaintiffs on the material facts to determine if there could be any stipulations on materials facts, as required by Judge Padova’s Policies and Procedures. This has led to the inclusion by Defendants of numerous contested facts.
1

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 2 of 30
5. Admitted in part. For further clarification, Plaintiffs request class certification for individuals incarcerated in a Pennsylvania Department Corrections facility “who have at least twelve (12) weeks or more remaining to serve on their sentences . . . .” See Docket No. 94-1 (P Mem. In Support of Renewed Motion for Class Cert.) at 8.
6. Admitted. 7. Admitted. 8. Admitted. 9. Admitted. 10. Admitted. 11. Admitted. 12. Admitted in part, denied in part.2 It is admitted that the DOC has an inmate grievance system policy, DC-ADM 804, that provides an administrative procedure where inmates can seek resolution of problems, and admits that inmates can request compensation and other legal relief, but to the extent that it may be implied, it is denied that compensation is regularly available as an actual form of relief. It is further denied that the grievance system through DC-ADM 804 is the sole method for inmates to seek resolution of issues or for fulfilling exhaustion requirements pursuant to the Prison Litigation Reform Act (PLRA). 13. Admitted in part, denied in part. It is admitted that this is the process provided by DC-ADM 804. It is denied that this is the sole method for inmates to seek resolution of issues or for filling exhaustion requirements pursuant to the Prison Litigation Reform Act (PLRA).
2 As set forth in Plaintiffs’ Memorandum of Law in Opposition to Motion for Summary Judgment, all allegations regarding failure to exhaust administrative remedies are irrelevant.
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Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 3 of 30
14. Admitted. By way of further response, if a grievance is rejected, an inmate has only five (5) working days to re-file the grievance. See D. Motion for Summary Judgment Appx. (“D. Appx.) A at p.1-4.
15. Admitted in part, denied in part. The purpose of the implementation of DC-ADM 804 is unknown to plaintiffs, nor are the reasons articulated in paragraph 15 written in DC-ADM 804 as stated, see D Appx. A, and it is only admitted that this is the statement made by Keri Moore in her Declaration. See D. Appx. E at p.2 ¶5. It is specifically denied that “An inmate must file complaints and appeals in the place and at the time, the prison’s administrative rules require” as it is a legal conclusion.
16. Admitted in part, denied in part. It is admitted that the Inmate Handbook includes a section regarding the grievance policy, but it is denied that the Inmate Handbook provides complete information regarding the Grievance Policy requirements and instead, refers inmates to DC-ADM 804. See DOC Inmate Handbook, 2017 edition, Ex. X (excerpt), complete handbook available at http://www.cor.pa.gov/About%20Us/Documents/DOC%20Policies/2017%20DOC%20Inmate% 20Handbook.pdf.
17. Admitted in part, denied in part. It is admitted that the Declaration of Keri Moore states that when a grievance or appeal is received from an inmate, staff put certain information into a Central Grievance Tracking System, but it is specifically denied that the Central Grievance Tracking System is a complete record of all grievances filed.
18. Admitted in part, denied in part. It is admitted only that the Declaration of Keri Moore makes this statement.
3

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 4 of 30
19. Admitted in part, denied in part. It is admitted only that the Declaration of Keri Moore makes this statement.
20. Admitted in part, denied in part. It is admitted only that the Declaration of Keri Moore makes this statement.
21. Admitted in part, denied in part. It is admitted only that the Declaration of Keri Moore makes this statement.
22. Admitted in part, denied in part. It is admitted only that the Declaration of Keri Moore makes this statement.
23. Admitted in part, denied in part. It is admitted only that the Declaration of Keri Moore makes this statement.
24. Admitted in part, denied in part. It is admitted only that the Declaration of Keri Moore makes this statement.
25. Admitted in part, denied in part. It is admitted only that the Declaration of Keri Moore makes this statement.
26. Admitted in part, denied it part. It is admitted that many inmates’ grievances relating to Hepatitis C treatment are referred to the Bureau of Health Care Services (BHCS), but Plaintiffs do not have further knowledge on whether all of these grievances are referred to the BHCS.
27. Admitted in part, denied in part. It is admitted that Keri Moore and Richard Wenhold state this in their Declarations, but it is denied that the tracking is complete or accurate. For example, Inmate No. JZ-3979 is named Plaintiff Daniel Leyva, who filed his first grievance on January 13, 2015 (Grievance No. 546641), which is not listed in the excel spreadsheet. Compare P Ex. U and D. Appx. B. Plaintiff Leyva filed a follow-up grievance on April 7, 2015
4

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 5 of 30
(Grievance No. 561975), which is also not listed in the excel spreadsheet, even though Defendants themselves produced this document in discovery and have attached it as an exhibit to their brief. Compare D. Appx. B and C.
28. Admitted in part, denied in part. It is admitted that the information about grievances is kept on an excel spreadsheet, but denied that the information contained is complete or accurate.
29. Admitted. 30. Neither admitted nor denied. Plaintiffs have no additional information on this matter, aside from Richard Wenhold’s Declaration. 31. Denied. Plaintiff Leyva filed his first grievance regarding Hepatitis C treatment on January 13, 2015. The grievance filed on April 27, 2015 was a follow-up grievance to the one filed in January 13, 2015. See P. Ex. U (Leyva Grievance dated 1/13/15). 32. Admitted in part, denied in part. It is admitted that a final decision for Grievance No. 561975 for Plaintiff Leyva was issued on September 8, 2015. However, he received a final response to Grievance No. 546641, his first grievance seeking Hepatitis C treatment, on January 13, 2015, where his grievance was upheld (and therefore there is no obligation to appeal when the inmate is upheld). Plaintiff Leyva then received a letter from BCHS on March 13, 2016. See Leyva grievances, Ex. U. 33. Denied. As discussed above in paragraph 27, the excel spreadsheet is incomplete and inaccurate. 34. Admitted in part, denied in part. It is admitted only that these inmate numbers are listed in the excel spreadsheet.
5

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 6 of 30
35. Denied. It is specifically denied that AY-3342 filed duplicative grievances. Inmate No. AY-3342 is named Plaintiff Chimenti, and while they relate to Hepatitis C treatment, they are not duplicative. In fact, the grievance system can (and frequently does) reject duplicative grievances.
36. Denied as this is a legal conclusion. 37. Denied as this is a legal conclusion. 38. Admitted in part, denied in part. It is admitted only that the documents show a “Completion Date” of after June, 2015, but contains no further information or content for the first three, and only portions of a response for the last two. 39. Denied. As discussed above in paragraph 27, the excel spreadsheet is incomplete and inaccurate, and therefore this conclusion is likely incomplete and inaccurate. 40. Admitted in part, denied in part. It is admitted that the most recent Hepatitis C protocol was issued and made effective on November 7, 2016, but it is denied that DOC treats all inmates on an individual basis with chronic Hepatitis C in accordance with its Hepatitis C protocol. 41. Admitted in part, denied in part. It is admitted that the DOC screens all inmates for Hepatitis C, and does keep track of those inmates, and sends them to a chronic care clinic. Plaintiffs deny that the DOC educates inmates regarding the policy, except when inmates make inquiries while seeking medical treatment or file a grievance. 42. Denied. Inmates with chronic Hepatitis C are reviewed, but Plaintiffs assert that the DOC is rationing DAAD treatment. 43. Denied. 44. Denied.
6

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 7 of 30
45. Admitted in part, denied in part. It is admitted that the Hepatitis C Review Committee developed the Hepatitis C protocol. It is denied that the DOC protocol is the same as the federal Bureau of Prisons (BOP) protocol as there are differences. See Noel Dep. Tr. Ex. H, 82:11-15. It is also denied that the DOC protocol prioritizes treatment.
46. Admitted. 47. Admitted. By way of further explanation, Dr. Noel has the “ultimate responsibility” on the Hepatitis C Review Committee to approve treatment. See Noel Dep. Tr. Ex. H, 156:12-19. 48. Admitted, except that the company is called “Correct Care Solutions,” not “Correction Care Solutions.” To further clarify, Correct Care solutions currently holds the contract to provide medical services, but previously the medical services were contracted with Wexford Health Services. See Noel Dep. Tr. at 8:6-8; 175:5-13. 49. Admitted. 50. Admitted. 51. Admitted. 52. Admitted. 53. Admitted in part, denied in part. It is admitted that the DOC began treating some inmates when it issued its Interim Hepatitis C Protocol, but it is denied that the DOC initially started treating people based on fibrosis score. Rather, the DOC imposed additional criteria such that even individuals with F-4 fibrosis score did not receive the treatment, such as Plaintiff Chimenti. See Interim Protocol, Ex. P.
7

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 8 of 30
54. Neither admitted nor denied. The DOC has informed Plaintiffs that it intends to start approving and treating individuals with an F-2 fibrosis score, but has not provided documentation of this plan.
55. Admitted in part, denied in part. It is admitted that this is what the DOC represents that it will do, but some inmates have complained that periodic testing is untimely.
56. Admitted in part, denied in part. While the DOC has stated they plan on treating other inmates with lower fibrosis scores, it is denied that this has or will happen. To date, no definitive plan or time frames have been presented.
57. Admitted in part, denied in part. While the DOC has stated they plan on treating other inmates with lower fibrosis scores, it is denied that this has or will happen. To date, no definitive plan or time frames have been presented.
58. Admitted in part, denied in part. While treating inmates with Hepatitis C may require some more work than writing a prescription, it is not unlike prescribing treatment of other medical conditions, and treatment of Hepatitis C is now based on an algorithm and is fairly straightforward. See Trooskin Dep. Ex. J, 63:7-64:2.
59. Admitted. 60. Admitted in part, denied in part. For further clarification, it is admitted that Dr. Cowan reviews the information for each patient (not necessarily the whole medical file), then considers other factors such as whether additional tests or a vaccine is needed. See Cowan Dep. Ex. D, 36:13-38:19. 61. Denied. 62. Denied. 63. Admitted.
8

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 9 of 30
64. Admitted. 65. Admitted. 66. Admitted. 67. Admitted in part, denied in part. It is admitted that the exact number does change, but Plaintiffs are unaware of any large fluctuations in numbers. 68. Admitted. 69. Admitted. 70. Admitted. 71. Admitted. 72. Admitted. 73. Admitted. 74. Admitted. 75. Admitted in part, denied in part. There is some correlation of the APRI score to fibrosis, but it is an indirect marker. In certain ranges, the correlation between APRI score and fibrosis level can be significantly inaccurate, in the range of 48 percent. See Cowan Dep. Tr. 42:5-43:7. 76. Admitted in part, denied in part. It is admitted that there is some correlation as suggested, but this correlation is imprecise. See P. Br. at Part IV.B.2. 77. It is admitted that there is some correlation as suggested, but this correlation is imprecise. See P. Br. at Part IV.B.2. 78. It is admitted that there is some correlation as suggested, but this correlation is imprecise. See P. Br. at Part IV.B.2.
9

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 10 of 30
79. It is admitted that there is some correlation as suggested, but this correlation is imprecise. See P. Br. at Part IV.B.2.
80. Admitted. 81. Admitted. 82. Admitted. 83. Admitted. 84. Admitted. 85. Admitted. 86. Admitted. 87. Denied. It is denied that these numbers are accurate due to the insensitivity of the APRI score. See P. Br. at Part IV.B.2. 88. Admitted. 89. Admitted in part, denied in part. It is denied that this is an accurate number of the individuals who have exhausted the administrative grievance system. It is admitted that these are the APRI scores calculated for these individuals. Furthermore, for the inmate that allegedly refused a blood test, the DOC has the results from prior blood tests that indicate an APRI score of 0.5-1.0. 90. Denied. 91. Admitted. 92. Denied. The DOC has provided previous lab test results through discovery for this individual that also provide an APRI score. 93. Denied. 94. Denied.
10

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 11 of 30
95. Denied. 96. Denied. Plaintiffs do not know what a “self-funded entity” is. 97. Denied. 98. Denied. By way of further response, Plaintiffs are not alleging a lack of screening or testing for Hepatitis C. 99. Admitted. 100. Admitted in part, denied in part. It is admitted that the DAADs currently cost approximately $30,000 to $45,000 per individual treatment regime as of July 2017. Plaintiffs deny that the total cost in one fiscal year would amount to $150 million, which presumably is the total cost if the DOC treated 5000 inmates in one year, because the DOC deliberately withholds treatment from inmates with chronic Hepatitis C, and has not spent this amount in the prior year(s). Furthermore, with the advent of a new DAAD that is priced significantly lower than previous treatments, this total amount may be less. See Kendig Dep., Ex. K, at 138; see also P. Br. at footnote 4 for further information. 101. Admitted. 102. Admitted. 103. Admitted in part, denied in part. It is admitted that Mr. Oppman stated this in his deposition, but Defendants have not provided documents or testimony that demonstrate this fact. 104. Denied. 105. Admitted. 106. Admitted. 107. Admitted. 108. Admitted.
11

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 12 of 30
109. Admitted. 110. Admitted. 111. Denied. 112. Denied. 113. Denied. 114. Denied. 115. Denied. Further, this includes a legal conclusion not applicable for a statement of facts. 116. Admitted in part, denied in part. It is admitted that F-0 indicates less or limited fibrosis but denies that this means an individual has a healthy liver. Furthermore, a person may experience or suffer from extrahepatic symptoms even at lower fibrosis levels. See Trooskin Dep. Ex. J, 83-84. 117. Admitted. 118. Admitted in part, denied in part. It is admitted only that F-2 indicates an intermediate level of fibrosis. See Trooskin Rep. Ex. A at 2. 119. Denied. 120. Admitted in part, denied in part. See Trooskin Dep. Ex. J, 121. Admitted. By way of further response, this is similar to the process in prescribing any medication. See Trooskin Dep. Ex. J, 63:10-20. 122. Admitted in part, denied in part. It is admitted only that Dr. Kendig stated this in his report for Defendants, but denies that the fiscal challenge of treating all inmates with DAADs is “unlike any other challenge presented previously in correctional medicine.”
12

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 13 of 30
123. Admitted in part, denied in part. It is admitted only that Dr. Kendig made a statement similar to this in his deposition.
124. Denied. Dr. Kendig testified that for individuals at F-0 and F-1, the BOP (United States) deferred treatment of interferon for DAADs, and admitted that a different balance existed due to the side effects associated with interferon. See Kendig Dep. Ex. K, 99:1-22.
125. Admitted. By way of further response, Dr. Kendig also did not review any medical records. See Kendig Report, Ex. B at 4.
126. Admitted. 127. Admitted in part, denied in part. Dr. Trooskin receives a grant from Gilead that links people with Hepatitis C to overcome barriers to get medical care, not just DAADs, specifically those with barriers to care such as lack of insurance, homelessness, and mental health issues, and more simple things such as the ability to travel to an appointment. See Dr. Trooskin Dep. Ex. J, 18:3-20. 128. Admitted in part, denied in part. Defendants’ statement is inaccurate. Dr. Trooskin testified she is an advocate for people with Hepatitis C, and that she follows the AASLD/IDSA guidelines, which recommends that everybody be treated for Hepatitis C. See Trooskin Dep. Ex. J, 21:7-14. 129. Denied. Furthermore, this is a credibility determination inappropriate for a Statement of Facts. 130. Admitted. 131. Denied. This is a misstatement of Dr. Trooskin’s testimony. Dr. Trooskin testified that the risks and benefits had to be weighed with prescribing prior medications (interferon-based therapy) which had side effects, possible contraindications, and a lower cure
13

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 14 of 30
rate with a possible new treatment that would cause less harm to patients. See Dr. Trooskin Dep. Ex. J, 87:25 – 88:22.
132. Denied. Furthermore, this is a credibility determination inappropriate for a Statement of Facts.
133. Denied. This is a misstatement of Dr. Trooskin’s testimony. Dr. Trooskin testified that she did not review individual medical records of Pennsylvania DOC inmates. See Trooskin Dep. Ex. J.
134. Admitted in part, denied in part. Dr. Trooskin responded “to some extent, yet” but then clarified that the situation has been changing such that starting in January 2018, Medicaid will be opening up coverage to individuals at F-0. See Dr. Trooskin Dep. Ex. J, 27:9 – 28:25.
135. Admitted. 136. Admitted. By way of further response, Dr. Cecil is Plaintiff Chimenti’s expert witness for his individual damage claims only. 137. Admitted. By way of further response, Dr. Cecil’s wrote, “Harvoni cured his HCV two years late and the delay irreparately worsened Mr. Chimenti.” See Cecil Report Ex. Q at 1. 138. Admitted. 139. Admitted. 140. Admitted. 141. Admitted. 142. Admitted.
14

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143. Admitted in part, denied in part. The AASLD guidelines note that there may be settings where there are factors that limit access to medications and the ability to deliver them to patients may consider which patients should be treated first. See AASLD guidelines Ex. C.
144. Admitted. 145. Admitted. By way of further response, the Department of Veterans Affairs also notes that the natural history of HCV is variable. See D. Appx. Y at 46. 146. Denied. Currently all veterans with Hepatitis C in the care of the Department of Veterans Affairs are eligible for treatment regardless of the stage of the patients’ liver disease. See Department of Veterans Affairs New Release, VA Expands Hepatitis C Drug Treatment, dated March 9, 2016, available at https://www.va.gov/opa/pressrel/pressrelease.cfm?id=2762; VA Fact Sheet, September 2017, available at https://www.hepatitis.va.gov/pdf/VA-HCV-FactSheet.pdf. 147. Admitted. 148. Admitted.
STATEMENT OF ADDITIONAL FACTS 149. Hepatitis C is a viral infection that attacks the liver and causes hepatitis, or liver inflammation. Am. Compl. at ¶ 17; see also Mayo Clinic Staff, Hepatitis C Overview, MAYO CLINIC, http://www.mayoclinic.org/diseases-conditions/hepatitis-c/home/ovc-20207365 (last visited Sep. 25, 2017; Hepatitis C Fact Sheet, World Health Organization, http://www.who.int/mediacentre/factsheets/fs164/en/ (last updated July 2017). 150. Hepatitis C can significantly impair the liver’s ability to assist the body in digesting essential nutrients, filtering toxins from the blood, and preventing disease. Am. Compl. at ¶ 17.
15

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 16 of 30
151. An acute infection occurs within the first six months of exposure to the virus and, for most of those infected, leads to chronic Hepatitis C infection. Id.
152. Hepatitis C infections are spread by transmitting blood from a person infected with Hepatitis C to another person. See Trooskin Rep. Exhibit (Ex.) A at 2.
153. Some of the major means of transmission are the sharing of needles for injecting drugs, tattooing or piercing, being born to a mother with Hepatitis C, transfusion with infected blood or blood products, and sexual contact with a person infected with Hepatitis C. Id.
154. Any delay in treatment or rationing of DAAs for treatment “cannot be justified on any medical basis” because each day without treatment increases the risk of transmitting Hepatitis C to others and increases the likelihood of developing more serious medical problems. Id. at 4-5.
155. Hepatitis C is the leading cause of cirrhosis (the irreversible scarring of liver tissue that can cause symptoms such as swelling, increased likelihood of bruising, jaundice, itching, nausea, and problems with concentration and memory) and liver cancer, making it the most common cause of liver transplants. Id.
156. Liver transplants are painful, carry a risk of significant complications, and are nearly impossible for prisoners to obtain. Am. Compl. at ¶ 21.
157. Transplants also result in lower recovery rates than treatment with DAA drugs and are very costly. Id.; Mayo Clinic Staff, Hepatitis C Treatment, MAYO CLINIC, http://www.mayoclinic.org/diseases-conditions/hepatitis-c/diagnosis-treatment/treatment/txc20207409 (last visited Sep. 25, 2017).
158. Chronic Hepatitis C infections can also cause serious chronic liver disease, liver fibrosis (the scarring of liver tissue), extrahepatic conditions (such as diabetes, muscle damage,
16

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nerve damage, heart disease, fatigue, depression, nausea, and problems with concentration and memory), and death. See Trooskin Rep. Ex. A, 2; Trooskin Dep. Ex. J, 83-84.
159. More than 20,000 people die each year as a result of Hepatitis C -- more than any other infectious disease. See Trooskin Rep. Ex. A, 2.
160. Beginning in 2011, the FDA approved the use of several “breakthrough therapies” in the form of DAA medications that can cure Hepatitis C: Harvoni® (ledipasvir-sofosbuvir), Olysio® (simeprevir), Sovaldi® (sofosbuvir), Viekira Pak® (ombitasvir/paritaprevir/ritonavir plus dasabuvir), Zepatier® (elbasvir/grazoprevir), and Epclusa® (Sofosbuvir/Velpatasvir). Trooskin Rep., Ex. A, 3.
161. Over 95% of individuals with Hepatitis C treated with Harvoni are now cured of the infection. Id.
162. Individuals treated with these DAAs suffer no, or minimal, side effects. Id. 163. The leading liver disease and Hepatitis C treatment medical organizations, the American Association for the Study of Liver Diseases (“AASLD”) and the Infectious Diseases Society of America (“IDSA”), have recommended that DAAs be used to treat all individuals with chronic Hepatitis C and have specifically confirmed that treatment should not be reserved for individuals with advanced states of the infection. Trooskin Rep., Ex. A, 3; see When and in Whom to Initiate HCV Therapy, AASLD AND IDSA HCV GUIDANCE, http://www.hcvguidelines.org/evaluate/when-whom (last updated Sep. 21, 2017), Ex. C. 164. Several other institutions have also recommended or instituted this course of treatment, further establishing the use of DAAs as the standard of care for chronic Hepatitis C, including the Center for Disease Control (“CDC”), Medicare, and the Veterans Administration (“VA”). Id. These institutions -- particularly the AASLD, IDSA, CDC, and VA -- are the same
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institutions the DOC’s medical provider relies on for treatment recommendations. Cowan Dep. Ex. D at 16-19, 24-25.
165. The FDA has recently approved Mavyret, which is market priced at 40% the price of other DAAs. Max Nisen, AbbVie Wages HCV Drug-Price War on Gilead, BLOOMBERGGADFLY, https://www.bloomberg.com/gadfly/articles/2017-08-07/abbvie-mavyretprice-threatens-gilead-hepatitis-dominance (Aug. 7, 2017 8:00 AM) (“AbbVie's $13,200 monthly price for Mavyret looks like a stunning discount to the roughly $31,500 per month Gilead charges for its best-selling Harvoni.”); Reuters Staff, FDA Approves AbbVie’s Hepatitis C Drug, REUTERS, https://www.reuters.com/article/us-abbvie-fda/fda-approves-abbvies-hepatitis-cdrug-idUSKBN1AJ2SE (Aug. 3, 2017 4:03 PM).
166. At the time when plaintiffs filed their Class Action Complaint on June 12, 2015, the Defendants had ceased all medical treatment for Hepatitis C, providing neither the previous triple therapy (boceprevir or telaprevir with interferon) nor DAAs, and had no policy for treating any inmate diagnosed with chronic Hepatitis C with DAAs. See Class Action Compl. (Docket No. 1) at 6-11; see also Chimenti Med. Rec. Ex. S.
167. When inmates complained or filed grievances about Hepatitis C treatment, they were told that the “DOC/BHCS is re-evaluating [their] treatment protocol for Hepatitis C given the new guidance issued by the [AASLD] and the [IDSA].” See, e.g., Letter to Daniel Leyva from Christopher Oppman (“Leyva Letter”), Ex. E at 1; Letter to David Maldonado from Christopher Oppman (“Maldonado Letter”), Ex. F at 1.
168. On November 20, 2015, the Department of Corrections adopted an interim Hepatitis C policy. See Ex. P.
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169. On November 7, 2016, the Department of Corrections adopted a policy for treating patients with chronic Hepatitis C (“Hepatitis C Protocol” or “Protocol”) that applies to all inmates diagnosed with chronic Hepatitis C. See “DOC Access to Health Care Procedures Manual, Section 20 – Hepatitis C Protocol,” (Nov. 7, 2016) (“Hepatitis C Protocol”), Ex. G.
170. This Hepatitis C policy provides the “clinical guidelines for the diagnosis, management, and treatment of inmate patients with chronic Hepatitis C.” Id. at 20-1.
171. Individuals with chronic Hepatitis C are diagnosed on a fibrosis level scale of F-0 to F-4, with the F-4 diagnosis as the most serious stage of the infection. Am. Compl. ¶ 31; see Trooskin Rep. Ex. A at 2.
172. Individuals at F-3 and F-4 are considered the sickest of the patients who have Hepatitis C. See Cowan Dep. Ex. D, 60.
173. Dr. Kendig testified in his deposition that treating individuals at F-3 and F-4 was “medically necessary.” See Kendig Dep. Ex. K, 72 (“I would argue that treating F-3 and F-4 is medically necessary.”)
174. Individuals at early stages of Chronic Hepatitis C often suffer from serious physical and mental symptoms, and, without treatment, most of them will progress to high fibrosis levels. Id. at ¶¶ 31-32; see Trooskin Dep. Ex. J, 83-85; Trooskin Rep. Ex. A at 2.
175. Pennsylvania DOC inmates at stage F-2 are not currently being treated. See Trooskin Rep., Ex. A, 2; Cowan Dep. Ex. D, 12; Decl. of Richard Wenhold, Ex. I.
176. Dr. Kendig could not point to any case file that showed treatment before the inmate was at F-3 or F-4. Id. 89-91.
177. Pennsylvania DOC inmates at stages F-0 and F-1 are not currently being treated. Id.
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178. Approximately 5% of all inmates with HCV have been provided with DAA treatment under the Protocol. See Trooskin Rep. Ex. A, 9.
179. Inmates at stages F-0, F-1, and F-2 have over a 70% chance of progressing to serious fibrosis.
180. Inmates at F-0 and F-1 constitute the largest part of the class of the approximate 5,500 diagnosed inmates. See Trooskin Rep., Ex. A, 2; Cowan Dep. Ex. D, 12; Decl. of Richard Wenhold, Ex. I.
181. The DOC relies on the APRI score for determining whether an individual qualifies for DAA treatment. See Noel Dep. Ex. H, 85, 92, 99, 108.
182. The APRI score is a calculation of the aspartate aminotransferase and platelet·count. Cowan Dep. Ex. D, 42:1-3.
183. An APRI score between 1.5 and 2 only has a sensitivity accuracy of 48 percent, where it may miss over half the number of individuals who have cirrhosis. Cowan Dep. Ex. D, 42:5-20.
184. An APRI score of 1 may miss approximately 23 percent of patients of cirrhosis. Cowan Dep. Ex. D, 42:21-43:2.
185. Dr. Kendig referenced a study that showed that 48% of patients with APRI scores at or above 1.0 were at a significantly higher F score. See Kendig Dep. Ex. K, 55-56.
186. In the data provided by the DOC, 179 patients were listed without any APRI score. See Kendig Dep. Ex. K, 71.
187. Dr. Kendig stated that any prioritization protocol requires accurate F-scores. Id. at 65.
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188. The DOC does not routinely use more precise tests, including FibroScan, a type of ultrasound known as “transient elastography,” that all experts credit as the most reliable indicator of fibrosis levels. See Trooskin Rep., Ex. J, 8; Kendig Dep., Ex. K, 61-62; 66-67.
189. The Hepatitis C Protocol is implemented by the Hepatitis C Treatment Committee, which consists of the DOC Bureau of Health Care Services Chief of Clinical Services, the Statewide Medical Director for the medical vendor (currently Correct Care Solutions), and the Bureau of Health Care Services Infection Control Coordinator. See Hepatitis C Protocol, Ex. G, 20-10; Noel Dep. Ex. H, 18.
190. The Chief of Clinical Services, currently Dr. Noel, is a final decision-maker in authorizing DAA treatment for any particular inmate. Noel Dep., Ex. H, 187.
191. Dr. Noel consults with the medical contractor’s medical director (then Dr. Cowan) in determining whether to authorize treatment for a particular inmate. Id.
192. In discussions leading up to the adoption of the protocol, Dr. Scharff, then the DOC Chief of Clinical Services, Bureau of Health Care Services, and Eugene Ginchereau, Assistant State Medical Director, provided Dr. Noel with suggested guidelines as to which patients should be provided DAA treatment. See Noel Dep. Ex. H, 81-82; see also Noel emails, Ex. L.
193. These guidelines advised that inmates with an APRI score at or greater than 1.0 should be treated. See Noel Dep. Ex. H, 81-82; see also Noel emails, Ex. L.
194. Dr. Noel rejected that standard—not because the medical condition did not warrant DAA treatment—but because it created too large a number of inmates to be treated. Id.
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195. On February 18, 2015, Dr. Noel stated in an email that use of elastography science would create “a bucket of potential patients which is too large to treat.” Noel email, Ex. L.
196. Elastography is the “gold standard” for determining fibrosis levels. See Cowan Dep. Ex. D, 42-43.
197. Christopher Oppman, the Deputy Secretary for Administration at the DOC, is in charge of financial and other major administrative matters involving delivery of health services to inmates. See Oppman Dep. Ex. N, 6-11.
198. Oppman testified that the Hepatitis C treatment budget is not based on financial costs, but rather on administrative factors such as the number of inmates who could be treated on a yearly basis. Oppman Dep., Ex. N, 25-27; see also Oppman Interrogatories Response, Ex. 0.
199. Defendants provided to plaintiffs all DOC emails over the three-year period leading up to the adoption of the Hepatitis C Protocol and not a single one of these hundreds of emails references any administrative or security concern in the discussions of treatment protocols. See Cowan Dep., Ex. D, 23-41.
200. In follow-up discovery, the DOC defendants were unable to provide even a single document that referenced any such concerns. See P. Request for Prod. Of Doc. and Discovery Follow-up Correspondence, Ex. M.
201. The DOC compiles a tracking spreadsheet that records medical information that is relevant to the DAA prescription process. See D. Appx. B.
202. Dr. Cowen conceded that administrative steps such as transfer of inmates for medical testing; further medical workups to determine which DAA was appropriate; elastography testing and other measures that were necessary before the DAA could be
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prescribed; were not necessary in a system of universal treatment, given the data available to medical staff due to screening and monitoring of inmates with Chronic Hepatitis C. See Cowan Dep., Ex. D, 23-42; 60-61.
203. Dr. Kendig noted that inmates at F-1 and F-0 whose conditions would rarely need special medical attention with respect to possible contra-indications to DAA treatment. See Kendig Dep., Ex. K, 125-131.
204. Dr. Trooskin testified that given the screening and monitoring that the DOC provides for this class of patients, universal treatment could be provided for the entire class within a 12-18 month period. See Trooskin Dep., Ex. J, 65.
205. Dr. Kendig stated that the assessment of the actual financial costs of prioritization (as opposed to universal treatment) involves “an extremely complicated calculation.” Kendig Dep., Ex. K, 137.
206. Dr. Kendig conceded that there “can be significant cost benefits to treatment.” Id. at 137-138.
207. The current Hepatitis C protocol does not require DAA treatment for any specific individual or even for classes of inmates and the current practice of treating those at F-3 and F-4 could be changed at any time and for any reason. See Hepatitis C Protocol, Ex. G; Trooskin Dep. Ex. A, 8-9.
208. In responding to grievances filed by each of the named plaintiffs, the DOC explicitly stated that their care was governed by “community standards of care” for this disease. See Cowan Dep., Ex. D, 19-21; see also Letter to Leyva, Ex. E; Letter to Maldonado, Ex. F.
209. The contracts between the DOC and its medical provider specify community standards of care. See Noel Dep., Ex. H, 13-16; 19-20.
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210. Significant numbers of patients at F-0 to F-2 are suffering from serious medical symptoms, both hepatic and extra-hepatic. Trooskin Rep., Ex. A, 5; See also Trooskin Dep., Ex. J, 47-48.
211. HCV is known to have extrahepatic manifestations, described as effects on organ systems outside the liver. Id.
212. Without treatment, individuals may be needlessly exposed to depression, fatigue, sore muscles, joint pain, kidney injury, diabetes or glucose intolerance, certain types of rashes or autoimmune diseases. Id.
213. Without treatment, individuals with HCV are at increased risk of developing cirrhosis, liver cancer and liver failure requiring transplant. Furthermore, once individuals develop advanced liver disease they must undergo cancer screening at regular intervals for the rest of their life even after they are cured of their HCV. Id.
214. Delaying treatment, even for those at F-0 and F-1, has a variety of adverse effects including increasing the risk of death, causing irreversible liver damage, and needlessly prolonging suffering associated with the disease. Trooskin Rep., Ex. A, 6.
215. From a public health perspective, observation without treatment risks spreading the disease to others. Id.
216. Delaying treatment while that individual’s liver degrades significantly increases the risk of death from cancer, liver failure and a liver transplant. Id.
217. Once a person reaches a fibrosis score of F3 her chance of getting liver cancer is so significant that it is recommended that, even after having been cured with a DAA, the individual undergo twice yearly liver imaging surveillance for liver cancer. Id; see also Kendig Dep. Ex. K, 143-144.
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218. Delay in treatment can cause damage to other vital organs, and can cause heart attacks, fatigue, joint pain, depression, sore muscles, arthritis, and, at times, premature death. Id., citing Gill, Ghazinian, Manch Gish, Hepatitis C virus as a systemic disease; reaching beyond the liver, HEPATOLOGY INTERNATIONAL, Vol. 9, No. 4 (2015).
219. Dr. Cowan testified that he had no basis to disagree with any of the reasons provided by the AASLD in its official Guidance for the need for universal treatment, including the presence of symptoms at early stages; the increased effectiveness of DAA treatment at the earliest possible point of intervention in the disease cycle; and preventing otherwise significant suffering, preventable cancer, liver failure, and death. See Cowan Dep., Ex. D, 62-63.
220. Dr. Noel also testified that he had no basis to disagree with any of the reasons provided by the AASLD in its official Guidance for the need for universal treatment, including the presence of symptoms at early stages; the increased effectiveness of DAA treatment at the earliest possible point of intervention in the disease cycle; and preventing otherwise significant suffering, preventable cancer, liver failure, and death. See Noel Dep., Ex. H, 46-50.
221. Dr. Noel, Dr. Cowan and Dr. Kendig have all acknowledged the point made by Dr. Trooskin that patients at F-0 to F-2 can and do suffer from a range of symptoms caused by Chronic Hepatitis C. See, e.g., Kendig Dep., Ex. K, 38-40; 117-119 (significant number of patients at F-0 may have extra –hepatic symptoms); Cowan Dep., Ex. D, 49; 51-53; Noel Dep., Ex. H, 53-59; 125; 142 (severe fatigue can be present at F-1-2).
222. Dr. Kendig agreed that research studies showed that 4.7% of patients at F-2, and 2.3% of patients at F-0 and F-1 would advance to liver failure and/or liver cancer without treatment. See Kendig Dep., Ex. K, 91-96.
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223. Applying that analysis to the DOC Hepatitis C patient list, approximately 420 patients would be in the very high risk category. See Kendig Dep., Ex. K, 91-96.
224. Daniel Leyva’s filed a grievance seeking DAA treatment and it was “upheld.” See Leyva grievances, Ex. U.
Salvatore Chimenti 225. Chimenti began requesting DAA treatment in late 2013 with his treating medical staff. See Chimenti Med. Rec. Ex. S, Progress notes dated 12/13/13; see also Progress notes dated 1/22/14. 226. Chimenti filed grievances in early 2014 seeking DAA treatment. See Chimenti grievance dated May 16, 2014, Ex. U. 227. Chimenti initially was denied treatment due to the lack of a Hepatitis C protocol. See Chimenti Med. Rec. Ex. S, Progress Notes dated 5/27/14. 228. Dr. Kephart wrote in Chimenti’s medical records, “Pt again reminded of previous talk for Hep. C treatment of how treatment on hold.” See Chimenti Med. Rec. Ex. S, Progress Notes dated 5/27/14.; see also Progress Notes dated 9/30/14 (“I explained again however that treatments are officially on hold in PA DOC for Hep C.”). 229. In May or June 2014, Chimenti was denied approval for a medical appointment with a gastroenterologist or hepatologist due to all treatment being stopped pending a new treatment protocol. See Chimenti Med. Rec. Ex. S, Consultation Record dated 6/27/14 and 6/2/14 (“[B]ecause the DOC policy on Hep C treatments has not yet been completed any recommendations by a hepatologist would be moot till policies in DOC is finalized. Therefore collegial denied consult [with hepatologist] at this time.”).
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230. Chimenti was later denied due to the alleged lack of esophageal varices, which was required at that time under the Interim Hepatitis C protocol. See Interim Hepatitis C protocol, Ex. P; Noel email re Chimenti dated 12/28/14, Ex. T.
231. Dr. Noel was consulted about Chimenti’s medical treatment, and made decisions regarding Chimenti’s medical treatment, including whether or not he should receive DAA treatment. See Noel email re Chimenti dated 12/28/14, Ex. T; see also Chimenti Med. Rec., Progress Notes dated 9/30/14 (“I discussed [with] [Chimenti] my attempt to get him to see a hepatologist & previous email to Dr. Noel.”); Progress Notes dated 12/19/14 (“Received email from Dr. Noel explaining CCS policy for Hep C treatment being reviewed & to let Mr. Chimenti know he will have an answer to him shortly.”).
232. In October 2015, Chimenti was informed by Dr. Frommer that he had cancer due to a mass being seen on a CT scan. See Chimenti Dep., Ex. R, 39.
233. Chimenti was told multiple times by Dr. Frommer that Chimenti would not receive treatment unless he underwent a biopsy. See Chimenti Dep. Ex. R, 47.
234. Dr. Agra, also a doctor working at Chimenti’s prison, advised Chimenti not to undergo the biopsy due to the danger it posed. See Chimenti Med. Rec. Ex. S, Progress Notes dated 10/20/15 (“liver biopsy is risky”); Chimenti Dep., Ex. R, 40.
235. Chimenti ultimately consented to a biopsy, but on three separate occasions by three separate radiologists, the biopsy was cancelled due to the inability to conduct the biopsy safely. See Chimenti Dep., Ex. R, 41-46; UPMC Altoona Final Report by Dr. James, 1/14/15 (“Liver lesion which could be an hemangioma and is difficult to biopsy safely given this possibility.”); UPMC – Presbyterian Final Report by Dr. Borhani, dated 2/18/16 (The decision to
27

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 28 of 30 cancel the ultrasound-guided biopsy was discussed with Dr. Rabinovitz.”); UPMC Altoona Final Report by Dr. Shivers, 3/23/16 (“Biopsy of the abnormality was canceled [sic].”).
236. Chimenti ultimately received the DAA treatment in October 2016, about two years after his initial request seeking DAA treatment. See Chimenti Dep. Ex. R, 34.
237. In the meanwhile, Chimenti’s physical condition worsened, including memory loss due to hepatic encephalopathy, extreme fatigue, and the onset of diabetes likely connected to Hepatitis C. See Dr. Cecil Report, Ex. Q; Chimenti Dep., Ex. R, 33-34.
238. Chimenti also has reduced ability to conduct regular daily activities, reports only wanting to sleep, being tired and having no energy, having bone and muscle pain, getting rashes, and swollen legs. See Chimenti Dep., Ex. R, 32-34.
239. Elimination of the Hepatitis C virus through DAA treatment does not eliminate or improve scarring (cirrhosis) of the liver, and therefore, Chimenti continues to suffer. See Chimenti Dep. Ex. R, 32-34.
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DATE: November 2, 2017

Respectfully submitted,
/s/ David Rudovsky David Rudovsky, Attorney No. 15168 Kairys, Rudovsky, Messing & Feinberg LLP 718 Arch Street, Suite 501S Philadelphia, PA 19106 (215) 925-4400
/s/ Su Ming Yeh Su Ming Yeh, PA Attorney No. 95111 Pennsylvania Institutional Law Project 718 Arch Street, Suite 304S Philadelphia, PA 19106 (215) 925-2966
/s/ Stephen Brown Stephen Brown, PA Attorney No. 27829 Christine Levin, PA Attorney No. 37807 Rose Marie Wong, PA Attorney No. 320602 Dechert LLP Cira Centre 2929 Arch Street Philadelphia, PA 19104 (215) 994-2404
Attorneys for Plaintiff

29

Case 2:15-cv-03333-JP Document 101-2 Filed 11/02/17 Page 30 of 30

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

____________________________________

SALVATORE CHIMENTI, et al.,

:

:

CIVIL ACTION NO: 15 Civ. 3333

Plaintiffs,

:

:

v.

:

Judge John R. Padova

:

PENNSYLVANIA DEPARTMENT OF :

CORRECTIONS, et al.

:

(Filed via ECF)

:

Defendants.

:

CERTIFICATE OF SERVICE

I hereby certify that a true and correct copy of Plaintiffs’ Response to Defendants’ Statement of Material Facts and Counterstatement of Materials Facts, was filed at the Clerk’s Office for the United States District Court of the Eastern District of Pennsylvania was served via ECF upon the following on November 2, 2017:

Vincent Mazeski Chief Counsel’s Office Pennsylvania Department of Corrections 1920 Technology Parkway Mechanicsburg, PA Counsel for DOC Defendants

Samuel Foreman Caitlin Goodrich Noah Katz Weber Gallagher Simpson Stapleton Fires & Newby, LLP 2 Gateway Center Suite 1450 Pittsburgh, PA 15222 Counsel for CCS and Wexford Defendants

Respectfully submitted,

/s/Su Ming Yeh Attorney ID: PA 95111 Pennsylvania Institutional Law Project 718 Arch Street, Suite 304 South Philadelphia, PA 19106 smyeh@pailp.org

30

Case 2:15-cv-03333-JP Document 101-3 Filed 11/02/17 Page 1 of 2

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

_______________________________________

)

SALVATORE CHIMENTI,

)

)

Plaintiff,

)

CIVIL ACTION

v.

)

)

No. 15-3333

PENNSYLVANIA DEPARTMENT

)

CORRECTIONS (DOC), et al.,

)

)

Judge John R. Padova

Defendants.

)

_______________________________________)

EXHIBITS TO PLAINTIFFS’ RESPONSE TO MOTION FOR SUMMARY JUDGMENT

Table of Contents

Exhibit

Description

A

Report of Dr. Stacey Trooskin

B

Report of Dr. Kendig

C

AASLD Guidance

D

Deposition Transcript: Dr. Cowan

E

Letter, Mr. Oppman to Plaintiff Leyva

F

Letter, Mr. Oppman to Plaintiff Maldonado

G

DOC Hepatitis C Protocol

H

Deposition Transcript: Dr. Noel

I

Declaration of Richard Wenhold

J

Deposition Transcript: Dr. Trooskin

K

Deposition Transcript: Dr. Kendig

L

Email from Dr. Noel

Case 2:15-cv-03333-JP Document 101-3 Filed 11/02/17 Page 2 of 2

M

Discovery documents referencing Hep C treatment

N

Deposition Transcript: Mr. Oppman

O

Oppman responses to interrogatories

P

DOC Interim Hepatitis C protocol

Q

Report of Dr. Cecil

R

Deposition Transcript excerpts: Salvatore Chimenti

S

Medical records excerpts: Salvatore Chimenti

T

Email from Dr. Noel (relating to Chimenti)

U

Chimenti Grievances

V

Levva grievances

W

Inmate C.S. medical records

X

DOC Inmate Handbook (excerpt)

Case 2:15-cv-03333-JP Document 101-4 Filed 11/02/17 Page 1 of 17
EXHIBIT A

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EXHIBIT B

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EXHIBIT C

When and in Whom to Initiate HCV Therapy | HCV Guidance CCaassee22:1:155--ccvv--0033333333--JJPP DDooccuummeenntt19041--56 FFilieledd1101/0/022/1/177 PPaaggee12ooff1101

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HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C

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When and in Whom to Initiate HCV Therapy

Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure and, as such, is expected to benefit nearly all chronically infected persons. When the US Food and Drug Administration (FDA) approved the first interferon-sparing treatment for HCV infection, many patients who had previously been “warehoused” sought treatment. The infrastructure (ie, experienced practitioners, budgeted healthcare dollars, etc) did not yet exist to treat all patients immediately. Thus, the panel offered guidance for prioritizing treatment first for those with the greatest need.
Since that time, there have been opportunities to treat many of the highest-risk patients and accumulate real-world experience regarding the tolerability and safety of interferon-free HCV regimens. More importantly, from a medical standpoint, data continue to accumulate that demonstrate the many benefits, both intrahepatic and extrahepatic, that accompany HCV eradication. Therefore, the panel continues to recommend treatment for all patients with chronic HCV infection, except those with a short life expectancy that cannot be remediated by HCV treatment, liver transplantation, or another directed therapy. Accordingly, prioritization tables have been removed from this section.
Despite the strong recommendation for treatment of nearly all HCV-infected patients, pretreatment assessment of a patient’s understanding of treatment goals and provision of education about adherence and follow-up are essential. A well-established therapeutic relationship between clinician and patient remains crucial for optimal outcomes with direct-acting antiviral (DAA) therapies. Additionally, in certain settings there remain factors that impact access to medications and the ability to deliver them to patients. In these settings, clinicians may still need to decide which patients should be treated first. The descriptions of unique populations discussed in this section may help physicians make more informed treatment decisions for these groups. For additional information, see unique patient populations: Patients With HIV/HCV Coinfection, Patients With Decompensated Cirrhosis, Patients Who Develop Recurrent HCV Infection Post Liver Transplantation, Patients With Renal Impairment, HCV in Children, and HCV Post Kidney Transplant.

Goal of Treatment
RECOMMENDED
The goal of treatment of HCV-infected persons is to reduce all-cause mortality and liverrelated health adverse consequences, including end-stage liver disease and hepatocellular carcinoma, by the achievement of virologic cure as evidenced by a sustained virologic response.

RATING I, A

Recommendation for When and in Whom to Initiate Treatment
RECOMMENDED

RATING

http://www.hcvguidelines.org/evaluate/when-whom

9/29/2017

When and in Whom to Initiate HCV Therapy | HCV Guidance CCaassee22:1:155--ccvv--0033333333--JJPP DDooccuummeenntt19041--56 FFilieledd1101/0/022/1/177 PPaaggee23ooff1101

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Child-Turcotte-Pugh Fibrosis-4 (FIB-4) Glomerular Filtration Rate (GFR) Model For End-Stage Liver Disease (MELD)

Recommendation for When and in Whom to Initiate Treatment

Treatment is recommended for all patients with chronic HCV infection, except those with a

short life expectancy that cannot be remediated by HCV therapy, liver transplantation, or another directed therapy. Patients with a short life expectancy owing to liver disease

I, A

should be managed in consultation with an expert.

Clinical Benefit of Cure
The proximate goal of HCV therapy is SVR (virologic cure), defined as the continued absence of detectable HCV RNA for at least 12 weeks after completion of therapy. SVR is a marker for cure of HCV infection and has been shown to be durable in large prospective studies in more than 99% of patients followed-up for ≥5 years (Swain, 2010); (Manns, 2013). Patients in whom SVR is achieved have HCV antibodies but no longer have detectable HCV RNA in serum, liver tissue, or mononuclear cells, and achieve substantial improvement in liver histology (Marcellin, 1997); (Coppola, 2013); (Garcia-Bengoechea, 1999). Assessment of viral response, including documentation of SVR, requires use of an FDA-approved quantitative or qualitative nucleic acid test (NAT) with a detection level of ≤25 IU/mL.
Patients who are cured of their HCV infection experience numerous health benefits, including a decrease in liver inflammation as reflected by improved aminotransferase levels (ie, alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), and a reduction in the rate of liver fibrosis progression (Poynard, 2002b). Among 3,010 treatment-naive patients from 4 randomized trials who had pretreatment and posttreatment liver biopsies (separated by a mean of 20 months) and were treated with 10 different interferon-based regimens, 39% to 73% of participants who achieved SVR had improvement in liver fibrosis and necrosis (Poynard, 2002b). Additionally, cirrhosis resolved in 49% of the cases. Portal hypertension, splenomegaly, and other clinical manifestations of advanced liver disease also improved. Among HCV-infected persons, SVR is associated with a >70% reduction in the risk of liver cancer (hepatocellular carcinoma [HCC]), and a 90% reduction in the risk of liver-related mortality and liver transplantation (Morgan, 2013); (van der Meer, 2012); (Veldt, 2007).
Cure of HCV infection also reduces symptoms and mortality from severe extrahepatic manifestations, including cryoglobulinemic vasculitis, a condition affecting 10% to 15% of HCV-infected patients (Fabrizi, 2013); (Landau, 2010); (Sise, 2016). HCV-infected persons with non-Hodgkin lymphoma and other lymphoproliferative disorders achieve complete or partial remission in up to 75% of cases following successful therapy for HCV infection (Gisbert, 2005); (Takahashi, 2012); (Svoboda, 2005); (Mazzaro, 2002); (Hermine, 2002). These reductions in disease severity contribute to dramatic reductions in all-cause mortality (van der Meer, 2012); (Backus, 2011). Furthermore, patients who achieve SVR have a substantially improved quality of life, which spans their physical, emotional, and social health (Boscarino, 2015); (Neary, 1999); (Younossi, 2013). Because of the many benefits associated with successful HCV treatment, clinicians should treat HCV-infected patients with antiviral therapy with the goal of achieving SVR, preferably early in the course of chronic HCV infection before the development of severe liver disease and other complications.
Benefits of Treatment at Early Fibrosis Stages (Metavir Stage Less Than F2)
Initiating therapy in patients with lower-stage fibrosis augments the benefits of SVR. In a long-term followup study, 820 patients with biopsy-confirmed Metavir stage F0 or F1 fibrosis were followed for up to 20 years (Jezequel, 2015). The 15-year survival rate was significantly better for those who experienced SVR than for those whose treatment failed or for those who remained untreated (93%, 82%, and 88%, respectively; P =.003). The study results argue for consideration of earlier initiation of treatment. Several modeling studies also suggest a greater mortality benefit if treatment is initiated at fibrosis stages prior to F3 (Øvrehus, 2015); (Zahnd, 2015); (McCombs, 2015).
Treatment delay may decrease the benefit of SVR. In a report of long-term follow-up in France, 820 patients with biopsy-confirmed Metavir stage F0 or F1 fibrosis were followed up for as long as 20 years (Jezequel, 2015). The authors noted rapid progression of fibrosis in 15% of patients during follow-up, and in patients treated successfully, long-term survival was better. Specifically, at 15 years, survival rate was 92% for those with SVR versus 82% for treatment failures and 88% for those not treated. In a Danish regional registry study, investigators modeled treatment approaches with the aim of evaluating the benefit to the region in terms of reductions in morbidity and mortality and HCV prevalence (Øvrehus,

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2015). Although they note that in their situation of low HCV prevalence (0.4%) with approximately 50% undiagnosed, a policy that restricts treatment to those with Metavir fibrosis stage F3 or higher would decrease mortality from HCC and cirrhosis, the number needed to treat to halve the prevalence of the disease is lower if all eligible patients receive treatment at diagnosis.
A modeling study based on the Swiss HIV cohort study also demonstrated that waiting to treat HCV infection until Metavir fibrosis stages F3 and F4 resulted in 2- and 5-times higher rates of liver-related mortality, respectively, compared with treating at Metavir stage F2 (Zahnd, 2015). A US Veterans Administration dataset analysis that used very limited end points of virologic response dating from the interferon-treatment era suggested that early initiation of therapy (at a fibrosis-4 [FIB-4] score of <3.25) increased the benefit attained with respect to likelihood of treatment success and mortality reduction, and ultimately decreased the number of patients needed to treat to preserve 1 life by almost 50% (McCombs, 2015).
Considerations in Specific Populations
Despite the recommendation for treatment of nearly all patients with HCV infection, it remains important for clinicians to understand patient- and disease-related factors that place individuals at risk for HCVrelated complications (liver and extrahepatic) as well as for HCV transmission. Although these groups are no longer singled out for high prioritization for treatment, it is nonetheless important that clinicians recognize the unique dimensions of HCV disease and its natural history in these populations. The discussions offered below may assist clinicians in making compelling cases for insurance coverage of treatment when necessary.
Persons With Advanced Liver Disease
For persons with advanced liver disease (Metavir stage F3 or F4), the risk of developing complications of liver disease, such as hepatic decompensation (Child-Turcotte-Pugh [CTP] Class B or C [Methods Table 3]
) or HCC, is substantial and may occur in a relatively short timeframe. A large prospective study of patients with cirrhosis resulting from HCV infection examined the risk of decompensation—including HCC, ascites, jaundice, bleeding, and encephalopathy—and found that the overall annual incidence rate was 3.9% (Sangiovanni, 2006). The National Institutes of Health (NIH)-sponsored HALT–C study included a group of 220 patients with cirrhosis resulting from HCV infection who were observed for approximately 8 years. A primary outcome of death, hepatic decompensation, HCC, or an increase in CTP score ≥2 occurred at a rate of 7.5% per year (Everson, 2006); (Di Bisceglie, 2008). Patients with a CTP score of ≥7 experienced a death rate of 10% per year.
Numerous studies have demonstrated that hepatitis C therapy and the achievement of SVR in this population results in dramatic decreases in hepatic decompensation events, HCC, and liver-related mortality (Morgan, 2013); (van der Meer, 2012); (Backus, 2011); (Dienstag, 2011); (Berenguer, 2009); (Mira, 2013). In the HALT-C study, patients with advanced fibrosis secondary to HCV infection who achieved SVR, compared with patients with similarly advanced liver fibrosis who did not achieve SVR, had a decreased need for liver transplantation (HR, 0.17; 95% CI, 0.06-0.46), decreased development of liver-related morbidity and mortality (HR, 0.15; 95% CI, 0.06-0.38), and decreased HCC (HR, 0.19; 95% CI, 0.04-0.80) (Dienstag, 2011). Importantly, persons with advanced liver disease also require long-term follow-up and HCC surveillance regardless of treatment outcome (see Monitoring Patients Who Are Starting Hepatitis C Treatment, Are on Treatment, or Have Completed Therapy).
Given the clinical complexity and need for close monitoring, patients with advanced liver disease that has already decompensated (CTP Class B or C [Methods Table 3] ) should be treated by physicians with experience treating HCV in conjunction with a liver transplantation center, if possible (see Patients with Decompensated Cirrhosis).
Persons Who Have Undergone Liver Transplantation
In HCV-infected individuals, HCV infection of the liver allograft occurs universally in those with viremia at the time of transplantation. Histologic features of hepatitis develop in about 75% of recipients within the first 6 months following liver transplantation (Neumann, 2004). By the fifth postoperative year, up to 30% of untreated patients have progressed to cirrhosis (Neumann, 2004); (Charlton, 1998). A small proportion of patients (4% to 7%) develop an accelerated course of liver injury (cholestatic hepatitis C, associated with very high levels of viremia) with subsequent rapid allograft failure. Recurrence of HCV infection post

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transplantation is associated with decreased graft survival for recipients with HCV infection compared to recipients who undergo liver transplantation for other indications (Forman, 2002).
Effective HCV therapy prior to transplantation resulting in SVR (virologic cure) prevents HCV recurrence post transplantation (Everson, 2003). In addition, complete HCV viral suppression prior to transplantation prevents recurrent HCV infection of the graft in the majority of cases (Forns, 2004); (Everson, 2005). Preliminary data from a study of patients with complications of cirrhosis secondary to HCV infection who were wait-listed for liver transplantation (included patients with MELD scores up to 14 and CTP scores up to 8) found that treatment with sofosbuvir and weight-based ribavirin for up to 48 weeks was well tolerated and associated with an overall posttransplant SVR rate of 70% (Curry, 2015). Posttransplant SVR was nearly universal among patients who had undetectable HCV RNA for 28 days or longer prior to transplantation.
Treatment of established HCV infection post transplantation also yields substantial improvements in patient and graft survival (Berenguer, 2008); (Picciotto, 2007). The availability of effective, interferon-free antiviral therapy has addressed the major hurdles to treating HCV recurrence post transplantation—poor tolerability and efficacy. A multicenter, open-label study evaluated the efficacy of sofosbuvir plus ribavirin to induce virologic suppression in 40 patients after liver transplantation with compensated recurrence of HCV infection. Daily sofosbuvir plus ribavirin for 24 weeks achieved SVR12 in 70% of these patients (Charlton, 2015). No deaths, graft losses, or episodes of rejection occurred. Six patients had serious adverse events, all of which were considered unrelated to the study treatment. There were no drug interactions reported between sofosbuvir and any of the concomitant immunosuppressive agents. In contrast, treatment with sofosbuvir plus ribavirin, with or without peginterferon, in 64 patients with severe, decompensated cirrhosis resulting from recurrence of HCV infection following liver transplantation was associated with an overall SVR12 rate of 59% and a mortality rate of 13% (Forns, 2015). On an intent-to-treat basis, treatment was associated with clinical improvement in 57% and stable disease in 22% of patients. Given the clinical complexity (including drug interactions and the need for close monitoring), patients with liver transplant should be treated by physicians with experience in treating this population (see Patients Who Develop Recurrent HCV Infection Post-Liver Transplantation).
Persons at Increased Risk for Rapidly Progressive Fibrosis and Cirrhosis
Fibrosis progression is variable across different patient populations as well as within the same individual over time. Many of the components that determine fibrosis progression and development of cirrhosis in an individual are unknown. However, certain factors, such as coinfection with HIV or the hepatitis B virus (HBV) and prevalent coexistent liver diseases (eg, nonalcoholic steatohepatitis [NASH]), are wellrecognized contributors to accelerated fibrosis progression (see Table below).
HIV/HCV Coinfection
HIV coinfection accelerates fibrosis progression among HCV-infected persons (Benhamou, 1999); (Macias, 2009); (Konerman, 2014), although control of HIV replication and restoration of CD4 cell count may mitigate this to some extent (Benhamou, 2001); (Bräu, 2006). However, antiretroviral therapy is not a substitute for HCV treatment. In the largest paired-biopsy study, 282 HIV/HCV-coinfected patients with 435 paired biopsies were prospectively evaluated (Konerman, 2014). Thirty-four percent of patients showed fibrosis progression of at least 1 Metavir stage at a median of 2.5 years. Importantly, 45% of patients with no fibrosis on initial biopsy had progression. Finally, a more rapid progression to death following decompensation combined with lack of widespread access to liver transplantation and poor outcomes following transplantation highlight the need for HCV treatment in this population regardless of current fibrosis stage (see Patients with HIV/HCV Coinfection) (Pineda, 2005); (Merchante, 2006); (Terrault, 2012).
HBV/HCV Coinfection
The prevalence of HBV/HCV coinfection is estimated at 1.4% in the United States and 5% to 10% globally (Tyson, 2013); (Chu, 2008). Persons with HBV/HCV coinfection and detectable viremia of both viruses are at increased risk for disease progression, decompensated liver disease, and the development of HCC. HBV/HCV-coinfected individuals are susceptible to a process called viral interference wherein one virus may interfere with the replication of the other virus. Thus, when treating one or both viruses with antiviral drugs, periodic retesting of HBV DNA and HCV RNA levels during and after therapy is prudent, particularly if only one of the viruses is being treated at a time. Treatment of HCV infection in such cases utilizes the

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same genotype-specific regimens as are recommended for HCV monoinfection (see Initial Treatment of HCV Infection). HBV infections in such cases should be treated as recommended for HBV monoinfection (Lok, 2009).
Other Coexistent Liver Diseases
Persons with other chronic liver diseases who have coincident chronic HCV infection should be considered for HCV therapy given the potential for rapid liver disease progression. An interferon-free regimen is generally preferred for immune-mediated liver diseases, such as autoimmune hepatitis, because of the potential for interferon-related exacerbation.
Persons With Extrahepatic Manifestations of Chronic HCV Infection
Cryoglobulinemia
Chronic hepatitis C is associated with a syndrome of cryoglobulinemia, an immune complex and lymphoproliferative disorder that leads to arthralgias, fatigue, palpable purpura, renal disease (eg, membranoproliferative glomerulonephritis), neurologic disease (eg, peripheral neuropathy, central nervous system vasculitis), and reduced complement levels (Agnello, 1992). Because patients with chronic hepatitis C frequently have laboratory evidence of cryoglobulins (>50% in some series), antiviral treatment is imperative for those with the syndrome of cryoglobulinemia and symptoms or objective evidence of end-organ manifestations. Interferon-based regimens can produce clinical remission; however, the adverse effects of interferon may mimic manifestations of cryoglobulinemia (Saadoun, 2014).
Glomerular disease results from deposition of HCV-related immune complexes in the glomeruli (Johnson, 1993). Successful treatment of HCV using interferon-based regimens can reverse proteinuria and nephrotic syndrome but usually does not fully ameliorate azotemia (Johnson, 1994). There is building new evidence of effective resolution of cryoglobulinemia upon clearance of HCV in most patients, making a strong case for HCV treatment in this clinical setting.
Diabetes
The relationship between chronic hepatitis C and diabetes (most notably type 2 diabetes and insulin resistance) is complex and incompletely understood. The prevalence and incidence of diabetes is increased in the context of hepatitis C (White, 2008). In the United States, type 2 diabetes occurs more frequently in HCV-infected patients, with a >3-fold greater risk in persons older than 40 years (Mehta, 2000). The positive correlation between quantity of plasma HCV RNA and established markers of insulin resistance confirms this relationship (Yoneda, 2007). Insulin resistance and type 2 diabetes are independent predictors of accelerated liver fibrosis progression (Petta, 2008). Patients with type 2 diabetes and insulin resistance are also at increased risk for HCC (Hung, 2010).
Successful antiviral treatment has been associated with improved markers of insulin resistance and a greatly reduced incidence of new-onset type 2 diabetes and insulin resistance in HCV-infected patients (Arase, 2009). Most recently, antiviral therapy for HCV infection has been shown to improve clinical outcomes related to diabetes. In a large prospective cohort from Taiwan, the incidence rates of end-stage renal disease, ischemic stroke, and acute coronary syndrome were greatly reduced in HCV-infected patients with diabetes who received antiviral therapy compared with untreated, matched controls (Hsu, 2014). Therefore, antiviral therapy may prevent progression to diabetes in HCV-infected patients with prediabetes, and may reduce renal and cardiovascular complications in HCV-infected patients with established diabetes.
Fatigue
Fatigue is the most frequently reported symptom in patients with chronic hepatitis C, and has a major effect on quality of life and activity level as evidenced by numerous measures of impaired quality of life (Foster, 1998). The presence and severity of fatigue appears to correlate poorly with disease activity, although it may be more common and severe in HCV-infected individuals with cirrhosis (Poynard, 2002a). Despite difficulties in separating fatigue symptoms associated with hepatitis C from those associated with other concurrent conditions (eg, anemia, depression), numerous studies have reported a reduction in fatigue after cure of HCV infection (Bonkovsky, 2007). In the Virahep-C study, 401 patients with HCV infection were evaluated for fatigue prior to and after treatment, using validated scales to

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assess the presence and severity of fatigue (Sarkar, 2012). At baseline, 52% of patients reported having fatigue, which was more frequent and severe in patients with cirrhosis than in those without cirrhosis. Achieving SVR was associated with a substantial decrease in the frequency and severity of fatigue.
A recent analysis of 413 patients from the NEUTRINO and FUSION trials who were treated with a sofosbuvir-containing regimen and achieved SVR12 demonstrated improvement in patient fatigue (present in 12%) from the pretreatment level (Younossi, 2014). After achieving SVR12, participants had marked improvements in fatigue over their pretreatment scores, measured by 3 separate validated questionnaires. Additional studies support and extend these findings beyond fatigue, with improvements in overall health-related quality of life and work productivity observed following successful HCV therapy (Gerber, 2016); (Younossi, 2015b); (Younossi, 2015c); (Younossi, 2015d); (Younossi, 2015e); (Younossi, 2016a).
Dermatologic Manifestations
The reported prevalence of HCV infection in patients with porphyria cutanea tarda approximates 50% and occurs disproportionately in those with cirrhosis (Gisbert, 2003). The treatment of choice for active porphyria cutanea tarda is iron reduction by phlebotomy and maintenance of a mildly iron-reduced state without anemia. However, although improvement of porphyria cutanea tarda during HCV treatment with interferon has frequently been described (Takikawa, 1995), there are currently insufficient data to determine whether treating HCV infection with DAAs and achievement of SVR results in porphyria cutanea tarda improvement.
Lichen planus is characterized by pruritic papules involving mucous membranes, hair, and nails. HCV antibodies are present in 10% to 40% of patients with lichen planus, but a causal link with chronic HCV infection is not established. Resolution of lichen planus has been reported with interferon-based regimens, but there have also been reports of exacerbation with these treatments. Although it is unknown whether DAAs will have more success against lichen planus, treatment with interferon-free regimens would appear to be a more advisable approach to addressing this disorder (Gumber, 1995); (Sayiner, 2017).
Benefit of Treatment to Reduce Transmission
Persons who have successfully achieved SVR (virologic cure) no longer transmit the virus to others. As such, successful treatment of HCV infection benefits public health. Several health models have shown that even modest increases in successful treatment of HCV infection among persons who inject drugs can decrease prevalence and incidence (Martin, 2013a); (Durier, 2012); (Martin, 2013b); (Hellard, 2012). Models developed to estimate the impact of HCV testing and treatment on the burden of hepatitis C at a country level reveal that large decreases in HCV prevalence and incidence are possible as more persons are successfully treated (Wedemeyer, 2014).
There are also benefits to eradicating HCV infection between couples and among families, thus eliminating the perception that an individual might be contagious. In addition, mother-to-child transmission of HCV does not occur if the woman is not viremic, providing an additional benefit of curing a woman before she becomes pregnant (Thomas, 1998). However, the safety and efficacy of treating women who are already pregnant to prevent transmission to the fetus have not yet been established; thus, treatment is not recommended for pregnant women.
The Society for Healthcare Epidemiology of America (SHEA) advises that healthcare workers who have substantial HCV viral replication (≥104 genome equivalents/mL) be restricted from performing procedures that are prone to exposure (Henderson, 2010) and that all healthcare workers with confirmed chronic HCV infection should be treated. For reasons already stated, the achievement of SVR in such individuals will not only eliminate the risk of HCV transmission to patients but also decrease circumstantial loss of experienced clinicians. Given concerns about underreporting of infection and transmission (Henderson, 2010), the availability of effective, all-oral regimens should lead to greater willingness on the part of exposure-prone clinicians to be tested and treated.
Successful treatment of HCV-infected persons at greatest risk for transmission represents a formidable tool to help stop HCV transmission in those who continue to engage in high-risk behaviors. To guide implementation of hepatitis C treatment as a prevention strategy, studies are needed to define the best candidates for treatment to stop transmission, the additional interventions needed to maximize the

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benefits of HCV treatment (eg, preventing reinfection), and the cost-effectiveness of the strategies when used in target populations.
Persons Who Inject Drugs
Injection drug use (IDU) is the most common risk factor for HCV infection in the United States and Europe, with an HCV seroprevalence rate of 10% to 70% (Amon, 2008); (Nelson, 2011). IDU also accounts for the majority of new HCV infections (approximately 70%) and is the key driving force in the perpetuation of the epidemic. Given these facts and the absence of an effective vaccine against HCV, testing and linkage to care combined with treatment of HCV infection with potent interferon-free regimens has the potential to dramatically decrease HCV incidence and prevalence (Martin, 2013b). However, treatment-based strategies to prevent HCV transmission have yet to be studied, including how to integrate hepatitis C treatment with other risk-reduction strategies (eg, opiate substitution therapy, and needle and syringe exchange programs) (Martin, 2013a).
In studies of interferon-based treatments in persons who inject drugs, adherence and efficacy rates are comparable to those of patients who do not use injected drugs. A meta-analysis of treatment with peginterferon, with or without ribavirin, in active or recent injection drug users showed SVR rates of 37% and 67% for HCV genotype 1 or 4 and 2 or 3, respectively (Aspinall, 2013). With the introduction of shorter, better-tolerated, and more efficacious interferon-free therapies, these SVR rates are expected to improve. Importantly, the rate of reinfection in this population is lower (2.4/100 person-years of observation) than that of incident infection in the general population of injection drug users (6.1 to 27.2/100 person-years), although reinfection increases with active or ongoing IDU (6.44/100 person-years) and available data on follow-up duration are limited (Aspinall, 2013); (Grady, 2013).
Ideally, treatment of HCV-infected persons who inject drugs should be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population (Murphy 2015); (Dore, 2016); (Mathei 2016); (Midgard 2016). Regardless of the treatment setting, recent or active IDU should not be seen as an absolute contraindication to HCV therapy. There is strong evidence from various settings in which persons who inject drugs have demonstrated adherence to treatment and low rates of reinfection, countering arguments that have been commonly used to limit treatment access in this patient population (Aspinall, 2013); (Hellard, 2014); (Grebely, 2011). Indeed, combining HCV treatment with needle exchange and opioid agonist therapy programs in this population with a high prevalence of HCV infection has shown great value in decreasing the burden of HCV disease. Elegant modeling studies illustrate high return on the modest investment of addressing this often-ignored segment of the HCV-infected population (Martin, 2013b). These conclusions were drawn before the introduction of the latest DAA regimens. Conversely, there are no data to support the utility of pretreatment screening for illicit drug or alcohol use in identifying a population more likely to successfully complete HCV therapy. These requirements should be abandoned because they create barriers to treatment, add unnecessary cost and effort, and potentially exclude populations that are likely to obtain substantial benefit from therapy. Scaling up HCV treatment in persons who inject drugs is necessary to positively impact the HCV epidemic in the US and globally.
HIV-Infected Men Who Have Sex With Men
Since 2000, a dramatic increase in incident HCV infections among HIV-infected men who have sex with men (MSM) who did not report IDU as a risk factor has been demonstrated in several US cities (van de Laar, 2010); (Samandari, 2017). Recognition and treatment of HCV infection (including acute infection) in this population may represent an important step in preventing subsequent infections. As with persons who inject drugs, HIV/HCV-coinfected MSM who engage in ongoing high-risk sexual practices should be treated for their HCV infection in conjunction with continued education about risk-reduction strategies. In particular, safer-sex strategies should be emphasized given the high rate of reinfection after SVR, which may approach 30% over 2 years in HIV-infected MSM with acute HCV infection (Lambers, 2011).
Incarcerated Persons
Among incarcerated individuals, the rate of HCV seroprevalence ranges from 30% to 60% (Post, 2013) and the rate of acute infection is approximately 1% (Larney, 2013). Screening for HCV infection is relatively uncommon in state prison systems. Treatment uptake has historically been limited, in part because of the toxic effects and long treatment duration of older interferon-based therapies as well as concerns about cost (Spaulding, 2006). In particular, truncation of HCV treatment owing to release from prison has been

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cited as a major limitation to widespread, effective HCV treatment in correctional facilities (Post, 2013); (Chew, 2009). Shorter HCV treatment duration with DAAs reduces stay-related barriers to HCV treatment in prisons. Likewise, the improved safety of DAA regimens diminishes concerns about toxic effects. Coordinated treatment efforts within prison systems would likely rapidly decrease the prevalence of HCV infection in this at-risk population, although research is needed in this area.

Persons on Hemodialysis
The prevalence rate of HCV infection is markedly elevated in persons on hemodialysis, ranging from 2.6% to 22.9% in a large multinational study (Fissell, 2004). Studies in the US found a similarly elevated prevalence rate of 7.8% to 8.9% (CDC, 2001); (Finelli, 2005). Importantly, the seroprevalence of HCV was found to increase with time on dialysis, suggesting that nosocomial transmission, among other risk factors, plays a role in HCV acquisition in these patients (Fissell, 2004). Improved education and strict adherence to universal precautions can drastically reduce nosocomial HCV transmission risk for persons on hemodialysis (Jadoul, 1998), but clearance of HCV viremia through treatment-induced SVR eliminates the potential for transmission.
HCV-infected persons on hemodialysis have a decreased quality of life and increased mortality compared with those who are uninfected (Fabrizi, 2002); (Fabrizi, 2007); (Fabrizi, 2009). HCV infection in this population also has a deleterious impact on kidney transplantation outcomes with decreased patient and graft survival (Fabrizi, 2014). The increased risk for nosocomial transmission and the substantial clinical impact of HCV infection in those on hemodialysis are compelling arguments for HCV therapy as effective antiviral regimens that can be used in persons with advanced renal failure are now available (see Patients with Renal Impairment).

Patients Unlikely to Benefit From HCV Treatment
Patients with a limited life expectancy that cannot be remediated by HCV treatment, liver transplantation, or another directed therapy do not require antiviral treatment. Patients with a short life expectancy owing to liver disease should be managed in consultation with an expert. Chronic hepatitis C is associated with a wide range of comorbid conditions (Butt, 2011); (Louie, 2012). Little evidence exists to support initiation of HCV treatment in patients with a limited life expectancy (<12 months) owing to nonliver-related comorbid conditions. For these patients, the benefits of HCV treatment are unlikely to be realized and palliative care strategies should take precedence (Holmes, 2006); (Maddison, 2011).

