Coleman v. State Supreme Court et al

Filing 55

REPORT AND RECOMMENDATIONS For the foregoing reasons, the motions of the City (Docket No. 14), the FDA (Docket No. 39), Lilly (Docket No. 42), and Ortho (Docket No. 50), should be granted in full; Bellevues motion (Docket No. 36) should be granted in sofar as it addresses Colemans constitutional claims; Colemans motion (Docket No. 48) should be denied; and Colemans malpractice claims should be dismissed without prejudice. SO ORDERED. Objections to R&R due by 3/15/2010 (Signed by Magistrate Judge Frank Maas on 2/25/2010) Copies Mailed By Chambers.(jmi)

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UNITED STATES DISTRICT COURT S O U T H E R N DISTRICT OF NEW YORK - - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- x J A S O N COLEMAN, P l a in tif f , - against (STATE) SUPREME COURT, PART OF M E N T A L HEALTH HYGIENE, FOOD A N D DRUG ADMINISTRATION (FDA), J A N S S E N , ELI LILLY AND COMPANY, ST. LUKE'S HOSPITAL, BELLEVUE H O S P I T A L CENTER, and CITY OF NEW YORK, D e f e n d a n ts . : : : : USDC SDNY DOCUMENT ELECTRONICALLY FILED DOC #: _________________ DATE FILED: 2/25/10 R E P O R T AND R E C O M M E N D A T IO N T O THE HONORABLE V IC T O R MARRERO 09 Civ. 1072 (VM)(FM) : : : : - - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- - -- x F R A N K MAAS, United States Magistrate Judge. In this case, pro se plaintiff Jason Coleman ("Coleman"), who has been d ia g n o se d as a paranoid schizophrenic, challenges the constitutionality of his placement in a program of assisted outpatient treatment ("AOT") pursuant to a court order issued u n d er Section 9.60 of the New York Mental Hygiene Law ("Section 9.60"), more c o m m o n ly known as "Kendra's Law." Coleman also contends that he experienced h a rm f u l side effects from the antipsychotic medications the court order required him to ta k e . He seeks to recover a total of $245 million in damages from seven defendants: the C ity of New York ("City"), the Food and Drug Administration ("FDA"), Eli Lilly and Company ("Lilly"), Ortho-McNeil-Janssen Pharmaceuticals, Inc. ("Ortho"),1 Saint L u k e 's Hospital ("St. Luke's"), Bellevue Hospital Center ("Bellevue"), and the Mental H yg ie n e Part ("MHP") of the New York State Supreme Court.2 (See Docket No. 1 (C o m p l. ¶¶ IV-V & Attach. ¶¶ 3(5), 5)). The City, Bellevue, and Lilly each have moved to dismiss Coleman's c o m p la in t for failure to state a claim pursuant to Rule 12(b)(6) of the Federal Rules of C iv i l Procedure. (Docket Nos. 14, 36, 42). Additionally, the FDA has moved to dismiss th e complaint for lack of subject matter jurisdiction pursuant to Rule 12(b)(1), and Ortho h a s moved for judgment on the pleadings pursuant to Rule 12(c). (Docket Nos. 39, 50). Finally, Coleman seeks reconsideration of this Court's prior denial of his motion for a d e f au lt judgment against MHP and Bellevue. (Docket No. 48). (St. Luke's has not filed a n y motion.) F o r the reasons set forth below, I recommend that the motions filed by the d e f en d a n ts be granted in part and denied in part, and that Coleman's motion for re c o n sid e ra tio n be denied. Additionally, because this disposition means that only state la w claims will remain in this suit, I recommend that those claims be dismissed without p r e ju d ic e . In his complaint, Coleman incorrectly identifies this defendant as "Janssen." (See Ortho Mem. at 1). The MHP of the State Supreme Court is named in the complaint as the State Supreme Court, Part of Mental Health Hygiene. 2 2 1 I. B a c k g ro u n d A. Kendra's Law In 1999, the New York State legislature enacted Section 9.60 following the tra g ic death of Kendra Webdale, who was pushed in front of a subway train by a man d ia g n o se d with paranoid schizophrenia who had failed to take his medications. See N .Y .S . Senate Mem. in Supp. of Kendra's Law, reproduced in 1999 N.Y. Sess. Laws 1 8 2 2 , 1825 (McKinney); In re K.L., 1 N.Y.3d 362, 366 (2004). The legislature su b seq u en tly extended the statute, with certain modifications, for five additional years p a st its original June 30, 2005 sunset date. See 2005 N.Y. Sess. Laws 137, 158 (M c K in n e y). Section 9.60 authorizes the New York courts to require that a patient "selfa d m in is te r psychotropic drugs or accept the administration of such drugs by authorized p e rs o n n e l." N.Y. Mental Health Law ("MHL") § 9.60(j)(4). This outpatient program has a number of components, including case management or case coordination services, m e d ic a tio n , substance abuse counseling and testing, and therapy. See id. § 9.60(a)(1). For a court to order AOT, an eligible petitioner ­ who may be a family m e m b e r , director of a hospital where the patient is hospitalized, parole officer, social w o rk e r, psychologist, psychiatrist, or county social services officer ­ must show by clear an d convincing evidence that seven statutory criteria have been met. Id. § 9.60(e)(1), (j)(3 ). These criteria are that the individual: · is eighteen years of age or older; 3 · · · is suffering from a mental illness; is unlikely to survive safely in the community without supervision; h a s a history of noncompliance with treatment for mental illness that p rio r to the filing of the petition has: ­ been a significant factor in necessitating hospitalization at least tw ic e within the last thirty-six months, or ­ resulted within the last forty-eight months in one or more acts of s e rio u s violent behavior toward himself or others, or threats of, or a tte m p t s at, serious physical harm to himself or others; · is, as a result of mental illness, unlikely to participate voluntarily in o u tp a tie n t treatment that would enable him to live safely in the c o m m u n i t y; is in need of AOT to prevent a relapse or deterioration that would be lik e ly to result in serious harm to himself or others; and is likely to benefit from AOT. · · Id. § 9.60(c). The petition also must include an affirmation from a physician (other than th e petitioner) that establishes that the physician has examined the patient and re c o m m e n d s AOT, or has not been able to examine him but has reason to suspect that he m e e ts the criteria for it to be imposed. Id. § 9.60(e)(3). If the patient refuses to consent to an examination by a physician and the court finds reasonable cause to believe that the a lle g a tio n s in the petition are true, the court may order law enforcement officials to take h im into custody and transport him to a hospital where he may be held for a maximum of tw e n ty-f o u r hours for an examination. Id. § 9.60(h)(3). 4 Absent good cause shown, a hearing must be held within three days of the s ta te court's receipt of the petition. Id. § 9.60(h)(1). The individual has the right to be re p re se n te d at the hearing and all other stages of the proceeding by the New York Mental H yg ie n e Legal Service 3 or private counsel. Id. § 9.60(g). At the hearing, a physician who h a s personally examined the subject of the hearing must testify in person. Id. § 9.60(h)(2). During that testimony, the physician must identify the facts supporting the a lleg a tio n that the patient meets each of the criteria for AOT and that such treatment is " th e least restrictive alternative." Id. § 9.60(h)(4). The physician also must detail the re c o m m e n d e d program of AOT and the rationale for that treatment. Id. The physician m u s t further "describe the types or classes of medication which should be authorized, . . . d e sc rib e the beneficial and detrimental physical and mental effects of such medication, a n d . . . recommend whether such medication should be self-administered or administered b y authorized personnel." Id. Section 9.60 also permits the patient to present evidence, c a ll witnesses, and cross-examine adverse witnesses. Id. § 9.60(h)(5). Assuming that an individual meets the statutory criteria, the court's ability to order AOT is further contingent upon the submission of a written treatment plan d ev elop ed by an appointed physician in consultation with the patient, the patient's Each judicial department in the State has a Mental Hygiene Legal Service to provide legal assistance to persons alleged to be in need of mental health care and their families. See MHL §§ 47.01, 47.03. 