Opinion ID: 183790
Heading Depth: 1
Heading Rank: 1

Heading: facts

Text: Each of the plaintiffs claims that, during his incarceration in IDOC, he was refused or delayed treatment for hepatitis C and that he suffered some further injury as a result. The plaintiffs contend that Dr. Elyea, the IDOC Medical Director from 2002-2007, knowingly instituted a protocol for the diagnosis and treatment of hepatitis C that fell below constitutionally acceptable standards of medical care for inmates. To facilitate an understanding of the specific claims, we first discuss the record evidence about the disease and the IDOC response to it and then discuss each plaintiff's particular medical situation. The only record evidence regarding the disease, as a general matter, comes from the Federal Bureau of Prison (FBOP) Clinical Practice Guidelines for the Prevention and Treatment of Viral Hepatitis (the Guidelines) [2] and the testimony of Dr. Elyea himself.
Hepatitis C is a disease caused by a virus known as HCV. It has the potential to affect liver functioning. The HCV virus has six genotypes, the first of which is the prevalent form in the United States. HCV is transmitted by blood-to-blood contact, including, with some frequency, during tattooing or other shared-needle activities. In the acute phase, individuals may have a variety of symptoms that are only rarely severe and may include jaundice, nausea, anorexia and malaise. HCV infection can resolve spontaneously from the acute phase, but an estimated 50-85% of infected persons develop chronic infection. Even among patients with chronic hepatitis C, the majority are asymptomatic. One-third of persons with chronic HCV infection show no evidence of liver disease. However, some 10-15% of infected persons show progressive fibrosis that leads to cirrhosis. Dr. Elyea testified at trial that there is no reliable way of predicting which chronic HCV patients will develop cirrhosis. R.110 at 164. However, according to the FBOP Guidelines upon which IDOC policy purportedly was based, known risk factors for disease progression include high levels of alcohol consumption, male gender, older age and simultaneous infection with other viruses such as HIV or HBV (the hepatitis B virus). As of 2003, viral load (the degree of virus present in the bloodstream of a particular individual at a particular time) and the particular genotype of HCV were not thought to affect the risk of progression of disease. [3] When the disease causes liver failure, a liver transplant may be necessary. In addition to the risks of cirrhosis itself, liver cancer in individuals with cirrhosis develops at a rate of about 1-4% per year. These potentially serious conditions frequently develop in infected individuals up to twenty or thirty years after initial infection. Because of its usual means of transmission, HCV is a fairly common virus in the prison population, and the FBOP Guidelines prescribe a specific course of diagnosis and treatment in federal facilities. The FBOP Guidelines direct that a baseline evaluation should be conducted for all inmates diagnosed with chronic hepatitis C. Trial Ex. 3 at 39-40. That evaluation should include at least a [t]argeted history and physical examination to evaluate for signs and symptoms of liver disease, a variety of blood tests, including those for ALT and AST liver enzyme levels and further diagnostic evaluations as clinically warranted, a renal function assessment, and other blood tests and vaccinations. Id. at 39-40. The Guidelines further recommend that inmates with chronic infection should be monitored periodically in chronic care clinics, with the frequency of monitoring to be based on patient-specific factors. Id. at 41. A variety of tests may be used to diagnose and evaluate the progress of disease and determine the appropriateness of treatment. Although blood tests can reveal significant and useful information such as viral load, enzyme responses of the liver and the genotype of the virus, liver biopsy is ultimately the only method discussed in the Guidelines to determine the effect of the disease on the liver. See id. at 42. The appropriateness of treatment with antiviral therapy depends on the extent of the disease. Biopsies are not appropriate in all cases, however, and the Guidelines offer some direction in determining who should be a candidate. When an inmate's initial evaluation shows normal ALT levels, the Guidelines direct that the test should be repeated several times over the next 2 to 12 months. Id. at 42. Persistently normal results are likely indications that there is no marked liver disease. Id. However, even when ALT levels are in the normal range, the Guidelines caution that a ratio of AST/ALT greater than one may indicate underlying liver disease and warrant further evaluation. Id. at 42. When ALT levels are minimally elevated, that is, less than twice normal