Minnesota DOC Sued Over Failure to Provide New Hepatitis C Treatment Protocol

by Greg Dober

On May 1, 2015, two prisoners at MCF-Stillwater filed a civil rights lawsuit against the Minnesota Department of Corrections, Centurion Managed Care (a division of Centene Corporation), DOC Commissioner Tom Roy and several physicians. The suit alleges that the defendants “refuse to provide the ‘breakthrough’ drug treatment, viz. the hepatitis-C [HCV] treatment community standard-of-care, which will cure Plaintiffs’ HCV infection in three months from its inception.”

According to a press release issued by the International Humanitarian Law Institute, the lawsuit is “the first federal civil rights class action in the nation” to challenge the failure of state prison officials to provide prisoners with a new, more effective hepatitis C treatment protocol.

The plaintiffs, Minnesota state prisoners Ronaldo Ligons and Barry Michaelson, seek to represent a class of similarly situated prisoners. Ligons, incarcerated since 1992, was prescribed the standard 48-week HCV treatment protocol using interferon in 2006. The treatment was not successful. Michaelson initially tested negative for HCV but tested positive for the disease in 2010. The suit states that Michaelson tested positive “only after being double-bunked with a bleeding, HCV-positive cellmate and his exposure to other sources of HCV in MN DOC facilities.”

The treatment protocol the plaintiffs are seeking eliminates interferon as part of the HCV treatment regimen. Interferon, with a combination of other toxic antiviral drugs, was the standard of care prior to the FDA’s recent approval of a new generation of HCV drugs. The interferon regimen requires 24-48 weeks of treatment time and has a much lower efficacy rate with a larger array of side effects. Because the side effects can be so debilitating, many patients withdraw before completing the treatment.

The new generation of HCV drugs includes sofosbuvir, branded as Sovaldi, marketed by Gilead Sciences. It was approved by the FDA in December 2013 and is prescribed as a once-a-day pill, taken for twelve weeks. Trials indicate that the drug has an 84-96% cure rate with fewer side effects than interferon-based treatment regimens. Its efficacy, however, comes at the cost of $1,000 per pill. [See: PLN, July 2014, p.20].

In their lawsuit, Ligons and Michaelson also request access to two other HCV drugs, Harvoni and Viekira Pak. Harvoni, a formulary drug by Gilead Sciences approved by the FDA in October 2014, combines Sovaldi and ledipasvir. Harvoni achieved cure rates of 94-99% in trials and shortened treatment time to as little as eight weeks. Viekira Pak, marketed by pharmaceutical company AbbVie, uses a formulary drug that combines three medications in one pill and is usually taken twice a day for 12 to 24 weeks. In trials, Viekira Pak had an efficacy rate of over 90%. Additional HCV drugs are undergoing final testing, and once approved are expected to lower the cost of the new treatment protocols through competitive pricing.

Ligons and Michaelson argue that the standard of medical care for HCV treatment has changed as a result of the new generation of drugs. The Federal Bureau of Prisons (BOP), Centers for Disease Control, FDA, U.S. Public Health Service and Veterans Administration have recognized this change and are now offering the new HCV drugs.

In May 2014, a BOP clinical practice guidelines report, titled “Interim Guidance for the Management of Chronic Hepatitis C Infection,” noted that the use of sofosbuvir (Sovaldi) and simeprevir in combination with peginterferon and/or ribavirin is the “preferred treatment regimen.” The BOP, which houses approximately 216,800 prisoners, received a 44% discount by purchasing Sovaldi through a U.S. Department of Veterans Affairs program.

Ligons and Michaelson seek to represent a class of approximately 1,350 Minnesota prisoners, or around 15% of the state’s prison system. The proposed class includes those who have not been screened for HCV, those who tested positive but are not receiving the new drug regimens, and prisoners who are HCV-positive but do not know they suffer from the disease and thus have not received treatment. The Minnesota DOC’s HCV management guidelines reportedly admit only 7 of 1,500 HCV-positive prisoners for treatment each year.

Because the new HCV drugs are allegedly being denied due to non-medical reasons (i.e., cost) despite being the current standard of care for hepatitis C, the lawsuit argues the DOC’s failure to provide the new drugs constitutes deliberate indifference in violation of the Eighth and Fourteenth Amendments. The suit also raises claims under the Americans with Disabilities Act and Rehabilitation Act.

Ligons and Michaelson are represented by attorney Peter Nickitas, litigation director of the International Humanitarian Law Institute. See: Ligons v. MN Department of Corrections, U.S.D.C. (D. Minn.), Case No. 0:15-cv-02210-PJS-BRT.

Litigation over the failure of prison officials to provide access to the new generation of HCV drugs may be a new trend. On June 10, 2015 a similar lawsuit was filed against the Massachusetts DOC, noting that “Over 1,500 state prisoners in Massachusetts have Hepatitis C, but as of the present time only three are being treated for it.” The suit seeks class-action status and injunctive relief for HCV screening and adequate treatment for prisoners who are HCV-positive. See: Paszko v. O’Brien, U.S.D.C. (D. Mass.), Case No. 1:15-cv-12298-NMG.

Another class-action suit over the ability of prisoners to access the new HCV drugs was filed in Pennsylvania on June 12, 2015. See: Chimenti v. Penn. DOC, U.S.D.C.(E.D. Penn.), Case No. 2:15-cv-03333-JP.

PLN will report future developments in these cases.

Additional sources: www.forbes.com, www.sovaldi.com, www.viekira.com, International Humanitarian Law Institute press release (May 26, 2015)

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