5 3 tr e a tin g physician, and, upon the patient's request, a significant other, such as a close frien d or relative. Id. § 9.60(i)(1)-(2). T h e period of any initial AOT order may not exceed six months. Id. § 9.60(j)(2). Thereafter, renewal of the AOT order may be sought for periods of up to o n e year. Id. § 9.60(k). An AOT order issued by the court may be reviewed in the same m a n n e r as an order directing that a person be involuntarily detained in a mental health f a cility. Id. § 9.60(m). Thus, the patient (or a relative or friend acting on his behalf) may s e e k review within thirty days, in which event a justice other than the one entering the A O T order must "cause a jury to be summoned." Id. § 9.35. Unless waived, the jury m u s t try the question of the patient's mental illness (and presumably the need for AOT). Id. Finally, when a physician determines that a patient has failed or refused to co m p ly with AOT despite efforts to induce compliance, and that the patient may require in v o lu n ta ry inpatient treatment, he may ask the director of the hospital providing the A O T , or the director of community services of a local governmental unit, to direct that the p a tien t be transported to a hospital and held for up to seventy-two hours to evaluate w h ethe r the patient should be committed as an inpatient. Id. § 9.60(n). Police officers a ls o may be directed to take the patient to an appropriate hospital for evaluation. Id. Significantly, Section 9.60 provides that the "[f]ailure to comply with an o rd e r of assisted outpatient treatment shall not be grounds for involuntary civil 6 c o m m itm e n t or a finding of contempt of court." Id. Thus, a physician cannot commit a p atien t merely because he has failed to comply with AOT. The physician may, however, c o n sid e r a patient's refusal to take required medications or comply with alcohol or drug tes tin g , or the failure of such tests, in determining whether further examination is n e c e s s a ry. Id. B. C o le m a n ' s Psychiatric History and Treatment4 C o le m a n was diagnosed with paranoid schizophrenia in late 2004. (See C o m p l. ¶¶ III(A)-(B); Decl. of Ass't Corp. Counsel Jacqueline Hui, dated Apr. 16, 2009 (" H u i Decl. I"), Ex. A; Affirm. of Scott Soloway, M.D., dated July 26, 2006, ¶¶ 4, 7). As a consequence of his failure to comply with his treatment, he was hospitalized at St. L u k e 's from October 4 to 27, 2004, July 31 to August 23, 2005, and May 3 to June 1, 2 0 0 6 . (Id. ¶ 6). On August 16, 2006, the director of the AOT program in Manhattan s u c c es s f u lly petitioned the MHP for an order requiring Coleman to participate in AOT for s ix months. (See Hui Decl. I Ex. A). The petition was based on Coleman's history of p a ra n o id schizophrenia and hospitalizations for treatment noncompliance. (Id.). Pursuant to the order, Coleman was required to participate in AOT at Bellevue, which is part of the Three of the defendants served Coleman with the notice required by Local Civil Rule 12.1, which warns him that the Court may rely on materials beyond his complaint. (See Docket Nos. 41, 44, 49). Moreover, Coleman himself has submitted additional materials in opposition to the defense motions. (See Docket Nos. 46, 47, 52, 54). For these reasons, the factual summary that follows relies on both Coleman's complaint and the additional materials submitted by the parties. 7 4 N e w York City Health and Hospitals Corporation. (See Compl. ¶ III(C); Compl. Attach. ¶ 3(1); Docket No. 31 (Decl. of Jacqueline Hui, Esq., dated June 2, 2009 ("Hui Decl. II"), ¶ 4)). On February 13, 2007, based on the AOT director's renewed petition, the M H P ordered Coleman to participate in AOT for an additional six months. (Hui Decl. I E x . B). The MHP issued additional orders requiring Coleman to participate in AOT for s ix - m o n th intervals on August 14, 2007, February 8, 2008, and August 5, 2008. (Id. Exs. C -E ). On February 16, 2009, Coleman "graduated" from the AOT program at B e lle v u e because of his compliance with his treatment plan. (Id. Ex. F). Despite the fact th a t he no longer is required to participate in AOT, Coleman has brought this action in an ef fo rt to recover money damages. (Compl. ¶ V). C. C o m p la in t In his complaint, Coleman contends that it is his right "as a U.S. citizen not to take meds if he doesn't want to." (Id. Attach. ¶ 3(1)). Coleman asserts that he n e v e rth e le ss was "forced to take medication and attend a program by [MHP]" though he h a d not "broken any laws [or] done anything to [him]self or anyone else." (Id. ¶ III(C)). He complains that the medication caused him to develop a heart problem and nausea and m a d e him feel worse, not better. (Id. ¶¶ III(C), IV). 8 C o le m a n further contends that the MHP violated his civil rights and the " P a tie n t Bill of Rights" 5 by directing that he take medication and attend a program w ith o u t affording him a jury trial, although he was neither incapacitated nor subject to a g u a rd ian sh ip . (Compl. Attach. ¶ 3(1)). Coleman alleges that he also was not permitted to s e e a health care provider other than the one appointed by MHP. (Id.). Coleman alleges that the FDA acted negligently by permitting Ortho and L illy to "put harmful medication on [the] market." (Id. at ¶ 3(2)). He similarly contends th a t these medications, which are intended to help people with mental illness, "only make . . . things worse (Alzheimer's Disease etc.)." (Id.). According to Coleman, the FDA " s h o u ld be paying attention to all medication." (Id.). With respect to Ortho, the manufacturer of Haldol and Risperdal, two of the a n tip s yc h o tic medications that Coleman's physician at St. Luke's allegedly prescribed, C o le m a n maintains that "[t]he medication has too many side effects," including nausea, h e a rt failure, Alzheimer's Disease, and "decreased sexual ability." (Compl. ¶ V & A tta c h . ¶ 3(3)). He also notes that women who are using the medication allegedly cannot b re a st feed. (Id.). For these reasons, he opines that the medications "do more harm than g o o d " and "shouldn't even be on the market." (Id.). Section 2803(1)(g) of the New York Public Health Law requires every general hospital in the state to make available to their patients a statement of patient rights and responsibilities promulgated by the Commissioner of Health. 9 5 C o lem a n similarly claims that Lilly was negligent because its antipsychotic m e d ic a tio n , Zyprexa, has side effects comparable to those associated with Risperdal and H a ld o l. (Compl. Attach. ¶ 3(4)). Coleman notes that he is further "concerned" that " [ p ]e o p le are being forced to take these meds [which] are not working as well as they s h o u ld ." (Id.). Coleman also alleges that he has "not been the same" since he began re c e iv in g treatment at St. Luke's in 2004, and that he has experienced "problems v o m itin g , concentrating,[and] sleeping," hears "voices occasionally in his head," and has " h e a rt problems." 6 (Id. ¶ 3(5)). F in a lly, Coleman asserts that if he failed to attend the AOT program or take h is medications, he would be arrested, "no matter where he is or what he is doing," and ta k e n to see a psychiatrist. (Id. Attach. ¶ 3(6&7)). He further complains that in such in s ta n c e s he has been charged for the use of ambulance services. (Id.). Liberally construed, Coleman's complaint can be read to allege that (1) the M H P , the City, and Bellevue violated his substantive and procedural due process rights u n d e r the New York and United States constitutions; (2) the FDA was negligent in allo w ing certain antipsychotic medications to be sold; (3) Ortho and Lilly failed to warn Coleman claims that St. Luke's "prescribed mental health medication without a diagnosis" and kept him against his will. (Id.). According to Coleman, St. Luke's further failed to provide any treatment for his heart problems and violated the Patient Bill of Rights. (Id.). 