levels, patients may have mild liver disease but are at low risk of rapid disease progression. Id. at 43. The Guidelines recommend reevaluation in three to six months and note that the decision to obtain a liver biopsy in these inmates should be made on a case-by-case basis. Id. When ALT is twice normal or greater, the Guidelines direct that the tests be repeated at least twice over a six-month period. Inmates with persistent elevations in ALT levels > twice normal should be referred directly for liver biopsy unless antiviral therapy is contraindicated. Id. [4] Finally, [i]nmates with suspected compensated cirrhosis based on clinical and laboratory parameters should be either referred directly for liver biopsy or treated empirically (without biopsy confirmation). Id. After chronic HCV infection is confirmed and the levels indicate that liver biopsy is appropriate, the Guidelines direct that certain inmates should receive treatment in the form of antiviral therapy, a combination of pegylated interferon and ribavirin. Id. at 45-47. Inmates whose biopsies reveal portal or bridging fibrosis and at least moderate inflammation and necrosis are recommended to receive antiviral treatment. Id. at 44. Within that group, [p]ersons with severe liver disease, including compensated cirrhosis, are at higher risk of developing liver complications and should therefore be priority candidates for treatment. Id. Dr. Elyea emphasized in his testimony at trial that the long-term efficacy of antiviral therapy is not known and that it is not always well-tolerated by patients. See R.110 at 167-70. The Guidelines also specifically direct that HCV genotype should be determined prior to ordering antiviral therapy because genotypes 2 and 3 not only have a greater rate of positive response to treatment, but also may be treated with only a twenty-four-week course of the drugs, while genotype 1 requires forty-eight weeks. [5] Finally, the FBOP Guidelines segregate two groups: Detention center/short-term inmates and Long-term (sentenced) inmates. Trial Ex. 3 at 41. The former group should ordinarily not be started on antiviral therapy, and, instead, [t]reatment decision should be deferred until the inmate is sentenced and redesignated or released. Id. Sentenced inmates should be considered for treatment in light of a variety of factors. Among those factors is that the best markers for determining who should be offered antiviral therapy are [t]he presence of moderate to severe fibrosis and inflammation and necrosis on liver biopsy. Id. at 42. The cost of antiviral therapy to reduce the viral load was, at the time of trial, $15,000-$20,000 per year per patient. R.110 at 99.
No documentary evidence was presented at trial of an independent IDOC policy for inmates with chronic hepatitis C infection. Instead, Dr. Elyea testified as to the requirements for treatment in IDOC facilities. The plaintiffs themselves also testified about what their individual treating physicians in the IDOC system told them, and they submitted into the record responses received to grievances filed requesting treatment. Dr. Elyea stated that, in order to establish a consistent treatment plan that covered all inmates, the decision was made to limit follow-up testing and treatment to those individuals who could complete a course of treatment while still incarcerated. See R.110 at 109. In order to allow for a work-up and for a forty-eight-week period of treatment, IDOC would not consider further testing, biopsy or therapy unless an inmate had at least eighteen months [6] remaining in his sentence. According to Dr. Elyea, this limitation was necessary in order to ensure that inmates received an uninterrupted course of therapy. Although not noted in the 2003 Guidelines, the 2005 Guidelines indicate that interrupted antiviral therapy for hepatitis C places inmates at risk for a number of undesirable outcomes, including treatment failure ... and adverse effects from medications if the inmate does not receive the required laboratory and clinical monitoring upon release or transfer. Trial Ex. 4 at 26. Dr. Elyea testified that the blanket sentence-based policy afforded the facilities' health care vendors six months to complete a pre-treatment work-up and then one year to complete treatment, regardless of genotype. R.110 at 90. Dr. Elyea repeatedly testified that the treatment protocol was consistent with the FBOP Guidelines, and, indeed, counsel for Dr. Elyea contended that the IDOC policy was more generous to inmates than the FBOP Guidelines required. He noted that an individual could be an unsentenced detainee in the federal system for as much as two years and the Guidelines recommend deferring treatment until sentencing or release. In his view, because the Guidelines sanctioned a delay of treatment decisions for at least that period for some detainees, IDOC policy was consistent with the Guidelines.