Pretreatment Assessment

Recommendation for Pretreatment Assessment
RECOMMENDED
Evaluation for advanced fibrosis using liver biopsy, imaging, and/or noninvasive markers is recommended for all persons with HCV infection, to facilitate decision making regarding HCV treatment strategy and to determine the need for initiating additional measures for the management of cirrhosis (eg, hepatocellular carcinoma screening) (see HCV Testing and Linkage to Care).

RATING I, A

An accurate assessment of fibrosis remains vital, as the degree of hepatic fibrosis is one of the most robust prognostic factors used to predict HCV disease progression and clinical outcomes (Everhart, 2010). Individuals with severe fibrosis require surveillance monitoring for liver cancer, esophageal varices, and hepatic function (Garcia-Tsao, 2007); (Bruix, 2011). In some instances, the recommended duration of treatment is also longer.
Although liver biopsy is the diagnostic standard, sampling error and observer variability limit test performance, particularly when inadequate sampling occurs. Up to one-third of bilobar biopsies had a difference of at least 1 stage between the lobes (Bedossa, 2003). In addition, the test is invasive and minor complications are common, limiting patient and practitioner acceptance. Although rare, serious complications such as bleeding are well recognized.
Noninvasive tests to stage the degree of fibrosis in patients with chronic HCV infection include models incorporating indirect serum biomarkers (routine tests), direct serum biomarkers (components of the extracellular matrix produced by activated hepatic stellate cells), and vibration-controlled transient liver

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elastography. No single method is recognized to have high accuracy alone, and each test must be interpreted carefully. A publication from the Agency for Healthcare Research and Quality found evidence in support of a number of blood tests; however, at best, they are only moderately useful for identifying clinically significant fibrosis or cirrhosis (Selph, 2014).
Vibration-controlled transient liver elastography is a noninvasive way to measure liver stiffness and correlates well with measurement of substantial fibrosis or cirrhosis in patients with chronic HCV infection. The measurement range, however, overlaps between stages (Ziol, 2005); (Afdhal, 2015); (Castera, 2005).
The most efficient approach to fibrosis assessment is to combine direct biomarkers and vibrationcontrolled transient liver elastography (Boursier, 2012); (European Association for the Study of the Liver and Asociacion Latinoamericana para el Estudio del Higado, 2015). A biopsy should be considered for any patient who has discordant results between the 2 modalities that would affect clinical decision making (eg, one shows cirrhosis and the other does not). The need for liver biopsy with this approach is markedly reduced.
Alternatively, if direct biomarkers or vibration-controlled transient liver elastography are not available, the AST-to-platelet ratio index (APRI) or fibrosis-4 (FIB-4) index score can prove helpful (Sebastiani, 2009); (Castera, 2010); (Chou, 2013)—although neither is sensitive enough to rule out substantial fibrosis (Chou, 2013). Biopsy should be considered for those in whom more accurate fibrosis staging would impact treatment decisions. Individuals with clinically evident cirrhosis do not require additional staging (biopsy or noninvasive assessment).

Recommendation for Repeat Liver Disease Assessment
RECOMMENDED Ongoing assessment of liver disease is recommended for persons in whom therapy is deferred.

RATING I, C

Ongoing assessment of liver disease is especially important in patients for whom therapy has been deferred. In line with evidence-driven recommendations for treatment of nearly all HCV-infected patients, several factors must be taken into consideration if treatment deferral is entertained or mandated by lack of medication access. As noted, strong and accumulating evidence argue against deferral because of decreased all-cause morbidity and mortality, prevention of onward transmission, and quality-of-life improvements for patients treated regardless of baseline fibrosis. Additionally, treatment of HCV infection may improve or prevent extraheptatic complications, including diabetes mellitus, cardiovascular disease, renal disease, and B-cell non-Hodgkin lymphoma (Conjeevaram, 2011); (Hsu, 2015); (Torres, 2015), which are not tied to fibrosis stage (Allison, 2015); (Petta, 2016). Deferral practices based on fibrosis stage alone are inadequate and shortsighted.
Fibrosis progression varies markedly between individuals based on host, environmental, and viral factors (Table 1); (Feld, 2006). Fibrosis may not progress linearly. Some individuals (often those aged >50 years) may progress slowly for many years followed by an acceleration of fibrosis progression. Others may never develop substantial liver fibrosis despite longstanding infection. The presence of existing fibrosis is a strong risk factor for future fibrosis progression. Fibrosis results from chronic hepatic necroinflammation; thus, a higher activity grade on liver biopsy and higher serum transaminase values are associated with more rapid fibrosis progression (Ghany, 2003). However, even patients with normal ALT levels may develop substantial liver fibrosis over time (Pradat, 2002); (Nutt, 2000). The limitations of transient elastography and liver biopsy in ascertaining the progression of fibrosis must be recognized.
Host factors associated with more rapid fibrosis progression include male sex, longer duration of infection, and older age at the time of infection (Poynard, 2001). Many patients have concomitant nonalcoholic fatty liver disease. The presence of hepatic steatosis (with or without steatohepatitis) on liver biopsy, elevated body mass index, insulin resistance, and iron overload are associated with fibrosis progression (Konerman, 2014); (Everhart, 2009). Chronic alcohol use is an important risk factor because alcohol consumption has been associated with more rapid fibrosis progression (Feld, 2006). A safe amount of alcohol consumption has not been established. Cigarette smoking may also lead to more rapid fibrosis progression. For more counseling recommendations, see Testing and Linkage to Care.

http://www.hcvguidelines.org/evaluate/when-whom

9/29/2017

When and in Whom to Initiate HCV Therapy | HCV Guidance

Page 10 of 10

CCaassee22:1:155--ccvv--0033333333--JJPP DDooccuummeenntt19041--56 FFilieledd1101/0/022/1/177 PPaaggee1101ooff1101

Immunosuppression leads to more rapid fibrosis progression, particularly in the settings of HIV/HCV coinfection and solid organ transplantation (Macias, 2009); (Konerman, 2014); (Berenguer, 2013). Therefore, immunocompromised patients should be treated even if they have mild liver fibrosis at presentation.
Level of HCV RNA does not correlate with stage of disease (degree of inflammation or fibrosis). Available data suggest that fibrosis progression occurs most rapidly in patients with genotype 3 infection (Kanwal, 2014); (Bochud, 2009). Aside from coinfection with HBV or HIV, no other viral factors are consistently associated with disease progression.
Although an ideal interval for assessment has not been established, annual evaluation is appropriate to discuss modifiable risk factors and update testing for hepatic function and markers for disease progression. For all individuals with advanced fibrosis, liver cancer screening dictates a minimum of evaluation every 6 months.

Table. Factors Associated With Accelerated Fibrosis Progression

Host

Viral

Nonmodifiable
Fibrosis stage Inflammation grade Older age at time of infection Male sex Organ transplant

Genotype 3 infection Coinfection with hepatitis B virus or HIV

Modifiable
Alcohol consumption Nonalcoholic fatty liver disease Obesity Insulin resistance

Last update: September 21, 2017
Ý Previous Page Next Page Þ

Copyright © 2014-2017 by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. All rights reserved.

http://www.hcvguidelines.org/evaluate/when-whom

9/29/2017

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EXHIBIT H

Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 2 of 53 Dr. Paul Noel

Page 1

Page 3

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

- - -

SALVATORE CHIMENTI, : CIVIL ACTION

DANIEL LEVYA, DAVID :

MALDONADO, and all :

others similarly :

situated

:

:

Plaintiff (s) :

:

vs.

:

:

PENNSYLVANIA :

DEPARTMENT OF :

CORRECTIONS, et al. :

:

Defendant (s) : NO. 15-3333

- - -

Oral Deposition of PAUL A. NOEL, M.D.,

taken pursuant to notice, held at Kairys, Rudovsky,

Messing & Feinberg, The Cast Iron Building, 718 Arch

Street, Suite 501 South, Philadelphia, Pennsylvania on

February 24, 2017, beginning at approximately

9:55 a.m., before Michelle Palys, Court Reporter-Notary

Public, there being present. - - -
Any reproduction of this transcript is prohibited without authorization by the certifying agency.

- - KAPLAN, LEAMAN AND WOLFE Registered Professional Reporters Constitution Place 325 Chestnut Street, Suite 909 Philadelphia, Pennsylvania 19106
(215) 922-7112 - - -

1

- - -

2

I N D E X

3

- - -

4 WITNESS

5 PAUL A. NOEL, M.D.

6

7 EXAMINATION BY:

PAGE

8 MR. RUDOVSKY

5, 199

9 MS. YEH

172, 201

10 MR. MAZESKI

196

11

- - -

12

E X H I B I T S

13

- - -

14 NUMBER DESCRIPTION

PAGE

15 P-1

Resume

7

16 P-2

12/13/14 Letter

13

17 P-3

Inmate Request

13

18 P-4

Transcript

16

19 P-5

Contract

23

20 P-6

Contract

27

21 P-7

Printout

38

22 P-8

Emails

64

23 P-9

Roundtable Document 115

24 P-10 Doctor Dewsnup Guidelines 118

Page 2

Page 4

1 APPEARANCES:

2

KAIRYS, RUDOVSKY, MESSING & FEINBERG

BY: DAVID RUDOVSKY, ESQUIRE

3

The Cast Iron Building

718 Arch Street, Suite 501 South

4

Philadelphia, Pennsylvania 19106

Phone: (215) 925-4400

5

Representing the Plaintiffs

drudovsky@krlawphila.com

6

PENNSYLVANIA INSTITUTIONAL LAW PROJECT

7

BY: SU MING YEH, ESQUIRE

The Cast Iron Building

8

718 Arch Sthreet, Suite 304 South

Philadelphia, Pennsylvania 19106

9

Phone: (215) 925-2966

Representing the Plaintiffs

10

smyeh@pailp.org

11

PENNSYLVANIA DEPARTMENT OF CORRECTIONS

BY: VINCENT R. MAZESKI, ESQUIRE

12

1920 Technology Parkway

Mechanicsburg, Pennsylvania 17050

13

Phone: (717) 728-7763

Representing the Defendant, PA Department of

14

Corrections

vmazeski@pa.gov

15

WEBER, GALLAGHER, SIMPSON, STAPLETON, FIRES & NEWBY

16

BY: ADAM GOODMAN, ESQUIRE

2000 Market Street, Suite 1300

17

Philadelphia, Pennsylvania 19103

Phone: (215) 972-7900

18

Representing the Defendant, Correct Care Solutions

agoodman@wglaw.com

19

20

ALSO PRESENT: PHILLIP HARRINAVINE

21

22

23

24

1 EXHIBITS: (CONT'D)

2 NUMBER DESCRIPTION

PAGE

3 P-11 Protocol

120

4 P-12 Transcript

122

5 P-13 Tracking Sheet

126

6 P-14 Fiscal Year Amounts 167

7 P-15 Emails

178

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

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1 (Pages 1 to 4)

Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 3 of 53 Dr. Paul Noel

Page 5

1

- - -

2

PAUL A. NOEL, M.D., after having been

3 first duly sworn, was examined and testified as

4 follows:

5

- - -

6

THE COURT REPORTER: Any stipulations?

7

MR. RUDOVSKY: So we'll have him read

8 and sign the transcript when it's done.

9

MR. MAZESKI: Okay.

10

MR. RUDOVSKY: And otherwise, all

11 objections are preserved and I'll give you some

12 instructions at this point as well.

13

- - -

14

(It is hereby stipulated and agreed by

15 and between counsel for respective parties that

16 sealing, certification and filing are waived and that

17 all objections as to the form of questions be reserved

18 until the time of trial.)

19

- - -

20

EXAMINATION

21

- - -

22 BY MR. RUDOVSKY:

23 Q. Doctor Noel, I'm David Rudovsky. I represent

24 along with other Counsel the plaintiffs and the

Page 7

1 Q. All right.

2

And for how long have you had that

3 position?

4 A. Since January of 2014.

5 Q. And for how long have you been with the

6 Department of Corrections in any capacity?

7 A. Since January of 2014.

8 Q. Okay.

9

- - -

10

(Whereupon, P-1 was marked for

11 identification.)

12

- - -

13 BY MR. RUDOVSKY:

14 Q. Doctor Noel, I've given you what's been marked

15 as P-1. Can you identify that for the record?

16 A. My resume.

17 Q. All right.

18

And that indicates your medical

19 background since you became a doctor; is that correct?

20 A. Correct.

21 Q. Okay.

22

Did you have experience working with

23 any of the private providers in the Department of

24 Corrections in terms of medical care?

Page 6

1 plaintiff's class in this case regarding Hep C

2 treatment in the Department of Corrections.

3

Have you ever had your deposition taken

4 before?

5 A. Yes, I have.

6 Q. Okay, so you know the general rules.

7 A. I do.

8 Q. I'll be asking questions. If you don't

9 understand my question, please tell me, I'll reframe

10 it. If you respond to my question, I'll assume that

11 you understood both my question and your answer, all

12 right?

13 A. Okay.

14 Q. And of course, as you know, you have to

15 respond orally to all the questions.

16 A. Sure.

17 Q. Doctor Noel, what is your current position in

18 the Department of Corrections?

19 A. Chief of Clinical Services.

20 Q. And what does that role encompass?

21 A. Basically, oversight of all the medical care,

22 that is, from a clinical aspect, all the medical care

23 provided by the Department of Corrections to the

24 inmates under their custody.

Page 8

1 A. Yes.

2 Q. And which ones and for which periods of time?

3 A. Chronologically, going backwards.

4 Q. Okay.

5 A. Prior to becoming Chief of Clinical Services

6 for the DOC, I was the Pennsylvania State Medical

7 Director for various contractors from 2012 to '14 for

8 Wexford Health Sources. Prior to that from 2005 to

9 2012 for Prison Health Services which merged later and

10 became Corizon.

11 Q. All right.

12

With respect to the current medical

13 care construct in the DOC, the DOC as I understand

14 contracts with private providers; is that correct for

15 the provision of medical care?

16 A. Yes, that's correct.

17 Q. And is there one company that holds that

18 contract now?

19 A. For the medical services, yes.

20 Q. And what company is?

21 A. Correct Care Solutions.

22 Q. All right.

23 A. Referred to as CCS.

24 Q. Okay.

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Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 4 of 53 Dr. Paul Noel

Page 9

1

We're going to refer to that as CCS for

2 purpose of the deposition.

3

That's the only company that you

4 contract with at this point?

5 A. For medical services.

6 Q. Right, and in terms of the provision of

7 medical services, putting aside Hep C treatment for the

8 moment, for all other treatment that's provided by CCS

9 who develops the protocols, the regulations, the

10 procedures by which medical care is provided?

11 A. It's twofold. From a policy standpoint it's

12 done by the Department of Corrections. But when you

13 get into individualized clinical care such as the

14 ordering of medications or the treatment, specifically,

15 of a patient, for example, with diabetes that is left

16 to the medical contractor, CCS.

17 Q. All right.

18

So let me be a little more specific

19 there. Let's use diabetes as an example. Are you

20 saying that the Department of Corrections establishes

21 the protocols for treatment of diabetes as opposed to

22 CCS and that CCS only applies those protocols on

23 individual inmate by inmate basis?

24 A. When you use the term treatment we include

Page 11
1 chronic conditions and infectious diseases? 2 A. Yes. 3 Q. For which ones? 4 A. Off the top of my head the basics, 5 hypertension, diabetes, dyslipidemia, pulmonary 6 diseases which include asthma and COPD, seizure 7 disorder, HIV. 8 Q. Okay. 9 A. Off the top of my head that's the basic ones. 10 Q. In developing those protocols and treatment 11 modules do you follow community standards for medical 12 treatment, that is, standards that apply outside the 13 prison context? 14 A. So your definition of community standards is 15 outside the prison context? 16 Q. So when you develop these protocols and you 17 decide what kind of treatment the DOC is going to 18 provide or offer to inmates what are those protocols 19 based on, are they based on national standards for 20 treatment of that particular disease? 21 A. I'm not sure there are national standards for 22 the types of things that are in the policy. Again, 23 it's not involved with choosing medications. It's 24 involved with the system of them being followed on a

Page 10

1 that as an all encompassing treatment plan. So if

2 we're going to take diabetes as an example, diabetes is

3 identified as a chronic condition. So the DOC will set

4 up policies of how that is to be followed, the timeline

5 and who is to follow them and what laboratory values --

6 excuse me, what laboratory tests are to be ordered, the

7 timelines between seeing patients and those types of

8 things. When it gets down to whether or not how much

9 insulin someone is going to get and adjusting the

10 insulin and whether they use insulin or an oral

11 medication that's entirely left to the medical

12 contractor.

13 Q. And if we were talking about other chronic

14 conditions like cancer, I assume the treatment

15 provisions are up to the doctor in assessing the

16 condition of the patient and whether that patient might

17 need surgery or medication or some other type of

18 treatment?

19 A. Correct.

20 Q. Okay.

21

And we're going to get to it. I know

22 there's a written protocol with respect to Hep C, which

23 we will get to.

24

Do you have written protocols for other

Page 12
1 regular basis and laboratory values. And I don't 2 believe there are specific national standards that are 3 agreed upon by everybody for the stuff that is in our 4 policy. 5 Q. If I use the term community standards, is that 6 something that you look to in adopting and writing 7 protocols and treatment procedures? 8 A. If there were community standards for the 9 types of things in the policy I don't believe there 10 necessarily are. 11 Q. You don't think there are community standards 12 for all the chronic diseases that you have to deal with 13 in the prison system? 14 A. I don't believe there's a single set of 15 community standards. For example, if we're doing 16 diabetes, how often should a patient be seen. I think 17 you can go to different specialists and get different 18 answers. But we decided to sit down and we probably -19 I don't remember to be honest with you when these types 20 of things were set up exactly timeframes. But it had 21 to do with our experience and being able to follow them 22 on a regular basis those types of things. The 23 laboratory tests we order I don't believe there are any 24 specific set of community standards.

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Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 5 of 53 Dr. Paul Noel

Page 13

1

- - -

2

(Whereupon, P-2 and P-3 were marked for

3 identification.)

4

- - -

5 BY MR. RUDOVSKY:

6 Q. Doctor Noel, I've handed you both P-2 and P-3.

7 These were provided to us by your Counsel in discovery

8 in this case. With respect to P-2, as you can see, the

9 first page is a letter from the Plaintiff in this case,

10 Mr. Chimenti, to John Wetzel, Secretary of the DOC.

11 And the second page which I want to draw your attention

12 to is a letter from Christopher Oppman back to Mr.

13 Chimenti dated January 15th, 2015; do you see that?

14 A. Yes.

15 Q. Okay.

16

Who is Mr. Oppman?

17 A. At the time he was the Director of the Bureau

18 of Health Care Services.

19 Q. And what was his responsibility as the

20 Director of Health Care Services?

21 A. He has administrative authority over the

22 healthcare system.

23 Q. All right.

24

If you will -- the letter from

Page 15
1 community standards. 2 Q. Right, so I understand on an individual case 3 basis, you know, how often you see the client and the 4 patient and so on. But you don't disagree for a lot of 5 chronic diseases including Hep C there are national 6 standards and community standards and how persons ought 7 to be treated, what type of drugs, whether surgery is 8 required, those kinds of decisions, are you saying 9 there are not community standards for that? 10 A. I think it's debatable on different ones. You 11 can pick a certain organization and say they have a 12 standard. And you can have another organization and 13 have another standard. You can have a physician that 14 may want to do it differently and considered community 15 standards. 16 Q. If you look at P-3, please. That is a 17 document that was filed by David Maldonado who is also 18 a plaintiff in this case. And the second page if you 19 will look at, January 12th, 2015, a letter signed by 20 Christopher Oppman to Mr. Maldonado. A couple of 21 questions on that. Again, the second paragraph, the 22 first sentence states, the Pennsylvania Department of 23 Corrections provides medical services to inmates that 24 are consistent with community standards; is that

Page 14

1 Mr. Chimenti obviously deals with his treatment or what

2 he would say lack of treatment with respect to

3 Hepatitis C. The second paragraph in the response from

4 Mr. Oppman to Mr. Chimenti's letter does it state in

5 the first sentence the Pennsylvania Department of

6 Corrections provides medical service to inmates that

7 are consistent with community standards?

8 A. Yes, I see that.

9 Q. All right.

10

So that's my question, Mr. Oppman,

11 apparently believes that the DOC provides medical

12 services that are consistent with community standards.

13

How do you understand that term?

14 A. Well, it's a fairly broad term consistent with

15 I think when we're talking about the diabetes and

16 specifically in the example of the diabetes we have a

17 certain timeline and certain specific tests that have

18 to be ordered. My point was I don't necessarily think

19 there's a community standard that says that same

20 timeline, those same lab tests. I think in the

21 diabetes example consistent with out of this is such

22 that patients are seen on a regular basis, patients

23 have their laboratory values followed in some specific

24 manner. So that's what I would say by consistent with

Page 16

1 correct?

2 A. That's what it says, yes.

3 Q. Okay.

4

And in the first paragraph,

5 specifically, with respect to Hepatitis C treatment,

6 five lines down the sentence reads the DOC/EHCS which I

7 assume is the Bureau of Health Care Services is

8 reevaluating our treatment protocol for Hepatitis C

9 given the new guidance issued by the American

10 Association of Liver Diseases, AASLD and the Infectious

11 Diseases Society of America, IDSA. Was that true at

12 that time in January of 2015 that the DOC was, in fact,

13 reevaluating its treatment protocol given the guidance

14 issued by those organizations?

15 A. Yes.

16 Q. Okay.

17

- - -

18

(Whereupon, P-4 was marked for

19 identification.)

20

- - -

21 BY MR. RUDOVSKY:

22 Q. Okay.

23

Doctor Noel, I've handed you a part of

24 a transcript from proceedings in the Abu-Jamal case

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Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 6 of 53 Dr. Paul Noel

Page 17

Page 19

1 also involving Hep C treatment. And this is the

1 contract.

2 testimony of Doctor Cowan.

2 Q. Right.

3

Who is Doctor Cowan, please?

3 A. He was the Medical Director of Rikers Island.

4 A. Currently?

4 Q. At the time of his testimony in this case

5 Q. Yes.

5 which was just last year?

6 A. Doctor Cowen is the State Medical Director for

6

MR. MAZESKI: 2015.

7 the Pennsylvania contract employed by CCS.

7

MR. RUDOVSKY: 2015.

8 Q. Okay.

8 BY MR. RUDOVSKY:

9

And is he also, and we'll get to this

9 Q. Let me ask you this, how long has Doctor Cowan

10 later, on the Hepatitis C Treatment Committee in the

10 been with CCS?

11 DOC?

11 A. January, 2016 he became the State Medical

12 A. He was. He is not currently.

12 Director for CCS in the Pennsylvania contract.

13 Q. When did he leave that committee? I don't

13 Q. Okay.

14 need the exact date, but how recently?

14

And what was his position before then,

15 A. Months ago, a few months ago.

15 if you know?

16 Q. And let me ask you this, who is currently on

16 A. Medical Director, Rikers Island.

17 that committee?

17 Q. So if -- I'm going to refer you to his

18 A. Myself and the Infectious Control nurse,

18 testimony now. And again, I want to refer you to Page

19 Richard Wenhold.

19 32 of his testimony. He was called as an expert by the

20 Q. Just the two of you?

20 DOC in the Abu-Jamal litigation and was qualified as an

21 A. Correct.

21 expert. And at Page 32 when he was being asked about

22 Q. And in establishing that committee is that

22 the treatment guidelines in the DOC he was asked a

23 kind of ad hoc whose on it or does the protocol specify 23 question at Line 17. Could we agree -- would you agree

24 which people and which categories ought to be on that

24 that the same standard of care that is applicable to

Page 18

1 committee; do you understand my question?

2 A. The policy stipulates who is on it.

3 Q. And what does the policy say as to who should

4 be on it?

5 A. The Chief of Clinical Services, myself, the

6 State Medical Director for the contract, in this case,

7 CCS. The policy doesn't CCS. It says medical

8 contractor.

9 Q. Right.

10 A. And the Infectious Control nurse.

11 Q. So which position is vacant now?

12 A. The medical contractor State Medical Director.

13 Q. And are you in the process of trying to fill

14 that position?

15 A. Yes.

16 Q. But it has not been filled yet?

17 A. Correct.

18 Q. Okay.

19

And Doctor Cowan at the time of his

20 testimony and you also testified in the Abu-Jamal case

21 was on the treatment committee?

22 A. No.

23 Q. What was his position at the time?

24 A. He was not involved with the Pennsylvania

Page 20

1 the community at large should apply in a correctional

2 setting? Answer, yes.

3

Were you aware of that testimony before

4 today?

5 A. I mean, I was there for the Court hearings. I

6 don't remember the specific interaction.

7 Q. And then the next question was isn't it a fact

8 that the Center for Disease Control has -- with respect

9 to Hepatitis C -- has adopted the AASLD Guidelines for

10 treatment as the standard of care. He said I'm not

11 specifically aware of those.

12

And then on the next page, 33, is there

13 not testimony at Lines 16 through 23 indicating the

14 position of the Center for Disease Control if you look

15 at that?

16 A. Again, your specific question is?

17 Q. Is that accurate that the Center for Disease

18 Control had adopted those standards?

19 A. I don't know.

20 Q. Okay.

21

Do you disagree with the State's expert

22 in the Abu-Jamal case that community standards outside

23 the prison should control the provision of medical

24 services within the prison setting?

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Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 7 of 53 Dr. Paul Noel

Page 21
1 A. Not entirely, no, I do not agree with that 2 entirely. I believe that there are adaptations that 3 need to be taken into account when you're inside a 4 prison system. 5 Q. Let me just follow-up on that, if the 6 community standard for treating a certain type of 7 cancer was surgery and that was the adopted community 8 standard around the country. When you say that might 9 be modified in a prison setting why? 10 A. The keyword on your question is if. I don't 11 think that the term community standard if that's what 12 we're talking about is not a well-defined terminology 13 in medicine of what community standard is. That often 14 is in the eyes of the beholder. 15 Q. And I understand there could be disputes about 16 what standards apply for a particular treatment or 17 particular disease. But if there is an identified 18 community standard, all the medical organizations, all 19 the experts, say this is the treatment that should be 20 given, in that situation where there's not a dispute in 21 the outside medical community are you saying that 22 within the DOC there might be a different treatment 23 module that would be promulgated? 24 A. Yes.

Page 23

1 Q. Okay.

2

- - -

3

(Whereupon, P-5 was marked for

4 identification.)

5

- - -

6 BY MR. RUDOVSKY:

7 Q. I've handed you what's been marked as P-5.

8 Again, this was provided to us in discovery by your

9 Counsel in response to a request for the current

10 contract between the DOC and CCS. I'm going to have a

11 couple of different provisions, but I'm starting with

12 the document that's marked CCSK58-108.

13

MS. YEH: And just for the record's

14 purposes, it's labeled that, that's how it was produced

15 to us in discovery from Mr. Mazeski.

16

MR. RUDOVSKY: Right.

17 BY MR. RUDOVSKY:

18 Q. And if you would turn first to Page 5. The

19 first full paragraph, the last sentence, does it not

20 read that "CCS will ensure healthcare services are

21 delivered to State -- are delivered to State and

22 national standards including ACA State boards of

23 medicine regulations and a number of other provisions.

24

Is that what it states?

Page 22
1 Q. For what reason? 2 A. Inside the prison walls there are security 3 restrictions. There are limited number of staff, 4 limited number of resources, movement, going outside 5 for appointments. There are many variables in the 6 prison healthcare system that doesn't always directly 7 translate into what some people would call community 8 standards which I'm going to tell you right now is not 9 an agreed upon term. 10 Q. Again, following up my hypothetical, if the 11 community standard was that a certain disease should be 12 treated with a certain kind of drug and that's the only 13 drug that should be used, putting aside the 14 security issues, you know, where you give the drug to 15 the person and you take him out to a hospital, I 16 understand that. I'm talking about the treatment. Why 17 would that differ for an inmate who is in the DOC as 18 opposed to that person as a patient in the community? 19 A. The things you said put aside are not 20 inconsequential, first, I'd like to state that. Second 21 of all, if you're talking about a specific medicine for 22 a specific condition and that is the only medicine 23 available, if your question is would we modify that in 24 some way the answer would be no.

Page 24

1 A. Yes, it does.

2 Q. Okay.

3

If you will go to Page 12, third

4 paragraph before the bullet points, does it state PA

5 DOC seeks a company with financial stability and

6 demonstrated expertise in and then the bullet point

7 third from the bottom compliance with State and

8 national standards; does it state that?

9 A. Correct.

10 Q. And what does that mean?

11 A. I'm not sure.

12 Q. This is the contract between DOC and CCS and

13 you're not sure what that provision means?

14 A. Correct.

15 Q. Okay.

16

MR. GOODMAN: Objection, it doesn't --

17 I mean, what -- there's been no ground laid as far as

18 whether he was even involved in the contract signing at

19 all or whether he had any knowledge of it.

20

MR. RUDOVSKY: All right, let me

21 follow-up on that.

22 BY MR. RUDOVSKY:

23 Q. I believe when you described your position it

24 includes contracting with the current medical provider,

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Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 8 of 53 Dr. Paul Noel

Page 25

1 does it not?

2 A. Correct.

3 Q. You are the person who contracts with the

4 current medical provider?

5 A. Correct.

6 Q. Okay.

7

Page 15, the second full paragraph,

8 does it read the CCS program has been designed to

9 include elements that comply with the program

10 requirements identified by the PA DOC. This includes

11 providing: First bullet point, healthcare services at

12 a standard of care consistent with community standards

13 of care and all applicable Pennsylvania statutes and

14 laws; is that what it states?

15 A. Correct, and to answer your question that I

16 wasn't sure exactly what that meant because I didn't

17 have a chance to review this before coming in here and

18 you're throwing bullet points at me without me being

19 able to see the context of it all. If I can just take

20 a second to see where this is I can probably better

21 answer that question in the sense of they used the word

22 community standards and that is correct. And when we

23 develop policies and procedures we look at various

24 organizations of the outside for input. We do review

Page 27

1 the RFP, correct?

2 Q. That's right. And based on that response they

3 were given the contract; isn't that correct?

4 A. Not based on that single response. That was

5 part of their thousand page response.

6 Q. But you're the contract person?

7 A. Yes.

8 Q. You solicited requests for proposals, right?

9 A. Yes, correct.

10 Q. You got one from CCS that included everything

11 I've just read to you, right?

12 A. Correct.

13 Q. And based on that and obviously other reasons

14 you have signed a contract with CCS?

15 A. Correct.

16

- - -

17

(Whereupon, P-6 was marked for

18 identification.)

19

- - -

20 BY MR. RUDOVSKY:

21 Q. So this is another document provided in

22 discovery, again, with the numbers on top so we know

23 what it is CCSK108-157.

24

And first at Page 50 of that document

Page 26

1 those type of things. We also look which is more

2 consistent with what we do is what prison system

3 organizations which is part of our community. That's

4 actually our community is the prison system. And we

5 look at the so-called outside community and we look at

6 those things and they're all part of our decision

7 making process in what we do with policies and

8 procedures. But I'm going to go back again that you

9 use the word community standards such that there is a

10 piece of paper somewhere that has a list of all these

11 things that are very specific and only apply in certain

12 conditions and there just is not such a community

13 standard.

14 Q. If you turn to Page 24, last 2 lines, again,

15 CCS correct care. "We are prepared to continue

16 providing medical services that meet the same good and

17 acceptable medical standards provided to members of the

18 public to the extent practicable given the inmates

19 confinement status and in compliance with DOC and CCS

20 policies and procedures.

21

Have I read it correctly?

22 A. Yes.

23 Q. Okay.

24 A. If I may just -- this is the CCS response to

Page 28

1 just a question, there's a section entitled Centers of

2 Excellence and the first bullet point refers to

3 Hepatitis C Centers of Excellence, SCI Dallas and SCI

4 Muncy. Do you know what's being referenced there?

5 A. Yes, that was the previous treatment regimens

6 that included injections with Inteferon. At that time

7 we were sending all the patients for that course of

8 treatment to those two centers. We no longer do that.

9 Q. Okay.

10

Then Page 73, last page of the

11 document. The section that starts the following table,

12 about a third of the way down, is provided as examples

13 of national guidelines upon which CCS relies when

14 formulating its own working guidelines. As to

15 Hepatitis C it refers to the American Association for

16 the study of Liver Diseases; do you see that?

17 A. I do see that.

18 Q. Okay.

19

And that's the only organization listed

20 in that particular section; is that right?

21 A. Under guidelines.

22 Q. Right, okay.

23

Doctor Noel, in your view if you could

24 identify the leading national medical organizations or

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Page 29

1 groups that have expertise with respect to Hepatitis C

2 treatment, that is, who would you look to for guidance,

3 assistance in formulating Hep C policy in the prison

4 among national medical organizations?

5 A. Federal Bureau of Prisons would be number one,

6 AASLD. And we would also look to -- we also look at --

7 well, we looked at lots of them in the sense of what we

8 looked at. Those are the two prominent ones. The one

9 that we talked about AASLD, but what we haven't talked

10 about is the Federal Bureau of Prisons National

11 Organization that is an expert in this, but...

12 Q. We'll get to that.

13 A. Okay.

14 Q. What about the Infectious Disease Society of

15 America?

16 A. Yes.

17 Q. All right.

18

Have you heard of an organization

19 called the National Viral Hepatitis C Roundtable?

20 A. I have not.

21 Q. Okay.

22

Have you done any studies of your own,

23 studies, research, trials with respect to Hep C

24 treatment?

Page 31

1 and so on based on the testimony I read and so on. And

2 let me ask you this, is it correct that Hepatitis C is

3 a blood-borne infection?

4 A. Just let me preface that I'm not an expert in

5 Hepatitis C. I'm not a hepatologist nor a

6 gastroenterologist. My main participation in this was

7 putting together a policy. But with that being said, I

8 would be happy to answer some questions.

9 Q. Okay, and obviously to the limits of your

10 knowledge, I understand that.

11

Are you familiar with the Metavir

12 fibrosis score?

13 A. I am.

14 Q. Okay.

15

And could you explain for the record

16 what that refers to?

17 A. It's a score that reflects progression of

18 liver disease as identified looking at a slide of

19 pathological specimen of the liver. So a pathologist

20 looks at the slide and there are some technical

21 differences of which I am not specialized to explain

22 that shows the progression of liver disease from no

23 affect on the liver, in essence a normal liver, through

24 a progression to the end stage of cirrhosis. And the

Page 30

Page 32

1 A. We track data, but I don't have any research

1 scores are F0 being there is a normal liver through F4

2 studies, no.

2 which is cirrhosis. And 1, 2 and 3 are progressive

3 Q. Okay.

3 changes that are seen on slide that indicate a

4

Have you read any of the peer reviewed

4 progression of the liver disease.

5 literature with respect to the new direct acting

5 Q. And the F1 to F3 commonly referred to as

6 antiviral drugs?

6 fibrosis; is that correct?

7 A. Yes.

7 A. Yes.

8 Q. Okay.

8 Q. And when it gets to F4 that becomes a more

9

Can you list -- and again, I'm just

9 serious condition that's known as cirrhosis?

10 testing your memory, but what periodicals or documents

10 A. Correct.

11 or peer reviewed articles if you can identify at this

11 Q. Okay.

12 point that you consulted in the last couple of years?

12

And is it fair to say from what you've

13 A. Generally speaking, the main sources of peered

13 read and reviewed that approximately 75 to 85 percent

14 medical literature are the Journal of the American

14 of persons who are initially infected with Hepatitis C

15 Medical Association referred to as JAMA. And the New 15 will eventually have what we call chronic Hep C which

16 England Journal of Medicine which is referred to as

16 brings us into the F0 to F4 range?

17 NEJM. Are ones that are the most widely referenced in

17 A. Correct.

18 general medicine in the United States.

18 Q. Okay.

19 Q. Do you know any that are specific to Hepatitis

19

Is it fair to say also that among that

20 C care and treatment?

20 group approximately 40 percent will at some point

21 A. I don't remember any articles, no.

21 progress to cirrhosis?

22 Q. Okay.

22 A. I'm not sure of that percentage off the top of

23

Doctor Noel, I just want to get some

23 my head.

24 basic information down about Hepatitis C, what it is

24 Q. Okay.

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Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 10 of 53 Dr. Paul Noel

Page 33

1

And is it also fair to say that among

2 that group that progresses to cirrhosis about five

3 percent will contract liver cancer?

4 A. I've seen that data. That's consistent with

5 what I've seen.

6 Q. And that some 3 to 5 percent will die from

7 that condition?

8 A. Correct.

9 Q. And in fact, have you seen data that indicates

10 that about 19 to 20,000 people in the United States die

11 of Hepatitis C each year?

12 A. I do not know that data.

13 Q. Okay.

14

And other data that shows it is the

15 most deadly infectious disease in the United States?

16 A. I'm not sure what most deadly means.

17 Q. Okay, that's fair.

18

More people die from Hepatitis C than

19 any other infectious disease in the United States, have

20 you seen any reference to that?

21 A. Yes.

22 Q. Okay.

23

Do you know anything about -- we've

24 talked about progression and you've talked about this

Page 35

1 possibility based on what you've read?

2 A. I don't believe I've seen anything that said

3 cirrhosis in 10 years. But it's very difficult because

4 you don't always know when times 0 was.

5 Q. Okay.

6

What do you know about the

7 manifestations of Hepatitis C with respect to the

8 various F stages, that is, what kind of disease has

9 been seen in people with Hepatitis C if you can give me

10 everything you know about the types of conditions,

11 diseases, pain, suffering that someone will suffer from

12 when they have Hepatitis C?

13 A. Well, most often we talk about -- well, I'll

14 work backwards from cirrhosis. Cirrhosis being the end

15 stage of liver disease. At that time you can become

16 jaundice. You accumulate a lot of fluid which is

17 referred to as ascites. You have a large belly. You

18 may have encephalopathic changes which means mental

19 status changes. There might be pain just because of

20 the size of the ascites pushing your belly out. There

21 could be bleeding of the esophageal varices. These are

22 the most significant symptoms and signs. And

23 obviously, significant changes in blood work that are

24 consistent with those kinds of things with the

Page 34

1 F0 to F4 and I've sketched out just some of the

2 percentages here. Do you know anything about the rate

3 of progression for any particular individual or do we

4 know anything about that, how quickly one might go from

5 F1 to F2 to F3, for example. How quickly you might get

6 to cirrhosis and how many people actually will get

7 there?

8

MR. GOODMAN: Objection, it's a

9 compound question.

10

MR. RUDOVSKY: Let's see if he can

11 answer it.

12

THE WITNESS: I've seen different

13 numbers. But in general, it's fair to say that the

14 progression of disease -- just we'll call it the

15 natural progression of the disease is that it takes

16 decades and you can see someone that will say 20 years

17 and some will say 40 years. But it's fair to say it

18 takes decades to progress to cirrhosis.

19 BY MR. RUDOVSKY:

20 Q. Are there situations that you've seen where

21 somebody has progressed to cirrhosis within 10 years?

22 A. I have not personally -- I have no data to

23 support that.

24 Q. But you don't dispute that that's a

Page 36
1 cirrhosis. 2 Q. Would you also at that stage see cancer? 3 A. Yes. 4 Q. Would you see renal failure? 5 A. Could be end stage, yes. 6 Q. Diabetes? 7 A. That's a little more nebulous the correlation 8 between diabetes and cirrhosis. And I would defer to a 9 specialist on tying those two together. 10 Q. And the reason I ask that I've seen references 11 to hepatic disease which we're talking about the liver, 12 right? 13 A. Yes. 14 Q. And then also references to extra hepatic 15 conditions -16 A. Yes. 17 Q. -- and nonhepatic conditions. Can you explain 18 in your view what do you understand those differences 19 to be? 20 A. Again, I have not dealt personally with these 21 kinds of cases. These are very rare cases. And just 22 as an aside, everyone of these cases gets referred to a 23 hepatologist because they fall outside the normal 24 protocol. And there are things like long names,

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Page 37

Page 39

1 cryoglobulinemia, cutanea tarda. These are long Latin

1 IDSA their guidelines for Hepatitis C.

2 medical terms that have to do with other type of

2 Q. Right, again, we have copies that were also

3 rheumatologic diseases where specialists have found

3 provided by your Counsel. Are you familiar with this

4 that there appears to be some correlation in the

4 document?

5 disease that is not liver related for those who have

5 A. I am.

6 Hepatitis C.

6 Q. Okay.

7 Q. And what is your understanding as to whether

7 A. Let me correct that.

8 some of the symptoms we've been talking about that you

8 Q. Yes.

9 just described can appear earlier or later, that is, if

9 A. I'm not necessarily familiar with this

10 you're at F2 isn't it possible you'll have a number of

10 particular document in front of me. I'm familiar with

11 the conditions you just described even though you're

11 the website and the fact that they put out this type of

12 only at F2 as opposed to F4? And conversely, you might 12 information.

13 be at F4 and suffer less of those consequences?

13 Q. Just to be specific, this was the -- while it

14 A. Unlikely on having an F2 with those advanced

14 was pulled out of the website more recently. It was

15 and I would defer to a specialist on that. But I have

15 from their October, 2016 their latest update --

16 not personally ever seen anyone with F2 that had

16 A. Yes.

17 ascites and esophogeal varices. By definition those

17 Q. -- as to their recommendations, okay?

18 are consistent with cirrhosis which is an F4.

18 A. Okay.

19 Q. I'm not asking any specific one. What I'm

19 Q. Are you familiar with the October the full

20 asking about is is this kind of linear, that is, simply

20 2016 update?

21 because you're at F2 means you're only going to suffer

21 A. I'm familiar with it, yes.

22 from certain conditions and F4 it's going to be much

22 Q. Okay.

23 worse or doesn't the literature sure that, in fact,

23

Have you read that update before today?

24 it's not linear and it's not a strict concordance

24 A. I don't remember exactly what I read from it

Page 38

1 between your F stage and the manifestations you may be

2 suffering from?

3 A. My understanding is that that might hold true

4 as you get closer and closer to cirrhosis. You can

5 make a case maybe that there are patients that might be

6 at F3 and show some of the manifestations of late

7 disease. But I've never seen anything myself

8 personally that I know of when you start getting into

9 F1 and 2 that show those signs and symptoms of advanced

10 cirrhosis. I've never seen that correlation.

11 Q. So let's stick with that 3 for a moment. Is

12 it not true that at F3 there are recommendations from

13 the National Medical Association's concern with

14 Hepatitis C that those persons be monitored for cancer

15 on a regular basis?

16 A. I have not seen that.

17

- - -

18

(Whereupon, P-7 was marked for

19 identification.)

20

- - -

21 BY MR. RUDOVSKY:

22 Q. I've given you what's been marked as P-7. Can

23 you identify that, please?

24 A. It's the website printout from the AASLD and

Page 40

1 to be honest with you.

2 Q. Okay.

3

Let me just at this point -- we're

4 going to go through it in a little more detail. But on

5 the question I asked you about screening and

6 surveillance and monitoring for liver cancer even

7 before F4 if you turn to Page 10. You know what,

8 they're not marked, I'm sorry. That's the problem with

9 this document. It's 3 pages from the last -- from the

10 end. I marked mine 10, but I didn't mark yours. Okay,

11 you got it.

12

Right below the box, I want to call

13 your attention to the paragraph that reads an accurate

14 assessment of fibrosis remains vital, as degree of

15 hepatic fibrosis is one of the most robust prognostic

16 factors used to predict HCV disease progression and

17 clinical outcomes. (Everhart, 2010).

18

Individuals with severe fibrosis

19 require surveillance monitoring for liver cancer. Now,

20 severe fibrosis could be F3; is that correct?

21 A. Yes.

22 Q. And so they are now stating, this organization

23 is stating that at F3 you should be monitored for liver

24 cancer; is that correct?

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Page 41

1 A. That's what that statement says.

2 Q. Do you agree with that?

3 A. I have no -- that's for a hepatologist to

4 decide what -- how that translates into current

5 policies.

6 Q. Does your protocol deal with that issue?

7 A. Our protocol begins the surveillance for liver

8 cancer with the diagnosis of cirrhosis.

9 Q. Okay, we'll come back to the protocol and

10 we'll do that later.

11

I want to now, Doctor Noel, ask you

12 questions about these direct acting antivirals. I'm

13 going to refer to them as DAA, all right?

14 A. Okay.

15 Q. Starting in about 2011 is it true that the

16 FDAA since that time has approved for treatment for

17 Hepatitis C DAA drugs?

18 A. I don't know the exact timeline. That seems a

19 little early. If you have documentation that shows --

20 Q. I have a reference to 2011 they talked about

21 breakthrough drugs. But whether it was 2011 or 2012

22 are we talking about the right timeframe?

23 A. Approximately.

24 Q. The year doesn't matter. And does that

Page 43

1 Q. Okay.

2

And how about with Sovaldi?

3 A. Less experience with that personally, but the

4 literature seems in that same ballpark of greater than

5 90 percent.

6 Q. And any studies to date or reports to date of

7 any serious side effects from these drugs?

8 A. From the drugs by themselves?

9 Q. Yes, that's the question.

10 A. No, just with the caveat that treatment

11 regimen includes other drugs.

12 Q. I understand that depending on the condition

13 of the patient there may be other drugs. But with

14 respect to these what the FDA call breakthrough

15 drugs -- and do you know what that term means when the

16 FDA uses the term breakthrough drugs, what's the

17 significance of that?

18 A. The significance is the cure rate. When we

19 used the drugs before which were Interferon based I

20 don't have the exact statistics but it was on the

21 magnitude of 50 percent cure rate. So from when you go

22 from 50 or 60 percent cure rate to 90 percent cure rate

23 in a short period of time that's where the term

24 breakthrough came, I believe.

Page 42

1 include drugs like Harvoni, Sovaldi, Zepatier,

2 Z-E-P-A-T-I-E-R and Epclusa, E-P-C-L-U-S-A?

3 A. It includes those if you understand that they

4 were chronologically added through the years. And they

5 were not all at the beginning whatever the beginning is

6 which was after 2011.

7 Q. Right, and do you remember which was the first

8 drug in that progression?

9 A. Sovaldi.

10 Q. Okay.

11

And Harvoni came soon thereafter; is

12 that correct?

13 A. A year later about.

14 Q. Okay.

15

And is it your understanding and let's

16 stick with Harvoni, for example, that that has a very,

17 very high cure rate for Hepatitis C?

18 A. What's a very high cure rate?

19 Q. Over 90 percent?

20 A. Correct.

21 Q. I've seen references to 95 percent; is that

22 correct?

23 A. We're not seeing 95 percent. We're seeing 90

24 percent.

Page 44

1 Q. Okay, all right.

2

So we've now had whether it's 2011,

3 2012 about four years of experience with these drugs;

4 is that correct?

5 A. Yes.

6 Q. Okay.

7

Now, and I want to refer you back to

8 this document which is P-7 which is the as I say the

9 October, 2016 iteration from AASLD and IDSA with

10 respect to their recommendations for testing, managing

11 and treating Hepatitis C. And as you said before this

12 is a document that has its own progression; is that

13 right, that they've been putting out their

14 recommendations for a number of years now?

15 A. Yes.

16 Q. As to -- with specific reference to the DAA's;

17 is that correct?

18 A. Correct.

19 Q. Okay.

20

Let me ask you this, what was the last

21 version that you actually read whether it was in

22 October or June or even earlier this year, but within

23 the last year, I assume you referred to this because

24 your own protocol refers to it and we have some emails

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Page 45
1 where you say you reference AASLD in developing your 2 protocol. So without reference to this particular 3 document although I don't think it's changed very much. 4 In the past year have you actually had the opportunity 5 to look at their recommendations? 6 A. Yes. 7 Q. So let me ask you a general question first and 8 then I'll get specific if I have to. Was there 9 anything in these recommendations and this is a 11 -10 12 page document, that you have looked at in the last 11 year that you had a disagreement with respect to the 12 treatment recommendations and the reasons that they 13 give for those treatment modules? 14 A. I don't have the whole -- and again, this is 15 not the whole document. This is a very small part of 16 the entire document on a website that it's hundreds of 17 pages long. 18 Q. Well, that include my question to be 19 everything that you've read, whether it's this document 20 or the hundreds of pages of backup information, my 21 question still is can you recall over the last year, 22 year and a half, 2 years in reviewing their 23 recommendations, their data, their studies, their peer 24 reviewed articles, anything specifically that you

Page 47

1 treating HCV by other therapies; is that correct?

2 A. That's what it says.

3 Q. And that reflects what you just said their

4 recommendation is everybody from F0 to F4 any chronic

5 Hepatitis C should be treated with the DAA?

6 A. Correct.

7 Q. Okay.

8

Page 2, there are 2 boxes there. They

9 talk about the goal of treatment and recommendations

10 for when and in whom to initiate treatment which

11 basically reflects what you just read. And they have

12 ratings, Class 1, Level A on both of those goals and

13 recommendations. Do you know what those ratings refer

14 to?

15 A. In general, the strength of the scientific

16 evidenced based literature that they used in coming up

17 with that recommendation.

18 Q. And is it fair to say Class 1, Level A is the

19 highest level of surety?

20 A. I have no knowledge of that.

21 Q. Okay.

22

Continuing on that page, under clinical

23 benefit of cure, the second paragraph. Patients who

24 are cured of their HCV infection experience numerous

Page 46

Page 48

1 disagree with either with respect to their

1 health benefits including a decrease in liver

2 recommendations or as to why they were making those

2 inflammation; do you see that?

3 recommendations?

3 A. I see that, yes.

4 A. I can't cite the specific, but in general, the

4 Q. Do you agree with that?

5 flavor and I don't have -- I'm not prepared to discuss

5 A. Yes.

6 it because I don't have it in front of me, that the

6 Q. Okay.

7 AASLD comes out more on the side of treating viremia

7

The last sentence in that paragraph,

8 which means everybody who is positive without

8 among HCV infected persons, SVR which is the sustained

9 acknowledging very well the need to prioritize and

9 viral response, right?

10 treat the sickest ones first. They do have at times

10 A. Correct.

11 some language in there and we'll provide that later.

11 Q. Is associated with a more than 70 percent

12 But for most people who read this they come away with

12 reduction in the risk of liver cancer which I'll later

13 the message that AASLD recommends that everybody be 13 call HCC and a 90 percent reduction in the risk of

14 treated without acknowledging a prioritization. That

14 liver related mortality and liver transplantation; do

15 is the thing we have the most difficulty with in

15 you agree with that?

16 actually trying to operationalize something in a real

16 A. I don't have enough scientific knowledge to

17 world scenario inside a closed prison system.

17 disagree with that. When I read that I had no thoughts

18 Q. So let me take you through this just at some

18 on whether that was right or wrong. I take it at face

19 specific sections. I understand your position. I'll

19 value. I have nothing to the contrary.

20 come back to this prioritization in a moment, okay.

20 Q. Right, that's my question, do you know of any

21

Page 1, first paragraph, last sentence,

21 study or any expert who has opined to the contrary on

22 the panel continues to recommend treatment for all

22 that?

23 patients with chronic HCV infection except those with

23 A. No.

24 short life expectancies that cannot be remediated by

24 Q. Okay.

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Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 14 of 53 Dr. Paul Noel

Page 49

1

Next paragraph, cure of HCV infection

2 also reduces symptoms and mortality from severe

3 extrahepatic manifestations and then they list a number

4 of those. Any disagreement with that?

5 A. No.

6 Q. Okay.

7

Next page, please. Bottom of that

8 first and complete paragraph does it read because of

9 the many benefits associated with successful HCV

10 treatment, clinicians should treat HCV infected

11 patients with antiviral therapy with a goal of

12 achieving an SVR preferably early in the course of

13 chronic HCV infection before the development of severe

14 liver disease and other complications; do you agree

15 with that?

16 A. I agree with that with the same caveat

17 regarding prioritization.

18 Q. Okay, we'll come back to the prioritization.

19 But otherwise, you don't disagree with that statement?

20 A. I do not disagree with that statement.

21 Q. There's several paragraphs that deal with the

22 benefits of treatment at the early fibrosis stages

23 which they say is below F2. So we're talking about F0

24 to F1. And they start off by saying initiating therapy

Page 51

1 timeframe; any disagreement with that proposition?

2 A. I have no knowledge to the contrary, no.

3 Q. Okay.

4

Next paragraph, numerous studies have

5 demonstrated that Hepatitis C therapy and the

6 achievement of an SVR in this population results in

7 dramatic decreases in hepatic decompensation events,

8 HCC and liver related mortality; any information to the

9 contrary?

10 A. No, I do not.

11 Q. Page 5, paragraph headed persons at greater

12 risk for rapidly progressive fibrosis and cirrhosis.

13 Fibrosis progression is variable across different

14 patient populations as well as within the same

15 individual over time. Many of the components that

16 determine fibrosis progression and development of

17 cirrhosis in an individual are unknown.

18

Do you agree with that or do you know

19 of anything to the contrary?

20 A. I know nothing of the contrary.

21 Q. And let me ask you this, your current

22 population at the DOC who have been diagnosed with

23 chronic Hep C do you have a number, an estimate that

24 you can give me on that?

Page 50

1 in patients with lower stage fibrosis augments the

2 benefits of SVR. And then they refer to a number of

3 studies that were done referring to Jezequel, 2015 and

4 another study Ovrehus, 2015 and another study by Zahnd,

5 2015 which all stand for the proposition that

6 initiating therapy early augments the benefits of SVR.

7

Two questions, do you agree with that

8 and/or do you have any scientific information by

9 experts or organizations that take a different view?

10 A. I have no knowledge of anyone taking a

11 different view.

12 Q. Okay.

13

And there's also reference there to the

14 U.S. Veteran's Administration data said also reflecting

15 that same result; do you see that final paragraph?

16 A. Yes, I have. I'm reading it. And I have no

17 information to the contrary.

18 Q. Okay, all right.

19

Next page, 4, first paragraph. For

20 person's with advanced liver disease (Metavir stage F3

21 or F4), the risk of developing complications of liver

22 disease such as hepatic decompensation -- I'm going to

23 skip some of the stuff in parenthesis. Or HCC is

24 substantial and may occur in a relatively short

Page 52

1 A. Approximately, 5,500.

2 Q. Okay.

3

So thinking about what I just read, if

4 this is accurate it would be very difficult to know

5 among that 5,500 which inmates are going to progress

6 quickly, which inmates are going to progress less

7 quickly, which inmates are going to suffer what types

8 of manifestations at different stages of the disease;

9 is that accurate? If you're just looking at the 5,500

10 and you don't know anything else?

11 A. That's too broad brushed.

12 Q. All right, how would you limit it?

13 A. I don't have specific -- I'll give you some

14 outlier kinds of things to just paint a picture of what

15 I'm trying to guard against. And that was to be

16 someone said today you're at F0 and next year you can

17 have cirrhosis, you just don't see that, that just

18 doesn't happen.

19 Q. Right, I understand that.

20 A. You're trying to make that kind of -- it's not

21 correct.

22

Now, if you have five people at F3 how

23 long is it going to take those five to get to F4,

24 that's a variable.

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Page 53

1 Q. And that's fair. That's all I'm asking.

2

And by the same token, take people at

3 F2 or F3 is it possible that someone who is really at

4 F3 has suffered fewer manifestations in terms of pain

5 or discomfort or fatigue or other objective factors

6 than someone who is at F2?

7 A. Actually, those are subjective, not objective.

8 Pain and suffering and fatigue are subjective.

9 Objective findings such as lab tests correlate a little

10 better but still not completely.

11 Q. Okay.

12

The next page, Page 6, there's a

13 paragraph that talks about nonhepatic manifestations

14 and that references the diabetes which you've already

15 talked about; is that correct?

16 A. Yes.

17

I'm sorry, what's the questions?

18 Q. Yeah, so this document notes that there's a

19 relationship between chronic Hepatitis C and diabetes;

20 is that correct?

21 A. That's what it says.

22 Q. Okay.

23

And do you have any disagreement with

24 that?

Page 55

1 symptom and has a major affect on quality of life and

2 activity level evidenced by numerous measures of

3 impaired quality of life, pointing to a study by Foster

4 in 1998.

5

Any disagreement with that statement?

6 A. I haven't seen it personally in our population

7 to the level of these superlatives major affect, but it

8 is a factor, yes.

9 Q. And the next sentence reads, the presence and

10 severity of fatigue appears to correlate poorly with

11 disease activity, although it may be more common and

12 severe in HCV infected individuals with cirrhosis, a

13 study by Poynard, 2002; do you agree with that?

14 A. Yes, I agree with that more than the first

15 one. It sounds like everybody was tired. Yes, I agree

16 with that second one.

17 Q. Okay.

18

There's then a reference to a study by

19 Bonkovsky, 2007 and Sarkar, 2012 which indicate a

20 reduction in fatigue after a cure of HCV infection.

21 Any reason to dispute that statement or those studies?

22 A. No.

23 Q. Bottom of the page, benefit of treatment to

24 reduce transmission. Persons who have successfully

Page 54

1 A. I do not.

2 Q. Okay.

3

Next page and this gets me back to the

4 issue we just talked about. First, continuing on

5 diabetes, the second line, therefore, antiviral therapy

6 may prevent progression to diabetes in patients -- with

7 prediabetes who have Hepatitis C; do you agree with

8 that?

9

MR. GOODMAN: I'm sorry what paragraph

10 is that?

11

MR. RUDOVSKY: I'm sorry, the top

12 paragraph, the next page, just the end of that

13 paragraph.

14

THE WITNESS: Yeah, I have no knowledge

15 of the relationship between prediabetes and Hepatitis

16 C.

17 BY MR. RUDOVSKY:

18 Q. How about the rest of the sentence, and may

19 reduce renal and cardiovascular complications in

20 patients with established diabetes or have Hepatis C,

21 again, no knowledge?

22 A. No knowledge.

23 Q. Next paragraph, in patients with chronic

24 Hepatitis C, fatigue is the most frequently reported

Page 56

1 achieved an SVR no longer transmit the virus to others.

2 As such, successful treatment of HCV infection benefits

3 public health; any disagreement with that?

4 A. No, that's a true statement.

5 Q. Right, and in the prison setting that would be

6 true as well, it is true that there are incidents in

7 the prison where blood can be transferred from one

8 person to another either by sex or some other means,

9 would it also mean you can reduce the transmission in

10 the prison system if fewer people have HCV?

11 A. Yes.

12 Q. Okay.

13

Going to the third page from the end

14 now, let's skip a couple of pages. There's a section

15 entitled populations unlikely to benefit from HCV

16 treatment. And part of that reads little evidence

17 exists to support initiation of HCV treatment in

18 patients with limited life expectancy (less than 12

19 months) owing to nonliver related comorbid conditions;

20 do you agree with that?

21 A. I do.

22 Q. Okay.

23

Turn to the next page where it says

24 fibrosis progression varies markedly between

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Page 57

1 individuals based on host, environmental and viral

2 factors; do you agree with that?

3 A. I do.

4 Q. It then states fibrosis may not progress

5 linearly; is that correct as well?

6 A. Yes.

7 Q. And then a little further down, the presence

8 of existing fibrosis is a strong risk factor for future

9 fibrosis progression?

10 A. Agreed.

11 Q. Okay, all right.

12

Now, you qualified your answer in part

13 by saying while you might agree with everything that we

14 just read and it looks like you agreed with most of it,

15 there's no recommendation here for prioritization; is

16 that right?

17 A. Correct.

18 Q. Okay.

19

And in fact, you mentioned early on and

20 my reference to 2014 and so on when the drugs were

21 first coming into the market there was some

22 prioritization recommended because there weren't enough

23 drugs available for everybody to use. So I could

24 understand you had to prioritize if you had a thousand

Page 59
1 putting aside cost, putting aside cost and now we've 2 been in this for several years. So tell me even 3 starting today, how long would it take to treat the 4 5,500 or whatever that number might be in the system? 5 A. And that's an important point that you brought 6 up because we didn't know at the beginning of this. 7 Q. But now I'm assuming the hypothetical is we're 8 here today, the drugs are inexpensive, that's not a 9 problem for the DOC. How long would it take you to 10 treat that population? 11 A. Our best estimate currently which is -- can be 12 revised as we go along going forward, is that we can 13 treat between 400 and 450 a year based on operational, 14 security, logistical issues. 15 Q. And that's putting aside the cost factor? 16 A. Absolutely. 17 Q. So if these drugs were free the most you can 18 treat is 400 or 450 a year? 19 A. Correct. 20 Q. So when you talk about priority you then say 21 -- I don't want to put words in your mouth but I think 22 what I understand is we'll treat the sickest first? 23 A. Correct. 24 Q. Okay.

Page 58

1 possible patients but you only had drugs for a hundred

2 then you would prioritize in what way?

3 A. That was never a case with us. I'm not

4 familiar with that scenario.

5 Q. So your prioritization was not based on your

6 inability that the manufactures didn't have this drug?

7 A. Correct.

8 Q. Okay.

9

And there's the elephant in the room,

10 we all know what we're talking about here, right. The

11 prioritization you're talking about is funding; is that

12 correct?

13 A. Not totally.

14 Q. Well, so let's start this way, aside from

15 funding and let me give you the hard hypothetical. If

16 these drugs cost $10 for the 8 weeks or 12 weeks that

17 you have to do it for every inmate, right, would you

18 not follow what AASLD recommends and treat everybody

19 from F0 to F4?

20 A. I could not. It's physically impossible.

21 Q. I'm sorry?

22 A. Logistically, operationally and security wise

23 it would be impossible to treat them all right now.

24 Q. And how many could you treat now, again,

Page 60

1

So you try to identify the 400, 450 who

2 are the sickest, start with that group and then work

3 your way down?

4 A. Correct.

5 Q. Okay.

6

And would that be true if it was a

7 different kind of disease like cancer or diabetes or

8 all of a sudden there's a cure for that particular

9 disease that because you're a prison system you only

10 would be able to treat in the first year 10 percent of

11 the people with that condition?

12 A. I'm not following your -- you're really going

13 on a hypothetical here so could you rephrase that a

14 little better.

15 Q. Well, the 10 percent is based on your saying

16 400, 450. It's actually less than 10 percent because

17 you got 5,500 inmates with Hep C. So what you're

18 saying is in that first year the best you can do is

19 somewhere between 7 and 9 percent it sounds like of

20 that population. And I'm asking whether that would be

21 true if we transfer this to a different situation, we

22 now have a cure for diabetes, some magic cure comes

23 through or a cure for a particular type of cancer which

24 some inmates may have and it's a large number, right;

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Page 61
1 would you also have those security limitations? 2 A. It's not fair to use the cancer one because 3 it's such a small number compared to this. If we had 4 another -- let's just take the diabetes if that's where 5 you want to go with this. And there's a cure for 6 diabetes and we had many thousands, which we do, 7 diabetics. And the same medical resources were needed 8 then yes, we couldn't do it all. We can only do so 9 much. 10 Q. But when you say you can only do so much isn't 11 that also a money factor. When you say, for example, 12 we can only treat 450 people is that because -- I 13 understand your term security, but if you hired more 14 correctional officers, if you hired more medical 15 people, if you had more contracts with outside agencies 16 to get the drugs, whatever you would have to do, we had 17 a huge emergency, you had all the money that was 18 available to you, you still can only do 400 to 450 19 people a year? 20 A. I wouldn't even know how to answer that. The 21 conversations have also been around the cost of the 22 medication. If you're taking this to another level 23 where I start building prisons to put people into or I 24 start letting them -- if you go bizarre scenarios like

Page 63

1 are you paying now your best recollection at this point

2 or your best estimate per treatment per inmate what

3 you're paying for the DAA's? I know the price has come

4 down, but I don't know how much its come down.

5 A. I don't have an exact dollar in front of me.

6 It's approximately -- give me a second.

7 Q. Sure.

8 A. It's approximately $50,000 for a 12 week

9 course.

10 Q. Okay.

11

And so based on your answer you have a

12 budget for the coming year that would allow you to

13 treat up to 450 inmates at $50,000 an inmate?

14 A. First of all, the ground rules on the term

15 year.

16 Q. Okay.

17 A. There's calendar year and there's fiscal year.

18 So it's important that we deal in fiscal years.

19 Q. Okay.

20 A. So fiscal year '16-'17.

21 Q. Which covers what period?

22 A. July of 2016.

23 Q. Right.

24 A. To June of 2017. That's the current budget

Page 62

Page 64

1 that I suppose you can come up with a scenario that

1 here that we are in.

2 said I hired a thousand doctors to do nothing but take

2 Q. Okay.

3 care -- you can come up with a bizarre scenario like

3 A. We didn't know how many we could treat

4 that, yes.

4 physically with these operational, security and

5 Q. I understand you can label that bizarre. I'm

5 logistic wise. We're going to treat approximately 250

6 just testing it to see whether this is security or it's

6 this fiscal year.

7 something else.

7 Q. Okay.

8 A. Security in the sense of patients have to be

8 A. Just by the way its lined up. So our

9 moved, you know. You don't just give someone a pill.

9 recommendation is that we can probably treat more than

10 It's not just writing prescriptions. You give me a

10 that logistically and security and organizationally and

11 million dollars and I take 5,500 prescription pads and

11 all those kinds of things. And then our recommendation

12 write Harvoni and hand it out to people. It's not

12 is that we could treat up to 400, 450.

13 that.

13 Q. And is there an explanation as to why you will

14 Q. I understand that.

14 not be treating 450 this year, if you could do it

15 A. The point is is that there's nurses involved,

15 security wise, is it the cost?

16 doctors involved, security involved in moving inmates. 16 A. Well, because we only got a couple months left

17 Sometimes they have to go off-site for testing. There

17 to go. We've done 120 and we've seen the speed that we

18 have to be specialists involved. There are limitations

18 can get with these.

19 other than just pure cost of Harvoni.

19 Q. And what are you projecting for for the next

20 Q. And how many are you projecting to treat over

20 fiscal year, 2017-'18?

21 the next year?

21 A. I don't have a projection on budget.

22 A. 400 to 450.

22 Q. Okay, all right.

23 Q. So and of course, my hypothetical was based on 23

- - -

24 the notion that it would be very inexpensive. But what 24

(Whereupon, P-8 was marked for

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Page 65

Page 67

1 identification.)

1 looked at?

2

- - -

2 A. Veteran's Administration, Pennsylvania

3 BY MR. RUDOVSKY:

3 Medicaid, CCS's own corporate protocol.

4 Q. Let me explain to you, Doctor Noel, we asked

4 Q. So there were discussions with CCS about the

5 for in discovery emails that are related to Hep C

5 -- what the scope of the protocol ought to include?

6 treatment. And most of them are emails that you're on

6 A. Yes.

7 either receiving or sending an email from 2014 and

7 Q. Okay.

8 we've got them through near the end of 2016. I've

8

Did you look at what Medicare was

9 given you a pack of these emails. They're not all the

9 doing?

10 emails that we received, but their the ones I want to

10 A. No.

11 ask you some questions about, all right?

11 Q. Would it surprise you that Medicare was

12 A. All right.

12 providing DAA's to everybody with chronic Hep C?

13 Q. And so what I'll do, it's marked P-8, but I'll

13 A. I don't have any knowledge of that.

14 identify the particular email by the date of the email

14 Q. And when you say looked at Medicaid, why

15 so we'll know which one we're actually referring to.

15 wouldn't you look at Medicare also?

16 But before I ask you about the emails, it's my

16 A. The vast majority of our inmates are on

17 understanding that when the DAA's came out the

17 Medicaid insurance. So we looked at that not as

18 Department of Corrections and you, in particular, were

18 automatically doing whatever they do but because they

19 involved in a process of developing a protocol for the

19 generally come in on Medicaid and they go home on

20 use and distribution and or administration of the DAA's 20 Medicaid it's just sort of a good starting point for us

21 to certain inmates with Hepatitis C; is that correct?

21 to look at.

22 A. Correct.

22 Q. Right, but if somebody came into the prison

23 Q. And then at some point you developed an

23 with no insurance that wouldn't affect what kind of

24 interim protocol; is that correct?

24 medical care they got in the prison; isn't that right?

Page 66

1 A. Correct.

2 Q. And do you recall approximately the date that

3 was promulgated?

4 A. November, 2015.

5 Q. Okay.

6

And how long had you been working on

7 that protocol before it was actually published,

8 approximately?

9 A. Most of that year.

10 Q. Okay, so about a year.

11

And in that process I think you've

12 already said that you consulted with certain

13 organizations with protocols that other prisons had

14 developed, for example, the Federal Bureau of Prisons;

15 is that correct?

16 A. Correct.

17 Q. You looked at the AASLD recommendations?

18 A. Correct.

19 Q. Aside from those two, Federal Bureau of

20 Prisons and AASLD, did you look at any other protocols

21 or medical organizational recommendations for the use

22 of DAA's?

23 A. Yes.

24 Q. What else can you recall now as to what you

Page 68

1 A. Correct.

2 Q. Okay.

3

Did you look at the Center for Disease

4 Controls recommendations?

5 A. No.

6 Q. Okay.

7

And what was the working group that --

8 within the DOC that was developing and drafting this

9 protocol?

10 A. For the interim protocol?

11 Q. Yes.

12 A. Doctor Dean Rieger who at that time was the

13 Corporate Medical Director for CCS and Doctor Nicholas

14 Scharff who is a CCS physician who had been my

15 predecessor as the DOC Chief of Clinical Services and

16 had extensive knowledge but now he was on the private

17 side and was brought in for consulting also.

18 Q. Okay.

19

And during that period as you were

20 developing the interim protocol what treatment, if any,

21 was being given to inmates with Hep C regardless of

22 their stage from F0 to F4?

23 A. I don't know the exact timeframes. I don't

24 have that in front of me. There was a time where the

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Page 69

1 only ones that were receiving treatment were those that

2 came on treatment. There were no new starts while we

3 were sorting out the protocol and where the landscape

4 of the whole treatment in corrections was going.

5 Q. So if somebody came into the system from the

6 streets, was sentenced and they happen to be on the DAA

7 treatment outside you would continue it on the inside?

8 A. Always.

9 Q. Okay.

10

And why is that?

11 A. Because they were already on treatment. We

12 didn't want to interrupt something that already had

13 begun on the streets.

14 Q. Comparably, a few people, right, I mean, is

15 that --

16 A. Correct.

17 Q. Because we've looked through a lot of the

18 grievances and a couple that we've already noted and

19 were inmates were complaining I want the DAA's. They

20 were being told we're reviewing everything, we're

21 developing a protocol. At this point we're just going

22 to monitor your condition. Is that fair to say that

23 that's what was going on for a period of time?

24 A. Correct.

Page 71

1 Q. But for inmates who were diagnosed with Hep C

2 in the prison basically end of 2015, beginning of 2016?

3 A. Correct.

4 Q. And I understand the DOC tests everybody to

5 see if they've been exposed to the virus; is that

6 correct?

7 A. It's an opt out. They can say they don't want

8 testing.

9 Q. Right.

10 A. But absent that we test everybody.

11 Q. And when you started -- do you recall when the

12 DOC started testing inmates coming into the system?

13 A. For at least a decade.

14 Q. Okay.

15

And obviously, people have been there

16 longer than that. They've been there 20 years, 30

17 years, 40 years. Did you also then test everybody who

18 had been there before the testing of new inmates

19 occurred?

20 A. I'm not quite sure of that actually. I don't

21 know.

22 Q. Okay.

23 A. May I go back to my answer.

24 Q. Sure.

Page 70

1 Q. Okay.

2

The interim was published in as you say

3 November of 2015 and then the protocol that we'll

4 actually be talking about in a little bit, the current

5 protocol was published or promulgated when?

6 A. November, 2016.

7 Q. Okay, a year later.

8

And the changes, I assume, that were

9 made from 2015 to 2016 was based on new information you

10 learned, resources, things like that?

11 A. Correct.

12 Q. Okay.

13

What was the first year that you

14 started treating any inmates with DAA, if you recall?

15 A. Well, the protocol came out in November of

16 2015. I don't remember if there was enough time to get

17 someone started right then but we started immediately

18 in reviewing the charts.

19 Q. End of 2015, 2016?

20 A. Correct.

21 Q. But again, to be fair, except for those who

22 may have come in earlier that year who were already on

23 the drug?

24 A. Correct.

Page 72

1 A. It caught me off guard. I'm just trying to

2 think the way our system works. I don't believe there

3 was anybody in the DOC who has not been offered Hep C

4 testing if that's the question.

5 Q. Okay.

6

And maybe that's something you can

7 check, right? I don't want to hold you to it because

8 you don't know it. I'll follow up with some

9 interrogatories if we have to but I appreciate it. And

10 if anything else occurs to you as we talk, right, feel

11 free to amend or correct or change your answer.

12

So if we can refer now to the emails in

13 this exhibit. Start with the one dated Thursday,

14 August 14th from Doctor Rieger who you've identified to

15 you referring to a conversation he had with a

16 hepatologist from the University of Arkansas

17 for Medical Sciences. And there's a section here, he

18 responded to the AASLD product by saying that they

19 obviously did not consider any resource limitations in

20 their recommendations which call for treating all (yes,

21 all) incarcerated persons with HC infection.

