*1 [934 741] NE2d NYS2d In the Matter of Robert v New York State Appellant, Wooley,
Department Respondent. Services, of Correctional 2, 2010;
Argued July June decided *2 COUNSEL POINTS OF (Alan Syracuse Estabrook, LLP, J. Pierce of Hancock & counsel), Department appellant. of Correctional Ser for The unanimously denying Wooley recom vices’ decision Robert hepatitis dis maintenance treatment for his C mended low dose rights ease his constitutional and is violates (Estelle capricious, affected error of law. v irrational and Goord, v 196 Misc 2d Gamble, 97; 429 US Matter Domenech of v 416; Pardus, 89; 20 AD3d Erickson v 551 US Johnson Supp Wright, La v 398; F 2d 412 F3d De Rosa State 234 of Scully, 1007; Matter Lucas v 71 NY2d York, New 173 Misc 2d of Correction, State 399; Matter Ronson v Commissioner of of of of Village Wright, 158; 488; 315 N.Y., 112 AD2d Brock v F3d Wegman’s Olech, 562; Food Mkts. v State v 528 US Willowbrook 95.) York, AD2d New of (Owen Albany Attorney Demuth, General, Cuomo, Andrew M. Spiegel Nancy A. of Underwood, Peter H. Barbara D. Schiff counsel), Department respondent. Ser- of Correctional for experi- unproved treat with an decision not to vices’ approved drug regimen the federal had not been mental Food and Administration was rational and consistent with Drug (Wilson Seiter, v Amendment to the US Constitution. Brennan, Farmer v Matter of Peckham 294; 825; 501 US Calogero, Hughes Doherty, v Matter v 424; 12 NY3d 5 NY3d of Urbach, Matter York v New Assn. Convenience Stores 100; of B., Matter Michael Forbes v 204; 299; NY2d 80 NY2d Edgar, Coughlin, Dean Tatta v v 262; 207; 112 F3d 804 F2d Vose, 53.) Dias v F F 308; 2d Supp Supp (Steven Legal Society, Banks, Aid John Boston City New York Zelermyer Legal Services, and Milton and Prisoners’ counsel), (Karen Murtagh-Monks Albany counsel), for Aid Soci- Legal ety York, of the City another, New amici curiae. I. The Department Correctional Services’ denial of C treat hepatitis ment was indifferent deliberately to Robert Wooley’s needs and therefore violated his to be free of cruel and right (Estelle Gamble, 429 US Matter of unusual punishment. 97; *3 Shomo v Zon, Matter v Goord, Scott 1227; 35 AD3d 32 AD3d of Goord, Matter v Matter Davis 638; 416; 20 AD3d of Domenech of Goord, v Matter Pullman, Jarvis v 889; 7 AD3d 297 AD2d of Bryant 842; Matter Brunelle, v Matter Smith 936; 284 AD2d of of Alves, v White, Matter Allah v 844; 282 AD2d 913; 243 AD2d of Matter v Leonardo, 489.) Moore 185 AD2d II. The arbitrary of and capricious standard is not an appropriate standard of review for prisoners’ constitutional claims of inadequate medical care but nevertheless, judged by standard, of Department Correctional Services’ denial of maintenance was therapy arbitrary, capricious, irrational and affected of by error law. (Cove Angello, Sise, v Matter Curtiss v 910; 71 NY2d of County Matter Parkinson v Columbia Dist. At 675; AD2d of torney, Fischer, Matter Patel v 52; 178 Misc 2d 1193; 67 AD3d of Matter Goord, Scott v Matter Altamore v 638; 32 AD3d of Nehorayoff Barrios-Paoli, Mills, Matter 378; 90 NY2d Bry Goord, Matter Davis v Matter 932; AD2d 889; 7 AD3d Brunelle, ant v Goord, Matter Amaker v 936; 284 AD2d 792.) AD2d
OPINION OF THE COURT J. Ciparick, case,
In this we must determine the denial of certain whether medical an by to inmate the New York State Depart- (DOCS) ment of Correctional Services and capri- cious, or violative of the Eighth Amendment’s proscription against cruel and unusual We conclude that it was punishment. neither.