In 1991, during an incarceration prior to Dr. Elyea's term as Medical Director, Mr. Roe was diagnosed with hepatitis C, though his records suggested infection since the 1970s. See Trial Ex. 5 (Grievance of Mr. Roe at 2, Mar. 11, 2004); Doc. 1-279. [7] He was released from custody in 2002. During Dr. Elyea's term, Mr. Roe was incarcerated for two months in 2003 and a little more than eight months, from January 19, 2004 to October 1, 2004. He again was incarcerated from July 2007 until his death in June 2008. During his 2002 incarceration, Mr. Roe had liver enzyme testing and genotype testing. His lab results showed his ALT and AST levels at more than twice normal. [8] They further revealed that his HCV genotype was 3a, and thus, according to the FBOP guidelines in place in 2003, he would have been a candidate for the shorter twenty-four-week course of antiviral therapy. Labs were repeated in 2003 and 2004, each showing elevated liver enzyme levels. Indeed, including the 2002 test, four of the five tests included in the record showed not only ALT levels greater than twice normal, but also an AST/ALT ratio of greater than one, [9] which the Guidelines identify as an indicator of underlying liver disease even when ALT levels are within the normal range, see Trial Ex. 3 at 42. During his 2004 incarceration, Mr. Roe was misdiagnosed and treated briefly for tuberculosis. See Doc. 1-283 (noting the repeated test results). Tuberculosis is a contraindication for antiviral therapy according to the Guidelines. After repeat testing revealed the incorrect diagnosis, Mr. Roe's tuberculosis treatment was discontinued on March 6, 2004, just under seven months from his scheduled release date. During and prior to his 2004 incarceration, Mr. Roe was not considered a candidate for biopsy or antiviral therapy. He also received no treatment following his release. When he returned to prison in 2007, after Dr. Elyea's term had ended but while his policy was still in place, he again received no further testing until one week before trial, when his liver was biopsied. He was, according to the court, visibly quite ill with a distended abdomen at the trial. R.88 at 9. He died three months later, apparently from cirrhosis. R.63-64.
At the time of trial, Mr. Walker had been incarcerated since 1995 and had a scheduled release date in 2011. He was diagnosed with hepatitis C in October 2003, but received no treatment until 2007, after the lawsuit had begun. From 2003 through 2005, several lab reports indicated at least minimal elevation in his ALT and AST levels; at times, the elevation was considerably higher than twice normal levels. See, e.g., Docs. 1-166, 1-176, 1-228. In December 2003, he filed a grievance concerning his lack of treatment. The Health Care Unit Administrator, Dave Huffman, responded that, in order to qualify for treatment, Mr. Walker had to be on the Hepatitis C chronic clinic for 1 year and meet specific lab test results.... After 1 year, if he meets the criterion, treatment will be started because he will still have more than 1 year left to serve. Doc. 1-156. Mr. Walker again grieved the lack of treatment in June 2004, and his grievance was again denied because he did not meet set IDOC treatment criteria. [10] Mr. Walker testified that, although his enzymes were checked periodically, he received no treatment for his HCV infection until he was deposed in connection with the present action in 2007. He was given a liver biopsy and a week later began a course of treatment, after which the virus was undetectable in his body. R.110 at 30. He also testified that, prior to receiving treatment, he suffered from a number of symptoms, including nose bleeds, headaches and pain, all of which had stopped after treatment. Id. at 31-32.
While Dr. Elyea was IDOC Medical Director, Mr. Stasiak was incarcerated from August 2003 through December 2004. He testified that he was diagnosed with hepatitis C in January 2004 and made numerous requests for a liver biopsy and treatment. He complained of symptoms he attributed to his infection, but one medical progress note stated that his claimed symptom of abdominal pain was not due to Hepatitis [and was] possibly musculoskeletal in nature. Doc. 1-128. Mr. Stasiak's enzyme levels were taken numerous times from January through December of 2004, with results varying from more than twice normal to within the normal range. [11] Mr. Stasiak complained to his prison physician that he was not receiving treatment for his HCV infection in February 2004. At that time, the physician noted his out date was only ten months away, and, therefore, he would not meet criteria for treatment during his incarceration. Doc. 1-125. In July 2004, a separate note indicated liver enzyme levels 1. Minimum stay is needed at least of 1 year. Doc. 1-130 (emphasis in original). Mr. Stasiak received no treatment prior to his release.