22

So as of August of 2014 AASLD was

23 calling for treatment of everybody with HC infection

24 including incarcerated persons; is that correct?

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Page 73

Page 75

1 A. Yes.

1 Harvoni came out. There was large discourse across the

2 Q. Okay.

2 nation about where everything should be going. And so

3

Next email dated December -- well, it's

3 our goal was to get the sickest ones first and get them

4 a two page document, but it's dated December 28th.

4 going now.

5 Again, from Doctor Rieger to you. The bottom one

5 Q. But by that time AASLD had recommended

6 first because that's actually December 16th, let me

6 universally, right, across the board, for every

7 start with that one. And the email says to you you

7 prisoner --

8 asked that I send you the CCS HCV guideline. And I

8 A. Right.

9 indicated it had to go through a final review. Then it

9 Q. -- and it looks like CCS had at the same time

10 says as promised it walks away from the F3-F4 criteria

10 said yes, F3-F4 and then they revised it to the more

11 which were developed when our treatment options were 11 serious condition limited group; is that right?

12 much poorer. It is based more on mortality rates

12 A. Correct.

13 associated with esophageal varices in F4 than upon the

13 Q. Okay.

14 simple presence of serious fibrosis.

14

Next email dated -- from you to

15

What did you understand from that --

15 superintendents throughout the system it looks like in

16 CCS is Correct Care Solutions, right?

16 which you indicate that the DOC --

17 A. Correct.

17 A. Can I have the date, please?

18 Q. And then it says as promised it walks away

18 Q. Oh, yes, I'm sorry, you're right.

19 from one criteria and adopts another.

19

March 12th, 2014, the bottom one. The

20

What's your understanding of what CCS

20 DOC is reevaluating our treatment protocol given the

21 was recommending?

21 new guidance issued by the AASLD and the IDSA. As a

22 A. What we were looking at in the interim was to

22 result we will continue to monitor patients diagnosed

23 get those that were the most advanced in their disease

23 with Hepatitis while we evaluate our treatment options

24 process. And he was discussing as in the other email

24 moving forward and develop a new treatment protocol.

Page 74

1 that we should be looking at esophageal varices as one

2 of our guide posts.

3 Q. Well, what caused them to -- F3-F4 would

4 include more than the esophageal varices; isn't that

5 correct?

6 A. Correct.

7 Q. So they're moving from a regimen of treatment

8 for F3-F4 to a much smaller group?

9 A. Correct.

10 Q. And was there a reason given for that change?

11 A. Because there are those within the F4 that are

12 more serious than other F4's. And the F4's are more

13 serious than the F3's. So again, it was a

14 prioritization.

15 Q. Prioritization based on budget and money;

16 isn't that true?

17 A. I don't see the word money in there.

18 Q. I'm not saying it's there.

19

But what other reason could there be

20 for that change in treatment other than --

21 A. Lack of knowledge of what needed to be done.

22 The landscaping was changing about how to work these

23 patients up. There were no medications. It started

24 off with Sovaldi. We barely got going with Sovaldi and

Page 76

1

That was the status as of March 12th,

2 2014?

3 A. Correct.

4 Q. And then the email dated March 12th from you

5 to a number of officials including Mr. Wetzel

6 indicating our legal department had crafted a certain

7 announcement. And then stating no doubt you have heard

8 that the new guidelines include drug regimens that may

9 cost $80-$100,000 per treatment course.

10

So you reference the cost there; is

11 that correct?

12 A. I did.

13 Q. Okay.

14

I'm going to skip the next one and move

15 to --

16 A. May I ask a general question?

17 Q. Yes.

18 A. Are these in chronological order?

19 Q. Yes, they are, they are.

20 A. Thank you.

21 Q. That's what I'm trying to do here, yes.

22

Next one which indicates Friday, March

23 14th, 2014 from you to Michael Hodge. And who is

24 Michael Hodge?

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Page 77

Page 79

1 A. He's one of the QI nurses in the Bureau of

1 have been tasked with treating those in who it is --

2 Health Care Services.

2 and then in bold, medically necessary, end of bold to

3 Q. You reference the AASLD guidelines that state

3 eliminate the virus from their body. That would be

4 patients with fibrosis of 0 to 2 can be delayed until

4 everybody with chronic Hep C; isn't that right?

5 updated guidelines are developed.

5 A. Not under -- not in this context. That's not

6

What are you referring to as of

6 what I was referring to.

7 March 14th, 2014?

7 Q. What else would you be saying? We have been

8 A. My recollection, and again, the AASLD has a

8 tasked with treating those in whom it is medically

9 website so it's difficult sometimes because it's

9 necessary to eliminate the virus from their body.

10 updated and you lose the history sometimes. My

10 A. Those would be ones that would be suffering

11 recollection is when they first came out that there was

11 irreparable harm of which is not everybody who has the

12 some language in there that I would have referenced

12 virus.

13 that showed that maybe not everybody needed to be

13 Q. And irreparable harm in your mind at that

14 treated right away.

14 point meant what?

15 Q. I've seen some of the early versions also.

15 A. Could not be reversed.

16 One reference was to the inability to get the drugs. I

16 Q. At what point does the damage to the liver get

17 mean, obviously, if you can't get the drugs then you

17 reversed by the cure?

18 got to prioritize. But aside from that, anything else

18 A. It's debatable. Most of the science will say

19 you recall specifically?

19 that cirrhosis is permanent. But there actually is

20 A. I do not.

20 literature out there that people can find if they want

21 Q. Okay.

21 to try and debate that. But for just the general

22

If you go to the next one dated May

22 primary care physician type things in a big setting

23 21st, 2014 from you to Mr. Oppman and several others.

23 like this we sort of look at the cirrhosis as fairly

24 Here you refer to tracking about 5,900 inmates who have 24 permanent. And it's also fairly well established that

Page 78

1 been diagnosed with Hepatitis C. Again, I don't want

2 to hold you to it. You said 5,500. Are we talking

3 somewhere between 5,500 and 6,000?

4 A. Correct.

5 Q. Okay.

6

Is it fair to say that much of this

7 email is concerned with the cost --

8 A. Yes.

9 Q. -- of providing DAA. In fact, you in bold say

10 that at $84,000 per patient that 5,900 inmates were

11 close to $500,000,000; is that right?

12 A. That's correct.

13 Q. Nothing in this email about security,

14 limitations, space, staffing as inhibitions on

15 providing DAA's to everybody in the system?

16 A. Well, let me read it, please.

17

Actually, I did even put a caveat in.

18 Paragraph 3, next to the last sentence. I did even say

19 from a purely clinical perspective there's even debate

20 as to whom that includes. But this was in response to

21 budget meetings of what and fiscal of which the budget

22 is directed.

23 Q. I understand that. And in fact, in that

24 paragraph you just mentioned you have the statement we

Page 80

1 if you have fibrosis the fibrosis does have regression.

2 Sometimes just without treatment and sometimes with

3 treatment. So our focus on the medically necessary in

4 the context of this was to target the patients with

5 cirrhosis.

6 Q. So once you reach the cirrhosis stage you

7 don't -- even with a cure, right, with DAA's, you still

8 have cirrhosis of the liver. You've eliminated the

9 virus but you still have cirrhosis of the liver?

10 A. There is some literature that says that you

11 can even have some regression from cirrhosis.

12 Q. Some will, some won't?

13 A. Correct.

14 Q. Fibrosis, Stage III, cure with DAA, isn't it

15 true that some of those patients will still have the

16 fibrosis?

17 A. Yes.

18 Q. And can some of those patients even progress

19 to cirrhosis after that?

20 A. I don't know that.

21 Q. Okay.

22

The next email, August 1st, 2014. This

23 references the fact that the treatment in 2013 cost

24 $1.5 million. Of course, we're not talking about DAA

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Page 81

1 treatment there. We're talking about different kinds

2 of treatment, right?

3 A. Correct.

4 Q. Okay.

5

And then you reference the much higher

6 cost now at $88,000 per patient. And you say we have

7 not approved any new patients to begin this treatment

8 as both medical and governmental organizations review

9 these new regimens in light of enormous expense.

10

That's what you state, right?

11 A. Again, this email is directed to Kitty Large

12 who is a staff budget person. This is a budget email.

13 Q. This is a budget email which is why you're

14 referencing the cost --

15 A. Correct.

16 Q. -- and considerations of cost in the

17 treatment?

18 A. Correct.

19 Q. Okay.

20

Next one, and now we're in 2015,

21 January 16th to Mr. Ginchereau and Doctor Scharff. You

22 say thanks for the review of the Federal Bureau of

23 Prisons guidelines and your recommendation that we

24 treat APRI more than 1.0. I double-checked my data

Page 83
1 itself. 2 Q. Okay. 3 A. It has nothing do with the individual as a 4 patient. And it's important because you have different 5 drug regimens that are recommended for different 6 genotypes. 7 Q. Next one, February 11th, 2015, referring that 8 the budget request to treat Hepatitis C with 9 medications is $4,665,000. And then you say we'll have 10 the narrative and details typed up before noon. So 11 that's the limitation for you for treatment for that 12 budget year, right? Your DAA's will be limited to 13 $4,665,000? 14 A. I think that's backwards. In a sense of we 15 figure out how many patients we can treat and then we 16 say how much that's going to cost. I don't go in -17 I'm not a dollar -- I don't go in and say the budget 18 amount. 19 Q. Okay. 20 A. I come up with how many patients we're going 21 to treat and then calculate what the cost is and then I 22 go to the budget office and say this is a 23 recommendation. 24 Q. Right, and then do you know if you got that

Page 82

1 from the report I ran after their guidelines were

2 released last year. Out of 6,000 DOC inmates who were

3 Hep C, 700 had an APRI score of greater than 1.0. For

4 purposes of establishing the magnitude of treating them

5 all, it would be 700 x $100,000 or $70 million in bold.

6 Somehow, I'm going to have to further prioritize this

7 number.

8

The only prioritization factor you talk

9 about is cost?

10 A. Correct.

11 Q. And so basically what you're saying here is we

12 can't do it at 1.0 even though that might be the VBOP

13 guidelines. We're going to have to find a higher APRI

14 score; isn't that right?

15 A. That's what this particular email says, yes.

16 Q. Okay.

17

Just a question on the next one,

18 February 7th, there's a reference to genotypes and the

19 different numbers of inmates at each genotype. Just

20 quickly, Doctor Noel, what does a genotype refer to in

21 terms of Hep C?

22 A. These are subgroups within Hepatitis C. So

23 not all Hepatitis C is equal. These are subgroups of

24 those based on technical aspects of the actual virus

Page 84
1 amount that year? 2 A. Actually, what happened if we're going to talk 3 about that year is that I base that again on the number 4 of patients I could treat. I came up with a number and 5 then I calculated the cost, some of which was the 6 genotypes because there's different regimens and came 7 up with a dollar amount, okay. That amount was granted 8 in the budget. As it turns out through negotiations we 9 got the price down. I treated the same number of 10 patients, that didn't change, that was the constant. 11 The variable was the cost which came down and we 12 actually only spent $3,200,000, not because we treated 13 less patients, but because the absolute cost of the 14 medication was less. 15 Q. And we'll get into what the -- well, let me 16 ask you this, what was the measure that you were using 17 for who you would treat and who you wouldn't treat at 18 that time? 19 A. I don't remember all the details, but it was a 20 combination of who were the F4's looking at cirrhosis 21 patients, the workup that was needed to evaluate them, 22 off-site services, staff that we had, hepatologists. 23 All those nonfinancial variables went into coming up 24 with what we thought was a reasonable number for that

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Page 85

1 particular fiscal year.

2 Q. Next one, April 10th of 2015. Your email

3 stating we have cost referenced this list of Hep C

4 patients who have an APRI of greater than 2.0 with

5 minimum/maximum dates and come up with 75 who will be

6 here beyond 2020.

7

What's the rationale for limiting DAA

8 treatment to those with an APRI score of above 2.0 who

9 will be there as of this email would have to be there

10 for at least 5 more years?

11 A. This was just part of our brainstorming. This

12 actually did not come to fruition. It was just an

13 email of thinking of different ways to get the sickest

14 patients taken care of. I don't remember the exact

15 logic behind this. We discarded the notion.

16 Q. Okay.

17

July 7th, 2015, again, from you to

18 several others in the DOC. One last question, how did

19 we (probably me) come up with 12 months as the

20 exclusion time period for time of incarceration, drugs,

21 tattoos and general medical compliance? And then you

22 say Federal Bureau of Prisons has no such restrictions.

23 The VA specifically states there are no published data

24 supporting a minimum length of abstinence as an

Page 87
1 standard to take them off the medication? 2 A. I don't know. 3 Q. And that's what I'm saying, do you know of any 4 other condition, diabetes, somebody is not following 5 the proper diet, heart disease, they're not doing the 6 proper exercise, whatever it might be where the medical 7 -- a medical expert or practitioner would withhold a 8 cure because the patient or some other treatment 9 regiment because the patient is doing things in their 10 life that's kind of contraindicated given their 11 condition? 12 A. Well, in the sense of you talk about community 13 standards Pennsylvania Medicaid seemed to think it was 14 a community standard. You can make a strong case that 15 there is -- they're more of a community standard in the 16 State of Pennsylvania than a lot of others. And they 17 actually had a 6 month abstinence. So I had different 18 opinions of which I was sorting them out as we moved 19 through this. So in answering that question, are there 20 others, Pennsylvania Medicaid does. 21 Q. Did you get any response to that email from 22 Doctor Sharff or others? 23 A. I don't remember. 24 Q. We didn't have anything in what was given to

Page 86

1 inclusion criterion. Pennsylvania Medicaid has 6

2 months abstinence. I am still OK with this criteria.

3 I'm just not sure how to answer anyone who would

4 challenge them, other than say they're reasonable.

5

Doctor Noel, aside from these

6 compliance requirements that you have for the inmates,

7 no tattoos and others, is there any other disease in

8 the DOC or in the outside world that doesn't get

9 treated because the patient is not compliant?

10 A. I'm not sure that compliant is the word that I

11 would use in this other than the medical regimen one.

12 Q. Right, I understand medical regimen, you got

13 to take the pills.

14 A. Right, so we'll look at the general -- and we

15 do that with others. If it's their HIV medications and

16 they take them sporadically, they absolutely are

17 stopped on their medications.

18 Q. And I'm not talking about that. When we get

19 to the protocol I noticed things like tattoos --

20 A. The one with tattoos and drugs means that

21 they're involved in high risk behavior to reinfect

22 themselves.

23 Q. And if somebody is on HIV medication and they

24 get involved in high risk behavior is it the national

Page 88

1 us.

2 A. I don't remember. I did not get an email

3 response or I would have given it to you.

4 Q. No, I understand that. I'm going to skip the

5 next one and I'm going to move to August 20th, 2015.

6 And there's an exchange here regarding patients who are

7 unstable. Just generally, what are you referring to

8 there in terms --

9 A. My top email here?

10 Q. Yeah, we're on the same one. If you look at

11 the bottom email, 11:58 a.m., from Dean Rieger. I just

12 completed looking over IAS, WHO, VA and a few other

13 entries in the guideline world and could not find

14 useful commentary regarding a definition of unstable.

15 You then respond that you were trying to define

16 unstable for a check off form.

17

I'm just wondering what this exchange

18 is all about?

19 A. With the previous medications of Interferon in

20 the Interferon days there were specific numbers that

21 correlated with the definition of not being medically

22 stable such as a certain number with the hemoglobin

23 AIC. There were still language that a contraindication

24 might be that a patient had a severe medical condition

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Page 89

1 that was not stable. It's just we didn't have a

2 definition of it.

3 Q. So the concern was someone who might be

4 eligible for DAA treatment there may be a

5 contraindication because of another medical condition

6 which you would then say makes this patient unstable

7 and perhaps it's not proper to treat them with DAA's?

8 A. Correct.

9 Q. Okay.

10

And in the protocol that you finally

11 came up with, we'll get to it, I forget now. Did you

12 have a provision in which you would exclude certain

13 patients based on a case by case basis because of that

14 instability?

15 A. I'm pretty sure we put a general statement and

16 then we instructed the site medical director that if he

17 had any questions about it because there was no

18 specific criteria to refer it to us at the committee

19 and we would discuss it with the hepatologist and see

20 if there was a specific case by case basis. Again,

21 this does not address the vast majority.

22 Q. No, I understand that.

23

Okay, if you would go to the next one

24 which is actually dated March 25th, I apologize, it's a

Page 91

1 Q. Okay.

2 A. Which is what he would be involved with as the

3 pharmacist he only knows the cost of the medication.

4 Q. All right.

5

The next one is June 30th, the top

6 email and we'll get to the protocol. But you say as of

7 June 30th for purposes of this protocol (an important

8 distinction), we're defining cirrhosis based on the

9 platelets/HALT-C. So you have to have cirrhosis before

10 it can decompensate, correct?

11

What were you looking for there, what

12 was your question there to Doctor Rieger?

13 A. Well, within cirrhosis there are two

14 subcategories of compensated and decompensated.

15 Decompensated is more severe. So you want to treat the

16 decompensated immediately even before you get to the

17 compensated. All could be done in the same short

18 period of time, but it's prioritization. So I was

19 asking for some technical definitions of how we -- for

20 the protocol purposes how we will define decompensated

21 versus compensated.

22 Q. Okay.

23

The next one is August 10th and it says

24 the new Hepatitis C protocol is in the Executive Suite

Page 90

Page 92

1 little bit out of order but the response is to a

1 under final review. When you say Executive Suite is

2 lawsuit that was filed.

2 that Mr. Wetzel's office?

3

MR. MAZESKI: I'm sorry, Counsel,

3 A. Yes.

4 there's two March 25th emails?

4 Q. Okay.

5

MR. RUDOVSKY: This is the one at 10:10

5

In other words, they would have to

6 a.m.

6 approve -- Wetzel or somebody on his staff would have

7

MR. MAZESKI: Okay.

7 to approve the protocol?

8 BY MR. RUDOVSKY:

8 A. They sign off on all protocols.

9 Q. And this is from you to Mr. Gabrielson who is

9 Q. Okay.

10 who?

10 A. Policies.

11 A. He is our representative with the pharmacy,

11 Q. All right.

12 Diamond Pharmacy.

12

The email dated September 10th, 2015,

13 Q. And you pose a question to him about cost for

13 you reference final review of the new Hepatitis C

14 treatment in Paragraph 4. And you say Plaintiff's

14 Policy. Indicating you chose a cutoff of a platelet

15 claim is that he was denied HCV treatment because of

15 count of less than 75,000 which was about 81 patients.

16 cost. And while we will counter that it was because of

16 What was the reason for picking a platelet count of

17 the release of Sovaldi and the need to find a new

17 less than 75,000?

18 protocol, he'll be allowed to make some argument. Some 18 A. During our own experience with Hepatitis C and

19 round number for the per patient, per month cost or

19 trying to find some measure to put into a protocol for

20 something similar ought to suffice.

20 evaluation we found a small cohort of patients that

21

So again, the reference here is only to

21 didn't fit into our normal criteria. And those are

22 cost, not security issues or anything else; is that

22 ones that had a low platelet count but may have had a

23 right?

23 satisfactory APRI score or a satisfactory HALT-C score.

24 A. That's what that paragraph says, yes.

24 And when I say satisfactory, did not indicate that they

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Page 93
1 needed immediate treatment. But we actually found that 2 there was a small cohort that although they didn't meet 3 treatment by some of that criteria they had low 4 platelet counts that tended to show that maybe they 5 were in advanced fibrosis or cirrhosis. So what we did 6 is we added that as just another little category from 7 what we learned from our own experience, not so much 8 from the literature and was an addition, not a 9 limitation of the numbers. 10 Q. The next one is October 5th to Christopher 11 Oppman. And who is Mr. Oppman? 12 A. At this point there's a part in the transition 13 I don't know the exact timeline he at one time was the 14 Director of the Bureau of Health Care Services. At 15 some point in this time he was promoted to Deputy 16 Secretary for Administration which is one level above. 17 And I'm not quite sure at this point -- I take it back. 18 So a copy to Andrea Norris. So Andrea Norris was the 19 Director of the Bureau. So at this time it was Deputy 20 Secretary Oppman. 21 Q. And this email refers to the additional cost 22 under the new Hepatitis C protocol. So as of October, 23 2015 based on your prior testimony that interim 24 protocol was not yet out, right, it was about to be

Page 95

1 which is a three page document in reverse order by

2 dates. The tope one is dated January 22nd, but I want

3 to go to the second page and the email dated January

4 21st, 2016 at the bottom.

5 A. Okay.

6 Q. You refer to six Hepatitis C Treatment

7 Referral Forms for patients at Laurel Highlands. And

8 there's an indication here that the abnormal scores

9 appear to be more a function of renal disease as

10 opposed to the liver disease. What's the concern

11 there, isn't it true that Hep C often has

12 manifestations outside the liver?

13 A. It does and that's why I was deferring to

14 Doctor Cowan with that question.

15 Q. All right, okay.

16 A. That's simply deferring to Doctor Cowan

17 because they did not meet the criteria based just on

18 APRI scores. So I'm asking his opinion.

19 Q. Okay.

20

And the email right above that from Jay

21 Cowan to you references this particular group and

22 references what has to be taken into account in terms

23 of treatment or nontreatment, right?

24 A. I'm just skimming over it. That appears to be

Page 94

1 published in November, I think?

2 A. Correct.

3 Q. And you state in this email that at a sticker

4 price of $100,000 for course of medication you're

5 budgeting $5 million which would allow you to treat 50

6 patients; is that correct?

7 A. Correct.

8 Q. So what was the driving factor here the number

9 of patients who needed treatment or the limitation of

10 the $100,000 times that 50?

11 A. Well, again, from my standpoint -- no one told

12 me $5 million. Again, we didn't know a lot of things

13 about the drugs. And our working the patients up and

14 getting them evaluated and finding the ones that were

15 most need of immediate treatment we didn't know what we

16 could do. So we wanted to get the ones that were

17 sickest. And just through -- before we actually

18 evaluated looking at some data we had it seemed that

19 there were probably 50 that we wanted to treat right

20 away to preclude any irreversible permanent damage.

21 And so those are the ones that we targeted. And then I

22 backed into the dollar amount from that.

23 Q. Okay.

24

I want to now look at the next document

Page 96

1 what that is, yes.

2 Q. And in fact, the statement from -- and who is

3 Jay Cowan, by the way?

4 A. At this point in time he is both the Statewide

5 Medical Director for the Pennsylvania contract for CCS

6 and he's also the hepatologist for this program.

7 Q. Okay.

8

And I just want to reference the last

9 sentence in the first paragraph.

10 A. I need the email again.

11 Q. So it's the January 22nd, 11:09 email on the

12 second page.

13 A. Okay.

14 Q. Where he's taking about patients with severe

15 renal disease. He says the first step should be to

16 assess life expectancy, identify all comorbidities and

17 then consider whether treatment of Hep C infection

18 would provide a survival benefit. In other words, is

19 he saying only provide the treatment if it's necessary

20 to literally save his life?

21 A. I would have to ask him that.

22 Q. Okay.

23 A. At this point I had turned all care of Hep C

24 patients on dialysis over to the hepatologist and

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Page 97

1 nephrologist.

2 Q. Okay.

3

The February 18th email from you to

4 Mr. Keldie and Mr. Ellers responding to recommendations

5 on updated the Hepatitis C protocol. And you state the

6 following, I do not doubt that elastography science or

7 the improvements in defending the protocol, but I need

8 to operationalize this within our current fiscal

9 realities. It does not help us if the use of

10 elastography provides us a bucket of potential patients

11 which is too large to treat in a timely fashion.

12

What did you mean by that?

13 A. Well, first of all, it has to do with numbers

14 again. I'll go backwards and a bucket of potential

15 patients which is too large to treat in a timely

16 fashion actually speaks to the issues of

17 operationalizing and security and moves away from the

18 cost factor in the sense of if we did elastography and

19 there were 500 patients identified we would have to

20 still prioritize, couldn't treat them all.

21 Q. Even though the elastography would indicate

22 these people need treatment with the DAA's?

23 A. We would need to still refine that into

24 prioritizing.

Page 99

1 that we will start with the highest APRI scores and

2 work our way down to 1.5. We might not get all of them

3 this fiscal year. Almost 200 of the above have APRI

4 above 2.0 but those have many of the ones we already

5 addressed.

6

So if I read this correctly, you've

7 identified an APRI score of 1.5 or higher as those who

8 should be treated with the DAA's. But for fiscal

9 reasons you won't be able to do that in that year?

10 A. No, that's not at all what we did.

11 Q. Then what are you saying?

12 A. The score of 1.5 or higher indicates those

13 that will go to elastography.

14 Q. Okay.

15 A. That is not a treatment decision, that is a

16 testing decision.

17 Q. And then what is meant when you say I'll put

18 in the caveat we'll start with the highest APRI scores

19 and work our way down but we might not get to them all

20 this fiscal year?

21 A. Just because they had to go off site to a

22 central location.

23 Q. Okay.

24

The next one, the September 9th email

Page 98
1 Q. And the prioritizing says fiscal realities. 2 It doesn't say anything about inability to treat. It 3 sounds like it's lack of money? 4 A. No, because the elastography has to do with 5 the movement of patients. We have to take them to 6 another site actually to have the test performed and do 7 screening exams and sonograms. So it's a huge 8 operational issue. 9 Q. I understand that. But it looks like what 10 you're saying, correct me if I'm wrong, but that issue 11 is a fiscal issue? 12 A. The point I was trying -- it was not purely a 13 dollar issue. The point I'm trying to make in this is 14 that we can only treat so many in a timely fashion. We 15 can't treat everybody this year. 16 Q. I'm going to skip the next one and I'm going 17 to move to August 20th, 2016 from you to Mr. Cowan and 18 Mr. Keldie. You reference the Federal Bureau of 19 Prisons guidelines for prioritization. And you're 20 saying in terms of who you're going to schedule for 21 elastography your replacing the HALT-C test with the 22 APRI score. And you indicate a score of 1.5 or higher 23 looks good and we have a little over 300 including 24 those treated. You then say I will put in a caveat

Page 100

1 refers to the current cost for Sovaldi and Harvoni,

2 right?

3 A. Historical, right.

4 Q. The historical cost, right, okay.

5

Looking at the next one, January 11th,

6 2016 where you're referring to what you call the latest

7 batch of Hepatitis C referrals. And you indicate that

8 the EGD triggers the referral to you and will be

9 current. What do you mean by that, what are you

10 referring to there?

11 A. This is under the interim protocol --

12 Q. Right.

13 A. -- the results of the EGD determining whether

14 or not the patient had esophageal varices was a

15 decision point. And if they had esophageal varices

16 then they would be referred on to Doctor Cowan to

17 determine the exact medications to be used.

18 Q. That's right, I understand and I appreciate

19 that. But it means as a predicate you won't get to the

20 DAA treatment unless you have the EGD that's referred

21 to here? That's what triggers the referral?

22 A. Correct.

23 Q. Okay.

24 A. I mean, there is some caveat and some unusual

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Page 101

1 circumstances. But the general gist of the interim

2 protocol was utilizing EGD results in defining those

3 who were in need of the treatment more urgently.

4 Q. Okay.

5

Let me move a couple more to the

6 February 3rd, 2016 from you to Mr. Cowan and Mr.

7 Ellers. This is still under the interim protocol; is

8 that correct?

9 A. Correct.

10 Q. Okay.

11

You're giving them a status of the Hep

12 C Program. And you state that you're not on track for

13 our target of 50 patients by July 1st. You reference

14 the number of patients you have. And what was the

15 problem there, did you ever get a response to that or

16 what the problem was?

17 A. Well, as I said before when we set up the

18 fiscal year target I wanted to treat 50 patients during

19 that fiscal year. And we are now in February and at

20 the rate we were going we would not get to 50. So we

21 would be short of the target. So I was putting the

22 email out to try and see some feedback as to what was

23 going on.

24 Q. I'm going to have to ask you to go back a few

Page 103

1 Cathers; do you see that one?

2 A. I do.

3 Q. At the bottom actually the one I want to refer

4 to is the email at 9:25 a.m.

5 A. I have it.

6 Q. Where you say you're revising the Hep C

7 protocol. And you say that Secretary Wetzel wants us

8 to be in line with DHS. What are you referring to

9 there?

10 A. That's Medicaid. Pennsylvania Medicaid,

11 Department of Health Services.

12 Q. And Medicaid has its own protocols and

13 standards for which medication patients will get --

14 A. Correct.

15 Q. -- the DAA's right?

16 A. Correct.

17 Q. And the secretary was saying we ought to be

18 following Medicaid in terms of the DOC policy?

19 A. In line with, yes.

20 Q. Okay.

21

And has that ever been done?

22 A. We actually supersede them now. We treat --

23 their current -- I stand corrected on that. Let me

24 back up, that was not correct. I believe their current

Page 102

1 documents which you already turned. I'm looking for an

2 email that's dated February 18th, 2016. It's about 8

3 or 9 back.

4 A. Okay.

5 Q. And it's to Carl; do you see that? Thanks for

6 sharing your recommendations?

7 A. Yes.

8 Q. Okay.

9

It reads thanks for sharing your

10 recommendations on how to update our Hepatitis C

11 Protocol. I do not doubt the elastography science or

12 the improvements in defending the protocol, but I need

13 to operationalize this within our current fiscal

14 realities. It does not help us if the use of

15 elastography provides a bucket of potential patients

16 which is too large to treat in a timely fashion.

17

What are you referring to there?

18

MR. MAZESKI: Objection, we asked and

19 answered that already.

20

MR. RUDOVSKY: All right, okay, I'm

21 sorry, okay.

22 BY MR. RUDOVSKY:

23 Q. Let me move back now. The next one I want to

24 refer to is Wednesday, May 25th from you to Terri

Page 104
1 one is to treat F4, 3 and 2. 2 Q. And are you aware that there are negotiations 3 going with them where they have now agreed within the 4 next year to treat everybody with chronic Hep C? 5 A. I've heard water cooler talk. There's nothing 6 been put out anywhere formalizing anything. 7 Q. But you've heard that those discussions are 8 ongoing? 9 A. I've heard those discussions, yes. 10 Q. But in any event, at this point Medicaid of 11 Pennsylvania was giving this drug to more to a larger 12 group of persons than the DOC was? 13 A. They didn't even prioritize. The way I read 14 it is that if you have an F0 or 1 you actually are not 15 eligible for treatment. Our protocol you are eligible 16 but you are on the lowest list of prioritization. So 17 you can look at that two different ways. 18 Q. Has there been a single person -19 A. No. 20 Q. -- in the history of the DOC that has been 21 treated at F0? 22 A. No. 23 Q. F1? 24 A. No.

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Page 105

1 Q. F2?

2 A. Not that I know of but there may be some --

3 there are extra hepatic manifestations that fall within

4 those categories and stuff. But not purely on liver

5 disease.

6 Q. Okay.

7

How about F3?

8 A. Have we treated F3, oh, many, many.

9 Q. With DAA's?

10 A. Absolutely.

11 Q. How many in the last fiscal year?

12 A. I don't have --

13 Q. I know you don't have the exact number but an

14 approximation?

15 A. Well, in this fiscal year we have treated 120

16 patients to date with either F3 or F4. And we are on

17 target to treat another 120 with F4 or F3 by the end of

18 this fiscal year. At that time I believe we will have

19 addressed and either treated or excluded everyone known

20 to have F4 or F3. And the plan is then to move into

21 the F2 list realizing that we're going to have people

22 come in to the system that are already F3 and F4 and of

23 course they'll have the highest priority. But

24 beginning July, 2017 we will begin looking at the F2's.

Page 107

1 120 already. This is for this current fiscal year.

2 And we're on target to do another 120. The updated

3 goal from this email was 240 this fiscal year.

4 Q. Okay.

5

The September 4th email which

6 references the fact -- I assume it's drafting of the

7 protocol we're operating under now. But you reference

8 the fact that the final document needs approval by the

9 secretary; is that right?

10 A. Yes.

11 Q. Okay.

12

So the current protocol that we're

13 operating under was actually authorized by Secretary

14 Wetzel?

15 A. Just to be clear, Secretary Wetzel signs off

16 on every policy in the DOC, has final authority.

17 Q. He's got final authority to do that?

18 A. On every policy within the DOC.

19 Q. Okay.

20

I'm going to skip the next one and I'm

21 going to go to the last email or last batches of emails

22 in September 13th, 2016. But I want to spends a little

23 bit of time on this one. It's an email from you to

24 several others in the DOC which is your corrected

Page 106

Page 108

1 Q. On that same document that I just referred to

1 version of an attachment. And the attachment -- we

2 Secretary Wetzel there's two emails in response. The

2 have the attachment there and it says Hepatitis C

3 first from Terri Cathers saying that the pharmacy and

3 treatment-radical. I just have a question about that

4 therapeutics committee met on May 17th, 2016 and

4 title. First of all, who drafted that and what was the

5 recommended that the department eliminate evaluation of

5 meaning? It looks like a proposal for Hep C treatment

6 fibrosis scores from prior authorization guidelines.

6 and what's meant by the term radical?

7 Do you know what she's referring to there?

7 A. I drafted it. I put that catchy little phrase

8 A. I think what you just brought up.

8 so I could find it again, actually. I had difficulty

9 Q. Okay.

9 finding all my various drafts and proposals and things

10 A. That they're looking to possibly change their

10 like that with Hepatitis C. I'm not very

11 guidelines. And this is what we were hearing talk of

11 technologically savvy. So I picked that catchy little

12 but there's nothing in the documents.

12 phrase because it was something I was working on so I

13 Q. Okay.

13 could find it again much to my chagrin. That's all

14

The July 14th email references a

14 that was.

15 tentative budget for the coming fiscal year, 2015-'16

15 Q. Okay, so let's talk about the substance here.

16 of $10.2 million in order to treat 170 patients; is

16 You start off by saying that the APRI score which you

17 that right?

17 had been using, right, as a measure of who to treat and

18 A. Correct.

18 who not to treat as of that time has significant

19 Q. Okay.

19 limitations; is that correct?

20 A. Which has been adjusted.

20 A. That's correct.

21 Q. It has been --

21 Q. Okay.

22 A. Adjusted.

22

And then you go on to say given that

23 Q. Okay, in what way?

23 although we cannot state this with medical certainty,

24 A. This is the one where I told you we've done

24 generally speaking, a patient with an APRI score of

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Page 109
1 less than 1.5 is unlikely to be in immediate danger of 2 developing permanent liver damage within the next year 3 and you go on to say certain things. So are you saying 4 here that an APRI score of less than 1.5 there will be 5 some individuals who may be in immediate danger of 6 developing permanent liver damage within the next year? 7 A. I wasn't saying that. I was just trying to 8 make sure everybody understands when we use these 9 scores that they're just not rock solid science. 10 They're not absolutes. So that was just sort of 11 putting wiggle room in that. I don't have any specific 12 knowledge about correlating lower APRI scores with 13 developing cirrhosis and irreparable damage. These 14 scores are not absolute. That was my message. 15 Q. I have a couple of questions about the APRI 16 score, actually. Because in a number of the documents 17 it talks about a sensitivity level and a specificity 18 level. You're familiar with that terminology? 19 A. Yes. 20 Q. And there's a document which I'll get to that 21 with using a score of 2.0 or higher as a measure for 22 DAA treatment that the sensitivity level of that score 23 is only 48 percent. Does that mean your missing half, 24 possibly half the people who should be treated?

Page 111

1 correct?

2 A. Correct.

3 Q. Okay.

4

And in fact, all the major medical

5 organizations now say you should use elastography and

6 direct biomarkers for determining if you're going to

7 prioritize at all which patients to give the DAA's to?

8 A. I have no knowledge of that statement.

9 Q. Okay.

10

And I think I referenced this when we

11 looked at the AASLD guidelines where it said the APRI

12 was not sensitive enough to rule out substantial

13 fibrosis. So using the APRI score itself you can miss

14 people with substantial fibrosis?

15 A. You can.

16 Q. Okay.

17

Have you -- on this question of who to

18 treat and what the cutoff is consulted with Doctor

19 Hauser at the Pennsylvania Department of Health?

20 A. Yes.

21 Q. And what have you consulted with him about in

22 terms of the treatment in DOC?

23 A. He's the coordinator for Hepatitis C

24 epidemiology in the Department of Health. So we just

Page 110

1 A. Who have -- if you're using that to define

2 cirrhosis, then there could be those that have lower

3 scores that might have cirrhosis.

4 Q. Right.

5

And so -- and the 2.0 was the number

6 you were using for quite some time, right, as a cutoff?

7 A. In prioritizing, yes. Again, prioritizing,

8 not excluding.

9 Q. I understand that. But from that there would

10 be at least as many at least approximately. It looks

11 like it's 50/50 who you are treating and those who

12 you're not treating because APRI is a very I would say

13 blunt, right, measure. It's not very precise.

14 A. It's as precise as anything that we have.

15 Q. More precise than elastography and direct

16 biomarkers, that can't be right?

17 A. Elastography is not absolute. I don't know

18 the exact number of whether one is 50 and 60. But all

19 of these are indirect markers absence pathological

20 post-mortem examination. Elastography is better but it

21 is still -- they all have limitations.

22 Q. I understand limitations. But APRI score is

23 more limited than elastography and more limited than

24 elastography with direct biomarkers; isn't that

Page 112

1 shared general data. He's mostly interested in

2 epidemiological data. And he's a point of contact for

3 me in the Department of Health for just asking

4 questions in general about Hepatitis C landscape and

5 the Commonwealth.

6 Q. Okay.

7

I want to ask about this question of

8 APRI scores and elastography and biomarkers. If

9 elastography and direct biomarkers is a better and more

10 accurate measure why isn't the Department using that

11 now as opposed to APRI scores?

12 A. Actually, we've gone above and beyond to my

13 knowledge every Department of Corrections system at

14 least most of them in even going to elastography. But

15 we purchased a machine and put it in a central

16 location. But we have to move everybody to that

17 central location to have the elastography.

18 Q. And is it just a financial question of not

19 having that elastography machine in every unit in the

20 Department of Corrections, every prison?

21 A. No one has brought that up as a possibility

22 actually to even go through that. So you're saying why

23 don't we just have an elastography machine everywhere?

24 Q. Yes, if that's the most accurate measure of

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Page 113

Page 115

1 who needs DAA treatment?

1 A. Correct.

2 A. We haven't actually had that discussion for me

2 Q. Okay.

3 to answer that.

3 A. It's the most efficient approach. It doesn't

4 Q. Okay.

4 say anything about recommendation, but that is the most

5

Is FibroSure used at all in making this

5 efficient approach.

6 determination? I understand that's a blood test of

6 Q. Okay, all right.

7 some kind?

7

- - -

8 A. It's a similar type of blood test. We do not

8

(Whereupon, a brief discussion was held

9 use that in our protocol. If someone comes in --

9 off the record.)

10 again, in our protocol if someone comes in and they've

10

- - -

11 had a FibroSure test already from some other source we 11

(Whereupon, a brief lunch break was

12 would not exclude it. We would take it into

12 taken at this time.)

13 consideration in our review of the case. But it's not

13

- - -

14 part of our protocol.

14 BY MR. RUDOVSKY:

15 Q. And going back to this document again and

15 Q. Doctor Noel, I'd like to go to the current

16 elastography, you reference the fact that you can

16 protocol.

17 transfer 15 patients to SCI Benner once a month for

17 A. Okay.

18 elastography. And then you say this could be increased 18 Q. Actually, before I do that let me have this

19 to twice a month for a total of 30 a month. And the

19 marked as the next exhibit.

20 superintendent has agreed to that possibility. But

20

- - -

21 again, there's no discussion here about having more

21

(Whereupon, P-9 was marked for

22 elastography machines at different sites; is that

22 identification.)

23 correct?

23

- - -

24 A. Correct.

24 BY MR. RUDOVSKY:

Page 114

1 Q. But using APRI score in this document you

2 calculate the number of patients who could be provided

3 with DAA depending on what the cutoff is 1.5 to 2.0 or

4 above 2.0. And it looks like you reached a conclusion

5 of 244 patients for a total budget amount of $13.7

6 million; is that correct?

7 A. Correct.

8 Q. And you say the current budget is $10.2. Had

9 you gotten to $13.7?

10 A. No, we're on target -- again, we've done 123.

11 We're on target to do the other 120 by the end of this

12 fiscal year with the expectation that we would have

13 spent around that much money depending on how the exact

14 dollars come out. No one has told me not to spend more

15 than that.

16 Q. Okay.

17

I want to go up to the top of this

18 document where it's been crossed out where it says that

19 given AASLD states "the most efficient approach to

20 fibrosis assessment is to combine direct biomarkers,

21 that is, APRI and vibration controlled transient liver

22 elastography."

23

That's the recommendation from AASLD,

24 right?

Page 116

1 Q. I asked you about the organization National

2 Viral Hepatitis Roundtable and I think you said you

3 didn't have any familiarity with them; is that correct?

4 A. That is correct.

5 Q. Okay.

6

This is a document from them. It's a

7 national organization dealing with hepatitis. And I

8 want to refer to two of the bullet points that are on

9 that document. Obviously, it's a document that says

10 all patients living with Hepatitis C need access to

11 effective treatment. And then there's a bullet point

12 that says watchful waiting can harm patients and

13 there's a reference to the fact that at least they say

14 that Hepatitis C has been linked to many causes of

15 death such as cancer and kidney problems. Delaying

16 treatment for patients until they develop advanced

17 liver diseases means that painful and costly conditions

18 such as liver cancer and/or the need for liver

19 transplant is not avoided which is a highly ineffective

20 use of new curative treatments. They say in addition,

21 Hepatitis C patients whose providers recommend

22 deferring treatment in favor of watchful waiting have

23 been found to be at a high risk for anxiety, illness

24 uncertainty, depressive symptoms regardless of fibrosis

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Page 117

1 stage. And that patients who are cured of Hepatitis

2 C recorded tremendous improvement in their mental

3 well-being. And they reference in that bullet point 6

4 different footnotes with supporting studies. And my

5 question first is whether you agree with their

6 statement as to watchful waiting. And if you don't

7 agree in what respects don't you agree?

8 A. Well, I do not agree only because I've never

9 seen it put together in such a format and

10 broad-sweeping all conclusive statement as that.

11 Q. Okay.

12

And in connection with that if you

13 would look at the sources that they cite, very small I

14 understand, which are footnotes 1 through 6. And my

15 question is only whether you have read or referenced

16 any of those sources?

17 A. No.

18 Q. Okay.

19

And do you know of any studies, trials

20 that would rebut the statement here about watchful

21 waiting?

22 A. No.

23 Q. Okay.

24

Same question as to the next bullet

Page 119

1 Q. This is a document P-10 which you will see by

2 the end Doctor Daniel Dewsnup who actually is a

3 physician with the Oregon Department of Corrections.

4 And it's a piece that he wrote concerning Hep C

5 guidelines and what kind of treatment should be given.

6 I want to refer you specifically to the third page.

7 They're not numbered, but the third page. And we've

8 gone over this before. I just want to zero in on it.

9 Where he's talking about new directions in evaluation

10 and staging of HCV patients. He makes reference to the

11 use of the APRI score and he says use of an APRI score

12 such as a single APRI of more than 2.0 recommended by

13 guidelines to recognize cirrhosis as the only screening

14 test to recognize patients with advanced fibrosis has a

15 very low sensitivity. He says between 36 and 46

16 percent. That would leave 54 to 64 percent of patients

17 with cirrhosis unrecognized until they present with

18 complications of compensated or uncompensated

19 cirrhosis.

20

Do you agree or disagree with that

21 assertion?

22 A. It doesn't seem relevant to our numbers we're

23 using because we go lower than that. Yes, that seems

24 to be a consistent statement with the percentage I

Page 118

1 point which says between 40 and 74 percent of Hepatitis

2 C patients develop at least one extra hepatic, that is,

3 nonliver multiorgan condition. And 17 to 37 percent of

4 all people living with Hepatitis C suffer from

5 Hepatitis C associated heart disease. It goes on to

6 make other statements about the conditions and the

7 symptoms that Hepatitis C patients suffer from. Cites

8 again to another study footnote 7. First question is

9 whether you agree or disagree with the specific factual

10 allegations?

11 A. I disagree in the sense I've heard some of

12 these general numbers related to cirrhosis. I've never

13 seen these kinds of facts put together in the

14 wide-sweeping everybody with Hepatitis C.

15 Q. And the specific footnote reference I assume

16 you have not read that or don't know that particular

17 publication?

18 A. I do not know it, correct.

19 Q. Okay.

20

- - -

21

(Whereupon, P-10 was marked for

22 identification.)

23

- - -

24 BY MR. RUDOVSKY:

Page 120

1 know.

2 Q. Okay.

3

If you go to the previous page, the top

4 with the heading we don't know if treating

5 non-progressors to SVR will reduce their mortality

6 rate. And in the last sentence he says thus, although

7 the benefit for prevention of both hepatic and

8 nonhepatic disease related mortality for that patient

9 group is clear, the mortality benefit for patients with

10 non-progressive HCV infection is unproven as yet.

11

Do you agree or disagree with that

12 statement?

13 A. I've never seen that statement. I don't have

14 enough knowledge to answer that question.

15 Q. Okay, all right.

16

- - -

17

(Whereupon, P-11 was marked for

18 identification.)

19

- - -

20 BY MR. RUDOVSKY:

21 Q. I've given you what's been marked as P-11 and

22 I believe that's the current protocol for the

23 Department of Corrections; is that correct?

24 A. That's correct.

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Page 121

1 Q. And I think you said that was approved and

2 implemented as of around November of 2016?

3 A. Correct.

4 Q. And in the draft and approval process

5 Secretary Wetzel had to sign off on this protocol; is

6 that correct?

7 A. Correct.

8 Q. And he did?

9 A. Correct.

10 Q. Okay.

11 A. To the best of my knowledge.

12 Q. Right.

13

Okay, I want to go through this

14 protocol with you. In the introduction -- by the way,

15 was most of the draft in this protocol done by you?

16 A. I don't know what most means. I'm the one

17 that finally signs off on it. It was a collaborative

18 of a number of individuals. I'm not sure what most of

19 it is.

20 Q. That's poorly phrased. Who else was involved

21 in the actual drafting?

22 A. Doctor Cowan and some of this is taken from

23 the interim so it's an update of the interim.

24 Q. Okay.

Page 123
1 annually will develop HCC which is the cancer. So he 2 says 10 to 20 years. The Hepatitis C protocol, first 3 page, 20-1, says -- why did you use the term 20 to 40 4 years; where does that come from? 5 A. Two things, are you on the third page -6 you're on Page 201, Line 19; is that what you're 7 looking at? 8 Q. No, I'm looking at Page 199, Line 21. 9 A. I would refer you to Page 201 which just 10 jumped out as I was going through. 11 Q. Right. 12 A. Line 19 says 10 to 20 years at least. And 13 that would partially frame my reference is that I don't 14 think anybody really has a good number. It's a huge 15 amount of time in general. And more specific in mine, 16 I believe, I took that out of the introduction to the 17 Veteran's Administration protocol. 18 Q. But if you got a group of persons who got 19 chronic Hepatitis C even at its early stage based on 20 what you read there it might take 10 years, it might 21 take 20 years, it might take 30 years, it might take 40 22 years before you develop to cirrhosis if you do? 23 A. My number would be 20 to 40. His is 10 to 20. 24 Q. All right.

Page 122

1 A. So Doctor Rieger, Doctor Sharff, Doctor Cowan

2 in the updated one. They had most input. There were

3 other physicians that have much less.

4 Q. Okay.

5

With respect to the introduction the

6 assertion is made that HCV is a slowly progressive

7 disease usually requiring more than 20 to 40 years to

8 progress to cirrhosis. I just have a question about

9 that. I've seen a lot of data saying it's 10 to 20

10 years. And let me ask you with reference to Doctor

11 Cowan --

12

- - -

13

(Whereupon, P-12 was marked for

14 identification.)

15

- - -

16 BY MR. RUDOVSKY:

17 Q. We already had part of Doctor Cowan's

18 testimony from the Abu-Jamal case marked. This is

19 another section of that testimony pages 199 through

20 201. At Page 199 he testifies that of those people

21 that develop chronic hepatitis some 20 to 30 percent of

22 those patients will then go on to develop cirrhosis

23 over the next 10 to 20 years. He then says of those

24 who develop cirrhosis 2 to 7 percent of patients

Page 124

1 A. A long time. I wouldn't want to have a case

2 come up and say well, this one's 10, not 20.

3 Q. Right.

4 A. It's a really long time. The difficulty being

5 you very rarely know the time zero.

6 Q. Okay, I understand that. And you don't also

7 know of that group, you're looking at 100 people,

8 right, which ones are going to progress quickly and

9 which ones won't?

10 A. Correct.

11 Q. Okay.

12

You then state in the introduction --

13 when I say you I'm talking about whoever drafted this.

14 Before a patient develops cirrhosis the short-term risk

15 of a liver related complication is low. Low but not 0

16 for one thing; is that correct?

17 A. Correct.

18 Q. And if you're -- you say before a patient

19 develops cirrhosis if you're at F3 and on the border of

20 F4 isn't it true that the short-term risk is very high?

21 A. Well, again, I'm pretty sure I took this out

22 of the Veteran's Administration. I mean, I did sign

23 off on it. But I believe this was used by that and I

24 could see where low may not be the best word to use

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Page 125

1 there and I'm not sure high would be the best word. I

2 think a lot of that still is unknown. Short-term risk

3 can mean, you know, in the next few months. And if

4 they are -- if they don't cirrhosis serious

5 complications in the next few months is low risk.

6 Q. Okay.

7

On the other side of that coin if

8 you're let's just say F1 and F2, you could be sick,

9 right, you could have fatigue, you could have other

10 symptoms. You could be suffering conditions that

11 normal people without Hep C don't suffer from; isn't

12 that correct?

13 A. I'm not sure about the adjectives, but you

14 could have a symptom of fatigue with Hepatitis C at any

15 stage.

16 Q. Okay.

17

The next section is B, screening. I

18 believe we covered that with respect to how long it's

19 been since the DOC started screening incoming inmates

20 and it's your belief that they're going to go back and

21 screen everybody who is currently in the DOC?

22 A. Correct.

23 Q. So my next question now is on section C on the

24 next page where they refer to the tracking spreadsheet.

Page 127

1 current Hepatitis C tracking spreadsheet in Excel

2 format. This spreadsheet will be forwarded to the

3 Bureau of Health Care Services Infection Control

4 Coordinator on a monthly basis. But I think what

5 you've given us is a more selected part of that or...

6

- - -

7

(Whereupon, a brief discussion was held

8 off the record.)

9

- - -

10 BY MR. RUDOVSKY:

11 Q. And this is a spreadsheet as the protocol says

12 for everybody in the DOC with a positive HCV antibody

13 test?

14 A. Correct.

15 Q. So that will include even people -- inmates

16 without chronic Hep C?

17 A. Correct.

18 Q. Because we've had some small 10, 15 percent

19 who may be infected but don't have chronic Hep C; is

20 that right?

21 A. Actually, it's more like 25 percent, 27

22 percent.

23 Q. Okay.

24

And is there a place on this

Page 126

1 And let me mark that as the next document.

2

- - -

3

(Whereupon, P-13 was marked for

4 identification.)

5

- - -

6 BY MR. RUDOVSKY:

7 Q. You've been handed a document, P-13, which is

8 a document that was provided to us in discovery. Based

9 on review of that document can you tell me what that

10 is?

11 A. This is a tracking sheet that we have for all

12 patients in the DOC. I can't tell by the size of this

13 if this is everybody with Hep C or -- it looks like

14 everybody who has been referred to the Hepatitis C

15 Committee.

16 Q. It looks like you got some like 400 people

17 listed here. I did a quick eyeballing; does that sound

18 about right?

19 A. Correct, they're the ones that have been

20 referred to the committee.

21 Q. Okay.

22

Because what we asked for -- I mean,

23 under the protocol it says for all patients with a

24 positive HCV antibody test the ICN will maintain a

Page 128

1 spreadsheet to record the fibrosis stage number?

2 A. This is what Mr. Wenhold does. Let me take a

3 look here.

4 Q. It was unclear to me whether that's even

5 noted.

6

MR. GOODMAN: Are you referring to this

7 spreadsheet or the spreadsheet that hasn't been

8 produced?

9

MR. RUDOVSKY: The only difference in

10 the spreadsheets is whose on them. But I'm now

11 referring just to this document, that's fair.

12

MR. GOODMAN: Okay.

13

THE WITNESS: Right here, about

14 two-thirds of the way down. It says fibrosis score.

15 BY MR. RUDOVSKY:

16 Q. But I don't -- except for a few entries of 4's

17 as I look through this document the only entries I see

18 is 4's and three's one 3, a few more 3's. So we just

19 got some 4's and 3's entered.

20 A. Correct.

21 Q. So my question is why is that? Isn't this

22 tracking sheet aren't you trying to track from F0 to

23 F4?

24 A. Correct, so the ones that have an actual F

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1 score can only achieve an actual F score through

2 elastography. So those are ones who have had

3 elastography done during our protocol.

4 Q. Okay.

5

And as a predicate to elastography how

6 do you select from this group of 7,000 or so who should

7 get elastography?

8 A. APRI between 1.5 and 2 and platelet count less

9 than 100,000.

10 Q. Both or one?

11 A. One, I'm sorry.

12 Q. Okay.

13

And going back again to this APRI

14 score, right, which we know is between 1.5 and 2?

15 A. Because we treat everybody above 2 without

16 testing.

17 Q. But if you're in that 1.5 to 2 that's only 48

18 percent accurate; is that correct?

19 A. Correct.

20 Q. Which means 52 percent could be at a higher

21 score than you're designated at a higher F score?

22 A. Yes.

23 Q. And they're not going to elastography?

24 A. No, because they're being treated without

Page 131
1 Q. But they won't be -- but the APRI score what 2 I'm asking is that if the APRI score is inaccurate, 3 it's only 50 percent. It only captures 50 percent of 4 the population aren't you missing a significant number 5 of people who won't go to elastography? 6 A. If you're above 2.0, you're off the APRI score 7 equation, you're treated. Are we clear on that? 8 Q. Right. 9 A. There's nobody being missed above 2.0. 10 Q. I understand that. 11 A. All being treated, okay. So now we're going 12 deeper down in which is all about prioritization. We 13 have now taken APRI greater than 2.0 off the equation. 14 We now go deeper into the protocol. The next level is 15 2.0 to 1.5, okay. Do they all have cirrhosis, probably 16 not, but now these are sensitivities. But what they do 17 now is we take them to elastography. Elastography says 18 F4 or F3 they are treated. If the elastography says 19 they are 2, 0 or 1 they go back on low priority. 20 Q. And your testimony is that everybody in the 21 system with 1.5 or higher is either automatically going 22 on to other treatment because they're above 2.0 or has 23 had elastography if they're between 1.5 and 2.0, 24 everybody in the system?

Page 130

1 elastography.

2 Q. I'm sorry, they're --

3 A. They are being treated without elastography.

4

I'll rephrase that.

5 Q. Go ahead.

6 A. If a patient has an APRI score of 2 or greater

7 which indicates more severe disease, we are not doing

8 elastography. We are going directly to treating all of

9 them.

10 Q. Everybody 2.0 and above is now getting DAA's?

11 A. That is correct.

12 Q. Okay.

13 A. If they're 1.52, again, it's the APRI starts

14 losing its sensitivity we're sending them to

15 elastography to make the determination of their F4, F3,

16 F2.

17 Q. So everybody 1.5 and above is being sent --

18 1.5 to 2.0 is being sent for elastography?

19 A. Correct.

20 Q. But I'm now asking the final question there is

21 in the 1.5 to 2.0 range there's a roughly 50 percent

22 chance of missing somebody who is actually at a more

23 advanced stage; isn't that true?

24 A. I'll take them to elastography and I'll know.

Page 132
1 A. They're not all complete yet. This is part of 2 what we were doing currently. And we are -- as I 3 mentioned before, we've treated 120. The goal is to 4 treat 120 more this fiscal year ending in June. We are 5 on target for scheduling -- identifying and scheduling 6 those that need to go to elastography. They all 7 haven't gone. There are some going in February, some 8 going in March, some going in April. And we'll 9 continue identifying some. But the plan is to get them 10 all to elastography and identified as either F4, F3 to 11 treatment, F2 and lower can wait. 12 Q. Do you have good data on how many inmates are 13 either 1.5 to 2.0 APRI score level? 14 A. Yes, not with me but we have exact data. 15 Q. Can you give me an estimate of how many? 16 A. No, I have too many numbers in my head, sorry. 17 Q. Can you give me an estimate of how many of 18 those have actually gone to elastography? 19 A. Everyone that's got a number on here. 20 Q. Okay. 21 A. So there's approximately probably less than 22 100. 23 Q. Okay. 24 A. I don't know that number. The number can be

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1 derived by looking at the data on there. 2 Q. Does this document include everybody 1.5 or 3 higher? 4 A. Yes, well, generally. 5 Q. Okay. 6 A. There's somebody hiding out there that we 7 missed. 8 Q. I understand. 9 A. There's a tab that has everybody, okay. So 10 the job of the ICN, Richard Wenhold, is to take those 11 in an Excel, sort out by labs and pull everybody with 12 1.5 out, create this and we evaluate them to see where 13 they are in the protocol. 14 Q. And as you say the way we know from this 15 document whether somebody has been evaluated beyond the 16 APRI score is whether there is a fibrosis score 17 entered? 18 A. That means they've had elastography in our 19 system under this protocol. 20 Q. And if they don't they haven't had the 21 elastography yet? 22 A. Someone could have had elastography in the 23 civilian world and come in and it may not have made it 24 on here. It's sort of set up for at the end of the

Page 135

1 you just testified to. Is the meaning of this

2 provision that an inmate/patient has to advance to the

3 cirrhosis stage before they will get DAA treatment?

4 A. Well, you're saying that backwards.

5 Q. Okay, correct me.

6 A. The correct way to say that is that everybody

7 we find with cirrhosis gets treatment immediately,

8 immediately.

9 Q. And this is your section that deals with how

10 to identify those with cirrhosis?

11 A. This is an educational piece to help the

12 clinicians in the field identify those that we know or

13 have a high probability -- they have a high enough

14 probability of cirrhosis that they don't need to

15 proceed onto further evaluations. That they are

16 immediately going to go to treatment.

17 Q. Okay.

18

On the next page, subsection 3 of D

19 which refers to abdominal imaging studies such as

20 ultrasound. What's the meaning of that provision and

21 when is it used?

22 A. This was used in case a patient had had one of

23 these tests done outside of the official protocol but

24 had it on their medical chart that we would take that

Page 134

Page 136

1 month we get our elastography reports, you pull this

1 into consideration of possibly making the diagnosis of

2 up, you feed them in. Everybody who has had

2 cirrhosis without having done something like biopsy or

3 elastography under our protocol that started in October

3 elastography.

4 is entered in here. I just signed off a dozen more 2

4 Q. Okay.

5 days ago that aren't on here.

5

Let's go to section E, assessing

6 Q. Okay.

6 hepatic compensation. And it refers to the

7

Aside from elastography the AASLD

7 significance of hepatic compensation in determining the

8 recommended combining that with direct biomarkers.

8 most appropriate treatment regimen and refers to a CTP

9 What's the meaning of that?

9 score as a useful tool to help determine the severity

10 A. It said it was more efficient. I don't know

10 of cirrhosis and to distinguish between compensated and

11 that it said recommended unless you take me back to

11 decompensated liver disease in patients with known or

12 that document.

12 suspected cirrhosis; is that correct?

13 Q. Okay.

13 A. That is correct.

14 A. It did say it's more effective.

14 Q. Okay.

15 Q. And what are direct biomarkers?

15

There's then a chart which lists CTP

16 A. They're more sophisticated blood tests of

16 score and indicating whether there's compensated

17 which I don't have a lot of knowledge about. I've had

17 cirrhosis or decompensated cirrhosis. If one has

18 very little knowledge about. We don't utilize them.

18 decompensated cirrhosis will they be treated with DAA's

19 Q. So you're relying basically on the

19 under this protocol?

20 elastography test combined with the APRI score?

20 A. They will be referred to Doctor Cowan to see

21 A. Yes.

21 if it would be appropriate as a hepatologist to treat.

22 Q. Okay, all right.

22 Decompensated cirrhosis can include those that are on

23

I'm going to section D on Page 20-2

23 death's doorstep, it can. The first last thing you

24 which refers to diagnosing cirrhosis. This covers what 24 have before you die is decompensated cirrhosis. That

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1 patient would not be appropriate to treat. Backing up,

2 you are not excluded for treatment for being

3 decompensated, okay. You are sent to a hepatologist

4 for final evaluation of what medication regimen is

5 appropriate or if not.

6 Q. And to use someone who has reached that stage

7 and it may just be too late, right, as you say with

8 decompensated you may be on death's door. If that

9 person had been treated at F1 or F2 they would have

10 never reached decompensated cirrhosis; is that correct?

11 A. I don't know enough to answer that question.

12 Q. Let me put it this way, if the cure rate with

13 Harvoni is over 90 percent and you're at F2 then you've

14 got a 90 percent chance of never going to cirrhosis; is

15 that correct?

16 A. Restate that, please.

17 Q. If the Harvoni cure rate is 90 or 90+ percent

18 for all persons with HCV, if you're treated at F0, F1

19 or F2 you've got a 90+ percent greater chance of never

20 going to cirrhosis; isn't that correct?

21 A. If that cirrhosis was 100 percent caused by

22 Hepatitis C.

23 Q. Okay.

24

Let's talk about compensated cirrhosis.

Page 139
1 missing here? 2 Q. I'm looking at what you're looking at which is 3 the table. And you break down cirrhosis between 4 compensated and decompensated. I understand on the 5 decompensated you may have reached the stage where it's 6 too late to even use these drugs, it's not going to 7 help; is that correct? 8 A. Correct. 9 Q. So I'm now focusing on the compensated 10 cirrhosis, this is F4, right -11 A. That's correct. 12 Q. -- they're in the cirrhosis stage. It's 13 compensated cirrhosis and what I'm asking is why are 14 you dividing the world between these two as to who gets 15 treated and who doesn't? 16 A. I'm asking you, sir, where you see in here 17 that they are not treated? 18 Q. Well, let me get -- we'll do that when we get 19 to the priority stages, okay, maybe that's where the 20 answer is in this document. Let's hold off on that. 21 A. Okay. 22 Q. I want to go to section F, additional 23 interventions for inmates with cirrhosis. And I want 24 to go to F2 which is the top of 20-4 which talks about

Page 138

Page 140

1 That's still cirrhosis, compensated cirrhosis; is that

1 HCC screening?

2 correct?

2 A. Yes.

3 A. Correct.

3 Q. Liver ultrasound is recommended every 6 months

4 Q. Kind of a less serious stage?

4 for patients with both cirrhosis and chronic HCV

5 A. Correct.

5 infection. Is that actually being done at the DOC?

6 Q. I take it under this formulation in your

6 A. Every patient with cirrhosis, yes.

7 protocol if you are only diagnosed with compensated as

7 Q. But it says both cirrhosis and chronic HCV

8 opposed to decompensated cirrhosis you won't

8 infection. Is that others who don't have cirrhosis but

9 automatically get DAA treatment?

9 have chronic HCV infection?

10 A. That's an incorrect statement.

10 A. No, it's just the ones with cirrhosis. I'm

11 Q. How would you state it then?

11 not sure of the wording on that.

12 A. I would say any and all patients who have a

12 Q. If you're at F3 will you be getting -- this is

13 diagnosis of cirrhosis are at the top of the list and

13 cancer. HCV refers to liver cancer; is that correct?

14 are immediately treated.

14 A. Correct.

15 Q. Then why is the protocol distinguished between

15 Q. And we've seen other references in other

16 these groups and talk about the CTP score as a

16 documents that talk about monitoring at F3 at least in

17 significant factor in who gets treated and who doesn't

17 other systems. And my question is whether the DOC

18 get treated?

18 monitors for HCC if somebody is at F3?

19 A. It's a significant factor of what they're

19 A. No.

20 treated with.

20 Q. Not until you're at F4 cirrhosis?

21 Q. When you say what they're with what do you

21 A. Correct.

22 mean?

22 Q. Now, maybe this refers back to the question I

23 A. What regimen of medications.

23 asked you before on number 3 screening for esophageal

24

Is there a particular line that I'm

24 and gastric varices by EGD is recommended for patients

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Page 143

1 diagnosed with cirrhosis. Now, if everybody with

1 seen in the literature.

2 cirrhosis is being treated with DAA's why would you

2 Q. When will you begin to see jaundice in a

3 have to have this additional screening?

3 patient, could you see it at F2 or F3?

4 A. Because you can treat the varices.

4 A. No.

5 Q. And how would you treat them differently than

5 Q. Not until F4?

6 from the DAA's?

6 A. Maybe late F3. It's a continuum. So I've

7 A. You physically ban them.

7 never seen jaundice except in either cirrhosis -- the

8 Q. So it's not a requirement to get the DAA's

8 very latest of F3 and in 2 months they're going to be

9 that you actually have these varices?

9 -- there's a continuum there. So I don't think it's

10 A. Correct.

10 correct to be using hard and fast numbers. But

11 Q. Okay.

11 basically the jaundice is not in early disease. The

12

I want to now move to subsection G, the

12 jaundice is in late disease. And if you want to split

13 chronic care clinic. What is the chronic care clinic?

13 exactly which F it clicks into I'm not knowledgeable

14 A. It's a tracking system. All our patients who

14 enough to tell you that.

15 have been identified with a chronic medical condition, 15 Q. Okay.

16 hypertension, diabetes, seizure, asthma are put into a

16 A. I will tell you that jaundice correlates with

17 computer system where they're brought up periodically 17 blood tests where as fatigue does not.

18 and evaluated just for that specific disease entity

18 Q. I want to go to H, evaluation for treatment

19 just in the long-term management of their disease.

19 with the antiviral medication. I want to go to number

20 Q. Okay.

20 2, determining whether PA DOC priority criteria for

21

And then on Page 20-5 are a number of

21 treatment are met is an important part of the initial

22 factors or conditions that would be documented in the

22 evaluation and ongoing management of inmates with

23 progress note with respect to persons with chronic

23 chronic HCV infection. Although all patients with

24 Hepatitis C. And my question is this, if you look both

24 chronic HCV infection may benefit from patient certain

Page 142

1 at the subjective and objective factors are there

2 conditions here that could exist at F1 and F2 when you

3 look at this list are there conditions here that could

4 affect somebody who you've determined is at F1 or F2?

5 A. No, not that I have personal knowledge of.

6 Q. What if a person is with fatigue?

7 A. Fatigue wasn't on the list.

8 Q. But I'm asking separately if somebody has

9 severe fatigue could they be at F1 or F2?

10 A. Yes.

11 Q. Okay.

12

What other -- let me phrase it this

13 way. At F1 or F2 what other abnormalities have you

14 seen or read about in the literature and it may be very

15 rare, but it may not be, aside from fatigue in terms of

16 mental depression, in terms of other pain and

17 suffering, extra hepatic conditions, what's possible at

18 those stages?

19 A. The depression one I read somewhat about, but

20 in our system our patients are followed by a mental

21 health team outside of the medical evaluations. So I

22 don't have a lot of personal knowledge within our

23 system of correlations between depression and Hepatitis

24 C. And those are the two general symptoms that I've

Page 144

1 cases are at a higher risk for complications or disease

2 progression and require more urgent consideration for

3 treatment. That's in the protocol, right?

4 A. Correct.

5 Q. And so it does state, does it not, that every

6 person with chronic HCV which is the 5,500 or so in the

7 DOC would benefit from this treatment?

8 A. Correct.

9 Q. And the AASLD says everybody it's a medical

10 necessity to treat everybody with chronic Hep C?

11 A. I'm not sure they use the word medical

12 necessity. That's a significant word in our world.

13 I'm not sure they used the word medical necessarily.

14 Q. Do you know why they would recommend universal

15 treatment aside from -- with the exclusions we talked

16 about why they would recommend what I'll call universal

17 treatment for everybody with chronic Hep C if it's not

18 necessary or beneficial to that person?

19 A. Beneficial. But medically necessary for

20 everybody to get treated right away, we disagree with

21 that.

22 Q. Okay.

23

But not with the fact that it's

24 beneficial?

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1 A. Correct.

2 Q. And once you get to F3 what are the symptoms

3 you're likely to see in somebody in F3?

4 A. Again, I just answered that. There's early 3

5 and there's late 3. So the symptoms -- the general

6 symptoms of fatigue, yes, that can be there.

7 Depression, I defer to mental health because they

8 address all of that. The primary care physicians do

9 not. My experience is is that it's the F4's that

10 develop the ascites and encephalopathy and esophageal

11 varices and those late state manifestations.

12 Q. Okay.

13

Let's turn to the priority levels

14 starting at 20-7. So the highest priority for

15 treatment priority level 1, known cirrhosis or clinical

16 findings consistent with cirrhosis. And cases of

17 decompensated cirrhosis with a CTP score of 7 or above

18 are the highest priority; is that correct?

19 A. That's what it says, yes.

20 Q. Which would -- so again, distinguishing

21 between decompensated and compensated, right,

22 decompensated is the highest category?

23 A. Correct.

24 Q. Would compensated be within priority level 1?

Page 147

1

And so people at F3 are certainly at a

2 higher risk for HCC than at F2 or F1 or people who

3 don't have any Hep C at all. Which is why, isn't a

4 true, a number of organizations recommend testing for

5 HCC once you're at the fibrosis 3 stage, that would be

6 the rationale?

7 A. I don't know what the rationale is.

8 Q. Okay, all right.

9

Moving on to priority level 3. I'm

10 sorry to level 2 now. Once you're at fibrosis level 3

11 do you know of any data that indicates the likelihood

12 of progressing to 4?

13 A. No.

14 Q. Let me put it this way, is it a higher number

15 than if we look at the group from F0 or F1?

16 A. Yes.

17 Q. So percentage wise as the disease progresses

18 you're more likely to progress to the next level?

19 A. That seems logical, yes.

20 Q. Okay.

21

Priority level 3 which is the stage 2

22 fibrosis indicator. That's a group of patients who are

23 not now receiving DAA's?

24 A. Correct, understanding that that number 2

Page 146

1 A. Yes, under the term cirrhosis.

2 Q. Right, and then where it says patients with an

3 isolated APRI score of 2.0 or more with no other

4 clinical findings of cirrhosis are included in priority

5 level 2?

6 A. Correct.

7 Q. So not automatically treated?

8 A. Correct, and that speaks to the sensitivity of

9 the test alone.

10 Q. Okay.

11

Let me look at subsection 3 under

12 priority level 1 referring to HCC which is liver cancer

13 it states at least one-third of all cases of HCC occur

14 in association with HCV infection. With most cases

15 occurring in those with advanced fibrosis or cirrhosis;

16 is that correct?

17 A. That's what it says, yes.

18 Q. So included in that are individuals at F3; is

19 that correct?

20 A. Again, that's a spectrum.

21 Q. I understand a spectrum.

22 A. But that would be advanced fibrosis is a

23 definition of F3.

24 Q. Okay.

Page 148

1 where it says APRI score of 1.5 to 2.0, if they have

2 1.5 to 2.0 they get elastography. And if it shows that

3 they're an F3 then they're moved up to the next higher

4 level on priority and are, in fact, treated.

5 Q. Right, because that's because we now recognize

6 they're at F3 and they shouldn't be classified at F2.

7

Are individuals at F2 sick?

8 A. Sir, could you define sick for me?

9 Q. They're suffering from an illness. They've

10 got an infectious disease.

11 A. Patients with Hepatitis C they all have

12 infectious disease.

13 Q. And some of them will be suffering some

14 symptoms, manifestations of the disease?

15 A. Some will have symptoms.

16 Q. Okay.

17

Priority level 4 is a stage 0 to 1; is

18 that correct?

19 A. Correct.

20 Q. Okay.

21

You then have a section on what you

22 call other criteria for treatment which look to me to

23 be kind of exclusionary factors, right, that is, you

24 may fit the priority level but we're not going to treat

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1 you for some other reason; is that correct?

2 A. Correct.

3 Q. Okay.

4

Let me just go through a few of these.

5 On F sub number 3, have sufficient time remaining on

6 their sentence to complete a course of treatment. I

7 think you said the treatment courses are either 8 weeks

8 or 12 weeks at this point; is that correct?

9 A. Usually there's some outliners that are

10 longer. But generally, 8 or 12.

11 Q. And we need some time to obviously set them up

12 once you decide DAA's are appropriate --

13 A. Correct.

14 Q. -- it will take perhaps a few weeks to

15 schedule and start the dose; is that right?