I. custody Wooley in the Petitioner Robert has been incarcerated petitioner prior the late 1980s. Sometime to of DOCS since hepatitis diagnosed C, a viral infection which increases liver, cancer and often leads to cirrhosis of the the risk of liver ultimately, and, death. which can cause liver failure treating petitioner’s physician prescribed at DOCS In drugs—interferon and ribavirin—for course of combination lasting initially responded Petitioner well weeks. protocol medication, the standard treatment to the which was period, hepatitis C at the time. At the end of the treatment for petitioner’s hepatitis as to be undetect- C viral load was so low able. period
Shortly end, was to before the treatment the Chief Medical Officer for contacted Dr. Lester requesting months of the DOCS, letter, six additional treatment, low- combination followed interferon/ribavirin therapy. Petitioner submitted dose maintenance interferon support request; contended of his he also medical literature hepatitis fell the “hard to treat” that, because his C within therapy category, maintenance interferon could be low-dose progression only option slowing of his disease. Ac- for respond Wright cording petitioner, his Dr. did not to request. later, in wrote to months October
Several According Regional Medical Director. Stern, Marc a DOCS supporting tests, he had suffered letter and *4 following relapse with the cessation of treatment a interferon/ the combination He the continuation of ribavirin. therapy, replacing effective, a more standard interferon with petition- newly-developed pegylated the time interferon.1 At Drug request Administration retreatment, the Food and er’s for (FDA) pegylated approved interferon for re- the use of had not interferon/ribavirin, and after a course of standard rejected request petitioner’s use of the for such off-label2 DOCS drug. PEGASYS, interferon, is interferon with an ad- Pegylated also 1. called gives the glycol. “pegylation” polyethylene side chain of
ditional allowing injections. longer bioavailability, for fewer interferon a or medical device to the use of a medication 2. The term “off-label” refers (see approved it Buckman Co. for which the FDA other than that Plaintiffs’ Comm., Legal and examined Thereafter, consulting physician petitioner interferon and retreatment with pegylated recommended recommendation, treating petitioner’s Based on the ribavirin. from Dr. to re-treat Wright physician again approval course of pegylated with 48-week interferon/ribavirin with consulting expert,” “[his] combination After therapy. with pegylated re[-]treatment Dr. decided to Wright “approve to interferon and ribavirin for 48 weeks.” up treat- re-treatment, his As neared petitioner completion him that he would again, opined examined ing physician if pegylated benefit he continued on low-dose maintenance In a different staff physician, interferon. to correspondence Wright rejected therapy, the use of maintenance observ- the recommended ing supported studies, but that a to published “large study ongoing [was] Wright determine whether is value.” Dr. also noted: such ... If there is “Any experimental use would be this he about should something particular patient enrolled into an clinical trial in the com- approved FDA[-] [,] that could be considered.” munity
In a second noted that July consulting physician of cir- “[b]ecause mortal consequences progression [,] rhosis maintenance Seven months therapy proposed.” later, the same noted that blood test physician petitioner’s an load, revealed increased viral and he noted at the time ‘‘ that a of peg[ylated [m]aintenance interferon] dose would be a strategy reasonable to stave off to . . . cir- progression rhosis . . . This is an in that has literature approach support though [is] no means In a new liver proved.” biopsy liver, revealed mild inflammation and fibrosis but no cirrhosis.
