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Chimenti v. Wetzel

United States District Court, E.D. Pennsylvania

July 12, 2018



          PADOVA, J.

         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 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.


         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; 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 1st 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. (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 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. (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 Defendants[3] 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 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.)


         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 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)).


         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 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 ...

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