16 A. It could take longer than a few weeks.

17 Q. Okay.

18

So what is the DOC policy as to what

19 sufficient time means?

20 A. 6 months.

21 Q. So everybody now who you would decide to

22 provide DAA will get it unless they're going to be out

23 within 6 months?

24 A. Correct.

Page 151
1 conditions, cancer, diabetes, cardiopulmonary 2 conditions which would be contra-indicatory as to 3 DAA's; is that correct? 4 A. Correct. 5 Q. And if that's true and I understand there's a 6 small group of inmates that conform to that category, 7 but you anticipate some. If those men or women had 8 been treated at F1, F2 or F3, you wouldn't have gotten 9 to that stage; is that correct, where the condition was 10 contra-indicatory? 11 A. No, not at all. These are nonliver 12 conditions. It has nothing to do with their Hepatitis 13 C. So if I have a patient in congestive heart failure 14 and his heart disease has nothing to do with his 15 Hepatitis C, he is so sick that to treat him for 16 Hepatitis C would not be the correct medically epical 17 thing to do and we would not treat him. He would be 18 excluded for an unstable medical condition. 19 Q. So take the patient who at F2 has no other of 20 these conditions. We know from F2 to F4 may take 21 several years. If you had treated him at F2 you'd 22 eliminate -- if you get the cure you eliminate the Hep 23 C. If he gets one of these conditions between F2 and 24 FP he's now not going to get treated for the Hep C

Page 150

1 Q. We've talked about this before under 4, life

2 expectancy of more than 18 months. The AASLD

3 recommends 12 months. Why is there a difference on

4 that?

5 A. This is FDOP guidelines.

6 Q. Okay.

7

And then we've also talked about number

8 5, demonstrating a willingness and ability to adhere to

9 a structured treatment regimen which I understand is

10 taking the medication, compliance. And to abstain from

11 high risk activities while incarcerated.

12

Is that provision high risk activities

13 a limitation or exclusion on any other medical

14 treatment in the DOC?

15 A. No.

16 Q. I want to go down to 6 now which you call

17 exclusionary indications. First, as to medical

18 exclusions and we've talked about this before. The

19 unstable medical condition that is somebody whose got

20 another medical problem, right?

21 A. Correct.

22 Q. So if I understand this correctly, things have

23 become so complicated that when you're looking at

24 somebody for DAA treatment they have other diseases or

Page 152
1 condition; is that correct? 2 A. Correct. 3 Q. I think you said 6 months on the current 4 incarceration but under B1 it says 12 months? 5 A. The 12 month is on the front end. The 6 month 6 is on the release. 7 Q. Current incarceration less than 12 months? 8 A. In other words, new arrivals don't immediately 9 get treated. 10 Q. But a new arrival at F4 where you would 11 normally treat him why would you treat that person 12 differently than somebody who has been there a year or 13 two? 14 A. The main reason is because a lot of liver 15 disease that comes into our system normalizes and the 16 liver regenerates just by the mere fact that they're 17 not doing drugs and drinking alcohol. So the liver has 18 a capacity to regenerate. And so by just allowing them 19 to have forced abstinence over a period of time often 20 starts them on the road to recovery without having any 21 kind of treatment. 22 Q. And would that be true of someone who comes in 23 at F4? 24 A. They would be referred to us on a one-on-one

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1 basis. And if they were going to be here long enough

2 and it was a significant one we would -- these are the

3 kind of cases that come to the committee that Doctor

4 Cowan and I would discuss.

5 Q. Okay.

6

I want to talk a little bit about the

7 Hepatitis C Committee, all right, which is on Page

8 20-10. You already testified that it's currently you

9 and Mr. Wenhold on the committee, right?

10 A. That's correct.

11 Q. And the one open position would be somebody to

12 be from CCS?

13 A. Correct.

14 Q. A medical person from CCS. And are you now

15 interviewing for that or looking for that position?

16 A. Well, we just -- this has all recently

17 happened in the last 3 months. So we tasked CCS with

18 coming up with someone.

19 Q. Okay.

20

So regardless of who the person is --

21 A. Uh-huh.

22 Q. We've got three positions there. Tell me the

23 responsibilities for each of those three positions?

24 A. Well, the easiest one is the infectious

Page 155
1 somebody else where you're sitting in that committee, 2 the responsibility is what? 3 A. Ultimately, responsible for the overall 4 program, the policy, obviously and making the decisions 5 on the referral forms that come to the committee 6 whether or not they're approved for medications, 7 immediate treatment or whether they can be delayed. 8 Q. So if I get it right, based on the information 9 you receive on all the medical tests that are done 10 whether it's APRI score, elastography or whatever other 11 information you have about that patient, coinfection, I 12 understand there's a lot of things you might want to 13 consider, priority levels and so on. Are you the sole 14 person making the decision that inmate A gets treated 15 as opposed to inmate B and how you prioritize? 16 A. Under the committee the way it's set up or 17 right now. The way it's set up, no, I have the CCS 18 Medical Director. 19 Q. Okay, but I'll get to that in a minute. So 20 tell me what the CCS Medical Director's role is in 21 determining who gets treated as opposed to once we 22 decide they're going to get treated what type of drugs, 23 you know, and what other drugs they might need. But on 24 the decision it's kind of binary, yes or no with DAA's,

Page 154

1 control coordinator. In this case, we talked about

2 Richard Wenhold. His job is administrative, keeping

3 the tracking sheets and keeping the paperwork moving.

4 So the referral forms, he keeps track of them, our

5 signing off on what needs to be done, take them to him

6 and if we need more information he works them with the

7 site to coordinate the decisions of the committee.

8 Q. So he's got no role in determining who will

9 get DAA and who won't?

10 A. That is correct.

11 Q. Kind of a record keeper?

12 A. Exactly.

13 Q. Main responsibility is the spreadsheet?

14 A. Correct.

15 Q. And literally just entering data as opposed to

16 evaluating patients or deciding who should or who

17 should not get treatment?

18 A. Correct.

19 Q. Okay.

20

And that's how that position was

21 envisioned and that's what he does?

22 A. Correct.

23 Q. Okay.

24

And your role whether it's you or

Page 156

1 whose making that decision?

2 A. He and I -- first of all, we go over the cases

3 together.

4 Q. Okay.

5 A. Not separately.

6 Q. Right.

7 A. So we don't go over them and then vote on it.

8 And we come to a common agreement. And generally

9 speaking, if one thinks treatment or one doesn't think

10 treatment unless there's some clinical reason, you

11 know, we generally defer to giving them the treatment

12 if you have to make it. But I have ultimate

13 responsibility. We haven't come across this yet. It's

14 not set up in black and white. But I have ultimate

15 responsibility for the program and I'm the one that

16 signs the paper on whether or not they're approved or

17 not approved. So putting pen to paper, I guess, would

18 have me ultimate. But we have an equal role on the

19 committee.

20 Q. Okay.

21

And then beyond that equal role in kind

22 of determining who should be treated and who shouldn't,

23 I think you referenced the fact that once you decide to

24 treat that person is a medical person who is going to

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Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 41 of 53 Dr. Paul Noel

Page 157

1 do what, what in addition will that person do?

2 A. So what would happen -- and again, it's a

3 little different because the treating physician is on

4 the committee. So let's just say the committee sits

5 down like we are today. We go over a dozen of these.

6 We make some determinations. I sign the form of the

7 determination. The forms that I sign are given to the

8 Infectious Control Coordinator who goes back to his

9 desk, assembles the packet and sends an email to Doctor

10 Cowan as the hepatologist saying the committee, which

11 he is a member, the committee has just approved the

12 following for treatment. Please arrange for

13 medications.

14 Q. Okay.

15

Doctor Cowan has been off the committee

16 for how long?

17 A. I think a few months.

18 Q. So for those several months and until we get

19 the new replacement you're doing both roles?

20 A. Correct.

21 Q. Doctor Noel, if we put aside the security

22 issues you talked about and the administrative issues

23 we've talked about which may limit the number of

24 inmates you can treat with DAA's whether it's security

Page 159
1 is a new landscape on the pure medicine of the whole 2 thing. What are comorbidities, what cause every 3 disease is. This is fast evolving. It may come out 4 somewhere in a few years from now that the F0's are 5 safe. And I think we will address that when it comes. 6 So I think that was -- I answered that too quickly to 7 say that we're going to treat everybody. 8 Q. Based on the current science, based on the 9 current studies, based on what AASLD has recommended, 10 based on the fact that Medicare does it across the 11 board, based on the fact that if you are a private 12 citizen and you have your money and you go to a doctor 13 if somebody came to you at F1 or F0, you're a physician 14 in the community and says, well, I'm at F0, but you 15 know what, I don't want to take the risk. I'll pay for 16 the DAA's, that's my choice. I understand there are no 17 bad side effects, I'll evaluate that. Would you not 18 prescribe the DAA's for that person? 19 A. I haven't wrestled with that question with 20 myself yet. I don't have a good answer for that. 21 Understanding all you said, you know, I would have to 22 sit back and to do an F0. So I think that one -23 Q. Putting aside F0 for a minute, but I'll come 24 back to it.

Page 158

Page 160

1 or transportation or places you can treat them, all

1

F1?

2 those, I give you all of that, right. If you take away

2 A. Yes.

3 that factor and the factor of cost so either of those

3 Q. You would treat?

4 was a barrier to treating 5,500 inmates with the DAA is

4 A. Our goal is to get down to F1 and maybe our

5 there any medical reason you know of why you would not

5 goal would be F0.

6 treat all 5,500 with the D AA's?

6 Q. Okay.

7 A. No.

7

And the fact that as they say Medicare,

8 Q. And why would you treat all 5,500 even though

8 AASLD, Institute for the Study of Liver Disease,

9 some are at F0 or F1 and have a number of them

9 private insurance, I understand we may dispute this

10 literally no symptoms, their daily life is the same as

10 that Medicaid in Pennsylvania is moving to that as

11 if they didn't have Hep C, why would you treat them

11 well, treat everybody regardless of the stage, there

12 with the drug?

12 are negotiations going on. None of that persuades you

13 A. Let me modify my previous answer. I'm not so

13 that that ought to be the patient's choice?

14 sure about an F0. I'm not quite sure about that.

14 A. Well, I'm always careful with the patient's

15 Q. Okay.

15 choice. I mean, for all I know the patient is making

16 A. We haven't got that far down into discussing

16 the choice because what he saw on TV last night. So I

17 this so I'll make that -- but when we're done the plan

17 need to help patients make choices. So I don't want to

18 is when we're done with the F3's and F4's at the end of

18 be pinned in a coroner of treating viremia because I'm

19 this fiscal year which is in months and we start going

19 not smart enough to know that yet. I haven't had to

20 into the F2's the plan is to proceed through the F2's

20 deal with F0. I won't have to deal with F0. So when

21 and on into the F1's. Those that have a normal liver I

21 the time comes I will at which these are very strong

22 think there's still the science is evolving with this.

22 recommendations. I just don't want to go on the record

23 AASLD updates their guidelines like they change things

23 and say my official position is that the DOC is going

24 on a monthly basis. There's articles coming out. This

24 to treat viremia.

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Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 42 of 53 Dr. Paul Noel

Page 161

1 Q. Do you have any sense of the numbers the DOC

2 now F0, F1 and F2, how many fall into each category?

3 A. We have a sense of -- we have an APRI score on

4 everybody.

5 Q. And based on that, obviously, I'm not asking

6 for exact numbers. Because it looks like we got a

7 fairly small cohort of F3 and F4, we got about 400 or

8 so, right?

9 A. Correct.

10 Q. Which leaves another 5,000 plus. Generally,

11 how do you think that breaks down between F0, F1 and

12 F2; do you have any sense of that?

13 A. No, I don't.

14 Q. But you do have -- we can --

15 A. I have the numbers. You asked for the

16 numbers.

17 Q. Okay, okay.

18

By the APRI score --

19 A. Absolutely.

20 Q. -- to the extent the APRI score is a good

21 reflection --

22 A. Correct.

23 Q. -- that that's the best we have; is that

24 right?

Page 163

1

And how many have you treated this year

2 with DAA's?

3 A. We treated 120. And we are on target and have

4 expectations to treat another 120 by the end of this

5 fiscal year which would be the end of June for a total

6 of 240 to 250 for fiscal year 2016-'17.

7 Q. All right.

8

And what are you projecting for the

9 next fiscal year?

10 A. I'm not -- I don't know.

11 Q. Okay.

12

Does that depend in part on budget

13 allocations?

14 A. No, again, we'll sit down and -- fairly soon

15 sit down and determine what it is that we can do, how

16 many can we treat with all the limitations that we

17 have. And then -- and then that will -- and we'll

18 come up with a dollar number based on the cost of

19 medications and request that in the budget.

20 Q. But it's possible even with that you won't get

21 the full budget, I mean, that's a question of

22 negotiations and how much money you're going to get for

23 this particular program; is that correct?

24 A. All I know is I'm going to put in my request

Page 162

1 A. Yes, we have an APRI score on everybody.

2 Q. Okay.

3

MR. RUDOVSKY: Why don't we take 5

4 minutes. I think I'm pretty much done. So let's take

5 a break here. And I think we're on good schedule here,

6 right.

7

- - -

8

(Whereupon, a brief break was taken at

9 this time.)

10

- - -

11

MR. RUDOVSKY: All right, I have a few

12 more questions and then a couple questions on finance

13 and cost.

14 BY MR. RUDOVSKY:

15 Q. Just a point of clarification, when you were

16 talking about having treated about 120 inmates with DAA

17 this year and you're going to go to about 240 next

18 year, was that actual treatment with DAA or those

19 persons who are getting elastography?

20 A. All right, first of all, let's define calendar

21 year. We're talking fiscal year --

22 Q. Right?

23 A. -- 2016-2017 at which we are halfway through.

24 Q. Right, July through June.

Page 164

1 for the budget.

2 Q. And it will be based on your physical capacity

3 to treat?

4 A. And tied in with our goal to get all of the

5 F4's and the F3's completed.

6 Q. Okay.

7 A. But our driving force is just how many we can

8 physically do with security and organization and

9 staffing and all the resources.

10 Q. Okay.

11

Doctor Cowan, no longer the Hep C

12 committee, still with CCS in what capacity?

13 A. He has twofold. One is the State Medical

14 Director which has overall responsibility for all the

15 medical care. But since he is a hepatologist he also

16 now directs and supervises the actual treatment with

17 medications.

18 Q. Okay.

19

Let me go back to the APRI score and

20 ask one other question which I didn't ask. If someone

21 has an APRI score that you measure between 1.0 and 1.5,

22 what's the error rate that they may actually be a

23 higher level than that would translate into on the F

24 score?

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Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 43 of 53 Dr. Paul Noel

Page 165
1 A. I don't know exactly. There's some data 2 around on the sensitivity and specificity within that 3 small -- it may even be in some of the documents we 4 have. 5 Q. Okay. 6 A. But I don't recall off the top of my head. 7 Q. But there is some percentage where you're 8 recording less than 1.5 and, therefore, not referring 9 to elastography who actually are sicker than that 10 measure actually indicates? 11 A. Further advanced in the disease, correct. 12 Q. Okay. 13 A. That is correct. 14 Q. Okay, all right. 15 A. Realizing again, that we will have done 16 everybody down to 1.5 this fiscal year. Realizing 17 because of that we will done everybody fiscal year 18 '16-'17 we will have looked at everybody down to 1.5. 19 So the case that you're making of someone less than 1.5 20 may actually be a little bit further along. They're 21 going to be picked up actually in the next fiscal year. 22 Q. So you're saying by the next fiscal year, not 23 this fiscal year, but the next fiscal year you will 24 have reviewed everybody 1.5 and above?

Page 167

1 fiscal year your budget for Hep C treatment is what?

2

MR. RUDOVSKY: Let me have this marked.

3 This might help. I'm not quite sure. It was given to

4 us in discovery, but let me have this marked as the

5 next exhibit. I don't want you guessing. It's not a

6 trick here.

7

- - -

8

(Whereupon, P-14 was marked for

9 identification.)

10

- - -

11

THE WITNESS: This does not help. This

12 is amount spent, not budgeted.

13 BY MR. RUDOVSKY:

14 Q. All right, let's use this for a moment. So

15 we're currently in -- so looking at last fiscal year,

16 not the current one, '15 to '16, the amount spent was a

17 little more than $3 million; is that correct?

18 A. That's correct.

19 Q. And thus far this year at least through

20 November, 5 months, it's about $2.3 million?

21 A. That's correct.

22 Q. But that's amount spent, not amount budgeted?

23 A. Correct.

24 Q. Okay.

Page 166

1 A. By June 30th, 2017 we will have evaluated

2 everybody with an APRI of 1.5 or higher.

3 Q. And will every one of those have been given an

4 elastography test by then?

5 A. Everyone with an APRI between 1.5 and 2.0 will

6 have elastography. Everybody above 2.0 skips the

7 elastography and goes directly to treatment because of

8 the high likelihood that they do have cirrhosis.

9 Q. Right.

10

And either because they are above 2.0

11 or because the elastography test indicates the need for

12 treatment unless there's an exclusion in this fiscal

13 year every one of those patients will be on DAA's?

14 A. Correct.

15 Q. And those are the numbers you talk about, an

16 additional --

17 A. That's the 240 total.

18 Q. Right.

19 A. And that's our estimate. Again, these are

20 estimates of -- there's not a lot of history in the

21 world of how this works out especially in Corrections.

22 Q. Right.

23 A. That's our best estimate.

24 Q. I may have asked this before, but for this

Page 168

1

MR. MAZESKI: Just for what it's worth,

2 it's in the interrogatories. I think the answer is $14

3 million for the current fiscal year.

4

MR. RUDOVSKY: Budgeted.

5

MR. MAZESKI: Budgeted.

6

- - -

7

(Whereupon, a brief discussion was held

8 off the record.)

9

- - -

10 BY MR. RUDOVSKY:

11 Q. Just referring to the interrogatories for a

12 moment. This was DOC Defendant Noel Answers to

13 Plaintiff's Interrogatories. And I want to read you an

14 interrogatory question and your answer and it's

15 interrogatory number 14. The question was describe in

16 detail all of the factors and reasons other than costs

17 that the Department of Corrections and other defendants

18 relied upon in deciding not to provide DAA to all

19 inmates with chronic Hepatitis C. And state all

20 reasons for not providing DAA to inmates with chronic

21 Hepatitis C. Answer, see exclusions in the DOC

22 Hepatitis C protocol previously provided. That was

23 your answer. Do you recall giving that answer?

24 A. Yes.

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Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 44 of 53 Dr. Paul Noel

Page 169

1 Q. You make no reference here to security. You

2 make no reference here to administrative purposes. And

3 the question was very specific. Other than costs, why

4 would not everybody with chronic Hepatitis C be

5 provided with DAA. You spent a lot of time today

6 giving me a lot of reasons why that doesn't happen, a

7 lot of administrative and security reasons. In your

8 answers to interrogatory you mentioned none of those;

9 is that correct?

10 A. Yes, correct.

11 Q. Okay.

12

You testified that the treatment

13 regimen is about 5,500 for DAA's?

14 A. Right, for a 12 week regimen.

15 Q. Right, that's down from what it started

16 $100,000 or $90,000. And is that part of the fact that

17 you got some negotiating power with the drug companies

18 now by numbers. I mean, how is that system working out

19 because I know that -- I looked at, for example, the DA

20 says they're paying $18,000 a course. Medicare is

21 paying $24,000. I assume that's just huge numbers and

22 therefore, they've got some bargaining power with the

23 drug companies. I mean, what's your sense of what

24 DOC's ability is. I mean, the more people you treat

Page 171

1 Q. I understand the DOC gets a budget from the

2 general assembly each year to run the DOC. Is it up to

3 Secretary Wetzel to decide how much money will be spent

4 on medical care and beyond that how much money will be

5 spent, for example, on Hep C. Who makes that decision

6 in the bureaucracy as to ultimately how much money is

7 going to be spent on this Hep C program?

8 A. I don't have knowledge of the budget process.

9 Q. You just put in the request and hope you get

10 it?

11 A. That's correct.

12 Q. Okay, a couple final questions.

13

In any other chronic disease that you

14 have to deal with at DOC or any other kind of medical

15 condition that requires medical care, can you think of

16 any other category of disease in which treatment

17 decisions are being made today based either on the cost

18 of what could be a good treatment or a cure or what

19 you've talked about as security or administrative

20 reasons for perhaps limiting which patients get which

21 treatment, any other condition that you can think of?

22 A. No.

23

MR. RUDOVSKY: I'm going to turn it

24 over so thank you. We're just going to have some

Page 170

Page 172

1 will the price come down?

1 specific questions now as to Mr. Chimenti.

2 A. I don't know about going ahead. First of all,

2

- - -

3 the Gilead Company is under tremendous pressure from

3

EXAMINATION

4 the entire country to bring their cost down. And they

4

- - -

5 responded to that pressure. And then our medication

5 BY MS. YEH:

6 costs are negotiated by Diamond Pharmacy, our

6 Q. Good afternoon, Doctor Noel.

7 subcontractor for medications. The DOC does not get

7 A. Good afternoon.

8 involved in negotiations. So I don't know exactly how

8 Q. My name is Sue Ming Yeh and I also represent

9 to respond to that. But they negotiate with them and

9 the Plaintiffs in this action. I'm just going to ask

10 have brought the price down also.

10 you a few questions about the specific named Plaintiffs

11 Q. Are you familiar with any studies on cost

11 and more, in particular, Salvatore Chimenti. So the

12 effectiveness of DAA's and let me frame it this way.

12 first question is do you know inmate Sal Chimenti?

13 One way of looking at the world is if you treat

13 A. I'm not sure what you mean by know him

14 everybody at F0, F1, their cured, you don't have to

14 actually. I've never met the gentleman.

15 track them, you don't have to monitor them, you don't

15 Q. Are you familiar with him generally in terms

16 have to test them later, right, you don't have to treat

16 of his name and his medical condition?

17 them at all, right, they're cured. Have you seen any

17 A. Yes.

18 cost effectiveness studies that compare treating

18 Q. And how did you get to know him?

19 everybody early and, therefore, avoiding all the costs

19 A. Through this legal proceedings.

20 that you're going to have for tracking them for the

20 Q. Okay.

21 next 10, 20 or 30 years and then maybe having to treat

21

Did you know him in any capacity

22 them for a more serious disease later. Are you aware

22 through medical treatment at all?

23 of any cost studies in the field?

23 A. No, I've never been involved with his medical

24 A. No.

24 treatment.

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Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 45 of 53 Dr. Paul Noel

Page 173
1 Q. Do you remember making any decisions regarding 2 his medical treatment? 3 A. I believe I became first involved with his 4 medical treatment under the interim protocol and when 5 he was being approved to have the EGD done to see the 6 significance of his disease. I believe I first became 7 involved then. But as I mentioned before, all the 8 final decisions on treatment or not treatment, you 9 know, do come to the committee which I'm on. 10 Q. So even generally, he as an individual with 11 chronic Hepatitis C if he was referred to the committee 12 you would have had some role in making a decision, yes 13 or no, whether to receive DAA's? 14 A. Correct. 15 Q. And in that process do you ever review his 16 medical records? 17 A. Only the referral sheet itself, not the full 18 medical record. 19 Q. And can you tell me more about the referral 20 sheet, how do you get it and who creates this referral 21 sheet? 22 A. It's filled out at the site level. It's 23 filled out by a combination of three people. The 24 Medical Director who is taking care of him, the

Page 175

1 Q. Have you ever received any commentary or

2 recommendations from anyone from the site level

3 regarding individuals with Hepatitis C?

4 A. No.

5 Q. So just some background. I see that you in

6 2012 -- and you testified earlier that from 2012 to

7 2014 you were the Pennsylvania State Medical Director

8 for Wexford?

9 A. Correct.

10 Q. And that was -- at that time Wexford,

11 specifically, was the medical subcontractor for the

12 Pennsylvania Department of Corrections?

13 A. Correct.

14 Q. At that point in time do you know if you were

15 involved in any decision making relating to medical

16 care for people with Hepatitis C?

17 A. Yes, in general, yes.

18 Q. Okay.

19

Can you tell me just what your role was

20 then?

21 A. I believe I was a single point screening

22 before it got referred to the Department of Corrections

23 for treatment.

24 Q. Do you know if you had any involvement in

Page 174
1 Infectious Control Nurse and the Corrections Healthcare 2 Administrator. 3 Q. Of that institution or... 4 A. Yes. 5 Q. Okay. 6 A. At the site level. Everything is filled out 7 at the site level and filled in with laboratory data, 8 test results of any diagnostics, the EGD, elastography, 9 liver biopsies, all the results are put on that. In 10 addition, the screening for sentencing, when he came 11 into the system, when he's expected to be released from 12 the system, any misconducts he might have for tattooing 13 or doing elicit drugs within the institution. Each one 14 has a little bit part of putting that form together and 15 then it's sent up to our office. 16 Q. And typically, do you get any descriptions in 17 that referral sheet? 18 A. What would be a description, give me an 19 example? 20 Q. So are you simply receiving numbers like the 21 lab results kind of what we see in the data tracking 22 sheet or do you get any type of commentary, 23 recommendations from any of these individuals? 24 A. No, this is strictly data.

Page 176

1 making decisions relating to medical care of

2 Mr. Chimenti during that time period?

3 A. I don't recollect.

4 Q. Were you aware at all that Mr. Chimenti was

5 making requests to receive the DAA's starting in late

6 2013?

7 A. I don't remember the timeframe. Late 2013 I

8 would have still been with Wexford. Again, I don't

9 remember. So in January of 2014 I came in to my

10 current position. I really don't remember when he

11 showed up as someone for me to evaluate.

12 Q. Okay.

13

Do you have any role -- when an inmate

14 files a grievance relating to let's say Hepatitis C

15 treatment, and specifically, the DAA's. Do you have

16 any role in responding to those grievances?

17 A. Yes.

18 Q. In late -- why don't you explain what role you

19 have in that?

20 A. In the grievance process?

21 Q. Yes.

22 A. So grievances are filed at the site level.

23 Q. Uh-huh.

24 A. And they are responded to at the site level.

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Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 46 of 53 Dr. Paul Noel

Page 177

1 If the inmate accepts that response it stays at the

2 site level. If the inmate appeals that response it

3 comes up to our central office and it's handled within

4 our office. And at that time depending on exactly what

5 the grievance is we would request parts of the medical

6 record or information from the site in order to address

7 that particular grievance. Myself and in this case the

8 infectious control nurse would review it as a Hep C

9 grievance. We would provide a recommended response and

10 the response is signed off by the Director of the

11 Bureau of Health Care.

12 Q. Okay.

13

If your name isn't -- if you didn't

14 sign the grievance response back to the inmate, would

15 you still -- could you still have had an involvement in

16 making the response to that inmate at the central

17 office level?

18 A. Yes.

19 Q. Okay.

20

So even if your name isn't on it you

21 may have had some involvement in upholding or denying

22 the grievance?

23 A. Yes.

24 Q. How about in your capacity when you were the

Page 179

1 other people are also cc'd as well. So there is a page

2 that's labelled number 2, I don't know if it's actually

3 the second one or not because it's the way I found it

4 was out of order. And there's an email from you

5 stating I agree with having a follow-up EGD on Mr.

6 Chimenti. Will you please have Doctor Kephart order

7 the procedure and explain to Mr. Chimenti that it is

8 part of the workup to determine eligibility for

9 Hepatitis C treatment.

10

First, do you remember if you had prior

11 discussions regarding Mr. Chimenti before this email,

12 these set of emails?

13 A. Prior discussions. It would appear so just by

14 the wording. I agree with following up on EGD. I must

15 have been discussing this with somebody in some format.

16 I don't remember exactly.

17 Q. And was it a common practice for you to email

18 about a particular individual and their -- whether or

19 not they should receive the DAA treatment for Hepatitis

20 C?

21 A. I don't know if it's common. It's not out of

22 the ordinary. If there are questions or something that

23 needs answers or the form has some inconsistencies or

24 something or doesn't make sense or whatever, I usually

Page 178

1 State Medical Director for Wexford did you have any

2 role in responding to grievances then?

3 A. No.

4 Q. For example, Mr. Chimenti filed a grievance

5 back in November of 2014 and he received a response and

6 the Department of Corrections had not yet approved the

7 use of Harvoni would you have been involved in that

8 grievance response?

9 A. Yes.

10 Q. You would have?

11 A. I began in January of 2014. So if you're

12 saying November, 2014 then yes, I would have been.

13 Q. I don't believe it was signed by you, but you

14 would have had some --

15 A. Our policy is that all grievances are signed

16 off on by the Bureau by the Director.

17

- - -

18

(Whereupon, P-15 was marked for

19 identification.)

20

- - -

21 BY MS. YEH:

22 Q. It's a little bit out of order. But these are

23 -- P-15 is a set of emails, a string of emails between

24 you, Dean Rieger, John Kephart and then a number of

Page 180

1 send an email out to confirm something.

2 Q. Okay.

3

So do you know relating to this email

4 if you had at that point in time received a referral

5 sheet about Mr. Chimenti? Can you tell that from the

6 email or out of practice would you know that?

7 A. No, I can't tell by this. I don't know. I

8 don't remember.

9 Q. So if you could turn to what's labelled Page

10 3. It's an email that at the bottom is signed by Dean

11 Rieger. The date isn't on that particular page, but I

12 believe it's dated December 22nd, 2014. Page 2 at the

13 bottom says from Dean Rieger sent Monday, December

14 22nd. And on Page 3 there's the text of that email.

15

So in this case in the second paragraph

16 Doctor Rieger notes, previously, Mr. Chimenti had a

17 liver biopsy demonstrating "probable cirrhosis, Stage

18 4." (5/3/10, presumably May 3rd, 2010.) An ultrasound

19 demonstrating no discreet masses (December 2nd, 2014),

20 and most interestingly 2 EGD's, the first of which

21 demonstrated esophageal varices (October 19th, 2005)

22 and the second of which demonstrated no varices. And

23 then in the next paragraph he says as you know, we are

24 looking at Metavir Stage 4 (cirrhosis as consisting of

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Case 2:15-cv-03333-JP Document 101-11 Filed 11/02/17 Page 47 of 53 Dr. Paul Noel

Page 181

1 several stages.)

2

So at this point in time based on

3 Doctor Rieger's email it was known that Mr. Chimenti

4 had probable cirrhosis stage 4; is that right?

5 A. That's what this email -- probable cirrhosis

6 stage 4, yes, that's what it says.

7 Q. And based on your earlier testimony that would

8 indicate that he was further along in terms of the

9 progression of Hepatitis C; is that right?

10 A. Further long than someone who had an F3 or an

11 F2, yes.

12 Q. Okay.

13

And under your current treatment

14 protocol he would be in the priority category?

15 A. Yes.

16 Q. Okay.

17

Now, this was back in late 2014. At

18 that point in time was the interim protocol in effect?

19 A. No.

20 Q. It was not?

21 A. November of 2015.

22 Q. Can you tell me based -- and going back to

23 your email response what it is that you meant in your

24 email. I agree with the follow-up EGD of Mr. Chimenti.

Page 183
1 single line out of an email is that his was a very 2 complicated medical case with having been treated 3 multiple times unsuccessfully and multiple diagnostics 4 and specialists. And to the best of my recollection we 5 were just trying to sort everything out of where he was 6 in his disease progress at that time. You quote in the 7 email the results of a test done 4 years prior. So I 8 think we were just trying to update what his clinical 9 status was. 10 Q. And through that updating process you knew or 11 would have known that he was at stage 4? 12 A. He was at probable cirrhosis stage 4 on May 13 3rd, 2010. You're asking me where he is on December of 14 2014. As we talked about the science of this is that 15 he may have regressed. He had been treated twice and 16 even though he didn't obtain an SVR he did have a 17 response to the virus. So it could very likely be that 18 he had regressed and no longer had cirrhosis and maybe 19 had advanced fibrosis or whatever. We talked about 20 that. So just to make decisions on something that 21 happened 4 or 5 years ago knowing that things could 22 change, you know, would not be good medicine. 23 Q. So do you remember what happened next? 24 A. Yes, he had the EGD. The results were that he

Page 182
1 Can you please have Doctor Kephart order the procedure 2 and explain to Mr. Chimenti that's part of workup to 3 determine eligibility for Hepatitis C treatment? 4 A. We have not formalized. It had not been 5 released, but we were working on it. So even in the 6 central office as we were dealing on case by case 7 instead of having a whole system responsive to a policy 8 we were still following our patients. We were still 9 getting information from the site on patients. I don't 10 remember where exactly he fits in with that. I don't 11 have the details of that. But this sounds like we were 12 planning on putting the EGD in the policy. And so we 13 were sort of going by those guidelines amongst 14 ourselves. And so that's why I made the statement to 15 tell Mr. Chimenti because there wasn't an actual policy 16 but that's the way we were going with this whole thing. 17 And that we needed that to determine his eligibility. 18 Q. So at that point in time you were aware that 19 there were DAA medications? 20 A. Yes. 21 Q. And based on these emails you would have been 22 aware that Mr. Chimenti was at stage 4 or likely at 23 stage 4? 24 A. All I remember about Mr. Chimenti absent a

Page 184
1 did not have esophageal varices. And so he was put 2 lower down on the list so we could get the ones that 3 did have esophageal varices because it had been 4 determined that those have a higher priority within our 5 cohort that we were trying to immediately treat. 6 Q. And you know, I understand you had testified 7 earlier about your prioritization rationale. Putting 8 that aside, had he received the DAA treatment at that 9 time would it have prevented any further progression of 10 Hepatitis C for him? 11 A. That's individual. I can't comment on 12 Mr. Chimenti's case. 13 Q. But in general, if an individual once they 14 receive DAA's 90 percent of the individuals no longer 15 have Hepatitis C in their system? 16 A. That is correct. 17 Q. So if he received DAA's at that time he would 18 have had a 90 percent chance of eliminating the 19 Hepatitis C virus? 20 A. Correct. 21 Q. And you had stated earlier you had not 22 reviewed his medical records independently? 23 A. Maybe bits and pieces that came through 24 especially when the issue of the mass on his liver came

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Page 185

1 up I was getting parts of his medical record trying to

2 assist with working through that whole issue.

3 Q. Okay.

4

And were you aware that he was

5 reporting fatigue, that he wasn't feeling well, that he

6 was having trouble thinking?

7 A. I don't remember those. They may have been

8 contained in something like the grievance. You asked

9 if I see symptoms. That might come in a grievance but

10 not in a Hepatitis C referral form. So I don't

11 recollect any of that.

12 Q. So when you respond to the grievance do you

13 review them, read them?

14 A. I'm sorry, do I read the grievance?

15 Q. Yes.

16 A. Yes.

17 Q. Okay.

18

So you likely would have read it but

19 you might not have an independent memory of that right

20 now?

21 A. Correct.

22 Q. And so had he received the DAA's at that time

23 it's likely his symptoms in terms of fatigue and not

24 being able to remember things, his feeling ill, would

Page 187
1 to do it the right way. And so at some point in time I 2 don't remember where yes, I became more involved in it. 3 Q. Did you have any decision making role in -- at 4 that point in time whether or not to give him DAA's? 5 A. Yes. 6 Q. And so at that point he did not receive the 7 DAA's, presumably, you had final authority at that 8 point in time to say no, he should not get DAA's right 9 now? 10 A. Correct. 11 Q. And do you recall the reasons why you said no 12 around that time? 13 A. I don't remember the specific details of the 14 case. He did not meet criteria. 15 Q. Had he met the criteria in the treatment 16 protocol would he have received the DAA's? 17 A. Oh, absolutely as he has now that he meets 18 criteria. 19 Q. In terms of the timeframe the mass showed up 20 in the CT scan about October of 2016. And then 21 subsequently at least from Mr. Chimenti's perspective 22 he was informed that he had to undergo a liver biopsy 23 before he could get further treatment or be referred to 24 a hepatologist. Did you have any role in that

Page 186
1 have been alleviated? 2 A. I cannot say that. 3 Q. Is there a chance that he would have -- those 4 symptoms would have been alleviated? 5 A. If they were all directly related to Hepatitis 6 C and he had the virus removed from his body, there's a 7 chance that those symptoms would have been alleviated. 8 Q. You had talked earlier that you were aware 9 that he later had developed a mass in his liver? 10 A. Yes. 11 Q. Do you remember when you became aware of that? 12 A. No. 13 Q. And you talk about your role in that whole 14 process, what was your role, were you being consulted 15 or just kept aware or what was your involvement in 16 that? 17 A. I don't remember exactly where the lawsuit 18 came in or the grievances and the letters from 19 whichever lawyer that was saying he had cancer. When 20 all of that becomes -- you know, it's high visibility 21 now and it was a complicated medical case. It wasn't 22 as easy as some of the other Complainants in here where 23 it's fairly cut and dry as far as our prioritization. 24 This one was a complicated medical case and we wanted

Page 188
1 decision? 2 A. I not only don't have any role in that, I 3 don't recollect that decision and would not 4 substantiate it unless you have something in writing 5 contrary to that. 6 Q. And do you know who -- if that was a decision 7 who would have been the one to make that? 8 A. Which decision? 9 Q. That he needed a liver biopsy? 10 A. Generally speaking, which I think applies to 11 his case is that if you think someone has cancer you 12 get a liver biopsy. And someone was saying he had 13 cancer, some non-medical person. And we had him 14 referred to a specialist who said it's not a cancer, 15 it's a vascular lesion. And if I stick a needle in 16 there there's a high likelihood of a bad outcome. And 17 that's where the conflict came in all of that. So I 18 don't know where along the lines somebody recommended 19 that there be a biopsy. But that was only not 20 performed because another off-site specialist, not one 21 of us, said that that was very dangerous. 22 Q. And at that point in time would it have been 23 appropriate to send him to a hepatologist for review? 24 A. You're assuming he was not sent to a

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Page 189

1 hepatologist.

2 Q. Correct?

3 A. I'm not so sure that Doctor -- I don't know.

4 I'm not so sure -- you're saying Doctor Cowan was not

5 involved in his case?

6 Q. Well, was he? I guess I'm asking you because

7 --

8 A. Well, you would have to show me documentation.

9 Doctor Cowan came onboard in January of 2016.

10 Q. Uh-huh.

11 A. And if the first CT was abnormal in 2015 in

12 October and I don't know -- I don't dispute the dates,

13 but I don't know. It's only logical that he was

14 involved during the year of 2016 with his case. And we

15 would have to look at the record and you can ask Doctor

16 Cowan. But the timeline is consistent with our having

17 a hepatologist onboard to help us. That's all I can

18 say about it.

19 Q. Okay.

20

So whether or not Doctor Cowan is

21 listed in the medical records at that point in time

22 because he was a hepatologist, he would have been

23 referred -- he would have been consulted for

24 Mr. Chimenti's case?

Page 191

1 protocol, and again, the protocol is for the 99 percent

2 he was the 1 percent that fell out of the protocol

3 because of the liver mass. It wasn't a matter of

4 reviewing it per protocol performs. I was kept

5 up-to-date every time there was some type of a decision

6 point that was made or a specialist had seen him or a

7 diagnostic test had come back I would be updated on it.

8 Q. Do you recall having to make any yes or no

9 decisions for him more than once, for example?

10 A. Not necessarily yes and no. I gave feedback.

11 Again, the -- once you come out of the protocol you

12 become a medical -- and he became more a pure medical

13 case than he did a protocol case. And I know that the

14 litigation is around the lawsuit and those things. He

15 became a complicated medical case which means it relies

16 on CCS to make the decisions about his medical care,

17 whether or not he should have a biopsy, not have the

18 biopsy, go to another specialist. I supported going to

19 the transplant center as another opinion to make sure

20 that we were doing everything right for him medically.

21 But the actual decision making and the process of his

22 specific medical care is CCS.

23 Q. Okay.

24

And who would have had the final

Page 190

1 A. Again, I do not remember the details. I can't

2 imagine sitting in my office with having Mr. Chimenti's

3 case in front of me in the year 2016 and having a

4 hepatologist sitting across the hall for whom the

5 doctors work I would give it to him. But I have no

6 recollection or documentation of that happening.

7 Q. Okay.

8

Well, the medical records are a little

9 thin in terms of your name or Doctor Cowan's name so

10 that's why I'm asking you that.

11

Were there any other hepatologists on

12 staff at that time?

13 A. No.

14 Q. You had mentioned earlier that you were aware

15 of the lawsuit and the litigation. And were you aware

16 that we as Mr. Chimenti's lawyers have written a letter

17 on his behalf, obviously, directed to your Counsel, not

18 to you directly, regarding his medical treatment?

19 A. I don't remember exactly.

20 Q. Do you remember if -- how frequently you

21 reviewed Mr. Chimenti's medical case in terms of

22 whether or not to give DAA's?

23 A. Well, because the issue became very

24 complicated medically and no longer really fit into the

Page 192

1 authority on those issues at CCS?

2 A. Doctor Cowan.

3 Q. In March of 2016 Mr. Chimenti had a meeting

4 with various medical staff at SCI Smithfield which

5 included the Medical Director, Doctor Frommer, Doctor

6 DeBellis and other individuals. Were you aware of that

7 at all?

8 A. I don't remember the date. If you gave me the

9 subject matter I might have remembered.

10 Q. Okay, I don't believe you were present. But

11 what happened at the meeting was Mr. Chimenti had an

12 opportunity to speak to the medical staff about his

13 condition. He made a request for the DAA treatment as

14 well as to see a hepatologist or a transplant

15 hepatologist. From his understanding, he was informed

16 that the request would be forwarded on to central

17 office. He was told central office. Did you ever

18 become aware of any type of request like that?

19 A. A request to start the medications?

20 Q. Yes.

21 A. I don't remember that particularly.

22 Q. Okay.

23

He was informed that it was denied. Do

24 you -- would you have had a role if he received

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Page 193
1 information that it was denied? 2 A. Yes. 3 Q. And in terms of the decision to see a 4 hepatologist or a transplant hepatologist would you 5 just to clarify here what role would you have had, if 6 any, in making that decision? 7 A. The formal process of going to off-site 8 specialists is CCS. But because of this particular 9 case I'm sure I was probably asked my opinion, asked 10 for my support which I gave. It wasn't a matter of 11 approval or disapproval. And I'm not in that loop. So 12 technically, I'm out of all of that. But because of 13 this case I am sure they would have asked my support 14 and I did support it, yes. 15 Q. As you know Mr. Rudovsky had earlier gone 16 through the AASLD recommendations that all individuals 17 be treated with the DAA's. As far as you understand 18 with Mr. Chimenti having chronic Hepatitis C would he 19 fit within that recommendation for the AASLD? 20 A. Their recommendation to treat everyone? 21 Q. Yes. 22 A. Actually, even under AASLD guidelines he would 23 not go directly to treatment because there was this 24 question of what this mass is in the liver. And until

Page 195

1 being treated with DAA's?

2 A. Likely, yes.

3 Q. And do you have any independent memory of

4 Daniel Levya at all?

5 A. No, other than reviewing his referral form and

6 not approving it.

7 Q. Okay, that's your only memory of Daniel Levya

8 that you have reviewed his referral form?

9 A. Correct.

10 Q. And do you recall why he was denied?

11 A. Because of his low APRI score.

12 Q. Okay.

13

And again, would he fit within the

14 recommendation of the AASLD to receive the DAA's?

15 A. Yes.

16

MS. YEH: I don't believe I have any

17 other questions but...

18

(Whereupon, a brief discussion was held

19 off the record.)

20

- - -

21

MS. YEH: We don't have any other

22 questions.

23

- - -

24

EXAMINATION

Page 194

1 that is firmly established and agreed upon treatment of

2 DAA's is contraindicated in all of the guidelines.

3 Q. What about before he developed that mass or

4 whatever it is or was, would he have fit within that

5 recommendation that all individuals be treated with

6 DAA's?

7 A. Yes.

8 Q. Okay.

9

I'm just going to ask you a couple of

10 questions about the other two named Plaintiffs.

11

Do you have any independent memory of

12 David Maldonado?

13 A. Minimal.

14 Q. And what is that?

15 A. I reviewed his referral form and disapproved

16 his treatment with medications.

17 Q. And what was the basis for the disapproval?

18 A. A low APRI score.

19 Q. Now, based on the number that you had before

20 you -- and the recommendation by the AASLD would he fit

21 under their recommendation that all individuals be

22 treated?

23 A. Yes.

24 Q. And therefore, he would likely benefit from

Page 196

1

- - -

2 BY MR. MAZESKI:

3 Q. I just have some follow-ups on Levya and

4 Maldonado. And just by way of background, I pulled the

5 numbers for Levya and Maldonado from the most recent

6 tracking sheet. But anyway, so Doctor Noel, in the

7 First Amended Complaint filed by Mr. Chimenti, Levya

8 and Maldonado there's specific sections for each of the

9 three named Plaintiffs. And with respect to Mr. Levya,

10 paragraph 67, he alleges he currently experiences

11 symptoms of Hepatitis C including pain, fatigue and his

12 eyes are jaundice and he required immediate treatment

13 to prevent any further liver damage.

14

So based upon that my first question is

15 in your experience does Hepatitis C cause someone to

16 feel pain?

17 A. Not until the end stage when physically the

18 accumulation of the fluid called ascites in the belly

19 that's when they seem to experience significant amount

20 of pain.

21 Q. And in looking at what I have here as far as

22 the data the numbers of Mr. Levya's most recent test

23 results is there anything to indicate that he's at that

24 end stage where he would feel this pain?

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Page 197
1 A. No. 2 Q. And where Mr. Levya claims he's suffering from 3 fatigue. Is fatigue exclusive to Hepatitis C? 4 A. No. 5 Q. In the medical world based upon your 6 experience and education is there more than one thing 7 that can cause fatigue? 8 A. Not only in the medical world, specifically, 9 within Corrections fatigue is not an uncommon symptom 10 for many diseases. 11 Q. Is there any of these test results that would 12 correlate or give an indications as to whether a 13 patient should have jaundice in the eyes or not for 14 Daniel Levya? 15 A. The most recent blood test here that 16 correlates with jaundice is a Bilirubin 0.5. And you 17 do not see jaundice -- clinical jaundice until a 18 Bilirubin is at least 3.0. So there's no laboratory 19 data that correlates with that. 20 Q. So based upon the laboratory data you see -21 the most recent laboratory data of Mr. Levya does any 22 of that -- is any of that consistent with the symptoms 23 he's alleging in the Complaint or would support the 24 symptoms that's alleged in the Complaint?

Page 199

1 suffering from any liver damage at this point in time?

2 A. His ALT is 14 and AST is 22, both absolutely

3 normal. And his APRI is 0.179, well below our

4 threshold of 1.5 for the current group of patients who

5 were evaluated. And there's no indication that he has

6 irreversible liver damage.

7 Q. Based upon this APRI score is there anything

8 else in these lab results, can you assess -- is it a

9 Metavir score of an F0 through F4 to both of these

10 individuals?

11 A. Only that it's less than an F3.

12

MR. MAZESKI: I have no further

13 questions.

14

- - -

15

EXAMINATION

16

- - -

17 BY MR. RUDOVSKY:

18 Q. Let me just ask a couple questions on

19 follow-up.

20

You said that one would not have

21 substantial pain due to Hep C until very late stages

22 when the fluid builds up and so on. But isn't it true

23 people could have pain at F3 and F2, fatigue, related

24 to other conditions that they have, extrahepatic

Page 198
1 A. No. 2 Q. Mr. Maldonado in Paragraph 76 of the Complaint 3 says Maldonado suffers from elevated liver enzyme 4 levels beyond the normal range. In these lab test 5 results for Maldonado is there anything in there that 6 relates to liver enzyme levels? 7 A. When the term liver enzymes are used generally 8 they're referring to the ALT and the AST. In his 9 particular case, he has an ALT of 40 which is normal. 10 He has an AST of 45 which is slightly above the upper 11 limits of normal which is 40. But an AST of 45 with an 12 upper limit normal of 40 is not clinically significant, 13 found in many disease process even obesity and cannot 14 even necessarily be attributed to Hepatitis C. 15 Q. Mr. Maldonado alleges his fibrosis requires 16 immediate treatment to prevent further liver damage or 17 liver failure. Is there anything in these test results 18 that indicates he has liver damage right now or liver 19 failure? 20 A. He has an APRI of 0.40, well below the 21 threshold of the 1.5 that we're focusing on at current. 22 Q. And same thing with going back to Mr. Levya. 23 Do you see anything in his lab test results that 24 indicates he requires immediate treatment or that he's

Page 200

1 conditions, for example?

2 A. I'm not going to say that they can't have

3 pain. I don't know how to correlate that directly with

4 the Hepatitis C excluding all other things. So I don't

5 know.

6 Q. I understand that. But when the patient says

7 I have pain it's possible that it's Hepatitis C before

8 stage 4?

9 A. I don't know that.

10 Q. You were given a bunch of clinical data and

11 you said that all you can tell from that clinical data

12 is that they're below F3; is that correct?

13 A. Yes.

14 Q. They do have Hepatitis C, chronic, right,

15 you've determined that?

16 A. Yes.

17 Q. Okay.

18

And under the guidelines of AASLD they

19 would be treated because they have chronic Hepatitis C?

20 A. Correct.

21 Q. Regardless of all the tests that you've done?

22 A. Correct.

23

- - -

24

EXAMINATION

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Page 201

1

- - -

2 BY MS. YEH:

3 Q. I have just another follow-up question.

4

You had noted -- testified earlier that

5 you used the APRI score the minimum of 1.5 in order to

6 determine whether to refer them for the elastography

7 test, correct?

8 A. During this current group of patients, yes.

9 Q. But in fact, an individual with a lower than

10 1.5 could still, in fact, be either F3 or F4?

11 A. I don't have enough information to know if

12 they could be an F4. They could be an F3.

13 Q. And I apologize, I don't have it right in

14 front of me, but from what I remember Mr. Chimenti had

15 an APRI score of 1.2. But it has been confirmed that

16 he's at stage F4 per his elastography exam?

17 A. I don't know those numbers offhand at all.

18

MS. YEH: Okay.

19

MR. RUDOVSKY: Okay.

20

- - -

21

(Whereupon, the deposition was

22 concluded at 3:17 p.m.)

23

- - -

24

Page 203

1

INSTRUCTIONS TO WITNESSES

2

Read your deposition over carefully.

3 It is your right to read your deposition and make

4 changes in form or substance. You should assign a

5 reason in the appropriate column on the errata sheet

6 for any change made. After making any change in form

7 or substance which has been noted on the following

8 errata sheet along with the reason for any change, sign

9 your name on the errata sheet and date it. Then sign

10 your deposition at the end of your testimony in the

11 space provided. You are signing it subject to the

12 changes you have made in the errata sheet, which will

13 be attached to the deposition before filing. You must

14 sign it in front of a witness. Have the witness sign

15 in the space provided. The witness need not be a

16 notary public. Any competent adult may witness your

17 signature. Return the original errata sheet &

18 transcript to deposing attorney, (attorney asking

19 questions) promptly!

20

Court rules require filing within 30

21 days after you receive the deposition. Thank you.

22

I have read the foregoing deposition

23 and the answers given by me are true and correct, to

24 the best of my knowledge and belief.

Page 202

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1

C E R T I F I C A T E

1

2

- - -

2

3 STATE OF PENNSYLVANIA:

3

4

: SS

5 COUNTY OF PHILADELPHIA:

6

7

I, Michelle Palys, Court Reporter-Notary

8 Public within and for Philadelphia County, State of

4

_______________________

PAUL NOEL, M.D.

5

6

7

8 ___________________________

9 Pennsylvania, do hereby certify that the foregoing

WITNESS TO SIGNATURE

10 testimony of PAUL NOEL, M.D., was taken before me at

9

11 Kairys, Rudovsky, Messing & Feinberg, The Cast Iron

___________________________

12 Building, 718 Arch Street, Suite 501 South,

10 ADDRESS

13 Philadelphia, Pennsylvania on February 24, 2017; that

11

14 the foregoing testimony was taken by me in shorthand by

12

15 myself and reduced to typing under my direction and

13

My Commission Expires

16 control, that the foregoing pages contain a true and

.....................

17 correct transcription of all of the testimony of said

14

18 witness.

15

19

16

20

......................

17

MICHELLE PALYS

18

21

Notary Public

My Commission expires

19 20 21

22

December 23, 2020

22

23

23

24

24

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1

ERRATA SHEET

2 PAGE LINE # CHANGE

REASON THEREFORE

3 __________________________________________

4 __________________________________________

5 __________________________________________

6 __________________________________________

7 __________________________________________

8 __________________________________________

9 __________________________________________

10 __________________________________________

11 __________________________________________

12 __________________________________________

13 __________________________________________

14 __________________________________________

15 __________________________________________

16 __________________________________________

17 __________________________________________

18 __________________________________________

19 __________________________________________

20 __________________________________________

21 __________________________________________

22 __________________________________________

23 __________________________________________

24 __________________________________________

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EXHIBIT L

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EXHIBIT M

Case 2:15-cv-03333-JP Document 101-16 Filed 11/02/17 Page 2 of 14

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

_______________________________________

)

SALVATORE CHIMENTI,

)

)

Plaintiff,

)

v.

)

)

PENNSYLVANIA DEPARTMENT

)

CORRECTIONS (DOC), ET AL

)

)

Defendants.

)

_______________________________________)

CIVIL ACTION No. 15-3333
Judge John R. Padova

PLAINTIFFS’ THIRD SET OF DOCUMENT REQUESTS TO ALL DEFENDANTS

Pursuant to Rule 34 of the Federal Rules of Civil Procedure, Plaintiffs Salvatore

Chimenti, Daniel Leyva, and David Maldonado hereby request that Defendant Pennsylvania

Department of Corrections produce for inspection and copying, within thirty days of the service

of this request, the documents and things set forth below. The production should be made at the

offices of Kairys, Rudovsky, Messing & Feinberg LLP, 718 Arch Street, Suite 501S,

Philadelphia, PA 19106.

INSTRUCTIONS

1. You are required, in responding to these document requests, to obtain and

produce all documents created or obtained in the possession of, available to, or under the control

of you and/or your attorney.

2. Where a specified document is requested, such request shall be interpreted

to include any other documents where it is known that such other documents contain information

relevant to the request.

1

Case 2:15-cv-03333-JP Document 101-16 Filed 11/02/17 Page 3 of 14
3. If a document described by the request was, but no longer is, in existence or subject to the control of you or your attorney, state: (a) the last known location of that document; (b) the names and addresses of all persons with knowledge of the contents of the document; and (c) why the document is no longer in existence or subject to such control.
4. If a document described by the request was previously provided to Plaintiff(s), state: (a) the name of the document; and (b) when and how it was provided.
5. This request represents a continuing request for production. Therefore, if a document described by this request is not in existence or subject to the control of you or your attorney at the time of the first response to this request, but later comes into existence or into the control of you or your attorney, you must immediately produce that document.
6. Any document request propounded in the disjunctive shall also be read as propounded in the conjunctive and vice versa. Any document request propounded in the singular shall also be read as propounded in the plural and vice versa. Any document request propounded in the present tense shall also be read as propounded in the past tense and vice versa. The word “each” shall be understood to include and encompass “every” and vice-versa. “All” and “any” should be understood to mean “any and all.”
7. If a document request calls for a response as to which you claim any privilege, set forth each and every fact on which your claim of privilege is based with sufficient specificity to permit the court to make a determination as to whether your claim of privilege is valid, including, but not limited to: (a) the number and particular part of the document request to which the claimed privileged information is responsive; (b) a description of the information or communications; (c) the date and time of the information or communications; (d) the basis upon which the privilege is claimed; and (e) the identity of each person (other than the attorneys
2

Case 2:15-cv-03333-JP Document 101-16 Filed 11/02/17 Page 4 of 14
representing you in this action) to whom the information or contents of the communication have been disclosed, either orally or by document.
8. If you object to any document request on the ground that the request is overbroad, you are instructed to respond to the document request as narrowed to conform to your objection within the thirty day period allowed for a response.
9. If you object to any document request in whole or in part on the ground that the request is unreasonably burdensome, identify the approximate number and nature of the documents needed to be searched, the location of the documents, and the number of person-hours and costs required to conduct the search. You are instructed to respond to the document request as narrowed to conform to your objection within the thirty day period allowed for a response.
10. No document request should be left unanswered. If the answer to a request or subparagraph of a request is “none” or “unknown,” the word “none” or “unknown” must be written in the answer. If the request is inapplicable, “n/a” must be written as the response.
11. Produce photographs, video, and audio recordings responsive to a document request in the format in which they were originally created. Where photographs were taken digitally, produce an electronic copy. Where photographs exist only in hard copy, produce full resolution copies printed on standard photographic stock.
DEFINITIONS Unless specifically stated otherwise, these requests for the production of documents shall be read and interpreted in accordance with the definitions set forth below: 1. The terms “you,” “your,” and “Department of Corrections” mean the Pennsylvania Department of Corrections as well as all arms, branches, agencies, and departments
3

Case 2:15-cv-03333-JP Document 101-16 Filed 11/02/17 Page 5 of 14
of the Pennsylvania government and including all employees, agents, and others acting on behalf thereof.
2. The term “Plaintiff(s)” refers to Salvatore Chimenti, Daniel Layva, and David Maldonado, the Plaintiffs in the above-captioned action.
3. The terms “document(s)” and “record(s)” include all materials listed in Rule 34(a) of the Federal Rules of Civil Procedure (including, but not limited to, written, typewritten, printed, recorded, taped, graphic, magnetic, photographed, filmed, and computerbased materials) in the possession, custody, or control of you or your attorney, or known by you or your attorney, to exist. If a document has been prepared in several copies, or additional copies have been made that are not identical (or no longer identical by reason of subsequent notation or other modification of any kind whatever, including without limitation notations on the backs of pages thereof) each non-identical copy is a separate document to be produced.
4. The terms “document(s),” “record(s),” and “correspondence” include all emails and texts, including but not limited to those retained in “sent” or other electronic folders, and those contained in accounts on personal or business computers or telephones.
REQUEST FOR PRODUCTION 1. All documents for the period 2012 to the present, including but not limited to all internal memos, correspondence, emails, reports, and/or studies, that discuss, mention, or reference in any form or matter, any limitations on the number of inmates who could be treated with direct acting anti-viral drugs based on security or administrative reasons, i.e., reasons independent of the costs of the direct acting anti-viral drugs (DAADs).
4

Case 2:15-cv-03333-JP Document 101-16 Filed 11/02/17 Page 6 of 14

Dated: March 9, 2016

Respectfully submitted,
/s/ David Rudovsky David Rudovsky, PA Attorney No. 1168 Kairys, Rudovsky, Messing & Feinberg LLP 718 Arch Street, Suite 501S Philadelphia, PA 19106 (215) 925-4400
/s/ Su Ming Yeh Su Ming Yeh, PA Attorney No. 95111 Pennsylvania Institutional Law Project 718 Arch Street, Suite 304S Philadelphia, PA 19106 (215) 925-2966
/s/ Stephen D. Brown Stephen D. Brown, PA Attorney No. 27829 Christine Levin, PA Attorney No. 37807 Dechert LLP Cira Centre 2929 Arch Street Philadelphia, PA 19104 (215) 994-2404

5

Case 2:15-cv-03333-JP Document 101-16 Filed 11/02/17 Page 7 of 14

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

_______________________________________

)

SALVATORE CHIMENTI,

)

)

Plaintiff,

)

CIVIL ACTION

v.

)

)

No. 15-3333

PENNSYLVANIA DEPARTMENT

)

CORRECTIONS (DOC), ET AL

)

)

Judge John R. Padova

Defendants.

)

_______________________________________)

CERTIFICATE OF SERVICE

I, the undersigned, hereby certify that I have on this date caused a copy of the foregoing Plaintiff’s Third Set of Request for Production of Documents to be served upon counsel listed below via electronic mail:

Counsel for DOC Defendants Vincent Mazeski Chief Counsel’s Office Pennsylvania Department of Corrections 1920 Technology Parkway Mechanicsburg, PA vmazeski@pa.gov

Counsel for CCS and Wexford Defendants Samuel Foreman Weber Gallagher Simpson Stapleton Fires & Newby, LLP 2 Gateway Center, Suite 1450 Pittsburgh, PA 15222 sforeman@wglaw.com

Furthermore, I hereby certify that a copy was served via email to the following:

Counsel for CCS and Wexford Defendants Caitlin Goodrich Weber Gallagher 2000 Market Street, 13th Floor Philadelphia, PA 19103 cgoodrich@wglaw.com

Case 2:15-cv-03333-JP Document 101-16 Filed 11/02/17 Page 8 of 14

Noah Evan Kratz Weber Gallagher 201 Penn Ave., Suite 400 Scranton, PA 18503 nkatz@wglaw.com

DATE: March 9, 2016

/s/Su Ming Yeh Attorney ID: PA 95111 Pennsylvania Institutional Law Project 718 Arch Street, Suite 304 South Philadelphia, PA 19106 T: 215-925-2966 smyeh@pailp.org

Case 2:15-cv-03333-JP Document 101-16 Filed 11/02/17 Page 9 of 14

Mail - smyeh@pailp.org

Page 1 of 3

Case 2:15-cv-03333-JP Document 101-16 Filed 11/02/17 Page 10 of 14

RE: Chimenti discovery

Mazeski, Vincent <vmazeski@pa.gov>
Wed 6/7/2017 12:47 PM
To:Su Ming Yeh <smyeh@pailp.org>; drudovsky@krlawphila.com <drudovsky@krlawphila.com>; Cc:'sforeman@wglaw.com' <sforeman@wglaw.com>; cgoodrich@wglaw.com <cgoodrich@wglaw.com>;

Hi Su Ming,
I asked Dr. Noel a similar question on 4/17/17 and was told, nothing else existed. I will forward this request to him to double check.
Thanks. Vince
Vincent R. Mazeski Assistant Counsel Pa. Department of Corrections Office of Chief Counsel 1920 Technology Parkway Mechanicsburg, PA 17050 Tel. (717)728-7763 Fax (717)728-0312
PRIVILEGED AND CONFIDENTIAL ATTORNEY-CLIENT COMMUNICATION ATTORNEY WORK PRODUCT The information transmitted is intended only for the person or entity to whom it is addressed and may contain confidential and/or privileged material. Any use of this information other than by the intended recipient is prohibited. If you receive this message in error, please send a reply e-mail to the sender and delete the material from any and all computers. Unintended transmissions shall not constitute waiver of the attorney-client or any other privilege.
From: Su Ming Yeh [mailto:smyeh@pailp.org] Sent: Friday, June 02, 2017 7:36 PM To: Mazeski, Vincent <vmazeski@pa.gov>; drudovsky@krlawphila.com Cc: 'sforeman@wglaw.com' <sforeman@wglaw.com>; cgoodrich@wglaw.com Subject: RE: Chimenti discovery
Dear Vince, Sam, and Caitlin:
I am following up on discovery, as our time for fact discovery ends on June 19, 2017.
Vince – 1. In reviewing your discovery response to our request for communications (including emails) relating to the implementation of the Hepatitis C policy, can you please supplement this response? We last

https://outlook.office.com/owa/?realm=pailp.org&exsvurl=1&ll-cc=1033&modurl=0&pat... 11/2/2017

Mail - smyeh@pailp.org

Page 2 of 3

Case 2:15-cv-03333-JP Document 101-16 Filed 11/02/17 Page 11 of 14

received a production of emails from you around February 1, 2017, and the emails produced end in August or September 2016. Please produce any correspondence (if any) after August or September 2016 to the present, regarding the implementation of the Hepatitis C protocol, including correspondence relating to cost or other administrative factors relating to the protocol.
Sam and Caitlin – 1. Have you had an update about Dr. Kephart and his discovery responses and deposition? As you know, our fact discovery deadline is arriving soon. I understand that you have had difficulty receiving a response from him, but we do not want to hold up the rest of the case due to his non-response. We would prefer not to have to resort to filing a motion to compel, as I believe we have kept our lines of communication open so far, but we might have to, so please let me know the status.
2. We are also waiting for responses regarding: a. Plaintiffs’ Third Set of Document Requests to All Defendants (March 9, 2017): all documents and correspondence regarding limitations on the number of inmates who can be treated for reasons independent of costs b. Plaintiff’s Third Set of Interrogatories (March 9, 2017): number of inmates with chronic Hep C at each fibrosis score
c. Plaintiffs’ Fourth Set of Document Requests to All Defendants (April 12, 2017): All emails and written correspondence to/from Dr. Cowan to staff that discuss DAA and Hep C treatment for the 3 named plaintiffs
d. Plaintiff’s Fourth Set of Interrogatories to All Defendants (April 12, 2017): The number of inmates with chronic Hep C who have been authorized to receive DAA treatment at each fibrosis level; the number of inmates at each APRI score who have received the DAA treatment
e. Plaintiffs’ Fifth Set of Document Requests (but misnamed as Fourth Set of Document Requests) (April 26, 2017): All emails and written correspondence to/from Dr. Frommer or Dr. Kephart regarding DAA and Hep C treatment for the named plaintiffs; and the personnel files of Dr. Frommer and Dr. Kephart
Also, in terms of scheduling, please note that I will be on vacation from June 21-30, 2017. Thanks.
Su Ming

- - - -Su Ming Yeh Managing Attorney Pennsylvania Institutional Law Project 718 Arch St., Ste. 304S Philadelphia, PA 19106 T: 215-925-2966 F: 215-925-5337
From: Mazeski, Vincent [mailto:vmazeski@pa.gov] Sent: Monday, May 22, 2017 4:43 PM To: Su Ming Yeh <smyeh@pailp.org>; drudovsky@krlawphila.com Cc: 'sforeman@wglaw.com' <sforeman@wglaw.com>; cgoodrich@wglaw.com Subject: Chimenti discovery

https://outlook.office.com/owa/?realm=pailp.org&exsvurl=1&ll-cc=1033&modurl=0&pat... 11/2/2017

Mail - smyeh@pailp.org

Page 3 of 3

Case 2:15-cv-03333-JP Document 101-16 Filed 11/02/17 Page 12 of 14

Greetings Counsel,
As a follow up to recent discovery requests and answers, please find attached emails from Dr. Cowan or Dr. Frommer regarding Mr. Chimenti. These were provided to me from Dr. Noel and Mr. Wenhold. The 3 CHCAs at the 3 relevant institutions where the 3 named Plaintiffs are housed had nothing responsive to the discovery request.
From my end (DOC), I think this concludes regular discovery/outstanding responses. Please advise if you have any differing thoughts.
Thanks. Vince
Vincent R. Mazeski Assistant Counsel Pa. Department of Corrections Office of Chief Counsel 1920 Technology Parkway Mechanicsburg, PA 17050 Tel. (717)728-7763 Fax (717)728-0312
PRIVILEGED AND CONFIDENTIAL ATTORNEY-CLIENT COMMUNICATION ATTORNEY WORK PRODUCT The information transmitted is intended only for the person or entity to whom it is addressed and may contain confidential and/or privileged material. Any use of this information other than by the intended recipient is prohibited. If you receive this message in error, please send a reply e-mail to the sender and delete the material from any and all computers. Unintended transmissions shall not constitute waiver of the attorney-client or any other privilege.

https://outlook.office.com/owa/?realm=pailp.org&exsvurl=1&ll-cc=1033&modurl=0&pat... 11/2/2017

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EXHIBIT N

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EXHIBIT O

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EXHIBIT P

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EXHIBIT Q

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EXHIBIT R

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 2 of 22

IN THE UNITED STATES DISTRICT COURT EASTERN DISTRICT OF PENNSYLVANIA

Page 1

SALVATORE CHIMENTI, )

DANIEL LEYVA, DAVID )

MALDONADO, and all )

others similarly

)

situated,

)

)

Plaintiff,

)

)

vs.

)

)

PENNSYLVANIA

)

DEPARTMENT

)

CORRECTIONS (DOC); )

JOHN WETZEL,

)

Secretary of the

)

(DOC); PAUL NOEL,

)

Chief Medical

)

Director,

)

Pennsylvania (DOC); )

CHRISTOPHER OPPMAN, )

Director, Bureau of )

Health Care

)

Services, (DOC); DR. )

KEPHART, Medical

)

Director, SCI

)

Graterford; JOSEPH )

C. KORSZNIAK,

)

Correctional Health )

Care Administrator, )

SCI Graterford;

)

CORRECT CARE

)

SOLUTIONS (CCS); DR. )

NICHOLAS SCHARFF,

)

Medical Director,

)

CCS; WEXFORD HEALTH )

SOURCES, INC.; DR. )

THOMAS LEHMAN,

)

Medical Director,

)

Wexford Health

)

Source, Inc.,

)

)

Defendants.

)

Civil Action No. 2:15-cv-03333

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 3 of 22

Page 2

1

- - -

DEPOSITION OF SALVATORE CHIMENTI

2

FRIDAY, MAY 19, 2017

- - -

3

4

The Deposition of SALVATORE CHIMENTI, a

5 Plaintiff herein, called by the Defendants, taken

6 pursuant to Notice of Deposition and the

7 Pennsylvania Rules of Civil Procedure, by and

8 before Faye Ann Lehman, a Notary Public in and for

9 the Commonwealth of Pennsylvania, at State

10 Correctional Institution at Smithfield, 1120 Pike

11 Street, Huntingdon, Pennsylvania 16652, commencing

12 at 11:00 a.m. on the day and date above set forth.

13

- - -

14

15

16

17

18

19

20

21

22

23

24

25

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 4 of 22

1 APPEARANCES:

Page 3

2 On behalf of the Plaintiff:

3

Su Ming Yeh, Esquire

Pennsylvania Institution Law Project

4

718 Arch Street, Suite 304 - South

Philadelphia, Pennsylvania 19106

5

6 On behalf of the Defendants:

7

Vincent R. Mazeski, Esquire

Chief Counsel's Office

8

Pennsylvania Department of Corrections

1920 Technology Parkway

9

Mechanicsburg, Pennsylvania 17050

10 On behalf of the Defendants:

11

Samuel H. Foreman, Esquire

Weber, Gallagher, Simpson

12

Stapleton, Fires & Newby, LLP

Four PPG Place

13

5th Floor

Pittsburgh, Pennsylvania 15222

14

15

- - -

16

I N D E X

17 WITNESS

PAGE

18 SALVATORE CHIMENTI

19 Examination by Mr. Foreman

4

Examination by Mr. Mazeski

54

20 Examination by Ms. Yeh

70

21 EXHIBITS
22 ***NONE***
23

24 - - -
25

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 5 of 22

Page 31 1 time -- I mean, whose idea was it to put you on

2 triple therapy? How did that come about?

3 A.

Due to the lawsuit that I had and that I

4 filed and was still ongoing.

5 Q.

Okay.

6 A.

And I believe that I was the first one in

7 the state to receive the triple therapy. I was the

8 very first inmate in the entire state to receive it

9 because of how bad my liver was at that time.

10 Q.

Right.

11 A.

So it was bad then. It's even worse now

12 three years later, a lot worse. I can't even do

13 none of the things I was able to do then now.

14 Q.

Okay. Let's -- let me stop you right there.

15 Let's just explore that so we get that out of the

16 way.

17 A.

All right.

18 Q.

What things can't you do now that you could

19 do three years later? I mean, how is your life

20 worse now because of what you're suing in this

21 case?

22 A.

Well, how my life got worse? Well, I --

23 Q.

Let's talk about in terms of your daily

24 activities.

25 A.

I have no daily activities. I can't do any

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 6 of 22

Page 32 1 daily activities. That's the thing. I have no

2 energy whatsoever, none. I could sleep 24/7.

3 Q.

Okay.

4 A.

All I do is sleep. I'm tired. I have no

5 energy to do anything. I have such bone and muscle

6 pain that I can't even do -- I have a problem with

7 my arm. I can't even do curl-ups. I was doing

8 curl-ups. I was doing lightweight -- lightweight

9 workouts with the weights.

10 Q.

Uh-huh.

11 A.

I can't -- I can't curl, man, because I have

12 developed a rash. There's a rash right there, you

13 know? This has been there four months, and they

14 tried every cream possible, and they still can't

15 get rid of it. So now they have to do a biopsy of

16 it.

17 Q.

Okay.

18 A.

So I'm getting rashes, you know, all

19 different types of weird rashes that I've never had

20 before. But the bone pain in my knees when I'm

21 sitting up -- if I get up from this chair, it's

22 excruciating pain behind my knees, back here, my

23 lower back, my -- my arms, my joints, and my

24 shoulders and my elbows. I'm just like I'm a

25 walking -- it's horrible, man. I was able to do

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 7 of 22

Page 33 1 all this stuff. I was able to do push-ups before.

2 I did push-ups before I even started the therapy

3 with Frommer.

4 Q.

Right.

5 A.

And I was -- I was -- I was walking -- I

6 could walk the whole yard.

7 Q.

Right.

8 A.

I can -- I walk now 15 minutes and my ankles

9 starts -- starts hurting, like somebody -- like I

10 sprained it. I feel like I got a sprained ankle; I

11 mean, a legitimate sprained ankle. I can show you

12 my ankles right there on my legs, right?