During Dr. Elyea's tenure, Mr. Stephen was incarcerated for seven months in 2004, seven months from 2005-2006 and two months in 2007. He was diagnosed with hepatitis C during his 2004 incarceration. Throughout his periods of incarceration in 2004 and 2005-2006, his relevant liver enzyme levels were checked numerous times and were always above twice normal. [12] Medical progress notes written in July 2004 noted that, despite his highly elevated enzyme levels, liver biopsy and treatment cannot be accomplished. He needs to stay at least 12-15 months here. Doc. 1-63 (emphasis in original). No medical records were submitted from Mr. Stephen's 2007 incarceration. According to his trial testimony, he suffered a number of symptoms, including abdominal pain and swelling. After his release, he subsequently was scheduled for treatment outside of prison and, at that time, had three liters of fluid removed from his abdomen. R.110 at 73.
The plaintiffs filed the present claim alleging constitutionally inadequate medical care in IDOC facilities. They named Dr. Elyea and several other officials as defendants. The plaintiffs sought, but were denied, class certification. The defendants later sought summary judgment, which was granted in part and denied in part. Specifically, the district court entered judgment for the defendants on claims for injunctive relief by those plaintiffs no longer in IDOC custody and on claims barred by the statute of limitations. R.27. The court also dismissed the official defendants other than Dr. Elyea and his successor. The damages claims of the four plaintiffs arising during Dr. Elyea's tenure proceeded to trial. At trial, the plaintiffs presented no independent expert medical testimony in support of their claims; instead, they relied only on the FBOP Guidelines, their IDOC medical records, their own testimony and Dr. Elyea's adverse testimony. At the close of the plaintiffs' evidence, the defense made its first motion for judgment as a matter of law, arguing that sovereign immunity barred the suit. The motion was denied. The defense then recalled Dr. Elyea to the stand as part of its case-in-chief. After his further testimony, the defense rested, and the jury was excused. [13] Dr. Elyea then again moved for judgment as a matter of law, this time citing qualified immunity among his objections. The motion again was denied, and the case was submitted to the jury. On February 15, 2008, the jury returned its verdict in favor of the plaintiffs, awarding compensatory damages of $20,000 and punitive damages of $2 million to each plaintiff, for a total award of $8,080,000. On March 4, 2008, Dr. Elyea filed a renewed motion for judgment as a matter of law. He further requested, as alternative relief, a new trial or remittitur of the award. On February 18, 2009, the district court issued an opinion and order addressing Dr. Elyea's motion. The court vacated the judgment in favor of Mr. Stephen, Mr. Stasiak and Mr. Walker. It concluded that insufficient evidence supported the verdict in their favor. We shall discuss the specific failings identified by the district court in the context of our discussion of their contentions on appeal. With respect to the remaining plaintiff, Mr. Roe (or, more properly at that stage of the litigation, his estate), the district court denied the defendant's motion on the issue of liability and on the issue of compensatory damages, sustaining the jury's verdict on those matters. The court granted the defendant's motion, however, with respect to the punitive damages award and ordered conditional remittitur of the $2 million award to $20,000, or, at the Estate's election, a new trial on punitive damages. The order stated that the Estate shall file a pleading within 14 days of the entry of this order stating whether [it] accepts or rejects the proposed remittitur of the jury's punitive damage award. Failure to file said pleading shall be deemed an acceptance of the remittitur. R.88 at 20. The judgment entered the following day stated that the 2008 judgment, based on the jury's verdict, was still in effect as to Plaintiff Roe. R.89. The Estate of Mr. Roe did not respond to the conditional remittitur order. On March 18, 2009, the court entered an amended judgment clarifying the award of costs and continued to note that the prior judgment was still in effect as to Plaintiff Roe, despite the fact that more than fourteen days had passed from the conditional remittitur order without a response from Mr. Roe's Estate. R.96. The same day, the plaintiffs filed their notice of appeal. The notice purported to challenge the rulings of the court as to remittitur of Mr. Roe's award and liability of Dr. Elyea with respect to the remaining plaintiffs. On March 24, 2009, the court entered a further order confirming that Mr. Roe's Estate had failed to respond and was deemed to have accepted the remittitur. The court also clarifie[d] that Defendant Puisis, who was substituted for Defendant Elyea in his official capacity after the jury trial for purposes of injunctive relief only, [was] terminated because no injunctive relief is available in this case. R.101 at 2.