In 2006, an disease examined April specialist infectious that consideration should be petitioner suggested given interferon, noting maintenance therapy pegylated for this al- published approach “[t]here evidence literature not FDA stud- though approved proven long[-]term [it is] In and recom- all, ies five doctors examined yet.” petitioner mended that he maintenance pegylated receive low-dose request place interferon. Dr. denied Wright again to file a on low-dose therapy, prompting *5 grievance, which DOCS denied. remedies,
After his administrative com- exhausting petitioner annul the determi- menced this CPLR article 78 proceeding denying grievance, alleging nation his the denial of his requested arbitrary capricious treatment was and violated right his Amendment free of cruel and unusual punishment. Supreme petition Court the denied and dismissed proceeding, reasoning deny the that DOCS’s determination to requested treatment was rational and did not constitute de- liberate indifference to condition violation of the Eighth Amendment. (61 [2009]). Appellate Division affirmed AD3d 1189 We (13
granted [2009]), appeal leave to NY3d 705 now affirm.
II. Petitioner contends that DOCS’s denial of his capricious. disagree. treatment was We Generally, proceeding, in a CPLR article 78 we examine by agency the action taken whether has rational basis (see e.g. Calogero, Matter Peckham v 12 NY3d of [2009]). mayWe overturn administrative action where it is “regard “taken without sound basis reason” or to the (id., citing facts” Matter Pell v Board Educ. Union of Free School Dist. No. Towns Scarsdale & Mamaron- County, eck, Westchester If we NY2d supported by a rational conclude “that the determination is [this [we] if basis, must sustain the determination even C]ourt reached a different result concludes that would have agency” (id., citing Matter than the one reached 231). Pell, 34 NY2d at Here, a rational basis exists for DOCS’s determination denying petitioner’s requested therapy. The use of maintenance long-term unproven the medication yet approved by FDA, studies and not as even those doctors suggested recognized. simply It who the maintenance deny the treat cannot be said that DOCS’s determination to Significantly, under ment lacked a rational basis. record was made after consideration of scores that the determination by Wright’s of the case, the facts as indicated denial ground published therapy on the that “no studies maintenance “experimen- th[e] supported] idea” and that it was therefore
281 complaint Accordingly, petitioner’s determination that the tal.”3 misplaced. policy4 application of DOCS a reflexive suggests that the treatment that To the extent varying weigh experimental, the we decline not be would It for our is sufficient in the medical literature. studies available consulting physicians treating petitioner’s purposes that proven yet recognized effective, and the treatment was that recognition the documented lack of conclude that such we pegylated consti- levels interferon success maintenance denying treat- for the DOCS determination tutes a rational basis protocol. non-FDA-approved ment III. requested the that denial of
Petitioner also contends DOCS’s punishment, as cruel and unusual treatment constitutes Eighth prohibited by the States Con- Amendment of United the Again, disagree. inmates stitution. we Prison “rely [their] prison treat medical authorities to on so, do those needs needs; if the authorities fail to cases, a failure will not be met. In the worst such linger- may actually produce physical ‘torture aor ing the immediate concern to death,’ evils most (Estelle Gamble, of the Amendment” drafters 103 [1976] [citation omitted]). may cases, “denial medical care result In less serious suffering penological purpose” [no] pain . . which . serve (id.). Supreme explained The has that United States Court provide Eighth requires prison “ade- that officials Amendment (see quate” Brennan, US care to inmates Farmer v medical [requested petitioner] of- 3. The “the treatment dissent observes that life-threatening against possibility protecting petitioner fers at least some 283). complains nothing in the (dissenting op The that illness” at dissent also “subject [petitioner] to would requested that record indicates (id. [emphasis add- any ed]). outweigh possible its medical risk that would benefits” examining ignores and the ultimate This the fact doctors maker, unanimously agreed that the treatment decision Despite apparent the dissent’s unproven and thus had no known benefits. hardly any all medical contrary, required to furnish belief to DOCS is marginally might prove benefi- an inmate even cial. “non-therapeutic prohibits medical Directive No. 0403 4. DOCS Research inmates], including drugs and use of unestablished experimentation [on (Available