13 Q.

Uh-huh.

14 A.

Look at my legs, how swollen they are. I

15 mean, I didn't have that. And I developed

16 diabetes. I didn't have diabetes in 2013, but I

17 have it now.

18 Q.

Okay. When were you diagnosed with

19 diabetes?

20 A.

Well, I had prediabetes, like, about

21 two years ago, and then they started me on insulin

22 three times a day about a year and a half ago,

23 approximately. I'm not -- I can't give you the

24 dates.

25 Q.

Are you taking any oral medication?

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 8 of 22

1 A.

I'm taking oral and injections.

Page 34

2 Q.

And injections?

3 A.

I take insulin injections three times a day

4 at 7, 5 -- at 7, 11 and 5.

5 Q.

Okay.

6 A.

And I take two -- three pills a day. It's

7 called Prandin.

8 Q.

Okay. And do you attribute having gotten

9 diabetes to the -- anything having to do with

10 treatment of your liver?

11 A.

Well, there is literature saying that it can

12 cause -- so I'm not a doctor. I don't know. I

13 mean, you know, I can't tell you for sure, for

14 certain, you know what I mean? But there's

15 literature that says that you can develop diabetes

16 when you have cirrhosis, and I have stage 4

17 cirrhosis.

18 Q.

Okay. You have been treated with direct

19 acting antiviral agents now; is that right?

20 A.

Right.

21 Q.

And I think you completed the -- did you

22 take --

23 A.

The 12 weeks, yes.

24 Q.

And you completed that in December?

25 A.

December.

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 9 of 22

1 Q.

And --

Page 35

2 A.

Christmas was my -- was my last dose.

3 Q.

Okay. And what did you take, Harvoni?

4 A.

Harvoni.

5 Q.

Any other medication along with it or just

6 Harvoni?

7 A.

I was taking Ribavirin with it --

8 Q.

Okay.

9 A.

-- but my bilirubin because my liver being

10 as bad as it is --

11 Q.

Right.

12 A.

-- my bilirubin shot up to 6.7.

13 Q.

Okay.

14 A.

And my high norm is, like, 2-point

15 something, and it's gone up as high as like 3-point

16 something. I have never seen 6.7 --

17 Q.

So they took off Ribavirin --

18 A.

They took me off Ribavirin, and I believe it

19 got back down to 3.6, I believe. From 6.7 to 3.6.

20 Q.

That's why --

21 A.

When I say 6.7, I'm like, whoa, because

22 that's indicative of your liver shutting down.

23 Q.

Right. And you -- 12 weeks after you

24 finished treatment, you ended up having a free

25 viral load; isn't that right?

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 10 of 22

1 A.

Page 36 Right. I had to wait three months to get

2 the test.

3 Q.

Right.

4 A.

And they did the test, and it came up clean.

5 Q.

Okay.

6 A.

Now, Dr. Rabinowitz just repeated that.

7 Q.

Did he? Okay.

8 A.

Yes. He just ordered that, and he did an

9 ammonia test.

10 Q.

Right.

11 A.

He took like 12 tubes of blood from me --

12 Q.

Right.

13 A.

-- that I haven't got -- I'm sure it's not

14 here yet.

15 Q.

All right. So that's still pending?

16 A.

Yes.

17 Q.

Do you see -- do you go out to see

18 Rabinowitz or do you see him in --

19 A.

I went -- actually went to Pittsburgh.

20 Q.

Just this week?

21 A.

On Tuesday.

22 Q.

Okay.

23 A.

I believe -- I believe it was Tuesday.

24 Q.

Okay. And how frequently do you see

25 Rabinowitz?

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 11 of 22

1 A.

Well, last time I saw him was about

Page 37

2 ten months ago.

3 Q.

Okay.

4 A.

And now he wants to see me, again, in

5 six months.

6 Q.

Okay.

7 A.

He wants to follow-up and, you know, we

8 haven't discussed the lesion either on my -- on my

9 liver.

10 Q.

Right.

11 A.

We haven't even discussed what that put me

12 through. Holy torture. When the doctor told me I

13 had cancer, I was crying. I was emotionally

14 distressed.

15 Q.

Let's talk about that. When did you find

16 out that you had a lesion on your liver?

17 A.

Okay. I believe it was October.

18 Q.

Of? Just this past October or --

19 A.

'16. I can't remember the date for sure.

20 Q.

I'm just trying to get a ballpark on how

21 long ago --

22 A.

It was either May or October, one of those

23 months.

24 Q.

Okay.

25 A.

I can't remember.

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 12 of 22

1 Q.

Who told you --

Page 38

2 A.

Who told me -- Dr. Frommer -- they ordered a

3 CT scan --

4 Q.

Right.

5 A.

Finally -- I finally got a CT scan that

6 Dr. Kephart wouldn't do. I said, it's been over a

7 year. I said, I'm due -- according to a specialist

8 in Pittsburgh, he wrote the judge in my last

9 lawsuit that I should get pictures of my liver

10 taken every six months.

11 Q.

Right.

12 A.

Well, we're talking about 18 months maybe.

13 And then I was saying -- telling Dr. Kephart, man,

14 you know, I'm overdue for a CT scan. You keep

15 giving me ultrasounds and ultrasounds are not

16 definitive --

17 Q.

Right.

18 A.

Because the ultrasounds I had right before

19 the CT scan didn't show any mass. So that's a

20 telltale indicator that -- that the ultrasound

21 wasn't showing anything. As soon as I got the CT

22 scan, it came back with two lesions, one on my

23 back. On my lower spine I had a spot that was

24 suspicious and then I had this tumor --

25 Q.

Lesion?

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 13 of 22

1 A.

Page 39 Liver lesion or, you know, whatever you want

2 to call it. The mass. A mass I call it. I had a

3 mass in -- back here in my lower part, right next

4 to the lung.

5 Q.

Okay.

6 A.

So I was called down into the office, down

7 to the medical by Dr. Frommer. He sits me down and

8 he says, you have -- your results came back and you

9 have hepatocellular cancer.

10 Q.

So Dr. Frommer told you you have cancer?

11 A.

That I have cancer --

12 Q.

Okay.

13 A.

-- and he should -- he should have been --

14 he should have been completely sure before he gave

15 me that bad news because I suffered, crying in my

16 cell, you know, I was thinking I was going to die.

17 You know, it was horrible. And then he says, I

18 want you to do a liver biopsy --

19 Q.

Okay.

20 A.

So -- this is exactly what he said, so we

21 can determine what kind of cancer you have so we

22 know the best treatment to give you for your

23 cancer.

24 Q.

Okay.

25 A.

And that was the reason -- the purpose for

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 14 of 22

1 the liver biopsy.

Page 40

2 Q.

Right.

3 A.

So I called my doctor.

4 Q.

Cecil?

5 A.

Cecil. He says, if you have hepatocellular

6 cancer, you don't need a liver biopsy. None of the

7 doctors are doing it anymore.

8 Q.

All right.

9 A.

He said it's not necessary. It's a high

10 risk of what they call seeding, spreading the

11 cancer, and you can bleed out, okay? So I told

12 doctor -- I refused the first time they tried --

13 attempted to take me out to do this biopsy. I

14 said, I was scared. And even Dr. Agra that worked

15 here --

16 Q.

Right.

17 A.

-- even he said he was against me doing a

18 biopsy and he's a retired surgeon. Even Dr. Agra

19 wrote in his report that he didn't recommend me

20 doing a liver biopsy because it's too dangerous,

21 so...

22 Q.

Dangerous for what reasons, bleeding or

23 spreading the tumor --

24 A.

For both. He said I can bleed out.

25 Q.

Okay.

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 15 of 22

1 A.

Page 41 He said, I'm a surgeon. I know -- you know,

2 he said I wouldn't get it. He went over

3 Dr. Frommer's recommendation and told me --

4 actually told me not to get it.

5 Q.

Okay.

6 A.

So I said, okay, I'm believing doctor --

7 because Dr. Agra is a good doctor. Dr. Agra is an

8 excellent doctor, in fact. He knew -- he knew his

9 stuff. You know, he knew. You know, he knew. But

10 I refused the first time. The second time, they

11 wanted me to come back here with no overnight

12 clothes. So they called me up here to medical to

13 spend the night in medical. They said, I think you

14 should spend the night in medical. It's like they

15 make sure you don't eat or drink --

16 Q.

Right, right.

17 A.

You know, it's like a precaution. I said,

18 well, let me go back and my stuff. Oh, no, no, you

19 can't go back to the block now. I said, what? I

20 said, I've got no clean underwear, no cosmetics, no

21 nothing. I said, I'm not doing it. I said, I

22 refuse.

23 Q.

Okay.

24 A.

So I went back to the block. Now the third

25 time, I -- I agreed to go.

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 16 of 22

1 Q.

Page 42 Right. Tell me -- tell us about that time.

2 A.

That time?

3 Q.

Where did you --

4 A.

I went to Altoona -- UPMC Altoona, and I saw

5 this Dr. James, I believe it was. This was all --

6 this is all --

7 Q.

It's in the records. I just wanted to know

8 what you remember.

9 A.

I just went over this last night. I was

10 reading my grievance, and I mentioned all five

11 doctors that I saw, all five radiologists who gave

12 different opinions. Each one of them except for

13 two that were on the same -- the same, you know --

14 what's the word I'm looking for -- were in

15 agreement.

16 Q.

Right.

17 A.

Two doctors were in agreement, that it was

18 a -- that it was cancer.

19 Q.

Okay.

20 A.

Okay? Now, the first doctor who did the CT

21 scan, he wrote down that I had suspected carcinoma;

22 you know, hepatic carcinoma. And that's when I go

23 down to get the biopsy. So I go to Altoona, and I

24 see a Dr. James, and he reviewed my CT scans and

25 ultrasounds. He comes back into the room, he says,

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 17 of 22

Page 43 1 we're not going to do the biopsy. He says, because

2 I don't believe it's -- I don't believe it's

3 cancer. I said, awe, man, I was so happy. Here,

4 the whole time I'm thinking I've got cancer and

5 they wanted to do this so they could find out the

6 best treatment for me.

7

That's all it was about. Boy, I was so

8 upset with Dr. Frommer, man, telling me that I had

9 cancer. You don't know how many -- how many weeks

10 I suffered, man, thinking about this. Literally

11 crying like a baby in my cell. Someone came by my

12 cell, said, you all right? They told my sergeant

13 on the block to check on me --

14 Q.

Uh-huh.

15 A.

-- after I got the news because I was like

16 livid by the news, you know?

17

So Dr. James comes in and tells me that day

18 it was a hemangioma --

19 Q.

Right.

20 A.

-- which is a gathering of blood vessels --

21 Q.

And you might bleed, right?

22 A.

Yeah. And so he recommended that I have red

23 blood tags, a flagged red blood cell, like a

24 nuclear test --

25 Q.

Right.

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 18 of 22

1 A.

Page 44 So it can weed-out the hemangioma. So I had

2 that done about four weeks later. I had that done

3 approximately four weeks later.

4 Q.

Right.

5 A.

And it came back negative for hemangioma.

6 Q.

Uh-huh.

7 A.

Now, the next doctor who I saw, he went

8 for -- for that I got the red blood cell, I

9 think --

10 Q.

Uh-huh.

11 A.

He -- he wrote that he thinks I had cancer.

12 Q.

Right.

13 A.

I forget his name. I think it was Kuzukele,

14 Kuzukel, something like that.

15 Q.

It doesn't matter. As long as we get --

16 what you remember and the sequence.

17 A.

Right. And he recommended another MRI -- or

18 a CT scan it was, to get to -- to delineate the --

19 what it actually is.

20 Q.

Right.

21 A.

What this mass actually is, to delineate --

22 I don't know if I'm saying it right.

23 Q.

Delineate, I think, is what you're --

24 A.

Delineate.

25 Q.

Yeah.

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 19 of 22

1 A.

Page 45 Delineate is what it was. And so I go back,

2 again, to get another biopsy. He recommended a

3 biopsy -- he recommended a biopsy, so I go back

4 and I get another biopsy. And this Dr. Shivers

5 comes out and says, I'm not doing the biopsy

6 because he thinks it's a hepatic -- no, an arterial

7 venous -- arteriovenous fistula.

8 Q.

Right.

9 A.

And he told me that if he stuck that with a

10 needle, it would be like hitting a major artery.

11 Q.

Right.

12 A.

I would definitely bleed out. And he said

13 the location of the -- of the mass is right next to

14 the lung because they also hit the lung, and my

15 lung will collapse during the procedure. I'm not

16 doing it. So that's -- and then I forget who came

17 next.

18

So he sends me out for another CT, and it

19 wasn't an arterial fistula. I think at that

20 point -- I wish I had -- I can refer to notes or --

21 Q.

Let's just go from what you remember, but I

22 understand.

23 A.

All right. And Dr. Shivers, he said that he

24 recommends against the biopsy. So now I have all

25 these different diagnoses. This doctor that it was

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 20 of 22

Page 46 1 cancer, this other doctor thought it was a cancer,

2 now this doctor thinks it's a fistula. So I said,

3 look, he had this. I had a meeting with Dr.

4 Frommer and I made sure all these other doctors

5 were in the room. Even the doctor, psychiatrist

6 was in the room, and we discussed my current

7 condition in this room, this conference room. And

8 I said, well, look, man, I says, it only makes

9 sense that I should be sent to a hepatologist. Let

10 them decide what this mass is, you know.

11

So doctor -- and everybody in the room, I

12 believe -- I think Mr. Hartman was in the room as

13 well. Even Mr. Hartman was in agreement with my

14 requests to see the hepatologist at UPMC because

15 they have a contract -- UPMC has a contract with

16 the prison, you know. And I've heard a lot of good

17 things about their hepatology because that's where

18 I saw my last doctor with the other lawsuit,

19 doctor -- what was his name?

20

Dr. Abenar -- A-B, Abenar. He was appointed

21 to Judge Bananski (phonetic). He was his appointed

22 specialist, and he's the one that recommended that

23 I should get studies of my -- pictures of my liver

24 every six months and that I should be evaluated if

25 my MELD score goes up to 11, and I'm qualified to

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 21 of 22

Page 47 1 be evaluated. He has this all in his report which

2 is in the other lawsuit. You still have his

3 recommendations to the judge. This is the judge's

4 specialist, not mine. So I said to him, I said --

5 I told him, I said, why can't I be sent to UPMC and

6 let me be evaluated by their hepatologist and to

7 get a recommendation for -- to be treated with

8 Harvoni? So he puts in a recommendation, doctor --

9 he says, I'll e-mail Mr. -- Dr. Noel or Dr. Shaw, I

10 believe. It was one of them two.

11 Q.

And who said that, Frommer?

12 A.

Frommer. He said, I'm going to e-mail him

13 and tell him to send you to Pittsburgh to be

14 evaluated by a hepatologist. He was in agreement

15 to what I was saying because I got all these -- he

16 was so, like, adamant about me getting this biopsy,

17 and it could have killed me, you know what I mean?

18 And he wrote -- he didn't write a referral. He

19 wrote my request. Mr. Chimenti's requesting. I

20 said, I thought you were going to write me a

21 recommendation for me to the central office, and he

22 didn't do that. I was kind of ticked off.

23 Two weeks later, he calls me down and Ms. -- I

24 believe Ms. -- who is it -- Ms. Cutshaw, okay.

25 Debbie Cutshaw was in there, and they both sat me

Case 2:15-cv-03333-JP Document 101-21 Filed 11/02/17 Page 22 of 22

Page 48 1 down and they said, listen, I e-mailed your request

2 to be sent to Pittsburgh. Your request was denied.

3 Q.

By who; do you know?

4 A.

By Dr. Noel or Dr. Cowan. I don't know, I

5 think it's Noel. I think it was Noel. He told me,

6 and I said, what, so now what? You know, he says,

7 I don't know. I said, what about -- and they never

8 even mentioned the Harvoni. They didn't even bring

9 that up, Harvoni. And I was so upset, I forgot to

10 ask him what about Harvoni because I had such a

11 distaste in my mouth.

12 Q.

Well, it wasn't very much long after that,

13 though, that you didn't go to the UPMC people;

14 isn't that right?

15 A.

I think this meeting took place sometime, I

16 believe, maybe like --

17 Q.

I mean, it was months?

18 A.

Yeah, months, several months.

19 Q.

Okay.

20 A.

You know, I saw a doctor. Well, during the

21 visit -- this was March, April, June, July -- July,

22 maybe like five months later.

23 Q.

Do you know how it was that that -- I mean,

24 you were told you can't go see the UPMC

25 hepatologist, and then just a few months later, you

Case 2:15-cv-03333-JP Document 101-22 Filed 11/02/17 Page 1 of 12
EXHIBIT S

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Chimenti v. DOC Kephart Deposition Medical Records 000091

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Chimenti v. DOC Kephart Deposition Medical Records 000092

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Chimenti v. DOC Kephart Deposition Medical Records 000102

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Chimenti v. DOC Kephart Deposition Medical Records 000107

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Chimenti v. DOC Kephart Deposition Medical Records 000112

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Chimenti v. DOC Kephart Deposition Medical Records 000026

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EXHIBIT W

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Case 2:15-cv-03333-JP Document 101-27 Filed 11/02/17 Page 1 of 6
EXHIBIT X

Case 2:15-cv-03333-JP Document 101-27 Filed 11/02/17 Page 2 of 6
Inmate Handbook 2017 Edition
John E. Wetzel Secretary of Corrections
The Pennsylvania Department of Corrections operates as one team, embraces diversity, and commits to enhancing public safety. We are proud of our reputation as leaders in the corrections field. Our mission is to reduce criminal behavior by providing individualized treatment and education to offenders, resulting in successful community reintegration through accountability and positive change.

Case 2:15-cv-03333-JP Document 101-27 Filed 11/02/17 Page 3 of 6
Inmate Handbook 2017 Edition Table of Contents
I. Accounting..............................................................................................................................1 A. General ............................................................................................................................1 B. Collection of Inmate Debts (DC-ADM 005) ......................................................................3 C. Copying Charges .............................................................................................................3 D. Private Business ..............................................................................................................3
II. Daily Operations .....................................................................................................................4 A. Identification Cards ..........................................................................................................4 B. Pass System ....................................................................................................................4 C. Request Slips...................................................................................................................4 D. Searches of Inmates and Cells (DC-ADM 203)................................................................4 E. Facility Management........................................................................................................6 F. Resolution of Problems ....................................................................................................6 G. Abuse Allegations (DC-ADM 001)....................................................................................6 H. Prison Rape Elimination Act (PREA) (DC-ADM 008).......................................................7 I. Inmate Grievance System (DC-ADM 804) .......................................................................9
III. Inmate Services/Privileges ...................................................................................................11 A. Cable Television (DC-ADM 002)....................................................................................11 B. Cell Assignments ...........................................................................................................11 C. Commutation..................................................................................................................11 D. Correctional Plan ...........................................................................................................11 E. Education (Academic and Vocational) ...........................................................................11 F. Food Services (DC-ADM 610) .......................................................................................12 G. Grooming (DC-ADM 807)...............................................................................................13 H. Mail and Incoming Publications (DC-ADM 803) .............................................................14 I. Outside Assignments (DC-ADM 805) ............................................................................16 J. Parole Services..............................................................................................................16 K. Recreation and Activities ...............................................................................................16 L. Religious Activities (DC-ADM 819) ................................................................................16 M. Specialized Treatment Programs...................................................................................19 N. Telephone Calls (DC-ADM 818) ....................................................................................19 O. Transfers........................................................................................................................21 P. Volunteers and Interns Interacting with Inmates ............................................................22 Q. Reentry and Release Planning ......................................................................................23
IV. Organizations (DC-ADM 822)...............................................................................................23 V. Legal Issues .........................................................................................................................24
A. Alcohol and Other Drug Testing.....................................................................................24 B. Criminal Violations (DC-ADM 004).................................................................................24 C. DNA Collection...............................................................................................................24 D. Megan’s Law Registration..............................................................................................24 E. Legal Services (DC-ADM 007).......................................................................................25 F. Release of Information (DC-ADM 003) ..........................................................................26 G. Riots, Hostages, and Disruptive Behavior......................................................................26 H. Sentence Calculation Questions ....................................................................................27 VI. Medical Services...................................................................................................................27 A. Accommodations for Inmates with Disabilities (DC-ADM 006).......................................27 B. Medical Services (DC-ADM 820) ...................................................................................27 VII. Property (DC-ADM 815) ......................................................................................................28 A. Basic Issue.....................................................................................................................28

Case 2:15-cv-03333-JP Document 101-27 Filed 11/02/17 Page 4 of 6
Inmate Handbook 2017 Edition Table of Contents
B. Cell Content Limit...........................................................................................................29 C. Commissary ...................................................................................................................29 D. Contraband ....................................................................................................................30 E. Outside Purchases.........................................................................................................31 F. Shipping of Personal Property .......................................................................................32 G. State Issued Items .........................................................................................................32 VIII. Rules ..................................................................................................................................33 A. Administrative Custody Procedures (DC-ADM 802) ......................................................33 B. General Rules ................................................................................................................34 C. Housing Unit Rules ........................................................................................................35 D. Misconducts (DC-ADM 801) ..........................................................................................36 IX. Use of Force (DC-ADM 201) ................................................................................................41 X. Visiting (DC-ADM 812) .........................................................................................................42 A. Private Viewing/Deathbed Visits ....................................................................................42 B. News Media Relations (DC-ADM 009)...........................................................................42 C. Visiting Privileges (DC-ADM 812) ..................................................................................42 XI. Work Assignments (DC-ADM 816) .......................................................................................47 A. General ..........................................................................................................................47 B. Pay System....................................................................................................................47 C. Length of Work Day or Work Week................................................................................48 D. Pay Rates ......................................................................................................................48 E. Pay Changes .................................................................................................................48 F. Illness or Injury...............................................................................................................48 G. General Labor Pool........................................................................................................49 H. Assignment to Restricted Housing Unit (RHU)...............................................................49

Case 2:15-cv-03333-JP Document 101-27 Filed 11/02/17 Page 5 of 6

2017 Inmate Handbook

Page 9

b. Third party reports can be made to the Sexual Abuse Reporting Address, BCI/PREA Coordinator, 1800 Elmerton Ave., Harrisburg, PA 17110. (28 C.F.R. §115.51, §115.54)

7. Victims of Sexual Abuse Have Access to Free Support Services (28 C.F.R. §115.53) Write to request more information: PCAR, Pennsylvania Coalition Against Rape, P.O. Box 400, Enola, PA 17025. You may also contact your facility’s PREA Compliance Manager for access to this service.

I. Inmate Grievance System (DC-ADM 804)

1. You are encouraged to attempt resolution of a concern informally by use of a DC-135A, Inmate’s Request to Staff Member or direct conversation with the Unit Manager or Officerin-Charge prior to submitting a DC-804, Part 1, Official Inmate Grievance Form. This is not required in cases of allegations of physical or sexual abuse.

2. For an emergency you should speak to the nearest staff person as soon as possible.

3. A grievance regarding an allegation of a sexual nature (abuse/harassment) against a staff member or inmate-on-inmate sexual abuse will not be addressed through the Inmate Grievance System and must be addressed through DC-ADM 008, “PREA.”

4. The grievance procedure does not apply to issues covered under DC-ADM 801 and DC-ADM 802, “Administrative Custody Procedures.”

5. You must submit a grievance to the Facility Grievance Coordinator/designee, within 15 working days after the event upon which the claim is based.

6. A grievance must be filed with the Facility Grievance Coordinator/designee at the facility where the grievance event occurred.

7. You must sign and date the grievance with your commitment name and number only, without reference to the UCC, aliases, etc.

8. The text of the grievance must be legible, understandable, and presented in a courteous manner. You must include a statement of the facts relevant to the claim.

9. The statement of facts must not exceed two pages and must be handwritten or typed on writing paper (one DC-804, Part 1 and one one-sided 8 ½” x 11” page).

10. If you have been personally affected by a Department and/or facility action or policy, you may submit a grievance.

11. Any grievance based on separate events must be presented separately, unless it is necessary to combine the issues to support the claim.

12. Any grievance issue that has been or is currently being addressed will not be re-addressed in a subsequent grievance. Further, any concern disputing a previous grievance, initial review response, appeal decision, or actions of staff members who rendered those decisions must be addressed through the appeal process.

13. Each grievance must be presented individually. A grievance submitted by one inmate for another inmate or a group of inmates is prohibited and will not be processed.

Case 2:15-cv-03333-JP Document 101-27 Filed 11/02/17 Page 6 of 6

2017 Inmate Handbook

Page 10

14. If filing a grievance related to a claim of missing property, you must provide documentation such as a DC-153, Personal Property Inventory Sheet; DC-154A, Confiscated Items Receipt; or a Commissary/Outside Purchase Form for evidence or proof that the property items were once in your possession.

15. A grievance related to a publication/photograph denial must include a copy of the Notice of Incoming Publication Form in accordance with DC-ADM 803.

16. If you file a grievance contesting the accuracy of the Notification of Deductions Memo and/or the Notification of Amended Deductions Memo in accordance with DC-ADM 005, “Collection of Inmate Debts,” you must provide valid, official court documentation to dispute such. See DC-ADM 005 for further instruction.

17. You must notify the Superintendent or Facility Grievance Coordinator to retain personal property related to a grievance.

18. You shall not be punished, retaliated against, or otherwise harmed for use of the grievance system.

19. If you file five grievances within a 30-day period which have been determined to be frivolous, you may be placed on grievance restriction.

20. At any point in the grievance process, you may withdraw the grievance. To withdraw a grievance, you must use and sign the Grievance Withdrawal Form.

21. Any document(s) attached in support of a grievance becomes part of the official record and will not be returned to you.

22. A time extension for filing a grievance will be considered on a case-by-case basis.

23. Upon receiving a response to your grievance, you have 15 working days from the date of the initial response to file an appeal to the Superintendent.

24. An appeal to the Superintendent must be clearly labeled as an appeal or you may use the Inmate Appeal to Facility Manager Form. You must include a reason(s) for appealing to the Superintendent.

25. You must receive a response from the Superintendent before appealing to the Secretary’s Office of Inmate Grievances and Appeals (SOIGA). You have 15 working days from the date of the Superintendent’s decision to appeal to SOIGA. Appeals must be addressed to:

Chief, Secretary’s Office of Inmate Grievances and Appeals Department of Corrections 1920 Technology Parkway Mechanicsburg, PA 17050

26. You must include legible photocopies of the initial grievance, all responses, and a brief appeal to SOIGA containing a reason for appealing the Superintendent’s decision. SOIGA has 30 working days from the receipt of your appeal to respond.

CHIMENTI et al v. PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC) et al, Docket No. 2:15-cv-03333 (E.D. Pa. Jun 12,
General Information

Court
Federal Nature of Suit Docket Number

United States District Court for the Eastern District of Pennsylvania; United States District Court for the Eastern District of Pennsylvania Prisoner Petitions - Civil Rights[550] 2:15-cv-03333

© 2017 The Bureau of National Affairs, Inc. All Rights Reserved. Terms of Service // PAGE 440

 
 Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 1 of 21

IN THE UNITED STATE DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

SALVATORE CHIMENTI, DANIEL

:

LEYVA, DAVID MALDONADO, and all

:

others similarly situated,

:

:

Plaintiffs,

:

:

:

PENNSYLVANIA DEPARTMENT

:

CORRECTIONS; JOHN WETZEL, Secretary, :

Pennsylvania Department of Corrections;

:

PAUL NOEL, Chief Medical Director,

:

Pennsylvania Department of Corrections;

:

RICH WENHOLD, Infection Control

:

Coordinator, Pennsylvania Department of

:

Corrections; CORRECT CARE SOLUTIONS; :

DR. JAY COWAN, Medical Director, Correct :

Care Solutions; DR. JOHN KEPHART,

:

Medical Director (former), SCI Smithfield;

:

DR. JAMES FROMMER; Medical Director, :

SCI Smithfield, WEXFORD HEALTH

:

SOURCES, INC.

:

:

Defendants.

:

Civil Action No. 15-3333

FIRST AMENDED CLASS ACTION COMPLAINT

INTRODUCTION

1. The Pennsylvania Department of Corrections (DOC), by policy and practice,

systemically denies necessary medical care for inmates diagnosed with Chronic Hepatitis C viral

infections, thereby placing them at substantial and unnecessary risk for severe illness and death.

Since 2014, with the approval by the Federal Drug Administration of

Direct

Acting Anti-

D

is available for persons with Hepatitis C, with no

adverse side-effects. Major medical associations, Medicare, the Veterans Administration, and

1

Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 2 of 21
private health insurance companies provide DAAD to all persons with chronic Hepatitis C. Yet, the DOC rations these drugs in an arbitrary manner, and refuses to provide DAAD treatment to over 98% of inmates with chronic Hepatitis C in the DOC. The denial of these drugs is based solely on their costs, and without any medical justification.
2. Plaintiffs Salvatore Chimenti, Daniel Leyva, and David Maldonado are incarcerated in the Pennsylvania Department of Corrections with serious health complications stemming from their Hepatitis C viral infections. The Defendants have refused to provide necessary medical treatment to Plaintiffs and others incarcerated in the DOC with Hepatitis C infections that is mandated by prevailing community medical standards and the Constitutions and laws of the United States and Pennsylvania. Plaintiffs bring this action on behalf of themselves and a class of similarly-situated plaintiffs, pursuant to 42 U.S.C. § 1983 and state laws against the DOC, prison officials, and medical providers for depriving them of their rights guaranteed by the Eighth Amendment of the United States Constitution, Article I, § 13 of the Pennsylvania Constitution, and Pennsylvania Law.
JURISDICTION AND VENUE 3. Plaintiff brings this action pursuant to 42 U.S.C. § 1983 and the Eighth Amendment of the United States Constitution, and 28 U.S.C. §§ 1331 and 1343. The Court has supplemental jurisdiction under 28 U.S.C 1367(a) to adjudicate the Pennsylvania state law and constitutional claims. 4. Venue is appropriate in this district pursuant to 28 U.S.C. 1391(g) since substantial events at issue in this litigation occurred in the Eastern District of Pennsylvania.
2

Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 3 of 21
PARTIES 5. Plaintiff Salvatore Chimenti is an adult individual currently incarcerated at the Pennsylvania State Correctional Institution at Smithfield (SCI Smithfield). Mr. Chimenti sues for injunctive and declaratory relief on behalf of himself and on behalf of a class of plaintiffs who are currently or will in the future be subject to Defendant DOC s discriminatory and unconstitutional policy for treating Hepatitis C infections. Mr. Chimenti also seeks money damages for the longstanding violations of his right to medical care. 6. Plaintiff Daniel Leyva is an adult individual currently incarcerated at the State Correctional Institution at Retreat (SCI Retreat). He sues for injunctive and declaratory relief on behalf of himself and on behalf of a class of plaintiffs who are currently or will in the future be subject to Defendant DOC s discriminatory and unconstitutional policy for treating Hepatitis C infections. 7. Plaintiff David Maldonado is an adult individual currently incarcerated at the State Correctional Institution at Graterford (SCI Graterford). He sues for injunctive and declaratory relief on behalf of himself and on behalf of a class of plaintiffs who are currently or will in the future be subject to Defendant DOC s discriminatory and unconstitutional policy for treating Hepatitis C infections. 8. Defendant Pennsylvania Department of Corrections (DOC) is an agency of the Commonwealth of Pennsylvania that operates SCI Smithfield, SCI Retreat, and SCI Graterford, among other correctional institutions. The DOC is responsible for providing adequate medical health services to and creating policies that ensure appropriate medical treatment to Plaintiffs and those similarly situated.
3

Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 4 of 21

9. Defendant John Wetzel is the Secretary of the DOC. He is responsible for all the

, including

providing appropriate medical treatment and the formulation of policies that ensure the provision

of that treatment to Plaintiffs and those similarly situated. He is sued in his individual and

official capacities. At all relevant times, Defendant Wetzel has acted and will continue to act

under color of state law.

10. Defendant Paul Noel is the Chief Medical Director of the DOC and has

responsibility in overseeing the delivery of medical services in the DOC, and in particular in

providing medical treatment for inmates with Hepatitis C. Dr. Noel serves on the DOC Hepatitis

C Treatment Committee that makes the final medical determination for inmates with Hepatitis C.

Defendant Noel is sued in his individual and official capacities. He has acted and will continue

to act under color of state law.

11. Defendant Rich Wenhold is the Infection Control Coordinator at the DOC and

serves on the DOC Hepatitis C Treatment Committee. He is sued in his official and individual

capacities. He has acted and will continue to act under color of state law.

12. Defendant Correct Care Solutions

is the current health care provider for

all DOC facilities. The principal office for Correct Care Solutions is in Nashville, Tennessee,

with an office as well in Pennsylvania. Correct Care Solutions began providing health care

services to the Pennsylvania DOC on September 1, 2014. At all relevant times, Correct Care

Solutions has acted and will act under the color of state law.

13. Defendant Jay Cowan is the statewide Medical Director for Defendant Correct

Care Solutions, the medical provider/vendor for medical services within the DOC. Defendant

4

Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 5 of 21

Cowan serves on the DOC Hepatitis C Treatment Committee, and has acted and will continue to

act under color of state law. He is sued in his individual and official capacities.

14. Dr. John Kephart is a physician and was the Medical Director at SCI Smithfield

during relevant time periods of treatment of the plaintiffs. He is sued in his official and

individual capacities, and acted under color of state law.

15. Dr. James Frommer is a physician and is the Medical Director at SCI Smithfield

during relevant time periods of treatment of the plaintiffs. He is sued in his official and

individual capacities and acted under color of state law.

16. Defendant Wexford Health Sources Inc. was the previous health care provider for

all DOC facilities. The principal office for Wexford Health Sources is in Pittsburgh,

Pennsylvania. At all relevant time, Defendant Wexford Health Sources has acted and will act

under the color of state law.

FACTS

The Hepatitis C Epidemic

17. Hepatitis C is a viral infection, primarily spread through contact with infected

blood that attacks the liver and causes hepatitis, or liver inflammation, which can significantly

impair

in digesting essential nutrients, filter toxins from the

blood, and prevent disease.

18. Hepatitis C infections are of multiple genotypes and can be of an acute or chronic

nature. An acute infection, a short-term illness, occurs within the first six months of exposure to

the virus and, for most persons exposed to the virus, leads to chronic Hepatitis C infection.

19. Chronic Hepatitis C infections are serious, long-term illnesses that can last

Hepatitis C is the leading cause of cirrhosis (irreversible scarring of

5

Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 6 of 21

liver tissue) and liver cancer and is the most common cause of liver transplants. Chronic

Hepatitis C infection can cause serious chronic liver disease, liver fibrosis (scarring of liver

tissue), and death, as well as extrahepatic conditions such as diabetes, heart disease, fatigue,

depression, muscle and nerve damage, nausea, and problems with concentration and memory.

For persons with chronic Hepatitis C, each day without treatment increases the likelihood of

these conditions.

20. Hepatitis C is the leading infectious disease killer in the United States, killing

nearly 20,000 persons annually of the more than five million persons with Hepatitis C (a death

rate greater than the next sixty infectious diseases combined).

21. Liver transplants are painful, carry a risk of significant complications, are nearly

impossible for prisoners to obtain, and result in lower recovery rates than treatment with direct-

acting antiviral drugs.

22. By not providing necessary medical care,

cause immediate and

substantial risks to Plaintiffs and those similarly situated with death and other irreparable harm

stemming from their chronic Hepatitis C infections. Plaintiffs and members of the proposed

class, which number more than 5,400 inmates, have suffered and will continue to suffer grave

and irreparable harm unless the Court orders Defendants to provide the safe and effective

treatment with direct-acting antiviral drugs as described below.

Standard of Care for Hepatitis C Infections

23. For many years, finding and establishing an effective and safe treatment for

Hepatitis C infections was a highly elusive goal. The standard treatment, which included the use

of interferon and ribavirin medications, failed to cure large numbers of patients and was

6

Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 7 of 21

associated with painful and other adverse side-effects, including psychiatric and autoimmune

disorders, flulike symptoms, and gastrointestinal distress.

24. Over the past three years, the approval by the Federal Drug Administration (FDA)

of new

DAAD, including Sovaldi, Olysio, and Harvoni, has revolutionized the

treatment module for Hepatitis C infections.

25. Sovaldi, Olysio, and Harvoni, properly administered, have no adverse side-effects

and are highly effective in creating a sustained viral response and a full cure of Hepatitis C

infection.

26. The DAAD treatment modules have very high cure rates (over 90% of patients

treated for Sovaldi and over 95% for Harvoni) and require a short treatment period of 8-12

weeks.

27. The standard of care in the community for Hepatitis C infections the use of the

DAAD is now well-established. These new treatment modules have been recommended for

treatment of all persons with Chronic Hepatitis C by the American Association for the Study of

,

Disease Control, Medicare, many medical systems, the Veterans Administration, and most

private medical insurers. No other treatments are recommended or in use for persons with

Chronic Hepatitis C.

Pennsylvania DOC Policy for Hepatitis C Infections

28. From 2013, when the FDA first approved the use of DAAD to the current date,

Defendants failed to promulgate and implement treatment policies or provide medical treatment

for all inmates with Chronic Hepatitis C infections consistent with medical and community

7

Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 8 of 21

standards, and specifically the Defendants failed to authorize treatment with the effective DAAD

for the vast majority of inmates with Chronic Hepatitis C.

29. The DOC has formulated a Hepatitis C medical care and treatment process

pursuant to the DOC

. The Protocol

establishes final policy and practices for Hepatitis C treatment for inmates, and creates a

rationing system for treatment of inmates with DAAD.

30. As formulated and implemented, the Protocol arbitrarily denies necessary,

appropriate, and constitutionally mandated DAAD treatment to over 98% of inmates with

Chronic Hepatitis C, in direct conflict with community health standards. Plaintiffs and members

of plaintiff class are thus denied drugs that would effectuate a full cure of their disease.

31. Chronic Hepatitis C is diagnosed on a fibrosis level scale of F-0 to F-4, with

levels F-0 and F-1 including persons with early stage chronic Hepatitis C, of whom over 70%, if

not treated with DAAD, will progress to serious fibrosis and, of that group, 30% will develop

cirrhosis of the liver. All persons with Chronic Hepatitis C risk liver cancer, liver failure,

diabetes, heart failure, kidney disease, and serious physical and mental pain and suffering.

32. As a consequence, Plaintiffs and all class members with Hepatitis C infections

have a substantially increased risk of continued Hepatitis C infection, liver disease, liver cancer,

cirrhosis, extra-hepatic diseases and conditions, and death. Defenda

D

forces Plaintiffs and the plaintiff class to endure chronic inflammatory disease, pain, fatigue,

increased risks of cancer, liver failure, heart attacks, and death, before any DAAD treatment is

provided.

33. There is no medical justification for a treatment module for Hepatitis C infection

that does not provide DAAD to all inmates with chronic Hepatitis C, except for those with very

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Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 9 of 21
short life expectancy or release dates less than three months from the start of DAAD treatment.
To the extent that DAAD treatment is not provided because of financial considerations, the
practice is unconstitutional and otherwise in violation of the United States Constitution, the
Pennsylvania Constitution, and Pennsylvania state law as they deny necessary and appropriate
medical care to Plaintiff and members of the class.
34. In Mumia Abu-Jamal v. Wetzel, 3:16-CV-2000, 2017 U.S. Dist. LEXIS 368 (M.D.
Pa. January 3, 2017), the court ruled that the Protocol in unconstitutional as written and applied,
and stated:
The Hepatitis C Protocol, in both how it is written and how it is implemented, bars those without vast fibrosis or cirrhosis from being approved for treatment with DAA medications. As such, the Hepatitis C Protocol presents a conscious disregard of a known risk that inmates with fibrosis, like Plaintiff, will suffer from hepatitis C related complications, continued liver scarring and damage progressing into cirrhosis, and from cirrhosis related complications such as ascites, portal hypertension, hepatic encephalopathy, and esophageal varicies.
The Hepatitis C Protocol deliberately delays treatment for Hepatitis C through the administration of DAA drugs such as Harvoni, Sovaldi, and Viekira Pak despite the knowledge of Defendants that sit on the Hepatitis C Treatment Committee: (1) that the aforesaid DAA medications will effect a cure of Hepatitis C in 90 to 95 percent of the cases that disease; and (2) that the substantial delay in treatment that is inherent in the current protocol is likely to reduce the efficacy of these medications and thereby prolong the suffering of those who have been diagnosed with chronic Hepatitis C and allow the progression of the disease to accelerate so that it presents a greater threat of cirrhosis, hepatocellular carcinoma, and death of the inmate with such disease.
Id. at *30-31 (internal numbering omitted)
Plaintiff Salvatore Chimenti
35. Mr. Chimenti entered the DOC in 1983, and is currently incarcerated at SCI
Smithfield.
36. In 1991, while Mr. Chimenti was housed at SCI Huntingdon, the medical staff
informed Mr. Chimenti that he had tested positive for Hepatitis C.
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37. Mr. Chimenti received interferon treatments from December 1, 1997 to March 18,

1998, but these treatments did not provide a cure for the disease.

38. In May 1998, a gastrointestinal specialist, Michael F. Gaugler, D.O.,

recommended consideration of a treatment module for Mr. Chimenti of interferon in

combination with ribavirin, and that treatment module was approved by the FDA in or about

June 1998.

39. The DOC took 18 months to develop a protocol from 1998 to 2000, and therefore,

Mr. Chimenti did not begin the combination treatment with interferon and ribavirin (combined

together and branded as Rebetron) until June 2000, but once again his condition did not improve

with this six-month treatment.

40. During this time while waiting for the Rebetron treatment for Hepatitis C, Mr.

thus reducing his chance of

responding positively to that treatment by 50 percent.

41. In 2011, after FDA approved a triple therapy treatment using boceprevir or

telaprevir in combination with interferon and ribavirin, Mr. Chimenti again sought to have his

Hepatitis C treated.

42. After waiting 10 months, Mr. Chimenti was treated with triple therapy at SCI

Forest from June 2012 through May 2013. He initially responded positively to the triple therapy,

but relapsed six months later in November 2013.

43. Mr. Chimenti now suffers from Stage 4 compensated cirrhosis with chronic liver

failure. His Model for End-Stage Liver Disease (

) score is 12. The MELD score is a

measure of mortality risk in patients with end-stage liver disease and is used as a disease severity

index to help prioritize allocation of organs for transplant.

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Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 11 of 21
44. In 2009, Dr. Abhinav Humar, Chief Liver Transplant Specialist from the University of Pittsburgh Medical Center was appointed by U.S. District Court Judge Vanaskie to
Humar recommended that Mr. Chimenti be assessed with ultrasounds and CT scans of his liver every six months, and that if
tologist for the possibility of a liver transplant.
45. Since November 2013, Defendants, including Dr. Kephart, Dr. Frommer, and Dr. Noel, continually denied and delayed the necessary treatment to track and halt the deleterious effects of Hepatitis C, including regular ultrasounds and CT scans, which are medically necessary for individuals with Stage 4 cirrhosis, and the provision of DAAD.
46. Defendants, including Kephart, Frommer, Noel, Correct Care Solutions, and Wexford Health Source, failed with deliberate indifference to have Mr. Chimenti seen or evaluated by a hepatologist or a gastroenterologist for proper treatment of his liver condition.
47. In late 2013, Mr. Chimenti began requesting treatment of his Hepatitis C infection with direct-acting antiviral drugs, but he has been denied and delayed this treatment by Defendants, even though the standard of community care at that time required that Mr. Chimenti be prescribed Sovadi with ribavirin, which has an over 90% cure rate.
48. In November 2014, CHCA Dreibelbis informe
49. In late 2014 and early 2015, emails were exchanged between Dr. Noel, Dr. Dean Rieger (Deputy Chief Clinical Officer of CCS), and Dr. Kephart (with others sometimes copied on the email, including Dr. Hochberg, Mr. Dreibelbis, and Mr. Oppman), discussing Mr.
11

Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 12 of 21

Chimenti s medical treatment, and deciding that Mr. Chimenti should merely be monitored and

that there was no urgency in providing the latest DAAD medication treatment.

50. In Dr. Kephart s role as the former Medical Director and in Dr. Frommer s

current role as the Medical Director at SCI Smithfield, they each review(ed) and approve(d) all

requests for referrals to outside providers and outside medical treatment for Mr. Chimenti, and

receive(d) and/or review(ed) many or all reports from those outside medical providers, including

those related to Mr. Chimenti s Hepatitis C, cirrhosis, and related conditions.

51. In the fall of

Defendants, and in

particular Defendant Dr. Frommer, insisted that Mr. Chimenti undergo a liver biopsy before

providing any further treatment or referring Mr. Chimenti to a hepatologist (and/or a transplant

hepatologist), even though a biopsy is no longer recommended as part of the standard of care due

to the risk of bleeding and seeding. While Mr. Chimenti initially declined the biopsy due to the

noted risks of such biopsy, he ultimately consented to a liver biopsy. However, subsequently

two separate radiologists on two occasions, in fact, determined that a liver biopsy would be too

dangerous for Mr. Chimenti, due to the location of the mass. The standard of care provides that

a patient can and should be evaluated for both DAAD and the possibility of liver cancer at the

same time.

52. In approximately March 2016, Mr. Chimenti had a meeting with numerous

medical staff, including Dr. Frommer, Mr. Dreibelbis, Dr. Dolphin, J. Hartman (RNS), and Mega

Pfiel (PAC), regarding his Hepatitis C and related medical conditions. At that time, the medical

personnel agreed to recommend DAAD treatment and referral to a hepatologist (specifically a

transplant hepatologist), and upon information and belief, this recommendation and request was

sent to Central Office but denied.

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Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 13 of 21
53. As Defendants delayed and denied providing DAAD to Mr. Chimenti, he suffered from symptoms of chronic Hepatitis C, cirrhosis, and a failing liver, including but not limited to hypertension, jaundice, confusion, bad odor, and poor laboratory test results measuring bilirubin, enzyme, and platelet levels.
54. Despite Mr. Chimenti having stage 4 cirrhosis, the most advanced stage, it was not until in or around July 2016 that he was referred to a hepatologist for an evaluation since he had been returned to SCI Smithfield from SCI Forest in 2013, and it was not until October 2016 that he finally received the DAAD treatment.
55. Mr. Chimenti has fully grieved the denial of his request for this form of medical treatment, as well as the lack of any treatment for his Hepatitis C or cirrhosis.
56. As a result of Defendant denial and continual delay of the necessary medical treatment, Mr. Chimenti continued to suffer from chronic Hepatitis C infection, advanced cirrhosis, and the related risks of liver failure and death, and physical and emotional pain and suffering.
57. Furthermore, his liver continued to deteriorate and a mass developed in his liver during the time period of the denial and delay of necessary medical treatment for his Hepatitis C, and is still at risk for needing a liver transplant.
58. The refusal, with deliberate indifference, of Defendants to provide Mr. Chimenti and other class members with Hepatitis C infections with access to the necessary and appropriate DAAD and other medical services for the treatment of their Hepatitis C infections constitutes a violation of the Eight Amendment, the Pennsylvania Constitution, and Pennsylvania state law.
13

Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 14 of 21

Plaintiff Daniel Leyva

59. Plaintiff Daniel Leyva is currently incarcerated at SCI Retreat.

60. Mr. Leyva was diagnosed with Hepatitis C in 2001 or 2002 while he was

incarcerated at SCI Albion.

61. Previously he had been treated with interferon and ribavirin, but it was

unsuccessful in treating his Hepatitis C infection.

62. Mr. Leyva has Hepatitis genotype 1 and recent lab results show that he has

elevated or high levels of the Hepatitis C virus.

63. Mr. Leyva requested to be provided the latest direct-acting antiviral drug

treatment, but the doctor informed him that it cost too much.

64. Mr. Leyva filed a grievance requesting to be provided with the latest direct-acting

antiviral drug treatment and fully exhausted his administrative remedies.

65. In the DOC response, Joseph Mataloni, Corrections Health Care Administrator at

SCI

-evaluating our treatment protocol for Hepatitis C given the

new guidance issued by the American Association of Liver Diseases (AASLD) and the

66. Mr. Leyva also received a response from Christopher H. Oppman, Director, Bureau of Health Care Services, who also informed him that the DOC and BCHS are reevaluating their treatment protocol.
67. Mr. Leyva currently experiences symptoms of Hepatitis C, including pain, fatigue, and his eyes are jaundiced and requires immediate treatment to prevent any further liver damage.

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Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 15 of 21

68. Mr. Leyva still has not received DAAD or proper medical treatment for his

chronic Hepatitis C.

Plaintiff David Maldonado

69. Plaintiff David Maldonado has been incarcerated in the DOC since 1980, and has

been incarcerated at SCI Graterford since 1995.

70. Mr. Maldonado was diagnosed with Hepatitis C in 1997.

71. Mr. Maldonado was treated with interferon and ribavirin in 2001, but the

treatment was unsuccessful.

72. After undergoing a liver biopsy which revealed that Mr. Maldonado was between

Stage 1 and Stage 2 liver fibrosis, Mr. Maldonado was transferred to SCI Forest in June 2013 to

receive the triple therapy of interferon and ribavirin with boceprevir. While there was some

initial success in reducing Mr.

viral load, the treatment failed after six months in

December 2013. Mr. Maldonado returned to SCI Graterford in February 2014.

73. Mr. Maldonado requested the direct-acting antiviral drug treatment from the

medical staff and Medical Director Weiner, but was informed by the Bureau of Health Care

Services that a new protocol was being developed.

74. Joseph

by the

DOC, BHCS. When the protols [sic] are extablished [sic] and the drug is approved there will be

75. was

-evaluating our treatment protocol for Hepatitis C given the

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Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 16 of 21

new guidance issued by the American Association of Liver Diseases and the Infectious Diseases

76. Mr. Maldonado continues to suffer from elevated liver enzyme levels beyond the normal range,
77. Mr. Maldonado fibrosis requires immediate treatment to prevent any further liver damage or liver failure.
78. Mr. Maldonado filed grievances requesting to be provided proper medical treatment for Hepatitis C, including the latest direct-acting antiviral drug treatment, and has fully exhausted his administrative remedies.
79. Mr. Leyva still has not received DAAD or proper medical treatment for his chronic Hepatitis C.
CLASS ACTION ALLEGATIONS 80. Plaintiffs bring this suit as a class action on behalf of himself and all others

81. Plaintiffs seek to represent the following class on claims for declaratory and injunctive relief:

All persons who are currently incarcerated in a Pennsylvania Department of Corrections facility with a diagnosed condition of Chronic Hepatitis C, and who have at least twelve (12) weeks or more remaining to serve on their sentences, and who have a life expectancy of over one year.

82. As a result of D

the Class, members of the Class are or will be subjected to cruel and unusual punishment and

deprived of their federal and state constitutional and statutory rights. Plaintiffs seek declaratory

and injunctive relief to remedy D

illegal and unconstitutional actions, policies, and

practices.

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Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 17 of 21

83. The requirements of Rules 23(a) and 23(b)(2) are satisfied by this class action.

84. The class includes no fewer than 5,400 inmates in the Pennsylvania DOC, who

are geographically dispersed throughout the Commonwealth of Pennsylvania. The number of

persons who are members of the Class described above are so numerous that joinder of all

members in one action is impracticable.

85. Questions of law and fact that are common to the entire Class predominate over

individual questions because the actions of Defendants complained of herein were generally

applicable to the entire class. These legal and factual questions include, but are not limited to:

a. Whether the treatment regimens utilizing DAAD are the proper, necessary

and standard course of treatment in the medical community;

b. Whether denial of treatment regimens utilizing DAAD drugs to the Class

will cause injury to the Class members, including unnecessary pain and

suffering, chronic illness, and death; and

c. Whether D

Hepatitis C current treatment policy, which denies

necessary DAAD treatment for many inmates with Chronic Hepatitis C

infections violates the Eighth Amendment to the U.S. Constitution and

Article I § 13 of the Pennsylvania Constitution.

86. Plaintiffs claims are typical of the members of the Class because Plaintiffs and

all Class Members were injured by the same wrongful policy and practices of Defendants as

described in this Complaint. Plaintiffs claims arise from the same practices and course of

conduct that give rise to the claims of the Class members, and are based on the same legal

theories.

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Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 18 of 21
87. Plaintiffs will fairly and adequately protect the interests of the Class. Plaintiffs have no interests that are contrary to or in conflict with those of the Class they seek to represent. Plaintiffs are represented by competent and skilled counsel whose interests are fully aligned with the interests of the Class.
88. Relief concerning Plaintiffs rights under the laws herein alleged and with respect to the Class would be proper. Defendants have acted or refused to act on grounds generally applicable to the Class, thereby making appropriate final injunctive relief or corresponding declaratory relief with regard to Class Members as a whole and certification of the Class under Rule 23(b)(2) proper.
CLAIMS COUNT I Deprivation of Eighth Amendment Right to Medical Care 89. Plaintiffs incorporate paragraphs 1 through 88 of this Complaint as if fully set forth herein. 90. Defendants acts and omissions in failing to provide adequate medical care constitute a deliberate indifference to the serious medical needs of prisoners infected with Hepatitis C, thereby establishing a violation of the Eighth Amendment to the United States Constitution.
COUNT II Deprivation of Right Not to Undergo Cruel and Unusual Punishment Under the
Pennsylvania Constitution 91. Plaintiffs incorporate paragraphs 1 through 88 of this Complaint as if fully set forth herein. 92. Defendants acts and omissions in failing to provide adequate medical care constitute a deliberate indifference to the serious medical needs of prisoners infected with
18

Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 19 of 21

Hepatitis C thereby establishing a violation of Article I, § 13 of the Pennsylvania Constitution

and its prohibition against the infliction of cruel punishments.

COUNT III Negligence Medical Malpractice

93. Plaintiff Chimenti incorporates paragraphs 1 through 88 of this Complaint as if

fully set herein.

94. At all relevant times, the individual Defendants and corporate Defendants had a

duty to act in accordance with the standard of care required of medical care professionals and to

act as a reasonable corporation would under the same or similar circumstances, they breached

that duty in failing to provide the standard of care necessary for individuals infected with

Hepatitis C, and

injuries were the direct, legal and proximate result of

Defendants negligence.

COUNT IV Negligence Medical Malpractice and Vicarious Liability 95. Plaintiff Chimenti incorporates paragraphs 1 through 88 of this Complaint as if fully set herein. 96. Defendant Correct Care Solutions and Wexford Health Sources are vicariously liable to plaintiff Chimenti for the negligent acts commissions, or omissions of its employees and/or agents, who at all times relevant hereto acted on behalf of Correct Care Solutions and/or Wexford Health Sources and within the scope of their employment, under the doctrines of respondeat superior and ostensible agency.

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Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 20 of 21

RELIEF

WHEREFORE Plaintiffs Salvatore Chimenti, Daniel Leyva, and David

Maldonado respectfully requests the following relief:

97.

For the named plaintiffs and members of the plaintiff Class, a Declaratory

Judgment that Defendant Pennsylvania Department of Corrections current policy for Hepatitis C

treatment violates the Eighth Amendment of the United States Constitution, and Article I § 13 of

the Pennsylvania Constitution;

98.

For the named plaintiffs and members of the plaintiff Class, injunctive relief

ordering that Defendant Pennsylvania Department of Corrections (a) formulate and implement a

Hepatitis C treatment policy that meets the community standards of care for patients with

Hepatitis C, (b) that members of the Class be treated with medically necessary and the

appropriate direct-acting antiviral drugs based on individual medical testing and medical

evalu

epatitis C status, and (c) that members of the class

receive ongoing monitoring and medical care per the standard of care for their individual level of

liver fibrosis and cirrhosis, including but not limited to appropriate access to and evaluation by a

hepatologist and assessment regarding their need for partial or full liver transplant.

99.

Compensatory damages for Salvatore Chimenti;

100.

Punitive damages for Salvatore Chimenti;

101.

Such other relief the Court deems just and equitable.

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Case 2:15-cv-03333-JP Document 50 Filed 02/03/17 Page 21 of 21

DATE: February 1, 2017

Respectfully submitted,
/s/ David Rudovsky David Rudovsky, PA Attorney No. 15168 Kairys, Rudovsky, Messing & Feinberg LLP 718 Arch Street, Suite 501S Philadelphia, PA 19106 (215) 925-4400
/s/ Su Ming Yeh Su Ming Yeh, PA Attorney No. 95111 Angus R. Love, PA Attorney No. 22392 Pennsylvania Institutional Law Project 718 Arch Street, Suite 304S Philadelphia, PA 19106 (215) 925-2966
/s/ Stephen Brown Stephen Brown, PA Attorney No. 27829 Christine Levin, PA Attorney No. 37807 Rose Marie Wong, Attorney No. 320602 Dechert LLP Cira Centre 2929 Arch Street Philadelphia, PA 19104 (215) 994-2404

21

 
 Case 2:15-cv-03333-JP Document 90 Filed 08/08/17 Page 1 of 30

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

SALVATORE CHIMENTI, ET AL.

:

:

v.

:

:

PENNSYLVANIA DEPARTMENT

:

OF CORRECTIONS, ET AL.

:

CIVIL ACTION NO. 15-3333

MEMORANDUM

Padova, J.

August 7, 2017

Plaintiffs have brought this class action lawsuit against the Pennsylvania Department of

Corrections (the “DOC”) and officials and employees thereof (collectively the “DOC

Defendants”), and two companies that have contracted to provide medical services for the DOC

and officials and employees thereof (collectively the “Medical Defendants”), asserting claims

regarding the medical care provided to DOC inmates who have been diagnosed with Hepatitis C.

Before the Court are two Motions to Dismiss the Amended Complaint, one brought by the DOC

Defendants and the other by the Medical Defendants. For the following reasons, each Motion is

granted in part and denied in part.

I. FACTUAL BACKGROUND

The Amended Complaint alleges the following facts. Plaintiffs Salvatore Chimenti,

Daniel Leyva, and David Maldonado are all incarcerated in DOC facilities and all suffer from

Hepatitis C. (Am. Compl. ¶ 2.) Defendant John Wetzel is the Secretary of the DOC, Defendant

Paul Noel is the Chief Medical Director of the DOC, and Defendant Rich Wenhold is the

Infection Control Coordinator at the DOC; both Noel and Wenhold serve on the DOC’s Hepatitis

C Treatment Committee. (Id. ¶¶ 9-11.) Defendant Correct Care Solutions began providing

health care services for DOC facilities on September 1, 2014, and is the current health care

Case 2:15-cv-03333-JP Document 90 Filed 08/08/17 Page 2 of 30
provider for all DOC facilities. (Id. ¶ 12.) Defendant Jay Cowan is the statewide Medical Director for Correct Care Solutions and serves on the DOC’s Hepatitis C Treatment Committee. (Id. ¶ 13.) Defendant Dr. John Kephart was the Medical Director at SCI Smithfield during relevant time periods. (Id. ¶ 14.) Defendant Dr. James Frommer is the current Medical Director at SCI Smithfield. (Id. ¶ 15.) Defendant Wexford Health Sources, Inc. was the health care provider for all DOC facilities prior to Correct Care Solutions. (Id. ¶ 16.)
A. Hepatitis C and Its Treatments Hepatitis C is a viral infection that is primarily spread through contact with infected blood. (Id. ¶ 17.) Hepatitis C attacks the liver and causes hepatitis (inflammation of the liver), “which can significantly impair the liver’s ability to assist the body in digesting essential nutrients, filter toxins from the blood, and prevent disease.” (Id.) Hepatitis C can be acute or chronic. (Id. ¶ 18.) Acute Hepatitis C is a short-term illness that occurs within the first six months of exposure to the virus and can lead to Chronic Hepatitis C. (Id.) Chronic Hepatitis C is a “long-term illness[] that can last throughout a person’s life” and is “the leading cause of cirrhosis (irreversible scarring of liver tissue) and liver cancer and is the most common cause of liver transplants.” (Id. ¶ 19.) Chronic Hepatitis C can also lead to “chronic liver disease, liver fibrosis (scarring of liver tissue),” liver cancer, liver failure, diabetes, heart failure, kidney disease, and death. (Id. ¶¶ 19, 31.) There are more than 5400 DOC inmates in the proposed class who have suffered and will continue to “suffer grave and irreparable harm unless the Court orders Defendants to provide [them with] safe and effective treatment with direct-acting antiviral drugs.” (Id. ¶ 22.) In the past, the standard treatment for Hepatitis C infections, “which included the use of interferon and ribavirin medications, failed to cure large numbers of patients and was associated
2

Case 2:15-cv-03333-JP Document 90 Filed 08/08/17 Page 3 of 30
with painful and other adverse side-effects, including psychiatric and autoimmune disorders, flulike symptoms, and gastrointestinal distress.” (Id. ¶ 23.) Over the past three years, the Federal Drug Administration (“FDA”) has approved new direct-acting antiviral drugs (“DAADs”), including Sovaldi, Olysio, and Harvoni, to treat Hepatitis C infections. (Id. ¶ 24.) Sovaldi, Olysio, and Harvoni, when properly administered, “have no adverse side-effects and are highly effective in creating a sustained viral response and a full cure of Hepatitis C infection[s].” (Id. ¶ 25.) Treatment with DAADs for 8-12 weeks cures more than 90% of patients and has become the standard of care in the community for Hepatitis C. (Id. ¶¶ 26-27.) The following entities have recommended DAADs for the treatment of all persons with Chronic Hepatitis C: the American Association for the Study of Liver Diseases (“AASLD”), the Infectious Diseases Society of America (“IDSA”), the Center for Disease Control, Medicare, the Veterans Administration, and most private insurers. No other treatments are currently recommended for the treatment of Chronic Hepatitis C. (Id.)
From the time the FDA approved DAADs for the treatment of Hepatitis C in 2013 until November 2016, Defendants failed to develop treatment policies for the use of DAADs and also failed to provide treatment using DAADs to “the vast majority of inmates with Chronic Hepatitis C.” (Id. ¶ 28.) In November 2016, the DOC issued a Hepatitis C Protocol that established the DOC’s final policy and practices for the treatment of inmates with Hepatitis C and created a rationing system for the treatment of inmates using DAADs.1 (Id. ¶ 29.) However, the Protocol “arbitrarily denies necessary, appropriate, and constitutionally mandated DAAD treatment to
1 Plaintiffs attached a copy of the Hepatitis C Protocol as Exhibit A to their Joint Opposition to Defendants’ Motions to Dismiss. We may consider this document in the context of the Motions to Dismiss because it is undisputedly authentic and Plaintiffs’ claims rely on this document. See Mayer v. Belichick, 605 F.3d 223, 230 (3d Cir. 2010) (citing Pension Benefit Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir. 1993)).
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Case 2:15-cv-03333-JP Document 90 Filed 08/08/17 Page 4 of 30
over 98% of inmates with Chronic Hepatitis C, in direct conflict with community health standards.” (Id. ¶ 30.) Plaintiffs and members of the class have thus been denied treatment with drugs that would cure their Chronic Hepatitis C. (Id.)
“Chronic Hepatitis C is diagnosed on a fibrosis level scale of F-0 to F-4, with levels F-0 and F-1 including persons with early stage chronic Hepatitis C, of whom over 70%, if not treated with DAAD[s], will progress to serious fibrosis and, of that group, 30% will develop cirrhosis of the liver.” (Id. ¶ 31.) Defendants’ system of rationing of DAADs means that Plaintiffs and the members of the class they seek to represent will “endure chronic inflammatory disease, pain, fatigue, increased risks of cancer, liver failure, heart attacks, and death, before any DAAD treatment is provided.” (Id. ¶ 32.) There is no medical justification for the failure to treat all inmates with Chronic Hepatitis C with DAADs, except for those inmates who have very short life expectancies or release dates less than three months from the start of treatment. (Id. ¶ 33.)
B. The Plaintiffs Chimenti has been incarcerated by the DOC since 1983 and is currently held at the State Correctional Institute (“SCI”) at Smithfield (“SCI Smithfield”). (Id. ¶¶ 5, 35.) He was diagnosed with Hepatitis C in 1991. (Id. ¶ 36.) He has received different treatments from the DOC since that time, but has not been cured and currently suffers from “Stage 4 compensated cirrhosis with chronic liver failure.” (Id. ¶¶ 37-43.) In 2009, the Chief Liver Transplant Specialist from the University of Pittsburgh Medical Center recommended that Chimenti be evaluated for a liver transplant if his Model for End-Stage Liver Disease (“MELD”) score rose above 10. (Id. ¶ 44.) His MELD score is currently 12.2 (Id. ¶ 43.)
2 “The MELD score is a measure of mortality risk in patients with end-stage liver disease and is used as a disease severity index to prioritize allocations of organs for transplant.” (Am. Compl. ¶ 43)
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In late 2013, Chimenti began requesting treatment with DAADs, but Defendants denied that treatment for approximately three years. (Id. ¶¶ 47-48, 54.) In late 2014 and early 2015, emails were exchanged between Dr. Noel, Dr. Dean Rieger (Deputy Chief Clinical Officer of Correct Care Solutions), and Dr. Kephart, discussing Chimenti’s medical treatment. (Id. ¶ 49.) They decided that Chimenti should only be monitored and that there was no urgent need to treat him with DAADs. (Id.) “In the fall of 2015, a mass was discovered in Chimenti’s liver.” (Id. ¶ 51.) Defendants, particularly Dr. Frommer, “insisted that Chimenti undergo a liver biopsy before providing any further treatment or referring Mr. Chimenti to a hepatologist . . . even though a biopsy is . . . [not] part of the standard of care due to the risk of bleeding and seeding.” (Id.) Chimenti ultimately consented to undergo the biopsy, although two different radiologists subsequently determined that a liver biopsy would be too dangerous due to the location of the mass. (Id.) In March 2016, Chimenti had a meeting with medical staff, including Dr. Frommer, regarding his Chronic Hepatitis C and related medical conditions. (Id. ¶ 52.) The medical staff agreed to recommend that Chimenti be treated with DAADs and referred to a transplant hepatologist. (Id.) However, this recommendation was denied by the DOC. (Id.) While Defendants delayed and denied his requests for treatment with DAADs, Chimenti suffered from the symptoms of Chronic Hepatitis C, including “cirrhosis, and a failing liver, . . . hypertension, jaundice, confusion, bad odor, and poor laboratory test results.” (Id. ¶ 53.) Even though Chimenti had stage 4 cirrhosis (the most advanced stage), he was not referred to a hepatologist for an evaluation until July 2016 and was not treated with DAADs until October 2016. (Id. ¶ 54.) As a result of Defendants’ denial and delay of necessary medical treatment, Chimenti continued to suffer from Chronic Hepatitis C, advanced cirrhosis, the risks of liver failure and death, and physical and emotional pain and suffering. (Id. ¶ 56.) Additionally, he suffered from
5