10 6 h im adequately about the side effects of their drugs; and (4) Bellevue and St. Luke's f a ile d to inform him of the side effects of the drugs their physicians prescribed. II. S ta n d a rd of Review A. M o t io n s to Dismiss U n d e r Rule 12(b)(1) of the Federal Rules of Civil Procedure, a complaint m u st be dismissed if a court lacks subject matter jurisdiction over the claims asserted. In re so lv in g the issue of subject matter jurisdiction, a court is not limited to the face of the c o m p la in t and may consider evidence outside the pleadings. Phifer v. City of New York, 2 8 9 F.3d 49, 55 (2d Cir. 2002). The plaintiff has the burden of proving by a p re p o n d e ra n c e of the evidence that subject matter jurisdiction exists. Id. (citing M a k a ro v a v. United States, 201 F.3d 110, 113 (2d Cir. 2000)); Shipping Fin. Servs. Corp. v . Drakos, 140 F.3d 129, 131 (2d Cir. 1998) ("jurisdiction must be shown affirmatively, a n d that showing is not made by drawing from the pleadings inferences favorable to the p a rty asserting it"). Under Rule 12(b)(6) of the Federal Rules, a court must dismiss a complaint th a t fails to state a claim upon which relief can be granted. In deciding a motion under R u le 12(b)(6), the Court must accept as true all factual allegations made in the complaint a n d draw all reasonable inferences in favor of the plaintiff. Leatherman v. Tarrant C o u n ty Narcotics Intelligence & Coordination Unit, 507 U.S. 163, 164 (1993); Newman & Schwartz v. Asplundh Tree Expert Co., 102 F.3d 660, 662 (2d Cir. 1996). The first of 11 th e se precepts, however, is inapplicable to legal conclusions couched as factual a lle g a tio n s , which the Court is "not bound to accept as true." Bell Atl. Corp. v. T w o m b ly, 550 U.S. 544, 555 (2007). As the Supreme Court has explained, the ultimate is s u e to be decided under Rule 12(b)(6) is whether the plaintiff's claims are "plausible." Id. at 556. Determining whether the allegations of a complaint nudge a plaintiff's claims a c ro s s the line from "conceivable to plausible" requires a court to "draw on its judicial e x p e rie n c e and common sense." Ashcroft v. Iqbal, __ U.S. __, 129 S. Ct. 1937, 1950-51 (2 0 0 9 ). B. M o tio n for Judgment on the Pleadings U n d e r Rule 12(c), judgment on the pleadings is appropriate when the m a te ria l facts are undisputed and a party is entitled to judgment as a matter of law based o n the contents of the pleadings. See, e.g., Sellers v. M.C. Floor Crafters, Inc., 842 F.2d 6 3 9 , 642 (2d Cir. 1988); Guy v. Astrue, 615 F. Supp. 2d 143, 158 (S.D.N.Y. 2009). "In d e c id in g a Rule 12(c) motion, [courts] apply the same standard as that applicable to a m o tio n under Rule 12(b)(6), accepting the allegations contained in the complaint as true a n d drawing all reasonable inferences in favor of the nonmoving party." Ziemba v. W e z n er, 366 F.3d 161, 163 (2d Cir. 2004) (quoting Burnette v. Carothers, 192 F.3d 52, 5 6 (2d Cir. 1999)). 12 C. P r o Se Plaintiffs W h e re , as here, a plaintiff is proceeding pro se, the Court is obligated to " r e a d his supporting papers liberally, and . . . interpret them to raise the strongest a rg u m e n ts that they suggest." Burgos v. Hopkins, 14 F.3d 787, 790 (2d Cir. 1994). Moreover, the Court may rely on the plaintiff's opposition papers as well as the complaint in assessing the legal sufficiency of his claims. See Crum v. Dodrill, 562 F. Supp. 2d 3 6 6 , 373 n.13 (N.D.N.Y. 2008) (citing Gadson v. Goord, No. 96 Civ. 7544 (SS), 1997 W L 714878, at *1, n.2 (S.D.N.Y. Nov. 17, 1997)). The Court also may consider any d o c u m e n t attached to the plaintiff's complaint or incorporated therein by reference. Chambers v. Time Warner, Inc., 282 F.3d 147, 152-53 (2d Cir. 2002). Even when a d o c u m e n t is not incorporated by reference, the Court may consider it in connection with a m o tio n to dismiss if the complaint "relies heavily upon its terms and effect." Id. at 153 (q u o tin g Int'l Audiotext Network, Inc. v. AT&T, 62 F.3d 69, 72 (2d Cir. 1995)). D. M o tio n for Reconsideration T h e standard for granting a motion for reconsideration "is strict, and re c o n sid e ra tio n will generally be denied unless the moving party can point to controlling d e c is io n s or data that the court overlooked ­ matters, in other words, that might re a s o n a b ly be expected to alter the conclusion reached by the court." Shrader v. CSX T r a n sp ., Inc., 70 F.3d 255, 257 (2d Cir. 1995) (citing Schonberger v. Serchuk, 742 F. S u p p . 108, 119 (S.D.N.Y. 1990)). A motion for reconsideration is not "an opportunity to 13 `re a rg u e those issues already considered when a party does not like the way the original m o tio n was resolved."' Am. Hotel Int'l Group Inc. v. One Beacon Ins. Co., No. 01 Civ. 0 6 5 4 (RCC), 2005 WL 1176122, at *1 (S.D.N.Y. May 18, 2005) (quoting In re H o u b ig a n t, Inc., 914 F. Supp. 997, 1001 (S.D.N.Y. 1996)). An abiding conviction that the issue was wrongly decided therefore is not enough to warrant reconsideration; rather, th e issue must have been wrongly decided because the court overlooked important d e c is io n s or facts. See id. at *2. III. C o le m a n 's Claims A. D u e Process Claims In his complaint, Coleman challenges the constitutionality of the AOT p ro g ra m . Specifically, he alleges that he was "forced to take medication and attend a p ro g ra m ." (Compl. ¶ III(C)). He further alleges that "Due Process was not followed c o rre c tly" because there was no jury, and because he "was not tempor[arily] insane nor h ad he done anything to anyone or himself; and was not incapacitated." (Id. ¶ II(B), A tta c h . ¶ 3(1)). These allegations, liberally construed, can be read to assert that Section 9 .6 0 : (a) violates the Due Process Clause of the New York State Constitution; (b) v io late s Coleman's substantive and procedural due process rights under the Fourteenth A m e n d m e n t to the United States Constitution; and (c) violates due process as applied to h im . 14 1. N e w York Constitutional Claim In In re K.L., 1 N.Y.3d 362 (2004), the New York Court of Appeals c o n c lu d e d that Section 9.60 does not violate a patient's due process rights. In the course o f doing so, the Court of Appeals distinguished AOT from the forcible administration of a n tip syc h o tic medications to persons involuntarily committed to inpatient psychiatric f a cilitie s, which procedure it previously had concluded, in Rivers v. Katz, 67 N.Y.2d 485 (1 9 8 6 ), was lawful in certain limited circumstances. See id. at 369. It therefore is useful to begin consideration of Coleman's due process rights under the New York Constitution w ith a discussion of Rivers. In Rivers, several patients involuntarily committed to the Harlem Valley P syc h iatric Center pursuant to an order of the Dutchess County Court sought a d e c l a ra to r y judgment that they could not be forced to take antipsychotic drugs against their wishes. 67 N.Y.2d at 491. The court recognized that New York law accorded every a d u lt of "sound mind" the "right to determine what shall be done with his own body . . . a n d to control the course of his medical treatment." Id. at 492 (citations omitted). Nevertheless, the court identified two circumstances in which the fundamental right to re je c t treatment must yield to the state's interest. First, when a patient "presents a danger to himself or other members of society . . . , the State may be warranted, in the exercise of its police power, in administering antipsychotic medication over the patient's objections." Id. at 495. The court cautioned that the interests of the state must be compelling, and that 15 th e police power would justify forcibly administering medication only temporarily, while th e emergency persisted. Id. at 496. Second, the court held that the forced administration of medical treatment m a y be justified when the state exercises its parens patriae powers to care for individuals w h o are unable to care adequately for themselves due to mental illness. Id. (citing A d d in g to n v. Texas, 441 U.S. 418, 426 (1979)). Nonetheless, the court rejected a broad v iew of that power, emphasizing that it may be invoked only when an individual is " in c a p ab le of making a competent decision concerning