Pfaller v. Clarke

• Citation: 630 B.R. 197
• Decision Date: 30 April 2021
• Docket Number: Civil Action No. 3:19cv728
• Court: U.S. District Court — Eastern District of Virginia
• Parties: Jacob PFALLER, Administrator of the Estate of Danny Harold Pfaller Plaintiff, v. Harold CLARKE, et al., Defendants.

630 B.R. 197

Jacob PFALLER, Administrator of the Estate of Danny Harold Pfaller Plaintiff,

v.Harold CLARKE, et al., Defendants.

Civil Action No. 3:19cv728

United States District Court, E.D. Virginia, Richmond Division.

Signed April 30, 2021

Mario Bernard Williams, Dallas S. LePierre, Pro Hac Vice, NDH LLC, Atlanta GA, John Shoreman, Pro Hac Vice, McFadden & Shoreman LLC, Washington DC, for Plaintiff.

Laura Haeberle Cahill, Office of the Attorney General, Laura Elizabeth Maughan, Commonwealth of Virginia Office of the Attorney General, Maurice Scott Fisher, Jr, Lynne Jones Blain, Harman Claytor Corrigan & Wellman, Elizabeth Martin Muldowney, Richmond VA, Jeff Wayne Rosen, Pender & Coward PC, Virginia Beach VA, for Defendants.

MEMORANDUM OPINION

Robert E. Payne, Senior United States District Judge

This matter is before the Court on DEFENDANT'S MOTION FOR SUMMARY JUDGMENT (ECF No. 108) (the "MOTION") filed by Dr. Mark Amonette ("Amonette"). For the reasons set forth below the MOTION will be denied as to Count I and granted as to Count II.

BACKGROUND

I. Procedural Background

This case arises from the death of Danny Harold Pfaller ("Pfaller") of liver cancer

while in the custody of the Virginia Department of Corrections ("VDOC").

Plaintiff Jacob Pfaller ("Plaintiff"), the Administrator of Pfaller's estate, alleges federal constitutional claims and state law tort claims against various defendants in their individual capacities, including Dr. Mark Amonette, VDOC's Medical Director and Chief Physician. Plaintiff brings two claims against Amonette. In Count I, Plaintiff claims that Amonette violated Pfaller's Eighth Amendment right to adequate medical care "by the deliberate enforcement of a policy not consistent with medical standards, which, in effect, denied [Pfaller] screening for liver cancer

, treatment for liver cancer, and treatment for Hepatitis C."¹ Compl. ¶¶ 161, 163, ECF No. 1. Specifically, Plaintiff alleges that the policy (crafted and enforced by Amonette), instructed physicians not to: (1) "treat patients with direct acting antiviral drugs," id. ¶ 170; (2) "refer patients to another physician who could prescribe direct acting antiviral drugs," id. ¶ 171; and (3) "order abdominal imaging for patients with abnormal liver tests to screen for liver cancer," id. ¶ 172. Plaintiff also alleges that, "[t]o the extent that the direct-acting antiviral treatment was not provided because of financial considerations, such concerns are in violation of the U.S. Constitution." Id. ¶ 164. In Count II, Plaintiff claims that Amonette failed "to provide adequate medical care in a supervisory capacity," repeating the allegations that Amonette deliberately enforced a policy not consistent with medical standards and that denial of treatment with direct-acting antiviral drugs for financial reasons violates the constitution. Id. ¶¶ 182-84.

Amonette now moves for summary judgment on three bases: (1) Plaintiff cannot establish deliberate indifference, (2) Plaintiff cannot establish supervisory liability, and (3) Amonette is entitled to qualified immunity.

II. Facts

In late 2014, the FDA approved the use of direct-acting antiviral drugs ("DAAs") to treat Hepatitis C

, a "viral infection that can lead to liver inflammation and scarring." Amonette Aff. ¶¶ 4, 7, ECF No. 110-1. DAAs have a much higher cure rate than earlier treatments. Id. Before 2015, the American Academy for the Study of Liver Disease ("AASLD") recommended a "prioritization of patients [for treatment] based on fibrosis staging and the existence of certain co-morbidities."²

Id. ¶ 8.

In 2015, the AASLD removed the prioritization criteria and recommended "treatment for all HCV-infected persons, except those with limited life expectancy (less than 12 months) due to nonliver-related comorbid conditions." Def.'s Mem. Supp. Ex. 2, at 2, ECF No. 110-2. Nevertheless, the AASLD's guidance acknowledged the need for prioritization where resources limit the ability to treat all patients immediately:

Although treatment is best administered early in the course of the disease before fibrosis progression and the development of complications, the most immediate benefits of treatment will be realized by populations at highest risk for liver-related complications. Thus, where resources limit the ability to treat all infected patients immediately as recommended, it is most appropriate to treat first those at greatest risk of disease complications

and those at risk for transmitting [Hepatitis C ] or in whom treatment may reduce transmission risk. Where such limitations exist, prioritization of immediate treatment for those listed in Tables 3 and 4 is recommended, including patients with progressive liver disease (Metavir stage F3 or F4), transplant recipients, or those with severe extrahepatic manifestations.