Case 2:15-cv-03333-JP Document 90 Filed 08/08/17 Page 6 of 30
further deterioration of the condition of his liver during the time he was waiting to be treated with DAADs, to the point that a mass developed in his liver, and he may still need a liver transplant. Chimenti was finally treated with DAADs in October 2016. (Id. ¶ 57.)
Leyva was diagnosed with Hepatitis C in 2001 or 2002, while he was incarcerated at SCI Albion. (Id. ¶ 60.) He is presently incarcerated at SCI Retreat. (Id. ¶ 6.) He has been treated with interferon and ribavirin, but those drugs did not cure his infection. (Id. ¶ 61.) He has asked to be treated with DAADs, but was informed by his doctor that the treatment is too costly. (Id. ¶¶ 63, 65-66.) Leyva experiences pain, fatigue, and jaundice because of his Hepatitis C and requires treatment to prevent further liver damage. (Id. ¶ 67.) He has not yet received treatment with DAADs. (Id. ¶ 68.)
Maldonado has been incarcerated by the DOC since 1980 and was diagnosed with Hepatitis C in 1997. (Id. ¶¶ 69-70.) He is presently incarcerated at SCI Graterford). (Id. ¶ 7.) He was unsuccessfully treated for his Hepatitis C in 2001 and 2013. (Id. ¶¶ 71-72.) He has requested treatment with DAADs, but his request was denied on the ground that the DOC was developing a new protocol for treatment of Hepatitis C. (Id. ¶¶ 73-75.) As a result of his Chronic Hepatitis C, Maldonado suffers from elevated liver enzyme levels and also suffers from fibrosis that requires immediate treatment. (Id. ¶¶ 76-77.)
C. The Putative Class Plaintiffs seek to represent the following class: All persons who are currently incarcerated in a Pennsylvania Department of Corrections facility with a diagnosed condition of Chronic Hepatitis C, and who have at least twelve (12) weeks or more remaining to serve on their sentences, and who have a life expectancy of over one year. (Id. ¶ 81.) The class includes 5400 inmates in the DOC who are geographically dispersed throughout Pennsylvania. (Id. ¶ 84.) Plaintiffs believe that the following issues are common to
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the entire Class: (a) whether treatment with DAADs is the appropriate course of treatment; (b) whether denial of DAADs will injure class members; and (c) whether Defendants’ Hepatitis C treatment policy violates the Eighth Amendment and Article I, Section 13 of the Pennsylvania Constitution. (Id. ¶ 85.)
Plaintiffs assert four claims for relief. Count I asserts a claim for violation of Plaintiffs’ Eighth Amendment right to receive medical care; Count II asserts a claim for violation of Article I, Section 13 of the Pennsylvania Constitution; Count III asserts a claim for medical malpractice on behalf of Chimenti; and Count IV asserts a claim against Correct Care Solutions and Wexford for medical malpractice on behalf of Chimenti. Plaintiffs seek an injunction ordering the DOC to:
(a) formulate and implement a Hepatitis C treatment policy that meets the community standards of care for patients with Hepatitis C, (b) that members of the Class be treated with medically necessary and the appropriate direct-acting antiviral drugs based on individual medical testing and medical evaluation regarding each individual’s Hepatitis C status, and (c) that members of the class receive ongoing monitoring and medical care per the standard of care for their individual level of liver fibrosis and cirrhosis, including but not limited to appropriate access to and evaluation by a hepatologist and assessment regarding their need for partial or full liver transplant. (Id. ¶ 98.) Plaintiffs also seek compensatory and punitive damages for Chimenti, reasonable attorney’s fees and costs, and such other relief as the Court deems just and equitable. (Id. ¶¶ 99102.) The DOC Defendants have moved to dismiss all claims against the DOC and Rich Wenhold, to dismiss Count I in its entirety, to dismiss Count II to the extent that it requests an award of monetary damages for violation of Article I, Section 13 of the Pennsylvania Constitution, and to dismiss Count III to the extent that it asserts a claim for medical malpractice against Secretary Wetzel. The Medical Defendants have moved to dismiss Count I in its entirety
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and Count II to the extent that it requests an award of monetary damages for Violation of Article I, Section 13 of the Pennsylvania Constitution. The Medical Defendants have not moved to dismiss Counts III and IV. We held a Hearing on the Motion to Dismiss on April 4, 2017. During that Hearing, Plaintiffs agreed to dismiss all of their claims against the DOC and Defendant Rich Wenhold, and those claims are, accordingly, dismissed. Plaintiffs also agreed to dismiss Count II to the extent that it seeks an award of monetary damages and agreed to limit this claim to a request for injunctive relief against Secretary Wetzel. We therefore dismiss Count II except to the extent that it seeks injunctive relief against Secretary Wetzel. Plaintiffs further agreed to dismiss Count III as against Secretary Wetzel and we therefore dismiss Count III as against Secretary Wetzel. During the April 4, 2017 Hearing, Plaintiffs also agreed to dismiss their claim for injunctive relief in Count I against Wexford and Dr. Kephart and agreed to dismiss their claim for injunctive relief against Dr. Frommer after he leaves his position as the Medical Director of SCI Smithfield. Consequently, we also dismiss Plaintiffs’ request for injunctive relief in Count I against Wexford, Dr. Kephart, and Dr. Frommer (as of the date that he leaves his position at SCI Smithfield). We therefore analyze the Motions to Dismiss only as to the remaining claims asserted in Count I of the Amended Complaint. II. LEGAL STANDARD
Both the DOC Defendants and the Medical Defendants have moved to dismiss the Amended Complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). When considering a motion to dismiss pursuant to Rule 12(b)(6), we “consider only the complaint, exhibits attached to the complaint, [and] matters of public record, as well as undisputedly authentic documents if the complainant’s claims are based upon these documents.” Mayer v. Belichick, 605 F.3d 223, 230 (3d Cir. 2010) (citing Pension Benefit Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d
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1192, 1196 (3d Cir. 1993)). We take the factual allegations of the complaint as true and “construe the complaint in the light most favorable to the plaintiff.” Carpenters Health v. Management Resource Systems, Inc., 837 F.3d 378, 382 (3d Cir. 2016) (citing Phillips v. Cty. of Allegheny, 515 F.3d 224, 233 (3d Cir. 2008)). Legal conclusions, however, receive no deference, as the court is “‘not bound to accept as true a legal conclusion couched as a factual allegation.’” Wood v. Moss, 134 S. Ct. 2056, 2065 n.5 (2014) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)).
A plaintiff’s pleading obligation is to set forth “‘a short and plain statement of the claim,’” which gives “‘the defendant fair notice of what the . . . claim is and the grounds upon which it rests.’” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (alteration in original) (quoting Fed. R. Civ. P. 8(a)(2), and Conley v. Gibson, 355 U.S. 41, 47 (1957)). The complaint must contain “‘sufficient factual matter to show that the claim is facially plausible,’ thus enabling ‘the court to draw the reasonable inference that the defendant is liable for [the] misconduct alleged.’” Warren Gen. Hosp. v. Amgen, Inc., 643 F.3d 77, 84 (3d Cir. 2011) (quoting Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009)). “The plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Iqbal, 556 U.S. at 678 (citing Twombly, 550 U.S. at 556). “The plausibility determination is ‘a context-specific task that requires the reviewing court to draw on its judicial experience and common sense.’” Connelly v. Lane Constr. Corp., 809 F.3d 780, 786-87 (quoting Iqbal, 556 U.S. at 679). In the end, we will grant a motion to dismiss brought pursuant to Rule 12(b)(6) if the factual allegations in the complaint are not sufficient “‘to raise a right to relief above the speculative level.’” W. Run Student Hous. Assocs., LLC v. Huntington Nat’l Bank, 712 F.3d 165, 169 (3d Cir. 2013) (quoting Twombly, 550 U.S. at 555).
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III. DISCUSSION Count I of the Amended Complaint asserts a claim against all Defendants pursuant to 42
U.S.C. § 1983 for violation of Plaintiffs’ rights under the Eighth Amendment based on the denial of medical care for their Chronic Hepatitis C. Section 1983 provides, in pertinent part, as follows:
Every person who, under color of any statute, ordinance, regulation, custom, or usage, of any State or Territory or the District of Columbia, subjects, or causes to be subjected, any citizen of the United States or other person within the jurisdiction thereof to the deprivation of any rights, privileges, or immunities secured by the Constitution and laws, shall be liable to the party injured in an action at law, suit in equity, or other proper proceeding for redress . . . . 42 U.S.C. § 1983. “Section 1983 provides remedies for deprivations of rights established in the Constitution or federal laws. It does not, by its own terms, create substantive rights.” Kaucher v. Cnty. of Bucks, 455 F.3d 418, 423 (3d Cir. 2006) (footnote omitted) (citing Baker v. McCollan, 443 U.S. 137, 145 n.3 (1979)). Consequently, in order to state a claim for relief pursuant to § 1983, “a plaintiff must demonstrate the defendant, acting under color of state law, deprived him or her of a right secured by the Constitution or the laws of the United States.” Id. (citing Am. Mfrs. Mut. Ins. Co. v. Sullivan, 526 U.S. 40, 49-50 (1999), and Mark v. Borough of Hatboro, 51 F.3d 1137, 1141 (3d Cir. 1995)). Count I alleges that the Defendants’ “acts and omissions in failing to provide adequate medical care constitute a deliberate indifference to the serious medical needs of prisoners infected with Hepatitis C, thereby establishing a violation of the Eighth Amendment to the United States Constitution.” (Am. Compl. ¶ 90.) The Eighth Amendment’s right to be free from cruel and unusual punishment, which applies to the states via the Fourteenth Amendment, Robinson v. California, 370 U.S. 660, 666 (1962), “imposes duties on [prison] officials, who must . . . ensure that inmates receive . . . medical care, and must ‘take reasonable measures to
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guarantee the safety of the inmates.’” Farmer v. Brennan, 511 U.S. 825, 832 (1994) (quoting Hudson v. Palmer, 468 U.S. 517, 526-27 (1984) (remaining citations omitted)). To state a claim under the Eighth Amendment for denial of medical care, a plaintiff must plausibly allege that a defendant showed “[1] deliberate indifference to [2] serious medical needs of [a] prisoner[ ].” Estelle v. Gamble, 429 U.S. 97, 104 (1976) (quotation omitted). Courts have consistently held that “mere allegations of malpractice” are not sufficient to allege “deliberate indifference.” Id. at 106 n.14 (citations omitted).
“Deliberate indifference can be shown by a prison official ‘intentionally denying or delaying access to medical care or intentionally interfering with the treatment once prescribed.’” Rhines v. Bledsoe, 388 F. App’x 225, 227 (3d Cir. 2010) (quoting Estelle, 429 U.S. at 104–05). “A medical need is serious if it ‘has been diagnosed by a physician as requiring treatment or one that is so obvious that a lay person would easily recognize the necessity for a doctor’s attention.’” Id. (quoting Monmouth Cnty. Corr. Inst. Inmates v. Lanzaro, 834 F.2d 326, 347 (3d Cir. 1987)). Moreover, “to be considered ‘serious,’” the medical need must be such that “‘a failure to treat can be expected to lead to substantial and unnecessary suffering, injury, or death.’” Tsakonas v. Cicchi, 308 F. App’x 628, 632 (3d Cir. 2009) (quoting Colburn v. Upper Darby Twp., 946 F.2d 1017, 2023 (3d Cir. 1991)).
A prison official acts with deliberate indifference to a serious medical need “when he knows of and disregards an excessive risk to inmate health or safety.” Brown v. Thomas, 172 F. App’x 446, 450 (3d Cir. 2006) (citing Farmer, 511 U.S. at 837). “The official must be aware of the facts from which an inference could be drawn that a substantial risk of serious harm exists, and he must also draw the inference.” Id. (citing Farmer, 511 U.S. at 837). Given these prerequisites to a valid constitutional claim based on deliberate indifference, factual allegations
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suggesting only an “‘ordinary lack of due care for the prisoner’s interests or safety’” will not suffice to meet the pleading requirements for deliberate indifference under the Eighth Amendment. Farmer, 511 U.S. at 835 (quoting Whitley v. Albers, 475 U.S. 312, 319 (1986)).
A. The Individual DOC Defendants The individual DOC Defendants argue that Count I fails to state a claim against them upon which relief can be granted because the Amended Complaint does not allege facts that would establish that they were deliberately indifferent to the Plaintiffs’ serious medical needs. They maintain that Count I is based on allegations that they considered cost in deciding which inmates with Hepatitis C would be treated with DAADs and that the inmates with Chronic Hepatitis C would receive treatment with DAADs if they were being treated outside of the prison system. They further assert that the consideration of costs in deciding appropriate medical treatment cannot, as a matter of law, constitute deliberate indifference. They also contend that allegations that they deviated from community standards of care amount to mere disagreements with Plaintiffs’ medical treatments that do not rise to the level of deliberate indifference to Plaintiffs’ serious medical needs. The individual DOC Defendants also contend that the claim for monetary damages contained in Count I should be dismissed because they have qualified immunity with respect to such a claim.
1. Costs The Amended Complaint alleges that the DOC systematically denies treatment with DAADs to inmates with Chronic Hepatitis C. (Am. Compl. ¶ 1.) The Amended Complaint further alleges that, while “[m]ajor medical associations, Medicare, the Veterans Administration, and private health insurance companies provide DAAD[s] to all persons with Chronic Hepatitis C,” the DOC “refuses to provide treatment with DAADs to more than 98% of inmates with
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[C]hronic Hepatitis C” solely because of the cost of these drugs. (Id.) The individual DOC Defendants argue that the allegation that they have adopted a policy for treatment of inmates with Chronic Hepatitis C that rations DAADs and restricts treatment with those drugs solely because of the cost of those drugs3 cannot support a plausible claim that they are deliberately indifferent to the Plaintiffs’ serious medical needs because “the mere assertion that defendants considered cost in treating [plaintiffs’ medical conditions] does not suffice to state a claim for deliberate indifference, as prisoners do not have a constitutional right to limitless medical care.” Brown v. Beard, 445 F. App’x 453, 456 (3d Cir. 2011) (citing Reynolds v. Wagner, 128 F.3d 166, 175 (3d Cir. 1997) (concluding that allegation that prison officials and medical personnel refused plaintiff’s request for hernia surgery due to budgetary concerns was insufficient to state a deliberate indifference claim where documents attached to the complaint showed that medical personnel believed that the hernia was reducible without surgery); see also Winslow v. Prison Health Servs., 406 F. App’x 671, 674 (3d Cir. 2011) (determining that allegation that doctor treated plaintiff with a hernia belt rather than surgery based on the cost of surgery was insufficient to state a claim of deliberate indifference because “the naked assertion that Defendants considered cost in treating [plaintiff’s] hernia does not suffice to state a claim for deliberate indifference as prisoners do not have a constitutional right to limitless medical care, free of the cost constraints under which law-abiding citizens receive treatment” (citations omitted)).
3 The DOC Defendants assert that the DOC has 5400 inmates who are infected with Hepatitis C, all of whom would like to be treated immediately with DAADs, and that the treatment of only one individual with DAADs would cost approximately $55,000. (DOC Defs.’ Mem. at 9.) However, the cost of treating an inmate with DAADs is not alleged in the Amended Complaint and the DOC Defendants have not cited to any alternate source that supports this assertion. Consequently, we cannot consider the DOC Defendants’ assertion that the treatment of a single individual with DAADs would cost $55,000.
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The Amended Complaint, however, contains more than the mere assertion that Defendants considered costs in deciding whether patients with Chronic Hepatitis C infections will receive treatment with DAADs or some other appropriate medical treatment. The Amended Complaint alleges that the DOC has developed a policy regarding the treatment of inmates with Chronic Hepatitis C infections, pursuant to which Defendants refuse to provide medically necessary treatment that is mandated by prevailing community medical standards to 98% of inmates with Chronic Hepatitis C infections. (Am. Compl. ¶¶ 1-2, 29-30.) The Amended Complaint further alleges that the DOC has adopted the policy of denying DAADs to more than 98% of inmates with Chronic Hepatitis C infections solely because of costs, and not based on any medical justification. (Id. ¶¶ 1, 33.) The Amended Complaint also alleges that Chronic Hepatitis C infections cause cirrhosis (irreversible scarring of liver tissue), liver cancer, serious chronic liver disease, liver fibrosis (scarring of liver tissue), and other conditions. (Id. ¶ 19.) Moreover, “[f]or persons with chronic Hepatitis C, each day without treatment increases the likelihood of these conditions” and that by failing to provide medically necessary treatment with DAADs, the Defendants have increased the risks that Plaintiffs and other inmates with Chronic Hepatitis C will suffer irreparable harm stemming from their infections. (Id. ¶¶ 19, 22.) Medical treatment with DAADs cures 90-95% of patients treated and has relatively short treatment periods of 8-12 weeks. (Id. ¶ 26.) Furthermore, while the plaintiffs in Brown and Winslow could be treated with less expensive medical treatments than the surgery they sought4; the Amended Complaint alleges that DAADs are the only treatments that are presently recommended for Chronic Hepatitis C infections. (Id. ¶ 27.)
4 See Brown, 445 F App’x at 456; Winslow, 406 F. App’x at 674. 14

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We conclude, accordingly, that the Amended Complaint sufficiently alleges that the DOC’s use of its Hepatitis C Protocol to ration medical treatment with DAADs based solely on cost, even though there is no other recommended medical treatment for Chronic Hepatitis C, disregards an excessive risk to the health of the infected inmates and thus constitutes deliberate indifference to a serious medical need. As the United States Court of Appeals for the Third Circuit has explained, “while ‘administrative convenience and cost may be, in appropriate circumstances, permissible factors for correctional systems to consider in making treatment decisions, the Constitution is violated when they are considered to the exclusion of reasonable medical judgment about inmate health.’” Allah v. Thomas, 679 F App’x 216, 220 (3d Cir. 2017) (quoting Roe v. Elyea, 631 F.3d 843, 863 (7th Cir. 2011)) (concluding that complaint alleging that DOC denied plaintiff treatment with DAADs for his Hepatitis C infection based solely on cost, causing him to suffer medical complications, “plausibly alleged an Eighth Amendment violation”). Consequently, we deny the DOC Defendants’ Motion to Dismiss Count I of the Amended Complaint as to this argument.
2. Disagreement regarding treatment The individual DOC Defendants also argue that the Amended Complaint does not allege a plausible claim of deliberate indifference because it merely asserts that Plaintiffs disagree with the type of treatment that the DOC is providing for their Chronic Hepatitis C. The DOC Defendants maintain that, although the Amended Complaint alleges that they have failed to adhere to community standards for treatment, they are not obligated to provide inmates with the same community standard of medical care that is provided to non-incarcerated citizens. They further assert that the law does not require them to provide inmates with their preferred medication.
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The individual DOC Defendants rely on Maggert v. Hanks, 131 F.3d 670 (7th Cir. 1997), in which the United States Court of Appeals for the Seventh Circuit stated that “[a] prison is not required by the Eighth Amendment to give a prisoner medical care that is as good as he would receive if he were a free person, let alone an affluent free person. He is entitled only to minimum care.” Id. at 671-72 (citations omitted). See also Goff v. Bechtold, 632 F. Supp. 697, 698 (S.D.W. Va. 1986) (stating that the medical care provided to inmates “need not be the best possible care; it only has to be ‘reasonable’ care” (citations omitted)); Bruton v. Gillis, Civ. A. No. 04-0083, 2008 WL 4453367, at *12 (M.D. Pa. Sept. 30, 2008) (stating that “the Eighth Amendment does not require that a prisoner receive every medical treatment that he requests or that is available elsewhere”). The DOC Defendants further rely on Rozelle v. Rossi, 307 F. App’x 640 (3d Cir. 2008), in which the Third Circuit rejected a prisoner’s Eighth Amendment deliberate indifference claim based on a doctor’s failure to prescribe Accutane for the prisoner’s acne for safety reasons, and the alternative treatments prescribed by the doctor were successful. Id. at 642-43. The individual DOC Defendants also rely on many cases from this Circuit and others, in which courts rejected Eighth Amendment deliberate indifference claims brought by prisoners who challenged a prison’s failure to treat their Hepatitis C infections with the prisoner’s preferred drug. See Lasko v. Watts, 373 F. App’x 196, 203 (3d Cir. 2010) (affirming dismissal of prisoner’s deliberate indifference claim where the prisoner’s treatment with ribavirin and interferon was delayed until he had undergone medically recommended “physical and psychological examinations, extensive laboratory testing, and several counseling sessions”); Hodge v. United States Dep’t of Justice, 372 F. App’x 264, 267-68 (3d Cir. 2010) (affirming order granting summary judgment to defendants on prisoner’s Eighth Amendment deliberate indifference claim where the doctor did not prescribe all of the medications sought by the
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prisoner, who had Hepatitis C, but the prisoner was treated with interferon, monitored, seen at the clinic for complications, and taken to a liver specialist); Neeley v. Carrillo, Civ. A. No. 140542, 2015 WL 7251544, at *3 (E.D. Pa. Nov. 17, 2015) (granting summary judgment in favor of defendants on Eighth Amendment deliberate indifference claim where plaintiff claimed that he had received no treatment for his Hepatitis C, but defendants supplied medical records to show that he had seen doctors, had tests, and received treatment); Watford v. New Jersey State Prison, Civ. A. No. 16-7878, 2016 WL 6841079, at *3 (D.N.J. Nov. 21, 2016) (dismissing prisoner’s deliberate indifference claim based on prison’s failure to treat him with DAADs because the complaint alleged that the prisoner “was provided treatment by both prison doctors and a specialist doctor, and that he received extensive testing ‘with the promise’ of eventual treatment with the medication he wishe[d] to receive” and “he was told that the doctors believed more testing was necessary before proceeding with treatment with Harvoni”); Murray v. Pa. Dep’t of Corrs., Civ. A. No. 15-48, 2016 WL 7744449, at *8, *10 (W.D. Pa. Nov. 16, 2016), approved and adopted by 2017 WL 151636 (W.D. Pa. Jan. 13, 2017) (recommending that defendants’ motion for summary judgment be granted where the inmate claimed deliberate indifference to his serious medical need for treatment of his Hepatitis C infection because defendants failed to treat him with Harvoni, but did not allege any specific actions taken by any individual defendant and the plaintiff’s medical records showed that he had been “frequently seen, examined, and treated for his HCV condition by . . . members of SCI-Albion’s medical staff . . .”).
However, none of the authority on which the individual DOC Defendants rely considered the DOC’s current Hepatitis C protocol, which was adopted by the DOC after most of the cases on which the individual DOC Defendants rely were decided. In two cases decided since the
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DOC adopted the Hepatitis C Protocol, prisoners who brought claims similar to those raised in the instant case were found to have stated claims for deliberate indifference to their serious medical needs. In Allah v. Thomas, the plaintiff alleged that he had requested treatment with Harvoni for his Hepatitis C infection, but was informed “that he could not be given the treatment [be]cause it is expensive.” Allah, 679 F. App’x at 220 (alteration in original) (quotation omitted). The plaintiff “argued that this constituted a deliberate indifference to [his] serious medical needs because he was in danger of developing fibrosis and cirrhosis, his liver [was] deteriorating and [he was] having pain in [his] liver area, and he was starting to get and feel tired all the time and [ ] getting yellowing of the skin.” Id. (alterations in original) (quotations omitted). The Third Circuit concluded that these allegations were sufficient to allege a deliberate indifference claim, given that “Allah alleged that he did not receive any treatment for his Hepatitis C condition, that he was not placed on a newly developed Hepatitis C treatment regimen solely because it was cost-prohibitive, and that he was suffering medical complications as a result.” Id. (citing Roe, 631 F.3d at 863).
In Abu-Jamal v. Wetzel, Civ. A. No. 16-2000, 2017 WL 34700 (M.D. Pa. Jan. 3, 2017), the plaintiff claimed that defendants were deliberately indifferent to his serious medical needs because they refused to treat his chronic Hepatitis C infection with DAADs. Id. at *14. He filed a motion for a preliminary injunction seeking an order requiring the defendants (including Wetzel and Noel) to treat him with DAADs. Id. at *1. The district court had previously held three days of evidentiary hearings in connection with an earlier motion, in which it heard evidence regarding the treatment of Hepatitis C with DAADs, the standard of care for Hepatitis C, and the DOC’s Hepatitis C Protocol. Id. at *1-4. The district court reached the following conclusions of law regarding the DOC’s Hepatitis C Protocol:
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5. The Hepatitis C Protocol, in both how it is written and how it is implemented, bars those without vast fibrosis or cirrhosis from being approved for treatment with [DAAD] medications. As such, the Hepatitis C Protocol presents a conscious disregard of a known risk that inmates with fibrosis, like Plaintiff, will suffer from hepatitis C related complications, continued liver scarring and damage progressing into cirrhosis, and from cirrhosis related complications such as ascites, portal hypertension, hepatic encephalopathy, and esophageal varices.
6. The Hepatitis C Protocol deliberately delays treatment for hepatitis C through the administration of [DAAD] drugs such as Harvoni, Sovaldi, and Viekira Pak despite the knowledge of Defendants that sit on the Hepatitis C Treatment Committee: (1) that the aforesaid [DAAD] medications will effect a cure of Hepatitis C in 90 to 95 percent of the cases of that disease; and (2) that the substantial delay in treatment that is inherent in the current protocol is likely to reduce the efficacy of these medications and thereby prolong the suffering of those who have been diagnosed with chronic hepatitis C and allow the progression of the disease to accelerate so that it presents a greater threat of cirrhosis, hepatocellular carcinoma, and death of the inmate with such disease.
7. Plaintiff was denied the treatment with DAA medications pursuant to DOC policy, not because of any medical exclusions.
8. The named Defendants who sit on the Hepatitis C Treatment Committee deliberately denied administering DAA drugs to Plaintiff despite knowing that administering such drugs was the standard of care. In choosing a course of monitoring over treatment, they consciously disregarded the known risks of Plaintiff's serious medical needs, namely continued liver scarring, disease progression, and other hepatitis C complications.
Id. at *11. The district court concluded that the plaintiff had “established a reasonable likelihood
of success of showing that Defendants were deliberately indifferent to his serious medical need”
and granted the plaintiff’s motion for a preliminary injunction. Id. at *20.
Like the complaints filed in Allah and Abu-Jamal, the Amended Complaint in this action
specifically alleges that Plaintiffs have Chronic Hepatitis C infections, that they all currently
suffer from, or are at risk of suffering from, serious medical conditions as a result of these
infections, and that the DOC has delayed or denied their requests for treatment with DAADs.
(See Am. Compl. ¶¶ 43, 47, 53-54, 56-57, 60, 64-66, 67, 70, 73-79.) The Amended Complaint
also alleges that the DOC Defendants who participated in the DOC’s Hepatitis C Treatment
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Committee developed the DOC’s Hepatitis C Protocol, which was issued in November 2016. (Id. ¶¶ 10-11, 29.) The Hepatitis C Protocol rations treatment with DAADs to prisoners with Chronic Hepatitis C based on the prisoner’s fibrosis level. (Id. ¶¶ 29-31.) The Hepatitis C Protocol prioritizes treatment with DAADs to inmates who already have cirrhosis or liver cancer, are candidates for liver transplants, or have other grave diseases. (Hepatitis C Protocol at 20-7.) The next highest priority for treatment is patients who have advanced fibrosis, Hepatitis B or HIV coinfections, other liver diseases and chronic kidney disease. (Id. at 20-89.) Patients with stage 2 fibrosis are prioritized next, and the lowest priority for treatment is patients with stage 0 or 1 fibrosis. (Id.) However, the Amended Complaint alleges that even individuals with stage 0 to 1 fibrosis should be treated with DAADs because, of this group, “over 70%, if not treated with DAAD[s], will progress to serious fibrosis and, of that group, 30% will develop cirrhosis of the liver.” (Am. Compl. ¶ 31.) Moreover, “[a]ll persons with Chronic Hepatitis C risk liver cancer, liver failure, diabetes, heart failure, kidney disease, and serious physical and mental pain and suffering.” (Id.)
We conclude that the Amended Complaint alleges that the DOC Defendants developed a Hepatitis C Protocol that denies or delays treatment with DAADs to the vast majority of prisoners with Chronic Hepatitis C infections, even though treatment with DAADs is the current standard of care for individuals with Chronic Hepatitis C infections such as the Plaintiffs. The Amended Complaint further alleges that Plaintiffs have experienced a worsening of their serious medical conditions as a result of the denial or delay of their requests for treatment with DAADs. Moreover, the Amended Complaint also alleges that the individual DOC Defendants have denied or delayed treatment of Plaintiffs with DAADs solely because of the cost of those drugs, and not for any medical reasons. We further conclude, accordingly, that the Amended Complaint alleges
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more than a disagreement about Plaintiffs’ medical treatment, or dissatisfaction with the DOC Defendants’ denial of Plaintiffs’ requests for treatment in favor of a different treatment with a possibility of success. Rather, the Amended Complaint alleges that Plaintiffs have serious medical needs for treatment for their Chronic Hepatitis C and that the DOC Defendants intentionally denied and/or delayed Plaintiffs’ access to any medical care for their serious medical needs beginning in 2013. We further conclude, accordingly, that the Amended Complaint alleges facts that are sufficient to state a plausible claim for violation of Plaintiffs’ rights under the Eighth Amendment pursuant to §1983 due to the DOC Defendants’ deliberate indifference to their serious medical needs. See Rhines, 388 F. App’x at 227 (quotation omitted); Allah, 679 F. App’x at 220; Abu-Jamal, 2017 WL 34700, at *11, 20. Accordingly, we deny the DOC Defendants’ Motion to Dismiss Count I of the Amended Complaint as to this argument.
3. Qualified immunity The individual DOC Defendants also argue that they are entitled to qualified immunity with respect to Chimenti’s claim for damages in Count I. “‘Qualified immunity shields federal and state officials from money damages unless a plaintiff pleads facts showing (1) that the official violated a statutory or constitutional right, and (2) that the right was “clearly established” at the time of the challenged conduct.’” Mirabella v. Villard, 853 F.3d 641, 648 (3d Cir. 2017) (quoting Ashcroft v. al-Kidd, 563 U.S. 731, 735 (2011)). As the Supreme Court explained in City and County of San Francisco v. Sheehan, -- U.S. --, 135 S. Ct. 1765 (2015), a public official “‘cannot be said to have violated a clearly established right unless the right’s contours were sufficiently definite that any reasonable official in [his] shoes would have understood that he was violating it,’ meaning that ‘existing precedent . . . placed the statutory or constitutional question
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beyond debate.’” Id. at 1774 (alterations in original) (quoting Plumhoff v. Rickard, 134 S. Ct. 2012, 2023 (2014); and al–Kidd, 563 U.S. at 741). “This exacting standard ‘gives government officials breathing room to make reasonable but mistaken judgments’ by ‘protect[ing] all but the plainly incompetent or those who knowingly violate the law.’” Id. (alteration in original) (quoting al-Kidd, 563 U.S. at 743). Consequently, our analysis of the DOC Defendants’ qualified immunity argument requires a two-step analysis: (1) we decide whether the facts alleged in the Amended Complaint “‘make out a violation of a constitutional right’” and (2) we decide whether that right “‘was clearly established at the time of [the] defendant’s alleged misconduct.’” Montanez v. Thompson, 603 F.3d 243, 250 (3d Cir. 2010) (quoting Pearson v. Callahan, 555 U.S. 223, 232 (2009)). These two steps do not have to be considered in this order. Id. (quoting Pearson, 555 U.S. at 236).
The individual DOC Defendants argue that, based on the allegations of the Amended Complaint, they could not have known that they were violating clearly established law. They rely on Maskelunas v. Wexford Health Source, Inc., Civ. A. No. 14-369, 2015 WL 6686709 (W.D. Pa. Oct. 8, 2015), approved and adopted by 2015 WL 6686719 (W.D. Pa. Oct. 29, 2015), where the district court granted Dr. Paul Noel’s motion for summary judgement with respect to the plaintiff’s § 1983 claim for damages arising from the DOC’s failure to treat his Hepatitis C infection. See id., 2015 WL 6686719, at *1; approving and adopting 2015 WL 6686709, at *1. The magistrate judge recommended that Noel was protected by qualified immunity because Noel’s decision to put a hold on the plaintiff’s treatment for his Hepatitis C infection was the “result of a statewide directive from the [DOC],” which directive arose from “the rapid change in treatment methods for hepatitis C, including the introduction of Sovaldi as a treatment.” Id., 2015 WL 6686709, at *3. The magistrate judge explained that “when the treatment protocols for
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a serious medical condition . . . are in flux, it is impossible for a medical care provider to know what the ‘contours,’ to use the term from Sheehan, of an inmate’s rights are.” Id.
As we discussed above, the Amended Complaint alleges that the FDA approved the use of DAADs to treat Chronic Hepatitis C infections in 2013 and that the individual DOC Defendants denied Chimenti’s requests to be treated with DAADs from late 2013 until October 2016. (Am. Compl. ¶¶ 28, 47-49, 52-54.) While the individual DOC Defendants were denying Chimenti’s requests for treatment with DAADs, his medical condition worsened, until, in the fall of 2015, a mass was discovered in his liver. (Id. ¶ 51.) The individual Defendants then required Chimenti to undergo a medically unnecessary and dangerous liver biopsy before they would consider providing him with any further treatment for his Chronic Hepatitis C infection or referring him to a hepatologist. (Id.) Even after the DOC’s medical staff, including Dr. Frommer, agreed in March 2016 that Chimenti should receive treatment with DAADs and be referred to a transplant hepatologist, the DOC refused to provide Chimenti with this recommended medical treatment. (Id. ¶ 52.) The Amended Complaint further alleges that, while the individual DOC Defendants delayed and denied Chimenti treatment with DAADs, Chimenti suffered from the symptoms of Chronic Hepatitis C, which include cirrhosis, a failing liver, hypertension, jaundice, and confusion. (Id. ¶ 53.) The DOC did not allow Chimenti, who has stage 4 cirrhosis (the most advanced stage), to be referred to a hepatologist for an evaluation until July 2016 and did not provide him with DAAD treatment until October 2016, causing Chimenti to continue to suffer from the symptoms Chronic Hepatitis C infection. (Id. ¶¶ 53-54, 56-57.)
We concluded above that the Amended Complaint alleges a violation of the Plaintiffs’ Eighth Amendment rights. Consequently, we need only determine whether the Amended
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Complaint sufficiently alleges that this right “was clearly established at the time of [the] defendant[s’] alleged misconduct.” Montanez, 603 F.3d at 250. While the Amended Complaint does not allege the date on which use of DAADs to treat Chronic Hepatitis C became the standard of care in the community for the treatment of Chronic Hepatitis C infections, it does allege that the FDA approved the use of these drugs for treatment of Chronic Hepatitis C in 2013, that the DOC refused to allow Chimenti to be treated with these drugs after doctors employed by the DOC recommended that he receive that treatment, and that the DOC required that Chimenti undergo a dangerous and unnecessary medical procedure prior to receiving treatment with DAADs. We conclude that the allegations of the Amended Complaint do not describe a situation in which the “treatment protocols” for Chronic Hepatitis C were “in flux” for the entire period in which the DOC denied Chimenti’s request for treatment with DAADs and required him to undergo an unnecessary and dangerous medical procedure. See Maskelunas, 2015 WL 6686709, at *3. We further conclude, accordingly, that the Amended Complaint does not allege a situation in which it was impossible for the DOC Defendants to know the “contours” of Chimenti’s Eighth Amendment rights. See id.; Sheehan, 135 S. Ct. at 1774 (quotation omitted). Consequently, we will not dismiss Chimenti’s claim for damages against the individual DOC Defendants pursuant to § 1983 at this stage of the litigation based on qualified immunity, and we deny the DOC Defendants’ Motion to Dismiss as to this argument.
B. The Medical Defendants 1. Correct Care Solutions and Wexford
The Medical Defendants move to dismiss Count I as against Correct Care Solutions and Wexford because the Amended Complaint does not allege that either of these Defendants was involved in developing the DOC’s Hepatitis C Policy. It is well settled that a municipal entity
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cannot be sued under § 1983 for the constitutional torts of its employees. See Monell v. Dep’t of Soc. Servs., 436 U.S. 658, 691 (1978). This rule has been extended to private corporations operating under a contract with the state. See Natale v. Camden Cnty. Corr. Facility, 318 F.3d 575, 583-84 (3d Cir. 2003). Indeed, the Third Circuit has made it clear that a private company that provides medical services to inmates at state facilities “‘cannot be held responsible for the acts of its employees under a theory of respondeat superior or vicarious liability.’” Sims v. Wexford Health Sources, 635 F. App’x 16, 20 (3d Cir. 2015) (quoting Natale, 318 F.3d at 583). Therefore, in order to state a § 1983 claim against Correct Care Solutions and Wexford, the Amended Complaint must allege “facts to state a claim that [these Defendants] had a policy, custom, or practice, and that the policy, custom, or practice caused the constitutional violation at issue.” Id. (citing Natale, 318 F.3d at 583-84). See also Stankowski v. Farley, 251 F. App’x 743, 748 (3d Cir. 2007) (stating that a private corporation providing medical care inside a prison may not be held liable for the “constitutional violations committed by its employees, unless [it] has adopted a policy, practice or custom that caused the constitutional violations alleged.” (citing Monell, 436 U.S. at 690; and Woodward v. Corr. Med. Servs., 368 F.3d 917, 927 (7th Cir. 2004)); Ozoroski v. Maue, 460 F. App’x 94, 97-98 (3d Cir. 2011) (“To establish Eighth Amendment liability against a private employer . . . the prisoner must ‘provide evidence that there was a relevant [corporate] policy or custom . . . that . . . caused the constitutional violation [he] allege[s].’” (second through sixth alterations in original) (quoting Natale 318 F.3d at 584)).
The Amended Complaint alleges that Correct Care Solutions “is the current health care provider for all DOC facilities” and that Wexford “was the previous health care provider for all DOC facilities.” (Am. Compl. ¶¶ 12, 16.) The Amended Complaint does not allege that either Correct Care Solutions or Wexford established a corporate policy, or had a corporate practice or
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Case 2:15-cv-03333-JP Document 90 Filed 08/08/17 Page 26 of 30
custom with respect to the use of DAADs to treat inmates with Chronic Hepatitis C. Nor does it allege that any policy, custom, or practice of Correct Care Solutions or Wexford caused the violations of Plaintiffs’ Eighth Amendment rights. We thus conclude that the Amended Complaint does not allege sufficient facts to state a plausible § 1983 claim against either Correct Care Solutions or Wexford for deliberate indifference to Plaintiffs’ serious medical needs in violation of the Eighth Amendment. See Sims, 635 F. App’x at 20 (citing Natale, 318 F.3d at 583-84); Ozoroski, 460 F. App’x at 97-98 (quotation omitted)). We thus grant the Medical Defendants’ Motion to Dismiss Count I of the Amended Complaint as against Correct Care Solutions and Wexford.
2. The individual medical defendants The Medical Defendants argue that Count I should be dismissed as to Dr. Cowan because the Amended Complaint does not allege that he had any personal involvement in creating or implementing the Hepatitis C Protocol. “‘A[n individual government] defendant in a civil rights action must have personal involvement in the alleged wrongdoing; liability cannot be predicated solely on the operation of respondeat superior. Personal involvement can be shown through allegations of personal direction or of actual knowledge and acquiescence.’” Evancho v. Fisher, 423 F.3d 347, 353 (3d Cir. 2005) (alteration in original) (quoting Rode v. Dellarciprete, 845 F.2d 1195, 1207 (3d Cir. 1988)); see also Argueta v. U.S. Immigration & Customs Enf’t, 643 F.3d 60, 72 (3d Cir. 2011) (quoting Rode, 845 F.2d at 1207; and citing Santiago v. Warminster Twp., 629 F.3d 121, 129 (3d Cir. 2010)). Thus, a conclusory allegation that defendants were “directly involved” in the violations of the plaintiff’s rights is not sufficient to allege personal involvement. Bush v. Dep’t of Human Svcs., 614 F. App’x 616, 620 (3d Cir. 2015). See also Wright v. Warden, Forest SCI, 582 F. App’x 136, 137 (3d Cir. 2014) (dismissing § 1983 claim
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against prison officials where the allegations that those officials “had a ‘statutory duty to enforce policies’ and govern the ‘conduct of their subordinates’ . . . fail[ed] to suggest that the Defendants were personally involved in creating or maintaining the dangerous condition” that led to plaintiff’s injuries (citation omittied)); Gorrell v. Yost, 509 F. App’x 114, 118 (3d Cir. 2013) (determining that allegation that mailroom officers were “responsible for the daily operations of the mail room” was “insufficient to establish personal liability” with respect to plaintiff’s claim that prison mailroom staff “interfered with his legal mail by either deliberately withholding it or opening it and failing to forward it to him”).
The Amended Complaint alleges that Dr. Cowan, the statewide Medical Director for Correct Care Solutions, serves on the DOC Hepatitis C Treatment Committee. (Am. Compl. ¶ 13.) The Amended Complaint further alleges that the Hepatitis C Treatment Committee makes the final medical determinations for inmates with Hepatitis C. (Id. ¶ 10.) However, the Amended Complaint does not allege that Dr. Cowan was personally involved in the development of the Hepatitis C Protocol or decision making with respect to the medical treatment of any of the three Plaintiffs. We conclude, accordingly, that the Amended Complaint does not allege sufficient facts to state a plausible § 1983 claim against Dr. Cowan for deliberate indifference to Plaintiffs’ serious medical needs in violation of the Eighth Amendment. We thus grant the Medical Defendants’ Motion to Dismiss Count I of the Amended Complaint as against Dr. Cowan.
The Medical Defendants also argue that Count I should be dismissed as against Dr. Frommer and Dr. Kephart because the allegations of the Amended Complaint assert only that Chimenti is dissatisfied with the medical treatment he received, which is insufficient to support a claim for a violation of the Eighth Amendment. The Medical Defendants argue that, because
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Chimenti received medical care for his Chronic Hepatitis C infection, his claims amount only to a disagreement about his care, and the Amended Complaint thus cannot allege a plausible Eighth Amendment deliberate indifference claim.
The Amended Complaint alleges that Chimenti began to request treatment with DAADs in late 2013 and that those requests were denied, even though the standard of care at that time was treatment with Sovaldi and ribavirin. (Am. Compl. ¶ 47.) In November 2014, Chimenti was notified that the DOC had not approved the use of Harvoni. (Id. ¶ 48.) In late 2014 and early 2015, “emails were exchanged between Dr. Noel, Dr. Dean Rieger . . . , and Dr. Kephart . . . discussing Mr. Chimenti’s medical treatment, and deciding that Mr. Chimenti should merely be monitored and that there was no urgency in providing the latest DAAD medication treatment.” (Id. ¶ 49.) Dr. Kephart (as the former Medical Director of SCI Smithfield) and Dr. Frommer (as the current Medical Director of SCI Smithfield) received, reviewed, and approved all requests for referrals to outside providers and outside medical treatment for Chimenti, and received and reviewed reports from the outside medical providers that related to Chimenti’s Chronic Hepatitis C infection and related conditions. (Id. ¶ 50.) In the fall of 2015, a mass was discovered in Chimenti’s liver and Dr. Frommer insisted that Chimenti undergo a liver biopsy before providing any further treatment or referring Chimenti to a hepatologist, even though a biopsy is not recommended as part of the standard of care. (Id. ¶ 51.) In March 2016, Chimenti met with medical staff, including Dr. Frommer, regarding his Hepatitis C and related medical conditions, and the medical personnel agreed to treatment with DAADs and referral to a transplant hepatologist. (Id. ¶ 52.) This recommendation was denied by DOC’s Central Office. (Id.) During the period from late 2013, until March 2016, during which Dr. Frommer and Dr. Kephart monitored Chimenti’s condition but refused to recommend him for medical treatment for his
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Chronic Hepatitis C, Chimenti developed a mass in his liver and suffered from other symptoms of Chronic Hepatitis C. (Id. ¶ 53.) We conclude that the Amended Complaint alleges more than mere disagreement and dissatisfaction with Chimenti’s medical care; it alleges that Chimenti suffers from a serious medical condition, that Dr. Kephart and Dr. Frommer deliberately delayed treatment for that medical condition, and that Chimenti’s condition worsened during the period of delay. The Amended Complaint further alleges that Dr. Frommer required Chimenti to undergo a dangerous and unnecessary medical procedure. We further conclude, accordingly, that Count I of the Amended Complaint states a plausible § 1983 claim for violation of Chimenti’s Eighth Amendment rights against Dr. Kephart and Dr. Frommer. See Estelle, 429 U.S. at 104; Rhines, 388 F. App’x at 227 (quoting Estelle, 429 U.S. at 104-05). IV. CONCLUSION
For the reasons stated above, the DOC Defendants’ Motion to Dismiss all claims raised in the Amended Complaint against the DOC and Rich Wenhold is granted by agreement of the parties and those Defendants are dismissed as defendants in this proceeding. The DOC Defendants’ Motion to Dismiss is denied as to Count I as against the other DOC Defendants. The Medical Defendants’ Motion to Dismiss as to Count I is granted as to the claims asserted against Correct Care Solutions, Wexford, and Dr. Cowan. By agreement of the parties, the Medical Defendants’ Motion to Dismiss as to Count I is also granted as to the claims for injunctive relief against Dr. Kephart and Dr. Frommer (as of the time Dr. Frommer leaves his position as Medical Director of SCI Smithfield). The Medical Defendants’ Motion to Dismiss as to Count I is denied as to the claims for monetary damages asserted in Count I against Dr. Kephart and Dr. Frommer. Count II is dismissed by agreement of the parties to the extent that it seeks an award of monetary damages and is also dismissed to the extent that it seeks injunctive
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Case 2:15-cv-03333-JP Document 90 Filed 08/08/17 Page 30 of 30 relief as against all Defendants except for Secretary Wetzel. Count III is dismissed as against Secretary Wetzel by agreement of the parties. Accordingly, Plaintiffs may pursue the § 1983 claim raised in Count I for both injunctive relief and damages against Secretary Wetzel and Dr. Noel, and for monetary damages only against Dr. Kephart and Dr. Frommer. Plaintiffs also may pursue Count II for injunctive relief against Secretary Wetzel; Count III as against Dr. Paul Noel, Correct Care Solutions, Dr. Cowan, Dr. Kephart, Dr. Frommer, and Wexford; and Count IV as against Correct Care Solutions and Wexford. An appropriate order follows.
BY THE COURT: /s/ John R. Padova ____________________________ John R. Padova, J.
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 Case 2:15-cv-03333-JP Document 107 Filed 05/24/18 Page 1 of 22

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

SALVATORE CHIMENTI, ET AL.

:

:

v.

:

:

JOHN WETZEL, ET AL.

:

CIVIL ACTION NO. 15-3333

MEMORANDUM

Padova, J.

May 24, 2018

Plaintiffs Salvatore Chimenti, Daniel Leyva, and David Maldonado have brought this

lawsuit against John Wetzel, the Secretary of the Pennsylvania Department of Corrections (the

“DOC”), and Paul Noel, the Chief Medical Director of the DOC (collectively the “DOC

Defendants”), as well as two companies that have contracted to provide medical services for the

DOC and officials and employees of those companies (collectively the “Medical Defendants”),

asserting claims regarding the medical care provided to DOC inmates who have been diagnosed

with Hepatitis C viral infections (“HCV”). Specifically, Plaintiffs contend that the DOC

Defendants have violated their rights under the Eighth Amendment and the Pennsylvania

Constitution by adopting a policy for the treatment of inmates with chronic HCV that fails to

provide them with appropriate medical care.1 Plaintiffs seek injunctive relief requiring the DOC

Defendants to formulate and implement a Hepatitis C treatment policy that (1) meets the

community standards of care for patients with chronic HCV; (2) ensures that inmates with

chronic HCV are treated with medically necessary and appropriate direct-acting antiviral drugs

(“DAAs”); and (3) provides ongoing monitoring and medical care in accordance with the

standard of care for such patients’ liver fibrosis and cirrhosis.

1 Plaintiff Chimenti has also brought personal claims for medical malpractice against all Defendants.

Case 2:15-cv-03333-JP Document 107 Filed 05/24/18 Page 2 of 22
Plaintiffs seek to represent a class of similarly situated inmates of the DOC who have at least twelve weeks remaining to serve on their sentences. Before the Court is Plaintiffs’ Renewed Motion for Class Certification, which is opposed by the DOC Defendants.2 For the following reasons, the Motion is granted. I. FACTUAL BACKGROUND
Plaintiffs Chimenti, Leyva, and Maldonado all suffer from chronic HCV and were, at the time of the filing of this action, incarcerated in correctional institutions that are part of the DOC. (See Compl. (Docket No. 1) ¶¶ 1-2; DOC Defs.’ Ans. to Compl. (Docket No. 30) ¶¶ 1-2.) Beginning in 2011, the United States Food and Drug Administration (“FDA”) approved DAAs for the treatment of Hepatitis C. (Trooskin Rpt., Pls.’ Resp. to Mot. for Summ. J., Ex. A at 2.) These drugs, which include Harvoni, are capable of achieving a “sustained virologic response,” which means “the elimination of the virus[,] for more than 90% of patients.” (Id. at 2-3.) Prior to the development of DAAs, the standard of care “was a three-drug treatment containing boceprevir or telaprevir, interferon and ribavirin” that “provided, at best, a 70% cure rate, and was accompanied by significant adverse side effects such as anemia, insomnia, anxiety, depression, nausea, bone pain, muscle [pain], liver failure, joint pain, memory loss, and death.” (Id. at 2.) Plaintiffs’ expert, Dr. Stacey Trooskin, has opined that the use of DAAs is now “the standard of medical care for the treatment of all HCV individuals.” (Id. at 3.)
When Chimenti, Leyva, and Maldonado first asked to be treated with DAAs, their applications were rejected by the DOC. Chimenti began requesting treatment with DAAs in late 2013, but Defendants denied his requests. (Pls.’ Counterstatement of Add’l Facts (“PSAF”) ¶¶
2 The Medical Defendants do not oppose Plaintiffs’ Renewed Motion for Class Certification.
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225-30; DOC Defs.’ Resp. to Pls.’ Counterstatement of Add’l Facts (“DRPCAF”) ¶¶ 225-30.) Chimenti filed grievances asking for treatment with DAAs in early 2014, but his grievances were denied because the DOC did not have a Hepatitis C protocol and had put all Hepatitis C treatment on hold. (PSAF ¶¶ 226-28; DRPCAF ¶¶ 226-28.) Chimenti has suffered from Stage 4 Cirrhosis since at least 2000. (Pls.’ Resp. to Mot. for Summ. J., Ex. U at 5.) In October 2015, Chimenti was diagnosed with liver cancer. (PSAF ¶ 232; DRPCAF ¶ 232.) Chimenti was treated with DAAs beginning in October 2016. (PSAF ¶ 236; DRPCAF ¶ 236.)
Leyva filed a grievance with the DOC on January 13, 2015, asking to be treated with the new Hepatitis C drugs. (Pls.’ Resp. to Mot. for Summ. J., Ex. V at 2.) The DOC upheld his grievance, but told him that it was evaluating its treatment options and developing a new treatment protocol and, in the meantime, would only monitor patients with HCV. (Id. at 3.) On March 4, 2015, Leyva sent a letter to the DOC expressing his concern with having to wait for treatment while the DOC developed a new treatment protocol for Hepatitis. (See id. at 4.) The DOC responded that it was continuing to monitor inmates with HCV while it evaluated treatment options. (Id.) On April 7, 2015, Leyva filed a new grievance, asking to be treated with Harvoni. (Id. at 5.) That grievance was denied. (Id. at 7-19.) Leyva still has not received treatment with DAAs. (lst Am. Class Action Compl. (“1st Am. Compl.” ¶ 68; DOC Defs.’ Ans. to lst Am. Compl. ¶ 13.) Maldonado also filed a grievance asking to be treated with the latest DAAs, but his grievance was rejected because the DOC was developing a new treatment protocol. (1st Am. Compl. ¶¶ 73-74; DOC Defs.’ Ans. to 1st Am. Compl. ¶ 16.) The DOC has not treated Maldonado with DAAs. (DOC Defs.’ Ans. to 1st Am. Compl. ¶ 16.)
The DOC issued a new protocol for the treatment of HCV on November 7, 2016. (DOC Defs.’ Statement of Material Facts (“SMF”) ¶ 40; Pls.’ Resp. to SMF ¶ 40.) The Hepatitis C
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Treatment Protocol does not require the DOC to treat all inmates with HCV with DAAs. Instead, the Protocol requires the DOC to treat the sickest inmates first, and it bases its treatment decisions on an inmate’s fibrosis score. (SMF ¶¶ 45, 53; Pls.’ Resp. to SMF ¶¶ 45, 53.) Fewer than 10% of DOC inmates with chronic HCV have been treated with DAAs under the Protocol. (PSAF ¶ 178; DRPCAF ¶ 178.)
Plaintiffs seek to represent the following Class: all persons who are currently incarcerated in a Pennsylvania Department of Corrections (“DOC”) facility with a diagnosed condition of chronic Hepatitis C, and who have at least twelve (12) weeks or more remaining to serve on their sentences, and who have a life expectancy of over one year. (Renewed Mot. for Class Cert. at 2.) As of September 20, 2017, the DOC held 7521 inmates who have been infected with Hepatitis C, 5265 of whom have chronic HCV. (Wenhold Decl., DOC Defs.’ Mot. for Summ. J., Ex. F, ¶¶ 15-16.) The DOC has treated 297 of those inmates who have chronic HCV with DAAs. (Id. ¶ 17.) The First Amended Complaint states four claims for relief. Count I asserts a claim pursuant to 42 U.S.C. § 1983 on behalf of the three named Plaintiffs and the Class for deliberate indifference to the serious medical needs of prisoners infected with HCV in violation of the Eighth Amendment to the United States Constitution. Count II asserts a claim on behalf of the three named Plaintiffs and the Class for violation of Article I, § 13 of the Pennsylvania Constitution. Count III asserts a claim for medical malpractice against all Defendants on behalf of Chimenti. Count IV asserts a claim against Correct Care Solutions and Wexford for medical malpractice on behalf of Chimenti. Plaintiffs seek an injunction on behalf of themselves and the Class ordering the DOC to: (a) formulate and implement a Hepatitis C treatment policy that meets the community standards of care for patients with Hepatitis C, (b) that members of
4

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the Class be treated with medically necessary and the appropriate direct-acting antiviral drugs based on individual medical testing and medical evaluation regarding each individual’s Hepatitis C status, and (c) that members of the [C]lass receive ongoing monitoring and medical care per the standard of care for their individual level of liver fibrosis and cirrhosis, including but not limited to appropriate access to and evaluation by a hepatologist and assessment regarding their need for partial or full liver transplant.
(Id. ¶ 98.) Plaintiffs also seek compensatory and punitive damages for Chimenti, reasonable
attorney’s fees and costs, and such other relief as the Court deems just and equitable. (Id. ¶¶ 99-
102.)
II. LEGAL STANDARD
In order to be certified, a class action “‘must satisfy the four requirements of Rule 23(a)
and the requirements of either Rule 23(b)(1), (2), or (3).’” In re Modafinil Antitrust Litig., 837
F.3d 238, 248 (3d Cir. 2016) (quoting Marcus v. BMW of N.A., LLC, 687 F.3d 583, 590 (3d Cir.
2012)). “The party seeking certification bears the burden of establishing each element of Rule
23 by a preponderance of the evidence.” Marcus, 687 F.3d at 591 (citing In re Hydrogen
Peroxide Antitrust Litig., 552 F.3d 305, 307 (3d Cir. 2009)). Thus, Plaintiffs must establish the
following four elements:
(1) the class must be “so numerous that joinder of all members is impracticable” (numerosity); (2) there must be “questions of law or fact common to the class” (commonality); (3) “the claims or defenses of the representative parties” must be “typical of the claims or defenses of the class” (typicality); and (4) the named plaintiffs must “fairly and adequately protect the interests of the class” (adequacy of representation, or simply adequacy).
In re Cmty. Bank of N. Va., 622 F.3d 275, 291 (3d Cir. 2010) (quoting Fed. R. Civ. P. 23(a)(1)-
(4)). If Plaintiffs are able to satisfy these requirements, “we consider whether the class meets the
requirements of one of three categories of class actions in Rule 23(b).” In re Nat’l Football
League Players Concussion Injury Litig., 821 F.3d 410, 426 (3d Cir.), cert. denied sub nom.
5

Case 2:15-cv-03333-JP Document 107 Filed 05/24/18 Page 6 of 22
Gilchrist v. Nat’l Football League, 137 S. Ct. 591 (2016), and cert. denied sub nom. Armstrong v. Nat’l Football League, 137 S. Ct. 607 (2016). Plaintiffs ask us to certify the Class under Rule 23(b)(2), which applies when “the party opposing the class has acted or refused to act on grounds that apply generally to the class, so that final injunctive relief or corresponding declaratory relief is appropriate respecting the class as a whole.” Fed. R. Civ. P. (23)(b)(2).
The DOC Defendants oppose class certification on three grounds. They first argue that the Class is not sufficiently numerous to be certified. They next argue that the named Plaintiffs do not have claims that are typical of the claims of the absent Class members. They finally argue that, because the named Plaintiffs’ claims are not typical, they would not be adequate representatives of the members of the Class.3 III. DISCUSSION
A. The Rule 23(a) Factors 1. Numerosity
The United States Court of Appeals for the Third Circuit has stated that there is “‘[n]o minimum number of plaintiffs . . . required to maintain a suit as a class action.’” Modafinil, 837 F.3d at 249 (first alteration in original) (quoting Stewart v. Abraham, 275 F.3d 220, 226 (3d Cir. 2001)). However, in general, “‘if the named plaintiff demonstrates that the potential number of plaintiffs exceeds 40, the first prong of Rule 23(a) has been met.’” Id. at 250 (quoting Stewart,
3 The DOC Defendants also contend that we should deny the instant Motion because most of the Class members lack standing as “[f]uture inmates do not have standing to belong in this action where any future injury is not actual or imminent. Current inmates with a fibrosis level of zero lack requisite injury for standing.” (DOC Defs.’ Brief at 4.) The DOC Defendants, however, have not explained this argument or supported it with reference to evidence or legal authority. Accordingly, we do not consider this argument in the context of the instant Motion.
6

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275 F.3d at 226-27, and citing Robidoux v. Celani, 987 F.2d 931, 936 (2d Cir. 1993)). “At the other end of the spectrum, the Supreme Court has stated in dicta that a class of fifteen was ‘too small to meet the numerosity requirement.’” Id. (quoting Gen. Tel. Co. of the Nw, Inc. v. EEOC, 446 U.S. 318, 331 (1980)).
The DOC Defendants argue that the class is not sufficiently numerous to support certification because only seven current DOC inmates had satisfied the Prison Litigation Reform Act’s (“PLRA”) exhaustion requirement with respect to the claims asserted in this action prior to the filing of the Complaint. The PLRA provides that “[n]o action shall be brought with respect to prison conditions under section 1983 of this title, or any other Federal law, by a prisoner confined in any jail, prison, or other correctional facility until such administrative remedies as are available are exhausted.” 42 U.S.C. § 1997e(a). The United States Court of Appeals for the Eleventh Circuit has held that “a class of prisoner-plaintiffs certified under Rule 23(b)(2) satisfies the PLRA’s administrative exhaustion requirement through ‘vicarious exhaustion,’ i.e., when ‘one or more class members ha[s] exhausted his administrative remedies with respect to each claim raised by the class.’” Chandler v. Crosby, 379 F.3d 1278, 1287 (11th Cir. 2004) (alteration in original) (quoting Jones ‘El v. Berge, 172 F. Supp. 2d 1128, 1133 (W.D. Wis. 2001); and citing Hattie v. Hallock, 8 F. Supp. 2d 685, 689 (N.D. Ohio 1998)). The Eleventh Circuit explained that it reached this holding for two reasons. “First, this rule advances the purpose of administrative exhaustion, which, we have stated (albeit in the employment context), ‘is to put the [administrative authority] on notice of all issues in contention and to allow the [authority] an opportunity to investigate those issues.’” Id. (alterations in original) (quoting Griffin v. Carlin, 755 F.2d 1516, 1531 (11th Cir. 1985)). “Second, a different rule, e.g., one requiring all class members to exhaust their administrative remedies, ‘could impose an
7

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intolerable burden upon the inmate complaint review system.’” Id. (quoting Jonas ‘El, 172 F. Supp. 2d at 1131-32). “Moreover, in cases like this one, where the composition of the class is subject to constant change beyond the class members’ control, it could be extraordinarily difficult for all class members to exhaust administrative remedies before filing suit.” Id. (citing Jonas ‘El, 172 F. Supp. 2d at 1131).
The United States Court of Appeals for the Third Circuit has not yet addressed “vicarious exhaustion,” but other courts have permitted it in § 1983 class actions filed by inmates. See Hubbard v. Danberg, Civ. A. No. 07-745-GMS, 2010 WL 883776, at *6 n.9 (D. Del. Mar. 10, 2010) (citing Chandler, 379 F.3d 1278; and Meisberger v. Donahue, 245 F.R.D. 627 (S.D. Ind. 2007) (additional citation omitted)), aff’d, 408 F. App’x 553 (3d Cir. 2010). For example, the United States Court of Appeals for the Fifth Circuit, like the Eleventh Circuit, has determined that the exhaustion of administrative remedies by one class member is sufficient to satisfy the PLRA’s exhaustion requirement for the entire class. See Gates v. Cook, 376 F.3d 323, 330 (5th Cir. 2004) (concluding that one plaintiff’s satisfaction of the Mississippi Department of Corrections’ Administrative Remedy Program was “enough to satisfy the requirement for the class” (citations omitted)). District Courts in other Circuits have also held that “the PLRA’s exhaustion requirement is limited to the class representatives.” Decoteau v. Raemisch, 304 F.R.D. 683, 687 (D. Col. 2014) (citing Chandler, 379 F.3d at 1287; Gates, 376 F.3d at 330; and Jackson v. District of Columbia, 254 F.3d 262, 269 (D.C. Cir. 2001)); see also Butler v. Suffolk Cty., 289 F.R.D. 80, 97 (E.D.N.Y. 2013) (finding that “whether the purported class members have exhausted their administrative remedies is irrelevant to the class certification analysis” where the class representatives have satisfied the PLRA exhaustion requirement); Scott v. Clarke, 64 F. Supp. 3d 813, 832 n.10 (W.D. Va. 2014) (concluding that the efforts of the named
8

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plaintiffs and several other class members, who fully exhausted their prison medical grievances, “easily support[ed] a finding of PLRA exhaustion on behalf of the entire class”).
We agree with the Eleventh Circuit’s reasoning in Chandler and we conclude that, if any of the named Plaintiffs, Chimenti, Leyva, and Maldonado, have satisfied the PLRA’s administrative exhaustion requirement, the exhaustion requirement is satisfied for all of the absent class members through vicarious exhaustion. See Chandler, 379 F.3d at 1287. As we discussed above, Chimenti, Leyva, and Maldonado all filed grievances with respect to the DOC’s refusal to treat them with DAAs. The DOC contends that Leyva did not fully exhaust his administrative remedies in accordance with the PLRA before this suit was filed. However, the DOC Defendants do not suggest that either Chimenti or Maldonado has failed to satisfy the PLRA’s exhaustion requirement. Consequently, we conclude that the PLRA’s exhaustion requirement is satisfied through vicarious exhaustion and that the class is not limited to the seven prisoners with HCV who have personally exhausted their administrative remedies with respect to treatment with DAAs.
The DOC Defendants have submitted evidence that, as of September, 2017, the DOC held 4968 inmates who have chronic HCV and had not been treated with DAAs. (Wenhold Decl. ¶¶ 15-17.) We conclude that a class of 4968 inmates is sufficiently “‘numerous that joinder of all members is impracticable,’” In re Cmty. Bank, 622 F.3d at 291 (quoting Fed. R. Civ. P. 23(a)(1)), and that the proposed class thus satisfies the numerosity requirement, Modafinil, 837 F.3d at 249-50 (quotation and citation omitted).
2. Commonality Commonality requires “‘a plaintiff to show that ‘there are questions of law or fact common to the class.’” Wal-Mart Stores, Inc. v. Dukes, 564 U.S. 338, 349 (2011) (quoting Fed.
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Case 2:15-cv-03333-JP Document 107 Filed 05/24/18 Page 10 of 22
R. Civ. P. 23(a)(2)). Consequently, Plaintiffs’ claims “must depend upon a common contention . . . [and] [t]hat common contention . . . must be of such a nature that it is capable of classwide resolution—which means that determination of its truth or falsity will resolve an issue that is central to the validity of each one of the claims in one stroke.” Id. “Rule 23(a)(2)’s commonality requirement ‘does not require identical claims or facts among class member[s].’” Marcus, 687 F.3d at 597 (alteration in original) (quoting Chiang v. Veneman, 385 F.3d 256, 265 (3d Cir. 2004), abrog. on other grounds by Hydrogen Peroxide, 552 F.3d at 318 n.18). “‘For purposes of Rule 23(a)(2), even a single common question will do.’” Id. (quoting Dukes, 564 U.S. at 359; and citing In re Schering Plough Corp. ERISA Litig., 589 F.3d 585, 597 (3d Cir. 2009)).
Plaintiffs assert that the following two questions of fact are both central to their claims and common to all of the members of the proposed class:
1. Whether the treatment regimens utilizing the DAA drugs are the proper, necessary, and standard course of treatment in the medical community; and
2. Whether denial of treatment regimens utilizing the DAA drugs to the Proposed Class will cause injury to the class members, including unnecessary pain and suffering, chronic illness, and death.
(Pls.’ Mem. at 13.) Plaintiffs also maintain that this case presents a common question of law, i.e., “whether the DOC’s current Hepatitis C Protocol violates the Eighth Amendment to the U.S. Constitution and Article I § 13 of the Pennsylvania Constitution in denying thousands of inmates necessary medical care.” (Id. at 14.) Moreover, the injunctive relief that Plaintiffs seek on behalf of the class involves changing the DOC’s policies with regard to treatment of all inmates with chronic HCV.
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Plaintiffs’ claims for injunctive relief on behalf of the putative class are based on Defendants’ policy regarding the treatment of inmates with chronic HCV. Thus, in connection with their Eighth Amendment and Pennsylvania constitution claims, “all class members share the common question of whether the [DOC] Defendants’ policy or custom of withholding treatment with DAA drugs from individuals who have been or will be diagnosed with chronic HCV constitutes deliberate indifference to a serious medical need.” Postawko v. Missouri Dep’t of Corr., Civ. A. No. 16-4219, 2017 WL 3185155, at *7 (W.D. Mo. July 26, 2017) (finding that element of commonality is satisfied in class action asserting 8th Amendment claim against the Missouri Department of Corrections because “all class members share the common question of whether the Defendants’ policy or custom of withholding treatment with DAA drugs from individuals who have been or will be diagnosed with chronic HCV constitutes deliberate indifference to a serious medical need”) (appeal docketed Sept. 19, 2017). See also Graham v. Parker, Civ. A. No. 16-1954, 2017 WL 1737871, at *1, *4 (M.D. Tenn. May 4, 2017) (finding that element of commonality is met in class action challenging the constitutionality of “the State of Tennessee’s policies and procedures for inmates with Hepatitis C” where the proposed class is made up of all inmates with Hepatitis C infections and Plaintiffs challenge “the official policies and practices applicable to all inmates with Hepatitis C”); Stafford v. Carter, Civ. A. No. 17-0289, 2018 WL 1140388, at *5-6 (S.D. Ind. Mar. 2, 2018) (concluding that the commonality requirement is satisfied in class action challenging the constitutionality of the Indiana Department of Corrections’ treatment of prisoners who suffer from chronic HCV where the Defendants’ policies regarding the treatment of HCV formed the basis of the common questions of fact and law). Moreover,
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Case 2:15-cv-03333-JP Document 107 Filed 05/24/18 Page 12 of 22
the relief Plaintiffs seek on behalf of the putative class is an injunction changing the DOC’s Hepatitis C Protocol in a manner that will affect all DOC inmates with HCV. See Hoffer v. Jones, 323 F.R.D. 694, 697-98 (N.D. Fla. 2017) (concluding that plaintiffs satisfied the commonality requirement in class action challenging the constitutionality of medical care provided by Florida Department of Corrections to inmates with HCV where there were common questions involving the appropriate standard of care for persons with chronic HCV and whether a failure to meet that standard violates the Eighth Amendment, and the relief sought with respect to the class was “limited to changing Defendant’s policies and practices”). We conclude, accordingly, that the commonality requirement is met in this case.
3. Typicality “The concepts of typicality and commonality are closely related and often tend to merge.” Marcus, 687 F.3d at 597 (citing Baby Neal v. Casey, 43 F.3d 48, 56 (3d Cir. 1994)). “Typicality, however, derives its independent legal significance from its ability to ‘screen out class actions in which the legal or factual position of the representatives is markedly different from that of other members of the class even though common issues of law or fact are present.’” Id. at 598 (quoting 7A Charles Alan Wright et al., Federal Practice and Procedure § 1764 (3d ed. 2005)). In order to “determine whether a plaintiff is markedly different from the class as a whole, we consider the attributes of the plaintiff, the class as a whole, and the similarity between the plaintiff and the class.” Id. (citing Schering Plough, 589 F.3d at 597). In making our determination, we consider the following three factors: “(1) the claims of the class representative must be generally the same as those of the class in terms of both (a) the legal theory advanced and (b) the factual circumstances underlying that theory; (2) the class representative must not be
12

Case 2:15-cv-03333-JP Document 107 Filed 05/24/18 Page 13 of 22
subject to a defense that is both inapplicable to many members of the class and likely to become a major focus of the litigation; and (3) the interests and incentives of the representative must be sufficiently aligned with those of the class.” Id. (quoting Schering Plough, 589 F.3d at 599). However, “[i]f a plaintiff’s claim arises from the same event, practice or course of conduct that gives rises to the claims of the class members, factual differences will not render that claim atypical if it is based on the same legal theory as the claims of the class.” Id. (citing Hoxworth v. Blinder, Robinson & Co., 980 F.2d 912, 923 (3d Cir. 1992)). Indeed, the Third Circuit has “set a ‘low threshold’ for typicality.” In re Nat’l Football League, 821 F.3d at 428 (quoting Newton v. Merrill Lynch, Pierce, Fenner & Smith, Inc., 259 F.3d 154, 183 (3d Cir. 2001)). “‘Even relatively pronounced factual differences will generally not preclude a finding of typicality where there is a strong similarity of legal theories or where the claim arises from the same practice or course of conduct.’” Id. (quoting In re Prudential Ins. Co. Am. Sales Practice Litig. Agent Actions, 148 F.3d 283, 311 (3d Cir. 1998)). Plaintiffs contend that the typicality requirement is met in this case because the claims of Chimenti, Leyva, and Maldonado arise from the same policy as the claims of the members of the putative class, namely the DOC’s customs and policies regarding the treatment of HCV. Specifically, they assert that all three of the named Plaintiffs suffer from chronic HCV and are presently, or have been, denied treatment with DAAs pursuant to the DOC’s policies. Plaintiffs rely on Postawko, in which the court found that the typicality requirement was met because the claims of the named plaintiffs and the class they sought to represent all arose from the Missouri Department of Corrections’ policies for treating inmates with chronic HCV, including their policy of denying treatment with DAAs to certain inmates based on the severity of their disease. Postawko, 2017 WL 3185155, at *11. The Postawko court found that the named plaintiffs’
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Case 2:15-cv-03333-JP Document 107 Filed 05/24/18 Page 14 of 22
claims that those policies violated their Eighth Amendment rights were “identical to the claims that could be raised by any member of the class.” Id. The Postawko court further found that “all putative class members share a common injury of having these policies applied to them and as a result, suffering a significant risk of harm” and, therefore, the named plaintiffs were typical “because they, too, are exposed to the same risk. Like the remainder of the class, they are HCVpositive inmates to which the alleged policy has been applied and who have not been treated with DAA drugs.” Id. (citing Alpern v. UtiliCorp. United, Inc., 84 F.3d 1525, 1540 (8th Cir. 1996)); see also Graham, 2017 WL 1737871, at *5 (concluding that “Plaintiffs’ claims are typical of the claims of the class because they are seeking declaratory, injunctive class-wide relief only that may benefit the entire class”).
The DOC Defendants argue, however, that Chimenti, Leyva, and Maldonado are not typical of the class they seek to represent because they are subject to unique defenses. Specifically, the DOC Defendants argue that Chimenti is not a typical plaintiff because he has received treatment with DAAs and has brought individual claims against Defendants for medical malpractice. The DOC Defendants also argue that Leyva is not a typical plaintiff because he is subject to the defense that he failed to exhaust his administrative remedies prior to filing suit. Finally, the DOC Defendants argue that Maldonado is not typical because he is subject to the defense that his claims are moot because he is no longer incarcerated by the DOC.
a. Chimenti Plaintiffs request certification of a class of individuals who seek injunctive relief. As we discussed above, Plaintiffs seek an injunction that will require Defendants to do the following: (a) formulate and implement a Hepatitis C treatment policy that meets the community standards of care for patients with Hepatitis C, (b) that members of the Class be treated with medically necessary and the appropriate direct-acting
14

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antiviral drugs based on individual medical testing and medical evaluation regarding each individual’s Hepatitis C status, and (c) that members of the class receive ongoing monitoring and medical care per the standard of care for their individual level of liver fibrosis and cirrhosis, including but not limited to appropriate access to and evaluation by a hepatologist and assessment regarding their need for partial or full liver transplant. (1st Am. Compl. ¶ 98.) Chimenti has already received treatment with DAAs and, accordingly, no longer personally needs the second of the three items in the requested injunction. (PSAF ¶ 232; DRPCAF ¶ 232.) However, there is no basis on the record before us upon which we could determine that Chimenti has no interest in requiring the DOC Defendants to formulate and implement a policy for the treatment of Hepatitis C that meets community standards of care or that he no longer needs monitoring and medical care for Cirrhosis or liver fibrosis. Furthermore, Chimenti’s claims for monetary damages pursuant to § 1983 and his medical malpractice claims are based on the same basic facts as the claims for injunctive relief brought on behalf of the class pursuant to § 1983 and the Pennsylvania Constitution, i.e., Defendants’ failure to develop a policy to treat all inmates who have chronic HCV in accordance with community standards, which involves the use of DAAs. We conclude that the factual differences between Chimenti and the members of the putative class are not pronounced and that Chimenti satisfies the “low threshold” for typicality in this case, In re Nat’l Football League, 821 F.3d at 428 (quotation omitted), since his claims for monetary damages arise from the same policy and practice as the class’s claim for injunctive relief. We further conclude, accordingly, that Plaintiffs have satisfied the typicality requirement as to Chimenti.
b. Leyva The DOC Defendants contend that Leyva is not typical because he is subject to the defense that he failed to exhaust his administrative remedies in accordance with the PLRA prior
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to filing the instant lawsuit. Specifically, the DOC Defendants argue that Leyva did not exhaust his administrative remedies prior to filing suit because the DOC’s Secretary’s Office of Inmate Grievances and Appeals did not issue a decision at the third level on Leyva’s grievance until September 8, 2015, nearly three months after this action was initiated on June 12, 2015.4 “If exhaustion is incomplete when an inmate files suit, dismissal is mandatory.” Turner v. Sec’y Pa. Dep’t of Corr., 683 F. App’x 180, 182 n.1 (3d Cir. 2017) (citing Porter v. Nussle, 534 U.S. 516, 524 (2002); and Nyhuis v. Reno, 204 F.3d 65, 77 n.12 (3d Cir. 2000)). Moreover, “[a]n inmate cannot cure non-compliance with [the PLRA] by exhausting remedies after filing his complaint.” Id. (citation omitted).
Leyva filed two grievances regarding the DOC’s failure to treat his HCV with DAAs. The first was filed on January 13, 2015 and upheld on January 15, 2015. (See Pls.’ Resp. to Mot. for Summ. J., Ex. V at 2-3.5) However, even though Leyva’s appeal was upheld, he did not receive treatment with DAAs, and he filed a second grievance on April 7, 2015. (See id. at 5.) Leyva’s second grievance was denied on April 17, 2015 and he appealed the denial of that grievance on April 25, 2015. (Id. at 7-8.) He filed his third level appeal on May 13, 2015, which was denied by the Secretary’s Office of Inmate Grievances and Appeals on September 8, 2015.
4 The DOC Defendants briefly refer to this argument in their Brief in Opposition to Renewed Motion to Class Certification, but do not discuss it in detail. The DOC Defendants explain the basis of this argument in their Brief in Support of their Motion for Summary Judgment. Since the Motion for Summary Judgment also forms part of the record before us, we have referred to that document to gain an understanding of the basis of their argument.
5 Plaintiffs’ Reply to the DOC’s Answer to their Motion for Class Certification crossreferences their discussion of this issue in their Response to the Motion for Summary Judgment, so we have considered the argument Plaintiffs make in their Summary Judgment Response and the evidence that they have submitted in connection with that Response.
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(Id. at 10, 19.) We therefore find that Leyva did not exhaust his second grievance regarding treatment of his HCV with DAAs prior to the filing of the instant lawsuit on June 12, 2015.
Consequently, Leyva is subject to the defense that he did not exhaust his administrative remedies prior to bringing suit. This defense, however, is not unique to Leyva, as the DOC Defendants have asserted that it applies to nearly all members of the putative class. Moreover, we have determined that vicarious exhaustion applies in this case. See Chandler, 379 F.3d at 1287. Since there is no question that Chimenti and Maldonado have properly exhausted their administrative remedies pursuant to the PLRA, the defense of failure to exhaust is not “likely to become a major focus of [this] litigation.” Marcus, 687 F.3d at 598 (quotation omitted). Consequently, we conclude that Leyva’s failure to fully exhaust his administrative remedies with respect to his second grievance prior to filing suit does not destroy his typicality in this case. We further conclude, accordingly, that Plaintiffs have satisfied the typicality requirement as to Leyva.
c. Maldonado The DOC Defendants argue that Maldonado is not a typical plaintiff because he has been released from the custody of the DOC and his claim is now moot.6 Maldonado was paroled on May 15, 2017. (DOC Defs.’ Mot. for Summ. J. Ex. H at 2.) Plaintiffs filed their initial Motion for Class Certification on June 12, 2015 and their Renewed Motion for Class Certification on October 2, 2017. (See Docket Nos. 2, 94.) The Supreme Court has held that “an action brought
6 This is another argument that the DOC Defendants only briefly mention in their Brief in Opposition to Renewed Motion to Class Certification and discuss more extensively in their Motion for Summary Judgment. See n.4, supra.
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on behalf of a class does not become moot upon expiration of the named plaintiff’s substantive claim.” United States Parole Comm’n v. Geraghty, 445 U.S. 388, 404 (1980). Consequently, even if Maldonado’s personal claim on the merits is now moot, because he is no longer in the custody of the DOC, “‘he retains a “personal stake” in obtaining class certification sufficient to assure that Art. III values are not undermined.’” Williams v. Sec’y Pa. Dep’t of Corr., 447 F. App’x 399, 403 (3d Cir. 2011) (quoting Geraghty, 445 U.S. at 404). Thus, “so long as a plaintiff files a motion to certify a class when he still has a live claim, the mooting of that claim while the motion is pending precludes the court from reaching the merits but does not preclude it from deciding the certification motion.” Gayle v. Warden Monmouth Cty. Corr. Inst., 838 F.3d 297, 305 (3d Cir. 2016) (citing Holmes v. Pension Plan of Bethlehem Steel Corp., 213 F.3d 124, 135 (3d Cir. 2000); and Geraghty, 445 U.S. at 397). As the Third Circuit has explained, “a plaintiff’s claim that he should represent the class is one that is ‘presented . . . in a concrete factual setting and [with] self-interested parties vigorously advocating opposing positions,’ and such a claim ‘remains as a concrete, sharply presented issue’ even if the plaintiff’s individual claims expire.” Id. at 305-06 (alterations in original) (quoting Geraghty, 445 U.S. at 403-04). Moreover, “Geraghty’s relation-back doctrine encompasses successive, substantially similar motions to certify unless and until certification has been finally resolved on Rule 23 grounds. Id. at 307. We conclude that this “relation back” doctrine applies to Maldonado even though he was paroled prior to the filing of Plaintiffs’ Renewed Class Certification Motion because the first Motion for Class Certification was not decided on the merits, but was withdrawn by agreement of the parties on August 31, 2015. (See August 31, 2015 Stipulation and Order, Docket No. 21.) Since Maldonado was in the custody of the DOC at the time the original Motion for Class Certification was filed, we conclude that, notwithstanding his subsequent parole, he has “a ‘personal stake’ in
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obtaining class certification sufficient to assure that Art. III values are not undermined,” Williams, 447 F. App’x at 403 (quotation omitted), and his claim for class certification is not moot. Plaintiffs have, therefore, satisfied the typicality requirement as to Maldonado. For the above stated reasons, we conclude that the typicality requirement is met as to all three named Plaintiffs in this case.
4. Adequacy of representation “Rule 23(a)(4) requires class representatives to ‘fairly and adequately protect the interests of the class.’” In re Nat’l Football League, 821 F.3d at 428 (quoting Fed. R. Civ. P. 23(a)(4)). This requirement “tests the qualifications of class counsel and the class representatives. It also aims to root out conflicts of interest within the class to ensure that all class members are fairly represented in the negotiations.” Id. With respect to class counsel, “the adequacy requirement assures that counsel possesses adequate experience, will vigorously prosecute the action, and will act at arm’s length from the defendant.” In re Cmty. Bank of N. Virginia Mortg. Lending Practices Litig., 795 F.3d 380, 389 (3d Cir. 2015) (citation omitted). We have reviewed the biographies of Plaintiffs’ counsel that were submitted in connection with the instant Motion and we conclude that class counsel possess more than adequate experience in both representing prisoners and prosecuting class actions. Moreover, class counsel’s representation of Plaintiffs over the more than two years that this case has been ongoing shows that they will vigorously prosecute this action and act at arm’s length from Defendants. We further conclude that Plaintiffs’ counsel are clearly qualified to represent the putative class in this action. With respect to the class representatives, “‘the linchpin of the adequacy requirement is the alignment of interests and incentives between the representative plaintiffs and the rest of the class.’” Id. at 393 (quoting Dewey v. Volkswagen Aktiengesellschaft, 681 F.3d 170, 183 (3d
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Cir. 2012). The DOC Defendants argue that the named Plaintiffs will not be adequate representatives for the same reasons that their claims are not typical of the claims of the putative class. We have already rejected these arguments. We conclude that the interests of the named Plaintiffs are sufficiently aligned with the interests of the putative class that the named Plaintiffs will be adequate representatives. Accordingly, we further conclude that Plaintiffs have satisfied the adequacy of representation requirement.
B. Rule 23(b)(2) Plaintiffs seek certification of the class pursuant to Rule 23(b)(2), which provides that we may certify a class action if “the party opposing the class has acted or refused to act on grounds that apply generally to the class, so that final injunctive relief or corresponding declaratory relief is appropriate respecting the class as a whole.” Fed. R. Civ. P. 23(b)(2). “The Third Circuit has held that Rule 23(b)(2) ‘is almost automatically satisfied in actions primarily seeking injunctive relief’ from systemic violations of basic rights.” P.V. ex rel. Valentin v. Sch. Dist. of Philadelphia, 289 F.R.D. 227, 235 (E.D. Pa. 2013) (quoting Baby Neal, 43 F.3d at 58, 64; and citing Weiss v. York Hosp., 745 F.2d 786, 811 (3d Cir. 1984)). As the Third Circuit has explained, “the injunctive class provision was designed specifically for civil rights cases seeking broad declaratory or injunctive relief for a numerous and often unascertainable or amorphous class of persons.” Baby Neal, 43 F.3d at 59 (quotation omitted). “What is important for purposes of satisfying Rule 23(b)(2) is that the relief sought by the named plaintiffs benefits the entire class.” P.V., 289 F.R.D. at 236 (citing Baby Neal, 43 F.3d at 59). The First Amended Complaint alleges that the DOC’s Hepatitis C Protocol “creates a rationing system for the treatment of inmates with” DAAs, resulting in the denial of treatment with DAAs “to over 98% of inmates with Chronic Hepatitis C, in direct conflict with community
20

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health standards.” (1st Am. Compl. ¶¶ 29-30.) Plaintiffs seek injunctive relief on behalf of the class that would require the DOC to implement a new Hepatitis C treatment policy that meets community health standard and results in the treatment of patients with medically necessary and appropriate DAAs. (Id. ¶ 98.)
We conclude that the class satisfies Rule 23(b)(2) because the DOC’s Hepatitis C Protocol applies to all members of the class and the requested injunctive relief would provide relief to all class members. See Postawko, 2017 WL 3185155, at *13 (finding that class of individuals in the custody of the Missouri Department of Corrections who have been diagnosed with chronic HCV and have not been provided treatment with DAAs satisfied Rule 23(b)(2) because the Missouri Department of Corrections had a policy of refusing to consider DAA treatment for an inmate who did not have sufficiently advanced symptoms of chronic HCV and the injunctive relief sought by the class would require defendants to formulate a new policy in accordance with the current standard of care). See also Hoffer, 323 F.R.D. at 699 (concluding that “certification under Rule 23(b)(2) is appropriate because a single injunction or declaratory judgment would provide relief to each member of the proposed class. Specifically, if this Court enters an injunction forcing Defendant to change FDC’s policies and practices with respect to HCV treatment, then each member of the proposed class will be able to enjoy those changes.”); Stafford, 2018 WL 1140388, at *8 (concluding that proposed class of inmates of the Indiana Department of Corrections diagnosed with chronic HCV satisfied the requirements for certification pursuant to Rule 23(b)(2) “[b]ecause this action seeks injunctive relief to prevent future allegedly illegal deprivations of civil rights” (quotation and citation omitted)).
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Case 2:15-cv-03333-JP Document 107 Filed 05/24/18 Page 22 of 22 IV. CONCLUSION
For the foregoing reasons, we conclude that Plaintiffs have satisfied their burden of “establishing each element of Rule 23 by a preponderance of the evidence.” Marcus, 687 F.3d at 591. Accordingly, we certify the following class for the purpose of seeking injunctive relief pursuant to Rule 23(b)(2): all persons who are currently incarcerated in a Pennsylvania Department of Corrections facility with a diagnosed condition of Chronic Hepatitis C, and who have at least twelve (12) weeks or more remaining to serve on their sentences, and who have a life expectancy of over one year. An appropriate Order follows.
BY THE COURT: /s/ John R. Padova ____________________________ John R. Padova, J.
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 Case 2:15-cv-03333-JP Document 109 Filed 07/12/18 Page 1 of 28

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

SALVATORE CHIMENTI, ET AL.