http://www.docs.state.ny.us/ unapproved techniques.” at Directives/0403.pdf.) A violation of the Amendment can be proven only prison if an inmate can demonstrate that officials [his her] have acted with “deliberate indifference to medical needs” serious omitted]). (Estelle, [citation US at comprised This “deliberate indifference” standard is of an e.g. (see objective component subjective component and a 2006]). [2d v Goord, Salahuddin 467 F3d 279-280 Cir objective component depriva- of the test examines whether the *7 (Farmer, “sufficiently tion of medical care was serious” 511 US 279). objective 832; at also Salahuddin, see F3d at 467 This component requires in turn the examination of two factors: prisoner actually deprived adequate First, “whether the was (Salahuddin, 279), care” medical F3d at and second, inadequacy sufficiently the in “whether (id. medical care is serious” 280). objective component Thus, at the of the standard is essentially inquiry. ques- In words, reasonableness other the response prison tion is whether the officials to the inmate’s objectively medical needs was the reasonable under circum- (see 279-280). stances id. at subjective component of the deliberate indifference stan- inquires charged act[ed] dard whether “the official . . . with a (id. sufficiently culpable citing state of mind” at Wilson v Seiter, The Second Circuit has explained subjective requirement this as follows: arising
“In medical-treatment cases not
from emer-
gency situations,
the official’s state of mind need
knowing
purposeful
not reach the
tion
level
inflic-
plaintiff proves
of harm;
it suffices if the
that
the official acted with deliberate indifference to
inmate health. Deliberate indifference is a mental
equivalent
subjective
state
as
recklessness,
the
term is used in criminal
This
law.
mental state
charged
requires that the
official act or fail to act
actually
while
aware of a substantial risk that seri-
(id. [citations
ous inmate harm will result”
omit-
ted]).
by prison
When
medical
determination made
official was
policy,
question
prison
in accordance with a
is whether “fol-
lowing
policy
[the
resulted
deliberate indifference to
(Brock Wright,
inmate’s]
[2d
medical needs”
v
315 F3d
[emphasis
2003]
Cir
added];
Petitioner seeks course treatment may “experimental,” lawfully he have. The FDA classifies it as prescribing patients. not from it for their but does forbid doctors Every petitioner—five all—agreed examined in that doctor who medically indicated. treatment was nevertheless refused to make the treatment available.
DOCS submissions me, Its reasons are not clear to either from DOCS’s interpretation majority opinion’s Indeed, it from the of them. or majority be, to or the is unclear to me whether DOCS claims acting or own. is, in interest its thinks it possible only petitioner’s considered, I see no If interests are undisputed, record, that It on this DOCS’s denial. is defense of possibility protecting the treatment offers at least some petitioner Nothing life-threatening against in rec- illness. suggests would he seeks that the course of treatment ord any endanger subject risk that would him to him, or possible outweigh its benefits. justify position by
DOCS has to its reference to its policy says: statement, own experimentation which “Medical or cosmetic pharmaceutical testing may not be (DOCS conducted on inmates.” Research Directive No. http://www.docs.state.ny.us/Directives/0403.pdf.) available at purpose policy prevent The of this is self-evident: to inmates being guinea pigs policy from used as in scientific research. application pharmaceutical company no has rational here. No laboratory trying research is use to test an to unproven product. supported by physicians Petitioner, five fa trying get case, miliar with his is for his own use a course of “experimental.” treatment that FDA has called It does not deny protect make sense to him that order to him being experimented from on.
I can conceive no rational basis for DOCS’s decision to with- suggest hold treatment is unless it to avoid the I do cost. cost, that consideration of even it when comes to treatment of dangerous surely point illnesses, is irrational. There is some at high, which the cost is so and the likelihood of patient reasonably low, benefit so that DOCS could decide expenditure public unjustified. that an is funds Perhaps is the case here. But DOCS has not said so. It justify grounds; has not tried to its decision on cost-benefit it has not even disclosed what thinks the treatment asking circumstances, for would cost. I Under cannot avoid conclusion DOCS has advanced no rational basis for the decision it made.
Judges Judge Read concur Pigott Cipar- Graffeo, Judge separate opinion Smith dissents Chief which ick; Judge Judge concur. Lippman Jones *9 affirmed, Order without costs.