Hoffer v. Sec'y, Fla. Dep't of Corr., No. 19-11921

• Decision Date: 31 August 2020
• Docket Number: No. 19-11921
• Parties: Carl HOFFER, Individually and on behalf of a class of persons similarly situated, Ronald McPherson, Individually and on behalf of a class of persons similarly situated, Roland Molina, Individually and on behalf of a class of persons similarly situated, Plaintiffs-Appellees, v. SECRETARY, FLORIDA DEPARTMENT OF CORRECTIONS, Defendant-Appellant.
• Court: U.S. Court of Appeals — Eleventh Circuit

973 F.3d 1263

Carl HOFFER, Individually and on behalf of a class of persons similarly situated, Ronald McPherson, Individually and on behalf of a class of persons similarly situated, Roland Molina, Individually and on behalf of a class of persons similarly situated, Plaintiffs-Appellees,

v.SECRETARY, FLORIDA DEPARTMENT OF CORRECTIONS, Defendant-Appellant.

No. 19-11921

United States Court of Appeals, Eleventh Circuit.

August 31, 2020

Erica A. Selig, Raymond J. Taseff, Dante Pasquale Trevisani, Florida Justice Institute, Miami, FL, for Plaintiffs-Appellees

Amit Agarwal, Karen Ann Brodeen, Ashley Moody, James Hamilton Percival, II, Office of the Attorney General, Tallahassee, FL, Albert J. Bowden, III, Bowden Law Firm, LLC, Tallahassee, FL, for Defendant-Appellant

Before MARTIN, NEWSOM, and BALDOCK,^* Circuit Judges.

NEWSOM, Circuit Judge:

This case principally presents the question whether the Eighth Amendment requires Florida prison officials to treat all inmates with chronic Hepatitis

C—including those who have only mild (or no) liver fibrosis—with expensive, stateof-the-art "direct acting antiviral" (DAA) drugs. The district court held that it does and entered a permanent injunction mandating across-the-board DAA treatment. We hold, to the contrary, that the officials’ current treatment plan—pursuant to which they monitor all HCV-positive inmates, including those who have yet to exhibit serious symptoms, and provide DAAs to anyone who has an exacerbating condition, shows signs of rapid progression, or develops even moderate fibrosis—satisfies constitutional requirements. Accordingly, we reverse the district court's decision, vacate its injunction, and remand for further proceedings.

I

AHepatitis

C—here, HCV—is a bloodborne virus that is commonly spread, among other means, by sharing contaminated needles, utilizing unsterilized tattoo equipment, and engaging in risky sexual behavior. Only about 1% of the general population suffers from the disease, but its prevalence among prison inmates is much higher. Although estimates vary, it's safe to say that thousands—and quite possibly tens of thousands—of inmates confined in Florida state prisons have HCV.

HCV primarily attacks the liver and, in particular, can cause liver scarring

, or "fibrosis." Liver fibrosis can be measured, or staged, on a five-step scale, in ascending order of severity, from F0 (no fibrosis) to F1 (mild fibrosis) to F2 (moderate fibrosis) to F3 (severe fibrosis) to F4 (cirrhosis ). Fortunately, many people afflicted with HCV will "spontaneously clear" the virus without treatment. At least 50% of HCV cases, though, are "chronic," meaning that they can be cured only with medication. Among chronic HCV patients, the disease's rate of progression varies: 30% are stable, meaning that they aren't currently moving up the fibrosis scale; 40% progress slowly, taking several years to advance from one level to another and more than 20 years to reach full-blown cirrhosis ; and 30% progress rapidly, reaching cirrhosis in fewer than 20 years and possibly as few as one.

In years past, HCV patients were prescribed Interferon, a weekly injectable medication that had a number of drawbacks—among them that it required patients to remain sober, caused several unpleasant side effects, and succeeded in eradicating the virus only about 30% of the time. In 2013, a new HCV treatment option arrived on the scene—direct acting antivirals. These DAAs brought great promise—the once- or twice-daily pills were easily administrable, had few side effects, and boasted a 95% cure rate. Unfortunately, and not surprisingly, they also came at great cost. Although the parties dispute the exact price tag of a single 12-week course of DAA treatment—in 2017, the Secretary put it between $25,000 and $37,000 per inmate, while the plaintiffs insisted that discounts and rebates reduced that cost—all agree that DAAs are very expensive.

B

In May 2017, Carl Hoffer, Ronald McPherson, and Roland Molina—chronic-HCV inmates incarcerated in Florida prisons—sued the Secretary of the Florida Department of Corrections on behalf of a putative class in the United States District Court for the Northern District of Florida. Among other claims, the plaintiffs alleged, pursuant to 42 U.S.C. § 1983, that the Secretary's HCV treatment plan—or, at the time, the lack thereof—was deliberately indifferent to inmates’ serious medical needs in violation of the Eighth Amendment. As particularly relevant here, the plaintiffs sought a class-wide injunction requiring the FDC to "develop and adhere to a plan to provide direct-acting antiviral medication to all FDC prisoners with chronic HCV, consistent with the standard of care."