Id. The federal Bureau of Prisons also adopted a prioritization strategy in 2016. See generally Def.'s Mem. Supp. Ex. 5, at 30-32, ECF No. 110-5. Both Dr. Travis Schamber, Plaintiff's medical expert witness, and Dr. Chad Zawitz, Amonette's medical expert witness, agree that prioritization is appropriate when resources are limited. See Schamber Dep. 50:17-19, 51:9-15, ECF No. 110-3; Zawitz Dep. 32:2-19, ECF No. 110-13.

After DAAs were approved, VDOC developed interim Hepatitis C

treatment guidelines.³ Amonette Aff. ¶ 9, ECF No. 110-1. At this time, and at all relevant times, Dr. Mark Amonette was the VDOC's Medical Director and Chief Physician. Id. ¶ 2. These interim guidelines were in effect from February 9, 2015 to June 8, 2015. See

generally Def.'s Mem. Supp. Ex. 6, at 1-16, ECF No. 110-6 ("VDOC Guidelines"). Under these guidelines, inmates with an APRI score of 1.0 or higher would be approved for treatment.⁴

Id. at 2. Inmates with an APRI score between 0.7 and 1.0 would be approved for treatment "if there are other findings to suggest advanced liver disease such as low albumin or platelets, or elevated bilirubin or INR." Id.

These interim guidelines were revised by Amonette in collaboration with Dr. Richard Sterling, Chief of Hepatology at Virginia Commonwealth University ("VCU") Health System. Amonette Aff. ¶ 9, ECF No. 110-1. "Dr. Sterling is a nationally recognized expert in Hepatitis C

" and a member of the AASLD since 1991 or 1992. Id.; Sterling Dep. 42:8-18, Feb. 8, 2019, ECF No. 110-7. VDOC issued revised guidelines in June 2015. See

generally VDOC Guidelines at 32-48, ECF No. 110-6. The following month, the hepatology group at VCU Medical Center began to provide treatment to VDOC inmates through the VCU Hepatitis C Telemedicine Clinic ("VCU Telemedicine Clinic"). Amonette Aff. ¶¶ 10, 12, ECF No. 110-1.

The revised guidelines provided criteria, based on inmates' APRI

and FIB-4 scores,⁵ that sorted inmates with Hepatitis C into three groups. Id. ¶ 11. This sorting based on APRI and FIB-4 scores was "designed to immediately refer for evaluation those with F3 and F4 scarring." Id.

Under the revised guidelines: (1) an inmate with an APRI

score greater than 1.5 and a FIB-4 score greater than 3.25 would be "automatically referred to VCU for evaluation without any additional testing"; (2) an inmate with an APRI score between 0.5 and 1.5 or a FIB-4 score between 1.45 and 3.25 would receive "additional testing to determine whether [he or she] should be referred for evaluation"; and (3) an inmate with an APRI score of less than .5 and a FIB-4 score of less than 1.45 would be monitored, i.e., "receive periodic laboratory blood testing and chronic care appointments with a medical provider." Id. The APRI

and FIB-4 thresholds for referral for treatment or testing are listed under the heading "Inclusion Criteria for consideration of treatment." VDOC Guidelines at 19, ECF No. 110-6. The APRI and FIB-4 thresholds for monitoring are listed under the heading "Exclusion criteria." Id. at 21-22.

In addition, inmates who did not meet the inclusion criteria could nevertheless be referred to the VCU Telemedicine Clinic "if there are other findings suggestive of advanced liver disease such as low albumin or Platelets

, or elevated bilirubin or INR, or if there are extra-hepatic conditions that warrant treatment, such as symptomatic cryoglobulins, debilitating fatigue." Id. at 20. Although other aspects of the VDOC Guidelines were revised between June 2015 and May 2018,⁶ these inclusion and exclusion criteria did not change during this time period. See Def.'s Mem. Supp. ¶ 14 n.3, ECF No. 110; VDOC Guidelines at 19-22, 33-34, 50-52, 69-72, 96-97, 114-116, ECF No 110-6. And those criteria are the relevant provisions of the VDOC Guidelines for the purpose of this case.

If a VDOC physician believed an inmate should be referred to VCU, the physician "would forward their medical information, including the results of the recent laboratory resting, to [Amonette]." Amonette Aff. ¶ 12, ECF No. 110-1. If Amonette determined that the inmate's lab results met the criteria in the VDOC Guidelines for referral, he would approve the referral. Id. Amonette testified that he did not generally expect a VDOC physician to refer for treatment inmates who did not meet the VDOC Guidelines criteria nor would he have approved such a referral. Amonette Dep. 55:12-56:12, 57:5-8, ECF No. 128-5. If Amonette approved a referral, the inmate would be seen through VCU's Telemedicine Clinic. Amonette Aff. ¶ 12, ECF No. 110-1. VCU independently determined whether there was a medical reason not to treat the inmate. Id. ¶¶ 12-13. If no such reason existed, VCU would provide the DAA medication through its pharmacy. Id. ¶ 12.

Amonette's expert, Dr. Angel Alsina, interprets the VDOC Guidelines as prioritizing VDOC inmates for DAA treatment. Alsina Rep. at 18, ECF No. 128-3. Schamber, after reviewing one of the VDOC guidelines in place in 2015, interprets those guidelines as excluding some inmates from DAA treatment. Schamber Dep. 144:19-22, 254:4-15, ECF No. 128-1.

Amonette asserts that "VDOC has placed no restraints on the provision of healthcare...