:

:

v.

:

:

JOHN WETZEL, ET AL.

:

CIVIL ACTION NO. 15-3333

MEMORANDUM

Padova, J.

July 12, 2018

Plaintiffs Salvatore Chimenti, Daniel Leyva, and David Maldonado have brought this

lawsuit on behalf of a class of similarly situated individuals against John Wetzel, the Secretary of

the Pennsylvania Department of Corrections (the “DOC”), and Paul Noel, the Chief Medical

Director of the DOC (collectively the “DOC Defendants”), as well as two companies that have

contracted to provide medical services for the DOC and officials and employees of those

companies (collectively the “Medical Defendants”1), asserting claims regarding the medical care

provided to DOC inmates who have been diagnosed with Hepatitis C viral infections (“HCV”).

Specifically, Plaintiffs contend that the DOC Defendants have violated their rights under the

Eighth Amendment and the Pennsylvania Constitution by adopting a policy for the treatment of

inmates with chronic HCV that fails to provide them with appropriate medical care. Plaintiffs seek

injunctive relief requiring the DOC Defendants to formulate and implement a Hepatitis C treatment

policy that (1) meets community standards of care for patients with chronic HCV; (2) ensures that

inmates with chronic HCV are treated with medically necessary and appropriate direct-acting

antiviral drugs (“DAAs”); and (3) provides ongoing monitoring and medical care in accordance

with the standard of care for such patients’ liver fibrosis and cirrhosis. In addition, Chimenti has

1 The Medical Defendants are Wexford Health Sources, Inc., Correct Care Solutions, LLC, Dr. Jay Cowan, Dr. John Kephart, and Dr. James Frommer.

Case 2:15-cv-03333-JP Document 109 Filed 07/12/18 Page 2 of 28
also brought personal claims for medical malpractice against all Defendants for which he seeks monetary damages. Before the Court is the DOC Defendants’ Motion for Summary Judgment. For the reasons that follow, the Motion is granted in part and denied in part. I. FACTUAL BACKGROUND
Plaintiffs Chimenti, Leyva, and Maldonado all suffer from chronic HCV and were, at the time of the filing of this action, incarcerated in correctional institutions that are part of the DOC. (See Compl. (Docket No. 1) ¶¶ 1-2; DOC Defs.’ Ans. to Compl. (Docket No. 30) ¶¶ 1-2.) Beginning in 2011, the United States Food and Drug Administration (“FDA”) approved DAAs for the treatment of Hepatitis C. (Trooskin Rpt., Pls.’ Ex. A, at 2.) These drugs, which include Sovaldi, Olysio, and Harvoni, are capable of achieving a “sustained virologic response,” which means “the elimination of the virus[,] for more than 90% of patients . . . .” (Id. at 2-3.) Prior to the development of DAAs, the standard of care “was a three-drug treatment containing boceprevir or telaprevir, interferon and ribavirin” that “provided, at best, a 70% cure rate, and was accompanied by significant adverse side effects such as anemia, insomnia, anxiety, depression, nausea, bone pain, muscle [pain], liver failure, joint pain, memory loss, and death.” (Id. at 2.) Plaintiffs’ expert, Dr. Stacey Trooskin, has opined that the use of DAAs is now “the standard of medical care for the treatment of all HCV individuals . . . .” (Id. at 3.)
When Chimenti, Leyva, and Maldonado first asked to be treated with DAAs, their applications were rejected by the DOC. Chimenti began requesting treatment with DAAs in late 2013, but Defendants denied his requests. (Pls.’ Counterstatement of Add’l Facts (“PCSAF”) ¶¶ 225-30; DOC Defs.’ Resp. to PCSAF (“DRPCAF”) ¶¶ 225-30.) Chimenti filed grievances asking for treatment with DAAs in early 2014, but his grievances were denied because the DOC did not have a Hepatitis C protocol and had put all Hepatitis C treatment on hold. (PCSAF ¶¶ 226-28;
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DRPCAF ¶¶ 226-28.) Chimenti has suffered from Stage 4 cirrhosis since at least 2000. (Pls.’ Ex. U at 5.) In October 2015, Chimenti was found to have a liver mass that was possibly cancerous. (Chimenti Dep., Pls.’ Ex. R, at 37-39.) He was pressured to have a biopsy of the mass, even though a biopsy was not the standard of care and a radiologist refused to do the biopsy. (Id.) The lesion is not considered to be cancerous at this time. (Id. at 40; Pls.’ Ex. Q at 1.) Chimenti was treated with DAAs beginning in October 2016. (PCSAF ¶ 236; DRPCAF ¶ 236.) Notwithstanding this treatment, he currently suffers from diabetes that that may be related to his HCV, as well as severe fatigue and memory problems related to hepatic encephalopathy. (Pls.’ Ex. Q at 1.)
Leyva filed a grievance with the DOC on January 13, 2015, asking to be treated with the new Hepatitis C drugs. (Pls.’ Ex. V at 2.) The DOC upheld his grievance, but told him that it was evaluating its treatment options and developing a new treatment protocol and, in the meantime, would only monitor patients with HCV. (Id. at 3.) On March 4, 2015, Leyva sent a letter to the DOC expressing his concern about having to wait for treatment while the DOC developed a new treatment protocol for Hepatitis C. (See id. at 4.) The DOC responded that it was continuing to monitor inmates with HCV while it evaluated treatment options. (Id.) On April 17, 2015, Leyva filed a new grievance, asking to be treated with Harvoni. (Id. at 5.) That grievance was denied and the Secretary’s Office of Inmate Grievances and Appeals denied Leyva’s third level appeal of that decision on September 8, 2015. (Id. at 7-19.) Leyva still has not received treatment with DAAs. (lst Am. Class Action Compl. (“1st Am. Compl.”) (Docket No. 50) ¶ 68; DOC Defs.’ Ans. to lst Am. Compl. (Docket No. 93) ¶ 13.)
Maldonado also filed a grievance asking to be treated with the latest DAAs. (DOC Defs.’ Ex. B; Pls.’ Ex. F.) The DOC rejected his grievance and has not treated Maldonado with DAAs.
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(DOC Defs.’ Ans. to 1st Am. Compl. ¶ 16.) Maldonado was paroled on May 15, 2017 and is not currently incarcerated by the DOC. (DOC Defs.’ Ex. H at 2.)
The DOC issued an Interim Hepatitis C Protocol in November 2015 and began treating some inmates with DAAs. (DOC Defs.’ Statement of Material Facts (“SMF”) ¶ 53; Pls.’ Resp. to SMF (“PRSMF”) ¶ 53.) The DOC issued a new protocol for the treatment of HCV on November 7, 2016, the “Hepatitis C Protocol.” (SMF ¶ 40; PRSMF ¶ 40.) Pursuant to the Hepatitis C Protocol, the DOC screens all inmates for HCV with an antibody test and confirms HCV diagnosis with additional testing. (DOC Defs.’ Ex. J §§ B.1, B.2.) The DOC also advises inmates who have HCV regarding the Hepatitis C Protocol, and keeps track of inmates who have HCV. (Id. §§ B.4., and C.) The DOC enters all inmates with chronic HCV into its Liver Disease Chronic Care Clinic. (Id. § G.1.)
Pursuant to the Hepatitis C Protocol, the DOC uses an infected inmates’ Aspartate Aminotransferase to Platelet Ratio Index (“APRI”) score to estimate hepatic fibrosis, predict the presence of cirrhosis, and prioritize treatment for HCV. (Id. §§ D.1.b, H.4.) Fibrosis is designated by Metavir score, which ranges from F0 to F4: F0 shows no fibrosis, F1 shows periportal inflammation with minimal fibrosis, F2 shows periportal fibrosis with mild bridging, F3 shows periportal fibrosis with moderate bridging, and F4 represents a cirrhotic liver. (Cowan Dep., DOC Defs.’ Ex. L, at 49.) APRI scores are indirect markers of fibrosis.2 (Id. at 43.) “An APRI score greater than 2.0 suggests a fibrosis score of F3 or F4. . . . An APRI score between 1.0 and 2.0 suggests a fibrosis score of F2. . . . An APRI score less than 1.0 suggests a fibrosis score of F0 or F1.” (Noel Decl., DOC Defs.’ Ex. N, ¶¶ 19-22.) As Dr. Noel has explained, “APRI scores are
2 Both liver biopsy and shearwave elastograpy are more accurate tests for determining a patient’s fibrosis level. (See Cowan Dep., DOC Defs.’ Ex. L, at 43-44; Noel Dep., DOC Defs.’ Ex. K, at 110; Kendig Dep., Pls.’ Ex. K, at 55-56.)
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more accurate at the end ranges, i.e. greater than 2.0 and less than 1.0 (F3, F4 and F0, F1.)” (Id. ¶ 23.) APRI scores at the 1.5 to 2 level only have “a sensitivity accuracy of about 48 percent” and an APRI score of 1 would miss approximately 23% of patients with cirrhosis. (Cowan Dep., DOC Defs.’ Ex. L, at 42.)
The Hepatitis C Protocol requires follow-up appointments at the Chronic Care Clinic for inmates who are diagnosed with Metavir scores of F0 to F2 every six months, for those with Metavir scores of F3 every three months, and for those with Metavir scores of F4 every month. (DOC Defs.’ Ex. J § G.3.d.) While all patients diagnosed with chronic HCV are followed at the Chronic Care Clinic, they are not all treated with DAAs to cure their HCV. Instead, the Hepatitis C Protocol requires the DOC to treat the sickest inmates first, and it bases treatment decisions on an inmate’s Metavir scores, as estimated by APRI scores. (SMF ¶¶ 45, 53; PRSMF ¶¶ 45, 53; DOC Defs.’ Ex. J § H.4.) According to the Hepatitis C Protocol, inmates with cirrhosis are Priority Level 1 – the highest priority for treatment with DAAs. (DOC Defs.’ Ex. J § H.4.a.) Inmates with APRI scores greater than 2, or who have shown to have Metavir scores of F3 on a liver biopsy, as well as inmates who are coinfected with Hepatitis B or HIV, are Priority Level 2. (Id. § H.4.b.) Inmates shown to have Metavir scores of F2 on liver biopsy, APRI scores of at least 1.5 and less than 2.0, or who have diabetes, are Priority Level 3. (Id. § H.4.c.) Inmates with Metavir scores of F0 to F1 on liver biopsy are Priority Level 4, as are all other inmates with HCV infections who meet the DOC’s criteria for treatment. (Id. § H.4.d.)
Fewer than 10% of DOC inmates with chronic HCV have been treated with DAAs under the Hepatitis C Protocol. (PCSAF ¶ 178; DRPCAF ¶ 178.) As of September 20, 2017, the DOC held 7,521 inmates who have been infected with Hepatitis C, 5,265 of whom have chronic HCV.
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(Wenhold Decl., DOC Defs.’ Ex. F, ¶¶ 15-16.) The DOC has treated 297 of its inmates who have
chronic HCV with DAAs. (Id. ¶ 17.)
The First Amended Complaint states four claims for relief on behalf of the following class:
all persons who are currently incarcerated in a Pennsylvania Department of Corrections facility with a diagnosed condition of Chronic Hepatitis C, and who have at least twelve (12) weeks or more remaining to serve on their sentences, and who have a life expectancy of over one year.
(5/24/18 Order, Docket No. 108.) Count I asserts a claim pursuant to 42 U.S.C. § 1983 against the DOC Defendants and two of the Medical Defendants3 on behalf of the three named Plaintiffs and
the Class for deliberate indifference to the serious medical needs of prisoners infected with HCV
in violation of the Eighth Amendment to the United States Constitution. (1st Am. Compl. ¶ 90.)
Count II asserts a claim for injunctive relief against Wetzel on behalf of the three named Plaintiffs
and the Class for violation of Article I, § 13 of the Pennsylvania Constitution. (Id. ¶ 92.) Count
III asserts a claim against Dr. Noel and the Medical Defendants for medical malpractice on behalf
of Chimenti. (Id. ¶ 94.) Count IV asserts a claim against Correct Care Solutions, LLC and
Wexford Health Sources, Inc. (two of the Medical Defendants) for medical malpractice on behalf
of Chimenti. (Id. ¶ 96.) Plaintiffs seek an injunction on behalf of themselves and the Class
ordering the DOC to:
(a) formulate and implement a Hepatitis C treatment policy that meets the community standards of care for patients with Hepatitis C, (b) that members of the Class be treated with medically necessary and the appropriate direct-acting antiviral drugs based on individual medical testing and medical evaluation regarding each individual’s Hepatitis C status, and (c) that members of the [C]lass receive ongoing monitoring and medical care per the standard of care for their individual level of liver fibrosis and cirrhosis, including but not limited to appropriate access to and
3 Count I asserts a claim for both injunctive relief and monetary damages. Plaintiffs seek injunctive relief in Count I on behalf of themselves and the Class against the DOC Defendants only. Plaintiffs seek monetary damages in Count I only on behalf of Chimenti and they seek to obtain damages from Dr. Kephart and Dr. Frommer as well as the DOC Defendants.
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evaluation by a hepatologist and assessment regarding their need for partial or full liver transplant. (Id. ¶ 98.) Plaintiffs also seek compensatory and punitive damages for Chimenti, reasonable attorney’s fees and costs, and such other relief as the Court deems just and equitable. (Id. ¶¶ 99102.) II. LEGAL STANDARD Summary judgment is appropriate “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). An issue is “genuine” if “the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A factual dispute is “material” if it “might affect the outcome of the suit under the governing law.” Id. “[A] party seeking summary judgment always bears the initial responsibility of informing the district court of the basis for its motion, and identifying those portions of [the record] which it believes demonstrate the absence of a genuine issue of material fact.” Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). Where the nonmoving party bears the burden of proof on a particular issue at trial, the movant’s initial Celotex burden can be met simply by “pointing out to the district court” that “there is an absence of evidence to support the nonmoving party’s case.” Id. at 325. After the moving party has met its initial burden, the adverse party’s response “must support the assertion [that a fact is genuinely disputed] by: (A) citing to particular parts of materials in the record . . . ; or (B) showing that the materials [that the moving party has] cited do not establish the absence . . . of a genuine dispute.” Fed. R. Civ. P. 56(c)(1). Summary judgment is appropriate if the nonmoving party fails to respond with a factual showing “sufficient to establish the existence of an element essential to that party’s case, and on which that party will bear the burden of proof at trial.” Celotex, 477 U.S. at 322. In ruling on a summary judgment motion, we consider “the
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facts and draw all reasonable inferences in the light most favorable to . . . the party who oppose[s] summary judgment.” Lamont v. New Jersey, 637 F.3d 177, 179 n.1 (3d Cir. 2011) (citing Scott v. Harris, 550 U.S. 372, 378 (2007)). III. DISCUSSION
A. Count I The DOC Defendants move to dismiss Count I on the grounds of mootness, failure to exhaust administrative remedies, lack of standing, and because the record does not support Plaintiffs’ claims that they were deliberately indifferent to Plaintiffs’ serious medical needs in violation of the Eighth Amendment. We address these arguments in turn.
1. Mootness The DOC Defendants argue that we should dismiss Maldonado’s request for injunctive relief as to Count I because it is moot. As we mentioned above, Maldonado was paroled on May 15, 2017 and is not currently incarcerated by the DOC. (DOC Defs.’ Ex. H at 2.) “Generally, courts have held that an inmate’s release from a correctional institution makes his or her claims for injunctive relief moot.” Sutton v. City of Phila., 21 F. Supp. 3d 474, 480-81 (E.D. Pa. 2014) (citations omitted). “The mootness doctrine requires that an actual controversy exist at all stages of review, not merely at the time the complaint is filed.” Doe v. Delie, 257 F.3d 309, 313 (3d Cir. 2001) (citing New Jersey Turnpike Auth. v. Jersey Cent. Power & Light, 772 F.2d 25, 31 (3d Cir. 1985)). The United States Court of Appeals for the Third Circuit has explained that “‘mootness has two aspects: (1) the issues presented are no longer “live” or (2) the parties lack a cognizable interest in the outcome.’” Id. (quoting New Jersey Turnpike Auth., 772 F.2d at 31). Since Maldonado has been released, he is no longer in the custody of the DOC and any injunctive relief
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regarding medical treatment provided by the DOC “would have no impact on him, and therefore his equitable claims are moot.” Id.
Plaintiffs contend that Maldonado’s claims fall under the “inherently transitory” exception to the mootness doctrine. However, the cases upon which they rely concern whether a putative class representative plaintiff can continue to seek class certification after his individual claim has become moot. See Gerstein v. Pugh, 420 U.S. 103, 110 n.11 (1975); United States Parole Comm’n v. Geraghty, 445 U.S. 388, 404 (1980); Richardson v. Bledsoe, 829 F.3d 273, 279 (3d Cir. 2016). Plaintiffs have pointed to no authority for the proposition that an individual can continue to seek relief as to his own personal claim once that claim has become moot.
The DOC Defendants concede that Maldonado has “standing to bring and maintain this action on behalf of the class members regardless of [his] own individual claims being moot.” (DOC Defs.’ Reply at 18.) They argue only that his individual claim should be dismissed as moot because he is no longer incarcerated by the DOC. We agree. Accordingly, we grant the DOC Defendants’ Motion for Summary Judgment as to their argument that Maldonado’s individual claim for injunctive relief in Count I of the First Amended Complaint should be dismissed as moot.
The DOC Defendants also argue that we should dismiss Chimenti’s claim for injunctive relief in Count I as moot because he has already received the requested relief. See Hollihan v. Pa. Dep’t of Corr., 159 F. Supp. 3d 502, 509 (M.D. Pa. 2016) (dismissing claim for injunctive relief seeking an order requiring the DOC to provide plaintiff with cataract surgery after plaintiff received the cataract surgery). As we discussed above, Plaintiffs seek an injunction that will require Defendants to implement a Hepatitis C treatment policy that meets community standards of care; treat members of the Class with medically necessary and appropriate DAAs and provide ongoing monitoring and medical care to class members that is appropriate for their individual level
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of liver fibrosis and cirrhosis, including evaluation by a hepatologist and assessment regarding their need for partial or full liver transplant. (1st Am. Compl. ¶ 98.) Chimenti has already received treatment with DAAs and, accordingly, no longer personally needs the second of the three items in the requested injunction. (PCSAF ¶ 236; DRPCAF ¶ 236.) However, there is no basis on the record before us upon which we could determine that Chimenti has no interest in requiring the DOC Defendants to formulate and implement a policy for the treatment of Hepatitis C that meets community standards of care or that he no longer needs monitoring and medical care for cirrhosis or liver fibrosis and access to treatment by a hepatologist. Indeed, Chimenti’s medical expert, Dr. Bennet Cecil, has opined that Chimenti still has a liver lesion and suffers from diabetes, severe fatigue, and memory problems relating to hepatic encephalopathy. (Pls.’ Ex. Q at 1.) We conclude that Chimenti’s claim for injunctive relief is not moot and we deny the DOC Defendants’ Motion for Summary Judgment as to this issue.
2. Exhaustion of Administrative Remedies The DOC Defendants argue that they are entitled to summary judgment as to Leyva’s claim for injunctive relief in Count I because he failed to exhaust his administrative remedies prior to filing this lawsuit. The Prison Litigation Reform Act (“PLRA”) provides that “[n]o action shall be brought with respect to prison conditions under section 1983 of this title, or any other Federal law, by a prisoner confined in any jail, prison, or other correctional facility until such administrative remedies as are available are exhausted.” 42 U.S.C. § 1997e(a). Specifically, the DOC Defendants argue that Leyva did not exhaust his administrative remedies prior to filing suit because the DOC’s Secretary’s Office of Inmate Grievances and Appeals did not issue a decision at the third and final level with respect to Leyva’s second grievance until September 8, 2015, nearly three months after this action was initiated on June 12, 2015. “If exhaustion is incomplete when
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an inmate files suit, dismissal is mandatory.” Turner v. Sec’y Pa. Dep’t of Corr., 683 F. App’x 180, 182 n.1 (3d Cir. 2017) (citing Porter v. Nussle, 534 U.S. 516, 524 (2002); and Nyhuis v. Reno, 204 F.3d 65, 77 n.12 (3d Cir. 2000)). Moreover, “[a]n inmate cannot cure non-compliance with [the PLRA] by exhausting remedies after filing his complaint.” Id. (citation omitted).
However, we concluded in our May 24, 2018 Memorandum and Opinion granting Plaintiffs’ Motion for Class Certification that the doctrine of vicarious exhaustion applies in this case. See Chimenti v. Wetzel, Civ. A. No. 15-3333, 2018 WL 2388665, at *5 (E.D. Pa. May 24, 2018). The United States Court of Appeals for the Eleventh Circuit has explained that, pursuant to this doctrine, “a class of prisoner-plaintiffs certified under Rule 23(b)(2) satisfies the PLRA’s administrative exhaustion requirement through ‘vicarious exhaustion,’ i.e., when ‘one or more class members ha[s] exhausted his administrative remedies with respect to each claim raised by the class.’” Chandler v. Crosby, 379 F.3d 1278, 1287 (11th Cir. 2004) (alteration in original) (quoting Jones ‘El v. Berge, 172 F. Supp. 2d 1128, 1133 (W.D. Wis. 2001); and citing Hattie v. Hallock, 8 F. Supp. 2d 685, 689 (N.D. Ohio 1998)). Vicarious exhaustion “advances the purpose of administrative exhaustion, which . . . ‘is to put the [administrative authority] on notice of all issues in contention and to allow the [authority] an opportunity to investigate those issues.’” Id. (alterations in original) (quoting Griffin v. Carlin, 755 F.2d 1516, 1531 (11th Cir. 1985)). Since Defendants do not dispute that both Chimenti and Maldonado exhausted their administrative remedies prior to filing suit pursuant to the PLRA, we conclude Leyva’s PLRA exhaustion requirement is satisfied through vicarious exhaustion. We thus deny the DOC Defendants’ Motion for Summary Judgment as to their argument that Leyva’s claim for injunctive relief in Count I should be dismissed for failure to exhaust administrative remedies.
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Defendants also argue that we should dismiss the claims brought in Count I as to all but seven of the members of the Class, because only seven members of the Class properly exhausted their administrative remedies pursuant to the PLRA before this action was filed. As we discussed above, we have concluded that vicarious exhaustion applies in this case. Since there is no dispute that both Chimenti and Maldonado exhausted their administrative remedies pursuant to the PLRA prior to filing suit, we conclude that the PLRA exhaustion requirement is satisfied through vicarious exhaustion as to all of the members of the class who did not personally exhaust their administrative remedies with respect to the claims asserted in Count I of the First Amended Complaint. We thus deny the DOC Defendants’ Motion for Summary Judgment as to their argument that the claims asserted in Count I should be dismissed as to all but seven members of the Class for failure to exhaust administrative remedies.
3. Standing Defendants argue that future inmates of the DOC lack standing to assert claims in this case and should be dismissed as plaintiffs in this action. Specifically, Defendants contend that the definition of the class includes individuals who are not yet inmates in the custody of the DOC and that the named Plaintiffs lack standing to assert claims on behalf of those individuals. However, the definition of the class includes only “all persons who are currently incarcerated in a Pennsylvania Department of Corrections facility with a diagnosed condition of chronic Hepatitis C.” (5/24/18 Order, Docket No. 108 (emphasis added).) Since the class does not include any individuals who are not “currently incarcerated” in a DOC facility, we deny the DOC Defendants’ Motion for Summary Judgment as to this argument.
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4. Deliberate indifference The DOC Defendants also argue that they are entitled to the entry of summary judgment in their favor as to Count I because the factual record does not support Plaintiffs’ claim that the DOC Defendants were deliberately indifferent to Plaintiffs’ serious medical needs. Count I asserts a claim pursuant to 42 U.S.C. § 1983 for violation of Plaintiffs’ rights under the Eighth Amendment based on the denial of medical care for their chronic HCV. Section 1983 provides, in pertinent part, as follows: Every person who, under color of any statute, ordinance, regulation, custom, or usage, of any State or Territory or the District of Columbia, subjects, or causes to be subjected, any citizen of the United States or other person within the jurisdiction thereof to the deprivation of any rights, privileges, or immunities secured by the Constitution and laws, shall be liable to the party injured in an action at law, suit in equity, or other proper proceeding for redress . . . . 42 U.S.C. § 1983. “Section 1983 provides remedies for deprivations of rights established in the Constitution or federal laws. It does not, by its own terms, create substantive rights.” Kaucher v. Cty. of Bucks, 455 F.3d 418, 423 (3d Cir. 2006) (footnote omitted) (citing Baker v. McCollan, 443 U.S. 137, 145 n.3 (1979)). Consequently, in order to obtain relief pursuant to § 1983, “a plaintiff must demonstrate [that] the defendant, acting under color of state law, deprived him or her of a right secured by the Constitution or the laws of the United States.” Id. (citing Am. Mfrs. Mut. Ins. Co. v. Sullivan, 526 U.S. 40, 49-50 (1999), and Mark v. Borough of Hatboro, 51 F.3d 1137, 1141 (3d Cir. 1995)). Count I alleges that the Defendants’ “acts and omissions in failing to provide adequate medical care constitute a deliberate indifference to the serious medical needs of prisoners infected with Hepatitis C, thereby establishing a violation of the Eighth Amendment to the United States Constitution.” (1st. Am. Compl. ¶ 90.) The Eighth Amendment’s right to be free from cruel and unusual punishment, which applies to the states via the Fourteenth Amendment, Robinson v.
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California, 370 U.S. 660, 675 (1962), “imposes duties on [prison] officials, who must . . . ensure that inmates receive . . . medical care, and must ‘take reasonable measures to guarantee the safety of the inmates.’” Farmer v. Brennan, 511 U.S. 825, 832 (1994) (quoting Hudson v. Palmer, 468 U.S. 517, 526-27 (1984) (additional citations omitted)). To succeed on a claim under the Eighth Amendment for denial of medical care, a plaintiff must establish that a defendant showed “[1] deliberate indifference to [2] serious medical needs of [a] prisoner[ ].” Estelle v. Gamble, 429 U.S. 97, 104 (1976). Courts have consistently held that “mere allegations of malpractice” are not sufficient to allege “deliberate indifference.” Id. at 106 n.14.
“Deliberate indifference can be shown by a prison official ‘intentionally denying or delaying access to medical care or intentionally interfering with the treatment once prescribed.’” Rhines v. Bledsoe, 388 F. App’x 225, 227 (3d Cir. 2010) (quoting Estelle, 429 U.S. at 104-05). “A medical need is serious if it ‘has been diagnosed by a physician as requiring treatment or one that is so obvious that a lay person would easily recognize the necessity for a doctor’s attention.’” Id. (quoting Monmouth Cty. Corr. Inst. Inmates v. Lanzaro, 834 F.2d 326, 347 (3d Cir. 1987)). Moreover, the medical need must be such that “‘a failure to treat can be expected to lead to substantial and unnecessary suffering, injury, or death.’” Tsakonas v. Cicchi, 308 F. App’x 628, 632 (3d Cir. 2009) (quoting Colburn v. Upper Darby Twp., 946 F.2d 1017, 1023 (3d Cir. 1991)).
A prison official acts with deliberate indifference to a serious medical need “when he knows of and disregards an excessive risk to inmate health or safety.” Brown v. Thomas, 172 F. App’x 446, 450 (3d Cir. 2006) (citing Farmer, 511 U.S. at 837). “The official must be aware of the facts from which an inference could be drawn that a substantial risk of serious harm exists, and he must also draw the inference.” Id. (citation omitted). The Supreme Court has instructed that we should distinguish “‘deliberate indifference to serious medical needs of prisoners,’” from
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“‘negligen[ce] in diagnosing or treating a medical condition,’” because “only the former violates the [Cruel and Unusual Punishments] Clause.” Farmer, 511 U.S. at 835 (first alteration in original) (quoting Estelle, 429 U.S. at 106). Therefore “Eighth Amendment liability requires ‘more than ordinary lack of due care for the prisoner’s interests or safety,’” id. (quoting Whitley v. Albers, 475 U.S. 312, 319 (1986)), and “[a]llegations of medical malpractice are not sufficient to establish a Constitutional violation.” Spruill v. Gillis, 372 F.3d 218, 235 (3d Cir. 2004). The Third Circuit has “‘found “deliberate indifference” in a variety of circumstances, including where the prison official (1) knows of a prisoner’s need for medical treatment but intentionally refuses to provide it; (2) delays necessary medical treatment based on a non-medical reason; or (3) prevents a prisoner from receiving needed or recommended medical treatment.’” Parkell v. Danberg, 833 F.3d 313, 337 (3d Cir. 2016) (quoting Rouse v. Plantier, 182 F.3d 192, 197 (3d Cir. 1999)). The DOC Defendants argue that Plaintiffs cannot establish that they have been deliberately indifferent to inmates’ serious medical needs because the DOC has a Hepatitis C Policy and it has treated, or is in the process of treating, all inmates with chronic HCV who have serious medical needs.
a. The Hepatitis C Protocol The DOC Defendants contend that they are entitled to summary judgment as to Count I of the First Amended Complaint because the DOC has adopted a Hepatitis C Protocol that provides for treatment with DAAs for some inmates with chronic HCV and thus, they are not deliberately indifferent to inmates’ serious medical needs. As we described above, after first denying treatment with DAAs to all inmates with chronic HCV, the DOC adopted the Interim Hepatitis C Protocol in November 2015, pursuant to which some, but not all, inmates with cirrhosis were prioritized for treatment with DAAs. (SMF ¶ 53; PRSMF ¶ 53; Pls.’ Ex. P § F.) A year later, on November 7, 2016, the DOC adopted the Hepatitis C Protocol, which prioritizes DAA treatment of inmates with
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chronic HCV. (SMF ¶ 40; PRSMF ¶ 40; DOC Defs.’ Ex. J § H..) Pursuant to these Protocols, the DOC has treated inmates with Metavir scores of F3 and F4. (Noel Decl., DOC Defs.’ Ex. N., ¶ 14.) The DOC intends to continue treating inmates with Metavir scores of F3 and F4 and expects to treat inmates with Metavir scores of F2 in 2018. (Id. ¶¶ 14-15.)
Plaintiffs maintain that Defendants are not entitled to summary judgment as to Count I of the First Amended Complaint just because the DOC has adopted the Hepatitis C Protocol. Plaintiffs contend both that the DOC Defendants can always change the Protocol once this case is over, and that the adoption of the Protocol itself was deliberately indifferent to the serious medical needs of inmates with chronic HCV. Plaintiffs rely on Knox v. Service Employees Int’l Union, Local 1000, 567 U.S. 298 (2012), in which the Supreme Court explained that “[t]he voluntary cessation of challenged conduct does not ordinarily render a case moot because a dismissal for mootness would permit a resumption of the challenged conduct as soon as the case is dismissed.” Id. at 307 (citing City of Mesquite v. Aladdin’s Castle, Inc., 455 U.S. 283, 289 (1982)); see also Already, LLC v. Nike, Inc., 568 U.S. 85, 91 (2013) (“[A] defendant cannot automatically moot a case simply by ending its unlawful conduct once sued. Otherwise, a defendant could engage in unlawful conduct, stop when sued to have the case declared moot, then pick up where he left off, repeating this cycle until he achieves all his unlawful ends.” (citing City of Mesquite, 455 U.S. at 289)). Consequently, “‘a defendant claiming that its voluntary compliance moots a case bears the formidable burden of showing that it is absolutely clear the allegedly wrongful behavior could not reasonably be expected to recur.’” Sourovelis v. City of Phila., 103 F. Supp. 3d 694, 701 (E.D. Pa. 2015) (quoting Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 190, (2000)).
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Plaintiffs argue that the Hepatitis C Protocol is an administrative protocol that has no force of law and can be changed, amended, or terminated at any time and, thus, there is nothing to prevent the DOC from stopping treatment of inmates with DAAs in the future. The DOC Defendants have put forth no evidence that shows that “the allegedly wrongful behavior could not reasonably be expected to recur.” Sourovelis, 103 F. Supp. 3d at 701 (quotation omitted).
Plaintiffs also argue that the record shows that the DOC Defendants adopted the current protocol because it limits the number of inmates who will be treated with DAAs for reasons other than medical need. There is record evidence that the DOC chose not to treat any inmates with DAAs in 2014 because of the cost. (Noel Dep., DOC Defs.’ Ex. K, at 80-81.) There is also evidence that the DOC’s restriction of treatment with DAAs to inmates with Metavir scores of F3 and F4 under the Hepatitis C Protocol was based on the cost of treatment, not medical recommendations or the treatment protocols used by other prisons. Indeed, Dr. Noel rejected advice that he received from Dr. Scharff, then the DOC Chief of Clinical Services, Bureau of Health Care Services, and Eugene Ginchereau, Assistant State Medical Director, that patients with an APRI score of 1.0 or greater should be treated with DAAs, informing Dr. Scharff and Mr. Gincherau that: “[o]ut of 6,000 DOC inmates who were Hep C, 700 had an APRI score of greater than 1.0. For purposes of establishing the magnitude of treating them all, it would be 700 x $100,000 or $70 million . . . . Somehow, I’m going to have to further prioritize this number.” (Id. at 81-82; Pls.’ Ex. L.) Dr. Noel confirmed during his deposition that the only prioritization factor that he was considering at that time was cost. (Noel Dep. at 82.) So, in Dr. Noel’s opinion, even though an APRI score of 1.0 might qualify an inmate for DAA treatment in other prison systems, the DOC would have to “find a higher APRI score.” (Id.) An email that Dr. Noel sent to Dr.
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Cowan, Rich Wenhold, Christopher Oppman,4 and others on February 18, 2016, shows that Noel
was guided by the desire to limit the number of inmates who would be eligible for treatment with
DAAs when he helped to develop the Hepatitis C Protocol:
Carl, Thanks for sharing your recommendations on how to update our Hepatitis C Protocol. I do not doubt the elastograhy science or the improvements in defending the Protocol, but I need to operationalize this within our current fiscal realities. It does not help us if the use of elastography provides us a bucket of potential patients which is too large to treat in a timely fashion.5
(Pls.’ Ex. L.)
We conclude that there is evidence on the record that the DOC’s prioritization of its
treatment of inmates with DAAs pursuant to the Hepatitis C Protocol is influenced by the cost of
that treatment rather than solely by the medical needs of inmates with chronic HCV and, thus, that
the DOC has delayed necessary medical treatment for a non-medical reason. See Parkell, 833 F.3d
at 337 (citation omitted). 6 Moreover, there is no record evidence that there is anything to prevent
4 Dr. Jay Cowan is the statewide Medical Director for Correct Care Solutions, LLC. (1st Am. Compl. ¶ 13; Medical Defs.’ Ans. to 1st Am. Compl. ¶ 13.) Rich Wenhold is the Infection Control Coordinator at the DOC. (Wenhold Decl., Pls.’ Ex. I, ¶ 2.) Christopher H. Oppman is the Deputy Secretary of Administration for the DOC and was previously the Director of the Bureau of Health Care Services of the DOC. (Oppman Dep., DOC Defs.’ Ex. M, at 6; Pls.’ Ex. E.)
5 Elastopgraphy “images the liver tissue and provides a measure of fibrosis or cirrhosis.” (Trooskin Rpt., Pls.’ Ex. A, at 8.) It is a more precise test than the APRI score. (Id.; Noel Dep. at 110-11.) Elastography shows the stiffness or elasticity of the liver and gives a reading that can be equated to a fibrosis score of F0 to F4. (Cowan Dep., DOC Defs.’ Ex. L, at 43-44.) Dr. Cowan is of the opinion that elastography is “becoming the kind of a new gold standard . . . in . . . determining the F score.” (Id. at 44.) The DOC has purchased an elastography machine, which is located at SCI Benner, and which the DOC can use to test up to 15 patients per month. (Noel Dep. at 113.) The DOC has no plans to purchase additional elastography machines. (Id.)
6 The DOC Defendants argue that reliance on non-medical factors in treatment decisions, such as cost and administrative convenience, does not equate to deliberate indifference to serious medical needs. However, “while ‘administrative convenience and cost may be, in appropriate circumstances, permissible factors for correctional systems to consider in making treatment decisions, the Constitution is violated when they are considered to the exclusion of reasonable medical judgment about inmate health.’” Allah v. Thomas, 679 F. App’x 216, 220 (3d Cir. 2017)
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the DOC from changing the Hepatitis C Protocol after the conclusion of this litigation. Under these circumstances, we conclude that there is a genuine issue of material fact regarding whether DOC Defendants are deliberately indifferent to the serious medical needs of inmates with chronic HCV notwithstanding their adoption of the Hepatitis C Protocol. Accordingly, we decline to grant summary judgment to the DOC Defendants with respect to Count I because the DOC has adopted the Hepatitis C Protocol.
b. Inmates with F0 to F1 fibrosis scores The DOC Defendants argue that they are entitled to summary judgment as to Count I because those inmates who do not qualify for treatment with DAAs under the Hepatitis C Protocol do not currently have serious medical needs. The DOC Defendants rely on the report of their expert, Dr. Kendig, who opined that patients with Metavir scores of F0 to F2 “are at low risk for rapid progression to severe liver disease, [and] therefore they are not at imminent risk of physical injury without immediate treatment with DAA therapies.” (Kendig Rpt., DOC Defs.’ Ex. Q, at 5.) Dr. Kendig has further opined that prioritizing treatment of DAAs to first treat only inmates with Metavir scores of F3-F4 is appropriate: This prioritization approach is warranted in the correctional setting due to the enormous number of inmates who have chronic HCV infection; the associated logistical and security challenges for immediately treating all inmates with HCV; the questionable cost effectiveness of immediately treating persons with HCV who have no or minimal liver disease; [and] the very high treatment costs for DAA therapies . . . .
(quoting Roe v. Elyea, 631 F.3d 843, 863 (7th Cir. 2011)). Since the record contains evidence that Dr. Noel considered cost to the exclusion of other factors in formulating the Hepatitis C Protocol (see Noel Dep. at 82), we conclude that there is record evidence that the DOC Defendants were deliberately indifferent to the medical needs of inmates with HCV in their formulation of the Hepatitis C Protocol.
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(Id.) Dr. Kendig concluded that “the Pennsylvnaia DOC hepatitis C protocol is medically appropriate and is consistent with the correctional standard of health care as of July 2017” and that the Hepatitis C Protocol “does not place inmates with chronic HCV infection at a substantial and unnecessary risk for severe illness and death.” (Id.)
The DOC Defendants also contend that their prioritization of inmates for treatment with DAAs is not inconsistent with the medical treatment given to individuals infected with HCV outside of the correctional setting. The DOC Defendants rely on evidence that some insurance companies restrict treatment with DAAs based on “disease severity as measured by Metavir Score.” (Trooskin Dep., DOC Defs.’ Ex. T, at 27.) In addition, prior to July 1, 2017, Pennsylvania’s Medicaid program did not pay for treatment with DAAs for persons infected with HCV who had Metavir scores of F1 or F0. (Id.)
Plaintiffs argue that there is evidence of record that inmates with chronic HCV who have Metavir scores of F0 to F2 do have serious medical needs and should be treated with DAAs. The American Association for the Study of Liver Diseases (“AASLD”), “recommend[s] treatment for all patients with chronic HCV infection, except those with a short life expectancy that cannot be remediated by HCV treatment, liver transplantation, or another directed therapy.” (Pls.’ Ex. C at 1.) According to the AASLD, “[p]atients who are cured of their HCV infection experience numerous health benefits, including a decrease in liver inflammation . . . and a reduction in the rate of liver fibrosis progression.” (Id. at 2 (citation omitted).) In addition, studies reviewed by the AASLD showed that curing HCV, referred to as sustained virologic response (“SVR”), resulted in the resolution of cirrhosis in 49% of cases reported, a “70% reduction in the risk of liver cancer,” and a “90% reduction in the risk of liver-related mortality and liver transplantation.” (Id. (citations omitted).) The AASLD also reported that studies show clear benefits from treating patients at the
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early stages of fibrosis, specifically patients with Metavir scores less than F2. According to the
AASLD, “a long-term follow-up study” showed that patients at Metavir stage F0 or F1 fibrosis
who achieved SVR and who were followed for up to twenty years had better 15-year survival rates
than patients at Metavir stage F0 or F1 who were not treated. (Id.) The AASLD has also
recognized that “[t]reatment delay may decrease the benefit of SVR.” (Id.)
Dr. Trooskin has opined that patients with Metavir scores below F2 are at risk for serious
medical problems if they remain untreated:
A significant number of persons with chronic HCV who have no or mild fibrosis (commonly described as F0-F1) will progress to cirrhosis in the absence of treatment. Currently, there is no way to predict who in this cohort will develop advanced liver disease. Delaying treatment for patients until they develop advanced liver disease leads to significant suffering, increased risk of cancer, need for liver transplants, and death. Patients who are unable to obtain curative treatment are at high risk for anxiety, illness uncertainty (the inability to determine the meaning of illness-related events), and depression, regardless of fibrosis stage. Patients who are cured of HCV report a significant improvement in their mental well-being. As the disease progresses, so does the risk of a host of medical problems, including HCV-associated heart disease, lymphatic cancers, particularly non-Hodgkin Lymphoma, kidney damage and immune related rheumatoid [arthritis]. Studies show that HCV infection increases the risk of insulin resistance and diabetes by almost four times. Diabetes increases the risk of liver cancer in people living with HCV. . . .
Individuals who meet the standards set forth by the AASLD and IDSA, but who are excluded from receiving care, are put at a significant risk of many medical complications of HCV. HCV is known to have extrahepatic manifestations, described as effects on organ systems outside the liver. Without treatment, individuals may be needlessly exposed to depression, fatigue, sore mucles, joint pain, kidney injury, diabetes or glucose intolerance, certain types of rashes or autoimmune diseases. Without treatment, individuals with HCV are at increased risk of developing cirrhosis, liver cancer and liver failure requiring transplant. Furthermore, once individuals develop advanced liver disease they must undergo cancer screening at regular intervals for the rest of their life even after they are cured of their HCV.
(Trooskin Rpt., Pls.’ Ex. A, at 5.) Dr. Trooskin has also opined that delaying treatment of
individuals who have chronic HCV may result in “adverse effects including increasing the risk of
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death, causing irreversible liver damage, and needlessly prolonging suffering associated with the disease.” (Id. at 6.) Delaying treatment with DAAs “can cause damage to other vital organs” and “cause heart attacks, fatigue, joint pain, depression, sore muscles, arthritis, and, at times, premature death.” (Id. (citation omitted).)
Dr. Cowan testified at his deposition that the symptoms exhibited by individuals with chronic HCV may not be correlated to their Metavir scores. (Cowan Dep., DOC Defs.’ Ex. L, at 49-50.) Individuals with chronic HCV may suffer from extrahepatic and nonhepatic conditions such as mixed cryoglobulinemia, skin rash, kidney disease, and fatigue. (Id. at 50-51.) Moreover, individuals with Metavir scores of F1 may suffer from serious fatigue, anorexia, loss of appetite, headache, jaundice, and ascites (fluid in the abdomen). (Id. at 52-53.) Dr. Noel also testified that severe fatigue could be a symptom of HCV at any stage, including F1 and F2. (Noel Dep., DOC Defs.’ Ex. K, at 125, 142.) Dr. Kendig has also testified that “fatigue has been associated with Hepatitis C at all stages” and that patients can suffer from extrahepatic manifestations of chronic HCV when their Metavir scores are F0 and F1. (Kendig Dep., DOC Defs.’ Ex. R, at 39-40.)
Plaintiffs also argue that the DOC is deliberately indifferent to the serious medical needs of inmates with chronic HCV because it is prioritizing patients based on imprecise tests that may miss patients who may otherwise be entitled to treatment with DAAs under the Hepatitis C Protocol. As we discussed earlier, both Dr. Noel and Dr. Cowan acknowledge that APRI scores are only indirect markers of fibrosis and APRI scores at the 1.5 to 2 level only have “a sensitivity accuracy of about 48 percent.” (Cowan Dep. at 42; see also Noel Decl., DOC Defs.’ Ex. N, ¶ 23.) Consequently, using APRI scores could mean missing cirrhosis in half of inmates with APRI scores at the 1.5 to 2 level. (Cowan Dep. at 42.) In addition, an APRI score of 1 would miss approximately 23% of patients with cirrhosis. (Cowan Dep. at 42-43.)
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We conclude that the record contains evidence that patients who have chronic HCV and whose Metavir scores are less than F2 have serious medical needs, as they may suffer from fatigue and other nonhepatic symptoms of their infections and, if not treated with DAAs before their disease progresses, may suffer from liver inflammation, liver fibrosis, liver cancer and liver-related mortality that they would not suffer if they were treated with DAAs while their Metavir scores are in the F0 to F1 range. See Tsakonas, 308 F. App’x at 632. There is also evidence that the DOC’s reliance on an inaccurate method of testing for fibrosis could result in the DOC’s failing to treat many individuals who suffer from advanced fibrosis and cirrhosis. Based on all of the above, we further conclude that there is record evidence that raises a genuine issue of material fact regarding whether inmates who have chronic HCV but whose APRI scores do not yet correlate to Metavir scores of F3 and F4 have serious medical needs that the DOC Defendants are deliberately refusing to treat for non-medical reasons, such as cost. Accordingly, we deny the DOC Defendants’ Motion for Summary Judgment insofar as they argue that they are entitled to summary judgment on Count I because inmates who have been categorized as having Metavir scores of F0 to F1 do not have serious medical needs.
B. Count II The DOC Defendants argue that they are entitled to summary judgment on Count II, in which Plaintiffs seek injunctive relief for alleged violations of Article I, Section 13 of the Pennsylvania Constitution, because the Commonwealth has not waived its immunity as to this claim.7 The DOC Defendants rely on Pennsylvania’s sovereign immunity statute, which provides as follows:
7 Article I, § 13 of the Pennsylvania Constitution provides that “Excessive bail shall not be required, nor excessive fines imposed, nor cruel punishments inflicted.” Pa. Const. art. I, § 13.
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Pursuant to section 11 of Article 1 of the Constitution of Pennsylvania, it is hereby declared to be the intent of the General Assembly that the Commonwealth, and its officials and employees acting within the scope of their duties, shall continue to enjoy sovereign immunity and official immunity and remain immune from suit except as the General Assembly shall specifically waive the immunity. 1 Pa. Cons. Stat. Ann. § 2310. The General Assembly has specifically waived sovereign immunity in nine areas, which apply only to negligence suits for damages. See 42 Pa. Cons. Stat. Ann. § 8522. “[T]he General Assembly has not waived immunity for equitable claims seeking affirmative action by way of injunctive relief.” Collins v. State, No. 96 M.D. 2013, 2013 WL 5874770, at *3 (Pa. Commw. Ct. Oct. 31, 2013) (citing Bonsavage v. Borough of Warrior Run, 676 A.2d 1330, 1331 (Pa. Cmmw. Ct. 1996)). See also Bonsavage, 676 A.2d at 1331 (“[T]he General Assembly has waived sovereign immunity only for actions against Commonwealth parties ‘for damages arising out of a negligent act.’ Significantly, the General Assembly has not waived immunity for equitable claims seeking affirmative action by way of injunctive relief.”); Swift v. Dep’t of Transp., 937 A.2d 1162, 1168 (Pa. Commw. Ct. 2007) (“The General Assembly has not waived immunity for equitable claims seeking affirmative action by way of injunctive relief.” (citing Bonsavage, 676 A.2d 1330)); Cornish v. City of Phila., Civ. A. No. 14-6920, 2015 WL 3387052, at *9 (E.D. Pa. May 26, 2015) (dismissing medical care claim for injunctive relief brought against the DOC pursuant to Art. 1, § 13 of the Pennsylvania Constitution because the “DOC as a Commonwealth agency is entitled to sovereign immunity from [plaintiff’s] state constitutional claims for both equitable relief and damages”). We conclude that Pennsylvania has not waived its sovereign immunity with respect to Plaintiffs’ claim for injunctive relief for violation of Article I, Section 13 of the Pennsylvania Constitution and we grant the Motion for Summary Judgment as to Count II of the First Amended Complaint.
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C. Count III The DOC Defendants argue that they are entitled to summary judgment as to Chimenti’s medical malpractice claim in Count III of the First Amended Complaint because the evidence of record is not sufficient to establish a causal relationship between their alleged failure to conform to the appropriate standard of care and injury to Chimenti. To succeed on a medical malpractice claim, a plaintiff “is required to establish ‘that 1) the medical practitioner owed a duty to [him]; 2) the practitioner breached that duty; 3) the breach was the proximate cause of, or a substantial factor in, bringing about the harm [that he suffered]; and 4) the damages suffered were the direct result of the harm.’” Osborne v. Lewis, 59 A.3d 1109, 1114-15 (Pa. Super. Ct. 2012) (alterations in original) (quoting Carrozza v. Greenbaum, 866 A.2d 369, 379 (Pa. Super. Ct. 2004)). “‘When a party must prove causation through expert testimony the expert must testify with reasonable certainty that in his professional opinion, the result in question did come from the cause alleged.’” Reyes v. Otis Elevator Co., Civ. A. No. 13-4379, 2016 WL 6495115, at *4 (E.D. Pa. Nov. 2, 2016) (quoting Cohen v. Albert Einstein Med. Ctr., N. Div., 592 A.2d 720, 723 (Pa. Super. Ct. 1991)). Thus, “[u]nder Pennsylvania law, medical experts opining on causation must testify that defendant’s actions caused plaintiff’s condition with a reasonable degree of medical certainty.” McLeod v. Dollar Gen., Civ. A. No. 13-3113, 2014 WL 4634962, at *4 (E.D. Pa. Sept. 16, 2014) (citing In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 750 (3d Cir. 1994)). The Pennsylvania Superior Court has explained that “‘an expert fails this standard of certainty if he testifies that the alleged cause possibly, or could have[,] led to the result, that it could very properly account for the result, or even that it was very highly probable that it caused the result.’” Id. (alteration in original) (quoting Kravinsky v. Glover, 396 A.2d 1349, 1356 (Pa. Super. Ct. 1979)).
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Chimenti’s medical malpractice claim in Count III relies on the opinion of Dr. Bennet
Cecil, who has twenty years of experience in treating patients with HCV. (Pls.’ Ex. Q.) Dr. Cecil
has expressed the following opinions with “a reasonable degree of medical certainty.” (Id.)
Mr. Chimenti was treated with triple therapy but relapsed necessitating retreatment. A new treatment was available in October 2013 with Sovaldi but Mr. Chimenti was not allowed to have this new treatment. He should have taken Sovaldi, peginterferon and ribavirin at that time. Sovaldi plus Olysio combination therapy were also available but this was also denied. The Department of Corrections should have referred him to a hepatologist then but did not. They also refused to send him to a gastroenterologist. His medical practitioners were not qualified to treat him and his case reflects their errors.
Harvoni was FDA approved in October 2014 and again Mr. Chimenti was denied treatment. He had life threatening cirrhosis and denial of Harvoni represents deliberate indifference to his life. Lack of treatment injured him and increased his risk of death, liver cancer, worseing [sic] of liver failure and increased the need for a liver transplant in the future.
In 2015 a liver mass suspicious for liver cancer was found on a scan. The standard of care required referral to a liver cancer specialist and not a general oncologist. He was pressured into agreeing to a liver biopsy. No biopsy meant no treatment. This violated his human rights. The radiologist refused to do the biopsy. The liver lesion has not enlarged and is not considered a liver cancer at this time. There was no medical reason to delay Harvoni while waiting for a liver biopsy. That is not the standard of medical care.
Harvoni cured his HCV two years late and the delay irreparately [sic] worsened Mr. Chimenti. He has diabetes now likely related to his HCV. He has severe fatigue, memory problems related to hepatic encephalopathy.
The department of corrections ignored the clear national standards published by the American Association for the Study of Liver Diseases. They improperly mismanaged his life threatening medical condition instead of making a timely referrral [sic] to a hepatologist.
(Id.) We conclude that Dr. Cecil’s opinion satisfies the standard of certainty except with respect
to his statement that Chimenti’s diabetes is “likely related to his HCV” (id.), as this statement fails
to comply with the requisite standard of certainty for causation. See McLeod, 2014 WL 4634962,
at *4 (quotation omitted).
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The DOC Defendants also argue that they are entitled to summary judgment as to Chimenti’s medical malpractice claim because Dr. Cecil’s report does not specify what actions Dr. Noel took with respect to Chimenti’s medical care. The DOC Defendants, however, cite no authority for the proposition that a medical malpractice plaintiff must establish duty and breach of that duty solely through expert testimony and we are aware of none. Plaintiffs have submitted evidence that Dr. Noel was involved in the development of the DOC’s interim and final Hepatitis C Protocols and the decision of the DOC to cease all treatment for HCV before it developed a treatment protocol. (Noel Dep., DOC Defs.’ Ex K, at 31, 65-66, 68-70; Noel Decl., DOC Defs.’ Ex. N, ¶¶ 4-5.) There is also record evidence that Dr. Noel had the final authority to determine whether a particular inmate received DAA treatment, that medical staff consulted him regarding whether to provide DAA treatment to Chimenti, and that he was involved in the decision not to provide DAA treatment to Chimenti. (Noel Dep. at 154-56, 173, 176-78, 183-84, 187.) We conclude, accordingly, that there is sufficient evidence on the record to raise a genuine issue of material fact regarding whether Dr. Noel owed a duty to Chimenti; whether Dr. Noel breached that duty through his involvement in the decision to delay Chimenti’s treatment with DAAs; and whether that breach was a substantial factor in causing Chimenti to suffer severe fatigue, memory problems and increased risk of death, liver cancer, worsening of liver failure and an increased need for a liver transplant in the future. See Osborne, 59 A.3d at 1114-15 (quotation omitted). We therefore grant the DOC Defendants’ Motion for Summary Judgment as to Count III of the First Amended Complaint with respect to Dr. Cecil’s opinion that the DOC’s failure to treat Chimenti with DAAs in 2013 and 2014 was likely to have caused his diabetes and we deny the DOC’s Motion for Summary Judgment as to Count III of the First Amended Complaint in all other respects.
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IV. CONCLUSION For the reasons stated above, we grant the DOC Defendants’ Motion for Summary
Judgment as to the following: (1) Maldonado’s personal claim for injunctive relief pursuant to 42 U.S.C. § 1983 in Count I of the First Amended Complaint; (2) Plaintiffs’ claim for injunctive relief for violation of Article I, Section 13 of the Pennsylvania Constitution in Count II of the First Amended Complaint; and (3) that portion of Chimenti’s claim for medical malpractice in Count III of the First Amended Complaint that pertains to Dr. Cecil’s opinion that Chimenti’s diabetes is likely related to his HCV. The Motion for Summary Judgment is denied in all other respects. Accordingly, Plaintiffs may proceed with respect to their claims against the DOC Defendants for injunctive relief on behalf of Chimenti, Leyva, and the Class in Count I; Chimenti’s claim for monetary damages in Count I; and the remainder of Chimenti’s claim for medical malpractice in Count III. An appropriate Order follows.
BY THE COURT: /s/ John R. Padova ____________________________ John R. Padova, J.
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 Case 2:15-cv-03333-JP Document 125-2 Filed 11/19/18 Page 1 of 29
EXHIBIT 1

Case 2:15-cv-03333-JP Document 125-2 Filed 11/19/18 Page 2 of 29

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

SALVATORE CHIMENTI, et al., Plaintiff,
vs. PENNSYLVANIA DEPARTMENT OF CORRECTIONS, et al.
Defendants.

: : : : Civil No. 15-CV-3333 : : : Judge John R. Padova : :

SETTLEMENT AGREEMENT AND GENERAL RELEASE This SETTLEMENT AGREEMENT (“Settlement Agreement” or “Agreement”) sets forth the terms of the settlement by and between the individual and class Plaintiffs and Defendants Pennsylvania Department of Corrections (“DOC”), Secretary John Wetzel, and Dr. Paul Noel (collectively, the “DOC” defendants), on Plaintiffs’ claims for injunctive relief.
INTRODUCTION WHEREAS, Plaintiffs filed this lawsuit, on behalf of themselves and other similarly situated inmates who are in the custody of the DOC, alleging that the DOC, under its Hepatitis C Protocol and related practices, fails to provide necessary medical care to all inmates with Chronic Hepatitis C, in violation of the Eighth Amendment of the United States Constitution. WHEREAS, Plaintiffs and the DOC, without conceding any infirmity in their claims or defenses, have engaged in settlement negotiations to resolve the claims raised in this litigation and recognize that it is in their mutual best interest to fully resolve and finally settle any and all past, existing, and/or potential injunctive and equitable claims between the Plaintiffs and the DOC defendants relating to the Hepatitis C treatment.