treatment on his own." Id. (q u o tin g Rogers v. Okin, 634 F.2d 650, 657 (1st Cir. 1980)). As the court explained, " th e re is considerable authority within the psychiatric community that from a medical p o in t of view no relationship necessarily exists between the need for commitment and the c a p a c ity to make treatment decisions since the presence of mental illness does not ipso f a c to warrant a finding of incompetency." Id. at 495. Consequently, "many patients, d e sp ite their mental illness are capable of making rational and knowledgeable decisions a b o u t [their] medications." Id. The court held that for the state to administer treatment f o rc ib ly when the police power is not implicated, the state therefore must show by clear a n d convincing evidence that the individual is incapable of making a treatment decision. Id. at 497. N e a rly twenty years later in In re K.L., the Court of Appeals distinguished th e forced administration of drugs to inpatients from AOT. The court reasoned that, 16 u n lik e the program at issue in Rivers, Section 9.60 "neither authorizes forcible medical tre a tm e n t in the first instance nor permits it as a consequence of noncompliance with c o u rt-o rd e re d AOT." In re K.L., 1 N.Y.2d at 369. In the court's view, the only c o n se q u e n c e of noncompliance with AOT is that a person may be committed for up to s e v e n ty-tw o hours while a physician evaluates whether he needs to be institutionalized. See id. at n.2. The court further held that it was not violative of due process for law e n f o rc e m e n t officers to seize a noncompliant individual and take him to a hospital for that p u rp o s e . Id. at 372-73. The court concluded that "the coercive force of the [AOT] order lies solely in the compulsion generally felt by law-abiding citizens to comply with court directives." Id. at 370. As a consequence, the court held that the "minimal restriction on the right to re f u se treatment" inherent in an AOT order was justified by "the state's compelling in te re sts in both its police and parens patriae powers." Id. at 371. T h e re f o re , to the extent that Coleman challenges the constitutionality of S e c tio n 9.60 under the New York State Constitution, his claim is clearly precluded by the C o u rt of Appeals decision in In re K.L. 2. F e d e ra l Constitutional Claim T h e City notes in its papers that Section 9.60 recently has withstood rational b a sis scrutiny in federal court. (See City Mem. at 13). While that is true, in the case cited b y the City, Mental Disability Law Clinic v. Hogan, 2008 WL 4104460 (E.D.N.Y. Aug. 17 2 8 , 2008), the late Judge Sifton was considering an equal protection challenge to the s ta tu te , not a due process challenge.7 Moreover, the plaintiffs were arguing for greater u s e of AOT, contending that the limitations in Section 9.60 on those eligible for o u tp a tie n t commitment resulted in the "unnecessary loss of physical liberty for many in d iv id u a ls ." Id. at *12. Consequently, this decision adds nothing to a discussion of C o le m a n 's due process rights under the United States Constitution. Although courts have considered programs requiring the involuntary a d m in is tra tio n of medication to inpatients, no federal court has addressed whether Section 9 .6 0 ­ or any other state's AOT program ­ comports with the Fourteenth Amendment due p ro c e ss rights of those who are ordered to participate.8 It nevertheless is clear that the The plaintiffs also alleged that Section 9.60 violated the Americans With Disabilities Act. Id. at *1. It bears mention that New York is one of over 40 states with some type of AOT program. See Samuel Jan Brakel & John M. Davis, Overriding Mental Health Treatment Refusals: How Much Process is "Due"?, 52 St. Louis U. L.J. 501, 578 (2008). Of these states, however, only thirteen specify different criteria for inpatient and outpatient treatment. See Steven Strang, Assisted Outpatient Treatment In Ohio: Is Jason's Law Life-Saving Legislation or a Rash Response?, 19 Health Matrix 247, 252 (2009); see also Illissa L. Watnik, A Constitutional Analysis of Kendra's Law: New York's Solution for Treatment of the Chronically Mentally Ill, 149 U. Pa. L. Rev. 1181, 1191 (2001). Of the thirteen states with different outpatient standards, most require a finding of either incompetency or that the individual is an imminent danger to himself or others, standards which are common in inpatient commitment statutes. See, e.g., Ala. Code § 22-52-10.2 ("unable to make a rational and informed decision"); Tex. Health & Safety Code Ann. § 574.034(b) (requiring "severe . . . distress," inability "to live safely in the community," and inability to participate voluntarily, each of which must be proved by a recent "overt act"); Va. Code Ann. § 37.2-817 (requiring either substantial likelihood of serious physical harm in the near future or incapacity). Very few states use a standard that reaches a substantially broader group of individuals than that used for inpatient commitment. Watnick, supra, at 1192. 18 8 7 q u e stio n presents "both substantive and procedural aspects." See Mills v. Rogers, 457 U .S . 291, 299 (1982). The substantive issue requires the Court to define the protected in te re st and identify the interests that might outweigh it. Id. The procedural issue relates to "the minimum procedures required by the Constitution for determining that the in d iv id u a l's liberty interest actually is outweighed in a particular instance." Id. As set f o rth below, courts typically have considered such issues in the context of programs in v o lv in g the forced medication of patients who are incarcerated or involuntarily civilly c o m m itte d . As these cases indicate, Coleman has not plausibly alleged that his in v o lv e m e n t in AOT violated either his substantive or his procedural rights under the Due P ro c e ss Clause of the Fourteenth Amendment. a. S u b s ta n t iv e Due Process i. C rim in a l Law Cases In Washington v. Harper, 494 U.S. 210, 221-22 (1990), the Supreme Court u n e q u iv o c a lly held that an inmate has a "significant liberty interest in avoiding the u n w a n te d administration of antipsychotic drugs under the Due Process Clause of the F o u r te e n th Amendment." The Court nevertheless rejected the inmate's suggestion that he c o u ld not be compelled to take such drugs unless "the factfinder makes a substituted ju d g m e n t that he, if competent, would consent to drug treatment." Id. at 222. Instead, the C o u rt held that the forcible administration of antipsychotic drugs is permissible in a p riso n environment "if the inmate is dangerous to himself or others and the treatment is in 19 th e inmate's medical interest." Id. at 227. At the same time, the Court acknowledged that th e use of these drugs could have "serious, even fatal side effects," including acute d ys to n ia (a severe involuntary spasm of the upper body), tardive dyskinesia (a potentiallyirre v e rs ib le disorder characterized by involuntary, uncontrollable movements of various m u s c le s), swelling of the brain, catatonic states, hypertension, nausea, vomiting, loss of a p p e tite , dry mouth, impotency, and blurred vision. Id. at 229-30 (majority opinion), 239 (B la c k m u n , J., concurring). Subsequently, in Riggins v. Nevada, 504 U.S. 127 (1992), a defendant co n v icted after his insanity defense failed sought review of his conviction on the theory th a t he should have been allowed to forgo continued medication for the duration of his tria l so that he could show the jurors his "true mental state." Id. at 130. Although the trial judge required that the medication be continued, his order failed to explain his re a so n in g . Id. at 131. Applying Harper, the Supreme Court held that requiring in v o lu n ta ry medication might have been justified if it was medically appropriate and, " c o n sid e rin g less intrusive alternatives, essential for the sake of Riggins' own safety or th e safety of others." Id. at 135. The Court also suggested that the State could have ju s tif ie d involuntary treatment "by establishing that it could not obtain an adjudication of R ig g in s ' guilt or innocence by using less intrusive means." Id. In the absence of any f in d in g s that might support either basis for forced medication, the Court reversed the c o n v ic tio n . Id. at 138. 