United States District Court, District of Columbia
MEMORANDUM OPINION AND ORDER
P. Mehta United States District Judge
matter is before the court on Plaintiff Jean-Gabriel
Bernier's motion “for a preliminary injunction
directing [ ] [D]efendant BOP Chief Physician Jeff Allen to
provide Plaintiff with the drug treatment regimen of Harvoni;
[and directing] [D]efendant BOP Director Samuels to house
Plaintiff in a two-man cell.” Notice of Motion, ECF No.
For the reasons discussed below, the motion is denied.
First Cause of Action: Treatment for Hepatitis C
Plaintiff's Factual Allegations
“suffers from Hepatitis C, ” which he describes
as “a virus transmitted primarily through the blood . .
. which impairs the liver, ” and “ultimately
leads to cirrhosis” of the liver. Compl., ECF No. 1,
¶ 10. He believes that, if he were to “eradicate
the virus now, the liver damage already done . . . will most
likely be reversed and the painful symptoms which [he]
suffers as a result of the present liver damage will cease to
exist.” Id. ¶ 24. These symptoms include
“nausea, gastric dysfunction, chronic fatigue, night
sweats and insomnia.” Id.
alleges that, in October 2014, the Food and Drug
Administration granted Gilead Sciences, Inc., “approval
to market a drug named Harvoni for the cure of Hepatitis
C.” Id. ¶ 16. The drug is costly,
however. Plaintiff represents that “a once a day pill
cost[s] about $1, 000.00 each amounting to $94, 000.00 for a
twelve-week treatment.” Id. According to
Plaintiff, patients who, like him, are
“African-American, Genotype 1 (most difficult to
treat), prior null responder to previous treatment regimens,
” experience “amazing results” on Harvoni.
Id. ¶ 17.
Plaintiff returned to federal custody in June 2015, he was
designated to FCI Allenwood, a medium security institution.
See id. ¶¶ 18, 29. Based on “test results
which indicated cirrhosis from 2012, 2014 and 2015” and
“liver biopsy results from 2009 which showed Grade II,
Stage II liver conditions, ” he “requested
treatment with Harvoni.” Id. ¶
Medical staff at FCI Allenwood, in turn, submitted a
“request for treatment approval . . . to [D]efendant
BOP Chief Physician Allen.” Id. Dr. Allen
denied the request on the ground that “Plaintiff did
not meet the BOP priority criteria” based on certain,
but not all, of the test results Plaintiff submitted.
Id. ¶ 19.
belief that the high cost of Harvoni was the basis of Dr.
Allen's decision, Plaintiff asked for permission
“to participate in the Gilead Patient Assistance
Program which is offered by Gilead for those unable to afford
. . . the treatment.” Id. ¶ 25. According
to Plaintiff, BOP and Gilead officials conferred and
“decided that prisoners would not be allowed to
participate in the assistance program.” Id.
¶ 26. Nor has the BOP obtained other FDA-approved drugs
for the treatment of Hepatitis C that recently have become
available at a lower cost than Harvoni. Id. ¶
Stahl, D.O. (“Dr. Stahl”), a licensed physician
employed as the Clinical Director at FCI Allenwood, examined
Plaintiff on August 24, 2015, shortly after his arrival at
the facility. Fed. Defs.' Opp'n to Pl.'s Mot. for
Prelim. Inj., ECF No. 20, Ex. A, Decl. of Elizabete Stahl,
D.O., ECF No. 20-1 [hereinafter Stahl Decl.], ¶¶ 1,
3-4. According to Plaintiff's medical records, he had
been diagnosed with Hepatitis C; an ultrasound of his liver
had been done on January 1, 2013; and liver biopsies had been
done in 2004 and 2009, the latter of which rated his
condition as Grade 2, Stage IIB. Stahl Decl. ¶ 4.
Plaintiff's APRI (AST/Platelet Ratio Index) score-a
numerical method of measuring the risks associated with
Hepatitis C-was a 0.47, and his genotype was 1a. Id.
Although Plaintiff displayed no clinical symptoms of
cirrhosis at that time, Dr. Stahl ordered an updated
ultrasound, id., which was administered on September
28, 2015, id. ¶ 5. Plaintiff also underwent an
upper endoscopy on November 18, 2015. Id. Plaintiff
“was seen by [Dr. Stahl's] staff on September 29,
2015, and again on October 29, 2015, related to his Hepatitis
C condition.” Id. ¶ 6. In addition, on
November 2, 2015, a registered nurse discussed with Plaintiff
“the Hepatitis C Clinical Practice Guidelines and
algorithm and what lab data staff look at in determining
treatment priority levels.” Id.
to Dr. Stahl, “[t]he BOP has established priority
criteria to ensure that those [patients] with the greatest
need are identified and treated first.” Id.
¶ 7. Priority 1 patients, including those with
documented cirrhosis and an APRI score greater than two, are
the highest priority. Priority 4 patients are the lowest
priority. See id. Under this framework, Plaintiff is
a Priority 3 patient. Id. This group includes
“patients with Stage 2 fibrosis on liver biopsy [and
an] APRI score [of] 1.5 to <2[.]” Id.
six-month intervals, “the institution's infectious
disease nurse runs a roster of all patients with a
current/active diagnosis of Hepatitis C, and new APRI scores
are calculated on every Hepatitis C patient[ ] and submitted
to the clinical director/designee for review and
prioritization.” Id. ¶ 8. Only
“[p]atients with APRI scores >2 are scheduled to
meet with a medical provider and go over their
interest/willingness to submit to treatment.”
Id. Plaintiff's APRI score as of July 14, 2016,
was 0.32. Id.
December 22, 2015, a request for Harvoni anti-viral treatment
for Hepatitis C was submitted, ” presumably by
Plaintiff. Id. ¶ 9. At that time, Plaintiff had
an APRI score of 0.40. Id. The request was denied
because, absent evidence of advanced liver disease, Plaintiff
did not meet BOP's priority treatment criteria.
Id. As a Priority 3 patient, Dr. ...