Not long after the plaintiffs filed, the Secretary hired Dr. Daniel Dewsnup to formulate a treatment plan for HCV-infected inmates. Dr. Dewsnup, who had earlier developed and implemented a similar HCV-treatment plan for the Oregon prison system, recommended treating some inmates with DAAs, but not all of them. In particular, he proposed (1) providing DAAs for all inmates at level F2 and above and (2) monitoring F0- and F1-level inmates and treating them with DAAs if they (a) have or develop an exacerbating condition like HIV, (b) exhibit signs of rapid fibrosis progression, or (c) advance to F2. The Secretary adopted Dr. Dewsnup's recommendations.

In October 2017, the district court held a five-day evidentiary hearing, which featured Dr. Dewsnup and the plaintiffs’ expert, Dr. Margaret Koziel. The experts testified concerning a range of topics, but for present purposes our focus is on their dueling conclusions regarding the necessity of treating HCV-positive inmates who show little or no liver scarring—i.e. , those at levels F0 and F1 on the fibrosis scale.

Dr. Koziel "advocate[d]" in favor of treating all HCV-positive inmates with DAAs—even, she said, F0-level inmates, who have "no fibrosis." Her view, she said, comports with guidelines published by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, which recommend DAA treatment for all chronic HCV patients, regardless of staging. Dr. Koziel further testified that "there are clearcut economic benefits to treating all-comers with Hepatitis C

"—in particular, she reported that one paper she had recently reviewed estimated that "the U.S. health system would save about $13 billion by treating everybody."

Regarding medical outcomes, though, Dr. Koziel was more circumspect. As particularly relevant here, the district court judge asked her the following question: "[I]n terms of scoring, F0 to F4, ... what's the tipping point where suddenly [a patient's] chance of getting cancer

is dramatically much greater [or his] chance of permanent damage in terms of liver function ... is greater?" Dr. Koziel began her response by stating that "there is some increased risk of mortality even in the earlier stages" and emphasizing that she "will always advocate for people." "But," she went on, "when I really, really start to get agitated ... is about at F3, and that's when people really get into the irreversible complications because [of] the amount of scar tissue, and at that point I can no longer say to you that we are going to make you completely whole again." Even so, Dr. Koziel reiterated later in her testimony that her job as a physician "is to advocate for the best medical care" and agreed with the district court that "treating everyone who has [HCV] with DAA medication is the best possible management."

For his part, Dr. Dewsnup opined that F0- and F1-level inmates "don't need to be treated immediately" but, rather, "can be deferred." Usually, he said, the FDC only "see[s] them for a few years." At the same time, he recognized that it's different for "lifetime prisoners," whom the FDC is "going to have to treat eventually even if they are Stage 0 or Stage 1." Dr. Dewsnup also explained that the evidence concerning the relationship between the eradication of HCV and F0-and F1-level inmates’ "mortality rates" may suffer from confounding; he acknowledged Interferon-era studies that suggest a correlation between the two, but clarified that "[w]e don't have the scientific data that say[s] that it's the viral eradication that does it." The reason, he said, is because Interferon treatment required patients "to make huge lifestyle changes"—in particular, "[t]hey had to be sober." Because "substance abuse ... [is] the major reason" that HCV-positive inmates die, Dr. Dewsnup didn't believe that the correlation between Interferon treatment for F0s and F1s and decreased mortality rates established the necessary causal link.

Shortly after the hearing, the district court certified a plaintiff class of "all current and future prisoners in FDC custody who have been, or will be, diagnosed with chronic HCV" and entered a preliminary injunction. "[W]ith limited exceptions," the court ordered the FDC to "compl[y] with its own expert's recommendations" and to "formulate a plan" to ensure the treatment of HCV-positive inmates in accordance with a specified schedule. Later, having received the Secretary's plan, the court ordered DAA treatment for prisoners with decompensated cirrhosis

(i.e. , liver failure ) within about a month, prisoners with F4-level cirrhosis within six months, and prisoners with F2 (moderate) and F3 (severe) fibrosis within about a year. The court's preliminary-injunction order did not require DAA treatment for F0- and F1-level inmates unless they had an exacerbating condition.

Several months later, the Secretary moved for summary judgment—in essence, against himself—seeking to make the district court's preliminary injunction permanent. As particularly relevant here, the Secretary reiterated his position that the Eighth Amendment doesn't require immediate DAA treatment of all F0- and F1-level inmates. As a general matter, the Secretary proposed to monitor F0s and F1s, to schedule infirmary visits and lab tests every six...