20 In Sell v. United States, 539 U.S. 166 (2003), a pretrial detainee sought to o v e rtu rn an order requiring that he be forcibly medicated in an effort to render him c o m p e te n t to stand trial. The Supreme Court held that "only an `essential' or `overriding' sta te interest" could overcome an individual's constitutionally-protected interest in a v o id i n g forced medication. Id. at 178-79. Consequently, it is only in "rare" instances, w h e re the "treatment is medically appropriate, is substantially unlikely to have side e f f e c ts that may undermine the fairness of the trial, and, taking account of less intrusive a lte rn a tiv e s, is necessary . . . to further important governmental trial-related interests, that a person may be medicated so that he can be tried." Id. at 179. Significantly, the Court su g g e ste d that before seeking to justify forced medication on these bases, a court should d e ter m in e whether it is warranted for a "different purpose, such as the purposes set out in H a rp e r related to the individual's dangerousness, or . . . where refusal to take drugs puts h is health gravely at risk." Id. at 181-82. ii. C a se s Involving Civilly-Committed Plaintiffs S in c e Harper, a few courts have applied the dangerousness standard in the fa ce of substantive due process challenges by civilly-committed patients who were in v o lu n ta rily medicated. The earliest such decision is Cochran v. Dysart, 965 F.2d 649 (8 th Cir. 1992). There, a federal prisoner held beyond the expiration of his sentence by re a so n of mental defect challenged both his continued commitment and the forced a d m in is tra tio n of psychotropic drugs. Id. at 649. The record contained a report by a 21 r e v ie w in g psychiatrist who approved the medication because the treating psychiatrist c o n sid e re d the plaintiff "dangerous to himself and others without medication," although th e treating psychiatrist also noted that the plaintiff, when properly medicated, was "able to function [in] open population." Id. at 650. The report further opined that the p lain tiff 's paranoid schizophrenia was a condition that would "respond to treatment with n e u ro le p tic medication [which would] eventually help [him] improve his reality testing." Id. Concluding that any justification for forced medication other than dangerousness m ig h t not pass muster under Harper, the Eighth Circuit remanded the case, instructing the d is tric t court to obtain and review the underlying documents on which the reviewing p syc h iatris t relied. Id. at 651. Subsequently, in Morgan v. Rabun, 128 F.3d 694, 697 (8th C ir. 1997), the Eighth Circuit again applied the Harper standard to a civilly-committed p a tien t because "governmental interests in running a state mental hospital are similar in m a te ria l aspects to that of running a prison." In Preston v. Gutierrez, No. 90-6029-CV-SJ-6, 1993 WL 280819 (W.D. M o . Jul 23, 1993), a plaintiff was committed to the custody of the Missouri Department o f Mental Health after pleading not guilty to a criminal charge by reason of mental defect. Id. at *1. Relying on Cochran and an earlier Eighth Circuit case, United States v. Watson, 8 9 3 F.2d 970 (8th Cir. 1990), the court held that the Due Process Clause of the Fourteenth A m e n d m e n t "requires that officials exercise more than just professional judgment when in v o lu n ta rily medicating involuntary mental patients[;] they must exercise professional 22 ju d g m e n t that the medication is necessary to insure the safety of the patient or others." Preston, 1993 WL 280819, at *11. Accordingly, the court invalidated the applicable M is s o u ri policy to the extent that it did not require such a finding. Hightower by Dahler v. Olmstead, 959 F. Supp. 1549, 1562 (N.D. Ga. 1 9 9 6 ), involved a challenge to the involuntary administration of antipsychotic drugs to p e rs o n s who were hospitalized in accordance with Georgia law because they presented a "su b stan tial risk of imminent harm" to themselves or others, or were "so unable" to care f o r their own "physical health and safety as to create an imminently life endangering c risis." Id. at 1553. Balancing the state's parens patriae and police power interests a g a in s t the patient's liberty interest in avoiding forced medication, the court concluded th a t the Georgia procedures comported with the requirements of substantive due process. Id. at 1562. In reaching this determination, the court noted that permitting the members o f the plaintiff class to refuse antipsychotic drugs might lead to the infringement of the co n stitutio n al rights of others, including staff members and other patients. Id. The court a lso relied upon the plaintiffs' failure to show that there were more appropriate means to a c co m p lis h the state's interests. Id. F in ally, in Jurasek v. Utah State Hospital, 158 F.3d 506, 511 (10th Cir. 1 9 9 8 ), the Tenth Circuit considered a state hospital policy authorizing the forced m e d ic a tio n of a civilly-committed mental patient if the patient was "gravely disabled" or p o s e d a threat of serious physical harm to himself or others or their property. Id. at 509. 23 A gravely disabled patient was defined as one who is "in danger of serious physical h a rm " or who manifests (or will manifest) "severe deterioration in routine function" re la tiv e to cognitive or volitional control. Id. at 511. The court rejected the view that H a rp e r should be limited to a prison context, noting that Riggins had applied the same s ta n d a rd to a pretrial detainee. The court further concluded that a patient who is in danger o f serious physical harm and is not receiving care essential to mitigate that risk "is, by d e f in itio n , in need of treatment for the sake of [his or her] own safety." Id. at 512 (c ita tio n and internal quotation marks omitted); see also Graves v. Mid-Hudson, No. C V -0 4 -3 9 5 7 (FB) (LB), 2006 WL 3103293, at *4 (E.D.N.Y. Nov. 2, 2006) (noting a g re e m e n t with Jurasek). iii. A p p lic a tio n to Section 9.60 A s the Supreme Court recognized in Harper, Riggins, and Sell, Coleman u n q u e stio n a b ly has a liberty interest in avoiding the forced administration of a n tip s yc h o tic s. Moreover, only an "essential" interest on the part of the state can override th a t liberty interest. Sell, 539 U.S. at 178-79. While Section 9.60 does not expressly state that outpatients must be a d a n g e r to themselves or the community before they can be ordered to participate in AOT, th e statute requires a finding by the MHP that they are "unlikely to survive safely in the c o m m u n ity" without AOT, and that they have a history of noncompliance with mental h e a lth treatment that has within the past several years resulted either in hospitalization or 24 v io le n t behavior toward themselves or others, or the threatened or attempted infliction of s e rio u s physical harm on themselves or others. MHL § 9.60(c). The statute also requires th a t the MHP find, before permitting AOT, that the patients are unlikely to participate v o lu n ta rily in outpatient treatments that "would enable [them] to live safely in the c o m m u n ity" and that AOT is necessary to "prevent a relapse or deterioration which w o u ld be likely to result in serious harm to [themselves] or others." 