Case 2:15-cv-03333-JP Document 125-2 Filed 11/19/18 Page 3 of 29 WHEREAS, the DOC is entering into this Settlement Agreement for the purpose
of settlement and nothing contained herein may be taken as or construed to be an admission or concession of any violation of law or regulation, or of any other matter of fact or law, or of any liability or wrongdoing (including allegations of the Amended Complaint), all of which the DOC expressly denies. The DOC does not admit to any violation of law and does not admit to any wrongdoing that was or could have been alleged by the Plaintiffs. No part of this Agreement, including its statements and commitments, shall constitute evidence of any liability, fault, or wrongdoing by the DOC or the DOC defendants.
WHEREAS, this Agreement is made without trial or adjudication of any issue of fact or law or finding of wrongdoing or liability of any kind. It is the intent of the parties that this Agreement shall not create a private cause of action or confer any right to any third party for violation of any federal or state statute. NOW, THEREFORE, IT IS HEREBY AGREED by and between the parties, as follows:
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DEFINITIONS As used in this Agreement, the following terms have the following meanings: 1. The “Hepatitis C Protocol” refers to the current 2018 DOC Hepatitis C Protocol,
and any superseding Protocol(s) promulgated by the DOC. See Exhibit A. 2. The “Preliminary Approval Date” is the date on which the U.S. District Court
gives preliminary approval to this Agreement. 3. The “Effective Date” means the date upon which the District Court gives final
approval to this Settlement Agreement. 4. “Class members” refers to all current and future inmates in the DOC with Chronic
Hepatitis C, but only for the duration of the Agreement. 5. “DAA” refers to the class of medications known as FDA-approved Direct-Acting
Antivirals used to treat Hepatitis C. 6. “Eligible Inmates” shall include all inmates with Chronic Hepatitis C who do not
affirmatively reject DAA treatment, have at least one year’s life expectancy, have a release date from the DOC at least twenty (20) weeks in the future, and for whom DAA treatment is not contraindicated under the terms of the Hepatitis C Protocol.
AGREEMENT In consideration of the mutual terms, covenants, conditions and releases of this Settlement Agreement, the parties agree as follows: 1. Replacement of the Hepatitis C Protocol No later than sixty (60) days after the Effective Date, the DOC shall replace the current Hepatitis C Protocol with a new Hepatitis C Protocol that incorporates and reflects the terms of
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this Settlement Agreement. The DOC shall be responsible for informing its staff, correctional
health care providers, and outside medical providers of the new Hepatitis C Protocol.
2. Medical Evaluation and Treatment for Identified Affected Inmates
Pursuant to this Settlement Agreement and the Hepatitis C Protocol, the DOC shall
provide DAA to inmates with Chronic Hepatitis C on the following schedule:
a. Upon the Preliminary Approval of this Agreement, all eligible inmates with a Metavir Fibrosis Score of F-2, F-3, or F-4, as determined by the testing standards set forth in the Hepatitis C Protocol, including consideration of APRI scores and Fibrosure tests, and named Plaintiff Daniel Leyva, shall be treated with DAA no later than six months following the DOC determination of their F-2, F-3 or F-4 Fibrosis Score, as more fully defined, para. 3, infra.
b. Starting July 1, 2019, and for each of the following two years to June 30, 2021, the DOC shall treat no fewer than 1500 eligible inmates each year with DAA, based on the priority provisions of the DOC Hepatitis C Protocol. For the year, July 1, 2021 to June 30, 2022, the DOC shall treat 2000 eligible inmates with DAA, based on the priority provisions of the DOC Hepatitis C Protocol. These requirements shall be suspended if and when the DAA treatments exhaust the entire pool of eligible inmates.
c. The DOC shall implement the priority treatment provisions of this Agreement and the DOC Hepatitis C Protocol based on the APRI and Fibrosure scores set forth in section 3, infra, and absent exigent circumstances, shall treat eligible inmates with the higher scores first, without regard to their release dates.
d. In the period from May 1 to July 1, 2022, the parties shall confer on a schedule for treating the eligible inmates not yet provided with DAA treatment, and to discuss termination of this Agreement. The parties agree that if the number of eligible inmates as of January 1, 2022 does not exceed 500, that none of these inmates have a Metavir Fibrosis Score of more than F-0, as defined in this Agreement, and that none of the eligible inmates have been awaiting DAA treatment for more than six months following documentation of their Chronic Hepatitis C status under the DOC Protocol, the Agreement shall be terminated as of June 30, 2022.
e. If these conditions are not satisfied, the parties shall negotiate a continuing treatment schedule and termination date. If the parties are unable to reach an Agreement, the Court, after hearing, may intervene to determine the schedule for DAA treatments going forward, and shall determine the termination date for the Agreement and for the Court’s jurisdiction over this case.
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3. Hepatitis C Metavir Fibrosis Score Testing
The DOC shall determine the Metavir Fibrosis Score referenced in this Settlement
Agreement and the Hepatitis C Protocol using the following tests:
a. Initially, the Fibrosis Score shall be determined by the APRI test score, with the following designations: APRI score of 2.0 or above, F-4; APRI score of more than 1.5-2.0, F-3; APRI score of more than 0.7-1.5, F-2; APRI score of more than 0.5-0.7, F-1; APRI score of less than 0.5, F-0; all subject to the provisions of 3(c) and (d).
b. Where Fibrosure is used to determine the Metavir Fibrosis Score (“Score”), the following designations shall be made: Less than 0.21, Score of F-0; 0.21-0.27, Score, F-0-F-1; 0.27-0.31, Score, F-1; 0.31-0.48, Score F-1-F-2; 0.48-0.58, Score F-2; 0.580.72, Score F-3; 0.72-0.74, Score F-3-F-4; greater than 0.74, Score F-4.
c. If the APRI and Fibrosure tests result in different Metavir Fibrosis Scores, the Fibrosure Score shall control.
d. Fibrosis Score evaluations of class members at F-0 to F-2 shall be made every six months, as set forth in the Hepatitis C Protocol.
4. Preventive Health and Patient Education
The class members shall be evaluated to assess the need for preventive health
interventions such as vaccines and screenings for other conditions, as well as counseled with
information on Hepatitis C infection. All inmates who are positive for the Hepatitis C virus shall
be evaluated to assess the need for the preventive health interventions in accordance with DOC
policies on preventive health visits, including:
● Hepatitis B vaccine: Indicated for susceptible class members with Chronic Hepatitis C infection. The DOC shall consider blood test prescreening for Hepatitis B immunity prior to vaccination.
● Class members with evidence of liver disease shall be priority candidates for a Hepatitis B vaccination.
● Hepatitis A vaccine: Indicated for susceptible class members with Chronic Hepatitis C infection. The DOC shall consider blood test prescreening for Hepatitis A immunity prior to vaccination.
● Influenza vaccine: Offer to all class members annually.
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● Class members with cirrhosis shall be high priority for an influenza vaccine.
Class members shall be counseled by a health care provider regarding the natural history of the infection, potential treatment options, and specific measures to prevent transmitting Hepatitis C infection to others (both during incarceration and upon release), consistent with DOC policies on preventive health visits and other policies. Class members have the right to refuse DAA treatment, but they shall be counseled by a health care provider regarding the risks of refusing treatment and the benefits of DAA treatment. These class members shall continue to be monitored under the terms of the Hepatitis C Protocol and may request DAA treatment at any time during the course or their incarceration. Upon such a request, the class member shall be provided DAA treatment under the terms of paras. 2 and 3, supra.
The DOC shall provide all class members who do not receive DAA treatment, before their release from custody, with pertinent information about their Hepatitis C condition and access to DAA treatment upon release through Medicaid or other state or local programs, including information provided by counsel for the Plaintiff Class.
5. Class Definition The definition of the class that was certified by the Court on May 24, 2018 shall be amended to include inmates with Chronic Hepatitis C who enter the DOC after the date of class certification. The class shall be defined as follows: All persons who are currently incarcerated in a Pennsylvania Department of Corrections (“DOC”) facility, or who are incarcerated in the DOC in the future, with a diagnosis of Chronic Hepatitis C, who have a release date from the DOC that is at least twenty (20) weeks in the future, who have a life expectancy of over one year, and for whom DAA treatment is not contraindicated under the terms of the Hepatitis C Protocol.
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The class shall be entitled to the benefits of this Agreement only for the duration of the Agreement.
6. Notice to Inmates The DOC shall provide notice to all class members of this Settlement Agreement
by:
 Making regular audio and video announcements at each DOC facility equipped with a CCTV system and/or prison-wide intercom system for a fourteen (14) day period beginning within thirty (30) days of the Effective Date;
 If a DOC facility has neither a prison-wide intercom nor a CCTV system, DOC shall provide each class member with a written version of the announcement;
 Posting a copy of this Agreement in each medical facility accessible to inmates for a period of at least two (2) years;
 Posting a copy of this Agreement in each library accessible to class members for the period of this Agreement; and
 Providing class members with a letter from Plaintiffs’ counsel explaining the Agreement and access to DAA treatment.
7. Monitoring Period For a period that begins with the Effective Date of this Agreement and ending with the termination of the Agreement, the DOC shall on a quarterly basis provide Plaintiffs’ counsel with reports to permit monitoring of the implementation of the Agreement. These reports shall include the data currently maintained on the DOC Hepatitis C Spreadsheets regarding testing, diagnosis, evaluation, and treatment of all class members diagnosed with Chronic Hepatitis C in the DOC, and the class members’ Metavir Fibrosis Scores by date determined, and scheduled dates for DAA treatment. The Spreadsheets, or other documentation, shall also include (a) information regarding all inmates with Chronic Hepatitis C who, because of any exclusionary policy or reason, is not being provided DAA; (b) the specific reason(s) for non-treatment with
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DAA; and (c) the dates of entry into and release from the DOC of eligible inmates not provided with DAA treatment during their incarceration.
8. Notice and Comment to Future Changes to the Hepatitis C Protocol During the period of this agreement (pre-termination), the DOC shall provide Plaintiffs’ counsel with a copy of any proposed revisions or changes to the Hepatitis C Protocol. Such proposed revisions or changes shall not be placed into effect without Plaintiffs’ counsel being given an opportunity to provide comments on the changes and, if invoked, until the conclusion of the Dispute Resolution procedure identified below. 9. Dispute Resolution If Plaintiffs’ counsel believe that the DOC has improperly denied a class member medically necessary DAA, failed to comply with the terms of this Settlement Agreement, or proposed revisions or changes to the Hepatitis C Protocol that are inconsistent with the Settlement Agreement, Plaintiffs’ counsel will provide the DOC with a notice of potential noncompliance. This notice will identify, with particularity, the basis of the claim that the DOC is not in compliance and the specific material provision of the Settlement Agreement or Hepatitis C Protocol that is implicated. Within thirty (30) days of receipt of the notification, the DOC shall provide a good-faith written response to the Plaintiffs’ notification with a full factual explanation as to why the DOC believes it is in compliance with the specified material provisions, or an explanation of the DOC’s plans to achieve full compliance with the specified material provisions. It is understood between the parties that certain unforeseeable events or conditions, for example, long-term lockdowns in the DOC, changes adopted by the AASLD/IDSA regarding medical treatment for persons with Chronic Hepatitis C, or changes in FDA regulations, may
8

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prevent compliance with this Agreement. If so, the DOC shall notify Plaintiffs’ counsel of the event or condition and the parties shall enter into good-faith discussions to resolve the issues.
If the parties are unable to resolve the dispute within thirty (30) days of DOC’s response, Plaintiffs’ counsel may seek intervention from the Court by filing a motion for specific performance of the material provision identified through the aforementioned Dispute Resolution procedure. The Court may order specific performance of the material provision upon a showing that the DOC is in substantial non-compliance with the material provision specified in the notice. The Court may not entertain a motion for contempt and the Court may not grant any remedial relief in the nature of a contempt of court finding against the Department. However, if the Department does not comply with an order for specific performance, the Court may order additional equitable relief, including extending the term of this Agreement in one (1) year increments. In no event, may the Court extend the term of this Agreement beyond five (5) years from the Effective Date of this Agreement.
10. Preliminary Approval As soon as practicable following execution of this Agreement, the parties shall apply to the Court for a preliminary order: a. Granting Preliminary Approval of this Agreement for purposes of disseminating
notice to current DOC prisoners who are Class Members; b. Approving the form, contents, and dissemination of the Notice of this Agreement
to current DOC prisoners who are Class Members; and c. Scheduling a Fairness Hearing to review comments and/or objections regarding
this Agreement, consider the fairness, reasonableness, and adequacy of this Agreement, and consider whether the Court should order Final Approval of this Agreement and grant Class Counsel’s requested Fee Award. 11. Final Approval This Agreement shall be subject to the Final Approval of the Court. The parties shall
9

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cooperate in presenting this Agreement to the Court for Final Approval and/or at any hearing under Rule 23(e) of the Federal Rules of Civil Procedure. If the Court does not grant Final Approval, this Agreement shall be null and void and of no force and effect, and nothing herein shall be deemed to prejudice the position of any party with respect to the Action or otherwise, and neither the existence of this Agreement, nor any of its terms or provisions, nor any of the negotiations or proceedings connected with it, shall be admissible in evidence, referred to for any purpose in the Action or in any other litigation or proceeding, or construed as an admission, presumption, or concession by any Defendant of any liability or the truth of any of the allegations in the Action.
12. Dismissal The parties understand and agree that the Court will maintain jurisdiction of this civil action throughout the duration of the Agreement to enforce the provisions of the Agreement and that the Plaintiffs may seek to enforce the Agreement, pursuant to paragraph 9, supra. The parties also agree that, upon termination of the Agreement, they will sign and submit a joint stipulation of dismissal with prejudice pursuant to F. R. Civ. P. 4l (a), thereby ending the Court’s jurisdiction over this case. 13. No Admission of Liability Neither this Settlement Agreement nor anything in this Settlement Agreement shall be deemed an admission or concession of liability or evidence respecting any liability on the part of the DOC Defendants or an admission that any of Plaintiffs’ claims lack merit. Neither this Agreement nor any policies or procedures referenced herein shall define any state or federal constitutional rights. 14. Notices
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All notices required under the Agreement will be sent overnight mail or overnight courier to the following:
To Plaintiffs: David Rudovsky Kairys, Rudovsky, Messing, Feinberg & Lin, LLP 718 Arch Street, Suite 501S Philadelphia, PA 19106 and Su Ming Yeh Pennsylvania Institutional Law Project The Cast Iron Building 718 Arch Street, Suite 304 South Philadelphia, PA 19106
To Defendants: Vincent R. Mazeski Department of Corrections Office of Chief Counsel 1920 Technology Parkway Mechanicsburg, PA 17050
Either party may substitute the individual designated to receive notice by advising the other side in a writing sent by overnight mail or overnight courier.
15. Payment of Attorneys’ Fees and Costs The DOC agrees to pay Plaintiffs’ attorneys $195,000 in Attorneys’ Fees and Costs within sixty (60) days of the Effective Date of this Agreement. Plaintiffs’ counsel agree to monitor the enforcement of this Agreement without payment of counsel fees; provided, however, that if the Plaintiffs prevail on a motion to enforce the Agreement pursuant to para. 9, supra, Plaintiffs’ counsel may seek attorneys’ fees and costs for reasonable time spent on the enforcement of this Agreement.
11

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16. Release In consideration of the terms and conditions called for herein, Plaintiffs release and completely and forever discharge the DOC, their agents, attorneys, servants, representatives, and employees, past and present, and their past, present, and future agents, attorneys, servants, representatives, and employees, and all other persons with whom any of the former have been, are now, or may hereinafter be affiliated, of and from any and all past or present claims, demands, obligations, actions, causes of action, rights, damages, costs, expenses, and any claims for relief or punitive or other damages of any type which have accrued as of the Effective Date of this Agreement, and which relate to the subject matter of this civil action. 17. Non-Waiver of Claims and Defenses as to Non-Parties The parties agree that by entering into this Settlement Agreement, Plaintiffs do not waive other rights to continue to pursue claims against any non-party to this Settlement Agreement. Furthermore, this Settlement Agreement does not waive any rights of other inmates in the custody of the DOC. 18. Integration Clause The terms of this Settlement Agreement and its exhibits as written are the entire agreement and there are no other terms relied upon by the parties, verbal or otherwise. 19. Counterparts This Settlement Agreement may be signed in multiple counterparts by fax or email and interchangeably executed. Such execution shall be valid and binding upon the parties and all counterparts when so executed and shall together be deemed one final original instrument. The parties may rely on fax or email copies as if they were originals and such copies shall be equally admissible in evidence.
12

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20. Captions The captions and headings used throughout this Settlement Agreement are for convenience only and shall not be deemed to modify the meaning of any provisions of this Settlement Agreement. 21. Written Modification As permitted by law, this Settlement Agreement may be modified only by a written instrument signed by both the parties. 22. Severability If, for any reason, any provision of this Settlement Agreement is determined to be invalid or unenforceable, the remaining provisions of this Settlement Agreement shall be construed, performed, or enforced as if the invalidated or unenforceable provision had not been included in the text of the Agreement. 23. Governing Laws This Settlement Agreement shall be governed by the laws of the Commonwealth of Pennsylvania. 24. Binding Effect Except as provided elsewhere herein, this Settlement Agreement is binding upon the parties and their respective agents, officers, directors, employees, executors, administrators, heirs, assigns, and successors-in-interest regarding this action. 25. Advice of Counsel The parties acknowledge that each has carefully read the entire Settlement Agreement, has been given the opportunity to consult with and be advised by their attorney, and knows and understands the contents of this Settlement Agreement.
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EXHIBIT A

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 Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 1 of 17
CLOSED,STANDARD
United States District Court Eastern District of Pennsylvania (Philadelphia) CIVIL DOCKET FOR CASE #: 2:15−cv−03333−JP

CHIMENTI et al v. PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC) et al Assigned to: HONORABLE JOHN R. PADOVA Referred to: MAGISTRATE JUDGE TIMOTHY R. RICE (Settlement) Cause: 42:1983 Civil Rights Act
Plaintiff

Date Filed: 06/12/2015 Date Terminated: 02/07/2019 Jury Demand: Defendant Nature of Suit: 550 Prisoner Petitions: Civil Rights Jurisdiction: Federal Question

SALVATORE CHIMENTI

represented by ANGUS R. LOVE PA INSTITUTIONAL LAW PROJECT 718 ARCH ST., STE 304S PHILADELPHIA, PA 19106 215−925−2966 Email: alove@pailp.org TERMINATED: 09/20/2018 LEAD ATTORNEY

DAVID RUDOVSKY KAIRYS RUDOVSKY MESSING FEINBERG & LIN, LLP THE CAST IRON BLDG STE 501 SOUTH 718 ARCH STREET PHILADELPHIA, PA 19106 215−925−4400 Fax: 215−925−5365 Email: drudovsky@krlawphila.com TERMINATED: 09/20/2018 LEAD ATTORNEY

STEPHEN D. BROWN DECHERT LLP 2929 ARCH STREET PHILADELPHIA, PA 19104 TEL 215−994−2240 Fax: FAX 215−655−2240 Email: stephen.brown@dechert.com TERMINATED: 09/20/2018 LEAD ATTORNEY

SU MING YEH PA Institutional Law Project 718 Arch Street, Suite 304S Philadelphia, PA 19106 215−925−2966 Fax: 215−925−5337 Email: smyeh@pailp.org TERMINATED: 09/20/2018 LEAD ATTORNEY

CHRISTINE C. LEVIN DECHERT LLP CIRA CENTRE 2929 ARCH ST PHILADELPHIA, PA 19104 215−994−4000 Email: christine.levin@dechert.com TERMINATED: 09/20/2018

Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 2 of 17

Plaintiff DANIEL LEYVA
Plaintiff DAVID MALDONADO AND ALL OTHERS SIMILARLY SITUATED

ETHAN SOLOVE STRUCTURE LAW GROUP, LLP 1754 TECHNOLOGY DRIVE SUITE 135 SAN JOSE, CA 95110 408−809−1244 Email: esolove@structurelaw.com TERMINATED: 09/20/2018
ROSE MARIE WONG DECHERT LLP 2929 ARCH ST PHILADELPHIA, PA 19104 215−994−2052 Email: rosey.wong@dechert.com TERMINATED: 09/20/2018
represented by ANGUS R. LOVE (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
DAVID RUDOVSKY (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
STEPHEN D. BROWN (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
SU MING YEH (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
CHRISTINE C. LEVIN (See above for address) ATTORNEY TO BE NOTICED
ETHAN SOLOVE (See above for address) ATTORNEY TO BE NOTICED
ROSE MARIE WONG (See above for address) ATTORNEY TO BE NOTICED
represented by ANGUS R. LOVE (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
DAVID RUDOVSKY (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
STEPHEN D. BROWN (See above for address)

Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 3 of 17
LEAD ATTORNEY ATTORNEY TO BE NOTICED
SU MING YEH (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
CHRISTINE C. LEVIN (See above for address) ATTORNEY TO BE NOTICED
ETHAN SOLOVE (See above for address) ATTORNEY TO BE NOTICED
ROSE MARIE WONG (See above for address) ATTORNEY TO BE NOTICED

V. Defendant PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC) TERMINATED: 08/08/2017
Defendant JOHN WETZEL SECRETARY OF THE (DOC)
Defendant PAUL NOEL CHIEF MEDICAL DIRECTOR, PENNSYLVANIA DOC
Defendant CHRISTOPHER OPPMAN DIRECTOR, BUREAU OF HEALTH CARE SERVICES, DOC TERMINATED: 02/03/2017
Defendant KEPHART DR., MEDICAL DIRECTOR AT SCI SMITHFIELD, DOC TERMINATED: 02/03/2017

represented by VINCENT R. MAZESKI CHIEF COUNSEL'S OFFICE PENNSYLVANIA DEPT OF CORRECTIONS 1920 TECHNOLOGY PARKWAY MECHANICSBURG, PA 17050 717−728−7763 Fax: 717−728−0307 Email: vmazeski@pa.gov TERMINATED: 08/08/2017
represented by VINCENT R. MAZESKI (See above for address) ATTORNEY TO BE NOTICED
represented by VINCENT R. MAZESKI (See above for address) ATTORNEY TO BE NOTICED
represented by VINCENT R. MAZESKI (See above for address) TERMINATED: 02/03/2017
represented by CAITLIN J. GOODRICH WEBER GALLAGHER 2000 MARKET STREET 13TH FLOOR PHILADELPHIA, PA 19103 267−295−3367 Email: cgoodrich@wglaw.com TERMINATED: 02/03/2017
NOAH EVAN KATZ

Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 4 of 17

WEBER GALLAGHER 201 PENN AVE SUITE 400 SCRANTON, PA 18503 570−961−2099 Email: nkatz@wglaw.com TERMINATED: 02/03/2017

SAMUEL H. FOREMAN WEBER GALLAGHER SIMPSON STAPLETON FIRES & NEWBY, LLP TWO GATEWAY CENTER STE 1450 603 STANWIX STREET PITTSBURGH, PA 15222 412−281−4541 Email: sforeman@wglaw.com TERMINATED: 02/03/2017

Defendant
WILLIAM DREIBELBIS CORRECTIONAL HEALTH CARE ADMINISTRATOR, SCI SMITHFIELD, DOC TERMINATED: 02/03/2017

represented by VINCENT R. MAZESKI (See above for address) TERMINATED: 02/03/2017

Defendant
WEINER DR., MEDICAL DIRECTOR, SCI GRATERFORD TERMINATED: 02/03/2017

represented by CAITLIN J. GOODRICH (See above for address) TERMINATED: 02/03/2017
NOAH EVAN KATZ (See above for address) TERMINATED: 02/03/2017

SAMUEL H. FOREMAN (See above for address) TERMINATED: 02/03/2017

Defendant
JOSEPH C. KORSZNIAK CORRECTIONAL HEALTH CARE ADMINISTRATOR, SCI GRATERFORD TERMINATED: 02/03/2017

represented by VINCENT R. MAZESKI (See above for address) TERMINATED: 02/03/2017

Defendant
CORRECT CARE SOLUTIONS (CCS) TERMINATED: 08/30/2018

represented by CAITLIN J. GOODRICH (See above for address) TERMINATED: 08/30/2018

NOAH EVAN KATZ (See above for address) TERMINATED: 08/30/2018

SAMUEL H. FOREMAN (See above for address) TERMINATED: 08/30/2018

Defendant
NICHOLAS SCHARFF DR., MEDICAL DIRECTOR, CCS TERMINATED: 02/03/2017

represented by CAITLIN J. GOODRICH (See above for address) TERMINATED: 02/03/2017

NOAH EVAN KATZ

Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 5 of 17

(See above for address) TERMINATED: 02/03/2017

SAMUEL H. FOREMAN (See above for address) TERMINATED: 02/03/2017

Defendant
ANDREW DANCHA REGIONAL MEDICAL DIRECTOR, CCS TERMINATED: 02/03/2017

represented by CAITLIN J. GOODRICH (See above for address) TERMINATED: 02/03/2017

NOAH EVAN KATZ (See above for address) TERMINATED: 02/03/2017

SAMUEL H. FOREMAN (See above for address) TERMINATED: 02/03/2017

Defendant
JOHN HOCHBERG DR., ASSISTANT MEDICAL DIRECTOR, CCS TERMINATED: 02/03/2017

represented by CAITLIN J. GOODRICH (See above for address) TERMINATED: 02/03/2017
NOAH EVAN KATZ (See above for address) TERMINATED: 02/03/2017

SAMUEL H. FOREMAN (See above for address) TERMINATED: 02/03/2017

Defendant
WEXFORD HEALTH SOURCES, INC. TERMINATED: 08/30/2018

represented by CAITLIN J. GOODRICH (See above for address) TERMINATED: 08/30/2018

NOAH EVAN KATZ (See above for address) TERMINATED: 08/30/2018

SAMUEL H. FOREMAN (See above for address) TERMINATED: 08/30/2018

Defendant
THOMAS LEHMAN DR., MEDICAL DIRECTOR, WEXFORD HEALTH SOURCES, INC. TERMINATED: 02/03/2017

represented by CAITLIN J. GOODRICH (See above for address) TERMINATED: 02/03/2017
NOAH EVAN KATZ (See above for address) TERMINATED: 02/03/2017

SAMUEL H. FOREMAN (See above for address) TERMINATED: 02/03/2017

Defendant
DR. JAY COWAN MEDICAL DIRECTOR, CORRECT

represented by CAITLIN J. GOODRICH (See above for address)

Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 6 of 17

CARE SOLUTIONS. TERMINATED: 07/23/2018

TERMINATED: 07/23/2018
SAMUEL H. FOREMAN (See above for address) TERMINATED: 07/23/2018

Defendant
DR. JOHN KEPHART MEDICAL DIRECTOR (FORMER), SCI SMITHFIELD TERMINATED: 07/23/2018

represented by CAITLIN J. GOODRICH (See above for address) TERMINATED: 07/23/2018
NOAH EVAN KATZ (See above for address) TERMINATED: 07/23/2018

SAMUEL H. FOREMAN (See above for address) TERMINATED: 07/23/2018

Defendant
DR. JAMES FROMMER MEDICAL DIRECTOR, SCI SMITHFIELD TERMINATED: 07/23/2018

represented by CAITLIN J. GOODRICH (See above for address) TERMINATED: 07/23/2018
SAMUEL H. FOREMAN (See above for address) TERMINATED: 07/23/2018

Defendant
RICH WENHOLD INFECTION CONTROL COORDINATOR, PENNSYLVANIA DEPARTMENT OF CORRECTIONS TERMINATED: 08/08/2017

represented by VINCENT R. MAZESKI (See above for address) TERMINATED: 08/08/2017

Date Filed 06/12/2015 06/12/2015
06/12/2015 07/14/2015
07/15/2015

# Docket Text
1 COMPLAINT against All Defendants ( Filing fee $ 400 receipt number 122748.), filed by DAVID MALDONADO, SALVATORE CHIMENTI, DANIEL LEYVA. (Attachments: # 1 Civil Cover Sheets, # 2 Signature Page (Complaint))(tj, ) (Entered: 06/15/2015)
Summons Issued as to CORRECT CARE SOLUTIONS (CCS), ANDREW DANCHA, WILLIAM DREIBELBIS, JOHN HOCHBERG, KEPHART, JOSEPH C. KORSZNIAK, THOMAS LEHMAN, PAUL NOEL, CHRISTOPHER OPPMAN, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), NICHOLAS SCHARFF, WEINER, JOHN WETZEL, WEXFORD HEALTH SOURCES, INC.. Forwarded To: Counsel (Angus Love) on 6/15/15 (tj, ) (Entered: 06/15/2015)
2 MOTION FOR CLASS CERTIFICATION, filed by SALVATORE CHIMENTI, DANIEL LEYVA, DAVID MALDONADO,MEMORANDUM. (Attachments: # 1 Signature Page (Motion))(tj, ) (Entered: 06/15/2015)
3 NOTICE of Appearance by SAMUEL H. FOREMAN on behalf of CORRECT CARE SOLUTIONS (CCS), ANDREW DANCHA, JOHN HOCHBERG, KEPHART, THOMAS LEHMAN, NICHOLAS SCHARFF, WEINER, WEXFORD HEALTH SOURCES, INC. with Certificate of Service(FOREMAN, SAMUEL) (Entered: 07/14/2015)
4 NOTICE of Appearance by CAITLIN J. GOODRICH on behalf of CORRECT CARE SOLUTIONS (CCS), ANDREW DANCHA, JOHN HOCHBERG, KEPHART, THOMAS LEHMAN, NICHOLAS SCHARFF, WEINER, WEXFORD HEALTH SOURCES, INC. with Certificate of Service(GOODRICH, CAITLIN) (Entered:

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07/17/2015 07/17/2015 07/17/2015
07/17/2015 07/17/2015 08/11/2015 08/17/2015 08/17/2015 08/18/2015 08/18/2015 08/18/2015 08/24/2015

07/15/2015)
5 NOTICE of Appearance by VINCENT R. MAZESKI on behalf of WILLIAM DREIBELBIS, JOSEPH C. KORSZNIAK, PAUL NOEL, CHRISTOPHER OPPMAN, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), JOHN WETZEL with Certificate of Service(MAZESKI, VINCENT) (Entered: 07/17/2015)
6 DEMAND for Trial by Jury by WILLIAM DREIBELBIS, JOSEPH C. KORSZNIAK, PAUL NOEL, CHRISTOPHER OPPMAN, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), JOHN WETZEL. (MAZESKI, VINCENT) (Entered: 07/17/2015)
7 WAIVER OF SERVICE Returned Executed by SALVATORE CHIMENTI. WILLIAM DREIBELBIS waiver sent on 6/19/2015, answer due 8/18/2015; JOSEPH C. KORSZNIAK waiver sent on 6/19/2015, answer due 8/18/2015; PAUL NOEL waiver sent on 6/19/2015, answer due 8/18/2015; CHRISTOPHER OPPMAN waiver sent on 6/19/2015, answer due 8/18/2015; PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC) waiver sent on 6/19/2015, answer due 8/18/2015; JOHN WETZEL waiver sent on 6/19/2015, answer due 8/18/2015. (YEH, SU MING) (Entered: 07/17/2015)
8 WAIVER OF SERVICE Returned Executed by SALVATORE CHIMENTI. THOMAS LEHMAN waiver sent on 6/19/2015, answer due 8/18/2015. (YEH, SU MING) (Entered: 07/17/2015)
9 WAIVER OF SERVICE Returned Executed by SALVATORE CHIMENTI. WEXFORD HEALTH SOURCES, INC. waiver sent on 6/19/2015, answer due 8/18/2015. (YEH, SU MING) (Entered: 07/17/2015)
10 Certificate of Merit by SU MING YEH on behalf of SALVATORE CHIMENTI(YEH, SU MING) Modified on 8/13/2015 (tjd). (Entered: 08/11/2015)
11 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by WILLIAM DREIBELBIS, JOSEPH C. KORSZNIAK, PAUL NOEL, CHRISTOPHER OPPMAN, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), JOHN WETZEL.Certificate of Service. (Attachments: # 1 Text of Proposed Order)(MAZESKI, VINCENT) (Entered: 08/17/2015)
12 Memorandum in Support re 11 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by WILLIAM DREIBELBIS, JOSEPH C. KORSZNIAK, PAUL NOEL, CHRISTOPHER OPPMAN, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), JOHN WETZEL. (MAZESKI, VINCENT) (Entered: 08/17/2015)
13 RESPONSE in Opposition re 2 MOTION to Certify Class filed by WILLIAM DREIBELBIS, JOSEPH C. KORSZNIAK, PAUL NOEL, CHRISTOPHER OPPMAN, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), JOHN WETZEL. (Attachments: # 1 Text of Proposed Order)(MAZESKI, VINCENT) (Entered: 08/18/2015)
14 MOTION to Dismiss , MOTION to Sever filed by CORRECT CARE SOLUTIONS (CCS), ANDREW DANCHA, JOHN HOCHBERG, KEPHART, THOMAS LEHMAN, NICHOLAS SCHARFF, WEINER, WEXFORD HEALTH SOURCES, INC..Certificate of Service. (Attachments: # 1 Text of Proposed Order)(FOREMAN, SAMUEL) (Entered: 08/18/2015)
15 Brief in Support re 14 MOTION to Dismiss MOTION to Sever filed by CORRECT CARE SOLUTIONS (CCS), ANDREW DANCHA, JOHN HOCHBERG, KEPHART, THOMAS LEHMAN, NICHOLAS SCHARFF, WEINER, WEXFORD HEALTH SOURCES, INC. Certificate of Service. (FOREMAN, SAMUEL) Modified on 8/19/2015 (tjd). (Entered: 08/18/2015)
16 FILED IN ERROR, ATTORNEY TO REFILE (NOTICE of Appearance by ETHAN SOLOVE on behalf of SALVATORE CHIMENTI, DANIEL LEYVA, DAVID MALDONADO with Certificate of Service(SOLOVE, ETHAN) Modified on 8/31/2015 (kp, ). (Entered: 08/24/2015)

Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 8 of 17

08/24/2015 08/28/2015 08/28/2015 08/31/2015 08/31/2015
08/31/2015
09/11/2015 03/07/2016 03/14/2016 03/21/2016 03/21/2016
04/01/2016

17 NOTICE of Appearance by ETHAN SOLOVE on behalf of SALVATORE CHIMENTI, DANIEL LEYVA, DAVID MALDONADO with Certificate of Service(SOLOVE, ETHAN) (Entered: 08/24/2015)
18 STIPULATION re 13 Response in Opposition to Motion, by SALVATORE CHIMENTI. (YEH, SU MING) (Entered: 08/28/2015)
19 MOTION for Extension of Time to File Response/Reply to Ds Motions to Dismiss and Motion to Sever filed by SALVATORE CHIMENTI.Certificate of Service. (Attachments: # 1 Text of Proposed Order)(YEH, SU MING) (Entered: 08/28/2015)
20 NOTICE of Appearance by CHRISTINE C. LEVIN on behalf of SALVATORE CHIMENTI, DANIEL LEYVA, DAVID MALDONADO with Certificate of Service(LEVIN, CHRISTINE) (Entered: 08/31/2015)
21 STIPULATION AND ORDER THAT DOC DEFENDANTS WITHDRAW THEIR BRIEF IN OPPOSITION TO MOTION FOR CLASS CERTIFICATION (DOC. NO. 13), WITHOUT PREJUDICE TO REFILE. ALL DEFENDANTS MAY FILE RESPONSES TO PLAINTIFFS' MOTION FOR CLASS CERTIFICATION PURSUANT TO DATES SET BY FUTURE STIPULATION BY THE PARTIES, IF STILL APPROPRIATE, AFTER THE ISSUE OF VENUE HAS BEEN DECIDED BY THE COURT, OR PURSUANT TO ANY SCHEDULING OR CASE MANAGEMENT ORDER ISSUED BY THE COURT. THIS STIPULATION AND ORDER IS WITHOUT PREJUDICE TO ANY RIGHTS OR DEFENSES THAT DEFENDANTS MAY HAVE. SIGNED BY HONORABLE JOHN R. PADOVA ON 8/31/2015. 9/1/2015 ENTERED AND COPIES E−MAILED. (ems) (Entered: 09/01/2015)
22 ORDER THAT PLAINTIFFS' MOTION FOR EXTENSTION OF TIME TO RESPOND TO DEFENDANTS' MOTIONS TO DISMISS AND MOTION TO SEVER IS GRANTED. PLAINTIFFS SHALL FILE THEIR RESPONSE(S) ON OR BEFORE 9/11/2015. SIGNED BY HONORABLE JOHN R. PADOVA ON 8/31/2015. 9/1/2015 ENTERED AND COPIES E−MAILED. (ems) (Entered: 09/01/2015)
23 RESPONSE in Opposition re 14 MOTION to Dismiss MOTION to Sever , 11 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by SALVATORE CHIMENTI, DANIEL LEYVA, and DAVID MALDONADO. (Attachments: # 1 Text of Proposed Order, # 2 Exhibit)(YEH, SU MING) Modified on 9/14/2015 (tjd). (Entered: 09/11/2015)
24 ORDER THAT PLAINTIFFS' MOTION FOR CLASS CERTIFICATION IS STAYED, PENDING THE RESOLUTION OF DEFENDANTS' MOTION TO DISMISS. SIGNED BY HONORABLE JOHN R. PADOVA ON 3/7/16. 3/8/16 ENTERED AND COPIES EMAILED TO COUNSEL.(jaa, ) (Entered: 03/08/2016)
25 NOTICE of Appearance by NOAH EVAN KATZ on behalf of CORRECT CARE SOLUTIONS (CCS), ANDREW DANCHA, JOHN HOCHBERG, KEPHART, THOMAS LEHMAN, NICHOLAS SCHARFF, WEINER, WEXFORD HEALTH SOURCES, INC. with Certificate of Service(KATZ, NOAH) (Entered: 03/14/2016)
26 MEMORANDUM AND/OR OPINION. SIGNED BY HONORABLE JOHN R. PADOVA ON 3/21/16. 3/22/16 ENTERED AND COPIES E−MAILED.(gs) (Entered: 03/22/2016)
27 ORDER THAT UPON CONSIDERATION OF THE DOC DEFENDANTS' MOTION TO DISMISS 11 AND THE MOTION TO DISMISS AND SEVER 14 , IT IS ORDERED THE MOTION TO DISMISS IS GRANTED IN PART AND DENIED IN PART. THE MOTION TO DISMISS AND SEVER IS GRANTED IN PART AND DENIED IN PART AS OUTLINED HEREIN. SIGNED BY HONORABLE JOHN R. PADOVA ON 3/21/16. 3/22/16 ENTERED AND COPIES E−MAILED.(gs) (Entered: 03/22/2016)
28 MOTION for Extension of Time to File Answer filed by WILLIAM DREIBELBIS, JOSEPH C. KORSZNIAK, PAUL NOEL, CHRISTOPHER OPPMAN, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), JOHN WETZEL.. (Attachments: # 1 Text of Proposed Order)(MAZESKI, VINCENT) (Entered: 04/01/2016)

Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 9 of 17

04/04/2016
04/04/2016 05/04/2016 05/04/2016 05/04/2016 05/05/2016 05/05/2016 05/05/2016
05/18/2016 05/24/2016
05/25/2016 05/25/2016

29 ORDER THAT DEFENDANTS' MOTION FOR ENLARGEMENT OF TIME IS GRANTED. DEFENDANTS SHALL FILE AN ANSWER TO THE COMPLAINT AND AN ANSWER TO THE MOTION FOR CLASS CERTIFICATION ON OR BEFORE 5/5/2016.. SIGNED BY HONORABLE JOHN R. PADOVA ON 4/4/2016.4/4/2016 ENTERED AND COPIES E−MAILED.(kp, ) (Entered: 04/04/2016)
Set/Reset Deadlines as to RESPONSES DUE BY 5/5/2016. (kp, ) (Entered: 04/04/2016)
30 ANSWER to 1 Complaint by WILLIAM DREIBELBIS, JOSEPH C. KORSZNIAK, PAUL NOEL, CHRISTOPHER OPPMAN, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), JOHN WETZEL. Affirmative Defenses, Certificate of Service.(MAZESKI, VINCENT) Modified on 5/5/2016 (tjd). (Entered: 05/04/2016)
31 RESPONSE to Motion re 2 MOTION to Certify Class filed by WILLIAM DREIBELBIS, JOSEPH C. KORSZNIAK, PAUL NOEL, CHRISTOPHER OPPMAN, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), JOHN WETZEL. Certificate of Service. (Attachments: # 1 Text of Proposed Order)(MAZESKI, VINCENT) Modified on 5/5/2016 (tjd). (Entered: 05/04/2016)
32 Brief in Opposition re 2 MOTION to Certify Class filed by WILLIAM DREIBELBIS, JOSEPH C. KORSZNIAK, PAUL NOEL, CHRISTOPHER OPPMAN, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), JOHN WETZEL. Certificate of Service. (Attachments: # 1 Exhibit, # 2 Exhibit)(MAZESKI, VINCENT) Modified on 5/5/2016 (tjd). (Entered: 05/04/2016)
33 NOTICE of Hearing: A PRELIMINARY PRETRIAL CONFERENCE IS SET FOR 5/24/2016 AT 10:30 AM IN JUDGE CHAMBERS BEFORE HONORABLE JOHN R. PADOVA. (Attachments: # 1 Case Management Track Form, # 2 Case Management Track Form)(cl, ) (Entered: 05/05/2016)
34 ANSWER to 1 Complaint by CORRECT CARE SOLUTIONS (CCS), ANDREW DANCHA, JOHN HOCHBERG, KEPHART, THOMAS LEHMAN, NICHOLAS SCHARFF, WEINER, WEXFORD HEALTH SOURCES, INC. Affirmative Defenses, Certificate of Service.(GOODRICH, CAITLIN) Modified on 5/6/2016 (tjd). (Entered: 05/05/2016)
35 Brief in Opposition re 2 MOTION to Certify Class filed by CORRECT CARE SOLUTIONS (CCS), ANDREW DANCHA, JOHN HOCHBERG, KEPHART, THOMAS LEHMAN, NICHOLAS SCHARFF, WEINER, WEXFORD HEALTH SOURCES, INC. Certificate of Service. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E)(GOODRICH, CAITLIN) Modified on 5/6/2016 (tjd). (Entered: 05/05/2016)
36 MOTION for Extension of Time to File Response/Reply as to 35 Response in Opposition to Motion, 32 Memorandum, filed by SALVATORE CHIMENTI.Certificate of Service. (Attachments: # 1 Text of Proposed Order)(YEH, SU MING) (Entered: 05/18/2016)
37 ORDER THAT UPON CONSIDERATION OF "PLAINTIFFS' MOTION FOR EXTENSION OF TIME TO REPLY TO MOTION FOR CLASS CERTIFICATION" 36 , IT IS ORDERED THE MOTION IS GRANTED. PLAINTIFFS MAY FILE A REPLY IN SUPPORT OF THEIR MOTION NO LATER THAN 1/9/2017. SIGNED BY HONORABLE JOHN R. PADOVA ON 5/24/16. 5/24/16 ENTERED AND COPIES E−MAILED.(gs) (Entered: 05/24/2016)
38 Minute Entry for proceedings held before HONORABLE JOHN R. PADOVA Preliminary Pretrial Conference held on 5/24/2016 (kp, ) (Entered: 05/25/2016)
39 SCHEDULING ORDER THAT A FINAL PRETRIAL CONFERENCE IS SET FOR 2/27/2017 AT 10:30 AM IN JUDGES CHAMBERS BEFORE HONORABLE JOHN R. PADOVA. ALL DISCOVERY DUE BY 11/28/2016. DISPOSITIVE MOTIONS DUE BY 12/12/2016. MOTIONS IN LIMINE DUE BY 2/15/2017. PLAINTIFF PRETRIAL MEMO DUE BY 2/1/2017. DEFENDANT PRETRIAL MEMO DUE BY 2/15/2017. TRIAL POOL SET FOR 3/1/2017. FURTHER INSTRUCTIONS AND DEADLINES AS OUTLINED HEREIN.. SIGNED BY HONORABLE JOHN R. PADOVA ON 5/24/2016. 5/25/2016 ENTERED AND COPIES E−MAILED.(kp, )

Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 10 of 17

10/24/2016 10/27/2016 11/07/2016 11/07/2016 11/07/2016
11/08/2016 11/14/2016 11/15/2016
02/01/2017 02/03/2017
02/03/2017
02/03/2017 02/03/2017

Modified on 11/7/2016 (jaa, ). *VACATED PER ORDER 11/7/16. (Entered: 05/25/2016)
40 NOTICE of Hearing:A TELEPHONE CONFERENCE IS SET FOR 11/2/2016 AT 02:00 PM BEFORE HONORABLE JOHN R. PADOVA.(cl, ) (Entered: 10/24/2016)
41 NOTICE of Hearing:A TELEPHONE CONFERENCE IS SET FOR 11/7/2016 AT 11:30 AM BEFORE HONORABLE JOHN R. PADOVA.(cl, ) (Entered: 10/27/2016)
42 NOTICE of Appearance by ROSE MARIE WONG on behalf of SALVATORE CHIMENTI, DANIEL LEYVA, DAVID MALDONADO with Certificate of Service(WONG, ROSE MARIE) (Entered: 11/07/2016)
43 ORDER THAT THE SCHEDULING ORDER DATED MAY 25, 2016 IS VACATED. SIGNED BY HONORABLE JOHN R. PADOVA ON 11/7/16. 11/7/16 ENTERED AND COPIES EMAILED TO COUNSEL.(jaa, ) (Entered: 11/07/2016)
44 ORDER THAT THE PARTIES' REQUEST FOR AN EXTENSION OF DISCOVERY IS GRANTED AND FURTHER ORDERED THAT AMENDED PLEADINGS DUE BY 2/1/2017. DISCOVERY DUE BY 5/15/2017. MOTIONS DUE BY 7/1/2017. SIGNED BY HONORABLE JOHN R. PADOVA ON 11/7/16. 11/7/16 ENTERED AND COPIES EMAILED TO COUNSEL.(jaa, ) (Entered: 11/07/2016)
45 Minute Entry for proceedings held before HONORABLE JOHN R. PADOVA Telephone Conference held on 11/7/2016 (kp, ) (Entered: 11/08/2016)
46 Proposed − Stipulated Protective Order filed by SALVATORE CHIMENTI. Certificate or Service. (Attachments: # 1 Certificate of Service)(YEH, SU MING) Modified on 11/16/2016 (tjd). (Entered: 11/14/2016)
47 STIPULATED PROTECTIVE ORDER PROHIBITS THAT THE PARTIES FROM USING OR DISCLOSING THE PROTECTED HEALTH INFORMATION FOR ANY PURPOSE OTHER THAN THE LITIGATION OR PROCEEDING FOR WHICH SUCH INFORMATION WAS REQUESTED, AND DISTRIBUTION OF THE DOCUMENTS ARE LIMITED TO ONLY THOSE PERSONS WHO NEED TO HANDLE OR READ THE DOCUMENTS IN THE INSTANT LAWSUIT; AND REQUIRES THE RETURN TO THE COVERED ENTITY OR DESTRUCTION OF THE PROTECTED HEALTH INFORMATION (INCLUDING ALL COPIES MADE) AT THE END OF THE LITIGATION OR PROCEEDING.. SIGNED BY HONORABLE JOHN R. PADOVA ON 11/15/16. 11/15/16 ENTERED AND COPIES E−MAILED TO COUNSEL.(pr, ) (Entered: 11/15/2016)
48 MOTION for Leave to File Amended Complaint filed by SALVATORE CHIMENTI.Certificate of Service. (Attachments: # 1 Text of Proposed Order, # 2 Exhibit First Amended Complaint)(YEH, SU MING) (Entered: 02/01/2017)
49 ORDER THAT PLAINTIFFS' 48 MOTION FOR LEAVE TO FILE AN AMENDED COMPLAINT IS GRANTED. THE CLERK SHALL DOCKET THE AMENDED COMPLAINT, ATTACHED TO THE MOTION AS AN EXHIBIT. SIGNED BY HONORABLE JOHN R. PADOVA ON 2/2/2017. 2/3/2017 ENTERED AND COPIES E−MAILED.(kp, ) (Entered: 02/03/2017)
50 FIRST AMENDED COMPLAINT against CORRECT CARE SOLUTIONS (CCS), PAUL NOEL, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), JOHN WETZEL, WEXFORD HEALTH SOURCES, INC., JAY COWAN, JOHN KEPHART, JAMES FROMMER, RICH WENHOLD, filed by DAVID MALDONADO, SALVATORE CHIMENTI, DANIEL LEYVA.(kp, ) (Entered: 02/03/2017)
3 Summons Issued as to JAY COWAN, JAMES FROMMER, RICH WENHOLD. Forwarded To: D. Rudovsky on 2/3/2017 (kp, ) (Entered: 02/03/2017)
51 NOTICE of Appearance by CAITLIN J. GOODRICH on behalf of JAY COWAN, JAMES FROMMER with Certificate of SErvice(GOODRICH, CAITLIN) (Entered: 02/03/2017)

Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 11 of 17

02/03/2017 02/06/2017 02/06/2017 02/06/2017 02/08/2017 02/08/2017 02/08/2017 02/08/2017 02/08/2017
02/08/2017 02/17/2017
02/21/2017 02/21/2017 02/21/2017
02/22/2017

52 NOTICE of Appearance by SAMUEL H. FOREMAN on behalf of JAY COWAN, JAMES FROMMER with Certificate of Service(FOREMAN, SAMUEL) (Entered: 02/03/2017)
53 WAIVER OF SERVICE Returned Executed by RICH WENHOLD. RICH WENHOLD waiver sent on 2/3/2017, answer due 4/4/2017. (MAZESKI, VINCENT) (Entered: 02/06/2017)
54 NOTICE of Appearance by VINCENT R. MAZESKI on behalf of RICH WENHOLD with Certificate of Service(MAZESKI, VINCENT) (Entered: 02/06/2017)
55 DEMAND for Trial by Jury by RICH WENHOLD. (MAZESKI, VINCENT) (Entered: 02/06/2017)
56 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by PAUL NOEL, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), RICH WENHOLD, JOHN WETZEL.Certificate of Service. (Attachments: # 1 Text of Proposed Order)(MAZESKI, VINCENT) (Entered: 02/08/2017)
57 Memorandum in Support re 56 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by PAUL NOEL, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), RICH WENHOLD, JOHN WETZEL. (MAZESKI, VINCENT) (Entered: 02/08/2017)
58 MOTION to Stay Proceedings filed by PAUL NOEL, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), RICH WENHOLD, JOHN WETZEL. Certificte of Service. (Attachments: # 1 Text of Proposed Order)(MAZESKI, VINCENT) Modified on 2/10/2017 (tjd). (Entered: 02/08/2017)
59 Memorandum re 58 MOTION to Stay filed by PAUL NOEL, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), RICH WENHOLD, JOHN WETZEL. (MAZESKI, VINCENT) (Entered: 02/08/2017)
60 MOTION to Stay Discovery filed by PAUL NOEL, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), RICH WENHOLD, JOHN WETZEL. Certificate of Service. (Attachments: # 1 Text of Proposed Order)(MAZESKI, VINCENT)(WITHDRAWN PER ORDER #78) Modified on 2/10/2017 (tjd). Modified on 4/5/2017 (pr, ). (Entered: 02/08/2017)
61 Memorandum in Support re 60 MOTION to Stay filed by PAUL NOEL, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), RICH WENHOLD, JOHN WETZEL. (MAZESKI, VINCENT) (Entered: 02/08/2017)
62 MOTION for Extension of Time to File Response/Reply as to 58 MOTION to Stay , 56 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM , 60 MOTION to Stay filed by SALVATORE CHIMENTI, DANIEL LEYVA, DAVID MALDONADO.Certificate of Service. (Attachments: # 1 Text of Proposed Order)(YEH, SU MING) (Entered: 02/17/2017)
63 MOTION to Dismiss filed by CORRECT CARE SOLUTIONS (CCS), JAY COWAN, JAMES FROMMER, KEPHART, WEXFORD HEALTH SOURCES, INC..Certificate of Service. (Attachments: # 1 Text of Proposed Order)(FOREMAN, SAMUEL) (Entered: 02/21/2017)
64 Brief in Support re 63 MOTION to Dismiss filed by CORRECT CARE SOLUTIONS (CCS), JAY COWAN, JAMES FROMMER, KEPHART, WEXFORD HEALTH SOURCES, INC. Certificate of Service. (FOREMAN, SAMUEL) Modified on 2/22/2017 (tjd). (Entered: 02/21/2017)
65 ORDER THAT PLFF'S MOTION FOR EXTENSION OF TIME TO RESPOND TO DEFTS' MOTION TO DISMISS AND MOTIONS TO STAY, PLFFS' MOTION IS GRANTED. PLFFS. SHALL FILE THEIR RESPONSE (S) ON OR BEFORE 3/6/17. SIGNED BY HONORABLE JOHN R. PADOVA ON 2/21/17.2/21/17 ENTERED AND COPIES E−MAILED TO COUNSEL. (pr, ) (Entered: 02/21/2017)
66 MOTION for Extension of Time to File Response/Reply as to 56 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM , 63 MOTION to Dismiss filed by SALVATORE CHIMENTI, DANIEL LEYVA, DAVID MALDONADO.Certificate of Service. (Attachments: # 1 Text of Proposed Order)(YEH, SU MING) (Entered:

Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 12 of 17

02/23/2017
03/06/2017 03/08/2017 03/08/2017 03/09/2017 03/10/2017 03/13/2017
03/15/2017 03/17/2017 03/29/2017 04/05/2017 04/05/2017
04/17/2017

02/22/2017)
67 ORDER THAT PLFFS' MOTION FOR EXTENSION OF TIME TO RESPOND TO DEFTS' MOTIONS TO DISMISS IS GRANTED. PLFFS. SHALL FILE THEIR RESPONSE(S) TO THE MOTION TO DISMISS FILED BY DOC DEFTS. AND THE MOTION TO DISMISS FILED BY THE CORRECT CARE SOLUTIONS AND WEXFORD DEFTS. ON OR BEFORE 3/15/17. SIGNED BY HONORABLE JOHN R. PADOVA ON 2/23/17.2/23/17 ENTERED AND COPIES E−MAILED TO COUNSEL. (pr, ) (Entered: 02/23/2017)
68 RESPONSE in Opposition re 58 MOTION to Stay , 60 MOTION to Stay filed by SALVATORE CHIMENTI. (Attachments: # 1 Text of Proposed Order, # 2 Exhibit 1)(YEH, SU MING) (Entered: 03/06/2017)
69 REPLY to Response to Motion re 60 MOTION to Stay filed by PAUL NOEL, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), RICH WENHOLD, JOHN WETZEL. (MAZESKI, VINCENT) (Entered: 03/08/2017)
70 REPLY to Response to Motion re 58 MOTION to Stay , 60 MOTION to Stay filed by CORRECT CARE SOLUTIONS (CCS), JAY COWAN, JAMES FROMMER, KEPHART, WEXFORD HEALTH SOURCES, INC.. (FOREMAN, SAMUEL) (Entered: 03/08/2017)
71 ORDER THAT DEFTS' JOINT MOTION TO STAY PROCEEDINGS (DOC. NO. 58) IS DENIED.. SIGNED BY HONORABLE JOHN R. PADOVA ON 3/8/17.3/9/17 ENTERED AND COPIES E−MAILED TO COUNSEL.(pr, ) (Entered: 03/09/2017)
72 Joint MOTION for Extension of Time to Complete Discovery filed by SALVATORE CHIMENTI.Certificate of Service. (Attachments: # 1 Text of Proposed Order)(YEH, SU MING) (Entered: 03/10/2017)
73 ORDER THAT THE MOTION TO EXTEND TIME FOR DISCOVERY IS GRANTED. IT IS FURTHER ORDERED THAT CLASS CERTIFICATION AND MERITS DISCOVERY IS COMPLETED BY APRIL 17, 2017 AND DISPOSITIVE MOTIONS SHALL BE FILED BY AUGUST 1, 2017 ETC. SIGNED BY HONORABLE JOHN R. PADOVA ON 3/13/17.3/13/17 ENTERED AND COPIES EMAILED TO COUNSEL.(jaa, ) (Entered: 03/13/2017)
74 RESPONSE in Opposition re 56 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM , 63 MOTION to Dismiss filed by SALVATORE CHIMENTI, DANIEL LEYVA, DAVID MALDONADO. (Attachments: # 1 Text of Proposed Order, # 2 Exhibit A, # 3 Exhibit B)(YEH, SU MING) (Entered: 03/15/2017)
75 NOTICE of Hearing: ORAL ARGUMENT IS SET FOR 4/4/2017 AT 02:00 PM IN COURTROOM 17B BEFORE HONORABLE JOHN R. PADOVA.(cl, ) (Entered: 03/17/2017)
76 Reply Brief re 56 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by PAUL NOEL, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), RICH WENHOLD, JOHN WETZEL. (MAZESKI, VINCENT) Modified on 3/30/2017 (tjd). (Entered: 03/29/2017)
77 Minute Entry for proceedings held before HONORABLE JOHN R. PADOVA Oral Argument held on 4/4/17. Court Reporter: ESR. Hearing taken under advisement. (pr, ) (Entered: 04/05/2017)
78 ORDER THAT DEFTS' REQUEST TO WITHDRAW "DEFTS' JOINT MOTION TO STAY DISCOVERY" (DOC. NO. 60) IS GRANTED AND THE MOTION IS WITHDRAWN.. SIGNED BY HONORABLE JOHN R. PADOVA ON 4/4/17.4/5/17 ENTERED AND COPIES MAILED AND E−MAILED TO COUNSEL. Modified on 4/5/2017 (pr, ). (Entered: 04/05/2017)
79 MOTION for Extension of Time to Complete Discovery filed by PAUL NOEL, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), RICH WENHOLD, JOHN WETZEL.Certificate of Service. (Attachments: # 1 Text of Proposed Order)(MAZESKI, VINCENT) (Entered: 04/17/2017)

Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 13 of 17

04/17/2017 04/18/2017
04/18/2017 04/27/2017 04/27/2017 05/15/2017 05/16/2017
05/17/2017 05/25/2017 07/25/2017 07/25/2017 08/08/2017 08/08/2017

80 STATUS REPORT by PAUL NOEL, PENNSYLVANIA DEPARTMENT CORRECTIONS (DOC), RICH WENHOLD, JOHN WETZEL. (MAZESKI, VINCENT) (Entered: 04/17/2017)
81 ORDER THAT DEFENDANTS' 79 MOTION FOR EXTENSION OF TIME TO COMPLETE DISCOVERY IS GRANTED. CLASS CERTIFICATION AND MERITS DISCOVERY IS DUE 5/17/2017. EXPERT REPORTS ARE DUE ON OR BEFORE 6/16/2017. EXPERT DISCOVERY IS DUE 7/17/2017. DISPOSITIVE MOTIONS ARE DUE 9/1/2017. RENEWED CLASS CERTIFICATION MOTIONS ARE DUE 9/1/2017. RESPONSES TO DISPOSITIVE MOTIONS OR RENEWED CLASS CERTIFICATION MOTIONS ARE DUE 10/2/2017 WITH REPLIES DUE 10/16/2017. SIGNED BY HONORABLE JOHN R. PADOVA ON 4/18/2017.4/19/2017 ENTERED AND COPIES MAILED, E−MAILED.(kp, ) Modified on 4/19/2017 (kp, ). (Main Document 81 replaced on 4/19/2017) (kp, ). (Entered: 04/19/2017)
Set/Reset Scheduling Order Deadlines: DISCOVERY DUE BY 7/17/2017. MOTIONS DUE BY 9/1/2017. (kp, ) (Entered: 04/19/2017)
82 MOTION for Leave to Depose Prisoner filed by CORRECT CARE SOLUTIONS (CCS), JAY COWAN, JAMES FROMMER, JOHN KEPHART, WEXFORD HEALTH SOURCES, INC..Certificate of Service. (Attachments: # 1 Text of Proposed Order)(FOREMAN, SAMUEL) (Entered: 04/27/2017)
83 ORDER THAT UPON CONSIDERATION OF DEFENDANT'S MOTION FOR LEAVE TO DEPOSE PRISONER, IT IS ORDERED THAT SAID MOTION IS GRANTED. SIGNED BY HONORABLE JOHN R. PADOVA ON 4/27/17.4/27/17 ENTERED AND COPIES MAILED, E−MAILED.(gs) (Entered: 04/27/2017)
84 MOTION for Extension of Time to Complete Discovery filed by CORRECT CARE SOLUTIONS (CCS), JAY COWAN, JAMES FROMMER, JOHN KEPHART, WEXFORD HEALTH SOURCES, INC..Certificate of Service. (Attachments: # 1 Text of Proposed Order)(FOREMAN, SAMUEL) (Entered: 05/15/2017)
85 ORDER THAT DEFTS' MOTION FOR EXTENSION OF TIME TO COMPLETE DISCOVERY IS GRANTED, AND THE PENDING DOCKETED DEADLINES CHANGED TO THE FOLLOWING: DISCOVERY CLOSES ON 6/19/17; EXPERT REPORTS ARE DUE BY 7/17/17; EXPERT DISCOVERY IS DUE BY 8/17/17; DISPOSITIVE MOTIONS DUE 10/2/17; RENEWED CLASS CERTIFICATION MOTIONS DUE 10/2/17; RESPONSES TO DISPOSITIVE MOTIONS OR RENEWED CLASS CERTIFICATION MOTION DUE 11/2/17, WITH REPLIES DUE 11/16/17.. SIGNED BY HONORABLE JOHN R. PADOVA ON 5/15/17.5/16/17 ENTERED AND COPIES E−MAILED TO COUNSEL.(pr, ) (Entered: 05/16/2017)
86 NOTICE of Hearing:A TELEPHONE CONFERENCE IS SET FOR 5/23/2017 AT 11:30 AM BEFORE HONORABLE JOHN R. PADOVA.(cl, ) (Entered: 05/17/2017)
87 Minute Entry for proceedings held before HONORABLE JOHN R. PADOVA Telephone Conference held on 5/23/2017(kp, ) (Entered: 05/25/2017)
88 STIPULATION −− Amended Stipulated Protective Order by SALVATORE CHIMENTI. (Attachments: # 1 Certificate of Service)(YEH, SU MING) (Entered: 07/25/2017)
89 AMENDED STIPULATED PROTECTIVE ORDER THAT THE TERM "CONFIDENTIAL INFORMATION" REFERS TO HEALTH INFORMATION CONTAINED IN THE INMATES' MEDICAL RECORDS AND FILES, ETC.. SIGNED BY HONORABLE JOHN R. PADOVA ON 7/25/17. 7/26/17 ENTERED AND COPIES E−MAILED TO COUNSEL.(pr, ) (Entered: 07/26/2017)
90 MEMORANDUM. AN APPROPRIATE ORDER FOLLOWS.. SIGNED BY HONORABLE JOHN R. PADOVA ON 8/7/17. 8/8/17 ENTERED AND COPIES E−MAILED TO COUNSEL.(pr, ) (Entered: 08/08/2017)
91 ORDER THAT THE DOC DEFTS' MOTION TO DISMISS AMENDED COMPLAINT (DOC. NO. 56) IS GRANTED IN PART AND DENIED IN PART. THE MOTION IS GRANTED AS TO ALL CLAIMS ASSERTED AGAINST THE

Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 14 of 17

08/22/2017 09/22/2017 10/02/2017 10/02/2017 10/02/2017 10/02/2017 10/02/2017
10/31/2017 10/31/2017 11/02/2017
11/15/2017 11/16/2017

PA DEPT. OF CORRECTIONS AND RICH WENHOLD, AND THOSE DEFTS. ARE DISMISSED AS DEFTS. IN THIS ACTION. THE MOTION TO DISMISS THE AMENDED COMPLAINT FILED BY THE MEDICAL DEFTS. (DOC. NO. 63) IS GRANTED IN PART AND DENIED IN PART.. SIGNED BY HONORABLE JOHN R. PADOVA ON 8/7/17. 8/8/17 ENTERED AND COPIES E−MAILED TO COUNSEL.(pr, ) (Entered: 08/08/2017)
92 ANSWER to 50 Amended Complaint, with Affirmative Defenses, by CORRECT CARE SOLUTIONS (CCS), JAY COWAN, JAMES FROMMER, JOHN KEPHART, WEXFORD HEALTH SOURCES, INC., Certificate of Service.(GOODRICH, CAITLIN) Modified on 8/24/2017 (md). (Entered: 08/22/2017)
93 ANSWER to 50 Amended Complaint, by PAUL NOEL, JOHN WETZEL. Affirmative Defenses, Certificate of Service.(MAZESKI, VINCENT) Modified on 9/25/2017 (tjd). (Entered: 09/22/2017)
94 MOTION to Certify Class filed by SALVATORE CHIMENTI.Memorandum, Certificate of Service. (Attachments: # 1 Memorandum, # 2 Certificate of Service, # 3 Exhibit A, # 4 Exhibit B, # 5 Exhibit C, # 6 Exhibit D, # 7 Exhibit E, # 8 Exhibit F, # 9 Exhibit G, # 10 Exhibit H, # 11 Exhibit I, # 12 Exhibit J, # 13 Exhibit K, # 14 Exhibit L)(WONG, ROSE MARIE) (Entered: 10/02/2017)
95 MOTION for Summary Judgment filed by PAUL NOEL, JOHN WETZEL.Certificate of Service. (Attachments: # 1 Text of Proposed Order)(MAZESKI, VINCENT) (Entered: 10/02/2017)
96 Brief in Support re 95 MOTION for Summary Judgment filed by PAUL NOEL, JOHN WETZEL. (MAZESKI, VINCENT) Modified on 10/4/2017 (tjd). (Entered: 10/02/2017)
97 Statement of Material Facts by PAUL NOEL, JOHN WETZEL. (MAZESKI, VINCENT) (Entered: 10/02/2017)
98 Appendix in Support re 95 MOTION for Summary Judgment filed by PAUL NOEL, JOHN WETZEL. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12 Exhibit L, # 13 Exhibit M, # 14 Exhibit N, # 15 Exhibit O1, # 16 Exhibit O2, # 17 Exhibit O3, # 18 Exhibit O4, # 19 Exhibit P, # 20 Exhibit Q, # 21 Exhibit R1, # 22 Exhibit R2, # 23 Exhibit R3, # 24 Exhibit S, # 25 Exhibit T1, # 26 Exhibit T2, # 27 Exhibit U, # 28 Exhibit V, # 29 Exhibit W, # 30 Exhibit X, # 31 Exhibit Y, # 32 Exhibit Z)(MAZESKI, VINCENT) Modified on 10/4/2017 (tjd). (Entered: 10/02/2017)
99 ANSWER re 94 MOTION to Certify Class filed by PAUL NOEL, JOHN WETZEL. Certificate of Service. (MAZESKI, VINCENT) Modified on 11/1/2017 (lisad, ). (Entered: 10/31/2017)
100 BRIEF in Opposition re 94 MOTION to Certify Class filed by PAUL NOEL, JOHN WETZEL. Certificate of Service. (MAZESKI, VINCENT) Modified on 11/1/2017 (lisad, ). (Entered: 10/31/2017)
101 RESPONSE in Opposition re 95 MOTION for Summary Judgment filed by SALVATORE CHIMENTI, DANIEL LEYVA, DAVID MALDONADO. (Attachments: # 1 Text of Proposed Order, # 2 Response to Statement of Facts, # 3 Table of Contents, # 4 Exhibit A, # 5 Exhibit B, # 6 Exhibit C, # 7 Exhibit D, # 8 Exhibit E, # 9 Exhibit F, # 10 Exhibit G, # 11 Exhibit H, # 12 Exhibit I, # 13 Exhibit J, # 14 Exhibit K, # 15 Exhibit L, # 16 Exhibit M, # 17 Exhibit N, # 18 Exhibit O, # 19 Exhibit P, # 20 Exhibit Q, # 21 Exhibit R, # 22 Exhibit S, # 23 Exhibit T, # 24 Exhibit U, # 25 Exhibit V, # 26 Exhibit W, # 27 Exhibit X)(YEH, SU MING) (Entered: 11/02/2017)
102 REPLY to Response to Motion re 94 MOTION to Certify Class filed by SALVATORE CHIMENTI, DANIEL LEYVA, DAVID MALDONADO. (Attachments: # 1 Certificate of Service)(WONG, ROSE MARIE) (Entered: 11/15/2017)
103 RESPONSE to Counterstatement of Additional Facts re 95 MOTION for Summary Judgment filed by PAUL NOEL, JOHN WETZEL. Certificate of Service. (MAZESKI,

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11/16/2017 11/28/2017 03/02/2018 05/24/2018 05/24/2018
07/12/2018 07/12/2018 07/17/2018 07/23/2018 07/25/2018 07/25/2018 07/25/2018 07/26/2018
07/26/2018

VINCENT) Modified on 11/17/2017 (lisad, ). (Entered: 11/16/2017)
104 REPLY Brief in Support re 95 MOTION for Summary Judgment filed by PAUL NOEL, JOHN WETZEL. Certificate of Service. (MAZESKI, VINCENT) Modified on 11/17/2017 (lisad, ). (Entered: 11/16/2017)
105 NOTICE by SALVATORE CHIMENTI re 94 MOTION to Certify Class Notice of Supplemental Authority (Attachments: # 1 Exhibit Supplemental Authority, # 2 Certificate of Service)(WONG, ROSE MARIE) (Entered: 11/28/2017)
106 NOTICE by SALVATORE CHIMENTI re 94 MOTION to Certify Class Second Notice of Supplemental Authority (Attachments: # 1 Exhibit Supplemental Authority, # 2 Certificate of Service)(WONG, ROSE MARIE) (Entered: 03/02/2018)
107 MEMORANDUM AND/OR OPINION. SIGNED BY HONORABLE JOHN R. PADOVA ON 5/24/18. 5/25/18 ENTERED AND COPIES EMAILED TO COUNSEL.(jaa, ) (Entered: 05/25/2018)
108 ORDERED THAT PLAINTIFFS' RENEWED MOTION FOR CLASS CERTIFICATION, AND ALL DOCUMENTS FILED IN CONNECTION THEREWITH, AND FOR THE REASONS STATED IN THE ACCOMPANYING MEMORANDUM IS GRANTED AS OUTLINED HEREIN. SIGNED BY HONORABLE JOHN R. PADOVA ON 5/24/18. 5/25/18 ENTERED AND COPIES EMAILED TO COUNSEL.(jaa, ) (Entered: 05/25/2018)
109 MEMORANDUM. AN APPROPRIATE ORDER FOLLOWS.. SIGNED BY HONORABLE JOHN R. PADOVA ON 7/12/18. 7/12/18 ENTERED AND COPIES E−MAILED TO COUNSEL.(pr, ) (Entered: 07/12/2018)
110 ORDER THAT DOC DEFTS' MOTION FOR SUMMARY JUDGMENT (DOC. NO. 95) IS GRANTED IN PART AND DENIED IN PART, ETC.. SIGNED BY HONORABLE JOHN R. PADOVA ON 7/12/18. 7/12/18 ENTERED AND COPIES E−MAILED TO COUNSEL.(pr, ) (Entered: 07/12/2018)
111 NOTICE of Hearing: STATUS CONFERENCE IS SET FOR JULY 25,2018 AT 11:00 A.M. IN JUDGE CHAMBERS BEFORE HONORABLE JOHN R. PADOVA.(pk, ) (Entered: 07/17/2018)
112 STIPULATION of Dismissal (Partial) by CORRECT CARE SOLUTIONS (CCS), JAY COWAN, ANDREW DANCHA, JAMES FROMMER, JOHN KEPHART, WEXFORD HEALTH SOURCES, INC.. (Attachments: # 1 Text of Proposed Order)(FOREMAN, SAMUEL) (Entered: 07/23/2018)
113 Minute Entry/Report of Status Conference for proceedings held before HONORABLE JOHN R. PADOVA on 7/25/18. (kw, ) (Entered: 07/25/2018)
114 MOTION for Reconsideration re 110 Order (Memorandum and/or Opinion) filed by PAUL NOEL, JOHN WETZEL.Certificate of Service. (Attachments: # 1 Text of Proposed Order)(MAZESKI, VINCENT) (Entered: 07/25/2018)
115 Memorandum in Support re 114 MOTION for Reconsideration re 110 Order (Memorandum and/or Opinion) filed by PAUL NOEL, JOHN WETZEL. (MAZESKI, VINCENT) (Entered: 07/25/2018)
116 ORDER THAT PLFF. SALVATORE CHIMENTI'S CLAIMS FOR MONETARY DAMAGES ASSERTED AGAINST DEFTS. DR. JOHN KEPHART, DR. JAMES FROMMER, AND DR. JAY COWAN IN COURTS I AND III OF THE FIRST AMENDED COMPLAINT ARE DISMISSED WITH PREJUDICE; IT IS FURTHER ORDERED THAT DR. KEPHART, DR. FROMMER, AND DR. COWAN ARE DISMISSED AS DEFTS. IN THIS ACTION.. SIGNED BY HONORABLE JOHN R. PADOVA ON 7/25/18. 7/26/18 ENTERED AND COPIES E−MAILED TO COUNSEL.(pr, ) (Entered: 07/26/2018)
117 AMENDED SCHEDULING ORDER THAT A SETTLEMENT CONFERENCE FOR THIS MATTER WILL BE HELD ON OR BEFORE 10/31/2018 BEFORE U.S. MAGISTRATE JUDGE TIMOTHY R. RICE, ETC. PLAINTIFF'S PRETRIAL MEMO DUE BY 11/12/2018. DEFENDANT'S PRETRIAL MEMO DUE BY 11/19/2018. ALL MOTIONS IN LIMINE DUE BY 11/19/2018. FINAL PRETRIAL

Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 16 of 17

08/06/2018 08/09/2018 08/09/2018 08/20/2018 08/30/2018 09/20/2018 10/17/2018 11/19/2018
11/27/2018
11/27/2018 01/11/2019 01/11/2019 01/11/2019 01/11/2019 01/14/2019

CONFERENCE SET FOR 12/3/2018 AT 2:00 P.M. IN CHAMBERS (ROOM 17613) TRIAL POOL SET FOR 12/10/2018, ETC. SIGNED BY HONORABLE JOHN R. PADOVA ON 7/26/18. 7/27/18 ENTERED AND COPIES E−MAILED.(kw, ) (Entered: 07/27/2018)
118 NOTICE of Hearing: SETTLEMENT CONFERENCE SET FOR 10/17/2018 AT 9:30 A.M. IN JUDGE'S CHAMBERS (ROOM 3029) BEFORE MAGISTRATE JUDGE TIMOTHY R. RICE.(cms) (Entered: 08/06/2018)
119 RESPONSE in Opposition re 114 MOTION for Reconsideration re 110 Order (Memorandum and/or Opinion) filed by SALVATORE CHIMENTI, DANIEL LEYVA, DAVID MALDONADO. (Attachments: # 1 Text of Proposed Order)(YEH, SU MING) (Entered: 08/09/2018)
120 REPLY to Response to Motion re 114 MOTION for Reconsideration re 110 Order (Memorandum and/or Opinion) filed by PAUL NOEL, JOHN WETZEL. (MAZESKI, VINCENT) (Entered: 08/09/2018)
121 ORDER THAT THE DOC DEFENDANTS' MOTION FOR RECONSIDERATION, AND ALL DOCUMENTS FILED IN CONNECTION THEREWITH IS DENIED. SIGNED BY HONORABLE JOHN R. PADOVA ON 8/20/18.8/21/18 ENTERED AND COPIES EMAILED TO COUNSEL.(jaa, ) (Entered: 08/21/2018)
122 STIPULATION of Dismissal of Fewer than All Defendants by CORRECT CARE SOLUTIONS (CCS), WEXFORD HEALTH SOURCES, INC.. (Attachments: # 1 Text of Proposed Order)(FOREMAN, SAMUEL) (Entered: 08/30/2018)
123 STIPULATION of Dismissal by PAUL NOEL, JOHN WETZEL. (MAZESKI, VINCENT) (Entered: 09/20/2018)
124 Minute Entry for proceedings held before MAGISTRATE JUDGE TIMOTHY R. RICE Settlement Conference held on 10/17/2018. (sg, ) (Entered: 10/17/2018)
125 Consent MOTION for Approval Preliminary of Class Action Settlement filed by SALVATORE CHIMENTI, DANIEL LEYVA, DAVID MALDONADO.Memorandum, Certificate of Counsel. (Attachments: # 1 Text of Proposed Order, # 2 Exhibit 1: Class Action Settlement Agreement, # 3 Exhibit 2: Proposed Notice to Class)(YEH, SU MING) (Entered: 11/19/2018)
126 ORDER THAT THE SETTLEMENT AGREEMENT ENTERED IN TO BETWEEN THE PARTIES APPEARS, UPON PRELIMINARY REVIEW, TO BE FAIR, REASONABLE, AND IN THE BEST INTEREST OF THE CLASS AND THE SETTLEMENT AGREEMENT IS PRELIMINARILY APPROVED; ON OR BEFORE 12/10/18, "NOTICE TO THE CLASS OF THE SETTLEMENT AGREEMENT" SHALL BE POSTED AND DISTRIBUTED IN ACCORDANCE WITH SECTION 6, PAGE 7, OF THE SETTLEMENT AGREEMENT AND EXHIBIT 2 TO THE SETTLEMENT AGREEMENT. THE PARTIES SHALL FILE ALL MEMORANDA RELATING TO FINAL APPROVAL OF THE SETTLEMENT AGREEMENT NO LATER THAN 1/24/19, ETC.. SIGNED BY HONORABLE JOHN R. PADOVA ON 11/26/18. 11/28/18 ENTERED AND COPIES E−MAILED TO COUNSEL.(pr, ) (Entered: 11/28/2018)
Set/Reset Hearings: MISCELLANEOUS HEARING SET FOR 2/5/2019 10:00 AM BEFORE HONORABLE JOHN R. PADOVA. (tjd) (Entered: 11/30/2018)
127 NOTICE filed by HERMAN WILKES re: Objection to Settlement. (pr, ) (Entered: 01/16/2019)
128 Objection to Settlement filed by BARRY JONES. (pr, ) (Entered: 01/16/2019)
129 Objection to Settlement filed by WILLIAMS HAY. (pr, ) (Entered: 01/16/2019)
130 Objection to Settlement filed by CHRISTOPHER SINGLETARY. (pr, ) (Entered: 01/16/2019)
131 Plff's Objection to Class Action Settlement Agreement filed by GABRIEL PITTMAN. Cert. of Service. (pr, ) (Entered: 01/16/2019)

Case: 2:15-cv-3333 As of: 06/11/2019 12:28 PM EDT 17 of 17

01/14/2019 01/15/2019 01/17/2019 01/24/2019
02/06/2019 02/06/2019
02/06/2019 02/07/2019

132 NOTICE of Objection to the Settlement Agreement filed by BIENVENIDO RODRIGUEZ, JR. Cert. of Service. (pr, ) (Entered: 01/16/2019)
133 Objection filed by JAMES BROWN. Cert. of Service. (pr, ) (Entered: 01/17/2019)
134 NOTICE OF OBJECTIONS TO SETTLEMENT AGGREEMENT WITH CERTIFICATE OF SERVICE FILED BY STEVEN CURTICIAN. (jaa, ) (Entered: 01/18/2019)
135 Joint MOTION for Approval (FINAL) of Class Action Settlement filed by SALVATORE CHIMENTI, DANIEL LEYVA, DAVID MALDONADO.Memorandum, Certificate of Service. (Attachments: # 1 Text of Proposed Order, # 2 Exhibit 1, # 3 Exhibit 2)(YEH, SU MING) (Entered: 01/24/2019)
136 Minute Entry for proceedings held before HONORABLE JOHN R. PADOVA Motion for Approval of Class Action Settlement was held on 2/5/19 Court Reporter: ESR. (jaa, ) Modified on 2/7/2019 (tjd). (Entered: 02/06/2019)
137 ORDER THAT THE COURT'S EXHIBITS 1, 2, AND 3 AT THE MOTION HEARING HELD ON 2/5/19 ARE SEALED AND IMPOUNDED UNTIL FURTHER ORDER OF THE COURT.. SIGNED BY HONORABLE JOHN R. PADOVA ON 2/6/19. 2/7/19 ENTERED AND COPIES E−MAILED TO COUNSEL.(pr, ) (Entered: 02/07/2019)
138 EXHIBITS 1, 2, and 3 presented at the Motion Hearing on 2/5/19 are filed under seal. (pr, ) (tjd, ). (Entered: 02/07/2019)
139 ORDER THAT THE JOINT MOTION SEEKING FINAL APPROVAL OF CLASS ACTION SETTLEMENT IS GRANTED; THE SETTLEMENT AGREEMENT IS APPROVED PURSUANT TO FRCP 23(e). THE ATTORNEYS' FEES AS OUTLINED IN THE SETTLEMENT AGREEMENT ARE GRANTED; THE COURT EXPRESSLY RETAINS JURISDICTION UNTIL 6/30/22. SIGNED BY HONORABLE JOHN R. PADOVA ON 2/7/19.2/8/19 ENTERED AND COPIES E−MAILED TO COUNSEL.(pr, ) (Entered: 02/08/2019)