9 Id. § 9.60(c)(5), (6) (e m p h a s is added). Section 9.60 therefore essentially requires a finding of dangerousness ­ e ith e r to the patient or others ­ before a New York court can require someone to p a rticip a te in AOT. Section 9.60 further requires the state court to find that the patient is " lik e ly to benefit from [AOT]." Id. at 9.60(c)(7). The showing required by the statute c o n s e q u e n tly is fully consistent with Harper and its progeny. M o re o v e r, the limitations on a patient's liberty interests effected by an AOT o rd e r are considerably less invasive than those considered in Harper, Riggins, and Sell. As the New York Court of Appeals recognized, Section 9.60 authorizes the MHP to order A O T patients to take antipsychotic medication, and they may face consequences if they d o not comply. Unlike the statutes considered in prior cases, however, Section 9.60 does The MHL defines "likely to result in serious harm" to mean: "(a) a substantial risk of physical harm to the person as manifested by threats of or attempts at suicide or serious bodily harm or other conduct demonstrating that the person is dangerous to himself or herself, or (b) a substantial risk of physical harm to other persons as manifested by homicidal or other violent behavior by which others are placed in reasonable fear of serious physical harm." Id. § 9.01. 25 9 n o t allow AOT patients to be forcibly injected with medications against their will.10 A d d ition ally, participation in AOT enables individuals who are at high risk of involuntary h o s p ita liz a tio n to remain in the community as outpatients, an alternative which is far p re f e ra b le , as the plaintiffs in Hogan recognized. In sum, although Coleman concededly has a liberty interest in avoiding the f o rc e d administration of medication, Section 9.60 furthers important government in te re sts , requires medication only where medically appropriate, and is less intrusive than altern ativ e methods of ensuring the safety of the community and mentally ill patients. It f o llo w s that the state court, the City, and Bellevue did not violate Coleman's substantive d u e process rights under the Fourteenth Amendment by requiring participation in AOT. b. P r o c e d u r a l Due Process In his complaint, Coleman also claims that "[d]ue [p]rocess was not f o llo w e d correctly" and that his case was impermissibly heard by the MHP without a jury. (Compl. ¶¶ II(B), III(C)). This language, liberally construed, is sufficient to allege a p ro c e d u ra l due process claim under the Fourteenth Amendment. To establish such a claim, a plaintiff first must show that he was deprived of a liberty or property interest. See Bd. of Regents of State Colleges v. Roth, 408 U.S. 564, 5 7 1 (1972); Finley v. Giacobbe, 79 F.3d 1285, 1296 (2d Cir. 1996). If such a deprivation 10 Admittedly, the likely practical consequence of a refusal to submit to AOT would be involuntary commitment, assuming an individual meets the criteria in MHL § 9.01. Once the person is committed, the hospital would of course have to abide by the more stringent criteria laid out in Rivers v. Katz if it wished to compel forcible medication. 26 o c c u rre d , the Court then must consider what process was due and whether it was p ro v id e d . See Matthews v. Eldridge, 424 U.S. 319, 333-34 (1976). As noted above, there is no question that Coleman had a constitutionallyp r o te c te d liberty interest in not being forcibly medicated with psychotropic drugs against h is will. Sell, 539 U.S. at 178; Riggins, 504 U.S. at 134-35; Harper, 494 U.S. at 221-22. Accordingly, the principal issue before this Court is whether Section 9.60 afforded C o le m a n adequate procedural protections. If so, the Court also must consider whether th o s e procedural protections, in fact, were made available to him. See Project Release v. P rev o st, 722 F.2d 960, 970 (2d Cir. 1983). In Project Release, the Second Circuit considered these issues in the context o f a different provision of the MHL permitting the forced administration of antipsychotic m e d ic a tio n to civilly-committed inpatients prior to a judicial commitment hearing. The p l a in t if f s argued that the nonconsensual administration of such drugs in those c irc u m s ta n c es violated their "liberty interest in personal and bodily integrity" and d im in is h e d their ability to "participate effectively" in hearings. Id. at 977. The case came b e f o re the Court of Appeals after the district court granted partial summary judgment to th e state defendants with respect to the claims of a plaintiff initially admitted as an inp atien t on an emergency basis (under MHL § 9.39), later converted to a voluntary in p a tie n t (under MHL § 9.13), and eventually held involuntarily (under MHL § 9.27) a f te r she sought to leave the hospital. Id. at 964. 27 U n d e r New York regulations, different standards apply to each type of p atien t. See N.Y. Comp. Codes R. & Regs. tit. 14, § 27.8. Thus, patients who are c o m m itte d voluntarily or on an emergency basis may be given antipsychotic drugs over th e ir objection only in emergency situations where "treatment appears necessary to avoid s e rio u s harm to life or limb of the patients themselves." Id. § 27.8(b)(1). Involuntarilyc o m m itte d patients may not be medicated over their objection unless the head of service a p p ro v e s and, in the event of an appeal, the facility director concurs that treatment is w a rra n ted . Id. § 27.8(b)(3), (c). A patient who is committed voluntarily has no right to a p p e al, however, because the facility director may discharge him with a recommendation fo r outpatient treatment or, if appropriate, take the steps necessary to pursue involuntary c o m m itm e n t under MHL § 9.27. Id. § 27.8(b)(2). Although Project Release was decided before Harper, the Second Circuit c o rre c tly prognosticated that the Supreme Court would find that patients had a liberty in te re st in refusing antipsychotic medications. Project Release, 722 F.2d at 979. The c o u rt found it unnecessary to resolve that issue, however, because "such an interest can be c re a te d as a matter of state law, and the New York regulations established that right." Id. T u rn in g to the question "whether an involuntarily committed mental p a tie n t's right to refuse treatment with antipsychotic medication is sufficiently protected b y New York State procedures," the Second Circuit concluded that to be adequate those p ro c e d u re s "must at least provide sufficient opportunity for professional input." Id. at 28 9 1 7 -8 0 . Since the relevant New York regulations provided for several levels of review by m e d ic a l personnel, see id. at 980 (citing N.Y. Comp. Codes R. & Regs. tit. 14, §§ 27.8, 2 7 .9 ) , the court denied relief. Id. at 980-81. The court also rejected the plaintiffs' s u g g e stio n that prior judicial review was required, stating that "due process requires an o p p o rtu n ity for hearing and review of a decision to administer antipsychotic medication ­ b u t such a hearing need not be judicial in nature." Id. at 981 (emphasis added). Section 9.60 plainly provides for medical input before any AOT order is iss u e d . Indeed, a petition seeking AOT must be supported by the affirmation or affidavit o f a physician who either has examined the patient or certifies that he or his designee w e re unable to persuade the patient to submit to an examination. MHL § 9.60(e)(i)-(ii). Additionally, the state court cannot direct AOT unless a physician who has personally e x a m in e d the patient testifies at the hearing. Id. § 9.60(h)(2). During that testimony, the p h ys ic ia n must provide extensive detail supporting the petitioner's application and e sta b lis h that AOT is "the least restrictive alternative." Id. § 9.60(h)(4).1 1 As noted p re v io u s ly, if the patient declines to submit to a medical examination, the statute provides a means for the patient to be forcibly taken to a hospital for that purpose. See id. § 9.60(h)(3). In light of these extensive procedural protections, which not only require p ro f e ss io n a l input, but permit patients to challenge the medical testimony proffered by the Section 9.60 also entitles the patient to be represented at the hearing by the Mental Hygiene Legal Service and to participate fully in the hearing. Id. § 9.60(g), (h)(5). 29 11 p e titio n e r and adduce additional evidence of their own, Coleman cannot seriously contend th a t Section 9.60 fails to require adequate professional input before an AOT order is is s u e d by the MHP. Moreover, Section 9.60 expressly requires that a judicial hearing be h e ld before such an order issues and permits a patient to seek review before a second ju s tic e of the New York Supreme Court and a jury. Accordingly, even if due process re q u ire s the involvement of a court before a patient is directed to comply with AOT ­ w h ich it does not ­ Section 9.60 plainly comports with that requirement. In his complaint, Coleman nevertheless alleges that his case "was heard and ju d g e d without a jury." (Compl. ¶ III(C)). However, Section 9.60 permits a patient (or h is relative or friend) to seek judicial review by petitioning a justice of the Supreme Court o th e r than the one who issued the AOT order. Moreover, if such a petition is filed, the ju s tic e receiving it must "cause a jury to be summoned" so that the issue can be tried, u n les s a jury is waived. MHL §§ 9.35, 9.60(m). Coleman therefore had the opportunity to have his objections to AOT presented to a jury. Nowhere in his papers does he indicate th a t either he or his representative ever requested a rehearing before a different justice, m u c h less that a jury be summoned. In the absence of such a request, the mere fact that th e orders issued by the MHP were not reviewed elsewhere in the state court system does n o t give rise to a procedural due process violation. T h e procedures set forth in Section 9.60 therefore are adequate to withstand a facial due process challenge under the Fourteenth Amendment. Moreover, Coleman has 30 n o t alleged any facts which indicate that those procedures either were unavailable to him o r were misapplied.1 2 Cf. Project Release, 722 F.2d at 970 (noting that the case seems "to b e illustrative of the application of the statute, rather than its misapplication"). It follows th a t both the MHP and the City are entitled to the dismissal of Coleman's claims against th e m .1 3 B. FD A In his complaint, Coleman alleges that the FDA is liable for money d a m a g e s for "putting such harmful medication on [the] medicine market. (Compl. ¶ V). He further claims that there is sufficient evidence of the side effects of the medicines that w e re part of his AOT plan to require that they be taken off the market and that "it is In his complaint, Coleman does allege that "[t]reatment still continues by force without Supreme Court ruling." (Compl. Attach. ¶ 3(1)). This statement, however, is wholly conclusory and simply not plausible in light of the records submitted by the City, which confirm that Coleman graduated from the AOT program in early 2009. See Twombly, 550 U.S. at 55556. By letter dated February 15, 2010, Coleman seeks an extension of time to serve the MHP, which was not served within the 120-day period required by Rule 4(m) of the Federal Rules of Civil Procedure. This application should be denied for at least four reasons. First, Coleman has not shown good cause for the delay, as Rule 4(m) requires. Second, even if the MHP had been served, Coleman's claims against it would have to be dismissed because, as shown above, he has not pleaded a plausible due process claim for which it could be liable. Third, even if Coleman could show that the MHP violated his rights, a judicial arm of the state is not a "person" subject to suit under 42 U.S.C. § 1983. See Zuckerman v. App. Div., Second Dep't, Supreme Court of State of N.Y., 421 F.2d 625, 626 (2d Cir. 1970). Finally, even if the MHP were a "person" subject to suit in a civil rights action, the court clearly acted within the scope of its judicial functions and therefore would be entitled to judicial immunity. See, e.g., Pierson v. Ray, 386 U.S. 547, 553-54 (1967) ("Few doctrines were more solidly established at common law than the immunity of judges from liability for damages for acts committed within their judicial jurisdiction."); Peker v. Steglich, 324 F. App'x 38, 39 (2d Cir. 2009) ("Under New York State law, judges are absolutely immune for acts undertaken in performance of their judicial function."). 31 13 12 n e g lig e n t not to do such." (See Docket No. 46) (Affirm. in Opp'n to FDA's Mot. to D is m is s , dated June 24, 2009). Although Coleman contends that he has the "right to bring a lawsuit [] a g a in s t anyone federal or otherwise in [f]ederal [c]ourt," (see id.), the law says no such th i n g . Rather, to bring an action against a federal agency, such as the FDA, Coleman first m u s t establish a basis for overcoming sovereign immunity. United States v. Mitchell, 445 U .S . 535, 538 (1980). This requires him to show that the United States has " u n e q u iv o c a lly" expressed in a statute its willingness to be sued. Lane v. Pena, 518 U.S. 1 8 7 , 192 (1996); United States v. Shaw, 309 U.S. 495, 500-01 (1940). Here, Coleman m ig h t intend to rely upon either of two statutes: the Federal Food, Drug, and Cosmetic A c t ("FDCA") and the Federal Tort Claims Act ("FTCA"). On the facts of this case, n e ith e r permits Coleman to sue the FDA. 1. FDCA T h e FDCA "comprehensively regulates the introduction of new drugs into in te rs ta te commerce." In re Zyprexa Prods. Liab. Litigation, No. 04 MDL 1596, 2007 W L 2332544, at *1 (E.D.N.Y. Aug. 15, 2007); see Vermont v. Leavitt, 405 F. Supp. 2d 4 6 6 , 473 (D. Vt. 2005) ("The FDCA creates a `closed' system in which the FDA re g u la te s the manufacture, marketing and labeling of drugs sold in the United States."). Under the FDCA, however, there is no private right of action. See 21 U.S.C. § 337(a) (" a ll such proceedings for the enforcement, or to restrain violations, of this chapter shall 32 b e by and in the name of the United States"); PDK Labs, Inc. v. Friedlander, 103 F.3d 1 1 0 5 , 1113 (2d Cir. 1997). The FDCA consequently does not provide a basis for C o le m a n to pursue claims against the FDA in this suit. 2. FTC A The FTCA authorizes civil actions for monetary damages to be brought w h e n "personal injury or death [is] caused by the negligent or wrongful act or omission of a n y employee of the Government while acting within the scope of his office or e m p lo ym e n t" and the circumstances are such that the United States would be liable if it w e re a private party. 28 U.S.C. § 1346(b)(1). Because the FDA's actions in regulating p h a rm a c eu tic a ls are not of the type that a private party could undertake, the FTCA does n o t authorize the claims that Coleman seeks to bring against the FDA. See, e.g., Dorking G e n e tics v. United States, 76 F.3d 1261, 1266 (2d Cir. 1996) (FTCA is inapplicable to d ire c t violations of statutes by the government); C.P. Chem. Co. v. United States, 810 F .2 d 34, 37-38 (2d Cir. 1987) ("[Q]uasi-legislative or quasi-adjudicative action by an a g e n cy of the federal government is action of the type that private persons could not en g ag e in and hence could not be liable for under local law."). C o n se q u e n tly, because Congress has not subjected the FDA to lawsuits u n d e r the FDCA or FTCA, Coleman's claims against that agency must be dismissed for la c k of subject matter jurisdiction. See United States v. Sherwood, 312 U.S. 584, 586-87 33 (1 9 4 1 ); Williams v. United States, 947 F.2d 37, 39 (2d Cir. 1991); F.D.I.C. v. Meyer, 510 U .S . 471, 477 (1994). C. L illy and Ortho L illy and Ortho manufacture the drugs that Coleman was prescribed. In his c o m p lain t, Coleman sets forth a litany of adverse reactions that he and others allegedly h a v e suffered as a consequence of taking Haldol and Risperdal (manufactured by Ortho) a n d Zyprexa (manufactured by Lilly). (See Compl. ¶¶ III(C), IV & Attach. ¶ 3). The a d v e rs e reactions that he claims to have experienced include heart problems, nausea, w e ig h t gain, hearing voices, and difficulty concentrating and sleeping. Coleman contends th a t he did not have any of these difficulties until he began AOT, and that the m a n u f a c tu re r's drugs therefore should not be on the market. (See id.). Liberally c o n stru e d , his complaint seeks to state product liability claims against Ortho and Lilly b a s e d on their alleged failure to provide him with adequate warnings. The Second Circuit has summarized the law of New York applicable to s u c h claims as follows: [ A ] drug manufacturer, like any other manufacturer, can be h e ld liable for a defective product under the theory of strict p ro d u cts liability. Unlike most other products, however, e th ica l or prescription drugs may cause untoward side effects d e sp ite the fact that they have been carefully and properly m a n u f a c tu r e d . For purposes of strict products liability, these d ru g s , aptly described as "[u]navoidably unsafe products[,"] a re not deemed defective or unreasonably dangerous so long a s they are accompanied by proper directions for use and a d e q u a te warnings as to potential side effects. 34 L in d s a y v. Ortho Pharm. Co., 637 F.2d 87, 90 (2d Cir. 1980) (citation and internal p a re n th e se s omitted). A plaintiff who seeks to recover against a drug manufacturer on a p ro d u c ts liability theory also "must prove that the drug caused her injury and that the m a n u f ac tu re r breached a duty to warn of the possibility that the injurious reaction might o c c u r." Id. at 90-91. A s s u m in g that Coleman suffered each of the adverse reactions he describes, to state a claim on a failure-to-warn theory he still must show that Ortho or Lilly failed to p ro v id e adequate warnings of these potential side effects of their drugs. The m a n u f ac tu re r's duty, however, is "to warn the doctor, not the patient." Id. at 91. As the S e c o n d Circuit has explained, the "doctor acts as an `informed intermediary' between the m a n u f ac tu re r and the patient, evaluating the patient's needs, assessing the risks and b e n e f its of available drugs, prescribing one, and supervising its use." Id. In assessing the adequacy of the warnings given, the Court can take judicial n o tic e of the description of pharmaceutical drugs in the Physicians' Desk Reference (" P D R " ). See, e.g., Ariola v. Onondaga County Sheriff's Dep't, 2007 WL 119453, at *7 n .6 1 (N.D.N.Y. Jan. 10, 2007). As the PDR establishes, well prior to the advent of C o lem a n 's AOT, each of the side effects he claims to have suffered was fully disclosed to p h ys ic ia n s . For example, the 2001 edition of the PDR disclosed that Risperdal may cause " o r th o s ta tic hypotension associated with dizziness, tachycardia, and in some patients, 35 s yn c o p e ," 1 4 "somnolence," "impair[ed] judgment, thinking or motor skills," and that p re m a r k e tin g assessments further indicated a risk of increased dream activity, diminished s e x u a l desire and erectile dysfunction, nervousness, diarrhea, and fatigue. Physicians' D esk Reference, 1580-83 (55th ed. 2001). T h e 2001 PDR further discloses that Haldol may cause "Parkinson-like s ym p to m s ," insomnia, restlessness, anxiety, agitation, drowsiness, confusion, grand mal seizu res, catatonic-like behavioral states, diarrhea, vomiting, nausea, and numerous heart p ro b le m s . Id. at 2334-36. Indeed, the 2001 PDR states that "[c]ases of sudden and u n e x p e cte d death have been reported in association with the administration of [Haldol]." Id. at 2336. T h e 2001 PDR entry for Zyprexa cautions physicians about the risk of irre g u la r pulse or blood pressure, dizziness, tachycardia, syncope, somnolence, and im p a ire d thinking. Id. at 1788-93. In view of these extensive warnings, Coleman cannot plausibly allege that h is treating physicians were not cautioned about the side effects of the Ortho and Lilly d ru g s about which he complains. Indeed, on each occasion that the MHP ordered that C o le m a n submit to AOT, the physician's treatment plan submitted in support of the p e titio n specifically noted that Coleman's potential adverse side effects might include Orthostatic hypotension is a "form of low blood pressure that occurs in a standing position." Stedman's Medical Dictionary, (27th Ed. 2000). Syncope is a "loss of consciousness and postural tone caused by diminished cerebral blood flow." Id. 36 14 a n tic h o lin e rg ic effects,1 5 extrapyramidal effects,1 6 tardive dyskinesia,1 7 sedation, weight g ain, and orthostatic hypotension. (See Hui Decl. I Exs. A-E). A n y conceivable doubt in this regard is dispelled by Coleman's opposition p a p e rs, which concede that the "doctors that were in care of [him] knew the side effects o f [the] medication discussed in this case." (Docket No. 52 (Coleman Affirm. in Opp'n to Ortho Mot.) at 1). The fact that Coleman himself was not warned, even if established, d o e s not entitle him to proceed against Ortho or Lilly in light of the "informed in te rm e d ia ry" rule and the undisputed fact that his physicians were fully aware of the m a n y possible side effects of the antipsychotic drugs they prescribed for him. D. B ellev u e and St. Luke's L ib e ra lly construed, Coleman's complaint alleges a state law claim that B e llev u e and St. Luke's (or their doctors) committed malpractice by failing to secure his in f o rm e d consent before medicating him with psychotropic drugs. In New York, this An anticholinergic effect is one that is antagonistic to the passage of impulses through the parasympathetic or other cholinergic nerve fibers. Stedman's. Extrapyramidal side effects include tremor, akathisia (movement disorders characterized by inner restlessness and the inability to sit or stand still), slurred speech, dystonia (involuntary muscle contractions which sometimes are painful), bradyphrenia (slowing of thought processes), bradykinesia (slowing of movement), and muscular rigidity. See Extrapyramidal Side Effects, http://bipolar.about.com/od/glossary/g/gl_extrapyramid.htm (last visited Feb. 24, 2010). Tardive dyskinesia may result in "involuntary repetitive tic-like movements . . . primarily in the facial muscles or (less commonly) the limbs, fingers and toes. The hips and torso may also be affected." See Tardive Dyskinesia Introduction and Overview, http://www.tardivedyskinesia.com (last visited Feb. 24, 2010); see also Harper, 494 U.S. at 230. 37 17 16 15 c a u s e of action is statutorily defined. See N.Y. Pub. Health Law § 2805-d. Accordingly, C o le m a n must establish "the failure of the person providing the professional treatment . . . to disclose . . . alternatives thereto and the reasonably foreseeable risks and benefits in v o lv e d as a reasonable medical . . . practitioner under similar circumstances would have d is c lo s e d , in a manner permitting the patient to make a knowledgeable evaluation. Id. § 2805-d(1). Coleman also must show "that a reasonably prudent person in [his] position w o u ld not have undergone the treatment or diagnosis if he had been fully informed and th a t the lack of informed consent is a proximate cause of the injury or condition for which re c o v ery is sought." Id. at § 2805-d(3). The cause of action further is limited to nonem erg en cy cases. Id. at § 2805-d(2). A federal court may exercise supplemental jurisdiction over such a state law c laim when a federal claim vests the court with subject matter jurisdiction and the state a n d federal claims "derive from a common nucleus of operative fact." United Mine W o rk e rs of Am. v. Gibbs, 383 U.S. 715, 725 (1966). A federal court also has the d is c re tio n to retain a pendent state claim after dismissing a plaintiff's federal claims on th e merits prior to trial, but it must consider "the values of judicial economy, c o n v e n ie n c e, fairness, and comity in order to decide whether to exercise jurisdiction." Carnegie-Mellon Univ. v. Cohill, 484 U.S. 343, 350 (1988); 28 U.S.C. § 1367(c)(3). "[I]n the usual case in which all federal-law claims are eliminated before trial, the balance o f factors . . . will point toward declining to exercise jurisdiction over the remaining 38 s ta te -la w claims." Carnegie-Mellon Univ., 484 U.S. at 350 n.7; see also Klein & Co. F u tu re s, Inc. v. Bd. of Trade of City of N.Y., 464 F.3d 255, 262 (2d Cir. 2006) ("It is well s e ttle d that where . . . the federal claims are eliminated in the early stages of litigation, c o u rts should generally decline to exercise pendent jurisdiction over remaining state law c la im s ." ). Coleman has not shown that there is any reason why the Court should d e p a rt from the usual rule in this case. Accordingly, because each of Coleman's federal c la im s is subject to dismissal for the reasons set forth above, his state law claims against B e llev u e and St. Luke's should be dismissed without prejudice to his refiling in state

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